louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04270019: Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration
Official title: The Use of Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Peripheral Nerve Injury
Nerve Injury
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This study will be a randomized, double-blind, placebo-controlled human clinical trial.
Primary purpose: TREATMENT

Brief summary: PEG is a fusogen, a type of chemical that aids in mediating cell fusion. PEG helps nerve cells recover neuronal continuity by removing plasmalemmal-bound water which opens the axonal ends on both sides of the injury. Opening axonal ends permits the nerve ends to reconnect and begin regeneration. PEG has been tested on animal models extensively and in earthworm models has been shown to induce fusion rates in 80-100% of neuronal cells. In crushed or severed mammalian sciatic nerves PEG has enhanced neuronal continuity to baseline functioning levels.

Human applications for PEG have been tested by Bamba and colleagues in a case series with encouraging results. No studies, to our knowledge, have prospectively examined the use of PEG in peripheral nerve injuries. We propose a placebo controlled, double-blinded randomized controlled trial to test the hypothesis that local PEG administration can enhance sensory nerve regeneration following digital nerve transection compared to surgery alone.


Eligibility criteria: Inclusion Criteria:

* (1) surgery within twenty-four hours of injury (2) surgery completed in the minor procedures unit of the Halifax Infirmary.

Exclusion Criteria:

* (1) patients with cognitive impairment

Primary outcomes:
measure: Change in Sensory Recovery
timeFrame: Testing to be done at one month, three months, and six months post-operatively.
Secondary outcomes:
measure: Functional Recovery
timeFrame: Administered six months post-operatively. Maximum score of 100, minimum score of 0. A higher score means better functional recovery.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06775119: Feasibility Study of a Neuromuscular Fatigue Test and Associated Hemodynamic Responses: Application in Healthy Volunteers for Use in Patients with Chemotherapy-treated Breast Cancer
Official title: Feasibility Study of a Neuromuscular Fatigue Test and Associated Hemodynamic Responses: Application in Healthy Volunteers for Use in Patients with Chemotherapy-treated Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Muscle
Heart
Lead sponsor: Institut de cancérologie Strasbourg Europe
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This cross-sectional and single-center study aims to progressively induce an increase in peripheral fatigue during successive efforts in healthy subjects. Participants will undergo three evaluations, each lasting one and half hours, to validate the test and assess its reproducibility. These three visits will be conducted at a minimum interval of 48 hours.


Eligibility criteria: Inclusion Criteria:

* Man or woman
* Informed consent
* Age ≥ 18 years old
* Affiliation to a social security system
* Able to speak, read and understand French
* Practice physical activity 1 to 5 times per week, without reaching a level of intense training or high-level performance.

Exclusion Criteria:

* History of cancer
* Any known chronic pathology
* Protected minor or adult
* Psychiatric, musculoskeletal or neurological problems
* Implantation of a pacemaker
* Pregnant woman
* Presenting at least one contraindication to the use of transient blood flow occlusion

Primary outcomes:
measure: Evaluation of the progressive changes in the level of peripheral fatigue through the consecutive blocks.
timeFrame: All measurements will be taken at the end of each of the four exercise bouts, during the same visit.
Secondary outcomes:
measure: Correlation between peripheral fatigue and haemodynamic responses
timeFrame: Correlation between variables measured at the end of each of the four exercise bouts, during the same visit
measure: Validate the feasibility of the test on the following secondary parameter: reproducibility of the test
timeFrame: 2 to 7 days between sessions 2 and 3.
measure: Validate the feasibility of the test on the following secondary parameter: absence of transient discomfort
timeFrame: All measurements will be taken at the end of each of the four exercise bouts, during the same visit
measure: Validate the feasibility of the test on the following secondary parameter: Tolerance to peripheral nerve stimulation using the self-reports of pain intensity scales.
timeFrame: All measurements will be taken during the same visit, at the end of each of the four exercise bouts
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe
Study officials:
affiliation: Institut de cancérologie Strasbourg Europe
name: Roland SCHOTT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03213119: Boosting Reward-based Attention Through VEstibular STimulation
Official title: Boosting Reward-based Attention Through VEstibular STimulation
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Brain Lesion of the Right Hemisphere
Unilateral Spatial Neglect for Half of Them
Keywords: Caloric Vestibular Stimulation Reward
Brain Stimulation
Reward
Vestibular System
Cingulate Cortex
Cancellation Tasks
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The exploration of space is more effective when intrinsically rewarding elements are located in the visual scene. Thus, rewards could be exploited as a novel rehabilitation approach to various attentional disorders. The first part of the project aims to characterize these effects at the behavioural level. The interventional part consists then in the administration of Caloric Vestibular Stimulation (CVS), which by means of injection of a small quantity of water in the external ear activates the vestibular organs and subsequently vestibular-related brain areas. Among the observed brain activations, the possibility to reach cingulate areas appears particularly interesting because it foreshadows the possibility to further enhance attentional capture by rewards.

CVS will be delivered to patients with brain lesion of the right hemisphere, engaged in cancellation tasks requiring the processing of targets of different nature (e.g. monetary or neutral). The main prediction is that CVS administration would enhance spatial exploration in terms of center of gravity of the cancellation and improved accuracy as a function of the type of target processed (e.g. its value).


Eligibility criteria: Inclusion Criteria:

* More than 18 years of age, less than 85
* right handed
* Benefit of social health security
* Normal or corrected-to-normal vision
* Brain lesion localised in the right hemisphere, confirmed by CT or MRI

Exclusion Criteria:

* Anamnesis of neurological of psychiatric illness
* Pregnancy or breastfeeding
* Administrative measures restricting legal rights
* Recent participation to other brain stimulation studies (\< 1 week)
* Perforation of the tympanic membrane
* Anamnesis of recurrent otitis media

Primary outcomes:
measure: Center of Gravity (pixels).
timeFrame: Days 1, 2, and 3
Secondary outcomes:
measure: Reaction times (ms).
timeFrame: Days 1, 2, and 3.
measure: Response accuracy (%)
timeFrame: Days 1, 2, and 3.
Other outcomes:
Locations:
city: Bron
country: France
facility: CRNL, équipe IMPACT (CNRS UMR5292, INSERM U1028)
city: Saint-Genis-Laval
country: France
facility: Service de médecine et réadaptation neurologique, Hôpital Henry Gabrielle
Study officials:
References:
Clinical trial NCT02533219: Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia
Official title: Phase II Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Hyperinsulinemic Hypoglycemia, Persistent
Congenital Hyperinsulinism
Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)
Keywords: Hyperinsulinemic hypoglycemia
PET/CT
PET/MRI
[18F]-DOPA
PET/MR
Congenital Hyperinsulinism
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2015-08-26
Sex: ALL
Maximum age (years): 64
Standard ages: CHILD
ADULT

Brief summary: The primary objective of this study is to evaluate the utility of \[18F\]-DOPA PET to provide improved presurgical planning and distinguish between focal and diffuse forms of HI. The investigators will perform descriptive analysis, relying on visual analysis to diagnose and localize a focal lesion. Our findings will be compared to surgical histopathology to determine sensitivity and specificity or this technique. The investigators will also track patient surgical outcomes, specifically whether the patient is surgically "cured" or still requires medical management to control residual hypoglycemia.

Detailed description: Hyperinsulinemic hypoglycemia is caused by low glucose due to excessive insulin secretion and remains difficult to treat because of the requirement for extensive amounts of glucose and the lack of effective long-term medical therapy. Correct diagnosis, localization, and limited excision of the focal lesion will result in a complete cure of the patient. In contrast, medically unresponsive diffuse disease requires a near total pancreatectomy, greatly increasing the risk of future diabetes mellitus. Fortunately, \[18F\]-DOPA PET has been shown to be a useful noninvasive imaging method for distinguishing between focal and diffuse forms of hyperinsulinemic hypoglycemia. In this study, the investigators seek to validate the effectiveness of using PET/MR and PET/CT with F-DOPA to accurately and reliably detect and localize disease.

Eligibility criteria: Inclusion Criteria:

* All Patients clinically diagnosed with Hyperinsulinemia of any age
* Patients in need of PET scan
* Patients that require sedation
* Patients that do not require sedation

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

* Patients without Hyperinsulinemia
* Patients who are or may be pregnant
* Serious intercurrent medical illness other than hypoglycemia that precludes having the scan either because of patient instability or concerns about potential toxicity.
* Patient's requiring emergency surgical intervention that would be inappropriately delayed by \[18F\]-DOPA PET imaging.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
References:
Clinical trial NCT04532619: A Substance Use Adaptation of Fathering Through Change
Official title: A Pilot Study of the Fathering Through Change Intervention for Fathers With Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Substance Use
Lead sponsor: University of Oregon
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 41
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a randomized control trial of the Fathering Through Change intervention, delivered via text messaging, to fathers in recovery for substance use disorders.


Eligibility criteria: Inclusion Criteria:

* identify as being in recovery
* abstinent from illicit substances for at least 1 day and less than one year at time of enrollment
* parenting responsibilities for a child between the ages of 3-16
* spend at least 2 hours per week with child between ages of 3-16
* English speaking

Exclusion Criteria:

-

Primary outcomes:
measure: TOPSE: Group Mean Change at 6 Weeks and 4 Months on the Tool of Parenting Self-Efficacy
timeFrame: baseline to 6 weeks and baseline to 4 months
measure: PPI Harsh: Group Mean Change at 6 Weeks and 4 Months the Parenting Practices Interview Harsh Parenting Subscale
timeFrame: baseline to 6 weeks and baseline to 4 months
measure: PPI Inept: Group Mean Change at 6 Weeks and 4 Months the Parenting Practices Interview Inept Parenting Subscale
timeFrame: baseline to 6 weeks and baseline to 4 months
measure: PPI Prosocial: Group Mean Change at 6 Weeks and 4 Months the Parenting Practices Interview Prosocial Parenting Subscale
timeFrame: baseline to 6 weeks and baseline to 4 months
Secondary outcomes:
measure: Substance Use: Group Mean Change at 6 Weeks and 4 Months on Any Use in the Last 30 Days
timeFrame: baseline to 6 weeks and baseline to 4 months
measure: Substance Use: Group Mean Change at 6 Weeks and 4 Months on Days of Use the Last 30
timeFrame: baseline to 6 weeks and baseline to 4 months
measure: SDQ: Group Mean Change at 4 Months on Child Behavior
timeFrame: baseline to 4 months
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Willamette Family Treatment Center
state: Oregon
Study officials:
affiliation: University of Oregon
name: Camille C Cioffi, PhD
role: STUDY_DIRECTOR
References:
citation: DeGarmo DS, Jones JA. Fathering Through Change (FTC) intervention for single fathers: Preventing coercive parenting and child problem behaviors. Dev Psychopathol. 2019 Dec;31(5):1801-1811. doi: 10.1017/S0954579419001019.
Clinical trial NCT05745519: Discussion on Pulse Diagnosis and Heart Rhythm Variability of Patients With Chronic Insomnia
Official title: Discussion on Pulse Diagnosis and Heart Rhythm Variability of Patients With Chronic Insomnia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Rate Variability
Insomnia Chronic
Keywords: Insomnia
Pulse
Heart rate variability
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: In the experimental group, select subjects who meet the following conditions: aged 40-79 years, who complained of insomnia symptoms in the past month, at least three times a week for one month, such as: difficulty falling asleep, waking up in the middle of the night, unable to wake up Falling asleep, waking up in the morning still feeling sleepy. Control group: healthy voluntary subjects aged 40-79 without insomnia.

Brief summary: Discuss the objective assessment of patients with insomnia by pulse diagnosis, and measure by subjective questionnaire and physiological instruments.

Detailed description: In Taiwan, insomnia is a prevalent illness. Clinical symptoms of sleep disturbances are rather typical now that the epidemic has taken hold. Pulse diagnosis is an important diagnostic method for insomnia in traditional Chinese medicine(TCM). TCM pulse diagnosis is not yet a widely used clinical diagnostic method for illnesses, nevertheless. Clinical use and teaching should benefit greatly if pulse diagnosis or learning can be made more objective or data-based.

Eligibility criteria: Inclusion Criteria:

* aged 40-60 years
* Complaints of insomnia symptoms in the past month that lasted for at least one week, such as difficulty falling asleep, waking up easily in the middle of the night, unable to fall asleep after waking up, still not getting enough sleep after waking up in the morning
* The score of sleep disorder on the Pittsburgh Sleep Quality Scale was more than 5 points

Exclusion Criteria:

* History of psychiatric disorders
* History of sleep apnea or nocturnal myoclonus
* Center or neurodegenerative disease
* Cancer
* Melatonin or sleeping pills use in the past month

Primary outcomes:
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: 15 minutes
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 15 minutes
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 15 minutes
measure: The Green Climacteric Scale(GCS)
timeFrame: 15 minutes
measure: General Sleep Disturbance Scale(GSDS)
timeFrame: 15 minutes
measure: Constitution in Chinese Medicine Questionnaire (CCMQ)
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Ministry of Health and Welfare Tainan Hospital
Study officials:
References:
Clinical trial NCT02186119: A Study of Abicipar Pegol in Patients With Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Macular Edema
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-07-10
Enrollment: 151
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: This is a safety and efficacy study of abicipar pegol in patients with diabetic macular edema.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of diabetes mellitus (Type 1 or 2)
* Decreased vision due to diabetic macular edema in at least 1 eye
* Best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better in the fellow eye

Exclusion Criteria:

* Stroke or heart attack within the past 3 months
* History of vitrectomy, macular surgery, or glaucoma surgery in the study eye
* Cataract or refractive surgery in the study eye within the last 3 months
* Laser photocoagulation of the study eye within the last 3 months

Primary outcomes:
measure: Change from Baseline in Best Corrected Visual Acuity (BCVA)
timeFrame: Baseline, Week 28
Secondary outcomes:
measure: Percentage of Patients with a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
timeFrame: Baseline, 28 Weeks
measure: Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye
timeFrame: Baseline, Week 28
measure: Percentage of Patients with a BCVA of ≥70 Letters
timeFrame: 28 Weeks
measure: Percentage of Patients with Resolution of Macular Edema
timeFrame: 28 Weeks
Other outcomes:
Locations:
city: Gilbert
country: United States
state: Arizona
city: Abilene
country: United States
state: Texas
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06218719: Studying Patterns in Patient Engagement Among Tardive Dyskinesia Patients
Official title: Examining Engagement Patterns: An Observational Exploration About Tardive Dyskinesia Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Tardive Dyskinesia
Keywords: tardive dyskinesia
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tardive dyskinesia patients who are actively considering enrolling in a clinical trial for the said condition, but have not yet completed enrollment and randomization phases.

Brief summary: The statistical analysis of the collected data aims to reveal the many factors that influence patient involvement in clinical trials. Findings will be disseminated through conferences and scholarly papers to benefit all parties participating in clinical trials.

These findings will help to shape the design of future clinical trials for people with tardive dyskinesia, as well as enhance recruiting techniques and retention rates.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of tardive dyskinesia
* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* No prior treatment for tardive dyskinesia

Exclusion Criteria:

* Enrolled in another research study
* Inability to provide written informed consent
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Primary outcomes:
measure: Rate of patients who decide to enroll in a tardive dyskinesia clinical research.
timeFrame: 3 months
measure: Number of tardive dyskinesia study participants who remain in clinical study until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Horiguchi J, Watanabe K, Kondo K, Iwatake A, Sakamoto H, Susuta Y, Masui H, Watanabe Y. Efficacy and safety of valbenazine in Japanese patients with tardive dyskinesia: A multicenter, randomized, double-blind, placebo-controlled study (J-KINECT). Psychiatry Clin Neurosci. 2022 Nov;76(11):560-569. doi: 10.1111/pcn.13455. Epub 2022 Sep 17.
citation: Hauser RA, Factor SA, Marder SR, Knesevich MA, Ramirez PM, Jimenez R, Burke J, Liang GS, O'Brien CF. KINECT 3: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Valbenazine for Tardive Dyskinesia. Am J Psychiatry. 2017 May 1;174(5):476-484. doi: 10.1176/appi.ajp.2017.16091037. Epub 2017 Mar 21.
citation: Farrar M, Lundt L, Franey E, Yonan C. Patient perspective of tardive dyskinesia: results from a social media listening study. BMC Psychiatry. 2021 Feb 15;21(1):94. doi: 10.1186/s12888-021-03074-9.
Clinical trial NCT06044519: A Single Center Trial of Donor Site Wound Dressings After Split Thickness Skin Grafting.
Official title: A Single Centre Randomized Control Trial of Donor Site Wound Dressing After Split Thickness Skin Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Donor Site Complication
Skin Graft Scar
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The goal of this clinical trial\] is to compare different types of dressings used and there outcomes on STSG donor site wound. The main question\[s\] it aims to answer are:

* the effectiveness of different donor site dressings and their adverse outcomes
* the satisfaction of patients with the donor site dressing will be observed. Participants will randomly allocated different types of dressings for split thickness skin graft donor site wound which include alginate hydrocolloid hydrofiber silicon film guaze


Eligibility criteria: Inclusion Criteria:

* . Patients of aged 18 years and above of either gender underwent single donor-site wounds after split-skin grafting and surface area larger than 10 cm2 were included in the study

Exclusion Criteria:

* Patients on chemotherapy or corticosteroids were excluded from the study. Non-probability consecutive sampling was employed

Primary outcomes:
measure: to asses the effective of dressings by measuring itching , pain and scarring
timeFrame: six month
Secondary outcomes:
measure: patient satisfaction for scar
timeFrame: six months
measure: any complications
timeFrame: six months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dr Ruth KM Pfau civil hospital karachi
state: Sindh
Study officials:
References: