Kornimate/medical-research-clean huggingface dataset:
prognostic model heart failure

Conditions: Heart Failure Acute

Summary: this study aims to determine the prognosis of heart failure in our population by using multiple validated risk scores and to evaluate the strengths of these scores in assessing prognosis with better discrimination.

after fulfilling the eligibility criteria, informed consent will be obtained from all the patients regarding using data for research while maintaining anonymity. all the included patients will be interviewed by the assigned physician to complete the detailed questionnaire, including patient demographics, risk factors, and validated questionnaires including the acute decompensated heart failure national registry (adhere), the get with the guideline-heart failure (gwtg-hf) risk score, the ottawa heart failure risk scale (ohfrs), and ehmrg30-st score. all the patients will be followed after 30 days, and survival status will be obtained. the auc of the gwtg-hf risk score for all-cause death was 0.687 (95% ci, 0.649-0.725) \[18\], at 95% confidence interval, ±3% margin of error, the sample size was calculated to be n=626 patients. the calculated sample size was inflated by a factor of 1.5 for the design effect; hence, the sample size for the study will be n=939. for data verification, 10% of the data will be cross-checked with the source document (patient file).

Eligibility criteria:
inclusion criteria: * patients of age \> 18 years or more * either gender * patients visited the emergency department at nicvd, karachi * newly/already diagnosed with heart failure * giving informed consent * who can be followed in 30 days via telephone or in opd exclusion criteria: * patients of age \<18 years * patients who do not give consent * patients who are mentally handicapped due to any neurological or psychiatric illness (excluding depression/anxiety)
effect of high flow oxygen therapy in spontaneous breathing trial on weaning in mechanical ventilated patients

Conditions: Weaning; Mechanical Ventilation; Extubation

Summary: this clinical trial is aimed to show a spontaneous breathing trial using high flow oxygen therapy may lower weaning failure rate and reintubation rate than using t-piece.

we project to test the effect of high flow oxygen therapy in spontaneous breathing trial on weaning in mechanical ventilated patients. patients will be randomly assigned to undergo a spontaneous breathing trial in one of two ways: with a t-piece therapy or with high flow oxygen therapy. primary end-points are rate of weaning failure and rate of reintubation within 48 hr of extubation. weaning failure is defined as failed to spontaneous breathing trial or reintubation within 48 hr of extubation. secondary end-points are icu mortality, in-hospital mortality, icu length of stay, time to reintubation after extubation. study sample was calculated to detect ability of high flow oxygen therapy to reduce weaning failure from 42 to 15 percent, at two-tailed alpha error of 5% and power of 85% and 98 patients are needed in each arm.

Eligibility criteria:
inclusion criteria: * adult patients aged 18 years or more, both gender * receiving endotracheal intubation and mechanical ventilation for more than 12 hours * recovery from the precipitating illness * weaning readiness according to the following criteria : 1. respiratory criteria : 1. pao2:fio2 \>150 with fio2 ≤0.4, peep \<8 cm h2o 2. arterial ph \>7.35 3. rapid shallow breathing index (rsbi) \< 105 4. maximum inspiratory pressure (mip) \< -20 cm h20 2. clinical criteria : 1. absence of electrocardiographic signs of myocardial ischemia 2. no vasoactive drugs, or vital signs are stable with using vasoactive drugs 3. heart rate \<140/min, 4. hemoglobin \>8 g/dl 5. temperature \<38°c 6. no need for sedatives, or mental status are stable with sedatives 7. presence of respiratory stimulus, and appropriate spontaneous cough 8. absence of excessive tracheobronchial secretions exclusion criteria: * tracheostomy status * decision to stop life-supportive therapies before enrollment
adverse drug event prevention using structured pharmacist review

