Kornimate/medical-research-clean huggingface dataset:
post-marketing surveillance of evrenzo® tablets (roxadustat) in patients with renal anemia

Conditions: Renal Anemia

Summary: the purpose of this study is to assess the safety and efficacy, including the incidence of thromboembolism, in renal anemia patients treated with roxadustat (evrenzo® tablets) in actual clinical settings.

this is a post-marketing long-term specified drug use-result survey study required for products in japan. in the survey, patient registration and data collection will be conducted using post-marketing survey data collection system, postmanet via the internet. patients who are eligible for the survey will be registered within 14 days after the start of treatment with roxadustat (including the start day of treatment). for all registered patients (including discontinuations/dropouts), the investigator will enter the necessary information in the case report form (crf) and send it immediately after the end of the specified observation period for each patient.

Eligibility criteria:
inclusion criteria: * renal anemia patients who are naïve to roxadustat. exclusion criteria: * not applicable

Keywords: asp1517 evrenzo roxadustat
a study of the effectiveness and safety of lidoderm® as add-on treatment in patients with postherpetic neuralgia, diabetic neuropathy, or low back pain

Conditions: Postherpetic Neuralgia; Diabetic Neuropathy; Low Back Pain

Summary: patients with a diagnosis of postherpetic neuralgia (phn), diabetic neuropathy (dn), or low back pain (lbp) who were currently receiving an analgesic regimen that contained gabapentin participated in a phase iv clinical trial to assess the effectiveness of lidoderm® administered once daily (q24h) after 14 day in the treatment of phn, dn, or lbp in patients who had a partial response to a regimen containing gabapentin.


Eligibility criteria:
inclusion criteria: * were currently receiving an analgesic regimen that contained gabapentin * had been on a stable dose of gabapentin for at least 14 days (same dose ±10% for 14 days) * had a partial response to a gabapentin-containing analgesic regimen defined as an average daily pain intensity score of \>4 on a ) to 10 scale, with 0 being no pain and 10 being pain as bas as the patients have ever imagined (question 5 of the brief pain inventory \[bpi\] within 24 hours prior to the screening visit * for diabetic patients, had a hemoglobin a1c level \<0.13 (normal range, 0.047-0.064) exclusion criteria: * had a neurological condition other than that associated with their pain diagnosis that, in the opinion of the investigator, would have interfered with their ability to participate in the study * had received an epidural steroid/local anesthetic injection within 14 days prior to study entry * had received trigger point injections within 14 days prior to study entry * had received botox injections within 3 months prior to study entry * were taking a lidocaine-containing product that could not be discontinued while receiving lidoderm * were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)
trial of oral melatonin in elevated blood pressure

Conditions: Elevated Blood Pressure

Summary: since, lowering blood pressure (bp) in elevated blood pressure individuals represents an excellent opportunity to for primary prevention of hypertension (htn). therefore, it is planned to use a safe treatment option - oral melatonin supplementation - associated with lifestyle interventions according to the american college of cardiology/american heart association (acc/aha) 2013 guideline in elevated blood pressure individuals to mitigate systolic and diastolic bp and ultimately, to prevent the development of htn. hypothesis: melatonin therapy can lower the systolic and diastolic bp of elevated blood pressure individuals melatonin can attenuate levels of circulatory biomarkers of hs- crp, cholesterol, ldl-c and triglyceride

study design: randomized controlled trial (rct) study population: elevated blood pressure individuals who present themselves at the outpatient clinics of tehran heart centre(thc) , seeking blood pressure treatment and who have a systolic blood pressure of 120-129 mmhg or a diastolic blood pressure of =80 mmhg. treatment groups: melatonin 3 mg versus placebo sample size: 160 per group ( 320 overall) treatment allocation: after completing informed consent and prior to randomization, all participants undergo complete physical examination and laboratory test. baseline levels of inflammatory biomarkers and pregnancy test (for women in reproductive age) will be performed. sleep quality, actual sleep time, and sleep latency will be recorded. treatment plan: three weeks melatonin 3 mg or placebo one hour before bedtime has been planned. all of the melatonin and placebo capsules will be supplied from a single hospital pharmacy and free of charge to the participants. melatonin and placebo capsules will be identical. participants will receive a three weeks supply at the assignment time. besides, all participants will receive a careful plan of adherence to a heart-healthy diet, regular exercise, instruction for avoidance of tobacco use and maintenance of a healthy body mass index (bmi) according to 2013acc/ aha guideline. follow up: three weeks

Eligibility criteria:
inclusion criteria: * individuals with systolic blood pressure120-129 and/or diastolic blood pressure =80mmhg * negative pregnancy test for women at productive age * baseline melatonin and biomarkers level and complete liver function tests within normal range exclusion criteria: * previous history of hypersensitivity of melatonin * past history of using antihypertensive treatment * past medical history of hypertension, cardiovascular diseases, (i.e. coronary artery disease), and diabetes mellitus, epilepsy and other physician documented diseases * use of beta-blockers, sleep aids, warfarin, flaxseed, soy and supplements

Keywords: melatonin inflammatory biomarkers
community intervention to improve depressive symptoms among older adults (vidactiva)

Conditions: Depression, Anxiety

Summary: the goal of this pilot trial is to test how feasible is to conduct a large clinical trial that evaluate both implementation and effectiveness outcomes of a community-based interventions for older adults with depression in low-resource urban settings from lima, peru. the main questions: is the way we are planning the study, including those who are taking part and what they will do, good for a large study? is the interventional package we are developing good the way it is, and can it be done the way we planned it?

participants who join will be split into two groups: one group will get the interventional program, and the other group will get standard care. in the interventional group, community health workers will meet with participants eight times to do activities and talk about how they feel. the standard group will have two visits where they will learn things about mental health. the results of the study will help the researchers understand whether they can test the program in larger study. additionally, see whether those participants in the interventional group feel better than those who are in the standard group. sample size: this is a pilot trial. no sample size calculations are needed because the objective is not to evaluate the effect of the intervention, but rather the feasibility of conducting a large-scale clinical trial. it is expected to enroll 64 participants (32 control group vs 32 intervention group). this number is based on previous formative study and training of community health workers. researchers will collect basic information to assess feasibility for a larger trial, including: * number of potential participants screened per month; * number of participants enroled per month; * average time from enrolment to randomisation. * average time to reach enrolment goal * proportion of eligible participants who enrol * proportion of people who maintain the study in both groups. * reasons for abandoning the study. * visit durations

Eligibility criteria:
inclusion criteria: * having depressive symptoms (score equal to or greater than 6 on the patient health questionnaire - phq 9). * capacity to give consent. * current residence in villa el salvador, lima, peru. exclusion criteria: * previous diagnosis of bipolar disorder * history of substance abuse * history of dissociative disorder, psychosis or dementia, or moderate memory and/or cognition problems.

Keywords: depression aged problem-solving
pedometer intervention and health effects for sedentary colorectal cancer patients during adjuvant chemotherapy

Conditions: Colorectal Cancer

Summary: colorectal cancer is one of the most common cancers in denmark, annually 4,200 men and women are diagnosed and approx. 2000 patients die of their colorectal cancer. as with other cancers, the risk of colorectal cancer increases with age, and the median age at diagnosis is 71 years. improved treatment has increased the number of survivors with an expected 5-year survival rate of 50-60%. characteristic of this group of patients is that at the time of diagnosis they often live with comorbidities and have limited leisure time physical activity. there is evidence that rehabilitation in the form of physical exercise for cancer patients after their initial treatment has a positive effect on a number of physical and psychological parameter such as health-related quality of life, physical capacity and physical function, fatigue, anxiety and depression. however, the most frequently studied diagnosis group is women with breast cancer. until now only few studies have evaluated the effects of physical activity among colorectal cancer patients receiving chemotherapy the purpose of this study is: to examine the effect of two different training initiatives - 12 weeks progressive, high-intensity training versus low intensity exercise intervention - on physical, emotional and social habitus, in sedentary patients with colorectal cancer during adjuvant chemotherapy. the hypothesis of the study are: 1. that both interventions will show a positive association between increased physical capacity (measured by aerobic capacity vo2-peak / peak oxygen uptake) and improved physical function, reduced fatigue and anxiety in the included sedentary colorectal cancer patients undergoing adjuvant chemotherapy. participants: patients undergoing adjuvant chemotherapy for colorectal cancer who have self-reported physical activity level below the national recommended levels (less than 150 min/week of moderate leisure time physical activity, and exercises at least 20 minutes of strenuous physical activity twice a week). benefits and risks of participating: possible benefits of the interventions: to reduce treatment related symptoms and side-effects, increase vitality and well-being and promote lifestyle changes among sedentary colorectal cancer patients receiving adjuvant chemotherapy. at participation in the interventions minor sports injuries may occur.


Eligibility criteria:
inclusion criteria: * diagnosed with colorectal cancer in adjuvant chemotherapy * age 18+ years * who performance status of 0 or 1 * undergone surgery at least 6 weeks ago * do not meet criteria for recommended physical activity level of 150 min / week of moderate leisure time physical activity, and exercises at least 20 minutes of strenuous physical activity twice a week. exclusion criteria: * myocardial infarction within the past six months * symptomatic heart failure * known angina pectoris * contraindication for moderate to strenuous physical activity

Keywords: undergoing chemotherapy exercise intervention health counselling symptom management
effects of a 12-week strength training program in men with myotonic dystrophy type 1

Conditions: Myotonic Dystrophy 1

Summary: eleven men with myotonic dystrophy type 1 (dm1) underwent a 12-week lower-limb strength training program. the training program consisted of 3 series of 6 to 8 maximal repetitions of 5 different exercises: leg extension, leg press, hip abduction, squat and plantar flexion. training sessions were closely supervised and took place twice a week. it is hypothesised that the training program will induce muscular hypertrophy despite the genetic defect. the training program should also have positive effects on function. the participants were evaluated at baseline, week 6, week 12, month 6 and month 9 to see the effects of the training program and if these effects are maintained over time.


Eligibility criteria:
inclusion criteria: * dm1 diagnosis must be confirmed by genetic analysis; * male gender, aged between 30 and 65 years old; * be able to walk without assistance; * consent of the neurologist must be given to participate in this study; * must reside in the saguenay-lac-st-jean region; * subjects must be able to give their consent freely and voluntarily. exclusion criteria: * patients with any other form of muscular dystrophy are excluded; * any contraindication for strenuous exercise or muscle biopsy.
a study to evaluate solrikitug in participants with copd (zion)

Conditions: COPD

Summary: a randomized, double-blind, placebo-controlled, multiple dose-ranging study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of solrikitug in participants with chronic obstructive pulmonary disease (copd).

this is a 12-week randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, pk, immunogenicity, and pharmacodynamics of 2 dose levels of solrikitug versus placebo on top of standard of care in participants with copd. approximately 171 eligible participants with copd will be randomized at approximately 60-90 sites. participants will receive solrikitug, or placebo, administered via subcutaneous injection at the study site, over a 12-week treatment period. the study also includes a post-treatment follow-up period of 16 weeks.

Eligibility criteria:
inclusion criteria: * at least 40 years of age and no older than 75 years. * documented diagnosis of copd for at least 12 months prior to screening, defined by the gold guidelines (2023), and elevated blood eosinophils at screening. * at screening fev1/fvc ratio must be \<0.70, and post-bronchodilator fev1 must be ≥40% to \<80% predicted normal value calculated using global lung function initiative (gli) reference equations (cooper et al 2017). * symptomatic (copd assessment test \[cat\] score ≥10) at screening visit 1. * participants must be on 2 or more inhaled maintenance medications for management of their copd, for at least 3 months prior to screening. exclusion criteria: * female participant who is pregnant or breastfeeding. * participant has a known hypersensitivity to any component of the formulation of solrikitug, including any of the excipients, or a history of anaphylactic reaction to any therapeutic monoclonal antibody. * participant has history or evidence of any clinically significant cardiovascular, hematologic, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy, or any other condition that in the opinion of the investigator or medical monitor might obfuscate the study data. * any other pulmonary disease than copd that in the opinion of the investigator, the severity of the disorder would impact the conduct of the study. * undergone major lung surgery, within 1 year of screening visit 1. * participant has a lower respiratory tract infection that required antibiotics within 6 weeks prior to screening.
treatment management and factors affecting mortality in retroperitoneal hemorrhage due to cardiac catheterization; single center experience

Conditions: Treatment Procedure; Mortality

Summary: bleeding complications after cardiac catheterization have been reviewed previously, but there are very few studies on retroperitoneal hematoma and appropriate treatment of patients is not well defined. for this reason, the investigators aimed to analyze the clinical manifestations of retroperitoneal hematomas in a single center using a case-control study design, to analyze the treatment procedure determinants and consequently to provide an updated and usable treatment algorithm.


Eligibility criteria:
inclusion criteria: * retroperitoneal hematoma following cardiac catheterization exclusion criteria: * patients with retroperitoneal hematomas other than cardiac catheterization and patients with missing file records.
miniaturized extracorporeal circulation study

Conditions: Coronary Artery Disease

Summary: rationale: contemporary coronary artery bypass grafting (cabg) continues to be associated with a significant risk of postoperative bleeding. utilization of miniaturized extracorporeal circulation (miecc) significantly reduces the risk of postoperative bleeding but the underlying mechanisms are poorly understood. primary objective: to assess the impact of miecc compared to conventional extracorporeal circulation (cecc) on thrombin generation as indicator of the overall haemostatic capacity after cabg. secondary objectives to evaluate the impact of miecc versus cecc on blood loss and transfusion requirement, coagulation and fbrinolysis, inflammatory response, haemodilution and haemolysis, endorgan protection, seasibility and safety study design: single-center, double-blind, parallel-group randomized controlled trial study population: 60 patients undergoing non-emergent primary isolated cabg with ecc randomized 1:1 to receive either miecc or cecc

blood samples will be obtained at the following time points: * t0; preoperative after induction of anaesthesia (after insertion of central venous line) * t1; after weaning of the ecc prior to protaminization * t2; 10 minutes after full protaminization * t3; six hours after the end of the ecc * t4; 1. postoperative day (16-20 hours following end of surgery)

Eligibility criteria:
inclusion criteria: * non-emergent cabg with ecc * current use of low-dose acetylsalicylic acid * agreement of eligibility by the multidisciplinary heart team exclusion criteria: * inability to give informed consent * emergent treatment required (\< 24 hours) * concomitant cardiac surgery * previous cardiac surgery * severely reduced kidney function (egfr \< 30ml/min/1.73m2 or on dialysis) * severely reduced ejection fraction (ef \< 45%) * diagnosis of bleeding disorders * non-aspirin antiplatelet drugs stopped \< 5 days preoperatively (clopidogrel, prasugrel, ticagrelor, ticlopidine) * current use of systemic glucocorticoid therapy * current use of vitamin k antagonists or new oral non-vitamin k anticoagulants * platelet count \> 450 or \<100 x 109/l prior to surgery * pregnant women or women of child bearing potential without negative pregnancy test * active participant in any other intervention trial

Keywords: coronary artery bypass grafting miniaturized extracorporeal circulation thrombin generation
intermittent oro-esophageal tube on rehabilitation therapy compliance for stroke

Conditions: Stroke

Summary: the aim of this clinical trial is to compare rehabilitation therapy compliance of ischemic stroke patients who receive enteral nutrition support through either intermittent oro-esophageal tube or nasogastric tube. patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. the observation group will receive enteral nutrition support through intermittent oro-esophageal tube, while the control group will receive it through nasogastric tube. researchers will then compare rehabilitation therapy compliance of the two groups.

the study will last 15 days for each participant. the aim of this clinical trial is to compare rehabilitation therapy compliance of ischemic stroke patients who receive enteral nutrition support through either intermittent oro-esophageal tube or nasogastric tube. patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. the observation group will receive enteral nutrition support through intermittent oro-esophageal tube, while the control group will receive it through nasogastric tube. researchers will then compare rehabilitation therapy compliance of the two groups.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * meeting the diagnostic criteria of stroke; * any degree of dysphagia at admission; * steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment. * transferred out within three weeks of hospitalization in the neurology department. exclusion criteria: * complicated with other neurological diseases; * damaged mucosa or incomplete structure in nasopharynx; * tracheostomy tube plugged; * unfeasible to the support of parenteral nutrition; * simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
efficacy of dexmedetomidine for postoperative analgesia in infantile cataract surgery

Conditions: Postoperative Pain; Postoperative Vomiting

Summary: the purpose of the present study was to evaluate the efficacy and safety of subtenon block (sb)anesthesia with dexmedetomidine in combination with bupivacaine versus intravenous dexmedetomidine for postoperative analgesia and emesis control in infants undergoing cataract surgery.

in this prospective, randomized, controlled, double blind trial eighty asa physical status grade i and ii infants (1-12month) undergoing elective cataract surgery in one eye under general anesthesia were studied. infants were randomly allocated to one of the two groups: subtenon block group (sb) with dexmedetomidine (n =40) or intravenous dexmedetomidine group (iv) (n =40). after securing the airway, infants in group (sb) received sb block with 0.05 ml/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture, whereas infants in group (iv) received 1µ/kg iv dexmedetomidine after induction of anesthesia. surgery started after 5 min of study drug administration. postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics was the primary outcome. cries pain scale score , vomiting scale score during4-h study period, incidence of oculocardiac reflex and any surgical difficulty were the secondary outcomes.

Eligibility criteria:
inclusion criteria: 1. asa physical status grade i and ii infants (1-12month). 2. undergoing elective cataract surgery in one eye under general anesthesia. exclusion criteria: 1. infection of the orbit, 2. increased intraocular pressure(iop), 3. history of allergy to local anesthetics, 4. history of previous eye surgery, 5. cardiovascular or clotting disorders, 6. full stomach,inner ear disorders or other conditions predisposing to vomiting 7. airway abnormalities 8. compromised sclera.

Keywords: dexmedetomidine subtenon anesthesia postoperative pain pov