Kornimate/medical-research-clean huggingface dataset:
study to evaluate the effect of dapagliflozin on the incidence of worsening heart failure or cardiovascular death in patients with chronic heart failure

Conditions: Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)

Summary: the purpose of this study is to evaluate the effect of dapagliflozin on the incidence of worsening heart failure or cardiovascular death in patients with chronic heart failure with reduced ejection fraction

this is an international, multicentre, parallel group, event-driven, randomized, double-blind, placebo-controlled study in patients with chronic heart failure with reduced ejection fraction (hfref), evaluating the effect of dapagliflozin versus placebo, given once daily in addition to background regional standard of care therapy, for the prevention of cardiovascular (cv) death or reduction of heart failure (hf) events.

Eligibility criteria:
inclusion criteria: * provision of signed informed consent prior to any study specific procedures * male or female, aged ≥18 years * established documented diagnosis of symptomatic hfref (nyha functional class ii-iv), which has been present for at least 2 months * lvef≤40% * elevated nt-probnp levels * patients should receive background standard of care for hfref and be treated according to locally recognized guidelines * egfr ≥30 ml/min/1.73 m\^2 (ckd-epi formula) at enrolment (visit 1) exclusion criteria: * receiving therapy with an sglt2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an sglt2 inhibitor * type 1 diabetes mellitus * symptomatic hypotension or systolic bp \<95 mmhg at 2 out of 3 measurements either at visit 1 or visit 2 * current acute decompensated hf or hospitalization due to decompensated hf \<4 weeks prior to enrolment * mi, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment * coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization * implantation of a crt within 12 weeks prior to enrolment or intent to implant a crt device * previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization * hf due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease * symptomatic bradycardia or second or third degree heart block without a pacemaker * severe (egfr \<30 ml/min/1.73 m\^2 by ckd-epi), unstable or rapidly progressing renal disease at the time of randomization

Keywords: hfref heart failure (hf) cardiovascular events (cv) phase iii outcome trial
motivating endometrial cancer survivors with activity monitors and tailored feedback

Conditions: Endometrial Cancer

Summary: overweight and obese endometrial cancer (ec) survivors at the university of north carolina (unc) at chapel hill will be approached for tailored feedback fitness intervention. the investigators plan to enroll 36 women (18 in each arm) to evaluate if receipt of weekly tailored feedback messages can improve physical activity in ec survivors. it is hypothesized that women receiving the feedback message intervention will increase step counts from baseline more than 2,000 steps compared to women in the non-intervention arm.

objectives: * to assess if a tailored feedback fitness intervention can increase physical activity in ec survivors from baseline to 12 weeks post-baseline * to determine the acceptability of the fitness intervention in ec survivors through a completion survey. * to assess if a tailored feedback message fitness intervention can (1) decrease bmi, (2) reduce waitst to hip (w.h) ratios, (3) improve quality of life (qol) and (4) improve serum metabolic markers (insulin, glucose and low density lipoprotein (ldl) in ec survivors.

Eligibility criteria:
inclusion criteria: * be over the age of 18 years * have a confirmed diagnosis of endometrial cancer and have completed therapy (surgery, chemotherapy or radiation) within the past 6 months * have no current evidence of endometrial cancer * have a bmi 25 kg/m2 or greater * have approval from their treating physician to engage in moderate-intensity physical activity. * have a smart phone with bluetooth capabilities turned on * have access to email exclusion criteria: * are currently undergoing treatment for their cancer * are unable to read a sample message aloud * do not have a computer or smart phone with bluetooth capabilities * are pregnant * have a history of angina or palpitations with exertion * have a history of uncontrolled pulmonary disease (copd or asthma) * have one or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention.
safety and efficacy of somatropin in children with growth hormone deficiency

Conditions: Growth Hormone Disorder; Growth Hormone Deficiency in Children

Summary: this trial is conducted in the united states of america (usa). the aim of this trial is to evaluate the safety profiles of norditropin® (lyophilized somatropin) and norditropin® cartridges (liquid somatropin) in children with growth hormone deficiency.


Eligibility criteria:
inclusion criteria: * diagnosis of short stature (height maximum 2 standard deviations of mean for age and gender) or inadequate growth deemed secondary to growth hormone deficiency (ghd) * naïve to growth hormone therapy exclusion criteria: * known or suspected allergy to the trial product or related products * growth retardation attributable to causes other than ghd. growth retardation attributable to diabetes mellitus, inborn errors of metabolism, primary bone disease, chromosomal disorders or disease of the genitourinary, cardiopulmonary, gastrointestinal or central nervous system; bone marrow transplantation or any syndrome known to give short stature (examples are: prader-willi syndrome, russell-silver syndrome, turner syndrome, noonan syndrome) * intrauterine growth retardation: birth weight below 3rd percentile, adjusted for gestational age * pregnancy or the intention to become pregnant * breast-feeding * administration of other growth-altering medication
avenir® cemented hip stem - pmcf

Conditions: Primary Osteoarthritis; Post-Traumatic Osteoarthritis of Hip; Femoral Neck Fractures; Femoral Head Necrosis; Sequelae From Previous Hip Surgery; Osteotomies; Congenital Hip Dysplasia

Summary: the objective of this post-market clinical follow-up study is to confirm the safety and performance of the avenir® cemented hip stem when used in primary total hip arthroplasty.

this is a multicenter, prospective, non-controlled post-market clinical follow-up study to fulfill the post market surveillance obligations according to medical device directive and meddev 2.12-2. the objectives of this study are to confirm the safety and performance of the avenir cemented hip stem when used in primary total hip arthroplasty at 6 weeks to 6 months, 1, 2, 3, 5, 7 and 10 years post-operatively. the avenir cemented hip stem is a straight double-tapered stem offering 9 standard and 9 lateralized versions, the same as the uncemented version, the avenir-mueller stem. safety will be evaluated by monitoring the frequency and incidence of adverse events and through radiographic review. performance will be based on the implant survival, overall pain and functional performances, subject quality-of-life and radiographic parameters of study subjects who received the avenir® cemented hip stem. implant survival will be based on removal or intended removal of the device. a total of 130 patients will be enrolled into the study at up to 4 sites.

Eligibility criteria:
inclusion criteria: * patient is 18 years of age minimum. * patient is suffering from severe hip pain and disability requiring primary unilateral or bilateral total hip arthroplasty based on physical exam and medical history. * patient is willing and able to cooperate in the required post-operative therapy. * patient is willing and able to complete scheduled follow-up evaluations as described in the informed consent. exclusion criteria: * patient is unwilling or unable to give consent, or to comply with the follow-up program. * acute, chronic, local, or systemic infections. * severe muscular, neural, or vascular diseases that endanger the limbs involved. * lack of bony structures proximal or distal to the joint, so that good anchorage of the implant is unlikely or impossible. * total or partial absence of the muscular or ligamentous apparatus. * any concomitant diseases that can jeopardize the functioning and the success of the implant. * allergy to the implanted material, especially to metal (e.g., stainless steel). * local bone tumors and/or cysts. * pregnancy * skeletal immaturity * patients who have any condition that would in the judgment of the investigator place the patient at undue risk or interfere with the study. any patient who is institutionalized, a known drug abuser or alcoholic or anyone who cannot understand what is required of them. * patients with plans to relocate during the study follow-up period. * for patients biologically younger than 60 years with joint disease, a different reconstruction operation (e.g., osteotomy) or arthrodesis may be indicated.

Keywords: total hip arthroplasty hip implant
international registry on the use of the cytosorb adsorber

Conditions: Sepsis; Need of Cardiac Surgery

Summary: registry on the use of the cytosorb® adsorber in icu patients.

the aim of this registry is to record the use of cytosorb® under real life conditions in as many cases as possible (preferably all or, at least, in a representative sample). all cytosorb® applications in different clinical settings and in all patients who are treated with this technology in germany, austria and switzerland (target population) are planned to be included. the objectives of the registry are collection of real-life data on a broad scale, their centralized, structured and comprehensive documentation, and a controlled data exchange. the gathered information will be used to augment the knowledge on the clinical efficacy of the technology, to optimize the quality of its therapeutic application, and to identify and promptly handle possible complications related to the use of cytosorb®. the registry will record all relevant information in the course of product use, e.g. diagnosis, comorbidities, course of the condition, treatment, concomitant medication and clinical laboratory parameters. the registry will inform physicians of different medical specialties about the range of possible applications of cytosorb® and invite them to contribute their own experiences to the registry. this is done by giving them access to their own data and to the results of periodic analyses (for contributing participants), and via publications of the results (for participants and external interested parties) the cytosorb® registry will provide the data base for justified and optimized decisions. an active form of data collection where data is prospectively collected by qualified staff is particularly suited for this purpose. registry data might help closing knowledge gaps and open practical issues. due to the patient group's heterogeneity, the registry can identify sub-groups, assess their risk-benefit-profile and examine their safety profile. registry data are absolutely essential for assessing a therapy's significance within the healthcare landscape. institutions that contribute data to the registry benefit in several ways: they will obtain a continuous retrospective feedback of their own results, their data will be periodically compared with data from other participating sites, and they will get access to regularly published analyses of the results of all participants. on the basis of these data, they can establish a quality monitoring and optimize their use of cytosorb®. the planned endpoints allow for a comprehensive description of cytosorb® efficacy in terms of several indication-relevant aspects. together with the monitoring of application safety, these data build the basis for establishing benchmarks that promote a higher treatment quality.

Eligibility criteria:
inclusion criteria: * use of the cytosorb® adsorber * age ≥ 18 years * signed informed consent exclusion criteria: - none

Keywords: cytosorb adsorber sepsis cytokines hemofiltration hemadsorption inflammation
international registry on the quality of life of patients with grass-pollen-induced allergic rhinitis

Conditions: Allergic Rhinitis Due to Grass Pollens

Summary: the purpose of the present study is to describe patient's perception of quality of life and effectiveness of oralair® over a follow-up period up to 5 years, in real-life settings.

primary objective: to describe the patient's perception of the impact of oralair® on his/her health related generic and disease specific quality of life during the grass pollen season in real-life settings. secondary objectives: - to describe the patient's perceived effectiveness of oralair® in allergic rhinoconjunctivitis management in terms of disease intensity, satisfaction and rescue medication

Eligibility criteria:
inclusion criteria: * patient of 5 years of age and older at the date of the screening visit * patient with proven allergic rhino-conjunctivitis due to grass pollen * patient eligible for a grass-pollen allergen immunotherapy (ait) * patient whose physician prescribed oralair® independently of the study, before the beginning of the grass-pollen season exclusion criteria: * patient participating in a clinical trial or in an epidemiological study

Keywords: allergic rhinitis conjunctivitis grass pollen allergen immunotherapy (ait) grass mix
validation study on the removal of epcam-positive tumour cells from blood collected during tumour surgery using catumaxomab/catuvab device

Conditions: Bladder Carcinoma; Prostate Tumor; Gallbladder Carcinoma; Endometrial Carcinoma; Gastric Carcinoma; Ovarian Carcinoma; Pancreatic Carcinoma; Colon Carcinoma; Non-small Cell Lung Cancer; Peritoneal Carcinomatosis; Kidney Carcinoma; Liver Carcinoma

Summary: the remove study was an open-label, multicenter validation study on the removal of epcam-positive tumor cells from blood collected during tumor surgery using the catuvab kit. the aim of the remove clinical study was to demonstrate the safety and efficacy of the application of the new medical device catuvab to allow retransfusion of autologous erythrocyte product produced by an intraoperative blood salvage (ibs) device during oncological high blood loss surgery. the primary objective of the study was to demonstrate that catuvab device utilized during autologous blood salvage procedures (including ldfs) depletes intraoperative blood of epcam-positive tumor cells.


Eligibility criteria:
inclusion criteria: * intraoperative blood salvage (ibs)-eligible according to the investigator * patients with a prostate tumor, gallbladder carcinoma, bladder carcinoma, endometrial carcinoma, gastric carcinoma, ovarian carcinoma, pancreatic carcinoma, colon / rectal carcinoma, non-small cell lung cancer, or peritoneal carcinomatosis, i.e., cancer types with a high likelihood of being epcam-positive (\>92%) or kidney carcinoma or liver carcinoma. * for patients with cancer types with a high likelihood of being epcam-positive (\>92%): if a tumor tissue sample is available and has been epcam tested or epcam-testing can be done within 5 days of signing the informed consent form (icf): results of epcam typing should be positive. * for patients with kidney carcinoma or liver carcinoma: a tumor tissue sample must be available and have tested epcam-positive prior to surgery. * scheduled for surgery to remove tumor. * the investigator expects that at least 400 ml full blood can be collected during the tumor surgery. * an american society of anesthesiologists (asa) classification of ≤3. exclusion criteria: * adjuvant therapy and intra-operative chemotherapy (hyperthermic intraperitoneal hemotherapy, hipec) started before blood collection for ibs is completed. * lymphocytopenia (count \<1.0 x 109 /l lymphocytes). * cancer different from indicated types, especially typically epcam-negative tumor types. * sepsis occurring during surgery. * cirrhosis of the liver with a child-pugh score of c. * a thrombocyte count of \<30.000/µl. * allergies and/or contraindications against catumaxomab or any of the components or ingredients used in the ibs procedure (e.g., leukocyte depletion filter \[ldf\], diluent, buffer solution or anticoagulants). * active severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection, confirmed by a positive polymerase chain reaction (pcr) test prior surgery.
safety and efficacy study of tranilast in patients with active rheumatoid arthritis (ra)

Conditions: Active Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate whether tranilast at two different dosages compared to placebo is effective in patients with active ra when added to continuing methotrexate (mtx) therapy.

the primary objective of this study is to assess the efficacy and safety of two different doses of tranilast as determined by acr20 response at 12 weeks.

Eligibility criteria:
inclusion criteria: * receiving methotrexate * have at least 8 painful/tender and 6 swollen joints * may be receiving oral steroids, chronic nsaids and/or hydroxychloroquine. exclusion criteria: * use of any anti-arthritic treatments except those allowed in inclusion criteria * pregnant or nursing females * abnormal laboratory values * history of clinically significant renal, hepatic dysfunction, psychiatric disorder, or alcohol/drug dependence * clinically significant systemic infection

Keywords: rheumatoid arthritis
hormonal deficiency in the quality of life of patients with traumatic brain injury

Conditions: Traumatic Brain Injury (TBI)

Summary: the primary objective is to assess the long-term impact of hormonal deficiency on quality of life (qol) in a large group of moderate and severe traumatic brain injury (tbi) patients.

severe traumatic brain injury, when not leading to mortality, is a major cause of morbidity in early adulthood. recent studies have demonstrated a previously unappreciated association between severe traumatic brain injury and endocrine dysfunction. the current trial aims at evaluating the quality of life 18 months post-trauma and associating this outcome to growth hormone levels.

Eligibility criteria:
inclusion criteria: * all subjects must be between the ages of 18-65 * documented moderate to severe traumatic brain injury (tbi) at less than 4 months post injury. * glasgow coma scale (gcs) equal to or greater than 12 * patients volunteer to participate in the study, with a written informed consent signed * bmi between 17 kg/m2 - 30kg/m2 * affiliation to a national health insurance program exclusion criteria: * glasgow coma scale (gcs) ≥13 * history of tbi ≥4 months * anterior hypopituitarism documented * history of radiotherapy * liver dysfunction: total bilirubin \<20µmol/l and/or factor v\<60%) * renal dysfunction: creatinine clearance \< 30 ml/mn (cockcroft \& gault) * anyone who is currently taking or who has taken corticotherapy in the last 4 weeks before tbi * pregnancy * contraindications to mri: * patients who have a heart pacemaker * patients who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain * patients with severe claustrophobia

Keywords: traumatic brain injury quality of life (qol) hypopituitarism,gh
humeral head implants: radiological and clinical evaluation

Conditions: Idiopathic Osteoarthritis; Posttraumatic Osteoarthritis; Humeral Head Necrosis; Instability Arthritis

Summary: in the past years several shoulder reconstruction systems with different types of prostheses and fixation methods have been developed to improve shoulder arthroplasty, trying to cover a wide range of pathologies and revision situations. the aim of the present study is to report radiological and clinical outcome with a stemless shoulder implant with hollow screw fixation.


Eligibility criteria:
inclusion criteria: * age 40 to 85 years at time of surgery * patients with primary or secondary osteoarthritis of the shoulder exclusion criteria: * patients with cuff tear arthropathy and axillary nerve lesions

Keywords: stemless shoulder prosthesis
randomized controlled trial of early palliative care for patients with advanced cancer

Conditions: Cancer

Summary: patients with advanced cancer often have numerous physical and psychological symptoms, which can negatively affect their quality of life. a palliative care team of different health care professionals (including doctors, nurses, social workers and therapists) specializes in treating these symptoms and offers support for patients and their families. however, palliative care teams are currently involved only in the last two months of a patient's life or not at all. the main purpose of this study is to determine whether, compared to conventional cancer care, early involvement by a specialized symptom control and palliative care team in patients with advanced cancer will be associated with: better quality of life, greater patient and caregiver satisfaction with care, better symptom control, improved communication with healthcare providers and improved caregiver quality of life.

twenty-four cancer outpatient clinics at princess margaret hospital, toronto have been randomly assigned so that patients attending them will receive either early palliative care (referral to the palliative care team) or routine cancer care. patients are recruited from gastrointestinal, lung, genitourinary, gynecology and breast clinics and are eligible to participate if they have advanced cancer, and have a life expectancy of six months to two years. patients and their caregivers who agree to participate are asked to complete questionnaires at baseline and every month for 4 months. these questionnaires ask about their quality of life, and satisfaction with their medical care. after they have completed the 4-month questionnaires, some patients and their caregivers will be interviewed, so that they can describe in their own words their quality of life, satisfaction with care, and views about palliative care. these interviews will be audiotaped and analyzed to provide additional information that cannot be obtained by questionnaires alone.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * dx of stage iv cancer (metastatic); refractory to hormonal therapy for breast or prostate cancer; stage iii or iv for lung cancer. * ecog performance status ≤ 2 (estimated by primary oncologist) * prognosis of \>6 months to 2 years (estimated by primary oncologist) exclusion criteria: * insufficient english literacy to complete questionnaires * inability of pass the cognitive screening test (somc - short orientation memory concentration test score \ 10 errors)

Keywords: palliative care quality of life satisfaction with care
comparison of limb size of transverse coloplasty pouch

Conditions: Colon Cancer

Summary: the aim of the study is the comparison of pouch function with two different sizes of limb of transverse coloplasty pouch after rectal resection and total mesorectal excision.

no detailed description necessary, see brief summary.

Eligibility criteria:
inclusion criteria: * all patients in need of rectal resection due to benign or malign disease * \>=18 years exclusion criteria: * anamnestic rectal resection * life expectancy of less than 2 years * pregnancy * \<18 years * missing informed consent

Keywords: size limb transverse coloplasty pouch rectal resection mesorectal excision treatment outcome