Kornimate/medical-research-clean huggingface dataset:
intervening with opioid-dependent mothersmothers and infants

Conditions: Opioid Dependence; Parenting; Infant Development

Summary: this study will assess the efficacy of the modified attachment and biobehavioral catch-up (mabc) intervention, adapted for use with peripartum mothers receiving medication-assisted treatment for opioid use disorder. the investigators expect that mothers who receive the modified attachment and biobehavioral catch-up intervention will show more nurturing and sensitive parenting and more adaptive physiological regulation than parents who receive a control intervention. the investigators expect that infants whose mothers receive the modified attachment and biobehavioral catch-up will show better outcomes in attachment, behavior, and physiological regulation than infants of parents who receive the control intervention.

pregnant mothers will be randomly assigned to receive the modified abc intervention or the control intervention (modified def). hypotheses relate to parent and child outcomes associated with the intervention. hypothesis 1: compared to mothers who receive the control intervention, mothers who receive the mabc intervention will show more nurturing and sensitive parenting, enhanced neural activity during parenting-relevant tasks, and more normative patterns of dna methylation, autonomic nervous system activity, and cortisol production. hypothesis 2: compared to infants of mothers who receive the control intervention, infants of mothers who receive the mabc intervention will show more organized and secure attachment patterns, better behavioral regulation during stressors, more advanced social-emotional development, and more normative patterns of dna methylation, autonomic nervous system activity, and cortisol production. hypothesis 3: enhanced maternal sensitivity will mediate effects of the mabc intervention on improved infant outcomes.

Eligibility criteria:
inclusion criteria: * opioid-dependent pregnant women in third trimester of pregnancy on medication-assisted treatment exclusion criteria: * none
echocardiographic screening of healthy neonates for measuring pulmonary artery pressure

Conditions: Pulmonary Hypertension of Newborn

Summary: the aim of the present prospective study was to evaluate dynamic changes in both pulmonary artery pressure and ductus arteriosus during the first 72 hours after birth.

healthy newborn infants born in alexandria university children's hospital were studied. dynamic changes during the first 72 hours after birth were evaluated.

Eligibility criteria:
inclusion criteria: * gestational age: 37-42 weeks. * birthweight: 2500-4000 g. exclusion criteria: * neonates more than 6 hours of age at time of enrollment. * perinatal asphyxia or hypoxia (1 min apgar scoring\<7 points) * cardiac structural abnormalities detected by echocardiography except patent foramen ovale and patent ductus arteriosus * other clinically detected congenital malformations such as cleft lip and palate, omphalocele, meningocele, etc. * maternal history of gestational hypertension, gestational diabetes, hyperthyroidism, hypothyroidism, and autoimmune disease
body posture, joint mobility, and trunk muscle endurance related to lower back pain in tennis players

Conditions: Low Back Pain

Summary: the aim of this study was to determine the significance of the impact of external factors (self-evaluation of the subjects) and internal factors, including the range of motion in the spine and hip joints, trunk muscle endurance and body posture of tennis players, on the occurrence and severity of low back pain.

the aim of the study was to compare tennis players with and without lower back pain (lbp) and individuals not engaged in asymmetric sports without lbp in terms of spinal flexion, extension, lateral bending range of motion, hip joint flexion, extension, internal and external rotation, modified seat and reach test results, trunk muscle endurance, body posture parameters, and survey information regarding training volume and stretching exercises. identifying significant differences between participants with and without lbp could provide indications for modifying rehabilitation programs for amateur tennis players with lbp or for introducing preventive exercises targeting factors significantly influencing the occurrence of lbp in this population. prior to the study, participants provided written consent and were informed of their right to withdraw from the study at any time.

Eligibility criteria:
inclusion criteria: * provided written consent to participate in the study for study group: * playing tennis at least 3 times per week for the past 2 years * experiencing back pain in the last 6 months that prevented playing tennis for comprarison group i: * playing tennis at least 3 times per week for the past 2 years * no lower back pain (confirmed via survey) in the last 6 months that would have prevented playing tennis for comparison group ii: * no lower back pain (confirmed via survey) * regular physical activity at least 3 times a week * no participation in asymmetrical sports exclusion criteria: * lack of written consent to participate in the study, * history of surgical procedures involving the spine or torso, * severe musculoskeletal pathologies in the medical history, such as previous cancers in the torso area, vertebral fractures, structural scoliosis, * inability to assume the required test positions.

Keywords: low back pain, tennis, rom, muscle endurance, posture
comparison of effectiveness of home based sensory interventions along with standard therapy versus standard therapy alone in autistic children with sensory processing abnormalities

Conditions: Autistic Children With Sensory Processing Abnormalities

Summary: around 69-95% of children with autistic spectrum disorder are known to have sensory processing abnormalities .tackling these problems would help in better quality of life, both for the parents and the children. sensory integration therapy, an individualized clinic based therapy have been shown to have a positive effect on those children with sensory abnormalities. hence the investigators are doing this study , to primarily look into the efficacy and feasibility of home based sensory interventions in autistic children with sensory processing abnormalities.


Eligibility criteria:
inclusion criteria: 1. children between the age group of 3-12years with autistic spectrum disorder as per dsm -v criteria along with cars and those having sensory abnormalities as screened by short sensory profile 2 will be included in the study group 2. parents who agreed for home based sensory intervention therapy with strict adherence to same and to refrain from initiation of any new treatments including medications during study period exclusion criteria: 1. children with epileptic syndromes with language regression(lks) 2. children with features of asd but having underlying structural(ts), neurometabolic or primary epilepsy as etiology 3. children with uncontrolled seizures (seizures in the last 06 months) 4. children whose parents do not give consent for the study 5. children for whom follow up would not be feasible

Keywords: autistic spectrum disorder sensory processing abnormalities sensory interventions occupational therapy
transcatheter aortic valve replacement versu surgical aortix valve replacement for treating elderly patients with severe aortic stenosis and small aortic annuli: a prospective randomized study the viva trial

Conditions: Degenerative Aortic Valve Disease; Aortic Stenosis; Aortic Regurgitation

Summary: to date, no formal, randomized, prospective, head-to-head comparisons of surgical aortic valve replacement (savr) versus transcatheter aortic valve replacement (tavr) have been undertaken in the severe aortic stenosis (as) population with small aortic annuli. objectives of the present study are to compare the hemodynamic performance (incidence of severe ppm and ≥ moderate ar) and clinical outcomes (death, stroke, major or life threatening bleeding) between tavr and savr in patients with severe as and small aortic annuli.

this is a prospective, multicenter, randomized open-label trial including patients with severe as and small aortic annulus (mean aortic annuli diameter ˂23mm and minimal diameter ≤21.5mm, evaluated by 3d-ct or 3d-tee). patients will be randomized in a 1:1 fashion to either tavr or savr. the tavr procedure will be performed with the acurate neo aortic valve, the edwards sapien 3 valve (20, 23 or 26mm) or the corevalve evolut r or evolut pro valve system (23 or 26 mm).new iterations of these valve models may also be included. the savr procedure will be performed using standard techniques, with no limitation in terms of type and size of the valve prosthesis or surgical procedure (e.g. enlargement of the aortic root). for both tavr and savr, the choice of the type and size of valve, access route (for tavr), utilization of additional procedures such as root enlargement will be left at the discretion of heart team of the site treating the patient.

