Kornimate/medical-research-clean huggingface dataset:
sinovuyo caring families project - pilot trial

Conditions: Child Behavior; Parenting; Child Abuse

Summary: this pilot feasibility trial will evaluate the sinovuyo caring families program in a small-scale randomized controlled trial in cape town, south africa (n=60 families). the pilot study will use a mixed-methods approach to intervention evaluation. self-report and observed quantitative data for intervention and control groups will be collected at pre-test and post-test evaluation. primary outcomes will include parent-reports and observations of child behavior problems. in addition, as an exploratory study, this phase will examine initial pre-post intervention effects for potential mediating factors of parenting behavior, parental stress, parental depression, and perceived social support. however, this phase will not test mediation effects due to small sample sizes. quantitative assessments will also collect data on program fidelity, exposure/adherence, participant engagement, and satisfaction. furthermore, qualitative focus groups with intervention participants and group leaders will examine issues of program feasibility, content, deliver, and satisfaction. randomization will be done on an individual level and include a wait-list control group that will receive the intervention 3 months after the post-test evaluation. results from the feasibility pilot study will be shared with intervention partners and advisory groups. if necessary, final program adjustments will be made prior to further testing. results will also be disseminated to community forums, local organizations, government stakeholders, and via academic conferences. research hypotheses: hypothesis 1: children in the intervention group will demonstrate reduced observed and parent-reported child behavior problems in comparison to the control group. hypothesis 2: parents in the intervention group will demonstrate increased observed and self-reported positive parenting outcomes and decreased observed and self-reported harsh and inconsistent parenting outcomes in comparison to the control group. hypothesis 3: parents in the intervention group will demonstrate decreased parental depression and parental stress outcomes and increased perceived social support outcomes in comparison to the control group. hypothesis 4: the sinovuyo caring families program will be implemented with an acceptable degree of program fidelity, exposure/adherence, and participant satisfaction.


Eligibility criteria:
inclusion criteria: * isixhosa-speaking adults above the age of 18 * primary guardians of children aged 3-8 from khayelitsha, cape town * reside in the same household as child for at least 4 nights per week * score 11 or more on eyberg child behavior inventory problem scale exclusion criteria: * severe mental health problems on beck depression inventory * evidence of severe child maltreatment

Keywords: randomized controlled trials as topic child parents
mesenchymal stem cells infusion for agvhd prophylaxis transplantation

Conditions: Graft-versus-host Disease; Relapse

Summary: infusion of mesenchymal stem cell (msc) at day of recovery after bone marrow transplant (bmt) for patients with al, aa and mm for acute graft-versus-host disease (gvhd) prophylaxis and treatment.

infusion of mesenchymal stem cells at day of recovery after bmt for patients with al, aa and mm for acute gvhd prophylaxis and treatment. infusion at dose 1 cells mln/kg at day of white blood cells recovery.

Eligibility criteria:
inclusion criteria: * allogenic bmt from related or unrelated donor exclusion criteria: * severe infection * relapse * admission to icu * refusal of research * patients with graft failure

Keywords: gvhd relapse overall survival
comparison of effectiveness and safety of sublingual immunotherapy in children with allergic rhinitis

Conditions: Allergic Rhinitis

Summary: the purpose of the trial is to compare the efficacy and safety of sublingual seasonal and annual immunotherapy in children with allergic rhinitis allergic to grass pollens.

allergen immunotherapy is currently the only one method of cause treatment of the ige-dependent allergic diseases. sublingual immunotherapy (slit) is the method which allows to give allergens via alternative oral route in patients home. due to the possibility of avoiding injection this therapy allows to have better relationship with patient, and reduce the costs of therapy thanks to reducing the numbers of visits in out-patient clinic.however efficacy and safety of sublingual immunotherapy are still important issues, especially in children. the purpose of trial is to compare the efficacy and safety of sublingual seasonal and annual immunotherapy in children with allergic rhinitis allergic to grass pollens.

Eligibility criteria:
inclusion criteria: * children with seasonal allergic rhinitis, allergic to grass pollens, first diagnosed at least 2 years before inclusion into the study exclusion criteria: * active upper respiratory tract infection within 3 weeks before the study and acute sinus disease requiring antibiotic treatment within 1 month before the study * allergic rhinitis hospitalisation during the 3 months before the first visit. * additional criteria were other clinically significant pulmonary, hematologic, hepatic, gastrointestinal, renal, endocrine, neurologic, cardiovascular, and/or psychiatric diseases or malignancy that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator. * excluded medications were systemic corticosteroids. * patients who were receiving immunotherapy were also excluded.
fibromyalgia syndrome on anthropometric and ultrasonographic measurements in obstructive sleep apnea syndrome

Conditions: Fibromyalgia Syndrome; Obstructive Sleep Apnea Syndrome

Summary: obstructive type sleep apnea syndrome is a clinical condition characterized by apnea, hypopnea and oxygen desaturation due to narrowing of the upper airway during sleep. obesity is considered a major predisposing factor for osas. in addition, various recent studies have reported that various anthropometric measurements such as neck circumference, waist circumference, hip circumference, waist-hip ratio, neck-waist circumference ratio change (increase) in osas patients.

fibromyalgia is a common health problem that is characterized by pain in various parts of the body and is very difficult to diagnose and treat. it affects 2-4% of the population and is more common in women. the presence of osas in fibromyalgia patients is more common than in the normal population. there are also common additional symptoms such as excessive daytime sleepiness and delayed sleep latency. although it has been reported that the presence of osas is more common in fibromyalgia patients, there is no study on the presence of anthropometric measurements, especially neck circumference, that are accepted in osas. the aim of this study is to compare the anthropometric and ultrasonographic measurements of female osas patients with and without fibromyalgia.

Eligibility criteria:
inclusion criteria: * between 18-65 years old * being diagnosed with fibromyalgia and having applied to the sleep disorders outpatient clinic or being followed up with the diagnosis of osas in the sleep disorders outpatient clinic. * agree to participate in the study exclusion criteria: * patients under 18 years of age * male patients * not agreeing to participate in the study * neurological diseases that may cause osas such as stroke, parkinson's disease, multiple sclerosis * rheumatological, oncological and hematological diseases * central type obstructive sleep apnea syndrome * thyroid pathology that affects neck circumference measurement

Keywords: sleep disorder obstructive sleep apnea syndrome fibromyalgia syndrome anthropometric measurement ultrasonographic measurement polysomnography
homeopathic cold medicine for children

Conditions: Upper Respiratory Tract Infection

Summary: the purpose of this study is to determine if a commercially available homeopathic cold remedy for children is effective in providing relief from cold symptoms in children 2-5 years old. it is postulated that children will have relief of symptoms after receiving a dose of the cold remedy


Eligibility criteria:
inclusion criteria: * children 24-59 months old * cold/cough symptoms of \<7 days duration * diagnosed with upper respiratory tract infection by physician or nurse practitioner * parent who speaks and reads english exclusion criteria: * use of chronic medication other than multivitamins * history of asthma * medication other than acetaminophen or ibuprofen * use of homeopathic remedy within preceding 30 days * only 1 participant per family

Keywords: upper respiratory tract infection children homeopathic
adenoidectomy, myringotomy and tubes' insertion vs adenoidectomy and myringotomy alone in children with otitis media with effusion and adenoid hypertrophy

Conditions: Otitis Media With Effusion

Summary: it is not unusual for several children operated for severe adenoid hyperthrophy causing breathing problems to have otitis media with effusion simultaneously. it is unknown whether adenoidectomy, myringotomy and tubes insertion is superior to adenoidectomy and myringotomy alone in terms of otitis media related quality of life and recurrence of otitis media several months after the operation. for this purpose a randomized trial is conducted including children operated for adenoid hyperthrophy and whose otitis media with effusion had caused minimal or no symptoms so far


Eligibility criteria:
inclusion criteria: * children operated for their adenoid hyperthrophy with an adenoid size of 3 (measured in a scale of 1-3 intraoperatively or from lateral neck x-ray) and otitis media with effusion causing an average air-bone gap of greater than 20db. children should be otherwise healthy with an asa score of i and between 3-12 years old of age exclusion criteria: * other health problems especially related with the condition eg cleft palate

Keywords: adenoidectomy, myringotomy, tubes insertion, otitis media, adenoid hyperthophy
long term observational study to collect in a real-world population data on the treatment pattern of secukinumab in adult patients with moderate to severe hidradenitis suppurativa.

Conditions: Hidradenitis Suppurativa

Summary: the purpose of this observational, prospective, non-interventional, multicenter, open-label, single arm study in hidradenitis suppurativa (hs) is to assess the treatment pattern of secukinumab in a flexible dosing regimen and decision influencing factors for flexible dosing in a real-world population over 2 years.

the study will collect data from patients during routine secukinumab treatment and will be representative of the real-world patient population eligible for secukinumab treatment in germany. in order to attain widespread representation of health care practices related to the use of secukinumab in the approved indication of moderate to severe hs, a broad spectrum of dermatology practices and clinics who are treating patients with hs across germany will be included.

Eligibility criteria:
inclusion criteria: patients eligible for inclusion in this study have to fulfill all of the following criteria at enrollment: 1. patients who provide written informed consent to participate in the study 2. male and female patients with ≥18 years of age 3. diagnosis of clinically unequivocal moderate to severe hs 4. patients for whom a therapy with secukinumab is medically indicated 5. documented decision for treatment with marketed secukinumab regardless of this noninterventional study 6. treatment with secukinumab according to the latest version of smpc 7. initial treatment with marketed secukinumab planned for up to 1 week before the baseline visit exclusion criteria: patients fulfilling any of the following criteria at enrollment are not eligible for inclusion in this study. no additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients: 1. patients who have any contraindications, such as a history of or active inflammatory bowel disease (crohn´s disease, ulcerative colitis), and are not eligible for treatment with secukinumab according to the smpc 2. any medical or psychological condition in the treating physician's opinion which may prevent the patient from the study participation 3. simultaneous participation in any investigational trial or simultaneous participation in another novartis-sponsored non-interventional study with secukinumab 4. previous exposure to il-17 inhibitors 5. for biologic-naïve patients, previous exposure to another biologic drug, such as anti-tnf-α inhibitors

Keywords: hidradenitis suppurativa hs secukinumab germany nis
development of a video-based intervention for suicide prevention

Conditions: Suicide; Psychiatric Hospitalization

Summary: the investigators will develop a brief video-based intervention for suicide prevention, called lifeplans. lifeplans will be tested in an initial open trial (n = 10) to examine its feasibility and acceptability. investigators will recruit patients admitted to a psychiatric hospital for suicidal thoughts and behaviors who will receive the intervention for 4 weeks post-discharge. patients will be assessed at hospital baseline, 1 month post-discharge, and 6 months post-discharge.


Eligibility criteria:
inclusion criteria: * current psychiatric hospitalization for suicidal thoughts and behaviors * 18 years or older * ability to speak and read english * plan to continue outpatient treatment * access to means for viewing videos (computer, tablet, smartphone) exclusion criteria: * current psychotic symptoms

Keywords: video intervention treatment development open trial
a study to investigate use patterns and safety in simulated actual over-the-counter (otc) use of rabeprazole sodium for the treatment of heartburn symptoms

Conditions: Frequent Heartburn

Summary: this is a multi-center, open-label, all-comers otc actual use study in pharmacy sites where the principal investigator will be a pharmacist.


Eligibility criteria:
inclusion criteria to be eligible for participation, consumers must: * male or female, 18 years of age or older * select and purchase the study medication for their own use * be able to take part in periodic telephone interviews regarding their use of and experience with the medication * give written informed consent for participation exclusion criteria consumers will be excluded from participation if they meet any of the following criteria: * allergic to rabeprazole * currently have trouble or pain swallowing food * currently have vomiting with blood * currently have bloody or black stool * currently pregnant or breast-feeding * participated in a study regarding a heartburn medication during the last 12 months
promoting respect and ongoing safety through patient-centeredness, engagement, communication and technology

Conditions: Medical Intensive Care Unit (MICU) Patients; Oncology Unit Patients

Summary: the purpose of this project is to refine, implement, and evaluate a multi-component intervention that achieves sustainable and meaningful impact on healthcare quality, safety, and costs while ensuring dignity and respect for adult oncology and intensive care patients and their care partners. the prospect (promoting respect and ongoing safety through patient-centeredness, engagement, communication, and technology) framework will achieve this by enhancing the patient-provider relationship and introducing patient-centered approaches to multi-disciplinary communication and patient education. the prospect framework is based upon a validated structured, team-work training model and novel web-based technology. the overarching goals of this project are to achieve the following: 1. optimize the overall experience of patients (including their family/care partners) by promoting dignity/respect, encouraging engagement, improving care plan concordance, and enhancing satisfaction. 2. minimize preventable harms in two environments: intensive care and acute care oncology units. 3. reduce unnecessary healthcare resource utilization and associated costs.

this overarching project aims are to refine, implement, and evaluate a multi-faceted intervention composed of the patient-satisfactive® model, developed by drs. ronen rozenblum and david bates at brigham and women's hospital, and a web-based patient-centered toolkit (pctk), developed by drs. dykes and dalal, on quality, safety, and cost outcomes in the intensive care and oncology units at brigham and women's hospital. the specific aims of the project are as follows: * aim 1: to refine and implement the patient-satisfactive® model to promote respect, dignity, and satisfaction of patients, care partners and staff on intensive care and oncology units. * aim 2: to refine and implement a web-based, patient-centered toolkit (pctk), comprised of an electronic bedside communication center (ebcc) and a patient-centered microblog, to promote tailored patient and care-partner education, communication, collaboration, and engagement. * aim 3: to evaluate the relative impact of this intervention compared to usual care on patient reported outcome measures, adverse events (harms), post-discharge healthcare utilization, concordance in understanding the care plan, and satisfaction among care team members (patients/care partners, profession providers). * aim 4: to identify the barriers and facilitators of implementing this intervention to support dissemination.

Eligibility criteria:
inclusion criteria: * age \> 18 * any patient admitted or transferred to designated care units * admitted or transferred to a micu or oncology service * on the designated unit for at least 24 hours exclusion criteria: * age \< 18 * any patient admitted or transferred to designated care unit but not on a micu or oncology service
detection of cf-dna in patients with gastrointestinal stromal tumors (gist)

Conditions: Gastrointestinal Stromal Tumors

Summary: activating mutations of the kinases ckit or pdgfra can be detected in 90% of cases by dna sequence analysis of a pathological specimen. these mutated genomic dna fragments are highly specific for the tumor and are released by the tumor into the circulation. allele-specific pcr can be used to specifically amplify and quantify mutated ckit and pdgfr dna fragments. the current trial aims to evaluate whether tumor dna carrying mutations for ckit and pdgfra can be detected and quantified in the plasma of patients with active gist, and whether detection can be correlated with the clinical course of disease either under therapy or in progressive disease irrespective of current therapy.


Eligibility criteria:
inclusion criteria: * signed written informed consent * male or female patients aged \>= 18 years * histologically confirmed gist * known activating mutation of ckit or pdgfra and tissue sample can be provided for central mutation analysis or mutation status unknown and tissue sample can be provided for central mutation analysis at baseline * routinely planned follow-up visits in no longer than three months intervals (+ 14 days) including local standard of care diagnostic imaging (ct, pet- ct, or mri) * at least one gist lesion that can be measured by ct, pet-ct, or mri * planned surgery of one or more disease manifestations or planned tki treatment (such as imatinib or sunitinib) in neoadjuvant or palliative intention or disease progression irrespective of current/planned treatment * life expectancy of at least three months exclusion criteria: * wild type sequence for ckit exon 9, 11, 13, 14, 17, 18 and pdgfra exon 18 * tissue sample can not be provided for central mutation analysis * surgery of primary or progressive lesions already completed and currently no evidence of progressive lesions * patients currently receiving adjuvant tki treatment after surgery and no evidence of progressive lesions * patients currently receiving palliative tki treatment and no evidence of progressive lesions * planned follow-up intervals including ct, pet-ct or mri at more than three months intervals (+ 14 days) * coexisting medical condition or treatment that could interfere with the ability of the patient to comply with planned treatment interventions (surgery or tki treatment) or regular follow-up visits * patients unwilling to or unable to comply with the planned therapeutic intervention (surgery or tki treatment) or to comply with the regular follow-up visits including blood sample collection * pregnancy and lactation * presence of chronic inflammatory diseases, autoimmune diseases, or liver cirrhosis * known hiv and/or hepatitis b or c infection * other malignancies within the past 3 years except for adequately treated carcinoma of the cervix and basal or squamous cell carcinoma of the skin

Keywords: patients with gist treated with standard therapy harboring activating mutations of ckit and pdgfra
effect of pilates exercises on fatigue in post menopausal women

Conditions: Fatigue

Summary: pilates is a system of exercises using special apparatus, designed to improve physical strength, flexibility, and enhance mental awareness. regular exercise of post-menopausal women has benefits of increased cardio-respiratory fitness, increased muscle strength and endurance, reduced body fatigue, improved morale, and increased ability to perform daily tasks with greater force.thus the main objective of regular exercise is prevention of physical deterioration and optimizing functional capacity to improve overall postmenopausal women's quality of life.

fatigue has a negative impact on quality of life of postmenopausal women. fatigue can be an overwhelming experience impacting the physical, emotional and social aspects of them. fatigue can prevent them from carrying out their usual activities of daily living ,menopause-related fatigue can be caused by changing estrogen levels, but it is often compounded by common symptoms, chief symptoms among these are vasomotor symptoms, which are experienced by up to 80% of women and include hot flashes and night sweats that can disrupt sleep , pilates exercise considered a complementary therapy to treat fatigue in postmenopausal women. pilates exercises are a healthy and effective method for improving the functional capacity, flexibility, fatigue, depression and quality of life of post menopause women ,they include stretching and strengthening exercises with controlled and precise movements that have indicated both mental and physical effects on post-menopausal women healththe purpose of physical training using pilates is to improve body functioning based on core strengthening that include rectus abdomens, transverse abdomen, erector spine, diaphragm and pelvic floor muscles. the six basic principles of pilates exercise are centralization, concentration, control, precision, respiration and flow .

Eligibility criteria:
inclusion criteria: . all participants will be sedentary. * all participants' ages will be ranged from 50-55 years. * all participants body mass index will not exceed 30 kg/m2. * all participants will be medically stable. * all participants will be able to ambulate independently. * all participants suffering from fatigue, when assessed with fatigue assessment scale (fas) their scores should be \>22. exclusion criteria: * • post-menopausal women who have uncontrolled hypertension. * post-menopausal women who have thyroid gland disorders. * post-menopausal women who have history of syncope or arrhythmia induced by physical exercise. * postmenopausal women who have any mental, neurological, vestibular, cardiovascular disorders or metabolic disease. * postmenopausal women whose visual or hearing impairment did not allow possibility of intervention. * postmenopausal women who have been received hormonal replacement therapy or any drug known to affect their physical activity. * post-menopausal women who have any other problems that make it impossible to perform physical exercises.

Keywords: fatigue sleep disturbance