Kornimate/medical-research-clean huggingface dataset:
trial to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted globally. the aim of the trial is to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes. the trial is event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the accrual of major adverse cardiovascular events (mace) in this trial and the remaining research programme. the incidence of mace will be monitored throughout the trial which will be terminated according to plan when pre-specified stopping criteria are met.


Eligibility criteria:
inclusion criteria: - men and women with type 2 diabetes mellitus - age above or equal to 50 years at screening and clinical evidence of cardiovascular disease or age above or equal to 60 years at screening and subclinical evidence of cardiovascular disease - anti-diabetic drug naïve, or treated with one or two oral antidiabetic drug (oads), or treated with human neutral protamin hagedorn (nph) insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two oads - hba1c above or equal to 7.0% at screening exclusion criteria: - type 1 diabetes mellitus - use of glucagon-like peptide-1 (glp-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening - use of any dipeptidyl peptidase 4 (dpp-iv) inhibitor within 30 days prior to screening - treatment with insulin other than basal and pre-mixed insulin within 90 days prior to screening - except for short-term use in connection with intercurrent illness - acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening - history of chronic pancreatitis or idiopathic acute pancreatitis - acute coronary or cerebro-vascular event within 90 days prior to randomisation - currently planned coronary, carotid or peripheral artery revascularisation - chronic heart failure new york heart association (nyha) class iv - personal or family history of multiple endocrine neoplasia type 2 (men2) or familial medullary thyroid carcinoma - personal history of non-familial medullary thyroid carcinoma - screening calcitonin above or equal to 50 ng/l
long-term safety and tolerability of idalopirdine (lu ae58054) as adjunctive treatment to donepezil in patients with mild-moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: to evaluate the long-term safety and tolerability of idalopirdine (lu ae58054) as adjunctive therapy to donepezil in patients with mild-moderate alzheimer's disease (ad).

this is an interventional, multi-national, multi-site, open-label extension study in patients with mild to moderate ad who completed the 24-week lead-in study 14861a (nct01955161) or 14862a (nct02006641). patients received 28-weeks of open-label treatment with idalopirdine 60 mg/day (option to reduce to 30 mg/day) as adjunctive treatment to donepezil. approximately 100 patients, who had completed the initial 28-week period (olex), were included in a 24 week open-label treatment period with memantine (olex-mem) that evaluated the safety and tolerability of concomitant memantine therapy in patients who were already on a stable treatment with idalopirdine and donepezil and for whom memantine treatment was clinically indicated.

Eligibility criteria:
inclusion criteria: * the patient has completed visit 7 (completion visit) in the lead-in double-blind, placebo controlled clinical studies 14861a/nct01955161 or 14862a/nct02006641 for patients in the olex-mem: * the patient has completed visit 6 (week 28) of the olex. * the patient, according to the judgement of the investigator, requires initiation of treatment with memantine as per local label/smpc/treatment guidelines. exclusion criteria: * the patient has a moderate or severe ongoing adverse event from the lead-in study considered a potential safety risk by the investigator. * the patient has experienced seizures before completion visit in the lead-in study. * the patient has evidence of clinically significant disease. * the patient's donepezil treatment is likely to be interrupted or discontinued during the study. * the patient is receiving therapy with another acetylcholinesterase inhibitors (achei). other protocol-defined inclusion and exclusion criteria may apply.
ribociclib real-world treatment patterns and clinical outcomes among women with hr+/her2- advanced or metastatic breast cancer in france

Conditions: Breast Cancer

Summary: this study is a national, multicenter, prospective, non-interventional study in women with hr+/her2- locally advanced or metastatic breast cancer (bc), for which a prior clinical decision to initiate ribociclib + endocrine therapy (et) treatment according to the marketing authorization has been taken and was taken independent and prior to study participation decision.

included patients will be followed until the end of study, death or lost to follow-up even if ribociclib and et are discontinued. the end of the study is defined as 3 years after the first visit of the last patient included (last patient first visit \[lpfv\]). the total duration of the study will be 4 years and half (18 months of inclusion + 3 years of follow-up). thus, a patient included at the beginning of the inclusion period will be followed for 4 years and half and a patient included at the end of the inclusion period will be followed for at least 3 years.

Eligibility criteria:
inclusion criteria: patients who meet all of the following criteria will be included in the rosalee study: 1. adult women aged ≥ 18 years old at inclusion. 2. pre-/peri-/postmenopausal women with locally advanced or metastatic hr+/her2- bc. 3. prior clinical decision (independent of study participation)to initiate ribociclib + et treatment according to the marketing authorization. 4. patients having given their non-objection to participate in the study. 5. patients presenting with medical conditions to be treated with ribociclib + et according to the summary of product characteristics. exclusion criteria: 1. patients for whom ribociclib + ai in treatment combination has been initiated before inclusion. 2. patients for whom ribociclib + fulvestrant in treatment combination has been initiated before inclusion. 3. patients for whom ai or fulvestrant in monotherapy has been initiated \> 28 days before inclusion. 4. participation in any clinical study involving investigational therapy except for the trans-rosalee study, conducted by the ipc. 5. patient who is pregnant or has expressed desire for pregnancy during ribociclib treatment.

Keywords: hr+/her2- advanced or metastatic breast cancer rosalee nis france ribociclib
a study of gdc-0919 and atezolizumab combination treatment in participants with locally advanced or metastatic solid tumors

Conditions: Solid Tumor

Summary: this study will evaluate the safety, tolerability, and pharmacokinetics of the combination of gdc-0919 and atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy or for which standard therapy is ineffective, intolerable, or inappropriate. participants will be enrolled in two stages, including a dose-escalation stage and an expansion stage.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 or 1 * life expectancy at least 12 weeks * adequate hematologic and end organ function * negative pregnancy test and willingness to utilize contraception among women of childbearing potential * locally advanced, recurrent, or metastatic incurable solid malignancy with measurable disease per recist v1.1 * progression following at least one standard therapy; or standard therapy considered ineffective, intolerable, or inappropriate; or use of an investigational agent recognized as a standard of care * for the expansion stage, histologically confirmed renal cell cancer (rcc), urothelial bladder cancer (ubc), triple-negative breast cancer (tnbc), non-small cell lung cancer (nsclc), melanoma, head and neck squamous cell carcinoma (hnscc), gastric cancer, ovarian cancer, cervical cancer, endometrial cancer, or merkel cell cancer * for the expansion stage, evaluable for pd-l1 expression * anti pd-1/pd-l1 relapsed cohorts (i and ii), participants whose most recent anti-cancer therapy consisted of single-agent pd-1/pd-l1 blockade will be enrolled exclusion criteria: * significant cardiovascular or liver disease * major surgery within 28 days of study drug * any anti-cancer therapy within 3 weeks of study drug * malabsorption syndrome or poor upper gastrointestinal integrity * primary central nervous system (cns) malignancy or active metastases within 5 years * uncontrolled tumor pain * autoimmune disease other than stable hypothyroidism or vitiligo * human immunodeficiency virus (hiv), active hepatitis b or c, or tuberculosis * signs/symptoms of infection, or use of antibiotics within 2 weeks of study drug * live attenuated vaccine within 4 weeks of study drug * known history or predisposition to qt interval prolongation * prior cancer immunotherapy, specifically indoleamine 2,3-dioxygenase (ido) or tryptophan 2,3-dioxygenase (tdo) inhibitors, t-cell costimulatory receptor agonist antibodies, or checkpoint inhibitors among certain participants
circulating levels of pealbumin in relation to overweight or obesity

Conditions: Obesity

Summary: the study was aimed to investigating the relationship between circulating level of prealbumin and parathormone (pth), triglycerides and triiodothyronine (ft3) in overweight and obese subjects (bmi≥25 kg/m2)


Eligibility criteria:
inclusion criteria: * overweight or obesity (bmi\> 25 kg/m2) exclusion criteria: * any kind of drug hypertension endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.), chronic inflammatory diseases renal failure liver failure angina pectoris myocardial infarction and heart failure genetic heart diseases thrombocytopenias
susan g. komen's shareforcures

Conditions: Breast Cancer

Summary: shareforcures (sfc) is a community-based participatory research registry, and its prime objective is to engage participants representative of the united states breast cancer patient population -including minoritized and historically marginalized people, persons, or communities-to ensure the data researchers use to study breast cancer is as diverse as the people touched by this disease. in doing so, researchers will have a better understanding of breast cancer, and everyone can potentially benefit from scientific advances and improvements in care.

shareforcures (sfc) will be a people-powered, data-driven breast cancer registry that will provide a way for individuals from diverse backgrounds to participate in research and enable participants' data to be used for breast cancer research. the overarching goal of sfc is to create a robust research resource comprised of clinical, biological, socio-behavioral, and other data from up to 200,000 people with breast cancer-including minoritized and historically marginalized people, persons, or communities-to ensure the data, researchers use to study breast cancer, is as diverse as the people touched by this disease. in doing so, researchers will have a better understanding of breast cancer and everyone can potentially benefit from scientific advances and improvements in care.

Eligibility criteria:
inclusion criteria: * individuals must be at least 18 years old. (individuals in alabama and nebraska must be over 19 and individuals in mississippi and pennsylvania must be over 21 to participate). * individuals must have been diagnosed with cancer originating (or is suspected to originate) from the breast. * individuals must be currently residing in the united states or a territory of the united states. * individuals must be able to read and understand english. exclusion criteria: * individuals under the age of 18 years. (individuals in alabama and nebraska under 19 and individuals in mississippi and pennsylvania under 21 are not eligible to participate). * individuals without a diagnosis of breast cancer. * individuals who are not residing in the united states or a territory of the united states. * individuals unable to read and understand english.
feasibility of babygentlestick- adult pilot study

Conditions: Lack of Adverse Events; Reduced Pain Response

Summary: this is a pilot, randomized, safety and efficacy study of an investigational device (i.e. babygentlestick™; bgs, actuated medical, inc). the primary study objectives are to obtain subject feedback, assess device performance; and ascertain potential harm in healthy adult volunteers.


Eligibility criteria:
inclusion criteria: * healthy adult volunteers 18-29 years of age. * fluent in written and spoken english * sex: male or female exclusion criteria: * pregnant women * cognitive impairment * prisoner * individuals with known hematologic conditions or bleeding disorders * individuals with immune disorders where a finger lance puts them at risk for infection.
palliative care for patients with liver cirrhosis

Conditions: End of Life Care; Liver Cirrhosis; Nurse-Patient Relations; Quality of Life

Summary: background: patients with liver cirrhosis rarely receive palliative care although the danish health authorities and who recommend it. the lacking palliative intervention is probably owed to a physician culture focused on life-prolonging active treatment at any cost and unclarities, and misperceptions about palliative care, which is perceived by many as exclusively for cancer patients and something that marks the end of active treatment. study aim: measure the effect of palliative care on the patient burden, caregiver burden, and the utilization of healthcare services. study design: prospective multi-center intervention study with end of study at the patients' death. we will use a 3-faceted endpoint 1) patient burden measured by change in hospital anxiety and depression scale, 2) caregiver burden by a change in zarit caregiver burden questionnaire, and 1) health care system burden as the difference in number, length, and indication for hospital admissions and need for outpatient services. patients: we will prospectively include 200 patients with liver cirrhosis (approx. 50 from each of 4-5 sites: esbjerg, herlev, hvidovre, århus) who have 2 or more items checked on the supportive and palliative care indicators tool. control groups will be identified from two non-participating hospitals and matched regarding age, gender, number of comorbidities, and alcohol and caregiver status. methods: the intervention will be advanced care planning with conversations and actions built around a standardized symptom identification tool (eortc qlq-c15-pal). advance care planning is the collaborative process between patients and health care professionals of planning future health care. the assignment of a contact nurse to each participant is a key part of the intervention. results: we will measure patient and caregiver burden at inclusion, after 4-6 weeks, 4-6 months, and every 6 months until the patient dies. all use of health care services will be registered. the use of health care services during the terminal 2 years will be compared that of control patients.


Eligibility criteria:
inclusion criteria: 1. liver cirrhosis of any etiology (diagnosed clinically, by imaging or histological features) as predominant chronic illness 2. 2 or more items checked on the supportive and palliative care indicators tool (spict™, appendix) 3. expressed desire for palliative support from the patient and relatives 4. ability to give informed consent exclusion criteria: 1. inability to give informed consent 2. age \< 18 years 3. ongoing contact with specialized palliative care teams or hospice 4. other chronic life-threatening illness than liver cirrhosis is more likely to become the cause of death within 1-2 years.
vulvar contact dermatitis resulting from urine incontinence

Conditions: Urinary Incontinence; Vulvar Pruritus; Vulvar Contact Dermatitis

Summary: vulvar contact dermatitis (vcd) is a common problem presenting as vulvar pruritus, burning or irritation. its estimated prevalence is 20-30% in vulvar clinics, but the prevalence in the general population is unknown. contact dermatitis is an inflammation of the skin resulting from an external agent that acts as an irritant or as an allergen. the skin reaction may be acute, subacute or chronic, resulting from prolonged exposure to weak irritating substances. the most common form of vcd is irritant contact dermatitis, and it usually presents as vulvar itch. the causes that contribute to vcd are increased sensitivity of the vulvar skin to irritants compared to other body parts, decrease in the skin barrier function due to exposure to sweat, urine and vaginal discharge and constant friction of the vulvar area. in menopausal women, lack of estrogen contributes to tissue atrophy and thinning, and may increase the effect of irritants on the vulvar skin. one of the most common irritating substances that cause vcd is urine. the phenomenon of urine-induced vcd is known as" diaper rash" in babies, and it was also described in bedridden patients using diapers constantly. women with urine incontinence (ui), a problem that its prevalence in women increases with aging, may use constantly panty liners or pads to prevent urine leakage. the urine is being absorbed in the pad, and the vulvar skin is continually exposed to urine. this can cause vcd, similar to diaper rash. the prevalence of this phenomenon in the general population is unknown. the patients complain of itch, burning or irritation of the vulvar skin, and on exam erythema, edema and irritated skin are found. as most patients do not connect between ui to their vulvar disorder, and as most care-givers do not ask routinely about ui, the vulvar symptoms are mistakenly attributed to yeast infection or other factors. as the cause to the vulvar complaints is not recognized, patients do not receive proper treatment that requires primary management of ui. the aim of the study is to evaluate the prevalence of vcd in women with ui and to recognize risk factors for ui induced vcd.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of vulvar contact dermatitis, with or without urinary incontinence; or * patients with a diagnosis of urinary incontinence, with or without vcd; or * patients without either ui or vcd, age-matched exclusion criteria: * diagnosis of other dermatoses

Keywords: urinary incontinence vulvar pruritus vulvar contact dermatitis
study to evaluate zoledronic acid on quality of life and skeletal-related events as adjuvant treatment in patients with hormone-naïve prostate cancer and bone metastasis who have undergone orchiectomy

Conditions: Prostate Cancer

Summary: an open, multicenter and prospective study to evaluate the impact of the treatment with zoledronic acid 4 mg, on the quality of life and the skeletal-related events in patients with prostate cancer and bone metastasis that responds to hormonal therapy. zoledronic acid is given to patients in a 15 minute-infusion every 4 weeks until a skeletal-related event occurs.


Eligibility criteria:
inclusion criteria: * age ≥18 * histologically confirmed adenocarcinoma of the prostate. * orchidectomy within the four previous weeks to enter the study. * bone metastasis evidenced by bone scan. * a hip dexa study with a ds \< 3. * no hormonal therapy previous to enter the study. * ecog performance score of 0-2. * signed written informed consent. exclusion criteria: * abnormal renal function evidenced by a creatinine clearance ≤60 ml/min. * any kind of hormonal therapy for prostate cancer previous to enter the study. * serum calcium corrected for albumin level \< 8.0 mg/dl. * wbc \< 3.0x10\^3, anc \< 1500/mm3, hemoglobin \< 8.0 g/dl, platelets \< 75 x 10\^3/l. * abnormal hepatic function evidenced by alt and ast value \>2.5 unl * subjects with any other malignant disease that can affect the bone. * subjects with any other non malignant disease that can jeopardize the evaluation of the primary objectives of this trial (severe osteoporosis) or that do not aloud perform the trial evaluations. * known hypersensibility to zoledronic acid or other bisphosphonates. * subjects that in the investigator's opinion can not cooperate with the protocol. other protocol inclusion/exclusion criteria may apply.

Keywords: prostate cancer zoledronic acid bone metastasis
immersive virtual reality exergaming program in adolescents diagnosed with juvenile idiopathic arthritis

Conditions: Juvenile Idiopathic Arthritis

Summary: the aim of the study is to investigate the effect of home-based exercise program versus personalized ivr exergame (fit-xr) program on physical fitness, functional capacity and physical activity in adolescents with juvenile idiopathic arthritis. patients followed up by four tertiary pediatric rheumatology centers will be included in the project. two different exercise programs will be applied to the patients by experienced physiotherapists. fit-xr program will be 25-30 minutes a day and will be applied 2 days a week for 8 weeks under the supervision of a physiotherapist in the clinic. the total points obtained by the participants during the fit-xr games will be recorded after each training session. in the second group, a personalized multicomponent (balance, strength, agility, endurance) home- based exercise program will be applied according to the physical fitness level of the children.


Eligibility criteria:
inclusion criteria: * having a definitive diagnosis of jia according to the ilar classification at least 6 months ago * being between the ages of 13-18 exclusion criteria: * jia diagnosis was made less than a month ago * having had a surgical or arthroscopic operation within the last year * presence of active synovitis or arthritis * have a disease that may limit the ability to exercise or increase the cardiovascular risk of exercise, including cardiovascular, pulmonary, musculoskeletal, or metabolic disorders * having active vestibular disease * having a neurological disease that prevents walking and exercising * having been exercising regularly for the last 6 months * having severe vision and hearing problems * use of any medication or supplement known to increase anabolic responses * having mental inability to understand the exercises

Keywords: exercise exergaming physical fitness