Kornimate/medical-research-clean huggingface dataset:
feasibility, effectiveness, and patient experience of online acceptance and commitment therapy plus exercises for older people with chronic low back pain

Conditions: Chronic Low-back Pain

Summary: no study has investigated the effects of online act on community-dwelling older adults. given that clinical practice guidelines have recommended exercise therapy for treating people with clbp, a combination of act and exercise therapy may yield better clinical outcomes than exercise alone among community-dwelling older adults with clbp. a double-blinded (participants and statistician) pilot randomized controlled trial (rct) will be conducted to evaluate the feasibility and the relative effects of online act plus back exercise training as compared to exercise alone in improving psychological flexibility, physical well-being, and quality of life of community-dwelling older people with clbp at different time points. the clinical outcomes will be measured at baseline, immediately after the 4-week treatment, and at the 3- and 6-month post-treatment follow-ups. further, a qualitative research study will be conducted to understand the experiences of participating in online act and back exercise training in older people with clbp (including identifying facilitators and barriers to participation).

recruitment posters will be displayed in five hong kong community centers. a total of 40 older people with lbp will be recruited and randomized to either a 4-week online act-plus-back-exercise group or a 4-week online spine care education-back-exercise control group. all participants will be screened for eligibility. after providing the informed consent, participants will undergo baseline assessments. then they will be randomized into either group. immediately after the 4-week treatment and at 3- and 6-month post-treatment, participants will be invited to complete another set of questionnaires that are identical to their baseline questionnaires to evaluate the effects of interventions on their pain, physical function, psychological well-being, and quality of life. semi-structured interviews will be conducted to collect the user experience of participants in both groups by purposive sampling. the interviews will be conducted immediately post-treatment and at the 6-month post-treatment follow-up to evaluate the perspectives at different time points.

Eligibility criteria:
inclusion criteria: 1. have non-specific lbp in or near the lumbosacral spine with or without leg pain that lasts for at least 3-months in the last 12 months 2. have sought some medical or healthcare professional treatments for clbp 3. able to read and write at an adequate level of proficiency in chinese 4. mini-mental status examination (mmse) scores 23 or above exclusion criteria: 1. people with malignant pain or lumbar spinal stenosis 2. confirmed dementia 3. severe cognitive impairment 4. serious psychiatric or psychological disorders 5. mini-mental status examination (mmse) scores below 23

Keywords: chronic low-back pain (clbp) acceptance and commitment therapy (act) psychological flexibility online intervention
determining the impact of air pollution on the developing brain

Conditions: Attention Deficit Hyperactivity Disorder; Attention; Executive Functioning; Social Functioning

Summary: * background: recent studies have linked exposure to airborne particulate matter (pm) to neurodevelopmental outcomes but the findings are mixed and mechanisms are unclear. we aim to determine the impact of pm on the developing brain of schoolchildren in poland, a european country characterized by very high levels of air pollution. the investigators aim to determine the impact of pm on the developing brain of schoolchildren in poland, a european country characterized by very high levels of air pollution. * study area: 19 towns in three voivodeships (lesser poland, silesian, opole) in the southern poland. to reduce confounding by urbanicity and at the same time, to achieve sufficient contrasts in pm levels without too high logistic costs, towns were selected by size (big and small) and by pm levels (high, medium and low). * design: case-control study with 800 children recruited over two school years, with two population controls per one adhd case. suspected cases will be recruited in specialized facilities and presumably adhd-free children will be recruited in primary schools. * exposure assessment: poland-wide pm and other air pollutants' grids will be created for the years 2006 to 2021 using statistical models to incorporate land use data, estimates from transport models, satellite observations and air pollution measurements from polish monitoring network. prenatal, early-life, lifelong and concurrent exposures will be calculated. * psychological testing: every child and their parents will complete a series of psychological tests and interviews that will be conducted during their three visits to the recruitment facility. * neuroimaging: each participant will undergo a magnetic resonance imaging (mri) scanning session that will be performed accordingly to the human connectome adolescent brain cognitive development project recommendations. scanning will be performed on a single scanner in krakow.


Eligibility criteria:
inclusion criteria: * attending school in one of the specified towns * age 10-13 years (4th-6th grade) * native polish speaker * normal or above intelligence * standard educational opportunities * normal or corrected to normal visual and auditory acuity * no gross sensory deficit, no gross behavioural problems * no history of neurological disease exclusion criteria: * autism spectrum disorder (asd) * fas * fae * intellectual disability * metabolic disorders * genetic disorders * epilepsy * cerebral palsy * mood disorders * tourette syndrome * other illnesses including pharmacotherapy * apgar score \< 8 * low birth weight (below 2500 g) * preterm birth (below 35th weeks of gestation)
alveolar cleft hard- and soft tissue reconstruction with an autogenous tooth derived particulate graft

Conditions: Cleft Lip and Palate

Summary: the present study aims at clinical and radiographic evaluation of the safety and efficacy of bonmaker atb powder combined with a novel split thickness papilla curtain flap in the treatment of alveolar cleft defects.


Eligibility criteria:
inclusion criteria: * children with alveolar cleft * patient presented at least three deciduous teeth scheduled for extraction. exclusion criteria: * major relevant clinical diseases, * systemic use of steroids, * current or previous intravenous bisphosphonate treatment, * acute infection at the operation site.

Keywords: cleft lip and palate split thickness flap autogenous tooth bone graft
coroflex isar 2000 extended registry (isar2000 extended)

Conditions: Coronary Artery Disease (CAD)

Summary: postmarket surveillance in terms of the safety and efficacy of sirolimus-eluting coroflex isar stent for the treatment of "real world" patients with de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries.

the aim of the study is to assess the safety and efficacy of elective deployment of the sirolimus-eluting coroflex isar stent for the treatment of "real world" de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries of 2.0 mm up to 4.0 mm in diameter and up to 30 mm in length for procedural success and preservation of vessel patency.

Eligibility criteria:
inclusion criteria: * patients suitable for percutaneous coronary intervention with proof of ischemia * at least 18 years of age exclusion criteria: * intolerance to sirolimus and/or probucol * allergy to components of the coating * pregnancy and lactation * complete occlusion of the treatment vessel * severely calcified stenosis * cardiogenic shock * risk of an intraluminal thrombus * haemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy * surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior * severe allergy to contrast media * lesions which are untreatable with ptca or other interventional techniques * patients with an ejection fraction of \< 30 % * vascular reference diameter \< 2.00 mm * treatment of the left stem (first section of the left coronary artery) * indication for a bypass surgery * contraindication for whichever accompanying medication is necessary
effect of vasopressors on spinal anaesthesia induced hypotension

Conditions: Spinal Anesthesia

Summary: 160 pregnant patients will be enrolled in this study. participants will divide in to 4 groups. spinal anaesthesia will perform with 5% marcain heavy 2 ml+20 microgram fentanyl to the all patients. after performed spinal anaesthesia, vasopressor infusion will be started intravenously. epinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for group e. norepinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for group ne and 0.9% saline (group s) was launched immediately after induction of spinal anesthesia. phenylephrine will prepare 100 microg/ml and infusion rate will adjust 30 ml/h for group p. if systolic blood pressure decrease 20% of basal value or below to 100 mmhg, bolus ephedrine will apply intravenously (iv). if heart rate will decrease 60 beat per min or 20% of basal value, atropine will apply iv.

after approved informed consent, 160 pregnant (term) patients with american society of anaesthesiologist (asa) physiological status i-ii will include this prospective, randomized clinical study. for randomisation of participants, computerized randomisation programme will use and they will divide into 4 groups. basal value of systolic blood pressure(sbp) and heart rate (hr) will calculate with mean of the measure of 3 time sbp and hr before spinal anaesthesia. spinal anaesthesia will perform with 5% marcain heavy 2 ml+20 microgram fentanyl at the point of lumbar 3-4 or 4-5 interspinous space to the all patients. after performed spinal anaesthesia, vasopressor infusion will start intravenously. epinephrine, norepinephrine and phenylephrine will use for vasopressor infusion. epinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for group e. norepinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for group ne. phenylephrine will prepare 100 microg/ml and infusion rate will adjust 30 ml/h for group p. salin infusion will launch 30 ml/h for group salin. if systolic blood pressure decrease 20% of basal value or below to 100 mmhg, bolus ephedrine will apply intravenously (iv) for rescue drug. if heart rate will decrease 60 beat per min or 20% of basal value, atropine will apply iv. at the end of the study all collected data will use for statistically analysis.

Eligibility criteria:
inclusion criteria: * asa i-ii physical status * pregnant patients * full term pregnant exclusion criteria: * asa iii-iv physical status * emergency status * heart disease * hypertension * body mass index\>25

Keywords: vasopressor spinal anaesthesia
a study to evaluate real-world brolucizumab effectiveness and safety in japanese patients with neovascular age-related macular degeneration (namd)

Conditions: Neovascular Age-Related Macular Degeneration

Summary: a retrospective, observational, single-arm, non-randomized cohort study of ocular treatment in namd patients in japan who had records of at least 12 months of follow-up after their first brolucizumab intravitreal injection. patients who had records of at least 12 months of visits after the first brolucizumab injection (index date) were identified during the index period and were recruited during the data collection/recruitment period.


Eligibility criteria:
inclusion criteria: 1. diagnosis of namd. 2. patients 50 years of age or older at index. 3. received first injection of brolucizumab during the index period. 4. gave signed or verbal informed consent. exclusion criteria: 1. patients treated for retinal vein occlusion (rvo), diabetic macular edema (dme), myopic choroidal neovascularization (mcnv), and who had diagnoses of diabetes-related macular degeneration within 6 months prior to the index date. 2. any active intraocular or periocular infection or active intraocular inflammation in the study eye at index date. 3. patients who had any contraindication and were not eligible for treatment with brolucizumab according to the label. 4. patients who were treated with more than 3 types of anti-vascular endothelial growth factor (anti-vegf) before the index date (5th line brolucizumab patients or more). 5. patients participating in parallel in an interventional clinical trial. 6. patients participating in post-marketing surveillance with brolucizumab.
study to determine the efficacy and safety of romosozumab in the treatment of postmenopausal women with osteoporosis

Conditions: Postmenopausal Women With Osteoporosis

Summary: the purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.

in this trial, women were randomly assigned in a 1:1 ratio to receive monthly subcutaneous romosozumab or weekly oral alendronate for 12 months. randomization was stratified according to age (\<75 vs. ≥75 years). after completion of the double-blind treatment period, all the participants were to receive open-label weekly oral alendronate until the end of the trial, with blinding to the initial treatment assignment maintained. the primary analysis was performed when clinical fracture events had been confirmed in at least 330 participants and all the participants had completed the month 24 visit. the study was to continue in an event-driven manner until at least 440 participants experienced a nonvertebral fracture or if the superiority of romosozumab was proven for nonvertebral fractures at the primary analysis.

Eligibility criteria:
inclusion criteria: postmenopausal women who meet at least one of the following bone mineral density (bmd) and fracture criteria: * bmd t-score at the total hip or femoral neck of ≤ -2.50 and either: * at least 1 moderate (semiquantitative grade \[sq\]2) or severe (sq3) vertebral fracture or * at least 2 mild (sq1) vertebral fractures or * bmd t-score at the total hip or femoral neck of ≤ -2.00 and either: * at least 2 moderate (sq2) or severe (sq3) vertebral fractures or * a fracture of the proximal femur that occurred within 3 to 24 months prior to randomization. exclusion criteria: * history of metabolic or bone disease (except osteoporosis) * use of agents affecting bone metabolism * vitamin d insufficiency * history of solid organ or bone marrow transplants * hyper- or hypocalcemia * hyper- or hypothyroidism * hyper- or hypoparathyroidism * possible signs of intolerance to alendronate

Keywords: osteoporosis, osteoporosis-postmenopausal, bone diseases-metabolic, bone diseases, musculoskeletal diseases
cereal-based products fortified with legumes and effects on body weight management

Conditions: Overweight and Obesity

Summary: legumes are high nutritional quality foods and constitute a rich source of proteins and dietary fibers which have been associated with appetite regulation and body weight management. the purpose of the study is to investigate the effects of regular consumption of a cereal-based snack fortified with legumes on body weight reduction.

overweight/obese, non-diabetic subjects will participate in the study. subjects will follow a 12-week energy-restricted dietary intervention supplemented with a certain amount of a cereal-based snack fortified with legumes daily. the effects of dietary intervention on body weight reduction will be examined.

Eligibility criteria:
inclusion criteria: * normal exercise and dietary habits * weight stable for at least 3 months before enrollment exclusion criteria: * diabetes * pregnancy * chronic medical illness * use of nutritional supplements * regular intense exercise * alcohol consumption \> 2 drinks/day

Keywords: cereal-based snack fortified with legumes body weight reduction
prospective study of undiagnosed celiac disease

Conditions: Celiac Disease

Summary: direct benefits to the participants, who are diagnosed with celiac disease may be substantial and could include lessening or prevention of gi symptoms, correction of biochemical abnormalities and reduction in risk for malignancies or bone disease which are most common in untreated celiac disease. however, the precise benefit is unknown and the motivation for this proposed study. if these individuals have a positive celiac serology test at the present time there is a high likelihood that they may have celiac disease.


Eligibility criteria:
inclusion criteria: * at least 60 years old * male and female retrospective testing for celiac disease was done on previously stored serum. contacting specific individuals for inclusion into study
efficacy of extracorporeal shockwave therapy on ultrasonographic changes in de quervain tenosynovitis

Conditions: De Quervain Disease

Summary: the current study will be conducted to explore the efficacy of eswt on ultrasonographic changes, pain intensity level, upper limb function and hand grip strength in patients with de quervain tenosynovitis.

de quervain tenosynovitis (dqt) is a painful condition involving the tendons of the abductor pollicis longus (apl) and extensor pollicis brevis (epb). the pathogenesis is generally defined as a stenosing condition of the first dorsal compartment of the wrist, characterized by thickening of the extensor retinaculum of apl and epb, which can cause tendon gliding difficulties and impingement between the tendons and their fibrous sheaths. the prevalence rate of dqt in the general population is 0.5% for males and 1.3% for females, with peak prevalence at the age of 40-60 years. female prevalence is 6 to 10 times higher than that in men. de quervain tenosynovitis is a repetitive strain injury consider postures where the thumb is held in abduction and extension to be predisposing factors. de quervain tenosynovitis incidence increased by virtue of modern life conditions such as excessive computer use and increased use of cellular phones. however, little research has been carried out to determine the therapeutic effects of eswt in dqt, and up till now, there is a gap in literature that explore eswt efficacy on ultrasonographic changes of dqt. so this current study will be conducted to explore the efficacy of eswt on ultrasonographic changes, pain intensity level, upper limb function and hand grip strength in patients with de quervain tenosynovitis. sixty patients from both genders will be involved in this study and will be randomly subdivided into two equal groups in number. first group (a) (experimental group) will receive radial extracorporeal shockwave therapy plus traditional physical therapy program and the second group (b) (control group): this group will receive traditional physical therapy program.

Eligibility criteria:
inclusion criteria: 1. age from 18 to 65 years 2. both genders (males and females). 3. normal bmi ranges between 18.5:24.9 kg/m2. 4. patients will be referred from an orthopedist with diagnosis of dqt. 5. chronic pain more than 2 months. 6. no history of undergoing physiotherapy modalities or corticosterone injection therapies for any reasons during the past month. 7. de quervain tenosynovitis patients will be diagnosed based on the standard criteria, including pain and tenderness in the lateral wrist and a positive result for the finkelstein test. exclusion criteria: 1. history of undergoing physiotherapy modalities or corticosterone injection therapies for any reason during the past month. 2. subjects with other neurological disorders rheumatologic diseases causing wrist pain. 3. pregnancy. 4. history of fracture or surgery on the hand. 5. severe trauma, and coagulation disorders.

Keywords: extracorporeal shockwave therapy :eswt ultrasonography us handgrip strenght de quervain tenosynovitis
migraine and high flow oxygenotherapy at the emergency department (miox)

Conditions: Migraine

Summary: migraine is a common pathology, affecting around 12% of the general population, up to 25% in some cohorts, as well as a significant part of the reasons for emergency room visits. unlike cluster headaches, the use of high-flow oxygen therapy has not yet been validated in patients with migraine. however, several aspects of its pathophysiology, still studied to this day, suggest that the use of normobaric oxygen could have beneficial effects on migraine attacks: tissue hypoxia, cerebrovascular dysfunction with vasodilation, inflammation, etc. in addition, high-flow oxygen therapy has no significant side effects and almost no contraindication (mainly copd and other chronic respiratory failure) its use in the event of a migraine attack would thus allow less recourse to conventional analgesics (with significant side effects for some), a shorter stay in the emergency room, and therefore a benefit in terms of cost and relief for the patient. in this context, the sponsor wish to carry out a multicenter prospective interventional, single-blind randomized placebo-controlled in parallel groups study.

migraine is a common pathology, affecting around 12% of the general population, up to 25% in some cohorts, as well as a significant part of the reasons for emergency room visits. unlike cluster headaches, the use of high-flow oxygen therapy has not yet been validated in patients with migraine. however, several aspects of its pathophysiology, still studied to this day, suggest that the use of normobaric oxygen could have beneficial effects on migraine attacks: tissue hypoxia, cerebrovascular dysfunction with vasodilation, inflammation, etc. in addition, high-flow oxygen therapy has no significant side effects and almost no contraindication (mainly copd and other chronic respiratory failure) its use in the event of a migraine attack would thus allow less recourse to conventional analgesics (with significant side effects for some), a shorter stay in the emergency room, and therefore a benefit in terms of cost and relief for the patient. in this context, the sponsor wish to carry out a multicenter prospective interventional, single-blind randomized placebo-controlled in parallel groups study.

Eligibility criteria:
inclusion criteria: * 18 years old or more * affiliated to a french public health insurance * ed admission for migraine evocative headache, regarding ichd3 criterions * written informed consent exclusion criteria: * copd or other chronic respiratory failure conditions * pregnant or breastfeeding women or women of childbearing potential not using any means of contraception. a pregnancy test will be performed for women of childbearing age. the results will be communicated to the patient by a doctor of her choice. * under legal protection * patients who have received treatment with triptan in the past 2 weeks * patients who have consumed nsaids in the hour before the doctor's examination * state of migraine headache (crippling attack for more than 72 hours)