cyrilzakka/clinical-trials huggingface dataset:
Usability Study of "ArmAssist 2.0." Robot: Homecare Arm Rehabilitation in Stroke Patients

The purpose of this study is to validate the usability of ArmAssist medical device, a robotic system for the rehabilitation of upper limbs in stroke patients (based on serious games). This study evaluate the usability of the system in a home environment, taking into account the ease-to-use, consistency and others; and will pretend demonstrate the feasibility of including or no, robotic therapy in home like complement of daily rehabilitation program. Finally this study investigate the acceptance from patients and therapists.


Eligibility Criteria:
Inclusion Criteria:

* Subjects over 18,
* Upper limb hemiparesis after stroke,
* Unilateral paresis and cognitive ability to understand,
* Accept and actively participate in the usability study.

Exclusion Criteria:

* Bilateral motor deficit,
* Severe spasticity,
* Psychiatric illness,
* and/or cognitive impairment.
Study to Evaluate the Reliability, Validity and Safety of Subjective Mobile Refraction

This study evaluates the reliability, validity and safety of a self administered, subjective refraction test via a mobile medical app (GoEyes) as compared to standard of care subjective manifest refraction performed by a health care provider, in subjects who have no known ocular disease or condition other than refractive error.

GoEyes is a Mobile Medical Application, which can be downloaded to a smartphone and is being developed as a self -administered subjective refraction examination that measures the refractive error of the user's eyes in the home environment without any contact or help from health care professionals.

The Study will be conducted in 2 parts; Part 1 and Part 2.

Approximately 59 participants will be enrolled In Part 1. Part 1 participants will have a GoEyes refraction test in clinic on two separate days and will also have a standard of care refraction test performed by a health care provider and best corrected visual acuity assessments.

Approximately 349 participants will be enrolled in Part 2. Part 2 participants will self administer the GoEyes test at home on 2 separate days and will also have in clinic standard of care refraction test performed by a health care provider and best corrected visual acuity assessments.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged 18-39 years who currently wear glasses and/or soft contact lenses to correct refractive error
2. Normal color vision
3. Able to use both hands at the same time and to hear, understand and verbally respond to audio instructions
4. Have single vision lenses only
5. Able to provide informed consent -

Exclusion Criteria:

1. Have any ongoing disease or ocular condition other than refractive error
2. Have a history of permanent vison loss
3. Have a neurological condition affecting vision
4. Have worn glasses since age 6 or younger
5. Have a prism in their prescription
6. Use Rigid gas permeable lenses or OrthoK lenses
7. Have had laser refractive surgery or any other eye surgery
8. Use prescription eye drops -
Neuropsychological Outcome After Cardiac Arrest

This study is a sub-study to the large pragmatic Target Temperature Management 2 Trial (TTM2-trial, ClinicalTrials.gov Identifier: NCT02908308), assessing effectiveness of controlled hypothermia after out-of-hospital cardiac arrest (OHCA).

This study is designed to provide detailed information on cognition after OHCA and its relationship to associated factors as emotional function, fatigue, and sleep. A secondary aim is to utilize this information to validate a neurocognitive screening battery used 6 months after OHCA in the TTM2-trial.

Approximately 7 and 24 months after OHCA, survivors at selected TTM2 study sites will perform a standardized neuropsychological assessment including performance-based tests of cognition and questionnaires of behavioral and emotional function, fatigue, and insomnia. At 1:1 ratio, a control group of myocardial infarction (MI) patients but no occurrence of cardiac arrest will be recruited and perform the same test battery. Group differences at 7 and 24 months will be analyzed per cognitive domain (verbal, visual/constructive, short-term working memory, episodic memory, processing speed, executive functions). Results of the OHCA survivors on the TTM2 neurocognitive screening battery will be compared with neuropsychological test results at 7 months time.


Eligibility Criteria:
Inclusion Criteria:

* OHCA of a presumed cardiac or unknown cause (OHCA cohort only)
* Sustained return of spontaneous circulation (ROSC) during intensive care - defined as 20 minutes with signs of circulation without the need for chest compressions (OHCA cohort only)
* Unconsciousness - defined as not being able to obey verbal commands (FOUR-score motor response of \<4) and no verbal response to pain after sustained ROSC (OHCA cohort only)
* Inclusion within 180 minutes of ROSC (OHCA cohort only)
* During intensive care - eligible for intensive care without restrictions or limitations (OHCA cohort only)
* MI with performed coronary angiography (MI cohort only)

Exclusion Criteria:

* Temperature on admission \<30°C (OHCA cohort only)
* On extracorporeal membrane oxygenation (ECMO) prior to return of spontaneous circulation (OHCA cohort only)
* Obvious or suspected pregnancy
* Intracranial bleeding (OHCA cohort only)
* Severe chronic obstructive pulmonary disorder (COPD) with long-term home oxygen therapy
* Clinical dementia diagnosis before the event
* Inability to speak the local language well enough to complete the assessment without assistance from an interpreter
* Inability to meet for a face-to-face examination
* Clinical Frailty Scale Index ≥8, indicating very severe frailty
* Cardiac arrest before or in connection with MI (MI cohort only)
* Active substance abuse
Lymph Node Involvement Using Extended Pelvic Lymphadenectomy in Clinically Localized Prostate Cancer

Prostate cancer is considered the fourth most common malignancy cancer in America. However, in Colombia the incidence is higher, and it is considered the second cause of death among men for malignance diseases. In the framework of clinical localized prostate cancer there is a controversy regarding the best predictors of risk and the best treatment options. The actual literature is discussing the possibility of underestimate the disease and actual tools are not sufficient for proper characterization. Is in this context that extended pelvic lymphadenectomy emerges as a stratification tool in prostate cancer that defines the real commitment of the disease. The investigators need to know the characteristics that the disease has on the investigators community so the investigators can generate appropriate therapeutic approach. Thus, the present prospective observational-descriptive multicenter study, want to determine in three referral centers in Bogotá Colombia , the frequency of pelvic node involvement in patients with localized clinical prostate cancer from the stratification achieved by pelvic lymphadenectomy extended.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical localized prostate cancer
* Clinical stage: cT1-cT2-, N0-Nx, M0-Mx
* Patients who undergo radical prostatectomy and extended lymphadenectomy in one of the 3 centers of reference.

Exclusion Criteria:

* Patients in which the standard technique of the extended lymphadenectomy could not be done and it was changed.
Combined Optical and Infrared Imaging for Early Prediction of Erythema During Breast and Chestwall Radiotherapy

The aim of this study is to develop a computer model, based on photographs and heat images of patients' skin, to provide early prediction of painful reddening of the skin during radiotherapy treatment.

There is currently no reliable tool to quantify and detect erythema of the skin during radiotherapy. This side-effect may lead to painful moist desquamation, and eventually permanent delayed side effects like telangiectasia. If such a tool would be available, several interventions could be staged, including (1) the use of steroid cream\], (2) the re-simulation and/or re-planning of patients to decrease the skin dose by spreading out the entrance of the beams, (3) adjusting or eliminating the use of bolus on the skin surface (which boosts superficial dose) or (4) the use of other treatment techniques including prone technique.

Given that the dose delivered is not a reliable metric to predict for erythema in a given patient, a new method for monitoring, staging and ultimately predicting skin response is needed. By analyzing images of the skin using both visible and infrared spectral regions, and by carefully converting the information in the images to quantitative metrics, it may be possible to characterize the stage of a patient's response to radiation, and to understand which patients may go on to experience chronic pain, severe burns or other more serious side effects while it is still early enough to intervene.

The proposed research is to develop a software model that will take as input patient skin image data and the patient known clinical outcomes and algorithmically generalize a model to predict a biological response of skin to ionizing radiation for any future patient, after a few initial images.

In the first stage of this study, the data will be aggregated to devise the dose response curve. In later phases, the model will be refined and used for predictive purposes, i.e., once a new patient has begun radiotherapy sessions, their initial response will be quantified, and fed into the model to predict the skin response endpoint after the course of radiation therapy ends. As mentioned, this information could be used to adapt the radiation course and optimize the therapy for the individual, potentially preventing morbidity from overdose, or risk of recurrence from under dose.

Eligibility Criteria:
Inclusion Criteria:

- All female patients referred for adjuvant radiotherapy following breast conserving surgery/mastectomy.

Exclusion Criteria:

* Patients with known skin issues (e.g. dermatomyositis, rosacea)
* Patients with excessive risk of skin recurrence, including T4d
* Patients with locally advanced breast cancer.
Blood Flow Restriction Training in Multiple Sclerosis

Traditional physical therapy resisted training for people with MS have been shown to be beneﬁcial; however, their usefulness has been limited by fatigue. The effect of blood flow restriction on strength and other measures of physical function was demonstrated in healthy populations and those with chronic disease. This study may add missing information to the existing literature and suggests directions for research on the effectiveness of BFR training on individuals with relapsing and remitting MS.

Multiple sclerosis patients are characterized by impaired functional capacity which is related to reduce muscle strength affecting predominantly the lower extremity.

Resistance training (RT) has proven to be one of the interventions in MS patients showing a consistent and positive effect on muscle strength and on parameters directly related to lower extremity physical function (eg, walking performance and stair negotiation).

Training with blood flow restriction (BFR), is an increasingly common clinical intervention among physical therapists over the past decade and consistent with the evidence. It has been investigated in people with neurological disorders including stroke and incomplete Spinal Cord Injuries. Research is limited on the use of BFR for individuals with MS.

Eligibility Criteria:
Inclusion Criteria:

1. Patients were diagnosed with MS by a neurologist according to McDonald's criteria 2010
2. Expanded Disability Status Scale (EDSS) scores ranging from 2.5 to 5.5 .
3. Patient able to walk 100 meters or more.
4. No change within MS specific medication three months from the study.
5. Last Ms Attack from more than two months.

Exclusion Criteria:

1. Multiple sclerosis patients with other neurological or orthopedic problems.
2. Multiple sclerosis patients with systemic problems (cardiovascular or pulmonary diseases...).
3. Patients with cognitive impairment.
4. Pregnant female patients.
5. Patients in acute relapse stage.

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Efficacy of Two Enzyme Cocktails in Healthy Adults

The goal of this study is to determine the safety and efficacy of two enzyme cocktails in healthy adults with mild to moderate gastrointestinal discomfort. The main question aims to answer whether a 4-week administration of an enzyme cocktail can improve how the participant feels about their gut health. This is done by completing a weekly questionnaire, and the results are compared between the 4 weeks the participants are on a placebo and the 4 weeks the participants are on the enzyme cocktail. Participants will also provide a stool sample at the start and end of each treatment. Stool samples will collected and stored in case further microbiome analysis is warranted.


Eligibility Criteria:
Exclusion Criteria:

* Presence of a serious congenital anomaly or chronic medical condition that would contraindicate participation, including history of major gastrointestinal surgery, chronic gastrointestinal illness, abnormal intestinal anatomy or significant abdominal disorder
* Having taken oral antibiotics in the previous 3-months or if they start antibiotics during the study
* Currently or having taken a prebiotic, probiotic, or digestive enzyme supplement in the previous 3-months
* Currently consuming 1 or more servings of fermented foods or yogurt on a daily basis
* Doctor diagnosed chronic disease (i.e. Diabetes, Cardiovascular, etc.)
* Doctor diagnosed immunodeficiency
* Current use of doctor prescribed immunosuppressive agents (corticosteroids, methotrexate, etc.)
* Pregnancy, 6 months postpartum period, or current breastfeeding
* Women of childbearing age planning pregnancy during the course of the study
RSA Study on the Behaviour of the Growth Plate During and After Temporary Hemi-epiphysiodesis and Epiphysiodesis

By using radiostereometric analysis (RSA) we will be able to study growth during and after temporary epiphysiodesis and with great accuracy be able to detect asymmetric growth following this procedure.

By using the same method we also want to analyse patients with axial deviations operated with guided growth (tension band plating) to study the growth during and after the procedure and be able to set the correct timing for removal of the implant.

The RSA method consists of implantation of small tantalum beads on either side of the physis during surgery on the the physis. Later analysis of the RSA Pictures with the RSA-method will give us an microscopically accurate measure of the growth in three planes.

Eligibility Criteria:
Inclusion Criteria:

* Children with idiopathic axial deviations in the lower extremities
* Children with limb length discrepancys where timing of epiphysiodesis is difficult because of a big discrepancy in skeletal age and chronological age

Exclusion Criteria:

* Children with axial deviations and pathological physis
Effect of Using Barrier Devices for Intubation in COVID-19 Patients

The aim of this study is to compare the impact of using the aerosol box and transparent sheet as an adjunct to conventional personal protective equipment on endotracheal intubation of COVID-19 patients. The effect of the head of the bed elevation will also be evaluated during the mentioned simulated scenarios.

This is a randomized, prospective, manikin simulation study. Emergency medicine specialists will be participated in the study. Participants will be randomly assigned into 6 groups with a 1:1:1:1:1:1 allocation following simple randomization procedures by a program generating online random numbers. 13 participants will be recruited to the study.

Operators who will intubate the manikin will use following methods: (1) conventional personal protective equipment (PPE) with placing the manikin in the supine position. (2) aerosol box as an adjunct to PPE with placing the manikin in the supine position. (3) transparent sheet as an adjunct to PPE with placing the manikin in the supine position. (4) conventional personal protective equipment (PPE) with placing the manikin in the 30 degree the head of the bed elevated position. (5) aerosol box as an adjunct to PPE with placing the manikin in the 30 degree the head of the bed elevated position. (6) transparent sheet as an adjunct to PPE with placing the manikin in the 30 degree the head of the bed elevated position.

Eligibility Criteria:
Inclusion Criteria:

* Participants who want to participate the study

Exclusion Criteria:

* Participants who do not want to participate the study
Evaluation of Conventional Antibiotic Prophylaxis During a Change of Hip or Knee Infected at a Time

Infection is a serious complications after undergoing total hip replacement. It occurs in about 1% of cases. The optimal treatment of these infections is discussed. The team validated by international publications change strategy of the infected prosthesis at a time.

Antibiotic prophylaxis has significantly reduced the infection intraoperative contamination in orthopedic surgery rates. It must be conventionally administered before the surgical incision. In response to infection, it is typically recommended to start this antibiotic after the completion of the deep bacteriological samples, so as not to negate the risk of these samples by the prior administration of antibiotics. This attitude, however, is not formally validated by the scientific literature. In contrast, two recent publications challenge this practice, and suggest the use of a conventional antibiotic prophylaxis even in septic interventions. Our multidisciplinary team opted for a few months for this new strategy. We wish to evaluate the influence of this new approach results in the treatment of infection in total hip or knee.


Eligibility Criteria:
Inclusion Criteria:

* patients operated in service between January 2012 and July 2013 for treatment of an infection of total hip or knee.

Exclusion Criteria:

* patients operated in service before January 2012 and after July 2013 for treatment of an infection of total hip or knee.
Using Yoga to Reduce Chaos and Improve Preschooler Sleep

The goal of this intervention study is to learn if a yoga-based bedtime routine is feasible for families to follow and to learn if the routine is effective at improving preschooler sleep. The main question it aims to answer is:

Will families be able to follow the routine regularly during the study period? Will following the yoga routine improve household chaos and preschooler sleep? Researchers will compare the yoga group to a control group to see if implementing the yoga routine works better than simple advice to read a bedtime story.

Participants will be asked to visit the lab 4 times. At the first visit, we will measure body size of parents and children, ask parents to complete some surveys, and fit each of them with an activity monitor. One week later, they will return for the second visit. At this visit, we will collect the activity monitor and assign the participants to either the intervention (yoga) or control (bedtime story) group. Families in the intervention group will learn about the intervention and be asked to follow it for the next four weeks. Families in the control group will receive a book and advice about reading stories at bedtime. After four weeks, families will return to the lab for a third visit and we will repeat the measurements from visit 1. Then, families in the intervention group will be asked to follow the yoga routine as much as they would like to for the next 4 weeks. Families in the control group will \&#34;cross over\&#34; to the intervention group and will follow the yoga intervention for 4 weeks. Then, families will return to the lab for a 4th visit, where we will repeat all of the measures from the first visit and the study will be complete.


Eligibility Criteria:
Inclusion Criteria:

* Children between 2.0-5.9 years of age and their self-identified primary parent/guardian

Exclusion Criteria:

- Parent currently pregnant Child or parent unable to walk independently Child or parent has an upper body mobility limitation that precludes completion of yoga routine
Evaluating Impact and Implementation of Choose to Move (Phase 3)

The objectives of this study are to 1) evaluate whether Choose to Move (CTM) improves health outcomes in older adults who participate and 2) assess whether CTM is delivered as planned and what factors support or inhibit delivery at scale.

CTM is a 6 month, choice-based program for low active older adults being scaled-up across British Columbia, Canada. The goals of CTM are to enhance physical activity, mobility and social connectedness in older adults living in British Columbia, Canada.

CTM is a 6 month, choice-based program for low active older adults being scaled-up in phases across British Columbia, Canada. Within CTM (phase 3), trained activity coaches support older adults in three ways. First, in a one-on-one consultation, activity coaches help participants to set goals and create action plans for physical activity tailored to each person's interests and abilities. Older adults can choose to participate in individual or group-based activities. Second, activity coaches facilitate a series of group meetings with small groups of participants. Finally, activity coaches regularly check in with participants to provide ongoing support. Activity coaches and recreation departments across BC are trained and provided with resources to deliver CTM.

Objectives:

1. To assess the impact (effectiveness) of CTM (phase 3) delivered at scale on the physical activity, mobility and social connectedness of older adults (Part I - Impact Evaluation)
2. To assess whether the program was implemented as planned (fidelity) and investigate factors that support or inhibit implementation at scale (Part II - Implementation Evaluation).

Study Design:

We use a hybrid type 2 effectiveness-implementation (Curran et al 2012) pre-post study design to evaluate CTM. We use mixed-methods (quantitative and qualitative) and collect data at 0 (baseline), 3 (mid-intervention), 6 (post-intervention) and 18 (12-months post-intervention) months to assess effectiveness and implementation of CTM.

Eligibility Criteria:
Inclusion Criteria (older adults):

* ≥60 years of age,
* demonstrate readiness for physical activity via the PAR-Q+ questionnaire (Warburton et al 2011), Get Active Questionnaire (Canadian Society for Exercise Physiology 2017) or a letter of recommendation from their physician
* \<150 min/week physical activity
* English speaking

Exclusion Criteria (older adults):

- previous participation in CTM

Inclusion Criteria (delivery partners):

* Activity coaches will be English speaking BCRPA Registered Older Adult Fitness Leaders or Kinesiologists who are delivering CTM at participating centres
* Recreation Managers and Coordinators affiliated with participating centres delivering CTM
* Provincial Partners (e.g., individuals/partners who make strategic and/or policy decisions) at partner organizations delivering Choose to Move
A Study to Evaluate the Effect of 2 Drugs on the Pharmacokinetics of BMS-986205 in Healthy Subjects

Assess the effects of itraconazole and rifampin on the pharmacokinetics, safety, and tolerability of BMS-986205.

A randomized, open-label, parallel design study in healthy participants to assess the effects of itraconazole and rifampin on the single-dose pharmacokinetics of BMS-986205. Safety and tolerability data to be collected and assessed as well.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index 18.0 to 32.0 kg/m2, inclusive
* Must have normal renal function demonstrated by GFR, calculated by Chronic Kidney Disease Epidemiology Collaboration formula
* Women must not be of childbearing potential (cannot become pregnant)

Exclusion Criteria:

* Any significant acute or chronic medical illness
* History of glucose-6-phosphodiesterase (G6PD) deficiency
* Personal or family history of cytochrome b5 reductase deficiency

Other protocol defined inclusion / exclusion criteria could apply