Kornimate/medical-research-clean huggingface dataset:
rayaldee non interventional study (nis) on effectiveness in nd-ckd shpt patients

Conditions: Chronic Kidney Disease

Summary: the overall study objective is to collect real-world data on the safety and effectiveness of erc to gradually increase 25d to the level required by stage 3 and 4 ckd patients. erc (rayaldee), a prolonged-release calcifediol (prc) formulation, is an orally administered prohormone of active vitamin d (1,25-dihydroxyvitamin d (1,25d)) designed to increase serum total 25d safely and to a high enough magnitude to reliably reduce elevated pth in patients with non-dialysis chronic kidney disease (nd-ckd). clinical studies show that erc is an effective, well tolerated treatment for secondary hyperparathyroidism (shpt) in nd-ckd patients with vitamin d insufficiency or deficiency. erc gradually raises serum 25d levels, resulting in physiologically regulated increases in serum 1,25d and sustained and progressive reductions in pth levels, while avoiding clinically meaningful increases in serum phosphate and calcium. to date, experience with the use of erc results exclusively from patients from the us and mainly from patients who have participated in clinical trials. it is therefore of major interest to observe the value of erc in daily use outside of the controlled trial settings in the us as well as in europe. (protocol v.2.0,06dec2023).

non-interventional, prospective, multicentre, cohort study. approximately 100 patients diagnosed with nd-ckd with shpt being treated with erc according to the smpc will be included. the scheduled total study duration is 2.5 years, with a recruitment phase of approximately 1.5 years. the individual prospective observational period per patient is scheduled to last up to 12 months, or up to 18 months for pre-treated patients. the number of observational time points for an individual patient will be dependent on the individual observational period and is assumed to be approximately every 3 months. a patient is eligible if erc treatment initiation can coincide with the date of patient inclusion in the study or can happen up to 6 months before patient inclusion in the study. the observational period of erc treatment will be retrospective if it occurs before study inclusion and prospective for the period after study inclusion. the decision to initiate treatment remains with the treating physician, in line with their normal standard of care, in accordance with the smpc.

Eligibility criteria:
inclusion criteria: * signed informed consent * age ≥18 years * indication for erc treatment in accordance with the currently approved smpc. * starting erc treatment or being on erc treatment for a maximum of 6 months before inclusion in the study. * stable kidney function in the medical judgment of the investigator exclusion criteria: parallel participation in an interventional study • enrolment in a prior clinical trial with erc

Keywords: hyperparathyroidism calcifediol
quadruple therapy versus dual therapy as rescue regimens for helicobacter pylori infection

Conditions: Rescue Therapy for Helicobacter Pylori

Summary: the eradication rates of first-line treatment for helicobacter pylori(hp) infection are not satisfactory. the study aims to compare the efficacy and safety between quadruple therapy with furazolidone and dual therapy with high doses of amoxicillin as rescue regimens for hp.


Eligibility criteria:
inclusion criteria: * patients aged from 18 to 80 years, who presented with upper gastrointestinal symptoms and endoscopically proven h. pylori-positive non-ulcer dyspepsia, were recruited into the study. exclusion criteria: * patients with peptic ulcer, * previous h. pylori eradication treatment, * previous gastric surgery, * pregnancy, * lactation, * major systemic diseases, * receipt of anti-secretory therapy, * antibiotics or bismuth in the preceding four weeks, or - allergy to any one of the medications in the regimen.

Keywords: helicobacter pylori, rescue, quadruple therapy，dual therapy
dyadic yoga intervention for the improvement of healthcare utilization and quality of life in patients with head and neck cancer undergoing chemoradiation and their caregivers

Conditions: Head and Neck Carcinoma

Summary: this study evaluates if partner-based (dyadic) yoga programs may improve the quality of life of patients with head and neck cancer undergoing chemoradiation and their caregivers, and if it is a cost-effective option. yoga programs may decrease how often patients come to the hospital during and after treatment with chemoradiation, and improve the quality of life for both patients and caregivers.

primary objectives: i. examine the efficacy of the dyadic yoga (dy) intervention regarding reduced patient emergency department (ed) visits and feeding tube (ft) insertions and improved patient and caregiver quality of life (qol) as compared to the usual care (uc) group. ii. estimate intervention costs, direct medical costs, indirect costs (i.e., productivity loss), and evaluate the overall cost-effectiveness of the dy intervention for patients and caregivers. iii. demonstrate that, compared to the uc group, the dy program improves patient and caregiver symptoms burden, objective physical function, and illness communication and reduces patient use of opioids during chemoradiotherapy (crt), which will in turn mediate intervention outcomes at the follow-up assessments. iv. understand the patient and caregiver experience of head and neck cancer (hnc), healthcare utilization and symptom management and emerging themes as possible mediators as they relate to or suggest modifications of our proposed model using qualitative methods. outline: participants are randomized to 1 of 2 arms. arm i: patients and caregivers receive standard care including education pertaining to symptom management, prophylactic dental hygiene and possible extraction, speech pathology for baseline swallowing assessment and prophylactic treatment, and dietary services for regular nutrition consults during crt. psychiatry, social work, interventional radiology and supportive care services are consulted as needed. arm ii: patients and caregivers receive standard care as in arm i. patients and caregivers also participate in yoga sessions 3 times per week over 60 minutes each for a total of 15 sessions. after completion of study, participants are followed up every 2 weeks for 3 months and then monthly for up to 6 months.

Eligibility criteria:
inclusion criteria: * patients: diagnosed with a primary hnc and going to receive at least 5 weeks (25 fractions) of crt * patients: eastern cooperative oncology group (ecog) performance status of =\< 2 * patients: having a family caregiver (e.g., spouse/partner, sibling, adult child) willing to participate * patients and caregivers: must be at least 18 years old * patients and caregivers: able to read and speak english * patients and caregivers: able to provide informed consent exclusion criteria: * patients and caregivers: who have regularly (self-defined) participated in a yoga program in the year prior to diagnosis
ultrasonographic predictors of hypotension after induction

Conditions: General Anesthesia; Hypotension on Induction

Summary: the purpose of the study is to evaluate the predictive value of the inferior vena cava collapsibility index and caval aorta index for detecting hypotension after induction of general anesthesia.

since cardiovascular depressant and vasodilatory effects of anesthetic agents, patients may be at risk of hypotension after induction of general anesthesia. previous studies reported that, for evaluating volume status, some ultrasonographic measurements such as inferior vena cava collapsibility index (ivcci) could be used. also some studies stated that measurement of aorta diameter index (ivc : ao index) is reliable to predict hypotension after induction of spinal anesthesia. at the study, the investigators aimed to investigate the predictive values of the inferior vena cava collapsibility index and caval aorta index under ultrasound guidance in predicting post-induction hypotension in patients under general anesthesia.

Eligibility criteria:
inclusion criteria: * patients more than 18 years of age * american society of anesthesiologists' (asa) physical status 1 or 2 exclusion criteria: * bmi more than 30 kg/m² * use of angiotensin converting enzyme inhibitors * pregnancy, * emergency operations * baseline arterial systolic blood pressure less than 90 mmhg * mean arterial blood pressure less than 70 mmhg
monitoring serologic response to severe acute respiratory syndrome-2 (sars-cov-2)/covid-19 in children

Conditions: COVID-19; SARS-CoV-2; Inflammatory Bowel Diseases

Summary: individuals susceptible to sars-cov-2 and the illness it causes (covid-19) are comprised of heterogeneous populations with a large risk spectrum for more severe disease. pre-existing risk factors for a more severe course include respiratory and cardiovascular disease, morbid obesity, diabetes, underlying kidney or liver disease, and immunocompromised status. whether children and young adults with inflammatory bowel disease (ibd) or juvenile idiopathic arthritis (jia) receiving immunomodulating biologic and other therapies which are known to increase risk of viral infection are at increased risk of complications from covid-19 or post-infectious co-morbidities, including the recently described multi inflammatory syndrome (misc), is entirely unclear. this research focuses on the heretofore uncharacterized immune response to sars-cov-2 infection in children and young adults with ibd or jia who are receiving maintenance immunosuppressive biologic therapies. given the large connecticut based infusion program, in a region of the united states with a recent large outbreak of covid-19, the investigators have a unique opportunity to address a glaring knowledge gap in this unique pediatric, adolescent, and young adult population. the investigators will longitudinally determine antibody development and durability to sars-cov-2 in approximately 450-500 children and young adults with ibd or jia receiving biologic therapy using a highly sensitive and specific quantitative assay utilizing novel technology. this period will include a return to school or work for many with likely resurgent infections, as well as the possible introduction of anti-sars cov-2 vaccines. the specific aim is to study the acute and convalescent antibody responses to sars-cov-2 infection in a cohort of children and young adults receiving infusions of biologic therapies for ibd and jia.


Eligibility criteria:
inclusion criteria: 1. patients aged 2 to 27 years inclusive 2. patients receiving biologic infusions for inflammatory or rheumatologic disorders at the connecticut children's infusion center, at a minimum frequency of 2 infusions over a 4 month period 3. consent/assent as indicated 4. have vein access placement as standard of care exclusion criteria: 1. patient and/or parent/legal guardian refused participation 2. inability to draw requisite blood sample for serum collection

Keywords: covid-19 serological testing
patient-centered care survey

Conditions: Infertility

Summary: the key to patient-centered care is to identify what the patient perceives as meaningful. the primary objective of this research is to evaluate which aspects of patient-centered care are priorities to infertility patients, and if those priorities vary by geographical region.

an electronic survey will be distributed to current patients within the prelude network, a network of fertility practices, for a total of six months. survey responses will be collected anonymously using survey monkey. the survey is designed to collect information on patient preferences for patient-centered care. participants will rank the importance of the different options within each factor category (clinic, physician, finance, and staff). in addition, demographic questions are included and will be utilized to determine if these factors could have a significant impact on patient-centered care preferences. it is anticipated that at least 1,000 completed surveys will be collected. a similar survey was distributed to prelude network physicians. patient and physician responses may be compared as part of additional data analysis.

Eligibility criteria:
inclusion criteria: * current patient within the prelude network (a network of fertility clinics). * has had any type of visit at a participating clinic within the last 6 months of the date of study initiation. exclusion criteria: * not a current patient at a participating clinic. * has not had an appointment within 6 months of the date of study initiation.

Keywords: patient-centered care patient experience
early limb rehabilitation therapy within 48 h of acute stroke onset(ertas)

Conditions: Time of First Rehabilitation Therapy

Summary: this study aimed to evaluate effectiveness of initial limb rehabilitation compare therapy took place within 48h with therapy took place after 48h for patients with stroke (modified rankin scale score 3-4).

early rehabilitation after stroke is thought to contribute to the effects of stroke-unit care. however, time of initial rehabilitation therapy is poorly defined and not underpinned by strong evidence in patients with stroke (modified rankin scale score 3-4). the investigators do this parallel-group, single-blind, randomized controlled trial in shengjing hospital of china medical university. participants (aged≥18 years) with ischaemic or haemorrhagic stroke, first or recurrent, who meet physiological criteria are randomly assigned (1:1), to receive usual stroke therapy. treatment with recombinant tissue plasminogen activator is allowed. randomisation is stratified by study site and stroke severity. the primary outcome was a outcome 3 months after stroke, defined as a modified rankin scale score of 3-4. the investigators do analysis on an intention-to-treat basis.

Eligibility criteria:
inclusion criteria: 1. patients were diagnosed acute stroke within 24h onset. head ct or mri scans were confirmed the diagnosed. 2. the age was from 18 to 75 years old. 3. temperature ≤38.0℃，pulse rate 60-100bpm，respiratory rate≤24 bpm，systolic blood pressure≤220mmhg. 4. glasgow score: 9-14. 5. acute physiology and chronic health evaluation(apache ⅱ)score: ≤17. 6. national institutes of health stroke scale (nihss)score: \<16. (upper and lower extremity motor function item score\<8). 7. modified rankin scale score:3-4. 8. there were no serious diseases before, such as heart, liver, kidney and lung diseases. 9. patients themselves or their nominated representative sign the informed consent form. exclusion criteria: 1. there were unstable vital sign. there were serious organic dysfunction (heart, liver, kidney or lung). 2. patients with transient ischemic attack. 3. patients with subarachnoid haemorrhage. 4. patients with haemorrhage were documented immediate surgery. 5. pregnancy patients with stroke. 6. during the course of the project, major diseases took place (such as, myocardial infarction, gastrointestinal bleeding, respiratory failure, pulmonary embolism, deep vein thrombosis).
efficacy and safety of lu aa39959 in patients with bipolar depression

Conditions: Bipolar Disorder

Summary: this study will evaluate the efficacy and safety of lu aa39959 in the treatment of depression in patients with bipolar disorder.

bipolar disorder is a common lifelong psychiatric disorder characterized by recurrent mood swings with manic or hypomanic episodes alternated with depressive episodes of longer duration. patients spend more time in depression than in (hypo)mania over their life time. the main goals for the treatment of bipolar disorder are resolution of symptoms, return to premorbid level of social functioning and prevention of future episodes. although there are many treatments for bipolar disorder, few are approved, and they have limitations in their use due to safety and tolerability issues. recommendations exist to use mood stabilisers, antipsychotics or a combination thereof with or without antidepressants and the polypharmacy employed in many cases is a reason for concern. there is a major medical need for more effective treatments in monotherapy with a reduced potential for adverse effects. this study evaluates the efficacy and safety of the new drug, lu aa39959, in treatment of depression in patients with bipolar disorder.

Eligibility criteria:
patients suffering from a major depressive episode of bipolar ii or i disorder, according to dsm-iv tr inclusion criteria: * current major depressive episode of bipolar ii or i disorder, according to dsm-iv tr * moderate to severe depression * history of at least one documented mania or hypomania episode * absence of current mania or hypomania exclusion criteria: * any current psychiatric disorder other than bipolar disorder defined in the dsm-iv tr * any substance disorder with the previous 6 months * use of any psychoactive medication (including mood stabilizers) within 2 weeks before randomisation and during the study * ect within 6 months before the study * female of childbearing potential and not using adequate contraception * other protocol-defined inclusion and exclusion criteria may apply

Keywords: depression bipolar i disorder bipolar ii disorder placebo-controlled double-blind randomised controlled multicenter clinical study mania
paclitaxel/carboplatin (pc) followed by gefitinib versus pc in advanced non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: this study compares paclitaxel/carboplatin (pc) to pc chemotherapy followed by gefitinib for 2 weeks in patients with non-small cell lung cancer (nsclc) without epidermal growth factor receptor (egfr) mutations. expanded acronym : \[p\]aclitaxel/ca\[r\]boplatin (pc) followed by gef\[i\]tinib in a\[d\]vanc\[e\]d non-small cell lung cancer (nsclc): randomized phase ii study.

a randomized phase ii trial that compares paclitaxel/carboplatin (pc) to pc chemotherapy followed by gefitinib for 2 weeks in patients with nsclc without egfr mutations. while previous studies with cytotoxic agents and gefitinib failed to show any benefit, we altered the schedule of administration in hopes to gain synergy between agents.

Eligibility criteria:
inclusion criteria: * more than 18 years of age * histologically documented non-small cell lung cancer with metastasis (stage iv) or locally advanced (stage iiib) with malignant effusion. * at least 1 measurable lesion as defined by recist1.0. all target lesions must have a unidirectional diameter of at least 1cm. baseline measurements must be compared within 4 weeks prior to enrollment. * ecog ps 0-2 * at least 1 week since the last radiotherapy. patients must have recovered from all acute toxicities from radiotherapy. * patients must have adequate hematologic, renal and liver function as defined by hb \> 9g/dl, neutrophils \> 1000/mm3, platelets \> 50,000/mm3, creatinine \< 2mg/dl, and ast (sgot) and/or alt (sgpt) \< 5 x unl (upper normal limit). * willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures. * written and voluntary informed consent understood, signed and dated. exclusion criteria: * patients with tumor harboring egfr mutation. * prior systemic therapy for nsclc * non-smoking patients with adenocarcinoma. but if those patients show wild type egfr, they are eligible to this study. * symptomatic brain metastasis. brain metastases stable \< 2 weeks before dosing or requiring concurrent steroid treatment or with clinical symptoms. * major surgery within 3 weeks prior to study enrollment. * previous (less than 3 years ago) or current malignancies at sites other than curatively treated in situ carcinoma of cervix, or basal or squamous cell carcinoma of the skin. * severe medical illness or active infection that would impair the ability to receive gefitinib. * pregnancy or breast feeding.
intervention to promote weight loss in latinas at-risk for diabetes

Conditions: Diabetes

Summary: the overarching goal of this project is to develop and test a behavioral intervention delivered by promotoras to help at-risk latinas lose weight and prevent diabetes.

the goal of the proposed research is to compare two evidence-based strategies for preventing type 2 diabetes - promotora-led lifestyle intervention and metformin - vs. usual care (uc) among latinas in a "real world" setting. the aims of this study are to 1) develop a protocol-based, promotora-led lifestyle intervention (pli) to promote weight loss in at-risk latinas, and assess its feasibility; 2) compare changes in weight and cardiometabolic markers-hemoglobin a1c, fasting lipids, blood pressure-from baseline to 1 year between at-risk latinas randomly assigned to the pli group versus metformin and usual care (uc) groups; and 3) understand the social and cultural context surrounding weight-related behaviors among latinas at-risk for diabetes. the investigators hypothesize that latinas assigned to pli and metformin will have greater weight loss (primary outcome) and greater improvements in cardiometabolic markers from baseline to 1 year than those randomized to uc

Eligibility criteria:
inclusion criteria: * female gender * latino ethnicity * spanish fluency * age ≥20 years * bmi ≥25 kg/m2 * and "increased risk of diabetes" (ada diabetes risk score ≥4 as determine by 7-item questionnaire and hemoglobin a1c ≥ 5.6%) exclusion criteria: * hemoglobin a1c ≥ 6.5% * current or planned pregnancy during the study period * chronic conditions that could affect potential participants' ability to participate (osteoarthritis, heart disease, pulmonary disease requiring oxygen or daily bronchodilator use, and severe psychiatric disease) * medical comorbidities that could influence weight loss or weight gain (thyroid disease, cancer, and hiv) * medications that could affect weight or glucose metabolism (thiazide diuretics, β-blockers, and systemic glucocorticoids).