Kornimate/medical-research-clean huggingface dataset:
comparing multicomponent and isometric multicomponent training: impact on fitness, health, and life quality in heart patients

Conditions: Cardiovascular Diseases

Summary: the goal of this clinical trial is to evaluate if a multicomponent training program (mct), including aerobic and resistance exercises, or an isometric multicomponent training program (imct) can improve physiological, physical fitness, mental well-being, and quality of life in adults and elderly with a history of cardiovascular diseases (cvds) currently stabilized. the main questions it aims to answer are: does mct or imct improve physiological parameters, physical fitness, mental well-being, and overall quality of life compared to a waitlist control group (wlcg)? does imct provide superior physiological improvements compared to mct? researchers will compare: * mct (a combination of aerobic, mobility, and resistance training exercises) * imct (a combination of aerobic, mobility, and isometric exercises) to see if these interventions improve health and quality of life outcomes compared to wlcg (participants not engaging in structured physical activity during the study), and if there will be significant physiological differences between mct and imct . participants will: * complete assessments of anthropometric, hemodynamic, physical fitness, and psychological parameters at baseline (t0) and after 24 weeks (t1). * be randomly assigned to one of three groups (mct, imct, or wlcg). * engage in a 24-week structured training program (mct or imct) supervised by exercise professionals, including: * warm-up sessions (10 minutes, low-intensity walking). * main sessions (40 minutes): aerobic, mobility, resistance (mct), or isometric (imct) exercises. * cool-down sessions (10 minutes): breathing and stretching exercises. this study will provide insights into the efficacy of tailored physical activity interventions for individuals with a history of cardiovascular conditions.


Eligibility criteria:
inclusion criteria: * women/men * aged 45-80 years * absence of severe medical conditions (unstable coronary artery disease, decompensated heart failure, severe pulmonary hypertension) or acute onset conditions that would prevent safe participation in physical activity, according to guidelines from the american college of sports medicine (acsm), american heart association (aha), and european society of cardiology (esc). * history of cardiovascular dysfunctions currently stabilized. * sedentary lifestyle (individuals who have not followed who guidelines for aerobic and resistance exercise in the past 3 months). exclusion criteria: * smokers * expected absence of more than one week during the intervention period * lack of a medical certificate for non-competitive sports fitness * severe musculoskeletal or joint disorders with significant mobility limitations * presence of joint pain, dizziness, chest pain, or angina during physical activity * high blood pressure: pbp ≥ 160/100 (untreated)

Keywords: blood pressure physical activity resistance training isometric training health status quality of life
risk taking and fracture study

Conditions: Fracture

Summary: boys suffer a disproportionately large number of fractures compared to girls (55-60%). this study aims to determine why this is the case by identifying risk factors for wrist fractures. the increase in fracture during childhood and adolescence may be associated with 1) risk-taking behaviour in boys, 2) obesity trends in boys during childhood and adolescence, and/or 3) impaired acquisition of bone strength during childhood and adolescence. importantly from a knowledge translation perspective, modifiable factors such as behaviour, dietary habits or physical activity in boys may predict fracture. the investigators will measure 400 children (100 girls and 100 boys who have sustained a fracture; 100 same age and sex friends) across 4 years of growth. this study will assess risk behaviours, diet, physical activity, motor proficiency (i.e., balance and coordination), fat and muscle mass and bone strength to determine if there are, 1) differences in whether all or some of these factors predict fractures in boys compared with girls and, 2) whether these factors track forward similarly in boys compared with girls as children advance through the growth spurt.

the investigators aim to better characterize factors that contribute to fracture in boys and girls and to assess whether such factors track across a four year period. the innovation is to use novel methods and an integrated approach, to measure the influence of risk-taking behaviour, body composition, bone microstructure, motor proficiency, diet and physical activity in one model across growth. this will provide a more comprehensive picture of the key multi-factorial predictors of fracture within- and between-sexes. this essential information will provide the basis for change in public health policy, clinical practice, community programs, and targeted interventions.

Eligibility criteria:
inclusion criteria: * boys aged 9-15 and girls aged 8-13 * fracture to distal radius after low to moderate energy trauma * no other health concerns * healthy (non fracture) subjects for comparison exclusion criteria: * fracture is a result of severe trauma * children with ontological medical conditions

Keywords: wrist fracture adolescents risk taking behaviour bone microstructure
postnatal mhealth intervention development

Conditions: Health Attitude; Knowledge, Attitudes, Practice; Postpartum Depression; Acceptability of Health Care

Summary: this study is a six-week exploratory developmental phase (phase 1) of a larger project to develop an mhealth intervention targeting health education and social support for indian women in the postnatal period. phase 1 of the trial exposes study participants to various intervention modalities and seeks to understand their experiences and perspectives on these using mixed-methods. results from this trial will inform modifications to the intervention to be tested in phase 2.

most mhealth interventions for maternal and child health (mch) in low and middle-income countries, including india, have focused on unidirectional and non-interactive approaches, primarily text messaging. however, ample evidence suggests that provider-led, interactive educational programming and social support are key for improving health behaviors and outcomes. thus innovative mhealth approaches that promote interactive education and facilitate social support have great potential to improve mch outcomes. the two-phase development of messssage will include phase 1: exploratory development on functions and platforms and phase 2: a mixed-methods randomized pilot study using a factorial design of specific intervention functions and platforms confirmed in phase 1. study activities described herein are associated with phase 1. the study's specific aim is: to develop optimal intervention functions, processes, and mhealth platforms for education and peer support among postnatal women in rural india. in phase 1, the investigators will explore potential interactive education and peer support group intervention functions (education, emotional support, instrumental support, referrals, linkages, follow-up on postnatal visits), processes (group interactions; frequency, length and timing of groups; engagement opportunities, participant profiles) and mhealth delivery platforms (voice, text chat, app options, interaction features). this six-week developmental component will include up to four groups (n=48; 12 per group) to assess different modalities and functions. the investigators will ascertain women's preferences for functions, processes, and platform features using survey and in-depth interviews (idis), and capture levels of engagement via back-end data. this process will also inform the intervention's health information content. findings will be used to formalize the group mobile intervention details to be examined in phase 2.

Eligibility criteria:
inclusion criteria: * postnatal (within 2 weeks) * 18+ years old exclusion criteria: * women below 18 years of age * women with high risk pregnancies * women who delivered preterm, suffer severe maternal complications or they or their baby are otherwise sick in the first week
is saxenda® a viable treatment of obese patients in forensic psychiatry?

Conditions: Mental Disorder; Metabolic Disturbance; Feasibility; Overweight and Obesity; Liraglutide

Summary: an open-label, multi-centre, 26-weeks clinical feasibility study. the objective is to explore whether saxenda could be a feasible choice in the treatment of overweight, obesity and weight-related medical problems, in patients diagnosed with a severe mental illness and hospitalized at a forensic department in denmark. we wish to determine the viability of the daily saxenda®-injection treatment in this specific patient group.


Eligibility criteria:
inclusion criteria: 1. informed oral and written consent 2. diagnosed with a mental illness according to the criteria of icd10 3. hospitalised at a forensic psychiatric department during the full inclusion period 4. age 18 years to 65 years (both included) 5. bmi ≥27 kg/m2 with one or more weight-related comorbidities (sleep apnea, hypertension (bt ≥ 140/90 mmhg with no antihypertensive treatment. bt ≥ 130/80 mmhg with antihypertensive treatment), dyslipidaemia (ldl cholesterol ≥ 3 mmol/l), pre-diabetes (hba1c 39-47 mmol/mol) or type 2 diabetes (hba1c ≥ 48 mmol/mol)) or bmi ≥30 kg/m2 exclusion criteria: 1. any use of coercive measures according to the danish law for mental health/psykiatriloven (as defined in "informationsbekendtgørelsen § 10"). 2. fertile females of child-bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant 3. women who are not willing to use an adequate contraceptive considered as highly effective (iud or hormonal contraception during the full length of the study 4. impaired hepatic function (plasma liver transaminases \>2 times the upper normal limit) 5. impaired renal function (serum creatinine \>150 μmol/l and/or macroalbuminuria) 6. impaired pancreatic function (acute or chronic pancreatitis and/or plasma amylase \>2 times the upper normal limit) 7. cardiac problems defined as decompensated heart failure (nyha class iii/iv), unstable angina pectoris and/or myocardial infarction within the last 12 months 8. hypertension with systolic blood pressure \>180 mmhg or diastolic blood pressure \>100 mmhg 9. any condition that the investigator feels would interfere with trial participation 10. use of weight-lowering pharmacotherapy within the preceding 3 months 11. type 1 diabetes 12. patients treated with insulin 13. patients treated with other glp-1 receptor agonist medicines 14. known allergy to liraglutide or any of the ingredients in saxenda®
general vs. intrathecal anesthesia for total knee arthroplasty

Conditions: Arthritis

Summary: hypothesis: general anesthesia as compared to intrathecal (i.e. spinal anesthesia) anesthesia will result in shorter length of hospital stay for patients undergoing total knee arthroplasty. primary endpoint: time from end of surgery until the patient is "street ready" secondary endpoints: will general anesthesia produce less postoperative pain as compared to intrathecal anesthesia? is there any difference in post operative "dizziness" between the groups.

hypothesis: general anaesthesia compared to intrathecal anaesthesia will give shorter length of hospital stay (los) for patients undergoing total knee arthroplasty (tka). primary endpoint: time from end of surgery until the patient meets the discharge criteria. secondary endpoints: 1. will general anesthesia produce less post operative pain? 2. is there any difference in post operative orthostatic function (dizziness) between the groups? 3. time until the patient meets the discharge criteria from pacu 4. how many patients will need at least one urinary bladder catheterization?

Eligibility criteria:
inclusion criteria: 1. patients with osteoarthritis scheduled for surgery 2. patients that will require total knee arthroplasty 3. patients over 45 yrs and under 85 yrs 4. patients that understand the given information and are willing to participate in this study 5. patients who have signed the informed consent document exclusion criteria: 1. prior surgery to the same knee 2. patients with a history of stroke or neurological or psychiatric disease that potentially could affect the perception of pain 3. obesity (bmi\> 35) 4. active or suspected infection 5. patients taking opioids or steroids 6. patients suffering from rheumatoid arthritis or have a immunological depression. 7. patients who are allergic to any of the drugs being used in this study 8. patients with other severe medical problems that could affect the perioperative course.

Keywords: arthritis general anaesthesia spinal anaesthesia
assessment of sleep disturbance in alzheimer disease

Conditions: Alzheimer Disease

Summary: the purpose of this study is to study circadian rhythms, or daily cycles of sleep, wake, and activity. the investigators hope to learn how disturbed sleep in alzheimer's disease relates to changes in activity cycles, and how sleep disturbances may affect your daytime alertness. this project selects patients suffering from memory problems, or voluntary to be in our control group. there are three parts to this study: sleep diaries, behavioral questionnaire, and activity recordings


Eligibility criteria:
inclusion criteria: * alzheimer disease * mmse \> 20 * over 65 years old exclusion criteria: * new psychotropic drug treatment * patient unable to do neuropsychologic tests

Keywords: alzheimer disease sleep disturbance apathy memory loss
absorption of indacaterol and glycopyrronium from ultibro breezhaler

Conditions: Healthy Volunteers

Summary: the objective of this study is to assess pharmacokinetics (pk) of indacaterol and glycopyrronium, and methodology and practical arrangements for future studies.


Eligibility criteria:
main inclusion criteria: 1. healthy males and females 2. 18-60 years of age 3. body mass index 19-30 kg/m2 4. weight at least 50 kg 5. written informed consent obtained main exclusion criteria: 1. evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gi, pulmonary, metabolic, endocrine, neurological or psychiatric disease 2. any condition requiring regular concomitant treatment 3. any clinically significant abnormal laboratory value, vital sign or physical finding that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject 4. known hypersensitivity to indacaterol or glycopyrronium 5. pregnant or lactating females and females of childbearing potential not using contraception of acceptable effectiveness 6. blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration
comparing the outcome of electrical stimulation and physical therapy in patellofemoral pain syndrome

Conditions: Patellofemoral Pain Syndrome

Summary: the purpose of study is to evaluate the efficacy of the electrical muscle stimulation (ems) device in patients with patellofemoral pain known as anterior knee pain. usual treatment for it is physical therapy (pt). we want to evaluate and see if adding the electrical muscle stimulation will fasten the recovery and improved outcome in patellofemoral pain syndrome. half of participants will receive ems and pt while other half will receive pt only.

the patellofemoral pain syndrome also known as anterior knee pain is a common entity in young athletic population. in patellofemoral knee syndrome, one of the theory is that the vastus medialis obliquus muscle is weak. to strengthen the muscle, physical therapy exercises are commonly used. this study evaluates addition of the electrical muscle stimulation device.the electrical muscle stimulation device "flex mt plus" (electrostim medical services inc. tampa, fl) is a fda approved device and has been used in knee for other conditions like treating for weakness associated with knee injuries or after knee surgeries. it has shown to improve the outcomes in above mentioned conditions. its efficacy has been tested in patellofemoral pain syndrome but in smaller sample size. we intend to test it in larger sample size patient population. bily et al (2008) (reference #1) published their results on patellofemoral pain syndrome comparing ems +pt to pt only and found that overall significant improvement in outcome score in all patients but when compared between the groups there was no difference. but there sample size was 19 patients in each group. small sample size was one of the limitation of their study. we intend to collect 46 patients in each group to find significant difference based on power analysis.

Eligibility criteria:
inclusion criteria: * bilateral/unilateral anterior knee pain for more than 3 moths * age of patient 18 to 40 years * at least 3 of the 4 following criteria present: pain associated with prolonged sitting with knees bend, pain with going downstairs, kneeling and squatting or sports activities * no h/o injury * no h/o surgery to the knee exclusion criteria: * h/o patellar dislocation or subluxation * associated bursitis, tendinitis in periarticular area * ligamentous problems * intra-articular pathology * pregnancy (patient reported pregnancy, in case of doubt patient will be referred to their obg/gyn physician to exclude the pregnancy) * h/o knee surgery * oral or intraarticular administration of steroid medication with in last 3 months * patients with implanted devices like pacemaker

Keywords: anterior knee pain
natalizumab in inclusion body myositis (ibm)

Conditions: Inclusion Body Myositis (IBM)

Summary: muscle biopsies of patients with inclusion body myositis (ibm) have demonstrated a t-cell predominant inflammatory infiltrate, therefore, new agents targeting t -cell mediated cell death may be a novel treatment for ibm. such an agent capable of preventing t-cell movement out of the vasculature, such as natalizumab, may be beneficial in ibm patients. six patients will be recruited to participate in this phase i trial.

this is a phase i open label, non-placebo controlled trial evaluating the safety and efficacy of natalizumab in patients with ibm. pre and post treatment muscle biopsies including measurements of the degree of inflammation as well as the types of inflammatory cells will be measured. the investigators will also assess quality of life, the inclusion body myositis functional rating score (ibm-frs), and patient and physician global impression of change. manual muscle testing and quantitative dynamometry will also be evaluated to see if patient's strength improves. patients who are eligible to participate and have signed a consent form will have a muscle biopsy performed at baseline and at the end of the study. physical and neurological exams, as well as ibm-frs, safety labs will be conducted and collected at monthly visits. patients will start natalizumab therapy at 300mg intravenously every 4 weeks for 24 weeks. all study related procedures will be conducted at phoenix neurological associates, as well as all infusions and muscle biopsies

