Kornimate/medical-research-clean huggingface dataset:
apatinib with cdk4/6 inhibitor and endocrine therapy in hr+/ her2- advanced breast cancer

Conditions: Breast Cancer Metastatic

Summary: this study is a prospective, open-label, phase ii clinical study for patients with hr+/her2- advanced breast cancer.

patients with snf34subtype of hr+/her2- advanced breast cancer confirmed by the department of pathology and key laboratory of breast cancer of fudan university affiliated cancer hospital are planned to be enrolled. the main purpose is to evaluate efficacy of apatinib in snf4 subtype of hr +/her2- advanced breast cancer and prepare for subsequent randomized controlled phase iii clinical studies with larger sample size.

Eligibility criteria:
inclusion criteria: * females ≥18 years and ≤ 75 years old; * histologically confirmed hr + / her2- invasive breast cancer (specific definition: immunohistochemical detection of er\> 10% tumor cell positive is defined as er positive, pr\> 10% tumor cell positive is defined as pr positive, er and / or pr positive is defined as hr positive; her2 0-1 + or her2 is ++ but negative followed by fish detection, no amplification, defined as her2 negative); * subtype of similarity network fusion-4 (snf-4) confirmed by the department of pathology and key laboratory of breast cancer of fudan university affiliated cancer hospital • locally advanced breast cancer (incapable of radical local treatment) or recurrent metastatic breast cancer; * measurable disease according to response evaluation criteria in solid tumors v1.1 (recist v1.1); or unmeasurable lytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions; * has adequate bone marrow function: absolute neutrophil count \> 1.5x10ˆ9 /l; platelet count \> 75x10ˆ9 /l, hemoglobin \> 9g/dl; * patients had received no previous chemotherapy or targeted therapy for metastatic disease - page 3 of 4 \[draft\] - * has adequate liver function and kidney function: serum creatinine * ecog score ≤ 2 and life expectancy ≥ 3 months; * participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up exclusion criteria: * treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) for metastatic disease * symptomatic, untreated, or actively progressing cns metastases(glucocorticoids or mannitol needed to control symptoms); * significant cardiovascular disease(including congestive heart failure, angina pectoris, myocardial infarction or ventricular arrhythmia in the last 6 months); * is pregnant or breast feeding; * malignant tumors in the past five years (except cured skin basal cell carcinoma and cervical carcinoma in situ).

Keywords: first-line therapy
a study of cardiovascular disease awareness and cardiovascular health

Conditions: Cardiovascular Diseases; Cardiovascular Health

Summary: the objective is to increase awareness of various cardiovascular diseases (cvds) through an interactive, educational experience to promote cardiovascular health (cvh) via an inflatable heart model exhibit and assess community cvd knowledge and whether this experience is an acceptable tool to promote and provide education on cvh.


Eligibility criteria:
inclusion criteria: * mn resident * active email address * ≥18 years of age exclusion criteria: - inability to speak, read or understand english
effects of supervision during a community-based exercise intervention (urban training) in patients with copd

Conditions: Chronic Obstructive Pulmonary Disease; Lung Diseases, Obstructive; Respiratory Tract Diseases

Summary: this project plans on a community-based exercise intervention (urban training) combined with therapeutic education program, by using public spaces and urban walkable trails, adapted to each patient needs and capabilities in patients with chronic obstructive pulmonary disease (copd). the main objective of the present study is to evaluate the effects comparing different levels of supervision (face-to-face vs telematic) in the short-, medium- and long-term with respect to: (primary outcome): exercise capacity, and (secondary outcomes): physical activity, quality of life, mental health and copd exacerbations.

it is a single-blind randomized clinical trial study. each participant will be randomly assigned to one of the following groups: (1) urban training intervention + therapeutic education program with face-to-face supervision, (2) urban training intervention + therapeutic education program with telematic supervision each exercise training program will be applied once per day, 3 sessions per week during 12 weeks. the group with urban training intervention with face-to-face supervision will be supervised by a physiotherapist once a week. the group with urban training intervention with telematic supervision will be supervised by a phone call once a week. to record compliance, participants from all groups were asked to complete a diary at the end of every training session. the therapeutic education program will consisted of 1 session/week during 4 weeks. participants received baseline assessments at the beginning of the intervention, post-intervention assessments at the end of the 13th week, 6 months of follow-up and 12 months of follow-up.

Eligibility criteria:
inclusion criteria: * age \> 18 years * copd diagnosed by pulmonary function tests during clinical stability, with a ratio of forced expiratory volume in one second (fev1) to forced vital capacity (fvc) ≤ 0.70 * clinical stability, defined as at least 6 weeks without copd exacerbation exclusion criteria: * neuromuscular or neurological disorders and/or psychiatric or cognitive conditions that hindered they ability to cooperate * comorbidity that could interfere with study intervention (e.g., severe orthopaedic problems) * previous inclusion in a rehabilitation programme (previous 6 months)

Keywords: exercise therapy telerehabilitation exercise tolerance physical activity
efficacy of combined ibuprofen and acetaminophen therapy versus ibuprofen alone versus placebo alone for pain management

Conditions: Pain, Orofacial

Summary: the purpose of this study is to compare the effectiveness of a combined ibuprofen and acetaminophen regimen in controlling discomfort for 4 days after initial orthodontic appliance placement as compared to ibuprofen alone or a placebo. the hypothesis is that combined ibuprofen and acetaminophen therapy will effectively provide better pain control than ibuprofen alone or a placebo after orthodontic appliance placement.

orthodontic pain is often reported for the first 4 days after the appliances are attached. this study will investigate two modes of pain management versus a placebo. consented subjects will be randomly assigned to one of 3 groups: group a, a combined and simultaneous therapy of 200 mg ibuprofen and 650 mg acetaminophen (3 pills total) taken orally at set time intervals (0 h, 6 h, 12 h, and 24h, 48h, 72h, and 96h); group b, ibuprofen alone (200 mg) taken orally at same time intervals (1 ibuprofen and 2 placebo pills); group c, placebo taken orally at the same time intervals (3 placebo pills). the study will be blinded for the investigators, patients, and statisticians.

Eligibility criteria:
inclusion criteria: * scheduled to begin comprehensive orthodontic treatment (banding/bonding of at least 10 teeth in 1 arch and archwire placement in at least 1 arch); * extractions, if required, performed at least 2 weeks before appliance and archwire placement; * healthy with no significant medical findings; * no prophylactic antibiotic coverage required; * currently not taking antibiotics or analgesics; * no contraindications to the use of acetaminophen or ibuprofen; and * minimum age of 12 years exclusion criteria: * under the age of 12 or over the age of 80, * prisoners, * pregnant women, * decisionally challenged individuals, * allergy to either medication, * history of kidney disease, * liver damage or disease, * alcoholism/use of 3 or more alcoholic drinks during study period, * use of blood thinners, * stomach ulcers or * stomach bleeding.
palbociclib induced neutropenia; risk factors and treatment outcome in metastatic breast cancer patients

Conditions: Metastatic Breast Cancer

Summary: aim of the study to assess the neutropenia induced by palbociclib in patient receiving palbociclib in combination with hormonal treatment as first-line therapy in metastatic hormone receptor- positive her2 negative breast cancer. to evaluate the risk factors for occurrence of neutropenia and treatment outcome as 2 years pfs and os.

palbociclib is an orally active cyclin-dependent kinase (cdk) and is considered the standard treatment for hormone receptor (hr)-positive, (her) negative metastatic breast cancer. the paloma studies' showed improvement in progression-free survival (pfs) compared to endocrine therapy alone but a non-significant trend towards improved overall survival (os). monaleesa and monarch suggest significantly improved os with the addition of cdk inhibition. neutropenia is considered the dose-limiting and most frequent adverse effect of cdk inhibitors resulting in frequent dose reductions and treatment interruptions that are potentially associated with a lack of efficiency. grade iii/iv neutropenia rates were 62-66% in the paloma studies. some studies investigated the risk factors for the development of palbociclib-induced neutropenia. one concluded that no concomitant use of statins and high bmi were identified as significant predictors for the development of palbociclib-induced neutropenia. and another study also concluded that low baseline anc, wbc, plt, and bsa were associated with early grade iii/iv neutropenia. regarding treatment outcome, two phase two clinical trials concluded that the treatment-related neutropenia in the first two cycles was significantly and independently associated with prolonged pfs, suggesting that neutropenia may be a useful pharmacodynamic marker to guide individualised palbociclib dosing. however, another study concluded that limited dose modification may lead to longer pfs, without increasing toxicity, than the conventional dose scheme. a study of variable risk factors and treatment outcomes for palbociclib-induced neutropenia will be useful for careful monitoring leading to adapted therapy.

Eligibility criteria:
inclusion criteria: * histological pathological confirmation of primary breast cancer or metastatic disease. * hormonal receptor-positive, her2 negative. * metastatic breast cancer at presentation (den novo) or recurrent. * patients did not receive any previous systemic therapy for metastatic disease. * performance status (ecog) 0-2. exclusion criteria: * patient with co-morbidity * pregnant and breast lactating women
comparison of two chest radiograph prescription strategies in intensive care unit

Conditions: Patient Care; Quality of Health Care; Intensive Care Units; Ventilation, Mechanical

Summary: current guidelines recommend routine daily chest radiographs (cxrs) for mechanically ventilated patients in intensive care units (icus). however, some icus have shifted to an on-demand strategy, in which this cxr is only prescribed if warranted by the patient's status at the morning physical examination. here the investigators compared routine and on-demand strategies in 21 french icus. the working hypothesis was that cxr prescriptions would fall by at least 20% with the on-demand strategy, with no reduction in quality of care.

based on a cluster-randomized two-period two-strategies cross-over design, respectively 11 and 10 participating icus applied the routine and on-demand strategies during the first period, each enrolling 20 consecutive patients requiring mechanical ventilation for at least two days. each icus applied then applied the alternative strategy during the second period, again enrolling 20 consecutive patients.

Eligibility criteria:
inclusion criteria: * all newly admitted adult patients receiving mechanical ventilation at the time of the morning visit-any day during their icu stay exclusion criteria: * patients with mechanical ventilation lasting less than 2 days

Keywords: radiography, thoracic intensive care units ventilation, mechanical matched-pair analysis
impact of alternative treatment strategies and delivery systems for soil-transmitted helminths in kenya

Conditions: Helminthiasis; Nematode Infection; Disease Transmission, Infectious

Summary: the mainstay of control of soil-transmitted helminths (sth) is school-based deworming but recent modelling has highlights that in all but low very transmission settings, the treatment of school-aged children is unlikely to interrupt transmission, and that new treatment strategies are required. this study seeks to answer the question: is it possible to interrupt the transmission of sth and if so, what is the most cost-effective treatment strategy and delivery system to achieve this goal? in this study, two paired community cluster randomised trials in different settings in kenya will evaluate the impact and cost-effectiveness of annual school-based deworming, annual community-based deworming, and biannual community-based deworming. the interventions are (i) annual mass anthelmintic treatment delivered either to pre-school and school-aged children, as part of a national school-based deworming programme, or to the entire community delivered by community health workers. the primary outcome measure is the prevalence of hookworm infection (the most common sth species), assessed by periodic cross-sectional, age-stratified parasitological surveys. secondary outcomes include intensity of hookworm, prevalence and intensity of ascaris lumbricoides, treatment coverage, and among a randomly selected sub-sample of participants who will be followed longitudinally, worm burden and proportion of eggs unfertilised. a nested process evaluation, using semi-structured interviews, focus group discussions and a stakeholder analysis will investigate the community acceptability, feasibility given the local and regional health system structures and processes, and scale-up of the interventions.

the study will be conducted in two settings of kenya that have contrasting epidemiological and programmatic characteristics, kwale county on the south kenyan coast and bungoma county in western kenya. allocation to study group will be by cluster, using predefined units used in public health provision - termed community units (cus), which comprise approximately 1,000 households or 5,000 people. cus will be randomized to one of three groups, receiving either (i) annual school-based deworming; (ii) annual community-based deworming; (iii) biannual community-based deworming. in nine cus, a longitudinal study will be conducted in order to better understand the transmission dynamics of sth.

Eligibility criteria:
inclusion criteria: * usual resident of study community or student enrolled in study school; * willingness of adult aged 18 years and above or parent/guardian to provide written informed consent; * provision of written assent to participate from children aged 8 years and above. exclusion criteria: * visitor to household at time of household visits; * refusal of informed consent; * refusal to assent by children aged 8 years and above.

Keywords: soil-transmitted helminths intestinal nematodes hookworm ascaris mass treatment kenya
a study to verify the efficacy of ym177 (celecoxib) in postoperative pain patients

Conditions: Post Operative Pain

Summary: aim of the study is to compare efficacy and safety of ym177 with placebo and etodolac in patients with postoperative pain.

to verify the superiority to placebo and the noninferiority to etodolac of ym177 in terms of efficacy assessment in patients with postoperative pain. also, to compare them in terms of safety assessment.

Eligibility criteria:
inclusion criteria: * patients with spontaneous pain within 24 hours postoperatively * the intensity of the pain: * 4-categorical assessment: "moderate pain" or "severe pain" * vas assessment: 45.0 mm or higher * patients whose postoperative pain can be managed using an oral nsaid exclusion criteria: * a past history of aspirin-induced asthma * a past of ischemic heart disease, serious arrhythmia, congestive heart failure or cerebrovascular disease * patients who undergoes the surgical procedure under general anesthesia * patients taking excluded medications

Keywords: celecoxib celecox pain surgery nsaids
alisporivir with peg and rbv in protease inhibitor (pi) treatment failure patients with chronic hepatitis c

Conditions: Hepatitis C

Summary: this study is to evaluate the overall efficacy, and safety profile of the triple combination therapy of alisporivir (alv; deb025) plus peginterferon alfa-2a (peg) and ribavirin (rbv) patients with chronic hepatitis c (hcv) genotype 1 who failed prior treatment with a protease inhibitor (pi).


Eligibility criteria:
inclusion criteria: 1. patients with chronic hcv genotype 1 infection with previous pi treatment failure 2. three months minimum time from the last dose of previous pi treatment to the first dose of study medication exclusion criteria: 1. use of other investigational drugs at the time of enrollment 2. history of hypersensitivity to peg or rbv 3. any null non-responders to prior peg/rbv treatment other protocol-defined inclusion/exclusion criteria may apply.

Keywords: hepatitis c pi treatment failure
a study of hrs-7535 compared with placebo in adult participants with type 2 diabetes and inadequately controlled with diet and exercise

Conditions: Type 2 Diabetes

Summary: the aim of this trial is to evaluate the efficacy and safety of hrs-7535 compared with placebo in subjects with type 2 diabetes mellitus with inadequate glycemic control with diet and exercise


Eligibility criteria:
inclusion criteria: 1. male or female, 18-75 age years, both inclusive; 2. type 2 diabetes mellitus diagnosed for at least 2 months before the screening visit; 3. hba1c 7.0-10.0% (both inclusive) at screening; 4. treated with diet and exercise, and without any antidiabetic drugs at least 8 weeks prior to screening. exclusion criteria: 1. known or suspected allergy to the investigational drug or its components or excipients. 2. diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes. 3. have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening. 4. proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment; 5. pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (wocbp) or male subject not using adequate contraceptive measures.
evaluating the impact of covid-19 (coronavirus) on research in care homes

Conditions: Covid19

Summary: during the covid-19 (corona virus) pandemic the research arena has had to rapidly adapt and change in order to facilitate and deliver research. the uk (united kingdom) government and public health england have stressed the importance of such research to find solutions to treating, preventing and stopping the spread of covid-19. due to national and international 'lock down restrictions' delivering research in care home settings has become even more challenging. the adaptations to conducting consultations have relied heavily on the use of technology, for example video calling, telephone, email, and teleconferencing. it is suggested that the use of technology in care home settings is already a barrier to effective research delivery. nevertheless, as care home residents are a vulnerable group, it is critical to include these groups in research in order to enable improved and evidence-based care and their access to new and emerging treatments. this study aims to assess the opinions and experiences of key stakeholders to identify barriers, and enable better facilitation of research in these settings during and post pandemic.

this two phase project will use a mixed methodology. phase one will involve mixed methods surveys. one will be completed by care home residents and the other will be completed by research delivery staff and care home staff. phase two will involve qualitative interviews with each of these groups to enable better insight into their views and opinions on research in this area.

Eligibility criteria:
inclusion criteria: * any resident of a care home in the west midlands * any relative/friend of a care home resident in the west midlands * any staff member or volunteer working in care home in the west midlands * any researcher undertaking research in a care home in the west midlands (during the pandemic or proposed during the pandemic period) exclusion criteria: * individuals who are unable to give informed consent * individuals who lack capacity
a comparative study using two 3d printed occlusal splints for patients with tempromandibular disorder

Conditions: Temporomandibular Disorder

Summary: • to compare the relief of pain for patients with anterior disc displacement with reduction between two groups; in the first group a digitally formed stabilizing splint followed by an anterior repositioning splint (ars) and the second group a digitally fabricated (ars) splints followed by a stabilizing splints


Eligibility criteria:
inclusion criteria: * • tmds according to the research diagnostic criteria (rdc)8 which include: i. painful tmj audible and palpable click unilateral or bilateral ii. presence of clicking during opening. iii. tmj tenderness. * fully dentate patients without any malocclusion (natural or restored by fixed prothesis) and good oral hygiene. * co-operative patient that should show motivation to follow up. exclusion criteria: * • patients with systemic diseases which could affect tmj, e.g., rheumatoid arthritis, osteoarthrosis, myasthenia gravis and fibromyalgia. * patients taking analgesic, muscle relaxant, or anti-inflammatory drugs were excluded because such drugs could influence the results. * patients with removable dental prosthesis
molecular characterization of spinal tissue

Conditions: Spinal Diseases

Summary: the researchers are trying to identify molecular mechanisms that control spine deformity and degenerative changes that can be used for therapeutic strategies.

discarded surgical material from spinal procedures is collected. rna analysis and other tests on the tissue is performed to determine markers of pathologic disease and to develop pharmacologic treatment strategies for pediatric spinal disorders.

Eligibility criteria:
inclusion criteria: * children and adults undergoing surgical procedures where spinal tissues are removed as a normal part of their procedure. material from adults may be collected as a control group. exclusion criteria: * surgeries where spinal tissues are not being removed.