louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05547659: Multimodal and Unimodal Analgesia in Cholecystectomy
Official title: Comparison Between Multimodal and Unimodal Analgesia in Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Compare Unimodal and Multimodal Analgesics
Lead sponsor: October 6 University
Sponsor class: OTHER
Collaborators: name: Beni-Suef University
First posted: 2022-09-21
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Many surgical procedures are accompanied by postoperative pain with severity moderate, severe or extreme and insufficient postoperative pain control may cause risk of post-surgical complications and risk of chronic post-surgical pain The targets of preoperative pain management are to relieve patient suffering, reduce length of hospital stay and achieve early mobilization after surgery, decreasing opioid consumption and its side effects that are constipation, nausea, vomiting, dizziness, respiratory depression which is the most feared complication being life-threatening and some less common side effects as sedation


Eligibility criteria: Inclusion Criteria:

* Patients undergoing laparoscopic cholecystectomy
* Patients older than 18 years old

Exclusion Criteria:

* Renal or hepatic or cardiac impairment patients
* Patients with chronic pain history
* Allergic patients after taking aspirin or other NSAIDs
* patients with active gastrointestinal bleeding, ulcer and inflammatory bowel diseases or cerebrovascular bleeding

Primary outcomes:
measure: Postoperative visual analogue scale (VAS)
timeFrame: 24 hour postoperative
measure: Amount of post operative Needed opioid analgesia
timeFrame: 24 hour postoperative
Secondary outcomes:
measure: Type and amount of prescribed post operative non opioid analgesia
timeFrame: 24 hour postoperative
Other outcomes:
measure: Reported opioid side effects
timeFrame: 24 hour postoperative
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni suef University hospital
city: Banī Suwayf
country: Egypt
facility: Beni-Suef Hospital
Study officials:
References:
Clinical trial NCT02553759: Observed Actions in Chronic Neck Pain
Official title: Influence of the Actions Observed on Cervical Motion in Patients With Chronic Neck Pain. Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: observed action
range of motion
mirror neuron
Lead sponsor: AG Clinic
Sponsor class: OTHER
Collaborators: name: Hospital Universitario La Paz
First posted: 2015-09-18
Enrollment: 28
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 aim of the present protocol is to prove if the observed actions (AOb) will improve the cervical range of motion (CROM) in patients with non-specific chronic neck pain (CNP). This study is a parallel-group double blind randomized clinical. Outcome measures were CROM, and pressure pain detection thresholds (PPDT) with a digital algometer. The follow-up will consist of three evaluations: pre- treatment, post-treatment and 10 minutes after second measurement (motor imagery).


Eligibility criteria: Inclusion Criteria:

* Non specific chronic neck pain
* Diagnosed by medical specialist

Exclusion Criteria:

* cervical osteoarthritis or polyarthrosis
* rheumatic disease
* history of cervical hernia
* whiplash syndrome
* surgery on the neck, face or shoulders,
* systemic disease, medical history of cancer
* significant trauma that the patient relates to their pain and/or refusal to participate

Primary outcomes:
measure: Range of motion degrees
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitario La Paz
name: Alfonso Gil-Martínez, Master
role: STUDY_DIRECTOR
References:
Clinical trial NCT01270659: Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury
Official title: Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain: The FAIRTOP II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Fentanyl buccal tablet
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2011-01-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary purpose of this study is to evaluate fentanyl buccal tablet (FBT) for analgesia in comparison to standard analgesia, to determine if the FBT allows for faster achievement of "significant analgesia"

Detailed description: The subjects/patients will be asked if they would desire a low dose or high dose pain medication regimen. The low dose (low-FBT) group will receive FBT at a dose of 100 mcg, as well as an oral (pill) placebo preparation. The low dose (low-control) group will receive an "inactive comparator" (lansoprazole rapidly-dissolving buccal 15mg, " FBT placebo") and a dose of 5/325 Percocet tablet (oxycodone/acetaminophen 5/325). The high dose (high-FBT) group will receive 200 mcg FBT plus 2 placebo tablets. The high dose (high-control) group will receive the "FBT placebo" and a dose of 2, 5/325 Percocet tablets.

Eligibility criteria: Inclusion Criteria:

* pain sufficient to warrant medication stronger than acetaminophen (Tylenol) or aspirin
* only if Emergency Department provider approves
* a negative pregnancy test is required for participation for women of childbearing age

Exclusion Criteria:

* If treating provider determines intravenous analgesia is required
* allergy to acetaminophen or any opiate/opioid, or lansoprazole patients currently taking phenothiazines, CNS depressants (including alcohol), or if they have taken an monoamine oxidase inhibitor (MAOI) or selective serotonin reuptake inhibitor (SSRI) in the past two weeks
* if patient has already been administered an opioid analgesic for their current injury
* patients on chronic opioids therapy or a history of opioid abuse
* breastfeeding mothers
* patients who plan to drive home after their emergency department visit
* history of phenylketonuria (due to phenylalanine in the formulation of the lansoprazole solutab)

Primary outcomes:
measure: Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level)
timeFrame: 60 minutes
Secondary outcomes:
measure: Nausea Level
timeFrame: every 5 minutes for the first 60 minutes
measure: Number of Participants Experiencing Any Adverse Events
timeFrame: Full 2 hours of the study period
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Hillcrest Medical Center Emergency Department
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Stephen H Thomas, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklahoma
name: Annette O Arthur, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01013259: Immunomodulation of E.Coli Nissle 1917 in Patients With Grass Pollen Rhinoconjunctivitis
Official title: Explorative Analysis of the Immunomodulatory Capacities of Apathogenic Escherichia Coli Nissle 1917 in Patients With Rhinoconjunctivitis Due to Grass Pollen Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinoconjunctivitis
Keywords: E.coli
Mutaflor
grass pollen
rhinoconjunctivitis
rhinoconjunctivitis caused by grass pollen
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Due to the worldwide increasing prevalence of the allergic rhinoconjunctivitis, new therapeutical strategies are needed. The symptomatic treatment with topical and systemic antihistamines and corticosteroids are often insufficient. E.coli Nissle 1917 has immunomodulatory capacities and reveals less side effects. E.coli Nissle 1917 has no sedative properties and exhibits no hepatotoxic qualities. Thus, E.coli Nissle 1917 represents a new relevant therapeutical agent.


Eligibility criteria: Inclusion Criteria:

* clinical relevant grass pollen allergy with required treatment since 2 years
* positive skin prick test to grass
* positive sIgE towards grass (CAP 2)
* written informed consent

Exclusion Criteria:

* perennial rhinoconjunctivitis
* sinusitis
* chronic diarrhoea and other existing severe gastrointestinal diseases
* current specific immunotherapy to grass pollen

Primary outcomes:
measure: symptom-medication score
timeFrame: 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Margitta Worm, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06092359: The Eye in Orbit: UCF Adaption
Official title: The Eye in Orbit- Analysis of the Anatomical and Functional Ocular Changes Related to Space Flights: UCF Adaptation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spaceflight Associated Neuro-Ocular Syndrome
SANS
Keywords: SANS
Spaceflight Associated Neuro-Ocular Syndrome
Optical Coherence Tomography Angiography
OCTA
Space
Astronaut
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study necessarily had a very specific population. The study only enrolled astronauts in the AX1/Rakia mission, which was scheduled for space flight in late March 2022.

Brief summary: The goal of this study is to understand the impact of space travel on the eyes. Space flight impacts numerous aspects of ocular anatomy and physiology. Current hypotheses are based on pressure changes within and around the optic nerve. Retinal and choroid blood drainage may be affected by microgravity associated cerebrospinal fluid pressure changes. Recently, a new imaging modality, Optical Coherence Tomography Angiography (OCTA), has been able to reveal micro vascular changes in the retina and choroid. To date, no microgravity ocular imaging tests have been published using OCTA. In this study the researchers aim to describe microgravity circadian choroidal and retinal vasculature using multimodal imaging including OCTA to better understand space associated ocular changes.


Eligibility criteria: Inclusion Criteria:

- astronauts in the AX1/Rakia mission, which was scheduled for space flight in late March 2022.

Exclusion Criteria:

* adults unable to consent
* individuals who are not yet adults (infants, children, teenagers) -
* pregnant women
* prisoners.

Primary outcomes:
measure: To examine early changes in ocular physiology following exposure to microgravity and asses these changes as risk factor for Spaceflight Associated Neuro-Ocular Syndrome (SANS).
timeFrame: 4 months
measure: Asses early changes in ocular physiology as risk factor for Spaceflight Associated Neuro-Ocular Syndrome (SANS).
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Mehul Patel, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01775059: Collection of Performance Data From the Integrated Sensor and Infusion Set. TRIAL 4
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus Type I
Diabetes Mellitus Type II
Lead sponsor: Medtronic Diabetes R&D Denmark
Sponsor class: INDUSTRY
First posted: 2013-01-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center, non-randomized, and interventional study in which subjects will use the Integrated sensor and infusion set with MiniLink Transmitter and the Medtronic Paradigm® VEO™ insulin pump (Sensor augmented pump) for 15 days.

The purpose of this study is to collect performance data on the Integrated sensor and infusion set for approximately 15 days, with the intention for each subject to wear 5 sets for 3 days each.


Eligibility criteria: Inclusion Criteria:

* Subject is 18 years of age or older at time of screening
* Subject has a clinical diagnosis of insulin requiring diabetes, as determined by investigator.
* Subject is currently using a Medtronic Paradigm Sensor Augmented insulin pump and has been so for a minimum of 3 months at time of enrollment.
* Subject has Continuous Glucose Monitoring experience (min 30% of CGM use within the month prior to enrollment).
* Subject has an average of 3 SMBG per day (verified via CareLink) during the month prior to enrollment.
* Subject is willing to wear the study devices for the duration of the study
* Subject is willing to perform frequent (min 7 per day) SMBGs during study device wear
* Subject is willing to keep a short diary during the device wear.

Exclusion Criteria:

* Female subject is pregnant, per urine pregnancy test performed at time of enrollment in women of child bearing age.
* Female subject plans to become pregnant during the course of the study.
* Subject is unable to tolerate tape adhesive in the area of the placement of the study device.
* Subject has any unresolved adverse skin condition in the area of the placement of the study device (e.g. psoriasis, rash, Staphylococcus infection).
* The subject is not deemed to be an appropriate candidate for the study by the investigator for any reason.

Primary outcomes:
measure: Accuracy endpoint
timeFrame: 5 months
measure: Safety endpoint
timeFrame: 5 months
Secondary outcomes:
measure: Accuracy endpoint
timeFrame: 5 months
Other outcomes:
measure: Accuracy endpoint
timeFrame: 5 months
Locations:
city: Fredericia
country: Denmark
facility: Fredericia Hospital
city: Hilleroed
country: Denmark
facility: Hilleroed Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
affiliation: Hilleroed Hospital
name: Ulrik Pedersen-Bjergaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04950959: XACT ACE Observational Registry
Official title: Observational Post-Market Study of the XACT ACE Robotic System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tumors
Keywords: CT-guided percutaneous procedure
Percutaneous biopsy
XACT ACE Robotic System
Lead sponsor: Xact Robotics Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects undergoing CT guided, minimally invasive percutaneous procedures in an interventional radiology setting.

Brief summary: Compile real world data on the use of the XACT ACE Robotic System

Detailed description: The purpose of this observational post-market study is to compile real world data on the use of the XACT ACE Robotic System in subjects undergoing CT guided, minimally invasive percutaneous procedures.

The objectives are to 1) evaluate the proportion of procedures in which the instrument reached the pre-defined target, based on the physician's determination and CT imaging confirmation, 2) To evaluate system accuracy defined as the measured distance from the tip of the instrument to the target location at the at the end of the instrument insertion, and 3) Incidence of intra- and post-procedural adverse events.

Up to 500 patients will be enrolled in this multicenter, nonrandomized, single arm registry.

Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years of age
2. Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the interventional radiology suite
3. Subject is willing to sign informed consent for the purposes of data collection

Exclusion Criteria:

1. No exclusion criteria other than listed in the product Instructions for Use (IFU)

Primary outcomes:
measure: Proportion of successful procedures
timeFrame: 1 hour
measure: System accuracy
timeFrame: 1 hour
measure: Assessment of Safety
timeFrame: 2 hours post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
Study officials:
affiliation: XACT Robotics
name: Mark Macedo
role: STUDY_DIRECTOR
References:
Clinical trial NCT01253759: Long Term Results of Combined Transpupillary Thermotherapy (TTT) Indocyanine Green (ICG) Based Photodynamic Therapy (PDT) in Choroidal Melanoma
Official title: 10 Years Report of Combined Simultaneous Transpupillary Thermotherapy and ICG-based Photodynamic Therapy for Choroidal Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Choroidal Melanoma
Keywords: Transpupillary thermotherapy
Choroidal melanoma
ICG-Photodynamic therapy
Lead sponsor: New England Retina Associates
Sponsor class: OTHER
First posted: 2010-12-03
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects selected from retina specialist general patient population.

Brief summary: This is a report of 10 years results of combined Transpupillary thermotherapy (TTT) treatment with Indocyanine green (ICG) in controlling small and medium-sized choroidal melanomas.

Detailed description: The study was done in a Clinical practice setting. Forty six eyes of 46 patients with small or medium-sized choroidal melanomas were treated with i-TTT using infrared light delivered from a diode laser. All patients were evaluated to rule out systemic metastasis and underwent a complete ophthalmological evaluation including: Slit lamp biomicroscopy, dilated fundus examination, Fluorescein angiography, Optical coherence tomography and A/B ultrasonography. Main outcome measures were: Changes in visual acuity, complications associated with the treatment and local control of the tumor.

Eligibility criteria: Inclusion Criteria:

* Small and medium-sized choroidal melanoma
* Patients older than 18 years old.
* Patients who can read and signed the informed consent.

Exclusion Criteria:

* Patients with ocular inflammation.
* Patients with another active ocular disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamden
country: United States
facility: New England Retina Associates
state: Connecticut
Study officials:
affiliation: New England Retina Associates
name: Peter E Liggett, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04390659: Myomectomy During Cesarean Section Is This Aright Decision
Official title: Myomectomy During Cesarean Section,Is This Aright Decision
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstetric Labor, Premature
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 45
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: c s with uterine myoma

Brief summary: myomectomy was done during cesarean section

Detailed description: The myomectomy was done by conventional technique but timing of myomectomy either before or after delivery of the baby varied between different cases .Infusion of oxytocin during the operation and for 24 h later.

Eligibility criteria: Inclusion Criteria:

* women with diagnosed uterine myoma prior to pregnancy
* needed cesarean sections for various indications.
* Women with diagnosed uterine myoma during pregnancy and needed cesarean sections for various indications.
* Women with myoma diagnosed incidentally during labour.

Exclusion Criteria:

* Refusal of the women at any time before and during the operations.
* Cervical myoma.
* Atonic uterus after delivery of the baby.
* Women with bleeding disorders due to medical or obstetric causes.

Primary outcomes:
measure: difficulty of cesarean myomectomy
timeFrame: during the procedure/surgery"
Secondary outcomes:
measure: 4concentrations of hemoglobin
timeFrame: during the procedure
Other outcomes:
Locations:
Study officials:
affiliation: Benha University
name: khalid salama
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ledee-Bataille N, Lapree-Delage G, Taupin JL, Dubanchet S, Frydman R, Chaouat G. Concentration of leukaemia inhibitory factor (LIF) in uterine flushing fluid is highly predictive of embryo implantation. Hum Reprod. 2002 Jan;17(1):213-8. doi: 10.1093/humrep/17.1.213.
Clinical trial NCT05660759: Comparison of N-butyl-cyanoacrylate and Micro Parti-cles Effect in Inducing Liver Hypertrophy After PVE
Official title: N-butyl-cyanoacrylate Glue Versus Micro Particles and the Effect on Inducing Liver Hypertrophy After Portal Vein Embolization- a Retrospective Swedish Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Portal Vein Embolization, Liver, Hypertrophy
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
name: Skane University Hospital
First posted: 2022-12-21
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing portal vein embolization during the study period 2013 - 2021 in Linköping University Hospital, Karolinska Comprehensive Cancer Center and Skåne University Hospital Lund.

Brief summary: The aim of this study is to compare hypertrophy of the FLR after PVE with microparticles to hypertrophy after PVE with cyanoacrylate in a material large enough to answer the study question. In addition, other factors that may influence the degree of hypertrophy will be evaluated in a multivariable analysis.

The hypothesis is: PVE with cyanoacrylate is superior to PVE with microparticles in terms of FLR hy-pertrophy.

Detailed description: With expansion of indications for major liver surgery, portal vein embolization (PVE) is increasingly used in order to induce hypertrophy of the future liver remnant (FLR). De-spite vide variety of materials available to occlude the portal veins the most commonly used are cyanoacrylate and microparticles/spheres. Earlier studies have failed to show superiority of one over the other in terms of hypertrophy of the FLR while PVE with cy-anoacrylate seems to be less time consuming. Two small previous studies from single centers have shown greater growth by cyanoacrylate compared to particles (1) with 90 included patients and the second study with 34 included patients (2), but larger reviews have failed (3). Cyanoacrylate might give a more robust FLR hypertrophy (4) . The main problem in evaluating previous studies has been the large heterogeneity and the often poorly described study populations.

Eligibility criteria: Inclusion Criteria: Over 18 years old. Planned for portal vein embolization. -

Exclusion Criteria:

-

Primary outcomes:
measure: FLR hypertrophy
timeFrame: Spring 2023
Secondary outcomes:
measure: Degree of hypertrophy
timeFrame: Spring 2023
measure: Kinetic growth rate
timeFrame: Spring 2023
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University Hospital
Study officials:
affiliation: Linkoeping University
name: Bergthor Björnsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: