Kornimate/medical-research-clean huggingface dataset:
pilot study of the vermont family based approach in primary care pediatrics

Conditions: Psychiatric Disorder

Summary: this pilot randomized controlled trial of the vermont family based approach (vfba) tested the feasibility of the vfba in primary care pediatrics and its effects on children's and parents' emotional and behavioral problems and health-related quality of life. the vfba is a public health framework for evidence-based health promotion, prevention, and treatment that is delivered from the family perspective and emphasizes emotional and behavioral health. the vfba group received the vfba intervention, while the control group received pediatric primary care as usual.

to enhance the health of our communities, we need approaches to healthcare delivery that focus on the entire family, recognize the central role of emotional and behavioral health in relation to all health, use evidence-based health promotion in addition to evidence based treatment of existing problems, and intervene early in children's life. the vfba is a public health framework for evidence-based health promotion, prevention, and treatment that is delivered from the family perspective and emphasizes emotional and behavioral health. the study was a pilot rct of the vfba in a primary care pediatrics clinic. the goals of the study were to test whether the vfba would (1) be feasible in primary care pediatrics and (2) would lead to improved emotional and behavioral health and health-related quality of life or children and parents. families were recruited at the pediatric clinic and randomized to the vfba or control conditions. the vfba group received family-based assessment of emotional and behavioral health and family functioning, family wellness coaching, and a menu of cost-free wellness activities, such as parent and child violin instruction, yoga and mindfulness training, and nutrition counseling. where indicated by results of family-based assessment, families in the vfba group also received family-based, evidence-based psychotherapy and psychiatric care. families in the control group received pediatric primary care, as usual.

Eligibility criteria:
inclusion criteria: * families with a 3 - 15 year-old child who receives his/her primary care at the university of vermont pediatric primary care clinic exclusion criteria: * families with a target child in the legal custody of the state of vermont * families where the parents' proficiency in english is not sufficient to participate in the protocol without an interpreter

Keywords: health promotion prevention mental health quality of life pediatrics wellness preventive medicine preventive psychiatry patient participation health literacy patient activation patient engagement emotional health behavioral health
effectiveness of mckenzie and trochanteric belt with ct therapy to reduce pain and dysfunction of si joint

Conditions: Sacroiliac Joint Dysfunction

Summary: to determine the effectiveness of mckenzie exercises and trochanteric belt with conventional physical therapy to reduce pain and dysfunction of sacroiliac joint (sij) in pregnant women

to findout the effectiveness of exercises in pregnant women

Eligibility criteria:
inclusion criteria: * pregnant patients with sacroiliac joint pain are included and participant patients with age group 18- to 35 * low back pain due to sacroiliac joint who suffer from sever pain during sitting and during positioning change when stand from sitting position are included exclusion criteria: * patients with age group of below 18 years and above 35 years * patients with disease of coagulopathy * systemic infection * skin infection over sacroiliac joint patients with history of allergies to injected medications. * patients with psoriasis * inflammatory bowel disease * peripheral arthritis * women with uti complications are excluded. * women with respiratory issues are also excluded
playgait: a dynamic exoskeleton

Conditions: Cerebral Palsy

Summary: playgait is an investigational dynamic energy storage and return (esr) lower-limb exoskeleton for young children with cerebral palsy (cp), that stores energy while the child is in the stance phase of walking and returns that energy in terminal stance and early swing phase of walking. playgait assists with the passive dynamics of walking through an exotendon (comprised of a spring in series with a cable). the overall objective of this investigational device is to promote correct walking patterns that encourage proper bone alignment, muscle recruitment, and strengthening during walking practice in young children with cp. the study will evaluate children with cp's activity levels in the community with and without playgait. the study will consist of three lab visits and two, 7-day periods at home.


Eligibility criteria:
inclusion criteria: * age 3 - 4 years (at time of informed consent) * hemiplegic cerebral palsy * if child uses an ankle-foot orthosis (afo), parent/caregiver is willing to have the child stop wearing their prescribed afo during data collections (lab sessions and two 7-day periods at home) * ability to walk at least 10 meters without the use of assistive devices or afos * ability to walk at least 1 minute without the use of assistive devices or afos * stiff knee gait - less than normal knee flexion during swing phase * hip flexion passive range of motion contracture less than 20 degrees * gross motor function classification system (gmfcs) levels i-ii * modified ashworth scale (mas) \<=2 for the gastrocnemius soleus, rectus femoris, and hamstrings * family has resources to attend all study sessions (transportation, schedule) * ability to speak and understand in english exclusion criteria: * orthopedic surgery in the last year * foster children or wards of the state * use wheelchair or stroller mobility as their primary method of independent mobility * severe visual impairment such that the visual impairment itself functionally limits mobility * phenol or botox injections to the legs in the last 3 months * uncontrolled seizure disorder, defined as any seizure in the last 3 months that influenced mobility skills and function (seizures which did not affect mobility are acceptable) * lower limb fracture in the last 3 months * planned surgery or changes to movement disorder medication during the study period * inability to understand directions sufficiently to complete the study assessments * cognitive, behavioral, or any other issues that may not allow for effective study participation * unwilling to complete the study protocol

Keywords: pediatric orthosis exoskeleton
pharmacokinetics of alglucosidase alfa in patients with pompe disease

Conditions: Pompe Disease; Glycogen Storage Disease Type II (GSD II)

Summary: * the primary objective of this study was to characterize the pharmacokinetics (pk) of alglucosidase alfa manufactured at the 4000 l scale in participants who had a confirmed diagnosis of pompe disease. * a secondary objective of this study was to evaluate and explore the relationship between anti-recombinant human acid alpha-glucosidase antibody titers and the pk of alglucosidase alfa.

the total study duration per participant was 4 to 8 weeks that consisted of a screening period (from 2 days to 4 weeks), treatment visit (1 day), and a follow up call (greater than or equal to 30 days). two participants enrolled prior to protocol amendment 2 (dated 17 december 2015), which changed the study to single-dose, and were treated for 26 weeks, with a 4-week follow up.

Eligibility criteria:
inclusion criteria: a participant was to meet all of the following criteria to be eligible for this study: * the participant and/or the participant's parent/legal guardian was willing and able to provide signed informed consent. * the participant had a confirmed acid alpha-glucosidase (gaa) enzyme deficiency from skin, blood, or muscle tissue and/or 2 confirmed gaa gene mutations. * infant and toddler pompe disease participants could be included in the study only under condition (minimal body weight) that the trial-related blood loss (including any losses in the maneuver) would not exceed 3 percent (%) of the total blood volume during a period of 4 weeks and would not exceed 1 % at any single time. * the participant, if female and of childbearing potential, must have had a negative pregnancy test (urine beta-human chorionic gonadotropin) at screening. note: all female participants of childbearing potential and sexually mature males must have agreed to use a medically accepted method of contraception throughout the study. * for participants previously treated with alglucosidase alfa the participant had received alglucosidase alfa for at least 6 months. exclusion criteria: a participant who met any of the following criteria was excluded from this study: * the participant was participating in another clinical study using an investigational product. * the participant, in the opinion of the investigator, was unable to adhere to the requirements of the study. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
combined effects of lion's breath technique with chest percussion therapy in pneumonia patients

Conditions: Pneumonia

Summary: this study will be randomized controlled trial with non-probability convenient sampling. sample size will be 90,45 in each group. outcome will be measured by using 6 minute walk test, spirometry (fvc, fev1/fvc and pef), functional independence measure.

the main objective of the study is to determine the effect of lion's breath technique along with chest percussion therapy in pneumonia patients. this study will be randomized controlled trial with non-probability convenient sampling. sample size will be 90,45 in each group. participants included will be adults aged 18 years and above diagnosed with pneumonia. willing to comply with the study protocol. both male and female will be included. participants should be in stable health conditions to participate in the study. patients with severe or life-threatening pneumonia requiring immediate intensive care and patients with physical or cognitive limitations. patients with a history of chronic respiratory conditions such as copd, bronchitis, or asthma. pregnant or breastfeeding women. individuals with musculoskeletal or neurological conditions and patients with contraindications to chest percussion therapy, such as recent surgery or trauma to the chest area will be excluded. group a (lion's breath technique + chest percussion therapy) daily supervised lion's breath technique sessions will be for 20 minutes for 1 week. trained physiotherapists administer chest percussion therapy will be to mobilize secretions and improve lung function. daily session for 30 minutes for 1 week. pre and post data will be gathered. outcome will be measured by using 6 minute walk test, spirometry (fvc, fev1/fvc and pef), functional independence measure.

Eligibility criteria:
inclusion criteria: * patients in the post-acute phase of pneumonia recovery. * adults aged 18 years and above diagnosed with pneumonia. * both male and female will be included. * participants should be in stable health conditions to participate in the study. * willing to comply with the study protocol exclusion criteria: * patients with severe or life-threatening pneumonia requiring immediate intensive care * patients with physical or cognitive limitations * patients with a history of chronic respiratory conditions such as copd, bronchitis, or asthma * pregnant or breastfeeding women * individuals with musculoskeletal or neurological conditions * patients with contraindications to chest percussion therapy, such as recent surgery or trauma to the chest area

Keywords: breathing exercises lion's breath technique pulmonary rehabilitation
empathy and emotional regulation: a multi-national cross-sectional study

Conditions: Empathy; Emotional Regulation; Burnout

Summary: significant levels of psychological disorders and psychological distress among higher education students have been reported worldwide (galdino et al., 2020), given that during these years there is a peak in prevalence of many mental disorders, particularly major depressive disorder (18.5% to 21.2%), generalized anxiety disorder (18.6% to 16.7%) and drug use disorder (45.9% to 59.8%). (auerbach et al., 2018). additionally, compared to other major students, medical school and nursing students experienced higher levels of burnout due to the complex curriculum and pressure for professional performance (ling et al., 2014). altogether, this evidence show that nursing students frequently experience psychological and emotional problems such as academic exhaustion, stress, depression, and anxiety during their four years of completing their degree (hwang \& kim, 2022). to the best of our knowledge, this study is the first of its kind that addresses the issue of burnout and its relation to empathy and emotional regulation among nursing students at the middle east. analyzing burnout syndrome among undergraduate nursing students may provide support for managers to implement prevention and management strategies in relation to the syndrome, in order to ensure health and well-being during the professional training process, as well as providing training for nurses engaged and prepared to provide quality care. thus, this study aims to investigate the burnout syndrome among nursing students and its relation to empathy and emotional regulation.


Eligibility criteria:
inclusion criteria: * undergraduate nursing students from the five full-time levels exclusion criteria: -
dry needling dosage in the treatment of myofascial neck pain

Conditions: Neck Pain

Summary: the purpose of this study are (1) to determine the effectiveness of different dry needling dosages in the treatment of myofascial trigger points in the upper trapezius muscle in patients with myofascial neck pain, (2) to assess postneedling soreness and tenderness and (3) evaluate the influence of psychological factors on the perception of postneedling soreness.


Eligibility criteria:
inclusion criteria: * diagnosis of an active myofascial trigger point. neck pain: superior to 3 cm in vas exclusion criteria: * neck area: fracture, radiculopathy, previous surgery, previous needling treatment in the last 6 months, previous analgesic medication (24 hours), psychiatric disease
low-dose uva1 radiation in cutaneous lupus patients

Conditions: Cutaneous Lupus Erythematosus

Summary: the investigators are conducting an open-label clinical trial determining the effects of uva1 phototherapy on cutaneous lupus (cle) patients. past research on systemic lupus (sle) subjects indicates that this treatment is likely to be effective in treating cutaneous lupus with few side effects. the fact that most cle patients are seen at dermatology clinics also increases the usefulness of this study because there is a large probability that phototherapy treatment will be accessible for many of the patients that stand to benefit from it.

study subjects will receive low dose (20 j/cm2) uva1 phototherapy treatment three times per week for 10 weeks. each treatment will take less than 30 minutes. this period will be followed by an eight-week observation phase to assess longer term effects of the treatment. patients will be assessed for disease activity, and blood studies and photos will be completed prior to, during, and after phototherapy treatment. optional skin biopsies of affected and unaffected skin will be performed at the beginning and end of the active treatment phase.

Eligibility criteria:
inclusion criteria: * you must be 18 years or older with a diagnosis of cutaneous lupus. * you must have at least two active areas of cutaneous lupus. * you will need to come in three days a week for a 10-week period. * you will need to participate in four physician visits and blood draws. exclusion criteria: * you do not have a diagnosis of cutaneous lupus. * you have less than two active areas of cutaneous lupus. * you are unable to come in three days a week for treatment for a 10-week period.
a retrospective study about treatment strategy after first/second line egfr-tki failure

Conditions: Non-Small Cell Lung Cancer

Summary: this is a multi-center retrospective study, designing to access the best treatment strategy in non-small cell lung cancer (nsclc) patients harboring egfr mutant type after first/second line egfr-tki failure. the study end point is progression free survival 2 (pfs2), which is defined as the time period from progression disease 1(pd1) to progression disease 2(pd2). pd1 is defined as the first tumor progression time from taking egfr-tki evaluated by recist 1.1 criterion, and pd2 as the second tumor progression time after egfr-tki failure no matter what second/third line treatment was, pd2 is also evaluated by recist 1.1 criterion.


Eligibility criteria:
inclusion criteria: * patients who was confirmed stage iv (according to international association for the study of lung cancer（iaslc） tnm staging, 2009) non-small cell lung cancer (nsclc) by histology or cytology between year 2009 to 2013, harboring egfr mutant type (19 and/or 21 exon mutation). * appraisable disease, that is there must be at least one lesion with the longest diameter\>10mm according to recist 1.1 criterion (by contrast ct). * patients who take egfr-tki as first/second line therapy. exclusion criteria: * patients who has taken egfr-tki before. * patients who take egfr-tki as third or more line. * patients who take egfr-tki concurrent with chemotherapy or other anti-tumor drug. * the evaluated lesions has treated with radiotherapy before or concurrent with egfr-tki. * patients whose egfr expression is positive by immunochemical and/or egfr amplification is positive by fluorescence in situ hybridization(fish), without mutation detection evidence.

Keywords: non-small cell lung cancer egfr mutant type first/second line egfr-tki
mk0653a (ezetimibe (+) simvastatin) compared to an approved drug (atorvastatin) for the treatment of high cholesterol (0653a-051)(completed)

Conditions: Hypercholesterolemia

Summary: this study is to assess the safety and efficacy of an investigational drug as compared to an approved drug to reduce specific cholesterol levels.

the duration of treatment is 6 weeks.

Eligibility criteria:
inclusion criteria: * elevated cholesterol exclusion criteria: * unstable medical conditions or significant heart problems within 3 months prior to first study visit.
efficacy of rus ga surgical navigation for robot-assisted distal gastrectomy in gastric cancer patients

Conditions: Gastric Cancer

Summary: this investigator-initiated, randomized superiority clinical trial aims to demonstrate the clinical effectiveness of rus ga surgical navigation, an endoscopic imaging treatment planning software, in patients undergoing robotic-assisted distal gastric cancer surgery. the trial will compare the experimental group using rus ga with a control group, aiming to show an 8.7% reduction in total surgery duration. the study will involve global multicenter patient recruitment and evaluate the clinical safety and feasibility of the software, which has been shown to be reliable in previous studies. * investigational medical device: rus ga (endoscopic imaging treatment planning software, e04010.01) * clinical trial duration: 30 months from irb approval -target number of subjects: total of 330 participants

after selecting subjects and obtaining informed consent, randomization will be conducted. robot-assisted gastrectomy will be performed using rus ga or without software. clinical significance will be evaluated through outpatient follow -ups for up to one month after discharge.

Eligibility criteria:
inclusion criteria: 1. individuals diagnosed with gastric cancer and scheduled for robot-assisted gastrectomy. 2. adults aged 20 and above who are capable of independent judgment. 3. individuals capable of undergoing ct imaging according to the prescribed protocol. 4. individuals who, before participating in the clinical trial, undergo an interview in a separate place, understand sufficient explanation of the purpose and content of the trial, and voluntarily sign informed consent form (approved by the institutional review board) exclusion criteria: 1. vulnerable individuals (those lacking decision-making capacity, illiterate individuals, pregnant women, newborns, minors under the age of 20, etc.). 2. patients who cannot undergo ct imaging according to the prescribed protocol before gastric cancer surgery (due to contrast agent allergies, creatinine levels exceeding 1.5 times the normal upper limit, claustrophobia, etc.). 3. individuals whose major gastric or intra-abdominal arterial/venous structures have been altered due to previous gastric or other abdominal surgeries (however, those with a history of intra-abdominal surgery that did not affect the stomach or major blood vessels are eligible). 4. patients with a history of residual gastric cancer from previous surgery. 5. patients who do not consent to participate in the study or withdraw their consent. 6. patients scheduled for simultaneous resection of other organs besides the stomach.
different kinds of acupuncture treatment for knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: knee osteoarthritis (koa) a chronic disease with symptoms of persistent pain or rest pain , joint stiffness, numbness, limitation of activity and even disability, with significant associated costs and effects on individuals' life quality. acupuncture as an approach for the management of chronic pain, is receiving increasing recognition from both the public and professionals. the aim of this study is to indicate the effects of three commonly used acupuncture treatments for koa.

360 subjects with koa recruited from six centers will be randomized to six groups ,and receive four-week acupuncture, electro-acupuncture, moxibustion ,warm-needling ,sham-needle, celebrex treatment. the primary outcomes are visual analogue scale (vas) and womac function score.the secondary outcomes are womac pain score, womac stiffness score,the physical activity scale of the elderly (pase),knee joint swelling measurement and who-bref life quality scale.the follow-up period is six months. this study will be a rigorous,randomized, sham and drug controlled trial focusing on using different kinds of acupuncture treatment for treating koa.

Eligibility criteria:
inclusion criteria: 1. meet the clinical classification criteria for osteoarthritis of the knee, diagnosed by specialist. 2. aged 40-75 years old; 3. history of chronic knee pain for more than 3 months, and complain of knee pain on most days of the past month; 4. kellgren and lawrence grades 1-3; 5. with related knee pain in one or both knees rated \> 4 cm on a 10 cm visual analog scale(vas) (vas:0 to 10) 6. who volunteer to participate and sign the consent form . exclusion criteria: 1. knee osteoarthritis patients with gout, infection, tumor, autoimmune diseases, trauma or other causes of knee pain or knee deformities; 2. patients who have local skin damage, poor skin conditions or coagulant dysfunction and patients who are not suitable for acupuncture; 3. patients who are accompanied with serious medical problems or mental disorders, cognitive dysfunction，disorders of shallow sensation or who cannot cooperate with the treatment; 4. patients who have received acupuncture or needle knife in the past month; 5. other patients who are not suitable for acupuncture treatment.

Keywords: koa acupuncture treatment multi-center rct