Kornimate/medical-research-clean huggingface dataset:
rapid onset action of salbutamol versus formoterol

Conditions: Bronchial Asthma

Summary: the hypothesis of this study is that the onset of rapid bronchodilatory effect of inhaled formoterol (12 microgram) is comparable to that of inhaled salbutamol (200 microgram) i.e., the difference in mean forced expiratory volume in 1 second (fev1) between the 2 groups at 1, 5, 10, 30 and 60 minutes will be less than 10% in children between 5-15 years with mild acute exacerbation of asthma.

it is desirable to have a single mdi that can be used as both laba and saba. there are few studies involving few children on use of formoterol that shows rapid bronchodilatation in children with asthma and no study that used it as rescue drug in children with acute exacerbation of asthma. the purpose of the present study is to evaluate whether the rapid bronchodilatory effect of formoterol is similar to that of salbutamol in children of 5-15 years with mild exacerbation of asthma. children will receive either salbutamol or formoterol by mdi. participants will be explained about the study, spirometry and inhalation of medicine with mdi and spacer. children will receive two puffs (100 microgram each of salbutamol) or formoterol 2 puffs (6µg /puff) by mdi and spacer. each child will be explained about the inhalation technique by using a mdi of placebo. after shaking the mdi it will be attached to spacer (700ml volume) and actuated. child will be asked to take 5 tidal breaths. another puff will be given by similar method.

Eligibility criteria:
inclusion criteria: 1. children aged 5-15 years of either sex seeking treatment with mild exacerbation of asthma in pediatric chest clinic or pediatric opd 2. mild exacerbation will be defined as: * children presenting with increase in symptoms (cough, wheeze, breathlessness) for less than 7 days duration * no chest indrawing * no difficulty in speech * clinical asthma score (or pulmonary index score-annexure 1) between 6-9 exclusion criteria: 1. children with life threatening asthma detected by presence of any of the following: * severe chest indrawing * cyanosis * irregular respiration * altered sensorium 2. children with other chronic respiratory conditions like tuberculosis, cystic fibrosis or other acute illness that would complicate current treatment and response for asthma 3. if child has taken salbutamol in last 6 hours or if he is on long acting beta agonists (formoterol or salmeterol) 4. child not able to perform spirometry 5. parents refusing to give consent

Keywords: formoterol rapid bronchodilation
prevalence of hospital malnutrition in adult patients

Conditions: Malnutrition

Summary: malnutrition of patients on admission to hospitals are estimated to be as high as 60%, although the prevalence varies between countries. the impact of malnutrition on patient recovery and discharge is severe, with extensive cost implications. this study aims to assess the prevalence of at risk for malnutrition among adult patients admitted to hospital across 3 countries on the african continent.

the prevalence of malnutrition on admission to hospital varies between 15-60%. knowing the extent of the problem and identifying at-risk patients should be a priority task since malnutrition is associated with increased hospital-related complications; longer length of stay, increased costs related to treatment and higher mortality. post discharge, malnourished patients have also been linked to more frequent re-admissions, higher morbidity and mortality. various screening tools are available, including the nutrition risk screening-2002 recommended by european society for clinical nutrition and metabolism as the preferred screening tool for malnutrition in hospitals in europe. aspen recommends a more comprehensive evaluation and diagnosis procedure. in south africa, and the rest of africa, nutritional screening is not routinely done and the investigators do not have any reliable national statistics indicating the extent of the problem. the aim of this study is to determine the prevalence of malnutrition on admission to hospital and to identify the impact thereof on relevant outcomes. two different internationally recognised tools will be used and validated for the african context. in this multi-country, multi-centre descriptive cross-sectional study 3 hospitals in south africa, 1 in ghana and 2 in kenya will be included. adult patients (n=400 per hospital) will be screened on admission and at discharge and relevant outcomes (in-hospital and 3-month post-discharge) will be charted. a 50% sub-sample will be used to validate the 2 instruments.

Eligibility criteria:
inclusion criteria: * all patients older than 18 years of age * males and females * admitted to hospital within the past 48 hours * conscious * informed consent provided exclusion criteria: * paediatric patients younger than 18 years * pregnant and lactating females * patients admitted to icu, burns or relevant acute care wards * patients admitted to psychiatry or eating disorders units * patients on dialysis
covid-19 and cancer patients

Conditions: Cancer; Sars-CoV2

Summary: routinely collected data will be used to assess the morbidity and mortality of cancer patients following a positive covid-19 infection.

the sars-cov-2, (covid-19) virus of the coronavirus family is believed to have been transmitted from animal to human. on 12th march 2020, the world health organisation (who) declared this particular coronavirus outbreak a pandemic. how covid-19 affects people is still not widely understood. some people who have tested positive for the virus have been asymptomatic while others, who were otherwise well and healthy before infection, have died. currently, information obtained so far suggests that most covid-19 illness, however older people and people with severe comorbidities such as heart and lung disease and diabetes, seem to be at higher risk of developing serious covid-19 illness. this research is a retrospective, non-interventional study whose aim is to describe the features of covid-19 infection specifically in cancer patients; to investigate its severity in this particular population and evaluate the long-term outcomes by means of medical charts review of consecutive patients co-diagnosed with sars-cov-2 infection and malignancy. patients will be identified from electronic medical records and entered into a pre-designed database. all information used will have been previously collected as part of routine standard of care and will involve but is not limited to: blood test results, prior and current anti-cancer therapy, medical history and most importantly clinical outcomes, such as response to any treatment provided for covid-19 and patients' survival in relation to baseline clinic-pathologic profile. all data will be collected by each patient's team and will be anonymised and stored in a password-protected nhs computer.

Eligibility criteria:
inclusion criteria: the investigators will evaluate and include consecutive patients observed in the outpatients and inpatients facility of the study centre meeting all the following criteria: 1. be ≥18 years of age. 2. have a confirmed diagnosis of malignancy of any type. 3. have a confirmed diagnosis of sars-cov-2 infection. exclusion criteria: patients will not be entered in the study database when one or more of the following criteria are present: 1. unconfirmed diagnosis of sars-cov-2 infection 2. insufficient clinical/follow up data.
efficacy of a spirulina supplement for amelioration of benign thyroid nodules

Conditions: Benign Thyroid Nodule

Summary: clinical trial with a double-blind, placebo-controlled, crossover design; enrolls approximately 30 euthyroid patients with benign thyroid nodules, who will receive for 6 weeks a spirulina-based supplement, and for another 6 weeks placebo. thyroid ecography will be performed three times for each patient, and blood tests including tsh, free t4, free t3 and ceruloplasmin/copper will also be performed 3 times for each patient. it is expected that a decrease in the thyroid nodules occurs with the supplement administration. compared with placebo there will be a decrease of at least 20% in the volume or the largest diameter of the nodules during the 6-week administration of the supplement.

clinical trial with double-blind, placebo-controlled, crossover design; enrolls approximately 30 euthyroid patients with benign thyroid nodules, who will receive for 6 weeks a spirulina-based supplement, and for another 6 weeks placebo. * the sequence of administration supplement - placebo is unknown to the doctor or the patients * the supplement and placebo are placed in identical capsules and vials by dvr pharm * the respective capsules are administered twice a day thyroid ecography will be performed three times for each patient, and blood tests including tsh, free t4, free t3 and ceruloplasmin/copper will also be performed 3 times for each patient. * echography and blood tests will be performed for each patient initially, after 6 weeks, and after 12 weeks it is expected that a decrease in the thyroid nodules occurs with the supplement administration. * there will be a direct comparison of the nodules dimensions on the ecographic examinations, in millimeters, and of the blood levels of the molecules which reflect thyroid function

Eligibility criteria:
inclusion criteria: * euthyroid adults (normal tsh) * no criteria for malignancy is present (size, fine needle aspiration, lymph nodules) * no other medication/supplement administered for thyroid, no steroids, beta-blocker exclusion criteria: * suspicion of malignancy / shown * autoimmune disease * abnormal thyroid function * wilson disease * contraception with intrauterine device
ultrasound-guided intermediate cervical plexus block

Conditions: Internal Carotid Artery Stenosis

Summary: the investigators test with the present study design, whether an ultrasound-guided blockade of the cervical plexus in combination with an additional application of local anesthetic to the superficial cervical ansa (facial nerve: cervical branch) leads to an improved quality of anesthesia.

the innervation of the neck area is complex and includes cranial nerve (innervation of the vessel wall (ix,x) and of the neck muscles (vii,xi)), as well as the cervical plexus and brachial plexus. this is a major cause of insufficient anesthesia quality during carotid endarterectomies. the investigators test with the present prospective study design, whether an ultrasound-guided blockade of the cervical plexus in combination with an additional application of local anesthetic to the superficial cervical ansa (facial nerve: cervical branch) leads to an improved quality of anesthesia.

Eligibility criteria:
inclusion criteria: * internal carotid stenosis: open surgical revascularization * age over 18 years * written informed consent exclusion criteria: * allergy (local anesthetics) * pregnancy * participation in other studies * drug addiction * non-cooperative patients
hyper-thermia enhanced anti-tumor efficacy of trabectedin

Conditions: Sarcoma

Summary: this trial compares trabectedin alone to trabectedin in combination with regional hyperthermia in patients with high-risk soft tissue sarcoma. the study is designed to demonstrate a significant benefit for sarcoma-therapy by adding regional hyperthermia.


Eligibility criteria:
inclusion criteria: * age \> 18 years * histologically confirmed sts (primary or recurrent), except: ewing sarcoma, osteosarcoma, skeletal chondrosarcoma (extraskeletal chondrosacomas are included), gist, dermatofibrosarcoma protuberans, malignant mesothelioma, rhabdomyosarcoma * patients after failure of first-line chemotherapy (anthracyclines with/without ifosfamide) with or without rht * progressive or recurrent tumor which is unresectable or only resectable with adverse functional outcome * after macroscopic incomplete resection or marginal resection (tumor-free margins \< 1 cm) * prior chemotherapy, including anthracyclines with/without ifosfamide (with or without rht) or patients who cannot be given these medicines * at least one tumor manifestation which is eligible for hyperthermia * performance status (ecog) 0,1 or 2 * more than 3 weeks from last treatment * neutrophil count ≥ 1,5 g/l, hemoglobin ≥ 9 g/dl, platelets ≥ 100 g/l * albumin ≥ 25 g/l, total bilirubin ≤ 1 x uln, alt/ast ≤ 2.5 x uln, ap ≤ 2.5 x uln, cockroft and gault's calculated creatinine clearance ≥ 30 ml/min, cpk ≤ 2.5 x uln * patients with the ability to follow study instructions and likely to attend and complete all required visits * written informed consent of the subject exclusion criteria: * uncontrolled infection (e.g. active viral hepatitis) * unstable cardiac status * peripheral neuropathy \> grade 2 * known or persistent abuse of medications, drugs or alcohol * other malignancy during the last 5 years (exclusion of basal cell carcinoma or adequately treated cervical carcinoma in situ) * prior therapy with tr or known history of hypersensitivity to drugs with a similar chemical structure * pregnancy or breast-feeding * females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration * uncontrolled cns-metastases * medical or technical impossibility for hyperthermia to heat the major target lesion

Keywords: high-risk soft tissue sarcoma trabectedin
fatty acid taste rating with or without sour taste adaptation

Conditions: Taste, Altered

Summary: we are trying to figure out whether the fatty acid taste is differentiated from sour taste.

participants will be asked to provide general demographic information such as gender, age and ethnicity. their height and weight will be measured. then, they will be trained with one of the sample solutions for intensity rating and adaptation to sour taste. there will be eight different sample solutions containing sucrose esters, xanthan gums to help fatty acids stay dissolved, and either acetic acid for sour compounds or, butyric acid, caproic acid, caprylic acid, capric acid, lauric acid, oleic acid, or linoleic acid for fatty acid taste. 2 g of each palmitic acid and stearic acids in solid form (their melting points are above body temperature) will also be placed in participants' mouth. all of these compounds are common in the commercial food supply. the study procedure entails two sets of taste intensity ratings without (test a) or with (test b) sour taste adaptation. for test a, participants will taste one of the eight solutions or one of solid fatty acids, and rate its intensity before and after expectorating it. they will not swallow any samples and they will rinse their tongues thoroughly with 1% ethanol solution and water after expectorating the solution. they will consume one piece of unsalted cracker and rinse their tongues thoroughly again. before moving to the next step, they will be asked to describe the taste quality of the sample solution they just tasted. they will repeat this procedure with the rest of the sample solutions. for test b, participants will follow the same procedure of taste intensity ratings but with sour taste adaptation. for sour taste adaptation, the participants will hold sour taste solutions in their mouth for 5 seconds and rate its taste intensity. they will repeat rating the sourness until they rate its intensity as less than weak. when they feel the sour taste solution weak, they will taste one of the eight solutions and repeat the intensity rating with one of the sample solutions. after the taste intensity rating, the participants will be asked to describe the taste quality of the sample solution they just tasted. they will repeat this procedure with the rest of the sample solutions. the participants will do both test a and b twice in random order on two separate days. taste testing is expected to take 1 hour each day. they will receive $20 at the end of the two test days as compensation for their participation.

Eligibility criteria:
inclusion criteria: - exclusion criteria: * taste disorder no allergy to alcohol
caudal epidural block and dpnb in hypospadias

Conditions: Hypospadias; Postoperative Pain

Summary: hypospadias, seen in every 200-300 births, is one of the most common congenital anomalies of the penis and is defined as the urethral meatus being located in the ventral part of the penis instead of its normal place. the surgery of this anomaly is very painful in the postoperative period and requires long-term analgesia. regional anesthesia methods combined with general anesthesia play an important role in providing effective and long-term postoperative pain control in pediatric penile surgery. these methods also reduce postoperative morbidity, enable early mobilization and significantly decrease the need for narcotic analgesics. the investigator's hypothesis is peripheral nerve blocks are superior to neuraxial blocks as the blocks provide longer-term analgesia and have fewer side effects.

the surgery of hypospadias is very painful in the postoperative period and requires long-term analgesia. a dorsal penile nerve block (dpnb) and caudal epidural block (ceb) are commonly used regional anesthesia techniques for postoperative pain control. aims: the primary aim of the current study was to use the duration until the first postoperative analgesic requirement after two different block techniques to compare the analgesic effect. the secondary aims were to compare the two methods for postoperative children's hospital eastern ontario pain scale (cheops) scores, complications and parental satisfaction scores.

Eligibility criteria:
inclusion criteria: * 1-7 years of age * asa (american society of anesthesiologists) i-ii group * scheduled for distal hypospadias surgery * able to communicate in turkish * willing to participate to the study (parents and children) exclusion criteria: * less than 1 or more than 7 years of age * a neurological deficit, bleeding diathesis, or a history of local anesthetic allergy; an infection or redness in the injection area, congenital low back anomaly, liver disorder, a psychiatric disorder, mental retardation, or communication problems detected during examination * unwilling to to participate to the study ((parents or children)

Keywords: dorsal penile nerve block caudal epidural block postoperative pain analgesia hypospadias ultrasound
epidural analgesia in different cervix diameter and the rate of cesarean delivery

Conditions: Labor Pain

Summary: epidural analgesia in the early stage of labor at cervix \< 4.0cm was considered as a risk period for increasing the rate of cesarean delivery. the more recent studies and the investigators' previous data indicated epidural analgesia can be performed as early as the cervical dilation approximately 2.0cm. the investigators hypothesized that different cervix diameter had different rate of cesarean delivery. this trial would investigate the correlation amongst different cervical dilation and the risk of cesarean section in nulliparous women at term.


Eligibility criteria:
inclusion criteria: 1. nulliparous women 2. \> 18 years and \< 45 years 3. spontaneous labor 4. analgesia request exclusion criteria: 1. allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records 2. participants younger than 18 years or older than 45 years 3. those who were not willing to or could not finish the whole study at any time 4. using or used in the past 14 days of the monoamine oxidase inhibitors 5. alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics; 6. subjects with a nonvertex presentation or scheduled induction of labor 7. cervical dilation was 5.0cm or greater before performing epidural puncture and catheterization. 8. diagnosed diabetes mellitus and pregnancy-induced hypertension 9. twin gestation and breech presentation.

Keywords: epidural analgesia patient-controlled analgesia
the effect of music by mozart on energy expenditure in growing preterm infants

Conditions: Preterm Infants

Summary: music has been consistently shown to reduce stress and increase weight gain in premature infants. the mechanism of this presumed improved metabolic efficiency is unknown. we aim to test the hypothesis that music by mozart reduces energy expenditure in growing healthy preterm infants.


Eligibility criteria:
inclusion criteria: * appropriate weight for gestational age * postmenstrual age of 30-37 weeks * gavage fed * tolerating full enteral feedings without significant gastric residuals (\>5% of total feed) * no electrolyte imbalance exclusion criteria: * congenital anomalies * dysmorphism * intracranial hemorrhage of any grade * periventricular leukomalacia * necrotizing enterocolitis * supplemental oxygen requirements by 28 days of age or by 36 weeks of postmenstrual age and at least 1 week prior to measurement * active infection * patent ductus arteriosus * apnea of prematurity

Keywords: metabolic rate music preterm infants energy expenditure nidca
phase 1 to investigate safety, tolerability, pk/pd of j2h-1702 in healthy females

Conditions: Non-alcoholic Steatohepatitis

Summary: - objectives: primary objective_to evaluate the safety and tolerability after single oral administration of the investigational product (ip), j2h-1702 in healthy female subjects. secondary objective_to evaluate the pharmacokinetics (pk) and pharmacodynamics (pd) characteristics after single oral administration of the ip, j2h-1702 in healthy female subjects.

- study methodology: 6 subjects will be randomized to the study group (j2h-1702 group) and 2 subjects will be to the placebo group. ae, vs, ecg, lab tests will be evaluated to check the safety, tolerability and pk/pd.

Eligibility criteria:
inclusion criteria: 1. healthy females aged ≥ 19 and ≤ 45 years 2. subjects with a body mass index (bmi) ≥ 18.0 to ≤ 27.0 kg/m2 3. subjects confirmed to be clinically healthy based on the medical history, physical examination, vital signs, electrocardiogram (ecg), and appropriate clinical laboratory tests 4. agree to use dual contraceptive methods and not to donate eggs 5. voluntarily agree to participate in the study exclusion criteria: 1. a subject who had or has the disease corresponding to clinically significant liver, etc. 2. a subject with a history of gastrointestinal diseases or surgery 3. a subject who has a history of clinically significant hypersensitivity to drugs containing 11β-hsd1 inhibitor 4. a subject who has genetic problems such as galactose intolerance, lap galactose intolerance, lap lactase deficiencies, or glucose ∙galactose malabsorptivity, etc. 5. one who has drug abuse and one who is positive response in urine drug screening tests 6. a subject with abnormal vital signs at the screening visit 7. a subject who has participated in another clinical trial or bioequivalence test 8. a subject who donated whole blood or the ingredient, or received blood transfusion 9. a subject who took drug metabolizing enzyme-inducing and inhibitory drugs 10. a subject who consumes grapefruit/caffeine-containing food 11. a subject who took any prescription drug or herbal medicine or took any over the counter drug (otc) 12. high caffeine intaker, high alcohol intaker or excessive smoker 13. a subject who cannot eat meals provided by the clinical trial institution. 14. a subject who participated in this trial and were administered the investigational product. 15. a subject who is positive for serum test 16. a pregnant or breast-feeding subject 17. a subject who the investigator deems inappropriate for this clinical trial