Kornimate/medical-research-clean huggingface dataset:
emergent expanded access for ahsc augmentation of nerve autografts after severe peripheral nerve injury.

Conditions: Sciatic Nerve Injury

Summary: the primary purpose of this research study is to determine the safety of injecting ones own schwann cells to augment sural nerve autografts after a severe, non-lacerating injury to the sciatic nerve has occurred.

the secondary purpose of this research project is to evaluate whether transplanted schwann cells can enhance recovery of sensory and motor function. emergency expanded access for a single patient was granted, as the patient was an ideal candidate for sural nerve repair augmented by autologous schwann cells which could be harvested from a relatively small segment of sensory nerve. the cells were expanded using cell culture techniques and placed along with the sural nerve grafts wrapped by an fda approved collagen matrix (duragen). this study is being conducted at the jackson memorial and the university of miami health systems. as a research subject the patient will be in this study for a total of 5 years from the date receiving schwann cell transplant augmentation of sural nerve autografts.

Eligibility criteria:
single patient with severe sciatic nerve injury enrolled under emergency request
perception of affordances and obstacle crossing in people with parkinson's disease and healthy adults

Conditions: Parkinson&#39;s Disease (PD)

Summary: this study aims to explore how young adults, older adults and people with parkinson's disease (pwp), perceive their abilty to cross obstacles while walking, and how this perception is related to their actual performance of obstacle crossing and disease-related motor and cognitive impairments. the study will explore this percepeption and the actual performance in different walking environments(floor, synthetic grass turf). understanding how people perceive obstacles may help improve rehabilitation methods and reduce the risk of falls. the study will take place at the motor performance laboratory, university of haifa, and will include walking tasks, eye-tracking measurements, and motor and cognitive assessments.

this study investigates the role of affordance perception - the ability to perceive opportunities for action - during obstacle crossing in people with parkinson's disease (pwp). falls are highly prevalent in pwp, often resulting from tripping over obstacles. while previous research has mainly focused on gait impairments, this study uniquely examines the perceptual stage that precedes movement and the association between perception, cognition, and motor performance. participants will include 60 pwp and 120 healthy adults (60 older adults and 60 young adults). all participants will perform walking tasks involving obstacle crossing under different environmental conditions (e.g., different obstacle heights and surfaces). prior to walking, participants will judge whether they can safely cross the obstacle. eye-tracking glasses will measure visual exploration patterns to assess how participants scan the environment. additionally, walking variables such as speed and step length, will be recorded using wearable sensors. the study will explore: 1. differences in affordance perception between pwp and healthy adults. 2. associations between motor and cognitive impairments and affordance perception in pwp. 3. how affordance perception relates to gait performance during obstacle crossing. results from this study may help to develop new intervention strategies aimed at improving safe walking and obstacle negotiation in pwp.

Eligibility criteria:
inclusion criteria: * participants aged 20 to 80 years. * ability to walk independently outdoors without assistive devices. * for parkinson's disease (pd) group: diagnosis of pd confirmed by medical records. * for healthy control groups: no neurological or orthopedic conditions affecting gait. exclusion criteria: * feezing of gait (for pd group only), based on a score greater than 0 on the freezing of gait questionnaire. * severe visual impairment that cannot be corrected with glasses or lenses. * cognitive impairment, defined as a score below 18 on the telephone-based mini-mental state examination (mmse). * any orthopedic condition, pain, or other medical condition that may affect walking, based on self-report.

Keywords: parkinson&#39;s disease obstacle crossing gait affordances motor control balance fall risk visual exploration gaze behavior
determining the effects of risperdal consta in patients with psychotic disorders and incomplete adherence

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: as many as 75 percent of patients with schizophrenia have difficulty taking their oral medication on a regular basis. this may lead to worsening of symptoms. clinicians commonly respond to these problems by adding adjunctive medications, despite the absence of systematic studies that support such practices. it is possible, however, that in many of these cases, the unstable course and/or unsatisfactory treatment response reflects incomplete adherence with the originally prescribed oral antipsychotic, rather than a need for adjunctive medications. this study will examine whether switching patients who demonstrate an unstable course and/or an unsatisfactory clinical response to a long-acting injectable preparation as the primary antipsychotic may enhance medication adherence and improve outcomes.


Eligibility criteria:
inclusion criteria: * eligible patients will be male or female * between 18-65 years of age and will meet dsm-iv criteria for schizophrenia or schizoaffective disorder. * the subject must have, in their physicians opinion, an unstable course and must have been treated with an oral antipsychotic. exclusion criteria: * pregnant and breast feeding females will be excluded. * because fluoxetine is known to change the plasma level of consta, subjects taking fluoxetine within two weeks of starting the study will be excluded. * patients who are known to have a hypersensitivity to oral risperdal will be excluded.
omega-3 fatty acid in reducing cancer-related fatigue in breast cancer survivors

Conditions: Breast Carcinoma; Cancer; Fatigue

Summary: this randomized pilot clinical trial studies omega-3 fatty acid in reducing cancer-related fatigue in breast cancer survivors. supplementation with omega-3 fatty acid may help reduce cancer-related fatigue in breast cancer survivors.

primary objective: i. to collect preliminary statistical data (mean changes and standard deviations) on two omega-3 supplementation (omega-3 fatty acid) regimens (1.65 g/day and 3.3 g/day) compared to placebo for reducing cancer-related fatigue (crf) in fatigued breast cancer survivors. outline: patients are randomized to 1 of 3 arms. arm i: patients receive low-dose omega-3 fatty acid supplementation orally (po) twice daily (bid) and placebo po bid for 6 weeks. arm ii: patients receive high-dose omega-3 fatty acid supplementation po bid for 6 weeks. arm iii: patients receive placebo po bid for 6 weeks.

Eligibility criteria:
inclusion criteria: * have a confirmed diagnosis of breast cancer; participants can have had more than one primary cancer diagnosis in the past * have undergone some type or combination of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer * have completed all forms of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer between 4 and 36 months prior to enrollment in the study; participants can be currently taking hormones (such as tamoxifen) or monoclonal antibodies (such as herceptin) * must have cancer-related fatigue, as indicated by a response of 4 or greater when asked to rate their level of fatigue at its worst in the past week on an 11-point scale anchored by "0" = no fatigue and "10" = as bad as you can imagine * be able to read english * able to swallow medication * give written informed consent exclusion criteria: * have used marine omega-3 supplements at any time within previous 3 months (this includes prescription omega-3 drugs such as lovaza®) * be taking anticoagulant medication (does not include aspirin) * have sensitivity or allergy to fish and/or shellfish * have sensitivity or allergy to soy and/or soybeans * have confirmed diagnosis of chronic fatigue syndrome or other diagnosis known to cause severe fatigue

Keywords: cancer survivor
genetic profiling of liver cancer in patients undergoing liver transplantation

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to determine whether genetic markers unique to liver cancer are present and to assess usefulness as a diagnostic tool.

hepatocellular carcinoma (hcc) is the most common form of liver cancer and a growing trend worldwide. decision-making regarding treatment for patients is limited by the lack of clinically actionable biomarkers. this is pronounced in the case for determining and monitoring liver transplant recipients. in an effort to improve diagnosis, the use of circulating serum-based microrna isoforms (isomirs) can serve as non-invasive, screening biomarkers in hcc patients pre- and post-transplantation of the liver.

Eligibility criteria:
inclusion criteria: * patients with the diagnosis of hcc who are on the wait list for liver transplantation * patients with the diagnosis of hcc who have been admitted to hospital, scheduled to undergo liver transplantation within the following 24 hours. * age range: 18 to 75 years old exclusion criteria: * patients with metastatic hcc and patients with the diagnosis of hcc who are not on the wait list for liver transplantation. * patients older than 75 years old and younger than 18 years old. * patients who are unable to consent. * pregnant patients.

Keywords: hcc liver cancer
acute exposure of simulated hypoxia on heart rate and ventilation during exercise

Conditions: Pulmonary Hypertension

Summary: randomized crossover trial in patients with pulmonary hypertension (pah, cteph) to assess the acute response to simulated altitude (fio2: 15.1% = equivalent to 2500m above sea level) on heart rate and ventilation changes under exercise.

low altitude baseline measurements will be performed in zurich (469m asl) including echocardiography, right heart catheterization, six-minute walk test (6mwt), pulmonary function test, clinical assessment and blood gas analysis at rest and under exercise. randomly assigned to the order of testing, the participants will be tested under simulated altitude (fio2: 15.1% with the "amc altitrainer") and shamed altitude with the same device. during the exposure to simulated altitude (fio2: 15.1%) and shamed altitude of 1 hour each, the participants' heart rate and ventilation will be compared under exercise.

Eligibility criteria:
inclusion criteria: * informed consent * ph diagnosed according to internation guidelines: mean pulmonary artery pressure (mpap) ≥ 25 mmhg along with a pulmonary artery wedge pressure (pawp) ≤15 mmhg during right heart catheterization at the time of initial diagnosis * ph class 1 (pah) or 4 (cteph) * stable condition, on the same medication for \> 4 weeks * patient live permanently at an altitude \< 1000m asl. exclusion criteria: * resting partial oxygen pressure (pao2) ≤7.3 kilopascal (kpa) corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed) * severe daytime hypercapnia (pco2 \> 6.5 kpa) * susceptibility to high altitude related diseases (ams, high-altitude pulmonary edema (hape), etc.) based on previous experienced discomfort at altitudes. * exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation * residence \> 1000m above sea level * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability * women who are pregnant or breast feeding

