louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05638464: Multisite Transcranial Direct Current Stimulation to Promote Hand Function Recovery After Stroke
Official title: Multisite Transcranial Direct Current Stimulation Targeting Motor Network by Mapping Electric Fields With Task-based fMRI to Promote Hand Function Recovery After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 50
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 novel multisite high definition tDCS (HD-tDCS) in healthy people showed that such network-targeted stimulation could enhance motor excitability beyond traditional stimulation which targeting only one region. It showed that the excitability following multisite HD-tDCS was more than double the increase following conventional tDCS. To consider the various lesion site of different stroke survivors. The electrode placements based on personalized lesion profiles and anatomical features can be determined using finite element modeling, with lesion profiles generated from fMRI and advanced algorithms calculating the current density to maximize the modulation effect. Combining motor network interaction and the new multisite electrode montage may further provide a potential to facilitate stroke recovery.


Eligibility criteria: Inclusion Criteria:

* first-ever stroke, the duration after stroke exceeds 12 months;
* mild to moderate upper extremity motor function deficit, determined by the Fugl-meyer assessment of upper extremity (FMAUE) scores between 15 and 53;
* detectable voluntary muscle sEMG signal from flexor digitorum (FD) and extensor digitorum (ED);
* scored below 3 in the Modified Ashworh Score (MAS) of FD and ED;
* sufficient cognitive function to follow the assessment and training instructions, determined by Mini Mental State Examination score of more than 21.

Exclusion Criteria:

* history of epilepsy, or any other contradictions of brain stimulation;
* severe joint contracture of elbow or shoulder, or pain induced by any other neurological, neuromuscular, and orthopedic diseases.

Primary outcomes:
measure: Fugl-Meyer Assessment Upper Extremity
timeFrame: 6-month after intervention
Secondary outcomes:
measure: Action Research Arm Test
timeFrame: 6-month after intervention
measure: Magnetic Resonance Imaging (MRI)
timeFrame: 6-month after intervention
measure: Electroencephalography (EEG)
timeFrame: 6-month after intervention
measure: Electromyography (EMG)
timeFrame: 6-month after intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Biomedical Engineering, The Chinese University of Hong Kong
Study officials:
affiliation: Department of Biomedical Engineering, CUHK
name: Raymond Kai-yu Tong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06852664: Improving Activity in Individuals With Cerebral Palsy
Official title: Improving Activity in Individuals With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Fitbit
Mobility
Steps
Lead sponsor: Father Flanagan's Boys' Home
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 32
Sex: ALL
Minimum age (years): 11
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cerebral Palsy participants will undergo baseline mobility/brain imaging/cognitive testing, receive motivational interviewing, and then repeat mobility/brain imaging testing.
Primary purpose: TREATMENT

Brief summary: Individuals with cerebral palsy are known to have a reduced amount of physical activity; yet, there are no known intervention strategies for improving the number of steps they take each day. This study will use wearable physical activity monitors to assess if behavioral coaching is a viable strategy for combating the reduced physical activity seen in this patient population.

Detailed description: A lack of physical activity in persons with cerebral palsy is known to have cascading effects on their overall health. Despite this recognition, there have been limited attempts to improve the physical activity of this patient population. The overall landscape of this project is that a cohort of persons with cerebral palsy will undergo 8 weeks of physical activity that is guided by behavioral coaching. This study aims to determine the impact of behavioral coaching on 1) the amount of daily physical activity, 2) changes in the sensorimotor cortical activity, 3) changes in laboratory assessments of functional mobility. The participants with CP will initially undergo neuroimaging and a battery of clinical assessments. After completing the baseline tests, the participants will undergo 8-weeks of behavioral coaching where they are encouraged to increase the number of steps they take per-day. After completing the 8 weeks, the participants will repeat the same assessments that were performed at baseline.

Eligibility criteria: Inclusion Criteria:

* Cerebral palsy diagnosis and ambulatory (Gross Motor Function Classification Score \[GMFCS\] levels between I-III).

Exclusion Criteria:

* No orthopedic surgery in the last 6 months, botulinum injections within the last 6 months, or metal in their body that would preclude the use of MEG.

