Kornimate/medical-research-clean huggingface dataset:
study to evaluate the safety and efficacy of iv infusion treatment with omecamtiv mecarbil in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure (atomic-ahf)

Conditions: Heart Failure

Summary: the primary objective of the study is to evaluate the effect of 48 hours of intravenous (iv) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure. this is a multicenter, randomized, double-blind, placebo-controlled study with 3 dose cohorts enrolled sequentially in order of ascending dose strength of omecamtiv mecarbil. in each cohort, subjects are randomized 1:1 to omecamtiv mecarbil or placebo.

this study was conducted by amgen as the ind holder, with cytokinetics as a collaborator. due to the termination of the collaboration agreement between amgen and cytokinetics in may 2021 and subsequent transfer of the omecamtiv mecarbil ind from amgen to cytokinetics, cytokinetics is now listed as the sponsor.

Eligibility criteria:
inclusion criteria: * male or female 18 - 85 years * hospitalized for worsening heart failure, within 24 hours of initiating iv loop diuretic * dyspnea due to heart failure, at rest or with minimal exertion * history of left ventricular ejection fraction (lvef) ≤ 40% * elevated brain natriuretic peptide (bnp) or n-terminal fragment bnp (nt-probnp) exclusion criteria: * receiving iv vasopressor (excluding low dopamine), inotropic or mechanical support * acute coronary syndrome (acs) * within 30 days prior to enrollment: cardiac resynchronization therapy (crt) or implantable cardioverter defibrillator (icd) implantation, acs, coronary revascularization, transient ischemic attack (tia) or stroke, sustained ventricular arrhythmia, or major surgery * severe valvular stenosis, hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease * estimated glomerular filtration rate (egfr) \< 20 ml/min/1.73m2

Keywords: intravenous iv left ventricular systolic dysfunction hospitalized acute heart failure heart failure left ventricular ejection fraction pharmacokinetics pharmacodynamics dyspnea hospitalization in-patient omecamtiv mecarbil double-blind randomized placebo-controlled
hypoxic red blood cells in sickle cell anemia

Conditions: Sickle Cell Anaemia; Sickle Cell Anemia Crisis; Sickle Cell Anemia in Children; Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)

Summary: the overall objective of this study is to evaluate the effectiveness and safety of transfusing hypoxic red blood cells manufactured with the hemanext one system in patients with sickle cell anemia. the hemanext one device was cleared through the de novo process in september 2023.

in this direct-to-phase ii study, hemanext inc. will carry out a prospective, multi-center, single-blind, randomized, cross-over study in patients with sickle cell anemia, comparing the efficacy of transfusion of hypoxic red blood cells (hrbcs) to transfusions with conventional rbcs. the primary efficacy objective is to demonstrate an increase in %hba between red cell exchange transfusions (rce) of hrbcs compared to conventional rbcs. the increases in %hba (normal hb) from rce will be accompanied by a concomitant decrease in sickle hb (%hbs). the persistence of %hba will allow for a decrease in the volume of rbcs transfused with an overall decrease in the number of units consumed, which in turn can result in an increase in time (number of days) between transfusions.

Eligibility criteria:
inclusion criteria: 1. male or female at least 7 years of age; 2. are able to provide informed consent, and assent as applicable, to participate in the study; 3. diagnosis of sickle cell anemia (sca) (hbss, hbsβ0 thalassemia) with participation in a chronic transfusion program and have undergone regular transfusions during at least 6 months prior to screening; 4. have had an average interval of at least 14 days between rbc transfusions over the past 6 months; 5. if on iron chelation therapy, have been on a stable dose for ≥3 months prior to screening; exclusion criteria: 1. are not exclusively transfused at the site; 2. have a diagnosis of hbsc disease, hbsβ+ thalassemia or another scd variant (excluding hbss and hbsβ0 thalassemia) 3. are routinely transfused with washed, packed rbc units; 4. have received hemoglobin inducers (e.g. erythropoietin) in the 30 days prior to screening; 5. are currently being evaluated for gene therapy; 6. have any clinically significant pulmonary, cardiovascular, endocrine, hepatic, gastrointestinal, renal, infectious, immunological (including significant allo- or auto-immunization) disease, considered not adequately controlled prior to the study; 7. are a female of child-bearing potential who is pregnant or planning to become pregnant in the next 14 months; 8. have a history of allo-immunization that cannot be managed by the local blood bank; 9. patients who, in the opinion of the investigator, would not be able or willing to comply with the protocol; 10. is a ward of the state, prisoner, or transient
efficacy and safety evaluation of acupoint application in the treatment of knee osteoarthritis joint pain

Conditions: Knee Osteoarthritis

Summary: to evaluate the efficacy and safety of acupoint application of traditional chinese medicine in the treatment of koa joint pain through a prospective, randomized, double-blind, placebo-controlled clinical study.


Eligibility criteria:
inclusion criteria: 1. western medicine diagnosed as knee osteoarthritis, clinical classification is primary, and conforms to the tcm syndrome of cold and wet obstruction; 2. guidelines for the diagnosis and treatment of osteoarthritis 2018 criteria and kellgren -lawrence\<ⅲ; 3. vas pain score ≥40mm (select the limb with the most obvious pain symptom); 4. for patients taking nonsteroidal drugs or other disease-improving drugs (such as cartilage protectants), the dose has been stable for at least 4 weeks; 5. signed informed consent. exclusion criteria: 1. patients who underwent intra-articular therapy within 3 months prior to the trial or required relevant surgical treatment within 1 year； 2. glucocorticoid and joint cavity injection were used 4 weeks before treatment; 3. swelling and heat of knee joint; 4. other diseases causing knee pain; such as acute joint injury, tuberculous arthritis, rheumatoid arthritis, rheumatoid arthritis, suppurative arthritis, osteomyelitis, psoriatic arthritis, gout, villi nodular synovitis. 5. history or evidence of any of the following diseases during the screening period: serious cardiovascular and cerebrovascular diseases, active or recurrent ulcer of digestive system or other diseases at risk of bleeding, other serious diseases of digestive system, combined with malignant tumor, serious or progressive diseases of blood system or other systems. 6. patients with other mental diseases who are unable to cooperate or unwilling to cooperate. 7. before screening, any of the laboratory test indicators met the following criteria: alt and ast \> 1.5 times the upper limit of normal value, cr \> 1.2 times the upper limit of normal value, and other clinically significant laboratory test abnormalities, which were determined by the investigator to be unsuitable for inclusion in the group. 8. allergic constitution or allergic to test drugs, excipients or similar ingredients. 9. suspected or confirmed history of alcohol or drug abuse; 10. pregnant or lactating women or those who have planned pregnancy recently and do not want to use contraception; 11. participants in other clinical trials within 3 months prior to enrollment; 12. the investigator considered that the patients should not participate in the clinical trial.other requirements for inclusion are willingness to participate for the duration of the trial. all patients will receive verbal and written information about the trial and sign a consent form before inclusion. the researcher obtains written consent before inclusion and randomisation.
long-term benefit in chronic hepatitis b patients after standard peginterferon alfa therapy

Conditions: Hepatitis B

Summary: in this cohort study, patients with chronic hepatitis b who prior participated in tb1211ifn study and received at least 39 doses of peginterferon alfa will be enrolled. hbsag/anti-hbs level, hbeag/anti-hbe level, serum hbv dna load and alanine transaminase level will be test every year from the second year to the fifth year after the ending of peginterferon alfa treatment, and long-term benefit of interferon treatment will be evaluated.


Eligibility criteria:
inclusion criteria: * understand and sign the informed consent form. * participated in nct01760122 study (tb1211ifn) and has received at least 39 doses of peginterferon. exclusion criteria: * conditions which in the opinion of the investigator should be precluded from the study(e.g., poor compliance).

Keywords: peginterferon alpha hbeag seroconversion immune control
pilot: group therapy for children who stammer

Conditions: Stammering

Summary: the aim of the study is to answer the question: is a large-scale research study of the effectiveness of group speech and language therapy (salt) for young people who stammer possible? the study will look at the issues involved in setting up a large-scale investigation of treatment for young people who stammer. it will inform the investigators whether larger studies would be possible and give some early-stage information on the effectiveness of group salt for these young people. the findings will pave the way for building and testing out treatment programmes where there will be clear positive benefit for young people who stammer and their families. to answer the research question, the study will tell the investigators (a) how easy/difficult it was to get people to take part, (b) young people and parents'/carers' views on taking part and (c) whether the assessments were able to pick up changes in speech and attitudes towards stammering reported by the young people and their carers. sufficient numbers of participants were not recruited to carry out the intended rehearsal pilot rct study design.


Eligibility criteria:
inclusion criteria: * aged between 8;0 years and 15;11 years at 20.07.09 * currently in treatment, on review or on waiting list for treatment. * has had an initial nhs speech and language therapy assessment by newcastle, northumberland or north tyneside speech and language therapy service. * has a diagnosis of stammering. * has sufficient understanding of spoken (english) language to score at or above the 16th percentile on the understanding linguistic concepts subtest of the celf-4uk assessment. * available to attend treatment for the whole week of 20th july 2009 * available to attend treatment for the whole week of 24th august 2009 exclusion criteria: * diagnosis of attention and/or hyperactivity disorders * diagnosis of moderate or severe general learning difficulties * diagnosis of moderate or severe receptive and/or pragmatic language difficulties * parent/carer for whom an interpreter would be required

Keywords: pilot stammer stutter children randomised controlled trial rct speech and language therapy stuttering
specific carbohydrate diet as maintenance therapy in crohn's disease

Conditions: Crohn's Disease

Summary: this study investigates whether the specific carbohydrate diet (scd) can maintain clinical remission in pediatric and adult patients with crohn's disease.

patients will be seen in clinic at new diagnosis of crohn's disease or a flare of existing disease. potential subjects will be screened with for eligibility, followed by a baseline assessment by the clinic provider. subjects who wish to participate will undergo further discussion with one of the study staff. at enrollment, a member of the study staff will explain the study to the prospective participant (for consent and/or assent, if applicable given patient's age). the scd will be started in addition to previous maintenance medication therapy or with short course of corticosteroids 1-2mg/kg/day (up to 60mg maximum). steroid induction based on clinical need. we anticipate improvement in clinical symptoms, laboratory values and/or a decline in pcdai of 12.5 points (pediatric patients) or decline in cdai of 70 points (adult patients) after 4 weeks. patients who do not reach remission by 4 weeks will be excluded from the study. patients who require additional medications for disease control will be excluded from the study. patients will be seen in clinic at diagnosis, 2 weeks (if required by clinical symptoms), 1 month, 3 months and 6 months. assessment at initial enrollment and at all follow-up visits includes: 1. history of symptoms 2. physical exam including height, weight, bmi, tanner staging 3. calculation of pediatric crohn's disease activity index (pcdai) for pediatric patients or the crohn's disease activity index (cdai) score for adult patients. 4. dietary assessment and nutritional counseling 5. completion of validated quality of life measurement (impact iii for pediatric patients and sibdq in adult patients) 6. adverse event monitoring (record of symptoms and review of laboratory surveillance) 7. laboratory assessment including: cbc with differential, basic metabolic panel, liver function tests, albumin, esr, crp, stool calprotectin and stool lactoferrin 8. serum sample for cytokine studies 9. stool studies for microbiota studies

Eligibility criteria:
inclusion criteria: * adult or pediatric patients presenting with a new diagnosis or flare of existing crohn's disease based on standard diagnostic criteria including: clinical symptoms, laboratory parameters, disease activity indices (pediatric crohn's disease activity index (pcdai) for patients \ 19years), pathology from upper endoscopy/colonoscopy and imaging studies. exclusion criteria:) * pregnancy * other autoimmune conditions including celiac disease, rheumatoid arthritis, multiple sclerosis * otherwise immunosuppressed patients including hiv and prior organ transplant * patients diagnosed with ulcerative colitis or indeterminate colitis * active tuberculosis

Keywords: carbohydrate specific diet crohn's disease immunomodulators
deferoxamine to prevent delayed cerebral ischemia after subarachnoid hemorrhage

Conditions: Subarachnoid Hemorrhage

Summary: the investigators will test the central hypothesis that dfo treatment after sah may improve cerebrovascular regulation, mitigate ischemic neural injury, and serve as an effective neuroprotectant against delayed ischemic injury after sah.


Eligibility criteria:
inclusion criteria: * diagnosis of spontaneous sah * impaired cerebral autoregulation on day 2-4 post sah exclusion criteria: * traumatic sah * other central neurological disorders such as tumors, known prior stroke, hemorrhage or vascular malformations * pregnancy * severe renal disease or anuria

Keywords: subarachnoid hemorrhage sah dfo cerebral autoregulation delayed cerebral ischemia
pulmonary blood flow measurements in chf patients

Conditions: Congestive Heart Failure (CHF)

Summary: historically, transthoracic doppler echocardiography has been unable to provide interpretable data of blood flow within the lung parenchyma because of air attenuation of doppler signals. recently, a transthoracic doppler system known as the sonara/tek transcranial doppler (tcd) system has been developed that can identify parenchymal pulmonary blood flow (ppbf) signals. the ability to non-invasively collect information regarding the pulmonary aspect of the cardio-pulmonary system may provide valuable information and new insights into the structural and functional characteristics of the lung parenchyma and vasculature in health and disease states.

this new system was previously studied among 31 healthy volunteers and one subject with atrial fibrillation.1 pulsed spectral doppler signals were obtained over the chest wall using a signal processing and algorithm package in conjunction with a non-imaging doppler device coupled with an electrocardiogram. clear reproducible lung doppler signals (lds) originating from different elements and phases of cardiac activity that generate mechanical waves which propagate throughout the lung were expressed in pulsatile changes in ultrasound reflections. after the completion of the first 25 patients in our pilot study, we have received some valuable information. after assessing patients with chf and pulmonary hypertension, we identified signals particular to the chf group. there were unique features that were never observed in the normal patients. on top of the regular lung doppler signals seen in normal patients, high velocity "disorganized" variable signals that were not synchronous with the heart beat, but rather sometimes with respiration were observed. we believe that the signals may represent popping open of small bronchi surrounded by "water filled" parenchyma. these events that generate very strong reflector like signals may represent the movement of fluid at the blood vessel-alveolar air junction.

Eligibility criteria:
inclusion criteria: * inclusion criteria 1. age over 50 years 2. belongs to one of the following categories: a. decompensated chf: patients with overt pulmonary congestion or pulmonary edema on admission, evident both clinically and by chest x-ray. patients may be with or without a swan-ganz catheter. b. compensated chf: patients with significant chf (nyha ii-iv) who are well controlled and without evidence of pulmonary congestion or pulmonary edema on admission. c. non-chf controls: patients without chf and without any of the following: pulmonary hypertension, any known pulmonary disease, uncontrolled hypertension. 3. signed informed consent exclusion criteria: * chronic obstructive pulmonary disease (copd) asthma interstitial lung disease any other obstructive or restrictive lung diseases pneumonia- currently or in the past 3 months prior to inclusion current or past pulmonary embolism non-cardiogenic pulmonary edema or lung injury (e.g. ards) right sided pleural effusion that is not mild severe kyphosis, scoliosis or chest wall deformity
breaking down care process and patient-level barriers to arteriovenous access creation prior to hemodialysis initiation

Conditions: Chronic Kidney Disease; Chronic Kidney Disease Requiring Chronic Dialysis

Summary: more than 80% of individuals in the u.s. start maintenance hemodialysis (hd) with a central venous catheter, despite substantial evidence that starting hd with an arteriovenous (av) access improves quality of life, lowers mortality, and decreases healthcare costs. health system- and patient-level barriers contribute to low rates of av access creation prior to hd initiation. evidence-based, pre-dialysis interventions to improve these low rates and associated clinical outcomes are lacking. a vascular access navigation and education quality improvement program will be implemented in the geisinger danville, pa chronic kidney disease clinic. individuals who choose to participate in a research sub-study of the program will complete questionnaires to assess their vascular access care knowledge and confidence before and after participation in the quality improvement program.


Eligibility criteria:
inclusion criteria patients: * receive care at the geisinger danville nephrology clinic * age ≥ 18 years * egfr ≤ 25 ml/min/1.73 m and 2-year kidney failure risk score \>10% based on kidney failure risk equation, or nephrologist recommendation for vascular access * participation in the vascular access navigation and education quality improvement program providers: professional involved in dialysis vascular access care (e.g., nephrologist, surgeon, kidney disease clinic nurse, etc.) at geisinger in danville, pa exclusion criteria patients: * too far into the vascular access creation process to benefit from the intervention (e.g. completed vascular access surgery appointment or has a surgery appointment scheduled within the next 4 weeks), * inability to consent, or * inability to complete interviews in english providers: none

Keywords: hemodialysis vascular access arteriovenous dialysis end stage renal disease patient-reported outcomes feasibility care process patient education health system navigation chronic kidney disease
sacrospinous ligament fixation vs ischial spine fascia fixation

Conditions: Urogenital Prolapse

Summary: a prospective, randomized comparison of efficacy and effect on quality of life between sacrospinous ligament fixation and ischial spine fascia fixation.

investigational intervention：sslf or isff operations study title：a prospective, randomized comparison of efficacy and effect on quality of life between sacrospinous ligament fixation and ischial spine fascia fixation. principal investigator：chang ren, m.d., department of obstetrics \& gynecology, peking union medical college hospital, chinese academy of medical sciences \& peking union medical college. study subjects：adult patients with symptomatic stage ii\~iv pelvic organ prolapse will be eligible if all the inclusion criteria are met and without any reason for exclusion. study objectives：the primary objective of this study is to assess the short and mid-term efficacy of sacrospinous ligament fixation and ischial spine fascia fixation in treating stage ii\~ iv pelvic organ prolapse and their recurrence rate as well as their impacts on quality of life. study design：prospective, single-blind, randomized, clinical trial intervention： * isff group：patients receive isff according to randomization. * sslf group：patients receive sslf according to randomization sample size：76 patients (38 in isff group, 38 in sslf group) primary endpoint: •objective success rates at 3 months after operations. secondary endpoints: * peri-operative parameters . * subjective satisfactory rates at 1 year after operations * quality of life questionnaires at 1 year after operations safety endpoints: complications

Eligibility criteria:
inclusion criteria: * age≤65 years, for those scheduled to receive hysterectomy age≥40 years * patients with symptomatic stage ii\~iv uterine or vaginal vault prolapse * receiving sslf or isff in the gynecological department at peking union medical college hospital exclusion criteria: * plans to live abroad within follow-up span * contradiction to these two operations: acute genital infection, narrow vagina (less than two finger-breadth), too-ill to receive operations * patients with hip joint problem who could not pose a lithotomy position

Keywords: pelvic organ prolapse sacrospinous ligament fixation ischial spine fascia fixation clinical outcome