Kornimate/medical-research-clean huggingface dataset:
study of efficacy and long-term safety of mometasone furoate in combination with formoterol fumarate versus mometasone furoate in children (5 to 11 years of age) with persistent asthma (mk-0887a-087)

Conditions: Asthma

Summary: this study compares the 12-week efficacy and 24-week safety of mometasone furoate/formoterol fumarate (mf/f) 100/10 mcg and mometasone furate (mf) 100 mcg, both administered twice daily (bid) via metered-dose inhaler (mdi) in children aged 5 to 11 years with persistent asthma.


Eligibility criteria:
inclusion criteria: * has a diagnosis of asthma of ≥ 6-months duration according to the global initiative for asthma (gina) guidelines * has asthma that is adequately controlled on a stable dose of inhaled corticosteroid (ics) combined with long-acting beta-agonist (laba) ≥ 4 weeks * is able to demonstrate an fev1 \>60% and ≤90% predicted * is able to demonstrate an increase in absolute fev1 of at least 12% within 30 minutes after administration of albuterol/salbutamol. * is able to use an mdi (without spacer), use a peak flow meter, and perform spirometry correctly. * is willing (with consent of their parent(s)/guardian) to discontinue previously prescribed asthma medication, if there is no inherent harm in changing the participant's current asthma therapy. * has laboratory tests that are clinically acceptable to the investigator. exclusion criteria: * requires \>8 inhalations per day of albuterol (100 mcg per actuation), and/or \>2 nebulized treatments per day of 2.5 mg albuterol on any 2 consecutive days * has a clinical worsening of asthma that results in emergency room visit (for an asthma exacerbation), hospitalization due to asthma, or treatment with additional, excluded asthma medication (other than saba) between the screening and baseline visits. * is considered by the investigator to have unstable asthma at the end of the run-in period * has had \> 4 asthma exacerbations (defined as a worsening of asthma requiring systemic corticosteroid use and/or ≥ 24-hour stay in an emergency department, urgent care center, or hospital) within 1 year prior to visit 1 * has had a history of life-threatening asthma * has a clinically significant condition or situation, other than the condition being studied which may interfere with trial evaluations, participant safety, or optimal participation in the trial
methylene blue in early septic shock

Conditions: Septic Shock

Summary: septic shock is a subset of sepsis characterized by a decrease in vascular tone, which contributes to impaired regional blood flow distribution, and leads to organic failure. besides intravenous fluids and adequate antimicrobial therapy, patients with septic shock require vasopressor support, which can lead to many adverse effects, therefore, non-vasopressor agents that can improve hemodynamic status are needed. in this randomized controlled-study, the investigators will address the efficacy and safety of infusion with methylene blue in patients with septic shock.

unlike sepsis, septic shock mortality is not declining for the last decade, and is still around 40%. after restoring intravascular volume, many patients need vasopressor agents to maintain arterial blood pressure, which leads to improvement of perfusion at some vascular beds, however some organs may suffer from maldistribution of blood flow. these changes of regional blood flow may compromise oxygen delivery and perpetuate the inflammation and tissue damage associated with the state of shock. one of the main mechanisms of vasodilation after inflammatory insults, is the activation of the inducible isoform of nitric oxide synthase (inos), and the subsequent increase in the levels of nitric oxide, which even reduces the response to vasoconstrictor agents. methylene blue (mb) is a selective inhibitor of inos, which has been used successfully in patients with post-cardiopulmonary bypass associated vasoplegia, however, the evidence of the use of mb in septic shock patients is limited to case reports, observational and small studies. in this randomized controlled trial, the investigators will compare the efficacy and safety outcomes of repeated doses of mb in patients with septic shock.

Eligibility criteria:
inclusion criteria: * septic shock diagnosis, according to the sepsis-3 consensus. * prior adequate fluid resuscitation according to dynamic predictors of volume responsiveness. * more than 6 h and less than 24 h of norepinephrine requirement to maintain a mean arterial pressure ≥65 mmhg. exclusion criteria: * age \< 18 years. * pregnancy. * not expected to survive 48 hours. * presence or high suspicion of concurrent hemorrhagic, obstructive or hypovolemic shock. * personal or familiar history of glucose-6-phosphate dehydrogenase deficiency. * allergic to methylene blue, phenothiazines, or food dyes. * recent intake (4-weeks) of selective serotonin re-uptake inhibitors. * refusal of the patient or decision maker to enroll in the study.

Keywords: septic shock methylene blue norepinephrine
artemether/lumefantrine and vivax malaria

Conditions: Vivax Malaria

Summary: the cure rate of artemether/lumefantrine in the treatment of vivax malaria.


Eligibility criteria:
inclusion criteria: * patients with vivax malaria exclusion criteria: * severe malaria * pregnancy

Keywords: malaria vivax artemether/lumefantrine sudan
effects of deep breathing exercises two months after cardiac surgery

Conditions: CABG; Valve Surgery

Summary: hypothesis: deep breathing exercises performed during the first two months after cardiac surgery, will improve pulmonary function and patient-perceived quality of recovery. specific aim: to evaluate the effectiveness of breathing exercises performed with a mechanical device for positive expiratory pressure during the first two months after cardiac surgery compared to a control group performing no breathing exercises. design: a prospective, randomized, controlled two-center study.

contribution: the study will be taken place at two university hospitals in sweden. uppsala university hospital (phd, registered physical therapist (rpt)) margareta emtner and rpt charlotte urell) and örebro university hospital; (elisabeth westerdahl and rpt marcus jonsson). time planning: application to the research ethics committee april 2007. data collection 2007-2011. statistical analysis and manuscript writing 2011.

Eligibility criteria:
inclusion criteria: * a sample of 360 adults (\>18 years) patients undergoing cardiac surgery at the two university hospitals are invited to participate in the study. * type of cardiac surgery included will be coronary artery bypass graft surgery (cabg) with saphenous vein grafts and/or internal mammary artery graft, valve surgery or combinations of cabg and valve surgery. exclusion criteria: * patients who have an emergency operation, previous cardiac or lung surgery, renal dysfunction requiring dialysis or are unable to communicate in swedish will not be included. * patients who requires more than 24 hours respirator treatment, reintubation, reoperation, sternum instability/infection or develop a neurological, mental or haemodynamic complication that affects the patients' ability to collaborate, will be excluded.

Keywords: breathing exercises cardiac surgery lung function postoperative complication positive expiratory pressure
alveolar recruitment maneuver during pneumoperitoneum

Conditions: Oxygen Deficiency

Summary: alveolar recruitment maneuver had been reported of improving arterial oxygenation and pulmonary mechanics and reduce the pulmonary complications. investigator designed this study for comparision of incidence of pulmonary complications after applying alveolar recruitment maneuver during peumoperitoenum for laparoscopic surgery.

peumopritoneum might increase the pulmonary dead space and deteriorate the pulmonary mechanics. especially in the eldery, decreased pulmonary function might aggravate negative response to pneumoperitoneum. alveolar recruitment maneuver had been reported of improving arterial oxygenation and pulmonary mechanics. investigator designed this study for comparision of the incidences of pulmonary complications after applying alveolar recruitment maneuver or not during peumoperitoenum for laparoscopic surgery in the elderly patients.

Eligibility criteria:
inclusion criteria: * over 65 years, patients who undergoing elective laparoscopoic colorectal surgery for cancer under general anesthesia. asa pysical status i or ii exclusion criteria:uncontrolled cardiovascular disease, obstructive pulmonary disorder, acute or chronic inflammatory lesion in lung.
how well ethiopian parents assess and manage their children's postoperative pain: descriptive correlational study

Conditions: Parent; Pain; Ethiopia; Hospital

Summary: this study aims to evaluate the practice of mothers towards the evaluation and management of postoperative children's pain.according to this study, parents displayed low to moderate levels of knowledge adequacy towards the use of pain relief methods in relation to their children's postoperative pain and pain management, which indicates the need to provide parents with more information regarding their children's postoperative pain management.

introduction: acute postoperative pain in children is common. although mothers care for their children's pain in most cases, it has been noted that mothers have limited knowledge about pain assessment and management of children. objectives: this study aims to evaluate the practice of parents towards evaluating and managing postoperative children's pain. method: this descriptive correlational study was conducted among 102 parents with children aged between 2 and 12 undergoing elective surgical procedures. parental use of pain relief strategies (purps) and parental postoperative pain management (pppm) tools were used to collect data on the adequacy of knowledge of using different pain relief strategies and the skill of parental pain assessment, respectively. investigators used spearman's rank correlation coefficient to determine the relationships between pain scores given by parents and nurses. the statistical tests were performed at a 95% confidence interval and a 5% significance level.

Eligibility criteria:
inclusion criteria: * parents whose children are receiving elective surgical procedures * age between the ages of two and twelve in year * the legal parents' fluency in the local language in speaking, writing, and reading, * lack of a diagnosis of any visual, auditory, sensory, or other illness exclusion criteria: children with * asa classifications iii or iv, * significant developmental delays, * chronic illnesses * premature births, * underlying chronic pain conditions (e.g., diabetes) * a medical history of multiple painful experiences (e.g., malignancies)

Keywords: parents pain assessment management ethiopia wachemo university
muscular and functional performance in fais patients

Conditions: Femoroacetabular Impingement

Summary: following hip arthroscopy for femoroacetabular impingement syndrome (fais) decreased hip muscle strength for adduction, extension, flexion, and external rotation including impaired functional performance have been observed. however, no studies are lacking on more demanding muscular and functional parameters such as hip muscle rate of force development and reactive strength index. information on such muscular properties following hip arthroscopy for fais may help guide future planning of post-operative rehabilitation strategies. this is a cross-sectional study with an embedded prospective non-randomized study. the aim of the cross-sectional study is to investigate hip muscle function and functional performance in patients who have undergone hip arthroscopy for fais during the preceding 6-30 months. the aim of the prospective non-randomized study is to investigate the effect of a 12-week structured and supervised physiotherapy-led intervention aiming at improving hip muscular function on self-reported hip and groin function including hip muscle function and functional performance. forty-five subjects from the capital region with an age of 18-40, who have undergone a hip arthroscopy for fais during the last 6-30 months, will be included in the cross-sectional study. additionally, all included subjects will be offered to take part in the prospective non-randomized study consisting of 12 weeks of supervised and structured physiotherapy-led treatment. the below measures will be obtained at baseline, and at 12-weeks follow-up if subjects are included in the prospective study. all testing, and supervised physiotherapy-led treatment, will be performed at hvidovre hospital: 1. hip muscle function 2. single leg jump performance 3. self-reported hip and groin function 4. evaluation of return to sport 5. evaluation of satisfaction regarding usual-care post-operative rehabilitation


Eligibility criteria:
inclusion criteria: * male/female at the age of 18-40 years at the time of surgery * undergone hip arthroscopy for fais during the previous 6-30 months (surgical procedure: cam resection and labral surgery) * pre-operative cam morphology specified as an alpha angle ≥55° exclusion criteria: * pre-surgery joint space width \<3 mm * any of the following surgical procedures at any time: extra articular surgery of the hip joint (except capsular closure), microfracture, periacetabular osteotomy, and surgery of the ligamentum teres; previous hip arthroscopy in the same hip joint; previous hip pathology such as perthes' disease, slipped upper femoral epiphysis, hip dysplasia (lateral center edge angle \<25°), and/or avascular necrosis; any rheumatoid disease in the hip joint such as synovial chondromatosis.
effect of acute phenylcapsaicin intake on trained cross-training athletes

Conditions: Performance

Summary: the aim of this study is to investigate the effect of acute phenylcapsaicin intake during a cross-training session on perceived exertion, performance, and recovery in cross-training athletes.

capsaicin appears to enhance athletic performance by reducing perceived effort, increasing mechanical performance (e.g., total volume load), and decreasing muscle damage. given the close relationship between the metabolic and physiological responses of cross-training and supplementation with phenylcapsaicin (pc), it could be expected that consuming capsaicin during cross-training would have a favorable impact on perceived effort, recovery, and performance. 25 women and 24 men trained in crossfit consumed either phenylcapsaicin (pc) or a placebo during a crossfit class, which consisted of a 16-minute weightlifting segment and a 15-minute wod. both the rating of perceived exertion (rpe) and the perceived recovery status scale (rps) were administered at the beginning of the session and at the end of each segment of the crossfit session. doms was assessed using a visual analog scale at 24 and 48 hours after the crossfit session.

Eligibility criteria:
inclusion criteria: * age: 18-35 years. * body mass index: 18.5-30 kg/m2. * ability to understand the instructions, objectives, and study protocol. * minimum of 3 years of experience in crosstraining, with at least 6 hours of weekly training over the past 3 months. * resident on the island of tenerife. exclusion criteria: * history of a significant adverse cardiovascular event, renal insufficiency, cirrhosis, eating disorder, weight control surgical intervention, or type 2 diabetes mellitus. * any chronic pathology in which the intake of nutritional supplements, especially pungent components, is not recommended. * any condition that, in the investigator's judgment, would impair the ability to participate in the study or represent a personal risk to the participant. * use of medications that may affect the study results. * unstable body weight for 3 months prior to the start of the study (\> 4 kg loss or gain in weight). * active tobacco abuse or illicit drug use, or history of treatment for alcohol abuse. * on a special diet or prescribed for other reasons (e.g., celiac disease).

Keywords: phenylcapsaicin performance concurrent exercise nutrition recovery
influence of the noradrenergic system on the formation of intrusive memories

Conditions: Intrusive Memories

Summary: intrusive memories of traumatic events are core features of posttraumatic stress disorder (ptsd) but little is known about the neurobiological formation of intrusions. the aim of this study was to determine whether the activity of the noradrenergic system during an intrusion-inducing stressor influences subsequent intrusive memories.

the investigators conducted an experimental, double-blind, placebo-controlled study in 118 healthy women. prior to watching an established trauma film paradigm that induces short lasting intrusions, participants received a single dose of either 10 mg yohimbine, stimulating noradrenergic activity, or 0.15 mg clonidine, inhibiting noradrenergic activity, or placebo. the number of consecutive intrusions of the trauma film, the mean vividness of the intrusions and the mean degree of distress evoked by the intrusions were assessed during the following four days. salivary cortisol and alpha-amylase were collected at seven time points prior to, and after the trauma film.

Eligibility criteria:
inclusion criteria: * healthy participants * german on a native level exclusion criteria: * former or present dsm iv axis i disorders * physical illnesses * any medication intake (except oral contraceptive) * history of sexual abuse or rape * pregnancy or lactation period
correlation between somatic growth and number of erupted deciduous teeth

Conditions: Eruption

Summary: this investigation seeks to build upon existing evidence that a relationship exists between body mass and timing and the number of erupted teeth.

alteration in the order of teeth eruption denotes a disorder in normal development of the teeth, rather than delayed or accelerated growth. the more time deviation of teeth eruption from normal, the more possible the presence of a problem in development of teeth. for these reasons having a non-invasive tool such as body mass index to determine if development will be slower than average, could be helpful to the practitioner.

Eligibility criteria:
inclusion criteria: - healthy infants aged 5-36 months. 2-absence of medical and congenital diseases. 3-full term infants. 4-residents of cairo governorate. exclusion criteria: * presence of natal and neonatal teeth.
clinical evaluation of two daily disposable contact lenses

Conditions: Refractive Error

Summary: the objective of this study is to compare the ease of removing two daily disposable soft contact lenses off the eye.


Eligibility criteria:
inclusion criteria: 1. the subject must be between 18 and 45 years of age (inclusive)with no presbyopic add. 2. the subject must read, understand, and sign the statement of informed consent and receive a fully executed copy of the form. this should be recorded on the case report form (crf). 3. the subject must be willing to wear the study lenses for at least 8 hours per day, at least 6 days between visits. 4. the subject must be a current successful spherical soft contact lens wearer in both eyes. 5. the subject must appear willing and able to adhere to the instructions set forth in this clinical protocol. 6. the subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00d to -6.00d (inclusive) in each eye. 7. the subject's refractive astigmatism must be less than or equal to -0.75d in both eyes. 8. the subject must have corrective visual acuity of 6/9 (20/30) or better in each eye. 9. the subject must require a visual correction in both eyes (no monofit or monovision allowed). exclusion criteria: 1. any ocular or systemic allergies or diseases that may interfere with contact lens wear. 2. any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. 3. clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or infiltrates or any other abnormalities of the cornea which would contraindicate contact lens wear. 4. clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. 5. any ocular infection. 6. any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 7. currently pregnant or lactating (subject who become pregnant during the study will be discontinued). 8. diabetes. 9. infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. hiv). 10. amblyopia 11. evidence of lid abnormality or infection (including blepharitis/meibomitis) 12. conjunctival abnormality or infection. 13. any active ocular disease. 14. employee or family member of the staff of the investigational site.
phase i study in healthy male subjects comparing qgc001 to placebo

Conditions: Essential Hypertension

Summary: qgc001/1qg1 is a phase i "first time in man" study aiming to determine the overall safety and tolerability of single ascending oral doses of qgc001 in healthy male subjects compared to placebo, as well as the pharmacokinetics of qgc001 and its metabolite ec33 and the pharmacodynamic properties of qgc001 (effects on the renin-angiotensin-aldosterone system, blood pressure and heart rate) in healthy male subjects.


Eligibility criteria:
inclusion criteria: * caucasian, male healthy subjects of 18 to 45 years of age. * body weight ≥50 kg, with a body mass index calculated as weight in kg/(height in m2) from 18 to 27 kg/m2 at screening. * subjects will sign and date an informed consent form before any study-specific screening procedure is performed. * healthy, as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12 lead ecg readings. * non-smoker or smoker of fewer than 5 cigarettes per day as determined by history. must be able to abstain from smoking during the inpatient stay. * have a high probability for compliance with and completion of the study. exclusion criteria: * any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatological, haematological, neurologic, psychiatric disease or history of any clinically important drug allergy. * acute disease state within 7 days before study day 1. * history of drug abuse within 1 year before study day 1. * history of alcoholism within 1 year before day 1. consumption of more than 50 g of ethanol per day. * positive serologic findings for human immunodeficiency virus antibodies, hepatitis b surface antigen, and/or hepatitis c virus antibodies. * positive findings of urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, mdma) * history of any clinically important drug allergy. * prohibited treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product administration. * consumption of any caffeine-containing products in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 hours before study day 1. * use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen \[paracetamol\], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before investigational medicinal product administration. * donation of blood (i.e. 450 ml) within 90 days before study day 1.