Conditions: Adverse Drug Reactions

Summary: the next four decades will see a marked expansion of the elderly population in ireland, in particular people aged over 80 yrs. persons aged over 80 are the highest consumers of prescription medicines in ireland and have the highest prevalence rates of major polypharmacy. polypharmacy is intimately linked with serious adverse drug events (ades) and consequent major morbidity and mortality. epidemiological data from the unites states indicate that ades is the fifth most common cause of death nationally. experts suggest that effective evidence based interventions can be applied to this major public health problem. a recently described approach to hospitalised older patients' medication optimisation is that of spinewine and colleagues at louvain university, belgium. in this model, a pharmacist with expertise in geriatric pharmacotherapy routinely reviews the prescriptions of older patients from admission to discharge. the pharmacist provides a detailed pharmaceutical care plan for older patients and their carers where appropriate as well as feedback information to prescribers in the event of detecting instances of probable medication inappropriateness. whenever an opportunity for medication optimisation is identified, the pharmacist discusses the opportunity with the prescriber who can accept or reject the intervention. at discharge from hospital, the pharmacist also provides written and verbal information on treatment changes to the patient / caregiver and gp. the intervention therefore represents a comprehensive pharmaceutical care approach that is based upon careful review and subsequent consensus on individualised pharmacotherapy. in an rct comparison of this approach with standard care, older patients in the intervention arm of the study had significant improvements in medication appropriateness (medication appropriateness index (mai), beers' criteria, and assessing care of vulnerable elders (acove) criteria.). expert pharmacist review of older peoples' medication in hospital is a proven intervention in term of reducing inappropriateness of medication.


Eligibility criteria:
inclusion criteria: * all patients aged 65 years and over presenting to cuh accident and emergency departments with acute illness for admission under a medical team will be eligible for the study. exclusion criteria: 1. age less than 65 years. 2. patient to be admitted under the care of a geriatrician psychiatrist of old age or clinical pharmacologist, or having been admitted under these services or attended their outpatient clinics in the previous 12 months. (these doctor groups are likely to minimise inappropriate medications in this population). 3. terminally ill patient attended by palliative care team. 4. critically ill patient e.g. admitted to intensive care unit. 5. patients who do not wish to participate in the study. 6. patients whose hospital physician does not wish to participate in the study ver, its efficacy in terms of ade prevention is not yet demonstrated.

Keywords: elderly hospital adverse drug pharmacist prevention
reducing urethral pain during urodynamic test - comparison between lidocaine gel and paraffin oil

Conditions: Pain

Summary: our purpose is to compare between intraurethral lidocaine gel and paraffin oil in reducing urethral pain during urodynamic test.

patients will be randomized into two groups: 1) lidocaine gel 2) paraffin oil. they will fill out 1 visual analogue scale (0-10) for urethral pain during the test.

Eligibility criteria:
inclusion criteria: * all men who will be referred for urodynamic test exclusion criteria: * active infection * permanent catheter

Keywords: urodynamic paraffin oil lidocaine gel pain
day to day variation of pressure pain threshold and muscle hardness

Conditions: Migraine Disorders; Tenderness, Muscle; Headache Disorders

Summary: the aim is to establish how headache and migraine can affect muscle hardness and tenderness in migraine patients

migraine is a very common disorder, and many migraine patients have symptoms from their neck and muscles. 50% of migraine patients have a sensation of stiff neck in relation to migraine attacks. furthermore it is well established, that migraine patients have tender muscles during migraine attack, which can be measured with pressure pain threshold. in this study the investigators aim to establish the variation in ultrasound elastography and pressure pain threshold in migraine patients over time. and establish the significance of headache, migraine and prodromes on these measurements. the study includes daily measurements of muscle hardness and muscle tenderness. the patients are asked to fulfill a headache diary and a short questionnaire asking about current headache, physical activity, stress and current infectious diseases. sleep and physical activity is also measured objectively using a fitbit charge2. furthermore the patients are asked about symptoms which often are associated with migraine (prodromes).

Eligibility criteria:
inclusion criteria: * migraine patient fulfilling international classification of headache disorders (ichd 3) criteria exclusion criteria: * regular medication use other than medication for migraine or headache * other pain disorders * musculoskeletal disorders affecting neck or upper body

Keywords: ultrasound elastography pressure pain threshold variation
medtronic symbiosis post-market registry for patients undergoing cardiac surgery

Conditions: Cardiovascular Diseases

Summary: the purpose of this observational, multi-center prospective, post-market registry is to confirm real-world device safety and performance, to ensure the continued acceptability of identified risks, and detect emerging risks.

the objective is to collect product safety and performance data for medtronic ce (conformitè europëenne )-marked cardiac surgery, including perfusion (cs) products. the main goals of this data collection are as follows: * identification of any (new) device-related complications including events which were not anticipated or documented in the instructions for use (ifu), or risk management plan, or clinical evidence evaluation report, or design failure modes and effect analysis * evaluation of device success defined as the absence of any probable or causal device-related adverse events or device deficiencies * evaluation of general device performance when applicable subjects are enrolled and, if applicable, followed according to routine care practices at their treating hospital. inclusion criteria: * subject or legally authorized representative provides written data release and/or informed consent per institution and/or geographical requirements prior to discharge from participating registry hospital. * subject will undergo or underwent a procedure in which an eligible medtronic cs product is/was used. exclusion criteria: • currently participating in an interventional drug or device study which may induce confounding factor(s) to the results from this registry data collection includes, for example: * demographics * product performance information * safety events

Eligibility criteria:
inclusion criteria: * subject or legally authorized representative provides written data release and/or informed consent per institution and/or geographical requirements prior to discharge from participating registry hospital. * subject will undergo or underwent a procedure in which an eligible medtronic cs product is/was used. exclusion criteria: * currently participating in an interventional drug or device study which may induce confounding factor(s) to the results from this registry
a program to reduce inappropriate medications among older adults with alzheimer's disease

Conditions: Alzheimer Disease

Summary: potentially inappropriate prescribing includes the use of medications that may no longer be necessary or that may increase the risk of harm. inappropriate prescribing can increase the overall symptom burden, and negatively affect health-related quality of life and function. the inappropriate prescription of certain drug categories such as sedative/hypnotics, antipsychotics, and strong anticholinergic agents poses particular risks for older adults, and may be more common among those with alzheimer's disease and alzheimer's disease- related dementias (ad/adrd) due to a higher prevalence of multimorbidity and more frequent prescription of five or more medications. the d-prescribe-ad (developing a program to educate and sensitize caregivers to reduce the inappropriate prescription burden in elderly with alzheimer's disease) study will test a health plan-based intervention using the nih collaboratory's distributed research network, which employs the food and drug administration (fda) sentinel system infrastructure. the overarching goal of this randomized controlled trial is to assess the effect of a patient/caregiver- centered, multifaceted educational intervention on potentially inappropriate prescribing in patients with ad/adrd. the research hypothesis is that education on inappropriate prescribing among patients/caregivers and their providers can reduce medication-related morbidity in patients with ad/adrd and improve medication safety for this vulnerable population. the study population will include community-dwelling patients with ad/adrd, identified based on diagnoses codes of ad/adrd or use of a medication for alzheimer's disease, who have evidence of potentially inappropriate prescribing the three drug classes above. the trial will evaluate the effect of educational interventions designed to spur patient/caregiver-provider communication about medication safety (versus usual care) on the proportion of patients with inappropriate prescribing, the primary outcome of this study. the trial will be conducted in two large, national health plans.


Eligibility criteria:
patient inclusion criteria: 1. diagnosis of ad/adrd based on a combination of ad/adrd codes or treatment with a pharmacologic therapy used for ad (e.g., donepezil, rivastigmine, galantamine, and memantine) in the 365 days prior to or on cohort entry date. 2. evidence of potentially inappropriate prescribing with antipsychotics, sedative-hypnotics, and strong anticholinergics within the past 3 months 3. age ≥50 years of age as of cohort entry date 4. continuous medical and pharmacy insurance coverage for at least the prior year patient exclusion criteria: 1. evidence of residing in a nursing home or skilled nursing facility or receiving palliative care. 2. incomplete/missing prescriber id or incomplete contact information for either patient or prescribing provider. 3. on "do not contact" list

Keywords: deprescribing dementia medication safety
transvaginal ultrasonography guided embryo transfer

Conditions: Infertility, Female

Summary: to evaluate the value of using transvaginal ultrasound guided embryo transfer in obese patients undergoing in vitro fertilization.

the 800 participants with body mass index more than 30kg/m2 were randomly allocated to two groups of equal size using an automated web-based randomization system. the first group 400 patient undergoing the transabdominal-guided embryo transfer, the second group 400 patient undergoing transvaginal-guided embryo transfer.

Eligibility criteria:
inclusion criteria: * bmi more than 35, good ovarian reserve, unexplained infertility more than 3 years. exclusion criteria: * severe male factor of infertility,uterine factor of infertility excluded by ultrasonography and hysteroscopy ,ovarian endometrioma or patients with poly cystic ovary syndrome, obesity caused by abnormal endocrine function (thyroid or adrenal disorder)

Keywords: obesity embryo transfer invitro fertilization
efficacy and safety of everolimus (rad001) in patients of all ages with subependymal giant cell astrocytoma associated with tuberous sclerosis complex (tsc)(exist-1)

Conditions: Tuberous Sclerosis; Subependymal Giant Cell Astrocytoma

Summary: this study evaluated the efficacy and safety of everolimus in treating patients with subependymal giant cell astrocytomas associated with tuberous sclerosis complex.


Eligibility criteria:
inclusion criteria: * all ages * definite diagnosis of tuberous sclerosis according to the modified gomez criteria * at least one subependymal giant cell astrocytoma of at least 1 cm in diameter * evidence of sega worsening as compared to prior mri scans * females of child bearing potential must use birth control * written informed consent exclusion criteria: * sega related surgery is likely to be required in the opinion of the investigator * recent heart attack, cardiac related chest pain or stroke * severely impaired lung function * severe liver dysfunction * severe kidney dysfunction * pregnancy or breast feeding * current infection * history of organ transplant * surgery within two months prior to study enrollment * prior therapy with a medication in the same class as everolimus * uncontrolled high cholesterol * uncontrolled diabetes * hiv * patients with metal implants thus prohibiting mri evaluations other protocol-defined inclusion/exclusion criteria may apply

Keywords: sega tuberous sclerosis subependymal giant cell astrocytoma mtor rad001 mamalian target rapamycin everolimus tsc
a phase 2b study of inhaled rvt-1601 for the treatment of persistent cough in ipf

Conditions: Persistent Cough in IPF; Chronic Cough; IPF

Summary: idiopathic pulmonary fibrosis (ipf) is a rare, progressive life-threatening disease that is characterized by exertional dyspnea and persistent dry cough. cough in ipf is both a presenting and a complicating clinical feature, which affects approximately three quarters of ipf cases. it is often a debilitating symptom that adversely affects quality of life (qol) and is usually refractory to medical therapy. inhaled rvt-1601 (formerly, pa101b), a new inhalation formulation of cromolyn sodium delivered via the eflow® closed system (cs) nebulizer, is being evaluated in this phase 2b study for the treatment of persistent cough in patients with ipf.


Eligibility criteria:
inclusion criteria: * male or female subjects age 40 through 89 years * confirmed diagnosis of ipf with clinical features consistent with the current clinical practice guidelines * persistent cough for at least 8 weeks that is primarily due to ipf and not responsive to anti-tussive therapy * daytime cough severity score of ≥ 40 mm on a 100-mm vas * 24-hour average cough count of at least 10 coughs per hour * forced vital capacity (fvc) \> 45% predicted value within 4 weeks * diffusion capacity for carbon monoxide corrected for hemoglobin (dlcoc) \> 30% predicted value within 4 weeks * life expectancy of at least 12 months exclusion criteria: * current or recent history of clinically significant medical condition, laboratory abnormality, or illness that could place the subject at risk or compromise the quality of the study data * significant coronary artery disease (i.e., myocardial infarction within 6 months or unstable angina within 1 month) * upper or lower respiratory tract infection within 4 weeks * acute exacerbation of ipf within 6 months * lung transplantation expected within 12 months * requiring supplemental o2 \> 4 litres/min to maintain peripheral arterial o2 saturation (spo2) \> 88% at rest * history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 2 years * current smoker (i.e., use of tobacco products within the last 3 months) * current or recent history of drug or alcohol abuse within 12 months * participation in any other investigational drug study within 4 weeks * use of certain drugs for cough management within 4 weeks: prednisone, opiates, baclofen, gabapentin, pregabalin, thalidomide, amitriptyline, inhaled corticosteroids, or inhaled bronchodilators * use of ace inhibitors or cromolyn sodium within 4 weeks * females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable means of birth control during the study * history of hypersensitivity or intolerance to cromolyn sodium

Keywords: cough chronic cough ipf ipf cough
a safety and activity study of sbt6050 in combination with other her2-directed therapies for her2-positive cancers

Conditions: HER2-positive Breast Cancer; HER2-positive Gastric Cancer; HER2-positive Colorectal Cancer; HER2-expressing Non-small Cell Lung Cancer

Summary: this study is designed to assess the safety and preliminary activity of sbt6050 in combination with trastuzumab deruxtecan (part 1) or tucatinib plus trastuzumab +/- capecitabine (part 2). participants will be enrolled into each arm based on cancer diagnosis and prior therapies.


Eligibility criteria:
inclusion criteria: * advanced or metastatic her2-expressing (ihc 2+ or 3+) or her2-amplified solid tumors * measurable disease per the the response evaluation criteria in solid tumors (recist) version 1.1 criteria * tumor lesion amenable for biopsy or able to submit an adequate recent archived tumor tissue for baseline testing, as follows: 1. breast cancer and colorectal cancer (crc): archival biopsy tissue obtained after the last her2-directed therapy (excluding trastuzumab and pertuzumab), or a fresh biopsy 2. gastric cancer and non-small-cell lung cancer (nsclc): archival biopsy tissue taken within the past 12 months and after completion of last her2-directed therapy, or a fresh biopsy * ecog performance status of 0 or 1 * adequate hematologic, hepatic, renal, and cardiac function exclusion criteria: * history of allergic reactions to certain components of study treatment therapies * untreated brain metastases * currently active (or history of) autoimmune disease * taking the equivalent of \>10 mg / day of prednisone * taking a medication that moderately induces cyp2c, strongly inhibits cyp2c8, or interacts with both enzymes (cyp3a and cyp2c8) * uncontrolled or clinically significant interstitial lung disease (ild) / pneumonitis that requires systemic corticosteroid treatment or suspected ild / pneumonitis * hiv infection, active hepatitis b or hepatitis c infection

Keywords: sbt6050 her2 breast cancer gastric cancer colorectal cancer non-small cell lung cancer tlr8 trastuzumab deruxtecan tucatinib trastuzumab capecitabine
safety and efficacy of pomalidomide, bortezomib and low-dose dexamethasone in subjects with relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. this study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone.


Eligibility criteria:
inclusion criteria: * must be ≥ 18 years at the time of signing informed consent. * must have documented diagnosis of multiple myeloma and have measureable disease by serum and urine protein electrophoresis. * must have had at least 1 but no greater than 3 prior anti-myeloma regimens. * must have documented disease progression during or after their last anti-myeloma therapy. * all subjects must have received prior treatment with a lenalidomide containing regimen for at least 2 consecutive cycles. exclusion criteria: * documented progressive disease during therapy or within 60 days of the last dose of a bortezomib-containing therapy under the 1.3 mg/m\^2 dose twice weekly dosing schedule. * peripheral neuropathy grade 3, grade 4 or grade 2 with pain within 14 days prior to randomization. * non-secretory multiple myeloma. * subjects with severe renal impairment requiring dialysis. * previous therapy with pomalidomide.

Keywords: multiple myeloma pomalidomide