Kornimate/medical-research-clean huggingface dataset:
randomised controlled trial of method of levels cognitive therapy

Conditions: Mental Health Wellness 1; Depression; Anxiety

Summary: the purpose of this study is to determine whether method of levels cognitive therapy is an effective intervention for treating clients with a range of presenting problems in primary care by comparing it with a waiting list control condition.


Eligibility criteria:
inclusion criteria: * anyone presenting to primary care services with mild to moderate mental health problems with capacity to provide informed consent and does not meet exclusion criteria. exclusion criteria: * has been accepted into secondary care services. * aged under 16 years. * have an organic basis for their mental health problems. that is, mental health problems that are primarily caused by an identifiable brain malfunction such as thyroid problems or brain injury. * unable to provide informed consent. * is not able to speak, read, write or understand written and verbal english. * individuals who will be unable to understand and/or answer therapist questions due to learning disabilities, brain injury or similar neurological difficulties. * cannot attend sessions at the appropriate clinic.

Keywords: primary health care mental health cognitive therapy
predicting outcomes of distal radius fractures: a surgeon survey

Conditions: Distal Radius Fractures; Survey; Distal Radius Fracture

Summary: the goal of this surgeon survey is to find out if orthopedic and trauma surgeons can predict outcomes in older adults with distal radius fractures. the main questions it aims to answer are: * can orthopedic and trauma surgeons effectively predict which treatment would benefit a patient the most in terms of good outcome versus poor outcome (based on δ prwe) following casting or surgical treatment for displaced intra-articular distal radius fractures? * what are the perspectives of trauma surgeons and orthopedic surgeons on current literature? * what factors direct trauma surgeons and orthopedic surgeons to surgery?


Eligibility criteria:
inclusion criteria: * dutch orthopedic and trauma surgeons * residents * experience with at least five surgeries of distal radius fractures in the past 3 years exclusion criteria: * no experience with distal radius fractures

Keywords: distal radius fracture surgeon survey surgeon survey predicting outcomes preferences
hospital readmission after hipr fracture. impact of a territorial fracture liason service

Conditions: Hip Fractures

Summary: the international osteoporosis foundation (iof) and the american society for bone research and mineral metabolism recommend the creation and implementation of fracture coordination services (fls) as the most efficient way to address the problem. fls has emerged as a new clinical approach that uses coordinated, multidisciplinary care to improve post-fracture outcomes and reduce recurrent fractures. it is a multidisciplinary and protocolized care model that must guarantee: 1. identify fragility fractures and people at risk for a fracture 2. fracture risk assessment 3. indication for treatment or referral 4. improvement in therapeutic compliance 5. reduce the risk of falls it is known that patients who have undergone a fls model (vs no fls), have lower mortality, lower risk of fracture, with a reduction of 35% and 56%, respectively, during two years of follow-up. one of the most important objectives of the fls is the proper recognition and treatment of osteoporosis (op) in patients with fragility fractures. a major problem is the lack of adherence to treatment for op, and inclusion in an fls program increases the prescription of bisphosphonates from 17.9% to 76%. in addition, a specific follow-up program means that 73% of patients followed by fls continue to undergo anti-resorptive treatment after 2 years of having suffered a femur fracture.

hypothesis after a femur fracture due to fragility, upon discharge from surgery at the hospital de la santa creu i sant pau, including patients in a regional fls program will make it possible to complete the study of the patient with fracture, improve adherence to treatment of op (secondary prevention), and obtain better functional recovery.

Eligibility criteria:
inclusion criteria: * all hip fractures older than 65 years exclusion criteria: * politraumatic fractures * metastasic fractures
effect of treatment on activity and muscle function in pediatric patients with scoliosis

Conditions: Scoliosis

Summary: this study will explore the relationship between skeletal muscle and physical activity in scoliosis patients to provide insight into both the etiology of scoliosis and potential ways to mitigate the potential harms of treatment.

the aims include first, to quantify the posture and physical activity of patients in the community before and after scoliosis treatment and compare to age-matched controls. patients undergoing bracing or surgery for scoliosis will wear novel low-profile electronic monitors for 4 days prior to and at one year after initiation of treatment. accelerometer data from the 4 activity monitors are combined for a comprehensive profile of daily activity, above and beyond that of a typical pedometer. analysis will show a participant's % active time vs. static, % time sitting vs. lying down vs. standing vs. walking, total number of steps taken per day, and cadence of walking during each activity bout. the amount of total daily time spent lying, sitting, standing, walking and running will be quantified using specialized processing algorithms developed at mayo clinic. results will be compared to a group of age- and bmi-matched control patients with healed forearm fractures. second, to determine changes in the mechanical properties of the paraspinal skeletal musculature (muscles along the spine) in scoliosis patient before and after treatment with brace or spinal surgery. shear wave elastography (swue) is a technique that uses ultrasound, a non-invasive imaging technique, to detect mechanical properties of tissues. using swue, the stiffness in the paraspinal muscles will be obtained by acquiring shear modulus measurements, reported in kilo pascal (kpa) units. 10 measurements will be obtained for each muscle and a region of interest (roi) will be placed in the displayed elastogram or color map from each measurement to obtain a "kpa" value. a mean shear modulus or stiffness will be obtained by averaging all 10 results. the measurements from each roi are derived using software built in the ultrasound equipment. the change in paraspinal skeletal muscle stiffness will be assessed and compared to normal controls to determine characteristics of spinal musculature in scoliosis patients and the impact of treatment with bracing or surgery.

Eligibility criteria:
inclusion criteria: * males and females between 9 to16 years of age * scoliosis/surgery group; has severe scoliosis curves requiring posterior spinal fusion surgery * scoliosis/brace group; has scoliosis curves requiring brace treatment for at least the next year * the control group will be aged matched participants who have healed forearm fractures and will be matched to case patients by age, gender, and body mass index (bmi). these children will be considered normal subjects for both the accelerometers and the shear wave elastography (swue) exclusion criteria: - patients with underlying muscle conditions or neuromuscular scoliosis
safety and efficacy of 21 gy, 23 gy and 25 gy for high dose rate (hdr) prostate brachytherapy

Conditions: Prostate Cancer; Prostate Neoplasm

Summary: the purpose of this research study is to learn more about the outcomes and early and late side effects of treating early stage prostate cancer with high dose rate brachytherapy.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of early stage prostate cancer. * must be considered either low-risk (t1-t2a, gleason ≤ 6, psa \< 10 ng/ml) or favorable intermediate-risk (gleason 3 +4 = 7, percentage of positive biopsy cores \< 50%, no more than one nccn intermediate risk factor). * prior androgen deprivation therapy is allowed and may have been initiated up to 6 months prior to the date of the hdr implant. the complete duration of androgen deprivation therapy can range from 4 months to 36 months provided it has been initiated no more than 6 months prior to the date of the hdr implant. * at least 18 years of age. * ecog performance status ≤ 2 * able to understand and willing to sign an irb approved written informed consent document (or that of legally authorized representative, if applicable). exclusion criteria: * prior radiation therapy to the prostate or lower pelvis encompassing the prostate. * a history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only. * currently receiving any other investigational agents. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. * unable to undergo general, spinal or local anesthesia. * prior turp with a sufficiently large defect that would compromise the integrity of the implant per clinician's assessment.
a study of bms-986490 with or without bevacizumab in advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a study of bms-986490 as a monotherapy and in combination with bevacizumab in participants with select advanced solid tumors known to express ceacam5.


Eligibility criteria:
inclusion criteria: * documented histologically or cytologically confirmed, advanced, unresectable/metastatic solid tumor measurable by recist v1.1. * crc: part 1a, part 2a-crc, part 1b, and part 2b:. i) locally advanced/metastatic, recurrent, or unresectable crc with adenocarcinoma histology and whose disease has progressed after systemic cancer therapy in the metastatic or adjuvant setting including 5-fu, irinotecan, and/or oxaliplatin (if available and not contraindicated). * nsclc: part 2a-nsclc/gc, 3l+ nsclc:. i) histologically confirmed nsclc meeting stage criteria for stage iiib, stage iv, or recurrent disease. ii) progressed on at least 2 prior lines of therapy, iii) participants must have received and progressed on or after anti-pd-(l)1 therapy, if available. - gc: part 2a-nsclc/gc, 2l+ gc:. i) participants must have received and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting (or have progressed within 6 months of adjuvant therapy). ii) ecog performance status of 0 or 1. exclusion criteria: * history of anaphylactic reactions to irinotecan and/or bevacizumab. * previously received therapy targeting ceacam5. * grade ≥ 3 ild/pneumonitis. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: colorectal cancer (crc) non-small cell lung cancer (nsclc) gastric cancer (gc)
impact of hip flexors isokinetic strengthening on gait capacities in subacute stroke patients

Conditions: Stroke; Hemiplegia; Gait

Summary: post-stroke patients often present with gait disorders due to several physical impairments. hip flexor deficit is one of the more prevalent trouble and is associated with gait capacities. this study aims at evaluating the impact of an isokinetic hip flexors strengthening rehabilitation program in the subacute phase after stroke. patients will be randomized to an intervention group (isokinetic rehabilitation) or a control group (conventional rehabilitation) and assessed at the end of the rehabilitation program, at 3 and at 6 months.


Eligibility criteria:
inclusion criteria: * patients suffering from a first ever stroke * at the subacute phase * able to walk at least 10m with or without assistive devices * hip flexors strength on the paretic side \> 2/5 (mrc) exclusion criteria: * uncontrolled epilepsy * contraindications to physical activity (severe arterial hypertension, aortic valvulopathy, severe pad...) * history of muscular or joint disorders on the paretic hip * subject unable to deliver an informed written consent (due to aphasia, cognitive or psychiatric disorders...) * protected persons * pregnancy

Keywords: stroke gait hip flexors paresis hemiplegia
effectiveness of a workplace "sit less and move more" web-based program in spanish office employees (walk@workspain)

Conditions: Sedentary Lifestyle; Workplace; Quality of Life; Intervention Study

Summary: this study assesses the short and mid-term impacts of a workplace web-based intervention (walk@workspain, w@ws) on self-reported occupational sitting time, step counts, activity-related energy expenditure, physical risk factors for chronic disease and efficiency-related outcomes in spanish office employees. half of participants had access to the w@ws website program while the other half was asked to maintain habitual behaviour.

rising numbers of people have to sit for long hours every day especially for work and transport (3401184). this sedentary pattern that has been detrimentally associated with obesity and cardiovascular disease markers (4604082). however, replacing as little as 10 minutes of sedentary time with the same amount of light or moderate physical activity is associated with substantial health benefits (i.e. reduction of the metabolic syndrome) (26635358). because eighty percent of adults in developed countries spend one third of their working day doing sedentary, desk-based tasks (24603203) -representing a high exposure to this established health risk- displacing occupational sitting with physical activity may be a feasible option for improving office employees´ health and therefore public health (26984326). in this context, there is a need to develop and evaluate translational research, based on theoretically-derived strategies, that can be successfully embedded into workplaces (26984326).

Eligibility criteria:
inclusion criteria: * office employees (university administrative and academic staff) with low and moderate physical activity levels (0 to 3,000 met·min·wk-1 according to the international physical activity questionnaire) exclusion criteria: * highly active office employees (\>3,000 met·min·wk-1 according to the international physical activity questionnaire)

Keywords: workplace sedentary behavior physical activity physical risk factors mental well-being presenteeism work productivity activity-related energy expenditures
angiosome perfusion after tibial bypass

Conditions: Peripheral Arterial Disease

Summary: microcirculation should be assessed before and after tibial bypass surgery by intraoperative fluorescence angiography. according to this, the direct and the indirect angiosomes should be compared according to the individual microcirculatory improvement.

only patients at cli stage rutherford iv to vi with the necessity of tibial bypass surgery will be included. macrocirculation is measured by the ankle-brachial index (abi). in order to assess the skin microcirculation intraoperative fluorescence angiography is used (spy elite™, novadaq, canada). the alteration of microcirculation is compared in direct and indirect revascularized angiosomes by calculation of the fluorescence parameters ingress (in) and ingress rate (inr). clinical follow-up investigations will be performed and the wound healing rate is compared between the different revascularization methods.

Eligibility criteria:
inclusion criteria: * patients at cli rutherford stages iv to vi * patients with necessity of tibial bypass surgery exclusion criteria: * allergy against indocyanine green * iodine allergy * contrast allergy * penicillin allergy * allergic diathesis * liver insufficiency * pregnancy * hyperthyreosis * pulmonary arterial hypertension
role of perfusion ct in pancreatic cancer

Conditions: Adenocarcinoma, Pancreas; Neuroendocrine Carcinoma of Pancreas

Summary: the purpose of this study is 1. to determine whether the perfusion parameters in the normal pancreas and the pancreas cancer (adenocarcinoma or neuroendocrine tumor) are different on perfusion ct 2. to determine whether initial perfusion parameters as well as perfusion parameter change in pancreas adenocarcinoma before and after chemotherapy are different between chemotherapy response group (cr, pr according to recist 1.1) and non response group (sd, pd according to recist 1.1).

1. performance of preoperative perfusion ct for preoperative staging is assessed by comparing with operative finding and histologic disease staging 2. estimation of initial or change of pancreas cancer perfusion parameters and whether those can provide cut-off value for predicting response of chemotherapy in patients with pancreas adenocarcinoma

Eligibility criteria:
inclusion criteria: * patients who are older than eighteen years * patients in whom operation and preoperative computed tomography are scheduled for resectable pancreas adenocarcinoma or pancreas neuroendocrine tumor * patients in whom chemotherapy is scheduled for histologically confirmed pancreas adenocarcinoma * patients in whom chemotherapy is planned for highly suspicious pancreas adenocarcinoma on imaging workup * patients who agree with the study and whose informed consent is obtained. exclusion criteria: * patients who are younger than eighteen years old * patients in whom previously radiation therapy was performed and the rtx field includes pancreas * patients with recurred pancreas adenocarcinoma * patient who are pregnant or nursing patients * patients with renal failure (gfr\<30ml/min) * patients with history of malignancy, except malignancy is in complete remission after operation or iodine therapy for at least five years) * patients with hypersensitivity for iodine or contrast media or other causes of contraindication of contrast-media enhanced ct scan * any other condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with the completion of the study.

Keywords: ct pancreas adenocarcinoma recist perfusion
perioperative virtual reality for pediatric anesthesia

Conditions: Anxiety

Summary: the goal of this study is to evaluate the use of immersive audiovisual distraction and virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at ucsf benioff children's hospital. the study plans to employ virtual reality headsets during induction of anesthesia in pediatric patients for elective surgery in a randomized clinical trial.

the goal of this study is to evaluate the use of immersive audiovisual distraction and virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at ucsf benioff children's hospital. the study plans to employ virtual reality headsets during induction of anesthesia in pediatric patients for elective surgery in a randomized clinical trial. we will be enrolling patients age 5-12 years presenting for elective surgery. patients will be randomized to one of two groups: (1) virtual reality headset with routine anesthetic care and (2) routine anesthetic care only.

Eligibility criteria:
inclusion criteria: * patients aged 5-12 years * patients present in preoperative area for induction of general anesthesia for an elective surgery or procedure exclusion criteria: * patients with injuries to the head/face that would prohibit wearing of headsets * patients with loss of consciousness, altered mental status, life-threatening injuries/illness or multi-trauma * patients with open skin, lice, scabies, or other infectious skin conditions on the head/face * patients with a history of or current symptoms of vertigo * patients who are blind * patients with significant developmental or cognitive delays who may not be able to engage with or tolerate the virtual reality environment, as determined by their parent/caregiver * patients on whom the vr headset does not fit appropriately * non-english speaking patients (due to limited availability of non-english study documents and consents)

Keywords: virtual reality pediatric anesthesia
intact-cord stabilisation and physiology-based cord clamping in caesarean sections

Conditions: Cesarean Section; Infant Conditions

Summary: this is a feasibility study with historical control designed to evaluate whether delivery of the placenta prior to umbilical cord clamping at caesarean sections is a feasible, safe and acceptable way of facilitating intact-cord stabilisation of preterm and term newborn infants.

standard procedure when an infant is delivered by caesarean section is to wait to clamp the umbilical cord for approximately one minute, and then transfer the infant to a designated area for assessment and stabilisation. if the infant needs immediate resuscitation, the umbilical cord is cut earlier to expedite transfer to resuscitation equipment and qualified care (including stimulation, clearing airways and respiratory support). it has been suggested in several pilot and clinical studies that keeping the umbilical cord intact during the infant's transition from intra- to extrauterine life may improve outcomes and survival, especially for preterm infants. since length of the umbilical cord is limited, finding ways to avoid cutting the cord while initiating stabilisation and care is warranted. to date, most studies have reported on interventions that involve mobile resuscitation equipment; thus keeping the infant in close proximity to the mother. this may be extra challenging in caesareans sections, especially due to space constraints and maintenance of sterility. the objective of this study to determine whether extra-uterine placental transfusion to facilitate intact-cord stabilisation and physiology-based cord clamping for infants delivered by caesarean section is feasible, safe and acceptable for infants and their mothers, as well as for involved personnel.

Eligibility criteria:
inclusion criteria: * live infants (singletons or dichorionic twins) born in gestational week 32+0 to 42+0 * delivered by cs in regional anaesthesia * immediate care may be planned with involved personnel prior to delivery * informed maternal consent is obtained (parental consent on behalf of the unborn child). exclusion criteria: * twins, triplets * significant congenital malformations * placenta complications with high risk of abnormal maternal blood loss * severe fetal distress requiring cesarean section in general anaesthesia (crash cs) * participation in any other clinical study within the last month * not sufficient time for preparations or collection of maternal/parental consent * mother does not comprehend norwegian or english

Keywords: infant stabilisation intact umbilical cord umbilical cord clamping placental transfusion cesarean section