louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04339244: Effect of Pressure Regulation on Optic Nerve Sheath Diameter
Official title: Effect of Arterial Pressure Regulation on Optic Nerve Sheath Diameter During Robot Assisted Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Optic Nerve Sheath Diameter
Keywords: arterial pressure regulation
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 51
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intracranial pressure is known to increase during robot-assisted laparoscopic radical prostatectomy (RALRP) due to steep trendelenberg position. Measurement of optic nerve sheath diameter (ONSD) is a indirect method which can assess the degree of intracranial pressure.

This study is designed to measure the ONSD during RALRP under regulation of arterial pressure.

Detailed description: During last decades, RALRP has been advocated due to the advantages of short hospital stay, reduced blood loss during surgery, less postoperative pain and complication. During RALRP, steep trendelenberg postion and pneumoperitoneum are required essentially, and this is for the acquisition of adequite surgical field. However, such position and pneumoperitoneum can result in harmful hemodynamic change. Previous study demonstrated that patients of RALRP showed 12.5% increase of ONSD.

The relationship of ONSD and increase of intracranial pressure has been proved previously through many studies. Recent meta analysis showed that ONSD measurement for the monitor of ICP demonstrated that sensitivity 0.9, specificity 0.85 and ROC cuve 0.983.

In addition, increase of ONSD during RALRP can be affected by the degree of arterial pressure and end tidal CO2 increase.

This study is designed to see the effect of arterial pressure regulation on the increase of ONSD

Eligibility criteria: Inclusion Criteria:

* Prostate cancer receiving RALRP

Exclusion Criteria:

* glaucoma
* intracranial tumor
* previous disease elevating intracranial pressure

Primary outcomes:
measure: optic nerve sheath diameter change among 4 time period
timeFrame: Baseline, 1 hour, 2 hours, 2.5 hours after completion of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Hong ji HEE
Study officials:
affiliation: 82532584892
name: Sung Won Jung, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03442244: Skin Irritation of LEO 90100 Foam (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects
Official title: Skin Irritation Trial of LEO 90100 Foam (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2018-02-22
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This trial is looking at whether the LEO 90100 foam causes irritation of the skin in healthy Japanese male adults without psoriasis. A single application of LEO 90100 foam and its vehicle will each be made to 2 body sites in 20 subjects.


Eligibility criteria: Key Inclusion Criteria:

* Signed informed consent has been obtained.
* Healthy Japanese male subjects.
* Aged 20 to 40 years inclusive.

Key Exclusion Criteria:

* Body Mass Index outside the range 18-25 kg/m²
* Use of any medication (systemic or topical) within 2 weeks of Day 1.

Primary outcomes:
measure: Skin irritation
timeFrame: Up to Day 4
measure: Photo irritation
timeFrame: Up to Day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Medical Co. LTA HAKATA clinic
Study officials:
affiliation: LEO Pharma
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03118544: REduction of Contrast Via DyeVert Used in CTO Procedures
Official title: REduction of Contrast Via DyeVert Used in CTO Procedures (REDUCe)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Total Occlusion of Coronary Artery
Keywords: Chronic Total Occlusion
Coronary Artery Disease
Percutaneous Coronary Intervention
CTO
PCI
Lead sponsor: Minneapolis Heart Institute Foundation
Sponsor class: OTHER
Collaborators: name: Osprey Medical, Inc
First posted: 2017-04-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing clinically-indicated chronic total occlusion (CTO) percutaneous coronary intervention (PCI)

Brief summary: The is an observational, prospective study to evaluate the effect of the DyeVert System on contrast volume administration in patients undergoing clinically-indicated chronic total occlusion (CTO) percutaneous coronary intervention (PCI)

Detailed description: The DyeVert System is a disposable, FDA-approved device that interfaces with standard manifold systems to reduce the amount of contrast used in catheterization procedures, while maintaining fluoroscopic image opacity.

No study has assessed use of the system in CTO PCI. It would be expected that savings in CTO procedures may be less than non-CTO procedures due to catheter sizing and number of open guide injections required. Open guide injections through larger catheters do not provide for the as much resistance, therefore decreasing the need for contrast to be diverted

Eligibility criteria: Inclusion Criteria:

1. Subjects undergoing CTO PCI at each of the participating centers.
2. Contrast volume recorded during CTO PCI
3. Subjects included in the "Multicenter Registry of Chronic Total Occlusion Interventions" study (Allina IRB approval # 948134-1)

Exclusion Criteria:

None

Primary outcomes:
measure: Contrast volume administration during CTO PCI
timeFrame: During the CTO PCI procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
Study officials:
References:
Clinical trial NCT02637544: Treatment Efficiency of Acupuncture in Non Chronified Pain Patients With TMDs
Official title: Wirksamkeit Von Akupunktur Auf Den Nicht Chronifizierten Schmerz Bei Craniomandibulärer Dysfunktion - Eine Randomisierte, Placebokontrollierte Klinische Studie
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Temporomandibular Disorders
Lead sponsor: University of Heidelberg Medical Center
Sponsor class: OTHER
First posted: 2015-12-22
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: Aim of this randomized clinical trial is to examine the treatment effectiveness of an acupuncture protocol in adult patients with non chronified TMDs.

Detailed description: Therefore there are two treatment arms, acupuncture verum and acupuncture placebo. Investigators will evaluate for 4 weeks primary current pain, secondary the unassisted jaw opening.

Eligibility criteria: Inclusion Criteria:

* non chronified TMD pain
* written informed consent

Exclusion Criteria:

* dysfunctional TMD pain
* systematic diseases affecting the joints or pain perception
* pregnancy
* needle phobia

Primary outcomes:
measure: current pain measured on Numerical Rating Scale
timeFrame: 4 weeks
Secondary outcomes:
measure: maximum unassisted jaw opening in mm
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Poliklinik für Hals-Nasen-Ohrenheilkunde
Study officials:
affiliation: Department of Orthodontics, University of Heidelberg
name: Sinan Sen, Dr.med.dent.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ezzo J, Berman B, Hadhazy VA, Jadad AR, Lao L, Singh BB. Is acupuncture effective for the treatment of chronic pain? A systematic review. Pain. 2000 Jun;86(3):217-225. doi: 10.1016/S0304-3959(99)00304-8.
citation: Dworkin SF, LeResche L. Research diagnostic criteria for temporomandibular disorders: review, criteria, examinations and specifications, critique. J Craniomandib Disord. 1992 Fall;6(4):301-55. No abstract available.
Clinical trial NCT03955744: 3D Translabial Ultrasound for Pessary Size Estimation
Official title: Evaluation of 3D Translabial Ultrasound Imaging for Pessary Size Estimation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: Cosm Medical Corporation
First posted: 2019-05-20
Enrollment: 21
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a feasibility study looking at the use of 3D ultrasound with vaginal manometry at various distension volumes to predict the best available pessary for successful fit.

Detailed description: Patients who are currently using a pessary for management of pelvic organ prolapse and who are able to remove/replace the pessary themselves will be approached for recruitment. The pessary will be removed two days prior to 3D translabial ultrasound. The vagina will be distended with a pressurized compliant bag with concurrent pressure and volume measurements. Translabial ultrasound will be used to measure structural parameters within the vagina at varying pressures/volumes. The volume, pressure and structural parameters measured will be compared to dimensions of the patient's own pessary to develop mathematical models to predict the best available pessary choice for the patient.

Eligibility criteria: Inclusion Criteria:

* are current pessary users (\> 6 months) who have no pessary related complication, including discomfort, vaginal bleeding, and pessary extrusion
* are able to provide informed consent
* can perform self-care, i.e. removing and inserting the pessary themselves
* are willing to remove their pessary two days before the ultrasound examination date

Exclusion Criteria:

* inability to give informed consent
* inability to communicate with the person performing the consent and the sonographer performing ultrasound scanning
* history of pelvic radiation or surgery (excluding hysterectomy)
* using pessaries other than ring, incontinence dish, donut, Shaatz
* inability to perform the Valsalva maneuver or pelvic floor contraction
* restricted mobility that prevents them from ambulating to assess the comfort level of the pessary during the initial pessary fitting visit
* lack of sensation at the pelvic floor
* being pregnant at the time of the examination

Primary outcomes:
measure: 3D ultrasound images and pressure/volume measurements of vagina in patients with pelvic organ prolapse
timeFrame: 1 hour and 20 minutes (i.e. the estimated time for the ultrasound and manometry examination per participant).
Secondary outcomes:
measure: Survey
timeFrame: 5 minutes
Other outcomes:
Locations:
city: London
country: Canada
facility: Western University
state: Ontario
Study officials:
References:
Clinical trial NCT01423344: Clinical Evaluation of the Serum Free Light Chain Analysis
Official title: Assessment of the Value of the Free Kappa and Free Lambda Light Chain Assay in Clinical Evaluation of Response to Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma
Keywords: multiple myeloma
Free light chains
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2011-08-25
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed patients with multiple myeloma, with medical needs and known patients with multiple myeloma at there 1st relapse and medical needs

Brief summary: Background: in patients with multiple myeloma there is a raised level of a protein, named M-protein. This M-protein is normally used to monitor disease status and evaluate response to treatment, as a decrease in M-protein is taken as evidence of therapeutic efficacy. However, the M-protein has a long half life in serum, approximately three weeks, which tend to be a practical problem, since the investigators can first determine hereafter if the treatment is effective.

A new assay has the possibility only to measure part of this protein, namely "the light chains", which also is measured in a blood sample. The half life of these light chains is much shorter, namely 2-6 hours. In theory, this means a more rapid measure of the effect of a given treatment, thereby being able to determine earlier if the treatment should continue or changed to another strategy.

Purpose: the purpose of this study is to evaluate the clinical value of the use of the serum free light chain (sFLC) assay in comparison to the M-protein in monitoring patients under treatment for multiple myeloma.

Method: the investigators measure sFLC in patients receiving there 1st treatment, either at the time of diagnosis or in the relapse setting. sFLC is measured on a regular basis, and the results are compared to the M-protein.


Eligibility criteria: Inclusion Criteria:

* diagnosis of multiple myeloma
* abnormal serum free light chains
* medical needs of anti-myeloma therapy
* receiving standard anti-myeloma therapy

Exclusion Criteria:

* dialysis
* normal serum free light chains
* dementia

Primary outcomes:
measure: Time to 50% reduction in the concentration of the abnormal serum free light chain compared to 50% reduction in M-protein
timeFrame: 1, 2, 3, 4 and 5 days, 2, 3 and 6 weeks after therapy,
Secondary outcomes:
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Department of Haematology, research unit
Study officials:
affiliation: Department of Haematology, research unit
name: Charlotte T Hansen, Fellow
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02248844: Safety and Effectiveness of BOTOX® for Lateral Canthal Lines With or Without Simultaneous Glabellar Lines in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lateral Canthal Lines
Crow's Feet Lines
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-09-25
Enrollment: 667
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with Lateral Canthal Lines (Crow's Feet Lines)

Brief summary: This is a postmarketing surveillance study in Korea to evaluate the safety and effectiveness of BOTOX® for lateral canthal lines (crow's feet lines) with or without simultaneous glabellar lines.


Eligibility criteria: Inclusion Criteria:

* Subject and Investigator decision to treat crow's feet lines with Botox®

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Up to 3 months
Secondary outcomes:
measure: Investigator's Assessment of Change in Appearance of Crow's Feet Lines on a 3-Point Scale
timeFrame: Baseline, Up to 3 months
measure: Subject's Assessment of Change in Appearance of Crow's Feet Lines on a 7-Point Scale
timeFrame: Baseline, Up to 3 months
Other outcomes:
Locations:
city: Gangnam-gu
country: Korea, Republic of
facility: Dr. Robbin Clinic
state: Seoul
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01025544: Study in Toddlers (12-18 Months) Comparing a Booster Dose of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b Infections in China
Official title: A Phase III Open Label, Multi-Center Pediatric Study in China Comparing Booster Doses of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b (Hib) Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Haemophilus Influenzae Type b (Hib) Infection
Keywords: Haemophilus influenzae type b (Hib)
Vaccine
Booster
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-12-03
Enrollment: 846
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the safety and immunogenicity of booster doses of the two vaccines used to prevent Haemophilus influenzae type b infections in children 12-18 months of age.


Eligibility criteria: Inclusion Criteria:

* Toddlers 12-18 months of age who have previously participated in study M37P2.

Exclusion Criteria:

* Prior Hib booster administration.
* History of serious reaction(s) following vaccination.
* Vaccination within 14 days of study vaccination.
* Known or suspected immune impairment.
* For additional entry criteria please refer to the protocol.

Primary outcomes:
measure: Anti-PRP antibody levels at day 31 post booster
timeFrame: 31 days after vaccination
Secondary outcomes:
measure: Solicited local and systemic reactions, AEs, and SAEs
timeFrame: 30 days post vaccination
Other outcomes:
Locations:
city: Hebei Province
country: China
Study officials:
affiliation: 41 61 324 1111
name: Novartis Basel
role: STUDY_CHAIR
References:
Clinical trial NCT04552444: Clinical Efficacy of Combination Therapy Based on High-dose Biapenem in CRKP Infections
Official title: Clinical Efficacy of Combination Therapy Based on High-dose Biapenem in CRKP Infections
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: High-dose Biapenem
Keywords: High-dose Biapenem
Carbapenem resistance Klebsiella pneumoniae
Clinical Efficacy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Most of the patients were from the coastal areas of the Yangtze River, and some of them were exposed to all parts of the country.

Brief summary: Carbapenem resistance is a high mortality rate of Klebsiella pneumoniae infection. It has been proved that high-dose carbapenem can reduce mortality and has a certain clinical effect. In this study, a high dose of biapenem was compared to determine whether it had a similar effect than meropenem.


Eligibility criteria: Inclusion Criteria:

* ICU hospitalized for more than 3 days;
* Biapenem used for more than 3 days

Exclusion Criteria:

* Patients who refuse to be included in the group or pregnant women or under the age of 14 or ICU hospitalized for less than 3 days

Primary outcomes:
measure: 28-day mortality
timeFrame: 2017.01.01-2021.12.31
Secondary outcomes:
measure: Clearance rate of pathogenic microorganisms
timeFrame: 2017.01.01-2021.12.31
measure: ICU hospitalization days
timeFrame: 2017.01.01-2021.12.31
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University Medical College
state: Please Select
Study officials:
References:
Clinical trial NCT00664144: Rasburicase for the Treatment/Prevention of Hyperuricemia in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma
Official title: Study of Efficacy and Safety of Rasburicase for the Treatment/Prevention of Hyperuricemia Related to Tumor Lysis Syndrome in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma, Previously Treated or Not With Urate Oxidase Presenting With Hyperuricemia and/or Bulky Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hyperuricemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The primary objective was to evaluate the efficacy of rasburicase in terms of prevention and treatment of hyperuricemia related to Tumor Lysis Syndrome (TLS) in 2 populations of adult patients, previously treated or not with urate oxidase, with relapsing aggressive non-Hodgkin's lymphoma (NHL) and at risk of TLS, presenting with hyperuricemia and/or bulky disease at diagnostic of relapse.

The secondary objectives were to :

* evaluate the efficacy of rasburicase in terms of renal protection,
* evaluate the safety of rasburicase in the two cohorts of patients,
* correlate efficacy and safety results with antibodies generation/level.


Eligibility criteria: Patients with histologically proven aggressive Non Hodgkin's Lymphoma

Primary outcomes:
measure: responder rate (based on normalization of uric acid levels)
Secondary outcomes:
Other outcomes:
Locations:
city: Diegem
country: Belgium
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi- Aventis Administrative Office
city: Berlin
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Milan
country: Italy
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD
role: STUDY_DIRECTOR
References: