Kornimate/medical-research-clean huggingface dataset:
study to investigate the treatment benefits of probiotic streptococcus salivarius k12 for hospitalised patients (non-icu) with covid-19

Conditions: Covid19

Summary: this is a randomised, open-label and controlled clinical trial aimed to investigate the adjuvant treatment benefits of probiotic streptococcus salivarius k12 in hospitalised mild-to-moderate patients with covid-19 disease.

boosting the immunity and maintaining a healthy and balanced microflora at oropharyngeal environment of people through probiotics supplementation has been proposed as a possible strategy to protect human host from respiratory tract infections. a slow-dissolved oropharyngeal probiotic formula containing s. salivarius k12 has been clinically demonstrated to improve the upper respiratory tract microbiota protecting the host from pathogenic bacteria, fungi, and viruses, thereby reducing the incidence of viral respiratory tract infections and bacterial co-infections. s. salivarius k12 has been proposed as a promising agent for prophylactic or probiotic treatments to protect individuals during the outbreak of seasonal or emerging respiratory infection diseases. s. salivarius k12 strain, commonly known as blis k12, is a highly safe, and extensively-studied probiotic that resides in the oral cavity. blis k12 has a solid scienctific rationale for helping to prevent streptococcal pharyngitis and/or tonsillitis, ear infections (otitis media) and to help treat halitosis. it is a specific strain of streptococcus salivarius, which secretes powerful anti-microbial molecule called bacteriocin-like-inhibitory substances (blis). the ingredient is believed to support healthy bacteria in the mouth for long-term fresh breath and immune support. it is proposed that the oral administration of the strain k12 to hospitalized covid-19 patients (not already in icu) receiving supplementary oxygen (not invasive oxygen theraphy) to exploit the "ventilation" and helping s. salivarius (k12) to move from the mouth (it is an oral colonizer) to the lungs, colonizing them. the idea is that the lung presence of k12 could strategically reduce the lung and immune capability to release pro-inflammatory cytokines, thus preventing excessive lung inflammation, and the need to proceed to icu and death.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years (both sexes) * hospitalized confirmed (rt-pcr) covid-19 patients (not already in icu) admitted for treatment of covid-19 and not receiving mechanical ventilatory support * patients who have signed informed consent exclusion criteria: * patients with proven hypersensitivity or allergic reaction to the tested formula * patients who decline to participate in the study
506u78 in treating patients with recurrent or refractory cutaneous t-cell lymphoma

Conditions: Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome

Summary: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. phase ii trial to study the effectiveness of 506u78 in treating patients who have recurrent or refractory cutaneous t-cell lymphoma

primary objectives: i. determine the response rate, failure-free survival, and progression-free survival of patients with recurrent or refractory cutaneous t-cell lymphoma treated with 506u78. ii. determine the toxicity of this drug in these patients. iii. study the pharmacokinetics of this drug in these patients. outline: this is a multicenter study. patients receive 506u78 iv over 2 hours on days 1, 3, and 5. treatment continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 6 months. projected accrual: a total of 12-35 patients will be accrued for this study within 3 years.

Eligibility criteria:
inclusion criteria: * histologically confirmed relapsed or refractory cutaneous t-cell lymphoma * large cell transformation of cutaneous t-cell lymphoma allowed * no active cns disease * performance status - zubrod 0-2 * absolute neutrophil count at least 1,000/mm\^3\* * platelet count at least 100,000/mm\^3\* * bilirubin no greater than 1.5 times upper limit of normal (uln) * sgpt no greater than 2.5 times uln * creatinine clearance greater than 50 ml/min * no history of symptomatic cardiac dysfunction * no history of pericardial effusion * hiv negative * no grade 2 or greater sensory or motor neuropathy * no history of seizures * no other malignancy within the past 5 years except curatively treated basal cell carcinoma of the skin of carcinoma in situ of the cervix * no medical, psychiatric, or social condition that would preclude study * no other concurrent serious illness or active infection * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no prior stem cell or bone marrow transplantation (bmt) * no more than 1 prior immunotherapy regimen * no more than 3 prior systemic regimens with denileukin diftitox * at least 3 weeks since prior biologic therapy * no concurrent bmt * no prior 506u78 * no more than 3 prior systemic chemotherapy regimens comprising any of the following: * oral methotrexate * topical mechlorethamine * at least 3 weeks since prior chemotherapy * no other concurrent chemotherapy * at least 3 weeks since prior anticancer endocrine therapy * no concurrent topical or systemic steroids * at least 3 weeks since prior radiotherapy * no more than 3 prior systemic regimens comprising any of the following: * total skin electron beam therapy * spot radiotherapy * no more than 3 prior systemic regimens comprising any of the following: * oral retinoids * ultraviolet therapy (puva) * at least 3 weeks since prior anticancer therapy
peritoneal bacterial contamination following resection with closed or open rectal stump for left-sided cancer

Conditions: Bacterium-Related Malignant Neoplasm

Summary: the purpose of this study is to check if there is a difference in peritoneal contamination in patients undergoing rectal resection with closed and open rectal stump prior to anastomosing.

there is not much information regarding the peritoneal bacterial contamination during colorectal surgery. the null hypothesis is that there is no difference in peritoneal contamination following resection with closed or open rectal stump for left-sided cancer. patients scheduled for elective resection are allocated for open resection with the distal stump closed or open. anastomosis is performed while a clamp is placed on the rectal stump in one arm of the study while in the other arm, the stump remains open until the anastomosis is completed. a second bacterial sample will be obtained at the completion of the anastomosis from the same place (pelvic pouch) as the first one. after sampling an air leak test will be performed. a quantitative assessment of the number of colony forming units (cfu/ml) of aerobic and anaerobic bacteria will be done for each patient. operative time and time interval between samples will be measured. postoperatively, possible complications (surgical site infections, leakage) will be monitored. the primary objective will be to determine the differences in peritoneal contamination between closed and open rectal stump during colorectal surgery.

Eligibility criteria:
inclusion criteria: * consecutive adult patients scheduled for a left colectomy, sigmoidectomy or rectal resection with a proposed anastomosis at the level of the rectum agreeing to participate in the study. exclusion criteria: * patients without informed consent * class v patients on american society of anesthesiologists (asa) of physical health score * patient with prior peritonitis * patients with acute inflammatory bowel disease * recent antibiotic treatment
a study of tcr-redirected t cell infusion in subject with recurrent hbv-related hcc post liver transplantation

Conditions: Recurrent Hepatocellular Carcinoma

Summary: hepatocellular carcinoma (hcc) recurrence rate is high among liver transplant patients, while treatment measures are limited. this study plans to recruit 10 patients with hepatitis b virus (hbv) related hcc who underwent liver transplantation and are confirmed to have recurrent hcc. the objective of the study is to assess the safety, tolerability and effectiveness of the hbv specific t cell receptor (hbv/tcr) redirected t cell in the target population.

this is a phase i, single armed and open labelled trial in patients with recurrent hbv related hcc after liver transplantation. subjects who meet eligibility criteria will receive escalating doses of hbv specific t cell receptor (tcr-t) on day 1, day 8, day 15 and day 22 of the first 28-day treatment cycle, followed by every 2-week dosing on day 1, day 15, day 29 and day 43 of repeated cycle. a 21-day treatment break will be given between each cycle. treatment will be continued until disease progression unless otherwise specified per investigator's discretion. subjects will be followed up post treatment for safety monitoring, including monthly follow up for the first three month and every 2-monthly follow up up to 24 months post treatment.

Eligibility criteria:
inclusion criteria: * diagnosis as hepatocellular carcinoma (hcc) * underwent liver transplantation and confirmed recurrent hcc post operation * seropositive for hepatitis b surface antigen * no major post-operative complication * life expectancy of at least 12 weeks * ability to provide informed consent * ability to comply with study procedures * hla profile matching with hla-class i restriction element of the available t cell receptors exclusion criteria: * administration of any other cell therapy, including nk, cik, dc, ctl, car-t, stem cells or combined therapy of the kind within 3 months prior to enrolment * second primary malignancy that is clinically detectable at the time of consideration for study enrolment * likelihood to require steroid treatment during the period of the clinical trial * any other concurrent liver infections such as hepatitis a, c or d infection * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection * known central nervous system tumours including metastatic brain disease. * any condition that is unstable or which could jeopardise the safety of the patient and his/her compliance in the study * patients with reproductive potential who tested positive for serum or urine pregnancy test result within 14 days prior to enrolment.
a study to evaluate the safety, tolerability, pk and pd of intracerebroventricular gc1123 in patients with mps ⅱ

Conditions: Mucopolysaccharidosis II; Hunter Syndrome

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of intracerebroventricular gc1123 in patients with mps ⅱ who have central nervous system involvement and are receiving treatment with intravenous drug

this study is designed as prospective, open-label, phase i and extension study. safety, tolerability, pharmacokinetic, and pharmacodynamic properties of repeat-dose treatment of icv-administered investigational product will be studied in patients undergoing standard treatments. patients will undergo cerebrospinal fluid (csf) reservoir device implantation surgery on their scalps, and the reservoirs will be used to administer gc1123 to the cerebral ventricles monthly (every 28 days). the planned administering dose is 30 mg. after the 2nd dose on the 6th patient, data and safety monitoring boards (dsmb) will evaluate the safety and tolerability data of gc1123. the planned duration of the sutdy is total about 2 years (phase i and extension)

Eligibility criteria:
inclusion criteria: 1. patient who has been diagnosed with severe mps ⅱ (hunter syndrome) 2. patient, aged 1.5 years (18 months) to 18 years at the time of the screening 3. patient who has received and tolerated a minimum of 12 weeks of treatment with weekly intravenous treatment, and who has received 80% of the total planned infusions within that time frame. 4. patient who is capable of undergoing neurosurgery, which has been confirmed by neurosurgeons and anesthesiologist. 5. patient eligible to execute patient evaluation activities during the clinical trial period, as assessed by the investigator 6. patient whose parents or legal representative are willing to participate in this clinical trial and provide written informed consent form exclusion criteria: 1. patient who has been administered with intrathecal idursulfase in the past 2. patient with a history of bone marrow transplantation or cord blood transplant 3. patient with a history of ventriculoperitoneal shunt or other intracranial surgeries 4. patient with end-stage multiple organ dysfunction syndrome or other severe diseases 5. patient who is exposed to malignant neoplasm 6. patient who has received treatment with any investigational drug or device within 30 days prior to study entry 7. patient who have experience of hypersensitivity or anaphylaxis to ingredients of the investigational product at the time of screening 8. patient with a history of bronchotomy/tracheostomy, or patient with acute respiratory disease at the time of screening 9. patient who is ineligible to participate in the clinical trial due to laboratory test results or other reasons, as determined by the investigator
psychological effects of tai chi training

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: the general purpose of this study is to examine the effect of tai chi training on cognitive function in young adults. the investigators will test subjects enrolled in a semester-long tai chi course along with control subjects. the specific aims are to measure duration of practice, cognitive function, physical balance, and attention deficit hyperactivity disorder (adhd) indicators. the investigators primary hypotheses are that, compared to controls, subjects in the tai chi course will show improvements in (1a) spatial working memory and (1b) response inhibition. the investigators secondary hypotheses are that, among the subjects participating in the tai chi course, these cognitive improvements will correlate with (2a) improvements in balance and (2b) duration of tai chi practice, and that, among all participants, (2c) adhd indications will correlate with cognitive measures.


Eligibility criteria:
inclusion criteria: * able to perform balance and cognitive tests exclusion criteria:
an observational study of mabthera subcutaneous (sc) safety in participants with non-hodgkin's lymphoma (nhl) or chronic lymphocytic leukemia (cll)

Conditions: Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell

Summary: this is a prospective, multicenter, non-interventional study to test the safety and effectiveness of mabthera administered subcutaneously in participants with nhl or cll. the length of study is expected to be 6 years.


Eligibility criteria:
inclusion criteria: * participants administered with mabthera subcutaneously within the approved indication in korea * participants previously untreated with mabthera subcutaneously inclusion criteria for nhl participants for mabthera subcutaneously 1400mg: * relapsed or chemoresistant follicular lymphoma (fl) (b, c, and d type by international working formulation classification of b-cell nhl) participants * previously untreated fl participants in combination with chemotherapy * participants who are treated with maintenance therapy after the treatment of fl participants responding to induction therapy. * cluster of differentiation 20-positive, diffuse large b-cell nhl participants in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone (8 cycles) chemotherapy inclusion criteria for cll participants for mabthera subcutaneously 1600mg: - previously untreated or relapsed/refractory cll participants in combination with chemotherapy exclusion criteria: * pregnant or breastfeeding women * participants who are out of locally approved indications, dosage, and administration including medication error * contraindication in use by locally approved indications, dosage, and administration
lisa vs insure in the treatment of respiratory distress syndrome in preterm infants

Conditions: Preterm Infants

Summary: to evaluate the efficacy of less invasive surfactant administration（lisa ）technique in the treatment of neonatal respiratory distress syndrome（nrds） by comparing with the traditional intubate-surfactant-extubate（insure） technique.

background: neonatal respiratory distress syndrome (nrds) is the most common cause of respiratory problems in premature babies. surfactant administration involved with endotracheal intubation and mechanical ventilation has proven to be a effective treatment, however, it is associated with a risk of barotrauma, volutrauma and bronchopulmonary dysplasia(bpd). in recent years, some studies have demonstrated that prophylactic insure did not lead to a higher survival without bpd, and lisa technique is recommended. however there is no multicenter and large sample research about it. the aim of this multicenter trial is to compare the efficacy between lisa-treated and insure-treated premature preterm babies with respiratory distress syndrome(rds). methods/design：in this multicenter, randomized, cohort, prospective trial, 200 preterm infants from 18 neonatal intensive care units in anhui province whose gestational age (ga) less than 32 weeks with a diagnosis of rds will be randomized to lisa-treated group and insure-treated group. the primary outcomes include rate of intubation,incidence of bronchopulmonary dysplasia(bpd).the secondary outcomes include arterial blood gas analysis,severity of rds,the incidence of patent ductus arteriosus(pda),pneumothorax,abdominal distention,neonatal necrotizing enterocolitis(nec,\>stage ii), retinopathy of prematurity( rop,≥ stage ii), intraventricular hemorrhage (ivh, ≥ grade ⅲ), periventricular leukomalacia(pvl) , mortality, days on noninvasive respiratory support,days on supplemental oxygen and days of hospitalization.other secondary outcomes include scores of gesell development scales of infant development at 3 years of corrected age.

Eligibility criteria:
inclusion criteria: * gestational age (ga) less than 32 weeks * diagnosis of rds. the diagnosis of rds will be based on clinical manifestations (progressive dyspnea, nasal flaring and or grunting), chest x-ray findings and need for noninvasive ventilation support(fraction of inspired oxygen\>40％) in 6 hours after birth * informed parental consent has been obtained exclusion criteria: * severe rds have been treated with endotracheal intubation,surfactant and mechanical ventilation * major congenital malformations or complex congenital heart disease * pulmonary hemorrhage * cardiopulmonary failure * septicemia, intraventricular hemorrhage (ivh, ≥ grade ⅲ), and congenital genetic metabolic disease * transferred out of the nicus(neonatal intensive care units) with surgical treatment or other intervention

Keywords: nrds preterm infants lisa insure
impact of in utero and breastfeeding exposure to tenofovir on renal function in hiv-exposed uninfected children

Conditions: Renal Injury

Summary: the goal of this project is to determine whether and how in utero exposure to tenofovir affects renal function in hiv-exposed uninfected infants

there is a growing use of tenofovir (tdf) in sub-saharan africa with the use of option b+ for prevention of mother-to-child hiv transmission. tdf has been associated to renal function abnormalities both in macaques and hiv-infected adults and infants. therefore concerns have been raised about its renal safety in exposed infants of women on option b+. data for heu is sparse and routine measures of renal function (creatinine, proteinuria), may not be appropriate to detect tdf-associated renal injury early. the goal of our study is to assess whether tdf use in pregnancy and breastfeeding affects the function of the kidney function of the child. pregnant women who consent during their first antenatal consultation to take antiretroviral drugs for pmtct after testing positive, will be enrolled and followed till birth, for adherence using hplc. their terms infants who are hiv negative by dna pcr at 6 weeks (heu), will have urine collected at 1.5, 3, 6, 9 months. using appropriate and more sensitive markers (rbp4, kim1, nag, β2m), proximal tubular function will be assessed in 159 heu infants and same number of controls. nutritional status and drug history data will be collected for both mother and child. rbp, kim1, β2m will be measured using xmap assay while elisa will be used for nag according to manufacturer recommendations. creatinine, phosphates and urinary tract infection will be measured using standard methods. values of these markers will be compared between the 2 groups. results will confirm/infirm renal safety of tdf in pregnancy, improve prevention of long term renal injury through early detection, contribute to promote development of routine rapid diagnostic tests for acute renal tubular injury

Eligibility criteria:
inclusion criteria: * mothers 1. hiv seropositive pregnant women on option b+ protocol containing tdf. 2. hiv seronegative pregnant women 3. pregnant women who provide informed consent. 4. woman is living in yaounde and is not planning to relocate in the next 2 years. children 1. children born to hiv-infected mothers (and hiv-uninfected mothers for controls). 2. tdf- and hiv-exposed in utero (and age-matched unexposed controls). 3. hiv negative after birth by dna pcr 4.0 to 12 months of age (included in study at birth and followed up till 12 months) exclusion criteria: * refusal of parent(s) to give consent

Keywords: tenofovir hiv-exposed infants renal injury
crisiscope: icbt for psychological symptoms related to life crises.

Conditions: Depressive Symptoms; Anxiety Symptoms

Summary: the aim with this study is to investigate the effects of internet-based cognitive behavioral therapy (icbt) on psychological symptoms related to one or more life crises. the target group is adults (18 years or older) who have symptoms of depression, anxiety, stress, or other psychological distress related to one or more life crises. the icbt consists of eight modules during eight weeks with weekly support by a therapist and the treatment group will be compared to a wait-list control condition. participants will be recruited in sweden with nationwide recruitment.

the study is a randomized controlled trial about the effects of icbt aiming to target psychological symptoms related to one or more life crises. primary outcome measures are depressive symptoms (measured with beck depression inventory-ii) and anxiety symptoms (measured with generalized anxiety disorder-7). other outcome measures used will for example be about adaptability, stress symptoms, sleep problems, post traumatic stress symptoms and quality of life. because the psychological impact of a life crisis can be diverse, between different people and between different kinds of crises, a transdiagnostic individually tailored treatment will be used that has been tested in several previous trials. this treatment has been adopted to target psychological symptoms related to life crises.

Eligibility criteria:
inclusion criteria: * experience psychological symptoms related to one or more life crises. * 18 years or older * adequate ability to speak, read and write swedish * having access to the internet and a smartphone, computer or other device exclusion criteria: * severe psychiatric or somatic issues that makes participation harder or impossible * ongoing addiction * acute suicidality * other ongoing psychological treatment * recent (within the past three months) changes in dose of psychotropic medication or planned change during the treatment weeks

Keywords: life crises randomized controlled trial internet-based cognitive behavioral therapy (icbt) internet intervention depression anxiety