Kornimate/medical-research-clean huggingface dataset:
task shifting in the care for patients with hand osteoarthritis

Conditions: Osteoarthritis Both Hands

Summary: the main aim in this randomized controlled trial is to improve access to safe and effective care, professional practice and cost-effective utilisation of health care resources by testing if occupational therapist-led care is as effective and safe as rheumatologist-led care for people with hand osteoarthritis.

hand osteoarthritis is one of the most prevalent musculoskeletal conditions in an adult population, and may have large influences on an individual's function, health related quality of life, and participation in the society. in the absence of disease-modifying interventions, occupational therapy, comprising information, hand exercises, assistive devices and orthoses/splints, is considered as core treatment. in norway, people with hand osteoarthritis are increasingly referred to consultation by a rheumatologist in specialist health care. at the same time a shortage of rheumatologists nationwide is stressing the healthcare system's capacity, and rheumatologists time should therefore primarily be allocated to patients in which early diagnosis and medical treatment are essential. the world health organization recommend task-shifting as one method of strengthening and expanding the health workforce. such models rely on other healthcare providers in expanded clinical roles, where physiotherapists, nurses or occupational therapists working in collaboration with physicians and other team members have their own patients for whom they provide health care services. in this randomized controlled trial, we will test if a new model, where patients referred to consultation in specialist health care receive their first consultation by an occupational therapy specialist, is as safe and effective as the traditional model, where they receive their first consultation by a rheumatologist.

Eligibility criteria:
inclusion criteria: * hand osteoarthritis diagnosed by physician in primary care, referred for consultation in specialist health care, and ability to communicate in norwegian. exclusion criteria: * exclusion criteria were cognitive or mental impairment, possible inflammatory rheumatic disease (sr\>40 or crp\>20, or patient confirming having psoriasis during telephone screening).
comparison of ultrasound-guided continuous erector spinae plane block versus thoracic epidural analgesia

Conditions: Post Operative Pain

Summary: there are limited studies comparing these two modalities ( thoracic epidural and erector spine block) for relieving the pain after thoracic surgeries .this study aim to investigate this purpose

the random sequence will be sealed in consecutively numbered opaque envelopes and kept by the study coordinator. participants will be randomly divided into two groups according to the 1:1 ratio of espb group and teb group. a research coordinator is designated to distribute and preserve randomization result. the coordinator will open the envelopes for allocation according to the order of enrolment and prepare the study drug. the participants will be blinded to the allocation. because the needle injection of espb and teb are very close, participants themselves could hardly detect the clinical differences. anaesthesiologists who perform the nerve block and take charge of intraoperative management and surgeons are independent individuals. only the random sequence number rather than the specific nerve block type will be recorded in the electronic anaesthesia information management system .researchers who do not take part in the nerve block and intraoperative management are designated to postoperative follow-up. besides, trained anaesthesiologist who do not perform the block will be designated to evaluate the clinical features of the block objectively

Eligibility criteria:
inclusion criteria: * eligible patients will be from18-70 years old with ( american association of anaesthesiologist) asa physical status i to iii scheduled for elective thoracic surgeries. exclusion criteria: * patients who are: * unable to cooperate. * patients who have allergy to any of the study drugs. * patients who are on opioids. * local infection at the site of injection or systemic infection. * patients with coagulation disorders or on anticoagulation therapy unable to communicate preoperatively due to severe dementia, language barrier, or neuropsychiatric disorder * unable to perform nerve block procedure due to difficult anatomy through ultrasound scan.
the effect of a mind-body exercise program on aspects of attention in individuals with anxiety

Conditions: Anxiety Disorder

Summary: mind-body exercises is a non-pharmacological intervention to mental health and can improve interoceptive capacity. interoceptive is linked to the process of sensory information within the body playing an important role in behavior. consequently, interoceptive can be modulated by mind-body training through sustained attention to breathing signals, certainty of movements, and also related to activation of brain processes. the present study aimed to evaluation the effect of mind-body in interoceptive capacity in individuals with anxiety. an anamnesis will be performed with demographic data, as well as questions about medications and physical and mental health history. after that, subjects will be randomized into an intervention (one session of mind-body exercises) where they will be asked to sit in a comfortable armchair and remain in a comfortable posture with their eyes closed. a meditation will be guided by an audio through headphones. the audio will last 15 minutes with an initial invitation to centering (full attention to the state of the body and the breath, bringing the attention to the present moment), followed by a body scan considering the seven dimensions of interoceptive capacity (noticing, not being distracted, not worrying, attentional regulation, emotional awareness, self-regulation, and trust) and the passive control group (waiting room), after the intervention the same cognitive tests will be reapplied. then, the groups will be switched for a crossover analysis.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of anxiety * must be able to understand procedures exclusion criteria: * clinical diagnosis of alzheimer's disease
the biodistribution and potential diagnostic ability of 18f facbc in patients with head and neck, breast, and prostate cancer

Conditions: Breast Cancer; Head and Neck Cancer; Prostate Cancer

Summary: see where the dye-like material (facbc) goes in your body and how long it stays in your body. see how much of the dye-like material is picked up by your tumor compare the facbc pictures with other pictures (such as fdg pet scan) that were obtained as part of your standard imaging evaluation.


Eligibility criteria:
inclusion criteria: * age ≥ or equal 18 years old * scheduled for treatment at memorial hospital * primary hnscc or primary breast cancer; histological confirmation of diagnosis at memorial hospital * large primary hnscc cancer (loco-regional advanced, ≥ or equal to t2) by ct/mri imaging or clinical exam, without prior treatment, n1-n3 * large primary breast cancer (≥ or equal to t2) by imaging or clinical impression based physical exam; patients with suspicion of axillary nodal disease (n1-2), without prior treatment * established progressive metastatic prostate cancer * this diagnosis may be based upon histologic confirmation of metastatic disease by biopsy of a lesion or clear clinical evidence for metastatic disease (e.g., based on clinical findings, laboratory data and/or imaging findings in ct, mri, or bone scan), as defined by the referring oncologist * progressive disease is defined as clear progression on imaging studies (increase in size and number of lesions on bone scan, ct, or mri) and consecutive rises in psa as used in clinical management by the prostate cancer oncology group at mskcc * fdg pet scan was obtained as part of the clinical work-up, within 4 weeks prior to enrollment. this clinical fdg pet scan should be done at mskcc. * disease can be clearly demonstrated by structural imaging (ct or mri) or bone scan. this may include characteristic bone lesions on bone scan, ct or mri; and/or measurable soft tissue/nodal lesions on ct or mri. * minimum tumor/metastasis size of 1 cm * negative pregnancy test exclusion criteria: * patient cannot tolerate lying still for approximately 60 minute sessions in the pet tomograph. * pregnancy

Keywords: pet scan
therapy study of automated protocolized vs. physician-directed non-protocolized weaning

Conditions: Neoplasms; Musculoskeletal Diseases; Digestive System Diseases; Respiratory Tract Diseases; Cardiovascular Diseases

Summary: the purpose of this study was to determine whether computer-driven protocolized weaning is superior to physician-directed non-protocolized weaning in over-24-hours-ventilated surgical intensive care unit (icu) patients. the main hypothesis was that weaning duration differs between both methods. secondary hypotheses were that reintubation rate, duration of mechanical ventilation, intensive care unit (icu) length of stay and workload for physicians and nurses differ between both methods.

since long-term mechanical ventilation is affiliated with a bunch of complications, weaning affected patients from ventilation as soon as possible is a crucial point. in this context automated computerized systems have become a torchbearer. these systems are expected to expedite the weaning process, reduce the duration of mechanical ventilation and icu length of stay of a given patient in comparison to conventional physician-directed weaning. a multicenter randomized trial by lellouche et al supported these theories, using a computer-driven system to regulate pressure support ventilation (psv). this system is now commercially available as smartcare/ps (draeger medical ag \& co. kg, luebeck, germany). the purpose of the study on hand was to find out whether the results reported before could be repeated in a broad, surgical icu patient group. study design was chosen similar. in addition we investigated the workload for physicians and nurses in both study arms which has not been conducted before.

Eligibility criteria:
inclusion criteria: * mechanical ventilation \> 24 hours * intubation or tracheostomy * informed consent * 35 - 200 kg bodyweight (77,2 - 440,9 lb) * ramsay-score \< 3 * spontaneous breathing at a peep of \< 10 cm h2o * sufficient arterial oxygenation (pao2 \> 55 mmhg or sao2 \> 90%) * haemodynamic stability (\< 5 µg/kg/min dopamine) * body temperature (rectal) max. 39 °c / 102.2 °f * hemoglobin \> 7 g/dl * ph \> 7,2

Keywords: randomized clinical trials intensive care mechanical ventilation ventilator weaning clinical protocols therapy, computer-assisted humans various surgical diseases requiring mechanical ventilation over 24 hours
a study to determine the effect of methotrexate (mtx) dose on clinical outcome and ultrasonographic signs in subjects with moderately to severely active rheumatoid arthritis (ra) treated with adalimumab (musica)

Conditions: Rheumatoid Arthritis

Summary: this study will investigate the efficacy of both low and high doses of methotrexate (mtx) in combination with open-label adalimumab (ada) in patients who have had an inadequate response to high dose of mtx. the study will also evaluate the pharmacokinetics and safety of the two regimens of mtx in combination with ada in participants with rheumatoid arthritis (ra).


Eligibility criteria:
inclusion criteria: * adult subjects with moderately to severely active rheumatoid arthritis * subjects must have a das28(crp) (disease activity score using c-reactive protein) greater than or equal to 3.2 at baseline (there is no minimum crp score required to qualify) * subjects must have at least 5/68 tender joints plus 5/66 swollen joints assessed at screening or baseline * subject must treated with and mtx (methotrexate) dose (oral and/or injectable) of 15 mg or more per week (no upper limit on dose) for at least 12 weeks prior to screening * subject is either biologic-naïve or has only one prior biologic disease-modifying antirheumatic drug (i.e. abatacept, anakinra, certolizumab, etanercept, golimumab, infliximab, or tocilizumab) exclusion criteria: * previous exposure to adalimumab (humira), rituximab (rituxan), natalizumab (tysabri), efalizumab (raptiva) * subject has been treated with intra-articular or parenteral administration of corticosteroids within 4 weeks of screening * subject has diagnosis or history of gout or pseudogout * subject has undergone joint surgery within 12 weeks of screening (at joints to be assessed by ultrasound) * subject has history of chronic arthritis diagnosed before age 16 years

Keywords: rheumatoid arthritis
strength after breast cancer

Conditions: Breast Cancer

Summary: the goal of this study is to explore whether a group exercise program called strength after breast cancer can be delivered in an outpatient physical therapy clinic to improve physical function among women after treatment for breast cancer. the main questions this study aims to answer are: * can the strength after breast cancer program and the associated outcome battery be successfully delivered in an outpatient physical therapy clinic at massachusetts general hospital and do participants find the program practical? * what are the barriers to and facilitators of delivering the group exercise program in a clinical setting and what changes need to be made to the program to improve sustainability and to facilitate implementation at other clinical sites? participants will complete study questionnaires before and after engaging in the group exercise program and they will participate in interviews following participation in the program.

the goal of this single arm feasibility study of the strength after breast cancer (sabc) evidence-based group exercise intervention for women after treatment for breast cancer is to determine if investigators can feasibly deliver the program out of the outpatient physical therapy clinic at massachusetts general hospital waltham. - following a one-on-one physical therapy evaluation, the four-session sabc program provides a group-based but individualized exercise plan and encourages engagement in independent home-based exercises to improve physical function. the sabc program has previously been found to be safe and led to improvements in physical function among women after treatment for breast cancer. therefore, the focus of this study is to explore clinical implementation barriers, facilitators, and necessary program adaptations to enhance sustainability and facilitate implementation at other clinical sites. study procedures include screening for eligibility, in-clinic visits, questionnaires, and a semi-structured interview. participation in this research study is expected to last up to 5 months. it is expected that up to 40 people will take part in this research study. this is an unfunded study.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * diagnosed with stage i-iii breast cancer, having completed primary cancer treatment (e.g., surgery, chemotherapy, radiation therapy); hormonal therapies and adjuvant targeted therapies will be permitted exclusion criteria: * any injury or medical condition that would prohibit being able to safely perform exercise as indicated by the physical activity readiness questionnaire (i.e., atrial fibrillation, chest pain or angina, uncontrolled high blood pressure or hypertension, loss of balance due to dizziness in the past 12 months, or loss of consciousness in the past 12 months). * non-english speaking

Keywords: physical therapy exercise program
clinical efficacy of calcium and sodium phosphosilicate (novamin) in the treatment of mih (molar incisor hypolimineralization) in pediatric patients

Conditions: Molar Incisor Hypomineralization

Summary: the aim of the following study is to evaluate the clinical efficacy of a toothpaste with calcium and sodium phosphosilicate in the treatment of demineralization of the dental enamel of molars and incisors in pediatric patients. patients who agree to participate to the study will use 2 different toothpaste sensodyne repair and protect and parodontax, which will used with split mouth design. the following indices will be measured: bewe, bleeding index, gingival index, plaque index, dental sensitivity test- schiff, pain intensity index- vas and ppd.

informed consent will be signed by the parents of the patients underage and will be asked the approval for the attendance of the study. to the parents of pediatric patients will be given for free the 2 toothpastes and will be explain the correct procedures for home oral care. the method used in the study is "split-mouth" design, in which contralateral teeth with mih will used for control group. for the study the patients must have at least two demineralizations present on contralateral permanent molars or incisors. the toothpaste used for the study consist in 2 different types: sensodyne repair\&protect (used for the trial group) and parodontax complete protection (used for the control group). the 2 toothpastes will be applied once a day, before going to sleep after normal oral hygiene, for at least two minutes for 28 days after each meeting. the products must be used in minimal quantities, in pea-size doses, applying it on the tooth with the finger while performing a massage, under the supervision of the parents and then rinsing. at each meeting will be taken all the indices and the timing is: t0- study begin, t1- after 1 month, t2-after 3 months, t3- after 6 months, t4- after 9 months, t5- after 12 months.

Eligibility criteria:
inclusion criteria: * presence of at least 2 demineralizations of the dental enamel of molars and incisors (molar incisor hypomineralization-mih) on contralateral permanent teeth * patients with mild or moderate mih * good general health (absence of particular systemic pathologies) exclusion criteria: * patients undergoing orthodontic therapy * patients taking drugs * patients with severe mih (tooth surface with defect \&gt; 2/3, post-eruptive enamel breakage)
a study looking at the use of biomarkers to provide early indication of acute kidney injury in patients with sepsis (limiting aki progression in sepsis)

Conditions: Sepsis; Acute Kidney Injury; Septic Shock

Summary: biomarkers that provide an early indicator of kidney stress could be useful in clinical practice to detect silent episodes of acute kidney injury (aki) or for early identification of subjects at risk of aki. two urinary biomarkers have been identified as early indicators of aki. the nephrocheck® test is a commercially available test that uses these biomarkers, and this study assesses the use of these in reducing negative clinical outcomes for patients with sepsis-associated aki. the study will enroll subjects diagnosed with sepsis, including septic shock, who will be randomly assigned to either receive nephrocheck®-guided kidney-sparing and fast-tracking interventions; or to receive current standard of care assessment and treatment. note: participants are no longer being recruited to this study.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of sepsis or septic shock. * admission to the icu or planned admission to the icu with an expected stay of 72 hours or more after enrollment in the same hospital. * expected to have indwelling urinary catheter placed and kept until at least 48 hours after enrollment. * written informed consent. exclusion criteria: * women with known pregnancy, prisoners or institutionalized individuals. * previous renal transplant. * stage 2 or 3 acute kidney injury (aki) at screening. * receiving dialysis (either acute or chronic), or in imminent need of dialysis at enrollment. * estimated glomerular filtration rate (egfr) \< 45 ml/min/1.73 m2. * known end stage renal disease (esrd) or history of active nephrotic syndrome within the last 3 months. * known stage 2-3 aki within last 2 weeks. * terminally ill (defined as expectation of death within 6 months), has a do not resuscitate order that would restrict protocol-required procedures, or is being admitted only for palliative care. * history of solid organ transplant and receiving calcineurin inhibitors. * documented serious allergy (i.e. anaphylaxis) to vancomycin, aminoglycosides, penicillins, or cephalosporins (intravenous or oral). * known current serum total bilirubin \> 4mg/dl. * subjects already included in an observational study can be co-enrolled in lapis. subjects already included in an interventional study may be enrolled with pre-approval of the sponsor according to the following rules: 1. co-enrollment in lapis will not be allowed with investigational drug and device studies; 2. studies may be allowed if aki or kidney function is not an endpoint with pre-approval of the lapis sponsor; 3. co-enrollment in lapis will not be allowed if co-enrollment is an exclusion criterion in the other study. * subjects with laboratory confirmed covid-19 infection as the primary reason for hospital admission. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: sepsis acute kidney injury kidney damage septic shock biomarkers
health care workers cohort study in the eucare project (eucare-hcw)

Conditions: COVID-19

Summary: the wp3 healthcare workers cohort in eucare is an observational multicentre study including collection of retrospective (historical) and prospective data and sample collection from health care workers with either a vaccination or a confirmed sars-cov-2 infection. samples from hcw are sent to central laboratories for wp2 study were the impact of different variants in humoral and cellular immunity is to be analysed by biostatistical methods and with artificial intelligence in wp5. this analysis will focus on the impact on vaccine escape of viral variants / viral sequences as well as on any escape from any combination of natural and vaccine induced immunity. eight countries will participate (portugal, italy, germany, lithuania, georgia, russia, vietnam and mexico).

background: protection from sars-cov-2 infection is known to occur soon after vaccination or natural disease, fading over time. although protection from serious illness does occur, protection from infection is insufficient and the impact of each variant and of each vaccine or vaccine schedule is a matter of continuous study. recruiting participants from countries with different vaccines and vaccine schedules is of upmost importance to analyse these relationships and breakthrough infections. study objectives: the eucare-hcw study contributes with data and samples from hcw to eucare-immunity study that will analyse the ntab and cmi to different sars- cov-2 variants following any combination of natural infection and vaccination. specific objectives include: * to collect data and biological material from covid-19 healthcare workers in 9 clinics from 8 countries and 3 continents. * enrolment of hcw with an immunogenic event, either vaccination or infection. * periodic collection of serum and whole blood every 4 months since enrolment and during 12-24 months (depending on how long immunity persists). * sample preparation, storage and shipment to central eucare laboratories where wp2 study group will analyse natural and artificial immunity to sars-cov-2 variants (eucare-immunity), namely: * analyse the magnitude, breadth and duration of immunity following natural infection and/or vaccination. * define the cross-immunity among the different viral variants. * analyse the immune escape in a comprehensive set of combinations of vaccines and natural infection(s). * to accomplish the above objectives, wp2 will test: * neutralising antibodies * cellular immunity * viral sequences

Eligibility criteria:
inclusion criteria: the study subjects will be selected based on the following inclusion criteria: 1. adult (\>18 years) hcw with mandatory information on their sars-cov-2 infection and vaccination status. 2. for those with a history of sars-cov-2 infection, diagnosis obtained by detection of sars-cov-2 rna 3. having a signed informed consent when required by ethical approval exclusion criteria: none