Kornimate/medical-research-clean huggingface dataset:
omnaris versus levocetirizine phase 4 study

Conditions: Allergic Rhinitis

Summary: this i a comparison of the efficacy ciclesonide nasal spray and levocetirizine, alone and in combination.

randomized, open-label, three arm, parallel group, multi-center study

Eligibility criteria:
inclusion criteria: * allergic rhinitis patients aged ≥ 18 years (with a history of ar of 1 years or longer) * moderate to severe patient according to aria guideline * to have a demonstrated positive skin prick test or other serologic tests to at least 1 allergen. * subjects who complete the subject diary(s) at least 70%. exclusion criteria: * nasal pathology, including nasal polyps, clinically relevant respiratory tract malformations, recent nasal biopsy (within 60 days), nasal trauma, nasal surgery, atrophic rhinitis, rhinitis medicamentosa (within 60 days), asthma requiring corticosteroid treatment * hypersensitivity to corticosteroid and/or hydroxyzine * hypersensitivity to galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption * a history of respiratory tract infection or disorder within 2 weeks of the screening visit or had a respiratory tract infection during baseline * active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of β-agonists * treated with systemic corticosteroids (within 8 weeks of study initiation) or topical corticosteroids (\> 1% hydrocortisone, within 4 weeks of study initiation) or antibiotics (within 2 weeks of first visit)

Keywords: efficacy ciclesonide levocetirizine allergic rhinitis
group exercise program supported by audiovisual media during hemodialysis

Conditions: Chronic Kidney Failure; Hemodialysis; Sarcopenia; Functional Capacity; Muscle Strength Dynamometer; Physical Activity Level

Summary: people with chronic kidney disease (ckd) undergoing hemodialysis (hd) experience muscular complications, such as sarcopenia, which worsen their functional capacity and increase mortality. exercise programs during hd are an effective strategy to combat sedentary behavior, and implementing them through innovative technologies could facilitate their adoption in clinics, benefiting more patients. therefore, the study's objectives are to assess the feasibility and safety of a group exercise program supported by audiovisual media conducted during hd sessions. additionally, it will analyze factors influencing adherence, identify potential causes for interruptions or failure to perform the prescribed exercise, and evaluate the risk and prevalence of sarcopenia, its association with low muscle strength, poor muscle quality, and physical inactivity.

a 4-week randomized experimental study will be conducted, using an exercise protocol during hd, broadcast simultaneously on television. the frequency of exercise completion, reasons for non-completion, adverse events, as well as sarcopenia, muscle strength, muscle characteristics through ultrasound and electrical bioimpedance, and physical activity levels will be evaluated.

Eligibility criteria:
inclusion criteria: * over 18 years old of both sexes; * undergoing hd for at least three months in three sessions per week, four hours, totaling 12 hours per week. exclusion criteria: * lower limb amputations; * neurological, musculoskeletal, or osteoarticular disorders; * severe and unstable comorbidities; * undergoing high doses of corticosteroids (\>30 mg/day); * inability to understand the measurement methods used.

Keywords: chronic kidney failure hemodialysis exercise sarcopenia muscle strength functional capacity dynamometer physical activity level
high dose baya1040_nifedipine: a dose-comparative study

Conditions: Hypertension

Summary: this is a clinical study evaluating the superiority in efficacy and assess safety and tolerability of baya1040_nifedipine 80 mg/day (40 mg twice daily) compared with baya1040_nifedipine 40 mg/day (40 mg once daily) in patients with essential hypertension who are not at target blood pressure by baya1040_nifedipine 40 mg once daily treatment.


Eligibility criteria:
inclusion criteria: * 20 years or older * japanese male or female * outpatient with essential hypertension * patients whose sitting diastolic blood pressure (dbp) is 90 mmhg or more despite more than 4 weeks of treatment with antihypertensive drug exclusion criteria: * sitting diastolic blood pressure (dbp) is 110 mmhg or more or sitting systolic blood pressure (sbp) is 180 mmhg or more * patients with secondary hypertension or hypertensive emergency

Keywords: baya1040_nifedipine nifedipine essential hypertension japanese patients phase iii 13176
a phase 2 trial of rebamipide liquid to determine the effective dose for prevention of chemoradiotherapy-induced oral mucositis in patients with head and neck cancer

Conditions: Head and Neck Cancer

Summary: to investigate the efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer following administration of rebamipide and to determine the optimal dose of rebamipide.


Eligibility criteria:
inclusion criteria: * head and neck cancer patients scheduled for definitive or postoperative chemoradiotherapy. * patients with a histopathological diagnosis of head and neck cancer and primary tumor in one of the following regions. 1. definitive therapy: nasopharynx, oropharynx, hypopharynx, or larynx 2. postoperative therapy: oral cavity, oropharynx, hypopharynx, or larynx * patients with no history of chemotherapy, radiotherapy, or chemoradiotherapy for head and neck cancer * patients with an eastern cooperative oncology group (ecog) performance status score of 0 or 1 * patients who are able to hold fluid in the mouth * patients who are able to swallow the investigational medicinal product (imp) * patients expected to survive for at least 3 months * patients who have given written informed consent in person * patients who can stay at or visit the hospital for scheduled examinations and observations * patients who are able to take contraceptive measures to avoid pregnancy of the patient or their partner from the time of informed consent until 4 weeks after completion of imp administration exclusion criteria: * patients with primary malignant tumors other than head and neck cancer. * patients with symptomatic viral, bacterial, or fungal infection * patients with serious renal impairment * patients with distant metastasis * patients with severe complications (uncontrolled cardiac disease, diabetes, hypertension, etc) * patients with any of the following laboratory test results: 1. neutrophil count: \<1500 l 2. platelet count: \<75000 l 3. hemoglobin: \<10.0 g/l 4. aspartate aminotransferase (ast): \>3 times the upper limit of the reference value at the trial site 5. alanine aminotransferase (alt): \>3 times the upper limit of the reference value at the trial site 6. serum bilirubin: \>1.5 times the upper limit of the reference value at the trial site 7. serum albumin: \<3.0 g/dl 8. serum creatinine: \>1.5 the upper limit of the reference value at the trial site 9. creatinine clearance : \<30 ml/min * patients complicated with autoimmune disease * patients requiring continuous systemic administration of glucocorticoid * female patients who are pregnant or lactating, who may possibly be pregnant, or who wish to become pregnant * patients who have participated in any other clinical trial within 4 weeks prior to initiation of chemoradiotherapy * patients who have a history of drug allergy to rebamipide, cisplatin, or other platinum compounds * patients who are otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the trial
sems placement followed by chemotherapy and surgery for obstructing left-sided colonic cancer

Conditions: Complication of Treatment

Summary: this study aimed to evaluate the safety and feasibility of sems followed by neoadjuvant chemotherapy prior to elective surgery for obstructing left-sided colon cancer.

stoma is reported to be frequent in self-expanding metallic stent (sems) treated patients with obstructing left-sided colon cancer than in those with non-obstructing surgery. retrospective study reported worse overall survival with sems and elective surgery than with emergency surgery in patients with left-sided malignant colon obstruction. in practice, intestinal wall edema following stent placement increases the difficulty of surgery, and this could be a major problem if the interval between stent insertion and surgery is short (1-2 weeks). the patients with obstructing left-sided colon cancer received sems treatment, and the recevied neoadjuvant chemotherapy prior to elective surgery.

Eligibility criteria:
inclusion criteria: 1. histologically proven adenocarcinoma located in the left colon (between the splenic flexure and 15 cm proximal to the anal margin) 2. eastern cooperative oncology group (ecog) performance status of from 0 to 2 exclusion criteria: 1. history of any other cancer 2. multiple primary colorectal cancers 3. distant metastases 4. hereditary nonpolyposis colorectal cancer 5. familial adenomatous polyposis

Keywords: left-sided colonic tumor intestinal obstruction self-expanding metallic stent neoadjuvant chemotherapy stoma
parecoxib for pain management after total knee arthroplasty and total hip arthroplasty

Conditions: Pain, Postoperative

Summary: evaluated the effect of perioperative parecoxib administration on postoperative pain, analgesic use, function recovery, inflammatory response and bleeding risk.

non-steroid anti-inflammatory drugs are recommended for multimodal postoperative pain management. we evaluated the effect of perioperative parecoxib administration on postoperative pain, analgesic use, function recovery, inflammatory response and bleeding risk.

Eligibility criteria:
inclusion criteria: 1. male or female patients who have underwent primary unilateral total knee arthroplasty (tka) and total hip arthroplasty (tha). 2. age between 18-65 years. 3. chinese ethnicity. exclusion criteria: 1. patients who underwent a reversion or a previous tka or tha, emergency tka, or tka as result of a trauma. 2. patient exhibited allergy to parecoxib sodium. 3. lactating or pregnant. 4. any other conditions not suitable for surgery as evaluated by the surgeon in charge.

Keywords: preemptive analgesia parecoxib sodium total knee arthroplasty total hip arthroplasty
measuring neuroadaptations in response to very low nicotine content cigarettes

Conditions: Tobacco Dependence

Summary: the overall goal of this study is to determine if switching to very low nicotine content cigarettes changes the function of brain circuitry involved in incentive salience and executive control among dependent smokers.

in a double-blind, randomized controlled trial, dependent smokers will be randomized to a 6-week very low nicotine content (vlnc) cigarette condition (n=50) or a 6-week normal nicotine content cigarette control condition (nnc; n=25). participants will undergo functional magnetic resonance imaging (fmri) scans at baseline and 6-weeks to investigate the nicotine-related modulation of brain circuitry involved in incentive salience valuation and executive control. imaging tasks will engage the incentive salience of smoking cues and non-smoking rewards and executive control functions to identify changes in functional activity within, and effective connectivity between, known salience and executive control brain circuitry. a novel fmri task using specialized odor presentation equipment and fmri sequences will assess neural cue reactivity to smoke odors.

Eligibility criteria:
inclusion criteria: * 21-60 years old * smoke \>5 cigarettes per day * \>1 year of daily smoking * no quit attempt in prior month and not planning to quit smoking within next 3 months * able to understand and consent to study procedures * high school or lower educational attainment or annual household income \< $50,000 * plan to live in local area next 3 months * women not pregnant or nursing and taking steps to avoid pregnancy * able to read and write in english * access to computer with internet service that allows for zoom exclusion criteria: * use of non-cigarette tobacco products in the past 7 days * use of illicit substances more than once a week in the past 3 months (excluding marijuana) * current alcohol abuse impairing participation * mri safety contraindications (e.g., metal implants, claustrophobia) * unstable or significant medical conditions (e.g., chronic obstructive pulmonary disorder, coronary heart disease) * major neurological conditions or brain trauma * major surgeries planned in next 3 months * use of smoking cessation medication in prior month (e.g., varenicline, patch) * uncontrolled serious mental illness, suicidality, or inpatient psychiatric hospitalization in the past 6 months * unwillingness to provide urine samples * unwilling to smoke study assigned cigarettes for the remainder of the trial * plans to move or take extended travel out of the area in the next 3 months * any other condition or situation that would, in the investigator's opinion, make it unlikely that the participant could comply with the study protocol * self-reported color blindness * left-handedness * smell dysfunction as determined via standardized assessment

Keywords: tobacco nicotine smoking functional magnetic resonance imaging addiction
comorbidity burden and use of concomitant medications at cml diagnosis

Conditions: Chronic Myeloid Leukemia

Summary: the aim of the retrospective study was to further characterize the prevalence of comorbid conditions as well as the use of concomitant medications in newly diagnosed cml patients in a real-world setting. hematologists from ten polish hematological tertiary care centers were asked to analyze medical records for all consecutive cml patients diagnosed with chronic phase cml between january 1st 2005 and december 31st 2014.

all three tkis used as first line treatment of cml, (imatinib, dasatinib and nilotinib), may be associated with the so called "off-target" effects causing specific adverse events (aes). interestingly, some co-morbidities may predispose towards developing these specific tkis' "offtarget" aes. the aim of the retrospective study was to further characterize the prevalence of comorbid conditions as well as the use of concomitant medications in newly diagnosed cml patients in a real-world setting. hematologists from ten polish hematological tertiary care centers were asked to analyze medical records for all consecutive cml patients diagnosed with chronic phase cml between january 1st 2005 and december 31st 2014. data were collected through on-line case report form of the polish adult leukemia group (palg) registry. baseline patients' characteristics including sex, age, body mass index (bmi), risk group according to sokal score, as well as comorbidities and concomitant therapies, were recorded at the time of cml diagnosis. the study was conducted in accordance with the provisions of the declaration of helsinki.

Eligibility criteria:
inclusion criteria: * 1) age ≥ 18 years; 2) diagnosis of chronic phase cml between january 1st 2005 and december 31st 2014. exclusion criteria: * primary diagnosis of cml in accelerated or blastic phase
impact of covid-19 pandemic on the psychological wellbeing of healthcare professionals in india

Conditions: Psychological Stress

Summary: to study the epidemiology of psychological distress among healthcare professionals of max super speciality hospital,saket ,new delhi in india during the covid-19 pandemic and assess the implications for providing psychological interventions(or therapeutic services)

to study the epidemiology of psychological distress among healthcare professionals of max super speciality hospital,saket ,new delhi in india during the covid-19 pandemic and assess the implications for providing psychological interventions(or therapeutic services). hypothesis: there is likelihood of psychological distress impacting healthcare professionals' mental well-being as a result of their role in the healthcare setup during the covid-19 pandemic. study design-the questionnaire assessing the psychological wellbeing shall be administered via digital means of communication to healthcare professionals and support staff (doctors, nurses, paramedics, front office and support staff) across max super speciality hospital, saket, new delhi that currently employs 1295 individuals in the current category. participation in the study will be voluntary and informed consent will be sought prior to the survey administration. participants' responses will remain anonymous, with an assurance of confidentiality.

Eligibility criteria:
inclusion criteria healthcare professionals working in max super speciality hospital saket new delhi healthcare professionals inclusive of doctors, nurses paramedics front office employee and support staff healthcare professionals above 18 years of age healthcare professionals residing in india exclusion criteria non-employees of max super speciality hospital saket new delh healthcare professionals residing outside india
robustness check of placement and measurement algorithms for blood flow measurement on common carotid artery

Conditions: Coronary Artery Disease; Aortic Valve Disease; Mitral Valve Disease

Summary: this study is set up to test the robustness of algorithms and models and to optimize them. furthermore, data are used to investigate the influence of probe orientation on parameters of the common carotid artery.

this study has four objectives: 1. determine the robustness of the placement and measurement algorithms with ultrasound images, obtained with different ultrasound system settings and probe movements. 2. verificate and optimize the arterial blood flow model. 3. determine the variation in location and size of the arteries and veins in the area around the common carotid artery. 4. determine the influence of probe orientation on parameters obtained from ultrasound measurements of the common carotid artery. sample size and missing data due to limited time in the operating room, the measurement protocol is divided into four parts. per protocol part data of 25 patients is deemed sufficient to be able to answer the above-mentioned objectives, which would result in a total of 100 inclusions. however, the investigators expect to perform more than one measurement protocol per patient, due to which a total of 75 inclusions is needed. patients of whom the data is qualitatively too low to be used for analysis will be replaced. as such, the investigators make sure to have qualitatively good data of 25 patients per protocol part.

Eligibility criteria:
inclusion criteria: * adult (\>18 years) patients. * participant should be able to provide informed consent in dutch. exclusion criteria: * participant has a known stenosis of the carotid artery. * patient has open wounds in the measurement area (area in the neck around the carotid artery).

Keywords: common carotid artery ultrasound
feasibility and safety of intranasally administered breast milk in hie

Conditions: Hypoxic Ischaemic Encephalopathy (HIE); Hypoxic Ischemic Encephalopathy of Newborn; Neonatal Encephalopathy; Neonatal Hypoxic Ischemic Encephalopathy; Brain Injury; Perinatal Asphyxia; Perinatal Asphyxia , Moderate to Severe HIE

Summary: this is a prospective intervention single center study to evaluate the feasibility and safety of intranasal breast milk in hypoxic-ischaemic encephalopathic neonates receiving therapeutic hypothermia.

perinatal asphyxia and the resulting hypoxic-ischemic encephalopathy (hie) are the leading cause of neonatal mortality and long-term neurodevelopmental disabilities. based on our current knowledge, therapeutic hypothermia is the only therapy that has been proven to reduce central nervous system damage in hie neonates. improving neurodevelopmental outcomes of newborns with hie has been an intense area of research over the past decade. breast milk is a complex biological substance that contains a variety of bioactive components including neurotrophic growth factors, cytokines, immunoglobulins, and multipotent stem cells. studies have shown that exclusive breastfeeding in the early stages of development has a positive impact on cognitive outcomes. animal studies support that mesenchymal stem cells and neurotrophic substances found in breast milk, when administered intranasally enter the central nervous system and reduce the extent of neurological damage. in preterm infants, it has been shown that intranasally administered breast milk is safe and well-tolerated. in this prospective study our aim is to assess the feasibility and safety of intranasally delivered breast milk to hie infants treated with hypothermia. our objective is to administer fresh, own-mother's breast milk intranasally to neonates with hie starting from the first day of life and continuing for 1 month. feasibility will be based on the ability to initiate treatment within 48 hours of birth using own mother's fresh milk expressed within 4 hours and continuing treatment after discharge until day 28. safety will be assessed through monitoring vital signs and documenting any adverse events. time to reach full enteral feeding and lengths of exclusive breast feeding will be recorded and analyzed.

Eligibility criteria:
inclusion criteria: * moderate or severe hypoxic- ischaemic encephalopathy, receiving therapeutic hypothermia * ≥ 35. gestational week * \< 48 hours of life * hypothermia treatment for 72 hours * parental consent form exclusion criteria: * congenital malformation * concurrent cerebral lesions * ecmo therapy * contraindication of lactation * mother unable or unwilling to provide fresh breast milk * postpartum asphyxia

Keywords: hypoxic-ischaemic encephalopathy neonatal encephalopathy perinatal asphyxia breast milk breast milk stem cells intranasal breast milk
specific stabilization exercise with ultrasound feedback for patient with recurrent low back pain

Conditions: Recurrent Low Back Pain

Summary: 1. specific aim 1:identify factors that influence muscle performance by use of ultrasound imaging. hypothesis: gender, age, and bmi affect the muscle performance of deep trunk muscles. 2. specific aim 2. to compare the performance of trunk deep muscles (transversus abdominis and multifidus) and the sensation and pain thresholds of patients with recurrent low back pain with asymptomatic subjects. hypothesis: patients with recurrent low back pain have: (a) less activation of the transversus abdominis and multifidus, (b) peripheral and central sensitization, with decreased sensation and pain thresholds in the lumbar and foot areas. 3. specific aim 3. to determine the performance of the transversus abdominis and multifidus, and the sensation and pain thresholds by use of ultrasound feedback training in asymptomatic adults, and to compare these results with the traditional training protocols for trunk stabilization. hypothesis: specific stabilization exercise using ultrasound feedback training is more effective in activating deep trunk muscles and increasing sensation and pain thresholds than the traditional stabilization training protocol in asymptomatic adults. 4. specific aim 4. to determine the performance of the transversus abdominis and multifidus, and the sensation and pain thresholds by using the ultrasound feedback training in adults with low back pain, and to compare these results with the traditional training protocols for trunk stabilization. hypothesis: specific stabilization exercise using ultrasound feedback training is more effective in activating deep trunk muscles and increasing sensation and pain thresholds than the traditional stabilization training protocol in adults with low back pain.


Eligibility criteria:
inclusion criteria: * recurrent low back pain for at least the past year * lumbar region discomfort more than one day in the past three months * recurrent discomfort more than one time in the past three months exclusion criteria: * pregnancy * carcinoma * systematic disease (rheumatic arthritis, ankylosing spondylitis etc) * had surgery on lumbar region or lower extremities * neurological symptom on lower extremities(numbness, pain etc) * spondylolisthesis

Keywords: specific stabilization exercise ultrasound low back pain