Kornimate/medical-research-clean huggingface dataset:
pediatrician-lead motivational counselling to control bmi in overweight children: a rct in primary care

Conditions: Overweight

Summary: obesity is one of the leading causes of morbidity and mortality in the industrialised world. evidence is growing that early life nutrition can play a role in behavioural and cognitive problems in children and adolescents and is well documented that being overweight and obese during childhood can have short- and long-term physical and psycho-social health implications. this is an individually randomised trial to evaluate the efficacy of a family pediatrician-lead counselling intervention in reducing the bmi of over-weight children aged 4-7 years old. as secondary objectives the investigators evaluate the effect of the counselling on dietary behaviours and physical activity. the investigators targeted the intervention to overweight children, while obese children were referred to specialised care. the counselling targeted diet, physical activity, and sedentary behaviours.


Eligibility criteria:
inclusion criteria: * overweight children with bmi percentile between 85° and 94° * 4-7 years old * resident in reggio emilia province * assisted by the pediatrician at least for 12 months exclusion criteria: * metabolic pathologies and all pathologies related with obesity * family in pre-contemplation stage

Keywords: overweight obesity children bmi counseling pediatrician
the feldenkrais method for people with intellectual disability

Conditions: Intellectual Disability

Summary: loss of functioning and age-related health problems tend to appear earlier in individuals with intellectual disability (id) than in their non-disabled peers and due to this people with id who are in employment tend to need to retire earlier, producing social, economic and health problems. the feldenkrais method (fm) is a movement-based form of learning that enhances body balance and physical functioning. we hypothesized that the fm could be helpful to improve balance and functioning of employed people with id.

the aim of this study will be to determine the effects of a feldenkraisn method (fm) program in improving functionality and body balance in supported employed individuals with id. to evaluate this effect, a total of subjects will participate in a longitudinal and clinical trial. sample size has been calculated to detect minimal significant effects on the variable of physical performance (sppb): accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, 26 individuals are required in order to detect a difference equal to or greater than 1.5 unit in the sppb (sd= 1.94). it has been increased the sample size in an additional 20% (losts during follow-up) and 5% (mortality). the resultant sample size is determinate in 32 individuals, who are equally randomized in both experimental and control groups. statistical analysis was performed using ibm spss statistics for windows (version 22.0). data were presented as mean ± standard deviation. descriptive statistics were calculated for all outcome measures. mean differences within the groups in the functional tests and stabilometric outcomes were estimated using paired sample t-tests, while mean differences between the groups in these variables were estimated using repeated measures analysis of variance. differences were considered significant at p \ 0.01 and \< 0.06), moderate (≥ 0.06 and \< 0.14) or large (≥ 0.14).

Eligibility criteria:
inclusion criteria: * aged between 40 and 60 years old, with mild-moderate id and able to follow fm classes in a group exclusion criteria: * aged 40 or older than 60 years old, id not classified as mild-moderate and absence of capacity for following fm classes in a group

Keywords: intellectual disability feldenkrais method short physical performance battery stabilometry supported employment
the impact of supermicrosurgery intervention on patients with lower extremity lymphedema using groin-only approach lymphaticovenous anastomosis

Conditions: Lymphedema; Lymphedema of Leg

Summary: this study employs a propensity score-matched analysis to compare the treatment outcomes, focusing on percentage volume reduction between the conventional multi-incision lymphaticovenous anastomosis (lva) technique and the novel single groin incision lva technique in patients with unilateral lower extremity lymphoedema.

lymphaticovenous anastomosis (lva), a surgical technique that connects lymphatic vessels (lvs) to adjacent veins, has demonstrated efficacy in alleviating lymphedema by enabling the drainage of stagnant lymphatic fluid. conventional lva treatment for lower extremity lymphoedema (lel) has favored distal, multiple incisions in the lower leg due to the denser and more superficial distribution of lvs and recipient veins in the distal regions. based on the recent advancement in the understaning of lymphosomes and the role of antegrade lymph flow, a shift to more proximal lva around the groin region for lel could be theoretically advantagous, but its clinical efficacy compared to conventional distal lva remains underexplored.

Eligibility criteria:
inclusion criteria: * patients diagnosed with lymphatic-related diseases to the lower extremity * patients who is undergoing lva for unilateral lower-limb lymphedema. exclusion criteria: * primary lymphedema * bilateral lower limb lymphedema * history of previous treatment for lymphedema (lva, vascularized lymph node transfer (vlnt), liposuction, or excisional therapy such as the charles procedure) - those that were lost to follow-up. * patients who recieved both lva to the groin site and non-groin site.

Keywords: propensity score matching lva supermicrosurgery lymphaticovenous anastomosis lymphovenous bypass
gs-5885, gs-9451, tegobuvir and ribovirin in treatment-experienced subjects with chronic genotype 1a or 1b hepatitis c virus (hcv) infection

Conditions: Hepatitis C, Chronic

Summary: this is a phase 2 randomized, double-blind, placebo-controlled study of gs-5885, gs-9451, tegobuvir and ribavirin (rbv) compared with gs-5885, gs-9451 with tegobuvir or rbv in treatment-experienced subjects with chronic genotype 1a or 1b hepatitis c virus (hcv) infection.


Eligibility criteria:
inclusion criteria: * age ≥18 years with chronic hcv infection * liver biopsy results ≤ 3 years prior to screening indicating the absence of cirrhosis. alternatively, a non-invasive procedure conducted within 6 months of screening is permitted in countries where allowed * monoinfection with hcv genotype (gt) 1a or 1b * hcv rna ≥ 104 iu/ml at screening * prior treatment and adherence with one course of pegylated interferon alfa and rbv * the subject's medical records must include sufficient detail of prior treatment with pegylated interferon alfa and rbv (start/stop dates and viral response) to allow for categorization of prior response as either null, partial, breakthrough or relapse. * body mass index (bmi) 18-40 kg/m2 inclusive * screening ecg without clinically significant abnormalities and with qtcf interval (qt corrected using fridericia's formula) ≤ 450 msec for males and ≤ 470 msec for females. * agree to use two forms of highly effective contraception for the duration of the study and for 7 months after the last dose of study medication. females of childbearing potential must have a negative pregnancy test at screening and baseline. exclusion criteria: * discontinuation of prior treatment with pegylated interferon alfa and rbv due to an adverse event, toxicity reasons or were lost to follow-up * history of significant cardiac disease * exceed criteria delineated in section 4.2 for laboratory measure thresholds related to leukopenia, neutropenia, anemia, thrombocytopenia, and thyroid stimulating hormone (tsh). * diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (copd), hiv, hepatitis b virus (hbv), hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed. * current abuse of amphetamines, cocaine, opiates, or alcohol. methadone use is not allowed, however stable buprenorphine maintenance treatment for ≥ 6 months is permitted.

Keywords: hepatitis c hcv rapid virologic response sustained virologic response direct acting antiviral combination therapy tegobuvir treatment experienced hcv rna polymerase inhibitor protease inhibitor interferon intolerant interferon ineligible gs-9190 gs-9451 gs-5885 chronic genotype 1a or 1b
6-week safety and pd study in adults with nafld

Conditions: Non-alcoholic Fatty Liver Disease

Summary: in this phase 2a, randomized, double blind, placebo controlled, 3 arm, parallel- group study, safety, tolerability, and pharmacodynamics of pf-06835919 administered once daily for 6 weeks will be assessed in adults with nonalcoholic fatty liver disease


Eligibility criteria:
inclusion criteria: * bmi at least 28 kg/m2 * type 2 diabetes and/or metabolic syndrome exclusion criteria: * liver disease * type 1 diabetes * recent heart attack or stroke * inability to have an mri scan
meditation for pain

Conditions: Chronic Pain

Summary: the general scope of the study involves meditation and its effects on pain management, narcotic use, and emotional well-being. half of the participants will receive access to a meditation app, which they will be asked to use for at least 10 minutes every day for 6 weeks, while the other participants will be in the waitlist group and will receive a subscription to the meditation app after the 6 week study period ends. all participants will be asked to complete a set of questionnaires

chronic pain affects an estimated 11.2% of the us population, costs the united states approximately $635 billion per year in medical expenses and lost productivity, and fuels the current epidemic of opioid addiction. understanding alternate approaches to chronic pain management is an imperative given new guidelines for the treatment of pain, and preliminary studies indicate that meditation programs may reduce the suffering and distress that accompanies chronic pain. however, much of the research on meditation for pain has examined the effects of scheduled group interventions, delivered in-person by instructors over the course of several weeks. far less research has looked at the delivery method that is most common and arguably most sustainable for busy adults, namely, smart phone delivered contemplative applications (apps) for well-being (caws). the proposed study will examine the use and impact of a meditation apps in the context of pain. participants will be randomized to either app or a wait-list group, and will be assessed in terms of self-reported pain, distress, narcotic use. to assess efficacy, the researchers will examine the longitudinal changes in all measures in the mindfulness app group, compared to wait-list control groups.

Eligibility criteria:
inclusion criteria: * emory healthcare patient exclusion criteria: * non-english speaking patients * children, prisoners or other vulnerable populations

Keywords: contemplative applications well-being
an observational study evaluating the safety, tolerability, and efficacy of treatment of sm04690 or placebo previously injected in the target knee joint of subjects with moderately to severely symptomatic osteoarthritis

Conditions: Osteoarthritis

Summary: this long-term extension study is designed to monitor the long-term safety, tolerability, and efficacy of treatment of sm04690 or placebo previously injected in the target knee joints of subjects with moderately to severely symptomatic osteoarthritis (oa) from a samumed-sponsored sm04690-oa phase 2 or phase 3 study. no additional sm04690 or placebo therapy will be administered in this study.


Eligibility criteria:
inclusion criteria: * completion of scheduled end-of-study visit of samumed-sponsored sm04690-oa phase 2 or phase 3 studies * full understanding of the requirements of the study and willingness to comply with all study visits and assessments * subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed exclusion criteria: * unable to undergo the radiograph procedures detailed within the protocol * partial or complete joint replacement in the target knee * subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site * subjects employed by samumed, llc, or any of its affiliates or development partners (that is, an employee, temporary contract worker, or designee) responsible for the conduct of the study

Keywords: knee osteoarthritis intra-articular injection sm04690
pure red cell aplasia in patients with chronic kidney disease and in use of epoetin alfa

Conditions: Red-Cell Aplasia, Pure; Renal Insufficiency, Chronic

Summary: the purpose of this study is to determine occurrence of pure red cell aplasia in a group of participants with chronic renal insufficiency and with resistance criteria to epoetin alfa treatment.the investigational product is producted by bio-manguinhos / fiocruz (bio-epo) and it is provided by the unified health system.


Eligibility criteria:
inclusion criteria: * use of alfa epoetin manufactured by bio-manguinhos for at least 8 weeks before the moment of hyporesponsiveness diagnosis; * nonuse of alfa epoetin from another manufacturer for at least 24 weeks before hyporesponsiveness diagnosis; * presence of the criteria for pure red cell aplasia disease, which is absence of a significant reduction in serum levels of leukocytes and platelets. exclusion criteria: the screened patients who have at least one of the following criteria will be excluded from the study, and it may be replaced by another participant for the research. * if there is no legal representative, an intellectual disability that restrain the compliance and signature of informed consent, * no agreement assigning the informed consent; * it will be excluded from the study if from the moment of hyporesponsiveness diagnosis the participant have: lactation pregnancy, hypersensitivity or intolerance previously known for alfa epoetin or one of its components, intolerance or allergy to parenteral iron, acute hemorrhage, kidney transplantation, hemolysis defined as the presence of anemia associated with high levels of indirect bilirubin and lactate dehydrogenase , percentage of reticulocytes\> 1.5% absolute reticulocyte\> 75,000 / microliter. * deficiency of folate and / or vitamin b12. * pancytopenia. * in use with medications known to cause anemia and / or pure red cell aplasia as: valproic acid; azathioprine; chloramphenicol; phenytoin; isoniazid; mycophenolate mofetil. * presence of the following comorbidities: diabetes mellitus; epilepsy; chronic viral hepatitis; secondary hyperparathyroidism uncontrolled; hypertension systolic; inflammation (acute or chronic); myelofibrosis; myelodysplasia; neoplasm and thalassemias; * severe disease in the 24 weeks before the hyporesponsiveness diagnosis; including: stroke, septic shock, thromboembolic events; acute myocardial infarction * lack of information or damage to quality data that avoid disease classification as a case of hyporesponsiveness. * immunoglobulin m and immunoglobulin m serology for parvovirus b19, epstein-barr and cytomegalovirus. * serology for hiv in the last 12 months. * established immunological disease. * dosage of protein c-reactive titrated . * presence of antinuclear antibody and rheumatoid factor.
effects of immersive virtual reality on physical function, fall-related outcomes, fatigue, and quality of life in older adults

Conditions: Geriatric; Virtual Reality

Summary: to investigate the effectiveness of an immersive virtual reality intervention on physical fitness, balance, physical activity level, risk of falling, fear of falling, fatigue, and quality of life in older adults compared to an active control group (acg).

this study aims to investigate the effects of virtual reality intervention on interrelated physical and psychosocial multidimensional parameters such as physical fitness, balance, fall risk, fear of falling, fatigue, and quality of life in older adults.

Eligibility criteria:
inclusion criteria: * individuals over 65 years of age * individuals with a mini mental test score of 24 and above * individuals who can walk independently and do not use assistive devices * individuals who voluntarily agreed to participate in the study exclusion criteria: * individuals diagnosed with neurological diseases (stroke, parkinson's, multiple sclerosis) * individuals with a diagnosis of cardiovascular disease (heart failure, endocarditis, myocarditis, cardiac arrhythmias) diagnosed with psychiatric or cognitive disorders * undergone surgical operation in the last 6 months * visual impairment that makes it impossible for them to see virtual reality images * individuals diagnosed with vertigo, epilepsy * individuals diagnosed with cancer
contrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: intra-individual comparison of diagnostic performance of ceus with perfluorobutane and sulfur hexafluoride for hcc in high-risk individuals, and their role in the diagnostic algorithm of hcc.

the investigators would compare the diagnostic performance for hcc at high-risk individuals between both usg contrast agents.

Eligibility criteria:
inclusion criteria: * high-risk for hcc (liver cirrhosis, chronic hepatitis b) * treatment-naive hepatic nodule (\>= 1cm) on preceding ct, mr or ultrasound exclusion criteria: * severe cardiopulmonary dysfunction * pregnancy * refusal to enroll study

Keywords: hcc contrast-enhanced ultrasound perfluorobutane sulfur hexafluoride
mbt in groups for adolescents with bpd or subthreshold bpd versus tau - the m-gab randomized controlled trial

Conditions: Borderline Personality Disorder

Summary: background: although it is now possible to diagnose borderline personality disorder (bpd) in adolescents younger than 18 years according to the diagnostic and statistical manual of mental disorders, 5th edition (dsm-v), and studies indicates that bpd can be reliably diagnosed in adolescence, only a few evidence based treatment programmes for adolescent bpd exists. mentalization-based treatment (mbt), including group psychotherapy, has repeatedly shown to be effective in treating adult bpd, but in the case of adolescents, only individual mbt have been tested and found to be effective. aims/hypotheses: we will test whether group based mbt (mbt-g), including an introductory programme for patients (mbt-i) and their parents (mbt-p) is more effective than treatment as usual (tau) in treating adolescents with bpd or subthreshold bpd. methods/design: 112 patients referred to child and adolescent psychiatric clinics in region zealand will be randomized to either mbt or tau. inclusion criteria: meeting dsm-v bpd-criteria at the threshold (five criteria) or sub threshold level (4 criteria). follow-up will be at three and 12 months. discussion: early intervention is especially important in relation to personality psychopathology and has long-term benefits for patients, their families and society. in addition to being cost effective, using the group modality in the treatment of bpd may have several advantages. this is the first randomized controlled trial (rct) to test the effectiveness of mbt in groups for adolescents.


Eligibility criteria:
inclusion criteria: * meet a minimum of 4 dsm-5 bpd criteria * have parent's or parent substitute's commitment and ability to participate in the mbt-parents program. * score 67\< bpfs-c exclusion criteria: * comorbid diagnosis of pervasive developmental disorder, learning disability (75 \< iq), anorexia, current psychosis, diagnosis of schizophrenia or schizotypal personality disorder, antisocial personality disorder as well as any other axis-i or axis-ii psychopathology considered to be the primary diagnosis. * current psychiatric inpatient treatment * current (past two months) substance dependence (but not substance misuse) * participation in concurrent psychotherapeutic treatment outside the mbt program * not able to speak danish * lack of informed consent

Keywords: mentalization-based treatment adolescence borderline personality disorder
mhna-001 for young adults with ibs

Conditions: Irritable Bowel Syndrome

Summary: the main objective of this prospective, open-label, non-significant risk study is to assess the efficacy and safety of mahana™ ibs together with care as usual in approximately 100 young adults with irritable bowel syndrome.

following informed consent, all participants will complete a series of screening questionnaires to determine eligibility for study entry. eligible participants will be enrolled, and will receive access to mhna-001 (mahana™ for ibs). participants will use mhna-001 for 12 weeks.

Eligibility criteria:
inclusion criteria: * participant meets ibs diagnostic criteria via rome iv questionnaire. * participant has ibs, based on ibs-sss score of ≥125 at time of screening (corresponding to mild, moderate, or severe ibs). * participant is 18-21 years of age at the time of consent. * participant is able to speak, read, and understand english. * participant is capable and willing to complete questionnaires, track symptoms, and complete exercises associated with use of mahana™ ibs. * participant has unrestricted access to an ios (running ios 13 or later) or android smartphone with internet connectivity and sufficient space for mahana™ ibs to be installed. * if participant is taking any prescription ibs-related concomitant medications, he/she must have been on a stable dose/regimen for at least 30 days prior to the date of screening/enrollment and is not intended to make changes to dose or regimen during the treatment period (i.e., through week 12 of the study). exclusion criteria: * participant has a medical or psychiatric comorbidity that might account for gi symptoms, confound the measurement of ibs symptoms, or compromise the participant's ability to complete the study (ex. inflammatory bowel disease, chronic liver disease, substance abuse disorder, etc.) in the opinion of the investigator. * participant is currently using opioids or plans to use for chronic pain management and/or recreation. * participant has been hospitalized for psychiatric reasons within 12 months prior to screening. * participant is currently experiencing high depression symptom severity as indicated by a score \>14 on the phq-8. * participant is currently experiencing suicidal ideation as indicated by a score of 2 or 3 on item 9 of the beck depression index (bdi). \* * participant is currently using any prescription digital therapeutic that delivers components of cognitive-behavioral therapies. * participant has undergone cbt, any other skills-based, or gi-specific psychological therapy (e.g. dialectical behavioral therapy, acceptance and commitment therapy, behavioral activation, problem-solving therapy, gut-directed hypnotherapy, etc.) within 2 years of study entry. * participant has participated in any investigational trial within 30 days prior to screening or plans to participate in another clinical trial during the study period. * participant is currently pregnant or nursing.