louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05364983: Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens
Official title: A Prospective, Randomized, Controlled, Double-Masked, Phased, Multi-Center Clinical Study to Evaluate the Safety and Efficacy of the LensGen® Juvene® Intraocular Lens
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cataract
Presbyopia
Lead sponsor: LensGen, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-06
Enrollment: 56
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A prospective, randomized, controlled, double-masked, phased, multicenter clinical study
Primary purpose: TREATMENT

Brief summary: To assess the safety and effectiveness of the Juvene® IOL for the treatment of aphakia and mitigation of the effects of presbyopia after removal of the natural crystalline lens due to cataract.


Eligibility criteria: Key Inclusion Criteria:

* Subjects must be 22 years of age or older
* Able to comprehend and provide written informed consent
* Willing and able to comply with schedule for follow-up visits
* Demonstrate sufficient cognitive awareness to comply with examination procedures
* Other inclusion criteria specified in the protocol may apply.

Key Exclusion Criteria:

* Subjects with clinically significant dry eye syndrome (DES) expected to impact postoperative visual acuity
* Subjects taking medications that may affect ocular function (including but not limited to mydriatic, cycloplegic and miotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, and anticholinergic agents)
* Prior intraocular or corneal surgery (including corneal refractive correction i.e., LASIK, PRK, etc.)
* Any corneal dystrophy that may affect visual acuity (e.g., keratoconus, pellucid corneal degeneration, etc.)
* Other exclusion criteria specified in the protocol may apply.

Primary outcomes:
measure: Distance-corrected intermediate ETDRS LogMar visual acuity
timeFrame: 12 Months
measure: Distance-corrected intermediate ETDRS LogMar visual acuity vs Control
timeFrame: 12 Months
measure: Defocus curve testing with ETDRS chart
timeFrame: 12 Months
measure: Best corrected distance ETDRS LogMar visual acuity vs control
timeFrame: 12 Months
measure: Best corrected distance ETDRS LogMar visual acuity
timeFrame: 12 Months
Secondary outcomes:
measure: Distance-corrected near ETDRS LogMar visual acuity
timeFrame: 12 Months
measure: Distance-corrected near ETDRS LogMar visual acuity vs control
timeFrame: 12 Months
Other outcomes:
Locations:
Study officials:
affiliation: LensGen, Inc.
name: Patrick R Casey, O.D.
role: STUDY_DIRECTOR
References:
citation: Garg S, De Jesus MT, Fletcher LM, Chayet A, Barragan E, Casey P. Twelve-month clinical outcomes after implantation of a new, modular, anterior shape-changing fluid optic intraocular lens. J Cataract Refract Surg. 2022 Oct 1;48(10):1134-1140. doi: 10.1097/j.jcrs.0000000000000935.
Clinical trial NCT01698983: Ex Vivo Stimulation of Whole Blood as a Means to Determine Glucocorticoid Sensitivity to Mild-to-Moderate and Refractory Asthmatics
Official title: Ex Vivo Stimulation of Whole Blood as a Means to Determine Glucocorticoid Sensitivity to Mild-to-Moderate and Refractory Asthmatics
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Asthma
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 14
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: clinic

Brief summary: Gluococorticoids are commonly prescribed to treat a number of diseases including the majority of inflammatory diseases. Despite considerable inter-personal variability in responses to glucocorticoids between asthmatics, an insensitivity rate of about 30% and the risk of adverse side effects of glucocorticoid therapy, no assay is currently performed to determine sensitivity in severe and non-severe asthmatics prior to treatment. The purpose of this study is to perform a whole blood ex vivo stimulation assay to interrogate known glucocorticoid receptor (GR) up- and down-regulated genes to indicate glucocorticoid sensitivity and compare the results between severe and non-severe asthmatics.


Eligibility criteria: Inclusion criteria:

To be eligible for the study, subjects must meet all of the following criteria:

* Age ≥ 18 years old
* Physician diagnosis of asthma confirmed through medical record documentation.
* Documented history of 12% FEV1 reversibility post-bronchodilator and/or Methacholine PC 20 score of 16mg/ml or less.
* Non-smoker for \> 6 months before enrollment into the trial
* Less than 5 pack year smoking history defined as the average packs smoked per day multiplied by the years of active smoking.
* Willing and able to adhere to the study visit schedule and other protocol-specified procedures.

Exclusion criteria:

Subjects meeting any of the following criteria may not be enrolled in the study:

* Existence of lung disease (other than asthma)
* Recent asthma exacerbation requiring hospital admissions, unexpected healthcare visits, or prednisone courses in the previous 4 weeks.
* Non-English speaking.
* Participation in another interventional research trial
* Self-reported pregnancy
* Inability or unwillingness to provide consent
* Febrile illness (\>38.0˚ C or 100.4˚ F) within 24 hours of visit.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Martha Morehouse Medical Pavillion
state: Ohio
city: Columbus
country: United States
facility: Martha Morehouse Medical Pavillion
state: Ohio
Study officials:
affiliation: Recruit and Consent Patients
name: Jeanette Marketon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01224483: Multicenter Retrospective Analysis About the Clinical Characteristics of Korean Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients
Official title: Multicenter Retrospective Analysis About the Clinical Characteristics of Korean Patients With PNH
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemoglobinuria, Paroxysmal
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-10-20
Enrollment: 350
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Korean PNH patients: diagnosis confirmed by Ham's test or Flow cytometry

Brief summary: Paroxysmal nocturnal hemoglobinuria (PNH) is a hematopoietic stem cell disorder in which unregulated activation of the complement system leads to significant ischemic morbidities with shortened lifespan. Life-threatening thromboembolism (TE) is the most feared complication of PNH, accounting for up to 45% of patient deaths. It is estimated that 40% of PNH patients experience a clinically evident TE and 60% of patients without clinically diagnosed TE demonstrate TE by high-sensitivity MRI, indicating the ongoing thrombotic risk in most patients with PNH. Much of these data come from PNH patients from European descent. To understand the impact of TE in patients with PNH from non-European regions, we performed this study to evaluate the clinical characteristics of Korean patients with PNH.

Detailed description: To evaluate the clinical characteristics in Korean PNH patients

Eligibility criteria: Inclusion Criteria:

* Diagnosis confirmed by Ham's test or Flow cytometry Patients have any Flow cytometry data

Exclusion Criteria:

* Patients have no Flow cytometry data

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Hematology Oncology, Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jun Ho Jang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jang JH, Kim JS, Yoon SS, Lee JH, Kim YK, Jo DY, Chung J, Sohn SK, Lee JW. Predictive Factors of Mortality in Population of Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH): Results from a Korean PNH Registry. J Korean Med Sci. 2016 Feb;31(2):214-21. doi: 10.3346/jkms.2016.31.2.214. Epub 2016 Jan 26.
citation: Kim JS, Jang JH, Yoon SS, Lee JH, Kim YK, Jo DY, Chung JS, Sohn SK, Lee JW. Distinct subgroups of paroxysmal nocturnal hemoglobinuria (PNH) with cytopenia: results from South Korean National PNH Registry. Ann Hematol. 2016 Jan;95(1):125-133. doi: 10.1007/s00277-015-2511-z. Epub 2015 Sep 29.
citation: Lee JW, Jang JH, Kim JS, Yoon SS, Lee JH, Kim YK, Jo DY, Chung J, Sohn SK. Clinical signs and symptoms associated with increased risk for thrombosis in patients with paroxysmal nocturnal hemoglobinuria from a Korean Registry. Int J Hematol. 2013 Jun;97(6):749-57. doi: 10.1007/s12185-013-1346-4. Epub 2013 May 1.
Clinical trial NCT03108183: Apicoectomy Longterm Results
Official title: A Prospective Study to Evaluate the Longterm Treatment Results After Micro-surgical Root Resection of Teeth With Post and Core and Crown
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periapical Diseases
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 73
Sex: ALL
Minimum age (years): 27
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 73 patients, who have been treated with apicoectomy on teeth with post and core and crown between the years 2004 and 2006 and who have already been followed up in 2008, will be followed up once more in 2017.

Brief summary: The purpose of the study is to evaluate the longterm treatment results after micro-surgical root resection of teeth with post and core and crown.

Detailed description: All 73 patients, who have been treated with apicoectomy on teeth with post and core and crown between the years 2004 and 2006 and who have already been followed up in 2008, will be followed up once more in 2017.

The patients will have a clinical and radiologic examination. The investigators will examine if new periapical lesions, bone loss, fracture of teeth or loss of teeth exist.

Eligibility criteria: Inclusion Criteria:

* All 73 patients, who were treated with apicoectomy on teeth with post and core and crown between the years 2004 and 2006 and who have already been followed up in 2008, will be followed up once more in 2017.

Exclusion Criteria:

* Pregnancy
* Patients who do not want to participate in clinical and radiological follow up.

Primary outcomes:
measure: Appearance of periapical lesions on tooth after root resection
timeFrame: 1 day
measure: Size of periapical lesions on tooth after root resection
timeFrame: 1 day
Secondary outcomes:
measure: Vertical and horizontal bone loss on the tooth after root resection
timeFrame: 1 day
measure: Occurrence of tooth fractures
timeFrame: 1 day
measure: Occurrence of tooth loss
timeFrame: 1 day
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University
Study officials:
affiliation: Department of dental medicine and oral health, Medical University of Graz
name: Norbert Jakse, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Molven O, Halse A, Grung B. Observer strategy and the radiographic classification of healing after endodontic surgery. Int J Oral Maxillofac Surg. 1987 Aug;16(4):432-9. doi: 10.1016/s0901-5027(87)80080-2.
Clinical trial NCT00668083: Observational Retrospective Trial on Sequential Hormonal Therapy in Patients With Prostate Cancer
Official title: Observational Retrospective Trial on Sequential Hormonal Therapy in Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: second line
Prostate Cancer
bicalutamide
biochemical relapse/progression in patients with Prostate Cancer treated with bicalutamide 150mg
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-28
Enrollment: 214
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: THIS IS A RETROSPECTIVE TRIAL THEREFORE CLINICAL DATA ARE FROM ARCHIVED CLINICAL RECORD OF PATIENTS WHO WERE ADMITTED IN THE HOSPITAL.

Brief summary: Observational Retrospective trial on sequential hormonal therapy in patients with Prostate Cancer


Eligibility criteria: Inclusion Criteria:

* non metastatic Prostate Cancer
* previous treatment with bicalutamide 150mg
* biochemical relapse/progression

Exclusion Criteria:

* use of other treatments for Prostate Cancer

Primary outcomes:
measure: Hormonal sensitivity to second line treatment for CaP after Bicalutamide
timeFrame: six months
Secondary outcomes:
measure: median duration of second and third line treatments;
timeFrame: six months
Other outcomes:
Locations:
city: Acquaviva delle Fonti
country: Italy
facility: Research Site
city: Ancona
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research SIte
city: Matera
country: Italy
facility: Research Site
city: Messina
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Monza
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Portogruaro
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Viareggio
country: Italy
facility: Research Site
Study officials:
affiliation: AstraZeneca Medical Dept
name: Davide Meani, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00956683: Dual Endpoint Nerve Stimulation Versus Ultrasound in Infraclavicular Block for Hand Surgery
Official title: A Randomized Controlled Study Comparing Dual Endpoint Nerve Stimulation With Ultrasound-guided Infraclavicular Block for Hand Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Surgery
Keywords: infraclavicular nerve block ultrasound dual endpoint stimulation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Current best practice for performance of infraclavicular block dictates the use of a dual-endpoint nerve stimulation technique that still only results in a 79% success rate. Use of an ultrasound-guided technique has the potential to significantly improve success. A randomized, controlled study to evaluate this area remains to be performed and is required to demonstrate to anesthesiologists that an ultrasound-guided approach should supersede nerve stimulation as the technique of choice for infraclavicular block.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective upper limb surgery at or below the elbow.
* Patients aged \>18 and \<80 years
* ASA I-III
* BMI\<35

Exclusion Criteria:

* Inability to read, write or speak English. (This is necessary because subjects will have to follow detailed instructions to allow testing of motor and sensory function. It is not feasible to have an interpreter present in the block room during performance of these procedures)
* Contraindication to brachial plexus block
* Existing neurological deficit in the area to be blocked
* Known loco-regional malignancy or infection
* Coagulopathy
* Allergy to local anesthetic agents.
* Chest or shoulder deformities
* Severe respiratory disease
* Healed but dislocated clavicle fracture

Primary outcomes:
measure: To compare ultrasound-guided infraclavicular block with conventional dual-endpoint nerve stimulator guided infraclavicular block with regards to block success, ease of nerve localization, speed of onset, duration of block and complications.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Colin McCartney
state: Ontario
Study officials:
References:
Clinical trial NCT05838183: Interstitial Lung Disease and Obstructive Sleep Apnea
Official title: Study on the Clinical Characteristics of Interstitial Lung Disease and Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ILD OSA
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Interstitial lung disease and respiratory sleep apnoea

Brief summary: Clinically, all patients with interstitial lung disease(ILD) were observed, and relevant clinical data were collected. Bronchoscopic specimens were collected according to the condition of the enrolled patients, and the rapid on site evaluation(ROSE) was evaluated, combined with the metagenomic next generation sequencing(mNGS) results of these patients. To observe the etiology and biological characteristics of exacerbation in patients with interstitial lung disease.

All patients undergo polysomnography (PSG) and drug-induced sleep endoscopy(DISE). The biological specimens was obtained for molecular biology or other tests.We detected Claudin1, Claudin2, Claudin3, Claudin4, and IL22 as biomarkers to differentiate the diagnostic efficiency of OSA in ILD, ILD+OSA, OSA, and Ctrl groups, respectively


Eligibility criteria: Inclusion criteria:

* over 18 years old and under 80 years old.
* Clinical diagnosis of interstitial lung disease or obstructive respiratory sleep apnea syndrome.
* Patient is conscious and capable of signing informed consent.
* The patient may wear a polysomnograph.

Exclusion criteria:

* malignant tumors.
* severe heart failure.
* uremia.
* autoimmune diseases.
* pulmonary embolism, and end-stage chronic obstructive pulmonary disease.
* Patients with mental illnesscannot sign informed consent on their own.

Primary outcomes:
measure: imaging changes and ROSE and NGS in patients
timeFrame: 2Day
Secondary outcomes:
measure: Severity and biological examination of OSA patients
timeFrame: 2Day
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
Study officials:
References:
Clinical trial NCT06380283: The Feasibility and Clinical Utility of the Use of Virtual Reality for the Management of Pediatric Dental Anxiety
Official title: The Feasibility and Clinical Utility of the Use of Virtual Reality for the Management of Pediatric Dental Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Children, Only
Dental Anxiety
Behavior
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 128
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The use of virtual reality (VR) in pediatric healthcare settings helps to reduce children's pain and anxiety. However, this technology has not been used consistently in pediatric dentistry. Consequently, the goal of this study is to investigate the effectiveness of using a Virtual Reality headset as a distraction technique during dental procedures in children and identify patient and clinician's opinions regarding its use.

This study incorporates a single-site, randomized clinical trial design with two paralleled study groups. One group will receive dental treatment following regular standard of care of behavior management while the second group will receive dental treatment using a Virtual Reality distraction headset. Patients in both groups will complete a questionnaire to assess their perception of pain and anxiety before and after the intervention, as well as their satisfaction with the dental treatment. The dentist providing the treatment will also report their observations relating to patient behavior during dental treatment.


Eligibility criteria: Inclusion Criteria:

* Children aged between 6 and 12 years and their accompanying parent/legal-guardian.
* Children scheduled for one of the following procedures: restorative treatments (amalgam, composite or stainless-steel crowns), pulp therapy and extractions
* Children that can understand and speak French or English.

Exclusion Criteria:

* Children diagnosed with a cognitive, auditory, or cognitive impairment preventing them from interacting with the VR game.
* Children diagnosed with epilepsy or any other condition preventing them from playing the VR game.
* Children requiring urgent dental care
* Children requiring dental treatment with conscious sedation (i.e. nitrous oxide inhalation and/or oral sedation with benzodiazepines)

Primary outcomes:
measure: Children's pain perception during dental treatment
timeFrame: Baseline
measure: Children's fear during dental treatment
timeFrame: Baseline
Secondary outcomes:
measure: Children's acceptability of virtual reality intervention during dental care
timeFrame: Baseline
measure: Oral health care provider's acceptability of virtual reality during dental care
timeFrame: Baseline
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Division of Dentistry, Montreal Children's Hospital, McGill University Health Centre
state: Quebec
Study officials:
References:
Clinical trial NCT04783883: Electrical Vestibular Nerve Stimulation (VeNS): A Follow-up Assessment of Long-term Usage
Official title: Electrical Vestibular Nerve Stimulation (VeNS): A Follow-up Safety Assessment of Long-Term Usage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Safety Issues
Keywords: Neuromodulation
Safety
Vestibular
Lead sponsor: Neurovalens Ltd.
Sponsor class: INDUSTRY
Collaborators: name: R D Gardi Medical College, Ujjain
First posted: 2021-03-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Vestal DM device users from any country.

Brief summary: A follow-up assessment study of the long-term safety of vestibular electrical stimulation as delivered by the Vestal DM Device.

Detailed description: A retrospective, open-label, follow-up study assessing the long-term safety and efficacy of vestibular electrical stimulation as delivered by the Vestal DM Device.

Eligibility criteria: Inclusion Criteria:

* Vestal DM user (more than 6 months)

Exclusion Criteria:

* Vestal DM device user (less than 6 months)

Primary outcomes:
measure: Assessment of hearing function as reported by formal audiometry testing
timeFrame: Baseline
Secondary outcomes:
measure: Frequency of device related adverse events
timeFrame: Baseline
measure: Inspection of the skin behind the ears (mastoid area)
timeFrame: Baseline
measure: Otoscope examination of the inside of both ear canals and tympanic membranes
timeFrame: Baseline
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Neurovalens Ltd., 7 James St. South
Study officials:
References: