cyrilzakka/clinical-trials huggingface dataset:
Design and Validation of a Mobile Health Application for Home-Based Musculoskeletal Therapy in Ankle Sprain

"Ankle sprain is a common musculoskeletal injury that can pointedly influence the quality of life of an indivual. Old rehabilitation approaches often require recurrent clinic visits, which can be time-consuming, costly, and unreachable to many. This study aims to design and validate a mobile health application for home-based musculoskeletal therapy in ankle sprain.

The study will employ a randomized controlled trial design, involving patients with ankle sprains, healthcare professionals, and healthy volunteers. The mobile health application will be designed to provide personalized exercises, education, and monitoring to improve rehabilitation outcomes. The study will evaluate the effects of the mobile health application (m Health) in reducing pain, improving functional ability, and ornamental quality of life. The study will also assess the usability and acceptability of the application among patients and healthcare professionals.

Outcome measurement tools will contain the Foot and Ankle Ability Measure (FAAM), Numeric Pain Rating Scale (NPRS) and System Usability Scale (SUS) The study will contribute to the development of an innovative, home-based rehabilitation solution for individuals with ankle sprains, improving accessibility and adherence to rehabilitation programs.

Eligibility Criteria:
Inclusion Criteria:

* Adults, 18-65 years, both gender(male and female) will be included.
* Include participants clinically diagnosed with a lateral ankle sprain confirmed by a healthcare professional, with a clear timeframe such as within the last 4-6 weeks.
* Grade I and II sprains (mild to moderate) will be included using NPRS tool range from 0 to 6.
* Participants must own and be able to use a smartphone or tablet that is compatible with the mobile health application.
* Specify that participants must be able to read and understand the application interface language.
* Ensure participants can safely perform the exercises prescribed in the app without additional risk of injury

Exclusion Criteria:

* Concurrent fractures of the leg or foot.
* Previous surgery in the affected ankle or surgery resulting from the current ankle sprain.
* Serious systemic illnesses (e.g. rheumatoid arthritis, or fibromyalgia).
* Neurological impairments or other conditions that may affect rehabilitation outcomes
Post-marketing Clinical Study of the LAMBRE System for Left Auricle Closure

Atrial fibrillation (AF) is responsible for 15-20% of ischaemic strokes. These events are often caused by thrombus formation in the left atrium. Thromboembolic risk in AF is primarily prevented by oral anticoagulation. However, this drug-based approach has a number of limitations, the most important of which are compliance problems and, above all, the risk of haemorrhagic complications, some of which are potentially serious. Left atrial appendage closure is a therapeutic alternative for the prevention of cardioembolic risk in cases where anticoagulation is clearly contraindicated.

The CNEDiMTS opinion of 12 March 2019 defines that the LAMBRE, LIFETCH prosthesis, a device for transcatheter closure of the left atrial appendage, is authorised for the prevention of thromboembolic events in patients with non-valvular atrial fibrillation at high risk of thromboembolic events with a CHA2DS2-VASc score ≥ 4 and a formal and permanent contraindication to anticoagulants (validated by a multidisciplinary committee).

LAMBRE prosthesis in France are subject to a review of the results by the CNEDIMTS committee. Among the criteria analysed regarding the efficacy and safety of the device implantation, the result regarding the migration rate of the LAMBRE device will be one of the criteria enabling the Commission to decide on the appropriateness of the renewal of the registration.


Eligibility Criteria:
Inclusion Criteria:

* Patient requiring a left atrial exclusion procedure according to the recommendations by the CNEDiMTS and HAS using the LAMBRE device
* Age ≥18 years
* Patient has been informed of the nature of the study and agrees to participate

Exclusion Criteria:

* Minor patient
* Patient refusing to participate in the study or unable to give informed consent (patient under guardianship, curatorship or safeguard of justice)
Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System

This is a clinical study of a new self-expanding stent (FlexStent®) designed specifically to cope with the extreme demands of the superficial femoral artery (SFA)/proximal popliteal artery. The arteries are often abbreviated as femoropopliteal.

The intent of this study is to demonstrate that the FlexStent® Femoropopliteal Self-Expanding Stent System is safe and effective for the treatment of patients with peripheral arterial disease. Specifically, the FlexStent® shall meet or exceed the proposed safety and efficacy performance goals established for Femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease.


Eligibility Criteria:
Inclusion Criteria:

All subjects must meet the following criteria:

1. Subjects, male or female, must be at least 35 years of age at the time of consent. A female of childbearing potential may be enrolled, provided she has a negative pregnancy test within 7 days of screening.
2. Subjects must give written informed consent prior to participation in the study and must understand the purpose of this study and be willing to adhere to the study procedures described in this protocol.
3. Rutherford Classification Category 2-4
4. De novo lesion in the Femoropopliteal artery, including the entire extent of the superficial femoral artery and the proximal portion of the popliteal artery extending to the medial condyle 3 cm above the knee joint
5. Disease segment length ≤ 180 mm
6. \>70% diameter stenosis and/or occlusion based on site-determined visual angiography
7. Patent ipsilateral iliac artery
8. Patency of ipsilateral mid/distal popliteal artery and at least 1 tibial artery with no planned intervention
9. Target reference vessel diameter 3.5-7.5 mm.
10. Projected life expectancy of 12 months or greater
11. Patient is available for follow-up for 36 months and is willing and able to comply with all follow-up requirements
12. Patient is willing and able to provide signed informed consent

Exclusion Criteria:

Any subject meeting any of the following criteria will be excluded from the study.

1. Target vessel previously treated with a stent
2. Target lesion within 1.5 cm of the ostium of the SFA
3. Rutherford Classification Category 0,1,5 or 6
4. Inability to tolerate antithrombotic or antiplatelet therapies
5. Pregnancy (female of child-bearing age confirmed pregnant)
6. Other comorbidity risks which in the opinion of the investigator limit longevity or likelihood of complying with protocol follow up.
7. Serum creatinine \> 2.5 mg/dL
8. Myocardial infarction or stroke within 30 days of treatment date
9. Known hypercoagulable state
10. Known bleeding diathesis
11. Untreated angiographically-evident thrombus in target vessel
12. Patients currently enrolled in any other clinical trial
COMPASS: a Comprehensive Mobile Precision Approach for Scalable Solutions in Mental Health Treatment

This research study is being conducted to understand if patients benefit from mobile health interventions while waiting for in-clinic mental health treatments.


Eligibility Criteria:
Inclusion Criteria:

* Seeking mental health services from Michigan Medicine, University Health Services, or collaborative clinics and services.
* Must have daily access to a smartphone version that is compatible with study activity trackers.
* Understands English to enable consent and use of the MyDataHelps app and app-based interventions

Exclusion Criteria:

* Self-reported or medical record indication of a current eating disorder
* Unable to provide informed consent (e.g., cognitive or guardianship restrictions)
* Scheduled outpatient mental health appointment is a pediatric appointment (even if age 18+)
Comprehensive Nano - Post Market Clinical Follow-Up Study

This data collection project is intended to provide clinical outcomes data to engineering, marketing as well as fulfill the post market surveillance requirements of various regulatory authorities. The study will be a prospective and one-arm.

The Comprehensive® Shoulder System with Nano humeral component is a humeral prosthesis system intended for use in total or hemi shoulder arthroplasty surgery. Total shoulder arthroplasty consists of replacement of the humeral head and glenoid. Hemi-arthroplasty consists of replacement of only the humeral head.

This project is a prospective study including one-hundred and fifty (150) anatomic and hemi cases and 44 reverse shoulders collected from up to ten (10) sites. All potential study subjects will be required to participate in the Informed Consent process.

Eligibility Criteria:
Inclusion Criteria:

* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
* Rheumatoid arthritis
* Revision where other devices or treatments have failed
* Correction of functional deformity.
* Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate
* Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate

Exclusion Criteria:

* Infection
* Sepsis
* osteomyelitis
EmbracePlus, Care App and Aura Usability Study

The purpose of this study is to evaluate the usability of the system which includes the wearable device, app and cloud data processing, including an algorithm (Aura) capable of detecting possible early signs of respiratory infections in healthy individuals.

In addition, the investigators would like to evaluate the presence of any allergic reactions to materials used in the manufacture of the EmbracePlus.

The investigators wish to evaluate of the usability, according to the requirements of IEC 62366-1:2015/AMD 1:2020 of a wearable device - EmbracePlus, the Empatica Care app and Aura algorithm, an early-warning wearable/AI platform for alerting to COVID-19 and other possible respiratory infections before a person is symptomatic. The system consists is a smartwatch coupled with an AI algorithm (Aura) developed by Empatica. The Aura algorithm analyzes physiological signals and derived biomarkers (such as sleep patterns) in order to detect possible early signs of respiratory infection. It has been originally developed by Empatica, validated with influenza and rhinovirus data and is being currently validated for COVID-19 infections.

Eligibility Criteria:
Inclusion Criteria:

1. Age: Participants must be between the ages of 18-99
2. Gender: No restrictions
3. Disease: healthy participants
4. Adult participant must either be able to give consent
5. Participants must be fluent in the language of the consent forms (Currently limited to English).
6. Participants must reside in the United States.
7. Participants should have a physical home address where they can receive the device
8. Participants must have a personal smartphone Apple or Android (at least iPhone 8 or Android 5.0)

Exclusion Criteria:

1. Participants must not have broken or injured skin at the wrist where EmbracePlus is worn, and they must be able to tolerate wearing EmbracePlus snugly for long periods of time. Thus, they should not have allergies to the material composition of the EmbracePlus smartwatch, or discomfort wearing a smartwatch during the night.
2. Participants are not willing to wear the device during nighttime
3. Participants should not have pre-existing cardiovascular disease or respiratory disease
4. Participants must not be pregnant or planning to become pregnant within two months at the time of screening
Digital Gait Analysis in the Home Environment of Patients With Multiple Sclerosis

The aim of this study is the development of novel telemedical examination methods based on sensor-based gait analysis in patients with multiple sclerosis (MS). In a first step, the basic technical feasibility of measuring gait parameters in MS patients under standardized conditions in the clinic and in the home environment of the study participants will be investigated.

In a subsequent two-week study phase, gait parameters (real-life monitoring) and standardized gait tests will be continuously recorded in the home environment of the study participants. The comparability of the collected gait parameters from standardized gait tests and real-life monitoring to clinical scales (e.g. EDSS) will investigate the medical applicability of gait analysis as a target parameter in MS patients.

New algorithms for detecting indication-specific gait patterns from gait analysis in patients' daily lives and their possible changes over time (progression) will be explored and implemented into the study system. In addition, a patient app annotates the standardized gait tests and collects questionnaire-based data from the study participants during real-life monitoring. Via a study tablet, the data of the gait analysis and the patient app are transmitted to a study platform (Digital Patient Manager). The clinical assessment data (neurological examination, questionnaires) can be entered via a web front-end of the study platform and assigned to the patient via a pseudonym.

A further aim of this study is to validate the technology used for its applicability in the home environment. By means of structured interviews after the study phase, the study participants will be asked about compliance and adherence.

The following scientific questions will be investigated in this project:

(a) Is gait analysis a feasible and meaningful target parameter for MS centers? b) Are gait parameters from real-life monitoring suitable biomarkers for the detection of MS symptoms? c) Can gait parameters from standardized gait tests be compared with different testing environments (clinic / home environment)? d) How do gait parameters from standardized gait tests differ from gait data from real-life monitoring? e) How is the telemedical application for the collection of gait parameters evaluated by the patients? f) Can disease progression be detected using sensor-based gait parameters from the home environment?


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple sclerosis according to McDonald criteria
* Expanded Disability Status Scale (EDSS) 1-6
* Age \> 18 years
* Ability to speak and read
* Ability to use an application running on a smart device
* Patient informed consent

Exclusion Criteria:

* Severe difficulty walking with frequent falls
* Inability to walk at least 10 meters
* Permanent use of a wheelchair
* Severe spasticity
* Cognitive impairment with inability to give consent to protocol
Use of Virtual Reality Games for the Treatment of Balance and Reducing the Occurrence of Falls in Patients After Stroke

The aim of this study was to investigate the therapeutic effect of virtual reality associated with conventional physiotherapy on balance during gait and the occurrence of falls in patients after stroke.

Randomized clinical trial conducted with patients of both sexes with hemiparesis after stroke of 18 to 65 years. They excluded those who had less than six months of injury, with sensory or perceptual deficit. Patients included were randomized into two groups, a treatment group, which conducted rehabilitation with virtual reality associated with conventional physical therapy and the control group that performed only conventional physiotherapy. Randomization was done by a computer program in blocks, by a third person, respecting the allocation concealment. After selection and randomization, patients were evaluated at baseline, when they were collected demographic and clinical data, investigated the occurrence of falls in the three months prior to evaluation and rated the balance in motion using the Dynamic Gait Index (DGI). Patients were followed for 20 physiotherapy sessions, visits twice a week for an hour each. The assessment of the balance and the investigation of the occurrence of falls were repeated at the end of treatment, which occurred on average three months after the start of the intervention, by the same examiner, who remained blind to the group that the patient belonged.

Eligibility Criteria:
Inclusion Criteria:

* patients of both sexes with hemiparesis after stroke of 18 to 65 years.

Exclusion Criteria:

* less than 6 months of injury with sensory or perceptual deficit.
Second Malignant Neoplasms After Childhood ALL Therapy

Development of a second neoplasm (SMN) during or after therapy for childhood acute lymphoblastic leukemia (ALL) is a rare event generally associated with a poor prognosis. In this international study we analyze subtypes of SMN in relation to their initial leukemia characteristics and treatment, and their subsequent overall survival.

To explore epidemiology, potential risk factors and survival rates of second cancers occurring as the first event in childhood acute lymphoblastic leukemia the involved study groups will collect anonymous data on all such cases diagnosed within the last decades to form a common database with predefined variables comprising the clinical, biological, and cytogenetic characteristics (myeloid neoplasias only) as well as outcome. Furthermore, we will register the clinical, biological, and cytogenetic characteristics of the acute lymphoblastic leukemia as well as type of treatment given.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with childhood acute lymphoblastic leukemia
* Diagnosis of second cancer before December 31st 2007

Exclusion Criteria:

* Uncertainty if the second cancer has emerged from the same original leukemic clone
A Study to Evaluate the Effect of Venetoclax on Participants Receiving a Covalent Bruton's Tyrosine Kinase Inhibitor (cBTKi) for First-Line Chronic Lymphocytic Leukemia (1L CLL) to Achieve Deep Durable Remissions to Allow Off-Treatment Period.

The main purpose of the study is to evaluate if adding venetoclax to participants receiving cBTKi for the 1L CLL can achieve deep durable remissions of undetectable measurable residual disease \[uMRD \< or 10\^-4 in peripheral blood (PB)\] by end of combination treatment (EOCT) to allow off-treatment period.

The acronym BRAVE stands for Btki Responders to Achieve deep remission (or off-treatment periods) with VEnetoclax.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with CLL and currently receiving a stable dose of cBTKi (i.e., ibrutinib, acalabrutinib, or zanubrutinib) for at least 6 months for 1L treatment with a response of at least a PR per iwCLL criteria
2. Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (\</=) 2
3. Adequate renal and liver function

Exclusion Criteria:

1. Prior B-cell lymphoma (Bcl-2) inhibitor therapy
2. Progressive or stable disease on cBTKi
3. Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (Richter's transformation or pro-lymphocytic leukemia)
4. History of cardiomyopathy
5. Hypersensitivity to venetoclax or to any of the excipients (e.g., trehalose)
6. Clinically significant cardiovascular disease
7. Active bleeding or history of bleeding diathesis
8. Pregnant women and nursing mothers
9. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
An Examination of the Use of Electrophysiological Brain Monitoring to Direct the Treatment of Mild Cognitive Impairment

The problem of cognitive decline among the aging population has become a significant health burden, especially in light of the increase in the prevalence of dementia with age For patients with MCI (Mild cognitive impairment) there are various recommendations to deal with the disorder, including behavioral recommendations for physical exercise. Some recommendations could also be found for cognitive practice. However, currently, there is no consensus regarding effective cognitive treatment or practice for MCI. Among the populations suffering from MCI, there is a significant segment of patients with amnestic disorder. For these patients, it seems that cognitive training of memory, including verbal memory, is very important. In recent years, we have developed an effective tool for managing rehabilitation practice by monitoring the patient's engagement with an easy-to-use EEG (electroencephalogram) tool. We have shown in a variety of rehabilitation settings, that when the patient is recruited, the clinical improvement is significantly better. The aim of this study is to evaluate the ability to harness the EEG monitoring of brain engagement to achieve functional improvement in verbal memory training in patients with Amnestic MCI.


Eligibility Criteria:
Inclusion Criteria:

* Male or female above the age of 65 years
* Ability to read, write and understand the Hebrew language so to comply with study demands.
* Diagnosed with Amnestic MCI. Mini Mental State Examination (MMSE), A score of MSSE ≥27 for college educated subjects and MSSE ≥ 26 for all others; and (CDR) Clinical Dementia Rating, 0.5 ≥ CDR
* Diagnosed with memory impairment, Visual Paired Association = VPA (WMS-R), for subjects of ages 65-70, 16.5 ≥ WMS-R and for subjects of age above 71, 15.5 ≥ WMS-R

Exclusion Criteria:

* Diagnosed with major psychiatric or neurological disorder.
* A user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
Spinal Cord Stimulation and Functional MRI

The overall objective of this study is to assess patterns of fMRI cortical activation with spinal cord stimulation (SCS) in patients with neuropathic leg pain and therefore define cortical correlates, as well as to investigate cortical representations of pain and pain relief and the interactions therein, in the setting of neuropathic leg pain and SCS.

The main objective is to define, using functional magnetic resonance imaging, the effects of spinal cord stimulation (SCS) on cortical and subcortical BOLD effects in patients with neuropathic leg pain. Our hypothesis is that SCS will demonstrate a consistent pattern of BOLD activation that will correlate with symptomatic improvement.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-55 years at time of enrollment.
* Have previous implantation of thoracic epidural Medtronic Restore Ultra, Prime Advanced and Restore Advanced SCS in place for the treatment of CPRS-type 1 or chronic refractory neuropathic leg pain following FBSS. The implantation must be 3 or more months prior to enrollment.
* Patient must have reported significant pain improvement (\>50%) following implantation of the SCS.
* Have consistently reproducible pain relief (\> 50%) within 10 minutes of switching SCS from an OFF state to an ON state (with "optimal" parameters - see below).
* The SCS battery is implanted in the buttocks region.
* Unilateral or bilateral extremity pain.
* Able to provide informed consent.

Exclusion Criteria:

- Contraindication to MRI such as: SCS lead in the cervical epidural region Cardiac pacemaker Intracranial aneurysm clips, metallic implants or external clips within 10mm of the head Metallic foreign metals within the orbits Pregnancy; (urine pregnancy test will be done to confirm) Claustrophobia

* Pattern of response to spinal cord stimulation Inconsistent response of pain to spinal cord stimulation Long interval (\> 10 minutes) before pain relief following switching SCS from an OFF state to an ON state (with "optimal" parameters) - long "washout" period Lack of significant pain improvement (\< 50%) following implantation of SCS
* Positive history of significant brain lesions or pathology including:
* Prior ablative neurosurgery
* History of large vessel strokes or brain tumors
* Psychological Screening