Kornimate/medical-research-clean huggingface dataset:
comparing real-time fmri neurofeedback versus sham for altering limbic and eating disturbances in anorexia nervosa

Conditions: Anorexia; Anorexia Nervosa

Summary: the goal of the purposed research is to extend prior work (study00003758: real-time fmri neurofeedback to alter limbic disturbances in anorexia nervosa) on real-time fmri (rt-fmri) neurofeedback (focused on amygdala down-regulation) as an innovative neurocircuitry-targeted intervention for anorexia nervosa (an). this project will include randomization to rt-fmri or a sham controlled group to answer the following important unresolved question: does a patient-led procedure aimed at altering brain activity impact limbic circuit function and key eating disorder and psychiatric symptoms in an above the effect of a matched, but non-targeted sham condition?

aim 1: establish that rt-fmri neurofeedback of limbic activity can correct neural disturbances in an. hypothesis 1: compared to the sham group, the amygdala neurofeedback group will show reduced amygdala activation to aversive images, which will increase with repeated training. this effect will generalize to non-neurofeedback test runs. hypothesis 2: compared to the sham group, the amygdala neurofeedback group will exhibit enhanced task and resting amygdala-prefrontal cortex (pfc) connectivity, which will increase with repeated training. enhanced amygdala-pfc connectivity will be associated with less amygdala reactivity to aversive images during the emotion regulation task. aim 2: identify the impact of rt-fmri neurofeedback targeting limbic functioning on symptoms of an. hypothesis 1: compared to the sham group, the amygdala neurofeedback group will exhibit improvements in self-reported emotion regulation and eating disorder symptoms over the study visits. hypothesis 2: compared to the sham group, the amygdala neurofeedback group will engage in less restrictive eating (i.e., will consume more calories) at a post-training test meal. hypothesis 3: across groups, decreased aversive amygdala reactivity and enhanced amygdala-pfc connectivity will predict reduced emotion dysregulation and eating disorder symptoms, and less restriction.

Eligibility criteria:
inclusion criteria: * dsm-5 diagnosis of an, with the exception of body image disturbance and intense fear of weight gain * ability to read and speak in english * right-handed exclusion criteria: * medical instability or current pregnancy (self-reported) * acute suicidality, current substance use disorder, psychosis, or mania * contraindication for fmri as determined by cmrr safety screening standards * history of neurological disorder/injury (e.g., stroke; head injury with \> 10 minutes loss of consciousness)
comparison of the efficacy and safety of tiropramide and octylonium in the treatment of irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study was to compare the efficacy and safety of tiropramide hcl and octylonium bromide in the treatment of irritable bowel syndrome.


Eligibility criteria:
inclusion criteria: 1. adult patients (aged 20-75 years) 2. patients who had been suffered from ibs as defined by rome iii criteria 3. patients who had abdominal pain at least 2 days/week, during the run-in period of 2 weeks exclusion criteria: 1. patients with known intolerance to tiropramide or octylonium 2. patients with uncontrolled diabetes, uncontrolled hypertension or thyroid dysfunction 3. patients who had the history of cancer \[however, patients with cancer other than gastrointerstinal cancer, who have not recurr within 5 years after treatment were possible for enrollment\] 4. patients with hepatic or renal dysfunction 5. patients with lactose intorelance
block and periarticular injection study

Conditions: Pain, Postoperative

Summary: the purpose of the study is to compare two types of perioperative analgesic modalities, adductor canal block plus interspace between popliteal artery and capsule of the knee (ipack) block and periarticular injection versus periarticular injection alone, to determine their relative efficacies with regard to pain relief and functional outcomes in the early postoperative period following primary total knee arthroplasty.

the widespread adoption of multimodal analgesia in contemporary total knee arthroplasty (tka) has led to improvements in perioperative pain control, expedited recovery times, and shorter hospital stays1-3. periarticular injections (pais), adductor canal blocks (acbs), and interspace between popliteal artery and capsule of the knee (ipack) blocks are commonly utilized as part of contemporary multimodal analgesia protocols, but their relative efficacies in improving early recovery after tka has yet to be definitively elucidated4. there are a few known potential drawbacks of acbs and ipacks including surgical delay due to administration timing, increased costs, and small risks associated with a regional block. both regional anesthesia and pai have been found to be effective alone in improving pain and opioid consumption, but there is limited data on whether there is an additive benefit of providing both treatments for patients undergoing primary tka. therefore, the purpose of our study is to compare the efficacy of regional anesthesia and pai vs. pai alone for pain management and functional recovery in the early postoperative period following tka. design prospective randomized trial treatment groups all acbs will be administered as a single shot preoperatively in the holding area on the day of surgery by the regional anesthesia team and pais will be administered intraoperatively by the treating orthopaedic surgeon. group 1: regional anesthesia (acb + ipack) and pai group 2: pai alone

Eligibility criteria:
inclusion criteria: * planning to undergo unilateral primary total knee arthroplasty. * 18 and up * willing to sign informed consent * willing to return for all follow-up visits * smartphone or tablet device capable of running the focusmotion platform exclusion criteria: * bmi \> 45 * preexisting functionally limiting neurologic disorders * hepatic or renal insufficiency * history of unprovoked venous thromboembolism * inability to complete baseline functional testing * chronic opioid or gabapentin and pregabalin use (chronic defined as use \>5 days per week prior to the surgical procedure) * allergy or intolerance to trial medications * planned admission to a postoperative rehabilitation facility * planned general anesthesia * receiving workers compensation or disability payments
a comparison of certoparin and unfractionated heparin in the prevention of thromboembolic events in acutely ill medical patients

Conditions: Thromboembolism

Summary: this study is designed to provide efficacy and safety data for certoparin in the prophylaxis of venous thromboembolism in immobilized, acutely ill medical patients.


Eligibility criteria:
inclusion criteria: 1. hospitalized medical patients 70 years of age or older 2. acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances) 3. written informed consent exclusion criteria: 1. immobilization longer than 3 days prior to randomization 2. prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system 3. expected major surgical or invasive procedure within the next 3 weeks after randomization 4. lmwh/heparin administration longer than 48 hours in the 5 days prior to randomization 5. immobilization due to cast or fracture 6. indication for anticoagulatory or thrombolytic therapy 7. acute symptomatic dvt / pe 8. known hypersensitivity to any of the study drugs or drugs with similar chemical structures 9. acute or history of heparin induced thrombocytopenia type ii (hit ii) other protocol-defined inclusion/exclusion criteria may apply

Keywords: venous thromboembolism medical patients heparin low molecular weight heparin deep vein thrombosis certoparin embolism and thrombosis
remote ischaemic conditioning after stroke trial (recast-2)

Conditions: Stroke

Summary: stroke has an enormous impact on both individual and society. novel treatments are required to relieve this burden and remote ischaemic conditioning (ric) is one such approach. ric refers to applying non-lethal ischaemia to an area distant from an organ you are trying to protect (e.g. the brain). pre-clinical animal stroke studies have shown ric to be neuroprotective and help restore functional outcome when compared to control. these outcomes are achieved simply by transiently occluding the blood supply to a limb (e.g. the arm) very soon after the stroke occurs. the mechanisms of protection are unclear but may be due enhancing the body's ability to protect itself from further injury by favorably altering cerebral blood flow or reducing the detrimental effects of oxygen free radicals. ischaemic conditioning (ic) is an intervention already applied during cardiac surgery to protect the heart from damage and it may be effective after an acute myocardial infarction. the investigators therefore plan to conduct a pilot randomised controlled trial assessing the feasibility of applying ric (4 cycles of blood pressure cuff inflation for 5 minutes) in patients within 6 hours of ischaemic stroke. the primary outcome is feasibility of ric. secondary outcomes include tolerability, safety and clinical efficacy. the results will inform the design of future trials of a potential intervention is that is pragmatic, non-invasive and simple to administer.


Eligibility criteria:
inclusion criteria: 1. suspected clinical stroke with 6 hours of onset of neurological symptoms; 2. age \>18; 3. written or witnessed oral consent, or relative/consultee advice. exclusion criteria: 1. pre-morbid dependency mrs\>3; 2. dementia; 3. coma (gcs\< 8); 4. malignancy or significant co-morbidity thought to limit life expectancy to \<6 months; 5. blood sugar \< 3.5 mmol/l; 6. taking part in another clinical trial of an investigational medicinal product (ctimp); 7. pregnancy.

Keywords: remote ischaemic conditioning
veritas collagen matrix cystocele repair study - postmarketing

Conditions: Pelvic Organ Prolapse

Summary: the purpose of this study is to evaluate the veritas collagen matrix in treating female patients with documented occurence of pelvic organ prolapse as evidenced by a cystocele.

surgery for cystocele repair to be performed. native tissue repair to be randomized versus reinforcement with collagen matrix .

Eligibility criteria:
inclusion criteria: * patient is equal or greater than 18 years old * female * meets follow-up evaluation time frame * understands the nature of the procedure and has provided written informed consent * is scheduled to undergo vaginal pelvic reconstructive surgery * has \> 2nd degree midline cystocele exclusion criteria: * presence of severe mucosal ulceration * previous pelvic organ prolapse surgery using an implant that will affect the use of the vcm or affect the outcome of the study * allergy to bovine material * severe mucosal atrophy * shortened vaginal length as determined by investigator * pregnant or intends to become pregnant during study * has a uti * has vault prolapse \< 2nd degree cystocele

Keywords: veritas cystocele prolapse
dilapan-s / dilasoft e-registry in induced abortion

Conditions: Abortion, Induced

Summary: international observational e-registry on the use of osmotic dilators dilapan-s® / dilasoft® for cervical priming prior to induced abortion.

international, multicentre, non-interventional, observational e-registry, post market clinical follow up study to document current clinical use of dilapan-s or dilasoft for cervical priming before induced abortion with regard to the number of dilators used, duration of insertion of dilators in situ and unusual complications consequent of their use.

Eligibility criteria:
inclusion criteria: * intrauterine pregnancy ≥ 6 and ≤ 24 weeks gestation * patients who are capable of giving consent and sign the form * abortion being made in compliance with the abortion act 1967 (for england, wales and scotland) exclusion criteria: * clinical signs of uterine, vaginal or vulvar infection * acute bleeding

Keywords: cervical dilatation
medical marijuana use in hiv+ patients: probability survey

Conditions: HIV Positive

Summary: more scientific information is needed about medical marijuana use among hiv positive patients. there is conflicting information about the use of marijuana, use of medical marijuana, and the associations between them and health status/health risk behaviors/health care utilization. in addition, it is not clear whether patients who participate in prospective clinical studies differ from participants who do not participate; if there are differences between those two groups, then this would limit generalizability of knowledge about these issues. the goal of this project is to describe the use of marijuana among hiv positive patients and its association with health status/health risk behaviors/health care utilization.

participants will answer questions about marijuana, medical marijuana, and other drug use. we will also ask about health and steps participants take to keep healthy. the study will take up to one hour to complete. participants will also be asked to sign a release of information form. this form would allow us to look at medical records at the hiv clinic.

Eligibility criteria:
inclusion criteria: * patients in the hiv clinic * hiv positive exclusion criteria: * lack of english

Keywords: hiv positive
investigation of the diagnostic efficacy of the m-mode ultrasonography in the diagnosis of myofascial pain syndrome

Conditions: Myofascial Pain Syndromes

Summary: myofascial pain syndrome, or mps, is a prevalent musculoskeletal disorder, which is characterised by the presence of muscle pain and tenderness. the inflammation and microtrauma that are the consequence result in adhesions between the fascial layers. it has been reported that these adhesions prevent the fasciae from sliding over each other and contribute to pain.

the rhomboid and trapezius muscles are commonly involved in mps, which often affects the upper extremity. this study hypothesized that muscle sliding decreases in patients with mps. to this end, the investigators measured the amount of fascial sliding of the trapezius muscle in healthy volunteers and patients with mps using m-mode ultrasound and a software-assisted program to investigate the differences and diagnostic value.

Eligibility criteria:
inclusion criteria: * at least one active trigger point * moderate back pain lasting more than 3 months * diagnosis of mps according to travell and simons diagnostic criteria * healthy volunteers exclusion criteria: * cervical disc disease * fibromyalgia * central or peripheral nerve disease * shoulder joint disease * malignancy * rheumatic disease * those who had been treated for mps within 6 months

Keywords: pain ultrasound
congenital heart defects and nirs

Conditions: Heart Defects, Congenital

Summary: congenital heart defects and nirs

brain, kidney and intestinal tissue oxygenation in newborns with congenital heart defects assessed by near-infrared spectroscopy.

Eligibility criteria:
inclusion criteria: investigators included term newborns with critical structural chd (of different types) who required surgical or transcatheter procedure in the first year of life. chd were diagnosed by pediatric cardiologist by clinical examination and echocardiography. exclusion criteria: the exclusion criteria were pulmonary or neurological disease, perinatal asphyxia, acute illness, prematurity and congenital abnormality other than chd.

Keywords: congenital heart defects near-infrared spectroscopy newborn tissue oxygenation
clinical study of partially hydrolysed protein infant formula on trans-epidermal water loss (tewl)

Conditions: Atopic Dermatitis; Skin Condition

Summary: this is a single-centre, prospective, randomized, open-label, controlled trial of 200 infants 42±7 days of age. subjects will be randomized to one of two open label feeding intervention group: * intact cow's milk protein formula group (cmfg) (n = 100) or * partially hydrolysed whey formula group (phfg) (n = 100).

atopic dermatitis (ad) affects 15 - 30% of children. approximately 45% of these cases have an onset within the first 6 months of life and 60% develop within the first year (bieber 2010). besides environmental factors, the aetiology of ad has been found to be associated with genetic variants involved in skin barrier function defect and inflammation, leading to dry skin with increases in susceptibility to environmental exposures (bieber 2008). partially hydrolysed cow's milk (whey) protein infant formula (phf) has been shown to be effective in prevention of ad, both among at-risk and healthy infants (exl, deland et al. 2000, von berg, koletzko et al. 2003, jingrana and dunjina 2015). however, to date there are no published pediatric data to document the relationship between partially hydrolysed protein formulas and skin barrier function, specifically evaluating the effect of phf on trans-epidermal water loss (tewl) among infants. therefore, this study aims to evaluate the effect on skin barrier function as measured by tewl and we hypothesize that infants consuming partially hydrolysed starter formula will have lower tewl when compared infants consuming intact cow's milk protein starter formula.

Eligibility criteria:
inclusion criteria: * infants 42± 7 days of age at enrolment (date of birth = age 0). * infants who have been born full-term gestational birth (≥ 37 completed weeks of gestation) and having a birth weight ≥ 2.5 kg and ≤ 4.5 kg. * parents /caregivers must agree to follow study procedures and recommended skincare routines, such as avoidance of moisturizers or other skincare products on the primary sites of interest. * parent(s) must have already independently elected before enrolment to formula feed and less than 30% of intake will be from breastmilk. exclusion criteria: * known and diagnosed cow's milk protein allergy/intolerance. * infants currently using or have ever used partially hydrolysed protein formulas. * infants who have ever used topical corticosteroids, calcineurin inhibitors and/or any other physician-recommended treatments for skin conditions after birth. * infants who have been introduced to complementary foods.

Keywords: atopic dermatitis development trans-epidermal water loss allergy growth patterns quality of life gut comfort partially hydrolysed whey
lifestyle and glucose lowering medication in t2dm

Conditions: Diabetes Mellitus, Type 2

Summary: this study evaluates the effect of a lifestyle intervention maintenance of glycemic control while reducing glucose lowering drugs in patients with type 2 diabetes mellitus. the intervention group receives an intensive lifestyle intervention including exercise and diet lifestyle modifications. the reference group receives diabetes educational advice. both groups will have their pharmacological treatment regulated across the study. the primary hypothesis is that lifestyle change is sufficient to maintain glycemic control while decreasing the anti-diabetic medication in a sample patients with type 2 diabetes mellitus.

adherence to lifestyle modifications including increased exercise and healthy diet improves glycemic control in patients with type 2 diabetes mellitus. however, few have investigated the combined effects of these lifestyle changes on maintenance of glycemic control while decreasing the usage of anti-diabetic medications. the primary hypothesis is that lifestyle change is equivalent in maintaining glycemic control (hba1c) compared to the standard pharmacological treatment, the u-turn trial also tests the effects on one key secondary outcome (glucose lowering medication) and examines the effects on sleep quality, fatigue sleepiness, sleep pattern, cardio vascular disease risk factors, psychological outcomes, blood pressure and cholesterol lowering medication. the participants (n=120) is randomized into a experimental group (n=80) and a standard care group (n=40). additionally, the effects of the study will be evaluated 24 month post randomization.

Eligibility criteria:
inclusion criteria: * less than three anti-diabetic medications. * diabetes 2 duration of max 10 years * bmi \>25 but \<40 kg/m2, * accept of medical regulation by the uturn endocrinologists only * accept of purchasing a fitness club membership through u-turn collaborator exclusion criteria: * hba1c\> 9% (75 mmol/mol) * insulin usage * presence of one or more of the following micro- and macrovascular complications of t2dm; a.diabetic retinopathy (except mild nonproliferative retinopathy or early proliferative retinopathy) b. macro-albuminuria or nephropathy c. diabetic neuropathy (except mild affected vibratory testing (\<50 volt)) d. arterial insufficiency e. ischemic heart disease * steroid treatment (inhalation) until three months before the medical examination * tsh raised/below the normal range * liver disease (alat/asat thrice normal range) * inability or contraindication to increased levels of physical activity (pedersen bk and saltin b) * evidence of anaemia * lung disease (except mild asthma and mild chronic obstructive pulmonary disease) * heart disease * kidney disease (creatinine above 130 µm or macro albuminuria) * pregnancy

Keywords: lifestyle exercise physical activity diet glycemic control hba1c glucose lowering drugs
bronchoscopic thermal vapor ablation (btva) for lung volume reduction

Conditions: Emphysema; Chronic Obstructive Pulmonary Disease

Summary: to establish and confirm the safety and clinical utility of btva applied unilaterally for lung volume reduction in patients with upper lobe predominate heterogeneous severe emphysema.

all subjects meeting the eligibility criteria and who provide written informed consent will be enrolled. up to 3 segments in either the right or left upper lobe will be treated with a vapor dose of 10 calories per gram of lung tissue (10 cal/g). targeted lobe for treatment will be based on lobar disease severity.

Eligibility criteria:
inclusion criteria: 1. age: \> 40 and ≤ 75 years old 2. diagnosis of heterogeneous emphysema with upper lobe predominance 3. fev1 \< 45% predicted 4. tlc \> 100% predicted 5. rv \> 150% predicted 6. 6-minute walk test \> 140 meters 7. mmrc ≥ 2 (mmrc) 8. non-smoking for 3 months 9. optimized medical management and completed pulmonary rehabilitation exclusion criteria: 1. known α-1-antitrypsin deficiency 2. bmi \ 35 kg / m2 3. history of pneumothorax within previous 18 months 4. history of heart and / or lung transplant, lung volume reduction surgery (lvrs), median sternotomy, bullectomy, and/or lobectomy 5. respiratory infections or recurring copd exacerbations \> 3 hospitalizations in past 12 months or active infection 6. history of the (ef) ≤ 40%; stroke; unstable myocardial ischemia; fev1 \< 15% predicted; dlco \< 20% predicted; pulmonary hypertension; indwelling pacemaker or implantable cardiac defibrillator (icd); pregnancy or breastfeeding

Keywords: emphysema copd lung volume reduction btva