Kornimate/medical-research-clean huggingface dataset:
a study of palifermin for the reduction of oral mucositis in subjects with stage 2b or 3 locally advanced, colon cancer

Conditions: Colon Cancer

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of palifermin (recombinant human keratinocyte growth factor, rhukgf) in reducing the incidence of oral mucositis in subjects with stage 2b and 3 locally advanced, colon cancer receiving chemotherapy as an adjuvant treatment for their disease.

this study is being conducted to determine whether administration of a single iv dose of palifermin 3 days before initiation of chemotherapy and 3 days before each subsequent treatment cycle would reduce the incidence of oral mucositis and to evaluate the safety profile in the subject population. this study will evaluate the efficacy of palifermin in reducing the incidence of grade ≥ 2 om in subjects with stage 2b or stage 3 locally advanced, colon cancer undergoing adjuvant chemotherapy with 5-fu and leucovorin in cycle 1. this study will also assess the safety and tolerability of palifermin administered as a single iv dose before each cycle of 5-fu and leucovorin, evaluate the effect of palifermin on patient-reported mouth and throat soreness, the incidence of grade ≥ 2 oral mucositis in cycle 2, the duration of grade ≥ 2 oral mucositis, 5-fu dose reductions/delays and the long-term effects of palifermin on disease outcome and survival.

Eligibility criteria:
inclusion criteria: * history of newly diagnosed histologically confirmed resected colon cancer (american joint committee on cancer \[ajcc\] stage 2b or 3) and a candidate for adjuvant 5-fu and leucovorin * eastern cooperative oncology group performance status ≤ 1 * functional hematopoietic and hepato-renal systems exclusion criteria: * previous therapy (e.g. chemotherapy, radiotherapy or biological therapy) for colon cancer, other than surgical tumor resection * presence or history of any other primary malignancy * presence of active or chronic oral mucositis or xerostomia * previous treatment with other keratinocyte growth factors

Keywords: kgf palifermin oral mucositis clinical trial amgen oncology colon cancer
efficacy of low-dose vonoprazan for helicobacter pylori eradication

Conditions: Helicobacter Pylori Infection

Summary: the primary objective of this retrospective study was to assess the efficacy and safety of a bismuth quadruple regimen of a low-dose potassium-competitive acid blocker versus a standard-dose potassium-competitive acid blocker and a standard-dose proton pump inhibitor combined with amoxicillin and clarithromycin as the initial treatment of helicobacter pylori infection.

helicobacter pylori (h. pylori) infection is closely associated with a variety of diseases including chronic gastritis, peptic ulcer, and gastric cancer. adequate acid suppression is essential for h. pylori eradication therapy. potassium-competitive acid blocker (p-cab) vonoprazan (vpz) has faster, stronger, and longer-lasting acid inhibition and plays an important role in h. pylori treatment. 2022 chinese national clinical practice guideline on helicobacter pylori eradication treatment recommended for the first time a quadruple regimen of bismuth containing p-cab for h. pylori eradication, in which p-cab was administered as vpz 20 mg twice daily. in this retrospective study, we compared the efficacy and safety of a quadruple regimen based on low-dose p-cab (vpz 20 mg once daily) versus a quadruple regimen based on standard-dose p-cab (vpz 20 mg twice daily) or standard-dose proton pump inhibitor (rabeprazole 10 mg twice daily) containing amoxicillin, clarithromycin, and bismuth as initial treatment for h. pylori infection. our study will provide clinical evidence for the necessary dosage of vpz in bismuth quadruple regimens, which will help to further optimize the treatment regimen for h. pylori infection.

Eligibility criteria:
inclusion criteria: 1. diagnosis of h. pylori infection confirmed by urea breath test, monoclonal fecal antigen test, endoscopic biopsy histopathology, or bacterial culture; 2. no previous eradication therapy for h. pylori; 3. age and gender are not restricted. exclusion criteria: 1. use of acid-suppressing drugs within 2 weeks prior to treatment, or use of bismuth or antibiotics (including herbal medicines with antimicrobial properties) within 4 weeks prior to treatment; 2. known hypersensitivity to the drugs used in this study; 3. history of esophageal or gastric surgery; 4. pregnant or lactating women; 5. serious systemic diseases, diseases of the heart, lungs, brain and other vital organs, hepatic or renal insufficiency or malignant tumors (except gastric cancer); 6. patients unable to express their main complaints.

Keywords: helicobacter pylori quadruple regimen vonoprazan
first in human study of tub-030 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors; HNSCC; SCLC; NSCLC; TNBC - Triple-Negative Breast Cancer; CRC

Summary: the goal of this clinical trial is to learn if the drug tub-030 works to treat solid cancer in adults. the study will also explore the safety of tub-030. the main questions it aims to answer are: to determine the safety and tolerability of tub-030 to determine the maximum tolerated dose of tub-030 as a single drug given to patients with solid cancer researchers will also compare doses of tub-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if tub-030 works to treat these two solid cancer types and to determine the best dose. participants will: receive drug tub-030 every 3 weeks visit the clinic once every 3 weeks for checkups and tests answer patient reported outcome questionnaires about their symptoms


Eligibility criteria:
inclusion criteria: 1. male or non-pregnant, non-breastfeeding female aged 18 years or older 2. adequate organ function 3. patients who received anti-cancer treatment including chemotherapy, biological therapy, endocrine therapy, parp inhibitor, or other oral or investigational drugs must have had their last dose at least 4 weeks (6 weeks for nitrosourea, mitomycin-c) or 5 half-lives, whichever is shorter, before c1d1 4. aes related to prior therapy, radiotherapy or surgical procedures must resolve to ≤grade 1. 5. for patients with known brain metastases, evidence of clinically stable disease post radiation therapy is required prior to enrollment. 6. for patients who underwent radiotherapy (≥ 30% of the bone marrow or wide field) to sites outside the brain, the final dose of radiation must have been administered ≥ 28 days prior to c1d1. for patients who underwent palliative radiotherapy (≤ 30% of the bone marrow or wide field) the final dose of radiation must have been administered ≥14 days prior to c1d1. 7. radiologically measurable disease by recist v1.1, 4 weeks before c1d1, that can include a lesion in an irradiated field that shows progression according to recist v1.1 after irradiation. 8. eastern cooperative oncology group (ecog) 0-1. 9. have a life expectancy of \>12 weeks for disease-related mortality, as evaluated by the inv. 10. in the opinion of the inv, the patient must be able and willing to understand and give signed informed consent 11. women of childbearing potential (wocbp) who are sexually active with a non-sterilized partner must use at least 1 highly effective method of contraception (with a failure rate of 1% per year) from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of patients of childbearing potential patients must agree to continue a highly effective contraceptive method, refrain from egg cell donation and breastfeeding while on study treatment and for 5 half-lives plus 6 months after the last dose of study treatment. exclusion criteria: -

Keywords: advanced solid tumors nsclc head and neck cancer
advance targeted transfusion in anemic cardiac surgical patients for kidney protection: a proof of concept pilot study

Conditions: Kidney Injury

Summary: one of the major complications of heart surgery is kidney injury, which occurs in up to 30% of patients and is associated with poor outcomes including death. we have found that patients whose hemoglobin concentration before surgery is lower than normal (i.e., are anemic) are at particularly high risk for this complication, likely because their hemoglobin concentration drops to very low levels during surgery, which reduces delivery of oxygen to the kidneys, increases blood loss, and necessitates blood transfusions. we and others have shown that these events are individually harmful to the kidneys, and can lead to kidney injury. we believe that we can prevent these events from occurring, and as a result reduce the risk of kidney injury, if we transfuse anemic patients at least 1 day before surgery rather than during surgery. in anemic patients undergoing cardiac surgery, prophylactic transfusion of red blood cells (rbcs) before surgery will reduce the risk of acute kidney injury (aki) after surgery by mitigating three inter-related risk factors for aki.


Eligibility criteria:
inclusion criteria: * patients undergoing non-emergent aortocoronary bypass (acb) surgery, or valve surgery, combined acb and valve, or aortic root repair requiring cpb with a preoperative hb concentration between 100 and 120 g/l. exclusion criteria: * any conditions that may limit the ability of patients to tolerate the intervention: * severe aortic or mitral valve stenosis * history of congestive heart failure within 30 days of surgery or severe ventricular dysfunction (ejection fraction \< 30%) * severe (\> 60%) left main coronary artery stenosis or unstable angina within 30 days of surgery

Keywords: anemia cardiac surgery rbc transfusion acute kidney injury cardiac surgery with cardiopulmonary bypass
deep brain stimulation of the subthalamic nucleus (stn) and cognitive control

Conditions: Parkinson's Disease

Summary: in this study, the investigators will follow patients who have had stimulators implanted, at their usual clinic follow-up appointments 3, 6, 9 and 12 months after surgery. it is typical at these appointments for patients to be off medication and for the stimulators to be turned off to observe disease progress and test stimulator effectiveness. also as part of standard clinical practice, stimulator settings are adjusted for optimal benefit to motor symptoms. only patients who already have implants will be invited to participate in this study, and no changes to stimulator settings are made for the purposes of this study. stimulator settings are changed based on clinical evaluation of motor symptoms, and this study has no bearing on how stimulators will be set nor how often they will be set.


Eligibility criteria:
inclusion criteria: * meet criteria for "definite" parkinson's disease (pd) * stn stimulators on both sides (right and left) * surgery done at washington university within 2 years exclusion criteria: * significant visual deficits (e.g. double vision, untreated eyelid apraxia, blepharospasm) must be able to see screen * secondary parkinsonism (drug-induced or other known etiologies) * brain injury or defect: history of serious head injury, stroke, encephalitis, defect found on brain imaging * early severe dementia (within first year of onset) or on cholinesterase inhibitors * pre-surgical mini mental status exam score \< 24 * significant current psychiatric diagnoses (such as depression or psychosis) or on neuroleptics

Keywords: parkinson's disease stn dbs deep brain stimulation
telerehabilitation dual-task training for parkinson's: a multidimensional evaluation

Conditions: Parkinson Disease

Summary: in this clinical study, the aim is to assess the effectiveness of telerehabilitation-based dual-task training in improving balance and gait function among individuals diagnosed with parkinson's disease. parkinson's disease is characterized by motor symptoms such as tremors and slowness of movement, as well as cognitive impairments. while medical treatments help manage symptoms, exercise programs are vital for enhancing physical and cognitive functions. dual-task training involves combining motor and cognitive activities to enhance gait and balance control, and recent studies have shown its effectiveness in parkinson's disease rehabilitation. however, there's limited research on delivering dual-task training through telerehabilitation and determining the optimal content for maximum benefits. this project involves 30 parkinson's disease patients who will be randomly assigned to three groups receiving different dual-task exercise programs via telerehabilitation. each program focuses on combining balance and functional exercises with either cognitive or motor secondary activities. the exercises will be performed three times a week for four weeks under the guidance of a physiotherapist via zoom. before and after the intervention, participants will be evaluated for feasibility, gait, balance, cognition, and activity levels. researchers of this study hypothesize that telerehabilitation-based dual-task training will significantly improve balance and gait function in parkinson's disease patients, offering a convenient and effective treatment option to enhance their quality of life.


Eligibility criteria:
inclusion criteria: * diagnosed with idiopathic parkinson's disease * stage 1-3 on the hoehn-yahr scale * a minimum score of 21 on the montreal cognitive assessment scale test * stable drug treatment within the last 1 month * patients are in the "on" period * ability to walk independently on level ground (3 and above according to functional ambulation classification) exclusion criteria: * serious hearing or vision problems * having other neurological, cardiovascular or orthopaedic disorders that may prevent walking * any other neurological disorder (e.g. dementia, cerebrovascular disease) * less than 5 years of education * to have vascular lower extremity pathologies * not having internet access via smartphone or computer
social media-based electronic bibliotherapy for dementia caregivers

Conditions: Mental Health; Quality of Life; Dementia Caregivers

Summary: this study aims to assess the efficacy of social media-based electronic bibliotherapy in improving the well-being of informal caregivers of people with dementia compared to a control group.

this randomized controlled trial aims to assess the efficacy of social media-based electronic bibliotherapy in improving the well-being of informal caregivers. sixty informal caregivers of people with dementia were recruited and randomly allocated to the social media-based electronic bibliotherapy group or usual care group. participants in the social media-based electronic bibliotherapy group received eight weekly e-bibliotherapy sessions. the control group only accepted the usual care provided by community services, but they received the same intervention materials as the intervention group after project completion. mental health, caregiving appraisal, health-related quality of life, and psychological well-being were measured to test the intervention's effects immediately after completion. individual interviews were conducted to explore caregivers' experiences participating in this study within two weeks after completing the intervention.

Eligibility criteria:
inclusion criteria: * caregivers providing regular care to individuals with mild to moderately severe dementia (global deterioration scale=4\~6 of any type), requiring at least five hours per week for a minimum duration of six months; * aged 18 or above; * not receiving payment for caregiving services rendered; * assisting with at least one daily activity of the care recipient; * possessing reading ability; * utilized social media platforms such as whatsapp, facebook, twitter, instagram, and wechat for over six months. exclusion criteria: * caregivers with unstable physical or mental conditions; * caregivers unable to communicate logically; * involvement in another interventional study
aerobic interval training in patients with chronic obstructive pulmonary disease (copd) and hypoxemia

Conditions: Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Hypoxia

Summary: patients with severe chronic obstructive pulmonary disease (copd) and low oxygen levels in the blood are at risk of developing pulmonary hypertension and strain on the right side of the heart, both of which are known to increase symptoms and worsen prognosis it is not fully established whether interval exercise training in patients with severe copd and concomitant low oxygen levels is beneficial. this study aims to evaluate the effects of aerobic interval exercise training in patients with severe copd and low oxygen levels in the blood, with a particular emphasis on such effects on the cardiovascular system and pulmonary circulation.


Eligibility criteria:
inclusion criteria: * chronic obstructive pulmonary disease (copd) * forced expiratory volume 1 second (fev1) \<60% of predicted * fev1%fvc \<70 % of predicted (fvc = forced vital capacity) * qualify for long term oxygen therapy (ltot), or presence of significant desaturation on exercise. exclusion criteria: * unstable ischaemic heart disease or valvular heart disease. * active malignant disease. * substance abuse. * physical or mental disability that prevents participation in the exercise programme or testing. * pregnancy. * exacerbation of copd or respiratory tract infection last 6 weeks before. * completed pulmonary rehabilitation programme or other organised exercise programme last 3 month * use of high doses of systemic steroids.

Keywords: exercise therapy
role of intraoperative ultrasound in gastrointestinal (gi) malignancies

Conditions: Ultrasonography; Gastrointestinal Disease; Malignancy

Summary: currently available investigating modalities like ct scans, mri etc although have a high accuracy in staging of gastrointestinal(gi) tract malignancies, are not correct in all cases . the aim of this study is to assess the role of intraoperative ultrasound as a modality to increase the staging accuracy of gi tract malignancies


Eligibility criteria:
inclusion criteria: * patients with gi tract malignancies exclusion criteria: * patients who refuse consent

Keywords: intraoperative ultrasound gi tract malignancies modality ultrasound staging modality
effects of pneumococcal vaccine on nasopharyngeal carriage

Conditions: Nasopharyngeal Carriage of Streptococcus Pneumoniae

Summary: the purpose of this study is to assess the direct effects of the ten-valent pneumococcal conjugate vaccine administered to infants on nasopharyngeal carriage at 3 to 5 years of age. these children have been vaccinated in infancy in the cluster-randomized finnish invasive pneumococcal disease (finip) trial (a separate protocol reported at clinicaltrials.gov identifier:nct00861380) during 2009 to 2011. also the indirect effect on nasopharyngeal carriage will be assessed on vaccinees' elder non-vaccinated siblings aged 5 to 9 years.

this study includes a cross-sectional sampling of nasopharyngeal and oropharyngeal swabs in 2013 from vaccinated and unvaccinated children.

Eligibility criteria:
inclusion criteria for finip-vaccinated children: 1. age 3 to 5 years 2. enrolled in the finip trial and has received at least one dose of study vaccine in the infant vaccine schedule (3+1 or 2+1) 3. at least one parent with fluent finnish 4. informed consent from one parent exclusion criteria for finip-vaccinated children 1. pcv vaccination administered, other than the randomized study vaccine 2. history of antimicrobial treatment within 4 weeks (the child can be enrolled later) inclusion criteria for unvaccinated siblings 1. age 5 to 9 years 2. younger sibling living in the same household having participated in the finip trial (regardless of the vaccination schedule) 3. at least one parent with fluent finnish 4. informed consent from one parent exclusion criteria for unvaccinated siblings 1. pcv vaccination administered 2. history of antimicrobial treatment within 4 weeks (the child can be enrolled later)
study of the effects of intensive treatment of periodontitis on blood pressure control

Conditions: Periodontitis; Hypertension

Summary: hypertensive patients with chronic periodontitis will be randomized to either intensive treatment or supragingival hygienic treatment and the effects on blood pressure will be identified.


Eligibility criteria:
inclusion criteria: * periodontitis with three or more periodontal pockets with a probing depth (pd) \> 5mm * bleeding of these periodontal pockets on probing * have at least 20 natural teeth * provide informed consent and willingness to cooperate with the study protocol * age \>25 years old * absence of other significant oral infections. * primary hypertension on stable treatment exclusion criteria: * clinical symptoms of acute inflammatory disorders incl flu, rhinitis, sinusitis etc. within past 3 weeks * hospitalization for any reason within the past 3 months; life expectancy of \< 3 years; * allergic disorders; history of chronic infectious disease, chronic obstructive pulmonary disease (copd), tuberculosis; chronic hepatitis b or c infection; interstitial pneumonitis, bronchiectasis; known chronic pericardial effusion, pleural effusion, or ascites; liver disease; * other known chronic inflammatory or autoimmune condition such as lupus or rheumatoid arthritis, ulcerative colitis or crohn's disease * secondary hypertension (known plasma renin screening, abdominal ultrasound with doppler and other investigations) * non-basal cell malignancy or treated myelo or lymphoproliferative disease within the past 5 years; * known hiv positive; immunizations within past 3 months * individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea. * primary pulmonary hypertension. * use of systemic or local steroids or immunosuppressive agents within 6 months of the inclusion. * individual is pregnant or nursing * history of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week
comparing mri-ultrasound fusion and cognitive-guided biopsy for the detection of cspca: the profusion trial

Conditions: Prostate Cancer

Summary: this study is an international multicentre rct to compare the linically significant prostate cancer (cspca) detection of cognitive-guided and mri-usg guided biopsies in men with suspicious mri lesion.

this study is an international multicentre rct to compare the cspca detection of cognitive-guided and mri-usg guided biopsies in men with suspicious mri lesion. this is a phase iii randomised controlled trial to evaluate the detection of clinically significant prostate cancer (cspca) by mri-usg fusion approach (mrus arm) versus cognitive-guided approach (cog arm). the study hypothesis is that mrus arm is superior to cog arm in detecting cspca. the result of this rct would impact how mri-guided prostate biopsies should be done in the future. if the mri-usg fusion approach is superior to cognitive-guidance in cspca detection, it should be the standard of practice in the future, and dedicated mri-usg fusion equipment should be available in centres performing prostate biopsies.

Eligibility criteria:
inclusion criteria: * men ≥18 years of age * clinical suspicion of prostate cancer and indicated for prostate biopsy * serum prostate-specific antigen (psa) \< 20 ng/ml * digital rectal examination ≤ ct2 (organ-confined cancer) * able to provide written informed consent * mri prostate (contrast or plain) showing 1-3 suspicious lesion(s) with pi-rads score 3-5 exclusion criteria: * prior prostate biopsy in the 2 years before screening visit * prior diagnosis of prostate cancer * contraindicated to prostate biopsy: active urinary tract infection, failed insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (continue low-dose aspirin before and after biopsy is permitted) * patient refusal for biopsy