Eligibility criteria:
inclusion criteria: * patients ≥65 years-old diagnosed with severe as (defined as: jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmhg or velocity ratio \ 30 mmhg and aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2 and \>1200 agatston units for women or \>2000 agatston units for men as determined by non-contrast ct). * small aortic annulus defined as a mean aortic annulus diameters ˂23 mm and a minimal aortic annulus diameter of ≤21.5 mm as measured by 3d-computed tomography (ct) and/or 3d-transesophageal echocardiography (tee). exclusion criteria: * prohibitive surgical risk as determined by the heart team * porcelain aorta * aortic root dilatation \>45 mm * coronary artery disease (cad) not treatable by percutaneous coronary intervention (pci) or coronary artery bypass grafting (cabg), or syntax score \>32 (in the absence of prior revascularization) or severe left main disease * non-calcific aortic stenosis * severe mitral regurgitation * moderate-to-severe tricuspid regurgitation requiring surgical repair * prior surgical valve in aortic position
complicated grief among children after a death from cancer or another cause: a longitudinal and prospective study (caps)

Conditions: Grief

Summary: the purpose of this study is to identify risk factors of complicated grief (cg) among children and adolescents who lost a parent to cancer or from an other cause.

although the intensity of the grief and life disruption usually subsides in the months following the loss of a loved one, approximately 7% of bereaved individuals will continue to experience persistent and intense grief-related symptoms associated with marked distress and functional impairment years after the death. while several studies aimed to evaluate risk factors of cg among adults, little is known regarding cg among children and adolescents. therefore, prospective research directly examining the impact of bereavement on post-loss psychiatric symptoms, including cg, post-traumatic-stress disorder (ptsd), depression, attentional and behavioral avoidance among children are needed. improving our understanding of cg risk factors among children will help direct healthcare professionals' clinical attention toward screening and care of this underserved population. furthermore, identifying mechanisms explaining why cancer bereaved children may be at greater risk for persistent psychological distress and cg will inform the development of preventive, early intervention and treatment strategies. participants will be recruited to the child and adolescent grief counseling of the college hospital of toulouse as well as with the team regional resource pediatric palliative care "enfant-do". at 3, 6 and 12 months post-loss, children and their parent will be invited to complete questionnaires assessing peritraumatic dissociative experiences, peritraumatic distress, security attachment, symptoms of cg, symptoms of ptsd and attentional avoidance.

Eligibility criteria:
inclusion criteria: children : * having lost a parent within the last 3 months * signed consent form from the parent * to have health care coverage by the french social security parents : * signed consent form * having lost mother or father of the child within the last 3 months exclusion criteria: children: * both parents are dead * medical disease * ongoing legal procedure regarding the death parents : * decline to take part to the study * mental retardation or schizophrenia * ongoing legal procedure regarding the death

Keywords: complicated grief risk factors cancer children
identifying prognostic variables for persistent ul dysfunctions after breast cancer treatment -reliability and validity

Conditions: Breast Cancer

Summary: breast cancer is the most frequently occurring cancer, assuming that it accounts for 29% of all new cancers in women (european cancer information system). the number of long-term survivors is increasing rapidly due to improving accuracy of the detecting methods, the early diagnosis and advances in cancer treatment. the international consortium for health outcomes measurement initiative described upper limb (ul) function as the health outcome that matters most for breast cancer survivors (bcs). 50% of bcs at 6 months post-radiotherapy suffer from of decreased ul function, i.e. difficulties in performing activities of daily living with the upper limb. patients experiencing ul dysfunctions and other problems are less likely to be physically active. given that physical inactivity is associated with an increased risk of mortality after breast cancer, taking away the barriers to physical activity (e.g. ul dysfunctions) is very important. identifying these factors contributing to chronic ul dysfunction is important in terms of identifying targets for prospective evaluation and specific treatment approaches at specific time points during breast cancer treatment. this study aims to find reliable and valid assessment methods for the prognostic factors and upper limb function itself in a small group of bcs and healthy volunteers.


Eligibility criteria:
inclusion criteria for breast cancer patients * patients scheduled for surgery (mastectomy or breast conserving surgery; in combination with axillary lymph node dissection or sentinel node biopsy) for unilateral primary breast cancer or patients with oligometastatic breast cancer. * patients who receive adjuvant radiotherapy . * patients with a cognitive and language functioning enabling coherent dutch communication between the examiner and the participant * patients who can comply with the protocol at baseline assessment and willing to provide written informed consent inclusion criteria healthy volunteers * healthy women and men(quickdash\<15) age- and gender-matched with a breast cancer patient from the main study * volunteers who can comply with the protocol at baseline assessment and willing to provide written informed consent exclusion criteria breast cancer patients * bcs with widespread distance metastases, previous breast surgery, or planned bilateral surgery * and/or with a diagnosis of a neurological or rheumatological condition, diabetes, * and/or bcs who are not available the entire duration of the study exclusion criteria healthy volunteers * history of breast cancer * patients with a diagnosis of neurological or rheumatological condition, diabetes

Keywords: upper limb dysfunction
acupuncture for treatment of chronic lbp, rct, single blinded

Conditions: Chronic Low Back Pain

Summary: the purpose of this study is to determine whether acupuncture is effective and safe in the treatment of chronic lbp.

the purpose of this study is as follows: 1. pain : vas 2. function : roland disability scale 3. side effect 4. validity

Eligibility criteria:
inclusion criteria: * having chronic, non-specific, lbp of at least 3 months' duration over 20 years old. * back pain must be the chief complaint * having normal neurological test * having signature voluntarily an irb-approved consent form at enrollment exclusion criteria: * potential spinal disease (e.g. a spinal tumor, infection or fracture etc) * other diseases (e.g. bleeding disease, dementia,epilepsy, neurogenic disorder etc) * planned or got lumbar surgery * the prior use of acupuncture within the past 6 months * inflammatory arthritis * the current use of systematic corticosteroids, narcotics, anticoagulants, muscle relaxants * the involvement in legal problem related to lbp * refusal to be randomized

Keywords: acupuncture, rcts, chronic lbp
surgery and radiation therapy with or without chemotherapy in treating patients with mouth cancer

Conditions: Head and Neck Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. it is not yet known if surgery plus radiation therapy is more effective with or without chemotherapy for treating mouth cancer. purpose: randomized phase iii trial to compare the effectiveness of surgery and radiation therapy with or without chemotherapy in treating patients with stage ii, stage iii, or stage iv mouth cancer.

objectives: i. assess the short- and long-term local control rates, disease-free survival, and overall survival following treatment with neoadjuvant cisplatin plus fluorouracil followed by surgery with or without radiotherapy vs surgery alone with or without radiotherapy in patients with previously untreated stage ii-iv squamous cell carcinoma of the oral cavity. ii. assess the prognostic significance of clinical and pathologic responses to neoadjuvant chemotherapy in these patients. iii. compare the short- and long-term toxic effects of these two regimens. outline: this is a randomized, multicenter study. patients are stratified by center and nodal status (n0 vs n1-2 vs n3). patients are randomized to one of two treatment arms. arm i: patients receive cisplatin iv on day 1 and fluorouracil iv continuously on days 1-5. treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. patients with stable disease after 2 courses or progressive disease at any time proceed to surgery. patients undergo resection of the primary tumor site and possible nodal dissection no sooner than 2 weeks after completion of chemotherapy. patients then undergo radiotherapy over 5-6 weeks no later than 8 weeks after surgery. arm ii: patients undergo surgery and radiotherapy as in arm i. patients are followed every 3 months for 1 year, every 6 months for 2 years, and then yearly thereafter. projected accrual: a total of 240 patients will be accrued for this study over 9 years.

Eligibility criteria:
disease characteristics: squamous cell carcinoma of the lower oral cavity eligible for resection t2 (greater than 3 cm), t3, or t4, and n0-3 m0 (uicc staging system) no requirement for postsurgical reconstruction that would impede further radiotherapy patient characteristics: age: 70 and under performance status: who 0 or 1 hematopoietic: wbc at least 3,500/mm3 absolute neutrophil count at least 2,000/mm3 platelet count at least 110,000/mm3 hepatic: not specified renal: creatinine no greater than 1.3 mg/dl creatinine clearance at least 50 mg/ml bun no greater than 50 mg/dl cardiovascular: no cardiopathy other: no significant internal disease no prior malignancy except basal cell carcinoma of the skin no geographic barrier to treatment prior concurrent therapy: no prior therapy

Keywords: stage ii squamous cell carcinoma of the lip and oral cavity stage iii squamous cell carcinoma of the lip and oral cavity stage iv squamous cell carcinoma of the lip and oral cavity
effect of paracetamol, pregabalin and dexamethasone on pain and opioid requirements in patients having a tonsillectomy

Conditions: Pain, Postoperative

Summary: patients scheduled for a tonsillectomy need postoperative pain treatment. some of the most widely used postoperative analgetics (nsaids) sometimes cause rebleeding in the postoperative period, and another often used analgetic, morphine, causes nausea and vomiting. the researchers therefore will investigate new combinations of postoperative analgesics in hopes of improving pain and the need for opioids during the postoperative period.

we will investigate the effect of paracetamol versus paracetamol combined with pregabalin versus paracetamol combined with pregabalin and dexamethasone on pain and morphine requirements in the first 24 hours postoperatively. outcomes include amount of morphine and ketobemidone used, and pain measured on a vas scale. side-effects, e.g., ponv, dizziness and sedation are also measured.

Eligibility criteria:
inclusion criteria: * patients scheduled for benign tonsillectomy * between the ages of 18 and 50 years old * asa 1-2 and a surgical technique without the need for local anaesthetics or electrical scissors exclusion criteria: * malignancy * patients who are unable to cooperate * does not speak danish * has allergy for drugs used in the trial * has abused drugs and/or medicine * epilepsy * diabetes treated with medicine * treatment with systemic steroids 4 weeks prior to the operation * daily use of antacids * daily use of analgesics * use of antidepressives * known kidney disease * pregnancy

Keywords: tonsillectomy pregabalin dexamethasone multimodal postoperative analgesia
the bones project: building healthy bones in children

Conditions: Osteoporosis

Summary: the beat osteoporosis: nourish and exercise skeletons (bones) project is an after-school program that includes weight loading physical activity, nutrition and bone health education, and calcium-rich snacks. the program is designed to improve bone health in early elementary school children.

osteoporosis is a serious public health concern expected to threaten 52 million americans by the year 2010. this debilitating disease comes at an annual cost of $17 billion. by optimizing bone development during the growing years, individuals can lower their risk of osteoporosis by building an adequate reserve of bone. this study will implement and evaluate an after-school program with exercise, education, and diet components designed to improve bone quality and muscle strength in early elementary school children. first and second grade children from 84 after school programs in 33 diverse communities throughout massachusetts and rhode island will be enrolled in the study. after-school programs will be randomized to either the bones project, to the bones project plus a parent/caregiver component, or to a no-intervention control group. the bones curriculum will be implemented 4 days per week over a 20- to 25-week period; each after-school program will implement the program for 2 years. participants will be followed for an additional year, assuming they remain in the after-school program or do not withdraw for some other reason. all parents will be asked to complete a child medical history survey and a parent health survey at baseline, during the 2-year intervention, and at the end of the follow-up year. parents in the bones project plus parent/caregiver component will receive a newsletter and worksheet 5 times per year. participants will be assessed by quantitative ultrasound, height, weight, and body composition measurements, muscular strength, self competence, physical activity level, food knowledge and preference, calcium intake, perceived parental support, and sleep habits.

Eligibility criteria:
inclusion criteria * enrolled in participating after-school program * live in massachusetts or rhode island

Keywords: bone children after-school program osteoporosis calcium physical activity