Kornimate/medical-research-clean huggingface dataset:
prevention of acute admission algorithm (patina)

Conditions: Avoid Acute Hospitalizations

Summary: utilization of public health care mirrors the older individual's overall health, and increased need for health care may precede more clear symptoms of acute disease. in a previous retrospective study, we found a significant increase in municipal home care service (minutes/week) in a 12-month period prior to acute hospitalization. this phd-study aims at examining the effect of a software algorithm monitoring older citizens utilization of municipal home care. when home care increases the community nurse is notified and special attention is paid to the individual's current health situation. pro-active health care initiatives may be launched in collaboration with the primary care physician. the intervention is the algorithm.


Eligibility criteria:
inclusion criteria: * community dwelling citizens (+ 65) receiving home and social care in odense, kerteminde and svendborg municipalities. exclusion criteria: * non

Keywords: algorithm community dwelling health care utilization acute hospitalization
feasibility of a cytokine expression profile in immune cells as an orientation tool in therapeutic decisions for auto-inflammatory and auto-immune diseases

Conditions: Rheumatoid Arthritis

Summary: this study will assess the feasibility of using cytokine expression profiles in blood samples as a method for evaluating rheumatoid polyarthritis


Eligibility criteria:
inclusion criteria: * the patient must have given their free and informed consent and signed the consent form * the patient must be a member or beneficiary of a health insurance plan * patient is at least 18 years old * subjects included as patients have rheumatoid polyarthritis according to acr eula 2010, das28\>3.2 criteria * subjects included as controls are healthy volunteers who have no overexpression of cytokines exclusion criteria: * the subject is participating in an interventional study, or is in a period of exclusion determined by a previous study * the subject refuses to sign the consent * it is impossible to give the subject informed information * the patient has had at least 3 months of specific treatment that can potentially impact cytokine profile
comparing individualized vs. weight based protocols to treat vaso-occlusive episodes in sickle cell disease

Conditions: Sickle Cell Disease

Summary: the purpose of this research study is to compare two different ways to give opioid pain medicine to treat sickle cell disease pain that is bad enough to go to the emergency department for treatment. one way uses your weight to decide how much pain medicine to give you while in the emergency department. this is called weight based treatment. the other way uses how much pain medicine you take at home and how much medicine you needed during past emergency department visits to decide how much medicine to give you. this is called patient specific treatment.


Eligibility criteria:
inclusion criteria: * all adult (18 years or older); * sickle cell disease patients with the following genotypes: hgb ss (sickle cell anemia), sc(sickle hemoglobin-c) , and sb+(sickle beta-plus thalassemia) and sb-(sickle beta zero thalassemia) exclusion criteria: * determined to not benefit from opioids and therefore won't receive opioids in any future emergency department visit.
trial of the effect of timing of cholecystectomy during initial admission for mild gallstone pancreatitis

Conditions: Pancreatitis

Summary: randomized trial of laparoscopic cholecystectomy with cholangiogram on admission versus after resolution of pain for mild gallstone pancreatitis.

the purpose of this study is to perform a single-center randomized trial to compare laparoscopic cholecystectomy with intraoperative cholangiogram (ioc) within 24 hours of presentation versus after clinical resolution during index admission for mild gallstone pancreatitis on clinical and patient-reported outcomes. additionally, this study aims to determine patients' values and preferences that influence decision-making regarding treatment options for gallstone pancreatitis. hypothesis: during index admission for mild gallstone pancreatitis, early cholecystectomy within 24 hours of presentation regardless of symptoms or laboratory values versus after clinical resolution results in a shorter 30-day total hospital length of stay.

Eligibility criteria:
inclusion criteria: * diagnosis of gallstone pancreatitis. patients will be considered to have gallstone pancreatitis if they have: 1. upper abdominal pain, nausea, vomiting, and epigastric tenderness 2. absence of ethanol abuse 3. elevated lipase level above the upper limit of normal (\>370 u/l) 4. imaging confirmation of gallstones or sludge * low predicted mortality using the bedside index of severity in acute pancreatitis (bisap) -diagnosis of mild pancreatitis (i.e.,no evidence of organ failure or local or systemic complications) * scheduled for laparoscopic cholecystectomy prior to discharge * lack of any very strong indicator for choledocholithiasis based on the american society for gastrointestinal endoscopy (asge) guidelines * clinical stability as denoted by admission to a non-monitored floor bed. exclusion criteria * pregnancy * severe preexisting medical comorbidities precluding surgery, organ failure, local or systemic complications of acute pancreatitis * chronic pancreatitis * native language other than english and spanish * patient refusal to participate

Keywords: cholecystectomy
single treatment of daxibotulinumtoxina for injection in adults with isolated cervical dystonia (aspen-1)

Conditions: Cervical Dystonia

Summary: this is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of two doses of daxibotulinumtoxina (daxi) for injection (high-dose; low-dose in adult subjects with isolated (primary) cervical dystonia (cd).

approximately 300 subjects, recruited from approximately 80 study centers in the united states (us), canada, and europe will be randomized to daxi for injection high dose, daxi for injection low dose, or placebo group, respectively. subjects will be stratified by treatment center and history of prior treatment with botulinum neurotoxin (bont).

Eligibility criteria:
inclusion criteria: * adults, 18 to 80 years of age * meets diagnostic criteria for isolated cd (idiopathic; dystonic symptoms localized to the head, neck, shoulder areas) with at least moderate severity at baseline (day 1), defined as a twstrs-total score of at least 20, with at least 15 on the twstrs-severity subscale, at least 3 on the twstrs-disability subscale, and at least 1 on the twstrs-pain subscale exclusion criteria: * cervical dystonia attributable to an underlying etiology, (e.g., traumatic torticollis or tardive torticollis) * predominant retrocollis or anterocollis cd * significant dystonia in other body areas, or is currently being treated with bont for dystonia in areas other than those associated with isolated cd * severe dysphagia (grade 3 or 4 on the dysphagia severity scale) at screening or baseline (prior to study treatment) * any neuromuscular neurological conditions that may place the subject at increased risk of morbidity with exposure to bont, including peripheral motor neuropathic diseases (e.g., amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as lambert-eaton syndrome and myasthenia gravis) * previous treatment with any bont product for any condition within the 14 weeks prior to screening * botulinum neurotoxin type a (bonta), except the investigational daxibotulinumtoxina, treatment-experienced subjects who had suboptimal or no treatment response to the most recent bonta injection for cd, as determined by the investigator, or history of primary or secondary non-response to bonta injections, known to have neutralizing antibodies to bonta; or have a history of botulinum toxin type b (rimabotulinumtoxinb \[myobloc/neurobloc\]) injection for cd due to non-response or suboptimal response to bonta

Keywords: daxi cervical dystonia twstrs toxin
the efficacy and safety of tocilizumab for severe rp-ild secondary to systemic diseases

Conditions: Rapid Progressive Interstitial Lung Diseases

Summary: there is no confirmed drug therapy for rp-ild. prognosis is poor of regular treatment. the study is designed to compare efficacy and safety of tocilizumab versus regular treatment in participants with severe rp-ild secondary to systemic diseases.

rp-ild, also known as the acute exacerbation of interstitial lung disease, was defined as an acute, clinically significant respiratory deterioration characterized by evidence of new widespread alveolar abnormality on chest imaging or histopathology. it is rapidly progressive and life-threatening. despite aggressive regular treatments with high-dose glucocorticoids in combination with immunosuppressant drugs such as cyclosporine, tacrolimus, or cyclophosphamide, the post-exacerbation mortality rates remain high. there is no confirmed drug therapy for rp-ild. recently, the exacerbation of interstitial lung diseases secondary to systemic diseases was proved to involve many inflammatory responses, so patients are more likely to benefit from immune regulation therapy. tocilizumab is a monoclonal antibody that inhibits the binding of interleukin-6 (il-6), a multifunctional cytokine that regulates the immune response and inflammation, to its receptor (il-6r). the study is designed to compare efficacy and safety of tocilizumab versus regular treatment in participants with severe rp-ild secondary to systemic diseases.

Eligibility criteria:
inclusion criteria: rp-ild, previous or concurrent diagnosis of systemic diseases exclusion criteria: pregnancy; uncontrolled pulmonary infections; severe cardiovascular, hepatic and renal dysfunction; unstable angina or myocardial infarction; thrombocytopenia； neutrophil reduction； malignant tumor; allergy to tocilizumab
oral nitrite trial for hypertension and metabolic syndrome

Conditions: Metabolic Syndrome; Hypertension

Summary: the objective of the study is to investigate effects of inorganic sodium nitrite on the cardiometabolic and hormonal disturbances observed in a targeted population of overweight/obese adults with metabolic syndrome and hypertension, at risk for insulin resistance and endothelial dysfunction.

cardiovascular disease remains the leading cause of death in the united states and worldwide. several studies have demonstrated that fruit and vegetable rich diets significantly reduced blood pressure and reduced the risk of ischemic stroke and cardiovascular disease in general, the exact mechanisms remain poorly understood. preclinical and clinical research over the last decade has revealed the important vasoprotective effects of nitrates and nitrites with regards to reduction in blood pressure, vascular inflammation and endothelial dysfunction. more recent findings suggest that inorganic nitrate and nitrite therapy may be involved in the regulation of glucose-insulin homeostasis. for this reason, development of an oral formulation of nitrite salt represents a rational avenue of exploration for the treatment of cardiovascular diseases, whereby nitrite would ensure rapid acting effects upon absorption. nitrite could then be oxidized to nitrate via the enterosalivary circulation pathway. in this pathway, about 25% of circulating nitrate is concentrated in the saliva and reduced to nitrite by commensal mouth bacteria with nitrate reductase enzymes. the proposal will investigate the inorganic nitrite effects (in any form) on insulin sensitivity in a targeted population of overweight/obese adults with metabolic syndrome and hypertension, at risk for insulin resistance and endothelial dysfunction. this will be the third human trial using orally delivered nitrite (previously as aqueous solution).

Eligibility criteria:
inclusion criteria: * age 18-60 years * body mass index (bmi) ≥ 30 kg/m2 * hypertension: defined as systolic blood pressure ≥130 and/or diastolic blood pressure ≥85 mm hg * waist circumference: \>102 cm in men, \>88 cm in women exclusion criteria: * positive urine pregnancy test or breastfeeding * concurrent use of medications affecting glucose metabolism (oral hypoglycemics, insulin, atypical antipsychotics) * recent addition or change in dosing of hormonal contraceptive medications (oral contraceptive pill (ocp), intra uterine device (iud), depoprovera shot) * current use of ≥3 anti-hypertensive agents regardless of blood pressure control or normotensive on a single or double agent * current use of phosphodiesterase-5 (pd) inhibitors or organic nitrates. we will not exclude for dietary sources of nitrate/nitrite. * not stable on treatments for the prior three months or not planning to remain on current dose of medications for blood pressure, contraception, etc. * known chronic psychiatric or medical conditions including diabetes, liver or kidney disease or obesity syndromes * thyroid stimulating hormone (tsh) \>8 milli-international unit/ml * smoker * anemia (central lab hemoglobin \< 11g/dl) * active periodontal disease
comparative efficacy of cemiplimab to historical standard of care in france

Conditions: Cancer/Squamous Cell Carcinoma of Skin

Summary: primary objective: -assess the effectiveness of cemiplimab versus other available systemic therapies in patients up to 2018 or say historical system organ class (soc) with metastatic or locally advanced cutaneous squamous cell carcinoma (cscc) who are not candidates for curative surgery or curative radiation, on overall survival (os). secondary objectives: * assess progression free survival (pfs) * to assess duration of response (dor) * to assess objective response rate (orr) * to describe adverse events leading to treatment interruptions and deaths

study duration is approximately 9 months. for the standard of care arm, data of the subjects evaluated between 01 aug 2013 and 01 aug 2018 was observed. for the cemiplimab arm, data of the subjects evaluated between aug 2018 and october 2019 was observed.

Eligibility criteria:
inclusion criteria: all patients: * adult 18 years of age or older * with an unresectable locally advanced cscc (who are not candidates for curative surgery or curative radiation therapy) or metastatic cscc (nodal or distant) * subject alive at start data collection who has received information note and has not opposed to data collection or * subject who died before study initiation and who has not opposed to data collection for research purpose when he/she was alive treatment group: * patient treated by cemiplimab in monotherapy through the catu or patient included in the natu that evolved into the catu. * with an eastern cooperative oncology group (ecog) score of 0 or 1 at the time of cemiplimab initiation control group: * patient treated by any systemic treatment initiated until august 1st , 2018 included * with an ecog score of 0 or 1 at the time of treatment initiation for at least one line of systemic therapy initiated from august 1st 2013 to august 1st 2018. the related treatment line must be among the 3 first systemic treatment lines for patients having initiated more than 3 lines. exclusion criteria: all patients: - patient treated by another anti- programmed cell death receptor-1 (pd1) control group: -patient subsequently treated with cemiplimab the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
registry to monitor berlin heart excor® pediatric vad as a bridge to cardiac transplantation.

Conditions: Ventricular Dysfunction; Ventricular Dysfunction, Left; Ventricular Dysfunction, Right

Summary: the purpose of this post market surveillance is to continue monitoring the safety and effectiveness of the berlin heart excor® pediatric. this surveillance includes an "all-comers" prospective cohort of pediatric (\<22 years of age) patients implanted according to the ifu with the excor® pediatric.

the advanced cardiac therapies improving outcomes network (action) database will be used for the surveillance. the network was developed to determine best practice and improve quality in the pediatric mechanical circulatory support field. the registry protocol and manual of operations will be followed by participating pediatric transplant hospitals. quality assurance of the data will be monitored by the registry's data coordinating center.

Eligibility criteria:
inclusion criteria: * transplant eligible * implanted with excor pediatric per ifu exclusion criteria: * having any contradictions for user per ifu
a study of trastuzumab emtansine in comparison with treatment of physician's choice in participants with her2-positive breast cancer who have received at least two prior regimens of her2-directed therapy

Conditions: Breast Cancer

Summary: this randomized, multicenter, 2-arm, open-label study (th3resa) will evaluate the efficacy and safety of trastuzumab emtansine (t-dm1) in comparison with treatment of the physician's choice in participants with metastatic or unresectable locally advanced/recurrent human epidermal growth factor receptor 2 (her2)-positive breast cancer. eligible participants will be randomized to receive either trastuzumab emtansine 3.6 mg/kg intravenously every 21 days or treatment of the physician's choice. participants continue to receive study treatment until disease progression or unacceptable toxicity occurs. this study is also known under roche study protocol number bo25734.


Eligibility criteria:
inclusion criteria: * adult participants ≥ 18 years of age. * histologically or cytologically documented breast cancer. * metastatic or unresectable locally advanced/recurrent breast cancer. * her2-positive disease by prospective laboratory confirmation. * disease progression on the last regimen received as defined by the investigator. * prior treatment with an trastuzumab, a taxane, and lapatinib. * disease progression after at least two regimens of her2-directed therapy in the metastatic or unresectable locally advanced/recurrent setting. * adequate organ function, as evidenced by laboratory results. * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2. * left ventricular ejection fraction (lvef) ≥ 50% by echocardiogram or multi gated acquisition scan. exclusion criteria: * chemotherapy ≤ 21 days before first study treatment. * trastuzumab ≤ 21 days before first study treatment. * lapatinib ≤ 14 days before first study treatment. * prior enrollment in a trastuzumab emtansine containing study, regardless whether the patient received prior trastuzumab emtansine. * brain metastases that are untreated or symptomatic, or require any radiation, surgery or corticosteroid therapy to control symptoms within 1 month of randomization.
comparison of two insulin aspart formulations in healthy volunteers

Conditions: Diabetes; Healthy

Summary: this trial is conducted in africa. the aim of this trial is to determine if a new formulation (u200) of insulin aspart containing 200 u/ml is bioequivalent to that of a marketed insulin aspart formulation (u100).


Eligibility criteria:
inclusion criteria: * normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant * normal laboratory values, electrocardiogram (ecg), and vital signs unless the investigator considers any abnormality to be clinically irrelevant * body mass index (bmi) 18-26 kg/m\^2 (both inclusive) * weight 60-90 kg * non-smoker exclusion criteria: * any condition requiring the regular use of any medication * known or suspected allergy to the trial product or related products * family history of type 1 diabetes mellitus
gemcitabine and cetuximab in patients with advanced or metastatic biliary tract cancer: a multicenter phase ii study

Conditions: Time to Progression

Summary: the purpose of this phase ii study is to assess the efficacy of combined chemotherapy using gemcitabine and cetuximab for advanced cholangiocarcinoma, excluding gallbladder cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven locally advanced or metastatic unresectable adenocarcinoma of the biliary tract * signed written informed consent * age \> 18 * who ps 0 or 1 at study entry * measurable (diameter ³ 1 cm) / evaluable disease, according to recist criteria * adequate renal (serum creatinin\ 1,5x109/l, platelets\>100x109/l) * life expectancy of at least 12 weeks * effective contraception throughout the study for both male and female patients if the risk of conception exists exclusion criteria: * uncontrolled concurrent cns, cardiac, infectious diseases * previous exposure to epidermal growth factor targeting therapy * known hypersensitivity to any components of study treatments * previous chemotherapy for this cancer * previous malignancy in the last past 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix * pregnancy or breast feeding * medical or psychological conditions that would not permit the patient to complete the study or sign informed consent
non-invasive monitoring of mixed venous oxygen saturation using the capnodynamic method in adults

Conditions: Ventilatory Failure; Cardiac Failure; Mechanical Ventilation Pressure High

Summary: the objective of this study is to compare the accuracy and correlation of the capnodynamic method for measuring mixed venous oxygen saturation (svo2) with the standard reference method (pulmonary artery catheter), with the potential for the capnodynamic method to replace the traditional method in selected cases.

the main objective is to evaluate the accuracy and correlation of mixed venous oxygen saturation (svo2) measured using the capnodynamic method in comparison with the invasive standard method using co-oximetry with a pulmonary artery catheter (pac) swan-ganz, with the potential to replace it in selected cases, in patients who would benefit from hemodynamic monitoring with pac for their clinical management and decision-making. the investigator will also study the following secondary objectives: * to assess whether the capnodynamic method (capno-svo2) detects changes over time in the studied variable (svo2), showing good concordance and magnitude compared to the reference method. * to evaluate the progression and trend of the capno-svo2 method in different clinical situations, such as in adult respiratory distress syndrome and patients with other respiratory pathologies, as well as patients with cardiac conditions. * to assess the ability of the capno-svo2 method to detect changes in mixed venous oxygen saturation in response to therapeutic interventions (e.g., adjustments in mechanical ventilation, use of inotropes, vasopressors, or fluid therapy) or moderate hemodynamic changes. * to evaluate the correlation between mixed venous oxygen saturation measured using the capno-svo2 method and other hemodynamic parameters, such as cardiac output, central venous pressure, and cardiac index.

Eligibility criteria:
inclusion criteria: * age \> 18 years * not participating in any other interventional study at the time of the study. * patients under controlled mechanical ventilation in passive conditions. * situations where the responsible physician deems that, for the benefit of clinical management and therapeutic decision-making, the patient would benefit from the placement of a pulmonary artery catheter (swan-ganz) and/or monitoring of central or mixed venous saturation. * obtaining informed consent. exclusion criteria: * failure to obtain informed consent. * no need for invasive mechanical ventilation.