louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02952547: Safety and Pharmacokinetics Study of DWC20155 and DWC20156 in Healthy Subjects
Official title: A Randomized, Open-label, Oral Dose, Crossover Study to Compare the Safety and Pharmacokinetics Between Co-administration and Fixed Dose Combination of DWC20155 and DWC20156 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2016-11-02
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study to Compare the safety and pharmacokinetics between co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects


Eligibility criteria: Inclusion Criteria:

* BMI ≥ 18.5 and ≤ 27.0 kg/m2.
* No clinically significant findings
* Age 19-55 years at screening

Exclusion Criteria:

* Who has allergy to investigational product

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: 0-24 hours
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 0-24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Busan Paik Hospital
Study officials:
References:
Clinical trial NCT05018377: Effectiveness and Safety of Percutaneous Adhesiolysis Using Rac'z Catheter Versus Navi Catheter in Management of Failed Back Surgery Syndrome
Official title: Effectiveness and Safety of Percutaneous Adhesiolysis Using Rac'z Catheter Versus Navi Catheter in Management of Failed Back Surgery Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failed Back Surgery Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 60
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: In the past decade, spine surgery rates have dramatically increased in parallel to those of other procedural interventions. Persistent pain is a common occurrence after spine surgery, with the most commonly quoted prevalence rates ranging from 10% to 40%. This pain can be classified into failure to alleviate baseline pain, pain resulting from complications (e.g., arachnoiditis and epidural adhesions), and pain that ensues several years later as a sequele to alterations in spinal architecture and biomechanics (e.g., adjacent segment discogenic or facetogenic pain) which is called failed back surgery syndrome ( FBSS )

Detailed description: By observing adhesions directly, the lysis of scar tissue can be carried out mechanically using some percutaneous techniques as insertion of catheters as Rac'z catheter (thin in calibre) which will be inserted through the skin under fluoroscopy guidance or using NAVI catheter (large in calibre) either fluoroscopy guided or using thin epiduroscopy. Adhesions can be disintegrated and their evaluation scores may improve.

Eligibility criteria: Inclusion Criteria:

* Patients with history of lumbar surgery of at least 6 months duration in the past.
* Patients over the 18 years of age.
* History of persistent function-limiting lower extremity pain aggravated by "dural tug" (observed when the patient, sitting on the exam table with legs stretched out, bends forward, bringing on the back pain) with or without low back pain of at least 6 months duration after failure of conventional conservative management in most patients including NSAIDS, muscle relaxants (tizanidine, magnesium sulphate) and pregabalin.
* Patients who are competent to understand the study protocol and provide voluntary, written informed consent and participate in outcome measurements.

Exclusion Criteria:

* Unstable or heavy opioid use.
* Uncontrolled psychiatric disorders.
* Uncontrolled medical illness.
* Any conditions that could interfere with the interpretation of the outcome assessments.
* Pregnant or lactating women.
* Patients with a history or potential for adverse reaction(s) to local anaesthetics or steroid.

Primary outcomes:
measure: numerical rating scale
timeFrame: 12 months
Secondary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: 12 month
measure: pregabalin consumption
timeFrame: 12 month
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Saeid Metwaly Elsawy
Study officials:
References:
Clinical trial NCT02367677: Digital Photographs to Evaluate Blepharoptosis
Official title: Comparison Between Clinical Measurements and Computer-based Measurements on Digital Photographs to Evaluate Blepharoptosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blepharoptosis
Keywords: Photo
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2015-02-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ptosis of all causes

Brief summary: To compare measurements made by a computer software (ImageJ) made on photographs to the traditional clinical measures with a ruler in the evaluation of blepharoptosis


Eligibility criteria: Inclusion Criteria:

* Patients 18 years old or older
* Patients presenting for evaluation of blepharoptosis of any kind except the one mentioned in the exclusion criteria

Exclusion Criteria:

* Myasthenia gravis
* Thyroid eye disease

Primary outcomes:
measure: Reliability of measurements made on photographs to evaluate blepharoptosis
timeFrame: Same day
measure: Reliability of measurements made on photographs taken by smartphone to evaluate blepharoptosis
timeFrame: Same day
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre Universitaire d'Ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
state: Quebec
Study officials:
affiliation: Centre de recherche du CHU de Québec : Université Laval
name: Yvonne Molgat, MDCM, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02404077: Use of Clonidine to Prevent Withdrawal Following Prolonged Dexmedetomidine Infusions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sedation
Keywords: Patients
undergoing
ICU
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 712
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients who have been on prolonged dexmedetomidine infusions.

Brief summary: The investigators' clinical practice makes use of oral clonidine as a means of transitioning from intravenous dexmedetomidine following prolonged infusions (more than 3-5 days). Although this is common clinical practice, there is limited clinical data to demonstrate the efficacy of this technique and to provide clonidine dosing guidelines. The purpose of this study is to retrospectively review the investigators' experience with the use of oral clonidine to prevent withdrawal following the prolonged administration of dexmedetomidine.


Eligibility criteria: Inclusion Criteria:

* Patients who received clonidine during the transition from dexmedetomidine.

Exclusion Criteria:

* None

Primary outcomes:
measure: Evidence of withdrawal
timeFrame: Twice a day from the first day of taper of dexmedetomidine until 72 hrs. after the last dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Nationwide Children's Hospital
name: Joseph D Tobias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00890877: OC000459 Dose Finding Study in Patients With Mild to Moderate Persistent Asthma
Official title: Dose Finding Study in Patients With Mild to Moderate Persistent Asthma: A Parallel Group, Randomised, Placebo Controlled, Double Blind Assessment of Oral Oc000459 Dosed At Three Dose Schedules for Twelve Weeks Finding Study In Patients With Mild To Moderate Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mild to Moderate Persistent Asthma
Keywords: asthma
treatment
placebo
efficacy
safety
Lead sponsor: Oxagen Ltd
Sponsor class: INDUSTRY
First posted: 2009-04-30
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a double blind, randomised, 4 arm, parallel group, placebo controlled study of three dose levels of OC000459 tablets in patients with asthma controlled by beta agonist drugs alone. This study will compare the patients on OC000459 at three different dose levels (25mg once daily, 100mg twice daily and 200mg once daily) with patients on placebo after dosing for 17 weeks. The trial will be undertaken in an outpatient population. Each treatment arm will consist of at least 110 subjects. The objective is to assess the efficacy of these dose levels on the patients asthma.


Eligibility criteria: Inclusion Criteria:

* Male or female asthmatics, any racial group. Females of childbearing potential must practise two forms of contraception
* Aged 18 to 55 years inclusive.
* Non smokers for at least the past 12 months with a pack history of less than 10 pack years.
* Mild to moderate persistent asthma according to GINA4 guidelines for at least 12 months

Exclusion criteria:

* Receipt of prescribed or over the counter medication within 14 days prior to the first study day

Primary outcomes:
measure: Forced expiratory volume in one second (FEV1)
timeFrame: 17 weeks
Secondary outcomes:
measure: Asthma quality of life questionnaire (AQLQ)
timeFrame: 17 weeks
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Research site
city: Gyor
country: Hungary
facility: Research site
city: Warsaw
country: Poland
facility: Research site
city: Bucharest
country: Romania
facility: Research site
city: Moscow
country: Russian Federation
facility: Research site
city: Kiev
country: Ukraine
facility: Research site
Study officials:
References:
Clinical trial NCT01655277: Ultrasound Guided Adductor Canal Block Versus Femoral Nerve Block for Quadriceps Strength and Fall-risk
Official title: The Effects of Ultrasound Guided Adductor Canal Block Versus Femoral Nerve Block on Quadriceps Strength and Fall-risk: a Blinded Randomized Trial of Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Quadriceps Muscle Weakness
Adductor Muscle Weakness
Fall Risk
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2012-08-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our objective was to determine if an ultrasound guided ACB can preserve quadriceps strength, thus minimizing weakness of knee extension compared with ultrasound guided femoral nerve block. Our primary outcome was the percent of maximum voluntary isometric contraction (MVIC) of knee extension preserved at 30 mins after either an ACB or FNB. Secondary outcomes included MVIC of knee extension at 60 min, hip adduction at 30 and 60 mins, and assessment of fall risk with the Berg Balance Scale (BBS) at 30 minutes.


Eligibility criteria: Inclusion Criteria:

* Adults (\>18yrs)
* ASA 1-2

Exclusion Criteria:

* BMI \>30
* Allergy to local anesthetics
* Pre-existing gait disturbance
* Pre-existing neuropathy

Primary outcomes:
measure: Percent of maximum voluntary isometric contraction (MVIC) of knee extension preserved at 30 mins after either an ACB or FNB
timeFrame: At 30 minutes
Secondary outcomes:
measure: Percent of maximum voluntary isometric contraction (MVIC) of knee extension preserved at 60 mins after either an ACB or FNB
timeFrame: At 60 minutes
measure: Percent of maximum voluntary isometric contraction (MVIC) of hip adduction preserved at 30 mins after either an ACB or FNB
timeFrame: At 30 minutes
measure: Percent of maximum voluntary isometric contraction (MVIC) of hip adduction preserved at 60 mins after either an ACB or FNB
timeFrame: At 60 minutes
measure: Assessment of fall risk with the Berg Balance Scale (BBS) at 30 minutes after the first nerve block.
timeFrame: At 30 minutes
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's Roosevelt Hospital
state: New York
Study officials:
References:
Clinical trial NCT05668377: Automated Diagnostic Performance of Smartwatch ECG for Arrhythmia Detection Using the PulseAI Neural Network.
Official title: Automated Diagnostic Performance of Smartwatch ECG for Arrhythmia Detection Using the PulseAI Neural Network.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arrhythmias, Cardiac
Lead sponsor: PulseAI Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beacon Hospital Research Institute, Dublin, Ireland
First posted: 2022-12-29
Enrollment: 300
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants hospitalised for ablation, cardioversion or cardiac rhythm consultation.

Brief summary: The study is to evaluate the performance of the PulseAI neural network technology at interpreting ECG data recorded using a single-lead Smartwatch (Apple Watch).

Detailed description: Under subject consent, subjects will have a 12-lead ECG immediately followed by a smartwatch ECG. The heart rhythm and ECG interval measurements will be compared between the 12-lead ECG and smartwatch ECG.

The arrhythmias will include:

* Atrial Fibrillation/Flutter
* Tachycardia
* Bradycardia
* Premature Atrial Contractions
* Premature Ventricular Contractions

Eligibility criteria: Inclusion Criteria:

* Patient aged 22 or older, able and willing to participate in the study
* Patient admitted to hospital for ablation, cardioversion, or cardiac electrophysiological exploration.
* Patient who has read the information note and has given their consent before any procedure related to the study.

Exclusion Criteria:

* Patient with a pacemaker, implantable defibrillator or cardiac resynchronisation therapy device.

Primary outcomes:
measure: Evaluate the performance of arrhythmia detection.
timeFrame: 12 months
Secondary outcomes:
measure: Evaluate the performance of the Apple Watch ECG interpretation Software compared to the PulseAI software
timeFrame: 12 months
measure: Evalaute the performance of QTc interval measurement
timeFrame: 12 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Beacon Hospital Research Institute
Study officials:
affiliation: Beacon Hospital Research Institute, Dublin
name: David Burke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04285177: Choroidal and Retinal Thickness Following Strabismus Surgery
Official title: Effect of Strabismus Surgery on Macular and Subfoveal Choroidal Thickness Assessed by Spectral Domain Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Strabismus
Retinal Thickening
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individual with strabismus fulfilling the inclusion criteria

Brief summary: Prospective study, conducted at Tanta University Ophthalmology Department Measurement of macular and choroidal thickness before and after strabismus surgery

Detailed description: This is a prospective study and will be conducted in Tanta University hospital

* Duration: February 2020 till May 2020 and may be extended
* The study will include 30 patients who suffer from esotropia or exotropia, inferior oblique (IO) over-action with or without any other type of horizontal deviation

Pre-operative measurement of the macular and choroidal thickness by Enhanced Depth Imaging Optical Coherence Tomography (EDI-OCT).

