Kornimate/medical-research-clean huggingface dataset:
a dose-escalation study for patients with advanced cancer

Conditions: Advanced Cancer

Summary: this study is being conducted to determine the safety of ly2523355 for the treatment of advanced and/or metastatic cancer (including non-hodgkin's lymphoma).

this study is a multi-center, non-randomized, open label, dose-escalation, phase 1 study of intravenous ly2523355 in patients with advanced and/or metastatic cancer (including non-hodgkin's lymphoma) for whom no treatment of higher priority exists.

Eligibility criteria:
inclusion criteria: * have a diagnosis of advanced and/or metastatic cancer (solid tumors or non-hodgkin's lymphoma) that is refractory to standard therapy or for which no proven effective therapy exists. participants entering the dose confirmation phase (part b) of the study must also have a tumor that is safely amenable to serial biopsies * have the presence of measurable or nonmeasurable disease as defined by the response evaluation criteria in solid tumors (recist) or revised international working group lymphoma response criteria * have a performance status of 0 or 1 on the eastern cooperative oncology group (ecog) scale * have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 28 days (6 weeks for mitomycin-c or nitrosoureas) prior to study enrollment * males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug * females with child bearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug * have an estimated life expectancy of greater than or equal to 12 weeks. exclusion criteria: * have symptomatic, untreated or uncontrolled central nervous system (cns) metastases. participants with treated cns metastases are eligible provided their disease is radiographically stable, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. screening of asymptomatic participants without history of cns metastases is not required * have current acute or chronic leukemia * have had an autologous or allogenic bone marrow transplant * females who are pregnant or lactating

Keywords: advanced cancer cancer
acalabrutinib study with best supportive care versus best supportive care in subjects hospitalized with covid-19.

Conditions: COVID-19

Summary: calavi will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with best supportive care in the treatment of covid-19.


Eligibility criteria:
inclusion criteria: 1. ability to understand the purpose and risks of the study and provide signed and dated informed consent or have a legal representative provide consent and authorization to use protected health information (in accordance with national and local patient privacy regulations) 2. men and women ≥18 years of age at the time of signing the informed consent form 3. confirmed infection with sars-cov-2 confirmed per world health organization (who) criteria (including positive rt-pcr nucleic acid test of any specimen \[eg, respiratory, blood, urine, stool, or other bodily fluid\]) within 4 days of randomization 4. covid-19 pneumonia (documented radiographically) requiring hospitalization and oxygen saturation \<94% on room air or requires supplemental oxygen 5. able to swallow pills 6. willing to follow contraception guidelines exclusion criteria: 1. respiratory failure at time of screening due to covid-19 2. known medical resuscitation within 14 days of randomization 3. pregnant or breast feeding 4. suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with sars-cov-2) 5. alanine aminotransferase (alt), aspartate aminotransferase (ast) and/or bilirubin ≥ 3x upper limit of normal (uln) and/or severe hepatic impairment detected within 24 hours at screening (per local lab) 6. uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (nyha grade 3 or 4). exception: subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll 7. treatment with a strong cytochrome p450 (cyp)3a inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 8. requires treatment with proton-pump inhibitors (ppis; eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). subjects receiving ppis who switch to h2-receptor antagonists or antacids are eligible for enrollment in this study 9. received oral antirejection or immunomodulatory drugs (eg, anticytokines, btk inhibitors, jak inhibitors, pi3k inhibitors) within 30 days before randomization on study

Keywords: 2019 novel coronavirus disease acalabrutinib btk inhibitor
advanced refractory solid tumors with tp53 mutations register study

Conditions: Solid Tumor, Adult

Summary: the efficacy and safety of the parp inhibitor in combination with the vegfr inhibitor will be investigated in advanced refractory solid tumors patients with tp53 mutation .

tp53 is a well-known tumor suppressor gene. multiple studies have demonstrated that tp53 mutations are poor prognostic factor in advanced solid tumor, the tp53 gene is frequently inactivated by mutation in a majority of human tumors. however, no effective tp53 -based therapy has been successfully translated into clinical cancer treatment. so, investigators intend to review and evaluate the efficacy and safety of the parp inhibitor in combination with the vegfr inhibitor for tp53 mutation in advanced refractory solid tumors patients from a real-world population.

Eligibility criteria:
inclusion criteria: 1. is equal to or greater than 18 years of age. 2. histologic or cytologic confirmation of advanced refractory solid tumors with no standard treatment options, including some patients with advanced disease in reduced general condition (eastern cooperative oncology group (ecog) 3 and 4). 3. patients with measurable or evaluable disease per response evaluation criteria in solid tumors (recist) version 1.1. 4. patients must be able to provide blood samples or tissue samples for ngs (next generation sequencing) testing for understanding the tp53 gene status. the amount of blood and tissue samples should be able to meet the requirements of dna extraction and quality control. 5. adequate baseline organ system function. 6. patients could receive treatment program from mtb (molecular tumor board). 7. no prior treatment with parp combined with vegfr inhibitions. 8. ability to understand and the willingness to provide a written informed consent document. exclusion criteria: 1. women who are pregnant or breastfeeding. 2. prior anti-cancer therapy or radiation therapy within 2 weeks prior to enrolment. palliative radiotherapy to metastatic lesion(s) permitted providing that it has been completed at least 2 days prior to enrolment and no significant toxicity are expected. 3. clinically significant (active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months prior to study enrollment; unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring medication. 4. active infection requiring systemic therapy. 5. patients unable to swallow orally administered medication. 6. prior treatment with parp or vegfr inhibitions. 7. according to the investigator'judgment, there are serious, uncontrollable risks to patients'safety, or associated diseases (such as severe diabetes, thyroid disease, infection, spinal cord compression, superior vena cava syndrome, neurological or psychiatric disorders and so on) that affect the patients completion of the study.

Keywords: tp53 parp vegfr solid tumor
biomarker analysis of tislelizumab combined with chemotherapy for perioperative treatment of g/gej adenocarcinoma

Conditions: Locally Advanced Gastric Adenocarcinoma; PD-1

Summary: g/gej adenocarcinoma is one of the most common malignant tumors in china, ranking the fifth highest incidence and third highest mortality worldwide. currently, surgical resection is the preferred treatment for g/gej adenocarcinoma, while the 5-year survival rate of patients is lower than 25%. compared with surgical resection, immunotherapy is proved to be able to effectively prolong the survival time of patients. on one hand, with the continuous promotion of immunotherapy drugs, the exploration of neoadjuvant application of immunotherapy in g/gej adenocarcinoma has become a hotspot in recent years. it's also on their way that clinical trials of programmed death receptor-1 (pd-1), programmed death ligand-1 (pd-l1) and other immune checkpoints are carried out. on the other hand, the research found that although the curative effect of immune therapy seems better, the present g/gej adenocarcinoma immunotherapy marker researches mainly focused on the late stage of the cancer, with few studies of immune markers of neoadjuvant therapy for g/gej adenocarcinoma. additionally, it's not quite feasible for single biomarkers to predict the immune treatment effect precisely. therefore, combined with clinicopathology and therapeutic effects, this study is aimed to construct the efficacy prediction model of anti-pd-1 antibody together with chemotherapy for g/gej adenocarcinoma, by detecting rna expression. furthermore, this study will perform drug sensitivity test and bio-molecular test on patient derived organoid model to validate the biomarkers found from biological specimens.


Eligibility criteria:
inclusion criteria: 1. aged 18-80 (including 18 and 80); 2. g/gej adenocarcinoma confirmed by basic ultrasound gastroscopy, enhanced ct (pet/ct), mri or diagnostic laparoscopy; 3. biopsy histologically confirmed adenocarcinoma 4. as assessed by the investigator, patients who are qualified for receiving pd-1 mab combined with chemotherapy neoadjuvant therapy; 5. patients who volunteer to participate in this study and sign the informed consent, with good compliance and cooperation in the acquisition of biological specimens. exclusion criteria: 1. patients whose biological specimens do not meet the detection standards; 2. in the judgment of the investigator, the patients with factors that might have caused the study to be terminated.
effect of chronic mechanical neck pain on isokinetic characteristics of rotator cuff muscles in adults

Conditions: Chronic Mechanical Neck Pain

Summary: statement of the problem:would chronic mechanical neck pain affect isokinetic characteristics of rotator cuff muscles in adults? it was assumed that there would be no significant effect of chronic mechanical neck pain on isokinetic characteristics of rotator cuff muscles in adults.

sixty-six participants of both sexes between (18 and 29 years old) were enrolled in this study. thirty-three participants with chronic mechanical neck pain(cmnp) , thirty-three participants without cmnp. they were recruited from out-patient clinics of faculty of physical therapy, cairo university. instrumentation :neck pain intensity was determined by visual analogue scale , neck pain intensity was determined by neck disability index , isokinetic characteristics of rotator cuff muscles was determined by biodex isokinetic dynamometer .

Eligibility criteria:
inclusion criteria: subjects were included according to the following criteria: * thirty-three participants with chronic mechanical neck pain(cmnp) and thirty-three healthy participants would be assigned into two groups; healthy control group (a) and cmnp group (b). * right and left- handed subjects. * both sexes between 18-29 years old * (0-4 mm) no pain, (5-44 mm) mild pain, (45-74 mm) moderate pain, (75-100 mm) severe neck pain on visual analogue scale . * chronic neck pain \> 12 weeks . * they did not take any painkillers for the last 48 hours before assessment. exclusion criteria: subjects were excluded if they have any of the following: * shoulder-related pain. * the existence of any anomalies in the neck and shoulder areas. * a history of trauma or severe illnesses such as diabetes, cancer, fibromyalgia, or any kind of tumor. * disc herniation; history of identifiable structural injury. * past incidents of whiplash injury. * prior surgery; fractures. * pregnancy. * any prior rehabilitative therapy received during the last three months.

Keywords: isokinetic mechanical neck pain neuromuscular rotator cuff strength
effect of fatigue on regional anaesthesia task

Conditions: Fatigue; Anesthesia

Summary: the adverse effects of sleep related fatigue are significant, impacting on doctors' health, wellbeing, performance and ultimately their safety and that of their patients'. trainees are at an increased risk of fatigue because they routinely, and are increasingly, working long hours, and exposed to excessive and high intensity workloads. with increasing numbers of patient consultations, there is a higher risk of making poorer quality clinical decisions (i.e. decision fatigue). the excessive workloads experienced by doctors can cause fatigue through the requirement for sustained attention over long periods of time, particularly when performing complex and mentally demanding tasks. our main objective is to study the difference between the fatigued and non-fatigued state of anaesthetists and on their ability to perform an ultrasound-guided peripheral nerve blockade task. we hypothesise that fatigue will result in a clinically significant reduction in the objective structured assessment scores of anaesthetists who are performing an ultrasound-guided peripheral nerve blockade task compared to their scores when they are non-fatigued.


Eligibility criteria:
inclusion criteria: 1. anaesthetists of st3 grade and above with previous experience of performing an ultrasound guided peripheral nerve block. exclusion criteria: 1. previous experience of gaze control training or eye-tracking software applied to medical interventions. 2. no previous experience of performing an ultrasound guided peripheral nerve block.

Keywords: regional anaesthesia patient safety nerve blockade ultrasound guided needling
effectiveness of a psychoeducational group intervention in patients with depression and physical comorbidity

Conditions: Depressive Disorder

Summary: the primary aim is to evaluate the effectiveness of an intervention based on a psychoeducational program carried out by primary care nurses, to improve the rate of remission and response of depression in patients with physical chronic illness (diabetes, copd, asthma and / or ischemic heart disease). secondarily, to assess the cost-effectiveness of the intervention, the effectiveness to improve the control of physical pathology, the impact on quality of life and the feasibility of the intervention. methods: a multicentre, randomized clinical trial, with two groups and 1 year follow-up evaluation. economic evaluation study. we will study 504 patients (252 in each group), over 50 years assigned to 25 primary care teams (pc) from catalonia (urban, semi-urban and rural) with major depression and with at least one of the diseases: diabetes mellitus type 2, chronic obstructive pulmonary disease, asthma, and / or ischemic heart disease. they will be distributed randomly into two groups. the intervention group will participate in psychoeducational groups: 12 weekly 90-minute sessions led by two nurses from pc, consisting of health education on chronic physical illness and depressive symptoms. main measurements: clinical remission of depression and / or response to intervention (beck depression inventory: bdi-ii). secondary measures: improvement in control of chronic disease (blood test and physical parameters), drug compliance (test morinsky-green and number of packaging), quality of life (eq-5d), medical service utilization (appointments and hospital admissions due to complications) and feasibility of the intervention (satisfaction and compliance). evaluations will be masked and conducted at 0, 3 and 12 months. at 6 months, patients will receive a call from nurses.


Eligibility criteria:
inclusion criteria: * presence of at least one of the following diseases: type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma, and / or ischemic heart disease. * meet major depression criteria at the time of the study: score above 13 on the bdi-ii scale. * possibility of follow-up of one year by the same primary care team. * at least read and write spanish or catalan. exclusion criteria: * diagnosis of dementia or moderate or high cognitive impairment (5 or more errors according to the pfeiffer scale). * major depression with psychotic symptoms or with other serious psychiatric comorbidities. * moderate or high risk of suicide (6 or more points on the mini suicide scale). * dependency disorders due to alcohol or other drug abuse. * advanced stage physical disease. * inability to travel to the center. * be receiving some psychological therapy by the center of mental health (csm) of reference
a 12-week open-label study to investigate the efficacy and safety of brepocitinib in adults with skin-predominant dermatomyositis

Conditions: Dermatomyositis; Dermatomyositis, Adult Type

Summary: this is a prospective, 12-week, open-label, single-arm study. the study population comprises individuals with refractory skin disease characteristic of dermatomyositis with no to minimal muscle involvement. after an up to 8-week screening period, eligible participants will receive brepocitinib 30 mg orally (po) qd for 12 weeks.


Eligibility criteria:
inclusion criteria: * a diagnosis of dermatomyositis according to 2017 eular/acr classification criteria for idiopathic inflammatory myopathies * active cutaneous manifestations of dermatomyositis * adult subjects (18-75 years old) * weight \> 40 kg to \< 130 kg, and with a body mass index (bmi) \< 40 kg/m2. exclusion criteria: * dermatomyositis with end-stage organ involvement * dermatomyositis with irreversible muscle involvement history of: * any lymphoproliferative disorder * active malignancy; * history of cancer within 5 years prior to randomization (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.) cancer-associated dermatomyositis * overlap myositis/connective tissue disease (except for overlap with sjögren's syndrome) * participants at a risk of thrombosis or cardiovascular disease * participants with a high risk for herpes zoster reactivation * participants with active or recent infections

Keywords: skin-predominant dermatomyositis dermatomyositis
cytogenetic study of ocular melanoma

Conditions: Choroidal Melanoma

Summary: patients who are diagnosed with choroidal melanoma and undergo i-125 plaque or enucleation surgery consent to participate in the study. a tumor sample taken during surgery is studied in the lab for genetic features. these features and features of subjects' clinical course are recorded. analysis of the data may identify genetic features that are indicative of prognostic factors including risk of metastasis.

the jules stein eye institute ocular melanoma research group is conducting cytogenetic studies of choroidal melanoma to improve the screening of biopsy samples of choroidal melanoma through cytogenetic analysis. our goal is to identify molecular probes that specifically target regions of chromosomes that undergo changes characteristic of metastatic choroidal melanoma.

Eligibility criteria:
inclusion criteria: 1. patient with diagnosis of ocular melanoma 2. patient with local treatment plan for ocular melanoma- plaque brachytherapy or enucleation 3. patient 18 years of age or older 4. archival enucleation specimens with diagnosis of ocular melanoma exclusion criteria: 1. patient who refuses local melanoma treatment 2. patient who refuses to participate in this study

Keywords: choroidal melanoma choroidal malignant melanoma ocular melanoma uveal melanoma
sensitivity of the step test to detect improvement in dyspnea following bronchodilation in patients with chronic obstructive pulmonary disease

Conditions: Moderate Chronic Obstructive Pulmonary Disease; Severe Chronic Obstructive Pulmonary Disease; Dyspnea

Summary: during the previous phases of the project (phase i and ii), two new field tests have been designed and validated for an integration in a primary care setting in chronic obstructive pulmonary disease (copd). these new field tests are 3-min paced-walk test (3mpwt) and 3-min paced step test (3mpst). if the validity and sensitivity of the tm3 could be highlighted, particularly by the reduction of dyspnea level following bronchodilatation, phase ii highlight that the 3mpst does not allow to detect this decrease of dyspnea after bronchodilatation. the use of too high step rates could explain these results through a hypothesis relative to neuromechanical coupling of dyspnea. the main objective of this trial is to follow the investigations on the sensitivity of 3mpst to detect the effects of pharmacological intervention on the exertional dyspnea in copd patient. the hypothesis of this work is that the use of lower step rates cadences could allow to detect an improvement of exertional dyspnea following treatment-induced bronchodilatation, contrary to higher step rates.

for this project, 40 patients with copd will be recruited in 2 centres (in the institute of cardiology and pneumology of quebec and in the chest institute of montreal). for each patient, three visits will be performed. during the first visit, baseline pulmonary function and maximal exercise capacity will be evaluated and the patients will be familiarized with step test proceedings. between the different visits, a 3-7 days period will be respected. during the second and the third visits, 4 step tests will be performed at 4 different rates, following one of the two conditions (placebo or bronchodilatation). this project will propose two randomization levels. the first randomization will be relative to the choice of the condition used during the second visit (placebo ou bronchodilatation) and the second one for the rates order (14, 16, 20, 24 steps/min). during each performed exercise, cardiorespiratory and pulmonary parameters will be measured using a portable system.

Eligibility criteria:
inclusion criteria: * age higher than 50 years old * smoking history ≥ 10 packs/year * post-bronchodilator fev1 between 30 and 80% of the predicted value and fev1/fvc lesser than 70% as assessed in previous pulmonary function test (corresponding to gold stages ii and iii) exclusion criteria: * respiratory exacerbation within the preceding 6 weeks * asthmatic condition * significant o2 desaturation (sao2 \< 85%) at rest or during exercise * presence of another pathology that could influence exercise tolerance or may prevent the realization of the step test * subject having a pacemaker

Keywords: chronic obstructive pulmonary disease lung function exertional dyspnea exercise capacity pulmonary function pleural pressures