louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02241772: A Study on the Effects of TA-8995 on Lp(a) in Subjects With Elevated Lp(a)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Elevated Lp(a)
Lead sponsor: Xention Ltd
Sponsor class: INDUSTRY
First posted: 2014-09-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study in males and females with elevated Lp(a) to look at the effects of TA-8995 on Lp(a) levels.


Eligibility criteria: Inclusion Criteria:

* Male and female (of non-child bearing potential) subjects with elevated Lp(a) levels

Exclusion Criteria:

* Clinically significant medical history
* Abnormal laboratory results (other than lipid levels) or vital signs
* Receiving any other drug therapy

Primary outcomes:
measure: To evaluate the change from baseline in (Lp(a) levels after 12 weeks of treatment with TA-8995.
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
References:
Clinical trial NCT04823572: Treatment of Periodontal Intrabony Defects With A-PRF or OFD
Official title: Efficacy of a New-generation Platelet-Rich Fibrin in the Treatment of Periodontal Intrabony Defects : a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Keywords: Intrabony Defects
Periodontal Regeneration
A-PRF
Advanced Platelet-Rich Fibrin
Open Flap Debridement
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized clinical trial was to clinically evaluate and compare the healing of intrabony defects after treatment with advanced platelet-rich fibrin (A-PRF+) toped flap debridement (OFD) in periodontitis patients.

Detailed description: Thirty (30) intrabony defects are randomly divided in two treatment groups: test (n = 15) and control (n = 15). The intrabony defects are filled with A-PRF+ (n=15) in the test group, respectively treated with open flap debridement in the control group, and fixed with sutures to ensure wound closure and stability.

Eligibility criteria: Inclusion Criteria:

* no systemic diseases
* a good level of oral hygiene
* presence of a 2-, 3-, or combined 2-3-wall intrabony defect with a defect angle of 20-40 (+/- 5) degrees
* with a minimum PPD of 6 mm and intrabony component of a minimum 4 mm as detected on radiographs
* no smoking

Exclusion Criteria:

* systemic diseases that could influence the outcome of the therapy
* poor oral hygiene
* smoking
* horizontal bone loss

Primary outcomes:
measure: Periodontal clinical parameters
timeFrame: Change from baseline after 6 month and after 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University, Department of Periodontology
Study officials:
affiliation: Semmelweis University
name: Dőri Ferenc, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04424472: Assessing the Utility of Ultrasound Compared to Cross-Sectional Imaging in the Follow-up of Patients With Renal Cell Carcinoma
Official title: Assessing the Utility of Ultrasound Compared to Cross-Sectional Imaging in the Follow-up of Patients With Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Cell Carcinoma
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to determine the utility of renal ultrasonography (US) in the detection of abdominal recurrences after definitive therapy for renal cell carcinoma (RCC) and compare the detection rate to that of cross-sectional imaging.


Eligibility criteria: Inclusion Criteria:

* Patients must be 18 year of age or older.
* Patients having undergone radical or partial nephrectomy for the indication of renal cell carcinoma.
* Most recent imaging study must have been either computed tomography (CT) or magnetic resonance imaging (MRI).

Exclusion Criteria:

* Patients with pT4 disease (tumor invades beyond the Gerota fascia: including contiguous extension into the ipsilateral adrenal gland).
* Patients with metastatic disease prior to time of surgery requiring systemic treatment.
* Patients with another active cancer diagnosis requiring systemic treatment.
* Patients with contrast allergies.
* Patients with baseline chronic kidney disease (GFR \< 45 ml/min/1.73 m2).

Primary outcomes:
measure: Utility of Renal Ultrasonography (US) in the detection of abdominal recurrences
timeFrame: 4 weeks
Secondary outcomes:
measure: Radiation Burden
timeFrame: 5 years
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Health System
state: Kansas
Study officials:
References:
Clinical trial NCT01464372: Electromagnetic Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder
Official title: Electrical Field Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder - Version: 3.0 Dated 16 APR 2012.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Urinary Incontinence, Urge
Keywords: Urinary Incontinence, Urge
Peripheral Nerve Stimulation
Lead sponsor: EMKinetics, Inc
Sponsor class: INDUSTRY
First posted: 2011-11-03
Enrollment: 130
Sex: FEMALE
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 collect data on the safety and efficacy of using an electrical field stimulation device, compared to a sham (placebo) device, to treat urinary urgency, urinary frequency and urge incontinence.


