Kornimate/medical-research-clean huggingface dataset:
pan-genotypic direct acting antiviral therapy in donor hcv-positive to recipient hcv-negative lung transplant

Conditions: Respiratory Failure; Hepatitis C

Summary: this is a proof of concept, single center study for the donation of hcv-positive lungs to hcv negative recipient patients, with preemptive, interventional treatment with 8 weeks of commercially available daa therapy to prevent hcv transmission upon transplantation.

the goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic daa therapy after lungs transplantation prevents the transmission of hepatitis c virus (hcv) infection from an hcvpositive donor lung to an hcv naïve recipient.

Eligibility criteria:
inclusion criteria: * met mgh transplant center criteria, listed for lung transplant * able to sign informed consent exclusion criteria: * pregnant or nursing (lactating) women * hiv positivity * any contra-indication to lung transplantation per center protocol * for study patients in whom epclusa® therapy is being considered, exclusion criteria includes patients on the following p-glycoprotein inducers or moderate to potent cyp inducers that cannot stop therapy: carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifampin, rifapentine, st. john's wort. * for study patients in whom mavyrettm therapy is being considered, exclusion criteria includes patients on the following medications who cannot stop therapy: carbamazepine, rifampin, st. john's wort, and ethinyl estradiol-containing oral contraceptives.

Keywords: lung disease lung transplant hcv hepatitis c
value of biological age, in addition to individual frailty, for personalising the management of cancer treated with targeted therapy

Conditions: Leukemia,Myeloid, Chronic

Summary: french prospective multicenter, open-label study involving newly diagnosed cml patients. two assessments will be performed during the follow-up of these patients: individual frailty using geriatric tools and individual biological aging determined by dna methylation analysis.


Eligibility criteria:
inclusion criteria: * age ≥18 years * cml in chronic phase at time of diagnosis. diagnosis must be made no more than 3 months (90 days) prior to inclusion. diagnosis of chronic-phase cml (european leukemia network \[eln\] 2020 criteria; baccarani et al 2013) with confirmation of a philadelphia chromosome (ph1). a cryptic ph1 chromosome must be confirmed by fish.criteria must meet the definition of chronic phase cml * bcr ::abl1 transcript quantifiable by quantitative pcr * 1st-line treatment with tyrosine kinase inhibitor * no tyrosine kinase inhibitor or hydroxyurea treatment received prior to first blood sampling (at diagnosis) * signature of informed consent for cml observatory and signature of informed consent for bio-timer protocol * read and understand french * enrolled in a social security plan or beneficiary of such a plan exclusion criteria: * cml in accelerated or blast phase * refusal to participate in the study * treatment started prior to inclusion * patients under guardianship, curatorship, deprivation of liberty or safeguard of justice * pregnant or breast-feeding women
breathing control exercises in patients with chronic obstructive pulmonary disease.

Conditions: Severe Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to test whether breathing control exercises embedded in occupational therapy sessions have an impact on quality of life and dyspnea in patients with chronic obstructive pulmonary disease (copd).

dyspnea is one of the most important and debilitating symptoms in patients with copd and is often the starting point to the vicious cycle of physical inactivity. as a consequence of increased dyspnea, patients adapt themselves by reducing the amount of all activities of daily living performed, with a consequent reduction in quality of life. occupational therapists are involved in pulmonary rehabilitation programs aiming to improve the biopsychosocial condition of copd patients. however, the specific roles and intervention of occupational therapists are not well-defined, and standardized protocols are lacking. the implementation of breathing control exercises in occupational therapy sessions, aiming among other things to regulate patient's breathing during their activities of daily living, could be a starting point for a more effective management of patients with copd. this could ultimately participate in the improvement of quality of life in patients with copd.

Eligibility criteria:
inclusion criteria: * confirmed diagnostic of copd * severity of copd: global initiative for chronic obstructive lung disease (gold) classification iii or iv * undergoing a pulmonary rehabilitation program in j. bracops hospital exclusion criteria: * cardiac or orthopedic complications limiting participation in occupational therapy sessions * active smoking * inability to understand the french language orally or in writing * cognitive impairments limiting understanding of instructions and participation in occupational therapy sessions

Keywords: copd chronic obstructive pulmonary disease occupational therapy breathing control
study on allogeneic osteoblastic cells implantation in rescue interbody fusion

Conditions: Failed Lumbar Fusion

Summary: failed fusion and failure to relieve back pain following spinal fusion are still frequent, irrespective of the type of procedures or grafts used by the surgeon. moreover, revision surgeries are unfortunately associated with higher procedure-related complication rates, technical difficulties, longer operative time, and quite disappointing and unreliable success rates for both fusion and clinical results. the present phase 2a study aims at demonstrating the safety and efficacy of allob®, a proprietary population of allogeneic osteoblastic cells, in rescue interbody fusion.


Eligibility criteria:
inclusion criteria: * ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements * failed lumbar fusion of 15 months minimum requiring a revision surgery at one or two levels between l1 and s1 exclusion criteria: * more than two failed interbody fusions at the involved lumbar level(s) * instrumentation failure requiring revision surgery * local active or latent infection at the involved lumbar level(s) * positive serology for hepatitis b, hepatitis c, hiv * current or past medical disease that could interfere with the evaluation of the safety and efficacy, as judged by the investigator

Keywords: spinal fusion revision surgery pseudarthrosis cell therapy bone graft
study of vsn16r for the treatment of spasticity in multiple sclerosis

Conditions: Spasticity in People With Multiple Sclerosis

Summary: phase ii a proof of concept study in multiple sclerosis (ms) patients with spasticity.

single dose escalation followed by multiple fixed dose administrations to assess short term safety and to determine whether spasticity improves.

Eligibility criteria:
inclusion criteria: * have a confirmed diagnosis of ms * have an expanded disability status scale (edss) ≤ than 6.5 at screening. * spasticity due to ms of at least 3 months duration with minimum mean score of \>/=2 mash exclusion criteria: * acute ms relapse requiring treatment with steroids within 30 days of screening. * initiation or discontinuation of ms disease modifying treatment (dmt) within 30 days of screening. * receiving medications that would potentially interfere with the actions of the study medication or outcome variables * significant renal and hepatic abnormalities * previous history of other significant medical disorders

Keywords: ms spasticity vsn16r
study of mental fatigue in polio survivors

Conditions: Post-Poliomyelitis Syndrome

Summary: post-poliomyelitis syndrome (pps) is the term describing the new problems affecting polio survivors many years after recovery from paralytic polio. among the symptoms, fatigue is one of the most frequent and debilitating. in addition to physical incapacitation, the fatigue of pps also affects mental function. the term "brain fatigue" is usually used by patients to express problems on the areas of attention, concentration, memory and clear thinking. unfortunately, little is known about cognitive fatigue of pps patients. this study is meant to examine if mental impairment is present in pps patients and, if so, how it interferes on the self-function of patients. patients will undergo an interview, clinical and neurological evaluation, and a battery of screening laboratory tests to make sure they are eligible for the study. patients who qualify will undergo neuropsychometric tests in order to assay performance in the main areas of cognitive functioning. through this organized approach we expect to be able to determine if mental fatigue is a significant problem affecting polio survivors, what areas are most affected, and how it may interfere with daily living.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * be a survivor of poliomyelitis * willing to attend two clinic visits for completion of screening procedures and required tests exclusion criteria: * suffer from medical conditions that can interfere with cognitive function, including stroke, traumatic brain injury, dementia (progressive memory loss), severe depression, psychosis or other psychiatric disorders, etc.

