Kornimate/medical-research-clean huggingface dataset:
clinical trial of fat grafts supplemented with adipose-derived regenerative cells

Conditions: Craniofacial Microsomia

Summary: although first reports of the clinical use of adipose-derived regenerative cells (adrc) suggest that this approach may be feasible and effective for soft tissue augmentation, there is a lack of randomized, controlled clinical trials in the literature. hence, this study aimed to investigate whether a novel protocol for isolation of adrc and their use in combination with fat tissue improve the long-term retention of the grafts in patients with craniofacial microsomia.

to overcome problems associated with fat grafting, such as unpredictable clinical results and a low rate of graft survival, many innovative efforts and refinements of surgical techniques have been reported. for example, condensation of living tissue and removal of unnecessary components have been performed by centrifugation, filtration or gravity sedimentation; external mechanical force has been used to expand the recipient tissue as well as the overlying skin envelope; and a recent experimental study has suggested that repeated local injections of erythropoietin might enhance retention of grafted fat. based on the finding that aspirated fat tissue contains a much smaller number of adipose-derived regenerative cells (adrc) compared with intact tissue and that these cells play pivotal roles in the adipose tissue remodeling after lipoinjection, the supplementation of fat grafts with stromal vascular fraction isolated from adipose portion of liposuction aspirates has been proposed as a method to compensate its relative deficiency of adrc. in the literature, there are at least three experimental studies demonstrating that supplementation of adipose progenitor cells enhances the volume or weight of surviving adipose tissue, and first reports of the clinical use of adrc suggest that this approach may be feasible and effective for soft tissue augmentation. however, since these studies represent level of evidence iv, which correspond to the publication of case series, there is a lack of randomized, controlled clinical trials comparing this method to current standard techniques. hence, this study aimed to fill this gap by investigating whether a novel protocol for isolation of adrc and their use in combination with fat tissue improve the long-term retention of the grafts in patients with craniofacial microsomia.

Eligibility criteria:
inclusion criteria: * unilateral craniofacial microsomia * 10 to 35 years old * phenotype (m0, m1 or m2) and (s1 or s2) according to the omens-plus classification exclusion criteria: * previous soft tissue surgery * absence of fat donor site

Keywords: adipose-derived regenerative cells cell therapy autologous fat transfer tissue engineering craniofacial microsomia
circulating biomarker for amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Summary: amyotrophic lateral sclerosis (als) is a rare disease with a worldwide incidence of 2-3 cases per 100,000 individuals/year and it is characterized by progressive neurodegeneration of motor neurons. when motor neurons degenerate the ability of the brain to initiate and control muscle movement is lost. als manifests in two forms: familiar als (fals) with inherited risk genotypes, accounts for only 10% of cases and sporadic als (sals) without apparent heritability accounts for 90% of cases. als can occur in both female and male subjects at any age but is more common in people aged over 40. although the molecular mechanism underlying the pathogenesis of als is still under investigation, recent research has revealed that diseases affecting motor neurons may be associated to alterations of rna metabolism and biogenesis of small non-coding micro rnas (mirnas). mirnas are circulating molecules, whose expression profiles are widely described to have an important potential in monitoring the progression of a disease, to promote the development of more targeted therapies and/or to determine the effectiveness of treatments. altered patterns of specific mirnas expression have been described in several pathological conditions. evidence shows a significant reduction in the levels of certain mirnas also in patients with als. among others, mirna-218 has been described to play a critical role in the onset of motor neurons differentiation and in establishing cell identity and fate. changes in the levels of mirna-218 in the serum of als patients may potentially provide useful tools to determine the possible association with this disease and to candidate it as indicator of disease progression.


Eligibility criteria:
inclusion criteria: * als patients admitted to centre for rare diseases, irccs neuromed, * patients diagnosed als within 6 months, * patients age between 20 years and 75 years old, * patients underwent to differential diagnosis using diagnostic tools (emg, ncv, mri) to exclude other diseases with similar signs and symptoms, * subjects able to communicate verbally or by using a non-verbal communication system. exclusion criteria: * pregnant women, * subjects with malignant tumor, * subjects/patients with others neurological or psychiatric disorders, * subjects/patients with systemic diseases, * subjects/patients with positive blood test for hepatitis b or c, or hiv, * patients included in other clinical trials, * subjects/patients showing inability to understand the informed consent and the study's purpose
responsiveness of endoscopic evaluation in uc

Conditions: Ulcerative Colitis

Summary: the purpose of this study of this study is to assess the responsiveness and validity of cims (central image management system)-based endoscopic evaluation of uc (ulcerative colitis) clinical disease activity by measuring: the responsiveness central reader endoscopic eis \[(endoscopic indices) (mmcs (modified mayo clinic endoscopy subscore), uceis (ulcerative colitis endoscopic index of severity) mbs (modified baron score)\] to clinical change from baseline to week 6 in a prospective trial of a treatment of known efficacy in uc.

this study will evaluate the responsiveness central reader based eis for assessing clinical disease activity. endoscopic images will be obtained from recent large multicenter randomized clinical trial and assessed using utilizing cims readers using eis (mmcs, uceis, mbs) and a vas (visual analog scale). the primary efficacy endpoint of this trial was clinical and endoscopic remission at week 6, with a secondary endpoint of endoscopic and clinical remission at week 10. for the same subjects, clinical data will be obtained including a modified ucdai (ulcerative colitis disease activity index). central readers are blinded to clinical scores.

Eligibility criteria:
inclusion criteria: * active ulcerative colitis disease defined by the presence of a modified ucdai score between 4 and 10 * only patients who had an mmcs endoscopy subscale score according to a single reader * endoscopic videos recorded for cims based central reader assessment exclusion criteria: * ucdai score less than 4 and greater than 10

Keywords: disease activity central reader endoscopic indices
effectiveness of kegal exercises on urinary incontinence impact in geriatric incontinence

Conditions: Urinary Incontinence in Geriatric Population

Summary: this research study was used to determine effectiveness of kegal exercise on urinary incontinence impact in geriatric incontinence. there were two groups, one group was experimental which was subjected to kegel exercises while other was control group without any treatment.


Eligibility criteria:
inclusion criteria: * patient 50 years of age and above. * geriatric population * male participant exclusion criteria: * patient below 50 years of age. * patient with neurological problem. * uncooperative attitude * male patients with prostate problem \& female participants
metabolic effects of whey protein supplementation after fasting in volunteers

Conditions: Ketosis; Acute-Phase Response; Insulin Resistance

Summary: this study aims to investigate the early metabolic effects and acute phase response of an oral clear supplement containing whey protein plus carbohydrates in young healthy volunteers during fasting-induced organic response

the investigators will enroll young male healthy volunteers. in this controlled crossover clinical trial, after a 12-hour fast, subjects will be randomized to consumed either: a) 200ml of carbohydrates enriched with whey protein (cho+wp; n=30); or b) 200ml of water plus maltodextrin (cho group, n=30); or c) remained fasting (fast group; n=30). blood samples will be collected after 12h-fast and three hours after the ingestion of the supplements (or 3h fast in fast group) for blood glucose; glycated hemoglobin; serum insulin; c-reactive protein; beta-hydroxybutyrate; triglycerides; albumin; chlorine and sodium assays. after a temporal break of seven days an inversion of the groups will performed so all subjects entered in the three groups. group cho+p will drink a clear non-residual supplement (698 mosm/l) having 100% whey protein isolated from total proteins, with various vitamins (b1, b6, c, d, niacin and folic acid) with a "lemon tea" flavor (nutren fresh; nestlé, são paulo, brazil). the formula contains no lactose or lipids; is formulated with a volume of 200ml, with a caloric density of 1.28kcal/ml; protein: 10g in 200ml of the product (100% whey protein isolate); and carbohydrate: 54g in 200ml of the product (74% glucose syrup and 26% maltodextrin); group cho will received a clear supplement containing 200 ml of water combined with unflavored 25 g of 100% maltodextrin (carboch - prodiet, curitiba, brazil) at 12.5% dilution (101 mosm/kg; 95kcal/200ml). the third group (fast group; n=10) will not consume any food or supplement.

Eligibility criteria:
inclusion criteria: * male young healthy volunteers exclusion criteria: or will be excluded. * individuals with obesity (calculated body mass index above 30 kg/m2) * participants reporting consumption of alcoholic beverages * consumption of any nutritional supplement during the study period

Keywords: ketone bodies whey protein fasting
auditory sensory attenuation in obesity

Conditions: Obesity

Summary: the goal of this observational cross-sectional study is to test the sensory attenuation effect with auditory stimuli comparing women with obesity and healthy-weight women. specifically, the study aims to test whether the sensory attenuation effect (i.e., the perceived loudness of a self-generated sound is weaker than when another person produces the same sound): i) is observed in obesity ii) it can be modulated in interactive action contexts, as was previously observed in healthy participants. participants will compare the loudness of target sound with a comparison tone, which can be prompt by the participant by pressing a button on their own will (i.e., individual context) or upon the experimenter\&#39;s signal (i.e., interactive context); externally-generated sounds are produced in the opposite way.

the perceived loudness of a self-generated sound is generally weaker than when another person produces the same sound. this effect is known as sensory attenuation, and it is considered a proof of sense of agency (i.e., it relies on the anticipation of the sensory-motor effects of one\&#39;s intentional action). recently, it was suggested that this effect is enhanced in interactive action contexts in healthy individuals, meaning that sounds are produced as a consequence of cooperation between individuals. participants will compare the loudness of target sound with a comparison tone, which could be generated in 4 different conditions: i) participants press a button ii) the experimenter press the button iii) participants press the button upon the experimenter\&#39;s signal (i.e., who touch the participants\&#39; arm) iv) the experimenter presses the button upon the participants\&#39; signal (i.e., who touch the experimenter\&#39;s arm). however, it is not clear whether the same effect of cooperation can be observed also when individuals experience difficulties in social interactions and relationships. to this purpose, the study compared the sensory attenuation effect for auditory stimuli in a traditional (i.e., individual) and interactive context, comparing women with obesity and healthy-weight women. indeed, relational difficulties and social withdrawal characterized this clinical condition.

Eligibility criteria:
inclusion criteria: * bmi \&gt; 30 kg/m2 (controls) * handedness: right exclusion criteria: * history of eating disorders (controls) * major psychiatric conditions (e.g., psychosis, personality disorders) * developmental disorders (e.g., autism spectrum disorders) * neurological or brain injuries disorders * motor impairments

Keywords: obesity sensory attenuation interpersonal difficulties sense of agency
the effect of angiotensin receptor-neprilysin inhibition on cardiac fibrosis in patients with hfpef

Conditions: Heart Failure With Preserved Ejection Fraction

Summary: the effectively therapeutic approaches for heart failure with preserved ejection fraction (hfpef) remain limited. the paragon-hf trial found that angiotensin receptor-neprilysin inhibition (arni) has potential benefits for the management of hfpef. nevertheless, the role of arni in cardiac fibrosis in hfpef are still unclear. we will conduct a prospective randomized controlled trial to evaluate the effect of arni on cardiac fibrosis in patients with hfpef by cardiac magnetic resonance (cmr).

heart failure with preserved ejection fraction (hfpef) comprises approximately 50% of all heart failure. the effectively therapeutic approaches for hfpef remain limited. the paragon-hf trial found that angiotensin receptor-neprilysin inhibition (arni) has potential benefits for the management of hfpef. nevertheless, the role of arni in cardiac fibrosis in hfpef are still unclear. we will conduct a prospective randomized controlled trial to evaluate the effect of arni on cardiac fibrosis in patients with hfpef by cardiac magnetic resonance (cmr). we will randomly assign 60 patients with hfpef (nyha ii-iv) class, ejection fraction ≥ 50% and elevated level of natriuretic peptides to receive sacubitril-valsartan (target 100mg bid) or placebo (100mg bid). the primary endpoint is change in extracellular volume \[ecv\] measured by cmr. the secondary endpoints were 6-minute walking distance(6-wmd), kccq, hospitalizations for heart failure, myocardial infarction and death.

Eligibility criteria:
inclusion criteria: * signed and dated written informed consent * age ≥ 45 years at time of screening * preserved systolic left ventricular function, defined by left ventricular ejection fraction (lvef) ≥ 50% * nyha classes ii-iv * h2fpef score ≥ 6 or hfa-peff score ≥ 5 exclusion criteria: * patients with a known history of angioedema * history of hypersensitivity to arni * any prior echocardiographic measurement of lvef \<45% * significant congenital heart disease * rheumatic valvular heart disease * acute coronary syndrome, cardiac surgery, other major cardiovascular surgery * probable alternative diagnoses could account for the patient's hf symptoms * systolic blood pressure(bp) \>180 mm hg or diastolic bp \>120 mm hg at visit * diastolic bp \<90 mm hg at visit 1, or symptomatic hypotension * patients with a cardiac pacemaker therapy device * egfr \<30 ml/min/1.73 m2 * serum potassium \>5.2 mmol/l at visit 1 * pregnant or nursing women
study to evaluate the efficacy of poppi apple cider vinegar prebiotic soda to improve gut health in participants

Conditions: IBS - Irritable Bowel Syndrome

Summary: this exploratory observational trial provides the opportunity to gather information on the effect of daily consumption of poppi apple cider vinegar prebiotic soda on gut health and digestion.

individuals aged 18+ with a bmi under 30 and self-reported regular issues with ibs and/or poor digestion symptoms, including bloating, gassiness, heartburn, abdominal pain, constipation or associated symptoms (self-reported), but otherwise healthy will be chosen to participate in the study (see "4. participant definition"). participants will be advised to discontinue any other oral supplement targeting the gut, including antibiotics, during the study and at least 3 months prior to. participants will be asked to complete the baseline survey on gut and skin health before the study starts. participants will also be asked to discontinue any additional soda consumption during the study. each day in the morning, for lunch, or in the afternoon, participants will drink one 12 fl oz. can of poppi acv prebiotic soda. after 2 full weeks (day 14 of the study period) of drinking poppi daily, participants will complete the 2-week follow up survey of gut and skin health. after four weeks (day 28) of the study period, participants will complete the 4-week end-of-study follow up survey of gut and skin health. making the whole study period four weeks. the gut health surveys completed at baseline, week two and week four will be evaluated to determine the impact of poppi acv prebiotic soda on symptoms of poor gut health/digestion/ibs, including bloating, gas, heartburn, constipation and abdominal pain, as well as skin health.

Eligibility criteria:
inclusion criteria: * age: 18-45 * male or female * must be in generally good health * bmi under 35 * self-reported issues with gas, bloating, heartburn/acid reflux, abdominal pain or digestion * willing to maintain their standard dietary pattern, activity level and body weight for the duration of the study exclusion criteria: * severe chronic conditions, including oncological conditions or psychiatric disease * currently pregnant, wanting to become pregnant, or breastfeeding for the duration of the study * taking any prescription medication targeting the gut * taking any supplements targeting the gut in the past month * use of antibiotics in the past 3 months

Keywords: bloating abdominal pain gassiness heartburn
effect of lumber core stability exercises on chronic non-specific neck pain

Conditions: Neck Pain

Summary: chronic non-specific neck pain patients will be enrolled in 3 groups in this study including passive, active control and experimental groups to determine the effect of adding lumbar core stability exercises to patient's advices and cervical and scapular stabilization exercises. for the last two groups, the sessions will be applied 3 times per week for 4 weeks. all the outcomes will be measured after patient's enrollment and at the end of 4 weeks to determine the difference between groups.


Eligibility criteria:
inclusion criteria: * patients with persistent cervical pain for more than 12 weeks without specific diagnosis (chronic non-specific neck pain). * bmi less than 30 kg/m2. * pain intensity on vas should be more than 3. * patient will be able and motivated in completing the study. * psychologically \& mentally stable. exclusion criteria: * red flag's symptoms including a history of major trauma, persistent night pain, bladder or bowel dysfunction, and/or lower or upper extremity neurological deficit. * pregnant women. * recent or old fractures at spine or upper limbs. * congenital, or acquired postural deformity. * no previous neck or spinal or shoulder surgery. * no current pathologies (e.g. disc lesion, nerve root compression, canal stenosis, spinal tumor, spinal infection, systemic inflammatory diseases, ...).
safety and repeatability of bronchial challenge with grass-pollen

Conditions: Allergic Asthma

Summary: the study is meant to establish a one-step challenge with grass-pollen in patients sensitized for grass-pollen. therefore the investigators compare a multi-step challenge with grass-pollen with an one-step challenge in order to survey the repeatability and safety.

background: specific provocation with inhaled allergens is an established tool in clinical practice and research, supporting the understanding of pathophysiology of allergic asthma, and analysing the efficacy of new therapies. this study examines the repeatability of a bolus-dose inhalative allergen challenge with grass pollen. method: forty grass pollen allergics should undergo an incremental-dose grass pollen challenge to calculate their pd20-dose. this calculated dose will be applicated twice to analyse the repeatability of the bolus dose challenge. before and twenty-four hours after the provocation, exhaled nitric oxid (feno) will be determined as a marker of bronchial inflammation.

Eligibility criteria:
inclusion criteria: * age \>12 \<45 years * known sensitization for grass-pollen * informed consent exclusion criteria: * age \ 45 years * clinical asthma requiring regular inhalation * vital capacity \<80% * fev1 \< 75% * chronic disease conditions or infections * pregnancy * inhalative or systemic steroid use * substance abuse * incapability of understanding the study's purpose and performance

Keywords: pd20 fev1 grass pollen one-step
the medicines advice service evaluation

Conditions: Type 2 Diabetes; Hyperlipidemias

Summary: the purpose of this study is to find out whether talking to a pharmacist on the telephone can help to support people taking medicine for a long-term condition.

non-adherence to medication is common and although some interventions have shown promise in improving adherence, the findings are inconsistent. this randomised controlled trial aims to test the effectiveness of a pharmacy-based telephone intervention compared to usual care on medication adherence and health outcomes in patients taking medicines for a long-term condition.

Eligibility criteria:
inclusion criteria: * patients prescribed medication(s) for at least one of the following conditions: type 2 diabetes, hyperlipidemia exclusion criteria: * patients living outside of england * patients with no access to a telephone * patients under the age of 18 * patients unable to give written informed consent * patients on drugs for dementia * patients showing signs of dementia or cognitive impairment in conversation * patients with substantial hearing or sight impairment * patients whose medications are ordered by a caregiver/family member * patients with insufficient english to take part in the telephone intervention * patients living with someone already taking part in the study * patients newly prescribed a medication for the conditions listed in the inclusion criteria

Keywords: adherence