Kornimate/medical-research-clean huggingface dataset:
hydralazine valproate for cervical cancer

Conditions: Metastatic Cervical Cancer

Summary: the current standard for recurrent, persistent or metastatic cervical cancer is palliative chemotherapy with cisplatin topotecan, however, the results need to be improved. epigenetic aberrations play an important role in cancer progression by silencing growth regulatory genes and there is now evidence that inhibitors of dna methylation and hdac inhibition synergize the cytotoxicity of chemotherapy. objective. to determine the superiority of epigenetic therapy with hydralazine and valproate plus standard cisplatin topotecan against placebo plus cisplatin topotecan upon progression-free survival. hypothesis. hydralazine and magnesium valproate associated to cisplatin topotecan will increase progression-free survival from 4.6 to 7.6 months as compared with the same regimen of chemotherapy plus placebo.

randomized, double-blind phase iii trial. a total of 143 patients (alpha 0.5, power 0.8)with metastatic, persistent or recurrent cervical cancer without previous systemic treatment will be randomized to cisplatin topotecan + placebo or cisplatin topotecan hydralazine valproate for 6 courses every 3 weeks. patients will receive an oral dose of hydralazine of 182mg (rapid) or 83mg (slow) according to the acetylator phenotype in a single daily dose and magnesium valproate at an oral dose of 40mg/kg t.i.d. both drugs in a slow-release formulation. experimental drugs or placebo will start from seven days before day 1 of chemotherapy until the end of the sixth course.

Eligibility criteria:
inclusion criteria: * informed consent, histological diagnosis of persistent, recurrent or metastatic cervical carcinoma; measurable disease by physical examination, ct scan, mri or pet-ct. biopsy is required for confirmation only if the lesion is unique, has less than 2cm in the longest diameter or has no clearly defined borders. * patients should have no previous systemic treatment (could have received chemotherapy as radiosensitization to the pelvis and or para-aortic field. * aged \>18 years, performance status 0-2 according to ecog classification, and adequate liver, hematological and renal function, as defined by: hemoglobin \>10 g/l, leukocytes \>4000/mm3, platelets \>100 000mm3; normal creatinine value and creatinine clearance \>60 ml/min; total bilirubin \< 1.5 upper normal limit value. exclusion criteria: * history of allergy to hydralazine or valproate; past or present condition of rheumatic disease, central nervous system disease, heart failure from aortic stenosis and postural hypotension as diagnosed by a physician; newly diagnosed hypertension patients with or without pharmacological treatment are allowed as long as their treatment do not include hydralazine. * previous use of the experimental drugs (hydralazine and magnesium valproate) as well as if patients were pregnant or breast-feeding. other exclusion criteria are uncontrolled systemic disease or infection.

Keywords: epigenetic therapy hydralazine valproate cervical cancer randomized phase iii
omega: outcome measures in eosinophilic gastrointestinal disorders across the ages

Conditions: Eosinophilic Gastrointestinal Disorders (EGIDs); Eosinophilic Esophagitis; Eosinophilic Gastritis; Eosinophilic Gastroenteritis; Eosinophilic Colitis

Summary: the purpose of this observational study is to find the best measures to define how well a person with eosinophilic disorder is doing. people with eoe, eog, eon and eoc normally undergo endoscopy and/or colonoscopy where cells are collected for microscopic analysis. treatments are then decided based on how the cells look. we are aiming to compare different tissue components such as inflammatory cell types with clinical symptoms. we want to see if scores on standard questionnaires can give us an idea how well the person is doing.

this is a longitudinal observational study in which individuals (males and females 3 years of age and greater) with eoe, eog, eon and eoc will be followed over the course of time to see if standard questionnaires can give us an idea of how well the person is doing. participants undergoing standard of care (normal, routine care) endoscopies and/or colonoscopies will have biopsies (small pieces of tissue from the gi tract normally collected during these procedures) collected and used for the research study. participants will also complete questionnaires related to their symptoms and quality of life. participants will be followed over the course of time and asked to complete the questionnaires at various time points throughout the study.

Eligibility criteria:
inclusion criteria: * males or females 3 years of age and older * mucosal eosinophilia: eoe ≥ 15 eosinophils/hpf in the distal or proximal esophagus eog ≥ 30 eosinophils/hpf in 5 hpf\&#39;s in the body and/or antrum eon ≥ 53 eosinophils/hpf in the duodenum and/or ≥ 56 eosinophils/hpf in the jejunum and/or ileum eoc ≥ 84 eosinophils/hpf from the transverse or descending colon and/or ≥ 32 eosinophils/hpf from the rectosigmoid colon or a biopsy from any colonic location with ≥ 100 eosinophils/hpf - presence of symptoms is required for patients who are newly diagnosed but not required for patients who were previously diagnosed. exclusion criteria: * history of intestinal surgery other than g tube placement * enrolled in a blinded investigational study at the time of the first study visit * have esophageal stricture (\&lt;3mm) * have other identifiable causes for eosinophilia (except inflammatory bowel disease): infections, gastrointestinal (gi) cancer, other gi inflammatory disease (e.g., ulcerative colitis or crohn\&#39;s disease)
role of rem sleep alterations in post operative delirium after cardiac surgery

Conditions: Delirium Symptoms

Summary: acute confusional states known as delirium frequently occur in intensive care units (icu), mostly after cardiac surgery, leading to serious consequences. sleep deprivation has been described in icu patients and is considered as a risk factor for delirium but its role is still unknown. it is therefore essential to identify whether sleep deprivation and more specifically rem sleep alterations could facilitate occurence of delirium in icu.


Eligibility criteria:
inclusion criteria: * patients who had a cardiac surgery with extracorporeal circulation. * patients who were extubated at day 0. * patients without any operation or anesthetic complication. * patients who speak french. * patients without tnc at day 1. * patients who had completed the questionnaires before operation. exclusion criteria: * age \< 18 years old. * delirium at day 1. * central nervous system pathology or psychiatric pathology known and treated. * concomitant use of neuropsychiatric treatment before surgery that interferes with sleep. * clinical condition alteration before polysomnography exam. * continue sedation required before day 3 polysomnography exam. * agitation or clinical alteration that did not allow day 3 polysomnography exam.

Keywords: patient
effectivity of mesenchymal stem cell on vertebral bone defect due to mycobaterium tuberculosis infection

Conditions: Spinal Tuberculosis; Mesenchymal Stem Cell

Summary: this study evaluates the effectiveness of locally implantation of mesenchymal stem cell on vertebral bone defects due to infection of mycobacterium tuberculosis. there are controlled participants who receives placebo and patients who receives implantation of msc

mesenchymal stem cell are implanted in spinal tuberculosis patient. msc has inflammatory effect and the ability to form into new bone. in spinal tuberculosis, the spread of bacteria is commonly hematogenous, where the focus of infection is at the anterior part of the vertebrae near the subchondral bone. the infection process continues, where the necrotic casseous fragments formed into local abcess that may spread to the sorrounding area. patient with spinal tuberculosis who receives anti tb drug, is planned to undergo debridement, spinal stabilization. after thorough debridement, patient who fall into control group receives normal saline injection, patients who fall into treatment group will receive mesenchymal stem cell.

Eligibility criteria:
inclusion criteria: * clinicoradiologically diagnoses spinal tuberculosis * receives anti tb drugs * minimun destruction 1/3 vertebral body exclusion criteria: * patient under 15 years old * reject to be included in the study

Keywords: mycobacterium tuberculosis
comparison study of daily ultrafiltration and twice-weekly hemodialysis