Primary outcomes:
measure: Change in Mobility Test Time
timeFrame: Baseline and 8 weeks
measure: Change in Time in 5 Times Sit-to-Stand
timeFrame: Baseline and 8 weeks
measure: Change in Time for Timed Up and Go
timeFrame: Baseline and 8 weeks
measure: Changes in Brain Activity
timeFrame: Baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boys Town
country: United States
facility: Boys Town National Research Hospital
state: Nebraska
Study officials:
References:
Clinical trial NCT05418764: Effect of Validated Skills Simulation With the Miya Model
Official title: Effect of Validated Skills Simulation With the Miya Model on Operating Room Performance of Vaginal Hysterectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vaginal Hysterectomy
Keywords: vaginal surgery techniques
gynecological procedures
mid-urethral slings (MUS)
simulation training
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study participants will be residents at participating institutions who agree to participate in the study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Simulation training with the Miya Model will improve Operating Room performance of Vaginal Hysterectomy (VH) in novice surgeons and this phase of the study is designed to test that.

Detailed description: Vaginal Hysterectomy (VH) is the desired hysterectomy technique of The American College of Obstetricians and Gynecologists (ACOG) since it is associated with less morbidity, quicker recovery and lower costs than laparoscopic and abdominal hysterectomy. Despite its well documented advantages, numbers nationwide in the US are declining. Of all minimally invasive hysterectomy procedures, the vaginal approach has been the only one demonstrating a consistent decrease in use from 25% of cases in 1998 to 17% of cases in 2010. A large part of this is due to inadequate training for this technique. There currently is no standardized curriculum for teaching VH, and training varies widely between residency programs. It is widely held that simulation training for surgical procedures improves outcome, but there is a need to validate this for vaginal surgery training.

Eligibility criteria: Inclusion Criteria:

* residents at participating Institutions
* residents have performed ten or fewer vaginal hysterectomies

Exclusion Criteria:

* having had prior training dedicated to vaginal hysterectomy
* having performed eleven or more vaginal hysterectomies in the OR

Primary outcomes:
measure: Vaginal Surgical Skills Index (VSSI) scores - Control Group
timeFrame: Month 2
measure: Vaginal Surgical Skills Index (VSSI) scores - Intervention Group
timeFrame: Month 2
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Leslie Kammire, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02025764: The Clinical Feature of Ulcer Base Over Time After Prophylactic Argon Plasma Coagulation in Colonic EMR
Official title: The Clinical Feature of the Exposed Vessels in Ulcer Base Over Time After Prophylactic Argon Plasma Coagulation in Colonic Endoscopic Mucosal Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Hemorrhage
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Between August 2013 and May 2014, patients who were enrolled underwent prophylactic APC for non-bleeding visible vessels after colonic endoscopic mucosal resection.

Brief summary: The prophylactic APC right after colonic EMR doesn't mean the complete coagulation of visible vessel because of injection material.

The aim of this study was to evaluate the clinical feature of the visible vessels in ulcer base over time after prophylactic APC in colonic EMR.

Detailed description: The prophylactic Argon plasma coagulation (APC) of non-bleeding visible vessels seems not to have an additional advantage in the prevention of delayed post polypectomy bleeding in recently studies. However, immediate APC after endoscopic mucosal resection (EMR) may not mean the complete coagulation of exposed vessels because of injection material. The aim of this study was to evaluate the clinical feature of the exposed vessels in ulcer base over time after prophylactic APC in colonic EMR. Methods: This study was designed as a prospective study. Investigators excluded diminutive polyp, large polyp (\> 2cm), long stalk pedunculated polyp, and clear ulcer base after EMR. Between August 2013 and May 2014, patients who were enrolled underwent prophylactic APC for non-bleeding visible vessels after colonic endoscopic mucosal resection. After checking the complete coagulation of visible vessels, the numbers of visible vessel group were counted by lap of time such as 1, 3, 5, and 7 min in ulcer base.

Eligibility criteria: Inclusion Criteria:

* Underwent prophylactic APC for non-bleeding visible vessels after colonic endoscopic mucosal resection.

Exclusion Criteria:

* Diminutive polyp, large polyp (\> 2cm), long stalk pedunculated polyp, and clear ulcer base after EMR.

