louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00759668: Visual Function and Patient Satisfaction After Bilateral Implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 35
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is:

* to compare visual parameters (Subjective refraction and Visual Acuity (VA)) and safety (tilt, decentration and posterior chamber opacification (PCO)) in a prospective series of 40 patients after bilateral implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)
* to assess patient satisfaction before and after implant


Eligibility criteria: Inclusion:

* Written informed consent
* Age: ≥ 50 years ≤ 75 years
* Bilateral age related cataract, to be extracted and followed by the implantation of Posterior Chamber Intraocular Lenses (IOLs)
* Pre-operative and post-operative astigmatism ≤ 1 Diopter (D), as from Keratometry readings
* Potential post operative Visual Acuity (VA) ≥ 20/40
* Second eye surgery to take place no longer than 45 days after the first implant

Exclusion:

* Irregular optical aberrations;
* Pupil diameter in scotopic conditions more than 6 mm
* Degenerative visual pathologies (ex: Age-related Macular Degeneration (AMD))
* Other exclusions as from ReSTOR Directions for Use (DFU)

Primary outcomes:
measure: Near Best Corrected Visual Acuity (BCVA) - Binocular
timeFrame: 6 months after second eye implantation
measure: Near Uncorrected Visual Acuity (UCVA) Binocular
timeFrame: 6 months after second eye implantation
measure: Near Best Corrected Visual Acuity Left Eye (BCVA LE)
timeFrame: 6 months after second eye implantation
measure: Near Uncorrected Visual Acuity Left Eye (UCVA LE)
timeFrame: 6 months after second eye implantation
measure: Near Best Corrected Visual Acuity Right Eye (BCVA RE)
timeFrame: 6 months after second eye implantation
measure: Near Uncorrected Visual Acuity Right Eye (UCVA RE)
timeFrame: 6 months after second eye implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT04374968: Use of Blood Flow Restriction Therapy Following ACL Tear
Official title: Use of Blood Flow Restriction (BFR) Therapy in Peri-operative Rehabilitation Following Anterior Cruciate Ligament Tear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Tear
Knee Injuries
Sport Injury
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel randomized controlled trial with a treatment and control group
Primary purpose: TREATMENT

Brief summary: Evaluating the use of peri-operative blood flow restriction therapy surrounding anterior cruciate ligament tear

Detailed description: The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy both before and after anterior cruciate ligament reconstruction (ACLR) following a tear. BFR has been proposed to work by restricting arterial inflow leading to an oxygen depleted environment and the ability to induce muscle adaption at lower maximum repetition via reactive hyperemia. Muscle atrophy occurs following ACL tear and reconstruction. Thus, physical therapy is used in the peri-operative period to regain strength with the ultimate goal of returning to activity.

The goal of this investigation is to determine if using BFR during perioperative therapy would lead to increased and expedited strength gains. Additionally we would like to determine if BFR helps patients to pass the standard rehabilitative functional tests and return to play sooner. We will also look at patient reported outcomes metrics and pain scores to determine if BFR has a significant impact on the patient experience surrounding ACL tear and reconstruction.

Eligibility criteria: Inclusion Criteria:

* ACL tear undergoing reconstruction

Exclusion Criteria:

* History of pulmonary embolism
* History of deep vein thrombosis
* Family history of PE/DVT
* Hypercoaguable disorder
* Multiligamentous knee injury
* Neurovascular injury
* Peripheral vascular disease
* Unable to complete physical therapy
* Unable to tolerate blood flow restriction

Primary outcomes:
measure: Quadriceps Strength
timeFrame: Three months
Secondary outcomes:
measure: Quadriceps Strength
timeFrame: six months
measure: Knee range of motion
timeFrame: three months
measure: Knee range of motion
timeFrame: six months
measure: Patient reported outcome measurement information system
timeFrame: Three months
measure: Patient reported outcomes measurement information system
timeFrame: Six months
measure: international knee documentation committee questionnaire
timeFrame: three months
measure: international knee documentation committee questionnaire
timeFrame: six months
measure: Pain scores
timeFrame: three months
measure: Pain scores
timeFrame: six months
Other outcomes:
Locations:
city: West Bloomfield
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
References:
Clinical trial NCT00534768: Postoperative Treatment After Endoscopic Sinus Surgery
Official title: Postoperative Treatment After Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinusitis
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2007-09-26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: Even though postoperative debridement is commonly considered as an essential part of endoscopic sinus surgery (ESS), the scientific data on the efficacy or the optimal timing of debridement is limited. In the present study, the effect of repeated debridement during the first week after ESS on the endoscopic and subjective outcome was evaluated.

Study Design: Open, prospective, randomized, controlled clinical trial with two parallel groups.

Methods: A total of 90 patients suffering from either recurrent or chronic maxillary sinusitis were randomized into two groups after ESS. In the active group, the nasal cavities were debrided three times on the first postoperative week, while in the control group the patients were debrided only once on the 7th postoperative day. The primary outcome measure was the presence of scarring in the middle meatus at four weeks after ESS.


Eligibility criteria: Inclusion Criteria:

* A total of 90 patients (age 18-70 years), who underwent ESS in Kuopio University Hospital, Kuopio, Finland were included in this study.
* The patients suffered from either recurrent or chronic maxillary sinusitis and had American Society of Anaesthesiologists physical status 1 or 2.{{331 Sakland,M. 1941; }}

Exclusion Criteria:

The patients were excluded if they had:

* Undergone previous sinus surgery or if they had severe nasal polyposis (radiological opacification more than 50 % of the sinuses (Lund-McKay classification)
* Hemorrhagic diathesis
* Liver or kidney dysfunction
* Chronic malnutrition
* Alcoholism or inflammatory bowel disease.

Other exclusion criteria were pregnancy and ongoing anticoagulant therapy.

Primary outcomes:
measure: scarring in middle meatus 4 weeks after ESS
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: Kuopio University Hospital
name: Tatu p Kemppainen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kuopio University
name: Juhani Nuutinen, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03285568: Patterns of Prescribing and Monitoring of Palbociclib
Official title: Patterns of Prescribing and Monitoring of Palbociclib
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Advanced Breast Cancer
Estrogen Receptor-positive Breast Cancer
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients seen at RUMC

Brief summary: The purpose of this study is to determine if patients with ER+, human epidermal growth factor 2 negative (HER2-), advanced breast cancer are receiving dosing adjustments and monitoring based on manufacturer recommendations at a tertiary academic medical center.

Detailed description: This study was a retrospective, single-center study that included women receiving palbociclib for the treatment of ER+, HER2- advanced breast cancer. Exclusion criteria were the presence of brain metastases or active enrollment in a palbociclib clinical trial.

The primary endpoint was the proportion of patients who were maintained on a palbociclib dose according to the adjustment schedule in package insert recommendations.

The secondary endpoints were the number of patients dose adjusted for hematologic toxicities, the number of patients experiencing neutropenia, duration of therapy, progression-free survival (PFS), and adherence to manufacturer monitoring recommendations.

Eligibility criteria: Inclusion Criteria:

* women at least 18 years old
* ER+, HER2- advanced breast cancer
* receiving palbociclib

Exclusion Criteria:

* brain metastases
* on palbociclib clinical trial

Primary outcomes:
measure: Palbociclib dose according to the package insert recommendations.
timeFrame: 22 months
Secondary outcomes:
measure: Dose adjustment for hematologic toxicities
timeFrame: 22 months
measure: Number of patients who experienced neutropenia.
timeFrame: 22 months
measure: Duration of therapy
timeFrame: 22 months
measure: Progression free survival (PFS)
timeFrame: 22 months
measure: Adherence to manufacturer monitoring recommendations
timeFrame: 22 months
Other outcomes:
Locations:
Study officials:
affiliation: Rush University Medical Center
name: Kathryn Schultz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02382068: Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin
Official title: Prevention of Cisplatin-Induced Ototoxicity by Intratympanic Dexamethasone
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Malignant Neoplasm
Ototoxicity
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized pilot clinical trial studies dexamethasone in preventing hearing loss in patients receiving cisplatin. Injecting a steroid, such as dexamethasone, behind the eardrum before chemotherapy may help protect against cisplatin-associated hearing loss.

Detailed description: PRIMARY OBJECTIVES:

I. Investigate the potential protective effect of intratympanic dexamethasone administration on cisplatin-induced ototoxicity.

OUTLINE: Patients are randomized as to which ear receives dexamethasone.

Patients receive dexamethasone via intratympanic injection in one ear and placebo via intratympanic injection in the other ear.

After completion of study treatment, patients are followed up before each cisplatin treatment and then at 1 and 3 months after the last cisplatin treatment.

Eligibility criteria: Inclusion Criteria:

* Planned cisplatin treatment restricted to the following treatment course criteria:

  * Dose: \> 50 mg/m\^2
  * Frequency: every (q)3-q4 weeks
  * Cycles: 7 maximum

Exclusion Criteria:

* Previous cisplatin treatment
* Previous or concurrent radiation treatment to the head and neck region
* Previous or existing pathology of the external or middle ear which would preclude auditory testing and/or intratympanic dexamethasone delivery
* Previous or existing pathology of the inner ear with or without hearing loss (i.e. sudden sensorineural hearing loss, Meniere's disease, autoimmune inner ear disease)
* Previous or existing pathology of the central nervous system with potential to impact auditory pathways (i.e. major head trauma, meningitis, encephalitis, brain metastasis, vestibular schwannoma)
* Recent steroid treatment within the last month

Primary outcomes:
measure: Change in score of pure tone audiometry of conventional and high-frequency ranges (hearing level decibels [dB] hearing level)
timeFrame: Baseline to up to 3 months after completion of cisplatin treatment
Secondary outcomes:
measure: Change in score of distortion product otoacoustic emissions of conventional and high-frequency ranges (amplitude dB sound pressure level)
timeFrame: Baseline to up to 3 months after completion of cisplatin treatment
measure: Presence of ototoxicity as defined by the American Speech-Language Hearing Association (ASHA)
timeFrame: Up to 3 months after completion of cisplatin treatment
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Aaron Moberly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05654168: Muscular Morphological Ultrasound Epidemiological Study in Dance Professionals
Official title: Muscular Morphological Ultrasound Epidemiological Study in Dance Professionals
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Femoracetabular Impingement
Keywords: Dancing
Groin
Pain
Ultrasonography
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: • Professional dancers of the National Ballet of Spain

Brief summary: This research will determine the presence of groin pain in professional dancers, through a specific questionnaire on the hip joint. Two groups will be formed made up of dancers over 18 years of age, men and women; one with groin pain and one without groin pain. All participants will undergo a functional muscle ultrasound study, where the thickness of the abdominal muscles, lumbar multifidus and gluteus medius and minor will be evaluated, and the relationship between ultrasound neuromuscular changes and groin pain will be verified

Detailed description: The objective of the study is to shed light on the to the complexity of the Diagnosis that Groin Pain (GP) encloses, it is proposed to evaluate with Functional Muscular Ultrasonography Rehabilitative Ultrasound Imaging (RUSI), the layer thickness of the gluteal musculature of the hip and the abdominal and lumbar muscles on a sample of professional dancers over 18 years of age with GP to check if there are differences with professional dancers without GP.

Expected goals:

1. Identify the presence of GP in professional dancers.
2. To compare the ultrasound characteristics of the neuromuscular system between a sample of dancers with GP and a sample of dancers no GP.
3. Verify the relationship between ultrasound neuromuscular changes with GP.

Eligibility criteria: Inclusion Criteria:

* Volunteer Professional dancers 18 years or older, and no maximum age limits

Exclusion Criteria:

* Not signing the informed consent

Primary outcomes:
measure: RUSI. (REHABILITATIVE ULTRASOUND IMAGING)
timeFrame: Five months
Secondary outcomes:
measure: HAGOS questionnaire
timeFrame: Five months
Other outcomes:
measure: One- Way ANCOVA
timeFrame: Five months
Locations:
city: Madrid
country: Spain
facility: Miguel Angel Alcocer Ojeda
Study officials:
affiliation: Universidad de Murcia
name: MIGUEL ANGEL ALCOCER OJEDA, MSc PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Murcia
name: ANTONIA GOMEZ CONESA, PhD, PT
role: STUDY_DIRECTOR
References:
Clinical trial NCT05022368: Oral Device Clinical Trial
Official title: Surgical Safety Device Use During Transoral Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Tonsil Disease
Dental Diseases
Adenoid; Disorder (and Tonsils)
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Zotarix LLC
First posted: 2021-08-26
Enrollment: 250
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigators are studying the use of a new medical device developed at Nationwide Children's. This technology has been licensed and produced by Zotarix LLC, a medical device company. It is designed to aid in retraction and provide protection of the lips during surgery. The investigators are not recording any of your identifiable personal health information except for the surgery date. This device, called the LabraGuard is a sterile, soft medical grade silicone, and no alternative device with these exact protective properties exists, and the investigators are trying to learn more about how it performs in different age children.


Eligibility criteria: Inclusion Criteria:

* Subjects 21 years of age and under
* Having a surgical procedure done through the mouth where the lips are at risk of injury
* Performed by attendings from either the Otolaryngology department or the Dental department.
* Subject/Subject's guardian provides consent to be in the study

Exclusion Criteria:

* Allergy to silicone
* Unable to achieve good fit

Primary outcomes:
measure: Surgical Field Visibility
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT04757168: Changes in Regional and Global Cardiac Contractility After Stimulation in Scar Zone with the NOGA System
Official title: Changes in Regional and Global Cardiac Contractility After Stimulation in Scar Zone with the NOGA System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Keywords: stimulation in cardiac scar area
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Despite a decrease in voltage amplitude in post-infarction scar areas, greater voltage amplitudes are sometimes observed at the time of local extrasystoles mechanically induced by catheters.

However, no study has investigated whether these electrical changes are associated with mechanical changes in local contractility.

However, the voltage is closely correlated to the local contractile function as evidenced by the use of the NOGA system.


Eligibility criteria: Inclusion Criteria:

- Patients who should undergo ventricular tachycardia (VT) ablation after a myocardial infarction according to current recommendations, namely: patients with ischemic heart disease (ICD) and with episodes of sustained ventricular tachycardia responsible for internal electric shocks by the implantable automatic defibrillator (ICD) (grade IB recommendation)

OR

* patients with an MIC and an ICD, presenting a first episode of sustained ventricular tachycardia (grade IIa, B recommendation)
* Affiliated with a social protection scheme
* Having signed an informed consent

Exclusion Criteria:

* Contraindication or non-indication for ventricular tachycardia ablation
* Women who are pregnant or of childbearing age and without contraception, breastfeeding women
* Patients without ischemic heart disease
* Patients under guardianship, curatorship or legal protection.

Primary outcomes:
measure: Evolution of LLS (linear local shortening) via the NOGATM system in percentage
timeFrame: 1month
Secondary outcomes:
measure: Evolution of global systolic function: left ventricular ejection fraction
timeFrame: 1month
measure: Evolution of the global systolic function: integral time velocity under aortic Translation results Evolution of the global systolic function: integral time velocity under aortic
timeFrame: 1month
measure: Evolution of the global systolic function: strain longitudinal global
timeFrame: 1month
Other outcomes:
Locations:
city: Toulouse Cedex 9
country: France
facility: ROLLIN Anne
state: CHU de Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Anne ROLLIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06356168: Virtual Reality in End Stage Kidney Disease
Official title: Social Virtual Reality to Alleviate Loneliness and Symptoms for Individuals Receiving Hemodialysis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: End Stage Kidney Disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial to compare the social virtual reality and individual virtual reality in patients with end stage kidney disease who are hemodialysis. The main aim is to determine if there are differences in symptoms between the groups. Participants will use virtual reality glasses for 30-45 minutes during dialysis sessions for 4 weeks.

Detailed description: In a single site, 2-arm (Social Virtual Reality group; Individual Virtual Reality Group), parallel, randomized controlled trial we will enroll 60 subjects (n=30 per group) to assess the effects of Social Virtual Reality to Individual Virtual Reality on symptoms in participants with end stage kidney disease who are receiving hemodialysis.

To compare the effects of social virtual reality to individual virtual reality on loneliness To explore the effects of social virtual reality to individual virtual reality on anxiety and depression.

To compare the effects social virtual reality to individual virtual reality on quality of life.

Eligibility criteria: Inclusion Criteria

* Diagnosis of end stage kidney disease with hemodialysis 3 times per week for at least 1 month

Exclusion Criteria

* Acutely ill
* Active nausea
* Epilepsy

Primary outcomes:
measure: De Jong Gierveld Scale
timeFrame: Baseline and 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Lea Ann Matura, PhD
role: PRINCIPAL_INVESTIGATOR
References: