cyrilzakka/clinical-trials huggingface dataset:
The Role of Perturbed Auditory Information for Self-motion in Gait

As people walk and interact with objects such as when opening a door, their movements make sounds. It is possible that these sounds are also used as feedback to stabilize and adapt movement. There is some evidence for such a connection between the auditory and motor systems in activities of daily living, yet the empirical work is insufficient because the role of the auditory system in movement is a relatively neglected topic. The objective of this study is to address this gap. The study will also evaluate the potential for improvements in movement stability and variability by restricting or augmenting the auditory feedback from the participants' footstep sounds.

As people walk and interact with objects such as when opening a door, their movements make sounds. It is possible that these sounds are also used as feedback to stabilize and adapt movement. There is some evidence for such a connection between the auditory and motor systems in activities of daily living, yet the empirical work is insufficient because the role of the auditory system in movement is a relatively neglected topic. The objective of this study is to address this gap. The study will also evaluate the potential for improvements in movement stability and variability by restricting or augmenting the auditory feedback from the participants' footstep sounds. Eligibility is based on inclusion and exclusion criteria determined via a self-report questionnaire. The inclusion criteria are age and overall health status (young healthy adults, 19-35) and self-reported ability to walk comfortably for half an hour. Exclusion criteria include known hearing impairment, history of back or lower extremity injury, surgery that affects mobility, neurological disease or impairment that limits the ability to walk (Cerebral palsy). The study will randomly split the participants in a control and experimental group. Participants will perform trials in one condition only, quiet walking or control. Participants will visit the lab five times in the span of two weeks. The first and last sessions will serve for pre-post comparisons.

Eligibility Criteria:
Inclusion Criteria:

* self-reported tolerance to 30 minute exercise
* self-reported ability to walk comfortably for half an hour

Exclusion Criteria:

* known hearing or visual impairment
* currently being pregnant
* history of back or lower extremity injury, surgery that affects mobility, and neurological disease or impairment that limit the ability to walk
The Effect of Electronic Cigarette (ECIG) Liquid Vehicles on ECIG Acute Effects

This study examines the acute effects in ECIG users of the two primary vehicles in ECIG liquids, propylene glycol and vegetable glycerin. Thirty experienced ECIG users will use an ECIG in five conditions that will differ only by the propylene glycol:vegetable glycerin ratio: 100:0, 70:30, 50:50, 30:70, and 0:100 (device voltage, heater resistance, liquid nicotine concentration, puff number, and interpuff interval all will be held constant). Plasma nicotine concentration, subjective effects, and puffing behaviors will be recorded in each condition.

Electronic cigarettes (ECIGs) are among the most important issues in public health today due to their dramatic increase in popularity. However, very little is known about ECIGs, including what factors may make them more likely to be used and abused. Examining factors that influence nicotine yield, delivery, and subjective effects from ECIGs is essential to understanding their abuse liability. Limited pre-clinical research has revealed that nicotine yield may be influenced by the ratio of the two liquid vehicles, propylene glycol (PG) and vegetable glycerin (VG), most commonly found in ECIG solutions. Specifically, higher proportions of PG result in greater nicotine yields. However, the influence of PG:VG ratio on nicotine delivery and subjective effects associated with ECIG use has not been examined previously. The primary hypotheses are that higher proportions of PG will result in greater nicotine delivery and subjective effect profiles suggestive of higher abuse liability in ECIG users. Results from this project will result in further understanding of the factors that influence the abuse liability of ECIGs and could inform regulation of these products.

Eligibility Criteria:
Inclusion Criteria:

* Participants must use ≥1 ml of ECIG solution daily
* Must use ECIG solution with a nicotine concentration ≥12 mg/ml
* Must have used an ECIG for ≥3 months
* Must be willing to abstain from nicotine and tobacco products for ≥12 hours prior to each session.

Exclusion Criteria:

* History of chronic disease or psychiatric condition
* Regular use of a prescription medication
* Marijuana use \>10 and alcohol use \>25 days in the past 30
* Any other illicit drug use (e.g., cocaine, opioids) in the past 30 days.
* Positive test for pregnancy (by urinalysis)
* Daily use of \>5 conventional tobacco cigarettes
The Standard Concentration of Morphine as a Positive Control for Intradermal Skin Test

This study aims to compare skin reactivity results between morphine and histamine as a positive control agents in intradermal skin test.

Histamine hydrochloride and different concentrations of morphine sulfate will be intradermally injected and wheal diameter size will be comparatively measured between 15-30 minutes' time points after the test.

Eligibility Criteria:
Inclusion Criteria:

* age 18-60 years old

Exclusion Criteria:

* immunodeficiency state
* cancer
* severe skin diseases
* severe medical illnesses
* malnutrition
* uncontrolled asthma
* pregnancy
* received oral or systemic corticosteroid within 1 month before this study
* receiving immunosuppressive agents
* taken antihistamine within 3 days before this study
* taking beta-blocker
* previous history of immunotherapy
* have hypersensitivity reaction to morphine/opiates
Speech-to-speech Voice-cloning Care (SVCC) to Improve ICU-acquired Anxiety for Critically Ill Patients

The goal of this clinical trial is to learn the effect of Speech-to-speech Voice-Cloning Care (SVCC) on improving ICU-acquired anxiety for critically ill patients. The main question it aims to answer is:

* Can the use of participants' loved ones' voices by nurses in communication while providing care lead to better mental health and clinical outcomes?

Researchers will see if the implementation of SVCC can reduce anxiety and depression, and improve clinical outcomes.

Participants will:

* Receive the SVCC intervention until the endotracheal tube (ETT) is removed.
* Keep a diary of delirium, the duration of mechanical ventilation, and ICU stays.

During the SVCC, healthcare will be delivered by nurses who will communicate with participants using the familiar voices of their loved ones, transformed in real-time by an artificial intelligence voice-cloning tool.

Eligibility Criteria:
Inclusion Criteria:

* Expected mechanical ventilation time \> 24 hours;
* Expected ICU stay \> 72 hours;
* Language: Chinese;
* Richmond Agitation-Sedation Scale (RAAS) score ≥ -2 points;
* Hemodynamic stability.

Exclusion Criteria:

* Severe hearing impairment or worse (Grade 3 or higher according to WHO's Grades of hearing impairment);
* Disorders of consciousness or comprehension;
* Mental or psychological disorders that are being treated with medication;
* Head trauma or surgery resulting in an inability to wear earphones.
Cerebrovascular Registry

Patients with stroke were registered based on the WHO/ MONICA protocol and were followed-up for 28 days, starting in 2015 in PROVE Registry

PROVE program started in 2015, the registration of stroke continued but followed the WHO Stepwise method instead of WHO/MONICA .Patients are followed up for two years. The corresponding questionnaire covered the patients' demographic data, medical history upon hospital admission, history of comorbidities, medications used prior to the treatment, history of drug abuse, heart and brain imaging, history of blood tests and blood diseases, hospital treatments received, hospitalization complications, medications prescribed at the time of discharge, discharge status and the definite diagnosis of type of stroke according to CT or MRI.

The patients were followed-up over the phone or in person from the 1st, 3rd and 12th months to two years. The patients' disabilities were measured using the Barthel Index and the Modified Rankin Scale (MRS). The reliability and validity of these two questionnaires have already been investigated in Persian. In addition, secondary prevention measures, rehabilitation status and the incidence of new cardiovascular events were also examined in the follow-up. The stroke registration personnel received an initial training of three two-hour sessions and monthly one-hour retraining sessions. They visited the archives of various hospitals on a daily basis and registered the data contained in the records

Eligibility Criteria:
Inclusion Criteria:

\* patients with acute Stroke (Hemorrhagic and Non Hemorrhagic)

Exclusion Criteria:

* patients who do not agree to continue cooperation
* patients with incomplete documents
Effect of Norms on Laboratory and Imaging Testing (ENLITen)

Studies suggest that some laboratory tests ordered for hospitalized patients are duplicative or have limited value. This study will evaluate a normative feedback intervention to reduce overuse of laboratory tests for hospitalized patients by internal medicine physicians-in-training.

