Kornimate/medical-research-clean huggingface dataset:
is it helpful to use fitbits in a family based weight loss program?

Conditions: Pediatric Obesity

Summary: this study evaluates the role of personal activity trackers to help improve weight loss or weight maintenance for children and their parents enrolled in a comprehensive weight loss program.

childhood obesity rates have tripled in the last 30 years, with as many as 50% of children in the us being obese or overweight. high-intensity comprehensive behavioral family lifestyle intervention (cbfli) programs have been shown to be among the most effective interventions for weight loss in children. however, these programs are time- and resource-intensive with high rates of recidivism. personal activity trackers (pat) provide objectively measured physical activity data and are more reliable than self-report. these devices can also have a motivational impact. the investigators intend to study the effects of these devices and their data on behavior change and weight loss for both parents and children enrolled in a cbfli program. the investigators will objectively measure the level of activity of both members of the parent-child dyad, explore the relationship between parent-child activity levels and its effect on each other, as well as on overall weight loss or weight maintenance.

Eligibility criteria:
inclusion criteria: * all individuals enrolled in bodyworks who are at least 7 years old meet inclusion criteria for this study. there is no maximum age for participation. exclusion criteria: unable to wear pat as described in study protocol unwilling to wear pat unwilling to participate in the study

Keywords: obesity pediatrics weight management program fitbit personal activity tracker
behavioral and pharmacologic treatment of binge eating and obesity: acute treatment

Conditions: Binge-eating Disorder; Obesity

Summary: this study will test the effectiveness and relative efficacy of behavioral and pharmacologic treatments, alone and in combination, for the treatment of binge eating disorder (bed) in patients with obesity. this is an acute treatment comparing behavioral weight loss alone or in combination with naltrexone/bupropion medication.

binge eating disorder (bed), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. improved treatments for obese patients with bed are needed that can produce sustained clinical outcomes and promote weight loss. this study (acute treatment stage) aims to test the effectiveness of behavioral weight loss (bwl) and pharmacological treatment with naltrexone/bupropion (nb; a recently fda-approved anti-obesity combination medication), alone and in combination, for the treatment of bed in patients with obesity. the acute treatment stage stage rct will provide new findings regarding the effectiveness of nb medication and whether this specific combination of bwl and nb medication is effective for patients with obesity and bed. n=160 patients with bed and obesity will be randomly assigned (double-blind) in a balanced factorial (2 x 2) design trial, to one of four 16-week interventions: bwl+nb, bwl+placebo, nb, or placebo. this study will produce important new information about the relative efficacy of bwl and this recently fda-approved anti-obesity (nb medicine), alone and in combination, for bed in patients with obesity.

Eligibility criteria:
inclusion criteria: * binge eating disorder (full criteria as described in the american psychiatric association diagnostic and statistical manual of mental disorders, 5th edition) * bmi 27-30 with a controlled obesity-related co-morbidity; or bmi ≥ 30 and \<50; * available for the duration of the treatment and follow-up (20 months); * read, comprehend, and write english at a sufficient level to complete study-related materials; * able to travel to study location (new haven, ct) for weekly visits. exclusion criteria: * currently taking anti-depressant medications; * currently taking opioid pain medications or drugs; * currently taking medications that influence eating/weight; * history of seizures; * current substance use disorder or other severe psychiatric disturbance (e.g., suicidality); * past or current anorexia nervosa, bulimia nervosa; * pregnant or breastfeeding; * medical status judged by study physician as contraindication.
comparison of intravenous anesthetics to volatile anesthetics on postoperative cognitive dysfunction

Conditions: Intra-abdominal and Intrapelvic Surgery

Summary: post-operative cognitive dysfunction (pocd) is a fairly well-documented clinical phenomenon. most patients will receive general anesthesia during surgery. two groups of general anesthetics are used for this purpose. we hypothesize that the incidence of pocd is not different in patients received intravenous anesthetics only or sevoflurane (a volatile anesthetic-based general anesthesia) for their major intra-abdominal surgery.

patients who are 60 years old or older for laparoscopic abdominal surgery will be randomly assigned into two groups: 1) sevoflurane-based general anesthesia group, and 2) propofol-based general anesthesia group. each group will need 221 patients to detect 1/3 of decrease or increase in the rate of pocd of one group compared with another group at about one week after surgery, assuming the overall rate of pocd at this time is about 40% at this time. considering about 10% loss to follow-up, we will have 250 patients in each group. in addition, investigators will need 184 subjects in the control group. the data of these control subjects will be used to normalize the data of the two studied groups to diagnose pocd. the subjects in control groups will also be elderly but without the exposure to anesthesia and surgery.

Eligibility criteria:
inclusion criteria: 1. major elective gastrointestinal, gynecological, prostate or bladder surgery patients who are ≥ 60 years old. 2. the surgery is laparoscopic surgery and is expected to last for ≥ 2 hours under general anesthesia and the patient will stay in hospital for at least 7 days after surgery. 3. lack of serious hearing and vision impairment and be able to read so that neurobehavioral tests can be performed. exclusion criteria: 1. patients are not expected to be alive for longer than 3 months. 2. mini-mental state examination (mmse) \[18\] score ≤ 23. 3. history of dementia, psychiatric illness or any diseases of central nervous system. 4. current use of sedatives or antidepressant. 5. alcoholism and drug dependence. 6. patients previously included in this study (for patients who have second intra-abdominal surgery during the study period). 7. difficult to follow up or patients with poor compliance. 8. uncontrolled hypertension (\> 180/100 mmhg)
self operating of the adi insulin pump by intended users - a usability study

Conditions: Diabetes Mellitus

Summary: diabetes mellitus (dm) is a multisystem disease with both biochemical and anatomical consequences. insulin pump therapy (continuous subcutaneous insulin infusion \[csii\]) is an attractive way of treating patients with diabetes. the nilimedix adi insulin pump is an ambulatory, battery operated, rate programmable micro infusion pump, designed for continuous delivery of insulin. insulin pumps require extensive user interaction because it is critical for treatment. avoidance of use-related risks that could harm the patient or impact the quality of the treatment is important. testing for ease and accuracy of use is the only way to ensure that users can safely and effectively operate, install, and program and maintain the insulin pump device.

this usability study was designed in order to test independent home use and device interface effectiveness of the nilimedix adi insulin pump, in order to validate safe and effective use by intended users. the study objectives are as following: * validate the safe and effective use while using the adi insulin pump by intended users. this objective will be assessed by carrying out list of tasks (operating the device, programming the appropriate flow rate and volume-to-be-infused parameters, and reacting to hazard massages) independently and successfully. * evaluate user's satisfaction. study design orientation, consent, and pre-test questionnaire participants will receive a short, scripted verbal orientation explaining the purpose of the usability test. prior to any study related procedures participant will provide written informed consent. performance evaluation the performance evaluation will consist of a list of tasks that participants will attempt to complete. the tasks were designed to explore the usability concerns. participants will be provided with the adi insulin pump and the user manual. all participants will be guided by the investigator how to use the adi insulin pump independently, how to read and interpret the display readings, how to program the device including insulin basal and bolus settings as well as how to maintain the device. in addition, participants will be given sufficient time to read carefully the user manual. after ensuring that the participant has perceived the directions for use he will be asked to operate the adi insulin pump by performing list of tasks. all tasks will be conducted by the participants independently. the investigator will not guide the subject during this phase- unless the subject asked him to.

Eligibility criteria:
inclusion criteria: * male/female age 18 years and up. * subject is diagnosed as a diabetic, or subject is parent/guardian of a diabetic child age under 18 years. * subject understands the study procedure. * subject is able to read the user manual. * signed informed consent form * compliance with study requirements. exclusion criteria: * major physical, motor, mental, behavioral, or psychiatric limitations. * concurrent additional major illness. * subject objects to the study protocol.

Keywords: insulin pump
survival in patients older than 60 years with newly diagnosed aml in spain

Conditions: Leukemia, Myeloid, Acute

Summary: prospective, multicenter, observational, national study (epa-sp) that aims to describe the survival and the quality of life, the clinical management strategies and the prognostic factors for survival related to the patient, in a prospective cohort of patients over 60 with aml diagnosis in spain and treated outside of clinical trials; that is, under conditions of standard clinical practice. the study will last 24 months in total from the inclusion of the first patient until the end of the last patient's follow-up

following the baseline enrolment visit, the following data corresponding to the patient's visits scheduled according to routine clinical practice will be collected in accordance with the following model: 1. recruitment period: one year of recruitment period, data collection at the baseline visit, every 3 months in one year (month 3, 6, 9 and 12). 2. follow-up period: data collection at the baseline visit, every 3 months in one year (month 3, 6, 9 and 12). the patient clinical history and the study´s questionnaires will be the source documents. the study will be carried out in the facilities of the hematology and hemotherapy services of the participating centers, collecting the conditions of medical action according to the standard clinical practice. being an observational study, no intervention out of standard clinical practice will be performed. no additional diagnostic or treatment procedures will be applied for the patients.

Eligibility criteria:
inclusion criteria: * patient of both sexes, aged 65 years and older. * any race, nationality or socioeconomic status. * aml (defined according to who 2016 criteria de novo, with previous hematological history or secondary. * diagnosis date later than 1st november 2017 and later than each center activation date. * patients on first line treatment with any therapeutic strategy (intensive, attenuated or palliative). * having given informed consent prior to start the data collection. exclusion criteria: * inability to understand the informed consent form. * aml previously treated (with or without hsct). * acute promyelocytic leukemia. * participation in a clinical trial that includes first-line treatment for aml. * do not grant consent.

Keywords: acute myeloid leukemia (aml) observational standard clinical practice survival tolerability spain
effect of therapeutic touch on functional constipation in infants and young children

Conditions: Functional Constipation; Therapeutic Touch; Infants; Children; Constipation

Summary: the aim of the study is to determine the effect of therapeutic touch on functional constipation in infants and young children.

functional constipation (fk) is a common functional gastrointestinal disorder that affects children's quality of life. the reported prevalence of functional constipation in infants and young children varies according to diagnostic criteria between studies. laxatives and probiotics are commonly used to treat functional constipation. therefore, treating constipation is very costly and there is not enough reliable data on this subject. when the literature is examined, the use of non-pharmacological methods to reduce, prevent and eliminate constipation has been increasing recently. when the studies were examined, studies using different methods were found. the main methods used in the care of children with constipation are; massage, aromatherapy, probiotics, laxatives, reflexology and acupuncture. the effect of therapeutic touch is thought to have positive results, especially in newborns, infants and children.based on the studies conducted in line with the literature, this research has a randomized controlled experimental design to determine the effect of therapeutic touch applied to infants and children diagnosed with functional constipation according to rome iv criteria on constipation. this study is a prospective, randomized and controlled trial. the study population consisted of infants and children aged 6 to 24 months. sample of the study consisted of a total of 60 children who met the sample selection criteria and were selected via randomization method. children were randomized into two groups: intervention gorup (n=30) and control group (n=30). data were collected using the interview and observation form, primary results follow-up form, and bristol stool form scale.

Eligibility criteria:
inclusion criteria: * the infant is between 6-24 months, * the infant was born at term, * birth weight between 2500-4500 g, * must have been diagnosed with functional constipation by the physician according to roma iv criteria, * mothers' ability to read, write and speak turkish, * parent's willingness to participate in the research. exclusion criteria: * the infant has a congenital anomaly, * the infant has any chronic disease, * having a secondary disease that causes constipation such as cow's milk allergy, celiac disease, hypercalcemia and hypothyroidism, neurological diseases,children with any organic or metabolic diseases * the parent has a verbal and written communication barrier.

Keywords: therapeutic touch functional constipation infants children
role of pressure bio feedback in management of forward head posture for computer users at bumdc

Conditions: Forward Head Posture

Summary: objective: the aim of present study is to explore the effectiveness of pressure bio feedback in treatment of occupational forward head posture on computer users.

material \& methods: this randomized control trial was conducted in bahria university college of physical therapy, karachi. ethical approval was prior taken from institute review board. there were 32 participants selected randomly equally in experimental and control group. both male and female were included with age of 25 to 55 years currently employees of bahria university (bumdc) having forward head posture or complaining neck pain were included. exclusion was age less than 25 years, history of cervical trauma or surgery, any neurological conditions or cervical pathology. experimental group was given dcf exercises with pressure biofeedback unit (pbu) and control group was given conventional dcf exercises. spss version 23.0 was used for analysis.

Eligibility criteria:
inclusion criteria: - both male and female age of 25 to 55 currently employees of bahria university (bumdc) having forward head posture complaining neck pain. exclusion criteria: * students of bahria university history of cervical trauma or surgery any neurological conditions or cervical pathology

Keywords: bio feedback deep cervical flexor neck pain forward head posture neck disability index
muscle relaxation for short procedures

Conditions: Intubating Conditions; Fasciculations; Postoperative Myalgia; Patient Satisfaction; Sore Throat

Summary: succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. a more modern alternative is the application of low-dose rocuronium, reversed by low-dose sugammadex. the investigators compare the intubating conditions, incidence of postoperative myalgia (pom), as well as patient satisfaction for these two muscle relaxants.


Eligibility criteria:
inclusion criteria: * age \> 18 yr * scheduled for elective rigid bronchoscopy exclusion criteria: * known neuromuscular disease * significant hepatic or renal dysfunction * family history of malignant hyperthermia * known allergy to one of the drugs used in this protocol * pregnancy or breastfeeding

Keywords: succinylcholine rocuronium sugammadex intubating conditions short procedures
the effect of nasal carbon dioxide (co2) in the treatment of seasonal allergic rhinitis

Conditions: Seasonal Allergic Rhinitis

Summary: the purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the treatment of seasonal allergic rhinitis

this multi-center, randomized, double-blind, placebo-controlled, parallel group trial will evaluate the efficacy and safety of a nasal, non-inhaled administration of carbon dioxide (co2) in patients with seasonal allergic rhinitis. an estimated 500 patients who meet the eligibility criteria will be enrolled into this study at approximately 25 sites to ensure that approximately 400 patients are randomized and complete the study.

Eligibility criteria:
inclusion criteria: * able to read and understand informed consent and voluntarily consent to sign the informed consent form * able to comply with the requirements of the protocol (e.g., complete the diary within the protocol-specified window) * minimal 2-year history of fall seasonal allergic rhinitis requiring pharmacotherapy * positive skin test to one or more fall seasonal allergen (e.g., ragweed, birch pollen, etc.) * females of childbearing potential must commit to using an acceptable method of birth control and have a negative pregnancy test exclusion criteria: * history of asthma (other than mild intermittent) * acute or significant sinusitis or upper respiratory infection within 14 days of enrollment * existing serious medical condition (e.g., severe emphysema) that precludes participation * females who are pregnant or breast-feeding and/or who plan to become pregnant or to breast-feed during the study participation or within 7 days after the last study drug administration * initiation of immunotherapy or have a change in immunotherapy dose within the 6 months preceding enrollment (if on immunotherapy, the same dose must be maintained throughout the trial) * planned travel outside the study area for the duration of study period * participation in another clinical study within 30 days of planned enrollment date and for the duration of the study * participation in a previous study with nasal co2

Keywords: randomized double-blind multi-center placebo-controlled phase ii nasal carbon dioxide carbon dioxide efficacy safety total nasal symptom score rqlq
non-interventional study about treatment of hemorrhages in thyroid surgery with tachosil®

Conditions: Hemorrhage

Summary: considering the total number of thyroid procedures in germany (100000 - 120000 cases per year), tachosil® is a valuable tool to support surgical haemostasis, avoiding lymph leaks and support speech-nerve saving approaches. the aim of this study was to evaluate a patient and procedure profile where tachosil® is most beneficial.


Eligibility criteria:
main inclusion criteria: * patients undergoing total or subtotal thyroidectomy main exclusion criteria: * contraindications, such as hypersensitivity to the active pharmaceutical ingredient or to another ingredient

Keywords: tachosil thyroid parathyroid fleece-bound hemostasispathologic processes hemorrhage thyroid surgery
ribavirin for patients with recurrent/metastatic (r/m) human papillomavirus (hpv)-related malignancies

Conditions: Human Papillomavirus (HPV)-Related Malignancies; Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies

Summary: the purpose of this study is to find out the effects, both good and bad, that a drug called ribavirin has on the patient and the cancer. ribavirin has also been studied in clinical trials for patients with various types of cancer. these studies demonstrated that ribavirin can be safely given at higher doses than the dosing that is used as part of the treatment of hepatitis c. ribavirin is known to target a protein called "4e" that turns on a central part which causes the cell to grow, called the ribosome. hpv-related cancers often have abnormally high levels of 4e. the purpose of this study is to evaluate if ribavirin may be a useful treatment for patients with advanced cancers that are related to hpv by blocking the activity of 4e.


Eligibility criteria:
inclusion criteria: * recurrent and/or metastatic hpv-related carcinoma of the cervix, anus, vagina, vulva, penis, or oropharynx. the cancer diagnosis must be confirmed by slide review in the mskcc department of pathology. hpv positive status must be demonstrated by hpv in situ-hybridization (ish) and/or by p16 immunohistochemistry (ihc). note: for cervix squamous cancer, hpv ish test or p16 ihc test is not required, because all cervix squamous cancers are presumed to be hpv-associated. * adults (≥ 18 years of age) * ecog performance status of 1 or better * measurable disease according to recist 1.1 criteria * availability of archived tumor tissue for correlative studies (5 unstained slides) * adequate organ function, as follows: * adequate bone marrow reserve: absolute neutrophil count (anc) ≥ 1.5 x 109/l, platelets ≥ 160 x 109/l, hemoglobin ≥ 10 g/dl * hepatic: total bilirubin within uln (upper limit of normal); alkaline phosphatase (ap), aspartate transaminase (ast) and alanine transaminase (alt) ≤ 2.0 x uln * renal: serum creatinine ≤ 1.3 mg/dl. patients with serum creatinine \> 1.3 mg/dl may be eligible if creatinine clearance (crcl) ≥ 55 ml/min based on the standard cockroft and gault formula. * ability to swallow oral medication. * patients of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. patients must agree to use a reliable method of birth control during and for 6 months following the last dose of study drug. * at least one prior systemic therapy regimen for r/m hpv-related carcinoma exclusion criteria: * history of hemolytic anemia or thalassemia * current treatment or known prior treatment with ribavirin * active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment. * current therapeutic anticoagulation with coumadin (warfarin) * known brain metastases

Keywords: ribavirin human papillomavirus (hpv) recurrent/metastatic (r/m) 14-211