Kornimate/medical-research-clean huggingface dataset:
a study of internet delivered parent child interaction therapy

Conditions: Disruptive Behavior

Summary: the purpose of this study is to learn more about how feasible remote parent child interaction therapy (pcit) is for children with disruptive behaviors and how to augment treatment with wearable devices.

children with disruptive behaviors aged 3-7 will wear a garmin watch throughout the course of the study (approximately 12 weeks). artificial intelligence (ai) will be applied to analyze the vitals provided by the watch to monitor for disruptive behavior. parent and child will be enrolled in remote pcit sessions throughout the course of the trial. this study will not require any in person visits, all materials will be mailed to the patients home or sent electronically. the study will analyze how the use of a wearable device throughout pcit will help increase the benefit to both parent and child as measured by biometrics via garmin and by questionnaires preformed throughout the trial.

Eligibility criteria:
inclusion criteria - children (aged 3-7): * outpatients. * able to provide developmentally appropriate informed assent, and legal guardians able to provide informed consent. * ebp severity rated above the clinically significant range (≥120; t-score ≥ 60) (eyberg child behavior inventory- ecbi; eyberg \& pincus, 1999). * families approached for participation will be asked to commit to complete the treatment: * at least one primary caregiver and the identified child will have to be able to speak and understand english; * must have the ability, technology, and internet access for remote therapy/research visits. inclusion criteria - adults (any age): * agree to wear garmin watch. * able to provide informed consent. * able to speak and understand english. * has the ability, technology, and internet access for remote therapy/research visits. exclusion criteria - children: * formal diagnosis of severe intellectual disability, autistic spectrum disorder level 3, or a psychotic disorder for the child. * parents not consenting to the study. * parents or child is not able to adhere to the study protocol. * a child who is reasonable expected to be unable to tolerate wearing the garmin device for at least 70% of the time during the day and night 70% of the days during the treatment (12 weeks). this is based on the principal investigator's discretion. * unable to speak and understand english. * refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures. * children in foster care. * does not have the ability, technology, and/or internet access for remote therapy/research visits. * need for more intensive behavioral treatments such as er visit for behavioral dyscontrol or hospitalization will not be exclusionary or exit criteria. exclusion criteria - adults: * unable to speak and understand english. * refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.

Keywords: garmin watch artificial intelligence pcit telehealth technology decentralized trial
prebiotic fructans effect on 1-3 years constipated children's bowel habits

Conditions: Constipation

Summary: the aim of the study is to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on bowel function in young children.

the aim of the study is to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on bowel function in young children. it is a double-blind, randomized, placebo-controlled trial.this study plans to recruit into the group of 100 participants (at least 80 of them completed) in 2018-2020.the two groups for the study are product group (prebiotic fructans) and control group (placebo maltodextrin).duration of intervention is 6 weeks, including 2 weeks for run-in and 4 weeks for intervention.efficacy parameters are stool consistency (assessed with amsterdam infant stool scale),stool frequency, stool amount and stool color (assessed with amsterdam infant stool scale, treatment success, tolerance and acceptability).

Eligibility criteria:
inclusion criteria: 1. diagnosis of functional constipation following rome4 criteria. 2. subject is otherwise healthy at the time of pre-examination. 3. subject is aged 1-3 years at the time of pre-examination. 4. subject and caretaker are able and willing to follow the study instructions. 5. subject is suitable for participation in the study according to the investigator/physician/study personnel. 6. written informed consent is given by parent or legal guardian. exclusion criteria: 1. no legal guardian's command of any local language. 2. organic causes of defecation disorders incl. hirschsprung disease, spina bifida, hypothyroidism etc. 3. other metabolic or renal abnormalities or mental retardation (child's mental delay). 4. food allergies or intolerances. 5. using drugs (e.g. antibiotics) influencing gastrointestinal function (4 weeks before run-in, 6 weeks before intervention). 6. use of laxatives and labelled pre- and probiotics in the previous 2 weeks before the beginning of run-in (4 weeks before intervention) 7. subjects who are currently involved or will be involved in another clinical or food study

Keywords: prebiotic
effectiveness of virtual sfcamina study

Conditions: Chronic Fatigue Syndrome

Summary: the main objective of this study is to analyse the effectiveness of the virtual sfcamina multicomponent treatment program as coadjuvant of treatmentas- usual (tau) compared to tau alone. in this randomized controlled trial (rct), in addition to evaluating the clinical effects of virtual sfcamina treatment in the short- and long term.

this is a tree-arm rct focused on the safety and potential effectiveness of the multicomponent program virtual sfcamina as coadjuvant of treatmentas- usual (tau) vs. tau alone. * virtual sfcamina combines multicomponent approach based on pain neuroscience education (pne), therapeutic exercise, cognitive behavioural therapy (cbt) and mindfulness training. * the main hypothesis is that improvement on fatigue of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as kinesiophobia, fear avoidance and by individualized therapeutic exercise.

Eligibility criteria:
inclusion criteria: * meet the fukuda and holmes classification criteria for fatigue syndrome chronicle * age equal to or greater than 18 years * understand and agree to participate in the study * sign the informed consent exclusion criteria: * terminal clinical conditions or scheduled treatments that may interrupt the study follow-up.

Keywords: multicomponent treatment chronic fatigue syndrome pain neuroscience education therapeutic exercise cognitive behavioural therapy mindfulness randomized controlled trial
clear clinical study

Conditions: Hearing Loss

Summary: acute in-booth assessment of a new noise reduction algorithm with cochlear implant recipients.


Eligibility criteria:
inclusion criteria: 1. conventional ci subject aged twelve years of age or older, or hybrid subject aged 18 years or older 2. recipient of a ci500 series (ci512 or ci522) or ci24re series (ci24reh or ci422) cochlear implant 3. at least three months ci experience in ear to be assessed 4. at least three months experience with the cp810,cp920 or cp910 sound processor 5. fluent speaker in the local language used to assess clinical performance 6. open-set speech perception ability 7. use of or eligibility for hybrid acoustic component (hybrid population only) exclusion criteria: 1. unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the investigational device 2. unwillingness or inability of the candidate to comply with all investigational requirements 3. additional handicaps that would prevent or restrict participation in the audiological evaluations or that would affect the scientific integrity of the study.
multicenter study on the pathogenic germline gene variants of colorectal polyposis in china

Conditions: Colorectal Polyposis

Summary: patients suspected of adenomatous polyposis were included. the criteria used were more than 10 polyps observed under colonoscopy, and pathological confirmation of adenoma. clinical data and pedigree information were collected. the variants of 139 genes associated with different hereditary cancers and polyposis were screened by ngs, which was performed by genetron health on the hiseqx-ten sequencing platform.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of adenomatous polyposis; 2. enough samples (provide at least 5ml of peripheral whole blood) for germline variant detection exclusion criteria: genetic diagnosis of polyposis syndrome
efficacy of the quell wearable device for fibromyalgia

Conditions: Fibromyalgia

Summary: this study is designed for patients with primary fibromyalgia (fm) pain. the overall aim of the study is to determine the effect of the high frequency quell device to manage fm compared with a low frequency device. investigators hypothesize that those assigned to using the high frequency quell device will report reduced pain compared with those using the low frequency quell device; with those using the high frequency device also showing more improvement in sleep, mood, and level of activity. investigators also hypothesize that frequency of using the quell (increased tolerability and adherence) will be correlated with greater reduction in pain.

the quell is battery powered with rechargeable batteries and is strapped to participant's upper calf with a velcro band. it has been cleared by the fda for safety. it is designed to improve fibromyalgia by the principles of transcutaneous electrical stimulation of nerves much like a traditional transcutaneous electrical nerve stimulator (tens) unit. investigators expect to enroll approximately 130 subjects in this study. participants will be equally randomized to one of two experimental groups: high frequency quell group (n=65) or low frequency quell group (n=65). this study hopes to find out whether low frequency or high frequency stimulation is most useful among persons with fibromyalgia.

Eligibility criteria:
inclusion criteria: 1. have chronic pain related to fm for \> 3 months' duration 2. average 4 or greater on a pain intensity scale of 0 to 10 3. are able to speak and understand english 4. have a smartphone (android or iphone) exclusion criteria: 1. diagnosis of cancer or any other malignant disease 2. acute osteomyelitis or acute bone disease 3. present or past dsm-v diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder that would be judged to interfere with study participation 4. pregnancy 5. any clinically unstable systemic illness judged to interfere with treatment 6. a pain condition requiring urgent surgery 7. an active substance use disorder, such as cocaine or iv heroin use (positive on the mini international neuropsychiatric interview; m.i.n.i. v.5.0), that would interfere with study participation 8. have an implanted cardiac pacemaker, defibrillator, or other implanted device
long-term cardiac monitoring after cryptogenic stroke (cmacs)

Conditions: Stroke

Summary: atrial fibrillation (af) is a common and treatable cause of ischemic stroke, but it can be paroxysmal and asymptomatic, and therefore difficult to detect. patients with stroke routinely undergo 24 hours of continuous cardiac telemetry during hospitalization for stroke as a means of excluding af. small studies indicate that extending the duration of monitoring with portable outpatient telemetry devices detects more cases of af. however, these studies are small and lack control groups, and cannot demonstrate that prolonged cardiac monitoring detects more cases of af than routine clinical follow-up. the investigators therefore propose a pilot study to determine the feasibility of randomizing patients to prolonged cardiac monitoring or routine clinical follow-up. the investigators will enroll 40 consecutive adult patients seen at the university of california at san francisco (ucsf) neurovascular service with cryptogenic stroke or high-risk tia (abcd2 score 4 or greater). enrolled patients will be randomized in a 1:1 fashion. group a will be assigned to wear an ambulatory cardiac event monitor for 21 days. group b will be discharged home without a monitor and will serve as controls during routine clinical follow-up. the investigators' primary outcome will be feasibility, defined as more than 80% of randomized patients completing full clinical follow-up and more than 70% of cardiac monitoring if applicable. the investigators' secondary outcomes will be diagnoses of af at 90 days and 1 year and diagnoses of recurrent stroke at 1 year.


Eligibility criteria:
inclusion criteria: * age \> 18 years * seen at ucsf medical center for cryptogenic stroke or high-risk tia * onset of stroke or tia symptoms within the previous 60 days exclusion criteria: * definite small-vessel etiology by history or imaging * source found on vascular imaging of possible culprit vessels * source found by echocardiography (tee not required) * history of atrial fibrillation * atrial fibrillation on admission ecg * atrial fibrillation detected by inpatient cardiac telemetry (at least 24 hours required) * obvious culpable systemic illness such as endocarditis * patient unable to provide written, informed consent

Keywords: stroke cryptogenic cardioembolic atrial fibrillation
a study to assess the efficacy and safety of debio 4126 in participants with acromegaly previously treated with somatostatin analogs

Conditions: Acromegaly

Summary: the primary purpose of this study is to assess the effect of debio 4126 in the maintenance of the levels of insulin-like growth factor 1 (igf-1) ≤1x upper limit of normal (uln) in the double-blind period (period 1) in comparison to placebo at week 36.


Eligibility criteria:
inclusion criteria 1. patients ≥18 years of age 2. patients who are receiving octreotide or lanreotide monotherapy for acromegaly for at least 6 months, at a stable dose for the last 12 weeks. 3. igf-1 at screening ≤1x uln 4. acromegaly diagnosis, defined as per protocol 5. adequate bone marrow, hepatic and renal function 6. to enter period 2 (arms a and b): igf-1 ≤1x uln at week 34, or up to week 48 when treated with rescue medication 7. other protocol-defined criteria apply exclusion criteria 1. compression of optic chiasm causing visual defects 2. symptomatic cholelithiasis or bile duct dilatation 3. planned cholecystectomy during the trial duration 4. acute or chronic pancreatitis 5. pituitary radiotherapy 6. uncontrolled hypothyroidism 7. uncontrolled diabetes 8. pituitary surgery within 6 months before screening or planned on trial 9. treatment with pasireotide within 6 months prior to screening, pegvisomant or dopamine agonists within 3 months prior to screening 10. recent or ongoing cardiovascular or thromboembolic diseases including heart failure, myocardial infarction, stroke, certain arrythmias, pulmonary embolism 11. other protocol-defined criteria apply

Keywords: igf-1 growth hormone pituitary gland gigantism
placental growth and adverse pregnancy outcomes

Conditions: Hypertension Induced by Pregnancy; Pre-Eclampsia; IUGR

Summary: the purpose of this study to determine if measurement of maternal serum biomarkers and evaluation of the placenta by ultrasound can improve prediction of adverse pregnancy outcomes.

the placenta is known to play a vital role in maintaining a healthy pregnancy. placental dysfunction is believed to be a driving factor in a variety of adverse obstetric outcomes, including fetal growth restriction and preeclampsia. advances in 3d ultrasound have allowed for measurement of placental volumes during pregnancy. it may be that quantitative assessment of early placental growth can help identify pregnancies at risk for adverse outcome. furthermore, various novel serum analytes have been proposed as predictors of adverse outcome. the investigators seek to prospectively measure placental volume and diameter at 11-14 weeks and 18-24 weeks to determine if placental growth can predict adverse outcome. in addition, the investigators seek to investigate the relationship between placental growth and serum levels of various biomarkers to see if improved detection of adverse outcome can be achieved.

Eligibility criteria:
inclusion criteria: * all singleton gestations presenting for sequential screen testing at hup * patients competent to provide verbal informed consent exclusion criteria: * multiple gestations * patients not competent to provide informed consent * patients found to be too late for the sequential screen * pregnancy losses 20 weeks gestation * major fetal anomalies * patient delivering outside of the uphs
rifaximin for infection prophylaxis in hematopoietic stem cell transplantation

Conditions: Microbial Colonization

Summary: primary purpose of the study is to see if rifaximin can improve the balance of bacteria within the gut, which has been shown to improve transplant outcomes. it will also assess whether rifaximin can reduce the risk of infection in blood/marrow transplant (bmt).

this study is for patients who will be having a blood/marrow transplant (bmt) to treat leukemia, lymphoma or other cancer of the blood. the blood or marrow cells will come from another person (donor)-allogeneic bmt. bacterial infections and acute graft versus host disease (agvhd) are frequent complications of allogeneic bmt. bacterial infections sometimes happen because injury to the gut during transplant allows gut bacteria to cross the injured gut barrier and get to the blood. agvhd happens when certain white blood cells, called t-cells, in the donor cells (the graft) attack the patient's body. primary purpose of the study is to see if rifaximin can improve the balance of bacteria within the gut, which has been shown to improve transplant outcomes. it will also assess whether rifaximin can reduce the risk of infection in blood/marrow transplant (bmt).

Eligibility criteria:
inclusion criteria: 1. allogeneic hsct recipients between the ages of 2 and 21 years. 2. underlying hematologic malignancy, regardless of donor type or graft source. 3. myeloablative conditioning regimen. exclusion criteria: 1. known hypersensitivity to rifaximin, or other rifamycin antimicrobial agents. 2. minimally toxic conditioning regimen (e.g. low dose tbi based). since these regimens induce minimal myelosuppression and gut injury, patients receiving them probably stand little to gain from antibiotic prophylaxis. 3. patients with ongoing bacterial, viral or fungal active infections are not eligible for this study. patients who remain on broad spectrum antibiotics for the treatment of a previous infection are not eligible. 4. the use of prophylactic antibiotics is not permitted. 5. following the standard practice in blood and marrow transplantation, pregnant or breast feeding patients will be excluded

Keywords: rifaximin microbiome allogeneic hematopoietic stem cell transplantation blood stream infections acute graft versus host disease
diabetes mellitus community based screening in minority populations

Conditions: Type II Diabetes; Diabetes Mellitus

Summary: the purpose of the type ii diabetes (t2d) screening study is to improve diabetes care in minority communities by identifying undiagnosed and uncontrolled t2d patients, as well as help patients without a regular primary care physician (pcp) find one within their community. these goals will be achieved first through a glucose measurement. individuals with a high glucose measurement will be confirmed with a rapid hemoglobin a1c (hga1c) test. the hga1c test will tell us about the patients average blood sugar over the past 3 months, which will allow us to immediately diagnose new and uncontrolled type ii diabetics. all participants will fill out a survey on healthcare seeking behaviors before glucose testing. all patients who enter the study will receive education on t2d and the value of regularly visiting their pcp, and will be provided a list of pcp currently accepting new patients within a 3 mile radius. follow-up visits at 4 and 8 months will help us determine the success this community based screening. the investigators hypothesis is that community based screening designed with adequate education and follow-up, and performed by qualified medical professionals will improve diabetes care in minority communities as assessed through hemoglobin a1c levels over 8 months, and in the change in the number patients who visit/obtain their pcp within the study period.


Eligibility criteria:
inclusion criteria: * adults 18 and older exclusion criteria: * type i diabetes. * women who are currently pregnant.

Keywords: type ii diabetes minorities diabetes mellitus community based screening
traditional dietary advice versus a low fodmap diet intake in ibs patients

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to to assess if the new diet with a low-fodmap(fermented oligo-, di-, monosaccharides and polyols) -content yields a milder symptom picture in ibs patients compared to traditionally dietary advice in ibs. the study also aim to investigate patients compliance to either dietary advices. further, the investigators aim to find out if ibs patients with different symptoms are alleviated in different ways, to be able to individualize the dietary advices to result in a more optimal symptom relief in each patient in the future.


Eligibility criteria:
inclusion criteria: * ibs diagnosis * adult (over 18 years) * be able to read/understand/write swedish exclusion criteria: * severe heart failure * severe liver disease * severe neurologic disease * severe psychological disease * severe gastrointestinal disease (i.e. celiac disease, ibd (inflammatory bowel disease) e.g.)

Keywords: defecation abdominal pain