louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04146493: Heparin-Binding Protein and Heparins
Official title: Heparin-binding Protein and Heparins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Disease, Peripheral
Thromboprophylaxis
Cardiovascular Diseases
Keywords: Heparin-binding protein
Heparin
Biomarker
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2019-10-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A) Patients operated for peripheral vascular disease or aortic disease B) Patients operated for major surgery C) Patients operated for open heart surgery with cardiopulmonary bypass.

Brief summary: Heparin-Binding protein is a protein from primary and secretory granluae of white blood cells. It is released when white blood cells become activated and has been advocated as a biomarker for sepsis. The aim of this study is to find out if Heparins in clinical doses can change the level of Heparin-binding protein in plasma.

Detailed description: Blood samples are taken from patients before and after Heparins in clinical doses. The effects of heparins on Heparin-binding protein concentration in plasma is measured. This is a small observational study.

Eligibility criteria: Inclusion Criteria:

* Planned endovascular treatment of aortic aneurysm or peripheral vascular surgery where unfractionated heparin in \>3000 units are given perioperatively
* Planned subcutaneous low molecular weight heparin as a thromboprophylactic treatment after major surgery or on Intensive Care treated patients.
* Planned open heart surgery with cardiopulmonary bypass.

Exclusion Criteria:

* Under 18 years
* Unable to get informed consent from patient or relative

Primary outcomes:
measure: Changes in the level of Heparin-binding protein
timeFrame: Repeated blood sampling during minimum of 1 hour and maximum of 5 hours after given heparin
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Halla Halldorsdottir
state: Solna
Study officials:
affiliation: Karolinska Institutet
name: Halla Halldorsdottir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02382393: Reliability and Validity of Online Cognitive Assessments
Official title: Reliability and Validity of Online Cognitive Assessments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: cognitive assessment
Brain Performance Test
Lumosity
concurrent validity
computerized assessment
Lead sponsor: Lumos Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-06
Enrollment: 1152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate the concurrent validity (correlation coefficient of scores at 1 time point) between the Brain Performance Test (BPT, Lumos Labs, Inc.) and a validated third party computerized assessment.

Detailed description: Each subject will complete two sessions, each approximately 1 hour in total duration, approximately 2 weeks apart for a total duration of participation of 2 hours over 2 weeks

Eligibility criteria: Inclusion Criteria:

* Electronically signed informed consent
* 18 years of age or older
* Native English-Speaker
* Consistent access to a computer with stable internet connection

Exclusion Criteria:

* Under 18 years of age
* Native language other than English
* Visual impairment that impedes computer use
* Has taken a cognitive assessment or done cognitive training in the past year

Primary outcomes:
measure: BPT Grand Index Score at Time 1
timeFrame: Baseline
measure: Computerized Assessment Index at Time 1
timeFrame: Baseline
measure: Selected raw and scaled BPT and Computerized Assessment matched subtest scores at Time 1
timeFrame: Baseline
Secondary outcomes:
measure: BPT Grand Index at Time 1 and Time 2
timeFrame: Baseline to 2 weeks
measure: Computerized Assessment Index at Time 1 and Time 2
timeFrame: Baseline to 2 weeks
measure: Raw and scaled BPT subtest scores at Time 1 and Time 2
timeFrame: Baseline to 2 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Lumos Labs, Inc.
state: California
Study officials:
affiliation: Lumos Labs, Inc.
name: Glenn Morrison, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05157893: Effects of Virtual Reality (VR) Based Distraction and Relaxation Therapy on Moderate and Severe Pain
Official title: Effects of Virtual Reality (VR) Based Distraction and Relaxation Therapy on Moderate and Severe Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Keywords: pain
virtual reality
distraction therapy
relaxation therapy
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-arm, open, single-center clinical study. This study is a pilot study to explore the use of VR based distraction and relaxation therapy as an adjunctive analgesic method for Chinese patients with moderate to severe pain. After screening, patients with moderate to severe pain who meet the study inclusion criteria receive VR therapy for 15 minutes to evaluate the effectiveness and safety of VR therapy.


Eligibility criteria: Inclusion Criteria:

* Males and females ≥18 years old.
* Average pain intensity≥4 on a 0-10 numerical rating scale (NRS) in the past 24 hours.
* Be able to communicate in Chinese.
* Be able to read and write Chinese.
* Willing to comply with study procedures and restrictions.
* Willing and able to sign informed consent.

Exclusion Criteria:

* Shingles on the eyes, ears, head, face, or hands.
* Trigeminal neuralgia.
* Severe vision impairment. (Patients with clear vision wearing glasses or contact lenses are allowed)
* Severe hearing impairment.
* Disease or medical condition predisposing to nausea or dizziness, such as insufficient blood supply to the brain, vestibular dysfunction, cholecystitis, etc.
* History of severe motion sickness.
* Injury to eyes, ears, face, or neck that impedes comfortable use of virtual reality.
* Injury or dysfunction of hands or upper limbs that impedes comfortable use of virtual reality.
* Diagnosis of cognitive impairment, epilepsy, dementia, migraines or other neurological diseases that may prevent the use of virtual reality.
* History of mental illness, including depression, generalized anxiety disorder, schizophrenia, etc.
* Females currently pregnant.
* Current or completion of participation within 4 weeks before screening in any interventional clinical study
* Patients whom the investigator considers not suitable to participate in this study.

Primary outcomes:
measure: Change in pain intensity before and after VR therapy
timeFrame: 20min
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai XINHUA Hospital
Study officials:
References:
Clinical trial NCT02005393: Study Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI)
Official title: A Concurrence Study of Diagnostic Visualization Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Routine Endoscopy
Keywords: FICE
NBI
Lead sponsor: Fujifilm Medical Systems USA, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study is intended to test the image quality of the FICE system to the predicate device, Narrow Band Imaging (NBI). The hypothesis is the images are of equal quality.

Detailed description: No additional description required.

Eligibility criteria: Inclusion Criteria:

* Referred for diagnostic endoscopy or colonoscopy
* Ability to comply and willingness to partake in study

Exclusion Criteria:

* less than 21 years of age
* is an inmate

Primary outcomes:
measure: Image Quality Scores Using Likert Scale
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic, Arizona
state: Arizona
Study officials:
affiliation: FujiFilm Medical Systems USA
name: Mary Moore
role: STUDY_DIRECTOR
References:
Clinical trial NCT06154993: Comparison of Static and Dynamic Opening With Neural Sliding in Cervical Radiculopathy
Official title: Comparison of Static and Dynamic Opening With Neural Sliding in Cervical Radiculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical
Cervical Radiculopathy
Keywords: cervical radiculopathy
static opener
dynamic opener
slider neurodynamic
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 36
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled trial is to determine the effects of static and dynamic opening with neural sliding in patients with cervical radiculopathy for reducing pain, enhancing cervical range of motion and improve functional status.

Detailed description: Static opener is a neurodynamic technique for cervical radiculopathy for reducing pressure on the nervous system that causes intervertebral foramina to remain in the open position for a certain period. This enables blood flow to return to neural tissue so that oxygenation is improved, along with slider mobilization will reduce symptoms and give better healing to the inflamed nerve. when the intervertebral foramina remain open for a considerable amount of time axoplasmic flow is reestablished, oxygenation is improved, increases blood flow along with venous return and nerve gets more nutrients and all the inflammatory exudate is taken off resulting for early improvement.

Dynamic opener is a neurodynamic technique in opening direction to repetitively open and close the intervertebral foramina and produces oscillatory movements that cause pumping effect on the nerve and help to drain edema due to inflammation and help reduce pain and increase the range also.

Eligibility criteria: Inclusion Criteria:

* : • Spurling +ive

  * Distraction test +ive (alleviate symptoms)
  * Pain, paresthesia and numbness in Rt/Lt UL in dermatomal pattern of median nerve
  * MRI confirmed spondylosis or disc herniation
  * Age 35-60

Exclusion Criteria:

* • Cervical spine fracture

  * RA
  * Cervical myelopathy
  * Systemic neurological conditions
  * Osteoporosis

Primary outcomes:
measure: neck disability index
timeFrame: 4 weeks
measure: visual analogue scale
timeFrame: 4 weeks
measure: inclinometer
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: RehabWrox
state: Federal
city: Rawalpindi
country: Pakistan
facility: Pakistan Railway General Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Affan Iqbal, Phd*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00351793: A Clinical Trial Follow-up Study of the Genesis II Posterior Stabilized Total Knee Replacement
Official title: A Clinical Trial Follow-up Study of the Genesis II Posterior Stabilized Total Knee Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Nova Scotia Health Authority
First posted: 2006-07-13
Enrollment: 186
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Total knee replacement candidates

Brief summary: The purpose of this study is to look at the outcomes of the GENESIS II Posterior Stabilized Total Knee Replacement.


Eligibility criteria: Inclusion Criteria:

* A combined deformity of \<30 degrees = group 1
* A combined deformity of \>30 degrees = group 2
* Patient is willing to consent to participate in the study
* Patient is available for follow-up through at least 2 years but preferably 5 years
* Patient has met acceptable preoperative medical clearance and is free of or treated for medical conditions that would pose excessive operative risk
* Patients who are fluent in English and are able to understand their role in a clinical trial

Exclusion Criteria:

* Active, local infection or systemic infection
* Fibromyalgia patients
* Patients whom, as judged by the surgeon, are not capable of understanding the informed consent or the requirements of the protocol and or are reasonably unlikely to be compliant with the prescribed routine and the follow-up evaluation schedule

Primary outcomes:
measure: Effectiveness and Safety
timeFrame: 5 years
Secondary outcomes:
measure: Knee Society Clinical Rating
timeFrame: Pre-op, 6 months, 1 year, 2 years, 5 years
measure: Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Pre-op, 6 months, 1 year, 2 years, 5 years
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: Capital Health, Canada
name: Ross K Leighton, MD, FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00735293: VASER Treatment of Axillary Hyperhidrosis/Bromidrosis
Official title: The Use of the VASER System in the Treatment of Axillary Hyperhidrosis and/or Axillary Bromidrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Axillary Hyperhidrosis
Keywords: hyperhidrosis
bromidrosis
bromhidrosis
osmidrosis
hircismus
excessive
underarm
sweat
perspiration
Body Odor
Lead sponsor: Commons Aesthetic Plastic Surgery
Sponsor class: OTHER
Collaborators: name: Sound Surgical Technologies, LLC.
First posted: 2008-08-14
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with excessive underarm odor and sweating and/or odor are treated with the VASER system to determine the VASER's effectiveness in reducing underarm sweat and odor

Detailed description: Patients with excessive underarm sweat and/or odor are recruited. The effect that excessive underarm sweat and/or odor has on their lifestyle is evaluated. They are surgically treated with the VASER system and followed up for 6 months to evaluate side effects, adverse events and effectiveness. Additional lifestyle evaluations are completed for comparison to pre-surgery answers.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Willing and able to appear for all scheduled, post-operative visits
* Have axillary hyperhidrosis/bromidrosis that does not respond to conventional, non-invasive treatment

Exclusion Criteria:

* under the age of 18
* have undergone a prior surgical intervention for treatment of axillary hyperhidrosis (e.g.) Skoog procedure, ETS)
* have been treated with a systemic or topical agent for axillary hyperhidrosis in the past 30 days
* are deemed inappropriate candidates for surgery due to medical or mental health reasons
* are currently being treated with investigational agents or have participated in an investigational study within 60 days prior to surgery
* elect not to participate in the study

Primary outcomes:
measure: To assess the effectiveness of the VASER for treatment of axillary hyperhidrosis using patient self-report assessments
timeFrame: 6 months
measure: To assess the effectiveness of the VASER for the treatment of axillary bromidrosis using patient self report assessment
timeFrame: 6 months
Secondary outcomes:
measure: To assess patient's post-operative pain level following VASER using patient self report assessments.
timeFrame: 2 months
measure: To assess patients healing time following VASER treatment of axillary hyperhidrosis
timeFrame: 6 months
measure: To establish safe and effective procedural guidelines and surgical endpoints for the treatment of axillary hyperhidrosis using the VASER
timeFrame: 6 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Commons Aesthetic Plastic Surgery
state: California
Study officials:
References:
Clinical trial NCT00225693: V-Flex Plus PTX Drug Eluting Coronary Stent
Official title: ELUTES III - V-Flex Plus PTX Drug Eluting Coronary Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: coronary artery
restenosis
patency
drug eluting
stent
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2005-09-26
Enrollment: 150
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 study is intended to collect data to evaluate effectiveness and safety of drug eluting stent devices in a dose ranging assessment.


Eligibility criteria: Inclusion Criteria:

* Patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery.
* Patient must be an acceptable candidate for coronary artery bypass surgery
* Patient or legal guardian must have given informed consent
* Patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status, an IVUS examination and a diagnostic angiogram.

Exclusion Criteria:

* Patient must be less than 18 years old
* Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
* Patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.
* Patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye.
* Women of child bearing potential.
* Patient has other medical condition that any cause non-compliance with the protocol, confound the results or is associated with limited life expectancy.

Primary outcomes:
measure: Evaluation by IVUS of % diameter stenosis at follow up.
Secondary outcomes:
measure: Major adverse events
measure: Target lesion revascularization
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Contact Sponsor
state: Indiana
Study officials:
affiliation: UZ Gasthuisberg Leuven
name: Joseph Dens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00616993: Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-004)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammation
Lead sponsor: Sirion Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-15
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this phase III study is to determine the safety and efficacy of difluprednate in the treatment of inflammation following ocular surgery.


Eligibility criteria: Inclusion Criteria:

* Scheduled for unilateral ocular surgery.

Exclusion Criteria:

* Systemic administration of any corticosteroid or immunosuppressive drug in the 2 weeks prior to study enrollment.

Primary outcomes:
measure: The proportion of subjects with an anterior chamber cell grade of "0" and a flare grade of "0" on Day 14, compared between difluprednate and placebo groups.
timeFrame: Day 14
Secondary outcomes:
measure: The proportion of subjects with an anterior chamber cell grade of "0" and a flare grade of "0" on Day 7, compared between difluprednate and placebo groups.
timeFrame: Day 7
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Eye Associates of Fort Myers
state: Florida
Study officials:
affiliation: Sirion Therapeutics
name: Roger Vogel, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04016493: Long-term Outcomes of Tunnel Technique
Official title: Tunnel Versus Coronally Advanced Flap Combined With a Connective Tissue Graft for the Treatment of Gingival Recessions: Long Term (4 Years) Follow-up of a Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recession, Gingival
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2019-07-11
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Each patient (experimental unit) contributed a single recession. In cases of multiple recessions, the deepest one was included.

Brief summary: Few studies evaluate the outcomes beyond 1 year follow up for gingival recessions treatments using the tunnel technique in combination with connective tissue graft. The aim of this randomized controlled trial (RCT) was to compare the 4-year outcomes of the CAF versus the pouch/tunnel (TUN) technique both associated with CTG.


Eligibility criteria: Inclusion Criteria:

* Miller's class I recessions;
* Recession of 2 mm to 5 mm;
* Maxillary incisors, canines or premolars;
* Identifiable cementoenamel junction (CEJ);
* Patients minimum 18 years old;
* No/controlled periodontal disease;
* ASA1 or ASA2 (American Society of Anesthesiologists) general health status;
* Providing a signed informed consent form.

Exclusion criteria were:

* Smokers;
* Presence of cervical carious lesion;
* Pocket depth greater than 4 mm;
* Sites where previous muco-gingival therapy was performed;
* Pregnancy.
* In presence of non-carious cervical lesions, the anatomical CEJ was reconstructed by the use of a composite before the procedure.

Primary outcomes:
measure: Plaque Index Change
timeFrame: baseline, 6 months and 4 years
measure: Bleeding on probing score change
timeFrame: baseline, 6 months and 4 years
measure: Recession width change
timeFrame: baseline, 6 months and 4 years
measure: Gingival thickness change
timeFrame: baseline, 6 months and 4 years
measure: Keratinised mucosa height change
timeFrame: baseline, 6 months and 4 years
measure: Mean Root Coverage change
timeFrame: at 6 months and 4 years.
measure: PES Assessment change
timeFrame: Baseline, 6 months and 4 years
Secondary outcomes:
measure: Patient-related esthetic outcomes
timeFrame: 4 years
Other outcomes:
Locations:
Study officials:
References: