Kornimate/medical-research-clean huggingface dataset:
evaluation of safety and efficacy of shorttime tni treatment in patients with copd

Conditions: Oxygen Inhalation Therapy

Summary: evaluation of safety and efficacy of shorttime tni treatment in patients with copd acute testing of oxygen demand using tni vs. standard oxygen application in stable copd patients an investigator-initiated, prospective, controlled, multicenter study

tni, the nasal insufflation of a high flow of warm, humidified air, is an extremely comfortable and uncomplicated alternative to numerous other approaches in non-invasive ventilation (niv). up to now, niv therapy could only be applied by masks with the associated complications as patients could not tolerate high airflow delivered by a thin nasal cannula without humidification and warming, thus causing concomitant negative effects. the new therapy tni shows a high rate of acceptance by children, too. at present, there are two different types of devices available for nasal insufflation in clinics: tni 20s, an air humidifier for clinical compressed air, and the tni20 oxy, an air humidifier for clinical compressed air, which can be combined with oxygen. tni 20 oxy the system, which is unique throughout the world, is optimized for the application of flows of up to 20l/min and fulfils the minimum requirements of the "american society of testing and materials" for a high flow air humidifier in the non-invasive application of 10 mg h2o/l (equivalent to about 60% rel. humidity at an ambient temperature of 22°c) for the air humidity. the warming of the air flow by 5-15°c can be adjusted relative to the ambient temperature. condensation is prevented in the nasal applicator by heating the tube as far as the nostrils. the device automatically controls humidity and temperature depending on the prevailing ambient conditions. the tni®20s can be attached to the hospital infrastructure by means of a standard pressure regulator.

Eligibility criteria:
inclusion criteria: - copd patients with an indication for long-term oxygen therapy age 30 - 80 years copd gold °iii exclusion criteria: - clinical instability of the patient no lung function testing possible exacerbation within the last 14 days prior to inclusion into the study serious concomitant diseases that may jeopardize the inclusion of the patient into the study from the investigator's point of view anaemia, defined by a haemoglobin \<10 g/l patients with hypercapnia, defined by a paco \<46mmhg participation of the patient in any other ongoing study

Keywords: oxygen, insufflation, copd, high flow treatment
metabolic responses to breakfast in adolescent girls

Conditions: Postprandial Hyperglycemia

Summary: breakfast consumption (bc) is frequently associated with a healthy lifestyle, healthy body weight and favourable cardiometabolic health. research from studies in adults suggests that breakfast skipping causes elevated plasma glucose and insulin concentrations after lunch. however, there is currently no evidence to suggest a similar metabolic response in adolescent girls, a population that frequently skips breakfast. the primary purpose of this study is to examine the effects of bc versus breakfast omission (bo) on metabolic responses after lunch in healthy adolescent girls.

breakfast consumption (bc) is habitually associated with a healthy lifestyle (e.g., diet and physical activity), reduced adiposity and favourable cardiometabolic health profiles in children, adolescents and adults. experimental research in adults has shown that breakfast consumption reduces the glycaemic and insulinemic response to lunch when compared with breakfast omission; this has been termed 'the second meal effect'. further, breakfast consumption may improve exercise performance and increase free-living physical activity energy expenditure in adults. understanding the postprandial metabolic responses to bc and breakfast omission (bo) in adolescent girls is particularly important, as this population frequently skips breakfast and have low physical activity levels. yet, adolescent girls may respond differently to adults due to their distinct metabolic profiles, and past research has not targeted this population. the primary aim of this research is to examine whether bc versus bo affects postprandial glycaemic and insulinemic responses to lunch in adolescent girls. secondly, it aims to examine the lipaemic and substrate oxidation responses during rest, substrate oxidation during an exercise bout performed later in the day, and physical activity enjoyment during the exercise bout.

Eligibility criteria:
inclusion criteria: 1. aged 11 to 14 years old 2. female 3. healthy weight body mass index centile (between the 3rd and 91st centile - cole et al 2000) exclusion criteria: 1. allergies to the breakfast and lunch ingredients 2. fitted with a pacemaker 3. unable to walk 4. health related issues that could be affected by participation in the study (e.g., uncontrolled exercise-induced asthma, diabetes, epilepsy)

Keywords: cardiovascular disease diabetes
efficacy of statins in prevention of cin

Conditions: Nephropathy

Summary: to determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of cin.

due to the conflict in the available data, there are no practice guidelines that are established in order to prevent contrast-induced nephropathy (cin). our goal is to determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of cin.

Eligibility criteria:
1. inclusion criteria: * adults \> 18 years of age * undergoing coronary or peripheral angiography with or without intervention * cr \> 1.3 mg/dl or gfr \< 60 ml/min 2. exclusion criteria: * end-stage renal disease on dialysis * acute renal failure * previous iodinated contrast media exposure within 7 days of study entry * history of hypersensitivity to statins * pregnancy or lactation * emergent coronary angiography, st elevation myocardial infarction (stemi), or cardiogenic shock * prisoners * patients already on maximum dose of statins * patient receiving n-acetylcysteine or sodium bicarbonate

Keywords: prevention nephropathy
a study of mabthera/rituxan (rituximab) in patients with relapsed centroblastic centrocytic non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: this study will evaluate the efficacy and safety of mabthera/rituxan in patients with relapsed low-grade centroblastic centrocytic non-hodgkin's lymphoma. patients will receive once-weekly intravenous mabthera/rituxan for 4 weeks; responding patients will be treated a second time in case of relapse (defined as progression after complete or partial response). the anticipated time on study treatment is \<3 months.


Eligibility criteria:
inclusion criteria: * adult patients \>= 18 years of age; * centrocytic centroblastic non-hodgkin's lymphoma stage iii-iv; * relapse after chemotherapy (with or without interferon maintenance therapy). exclusion criteria: * primary refractory lymphomas; * more than 3 relapses of centroblastic centrocytic non-hodgkin's lymphoma; * clinically significant cardiac disease.
pharmacovigilance study to evaluate safety of avodart in subjects with benign prostate hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: this study has 4 phases: screening phase (visit 1), treatment phase (visit 2 - 6 mths after treatment initiation), and end of treatment phase (visit 3 - end of year 1). only in the case a serious adverse event (sae) arises, will there be a follow up phase (visit 4).


Eligibility criteria:
inclusion criteria: * subject should fulfil criteria for the subscription of avodart as these are mentioned in the spc * subject should be diagnosed with benign prostate hyperplasia * subject's prostate volume should be equal or greater than 30 cm3 exclusion criteria: * known hypersensitivity to any of the avodart compounds * suffers from a serious illness which either is not properly controlled or as per investigator´s judgment could interfere with the subject´s compliance into the trial * receives treatment with enzyme inhibitors cyp3a4 and cyp3a5. * history of severe liver failure

Keywords: benign prostate hyperplasia dutasteride pharmacovigilance
prospective functional outcome study of the knee

Conditions: Osteoarthritis of the Knee

Summary: the purpose of this study is to obtain patient-oriented and clinically-oriented physical function outcomes both pre-operatively and post-operatively in patients receiving a total knee arthroplasty .

this study aims to use up to 75 patients at 3 centers to determine a baseline short-term postoperative physical function status of patients undergoing a total knee arthroplasty through patient and clinically based assessments. the koos score will collect data on the patient's physical function, stiffness, and pain. the berg balance, tug, and tuds tests will be used quantitatively to assess the patient's ability to conduct activities of daily living like walking for an extended period of time, standing from a seated position, and maintaining balance while performing a series of actions.

Eligibility criteria:
inclusion criteria: * patient is a male or non-pregnant female age 18 years or older at time of study * patient is a candidate for a total knee arthroplasty * patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation. exclusion criteria: * patients younger than 18 years of age * patients with a primary diagnosis other than osteoarthritis of the knee as determined by an orthopaedic surgeon * patients who have had any previous lower extremity procedure * patients with a bmi greater than or equal to 40 * patients with an active infection within the affected knee joint patients with a neuromuscular or neurosensory deficiency that may limit the ability of the patient to evaluate the safety and efficacy of the device * patient is diagnosed with systemic disease or metabolic disorder leading to progressive bone deterioration (e.g. lupus erythematosus, paget's disease) * patient is immunologically suppressed or receiving chronic steroids in excess of normal physiological requirements (e.g. greater than 30 days) * patient has a known sensitivity to device materials * non-english speaking patients * patient is a prisoner

Keywords: osteoarthritis knee replacement functional testing
optimizing the prehospital use of stroke systems of care-reacting to changing paradigms-implementation (opus-i)

Conditions: Stroke

Summary: this interventional trial will compare a novel prehospital stroke transport algorithm (opus-i) to a traditional prehospital stroke transport algorithm to improve outcomes in rural stroke patients by determining the effect of implementing a data-driven prehospital stroke algorithm on time to and endovascular therapy. the study consists of a multicenter cohort and will last 24 months but individual subject study duration is 90 days.

stroke is the fifth leading cause of death in the united states (u.s.) and causes one in six deaths from cardiovascular disease. intravenous thrombolysis (ivt), unless contraindicated, is the standard of care for acute ischemic strokes (ais) presenting within 4.5 hours of last known well. ivt plus endovascular therapy (evt) is standard of care for the typically debilitating large vessel occlusion strokes (lvos), which represent 30% of ais. however, only a limited number of stroke centers provide evt. currently only 12% of all stroke patients are treated with ivt and only 8% of patients are treated with evt. therefore, optimizing prehospital systems of care to provide timely ivt and evt to all patients. most stroke patients arrive at the hospital by emergency medical services (ems). ems clinicians use various stroke assessment tools to triage patients to the appropriate level of stroke center. unfortunately, these prehospital stroke screen tools are imprecise and can delay care for lvos patients. the choice of transport destination may vary by geography. in an urban area, where several stroke centers of varying capability may be concentrated in a small geographical area, there is negligible impact to the healthcare system if an ambulance bypasses the closest hospital for an esc. in a more rural area, the decision regarding hospital transport destinations has greater implications. transporting a patient to a farther esc will result in a longer transport time and take an ambulance out of its primary coverage for a prolonged time. however, transporting rural stroke patients to their local non-esc may worsen their clinical outcomes by delaying the time to evt. therefore, we propose to implement the novel opus-i prehospital stroke transport algorithm to improve outcomes for stroke patients.

Eligibility criteria:
inclusion criteria: * clinical impression of stroke/tia by ems clinicians exclusion criteria: * age \< 18 years * prisoner
rehabilitation in patients with progressive supranuclear palsy

Conditions: Progressive Supranuclear Palsy

Summary: the investigators evaluate whether an aerobic, intensive, goal based and multidisciplinary rehabilitation treatment, previously conceived for parkinson's disease, is effective for patients with progressive supranuclear palsy and whether a driven gait orthosis (lokomat) can provide further benefits.


Eligibility criteria:
inclusion criteria: a) diagnosis of psp in accordance to the ninds-spsp international criteria (litvan et al., 1996), b) age between 55 and 85 c) ability to walk unassisted for at least 6 meters, d) stable dopaminergic drugs dosage in the month preceding the admission to the study exclusion criteria: a) any others significant neurological or orthopedic disorders, b) osteoarthritis, osteoporosis, cutaneous lesions and/or other pressure wounds, c) body weight exceeding 135 kg (the weight limit for the use of lokomat®), respiratory and cardiovascular diseases.

