Kornimate/medical-research-clean huggingface dataset:
a randomised open-label phase iii trial of reduced frequency pembrolizumab immunotherapy for first-line treatment of patients with advanced non-small cell lung cancer (nsclc)

Conditions: Lung Cancer, Nonsmall Cell

Summary: refine-lung will test whether reduced pembrolizumab dose frequency after 6 months of standard treatment is safe and effective. patients treated with 1st line pembrolizumab who are progression free and otherwise planning to continue therapy at 6 months will be initially randomised to control 6 weekly versus interventional 12 weekly therapy. if an interim analysis shows that the 12 weekly treatment is no less effective, subsequent patients will also be randomised to 9, 15 and 18 weekly treatment frequency arms. patients who progress on a reduced frequency arm will be offered re-escalation to standard 6 weekly therapy.

immunotherapy with pembrolizumab targeting the t cell inhibitory pd-1 receptor has significantly improved outcomes in advanced non-small cell lung cancer (nsclc). approximately 3600 new patients are treated in the 1st line setting per year in england alone and up to 25% remain on 6 weekly pembrolizumab for 2 years. however, pharmacological and clinical trial data suggest current frequent dosing for 2 years result in overtreatment. indeed, pembrolizumab remains bound to its target receptor for up to 100 days following a single dose and studies in multiple tumour types have found no relationship between dose and patient outcome. moreover, anti-pd1 treated patients who respond but discontinue therapy either as planned after 2 years, or earlier because of toxicity, can either remain in remission and/or be sensitive to re-challenge with pembrolizumab. refine-lung will test whether reduced pembrolizumab dose frequency (9, 12, 15, 18 weeks) after 6 months of standard treatment is safe and effective. this uk study represents a unique opportunity to determine whether pembrolizumab dose frequency can be safely reduced in nsclc, resulting in significant cost benefits to the nhs and globally, in addition to enhanced patient qol associated with fewer hospital attendances and reduced toxicity.

Eligibility criteria:
inclusion criteria: * written informed consent prior to initiation of any study procedures and willingness and ability to comply with the study schedule * any patient ≥18yrs who has received 6 months of pembrolizumab treatment with or without chemotherapy for advanced non small cell lung cancer who is planned to continue immunotherapy treatment because of continued benefit. exclusion criteria: * disease progression or not tolerating treatment at 6 months into therapy * clinician does not intend to continue immunotherapy * any patient with a synchronous primary cancer. this includes any new cancer diagnoses or relapse of previously treated cancer since starting pembrolizumab treatment. * any patient currently receiving an investigational agent and/or using an investigational device or has participated in a study of an investigational agent and/or used an investigational device within 28 days of randomisation.
chinese cohort study of coronary heart disease

Conditions: Coronary Heart Diseases

Summary: construction of coronary heart disease cohort of more than 10000 patients in china. investigation on current situation of secondary prevention of chd will be carried out and the effect of physician training and patient education will be evaluated.

more than 40 hospitals of 16 provinces will enroll patients for this study. the study will include patients with diagnosed coronary heart disease. investigators and all the physicians who will involve in daily care of chd patients will have a brief training on guideline of secondary prevention in chd and take a test on that. questionnaires are used to evaluate patient's cognition of their diseases and knowledge on coronary heart disease. patient education will be carried out during a 2 years follow up of all the patient enrolled before they are required to fill out another questionnaire. physicians will also take a second test on secondary prevention of chd at that time. patients will take blood lipids and glucose test according to their physician's requirement.the effect of physician training and patient education will be evaluated by comparing the results of questionnaires and tests at the beginning of the study and in the end of the 2 years follow up.

Eligibility criteria:
inclusion criteria: * diagnosed coronary heart disease * confirmed by coronary angiography; * diagnosed myocardial infarction; * typical symptom of ischemic chest pain with positive stress test; * willing to sign an inform consent. exclusion criteria * patients won't sign an inform consent or will not comply with the follow up.

Keywords: coronary heart disease secondary prevention
dose effect of tranexamic acid on the incidence of deep venous thrombus in cardiac surgery

Conditions: Thromboses, Deep Vein; Tranexamic Acid Adverse Reaction

Summary: in recent years, the lysine analogs tranexamic acid (txa) has gained wide use in cardiac surgery as a blood-sparing agent. however, the safety of the drug and its impact on overall outcomes of cardiac surgery remains debated. the current study evaluates the dose effect of txa on the incidence of deep venous thrombus (dvt) in cardiac surgery with cardiopulmonary bypass. also, the dose effect of txa on bleeding and allogeneic transfusion is evaluated.


Eligibility criteria:
inclusion criteria: * patients receiving selective cardiac surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease * written consent obtained exclusion criteria: * allergy or contraindication to tranexamic acid * severe renal impairment (serum creatinine \>250 μmol/l, or estimated creatinine clearance \<25 ml/min) * thromboembolic disease including but not limited to: history of pulmonary embolism, spontaneous arterial thrombosis or familial hypercoaguability (eg. lupus anticoagulant, protein c deficiency) * thrombocytopenia defined as a platelet count \<100,000/ml * coagulopathy defined as an international normalized ratio \> 1.5 prior to surgery * currently enrolled in another perioperative interventional study * pregnancy or lactation

Keywords: dose effect tranexamic acid deep vein thromboses
to brace or not to brace for single level lumbar fusion pilot

Conditions: Lumbar Spondylosis; Fusion of Spine

Summary: the use of a lumbar brace following single-level lumbar fusion for degenerative spondylosis (non-traumatic) is variable between surgeons. some surgeons prefer to prescribe a brace and others do not. there is a lack of guidelines and evidence to support either treatment option. the purpose of this study is to assess feasibility and collect preliminary data to conduct a larger, definitive trial to provide evidence as to whether prescribing a brace or not results in better or equal outcomes. imaging by ct scan, one year after surgery, will be used to analyze bone fusion (healing), and functional and pain scores from patients during their recovery will be compared to identify differences between patients who wore a brace and those who did not.


Eligibility criteria:
inclusion criteria: * single-level lumbar instrumented postero-lateral fusion from l2-l5 * life expectancy greater than 2 years exclusion criteria: * previous lumbar surgery * spine tumour/cancer * documented osteoporosis * high grade (3 or 4) spondylolisthesis
intervention study to improve maternal handwashing

Conditions: Infection; Neonatal

Summary: the purpose of the handwashing intervention trial is to determine whether an interactive, storytelling approach to promoting handwashing with soap by health care workers can improve mothers' handwashing behavior during the first month of her child's life.

infectious diseases, such as umbilical cord infection, pneumonia, and sepsis, are responsible for about a quarter of neonatal deaths. contaminated hands likely play a role in transmitting pathogens to a neonate, therefore handwashing with soap has the potential to interrupt transmission and improve neonatal health. the primary objective of this study is to develop and evaluate a scalable, cost-effective handwashing promotion program to improve handwashing behavior among mothers and caregivers of neonates. the investigators will first conduct a qualitative study to assess the feasibility and acceptability of a set of interventions. the investigators propose to evaluate the impact of the intervention components, designed as three progressively intense interventions, using a randomized controlled trial with elements of a stepped wedge design. the study will be conducted in meru county, kenya, enrolling a total of 800 pregnant women who seek non-emergency antenatal care at a government health facility during a 1 year period. clinic based health care workers and community health volunteers will disseminate the intervention using an interactive storytelling approach. the focus of the interactions between the health care workers and volunteers and the participant will be on addressing barriers to handwashing through interactive question and answer sessions, rather than a didactic, educational session. the investigators will assess the impact of interventions on observed maternal and caregiver handwashing behavior and estimate the cost effectiveness for each intervention.

Eligibility criteria:
inclusion criteria: * pregnant women * seeking routine (non-emergency) care at a participating antenatal care clinic during the study period * between 30 and 36 weeks pregnant (calculated based on last known menstrual period) when they seek antenatal care * live within 30 minutes or 1-2 km one-way travel from the clinic * plan to remain in the study area for at least one month post-partum * willing to allow the field worker to visit her home following the antenatal care visit on the day of enrollment to conduct baseline assessments at the household * sought antenatal care from a qualified medical provider for the first time at or after 28 weeks gestation exclusion criteria: * excluded if another member of their household or compound/homestead enrolled in this study * excluded if enrolled in the formative research for this study

Keywords: hygiene
fascial manipulation® associated with standard care versus standard post-surgical care for total hip arthroplasty

Conditions: Arthritis

Summary: post-surgical physiotherapy programs following to total hip arthroplasty (tha) show important differences between types and numbers of treatment sessions. objectives are to investigate effectiveness of fascial manipulation when associated to a standard protocol of care.

background. post-surgical physiotherapy programs following to total hip arthroplasty (tha) show important differences between types and numbers of treatment sessions. objectives are to investigate effectiveness of fascial manipulation when associated to a standard protocol of care. methods. fifty-one subjects operated with tha were randomized into two groups, both followed a standard protocol of care where two sessions were replaced with fascial manipulation in the study group. functional outcomes measures collected before and after treatment and at the end of the rehabilitation program included harris hip score, time up and go test, articular range of motion and verbal numerical scale.

Eligibility criteria:
inclusion criteria: * first tha surgery, * posterior-lateral access, * onset of pain of maximum 2 years exclusion criteria: * patients with previous hip or knee prosthesis, * congenital hip dysplasia, * revision tha, * elective tha secondary to trauma, * real leg-length discrepancy (≥1.5cm), * cognitive impairment, * concomitant rheumatic pathology in acute phase, * serious comorbidities including cardiac, * respiratory and/or neuromuscular pathologies.

Keywords: total hip replacement manipulation therapy
retinal redetachment after silicone oil removal : a risk factor analysis

Conditions: Retinal Redetachment After Silicone Oil Removal

Summary: to report the rate of retinal redetachment after silicone oil removal (sor) following rhegmatogenous retinal detachment (rrd) surgery and to determine potential risk factors


Eligibility criteria:
inclusion criteria: * patients with successfully repaired rhegmatogenous retinal detachment and subsequent silicone oil removal * minimum follow-up period of 6 months after silicone oil removal exclusion criteria: * silicone oil tamponade for indications other than rhegmatogenous retinal detachment * retinal redetachment during silicone oil tamponade * prior history of silicone oil tamponade

Keywords: rhegmatogenous retinal detachment silicone oil proliferative vitreoretinopathy
epi-keratoplasty versus collagen cross-linking in progressive keratoconus

Conditions: Progressive Keratoconus

Summary: epi-keratoplasty versus collagen cross-linking in progressive keratoconus

keratoconus is a bilateral corneal ecstatic disease which is not uncommon and always behaves progressively and results in visual impairment by inducing irregular astigmatism and corneal opacities. collagen cross-linking (cxl) is widely used in progressive keratoconus. the cornea is soaked with a riboflavin solution and then being exposed to ultraviolet-a radiation. the performance creates links between collagen fibrils in order to rigidify the corneal stroma and slow down the progression of keratoconus. however, the effectiveness is not satisfied and accompanied with risks of side effects and serious complications, such as pain for the first two post-operative days, temporary loss of visual acuity during the first three months, infection and stromal opacity due to corneal scarring. epi-keratoplasty is a reversible technique in which a corneal graft is transplanted on the recipients' eye with only removal of the epithelium of the receptor cornea. the procedure was assisted by femtosecond laser which allows precisely and neatly cutting. the graft strengths the whole host corneal rigidity and roughness and therefore renders the progression of keratoconus.

Eligibility criteria:
inclusion criteria: * diagnosis of keratoconus * age ≥ 18 years old * corneal thickness ≥ 400 µm * progressive stage 1 to 3 keratoconus (krumeich classification) exclusion criteria: * corneal thickness \< 400µm * concomitant corneal disease * history of corneal surgery

Keywords: keratoconus
effect of virtual reality glasses on pain, anxiety, and comfort during extracorporeal shock wave lithotripsy

Conditions: ESWL; Anxiety; Pain; Comfort; Virtual Reality

Summary: effect of virtual reality glasses on pain, anxiety, and comfort during eswl


Eligibility criteria:
inclusion criteria: being 18 years of age or older, having no hearing or perception impairments, having no visual impairments, undergoing eswl for the first time. exclusion criteria: use of any analgesic or anxiolytic medication before the procedure, having a psychiatric disorder, the procedure being performed on an emergency basis.
transcutaneous photobiomodulation on the control of chilhood anxiety in dental care.

Conditions: Anxiety

Summary: the objective of this study is to investigate whether photobiomodulation helps, collaborates, in the management of the child's anxiety in the dental office.

generalized anxiety disorder (gad) is a chronic psychiatric condition characterized by a widespread and disproportionate concern for adverse life circumstances and the anticipated occurrence of catastrophic and dramatic events. often, the challenges of everyday life, whether potential or real, are feared, as they are expected to increase and lead to irreparable consequences. currently photobiomodulation is a practice used in many areas of health successfully. in the area of anxiety disorders has shown very promising results improving patient behavior. if we understand that photobiomodulation is a non-invasive therapy and with enough evidence of its safety, we must investigate to complement traditional behavioral management techniques. the objective of this study is to investigate whether photobiomodulation (ilib) helps, collaborates, in the management of the child's anxiety in the dental office. the sample will be selected from the assistance centers that have an agreement with ucu, federico ozanam school, san josé college, ucu university health clinic. participants will be randomly distributed into 2 groups: experimental group (g1), control group or placebo (g2) where ilib and placebo will be applied respectively. it will be evaluated in level of anxiety by: facial image scale (fis) and the venham imaging test (vpt) in the conditioned room prior to dental care (16)(17). physiological parameters will also be measured: blood pressure, oximetry, heart rate, pulse, weight, height. ilib applications will be carried out in 2 clinical sessions with an interval between them of at least 48hrs.

Eligibility criteria:
inclusion criteria: children 6 and 12 years old. children who do not consume oral anxiolytics. children who need dental treatment. children whose responsible adults have accepted informed consent. children who have signed a nod of care. exclusion criteria: children who are taking medications that alter the central nervous system ( children with psychiatric or psychological disorders. children with motor disorders such as cerebral palsy. patients who do not fall into the age range of inclusion. patients whose responsible adults do not agree to sign the informed consent. children who do not give their assent to attention.

Keywords: anxiety photobiomodulation
study, double blind, randomized, comparing two groups to evaluate the safety and efficacy of autologous mesenchymal stem cells from adipose tissue (cmmad) in the treatment of the faecal incontinence

Conditions: Faecal Incontinence

Summary: this is a clinical trial phase i/ii, double blind, randomized to compare in two groups of patients to evaluate the safety and efficacy of the autologous mesenchymal stem cells from the adipose tissue (cmmad) in the treatment of the faecal incontinence.

in the phase of recruitment, of 20 months of duration, there will be included 16 participants who will be randomized to one of the groups of intervention (8 patients group cmmad / 8 patients group placebo). the phase of follow-up of every patient will be 12 months, though, provided that these patients are seen regularly in the study sites of the study, once concluded his follow-up will be continued to be able to obtain safety information and efficacy to 24 months.

Eligibility criteria:
inclusion criteria: 1. males or females in the age group of 18-80 yrs. 2. a unique internal sphincter defect and / or external (no more than 100 º), at any level of the anal canal, of any cause (except those described in the exclusion criteria). 3. severity of faecal incontinence of 12 or more in the wexner score and / or at least six episodes of faecal incontinence for a period of 28 days. 4. duration of faecal incontinence of at least two years prior to inclusion. 5. patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent. exclusion criteria: 1. more of an external sphincter defect and / or at any level of internal anal canal. 2. have received treatment to faecal failure with bulking agents, neuromodulation or surgery. 3. current anorectal tumors. 4. current anal fissures. 5. anorectal stenosis 6. chronic pelvic or anorectal pain. 7. pregnant or 6 months postpartum. 8. medical history of infection with human immunodeficiency virus (hiv) or any severe immunocompromised state or therapy immunosuppressive. 9. malignancies in remission for less than a year before the study. an exception to the basocellular carcinoma (bcc) in "remission" for less than a year. 10. bleeding diathesis or current anticoagulant therapy. 11. chemotherapy during the 6 months preceding the study. 12. previous radiation with evidence of radiation injury in the treated area. 13. participation in any other clinical study during the 3 months preceding the pre-study visit. 14. patients with other serious disorders. 15. patients with uncontrolled inflammatory disease or taking drugs prohibited in the protocol or active perianal disease.
pulmonary function substudy for subjects enrolled in studies mkc-ti-161, mkc-ti-162 or mkc-ti-166

Conditions: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate pulmonary function test (pft) sub-study in interested subjects from studies mkc-ti-161, mkc-ti-162 and mkc-ti-166. 100 type i and 100 type ii diabetics will be enrolled. each subject will undergo 6 pft assessments over the course of the parent study.

this study is designed to evaluate and compare changes in pulmonary function (fev1(forced expiratory volume in 1 second) fvc(forced vital capacity), tlc (total lung capacity) and dlco) in subjects enrolled in 1 of 3 parent trials (mkc-ti-161, mkc-ti-162 or mkc-ti-166). up to 100 subjects with type i and type ii diabetes in the ti inhalation powder arm, and 100 subjects with type i and type ii diabetes in the comparator arm will be enrolled. each subject will undergo 6 pft assessments over the course of the parent trial.

Eligibility criteria:
inclusion criteria: * enrollment in one of three parent trials (mkc-ti-161, mkc-ti-162 or mkc-ti-166) exclusion criteria: * subjects who are unable to perform pfts that meet american thoracic society/european respiratory society (ats/ers) quality recommendations for acceptability and repeatability will be excluded from this study
human amniotic epithelial cells prevent acute graft-versus-host disease after hematopoietic stem cell transplantation

Conditions: Acute-graft-versus-host Disease

Summary: this is a single arm clinical study evaluating the safety and efficacy of haecs in preventing agvhd after hsct.

a dose escalation study evaluating the safety and efficacy of human amniotic epithelial cells( haecs) in preventing acute graft-versus-host(agvhd) disease after hematopoietic stem cell transplantation(hsct). the doses were 1×10\^6、2×10\^6、5×\^6 cell/kg, successively.

Eligibility criteria:
inclusion criteria: * standard risk gvhd patients with hematological malignancies; * high risk gvhd patients with hematological malignancies: haplotype hematopoietic stem cell transplantation patients, donor is female or more than 30 years old; * well informed about this study and signed a consent form before the trial; * left ventricular ejection fraction (lvef) ≧ 50%, no evidence of pericardial effusion; * no evidence of lung infection by x-rays examination; * eastern cooperative oncology group (ecog) performance status of 0 or 1, hematopoietic cell transplantation - specific comorbidity index (hct-ci) of 0, 1, 2; * normal liver and kidney function; exclusion criteria: * reduce pretreatment dose or secondary transplantation; * participate other clinical trials within 2 months before this study; * female, 1) pregnant/nursing period, or 2) have a pregnancy plan during the study period, or 3) have fertility and cannot take effective contraception; * history of severe allergic disease or is allergic to one or more drugs; * patients who are considered unsuitable for the study by the investigator.

Keywords: human amniotic epithelial cells(haecs) acute-graft-versus-host disease（agvhd）