Kornimate/medical-research-clean huggingface dataset:
covid-19, obesity and lifestyle in children

Conditions: Covid-19; Obesity, Childhood; Lifestyle; Lifestyle, Healthy; Overweight, Childhood; Children, Only; Family

Summary: this study aims to evaluate the impact of the covid-19 pandemic and its measures on lifestyle in dutch children between 4 - 18 years.

the threat of the severe acute respiratory syndrome coronavirus (sars-cov-2, from here onward mentioned as covid-19) and the national measures to restrict transmission of covid-19 in the dutch population have caused a radical change in the daily life of dutch citizens. closing of schools and public locations, even as the public order for social distancing and self-isolation, is affecting the daily structure and lifestyle habits of dutch children greatly. these radical changes in the current situation could yield important information regarding the health behaviour of children and their families. knowledge of these changes and their effects on the health behaviour of these children and their families could influence future interventions and regulations regarding health behaviour. current (preliminary) prevalence figures show that up to 80% of patients infected with covid-19 are overweight or obese, indicating that being overweight or obese could be a potential adverse predisposition in the course of a covid-19 infection. in the light of this (and possible future) pandemic, it is important to investigate the effects of the covid-19 pandemic on the health behaviour i.e. lifestyle of children (aged between 4 and 18 years) and their families and especially the effects on possible weight gain during the covid-19 pandemic. earlier studies demonstrated that in particular children with overweight/obesity gain weight in situations when schools close such as during summer holidays and also during (economic) crisis. it is of importance to investigate the effects of the corona-crisis in particular in these children with a high health risk. this study aims to evaluate the impact of the covid-19 pandemic and its measures on lifestyle in lean children and children with overweight and obesity. it evaluates differences in subgroups, e.a. lean/overweight children, socio-economic status, gender and age. study design is a mixed-methods study. children and/or parents will receive online questionnaires regarding lifestyle during governemantal measures due to the covid-19 pandemic, such as closure of schools and sportclubs. in addition, several children and parents will be interviewed about the changes in lifestyle, and their needs for working on lifestyle, during the pandemic, for in-depth qualitative information.

Eligibility criteria:
inclusion criteria: * children between 4 - 18 years. * living in the netherlands. exclusion criteria: * no signed informed consent by relevant parties (parents of children aged below 12 years, parents and or children aged between 12 and 16 years, or children aged 16 years and older)

Keywords: children lifestyle pandemic covid-19 overweight obesity adolescents
risk for short-term adverse events in older emergency department users

Conditions: Older People; Health Care; Evaluations; Health Impairment

Summary: this study evaluates the association between risk levels (i.e.; low, moderate and high) of emergency room tool (er2) and length of stay in older emergency room tool (er) users admitted to the medical or surgery wards of the jewish general hospital.

the emergency room tool (er2) assessment can be used by emergency department nurses taking care of older emergency department (ed) users on stretcher, and that er2 moderate and high risk levels is associated with long length of stay in emergency department and hospital as well as hospital admissions.

Eligibility criteria:
inclusion criteria: * being 75 years and over * an unplanned emergency department visit and to be on a stretcher. exclusion criteria: -being 74 years and less
effectiveness of music therapy

Conditions: Tuberculosis

Summary: tuberculosis belongs to chronic diseases as a result of the treatment of disease over a long period, admission to negative pressure isolation wards, and restrictions on visitors. during the in-patient admission, patients are vulnerable to social isolation and separation anxiety. if anxiety sustained, patients' quality of life would be affected. thus, it is important to improve patients' experience of anxiety. music has the effectiveness of relaxation, and is helpful to patients' anxious status and physiological responses. this study examined the effectiveness of music therapy on anxiety, depression and physiological responses for patients with tuberculosis.

the experimental study was conducted on a medical center of north taiwan. 66 patients with tuberculosis were included in this study. patients who fit the inclusion criteria were randomly assigned to either experimental or control group. patients in experimental group could choose a piece of cd and listen to music with earphone for 30 minutes. patients in control group just rest for 30 minutes. the procedure was implemented once a day, and sustained for total 5 days.

Eligibility criteria:
inclusion criteria: 1. patient with tb (including patient with drug resistent). 2. age between 18\~65. 3. conscious patient without psychiatric/psychological disorders . 4. patient without visual, audio disorder. 5. patient who is able to understand, speak mandarin and/or taiwanese, and is able to communicate with written or oral. exclusion criteria: 1. medical history of psychiatric/psychologic disorder, medication history of anti-anxiety or anti-depressant which might affect mental status. 2. patient with visual, audio disorder. 3. patient who is not comply with 5 day music therapy.

Keywords: music therapy tuberculosis anxiety physiological response
tolvaptan for advanced or refractory heart failure

Conditions: Heart Failure; Hyponatremia

Summary: this study will clarify the clinical usefulness of tolvaptan therapy in patients with complicated acute decompensated heart failure and hyponatremia (low blood sodium).

despite its demonstrated efficacy and tolerability, tolvaptan remains underutilized for the treatment of acute decompensated heart failure (adhf) in many centers. post-hoc analysis suggests that tolvaptan may provide optimal outcomes in patients with more advanced heart failure (hf) including those with cardiorenal syndrome, marked hyponatremia and severe congestion, or a combination of those conditions. the efficacy of tolvaptan in hf patients with loop diuretic resistance and in those requiring inotropic support remains uncertain. the purpose of this study is to examine the benefit of tolvaptan versus the current standard of care diuretic therapy for patients hospitalized with adhf and evidence of advanced or complex hf with severe hyponatremia. patients with advanced or complex disease are defined as those with suboptimal diuretic response over a 48 hour period.

Eligibility criteria:
inclusion criteria: * hospital admission for adhf with volume overload as evidenced by ≥ 2 of the following: elevated jvp, peripheral edema, ascites, pulmonary rales, congestion on chest x-ray, elevated nt-pro-bnp \> 2000 pg/ml * inadequate clinical response indicated by body weight loss \< 1.0 kg/day over 48 hours despite adequate doses of iv loop diuretic (at least 40 mg furosemide daily) and fluid restriction 2 l/24 hours. * ≥1 of the following over the preceding 48 hours: potential need for inotropic support to improve urine output, and/or renal insufficiency (estimated glomerular filtration rate \<45 ml/min/1.73 m2) * serum sodium ≤134 mmol/l * ≥18 years-old exclusion criteria: * cardiac surgery within 60 days of enrollment * planned cardiac mechanical support or transplant; subjects with previously implanted ventricular assist device (vad) will not be excluded * need for intravenous pressor support for symptomatic hypotension * biventricular pacemaker placement within the last 60 days * hemofiltration or dialysis * known cirrhosis * supine systolic arterial blood pressure less than 85 mmhg * refusal or inability to sign informed consent
clinical evaluation of dcell® acl scaffold for reconstruction of the anterior cruciate ligament

Conditions: Knee Injuries

Summary: the safety and performance of dcell® acl scaffold will be evaluated in 40 patients who have been implanted with the investigational product following a ruptured anterior cruciate ligament (acl) of the knee.

the dcell® acl scaffold is a novel device manufactured from porcine tissue using a patented variation of tissue regenix's platform technology to render the tissue biocompatible and free from cellular material, providing a biological scaffold that is safe for human implantation whilst preserving the biomechanical properties. the device is used to reconstruct traumatic acl tears to help restore normal knee function and therefore prevent further wear of the cartilage and future damage.

Eligibility criteria:
inclusion criteria: * patients with partial or complete tear of the acl and require reconstruction of the acl. * medial collateral ligament (mcl) injury grade 2 or less. * osteoarthritis grade 2 or less on the kellgren lawrence scale. * patients who have given written informed consent; and are willing and able to comply with entire study procedures including rehabilitation protocol. exclusion criteria: * body mass index (bmi) greater than 35 kg/m2. * treatment with any investigational drug or device within two months prior to screening. * patients presenting with abnormal degenerative osteoarthritis of the joint. * previous acl reconstruction on the target knee. * current acl injury on contralateral knee. * patients using anticoagulants within 2 weeks prior to surgery. * patients on current immuno-suppressive or radiation therapy within six months of screening. * patients with diabetes or cardiovascular disease which precludes elective surgery. * patients with documented renal disease or metabolic bone disease.
comparison between cyclophosphamide and combination of methotrexate + calcineurin inhibitor for gvhd prophylaxis

Conditions: Acute Myelogenous Leukemia; Acute Lymphoid Leukemia; Myeloproliferative Disease; Myelodysplastic Syndrome; Chronic Myeloid Leukemia; Chronic Myelomonocytic Leukemia

Summary: the purpose of this study is to determine whether cyclophosphamide post bone marrow transplant increases the rate of patients alive, in remission and without immunosuppression, one year after transplant, when compared with the combination of methotrexate and calcineurin inhibitor

we propose a study in which 150 patients will receive graft versus host disease prophylaxis with cyclophosphamide 50 mg/kg on day +3 and day +4 after bone marrow transplantation, and 150 patients will receive the usual combination of methotrexate and calcineurin inhibitor. the study was designed to last for 4 years. the primary endpoint is the rate of patients alive, in remission and without immunosuppression, one year after transplant. the assignment for each arm of the study will be done through simple randomization.

Eligibility criteria:
inclusion criteria: * man or woman 18 to 60 years of age. * the patient should have a hla matched donor * the patient must need a bone marrow transplant for a malignant disease (acute leukemia, myelodysplastic syndrome, myeloproliferative disease or myelodysplastic/myeloproliferative disease) * patients want to participate in the study, and able to give informed consent. exclusion criteria: * previous auto o allogeneic hematopoietic stem cell transplant * performance status \>2 (ecog). * pregnancy * hiv positive * active infection * cardiac disease with ejection fraction \< 45% * lung disease with fev1, fvc ou dlco \<50% of predicted values. * renal insufficiency with creatinine clearance \< 60 ml/minute. * liver disease with bilirubin levels \> twice the reference value or alt or ast \> three times the normal reference.

Keywords: bone marrow transplantation graft versus host disease acute myelogenous leukemia acute lymphoid leukemia myeloproliferative disease myelodysplastic syndrome chronic myeloid leukemia chronic myelomonocytic leukemia
dismantling the components and dosing of cbt for co-occurring disorders

Conditions: CBT Decoupling; CBT Anxiety Reduction; CBT Combined

Summary: the purpose of this study is to establish a brief cbt intervention that can largely, if not fully eliminate the deleterious effect of common co-occurring anxiety disorders on alcohol use disorder treatment outcomes.


Eligibility criteria:
inclusion criteria: * diagnostic and statistical manual iv diagnosis of panic disorder, generalized anxiety disorder, and/or social anxiety disorder within the past 30 days; * inpatient treatment at lodging plus primarily for alcohol (vs. other drug) dependence * alcohol use in the 30 days preceding the study * ability to provide informed consent * minimum of a sixth grade reading level (deemed necessary to complete study materials); * willingness to provide contact information to confirm study follow-up appointments * lives within proximity to the twin cities (e.g., within about an hour's drive) for the purpose attending follow-up visits exclusion criteria: * lifetime history of psychosis or mania by history * cognitive or physical impairment that precludes study participation * currently and seriously suicidal (i.e., plan and intent)

Keywords: alcohol anxiety
studying genes using cord blood and placenta samples from relatively healthy newborns and samples from younger patients with wilms tumor

Conditions: Kidney Cancer

Summary: rationale: studying samples of blood and tissue from newborns and from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research trial studies cord blood and placenta tissue from newborns, and tumor tissue samples from patients with wilms tumor.

objectives: * what is the frequency of loss of imprinting at birth (in the cord blood and placenta) in a relatively healthy birth cohort? * does deoxyribonucleic acid (dna) methylation levels at imprinting genes have a direct association to the gene expression? outline: archived tumor tissue, cord blood, and placenta samples are analyzed for dna methylation, single nucleotide polymorphism, and gene expression by polymerase chain reaction (pcr), pyrosequencing, and quantitative real-time pcr. information regarding gender and age of the samples are also collected, if possible.

Eligibility criteria:
disease characteristics: * wilms tumor tissue samples from caucasians (fresh or frozen), or dna and ribonucleic acid (rna) samples already isolated from patients registered on children's oncology group wilms tumor protocols * normal/control blood samples from matched individuals * cord blood/ placenta samples from the michels lab epigenetic birth cohort patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: wilms tumor and other childhood kidney tumors
longterm follow-up of subjects with diabetes 2 type treatment with ex vivo gene therapy

Conditions: Diabete Type 2; Mesenchymal Stem Cell

Summary: this is a multicenter, long term safety and efficacy follow up study for with insulin dependent diabetes 2 type who have been treated with ex vivo gene therapy product in ukraine association of biobank bio-sponsored clinical studies. after completing the parent clinical study (2 years),eligible subjects will be followed for an additional 8 years for total 10 years post-drugproduct infusion. no investigation drug product will be administered in the study


Eligibility criteria:
inclusion criteria: * treated with gene therapy of diabetes 2 type in a drug product (mesenchymal stem cell) in a ukraine association of biobank bio-sponsored clinical trial who agree to participate in this study * able to comply with study requirements * provision of written informed consent for this study by subjects or as applicable subject legal/parent guardian exclusion criteria: * there are no exclusion criteria for this study
identification of prognostic and predictive biomarkers in inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Summary: interventional study of a group of patients with an inflammatory bowel disease (ibd; crohn's disease (cd) or ulcerative colitis (uc)) to identify predictive and prognostic biomarkers of natural history and response to biotherapies.

percentage of primary responders who haven't lost response to biotherapies during follow-up (anti-tnf, ustekinumab, vedolizumab). response to treatment will be evaluated using objective criteria for measuring intestinal inflammation: endoscopic remission (endoscopic biopsy and surgical specimens), radiological (mri), and / or biological (crp, fecal calprotectin) . response to therapy rates will be correlated with genomic, epigenomic, and microbiota data stratified by major environmental factors (nutrition, tobacco, physical activity).

Eligibility criteria:
inclusion criteria: * age\>=18 years * patients with an established diagnosis of cd or uc (clinical, biological, radiological, endoscopic or histologic criteria) * patients \>=45 kg * affiliated member of the social security system exclusion criteria: * patients with an undetermined colitis * patients with a non established diagnosis of cd * women of childbearing age without a method of contraception * persons covered by articles l. 1121-5, l. 1121-7 and l1121-8 of the public health code * pregnant women, breastfeeding women -- age \< 18 years * persons under legal protection * person who does not have the capacity to consent * persons under the age of 18 years who are deprived of their liberty by decision of a judicial or administrative authority (articles l. 3212-1 and l. 3213-1).
pilot study of a mobile asthma adherence intervention

Conditions: Asthma

Summary: the purpose of this study is to assess the use of a mobile health intervention to improve adherence to asthma medication among adolescents. the intervention consists of an inhaler sensor strap to monitor asthma inhaler use and a mobile phone application to remind and incentivize patients to use their medication. this study will assess medication use throughout the study in patients who receive a mobile app with reminders and asthma control as measured by the act \[asthma control test\].


Eligibility criteria:
inclusion criteria: * age 11-19 * asthma diagnosis * currently on a daily controller hfa (hydrofluoroalkane) medication for asthma * english-speaking * has a smartphone or access to a smartphone or tablet exclusion criteria: * pregnant * foster care * emancipated minor

Keywords: patient compliance mobile applications
post marketing surveillance to observe safety and efficacy of xyntha® in subjects with hemophilia a

Conditions: Hemophilia A

Summary: this study is to describe the safety and efficacy of xyntha® during the usual care setting.

non probability sample

Eligibility criteria:
inclusion criteria: * patients or legally authorized representatives of pediatric patients agree to provide written informed consent form (data privacy statement). * pediatric and adult patients who have been treated with xyntha for hemophilia a from first approved date by kfda, or who are planned to be newly prescribed xyntha. exclusion criteria: * patients with a known history of hypersensitivity to original or reformulated xyntha or any component of the product. * patients with a known history of hypersensitivity to hamster protein. * patients participating in an interventional trial of any investigational drug or device.
peristeen bowel irrigation system in cauda equina

Conditions: Cauda Equina Syndrome

Summary: to compare the peristeen anal irrigation system with conservative bowel management in a prospective study among spinal cord injured patients with lower motor neuron neurogenic bowel dysfunction.

people with spinal cord injury (sci) often have severe problems with management of bowel function, including incontinence, impaction, lengthy bowel routines and extremely slow transit times.the anal irrigation system is a recently available system to help patients with bowel dysfunction empty their bowels by using pulse water irrigation. the system consists of a rectal balloon catheter, manual pump and water container.

Eligibility criteria:
inclusion criteria: * male or female \>18 years or older * cauda equina spinal injury at least 12 months previously, with lower motor neuron bowel dysfunction and at least one of the following symptoms: * spending 30 minutes or more attempting to defecate each day or every second day * episodes of fecal incontinence once or more per month * abdominal discomfort before or during defecation exclusion criteria: * coexisting major unresolved physical problems due to the injury * performance of transanal irrigation on a regular basis * evidence of bowel obstruction or active inflammatory bowel disease * history of cerebral palsy, stroke, multiple sclerosis or diabetic polyneuropathy * previous colorectal or perineal surgery(excluding minor surgery such as hemorrhoidectomy) * pregnancy or lactation * immunosuppression * prior implant for sacral nerve stimulation

Keywords: peristeen bowel irrigation system cauda equina syndrome lower motor neuron neurogenic bowel
chronic pain in spinal cord injury

Conditions: Spinal Cord Injuries; Pain

Summary: this trial tests the effectiveness of the drug amitriptyline vs placebo to relieve chronic pain in adults that have had a spinal cord injury.

this double masked placebo-controlled trial will randomize patients (n=100) with a greater than 6 month history spinal cord injury and a greater than 3 month history of associated pain to a daily dose of amitriptyline or placebo for 6 weeks. patients will be examined before randomization by a study physician or nurse masked to their treatment assignment. they will be assessed by telephone interview before, during treatment, at the end of treatment and 4 months later to assess pain, pain interference with activities, physical and mental health, and number of health care visits for pain.

Eligibility criteria:
inclusion criteria: * spinal cord injury six months ago or longer * pain for 3 months or longer exclusion criteria: * history of cardiovascular disease, seizures, or glaucoma * currently taking antidepressant medications * currently hyperthyroid or taking thyroid medicine * currently pregnant

Keywords: spinal cord injury (sci) chronic pain amitriptyline