louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06400745: Clareon PanOptix Pro vs. Clareon PanOptix - Study A
Official title: Contralateral Study of Clareon PanOptix Pro vs. Clareon PanOptix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia
Presbyopia
Keywords: Cataract
IOL
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2024-05-06
Enrollment: 161
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Contralateral (split face) study design
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of Clareon™ PanOptix™ Pro Trifocal Intraocular Lens (IOL) compared to Clareon™ PanOptix™ Trifocal IOL.

Detailed description: Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 7 months. The primary endpoint will be assessed at the Month 2 follow-up visit. Both eyes of a subject must qualify for enrollment into this study.

Eligibility criteria: Key Inclusion Criteria:

* Understand and sign an ethics committee-approved informed consent form;
* Willing and able to attend all scheduled study visits as required by the protocol;
* Planned cataract surgery (both eyes);
* Preoperative corneal astigmatism less that 1.00 diopter in each eye.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Women of childbearing potential if currently pregnant, intend to become pregnant during the study, or are breastfeeding;
* Ocular conditions as specified in the protocol;
* Subjects who desire monovision correction.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
timeFrame: Month 2 postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: Bloomfield Hills
country: United States
facility: Grosinger, Spigelman & Grey Eye Surgeons, P.C.
state: Michigan
city: Kansas City
country: United States
facility: Moyes Eye Center
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Mount Pleasant
country: United States
facility: Carolina Eyecare Physicians, LLC
state: South Carolina
city: Nashville
country: United States
facility: Vision for Life
state: Tennessee
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Salt Lake City
country: United States
facility: The Eye Institute of Utah
state: Utah
Study officials:
affiliation: Alcon Research, LLC
name: Principal Clinical Trial Lead, Surgical
role: STUDY_DIRECTOR
References:
Clinical trial NCT01905345: Influence of Consecutive Strength- and Endurance Regimes on the Myonuclear Domain and Satellite Cell in the M. Vastus Lateralis of Old Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regeneration Potential of Healthy Old Men in Terms of Satellite Cell Activation
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Randomised training intervention.

Influence of consecutive training regime on the impact of the myonuclear domain and satellite cell

Sarcopenia

Despite that the muscle mass can be positively influenced by training, the loading with high weights and/or to the total exhaustion is for many old persons not possible.

Therefore we aim to enhance the myonuclei in the muscle fiber of old male subjects in a first phase by endurance training, in order to promote a more effective muscle growth in a second phase by resistance exercise.


Eligibility criteria: Inclusion criteria: -male

* no fever at the beginning and during the study
* between 60 years and 75 years
* non smokers
* no known cardiovascular and orthopaedic problems
* no cardiac pacemaker
* fulfilling the health criteria

Exclusion criteria: -female

* fever or cold at the beginning or during the study
* non MRI compatible metal implants
* under 60 years or over 75 years
* smoker
* cardiovascular or orthopaedic problems
* cardiac pacemaker
* not fulfilling the health criteria

Primary outcomes:
measure: Difference in % from baseline in fibre type specific number of satellite cells, fibre type specific myonuclear domain [um^2], myonuclear number [%] in response to consecutive training regimes
timeFrame: participants will be followed for the duration of training period, an expected average of 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Neurology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Neurology
name: Hans H Jung, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02591745: International Fetal Anesthesia Database
Official title: International Fetal Anesthesia Database
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Determination of Neurological Outcomes
Keywords: Fetal
Anesthesia
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Children's Hospital Medical Center, Cincinnati
name: Universitaire Ziekenhuizen KU Leuven
name: The University of Texas Health Science Center, Houston
First posted: 2015-10-30
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mothers whose fetuses require fetal intervention for a variety of conditions. Fetuses who have undergone surgical intervention while in-utero.

Brief summary: This registry aims to gather anesthetic medications administered to fetuses directly as well as those administered via the mother during fetal intervention procedures. The goal is to assesss short and medium term outcomes as well as long term outcomes of these babies whao have received medication in utero. The long term outcomes will include but are not limited to neurodevelopmental outcomes.

Detailed description: Advances in technology have allowed for an increase in procedures performed on the fetus in utero; these procedures involve the administration of different anesthetics (sedative- hypnotic agents and or volatile agents) to the mother and sometimes directly to the fetus in order for succesful completion of the procedure. Very few instiututions in the world perform these procedures in any significant number. The establishment of this database will serve to consolidate information regarding anesthetic drugs administered for these procedures, thereby helping to establish best practice guidelines, determine medium and short term outcomes or complications and also facilitate long term neurodevelopmental assessment of children that have undergone these procedures in utero with 5 and 10 year neurodevelopmental assessment.

Eligibility criteria: Inclusion Criteria: Pregnant women, fetuses and children

Exclusion Criteria: Non-pregnant women

Primary outcomes:
measure: Fetal complications
timeFrame: Peri-operative
Secondary outcomes:
measure: Maternal hypotension or other maternal complications
timeFrame: Peri-operative period
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital, Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Titilopemi Aina, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04996745: Taking POSNA's OrthoKids to the People
Official title: Taking POSNA's OrthoKids to the People: Overcoming Knowledge Disparities in Pediatric Orthopaedic Trauma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Fracture Forearm
Pediatric ALL
Keywords: health literacy
pediatric fractures
OrthoKids
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 0
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this project is to determine the efficacy of a tablet-based educational intervention at improving orthopaedic health literacy amongst families of pediatric patients treated for fractures in an outpatient setting.

Detailed description: This project aims to reduce knowledge disparity amongst caregivers of patients presenting for pediatric fracture care. At our institution, many patients presenting with fractures do not have easy access to either technology or the internet, preventing caregivers from benefiting from educational tools such as POSNA's OrthoKids®. We are planning to increase access and improve health literacy through a simple intervention of providing tablet-based access to POSNA's Orthokids while families are waiting for their physician. Families will be randomized to either standard waiting room experience vs. tablet-based educational intervention to limit selection bias. A brief pre-visit questionnaire will be completed by all caregivers to assess fracture and cast care knowledge as well as the highest educational degree obtained by the caregiver.

Eligibility criteria: Inclusion Criteria (RCT and observational arms):

* Children with forearm fractures who presented to the CHNOLA ED. "Children" are defined as persons under the age of 18 years for this study. "Forearm fracture" is defined as a radial and or ulnar shaft fracture for this study.
* Documented radiographs must show an injury in which the fracture line is wholly located within the diaphysis of the radius or ulna.

Exclusion Criteria (RCT and observational arms):

* Fractures that require internal or external fixation
* Fractures associated with multi-system trauma
* Caregivers that do not speak English or Spanish as their first language

Primary outcomes:
measure: Change in Knowledge questionnaire scores
timeFrame: up to the second clinic followup visit (Average 6 weeks)
Secondary outcomes:
measure: Change in caregiver satisfaction scores
timeFrame: up to the second clinic followup visit (Average 6 weeks)
measure: Feedback about the OrthoKids website
timeFrame: up to the second clinic followup visit (Average 6 weeks)
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Children's Hospital of New Orleans
state: Louisiana
Study officials:
References:
Clinical trial NCT01511445: Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome
Official title: Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome; a Blinded Randomised Trial of Cancellous Structured Ceramic (CSC) Versus PEEK Cages.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiating Pain
Myelopathy
Cervicobrachial Syndrome
Keywords: Cervicobrachial pain
radicular pain
arm pain
myelopathy
radiculitis
Radiating pain with or without signs of myelopathy.
Lead sponsor: Amedica Corporation
Sponsor class: INDUSTRY
First posted: 2012-01-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study randomizes neck and arm pain patients being treated with discectomy and anterior interbody fusion into two groups: one to receive a new ceramic implant and a control group with a more traditional plastic implant. The study will measure and compare pain and disability improvement with the two products over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.


Eligibility criteria: Inclusion Criteria:

* Age 18 75 years
* Radicular signs and symptoms in one or both arms (i.e., pain, paraesthesiae or paresis in a specific nerve root distribution) or symptoms and signs of acute or chronic myelopathy.
* At least 8 weeks prior conservative treatment (i.e., physical therapy, pain medication)
* Radiographic diagnosis of cervical disc herniation and/or osteophyte at 1 level (C3-C4 to C7-T1) in accordance with clinical signs and symptoms
* Ability and willingness to comply with project requirements
* Written informed consent given by the subject or the subject's legally authorised representative

Exclusion Criteria:

* Previous cervical surgery (either anterior or posterior)
* Increased motion on dynamic studies (\> 3 mm)
* Severe segmental kyphosis of the involved disc level (\> 7 degrees)
* Patient cannot be imaged with MRI
* Neck pain only (without radicular or medullary symptoms)
* Infection
* Metabolic and bone diseases (osteoporosis, severe osteopenia)
* Neoplasma or trauma of the cervical spine
* Spinal anomaly (Klippel Feil, Bechterew, OPLL)
* Severe mental or psychiatric disorder
* Inadequate Dutch language
* Planned (e)migration abroad in the year after inclusion

Primary outcomes:
measure: Neck Disability Index
timeFrame: 24 months post-op
Secondary outcomes:
measure: Fusion Status
timeFrame: 3 mo., 6mo., 12 mo., 24 months
Other outcomes:
Locations:
city: The Hague
country: Netherlands
facility: Medical Center Haaglanden
Study officials:
affiliation: Medical Center Haaglanden
name: Mark P Arts, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01246245: Nursing Care Management of External Fixation in Hospitalization: Pin Site Infection Incidence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection
Keywords: PIN SITE INFECTION AFTER EXTERNAL FIXATION
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2010-11-23
Enrollment: 100
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: Patients after external fixation insertion

Brief summary: The incidence of pin site infection is related to the nursing management of external fixation.


Eligibility criteria: Inclusion Criteria:

* 18 year old patients

Exclusion Criteria:

* Immune Depression
* Patients who are treated with immunosupressive drugs or steroids

Primary outcomes:
measure: Pin Site Infection Incidence
timeFrame: 6 MONTH
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02149745: Effect of Calling the Patient's Name on Recovery From General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delayed Emergence From Anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 101
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to find if we can shorten the recovery time by calling the patient's name during anesthesia reversal.


Eligibility criteria: Inclusion Criteria:

* patient aged between 20-70
* patient receiving breast cancer surgery under general anesthesia with total intravenous anesthesia using remifentanil and propofol, and intubated with LMA

Exclusion Criteria:

* refusal of consent
* patients taking CNS stimulants
* general anesthesia with other agents than propofol and remifentanil
* intubated with other equipments than LMA
* chronic alcoholic patient
* patients with convulsive disorder

Primary outcomes:
measure: Difference in recovery time between the two groups
timeFrame: 1 min,2 min,3 min, 4min, 5min, 6min, 7min, 8min, 9min, 10min after stopping injection of anesthetics
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT00649545: Study of the Human Anti-TNF Monoclonal Antibody in Patients With Active Rheumatoid Arthritis
Official title: A Multi-Center Study of the Safety and Efficacy of Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Active Rheumatoid Arthritis
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Rheumatoid Arthritis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-04-01
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The primary objective of this study is to assess the safety (by collecting adverse events and serious adverse events) of adalimumab administered every other week to patients with moderately to severly active rheumatoid arthritis who have failed prior disease-modifying anti-rheumatic drugs (DMARDs).


Eligibility criteria: Inclusion Criteria:

* Patient has completed (i.e. not dropped out of) the DE013 study or fulfills criteria 2-12
* Patients 18 years of age or older
* Female is either not childbearing, defined as post-menopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or if childbearing potential, practicing an acceptable method of birth control
* Female of childbearing potential must have a negative serum pregnancy test prior to first dose of adalimumab
* Diagnosis of active RA defined by \>= 5 swollen joints and one of the following:

  * Positive RF
  * One or more joint erosions present of x-ray
  * HAQ score \> 1

Exclusion Criteria:

* Patient has failed 2 or more biologics
* Patient who had previous treatment with cyclophosphamide and chlorambucil
* Previous treatment with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibody resulting in presistent CD4 lymphopenia (CD4 lymphocytes +\< 500/mm3)
* History of cancer within the past 10 years unless successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix
* History of malignant lymphoma or leukemia regardless of treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
citation: Haraoui B, Cividino A, Stewart J, Guerette B, Keystone EC. Safety and effectiveness of adalimumab in a clinical setting that reflects Canadian standard of care for the treatment of rheumatoid arthritis (RA): results from the CanACT study. BMC Musculoskelet Disord. 2011 Nov 17;12:261. doi: 10.1186/1471-2474-12-261.
Clinical trial NCT00769847: Endoscopic Treatment for Isolated, Single Suture Craniosynostosis
Official title: Endoscopic Treatment for Isolated, Single Suture Craniosynostosis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Craniosynostosis
Keywords: Endoscopic, craniosynostosis, sagittal, synostosis
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2008-10-09
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female infants, from 1 to 6 months of age with isolated, single-suture sagittal craniosynostosis.

Brief summary: This is a prospective study to evaluate outcomes in patients undergoing endoscopic craniectomy for isolated, single-suture craniosynostosis.


Eligibility criteria: Inclusion Criteria:

* Infants 1 to 6 months of age with isolated, single-suture craniosynostosis.

Exclusion Criteria:

* Multiple suture craniosynostosis and infants older than 6 months of age.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Utah
name: Faizi Siddiqu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Obrien MO, Johnson M: Craniosynostosis, in Youmans JR (ed): Neurological Surgery, Philadelphia: WB Saunders, 1990, Vol 2, p 1328.
citation: HAAS LL. Roentgenological skull measurements and their diagnostic applications. Am J Roentgenol Radium Ther Nucl Med. 1952 Feb;67(2):197-209. No abstract available.
citation: Lannelongue M. De la craniectomie dans la microcephalie. Compt Rend Seances Acad Sci 50:1382-1385, 1890.
citation: Lane LC. Pioneer craniectomy for the relief of mental imbecility due to premature sutural closure and microcephalus. JAMA 18:49-50, 1892.
citation: Panchal J, Marsh JL, Park TS, Kaufman B, Pilgram T, Huang SH. Sagittal craniosynostosis outcome assessment for two methods and timings of intervention. Plast Reconstr Surg. 1999 May;103(6):1574-84. doi: 10.1097/00006534-199905060-00004.
citation: Jimenez DF, Barone CM. Endoscopic craniectomy for early surgical correction of sagittal craniosynostosis. J Neurosurg. 1998 Jan;88(1):77-81. doi: 10.3171/jns.1998.88.1.0077.
citation: Jimenez DF, Barone CM, McGee ME, Cartwright CC, Baker CL. Endoscopy-assisted wide-vertex craniectomy, barrel stave osteotomies, and postoperative helmet molding therapy in the management of sagittal suture craniosynostosis. J Neurosurg. 2004 May;100(5 Suppl Pediatrics):407-17. doi: 10.3171/ped.2004.100.5.0407.
citation: Murad GJ, Clayman M, Seagle MB, White S, Perkins LA, Pincus DW. Endoscopic-assisted repair of craniosynostosis. Neurosurg Focus. 2005 Dec 15;19(6):E6. doi: 10.3171/foc.2005.19.6.7.
Clinical trial NCT04704947: Clinical Study Evaluating Beta Blockers Use and Fracture Risk in Patients With Primary Osteoporosis
Official title: Clinical Study Evaluating Selective or Nonselective Beta Blockers Use and Fracture Risk in Patients With Primary Osteoporosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Beta Blocker Toxicity
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical study evaluating selective or nonselective beta blockers use and fracture risk in patients with primary osteoporosis

Detailed description: Clinical study evaluating selective or nonselective beta blockers use and if there is fracture risk in patients with primary osteoporosis

Eligibility criteria: Inclusion Criteria:

* • Male \& female osteoporotic patient aged ≥ 50 years

  * Hypertensive \& normotensive patients
  * BMD T-score ≥ 2.5 or more SD below peak bone mass

Exclusion Criteria:

* Patients on drugs that may improve osteoporosis disease state such as:

  * Angiotensin converting enzyme inhibitor (ACEI) or Angiotensin receptor blockers (ARBs), Thiazide diuretic, Nitrates, Spironolactone, Statins.

Patients on drugs that may worsen osteoporosis disease state such as:

• Corticosteroids, Loop diuretics, Anticonvulsants, Antidepressants, Aromatase inhibitors, Thyroid replacement therapy and Proton pump inhibitors.

Primary outcomes:
measure: Number of patients with fracture in each group
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University
name: Mona Abd El-Rafea Abdo, PH D
role: PRINCIPAL_INVESTIGATOR
References: