louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05996198: Exoskeletal Support in Stroke
Official title: A Pilot Proof of Concept, Single Site Study to Assess the Effect of Exoskeletal Support on Motor Control Strategies in Individuals With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This interventional study will measure motor performance, including 3D movement analysis and muscle activity, in response to exoskeleton assistance. The cohort design will compare stroke patients to healthy controls. Data collection will be conducted in a single, 2-hour session. Investigators will also access stroke patients' brain MRIs that were obtained as standard of care during acute admission for stroke.


Eligibility criteria: Inclusion Criteria:

Healthy controls:

* Having obtained the age of 18 years
* Neurologically healthy (i.e., no history of: traumatic brain injury, peripheral neuropathy, seizures, etc.)
* Strongly right-handed according to at least 80% score on the Edinburgh Handedness Inventory (Oldfield, 1971; Veale, 2013). The use of right-handed participants is a common feature in this field of study. This is due to the slight differences in arm control between left- and right-handed individuals (Sainburg \& Kalakanis, 2000).
* Ability to give informed consent

Survivors of stroke:

* Having obtained the age of 18 years
* have a diagnosis of stroke more than six months prior to entry into the study;
* have the ability to reach, unsupported, to approximately 70% of arm length
* ability to give informed consent

Exclusion Criteria:

All participants

* have any conditions that limit their capability of using a Head Mounted Display (HMD) for a VR environment or cooperate with the protocol.
* have any orthopedic injuries to the upper extremities.
* Have neurological injuries other than stroke.
* Have excessive pain in any joint of either arm that could limit the ability to cooperate with the protocols.
* Visuospatial neglect
* Apraxia
* Global inattention
* Legal blindness

Primary outcomes:
measure: Relative Contribution (RC)
timeFrame: End of VR Task (Day 1 - session lasts approx. 2 hours)
measure: Muscle Contribution (MC)
timeFrame: Baseline, End of VR Task (Day 1 - session lasts approx. 2 hours)
Secondary outcomes:
measure: Corticospinal Tract (CST) Lesion Load
timeFrame: Baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health (222 East 41st Street)
state: New York
Study officials:
affiliation: NYU Langone Health
name: Heidi Schambra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06746298: A Prospective Study of Expression Profiling-based Assessment of the Efficacy of Neoadjuvant Therapy for Rectal Cancer
Official title: A Prospective Study of Expression Profiling-based Assessment of the Efficacy of Neoadjuvant Therapy for Rectal Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rectal Cancer
Neoadjuvant Therapy
Lead sponsor: Shanghai Minimally Invasive Surgery Center
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 118
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: Rectal cancer patients intended for neoadjuvant therapy

Brief summary: This is a prospective study of expression profiling-based assessment of the efficacy of neoadjuvant therapy for rectal cancer.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years, male or infertile female
* Patients with rectal adenocarcinoma diagnosed by colonoscopic biopsy
* Neoadjuvant therapy according to guideline recommendations
* Endoscopic biopsy with access to biopsy tissue for subsequent RNA-seq testing
* Patients who do not have a combination of primary malignant tumors elsewhere.
* Patients who understand the purpose of the trial, participate voluntarily and sign an informed consent form.

Exclusion Criteria:

* Samples are not collected, stored, or processed in accordance with specified requirements
* Sample does not meet the requirements for subsequent RNA-seq testing
* Cases enrolled with a subsequent diagnosis other than rectal adenocarcinoma.
* The patient refuses or is unable to complete the entire neoadjuvant treatment
* Lack of post-neoadjuvant imaging results and lack of routine postoperative pathology results.
* Other patients who, in the judgment of the investigator, do not meet the enrollment requirements

Primary outcomes:
measure: Objective Response Rate
timeFrame: From the start of the neoadjuvant therapy until just before surgery
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
measure: Progression free survival
timeFrame: 3 years
measure: Total resection rate
timeFrame: One month after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01548898: The Efficacy of Laser Assisted Hair Removal in the Treatment of Acne Keloidalis Nuchae; a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Keloidalis Nuchae
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Laser causes elimination and miniaturization of hair shafts that are the principal contributor to inflammation in Acne Keloidalis Nuchae (AKN).


Eligibility criteria: Inclusion Criteria:

* patients suffering from AKN

Primary outcomes:
measure: Global response to treatment
timeFrame: 6 months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04337398: Exercise in Severe Mental Illness. The PsychiActive Project 2.0
Official title: Feasibility, Adherence and Effects of Two Exercise-based Interventions in Adults With Severe Mental Illness. The PsychiActive Project 2.0
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exercise Therapy
Severe Mental Illness
Keywords: Exercise
Severe Mental Illness
Adherence
Wearables
Activity Trackers
Exergames
Lead sponsor: Universidad Pablo de Olavide
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized controlled trial is to study the feasibility, adherence and effects of two exercise interventions on body weight, body composition, anthropometric and fasting blood measures, physical fitness, quality of life, and lifestyle habits in patients with severe mental illness.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of psychiatric disorder (ICD-10).
* Stabilized antipsychotic medication during the last month.

Exclusion Criteria:

* Clinical instability.
* Substance abuse.
* Comorbidities contraindicating.

Primary outcomes:
measure: Self-reported sedentary behavior
timeFrame: 12 weeks
measure: Self-reported physical activity
timeFrame: 12 weeks
measure: Behavioral Regulation in Exercise
timeFrame: 12 weeks
measure: Adherence
timeFrame: 12 weeks
measure: Dropout
timeFrame: 12 weeks
measure: Body weight
timeFrame: 12 weeks
measure: Fat mass
timeFrame: 12 weeks
measure: Lean mass
timeFrame: 12 weeks
measure: Waist circumference
timeFrame: 12 weeks
measure: Hip circumference
timeFrame: 12 weeks
measure: Health status
timeFrame: 12 weeks
measure: Quality of Life
timeFrame: 12 weeks
measure: Self-Reported Physical Fitness
timeFrame: 12 weeks
Secondary outcomes:
measure: Lower body strength
timeFrame: 12 weeks
measure: Upper body strength
timeFrame: 12 weeks
measure: Handgrip strength
timeFrame: 12 weeks
measure: Cardiorespiratory fitness
timeFrame: 12 weeks
measure: Lower body flexibility
timeFrame: 12 weeks
measure: Upper body flexibility
timeFrame: 12 weeks
measure: Mood
timeFrame: 12 weeks
measure: Psychopathological symptoms
timeFrame: 12 weeks
measure: Smoking
timeFrame: 12 weeks
measure: Blood glucose
timeFrame: 12 weeks
measure: Blood cholesterol
timeFrame: 12 weeks
measure: Blood triglyceride
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Álvaro López Moral
state: Andalucia
Study officials:
affiliation: Universidad Pablo de Olavide
name: Diego Munguía-Izquierdo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04285398: Prospective Natural History Study of Retinitis Pigmentosa
Official title: Natural History Study of Retinitis Pigmentosa Due to RHO, PDE6a or PDE6b Mutations
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Retinitis Pigmentosa
Keywords: RHO
PDE6A
PDE6B
Pathogenic Mutation
Prospective
Natural History
Retinal Disease
Eye Disease
Blindness
Inherited Eye Disease
Vision Disorder
Inherited Retinal Disorder
Rod-Cone Dystrophy
Lead sponsor: SparingVision
Sponsor class: INDUSTRY
First posted: 2020-02-26
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This is natural history study of rods and cones degenerations in patients with Retinitis Pigmentosa (RP) caused by pathogenic mutations in RHO, PDE6a or PDE6b gene mutations.

Detailed description: This is an open, longitudinal, prospective, multicentric study to describe the disease progression in patients with retinitis pigmentosa due to mutation in genes with selective expression in rods: rhodopsin (RHO), phosphodiesterase 6a (PDE6a) or phosphodiesterase 6b (PDE6b).RHO,PDE6A or PDE6B mutation.

Eligibility criteria: Inclusion Criteria:

* RP with mutations affecting the RHO, PDE6A and PDE6B genes
* Visual acuity ≥ 20/200 for at least one eye at inclusion visit
* Binocular Visual field diameter ≥ 5° as measured on the Goldmann III-4e isopter at inclusion visit
* Patients having signed the informed consent form
* Sufficient knowledge of the local language to ensure understanding of the tasks to be performed and the instructions received
* Patient affiliated to a Health Security System if they are included in a clinical site based in France (per law)

Exclusion Criteria:

* Patients with any other gene mutation known to be involved in RP
* Patients with other ocular disorder likely to impact the retinal function
* Pregnant or breastfeeding women

Primary outcomes:
measure: Spectral Domain Optical Coherence tomography (SD-OCT)
timeFrame: 1 year
measure: Fundus Autofluorescence (FAF)
timeFrame: 1 year
Secondary outcomes:
measure: Visual acuity
timeFrame: 1 year
measure: Visual field
timeFrame: 1 year
measure: Full-field stimulus threshold (FST)
timeFrame: 1 year
measure: Color vision
timeFrame: 1 year
measure: Dark adaptometry (DA)
timeFrame: 1 year
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Eye Center
state: Pennsylvania
city: Paris
country: France
facility: CHNO XV-XX Paris - CIC 1423
Study officials:
affiliation: CHNO XV-XX Paris - CIC 1423
name: Isabelle Audo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03004898: Population-based Chronic Kidney Disease Cohort at Northern Taiwan
Official title: Preventing Progression of Renal Disease by Multidisciplinary Education - A Cohort Study at Northern Taiwan.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease, Population, Community, Multidisciplinary, Education
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-12-29
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: CKD is a global endemic disease with increased comorbidities and mortality. The prevalence and the incidence of the end-stage renal disease (ESRD) are extremely high in Taiwan. The prevalence of CKD remains high; however, the awareness remains low. Screening of unique risk factor and early diagnosis of CKD can improve outcome. Furthermore, data of renal education deep into the community remains limited. The aims of this study are:

1. Explore risk factors associated with CKD in the community
2. Establish multidisciplinary care model in the community
3. Investigate mechanistic mediators for CKD and multidisciplinary education approached in behavioral , physiological, immune and metabolomics aspects
4. Provide bio-specimen repository for future study


Eligibility criteria: Inclusion Criteria:

* residents of Northern Taiwan

Exclusion Criteria:

* pregnancy women, unwilling to participate

Primary outcomes:
measure: eGFR < 60 mL/min
timeFrame: through study completion, every 1 year
measure: albuminuria/creatinine ratio >=30
timeFrame: through study completion, every 1 year
measure: proteinuria/creatine ratio >=150
timeFrame: through study completion, every 1 year
Secondary outcomes:
measure: SF-36
timeFrame: through study completion, every 1 year
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Department of Nephrology, Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: I-Wen Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu IW, Wang SY, Hsu KH, Lee CC, Sun CY, Tsai CJ, Wu MS. Multidisciplinary predialysis education decreases the incidence of dialysis and reduces mortality--a controlled cohort study based on the NKF/DOQI guidelines. Nephrol Dial Transplant. 2009 Nov;24(11):3426-33. doi: 10.1093/ndt/gfp259. Epub 2009 Jun 2.
citation: Chen SH, Tsai YF, Sun CY, Wu IW, Lee CC, Wu MS. The impact of self-management support on the progression of chronic kidney disease--a prospective randomized controlled trial. Nephrol Dial Transplant. 2011 Nov;26(11):3560-6. doi: 10.1093/ndt/gfr047. Epub 2011 Mar 17.
Clinical trial NCT02097498: Improving Patient Safety Through Simulation Research
Official title: Improving Patient Safety Through Simulation Research: Airway Management Proficiency Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Management Assessment
Keywords: Simulation
Enhance
Safety
Proficiency
Paramedics.
Airway Management
Intubation
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2014-03-27
Enrollment: 387
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overall objective of the present proposal is to assess whether medical simulation can enhance the safety and proficiency profile of paramedics performing prehospital endotracheal intubation, and whether feedback from an airway management expert observing the simulation enhances skill retention after 12 and 24 months. Since no validated proficiency assessment tool currently exists to measure the skill of paramedics in airway management, one will be developed and tested. Using this tool, 250 paramedics in central Ohio, will undergo simulation training similar to that required for certification. A baseline assessment of proficiency will be obtained. One group will be randomized to receive simulation training similar to that required for certification, while the other group will receive feedback from an airway management expert linked to the simulation test site via a 2-way audio-video feed. Both groups of paramedics will be reassessed at 12, and 24 months to determine whether skill level was maintained or whether skills deteriorated, and whether expert intervention had any impact on skill retention.


Eligibility criteria: Inclusion Criteria:

* Currently certified central Ohio paramedics

Exclusion Criteria:

* Refusal to participate
* Non-certified paramedics

Primary outcomes:
measure: Development and validation of an airway management assessment tool
timeFrame: 3 years
Secondary outcomes:
measure: Development of educational interventions to improve skill retention
timeFrame: 2 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Thomas E Terndrup, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05417698: Evaluation of Lifestyle Modification on Cardiovascular Risk
Official title: Evaluation of Lifestyle Modification on Cardiovascular Risk in Overweight and Obese Postmenopausal Women: a Ghrelin-mediated Response
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Menopause
Cardiovascular Diseases
Obesity
Type2diabetes
Keywords: Ghrelin
Postmenopause
Lead sponsor: Swansea University
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised-controlled
Primary purpose: PREVENTION

Brief summary: This study proposes to examine the independent and combined effects of an 8-week home-based, equipment-free HIIT exercise intervention with/without Mediterranean diet through ghrelin-mediated alteration in overweight and obese metabolic women to improve cardiovascular-risk related markers and metabolic risk factors.

Detailed description: This is a randomised-controlled study investigating the independent and combined effects of a home-based, equipment-free high intensity interval training (HIIT) exercise intervention with/without the Mediterranean diet (MedDiet) through ghrelin-mediated alteration on body composition, cardiovascular risk-related markers, metabolic markers and obesity-related hormones in postmenopausal women. The intervention will last for 8-weeks, with three arms comprising of 1) exercise only (Ex); 2) exercise and MedDiet (Ex+MedDiet); 3) control (no intervention).

Eligibility criteria: Inclusion Criteria:

* Female
* Participants \>45-65 years of age
* Body mass index (BMI) \>25.0 - 35.0
* Postmenopausal (with spontaneous amenorrhea for the last 12 months)
* Healthy (no known diseases)
* Physically inactive (IPAQ score - category I and not engaged in at least 60 min/week of structured exercise during the previous 6 months)
* Generally well enough to exercise.

Exclusion Criteria:

* Any inclusion criteria not met
* Abnormal ECG
* Current smokers
* Current or history of substance abuse and/or excess alcohol intake
* Cardiovascular disease
* Cancer
* Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
* Kidney disease
* Liver disease
* Pancreatitis
* On hormone therapy for \<6 months
* Prescribed anti-hypertensive or beta-blocker medication

Primary outcomes:
measure: Visceral adiposity index (VAI)
timeFrame: Baseline to 8 weeks
measure: Inflammatory markers
timeFrame: Baseline to 8 weeks
measure: Blood lipid levels
timeFrame: Baseline to 8 weeks
measure: Blood pressure
timeFrame: Baseline to 8 weeks
measure: Insulin resistance index (HOMA-IR)
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Circulatory levels of ghrelin
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
city: Swansea
country: United Kingdom
facility: Swansea University
Study officials:
References:
Clinical trial NCT03618498: Internal Limiting Membrane Flaps for Coexistent Macular Hole and Retinal Detachment
Official title: Internal Limiting Membrane Flaps for Coexistent Macular Hole and Retinal Detachment in Eyes of Proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Detachment
Keywords: macular hole
retinal detachment
PDR
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: A 25-gauged blunt-tipped needle connected with Viscoat® (Alcon laboratories, Fort Worth, TX, USA) containing syringe was placed within the macular hole just below the level of the macular hole. A small amount of Viscoat® was injected into and around the hole. An ICG solution (25 mg ICG in 15 ml 5% glucose-water solution, final concentration = 1.7 mg/ml) was then carefully applied around the macular hole within the arcade.Excessive ICG was immediately removed by suction. ILM at the parafoveal area was peeled in a circular fashion. Care was taken not to peel the ILM flap across the hole edge. If possible, at least 1.5 to 2 disc area of partially detached ILM around the hole was left in place with central part remained attached to the edge of the hole.
Primary purpose: TREATMENT

Brief summary: Purpose: To evaluate the logical surgical approaches in closing macular holes in eyes of proliferative diabetic retinopathy with retinal detachment

Detailed description: High MH closure rate can be achieved. Other than high myopia, MH with RD may appear in several conditions, such as severe vitreomacular traction, proliferative diabetic retinopathy (PDR).clinical charts were reviewed of patients of proliferative diabetic retinopathy suffering from MH with RD who were treated with vitrectomy combined with inverted epiretinal ILM flap,inverted ILM flaps insertion techniques, or free ILM flaps.Standard 3-port 23 or 25 gauged pars plana vitrectomy was performed. After core vitrectomy, anterior-posterior oriented tractions as well as all fibrovascular tissues were removed as thoroughly as possible.The patients were kept in a facedown position overnight and were allowed to take any positions except supine for approximately one week.Various surgical approaches utilizing in managing macular hole may effectively closing macular holes and reattach retina.

Eligibility criteria: Inclusion Criteria:

* Patients were proliferative diabetic retinopathy suffering from MH with RD.

Exclusion Criteria:

* Patients were not proliferative diabetic retinopathy suffering from MH with RD.

Primary outcomes:
measure: Wilcoxon Sign-Rank test
timeFrame: Baseline, 12 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
Study officials:
affiliation: Changhua Christian Hospital
name: Chen San-Ni, MD
role: STUDY_DIRECTOR
References: