cyrilzakka/clinical-trials huggingface dataset:
Human Factor Validation of Pediatric Mobility Device

The purpose of this study is to validate the user interface of a pediatric power mobility device by establishing that the product is safe and effective use for the intended users.

The purpose of this study is to validate the user interface of a pediatric power mobility device by establishing that the product is safe and effective use for the intended users. The human factors validation study will be conducted in children with mobility impairments as categorised by Hays (1987) in the age range of 6 months to 36 months under realistic use conditions.The study is an open label, un-blinded, non-randomized study which consists of one visit.

Eligibility Criteria:
Inclusion Criteria:

Primary users:

* Informed consent signed by parents or guardian
* Aged 6-36 months
* Unable to mobilize independently for exploratory play and peer interaction, as categorized by Hays (1987)
* Adequate trunk and head control to remain upright in the device, including regain head control
* Adequate hand/ arm (distal) control to reach for objects in front of them

Secondary users:

* Signed informed consent
* Physiotherapist/Occupational Therapist or parent/guardian of the child included in the test

Exclusion Criteria:

* Primary users:

  * Weight \>16 kg/35 Ibs
  * Length \>100 cm/39 In
  * Children that lack head control in such a severe manner that they cannot regain control if it is lost
  * Children who do not show awareness of or respond to toys, objects, sounds and/or people in their environment
  * Any other reason, if in the opinion of the investigator, the individual user is not appropriate, or suitable for participation in the test.

Secondary users:

* Hearing/vision loss or limited cognitive skills impacting the ability to take instructions and perform the tasks of the test
* Ability to understand oral and written English as product labelling will in this Human Factor validation test only be available in English
* Any other reason, if in the opinion of the investigator, the individual user is not appropriate, or suitable for participation in the test
Exercise for Patients With Renal Cell Cancer Receiving Sunitinib

In this randomized, controlled trial the investigators evaluate the effects of an exercise program lasting for 12 weeks on the physical performance, the cardiovascular function (24h blood pressure, rest blood pressure and hear function) and the fatigue and mood of patients with renal cell carcinoma undergoing a therapy with Sunitinib.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years
* Understanding of written German
* Treatment with Sunitinib
* Ability to walk

Exclusion Criteria:

* Cardiovascular, pulmonary or osteoarticular disease which can be aggravated by exercise
* BMI \< 18 or \> 30
ORCHID: An Online Intervention for Persons With HIV (Miami)

The purpose of this research is to test ORCHID (Optimizing Resilience \& Coping with HIV through Internet Delivery), a skills-building intervention that improves mental health status for persons with HIV, who are at-risk for falling out of care.


Eligibility Criteria:
Inclusion Criteria:

1. Cis-gender women,
2. Receiving human immunodeficiency virus (HIV) care at the University of Miami Women's HIV Service,
3. Recent history (12-month) of cervical or anal dysplasia or human papilloma virus (HPV) positivity; AND a recent (12-month) history of one or more of the following:

i) drug use (alcohol, tobacco products, marijuana, illicit drugs) or ii) depression or iii) psychiatric condition (anxiety, post-traumatic stress disorder (PTSD)) or iv) unsuppressed HIV viral load d. All life stages - pregnant, non-pregnant, pre/post-menopausal

Exclusion Criteria:

1. Under 18
2. Not able to read/write English at the 6th grade level
3. Cognitively impaired adults (as documented in medical records)
4. Debilitating psychiatric condition (e.g. schizophrenia/bi-polar/psychotic disorders)
5. Prisoners
Analysis of Imaging Features From Patients Treated With Brolucizumab in the Post-marketing Setting With Reports of Retinal Vasculitis and/or Retinal Vascular Occlusion

This non-interventional descriptive study was undertaken to better understand the most common imaging features associated with inflammation arising in the post-marketing setting when brolucizumab was prescribed in routine clinical practice.

The purpose of this retrospective study analysis was to better characterize the risk of inflammatory events arising from use of brolucizumab in routine clinical practice through analysis of independently reviewed ocular imaging data obtained from cases with reports of intraocular inflammation (IOI), retinal vasculitis (RV) and/or Retinal vascular occlusion (RO) and to provide a description of these features.

Whenever an AE report pertaining to RV and/or RO was reported to Novartis Patient Safety, a follow-up check list (targeted follow-up checklists \[TFUs\]) was sent by Novartis to the reporter. The reporter was encouraged to share all available images obtained as part of clinical practice, irrespective of the timing or event (i.e. images before, during, and after event could be provided). The focus and main efforts of this data collection was on adverse events of RV and/or RO; for other IOI only events, the images were not actively requested in the case documentation process, however in some cases these were spontaneously reported by the reporter.

All images obtained from Feb 2020 up to 31 Jan 2021 were reviewed in a standardized manner by an external reading center. Dedicated grading lists were developed for each of the image modalities: Fluorescein Angiography (FA), Fundus Photography (FP), Indocyanine Green Angiography (ICGA), Optical Coherence Tomography (OCT), and OCT Angiography (OCT-A).

Eligibility Criteria:
Inclusion Criteria:

* participants with cases of RV and/or RO reported to Novartis Patient Safety following brolucizumab use in routine clinical practice for which images were provided to Novartis and read by the Reading Centre
PDL and Fractional Photothermolysis for Postsurgical Scars

This is a two part study to evaluate the efficacy of early combined PDL (pulsed dye laser) and fractional photothermolysis in the cosmetic improvement of post surgical scars.All subjects will be offered at the time of the dermatologic procedure, an option to treat the post surgical scars with early combined PDL and fractional photothermolysis.

Part A is a non-randomized study design and subjects will have the choice of whether or not they will receive treatment. In part B, subjects will be randomized in a 2:1 treatment vs. control design.

The experimental group will have a total of 6 visits: 1 standard of care suture removal visit, 3 treatment visits and 2 follow up visits. The control group will have 3 visits: 1 standard of care suture removal visit and 2 follow up visits.

Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.

This study is a pilot study designed to determine feasibility of this procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females ≥ 18 years old
2. Fitzpatrick skin types I-VI
3. Subjects are in good health as judged by the investigator.
4. Subjects who have received dermatologic surgery procedure of the trunk or extremities closed with complex primary closure with subcuticular running suture removed at 2-3 weeks.
5. Subjects applying topical retinoids, must discontinue one week prior to treatment.
6. Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.

Exclusion Criteria:

1. History of recurrent facial or labial herpes simplex infection
2. Subjects applying topical retinoids, must discontinue one week prior to treatment.
3. Subjects with a history of hypertrophic scars or keloids
4. Pregnant or breast feeding
5. Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
6. Subjects who are unable to understand the protocol or give informed consent.
7. Subjects who in the opinion of the investigator are likely to have exaggerated scarring with laser treatments.
To Evaluate the Effect of AZD3199 on the Electrical Activity in the Heart

The purpose of this research study is to evaluate the effect of AZD3199 on the electrical activity of the heart. The effect of AZD3199 will be compared to a licensed antibiotic (moxifloxacin). Moxifloxacin effects on the electrical activity of the heart are well known. Safety and tolerability of AZD3199 and how much AZD3199 enters the blood circulation will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 18 to 45 years (inclusive)
* Have a body mass index (BMI) between 19 and 30 kg/m2 and a body weight between 60 and 100 kg.
* Be a non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start.
* Be able to inhale from the Turbuhaler inhaler according to given instructions.

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically relevant abnormal findings at screening examination
* History of additional risk factors for Torsade de Pointes (eg, heart failure, hypokalaemia, or family history of long QT syndrome).
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
Chronic Effects of Exercise on Motor Memory Consolidation in Elderly People

The main purpose of this study was to investigate if a six months period of physical exercise could improve motor memory consolidation in elderly people.

38 subjects of both genders, with a mean age of 71 years old participated in the study. Subjects were divided in two groups: a control group and an experimental group. Before the intervention of a physical exercise program, subjects performed a Finger Tapping Sequence to measure baseline performance. After the intervention, the assessment of the impact of exercise on motor memory consolidation was held in three stages: Training; 1 hour after training and 24 hours after training.

Eligibility Criteria:
Inclusion Criteria:

* individuals not engaged in physical activity;
* persons aged from 65 years.

Exclusion Criteria:

* sensory abnormalities;
* mental abnormalities;
* motor abnormalities;
* other atypical health problems.
Touch and Attention MRI Study

This study will measure resting state network central nervous system activity by functional magnetic resonance imaging (fMRI) during 4 separate interactions with a clinician. 1.

Hypothesis 1. Because they are different sensory systems, there will be different patterns of Mirror Neuron System (MNS)and Resting State Network (RSN) Central Nervous System (CNS) activity for visual vs. tactile stimulation, regardless of Loving Kindness Meditation (LKM).

Hypothesis 2. Because of unconscious, non-verbal signals, such as the practitioner's facial expression and respiratory rate, subjects' patterns of MNS and RSN CNS activity will differ for LKM+ vs. LKM- stimulation for both visual and tactile interventions.

Hypothesis 3. Because there is greater opportunity to detect signals from two sensory systems than one, the differences between CNS MNS and RSN activity patterns for LKM+ and LKM- will be greater for combined visual + tactile than for either visual or tactile stimulation alone.

This project builds on our previous research to build a platform for a successful NIH proposal to address a key gap in our understanding of the mechanism of non-verbal clinician-patient communication on physiology and behavior. Social neuroscience is a rapidly growing area of research that offers unique opportunities to better understand the mechanisms underlying common observations about clinician-patient interactions.The purpose of this study is to better understand the CNS mechanisms underlying the observed changes in self-reported well-being and ANS activity by evaluating resting fMRI activity under controlled conditions. The specific aims are to compare resting fMRI activity in the mirror neuron system (MNS) and resting state networks (RSN), reflected specifically in the Insula, Anterior Cingulate Cortex (ACC), Precuneus, Posterior Cingulate Cortex (PCC), Amygdala, Bilateral Inferior Parietal Cortex, Primary Motor-Visual System, and Dorsal Medulla while viewing touch with lovingkindness meditation lovingkindness meditation vs no lovingkindness meditation, receiving touch with lovingkindness meditation vs no lovingkindness meditation and both viewing and receiving touch with lovingkindness meditation vs no lovingkindness meditation. This is a descriptive study to generate sample size estimates for an NIH RO1 proposal.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years old
* healthy
* can understand and respond to verbal directions while in an MRI

Exclusion Criteria:

* blind
* undergone treatment for brain tumor, stroke, intracranial hemorrhage
* diabetes or any other form of peripheral neuropathy
* require a pacemaker, insulin pump or other electronic equipment
* taking beta blocking medications, systemic steroid medications or other medications likely to affect autonomic or central nervous system function
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Explorative Formulation of Insulin Degludec

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commerical formulation.


Eligibility Criteria:
Inclusion Criteria:

* HEALTHY SUBJECTS:
* Subjects will be healthy male subjects, who are considered to be generally healthy based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
* Body mass index (BMI) between 18.0-27.0 kg/m\^2 (both inclusive)
* SUBJECTS WITH TYPE 1 AND TYPE 2 DIABETES:
* Subjects will be male volunteers, who are considered to be generally healthy, except for the underlying diabetes mellitus, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
* Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months or diagnosed with type 2 diabetes mellitus for at least 12 months
* Body Mass Index (BMI) between 18.0-27.0 kg/m\^2 (both inclusive) for subjects with type 1 diabetes or 25.0-35.0 kg/m\^2 (both inclusive) for subjects with type 2 diabetes
* Glycogylated haemoglobin (HbA1c) maximum 8.5 % based on central laboratory results
* Subjects with type 2 diabetes must have been treated with insulin for the past 3 months prior to screening

Exclusion Criteria:

* Participation in any other trials involving investigational products within 3 months preceding the start of dosing
* History of significant multiple drug allergies or with a known allergy to the trial product or any medicine chemically related to the trial product, as judged by the investigator
* Hepatitis or carrier of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies or a positive result to the test for human immunodeficiency (HIV) antibodies
* Any clinically significant abnormal haematology or biochemistry screening tests, as judged by the investigator
* Subjects who have donated any blood or plasma in the past month or in excess of 1000 ml within the 12 weeks preceding screening
Text Messaging Reminders for Influenza Vaccine in Primary Care

Influenza morbidity and mortality cause a substantial financial burden to the NHS and to the UK as a whole. Influenza vaccine is safe and effective but is required annually because the circulating strain of virus changes each year. In the UK in 2012, the Chief Medical Officer (CMO) recommended that at least 75% of elderly people (aged 65+) and 75% people under 65 with certain chronic conditions (e.g. chronic heart disease, diabetes, asthma, etc) should be vaccinated. While primary care practices are achieving these targets for elderly patients, those set for younger patients with chronic conditions are not being met, with a third of patients being missed in the 2011/12 flu season and with no substantial improvements in uptake in the past decade. Therefore strategies to increase flu vaccine uptake in these patients are required.

Previous trials have shown that patient reminders can increase vaccine uptake and in particular, text messaging has shown to work in some populations in the United States as a cheap, simple and effective reminder. However, whether the same is true in UK general practice is unclear. The use of text messaging in the NHS for appointment reminders is also increasing as it is cheap, quick and effective. Text messaging is already used in roughly 30% of practices to remind patients about their flu vaccine but there has been no trial addressing its effectiveness. Therefore, we propose a trial of a text messaging flu vaccine reminder in patients aged under 65 who have a chronic condition. We hypothesise that practices that send a text message will have increased flu vaccine uptake.


Eligibility Criteria:
Inclusion Criteria:

* practices must use text messaging software to communicate with patients;
* practices must not have used a text message to remind patients aged under 65 about influenza vaccine in the 2012/13 influenza season.
* practices will send the text message to eligible patients who are aged between 18 and 65, with one of the following risk conditions: chronic respiratory disease, chronic liver disease, chronic kidney disease, chronic heart disease, chronic neurological disease, immunosuppression

Exclusion Criteria:

* practices will not send the text message to pregnant women.
A Study of Evacetrapib in Healthy Participants

The purpose of this study is to determine whether concentrations of the study drug (evacetrapib) in the blood stream is the same or is different when the person is also taking gemfibrozil (a drug used to lower lipid levels). Each participant will receive gemfibrozil alone, evacetrapib alone, and both drugs in combination. There is no washout period between doses. The safety of both of the study drugs given together will be evaluated. Information about any side effects that may have occurred will also be collected. This study will last approximately 36 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants as determined by medical history and physical examination
* Have a body mass index of 18 to 32 kilograms per square meter (kg/m\^2)

Exclusion Criteria:

* Have known allergies to evacetrapib and gemfibrozil, related compounds or any components of the formulation
* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Currently smoke cigarettes or use tobacco or nicotine substitutes
LOcally ABLatIve ThErapy for OligopRogressive Lung And Thoracic MalignanciEs (OBLITERATE)

This is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.

This is a phase 2 pragmatic study at a single site that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary endpoint is disease control at 3 months, defined as continuation in systemic cancer therapy without any changes or permanent discontinuation for 3 months following first day of ablative local therapy. Participants will receive ablative local therapy per standard practices in addition to their systemic therapy and will be followed for up to 5 years following ablative local therapy. Participants will be assigned stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy per the discretion of treating radiation oncologist and/or interventional radiologist.

Eligibility Criteria:
Inclusion Criteria:

1. Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies:

   1. Cohort A: Non-small cell cancer
   2. Cohort B: Small cell cancer
2. Provision of signed and dated informed consent form.
3. Stated willingness to comply with all study procedures and availability for the duration of the study.
4. Age ≥18 years at time of consent.
5. Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.
6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\]
7. ≤ 5 progressing or new metastatic lesions.
8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and/ interventional radiologist.

Exclusion Criteria:

1. Medical comorbidities precluding locally ablative therapies.
2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies.
3. Progressing intracranial lesions.
Human Centric Lighting to Improve Patient Sleep Parameters

Human centric lighting (HCL) is a technology that supports the body's circadian rhythm, as it can stimulate the sleep triggering hormone, melatonin, to improve sleep hygiene over standard lighting (SL), and promote recuperative sleep for a timely return-to-duty. In intensive care units, exposure to HCL has improved sleep measures. However, the effect in the medical surgical (MS) environment is unknown. The purpose of this study is to assess the feasibility of study procedures in MS setting and conduct a preliminary evaluation of the effect of light on inpatient sleep. Recruitment started November 2020 through April 2021. Data analysis is pending.


Eligibility Criteria:
Inclusion Criteria:

* Patient who is an active duty service member, GS Civilian, Dependent or Retiree affiliated with the Army, Air Force or Navy.
* Patient who is informed by provider or anticipates being admitted for at least two nights.
* Patient who can read and speak English fluently (since surveys are not translated in any other language).

Exclusion Criteria:

* Patient with visual impairment which cannot be corrected with glasses or contact lenses such as complete blindness, (defined as inability to see light), or partial blindness (defined as very limited vision) such as patients with history of cataracts.
* Patient taking an oral medication for sleep.
* Patient receiving radioactive ionization treatment.
* Patient who requires isolation or palliative care.
* Patient recovering from head/neck or oral maxillofacial surgery that would impede saliva sample collection (i.e. jaw wiring, extensive gauze packing in oral cavity)
* Patient who reports status as a Department of Defense Contractor at screening.