Kornimate/medical-research-clean huggingface dataset:
subjects' satisfaction on pan facial aesthetic enhancement after treatment with azzalure® and the restylane® range

Conditions: Aging

Summary: the aim of this study is to assess subjects' satisfaction linked to the pan facial management of rejuvenation with injections of azzalure® and restylane® fillers. this will be an open, multi-centre study.


Eligibility criteria:
main inclusion criteria: * male or female subjects, aged 18 to 64 years, seeking treatment for correction of dynamic wrinkles of the upper third of the face and correction of facial volume loss, and meeting other specific eligibility criteria main exclusion criteria: * female subject who is pregnant, nursing or planning a pregnancy during the study * subject with any contraindications to the injection of hyaluronic acid (see package inserts) * subject with any contraindications to the injection of botulinum toxin (see package insert) * subject with a personal history of allergic/anaphylactic reactions including hypersensitivity to crossed-linked hyaluronic acid or botulinum toxin * concurrent treatment that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of at least one of the study treatments * subject with a history of dissatisfaction with facial aesthetic procedures involving dermal implant injections or subject with unattainable expectations * subject currently enrolled in another investigational study or who participated in such a study in the past 30 days prior to baseline visit
doubling the iron dose to prevent ida in twin pregnant women

Conditions: Hematologic Pregnancy Complications

Summary: in twin pregnancies, the maternal iron demands are magnified, estimated at 1.8 times more than in singleton pregnancies due to greater maternal red blood cell mass and plasma volume expansion as well as increased fetal and placental requirements. with a lack of randomized controlled trials assessing the adequacy of iron supplements on twin pregnancy, various recommendations are based on level 3 clinical expert opinions at most.

iron deficiency anemia (ida) is a very prevalent condition in pregnancy, affecting nearly 18% of all pregnant women during all three trimesters, with as many as 29%of women affected during the third trimester. in twin pregnancies, the maternal iron demands are magnified, estimated at 1.8 times more than in singleton pregnancies due to greater maternal red blood cell mass and plasma volume expansion as well as increased fetal and placental requirements. thus, maternal hemoglobin (hgb) in multiple pregnancies is lower in all trimesters compared with singleton gestations, with a rate of ida estimated to be 2.4 to even 4 times higher. expert opinion relying on the increased risk for micronutrient deficiency in twin pregnancies recommends supplementation of iron beyond that contained in a typical prenatal vitamin. moreover, some experts support doubling the dose of multivitamins containing 30 mg of elemental iron during the second and third trimesters of a twin pregnancy, regardless of maternal hgb and ferritin concentrations. with a lack of randomized controlled trials assessing the adequacy of iron supplements on twin pregnancy, various recommendations are based on level 3 clinical expert opinions at most. the purpose of our study was to assess the efficacy of a single versus a double daily iron supplement dose in iron deficient women with twin pregnancies. determining the effect of this intervention on maternal iron stores and immediate neonatal outcome measures will assist in defining evidence based recommendations for prenatal care.

Eligibility criteria:
inclusion criteria: * twin pregnancy. * hemoglobin ≥ 10.5 gm/d l. at booking visit exclusion criteria: * continuous hyper-emesis gravid arum lasting beyond 20 weeks of gestation * thalassemia minor (alpha or beta). * mal-absorption disorders (such as inflammatory bowel diseases, crohn's disease, ulcerative colitis, previous bowel resection). * anemia from chronic illness. * any use of multi-vitamin supplements containing iron. * any chronic blood loss. e.g: hemorrhoids. * autoimmune disorders.

Keywords: pregnancy, twins , iron deficiency anaemia
multicentre blinded comparison of lyophilized sterile fecal filtrate to lyophilized fecal microbiota transplant in recurrent clostridioides difficile infection

Conditions: Clostridia Difficile Colitis; Clostridium Difficile Diarrhea

Summary: fecal microbiota transplantation (fmt) is a treatment that restores the balance of gut bacteria and is the most effective treatment for patients who suffer from recurrent clostridioides difficile infection (cdi) brought on by antibiotic use. although highly effective, we do not understand how fmt actually works. freeze-dried or lyophilized fecal microbiota transplant (lfmt) has been shown to be effective. recently, filtered fecal slurry, free of any live bacteria, has also been shown to cure 5 such patients. the advantage of the filtered fecal slurry is that it may be safer to patients as it does not contain any live bacteria. we have conducted a pilot study comparing lfmt to lyophilized sterile fecal filtrate (lsff) in 9 patients, and found that the success rate of treatment was 80% vs 75% in these 2 groups. therefore we need to perform a larger multicenter study to compare lfmt to lsff to determine the success rate of curing these patients.

this prospective double blind randomized study will enroll 248 patients with recurrent clostridium difficile infection (rcdi) in a 1:1 ratio to receive either lfmt or lsff by capsules. patients will receive 15 capsules at week 0 and be assessed at weeks 1, 4, 8 and 24. blood, stool and urine samples will be collected. if the first treatment fails, patients will be given open label lfmt from the same donor. if treatment fails again, fmt will be offered in the form and route at the treating physician's discretion.

Eligibility criteria:
inclusion criteria: * at least 3 episodes of recurrent cdi with each episode defined as 3 or more unformed stools in 24 hours associated with positive clostridium difficile test, each occurring within 3 months of each other. * cdi infection under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment * ability to provide informed consent * females and males must agree to effective contraception for the duration of the study exclusion criteria: * severe or fulminant colitis * chronic diarrheal illnesses such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission 3 months prior to enrollment. * those taking or planning to take an investigational drug within 3 months of enrollment * chemotherapy or radiation therapy * oropharyngeal or significant esophageal dysphagia * ileus or small bowel obstruction * pregnant or planning to become pregnant within 3 months * breastfeeding or planning to breastfeed during the trial * active infection requiring antibiotics * life expectancy \<6 months those with history of total colectomy
food reward in cachexia induced by acute or chronic disease

Conditions: Cachexia; Chronic Obstructive Pulmonary Disease; Non-small Cell Lung Cancer; Pancreatic Cancer

Summary: to study activity in the reward-circuitry of the brain in patients suffering from cachexia induced by cancer or chronic disease.

the activity in the food reward-circuitry of the brain in patients suffering from cachexia induced by cancer (lung cancer or pancreatic cancer) or chronic disease (chronic obstructive pulmonary disease) will be analysed by using functional magnetic resonance imaging. in addition, the role of the peripheral satiety hormones will be evaluated.

Eligibility criteria:
inclusion criteria: * for cachectic patients: weight loss exceeds 5% of total body weight over the past 6 months, or \>2% when body mass index is \<20 kg/m2 * for non-cachectic patients: no weight loss of ≥5% during the last 6 months * non-small cell lung cancer or gastro-intestinal cancer, pathology proven or diagnosis of copd consistent with the global initiative for chronic obstructive lung disease (gold) criteria exclusion criteria: * contra-indications for fmri examination (operation to your head or brain in the past; implanted electronic devices, for instance a pacemaker, neurostimulator, cochlear or hearing implant; insulin pump under your skin; pregnant subjects, claustrophobia; pregnancy; metal parts in your body (except from teeth filling and connectors): implants; brain vessel clamps, prostheses, intra-uterine device, metal splinter in the eye, metal braces or other metal objects, permanent eye make-up) * psychiatric or other disorders likely to impact on informed consent * presence of brain metastasis (screening is not mandatory) * medical history of cerebrovascular accident, brain tumour, brain metastasis * previous radiotherapy to brain, both stereotactic and whole brain radiotherapy * memory problems * current use of tube feeding or parental nutrition * patients with an active second malignancy * patients unable to lie still for 2 hours * unable to complete the cognitive task * pre-existing swallowing difficulties * allergy to gluten-, milk- or wheat products * self-reported hyperthyroidism * self-reported diabetes mellitus * current use of appetite stimulant medications

Keywords: cachexia food reward
safety and tolerability of rivastigmine with add-on memantine in patients with probable alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this is a prospective, 26-week, open-label, single-arm multi-center pilot study. eligible patients will receive open-label treatment with rivastigmine capsules plus memantine tablets as add on therapy. this study is designed to evaluate the safety and tolerability of add on therapy with memantine to rivastigmine capsules in patients with probable ad (mmse 10-20)


Eligibility criteria:
inclusion criteria: * have a diagnosis of probable alzheimer's disease; * have an mmse score between 10 and 20; * must be able to swallow capsule/tablet; * must have a caregiver who is able to attend all study visits; exclusion criteria: * have an advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk; * have a current diagnosis of active, uncontrolled seizure disorder; * have a history within the past year or current diagnosis of cerebrovascular disease * have a current diagnosis of severe or unstable cardiovascular disease; * had a myocardial infarction (mi) within the last six months; * have specific respiratory, digestive, renal, or endocrine disorders; * have had previous treatment with rivastigmine or memantine; other protocol-defined inclusion/exclusion criteria may apply

Keywords: dementia, alzheimer's, rivastigmine, memantine
the recovery in stroke using pap study

Conditions: Ischemic Stroke; Obstructive Sleep Apnea

Summary: the proposed study is a randomized controlled trial among an anicipated 180 participants with acute ischemic stroke and mod/severe osa diagnosed by ambulatory polysomnography (psg) comparing pap treatment with usual care concerning the primary outcome of functional recovery.

this study has 4 aims: 3 main aims and an additional exploratory aim. specific aim 1: test whether pap treatment for osa in ischemic stroke improves stroke severity, post-stroke symptoms, post-stroke functional recovery (primary outcome), and quality of life. specific aim 2: determine whether acute vs. subacute initiation of pap in ischemic stroke results in greater improvement in post-stroke outcomes (stroke severity, symptoms, stroke recovery, quality of life). specific aim 3: conduct in-depth qualitative interviews with 25-30 stroke patients, family members, and acute care providers to elicit their experience with pap use, including factors that influence adherence. exploratory aim: evaluate whether polysomnographic measures have prognostic utility in understanding the variability in stroke recovery.

Eligibility criteria:
inclusion criteria: * having an acute ischemic stroke with brain imaging within 48 hours of symptoms onset; * being within 5 days of neurologic symptoms onset; * moderate (15 =\ = 30) osa, thus with an obstructive apnea-hypopnea index ahi \>= 15. exclusion criteria: * past use of prescribed pap for osa; * suspected sleep disorder other than osa (e.g., narcolepsy) (because such patients should be referred for a formal psg in a sleep laboratory); * life expectancy is less than 6 months (e.g., hospice patients); * patients who require mechanical ventilation (because such patients could not participate in the intervention protocol); * non-english language patients (because the intervention strategy involves forming a relationship between the patient and research staff); * central sleep apnea with \> 50% of respiratory events classified as central apnea; * resting oxygen saturation \< 90%. * inability to provide their own informed consent. to enhance the generalizability of our study, all stroke severity will be included. however, we will exclude patients who cannot provide their own consent. this is because patients will need to participate actively in the protocol with a behavioral intervention. an assessment of the patient's competence to provide consent will be made based on published recommendations.
the impact of the implementation of bis on the incidence of postoperative delirium

Conditions: Postoperative Delirium

Summary: this study will investigate the incidence of postoperative pod in patients undergoing non cardiac surgery under general anesthesia with and without the implementation of the bis monitoring.t

this study will compare the incidence of pod after elective non cardiac surgery conducted under general anesthesia before and after the implementation of bis monitoring in our university hospital. the pod will be evaluated with the cam and nu-desc tools, which have been adapted for the greek population.

Eligibility criteria:
inclusion criteria: 1. adult patients over 60 years of age 2. an american society of anesthesiologists (asa) physical status i to iii 3. undergoing elective non cardiac surgery under general anaesthesia 4. native speakers of the greek language 5. eligible to leave the post-anaesthesia care unit 6. an expected in-hospital stay at least 24 hours following surgery exclusion criteria: 1. refused to participate or sign the informed consent form 2. surgery or anaesthesia within the last 30 day 3. any prior or current history involving an affliction of the central nervous system 4. severe hearing or visual impairment 5. psychiatric disorders 6. a score less than 5 according the geriatric depression scale (gds-15) 7. a score less than 4 for females and less than 2 for males according to the lawton-brody instrumental activities of daily living scale (i.a.d.l.) 8. alcohol consumption less than 35 units/week 9. drug dependence 10. previous neuropsychological testing 11. haemodynamical instability 12. peri-procedural desaturation (one or more events of spo2\<80% for more than 2 minutes)
ginkgo biloba prevention trial in older individuals

Conditions: Dementia; Alzheimer's Disease

Summary: this study will determine the effect of 240mg/day ginkgo biloba in decreasing the incidence of dementia and specifically alzheimer's disease (ad), slowing cognitive decline and functional disability, reducing incidence of cardiovascular disease, and decreasing total mortality.

participants will be studied in a randomized trial of 240 mg of ginkgo biloba as compared to placebo in healthy men and women, at least 75 years old. the trial will last approximately 8 years. the intervention will be considered unsuccessful in those participants who succumb to dementia, including alzheimer's disease and vascular dementia. there are four clinical centers: pittsburgh, pa; hagerstown, md; winston-salem, nc; and sacramento, ca; and a coordinating center at the university of washington, seattle. there will be a clinic visit every 6 months to determine morbidity, mortality and change in cognition that will include repeat of adas, cdr, and 10 battery neuropsychological evaluation and informant interview. the primary endpoint is dementia, specifically alzheimer's disease, secondary endpoint will include the incidence of vascular disease, changes in cognitive function scores over time, total mortality and changes in functional status. the diagnosis of dementia will be based on neuropsychological testing, neurological exam, mri, functional measurements, and review by a central adjudication committee and classified by dsm iv, nincds criteria and adrtc criteria for vascular disease.

Eligibility criteria:
inclusion criteria: * non-demented participants * willing to participate in a seven-year follow-up trial of ginkgo biloba * english is their usual language * willing informant who has frequent contact with the participant exclusion criteria: * currently on anticoagulant therapy * cancer diagnosed and treated within the past two years (except for skin cancer) * participant with class iii - iv congestive heart failure * currently being treated with psychopharmacological drugs for depression * hospitalized for depression within the last year * taking aricept (or similar agents) for cognitive problems or dementia * baseline blood creatinine \>2 * baseline sggt is a marker of liver function (3 x normal\>or=90 iu) * baseline hematocrit\<30 * baseline white blood count\>or=15,000
ultrasound-guided dual tap block: magnetic resonance (mr) evaluation of the distribution of local anesthetic

Conditions: Pain, Postoperative

Summary: using magnetic resonance (mr) scanning and ultrasonography the investigators wish to investigate, in what way a known volume of local anesthetic injectate will be distributed in the transverse abdominis plane (tap) in young healthy male volunteers. the investigators compare the anatomical distribution of the local anesthetic injectate in the tap when performing an ultrasound-guided classical tap block and a dual tap block. the investigators also want to compare the spread of anesthetized frontal dermatomes when performing an ultrasound-guided classical tap block and a dual tap block.

there has been much debate as to what extent the classical tap block will anesthetize more than the frontal dermatomes (th10-th12/l1). some cadaver studies have been performed with injection of dye in the classical tap. however, it is still not clear whether a single injection of local anesthetic in the classical tap block position will reach the more cephalad and medial intercostal tap plexus (th6-th9). in this study the investigators use mr scanning and ultrasonography to investigate in what way a known volume of local anesthetic injectate will be distributed in the transverse abdominis plane (tap) in young healthy male volunteers. the investigators compare the anatomical distribution of the local anesthetic injectate in the tap when performing an ultrasound-guided classical tap block and a dual tap block. the investigators also want to compare the spread of anesthetized frontal dermatomes when performing an ultrasound-guided classical tap block and a dual tap block.

Eligibility criteria:
inclusion criteria: * healthy male * 18 years old or more * had no previous abdominal surgery * no regular medication * no coagulation disorders * no claustrophobia exclusion criteria: * if the volunteer is not able to accept an uncomplicated administration of a classical (single) or dual tap block
correlation between radiculopathy and quality of life in patients with chronic lumbar spondylosis

Conditions: Lumbar Spondylosis

Summary: this study will be conducted to answer the following question: is there a correlation between lumbar radiculopathy and quality of life in patients with chronic lumbar spondylosis?

spondylosis is an age-related change of vertebrae and discs of the spine. these changes are often called degenerative disc disease and osteoarthritis. when this condition is in the lower back, it's called lumbar spondylosis. lumbar osteoarthritis, disc degeneration, degenerative disc disease, and spondylosis are some of the terms used to describe disc changes. in fact, the condition is called spondylosis. whenever there is a degeneration co-occurrence in the disc, the lumbar spine, the formation of osteophytes and the associated changes in the nerves and the resulting symptoms of pain.spinal osteoarthritis (oa) is a degenerative process defined radiologically by joint space narrowing, osteophytosis, subchondral sclerosis, and cyst formation. osteophytes included within this definition fall into one of the two primary clinical categories. the first, spondylosis deforms describes bony outgrowths arising primarily along the anterior and lateral perimeters of the vertebral endplate apophyses. these hypertrophic changes are believed to develop at sites of stress to the annular ligament and most commonly occur at thoracic t9-10 and lumbar l3 levels.these conditions lead to nerve root compression, resulting in radiating pain down the leg, commonly referred to as sciatica. the impact of lumbar radiculopathy extends beyond pain, affecting muscle function and neuromuscular control. the involvement of nerve roots such as l4, l5, and s1 can particularly affect the muscles in the lower extremities, including the plantar flexor muscles, which are crucial for movements like walking, running, and maintaining balance

Eligibility criteria:
inclusion criteria: * all patient diagnosed and referred from a physician * patients suffered from lumbar spondylosis (l4: l5) with radiculopathy more than 3 months * participants will be from both gender * age will be ranged from 30 to 50. * bmi of all participants ≤ 30 kg/m2 exclusion criteria: * pregnant and breast-feeding women * patients diagnosed with depression and anxiety * patient who had undergone lumbar spine surgery * people with systemic illnesses or physical deformities

Keywords: quality of life radiculopathy lumbar spondylosis
effects of clinical interventions for the management of late start

Conditions: Athletes

Summary: introduction: late-onset muscle pain (doms) is characterized by a type of temporary muscle damage, common after high-intensity exercise. in addition to pain, doms clinically generates muscle stiffness, reduced joint range of motion, muscle weakness and reduced peak torque. in this regard, in order to accelerate the recovery of body systems and treat symptoms of doms, the management of different types of interventions has been observed, supporting the clinical practice, based on evidence. objectives: to investigate the effect of different types of clinical interventions for the treatment of doms. material and methods: for the clinical trial, 50 ultramarathon and rowing athletes of both sexes, aged between 18 and 60 years old, will be recruited randomly into four possible groups: control (cg), shock waves (g1) , massage (g2) and laser therapy (g3). the evaluation moments will be as follows: minutes before exercise (m1); immediately after exercise (m2); immediately after applying the recovery technique (m3); and 24 hours after exercise (m4) and the evaluated outcomes will be: pain, psychological aspects, functional test and blood markers.


Eligibility criteria:
inclusion criteria: * professional athletes; * age over 18 years; * both sexes; * not having recent injuries exclusion criteria: * participants who do not complete all the proposed collection moments * who do not agree to participate will be excluded.

Keywords: lasertherapy shockwaves massage sports medicine athletic performance