Kornimate/medical-research-clean huggingface dataset:
activity & safety study of lenalidomide & rituximab as non-chemotherapy based therapy on chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: the rationale for combining lenalidomide with rituximab derives from preclinical observations suggesting that lenalidomide may enhance the adcc (antigen-dependent cellular cytotoxicity) triggered by monoclonal antibodies such as rituximab. lenalidomide augments nk cytotoxicity by increasing cd56dimcd3 subset, in addition to inducing il-2 in t cells. these results provide the cellular and molecular basis for the use of lenalidomide as an adjuvant in immunotherapeutic strategies of monoclonal antibodies (mab)-based therapies. the combination lenalidomide-rituximab was tested in lymphoma cell lines but not specifically on cll cell lines. however the observed synergism was attributed to nk cells expansion, thus lending support to the notion that this synergism may operate in other b-cell lymphoproliferative malignancies. the objective was to develop a non-cytotoxic and effective treatment for cll that would fulfill an unmet medical need, as a significant proportion of cll patients are elderly and frail. these patients experience an excess in chemotherapy induced toxicity, often preventing the completion of the planned treatment.


Eligibility criteria:
inclusion criteria: * recurrent and refractory cll patients that have received at least one previous treatment with purine analogs. * adequate liver function and renal function. * ecog performance status ≤ 2. * signed informed consent * male and female patients who are fertile agree to use an effective barrier method of birth control to avoid pregnancy. exclusion criteria: * positive serological markers for hepatitis b with the exception of hbsac in previously vaccinated patients * pregnant patients * hiv infection * concurrent chemotherapy or immunotherapy * other malignancy within the last 2 years, except for localized cutaneous carcinoma * neurological impairment precluding understanding of protocol and the entailed visits and procedures. * patients with renal insufficiency that requires dialysis.

Keywords: recurrent and refractory chronic lymphocytic leukemia
dexmedetomidine after cesarean for the treatment of nausea and shivering

Conditions: Shivering; Nausea and Vomiting, Postoperative

Summary: this is a randomized double blinded trial to determine if a small dose of dexmedetomidine can prevent and relieve nausea and shivering, two of the more common complaints after cesarean delivery.

this study is a randomized, placebo controlled, double blind evaluation of the use of a single dose of dexmedetomidine for the prevention of shivering and nausea after cesarean delivery. it is hypothesized that patients who receive dexmedetomidine (as compared to placebo) will have a reduced severity of postoperative shivering and nausea. study subjects will be have a scheduled cesarean section. they will receive written, informed consent obtained before surgery. after enrollment, patients will receive spinal anesthesia consisting of 11.25mg bupivacaine, 25 mcg of fentanyl, and 250 mcg of morphine. all iv fluid will be warmed. after delivery of the neonate, delivery of the placenta, and assurance of adequate uterine tone, patients will be randomized in a 1:1 fashion to receive a blinded study syringe consisting of either placebo saline, or 10 mcg of dexmedetomidine. study outcomes will be measured on an 11-point likert scale assessing shivering, nausea, pain, pruritus, and sedation. assessments will be performed on admission to the recovery room, and at 30 and 60 minutes.

Eligibility criteria:
inclusion criteria: * elective cesarean delivery * ≥ 18 years of age * singleton pregnancy * term delivery (37 weeks or greater gestation) * spinal or combined spinal-epidural anesthesia is planned exclusion criteria: * non-elective cesarean delivery * receiving misoprostil or carboprost * postpartum hemorrhage greater that 1000cc * chronic opioid use * history of chronic nausea or itching in pregnancy * receiving medications for nausea * inability to provide written informed consent * receiving of any of the following medications intraoperatively: misoprostil, carboprost, medications for nausea * postpartum hemorrhage greater that 1000cc

Keywords: dexmedetomidine cesarean spinal anesthesia
study comparing lecozotan sr two 5-mg tablets vs. lecozotan sr one 10-mg tablet in healthy subjects

Conditions: Alzheimer Disease

Summary: to determine the bioequivalence between two 5-mg tablets of lecozotan and the new 10-mg tablet of lecozotan.


Eligibility criteria:
inclusion criteria: * generally healthy, man and women, aged 18 to 50 years. exclusion criteria: * history or active presence of clinically important medical disease.
yoga on dyspnea, sleep and fatıgue in chronıc respıratory dıseases

Conditions: Chronic Respiratory Disease

Summary: although there are a limited number of studies in the literature investigating the effect of yoga on dyspnea, quality of life and respiratory functions of chronic respiratory patients there is no study examining the effect of yoga on sleep and fatigue of chronic respiratory patients. therefore, this study was conducted to determine the effect of yoga on dyspnea, sleep, and fatigue applied to chronic respiratory patients.

chronic respiratory diseases (csfd) are chronic diseases of the airways and other structures of the lung. two of the most common of these diseases are asthma and chronic obstructive pulmonary disease. asthma and chronic obstructive pulmonary disease (copd); mortality, morbidity and prevalence of chronic respiratory diseases are increasingly increasing across countries. copd; it has been defined as a common, preventable and treatable disease characterized by permanent airflow restriction, which is associated with the increased chronic inflammatory response of the airways and lungs to harmful gases and particles every year, 3 million people die of copd in the world and this rate constitutes 6% of all deaths if it is asthma; it is defined as a heterogeneous disease characterized by chronic airway inflammation associated with airway hyperresponsiveness to direct or indirect stimuli. asthma is seen at a rate of 1-18% in the whole world population

Eligibility criteria:
inclusion criteria: * between the ages of 18-55 and diagnosed with asthma and copd for at least six months, * do not have any disease that causes insomnia and do not use sleeping pills * has the ability to use the internet actively, download the zoom program to the phone or computer and participate in the application. have not participated in a similar regular exercise program in the last 6 months, * do not have any respiratory system disease other than asthma and copdy, * not in exacerbation period, * do not have a physical illness or cognitive deficiency and a psychiatric disease that prevents understanding of the education given, * patients who were literate and volunteered to participate in the study were included in the study. exclusion criteria: * in the period of exacerbation have participated in a similar regular exercise program in the last 6 months, those who cannot download the zoom program and participate in the application
digestive tract cancer and cipn

Conditions: Digestive Tract Cancer; Chemotherapy-induced Peripheral Neuropathy; Remote Exercise

Summary: according to the incidence rate of cancer, the digestive tract cancer accounts for two of the top ten cancers. it also accounts for half of the top ten causes of cancer death. chemotherapy remains one of the most common forms of cancer treatment, and chemotherapy-induced peripheral neuropathy (cipn) is one of the common adverse effects of cancer treatment in cancer survivors. to date, there is no exercise guideline established for patients with cipn; therefore, cipn remains quite threatening to cancer survivors. due to limited studies on effects of exercise on improvement of cipn symptoms in patients with digestive tract cancers, this study aims to investigate the effects of exercise and different intervention delivery modes (remote home exercise and exercise under supervision) at different time points on the cipn symptoms, body inflammatory index, physical function, and quality of life of gastrointestinal cancer survivors with chemotherapy-induced peripheral neuropathy.


Eligibility criteria:
inclusion criteria: 1. age 20 and above; 2. diagnosed by a physician with gastrointestinal cancer and has undergone chemotherapy or is currently undergoing chemotherapy; 3. diagnosed by a physician with chemotherapy-induced peripheral neuropathy. exclusion criteria: 1. cognitive impairment or inability to cooperate with verbal instructions; 2. neurological, muscular, skeletal, or cardiovascular issues preventing participation in exercise training; 3. age 80 or above; 4. refusal to engage in exercise intervention or participate in data collection.
a study to evaluate safety and pharmacokinetics/pharmacodynamics of sustained release(sr) exenatide

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of sr exenatide (pt302) in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy male subjects aged 20-45 years at screening * body weight over 50 kg, inclusive, and within 20% of ideal body weight exclusion criteria: * has a present illness or medical history of hepatic, renal, respiratory, cardiovascular disease, blood tumor, mental disorder, and endocrinologic disorder, especially diabetes mellitus * has a sign or symptom or history related to an acute or chronic pancreatitis * has a known allergy or hypersensitivity to exenatide or other drugs such as aspirin, antibiotics, and so on * has ever been exposed to exenatide * shows sbp \>= 150 mmhg or \ = 100 mmhg or \<= 50 mmhg * has a presence or history of drug abuse * uses any prescription drug, herbal medicine within 2 weeks or otc drugs or vitamin within 1 week prior to study drug administration * has been participated in other clinical trial within 2 months * has experience of a blood donation during 2 months or a blood transfusion during 1 month prior to study drug administration * heavy smoker more than 10 cigarettes/day within 3 months prior to screening * continuous drinker (over 21 units/week, 1 unit = 10 g of pure alcohol) or subject who can't quit drinking nor smoking during clinical trial period * subjects not eligible at the discretion of investigators

Keywords: diabetes exenatide sr exenatide peptron
effect of amlodipine versus bisoprolol on hypertensive patients with end-stage renal disease on maintenance hemodialysis.

Conditions: Hypertension, Renal

Summary: hypertension is highly prevalent in hemodialysis (hd) patients and leads to increased morbidity and mortality due to cardiovascular disease(cvd). left ventricular hypertrophy (lvh) is both a manifestation of hypertension caused end-organ damage and an independent risk factor for cvd. evidence shows that beta-blockers, especially of low dialyzability decrease risk of cvd and mortality. calcium channel blockers (ccbs) were also shown to effectively control bp in the volume expanded state and reduce cardiovascular disease risk. asymmetric dimethyl arginine (adma) is a uremic toxin that decreases no synthesis and is correlated to lvh, carotid intimal thickness (cit), cvd, and mortality. amlodipine is shown in one study to significantly reduce adma level in hd patients. the purpose of this study is to determine the effect of calcium channel blocker amlodipine compared to beta-blocker bisoprolol on regression of lvh, reduction of adma plasma level and on bp control among hypertensive patients on hd.


Eligibility criteria:
inclusion criteria: * on maintenance hemodialysis 3 times weekly for at least 3 months. * hypertensive as determined by predialytic bp \> 140/ 90, post-dialytic \> 130/80, home-measured bp \>140/90, office based bp \>140/90 and/or on antihypertensive medication. exclusion criteria: * history of malignancy. * history of significant valvular heart disease. * chronic congestive heart failure. * history of coronary artery disease. * ongoing atrial fibrillation. * known drug abuse. * known contraindication to bisoprolol or amlodipine. * history of mi * history of stroke
study of spg302 in adults with schizophrenia

Conditions: Schizophrenia

Summary: this phase 2 study described herein will evaluate the safety, efficacy, tolerability, and pharmacodynamics of spg302 in adults with a primary diagnosis of schizophrenia.

this phase 2 study will evaluate the safety, efficacy, tolerability, and pharmacodynamics of spg302 in adults with a primary diagnosis of schizophrenia. this is a randomized, placebo-controlled study of spg302 administered once daily for six weeks. this study will entail weekly visits to the study site for screening, study procedures, and receipt of investigational medication for use at home.

Eligibility criteria:
inclusion criteria: * age 18-65 * primary diagnosis of schizophrenia * clinical laboratory values within normal range or \< 1.5 times uln * currently prescribed only one antipsychotic medication, with stable dose for at least 4 weeks * able and willing to provide written informed consent exclusion criteria: * any physical or psychological condition that prohibits study completion * known cardiac disease * active or history of malignancy in the past 5 years * history of clinically significant cns event or diagnosis in the past 5 years. * receipt of investigational products within 30 days * blood donation within 30 days

Keywords: synaptogenesis synapse dendritic spines
formulated psta injection versus pata alone in the management of macular edema secondary to non-ischemic retinal vein occlusions

Conditions: Macula Edema

Summary: the aim of this study is to compare formulated posterior subtenon triamcinolone acetonide (psta) injection versus posterior subtenon triamcinolone acetonide alone in the management of macular edema secondary to non-ischemic retinal vein occlusions, either central or branch.


Eligibility criteria:
inclusion criteria: * diminution vision due to macular edema secondary to non-ischemic retinal vein occlusions, either central or branch, as evidenced by clinical and angiographic evaluation * cmt ≥ 250 µ. * willing to participate in the study exclusion criteria: * unwilling to participate in the study. * ischemic rvo * prior laser treatment * glaucoma/ocular hypertension * cataract which lead to difficulty in the evaluation of macula * vitreous hemorrhage * macular ischemia * iris neovascularisation * patients with intravitreal injection of anti vegfs, steroid, or any intraocular surgery 3 months prior to the inclusion.
effectiveness of continuous negative external pressure in preventing upper airway impairment during routine colonoscopy

Conditions: Airway Obstruction; Apnea; Hypopnea

Summary: the primary goal of this study is to determine the effectiveness and safety of delivering continuous negative external pressure (cnep) to the upper airway as a means of preventing episodes of respiratory impairment (ri) such as hypoxemia, apnea and hypoventilation associated with the use of intravenous sedation in elective colonoscopy in adult patients.


Eligibility criteria:
inclusion criteria: * male or female subjects undergoing elective colonoscopy at the study site who have fewer than three or more than three positive responses on the stop bang questionnaire exclusion criteria: * presence of severe cardiopulmonary or neurologic disease as determined by the investigator * history of vascular fragility associated with cutaneous pressure * history of hypersensitivity to silicone * inability to properly fit cnep collar to the subject * the presence of excessive facial hair in the region where the cnep collar is positioned * known carotid vascular disease, previous major neck surgery or radiation therapy to the cervical region * presence of anatomical abnormalities in the neck or pharyngeal region (such as enlarged tonsils) * inability to provide informed consent

Keywords: colonoscopy oxygen desaturation
precision diagnostics of functional and organic intestinal pathology based on cellular and molecular profiling

Conditions: Inflammatory Bowel Diseases; Irritable Bowel Syndrome; Healthy Volunteers

Summary: differential diagnosis of functional and organic intestinal pathology is carried out in line with approved clinical guidelines and includes a significant list of interventions. however, considering the possibility of an "overlap" between functional and organic diseases, as well as the non-specificity of a number of assessment parameters, it is advisably to define new diagnostic approaches and reliable cell and molecular markers, that will update and ensure the precision diagnostics of intestinal diseases. the integrative functional, cell and molecular markers will create the basis and possibilities for the personalized selection of patient therapy. the study is intended to develop the methods of precision diagnostics based on cellular-molecular profiling with an assessment of functional parameters of the intestine in functional and organic intestinal diseases.


Eligibility criteria:
inclusion criteria: * signed informed consent * gender: male or female * age: 18-70 years old * clinically, laboratory and/or endoscopically confirmed diagnosis of functional (irritable bowel syndrome) and organic (crohn's disease, ulcerative colitis) intestinal disease * healthy volunteers exclusion criteria: * age under 18 or over 70; * acute intestinal infections; * antibiotic-associated intestinal lesions; * tuberculosis of the intestine; * systemic vasculitis; * oncological diseases; * diverticulitis; * solitary rectal ulcer; * ischemic colitis; * syndrome of bacterial overgrowth; * decompensation of chronic diseases of the cardiovascular system or acute cardiovascular diseases; * acute or exacerbation of chronic respiratory diseases, respiratory failure; * acute infectious diseases; * diabetes mellitus; * disorders of the blood coagulation system; * mental disorders * female patients who are pregnant, planning to become pregnant or lactating * participation in a clinical trial in the past 3 months and in any other incomplete clinical trials (including follow up - the period of observation after completion of the study) * any condition which, in the opinion of investigator, makes the patient unsuitable for participation in the study

Keywords: inflammatory bowel disease crohn's disease ulcerative colitis irritable bowel syndrome precision diagnostics metabolomics genomics transcriptomics immunology
efficacy of intravenous gamma globulin on guillain-barre syndrome

Conditions: Guillain-barre Syndrome

Summary: guillain-barre syndrome (gbs) is an acute immune-mediated polyneuropathy. intravenous gamma globulin is an effective therapy.although high doses of gamma globulin are clinically effective, the patient's recovery and clinical prognosis vary. the establishment of a cohort study on the therapeutic effect of gamma globulin in guillain-barre syndrome is beneficial to the diagnosis of the disease and to the understanding of the natural course of the disease and the efficacy of drug treatment.


Eligibility criteria:
inclusion criteria: 1. meet the brighton guillain-barre syndrome diagnosis criteria in 2014; 2. age ≥18; 3. patients with aidp, aman and amsan; 5. ivig was treated within 2 weeks of onset; 6. gbs disability scale\>2; 6. cooperate with patients who were followed up for 180 days and sign the informed consent; exclusion criteria: 1. age \<18; 2. pregnant or nursing women; 3. patients with chronic inflammatory demyelinating multiple peripheral neuropathy; 4. combined with other types of immune system diseases; 5. accept drugs that affect the function of the immune system within 5 or 3 months; 6. concomitant neoplastic diseases. 7. the patient or guardian refused to sign the informed consent.
pre-emptive low-dose doxycycline during anti-egfr treatment

Conditions: Colorectal Cancer; Skin Toxicities

Summary: up to 60% of patients with metastatic colorectal cancer can be treated with one of monoclonal antibodies targeted against epidermal growth factor receptor (egfr). this treatment is associated with a specific spectrum of toxicity: acne-like rash from limited up to erythema, often with severe pruritus, sometimes combined with other types of skin toxicities (hair and nail changes). previously in stepp study investigators shown that pre-emptive treatment with oral doxycycline (200 mg daily), topical steroids and sun blockers reduces the number of more severe skin side effects of panitumumab. the study is designed to described the profile of skin toxicity of egfr blocking drugs combined with low-dose doxycycline (100 mg daily) used in the pre-emptive manner.

patients with metastatic colorectal cancer treated with cetuximab or panitumumab usually develop the skin toxicity which can impair patients' quality of life as well as limit the treatment. we designed this trial to assess the effect of simplified protocol of pre-emptive treatment on the observed skin toxicities during cetuximab and panitumumab treatment of colorectal cancer. the study is a cohort observational, single center study which should result in estimation of particular types of toxicities, especially occurence of more severe (grade 2 and 3) side effects and assess the tolerance of doxycyline in the prolonged administration. the observation in the study is biweekly and is continued up to 8 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of metastatic colorectal cancer, * previously qualified to either cetuximab or panitumumab, * written consent. exclusion criteria: * previous administration of cetuximab or panitumumab, * contradictions to receive oral doxycycline.

Keywords: colorectal cancer skin rash pre-emptive treatment doxycycline anti-egfr antibody cetuximab panitumumab