Kornimate/medical-research-clean huggingface dataset:
a study about the use of omalizumab in the treatment of food allergy and anaphylaxis

Conditions: Food Hypersensitivity; Anaphylaxis

Summary: this was a retrospective, multi-center observational study conducted across four allergy departments in europe (berlin, leipzig, barcelona, and basel). the study included patients with immunoglobulin e (ige)-mediated food allergy who were treated with omalizumab, either as monotherapy or in combination with oral immunotherapy (oit) between 2002-2022.


Eligibility criteria:
inclusion criteria: * a confirmed history of food allergy, either with or without prior anaphylaxis. * treated with omalizumab, either as monotherapy or in combination with oit. exclusion criteria: none identified.

Keywords: food allergy ige-mediated food allergy
berlin registry of right heart interventions

Conditions: Tricuspid Regurgitation; Pulmonary Regurgitation

Summary: the present study evaluates patients after interventional therapy of valvular diseases of the right heart. follow-up examinations include medical history taking, laboratory measurements and an echo. the aim is to assess the different interventional therapies and their impact on patient's outcome.

the subject of the study is to register interventional therapies of right heart diseases (such as "cardioband" and "edge-to-edge" techniques of the tricuspid valve) performed in berlin/ brandenburg (primarily at the charité, universitätsmedizin berlin). based on the development and the increasing use of interventional therapies in tricuspid and pulmonary valve diseases, the impact on the patients' symptoms and life expectancy after interventions will be investigated. the aim is to identify patient subgroups that benefit the most. primary endpoints: total mortality, cardiovascular mortality, heart failure hospitalization. secondary endpoints: nyha class, ntprobnp, liver and kidney function (laboratory measurements), valve function, cardiac function, and cardiac morphology.

Eligibility criteria:
inclusion criteria: * patients with planned or recent valve interventions of the right heart (tricuspid regurgitation/ stenosis, pulmonary regurgitation/ stenosis) * \>18 years * written, documented consent exclusion criteria: * patients in care or unable to consent * patients who are unable to comply with follow-up examinations * patients who are detained in an institution
healthy mothers on the move

Conditions: Pregnancy; Postpartum Period

Summary: healthy mothers on the move (healthy moms), was a prospective randomized controlled trial that aimed to demonstrate the effectiveness of a healthy lifestyle intervention to reduce risk factors for obesity and type 2 diabetes. this behavioral intervention was tailored to the needs of pregnant and postpartum latino women. this study was conducted between 2004 and 2006 in southwest detroit.

specific aims 1. intervention group participants will have improved levels of protective behaviors (improved daily dietary composition and increased level of physical activity) that reduce the risk of type 2 diabetes compared to control group. 2. intervention group participants will have improved their status on clinical measures of risk for type 2 diabetes (anthropometric and metabolic status) compared to the control group. 3. to assess whether theory-based variables, including changes in attitudes, behavioral and control beliefs, perceived social support and behavioral intention change from baseline, and whether these changes influence behavioral outcomes. 4. to identify aspects of project planning and implementation that contributed to achievement of behavioral and clinical outcomes. measures include recruitment, retention and intervention participation rates, barriers and facilitators of participation; and community involvement in, and satisfaction with, intervention components and project activities; and fidelity of intervention components.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * a resident of southwest detroit * less than 20 weeks gestational at the eligibility screening exclusion criteria: women with: * type 1 or type 2 diabetes * incompetent cervix/cerclage * active thyroid * multiple gestation * cardiac, vascular or pulmonary disease * drug or alcohol addiction * serious physical or mental illness or condition that would substantially interfere with participation in or completion of the entire intervention

Keywords: mexican americans pregnancy diabetes mellitus type 2 prevention community health workers community based participatory research behavioral intervention lifestyle intervention
palonosetron in moderately and highly emetogenic chemotherapy induced nausea and vomiting (study p04935)(completed)

Conditions: Neoplasms; Nausea; Vomiting

Summary: the purpose of this study is to evaluate the efficacy and safety of single iv doses of onicit® (palonosetron) 0.25 mg in the prevention of acute and delayed nausea and vomiting associated with moderate and highly emetogenic chemotherapy.


Eligibility criteria:
inclusion criteria: * patients must be 18 years of age or older. * histological or cytological confirmation of malignant disease. * karnofsky index \>= 50% * naïve to chemotherapy (first cycle of chemotherapy iv with moderate or high emetic risk administered during day 1 of the study, according to modification of the classification of paul hesketh's schema published on annals of oncology 17: 20-28, 2006 (appendix 3). * patients that voluntarily sign the consent form. exclusion criteria: * pregnancy or suspected. * patients during breast feeding. * inability to understand or cooperate with the study procedures. * received any investigational drugs within 30 days before study entry. * received any drug with potential anti-emetic efficacy within 24 hours prior to the beginning of the treatment * seizure disorders requiring anticonvulsant medication. * persistent vomiting due to any organic etiology. * experienced any vomiting, nausea or retching, in the 24 hours prior to chemotherapy. * any systemic disease different to base disease * known current or history of drug or alcohol abuse * gastric outlet or intestinal obstruction

Keywords: antiemetic
study elesclomol sodium in patients with relapsed or refractory acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: this is a phase 1 study to test the safety of escalating doses of elesclomol sodium given to patients with advanced myeloid leukemia.

this aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when administered to patients with advanced myeloid leukemia.

Eligibility criteria:
inclusion criteria: * adults with cytologically confirmed acute myeloid leukemia (aml) that has relapsed after the completion of induction and/or consolidation therapy or has failed to respond to standard induction therapy * ecog performance status of 0-2 * acceptable organ and marrow function during the screening period as defined by the protocol * reliable venous access suitable for study drug infusions exclusion criteria: * significant cardiovascular disease * candidates for hematopoietic stem cell transplant * women who are pregnant or breast-feeding * prior treatment with chronic immunosuppressants * other clinically significant uncontrolled conditions

Keywords: aml leukemia relapsed or refractory aml
biobehavioral determinants of obesity in black women

Conditions: Cardiovascular Diseases; Heart Diseases; Obesity; Telangiectasis

Summary: to examine the biobehavioral determinants of obesity in black as compared with white women.

background: behavioral medicine surveys consistently find that obesity is a treatment-resistant disease that continues to be a significant health problem and that the incidence of obesity is much higher in blacks relative to whites in general, and even higher in black women relative to white women. in fact, an nih program announcement (pa-91-99), stated that "obesity in adults has not declined in the past three decades" and "obesity is particularly prevalent in minority populations, especially among minority women." obesity is an independent risk factor for cardiovascular disease, stroke, and hypertension. obesity is a complex phenomenon involving behavioral, lifestyle, and complex biobehavioral mechanisms. in 1995, there were no prospective studies that simultaneously evaluated a systematic set of psychosocial variables with energy balance (dietary intake, physical activity, resting metabolic rate) determinants that may account for the increased risk for obesity in african-american versus euro-american women. design narrative: after subjects were recruited, psychosocial and energy balance (dietary intake, physical activity, metabolic rate) baseline measures were related to levels of body fat as measured by dexa (dual electron x-ray absorptiometry). the role of these variables were evaluated prospectively to adiposity changes in both white and black women over a 24-month period.

Eligibility criteria:
no eligibility criteria
'rehabilitation for life'

Conditions: Hip Fractures

Summary: despite implementing hospital quality programs after hip fracture surgery older adults often experience a decline in the level of physical function, reduced quality of life; and the mortality and readmission rates are high. early mobilization is important in order to prevent loss of muscle mass; however to prevent morbidity an early start of strength training is also necessary. furthermore, the risk of complications, morbidity, and mortality are associated with insufficient management of pain. the project aims to examine the effect of measuring vital signs and consistent rehabilitation in the primary and secondary sectors in older adults after hip fracture surgery. method/ design: the study is a cluster-randomized stepped wedge study. participants will be recruited among patients admitted to an orthogeriatric ward who are 65 years of age or older and citizens in one of six municipalities. participants are also the health professionals in the orthogeriatric ward and the six municipalities. the six municipalities form six clusters, which are randomized, and every three-month one cluster cross from control to intervention. the study compares usual practice (control) to an intervention named 'rehabilitation of life'. an intervention best described as an empowerment-oriented cross-sectorial program including vital sign measurement and systematic progressive rehabilitation and combined with convenient access for collaboration among professionals. primary outcomes: timed up and go (tug) measured 2 months after the time of operation. the investigators hypothesize that 'rehabilitation of life' for older adults with a hip fracture will result in a significant reduced tug-score in comparison to a practice not offering 'rehabilitation of life'. and as the study is organised across two sectors, the cumulated ambulation score (cas) makes a second primary outcome. it is hypothesised that patients in the intervention group will achieve a significantly reduced tug score compared to usual care.


Eligibility criteria:
inclusion criteria: * patients with a hip fracture * patients of 65 years of age or older * patients admitted to an orthogeriatric ward * patient who are citizens in one og three municipalities exclusion criteria: * patients discharged for permanent residence in nursing homes * patients who cannot participate in a conversation * terminal registered patients.

Keywords: rehabilitation cross-sectorial cooperation older
feedback of treatment intensification data to reduce cardiovascular disease risk (fit)

Conditions: Cardiovascular Disease (CVD) Risk Factors

Summary: the primary research question of this study is to determine whether measuring, reporting and feeding back information to primary care teams on the need for treatment intensification in patients at high risk for cardiovascular disease (cvd) can improve rates of treatment intensification and reduce levels of poorly controlled systolic blood pressure, ldl-c, and a1c.

project description: we propose a cluster randomized trial intervention involving eight or more medical facilities of kaiser permanente northern california (kp) and more than 65,000 patients at high risk for cvd. at intervention facilities, patient-level information obtained from kp's electronic health record on the need for treatment intensification (for systolic blood pressure, ldl-c, and a1c) and on recent medication adherence are added to a population management database and fed back through software currently used by staff working with primary care providers. staff at control facilities continue to use the same population management database and software but only receive information on risk factor levels and selected medications. specific aims: 1. evaluate the effectiveness of measurement and feedback of treatment intensification information in patients at high risk of cvd for improving rates of treatment intensification and for reducing levels of poorly controlled systolic blood pressure, ldl-c, and a1c. 2. evaluate the impact of the intervention, compared with current practice, on total numbers of patient contacts, outpatient visits, and costs of care in relation to improvements in risk factor control. 3. evaluate the effect of this innovation on physician and staff perceptions of the value (effectiveness and efficiency) of the population management program for high-risk patients. relevance: if this translational study shows that feedback of information on treatment intensification leads to higher rates of intensification and improved risk factor control, this finding will have shown a population-level use of health information technology for improving clinical quality and will also have validated treatment intensification as a metric of clinical quality.

Eligibility criteria:
inclusion criteria: among the randomized medical facilities, we will study a population that is drawn from the phase registry and includes patients with at least one of the following: * diabetes, coronary artery disease; congestive heart failure; stroke/tia; peripheral artery disease; chronic kidney disease; hypertension; or hyperlipidemia * phase patients must be in poor control for at least one cvd risk factor and meet study criteria for needing treatment intensification at some point during the 6-month period. exclusion criteria: * all patients eligible for the study will be included in the analyses * there will be no exclusions based on clinical or other criteria.

Keywords: poor risk factor control treatment intensification medication adherence cardiovascular disease (cvd)
phase iii randomized, double-blind, placebo-controlled study of oral iloprost for raynaud's phenomenon secondary to systemic sclerosis

Conditions: Systemic Sclerosis; Raynaud Disease

Summary: objectives: i. evaluate the safety and efficacy of oral iloprost, a prostacyclin analog, in patients with raynaud's phenomenon secondary to systemic sclerosis.

protocol outline: this is a randomized, double-blind study. patients are stratified by participating institution and digital cutaneous ulcers. patients receive oral iloprost or placebo twice daily for 6 weeks. thrombolytic drugs, oral anticoagulants, and heparin are prohibited on study. concurrent therapy with angiotensin-converting enzyme inhibitors for raynaud's is prohibited; calcium channel blockers for severe digital ischemia are allowed as needed. patients are followed at 2 and 6 weeks.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * raynaud's phenomenon secondary to systemic sclerosis (ss) ss meets american college of rheumatology diagnostic criteria * at least 6 raynaud's attacks per week --prior/concurrent therapy-- * no prior participation in oral iloprost study * at least 4 weeks since participation in other investigational drug studies * at least 2 months since prostanoid therapy * at least 12 months since sympathectomy of upper limb * ongoing therapy for systemic sclerosis may continue on study raynaud's therapy discontinued at entry --patient characteristics-- hematopoietic: no platelet disorder hepatic: no bleeding diathesis renal: creatinine clearance (estimated) at least 30 ml/min cardiovascular: no unstable angina pectoris none of the following within 3 months: * stroke * transient ischemic attack * myocardial infarction other: * no active cancer or other uncontrolled disease * no current history of alcohol or drug abuse * no mental disorder precluding compliance * no pregnant or nursing women * negative pregnancy test required of fertile women * adequate contraception required of fertile women

Keywords: raynaud's syndrome arthritis & connective tissue diseases cardiovascular and respiratory diseases rare disease systemic sclerosis
metabolic balance study of apraglutide in patients with short bowel syndrome, intestinal failure (sbs-if) and colon-in-continuity (cic)

Conditions: Short Bowel Syndrome

Summary: the primary objective of the trial is to evaluate the safety of apraglutide in adult subjects with sbs-if and cic.

this is an international, multicenter trial to evaluate the safety of apraglutide in adult participants with sbs-if and cic. the active pharmaceutical ingredient is apraglutide, an investigational glucagon-like peptide-2 (glp-2) analogue. the trial consists of an evaluation period of 52 weeks.

Eligibility criteria:
inclusion criteria: * signed informed consent for this trial prior to any trial specific assessment. * male and female subjects with sbs-if and cic, receiving parenteral support (ps), secondary to surgical resection of the small intestine with \< 200 cm from duodenojejunal flexure. * subject must require parenteral support (ps) at least 2 days per week and be considered stable. * no restorative surgery intended to change ps requirements in the trial period. * age ≥ 18 years at screening. exclusion criteria: * pregnancy or lactation. * body mass index equal or higher than 30 kg/m\^2 at the time of screening. * major abdominal surgery in the last 6 months prior to screening.

Keywords: intestinal failure sbs sbs-if cic colon-in-continuity
lletz under general versus local anesthesia

Conditions: Uterine Cervical Dysplasia

Summary: the investigators conduct a prospective, randomized trial to assess the benefits of performing large loop excision of the transformatione zone (lletz) under local anesthesia and compare it to lletz under general anesthesia. the primary endpoint of this study is women´s satisfaction.


Eligibility criteria:
inclusion criteria: * colposcopy prior to conization * informed consent * histologically proven high grade cervical dysplasia * transformation zone typ 1 or 2 exclusion criteria: * significant language barrier * a personal history of conization * pregnancy * the use of blood thinner * unwillingness to participate * oncological disease * inpatient treatment * women who are not fasting * risk of aspiration * columnar-squamous epithelium border not fully visible

Keywords: conization lletz randomized controlled trial loop excision general anaesthesia local anaesthesia
the effect of insulin detemir in combination with liraglutide and metformin compared to liraglutide and metformin in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe and north america. the aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus liraglutide and metformin in subjects with type 2 diabetes. subjects will continue their own pre-trial metformin treatment during the trial.


Eligibility criteria:
inclusion criteria: * subjects diagnosed with type 2 diabetes, insulin naïve and treated with metformin as monotherapy for at least 3 months prior to screening, at a stable dose of at least 1500 mg/day or metformin (at least 1500 mg/day) and a sulfonylurea (less than or equal to half of the maximum approved dose), both at a stable dose for at least 3 months prior to screening. previous short-term insulin treatment in connection with intercurrent illness is allowed at the discretion of the investigator * hba1c 7.0-10.0% (both inclusive) for subjects on metformin monotherapy * hba1c 7.0-8.5% (both inclusive) for subjects on metformin in combination with a sulphonylurea exclusion criteria: * previous treatment with insulin (except for short-term treatment in connection with intercurrent illness at the discretion of the investigator) * treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 3 months prior to screening * recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the investigator * impaired kidney function * impaired liver function * uncontrolled treated/untreated hypertension * cancer or any clinically significant disease or disorder as judged by the investigator * previous participation in the run-in phase of this trial. re-screening is allowed once * history of chronic pancreatitis or idiopathic pancreatitis
plasma exchange combination of immunosuppressive regimens for auto-immune hepatitis

Conditions: Hepatitis, Autoimmune

Summary: an open-label,pilot study to evaluate the efficacy and safety of plasma exchange combination of immunosuppressive regimens, for the remission of autoimmune hepatitis (aih).


Eligibility criteria:
inclusion criteria: * diagnosed with auto-immune hepatitis based on liver biopsy results, with the indications of immunosuppressive therapy; * high levels of total bilirubin (tb) (≥10 x uln); * high levels of immunoglobulin g(igg) (≥1.5 x uln); * agreed to participate in the trial, and assigned informed consent; exclusion criteria: * the presence of hepatitis a, b, c, d, or e virus infection; * patients with presence of liver cirrhosis or portal hypertension; * primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or wilson disease confirmed by liver biopsy; * pregnant and breeding women; * patients with severe anemia (hemoglobin \< 8 g/dl), leukopenia (wbc \< 2500/mm3), or thrombocytopenia (platelet count \< 50,000/mm3); * severe disorders of other vital organs, such as severe heart failure, cancer; * parenteral administration of blood or blood products within 6 months before screening; * recent treatment with drugs having known liver toxicity; * taken part in other clinic trials within 6 months before screening.