Keywords: simulated altitude exercise ventilation heart rate
familial clustering of vitamin d deficiency via shared environment: the korean national health and nutrition examination survey 2008-2012

Conditions: Vitamin D Deficiency

Summary: vitamin d deficiency is a modifiable risk factor for poor bone health. familial correlation of serum 25-hydroxyvitamin d concentration (25(oh)d) was reported in twin- or family-based studies, mostly from caucasian parent-offspring pairs. however, data on the familial association of 25(oh)d in extended family structure and the relative contribution of genetic and shared environmental factors on serum 25(oh)d level are limited in asian populations. in this study, the investigators aimed to assess the relative contribution of additive genetic and environmental components on serum 25(oh)d level by variance components method in a nationwide family-based cohort. further, the investigators will evaluate the association of vitamin d status of index individual with prevalent vitamin d deficiency of each family member including spouse, offspring, sibling, and grand-offspring. additive influences of paternal and maternal vitamin d status on offspring will be also investigated.

from the korean national health and nutritional examination survey (knhanes) conducted between 2008 and 2012, familial correlations for 25(oh)d will be estimated in different types of family relation pairs in 28551 subjects from 10882 families. the relative contribution of additive genetic and shared or individual environmental factors for variance of 25(oh)d level will be calculated using variance component method. interactions between paternal and maternal vitamin d status for 25(oh)d level of offspring will be evaluated.

Eligibility criteria:
inclusion criteria: * knhanes(korean national health and nutrition examination survey) 2008-2012 participants exclusion criteria: * missing value on 25-hydroxyvitamin d levels * data on another household member was unavailable * the precise family relationship between the subjects was unclear
pilot trial: postoperative opioid-free analgesia

Conditions: Outpatient Surgery; Abdominal Surgery; Breast Surgery

Summary: north america is facing an opioid epidemic fueled by surgeons, who are the second largest subgroup of physicians involved in opioid prescribing. surgery often serves as the initial event for opioid-naïve patients to obtain a prescription for opioids and spiral into misuse and addiction. from the perspective of perioperative care clinicians, the answer to the opioid crisis may be using opioid-free analgesia. however, the number of comparative studies in this field is limited and existing small trials do not reflect current standards of care in north america. lack of evidence means that the decision to prescribe opioids after outpatient surgery largely depends on surgeon preference and healthcare culture. hence, there is an urgent need for a robust randomized controlled trial (rct) to guide clinical decision-making. the feasibility and optimal design of this rct should be informed by a pilot trial. the overarching goal of this pilot rct is to investigate the feasibility of conducting a full-scale rct to assess the comparative-effectiveness of opioid versus opioid-free analgesia after outpatient general surgery.

this study will be a pragmatic, parallel, two-group, assessor-blind, pilot rct. the investigators aim to recruit 80 adult patients at two tertiary hospitals in montreal. eligibility criteria will span outpatient procedures in abdominal and breast surgery. patients are randomized on a 1:1 ratio to treatment with either opioid (standard care) or without opioid (only non-opioid analgesics). patients will be followed up for 3 months after surgery; postoperative day (pod) 1 to pod 7 and at 2, 3 and 4 weeks after surgery, and at 3 months. assessments will include postoperative pain, physical and mental function, adverse drug events, prolonged opioid use and opioid misuse. feasibility outcomes will include the number of patients screened, consented and randomized, adherence with treatment and completion of follow-up. data from this pilot study will inform the calculation of sample size requirements for the full-scale rct. an embedded qualitative study will be conducted to help optimize trial design based on clinicians' and patients' perspective.

Eligibility criteria:
inclusion criteria: adult patients (\>18 yo) undergoing outpatient surgery * abdominal surgery (i.e. cholecystectomies, hernia repairs, ovarian cystectomies, salpingectomies) * breast surgery (i.e. lumpectomies, partial and complete mastectomies, axillary node dissections) exclusion criteria: all patients * intraoperative or early postoperative complications (i.e. diagnosed in the post-anesthesia care unit (pacu)) that require postoperative hospital stay * contraindications to any of the drugs used in the trial * difficult to be reached after surgery * inability to provide written informed consent

Keywords: opioids surgery postoperative period postoperative pain analgesia pain management
single ascending dose study in participants with lca10

Conditions: Leber Congenital Amaurosis 10; Inherited Retinal Dystrophies; Eye Diseases, Hereditary; Retinal Disease; Retinal Degeneration; Vision Disorders; Eye Disorders Congenital

Summary: the purpose of this study is to evaluate the safety, tolerability and efficacy of a single escalating doses of edit-101 administered via subretinal injection in participants with lca10 caused by a homozygous or compound heterozygous mutation involving c.2991+1655a\>g in intron 26 of the cep290 gene ("lca10-ivs26").

this is an open-label, single ascending dose study of edit-101 in adult and pediatric (ie, ages 3 to 17) participants with lca10-ivs26. up to 34 participants will be enrolled in up to 5 cohorts to evaluate up to 3 dose levels of edit-101 in this study. edit-101 is a novel gene editing product designed to eliminate the mutation on the cep290 gene that results in the retinal degeneration that defines lca10-ivs26.