Eligibility criteria: Inclusion Criteria:

* Urinary Urge Incontinence
* Urinary Frequency

Exclusion Criteria:

* Primary complaint of Stress Incontinence
* Neurogenic bladder
* Overflow Incontinence
* Functional Incontinence

Primary outcomes:
measure: Reduction of incontinence episodes from baseline to follow-up greater for device arm than sham arm
timeFrame: One week after final treatment visit
measure: No Serious Adverse Events or Unanticipated Adverse Device Effects
timeFrame: First treatment through follow-up (one week after last treatment)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Birmingham Urologic Associates
name: Kenneth Peters, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alliance Urology Specialists
name: Scott MacDiarmid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00332072: Safety and Efficacy Study of Bimatoprost/Timolol Fixed Combination in Patients Wtih Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2006-06-01
Enrollment: 541
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 assess the safety and efficacy of Bimatoprost/Timolol Fixed Combination in the treatment of glaucoma or ocular hypertension


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes
* Patient needs IOP-lowering drug in both eyes

Exclusion Criteria:

* Uncontrolled medical condition
* Contraindication to beta-adrenoceptor antagonist therapy

Primary outcomes:
measure: IOP
Secondary outcomes:
Other outcomes:
Locations:
city: Ogden
country: United States
state: Utah
Study officials:
References:
citation: Lewis RA, Gross RL, Sall KN, Schiffman RM, Liu CC, Batoosingh AL; Ganfort Investigators Group II. The safety and efficacy of bimatoprost/timolol fixed combination: a 1-year double-masked, randomized parallel comparison to its individual components in patients with glaucoma or ocular hypertension. J Glaucoma. 2010 Aug;19(6):424-6. doi: 10.1097/IJG.0b013e3181bdb586. No abstract available.
Clinical trial NCT03683472: Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder
Official title: Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Keywords: Anxiety, worry, mindfulness, meditation
Lead sponsor: MindSciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Brown University
First posted: 2018-09-25
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators propose to develop and adapt Unwinding Anxiety phone app specifically for individuals with generalized anxiety disorder.

Detailed description: The study aims are to (1) develop and refine Unwinding Anxiety for individuals with generalized anxiety disorder, (2) determine user engagement and acceptability as well as measure effect sizes of the program vs. treatment as usual, and (3) preliminarily test mechanisms of action. The knowledge gained will set the stage for a number of future studies related to further elucidating the mechanisms of mindfulness, and the clinical efficacy and utility of this type of training delivered via digital therapeutics in general. Specifically, this study will provide necessary variances for powering larger phase 2 studies.

Eligibility criteria: Inclusion Criteria:

* Owns a smart phone
* GAD - 7 is equal to or greater than 10

Exclusion Criteria:

* If using psychotropic medication - not on a stable dosage for at least 6 weeks
* Medical disorder of the severity that would interfere with ability to participate
* Not being fluent in English (due to instructions provided in English)
* As needed use (i.e. prn) of benzodiazepines
* Psychotic disorder,
* Previous MT (e.g. MBSR, other Claritas MindSciences training programs).

Primary outcomes:
measure: UA Program engagement
timeFrame: Two months
measure: Change in worry
timeFrame: Baseline, two months
Secondary outcomes:
measure: Change in non-reactivity & awareness
timeFrame: Baseline, two months
measure: UA Program Acceptability
timeFrame: Two months
Other outcomes:
measure: Change in anxiety
timeFrame: Baseline, two months
measure: Change in self-regulation
timeFrame: Baseline, two months
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Judson Brewer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roy A, Hoge EA, Abrante P, Druker S, Liu T, Brewer JA. Clinical Efficacy and Psychological Mechanisms of an App-Based Digital Therapeutic for Generalized Anxiety Disorder: Randomized Controlled Trial. J Med Internet Res. 2021 Dec 2;23(12):e26987. doi: 10.2196/26987.
Clinical trial NCT05819372: Finite Element and One Point Fixation
Official title: Role of Finite Element Analysis for Selection of Single Point Fixation in Zygomaticomaxillary Complex Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Zygomaticomaxillary Complex Fracture
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 1
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: * A cone beam CT (CBCT) scan of the patient, will be used to create a 3D scanned image of ZMC
* 3D images will be introduced to finite element (FA)software to evaluate Stresses (MPa) and Life time (cycle) For each model and determine which point of fixation is the best
* After application this point of fixation on the patient
* Finite element analysis will be done again to verify the previous results


Eligibility criteria: Inclusion Criteria:

* Fit to general anesthesia (GA)
* Isolated minimally displaced zygomaticomaxillary complex (ZMC) fracture

Exclusion Criteria:

* absence of other facial trauma, mandibular condylar fracture

Primary outcomes:
measure: Stresses by megapascal (MPa)
timeFrame: immediately after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university
Study officials:
References:
Clinical trial NCT02820272: Water for Reducing Pain in Negative Pressure Wound Therapy
Official title: Cold Water for Reducing Pain in Negative Pressure Wound Therapy Dressing Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Treatment
Keywords: Cold water
Negative pressure wound therapy
pain
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Negative pressure wound therapy (NPWT) is a technique using vacuum dressing to promote wound healing in complicated wound. However for many patients, the application and removal of the NPWT is source of procedural pain. Some techniques had been reported to reduce these pain such as administering topical lidocain or normal saline solution before the dressing change. The authors hypothesized that administering cold water into the NPWT sponge would decrease pain during dressing changes.


Eligibility criteria: Inclusion Criteria:

* Open wounded patient who is treated by negative pressure wound therapy (NPWT) with the age between 18-70 years old.

Exclusion Criteria:

* The patient who has decrease sensation at cured wound region
* The patient who has Glasgow coma scale less than 15
* The patient who cannot provide pain scale data
* The patient who has diabetic ulcer or other chronic sores
* The patient who denies to participate in research project.

Primary outcomes:
measure: Pain reduction during dressing changes assessed by Visual Analogue Scale (VAS)
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Fernandez R, Green HL, Griffiths R, Atkinson RA, Ellwood LJ. Water for wound cleansing. Cochrane Database Syst Rev. 2022 Sep 14;9(9):CD003861. doi: 10.1002/14651858.CD003861.pub4.
Clinical trial NCT04559672: Cervical Laminoplasty Versus Laminectomy and Fusion: the Long-term Results Comparison
Official title: Cervical Laminoplasty Versus Laminectomy and Fusion: the Long-term Results Comparison
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myelopathy Cervical
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent cervical laminoplasty or laminectomy and fusion surgery due to degenerative cervical myelopathy in our hospital from January 1, 2005 to January 1, 2015 were screened and included according to the eligibility criteria.

Brief summary: The objective of this study is to retrospectively analyze and compare the long-term clinical and radiographic results of multi-level laminoplasty to multi-level laminectomy and fusion for the treatment of patients with cervical myelopathy or myeloradiculopathy.


Eligibility criteria: Inclusion Criteria:

* Patients aged at least 18 years
* The patient has the diagnosis of degenerative cervical myelopathy
* The myelopathy or myeloradiculopathy requires a posterior cervical decompression of the spinal canal involving two or more contiguous intervertebral levels including and between C3 and C7
* More than five years of follow-up time

Exclusion Criteria:

* Presence of primary focal anterior compression of the cervical spinal cord
* Previous surgery of the cervical spine
* Tumor, infection, or trauma of the cervical spine or cord
* Patients with ankylosing spondylitis
* Patients with neurodegenerative diseases, or any neuropathies

Primary outcomes:
measure: Change of Japanese Orthopaedic Association Score (JOA)
timeFrame: baseline, 12 months post-treatment and through study completion, an average of 10 year
measure: Change of Neck Disability Index (NDI)
timeFrame: baseline, 12 months post-treatment and through study completion, an average of 10 year
measure: Change of Sagittal Lordosis Angle
timeFrame: baseline, 12 months post-treatment and through study completion, an average of 10 year
measure: Reoperation rate
timeFrame: through study completion, an average of 10 year
Secondary outcomes:
measure: Change of Pain Scores on the Visual Analog Scale (VAS)
timeFrame: baseline, 12 months post-treatment and through study completion, an average of 10 year
measure: Change of Range of Motion
timeFrame: baseline, 12 months post-treatment and through study completion, an average of 10 year
measure: Complication rate
timeFrame: through study completion, an average of 10 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
Study officials:
affiliation: Shanghai Changzheng Hospotal
name: Xuhua Lu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03605472: Comparison of Cervical Ultrasound and Echoscintigraphy for Preoperative Localization Diagnosis in Primary Hyperparathyroidism
Official title: Comparison of Cervical Ultrasound and Echoscintigraphy for Preoperative Localization Diagnosis in Primary Hyperparathyroidism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Hyperparathyroidism
Keywords: primary hyperparathyroidism
cervical ultrasound
echoscintigraphy
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2018-07-30
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: DIAGNOSTIC

Brief summary: The biological diagnosis of the primary hyperparathyroidism is now facilitated by the reliability of the balance of phosphate and calcium and the dosage of parathyroid hormone (PTH).

This diagnosis of preoperative localization is important as surgery are now targeted to the responsible lesion.

The "gold standard" for this localization is the cervical ultrasound exploring the usual sites of adenomas and a MIBI scintigraphy (the parathyroid adenoma significantly concentrating this cell marker).

However, the diagnosis of preoperative localization remains a subject of discussion as to the most appropriate tests. Indeed, the morphological diagnosis is performed at the ultrasound stage in more than half the cases. It is the new performance of this morphological examination that makes it possible to obtain these results.


Eligibility criteria: Inclusion Criteria:

* Patients with primary hyperparathyroidism with surgery indication
* Age \> 18yo

Exclusion Criteria:

* surgical contraindication
* medical treatment by cinacalcet
* non sporadic hyperparathyroidism
* Age \<18yo
* Protected by the law

Primary outcomes:
measure: Adenoma parathyroid diagnosed using cervical ultrasound
timeFrame: Day 0
measure: Adenoma parathyroid diagnosed using echoscintigraphy
timeFrame: Day 0
measure: Adenoma parathyroid diagnosed using anatomopathology
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
Clinical trial NCT03146572: Primary Care and Parenting
Official title: Utilizing the Primary Care Setting to Deliver a Brief Program to Enhance Parenting Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Parenting
Knowledge, Attitudes, Practice
Development, Child
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Society of Developmental and Behavioral Pediatrics
First posted: 2017-05-10
Enrollment: 61
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study to evaluate potential impact of a brief, low-cost primary care-based intervention of parenting self-efficacy, knowledge, and behavior.

Detailed description: Enriching parenting behaviors in early childhood promotes child development and offers a promising strategy to reduce future educational disparities. However, current interventions are limited by cost and have not been widely disseminated. Recognized as a target for research to improve early childhood development and subsequent school readiness skills among at-risk families, the primary care setting offers an ideal opportunity to reach the millions of children living in poverty. However, what remains unknown is how to more efficiently leverage the primary care setting to deliver a sustainable and effective preventive program to promote positive parenting behaviors and encourage early childhood development in low-income families. Therefore, the investigators designed Sit Down and Play (SDP) a brief parent-directed program delivered in the primary care setting. Modeled after the widely disseminated literacy program Reach Out and Read and grounded in social cognitive theory, SDP is intended to take place during each pediatric well-child visit occurring in a child's first two years with the goal of promoting positive parenting behaviors.

Eligibility criteria: Inclusion Criteria:

Parent is 18 years or older Child is present for a 6, 9, or 12 month well-child visit who attends University of Illinois at Chicago (UIC) for well-child care Adult present with child at appointment is parent/caregiver of child

Exclusion Criteria:

Parent is non-English speaking Child is acutely sick

Primary outcomes:
measure: Change in Parental Knowledge
timeFrame: Enrollment and 7 months post-enrollment
measure: Change in participation in cognitively stimulating activities
timeFrame: Enrollment and 7 months post-enrollment
measure: Change in parenting self-efficacy
timeFrame: Enrollment and 7 months post-enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Reshma Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: