cyrilzakka/clinical-trials huggingface dataset:
Optimizing Smoke-free Residential Housing Policies

This project will be conducted to investigate activities on housing-related health and safety issues. The focus of this project is the development of evidence-based approaches to implement smoke-free policies to reduce harms associated with exposure to secondhand smoke (SHS).

Chronic exposure to secondhand smoke (SHS) is a major health concern for public housing residents. While the prevalence of adult cigarette smoking in the United States has declined to 15.1% in 2015, recent data show that 34% of public housing residents still smoke. A federal rule issued by HUD now requires Public Housing Agencies (PHAs) to adopt a smoke-free policy to reduce SHS exposure. However, no evidence-based approaches are available to support post-adoption implementation by PHAs to ensure that the rule yields optimal benefits for residents. This research gap also applies to the larger population of affordable housing properties that are likely to adopt smoke-free rules in the future. The focus of this research is the development of evidence-based approaches to implement smoke-free policies to reduce harms associated with exposure to secondhand smoke (SHS).

The investigators will use six key implementation strategies identified in earlier research on the experiences of early-adopter PHAs. The investigators will partner with a for-profit affordable housing management company that recently expanded its portfolio with the acquisition of 55 affordable housing properties in Pennsylvania, Ohio, West Virginia, Virginia and Kentucky. This provides a unique opportunity to address the implementation research gap, because these properties are in geographic locations where the smoking rate is close to twice the national smoking rate. The for-profit affordable housing management company has committed to adopting a smoke-free policy in these properties, to go into effect in early 2020.

Using an established implementation science framework to guide the approach, the investigators will work with property managers and staff of properties located in five high-smoking states to strategically incorporate the six implementation strategies to reduce SHS exposure among affordable housing residents. The findings will provide accessible, practical, and effective evidence for property managers and staff to support ongoing efforts to optimize the impact of a smoke-free residential policy. The investigators will test this approach in a geographic region with high smoking rates and a disproportionate burden of tobacco-related mortality, covering western Pennsylvania, southern Ohio, West Virginia, Virginia and Kentucky.

Eligibility Criteria:
Property Manager Inclusion Criteria:

* Property Manager (or designated appointee) at one of the 12 selected sites implementing a smoke-free policy

Property Manager Exclusion Criteria:

* None

Resident Inclusion Criteria:

* Aged 18 and over
* A resident of the housing development (12 selected sites) implementing the smoke-free policy

Resident Exclusion Criteria:

* Unable/unwilling to complete surveys
ART-2 Pilot - Driving Pressure Limited Ventilation for Patients With ARDS

This is a multicenter randomized controlled pilot trial to investigate the feasibility of a driving pressure limited mechanical ventilation strategy compared to the ARDS Clinical Network strategy (conventional strategy) in patients with acute respiratory distress syndrome (ARDS).

Mechanical ventilation has the potential to produce or worsen alveolar injury. Driving pressure is the difference between plateau pressure and PEEP. Evidence from observational studies suggests that elevated driving pressure is the main independent determinant of ventilator-induced lung injury, however clinical trials are needed to establish whether targeting low driving pressures can improve clinical outcomes in patients with acute respiratory distress syndrome (ARDS). Thus, ART2pilot is a multicenter randomized controlled trial to assess the feasibility of a driving pressure limited mechanical ventilation strategy compared to the ARDS Clinical Network strategy (conventional strategy) in patients with ARDS. Patients considered to this trial are those in mechanical ventilation with diagnosis of ARDS of less than 72 hours duration. We will exclude patients with less than 18 years old; contraindication to hypercapnia such as intracranial hypertension or recent acute coronary syndrome; patients in which a high probability of death within 24 hours is anticipated and patients under exclusive palliative care. Eligible patients will be randomized to the driving pressure limited ventilation strategy or ARDSNet strategy. The primary outcome is driving pressure between days 1 and 3.

Eligibility Criteria:
Inclusion criteria:

* Patients on invasive mechanical ventilation with diagnosis of ARDS of less than 72 hours duration.

Exclusion criteria:

* Less than 18 years old.
* Presence of any contraindication to hypercapnia as suspected or confirmed intracranial hypertension or recent (\<7 days) acute coronary syndrome.
* Patients in which a high probability of death within 24 hours is anticipated.
* Patients under exclusive palliative care.
The Holding Study: Feeding Analgesia in Preterm Infants

The purpose of this study is to compare the effects of mothers' skin-to-skin holding during feeding via a soother trainer with the effects of pacifier sucking on preterm infant biobehavioural responses during and immediately after a painful procedure

Hypothesis:

1. When held by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier.
2. Following holding during the blood collection, mothers will find no differences in their infants' feeding ability.

Research Method:

In a between subjects, randomized design, 20 stable preterm infants born between 30-35 weeks gestational age will be studied. Infants will be randomized to one of two interventions which will take place during blood collections that are required for clinical management. For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection. For the holding condition, infants will be held skin-to-skin by their mothers and given breast milk using a soother trainer during the blood collection.

Eligibility Criteria:
Inclusion Criteria:

* Born between 30-35 weeks gestational age
* Mother has fluent English

Exclusion Criteria:

* CNS injury
* congenital anomaly
* active infection
* has had no surgeries or analgesics/sedatives in last 72 hours
* history of maternal drug exposure
Bedside Ultrasound to Measure Optic Nerve Sheath Diameter in Pediatric CSF Shunts

Bedside ultrasound in the emergency department is useful for quick assessments of patients. One growing use is to measure the optic nerve sheath diameter of patients for whom increased pressure in the head is a concern. This study will look at the optic nerve sheath diameters of a specific population of pediatric patients with shunts that drain extra fluid from their heads.

The particular interest of this study is the use of ultrasound to evaluate a child's optic nerve sheath diameter (ONSD), or the size of the covering around the nerve behind the eye. This covering expands when there is a higher than normal pressure inside the head. The group of interest on which this study focuses is the children with cerebrospinal shunts that drain extra fluid from their heads to other parts of the body (abdomen, heart, lungs) because the brain cannot drain all of the fluid like normal. When these shunts malfunction or fail, this can cause a backup of fluid in the brain, and raise the intracranial pressure (ICP) inside the skull. Depending on the degree of pressure buildup, this can be a surgical emergency due to pressure on the brain. Currently, computed tomography (CT) scans or magnetic resonance imaging (MRI) scans are used to diagnose the condition, but a quick screening tool, such as use of ultrasound to screen for elevated ICP in the emergency department, would be of great benefit to the patients to expedite care. Previous studies have explored the use of bedside ultrasound to evaluate the optic nerve sheath diameter in children with shunts. However, to date, there have been no reported prospective observational studies that compared before and after ultrasound measurements of the ONSD in patients in whom shunt failure is diagnosed and treated. Of note, this study is observational and the measurements taken with the ultrasound machine will not be used for clinical decision making. The measurements in this study will have no clinical impact on patient care. The use of ultrasound to measure the ONSD is an already accepted application of ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents, ages 6 months through 17 years who have a shunt and who present to the children's emergency department for evaluation and treatment.
* Children and adolescents, ages 6 months through 17 years who have a shunt and are directly admitted to the inpatient children's hospital from an outside facility.

Exclusion Criteria:

* Patients for whom the parents or guardians do not agree to participate in the study.
* Patients with any acute trauma to the eyes, face, or head.
* Severe anaphylactic allergy to ultrasound gel or Tegaderm
Vinorelbine and Gemcitabine Versus Capecitabine in Pretreated Metastatic Breast Cancer

The combination of vinorelbine and gemcitabine seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline. Capecitabine rescue monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline, also seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients. Whether the combination of vinorelbine and gemcitabine or capecitabine administration is preferable is not yet known, especially in patients with metastatic disease.

This trial will compare the efficacy of combination treatment with Vinorelbine and Gemcitabine versus Capecitabine monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline.

Eligibility Criteria:
Inclusion Criteria:

* Age 19-75 years.
* Performance status World Health Organization (WHO) 0-2.
* Histologically confirmed breast adenocarcinoma.
* Clinical or radiological evidence of metastatic disease that has progressed after combination treatment of a taxane and an anthracycline (Taxotere + Mitoxantrone or Taxotere + Farmorubicine).
* Measurable disease.
* No metastatic central nervous system (CNS) disease.
* Less than 25% of myeloproductive bone marrow irradiated.
* Adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9 gr/mm\^3).
* Adequate liver (bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function (creatinine \< 2 mg/dl).
* Informed consent.

Exclusion Criteria:

* Pregnancy or nursing.
* Positive pregnancy test.
* Psychiatric illness or social situation that would preclude study compliance.
* Other concurrent uncontrolled illness.
* Other invasive malignancy within the past 5 years except nonmelanoma skin cancer.
Neurostimulation to Treat Refractory Angina Pectoris Pain

The therapy under investigation involves an implanted Medtronic neurostimulation system to relieve symptoms of angina pectoris pain. Electrical impulses are applied to targeted areas of the spinal cord through an implanted lead (a flexible insulated wire) that is powered by an implanted battery.


Eligibility Criteria:
Inclusion Criteria:

* stable angina pectoris associated with reversible myocardial ischemia and significant coronary artery disease (CAD)
* classified as Canadian Cardiovascular Society (CCS) angina class III or IV
* refractory angina despite receiving optimal/maximal medical treatment
* not a candidate for bypass surgery, angioplasty or stent

Exclusion Criteria:

* not able to perform exercise treadmill testing
* previously received therapeutic transcutaneous electrical nerve stimulation (TENS) (within 2 years) or any spinal cord stimulation (SCS)
* has an implanted pacemaker/defibrillator (ICD)
Drug-drug Interaction Study of Dapagliflozin With Voglibose in Japanese Type 2 Diabetes Mellitus Patients

The purpose of this study is to evaluate the pharmacokinetics of dapagliflozin when administered alone or in combination with voglibose in Japanese patients with type 2 diabetes by assessment of AUC and Cmax of dapagliflozin


Eligibility Criteria:
Inclusion Criteria:

* Already on voglibose treatment with a steady dosage for at least 8 weeks
* Provision of informed consent prior to any study specific procedures
* Diagnosed with type 2 diabetes

Exclusion Criteria:

* Having clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological disease.
* The investigator(s)judged that the Subject should not participate in the study according to screening test or medical history.
A Comparison of Impingement Free Range of Motion With CT Scan After Manual and Robotic Total Hip Replacement

Single-blinded randomised controlled trial comparing impingement with CT scan for manual and robotic total hip replacement. A pilot study of 50 participants.

This will be a two-arm, single blind (assessor blind), randomised controlled group study. It will take place in the NHS hospital setting. Stratification will be performed for age and sex by means of a minimisation technique during randomisation for each subject entering the trial.

Arm 1: Manual total hip replacement with conventional templating Arm 2: Robotic total hip replacement In the study 25 participants will receive manual THR with conventional templating; the other 25 will receive Robotic THR.

Following recruitment in outpatient clinics, participants will undergo baseline assessments, including imaging and clinical assessment. All participants will then undergo THR surgery, which will likely entail an inpatient hospital stay of 1-2 days. Post-operative rehabilitation will be in line with the normal standard care for all participants. Post-operatively participants will make two visits to clinic at 6 weeks and 12 months (standard of care).

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the trial
* Male or Female, aged 18 to 85 years at recruitment into trial
* Diagnosed with hip OA, post-traumatic OA, inflammatory arthropathy, , or congenital or developmental hip disease, avascular necrosis of the hip
* Listed for total hip replacement
* Suitable for Accolade 2 stem and Trident cup prostheses
* Female participants of child bearing potential must be willing to ensure that they use effective contraception during the trial
* In the Investigator's opinion, is able and willing to comply with all trial requirements
* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.

Exclusion Criteria:

* Inability to provide informed consent
* Previous surgery to the ipsilateral hip and implantation of metalwork.
* Significant co-morbidities that would make follow up difficult or uncomfortable
* Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
* Pregnancy or intention to become pregnant within the trial period.
Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis

The aim of this monocentric randomized controlled intervention study is to improve visual function in persons with multiple sclerosis following optic neuritis (neuritis nervi optici) by means of a light stimulation.

In the treatment arm, two 80-second light stimulations are to be administered daily for 12 days in 25 persons with multiple sclerosis following recent optic neuritis (1-3 months). For the standardized application of light stimulation in the sense of standardized training, the light stimulation is to be carried out by watching a generated flicker video on a mobile phone. In a sham-intervened control group (sample size 25), the spontaneous course after optic neuritis will be recorded in parallel. Intensive neuronal stimulation of the visual pathway will be used to stimulate regenerative processes, which will be recorded by means of changes in high-contrast visual acuity (primary endpoint). Secondary endpoints are changes in a colored-contrast test, in 2.5% low contrast visual acuity, the peak conduction latency of visual evoked potentials, and retinal layer thicknesses and vessel densities measured in optical coherence tomography and optical coherence tomorgraphic angiography. These physiological parameters should help to understand the underlying processes of a potentially altered visual performance.


Eligibility Criteria:
Inclusion Criteria:

* Relapsing remitting multiple sclerosis or clinically isolated syndrome or no indication of chronic inflammatory central nervous system disease
* Age 18-60 years
* Optic neuritis within 1-3 months

Exclusion Criteria:

* Epilepsy
* Light-triggered migraine
* Insufficient vision correction
* Retinal disease (glaucoma, macular edema, macula degeneration, ...)
Seroprevalence of Pertussis Among Children and Adolescents in Croatia

Pertussis is a vaccine preventable disease caused by Bordetella pertussis. Older children and adolescents with pertussis continue to be a significant source of infection for incompletely vaccinated infants who are in harm for developing severe disease. The primary objective of our study is to estimate the duration of protection elicited by the current vaccination schedule against pertussis in Croatia.


Eligibility Criteria:
Inclusion Criteria:

* children and adolescents from 6 to 18 years of age treated through Emergency room and/or Day hospital of Pediatric Infectious Diseases Department at UHID;
* appropriate vaccination with pertussis component containing vaccine by date and at the appropriate time, according to Croatian NIP proven by insight in the Vaccination Record Card
* written informed consent obtained from the subject's parent or caregiver, as well as from participants ≥ 16 years old.

Exclusion Criteria:

* children under 6 years
* children and adolescents with acute respiratory symptoms
* children and adolescents with pertussis-like illness within 12 months
* children and adolescents with unknown, uncompleted or irregular vaccination record
* inpatients
* children and adolescents with immunodeficiencies
Optimizing Transhumeral Osseointegration Prosthesis Control

Upper limb amputation above the elbow results in a significant loss of function. There have been many advancements in surgery and prosthetic devices to restore arm function, but many people still reject upper limb prostheses. This is due to difficulties with how the socket fits and poor control of the device. Above-elbow prostheses are particularly challenging to use for several reasons. The socket must go all the way into the shoulder for stability. To hold the prosthesis onto the remaining arm, there needs to be a strap across the chest and shoulder. The prosthesis can be heavy, and the socket can slip or move around. This makes it hard to use muscle signals in the residual limb to control advanced prosthetic devices. People with limb loss are interested in advanced prostheses to use them reliably for day-to-day activities.

Bone-anchored prostheses (BAPs) are a new approach. They are for people with upper limb loss who can't use socket prostheses. The surgery involves putting a titanium rod into the remaining bone, which, over time, joins with the bone. This implant extends through the skin. It enables the direct attachment of the prosthetic parts (like the elbow and hand). With BAPs, there is no need for a socket. Also, there is a well-known surgery called "Targeted muscle reinnervation" (TMR). It improves the number of arm muscle control signals. These signals are used to control myoelectric prostheses. However, after both these surgeries, there is a lack of research that shows how best to train the muscle signals to use an advanced myoelectric arm and little evidence on what factors actually improve in a person's day-to-day life when using such a prosthesis.

This study aims to implement an enhanced muscle training protocol and fitting with a myoelectric (muscle signal-controlled) device after receiving OI and TMR for above-elbow amputation, and to evaluate the outcomes over time. The goal is to understand whether these advanced prostheses improve prosthesis use and function in daily life.


Eligibility Criteria:
Inclusion Criteria:

Individuals with transhumeral amputation who:

1. are between 18 and 65 years old,
2. have been scheduled to undergo osseointegration by the Alberta Limb Osseointegration Program.
3. demonstrate adequate pain-free shoulder range of motion to perform the required tasks and have potential muscle signals for myoelectric control to be able to undertake the muscle signal training
4. willing to undergo all of the study procedures and follow-up.

Exclusion Criteria:

Individuals who:

1. are unable to comply with treatment or follow-up processes,
2. are unable to understand English sufficiently to provide full informed consent.
3. have shoulder pathology on the side of the amputation (arthritis, adhesive capsulitis, chronic rotator cuff, or musculoskeletal dysfunction) that would negatively affect the ability to perform the training and functional assessments,
4. have insufficient muscle signals to operate a myoelectric prosthesis
Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections

The EAP is intended to provide a treatment option for patients with proven or probable serious or life-threatening invasive fungal infection (in accordance with the EORTC-MSGERC criteria) who have exhausted their treatment options, primarily due to an infection with a resistant fungal pathogen, and for whom no other treatment options are available through marketed drugs or investigational agents in clinical studies ongoing in the respective indication.


Eligibility Criteria:
The EAP is intended to provide a treatment option for patients with proven or probable serious or life-threatening invasive fungal infection (in accordance with the EORTC-MSGERC criteria) who have exhausted their treatment options, primarily due to an infection with a resistant fungal pathogen, and for whom no other treatment options are available through marketed drugs or investigational agents in clinical studies ongoing in the respective indication.