Kornimate/medical-research-clean huggingface dataset:
milrinone versus placebo in patients with septic shock

Conditions: Septic Shock; Cardiac Output

Summary: sepsis is one of the most serious healthcare problems, worldwide, and financial burdens. the overall mortality of severe sepsis/septic shock was 44.5-52.6%. a common cause of death is refractory shock and multi-organ failure. myocardial dysfunction is a relatively common complication of septic shock. this causes a decrease in the amount of cardiac output, resulting in insufficient blood supply to the organ and multi-organ failure and lead to death early goal-directed therapy began to use dobutamine in patients with septic shock sepsis survival campaign guideline 2016 recommended drug is dobutamine and an alternative drug is milrinone in septic shock patients with clinical signs of poor tissue perfusion.

according to several studies, the use of dobutamine increases the amount of cardiac output but it has also been reported to increase mortality rates too. there are few studies of milrinone in patients with septic shock.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years old * diagnosis septic shock from the definition of sepsis iii in intensive care unit at siriraj hospital and hat-yai hospital * receive fluid resuscitation at least 30 ml/kg and/or vasopressor until mean arterial pressure ≥ 65 mmhg * persistence lactate \>2mmol/l at 6th hour after resuscitation * urine output \< 0.5 ml/kg at 6th hour after resuscitation * left ventricular ejection fraction (lvef) \< 40 % exclusion criteria: * chronic kidney disease stage 5 and denied renal replacement therapy * life-threatening tachyarrhythmia before enrolled e.g. ventricular tachycardia, ventricular fibrillation * patient sign do-not-resuscitation and terminally ill

Keywords: milrinone septic shock cardiac output poor tissue perfusion
safety and performance of softox wound irrigation solution (swis) in acute wounds

Conditions: Acute Wounds

Summary: this pilot study evaluates safety and performance of the medical device, softox wound irrigation solution (swis), in a model for acute wounds.

this is a pilot study with an open-label, exploratory study design with the aim to document preliminary safety and performance of the softox wound irrigation solution while used as intended by the manufacturer, i.e. as an irrigation solution for mechanical rinsing of breached or compromised skin as a result from acute wounds. this first-in-man study will give valuable information on the feasibility of the treatment with the softox wound irrigation solution to prepare for continuous studies in clinically significant settings prior ce marking. the investigation population will consist of 12 subjects undergoing split skin graft transplantation for treating chronic leg ulcers and that are fulfilling the eligibility criteria for the clinical investigation. the softox wound irrigation solution will be applied on the donor site of the split skin graft which is a representative model of acute wounds in a controlled setting. all subjects will be followed up for 21 days. the duration of the investigation is estimated to 4 months.

Eligibility criteria:
inclusion criteria: 1. age 18 and older 2. non-healing, leg ulcers, that are scheduled for an operation with excision of the chronic leg ulcer and split skin transplantation 3. been informed of the nature, the scope and the relevance of the clinical investigation 4. voluntarily agreed to participation and has duly signed the informed consent form exclusion criteria: 1. participating in any other clinical investigation 2. on systemic immunomodulating drugs 3. on systemic steroid treatment up to four (4) weeks prior to study inclusion 4. on strong pain medication (e.g. opioids) 5. severe neuropathy (or dysesthesia on the donor site) 6. pregnancy 7. dementia 8. allergy to polyurethane foam, hypochlorous acid, acetic acid or any other remedies/material used in the clinical investigation 9. not able to read or understand danish 10. any other conditions that as judged by the investigator may make follow-up or investigation inappropriate 11. that according to the declaration of helsinki is deemed unsuitable for study enrolment
a safety and efficacy study of symbicort turbuhaler compared with standard chronic obstructive pulmonary disease (copd) treatment in japan

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to evaluate the safety and efficacy of symbicort turbuhaler compared to standard copd treatment during one year in japanese patients with copd.


Eligibility criteria:
inclusion criteria: * a current clinical diagnosis of copd according to the guidelines (gold, jps) * documented copd symptoms for more than 2 years * pre-bronchodilator fev1≦50% of predicted normal value, and post-bronchodilator fev1/fvc\<70% exclusion criteria: * history and/or current clinical diagnosis of asthma and atopic diseases such as allergic rhinitis * subjects with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator * copd exacerbation during the run-in period or within 4 weeks prior to registration, requiring hospitalization and/or treatment with systemic steroids.

Keywords: symbicort safety efficacy copd japanese
effects of an integrated multimodal lifestyle intervention for management of violence in schizophrenia

Conditions: Schizophrenia

Summary: total cholesterol levels and other lipids are associated with violence in psychiatric patients. there is a paucity of studies on preventive interventions. in this study, an integrated multimodal lifestyle intervention (mlifei) for management of repetitive violence in schizophrenia is proposed. a controlled clinical trial was carried out to evaluate the effects of mlifei on management of repetitive violence through regulation of serum lipids, tc in particular, to the recommended levels in schizophrenia. the investigators examined whether the mlifei could: 1. regulate or balance lipid profiles; 2. reduce violence risk; 3. improve impulsivity; and 4. improve general cognitive functioning.

total cholesterol levels and other lipids are associated with violence in psychiatric patients. there is a paucity of studies on preventive interventions. in this study, an integrated multimodal lifestyle intervention (mlifei) for management of repetitive violence in schizophrenia is proposed. a controlled clinical trial was carried out to evaluate the effects of mlifei on management of repetitive violence through regulation of serum lipids, tc in particular, to the recommended levels in schizophrenia. the investigators examined whether the mlifei could: 1. regulate or balance lipid profiles; 2. reduce violence risk; 3. improve impulsivity; and 4. improve general cognitive functioning. the multimodal lifestyle intervention included psychoeducation, lifestyle modification and health promotion and exercise. outcome measures comprised lipid profiles, body mass index and violence-related parameters.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of schizophrenia for more than 2 years * psychiatrically hospitalized * repetitive violence within one year * ambulatory * having basic literacy * more than 20 years old * less than 65 years old exclusion criteria: * clinical psychiatric diagnosis other than schizophrenia * physical co-morbidity or life-threatening illnesses that may impact on lipid homeostasis * dietary restrictions for physical condition * pregnancy * reported disabilities * impairments or health illness/problems that significantly limited their ability to perform the intervention such as severe arthritis, uncorrected visual or hearing impairments, developmental disability, or signs of intellectual disability.

Keywords: lifestyle intervention management of violence lipid profile
study to evaluate efficacy of aflibercept in neovascular age-related macular degeneration patients non responders to anti-vascular endothelial growth factor

Conditions: Wet Macular Degeneration

Summary: patients with neovascular age-related macular degeneration who do not respond to usual treatment with conventional medications may respond to a new drug of the same class which is designed to block a larger fraction of proangiogenic factors.


Eligibility criteria:
inclusion criteria: * signed informed consent * men and women ≥ 50 years of age. * any choroidal neovascular membranes (cnvm) lesion (occult, minimally classic or classic) secondary to age-related macular degeneration * early treatment diabetic retinopathy study (etdrs) best-corrected visual acuity of: 20/32 to 20/320 (letter score of 73 to 25) in the study eye. * able to return for all clinic visits and complete all study-related procedures. * absence of other ocular diseases that could affect visual acuity. * patients without optimal response to ranibizumab or bevacizumab defined as: * patient with significant persistent or recurrent fluid (intraretinal or subretinal) on oct or any leakage on fluorescein angiography despite at least 4 injections within last 6 months, being the last oct with presence of fluid within the 6 weeks after last treatment with ranibizumab or bevacizumab. * patient with significant persistent or recurrent fluid (intraretinal or subretinal) on oct or any leakage on fluorescein angiography despite three monthly treatment with ranibizumab or bevacizumab. exclusion criteria: * no scar, fibrosis, or atrophy involving the center of the fovea * no retina pigment epithelium (rpe) rip/tear involving the central fovea * participation in another simultaneous interventional clinical trial * prior treatment with anti-vegf or steroids therapy in the study eye within 28 days of baseline * prior treatment with photodynamic therapy (pdt) * intraocular surgery (including cataract surgery) in the study eye within 2 months preceding baseline * history of vitrectomy surgery, submacular surgery, or other surgical intervention for amd in the study eye * active intraocular inflammation in the study eye * history of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment. * unable to undergo fluorescein angiography or fundus photography because of uncontrolled allergies
outcomes of perioperative pregabalin on total knee arthroplasty

Conditions: Pain, Postoperative

Summary: this study aims to provide high quality evidence from a double-blinded, randomized controlled trial on the efficacy of perioperative pregabalin in reducing morphine requirements, improving pain scores and reducing chronic neuropathic pain when compared with placebo for primary total knee arthroplasty. it hence aims to improve on choice of analgesia adjuncts for total knee arthroplasty.

aims: whether pregabalin given preoperatively and for one week postoperatively in addition to patient-controlled analgesia (pca) morphine is effective in reducing morphine requirements, improving pain scores and reducing chronic neuropathic pain when compared with placebo for primary total knee arthroplasty. methodology: a single-centre double-blind randomized controlled trial in patients undergoing primary total knee arthroplasty. all subjects receive pca morphine, paracetamol 1g every six hours, etoricoxib 120mg once daily postoperatively. subjects receive either pregabalin 75mg po preoperatively followed by 75mg om and 25mg on for two days postoperatively or matching placebo. the primary outcome is cumulative morphine consumption at 72 hr following surgery. secondary outcome measures included pain scores, knee range of motion and patient satisfaction.

Eligibility criteria:
inclusion criteria: * patients undergoing primary total knee arthroplasty exclusion criteria: * revision or bilateral arthroplasty, significant renal or hepatic impairment, documented allergy or intolerance to nsaids, paracetamol, morphine or pregabalin, chronic pain syndrome treated with chronic opioids, obstructive sleep apnea not treated with continuous positive airway pressure, seizures, breastfeeding, inability to use patient-controlled analgesia.
reduced-intensity conditioning allogeneic hematopoietic cell transplantation

Conditions: Myelodysplastic Syndrome

Summary: the purpose of this study is to evaluate the feasibility and efficacy of reduced-intensity conditioning allogeneic hct followed by prophylactic dose-escalating dlis in patients with higher risk mds.

conditioning therapy * busulfan 3.2 mg/kg/d on d-7 to -6 * fludarabine 30 mg/m2 on d-7 to -2 * atg 1.5-3.0 mg/kg/d on d-3 to -1 * methylpred 2 mg/kg/d on d-4 to -1 mobilization and harvest * donor * g-csf 10 mcg/kg/d s.c. on d-3 to 0 * harvest of pbmcs on d 0 to +1 infuse g-pbmcs on d 0 to d+1. * donor g-pbmc infusion gvhd prophylaxis * cyclosporine 1.5 mg/kg i.v. q 12 hrs beginning on d-1 and changed to oral dosing (with twice the i.v. dose) when oral intake is possible. tapered beginning between d+30 and d+60. * methotrexate 15 mg/m2 i.v. on d+2, and 10 mg/m2 i.v. on d+4 and d+7 prophylactic dose-escalating dlis * begin at d+120 or at least 2 wks after ist discontinuation. * no evidence of recurrence or gvhd cd3+ cell dose increment q 4 wks 4three dose levels

Eligibility criteria:
inclusion criteria: 1. patients with higher risk mds including chronic myelomonocytic leukemia * raeb-1 or raeb-2 * ipss intermediate-2 or high risk category * chronic myelomonocytic leukemia 2. patients with appropriate hematopoietic cell donor * hla-matched sibling * hla-matched unrelated donor * hla-mismatched familial donor 3.16 years old or older exclusion criteria: * • presence of significant active infection * presence of uncontrolled bleeding * any coexisting major illness or organ failure * patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible

Keywords: higher risk mds
a study of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis

Conditions: Colitis, Ulcerative

Summary: the purpose of this study is to evaluate the efficacy and safety of jnj-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of ulcerative colitis (uc) for at least 3 months prior to baseline * moderately to severely active uc as assessed by the modified mayo score * demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity * if female and of childbearing potential, must meet the contraception and reproduction requirements exclusion criteria: * has severe extensive colitis as defined in the protocol * extent of inflammatory disease limited to the rectum * participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or crohn's disease (cd) * has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer * currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)
study of 18f-dcfpyl pet/ct imaging in patients with prostate cancer

Conditions: Prostate Cancer

Summary: this study evaluates the rate of radiological disease progression with the new 2nd generation positron emission tomography (pet) radiopharmaceutical, 18f-dcfpyl, in patients with metastatic castration (mcrpc) and non-metastatic (nmcrpc) castration resistant prostate cancer who have evidence of biochemical (psa) disease progression without evidence of radiological disease progression on conventional standard radiologic testing (99mtc-methylene diphosphonate bone scan and ct).


Eligibility criteria:
inclusion criteria: * histological confirmation of prostate cancer * patients receiving androgen deprivation treatment (adt) with gnrh analogs, gnrh antagonists or bilateral orchiectomy of any duration. * cohort a: nmcrpc (status post- primary treatment with radical prostatectomy, radiation of any type or both) * negative 99mtc-methylene diphosphonate bone scan and ct of the chest abdomen and pelvis within 6 weeks of 18f-dcfpyl pet/ct * treatment with adt with or without a second line novel ar targeted treatment (abiraterone, enzalutamide, or both) or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted) for ≥ 12 months. * rising psa ≥ 10 ng/ml (confirmed by 2 determinations one week apart) * psadt ≤ 9 months * cohort b: mcrpc * treatment with adt with or without abiraterone and or enzalutamide or both for ≥ 6 months and/or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted). * psa ≥ 2.0 ng/ml confirmed x 1 week apart, any psadt * patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility. * no new therapeutic interventions planned or scheduled to be instituted prior to the course of this study both on cohorts a and b before conventional radiologic progression is evidenced. * patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures. exclusion criteria: * patient will be excluded from enrollment if he had a radioisotope within 5 physical half-lives prior to pet imaging

Keywords: 18f-dcfpyl pet/ct pyl psma
serial mpmri (multi parametric magnetic resonance imaging) scanning in prostate cancer after androgen deprivation therapy and radiotherapy

Conditions: Prostate Cancer

Summary: the evaluation of the radiological changes in localised or locally advanced prostate cancer after androgen deprivation therapy and external beam radiotherapy using multi-parametric mri (multi parametric magnetic resonance imaging) and verdict (vascular, extracellular and restricted diffusion for cytometry in tumours) sequences.

external beam radiotherapy (ebrt) fails to eradicate prostate cancer in 24-33% of cases. response is monitored solely by testing serum prostate specific antigen (psa), with biochemical failure following radiotherapy defined as a prostate specific antigen (psa) level of 2 ng/ml above the nadir. t2 and dynamic contrast enhanced (dce) mri have been shown to be able to detect the recurrence of prostate cancer following radiotherapy. changes seen in apparent diffusion coefficient (adc) variables post-treatment have potential use in monitoring disease response to radiotherapy but the natural history of these changes during and after treatment remains uncertain and warrants further investigation. this study investigates the feasibility of using multi-parametric mri (mpmri) and novel diffusion-weighted sequences called verdict (vascular, extracellular and restricted diffusion for cytometry in tumours) at various stages during the treatment of prostate cancer with radiotherapy. patients will be first scanned before androgen deprivation therapy (adt) starts, then 3 weeks before the start of radiotherapy, again in week 6 of radiotherapy and once more 6 months after the end of radiotherapy. in addition, all patients entered into the study will already have had a mpmri scan prior to prostate biopsy as part of their standard care. multi-parametric mri and verdict sequences may reveal changes in the tumour and normal prostate before a detectable psa increase. this could allow for their use in response assessment following radiotherapy and androgen deprivation treatment. if such clinical utility is proven, referral for salvage treatment using high intensity focussed ultrasound (hifu), cryotherapy or salvage radical prostatectomy may be expedited.

Eligibility criteria:
inclusion criteria: 1. targeted or concordant biopsy confirmed prostate cancer 2. pre-biopsy mpmri scan of the prostate undertaken at university college london hospital (uclh) 3. agrees to have adt and ebrt exclusion criteria: 1. treatment within the previous 6 months with any form of hormones (including 5-alpha reductase inhibitors) 2. evidence of metastatic disease 3. prior local intervention to the prostate 4. unable to give informed consent 5. any prosthesis (including hip replacements) which could cause artefacts degrading the quality of the imaging 6. contraindication to gadolinium contrast agent 7. unable to tolerate an mri

Keywords: mri radiotherapy
bilateral essential tremor treatment with fus

Conditions: Essential Tremor

Summary: combined phase ii/iii, multi-center, prospective, single-blinded trial. ten (10) patients with who previously underwent successful and uncomplicated mrgfus thalamotomy for essential tremor will undergo a contralateral treatment. the incidence of side effects will be determined at 1 and 3 months postoperatively, graded per the ctcae v5 and analyzed by a data safety monitoring board. upon successful review, this phase ii trial will be converted to a phase iii trial of utility that will enrol 40 additional patients. the primary outcome will be the change in quest score at 12 months postoperatively, as well as a patient-reported assessment of health utility. secondary outcomes will include objective tremor, gait and speech assessments (filmed and scored by blinded evaluators), as well as quality of life questionnaires and adverse events questionnaires. outcomes will be assessed immediately after the procedure, as well as 1, 3, 12, 24 and 36 months post-operatively.


Eligibility criteria:
inclusion criteria: * patients must be ≥ 18 years * the patient has a primary diagnosis of et or et plus confirmed by a movement disorder neurologist; * the patient previously underwent a mrgfus (\> 6 months ago); * the tremor on the untreated side negatively impacts the patients' quality of life; * the patient wants treatment of the contralateral side. exclusion criteria: * clinically relevant gait and/or balance impairment (e.g. wide-based, more than 2 falls/months, wheelchair, walker, cane use) * clinically relevant speech impairment (e.g. impairment of intelligibility) * inability to comply with the follow-up schedule; * refusal of the treating physician.

Keywords: high-intensity focused ultrasound ablation