Past research has shown that 25% of diagnostic testing is duplicative or has limited value. Academic medical centers that employ physicians-in-training may find it particularly challenging to reduce low value testing due to a historical emphasis on extensive workups by trainees. Despite the increased emphasis on cost-consciousness in medical education, there is little existing research evaluating ways to optimize ordering behaviors of physicians-in-training. This study will evaluate a normative feedback intervention for internal medicine physicians-in-training to reduce overuse of routine laboratory tests for hospitalized patients. Physicians-in-training will be cluster-randomized into two arms: (1) those who receive report cards (intervention group), (2) those who will not receive report cards (control group). We will study the use of routine laboratory tests over a pre-intervention period of 1 week and a post-randomization period of 1 week. We will study physician attitudes about the real-time feedback dashboard with qualitative assessments in focus groups after the completion of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Any internal medicine physician-in-training scheduled to rotate through general medicine services at HUP during the study period will be included in the study.

Exclusion Criteria:

* Physicians-in-training pulled for weekend coverage or sick coverage will be excluded. Medical students will be excluded.
Limb-Girdle Muscular Dystrophy Type 2I in Norway

Key goals are to establish the natural history of limb-girdle muscular dystrophy type 2I (LGMD 2I) and identify feasible and sensitive tools and biomarkers to measure disease affection and progression, determine the Norwegian LGMD 2I prevalence, carrier frequency and genotypes, and to assess health-related quality of life in the Norwegian LGMD 2I population.

Main aims are to facilitate future clinical trials and contribute to good clinical practice with suitable methodology and to complete health and social care in order to optimize the function and quality of daily living of the patient group.

A single-center study with Norwegian nationwide enrollment. Data is based on questionnaires, patient journals, clinical examination, a set of functional tests and biomarkers, and patient reported outcomes. Clinical/ paraclinical tests are repeated after 2-years in order to measure disease progression. Both skeletal muscle, heart and respiratory function will be examined. At baseline there will also be performed a sleep study in order to find if they are prone to sleep-disordered breathing.

Eligibility Criteria:
Inclusion Criteria:

* Genetical confirmed limb-girdle muscular dystrophy type 2I in Norway
* Live in Norway
* Written consent

Exclusion Criteria:

* Children \< 16 years are excluded from the assessment of quality of life and from the clinical/paraclinical part, but may contribute with information through questionnaires and patient journal.

The study of prevalence and genotypes is anonymous and consent independent and will include everyone that is genetically LGMD 2I-confirmed in Norway.
Sepsis Electronic Prompting for Timely Intervention and Care for Emergency Department Patients

The goal of this clinical trial is to study systemic inflammatory response syndrome (SIRS) electronic health record (EHR) alerts for sepsis in the emergency department (ED). The main question it aims to answer is: do nurse alerts, prescribing clinician alerts, or both nurse and prescribing clinician alerts improve time to sepsis treatment for patients in the ED?

Nurses and prescribing clinicians will receive SIRS alerts based on the group to which the patient is randomly assigned. Researchers will compare four groups: no alerts, nurse alerts only, prescribing clinician alerts only, or both nurse and prescribing clinician alerts.

SEPTIC is a master protocol for two trials on distinct subpopulations: emergency department (ED) patients and inpatients. This protocol "ID: AAAU1002 - ED" describes the ED subpopulation study while "ID: AAAU1002 - IP" describes the inpatient subpopulation study.

Sepsis is a major cause of death both globally and in the United States. Early identification and treatment of sepsis are crucial for improving outcomes. International guidelines recommend hospital sepsis screening programs, which are commonly implemented in the electronic health record (EHR) as an interruptive screening alert based on systemic inflammatory response syndrome (SIRS) criteria. Despite widespread use, it is unknown whether these sepsis screening and alert tools improve the delivery of high-quality sepsis care. This study tests interruptive (pop-up) EHR alerts. Epic Systems, the company that produces the EHR, refers to these types of alerts as BestPractice Advisories (BPAs).

