Kornimate/medical-research-clean huggingface dataset:
cognitive activation therapy for mci: a randomized control study

Conditions: Mild Cognitive Impairment

Summary: mild cognitive impairment (mci) describes an initial phase of cognitive decline, usually among older adults, in which a person notices a decline in attention or memory, and performs worse than normal on cognitive tests of such. people with mci are more likely to develop alzheimer's disease or related dementia than others their same age, and so mci is thought of as an early warning sign of progressive cognitive decline. while some forms of mci may be brought about by purely genetic causes, other cases may be due to a withdrawal of cognitive engagement with the world. in these cases, a rigorous program of cognitive training may be beneficial, halting or reversing symptom progression. the current study will evaluate a multifaceted cognitive activation program on older adults with mci. this group program is intensive, running for 10 weeks, 3 times per week, for a total of 100 hours of training. training consists of meditation exercises for broad attention activation, tai chi exercises to integrate cognition with body awareness, and cognitive training through computerized attention, memory, and problem solving exercise. subjective impressions and objective measures of cognitive ability will be measured before and after the intervention. the investigators will also examine effects on mood and levels of daily function. results will be compared to a waitlisted control group. the control group will subsequently be entered into a home-based version of the program for 10 weeks, with assessment before and after training, to look at the importance of the group meeting dynamic in promoting cognitive change.


Eligibility criteria:
inclusion criteria: * subjective complaint about decline in memory or attention * \> 1 deviation below age-norm performance on memory or attention tasks * independence in daily living * english speaking exclusion criteria: * neurological disorders (including aphasias) or reversible causes of dementia (e.g., hypothyroidism or b12 deficiency) * montreal cognitive assessment (moca) score \< 24 * clinical mood disorder such as depression or anxiety * other serious medical conditions that preclude participation in the program

Keywords: mild cognitive impairment mci meditation mindfulness cognitive activation cognitive training tai chi
study of capsaicin patch for the management of peripheral neuropathic pain

Conditions: Peripheral Nerve Injury; Postherpetic Neuralgia

Summary: the efficacy and safety of the low concentration \[0.65% (50 µg/cm2) and 1.25% (100 µg/cm2)\] capsaicin patches and compared them to conventional 0.075% capsaicin cream and placebo patch in patients suffering from peripheral neuropathy


Eligibility criteria:
inclusion criteria: * patients who are 18 years of age or older aged having chronic peripheral neuropathy related with a diagnosis of either phn or dpn * patients with chronic peripheral neuropathic pain for more than 3 months with an 11-pointed numeric rating scale (nrs) pain score ≥ 4 * patients with a diagnosis of phn were eligible if at least 3 months had elapsed since shingles vesicle crusting * patients with dpn and well controlled diabetes were asked to maintain a stable dose of oral hypoglycemic or insulin during the study period * patients taking concomitant pain medications such as anticonvulsants, antidepressants, anxiolytics, and opioids including tramadol were required to maintain a stable dose for at least 4 weeks before the study enrollment * any conservative therapies such as tens, physical therapy, chiropractic, massage, biofeedback, or yoga were stopped at least 5 weeks before the enrollment * women of childbearing age were required to have a negative pregnancy test and were to be willing to use an effective method of contraception for at least 28 days after the last exposure to study medication exclusion criteria: * diffusely distributed neuropathic pain resulting from spinal stenosis, postoperative origin, complex regional pain syndrome, or genetic neurological disease, or significant pain outside the target area * significant pain of an etiology other than phn or dnp * other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or with investigational product administration or may interfere with compliance or the interpretation of study results andin the judgment of the investigator would make the subject inappropriate to participate in the study * painful phn areas located on the face or above the scalp hairline * an implanted medical device for the treatment of neuropathic pain * use of topically applied agents including capsaicin-containing products, a 5% lidocaine patch or similar products, local anesthetics, or steroids within the past 21 days * hypersensitivity known to capsaicin; current use of any class 1 anti-arrhythmic drug; and uncontrolled diabetes mellitus or uncontrolled hypertension * if patients have taken oral nsaid or cox2 inhibitor, it should be stopped at least2 weeks before randomization; however acetaminophen for pain control was allowed up to 4g per day

Keywords: peripheral nerve injury postherpetic neuralgia
incidence of deep vein thrombosis at doppler echo in covid-19 patients with sars-cov-2 pneumopathy hospitalized in icu

Conditions: Deep Vein Thrombosis

Summary: the main objective of the study is to determine the incidence of deep vein thromboses at doppler echo in patients with sars-cov-2 pneumopathy upon their entry into icu and after 7 days of hospitalization in icu. this is a monocentric interventional study (riph 2).


Eligibility criteria:
inclusion criteria: * patient \> or =18 years * hospitalization in intensive care * pcr covid 19+ or compatible clinical signs (fever, cough, myalgia, asthenia, loss of taste, anosmia) associated with compatible radiological signs exclusion criteria: * pregnancy in progress * patient \<18 years * patients deprived of freedoms or under guardianship * patient or family opponent of protocol participation * patient on curative anticoagulant for more than 48h00 * impossible venous doppler echo

Keywords: deep vein thrombosis doppler echo sars-cov-2 icu
avonex-evaluation of quality of life and convenience in belgian participants - the avail study

Conditions: Multiple Sclerosis

Summary: the primary objective is to assess the quality of life of intramuscular (im) interferon beta-1a in participants with relapsing remitting multiple sclerosis (rrms) or clinically isolated syndrome (cis) in a clinical practice setting.


Eligibility criteria:
key inclusion criteria: * decision to treat with interferon beta-1a (ifn beta-1a) must precede enrollment, independently of the study and in compliance with the marketing authorization * study enrollment must occur prior to 4th weekly administration of ifn beta-1a * able to understand and complete a self-administered questionnaire * no contra-indications for ifn beta-1a key exclusion criteria: * subjects with history of hypersensitivity to natural or recombinant ifn beta or to any component * subjects with primary or secondary progressive ms * subjects with current severe depression and/or suicidal ideation * pregnant women * subjects participating in another clinical trial * subjects who do not want to participate in the study note: other protocol defined inclusion/exclusion criteria may apply.
e- predict: ebus elastography strain in lung cancer

Conditions: Lung Cancer

Summary: ebus elastography is a method to determine stiffness of lymph nodes, based on the minute deformation of the node by the beating heart. whether ebus elastography may further increase the sensitivity to predict the presence or absence of malignancy is unclear. we suggest to use ebus elastography strain pattern analysis for this assessment and correlate these measurements with the final pathology outcome to determine npv, ppv, sensitivity and specificity of this analysis to predict the presence or absence of malignancy in patients with (suspected) lung cancer in a prospectively obtained observational cohort study.

patients will undergo a routine ebus and/or eus or eusb with pentax series ebus or eus scopes in combination with hitachi preirus hi-vision ultrasound processor with installed elastography software. normal international guidelines for staging, diagnosis and specimen acquisition will be followed. for a normal evaluation b-mode measurements from all lymph node regions are obtained assessing size and standard ultrasound characteristics and all lymph nodes in the regions of interest that meet the criteria for fine needle aspiration will be sampled. for this study, in addition to the normal b-mode assessment of five sonographic b-mode characteristics elastography strain graph video, elastography image, and a strain histogram from the region of interest will be obtained. fine needle aspiration for cytology evaluation will be obtained from nodes based on imaging characteristics or standard sonography characteristics following current everyday clinical practice and the international guidelines. subsequently, the patient charts will be retrospectively analysed after completion of the diagnostic and/or surgical treatment of the (suspected) lung cancer to match the obtained imaging data to pathology results (cytology and or histology where present) and clinical follow up until 6 months after the diagnostic procedure.

Eligibility criteria:
inclusion criteria: * patients with indication for diagnostic or staging ebus procedure for suspected or proven lung cancer. * asa physical status 1-3. * age 18 years or older. exclusion criteria: * bleeding disorders. * contra-indication for temporary interruption of the use of anticoagulant therapy (acenocoumarol, warfarin, therapeutic dose of low molecular weight heparines or clopidrogel). * known allergy for lidocaine. * uncontrolled pulmonary hypertension. * recent and/or uncontrolled cardiac disease. * compromised upper airway (eg concomitant head and neck cancer or central airway stenosis for any reason). * prior radiotherapy treatment involving the central airways * asa classification greater than or equal to 4. * pregnancy. * inability to consent.

Keywords: nsclc ebus elastography predictive value strain
effects of moderate physical activity on diabetic adhesive capsulitis: a randomized clinical trial

Conditions: Adhesive Capsulitis of Shoulder

Summary: the study is designed to determine the effects of moderate physical activity on adhesive capsulitis in patients with uncontrolled diabetes mellitus.

this study aims to investigate the effect of additional physical activity programmes in patients with diabetic frozen shoulder (dfs). physical activity can help people with diabetes achieve a variety of goals, including increased cardiorespiratory fitness, increased vigour, improved glycemic control, decreased insulin resistance, improved lipid profile, blood pressure (bp) reduction and maintenance of weight loss frozen shoulder syndrome, also known as adhesive capsulitis, is a clinical entity that refers to a stiff and painful shoulder causing major functional impairment. it affects women more than men, and is mostly associated with diabetes mellitus as a systemic condition. . frozen shoulder may be either primary idiopathic or secondary to a systemic disease, such as diabetes mellitus. the adoption and maintenance of physical activity are critical for blood glucose management and overall health in individuals with diabetes. in this position statement, we provide a clinically oriented review and evidence based recommendations regarding physical activity and exercise in people with type 2 diabetes.

Eligibility criteria:
inclusion criteria : 1. the male and female physically active with uncontrolled diabetic (\>6.5% hba1c) patients those taking medicine to controlled it from more than 3 years. 2. the age of the participants will be between 40 to 65-years, 3. having stage 1 or 2 adhesive capsulitis (ac) with a capsular pattern included in the study. exclusion criteria: 1. the patients with history of shoulder dislocation 2. lower limb injury, 3. diabetic foot ulcer, 4. diabetic neuropathy, 5. acute or chronic heart disease, 6. rheumatologic disorder 7. mobility disorder and post-surgical or trauma related patients will be excluded during the screening.
clinical study to evaluate the possible efficacy of nifuroxazide in patient with ulcerative colitis

Conditions: Inflammatory Bowel Diseases

Summary: ulcerative colitis (uc) is one of the most common types of chronic and non-specific inflammatory bowel diseases (ibd). it is characterized by cytokine-induced continuous and diffuse inflammatory infiltrations into the rectum's mucosa and extends proximally to the colon. patients with uc predominantly have bloody diarrhea, abdominal pain, fecal urgency, and tenesmus, which extremely alters their quality of life. although the precise pathological mechanism of uc remains unclear, several studies have been outlined many factors that could involve in the pathogenesis of uc, including, but not limited to, initiation of the inflammatory response, disruption of oxidant/antioxidant status, dysregulation of the immune response, alteration of gut microbiota, and delaying epithelial barrier healing. loss of intestinal barrier function and dysregulated immune response are the key events during colitis development


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * both male and female will be * mild and moderate uc patients diagnosed and confirmed by endoscope exclusion criteria: * breast feeding * significant liver and kidney function abnormalities * colorectal cancer patients * other inflammatory bowel diseases (cd). * patients with severe uc * patients taking rectal or systemic steroids * patients taking immunosuppressives or biological therapies * addiction to alcohol and / or drugs * known allergy to the fenofibrate
population based intervention to prevent obesity in kindergartens (tigerkids)

Conditions: Obesity

Summary: behavioral intervention at kindergarten setting aiming at increased fruit and vegetable consumption, decreased intake of high energy foods, snacks, sweets, increased intake of water/low energy drinks, decreased intake of high energy drinks. physical activity should be more than 1 hour/day and tv/media consumption less than 1 hour/day. main questions are: do children differ in intervention and control kindergartens according to their nutrition behaviour? do children in the intervention kindergartens have a higher physical training than such in the control kindergartens? data were collected with a standardised questionnaire. do children differ in intervention and control kindergartens according to their body mass index?

the program is based on actual cognitions and methods of the early education science. in the initial phase study part i (2003-2006) we will study over three years in 75 kindergartens of four administrative districts in bavaria, germany: bamberg, günzburg, ingolstadt and schwandorf. the objective of the study part ii is to evaluate the effects of the tigerkids intervention program on overweight prevalence in childhood. data concerning bmi, nutrition behavior and physical activity are assessed both at baseline (september/october 2007) and after 10 months intervention in \> 450 control- and intervention-kindergartens in bavaria.

Eligibility criteria:
inclusion criteria: * infant of intervention- or control-kindergarten exclusion criteria: * absence of parenteral consent to participate

Keywords: infant kindergarten obesity adiposity
postoperative pain after intravenous vitamin c injection for arthroscopic rotator cuff repair

Conditions: Rotator Cuff Tear

Summary: 1. treatment of rotator cuff tear the rotator cuff tear is the most demanding part of the shoulder surgery. rotator cuff degeneration is thought to be the largest cause of rotator cuff tear. as the field of shoulder surgery evolves, the diagnosis and surgical treatment of the rotator cuff tear was increased. repair and reconstruction of the rotator cuff tear annually more than 300,000 have been performed according to us statistics. rotator cuff repair is a successful procedure, both objectively and subjectively, with regard to pain relief and functional outcome. 2. postoperative pain management after rotator cuff repair shoulder surgeries are associated with a level of postoperative pain requiring opioid use for several days. the opioid requirements after shoulder surgery have been reported to be similar to those required after gastrectomy or thoracotomy, which might cause several opioid-related side effects, such as nausea and vomiting, pruritus, urinary distention, and constipation. although the introduction of arthroscopy has reduced postoperative pain, a considerable proportion of patients suffer from moderate to severe acute postoperative pain, as its benefit is typically apparent after a few days. consequently, proactive pain control is also required during the first 24-48 h after arthroscopic shoulder surgeries, just like in open surgeries. adequate pain management during the immediate postoperative period is not only important for patient satisfaction and well-being, but also for facilitating postoperative rehabilitation and preventing persistent postsurgical pain. recently preoperative intravenous vitamin c has shown to increase the analgesic effect after otorhinolaryngologic surgery and thoracic surgery. vitamin c is a water-soluble and known to have anti oxidant action, and fewer side effects. however, there is no report about the analgesic effect of vitamin c after arthroscopic rotator cuff repair. the purpose of this trial was to compare the effects of a intravenous vitamin c injection on postoperative pain and opioid consumption versus non-treated group after arthroscopic rotator cuff repair.


Eligibility criteria:
inclusion criteria: * rotator cuff tear patients undergoing arthroscopic rotator cuff tear exclusion criteria: * age \ 80 * allergies to medications used in the study * history of renal diseases, a coagulation abnormality, a hepatic disease, or drug abuse * definite radiographic evidence of osteoarthritis of the glenohumeral joint * inflammatory arthritis including rheumatoid arthritis * a history of acute trauma * systemic conditions associated with chronic pain * a history of infection * an inability to understand the questionnaires

Keywords: rotator cuff repair vitamin c postoperative pain
prediction of the sepra diabetes trial in healthcare claims data

Conditions: Diabetes Mellitus, Type 2

Summary: investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. the investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

this is a non-randomized, non-interventional study that is part of the rct duplicate initiative (www.rctduplicate.org) of the brigham and women's hospital, harvard medical school. it is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. investigators assume that the rct provides the reference standard treatment effect estimate and that failure to replicate rct findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original rct finding.

Eligibility criteria:
all patients will be required to have continuous enrollment during the baseline period of 180 days before initiation of semaglutide or standard of care (sgl2i, 2nd generation su, dpp-4i and glp-1 ra except for semaglutide inj or oral) (cohort entry). eligible cohort entry dates: market availability of semaglutide/standard of care in the us started on december 6th, 2017: * for optum: december 6, 2017 - may 31, 2021 (end of data availability) inclusion criteria: * age \>= 18 * type 2 diabetes mellitus diagnosis * use of metformin * at least 2 hba1c records within the prior 280 days * at least 1 hba1c record within the prior 90 days exclusion criteria: * missing age or gender * use of any other anti-diabetes medications * any insulin use * pregnancy * multiple endocrine neoplasia syndrome type 2 * ckd stage 5, esrd, dialysis, or renal transplant * nursing home admission
spaceoar system pivotal study

Conditions: Prostate Cancer

Summary: evaluate the safety of the spaceoar system when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (ig-imrt)

the purpose of this study is to evaluate the safety of the spaceoar system when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (ig-imrt) and to evaluate whether use of the spaceoar hydrogel results in a reduction of radiation exposure to the anterior rectum.

Eligibility criteria:
inclusion criteria: * subjects greater than 18 years old * subjects must have pathologically confirmed invasive adenocarcinoma of the prostate and must be planning to undergo imrt * subjects must have clinical stage t1 or t2 as determined from a biopsy taken within 6 months of the baseline/screening visit with gleason score less than or equal to 7 * subjects screening/baseline laboratory testing must meet the following laboratory value criteria: psa less than or equal to 20 ng/ml,hematocrit greater than 30%,serum creatinine less than 2.0 mg/dl, serum ast and alt less than 2.5 times upper limit of institution normal, and serum bilirubin less than 2.0 mg/dl * subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate institutional review board (irb) of the respective clinical site exclusion criteria: * prostate greater than 80cc documented within 3 months preceding the screening/baseline visit * subjects with extracapsular extension of the prostate cancer, with greater than 50% of the number of biopsy cores positive for cancer, metastatic disease, other ongoing cancers which will be treated during the study, or subjects for whom pelvic lymph node radiotherapy is planned * subjects with any prior invasive malignancy (except non-melanomatous skin cancer) unless the subject has been disease free for a minimum of 5 years. * subjects who are indicated for androgen deprivation therapy or who have been treated with androgen therapy within the prior 3 months.

Keywords: prostate cancer spacer
botox® treatment in pediatric lower limb spasticity

Conditions: Pediatrics; Muscle Spasticity; Cerebral Palsy

Summary: this study will evaluate the safety and efficacy of botox® (botulinum toxin type a) in pediatric patients with lower limb spasticity.


Eligibility criteria:
inclusion criteria: * minimum weight of 10 kg/22 lb * cerebral palsy with dynamic muscle contracture /spasticity of the ankle exclusion criteria: * muscular dystrophy, myasthenia gravis, eaton-lambert syndrome, amyotrophic lateral sclerosis, or mitochondrial disease * uncontrolled epilepsy * botulinum toxin therapy of any serotype for any condition within the last 6 months * history of surgical intervention of the lower study leg or planned surgery of any limb during the study * previous casting of the study limb for spasticity within 6 months or with a dynamic splint within 3 months, or planned casting or dynamic splinting for spasticity of the study limb or affected upper limb during the study