Kornimate/medical-research-clean huggingface dataset:
long term physical training in asthma

Conditions: Asthma

Summary: this controlled study is undertaken to investigate the effects of a long term outpatient training program on physical fitness and quality of life in elderly asthmatics.

physical training is well known to support a healthy lifestyle. patients with asthma are often unnecessarily restricted of physical activities or avoid exercise due to the unpleasant experience of exercise-induced dyspnea. as a consequence both children and adults with asthma are less fit than their peers. like in healthy individuals, regular training supports health in asthmatics. in short-term training programs improvements of physical capabilities have been achieved in children and young adults with asthma. programs of longer durations than 3 months have not been published in controlled trials. effects of exercise training on quality of life in adult asthmatics are lacking.

Eligibility criteria:
inclusion criteria: * physician diagnosed asthma * non-smoker * stable condition * informed consent exclusion criteria: * participation in pulmonary rehabilitation in the past 12 months prior to study inclusion * unability to attend training sessions on a regular basis for one year * symptomatic coronary heart disease * uncontrolled heart failure * hemodynamically relevant cardiac rhythm disorders * hemodynamically relevant cardiac valvular disorders * uncontrolled arterial hypertension * hypercapnic respiratory failure * severe hypoxemia (i.e. pao2 \<50 mm hg resp. sao2 \<80% at rest) * history of decompensated right heart failure * pulmonary arterial hypertension (pa mean pressure at rest \>20 mm hg) * severe osteoporosis * severe airway obstruction (fev1 \<50% predicted, fev1 \<60% predicted following bronchodilatation) * maximum work rate of less than 50 watt during ergometer testing * uncontrolled asthma * copd exacerbation * severe adipositas (bmi \>35 kg/m2)
dose-response of ketamine in patient controlled analgesia in orthopaedic surgery patients

Conditions: Pain, Postoperative

Summary: to study the multimodal protocol combining adjunct ketamine with oxycodone in intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation


Eligibility criteria:
inclusion criteria: * 20 - 75 years of age * scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia. * written informed consent from the participating patient exclusion criteria: * a previous history of intolerance to the study drug or related compounds and additives * concomitant drug therapy with opioids or strong cyp3a4 or cyp2b6 inductor(s) or inhibitor(s) 2 weeks prior to study. * patients younger than 20 years and older than 75 years. * bmi \> 35, sleep apnoea, any other sleep disorder or condition that requires treatment with continuous positive airway pressure or automatic positive airway pressure device. * existing significant liver or kidney disease * history of ischemic heart disease or conduction disturbance * history of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent * donation of blood for 4 weeks prior and during the study.
multicenter cts pre-and post-transplantation covid-19 serum studies

Conditions: Covid19; Kidney Transplant; Complications; Kidney Transplant Failure and Rejection; Liver Transplant; Complications; Liver Transplant Failure and Rejection

Summary: the covid-19 serum study is a prospective case-control study in 1. kidney or liver transplanted patients being hospitalized due to an infection with severe acute respiratory syndrome coronavirus type 2 (sars-cov-2) after transplantation (tx) (post-tx covid-19 serum study) or 2. patients receiving kidney or liver transplantation after having had a sars-cov-2 infection (pre-tx covid-19 serum study) the aim of this study is to evaluate the development of de novo donor specific antibodies (dndsa) in transplanted patients being hospitalized due to an infection with sars-cov-2 (post-tx covid-19 serum study) as well as in patients receiving kidney or liver transplantation after having had an infection with sars-cov-2 prior to transplantation (pre-tx covid-19 serum study). further, the investigators will evaluate possible consequences of having had a sars-cov-2 infection prior or after liver or kidney transplantation with regard to graft survival and incidence of graft rejection episodes as well as sars-cov-2 specific antibody development after sars-cov-2 infection.


Eligibility criteria:
inclusion criteria: * kidney-transplant recipients and full-size liver-recipients (de-novo or re-transplanted) * participant or legal guardian is willing and able to give informed consent for participation in the trial * sars-cov-2 infection before transplantation (pre-tx covid-19 serum study) or after transplantation (post-tx covid-19 serum study) specific inclusion criteria for pre-tx covid-19 serum study: * kidney or liver transplantation between dec 17,2020 - dec 17, 2021 specific inclusion criteria for post-tx covid-19 serum study: * hospitalization due to sars-cov-2 infection in between dec 17,2020 - dec 17, 2021 exclusion criteria: * participants not meeting the inclusion criteria * multi-organ transplant recipients

Keywords: covid-19 sars-cov-2 kidney transplantation liver transplantation donor-specific antibodies dndsa
observational program neo-penotran® forte

Conditions: Vaginal Candidiasis; Bacterial Vaginosis; Trichomonal Vaginitis

Summary: vaginitis is the most common gynecologic diagnosis in the primary care setting. in approximately 90 percent of affected women, this condition occurs secondary to bacterial vaginosis, vulvovaginal candidiasis, trichomoniasis or mixed infection. neo-penotran forte is registered for treatment of these most common vaginal infections. efficacy and safety of this product is already established, and this observational study was designed to learn more about practical use of neo-penotran® forte in real life setting.


Eligibility criteria:
inclusion criteria: * patients older than 18 years with previously taken decision of their gynecologist to prescribe neo-penotran forte according to registered indications, and microbiological tests were performed. exclusion criteria: * presence of contraindications according to package insert.

Keywords: vaginal candidiasis bacterial vaginosis (also known as non-specific, or gardnerellosis, or anaerobic vaginosis) trichomonal vaginitis vaginitis due to mixed infection
brain plasticity underlying acquisition of new organizational skills in children

Conditions: ADHD; Attention Deficit Hyperactivity Disorder; Neurodevelopmental Disorders

Summary: organizational, time management and planning (otmp) skills deficits are impairing features of developmental disorders, such as attention deficit hyperactive disorder (adhd), which compromise school performance and family relations. the manualized organizational skills training program (ost) was designed to target children's specific otmp deficits. however, the brain mechanisms of treatment-induced changes remain unknown. the current study combines a training intervention (ost) with non-invasive mri imaging in a pre-/post-design in a randomized two-arm (treatment vs. waitlist) trial to address this question.


Eligibility criteria:
inclusion criteria: * age at entry: age ≥ 8.0 and ≤ 11.9 years corresponding to grades 3-5 * written assent by child and consent by parent or legal guardian * iq: estimated full scale iq ≥ 85 and language comprehension scores ≥ 8 * organizational skills deficits defined as elevated (≥ 1sd) pre-treatment children's organizational skills scales (coss) parent total t-score and at least one coss parent interference item rated as either a 3 or 4 (indicating an above-average level of impairment) * must provide adequate mri data at baseline exclusion criteria: * enrolled in a self-contained special education classroom or served by a 1:1 paraprofessional in their classroom * absence of signed consent by parent or legal guardian * children who dissent regardless of parental permission * full scale iq \< 85 * children with a recent (past 6 months) or current history of neuroleptic treatment or current treatment with psychotropic medications other than stimulants * per history (and medical records if needed) medical illness requiring chronic current treatment * history of intrathecal chemotherapy or focal cranial irradiation * premature birth (\< 32 weeks estimated gestational age or birth weight \< 1500g) * history of leukomalacia or static encephalopathy, intracerebral hemorrhage beyond grade 2, other specific or focal neurological or metabolic disorder including epilepsy (except for resolved febrile seizures) * history of traumatic brain injury * contraindication for mri scanning (metal implants, pacemakers, metal foreign bodies or pregnancy)
cma-676 in treating older patients with acute myeloid leukemia in first relapse

Conditions: Leukemia

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of cma-676 in treating older patients who have acute myeloid leukemia that has recurred for the first time following at least 3 months of complete remission.

objectives: i. assess the efficacy of cma-676 in elderly patients with acute myeloid leukemia in first relapse in terms of the number of patients attaining a complete remission. ii. assess the safety of cma-676 in this patient population. outline: this is an open label, single arm, multicenter study. patients receive 1 course of cma-676 iv over 2 hours on day 1 followed by a 6 hour observation period. patients may receive 1 additional course of therapy 15 to 28 days later. there is a 28 day follow-up period after the last dose of study medication. patients are followed for an additional 6 months, then every 3 months for 18 months, and then every 6 months until relapse and/or death. projected accrual: a total of 23-55 patients will be accrued for this study within 12 months. enrollment will then be extended for up to an additional 55 patients.

Eligibility criteria:
disease characteristics: cd33 positive acute myeloid leukemia in first relapse at least 3 months of complete remission no history of a secondary leukemia evolving from a known prior myelodysplastic syndrome or resulting from exposure to chemotherapy or toxins no active cns leukemia patient characteristics: age: 60 and over performance status: ecog 0-2 life expectancy: not specified hematopoietic: wbc less than 30,000/mm3 at time of cma-676 administration hepatic: bilirubin no greater than 2.0 mg/dl renal: creatinine no greater than 3.0 mg/dl cardiovascular: no uncontrolled cardiac disease pulmonary: no uncontrolled pulmonary disease other: no other active malignancy no uncontrolled, life-threatening infections able to obtain bone marrow aspirate hiv negative prior concurrent therapy: biologic therapy: no prior bone marrow and peripheral blood stem cells transplantation no prior anti-cd33 antibody therapy chemotherapy: prior cytotoxic chemotherapy for aml allowed no prior chemotherapy for aml in first relapse except hydroxyurea at least 24 hours since prior hydroxyurea recovered from prior antineoplastic therapy (except alopecia) no concurrent cytotoxic chemotherapy endocrine therapy: no concurrent immunosuppressive therapy radiotherapy: not specified surgery: not specified other: at least 4 weeks since prior investigational agents no other concurrent antileukemic therapy

