Kornimate/medical-research-clean huggingface dataset:
safety, immunogenicity, and immune persistence study of an inactivated hepatitis a vaccine

Conditions: Hepatitis A

Summary: a double-blind, randomized and controlled clinical trial was conducted in healthy children aged from 1 to 8 years to evaluate the immunogenicity and safety of three consecutive lots of a preservative-free inactivated hepatitis a vaccine (healive®). participants who completed their primary vaccination were invited to participate in the follow-up phase. written informed consents were obtained from them. the follow-up study was open-label. these subjects were visited in the next 11 years for blood sampling and assessment of immune persistence induced by vaccination.

the investigated vaccine is an inactivated, adjuvanted and preservative-free hepatitis a vaccine. each dose contained 250 u hav antigen in 0.5 milliliter. total 400 subjects were enrolled and assigned into four groups, each receiving one of the three lots of healive® or an established control vaccine at month 0 and 6. anti-hav titers were determined at month 1, 6 and 7. anti-hav titer over 20 miu/ml is defined as seroprotection. after the full immunization schedule, written informed consents were obtained from subjects who would like to participate in the follow-up study. blood samples of these subjects were collected at month 18, 30, 42, 54, 66, 112,138 after the first injection to evaluate the seroconversion rates (scrs) and geometric mean concentrations (gmcs) of antibody against hepatitis a virus. serological results of the follow-up study were then used to explore suitable statistical model for predicting the persistence of hepatitis a vaccine-induced antibodies.

Eligibility criteria:
inclusion criteria: * health children from 1 to 10 years * not participate in any other trial during the course of the trial * informed consent exclusion criteria: * any history of allergic reactions or convulsions following vaccination * other known or planned vaccination within 1 month prior to the study and during the study period * any chronic illness/disease including virus hepatitis, tuberculosis and epilepsy * presence of any congenital abnormality, upgrowth obstacle * any history/suspicion/presence of neurology and lunacy * any current or foreseeable use of immunosuppressors (i.e. corticosteroids , immunoglobulins) within 1 month prior to the vaccination and during the period of the study * contraindication to intramuscularly injection due to thrombocytopenia or other bleeding disorders * abnormal alt * positive markers for anti-hav and hbv（hbsag）infection * presence of fever at the time of vaccination, i.e. body temperature (by mouth) \> 37.0 centigrade.

Keywords: inactivated hepatitis a vaccine healive safety immunogenicity immune persistence
montreal cognitive assessment index following mri guided focused ultrasound thalamotomy

Conditions: Essential Tremor

Summary: we assessed montreal cognitive assessment scores before and after mri guided focused ultrasound thalamotomy for tremor in order to identify if there are changes in cognitive function following treatment.

all patients who underwent mri guided focused ultrasound thalamotomy underwent cognitive assessment by montreal cognitive assessment. we calculated the scores before and after treatment and compared the results.

Eligibility criteria:
inclusion criteria: * patients that underwent mri guided focused ultrasound thalamotomy and suffered from essential tremor. exclusion criteria: * patients that did not undergo mri guided focused ultrasound thalamotomy * patinets that did not suffer from essential tremor. * patients that underwent mri guided focused ultrasound for areas other then a thalamus * patients tat underwent bilateral thalamothomy
trial of xp (capecitabine/cddp) simvastatin in advanced gastric cancer patients

Conditions: Gastric Cancer

Summary: based on antitumor activity of statin, we designed a phase iii study of capecitabine/cddp chemotherapy plus a low-dose simvastatin that is equivalent to cardiovascular dose in advanced gastric cancer patients.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenoca (i.e. an adenocarcinoma with \> 50% extension in the stomach) 2. patients must present with stage iv disease not amenable to surgery, radiation or combined modality therapy with curative intent. patients previously undergoing local treatment (surgery and/or radiation) must have subsequently progressed or recurred 3. measurable or evaluable disease according to recist 4. age, 18 years or older 5. ecog performance status 0 - 2 6. adequate organ function as defined by the following criteria absolute neutrophil count (anc) ≥ 1,500/ul platelets ≥ 100,000/ul ast/alt ≤ 2.5 x uln, ≤ 5.0 x uln if liver involvement total serum bilirubin ≤ 3.0 mg/dl 7. signed written informed consent exclusion criteria: 1. severe co-morbid illness and/or active infections 2. pregnant or lactating women 3. active cns metastases not controllable with radiotherapy or corticosteroids 4. active and uncontrollable bleeding from gastrointestinal tract 5. known history of hypersensitivity to study drugs 6. patients who are already on statin treatment for hyperlipidemia control (if ≥ 1 year interval from the last statin dose, the patient is eligible for study entry)

Keywords: gastric cancer, unresectable/metastatic
vfend special investigation for prophylaxis

Conditions: Fungal Infection

Summary: examine the safety and effectiveness of vfend \[voriconazole\] for prophylaxix use under general clinical practices.


Eligibility criteria:
inclusion criteria: * patients undergoing hsct (hematopoietic stem cell transplantation). exclusion criteria: * patients who have been previously enrolled in this study.
study of the effect of the cognitive orientation to daily occupational performance (co-op) on cognitive impairment in parkinson's disease

Conditions: Parkinson's Disease; Cognitive Impairment

Summary: the purpose of the study will be to determine the effects of the cognitive orientation to daily occupational performance (co-op) as a treatment program for individuals with parkinson's disease-related cognitive impairment. the potential effects of the co-op on successful engagement in meaningful activities will be examined from participants' and live-in caregivers' perspectives. effects of the co-op on participant-perceived health-related quality of life and caregiver burden will also be evaluated. hypotheses: 1. training with the co-op will have an effect or multiple effects on participation in meaningful activities and health-related quality of life for individuals with parkinson's-related cognitive impairment. 2. training with the co-op will have an effect or multiple effects on caregiver burden and health-related quality of life for caregivers of individuals with parkinson's-related cognitive impairment.


Eligibility criteria:
inclusion criteria for participants with parkinson's disease: * clinical diagnosis of idiopathic parkinson's disease * presence of a live-in caregiver or significant other who is willing to participate in the study * montreal cognitive assessment (moca) score above 16/30 and below 26/30 * schwab and england activities of daily living scale scores between 60% and 90% * hoehn and yahr scale scores between stage 1 and stage 3 * self-reported difficulty completing routine functional activities that may be related to new cognitive changes since pd diagnosis exclusion criteria for participants with parkinson's disease: * clinical diagnosis of atypical parkinsonism * clinical diagnosis of young-onset parkinson's disease * co-morbidities associated with cognitive impairment * poorly controlled depression * clinical diagnosis of dementia * residence outside boundaries of the city of winnipeg, manitoba, canada inclusion criteria for caregiver participants: * live in the same residence as participant with parkinson's * be willing to participate exclusion criteria for caregiver participants: * scores at or below 16/30 on montreal cognitive assessment (moca)

Keywords: cognitive orientation to daily occupational performance co-op
amphetamine induced adult respiratory distress syndrome

Conditions: Burns; Acute Lung Injury; Acute Respiratory Distress Syndrome; Methamphetamine Abuse

Summary: methamphetamine and amphetamine has various cardiovascular and central nervous system effects. long-term use is associated with many adverse health effects including cardiomyopathy, hemorrhagic, and ischemic stroke. death is usually caused by cardiovascular collapse and while amphetamine abuse has been considered as a potential cause of acute respiratory distress syndrome, the reports are usually anecdotal. this investigation considers reviewing individuals with few to zero medical conditions who develop acute respiratory distress syndrome and are methamphetamine positive

methamphetamine and amphetamine has various cardiovascular and central nervous system effects. initially prescribed in the 1930s for respiratory ailments such as asthma, current clinical indications of amphetamine range from treatment of attention deficit hyperactivity disorder to narcolepsy. the mechanism of action is primarily potentiation of release of monoamine neurotransmitters, mainly dopamine and norepinephrine, from presynaptic nerve endings into the synaptic space, in addition to attenuation of monoamine metabolism by inhibiting monoamine oxidase. this in turn leads to an increase in sympathetic tone by alpha and beta adrenergic receptor activation, resulting in elevations in heart rate, respiratory rate, and vascular tone. long-term use is associated with many adverse health effects including cardiomyopathy, hemorrhagic and ischemic stroke. other long-term associations include increased violent behavior, documented increased motor vehicle accidents, and clandestine manufacturing of the drug. methamphetamine has also been associated with deleterious effects on society as a whole; it is credited as a cause of increase in rates of crime, abuse, and unemployment, and associated with great economic burden. a significant portion of healthcare resources consumed are rooted in the emergency department, particularly in trauma. studies previously performed have demonstrated that methamphetamine use among patients that present to trauma centers has been continually increasing. death is usually caused by cardiovascular collapse and while amphetamine abuse has been considered as a potential cause of acute respiratory distress syndrome, the reports are usually anecdotal. this investigation considers reviewing individuals with few to zero medical conditions who develop acute respiratory distress syndrome and are methamphetamine positive

Eligibility criteria:
inclusion criteria: * total body surface area burns between 20% and 60% admitted to the burn unit exclusion criteria: * under 18 years of age * burns outside of the inclusion ratio
prophylactic infusion of donor lymphocytes in cord blood transplantation

Conditions: Leukemia

Summary: pilot, multicentric, open-label, single-arm, phase i-ii clinical trial to evaluate the safety and efficacy of a novel umbilical cord blood transplantation (ucbt) platform, that consists of a ucbt of the 80 fraction, followed by a donor lymphocyte infusion (dli) of the 20 fraction (between 60 and 90 days after transplantation).

multicenter, open-label, single-arm, phase i-ii pilot study in which a minimum of 20 patients will enter the study with the primary objective to assess the safety and secondary objective to assess efficacy in relation to immune reconstitution followed by a new platform of treatment consisting of initial cord blood unit 80 fraction transplantation, followed by a prophylactic donor lymphocyte infusion (dli) of the fraction 20 of the cord blood unit. the second infusion will take place between 60 and 90 days after transplantation.

Eligibility criteria:
inclusion criteria: at the time of transplantation: * patients under 60 years with proposal ucbt according to assistance protocol * diagnosis of high-risk acute leukemia with an indication of allogenic transplantation * frozen ucb bag split into two bags: one with the 80% of the product and another with the 20% * presence of at least 1.2e9 total nucleated cells and\> 1e5 cd34 / kg and\> 6e6 cd34 + in fraction 80% * 4/6 or better compatibility taking human leukocyte antigen (hla) hla-a, hla-b by antigenic resolution and drb1 by allelic resolution * the patient (or legal representative if required) has signed the informed consent at the time of dli: * documented cord blood engraftment * the patient has had no graft versus host disease (gvhd) during the first 60 days post-transplantation or, if present, receives less than 10 milligrams of prednisone at the time of the dli or \<0.2 mg / kg / day of prednisone for pediatric patients (\<16 years). * the patient has less than 200 cd4 + cells per microliter on peripheral blood at 60 days (± 7 days) post-transplantation * the patient (or legal representative if required) has signed the informed consent exclusion criteria: at the time of transplantation: * simultaneous participation in another clinical trial or treatment with other research phase product within 30 days prior to inclusion in the study. * pregnant women or those who intend to become pregnant within 12 months after the signing of the informed consent or not taking proper contraceptive measures according to investigator criteria. * breastfeeding women * other pathologies or circumstances that may compromise the patient's participation in the study according to the criteria of the investigator. at the time of dli: * grade iii-iv gvhd after allogeneic ucb * prednisone treatment (\> 10 mg total per day in adults or\> 0.2 mg / kg / day prednisone for pediatric patients)

Keywords: high-risk acute leukemia graft versus leukemia dli ucbt
evaluating therapeutic electrical stimulation to improve nerve healing after surgical repair of digital nerve injuries

Conditions: Digital Nerve Injury; Nerve Injury; Nerve Reconstruction; Nerve Trauma; Digital Nerve Lesion

Summary: the goal of this clinical study is to evaluate if a period of electrical stimulation delivered during the surgical repair procedure can speed up nerve healing.


Eligibility criteria:
inclusion criteria: * age 18-80 years * candidate for surgical intervention under general anesthesia. * require primary nerve injury repair in at least 1 digital nerve. * following resection, have a resulting nerve gap of ≤ 10mm. * able to complete tension-free end-to-end direct repair, or repair with a conduit, autograft, or allograft with a length ≤15mm * signed and dated informed consent form. exclusion criteria: * severe comorbid conditions, such as arrhythmia or congestive heart failure, preventing surgery under general anesthesia. * nerve repair occurring \>1 month post-injury. * incomplete nerve transection. * injury requiring replantation of target digit * injury distal to the distal interphalangeal joint. * injury proximal to branching into the proper or common digital nerves. * injuries to both digital arteries of an affected digit. * history of neuropathy, diabetic neuropathy, or any other known neuropathy * history of chronic ischemic condition of the upper extremity * cognitive impairment preventing the ability to provide consent, follow post-operative instructions, or complete clinical assessments.

Keywords: nerve repair therapeutic electrical stimulation bes brief electrical stimulation
the effect of metformin as an adjuvant therapy on immunological parameters in egyptian patients with rrms: a pilot study

Conditions: Multiple Sclerosis (MS) - Relapsing-remitting

Summary: this pilot study aims to investigate the tolerability and feasibility of using metformin as an adjuvant treatment for rrms. also, it aims to evaluate the preliminary evidence of its efficacy by analyzing outcomes related to immunology, clinical manifestations, and radiological findings.


Eligibility criteria:
inclusion criteria: * individuals between 18 and 50 years of age who met the 2017 mcdonald criteria were recruited. * patients with rrms and had an edss score below 7.0. * participants were required to have been on a stable ifnβ-1a regimen for at least six months before the commencement of the study. exclusion criteria: * individuals taking metformin or other diabetes medications, pregnant, and breastfeeding females were excluded. * those with congestive heart failure, liver impairment, kidney dysfunction, or chronic respiratory conditions were not eligible to participate. * additionally, patients who had undergone corticosteroids before or within 4 weeks of the study's commencement were ineligible for participation.
meta-analysis of efficacy of topotecan

Conditions: Cervical Intraepithelial Neoplasia

Summary: this meta-analysis was conducted to investigate the efficacy of topotecan and other treatments for recurrent and stage ivb carcinoma of the cervix

studies included in the meta-analysis were: gog-0179, gog-0204 \& gog-0169

Eligibility criteria:
inclusion criteria: * randomised clinical trials or systematic reviews or meta-analyses * treatment with topotecan or platinum-based single and combination regimens in female patients of any race with cancer of the cervix recurrent after radiotherapy or stage ivb disease exclusion criteria: * none
analysis of the clinical and histological correlation of oral graft-versus-host-disease (gvhd)

Conditions: Graft-Versus-Host Disease

Summary: introduction: graft-versus-host-disease (gvhd) is the major cause of morbidity and mortality in patients submitted to the bone marrow transplantation (bmt). the oral manifestations can be very debilitating and interfere in the results of medical therapy, leading to systemic complications, committing the prognosis and quality of life of the patient. the early diagnosis can be done through biopsies of oral mucosa with or without apparent injury clinic. the association between the clinical and histopathological tables of gvhd, especially through the use of recent consensus established in these areas, can bring new benefits to physicians. objective: this study aims to apply and compare the two classifications histological to gvhd, horn (1995) and consensus (2006) in specimens obtained from clinical oral lesions suggestive of gvhd; correlate them with clinical classification according akpek (2001) and with the survival of the patients.

methods: for this study we analyzed histological samples of oral mucosa of 10 patients with clinical diagnosis of gvhd, which have areas of epithelium, and salivary gland. the histopathological aspects were observed by the author of this work and his advisor, so blinded by applying the criteria for horn and the consensus. we consistency between the two classifications obtained and histological correlation with the clinical classification of gvhd (akpek, 2001) and the curve of survival.

Eligibility criteria:
inclusion criteria: * all patients with clinical signs of oral gvhd that underwent oral biopsy exclusion criteria: * samples without epithelium or minor salivary glands

Keywords: oral manifestations bone marrow transplantation adverse effects
post-operative efficacy and safety study

Conditions: Post-operative Pain

Summary: the purpose of this study was to compare the analgesic efficacy of 5 mg oxymorphone ir with placebo in patients with mild to moderate pain following outpatient knee arthroscopy.


Eligibility criteria:
inclusion criteria: * males or females, 18 years of age or older, who have completed outpatient knee arthroscopy * have an initial pain intensity score of between 30mm and 70mm on a 100mm visual analogue scale(vas) and a categorical pain rating scale of none, mild, moderate, or severe, * have been informed of the nature of the study and provided written informed consent exclusion criteria: * have a positive pregnancy test * have received any of the following medications within 24 hours prior to dosing: cox2 inhibitors, minor tranquilizers, muscle relaxants, antihistamines * long-acting oral and parenteral analgesics are prohibited for at least 12 hours prior to receiving study medication. * have received any of the following medication within 48 hours prior to dosing: chronic use of analgesics (opioid or non-opioid including aspirin \[\>325 mg/day\], acetaminophen, and nsaids) * have received maoi drugs within 2 weeks prior to dosing * not stabilized on the following medications for at least 4 weeks prior to dosing: tricyclic antidepressant drugs, serotonin reuptake inhibitors, amphetamines used for adhd
effect of preoperative aspirin in patients undergoing off-pump coronary artery bypass grafting

Conditions: Coronary Artery Disease; Aspirin

Summary: effect of preoperative aspirin in patients undergoing off-pump coronary artery bypass grafting. a double-blind, placebo-controlled, randomized trial.


Eligibility criteria:
inclusion criteria: * eligible patients undergoing off-pump coronary artery bypass grafting (opcab) * patients in whom antiplatelet therapy was stopped 5-7 days prior to opcab exclusion criteria: * patients undergoing on-pump coronary artery bypass grafting * patients in whom antiplatelet therapy was not stopped 5-7 days prior to opcab * intraoperative conversion to on-pump coronary artery bypass grafting * patients with inherited blood-clotting disorders * patients undergoing other cardiac operations

Keywords: opcab asa aspirin
leukemia and lymphoma society (lls) services impact on outcomes and care

Conditions: Leukemia; Lymphoma; Myeloma; Myelodysplastic Syndromes; Myeloproliferative Neoplasm

Summary: the purpose of this study is to learn about the impact that the services and programs provided by the leukemia and lymphoma society have among patients with blood cancer, such as access to care, quality of life, and financial burden.


Eligibility criteria:
inclusion criteria: * be currently receiving primary or relapse treatment for a diagnosis of leukemia, lymphoma, myeloma, myelodysplastic syndromes (mds), or myeloproliferative neoplasms (mpn) * report experiencing at least one unmet need addressed by the lls program (i.e., medical care including second opinions, travel for care, clinical trial access, financial and insurance needs, supportive programs, disease and treatment education) * not be currently participating in any lls programs or services * be willing to be followed for 6 months * speak english or spanish exclusion criteria: * are not receiving primary or relapse treatment for a diagnosis of leukemia, lymphoma, myeloma, myelodysplastic syndromes (mds), or myeloproliferative neoplasms (mpn) * are not experiencing unmet needs addressed by the lls program (i.e., medical care including second opinions, travel for care, clinical trial access, financial and insurance needs, supportive programs, disease and treatment education) * are currently participating in any lls programs or services * are not willing to be followed for 6 months * do not speak english or spanish.

Keywords: blood cancer