Kornimate/medical-research-clean huggingface dataset:
telemedical interventional monitoring in heart failure

Conditions: Chronic Heart Failure

Summary: superiority of additional remote patient monitoring in patients with chf in comparison to usual care in terms of: * reduction of mortality rate * reduction of hospitalizations * increasement of patients' quality of life

the clinical trial assesses 710 patients over a period of at least 15 months each (2008 until 2010); all participants will continue to receive usual care from their gp. all patients will be examined at the beginning of the study and will undergo a check-up every 3 months. 355 of the patients will be randomly allocated to receive devices for remote patient monitoring which will measure various parameters on a daily basis (e.g., weight, blood pressure, heart rate). the devices are mobile and can be used at home or elsewhere.

Eligibility criteria:
inclusion criteria: 1. ambulatory chf nyha ii or iii 2. lvef ≤ 35% and cardiac decompensation with hospitalization for heart failure or therapy with intravenous diuretics (.40 mg furosemide/day) within 24 months prior to enrolment or lvef ≤ 25%, measured twice within past 6 months 3. optimal medical treatment for chf (b-blocker, ace-inhibitor/ arb, diuretics) including icd/crt if indicated 4. age ≥ 18 years 5. informed consent exclusion criteria: 1. existence of any disease (hf excluded) reducing life expectancy to less than 1 year 2. insufficient compliance to telemonitoring or study visits 3. impairment to use the telemonitoring equipment or appear to study visits (e.g. dementia, impaired self-determination, lacking ability to communicate) 4. pregnancy 5. concurrent participation in other therapy trials 6. hospitalization for cardiac decompensation within 7 days before inclusion in trial 7. implanted cardiac assist system 8. unstable angina pectoris 9. congenital heart defect 10. primary heart valve disease 11. hypertrophic or restrictive cardiomyopathy 12. arrhythmogenic right ventricular cardiomyopathy 13. acute myocarditis diagnosis ,1 year 14. actively listed for heart transplantation 15. planned revascularization or crt implantation 16. chronic renal insufficiency with creatinine .2.5 mg/dl 17. liver cirrhosis 18. known alcohol or drug abuse

Keywords: telemedicine remote patient monitoring chronic heart failure mortality health economics
clinical trial to examine effectiveness of a human allograft for treatment of dfu and vlu

Conditions: Determine Effectiveness of Theraskin in the Treatment of DFU and VLU

Summary: retrospective clinical study of 188 patients to examine effectiveness of human cryopreserved allograft in the treatment of diabetic foot ulcers and venous leg ulcers

retrospective observational study of 188 consecutive patients to examine the efficacy of biologically active cryopreserved human skin allograft (theraskin) on the treatment of diabetic foot ulcers and venous leg ulcers

Eligibility criteria:
inclusion criteria: 1. theraskin applied to lower extremity wound during the study period. 2. over 18 years of age. 3. males and females. 4. lower extremity wound due to diabetic neuropathy or venous insufficiency. 5. documented palpable pedal pulse (dorsalis pedis and/or posterior tibialis arteries and/or palpable bypass graft), or ankle brachial index (abi) in the range of \> 0.8 to \ 40 mm hg from the foot at the time of the initial allograft applicaton 6. in subjects with multiple wounds only the largest wound receiving the allograft was included and considered the target wound 7. initial wound size \>1 cm 2 8. all wound locations within the lower extremity (defined as below the knee) and wound durations included 9. concomitant negative pressure wound therapy was allowed as this could have been an anchoring technique for the allograft 10. concomitant antibiotics ( topical, oral, or intravenous) were allowed as it was not possible to determine whether administration of antibiotics was due to a true infection at the target wound site. exclusion criteria: 1. wound etiologies other than diabetic neuropathy or nevous such as trauma, burns, sickle cell anemia, necrobiosis lipoidica , pyoderma gangrenosum. 2. wound not present for at least 30 days and showing lack of progression for at least 30 days prior to application of theraskin. 3. other ulcer treatments besides study allograft during the study period ( study period definition: time of first allograft application up to 20 weeks) were not included in this study. these concomitant treatments specifically include hyperbaric oxygen treatments, venous ablation procedures, revascularization procedures including lower extremity bypass grafts or angioplasties or stents, application of additional growth factors, biologic products containing cells or other tissue-derived products, matrix components, or enzymatic debriders. subjects were allowed to receive standard of care therapy with the study allograft, which included debridement, moist dressings or compression dressings depending on wound etiology, and off-weighting depending on wound location. 4. patients with revascularization procedures (defined as lower extremity bypass grafts, angioplasties, or stents) within 30 days of initial theraskin application were excluded 5. patients with successful surgical correction or intervention aimed at improving venous return in the target limb, such as venous ablation procedures, within 30 days of initial theraskin application were excluded
descriptive analysis of near infrared spectroscopy in critically ill and injured pediatric and neonatal patients

Conditions: Stroke; Diabetic Ketoacidosis; Increased Intracranial Pressures; Altered Mental Status

Summary: this study involves looking at cerebral oximetry measurements in pediatric and neonatal patients who are experiencing a critical illness. such as altered mental status, seizures, trauma, sepsis, etc.

at arkansas children's hospital (ach) pediatric emergency department (ped), nirs cerebral tissue oxygenation rso2 monitoring has become an adjunct noninvasive monitoring assessment tool along with pulse oximetry and end-tidal co2 in the critically ill and injured neonatal and pediatric patients' resuscitation endeavors or management. this has become a standard monitoring tool for patients who require medical (possible strokes, diabetic ketoacidosis, increased intracranial pressure, altered mental status, sepsis, drowning, shock, rapid sequence intubations, seizures, altered mental status, strokes, possible shunt malfunctions) or trauma (non-accidental trauma, level one or two trauma with altered mental status, traumatic brain injury, altered mental status with trauma history, vascular compromise) resuscitation efforts. data will be collected as a retrospective and prospective chart review from the electronic medical record of patients that were treated in the pediatric emergency department of arkansas children's hospital from 10-1-13 who require medical (possible strokes, diabetic ketoacidosis, increased intracranial pressure, altered mental status, sepsis, drowning, shock, rapid sequence intubations, seizures, altered mental status, strokes, possible shunt malfunctions) or trauma (non-accidental trauma, level one or two trauma with altered mental status, traumatic brain injury, altered mental status with trauma history, vascular compromise) resuscitation efforts. this study will be based on the patient information recorded in these records, such as age, medications delivered, vital signs, interventions and outcomes and compared to their ped nirs cerebral tissue oxygenation rso2 data. all study subject materials will be assigned a unique identifying code or number. the cerebral nirs rso2 data will be collected/graphed and de-identified.

Eligibility criteria:
inclusion criteria: * trauma: non-accidental trauma, level one or two trauma with altered mental status, traumatic brain injury, altered mental status with trauma history, vascular compromise * or medical: possible strokes, diabetic ketoacidosis, increased intracranial pressure, altered mental status, sepsis, drowning, shock, rapid sequence intubations, seizures, altered mental status, strokes, possible shunt malfunctions exclusion criteria: * none
the effectiveness of mindfulness on chronic pain in breast cancer survivors

Conditions: Breast Cancer; Chronic Pain

Summary: a recent epidemiologic survey has indicated that approx. 42% of danish women treated for breast cancer experience negative sequelae in the form of pain following treatment. chronic pain is known to be associated with impaired social and emotional functioning, and thus presents a particular concern. mindfulness-based intervention is among the complementary, psychological treatments, which cancer patients commonly seek out in relation to the course of their illness. despite the popularity of mindfulness-based intervention among cancer patients, no studies have so far investigated the effect of mindfulness-based intervention on chronic pain in breast cancer patients. while no studies so far have focused on pain, there is evidence to suggest that mindfulness-based intervention is associated with improved psychosocial adaption to cancer. furthermore, non-cancer research suggests that mindfulness-based intervention is associated with reduced pain experiences. the aim of this project is to investigate the effect of mindfulness-based cognitive therapy (mbct) on chronic pain in breast cancer patients. women who have completed their treatment for breast cancer and who experience chronic pain, will be randomized to an intervention group (mbct) or a treatment-as-usual control group. all participants will be assessed at the same time points, i.e. before the intervention (baseline), and three times after the intervention/control condition, with the last follow-up 6 months after the intervention. in addition, a number of potential moderators and mediators of the outcome will be explored. for example, recent studies indicate that adult attachment style may constitute an important moderator and/or mediator in the development of pain, and preliminary research has suggested that attachment style may moderate the effect of mindfulness-based intervention. the results will provide valuable new knowledge about the potential of mbct as a treatment strategy for chronic pain in breast cancer patients, will contribute to the clarification of underlying mechanisms in the experience of and coping with pain, which could help the development of more effective, individualized interventions.


Eligibility criteria:
inclusion criteria: * a timeframe of \>3 months from surgery, radiation- and chemotherapy and a minimum score of \>3 on a pain scale from 0-10 corresponding to moderate pain exclusion criteria: * breast cancer recurrence, bilateral breast cancer, other cancer, psychiatric illnesses, insufficient ability to speak and understand danish, and chronic pain otherwise associated with the musculoskeletal system

Keywords: mindfulness breast cancer chronic pain mediators distress breast cancer survivors effectiveness of mbct on chronic pain potential mediators and moderators effectiveness of mbct on psychological symptoms
efficacy of artesunate-mefloquine combination therapy in trat province, thailand

Conditions: Plasmodium Falciparum Malaria

Summary: the main purpose of this study is to compare artesunate-mefloquine combination therapy given for 2 and 3 days at the same total dose for the treatment of uncomplicated falciparum malaria.

this will be a randomized, open-label comparison of two versus three days artesunate-mefloquine treatment in patients with uncomplicated falciparum malaria. primary endpoints will be 63-day parasitological cure rates in the 2 treatment groups. secondary endpoints will be parasitological failure rates at each of the weekly follow-up visits to day 56, occurence of treatment-emergent adverse events on days 0, 1 and 2, mefloquine blood concentrations on days 7, 14 and 28, and in vitro drug sensitivity profiles for parasite isolates as measured by inhibitory concentrations. genotyping of parasites for known markers of drug resistence will be performed.

Eligibility criteria:
inclusion criteria: 1. age 5 to 70 years inclusive. if aged \< 18 years the subject must have a parent or guardian in attendance. 2. asexual stages of p. falciparum parasites in a thick or thin blood film with no other visible plasmodial species. 3. willing to give informed consent. parents or guardians of children and adolescents must agree to give informed consent. assent is necessary in addition to parental informed consent. 4. able to tolerate oral therapy. 5. willing to attend follow-up appointments and undergo study procedures. exclusion criteria: 1. history of anti-malarial drug use within the past two weeks or mefloquine (mq) use within 4 weeks. 2. bleeding tendency (by history or based on medical records). 3. severe/complicated malaria as determined by the investigator (coma or seizures, pulmonary edema, shock, renal failure, jaundice, severe anemia, spontaneous bleeding, hyperparasitemia (\>5% rbcs infected), or prostration). 4. history of allergy to or intolerance of study medications. 5. mixed malaria infection by giemsa stain. 6. any other condition that in the opinion of the study investigator warrants parenteral antimalarial treatment. 7. pregnant woman or nursing mother

Keywords: artesunate mefloquine plasmodium falciparum thailand uncomplicated plasmodium falciparum malaria
development of an mhealth tool (anímate) to assess self-management, self-care and adherence in people with obesity

Conditions: Obesity

Summary: this trial main purpose is to develop and test an mhealth app aimed at improving self-management, self-care and adherence of people with obesity. the study population are type i or ii obese people, aged more than 18 years old, with or without comorbidities, who have a smartphone or tablet compatible with the app (android version 9.0 or higher) and access to a scale for regular weight monitoring. control group will follow standard care protocol and patients in the intervention group will also be provided with the app. follow-up will be done for 16 weeks. both groups will attend 3 face-to-face visits (baseline, 2 and 4 months).


Eligibility criteria:
inclusion criteria: * patients over 18 years of age. * people with bmi 30-39.9 kg/m2. * have a smartphone or tablet compatible with the app (android version 9.0 or higher) and have sufficient capabilities to use it. * have access to a scale for regular weight monitoring. exclusion criteria: * presence of serious major comorbidities: high blood pressure treated with \> 3 drugs, diabetes mellitus treated with insulin, dyslipidemia treated with pcsk9 inhibitors, sleep apnea-hypopnea syndrome treated with cpap, ischemic heart disease or stroke. * use of pharmacological treatment with influence on weight started in the 6 months prior to study entry. * history of weight loss intervention (diet, exercise) in the 6 months prior to study entry. * history of eating disorder. * history of bariatric surgery. * use of any other app or treatment to lose weight in the 6 months prior to study entry. * pregnancy, short-term gestational desire or lactation. * any other disease or condition that may interfere with compliance with the protocol or completion of the study.

Keywords: obesity mhealth mobile application self-management self-care adherence
using probability of community-acquired pneumonia to tailor antimicrobials among inpatients

Conditions: Pneumonia; Pneumonia, Viral; Pneumonia, Bacterial

Summary: the goal of this prospective randomized study is to improve antibiotic use among hospitalized patients with suspected pneumonia. an alert was built into the electronic health record to guide use of diagnostic testing based on probability of bacterial pneumonia. patients with test results suggesting viral infection will be randomized to either: (1) receive a structured communication from the antimicrobial stewardship team to de-escalate antibiotics or (2) usual care.

low-risk patients with viral pneumonia do not benefit from and may be harmed by antibiotic therapy. in this study, an alert will appear in the electronic health record of patients undergoing molecular diagnostic testing for respiratory symptoms that provides options for diagnostic testing based on pre-test probability of bacterial infection. patients with test results suggesting possible viral infection will be randomized to either usual care or to receive test results along with structured guidance from antimicrobial stewardship to consider discontinuing or de-escalating antibiotics. this guidance, which will include an explicit calculation of the post-test probability of bacterial infection based on considering risk factors, vital signs, symptoms, and available imaging, will be communicated to the primary care team via direct electronic message and a summary note in the patient's chart. the final decision on whether to continue antibiotic therapy will be up to the primary team. the primary outcome of interest will be in-hospital antibiotic use. safety outcomes will include length of stay, readmissions, hospital-free days, and mortality.

Eligibility criteria:
inclusion criteria: * adult patients admitted to the university of maryland medical center or university of maryland medical center-midtown campus who are prescribed antibiotics for suspected community-acquired respiratory infection. * protocol-based diagnostic testing supports possible viral infection, either by positive molecular test or low procalcitonin value. exclusion criteria: * hospitalization for \>72 hours prior to protocol-based diagnostic testing. * previous molecular testing for viral infection during the same hospital encounter. * severely immunosuppressed, defined as having hematologic malignancy, solid organ tumor on chemotherapy, or solid organ transplant on immunosuppression

Keywords: diagnostic stewardship antimicrobial stewardship
a randomized, prospective clinical trial of immediate flap closure versus wound care for management of late-stage pressure ulcers

Conditions: Pressure Ulcer

Summary: the purpose of this study is to compare the number of and degree of pressure ulcers healed, as measured by intact skin at the original ulcer site at 6 months of follow-up in patients randomized to immediate operative closure versus those who are maintained in a wound care program in patients with stage 3 and 4 sacral and peri-sacral decubitus ulcers.


Eligibility criteria:
inclusion criteria: * at least 18 years old; * stage iii or iv pressure ulcers on or near trochanter, ischium, sacrum or buttocks; * receiving treatment at the center for wound management - goleta valley cottage hospital; santa barbara cottage hospital or santa ynez cottage hospital, all part of cottage health system; * underlying etiology for immobility secondary to spinal cord injury (sci) or other neuromuscular condition not expected to become progressive in next 12 months; * no contraindications to undergo surgical intervention, including medical ability to tolerate surgical procedure with general anesthesia. exclusion criteria: * unable or unwilling to provide informed consent; * underlying cause of immobility secondary to chronic medical disease outside of nonprogressive sci or neuromuscular disease as described above; * patients requiring immediate surgical closure determined by physician judgment; * those deemed inappropriate to consider for surgery outside of study; potential reasons normally include medical comorbidities, inability to comply with post-operative care, and lack of funding source for elective procedure, peri-operative, and / or wound care. * patients who have already been receiving active, professionally supervised wound care for \> 2 week period prior to presentation * patient is pregnant or breastfeeding.
efficacy, tolerability, and safety of once-daily atomoxetine hydrochloride versus placebo in russian children and adolescents with attention-deficit/hyperactivity disorder

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: the study is designed to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy (in the morning). it incorporates a 6-week acute treatment period and a 2-week discontinuation phase. the assessments in this study include a standard assessment of adhd symptomatology using a diagnostic and statistical manual of mental disorders, fourth edition™, investigator-administered rating scale.


Eligibility criteria:
inclusion criteria * subjects must have adhd that meets the dsm-iv criteria * aged 6 to 16 years. * subjects must not have taken any medication used to treat adhd. * laboratory results must show no significant abnormalities * baseline ecg results must not show an abnormality * subjects must be able to swallow capsules. * subjects must be of normal intelligence. exclusion criteria * weigh less than 20 kg or more than 60 kg at study entry. * subjects who, after an adequate trial with methylphenidate or amphetamine experience some benefit in adhd signs and symptoms are excluded from participating. * have a history of bipolar i or ii disorder, psychosis, or pdd. * meet dsm-iv criteria for an anxiety disorder. * have a history of any seizure disorder. * patients at serious suicidal risk. * patients with narrow angle glaucoma * subjects who have a history of severe allergies . * have a history of alcohol or drug abuse within the past 3 months * screen positive for drugs of abuse not prescribed by a physician. * have cardiovascular disease and an increased heart rate and blood pressure. * have a medical condition that would increase sympathetic nervous system activity markedly or who are taking a medication on a daily basis. * have severe gastrointestinal narrowing * are during the study time likely to need psychotropic medications. * are likely to begin a structured psychotherapy aimed at adhd symptoms. * have used a monoamine oxidase inhibitor (maoi) during the 2 weeks * female subjects who are pregnant or who are breast-feeding. * are investigative site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. * are, in the opinion of the investigator, unsuitable in any other way to participate in this study. * are employed by lilly.
whole-body vibration versus aerobic exercise on the inflammatory status and hormonal parameters premenstrual syndrome

Conditions: Premenstrual Syndrome

Summary: the purpose of this study is to investigate and compare the effect of whole-body vibration to aerobic exercise on inflammatory status in females with premenstrual syndrome.

premenstrual syndrome (pms) is a complex disorder characterized by moderate to severe symptoms taking place during the luteal phase of the menstrual cycle. it has a negative impact on females' lives, which can affect their relationships, educational efficiency, social activities, and quality of life. despite previous studies reported that physical exercise improves the symptoms of pms, the effects of physical exercise on inflammatory status in females with pms are not clear yet. sixty females allocated to three groups randomly to group (a) that will receive whole-body vibration+supplementation, group (b) that will receive aerobic exercises+supplementation, and group c that will receive supplementation only

Eligibility criteria:
inclusion criteria: 1. females suffering from pms (as determined by pms scale). 2. their ages will range from 18 to 25 years. 3. having regular menstrual cycle. exclusion criteria: 1. smoking. 2. taking any medications. 3. history of chronic disease. 4. having any psychiatric or gynecological problems

Keywords: whole body vibration aerobic exercises premenstrual syndrome