Kornimate/medical-research-clean huggingface dataset:
human papilloma virus vaccine consistency and non-inferiority trial in young adult women with gsk bio hpv-16/18

Conditions: Infections, Papillomavirus

Summary: human papilloma virus (hpv) are viruses that cause a common infection of the skin and genitals in men and women. several types of hpv infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). this infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. if a woman is not infected by hpv, it is very unlikely that she will get cervical cancer. this study will evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of gsk biologicals hpv-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start. approximately 750 study subjects will receive different lots of the hpv vaccine administered intramuscularly according to a 0-1-6 month schedule.


Eligibility criteria:
inclusion criteria: * a woman between, and including, 10 and 25 years of age at the time of the first vaccination. * written informed consent from the subject prior to enrolment. * subject must be free of obvious health problems. * subject must have negative urine pregnancy test. exclusion criteria: * pregnant or breastfeeding. * known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality. * history of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease. * previous vaccination against human papillomavirus (hpv).
prevention recurrent otitis media in the young children

Conditions: Otitis Media

Summary: the purpose of this study is to find out if young children have more benefit of the combination of adenotomy and tympanostomy than plain tympanostomy in prevention of recurrent otitis media.

recurrent otitis media is the most common bacterial disease in young children. many risk factors are known, but benefit of operations are conflicting in children under two years of age. in this randomized prospective controlled trial, the effect of tympanostomy tubes is compared to the effect of the combination of adenotomy and tympanostomy tubes in preventing recurrent otitis media. a control group with no active treatment is also included. the speed of recovery is studied by recording the daily symptoms and number of days of effusion comparing the differences between the groups. life quality issues are recorded preoperatively and at about four and twelve months after the operation and are compared between the groups and to healthy children of the same age.

Eligibility criteria:
inclusion criteria: * at least 3 otitis media episodes during the last half year * address near (\< 50 km) the university hospital of oulu exclusion criteria: * otitis media effusion lasting longer than two months without acute exacerbations * prior adenoidectomy or tympanostomy * head or neck malformation * retarded child * serious disease * chemoprophylaxis for another disease

Keywords: recurrent otitis media adenoidectomy tympanostomy young children prevention quality of life
study of the steroid sparing effect of xolair (omalizumab) in patients with persistent eosinophilic bronchitis

Conditions: Steroid and/or Prednisone Dependent Asthma; Eosinophilic Bronchitis

Summary: the purpose of this study is to investigate whether addition of omalizumab enables a reduction in the dose of prednisone in patients with asthma and eosinophilic bronchitis. this will be a double-blind placebo-controlled, 3-centre, randomized parallel group trial divided into two sequential study periods. period 1: after establishing the minimum dose of prednisone to maintain asthma control and maintain sputum eosinophils \<3%, subjects will be randomized to either placebo or omalizumab for 16 weeks (either once monthly for 4 months or every 2 weeks for 4 months). period 2: standardised prednisone reduction at intervals of 4-weeks until there is a clinical and eosinophilic exacerbation or bothersome steroid withdrawal effects. if patients have an exacerbation, they will be treated with prednisone. this patient will continue on omalizumab or placebo during the entire duration of the study but not continue the phase of steroid reduction.


Eligibility criteria:
inclusion criteria 1. confirmed asthma within the past 2 years (12% bronchodilator reversibility or pc20 methacholine less than 8 mg/ml) 2. acq ≥1.5 and sputum eos ≥3% at the time of randomization 3. on ics (≥ 1500 mcg fluticasone propionate or equivalent) with or without additional prednisone 4. total serum ige ≥30 iu/l and positive allergy skin prick test 5. age between 18 and 75 years 6. ability to provide informed consent exclusion criteria 1. current smoker or ex-smokers with greater than 20 pack years 2. co-morbid diseases which in the investigator's opinion would make the patient unsuitable to participate in the study 3. currently on omalizumab or has previously been treated with omalizumab 4. currently on other biologic therapies (eg. prolia) 5. pregnancy or lactation 6. post bronchodilator fev1 less than 50% predicted

Keywords: prednisone eosinophils immunoglobin e (ige) asthma bronchitis inflammation allergy
multi-omics and ipscs to improve diagnosis of rare intellectual disabilities

Conditions: Rare Intellectual Disabilities

Summary: background genetic factors play a major role in intellectual disability (id) but the underlying cause is not determined in many cases. this proposal is the continuation of the previous interregional project hugodims, the aim of which was to perform whole exome sequencing (wes) in 69 thoroughly selected simplex id parent-child trios. thanks to hugodims consortium, the underlying genetic cause of id was determined or highly suspected in 48 cases (69.5%) and 7 novel id genes were identified. hypothesis investigators hypothesize that an approach combining genomics, transcriptomics, metabolomics and morphological analyses performed on induced pluripotent stem cell (ipsc)-derived neural cells would improve diagnosis of id. the current proposal is therefore a proof-of concept project aiming at assessing the relevance and effectiveness of this multi-omics approach. aims and methods ten individuals with id recruited through hugodims, in whom wes have failed to identify pathogenic variants will be included. the workflow is the following: 1. whole genome sequencing (wgs) (nantes) of these 10 negative trios. 2. bio-informatics analyses 3. in 3 wgs negative cases, 3 positive controls bearing distinct mutations in camk2a (a novel id gene identified thanks to hugodims), and 3 healthy negative controls: 1. derivation of induced pluripotent stem cell (ipsc)-derived neural progenitors (ipsc core facility at nantes) 2. targeted and non-targeted metabolomics analyses performed on ipsc-derived neuronal cells (angers) 3. rna sequencing performed on the 9 cell lines (rennes) 4. morphological analyses of differentiated neuronal cell lines derived from 3 affected individuals and 3 positive controls bearing cmk2a mutations (tours) 5. integration and validation of data from multi-omics and morphological approaches expected results and impact investigatrors expect that this approach combining multi-omics and ipsc will help to improve diagnosis and understanding of genetic id of unknown cause


Eligibility criteria:
inclusion criteria: * 3 whole genome sequencing negative cases * 3 positive controls bearing distinct mutations in camk2a exclusion criteria: * no informed consent/refusal
efficacy of irinotecan and capecitabine versus(vs) cisplatin and capecitabine in patients with esophago-gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to determine which arm (capecitabine + irinotecan versus capecitabine + cisplatin) shows higher response rates in the treatment of advanced gastric-oesophagal cancer furthermore, comparison of progression-free survival, 1-year survival, quality of life and safety

capecitabine + irinotecan versus capecitabine + cisplatin, as published by kang et al. (asco 2006)

Eligibility criteria:
inclusion criteria: * gastric or gastric-oesophagal junction adenocarcinoma * unidimensional measurable disease * karnofsky index \>/=60% exclusion criteria: * prior chemo- or radiotherapy * colorectal diseases * brain metastases

Keywords: cisplatin capecitabine gastric irinotecan metastatic chemotherapy
influence of pesf on oxygen saturation, quality of life and exercise capacity in copd

Conditions: COPD

Summary: the effect of pesf (pulsating electrostatic field) on the oxygen saturation, quality of life and the exercise capacity will be studied in a randomized, dubbel blind, placebo-controlled parallel design with 32 copd patients gold iii and iv with a oxygen saturation below or equal to 90%. the patients will be treated with three 30-minute pesf- or placebo-sessions distributed over 5 days. directly before the first session, oxygen saturation, quality of life (ccquestionnaire), exercise capacity (6-mwt and grip strength) and phase angle (bia) will be measured and compared to the results directly after the third session. oxygen saturation is also monitored during 24 hours after each session.


Eligibility criteria:
inclusion criteria: * copd patients, post-bronchodilator fev1/fvc \<70% and fev1 \<50% predicted * oxygen saturation without suppletion \<=90% (home use of oxygen suppletion is allowed, but will be stopped during pesf-treatment) * stable medication (no foreseeable need to change therapy) * able to understand the purpose and method of research after adequate information and the ability to decide on participation * signed informed consent exclusion criteria: * known malignant condition with limited life expectancy * carrier of electrical equipment (pacemaker, icd etc) * copd exacerbation in the last 3 weeks * woman who are pregnant or of childbearing age without effective contraception * manifest acute infection * patients with manifest decompensatio cordis * rehabilitation/reactivation program within 2 months before or during the study
cancer: thriving and surviving online workshop and study for cancer survivors

Conditions: Blood Cancer; Breast Cancer; Prostatic Neoplasms; Colorectal Neoplasms; Neoplasms

Summary: cancer: surviving and thriving is a 6-week workshop for cancer survivors. the overall goal of the study is to determine whether an online cancer survivor education and support workshop can have lasting beneficial effects in helping survivors improve their self-management of health skills and quality of life.

this workshop is aimed at helping you better manage your own health and the demands placed on you because of your cancer diagnosis. it is hoped that the workshop will give you the skills needed to reduce stress and improve your quality of life. if successful, the workshop can be made available to other cancer survivors. each workshop is 6 weeks with new lessons each week. you will be asked to log on at your convenience 2-3 times each week for a total of 1-2 hours, to read the lessons, complete assignments, and share your ideas and experiences with your classmates. there are no requirements that participants log in at the same time. with the moderators and other workshop participants, you will discuss: * healthy eating * managing fatigue * managing stress * starting and maintaining an appropriate physical activity program * getting a good night's sleep * dealing with difficult emotions * solving the problems caused by having had cancer * communicating better with your health care professionals * communicating better with your friends, family and coworkers

Eligibility criteria:
inclusion criteria:any adult (19 and over) cancer survivor living in the united states who: 1) was diagnosed within the past 5 years with a new or recurring cancer since the original diagnosis; 2) has completed their cancer treatment (surgery, radiation and/or chemotherapy); 3) isn't currently being treated for cancer except for hormonal therapy; and 4) has and email account and access to high speed internet connection. exclusion criteria:not meeting the inclusion criteria
effects of sugary drinks counter-marketing messages

Conditions: Obesity; Weight Prejudice; Weight Gain; Dietary Habits

Summary: this study aims to examine consumer responses to traditional and counter-marketing messages discouraging sugary drink consumption, including effects on intentions to consume sugary drinks and perceived weight stigma. because prior research has suggested that counter-marketing may be especially effective among younger populations, the investigators will examine effects overall and by age group (young adults \[ages 18-29 years\] vs. middle and older adults \[ages 30+ years\]).

in this online randomized clinical trial, participants will be randomized to one of three arms: 1) control (neutral) messages, 2) traditional health messages, and 3) counter-marketing messages. in each arm, participants will view four messages developed for their randomly assigned arm and answer questions about the messages and their behavioral intentions.

Eligibility criteria:
inclusion criteria: * 18 years old or older exclusion criteria: * less than 18 years old

Keywords: counter-marketing health communication sugar sweetened beverage
a new scoring system improves diagnostic accuracy of intestinal dysganglionosis --a prospective study

Conditions: Hirschsprung Disease

Summary: 1. the investigators previously reported a simple diagnostic scoring system to differentiate hirschsprung disease (hd) from hirschsprung disease allied disorders (had) in the patients with suspected intestinal dysganglionosis. in the retrospective study, the investigators concluded that the patients with a predicting score of more than 5 are more likely to be diagnosed with hd, whereas a score less than 5 is mostly indicative of had. 2. since it is essential to confirm the accuracy and efficacy of the scoring system in a prospective manner before it is used as a standard procedure, this prospective study is designed and performed.

1. patients have hard or firm stools for 2 or less per week, and with ages from newborn to 3 years old are recruited in this study. 2. the recruited patients is undergoing preoperative work-up including barium enema (be), anorectal manometry (arm) and histochemical acetylcholinesterase (ache) staining of rectal mucosa. known risk factors for intestinal dysganglionosis (ids) are recorded. the predicting score is calculated by summing the scores of the risk factors and 3 preoperative tests. 3. the patients with a predicting score of more than 5 are diagnosed with hd, and are performed surgery to remove the aganglionic bowel. 4. the patients with a score less than 5 are mostly indicative of had, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. when there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.

Eligibility criteria:
inclusion criteria: * hard or firm stools for 2 or less per week * age are from newborn to 3 years old exclusion criteria: * children\>3 years of age * patients presented severe inflammation or malnutrition, unconsciousness or perforation of intestine

Keywords: intestinal dysganglinosis hirschsprung disease hirschsprung disease allied disorders diagnostic scoring system prospective study
valiloxybate (xw10172 mr) efficacy and safety parkinson's disease study

Conditions: Parkinson Disease; Excessive Daytime Somnolence

Summary: following screening visit and verification of inclusion/exclusion criteria and informed consent, participants will undergo a multiple sleep latency test (mslt) and polysomnogram (psg) assessments to confirm eligibility for randomization. participants will be randomized to two groups: placebo or xw10172 mr. the drug will be taken orally at bedtime for 6 weeks of treatment that will consist of a 2-week dose escalation/titration period and a 4-week stable-dose maintenance period. there will be a 2-week safety period following dosing.


Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease consistent with the uk-pd society brain bank criteria and pd duration at least 1 year with modified hoehn and yahr stage 1-3 in the off state. * patient reported history of excessive daytime sleepiness (e.g., frequent dozing, nodding, or naps). * anti-parkinson's medications at stable doses for at least 1 month prior to the baseline visit and can maintain a fixed, stable dose throughout the study * epworth sleepiness scale score of \>10 at screening. * female participants of childbearing potential must test negative in a serum pregnancy test at screening and have a negative urine pregnancy test at the baseline and visit. women with childbearing potential must use an acceptable method of contraception during the study and for at least 30 days after completion of dosing. exclusion criteria: * atypical or secondary parkinsonism * significant medical conditions. * evidence of moderate or severe sleep disordered breathing. * drugs that affect sleep including cns depressants and stimulants. * montreal cognitive assessment (moca) examine score \<24. * hospital anxiety and depression scales (hads) \>11. * have an occupation that requires variable shift work or routine night shifts or travel across two or more-time zones.
associative memory in autism spectrum disorder

Conditions: Autistic Disorder

Summary: the aim of this study is to investigate the neural substrates of associative memory in autism spectrum disorder using both behavioural and eeg assessments.


Eligibility criteria:
inclusion criteria: * right handed children from 10 to 18 years old * informed consent signed by the legal representative and adolescent himself. * medical examinations, psychopathology, and cognitive examination in accordance with inclusion and exclusion criteria specific to each population: * people with asd: * participants with asd without mental retardation with a diagnosis in reference to the dsm v criteria * controls : participants without asd main exclusion criteria: * mental retardation, * schizophrenia, * adhd, * head injury with lost of consciousness

Keywords: autism spectrum disorder development memory erd
a phase ii randomized controlled trial to determine the efficacy of an augmented reality game in pediatric cancer patients who are opioid naïve undergoing surgery to reduce postoperative opioid use (gaming-on study)

Conditions: Pediatric ALL; Cancer

Summary: to learn if playing an augmented reality game called spellbound can reduce pain and the need for opioids in young patients scheduled for surgery.

primary objective: •to assess the efficacy of spellbound's ar-enabled scavenger hunt to reduce the rate of 90-day opioid use in pediatric cancer patients undergoing surgery compared to a control non-ar game in a randomized controlled trial. secondary objectives: to assess the effect of ar versus non-ar control technology in pediatric oncology patients, including: * inpatient opioid use * average daily inpatient pain score * number of opioid requests during the hospital stay * inpatient pedsql (quality of life) questionnaire score * ambulation/"out of bed" movement * number days to discharge-ready status * patient experience assessed by satisfaction scores on a questionnaire designed by md anderson cancer center child life team. * outpatient opioid consumption reported at 30, 60, and 90 days * outpatient pain scores reported at 30, 60, and 90 days * outpatient pedsql scores reported at 30, 60, and 90 days * potential adverse events related to the use of ar (i.e., falls).

Eligibility criteria:
inclusion criteria: 1. ages 5-15 2. english and spanish-speaking parents/legal guardians and patients 3. undergoing major surgery for cancer requiring postoperative hospitalization is defined as ≥2 hours of duration of surgery and requiring postoperative hospital admission of at least one night 4. expected to be prescribed postoperative inpatient opioids 5. have never taken opioids or have had no daily opioid use within the last 30 days before surgery 6. sufficient cognitive capacity to comprehend and interact with the game. this is defined as the ability to utilize mobile technology (use ipad with or without assistance) and activate and respond to ar experiences within the app as determined by the clinician. 7. both the child and a legal guardian are willing and able to provide informed consent. * the range from 5-to 15 is based on a recent pilot rct in which the pi found that older adolescents (\>15 years of age) were disinterested in the interactive game. exclusion criteria: 1. patients with any daily opioid use within 30 days before surgery. 2. history of documented peripheral neuropathy secondary to cancer treatment 3. inability to demonstrate an understanding of the game from english instructions 4. any additional concerns based on the study physicians' assessments
effect of spectacle distribution to myopic secondary school students in rural communities of liaoning province on communities academic high school enrolment

Conditions: Myopia

Summary: to determine whether provision of free spectacles to rural-dwelling chinese secondary school students with visually-significant refractive error, together with a teacher-based incentive to promote their use, increases the proportion of children going on to academic high school, as opposed to dropping out or pursuing a vocational track.

the investigators propose in the current trial to significantly expand the evidence base for spectacle distribution as the most-effective health intervention to improve educational opportunities for china's under-served rural children and adolescents by assessing impact on school attainment.

Eligibility criteria:
inclusion criteria: * year 1 students (about 12-15 years old) from schools in county-level cities and below in liaoning province * uncorrected (self-glasses) visual acuity of ≤6/12 in both eyes * refractive error meets cut-offs shown to be associated with significantly greater improvement in visual acuity when corrected7 (myopia ≤-0.75 diopters (d, or astigmatism (non-spherical refractive error) ≥1.00 d * best corrected visual acuity ≥6/7.5 in either eye exclusion criteria: * hyperopia ≥2.00 d * presence of visually-significant ocular condition besides refractive error