louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04829071: Cognition and Motor Learning Post-stroke
Official title: Cognition as a Moderator of Motor Learning Post-stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Stroke
CVA (Cerebrovascular Accident)
Keywords: stroke
walking
rehabilitation
cognition
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 65
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This project seeks to determine how post-stroke cognitive impairment moderates motor learning during walking in older adults with chronic stroke and identify brain structural markers that mediate this relationship. The chosen experimental design integrates biomechanical analyses, neuropsychological assessments, and brain imaging techniques to determine the impact of post-stroke cognitive impairment severity on two forms of motor learning (explicit and implicit) and examine the role of the dorsolateral prefrontal cortex in the relationship between cognition and explicit motor learning. Ultimately, this work may lead to the development of a more comprehensive, effective treatment approach to improve walking dysfunction in older adults post-stroke.


Eligibility criteria: Inclusion Criteria:

* Unilateral stroke
* Stroke occurred more than 6 months prior
* Paresis confined to one side
* Independently ambulatory (including the use of assistive devices)
* Able to walk for 5 minutes without stopping
* Answers no to all general health questions on the PAR-Q+
* Willingness to complete study procedures

Exclusion Criteria:

* Brainstem or cerebellar stroke
* Aphasia (expressive, receptive, or global)
* Any major musculoskeletal or non-stroke neurological condition that interferes with the assessment of sensorimotor or cognitive function
* Metal in the head (except in the mouth), implanted cranial or thoracic devices that violate MRI safety regulations
* Uncontrolled hypertension (\>160/110mmHg)
* Concurrent physical therapy
* Claustrophobia
* Significant cognitive deficit or dementia (\<20 on MoCA)
* Inability to give informed consent

Primary outcomes:
measure: step length asymmetry - change in performance
timeFrame: Measured at three timepoints of interest within each testing session: baseline and at the beginning and end of the interventions; participants will complete 2 testing sessions over approximately 1 months
Secondary outcomes:
measure: step length asymmetry - immediate retention
timeFrame: Measured after motor learning in each testing session; participants will complete 2 testing sessions over approximately 1 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Center for Health Professions
state: California
Study officials:
affiliation: University of Southern California
name: Kristan Leech, PT, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01434771: Monitoring Blood Flow and Breathing Using a New Device (RFII) Compared to the Gold Standard Device in Post Operative Cardiac Patients
Official title: Simultaneous Hemodynamic and Ventilatory Monitoring Using Radio Frequency Impedance Interrogation (RFII), Thoracic Impedance Cardiography and Invasive Hemodynamic Monitoring Methods in Post Operative Cardiac Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Noninvasive Cardiac Monitoring
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Noninvasive Medical Technologies, Inc.
name: United States Department of Defense
First posted: 2011-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for open heart surgery

Brief summary: The purpose of this study will be to compare standard of care invasive methods to an FDA approved non-invasive device and a novel wireless non-invasive device, both manufactured by Non-Invasive Medical Technologies Inc., with the goal of correlating the data generated by the novel device to the measurements taken by the standard of care invasive monitors.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Weight - 36-136 Kilograms
* Height - 1.52 meters - 1.92 meters (5'- 6'4")
* Scheduled for open heart surgery during the study period

Exclusion Criteria:

* ECG lead adhesive allergy or sensitivity
* Pregnant Patients
* Prisoners
* Cognitively impaired
* Patients requiring mechanical cardiac support, or requirement for hemodialysis
* Patients not requiring pulmonary artery catheters for medical management.
* Patients with significant valvular disease will be enrolled if there is no significant post-repair valvular dysfunction as determined by intraoperative transesophageal echocardiography

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Kevin L Ferguson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05523271: A Multi Center Study Comparing the Efficacy of CAD EYE and the Standard of Care (White Light )
Official title: A Multi-center Control Study to Determine the Efficacy of CADEYE in Detecting Colon Polyps in Comparison to Standard of Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer screening
Lead sponsor: Theodor Bilharz Research Institute
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 1000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is to assess the sensitivity and added benefits of CADEYE compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.

Detailed description: Failure in polyp recognition is a major determinant for the high rate of missed colorectal neoplasms. In response, technological advances have paved the way for Computer-Aided Polyp Detection (CAD-e) systems. Artificial intelligence systems allow of real-time computer- aided detection of polyps with high-accuracy. CADEYE is a CAD-e system (FUJIFILM) that enables real-time video processing at the same rate as the standard procedure.

The data generated from this study will provide an estimate of the ADR throughout the Middle East as well as assess the accuracy of CADEYE in detecting adenomas in comparison to standard of care.

Eligibility criteria: Inclusion Criteria:

* 40-80 years old subjects
* Subjects undergoing colonoscopy for the following: o Primary CRC screening

  * Post-polypectomy surveillance
  * Work up following FIT positivity
  * Symptoms/signs suspicions of CRC
* Subjects must be willing to give written informed consent for the trial

Exclusion Criteria:

* Unable to consent
* Contraindicated to undergo endoscopy
* Hospitalized patient
* Patients with the following conditions:

  * History of colon resection
  * History of CRC
  * Antithrombotic therapy precluding colon resection o Inflammatory Bowel Disease (IBD)
  * Familial Adenomatous Polyposis (FAP)
* Pregnant or lactating
* Poor bowel preparation: BBPS 0 or 1 in a segment

Primary outcomes:
measure: Adenoma detection rate
timeFrame: 1 year
Secondary outcomes:
measure: Adenomas detected per colonoscopy
timeFrame: 1 year
measure: Proximal Adenoma detection rate
timeFrame: 1 year
measure: Withdrawal time
timeFrame: 1 year
measure: Non-neoplastic detection rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Theodor Bilharz Research Institute
Study officials:
References:
Clinical trial NCT01571271: Electrohydraulic Versus Laser Lithotripsy for Treatment of Difficult to Remove Biliary Stones
Official title: Electrohydraulic Versus Laser Lithotripsy for Treatment of Difficult to Remove Biliary Stones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gall Stones
Keywords: biliary
lithotripsy
gall stones
bile duct
Biliary stones
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2012-04-05
Enrollment: 25
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: Bile duct stones that can't be removed by conventional means can often be removed after fragmentation by shock waves (lithotripsy). The shock waves that are used for fragmentation of these stones are generated by electric sparks (electrohydraulic lithotripsy) or laser (laser lithotripsy). Although both techniques have been used for many years, there are no studies comparing the efficacy of the two. The purpose of this study is to find out which technique is more effective.

Detailed description: Procedures will be considered standard of care; patients or insurance companies will be billed as it is standard of care.

Eligibility criteria: Inclusion Criteria:

* 1 or more gall stones in bile duct which cannot be removed using conventional methods (must be fragmented)
* Adults able to provide informed consent

Exclusion Criteria:

* Pregnancy or lactation

Primary outcomes:
measure: Time
timeFrame: Procudre duration
Secondary outcomes:
measure: Number of shocks
timeFrame: Procedure duration
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Mansour A. Parsi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02348671: Evaluation of Wound Dressings in the Reduction of Shear- Force
Official title: Evaluation of Wound Dressings to Reduce the Harmful Effects of Shear- Force at the Skin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pressure Ulcer
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2015-01-28
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ten healthy volunteers

Brief summary: The purpose of this study is to investigate if wound dressings are capable in reducing the effects of shear- force at the skin. With our own shear- force model we are able to apply 19 Newton shear- force combined with 9 newton pressure at the skin of the non- dominant forearm. After half an hour we measure IL-1alpha/ total protein- ratio, cutaneous blood flow (Laser doppler, Moor LDI) and the erythema index (DSMIIColormeter) which occurs as an effect of shear- force application at the skin.

Then, we apply 19 Newton shear- force combined with 9 Newton pressure at the dominant fore-arm but this time we put a wound dressing between the skin and shear- force model. After half an hour we measure the IL-1alpha/total protein-ratio, cutaneous blood flow and the erythema index.

This research consists of three research day, each day we are going to investigate a different wound dressing


Eligibility criteria: Inclusion Criteria:

* healhty volunteer
* age 18- 30
* BMI 20- 30

Exclusion Criteria:

* Trauma fore-arms
* Diabetes mellitus type I or type II
* The use of NSAID's in the last 7 days
* Vascular diseases
* Muscular dystrophy
* Malignancy
* Participant is unable to give informed consent

Primary outcomes:
measure: Cutaneous blood flow, erythema index, IL-1alpha/Total protein ratio
timeFrame: Directly after intevention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06026488: Real-World Study of DLBCL With Different Genetic Subtypes
Official title: A Real-World Study of Diffuse Large B-Cell Lymphoma (DLBCL) Patients With Different Genetic Subtypes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: DLBCL - Diffuse Large B Cell Lymphoma
Lymphoma
Keywords: lymphoma
DLBCL
Genetic Subtype
real world analysis
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: DLBCL patients with genetic subtypes belonging to one of the seven subtypes by NGS: MCD, BN2, N1, ST2, A53, EZB (MYC+, MYC-) and others

Brief summary: To collect and evaluate the data of real-world treatment regimen, efficacy, safety and survival information of DLBCL patients with different genetic suptypes

Detailed description: DLBCL is a highly common malignant tumor in Asia. The aim of the study is to observe and explore the clinical information on DLBCL patients with different genetic subtypes and to analyze the clinical characteristics and prognosis of different molecular subtypes of DLBCL. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors. The results can guide future precision therapy for DLBCL.

Eligibility criteria: Inclusion Criteria:

* Histologically-confirmed diffuse large B-cell lymphoma (DLBCL)
* Genetic subtype belonging to at least one of the seven subtypes by using next generation sequencing: MCD, BN2, N1, ST2, A53, EZB (MYC+, MYC-) and others
* Fully comprehension and signature of the informed consent form (ICF) for participation

Exclusion Criteria:

* Those who refuse to use reliable methods of contraception during pregnancy, lactation or age-appropriate period
* Severe mental illness
* Patients deemed unsuitable for inclusion by the investigator

Primary outcomes:
measure: PFS
timeFrame: Baseline up to data cut-off (Up to approximately 9 years)
Secondary outcomes:
measure: ORR
timeFrame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
measure: CRR
timeFrame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
measure: OS
timeFrame: Baseline up to data cut-off (Up to approximately 9 years)
measure: DOR
timeFrame: Baseline up to data cut-off (Up to approximately 9 years)
measure: TTR
timeFrame: Approximately up to 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT02589288: Adductor Canal Block: Continuous Infusion Versus Automatic Intermittent Bolus
Official title: Adductor Canal Block: Continuous Infusion Versus Automatic Intermittent Bolus For Postoperative Analgesia After Day-Case Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury of Anterior Cruciate Ligament
Lead sponsor: ASST Gaetano Pini-CTO
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 80
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 aim of this prospective, randomized , blinded study is to compare two different infusion techniques (continuous VS intermittent automatic bolus) to assess the effects of postoperative analgesia after Day-Case anterior cruciate ligament (ACL) reconstruction.


Eligibility criteria: Inclusion Criteria:

* Age above 18 years old
* American society of anesthesiology (ASA) physical status I-II
* Signed informed consensus

Exclusion Criteria:

* ASA \>II
* Unstable neurological disease
* Diabetic mellitus (DM) type I-II
* Allergy to used drugs
* Opioid chronic treatment
* Consensus refusal or not valid
* Anticoagulant therapy
* Postoperative intensive care required

Primary outcomes:
measure: NRS Score
timeFrame: 72h postoperative
Secondary outcomes:
measure: Up and Go test
timeFrame: 72h postoperative
measure: Opioids request
timeFrame: 72h postoperative
measure: Local anesthetic consumption
timeFrame: 72h postoperative
measure: 10mt walk test
timeFrame: 72h postoperative
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto ortopedico Gaetano Pini
Study officials:
affiliation: Study Principal Investigator
name: Gianluca Cappelleri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05847088: Intravitreal Dexamethasone Implant for Refractory Diabetic Macular Edema:
Official title: Intravitreal Dexamethasone Implant for Refractory Diabetic Macular Edema: Anatomical and Functional Outcomes of Treatment and Retreatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Lead sponsor: Dar El Oyoun Hospital
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 58
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective Review of records of patients with Non-tractional diffuse diabetic macular edema (NTDME), for whom Ozurdex had been used , in the period between 2016 and 2022.

Brief summary: We have been using DEX for refractory DME for a long time (since 2016). Thus, we are sharing our results , evaluating both anatomical and functional outcomes of DEX therapy for refractory DME.

Detailed description: Our study aims at evaluating both anatomical and functional outcomes of DEX therapy for cases of refractory DME, with both a single injection, and /or with retreatments.

Eligibility criteria: Inclusion Criteria:

* • Age: 16 or older (Adults)

  * Sex: both
  * NTDME with CMT \>300 u
  * \< 10% reduction in CMT (than previous treatment)
  * \< 50 u reduction in CMT (than previous treatment)
  * Worsening of BCVA \> 1 line on E chart.
  * Duration since Previous treatment is: 3 months with DEX, 1 month with Anti-VEGF
  * Pseudophakic eyes
  * NPDR , PRP-treated PDR

Exclusion Criteria:

* • Phakic eyes

  * Uncontrolled Glaucoma (IOP \> 24 mmHg, or cup disc ratio 0.8 or more)
  * Herpetic viral infection.
  * Untreated PDR

Primary outcomes:
measure: Change in Central macular thickness (in microns) (CMT change )
timeFrame: between baseline and 6 months
measure: Change in Best corrected visual acuity (BCVA change) )
timeFrame: between baseline and 6 months
Secondary outcomes:
measure: Number of DEX injections
timeFrame: between baseline and 6 months
measure: Shift to anti-VEGF during follow-up
timeFrame: between baseline and 6 months
measure: Duration of follow-up ( months)
timeFrame: between baseline and 6 months
measure: CMT change > 100 u
timeFrame: between baseline and 6 months
measure: CMT change > 200 u
timeFrame: between baseline and 6 months
measure: BCVA change >= 2 lines
timeFrame: between baseline and 6 months
measure: Complications : ocular hypertension, pseudo uveitis, endophthalmitis, RD
timeFrame: between baseline and 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr alainy faculty of medicine
Study officials:
References:
Clinical trial NCT02853188: Measure of Plasma Tissue Factor to Predict a Venous Thromboembolism in Primitive Cancer of Lung
Official title: Does the Measure of the Plasma Tissue Factor Allow to Predict a Venous Thromboembolism Episode for Patients Presenting a Primitive Lung Cancer?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Lung
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of the study is to evaluate if the plasma activity of the tissue factor at the time of the diagnosis of a lung cancer, before any treatment, or after the treatment of induction (surgery or two first cures of chemotherapy), can be a predictive factor of venous thromboembolism disease in the year which follows the diagnosis, independently of the other parameters.


Eligibility criteria: Inclusion Criteria:

* Patients of more than 18 years old
* Patients with cancer of lung diagnosis carried for less than 2 months and which were not handled yet, either by surgery or by chemotherapy, or by radiotherapy
* Patients whose life expectancy is considered 3-month-old a superior
* Patients having given writed consent
* Patients affiliated to a national insurance scheme or benefiting from such a diet
* Patients having received a treatment (processing) anticoagulating in preventive dose if this treatment was stopped at least 3 days before the 1st taking or patients not receiving an anticoagulating treatment (in case of curative treatment, the latter was before arrested at least 3 months

Exclusion Criteria:

* Patients having a hepatic disease with coagulation disorders
* Patients under anticoagulants with dose guardian in 3 months preceding the study or presenting an active infection
* Patients having a history of other cancer considered as cured and diagnosed for less than 5 years (with the exception of the patients operated for an in situ carcinoma of the neck of the womb or the patients having undergone the excision of a squamous-cell carcinoma)

Primary outcomes:
measure: Venous thromboembolism occurence
timeFrame: 2 years
measure: Tissue factor
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Creteil
country: France
facility: Centre hospitalier intercommunal de Créteil
city: Le Chesnay
country: France
facility: Centre hospitalier de Versailles
city: Paris
country: France
facility: : Institut Mutualiste Montsouris
city: Paris
country: France
facility: AP-HP Hôpital Européen Georges Pompidou
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopitak Foch
name: Marc VASSE, PhD
role: STUDY_DIRECTOR
References: