Kornimate/medical-research-clean huggingface dataset:
food supplement physiomanna® baby in pediatric patients

Conditions: Irritable Bowel Syndrome Characterized by Constipation

Summary: the primary objective is to assess the efficacy and safety of the food supplement physiomanna® baby in pediatric patients with a history of functional constipation the secondary objective of the trial is to evaluate the adherence to product's administration in the enrolled children.

this is an interventional, non-controlled, multicenter trial with a prospective design in one cohort of patients. this clinical investigation will be performed in 3 centers in romania. the tested hypothesis is that physiomanna® baby administration for 3 weeks, increases the sbm to be more than 2 times per week.

Eligibility criteria:
inclusion criteria: * male or female outpatients between the ages of 0 to 8 years; * functional constipation according to rome iii criteria (annex 2); * two or fewer sbm during the previous week; sbm is defined as bm not preceded after a 24 h administration with a laxative or enema; * to be otherwise in good health, as judged by a physical examination; * mentally competent parent or tutor to sign an informed consent exclusion criteria: * known history of organic cause for the constipation; * congenital malformations that produce constipation (hirschsprung's disease, imperforate anus, children with cerebral palsy or other neurologic abnormalities, or systemic diseases); * fecal occult blood test (fobt) positive in the 4 previous weeks; * fecal impaction at baseline, or during the trial period, as indicated by the physical examination; * known or suspected perforation or obstruction other than fecal impaction; * history of gastric retention, inflammatory bowel disease, bowel resection, or colostomy; * use of concomitant medications that cause constipation in the previous 3 months; * concomitant use of herbs and other dietary supplements, such as: stimulant laxative herbs and/or potassium depleting herbs; * concomitant use of cardiac glycosides(e.g. digoxin); * patients who, according to the investigator, should not be included in the study for any reason, including the parent's inability to follow the study procedures; * patients with known allergy to fraxinus manna, mannitole, fennel, lemon balm or chamomile; * patients with clinically significant elevations of tsh or abnormal plasma electrolytes in the 4 previous weeks; * patients who, within the past 30 days have participated in an investigational clinical study;

Keywords: childhod constipation
international t1 multicenter outcome study

Conditions: Heart Failure; Cardiomyopathies; Inflammatory Disease; Coronary Artery Disease; Chronic Kidney Diseases

Summary: mapping of magnetic relaxation within the myocardial tissue using t1 (and t2) mapping using cardiovascular magnetic resonance (cmr) are novel measures of quantifiable (scalable) myocardial tissue characterisation. evidence suggests that myocardial mapping could be useful in detection of diffuse myocardial disease, complementing late gadolinium enhancement (lge) as the tool for regional myocardial disease. a handful of studies, three single centre study of a single t1 index with outcomes and one multicentre study for all indices reported strong associations with all cause mortality and heart failure. these studies were based on a single-vendor platform and were using a single sequence. the main unknowns pertaining the successful translation of this technique and the transferability of the methodology beyond a single centre and lack of outcome evidence from broad and large populations. in this study, we will assess the diagnostic accuracy of t1 (and t2) mapping measurements in health and disease, and the prognostic relevance of t1 mapping measurements by associations with outcome. this study is builds upon/integrates the evidence of the nct02407197 study, which remains active for follow-up, but is currently no longer recruiting.


Eligibility criteria:
inclusion criteria: 1. adults (\>18 years of age) 2. able to provide informed consent 3. clinically indicated cardiac magnetic resonance imaging study exclusion criteria: contraindications for clinical cardiac magnetic resonance imaging due to mr unsafe devices or objects

Keywords: t1 mapping native t1 native t2 accuracy prognosis
impact of art therapy on brain connectivity in recent post-stroke aphasia

Conditions: Ischemic or Hemorrhagic Stroke

Summary: a stroke located in the left parieto-temporal junction is associated, in aphasic right-handed patients, with a poor prognosis for language recovery. the role of the right hemisphere in recovering post-stroke aphasia is still controversial. our hypothesis, based on recent work in imaging, is that early activation of the right hemisphere linked to the practice of the visual arts could facilitate language recovery in extended posterior left strokes that completely disrupt language areas.

the investigators will evaluate, at inclusion and at 6 weeks, the reorganization of functional and structural brain connectivity maps before and after rehabilitation of aphasia with art therapy and standard orthophonic rehabilitation versus a control group that received only standard orthophonic rehabilitation. the investigators will include all consecutive patients with recent ischemic or hemorrhagic stroke with unilateral lesion(s) of the parieto-temporal left junction present on the diffusion mri (dwi) performed in acute phase at 24-48h. all patients will undergo 2 mri with tensor diffusion sequences (structural connectivity) and fmri (functional magnetic resonance imaging) resting state sequences (functional connectivity) at inclusion and 6 weeks after rehabilitation with or without art therapy. the investigators aimed to demonstrate that early activation of the right hemisphere related to the practice of the visual arts could facilitate the recovery of language in later strokes completely disrupting the language areas of the left hemisphere.

Eligibility criteria:
inclusion criteria: * patients with recent ischemic or haemorrhagic stroke with unilateral lesion (s) of the parieto-temporal left junction present on the diffusion mri (dwi) performed in acute phase at 24-48h * post stroke delay of 15 days to 2 months * existence of moderate to severe phasic disorders on aphasia rapid test score (art, score\> 6, scale of 26 items) * patient able to read and understand french * rightful * normal and corrected vision and hearing * absence of pre-existing degenerative neurological disorder * patient having signed his consent * age ≥ 18 years exclusion criteria: * patients with contraindications to mri or claustrophobic * patients under legal protection * patients with behavioral disorders or disabling neurovisual disorders making participation in art therapy impossible * mute patients, illiterate patients * patients leaving the neurological ssr department prematurely * patients not affiliated to a social security scheme * pregnant or lactating women.

Keywords: brain connectivity aphasia art therapy rehabilitation
a study to investigate the bioequivalence test of da-1229_01(a) at fasting state

Conditions: Type2 Diabetes

Summary: a study demonstrates the bioequivalence of da-1229_01(a) at fasting state when compared with sugamet sustained-release(sr) tab 5/1000mg® in healthy adults


Eligibility criteria:
inclusion criteria: * adult patients over 19 years of age at the time of health examination * female patients who were confirmed to be not pregnant at health examination * patients without a history of mental illness in the past 5 years exclusion criteria: * patients who have taken medications which could affect the results of the clinical trial in the past 10 days of participating in the clinical trial * patients with a congestive heart failure which requires medicinal treatment * patients who have made a whole blood donation in the past 2 months or an apheresis donation in the past 2 weeks of participating in the clinical trial * female patients who are lactating
symptom tracking in long covid patients using formula c™ sublingual drops

Conditions: Long COVID; Long Covid19; Post-Acute COVID-19; Post-Acute COVID-19 Syndrome; Long Haul COVID; Long-Haul COVID-19

Summary: this is a digital symptom tracking study of formula c™, a full cannabis flower formulation, rich in cannabinoids and terpenes, that has been shown to improve symptoms in people with long covid. participants 21 and older will take formula c™ for 90 days. during that time, participants will answer weekly surveys to track symptoms and wellbeing.

long covid is a global health crisis with no current treatments. there's a growing interest within the medical community to explore the potential benefits of full hemp flower extracts in treating and alleviating long covid symptoms. full hemp flower extracts are a remarkable advancement in the field of natural wellness and healing. full hemp flower extracts harness the full spectrum of beneficial compounds present in the hemp plant, including not just cannabidiol (cbd), but a host of other cannabinoids, terpenes, and flavonoids. this process, known as 'whole plant' or 'full spectrum' extraction, produces a more potent and therapeutic product, as the various compounds work synergistically in what is referred to as the 'entourage effect'. these extracts have been associated with a broad range of potential health benefits, such as pain relief, reduction of inflammation, anxiety management, and sleep improvement. a recently published single-blind, randomized, placebo controlled trial demonstrated that long covid patients benefitted from sublingual use of formula c without any safety events. this remote, observational study of endourage targeted wellness formula c™ sublingual drops will seek to empower participants to track symptoms and wellbeing while taking formula c to determine if long covid symptoms are attenuated and time to healing is shortened.

Eligibility criteria:
inclusion criteria: 1. must be at least 21 years of age. 2. willing and able to read, understand, and sign the informed consent. 3. willing to comply with all study procedures. 4. must have device to access the internet to complete surveys online. 5. a diagnosis of long covid from a health care provider. exclusion criteria: 1. non-english speaking, as the surveys are developed in the english language. 2. known allergies to hemp seeds or hemp-derived products, medical cannabis, coconut oil. 3. pregnancy, or planning to become pregnant in the next 3 months

Keywords: hemp terpenes cannabinoids entourage effect
feasibility study of phase-contrast mri for flow in the external carotid branches arteries

Conditions: Carotid Artery, External

Summary: the phase-contrast mri offers the advantage to combine precisely vascular flow measurements data with morphological images. even if the anatomy of the external carotid artery is well known, data obtained through phase contrast mri could permit to progress in several fields of cranio-maxillofacial surgery as for example arteriovenous malformations,radionecrosis, head and neck micro-reconstructive surgery. the aim of this study is to establish and develop phase-contrast mri sequences for vascular flow characterization branches of the external carotid artery in healthy patients and in pathological cases.


Eligibility criteria:
inclusion criteria: * group 1 : healthy volunteer * group 2 : x-ray treatment antecedent (at least 50 grays and older than one year) * group 3 : antecedent of embolization of branches of external carotid artery * group 4 : antecedent of muscular free flap surgery (older than one month) * free and informed consent exclusion criteria: * group 1 : facial pathology, antecedent of facial injury, antecedent of x-ray treatment in head and neck localisation, antecedent of head and neck cancer * group 2 : antecedent of surgery for head and neck cancer or for vascular disease * group 3 : antecedent of surgery for head and neck cancer or for vascular disease ; antecedent of x-ray treatment. * group 4 : antecedent of surgery for head and neck cancer or for vascular disease ; antecedent of x-ray treatment or embolization * patient with guardianship or trusteeship * mri cons-indications * pregnancy and lactation

Keywords: external carotid artery facial artery lingual artery superior thyroid artery internal maxillary artery phase-contrast mri rate of flow superficial temporal artery
osteoporosis and fall prevention and posture correction interventions in the metropolitan area

Conditions: Osteoporosis Fracture

Summary: the investigators' previous studies in 2014 and 2015 have demonstrated that among community-dwelling older adults with high osteoporotic fracture risks. many sarcopenia indices can be improved and bone mineral density (bmd) maintained with different exercise programs. in 2016, the investigators aim to determine the effects of 2 exercise interventions on posture corrections and further improvement of sarcopenic indices

the current study enrolled subjects who already participated in the 2015 study (n=109) at the national taiwan university hospital bei-hu branch (ntuhbb). subjects will be maintained in their original integrated care group (icg, target n=50) and muscle training group (mtg, target n=50) when possible. if target sample size is not reached, clinic patients are screened for high risk of fall, osteoporosis/fracture by standardized questionnaires or frax for enrollments. new participants are randomized into the icg and mtg groups. other than assessments provided in 2015, digital photography on posture and low back pain assessments are done in 2016. all participants received a cd-rom and one hour education on osteoporosis, sarcopenia, frailty, fall prevention, nutrition, low back pain, good posture, and coping strategy and another hour of professional led exercise program with more focus on central muscle groups. icg subjects received once weekly group exercise while mtg subjects received twice weekly machine-based resistance training on major muscle groups. major outcomes were muscle mass (measured by bio-impedance analysis), grip strength, walking speed, and lower leg extension power, chinese version of oswestry disability index v 2.1 score (for low back pain), and spine curve angle (by photography) at baseline and after 12-weeks of intervention.

Eligibility criteria:
inclusion criteria: 1. older than 50 years of age 2. high risk as defined from one of the following criteria: score≥1 on one minute osteoporosis risk questionnaire; 10 year predicted fracture risk≥20% for major osteoporotic fracture or ≥3% for hip fracture from frax; fall≥2 times in pass 1 year 3. having a bone mineral density test within one year period 4. having the capability to understand the study and complete the study interventions 5. willing to participate for the intervention and study follow ups exclusion criteria: 1. people younger than 50 years of age 2. could not communicate because of hearing, visual, or cognitive problems 3. unable to stand and walk unaided (walking aids are acceptable)

Keywords: spine curve posture fracture sarcopenia exercise
open-label treatment extension study for patients who complete study rna200103-201

Conditions: Hepatitis B, Chronic

Summary: compare the long-term safety of pradefovir to adefovir dipivoxyl

* compare the long-term safety of pradefovir to adefovir dipivoxyl * monitor development of resistance * evaluate virologic and biochemical response

Eligibility criteria:
inclusion criteria: * patients who completed 48 weeks of treatment in study rna200103-201 exclusion criteria: * patients who were determined to be treatment failures in study rna200103-201 * patients who experienced a serious adverse event judged to be related to study drug in study rna200103-201 * patients with a serum creatinine greater than 2.0 mg/dl on two consecutive determinations in study rna200103-201

Keywords: hepatitis b, chronic hepatitis b virus pradefovir mesylate adefovir dipivoxyl
a modified rabbit training model for establishing an emergency front of neck airway in children

Conditions: Emergency Front of Neck Airway in Children

Summary: a "cannot intubate, cannot oxygenate" (cico) situation is rare in paediatric anaesthesia, but can always occur in children under certain emergency situations. there is a paucity of literature on specific procedures for securing an emergency invasive airway in children under the age of 6 years. a modified emergency front of neck access (efona) technique using a rabbit cadaver model was developed to teach invasive airway protection in a cico situation in children. after watching an instructional video of our efona technique (tracheotomy, initial intubation with frova catheter over which an endotracheal tube is inserted), 29 anaesthesiologists will perform two separate attempts on rabbit cadavers. the primary outcome is the success rate and the performance time overall and in subgroups of trained and untrained participants.


Eligibility criteria:
inclusion criteria: * anesthesiologists working at the department of anesthesia at university children's hospital zurich exclusion criteria: * n.a.

Keywords: cannot intubate, cannot oxygenate in children emergency front of neck airway rabbit cadaver model emergency tracheotomy
bone health in facioscapulohumeral muscular dystrophy

Conditions: Facioscapulohumeral Muscular Dystrophy

Summary: this is a cross-sectional single visit study to determine bone health in individuals with fshd.

bone health will be assessed using 1) a dexa scan to measure bone mineral density and lean body mass, and 2) blood tests of biomarkers of bone resorption and formation. these procedures will be correlated to measures of muscle strength testing and timed function tests to determine fracture risk in fshd individuals considering age, gender, muscle strength and fshd allele size.

Eligibility criteria:
inclusion criteria: * genetic diagnosis of fshd including chromosome 4 deletion and haplotype * age \> 18 years * ability to provide written informed consent for participation in the study * ability to participate in the dexa scan exclusion criteria: * unwillingness or inability to comply with the requirements of this protocol (in the opinion of the pi) including, but not limited to, the presence of any condition (physical, mental or social) that precludes the participant from comfortably and safely obtaining a dexa scan, phlebotomy, or neurological examination
speech therapy and repetitive transcranial magnetic stimulation therapy in post-stroke anomic aphasia

Conditions: Aphasia; Aphasia, Anomic; Stroke

Summary: the aim of the study is to observe the effects of speech therapy and transcranial magnetic stimulation therapy in patients who develop anomic aphasia after stroke. patients meeting the inclusion criteria will be randomly divided into groups. in the repetitive transcranial magnetic stimulation (rtms) treatment group, a total of 10 sessions, 1 session per day, will be applied to the right inferior frontal gyrus area with a frequency of 1 hz for 20 minutes. the control group patients will be given speech therapy in the same way, but no active magnetic stimulation will be given in rtms sessions (sham application). speech therapy will be given to each patient by the same physiotherapist, and the treatment will last a total of 10 days, 60 minutes a day. minimental test (mmt), ege aphasia test, aphasia quality of life scale (saqol-39) will be filled in to the patients before and after the treatment.


Eligibility criteria:
inclusion criteria: * stroke diagnosed with cranial mr examination causing unilateral hemiplegia * post-stroke patients with anomic aphasia * 40-70 years * being able to read the basic instructions * medically and neurologically stable patients exclusion criteria: * clinical condition that will constitute a contraindication to tms (metallic implant, cardiac pacemaker, pregnancy, breastfeeding, epilepsy, head trauma...) * having previously had tms treatment * presence of life-threatening disease and/or active systemic disease (chronic disease, malignancy ...) * alcohol or drug addiction * presence of neurodegenerative or psychiatric disorders * pregnancy or breastfeeding status * severe cognitive impairment * having a history of previous epilepsy * visual and auditory impairment
clinical investigation of sorbact® dressings

Conditions: Hard-to-heal Wounds; Diabetic Foot Ulcer; Venous Leg Ulcer; Pressure Ulcer; Arterial Leg Ulcer

Summary: the main purpose of this exploratory clinical investigation is to study the binding of bacteria and fungi from hard-to-heal wounds to the dacc-coated dressings.

this is a prospective, open, single-centre, exploratory clinical investigation with a primary objective of studying the binding of bacteria and fungi from hard-to-heal wounds to the surface of dacc-coated dressings. subjects suffering from hard-to-heal wounds who are due to start using a dressing from the sorbact range will be recruited at one investigation site in sweden. the subjects will be divided into three groups by dressing type and there will be 10 subjects in each group, i.e., 10 subjects will be treated with sorbact® compress, 10 subjects will be treated with sorbact® gel dressing, and 10 subjects will be treated with sorbact® ribbon gauze. the dressings will be used in accordance with their respective ifu. the clinical investigation is designed to have a treatment period of 14 days with no additional follow-up. three visits are planned for each subject, including a screening/baseline visit at the clinic and two further visits to the study clinic.

Eligibility criteria:
inclusion criteria: 1. able to read and understand the subject information and informed consent form and provide meaningful informed consent 2. due to start using one of the following dressings: sorbact® compress, sorbact® gel dressing and sorbact® ribbon gauze 3. age ≥18 years 4. presence of hard-to-heal wound for ≥6 weeks with no significant wound area reduction for the last 4 weeks confirmed by investigator/study nurse exclusion criteria: 1. participating in another clinical investigation 2. known allergy or sensitivity to any components of the allocated investigational device 3. use of systemic or topical antibiotic for the past two weeks or planning to use while participating in investigation. 4. use of antimicrobial agent (e.g., silver- or iodine-containing dressings, or gels) during the last wo weeks 5. use of a dressing from the sorbact® range during the last two weeks 6. subjects with any other condition that as judged by the investigator may make investigation procedures inappropriate
safety study of a sutureless amniotic membran transplantation to treat ocular surface disorders (expanded access)

Conditions: Corneal Ulcers; Corneal Melting

Summary: the investigators aimed at developing a technique to apply amniotic membrane to a diseased ocular surface without surgical intervention (sutureless amniotic membrane transplantation). this system needs to be concordant with laws and guidelines for the use of medical and pharmaceutical products.

a ring system (amnioclip) was developed for mounting an amniotic membrane (am) that can be applied like a large contact lens. am is mounted between the two rings with a special designed, accessory mounting device. the safety of the ring system amnioclip was tested in an interventional including 7 patients with ocular surface disorders and need for am transplantation (1, 2, 3). about similar systems was reported (3, 4).

Eligibility criteria:
inclusion criteria: * patients with ocular surface disorders and indication for amniotic membrane transplantation * willingness to provide signed informed consent form * for sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study * ability and willingness to return for all scheduled visits and assessments exclusion criteria: * an eye that, in the investigator's opinion, would not benefit from amniotic membrane transplantation

Keywords: amniotic membrane holder, aminiotic membrane transplantation