Conditions: End-stage Renal Disease

Summary: in this study, the researchers want to find out how patients who have ultrafiltration (removal of excess fluid) 6 times a week and twice-weekly dialysis (removal of excess fluid and waste products) do in terms of their blood pressure and weight. the researchers believe that maintaining patients at their estimated target weight throughout the week using daily ultrafiltration will reduce their blood pressure to levels shown in other similar studies. such a reduction in blood pressure may reduce the incidence of cerebral vascular disease, peripheral vascular disease, coronary artery disease, and congestive heart failure. the researchers also believe that patients' quality of life will improve while they are undergoing daily ultrafiltration. studies show that more frequent dialysis treatments result in fewer symptoms for patients. the patients feel better and avoid the weight gains and symptoms that patients have on three times a week dialysis. in addition, their blood lab results are better controlled, requiring less medication.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years and less than or equal to 80 years * stable three treatments per week dialysis schedule for at least three months prior to beginning the study * residual renal clearance \<1.5ml/min per 35l of urea volume * pre-dialysis serum sodium levels of greater than 136 meq/l exclusion criteria: * non-compliance with hemodialysis treatments--defined as missing more than 1 treatment over the 3 month period prior to the study * unable to verbally communicate in english or spanish * current requirement for hemodialysis more than three times per week due to medical comorbidity (including fourth session for ultrafiltration) * currently on daily or nocturnal hemodialysis, or less than 3 months since discontinued such treatment * expected geographic unavailability at dialysis center during any phase of the trial * less than 3 months since the patient returned after acute rejection resulting in allograft failure * currently in acute care or chronic care hospital * pregnancy * current involvement in any non-observational trial * unable or unwilling to follow the study protocol for any reason (including mental incompetence) * unable or unwilling to provide informed consent or sign irb-approved consent form * pace maker, implantable pump, artificial joint * amputation of a limb

Keywords: end-stage renal disease chronic kidney disease hemodialysis
efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing multiple sclerosis

Conditions: Relapsing Multiple Sclerosis

Summary: to compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis

this was a randomized, double-blind, double-dummy, active comparator-controlled, parallel-group, multi-center study with variable treatment duration in approximately 900 patients with relapsing multiple sclorosis (rms). the maximal treatment duration in the study for an individual patient was 2.5 years. eligible patients were randomized to receive either experimental ofatumumab subcutaneous (s.c.) injections every 4 weeks or active comparator teriflunomide orally once daily. the dose regimen for ofatumumab for this study was a loading dose regimen of 20 mg at day 1, day 7 and day 14, followed by a maintenance dose regimen of 20 mg administered every 4 weeks starting at week 4. in order to blind for the different formulations, double-dummy masking was used i.e. all patients will take injections (containing either active ofatumumab or placebo) and oral capsules (containing either active teriflunomide or placebo).

Eligibility criteria:
inclusion criteria: * 18 to 55 years of age * diagnosis of multiple sclerosis (ms) * relapsing ms: relapsing-remitting ms (rrms) or secondary progressive ms (spms) * at least 1 relapse during the previous 1 year or 2 relapses during the previous 2 years or a positive gadolinium-enhancing mri scan in previous year * expanded disability status scale (edss) score of 0 to 5.5 exclusion criteria: * primary progressive ms * disease duration of more than 10 years in patients with an edss score of 2 or less * patients with an active chronic disease of the immune system other than ms * patients at risk of developing or having reactivation of hepatitis * patients with active systemic infections or with neurological findings consistent with pml

Keywords: relapsing multiple sclerosis ofatumumab adult omb157 multiple sclerosis t1 lesions t2 lesions relapse gd-enhancing mri mcdonald criteria rrms spms
validation of a new device to measure neuromuscular disease progression

Conditions: Amyotrophic Lateral Sclerosis & Other Neuromuscular Disorders

Summary: there is a great need for the development of sensitive outcomes that allow experimental drugs to be tested in human subjects more efficiently. if we could more precisely measure whether an experimental drug slows the progression of als or other neuromuscular diseases, this would allow more drugs to be tested quicker and at less expense. we have developed a new device that accurately measures isometric strength called: accurate test of limb isometric strength (atlis). this device was designed to be portable, quick, and easy to use, while generating accurate and reliable, interval level data. this study will enable us to test the reliability and validity of atlis.


Eligibility criteria:
inclusion criteria: * all subjects must be at least 18 years old and able to provide informed consent * all subjects have no health conditions that limit their ability to safely exert maximal force using the muscles in their arms and legs. * subjects with a diagnosis of laboratory supported probable, probable or definite als according to the world federation of neurology el escorial, as determined by their referring neurologist at mgh. * all subjects must be able to speak and understand english. exclusion criteria: * presence of significant arthritis, orthopedic conditions, or cardio-pulmonary conditions or other medical conditions that may limit the ability to maximally exert force safely.

Keywords: strength testing disease progression als healthy adults
psychosocial treatment for acute low back pain

Conditions: Acute Low Back Pain

Summary: acute low back pain (severe pain that comes on suddenly and lasts a relatively short time) is very common in the united states, and accounts for substantial illness, functional limitations, pain, and health care costs. this study looks at whether a program designed to improve self-efficacy (a person's belief in his or her ability to reach a goal, such as managing one's own disease) and social support improves the health status of people with acute low back pain.

acute low back pain (albp) is very prevalent in the united states, accounting for substantial morbidity, functional limitations, pain, and health care costs. psychosocial interventions that target improved symptom control and patient functioning have the potential to improve the outcomes of patients with albp. this study evaluates a psychosocial intervention designed to enhance self-efficacy and social support for patients with albp. in this randomized, controlled trial, we will randomize eligible patients with albp to receive the intervention or usual care. the intervention program consists of: (1) patient education regarding albp; (2) explanations and rationales, in layperson's terms, of diagnostic and treatment options for albp; (3) discussions regarding the management of negative affect (i.e., depression, anger, fear, hostility, anxiety); (4) methods to involve social support systems; and (5) strategies to involve the primary care physician to reinforce patients' behaviors and progress. we will follow patients for 12 months and assess outcomes at 3 and 12 months. primary outcomes are health-related quality of life (i.e., functional status, role function, back pain symptoms) and patient satisfaction with care. secondary outcomes include health care use, direct health care costs, self-efficacy, and social support. we will also estimate the cost-effectiveness of the intervention. we will conduct this investigation among socioeconomically vulnerable patients with albp, a group that shoulders a disproportionate burden of disability and morbidity from musculoskeletal conditions and comorbid medical conditions.

Eligibility criteria:
inclusion criteria: * acute low back pain exclusion criteria: * chronic back pain (including surgery) * disability claim for back pain * nursing home resident * severe impairment in hearing, vision, or speech * unable to speak english * severe comorbidity * unable to contact by phone * excluded by primary care physician

Keywords: oa patient education acute low back pain (albp) social support systems
impact of ibd activity on frailty in patients over 60 years

Conditions: IBD

Summary: the goal of this observational, multicenter, descriptive, prospective, and longitudinal study is to evaluate the impact of ibd activity on frailty in a prospective and longitudinal cohort of patients with ibd, and also to assess the impact of frailty on the risk of hospitalization and mortality in patients with ibd aged ≥60 years. the main questions it aims to answer are: 1. can frailty and consequently the risk of complications (adverse events, hospitalization, and mortality) be reversed through proactive treatment in frail patients with active inflammatory bowel disease? 2. which frailty index is the most effective for predicting the risk of complications in patients with active inflammatory bowel disease? at inclusion, clinical frailty indices will be calculated. additionally, clinical variables related to ibd and comorbidities will be recorded. during follow ups visits frailty, comorbidities, ibd activity, changes in medical treatment for ibd, adverse effects, hospitalizations, and mortality will be reassessed.


Eligibility criteria:
inclusion criteria: * patients aged ≥60 years with ibd (crohn's disease or ulcerative colitis) diagnosed according to ecco criteria and under follow-up in the ibd units of participating centers. * initiation of medical treatment (oral mesalazine, topical or systemic corticosteroids, immunosuppressants, and/or biologics) due to clinical activity based on pro2 scales (uc: pro \>4; cd: pro2 \>14) and/or biological activity (fecal calprotectin ≥500 mg/kg, c-reactive protein ≥10 mg/l). * signed informed consent for inclusion. exclusion criteria: * lack or withdrawal of informed consent. * unclassified/indeterminate colitis. * change in medical treatment solely due to adverse events. * initiation of treatment only with salicylates and/or topical steroids for disease activity. * treatment intensification to manage disease activity. * patients with an ostomy. * comorbidities with a life expectancy of less than one year.
a study to test how effective and safe different doses of bi 655130 are in patients with a moderate to severe form of the skin disease palmoplantar pustulosis

Conditions: Palmoplantar Pustulosis (PPP)

Summary: the primary objective is to provide dose-ranging data for 4 dose regimens of bi 655130 compared to placebo on the primary endpoint of percentage change from baseline in ppp asi at week 16. the target dose(s) will be estimated from the model by incorporating information on the minimum clinically relevant effect and accounting for safety. supportive dose-ranging assessments will also be done on pre-specified secondary endpoints.


Eligibility criteria:
inclusion criteria: * 18 to 75 years of legal age (according to local legislation) at screening. * diagnosis of palmoplantar pustulosis defined as presence of primary, persistent (\>3 months duration), sterile, macroscopically visible pustules on the palms and/or soles, without or with plaque psoriasis elsewhere on the body. * ppp pga of at least moderate severity (≥3) at screening and baseline. * a minimum ppp asi score of 12 at screening and baseline. * male or female patients. women of childbearing potential (wocbp) must be ready and able to use highly effective methods of birth control per ich m3 (r2). * signed and dated written informed consent in accordance with ich gcp and local legislation prior to admission to the trial. * further criteria apply. exclusion criteria: * women who are pregnant, nursing, or who plan to become pregnant while in the trial. * severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof. * presence or known history of anti-tnf-induced ppp-like disease. * patient with a transplanted organ (with exception of a corneal transplant \>12 weeks prior to screening) or who have ever received stem cell therapy (e.g., prochymal). * known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly. * further criteria apply.
pharmacokinetics, pharmacodynamics, safety and tolerability of bi 10773 in type ii diabetes patients with different degrees of renal impairment

Conditions: Diabetes Mellitus, Type 2

Summary: assessment of the effect of normal and impaired kidney function on the pharmacokinetics, pharmacodynamics and safety of bi 10773


Eligibility criteria:
inclusion criteria: 1. male and female subjects with type 2 diabetes 2. renally impaired male or female subjects 3. age 18 - 75 years 4. bmi 18 - 34 kg/m2, at least 45 kg for females (body mass index) 5. signed and dated written informed consent exclusion criteria: 1. significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders as judged by the investigator. 2. relevant gastrointestinal tract surgery 3. diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or relevant neurological disorders 4. history of relevant orthostatic hypotension, fainting spells or blackouts; systolic blood pressure \ 160 mm hg, diastolic blood pressure \ 100 mm hg, pulse rate \ 100 1/min 5. chronic or relevant acute infections 6. history of allergy/hypersensitivity (including drug allergies) that are deemed relevant to the trial as judged by the investigator 7. use within 10 days prior to administration or during the trial of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation. co medication known to inhibit or induce p-glycoprotein or cyp3a is not allowed. inhibitors of p-glycoprotein or cyp3a (cytochrom p3a) are e.g. * protease inhibitors, (e.g. ritonavir, lopinavir nelfinavir) * azole antimycotics, (itraconazole, ketoconazole, miconazole) * macrolid antibiotics, (clarithromycin, erythromycin) * amiodarone, cimetidine, diltiazem, fluvoxamine, mibefradil, nefazodone, verapamil, tacrolimus, quinidine, reserpine, cyclosporine a inducers of p-gp or cyp3a are e.g. carbamazepine, phenobarbital, phenytoin, rifabutin, ri-fampin, st. john's wort, troglitazone. in dubious cases, a case by case decision will be made after consultation with the sponsor.