Kornimate/medical-research-clean huggingface dataset:
a post marketing evaluation of the effectiveness of flumist risk minimization plan in children

Conditions: Asthma; Wheezing; Immunosuppression

Summary: this is a retrospective cohort study of children included in a large medical insurance claims database.

* to evaluate the rate of flumist administration compared to other influenza vaccine use in the following pediatric populations: * children younger than 24 months of age * children 24-59 months of age with a claim associated with a diagnosis of asthma * children 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing * children 24-59 months of age with immunosuppression * to describe, in children in the above populations who receive flumist, the type and number of emergency room visits or hospitalizations associated with an insurance claim within 42 days of receiving flumist * to explore the rationale for flumist immunization of pediatric populations that are excluded from recommended usage by characterizing the use in these populations

Eligibility criteria:
* children less than 24 months of age during august through january/february. * children \<24 to 59 months of age during august through january/february, with: * two outpatient claims for asthma, or * one inpatient/emergency room claim for asthma, or * one outpatient claim for asthma and at least one saba prescription during a defined 12-month period. * children \<24 to 59 months of age during august through january/february, without any claims associated with a diagnosis of asthma, but with at least one dispensing for saba, as indicated by pharmacy claims during a defined 12-month period. * children 24 to 59 months of age during august to january/february with evidence of immunosuppression prior to the date of influenza vaccination based on available medical and pharmacy claims.
efficacy of dexamethasone to improve clinical outcomes in coronary artery bypass patients

Conditions: Coronary Artery Disease; Inflammatory Response

Summary: this is a single-center, double-blind, randomized controlled clinical trial comparing four groups: placebo conventional coronary artery bypass graft (ccabg) group, dexamethasone ccabg group, placebo off-pump coronary artery bypass (opcab) group, and dexamethasone opcab group. the primary outcomes of this study is comprised of presence of arrhythmia, major adverse cardiac events (mace), myocardial infarction, stroke, renal failure, respiratory failure, inflammation, and death. these primary outcomes were assessed during the surgery, 18 hours post surgery, every day during the hospital stay, 14 days and 30 days post surgery.

a single center randomized controlled clinical trial was conducted at harapan kita national cardiovascular center, jakarta, indonesia, as the tertiary cardiovascular referral hospital. the rct was conducted from july 1st, 2018 to march 31st, 2019 (current status: completed). this study assessed the efficacy of intraoperative high dose dexamethasone administration (1 mg/kg bw, maximum dose 100 mg) in reducing inflammatory response and improving clinical outcome in patients undergoing coronary artery bypass surgery. the study groups consist of placebo ccabg, dexamethasone ccabg, placebo opcab, and dexamethasone opcab. the subjects were adults indicated to undergo elective coronary artery bypass surgery with no evidence of prior inflammation nor allergic reaction to dexamethasone. both the patients and the principal investigators were blinded for the treatment-control allocation. the patients were purposively selected and were randomly assigned to one of the arms with block randomization. the primary outcomes of this study is comprised of presence of arrhythmia, major adverse cardiac events (mace), myocardial infarction, stroke, renal failure, respiratory failure, inflammation, and death. these primary outcomes were assessed during the surgery, 18 hours post surgery, every day during the hospital stay, 14 days and 30 days post surgery. the minimum sample size required for this study was 100 subjects (25 each group).

Eligibility criteria:
inclusion criteria: * coronary artery disease patients indicated for elective coronary artery bypass surgery * patients aged \>18 years old * patients who agreed to participate in this study exclusion criteria: * patients with preoperative systemic inflammation evidenced by high axillary temperature (≥38◦c) and high leukocyte count (≥15.000 ul) * patients with chronic arrhythmia * patients who are indicated to undergo other procedures than coronary artery bypass (i.e. valvular repair, septal repair) * patients with history of severe organ dysfunction (class iv congestive heart failure, renal failure, respiratory arrest, and stroke with sequelae) * patients with history of cardiac surgery * patients who takes routine corticosteroids or immunomodulators * patients who are allergic to corticosteroids

Keywords: dexamethasone arrhythmia atrial fibrillation ventricular tachycardia ventricular fibrillation
neurocognitive dysfunction after anesthesia in patients with recent concussion

Conditions: Concussion, Brain

Summary: researchers are trying to determine if the impact of a concussion on the brain is affected by anesthesia and surgery.

all subjects will complete pre and post procedure assessments prior to undergoing a planned surgery/anesthetic standard of care.

Eligibility criteria:
inclusion criteria: * male or female \>16 years of age with a recent concussion (\<10 weeks) from planned procedure under anesthesia. exclusion criteria: * neurologic history including history of severe cognitive disease, disorder, or delay, attention disorder, moderate to severe tbi history, neurovascular order or trauma.
effectiveness of creatine on pain, fatigue, and muscle architectural variables in patients witg fibromyalgia.

Conditions: Fibromyalgia

Summary: creatine, a non-protein organic amino acid, is synthesized from arginine, glycine, and methionine. the use of creatine has been shown to be effective in healthy subjects, providing benefits primarily in terms of strength, which has been the main factor studied. in patients with various conditions, including pain, creatine supplementation has demonstrated a reduction in pain and even cognitive improvements. due to creatine's general improvement in muscular endurance and fatigue.

through this study, we aim to analyze whether creatine supplementation can be beneficial in reducing symptoms in patients with fibromyalgia. previous studies have demonstrated its benefits, and therefore, we want to evaluate if these benefits can manifest in a shorter time compared to previous studies in patients with fibromyalgia.

Eligibility criteria:
inclusion criteria: * diagnosed with fm * aged between 18 and 75 years * agree to participate and sign the informed consent exclusion criteria: * who do not have recent surgeries * patients with reduced mobility * adequate level of comprehension to be able to answer the questionnaires that will be provided in the study * if they are taking antihypertensive medications

Keywords: creatine pain
dexamethasone with super-hydration for prevention of postoperative nausea and vomiting

Conditions: Nausea and Vomiting, Postoperative

Summary: postoperative nausea and vomiting (ponv) are the most common and distressing side effects following laparoscopic cholecystectomy

in the operating room, standard monitors included electrocardiogram, noninvasive arterial blood pressure, arterial oxygen saturation, and end-tidal carbon dioxide were connected. all patients received standardized anesthetic technique. at the end of surgery, gastric contents were suctioned via an orogastric tube before extubation. atropine and neostigmine (1/2.5 mg) was given slowly i.v. to antagonize the residual neuromuscular block. then, the trachea was extubated. then, patients were transferred to the post-anesthesia care unit in a stable condition. patients were allowed to drink liquids as soon as requested.

Eligibility criteria:
inclusion criteria: american society of anesthesiologists (asa) physical status i or ii aged elective laparoscopic cholecystectomy exclusion criteria: steroids use within the last 3 days before surgery antiemetic use within the last 3 days before surgery opioids use within the last 3 days before surgery. patients with liver, cardiac or renal diseases patients with pregnancy patients with bmi ˃ 30kg/m2 patients with delayed wound healing open surgery

Keywords: dexamethasone super-hydration laparoscopic cholecystectomy nausea vomiting postoperative
long-term study of ige025 in moderate to severe bronchial asthma.

Conditions: Asthma

Summary: this study will evaluate the safety and efficacy of omalizumab up to 48 weeks in adult patients with moderate to severe bronchial asthma. this study is not enrolling patients in the united states


Eligibility criteria:
inclusion criteria: * allergic asthma patients * inadequately controlled patients exclusion criteria: * - history of severe anaphylactoid or anaphylactic reactions * previous treatment with omalizumab * history of cancer or cancer other protocol-defined exclusion criteria may apply.

Keywords: asthma, ige, omalizumab
economic burden of knee osteoarthritis in talavera de la reina health area.

Conditions: Knee Osteoarthritis

Summary: this is a descriptive retrospective study of individuals affected with knee osteoarthritis. the aim of this study is to describe the sociodemographic and clinical characteristics of individuals diagnosed with knee osteoarthritis within a specific health area, as well as to assess the economic impact of this condition on the healthcare system. to achieve this, medical records will be reviewed, and the following data will be collected: sociodemographic and clinical participant data. healthcare resource use. clinical burden. up to 400 subjects will be enrolled in the talavera de la reina health area (toledo, spain).

this is a multicenter, observational, retrospective study focusing on individuals diagnosed with knee osteoarthritis. this study will be conducted in the talavera de la reina health area (toledo, spain). participants will be identified through the codes assigned in the electronic database associated with knee osteoarthritis. data will be collected from the initial radiologic diagnostic moment to december 31, 2019. for each participant enrolled, data from medical records will be collected and entered onto an electronic case report form (redcap). the sociodemographic and clinical data related to the pathology will be collected, including age, weight, height, duration of the condition, and occupational activity. the following data will be considered as direct healthcare costs: the number of visits in primary and specialized care, diagnostic tests, surgical interventions, and emergencies at both health centers and hospitals. in addition, pharmacotherapy, rehabilitation number of sessions, and work absences (temporary and permanent) will be registered. for cost estimation, a prevalence-based approach and a bottom-up estimation will be employed in the monetary valuation of healthcare resources, utilizing official sources.

Eligibility criteria:
inclusion criteria: * patients ≥18 years old. * diagnosed with unilateral or bilateral knee osteoarthritis according to the clinical criteria of the american college of rheumatology. * radiographic imaging diagnosis based on the kellgren \& lawrence (k-l) classification. exclusion criteria: * no available x-ray. * pre-existing neurological diseases before the diagnostic date (stroke, parkinson's, multiple sclerosis, als). * connective tissue disorders (ehlers-danlos, marfan). secondary cause of osteoarthritis or severe osteoarthritis (acl tears, severe traumas, infections, or sepsis). * inflammatory arthropathy (any type of arthritis). * genetic disorders with a higher risk of developing arthropathies (down syndrome).

Keywords: knee osteoarthritis economic burden physical therapy retrospective observational
optimal exercise regimens for persons at increased risk

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia

Summary: to assess exercise training adherence and compliance over two years in subjects who were at relatively high risk for coronary artery disease. also, to test strategies for improving adherence and compliance and to assess the effect of exercise training.

background: regular physical exercise is associated with lower coronary heart disease mortality, favorably affects coronary risk factors, and increases cardiovascular functional capacity. fewer than one-third of americans engage in regular physical exercise and only 20 percent of men and 10 percent of women over age 45 do so. this is largely because effective strategies for increasing the exercise habit in a broadly-based segment of americans have not been developed. this study applied physiological and behavioral knowledge derived in numerous laboratories over the past 10-15 years to a clinical setting. design narrative: following stratification by gender and cigarette smoking status, subjects were randomized to one of four groups: home exercise of moderate intensity which was individually monitored; home exercise of high intensity which was individually monitored; exercise of high intensity which was group supervised; and a no program control group. the intervention program was conducted for one year followed by a one-year maintenance program. main outcome measures included treadmill exercise test performance, exercise participation rates, and heart disease risk factors. variables measured over two years included plasma lipids, lipoproteins, apoproteins, lipase activity, glucose and insulin, sex hormones, cardiovascular reactivity to psychological stress, cigarette smoking, nutrient intake, psychological status, and cardiovascular functional capacity.

Eligibility criteria:
sedentary men and women, ages 50 to 65. women were postmenopausal and not taking hormone replacement therapy. all subjects were free from, but at increased risk for, coronary heart disease.
study to evaluate the analgesic efficacy of 28 days' oral administration of azd2066 compared with placebo in patients with painful diabetic neuropathy

Conditions: Pain; Diabetic Neuropathy

Summary: the purpose of this study is to investigate if azd2066 can relieve the pain arising from painful diabetic neuropathy compared to placebo.


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures. * clinical diagnosis of painful diabetic neuropathy. * non-fertile females exclusion criteria: * other pain that may confound assessment of neuropathic pain. * ongoing significant peripheral arterial diseases, skin ulcers, or amputation in the lower extremities. * history of psychotic disorders among first degree relatives.

Keywords: pain diabetic neuropathy pdn analgesia efficacy
effectivity and safety of combination cream of salicylic acid, aqua posae filiformis, niacinamide, lipohydroxy acid, procerad and zinc pca

Conditions: Acne Vulgaris

Summary: this clinical study will compare the effectivity and safety of combination cream of salicylic acid, aqua posae filiformis, niacinamide, lipohydroxy acid, procerad, and zinc pca as adjuvant therapy for acne vulgaris patients. these combination cream will be tested by mild to moderate acne vulgaris patients. participants will be female patients aged 15-50 years old and divided into three groups. the control group (group 1) will use adapalene 0.1% cream only every night. group 2 will use adapalene 0.1% cream intermittently every two nights and the combination cream every morning. group 3 will use adapalene 0.1% cream every night and the combination cream every morning.

this study is an experimental study with a randomized controlled trial (rct) design on mild to moderate acne vulgaris patients who met the inclusion criteria. this study will be conducted in five dermatology and venereology education centers in indonesia located in jakarta (rumah sakit umum pusat nasional dr. cipto mangunkusumo), jakarta (rumah sakit pusat angkatan darat gatot soebroto), padang (rumah sakit umum pusat dr. m. djamil), surakarta (rumah sakit umum daerah dr. moewardi), and malang (rumah sakit umum daerah dr. saiful anwar). group 1 as control group, will receive adapalene 0.1% cream only every night. group 2 will receive adapalene 0.1% cream only intermittently every two nights, and the combination cream every morning. group 3 will use adapalene 0.1% cream every night and the combination cream every morning. all participants will be evaluated in day 28 and 56. therapy evaluation will be assessed based on the global acne severity scale (gea score), indonesia acne expert meeting (iaem score), level of seborrhoea, clinician erythema assessment scale (cea), facial skin analysis with janus skin facial analysis, and evaluation of the quality of life using cardiff acne disability index and acne-quality of life (acne-qol) specifically for participants aged older than 18 years old.

Eligibility criteria:
inclusion criteria: * female aged 15 - 50 years * mild and moderate acne vulgaris according to iaem and gea. * patients are willing to participate in the study until it is finished. exclusion criteria: * history of allergy to dermatocosmetic products. * undergoing other acne therapy, medication, or invasive action in the last month. * pregnant or breastfeeding patients

Keywords: combination cream aqua posae adjuvant therapy
retrospective evaluation of posterior direct restorations

Conditions: Dental Caries Class II

Summary: this retrospective study aims to evaluate the clinical performance of posterior multi-surface class ii amalgam (am) and resin composite (rc) restorations placed by dental students over a five-year period.

purpose: the aim of this retrospective study is to evaluate the clinical performance of posterior multi-surface class ii amalgam (am) and resin composite (rc) restorations placed by dental students over a five-year period. materials and methods: a total of 119 multi-surface class ii restorations (three or more surfaces) placed by third and fourth year students will be evaluated (am: n = 69 and rc: n = 50). restorations were assessed clinically according to the usphs criteria by two independent evaluators using mirrors and probes. data will be analyzed using chisquare, mann-whitney and wilcoxon tests at a 0.05 level of significance.

Eligibility criteria:
inclusion criteria: * presence of multi-surface (three or more surfaces) composite or amalgam restorations placed by dental students over a five-year period. exclusion criteria: * children * restorations performed before or after five years on the time of evaluation * restorations with fewer than 3 surfaces

Keywords: amalgam, dental composite resin
organ protection by remote ischemic preconditioning for surgical treatment of pediatric congenital heart disease

Conditions: Heart Ischemia; Cerebral Ischemia

Summary: cardiac surgery is associated with risk of perioperative inflammation and ischemia leading to cerebral and myocardial morbidity and mortality. ischemic preconditioning by repetitive ischemic episodes at an organ can reduce damage resulting from consecutive prolonged ischemia in that organ. remote ischemic preconditioning is defined as ischemic preconditioning by repetitive ischemic episodes of an organ remote from the organ to be protected, e.g. ischemic episodes of a limb can reduce ischemic damage of the heart. animal studies as well as human studies have shown that ischemic preconditioning can protect the heart from intraoperative ischemia. remote preconditioning by repetitive limb ischemia has been applied in humans in some studies.12-14 however, the published data is not yet sufficient to support evidence based recommendations for clinical practice. in particular, available data regarding the influence of remote preconditioning on inflammatory and ischemic damage of brain and heart in children following surgery of congenital heart disease are limited. hence, this prospective, controlled and randomized study was designed to perform remote ischemic preconditioning in children after induction of anesthesia for pediatric heart surgery and to investigate the effect on postoperative organ function in comparison to a control group.

arterial blood flow to the right leg of the patients is interrupted by inflating a cuff around the thigh up to a pressure of 15 mmhg above the systolic blood pressure for five minutes. thereafter the pressure is released for another five minutes and the procedure is repeated fourfold. cerebral and myocardial damage are examined by postoperative laboratory exams in comparison to preoperative baseline values. in addition to this, systemic immune response, renal function, duration of intensive care and time to discharge from hospital are compared between groups. mechanisms of remote preconditioning are investigated by analyzing gene expression in human heart tissue obtained during surgery and in leukocytes. the investigation is not associated with any known risks for the children.

Eligibility criteria:
inclusion criteria: * congenital heart surgery exclusion criteria: * hypoplastic left heart syndrome
effect of probiotic supplement on improvement of depressive symptoms in patients with substance-induced depressive disorder

Conditions: Depressive Disorder; Depressive Disorder, Major Depressive Disorder

Summary: this study investigates the potential of probiotics as a therapeutic intervention for substance-induced depressive disorder (sidd). the primary question the study aims to answer is: can a four-week course of probiotics improve depressive symptoms and alter immune markers in patients diagnosed with sidd, compared to a placebo? the study uses a double-blind, placebo-controlled, randomized clinical trial design with 40 participants to explore this question by measuring clinical outcomes using bdi and ham-a and immunological markers.


Eligibility criteria:
inclusion criteria: * males and females, aged between 18 and 70 years * diagnosis of substance-induced depressive disorder as per dsm-5 criteria * absence of significant internal diseases as per exclusion criteria exclusion criteria: * pregnant or lactating * patients who for any reason cannot comply with adequate follow-up