louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01308515: Vanguard Knee Anterior Stabilized Versus Posterior Stabilized Bearing Study
Official title: A Comparative Clinical Evaluation of the Vanguard Knee System's Anterior Stabilized & Posterior Stabilized Tibial Bearings
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoarthritis
Degenerative Arthritis
Keywords: knee
osteoarthritis
joint
replacement
knee surgery
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2011-03-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the performance of two FDA-cleared tibial bearings (replacement for cartilage in the knee) by collecting data on patients through 3 years of follow-up.


Eligibility criteria: Inclusion Criteria are identical to the indications stated in the FDA approved labeling for the device 510(k) K023546, K033489, and K050222. These indications are stated below:

* Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
* Correction of varus, valgus, or posttraumatic deformity.
* Correction or revision of unsuccessful osteotomy, or arthrodesis.

Patient selection factors to be considered include:

* Need to obtain pain relief and improve function
* Ability and willingness of the patient to follow instructions, including control of weight and activity level
* A good nutritional state of the patient
* The patient must have reached full skeletal maturity

Exclusion criteria will be identical to the contraindications stated in the FDA approved labeling for the device 510(k) K023546, K033489, and K050222.

These contraindications are stated below:

-Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement.

Relative contraindications include:

* Uncooperative patient or patient with neurologic disorders who are incapable of following directions
* Osteoporosis,
* Metabolic disorders which may impair bone formation
* Osteomalacia
* Distant foci of infections which may spread to the implant site,
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
* Vascular insufficiency, muscular atrophy, neuromuscular disease,
* Incomplete or deficient soft tissue surrounding the knee

Primary outcomes:
measure: Objective Knee Score
timeFrame: 1 Year Post-op
Secondary outcomes:
measure: Knee Society Score
timeFrame: 3 Years
measure: Dislocation
timeFrame: 3 Years
measure: Survivorship
timeFrame: 3 Years
measure: Reports of Radiographic Loosening via Complication Form
timeFrame: 3 Years
Other outcomes:
Locations:
Study officials:
affiliation: Biomet (no investigators were selected for this study)
name: Ken Beres, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00800215: A Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927
Official title: A Multicenter, Double-blind, Double-dummy, Randomized Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures With or Without Secondary Generalization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Keywords: Epilepsy
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-12-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial was to evaluate the safety and tolerability of SPM 927 when given as iv infusions compared with oral administration of the same dose strengths in subjects who were receiving oral SPM 927 for partial seizures with or without secondary generalization.

Trial procedures will include medical history update, physical/ neurological exams, ECGs, blood /urine sample collections and seizure diary completion.

Subjects completing the trial will return to the OLE trial to resume dosing with oral SPM 927.


Eligibility criteria: Inclusion Criteria:

* Subject with partial seizures with or without secondary generalization

Exclusion Criteria:

* Subject had previously received iv SPM 927
* Subject met the withdrawal criteria for the open-label extension trial with SPM 927 or was experiencing an ongoing serious adverse event.

Primary outcomes:
measure: Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination
timeFrame: 2 Days
Secondary outcomes:
measure: Seizure counts
timeFrame: 2 days
Other outcomes:
Locations:
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Biton V, Rosenfeld WE, Whitesides J, Fountain NB, Vaiciene N, Rudd GD. Intravenous lacosamide as replacement for oral lacosamide in patients with partial-onset seizures. Epilepsia. 2008 Mar;49(3):418-24. doi: 10.1111/j.1528-1167.2007.01317.x. Epub 2007 Sep 19.
Clinical trial NCT01624415: Subjective Image Quality in Stereoscopic Image Modifications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stereoscopic Vision
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-06-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants will be selected by the Department of Clinical Pharmacology healthy subjects, male and female, 18-35 years

Brief summary: Humans attain binocular vision from the two retinal images of both eyes through a series of sensory and motor processes that culminate in the perception of stereoscopic depth. Looking at a scene creates two slightly different images on the retinas which is due to the eyes' different positions on the head. This so called binocular disparity provides information to calculate depth and therefore enables stereopsis. Physiologically the two retinal images are superimposed and merge into one stereoscopic image.

If one image is presented to one eye in an experimental setting, and a completely different image is presented to the other eye, the investigators visual system, analogous to diplopic vision, is not able to fuse these image stimuli. Instead, a phenomenon called binocular rivalry occurs. Here, both images are seen alternating and the brain can switch back and forth between these images.

The aim of the present study is to investigate the effects of objective changes to image quality on the investigators subjective stereoscopic perception. This psychophysiological testing is done by looking at different images and thereafter by subjective grading of the image quality.

The investigators hypothesize that overlapping image modifications occurring in both eyes are detected immediately, but changes, that are rotated by 90 degrees against each other, should be suppressed and result in one stereoscopic image, reduced in image quality. Whether this also accounts for more detailed images, such as reading cards, is questionable.


Eligibility criteria: Inclusion Criteria:

* Men and women aged between 18 and 35 years, nonsmokers
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, emmetropia or ≤ 1 diopter

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug (except oral contraceptives)
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
References:
Clinical trial NCT04376515: HOPE Intervention for COVID-19
Official title: Harnessing Online Peer Education Online Support Intervention for COVID-19 (HOPE COVID-19)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Vaccination
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Harnessing Online Peer Education COVID-19 (HOPE COVID-19) intervention will assess whether a peer-led online support community can improve behavioral health outcomes related to COVID-19.

Detailed description: The Harnessing Online Peer Education COVID-19 (HOPE COVID-19) intervention will assess whether a peer-led online support community can improve behavioral health outcomes related to COVID-19. Participants in the intervention group will be assigned to peer leaders trained in the HOPE intervention methods.

Eligibility criteria: Inclusion Criteria:

1. 18-30 years old
2. English speakers only
3. U.S. Resident
4. Part of phase 1a or 1b of COVID-19 vaccine rollout (Healthcare personnel, education, and frontline essential workers, verified through LinkedIn profile)
5. Uses social media and/or online communities greater than twice per week
6. Has, or is willing to accept a friend request and group invite from our Facebook social media page
7. Have not received a COVID-19 vaccine and do not have medical conditions or other circumstances preventing them from receiving one

Exclusion Criteria:

-

Primary outcomes:
measure: Requests for a COVID-19 Vaccine Resource Sheet
timeFrame: 1 time request during the 4-week study
Secondary outcomes:
measure: Proof of COVID-19 Vaccination
timeFrame: 1 time proof during 4-week study and up to 2 weeks after
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UC Irvine
state: California
Study officials:
References:
Clinical trial NCT00259415: Telesupport: Evaluation of Professionally Led Support Groups for Caregivers
Official title: Evaluation of Professionally Led Support Groups for Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Caregiver Burden
Keywords: Support groups
Alzheimer's Disease
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2005-11-29
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study is a collaborative effort between a community-based service organization, Supportive Older Women's Network (SOWN), and an academic research division at Thomas Jefferson University (TJU). We plan to use a randomized controlled two-group design to: 1) test the effectiveness of the intervention at 6 months to enhance social support and perceived efficacy in comparison to a control group; 2) test if gains are sustained over 12 months (within experimental group comparison); and 3) evaluate the cost and cost effectiveness of the intervention. Three secondary study aims are to describe the process and content of tele-support groups (dose/intensity, support group topics); evaluate the relative benefits for African American and White females; and determine if control group subjects benefit from receiving a peer's telephone number for mutual support (within group comparison between 6 and 12 months).


Eligibility criteria: Inclusion Criteria:

* Caregivers will be recruited for study participation who fit the following criteria: 1) female, 2) 55 or older, 3) has been a caregiver for a minimum of 6 months, 3) provides care to a person with a physician's diagnosis of ADRD, 4) has weekly access to a telephone for one hour without interruption during working hours, or if unable to have uninterrupted time, willing to have home-maker service. Homemaker service during the tele-group meetings will be arranged by the recruitment source. For this study, we plan to recruit only females since they represent the majority of those providing care to persons with ADRD and have been shown to demonstrate significantly more stress and negative health outcomes than male caregivers.

Exclusion Criteria:

* Male
* under age of 55
* not a caregiver of person with ADRD

Primary outcomes:
measure: Caregiver depression
measure: Caregiver burdern
measure: Caregiver social support
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson
name: Laura N Gitlin, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03881852: Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, 3-Week Crossover Study to Assess the Efficacy and Safety of AXS-12 in Subjects With Cataplexy and Excessive Daytime Sleepiness in Narcolepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Narcolepsy
Cataplexy Narcolepsy
Excessive Sleepiness
Keywords: CONCERT
AXS-12
EDS
Cataplexy
Narcolepsy
Axsome
Reboxetine
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-20
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter trial of AXS-12 in patients with narcolepsy. Subjects meeting the entry criteria will be randomized in a 1:1 ratio either to placebo for three weeks followed by AXS-12 (up to 10 mg daily) for three weeks, or to AXS-12 (up to 10 mg daily) for three weeks followed by placebo for three weeks. Efficacy assessments will include the frequency of cataplexy attacks, and measures of other symptoms of narcolepsy.


Eligibility criteria: Key Inclusion Criteria:

* Male or female subjects between 18 and 70 years of age, inclusive
* Primary diagnosis of narcolepsy with cataplexy
* Willing and able to comply with the study requirements

Exclusion Criteria:

* Other clinically significant conditions potentially causing EDS
* Clinically significant psychiatric disorders

Primary outcomes:
measure: Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: CONCERT Study Site
state: Alabama
city: Alameda
country: United States
facility: CONCERT Study Site
state: California
city: Santa Ana
country: United States
facility: CONCERT Study Site
state: California
city: Boulder
country: United States
facility: CONCERT Study Site
state: Colorado
city: Miami
country: United States
facility: CONCERT Study Site
state: Florida
city: Saint Petersburg
country: United States
facility: CONCERT Study Site
state: Florida
city: Gainesville
country: United States
facility: CONCERT Study Site
state: Georgia
city: Fort Wayne
country: United States
facility: CONCERT Study Site
state: Indiana
city: Chevy Chase
country: United States
facility: CONCERT Study Site
state: Maryland
city: Bronx
country: United States
facility: CONCERT Study Site
state: New York
city: Cincinnati
country: United States
facility: CONCERT Study Site
state: Ohio
city: Columbia
country: United States
facility: CONCERT Study Site
state: South Carolina
city: Austin
country: United States
facility: CONCERT Study Site
state: Texas
city: San Antonio
country: United States
facility: CONCERT Study Site
state: Texas
Study officials:
References:
Clinical trial NCT05834452: Treatment of Posterior Benign Paroxysmal Positional Vertigo With Mechanical Rotational Chair.
Official title: Treatment of Posterior Benign Paroxysmal Positional Vertigo With Mechanical Rotational Chair: A Randomized Controlled Trial Comparing Epley and 360° Maneuvers.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Paroxysmal Positional Vertigo
BPPV
Keywords: Benign Paroxysmal Positional Vertigo
Vertigo
Dizziness
Vestibular Diseases
Epley Maneuver
TRV chair
Mechanical Rotational Chair
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of treatment efficacy of Epley maneuver and 360 maneuver in a mechanical rotational chair (TRV chair) in patient with posterior benign paroxysmal positional vertigo (BPPV).

Detailed description: Open-label, randomized controlled trial comparing the Epley maneuver with the 360 maneuver using the TRV chair in both scenarios. Patients diagnosed with posterior BPPV will be randomized to receive treatment with either the Epley maneuver or the 360 maneuver.

Eligibility criteria: Inclusion Criteria:

* Age above 18 years
* Confirmed unilateral p-BPPV (canalithiasis and cupulolithiasis)
* Understand written and spoken Danish

Exclusion Criteria:

* Pregnancy
* Weight ≥ 150 kg and or Height ≥ 2m
* Not possible to attend follow-up visits
* Insufficient cooperation during diagnostic testing or treatment in the mechanical rotational chair
* Have received treatment for BPPV in a mechanical rotational chair within the last 6 months
* Sedative antihistamines are taken within the past 7 days
* Comorbidities: Heart failure (EF\<40), known cerebral aneurysm, cerebrovascular events (\<3 months), and dissection disease
* Spontaneous or gaze evoked nystagmus.

Primary outcomes:
measure: Treatment success after first treatment
timeFrame: 2 year
measure: Number of treatments
timeFrame: 2 year
Secondary outcomes:
measure: Dizziness Handicap Inventory (DHI) Questionnaire
timeFrame: 2 year
measure: Adverse events
timeFrame: 2 year
measure: Recurrence rate
timeFrame: 2 year
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: epartment of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital
state: North Denmark Region
Study officials:
affiliation: Department of Otolaryngology, Head & Neck Surgery and Audiology
name: Malene Hentze Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01704352: Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder
Official title: Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Insomnia
Keywords: Cognitive Behavioral Therapy
CBT-I
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2012-10-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with bipolar disorder suffer from sleep disturbances, even in euthymic phases. Changes in sleep are frequent signs of a new episode of (hypo)mania or depression. Cognitive behavioral therapy for insomnia is an effective treatment for primary insomnia, but has not been introduced to patients with bipolar disorder. The aim is to compare cognitive behavioral therapy added to 'treatment as usual' with just 'treatment as usual'. The investigators hypothesize that cognitive behavioral therapy will improve quality of sleep, stabilize minor mood variations and prevent new mood episodes in euthymic patients with bipolar disorder and insomnia.


Eligibility criteria: Inclusion Criteria:

* Fulfilling criteria for SCID-1-verified bipolar I or II disorder
* Euthymic, as defined by Montgomery Åsberg Depression Rating Scale (MADRS) not higher than eleven, and Young Mania Rating scale (YMRS) not higher than five.
* Fulfilling DSM-IV criteria for primary insomnia or insomnia related to another mental disorder, as assessed by the Insomnia Interview Schedule (IIS).

Exclusion Criteria:

* Being or having been in a defined affective episode the last month before inclusion
* Hospitalization in the last two months before inclusion
* Working night shifts
* Sleep apnea
* Medical conditions incompatible with participation.
* Inability to cooperate in the 3-week initial phase before randomization.

Primary outcomes:
measure: Change from baseline in quality of sleep at 8 weeks
timeFrame: At 8 weeks from randomization
measure: Change from baseline in quality of sleep at 6 months follow-up
timeFrame: 6 months from end of treatment phase
Secondary outcomes:
measure: Variation in sleep registration from baseline to 8 weeks
timeFrame: At 8 weeks
measure: Variation in sleep registration from baseline to 6 months follow-up
timeFrame: At 6 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Østmarka Psychiatric Department, St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Gunnar Morken, PhD Prof
role: STUDY_DIRECTOR
References:
citation: Steinan MK, Krane-Gartiser K, Langsrud K, Sand T, Kallestad H, Morken G. Cognitive behavioral therapy for insomnia in euthymic bipolar disorder: study protocol for a randomized controlled trial. Trials. 2014 Jan 16;15:24. doi: 10.1186/1745-6215-15-24.
Clinical trial NCT03445832: Pulmonary Function and Neuromuscular Disease
Official title: Pulmonary Function and Neuromuscular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Diseases
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 21
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children suffering from neuromuscular diseases and followed-up in Besançon University Hospital between 2006/01/01 and the beginning of this study

Brief summary: This study aims to describe the evolution of pulmonary function in 3 neuromuscular diseases : Duchenne muscular dystrophy, Werdnig-Hoffinann disease, congenital myopathy, monitored in Besançon university hospital.


Eligibility criteria: Inclusion Criteria:

* Neuromuscular disease
* Followed-up in Besançon University Hospital
* With at least 2 Pulmonary Function Tests previously performed

Exclusion Criteria:

* Mental deficiency
* Facial expressions disorders

Primary outcomes:
measure: FVC (Forced Vital Capacity)
timeFrame: Year 12
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
References: