Kornimate/medical-research-clean huggingface dataset:
genetic predisposition to food cue reactivity in children

Conditions: Childhood Obesity

Summary: this study assesses the associations between genetic factors, food-cue-related neural reactivity, self-regulatory capacity, eating in the absence of hunger (eah), and adiposity gain in children.

the investigators will assess the associations between genetic factors, food-cue-related neural reactivity, eating in the absence of hunger (eah) in response to food cues, and adiposity gain in children. they will also determine whether self-regulatory capacity modifies these associations. the genetic factors explored specifically include fto, mc4r, polymorphisms in genes involved in dopaminergic pathways, and a composite genetic risk score built from genome-wide obesity-related loci. \[3/14/2020\]: study recruitment temporarily halted due to the covid-19 pandemic

Eligibility criteria:
inclusion criteria: * english fluency * willingness to participate in all study visits exclusion criteria: * relevant food allergies or dietary restrictions * metal in or on the body * claustrophobia * psychiatric and neurological disorders * relative in the study * appetite- or attention-altering medications or disorders

Keywords: obesity cue reactivity genetics self regulation fmri children eating in the absence of hunger
the effect of patient education on opioid consumption

Conditions: Rotator Cuff Injury

Summary: prospective, randomized clinical trial investigating the use of patient education on post-operative narcotic consumption


Eligibility criteria:
inclusion criteria: * over the age of 18 * clinically indicated for an arthroscopic rotator cuff repair exclusion criteria: * patients with irreparable rotator cuff tears * allergic or sensitivity to the study medication * history of gastrointestinal issues * any evidence of glenohumeral arthritis * inability to consent
efficacy of home blood pressure monitoring (monitor study)

Conditions: Hypertension

Summary: high blood pressure is the main risk factor for cardiovascular disease worldwide,but its control rate is unsatisfactory. home blood pressure monitoring (hbpm) with automatic oscillometric devices and pharmaceutical care have been proposed as interventions to increase therapeutic compliance and to guide treatment decisions. the purpose of this study is to evaluate the effect of hbpm and of pharmaceutical care in blood pressure control measured through 24h ambulatory blood pressure monitoring (abpm).

home blood pressure monitoring (hbpm) and pharmaceutical care have been proposed to improve therapeutic compliance and to guide treatment decisions, but their effects on bp control are still under debate. this is a factorial randomized controlled trial including adult hypertensive patients under drug treatment but with office bp and 24h abpm uncontrolled. participants will be allocated to one of four groups: hbpm; hbpm and pharmaceutical care; pharmaceutical care; or control. all participants will receive usual care for high blood pressure. participants will be followed for 60 days.

Eligibility criteria:
inclusion criteria: * office bp ≥140/90 mm hg * 24h abpm hypertension bp ≥130/80 mm hg * using at least one antihypertensive drug exclusion criteria: * bp ≥ 180 / 110 mmhg) * major cardiovascular events in the last six months * acute or chronic diseases limiting the capacity to understand and to participate in the trial * masked hypertension * white-coat hypertension * secondary hypertension * pregnancy * breastfeeding * concurrent participation in another trial

Keywords: hypertension blood pressure home blood pressure monitoring ambulatory blood pressure monitoring pharmaceutical care
strattice in repair of inguinal hernias

Conditions: Hernia, Inguinal

Summary: this is a prospective, randomized, controlled, third-party blinded, multicenter, interventional evaluation of inguinal hernia repair comparing strattice to light weight polypropylene mesh. performance and outcomes measures to be compared include postoperative resumption of activities of daily living, nature and incidence of short- and long-term pain and complications, and incidence of hernia recurrence.


Eligibility criteria:
inclusion criteria: * adult male * symptomatic and palpable inguinal hernia * open, elective, primary unilateral inguinal hernia repair exclusion criteria: * bilateral inguinal hernia repair * bmi \>35 * chronic immunosuppression, active chemo/radiation therapy, uncontrolled diabetes, severe liver disease or copd * chronic prostatitis, orchitis, testicular pain * local or systemic infection at time of repair * known collagen disorder * chronic pain syndrome or under active pain management

Keywords: surgical mesh inguinal hernia repair chronic groin pain
open label immunotherapy trial of inoperable pancreatic cancer

Conditions: Pancreatic Cancer Non-resectable

Summary: pancreatic cancer (pda) is the most lethal form of cancer, and the fourth-leading cause of cancer-related death in the united states, with a survival rate of less than 7%.there are currently no treatments found to be effective for patients with advanced disease who are ineligible for surgery, a prognosis representing the majority of pancreatic cancer diagnoses. pancreatic cancer is not amenable to chemotherapy as compared to other cancer types, leaving patients with practically no options except surgery. we have made oral tableted therapeutic vaccine, v3-p, derived from pooled blood of patients with pda in line with similar highly promising approach we have adopted for patients with hepatocellular carcinoma (hcc) and cholangiocarcinoma (caa). patients with pda will be given one tablet per day of v3-p and followed up to see the outcome.

this study is an open label phase ii study aimed to recruit at least 20 patients with inoperable pda and who are positive for ca19.9 pancreatic tumor marker. the presence of higher than normal levels of ca19.9 is the sole inclusion criteria. patients will be given one tablet of v3-p daily and followed for three months.

Eligibility criteria:
inclusion criteria: * diagnosis of inoperable pancreatic cancer * higher than normal of serum ca19.9 tumor marker levels (40 iu/ml) * must be able to swallow tablets exclusion criteria: * negative for ca19.9 * pregnant, breast feeding women * unwillingness to provide written consent
dimethyl fumarate (dmf, tecfidera®) persistence in rr-ms patients included in the french patient support program orosep

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the primary objective is to compare oral dimethyl fumarate (dmf) persistence at six months in relapsing-remitting multiple sclerosis (rr-ms) participants initiating dmf with and without orosep patient support program (psp), respectively. the secondary objectives are: to compare oral dmf persistence at one month and three months in rr-ms participants initiating dmf with and without orosep psp, respectively; to compare oral dmf adherence at six months in rr-ms participants initiating dmf with and without orosep psp; to compare at three months and six months the reason of oral dmf discontinuation, in the two groups; to describe the percentage of participants with treatment-related adverse events globally and by class of adverse events, in the two groups of participants; to assess the evolution of participants' anxiety globally and to compare it at inclusion and at six months in participants with and without orosep psp, respectively; to describe participants' satisfaction regarding oral dmf initiation and follow-up globally at six months and to compare it in patients with and without orosep psp, respectively; for orosep psp group: to assess participants' satisfaction regarding their participation in orosep psp at six months; to assess neurologists' satisfaction regarding their participation in orosep psp, after the last participant last visit of center.


Eligibility criteria:
key inclusion criteria: * ability to understand the purpose and risks of the study and giving oral informed consent regarding tec-adhere study and authorization to use protected health information (phi) in accordance with national and local participant privacy regulations; * diagnosis of rr-ms; * initiating oral dmf according to summary of product characteristics (smpc) at the inclusion visit; * expanded disability status score (edss) under 6. key exclusion criteria: * participants with progressive form of multiple sclerosis (ms); * with memory or psychiatric disorders preventing them to complete questionnaires in the study. note: other protocol defined inclusion/exclusion criteria may apply.
residence time evaluation of marketed otc ophthalmic products

Conditions: Dry Eye

Summary: the objective of this study is to measure ocular surface residence time (in minutes) of two marketed otc ophthalmic products in dry eye patients.


Eligibility criteria:
inclusion criteria: * informed consent and hipaa read, signed and dated before conducting any procedures. * adult volunteers diagnosed with mild to moderate dry eye. criteria for diagnosis must include 2 of the 3 following characteristics: composite symptom score \> or = to 5 on modified schein questionnaire; nafl tfbut \ or = to 3 (using 0-15 point grading system). * able and willing to follow study instructions. 4) best-corrected v.a. of 0.6 logmar or better ou. exclusion criteria: * history or evidence of ocular or intraocular surgery in either eye w/i the past 6 months. * history or evidence of serious ocular trauma in either eye w/i the past 6 months. * history of intolerance or hypersensitivity to any component of the study medications. * history or evidence of epithelial herpes simplex keratitis, vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva and/or eyelids, mycobacterial infection of the eye, and/or fungal disease of the eye. * use of concomitant topical ocular medications during the study period. * patients using systemic medications that may contribute to dry eye may not be enrolled unless they have been on a stable dosing regimen for a minimum of 30 days prior to visit 1, and the dosing regimen must remain stable throughout the study period. * ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe admininstration of the test article. * individuals unwilling to d/c contact lens wear during the study period. cl wear must have been d/c at least one week prior to visit 1. * participation in an investigational drug or device study w/i 30 days of entering this study. * additionally, any subject may be declared ineligible for a valid medical reason.

Keywords: dry eye autofluorescence residence time
management of popeye sign with botulinum toxin after bicepstenotomy

Conditions: Popeye Syndrome

Summary: double-blinded randomized controlled trial with 20 people of whom 10 will receive a placebo infiltration and 10 an infiltration with botulinum toxin type a for cramping pain after arthroscopic tenotomy of the long head of the biceps tendon.

title: management of popeye sign with botulinum toxin after tenotomy of the long head of the biceps tendon: a double-blinded randomized controlled trial précis: double-blinded randomized controlled trial with 20 people. randomization in 2 arms of 10 people. 3 visits will be planned with a meantime of 3 months after the infiltration with botulinum toxin type a (btx-a) or placebo that will be administered at the 2nd visit. objective: the primary objective is to assess the effectiveness of an infiltration with botulinum toxin in the biceps muscle after tenotomy of the long head of the biceps tendon for pain and disability reduction. endpoint: the primary endpoint is a pain reduction as measured by the visual analogue pain scale (vas) and a reduced disability as measured by the quick dash (disabilities of the arm, shoulder and hand). population: 20 people who underwent an arthroscopic tenotomy of the long head of the biceps tendon and are having post-operative pain in the biceps muscle. phase: 4 number of sites enrolling participants: single center study in az delta roeselare description of study agent: botulinum toxin type a (botox®) 100 international units by intramuscular injection study duration: from march 2021 till december 2022 participant duration: 3 months

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * have had arthroscopic tenotomy of the long head of the biceps tendon without rotator cuff repair, acromioclavicular joint resection or glenoid labrum repair * having bicipital pain that started after the tenotomy exclusion criteria: * under 18 years of age * over 65 years of age * pregnancy or lactation

Keywords: tenotomy long head of the biceps tendon botulinum toxin
tranexamic acid to reduce bleeding in patients treated with new oral anticoagulants undergoing dental extraction

Conditions: Tooth Extraction

Summary: in patients treated with direct oral anticoagulants, bleeding events during or after tooth extraction can lead to unscheduled interruption of the antithrombotic treatment and a potential increased risk of thrombo-embolic events. therefore, an optimal strategy to minimize bleeding events after tooth extractions is required. in this study, the investigators want to assess whether adding tranexamic acid mouthwash reduces the number of bleeding events in patients treated with direct oral anticoagulants and undergoing a tooth extraction.

interventional phase iv, randomized, double-blind, placebo-controlled trial: * feasibility: a 3-day regimen of tranexamic acid mouthwash in patients treated with direct oral anticoagulants * efficacy: reduction of bleeding events after tooth extraction compared to placebo * safety: any non-oral bleeding or thrombo-embolic events

Eligibility criteria:
inclusion criteria: * patients scheduled for dental extraction and treated with edoxaban, apixaban, rivaroxaban or dabigatran * not having taken the direct oral anticoagulant on the day of the extraction * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study exclusion criteria: * subjects with any condition that as judged by the investigator would place the subject at increased risk of harm if he/she participated in the study. * pregnancy or lactation * known allergic reaction to tranexamic acid

Keywords: anticoagulants tranexamic acid
study of possible changes in qst after application of capsaicin on patients with peripheral neuropathic pain

Conditions: Peripheral Nerve Injury; Postherpetic Neuralgia

Summary: the treatment of neuropathic pain ist still a challenge. a new promising therapy is the use of capsaicin on skin. the investigators first experiences with capsaicin in patients with peripheral nerve injury showed changes in the sensibility, which achieved its maximal extent after four weeks and was regressive, but not completely abolished 1,5 months after application. in this study the investigators hope to specify, how long and in which way exactly this changes in sensibility appear.

the topical application of a high dosage of capsaicin (8%) is a new promising approach. there is only little knowledge about the extent and the duration of drug-induced changes of detection and pain thresholds based on a currently recommended standardized quantitative sensory testing (qst). the assessment of qst changes would be an important step forward to understand the way of action as well as the time course of the presumed recovering of the c-fiber function after topical application of a high concentration capsaicin patch. 10 patients suffering from peripheral neuropathic pain due to peripheral nerve injury and 10 patients suffering from postherpetic neuralgia will be investigated by qst following the protocol of dfns (german research network on neuropathic pain), using both thermal and mechanical nociceptive as well as non-nociceptive stimuli. qst will be performed at the following times: * at baseline * 2, 4, 6, 8 weeks later, and every two weeks at least until re-occurrence of pain and/or recovering of the capsaicin-induced worsening of the c-fiber function.

Eligibility criteria:
inclusion criteria: * age \>18 years with signed informed consent * with planned topical application of capsaicin (8%) and with no involvement in any other study * with neurological proved peripheral neuropathy (e.g. peripheral nerve lesion, postherpetic neuralgia) and with remaining moderate pain intensity under the current treatment (\> nrs 3; numeric rating scale 0-10) * some remaining sensory function at the baseline qst with z-scores ≥ - 3 for cold, warmth and tactile thresholds exclusion criteria: * with missing informed consent * with any contraindications for capsaicin application * with diabetes mellitus, * using lidocaine patch in the test area in the last 6 months before enrollment * with inadequate knowledge of the german language

Keywords: peripheral nerve injury postherpetic neuralgia pni phn capsaicin qst quantitative sensory testing sensory profile neuropathic pain
improving hiv prevention skills in people with serious mental illnesses

Conditions: HIV/AIDS

Summary: this study will evaluate the effectiveness of motivational interviewing plus skill building in reducing hiv risk behavior in people with serious mental illnesses.

people with serious mental illness (smi) are at higher risk for contracting hiv than the general population. although fewer people with smi are sexually active, as compared to the healthy population, those with smi who are sexually active tend to engage in sexual behaviors that put them at increased risk for hiv and other stds. the onset of smi, which often interferes with normal psychosocial development, may cause these behaviors. additionally, smi is frequently associated with poor judgment, affective instability, and impulsiveness. interventions designed to reduce the risk for contracting hiv in people with smi exist, but they have had little success. new approaches to treating this population are essential. this study will evaluate the effectiveness of motivational interviewing (mi) plus skill building (sb) exercises in reducing hiv risk behavior in people with smi. participants in this 6-month, open-label study are randomly assigned to partake in sb training either alone or combined with mi. the skill building program focuses on behavioral skills training, with an emphasis on negotiating and communicating with prospective partners. training includes information about hiv risk, including mechanisms of transmission, abstinence, and safer sex and drug use behaviors; hiv risk reduction strategies, including condom use, abstinence/safer sex negotiation skills, and reduced/safer drug use; and an opportunity to be tested for hiv if the participant has not already done so. the sb plus mi intervention (sb-mi) includes components of the sb intervention, as well as elements of mi. mi includes identifying high risk sexual and drug use behaviors related to hiv; reducing the ambivalence about making high risk behavior changes; increasing motivation to change high risk behaviors; and developing a plan to implement these changes. hiv testing may be included. participants in both interventions report to the study site on six to seven occasions over the course of the study. the visits last between 1 and 2 hours and include both treatment and evaluation. participants attend two follow-up visits, one 3 months after randomization, and one 6 months after randomization.

Eligibility criteria:
inclusion criteria: * meets criteria for a serious and persistent mental illness (as defined by the massachusetts department of mental health) * english-speaking * engagement in hiv risk behavior within 3 months prior to study entry * ability to keep study-related appointments exclusion criteria: * unstable mental status

Keywords: hiv aids prevention serious mental illness
safety & efficacy study evaluating the combination of bevasiranib & lucentis therapy in wet amd (carbon)

Conditions: Age Related Macular Degeneration

Summary: the purpose of this study is to compare the safety and effectiveness of three doses of intravitreal bevasiranib sodium as maintenance therapy for age-related macular degeneration following initiation of anti-vegf therapy with three doses of lucentis®.


Eligibility criteria:
inclusion criteria: * patients must be age 50 years or older * patients must have predominantly classic, minimally classic or occult with no classic lesions secondary to age related macular degeneration. * the study eye must have etdrs best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 snellen equivalent). * patients must be willing and able to return for scheduled monthly follow-up visits for two-years. exclusion criteria: * prior pharmacologic treatment for amd in the study (patients can not have previously received avastin®/lucentis®, macugen®, or any other anti-vegf agents, steroid treatments, pdt, radiation treatment, or any experimental therapies for amd in the study eye) * any intraocular surgery of the study eye within 12 weeks of screening * previous posterior vitrectomy of the study eye * advanced glaucoma or intraocular pressure above 22 mm hg in the study eye despite treatment.

Keywords: amd armd exudative macular degeneration bevasiranib sirna
a trial to evaluate the safety and efficacy of a fully degradable ventricular septal defect (vsd) closure

Conditions: Ventricular Septal Defect

Summary: the purpose of this clinical trial is to verify the safety and effectiveness of the fully absorbable vsd occlusion system and vsd occlusion system produced by shanghai shape memory alloy materials co., ltd. clinical trials are designed as prospective, multicenter, randomized controlled, noninferiority clinical trials. prospective randomized multicenter trial involving about 108 subjects will be enrolled in 4 centers. patients will be randomized to two groups in equal proportion (54 in each). the success rate of occlusion at 6 months after operation is the main evaluation index in this clinical trial.

1. this is a prospective, multicenter, randomized and noninferiority clinical trial, which is designed to compare the effectiveness and safety with the fully absorbable ventricular septal defect (vsd) occlusion system and vsd occlusion system produced by shanghai shape memory alloy materials co., ltd. 2. this trial will recruit about 108 subjects from 4 centers. patients will be randomized to two groups in equal proportion (54 in each). the proposal recruiting period is 12 months and the follow-up will be performed at 1 month, 3 months and 6 months after surgery.

Eligibility criteria:
inclusion criteria: 1. subjects and/or their legal guardians will be informed of the nature of this study and agree to participate in this clinical trial in accordance with all terms of this study.signed the informed consent approved by the ethics committee, agreed to accept the postoperative treatment program, and completed the follow-up and related examinations as required by the follow-up; 2. aged from 1 to 60 years old, weight more than 10 kg, male or non-pregnant women; 3. vsd effective shunt ≥3mm, ≤14mm; 4. distance between the edge of defect and the right aortic valve is more than 3mm, no aortic valve prolapse or moderate aortic regurgitation. exclusion criteria: 1. irreversible pulmonary vascular disease;severe pulmonary hypertension with bidirectional shunt; 2. bleeding disorders or known clotting disorders (including heparin-induced thrombocytopenia),contraindications to antiplatelet therapy, or rejection of transfusions; 3. sepsis or severe infection within 1 month prior to occlusion; 4. patients with thrombosis at the occluder placement and venous thrombosis at the catheter insertion site; 5. cardiac malformation dependent on ventricular septal defect (vsd); 6. not suitable for treatment with this product.

Keywords: vsd ventriculai septal defects amplatzer