Kornimate/medical-research-clean huggingface dataset:
corticosteroid injection versus tendon dry needling for subacromial impingement syndrome

Conditions: Shoulder Pain; Shoulder Impingement Syndrome; Shoulder Impingement; Subacromial Impingement Syndrome; Subacromial Impingement

Summary: this randomized clinical trial aims to compare the efficacy of corticosteroid injection and tendon dry needling for the treatment of subacromial impingement syndrome.

this randomized clinical trial will compare the efficacy of corticosteroid injection and tendon dry needling for the treatment of subacromial impingement syndrome.participants will be randomized to receive either a corticosteroid injection or tendon dry needling treatment. the corticosteroid injection group will receive a single subacromial injection of 40mg triamcinolone acetonide under ultrasound guidance. the tendon dry needling group will receive a total of 3 sessions of dry needling treatment to the supraspinatus, infraspinatus, and subscapularis muscle tendons. patients will be assessed before treatment, after treatment, after three weeks and after three months with visual analog scale, shoulder pain and disability index (spadi) and shoulder range of motion measurements.

Eligibility criteria:
inclusion criteria: * adult patients aged 18-65 years old * diagnosis of subacromial impingement syndrome, confirmed by clinical examination and imaging (such as x-ray or mri) * moderate to severe shoulder pain, with a score of at least 4 on a 0-10 visual analog scale (vas) for pain * willingness to comply with the study protocol and attend all study visits and assessments * ability to provide informed consent to participate in the study. exclusion criteria: * contraindications to corticosteroid injection or dry needling, such as local infection, bleeding disorders, or allergy to the injectate or needle * previous shoulder surgery on the affected shoulder * other active shoulder conditions, such as rotator cuff tear or adhesive capsulitis, that may confound the study results * systemic conditions, such as rheumatoid arthritis or osteoarthritis, that may affect the shoulder joint and its function * history of shoulder dislocation or instability * pregnancy or breastfeeding * current use of systemic corticosteroids or immunosuppressive drugs * injection to shoulder area in the past six months. * inability to complete the study assessments or follow the study protocol, such as due to cognitive impairment or language barrier.
acurate ta™ valve implantation: savi registry (surveillance plan #2011-02) (ta-savi)

Conditions: Symptomatic Aortic Stenosis

Summary: post-market registry on acurate ta™ transapical aortic bioprosthesis and acurate ta™ delivery system implantation in patients presenting severe symptomatic aortic stenosis to provide safety surveillance of the device.

a single arm, prospective, multicenter, non-randomized and open registry up to 1 year follow-up with the symetis acurate ta™ which is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where surgical aortic valve replacement (savr) via open surgery is considered to be associated with high surgical risk for evaluating the safety and performance of the implantation and the safety at 30-day follow-up.

Eligibility criteria:
inclusion criteria: * patient has severe aortic stenosis * native aortic annulus diameter from ≥ 21mm up to ≤ 27mm * patient willing to participate in the study and provides signed ec-approved informed consent * the subject and treating physician agree the subject will return for all required post-procedure follow-up visits exclusion criteria: * patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the acurate ta™ and delivery system as per the instructions for use.

Keywords: severe symptomatic aortic stenosis
effect of resistance training associated with whole-body vibration in diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: introduction: diabetes mellitus (dm) is an important health condition of the population and its prevalence continues to grow due to population aging, economic development and urbanization. the exercise is an important factor of prevention and control, thereby decreasing the risk of metabolic diseases, cardiovascular diseases and improving the functionality of the patient with diabetes. objective: evaluate the response of resistance training associated with whole-body vibration on peripheral circulation and functional performance of elderly with type 2 diabetes. methods: this is a clinical trial study, controlled, randomized and blinded, which will follow the guidelines established by the consolidated standards of reporting trials (consort). patients will be recruited in the light of the eligibility criteria and randomly divided into 3 groups: resistance training associated with whole body vibration (g1), resistance training associated with vibration sham (g2) and control group-guidelines about foot care (gc), establishing 36 treatment sessions, three times a week for the g1 and g2.


Eligibility criteria:
inclusion criteria: * present overweight or obese class i, with bmi between 25.00 and 34.99 kg/m2 (who, 2009) * be functionally independent * having cognitive ability to respond and perform the exercisesevaluated by mini-mental state examination (mmse), prepared by folstein et al. (1975) and translation/modification proposed by lawrence and van heerden (2006), using as a bridge to cut to illiterate individuals = 19 points (brazil, 2006) * inactive (0 to 5 points) or less active (6 to 11 points) according to the questionnaire of habitual physical activity (qafh) * patients without severe foot deformities requiring therapeutic shoes * do not have orthopedic deficiencies * no indications of deep vein thrombosis * do not use locomotion auxiliary equipment exclusion criteria: * change in the drug program in during the research * performing other physical activity during the training * hypertensive peaks during treatment

Keywords: diabetes mellitus blood flow velocity skin temperature postural balance combined modality therapy vibration resistance training
the use of a morcellator in operative hysteroscopy for benign intracavitary lesions: a feasibility study

Conditions: Endometrial Polyp Benign; Retained Products of Conception; Myoma;Uterus

Summary: polyps, intracavitary myomas and retained products of conception (rpoc) are common benign intracavitary lesions of the uterus and frequently cause abnormal uterine bleeding or pain. in general, intracavitary lesions are treated by operative hysteroscopy with bipolar resectoscopic removal under general anaesthesia, performed in the theatre (or). potential problems with this approach are thermal damage and impairment of visibility due to loose tissue fragments necessitating multiple entries for tissue removal. recently, lesion morcellation by hysteroscopy has been introduced as an alternative technique. compared to the resectoscopic approach, morcellation is reportedly associated with a shorter total procedure time, smaller fluid deficit and number of insertions. a few trials also registered a higher success rate in completeness of resection. no significant differences in odds of surgical complications have been reported. most hysteroscopic morcellators have diameters up to 8 mm, for which cervical dilation under general anaesthesia is usually needed. recently, companies have developed hysteroscopic morcellators with smaller diameters, e.g. 6.3 mm for the 19 fr. intrauterine bigatti shaver (ibs®). this means less need for cervical dilation, and potential use without anesthesia. at this moment, there are no prospective studies available on feasibility of the 19 fr. intrauterine bigatti shaver (ibs®). before implementing hysteroscopic morcellation in our department, we need a feasibility study assessing the method in standard conditions in the operation room or in ambulatory setting under sedation. trial objectives: assessment of the feasibility of hysteroscopic morcellation of benign uterine intracavitary lesions. the primary objective is to assess the completeness of hysteroscopic resection in patients undergoing the procedure under general anesthesia or sedation. secondary objectives are to assess perioperative parameters as operation time, need for cervical dilation, adverse events, pain, operator satisfaction; to assess quality of tissue for histological examination; to assess postoperative complications and pain.


Eligibility criteria:
inclusion criteria: * patients: * female ultrasonographic diagnosis of an intracavitary lesion, according the ieta terms and definitions * endometrial polyp * figo 0-1 myoma (maximum diameter 2 cm) * rpoc (maximum diameter 2 cm, no enhanced myometrial vascularity) exclusion criteria: * • active vaginal bleeding * (possible) malignancy * \< 18y * patient refusal * pregnancy * impossibility to access the uterine cavity (e.g. severe cervical stenosis) * absence of intracavitary lesion (endometrial polyp, figo 0-1 myoma or rpoc) at hysteroscopy

Keywords: endometrial polyp hysteroscopic surgery morcellation retained products of conception myoma
impact of 3-year lifestyle intervention on postprandial glucose metabolism: the slim study

Conditions: Impaired Glucose Tolerance; Type 2 Diabetes

Summary: to evaluate the effect of a 3-year diet- and exercise lifestyle intervention, based on general public health recommendations, on glucose tolerance, insulin resistance and metabolic cardiovascular risk factors in dutch subjects with impaired glucose tolerance (igt).

objective to evaluate the effect of a 3-year diet- and exercise lifestyle intervention, based on general public health recommendations, on glucose tolerance, insulin resistance and metabolic cardiovascular risk factors in dutch subjects with impaired glucose tolerance (igt). research design and methods 147 igt subjects (75 male, 72 female) were randomized to the intervention group (int) or control group (con). 106 subjects (52 int, 54 con) completed 3 years of intervention. annually, glucose, insulin and ffa concentrations were determined during fasting and after an oral glucose tolerance test, in addition to measurements of body weight, serum lipids, blood pressure and maximal aerobic capacity.

Eligibility criteria:
inclusion criteria: * caucasion,age 40-70, mean 2hr glucose 7.8-12.5 mmol/l, mean fasting blood glucose below 7.8 exclusion criteria: * known type 2 diabetes, mean 2hr glucose \>12.5 mmol/l, mean fasting blood glucose \> 7.8 mmol/l, chronic illness that makes 5-year survival improbable, interferes with glucose tolerance or makes participation in a lifestyle intervention impossible, medication known to interfere with glucose tolerance, participation in a vigorous exercise and/or diet program

Keywords: impaired glucose tolerance type 2 diabetes
using immersive virtual reality for the upper limb rehabilitation of post-stroke subjects

Conditions: Sub-acute Stroke

Summary: stroke produces brain damages that results in sensory, motor, and cognitive impairments which reduce the patient's quality of life and social participation. upper limb recovery is a complex process whose goal is to allow the patients to gain, in part or completely, independence in daily living activities, for that it represents one of the most important rehabilitation focus. virtual reality is a fairly recent approach able to simulate concrete movements and functional tasks in a higher dosage compared to other therapies. it seems that the use of vr could improve limb function, however, the amount of this gain is still unclear because of insufficient evidence. this study aims at quantitatively investigating the effectiveness of an hmd immersive virtual reality system on the upper limb functioning in subacute stroke survivors.


Eligibility criteria:
inclusion criteria: * diagnosis of first, ischemic or hemorrhagic, stroke verified by brain imaging within 4 week * upper limb motor impairment defined by an upper extremity score \<55 on the fugl-meyer assessment exclusion criteria: * neurological conditions in addition to stroke that may affect motor function * other medical conditions likely to interfere with the ability to safely complete the study protocol * impaired cognitive functioning that influences the ability to give informed consent * severe neuropsychological disorders * visual impairment * severe upper-limb pain defined as \> 7 on the visual analogue scale

Keywords: stroke rehabilitation upper limb immersive virtual reality head-mounted display subacute stroke
mirikizumab administered at the same time as tirzepatide in adult participants with moderately to severely active ulcerative colitis and obesity or overweight: phase 3b study

Conditions: Ulcerative Colitis; Obesity or Overweight

Summary: the main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to decrease or disappearance of uc symptoms, and loss of at least one-tenth of the overall body weight. participation in this study will last up to 61 weeks, including 52 weeks of treatment.


Eligibility criteria:
inclusion criteria: * have had an established diagnosis of uc for ≥3 months before baseline which includes endoscopic evidence of uc and a histopathology report that supports a diagnosis of uc. * have moderately to severely active uc as defined by a modified mayo score (mms) of 5 to 9 points and endoscopic subscore (es) of 2 to 3 (confirmed by central review) within 21 days before baseline. * participants with a history of uc for greater than or equal to 8 years who have had a surveillance colonoscopy completed within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer. * have obesity, \[body mass index (bmi) 30 kilograms per meter squared (kg/m2)\] * have overweight (bmi ≥27 kg/m2 to \<30 kg/m2) and in the presence of at least 1 of these weight-related comorbid conditions: * hypertension * type 2 diabetes mellitus (t2dm) * dyslipidemia * obstructive sleep apnea, or * cardiovascular disease. * have an inadequate response to, loss of response to, or intolerance to at least 1 of the conventional medication: oral corticosteroids, oral azathioprine (aza) or 6-mercaptopurine (6-mp), or oral 5-aminosalicylates (for example, mesalamine, sulfasalazine, olsalazine, and balsalazide) and/or who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for uc, defined as: a biologic or biosimilar medication such as anti-tumor necrosis factor (tnf) antibodies; anti-integrin antibodies, janus kinase (jak) inhibitors such as tofacitinib or upadacitinib, sphingosine 1-phosphate receptor 1inhibitors such as etrasimod or ozanimod, or anti-interleukin(il)-12p40 antibodies, for example, ustekinumab. exclusion criteria: * have a current diagnosis of: * crohn's disease * inflammatory bowel disease (ibd) unclassified (formerly known as indeterminate colitis), or * primary sclerosing cholangitis. * have had or will need bowel resection or intestinal or intra-abdominal surgery. * have evidence of toxic megacolon, or stricture or stenosis within the colon that cannot be traversed by a sigmoidoscope or colonoscope. * have a diagnosis of type 1 diabetes mellitus (t1dm) or have insulin-treated t2dm. * have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening. * have a self-reported change in body weight greater than 5% (gain or reduction) within 3 months prior to screening. * have a current or recent acute, active infection.
long-term treatment study of mra for rheumatoid arthritis (ra) from study mra220jp or mra221jp

Conditions: Rheumatoid Arthritis

Summary: this is an open-label, extension, phase iii study to evaluate the long-term safety and efficacy of mra in patients with ra who participated in study mra220jp or mra221jp.


Eligibility criteria:
inclusion criteria * ra patients who participated in the previous studies * patients who completed the last observation in the previous studies * patients who were confirmed to have no problems with safety in the previous studies. exclusion criteria * patients with class iv steinbrocker functional disorder at evaluation within 4 weeks before treatment with the investigational product * patients who were not enrolled by 3 months after the last observation day of the previous study
clinical evaluation of a wearable sleep diagnosis technology

Conditions: Obstructive Sleep Apnea

Summary: the primary endpoint is to evaluate the sensitivities and specificities for diagnosis of sleep apnoea of a wearable sleep diagnosis technology vs. existing gold standard.

the clinical investigation will be performed at the royal free london hospital. physiological signals will be pseudo-anonymized and only viewed by the research team. the study will involve patients who will have been referred for diagnosis of sleep apnoea, will aim to determine acupebble's positive and negative predictive ratios, sensitivities as specificities. likelihood ratios for diagnosis of sleep apnoea. clinical experts will determine patients' diagnostic information using the current diagnostic standards. acupebble will also generate diagnostic results independently and automatically. both set of results will be subsequently compared and the relevant performance metrics listed above will be determined. consecutive patients referred for sleep study will be recruited to the study. patients that are willing to participate will be consented on the day of their sleep study and sent home with both - the trusts usual multichannel polygraphy and the acupebble.

Eligibility criteria:
inclusion criteria: * patients who have been referred to a sleep clinic due to suspicion of sleep apnoea. exclusion criteria: * age under 18 or over 70 years. * subjects who are not fluent in english, or who have special communication needs. * known allergy to the adhesive dressing. * subjects with physical or mental impairments who would not be able to use the new technology on their own. * subjects with very loose/saggy skin in the neck area which would unavoidably result on - acupebble swinging if moving the neck. * subjects with pacemakers. * exclude patients who have any type of implanted electronic devices (these include patients in icds and left ventricular assist devices and loop recorders).
effects of preanesthetic forced air warming and administration of warmed intravascular fluid

Conditions: Pregnancy

Summary: the majority of women (\> 60%) developed hypothermia and shivering during cesarean delivery. core hypothermia may be associated with a number of adverse outcomes in patients, including shivering, wound infection, coagulopathy, increased blood loss and transfusion requirements, decreased metabolism and prolonged recovery. shivering can result in interference with monitoring, increased tension on wound edges, and increased oxygen consumption. a previous study has shown several modalities to prevent hypothermia and shivering in patients undergoing cesarean delivery with spinal anesthesia. but, single modality intervention have shown marginal or no efficacy. neuraxial anesthesia reduces the threshold for vasoconstriction and shivering. it often also produces a lower body sympathectomy that provokes a core to peripheral redistribution of body heat. it is difficult to treat the core to peripheral redistribution of body heat. however redistribution can be prevented by preanesthetic cutaneous warming. prewarming hardly changes core temperature that remains well regulated, but it markedly increases peripheral tissue heat content. as a result, prewarming reduces the core to peripheral tissue temperature gradient and the propensity for redistribution after the induction of anesthesia. we therefore hypothesized that combined modality active warming consisting of preoperative 15 min of surface warming using a forced air warmer before spinal anesthesia and coloading of warmed intravenous fluid might reduce perioperative hypothermia and shivering in women undergoing cesarean delivery. additionally, we tested the hypothesis that maintaining maternal normothermia increases newborn temperature and apgar scores.


Eligibility criteria:
inclusion criteria: * patients scheduled for cesarean delivery under spinal anesthesia * the american society of anesthesiologists physical status class one or two * female between 20 and 45 exclusion criteria: * patients with heart disease * patients with infectious disease * patients with coagulopathy * patients with a drug allergy * in case of switching to general anesthesia * patients bmi under 18.5 or over 31

Keywords: cesarean delivery with spinal anesthesia hypothermia and shivering active warming
a psoriasis plaque test comparing eight different formulations of vitamin d analogues for the treatment of psoriasis

Conditions: Psoriasis Vulgaris

Summary: the purpose of this trial is to compare the anti-psoriatic effect of eight different formulations of vitamin d analogues using a psoriasis plaque test design


Eligibility criteria:
inclusion criteria: * subjects having understood and signed an informed consent form. * either sex * age 18 years or above * all skin types and any ethnic origin * subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk. exclusion criteria: * females who are pregnant, or who wish to become pregnant during the study, or who are breast feeding * systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation * systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin d analogues, retinoids, immuno-suppressants) within the 4-week period prior to randomisation * subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the study: * potent or very potent (who group iii-iv) corticosteroids * puva or grenz ray therapy * subjects using one of the following topical drugs for the treatment of psoriasis within two weeks prior to randomisation and during the study: * who group i-ii corticosteroids (except if used for treatment of scalp psoriasis) * topical retinoids * vitamin d analogues * topical immunomodulators (e.g. macrolides) * anthracen derivatives * tar * salicylic acid * uvb therapy * subjects known to be non-responder to topical vitamin d analogues (e.g., known history of no improvement or worsening of psoriasis with e.g., calcipotriol, calcitriol or tacalcitol when used according to current smpc) * subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments) * subjects with current participation in any other interventional clinical, based on interview of the subject * subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis * subjects with known or suspected hypersensitivity to component(s) of the investigational products * subjects with known/suspected disorders of calcium metabolism associated with hypercalcaemia * subjects with known severe hepatic and/or severe renal insufficiency * subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis