Kornimate/medical-research-clean huggingface dataset:
impact of clinical pharmacy services provided for patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: enrolment of clinical pharmacy services in ra patients as a part of health care system has been investigated at many studies but not investigated in active ra patients before. this study aimed to detect drug therapy-related problems (dtrps) in active rheumatoid arthritis (ra) patients and investigate the impact of clinical pharmacist interventions on the patient clinical outcome and quality of life (qol). methods:prospective, randomized controlled study to be carried out at rheumatology outpatient clinic, ain shams university hospitals on 50 patients with active ra for 6 months.determine if any drug therapy problems are present.develop a plan of care that includes interventions to resolve drug therapy problems, achieve goals of therapy, and prevent drug therapy problems. questionnaires was used to measure functional status in ra patients using health assessment questionnaire (haq) and assess self-reported quality of life in patients with (ra) using rheumatoid arthritis quality of life questionnaire (raqol) and measure adherence using the 4-item morisky green levine medication adherence scale and disease activity score-28 was used as an objective method to assess ra disease activity.


Eligibility criteria:
inclusion criteria: * patients aged 18-60 years old * fulfillment of the american college of rheumatology /european league against rheumatism (2010 acr/eular ) diagnostic criteria for ra. * patients with active ra(defined by das28 score \< 5.1) exclusion criteria: * patients with cognitive impairment. * the presence of hepatic or renal disease. * the presence of other rheumatic and connective tissue disorders.
this prospective study has 2 objectives: first, to assess the post-obturation pain utilizing bioceramic sealer and one cone technique. second, to compare the intensity of post-obturation pain following unintentional sealer extrusion

Conditions: Pain, Postoperative; Endodontic Overfill

Summary: root canal treatment is essential step to eliminate pain and preserve tooth structures. however, errors could happen unintentionally such as ledge, perforation and sealer extrusion. pain through an endodontic treatment is one of the elements that most of the patients seek treatment to be relived. one the current systemic review analyzed the pain after root canal treatment could be up to half the patients. the purpose of this study is to evaluate and record the postoperative pain among patients who are undergoing root canal treatment.


Eligibility criteria:
"inclusion criteria": * primary root canal * asymptomatic tooth with or without apical radiolucency * patient older than 18 and younger than 70 * american society of anesthesiology (asa) class i or ii "exclusion criteria": * patient with preoperative pain * periodontal probing more than 5mm * when patency could not be achieved * pregnant patient., * patients who could not properly follow the instructions for filling the visual analog card (vas) were excluded. * previously treated or initiated

Keywords: sealer extrusion postoperative pain
comparison of two stapled antimesenteric anastomosis for cd: a randomized control trial study

Conditions: Crohn Disease; Recurrence

Summary: the postoperative recurrence of crohn's diseases (cd) remains high. stapled anti-mesenteric functional end-to-end anastomosis was safe for cd patients. its impact on the postoperative recurrence of cd was unknown. whether it is superior than the conventional anastomosis (stapled antimesenteric isoperistaltic side-to-side anastomosis) needs explored. the trial aims to compare the different impacts of the two antimesenteric anastomosis configurations on the anastomotic recurrence following bowel resection.


Eligibility criteria:
inclusion criteria: * patients with crohn's disease needing bowel resection and anastomosis; * ileocolic anastomosis； * written consent acquired exclusion criteria: * patients underwent enterostomy; * small bowel anastomosis; * anticipating other trial.
efficacy, safety and tolerability study of subcutaneous c.e.r.a. in pre-dialysis participants with chronic renal anemia

Conditions: Anemia

Summary: this single arm study will assess the efficacy, safety and tolerability of subcutaneous methoxy polyethylene glycol-epoetin beta (c.e.r.a.) for maintenance of hemoglobin levels in pre-dialysis participants with chronic renal anemia. participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous injections of c.e.r.a. with the starting dose of 120, 200 or 360 micrograms (mcg) derived from the dose of darbepoetin alfa or epoetin alfa in the week preceding study start.


Eligibility criteria:
inclusion criteria: * chronic renal anemia * hemoglobin concentration between 10.5 gram per deciliter (g/dl) and 12.5 g/dl * adequate iron status (serum ferritin greater than \[\>\] 100 nanogram per milliliter and transferrin saturation \>20 percent \[%\] or hypochromic red cells less than \[\<\] 10%) * continuous subcutaneous maintenance darbepoetin alfa therapy with same dosing interval during previous 2 months exclusion criteria: * transfusion of red blood cells during previous 2 months * poorly controlled hypertension requiring hospitalization or interruption of darbepoetin alfa treatment in previous 6 months * acute or chronic bleeding * active malignant disease (except non-melanoma skin cancer)
markers and calculation of cardiovascular risk in the distinct phenotypes of polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) is the most common endocrine disorder and cause of anovulatory infertility among reproductive aged women. according to the revised criteria of 2003, four distinct phenotypes of pcos can be diagnosed. however, there are emerging evidence supporting the existence of different levels of cardiometabolic risk between the four phenotypic groups of the syndrome. the purpose of this study is to determine the cardiovascular risk of i) normoweight and ii)overweight plus obese women of every one of the four phenotypes of the syndrome as well as the levels of low inflammation serum markers and the possible correlations of the between the outcomes.


Eligibility criteria:
inclusion criteria: * diagnosis of pcos (criteria 2003) * healthy controls exclusion criteria: * any condition mimicking pcos * any systematic disease

Keywords: pcos hsc-rp lp-pla2 cardiovascular risk
preventing cardiovascular collapse with vasopressors during tracheal intubation

Conditions: Critical Illness; Respiratory Failure

Summary: tracheal intubation (ti) is associated with a high risk of adverse events in critically ill patients and peri-intubation hemodynamic collapse is the most commonly observed. the primary aim of the prevention trial is to compare the effect of the pre-emptive use of noradrenaline versus no peri-intubation use of noradrenaline on incidence of cardiovascular collapse following ti in adult critically ill patients. patients with absolute indication or contraindication to vasopressor support will be excluded from this trial. patients will be randomized 1:1 to a continuous infusion of noradrenaline started before induction titrated according to baseline mean arterial pressure. the primary outcome will be the incidence of cardiovascular collapse. secondary outcomes will include lowest systolic blood pressure and cardiac arrest within 30 minutes from intubation.

prevention trial is a pragmatic, multi-center, un-blinded, parallel group, randomized study comparing the pre-emptive use of noradrenaline to no-vasopressors during the peri-intubation period of adult critically ill patients. investigators hypothesize that the pre-emptive administration of noradrenaline would mitigate the incidence and severity of peri-intubation cardiovascular collapse. the study will include adult (18 yrs or older) critically ill patients needing in-hospital intubation, excluding patients with absolute indication or contraindication to vasopressors. patients will be randomized to receive either a continuous infusion of noradrenaline started at least 8 minutes before induction vs no vasopressors during the peri-intubation period. all co-interventions will be provided according to clinician's judgement. the primary outcome of the study will be a composite of map \< 60 mmhg or cardiac arrest. secondary outcomes will include lowest systolic blood pressure \< 30 minutes from induction, change in systolic blood pressure from baseline to the lowest value within 30 minutes from induction and cardiac arrest.

Eligibility criteria:
inclusion criteria: * patient is admitted or scheduled for admission to a participating study hospital * planned procedure is tracheal intubation and planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit * critical illness (i.e. life-threatening condition with intubation required for cardiorespiratory failure or neurological impairment) * administration of sedation (with or without neuromuscular blockade) is planned * age 18 years or older exclusion criteria: * no vasopressors/inotropes at the moment of screening for eligibility * map \ 120 mmhg at the moment of screening for eligibility * urgency of intubation precludes safe performance of study procedures * intubation performed during cardiopulmonary resuscitation of a patient in cardiac arrest * enrolled in another clinical trial that is unapproved for co-enrollment * pregnant or suspected pregnancy

Keywords: tracheal intubation
validation of a delirium monitor

Conditions: Delirium

Summary: delirium is a common disorder in hospitalized patients, nevertheless it is poorly recognized by physicians and nurses, even when screening instruments are used. electroencephalography (eeg) appears to be a sensitive tool for the diagnosis of delirium. however, standard eeg recording with 25 electrodes is labor intensive. we have previously showed that a brief eeg registration with three electrodes and automatic processing can distinguish patients with delirium from patients without delirium very well. however, these findings need to be validated in an unselected population. the primary objective of this validation study is to investigate the sensitivity, specificity, and predictive values of the eeg-based delirium monitor (including three electrodes and a reference electrode) compared to delirium quantification in frail elderly patients after surgery. in an international multicenter study, 154 frail elderly patients will be included who will undergo elective surgery and are expected to remain admitted for at least two postoperative days. patients are excluded if communication is not possible or admitted for neurological surgery. a five minute eeg registration with the delirium monitor with four electrodes will be performed prior surgery and three consecutive days after surgery or until discharge. within one hour of the eeg recording, the delirium assessment will be performed and recorded on video, which will be evaluated by delirium experts. the relative delta power (calculated from one minute of artifact-free eeg segment) will be compared with the conclusion of the delirium experts.


Eligibility criteria:
inclusion criteria: * 60 years and older * frail * undergoing elective surgery * expected to remain admitted for at least 2 postoperative days exclusion criteria: * no communication possible due to a language barrier or deafness * admission for neurological surgery * participation in this study during a previous hospital admission * practical or logistical reasons hampering the use of the delirium monitor, such as technical failure of the monitor * isolation because of known carrier ship of a resistant bacterium

Keywords: validation studies eeg
icg- livertest versus new biomarkers as prognostic markers in critically ill icg- livertest versus new biomarkers as prognostic markers in critically ill

Conditions: Critically Ill Patients

Summary: icg- leberfunktionstest versus "neue" biomarker als prognostischer marker bei intensivmedizischen patienten


Eligibility criteria:
inclusion criteria: gruppe 1: * intensiv-patienten mit verbrennungen \> 10% der körperoberfläche * alter \> 18 gruppe 2: * intensivpatienten nach grossen chirurgischen eingriffen * alter \> 18 gruppe 3: * polytraumatisierte, intensivpflichtige patienten * alter \> 18 exclusion criteria: • alter \< 18 * schwangerschaft * einschluss in eine andere studie * moribunde patienten * patienten, die kein deutsch verstehen * jodunverträglichkeit
sofosbuvir plus ribavirin, or ledipasvir/sofosbuvir in adults with hcv infection and renal insufficiency

Conditions: HCV Infection

Summary: the primary objectives of this study are to evaluate the safety and efficacy of sofosbuvir (sof) plus ribavirin (rbv) for 24 weeks and ledipasvir/sofosbuvir (ldv/sof) for 12 weeks, and to evaluate the steady state pharmacokinetics (pk) of sof and its metabolites and ldv in participants with genotype (gt) 1, 3, or 4 hepatitis c virus (hcv) infection who have chronic renal insufficiency (impaired kidney function).


Eligibility criteria:
key inclusion criteria: * cohorts 1 and 2: chronic genotype 1 or 3 hcv infection * cohort 3: chronic genotype 1 or 4 hcv infection * hcv rna ≥ 10\^4 iu/ml at screening * screening labs within defined thresholds * cirrhosis determination at screening key exclusion criteria: * females who are pregnant or nursing or males who have a pregnant partner * prior null response to pegylated interferon (peg-ifn)+rbv therapy (cohorts 1 and 2) or for individuals with cirrhosis, prior treatment failure with ifn-based therapy not resulting from treatment intolerance (cohort 3) * current of prior history of hepatic decompensation * infection with hepatitis b virus (hbv) or hiv * history of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with individual's treatment and/or adherence to the protocol note: other protocol defined inclusion/exclusion criteria may apply.
an extension study of donidalorsen (ionis-pkk-lrx) in participants with hereditary angioedema

Conditions: Hereditary Angioedema

Summary: the purpose of this study is to evaluate the safety and efficacy of extended dosing of donidalorsen administered subcutaneously (sc), with alternative dosing and/or dose frequency with donidalorsen in participants with hereditary angioedema (hae).

this is an open-label extension study of donidalorsen in up to 24 participants with hae. the length of participation in the study is approximately 68 weeks, which includes an up to 4-week qualification period, a 52-week treatment period, and a 12-week post-treatment period. following the week 53 treatment period visit, participants will receive donidalorsen in an extended treatment period for up to an additional 156 weeks. participants taking part in the extended treatment period will enter the 12-week post-treatment period after completion of, or early termination from, the extended treatment period. this study was extended to allow participants to receive donidalorsen for an additional 156 weeks following the initial 53-week treatment period.

Eligibility criteria:
inclusion criteria: 1. satisfactory completion of isis 721744-cs2 (index study) through week 17 with an acceptable safety and tolerability profile, per sponsor and investigator judgement 2. able and willing to participate in a 64-week study 3. females must be non-pregnant, non-lactating and either surgically sterile or post-menopausal 4. males must be surgically sterile or abstinent\* or if engaged in sexual relations with a female of child-bearing potential, participant is utilizing an acceptable contraceptive method 5. participants must have access to, and the ability to use, ≥ 1 acute medication(s) (e.g., plasma-derived or recombinant c1- inhibitor (c1-inh) concentrate or a bradykinin-2 \[bk-2\] antagonist) to treat angioedema attacks exclusion criteria: 1. have any new condition or worsening of an existing condition or change or anticipated change in medication, which in the opinion of the investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study

Keywords: hereditary angioedema hae
imaging 61cuatsm uptake in atherosclerotic plaque using pet-ct

Conditions: Carotid Atherosclerosis

Summary: the build up of plaque in the wall of the artery supplying blood to the brain poses a risk of stroke when the plaques become unstable and fragile. it is important to determine which patients are most at risk so that surgery can be performed. there is evidence that the risk is greatest when these plaques become oxygen deficient (hypoxic). the investigators wish to use pet imaging to identify hypoxic plaque, to help decide whether and when to perform surgery. the investigators have developed radiotracers (imaging agents) for this purpose, and this study is to determine whether they will work in patients.


Eligibility criteria:
inclusion criteria: * male/female patients who are 55yrs or older and for whom carotid endarterectomy is clinically indicated and a decision has been made to perform a carotid endarterectomy. * normal liver and adequate renal function. assessed by measuring egfr (\>50ml/min) and creatinine (\<130μmol/l) * life expectancy \> 12 weeks * patients should be able to tolerate head/neck mask as well as lying in the pet-ct scanner exclusion criteria: * abnormal liver and renal function (egfr \ 130μmol/l) * patient unwilling to provide written informed consent
collective accuryn physiologic signals and signatures

Conditions: Critical Illness; Acute Kidney Injury; Sepsis; Septic Shock; Abdominal Compartment Syndrome

Summary: the capss study is a retrospective and prospective, multi-center, single-arm post-market data collection study with an fda cleared device. physiologic data measurements will be collected from enrolled subjects using electronic health records and data streams via the accuryn monitoring system. analysis of these data has the potential to be able to acutely guide resuscitation and monitor trends for emerging critical conditions.

the primary objective of the capss study is to track and analyze changes in physiologic data streams to identify clinical signatures that may enable earlier diagnosis of, and effective intervention in, critical conditions.

Eligibility criteria:
inclusion criteria: 1. received accuryn monitoring system during hospital stay. 2. diagnosed with or developed one or more of the targeted conditions while connected to the accuryn monitoring system. exclusion criteria: 1. in the opinion of the investigator, the patient is unsuitable for the study.
buprenorphine sublingual spray for the treatment of moderate to severe pain

Conditions: Post-operative Pain

Summary: this is a phase 3, multicenter, randomized, double-blind, multiple-dose, parallel-group, placebo-controlled study to evaluate the safety and efficacy of up to 3 dosing regimens of buprenorphine sublingual (under the tongue) spray and/or matching placebo in participants with moderate to severe postoperative pain after bunionectomy. the study will comprise 4 periods: the screening period, the surgical period, the treatment period, and the follow-up period. participants will be admitted to the study site on the morning of the scheduled surgery, will remain at the study site until postoperative day 3 (a total of 3 nights at the study site), and will return for the follow-up visit 5 to 9 days after surgery.


Eligibility criteria:
inclusion criteria: * meets protocol-specified criteria for qualification and contraception * is able to speak and understand the language in which the study is being conducted, is able to understand the procedures and study requirements and has voluntarily signed and dated an informed consent form approved by the institutional review board before the conduct of any study procedure * is willing and able to comply with study requirements (including diet, alcohol, and smoking restrictions), complete the pain evaluations, remain at the study site for three days, and return for follow up between 7 and 9 days after surgery. exclusion criteria: * history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters * signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1. the safety or well-being of the participant or study staff 2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding) 3. the analysis of results

Keywords: bunionectomy
coenzyme q10 supplementation in children with idiopathic dilated cardiomyopathy

Conditions: Dilated Cardiomyopathy

Summary: this study aims to determine the effect of coenzyme q10 supplementation on conventional therapy of children with heart failure due to idiopathic dilated cardiomyopathy.

this study aims to determine the effect of coenzyme q10 supplementation on conventional therapy of children with heart failure due to idiopathic dilated cardiomyopathy. in a prospective, randomized, double-blinded, placebo-controlled trial, patients younger than 18 years with idiopathic dilated cardiomyopathy randomizes to receive either coenzyme q10 or placebo. echocardiographic systolic and diastolic function parameters are determined for every patient at baseline, after three,six and nine months of supplementation.

Eligibility criteria:
inclusion criteria: * known cases of idiopathic dilated cardiomyopathy (idc) * those patients in whom heart failure medications were stable for at least 1 month * more than 6 months aged exclusion criteria: * recent modification in medications * hemodynamic instability * congenital heart disease * metabolic heart disease * cardiac dysfunction resulting from abnormalities in other organs and those with an acquired cardiomyopathy

Keywords: coenzyme o10 children idiopathic dilated cardiomyopathy
effects of tysabri (bg00002) over 12 months on ms related fatigue in participants with rrms

Conditions: Relapsing-Remitting Multiple Sclerosis; Fatigue

Summary: the primary objective of this trial is to observe the multiple sclerosis (ms) related fatigue during treatment with tysabri as measured by changes in the fatigue scale for motor and cognitive functions (fmsc) over the course of 12 months. the secondary objectives are: to investigate changes in fatigue, capacity for work, health related quality of life (hrqol), sleepiness, cognitive impairment, physically activity induced exhaustion, speed of walking, status of ms disease progression and amount of walking at different times points after initiation of tysabri treatment in participants diagnosed with relapsing-remitting multiple sclerosis (rrms). changes in fatigue are measured at 3, 6 and 9 months, whereas changes in capacity for work, hrqol, sleepiness, cognitive impairment, physical activity induced exhaustion, speed of walking, status of ms disease progression and amount of walking are measured at 6 and 12 months. to investigate correlation between fatigue and cognitive impairment, depression and physically activity induced exhaustion and status of ms disease progression in participants at baseline, 6 and 12 month of treatment with tysabri and to document any changes in fatigue related medication.


Eligibility criteria:
key inclusion criteria: * tysabri prescribed according to national guidelines but not yet started treatment * signed informed consent form * fsmc sum score above \> 43 at baseline (mild fatigue) key exclusion criteria: * fsmc sum score below 43 at baseline * history of treatment with tysabri * edss \> 6 at baseline * amphetamine as medication * major depression note: other protocol defined inclusion/exclusion criteria may apply