Kornimate/medical-research-clean huggingface dataset:
a study to evaluate immune response and safety of two doses of gsk biologicals' hrv liquid vaccine in healthy infants.

Conditions: Infections, Rotavirus; Rotavirus Vaccines

Summary: this study will provide data on the immune response and safety of gsk biologicals' hrv liquid vaccine when given along with the routine infant immunizations in philippines.


Eligibility criteria:
inclusion criteria: * healthy infants between, and including, 5-10 weeks of age at the time of the first dose of hrv liquid vaccine or placebo. * birth weight of the subject should be \> 2000 grams. * written informed consent obtained from the parent or guardian of the subject. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * planned administration/ administration of a vaccine not foreseen by the study protocol except for dtpw, hbv and opv vaccines within 14 days before each dose of hrv liquid vaccine or placebo and ending 14 days after. bcg is administered at birth according to the local epi. * concurrently participating in another clinical study, at any time during the study period. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * history of allergic disease or reactions likely to be exacerbated by any component of the hrv liquid vaccine or placebo. * acute disease at the time of enrolment. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Keywords: placebo double blind gastroenteritis randomized oral live attenuated human rotavirus liquid vaccine
the use of compression bandages in total knee replacement surgery

Conditions: Osteoarthritis

Summary: the use of compression bandages in elective orthopaedic knee surgery is well regarded, however, there is a lack of robust, well-designed evidence to support this. the aim is to determine the feasibility of conducting a randomised control trial comparing the use of a compression bandage worn post-operatively for 24 hours after elective total knee replacement, compared to standard practice (wool and crepe, non-compressive dressing).


Eligibility criteria:
inclusion criteria: * age \> 18 * able to give written, informed consent * primary total knee replacement exclusion criteria: * extensive peripheral vascular disease * lower limb neurological disorder

Keywords: osteoarthritis total knee replacement enhanced recovery compression bandages
regular swimming, vascular function, and arthritis

Conditions: Osteoarthritis

Summary: hypothesis #1: the investigators hypothesize that both swimming training and cycling training will demonstrate significant improvements in endothelium-mediated vasodilation and central artery compliance in this population and that there will be no difference in the magnitude of increases between the water-based and land-based exercise interventions. hypothesis #2: the investigators hypothesize that the improvements in endothelium-dependent vasodilation and arterial compliance in response to exercise training interventions will be related to the corresponding reductions in inflammatory biomarkers. hypothesis #3: the investigators hypothesize that both swimming exercise and cycling exercise will improve functional capacities and disease progression in middle-aged and older adults with osteoarthritis.

middle-aged and older men and women (40-90 years old) of all races and ethnic backgrounds will serve as subjects after obtaining their written, informed consent. all the subjects will have a radiological diagnosis of osteoarthritis according to american college of rheumatology criteria.

Eligibility criteria:
inclusion criteria: * all the subjects will have a radiological diagnosis of osteoarthritis according to american college of rheumatology criteria * subjects will be sedentary (i.e., no regular physical activity for at least the prior 1 year) exclusion criteria: * subjects with significant intima thickening, * plaque formation, and/or characteristics of atherosclerosis. * unstable cardiac or pulmonary diseases. * joint replacement surgery in the previous year. * intraarticular injection nor systemic steroids within previous 3 months. * severe disabling co-morbidity that disallows receiving exercise therapy. * excess alcohol use (\>21 drinks/week). * unwillingness to perform exercise. * fear of water. * mental incapability
penthrox in otolaryngology

Conditions: All Adult Patients Undergoing an Otolaryngology Procedure With Inhaled Methoxyflurane as an Adjunct to Topical or Local Anesthesia

Summary: our objective is to explore the use of methoxyflurane anesthesia as an adjunct analgesic to local anesthesia during in-office otolaryngology procedures in a prospective pilot study. the main outcome of this study will be patient satisfaction with the medication and analgesia. secondary outcomes will include level of sedation and analgesia, patient-reported post-procedural pain levels, and any reported adverse events.


Eligibility criteria:
inclusion criteria: * all adult patients undergoing any of the following procedures with inhaled methoxyflurane as an adjunct to topical or local anesthesia: * skin lesion excision or reconstruction * fine or core needle aspiration biopsy * mucosal biopsy * laryngeal injection or biopsy * myringotomy with or without tympanostomy tube insertion * inferior turbinate reduction * septal button insertion exclusion criteria: * patient unable to complete the post-procedure questionnaire (either due to time constraints, neurocognitive impairment, etc.) * presence of any contraindications to inhaled methoxyfluorane per product monograph: * patients less than 18 years of age * pregnancy, intended pregnancy, or current breast-feeding * inadequate patient understanding or lack of cooperation * decreased level of consciousness or head injury * history of clinically significant renal impairment, e.g., reduced renal output * history of liver dysfunction following previous exposure to halogenated anesthetics * current use of tetracycline antibiotics * personal or genetic history of malignant hyperthermia * muscular dystrophy
association of haptoglobin 2-2 with postoperative delirium

Conditions: Postoperative Delirium

Summary: patients with major orthopedic surgery will be recruited. participants will be monitored for delirium after surgery. participants' blood will be harvested for the determination of haptoglobin types, levels of oxidative stress and inflammation. investigators will then analyze the data to see if haptoglobin 2-2 type is associated with an increased postoperative delirium, inflammation and oxidative stress.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status i to iii class for major orthopedic surgery (hip or knee replacement or spinal surgery) * no psychological and psychiatric history and presentation before surgery * no major organ dysfunction or failure exclusion criteria: * anemia (hemoglobin \< 100 g/l) preoperatively. * requires \> 4 units of allogeneic red blood cell transfusion during the surgery * using steroids or anti-psychological and anti-psychiatric drugs. a small dose of steroid for postoperative anti-nausea/vomiting is allowed and will not be considered as a indication for exclusion. * can not cooperate with the study * history of bleeding * bmi \ 30 * history of hemoglobin metabolism disorder
feasibility study of phototherapy system to treat h pylori

Conditions: Helicobacter Pylori

Summary: this purpose of this study is to determine whether phototherapy can be used to safely and effectively treat h pylori.

h pylori causes almost all peptic ulcers and many gastric cancers and is widely prevalent worldwide. treatment by multiple antibiotics and proton pump inhibitors is effective but are compromised today by significant non compliance due to side effects and duration of required treatment. also, the increase in antibiotic resistance coupled with the decreased availability of new antibiotics project a significant population of patients who will not be treatable with antibiotics. a special, visible-light based phototherapy system has been demonstrated to significantly decrease the viability of h pylori in vitro and in a brief clinical experiment. this study will evaluate the safety and short term efficacy in up to 60 patients of the phototherapy system to treat h pylori.

Eligibility criteria:
inclusion criteria: * age \> 18 and \< 90 * documented positive for h. pylori infection by urease breath test, stool antigen or histology within thirty days prior to procedure * willing to comply with study requirements * able to undergo endoscopic esophagogastroduodenoscopy (egd) with biopsy exclusion criteria: * history of gastric or duodenal carcinoma * history of prior gastric or duodenal surgery * oral or intravenous antibiotics use within previous one month * use of bismuth subsalicylate (pepto bismol) within previous one month * use of photosensitizing drugs or nutritional supplements within previous one month * active peptic ulcer disease (gastric or duodenal ulcer) * esophagitis grade ii or higher * oral or intravenous antibiotics use within previous one month * history of a bleeding disorder or anti-coagulant use that would prevent biopsy * ppi treatment two weeks prior to the scheduled endoscopy * positive pregnancy test * known porphyria * suffer from phenylketonuria (pku) * signs of jaundice * weight \ 250 lb * previously enrolled in this study * participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of this study * the subject is inappropriate for study participation, as determined by the investigator

Keywords: helicobacter pylori phototherapy peptic ulcer gastric cancer
hyperbaric oxygen treatment in autism spectrum disorders

Conditions: Child Autism

Summary: hyperbaric oxygen therapy (hbot) is part of a multidisciplinary therapeutic management of infant autism including psychotherapy, drug treatment and other therapeutics (speech therapy, occupational therapy restrictive diet ...). it has been postulated that children with autism may benefit from hbot due to the potential increase in cerebral perfusion occurring during treatment. in fact, inhaling oxygen above atmospheric pressure could cause an increase in the arterial partial pressure of oxygen, leading to increased oxygen supply to the brain. hbo may also have anti-inflammatory properties due to the reduction in pro-inflammatory cytokines (tumor necrosis factor -α, interferon-γ and interleukins1 and 6). in addition, hbot could improve mitochondrial dysfunction effects, as well as upregulate the production of antioxidant enzymes.thus, hyperbaric oxygen therapy could be tried among the therapeutic arsenal of adjuvant treatments for autism.

autism spectrum disorder (asd) is a neurodevelopmental disorder characterized by difficulties in verbal and non-verbal communication and social interactions. people with asd often exhibit difficult behaviors, including aggressiveness, temper tantrums, irritability, hyperactivity, inattention, impulsivity, self-harm .. the increasing prevalence of autism spectrum disorders (approximately 1%) has increased the need for evidence-based treatment to lessen the impact of symptoms. the ethiopathogenesis of asd has so far been unclear. current pathophysiological theories have demonstrated the presence of cerebral hypo-perfusion, neuro-inflammation, immune dysregulation and oxidative stress involved in the genesis of this disorder. based on its anti-inflammatory effects and increased amount of dissolved oxygen, hyperbaric oxygen therapy has been tried as one of the therapeutic arsenals of adjuvant therapy for autism. this is a randomized controlled study including nearly 80 patients with asd who underwent clinical and neuropsychological evaluation before and after hbot treatment as well as the dosage of the various biochemical and immunological markers. these markers will be assessed before and after the hbot. perfusion mri would also be performed before and after hbo.

Eligibility criteria:
inclusion criteria: * all children aged 4 to 14 years who were followed in the child psychiatry unit during the study period and who were identified as having a diagnosis of asd. this diagnosis was made by child psychiatrists experienced in autism using the dsm-5 criteria and the adi and the childhood autism rating scale (cars) criteria for non-inclusion : * children with hearing or visual impairments * children with unbalanced epilepsy * children with a contraindication to hbot * dysfunction of the immune system exclusion criteria -child that havent completed entire protocol

Keywords: asd - hbot -
italian registry of allergen immunotherapy

Conditions: Allergic Respiratory Disease

Summary: riait (italian registry of allergy immunotherapy) is a multicenter observational study that aims to prospectively collect the most extensive data available on italian patients using ait for respiratory allergies (rhinoconjunctivitis and/or asthma) in a real-life context, through a network of allergy centers with specific interest and expertise in the management of allergic respiratory patients.

objectives include: * evaluate short and long-term real-life effectiveness and safety of ait overall, in specific patient groups' phenotypes and with specific ait products. * evaluate the pertinence and differences in suggesting ait to a patient comparing physician's evaluation in various settings with established international guidelines, describing the factors associated with treatment choices and changing over time, and promoting interoperability, data sharing, and cross-comparison among centers. * describe long-term respiratory allergic disease evolution in patients treated with ait. * describe the natural history of the patient population with respiratory allergies and identify patient groups describing their illness burden, management patterns, and clinical progression. * promote the creation of accurate, standardized, and efficient processes for diagnosing and treating respiratory allergic diseases, especially with ait. * assess biomarker data to predict diagnosis, treatment response and long-term disease progression.

Eligibility criteria:
inclusion criteria: * age ≥ 1 year * confirmed diagnosis of allergic rhinoconjunctivitis and/or allergic asthma according to eaaci 2019 guidelines. * having been followed by the recruiting center for at least one month: this is considered necessary to establish that the patients are truly affected by allergic respiratory disease and are eligible for allergen-specific immunotherapy; in this period, screening tests are carried out to exclude and/or confirm concomitant diseases (comorbidities). in fact, according to the aforementioned eaaci guidelines, a patient can be defined as truly eligible for allergen-specific immunotherapy only after a preliminary phase in which the patient is treated with symptomatic therapy; this observation period allows a correct evaluation of the real adherence and response to therapy, as well as the identification and appropriate treatment of any comorbidity and the possible elimination of aggravating factors. * having received the prescription of any of the available ait products in italy, irrespectively of the selected allergens and the administration route and schedule. exclusion criteria: there will no be exclusion criteria, in order to allow a real-life vision of the characteristics of these patients eligible for or treated with allergen-specific immunotherapy.
long-term safety and efficacy study and dose-escalation substudy of pf 06838435 in individuals with hemophilia b

Conditions: Hemophilia B

Summary: long-term safety and efficacy follow-up for participants with hemophilia b who were previously treated in the c0371005 (formerly spk-9001-101) study, and a dose-escalation sub-study evaluating safety, tolerability, and kinetics of a higher dose with long-term safety and efficacy follow-up. participants in the substudy do not need to have participated in c0371005.

evaluation of the long-term level of persistence and potential late or delayed adverse events associated with pf-06838435 (formerly spk-9001), assessment of the durability of the transgene expression, and determination of the effects of pf-06838435 on clinical outcomes in individuals who have previously received a single administration of pf-06838435 in the c0371005 study. amendment 2 of this study incorporates a dose-escalation substudy to evaluate the safety, tolerability, and kinetics of a single iv infusion of pf-06838435 at a higher dose than that used in the c0371005 study. the dose-escalation participants will also be followed for long-term safety and efficacy.

Eligibility criteria:
this study is currently only enrolling into the dose-escalation substudy with subsequent long-term follow-up. the eligibility criteria for entry into the dose-escalation substudy is presented below: inclusion criteria: 1. able to provide informed consent and comply with requirements of the study 2. males age 18 to 65 years with confirmed diagnosis of hemophilia b (≤2 iu/dl or ≤2% endogenous factor ix) 3. received ≥50 exposure days to factor ix products 4. no measurable factor ix inhibitor as assessed by the central laboratory and have no prior history of inhibitors to factor ix protein 5. agree to refrain from donating sperm and either abstain from intercourse or use reliable barrier contraception until 3 consecutive semen samples are negative for vector sequences exclusion criteria: 1. evidence of active hepatitis b or c 2. currently on antiviral therapy for hepatitis b or c 3. have significant underlying liver disease 4. serological evidence\* of hiv-1 or hiv-2 with cd4 counts ≤200/mm3 (\* participants who are hiv+ and stable with cd4 count \>200/mm3 and undetectable viral load are eligible to enroll) 5. neutralizing antibody titers to the capsid portion of pf-06838435 above the established threshold 6. sensitivity to heparin or heparin induced thrombocytopenia; sensitivity to any of the study interventions, or components thereof, or drug or other allergy 7. previously dosed in a gene therapy research trial at any time or in an interventional clinical study within 3 months of screening visit 8. any concurrent clinically significant major disease or condition 9. unable or unwilling to comply with the study procedures

Keywords: gene therapy benegene lte hemophilia spk-9001 factor ix fix
effect of tumescent lidocaine on platelet function

Conditions: Postoperative Thromboembolism

Summary: the purpose of this study is to evaluate the effect of lidocaine, delivered into subcutaneous tissue for tumescent local anesthesia, on platelet activation following the tumescent liposuction.

the current research study is intended to examine this hypothesis by determining if tumescent lidocaine increases the results of a test which measures the volume of bleeding which occurs when a tiny standardized incision is made on the forearm. this test is the ba test. the investigators will do ba tests before and after infiltration of lidocaine in the form of tumescent local anesthesia for liposuction and then compare the differences of these ba test results. the purpose of the present research project is to study how platelet function after surgical trauma (liposuction) is affected by tumescent lidocaine. the investigators hypothesize that lidocaine, delivered in the form of tumescent local anesthesia, inhibits surgical trauma-induced platelet activation as measured by the in-vivo klein bleeding area test (www.onlinepft). the klein bleeding area (ba) test is an extension of the classic ivy bleeding time (bt) test. the bt test, an in-vivo test for an abnormal bleeding tendency, involves making a small standardized cut in the skin and measuring the duration of bleeding. the ba test has significantly more sensitivity and specificity than the bt test. this research project is a dosage-response clinical trial in which the predictor variable is the milligram per kilogram (mg/kg) dosage of tumescent lidocaine and the response variable is the bleeding area (ba). a result indicating that tumescent lidocaine does indeed impair post-operative platelet function would justify a subsequent randomized clinical trial of tumescent lidocaine for preventing post-operative thromboembolism.

Eligibility criteria:
inclusion criteria: * patients who have requested tumescent liposuction * healthy adults * asa class i, ii, or iii exclusion criteria: * known allergy to lidocaine * younger than 18 years * positive serology for hepatitis c, hiv * chronic fatigue syndrome * known bleeding disorder * significant psychiatric problems * history of seizures * clinically significant cardiac arrhythmia * conditions predisposing to surgical site infections * active bacterial infection * taking drugs know to affect hemostasis

Keywords: platelets inhibition lidocaine thromboembolism prevention lidocaine effects on platelets
the effects of standard protocol with or without colchicine in covid-19 infection

Conditions: COVID-19

Summary: based on data regarding the effect of colchicine on the modulation of immune system and decreasing cytokine release and inflammation the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect on covid-19 polymerase chain reaction(pcr) positive patients .

80 patients with positive nasopharyngeal swab pcr for covid-19 which were not hypoxic but showed computed tomography involvement compatible with covid-19 admitted in ward (not in intensive care unit) included and randomized in to two groups. all patients received standard treatment protocol including essential minerals, vitamins as antioxidants, antibiotics and kaletra while in one randomly assigned group colchicine would be added.

Eligibility criteria:
inclusion criteria: * patients \>18 years old with nasopharyngeal swab confirmed covid-19 pcr, ct involvement compatible with covid, fever and dyspnea without hypoxemia. exclusion criteria: * patient who is not willing to enter in study * known hypersensitivity to colchicine * hepatic failure * renal failure with egfr\<20 ml/min