Kornimate/medical-research-clean huggingface dataset:
adjuvanted influenza vaccination year 2 follow-on survey

Conditions: Influenza; Influenza-like Illness; Influenza, Human

Summary: the purpose of this study is to determine if different influenza vaccines produce different outcomes in nursing facility residents receiving the required annual influenza vaccination.

this study will enroll facilities who participated in the adjuvanted influenza vaccine study in 2016-2017 to document the vaccine choice for the 2017-2018 influenza season through a survey. additional facilities will be enrolled that did not participate to answer a survey responding to questions regarding the vaccine choice for the 2017-2018 and 2018-2019 flu season. both groups will also gather information on vaccination rates for residents and staff, policies and procedures, and influenza outbreaks. the facility will complete a profile and answer questions regarding influenza vaccination in their facilities for the 2017-2018 and 2018-2019 flu seasons. the study team will obtain data from the centers for medicare \& medicaid services in 2019 to determine the study outcomes. none of the data used in the analysis will be linked to individual residents in facilities.

Eligibility criteria:
inclusion criteria: * participated in the adjuvanted influenza vaccination and morbidity and mortality in u.s. nursing homes study * or * long-term care facilities within 75 miles of one of the 121 cities that serve as cdc surveillance sites exclusion criteria: * facilities having fewer than 50 long-stay residents * hospital based facilities * facilities with more than 20% of the population under age 65 * facilities not submitting minimum data set (mds) data

Keywords: influenza vaccine vaccination nursing home respiratory-related hospitalizations
family connections

Conditions: Chronic Respiratory Failure

Summary: this study seeks to evaluate a structured family deliberation that will serve as the primary intervention in a multicenter controlled trial involving families considering tracheostomy and home ventilation for the child. in this study, the investigators will evaluate the feasibility, usefulness, face validity, and preliminary impact of this approach on preparedness for decision making among participants.

the investigators will recruit 10 intervention families and 5 control families who are currently admitted to the neonatal or pediatric intensive unit and whose physician anticipates a decision about home ventilation within the next 30 days. intervention families will receive the structured family deliberation, which includes a guided review of a web-based decisional aid. control families will receive a link to the website for independent review. all families will be assessed at 1 month with a survey assessing preparedness for decision-making, parental stress and coping, and a qualitative interview.

Eligibility criteria:
inclusion criteria: * parents/legal guardians of children admitted to the neonatal or pediatric intensive care unit and whose physician anticipates a decision about home ventilation within the next month. exclusion criteria: * parents will be excluded if: * their child is in foster care or state guardianship * they are unable to understand the purpose of the study * they cannot reasonably participate in study demands * are not fluent in english (the web-based decisional aid is not yet available in other languages).

Keywords: tracheostomy home mechanical ventilation children with medical complexity medical ethics qualitative research
ecopipam tablets to study tourette syndrome in children and adolescents - open label extension

Conditions: Tourette Syndrome in Children; Tourette Syndrome in Adolescence

Summary: this study was an international, multicenter, open-label, long term extension study evaluating the safety of ecopipam tablets for the treatment of children and adolescent subjects with tourette syndrome.

this was an international, multicenter, open-label, long term extension study to evaluate the safety of ecopipam tablets for the treatment of pediatric subjects (aged ≥6 to ≤18 years at baseline) with tourette syndrome. participants who completed the phase 2b, randomized, double-blind, efficacy and safety study (ebs-101-cl-001) without major reportable protocol deviations, and who met all the inclusion/exclusion criteria for this study were eligible to participate in this study. all participants were titrated to a target dose of 2 mg/kg/day as participants rolled over from the phase 2b double-blind efficacy and safety study were tapered off study drug to maintain the blind from that study. participants were to complete study visits every month for 1 year. follow-up visits were conducted 7 and 14 days after the last dose of the study drug and a follow-up phone call was conducted 30 days after the last dose of study drug

Eligibility criteria:
inclusion criteria: * subjects must have completed the ebs-101-cl-001 study through the day 14 follow up visit within the last 30 days (or longer with permission of the medical monitor) without a major reportable protocol deviation and must be someone the investigator feels would benefit from continued participation. exclusion criteria: * certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder). * unstable medical illness or clinically significant lab abnormalities. * risk of suicide. * pregnant or lactating women. * moderate to severe renal insufficiency. * positive urine drug screen. * certain medications that would lead to drug interactions.

Keywords: tourette syndrome
study on the effect of bile reflux on gastric cancer and its precancerous lesions: a cross-sectional study.

Conditions: Bile Reflux Gastritis; Gastric Cancer; Helicobacter Pylori Infection; Intestinal Metaplasia; Precancerous Lesions

Summary: to explore the effects of bile reflux on gastric cancer and its precancerous lesions, so as to better prevent the occurrence and development of gastric cancer.

this study was a multicenter cross-sectional study. patients were consecutively enrolled and divided into gastric cancer group, gastric precancerous lesions group, and chronic gastritis group, according to histopathological results. the bile reflux detection rate and helicobacter pylori infection status were recorded for each group.

Eligibility criteria:
inclusion criteria: 1. age 18 to 75 years old, gender is not limited; 2. patients with upper abdominal pain, abdominal distension, belching, anorexia, early satiety, hiccup, acid reflux, upper abdomen burning sensation and other upper gastrointestinal symptoms; 3. voluntary acceptance of hp testing; 4. voluntary acceptance of the endoscopy and pathological biopsy. exclusion criteria: 1. had undergone upper gastrointestinal surgery; 2. previous diagnosis of esophageal cancer; 3. previous diagnosis of gastric cancer; 4. previous diagnosis of malt lymphoma; 5. pregnant and lactating women; 6. those with mental disorders; 7. refusal to sign the informed consent form.

Keywords: gastric cancer; helicobacter pylori; precancerous lesion; bile reflux
corticosteroid injection effectiveness in carpel tunnel patients with negative or mild emg studies

Conditions: Carpal Tunnel Syndrome

Summary: carpal tunnel syndrome (cts) is the most common nerve entrapment syndrome worldwide. there are currently no studies examining the effectiveness of corticosteroid injections in patients with normal (negative) emg studies. the purpose of this study is to gain a better understanding of the duration of symptom improvement post corticosteroid injection in patients with negative or mild emg studies. the boston carpal tunnel questionnaire will be given to patients undergoing corticosteroid injections for the treatment of carpal tunnel syndrome to assess their response to the injection. investigators will collect data retrospectively. the boston carpal tunnel questionnaire (bctq) is administered as per standard protocol to all patients with cts who have a negative or mild emg study. the bctq assesses the patient's self-reported symptom severity and functional status. investigators will analyze this data with respect to demographics as well as numbness in the median n. distribution, nocturnal numbness, weakness/atrophy of the thenar musculature, tinel's sign, phalen's test, loss of 2-point discrimination, quick-dash score, and grip strength score. the primary outcome will be the boston carpal tunnel questionnaire outcome score under the different emg conditions.the secondary outcomes will be numbness in the median n. distribution, nocturnal numbness, weakness/atrophy of the thenar musculature, tinel's sign, phalen's test, loss of 2-point discrimination, quickdash score, and grip strength score. both outcomes will be examined in patients with negative or mild emg readings. this information will allow orthopedic physicians to gain a better understanding of the duration of symptom improvement post-corticosteroid injection, allowing them to fine tune their treatment plans for cts patients.


Eligibility criteria:
inclusion criteria: * patients who speak english * patients who are 18 years or older * patients who are clinically diagnosed with cts * patients who have a negative or mild emg study * patients who receive a corticosteroid injection after obtaining a negative or mild emg study exclusion criteria: * patients who do not speak english * patients who are younger than 18 years of age * patients who have experienced previous trauma to the wrist * patients who have had previous treatment for cts including but not limited to corticosteroid injection or surgery * patients with a moderate or severe emg study

Keywords: corticosteroid injection electromyography
hormonal regulation of postpartum weight and presence of gut peptides in human milk

Conditions: Maternal Obesity Syndrome

Summary: hormonal regulation of postpartum weight and presence of gut peptides in human milk studies suggest that childbearing is an important contributor to the development of obesity in many women and that breastfeeding may be protective. ghrelin and peptide yy (pyy) are gut hormones involved in appetite regulation and energy homeostasis and are biological neuroendocrine signals that potentially affect body weight and adiposity/

role of ghrelin and pyy in postpartum body weight regulation and presence in human milk. this study evaluated whether fasting or postprandial ghrelin or pyy is different between lactating and nonlactating postpartum women matched for age, body weight, and adiposity. eligibility criteria: healthy females, 18+ years old, non-smokers, no major food allergies, first-time mom, currently pregnant or within 1 month of giving birth.

Eligibility criteria:
inclusion criteria: * healthy women (non-smokers) at least 18 years old who did not have any pregnancy complications, and gave birth to their first child within one month. * the study is open to women who are breastfeeding or formula feeding. exclusion criteria: * smoker, * had twins or triples, * had any major complication of pregnancy(example, * gestational diabetes); * have kidney, liver, hormonal, stomach, intestine,lung, heart or blood disease. this also includes high blood pressure; * use prescription or over-the-counter medicine or herbal drinks or pills. * history of depression, anxiety, disordered eating, other psychological problems, alcoholism or other substance abuse. * severely claustrophobic. * having a strong fear of needles and/or do not feel you can have blood drawn every 30 minutes from a plastic catheter. * are not able to or willing to fully participate in the study, and are pregnant, anemic or have a thyroid problem.

Keywords: human milk, ghrelin,pyy and maternal obesity.
study of azd8931 in patients with advanced solid malignancies

Conditions: Advanced Solid Malignancies

Summary: the main purpose of this study is to explore the safety and tolerability of multiple ascending doses (mad) of azd8931 in patients with advanced solid malignancies


Eligibility criteria:
inclusion criteria: * cancer which is refractory to standard therapies, or for which no standard therapies exist. inclusion is irrespective of stage of disease or extent of prior therapy. * histologically or cytologically confirmed solid, malignant tumour. exclusion criteria: * receipt of any of the following treatments within 4 weeks prior to study entry: chemotherapy (within 6 weeks for nitrosurea or mitomycin c), radiotherapy, hormone therapy (except for androgen-deprivation therapy for patients with prostate cancer), immunotherapy and any other anti-cancer therapies. * unresolved toxicity (other than stable toxicity) from previous anti-cancer therapy, except alopecia. * history of documented cardiac failure, angina pectoris requiring antianginal medication, evidence of transmural infarction on ecg, poorly controlled hypertension (systolic \>180 mmhg or diastolic \>100 mmhg), significant valvular disease or history of high risk dysrrhythmia (such as ventricular fibrillation or ventricular tachycardia \[includes ventricular triplets\]). * resting ecg with measurable qtc interval of \> 460 msec at 2 or more time-points within a 24-hour time period, or history of prolonged qtc syndrome. * the presence of any ocular disease or condition that is active or is likely to flare up during the course of the study or any systemic disease/condition that is affecting or has affected the eye in the past and may flare up, or the treatment of which may have an adverse effect on the eye. eye conditions that are stable and of long standing, such as scars from trauma, pinguecula, atrophic pterygia etc, should not be considered as reasons to exclude the patient.

Keywords: advanced cancer solid tumour solid malignancies neoplasms
safety study of 90y-hmn14 to treat pancreatic cancer

Conditions: Pancreatic Neoplasms

Summary: the purpose of this trial is to determine the safety of 90y-hmn14 at different dose levels in the treatment of pancreatic cancer.


Eligibility criteria:
disease characteristics: * patients with a documented histologic or cytologic diagnosis of a pancreatic malignancy * patients with recurrent, advanced and/or metastatic disease, who have either failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority. * patients with at least one identified (confirmed) and measureable tumor site. prior/concurrent therapy: * surgery: patients are excluded if they have had major surgery either during or within four weeks prior to study entry. * chemotherapy: patients must have failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority. * biologic therapy: patients who have received a chimeric, cdr-grafted (humanized), or human igg will be eligible provided pre-study evaluations demonstrate no significant reactivity with hmn14 igg (i.e., haha) * radiotherapy: no prior radiotherapy within four weeks of study entry. no prior external beam irradiation to a field that includes more than 30% of the red marrow. no prior radiation to maximal tolerable levels for any critical organ (e.g., 3,000 cgy for the liver; 2,000 cgy for the lungs and kidneys). * other: any experimental therapy (i.e., drugs, biologics, procedures) for the primary malignancy, either during or within four weeks prior to study entry. patient characteristics/inclusion criteria: * performance status: patients with a karnofsky performance status \> 70% (or equivalent, ecog 0-1) and an expected survival rate of at least 3 months * hematopoietic: hemoglobin \> 10g/dl; wbc \> 3000 per mm3; granulocyte count \> 1500 per mm3; platelet count \> 100,000 per mm3 * hepatic: total bilirubin \< 1.5 times the institutional upper limit of normal (iuln); ast or alt \< 2 x iuln * renal: creatinine \< iuln * cardiovascular: patients with lvef \>/= 50% by required muga/2d-echo study * pulmonary: patients with df and fev1 \>/= 60 % by required pulmonary function tests * gastrointestinal:patients with severe anorexia or other related symptomology are excluded * central nervous system: patient with known metastatic disease to the cns are excluded * other: patients who have had a prior imaging study with a murine antibody may be included. patients agreeing to use a medically effective method of contraception during and for a period of three months after the treatment period. a pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into the study. patients able to understand and give written informed consent.

Keywords: pancreatic cancer pancreatic carcinoma pancreatic neoplasms pancreas cancer pancreatic tumor
multicenter, open, randomized comparative trial to compare the efficacy of azithromycin versus amoxicillin in children with strep throat

Conditions: Tonsillitis

Summary: the primary objective was to compare the bacteriological efficacy at day 10 of azithromycin pediatric suspension (20 mg/kg/day once daily for 3 consecutive days) versus amoxicillin pediatric suspension (50 mg/kg/day in 2 doses for 6 consecutive days) in children aged 3-15 years with group a streptococcal acute pharyngitis/tonsillitis. secondary objectives were assessments of bacteriological efficacy at day 30 and clinical efficacy at day 10 and day 30.


Eligibility criteria:
inclusion criteria: outpatients with an acute pharyngitis erythematous or erythematopultaceous with modification of pharynx aspect and fever of ≥38° c, and patients either with or without spontaneous pharyngeal pain or upon swallowing and enlargement of the cervical lymph node (mandibular area) were eligible for inclusion. all subjects should have had a positive rapid strep test and a positive culture for group a beta-hemolytic streptococcus. exclusion criteria: patients with pseudomembranous, vesicular, ulcerous or ulceronecrotic pharyngitis were excluded.
the effect of insect protein on performance and hypertrophy

Conditions: Protein Supplementation

Summary: purpose: to study the effect of insect protein on performance and hypertrophy during 8 weeks of resistance training. hypothesis: insect protein supplementation enhances the effect of resistance training on muscle mass and muscle strength. primary outcome: muscle hypertrophy and muscle strength design: two groups of healthy young men (age: 18-30 years) with resistance training experience, but no structural resistance training performed for the last 12 months. randomized controlled intervention study +/- insect protein (placebo group ingest isocaloric carbohydrate). both groups perform 8 weeks of progressive resistance training (4/week) aiming to induce muscle hypertrophy.


Eligibility criteria:
inclusion criteria: * healthy young men (age: 18-30 years) with experience in resistance training * 2 hours of physical exercise per week or more exclusion criteria: * no structural resistance training for the last 12 months * no injuries * no smoking * no ingesting of protein or creating supplementations * no use of medicine which may influence the adaptation to strength training
transurethral versus percutaneous endoscopic management of bladder stones in boys

Conditions: Pediatric Bladder Stones

Summary: to compare safety and efficacy of trans urethral and per cutaneous approaches in endoscopic management of bladder stones in boys younger than 14 years

pediatric urolithiasis remains endemic in developing nations, affecting children at ages less than 1 year to adolescence. the prevalence rate is high at 5% to 15% compared with 1% to 5% in developed countries. recent studies have shown that the percentage of bladder stones in pediatric urolithiasis is 30%. open cystolithotomy has been the traditional modality to treat bladder stones. it has the inherent problems of a long scar, prolonged catheterization and hospitalization and risk of wound infection .the advent of improved endoscopic techniques in the form of gradual decrease in endoscopic sizes and the development of effective lithotripters have made trans urethral endoscopic management of bladder stones feasible. excellent stone-free rates with trans urethral lithotripsy with minimal complications make it a preferred treatment option . however, in children especially boys, the small caliber of urethra raise concerns about the ability of stone fragments clearance and the possibility of iatrogenic urethral stricture occurrence. this renders trans urethral cystolithotripsy to be more difficult and unfavorable . per cutaneous cystolithotomy (pccl) can be a safe alternative with low morbidity and complication rate. it has been performed safely for bladder stones up to 5 cm in size. this procedure may carry many advantages in the form of short operative time, more feasible stone fragments retrieval and less need for stone disintegration with its possible sequel as mucosal perforation or stone escaping inside the bladder that prolong the operative time. on the other hand pccl has important disadvantages such as the presence of an incision, the need to dilate a tract and the potential need for a urethral catheter or supra pubic tube. there are other reported complications including paralytic ileus, abdominal distention from escape of irrigating fluid into the abdominal cavity and urine leakage. it also carries a risk of bowel injury especially if there is a history of abdominal or pelvic surgery. to the best of our knowledge, no previous prospective studies compared between per cutaneous and trans urethral approaches for endoscopic management of bladder stones in male children. the aim of the study is to compare safety and efficacy of trans urethral and per cutaneous approaches in endoscopic management of bladder stones in boys younger than 14 years.

Eligibility criteria:
inclusion criteria: * boys less than 14 yrs old age with bladder or urethral stones less than 3 cm. exclusion criteria: * neurogenic bladder. augmented bladder. upper urinary tract stones that needs simultaneous ureteroscopy, pnl or ureteral stent insertion. bleeding tendency. urethral stricture. stone in fossa navicularis that can be extracted after meatotomy.