Keywords: candidates for this study are survivors of paralytic poliomyelitis
efficacy study of vitamin d and statins to treat hypercholesterolemia

Conditions: Primary Hypercholesterolemia

Summary: the investigators planned to research the effect of vitamin d supplementation as an adjuvant therapy for patients with hypercholesterolemia.

vitamin d is primarily generated in the skin, in response to direct absorption of ultraviolet b radiation. vitamin d can also be obtained through fortified foods and oral supplements. lipid abnormalities are common in the general population, and are regarded as a modifiable risk factor for cardiovascular disease. recently low vitamin d status has been shown to be associated with increased risk of developing hyperlipidemia. statins are normally the first-line therapy for hypercholesterolemia. it is also reported that vitamin d can improve serum lipid levels. however, its effects on hypercholesterolemia patients remain unclear. the investigators planned to determine the efficacy of combination therapy with statins and vitamin d in a cohort of hypercholesterolemia patients. this study may shed light as to whether oral vitamin d supplementation can be an adjunct therapy in hypercholesterolemia patients.

Eligibility criteria:
inclusion criteria: the main inclusion criteria were for hypercholesterolemia patients with the treatment of statins. exclusion criteria: the exclusion criteria were as follows: patients with chronic renal failure, chronic liver disease, bone disorders, and/or thyroid disorders. patients were also excluded if they were taking vitamin d3 tablets or other lipid-regulating drugs.

Keywords: hypercholesterolemia; vitamin d; adjuvant therapy
nebulized morphine in chest trauma patients: a prospective study

Conditions: Blunt Injury of Thorax

Summary: this is a prospective study carried out from 2018 to 2020 including patients aged ≥ 18 years, admitted for isolated chest trauma. each patient received a nebulization of 10 mg morphine. if visual analog score (vas) assessed after 10 minutes still\> 4, nebulization was repeated every 10 minutes until pain relief. at 30 minutes, vas\> 4 means failure.

the aim of this study was to determine the predictive factors of nebulized morphine failure in patients with chest trauma and to establish a score based on these factors to guide the analgesic protocol. methods: this is a prospective study carried out from 2018 to 2020 including patients aged ≥ 18 years, admitted for isolated chest trauma. each patient received a nebulization of 10 mg morphine. if visual analog score (vas) assessed after 10 minutes still\> 4, nebulization was repeated every 10 minutes until pain relief. at 30 minutes, vas\> 4 means failure.

Eligibility criteria:
inclusion criteria: * patients aged 18 years and over * victims of isolated chest trauma, * admitted to the intensive care unit exclusion criteria: * not consen * pregnant woman * polytrauma * hemodynamic instability with systolic blood pressure less than 100 mmhg, * treated with morphine during transport or in the emergency room * need initial ventilatory support, bradypnea (respiratory rate less than 12 cycles per minute) * allergy to opiods * initial pain visual analog scale (vas) ≤ 4
evaluation of the effects of oxygen therapy and enalapril for diabetic macular ischemia

Conditions: Diabetic Macular Ischemia

Summary: in this study, patients were divided into 3 group with 35 cases including: 1.oxygen 2.enalapril 3.control. in the beginning of the study, best corrected visual acuity (bcva), uncorrected visual acuity (ucva), and optical coherence tomography (oct) were measured. patients in the oxygen group were given oxygen 10 lit/min 1 hour twice a day at the first month, once a day at the second month and every other day at the third month. in the enalapril group, patients were given enalapril 5 mg every night and placebo was given for the patients in third group. at the end of first month the patients' vision was checked again and at the the end of the third month the first physical examinations were performed. in the first group, arterial blood gas (abg) was taken before and after oxygen therapy as well.


Eligibility criteria:
inclusion criteria: * patients diagnosed with diabetic macular ischemia exclusion criteria: * htn \> 1140/90 or htn controlled by ace inhibitors * fbs \> 200 * severe anemia, copd, cataract, hrpdr and diffuse macular edema
the effect of eyeliner on tear composition, tear secretion and tear film stability.

Conditions: Dry Eye

Summary: eyeliner is one of the most common eye cosmetics. the main ingredients are titanium oxide, pigment, grease and preservative. the user will apply the eyeliner to the eyelid and eyelash. with the blinking again and again, the components of the eyeliner may enter the tear film and continue to act on the eye surface. therefore, the investigators suspect that the use of eyeliner may be an important factor leading to dry eye disease. in order to explore the relationship between the use of eyeliner and dry eye disease, the investigators plan to collect eye surface characteristic data of the two groups of people who use eyeliner and who do not use it.then use raman analysis to explore whether the use of eyeliner will lead to changes in tear composition.the investigators intend to analyze the difference of tear composition between the two groups to understand the relationship between the change of tear composition and tear film stability.so that the investigators can identify the risk factors of dry eye disease, and provide basis for prevention and early treatment.

the investigators will include the population according to the inclusion criteria and exclusion criteria.the subjects in the eyeliner group and the control group filled in the survey to score the ocular surface disease index. tear secretion test and sodium fluorescein staining are conducted in the eyeliner group and the control group, and the results are recorded. the intraocular pressure of the two groups is measured and recorded. dry eye analysis is conducted for the two groups of people to collect relevant data. tears are collected by capillary glass tube and stored for further raman analysis.

Eligibility criteria:
inclusion criteria: * people aged 20-35 who use eyeliner or do not use eyeliner . * people who use eyeliner have used it for ≥ 1 year; frequency ≥ 3 times/week. exclusion criteria: * other serious systemic diseases. * other systemic diseases related to ocular surface, such as rheumatoid arthritis, systemic lupus erythematosus, sjogren's syndrome and other immune system diseases or other eye diseases, history of eye surgery and trauma. * lactating women or pregnant women. * use electronic products for more than 4 hours every day. * patients with circadian rhythm disorder. * people with radiation exposure history. * non permanent residents in wuhan.
monitoring stomach function with an intragastric balloon - a pilot

Conditions: Functional Disorders of Stomach

Summary: in this pilot study the investigators test the hypothesis that gastric motility can be measured with an intragastric balloon.


Eligibility criteria:
inclusion criteria: * they are between 18-60 years old. * male and female. * patients must provide witnessed written informed consent prior to any study procedures being performed. exclusion criteria: * they are older than 60 years old. * have severely decreased kidney function. * have severely decreased liver function. * have severe heart disease, for example a history of irregular heartbeats, angina or heart attack. * have severe lung disease. * have severe psychiatric illness or neurological illness. * have any gastrointestinal disease. * have any dyspeptic symptoms. * women that are pregnant or breastfeeding.
long-term safety and efficacy study of lb80380 in the treatment-naive patients of chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: the purpose of the study is to investigate the long-term safety and the antiviral activity of the optimal doses of lb80380 for additional 48 weeks in treatment-naive patients with chronic hepatitis b infection compared to entecavir 0.5 mg.

lb80380, an oral prodrug, is a promising candidate nucleotide analogue with antiviral activity against wild-type hepatitis b virus (hbv). lb80380 is undergoing clinical development by lg life sciences for use in the treatment of chronic hbv infection. this study is an extension study of the phase iib (protocol no. lg-bvcl007), the treatment period of this study is 48-week with 24-week of follow-up period

Eligibility criteria:
inclusion criteria: * the patients who are able to participate in this expanded study without any interruption after completing 48 weeks treatment of lg-bvcl007 study exclusion criteria: * co-infection with hepatitis c or d virus (hcv or hdv) or hiv * decompensated liver disease * alt \> 10 x uln * creatinine clearance (calculated by cockcroft-gault formula) less than 50 ml/min * alpha-fetoprotein (afp) value greater than or equal to 50 ng/ml, and a follow-up ultrasonography performed prior to baseline shows findings indicative of hcc * treatment with immunomodulatory agent or corticosteroids within 6 months prior to study entry. * pregnancy or breast-feeding * patient is currently abusing alcohol or illicit drugs * significant systemic illnesses other than liver diseases * presence of other causes of liver disease * plan for liver transplantation

Keywords: chronic hepatitis b lb80380 treatment-naive entecavir extension
a phase 2 study to evaluate the safety and efficacy of ctp-692 as an adjunctive treatment in adults with schizophrenia

Conditions: Schizophrenia

Summary: the objective of this study is to assess the safety and efficacy of 3 different doses of ctp-692 administered once daily (qd) for 12 weeks to adult participants with schizophrenia on stable dopaminergic antipsychotic medication.


Eligibility criteria:
inclusion criteria: * physician confirmed diagnostic and statistical manual-version 5 (dsm-v5) diagnosis of schizophrenia for the past 2 years * patients with clinically stable schizophrenia with residual symptoms defined as positive and negative syndrome scale (panss) total score of 70-110 * patients currently treated with one antipsychotic medication exclusion criteria: * patients who, in the opinion of the investigator, have a history of antipsychotic treatment resistance * patients currently taking clozapine * history of meeting dsm-v5 criteria for moderate to severe alcohol or substance use disorder (other than nicotine or caffeine) within the 6 months before the first screening visit * patients with positive blood screen for human immunodeficiency virus (hiv) antibody and/or hepatitis b virus surface antigen * patients with history of renal disease or those taking medications to treat renal disease
validating cgm for gdm

Conditions: Gestational Diabetes Mellitus (GDM)

Summary: this is a prospective pilot study to assess the validity of using a continuous glucose monitor (cgm) in diagnosing gestational diabetes mellitus (gdm). pregnant individuals between the ages of 18-50 years old receiving prenatal care at mount sinai hospital (e..g, e-level clinic and faculty practice associates) will be enrolled. potential participants will be approached during their prenatal care appointments. participants will complete an informed consent form for the study during their standard-of-care prenatal appointments at our institution.


Eligibility criteria:
inclusion criteria: * ages 18-50 * singleton pregnancy between 24-32 weeks gestational age * prenatal care and delivery at mount sinai hospital exclusion criteria: * multiple fetal gestation * preexisting diabetes * concurrent use of steroids * anomalous fetus * insufficient prenatal care (identified as missing half the recommended visits or establishing care after 20 weeks gestation) * unable to tolerate oral glucose test
diabetes peripheral neuropathy and small-fibre nerve damage: a comparative study

Conditions: Diabetes Mellitus; Peripheral Neuropathy; Small Fibre Neuropathy; Autonomic Neuropathy

Summary: the purpose of this study is to investigate whether patients with diabetes-related peripheral neuropathic pain also have non-recognized damage to the intestine caused by autonomic neuropathy. the model will shed light on aspects of peripheral nerve injuries on both somatic and as well as visceral sensory nerves. classical autonomic parameters from electrocardiography (ecg) and holter (24-h ecg and blood pressure) are compared with peripheral nerve injuries. the damage of autonomic nerves often recognized late in the course when patients develop gastroparesis, however an earlier recognition of this nerve damage may help clarifying the fundamental pathomechanisms and thereby optimize treatment for this patient group in the future.


Eligibility criteria:
inclusion criteria: 1. male or female patients between 18 and 75 years with diagnosed diabetes mellitus, according to who criteria (world health organization). 2. proven peripheral neuropathy. 3. oral and written consent, with documentation that all relevant information about the program is given to the patient. 4. the patient must be willing and able to, to meet the planned visit and meet the planned curriculum, including the participation in the experimental investigations. exclusion criteria: 1. pregnancy or breastfeeding 2. medical or surgical disease for the study doctor's assessment makes the patient unsuitable for participation in the study 3. previous or ongoing major depression 4. patients who can or will not comply with the recommended instructions given by the study doctor 5. use of analgesic opioid medication less than 24 hours before screening 6. competitive conditions that can cause peripheral neuropathy (eg, herpes zooster) 7. clinically significant disease less than 2 weeks from the planned entry in the study 8. people involved in the planning or execution of the study