Kornimate/medical-research-clean huggingface dataset:
sars-cov-2 specific immune response after covid-19 vaccination in cancer patients

Conditions: COVID-19; Cancer

Summary: our study highlights a low degree of neutralization-afforded protection mounted by coronavac in cancer patients when compared with healthy volunteers, especially patients who received chemotherapy. further booster doses, beyond the conventional two-dose regimen might be needed for recipients of coronavac to maintain a long-term anamnestic response.

a total of 311 participants, including 107 patients with solid tumor and 204 healthy volunteers who received 2 doses of coronavac were recruited from national cancer institute of thailand between 2020-2021. blood samples were collected after second dose of coronavac for 15 days and the neutralizing antibody (nab) titers were detected using live-virus neutralization.sars-cov-2 antibody positivity was detected in 77 (72%) patients and 199 (97.5%) healthy volunteers. antibody positivity rate was lowest (67.2%) in patients who received chemotherapy, followed by patients with post-treatment (74.2%) and patients who planned to start treatment (91.7%). our study highlights a low degree of neutralization-afforded protection mounted by coronavac in cancer patients when compared with healthy volunteers, especially patients who received chemotherapy. further booster doses, heterologous or otherwise, beyond the conventional two-dose regimen might be needed for recipients of coronavac to maintain a long-term anamnestic response.

Eligibility criteria:
inclusion criteria: * male or female age at least 18 years * patients with a diagnosis of solid tumors * ability to understand the patient information and study consent. signed and dated written informed consent must be available before performing any study-related procedure * willing and able to comply with the study procedures. * willing to receive a coronavac vaccine (sinovac). exclusion criteria: * patients who cannot provide consent

Keywords: covid-19 cancer immune response
physical activity and testicular cancer

Conditions: Testicular Cancer

Summary: the purpose of this study is to determine the feasibility and effect of a program including information, counseling and an individualized physical activity program on physical and psychological health during and after chemotherapy in patients with testicular cancer. it is hypothesized that the patients are able to complete the intervention with individual adjustments.


Eligibility criteria:
inclusion criteria: * seminoma/non-seminoma * stage ii-iv * 3-4 bep(bleomycin,etoposide and cisplatin)or 4 ep(etoposide and cisplatin) * \> 18 years * capable of reading and writing norwegian exclusion criteria: * conditions of a severity that contraindicate exercise without adjusted actions * mentally incompetent conditions * conditions of a severity that complicates the ability to participate in a supervised training program

Keywords: physical activity testicular cancer chemotherapy feasibility
oleclumab (medi9447) epidermal growth factor receptor mutant (egfrm) non-small cell lung cancer (nsclc) novel combination study

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the objective of this study is to investigate the safety, tolerability, and antitumor activity of novel combination therapies administered in participants with advanced egfrm nsclc.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 2. eastern cooperative oncology group (ecog) performance status of 0 or 1 3. weight ≥ 35 kg 4. diagnosed with histologically or cytologically confirmed locally advanced/metastatic nsclc with egfrm * for arm a (oleclumab + osimertinib arms): must have received 1 prior line of therapy with an egfr tyrosine kinase inhibitor (tki) and confirmed t790m negative * for arm b (oleclumab + azd4635 arms): must have received at least 2 but not more than 4 prior lines of therapy. exclusion criteria: 1. receipt of an egfr tki within 14 days of the first dose of study treatment 2. receipt of any conventional or investigational anticancer therapy not otherwise specified within 21 days of the planned first dose 3. prior receipt of any investigational immunotherapy. participants may have received agents that have local health authority approval for the disease indication 4. concurrent enrollment in another therapeutic clinical study. enrollment in observational studies will be allowed. 5. participants with a history of venous thrombosis within the past 3 months 6. participants with prior history of myocardial infarction, transient ischemic attack, or stroke in the last 6 months 7. active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment 8. other invasive malignancy within 2 years 9. untreated central nervous system (cns) metastatic disease, leptomeningeal disease, or cord compression 10. current or prior use of immunosuppressive medication within 14 days prior to the first dose additional exclusion criteria for arm a 1. concurrent treatment (or inability to stop therapy) with medications or herbal supplements known to be potent inducers of cytochrome p (cyp) 3a4 2. participants has a history of interstitial lung disease (ild), drug-induced ild, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ild 3. participants requires continuous supplemental oxygen for any reason additional exclusion criteria for arm b 1. herbal preparations/medications are not allowed throughout the study 2. history of seizures excluding those that occurred due to previously untreated cns metastasis

Keywords: egfr mutated cd73 a2ar oleclumab medi9447 azd4635 osimertinib nsclc immunotherapy
treatment of hepatitis c by using direct-acting antiviral

Conditions: Hepatitis C

Summary: patients with hepatitis c showed increased level of oxidative stress. increased level of serum lipid peroxidation leads to the production of toxic mediators as malondialdehyde (mda) which lead to disease progression. chronic stress shunt tryptophan which is essential amino acid toward kynurenic pathway leading to lower level of serotonin and melatonin level. currently, direct-acting antivirals (daas) show well-established efficacy against hepatitis c virus (hcv).


Eligibility criteria:
inclusion criteria: * chronic hepatitis c patients had no other cause of liver disease exclusion criteria: * patients with hepatitis b virus (hbv). * patients with acute hepatitis. * patients with renal insufficiency. * patients with hepatocellular carcinoma (hcc) or other types of malignancy. * patients on current use of melatonin. * patients using of any of medications that have interaction with melatonin. * patients work in night shifts. * patients are consuming a lot of caffeine or heavy smokers.
effectiveness of breathing exercises as therapeutic play on respiratory status among children with lower respiratory tract disorders

Conditions: Respiratory Status

Summary: the study evaluates the effectiveness of breathing exercises as therapeutic play on respiratory status among children with lower respiratory tract disorders. patient were allocated into two groups- experimental group and comparison group. experimental group received breathing exercises as therapeutic play after administration of nebulization therapy and comparison group received no breathing exercises.

the subjects were selected by purposive sampling technique and allocated into 2 groups i.e experimental and comparison group. the total sample size for the study was 60 children i.e 30 in experiment group and 30 in comparison group. experimental group- pre-assessment of respiratory status among children was assessed. then after 5 minutes of administration of nebulization, breathing exercises as therapeutic play (balloon inflation, candle blowing, blow air into water with a straw was administered for 15 minutes once in a day for 3 days consecutively and then post-assessment was taken daily 5 minutes after the administration of breathing exercises as therapeutic play. comparison group- pre-assessment of respiratory status among children was assessed. then only nebulization therapy was administered and then post-assessment was taken daily after 25 minutes of administered.

Eligibility criteria:
inclusion criteria: * 5-18 years of age * prescribed with nebulization therapy * able to understand hindi. * available during the period of data collection and willing to participate in study. exclusion criteria: * having upper respiratory tract infection * on ventilator support. * coming to hospital for opd visits.

Keywords: breathing exercises respiratory status nebulization therapy lower respiratory tract disorders
a study to evaluate the efficacy and safety of galantamine in patients with mild cognitive impairment

Conditions: Dementia; Alzheimer Disease

Summary: the purpose of this study is to evaluate the efficacy and safety of galantamine treatment in patients with mild cognitive impairment.

this is an international, multicenter, double-blind, randomized, placebo-controlled trial. following a 4 week screening period, patients with mild cognitive impairment (mci), who are clinically at risk for development of alzheimer's disease, will be randomized to treatment with either placebo or galantamine for 24 months with either placebo or a flexible dose of galantamine. efficacy will be evaluated by measures of memory and cognition (alzheimer's disease assessment scale of cognition for mci \[adas-cog/mci\] and the clinical dementia rating sum of the boxes \[cdr-sb\]), global severity of dementia (clinical dementia rating \[cdr\]), functionality (alzheimer's disease cooperative study - activities of daily living adapted to mci \[adcs-adl/mci\]), and changes on serial magnetic resonance imaging (mri). safety will be assessed using adverse event reports, vital signs, laboratory parameters, physical examination and electrocardiograms. the primary study hypothesis is that galantamine will improve memory deficits associated with mild cognitive impairment and therefore improve or stabilize the patient's cognitive abilities. a second study hypothesis is that treatment with galantamine slows or delays conversion of mild cognitive impairment to the dementia often associated with probable alzheimer's disease in these patients. the third study hypothesis is that the treatment will be well tolerated by the patients. galantamine hydrobromide immediate-release tablets (4, 8, and 12 milligrams (mg)) taken by mouth 2 times daily: 4 weeks at 8mg/day, 4 weeks at 16mg/day, increased to 24mg/day for the remainder of the 24-month trial. dose may be reduced at investigator's discretion after 12 weeks.

Eligibility criteria:
inclusion criteria: * clinical decline of cognitive ability consistent with mild cognitive impairment * delayed recall score less than or equal to 10 on new york university paragraph recall test * sufficient visual, hearing and communication capabilities and willingness to complete serial standard tests of cognitive function * have a consistent informant to accompany them on scheduled visits * be able to read, write and fully understand the language of the cognitive scales used in the study exclusion criteria: * contraindications for magnetic resonance imaging, for example, presence of pacemaker or presence of metal in high risk areas * neurodegenerative disorders such as parkinson's disease * cognitive impairment resulting from acute cerebral trauma, hypoxic cerebral damage, vitamin deficiency states, infections such as meningitis or aids, or primary of metastatic cerebral neoplasia * significant endocrine or metabolic disease * mental retardation * women who are pregnant, nursing, or lacking adequate contraception

Keywords: dementia alzheimer disease mild cognitive impairment galantamine hydrobromide memory disorder
study comparing two administration pathways for adenosine during microvascular function assessment

Conditions: Microvascular Coronary Artery Disease

Summary: the aim of this study is to investigate the agreement and reproducibility between intravenous and intracoronary adenosine administration during invasive assessment of microvascular function. goals of this study are: 1. agreement and reproducibility between intravenous and intracoronary adenosine administration in the imr (index of microvascular resistance) value. 2. agreement and reproducibility of ffr(fractional flow reserve), cfr (coronary flow reserve), mrr (microvascular resistance reserve), rrr (resistive reserve ratio) and reproducibility of each of these as compared with cfrabs (absolute coronary flow). 3. time required for imr measurements

the study is a single-center randomized, cross-over controlled, open label trial to investigate the reproducibility and agreement between intravenous and intracoronary adenosine administration during invasive assessment of microvascular function. the primary analysis will be on the per-protocol population (i.e. including all patients who are not protocol violators). primary endpoint: 1. agreement and reproducibility between intravenous and intracoronary adenosine administration in the imr value. secondary endpoints: 1. agreement and reproducibility of ffr, cfr, mrr, rrr and reproducibility of each of these as compared with cfrabs. 2. time required for imr measurements 3. presence and severity of angina, assessed by saq(seattle angina questionnaire)-7 4. assessment of safety: presence and severity of av( atrioventricular) block, dyspnea, flush

Eligibility criteria:
inclusion criteria: * chronic coronary syndrome (including patients with anginal equivalents). * indication to cardiac catheterization; * indication to the assessment of microvascular function (note: patients will be asked for participation and consented prior to the first measurement of microvascular function, which will be conducted as per clinical indication) * willingness to participate and ability to understand, read and sign the informed consent * age\>18 years exclusion criteria: * age \<18 years * bronchial asthma, copd (chronic obstructive pulmonary disease) * secondary or tertiary atrioventricular block without prior pacemaker implantation * previous cabg (coronary artery bypass graft) with patent grafts to the left anterior descending coronary * epicardial coronary disease (ffr \<0.80 with evidence of a focal stenosis) in the left anterior descending territory * inability to provide informed consent

Keywords: adenosine coronary microvascular assessment microvascular disease
running versus interrupted deep plane sutures in massive weight loss patients

Conditions: Weight Loss

Summary: the goal of this study is to assess whether running deep wound stiches will be superior to deep interrupted stiches in body contouring surgeries in massive weight loss patients. this is a split-wound study, thereby providing an internal control within each wound. each side of the wound will be randomized to receive one of the two suturing techniques. patients and raters will be blinded to the suture technique used in both wound-halfs.


Eligibility criteria:
inclusion criteria: * age 18 and over * brachioplasty, tighplasty, abdominoplasty, circumferential dermolipectomy in a massive weight loss patient * the subjects are in good health * the subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator. exclusion criteria: * under 18 years of age * subjects who are unable to understand the protocol or to give informed consent * subjects with mental illness
third optimizing anti-platelet therapy in diabetes mellitus (optimus-3)

Conditions: Diabetes Mellitus; Coronary Artery Disease

Summary: this trial is designed as a phase 2 randomized, double-blind double dummy, active comparator controlled, two-period two-arm crossover study to enroll 40 patients across multiple centers. the study will compare platelet function following a prasugrel loading dose and 1 week of prasugrel maintenance therapy with high-dose clopidogrel loading dose and 1 week of high-dose clopidogrel maintenance therapy in patients with drug treated type 2 diabetes mellitus who have coronary artery disease. various assays of platelet function will be used in this study. platelet function will be studied using the following assays: accumetrics verifynowtm p2y12, light transmittance aggregometry (lta), vasodilator-associated stimulated phosphoprotein (vasp), and thromboelastography (teg)-platelet mapping.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus and on oral or parenteral hypoglycemic therapy for at least 1 month. * history of coronary artery disease with or without other types of vascular disease (such as peripheral vascular disease). * taking aspirin 75-325 mg/day for at least 1 week prior to randomization. * between the ages of 18-74 years old. * if a woman of child bearing age, must not be pregnant and must agree to use reliable method of birth control during the duration of the study. exclusion criteria: * thienopyridine therapy within 30 days or have a defined need for thienopyridine treatment. * coronary artery bypass graft (cabg) or percutaneous coronary intervention (pci) with no stent placed within 30 days. * planned coronary revascularization * hemoglobin a1c (hba1c) \> or equal to 10 mg/dl within the last 3 months. * received fibrolytic therapy \<24 hours prior to randomization. * received non-fibrin-specific fibrinolytic therapy \<48 hours prior to randomization. * at risk of bleeding. * history of ischemic stroke, transient ischemic attack (tia), intercranial neoplasm, arteriovenous malformation, or aneurysm. * body weight \<60 kilograms (kg). * international normalized ratio (inr) \>1.5, platelet count \<100,000/mm3, or anemia (hemoglobin \<10 gm/dl) within 1 week of study entry. * are receiving or will receive oral anticoagulation or antiplatelet treatment therapy. * are being treated with daily non-steroidal anti-inflammatory drugs (nsaids). * are pregnant, breast-feeding or plan to become pregnant.
impact of a gluten-free diet on quality of life in patients with axial spondyloarthritis.

Conditions: Ankylosing Spondyloarthritis

Summary: subclinical intestinal inflammation and gut dysbiosis have been reported in patients with spondyloarthritis (spa). in common practice, rheumatologists are increasingly confronted with patients with inflammatory rheumatism who are on gluten-free diets (gfds), despite the lack of reliable data from controlled studies. this study aims to determine the impact of a gfd on the quality of life of patients with axial spa.

the glutenspa study is a 24-week, randomized, double-blinded, placebo-controlled, multicenter trial. patients with axial spa (n=200) will follow a 16-week gfd and be randomly assigned (1:1) to an experimental or control arm. in the experimental arm with receive at least 6 gluten-free breads per day + 200 g of gluten-free penne pasta per week + 6 rice flavor capsules per day. the control arm will receive at least 6 gluten-containing breads per day + 200 g of gluten-containing penne pasta per week + 6 vital gluten-containing capsules per day. at baseline, the dietician will explain to the patients how to properly follow a gfd during a face-to-face interview. the patient's compliance to the gfd will be evaluated by the dietician at s2, s16, an s24 using an online 3-day alimentary questionnaire. the bread and penne pasta were chosen for their visual resemblance and similar taste to maximize the blindness of the study. in order to reach the daily amount of gluten in a standard diet (estimated in france between 10 and 15 g/d) in the control arm, each day patients will have to ingest six capsules of vital gluten wheat made for the study. vital gluten flour is an over-the-counter food supplement used to enrich a protein diet or as a base for making products, such as seitan. capsules will be made using commercially available vital gluten and contain 0.35 g of gluten per capsule. the total amount of gluten in the control arm will be approximately 10.5 g/day. after the 16-week gfd, patients will be offered to follow or not follow the gfd according to their own decision for an 8-week open-labelled follow-up period. the study duration for each patient is 24 weeks. the patient recruitment is expected to last 2 years

Eligibility criteria:
inclusion criteria: * diagnosis of axial spa defined by asas criteria * rheumatologist not wish to change the treatment within 4 months of inclusion, * stable treatment (nsaid and/or dmard) for at least 3 months but no corticosteroid infiltration in the month prior to inclusion, * able to follow a gfd and to provide written informed consent and submit to the requirements of the study exclusion criteria: * any diet at the time of inclusion or within 3 months prior to inclusion; * have a history of celiac disease; * received antibiotic treatment within 3 months of inclusion or are taking a probiotic; * are pregnant, breastfeeding, * not covered by social security; * minors or adults under the protection of the law or under the protection of justice.

Keywords: spondyloarthritis ankylosing spondylitis gluten-free diet gut microbiota
treatment with rosuvastatin versus switching pi (protease inhibitor) in patients hiv with high cholesterol levels

Conditions: HIV; Hypercholesterolaemia

Summary: to compare the effect of rosuvastatin to protease inhibitor switching on fasting total cholesterol over 12 weeks.

to compare the effects of rosuvastatin to protease inhibitor switching on: * total cholesterol through week 12 * safety parameters (hiv viral load, clinical adverse events, serious adverse events, laboratory adverse events, modifications to antiretroviral therapy) * quality of life (sf-12) * fasting ldl cholesterol (estimated with friedewald equation unless triglycerides \>400mg/dl, in which case ldl-c would be measured directly), hdl cholesterol, total : hdl cholesterol ratio, ldl particles sizes, triglycerides * fasting glucose and insulin * framingham cardiovascular risk score * d:a:d 5-year estimated risk calculator

Eligibility criteria:
inclusion criteria: * hiv-positive status * adults (≥18 years of age) * stable and well-tolerated combination art including a ritonavir-boosted protease inhibitor for the previous 6 months * hiv rna \<50 copies/ml for at least the preceding 3 months * fasting total cholesterol ≥5.5 mmol/l (\>213 mg/dl) * framingham risk score ≥8% at 10 years or diabetes mellitus or a family history of premature coronary artery disease in a first-degree relative * provision of written, informed consent exclusion criteria: * any statin in the previous 12 weeks * previous statin-induced myopathy or hepatitis * history of coronary artery disease, stroke or any other indication for the use of statin therapy (hyperlipidaemia: genetic, secondary or idiopathic) * concurrent use of: 1. oral corticosteroids use other than for replacement therapy (i.e. prednisolone 5-7.5 mg, hydrocortisone 20-30 mg, cortisone acetate 25-37.5 mg daily) 2. other immunosuppressive or immunomodulating drugs * contraindication to rosuvastatin therapy: 1. liver transaminases \>5 times the upper normal limit 2. creatinine clearance \<30 ml/min 3. known myopathy 4. current fibrate therapy 5. known resistance to one or more "backbone" art drugs * no potent switch art drug available to replace the current ritonavir-boosted protease inhibitor * known intolerance to rosuvastatin or the proposed switch art drug * women attempting or likely to become pregnant, or who are pregnant or breast-feeding * a patient with a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study * unable to complete study procedures

Keywords: hypercholesterolaemia hiv rosuvastatin protease inhibitor switching