Kornimate/medical-research-clean huggingface dataset:
trial of afatinib in pediatric tumours

Conditions: Neuroectodermal Tumors; Rhabdomyosarcoma

Summary: open-label, dose escalation, monotherapy, basket trial with biomarker specific mtd expansion cohort/phase ii part. the trial will consist of 2 parts: 1. dose finding part to determine the mtd 2. biomarker specific mtd expansion cohort/phase ii part to assess clinical anti-tumour activity in included tumour types


Eligibility criteria:
inclusion criteria: * paediatric patients aged 1 year to \<18 years at the time of informed consent * diagnosis of hgg, dipg, low grade astrocytoma, medulloblastoma/pnet, ependymoma, neuroblastoma, rms and tumours with erbb deregulation * recurrent/refractory disease after they received at least one prior standard treatment regimen * no effective conventional therapy exists * performance status \>= 50% (lansky for =\ 12ys) * further inclusion criteria apply exclusion criteria: * relevant toxicity from previous treatment * known pre-existing relevant cardiac , hepatic, renal, bone marrow dysfunction, ild, keratitis * further exclusion criteria apply
the diagnostic experience of male rett syndrome

Conditions: Rett Syndrome; RTT

Summary: the diagnostic experience of male rett syndrome collects information on the lived experiences of parents or caregivers to boys with rett syndrome. key information examined includes the process of getting a male rett syndrome diagnosis, your son's systems of care, and your priorities for his health needs. enrolled participants will complete an online survey with questions about having a son with rett syndrome. the diagnostic experience of male rett syndrome study is available to parents or caregivers to boys (alive or passed) with rett syndrome. compensation is not provided.


Eligibility criteria:
inclusion criteria: * english-speaking parents (over the age of 18) of male children (all ages, alive or deceased) with confirmed genetic diagnosis of male rtt exclusion criteria: * parents of male mecp2 duplication syndrome
is aminophylline more effective than neostigmine/atropine mixture in the treatment of post-dural puncture headache

Conditions: Post-Dural Puncture Headache

Summary: objectives: to compare the safety and efficacy of iv aminophylline versus iv neostigmine/atropine mixture in the treatment of post-dural puncture headache (pdph). background: pdph is the most frequent complication of procedures associated with dural puncture for spinal anesthesia or following accidental dural puncture during epidural anesthesia. since invasive treatments have known complications, pharmacologic management may be preferable. patients and methods: this was a prospective, randomized, double-blind, phase four clinical trial; carried out on 60 patients presented with pdph at our hospital. patients were randomly allocated into two equal groups (30 patients each); group a, received iv aminophylline, and group na, received iv neostigmine/atropine mixture.


Eligibility criteria:
inclusion criteria: * patients with nprs score of ≥ 5 * american society of anesthesiologists (asa) physical status ≤ ii * age from 21 to 50 years exclusion criteria: * patients with nprs score \< 5 * asa physical status \> ii * age \ 50 years * pregnant women * history of; chronic headache, cluster headache, migraine * history of; convulsions, cerebrovascular accident, previous neurological diseases * signs of meningismus * bronchial asthma * arrhythmia * hypertension * ischemic heart disease * hyperthyroidism

Keywords: aminophylline atropine neostigmine post-dural puncture headache spinal anesthesia
environmental exposure to lead and its health effects on patients with maintenance hemodialysis

Conditions: Anemia; Malnutrition; Inflammation; Lead Poisoning

Summary: one thousand patients with lhd who have no history of exposure to lead will be observed for 18 months. blood lead level(bll), biochemical data, hemoglobin, albumin, cr, high sensitivity c-reactive protein (hscrp), and blood cell counts are assessed at baseline. the morbidity and mortality are recorded in detail. then, one hundred subjects with high bll (\>20μg/dl) will be randomly assigned to the study and control groups. for 3-6 months, the 50 patients in the study group will receive lead-chelation therapy with calcium disodium edta weekly until the blb falls below bll\ 10 μg/dl, the chelation therapy will be performed again until their bll is \<5 μg/dl. the primary end point is morbidity or mortality during the observation and follow-up period. a secondary end point is the change in hemoglobin, albumin, cr and hs crp during the follow up period.


Eligibility criteria:
inclusion criteria: * mhd patients have dialyzed for more than 6 months and age \>18 and \< 90 year-old exclusion criteria: * patients with malignancies and obvious infectious diseases as well as those who are hospitalized or underwent surgery or renal transplantation within the 3 months preceding the investigation;patients with a history of occupational exposure to heavy metals, metal intoxication, living in metal-contaminated areas were also excluded.

Keywords: environmental lead exposure, maintenance hemodialysis; blood lead levels, edta chelating agents, malnutrition, anemia, inflammation, mortality. to determine whether lead chelation therapy improves the anemia, malnutrition, inflammation, morbidity or mortality in hemodialysis patients.
study of chemoimmunotherapy for high-risk neuroblastoma

Conditions: Neuroblastoma (NB)

Summary: the purpose of this study is to find out whether an experimental drug called hu3f8 can be given with the chemotherapy drugs irinotecan and temozolomide and another drug called gm-csf. the investigators want to find out if this combination is safe and what effect it has on the participant and the disease.


Eligibility criteria:
inclusion criteria: * diagnosis of nb as defined by international criteria,.e., histopathology (confirmed by the msk department of pathology) or bone marrow metastases plus high urine catecholamine levels * high-risk nb as defined as any of the following: * stage 4 with mycn amplification (any age) * stage 4 without mycn amplification (\>1.5 years of age) * stage 3 with mycn amplification (unresectable; any age) * stage 4s with mycn amplification (any age) * patients fulfill one of the following criteria: 1. have evidence of soft tissue disease or 2. if they only have osteomedullary disease at protocol enrollment, they should have: * had previously received hu3f8+gmcsf therapy and have had less than a complete response to it or * had progressed progressive disease after their most recent anti-neuroblastoma therapeutic regimen * patients must have evaluable (microscopic marrow metastasis, elevated tumor markers, positive mibg or pet scans) or measurable (ct, mri) disease documented after completion of prior systemic therapy. * prior treatment with murine and hu3f8 is allowed. * prior treatment with irinotecan or temozolomide is permitted. * patients with prior m3f8, hu3f8, ch14.18 or hu14.18 treatment must have a negative haha antibody titer. human anti-mouse antibody positivity is allowed. * signed informed consent indicating awareness of the investigational nature of this program. exclusion criteria: * patients with cr/vgpr disease * existing severe major organ dysfunction, i.e., renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity ≥ grade 3 except for hearing loss, alopecia, anorexia, nausea, and hypomagnesemia from tpn, which may be grade 3 * anc \< 500/ul * platelet count \<30k/ul * history of allergy to mouse proteins * active life-threatening infection * inability to comply with protocol requirements * women who are pregnant or breast-feeding

Keywords: hu3f8 irinotecan temozolomide sargramostim chemoimmunotherapy 17-251
rehabilitation in the home setting for older adults in the early period after myocardial infarction

Conditions: Acute Myocardial Infarction (AMI)

Summary: this pilot feasibility study will test whether a home-based cardiac rehabilitation intervention, using physical therapist visits combined with mobile health technology, will prevent decline in high-risk patients post acute myocardial infarction (ami). participants will be randomized to either an intervention arm (home-based physical therapy), or a control (usual care) arm. prior to discharge, participants in the intervention arm will receive a 1-hour educational session by a research physical therapist that includes information on cardiac risk factor management, postoperative recovery, education on medication adherence, and a prescription for home exercise that is tailored to each patient's baseline abilities and limitations. participants assigned to the control arm will receive a 30-minute counseling session on risk factor modification prior to discharge, in addition to usual care post-ami.

all participants enrolled in this research study will receive the fda-approved fitbit flex, a wearable activity monitoring device which will objectively measure physical activity and sedentary behavior in the period post-hospital discharge. daily activity monitoring will include: number of steps, distance traveled, calories burned, number of active minutes.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute myocardial infarction (ami). exclusion criteria: * moderate to severe cognitive impairment; non-ambulatory * severe heart failure (nyha class iv); decisional impairment as assessed by the university of california * san diego brief assessment of capacity to consent (ubacc) 22, if the rc questions capacity; very limited life expectancy (e.g. anticipated discharge to hospice) * non-english/non-spanish speaking.
mp3 (microperimeter 3) reproducibility in healthy subjects and macular patients

Conditions: Macular Degeneration

Summary: the aim of the present study is to investigate the reproducibility of the mp3 and to compare the results with conventional perimetry using the octopus 101 in healthy subjects and patients with macular disease.


Eligibility criteria:
inclusion criteria for healthy subjects * men and women aged 18 and older * written informed consent * normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant * normal ophthalmological findings unless the investigator considers an abnormality to be clinically irrelevant inclusion criteria for macular disease patients * men and women aged 18 and older * written informed consent * presence of a macular disease (such as dry or exudative age-related macular degeneration, diabetic maculopathy, epiretinal membrane) any of the following will exclude a subject from the study: * any opacities (corneal scar, dense cataract) which interferes with the study relevant measurements * visual acuity \< 0.1 (snellen)

Keywords: retina perimetry
dose ranging study of metronidazole vaginal gel in the treatment of bacterial vaginosis

Conditions: Vaginosis, Bacterial; Vaginal Infection

Summary: the objective of this study is to evaluate the efficacy and safety of gw05 administered in 3 regimens versus metronidazole 0.75% for the treatment of bacterial vaginosis.

this is a multicenter, randomized, investigator-blinded, phase 2, dose ranging study of gw05 vaginal gel administered in 3 regimens compared to metronidazole 0.75% (qd x 5 days) for the treatment of bacterial vaginosis. subjects will be evaluated at three timepoints (1 screening/baseline visit, post-treatment phone call and 1 test-of-cure visit). the total study duration may be up to 30 days for a subject. study medication will be applied intravaginally once daily at bedtime according to the assigned dosing schedule using the supplied 5-gram vaginal applicators. investigator blinding will be ensured by utilizing an independent drug dispensing coordinator at each site. bacterial vaginosis (bv) is an infection of the vagina (birth canal) that is the result of an overgrowth of bacteria that are often normally found in the vagina. this type of vaginal infection typically does not cause irritation. the most common complaint of patients who suffer from bv is a fishy-smelling vaginal discharge. the amount of vaginal discharge may or may not be increased above a normal discharge. the bad odor may get worse after sexual intercourse or during the menstrual period. bv is also strongly associated with problems during pregnancy, such as premature (early) birth, and with an increased risk of sexually transmitted diseases. therefore, it is important to treat the infection.

Eligibility criteria:
inclusion criteria: * females at least 18 years of age * in good general health * confirmed current diagnosis of bacterial vaginosis (determined at study screening) * negative pregnancy test (for women who are able to become pregnant) * must abstain from sexual intercourse throughout the first 7 days of thes study * must abstain from alcohol ingestion during the treatment period and for one day afterward * must not use intra-vaginal products for the duration of the study exclusion criteria: * pregnant, lactating, or planning to become pregnant during the study period * menstruating at the time of the diagnosis or anticipate the onset of menses during the treatment phase of the study * had a medical event within 90 days of the visit (e.g., stroke, heart attack, etc.) * received specific treatments/medications /therapy within the designated time period prior to study enrollment

Keywords: bacterial vaginosis vaginal infection vaginal discharge vaginal disease
effects of lentil consumption on post-prandial blood glucose and insulin

Conditions: Healthy

Summary: the purpose of this study is to assess the effects of consuming various lentil varieties in mixed-meals (containing either white rice or white potato) on post-prandial blood glucose and insulin as compared to white rice or white potato alone.

eligible participants will undergo a total of 6 study visits. during each visit, a fasted blood sample will be taken by fingerprick, and approximately 500µl of blood will be dripped into a collection tube. the participant will then consume a meal of either: white bread, white rice (or white potato), or white rice with lentils (or white potato with lentils). white bread will be consumed on the first study visit and the rest of the meals will take place in random order in the visits following. each meal will provide a total of 50g available carbohydrate. six more blood samples will be taken by fingerprick at 15, 30, 45, 60, 90 and 120 minutes after the beginning of the meal.

Eligibility criteria:
inclusion criteria: * healthy men and women * age 18-40 years * bmi 20-30 kg/m2 exclusion criteria: * tobacco use * pregnant or breastfeeding * fasting blood glucose ≥ 7.0 mmol/l * any major medical condition including a history of aids or hepatitis * medical or surgical event requiring hospitalization within 3 months of randomization * any medications except a stable dose (3 months) of oral contraceptives, blood pressure or statin medications * blood pressure \>140/90 mm hg * natural health products (nhps) used for glycemic control * probiotic supplements * dietary fibre supplements * consumption of \>4 servings of pulses per week * food allergy or non-food life threatening allergy * shift workers * alcohol consumption \>14 drinks/week or \>4 drinks/sitting * recent or intended significant weight loss or gain (\>4 kg in previous 3 months) * elite athletes

Keywords: lentils post-prandial glycemic response insulin response diabetes mixed meal glycemia slowly digestible starch post-prandial glycemia
diagnostic value of prehospital eeg in non-convulsive status epilepticus

Conditions: Epilepsy; Status Epilepticus

Summary: a large proportion of patients (up to 20%) who suffer from an epileptic seizure and remain unconscious suffer from a non-convulsive epileptic seizure. the condition is difficult to diagnose, and impossible without the required instruments. electroencephalogram is required in the diagnosis of non-convulsive status epilepticus. presently, the diagnostic value and implementation of such a device in the prehospital field is little studied. the aim of this study is to evaluate the diagnostic value of the acquired electroencephalogram with a prototype eeg/ekg adapter connected to a physio-control lifepak 15 defibrillator/monitor. the eeg is registered in a otherwise normal fashion with scalp-electrodes, but only three channels are monitored, as this is deemed sufficient for the prehospital field, as well as for monitoring the epileptic seizures.


Eligibility criteria:
inclusion criteria: * unconsciousness due to seizures in the prehospital field exclusion criteria: * cardiac arrest * traumatic unconsciousness

Keywords: emergency care, prehospital coma electroencephalography
gastric-type endocervical adenocarcinoma: a population-based cohort study

Conditions: Uterine Cervical Neoplasms; Surgery; Therapy; Locally Advanced Cervical Carcinoma

Summary: this study aims to collect data of patients with gastric-type endocervical adenocarcinoma from the seer database, analyze the related prognostic factors and treatment patterns of gastric-type endocervical adenocarcinoma, and explore the impact of surgical treatment on the prognosis of locally advanced gastric-type endocervical adenocarcinoma.

this study aims to collect data of patients with gastric - type endocervical adenocarcinoma from the seer database, analyze the related prognostic factors and treatment patterns of patients with gastric - type endocervical adenocarcinoma, and explore the impact of surgical treatment on the prognosis of locally advanced gastric - type endocervical adenocarcinoma. study subjects: patients diagnosed with gastric - type endocervical adenocarcinoma were identified using the seer database and seer\*stat 8.4.2 software. the search scope was the "seer research plus data, 17 registries, nov 2021 sub (2000 - 2019)" database, and the screening criteria included "site and morphology, analytic behavior recode = malignant" and "site and morphology, icd - o - 3 / who 2008 recode site = cervix". patients with cervical gastric - type endocervical adenocarcinoma were selected from the database. outcome measures: overall survival (os): the time from diagnosis to death of the patient.

Eligibility criteria:
inclusion criteria: * patients diagnosed with gastric - type endocervical adenocarcinoma were identified using the seer database and seer\*stat 8.4.2 software. the search scope was the "seer research plus data, 17 registries, nov 2021 sub (2000 - 2019)" database. the screening criteria included "site and morphology, analytic behavior recode = malignant" and "site and morphology, icd - o - 3 / who 2008 recode site = cervix". patients with gastric - type endocervical adenocarcinoma in the database were selected. exclusion criteria: * patients with a survival time of 0 or unknown.

Keywords: uterine cervical neoplasms cervical cancer gastric - type mucinous adenocarcinoma surgery
maintenance infusion of oxytocin following elective cesarean deliveries

Conditions: Postpartum Hemorrhage

Summary: this study is designed to determine the minimal effective oxytocin maintenance dose required during cesarean delivery to achieve the best effect. oxytocin is a drug which is routinely used to help contract the uterus and keep it contracted after the delivery of the baby and placenta. the aim of oxytocin is to reduce the amount of blood that might be lost. in order to determine the minimal effective dose, the investigators will conduct a dose-finding study. the first patient will receive a set oxytocin infusion. if the uterus contracts well, this is considered satisfactory and the next patient will receive the same dose. if the uterus does not contract well, this is considered unsatisfactory and the next patient will receive a higher dose. the dose for the next patient will be determined based on the results of the uterine contraction of the previous patient. the investigators hypothesize that the ed90 of an oxytocin infusion rate to maintain a satisfactory uterine tone during a cesarean delivery in non-laboring women, would be lower than that found in previous studies without an initial bolus (less than 16 iu/h).

this study will be conducted as a prospective, double blinded clinical trial (patient, anesthesiologist and obstetrician blinded to the oxytocin dose), in an up-down sequential allocation fashion. the objective of the study is to determine the minimum effective dose of oxytocin infusion required to produce appropriate uterine contraction during and after cesarean delivery under neuraxial anesthesia in non-laboring women. for the purpose of this study, the minimum effective dose is defined to be that at which adequate response occurs in 90% of patients, i.e. ed90.

Eligibility criteria:
inclusion criteria: * elective uncomplicated cesarean delivery under neuraxial anesthesia * \>18 year-old with asa status ii or iii, with a singleton gestation and a gestational age between 37 to 42 weeks informed consent to participate in this study exclusion criteria: * refusal to give written informed consent * allergy or hypersensitivity to oxytocin * body mass index ≥ 40 kg/m2on the day of admission * a history of hypertension and/ or severe cardiac disease(s) * contra-indications for neuraxial anesthesia * conditions that predispose to uterine atony and postpartum hemorrhage such as placenta previa, multiple gestation, preeclampsia, macrosomia (≥ 4 kg), polyhydramnios, uterine fibroids in and near operating field, previous history of uterine atony and postpartum bleeding, or bleeding diathesis.

Keywords: cesarean delivery oxytocin uterotonic pregnancy
efficacy of laparoscopic sleeve gastrectomy and intensive medical management in obese type 2 diabetes

Conditions: Diabetes Mellitus; Obesity

Summary: in this the investigators will be comparing the effects of laparoscopic sleeve gastrectomy with intensive medical management on weight and metabolic parameters.

intensive medical management will include 1. vlcd 2. physical activity 3. exenatide 4. metformin 5. insulin detemir

Eligibility criteria:
inclusion criteria: type 2 diabetics with 1. bmi ≥ 27.5 kg/m2 2. hba1c 7-10% 3. age 20-70 years exclusion criteria: 1. prior gastric surgery 2. pregnancy and lactation 3. renal disease (gfr \< 60 ml/min) 4. pancreatitis 5. symptomatic gallstone disease 6. active malignancy 7. secondary causes of obesity ( cushing's syndrome, uncontrolled hypothyroidism) 8. severe psychiatric illness 9. allergic reaction to exenatide

Keywords: sleeve gastrectomy intensive medical management