Kornimate/medical-research-clean huggingface dataset:
a critical pathway for implantable cardioverter-defibrillators in patients with ischemic cardiomyopathy

Conditions: Myocardial Infarction; Heart Failure

Summary: the purpose of this study is to develop and implement a critical pathway to identify patients with ischemic cardiomyopathy who are candidates for an implantable cardioverter-defibrillator (icd). this study will also determine whether the use of the critical pathway for icds is associated with a change in the icd referral and implantation rate.

despite improvements in both medical management and revascularization strategies, sudden death is still a significant complication in patients with ischemic cardiomyopathy. there is strong evidence to support the role of icds for the primary prevention of sudden death in this population. however, in canada and the united states, icds are underutilized. critical pathways are algorithms that improve health care delivery and clinical outcomes while reducing practice variability. the use of a critical pathway to assess a patient's eligibility for an icd may increase the appropriate use of this evidence-based technology.

Eligibility criteria:
inclusion criteria: * acute st segment elevation myocardial infarction (stemi) * candidate for percutaneous revascularization * permanent residents of british columbia, canada exclusion criteria: * patients with heart disease or a comorbid illness who have a documented life expectancy of less than 1 year

Keywords: myocardial infarction heart failure sudden cardiac death critical pathways
the effects upon the bladder of transcutaneous tibial nerve stimulation in acute traumatic spinal cord injury

Conditions: Spinal Cord Injury; Neurogenic Bladder

Summary: the purpose of this research study is to evaluate the effects upon the bladder of electric stimulation of the leg's tibial nerve in people with acute spinal cord injury with an intervention called transcutaneous tibial nerve stimulation (ttns).

in this study, ttns will be used to help neurogenic bladder in sci. first, acute sci subjects which respond to ttns will be identified as seen on urodynamic studies (usd). then, responders will be invited to participate in a randomized control trial of a 2-week protocol of ttns to test for safety and efficacy during inpatient rehabilitation to evaluate bladder changes based upon pre- and post- urodynamic testing, as well as 2-month follow-up.

Eligibility criteria:
inclusion criteria: * enrollment within 6 weeks of injury * neurologic level rostral to t10 (t9 and above). this is a significant neurologic level because the bladder remains innervated at these levels, without damage to the nerve cell bodies of the bladder within the spinal cord. * location and transportation available for follow-up appointments exclusion criteria: * history of peripheral neuropathy or premorbid symptoms of peripheral neuropathy * known etiologies that may cause peripheral neuropathy (i.e. diabetes mellitus, hypothyroidism, autoimmune diseases, alcoholism, hx of chemotherapy, etc.) * history of genitourinary diagnoses (i.e. prostate hypertrophy, overactive bladder, cancer, etc.) * pregnancy * history of central nervous system disorder (i.e. prior sci, stroke, brain injury, parkinson's disease, ms, etc.) * morbid obesity * ventilator dependent respiration * significant autonomic dysreflexia during baseline urodynamic study.

Keywords: electric stimulation urodynamic study
a study of first-line js001 and nab-paclitaxel versus palcelbo and nab-paclitaxel in participants with advanced recurrent or metastatic tnbc

Conditions: Triple Negative Breast Cancer

Summary: this multicenter, randomized, double-blind study will evaluate the efficacy, safety of js001 administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel as first-line therapy in participants with primarily diagnosed stage iv and recurrent or metastatic triple-negative breast cancer (tnbc) who have not received prior systemic therapy for metastatic breast cancer (mbc).


Eligibility criteria:
inclusion criteria: 1. primarily diagnosed stage iv or recurrent and metastatic, histologically documented tnbc characterized by absence of human epidermal growth factor 2 (her2), estrogen receptor (er), and progesterone receptor (pr) expression; 2. no prior chemotherapy or targeted systemic therapy for inoperable stage iv or metastatic tnbc； 3. eligible for taxane monotherapy； 4. eastern cooperative oncology group performance status of 0 or 1； 5. measurable disease as defined by recist v1.1； 6. adequate hematologic and end-organ function。 exclusion criteria: 1. known central nervous system (cns) disease with active syndrome or untreated disease, except for treated asymptomatic cns metastases； 2. history of autoimmune disease； 3. history of anaphylaxis to pd-(l)1 antibody or ctla-4 antibody or paclitaxel; 4. prior allogeneic stem cell or solid organ transplantation; 5. active hepatitis b or hepatitis c; 6. positive of hiv antibody.
internet-based cbt after stroke pilot

Conditions: Stroke; Depression

Summary: mood disorders occur in 25-30% of stroke patients and are associated with lower quality of life, higher mortality, increased healthcare utilization, and higher costs. cognitive behavioral therapy (cbt) interventions have been shown to both treat and prevent post-stroke mood disorders, thus having the ability to improve quality of life and reduce costs. this study aims to test the feasibility of internet-based cbt combined with a telephone/email based coaching service after stroke.


Eligibility criteria:
inclusion criteria: * age ≥18 years of age * acute ischemic stroke within the past 3 months * regular access to the internet, sufficient to allow a minimum of interactions with the internet daily, either through a personal smartphone or web-based internet browser. * subject is willing and able to participate in internet-based cognitive behavioral therapy * can participate in the program in english * willingness and ability to sign informed consent by the patient * symptoms of mild to moderately depressed mood, defined as a score of 5-19 on the patient health questionnaire-9 at the time of study enrollment. exclusion criteria: * severely depressed patients, defined by a score of 20+ on the patient health questionnare-9 are excluded * patients with an active bipolar disorder diagnosis are excluded * patients with personality disorder diagnoses are excluded * patients with active suicidality or past suicide attempts are excluded * history of schizophrenia or schizoaffective disorder * active participation in face-to-face psychotherapy prior to stroke * patients with a history of dementia are excluded * patients with aphasia, defined as a score of 1 or greater on nih stroke scale item 9 are excluded. * patients without regular internet access through a computer, tablet or smartphone are excluded. * subjects requiring long-term inpatient nursing care are excluded. for patients enrolled as inpatients, individuals being discharged to both home and acute rehab are eligible. individuals being discharged to a skilled nursing facility or hospice are excluded. * expected life expectancy less than 6 months or other inability to comply with study follow-up. * pregnant women and prisoners are excluded
a study of shr-a2009 versus platinum-based chemotherapy in egfr-mutated, advanced or metastatic nsclc

Conditions: Non-small Cell Lung Cancer

Summary: this study was a randomized, controlled, open-label, multicenter phase iii clinical study to compare the efficacy and safety of shr-a2009 with platinum-based dual-agent chemotherapy in patients with egfr-mutated advanced or metastatic non-small cell lung cancer who failed egfr tki treatment.


Eligibility criteria:
inclusion criteria: 1. age 18 to 75 years old (inclusive), female or male 2. subjects with unresectable locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology 3. previously treated by egfr-tki； 4. at least one measurable tumor lesion according to recist v1.1 5. ecog performance score of 0-1; 6. expected survival time ≥ 12 weeks; 7. adequate bone marrow and organ function 8. subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form. exclusion criteria: 1. subjects with active central nervous system (cns) metastases. 2. received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug; 3. received \>30 gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug; 4. major organ surgery or significant trauma within 4 weeks prior to first use of study drug; 5. concomitant other malignancies ≤ 5 years prior to first dose of study drug; 6. subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function 7. serious cardiovascular disease 8. presence of severe infection within 4 weeks prior to first dose of study drug 9. arterial/venous thrombotic events within 3 months prior to the first study dose 10. history of immunodeficiency, including a positive hiv test 11. presence of active hepatitis b or c; 12. history of allergic reactions to any component of study treatment or severe allergic reactions to other monoclonal antibodies.
a study to evaluate the safety, tolerability of hh-003 injection in participants with chronic hepatitis b virus infection

Conditions: Chronic HBV Infection

Summary: this is a multicenter, randomized, double-blind, placebo-controlled, multiple-ascending dose phase ib study of hh-003 injection, which is a monoclonal antibody targeting hepatitis b virus. this study aims to evaluate the safety, tolerability and pharmacokinetics of hh-003 injection in treatment-naive participants chronically infected with hepatitis b virus.


Eligibility criteria:
inclusion criteria: * 18 to 45 years old * body weight ≥ 45 kg for men and ≥ 40 kg for women, and 18 kg/m\^2≤bmi≤28 kg/m\^2 * positive serum hbsag or hbv dna for at least 6 months,or previous liver biopsy results confirm the hepatitis b * hbeag positive, and 2000 iu/ml\<hbsag\<100,000 iu/ml * have not received interferon treatment before, and have not received nucleotide/nucleoside analogue treatment within 6 months prior to screening exclusion criteria: * positive test for hepatitis c antibody (hcv-ab), treponema pallidum antibody (tp-ab), or anti-hiv antibody (hiv-ab) * hemoglobin \<100 g/l, platelets \<100,000/mm\^3 (100×10\^9/l), absolute neutrophils count \<1,500/mm\^3 (1.5×10\^9/l) * serum albumin \ 1.5; serum creatinine \>115 μmol/l, glomerular filtration rate (gfr) \ 540 μmol/l; triglyceride\>3.5mmol/l * participants with a history of alcoholic liver disease, moderate or higher nonalcoholic fatty liver disease, autoimmune liver disease, gilbert syndrome or other hereditary liver disease, drug-induced liver disease and other chronic liver diseases * participants with a history of progressive liver fibrosis (eg: liver cirrhosis diagnosed by liver histopathological examination, or esophagogastric varices diagnosed by endoscopy) * participants with confirmed or suspected decompensated hbv cirrhosis with complications of ascites, hepatic encephalopathy, gastroesophageal variceal bleeding, and child-pugh score of b\~c, or with primary liver cancer * alpha fetoprotein (afp) \>50 ng/ml at screening or the suspected malignant liver mass indicated by imaging * any previous or current malignant neoplasms * breast-feeding or pregnant females * participants who are not suitable to participate in this trial per the investigator's judgment
the impact of different recovery positions on the perfusion of the lower forearm and comfort

Conditions: Unconsciousness

Summary: introduction: a side-lying recovery position is recommended when victims are unresponsive but breathing normally and, hence, do not require cardiopulmonary resuscitation. in 2021, the european resuscitation council (erc) and the belgian red cross-flanders issued new guidelines which included the description of a modified recovery position to avoid problems in victims with joint stiffness and to overcome potential obstructed venous return in the dependent arm. based on good practice insights, the dependent arm will now be extended and not bent to support the other arm. however, there is currently no evidence available to support a specific recovery position. objectives: the aim of this study is to assess the impact of different recovery positions on perfusion of the forearm and associated comfort. methods: in this cross-over randomized controlled trial, 24 healthy volunteers will be placed in either the lateral recovery position with extended dependent arm or with bent arm, and in the other position thereafter. before and between both recovery positions, the volunteers will be positioned supine for 15 min. several perfusion indices of the forearm will be non-or mildly invasively monitored in the respective recovery positions by radial artery tonometry, ulnar artery echo doppler and venous congestion plethysmography. subjective participant's discomfort and pain will be assessed as well. differences in continuous outcomes between the different recovery positions will be assessed with paired t-tests or wilcoxon signed-rank test. discussion: the benefit of lateral positioning of adults and children with decreased level of consciousness has been widely accepted despite limited supportive scientific evidence. we here will provide direct evidence (i) whether venous drainage in the dependent limb is impaired when positioning the victim in the lateral recovery position with bent arms and (ii) whether this potential complication can be minimized by extending the dependent arm. the major limitations of this study is that healthy volunteers, instead of non-responsive victims, are included as participants, and that the study will be performed in a highly controlled environment. nevertheless, the generated insights will directly fuel evidence-based treatment recommendations regarding the recovery position in first aid settings, and fill a current gap in evidence.


Eligibility criteria:
inclusion criteria: -healthy volunteers exclusion criteria: * history of any coronary or peripheral vascular disease such as raynaud's disease or thromboangitis obliterans (self-declared) * type i or type ii diabetes (self-declared) * intake of cholesterol-lowering medication (self-declared) * high blood pressure (systolic blood pressure \> 140 mmhg and/or diastolic blood pressure \> 90 mmhg) and/or use of antihypertensive drugs (self-declared) * obesity (bmi \> 30 kg/m2) * smoking or using tobacco products (self-declared)

Keywords: recovery position first aid for unconsciousness arterial flow
weekly paclitaxel/carboplatin/bevacizumab as first line therapy for triple negative breast cancer

Conditions: Breast Cancer

Summary: this study will evaluate the efficacy of weekly paclitaxel-carboplatin combination plus bevacizumab as first line treatment in patients with metastatic triple negative breast cancer. furthermore, the efficacy of the combination therapy will be correlated with the presence of circulating tumor cells (ctcs) in this population

breast cancer with absent or low expression of hormone receptors and her2 (triple negative) does not respond to hormonal or biological therapy with trastuzumab. however, triple negative breast cancers are highly sensitive to chemotherapy. the combination of paclitaxel and carboplatin administered on a weekly basis is active and well tolerated. recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed metastatic breast adenocarcinoma * no her2 overexpression or gene amplification * absent or low er or pr expression * no previous therapy for metastatic breast cancer is allowed * age 18-75 years * measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions) * performance status (who) 0-2 * adequate liver (serum bilirubin \<1.5 times the upper normal limit, ast and alt \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases) * adequate renal function (serum creatinine \<1.5 times the upper normal limit) * bone marrow (neutrophils ≥ 1.5x 109 /l, and platelets ≥ 100x 109 /l) * no radiation of measurable disease (except brain metastases) * no progressive brain metastases according to clinical or radiological criteria * no brain metastases without prior radiation therapy * written informed consent exclusion criteria: * active infection * history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) * history of stroke * anticoagulation therapy (except of low dose aspirin \<325mg) * other invasive malignancy except nonmelanoma skin cancer * psychiatric illness or social situation that would preclude study compliance * pregnant or lactating women

Keywords: breast cancer triple negative chemotherapy anti-angiogenesis therapy
the relationship between delirium and bdnf in coronary artery bypass graft surgery

Conditions: Delirium - Postoperative; BDNF; CABG

Summary: this study is aimed at finding a correlation between postoperative delirium occurrence, severity and duration after cardiac surgery and the level of brain-derived neurotrophic factor (bdnf) in plasma as a marker of brain injury induced by cardio-pulmonary by-pass and its association with genetic predisposition in patients undergoing coronary artery bypass grafting (cabg) carrying bdnf gene polymorphism (val66met).


Eligibility criteria:
inclusion criteria include: 1. age \> 18 years. 2. planned coronary artery bypass grafting (cabg) procedure with the use of cardiopulmonary by-pass (cpb). 3. ability to understand and sign an informed consent form. exclusion criteria include: 1. emergency surgery. 2. previous known cognitive disorders: mini mental state examination (mmse) score \<15. 3. baseline delirium (positive cam test prior to surgery). 4. diagnosis of psychiatric syndromes in the past - i.e. depression, dementia, psychosis or schizophrenia. 5. inability to understand polish language. 6. inability to give and sign informed consent due to auditory or visual dysfunction.
short-term treatment satisfaction in hidradenitis suppurativa patients initiated on cosentyx in routine clinical practice in saudi arabia

Conditions: Hidradenitis Suppurativa (HS)

Summary: this study aims to assess the treatment satisfaction of hs patients newly started on secukinumab in saudi arabia, in terms of patient reported convenience, perceived safety, perceived effectiveness and global treatment satisfaction as measured by the treatment satisfaction questionnaire for medication (tsqm) at week 24 among moderate to severe hs patients.

this is a 24-week longitudinal single arm prospective study based on data collected from electronic medical records (emrs) and patient-reported outcomes questionnaires (tsqm, dlqi, and nprs-11) to evaluate patient-reported satisfaction and early qol experiences among hs adult patients who are newly administering secukinumab as per routine clinical practice. data will be captured from both data sources (emrs and questionnaires) at the following time points (+/- 1 month): * baseline (index date: initiation of secukinumab), * 24 weeks. this is in line with the frequency of routine follow-up visits and as per the standard of care to report on pre-defined outcomes in a representative hs population across saudi arabia.

Eligibility criteria:
inclusion criteria: 1. male or female adult patients ≥18 years of age at the time of data collection. 2. patient with a confirmed diagnosis of active moderate to severe hs. 3. secukinumab naive patients (first dose to coincide within one month of the signature of the informed consent) as per locally approved label. 4. patients can be using antibiotics or have undergone surgery as per routine clinical practice. 5. patients agree to sign an informed consent form (icf) to be able to complete the questionnaires. exclusion criteria: 1. patients not fulfilling any of the above-mentioned inclusion criteria. 2. patient's refusal to be included in the study or refusal to sign the icf. 3. a history of off-label indication uses of biological treatment or jak inhibitor.

Keywords: hidradenitis suppurativa hs secukinumab nis saudi arabia
evaluation of reactogenicity and safety of gsk biologicals' rotarix™ (human rotavirus vaccine) in infants

Conditions: Infections, Rotavirus

Summary: this post marketing surveillance (pms) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose).


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol . * a male or female at least 6 weeks of age at the time of the first vaccination. * written informed consent obtained from the parent or guardian of the subject. exclusion criteria: * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * acute disease at the time of enrolment. * any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception. * any contraindication as stated in the updated and approved prescribing information

Keywords: gastroenteritis
study of osteopathic manipulation in the management of angina

Conditions: Angina Pectoris

Summary: the purpose of this study is to assess the effectiveness of osteopathic manipulation in decreasing angina pectoris symptoms.


Eligibility criteria:
inclusion criteria: * canadian cardiovascular society class ii, iii for a minimum of 6 months * documented coronary artery disease via previous myocardial infarction, abnormal stress test, or abnormal coronary angiogram of greater than or equal to 50% luminal obstruction of at least one epicardial vessel. exclusion criteria: * severe left ventricular dysfunction * symptomatic heart failure * symptomatic aortic stenosis or any valvular disease * significant pulmonary disease * unstable angina * major surgery or angioplasty in the past three months * acute myocardial infarction within past three months * insulin dependent diabetes mellitus * uncontrolled hypertension * acute renal or hepatic failure * currently being treated with osteopathic manipulation

Keywords: angina pectoris, osteopathic manipulation