louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03650283: Relation Between PRST Score, Skin Conductance and BIS
Official title: The Relation Between PRST Score, Skin Conductance and BIS Values During Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Awakeness, Pain
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Determine the relation between PRST (pressure, rate, sweating, tears) score, skin conductance (SC) and Bispectral index (BIS) values during anesthesia

Detailed description: Probability of \>0 points in the PRST as a function of BIS and number of fluctuations in mean skin conductance (NFSC) will be recorded during the anesthesia.

Eligibility criteria: Inclusion Criteria:

* Minor elective surgery
* General anaesthesia

Exclusion Criteria:

* autonomic neuropathy
* presence of a pacemaker
* medication with anticholinergic drugs
* use of ketamine, clonidine

Primary outcomes:
measure: Correlation between NFSC, PRST and BIS
timeFrame: anesthesia induction (while giving induction agent to the patient), surgical incision (when the surgeon makes the first incision), extubation (when LMA is removed)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04107883: Effect of Transfusion of Plasma on Endothelial During Liver Transplantation
Official title: Effect of Transfusion of Plasma During Orthotopic Liver Transplantation on Endothelial Glycocalyx Layer and Short-term Outcome in Patients With End-Stage Liver Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Liver DIsease
Liver Transplantation
Keywords: endothelial
plasma
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effects of plasma transfusionon during liver transplantation on endothelial condition and short-term outcome in patients with end-stage liver disease.


Eligibility criteria: Inclusion Criteria:

* Child A/B cirrhosis
* patients who undergo the first OLT
* Informed and consented
* complete follow-up
* cooperate with treatment

Exclusion Criteria:

* re-transplant
* combined liver and other organ transplantation
* BMI≥30Kg/m2
* patients with hypertension, diabetes, coronary heart disease, chronic renal insufficiency, preoperative pulmonary infection, pleural effusion
* acute liver failure

Primary outcomes:
measure: endothelial glycocalyx layer shedding markers
timeFrame: 24 hours
Secondary outcomes:
measure: inflammatory cytokines
timeFrame: 24 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical University Affiliated Beijing Chaoyang Hospital
state: Beijing
Study officials:
affiliation: Capital Medical University Affiliated Beijing Chaoyang Hospital
name: Anshi Wu
role: STUDY_CHAIR
References:
Clinical trial NCT01835483: Determination of Performance Characteristics of the MassPLEX Factor II/V Leiden Test
Official title: A Multicenter Clinical Study to Determine the Performance Characteristics of the MassPLEX Factor II and Factor V Leiden Genotyping Test in Patients With Suspected Thrombophilia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Factor V Leiden
Factor II
Thrombosis
Lead sponsor: Sequenom, Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-19
Enrollment: 867
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with suspected thrombophilia

Brief summary: To establish the overall agreement of the MassPLEX Factor II and Factor V Leiden Genotyping Test with bi-directional DNA sequencing for Factor II and Factor V Leiden.

Detailed description: De-identified banked genomic DNA samples derived from whole blood from subjects with suspected thrombophilia will be collected from one or more clinical sites. Three clinical laboratory sites will analyze the samples with the FII/FVL Test. Bi-directional DNA sequencing will be performed on all samples at an independent core reference laboratory.

Eligibility criteria: Inclusion Criteria:

* suspected thrombophilia
* 18 years of age or older

Exclusion Criteria:

* none

Primary outcomes:
measure: Performance of the MassPLEX Factor II/V Leiden Test
timeFrame: Samples are collected at time of suspected thrombotic event.
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Sequenom Center for Molecular Medicine
state: Michigan
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Houston
country: United States
facility: The Methodist Hospital Research Institute
state: Texas
Study officials:
References:
Clinical trial NCT01514383: Octylseal Surgical Adhesive in General Surgery
Official title: Evaluation of Octylseal as a Topical Surgical Skin Incision Adhesive in General Surgery: A Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wounds
Keywords: wounds
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2012-01-23
Enrollment: 34
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate how surgical adhesive is used.

Detailed description: In this Case Series Study, clinician experience and subject outcomes will be recorded in the use of a topical skin adhesive (Octylseal) on the closure of skin incisions from General surgical procedures.

Eligibility criteria: Inclusion Criteria:

* Candidate for use of a topical surgical skin adhesive

Exclusion Criteria:

* Subjects with know sensitivity to topical surgical tissue adhesive products or degrading products (cyanoacrylates or formaldehyde)
* Subjects with a history of keloid formation, hypotension, insulin dependent diabetes mellitus, blood/clotting disorders, peripheral vascular diseases or hypertrophy history
* Subjects who present with a contraindications for product usage as per labeling
* A wound with evidence of active infection or gangrene or wounds of decubitus etiology
* Mucosal surfaces or across mucocutaneous junctions or skin that might be exposed to bodily fluids or with dense natural hair
* Subjects with known hypersensitivity to cyanoacrylate or formaldehyde

Primary outcomes:
measure: Wound Length Closure
timeFrame: During Surgery
Secondary outcomes:
measure: Number of Participants With a Score of "0" (No Hurt) on the Pain Rating Scale
timeFrame: At Surgery
Other outcomes:
Locations:
city: Jersey City
country: United States
facility: Jersey City Medical Center
state: New Jersey
city: New York
country: United States
facility: Wyckoff Hospital
state: New York
Study officials:
affiliation: Medline Industries
name: Ed Drower, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT01167283: Effect of Electrostimulation in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Effect of Electromyostimulation in Severe Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Centre Hospitalier Régional Universitaire Montpellier
First posted: 2010-07-22
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study was designed to test the following hypothesis:

To investigate whether COPD muscles can respond to stimuli in terms of changes in fiber-type distribution.

Detailed description: Background: Muscle dysfunction is a major problem in chronic obstructive pulmonary disease (COPD). It is characterized by muscle fiber-type redistribution and oxidative stress. Classical training does not improve these features.

Objectives: To investigate whether electrostimulation program following exacerbation can modify muscle structure and function in COPD patients.

Method: We propose to conduct a controlled and randomized clinical trial comparing the efficacy of muscle electrostimulation training of the lower limbs to sham training in 15 patients with COPD. Patients are included in either 6 weeks of electrostimulation training (active treatment group) or 6 weeks of sham electrostimulation. Primary outcomes were changes in muscle structure, muscle oxidative stress and their relationship with quadriceps force and exercise tolerance.

Eligibility criteria: Inclusion Criteria:

* COPD patients during or after exacerbation

Exclusion Criteria:

* Comorbidities that could limit exercise training
* Obesity (body mass index \[BMI\] \> 30 kg/m²)
* Neuromuscular disease
* Pacemaker implantation

Primary outcomes:
measure: Fiber-type distribution
timeFrame: 6 to 8 weeks
Secondary outcomes:
measure: Change in the strength of the quadriceps over the 6-week electrostimulation program
timeFrame: 6 to 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Olivier OJ Jonquet, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06259383: Oral Ivermectin for Chikungunya Viral Infection
Official title: A Randomized Controlled Trial of Oral Ivermectin for Patients With Chikungunya Viral Infection During Urban Outbreak in Southern Thailand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Clinical Syndrome
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chikungunya viral infection (CVI) is a mosquito-borne infection, caused by chikungunya virus (CHIKV), an alphavirus, belonging to the family Togaviridae. This infection causes febrile illness associated with high fever, rash, acute deliberating and persistent arthralgia. There is no licensed vaccine or specific treatment for this infection. Ivermectin (IVM), commonly-used antiparasitic, has been demonstrated to inhibit replication of CHIKV.


Eligibility criteria: Inclusion Criteria:

* patients with virologic confirmation of chikungunya infection who had symptoms less than 72 hours prior to visit

Exclusion Criteria:

* patients with virologic confirmation of chikungunya infection who had symptoms more than 72 hours prior to visit

Primary outcomes:
measure: Day of fever clearance
timeFrame: 1 week
Secondary outcomes:
measure: Day of virologic clearance
timeFrame: 1 week
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Prince of Songkla University
state: Songkhla
Study officials:
References:
Clinical trial NCT04740983: Ultraviolet Radiation Forecasting Based Heliotherapy For Psoriasis in Bangkok, Thailand
Official title: The Study of Efficacy and Safety of UV Forecasting Based Heliotherapy For Psoriasis in Bangkok, Thailand: A Split-side Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psoriasis Vulgaris
Keywords: Heliotherapy
sun-bathing
psoriasis
ultraviolet radiation
forecasting
Thailand
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: King Chulalongkorn Memorial Hospital
First posted: 2021-02-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Due to limited number of phototherapy centres and shortage of qualified phototherapy practitioners, heliotherapy has become a promising treatment alternative in Thailand where patients effortlessly receive supervised sun-bathing treatments from their homes whenever they are convenient. We used newly designed deep neural network UV forecasting model developed by using our 10 year-retrospective Solar UV irradiance (280-400 nm) retrieved from a ground based platform at Atmosperic laboratory, Silpakorn University, Nakhon Pathom, Thailand (13.82N 100.04E, 30 m above mean sea level). This model achieved a next-day forecast error of less than 12% which has been the most accurate prediction to date. We designed our 10week heliotherapy regimen based on the predicted anti psoriasis effective irradiance values. We studied efficacy and safety of the 12-week heliotherapy regimen for psoriasis on only ruled acceptable clear sky days in Bangkok, Thailand

Detailed description: We studied efficacy and safety of the 16-week heliotherapy regimen for psoriasis on only ruled acceptable clear sky days in Bangkok, Thailand

Eligibility criteria: Inclusion Criteria:

* A psoriasis patient who indicate to have phototherapy and have lesional plagues systemically either on the front-back or left-right.
* A participant is based in Bangkok
* A participant is capable to understand and learn how to use our in-house assembled UV metre and web-based heliotherapy platform.

Exclusion Criteria:

* A participant has any sun-sensitive conditions including photo-aggravated photodermatoses and on photosentisitive drug treatments.
* Breast-feeding, pregnant individuals.

Primary outcomes:
measure: Changes of Targeted PASI score
timeFrame: 16 weeks
Secondary outcomes:
measure: Incidence of possible acute side effects after sun bathing
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04441983: Foot/Ankle At 7T MRI
Official title: High-Resolution MRI (7 Tesla) Findings of the Plantar Plate Compared with Current Clinical Standard Sequences (1.5 or 3 Tesla) and Surgical Reference Standard
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Plantar Plate Tear
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have undergone a forefoot MRI for clinical indications (or previous study) will be enrolled

Brief summary: * To evaluate standard clinical sequences for 7 Tesla MRI of the foot and/or ankle to improve detailed depiction of the complex anatomy of this region.
* To evaluate various pathologies of the foot and/or ankle (plantar plate tears, Morton neuroma, tendon tears, ligament tears etc.).


Eligibility criteria: Inclusion Criteria:

* Informed consent as documented by signature (Appendix Informed Consent Form)
* at least 18 years old
* Study group: Patients with specific pathologies (i.e. Morton neuroma, tendon tears, plantar plate tears) as proven by 1,5 or 3T MRI or asymptomatic subjects (to look at the normal microanatomy of different structures, mainly the plantar plate)
* Control group: No evidence of the respective pathology.

Exclusion Criteria:

* previous foot surgery with metal in vivo
* pregnancy or breast feeding
* any MRI contra-indications

Primary outcomes:
measure: sensitivity / specificity
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: Balgrist University Hospital
name: Reto Sutter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05988983: The Over The Counter Pill National Study
Official title: The Over The Counter Pill National Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Contraception
Contraception Behavior
Contraceptive Usage
Health Care Utilization
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Arnold Ventures
First posted: 2023-08-14
Enrollment: 1026
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 51
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals aged 12 to 51 who are obtaining the oral contraceptive pill at a pharmacy for the purposes of pregnancy prevention.

Brief summary: This is a prospective cohort study of individuals purchasing the oral contraceptive pill over the counter (OTC) in pharmacies in 32 US states. The comparison group is people receiving a prescription (Rx) for oral contraception. Both groups will be followed for one year to examine contraceptive continuation rates. This study will also identify who is using the pill OTC and why and evaluate differences in pregnancy intention and measures of contraceptive agency between the two groups.


Eligibility criteria: Inclusion Criteria:

* Capable of pregnancy
* Purchasing oral contraception at a participating pharmacy

Exclusion Criteria:

* Using the pill for non contraceptive indications

Primary outcomes:
measure: 12 month contraceptive continuation rates
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
Clinical trial NCT02211183: InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear
Official title: A Randomized, Two-arm, Prospective, Subject Blind Study to Assess the Safety and Efficacy of InSpace™ Device in Comparison to Full Thickness Massive Rotator Cuff Repair in Subjects Scheduled for a Repair Surgery.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: Massive Rotator Cuff Tear
Sub-acromial spacer
Best repair of rotator cuff
Lead sponsor: OrthoSpace Ltd.
Sponsor class: INDUSTRY
First posted: 2014-08-07
Enrollment: 4
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .

Detailed description: The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily living (ADL) and improvement of range of motion (ROM).

Eligibility criteria: Main Inclusion Criteria:

* Age 40 or older.
* Positive diagnostic imaging of the affected shoulder indicating full thickness Massive RCT (according to Cofield classification) or long involving more than one tendon.
* Persistent pain and functional disability of the affected shoulder for at least 3 months.

Main Exclusion Criteria :

* Known allergy to the balloon material (copolymer of PLA and -θ-caprolactone).
* Evidence of significant osteoarthritis or cartilage damage in the shoulder
* Evidence of gleno-humeral instability
* Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy
* Evidence of major joint trauma, infection, or necrosis in the shoulder
* Partial-thickness tears of the rotator cuff

Primary outcomes:
measure: The change in Shoulder Score from baseline
timeFrame: baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
Study officials:
affiliation: Head of Shoulder and Elbow Reconstructive Surgery Unit, Department of Orthopedic Surgery and Traumatology
name: Emilio Calvo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00759083: Bivalirudin PCI Registry in Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome (HIT/HITTS) Patients
Official title: Bivalirudin PCI Registry in HIT/HITTS Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Heparin-Induced Thrombocytopenia
Heparin-induced Thrombocytopenia and Thrombosis Syndrome
Keywords: HIT
HITTS
Lead sponsor: The Medicines Company
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To monitor the frequency of the development of thrombocytopenia in patients with Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome receiving bivalirudin during Percutaneous Coronary Intervention


Eligibility criteria: Inclusion Criteria:

* Clinically Documented History of HIT/HITTS
* Suspicion of HIT/HITTS

Exclusion Criteria:

* Bleeding Diathesis
* Ischemic Stroke
* Chronic Thrombocytopenia
* Hematologic Malignancy
* Contraindication to bivalirudin
* Pregnant or nursing mothers

Primary outcomes:
measure: Platelet counts
timeFrame: 6, 12, 24, 48 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Clinical Research Institute
state: North Carolina
Study officials:
affiliation: Duke Clinical Research Institute
name: Magnus Ohman, MD
role: PRINCIPAL_INVESTIGATOR
References: