Kornimate/medical-research-clean huggingface dataset:
using intradialytic blood pressure slopes to guide ultrafiltration

Conditions: ESRD; Extracellular Fluid Alteration; Hypertension

Summary: this study is an open label randomized clinical trial that comparing intradialytic blood pressure slope-based ultrafiltration prescriptions to standard care in the chronic fluid management of maintenance hemodialysis patients. it also includes a cross sectional component evaluating the associations between intradialytic blood pressure slopes ascertained over 2 week periods with measurements of extracellular water/body weight obtained with multifrequency bioimpedance spectroscopy.


Eligibility criteria:
inclusion criteria: * age greater than 18 years * end stage renal disease on maintenance hemodialysis * hypertension defined as systolic blood pressure \> 140 mmhg pre-dialysis or \>130 mmhg post dialysis exclusion criteria: * hemodialysis vintage \< 1 month * pregnancy * nadir systolic blood pressure \< 95 mmhg * pre or post dialysis systolic blood pressure \> 180 mmhg * decrease in systolic blood pressure \>60 mmhg from pre to post dialysis * ultrafiltration rate \>13 ml/kg/hr * peridialytic midodrine use * intradialytic clonidine use * documented antihypertensive medication non-adherence bioimpedance will not be peformed on patients with * amputated arms or legs * cardiac defibrillator or pacemaker * presence of metal prostheses
national database of bone metastases

Conditions: Bone Metastases

Summary: bdmo is an italian multicentre, observational, prospective study that collects data from all patients with bone metastases referred to each participating centre, using an on-line software 'tailor-made' for data collection.


Eligibility criteria:
inclusion criteria: * radiological and/or histological diagnosis of bone metastasis from histologically established solid tumor * males or females aged \>= 18 years * informed consent exclusion criteria: * not applicable
the inhibitory effect of metformin on gluconeogenesis in relation to polymorphisms in organic cation transporter 1

Conditions: Pharmacogenetics of Metformin

Summary: the aim of the study is to evaluate the pharmacodynamic impact of metformin in healthy caucasian volunteers with and without single polymorphisms m420del or r61c in oct1, thus the study hypothesis is that metformin only affect the hepatic gluconeogenesis in healthy volunteers with functional oct1-transporters.


Eligibility criteria:
inclusion criteria: * healthy volunteers * written consent * genotyped in oct1 for (m420del and r61c) exclusion criteria: * daily medication * alcohol abuse * pregnancy * breastfeeding

Keywords: metformin hypoglycemic agents diabetes mellitus, type 2 gluconeogenesis pharmacodynamics pharmacogenetics
heart rate variability (hrv) among children with brain damage

Conditions: Brain Injury; Cerebral Palsy

Summary: to investigate the function of the autonomic nervous system in children with with post traumatic brain injury and children with cerebral palsy through an analysis of heart rate variability (hrv) occurring with walking performance.

40 children with brain damage (20 with post tbi and 20 with cp)and 40 typically developed children will be participate in this study. ecg signals during rest and walking (for 6 minute and during step climbing) will be recorded.

Eligibility criteria:
inclusion criteria: * able to walk independently exclusion criteria: * can not follow simple commands
pacing for heart failure with preserved ejection fraction

Conditions: Heart Failure

Summary: the purpose of this research study is to evaluate the safety of a new pacing method (fusion pacing) for heart failure patients with an ejection fraction (ef) greater than 50% over a period of 4 months, and determine the effects on different measures of heart failure. this new pacing method may allow the heart to pump more efficiently. participation in this study will last approximately 8 months.

patients with an ef greater than 50% and a regional mechanical delay of \>= 65ms (an indication of mechanical dyssynchrony) will receive an implantable cardioverter defibrillator (icd) with a special pacing feature. when the feature is active, the device wil pace the left ventricle to target improved pump efficiency. patients will have the feature active for 4 months and inactive for 4 months. the order will be randomized and the patient will not know whether the pacing is active or not. echocardiography, biomarkers, exercise testing, quality of life (qol) testing and device information will be used to compare the patient's status while the feature is active vs. inactive.

Eligibility criteria:
inclusion criteria: * patients with quantitative ejection fraction (ef) of greater than 50 percent * patients with active heart failure (symptomatic american heart association/american college of cardiology stage c) despite optimal medications * patients greater than 18 years of age * patients willing and able to give informed consent * patients available for appropriate follow-up times for the length of study * patients able to complete cardiopulmonary exercise (cpx) testing * patients expected lifespan is greater than 12 months beyond study enrollment * patients with a regional mechanical delay (rmd) (septal-lateral) greater than 65 milliseconds exclusion criteria: * patients who have undergone cardiac surgery 60 days prior to enrollment * patients who have had a myocardial infarction 90 days prior to enrollment * patients with hemodynamically significant uncorrected cardiac valvular disease * patients with active myocarditis and amyloidosis (if documented) * patients with a permanent pacemaker * patients with creatinine greater than 2 milligrams per milliliter or estimated glomerular filtration rate (egfr) less than 30 to 50 milliliters per hour * patients with permanent or chronic sustained atrial fibrillation (fibrillation lasting 7 days or more at a time) * patients with a pr interval greater than 250 milliseconds * patients with severe chronic obstructive pulmonary disease * patients with high risk coronary artery disease * patients who are or expect to become pregnant during this study * patients enrolled in concurrent studies which could confound the results of this study * patients with hypertrophic cardiomyopathy (obstructive or non-obstructive) * patients with infiltrative disease or restrictive cardiomyopathy * patients with indication for percutaneous coronary intervention (pci) at enrollment
peri-neural electrical dry needling migraine treatment study

Conditions: Migraine Headache

Summary: this study seeks to determine the effectiveness of a specific treatment protocol using dry needling with perineural electrical stimulation in comparison to standard treatment in physical therapy for patients with migraine headaches. this will be a randomized cross-over study in which participants will be in the first arm of the study, have a washout period, then cross over to the other arm of the study.

from current understanding of migraine pathophysiology, the investigators know that it involves excitability of the trigeminovascular system. intercranial vasculature containing nociceptor innervation consists of unmyelinated (c-fibers) and thinly myelinated (a-delta fibers ) axons which hold vasoactive neuropeptides including substance p and (cgrp) calcitonin gene related peptide. when a migraine occurs, there is a cortical spreading depolarization, which on a molecular level involves a release of atp, glutamate, potassium, hydrogen ions, glia or vascular cells, and cgrp and nitric oxide by activated perivascular nerves. these substances, including cgrp diffuse to come in contact with nociceptors causing neurogenic inflammation (vasodilation), thus propagating a headache. electrical perineural dry needling causes the release of substance-p and cgrg predominantly from non-neural structures, facilitating a negative feedback loop to neural and neuroactive components of the target tissue. this causes a lowering of the levels of cgrp which in turn decreases the inflammatory component thought to play a role in migraine headaches.

Eligibility criteria:
inclusion criteria: * men and women age 18 to 100 years old * acute or chronic manifestation of migraine headaches or prior diagnosis of migraine headache. * numeric pain rating of 3/10 (where 0= no pain and 10= worst pain) exclusion criteria: * history of epilepsy * needle-phobia * unstable psychological status * compromised immune system * metallic allergy * having not eaten within the past 3 hours * inability to lie in prone, or side-lying * pregnant or trying to become pregnant * inability to consent or understand english. * prisoners
anti-pseudomonas igy to prevent infections in cystic fibrosis

Conditions: Cystic Fibrosis; Infection; Pseudomonas Aeruginosa

Summary: hypothesis: daily gargling with specific avian antibodies against pseudomonas aeruginosa will prevent infections with this bacteria in patients with cystic fibrosis (cf).

"anti-pseudomonas igy" is prepared from eggs of hens that have been vaccinated with pseudomonas aeruginosa. the hens farm is under veterinary control according to swedish rules. the drug is prepared with a water dilution method according to gmp standards (approved by swedish mpa). patients with cf who are intermittently but not chronically infected with p. aeruginosa get a short course of antibiotics to eradicate the bacteria. thereafter they start to gargle with a solution of "anti-pseudomonas igy" every night to prevent a new infection. preliminary results have shown that it takes a significantly longer time to get a new infection and that the patients get fewer infections than control patients. in addition, results tentatively indicate that: patients have not got any new opportunistic bacteria or fungi (b. cepacia, s. maltophilia, a. xylosoxidans, atypical mycobacteria, aspergillus fumigatus); that use of antibiotics is greatly diminished; that the lung functions and nutritional conditions are maintained.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cystic fibrosis * colonized with pseudomonas aeruginosa * informed consent exclusion criteria: * egg allergy

Keywords: cystic fibrosis prevention infection pseudomonas aeruginosa gargle
use of intravenous acetaminophen in pediatrics undergoing spinal fusion surgery

Conditions: Scoliosis; Adolescence

Summary: the purpose of this study is to investigate whether perioperative intravenous acetaminophen administration reduces postoperative pain and opioid consumption in adolescents and pediatric patients undergoing spinal fusion surgery.

spinal fusion surgery to correct scoliosis causes severe postoperative pain in adolescents and pediatric patients. thus, appropriate control of postoperative pain has a significant impact on postoperative recovery, patient satisfaction and reduction of hospital stay. although pain control was achieved through only opioids, the importance of multimodal analgesia has recently been emphasized as opioid addiction and side effects increase. acetaminophen is recommended as a key factor in multimodal analgesia and previous studies performed in adult spine surgery showed that intravenous administration of acetaminophen reduced the postoperative pain and opioid consumption. in addition, acetaminophen is a drug widely recognized for safety in adolescents and pediatric patients and has a fast and predictable analgesic effect. therefore, the purpose of this study is to investigate whether perioperative intravenous acetaminophen administration reduces postoperative pain and opioid consumption in adolescents and pediatric patients undergoing spinal fusion surgery. thus the specific aim of this trial the investigators will determine is; 1. the decrease in postoperative analgesic requirement following iv acetaminophen 2. the decrease in intensity of postoperative pain following iv acetaminophen 3. the quality of recovery including self-reported recovery, physical and functional recovery and length of stay 4. the preemptive analgesic effect of iv acetaminophen

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status 1-3 * patients undergoing spinal fusion surgery exclusion criteria: * patients who refuse to participate in this study * patients unable to communicate due to mental impairment or developmental delay * patients allergic to acetaminophen or its additives or who are contraindicated in acetaminophen administration for other reasons * patients with existing liver diseases or dysfunction (i.e. active hepatitis, clinically relevant chronic liver conditions, elevated liver enzymes) * patients who are judged ineligible by the medical staff to participate in the study for other reasons

Keywords: scoliosis, acetaminophen
a trial of one-week on/one-week off temozolomide versus continuous dose-intense temozolomide in patients with glioblastoma multiforme at first relapse

Conditions: Glioblastoma

Summary: the purpose of this study is to evaluate the clinical benefit and safety of two different dose-intense temozolomide regimens（one-week on/one-week off regimen versus continuous dose-intense regimen）in patients with glioblastoma at first relapse.


Eligibility criteria:
inclusion criteria: 1. participants must have histopathologically-confirmed, supratentorial, glioblastoma. 2. participants must have received first-line treatment regimen consisting of rt plus concomitant temozolomide followed by adjuvant temozolomide. 3. participants must be first recurrence or progression of glioblastoma after first-line treatment regimen. 4. participants must have demonstration of recurrent disease on mri following prior therapy. 5. participants must have bi-dimensionally measurable disease with a minimum measurement of 1 cm in one dimension on mri performed within 14 days prior to first treatment. if receiving corticosteroids, participants must be on a stable or decreasing dose of corticosteroids for at least 5 days prior to baseline mri. 6. participants must have developed progressive disease after receiving prior therapy and must have an interval of at least 12 weeks from the completion of radiation and concomitant temozolomide therapy to study entry (unless progressive tumor growth is outside the radiation field or there is histopathological confirmation of recurrent tumor) 7. age 18-75 years old. 8. life expectancy of at least 12 weeks. 9. karnofsky performance status at least 60 10. participants must be able to adhere to the dosing and visit schedules, and agree to record medication times, concomitant medications, and adverse events (aes) accurately and consistently in a daily diary. 11. 20 paraffinsections of glioblastoma tissue must be available. 12. participants must have normal organ and marrow function as defined below: leukocytes \>4.0×10\^9/l，platelets \>100×10\^9/l，hemoglobin \> 10 g/dl，serum creatinine\< 1.5-fold upper normal range，ast and alt \<2-fold upper normal range, alkaline phosphatase \< 3-fold upper normal range. 13. female and male subjects of childbearing potential must agree to use a medically accepted method of adequate contraception. exclusion criteria: 1. treatment with any chemotherapy other than temozolomide prior to enrollment. 2. progressive or recurrent glioblastoma documented by mri earlier than 12 weeks after completion of radiotherapy. 3. history of any other cancer. 4. hiv infection. 5. women who are pregnant or breast feeding.

Keywords: glioblastoma relapse temozolomide glioblastoma at first relapse
safety study on a wood-plastic composite cast

Conditions: Distal Radius Fracture

Summary: an ecologically friendly and biodegradable wood-plastic composite-cast is studied. patients, who has sustained a distal radius fracture in need of splinting are requested to participate in the study.


Eligibility criteria:
inclusion criteria: * distal radius fracture not older than 14 days * age 17-90 years * mother tongue finnish or swedish exclusion criteria: * open fracture * other fractures or a previous fracture * a previous or simultaneous tendon-, nerve- or vascular injury to the upper extremity * a multiple injured hand * decreased co-operation of the patient * malignancy * an illness affecting the general health

Keywords: cast, radius fracture
the impact of depression and/or anxiety on pci patients

Conditions: Acute Coronary Syndrome; Depression; Anxiety

Summary: the purpose of this study is to evaluate how depression and/or anxiety could effect the prognosis of the patients post-acs after pci.

this trial is a prospective, multi-centric, real-world clinical study. about 5,000 patients with acs post-pci will be recruited according to the resource available of each participating center to represent real-world setting. patients enrolled in the project will accept two-years' follow-up and will be assessed on mortality, cardiovascular events, and severity of depressive or anxiety symptoms using self-rating scales continuously during the trial, in which their treatment for anxiety or depression will also be documented.

Eligibility criteria:
inclusion criteria 1. aged \> 18 years old 2. patients with a diagnosis of acs including acute myocardial infarction (mi) and unstable angina (ua). acute mi diagnosis must be met with at least two of these following criteria: typical chest pain, abnormal elevation of cardiac biomarkers, and electrocardiographic changes consist with mi. the diagnosis of ua includes new onset angina within 1 month, crescendo angina, resting angina, infarction angina, and variant angina. 3. good recovery from pci. 4. volunteer for the study and sign the informed consent. exclusion criteria 1. severe heart failure, defined as left ventricular ejection fraction (lvef)≤30% or new york heart association (nyha) class≥iii. 2. severe renal dysfunction, defined as creatinine clearance rate ≤30 ml/min. 3. cancer. 4. other severe mental illness including schizophrenia, severe dementia, substance abuse, etc. 5. bipolar disorder. 6. ongoing administration of antipsychotic, antidepressant, or antianxiety drugs. 7. serious risk of suicide. 8. severe, life-threatening medical condition (patients cannot participate in the study course). 9. pregnancy and lactation.

Keywords: acute coronary syndrome depression anxiety percutaneous coronary intervention major adverse cardiovascular events
clozapine versus haloperidol for treating the first episode of schizophrenia

Conditions: Schizophrenia

Summary: this study will examine the physical responses brought on by clozapine and haloperidol in people experiencing their first episode of schizophrenia.

this is a longitudinal double blind, 2- 5 year study of the clinical, neuroendocrine and biochemical response to clozapine (cloz) and haloperidol (hal) in a group of "first episode" schizophrenic (rdc) patients. within the protocol, we compare the differential effects of the two drugs over the short term (12 weeks) and the long-term (2-5 years); we evaluate the relationship between change in prolactin level and clinical response of the patients; and we search for biochemical predictors and correlates of clinical response. to achieve the study aims, we employ a drug-washout period, a 12-week acute treatment period; and an 88 - 260 week follow-up period.

Eligibility criteria:
inclusion criteria: * rdc diagnosis of schizophrenia * men and women, without regard to race/ethnicity, * aged 18-45 * acutely psychotic with a score of at least 3 on one of the psychotic scale items of the brief psychiatric rating scale (bprs) (hallucinations, delusions, conceptual disorganization) and a total bprs of \> 21 (on a 0 - 6 scale); * require treatment with neuroleptic drugs on a clinical basis; * the patient (or the patient's authorized legal representative) must understand the nature of the study and sign the informed consent; * be within the first episode of a psychotic disorder; * have a history of neuroleptic treatment of \< 12 weeks; * likely to remain in the study for 2 years. exclusion criteria: * substance dependence in the last six months * history of seizure or blood dyscrasia * major medical illness * pregnancy or lactation

Keywords: clozapine haloperidol schizophrenia
usability of the adepth sensor for bore depth measurements in plate osteosynthesis procedures

Conditions: Fractures, Bone; Osteosynthesis

Summary: the goal of this monocenter randomized pilot study is to investigate the usability of the adepth sensor for bore depth measurements in plate osteosynthesis procedures. the main question it aims to answer is: - what is the usability score of the adepth sensor for bore depth measurements during plate osteosynthesis procedures? participants will receive either bore depth measurements with the adepth sensor or with the manual depth gauge.

to assess the usability score of the adepth sensor for bore depth measurements in plate osteosynthesis procedures. the surgeon and or-assistant will fill in one survey after performing 3 operations with the adepth sensor and one survey after performing 3 operations with the manual depth gauge.

Eligibility criteria:
inclusion criteria: * elective plate osteosynthesis procedure (clavicula, humerus, radius, ulna, femur, tibia, fibula, malleoli) (incl. delayed union, nonunion, malunion) * needed surgical instrument net: 2.4 / 2.7 / 3.5-4.0 / 4.5-5.0-6.5 * adults (≥ 18 years) * written informed consent by patient exclusion criteria: * bone disease (dysplasia's, sarcomas, chondroma's, osteolysis, osteomyelitis) * variable angle plates * corrective surgery after previous plate osteosynthesis procedure or hardware removal
a phase iii study of postoperative early temozolomide treatment plus stupp regimen for newly diagnosed gbm multiforme

Conditions: Anaplastic Oligoastrocytoma; Glioblastoma

Summary: this study was to explore the effectiveness and safety of early tmz chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen.

this study was to explore the effectiveness and safety of early temozolomide chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen. patients were treated with a standard therapy regimen (stupp) plus early postsurgical temozolomide.

Eligibility criteria:
inclusion criteria: age: 18 years to 70 years; newly diagnosed glioblastoma in the supratentorial cerebral hemisphere; gross total resection or large resection of \>70% in imaging studies; eastern cooperative oncology group performance status of 0-2; adequate bone marrow, liver and renal function; ability of subject to understand character and individual consequences of the clinical trial written informed consent; anticipating survival ≥7 months. exclusion criteria: refusal to participate the study; current diagnosis or history of malignancies within the 3-year period preceding enrollment; recurrent or multiple malignant gliomas, including gliomatosis cerebri, or metastatic extracalvarial or subtentorial lesions; known hypersensitivity or contraindication to temozolomide; pregnant or lactating females; malignant tumor other than brain tumor; contraindicated for mri examination; unable to comply with the follow-up studies of this trial; uncontrolled psychotic disorders or epilepsy.

Keywords: glioblastoma multiforme chemotherapy temozolomide