Kornimate/medical-research-clean huggingface dataset:
testing a mobile app to improve toothbrushing skills and habits in teens with autism

Conditions: Autism

Summary: the goal of this proposed trial will modify an existing toothbrushing app for teens with autism and compare toothbrushing outcomes with a control app. we have 2 specific aims: * during the 2-year ug3 phase, we will use the discover, design+build, and test framework to modify our existing app and pilot the intervention. * during the 4-year uh3 phase, we will recruit 270 pre-adolescents and teens with autism ages 10 to 17 years, randomize participants to one of two arms, and compare outcomes. participants will asked to use the app, complete surveys on redcap, participate in feedback interviews and focus groups. behavior change in the experimental group will be compared with that in the control group.

adolescents with autism are at increased risk for tooth decay in part because of poor diet and toothbrushing habits. effective ways to reduce added sugar intake have yet to be tested, but technologies exist to help improve toothbrushing. mobile health apps are a promising but underutilized way to improve and enforce toothbrushing habits. many adolescents with autism are enamored with technology and own devices that support apps. we propose a stage ii efficacy trial in modifying a toothbrushing app and inform behavior change in the target population.

Eligibility criteria:
inclusion criteria: * child participants will have autism spectrum disorder that will be confirmed by: (1) chart review by clinical staff at the recruitment sites to determine if the child meets the dsm-5 criteria for autism spectrum disorder; or (2) affirmative caregiver response (yes) to the question, "has a healthcare provider ever diagnosed your child with autism?" * willingness to take a cars-2 \[childhood autism rating scale-2\], which will be administered by trained staff * child brushes independently \[the child needs to be able to hold the toothbrush and move it around their teeth, mostly unassisted\] * child uses touch screen devices (e.g.,smartphones or tablet) * ages 10 to 17 years at enrollment * caregiver and child able to communicate in english * caregiver age ≥18 years and able to provide informed consent in english * child and caregiver live in the same home * child has ready access to a mobile device with a front-facing camera onto which apps can be downloaded (ipad or iphone with ios 16.0+; android tablet or phone with android 13.0+) * family has a wi-fi or cellular data plan to allow app data to be transmitted, with confirmation of via tools like the ookla speed test to help problem solve and ensure that app data can be transmitted exclusion criteria: • children with autism younger than age 10 years will be excluded

Keywords: toothbrushing app clinical trial habit formation evidence based
comparison of neuromodulatory treatment of migraine headache with acupuncture and transcranial direct current stimulation

Conditions: Migraine

Summary: the goal of this clinical trial is to compare effects of the treatment with acupuncture and transcranial direct current stimulation (tdcs) in patients with migraine headache. the main questions it aims to answer are: * is tdcs more effective than acupuncture/placebo? * is there any difference in venous blood inflammatory parameters (cgrp (calcitonin gene related peptide), il (interleukine) -6, il-8. il-10, saa (serum amyloid a) and esr (erythrocyte sedimentation rate) before/after treatment? * could these inflammatory parameters function as biomarkers of disease and/or indicators of treatment's efficacy? participants will regularly fill out questionnaires (migraine diary) and their venous blood before/after treatment will be taken for analysis. researchers will compare the effects of sham and verus treatment of both methods before and after treatment.


Eligibility criteria:
inclusion criteria: * 4 migraine days per month * no acupuncture in the past * understanding of study design and ability to give informed consent exclusion criteria: * severe psychiatric disorders * pacemaker * status post brain surgery with open skull * brain stimulators * metal implants * biologic drugs * pregnancy

Keywords: tdcs acupuncture cgrp inflammatory biomarkers
multi-center prospective study on e-notes for myomectomy with traction of multidirectional sutures

Conditions: Myoma

Summary: primary objectives : to investigate technical feasibility and postoperative morbidity after e-notes for myomectomy with traction of multidirectional sutures secondary objectives : to investigate postoperative pain after e-notes for myomectomy with traction of multidirectional sutures by clinical variables such as incision size, type of port, size and number of myoma, or operation time.

* leiomyoma is a common benign tumor of the smooth muscle cells of the myometrium.1 it can cause several symptoms such as abnormal vaginal bleeding, pain, or urinary symptoms according to size and location. steadily, lesser invasive surgeries have been preferred for such benign disease (laparotomy, laparoscopy, and then single-port surgery).2,3 * however, these minimal approaches, laparoscopic morcellation of preoperatively suspicious leimyoma, have the potential risk of peritoneal seeding of postoperative diagnosed leiomyosarcoma in the pathological examination.4 currently, safe morcellation is also required during myomectomy while using a lesser invasive surgical approach such as single-port surgery or natural orifice transumbilical endoscopic surgery (notes). * during single-port surgery or embryonic notes (e-notes) via an umbilicus, handling of myoma into different directions could be quite a big challenge. fortunately, myoma is enough hard to pull with string and has a tendency not to rupture during manipulation of these strings. * these concepts lead to traction of anchoring sutures during e-notes for myomectomy applied in the current case. safe morcellation could be guaranteed, because direction morcellation via an umbilicus is possible in an endobag. * this useful and safe surgical approach needs to be confirmed in multi-centers in terms of feasibility and morbidity.

Eligibility criteria:
inclusion criteria: * women who are surgically candidate for myomectomy * age \> 20 years exclusion criteria: * contraindications for laparoscopic surgery and/or general anesthesia. * greater than five fibroids sized of 3cm or more * uterus extending beyond the umbilicus * major medical comorbidity or psychiatric illness, which could affect follow-up and/or compliance * patients undergoing concomitant complex surgical procedures at the time of myomectomy (such as resection of severe endometriosis etc.) * pregnancy * patients with any suggestion of malignancy in the pelvis * patients with cooperation of another main surgical procedures such as severe adhesiolysis or low anterior resection * patients who are severely anemic or who have significant medical conditions such as cardiac or pulmonary disease * patients who refuse to participate or give consent to the procedures

Keywords: myoma uterine myomectomy
rituximab in metastatic melanoma

Conditions: Metastatic Melanoma

Summary: the purpose of this study is to determine whether rituximab as an adjuvant therapy in clinical stage iiic / iv (no evidence of disease, ajcc (american joint committee on cancer) 2002) melanoma patients is safe and prolongs overall survival and disease-free interval.


Eligibility criteria:
inclusion criteria: * histologically verified non-ocular melanoma stage iiic/iv, no evidence of disease exclusion criteria: * ecog (eastern cooperative oncology group) performance status \> 2 * ocular melanoma * immunodeficiency syndromes or hypogammaglobulinaemia * active autoimmune diseases * treatment with immunosuppressive agents other than steroids * depressed bone marrow function (leukopenia \<3000, platelet count \<100.000) * cardiac insufficiency nyha (new york heart association) iv * active hepatitis b,c, or hiv infection * pregnancy or lactation * interstitial pulmonary disease * former treatment with anti-cd20 antibody

Keywords: melanoma rituximab metastatic stage iiic/iv stem cell overall survival disease free interval anti-cd20 therapy
the effectiveness of temporomandibular joint mobilization and exercise in individuals with chronic neck pain

Conditions: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Neck Pain; Chronic Pain

Summary: to examine the effects of temporomandibular joint mobilization and exercises added to the conventional physiotherapy program on posture, functionality and muscular endurance in individuals with chronic neck pain.

our research is a randomized controlled trial. 50 participants will be included in the study, which will be conducted on individuals aged 18-65 years with chronic neck pain. participants will be divided into 2 groups as experimental and control groups by simple randomization method. all patients will be treated with conventional physiotherapy methods for 4 weeks and 5 days a week. in addition to conventional treatment, temporomandibular joint mobilization techniques were applied to the experimental group; exercises will be given. in the study, temporomandibular dysfunction (tmd) pain screener, neck disability index, and visual analog scale questionnaires will be applied to the patients twice, before and after the treatment. before and after the treatment, the cervical region's range of motion and muscular endurance will be measured by the physiotherapist. pre- and post-intervention data were statistically analyzed and compared.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-65, * having neck pain lasting longer than 3 months, * absence of known systemic disease or trauma history, * volunteering to participate in the research. exclusion criteria: * having a history of trauma in the areas that are the subject of the study, such as head and neck surgery, upper extremity, thoracic and cervical vertebrae, * disc displacement, osteoarthrosis, osteoarthritis signs and symptoms * having a neurological-psychiatric diagnosis that may affect the measurement results.

Keywords: endurance functionality joint range of motion
nirs neurofeedback as a treatment for attention deficit hyperactivity disorder

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the investigators therefore propose a pilot study to establish the effectiveness of nirs neurofeedback training in reducing the intensity of adhd symptom expression on children, improvement of the cognitive and global functions associated with adhd, effects on cerebral blood perfusion in the cortex and safety plus possible unknown side-effects.

background: attention deficit hyperactivity disorder (adhd) is a mental condition originating in childhood, characterized by symptoms of lack attention, hyperactivity and impulsiveness associated with significant functional impairment. currently, the use of neurofeedback as a non-drug alternative technique for treatment of adhd has increasingly spread among the clinical and academic fields, producing relevant findings with regard to its effectiveness. the scp neurofeedback and eeg neurofeedback have been the most studied techniques until the moment, with equipments and systems made available to the market at prices between us$ 10.000 and us$ 20.000, while nirs neurofeedback equipments can be found for around us$ 2.000. due to the low cost of the necessary equipment's and easy access to the technology, the use of nirs neurofeedback was opted for in the search to evaluate the techniques effectiveness in the improvement of adhd symptoms as well as the patients' cognitive performance. this research is an open label treatment trial with nirs neurofeedback training of frontal and pre frontal lobes activation in children school-aged 7 - 12 years old with adhd. ten participants will be recruited over 3 months and will be offered 24 nirs neurofeedback sessions over 12 weeks, 2 sessions per week. the present study will be carried out as part of the care routine of the child and adolescent psychiatry services at hospital de clínicas de porto alegre. primary outcome will be standard clinical behavioural rating scales. secondary outcomes will include neuropsychological parameters, neurofunctional parameters using spect (single photon emission computed tomography), global function, quality of life assessment, side effects and tolerability.

Eligibility criteria:
inclusion criteria: * diagnosed with adhd clinically. * cognitive dysfunction: ≥11/2; standard deviation above norm in at least two neuropsychological measurements: executive functions (inhibitory control), gratification aversion and time processing * not having used adhd medication in at least three months with parental consent for not treating adhd with medication exclusion criteria: * existence of another co-morbid mental disorder which is clinically relevant and demands treatment * iq \< 80

Keywords: nirs neurofeedback attention deficit hyperactivity disorder near infrared spectroscopy adhd
french linguistic and metric validations of parent-proxy qol chronic cough specific questionnaire (pc-qol)

Conditions: Chronic Cough

Summary: cough is one of the most common reasons for consultation. even if cough is a non-specific symptom, it can be the first sign of a chronic pathology. several studies have demonstrated that chronic cough causes quality-of-life (qol) impairment. physicians' incapability to evaluate cough impact and patients' qol has been documented. therefore, a parent-proxy qol chronic cough specific questionnaire (pc-qol) has been developed and validated by chang a. b. objective : the aim of the study is to validate the french version of the pc-qol, a parent-proxy qol chronic cough specific questionnaire. methods : linguistic validation will be performed using backward/forward translation guidelines, and cognitive debriefing by 10 parents. psychometric validation will be tested in 150 patients. inclusion criteria are: patients with a diagnosis of chronic cough (\> 4 weeks); 18 years of age or younger; all etiologies excepting cystic fibrosis. informed consent from parents will be obtained. at enrollement, each parent will fulfill the pc-qol questionnaire and two cough-related measures (visual analogue score, verbal category descriptive). clinical data (medical history, physical examination) will be collected. children qol will be assessed using vspa, kidscreen and qualin questionnaires. for assessing reproductibility and sensitivity to change, parents will be retested 7 and 21 days later. content validity, construct's validity, external validity and instrument's reliability will be explored.


Eligibility criteria:
inclusion criteria: old under age 18 * male or feminine * reached(affected) by chronic cough ( more than 4 weeks), any confused(merged) étiologie * affiliated to a national insurance scheme * having given freely their written consent having been informed about the purpose, about the progress and about the incurred potential risks exclusion criteria: patients of whom the parents(relatives) are incapable to understand(include) the purpose and the conditions of realization of the study, incapable to give their consent * patient whose membership(support) to the protocol is improbable according to the investigator * patient participant in another clinical trial or in period of exclusion from a previous clinical trial
efficacy and safety profiles of combination sedation propofol with midazolam and meperidine.

Conditions: Disorders of Gallbladder, Biliary Tract and Pancrease

Summary: the purpose of this study is to compare efficacy and safety of combination of propofol and midazolam with meperidine versus midazolam and meperidine for ambulatory ercp

ercp is commonly done under sedation with midazolam and meperidine, however some studies showed varying outcomes of this conventional sedation for maintained sedation. propofol is increasing used for sedation in gastrointestinal procedure owing to its rapid recovery profiles but the complications associated with propofol are not negligible.the investigators prospectively compare the efficacy, induction time, recovery time, patient satisfaction and side effect between propofol based and conventional sedations in patients undergoing ercp.

Eligibility criteria:
inclusion criteria: . all outpatients aged more than 18 years who were schedule for ercp - exclusion criteria: * pregnant woman * emergency situation ( i.e. concomitant upper gastrointestinal bleeding, acute cholangitis ) * american society of anesthesiologist ( asa )class iv or v * respiratory disease, * sleep apnea * allergy to egg or soybean * drug abuse( benzodiazepine, opioid agonist ) * previous history of failure sedation

Keywords: propofol midazolam meperidine
fecal microbial transplantation and vedolizumab treatment of crohn's disease

Conditions: Crohn Disease; Microbial Substitution

Summary: the investigators postulate that by determining a patient's baseline microbiome and manipulating it through fecal microbial transplantation (fmt) may improve response rates to vedolizumab in crohn's disease (cd) patients. primary objective: to determine whether manipulation of gut microbiome by fmt pre vedolizumab treatment is safe and results in higher remission rates in cd patients. study design: a randomized double blinded controlled clinical trial. study population:cd patients 18-65 yo, men and women, with mild-moderately active disease determined by the harvey-bradshaw index (hbi) of 5≤hbi≤15, who were found eligible to commence treatment with vedolizumab. study procedure: study participants will receive fmt within a week prior to first vedolizumab infusion. all patients will be followed for 46 weeks in 8 visits at the ibd clinic in the gi department of the tel aviv medical center.

study design: a randomized double blinded controlled clinical trial. study population: cd patients 18-65 yo, men and women, with mild-moderately active disease determined by the harvey-bradshaw index (hbi) of 5≤hbi≤15, who were found eligible to commence treatment with vedolizumab (screened for tuberculosis and hepatitis b and without an active infection or an abscess) will be enrolled in the study. follow-up: all patients will be followed by physician assessment, sample collection, anthropometric measurements and questionnaires during the scheduled visits at weeks 2, 6, 14, 22, and at week 46, on which they will undergo a colonoscopic examination as part of their regular clinical followup. side effects (se): will be monitored by phone, 3 days post intervention and at vedolizumab infusion visits at weeks 2 and 6. also, patients will receive direct contact details of both the study coordinator and the study pi.

Eligibility criteria:
inclusion criteria: 1. mild-moderately active disease determined by the harvey-bradshaw index (hbi) of 5≤hbi≤15 2. found eligible to commence treatment with vedolizumab (screened for tuberculosis and hepatitis b and without an active infection or an abscess) exclusion criteria: 1. cd patients in remission (hbi\ 16) 2. patients with a stoma 3. hospitalized patients 4. patients with an active intestinal infection- positive stool culture or clostridium difficile infection 5. severe disease - malignant disease, hepatic failure, renal failure, cardiovascular, metabolic, neurological disease 6. pregnant/lactating women 7. inability to sign an informed consent 8. inability to complete the study protocol 9. an ongoing or planned antibiotics therapy 10. severe food allergies
pain related to local anesthetic administration for nexplanon placement

Conditions: Pain Related to Local Anesthetic Administration for Nexplanon Placement

Summary: this research study is being conducted to see if using buffered lidocaine for nexplanon placement decreases pain associated with administering local anesthesia compared to unbuffered lidocaine, which is currently used in clinic. lidocaine is used to stop pain in the nerve fibers in order to decrease pain at the time of the procedure. we want to find out if using buffered lidocaine will decrease discomfort at the time of receiving local anesthesia for nexplanon insertion.


Eligibility criteria:
inclusion criteria: * ability to provide informed consent * women, aged 18-50 who are english or spanish speaking who present for nexplanon placement for contraception * participants must not have a past medical history of substance use disorders, pain disorders, use of pain medications or are found to be pregnant exclusion criteria: * current use of pain medication prior to procedure * diagnosed chronic pain condition * pregnancy * known allergic reactions to components of the local anesthetic * history of nexplanon placement * current substance use or history of substance use * known contraindications to nexplanon, such as history of breast cancer, systemic lupus erythematosus with positive (or unknown) antiphospholipid antibodies, unexplained vaginal bleeding, and liver conditions, including hepatocellular adenoma, malignant liver tumor, and decompensated cirrhosis.
promoting awareness fetal movements to reduce fetal mortality stillbirth, a stepped wedge cluster randomised trial.

Conditions: Decreased Fetal Movements Affecting Care of Mother; Pregnancy; Stillbirth

Summary: rates of stillbirth in scotland are among the highest in resource rich countries. the majority of stillbirths occur in normally formed infants, with (retrospective) evidence of placental insufficiency being the commonest clinical finding. maternal perception of decreased fetal movements appears to be an early biomarker both of placental insufficiency and subsequent stillbirth. the study proposed here will test the hypothesis that rates of stillbirth will be reduced by introduction of a package of care consisting of strategies for increasing pregnant women's awareness of the need for prompt reporting of decreased fetal movements, followed by a management plan for identification of placental insufficiency with timely delivery in confirmed cases. the odds of stillbirth fell by 30% after the introduction of a similar package of care in norway but the efficacy of this intervention (and possible adverse effects and implications for service delivery) have not been tested in a randomized trial. the investigators plan a stepped wedge cluster design trial, in which hospitals in scotland and ireland will be randomized to the timing of introduction of the care package. outcomes (including the primary outcome of stillbirth) will be derived from scotland and ireland's detailed routinely collected maternity data, allowing the investigators to robustly test the hypothesis. a nested qualitative study will examine the acceptability of the intervention to patients and health care providers and identify process issues (barriers to implementation).


Eligibility criteria:
inclusion criteria: * the study will include all women delivering at one of the maternity units involved in for the duration of the study. exclusion criteria: * women delivering in the "washout" period in each unit.

Keywords: education, stillbirth, prevention, management