louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04457362: Wrist Arthroscopy Study
Official title: A Comparative Study Evaluating the Diagnostic Accuracy of Wrist Arthroscopy Using the NanoScope Compared to Conventional Arthroscopic Instrumentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrist Arthropathy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Cohort Study, Diagnostic
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the diagnostic efficacy of Arthrex NanoScope compared to conventional arthroscopic instruments. Patients with wrist pathology who are indicated for an arthroscopic procedure will be enrolled pre-operatively after a thorough discussion of the study aims, risks, and benefits. At the time of surgery, under standard conditions, using standard wrist arthroscopy portals, a diagnostic arthroscopy will be performed with the Arthrex Nanoscope. The diagnostic arthroscopy will be performed in a stepwise manner for consistency with notation of pathology and intended intervention. The diagnostic arthroscopy will then be performed with the standard arthroscopic equipment, again noting pathology and final intervention. Post-operatively, diagnostic accuracy, incidence of change in intervention, and surgeon rated ease of use and confidence will be determined.


Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years.
2. Wrist pathology based on clinical examination/imaging studies undergoing wrist arthroscopy for further evaluation/treatment.
3. Willingness to participate in the study

Exclusion Criteria:

* 1. Age \< 18 years.

Primary outcomes:
measure: Surgeon-Rated Radiocarpal Visualization With Arthrex Nanoscope
timeFrame: Day 1
measure: Surgeon-Rated Radiocarpal Visualization With Conventional Instrument
timeFrame: Day 1
measure: Surgeon-Rated Midcarpal Visualization With Arthrex Nanoscope
timeFrame: Day 1
measure: Surgeon-Rated Midcarpal Visualization With Conventional Instrument
timeFrame: Day 1
Secondary outcomes:
measure: Surgeon-rated Ease of Use of Arthrex NanoScope
timeFrame: Day 1
measure: Surgeon-rated Ease of Use of Conventional Instrument
timeFrame: Day 1
measure: Surgeon-rated Confidence in Arthrex NanoScope Diagnosis
timeFrame: Day 1
measure: Surgeon-rated Confidence in Conventional Instrument Diagnosis
timeFrame: Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Nader Paksima
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01278862: Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns
Official title: Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Decay
Keywords: Crowns
posterior teeth
CAD CAM crowns
digital veneer system
Lava
clinical
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2011-01-19
Enrollment: 77
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study aim is to compare Lava Computer Aided Design / Computer Aided Milling Computer Aided Machining (CAD/CAM)crowns that are veneered (covered) with porcelain that has been milled using CAD/CAM, with similar CAD/CAM Lava crowns that have been veneered with a hand fabricated porcelain covering.

Detailed description: Veneers will be randomly allocated to study crowns. Study crowns will be evaluated over three years. The test porcelain veneer is CAD/CAM milled as a veneer shell that is then fused to the CAD/CAM milled Lava crown to make the final crown to be cemented in the patient's mouth. This may be a more predictable technique in the fabrication of Lava crowns than current conventional methods.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age.
* Have at least one decayed back tooth in need of a crown
* Study tooth to be an upper or lower premolar or molar tooth/ teeth
* Study tooth to be vital and asymptomatic at start of study

Exclusion Criteria:

* Teeth which are non vital, have had root canal treatment
* Teeth which are pulp capped
* Sensitive teeth
* Significant untreated dental disease including periodontitis and rampant decay
* Pregnant or lactating women
* Patients with allergies to any of the materials to be used in the study
* Unable to attend the recall appointments

Primary outcomes:
measure: Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria
timeFrame: 1 year
measure: Gingival/Periodontal Health Based on Loe & Stillness Index, 1963.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Dental School
state: Michigan
Study officials:
affiliation: Univ of Michigan School of Dentistry
name: Dennis Fasbinder, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05294562: China Post-Market Clinical Follow-up of FACILLE®
Official title: China Post-Market Clinical Follow-up of FACILLE®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermal Filler
Hyaluronic Acid
Nasolabial Fold
Lead sponsor: SciVision Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-24
Enrollment: 1552
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Institution of Medical Cosmetology

Brief summary: The results showed that subjects tolerated the Sodium Hyaluronate Gel for Injection (FACILLE®) well, with no systemic AEs, SAEs, and unanticipated AEs and associated with high satisfaction and self-evaluated effectiveness. Nearly half of the subjects maintained correction for 12 months and were satisfied with the product 3 years after the first injection.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older of male or female;
* Have used or plan to use FACILLE® Sodium Hyaluronate Gel for Injection;
* Agree to participate and comply with the follow-up schedule of this study.

Exclusion Criteria:

* With a history of hypersensitivity or allergy to hyaluronic acid or any component of the device;
* Other circumstances were judged to be unsuitable for participating in the study by the investigator.

Primary outcomes:
measure: Adverse events reported during the study period
timeFrame: 36 months
Secondary outcomes:
measure: Subjects self-evaluating satisfaction
timeFrame: 2 weeks, 1, 3, 6, 12, 18, 24, 30 and 36 months post-injection
measure: Subjects self-evaluating effectiveness
timeFrame: 2 weeks, 1, 3, 6, 12, 18, 24, 30 and 36 months post-injection
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04011462: Perioperative Normothermia: Temperature and Prewarming Methods
Official title: Perioperative Normothermia: Temperature and Prewarming Methods
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypothermia
Keywords: Nursing
Hypothermia
Perioperative Nursing
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present proposal intends to determine the effect of prewarming on body temperature in the perioperative period of patients submitted to digestive system surgeries and to evaluate a perioperative "Zero-Heat-Flux Cutaneous" body temperature thermometer in comparison to the standard care (temporal thermometer in the preoperative and postoperative, and esophageal in the intraoperative period). This is a randomized clinical trial consisting of three groups, namely: preoperative warming of patients with blanket and cotton sheet (control); preoperative warming with forced air warming system for 20 minutes (Intervention 1), and participants submitted to preoperative warming with a forced air warming system for 30 minutes (Intervention 2).

Detailed description: The present proposal intends to determine the effect of prewarming on body temperature in the perioperative period of patients submitted to digestive system surgeries and to evaluate a perioperative "Zero-Heat-Flux Cutaneous" body temperature thermometer in comparison to the standard care (temporal thermometer in the preoperative and postoperative, and esophageal in the intraoperative period). This is a randomized clinical trial consisting of three groups, namely: preoperative warming of patients with blanket and cotton sheet (control); preoperative warming with forced air warming system for 20 minutes (Intervention 1), and participants submitted to preoperative warming with a forced air warming system for 30 minutes (Intervention 2)

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years and over at the time of data collection
* Patients submitted to elective oncological surgery of the digestive, curative or palliative system, with anesthesia duration of at least one hour

Exclusion Criteria:

* Subjects with body temperature equal to or greater than 38 ºC at the time of admission to the Surgical Center
* Patients submitted to video laparoscopic or minimally invasive surgeries

Primary outcomes:
measure: Number of patients with temperature below 36 degrees measured by "Zero-Heat-Flux Cutaneous" body temperature thermometer
timeFrame: Perioperative period
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: ICESP
Study officials:
References:
Clinical trial NCT01887262: Control Of Fluid Balance Guided by Body Composition Monitoring in Patients on PeritoneAl dialySiS
Official title: Control Of Fluid Balance Guided by Body Composition Monitoring in Patients on PeritoneAl dialySiS (COMPASS) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peritoneal Dialysis, Continuous Ambulatory
Keywords: fluid
edema
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Fresenius Medical Care Korea
First posted: 2013-06-26
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Bioimpedance-guided fluid management in peritoneal dialysis patients may provide better protection of residual renal function over 1 year period, compared with management guided by clinical information alone - such as blood pressure, body weight, and physician's physical examination.


Eligibility criteria: Inclusion Criteria:

* age bwten 20 and 75
* peritoneal dialysis \> 4 weeks duration
* written consent
* daily urine output \> 500 ml

Exclusion Criteria:

* subjects who are contraindicated to the bioimpedance measurement (pacemaker insertion state, defibrillator state, amputee, prosthesis, metal implants)
* pregnant women
* subjects who are expected to discontinue peritoneal dialysis with one year
* mixed dialysis modality (peritoneal + hemodialysis)
* hypoalbuminemic subjects (serum albumin \< 3.3 g/dL)
* high blood pressure (\> 160/100 mmHg despite antihypertensive medications)
* severe heart failure (NYHA FC III, or IV)

Primary outcomes:
measure: delta GFR
timeFrame: baseline and 12th month
Secondary outcomes:
measure: GFR
timeFrame: at 12th month
measure: time to anuria
timeFrame: over 12 months
measure: echocardiographic parameters
timeFrame: 12 months period
measure: BP
timeFrame: 12th month
measure: cardiovascular event
timeFrame: over 12 months
measure: BCM parameters
timeFrame: baseline and 12th month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital Clinical Trial Center
Study officials:
References:
citation: Van Biesen W, Williams JD, Covic AC, Fan S, Claes K, Lichodziejewska-Niemierko M, Verger C, Steiger J, Schoder V, Wabel P, Gauly A, Himmele R; EuroBCM Study Group. Fluid status in peritoneal dialysis patients: the European Body Composition Monitoring (EuroBCM) study cohort. PLoS One. 2011 Feb 24;6(2):e17148. doi: 10.1371/journal.pone.0017148.
citation: Baek SH, Oh KH, Kim S, Kim DK, Joo KW, Oh YK, Han BG, Chang JH, Chung W, Kim YS, Na KY. Control of fluid balance guided by body composition monitoring in patients on peritoneal dialysis (COMPASS): study protocol for a randomized controlled trial. Trials. 2014 Nov 6;15:432. doi: 10.1186/1745-6215-15-432.
Clinical trial NCT00188162: Minimum Dose CT Post Lung Biopsy
Official title: Can Minimum Dose CT Post Lung Biopsy Predict Patient Outcome?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim is to evaluate whether Minimum Dose CT (MnDCT) is useful in the management of patients post Lung Biopsy

Detailed description: Patients post Lung Biopsy have a chest X-ray (CXR) and a MnDCT post lung biopsy. Both studies are compared for the detection of a pneumothorax

Eligibility criteria: Inclusion Criteria:

* All Patients having a lung biopsy

Exclusion Criteria:

* None

Primary outcomes:
measure: Detection of Pneumothorax
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Narinder Paul, FRCP C
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06809062: ApoE Genotyping Analysis in Patients with Suspected Non-haemorrhagic Amyloid Angiopathy
Official title: ApoE Genotyping Analysis in Patients with Suspected Non-haemorrhagic Amyloid Angiopathy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Amyloid Angiopathy
Keywords: Cerebral Amyloid Angiopathy
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ischaemic stroke (from causes other than CAA, as CAA is not a frequent cause of ischaemic stroke) with associated stigmata of microangiopathy on MRI that may suggest associated CAA.

Brief summary: Ischaemic microangiopathic features have recently been incorporated into the criteria for cerebral amyloid angiopathy (CAA).

ApoE genotyping (presence of the E4 allele) is routinely used to help determine the aetiology of a haemorrhagic microangiopathy found on MRI.

Chronic ischaemic disease in CAA is characterised by the presence of :

* multispot pattern on the FLAIR sequence
* severe periventricular FLAIR hypersignals with posterior predominance

The main aim of this study was therefore to analyse the frequency of the presence of one (or two) E4 allele(s) on ApoE genotyping in patients with suspected CAA based on ischaemic MRI involvement with a typical radiological pattern.


Eligibility criteria: Inclusion Criteria:

* Patients with ischaemic stroke (from causes other than CAA, as CAA is not a frequent cause of ischaemic stroke) with associated stigmata of microangiopathy on MRI that may suggest associated CAA.
* Patients treated at Nîmes University Hospital

Exclusion Criteria:

* Patient refusing to participate

Primary outcomes:
measure: ApoE genotypage
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Anissa MEGZARI
role: STUDY_DIRECTOR
References:
Clinical trial NCT03925662: Mebendazole as Adjuvant Treatment for Colon Cancer
Official title: Clinical Study Evaluating Mebendazole as Adjuvant Therapy in Patients With Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Colorectal Cancer
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 40
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: mebendazole treating colon cancer

Detailed description: mebendazole as adjuvant treatment for colon cancer

Eligibility criteria: Inclusion Criteria:

* Colorectal cancer stage 4.

Exclusion Criteria:

* Agranulocytosis
* Pregnancy
* Allergy to mebendazole.

Primary outcomes:
measure: number of patients with tumour response
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Tanta University - Faculty of Pharmacy
name: Reham El-ghoneimy, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University - Faculty of Pharmacy
name: Sahar Hegazy, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University - Faculty of Pharmacy
name: Gamal el-azab, Prof
role: STUDY_DIRECTOR
affiliation: Tanta University
name: Fatma Zakaria, Prof
role: STUDY_CHAIR
References:
citation: Hegazy SK, El-Azab GA, Zakaria F, Mostafa MF, El-Ghoneimy RA. Mebendazole; from an anti-parasitic drug to a promising candidate for drug repurposing in colorectal cancer. Life Sci. 2022 Jun 15;299:120536. doi: 10.1016/j.lfs.2022.120536. Epub 2022 Apr 3.
Clinical trial NCT04970862: Evaluation of the Effect of Revision Surgery of Lumbar Adjacent Segment Degeneration
Official title: Evaluation of the Effect of Revision Surgery of Lumbar Adjacent Segment Degeneration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adjacent Segment Disease
Adjacent Segment Degeneration
Keywords: Adjacent Segment Degeneration
reversion surgery
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From January 2010 to June 2018, patients with lumbar spine disease hospitalized in orthopedics were screened out to meet the criteria

Brief summary: The purpose of this study was to investigate postoperative imaging changes and clinical symptom improvement in patients undergoing revision surgery for adjacent segment degeneration.


Eligibility criteria: Inclusion Criteria:

* For patients undergoing revision surgery in adjacent segments due to S-ASD, the revision surgery is at least half a year from the first operation;
* X-ray, CT and MRI examination data of the anterior and lateral extension of the lumbar spine were available within 1 month before surgery and at the last follow-up;
* Follow-up for at least 2 years after revision;

Exclusion Criteria:

* Patients with history of congenital spinal deformity, spinal tumor, spinal tuberculosis.

Primary outcomes:
measure: Visual Analog Scale (VAS) scores of low back pain and leg pain
timeFrame: 2 years after revision surgery
measure: Japanese Orthopedic Association (JOA) score
timeFrame: 2 years after revision surgery
measure: Oswestry Disability Index (ODI)
timeFrame: 2 years after revision surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Weishi Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03260062: Parent-Child Early Approaches to Raising Language Skills (PEARLS) Intervention
Official title: Pilot Intervention to Improve Language in Deaf Children With Cochlear Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deafness, Bilateral
Keywords: cochlear implants
language development
parenting intervention
maternal sensitivity
facilitative language techniques
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2017-08-24
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to develop and evaluate a parent training program, which aims to improve language. The study is being conducted to see if teaching parents positive parenting techniques and behavior strategies will improve the rate of language development in children with cochlear implants when compared to standard speech therapy (e.g., auditory-verbal therapy).


Eligibility criteria: Inclusion Criteria:

1. children who are severely to profoundly deaf and a cochlear implant candidate,
2. children who are 12 to 48 months,
3. English or Spanish as primary language spoken at home,
4. families educating their children in spoken language,
5. children who pass the cognitive screening, scoring 75 or above on the screening measure

Exclusion Criteria:

1. parents who do not consent to being videotaped,
2. children with moderate to severe developmental delays (as assessed using the Battelle Developmental Inventory (BDI-2) 2nd Edition for children ages 0 to 24 months or the Leiter International Performance Scale-Revised),
3. children with significant syndromes (e.g., CHARGE, autism, cerebral palsy) or severe brain abnormalities,
4. families who do not receive their auditory-verbal therapy from University of Miami (UM). Further, children who have already completed the BDI-2 within the past year as part of their Early Steps (Florida Early Intervention) program will not have it re-administered.

Primary outcomes:
measure: Change in parental sensitivity
timeFrame: Baseline, Week 10
Secondary outcomes:
measure: Change in use of higher-level versus lower-level language strategies
timeFrame: Baseline, Week 10
measure: Change in parental involvement and self-efficacy
timeFrame: Baseline, Week 10
measure: Change in Auditory Skills
timeFrame: Baseline, Week 10
Other outcomes:
Locations:
city: Miami
country: United States
facility: Don Soffer Clinical Research Building
state: Florida
Study officials:
affiliation: University of Miami
name: Ivette Cejas, PhD
role: PRINCIPAL_INVESTIGATOR
References: