louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03951948: Optimys Femoral Stem for Total Hip Replacement
Official title: Optimys Femoral Stem for Total Hip Replacement - a Clinical and Radiologic Follow-up of Minimum One Year
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Short Stem Prosthesis
Optimys Femoral Stem
Keywords: total hip replacement
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 453
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated for a proximal femoral fracture at the University Hospital Basel between 29.10.2013 (date of introduction of the Optimys femoral component at the university hospital Basel) and 29.10.2018.

Brief summary: This retrospective observational study analyses the surgical performance, clinical and radiologic outcome as well as the rate of infections with a main focus on revision surgeries after primary implantation of the Optimys short stem femoral prosthesis.


Eligibility criteria: Inclusion Criteria:

* Patients treated with an Optimys femoral component at the University Hospital Basel between 29.10.2013 and 29.10.2018

Exclusion Criteria:

* Clinical follow up at another Institution
* Documented dissent in study participation

Primary outcomes:
measure: rate of reoperations
timeFrame: one year follow-up period after Optimys femoral stem surgery
Secondary outcomes:
measure: rate of cortical hypertrophy
timeFrame: at one year follow-up after Optimys femoral stem surgery
measure: rate of fractures
timeFrame: one year follow-up period after Optimys femoral stem surgery
measure: rate of infections
timeFrame: one year follow-up period after Optimys femoral stem surgery
measure: anatomic alignment on anterior-posterior (ap) view in Degree°
timeFrame: at one year follow-up after Optimys femoral stem surgery
measure: subsidence
timeFrame: at one year follow-up after Optimys femoral stem surgery
measure: pain at rest (yes/no)
timeFrame: at one year follow-up after Optimys femoral stem surgery
measure: pain under stress (yes/no)
timeFrame: at one year follow-up after Optimys femoral stem surgery
measure: use of analgetics (yes/no)
timeFrame: at one year follow-up after Optimys femoral stem surgery
measure: use of walking aids
timeFrame: at one year follow-up after Optimys femoral stem surgery
measure: extent of periarticular ossification (PAO) according to Brooker classification system
timeFrame: at one year follow-up after Optimys femoral stem surgery
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Orthopaedics and Trauma Surgery (DOTS).
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Martin Clauss, Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02397148: Assessment of the Morphological Concordance Between CT and Cone Beam in Sinus Imagery
Official title: Assessment of the Morphological Concordance Between CT and Cone Beam in Sinus Imagery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinonasal Pathologies
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study compares the morphological concordance between CT (computed tomography) and cone beam in sinus on 26 validated items. CT and cone beam is performed on each patient. Performances of these two imagery technics seem to be closed. Nevertheless, the exposure of the ionizing radiations is lower with the cone beam.


Eligibility criteria: Inclusion Criteria:

* man or woman older than 18 years old
* patient affected by sinonasal pathology : who show one or more of the following functional sign : anosmia, pain with sinusal origin (frontal headache, lower-orbital throbbing pain increased in anteflexion, chronic unexplained headache), nasal blockage, runny nose, epistaxis requiring the realisation of a sinus imagery overview.

Exclusion Criteria:

* Deprivation of liberty by administrative or legal decision
* patients under 18 years old
* Patients in emergency

Primary outcomes:
measure: intraclass correlation coefficient
timeFrame: 1 day
Secondary outcomes:
measure: morphological concordance between cone beam and CT
timeFrame: 1 day
measure: reproductibility INTER-OBSERVER
timeFrame: 1 day
measure: dosimetry
timeFrame: 1 day
measure: Diagnosis concordance radio-endoscopic and radio-surgical
timeFrame: 1 day
Other outcomes:
Locations:
city: Toulouse
country: France
facility: VERGEZ
Study officials:
affiliation: University Hospital, Toulouse
name: Sebastien VERGEZ, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05227248: Chocolate Dynamic Vessel Analysis
Official title: Evaluation of the Effects of Chocolate on Anatomy and Functionality of Retinal Blood Vessels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Vascular
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The study aims at evaluating the effect of dark chocolate consumption on anatomy and functionality of retinal blood vessels by comparing these same parameters after milk chocolate consumption.


Eligibility criteria: Inclusion Criteria:

* Age of 18 years or older
* Healthy volunteers
* No vascular diseases
* No ocular diseases
* Volunteers capable of understanding informed consent

Exclusion Criteria:

* Patient unable to follow the instructions
* Patient unable to come back for follow-up
* opacity of lens, cornea, or vitreous
* Allergies that contraindicate pupil dilation
* Eye diseases
* Myopia greater than -8.0 Diopter (D),
* Hyperopia greater than 5.0 D
* Astigmatism greater than -3.0 D

Primary outcomes:
measure: Retinal perfusion
timeFrame: Baseline, 2 hours after intervention
measure: Retinal vascular response
timeFrame: Baseline, 2 hours after intervention
Secondary outcomes:
measure: Visual Acuity
timeFrame: Baseline, 2 hours after intervention
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Giuseppe Querques
Study officials:
affiliation: Ospedale San Raffaele
name: Francesco Bandello, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Carlo TE, Romano A, Waheed NK, Duker JS. A review of optical coherence tomography angiography (OCTA). Int J Retina Vitreous. 2015 Apr 15;1:5. doi: 10.1186/s40942-015-0005-8. eCollection 2015.
citation: Huang Y, Zhang Q, Thorell MR, An L, Durbin MK, Laron M, Sharma U, Gregori G, Rosenfeld PJ, Wang RK. Swept-source OCT angiography of the retinal vasculature using intensity differentiation-based optical microangiography algorithms. Ophthalmic Surg Lasers Imaging Retina. 2014 Sep-Oct;45(5):382-9. doi: 10.3928/23258160-20140909-08.
citation: McClintic SM, Jia Y, Huang D, Bailey ST. Optical coherence tomographic angiography of choroidal neovascularization associated with central serous chorioretinopathy. JAMA Ophthalmol. 2015 Oct;133(10):1212-4. doi: 10.1001/jamaophthalmol.2015.2126. No abstract available.
citation: Siedlecki J, Mohr N, Luft N, Schworm B, Keidel L, Priglinger SG. Effects of Flavanol-Rich Dark Chocolate on Visual Function and Retinal Perfusion Measured With Optical Coherence Tomography Angiography: A Randomized Clinical Trial. JAMA Ophthalmol. 2019 Dec 1;137(12):1373-1379. doi: 10.1001/jamaophthalmol.2019.3731.
citation: Rabin JC, Karunathilake N, Patrizi K. Effects of Milk vs Dark Chocolate Consumption on Visual Acuity and Contrast Sensitivity Within 2 Hours: A Randomized Clinical Trial. JAMA Ophthalmol. 2018 Jun 1;136(6):678-681. doi: 10.1001/jamaophthalmol.2018.0978.
Clinical trial NCT03468348: Duloxetine for Acute Post-mastectomy Pain
Official title: Duloxetine for Acute Post-mastectomy Pain: Placebo Controlled Dose Ranging Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Keywords: duloxetine
mastectomy
postoperative pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 88
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the analgesic effect of oral dulexitine tablet (administered 2 h before surgery) as well as the ideal dose for acute postmastectomy pain.

Detailed description: patients undergoing mastectomy with axillary evacuation will be divided to four groups, Placebo group: received placebo capsule Duloxetine 30: received duloxetine 30 mg capsule Duloxetine 60: received duloxetine 60 mg capsule Duloxetine 90: received duloxetine 90 mg capsule the study medication is administered orall 2 h before surgery. Primary outcome variable: the first postoperative 24 h morphine consumption Secondary outcome: the VAS pain score measured every 4 h in the first 24 h postoperatively.

Eligibility criteria: Inclusion Criteria:

* Adult females scheduled for unilateral MRM with axillary evacuation for breast cancer,
* American Society of Anesthesiologists physical status (ASA) class I and II

Exclusion Criteria:

* Patients with a known allergy to Duloxetine or morphine,
* A history of drug or alcohol abuse,
* Patients with impaired kidney or liver functions,
* Patients with chronic pain or regularly receiving analgesics,
* Any psychiatric illness that would interfere with the perception and the assessment of pain.
* Any reason that resulted in the protocol violation.

Primary outcomes:
measure: the first postoperative 24 h (patient controlled analgesia [PCA])morphine consumption
timeFrame: the first postoperative 24 hour
Secondary outcomes:
measure: The intensity of pain measured by visual analogue pain scale (VAS)
timeFrame: The outcome will be assessed at 0 hour, 2 hour, 4 hour,8 hour, 16 hour and 24 hour postoperatively.
measure: The quality of postoperative recovery, assessed by "The QoR-40 questionnaire" (the quality of recovery-40 questionnaire)
timeFrame: the questionnair will be assessed once, 24 hour postoperatively
measure: The level of consciousness assessed by "the Modified Ramsay Sedation score"
timeFrame: the score will be measured at 8 hour, 16 hour and 24 hour postoperatively
measure: The occurrence of vomiting
timeFrame: The outcome will be obtained once 24 hour postoperatively
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Diab
state: Assuit
Study officials:
References:
citation: Hetta DF, Elgalaly NA, Hetta HF, Fattah Mohammad MA. Preoperative Duloxetine to improve acute pain and quality of recovery in patients undergoing modified radical mastectomy: A dose-ranging randomized controlled trial. J Clin Anesth. 2020 Dec;67:110007. doi: 10.1016/j.jclinane.2020.110007. Epub 2020 Aug 22.
Clinical trial NCT04353648: Assessing Muscle Metabolic Phenotype by MSK Ultrasound
Official title: Assessment of Muscle Metabolic Phenotype by the Use of Point-of-care MSK Ultrasound Imaging.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ultrasound
CT
MuscleSound
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted to a Duke Trauma center, SICU, MICO, or CT ICU

Brief summary: The purpose of this study is to test whether ultrasound images (pictures) can be used as a valid assessment of muscle quality in different muscle groups during Intensive Care stay. This new approach would allow clinicians to obtain frequent skeletal muscle images and would enable doctors to observe any changes over time in muscle quality that could occur during ICU stay.

Participants in this study will have ultrasound images made of their leg-, chest- and jaw muscles taken on every day until ICU discharge.


Eligibility criteria: Inclusion Criteria:

* admission Duke Trauma center, SICU, MICU, or CT ICU
* \>18 years of age

Exclusion Criteria:

* \<18 years of age
* prisoners

Primary outcomes:
measure: Muscle Quality from the rectus femoris, vastus lateralis, intermedius, intercostalis, temporalis and styloglossus
timeFrame: Minimum of every other day while in ICU (up to 10 days). Once discharged from ICU minimum of 3x a week until discharge (up to 3 weeks)
measure: Muscle volume and thickness from the rectus femoris, vastus lateralis, intermedius, intercostalis, temporalis and styloglossus
timeFrame: Minimum of every other day while in ICU (up to 10 days). Once discharged from ICU minimum of 3x a week until discharge (up to 3 weeks)
Secondary outcomes:
measure: Changes of Intramuscular adipose tissue (IMAT) content and muscle volume/thickness from the psoas at the Level of L3/L4
timeFrame: Up to 1 year
measure: Changes of Intramuscular adipose tissue (IMAT) content and muscle volume/thickness from the intercostal muscle at the Level of Th3/Th4
timeFrame: Up to 1 year
measure: Changes of Intramuscular adipose tissue (IMAT) content and muscle volume/thickness from the intercostal muscle at the Level of the head
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Paul Wischmeyer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00850148: Comparison of Anwar and Melles Techniques in Deep Anterior Lamellar Keratoplasty (DALK) for Keratoconus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratoconus
Keywords: Anwar
Melles
Keratoconus
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-02-24
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief summary: This study will be performed on patients who come to labbafinejad ophthalmic clinic from 20 March 2008. Keratoconus diagnosis will be determined by clinical finding in slit lamp, keratometery and topographic characteristics. Patients will be randomly placed in group A and B. In group A, Anwar surgical method and in B, Melles surgical method, will be done. This is not a blind study due to surgeons' knowledge. All patients will receive Btamethazone drop and Chloramphenicol every 6 hours and will be tapered in two months. In the end anatomical results, complications, BCVA, UCVA, astigmatism, endothelial cell numbers will be compared in two groups by using specular microscopy. Contrast sensivity, central corneal diameter, interface wrinkling and opacity will be measured by metrovison, Confoscan, Photoslit in months 3, 6, 12, respectively and will be evaluated afterwards.


Eligibility criteria: Inclusion Criteria:

* patients with keratoconus
* 15\<age\<45
* contact lens intolerance

Exclusion Criteria:

* Having a history of any other ophthalmic or systemic problem
* Central corneal scar
* descemet's membrane detachment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophtalmic Research Centre
city: Tehran
country: Iran, Islamic Republic of
facility: Farid Karimian,MD
Study officials:
References:
Clinical trial NCT00006448: Treatment of Chronic Pain After Spinal Cord Injury (SCI) or Amputation
Official title: Spinal Cord Injury (SCI) and Amputation Pain Prevention and Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Amputation, Traumatic
Pain
Keywords: Spinal cord injury
Amputation
Pain management
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2000-11-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pain is a major problem for people after spinal cord injuries and amputations. This is a study to test how pain is affected by adding methadone to a six-week program of weekly physical therapy, relaxation training and counseling. Individuals who qualify for this study will receive a comprehensive medical and physical therapy evaluation.

Detailed description: Pain has a major impact on the functioning of individuals with spinal cord injuries and individuals with amputations. This double-masked randomized trial to evaluate the utility of a combination of psychological intervention and physical therapy in order to improve pain reduction, increase physical functioning and quality of life for patients with pain associated with spinal cord injuries or amputations will compare the effect of a 6 week program of physical therapy and cognitive-behavioral therapy with methadone to one without methadone (n = 400). Secondary outcomes are to evaluate the maintenance of effects of the combined intervention and to evaluate the usefulness of a course of opioid therapy compared to active placebo medication. Based on the sample size, all measures have greater than 0.7 power to detect major within group differences at posttreatment, 6-month follow-up, and 12-month follow-up (taking into account a 15% attrition rate, alpha .05). Patients who qualify for this study will receive a comprehensive medical and physical therapy evaluation at baseline. Outcome will be assessed by the physician, psychiatrist and physical therapist who are all masked both to the treatment condition and therapy. Pain is assessed through self-report (measures include pain inventories) and clinical interview.

Eligibility criteria: Inclusion Criteria:

* Individuals with spinal cord injury or amputation, who have persistent pain of three months or longer duration.

Exclusion Criteria:

* Pregnant women
* Allergy to latex, methadone, or diphenhydramine
* Surgery planned
* History of substance abuse in past two years
* History of major psychiatric disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburg Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Thomas E. Rudy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03546348: Carrying Angle From Birth to Adolescents
Official title: Normal Value of Carrying Angle in the Elbow From Birth to Adolescents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Birth
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -all normal children who are in Bangkok are enrolled in the study .There are 17 groups start from 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16 years old including both sex.

each group has 15 boys and 15 girls All are measured the carrying angle in both right and left elbow in full extension and supination

Brief summary: The carrying angle in the elbow in children is very important.Most of the results of treatment in fracture around the elbow have to measure the carrying angle.The common deformity of the elbow from cubitus varus is the change of the carrying of the elbow.There are many researches studied in normal value of the carrying angle but few had study the carrying angle from birth to adolescent.This study want to compare the carrying angle in different age and gain the knowledge of development of the carrying angle in children

Detailed description: The study is to measure the carrying angle of the children from birth to adolescents

Eligibility criteria: Inclusion Criteria:

* normal children age 0 day to 16 years old
* Thai nationality

Exclusion Criteria:

* no history of fracture around the elbow or upper extremity
* no congenital anomalies or abnormal bone that interfere the upper extremity
* no genetic diseases and skeletal dysplasia
* no deformity of the elbow or upper extremity
* refuse to enrolled in the study

Primary outcomes:
measure: carrying angle
timeFrame: 1 year
Secondary outcomes:
measure: age
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Prof.Dr.Kamolporn Kaewpornsawan
Study officials:
References:
citation: Baughman FA Jr, Higgins JV, Wadsworth TG, Demaray MJ. The carrying angle in sex chromosome anomalies. JAMA. 1974 Nov 4;230(5):718-20. No abstract available.
citation: Balasubramanian P, Madhuri V, Muliyil J. Carrying angle in children: a normative study. J Pediatr Orthop B. 2006 Jan;15(1):37-40. doi: 10.1097/01202412-200601000-00008.
citation: Beals RK. The normal carrying angle of the elbow. A radiographic study of 422 patients. Clin Orthop Relat Res. 1976 Sep;(119):194-6.
Clinical trial NCT06299748: A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy And/or Breastfeeding.
Official title: A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy And/Or Breastfeeding
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myasthenia Gravis
CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
Lead sponsor: argenx
Sponsor class: INDUSTRY
First posted: 2024-03-08
Enrollment: 279
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women or women no longer pregnant at the time of study enrollment but exposed to efgartigimod any time within 25 days prior to conception or any time during the pregnancy.

Brief summary: This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod or efgartigimod PH20 SC only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries/regions as the countries/regions in which the efgartigimod or efgartigimod PH20 SC exposed pregnancies were reported.


Eligibility criteria: Inclusion Criteria:

* Women with exposure to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy, or women with exposure to efgartigimod or efgartigimod PH20 SC during breastfeeding. The timeframe of 25 days prior to conception is calculated based on five times the efgartigimod half-life, which is 3 to 5 days.
* Written/verbal informed consent or eConsent (depending on country regulations) (for adolescents under the age of majority, written/verbal informed assent or eConsent by the pregnant minor (where applicable) and written/verbal informed consent or eConsent by the parent/legal guardian).

Exclusion Criteria:

* None

Primary outcomes:
measure: Pregnancy outcomes
timeFrame: up to 10 years
Secondary outcomes:
measure: Congenital malformations
timeFrame: up to 10 years
measure: The number of observed other events of interest in the developing neonate and infant (such as hospitalizations for serious illness)
timeFrame: up to 10 years
measure: Maternal complications of pregnancy
timeFrame: up to 10 years
measure: Maternal infections
timeFrame: up to 10 years
measure: The number of observed fetal growth deficiency
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: United BioSource LLC
state: West Virginia
Study officials:
References: