Kornimate/medical-research-clean huggingface dataset:
treatment of popliteal aneurysms with viabahn stent graft in elective surgery

Conditions: Popliteal Aneurysm

Summary: this multicentric, prospective study will evaluate the medium-term outcomes of patients implanted with gore viabahn® stent grafts for popliteal artery aneurysms in scheduled elective surgery with the registry of the research in vascular surgery university association (aurc)


Eligibility criteria:
inclusion criteria: * \> 18 years old at time of treatment * symptomatic or asymptomatic popliteal artery aneurysm needing surgery * scheduled elective surgery exclusion criteria: * life expectancy of \<1 year * thrombotic occlusion of popliteal artery * intolerance to antiplatelet drugs (antiaggregants) * known allergies to gore viabahn® stent graft materials/composition * emergency surgery
a pilot study of osi-461 in patients with chronic lymphocytic leukemia (cll)

Conditions: Chronic Lymphocytic Leukemia

Summary: the objectives of this study are to evaluate the safety and efficacy of osi-461 in cll patients.

the primary objective of this study is to determine the activity of osi-461 given twice daily orally in previously untreated cll patients. the secondary objective is to evaluate the safety profile of osi-461 in this patient population.

Eligibility criteria:
inclusion criteria: * diagnosis of cll established by bone marrow aspiration and biopsy or flow cytometry of peripheral blood. * no previous therapy for cll. * expected remaining life span greater than or equal to six months. * 18 years or older. * willingness and ability to sign an informed consent. exclusion criteria: * other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years. * history of other malignancy which could affect the diagnosis or assessment of osi-461. * previous therapy for cll. * use of an investigational medication or device within one month of initiating study therapy. * concurrent immunotherapy. * use of steroids at the time of enrollment (patients who require steroids after enrollment may remain on study). * any condition or any medication which may interfere with the conduct of the study. * serious uncontrolled intercurrent medical or psychiatric illness, including serious infection. * evidence of cns involvement. * pregnant or nursing women.

Keywords: chronic leukemia leukemia cll
evaluation of effectiveness of combining high protein intake with early physical exercise during critical illness

Conditions: Muscle Weakness

Summary: assessment of effectiveness of combined high protein intake with early physical exercise by ultrasound measurement of rectus femoris muscle thickness in intensive care unite mechanically ventilated patients.

muscle wasting and weakness is a frequent finding in critically ill patients and is associated with worse short- and long-term outcomes like delayed liberation from mechanical ventilation, longer intensive care unit and hospital stay, worse physical function and quality of life.

Eligibility criteria:
inclusion criteria: * patients in age group 18-60 years * expected intensive care unit stay \>4days after enrolment (to permit adequate exposure to the proposed intervention) * previously healthy, well-nourished, subjects (nutric score=0) exclusion criteria: * renal, liver or heart disease or chronic obstructive pulmonary disease * previous immune abnormalities (including treatment with corticosteroids) * past history of nutritional problems, chronic use of drugs (as drugs inducing myopathies) or orthopedic problems (such as skeletal fractures or immobilization) in the previous 2 years * neuromuscular diseases and patients with amputated lower limbs * past or recent history of cancer * long term critically ill patients shifted from other hospitals * pregnant patients
acute stress recovery

Conditions: Stress

Summary: the proposed study aims to evaluate whether different features of a relaxation room affect how individuals recover from acute stress. this study will use a unique methodology to capture participants' physiological and behavioral measures through a combination of non-invasive technologies, including wearables devices, active sensors, cognitive tasks, and/or subjective questionnaires. participants will perform a stress induction task, after which they will rest in a relaxation room. physiological measures and cognitive performance will be recorded throughout the experiment to determine whether features of the relaxation room promote recovery after acute stress. identifying the occurrence of stress and ways to potentially reduce the effects of stress could lead to novel interventions for helping individuals reduce work-related stress.


Eligibility criteria:
inclusion criteria: 1. adults at least age 18 2. participants are able to remain in the well living lab for 3-4 hours 3. participants are able to perform scripted tasks 4. participants are able to provide informed consent 5. participants are able to wear the wearable devices at all times during the study 6. participants have completed a covid vaccine regimen and can provide written documentation verifying vaccination status at least fourteen (14) days prior to the commencement of the research study exclusion criteria: 1. participants with a reported history of diagnosed mood, anxiety, or major health disorders 2. participants who have used steroid-based medications within the past three years 3. participants with a history of drug/alcohol abuse 4. participants with or recovering from nicotine dependency who cannot use a nicotine patch 5. participants who consume excessive amounts of caffeine 6. participants who have had severe sleep disturbance (e.g., shift work, chronic insomnia) 7. women who are pregnant or intend to become pregnant at the time of the study 8. participants with a history of diagnosed cognitive impairment 9. participants taking any medications that might affect the physiological measures of interest 10. participants with anything that might affect collecting the physiological measures of interest (e.g., cosmetic products, head coverings, head products, etc.).
a randomized, double-blind, placebo-controlled, dose response study of amg 162 (denosumab) in japanese postmenopausal osteoporotic subjects

Conditions: Osteoporosis

Summary: the primary objective of this study is to assess the effect of amg 162 (denosumab) treatment on the lumbar spine bmd at month 12 and safety profile across the dose range tested (14, 60 and 100 mg sc once every 6 months) in japanese postmenopausal osteoporotic subjects compared with those treated with placebo over 12 months.


Eligibility criteria:
inclusion criteria: - ambulatory postmenopausal women. - bmd values (g/cm2, hologic) must be lower than 0.714 at lumbar spine, 0.515 at femoral neck, 0.588 at total hip. - bmd values must not be lower than 0.535 at the lumbar spine, 0.406 at the femoral neck and 0.478 at the total hip. exclusion criteria: - oral bisphosphonate treatments, pth or pth derivatives use within the last 12 months and administration of any of anti-osteoporotic treatments within the last 3 months before initial administration of the investigational product. - history of hypocalcemia. - more than two moderate vertebral fractures or any severe vertebral fracture.

Keywords: rankl rank denosumab amg 162 osteoporosis bone turnover bone mineral density japanese
comparison levobupivacaine and ropivacaine for tap-block after caesarean section

Conditions: Pain, Postoperative

Summary: randomized, double-blind, controlled trial: a comparison of levobupivacaine and ropivacaine for postoperative analgesia using tap-block objectives: 1. vas score during the first 12 hours 2. determine which drug is more effective for postoperative analgesia in the first 12 hours after surgery 3. side effects

for tap-block was used hirokain® (levobupivacaine) . injectable solution 7.5 mg / ml; ampoule polypropylene 10 ml, a pack of cardboard 10; no. лп-003106, 2015-07-21 to 2020-07-21 from ebbvi ltd. (russia); manufacturer: kurida as (norway); packer: abbvi s.r.l. (italy), or ropivacaine kabi (ropivacaine kabi) (ropivacaine) solution for injection 7.5 mg / ml; ampoule polypropylene 1 10 ml, a pack of cardboard 5; ean code: 4607085481524; no. лп-002897, 2015-03-04 to 2020-03-04 from fresenius kabi deutschland gmbh (germany); manufacturer: fresenius kabi norge (norway). both preparations were diluted to a volume of 50 ml, at a concentration of 3 mg / ml. it was performed by tap-block in-plain with a 22g needle quincke, on both sides, and 25 ml on each side was injected. the pain syndrome was assessed with admission, and every 2 hours during the first 12 hours after the operation, using a digital scale on the vas. all patients received nsaids (ketorol 3 mg iv every 6 hours from admission) additionally: paracetamol iv infusion 100 ml with vas = 4 score, lockout time 6 hours tramadol 5% - 2 ml im with vas = or \> 5 score, lockout time 6 hours

Eligibility criteria:
inclusion criteria: * cesarean section pfannenstiel incision under spinal anesthesia * spinal anesthesia with bupivacaine heavy 0,5% * without any adjuvants exclusion criteria: * any other anesthesia exept spinal * any other surgical incision

Keywords: tap-block vas of pain cesarean section postoperative analgesia
assessment of asthma knowledge perception in parents of asthmatic children. pilot study by means of q-kap ( questionnaire on knowledge, attitudes and practices )

Conditions: Asthma

Summary: the aim of this study is to assess the knowledge, the attitudes and the practices of parents of asthmatic children.

the aim of this study is to assess the knowledge, the attitudes and the practices of parents of asthmatic children. the study proposes the validation of q- kap by means of the recruiting of 390 parents of asthmatic children, recruited in the outpatient clinic of pediatric allergology \& pulmonology (pap) of respiratory disease research center (rdrc) within the institute of biomedicine and molecular immunology (ibim) of the national research council (cnr) of palermo (rdrc-ibim cnr), italy. q-kap will be given to one of the parents during their children medical examination. q-kap is a multiple answer questionnaire investigating on knowledge, attitudes and practices for what concerns asthma. at the end of the recruitment time, data will be stored and analyzed in a dataset. the expected result is the identification of a tool able to assess knowledge, attitudes and practices of asthmatic children parents, but also the identification of a tool able to identify two groups of parents (well-experienced and bad-experienced) to assess if there is a link between a low degree of knowledge and a bad control of the disease.

Eligibility criteria:
inclusion criteria: * asthma exclusion criteria: * no consent by parents
measurement and comparison of the occlusive and hydrating capacity of three silicone gels and one gel cream

Conditions: Scar Tissue or Healthy Skin

Summary: study hypothesis: is alhydran gel-cream as efficient as silicone gel for skin occlusion and hydration? for this study 16 volunteers and ten patients with healed full thickness burns will be included. after a short period of acclimatization four test areas will be determined. for healthy volunteers the standard zones are located on the inner forearm, two on each forearm. for patients with healed burns the 4 test zones are located on either the healed donor site or the healed skin grafted area. in each test zone baseline measurements will be taken before application of the products.after application of the three silicone gels and the hydrating gel cream the trans epidermal water loss (tewl) and the moisture content of the stratum corneum will be measured by using the tewameter®tm300 and the corneometer® cm825 (courage \& khazaka).


Eligibility criteria:
inclusion criteria: * healthy volunteers or patients with healed full thickness burns and donor sites * not pregnant * age\>18 years * male or female * written authorisation of the patient or volunteer is required. exclusion criteria: -
corevitas alopecia areata (aa) safety and effectiveness registry

Conditions: Alopecia Areata

Summary: prospective, observational cohort study for subjects with aa under the care of a dermatology provider. approximately 5,000 subjects and 100 clinical sites in north america will be recruited to participate with no defined upper limit for either target.

the objective of the registry is to create a cohort of aa subjects to study long-term safety and effectiveness of aa treatments. because the long-term understanding of safety and efficacy is still limited even after regulatory approval,enrollment and long-term follow-up of a large number of diverse real-world patients exposed to therapies of interest is important to understand safety and effectiveness. the observational structured data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of aa to support ongoing risk benefit evaluation by drug manufacturers and regulators.further, data collected will inform clinical decision making by subjects and treating providers. this will be done through the standardized collection of validated patient-reported outcomes (pro) and clinician-reported outcomes (clinro), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns. personal information is also collected from each consenting registry subject allowing for linkages to other public or private clinical and administrative databases, as well as to databases maintained by organizations focused on the care and treatment of aa for the purposes of clinical, market, or outcomes research. this provides an opportunity to evaluate other aspects of the disease and its treatment including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence.

Eligibility criteria:
inclusion criteria: * a subject must meet all the following criteria to participate in the registry: 1. has been diagnosed with alopecia areata by a dermatologist or a qualified dermatology practitioner. 2. is at least 18 years of age or older. 3. is willing to provide personal information. 4. is prescribed or starting an enrollment eligible medication at the time of enrollment. exclusion criteria: * any of the following would exclude the subject from participating in the registry: 1. is participating or planning to participate in a double-blind randomized trial for an aa drug. note: concurrent participation in another observational registry or open-label phase 3b/4 trial is allowed.
arterial access for coronary intervention in myocardial infarction

Conditions: Myocardial Infarction; Angioplasty, Transluminal, Percutaneous Coronary; Myocardial Reperfusion

Summary: the aim of this study is to compare the radial and femoral access for percutaneous interventions in the acute phase of the st elevation acute myocardial infarction in terms of efficacy and security.

some groups have previously used the radial artery as the access route in the procedures of percutaneous coronary revascularization, with good results. the advantages of the radial compared with femoral access are related to a lower incidence of vascular complications. the radial access has also inconveniences such as a less predictable anatomy which can make the procedure difficult and prolong the time required.the patients with st elevation myocardial infarction have an increased risk of vascular complications after interventional procedures because previous antithrombotic or thrombolytic therapy.on the other hand, the time and success of the procedure are significant prognostic issues.in this sitting, the radial approach might reduce vascular complications and increase other cardiovascular events when comparing with the classical femoral access. for this reason, the purpose of the study is to compare both arterial access in terms of efficacy and security and to quantify the consequences of the advantages and drawbacks of both.

Eligibility criteria:
inclusion criteria: * patients with st elevation acute myocardial infarction referred for primary,facilitated or of rescue coronary angioplasty in the first 12 hours since the start of the symptoms. exclusion criteria: * patients in cardiogenic shock were excluded following operator criteria. * previous coronary surgery with mammary artery graft * coronary artery intervention in the previous month * absolute or relative contraindication for access via the radial artery route:radial pulse absent or weak, abnormal allen test,anatomy known to impede the use of the radial route or hemodialysis or advanced chronic renal insufficiency (creatinine \>3 mg/dl). * patients with absolute or relative contraindication for the use of the femoral route. * absence of informed consent from the patient

Keywords: transradial access femoral access femoral vs radial access
filling key research gaps with clinical implications in mansonellosis and schistosomiasis: a network approach

Conditions: Schistosoma Mansoni

Summary: this is an experimental, multicenter, non-profit study promoted by the department of infectious and tropical diseases of the irccs (istituto di ricerca e cura a carattere scientifico) sacro cuore don calabria of negrar which aims to evaluate the presence of endosymbiont wolbachia in circulating microfilariae obtained from biological samples of individuals infected with m .perstans and the presence of infection with hybrid schistosoma species in the population of schistosoma eggs isolated from biological samples of patients with active schistosomiasis.


Eligibility criteria:
inclusion criteria: * samples from patients who gave consent to the storage and use for research purposes of their samples. in the case a network centre necessitates a template for the storage and use for research purposes of their samples; * samples collected before any treatment with praziquantel and/or benzimidazole and/or avermectin and/or diethylcarbamazine and/or doxycycline drug; * samples collected and stored in conditions suitable for this study (annex 2); * known country of birth of the patient or of most likely infection (if different from the country of birth) exclusion criteria: - no compliance with at least one of the above-mentioned inclusion criteria.
effective pain management of interscalene blocks during shoulder surgery

Conditions: Primary Osteoarthritis, Unspecified Shoulder

Summary: shoulder replacement surgery is recognized as having the potential to cause a considerable amount of postoperative pain. adequate management of pain after surgery is necessary not only to improve the patient's wellbeing but also to facilitate recovery. several regional anesthesia techniques are available to combat postoperative pain in the shoulder replacement surgery patient, however, which method provides superior pain relief remains unknown. the purpose of this study is to examine the effectiveness of a continuous interscalene block versus a single shot interscalene block for postoperative pain relief in the shoulder replacement patient. patients undergoing shoulder replacement surgery will experience more effective pain relief with a continuous interscalene block versus and single shot interscalene block.

this is a prospective randomized controlled trial. 76 patients receiving either primary total shoulder replacement, hemiarthroplasty, or reverse total shoulder replacement will be randomized to a regional anesthesia technique as part of their surgical procedure. 38 patients will receive a single shot interscalene block containing ropivicaine and 38 patients will receive a continuous interscalene block containing ropivicaine.

Eligibility criteria:
inclusion criteria: * surgical candidate for primary total shoulder replacement, hemiarthroplasty, or reverse total shoulder replacement * patient must be 18 years or older and willing to sign and date an institutional review board informed consent form, and * must be able to understand and agree to follow study protocol. exclusion criteria: * severe bronchopulmonary disease, * oxygen dependent, * existing nerve injury, * bmi \> 40, * coagulation disorders, * allergy to ropivicaine, * history of drug or alcohol abuse, * american academy of anaesthesiologists physical status classification \> lll, * pregnant women.
a study of htd1801 in adults with nonalcoholic steatohepatitis (nash) and type 2 diabetes mellitus (t2dm)

Conditions: Fatty Liver, Nonalcoholic; NAFLD; Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis; Digestive System Diseases; Type 2 Diabetes Mellitus (T2DM)

Summary: randomized, double-blind, placebo-controlled, parallel-group study comparing multiple doses of htd1801 to placebo.

this 18-week randomized, double-blind, parallel-group, proof of concept (poc), dose-ranging study compared multiple doses of htd1801 to placebo in a 1:1:1 ratio. since accumulation of hepatic fat is considered the "first hit" in the pathogenesis of nash (adams and angulo 2006), change in liver fat content (lfc) by magnetic resonance imaging estimated proton density fat fraction (mri-pdff) is an appropriate primary endpoint and is consistent with that used in other recent phase 2 poc studies in nash (harrison et al., 2018, madrigal pharmaceuticals 2018). the harrison et al., 2018, madrigal pharmaceuticals 2018 study showed clinically meaningful absolute and relative reductions in lfc assessed by mri-pdff over 12-week treatment periods thus, it was considered that an 18 week htd1801 treatment period would therefore be adequate to assess the study's primary endpoint and to maximize collection of exposure and safety related data.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of nash as assessed by mri * clinically documented diagnosis of t2dm * body mass index (bmi) \>25 kg/m2 exclusion criteria: * liver disease unrelated to nash * poorly controlled t2dm or type 1 diabetes mellitus * history of alcohol or substance abuse or dependence * inability to undergo mri for any reason * history of significant cardiovascular disease
the synergistic effects of integrated neuromuscular inhibition technique and dry cupping therapy on pain modulation and functional recovery on myofascial trigger points of upper trapezius

Conditions: Mechanical Neck Pain

Summary: the purpose of the study is to investigate the synergistic effects of the integrated neuromuscular inhibition technique and dry cupping therapy on pain modulation and functional recovery on myofascial trigger points of the upper trapezius


Eligibility criteria:
inclusion criteria: * medically competent men and women will be included they had chronic mtrps in the upper trapezius for more than 6 months diagnostic criteria of being a tight band with a palpable nodule and distant pain when subjected to pressure exclusion criteria: * subjects with previous neck or shoulder pathology (e.g., fracture, sur¬gery, inflammatory and infectious diseases), cervical disc pathology, systemic disorder, fibromyalgia, those who underwent physical therapy for at least the previous 3 months

Keywords: dry cupping integrated neuromuscular inhibition technique