Kornimate/medical-research-clean huggingface dataset:
mobile self-management of irritable bowel syndrome for adolescents

Conditions: Irritable Bowel Syndrome; Abdominal Pain

Summary: the objective of the proposed research is to conduct user testing of a mobile-based self-management support intervention for adolescents and young adults with irritable bowel syndrome (ibs), a chronic digestive condition. the application (app; bodimojo buddy) uses a virtual coach that can serve to increase patient engagement through interactive skill-building, self-care, and mindfulness-based cognitive behavioral activities. if the bodimojo buddy mobile app is successful, it will have a significant public health impact by providing a mobile resource to the 10-15% of the us population who suffer from ibs and potentially improving health outcomes and reducing significant costs to the us healthcare system. study participation involves participants downloading and using the app for 30 days. during the 30 days, participants will interact with the app by inputting their current mood, receiving supportive feedback from the app, reading messages, and doing brief activities (such as relaxation activities, etc.). before and after the 30 days of user testing, participants will complete a few brief questionnaires about their behavior, how their symptoms affect their life, and how they receive support from others. these questions will take around 20 minutes to complete at each administration.


Eligibility criteria:
inclusion criteria: 1. age 13-21 years 2. for adolescents: parent-reported physician diagnosis of ibs, using pediatric rome iii diagnostic criteria for functional gastrointestinal disorders. for young adults: self-reported physician diagnosis of ibs using rome iii diagnostic criteria, or meeting criteria for ibs or functional abdominal pain as determined during phone screening. 3. have daily use of an iphone or ipad that meets the following technical specifications: at least ios 8; for iphones, must be iphone 5 or above. 4. able and willing to give informed assent/consent and comply with study requirements 5. have one caregiver willing and able to participate in the study \[only for 13-17 year olds\] exclusion criteria: 1. inability to provide informed assent/permission/consent 2. inability to read, speak, and understand english (because the app content/parent guides are written in english, as are the measures being used in the study)
evaluation and comparison of efficacy between extracorporeal magnetic innervation and high-intensity kegel exercise regimen in treatment of stress urinary incontinence in female

Conditions: Stress Urinary Incontinence

Summary: the aim of this prospective, randomized controlled study is to evaluate and compare efficacy between the most available conservative treatment (magnetic stimulation and kegel exercise) for stress urinary incontinence in croatia. we will assess quality-of-life, patient global improvement, and vaginal pressure measured with perineometer in three different time points: at the enrollment, after 8 weeks of treatment and 3 months after the both treatments are done.


Eligibility criteria:
inclusion criteria: * urodinamically confirmed stress urinary incontinence, at least one vaginal delivery in gynecological history. exclusion criteria: * urinary tract malignancies, vulvovaginitis, current uroinfection, previous pelvic surgeries, neurologic and psychiatric diseases, previous conservative treatment of stress urinary incontinence in less than 6 months, stage iii and iv of genital prolapse, latex allergy.
cell-free tumor dna in head and neck cancer patients

Conditions: Head and Neck Cancer; Head and Neck Neoplasms; Head and Neck Squamous Cell Carcinoma; Oropharynx Cancer; Oropharynx Neoplasm; Oropharynx Carcinoma; Oral Cavity Cancer; Oral Cancer; Oral Neoplasm; Larynx Cancer; Larynx Carcinoma; Larynx Neoplasm; Nasopharyngeal Carcinoma; Nasopharyngeal Cancer; Nasopharynx Neoplasm; Hypopharynx Cancer; Hypopharynx Neoplasm; Hypopharynx Carcinoma; Sinonasal Carcinoma; Thyroid Carcinoma; Thyroid Cancer; Thyroid Neoplasms; Salivary Gland Cancer; Salivary Gland Neoplasms; Salivary Gland Carcinoma; Sinonasal Cancer; Sinonasal Neoplasm

Summary: this study investigates if head and neck squamous cell carcinoma can be tracked with cell-free tumor dna, rna or hpv-dna, in blood samples from patients referred with suspicion of cancer, and if it can be used in detecting recurrence in patients already diagnosed and treated for head and neck squamous cell carcinoma.


Eligibility criteria:
inclusion criteria: * patients 18 years old or older * suspicion of head and neck cancer exclusion criteria: * diagnosed with cancer within the last 3 years ( apart from basal cell carcinoma) * diagnosed with an inflammatory or haematological disease after the age of 18 * received chemotherapy or immunosuppressive treatment within the last 3 years * underwent a fna ( fine-needle aspiration biopsy) or a biopsy from the head and neck region within 1 week.
reducing internet gaming

Conditions: Internet Gaming Disorder

Summary: the fifth revision of the diagnostic and statistical manual for mental disorders includes in its research appendix a potential new diagnosis-internet gaming disorder. this condition primarily affects adolescent boys and young adult men, who rarely seek treatment on their own. more often, parents express concerns about their child's game playing behaviors. this psychotherapy development study will evaluate feasibility and effect sizes of an intervention designed to help parents reduce their child's gaming problems; the intervention allows for child participation, but it is geared toward parents, regardless of whether or not their child is willing to participate. a total of 40 parents concerned about their child's gaming behaviors will complete self and parental report inventories and structured diagnostic interviews regarding gaming, substance use and psychosocial functioning. children who elect to participate will complete parallel versions of the instruments. participants will be randomized to a control condition consisting of referral for mental health issues and family support services or to a 6-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors. gaming and other problems will be assessed pre-treatment, at the end of treatment and at a 4-month follow-up. this study will be the first to evaluate the reliability and validity of a parental version of the fifth revision of the diagnostic and statistical manual for mental disorders criteria for internet gaming disorder in a clinical sample, and it will assess associations of internet gaming disorder with substance use, mental health conditions, and family functioning as well. this study will be the first randomized trial of an intervention designed to assist parents in reducing their child's gaming problems, and results will help guide future development of interventions for internet gaming disorder. to evaluate the feasibility and acceptability of this intervention, the proportion of parents assigned to the intervention who complete 6 sessions will be examined, as will the proportion of youth who attend the sessions. parent and child ratings of satisfaction with the intervention will be assessed. to examine the effect size of the intervention on reducing gaming, parental reports of proportion of days on which their child played games and durations of game playing will be compared between conditions, controlling for baseline indices.


Eligibility criteria:
inclusion criteria: * parent/guardian of a 10-22 year old residing in the same household \>8 months/year * reports significant problems with game playing exclusion criteria: * have a condition that may hinder study participation
pieb compared with cei on breakthrough pain in nulliparous women

Conditions: Breakthrough Pain

Summary: the goal of this randomized controlled trial is to examine the impact of programmed intermittent bolus epidural analgesia technique on the incidence of breakthrough pain during labor in nulliparous women compared to continuous epidural infusion. nulliparous women will randomly be divided during labor into two groups; study group will receive mix of bupivacaine and fentanyl once (bolus) every 60 minutes; the control group will receive continuously the same dose during an hour, until delivery.

there are several pharmacological and non-pharmacological techniques for pain relief during labor. epidural analgesia is considered the most effective modality for intrapartum pain relief. maintenance of epidural analgesia is achieved by different techniques; continuous epidural infusion (cei), intermittent epidural analgesia (iea), patient control epidural analgesia (pcea) and combination between the techniques. another technique, the programmed intermittent bolus epidural analgesia (pibea). the advantage of this technique is that boluses are given all the time at planned intervals, so laboring women do not depend on the medical staff to receive the bolus when there is a breakthrough pain. this method has been reported to be associated with less motor block, lower incidence of instrumental vaginal deliveries, and less consumption of anesthetic agents when compared to cei. there are no conclusive data regarding the use of pibea in combination with pcea compared to cei and pcea on the effect of pain relief during labor and birth outcomes. the hypothesis of the current trial is that pibea and pcea will decrease the incidence of breakthrough pain, and probably shorten the second stage of labor, lead to fewer instrumental deliveries and higher women's satisfaction compared to cei and pcea.

Eligibility criteria:
inclusion criteria: * nulliparous women * term pregnancy * singleton * vertex presentation * latent phase (cervical dilatation \<6 cm) * epidural analgesia request * visual analogue scale score \> 40 exclusion criteria: * estimated fetal weight \> 4 kg * intra uterine fetal death * drug sensitivity * anomalous fetus * contraindication for epidural analgesia

Keywords: nullipara term pregnancy singleton vertex presentation latent phase maternal request for epidural visual analogue scale > 4
efficacy study of mcs110 given with carboplatin and gemcitabine in advanced triple negative breast cancer (tnbc)

Conditions: Advanced Triple Negative Breast Cancer (TNBC) With High TAMs

Summary: to determine whether mcs110 antibody therapy improves the efficacy of carboplatin and gemcitabine (carbo/gem) in advanced tnbc patients


Eligibility criteria:
inclusion criteria: * adult women (≥ 18 years of age) with advanced tnbc. * histological or cytological evidence of estrogen-receptor negative (er-), progesterone receptor negative (pgr-) and human epidermal growth factor-2 receptor negative (her2-) breast cancer by local laboratory testing, based on last available tumor tissue. * er/pgr negativity to follow local guidelines * if ihc her2 2+, a negative fish test is required * a pre-treatment tumor biopsy demonstrating high tam content as assessed per the central laboratory * patients must have: at least one measurable lesion per recist 1.1. (note: measurable lesions include lytic or mixed (lytic + blastic) bone lesions, with an identifiable soft tissue component that meets the measurability criteria) exclusion criteria: * prior chemotherapy for advanced bc. previous adjuvant/neoadjuvant chemotherapy is allowed (carboplatin, cisplatin or gemcitabine only if \> 12 months has passed since last administration). * therapy for underlying malignancy within 2 weeks prior to start of study treatment: * chemotherapy, biologic therapy (antibodies and biologically targeted small molecules) * radiotherapy * major surgery * patients receiving concomitant immunosuppressive agents or chronic corticosteroids (≥10 mg of prednisone or equivalent) at the time of first study dose. * clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening. * known history of human immunodeficiency virus or active infection with hepatitis virus or any uncontrolled active systemic infection. * patients with the following laboratory values during screening and on day 1 predose: * absolute neutrophil count (anc) \< 1.5x109/l * hemoglobin \< 9 g/dl * platelets \< 100x109/l * serum creatinine \> 1.5 x uln * serum total bilirubin \> 1.5 x uln * ast/sgot and alt/sgpt \> 3.0 x uln

Keywords: mcs110; carboplatin; gemcitabine; tnbc; tams
effect of pregabalin or adductor canal block on postoperative analgesia

Conditions: Postoperative Pain After Knee Arthroscopy

Summary: arthroscopically anterior cruciate ligament reconstruction (acl) under spinal anesthesia were included in this study.

patients who american society of anesthesiologists (asa) classification i to ii scheduled to undergo arthroscopically assisted acl reconstructions under spinal anesthesia are included in this study. the first group is administered 150 mg oral pregabalin 1 hour before surgery and the postoperative sham block was performed with an ultrasound probe. the second group is the control group; patients in this group are administered a placebo capsule 1 hour before surgery and sham block was performed with an ultrasound probe.the third group is administered a placebo capsule 1 hour before surgery and postoperative adductor canal block is performed. all patients will be received postoperative a tramadol i.v. patient control analgesia device. at the end of 24 hours, the total amount of tramadol consumed by the patient will be recorded from the patient control analgesia. nrs score, white fast track, satisfaction will be questioned.

Eligibility criteria:
inclusion criteria: * patients between the ages of 18 and 70 years * american society of anesthesiologists i or ii * scheduled to undergo knee arthroscopy exclusion criteria: * allergic to any medicines * history of drug or alcohol abuse, * opioids or sedative medications * history of psychiatric conditions * pregnant or lactating women

Keywords: pregabalin adductor canal block postoperative pain
a study for evaluation of gsk biologicals' pandemic influenza vaccine

Conditions: Influenza

Summary: this observer-blind study is designed to evaluate the immune response and safety of pandemic influenza vaccine in the elderly population.


Eligibility criteria:
inclusion criteria: * male or female subjects aged 61 years or above at the time of the first study visit (day -30). * female subjects of non-childbearing potential. * healthy subjects or subjects with well controlled chronic medical condition (at the discretion of the investigator). * written informed consent obtained from the subject. * access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but not a pay phone or other multiple-user device. * subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. exclusion criteria: * previous administration of the licensed mf59-containing vaccines, e.g. fluad™ or addigrip™ or virosome-based influenza vaccines such as inflexal v™, infectovac flu™ or invivac™ . * previous administration of the 2009 southern hemisphere or 2008-2009 northern hemisphere influenza vaccine. * previous administration of a pandemic influenza vaccine. * administration of licensed vaccines within 4 weeks prior to enrolment in this study. * planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination with h5n1 vaccine. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first study vaccination. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * history of chronic alcohol consumption and/or drug abuse. * history of hypersensitivity to vaccines. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. * acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * acute disease and/or fever at the time of enrolment. * serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.. * administration of immunoglobulins and/or any blood products within the three months preceding the first study vaccination or during the study. * use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to the first vaccination, or planned use during the study period. * any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Keywords: pandemic influenza
crossover comparison of multihance and dotarem

Conditions: Brain Disease

Summary: this study aims at a comparison between multihance at a dose of 0.1 mmol/kg and 0.05 mmol/kg and dotarem at a dose of 0.1 mmol/kg in brain tumor patients to show superiority of multihance.

this crossover study aims at a comparison between 0.1 mmol/kg multihance and 0.1 mmol/kg dotarem, between 0.05 multihance and 0.1 mmol/kg dotarem in terms of diagnostic preference at ce-mri in brain tumor patients to show superiority of multihance.

Eligibility criteria:
inclusion criteria: * are at least 18 years of age or older * are able to give written informed consent and are willing to comply with the protocol requirements * are scheduled to undergo mri * are willing to undergo two mri procedures within 14 days * have confirmed or are highly suspected to have brain tumor(s) (primary or secondary), as determined by: * clinical/neurological symptomatology; * diagnostic testing, such as ct or previous mri examinations; or * have had recent brain surgery and are to be evaluated for recurrence exclusion criteria: * are pregnant or lactating females. exclude the possibility of pregnancy: * by testing on site at the institution within 24 hours prior to the start of each investigational product administration; or * by history (i.e., tubal ligation or hysterectomy); or * post menopausal with a minimum of 1 year without menses * have any known allergy to one or more of the ingredients in the investigational products, or have a history of hypersensitivity to any metals * have congestive heart failure (class iv according to the classification of the new york heart association) * have suffered a stroke within a year * have received or are scheduled to receive any other contrast medium in the 24 hours preceding through the 24 hours following exam 1, and in the 24 hours preceding through the 24 hours following exam 2 * have received or are scheduled to receive an investigational compound and/or medical device within 30 days before admission into the present study, through the 24 hours post-administration of the second investigational product * have moderate-to-severe renal impairment, defined as glomerular filtration rate (gfr)/estimated gfr \< 45 ml/min * have been previously entered into this study * have received or are scheduled for one of the following: * surgical or chemotherapeutic treatment within three weeks prior to the first examination or between the two examinations * initiation of steroid therapy between the two examinations * radiosurgery between the two examinations * have any contraindications to mri such as a pace-maker, magnetic material (i.e., surgical clips) or any other conditions that would preclude proximity to a strong magnetic field * are suffering from severe claustrophobia * have any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations

Keywords: confirmed brain disease highly suspected brain disease
three-part program for parents with premature infants

Conditions: Premature Birth

Summary: this study evaluated the efficacy of a comprehensive, three-part program for parents of premature infants. this program was designed to improve development in preterm children and includes an educational video, tests to evaluate the child's strengths and abilities, and instruction in infant massage.

premature birth is a major cause of developmental delay, and cost-effective, replicable methods to promote development in preterm children are needed. despite the success of first generation interventions, little is understood about why early intervention does not affect all parents and preterms to the same degree. this study assessed the efficacy of a three-component intervention (psychoeducational video, serial administrations of the brazelton neonatal behavioral assessment scale, and parent-administered infant massage) that targets preterm infants and their mothers and fathers. outcome measures included infant physical, intellectual, and socioemotional development; parental sensitivity; and infant-parent attachment. the project also assessed the role of parental state of mind regarding attachment and parental commitment to the intervention. participants in this study were urban african american mothers and fathers of preterm, low birthweight infants admitted to the neonatal intensive care unit. fathers were eligible for the study if nominated by the child's mother. participants were randomly assigned to an intervention group or a control group. both groups were comparable with respect to race, maternal pregnancy history, education, income, presence/absence of partner, infant gestational age, infant small-for-date status, and infant gender. the intervention group viewed a videotape about preterm infant abilities. over the course of the study, the intervention group administered infant massage and completed multiple administrations of the brazelton neonatal behavioral assessment scale with increasing parental involvement. the intervention began when infants were 32 to 36 weeks post-conceptual age (pca) and ended when infants are 52 to 56 weeks pca. the efficacy of the intervention and the moderating roles of adult attachment and parental commitment to the intervention were evaluated in terms of infant physical, mental, motor, and social development, and parental adjustment and sensitivity to the infant during the first 2 years.

Eligibility criteria:
inclusion criteria: * infants born \< 37 weeks gestational age * mothers 18 years of age or older * african american exclusion criteria: * infants with chromosomal abnormalities or other genetic syndromes * mothers with positive postpartum toxicology screens * infants destined for foster care note: age limits for infants refer to post-conceptual age (not actual age)

Keywords: prematurity low birthweight parenting intervention
alk21-021: a safety study of medisorb® naltrexone (vivitrol®) administered to health care professionals

Conditions: Opiate Dependence

Summary: the purpose of this study is to determine the safety and tolerability of medisorb® naltrexone (vivitrol®) when administered over a period of 24 months to health care professionals who have a history of opioid dependence.


Eligibility criteria:
primary inclusion criteria: * health care professional (eg, physician, osteopath, nurse, pharmacist) * 18 years of age or older * enrolled or enrolling in an extended outpatient treatment program for opioid dependence * women of childbearing potential must agree to use an approved method of contraception for the duration of the study primary exclusion criteria: * pregnancy and/or lactation * evidence of hepatic failure * active hepatitis * any psychiatric disorder that would compromise ability to complete study requirements * recent history of suicidal ideation or attempt * current dependence to any drugs other than prescription opioids or heroin, benzodiazepines, caffeine, marijuana, alcohol, or nicotine * positive urine drug test or self-reported use of opioids, cocaine, or amphetamines at screening

Keywords: opioid dependence vivitrol opioid-related disorders