Eligibility criteria:
inclusion criteria: * male or female * at least 3 years of age at screening with cep290-related retinal degeneration caused by a homozygous or compound heterozygous mutation involving c.2991+1655a\>g in ivs26 of the cep290 gene. * visual acuity: * sentinel participant will have severe vision loss with a logmar bcva of ≥1.6 to 3.9 (20/800 or worse to lp) in the study eye * non-sentinel participants must have bcva between 1.0 - 3.0 logmar in the study eye exclusion criteria: * other known disease-causing mutations * achieves a passing score for the mobility course at the most difficult level * in either eye, active systemic or ocular/intraocular infection or inflammation * in either eye, history of steroid-responsive intraocular pressure with increases \> 25 mm hg following corticosteroid exposure * any vaccination/immunization in the last 28 days before screening * inability or unwillingness to take oral prednisone * prior gene therapy or oligonucleotide treatment

Keywords: cep290 lca10 retinal degenerative diseases (rdd) leber congenital amaurosis (lca) congenital retinal blindness p.cys998x c.2991+1655a>g crispr treatment cas9 protein eye diseases signs and symptoms genetic diseases, inborn congenital abnormalities eye abnormalities crispr-cas9 crispr associated protein 9 cas9 enzyme
the correlation of clinical and ultrasonographic findings in dorsoradial wrist pain patients: cross sectional study

Conditions: Carpometacarpal (CMC) Joint Arthritis; Ganglion Cyst; De Quervain Disease; Radial Neuropathy

Summary: this study aims to investigate the correlation between ultrasonographic and clinical findings in dorsoradial wrist pain. there are several etiologies for dorsoradial wrist pain, including carpometacarpal joint arthritis, de quervain's tenosynovitis, proximal and distal intersection syndrome, wartenberg syndrome, and ganglion cysts. in these clinical scenarios, certain physical examination tests are utilized, such as the finkelstein test for de quervain's tenosynovitis; however, this test may also yield positive results in cases of severe joint arthritis. ultrasonography is proposed as a complementary tool for differential diagnosis. the investigators aim to examine the correlation between clinical test results and ultrasonographic parameters such as tendon thickness in the first extensor compartment, carpometacarpal joint synovitis, cortical irregularities, and the presence of osteophytes. functional status will be assessed using the quickdash and fihoa questionnaires.

in the assessment of the first carpometacarpal (cmc) joint, the following ultrasonographic parameters will be evaluated: synovitis, presence of osteophytes, joint surface irregularity, and doppler signal activity. additionally, conventional hand radiographs of all participants will be reviewed to support the imaging findings. for the evaluation of de quervain's tenosynovitis, tendon sheath thickness, tendon cross-sectional area, and intratendinous doppler activity will be measured. at the anatomical intersection zones of the first dorsal compartment, the presence of peritendinous fluid and associated doppler activity will also be assessed to identify potential sites of friction or inflammation. assessment of the superficial radial nerve will include measurement of its cross-sectional area. a cross-sectional area exceeding one square millimeter will be considered indicative of possible neuropathy.

Eligibility criteria:
inclusion criteria: * pain in dorsoradial wrist exclusion criteria: * known rheumatological disease * history of forearm, wrist, hand fracture * history of forearm, wrist, hand operation * mental retardation * history of major trauma in forearm, wrist and hand * fibromyalgia

Keywords: carpometacarpal joint arthritis ultrasonography dorsoradial wrist pain de quervain disease intersection syndrome ganglion cyst
confirmatory study of opc-12759 ophthalmic suspension

Conditions: Dry Eye Syndromes

Summary: the purpose of this study is to verify whether opc-12759 ophthalmic suspension is effective compared with active control in dry eye patients.


Eligibility criteria:
inclusion criteria: 1. out patient 2. subjective complaint of dry eye that has been present for minimum 20 months 3. ocular discomfort severity is moderate to severe 4. corneal - conjunctival damage is moderate to severe 5. unanesthetized schirmer's test score of 5mm/5minutes or less 6. best corrected visual acuity of 0.2 or better in both eyes exclusion criteria: 1. presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca 2. ocular hypertension patient or glaucoma patient with ophthalmic solution 3. anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study 4. anticipated use of contact lens during the study 5. patient with punctal plug 6. any history of ocular surgery within 12 months 7. female patients who are pregnant,possibly pregnant or breast feeding 8. known hypersensitivity to any component of the study drug or procedural medications 9. receipt of any investigational product within 4 months.