louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00352560: Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)
Official title: Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: Patients with Paroxysmal Atrial Fibrillation (PAF)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2006-07-14
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of the study is to compare the mean AERP between treatment groups based on the hypothesis that in subjects with paroxysmal AF, Irbesartan prevents electrophysiological remodeling resulting in a prolonged atrial effective refractory period relative (AERP) to placebo.


Eligibility criteria: Inclusion Criteria:

* Recurrent PAF with indication for catheter ablation

Exclusion Criteria:

* Struct. Cardiopathy
* Mitral valve disease
* VEF\<40%
* Myocardiopathy
* LVH
* cardiac surgery
* AF reversible
* QT c\>450
* Recent MI/stroke, severe HTN
* Requirement of ACEI/ARBs
* Coronary synd., HTA, liver disease

Primary outcomes:
measure: Irbesartan effect on duration of Atrial Effective Refractory Period (AERP) in paroxysmal AF (PAF) patients.
timeFrame: The measures are taken after 31 days of irbesartan treatment
Secondary outcomes:
measure: Irbesartan effect on A Function RP
timeFrame: The measures are taken after 31 days of irbesartan treatment
measure: Irbesartan effect on atrial conduction intervals after basal & extra-stimuli, in PAF patients
timeFrame: The measures are taken after 31 days of irbesartan treatment
measure: Refractoriness dispersion
timeFrame: The measures are taken after 31 days of irbesartan treatment
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
Study officials:
affiliation: Medical Department, Bristol-Myers Squibb
name: Miguel Angel Sanchez Zamorano, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01313260: Structural and Functional Connectivity in Partial Epilepsies Studied with MRI and MEG
Official title: Structural and Functional Connectivity in Partial Epilepsies Studied with MRI and MEG
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsies
Keywords: Refractory partial epilepsies
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2011-03-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Refractory partial epilepsy patients

Brief summary: Surgery may be an effective therapy for refractory focal epilepsies with a clear delineated focus but surgical benefits are less clear for patients with a poorly defined focus such as non lesional refractory partial epilepsies.

SEEG is considered the criterion standard to localize the epileptogenic zone (EZ) but the procedure is risky with a limited spatial sampling. The development of non-invasive neuroimaging alternatives is thus an important goal to improve EZ delineation and optimize SEEG procedures.

The main hypothesis of this research project is the existence of a network organization specific for each patient which allows the generation and propagation of epileptic activities. The investigators wish to explore this network using diffusion tensor MRI to study structural connectivity and MEG/FMRI to study functional connectivity. The investigators will apply tools from the theories of complex networks and dynamical systems to characterize the network organization of epileptic process.

The investigators aimed to identify and localize differences in connectivity parameters between individual patients and a control group of healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* intracranial EEG recordings scheduled
* no neurological or psychiatric disease for healthy volunteers

Exclusion Criteria:

* contraindication to MRI
* pregnancy

Primary outcomes:
measure: Epileptic network assessed using structural and functional connectivity measures obtained with MRI and MEG
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: ICM (Brain and Spine Institute)
Study officials:
References:
citation: Chavez M, Valencia M, Navarro V, Latora V, Martinerie J. Functional modularity of background activities in normal and epileptic brain networks. Phys Rev Lett. 2010 Mar 19;104(11):118701. doi: 10.1103/PhysRevLett.104.118701. Epub 2010 Mar 18.
Clinical trial NCT03562260: Bipolar Surgical Release in Congenital Muscular Torticollis
Official title: Result of Bipolar Surgical Release in Congenital Muscular Torticollis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Muscular Torticollis
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: only 1 group in children who received the bipolar release
Primary purpose: TREATMENT

Brief summary: The congenital muscular torticollis is common disease in children.The indication for surgery is the children have persist deformity after 1 year old.Many surgical treatment had proposed such as unipolar release and bipolar release.By author experience the bipolar release had better results from complete cut the muscle both origin and insertion.This study wants to study the results of treatment in term of recurrence of the deformity.

Detailed description: the study perform in children with congenital muscular torticollis

Eligibility criteria: Inclusion Criteria:

* 1. all children age ranged from 5-15 years old who received the surgical treatment by bipolar release in the hospital.

Exclusion Criteria:

* 1. no history of surgery at the neck 2. no history of congenital anomalies and syndrome that effect the neck

Primary outcomes:
measure: ImageJ scoring system
timeFrame: no torticollis after 1 year of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Prof.Dr.Kamolporn Kaewpornsawan
Study officials:
affiliation: Department of Orthopaedic Surgery,Faculty of Medicine,Siriraj Hospital,Mahidol University,Bangkok,Thailand
name: Prof.Dr.Kamolporn Kaewpornsawan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee EH, Kang YK, Bose K. Surgical correction of muscular torticollis in the older child. J Pediatr Orthop. 1986 Sep-Oct;6(5):585-9. doi: 10.1097/01241398-198609000-00011.
citation: Sudesh P, Bali K, Mootha AK, Dhillon MS. Results of bipolar release in the treatment of congenital muscular torticolis in patients older than 10 years of age. J Child Orthop. 2010 Jun;4(3):227-32. doi: 10.1007/s11832-010-0254-x. Epub 2010 Mar 26.
citation: Shim JS, Jang HP. Operative treatment of congenital torticollis. J Bone Joint Surg Br. 2008 Jul;90(7):934-9. doi: 10.1302/0301-620X.90B7.20339.
Clinical trial NCT05947760: Magnesium As an Adjuvant Agent for Postoperative Pain
Official title: Magnesium As an Adjuvant Agent for Postoperative Pain Control Following Periacetabular Osteotomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: periacetabular osteotomy
IV magnesium sulfate
Decreased opioid usage
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 64
Sex: ALL
Minimum age (years): 14
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Participants are being asked to participate in this research study because they have elected to undergo periacetabular osteotomy (PAO). This research study is looking at if using IV magnesium during surgery can help to reduce pain after surgery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing periacetabular osteotomy with or without adjuvant hip arthroscopy

Exclusion Criteria:

* illiterate or non-English speaking patients
* patients with 2nd or 3rd degree AV block
* patients with severe renal insufficiency
* patients with heart failure
* patients with bradycardia

Primary outcomes:
measure: Change in pain as measured by the Visual Analog Scale (VAS)
timeFrame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
measure: Change in number of narcotic medications consumed as measured by the medical record review
timeFrame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Secondary outcomes:
measure: Change in PROMIS scores
timeFrame: 2 weeks, 6 weeks, 3 months, 6 months, 1 year
measure: Change in modified Harris Hip Scores (mHHS)
timeFrame: 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
Study officials:
affiliation: University Hospitals
name: Robert Wetzel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03733860: Cavernous Tissue Preservation During Penile Prosthesis Implantation
Official title: Preservation of Penile Tumescence by Cavernous Tissue Preservation During Penile Prosthesis Implantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction
Keywords: erectile dysfunction
penile tumescence
cavernous tissue
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spontaneous penile tumescence after penile prosthesis implantation has been previously reported as sporadically occurring during implant surgery. This study aims at systematically preserving residual erectile function, by the preservation of the patients' spontaneous penile tumescence by systematically sparing cavernous tissue during penile prosthesis implantation.

Detailed description: Patients undergoing the cavernous tissue sparing penile implant procedure will be injected intraoperatively with 40µg alprostadil, a prostaglandin E1 agonist intracorporal injection (ICI). The procedure will begin as soon as maximal tumescence is attained.

In the cavernous sparing group, corporal dilation will be done solely with a size 8 dilator. The insertion of the dilator will be carefully inserted in what we call the path of least resistance. To determine the path of least resistance, the corporotomy is spread apart by pulling on previously set stay sutures. The path of least resistance is the plane with maximum outflow of blood from the intraoperatively pharmaceutically dilated and blood filled corpora cavernosa. This plane can also be anticipated with a preoperative penile duplex.

Eligibility criteria: Inclusion Criteria:

* Erectile dysfunction not amenable to treatment by approved medical therapy

Exclusion Criteria:

* Erectile dysfunction amenable to treatment by approved medical therapy

Primary outcomes:
measure: Cavernous tissue thickness postoperatively measured by ultrasound
timeFrame: 1 month
Secondary outcomes:
measure: Presence of spontaneous penile tumescence post operatively
timeFrame: 1 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Adham Zaazaa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zaazaa A, Bayerle-Eder M, Elnabarawy R, Elbitar M, Mostafa T. Penile Hemodynamic Response to Phosphodiesterase Type V Inhibitors after Cavernosal Sparing Inflatable Penile Prosthesis Implantation: A Prospective Randomized Open-Blinded End-Point (PROBE) Study. Adv Urol. 2021 Jun 28;2021:5548494. doi: 10.1155/2021/5548494. eCollection 2021.
Clinical trial NCT05042960: Computer Screen Properties Study
Official title: Investigating the Effects of Screen Brightness and Warm Tone Modulation on Dry Eye Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to identify how various popular methods of changing computer screen settings affect dry eye symptoms (eye pain, grittiness, tearing, burning, etc.). Specifically, this study will examine if there are differences in effects of blue light blocking (F.lux app or night shift) versus reducing screen brightness on the symptoms of dry eye.

Detailed description: After the initial survey, participants will be randomized by a randomization tool internal to Redcap to be in one of three arms of intervention: no intervention, screen brightness reduction to 50%, and tone modulator application. Instructions will be e-mailed to participants to explain the steps they must take depending on which treatment arm they are randomized to. Adherence will be monitored and assessed at the time of post-intervention survey. If participants have issues with the software of complying, they will be able to contact the research team at any point.

Eligibility criteria: Inclusion Criteria:

* Adult person (18+) with intact vision who uses computers

Exclusion Criteria:

* Children (\<18 years)
* Adult person without intact vision
* Adult who does not use computer screens

Primary outcomes:
measure: The frequency of dry eye symptoms
timeFrame: Day 1
measure: The frequency of dry eye symptoms
timeFrame: Day 30
measure: The severity of dry eye symptoms
timeFrame: Day 1
measure: The severity of dry eye symptoms
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Leela Raju, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03154060: Evaluation of the Accuracy and Precision of Flash Glucose Monitoring Sensors in Different Sites
Official title: Evaluation of the Accuracy and Precision of Flash Glucose Monitoring Sensors in Different Sites: the Abdomen and Upper Thigh Compared to the Upper Arm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Flash glucose monitoring
Accuracy
Precision
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Onze Lieve Vrouwziekenhuis Aalst
First posted: 2017-05-15
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open-label, prospective, single-arm study
Primary purpose: OTHER

Brief summary: On the first of July 2016, reimbursement for the Freestyle Libre Flash Glucose Monitoring (FGM) was introduced by the Belgian healthcare authority by means of a new diabetes convention. Making this the only way to receive the device in Belgium. Since then, many type 1 diabetes (T1D) patients switched to FGM. But some patients found the sensor on the upper arm too visible. Abbott does not recommend to place the sensor on a different place of the body than the back of the upper arm, because no tests were done yet (besides on the upper arm) to make an accuracy claim. With this study, we want to evaluate the accuracy and the precision of the Freestyle Libre FGM by using three FGM sensors simultaneously on different places of the body and perform regular self-monitoring of blood glucose (SMBG) tests.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of T1D for more than 6 months
* Adult patients ≥ 18 years
* Signed informed consent form

Exclusion Criteria:

* Pregnancy
* Patients with severe cognitive dysfunction or other disease which makes FGM use difficult.
* History of allergic reaction to any of the FGMs materials or adhesives when in contact with the skin.
* History of allergic reaction to chlorhexidine or alcohol anti-septic solution.
* Abnormal skin at the anticipated glucose sensor insertion sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
* Presence of concomitant pathology that might cause edema at the insertion sites (such as heart failure, liver failure, kidney failure defined as eGFR \< 45 ml/min).

Primary outcomes:
measure: Mean Absolute Relative Difference
timeFrame: 14 days
Secondary outcomes:
measure: Precision Absolute Relative Deviation
timeFrame: 14 days
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis Aalst
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT00608660: Randomized Controlled Trial of Acupuncture to Treat Bell's Palsy According to Different Stages
Official title: Studying of Acupuncture for Bell's Palsy According to Different Stages
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bell's Palsy
Keywords: Peripheral Facial Paralysis
Acupuncture
RCT
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2008-02-06
Enrollment: 900
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial will certify the efficacy of using staging acupuncture and moxibustion to treat Bell's Palsy

Detailed description: The result of this trial (available in 2009) aims to testify the efficacy of using staging acupuncture and moxibustion to treat Bell's Palsy, and to approach a best acupuncture treatment among these five different methods for treating Bell's Palsy

Eligibility criteria: Inclusion Criteria:

* patients who meet the diagnosis, stages, location criteria
* the first time to onset the disease
* between 1 and 70 days with the onset time of facial palsy
* on one side of the face paralysis
* between 15 and 70 years old with the onset age of facial palsy
* willing to finish the whole observation period
* with written consent form signed by themselves.

Exclusion Criteria:

* facial palsy caused by other disease, such as infectivity multiple radiculitis, tumor which offend temporal bone, cerebral trauma
* facial palsy combine diabetes, the severe disease of heart vessel, cerebral vessel, liver, kidney, lung, and psychosis
* patient with Hunt's syndrome
* patient with facial spasm
* pregnant women or women in lactation
* patients are participating other clinical research

Primary outcomes:
measure: House-Brackmann scale （Global Score）
timeFrame: a week
Secondary outcomes:
measure: Classification Score Of Facial Paralysis Degree
timeFrame: a week
measure: Facial Disability Index
timeFrame: a week
measure: WHOQOL-BREF scale
timeFrame: two week
measure: House-Brackmann scale （Regional Score）
timeFrame: a week
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu university of TCM
state: Sichuan
Study officials:
affiliation: Acupuncture&Moxibustion college of chengdu TCM
name: Ying Li, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhao L, Zhang FW, Li Y, Wu X, Zheng H, Cheng LH, Liang FR. Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. Trials. 2011 Mar 24;12:87. doi: 10.1186/1745-6215-12-87.
Clinical trial NCT00333060: Study of OT-551 Eye Drops to Prevent or Delay Progression of Nuclear Cataracts Following Vitreous Removal
Official title: Phase 2 Study of OT-551 Ophthalmic Solution to Prevent or Delay Progression of Nuclear Cataract Formation In Post-Vitrectomy Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Epiretinal Membrane
Macular Hole
Lead sponsor: Othera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-06-02
Enrollment: 164
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this trial is to compare the ability of two doses of OT-551 ophthalmic solution and drug-free solution to safely and effectively prevent or delay the progression of nuclear cataracts that frequently develop as a result of vitrectomy (surgery for retina repair), thereby avoiding the need for a second surgery (cataract removal). Victrectomies involve removal of the jelly-like substance (vitreous) that is located in a cavity behind the lens.


Eligibility criteria: Inclusion Criteria:

* Imminent vitrectomy to repair macular holes or puckers
* Ability to be screened for eligibility and begin dosing 7-10 days in advance of the surgery
* Best corrected ETDRS visual acuity equivalent to Snellen 20/400 or better in the surgical eye and 20/100 or better in the fellow eye

Exclusion Criteria:

* Artificial lens or no lens in the surgical eye
* Cataract (greater than slight opacity or thickness) in the surgical eye
* Any other retinal abnormality which may be vision-threatening
* Serious heart, kidney, or liver disease
* Recent ophthalmic surgery (within 6 months) or ocular infection (within 30 days)
* Poorly controlled diabetes or unstable glaucoma

Primary outcomes:
measure: change in visual acuity
measure: change in lens opacity
Secondary outcomes:
Other outcomes:
Locations:
city: Peoria
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Miami
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Joliet
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Cherry Hill
country: United States
state: New Jersey
city: Forrest Hills
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Bala Cynwyd
country: United States
state: Pennsylvania
city: West Chester
country: United States
state: Pennsylvania
city: Abilene
country: United States
state: Texas
Study officials:
References: