Kornimate/medical-research-clean huggingface dataset:
effect of chronic arsenic exposure on malnutrition of under five children

Conditions: Malnutrition, Child; Arsenic Poisoning Chronic

Summary: early life malnutrition is associated with later life health problems, particularly stunting, which is a height-for-age z score less than -2 standard deviation of world health organization median.underweight is weight-for-age z score less than -2 standard deviation of world health organization median. wasting is weight -for- height z score less than -2 standard deviation of world health organization median.

prevalence of under-five stunting, wasting and underweight are 21% and , 8% and 6% respectively in egyptian demographic health survey 2014. the main risk factors for growth restriction in children are maternal under nutrition during pregnancy, lack of exclusive breastfeeding, inappropriate complementary feeding and micronutrient intake and high prevalence of enteric infections. however, other environmental exposures may also play a role in growth restriction . high concentrations of arsenic, lead and cadmium in placenta are associated with poor fetal out come and low birth weight. arsenic crosses the placenta causing suppression of insulin-like growth factor 1. when breastfeeding is exclusive, infants are unlikely to be exposed to arsenic by other routes of exposure such as external foods, drinking water and foods made at home using arsenic contaminated water. rational of the study. improvement of under-five nutritional status is a global target. although the exposure to arsenic has increased globally, it's impact on nutritional status has seldom been investigated.

Eligibility criteria:
inclusion criteria: female children from 2 to 5 years exclusion criteria: severely ill children other than severely malnourished. * children with congenital anomaly. * relatives.
a study of mt-4561 in patients with various advanced solid tumors

Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC); Non-small Cell Lung Cancer (NSCLC); Esophageal Cancer; Gastric Cancer; Biliary Tract Cancer; Pancreatic Ductal Adenocarcinoma (PDAC); Breast Cancer; Ovarian Cancer; Cervical Cancer; Endometrial Cancer; Prostate Cancer; Urothelial Carcinoma; Neuroendocrine Tumor (NET); Neuroendocrine Carcinoma (NEC); Soft Tissue Sarcoma; NUT Carcinoma

Summary: this is a first in human (fih), multicenter, open-label, phase i/ii study to evaluate safety, tolerability, pharmacokinetics (pk), pharmacodynamics, and efficacy of mt-4561 in patients with advanced solid tumors. this study will be conducted in 3 parts. part 1 is aimed at evaluating safety, tolerability, pk and pharmacodynamics of mt-4561 and determining the maximum tolerated dose (mtd) using the bayesian optimal interval (boin) design. the study details and doses of part 2 (dose-optimization) and part 3 (drug-drug interaction) will be available after review of applicable part 1 results.


Eligibility criteria:
main inclusion criteria: * male or female patient aged 18 years or older at the time of signing the informed consent form * ≥ 1 measurable lesion by the recist v1.1 and ≥ 1 disease site for tumor biopsy * eastern cooperative oncology group performance status: 0 to 1 * life expectancy of at least 3 months * adequate bone marrow function * adequate hepatic function * adequate renal function estimated creatinine clearance ≥ 60 ml/min calculated using the cockcroft and gault equation or by institutional method * part 1: patients must have a confirmed histologic or cytologic diagnosis of one of the following solid tumors for participation in the study: head and neck squamous cell carcinoma (hnscc), non-small cell lung cancer (nsclc), esophageal cancer, gastric cancer, biliary tract cancer, pancreatic ductal adenocarcinoma (pdac), breast cancer, ovarian cancer, cervical cancer, endometrial cancer, prostate cancer, urothelial carcinoma, neuroendocrine tumor (net) or neuroendocrine carcinoma (nec), soft tissue sarcoma, and nut carcinoma. main exclusion criteria: * patients with active brain or leptomeningeal metastases * any unresolved toxicity ≥ grade 2 from previous anticancer therapy except for alopecia * prior systemic anticancer therapy within 4 weeks before first dose of investigational medicinal product (imp) or 5 half-lives, whichever is shorter, and prior radiotherapy within 2 weeks before first dose of imp * history of congenital long qt syndrome or clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation or torsades de pointes) * patients who received drugs with a known risk of qt interval prolongation or torsades de pointes within 14 days or 5 half-lives, whichever is longer, before the start of imp administration * qt interval corrected for heart rate using fridericia's correction (qtcf) \> 470 msec at screening
expiratory rib cage compression in mechanically ventilated patients

Conditions: Pulmonary Infection

Summary: this is a randomized crossover study, designed to evaluate if the manual expiratory rib cage compression technique improves respiratory mechanics and is effective in secretion removal in mechanically ventilated patients.

chest physiotherapy is an essential component of the multidisciplinary approach in critical care settings. in this context, a number of devices and manual techniques have been used to remove pulmonary secretions and re-expand collapsed areas. this study was designed to evaluate whether manual rib cage compression improves airway clearance and respiratory mechanics in mechanically ventilated patients. in a randomized crossover trial, 20 mechanically ventilated patients underwent thoracic manual compression and control intervention (normal ventilation) at the same day. the main outcomes were sputum production and the changes in respiratory mechanics.

Eligibility criteria:
inclusion criteria: * patients under mechanical ventilation * diagnosis of pulmonary infection * hypersecretive (defined as the interval between tracheal suctioning \< 2 hours) exclusion criteria: * haemodynamic instability (defined by heart rate \> 130 bpm and mean arterial pressure \< 60 mmhg) * use of vasopressor drugs * absence of respiratory drive * acute bronchospasm * acute respiratory distress syndrome * atelectasis (identified by an independent radiologist that was not participating in the study) * untreated pneumothorax * lung haemorrhage.

Keywords: mechanical ventilation chest physiotherapy critical care pneumonia mechanically ventilated patients with pulmonary infection.
expanded quantitative urinary culture (equc) vs standard culture (suc) techniques in the clinical care

Conditions: Urinary Tract Infections

Summary: this purpose of this study is to see if expanded urine culture techniques used in the laboratory improve the clinical care of women over standard urine culture techniques.

the investigators request permission to recruit 225 women who respond "yes" to the question "do you feel you have a urinary tract infection". all participants will provide baseline urine specimens obtained by transurethral catheter (to avoid vulvo-vaginal contamination) and will complete a utisa questionnaire to assess their current urinary tract symptoms. participants will be randomized to the suc treatment algorithm or the equc treatment algorithm. treating physicians will receive either the suc results or the equc results from the clinical laboratory and the results will be part of their clinical record. treating physicians will follow the loyola fpmrs treatment algorithm. women in the study will also give consent for us to contact them using email, text messaging or phone call within 7-10 days after "treatment plan" has been implemented. the treatment plan options will include no treatment if the culture results show no pathogenic bacteria. all participants will be queried 7-10 days after their treatment plan (by email or text) "do you feel you continue to have a urinary tract infection". women who respond "yes' will be asked to return for a second urine specimen which is our standard protocol. the second urine specimen will be analyzed using equc culture techniques only. again, a treatment plan will be developed by the attending physician and the patient participant will be queried 7-10 days after the plan is implemented.

Eligibility criteria:
inclusion criteria: * a "yes" answer to the screening question "do you feel you have a uti"? * non-pregnant women ages 18 years or older * agreement to respond to a text or email question 7-10 days after treatment plan for their uti (note: the treatment plan may include "no treatment"). exclusion criteria: * women currently on antibiotics * patients who cannot communicate or read in english * patients under the age of 18 * pregnant patients * women with an indwelling catheter and intermittent self-catheterization * men * urine obtained via the "clean catch method" (i.e. voided urine) * women who refuse to be catheterized * women who cannot or will not agree to respond to an email or text message 7-10 days after treatment plan is initiated.
comparison of salmeterol and fluticasone propionate absorption from salmeterol/fluticasone easyhaler with seretide diskus

Conditions: Asthma

Summary: the purpose of this study is to compare the test product salmeterol/fluticasone easyhaler with the reference product seretide diskus in terms of drug absorbed in the bloodstream.


Eligibility criteria:
inclusion criteria: * healthy males and females aged 18-60 years * normal weight, at least 50 kg exclusion criteria: * evidence of clinically significant cardiovascular, renal, hepatic, haematological, gi, pulmonary, metabolic-endocrine, neurological or psychiatric disease * any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study * any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study * known hypersensitivity to the active substance(s) or the excipient of the drug * pregnant or lactating females
the effects of music therapy on adult patients requiring mechanical ventilation in the icu

Conditions: Acute Respiratory Distress Syndrome; Acute Hypoxemic Respiratory Failure; Acute Hypercapnic Respiratory Failure

Summary: while most studies in the medical literature that indicate "music" as an intervention may recognize its impact and capacity to decrease pain perception, anxiety, and/or its role in the regulation of cardiac and respiratory function in icu patients, no identifiable studies have implemented entrained live music therapy protocols into clinical trials. music therapy treatment is a non-pharmacological intervention that is individually tailored to the patient's needs and focuses on the assessment and intervention of a specific music application that is provided by a certified music therapist. entrained music therapy focuses on a dynamic interaction between the patient and music therapist in which the music therapist attempts to promote relaxation and comfort through the patient's identified song of kin (sok). this study measures the effects of live music therapy entrained to the vital signs of adult patients on duration of mechanical ventilation.

the study will include 178 adult patients on mechanical ventilation. these patients will be randomly assigned to the music therapy group or control group and matched for diagnosis, co-morbidities, age, and gender. the music therapy group will utilize a certified music therapist to provide live music based on the patient's cultural preferences and entrainment. the primary outcome is a reduction in mechanical ventilation hours of 35% compared to the control group. secondary outcomes include: amount of sedation, richmond agitation-sedation scale (rass), delirium and pain score, icu and hospital length of stay. the researchers hypothesize that live entrained music therapy compared to control will result in a reduction in the time of extubation, amount of sedation administered, icu and hospital length of stay.

Eligibility criteria:
inclusion criteria: * adult patients with acute hypoxemic respiratory failure, acute hypercapnic respiratory failure, and ards admitted to the icu requiring mechanical ventilation * patients that are anticipated to remain on invasive mechanical ventilation for 48 hours or more will be screened for participation in the study exclusion criteria: * under 18 years of age * identified hearing disorder * prior history of chronic respiratory failure requiring mechanical ventilation * rass score of -4, or -5 * active seizures, or status epilepticus * cardiac arrest * coma * end of life * more than 2 vasopressors

Keywords: music therapy song of kin music medicine
normal polysomnography values in healthy children and adolescents in china

Conditions: Sleep Apnea

Summary: the study is designed to investigate normal polysomnographic respiratory values of chinese healthy children and adolescents. by collecting the polysomnography (psg) data and parameters of respiratory and sleep architecture，we hope to characterize normal polysomnography values in chinese children and adolescents and to establish respiratory reference values for pediatric polysomnography which based on chinese children's data.

we plan to recruit 200 healthy, normal children and adolescents in this study, age ranging from 3 to 15 years. all of them will be invited to undergo an overnight polysomnography for at least 7h in beijing children's sleep center, meanwhile the parameters about sleep including eeg, electromyography, electrooculography, ecg, pulse oximetry arterial oxygen saturation (spo2), chest wall and abdomen motion, oral and nasal airflow, and end-tidal pco2 (petco2) will be recorded. based on the data we hope to give recommendation of normal psg parameters of chinese kids, and on this basis,to develop the diagnosis creteria for obstructive sleep apnea syndrome which will be more suitable for chinese children conditions.

Eligibility criteria:
inclusion criteria: 1.3 to 14-year-old children 2.from the community of china 3.healty children exclusion criteria: 1. children with nocturnal snoring, continuous mouth breathing, difficulty breathing and apnea when sleep. 2. children with craniofacial abnormalities, such as down's syndrome, crouzon syndrome, achondroplasia, mandibular hypoplasia and facial mandibularetc hypoplasia. 3. children with history of upper respiratory tract infection nearly two weeks. 4. children with adenoids, tonsils, throat, glottis, trachea, lungs and history of thoracic surgery. 5. children with nose-sinusitis, allergic rhinitis, asthma, acut or purulent tonsillitis acute phase. 6. children with any medical or surgicaldiseases. 7. children who have to use use sedation to maintain sleep. 8. parents or child not understand the study or do not agree to take part in.

Keywords: children polysomnography sleep obstructive sleep apnea; chinese
health coaching for back pain after emergency department discharge

Conditions: Low Back Pain

Summary: the goal of this two-group randomized trial is to determine the feasibility and acceptability of a remotely-delivered health coaching intervention offered in conjunction with usual care for patients with an acute exacerbation of chronic low back pain who present to the emergency department (ed). the main questions this feasibility trial aims to answer are: * is our health coaching intervention and randomized trial methodology feasible to conduct? * is our health coaching intervention acceptable to participants and ed providers? participants will be randomized to one of two groups (usual ed care plus health coaching or usual ed care plus education) and complete outcome assessments at 3 and 6 months after ed discharge. participants and ed providers will also complete an interview.

this study is a two-group randomized feasibility trial of usual ed care plus either remote health coaching or remote education in patients with acute exacerbation of chronic low back pain presenting to the ed. we hypothesize that our health coaching intervention and randomized trial methodology will be feasible and that our health coaching intervention will be acceptable to participants and ed providers. forty participants will be randomized (20 per group), with 36 (90%) retained in the trial up to 6 months follow-up. eligible patients presenting to the ed with a chief complaint of acute exacerbation of chronic low back pain will be randomized. patients will be enrolled during or shortly after their ed visit, asked to complete a baseline questionnaire, and then randomized. randomized participants will receive 8 calls from either a health coach or education provider, and be asked to complete assessments at 3 and 6 months after ed discharge. interviews will be conducted with randomized participants and 15 ed providers asking about their experience with the intervention.

Eligibility criteria:
inclusion criteria: 1. chief complaint of musculoskeletal lbp 2. meets nih-supported chronic lbp criterion (e.g., pain greater than 3 months that has resulted in pain on at least half the days in the past 6 months) 3. age 18 years of age or older 4. english-speaking exclusion criteria: 1. requires hospitalization for an acute medical condition or active comorbidity 2. in the opinion of the investigator has a severe psychiatric or behavioral diagnosis or substance use disorder that would interfere with the ability to perform the intervention and complete follow-up 3. involved in litigation related to the lbp condition
safety and efficacy of libigel® for the treatment of hypoactive sexual desire disorder in surgically menopausal women

Conditions: Hypoactive Sexual Desire Disorder

Summary: this study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of libigel® 300mcg in the treatment of hsdd in surgically menopausal women


Eligibility criteria:
inclusion criteria: * must be between the ages of 30 to 65 years * must have undergone hysterectomy and bilateral salpingo-oophorectomy exclusion criteria: * a history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation * any systemic skin diseases or local skin abnormalities in the area of application * diagnosed with another primary female sexual dysfunction (e.g., sexual aversion disorder, female sexual arousal disorder). * a medical condition that could affect or interfere with sexual function * using a systemic topical gel or cream estrogen therapy.

Keywords: hypoactive sexual desire disorder testosterone menopause
efficacy and safety of synera in osteoarthritis pain

Conditions: Knee Osteoarthritis

Summary: knee osteoarthritis (oa) can result in significant pain and limitation of function. a number of topical non-steroidal anti-inflammatory drugs have been shown to reduce pain in this condition. this study examines a different topical approach, utilizing a topical anesthetic agent, to evaluate if application of such an agent would provide relief of exercise-induced knee pain in people with knee oa.

subjects participated in two visits each at least 1 week apart, where they underwent two exercise interventions - a baseline exercise without treatment and a experimental exercise with intervention (synera patch or inactive patch). participants rated their pain on a nrs-11 1 minute, 5 minutes, and 60 minutes after both exercises, as well as 6 hours after the experimental exercise, before bedtime, and the following morning. subjects were randomized to receive either synera at the first visit and the inactive patch at the second visit or the inactive patch at the first visit and synera patch at the second visit.

Eligibility criteria:
inclusion criteria: 1. men and women, age 40 years and above 2. meet american college of rheumatology criteria for knee oa 3. knee pain most days of the week for the past month 4. knee pain \> 5/10 after exercise intervention 5. capable of undertaking exercise intervention 6. stable cardiovascular function 7. able to return for all clinic visits 8. able to read and understand the informed consent document exclusion criteria: 1. use of a walker to ambulate or inability to ambulate 2. other forms of arthritis 3. other major causes of pain that could be expected to interfere with assessment of pain during this trial, e.g., recurrent migraine, back pain, fibromyalgia 4. history of myocardial infarction 5. blood pressure \> 140 systolic/100 diastolic 6. scheduled for and likely to need joint replacement surgery in the next 3 months 7. any medical condition that in the judgment of the investigator would make the participant not suitable for the study 8. sensitivity to lidocaine, topical or injectable analgesics/anesthetics.
determinants of neonatal anemia in women carrying multiples

Conditions: Anemia

Summary: multiple births in the united states are rapidly increasing in large part due to assisted reproductive technologies. recent data indicate that multiple births now comprise 3-4.5% of all births in the united states. pregnant women are at risk for iron (fe) deficiency anemia yet there are virtually no data on fe status in women carrying multiples and current recommendations do not necessitate fe screening among this high risk group. maternal anemia is known to increase the risk of adverse birth outcomes including preterm birth and low birth weight. moreover, the developing brain is increasingly recognized to be susceptible to fe insufficiency in utero and growing data support that suboptimal fe stores at birth are associated with long-term irreversible cognitive deficits in the offspring. to address these gaps in knowledge the investigators will monitor weight gain, hematological measures, fe status indicators and serum hepcidin across pregnancy in approximately 120 women carrying twins and triplets. determinants of maternal anemia will be identified. neonatal hematological measures will be assessed in cord blood from each neonate at birth for assessment of hematological measures, fe status and hepcidin. determinants of neonatal anemia will be identified. inflammatory markers will be measured in all blood samples and related to outcomes. stable iron isotopes will be given to a subset of women to assess maternal fe absorption and fetal fe uptake.

pregnant women (n=100-125) carrying multiples (twins and triplets) will be identified when entering prenatal care. women will be invited to participate in a longitudinal study of fe homeostasis across pregnancy and at delivery in the maternal / neonatal dyad. in all maternal and cord blood samples obtained, whole blood will be analyzed for hemoglobin, hematocrit, reticulocyte count, erythrocyte count, mean corpuscular hemoglobin, mean corpuscular hb concentration, mean corpuscular volume, and red cell distribution width using standard procedures. circulating fe status indicators (serum iron, ferritin, c-reactive protein, il-6, erythropoietin, transferrin receptor and hepcidin) and serum folate and vitamin b12 will be measured. distributions of each variable will be examined and associations among variables will be explored. multiple linear regression models will be constructed to examine specific relations between a) determinants of fe deficiency anemia in the mother; b) fe status indicators in the mother vs. those in the neonate; c) fe status indicators in the mother and neonate with placental fe binding proteins; and d) neonatal fe status between siblings.

Eligibility criteria:
inclusion criteria: * the investigators anticipate that the majority of these women will be recruited early in gestation because many of these pregnancies are a result of assisted reproductive technology. * eligible volunteers will be otherwise healthy and have no diagnosed, preexisting medical conditions known to impact iron homeostasis exclusion criteria: * hemoglobinopathies, * preexisting diabetes, * malabsorption diseases