cyrilzakka/clinical-trials huggingface dataset:
Smart Pain Assesment Tool Based on Internet of Things

This study is the second phase of a research project called "Smart Pain Assessment Tool based on Internet-of-Things". During the course of this project, a smart pain assessment tool (SPA) to detect and assess pain employing behavioural and physiologic indicators will be developed. We aim to assess pain based on changes in electromyographic (EMG) activity in facial muscles, i.e. changes in facial expressions and simultaneously use physiologic signs such as heart rate, respiratory rate and galvanic skin response as adjuvant measures to develop an algorithm for pain assessment in critically ill patients.

The aim of this "smart pain assessment tool based on internet of things" SPA-research project is to develop an automatic and versatile pain assessment tool algorithm for detection and assessment of pain in a reliable and objective way in non-communicative patients. The final objective of the research project is to develop a smart pain assessment tool to detect and assess pain employing behavioural and physiologic indicators for a wide range of users/patients from infants to elderly people who are unable to communicate normally. The research project consists of three clinical phases (European Commision. Meddev 2.7/4/2010). The clinical phase I of the research project focused on developing pain assessment techniques involuntary working-age healthy study subjects. This current Clinical phase II includes the further development and research of the smart pain assessment tool in elective (non emergency) postoperative surgical patients during their stay after surgery in a recovery room.

Eligibility Criteria:
Inclusion Criteria:

* Subject is scheduled for major surgery that requires general anesthesia and is likely to cause moderate to severe pain postoperatively which needs to be treated with systemic analgesics
* Ability to communicate
* Written informed consent
* Healthy facial skin

Exclusion Criteria:

* Subject treated with local anesthesia during surgery
* Any diagnosed condition affecting cognitive functions
* Surgery affecting hands where pulse oximetry and galvanic skin reaction are recorded or areas where facial muscle activity is measured
* Any diagnosed condition affecting central nervous system, facial nerves or muscles.
* Significant facial hair growth in the area where the sensors will be attached
* Tattoos in the area where the sensors will be attached
Pupil Dynamics and Color Vision for the Detection of Eye Diseases

The development of new oculometry techniques allows fine and dynamic measurements of pupillary diameter and use in routine clinical practice.

The preliminary results obtained with innovative devices on healthy sjuets make it possible to envisage a clinical study on a population of patients suffering from retinal pathologies.

This is a "proof of concept" study, which, if the expected results are confirmed, will make it possible to consider a study on a larger population, as well as the industrial development of a commercial device.

This is a single-head study that will take place at the National Ophthalmology Hospital Center (CHNO) and the Vision Institute (Streetlab) and the total duration of the study is 24 months .

It is planned to include 60 participants divided into different groups:

* 15 healthy subjects, called controls.
* 15 patients with retinitis pigmentosa.
* 15 patients with Leber's hereditary optic neuropathy.
* 15 patients with Stargardt's disease.

Patients will be pre-selected on files at the CHNO clinical investigation center based on the visual assessment carried out on the day of their arrival, the doctor may suggest that they participate in the study if the inclusion criteria are respected.

The control subjects will be recruited thanks to the database of the Vision Institute at Streetlab.

Eligibility Criteria:
Inclusion Criteria:

- Patients with an understanding of the French language to ensure a perfect understanding of the instructions during evaluations and documents relating to their involvement in the study.

Visually impaired volunteers:

Patients must have one of three conditions: Retinitis Pigmentosa, Stargardt disease, Leber optic neuropathy.

Healthy volunteers:

* Visual acuity of both corrected eyes (glasses) should be higher or equal 8/10th and a normal visual field.
* Patients should not wear contact lenses (which may interfere with the recording of the pupil and eye movements)

Exclusion Criteria:

* Pregnant or lactating women will not be able to participate in this research.
* Participants should not be unable to personally consent.
* Subjects should not participate in another clinical trial that may interfere with this research.
* Inability to personally consent.
* Subjects should not present with degenerative diseases or any other disease that could interfere with the evaluations planned during this study.
* The subject follows a drug treatment which can cause visual disturbances, changes in pupillary kinetics or cognitive disturbances.

Secondary exclusion criteria (at the end of the inclusion visit):

* Visually impaired subjects and controls for which calibration is not feasible.
* Patients and control subjects having difficulty maintaining visual fixation.
* Patients and subjects wearing corrective lenses making it impossible to record oculomotor activity with an infrared camera oculometer.
A Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis

This study seeks to evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of ABT-555 in participants with relapsing forms of multiple sclerosis (RFMS).


Eligibility Criteria:
Inclusion Criteria:

* Currently receiving one of the following MS medications for at least 3 months: beta-interferon (any formulation including the pegylated form), glatiramer acetate (Copaxone®, others), teriflunomide (Aubagio®), fingolimod (Gilenya®), or dimethyl fumarate (Tecfidera®); OR
* Has not been treated with an MS immunotherapy for the past 6 months (12 months if they previously received cyclophosphamide or alemtuzumab); OR
* Treatment naïve with established MS diagnosis per criteria by a neurologist.
* Diagnosis of relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) according to revised McDonald criteria
* Baseline Expanded Disability Status Scale (EDSS) between 0 and 6.0, inclusive.
* Brain MRI scan at Screening that did not show evidence of overt vascular lesions, masses, mass effect or other abnormalities other than those compatible with MS, which would preclude the participant from undergoing a lumbar puncture/spinal tap for CSF collection

Exclusion Criteria:

* Diagnosis of primary progressive MS.
* Anticipated maintenance immunomodulator change, either agent or dose
* An MS relapse that occurred within the 30 days prior to randomization AND/OR the participant has not stabilized from a previous relapse prior to randomization
* Participants for whom MRI is contraindicated
* Participants who have claustrophobia that cannot be medically managed or are unable to lie still for 1 hour or more for the imaging procedures
* Findings on brain MRI scan indicating any clinically significant brain abnormality other than MS
* Contraindication for lumbar puncture
Oxandrolone Multiligament Knee

This study is about healing after a rmultiligament knee reconstruction procedure. We hope to learn if a biologic medication: Oxandrolone, a synthetic derivative of the human hormone Testosterone (the principal male sex hormone and an anabolic steroid), given for 12 weeks is effective in aiding in the healing process and restoring muscle mass.


Eligibility Criteria:
Inclusion Criteria:

• Patients with MRI proven multiligament knee injury scheduled to undergo multiligament knee reconstruction

Exclusion Criteria:

* Patients with prior ipsilateral knee surgery
* Untreated diabetes mellitus
* Pituitary tumor
* Rheumatoid Arthritis
* Uncontrolled hypertension
* Congestive Heart Failure
* Myocardial Infarction within the past 6 months
* End-stage renal disease
* Liver enzymes two times the normal value
* DVT within the past 6 months
* Disorder of the coagulation system
* Currently taking anticoagulation
* Prior or current use of anabolic steroids
* Chromosomal disorders
* Prostate cancer
* Breast cancer
* Hypercalcemia
* Patients with COPD not responsive to bronchodilators
* Patients with known liver disease
* Patients at risk for liver tumors
* Severe hyperlipidemia
* Patients taking medications that interfere with testosterone production or function, including but not limited to 5α-reductase inhibitors, acetaminophen (Tylenol, others), cholesterol lowering
Diet and Fat Mass After Traumatic Spinal Cord Injury

This is a randomized clinical controlled trial (RCT) to investigate the impact of a personalized nutritional intervention on functional and clinical outcomes the first year after traumatic spinal cord injury. The long term goal is to prevent gain of body fat mass and obesity.

Traumatic spinal cord injury (SCI) is a devastating injury resulting from critical incidents like falls, sports- and traffic accidents, demanding lifelong specialist health care services. A major challenge is the prevalence of obesity following metabolic alterations after SCI. Obesity hampers independence and mobility and has a negative impact on quality of life. Accumulation of adipose tissue is reported to be higher than in able-bodied, explaining the high risk of cardiometabolic disease in the SCI population. Food intake is the supreme variable in prevention of obesity after SCI, however there is a paucity in studies investigating nutrition as a measure to prevent and reduce comorbidity. Key questions that remains unanswered are how early adipose tissue accumulates, if nutritional manipulations can prevent obesity and how follow-up can help maintain a healthy lifestyle. In the present PhD-study, we use MRI techniques to quantify changes in body composition in a cohort study the first year after SCI, and we employ a randomized controlled trial to test the efficacy of a nutrition intervention during rehabilitation aiming to prevent obesity. Successful results will be implemented in care-programs at our hospital for those with SCI and similar mobility impairments, with the aim of improving nutrition practice throughout the course of treatment

Eligibility Criteria:
Inclusion Criteria:

* Traumatic spinal cord injury
* Levels C1-L2
* American Spinal Injury Association (ASIA) Impairments Scale (AIS) A-D

Exclusion Criteria:

* Glasgow Coma Scale score (GCS) equal to or lower than 13
* Below 18 years of age
* Medical issues like impaired cognitive function, progressive disorders and co-morbidities.
Clinical and Radiological Outcomes of Oblique Lateral Lumbar Interbody Fusion

This study is undertaken to evaluate the outcomes of Oblique Lateral Lumbar Interbody Fusion (OLLIF). Specifically, the study seeks to measure outcomes on radiological imaging, outcomes reported by the patients on standardized questionnaires, and complication rates.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis, confirmed by imaging, of one of the following conditions: severe degenerative disc disease, spondylolisthesis, spinal stenosis, disc herniation
* Completion of a full course of conservative therapy. Conservative therapy may include physical therapy, therapeutic injections, bracing and behavioral modification.

Exclusion Criteria:

* bony obstruction of the approach
* significant spinal canal stenosis
* large facet hypertrophy
* grade II listhesis
* scoliosis with Cobb angle \> 10º
* Patients who underwent procedures that were converted to open fusions
Biofeedback Intervention in Rehabilitation of Adolescence With Posterior Sagittal Anorectoplasty

most of children undergo Posterior Sagittal Anorectoplasty Complain from faecal incontinence and faecal soiling which negatively impacts the social life of these children prohibiting their participation with their bears.

most of children undergo Posterior Sagittal Anorectoplasty Complain from faecal incontinence and faecal soiling which negatively impacts the social life of these children prohibiting their participation with their bears so this study aims prevent faecal incontinence so continue life time without any interference with social life and activities

Eligibility Criteria:
Inclusion Criteria:

* Age from 10-13 years old
* Reliable females
* Able to understand verbal commands
* Normal vision and hearing

Exclusion Criteria:

* Neuromuscular or musculoskeletal disorders
* Behavioural disorders
* Psychological disorders
Biomarkers for Length of Hospital Stay and Loss of Muscle Mass and Function in Old Medical Patients

As humans age, there is a gradual loss of skeletal muscle mass and strength, termed sarcopenia. The underlying causes of sarcopenia are yet not fully elucidated but are thought to be multifactorial and include increased levels of systemic pro-inflammatory mediators, a decrease in anabolic hormones and changes in the neuromuscular system. Furthermore, physical inactivity, chronic diseases, immobilisation and hospitalisation are known to play an important part in the development of sarcopenia.

The prevalence of sarcopenia ranges from 20-30% (aged \>70yrs) within the general community. However, the prevalence of sarcopenia in geriatric patients after an acute hospital admission is substantially higher, estimated at ≈50%. Furthermore, successive events of hospitalisation have been suggested to contribute to the development of sarcopenia, as even short periods (4-5 days) of skeletal muscle disuse are known to induce muscle atrophy.

Mean length of hospital stay in geriatric wards due to acute illness or hip-fracture is typically 7 to 11 days during which the level of physical activity is strongly reduced leading to an accelerated loss of muscle mass that many older patients never recover from.

Notably, a substantial part of the deterioration in functional capacity could be avoided just by counteracting loss of muscle mass during hospitalization. As such, we need to identify sensitive biological, clinical and functional biomarkers predicting loss of muscle mass and function during hospitalization to identify patients at risk of developing sarcopenia. Additionally, it is crucial to investigate the association of these biomarkers with hospital length of stay, as hospitalisation has been suggested to contribute to the development of sarcopenia while longer hospital stays may increase patient risk of hospital-acquired infections and place an economic burden on society.


Eligibility Criteria:
Inclusion Criteria:

* equal to or over the age of 65
* admitted to the acute ward at Bispebjerg Hospital

Exclusion Criteria:

* age under 65 years
* terminal illness
* participants who do not understand Danish
* participants in isolation with airborne or droplet infections
FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial

The purpose of this clinical trial is to analyze patency after autologous infrainguinal bypass surgery in patients receiving a venous conduit versus a covered venous conduit.

Patients presenting to Vascular Surgical Units are usually multimorbid with increased cardiopulmonary risk. Autologous venous bypass is indicated in certain situations despite the longer duration of surgery. Optimizing patency has been an important goal since many years. Reconstruction problems are often based on intimal hyperplasia, which can be reduced via covering of the harvested vein as seen in previous studies.

This clinical trial will be conducted at our Division of Vascular Surgery and Endovascular Surgery at the University Hospital of Salzburg. Patients will be randomized into one of the two treatment options, which are a plain venous conduit or a by mesh covered venous conduit. During this clinical trial, the first follow-up will take place after 6 weeks; this corresponds to the usual follow-up interval. Due to the trial, further follow-ups will take place for each of the patients after 3 months, 6 months, 12 months, 2 years.

Eligibility Criteria:
Inclusion Criteria

* Age at least 18 years
* Informed consent form with signature
* Rutherford Category 3 (\<200m) or chronic critical ischemia (Rutherford Category 4-6)
* Assured inflow and recipient artery.

Exclusion Criteria

* Pregnant or breastfeeding women
* Active infection or sepsis
* Acute ischemia
* Endovascular procedure in the region to be treated.
* Vein with outer diameter \<3.5 mm or \>8 mm under pressure.
* Spliced Veins.
* Known allergy to the cobalt-chromium alloy (ASTM 1058) or its components (Cobalt-Chromium-Iron-Nickel-Molybdenum).
* Vasculitis
* Coagulopathy
* Radiation therapy near the anastomosis
Plantar Fascia Release With Magnetic Fascia Ball

In this study, the effect of plantar fascia release with a magnetic fascial cork ball on hamstring and lumbar extensor muscle elasticity will be investigated.

The use of tools such as foam rollers or massage balls to resolve myofascial tension is highly preferred by both therapists and patients. It is theorized that the sweeping pressure generated during rolling causes the fascia to stretch and increase the range of motion. In addition, the warming caused by the friction during rolling can dissolve the adhesions between the fascial layers and restore the elasticity of the myofascial tissues. In addition to similar mechanical effects, the use of cork balls with magnetic properties is becoming increasingly common. Studies have shown that static magnetic magnets reduce pain, increase microcirculation and oxygenation and cause changes in presynaptic membrane function. As far as we know, there is no study examining the myofascial relaxation effect of magnetic balls in the literature. Evaluating the clinical impact and efficacy of this device which allow the person to perform self-massage might contribute the current literature. This study was planned to evaluate the myofascial relaxation caused by two different fascial cork balls with and without magnetic properties.

Eligibility Criteria:
Inclusion Criteria:

* Having scored 3 or less according to the Beighton scoring system
* 18-35 years old,
* Having asymptomatic
* Voluntary participation in the research

Exclusion Criteria:

* Having Beighton score of 4 and above
* Having history of previous surgery
* Having diagnosed pathology of the lower extremities and lumbar region
Efficacy and Safety of Rebel Reliever Brace in Patients With Symptomatic Medial Knee Osteoarthritis

The purpose of the study is to evaluate the superiority of Rebel Reliever® knee brace + standard treatment versus standard treatment alone in terms of last 24-hour pain relief after 6 weeks. in patients with medial knee osteoarthritis.

The main criteria is the evaluation of global knee pain during the last 24 hours at D 49 after the inclusion.

The response to the treatment will be evaluated during the inclusion visit (V1/D0) and after 6 weeks of treatment, during the following visit (V3/D49).

The level of the global pain of the patient during the last 24 hours will be collected by investigators with a VAS (0 mm = no pain ; 100mm = maximun pain) at each visit.

Eligibility Criteria:
Main Inclusion Criteria:

* Male or female over 18 years
* BMI \< or egal to 35kg/m2
* symptomatic gonarthrose defined by a recurrent pain to the walk on 30 days during the last 2 months before the inclusion with radiological findings (grade II to IV on Kellgren-Lawrence)
* diagnosis of medial femoro-tibial knee osteoarthrosis
* patient with global pain intensity during the last 24hours \> or egal 40 mm (EVA) at the day of selection

Main Exclusion Criteria:

* femoro-patellar predominant arthrosis
* septic arthritis
* metabolic arthropathies
* chronical rheumatismal diseases
* other knee diseases
* symptomatic coxarthrosis
* controlateral gonathrosis with corticoids injections
* any other serious disease which may interfere with the results
* psychiatrics disorders
* skin lesions or dermal pathologies
* venous or arterial disorders
* sensitivity disorders in the lower limbs (diabetes mellitus..)
* paracetamol intolerance
* hyaluronic acid or corticosteroid intra-articular injection in the last month prior to inclusion
* on going knee viscosupplementation at inclusion
* slow acting OA drugs (if started in the last 2 months prior to inclusion)
* opioids, corticosteroids, or NSAIDs intake in the last 48 hours prior to inclusion
* pregnant women of with no contraception
* hepatic or renal insufficiency
Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers

The purpose of this Phase 2a, randomized, blinded, placebo-controlled, multi-center study is to evaluate the safety, tolerability and immunogenicity of INO-4700 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA™ 2000 device in healthy adult volunteers for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection. This study is divided into 2 parts: Part 1- dose finding stage and Part 2- dose expansion stage.


Eligibility Criteria:
Key Inclusion Criteria:

* Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at Screening;
* Able and willing to comply with all study procedures;
* Screening laboratory results within normal limits;
* Negative tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody;
* Screening electrocardiogram (ECG) deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome);
* Be post-menopausal or be surgically sterile or have a partner who is sterile or use medically effective contraception with a failure rate of \< 1% per year when used consistently and correctly from screening until 3 months following last dose.

Key Exclusion Criteria:

* Pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until 3 months following last dose;
* History of respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD) or chronic bronchitis;
* Currently participating in or has participated in a study with an investigational product within 30 days preceding Day 0;
* Previous receipt of any vaccine within 30 days preceding Day 0 or planning to receive any vaccine during the timeframe restricted per the protocol;
* Previous receipt of an investigational vaccine product for the prevention of MERS;
* Prior exposure to MERS-CoV or camels;
* Participants who participate in MERS-201 Part 1 cannot participate in MERS-201 Part 2;
* Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles;
* Prisoner or participants who are compulsorily detained (involuntary incarceration);
* Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids) prior to dosing. Systemic corticosteroids must be discontinued at least 3 months prior to first dose;
* Reported active drug or alcohol or substance abuse or dependence.