Keywords: rehabilitation robot-assisted walking training treadmill lokomat
cerebrospinal fluid biomarkers of myotonic dystrophy

Conditions: Myotonic Dystrophy Type 1

Summary: myotonic dystrophy is associated with central sleep apnea, excessive daytime sleepiness, diminished working memory, impaired visuospatial skills, and deficits in problem-solving skills. cerebrospinal fluid (csf) is a clear, colorless fluid that surrounds and protects the brain. changes in the composition of csf can serve as early indicators of changes in brain activity and function. the purpose of this research is to learn about myotonic dystrophy by examining cerebrospinal fluid and brain activity in participants. the tests will be low risk and are well tolerated. the information that we gather from this study may help us evaluate, prevent, diagnose, treat, and improve our understanding of myotonic dystrophy. funding source- fda oopd


Eligibility criteria:
inclusion criteria: * subjects with dm1 based on genetic testing and/or clinical criteria (some subjects who have positive genetic testing may be asymptomatic, while other subjects who show characteristic clinical features may have declined to have genetic testing done). * unaffected subjects are unknown to have myotonic dystropphy or any other muscular dystrophy by history and may have had no genetic testing. * clinical indicators of current status, as measured within 30 days of study start: able to provide informed consent or assent for participation in the study. * demographic characteristics (e.g., biologic sex, age): males and females age 18 years and older. exclusion criteria: * medical history of any of the following. state of immunosuppression; pre-existing liver or kidney disease; documented hiv positive; documented hepatitis b and/or c positive. * medications and other drugs. use of anticoagulants within 60 days prior to lumbar puncture and/or blood draw. use of anti-platelet drugs within 7 days prior to blood draw. * contraindications to mri. the presence of any metal within the body, which would include any medical device containing metal, such as a pacemaker, defibrillator, some heart valves or stents, artificial joint, aneurysm clip, or inner ear device, a history of working with sheet metal, or an injury with metal shrapnel; pregnancy, due to effects of mri on unborn children. * contraindications to lumbar puncture. evidence of increased intracranial pressure or active infection on exam; platelets less than 50,000. * other. inability or unwillingness of the subject to give written informed consent.
worksite program to prevent weight gain among bus drivers

Conditions: Obesity; Cardiovascular Diseases; Heart Diseases

Summary: the purpose of this study is to implement and evaluate a two-year multi-component environmental intervention to prevent weight gain among city bus drivers at four bus garages. it is hypothesized that transit employees in the intervention garages will gain less weight compared to the transit employees in the control garages.

background: environmental influences that support less healthful food choices and sedentary behaviors have contributed to the epidemic increase in overweight and obesity among u.s. adults. worksite settings are an effective channel through which to reach adults with interventions designed to prevent excess weight gain and obesity. design narrative: this study will implement and evaluate a multi-component environmental intervention to prevent excess weight gain among 1200 bus drivers working in four garages in a major metropolitan area. four garages will be randomized to the intervention or control group for a two-year period. the environmental interventions are based on a social ecological framework and target four worksite environmental areas: 1) food availability and incentives; 2) physical activity opportunities and incentives; 3) the social environment; and 4) media/promotion related to health food choices, physical activity, and body weight.

Eligibility criteria:
inclusion criteria: * employed as a bus driver exclusion criteria: * not employed as a bus operator at one of the four participating garages
impact of ginger on menopausal symptoms

Conditions: Menopause

Summary: this study aimed to examine the impact of one gram of zingiber officinale powder on menopausal symptoms since a large number of menopausal women in this region (duhok city in the north of iraq) are reluctant to take the conventional treatment for improving their menopausal symptoms and they prefer of taking the ginger powder and surprisingly many of those patients reported positive effects on their symptoms and general well being.

after taking the scientific and ethical approval from the college of the pharmacy/ university of duhok and the directorate of duhok health (reference number 24102021-10-36) to look at the impact of zingiber officinale on menopausal symptoms in women between 45 and 60 years old. a clinical interventional study was launched at the gynecology department in azadi teaching hospital in duhok governorate, iraq, from december 2021 to may 2022. this study initially recruited seventy women who matched the inclusion criteria. all the recruited women were informed about the study protocols, and they had the option to withdraw from it anytime. after giving written consent, they were randomly divided into one of two research groups through a random number generator software. thirty-five women functioned as controls and were given placebo capsules for twelve weeks (a professional pharmacist formulated a 50mg starch purchased from the local market to look similar to the ginger capsule). the other thirty-five women were given pure zingiber officinale powder (500mg) in capsules twice daily for twelve weeks (zingiber officinale capsules were purchased from pure mountain botanicals, 1712 pioneer ave # 1139 cheyenne wyoming 82001 (usa)). twenty women completed the study in the placebo group, while thirty women completed the survey in the ginger group. unfortunately, fifteen participants from the control group and five women from the treatment group didn't finish the study and were excluded as they were not tighter to the project protocol. the frequency and severity of menopausal symptoms were assessed using an internationally recognized questionnaire menopausal rating scale (mrs). percentage differences between pre-treatment were compared to post-treatments. the serum estrogen, progesterone, fsh, and lh levels were measured before and after treatment using a suitable kit for each hormone by cobas e 411 analyzers (roche diagnostics).

Eligibility criteria:
inclusion criteria: * women living in duhok city with self-reported menopause symptoms * aged between 45 and 60 years exclusion criteria: * not on treatment for menopausal symptoms * patients having chronic diseases like hypertension, ischemic heart diseases or diabetes mellitus * patients having coagulopathies * patient's having hormone-dependent malignancies
use of a digital psychotherapeutic app to reduce symptom burden in dermatology patients

Conditions: Eczema; Psoriasis; Urticaria

Summary: skin diseases, despite low mortality, significantly impair quality of life. this randomised controlled trial evaluates the efficacy of a digital toolkit comprising psychotherapeutic strategies in reducing qol burden in patients with chronic inflammatory skin conditions. this toolkit is hosted on a mobile application and will be used by study participants randomised to the intervention arm over the 32 week study period.

chronic inflammatory skin diseases, despite low mortality, significantly impair quality of life. up to 80% of dermatological patients experience severe itch and poor sleep, and related such mental health challenges as anxiety and depression. the relationship between skin diseases and mental health highlights the challenges that doctors face in treating these conditions. existing psychotherapeutics such as mindfulness training, cognitive behavioural therapy, and acceptance and commitment therapy are widely used and effective in the treatment of mental health illness. however, there is limited evidence on the application of such interventions in dermatology and most mental health apps lack robust clinical evaluation. we report the design of a randomised controlled trial to evaluate the efficacy and implementation of a mobile app containing dermatology-specified psychotherapeutic strategies in reducing qol burden.

Eligibility criteria:
inclusion criteria: * patients with psoriasis, eczema or chronic urticaria diagnosed by a dermatologist * aged 16 or older * peak pruritus intensity of 4 or more on a 11-point numerical rating scale (0-10, with 10 representing worst itch) * able to engage with a mobile application in the english language exclusion criteria: * patients with active psychiatric symptoms (e.g. active suicidal ideation, psychosis, delusions) * patients with unstable psychiatric condition, characterized by o hospital inpatient admission for a psychiatric condition or initiation of a psychotropic medication in the prior 3 months * patients with unstable dermatological condition, characterized by * recent flare of the skin condition within the last 2 weeks, including diagnosis of a flare by a doctor, use of systemic steroids, oral antibiotics, wet wrap rescue therapy, oral antivirals, or increase in frequency of phototherapy or dose of systemic medications for the dermatological condition within the last 2 weeks or * any of the following within 3 months * inpatient admission for a dermatological condition * initiation of phototherapy * initiation of systemic therapy (conventional immunosuppressive agent, biologics, jak inhibitors) within the last 3 months.

Keywords: digital health eczema psoriasis urticaria healthservices research digital mental health