Kornimate/medical-research-clean huggingface dataset:
probiotic for osteoarthritis

Conditions: Osteoarthritis of Multiple Joints

Summary: the gut microbiome appears to be a significant contributor to musculoskeletal health and disease. microbiome composition and its functional implications have been associated with prevention of bone loss and/or reducing fracture risk. genetic background, gender, dietary intake, and social factors are also important factors which contribute to the musculoskeletal health, as well as to the normal balance of intestinal microbiota. the link between gut microbiota and joint inflammation in murine models of arthritis has been established, and it is now receiving increasing attention in human studies. recent papers have demonstrated substantial alterations in the gut microbiota in patients with rheumatoid arthritis (ra) and osteoarthritis (oa). these alterations resemble those established in systemic inflammatory conditions (inflammatory bowel disease, spondyloarthritides, psoriasis), which include decreased microbial diversity and lower abundances of bacteria belonging to the firmicutes phylum that are known to have immunoregulatory properties.these new findings open important future horizons both for understanding disease pathophysiology and for developing novel biomarkers and treatment strategies. further investigation into the mechanisms linking changes in the microbiome to alterations in bones and joints is necessary. next generation sequencing, metatranscriptomic analysis, and metabolomic approaches may provide yet-greater insight and help further understand these mechanisms. to investigate gut microbiota change will be associated with the sintoms of knee and / or hip oa in italian patients.


Eligibility criteria:
inclusion criteria: * all subjects will have hip or knee oa according on radiographic findings (kellgren-lawrence scale ≥3). a physiatrist (physician) will establish the diagnosis of pain-oa. exclusion criteria: * psychiatric or neurological disorders, celiac disease, lactose intolerance, or allergies or other ongoing illnesses (i.e., irritable bowel syndrome, diabetes, ulcerative colitis, etc.) or recent antibiotic treatment (i.e., \<3 months before the beginning of the study). * participants require treatment with aspirin \> 325 mg /day. * participants who smoked more than 10 cigarettes per day were excluded. * participants will be excluded also if they score greater than 6 points on the beck depression inventory (bdi) or more than 30 points in the state trait anxiety inventory (stai), dementia and not italian speaking due to the high level of language skills required for questionnaires and quantitative sensory testing. * post-traumatic oa (e.g., fractures), congenital hip deformities, surgical interventions to the hip or knee, legg-calvé-perthes disease, or degenerative or non-degenerative neurological conditions in which pain perception is altered will be excluded

Keywords: osteoarthritis microbiota probiotic
comparative motility of alloplastic orbital implants

Conditions: Anophthalmos; Acquired; Evisceration; Traumatic, Eye

Summary: this study will evaluate the effect of posterior placement of orbital implants on their motility compared to intrascleral placement after evisceration .

evisceration allows removal of the intraocular contents while preserving the sclera and normal extraocular muscle attachments. it is more advantageous than enucleation in patients in whom intraocular tumor is rules out. maximizing orbital volume and restoration of movement are important aspects of a successful surgical outcome. standard evisceration techniques do not allow placement of an implant larger than 13-16 mm which don't adequately replace the volume leading to postevisceration socket syndrome. therefore, various techniques have been described to expand the scleral cavity and allow placement of a large implant including anterior sclerotomies, posterior sclerotomies, and disinsertion of optic nerve. implant exposure is a terrible complication of evisceration with reported rates as high as 67%. exposure of the implant can lead to infection, which usually mandates removal of the implant. trying to minimize this risk, physicians intentionally place the implants posterior to the normal position of the globe. some authors described placement of the implant posterior to posterior sclera which totally eliminated the risk of exposure. however, this deep seating of the implant may have deleterious effects on its motility. it can decrease implant-prosthesis interaction. in addition, retro-scleral placement of the implant moves it posterior to the pulleys that serve as the functional origins of rectus muscles. this relationship would be expected to alter the pulling directions of the rectus muscles after evisceration hindering effective implant motility. in this trial the investigators will try to study the effect of posterior placement of the implants on its motility after evisceration.

Eligibility criteria:
inclusion criteria: * patients who are candidates for evisceration exclusion criteria: * inability to provide independent, informed consent * significant preoperative motility abnormalities

Keywords: evisceration orbital implant implant position implant motility
the approach study: a study of volanesorsen (formerly ionis-apociiirx) in patients with familial chylomicronemia syndrome

Conditions: Familial Chylomicronemia Syndrome

Summary: the purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in participants with familial chylomicronemia syndrome


Eligibility criteria:
inclusion criteria: * history of chylomicronemia * a diagnosis of familial chylomicronemia syndrome (type 1 hyperlipoproteinemia) * fasting triglycerides (tg) ≥ 750 mg/dl (8.4 mmol/l) at screening exclusion criteria: * diabetes mellitus if newly diagnosed or if hba1c ≥ 9.0% * other types of severe hypertriglyceridemia * active pancreatitis within 4 weeks of screening * acute coronary syndrome within 6 months of screening * major surgery within 3 months of screening * treatment with glybera therapy within 2 years of screening * previous treatment with ionis-apociiirx * have any other conditions in the opinion of the investigator which could interfere with the participant participating in or completing the study
study of parental ratings of quality of life and body composition in 5-19 year olds while participating in the good news 4 kids program

Conditions: Quality of Life; Body Mass Index

Summary: this study will compare changes in body composition (lean mass, fat, and bone)and parent ratings of quality of life in 5-19 year olds as a function of participation in one of four versions of the good news 4 kids program (gn4k).

purpose: the objectives of this study are to: 1. compare the relative efficacy of four variations of the gn4k program in facilitating positive changes in body composition and parental ratings of quality of life. 2. compare parental ratings of children's behavior to dxa-measured changes in body composition; 3. compare measurements of scale weight, height, waist/hip ratios and bmi with dxa-measured changes in body composition; 4. develop a logarithm formula with the use of anthropometric measurements and parental ratings to predict body composition changes

Eligibility criteria:
inclusion criteria: * must ensure with medical provider that there are not medical conditions that would preclude participation * must be between the ages of 5 and 19 exclusion criteria: * males and females below the age of 5 and above the age of 19 * pregnant or breast feeding

Keywords: quality of life body weight and measures malnutrition adolescent nutrition sciences sleep initiation and maintenance disorder motor activity drinking
brief intervention in at-risk first-time mothers

Conditions: Substance Use

Summary: preliminary controlled trial of a brief intervention designed to reduce child maltreatment risk among low-income pregnant mothers. foci will include major risk factors for maltreatment, including substance abuse, social isolation, depression, violence exposure, and maladaptive child-rearing attitudes/beliefs.


Eligibility criteria:
pregnant, expecting first child inclusion criteria: receipt of public assistance (e.g., medicaid, food stamps), ability to communicate in english exclusion criteria: frank psychosis or other cognitive impairment

Keywords: child abuse, child neglect, substance use, violence exposure, brief intervention
a new technique to produce anatomical alignment results with less midflexion instability in total knee arthroplasty

Conditions: Osteoarthritis, Knee

Summary: beside the current standard of classical mechanical alignment of total knee replacements, increased interest is being shown in anatomical alignment. however, no surgical technique is capable of controlling the stability of the joint in midflexion. the purpose of the present study was to present and evaluate a new surgical technique, which aims to reduce the need for soft-tissue release and optimize stability in midflexion.


Eligibility criteria:
inclusion criteria: * the patients were to undergo surface replacement due to primary osteoarthritis of the knee exclusion criteria: * joints that had undergone open surgery beforehand (e.g. high tibial osteotomy, fracture treatment) were excluded.

Keywords: total knee arthroplasty midflexion instability gap technique anatomical alignment
effect of ozone oil after non-surgical periodontal treatment

Conditions: Periodontal Diseases

Summary: the goal of this clinical trial is to evaluate the use of ozone oil as an adjunctive of non-surgical periodontal treatment (nspt) on diabetics type 2 patients (dm2) compared to control group with chronic periodontal disease. the principal question is to evaluate if the ozone oil could improve periodontal clinical parameters. thirty-two sites of 16 diabetics type 2 patients (dm2) with moderate to advanced periodontal disease containing two sites with periodontal pocket depth (ppd) of \> 5 mm were selected. the treatment was distributed in 2 groups in the split mouth design: control- scaling and root planing + saline solution (control) and test - scaling and root planning + ozone oil


Eligibility criteria:
inclusion criteria: * periodontitis * systemic type 2 diabetes exclusion criteria: * hypersensitivity to ozone oil * osteoporosis types i and ii * alcoholism * immunosuppressio * pregnant and lactating * physical/emotional stress drugs * use of antibiotics, anti-inflammatories and hormone * oral candidiasis * received periodontal treatment in the last six months prior to the procedure

Keywords: periodontitis, periodontal treatment, diabetes
examining the experiences of children with blood disorders

Conditions: Blood Disease; Thrombotic Disorder; Venous Thromboembolism; Hemostatic Disorder; Bleeding Disorder

Summary: this is a 3-phase mixed methods study design. a literature review (phase 1) has been completed to determine the areas of exploration and to identify challenges faced and the impact of the blood disorder on pediatric patients. based on phase 1, phases 2 and 3, as proposed in this study, will be completed and will include interviews of patients diagnosed with bleeding and thrombotic disorders (phase 2). the interviews will be individual, semi-structured, and consist of open-ended questions to elicit unbiased and in-depth responses to gain an understanding of participant's perspectives on themes predetermined in the study design phase.

the purpose of this study is to explore the experiences of pediatric patients with blood disorders, specifically thrombotic, including venous thromboembolism (vte), and hemostatic or bleeding disorders. the information gleaned from this study will help identify specific challenges faced by patients with hemostatic and thrombotic disorders - information that is necessary to develop impactful, evidence-based solutions to support patients with hemostatic and thrombotic disorders cope with the physical, emotional, and psychological impact of blood disorders. participants with blood disorders in this study will participate in open-ended, semi-structured interviews with a study investigator focusing on the psychosocial experiences of patients with diagnosis and treatment of their underlying disorder and the understanding of their diagnosis. female participants additionally will be asked questions about the unique effects of heavy menstrual bleeding, either from their underlying blood disorder or secondary to anticoagulation, on similar aspects of the impact of having a blood disorder. validated questionnaires will be completed to obtain concurrent quantitative data. the interviews will be recorded and transcribed. participation is complete after the interview has finished; participants will continue to receive standard of care treatment during and beyond the study period.

Eligibility criteria:
inclusion criteria: * patients will be eligible to participate if they are between the ages of 12 and 21 years of age, english speaking and have a formal diagnosis of a hemostatic or thrombotic disorder. for thrombotic disorder patients, an additional eligibility criterion will be to include participants within 1 year of diagnosis. exclusion criteria: * patients will be excluded if they do not have access to the technology needed to participate in a virtual interview visit (by telephone).
trial of magrolimab (hu5f9-g4) in combination with rituximab or rituximab + chemotherapy in participants with relapsed/refractory b-cell non-hodgkin's lymphoma

Conditions: Non Hodgkin Lymphoma

Summary: the primary objectives of this study are: * to investigate the safety and tolerability, and to define the recommended phase 2 dose and schedule (rp2ds) for magrolimab in combination with rituximab and for magrolimab in combination with rituximab, gemcitabine, and oxaliplatin (r-gemox). * to evaluate the efficacy of magrolimab in combination with rituximab in participants with indolent lymphoma and diffuse large b-cell lymphoma (dlbcl) and to evaluate the efficacy of magrolimab in combination with r-gemox in autologous stem cell transplant (asct) ineligible dlbcl participants.


Eligibility criteria:
key inclusion criteria: * phase 1b only: b-cell non-hodgkin's lymphoma (nhl), relapsed or refractory to standard approved therapies * dlbcl phase 2 cohort: de novo or transformed diffuse large b-cell lymphoma (dlbcl) expressing cluster of differentiation (cd) 20, relapsed or refractory to at least 2 prior lines treatment containing anti-cd20 therapy * indolent lymphoma phase 2 cohort: marginal zone or follicular lymphoma, relapsed or refractory to standard approved therapies * dlbcl chemotherapy combination cohort: de novo or transformed diffuse large b-cell lymphoma (dlbcl), relapsed or refractory to 1-3 prior lines of treatment * adequate performance status and hematological, liver and kidney functions * willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy key exclusion criteria: * active brain metastases * prior allogeneic hematopoietic cell transplantation * prior treatment with cd47 or signal regulatory protein alpha (sirpα) targeting agents * second malignancy within the last 3 years * known active or chronic hepatitis b or c infection or hiv * pregnancy or active breastfeeding * prior chimeric antigen receptor (car-t) therapy note: other protocol defined inclusion/exclusion criteria may apply.
synbiotic treatment in crohn's disease patients

Conditions: Crohn's Disease

Summary: the purpose of this study is to determine whether administration of a synbiotic, comprised on inulin and a bifidobacterial probiotic will colonise the gut wall and down-regulate tnf-alpha and other pro-inflammatory cytokines in the mucosa of crohn's patients with active disease to reduce mucosal inflammation and induce remission.

crohn's disease is one of the two main forms of idiopathic inflammatory bowel disease. the th1-mediated inflammatory response in crohn's disease is characterised by increased il-18 and inf-gamma and especially tnf-alpha, which are formed by lamina propria mononuclear cells. the aim of this investigation is to determine whether a synbiotic comprised of inulin and a bifidobacterial probiotic, that we have previously shown to down-regulate tnf-alpha and other proinflammatory cytokines in the gut mucosa in ulcerative colitis patients with active disease, can colonise the bowel wall, reduce mucosal inflammation and induce remission in crohn's disease patients with active disease, in a randomised controlled trial. crohn's disease is associated with high mortality and incurs significant social, commercial and nhs costs. many patients are refractile to standard treatments, which often have undesirable side effects. an inexpensive, effective and non-toxic treatment based on the synbiotic concept would contribute greatly to relieving the clinical and financial burdens of the disease.

Eligibility criteria:
inclusion criteria: * crohn's disease of large bowel (+/- small bowel disease) * 18-79 years old * stable doses of medications * cdai \>150, \<450 exclusion criteria: * short gut syndrome * pregnancy * lactation * antibiotic therapy in last 3 months * probiotic therapy in last 1 month * \ 79 years old * cdai \ 450 * indeterminate colitis, ulcerative colitis * alterations to medications in last 3 months

Keywords: crohn's tnf-alpha synbiotic probiotic
sevicontrol-1: efficacy and safety of a fixed combination of olmesartan/ amlodipine

Conditions: Hypertension

Summary: the investigators want to find out whether a recently introduced combination of two blood pressure lowering agents (olmesartan and amlodipine) has a different blood pressure lowering effect than a single active substance. in addition the investigators want to find out whether there is a difference in the changes in blood pressure over the course of a day depending on the time when the medications are taken (in the morning or at night). male and female patients over 18 years of age may participate.

investigation of changes in blood pressure after six weeks therapy with a fixed combination of 40 mg olmesartan and 10 mg amlodipine compared to a monotherapy with 32 mg candesartan. investigation of changes in dipping-profile after a further six weeks of therapy with the fixed combination when time of intake is switched from morning to evening.

Eligibility criteria:
inclusion criteria: * essential hypertension, i. e. systolic opm \>=140 mmhg at screening and \>=160 mmhg after two weeks wash-out exclusion criteria: * systolic office bp \> 180 mm hg at screening visit * known hypertensive retinopathy giii or iv * recent (\< 4 weeks ago) myocardial infarction or indication for coronary or peripheral revascularisation * type i diabetes or poorly controlled (hba1c \>= 8) type ii diabetes * chronic heart failure nyha iii or iv * prior stroke or tia * creatinine clearance \< 60 ml/min or condition after kidney transplant * moderately or severely impaired liver function (alt or ast or bilirubin more than double normal value) * women of childbearing potential without highly effective contraception, pregnant or breastfeeding women * concomitant therapy with lithium * hemodynamically relevant mitral or aortic valve stenosis (\>= ii°) or hypertrophic obstructive cardiomyopathy * concomitant therapy with strong cyp3a4 inhibitors or inductors * african patients * concomitant severe psychiatric condition that might impair proper intake of study medication * life expectancy \< 6 months * night shift workers * known other mandatory indication for treatment with antihypertensive medications

Keywords: hypertension abpm office blood pressure olmesartan amlodipine fixed combination time of intake
efficacy and safety of wen xin granules for the treatment of unstable angina pectoris

Conditions: Coronary Heart Disease; Unstable Angina; Chinese Herbal Medicine

Summary: this is a double-blind, randomized placebo-controlled trial which aims to evaluate the efficacy and safety of wen xin granule in patients with unstable angina pectoris.

coronary heart disease has remained the leading cause of death worldwide over the past decades. unstable angina is a clinical syndrome intermediate in severity between stable angina and acute myocardial infarction with high morbidity and mortality. standard drug therapy and invasive revascularization are effective in decreasing progression to infarction, reducing symptoms and multiple hospitalizations, in most cases without a decrease in the long-term mortality rate. however, there are still many patients with persistence or recurrence of angina despite standard medical therapy and/or revascularization. wen xin granule, as a chinese herbal medicine has shown great effect in patients with unstable angina in our clinical. however, there is still insufficient evidence on his specific efficacy and safety. therefor, we'd like to evaluate the efficacy and safety of wen xin granule in patients with unstable angina through this multi-center, double-blind, randomized placebo-controlled trial.

Eligibility criteria:
inclusion criteria: * aged between 35 and 75 years of age; * diagnosed with cad through coronary arteriography, clinically diagnosed with uap in low or medium risk; * belong to yang deficiency and blood stasis syndrome according to tcm, and give written informed consent. * for the diagnostic criteria of uap, the investigators will refer to 2014 aha/acc guidelines for the diagnosis and management of non-st-elevation acute coronary syndromes. * for the tcm diagnostic criteria, the investigators will refer to guidelines for clinical research into new traditional chinese medicine drugs for chest obstruction (2002 edition). exclusion criteria: * chest pain caused by congenital heart diseases, valvular heart disease, severe neurosis, or arrhythmia * with new york heart association class iii or iv heart failure, in acute phase of cerebral infarction; * with uncontrolled hypertension (systolic blood pressure \>160 mmhg and/or diastolic blood pressure \>95 mmhg in the resting state) * with uncontrolled hyperglycemia or diabetic complications, with mental and neurological abnormalities or dysgnosia; * female patients in pregnancy or lactation; * by participating in other clinical trials.

Keywords: coronary heart disease unstable angina chinese herbal medicine wen xin granule traditional chinese medicine