louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05723419: Prediction of Clinical Outcome in Axillary Block
Official title: Perfusion Index Value in Predicting the Clinical Outcome of Axillary Block
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain, Chronic
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who visit the pain clinic

Brief summary: The primary endpoint of this study was to identify that Perfusion index (PI) has any predictive value for the treatment outcome of cervical radiculopathy

Detailed description: The interscalene brachial plexus block is an effective intervention for reducing postoperative pain but is related to side effects, Suprascapular nerve block and a block of the axillary nerve have been introduced as alternatives to the interscalene brachial plexus for the control of postoperative pain. Previous study demonstrated new method of axillary block using interfascial plane injection guided by ultrasoud. Axillary block has been used widely for the relief of postoperative arm pain.

Recent study deomonstrated good pain relief when ultrasound guided fascial plane injection was performed in patients with cervical radiuculopathy.

The perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter. Although the special probe for PI measurement is relatively more expensive compared with ordinary pulse oximetery probes, its benefit as a marker of peripheral perfusion and as an idex for sympathetic stimulation have increased its use progressively. PI has been used widely for the prediction of success of brachial plexus block or axillary block. Changes of PI ratio value showed an excellent predictive value for the success of block.

There have been no studies demonstrating any predictive value of PI in axillary block for the relief of cervical radiulopathy

Eligibility criteria: Inclusion Criteria:

* Cervical foraminal stenosis
* Cervical central stenosis
* Cervical disc herniation
* Cervical spondylolisthesis

Exclusion Criteria:

* Infection
* pregnancy
* allergy to local anesthetic agents
* previous cervical spine surgery

Primary outcomes:
measure: Perfusion index changes among 4 time periods
timeFrame: baseline, 10 minutes, 20 minutes, 30 minutes after axillary block
measure: Number of patients showing numerical rating scale reduction more than 50%
timeFrame: 1 month after axillary block
measure: Number of patients showing numerical rating scale reduction less than 50%
timeFrame: 1 month after axillary block
measure: Number of patients showing no reduction in numerical rating scale
timeFrame: 1 month after axillary block
measure: Neck disability index changes between 2 time periods
timeFrame: baseline, 1 month after axillary block
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Ji Hoon Park
Study officials:
References:
Clinical trial NCT04262219: Clinician Communication About Sexual Health
Official title: Enhancing Clinician Communication About Sexual Health in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-02-10
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to adapt a previously tested brief intervention aimed at enhancing clinicians communication about sexual health (iSHARE) to a mobile web-based platform showcasing a two-part podcast and to assess the feasibility, acceptability, and preliminary effects of the intervention in breast cancer clinicians.

Detailed description: Specific aims are: 1) To assess the feasibility and acceptability of iSHARE in a mobile learning (mLearning) format and 2) To assess the preliminary effects of iSHARE in a mLearning format.

Eligibility criteria: Inclusion Criteria:

* Clinician is a medical oncologist or medical oncology advanced practice clinician (Nurse Practitioner, Physician Assistant) who treats breast cancer patients

Exclusion Criteria:

* Clinician has participated in previous pilot study of the intervention

Primary outcomes:
measure: Feasibility of the Intervention Trial - Enrollment
timeFrame: Baseline
measure: Feasibility of the Intervention Trial - Retention
timeFrame: Baseline up to 1 month
measure: Feasibility of the Intervention Trial - Intervention Completion
timeFrame: 1 month
measure: Acceptability
timeFrame: 1 week up to 1 month
measure: Change in Clinician Knowledge About Sexual Health and Related Communication
timeFrame: Baseline up to 1 month
measure: Change in Clinician Self-Efficacy About Sexual Health Communication
timeFrame: Baseline up to 1 month
measure: Change in Clinician Outcome Expectancies for Sexual Health Communication
timeFrame: Baseline up to 1 month
measure: Change in Clinician Comfort With Communicating About Sexual Health
timeFrame: Baseline up to 1 month
measure: Change in Clinician Communication About Sexual Health
timeFrame: Baseline up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Jennifer B Reese, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03707119: Student 4 Best Evidence as a Tool to Improve Evidence-Based Practice Competencies
Official title: The Effectiveness of Student 4 Best Evidence as a Tool to Improve Evidence-Based Practice Competencies in Undergraduate Health Professional Students: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Undergraduate Health Professional Students
Keywords: educational programme; EBP competencies; training;
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 70 undergraduate physiotherapist students of the first year, of both genders, were included. Mean age was 20.48+/-3.20 years, 66% male.

Brief summary: Objective. The aim of the study was to evaluate the effectiveness of an educational program, based on Students 4 Best Evidence (S4BE) Blog, on Evidence-Based Practice (EBP) competencies (attitudes, knowledge and skills) through an EBP laboratory, in undergraduate students of Physiotherapy.

Design. An observational perspective study. Setting. Physiotherapy School of Italian University. Participants. 70 undergraduate physiotherapist students of the first year, of both genders, were included. Mean age was 20.48+/-3.20 years and 66% were male and 34% were female.

Interventions. The intervention consisted of the use of S4BE to teach EBP competence. The section S4BE "about" has been used to teach the EBP principles and their key steps and the section S4BE "topics" has been used to teach critical thinking and the clinical practice in rehabilitation for a total of 24 training hours.

Main Outcome Measure. The evidence-based practice questionnaire (EBP2Q) has been used to evaluate EBP attitude, knowledge and skills, at the start of laboratory (T0), after 24 training hours (T1) and after 3 months of clinical practice training (follow-up). Statistical analysis was performed with SPSS 17.0 An intra-group analysis has been conducted to verify the improvement during the time. Statistically significant was set at p\<0.05.


Eligibility criteria: Inclusion Criteria:

* undergraduate physiotherapist students of the first year
* both genders

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Evidence-based practice questionnaire (EBP2Q)
timeFrame: Change from baseline EBP competencies at 24 training hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rovato
country: Italy
facility: Centro "E. Spalenza" - Fondazione Don Carlo Gnocchi
state: Brescia
Study officials:
affiliation: Fondazione Don Carlo Gnocchi
name: Chiara Arienti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arienti C, Lazzarini SG, Pollet J, Negrini S. Students 4 Best Evidence as a digital Problem-Based Learning method to improve Evidence-Based Practice competencies in undergraduate physiotherapy students: an observational study. BMJ Evid Based Med. 2021 Oct;26(5):251-252. doi: 10.1136/bmjebm-2020-111395. Epub 2020 Oct 21.
Clinical trial NCT04559919: Prospective Regional Epilepsy Database
Official title: Prospective Regional Epilepsy Database and Biobank for Individualized Clinical Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy
Keywords: epilepsy
biomarker
access to care
quality of care
seizure
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 1000
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: Adults with an unprovoked seizure or epilepsy, resident in VGR at inclusion.

Brief summary: PREDICT is an observational study following adults with an unprovoked seizure or epilepsy in the health care region of western Sweden. The objective is to identify biomarkers and/or genetic predisposition of relevance for diagnosis and/or treatment of epilepsy and study the long-term prognosis and consequences of epilepsy.

Detailed description: Adults over 18 years of age, with an unprovoked seizure in the last year or epilepsy, resident in the health care region of western Sweden (VGR) at the time of inclusion.

Baseline data and outcome variables are collected from several patient registries: the electronic medical records system in the health care region VGR and Swedish National Registers of healthcare, income, and employment managed by The National Board of Health and Welfare or Statistics Sweden, both of which are government agencies.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* An unprovoked seizure within the last year or a diagnosis of epilepsy according to the current International League Against Epilepsy definition (epilepsy with seizure in the last ten or antiepileptic drug treatment in the last five years)

Exclusion Criteria:

* Expected survival less than two years
* Inability to give informed consent

Primary outcomes:
measure: epilepsy
timeFrame: baseline and years 1,2,3,4,5,6,7,8,9,10
measure: seizure status
timeFrame: baseline and years 1,2,3,4,5,6,7,8,9,10
measure: drug resistant epilepsy
timeFrame: baseline and years 1,2,3,4,5,6,7,8,9,10
measure: severe side effects of antiepileptic drug
timeFrame: baseline and years 1,2,3,4,5,6,7,8,9,10
measure: psychosocial outcomes
timeFrame: baseline and years 1,2,3,4,5,6,7,8,9,10
Secondary outcomes:
measure: received health care
timeFrame: baseline and years 1,2,3,4,5,6,7,8,9,10
Other outcomes:
Locations:
city: Borås
country: Sweden
facility: Södra Älvsborgs Sjukhus
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Gothenburg
country: Sweden
facility: Sjukhusen i Väster
Study officials:
affiliation: Sahlgrenska University Hospital
name: Johan Zelano, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05806619: Glioma: Biomolecular Aspects
Official title: Glioma: BIOMOLECULAR Aspects From Tissue to Radiomics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioma, Malignant
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected glioma who have been subjected to surgery at diagnosis or recurrence

Brief summary: Main limitations in Glioma studies are due to the wide heterogeneity and genetic instability of the tumor and to the fact that the molecular informations are static, i.e. obtained on the tumor at its onset. Instead, spontaneous or therapy-induced variations are difficult to evaluate and they would need further sampling of the tumor throughout the clinical history. Currently these data are more and more routinely used not only for diagnostics but also in the clinical management of the patient.

Furthermore, microenvironment study is becoming increasingly important. It is also important correlate morpho-functional pathway and brain Magnetic Resonance.

Therefore, the main goal of the study is to correlate the data obtained with morphological (site, signal intensity, margins, behavior after contrast medium infusion, mismatch between T2 and FLAIR sequences) and non-morphological MR imaging through a radiomic approach and Diffusion and Perfusion study, with molecular data relating to the IDH mutation, MGMT gene promoter methylation, 1p/19q co-deletion and EGFRvIII expression.

Furthermore, it is proposed to carry out a correlation between the radiological data and the mutations found in the NGS panel.


Eligibility criteria: Inclusion Criteria:

* glioma diagnosis
* have performed morphological brain MRI or not with contrast medium before surgery
* informed consent form

Exclusion Criteria:

* Patients without Magnetic Resonance were excluded

Primary outcomes:
measure: Correlation between MR and molecular data
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rom
country: Italy
facility: San Giovanni Addolorata Hospital
state: Roma
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
References:
Clinical trial NCT01862419: An Electronic Alert System for In-Hospital Acute Kidney Injury
Official title: An Electronic Alert System for In-Hospital Acute Kidney Injury: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 2393
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: This study will randomize hospitalized patients with acute kidney injury (AKI) to usual care, or an electronic alert intervention. The electronic alert will be in the form of a text page that will be sent to the covering clinician and unit pharmacist once per patient with AKI at the time lab results are uploaded. The investigators hypothesize that such an alert will improve outcomes in these patients.


Eligibility criteria: Inclusion Criteria:

* Adults \>=18 years
* Admitted to the Hospital of the University of Pennsylvania for greater than 24 hours.

Exclusion Criteria:

* Dialysis order within 24 hours of admission
* Dialysis order prior to AKI onset
* Initial creatinine \>=4.0mg/dl
* Prior admission in which patient was randomized.
* Nephrectomy during the admission
* Admission to hospice service
* Admission to observation status

Primary outcomes:
measure: Dialysis Within 7 Days
timeFrame: From start of AKI to 7 days later
measure: Death
timeFrame: 7 days of randomization
measure: Relative Maximum Change in Creatinine
timeFrame: 7 days of randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Phiadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Barry Fuchs, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Francis P Wilson, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilson FP, Shashaty M, Testani J, Aqeel I, Borovskiy Y, Ellenberg SS, Feldman HI, Fernandez H, Gitelman Y, Lin J, Negoianu D, Parikh CR, Reese PP, Urbani R, Fuchs B. Automated, electronic alerts for acute kidney injury: a single-blind, parallel-group, randomised controlled trial. Lancet. 2015 May 16;385(9981):1966-74. doi: 10.1016/S0140-6736(15)60266-5. Epub 2015 Feb 26.
citation: Wilson FP, Reese PP, Shashaty MG, Ellenberg SS, Gitelman Y, Bansal AD, Urbani R, Feldman HI, Fuchs B. A trial of in-hospital, electronic alerts for acute kidney injury: design and rationale. Clin Trials. 2014 Oct;11(5):521-9. doi: 10.1177/1740774514542619. Epub 2014 Jul 14.
Clinical trial NCT02396719: A Real-World Registry to Investigate the Performance of LenSx® Laser in Chinese Patients
Official title: A Prospective, Single-Arm, Multicenter, Registry Study to Investigate the Performance of Femtosecond Laser-Assisted Cataract Surgery in Chinese Cataract Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataracts
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-03-24
Enrollment: 1541
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese patients who undergo cataract surgery using LenSx® Laser and phacoemulsification in at least one eye will be eligible to participate.

Brief summary: The purpose of this study is to investigate the performance of LenSx® Laser in femtosecond laser-assisted cataract surgery (FLACS) in real-world medical practice in Chinese patients.

Detailed description: All subjects will undergo FLACS using the LenSx® Laser system. The recommended postoperative visits will follow the current standard of care in China.

Eligibility criteria: Inclusion Criteria:

* Chinese;
* Will undergo LenSx® Laser-assisted cataract surgery and phacoemulsification in at least one eye;
* Must sign written informed consent;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Contraindications listed in LenSx® Laser System Operator's Manual;
* Pregnant, nursing, or planning a pregnancy;
* Concurrent enrollment in another investigational drug and/or device study or participation in such a study within 30 days prior to surgery day;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Completion rate of a round anterior capsulotomy
timeFrame: Surgery (Day 0)
Secondary outcomes:
measure: Completion rate of lens fragmentation without additional segmentation after LenSx Laser procedure
timeFrame: Surgery (Day 0)
measure: Completion rate of intraocular lens (IOL) implantation
timeFrame: Surgery (Day 0)
measure: Completion rate of corneal incisions
timeFrame: Surgery (Day 0)
measure: Best-corrected distance visual acuity (BCDVA)
timeFrame: Up to Day 30
measure: Percentage of patients with BCDVA of 20/20, 20/25, 20/40 or better at each visit
timeFrame: Up to Day 30
Other outcomes:
Locations:
city: Beijing
country: China
facility: Alcon China Ophthalmic Product Co., Ltd.
Study officials:
affiliation: Alcon China
name: Zuojun Gao, Medical Affairs Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02707419: Action Observation in Knee Replacement
Official title: Self-administered Action Observation Treatment Enhance the Efficacy of Inpatient Rehabilitation After Total Knee Replacement: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Replacement
Keywords: Total knee replacement
Action observation treatment
Rehabilitation
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative rehabilitation is required for a successful outcome following total knee arthroplasty. Traditionally rehabilitative programs aim to increase range of motion, to strengthen quadriceps, to restore normal gait, and to recover independence in activities of daily living. In the last decade action observation treatment, in addition to conventional physiotherapy has been proposed as a treatment method in rehabilitative medicine. There is growing evidence of the applicability of action observation training in rehabilitative medicine, indeed it has been applied in the rehabilitation of stroke of Parkinson disease of cerebral palsy and of aphasia.

Nevertheless those are small studies and one of them included a mixed population of hip and knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Primary total knee replacement.

Exclusion Criteria:

* bilateral knee replacement
* previous total knee replacement.
* pre-existing motor impairment (i.e. hemiparesis, poliomyelitis, lumbar sciatica);

Primary outcomes:
measure: Change of Pain intensity
timeFrame: Baseline and immediately post-intervention
measure: Change of Range Of Motion
timeFrame: Baseline and immediately post-intervention
Secondary outcomes:
measure: Barthel index
timeFrame: Baseline and immediately post-intervention
measure: Short Form-36 motor
timeFrame: Baseline and immediately post-intervention
measure: Tinetti scale
timeFrame: Baseline and immediately post-intervention
measure: Lequesne index
timeFrame: Baseline and immediately post-intervention
Other outcomes:
Locations:
city: Piossasco
country: Italy
facility: Jorge Hugo Villafañe
state: Turin
Study officials:
References:
Clinical trial NCT00366119: Safety and Efficacy of Ramipril in the Treatment of Essential Hypertension
Official title: Phase 4 Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Ramiprin Tab. in Essential Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Essential Hypertension
Keywords: hypertension
ramipril
blood pressure
artery stiffness
BNP
CRP
Lead sponsor: Pacific Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-08-18
Enrollment: 86
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 assess which drug is more effective of Ramiprin®(ramipril) and Tritace®(ramipril) in the Treatment of Essential Hypertension


Eligibility criteria: Inclusion Criteria:

* mild and moderate essential hypertension (90mmHg≤DBP≤110mmHg)

Exclusion Criteria:

* 180mmHg≤SBP
* If differences greater than 20mmHg for SBP and 10mmHg for DBP between both arms are present on 3 consecutive readings
* If differences greater than 20mmHg for SBP and 10mmHg for DBP are present on 3 consecutive readings
* impaired hepatic function
* imapaired renal function
* angioedema
* aortic valvular stenosis or obstrcutive ejection disorder
* primary hyperaldosteronism
* renal transplantation, bilateral renal artery stenosis or unilateral stenosis in a single kidney, hemodialysis
* severe respiratory disease
* congestive heart failure( New York Association functional class Ⅲ or Ⅳ)
* malignant hypertension
* labile angina pectoris or myocardial infarction in the last 3 months before study entry

Primary outcomes:
measure: Reduction of DBP(diastolic blood pressure)
Secondary outcomes:
measure: Reduction of SBP(systolic blood pressure)
measure: Percentage of patients with Dcrease of BP(blood pressure)
measure: Percentage of patients with a Normalization of BP(blood pressure)
measure: Artery stiffness(chang of pulse wave velocity)
measure: Left ventricular diastolic function
measure: Change of BNP
measure: Change of CRP
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: 28 Yeongeon-dong, Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: HyoSoo Kim, Ph.D in MD
role: PRINCIPAL_INVESTIGATOR
References: