Kornimate/medical-research-clean huggingface dataset:
bleeding ulcer and erosions study "blue study"

Conditions: Bacterial Infection Due to Helicobacter Pylori (H. Pylori); Peptic Ulcer; Bleeding Ulcer

Summary: a prospective study of bleeding peptic ulcers and/or erosions in the upper gastrointestinal tract - risk-medication, presence of helicobacter pylori, treatment and outcome.

patients admitted to hospital due to hematemesis and/or melena with endoscopic finding of ulcer and/or erosion in the ventricle and/or duodenum are eligible for inclusion in the blue study after an informed consent has been obtained. the gastroscopy must be performed within 72 hours after admission. epidemiological data, comorbidity and past clinical history are recorded in addition to the consumption of defined risk medication and proton-pump inhibitors (ppi) during the last 4 weeks. the forrest classification is used to describe an ulcer if present at endoscopy and endoscopic modalities for treatment are used according to established recommendations. surgery or radiological intervention will be applied if needed. an infection with h. pylori is diagnosed by different methods including a rapid urease test, culture and serology. if one of these tests is positive, the patient will receive triple therapy. to secure successful eradication patients are tested with 13c ubt (breath test) or hp antigen stool test after 3 months and hp igg serology after 6 months. registration of lowest haemoglobin (hb) level during hospitalization and an algorithm to treatment with blood transfusion and/or high dose iv iron will be performed to evaluate alternative treatments to blood transfusions alone. effect of treatment is evaluated at 8 weeks and 6 months. a follow-up gastroscopy and blood test is performed after 2-3 months.

Eligibility criteria:
inclusion criteria: * patients over 18 years who consent to be enrolled in the study * patients with hematemesis and/or melena, anemia or positiv fobt that during gastroscopy are diagnosed with ulcer and/or erosions of the ventricle and/or duodenum. * gastroscopy must be performed within 24 hours of the findings above. exclusion criteria: * patients who do not wish to participate or are not competent to give consent. * patients that due to language problems or other reasons do not understand the content of the information about the study. * patients with erosions without hematemesis, in whom one diagnose possible bleeding source on colonoscopy. * patients with malignant ulcer, ulcer simplex or cameron lesions.

Keywords: helicobacter pylori peptic ulcer erosions bleeding nsaids noac
balance confidence and kinesiophobia in parkinson's disease

Conditions: Parkinson Disease

Summary: 31 patients aged 50-80 years diagnosed with idiopathic parkinson's disease (modified hoehn-yahr stages 1-3) and 31 healthy volunteers. at the start of the study, sociodemographic data for all participants will be recorded. to assess the mental and functional status of parkinson's disease patients, the mini-mental state examination (mmse) and the movement disorder society unified parkinson's disease rating scale (mds-updrs) will be used. balance confidence levels will be assessed using the activities-specific balance confidence scale-6 (abc-6), overall balance using the berg balance scale (bbs), fear of falling using the falls efficacy scale (fes), and kinesiophobia levels using the tampa scale of kinesiophobia (tsk).


Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic parkinson's disease by a neurology specialist. * modified hoehn-yahr staging scale classification between stages 1-3. * mini-mental state examination (mmse) score of 24 or higher. * age between 50-80 years. * volunteered to participate in the study. exclusion criteria: * use of medications, apart from routine parkinson's disease treatments, that could affect balance or muscle strength. * presence of neurological or musculoskeletal conditions other than parkinson's disease. * refusal to participate in the study. * presence of psychiatric disorders. * presence of cognitive impairments.
mesenchymal stromal cells (msc´s) in renal lupus

Conditions: Lupus Erythematosus, Systemic; Lupus Glomerulonephritis

Summary: phase ii clinical trial to assess the dose-response and efficacy of umbilical cord-derived mesenchymal stromal cells (mscs) in severe renal systemic lupus erythematosus (sle).

phase iia trial of escalating doses of intravenous (i.v.) mscs in active sle, followed by a phase iib, triple blind, controlled assessment of the selected msc dosing versus placebo, in sle patients receiving standard of care therapy for severe renal disease,

Eligibility criteria:
inclusion criteria: * fulfilling 1997 updated american college of rheumatology (acr) criteria or 2012 slicc classification criteria for sle * seropositive for antinuclear (≥1:80) and/or anti-dna antibodies * fulfilling following criteria for active renal disease: class iii or iv proliferative disease (isn/rps) renal biopsy within 12 months plus... active urinary sediment (\> 5 red blood cells/high-power field and/or \>8 white blood cells/high-power field and/or cylindruria during the current flare). upc ratio ≥ 1 exclusion criteria: * estimated gfr \< 40ml/min/m2 * addition during prior 3 months of randomization of: bolus methylprednisolone or new immunosuppressive drug or intravenous immunoglobulin (ivig) or plasmapheresis. * addition during prior 6 months of randomization of cyclophosphamide * addition during prior 12 months of randomization of biological anti-b cell therapy * coexisting uncontrolled morbidity; pregnancy or planned pregnancy within next 12 months; uncontrolled infection or neoplastic disease. pending unresolved surgical indication.

Keywords: systemic lupus erythematosus mesenchymal stromal cells lupus nephritis
low-calorie diet and body composition prior to roux-en-y gastric bypass

Conditions: Morbid Obesity; Liver Fat

Summary: losing weight before undergoing roux-en-y gastric bypass (rygb) surgery may reduce liver fat content and size thereby improving surgical outcomes. this study aims to investigate whether a 2-week or 6-week pre-operative liquid formula low-calorie diet (lcd) reduces liver fat further than a conventional food diet prior to rygb using magnetic resonance imaging (mri). the hypothesis is that the 2-week and 6-week liquid formula lcd will reduce liver fat further than the conventional food pre-operative diet.

the morbidly obese subjects (bmi higher then 40 kg/m2) were randomised and assessed at baseline (week 0). after 2 weeks on a low-calorie diet (lcd), participants underwent either roux-en-y gastric bypass (rygb) or continued with a lcd for 4 weeks.the participants will reassess at week 6.

Eligibility criteria:
inclusion criteria: * patients undergoing roux-en-y gastric bypass at imperial weight centre * aged 18 to 60 years * boby mass index of 35 to 55 kg/m2 exclusion criteria: * claustrophobia * pacemaker, metal implant, clips, implanted device, shrapnel or bullets, metal in eyes that precludes magnetic resonance imaging * current pregnancy or breast feeding for females (as determined by a pregnancy test) * a full term pregnancy within the last year for females * treatment with any medication that might affect the study outcomes * haemorrhagic disorders and anticoagulant treatment * history of cancer, excluding skin cancer * history of severe or multiple allergies, severe adverse drug reaction or leucopenia * smokers * regular drinkers of more than three units of alcohol daily * history of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit * regular intake of over-the-counter (otc) medication (other than the occasional paracetamol/aspirin) * poor compliers or subjects unlikely to commit to the 26 week study duration * blood donation within the 12 week period before the initial study dose * use of monoamine oxidase inhibitors (maois) as anti depressant

Keywords: morbid obesity gastric bypass bariatrics diet caloric restriction liver fat appetite
study to determine safety and dosage of optison in pediatric participants

Conditions: Transthoracic Echocardiography; Suspected or Known Structural or Functional Cardiac Abnormality

Summary: study to determine the safety and appropriate dosage of optison in pediatric participants since optison has been tested in adult participants only during the clinical development


Eligibility criteria:
inclusion criteria: * the participant was between ≥9 and \<18 years of age and weighs ≥20 kg. * the participant was clinically indicated to undergo a transthoracic echocardiogram. * the participant had a suboptimal non-contrast echocardiogram defined as ≥2 contiguous segments in any given view that cannot be visualized. * the participant was able to comply with study procedures. * a parent or legal guardian of the participant had signed and dated an informed consent form. * post-menarchal female participants must have had a negative urine pregnancy test at screening and at pre-dose on the day of optison administration. * post-menarchal female participants must have been practicing abstinence, or be using an effective form of birth control (e.g., intrauterine device, oral contraceptives, contraceptive implants or injections, diaphragm with spermicide, cervical cap, or consort use of condom) for at least 30 days before being enrolled in the study exclusion criteria: * the participant was previously enrolled in this study. * the participant received an investigational medicinal product within 30 days before or is scheduled to receive one from time of entry into this study until completion of the follow-up period proposed for this study. * the participant had a known or suspected hypersensitivity to any of the components of optison, blood, blood products, or albumin. * the participant had pulmonary hypertension or unstable cardiopulmonary conditions. * the participant had severe liver disease based on medical history. * the participant had a recent (\<6 months) neurological event. * the participant presented any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month or where study participation may compromise the management of the participant or other reason that in the judgment of the investigator makes the participant unsuitable for participation in the study. * the participant was a pregnant or lactating female, or was a female of childbearing potential not using an acceptable form of birth control (negative urine pregnancy test was also required).

Keywords: contrast-enhanced echocardiography (ce-echo) transthoracic echocardiogram child left ventricular opacification (lvo) left ventricular ejection fraction (lvef) left ventricular endocardial border delineation (lv ebd)
u87 cart in treatment of advanced solid tumor

Conditions: Pancreatic Cancer; Solid Tumor, Adult

Summary: this is a single center, open-label, phase 1 study to evaluate the safety and efficacy of u87 cart in treating advanced solid tumor .

following consent, patients must have tumor tissue evaluated by ihc assay. patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (u87). following manufacture of the drug product, subjects will receive preconditioning prior to u87 infusion. all subjects will be asked to continue to undergo long-term gene safety follow-up.

Eligibility criteria:
inclusion criteria: 1. voluntary informed consent is given; 2. age 18 to 75; 3. patients with pathologically confirmed advanced solid tumor who have failed first-line therapy; or patients who are intolerant to first-line standard therapy and voluntarily give up standard therapy; 4. immunohistochemical (ihc) staining of tumor tissue samples from patients was positive for u87 specific antigen (≥ 2 +, and the expression rate was ≥ 20%); 5. expected survival ≥12 weeks; 6. measurable tumor lesions according to recist 1.1; 7. ecog performance score 0-1; 8. sufficient venous access for mononuclear cell collection; 9. hbc ab positive, hbsag negative can be included in the group when the pcr detection of hbv dna is negative; 10. patients should maintain adequate organ function; 11. dyspnea (ctcae v5.0) ≤ grade 1; blood oxygen saturation\>91% without oxygen inhalation; 12. pregnancy test was negative in women of childbearing age; both male and female subjects should agree to use effective contraceptives during the treatment period and within the following year; exclusion criteria: 1. pregnant or lactating women; 2. uncontrolled active infections; 3. active syphilis, hiv, hepatitis b or hepatitis c infection; 4. congenital immunodeficiency; 5. have serious allergic reaction to any drug to be used in this study; 6. other incurable malignant tumors in the past three years; 7. history or presence of clinically relevant cns pathology such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any cns-related autoimmune disease; 8. have undergone cardiac angioplasty or stent implantation within 12 months, or have a history of myocardial infarction, unstable angina or other clinically significant heart diseases; 9. subjects requiring anticoagulation or long-term antiplatelet therapy; 10. subjects who have undergone major surgery or significant trauma within four weeks before enrolled in the study. 11. other situations that the investigator thinks are not suitable for participating in this study.
avacincaptad pegol open-label extension for patients with geographic atrophy

Conditions: Geographic Atrophy; Age-Related Macular Degeneration

Summary: the purpose of this study is to assess long-term safety of avacincaptad pegol intravitreal administration for patients with geographic atrophy (ga) who completed study isee2008 (gather2) through the month 24 visit on study treatment (either avacincaptad pegol or sham).


Eligibility criteria:
inclusion criteria: * male or female patients aged 50 years or greater diagnosed with ga inside and/or outside of the fovea who completed study isee2008 (gather2) through the month 24 visit on study treatment. * patient must provide new written informed consent for this ole trial prior to participation. * patient must have the ability to return for all trial visits for the duration of the 18-month trial. exclusion criteria: * patient did not complete study isee2008 (gather2) through the month 24 visit on study treatment (either avacincaptad pegol or sham), * patient who had the study drug permanently withdrawn for an ae during isee2008 are not eligible. * patient did not enroll into this ole trial within the 90 day enrollment period. * patient who is pregnant or nursing

Keywords: geographic atrophy; macular degeneration; arc1905; avacincaptad pegol; zimura (previous name); izervay
clinical utility of myprostatescore 2.0 p2

Conditions: Prostate Cancer

Summary: this is an extension of an ongoing study. preliminary results from the ongoing study indicate that the myprostatescore 2.0 (mps 2.0) test is significantly improving early diagnosis of prostate cancer. this extension will allow us to ask the study participants in the ongoing study to share patient-level data for chart abstraction. the specific purpose of this study is to generate high-quality real-world data on the clinical utility of lynxdx's new mps 2.0 test.

the results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidelines. the data from this study will be submitted to a national journal for publication. the study plans to enroll up to 150 physicians. upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as clinical performance and value vignettes (cpv®). cpvs describe patients physicians typically encounter in their daily practice and are not meant to be difficult. in each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis, and 5) treatment and follow-up. each case takes approximately 15-20 minutes to complete and the investigators estimate the time commitment for each round of cpv administration to be approximately 45 - 60 minutes. all responses to the cases will be completed online and will be kept confidential. they will also be asked to submit de-identified charts for patients who meet eligibility criteria. physicians will keep their randomization from the ongoing study, and intervention physicians will have the opportunity to order a diagnostic test for their patients free of charge.

Eligibility criteria:
inclusion criteria: * licensed urologist * have practiced as a urologist for greater than 2 but less than 40 years * commonly treats patients at risk for prostate cancer * practicing in the united states * english-speaking * access to the internet * informed and voluntarily consented to be in the study exclusion criteria: * non-english speaking * not a licensed primary care provider * unable to access the internet * not practicing in the u.s. * do not voluntarily consent to be in the study
autologous dendritic cell vaccine in hiv1 infection

Conditions: HIV Infections

Summary: this study aims to look at the safety and tolerability of immunization with dendritic cell vaccine prepared using the patient's own cells and virus. it also aims to explore the virologic efficacy of the vaccine as determined by a decrease in the viral load 12 weeks after analytic treatment interruption.

this is a phase i/ii, open label, single-arm, single-site clinical trial designed to evaluate the safety and antiviral activity of the apb dc vaccine, a therapeutic vaccine derived from autologous dendritic cells loaded with autologous hiv-1 infected apoptotic cells. the study will be conducted in three phases. the first is the pre-vaccination phase that includes study entry, isolation of autologous virus, and initiation of antiretroviral therapy. once the patient's viral load has been suppressed to undetectable levels (\<50 copies/ml) and sufficient virus has been isolated, the second phase will begin. this includes leukapheresis in order to harvest monocytes and lymphocytes necessary for vaccine preparation. three vaccine doses will be administered subcutaneously every other week. six weeks after the last vaccination, the third phase, analytic treatment interruption (ati) phase, will begin. a fourth, booster dose of vaccine will be given two weeks after the start of treatment interruption. the treatment interruption will be continued for twelve weeks after which the primary hiv provider will decide whether or not antiretroviral therapy should be restarted. cd4 and viral load will be closely monitored throughout the study especially during treatment interruption. follow-up will be continued for 24 weeks after the 12-week treatment interruption.

Eligibility criteria:
inclusion criteria: * confirmed hiv-1 infection. * cd4 greater than or equal to 350 cells/ml within 8 weeks prior to study entry. * plasma hiv-1 rna level of 5000-100,000 copies/ml within 8 weeks prior to study entry. * antiretroviral therapy naive. * willingness to interrupt art for at least 12 weeks. * written informed consent. exclusion criteria: * treatment within 30 days prior to study entry with systemic steroids or other immunosuppressives, or any underlying disease which may require use of such medications during the study period. * receipt of any vaccinations other than routine ones within 6 months of study entry * pregnancy or breastfeeding * previous or current cdc category c event * receipt of any investigational product within 12 weeks prior to study entry.

Keywords: dendritic cell therapeutic vaccine hiv-1 apoptotic cells phase i/ii
experimental peri-implant mucositis in humans

Conditions: Peri-implant Mucositis; Gingivitis

Summary: this is a pilot study. the investigators hypothesize that the peri-implant soft tissue response to de novo plaque accumulation is similar to that of normal gingival tissue in the same subjects. the investigators propose to conduct a controlled clinical trial to evaluate peri-implant soft tissue response to de novo plaque accumulation in comparison to the response of gingival tissue in the same subjects


Eligibility criteria:
inclusion criteria: -male and female ³21 years of age. oral site specific inclusion criteria: * 1) presence of 2 implants in the maxillary or mandibular arch supporting fixed restorations in function for at least 1 year (test) * 2) presence of 2 teeth in the corresponding position of the implant (control); -3) absence of active infections at both test and control sites * 4) absence of radiographic bone loss at both test and control sites * 5) pocket depth ≤4mm at both test and control sites * 6) must give written informed consent. exclusion criteria: * 1) treatment with antibiotics for any dental or medical condition within 1 month before screening * 2) systemic diseases that require chronic use of anti-inflammatory medications, antibiotics or anticoagulants * 3) ongoing medications for systemic conditions initiated \<3 months before the start of the study or the requirement to take prophylactic antibiotics for invasive dental procedures * 4) significant organ disease including impaired kidney function, heart murmur, rheumatic fever, bleeding disorder * 5) active infectious diseases such as hepatitis, tuberculosis and hiv * 6) clinically detectable caries and periodontal disease * 7) tobacco use of any kind * 8) use of medications affecting periodontal status (diphenylhydantoin, cyclosporine etc.) * 9) no pregnancy or lactation or expectation to become pregnant within next 3 months. participants will be excluded from the study or analysis if any of the following occur during the study: 1) changes in the patient medical status or medications that met the exclusion criteria; 2) use of antimicrobial rinses; 3) use of irrigating devices; 4) subject noncompliance with stent wearing during the experimental mucositis/gingivitis phase and/or vitamin c use; 5) use of anti-inflammatory drugs or antibiotics; 6) allergic history to common toothpaste or mouth rinse ingredients. acute use of acetaminophen will be permitted.