Eligibility criteria:
inclusion criteria: 1. definite diagnosis of sporadic ibm through previous muscle biopsies 2. age 21-85 3. fvc\> 50% 4. muscle function adequate for quantitative muscle testing 5. jc virus negative at screening exclusion criteria: 1. previous therapy with natalizumab. 2. treatment with other immunosuppressive agents within the last 12 months 3. quadriceps strength less than or equal to 2/5 at baseline 4. known malignancy 5. pregnancy or breastfeeding 6. history of abnormal laboratory results indicative of any significant medical disease that would preclude the use of natalizumab 7. any clinically significant infectious illness in the 30 days before enrollment
patterns of inclisiran use in the real world: an analysis of us databases

Conditions: Atherosclerotic Cardiovascular Disease; Familial Hypercholesterolemia

Summary: this was a retrospective observational cohort study of patients who initiated inclisiran, alirocumab, or evolocumab in a real-world setting in the united states. the study used data extracted from three databases: (1) open and closed claims from komodo's healthcare map and electronic medical records (emrs) from outpatient clinics affiliated with (2) healix and (3) metro infusion centers. the study period spanned from 01 january 2021 to the latest date of the available data for each database. index date was defined as the date of the first claim for inclisiran, alirocumab, or evolocumab within the patient identification period. the 12-month period prior to the index date (including the index date) was the baseline period. follow-up spanned from the index date up to patient disenrollment, death, or the end of the study period, whichever came first.


Eligibility criteria:
inclusion criteria: * patients with a first claim for inclisiran within the identification period. * patients without a claim for inclisiran and with a first alirocumab claim or first evolocumab claim within the identification period. * patients with 12 months of continuous enrollment (ce) before index, inclusive of index date. additional inclusion criteria for secondary outcome measures: * patients with at least 6-month or 12-month ce period post-index. * patients with continuous use of the index medications. * patients with available low-density lipoprotein cholesterol (ldl-c) measurements at baseline and after treatment initiation. exclusion criteria: • patients with ≥1 prescription claims for the index medications in the 12-month prior-index period (exclusive of index date).

Keywords: low-density lipoprotein cholesterol real-world
mozobil for autologous stem cell mobilization

Conditions: Non-Hodgkin's Lymphoma; Hodgkin's Lymphoma; Stem Cell Mobilization; Autologous Stem Cell Transplantation

Summary: the aim of this study is to evaluate plerixafor (mozobil) plus recombinant human g-csf (g-csf) efficiency in mobilizing sufficient number of stem cells from lymphoma (nhl and hl) patients for autologous transplantation.


Eligibility criteria:
inclusion criteria: patients eligible and planned for an autologous haematopoietic stem cell transplantation. 1.1 eastern cooperative oncology group (ecog) performance status of 0 to 2. 1.2 wbc count ≥2.5x109/l. 1.3 absolute neutrophil count ≥1.5x109/l. 1.4 platelet count ≥100x109/l 1.5 adequate cardiac, renal, hepatic and pulmonary function sufficient to undergo apheresis and transplantation. 1.6 previously, heavily pretreated lymphoma patients or patients suspected to have a poor bone marrow stem cell reserve for at least one of the following: * \>2 lines of chemotherapy. * previous radiotherapy involving bone marrow * prior therapy with specific stem cell toxic chemotherapeutic agents * platelets count pre-mobilisation, ≤150.103 x mm3 * level of circulating cd34+ ≤ 20 cells/mcl prior to apheresis on the collection day * patients \> 60 years of age exclusion criteria: 2.1 lymphoma patients that did not fulfil the inclusion criteria. 2.2 history of any acute or chronic leukemia (including myelodysplastic syndrome. 2.3 prior allogeneic or autologous transplantation. 2.4 inability to tolerate stem cell harvest. 2.5 peripheral venous access not possible. 2.6 pregnant or nursing women. 2.7 positive serology for hepatitis b or c. 2.8 acute infection (febrile, i.e. temperature \> 38c) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of gcsf. 2.9 hiv positive. 2.10 left ventricular ejection fraction \< 50%. 2.11 dlco \< 50%. 2.12 splenectomised or splenic irradiation. 2.13 psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study. 2.14 treatment with other investigational drugs within 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilisation phase.

Keywords: non-hodgkin's lymphoma hodgkin's lymphoma stem cell mobilization autologous stem cell transplantation