Kornimate/medical-research-clean huggingface dataset:
non-invasive early goal directed therapy in colorectal surgery: a feasibility study

Conditions: Perioperative/Postoperative Complications; C.Surgical Procedure; Digestive System

Summary: the nexfin monitoring system offers a complete non-invasive approach to a continuously estimation of blood pressure, ci and ppv by means of finger-cuff based pulse contour analysis. several clinical investigations have proven reliability and interchangeability of the nexfin technology yielding acceptable results especially regarding the trending abilities. at present there is no evidence available, whether a early goal directed hemodynamic optimization protocol based on a completely non-invasive monitoring technology is able to reduce postoperative complication. therefore, the aim of this single-center study is to compare the clinical outcome and postoperative complications of patients undergoing major colorectal surgery treated with standard of care or with a gdt protocol based on the nexfin technology.

the nexfin™ monitoring system is able to provide continuous beat-to-beat stroke volume index (svi), stroke volume variation (svv), pulse pressure variation (ppv), cardiac index (ci) and arterial pressure by using an inflatable finger cuff. this system consists of a frequency dependent transfer function for calculation of brachial artery pressure from the finger artery pressure. major surgery bares the risk of concealed hypoperfusion and therefore possible mismatch in oxygen delivery and oxygen demand. it must be noted, that the "basic" perioperative monitoring, i.e. electrocardiogram, oxygen saturation and non-invasive or invasive blood pressure measurements is not able to accurately detect hypovolemia and ongoing organ hypoperfusion. perioperatively, patients undergoing major abdominal surgery are prone to high risk of hemodynamic instabilities and consequently relevant changes in oxygen delivery, associated with an increase in postoperative complications and length of stay in hospital. over the last years several studies focused on early goal directed hemodynamic therapy (gdt) with strong proof for the feasibility of such algorithms and the improvement in patient's outcome with respect to certain clinical scenarios.however, there is still a debate regarding an individualized gdt approach, based on pre-procedural defined individualized hemodynamic goals yielded by an advanced haemodynamic monitoring technology. we do have to distinguish which monitoring system, invasive to non-invasive, matches the kind of estimated risk at what time best.

Eligibility criteria:
inclusion criteria: * major abdominal procedures * estimated duration ≥120 minutes * high transfusion probability * anticipated blood loss ≥1000 ml exclusion criteria: * patients less than 18 years old * asa i or iv classification * heart rhythm disorders * advanced peripheral artery occlusive disease * arteriovenous shunts concerning upper extremities * laparoscopic abdominal procedures

Keywords: haemodynamic optimization cardiac index non-invasive pulse pressure variation
feasibility and efficacy of habit for enhancing daily hand-use post stroke

Conditions: Stroke

Summary: this experimental design will assess the feasibility \& initial effectiveness of habit - a novel occupational therapy to increase the daily hand-use of the affected upper extremity post stroke. assessments will be conducted at four time points: baseline, pre, post the habit intervention and follow-up (by phone) .

the goal of this study is to test the feasibility and efficacy of habit (hand activities behavior intervention) in increasing daily hand-use of the affected upper extremity among individuals with good motor ability post-stroke. the aim of habit is to increase the daily use of the weaker hand in everyday activities by improving non-motor components (such as self-efficacy, raising the frustration threshold for performing tasks with the affected upper extremity, and creating opportunities for hand use). habit will include group discussions, analysis of challenges in using the affected upper extremity, home exercises, problem-solving and practice and dual-task activities. the intervention will focus on raising awareness, changing habits, and practicing the use of the affected upper extremity.

Eligibility criteria:
inclusion criteria: * adults aged 18 and above residing in their own homes * hebrew speakers * up to 10 years post-stroke * mild upper extremity motor impairment but still report difficulty using their hand. this will be determined by a total score of 43/66, including the hand subtest score of 7/14 points of the fugl-meyer motor assessment. * no significant cognitive decline (score of 19 and above on montreal cognitive assessment) * able to walk with or without assistive devices * able to provide informed consent by signing a consent form * full function of both hands and independent in daily function prior to stroke exclusion criteria: * other neurological conditions or psychiatrists * with moderate or significant proprioception deficit (thumb localization test \>1)

Keywords: self-efficacy behavior stroke group intervention daily hand-use
procalcitonin-guided treatment on duration of antibiotic therapy and cost in septic patients

Conditions: Sepsis

Summary: this clinical trial is aimed to show a procalcitonin-guided treatment algorithm may shorten duration of antibiotic therapy safely and cost-effectively in sepsis patients of korean icu.


Eligibility criteria:
inclusion criteria: * all patients with suspicious or confirmed sepsis at admission or during stay in icu * patients with antibiotic duration of less than 48 hours before enrollment exclusion criteria: * age less than or equal to 18 years * known pregnancy * specific infections for which long-term antibiotic treatment for 3 weeks more is strongly recommended: infective endocarditis, empyema, osteomyelitis et al. * severe immunocompromised patients : hiv infected patients (cd4 count \< 200 cells/mm3), neutropenia (anc count \< 500/mm3) * presence of do-not-resuscitate order
predictive value of procalcitonin for bacteremia in the icu

Conditions: Sepsis; Procalcitonin

Summary: association between plasma procalcitonin levels and positive blood cultures in critical illness patients in the icu.

rationale: association of procalcitonin levels and blood cultures in critical illness patients on the icu. objective: procalcitonin is an acute phase protein. as part of the acute phase response, procalcitonin is produced during sepsis. previous research shows that procalcitonin is a biomarker for bloodstream infection. however, there is still little known about the value of procalcitonin in diagnostics for micro-organism underlying a sepsis in icu patients. in modern practice, blood cultures are taken when a patient is septic to determine the responsible micro-organism. when procalcitonin is a predictive value for bacteremia in the icu, the number of blood cultures can be reduced. study design: an observational cohort study intervention: for each patient in the icu blood cultures were taken, the procalcitonin level was determined. during 6 months 150 patients will be included. main study parameters/endpoints: this study will examine the predictive value of procalcitonin in blood cultures on the icu.

Eligibility criteria:
inclusion criteria: * patients admitted to the icu * age \> 18 years exclusion criteria: * hemodialysis/ continuous veno-venous hemofiltration

Keywords: intensive care unit
a study to examine the efficacy and safety of pramlintide+metreleptin in obese subjects

Conditions: Obesity

Summary: following screening, eligible subjects will be enrolled into a 6-week low calorie diet (lcd) lead-in period. subjects who lose at least 2% of their body weight at the end of the 6-week lcd lead-in period will be randomized to 1 of 2 treatment arms (pramlintide+metreleptin or placebo) to begin a 16-week treatment period during which the effect on body weight of treatment with pramlintide+metreleptin will be compared to placebo. following the 16 week blinded core treatment period, subjects will discontinue study medication for a period of 12 weeks. following the 12 week off-drug follow-up period, subjects in both groups will initiate a 12 week open-label treatment period with pramlintide+metreleptin. during the 12 week off-drug and 12 week open label treatment periods, subjects will continue to participate in a lifestyle intervention (lsi) program.


Eligibility criteria:
inclusion criteria: * is obese with a bmi ≥35 to ≤45 kg/m2. * has stable body weight (not varying by \>5% within 3 months prior to study start). * meets certain requirements with respect to concomitant medications. * has not smoked or used nicotine-containing products for at least 12 months prior to study start. exclusion criteria: * has not been enrolled in a weight loss program within 2 months prior to study start.

Keywords: pramlintide metreleptin obesity amylin takeda
studying chromosomes in samples from younger patients with neuroblastoma

Conditions: Neuroblastoma

Summary: this research studies chromosomes in samples from younger patients with neuroblastoma. studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer.

objectives: i. determine the impact on overall survival of patients with non-mycn neuroblastoma below 18 months of age as compared to neuroblastoma patients above 18 months of age. outline: archived dna samples are analyzed for segmental chromosome aberrations by multiplex ligation-dependent probe amplification (mlpa), a polymerase chain reaction (pcr)-based technique. the following genomic regions are being studied: 1p, 1q, 3p, 4p, 7q, 9p, 11q, and 17q, as are the copy numbers of mycn, nag, ddx1, and alk genes.

Eligibility criteria:
inclusion criteria: * samples from neuroblastoma patients who, according to risk stratification, did not receive cytotoxic treatment and did never receive chemotherapy and are in complete response (cr) or patients who, according to risk stratification, did not receive cytotoxic treatment initially, but had a localized or a systemic (stage ms or m) relapse with or without following chemotherapy * low-risk children oncology group (cog) designation: no initial cytotoxic treatment, any stage, any age, any outcome * dna from untreated neuroblastoma tumor samples (from patients in the age group below and from patients in the age group above 1.5 years of age) available from the cog, europe, israel, and japan * no mycn amplification * no schwann cell stroma-rich tumors * no tumor cell content below 60% * no dot * no patients diagnosed before 1997 and after 2005 * no lack of follow-up data * see disease characteristics * no initial cytotoxic treatment
the effect of vitamin d repletion on kidney stone risk

Conditions: Calculi

Summary: examine the effect of nutritional vitamin d repletion on urinary calcium excretion and kidney stone burden in calcium kidney stone formers

the investigators plan to conduct a clinic-based interventional study of 50 patients followed at miriam hospital kidney stone clinic with history of nephrolithiasis, urinary calcium excretion between 150 and 400 mg/day, and 25-vitamin d deficiency/insufficiency (defined as serum level ≤ 30ng/ml). the intervention is oral ergocalciferol 50,000 iu per week for 12 weeks (repletion course). after that, the same repletion course will be repeated if serum 25-vitamin d remains ≤ 30ng/ml or drops to ≤ 30ng/ml anytime during the study. otherwise, a maintenance dose of cholecalciferol 1,000 iu daily or ergocalciferol 50,000 iu monthly will be prescribed for the rest of the study. each participant will serve as his own control. the outcome is the change in urinary calcium excretion and stone burden assessed by renal ultrasound. the planned study duration is 12 months. the investigators will have greater than 95% power to detect a 10% increase in 24-hour urinary calcium.

Eligibility criteria:
inclusion criteria: * history of nephrolithiasis * 25(oh)d deficiency (defined as serum level ≤ 30ng/ml) within 3 months of enrollment * 24-hour urinary calcium excretion \> 150 mg/day and \< 400 mg/day (measured less than 2 months prior to study enrollment) exclusion criteria: * known uric acid, cystine, or struvite stone disease * hypercalcemia (serum calcium \>10.4 mg/dl within the past 12 months) * gross hematuria within the past 6 months * acute stone event within the past 1 month * recent stone intervention within the past 1 month * suspected or known secondary causes of hypercalciuria such as primary hyperparathyroidism, sarcoidosis, hyperthyroidism, or malignancy (except non-melanoma skin cancer) * addition or dose change of medicines potentially affecting urinary calcium since enrollment 24-hour urine collection (including diuretics, magnesium supplements, potassium supplements, potassium citrate, and vitamin d supplementation) * pregnancy
assessment of mediastinal masses with diffusion weighted mr imaging

Conditions: Mediastinal Tumor

Summary: differentiation between benign and malignant mediastinal tumors as well as characterization and grading of malignancy which is essential for treatment planning as well as for prognosis

differentiation between benign and malignant mediastinal tumors as well as characterization and grading of malignancy is essential for treatment planning as well as for prognosis . mri presents valuable diagnostic information in assessing the mediastinum. in addition, special applications have been developed over recent years diffusion-weighted magnetic resonance imaging is one such technique the advent of echo-planar imaging technique has rendered diffusion weighted imaging of the abdomen and thoracic cavity possible . quantitative assessment of the mediastinal mass is possible by calculation of apparent diffusion co-efficient value ,which is related to the proportion of extracellular and intracellular component. the apparent diffusion co-efficient is inversely correlated with tissue cellularity. it is lower in viable tumor tissue with densely packed diffusion-hindering obstacles than in tissue with less densely packed obstacles such as tumor necrosis and benign tissue .

Eligibility criteria:
inclusion criteria: * any age groups * diagnosis of mediastinal mass (by multislice computed tomography). exclusion criteria: * chemotherapy radiotherapy. * thoracic surgery. * cystic mass . * mass with large amount of necrosis or calcification. * contraindication of mri (e.g. pacemakers , claustrophobia).

Keywords: mediastinal masses mri diffusion
safety and efficacy study to evaluate the effect of slv320 on renal function in patients with worsening heart failure

Conditions: Acute Decompensated Heart Failure; Renal Dysfunction

Summary: the purpose of this study is to determine the efficacy and safety of iv slv320 in acute heart failure patients with renal dysfunction.

the purpose of this study is to determine the efficacy and safety of iv slv320 in acute heart failure patients with renal dysfunction.

Eligibility criteria:
inclusion criteria renal dysfunction defined as estimated egfr of 20-80 ml/min; history of systolic or diastolic chronic heart failure of at least 14 days duration for which loop diuretic therapy has been prescribed; clinical evidence for volume overload; bnp ≥ 500 pg/ml or nt-pro-bnp \> 2000 pg/ml; hospitalization. exclusion criteria have low output syndrome, defined as having the need for treatment with i.v. inotropes or vasopressors; need mechanical ventilation; have significant stenotic valvular disease (severe aortic or mitral stenosis); have myocardial infarction or hemodynamically destabilizing significant arrythmias (ventricular tachycardia, bradyarrythmias with slow ventricular rate \[\ 120 bpm), or electrocardiographic evidence of 2nd degree heart block (mobitz type ii) or 3rd degree av-block in the absence of a pacemaker, within 30 days of screening; have acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy

Keywords: slv320; acute decompensated heart failure (adhf); chronic heart failure; renal failure; i.v. doses; hospitalization
safety, tolerability and effectiveness of nuedexta in the treatment of pseudobulbar affect (pba)

Conditions: Pseudobulbar Affect (PBA); Stroke; Dementia; Traumatic Brain Injury (TBI)

Summary: the objectives of the study are to evaluate the safety, tolerability, and effectiveness of nuedexta capsules containing 20 mg dm (dextromethorphan)/10 mg q (quinidine) for treatment of pseudobulbar affect (pba) in patients with prevalent conditions such as dementia, stroke, and traumatic brain injury (tbi)over a 12 week period.

this will be an open-label, multicenter, study in patients with pba and dementia, stroke or tbi. patients with a clinical diagnosis of pba and who meet all other inclusion and exclusion criteria will be eligible to participate and receive nuedexta for 12 weeks. males and females patients with a minimum age of 18 years, a clinical diagnosis of pseudobulbar affect and a documented diagnosis of neurologic disease or brain injury, will be enrolled in this study. the primary effectiveness endpoint is the mean change in the center for neurologic study-lability scale (cns-ls). secondary objectives include measures to evaluate treatment outcomes.

Eligibility criteria:
inclusion criteria: * center for neurologic study-lability scale (cns-ls)score of 13 or greater * clinical diagnosis of pseudobulbar affect (pba) * documentation of neurologic disease or brain injury exclusion criteria: * unstable neurologic disease * severe dementia * stroke within 3 months * penetrating tbi * contraindications to nuedexta * severe depressive disorder
effectiveness of an hiv vaccine in hiv-negative adults in north america who are at risk of hiv infection

Conditions: HIV Infections; HIV Seronegativity

Summary: the purpose of this study is to see if an hiv vaccine, aidsvax b/b, can protect adults who are at risk from becoming infected with hiv. patients who become infected despite immunization will be studied to see if receiving the vaccine before becoming infected will help keep hiv levels (viral load) low.

volunteers receive 7 blinded, intramuscular vaccinations (at months 0, 1, 6, 12, 18, 24, 30) containing either the aidsvax b/b vaccine or a placebo (aluminum adjuvant only). volunteers are randomized in a 2 to 1 vaccine-to-placebo ratio. hiv-uninfected persons are followed for a total of 16 visits beginning at screening and continuing until month 36. patients who become hiv infected during study are followed every 4 months for at least 24 months.

Eligibility criteria:
exclusion criteria you will not be eligible for this study if you: * use injection drugs. * have a history of any serious diseases or conditions, including lymphoma. * have ever received an hiv vaccine. * have taken post-exposure treatment to prevent hiv infection within 4 weeks prior to study entry. * are planning to take other hiv vaccines during this study. * are pregnant. * have taken certain medications or received certain therapies, including chemotherapy and radiation. * have received certain vaccines within 2-4 weeks prior to study entry. you may be eligible for this study if you: * are hiv-negative. * are between 18 and 60 years old. * are available for 3 years of follow-up. * agree to use effective methods of birth control during the study and for 90 days after. * are one of the following: * a woman who is currently in a sexual relationship with an hiv-positive man. * a woman who has had more than one male partner and at least one sexually transmitted disease (std) within the past 12 months. * a man who has sex with men and has had anal intercourse within the past 12 months. (you will not be eligible if you have been in the same relationship with only one hiv-negative man for at least 12 months.)

Keywords: hiv-1 dose-response relationship, drug acquired immunodeficiency syndrome aids vaccines sexually transmitted diseases risk factors hiv seronegativity antigens, viral alum compounds
irofulven in treating patients with metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of irofulven in treating patients with metastatic colorectal cancer.

objectives: i. assess the antitumor activity of 6-hydroxymethylacylfulvene (mgi-114) when given daily for 5 days every 28 days to patients with metastatic adenocarcinoma of the colon or rectum. ii. evaluate the qualitative and quantitative toxicities of mgi-114 given on this schedule in this patient population. outline: patients receive 6-hydroxymethylacylfulvene (mgi-114) iv over 5 minutes daily for 5 consecutive days. courses are repeated every 28 days. the minimum treatment period is 2 courses. treatment continues indefinitely in the absence of unacceptable toxic effects or disease progression. patients are followed at the end of every other course while on the study, and then every 3 months thereafter until death. projected accrual: a total of 18-35 patients will be accrued for this study within 6-10 months.

Eligibility criteria:
disease characteristics: histologically confirmed metastatic adenocarcinoma of the colon or rectum bidimensionally measurable lesions sentinel lesions outside the field of any prior radiation therapy no confirmed or suspected brain metastases patient characteristics: age: 18 and over performance status: zubrod 0-1 life expectancy: at least 12 weeks hematopoietic: granulocyte count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.5 mg/dl renal: creatinine no greater than 1.5 mg/dl creatinine clearance at least 60 ml/min cardiovascular: no active congestive heart failure no uncontrolled angina at least 6 months since prior myocardial infarction no uncontrolled hypertension other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception no concurrent serious infection no other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix no overt psychosis or mental disability no life threatening illness (unrelated to tumor) prior concurrent therapy: biologic therapy: no concurrent biologic therapy chemotherapy: no prior chemotherapy for metastatic disease at least 6 months since prior adjuvant chemotherapy no other concurrent chemotherapy endocrine therapy: not specified radiotherapy: see disease characteristics at least 4 weeks since prior radiation therapy and recovered no concurrent radiotherapy surgery: at least 4 weeks since prior major surgery and recovered no concurrent surgery other: at least 28 days since prior administration of any investigational drug no other concurrent anticancer therapy

Keywords: stage iv colon cancer stage iv rectal cancer recurrent colon cancer recurrent rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum 6-hydroxymethylacylfulvene mgi-114 irofulven