Post-operative measurement: First day, first week, one month then 3 months.

Eligibility criteria: Inclusion Criteria:

* No prior history of ocular surgery or trauma
* Normal ocular examination findings
* No medical or family history of retinal disease, glaucoma or diabetes mellitus.

Exclusion Criteria:

* Patients with orbital and/or craniofacial abnormalities
* Patients with sensory or restrictive strabismus or neurological disease
* Preoperative retinal or macular pathology
* Patient who is unable to cooperate to do OCT scanning

Primary outcomes:
measure: Choroidal and retinal thickness change after strabismus surgery
timeFrame: preoperative, 1st week, 1st month, and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
state: Gharbeya
Study officials:
affiliation: Tanta University
name: Sharif Y El Emam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04983277: Diabetes Complications and the Risk of Cardiovascular and Cerebrovascular Diseases
Official title: Study of Diabetes Mellitus and Its Complications and the Risk of Cardiovascular and Cerebrovascular Diseases
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetes Complications
Cardiovascular Diseases
Cerebrovascular Disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with diagnosis of diabetes mellitus

Brief summary: This study is intended to include 3000 diabetic patients in our hospital to collect complete medical history data, comprehensively improve the screening of diabetic complications and cardiovascular and cerebrovascular risk assessment.

Detailed description: With the economic development and lifestyle change, the incidence and prevalence of diabetes are increasing year by year in both China and the world. Diabetics are associated with a significantly increased risk of cardiovascular and cerebrovascular disease.

It is a cross-sectional study. This study intended to include about 3000 adult patients with previously diagnosed diabetes mellitus, then collect their anthropometric data (age, gender, weight, height, waist circumference, hip circumference and etc.), life history (diet, exercise, smoking, drinking and etc.), medical history, familial medical history, clinical testing results about their diabetes complication, and make a comprehensive assessment of their cardiovascular and cerebrovascular risks. These data will be used to make further research about the diabetes complication and cardiovascular and cerebrovascular disease.

Eligibility criteria: Inclusion Criteria:

* Diabetic symptoms with: plasma glucose level at any time ≥11.1mmol/ L (200mg/ dL), or Fasting plasma glucose level ≥7.0mmol/ L (126mg/ dL), or plasma glucose level ≥11.1mmol/ L (200ng/ dL) for 2 h in OGTT test, or HbA1c ≥6.5%; Or those without typical symptoms should repeated the tests in another day.
* Han Chinese.
* Willingness to participate.

Exclusion Criteria:

* Secondary diabetes.
* Participants in other clinical trials.

Primary outcomes:
measure: Framingham Risk Scose
timeFrame: 1 week
measure: UK Prospective Diabetes Study risk score
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Department of Endocrinology and Metabolism, Second Affiliated Hospital of Zhejiang University
name: Pengfei Shan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02289677: Pediatric Intubation During CPR
Official title: Comparison of the Atmos Scope, the Coopdech and the AirTraq in Pediatric Patients During Resuscitation. Randomized Crossover Manikin Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrest
Keywords: intubation
child
resuscitation
simulation
Endotracheal
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-11-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We hypothesized that the video-laryngoscopes are beneficial for intubation of pediatric manikins while performing CPR. In the current study, we compared effectiveness of two video-laryngoscopes (the Coopdech video Laryngoscope portable VLp-100 and the Flexible Videoendoscope: ATMOS Scope) and optical-laryngoscope (the AirTraq) during resuscitation with uninterrupted chest compressions using an child manikin.


Eligibility criteria: Inclusion Criteria:

* Give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medical personnel (physicians, nurses, paramedics)

Exclusion Criteria:

* Not meet the above criteria
* Wrist or Low back diseases

Primary outcomes:
measure: Success of intubation
timeFrame: 1 day
Secondary outcomes:
measure: Intubation time
timeFrame: 1 day
measure: POGO score
timeFrame: 1 day
measure: Cormack-Lehane grading
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Cardiology
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References: