Kornimate/medical-research-clean huggingface dataset:
healthy vs unhealthy obesity: mehanistic insights and effects of time-restricted eating

Conditions: Metabolically Healthy Obesity; Intermittent Fasting

Summary: obesity-related cardiometabolic diseases are now a leading cause of death worldwide. these diseases result from a dysfunctional adipose tissue (at) that induces inflammation, insulin resistance and altered endocrine function. however, not all obese people develop metabolic complications, which has given rise to the concept of "metabolically healthy obesity" (mho). recent evidence suggests that intermittent fasting methods, in particular time-restricted eating (tre) may be effective in improving cardiometabolic health, independently of weight loss, and this could be particularly effective in muo subjects. the investigators hypothesize that in young male adults tre is a more effective/beneficial approach in muo than in mho due to the weight loss-independent improvement in their inflammatory and metabolic derangements. to this aim, a 16-week 8h tre intervention study will be performed in mho and muo subjects, assessing anthropometric, endocrine, and other outcomes.

although clinical differences between metabolically healthy and unhealthy obesity (mho and muo, respectively) have been extensively described, cellular mechanisms involved in these different phenotypes are largely unknown. this evidence is crucial for proposing preventive and therapeutic approaches. recently, intermittent fasting methods, in particular time-restricted eating (tre, a self-selected daily limited eating window protocol), have shown to be effective in improving cardiometabolic health, independently of weight loss, which could be particularly relevant in muo. the investigators will recruit young (20-22y-old) males with obesity (body mass index≥30) and classify them as mho or muo (≤1 or ≥3 metabolic syndrome risk factors, respectively). a 16-week, 8h tre intervention will be conducted in mho vs. muo subgroups, to assess and compare the anthropometric, metabolic, endocrine, inflammatory and peripheral blood mononuclear cell (pbmc) mechanistic/signaling response. the investigators expect to advance the understanding of cellular mechanisms implicated in mho and muo, including potential therapeutic targets. ultimately, the investigators expect to find relevant opportunities for intervention to prevent the serious cardiometabolic consequences of obesity.

Eligibility criteria:
inclusion criteria: * belong to the gocs cohort at inta * bmi≥30 * own and use a smartphone with apple ios or android os * baseline eating period ≥ 13 h per day. exclusion criteria: * medications for any metabolic syndrome disorder * shift workers * known inflammatory and/or rheumatologic disease * history of cardiovascular event * thyroid or adrenal disease, malignancy or diabetes * history of eating disorder. * special diet (e.g., celiac disease),or any other disease or treatment that may interfere with the study.

Keywords: time restricted eating metabolic health pbmc adipokines
apraxia of speech: comparison of epg treatment (tx) and sound production treatment (spt)

Conditions: Apraxia of Speech; Aphasia, Acquired; Speech Disorders

Summary: the purpose of the proposed research is to examine the effects of two treatment approaches on speech production involving speakers with chronic apraxia of speech (aos) and aphasia. the planned investigation is designed to examine the acquisition, maintenance and generalization effects of each treatment. one approach, electropalatography (epg) uses visual biofeedback in conjunction with articulatory-kinematic treatment and the other approach, sound production treatment (spt) is one of the most systematically studied articulatory-kinematic treatments for aos.

epg has been used to treat apraxia of speech (aos) as well as other speech production disorders (i.e., articulation disorders \& cleft palate). spt is one of the most systematically studied treatment approaches for aos. both treatment approaches are considered clinical treatment approaches/standards of care for aos. the pseudopalate used in conjunction with epg treatment is an acceptable device for treating speech production disorders including aos. the pseudopalate is custom-fit for each patient and is similar to a dental retainer and is considered minimally invasive. the purpose of this research is to systematically examine the effects of treatment on speech production using epg treatment vs. an spt approach. the planned investigation is intended to explicate the acquisition, maintenance, and generalization effects of each treatment approach. the specific experimental questions to be addressed are as follows: 1. will treatment using an epg approach or an spt approach result in greater accuracy of articulation of trained speech sounds produced in words? 2. will treatment using an epg approach or an spt approach result in greater accuracy of articulation of untrained exemplars of trained speech sounds produced in words (i.e., response generalization)? 3. will treatment using an epg approach or an spt approach result in greater long term maintenance effects for trained speech sounds? 4. do different treatment approaches result in distinct ratings of functional communication skills via the aphasia communication outcome measure (acom; doyle et al., 2012) and an outcome measure of speech intelligibility using the assessment of intelligibility of dysarthric speech (aids; yorkston \& beukelman, 1981)?

Eligibility criteria:
inclusion criteria: * veterans or non veterans with apraxia of speech who reside in the salt lake city region (commutable), * 6 months or more post stroke or other focal brain injury, no other neurological conditions * native english speakers, hearing adequate for experimental task (e.g., pass puretone screening at 35db at 500, 1k, 2k hz or adequate aided hearing) * non linguistic cognition within normal limits exclusion criteria: * less than 6 months post stroke * insufficient hearing, insufficient non linguistic cognitive skills * neurological conditions other than stroke * unable to attend treatment in the salt lake city vicinity

Keywords: apraxia of speech treatment
a study to evaluate the long-term effect of tev-48574 in moderate to severe ulcerative colitis or crohn's disease

Conditions: Crohn Disease; Colitis, Ulcerative

Summary: the primary objective of the study is to evaluate the efficacy of 2 different maintenance dose regimens of tev-48574 subcutaneous (sc) administered every 4 weeks (q4w) in adult participants with inflammatory bowel disease (ibd). secondary objectives of the study are to: * evaluate the efficacy of 2 different maintenance dose regimens of tev-48574 sc administered q4w in adult participants with ibd * evaluate the safety and tolerability of 2 different maintenance dose regimens of tev-48574 sc administered q4w in adult participants with ibd * evaluate the immunogenicity of 2 different maintenance dose regimens of tev-48574 sc administered q4w in adult participants with ibd the total duration for a participant in the double-blind period only is 66 weeks; and for a participant in the open-label extension (ole) period, up to an additional 268 weeks.


Eligibility criteria:
inclusion criteria: * maintenance period- participants who achieved clinical response and/or clinical remission at week 14 of tv48574-imm-20036 (the 14-week drf study) or in the re-induction period of this study. * re-induction- participants who did not achieve clinical response and/or clinical remission at week 14 of the tv48574-imm-20036 drf study note- additional criteria may apply, please contact the investigator for more information exclusion criteria: * participants who discontinued the tv48574-imm-20036 study before scheduled week 14 visit (any reason including lack of efficacy, safety, or personal reasons) * participant has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the participant at increased risk during the study as judged by the investigator and/or the clinical study physician. * participant anticipates requiring major surgery during this study. * participant is currently pregnant or lactating or is planning to become pregnant or to lactate during the study or for at least 50 days after administration of the last dose of imp in case of early termination. any woman becoming pregnant during the study will be withdrawn from the study. note- additional criteria apply, please contact the investigator for more information
venous thrombosis virtual surveillance in covid-19

Conditions: Covid19; Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism

Summary: the overall goal of the vvirtuoso study is to determine the incidence of vte including symptomatic dvt and pe after hospital discharge in patients with covid-19 by implementing a pragmatic patient-centred prospective virtual vte monitoring program in canada and the united states.

emerging evidence suggests that covid-19 induces a highly prothrombotic state particularly among hospitalized patients based on abnormal coagulation parameters and high rates of venous thromboembolism (vte). reported rates of vte among hospitalized ward (3%) and critically ill (17% to 69%) patients with covid-19 suggest that the risk of vte is substantially higher than patients with other acute medical illnesses. vte, which includes deep vein thrombosis (dvt) and pulmonary embolism (pe), is one of the most common preventable causes of hospital-associated morbidity and mortality, and most events occur after hospital discharge. the incidence of vte after hospitalization for covid-19 is not currently known. however, the combination of covid-induced hypercoagulability, ongoing recovery, reduced mobility, advanced age, and comorbidities likely confers a high risk of vte in this setting. the overall goal of the vvirtuoso study is to determine the incidence of vte including symptomatic dvt and pe after hospital discharge in patients with covid-19 by implementing a pragmatic patient-centred prospective virtual vte monitoring program at 12 sites in canada and the united states. additional objectives are to explore risk factors for vte post-discharge, characterize the use of pharmacological measures for vte prevention, assess patient awareness of vte and provide vte education.

Eligibility criteria:
inclusion criteria: i) adults 18 years of age or older (or their delegate) ii) admitted to hospital with covid-19 (laboratory confirmed) or diagnosed with covid-19 (laboratory confirmed) during hospitalization iii) discharged from acute care hospital within prior 7 days. exclusion criteria: i) unconfirmed diagnosis of covid-19, ii) no access to a telephone, computer or tablet for virtual assessment, iii) treated with therapeutic doses of anticoagulation after hospital discharge (e.g. atrial fibrillation, mechanical heart valve, previous vte), iv) patient (or their delegate) is unable or unwilling to provide informed consent,
comparison of high power pain threshold ultrasound and ischemic compression techniques for treatment of trigger points

Conditions: Trigger Point Pain, Myofascial

Summary: this study aimed to compare the efficacy of ischemic compression and two different application methods of high power pain threshold ultrasound techniques on latent trigger point treatment. asymptomatic subjects divided into three groups. first group took high power pain threshold ultrasound in which the intensity is kept constant at the pain level; second group took high power pain threshold ultrasound which the intensity is kept constant at half the pain level and third group took ischemic compression. all participants were asked to complete the questionnaires, which assessed pain, psychological factors and disability before treatment, after 1 week and 1 month follow-up. after each participants completed the questionnaire, the physical therapist evaluated the mtrps. mtrps assessment was performed before treatment, immediately after treatment, after 1 week and 1 month follow-up.

myofascial trigger points have been defined as discrete and hyperirritable areas located within a taut band of skeletal muscle or fascia which when compressed produce pain, tenderness, dysfunction and autonomic phenomena. the treatment techniques aimed to return the fiber groups affected by myofascial trigger points to their normal length and endplates to their normal function. although both ischemic compression and two different application methods of high power pain threshold ultrasound techniques are effective methods in the treatment of trigger points , there are no studies showing which technique is more effective. it is aimed to to compare the efficacy of ischemic compression and two different application methods of high power pain threshold ultrasound techniques on myofascial trigger point treatment.

Eligibility criteria:
inclusion criteria: 1. being aged between 18-50 2. the presence of a minimum of 3 latent trigger points in upper trapezius, levator scapulae, supraspinatus, infraspinatus, deltoid anterior, pectoralis major, pectoralis minor muscles 3. no health problems 4. signed the voluntary consent form exclusion criteria: 1. have a neck, spine or shoulder injury in the last 6 months 2. continued neck and back pain in the last 6 months 3. having a skin disease that may affect upper extremity assessment 4. malign and benign tumors 5. pain relief medication 6. having psychiatric treatment. -

Keywords: high power pain threshold ultrasound ischemic compression pain trigger points pain pressure threshold
voiding school as a treatment of children's day-time incontinence or enuresis

Conditions: Daytime Wetting; Enuresis; Functional Incontinence

Summary: the voiding school is a simple educational intervention to treat children with daytime incontinence or enuresis.the purpose of this study is to implement the intervention in primary care, child welfare clinics. half of the participated children will receive treatment according the voiding school protocoll and half of them will receive treatment as usual. patient outcomes are evaluated by measuring changes in wetting episodes. aim is also to evaluate the implementation process.

children under school age attend to regular visits in child welfare clinics for health examination and guidance. if the child have daytime incontinence or enuresis during the yearly visit at the age of 5 or 6, he or she is eligible for participating the study aiming to implement and evaluate the voiding school intervention. in the voiding school the children are educated in groups of 4-6 children with child-oriented methods highlighting learning by doing in order to achieve better bladder control. usual care includes individual advice concerning voiding habits and general life-style advice.

Eligibility criteria:
inclusion criteria: * the child is eligible for participating the study, if he or she has day-time incontinence or enuresis weekly, provided that following inclusion criteria are met: 1) there is no organic cause for incontinence, 2) he or she have no diagnosed behavioral disorders, and 3) the child and the parents are able to communicate in finnish. exclusion criteria: * no specified exclusion criteria were set.

Keywords: intervention implementation children urotherapy
a study to assess the efficacy and safety of risankizumab in participants with moderately to severely active crohn's disease who failed prior biologic treatment

Conditions: Crohn's Disease

Summary: the objective of study m15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active cd.


Eligibility criteria:
inclusion criteria: * male or female aged \>=18 to \<= 80 years, or minimum age of adult consent according to local regulations, at the baseline visit. where locally permissible, participants 16 to \< 18 years of age who meet the definition of tanner stage 5 for development at the baseline visit. * confirmed diagnosis of cd for at least 3 months prior to baseline. * crohn's disease activity index (cdai) score 220 - 450 at baseline. * confirmed diagnosis of moderate to severe cd as assessed by stool frequency (sf), abdominal pain (ap) score, and simple endoscopic score for crohn's disease (ses-cd). * demonstrated intolerance or inadequate response to biologic therapy for cd. * if female, participant must meet the contraception recommendations. exclusion criteria: * participant with a current diagnosis of ulcerative colitis or indeterminate colitis. * participants with unstable doses of concomitant crohn's disease therapy. * receipt of crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to baseline or ustekinumab within 12 weeks prior to baseline), or any investigational biologic or other agent or procedure within minimally 35 days or 5 half-lives prior to baseline, whichever is longer. * prior exposure to p19 inhibitors (e.g., risankizumab). * complications of crohn's disease. * having an ostomy or ileoanal pouch. * known active coronavirus disease 2019 (covid-19) infection.

Keywords: abbv-066 bi 655066
o6-benzylguanine and carmustine in treating patients with stage ia-iia cutaneous t-cell lymphoma

Conditions: Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Stage I Cutaneous T-cell Non-Hodgkin Lymphoma; Stage II Cutaneous T-cell Non-Hodgkin Lymphoma

Summary: this phase i trial is studying the side effects and best dose of carmustine given together with o(6)-benzylguanine in treating patients with stage i or stage ii cutaneous t-cell lymphoma that has not responded to previous treatment. drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. combining more than one drug may kill more cancer cells

primary objectives: i. to determine the kinetics of agt depletion in ctcl skin lesions. ii. to determine the toxicity of low dose bcnu plus o6bg. outline: this is a dose-escalation study of carmustine. patients receive o6-benzylguanine iv over 1 hour followed by topical carmustine once every 2 weeks. treatment continues in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of carmustine until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. patients are followed for 6 weeks.

Eligibility criteria:
inclusion criteria: * histologically confirmed ctcl, stages ia-iia * performance status ecog grade 0, 1, or 2 * patients must have recovered from toxicity of prior treatment and have received no ctcl therapy other than emoliation for at least 4 weeks * patients must have signed a consent form indicating the investigational nature of the treatment and its potential side effects * wbc \> 4,000/ul * anc \> 2,000/ul * platelets \> 100,000/ul * bilirubin \< 1.5 mg/dl * sgot within normal range * prothrombin time within normal range * creatinine =\ = 70 ml/min * calcium and electrolytes normal * glucose-controlled (diet and insulin) diabetes is permitted * dlco \> 80% normal with the exception of patients who demonstrate clinically normal lung function based on history, physical examination, and chest x-ray as interpreted by the principal investigator * only those patients with biopsiable tumor and willing to undergo several biopsies will be eligible * must have failed 1 conventional treatment other than topical corticosteroids; this includes uvb, puva, topical mechlorethamine, electron beam, photopheresis, chemotherapy and immuno-modulatory agents such as cytokines exclusion criteria: * patients with a prior treatment with a nitrosourea * patients with known central nervous system involvement or primary cns malignancies will be ineligible * patients with performance status ecog grade 3 or 4 * pregnant women, women who are breast feeding infants, or women with reproductive potential not practicing adequate contraception, because of potential toxicity to the fetus or infant * patients with active infection * patients with pulmonary disease as determined by history, physical examination, chest x-ray or pulse oximetry * ctcl patients with stage iib-ivb disease
tdcs in acute stroke

Conditions: Stroke

Summary: the purpose of this study is to determine the safety of transcranial direct current stimulation in aphasia therapy in acute and post-acute stroke.

tdcs has been shown to have a positive effect on clinical outcome in both motor rehabilitation and aphasia treatment in chronic aphasic patients. in healthy subjects the method sped up reaction times in naming and language learning tasks. in tdcs a weak current is applied to the subjects head increasing excitatory activity which might lead to improved brain function.

Eligibility criteria:
inclusion criteria: * first media stroke * language impairment * informed consent * right handedness * nihss \< 20 exclusion criteria: * previous epilepsy oder epileptogenic events * epilepsy typical elements in eeg * hypersensitive skin (head) * metal implants (head) * pace maker or other electronic implants * previous head/brain surgery * medication reducing seizure threshold * previous psychiatric events

Keywords: tdcs stroke aphasia naming
a study of ixekizumab in chinese participants with psoriasis vulgaris

Conditions: Psoriasis

Summary: the purpose of the study is to research how much ixekizumab enters the bloodstream and how long the body takes to get rid of the drug and the safety of ixekizumab and any side effects that might be associated with it. the study has two parts: a single-dose part and multiple-dose part. the single dose part of this study will last up to 24 weeks, including the screening period. the multiple dose part of this study will last up to 32 weeks including the screening period.


Eligibility criteria:
inclusion criteria: * males or females aged ≥18 years. * diagnosis of chronic plaque psoriasis for ≥6 months before baseline. * candidates for phototherapy and/or systemic therapy. * ≥10% body surface area (bsa) involvement at screening and baseline. * static physician's global assessment (spga) score ≥3, and psoriasis area and severity index (pasi) score ≥12 at screening and baseline. exclusion criteria: * clinically significant flare of psoriasis during the 12 weeks before baseline. * systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks. prior to baseline or topical psoriasis treatment or medicated shampoo within 2 weeks prior to baseline . * current or recent use of any biologic agent within the required washout periods. * clinical evidence or suspicion of active tuberculosis or previously had evidence of active tuberculosis and did not receive appropriate and documented treatment.