cyrilzakka/clinical-trials huggingface dataset:
Gaming Technology and Cardiac Rehabilitation

Moderate to vigorous physical activity has been shown to be associated with autonomic regulation of the heart measured with heart rate variability. Cardiac autonomic modulation can be evaluated by heart rate variability. Activity promoting games can be an effective tool to aid rehabilitation in clinical settings. Combining gaming with the ergo-cycle can facilitate improving patients' activity time spent on the cycle.

Physical activity is recognized as a central component of cardiac rehabilitation, improving control of cardiovascular risk factors, reducing the incidence of adverse events, leading to improvements in cardiovascular conditioning and prevention of thromboembolic events. Consequently, it provides greater physical independence and safety for hospital discharge. Coronary artery bypass grafting (CABG) surgery may lead to prolonged bed rest, and immobility, which can result in negative consequences, such as a decrease in functional capacity, decrease in muscle mass and muscle tone, postural hypotension, and changes in autonomic modulation of the heart rate. Cardiac autonomic modulation can be evaluated by heart rate variability (HRV), which involves simple noninvasive measurement of the oscillations in intervals between consecutive heartbeats.

Technology such as video games plays a complicated role in physical inactivity-much like a double-edged sword. To overcome this problem, the newly emerged active video games have been increasingly used to promote physical activity and health among various populations. Augmented reality games are unique because they integrate the physical and virtual worlds into a single interface using mobile devices applications. Investigators present a proof of concept of an endless running game called physio adventure which implements an activity recognition system that detects cycle rotation and its speed. The goal is to replace the traditional rehabilitation devices with innovative gaming technology with a more natural movement-based one, showing the potential of this kind of interaction to create innovative and immersive experiences while promoting physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Patients submitted to elective cardiac surgery (valvular or coronary bypass surgery by sternotomy)
* Both male and female
* a score of 15 on the Glasgow Coma Scale
* musculoskeletal, and cardiopulmonary conditions suitable for the accomplishment of the proposed activities
* absence of neurological sequelae and/or neurodegenerative diseases

Exclusion Criteria:

* Those who had difficulty understanding the activities involved in the study.
* those with any motor or neurological impairment that would prevent them from using a cycle ergometer.
* those who discontinued the protocol on the ward for return to the ICU
* previous cardiac surgeries
* hemodynamic instability that prevented protocol performance
* breathing discomfort
* invasive ventilatory support
* oxygen saturation below 90% (even with complementary oxygen therapy)
* coagulation disorders
* infections in any of the systems
* nonperformance of the whole protocol
Intensive Lifestyle Intervention for Type 2 Diabetics: The KP TLC Pilot

The purpose of this study is to determine if a healthy lifestyle intervention can significantly improve blood sugar control in type 2 diabetics over a course of 3 months.

Peer reviewed research studies have proven the benefits of lifestyle interventions including the reversal of coronary artery disease and of diabetes. Experts agree that such a lifestyle must include a diet rich in whole, grown foods while low in saturated fat and cholesterol; regular physical activity; and healthy ways to cope with stress.

There are several challenges with implementing such lifestyle interventions such as educating the general public and health care providers to the components of this lifestyle and in getting people to adopt these healthy lifestyle changes.

While retreat-style, intensive lifestyle programs have shown that these obstacles can be overcome, they require monetary and time investments generally not feasible for the general public.

A community-based, lifestyle program such as 'The Coronary Health Improvement Project' program offers similar potential benefits at a more reasonable cost. It does so through an intensive education (32 hours total) taught over 4 weeks, followed by an 8-week consolidation period which include live or DVD based group sessions, discussions led by a program facilitator, and medical monitoring.

Kaiser Permanente, the leading Health maintenance organization in the nation, places special focus and significant resources into preventive medicine and health promotion, providing services to thousands of plan members but none with the level of intensity of 'The Coronary Health Improvement Project'.

This study aims to determine if 'The Coronary Health Improvement Project' program can significantly improve blood sugar control in kaiser plan members with uncontrolled diabetes.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking patients \> 18 years of age, with at least 6 months of membership, who have type 2 diabetes.
* Patients must have a recent HbA1C lab value \> 8.0, and have had at least 2 previous HbA1C measures during the previous 6-12 months.
* Patients with HbA1C values that are consistently \> 8.0 over the previous 6-12 months will be invited to participate.

Exclusion Criteria:

1. current excessive alcohol use (drinking \> 14 alcohol beverages per week for men or \> 7 per week for women or \> 4 per day for men or \> 2 per day for women on 2 or more occasions each month)
2. current use of illegal or street drugs,
3. severely decreased functional capacity (shortness of breath or chest pain at rest or with minimal activity), and/or
4. suicidal thoughts or depression, will
5. Patients with severely limited physical ability
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Eligibility Criteria:
Inclusion Criteria:

* At least 2 month's history of nonmalignant pain, currently in stable pain control on opioid therapy.
* Good, very good or excellent pain control on current opioid therapy.
* Willing and able to use a telephone interactive voice response service.

Exclusion Criteria:

* Currently receiving daily morphine or oxycodone monotherapy.
* Scheduled for surgery of the disease site (eg, major joint replacement surgery), or any other major surgery, which would fall within the study period.

Other protocol-specific exclusion/inclusion criteria may apply.
A Study of Wrist Worn Accelerometers in End-Stage Renal Disease

The kidneys are important at getting rid of toxins and excess water from the body. If they fail, then toxins and excess water builds up within the body. Kidney failure is treated by either giving patients a new kidney (a transplant) or by removing the toxins and fluid from the body by the process of dialysis.

The investigators' aim is to personalise the care given to patients with kidney failure, and as such, they have started measuring the fitness of patients with kidney failure, who either already require dialysis or may need dialysis in the near future. This is currently done in a number of ways including measuring how strong their grip is, assessing their walking speed and asking questions about how difficult they find certain activities.

In the future, the investigators think that this will allow targeted treatments to help improve their fitness and potentially identify any problems earlier.

Current approaches to measuring activity and fitness have limitations and in particular may over- or underestimate the level of the physical activity. To over come these limitations, participants will be asked to wear an activity tracker (called an accelerometer) on for a week. Readings from the accelerometer will be compared against the other markers of fitness and activity to see if they are comparable. It will also be noted whether patients are prepared to wear the device for 7 days (compliance).


Eligibility Criteria:
Inclusion Criteria:

1. Aged over 18 years with low clearance pre-dialysis and referred to the Low Clearance Clinic with estimated Glomerular Filtration Rate (eGFR) less than 20 ml/min/1.73m and / or commenced on haemodialysis
2. Able to give informed consent

Exclusion Criteria:

1. Significant resting tremor of any aetiology or severe Parkinson's Disease
2. Immobile
3. Arteriovenous fistulas in both arms
4. Any scheduled inpatient treatment or day case treatment in next 7 days.
Vent Flow Study of Prototype Nasal CPAP Mask

As continuous positive airway pressure is the treatment choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance of a new mask system with diffuse vent technology. This is done by characterizing the mask flow over time and compare the performance between patients who apply 2 different washing procedures to the mask. The study will also subjectively assess breathing comfort and performance of the mask system.


Eligibility Criteria:
Inclusion Criteria:

* Participants willing to give written informed consent
* Participants who can read and comprehend English
* Participants using APAP for \>6 months
* Participants who are willing to use the mask system for the 3 month duration of the trial.
* Participants who are over 18 years of age
* Participants who currently use a nasal mask system

Exclusion Criteria:

* Participants not willing to give written informed consent
* Participants who cannot read and comprehend English
* Participants using an inappropriate mask system
* Participants on a Bilevel or ASV therapy
* Participants who are pregnant
* Participants with a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer lung injury; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection
* Participants or whose bed partner with implantable metallic implants in the head, neck and chest region affected by magmetic fields (Non-ferrous implants may be acceptable)
* Participants that weight \<30 kg
* Participants who are unsuitable to participate in the study in the opinion of the researcher
Characterization of Endothelial Dysfunction as a Function of Hyperaemia of the Brachial Artery During Cardiac Surgery

The glycocalyx is a layer of proteins and complex sugars covering the endothelium of vessels. Its role as capillary filtration control is important. In case of alteration of the glycocalyx, experimental models and some clinical studies show an increased capillary leak responsible for interstitial edema. The analysis of glycocalyx in routine care is important to guide volume expansion. Indeed, the literature provides evidence about the poor prognosis of excess water and its impact on organ. This analysis challenge is to justify filling solution of choice according to the characteristic of this capillary leakage.

Extra corporeal circulation and aortic clamp induce ischemia-reperfusion damages.

Vascular damages are represented by first glycocalyx, a layer of endovascular vessel proteoglycans, responsible for fluid permeability and secondly by nitro oxygen liberation responsible for vascular tonus.

The investigators suppose that both functions are impaired after cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* cardiac surgery

Exclusion Criteria:

* auricular fibrillation
* endocarditis
* aortic dissection
* end stage chronic renal disease
CMR Versus CT in Coronary Artery Disease

CONCORD is a prospective observational study evaluating the diagnostic accuracy of cardiovascular magnetic resonance (CMR) and computed tomography with fractional flow reserve (CT-FFR) in patients with suspected coronary artery disease, using invasive fractional flow reserve (FFR) as the reference standard.

In patients with suspected coronary artery disease (CAD), CT coronary angiography (CTCA) provides excellent sensitivity and negative predictive value, enabling the safe exclusion of significant CAD. However, its positive predictive value remains suboptimal (c.50%). Undertaking additional CT-FFR improves specificity and positive predictive value, reducing unnecessary invasive coronary angiography. It has been established that CMR perfusion imaging offers excellent diagnostic accuracy for the identification of functionally significant coronary artery disease. The diagnostic performance of qualitative CMR perfusion assessment may be further enhanced by additional quantitative assessment. The purpose of this prospective observational study is to evaluate the diagnostic performance of all three modalities (CT-FFR and qualitative and quantitative CMR perfusion imaging), involving 300 patients with suspected coronary artery disease referred for invasive coronary angiography. A subset of 167 subjects will undergo an additional accelerated CMR scan for comparison. Invasively measured fractional flow reserve (FFR) will serve as the reference standard.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years
* Referred for invasive coronary angiography for investigation of chest pain

Exclusion Criteria:

* Recent acute coronary syndrome (\< 6 months)
* Previous coronary artery bypass grafting
* Severe claustrophobia
* Absolute contraindications to CMR - those with MR conditional or safe devices will be included
* Second-/third-degree atrioventricular block
* Severe chronic obstructive pulmonary disease
* Moderate-severe asthma
* Estimated glomerular filtration rate \<30 ml/min/1.73m2
* Women who are pregnant, breast-feeding or of child-bearing potential( premenopausal women)
* Contraindication to iodinated contrast
* Participation in a research study involving an investigational product in the past 12 weeks
The Use of an Age-linked App for Parents During and After a NICU Stay

The main purpose of the neonatal intensive care unit (NICU) is to optimize the development of the newborn. Preterm children are at greater risk for developmental disorders. On the one hand, this is due to cerebral complications inherent to the prematurity, on the other hand it is related to the very early and therefore vulnerable stage of brain development at the time of the premature birth. The development of the child is also the result of a constant interaction between the infant and its environment, primarily the primary caregiver (i.e. the parents). A premature birth can cause great stress to parents, and there are several obstacles that can make it difficult to handle their child. Therefore, we have developed a web application that supports parents until their child reaches the age of two. By keeping them informed, we hope to make them more confident in their role as parents, and thus facilitate the parent-child interaction. In order to determine whether this form of support has an additional effect on the development of the premature child, we compare two groups of premature infants and a group of non-premature infants.


Eligibility Criteria:
Inclusion Criteria:

* Premature birth (\< 32 weeks)

Exclusion Criteria:

* The lack of internet access or a personal email account
* Little or no knowledge of Dutch in both parents
* Children with a congenital disease
Acceleration of Lower Anterior Teeth Leveling and Alignment Using Corticision

This experimental study will evaluate the effect of corticision on accelerating the leveling and alignment of lower crowded incisors compared with the control untreated group using cone beam computed tomography.

The study sample will consist of 26 patients with less than 6 mm crowding. The sample will be allocated randomly into two experimental groups.

The brackets and passive SS wire will be applied with radiographic metal guides between each tooth to allow for accurate corticision site 2 mm below the gingival papilla and to prevent tooth roots injury. The dentoalveolar changes occurring after leveling and alignment of lower anterior teeth will be evaluated using CBCT radiographs, Frequency, degree of root resorption, and the incidence of bone dehiscence will be assessed in relation to initial situation.

Crowding is the most common form of malocclusion. Different methods have been used to resolve crowding, including extraction and nonextraction. Corticision is an important methods to accelerate tooth movement in crowded cases. Cortical bone incision without flap elevation enhances turnover rate of surrounding structures and decreases the time for leveling and alignment. In orthodontics, CBCT imaging has been applied to evaluate impacted teeth and root resorption. But the data are very rare regarding the application of CBCT in tooth movement. So CBCT will be used in this research to evaluate the amount of external apical root resorption (EARR) and presence of dehiscence in the lower anterior teeth in the crowded cases. Furthermore, the duration of alignment will be compared between corticision group and non-corticision group.

Eligibility Criteria:
Inclusion Criteria:

* patients age 18 years or more
* complete permanent dentition with second molars
* crowding of less than 6 mm
* good healthy patients without systematic diseases
* absence of spaces in the lower dental arch
* orthodontic treatment protocol does not required extraoral appliances, intraoral elastics, and expansion during leveling and alignment in the lower arch
* good oral hygiene
* absence of periodontal lesion

Exclusion Criteria:

* patients with syndromes, clefts, or craniofacial abnormalities or systematic diseases
* poor oral hygiene or periodontal lesion
* previous orthodontic treatment.
* Inability for brackets bonding in lower anterior teeth
* presence of extreme skeletal discrepancy in vertical , transverse and anteroposterior relations
* Delay rebonding of any loosing brackets for more than one week in the lower anterior teeth
Immunogenicity and Safety Trial of Adjuvanted and Non-adjuvanted Trivalent Influenza Vaccine in Tropical Africa

This study will provide the Senegal Ministry of Health with data on the safety and immunogenicity of adjuvanted trivalent inactivated influenza vaccine (adjTIV) and full-dose seasonal non-adjuvanted trivalent inactivated influenza vaccine (TIV) in children. This data will inform future policy considerations for influenza vaccine. The study is not powered to detect significant differences between vaccines or groups, and no hypotheses are to be tested; therefore, immunogenicity and safety objectives are to be analyzed descriptively.

The is a phase 2b, single-center, randomized, observer-blind, parallel group, placebo-controlled trial of the immunogenicity and safety of adjTIV and seasonal TIV among healthy children aged 6 months through 71 months in the town of Niakhar, Senegal. A total of 300 healthy children will be randomized in a 2:2:1 ratio of adjTIV to TIV to placebo. Each child will receive two doses of one of the three study vaccines, with each dose given 28 days apart. Each child will be followed closely for safety after each dose for the period from one month post-dose two to 3 months post-dose two. For determination of immune response to vaccination or background influenza infection, 3 mL of blood will be obtained at three time points: pre-vaccination, 28 days post-dose one (prior to receipt of dose two), and at 28 days post-dose two. Serum anti-influenza antibodies produced against virus strains contained in the vaccine will be detected using hemagglutination inhibition assay.

Eligibility Criteria:
Inclusion Criteria:

* A male or female child at least 6 months of age and under 6 years of age (has not yet reached 72 months of age) at the enrollment visit.
* Free of obvious health problems, as established by the medical history and screening evaluations, including physical examination.
* Subject's parent or legal guardian is willing to provide written informed consent prior to the subject's first study vaccination.

Exclusion Criteria:

* Known hypersensitivity to any component in adjTIV or TIV (which include egg protein) or placebo.
* Receipt of any non-study vaccine within two weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 56 visit.
* Previous receipt of any influenza vaccine.
* Hypersensitivity after previous administration of any vaccine.
* Acute illness accompanied by a body temperature of 37.5°C or greater (axillary measurement) within 14 days of enrollment visit. (Enrollment and administration of adjTIV, TIV, or placebo should be postponed until at least 14 days after recovery. Minor illnesses, such as mild upper respiratory infection, with an axillary temperature of \<37.5°C, are not reason for exclusion or postponing study vaccination.)
* Any condition that, in the opinion of the investigator, would pose a health risk to the participant if he/she participates in the study or would interfere with the evaluation of the study objectives.
Modulation of Cortical Gamma Synchrony in Stroke

In the last decades, the research in neuroimaging-informed stroke prognosis and treatment has had a little clinical impact, often because of the costs of bringing complex procedures to the bedside. Cerebral stroke remains the leading cause of disability, with 65% of survivors chronically impaired at 6 months. Gamma synchrony (GS) is a fundamental mechanism of cortical function and can be estimated and modulated in a simple, inexpensive, and reliable way. It has provided valuable and cost-effective guidance in several neuropsychiatric conditions. In previous studies, we developed simple yet robust methods for assessing and manipulating GS and proved its relationship with clinical impairment in preliminary data.

The aim of the present project is to predict and improve stroke recovery by leveraging cortical mapping and modulation of GS via transcranial alternating current stimulation (tACS), a safe and inexpensive technique. The project capitalizes on technology readily available to the Italian national health system.

The project will consist of 3 Work Packages (WPs):

* The aim of WP1 is to map the relationship between GS and clinical outcomes with EEG.
* The aim of WP2 is to translate GS assessment and modulation to bedside.
* The aim of WP3 is to modulate GS to improve rehabilitation outcomes.

Eligibility Criteria:
The participants in this study will be 140 stroke patients rehabilitated at IRCCS San Camillo hospital. 80 will participate in the WP1 and the WP2, while 60 will participate in the WP3 study. In WP1, data will also be collected on 80 healthy volunteer participants, approximately the same age as the patients.

Inclusion Criteria (healthy participants)

- no neurological or psychiatric disorder

Inclusion Criteria (patients)

* right or left hemisphere damage
* unilateral stroke
* no comorbidities with psychiatric disorders

Exclusion Criteria (general):

* Diagnosis of epilepsy or family history up to the second degree with it
* Episodes of febrile convulsions or recurrent fainting
* Head trauma
* Presence of surgical clips or metal implants in the head
* Diagnosis of heart disease
* Presence of a cardiac pacemaker or artificial heart valve
* Presence of hearing aids/prostheses
* Hearing problems or tinnitus
* Vision problems not corrected with lenses (such as color blindness)
* Taking tricyclic antidepressant medications
* Taking neuroleptic medications
* Diagnosis of headache or migraine