Keywords: recurrent adult acute myeloid leukemia
an evaluation of clotting factor activity before and after total hip arthroplasty

Conditions: Arthroplasty, Replacement; Coagulation Factors

Summary: the objective of the study was to analyze both the concentration and the activity of the clotting factors, d-dimer levels, as well as fibrinogen concentration in patients who underwent primary total hip arthroplasty due to idiopathic arthrosis. blood loss is often related to perioperative period and may result in decrease of concentration of coagulation factors, which in turn may lead to increased bleeding. we analyzed data of thirty patients scheduled for primary hip arthroplasty: the activity of clotting factors ii, viii, x, as well as fibrinogen concentration in the following time points: (i) before surgery, (ii) six hours after the procedure, and (iii) two, (iv) four, and (v) six days after the operation. all laboratory tests were performed using automatic analyzer. at the same time intervals, an immunoenzymatic assay was used to determine d-dimer levels.


Eligibility criteria:
inclusion criteria: * patients qualified for primary hip arthroplasty for idiopathic osteoarthritis exclusion criteria: * hip osteoarthritis because of non-idiopathic etiology * history of venous thromboembolism or arterial embolism * anticoagulation treatment, * coagulopathy * infection, and * renal failure defined as a creatinine clearance below 50 ml/minute.

Keywords: total hip arthroplasty coagulation factors venous thromboembolism
effectiveness of cosmetic therapy on self-esteem and depression for elderly residents in long-term care institutions

Conditions: Long-Term Care; Aged

Summary: cosmetic therapy provides a psychological effect on the elderly, improving their self-confidence and social participation. this study was conducted to investigate the effectiveness of cosmetic therapy to enhance the self-esteem and reduce depression of elderly residents in long-term care institutions. we expect that a 6-week cosmetic therapy will improve the elderly's mental health, including depression and self-esteem.


Eligibility criteria:
inclusion criteria: * aged over 65 years old. * having been admitted to a long-term care institution (conservation type) for three months. * be able to communicate in mandarin, taiwanese and written languages. * the total score of mini-mental state examination (mmse) is higher than 24 points. * the muscle strength of the left or right hand is 4 points (inclusive) or above, and the maintenance and makeup procedures can be operated with one or both hands. * after the researcher's explanation, the participant is willing and able to give informed consent for participation in the study. exclusion criteria: * under the age of 65. * the applicant has been admitted to a long-term care institution (conservation type) for less than three months. * unable to communicate in mandarin, taiwanese and written language. * participated in cosmetic therapy. * diagnosed with mental illness (except depression), dementia and delirium. * currently taking antidepressant drugs. * currently receiving depression-related treatment. * the maintenance and makeup steps cannot be operated with assistance. * failure to sign the research consent form.

Keywords: elderly residents long-term care institution depression self-esteem cosmetic therapy
study for the early diagnosis of parkinson's disease

Conditions: Parkinson's Disease, Idiopathic

Summary: the main objective of the study is to design and validate the blood based pdx gene expression and mirna assay for the early diagnosis of parkinson's disease patients. differential diagnosis includes patients with multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, lewy body dementia, essential tremor and normal controls.

in this study, the pdx assay will be designed and validated in order to distinguish between idiopathic parkinson's disease (pd) to patients with similar symptoms and healthy controls. the differential diagnosis cohort includes patients diagnosed with multiple system atrophy (msa), progressive supranuclear palsy (psp), corticobasal degeneration (cbd), essential tremor (et) or lewy body dementia (lbd) and healthy controls. this is a prospective observational study. blood samples and clinical data will be collected at the first and only study visit. the expression levels of 5 to 6 genes will be analyzed by blinding technicians concerning the diagnosis, demographic data and clinical data, which will be revealed after sending pdx gene expression values to the clinical sites. the gene expression levels will be compared between parkinson's disease patients to the differential diagnosis cohort and healthy controls. additional mrna and mirna markers will be explored. the primary aim of the study is to design and validate a clinical classifier that will aid the physician in the diagnosis of parkinson's disease patients. the analysis will be performed in two stages: stage 1) exploration analysis and stage 2) validation. after one year of taking a blood sample, the study physician will contacted to confirm the patient's diagnosis. blood samples will be collected at specialized movement disorder clinics. medical history, clinical diagnostic features, family history in regard to parkinson's disease, use of medication and routine imaging assessment (not mandatory) will be collected at the first and only patient visit.

Eligibility criteria:
inclusion criteria: * patient is able and willing to read the informed consent form * patient with clinical diagnosis of idiopathic parkinson's disease according to queen square brain bank criteria up to one year prior to enrollment in study * patient with diagnosis of msa, psp, cbd, lewy body dementia, essential tremor or healthy control * men and women aged 40-80 years * willing and able to comply with procurement of blood sample exclusion criteria: * any medical, psychiatric or other conditions which, in the opinion of the investigator, would preclude participation * pregnancy

Keywords: diagnosis
hand grasping techniques on eliciting the grasp reflex in patients with dementia

Conditions: Dementia

Summary: in this study, the investigators will determine the difference between the two techniques used to elicit the grasp response in patients with frontal lobe dysfunction, primarily in dementia patients versus control patients.

the goal of this project is to determine the optimal technique to elicit the grasping response in patients with dementia or suspected frontal lobe dysfunction. the proposed study is to perform two techniques to elicit grasp response in patients with dementia or suspected frontal lobe dysfunction and observe the presence or absence of the response and prominence of the response on a proposed rating scale. future goals will be aimed at aiding clinicians in refining their clinical techniques to be more sensitive for diagnosing frontal lobe dysfunctions.

Eligibility criteria:
inclusion criteria: 1. ability to sign informed consent or have a surrogate present to sign the consent 2. age 18 or above 3. patients are diagnosed with dementia, alzheimer's disease, or frontal lobe dysfunction 4. medications are to remain stable during the course of the study except for emergency modifications. exclusion criteria: 1. inability to obtain informed consent from patient or surrogate 2. unable to follow commands. 3. physical restrictions (i.e. spasticity of hands/arms, upper extremity amputation) 4. other comorbidities such as muscular diseases, hepatic encephalopathy, renal failure, down syndrome, nph, depression, and cerebral palsy.

Keywords: dementia
otoferlin gene-mediated hearing loss natural history study

Conditions: Sensorineural Hearing Loss, Bilateral

Summary: this is a retrospective and prospective longitudinal study in participants with otoferlin gene-mediated hearing loss.


Eligibility criteria:
inclusion criteria: 1. clinical presentation of bilateral sensorineural hearing loss (snhl), including auditory neuropathy (an) / auditory neuropathy spectrum disorder (ansd) phenotype or medical history of an / ansd phenotype earlier in life 2. mutation(s) in the otoferlin gene 3. able and willing to comply with all study requirements, as evidenced by successful completion of the informed consent (and assent, if applicable) process additional criteria for inclusion in the prospective phase: 4. presence of oae / cm and absent / abnormal abrs in at least one ear (that does not have a cochlear implant) within 12 months prior to or at the month 0 visit exclusion criteria: 1. unwillingness or inability of the potential participant and/or legally authorized representative to comply with all protocol requirements 2. presence of cochlear nerve deficiency and/or cochlear nerve dysplasia additional criteria for exclusion from the prospective phase: 3. presence of bilateral cochlear implants at the time of record review or planned within the next 6 months 4. presence of middle ear or auditory brainstem implant(s) at the time of record review or planned within the next 6 months 5. any condition that would not allow the potential participant to complete follow-up assessments during the course of the study and/or, in the opinion of the investigator, makes the potential participant unsuitable for the study note: potential participants will not be excluded based on their sex, gender, race, or ethnicity

Keywords: otoferlin gene, sensorineural hearing loss (snhl), auditory neuropathy, auditory neuropathy spectrum disorder
combining data sources to identify effect moderation for personalized mental health

Conditions: Depressive Disorder, Major

Summary: this work will extend and apply methods for modeling heterogeneous treatment effects when multiple studies are available, with a particular focus on the complexities in mental health research. the methods will be illustrated in examples estimating the effects of medical treatments for major depressive disorder (duloxetine and vortioxetine) using 4 randomized controlled trials (available in the vivli trials resource) and non-experimental data from the duke university health system electronic health record and the johns hopkins health system electronic health record systems.


Eligibility criteria:
duke university health system electronic health record (ehr) system and johns hopkins health system ehr system inclusion criteria: * all patients prescribed any duloxetine or vortioxetine in the health systems between 01/01/2015 - 12/31/2021. * and from patients with at least 1-year historical ehr data (burn-in period) without prescribing any of the two medications. during the burn-in period, patients should have at least one encounter in the system, and with no encounters during that time frame when they were prescribed duloxetine or vortioxetine. * and patients age 18-65 years old at baseline. exclusion criteria: - patients prescribed both duloxetine and vortioxetine at baseline would be removed. 4 randomized controlled trials (rcts) inclusion criteria: * male or female * age 18 years or older * major depressive episode according to diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) classification code 296.3x * montgomery-asberg depression rating scale (madrs) total score ≥ 26 * clinical global impression - severity (cgi-s) scale score ≥ 4