Eligibility Criteria:
Patient Inclusion Criteria:

* age \> 18 years-old
* meets SIRS criteria
* physically located in the emergency department
* not located in a hospital unit that takes care of pregnant and peri-partum patients
* not SARS-COV-2 PCR positive in past 7 days
* does not have an active order for "comfort measures only"

Patient Exclusion Criteria:

* already having sepsis treatment ordered (if prescribing clinician alert) or collected/completed (if nurse alert)
* already enrolled in the SEPTIC study (including as an emergency department patient or as an inpatient)
Bone Health Observational Study

Prostate Cancer patients treated with LHRH agonists (e.g., goserelin) lose Bone Mineral Density (BMD). Using a prospective, observational study design, we propose that monitoring how physicians manage Cancer Treatment Induced Bone Loss(CTIBL) in their patients. The gold standard for evaluating BMD is dual energy x-ray absorptiometry (DEXA). The proposed study will provide some of the first prospective data on the rates of Skeletal Related Events (SREs) in prostate cancer patients undergoing ADT and help develop official guidelines on the use of DEXA screening for prostate cancer patients.

A consequence of ADT is the gradual bone loss, so-called cancer treatment induced bone loss (CTIBL). The current standard of care is the addition of Vitamin D and Calcium upon the initiation of ADT. Moreover, bisphosphonates are now being considered to treat and prevent CTIBL. However, bisphosphonates are costly, thus there is a desire to identify or target a specific subset of patients who would most benefit from the treatment.

By obtaining baseline BMD and monitoring for Skeletal Related Events (SREs), we hope to identify that specific sub-set of patients who would most benefit from the treatment. Using a prospective, observational study design, we propose monitoring how physicians manage CTIBL in their patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients willing to provide written Informed Consent.
* Patients for whom Androgen Deprivation Therapy (ADT) with Zoladex® is indicated for at least 1 year.
* Patients started on Zoladex® within the last 4 months.

Exclusion Criteria:

* Patient had surgery or significant traumatic injury occurring within 1 month prior to consent.
* Known hypersensitivity to Goserelin Acetate or any of the components found in Zoladex®.
* Any concurrent condition that would make it undesirable, in the physician's opinion, for the subject to participate in the study or would jeopardize compliance with the protocol.
Carnitine Supplementation and Bone Mineral Density

The primary aim of the current research project is to explore whether carnitine supplementation and resistance training may prevent decrements in bone mineral density of aged women.

A secondary aim of this project is to investigate the effect of supplementation on body composition and blood markers.

The study includes postmenopausal women. The subjects participate in resistance training (twice a week) for each session consisted of 6 exercises: horizontal seated leg press, seated chest press, leg extension, shoulder press, lat pull-down seated row, seated cable row.

During the 24-weeks training programme participants are supplemented by carnitine with leucine, or leucine alone (placebo).

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal
* lack of restrictions to perform resistance exercises

Exclusion Criteria:

* cardiovascular disease
* liver disease
* kidney disease
* neuromuscular disease
* gastrointestinal disorders (including stomach ulcers and erosions)
* diabetes
* other severe chronic diseases
Lung Perfusion PET / CT Using Ga68-MAA for Preservation of Lung Function During Stereotactic Pulmonary Radiation Therapy

This is a prospective study evaluating the feasibility of treatment planning integrating lung perfusion PET/CT using Ga68-MAA to preserve functional lung areas during stereotactic body radiation therapy (SBRT).

Lung perfusion PET / CT is a new imaging modality based on the use of the same cold molecules as those used for a conventional perfusion lung scan. Similartly, perfusion images are obtained after intravenous administration of human albumin macroaggregates, which are embolized in pulmonary capillaries according to pulmonary blood flow. However, these cold molecules are radiolabeled, not with Technetium99m, but with Gallium68, a ß + isotope, allowing image acquisition with PET technology. The same physiological processes are therefore observed with conventional scintigraphy PET imaging, but PET is an intrinsically superior technique for image acquisition, with greater sensitivity, better spatial and temporal resolutions and the possibility to perform respiratory-gated acquisition, allowing a better definition of the pulmonary functional volumes.

The aim is to evaluate the feasability of functional lung avoidance planification using lung perfusion PET/CT imaging during SBRT.

Patients will benefit from a pre-treatment functional assessment including PET/CT imaging.

The treatment planning will be carried out in 2 stages:

* First, an anatomical planning will be carried out, blinded to the PET results.
* Then, a functional planning, respecting the standard constraints applied during anatomical planning, but also incorporating a new "functional lung volume" constraint defined by PET/CT images, will be carried out.

A follow-up will be carried out for 12 months, including repeated perfusion PET/CT imaging at 3 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Insured patient
* Patient treated at the Brest CHRU for SBRT of a primary or secondary pulmonary lesion

Exclusion Criteria:

* Unable/unwilling to give informed consent
* Pregnancy / breast-feeding patient
* Patient under guardianship or curatorship
* Patient with contraindication to the administration of macroaggregates of human albumin
Study to Assess the Efficacy and Safety of Raxone in LHON Patients

LEROS is an open-label interventional Phase IV study, designed to further assess the efficacy and safety of Raxone® in the long-term treatment of LHON patients.


Eligibility Criteria:
Inclusion Criteria:

1. Impaired visual acuity in affected eyes due to LHON
2. No explanation for visual loss besides LHON
3. Age more or equal 12 years
4. Onset of symptoms ≤5 years of Baseline
5. Confirmation of either G11778A, G3460A or T14484C LHON mtDNA (for the Intent-to Treat (ITT) population, not required for enrolment)
6. Written informed consent obtained from the patient
7. Ability and willingness to comply with study procedures and visits
8. Women of Childbearing Potential (WCBP) who have a negative urine or serum pregnancy test at Baseline visit and who are willing to use a highly effective contraceptive measure and maintain it until treatment discontinuation.

Exclusion Criteria:

1. Patient has provided natural history data to the Case Record Survey (SNT-CRS-002)
2. Any previous use of idebenone
3. Any other cause of visual impairment (e.g. glaucoma, diabetic retinopathy, AIDS related visual impairment, cataract, macular degeneration, etc.) or any active ocular disorder (uveitis, infections, inflammatory retinal disease, thyroid eye disease, etc.)
4. Known history of clinically significant elevations (greater than 3 times the upper limit of normal) of aspartate aminotransferase (AST), alanine transaminase (ALT) or creatinine
5. Patient has a condition or is in a situation which, in an investigator's opinion may put the patient at significant risk, may confound study results or may interfere significantly with the patient's participation in the study
6. Participation in another clinical trial of any investigational drug within 3 months prior to Baseline
7. Hypersensitivity to the active substance or to any of the following excipients (as listed in section 6.1 of Raxone SmPC): Lactose monohydrate, Microcrystalline cellulose, Croscarmellose sodium, Povidone K25, Magnesium stearate, Colloidal silica, Macrogol 3350, Poly(vinyl alcohol), Talc, Titanium dioxide, Sunset yellow FCF (E110).
8. Women who are pregnant or have a positive pregnancy test at Baseline visit
9. Women who are breastfeeding
A Phase 2 Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction

This is a double-blind, sham-controlled clinical study to evaluate the safety and feasibility of AMI MultiStem therapy in subjects who have had a heart attack (Non-ST elevation MI).


Eligibility Criteria:
Inclusion Criteria:

* Subjects of either gender, 18-85 years of age, inclusive
* Diagnosis of non-ST elevation myocardial infarction (NSTEMI)
* Left Ventricular Ejection Fraction (LVEF) between ≥ 25 and ≤ 45%

Exclusion Criteria:

* Previous Coronary Artery Bypass Graft (CABG)
* Previous autologous, allogeneic bone marrow or peripheral stem cell transplant
* Previous solid organ transplant
* Anticipated need for additional planned coronary revascularization procedure(s)
* Hemodynamic instability
* Mechanical complications of the index acute myocardial infarction