Kornimate/medical-research-clean huggingface dataset:
a wearable "balance booster" - stepping closer to the market

Conditions: Distorted; Balance; Sensation Disorders; Peripheral Neuropathy; Neuropathy

Summary: the overall goal of this project is to continue development and commercialization of a wearable sensory prosthesis termed walkasins. the device measures foot pressure through a thin sole insert, developed under national institute on aging (nia) small business innovation research (sbir) phase i funding, and displays pressure information through a vibrotactile feedback array, placed around the lower leg, to help improve balance function. the device can replace lost foot pressure sensation in individuals with peripheral neuropathy who have balance problems.

our specific aims are to: 1. revise and finalize design of walkasins® based on accomplishments, user input, as well as reviewer criticism from our phase 1 grant and manufacture 200 units of the device for clinical testing. milestone 1: 200 units manufactured and ready for clinical testing under aim 2. this goal is accomplished. 2. investigate effects of using walkasins on clinical outcomes related to gait, balance function and associated fall risk in a population of patients with sensory peripheral neuropathy and balance problems. hypotheses 1a-b: patients who are trained to use walkasins programmed to display relevant balance cues will attain higher gait speed and functional gait assessment when compared to a matched cohort not using walkasins. milestone 2: data collection to assess clinical utility and safety of the walkasins on patients briefly trained to use the device has been completed.

Eligibility criteria:
inclusion criteria: * patients of any age diagnosed with peripheral neuropathy and who experience balance problems. * ability to perceive the walkasins vibration feedback, understand and physically act on the vibration feedback. exclusion criteria: * vibration to the skin is contraindicated by physician * use of ankle foot orthotic that prevents attachment of walkasins device * foot size smaller than woman's 5 or larger than men's 13
study to evaluate a single dose of sti-2020 (covi-amg™) in hospitalized adults with covid-19

Conditions: Covid19

Summary: this is a placebo-controlled study to investigate the safety and efficacy of a single injection of covi-amg in inpatient adults with covid-19.

this is a multi-center, randomized, double-blind, placebo-controlled study designed to investigate the safety and efficacy of a single injection of covi-amg in inpatient adults with covid-19. subjects will receive 100 mg of covi-amg, 200 mg of covi-amg, or placebo via slow iv push. subjects will be followed for approximately 70 days post dosing.

Eligibility criteria:
inclusion criteria: * positive for covid-19 by an approved antigen test * progressive disease suggestive of ongoing covid-19 infection * requires hospitalization for acute medical care * provides written informed consent * willing to follow contraception guidelines during study exclusion criteria: * requires high-flow oxygen supplementation * current or imminent respiratory failure * has rapidly progressing symptoms that in the investigator's opinion are likely to progress to needing high-flow oxygen or to respiratory failure within 24 to 48 hours * any condition which, in the investigator's opinion, participation would not be in the subject's best interest or could prevent, limit, or confound the protocol-specified assessments * has participated, or is participating in, a clinical research study evaluating covid-19 convalescent plasma, monoclonal antibodies against sars-cov-2, or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer) * pregnant or lactating and breast feeding, or planning on either during the study * unable to comply with planned study procedures and be available for all follow-up visits

Keywords: covid-19
pharmacokinetics of alprazolam sublingual tablet versus conventional tablet

Conditions: Anxiety Disorder

Summary: to assess if the sublingual tablet will have similar pharmacokinetics as the conventional tablet of alprazolam.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. * body mass index (bmi) of 17.5 to 30.5 kg/m2. * signed informed consent. exclusion criteria: * evidence or history of clinically significant abnormalities * positive drug screen, excessive alcohol and tobacco use

Keywords: bioequivalence sublingual alprazolam pharmacokinetics
study comparing blood levels of refacto and advante in hemophilia a

Conditions: Hemophilia A

Summary: the purpose of the study is to compare the pharmacokinetic parameters of refacto and advate, using the chromogenetic substrate assay to measure plasma factor viii activity in plasma.


Eligibility criteria:
inclusion criteria: * severe hemophilia a * previously treated patients with at least 150 exposure days to any factor viii product exclusion criteria: * hypersensitivity to any recombinant factor viii product * history of or current factor viii inhibitor * bleeding episode or other reason requiring factor viii treatment within 3 days of study

Keywords: hemophilia a
an extension study of an investigational drug, lumasiran (aln-go1), in participants with primary hyperoxaluria type 1

Conditions: PH1; Primary Hyperoxaluria; RNAi Therapeutic; siRNA; AGT

Summary: the purpose of this study is to evaluate the long-term safety and tolerability of lumasiran in participants with primary hyperoxaluria type 1.


Eligibility criteria:
inclusion criteria: * enrollment within 12 months of completion of study aln-go1-001 * in the opinion of the investigator tolerated the study drug * if taking vitamin b6 (pyridoxine), willing to remain on a stable regimen for the study duration * women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use a highly effective method of contraception * willing to provide written informed consent and to comply with study requirements exclusion criteria: * clinically significant health concerns (with the exception of ph1) * clinically significant cardiovascular abnormality * abnormal for ast/alt and any other clinical safety laboratory result considered clinically significant * requirement for chronic dialysis

Keywords: hyperoxaluria, primary hyperoxaluria kidney diseases urologic diseases metabolism, inborn errors genetic diseases, inborn metabolic diseases
clinical evaluation of short dentin etching

Conditions: Hypersensitivity Dentin; Dental Restoration Failure of Marginal Integrity

Summary: to evaluate and compare the two-year clinical performance of class i resin composite restorations utilizing a universal adhesive used in different etch-and-rinse strategies (15-second and 5-second etching) and self-etch strategies for bonding.

the experimental design description adhered to the guidelines provided by the consolidated standards of reporting trials (consort) statement. the present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. the trial will follow a split mouth design. a total of thirty adult patients, who are seeking dental treatment, will be enrolled in the study. the participants will be recruited from the operative department clinic at the faculty of dentistry, university of mansoura. the study will focus on ninety class i restorations. no active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. the study is scheduled to be conducted from december 2024 to december 2026. the form and protocol of the study will be approved by mansoura university's ethics committee before initiation. to determine the appropriate sample size, previous studies examining the clinical success rate of posterior class i restorations restored using different adhesive strategies were considered. based on various parameters, including a significance level of 5%, a test power of 80%, and an equivalence limit of 15%, the sample size was calculated. considering a potential dropout rate of 20%, a sample size of 30 subjects (three restorations per patient) was determined to be suitable.

Eligibility criteria:
inclusion criteria: * patients with three primary occlusal caries of upper or lower posterior teeth. * patients must have a good oral hygiene; * patients with tooth gives a positive response to testing with an electric pulp tester * patients with normal and full occlusion, * patients with opposing teeth should be natural with no restorations. exclusion criteria: * high caries risk patients with extremely poor oral hygiene * patients involved in orthodontic treatment or periodontal surgery, * patients with periodontally involved teeth (chronic
patent foramen ovale in cryptogenic stroke study

Conditions: Ischemic Stroke; Patent Foramen Ovale

Summary: the study sought to assess the rate of recurrent stroke and death in stroke patients with a patent foramen ovale randomized to treatment with warfarin or aspirin. this was a multicenter study conducted at 48 u.s. institutions.


Eligibility criteria:
inclusion criteria: * age 30-85 * ischemic stroke within 30 days * glasgow outcome scale ≥ 3 * no contraindications to warfarin/aspirin exclusion criteria: * basal inr \> 1.4 * post-procedural stroke * severe carotid atherosclerosis * cardioembolic stroke * contraindications to transesophageal echocardiography

Keywords: cerebrovascular diseases ischemic stroke patent foramen ovale warfarin aspirin transesophageal echocardiography
ed treatment of suicidal patients with ketamine infusion

Conditions: Suicide; Suicidal Ideation

Summary: this study aims to determine if a single intravenous (iv) dose of ketamine given in the emergency department (ed) can provide a long term reduction in suicidal ideation, lower time to ed discharge, and increase discharge to home or voluntary treatment facilities all while being safe.

suicide has risen to the 2nd leading cause of death in americans aged 10 to 34, and is the10th leading cause of death overall. globally, the world health organization estimates one person dies of suicide every 40 seconds. despite its lethality, no recognized acute treatments for suicidality exist. recently, ketamine, an n-methyl-d-aspartate (nmda) receptor agonist, has been shown to rapidly reduce suicidality in small studies in psychiatric settings. however, most patients with acute suicidal thoughts are treated initially in emergency departments (eds). delays in treatment have both short and long term impacts on recovery as patients spend longer time frames in an actively suicidal state. identifying a rapid and effective treatment for suicidal ideation that can be administered in the ed would have a profound impact on the emergent management of patients with suicidal thoughts. ketamine is an fda approved medication that is commonly used in eds for multiple indications. eds have the familiarity, facilities and personnel to safely administer iv ketamine. ketamine is regularly used in eds in high doses for procedural sedation in adults and children. it is also used in high doses as a sedative for acutely agitated patients. in low-doses ketamine is frequently used for its analgesic properties and is considered safe. ketamine has also been safely used in the pre-hospital setting. in a recent joint policy statement of the american college of emergency physicians recommended the use of low-dose ketamine for pain in control with a safety profile comparable to other intravenous analgesia such as morphine. use of ketamine to rapidly reduce suicidality may facilitate a safe and faster transition of acutely suicidal patients to outpatient treatment. such treatment potentially shortens these patients' ed and hospital lengths of stay.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * chief complaint of suicidal thoughts with a madrs-si score \> 3 * major depressive episode with madrs \> 19 (moderate to severe) exclusion criteria: * pregnancy * psychosis * acute intoxication with alcohol or illicit drugs * acute withdrawal from alcohol or illicit drugs * adults otherwise unable to consent * concurrent, active medical illness requiring medical hospitalization * inability to follow-up including no permanent address or valid telephone number * patients unable to attend outpatient follow-up (no medical insurance, refusal to follow-up, no established care provider) * specific contraindication to the use of ketamine (concern for increased intracranial or intraocular pressure, known allergy to ketamine) * greater than 12 hours from time of ed presentation * prisoners

Keywords: ketamine suicide
a trial comparing the efficacy, patient-reported outcomes and safety of insulin degludec 200 u/ml vs insulin glargine in subjects with type 2 diabetes mellitus requiring high-dose insulin

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in the united states of america (usa). the aim of the trial is to confirm the efficacy of ideg (insulin degludec) versus iglar (insulin glargine) in controlling glycaemia. subjects are to continue their pre-trial metformin treatment.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * current treatment with once daily insulin glargine in vials with a daily dose equal to or above 65 u and equal to or below 100 u * current treatment with a stable dose of metformin plus/minus one additional oral antidiabetic drug (oad) for at least 12 weeks * glycosylated haemoglobin (hba1c) equal to or above 7.5% exclusion criteria: * current treatment with insulin other than insulin glargine in vials * treatment with thiazolidinediones or glucagon-like peptide-1 (glp-1) receptor agonists within 12 weeks * stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty * suffer from cancer (except basal cell skin cancer and squamous-cell cancer)
phase 1/2 study of autologous scg142 tcr t cells in patients with hpv16/52-positive carcinoma

Conditions: HPV-Related Squamous Cell Carcinoma; HPV-Related Cervical Squamous Cell Carcinoma; HPV-Related Vulvar Squamous Cell Carcinoma; HPV-Related Penile Squamous Cell Carcinoma; HPV-Related Vaginal Squamous Cell Carcinoma; HPV-Related Anal Squamous Cell Carcinoma; HPV-Related Head and Neck Cancer

Summary: this is a phase 1/2, open-label, single arm, multicenter study in patients with advanced or metastatic hpv16- or hpv52-positive carcinomas who have progressed after at least one line of systemic therapy, including but not limited to combination chemotherapy and/or combination chemo-immunotherapy

this study will be conducted in 2 parts: the phase 1 part of the trial consists of a dose-escalation portion designed to evaluate the safety and tolerability of scg142, and to identify the rp2d. the phase 2 part of the trial is designed to evaluate the preliminary efficacy of scg142 in the same patient populations.

Eligibility criteria:
main inclusion criteria: 1. histologically confirmed squamous cell carcinoma (scc); may include any of the following tumor types: cervical, head and neck, anal, penile, vulvar, or vaginal. 2. tumor tissue positive for hpv16 or hpv52. 3. advanced or metastatic carcinoma with progression after at least 1 line of standard of care systemic therapies, including but not limited to combination chemotherapy and/or combination chemo-immunotherapy. 4. human leukocyte antigen (hla)-a\*02:01 genotype. 5. measurable disease as defined by recist v1.1. 6. eastern cooperative group (ecog) performance status of 0 or 1. 7. anticipated life expectancy ≥3 months. 8. adequate laboratory parameters including hematologic, renal, hepatic and coagulation function. main exclusion criteria: 1. presence of clinically relevant or active seizure disorder, stroke, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (cns) involvement. 2. active brain metastasis or leptomeningeal metastases. 3. history of other malignancy within 2 years prior to screening. 4. history of organ transplant. 5. positive for human immunodeficiency virus (hiv) or known acquired immunodeficiency syndrome (aids). 6. history of active cardiac disease. 7. history of active pulmonary disease. 8. active, known, or suspected autoimmune disease. 9. lack of peripheral venous or central venous access, or any condition that may prevent trial sample collection and administration of scg142. 10. prior exposure to any cell therapy including, but not limited to natural killer (nk) cells, cytokine-induced killer (cik) cells, dendritic cells (dcs), cytotoxic t lymphocytes (ctls), stem cell therapy, and car/tcr-t cell therapy. 11. allergy to ld chemotherapy (cyclophosphamide or fludarabine) and/or any component of scg142. 12. any serious medical condition or abnormality in clinical laboratory tests.

Keywords: human papilloma virus hpv cervical cancer head and neck cancer oropharyngeal cancer vulvar cancer vaginal cancer penile cancer anal cancer anogenital cancer tcr t cell cell therapy t cell receptor t cell
development and application of a dynamic three-dimensional quantitative facial measurement device

Conditions: Facial Palsy

Summary: the aim of this project is to successfully develop and industrialise the "facial movement 3d dynamic quantitative measurement device", which is a commercial device that can provide dynamic indicators of facial movement, and can practically solve the evaluation problems of facial paralysis for doctors and patients, and has important clinical value and social benefits.

based on the current optimal high-precision face key point technology, the effective high-precision automatic face recognition model conforming to the asian face is established through specialised training with targeted marker data, time series training optimisation based on optical flow, and local image tracking technology. the 3d reconstruction technique is then used to reconstruct the 3d spatial coordinates of the face keypoints, so as to realise the multi-camera 3d tracking of the face keypoints. the displacement of the key points is used to respond to the facial muscle activity characteristics of facial paralysis patients.

Eligibility criteria:
inclusion criteria: 1. older than 14 years 2. no history of facial surgery, facial trauma, or scars obscuring the facial features. 3. able to perform relevant actions according to instructions 4. willingness to participate in the study exclusion criteria: 1. unwillingness to participate in the study 2. unable to co-operate with relevant command actions 3. obvious trauma, scars, etc. obscuring the facial features 4. less than 14 years of age
feasibility study to evaluate deep brain stimulation (dbs) settings for the treatment of parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to assess the cognitive performance in patients with advanced parkinson's disease receiving deep brain stimulation (dbs) with settings predetermined clinically to settings derived from a patient-specific computational model.


Eligibility criteria:
inclusion criteria: * patient is able and willing to provide informed consent to participate in the study. * the patient's implanted dbs system shall be the medtronic, inc. activa® system. the medtronic activa system may consists of either, soletra®, kinetra® activa® rc, or activa® pc neurostimulator(s) and two dbs leads (model 3387 or 3389). * patient shall have bilateral dbs of the subthalamic nucleolus (stn). * patient shall have stable dbs stimulation without changes in stimulation parameters for no less than 3 months prior to enrollment. * patient shall have stable and optimal regimen of antiparkinson drug therapy for no less than 3 months prior to enrollment. * patient, and caregiver if applicable, is able and willing to be available for study visits throughout the duration of the study (e.g. no planned relocation of residence or extended vacation during the study that would prevent compliance with study visit schedule). * availability, from the patient's medical records, of a pre-op mri and high resolution ct with artifact reduction no less than six (6) weeks post-op. * patient shall have hoehn and yahr stage iii or worse when off stimulation and off medication. * patient shall have demonstrated good response to l-dopa, defined as no less than a 30% improvement in a updrs-iii motor exam following the administration of l-dopa during their screening neurological exam. * patient shall have demonstrated good response to dbs following the administration of dbs while off medication, defined as an improvement in updrs-iii motor scores better than their improvement to l-dopa (as determine in above) or no less than 20% worse of an improvement. exclusion criteria: * evidence of secondary or atypical parkinsonism as suggested by: stroke, encephalitis, exposure to toxins, neuroleptic antipsychotics, neurologic signs of upper motor neuron or cerebellar involvement, or supranuclear palsy. * dementia as evidenced by a mini-mental state examination of 24 or below (mmse ≥ 24). * prior participation in the intelect medical guide study.

Keywords: deep brain stimulation dbs parkinson's disease pd patients who have a preexisting deep brain stimulation (dbs) system for the treatment of parkinson's disease (pd)
development and validation of a sputum biomarker mrna panel for the diagnostic work-up of asthma 2

Conditions: Asthma

Summary: the main objectives of the study are: -to unravel the importance of molecular phenotyping in predicting the response to classical anti-asthma treatment (inhaled corticosteroids) the investigators have developed a non-invasive technique based on mrna analysis of induced sputum that enables us to study airway inflammation in detail. this technique forms the basis for our current project based on the following hypotheses: 1. different molecular asthma phenotypes exist: a th2 phenotype and a non th2 phenotype as reported by woodruff and colleagues (woodruff pg et al). sputum mrna cytokine levels can be used to diagnose th2 asthma and discriminate this from non-th2 asthma. 2. based on our previous research and preliminary data that non-th2 asthma can be further divided in th17 asthma and th1+th2 asthma; besides these, a fourth group without th2, th17 or th1 characteristics also exist. the investigators hypothesize that the epithelial cell cytokine, tslp, can be increased as an early marker of airway inflammation in this latter group. 3. these subgroups have different responses to anti-inflammatory treatment.


Eligibility criteria:
inclusion criteria: * steroid naive asthmatics exclusion criteria: * viral/bacterial/fungal infection +fever(\<1month) * asthma exacerbation (\<3months) * other airway diseases (cf, ciliary dyskinesia, bronchiectasis)