Primary outcomes:
measure: underwent prophylactic APC for non-bleeding visible vessels after colonic endoscopic mucosal resection. After checking the complete coagulation of visible vessels, the numbers of visible vessel group were counted in ulcer base.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
state: Chungcheonam-do
Study officials:
affiliation: Soo Chun Hyang University Hospital Cheonan
name: Yunho Jung, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01478464: Effect of Massage on Hamstring Muscle Soreness
Official title: Danish: Integreret Motion på Arbejdspladsen (IRMA) English: Implementation of Exercise at the Workplace
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Disorders
Lead sponsor: National Research Centre for the Working Environment, Denmark
Sponsor class: OTHER_GOV
First posted: 2011-11-23
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Delayed onset muscular soreness peaks in 24-48 hours after unaccustomed strenuous physical exercise. Therapists often provide manual massage with the hands to acutely relief the soreness. Alternatives to manual hand massage can be useful for therapists. Here the investigators examine the acute effect of a "massage roller" on DOMS in the hamstring muscles


Eligibility criteria: Inclusion Criteria:

* working age adults

Exclusion Criteria:

* blood pressure above 160/100
* disease of the cervical spine

Primary outcomes:
measure: Perceived soreness on a scale of 0-10
timeFrame: change from before to after massage (average of 0, 10, 30 and 60 min after)
Secondary outcomes:
measure: Pressure pain threshold (PPT) of the hamstring muscles
timeFrame: change from before to after massage (average of 0, 10, 30 and 60 min after)
measure: Hamstring range of motion
timeFrame: change from before to after massage (average of 0, 10, 30 and 60 min after)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: National Research Centre for the Working Environment
Study officials:
affiliation: Professor
name: Lars L Andersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01093664: Safety/Tolerability, Immunological and Clinical Activity of a Boost Immunization With AFFITOPE AD02
Official title: Phase IB Follow-up Study to Assess a Boost Immunization With AFFITOPE AD02 With Regard to Safety/Tolerability, Immunological and Clinical Activity in Alzheimer Patients Who Have Received the Vaccine Within the Clinical Study AFF002
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Affiris AG
Sponsor class: INDUSTRY
First posted: 2010-03-26
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase IB follow-up study to assess a boost immunization with AFFITOPE AD02 with regard to safety/tolerability, immunological and clinical activity in Alzheimer patients who have received the vaccine within the clinical study AFF002.


Eligibility criteria: Inclusion Criteria:

* Participation in AFF002 and AFF004

Exclusion Criteria:

* Presence or history of allergy to components of the vaccine, if considered relevant by the investigator
* Contraindication for MRI imaging
* History and/or presence of autoimmune disease, if considered relevant by the investigator
* Active infectious disease (e.g., Hepatitis B, C)
* Presence and/or history of Immunodeficiency (e.g., HIV)
* Significant systemic illness

Primary outcomes:
measure: Safety and Tolerability
timeFrame: July 2010
Secondary outcomes:
measure: Immunological and clinical activity
timeFrame: July 2010
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Ordination Schmitz
Study officials:
affiliation: Ordination Schmitz
name: Margot Schmitz, Univ. Doz.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04071964: Gut Microbiota, Anastomotic Leak and Colorectal Cancer
Official title: Gut Microbiota, Anastomotic Leak and Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Cancer
Keywords: Microbiota
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with colorectal cancer undergoing surgical resection (or expectative management for rectal cancer after complete clinical response to chemoradiotherapy)

Brief summary: This is a prospective study evaluating the relation between the gut microbiota composition, intestinal healing after colorectal surgery and colorectal cancer behavior.

Our hypothesis is that the gut microbiota composition could predict poor intestinal healing in colorectal surgery, and that the gut microbiota might have an impact on colorectal cancer clinical behavior and may predict disease outcomes.

Detailed description: No more details required

Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* CRC diagnosis
* Upcoming colonic and/or rectal resection with/without anastomosis
* Individuals without diseases of the colon and rectum (healthy controls)

Exclusion Criteria:

* Pregnancy
* Previous stoma
* Bowel surgery in the last 4 weeks prior to the surgery

Secondary objectives, inclusion criteria are as follows:

* Age 18 years and older
* Rectal cancer diagnosis with histopathological confirmation
* Abdominoperineal resection with terminal colostomy
* Expectative non-surgical management ("Watch and wait approach")

Primary outcomes:
measure: Number of participants with an anastomotic leak
timeFrame: 1 month
Secondary outcomes:
measure: Number of participants with cancer reoccurence
timeFrame: 3 years
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre hospitalier de l'Université de Montréal
state: Quebec
Study officials:
References:
Clinical trial NCT02602964: A Trial Comparing Deep Versus Moderate Neuromuscular Block - in Low Pressure Pneumoperitoneum
Official title: A Randomized Controlled Trial Comparing Deep Versus Moderate Neuromuscular Block - in Low Pressure Pneumoperitoneum - to Optimize the Surgical Conditions During Laparoscopic Donor Nephrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nephrostomy; Complications
Pneumoperitoneum
Observation of Neuromuscular Block
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
First posted: 2015-11-11
Enrollment: 34
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: Live kidney transplantation is first choice for patients with end-stage kidney disease. Therefore, the safety and well-being of kidneys donors are highly important objectives in live kidney donation. Low pressure pneumoperitoneum can decrease postoperative pain and therefore also concomitant use of opioids.

Detailed description: However low pressure pneumoperitoneum can also decrease peri-operative conditions. In this trial the researchers will investigate whether peri-operative conditions during low pressure pneumoperitoneum can be optimized by the use of deep neuromuscular block.

Eligibility criteria: Inclusion Criteria:

* obtained informed consent
* age over 18 years

Exclusion Criteria:

* chronic use of analgesics or psychotropic drugs
* use of non-steroidal anti-inflammatory drugs shorter than 5 days before surgery
* known or suspect allergy to rocuronium or sugammadex
* significant liver or renal dysfunction
* pregnant or breastfeeding

Primary outcomes:
measure: Mean surgical rating score
timeFrame: perioperative
Secondary outcomes:
measure: Conversion to standard pressure pneumoperitoneum
timeFrame: perioperative
measure: Intra-operative complications
timeFrame: perioperative
measure: Length of pneumoperitoneum
timeFrame: perioperative
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
Study officials:
affiliation: Radboud University Medical Center
name: Denise Özdemir-van Brunschot, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reijnders-Boerboom GTJA, van Helden EV, Minnee RC, Albers KI, Bruintjes MHD, Dahan A, Martini CH, d'Ancona FCH, Scheffer GJ, Keijzer C, Warle MC. Deep neuromuscular block reduces the incidence of intra-operative complications during laparoscopic donor nephrectomy: a pooled analysis of randomized controlled trials. Perioper Med (Lond). 2021 Dec 9;10(1):56. doi: 10.1186/s13741-021-00224-1.
citation: Ozdemir-van Brunschot DMD, Braat AE, van der Jagt MFP, Scheffer GJ, Martini CH, Langenhuijsen JF, Dam RE, Huurman VA, Lam D, d'Ancona FC, Dahan A, Warle MC. Deep neuromuscular blockade improves surgical conditions during low-pressure pneumoperitoneum laparoscopic donor nephrectomy. Surg Endosc. 2018 Jan;32(1):245-251. doi: 10.1007/s00464-017-5670-2. Epub 2017 Jun 22.
Clinical trial NCT03098264: Safety and Efficacy of Simultaneous or Staged Surgery on Complicated Hepatolithiasis
Official title: A Cohort Study on Safety and Efficacy of Simultaneous or Staged Surgery in Complicated Hepatolithiasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatolithiasis
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Chinese PLA General Hospital
name: Eastern Hepatobiliary Surgery Hospital
name: First Affiliated Hospital of Zhongshan Medical University
name: Air Force Military Medical University, China
name: Huaxi Hospital
name: Tongji Hospital
name: Union hospital of Fujian Medical University
First posted: 2017-03-31
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For some complicated hepatolithiasis, it is difficult to decide whether to perform surgery on biliary stone and portal hypertension simultaneously or separately by staged surgery.There's a high risk of intraoperative bleeding, postoperative liver failure and variceal bleeding for these patients.How to develop a optimized algorism of simultaneous and staged surgery is highly needed.

Detailed description: For some complicated hepatolithiasis, it is difficult to decide whether to perform surgery on biliary stone and portal hypertension simultaneously or separately by staged surgery.There's a high risk of intraoperative bleeding, postoperative liver failure and variceal bleeding for these patients.How to develop a optimized algorism of simultaneous and staged surgery is highly needed. In this protocol, we will assign the eligible cases into two group. And then perform surgery as simultaneously or separately.By long-term follow-up,to examine the safety and advantages of each procedure.

Eligibility criteria: Inclusion Criteria:

* Aged from 18 to 65 years old
* Without gender restriction
* With a favorable liver function of Child-Pugh A to B
* No contraindications to surgery and anesthesia
* Diagnosed with Hepatolithiasis and portal hypertension
* Signed informed consent.

Exclusion Criteria:

* Diffused type of Hepatolithiasis
* Impairment in liver function
* Severe disorders in vital organ
* Accompanied with tumors.

Primary outcomes:
measure: residual ratio of biliary stone
timeFrame: 3 months
Secondary outcomes:
measure: postoperative complications
timeFrame: 6 months
measure: residual lesions
timeFrame: 6 months
measure: Health economics index
timeFrame: 3 months
measure: mortality
timeFrame: 3 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
Study officials:
References: