Kornimate/medical-research-clean huggingface dataset:
study on the impact of a modified mediterranean diet, in patients with colorectal cancer undergoing active medical oncology treatment

Conditions: Undefined

Summary: the study plans to evaluate the impact of the modified mediterranean diet on the biodiversity of the intestinal microbiota (the set of physiological bacteria present at the intestinal level) in patients suffering from metastatic colorectal cancer undergoing chemotherapy treatment +/- biological agent, comparing the microbiota with that of patients following a western or standard diet. specifically, as well demonstrated in clinical studies, there are populations of bacteria that play a role in protecting the intestinal barrier and whose proliferation could be promoted by the modified mediterranean diet. the study also intends to evaluate the influence of the microbiome on the clinical progress of the disease in terms of side effects and quality of life.

the study will be divided into: * screening visit (v0) and baseline visit (v1): during a control visit, the patient will be asked to participate in the study. after signing the written informed consent for participation in the mic-1 study, the patient will be screened for his nutritional status. during the visit, a folder will be used to assess nutritional status. routine blood tests will be carried out, a serum sample will be taken to measure nutritional markers and lifestyle will be assessed. furthermore, the detection of anthropometric measurements (weight, height, bmi), bioimpedance analysis, estimation of calorie-protein needs and malnutrition universal screening tool (must) nutritional screening is envisaged. once the study inclusion criteria are met, the patient will return for a visit and randomization into the study arms will take place. arm a will then be given the modified mediterranean diet (dmm), while arm b will continue to follow its usual diet. the patient will deliver the fecal sample. subsequent patient visits will take place every 15 or 21 days depending on the ongoing therapy. * visit v2: this visit will be carried out approximately 45 days after the baseline visit. the patient will deliver the stool sample. * visit v3: this visit will be carried out approximately 90 days after the baseline visit. during this visit, as per clinical practice, the radiological re-evaluation will be carried out.

Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group performance status (ecog): 0 or 1; * age ≥ 18; * diagnosis of metastatic colorectal cancer, documented histologically and radiologically according to recist 1:1 criteria; * 1st line chemotherapy treatment +/- biological agent (anti-egfr, anti-vegf); * must score 0/1; * written informed consent. exclusion criteria: * previous oncological medical therapies; * indication for parenteral and/or enteral nutrition; * must score \> 2.

Keywords: colorectal cancer metastatic modified mediterranean diet intestinal microbiota
a study to compare the lung effect of indacaterol and tiotropium in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (copd) over a 12 week period.


Eligibility criteria:
inclusion criteria: - diagnosis of copd (moderate-to-severe as classified by the global initiative for chronic obstructive lung disease (gold) guidelines, 2007) and: * a) smoking history of at least 10 pack-years * b) post-bronchodilator forced expiratory volume in 1 second (fev1) \< 80% and ≥ 30% of the predicted normal value * c) post-bronchodilator fev1/fvc (forced vital capacity) \< 70% exclusion criteria: * patients who have received systemic corticosteroids or antibiotics and/or was hospitalized for a copd exacerbation in the 6 weeks prior to screening * patients who have had a respiratory tract infection within 6 weeks prior to screening * patients with concomitant pulmonary disease * patients with a history of asthma * patients with diabetes type i or uncontrolled diabetes type ii * any patient with lung cancer or a history of lung cancer * patients with a history of certain cardiovascular comorbid conditions other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: copd indacaterol beta 2 agonist tiotropium
study of acalabrutinib in chinese adult subjects with relapsed or refractory mantle cell lymphoma, chronic lymphocytic leukemia or other b-cell malignancies

Conditions: Phase I: Relapsed or Refractory B-cell Malignancies; Phase II Cohort A: Relapsed or Refractory Mantle Cell Lymphoma; Phase II Cohort B: Relapsed or Refractory Chronic Lymphocytic Leukemia

Summary: this is an open-label, two-part study to assess the safety, tolerability, pharmacokinetics and clinical efficacy of acalabrutinib in chinese adult subjects with r/r mcl, cll and other b-cell malignancies. the study is divided into 2 parts: phase 1 portion and phase 2 portion.


Eligibility criteria:
inclusion criteria 1. capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. 2. chinese subjects at least 18 years of age at the time of study entry. 3. eastern cooperative oncology group (ecog) performance status of ≤2 4. adequate hematological and organ function. 5. presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy. 6. pathologically confirmed mcl, with documentation of chromosome translocation t(11;14) (q13;q32) and/or overexpression of cyclin d1 in association with other relevant markers (eg, cd5, cd19, cd20, pax5). disease had relapsed after or been refractory to previous treatment. 7. diagnosis of cll that meets published diagnostic criteria. must have received ≥ 1 prior systemic therapies for cll. 8. active disease per iwcll 2018 criteria that requires treatment. (cll only) 9. other relapsed/refractory b-cell malignancies without stand of care (phase 1 only). exclusion criteria 1. prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject had been disease free for ≥2 years or which would not have limited survival to \<2 years. 2. significant cardiovascular disease. 3. known central nervous system involvement of lymphoma/leukemia or leptomeningeal disease. 4. known history of hiv, serologic status reflecting active hepatitis b or c infection. 5. major surgery within 4 weeks before first dose of study drugs. 6. uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura. 7. required or received anticoagulation with warfarin or equivalent vitamin k antagonist (eg, phenprocoumon). 8. prior exposure to a bcr or bcl-2 inhibitor. 9. use of a strong inhibitor or inducer of cyp3a. 10. breastfeeding or pregnant.
evaluating the interest of interleukine-2 for patients with active warm hemolytic anemia resistant to conventional treatment

Conditions: Autoimmune Hemolytic Anemia

Summary: the investigators have demonstrated that the mean percentage of circulating cd8+ regulatory t (cd8 tregs) cells is significantly higher in patients with warm hemolytic anemia (wahai) in remission than in controls and is correlated to hemoglobin levels. in vitro, low dose of interleukine-2 (il2) induce the expansion of cd8 tregs. the objective is to demonstrate that, over a 9 week treatment period; low doses of il2 can induce the expansion of cd8tregs in patients with active wahai.

waiha is a b-cell-mediated autoimmune disease in which red blood cells are targeted by autoantibodies, which leads to marked decrease in their lifespan. the investigators demonstrated two years ago in a multivariate retrospective study that the cd3+cd8+ hla-dr+ t-cell population was associated to a better outcome. the investigators observed that the proportion of circulating cd3+cd8+cd25highfoxp3+ t cells was significantly higher in patients with waiha in remission than in controls and correlated to hemoglobin levels. extensive phenotyping and functional analysis revealed that those cells were bona fide tregs acting in an il10-dependent manner. finally, culture of pbmc from normal donors or active waihai patients with low dose of il2 promoted the expansion of functional cd3+cd8+cd25+foxp3+. those observations constituted the rationale to propose low dose of il2 to treat patients with active waiha with the objective of demonstrating that this treatment is able to induce the expansion of cd8tregs, over a 9 week treatment period. four courses of il2 (aldesleukin \[proleukin, novartis\]) will be administered subcutaneously for 5 days. the first course will be limited to a dose of 1.5 million iu per day and followed by a 9 day wash-out. the other courses of 3 million iu per day will be initiated after a 16 day wash-out. patients will be evaluated on day 1 and day 5 of each treatment course, before the first and last administration of interleukin-2 and will also be evaluated at 6 months.

Eligibility criteria:
inclusion criteria: * adults (18 years old) * wahai defined by the presence of hemolysis and positive coombs test (igg +/-c3) * absence of infection or other hematologic disease * wahai not responding to conventional steroids despite a dose over 10 mg * no treatment with rituximab for a minimum of 6 months * signed informed consent form exclusion criteria: * less than 18 years old * cold ahai * il2 allergy * chemiotherapy or immunosuppressive treatment * treatment with rituximab for less than 6 months * neoplasia or hematologic malignancy * aplastic anemia * neutropenia ≤ 1000 mm3 * infection * hepatitis b or c * wahai associated with systemic lupus erythematosus depending on acr criteria * cardiac insufficiency * hypertension * pulmonary insufficiency * liver cirrhosis * thrombopenia below 50000/mm3 * drug addiction, alcohol abuse * psychiatric disorder * absence of signed informed consent

Keywords: interleukine 2 warm autoimmune hemolytic anemia cd8 regulatory t cells
the effect of bronchiectasis on the exacerbation and mortality in copd

Conditions: Bronchiectasis; Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) is a chronic inflammatory disease of the airways and lungs that develops against harmful particles or gases with exacerbations. coexistence of bronchiectasis with copd may lead to worsening of the functional parameters as well as alteration of the microbiological pattern in exacerbations and may negatively affect the exacerbation result parameters.

chronic obstructive pulmonary disease (copd) is a chronic inflammatory disease of the airways and lungs that develops against harmful particles or gases with exacerbations. copd exacerbations are characterized by worsening of dyspnea, coughing and expectoration. exacerbations requiring hospitalization are the main cause of morbidity and mortality in copd. bronchiectasis is the irreversible extension of the bronchi. usually follows with chronic sputum cough, airway obstruction and recurrent infection episodes. the association of bronchiectasis and copd has long been known and its incidence is in the range of 30-50%. coexistence of bronchiectasis with copd may lead to worsening of the functional parameters as well as alteration of the microbiological pattern in exacerbations and may negatively affect the exacerbation result parameters.

Eligibility criteria:
inclusion criteria: * patients who underwent thoracic tomography in the last year according to index exacerbation date were included in the study exclusion criteria: * cases that mimic copd exacerbation (pneumonia, pulmonary thromboembolism, pulmonary congestion, pneumothorax, pleural effusion, lung malignancy, asthma, asthma-copd overlap syndrome) and patients admitted to the intensive care unit were excluded from the study.

Keywords: bronchiectasis chronic obstructive pulmonary disease exacerbation computed tomography
the characteristics of different personal lancets on blood volume and perceived pain in patients with diabetes mellitus

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: a randomized single-blind study with the use of different lancing devices equipped with personal lancets to determine and to compare the amount of capillary blood volume and perceived pain after a single lancing of the fingertip.


Eligibility criteria:
inclusion criteria: * willing to sign the informed consent. * must currently be diagnosed with either type i or type ii diabetes mellitus. * otherwise in good physical and mental health. * must currently be performing self-monitoring of blood glucose (self reported). * must be between 18-75 years of age (inclusive). * ability to read and follow study instructions. exclusion criteria: * pregnancy (self reported). * severe poor blood circulation in the fingers. * any skin condition on his or her fingers that prevents blood sampling. * history of a bleeding disorder. * neuropathy or other condition affecting sensation in the hands. * self-reported blood borne infection (e.g., hiv, hepatitis b or c, syphilis, malaria, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, t lymphotropic virus type 1, creutzfeldt-jakob disease). * currently participating in another study. * history of drug or alcohol abuse within the 12 months prior to screening or evidence of such abuse. * donation or loss of 400 ml or more of blood within 4 weeks prior to the start of the study. * any prescription or otc medication within two days of starting the study which might affect pain perception (for example, ibuprofen or paracetamol). * alcohol 48 hours before study start.

Keywords: lancing device lancet fingerprick capillary blood self-monitoring of blood glucose
fingolimod for type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of this study is to explore the efficacy and safety of fingoland in the treatment of type 2 diabetes. a total of 40 patients were randomly divided into two groups. one group was treated with fingolimod, another group was given guideline based treatment. the changes of islet function in patients with glycosylated hemoglobin, insulin and c-peptide were observed .


Eligibility criteria:
inclusion criteria: 1. age: 18-70 years old; 2. clinically diagnosed type 2 diabetes. 3. glycosylated hemoglobin: 6.5% - 9.5%; 4. no drug treatment or only one oral hypoglycemic drug within 6 months; 5. fasting blood glucose: \< 13.9mmol/l for those without medication, or \< 13.3mmol/l for those with medication; 6. if the antidiabetic drugs are taken, the dosage and the drug must be stable in the past 3 months. 7. body mass index (bmi) ≤ 45 kg / m2; 8. sign informed consent exclusion criteria: 1. patients with type 1 diabetes; 2. diabetic complications (ketoacidosis, hypertonic state, lactic acidosis). 3. allergic to the study drug; 4. abnormal liver and kidney function (transaminase greater than 2.5 times the upper limit of normal value; creatinine greater than 133umol / l); 5. complicated with other serious organ diseases; 6. recent disease history (within the past 6 months): myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or class iii / iv heart failure; 7. presence or history of mobitz type ii second or third degree av block or sick sinus syndrome, unless the patient has a pacemaker; 8. baseline qt interval extension (male \> 450ms or female \> 460ms); 9. treatment with class ia or class iii antiarrhythmic drugs; 10. patients with systemic infection (including but not limited to bacteria, fungi, viruses, etc.); 11. participating in other clinical trials within 3 months; 12. other circumstances that the investigator considers unsuitable for participating in this clinical study.
cytokines and acute phase reactants as markers of pulmonary tuberculosis treatment

Conditions: Pulmonary Tuberculosis

Summary: tuberculosis is a highly prevalent chronic infectious disease caused by mycobacterium tuberculosis. cytokines are important biological mediators that regulate immune and inflammatory responses against the bacilli, witch include the acute phase response. besides this, it becomes essential to determine markers of healing lesions, once this is currently carried out based on the clinical, radiological, and negative bacterioscopy.

tuberculosis is a highly prevalent chronic infectious disease caused by mycobacterium tuberculosis. cytokines are important biological mediators that regulate immune and inflammatory responses against the bacilli, witch include the acute phase response. besides this, it becomes essential to determine markers of healing lesions, once this is currently carried out based on the clinical, radiological, and negative bacterioscopy. the propose of this work was to evaluate the production of ifn- γ in cell supernatants of peripheral blood mononuclear cells (pbmc) culture, tnf-α, il-10 and tgf-b in cell supernatants of monocytes (mo) culture and biochemical (total proteins, albumin, globulin, α-1-acid glycoprotein and c-reactive protein) and hematological (vhs) serum parameters before and after 3 and 6 months of therapy

Eligibility criteria:
inclusion criteria: * diagnosis of mycobacterium tuberculosis infection exclusion criteria: * all other granulomatous or neoplastic diseases

Keywords: pulmonary tuberculosis mycobacterium tuberculosis cytokines acute phase response treatment
diffusion mri in cervical spondylotic myelopathy

Conditions: Cervical Spondylotic Myelopathy

Summary: diffusion mri in evaluates and predicts prognosis in csm

cervical spondylotic myelopathy (csm) is a spinal dysfunction disease common in the elderly population caused by cervical spine degeneration, spinal canal stenosis, and spinal cord compression. it may result in reduced quality of life or even disability. with the increased life expectancy of today's population, the incidence of csm is increasing. surgery is recommended to reduce compression of the spinal cord. however, due to individual differences and variations in spinal cord injury severity, the prognosis after surgery is often unpredictable. therefore, proper evaluation of spinal cord function and prognosis prediction are important considerations for the clinical decision of whether to operate and selection of appropriate operation time. to achieve this goal, medical images are used to correctly evaluate the damage and recovery potential of neurons. magnetic resonance imaging (mri) provides spinal cord macrostructure details and can detect spinal cord damage. clinically, conventional mri is often used to confirm a csm diagnosis and predict prognosis. however, mri assessments, including increased signal intensity (isi) and t1 hypo-intensity, might not be consistent with clinical manifestations or prognostic expectations. diffusion mri (dmri) enables early diagnoses and prognostic predictions due to its microstructure assessment advantages. the diffusion of water molecules is restricted due to structural barriers, such as axon membranes and myelin sheaths. using the microscopic movement of water molecules, dmri can detect microstructures indirectly using a model with specific underlying probability distribution function of diffusion. three models are widely applied clinically: diffusion tensor imaging (dti), diffusional kurtosis imaging (dki), and neurite orientation dispersion and density imaging (noddi). dti assumes the diffusion distribution function to be gaussian, dki assumes it to be non-gaussian, and noddi assumes it to be multi-compartmental (intracellular pool, extracellular pool, and free water). previous studies suggested the potential application value of dti and dki in patients with csm; however, these models had limited specificity and were not sufficient to diagnose csm in a clinical setting. compared with dti and dki, noddi has been shown to characterize spinal cord microstructure better.

Eligibility criteria:
inclusion criteria: * ages ranged 30-75 * compliance to mri scan * no mri contraindication * (patients) clinical diagnosis of csm and surgery in our hospital * (healthy controls) no spinal cord dysfunction exclusion criteria: * prior head or neck surgery or accompanying diseases with neurologic deficits and/or symptoms including multiple sclerosis, spinal cord injury, motor neuron disease, or spinal cord tumour * images with motion artifact
the effect of pregabalin and dexamethasone on acute and chronic pain after lumbar spinal surgery

Conditions: Pain

Summary: multimodal analgesia may be important for optimal postoperative pain treatment and facilitation of early mobilization and recovery. this study investigated the analgesic effect of pregabalin and dexamethasone in patients undergoing lumbar spinal surgery.


Eligibility criteria:
inclusion criteria: * patients scheduled for lumbar spinal surgery, aged 20 to 70 years, with a body mass index (bmi) from 18 to 32 and an american society of anesthesiologists (asa)physical status classification of i-ii were eligible for the study. exclusion criteria: * allergy to any drugs in the study * alcohol and/or drug abuse * treatment with antacids or antidepressants * a history of diabetes or epilepsy * a daily intake of analgesics or an intake of any analgesic within 24 h before surgery * treatment with systemic glucocorticoids within 4 weeks before surgery * known impaired hepatic and renal function.

Keywords: patients undergoing lumbar spinal surgery
neuroinflammatory and neurocognitive effects of spinal vs. inhalational anesthesia for elective surgery in infants

Conditions: Inguinal Hernia

Summary: significant concern regarding the safety of general anesthesia in children has arisen due to myriad animal studies suggesting neurotoxicity of commonly used anesthetic agents. inflammation of the central nervous system after anesthesia may have a significant role in the pathogenesis of anesthetic-induced neural injury. to evaluate this hypothesis, the investigators propose to randomize healthy infants undergoing elective surgery to one of two anesthetics: 1) spinal anesthesia only; or 2) general inhalational anesthesia with isoflurane, laryngeal mask airway (lma) or endotracheal tube (ett), and single-shot caudal block. primary endpoint will be serum inflammatory biomarkers and transcriptome analysis and secondary endpoint will be neurocognitive outcome at 6 months and 1 year.


Eligibility criteria:
inclusion criteria: 1. otherwise healthy child aged 0-less than 13 months undergoing elective (non-emergent) general, urologic, orthopedic, and plastic surgery 2. parent/guardian must provide written informed consent in accordance with human investigation committee guidelines 3. participants must be american society of anesthesiologist (asa) physical status ≤ 2 exclusion criteria: 1. any active bacterial or viral infection within the last 14 days 2. treatment in the last 48 hours with non-steroidal anti-inflammatory (nsaid) or corticosteroid medications, or any other drug known to suppress or induce inflammation 3. anticoagulant administration in the last 48 hours 4. patients that have an american society of anesthesiologists physical status \>2 5. infants born more than 4 weeks premature

Keywords: circumcision