Kornimate/medical-research-clean huggingface dataset:
safety and effectiveness of drug up titration by nurses specialized in heart failure (hf) patients

Conditions: Heart Failure

Summary: introduction: heart failure (hf) generates multiple hospital admissions and mortality, which are reduced with the administration of beta-blocker (bb), angiotensin converting enzyme inhibitor (acei), angiotensin ii receptor blocker (arb) and mineralocorticoid receptor antagonist (mra) drugs (level of evidence a). the effect is dose-dependent. nevertheless, dosages are suboptimal. european guidelines 2012 recommend close monitoring and up-titration of drugs by hf nurses. trials are needed to evaluate their effectiveness and safety. objective: to compare doses achieved by patients of bb, acei, arb ii and mra in 4 months ( % relative to target doses) in the intervention group (hf nurse) and in the control group ( cardiologist), adverse events, left ventricular ejection fraction (lvef), new york heart association (nyha), 6 min. walking test, quality of life, nt-probnp, readmissions and mortality. hypothesis: non-inferiority. design: multicenter randomized controlled trial. new ("de novo") hf patients with lvef ≤ 40%, nyha ii-iii, without contraindications to bb of 17 spanish hospitals will be included. intervention: the cardiologist prescribes drugs and, driven by protocol, the hf nurse implements the up-titration. in the control group doses are decided by the cardiologist clinical support and education being provided by nurses. variables: age, sex, education, psycho-social level, cardio vascular risk factors (cvrf), nyha, lvef, ischemic cardiopathy., n-terminal pro b-type natriuretic peptide (nt-probnp), 6min. walking test, creatinine/glomerular filtration rate (gfr), potassium (k), haemoglobin, blood pressure (bp), heart rate (hr), mg./drug, european heart failure self-care behaviour scale (ehfscbs), minnesota living with heart failure questionnaire (mlhfq), european quality of life scale (eq-5d). expected results: if our hypothesis were confirmed, evidence would be provided on the effectiveness of this healthcare management, that could be economically evaluated in future studies. a qualitative study also will be undertaken to explore barriers and facilitators to implementation

no apply

Eligibility criteria:
inclusion criteria: * patient with "de novo" heart failure and lvef \<= 40% admitted in hospital, without contraindications for bb prescription with cardiologist up-titration prescription and without having achieved bb target dose previous discharge and signing informed consent. exclusion criteria: * contraindications for bb. * living in a nursing home. * life expectancy \< 6 months. * unable to self-care or mental disease without caregiver. * unable to weight * without phone * unable to go to clinic visit.

Keywords: up-titration nursing or nurse heart failure
reflexology for chronic constipation

Conditions: Chronic Constipation

Summary: the purpose of this study is to examine if the use of reflexology can alleviate chronic constipation. the trial will last 26 week per patient, 2 week of screening period, 12 weeks of treatment and 12 weeks of follow up. included in the study will be 40 men and women, 18 years of age or older, which are able to comply with the study guidelines; fewer than three spontaneous bowel movement per week; and one or more of the following symptoms/signs during more than 25% of bowel movements for at least 12 weeks within the preceding 12 months: (1) straining, lumpy or (2) hard stools, and (3) a sensation of incomplete evacuation. exclusion criteria are: loose or watery stool in the absence of laxative use for more than 25% of bowel movements during the 12 weeks preceding the trials; mushy stool defined as a score of 6 on the bristol stool form scale for any sbm during the baseline period; rome iii criteria for the irritable bowel syndrome; history of pelvic-floor dysfunction; neurological pathologies; psychiatric conditions; chronic use of medication with a gastro intestinal-activity.


Eligibility criteria:
inclusion criteria: * age of 18-55 years * fewer than three sbms per week (occurring without the use of a laxative, enema, or suppository within the preceding 24 hours) * one or more of the following symptoms/signs during more than 25% of bowel movements for at least 12 weeks within the preceding 12 months:(1)straining, lumpy or (2) hard stools, and (3)a sensation of incomplete evacuation six or fewer sbms/week and fewer than three complete csbms/week during the 14-day baseline period. * ability to comply with the study guidelines exclusion criteria: * loose or watery stool in the absence of laxative use for more than 25% of bowel movements during the 12 weeks preceding the trials. * mushy stool defined as a score of 6 on the bristol stool form scale for any sbm during the baseline period. * rome iii criteria for the irritable bowel syndrome. * history of pelvic-floor dysfunction. * neurological pathologies * psychiatric conditions * chronic use of medication with a gi-activity.

Keywords: chronic constipation reflexology complementary medicine
influence of food preferences on the occurrence of undernutrition in treated patients for bronchopulmonary carcinoma non-small cell stage iv

Conditions: Non-small Cell Bronchopulmonary Carcinoma at Stage IV and Benefiting From First-line Treatment According to Current French Recommendations

Summary: the study will be offered to patients with non-small cell lung carcinoma diagnosed at stage iv and receiving first-line treatment. the patient will benefit from a complete assessment at inclusion (clinical exam, imagery, biological exam, dietary consultation, test lfqp. at the end of this 1st evaluation, patients in whom the diagnosis of undernutrition is made will benefit from dietary management with personalized advice that will take into account the symptoms of cancer, the possible side effects of treatments as well as the social environment. every two cures, i.e. every 4 to 6 weeks, these examens will be performed until the occurrence of an event (progression of the disease according to the recist criteria, death or change of therapeutic line). at the end of these assessments, patients will benefit from dietary management with a readjustment of personalized advice that will take into account the difficulties highlighted during the assessment.


Eligibility criteria:
inclusion criteria: * diagnosis of stage iv non-small cell lung carcinoma with indication for first-line systemic treatment (chemotherapy, immunotherapy or specific treatment, in particular tyrosine kinase inhibitors) according to current french recommendations. * age over 18 and under 70 * patient speaking and reading french fluently * affiliation to a social security scheme * patient able and willing to follow all study procedures in accordance with the protocol * patient having understood, signed and dated the consent form exclusion criteria: * patient requiring hospitalization for more than 48 hours for the administration of the first course of treatment * patient benefiting from antibiotic therapy for the treatment of an acute infection * psychiatric, cognitive or neurological disorders making it impossible to assess food preferences and/or any impossibility to undergo medical monitoring for the trial for geographical, social or psychological reasons. * daily alcohol consumption * chest radiotherapy treatment * pregnant woman, likely to be, or breastfeeding * persons deprived of liberty or under guardianship
outcome of proximal humerus fractures :anatomic neck fractures vs surgical neck fractures

Conditions: Humeral Fracture, Proximal; Internal Fixation; Complications, Mechanical, Bones of Limb

Summary: from april ,2014 to april 2015,31 patients with fractures of the proximal humerus were treated in our hospital. according to anatomic neck fractures (anf) and surgical neck fractures (snf), we divided the patients into two groups. all the patients were followed at least 1 year.


Eligibility criteria:
inclusion criteria: -from may ,2013 to april 2015, patients with fractures of the proximal humerus who were treated with locking plate. exclusion criteria: * patients had pathologic fractures, * patients had previous surgery on the affected shoulder, * patients were treated with shoulder arthroplasty. * patients were treated with intramedullary nail.
belimumab treatment holiday and treatment re-start study in lupus patients

Conditions: Systemic Lupus Erythematosus

Summary: this study will assess the effect of a 24-week withdrawal followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications in subjects with stable low systemic lupus erythematosus (sle) disease activity. rebound phenomenon will be assessed for subjects who have permanently withdrawn from further belimumab treatment.

this study will assess the effect of a 24-week withdrawal of belimumab followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications on immunogenicity, markers of biological activity, efficacy, and safety in subjects with stable low systemic lupus erythematosus (sle) disease activity. additionally, this study will assess rebound phenomenon in subjects with any disease level of sle who have permanently withdrawn from further belimumab treatment

Eligibility criteria:
inclusion criteria: * received a minimun of 6 months therapy with with belimumab 10 mg/kg in their current sle belimumab continuation study. * be 18 years of age at the day 0 visit. * non-prenant, non-lactating females willing to comply with specific birth control requirements as set forth in the protocol. * able to provide written informed consent to participate. * subjects who wish to enroll in the control group and the group taking a 6 month belimumab treatment holiday will need a selena sledai score of 3 or less after the minimum of 6 months belimumab therapy, as well as having c3 and c4 complement levels at or above the lower limit of the central laboratory reference range, and are on a stable sle treatment regimen during the 30 day screening period prior to day 0. * subjects who wish to enroll in the long-term discontinuation group have voluntarily withdrawn from their continuation studies. exclusion criteria: * subjects who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to sle, or experienced an adverse event (ae) in their belimumab continuation study that could, in the opinion of the principle investigator, put the subject at undue risk. * subjects who have developed any other medical diseases, laboratory abnormalities, or conditions that, in the opinion of the principle investigator, makes the subject unsuitable for the study.

Keywords: treatment holiday pga belimumab lymphostat-b rebound selena sledai systemic lupus erythematosus immunogenicity
web-based addiction treatment: cultural adaptation with american indians

Conditions: Substance Use Disorders

Summary: the purpose of the current study is to evaluate the preliminary efficacy of the therapeutic education system-native version (tes-nav) (an efficacious web-delivered psychosocial intervention for substance use disorders adapted with american indians/alaska natives \[ai/an\]) to determine whether a future large-scale effectiveness trial is warranted. specifically, a randomized controlled trial among urban ai/an (n=80) attending outpatient addiction treatment services will be conducted to (1) estimate preliminary effect size of 12 weeks of tes-nav on substance use disorder outcomes; (2) explore relevant moderators of tes-nav outcomes; and (3) assess cultural factors that may correspond to variation in outcome.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * identify as american indian or alaska native * recent alcohol or drug use * within first 30 days of current outpatient treatment episode exclusion criteria: * planned treatment episode of less than 3 months * insufficient ability to provide informed consent

Keywords: digital therapeutics adaptation
considering peripheral nerve injury, is it safe to perform transradial angiography?

Conditions: Neuropathic Peripheral Pain

Summary: so far, apart from a limited number of case reports and small-scale studies, the frequency and severity of this complication have not been objectively evaluated using electromyography (emg). in this study, presence, severity, and extent of nerve injury (one of the potential complications following the transradial approach (tra)) were evaluated by emg studies in patients managed at bursa city hospital.

evaluation of peripheral nerve injury after transradial angiography with nerve conduction studies.

Eligibility criteria:
inclusion criteria: 20-60 years old patiens who applied trans angiograhy were included to study exclusion criteria: * having cognitive disorders * patients who have story of cardiac pace / icd, * history of polyneuropathy, * previous nerve damages, * deformities on arm, * plexopathy, * radiculopathy, * spinal surgery. * having medical treatment for any kind of neuropathy * having cognitive disorders

Keywords: nerve conduction studies nerve damage transradial angiography
internet-based programmes for the prevention of suicidal ideation in medical students

Conditions: Suicidal Ideation

Summary: two programmes have been built to prevent suicidal ideation; one focuses on stress management based on cognitive and behavioural principles and the other on health promotion.

the main objective will be assessing their respective effectiveness on suicidal ideation (at least one occurrence over a 12-month period after the end of the intervention), through a randomized controlled trial, in medical students and interns.

Eligibility criteria:
inclusion criteria: * being registered in the fourth year of medical studies or in the first year of residency (internship), as they appear as two critical periods over medical studies * being registered in the i-share cohort * 18 year-old and over * speaking and reading french * having given an informed consent * ability to understand the type, the aims and the methodology of the study * agreement for online clinical assessment * having a mobile phone number and an e-mail address * to be beneficiary of a health insurance programme exclusion criteria: * refusing to participate * protective supervision: curatorship, guardianship
wound closure (allgower) versus secondary open wound healing after removal of the external fixator

Conditions: Infection Rates Between Primary Wound-closure (Allgower) and Secondary Wound Healing After Removal of an External Fixator

Summary: in this prospective randomized controlled single-center trial, based on a non-inferiority design, the outcome of the treatment of patients are analyzed, whereas in half of the cases the wounds are left open and the other ones are primary wound closed after local debridement after fixator-extern is removed. although this topic embodies a daily business, there is no standard to be found in literature regarding the treatment of pin sites with closure by either primary or secondary intent.

in the orthopedic department of the kantonsspital lucerne (luks) after removal of the external fixator, the pin sites at the tibia and the back of the foot are routinely treated with primary wound closure. an international survey carried out by the luks shows that in comparison to our standard treatment the majority of surgeons left the pin sites open during the healing process. in order to find a standardized method to treat pin sites we conduct a randomized controlled trial, in which half of the pin site wounds are left open and the other half are treated by primary wound closure after local debridement (treatment of the first pin-side will be randomized, then alternated treatment of the consecutive pin-sides). all patients of the study participants are treated within a fixed pre- and postoperative protocol, which includes antibiotic prophylaxis with a single shot of cefazolin 2g intravenously 30 minutes prior to surgery. the postoperative pin care includes daily inspection of the pin sites, cleaning the secondary healing wound with ringerfundin © and disinfection with betadine ©. primary wound closures are dressed with dry gaze bandage. the following out-patient treatment is provided either by a spitex support, the family doctor or by the patient himself, depending on the patients compliance. regular follow-up consultations at 2, 6, 12, 24 and 52 weeks after surgery ensure an adequate surveillance of the healing process, whereas the examining doctor at the second and last consultation was kept in dark what therapy was chosen for pin sites of the patient. to objectify the clinical progress the pin sites are photo documented at the consultations at week 2 and 52.

Eligibility criteria:
inclusion criteria: * completed 18th year of age * supply by external fixator * signed informed consent for study participation exclusion criteria: * patients with immunodeficiency (hiv / hepatitis infection, leukemia, steroid therapy, autoimmune therapy) * patients who can not perform a follow-up treatment for structural reasons (tourists, not home canton) or other reasons * lack of knowledge of german * lack of consent to study participation * invalid patients

Keywords: fixator extern fixateur externe external fixator wound healing fix-ex pin side trauma infection
effectiveness of the adsorbed vaccine covid-19 (coronavac) among education and public safety workers with risk factors for severity

Conditions: Covid19

Summary: this is a quasi-experimental study with risk-based allocation. public security and education professionals from the state government will be included. in the initial evaluation, the presence of comorbidities associated with an increased risk of serious disease due to covid-19 will be evaluated, according to the national plan for the implementation of vaccination against covid-19. those with at least one of these comorbidities will be invited to receive the study vaccine in two doses, with an interval of 28 days (±7 days). participants with low risk (without comorbidities as a risk factor for severe covid-19 according to the national plan for the implementation of vaccination against covid-19) will not receive the vaccine within the scope of the research project. if, after 12 months, the participant in the low-risk group (no vaccine) has not received coronavac, or any other vaccine available, he/she will receive the vaccine, exactly as offered in the other group (two doses of coronavac with an interval of 28 days - with a tolerance of 7 days before or after). all participants will be followed up for 12 months from inclusion in the study. immunization is expected to reduce the risk of moderate to severe disease of those with comorbidities to the level of those of the same age group who do not have these comorbidities but face similar occupational risks.


Eligibility criteria:
inclusion criteria: * age between 18 and 49 years * demonstrate availability to be accompanied during the follow-up time defined in the study, through visits, telephone contacts, or other means of digital communication. exclusion criteria: * prior vaccination for covid-19; * diagnosis of covid-19 in the last 28 days (nasal and oropharyngeal swab); * history of severe allergic reaction or anaphylaxis to study vaccine components; * report of fever in the 72 hours prior to vaccination (the inclusion may be postponed until the participant completes 72 hours without fever); * possible or confirmed of covid-19 on the day of vaccination (in this situation, vaccination can be postponed until the participant completes 72 hours without symptoms or the diagnosis is ruled out); * have received live attenuated virus vaccine in the last 28 days or inactivated vaccine in the last 14 days prior to inclusion in the study, or have immunization scheduled for the first 28 days after their inclusion in the study; * any other condition that, in the opinion of the principal investigator or his medical representative, could endanger the safety or rights of a potential participant or that would prevent him or her from complying with this protocol; * pregnancy or breastfeeding.

Keywords: sars-cov-2 brazil covid-19 vaccine sinovac coronavac vaccine efficacy
reduce lap-hf iii corvia protocol 1701

Conditions: Heart Failure

Summary: this is a post market trial to be conducted at sites in germany. the device has ce approval in the eu. the purpose of this observational registry is to collect post market data in consecutive patients treated with the iasd system ii, to further evaluate efficacy, safety and quality of life outcomes as a new treatment for patients with heart failure in a "real world" practice setting.


Eligibility criteria:
this is a post market registry so no criteria requirements (only recommendations).
mesenchymal stem cell transplantation in osteoarthritis of hip joint

Conditions: Hip Osteoarthritis

Summary: osteoarthritis of the hip is a common type of osteoarthritis which can cause significant problems. first-line of management for patient with osteoarthritis consists of weight reduction, education, and analgesic medication. if necessary, invasive treatment like total hip replacement are performed for the patient. the objective of this study was to assess the safety of bone marrow mesenchymal stem cells (bm-mscs) implantation in patients with hip osteoarthritis

this is a phase one clinical study designed to investigate the safety of intra-articular injection of cultured autologous bm-mscs in patients with severe hip osteoarthritis candidate for total hip replacement. all subjects will undergo bone marrow aspiration. autologous mscs will be extracted and cultured for 4 weeks. patients will receive intra-articular injection of cultured mscs under the guide of fluoroscopy. paraclinical studies (x-ray and mri) will be done before and 6 months after treatment. pain relief and functional improvement of the joint will be assessed by vas, womac, and harris hip score questionnaire before treatment, and 2 and 6 months after treatment.

Eligibility criteria:
inclusion criteria: * osteoarthritis diagnosed by mri * end stage osteoarthritis candidate for total hip replacement exclusion criteria: * pregnancy or lactating * positive tests for hiv, hcv, hbv * active neurologic disorder * end organ damage * uncontrolled endocrine disorder

Keywords: osteoarthritis hip joint mesenchymal stem cell