Kornimate/medical-research-clean huggingface dataset:
a study to look at day to day changes in lung function in copd subjects taking albuterol/salbutamol and ipratropium

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the objective of this study is to assess the daily variation in bronchodilator response to an inhaled short acting beta2-agonist (albuterol/salbutamol) and an inhaled short acting anticholinergic (ipratropium) individually and when used in combination in subjects with copd.

beta2-agonist and anticholinergics are a principle component of the pharmacologic management of chronic obstructive pulmonary disease copd. it has been demonstrated that the combination of a short acting beta2-agonist and a short acting anticholinergic yields greater efficacy as measured by fev1 when compared with the response to the individual short acting bronchodilators. however, daily bronchial response to these agents is poorly understood. it is also poorly understood how the variation in magnitude of the response to the individual agents and how the variation in response for one agent coincides with the variation in response to the other agent. this study will seek to define the pattern of response of each individual agent and the relationship between them. the study will also explore if the combination of the two agents leads to less variation in response compared to the individual agents. this is a randomized, open label, two period cross-over study. eligible subjects will be randomized to a sequence of either albuterol/salbutamol via metered-dose inhaler (mdi) followed by ipratropium via mdi or the same dose of each bronchodilator given in the opposite order. each study period will consist of 10 clinic visits to be conducted over 10 to 14 days.

Eligibility criteria:
inclusion criteria: * subjects must give their signed and dated written informed consent to participate. * subjects 40 years of age or older at visit 1. * male or female subjects . * an established clinical history of copd. * current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years at visit 1. * a post-albuterol/salbutamol fev1/fvc ratio of \ =30 and \<= 70% of predicted normal values at visit 1 calculated using nhanes iii reference equations . exclusion criteria: * a current diagnosis of asthma * women who are pregnant of lactating or are planning on becoming pregnant during the study. * hospitalization for copd or pneumonia within 12 weeks prior to visit 1. * participation in pulmonary rehabilitation
the effect of bolus speed of rapid-acting insulin analog absorption and action in individuals with type 1 diabetes

Conditions: Type1diabetes

Summary: rapid action insulin (rai) absorption and action measured by time to reach maximum insulin concentration and glucose infusion rate.

the investigators hypothesize that rai absorption and action measured by time to reach maximum insulin concentration and glucose infusion rate during the clamp study will be significantly faster when insulin bolus is delivered using the "quick bolus" feature as compared to the "standard bolus". outcomes were updated at time of results entry.

Eligibility criteria:
inclusion criteria: 1. age 18 - 30 (inclusive) 2. clinical diagnosis of t1d of at least one year's duration 3. on continuous subcutaneous insulin infusion (csii) therapy for at least three months 4. hba1c \<10% 5. minimum weight requirement of at least 37.9 kg 6. ability to comprehend written and spoken english 7. total daily requirement of insulin between 0.6 and1.2 u/kg/day 8. not have any other medical condition or disease known to affect insulin action and glucose control aside from t1d or treated hypothyroidism exclusion criteria: 1. medication besides insulin known to alter blood glucose or insulin action 2. female subjects of reproductive potential that are pregnant or breast feeding, or not consistently using a barrier method or abstinence as contraception. 3. inability to comprehend written and spoken english 4. any other condition, which in the judgment of the investigators, would interfere with the subject's ability to provide informed consent or the investigator's ability to perform the study 5. hematocrit less than 35% or a serum potassium less than 3.4 mmol/l
maxillary molar distalization supported by mini-implants with the advanced molar distalization appliance (amda®)

Conditions: Angle Class II

Summary: the aim of this randomized controlled clinical trial is to evaluate the dentoalveolar and skeletal treatment effects of the amda when used for distalization of the maxillary first molars in patients with class ii malocclusion in the permanent dentition.

the primary aim is to evaluate two different treatment groups from initiation of treatment up until completion of maxillary molar distalization of: * group i: patients treated with amda® * group ii: patients treated with buccal mini-implants more specifically to evaluate the efficiency of the amda using lateral cephalograms and digital 3d model casts of the patients under investigation at the following time points: * point t0: baseline data - before initiation of the treatment * point t1: immediately after distalization (8-12 months)

Eligibility criteria:
inclusion criteria: * all patients to have permanent dentition * with or without the 2nd molar erupted * bilateral class ii molar relationships (a quarter to 1 molar cusp). exclusion criteria: * past orthodontic treatment * crossbites, * severe carious lesions, * poor oral hygiene, * mobility of the maxillary first molars, * anterior open bites, * vertical growth pattern, * tongue habits.

Keywords: amda® maxillary molar distalization randomized controlled trial orthodontics
ultrasound assessment of bc in the nicu

Conditions: Premature Infant

Summary: the overall objective of the proposal is to evaluate the ability of ultrasound to predict and routinely (weekly) monitor changes in the body composition of healthy preterm infants in the neonatal intensive care unit (nicu) in response to nutritional intake. the investigators hypothesize that ultrasound is an accurate method to routinely monitor the quality of weight gain and assess the adequacy of nutritional provision for premature infants in the neonatal intensive care unit. the investigators will address the hypothesis in the following specific aims: specific aim 1: validate ultrasound as a method to measure whole body fat mass and fat free mass in healthy, premature infants. body composition will be assessed using ultrasound measurements and the validated method of air displacement plethysmography (adp). stable isotope dilution techniques will be used in a subset of our population as a secondary source of validation. specific aim 2: determine whether ultrasound measurements can detect clinically relevant (weekly) changes in body composition in healthy premature infants. ultrasound will be used to obtain serial (weekly) measurements of muscle and adipose tissue thickness (triceps, abdomen, quadriceps) until discharge in healthy, premature infants.


Eligibility criteria:
inclusion criteria: * healthy, premature infants 25-34+6 weeks gestational age at birth * admitted to the university of minnesota masonic children's hospital nicu * stable on room air or can be removed from respiratory support for 5 minutes * written or verbal (telephone) informed consent can be secured from a parent within 1 week of admission to the nicu exclusion criteria: -require medical support preventing adp measurements
a study to evaluate the efficacy and safety of hb0017 in patients with moderate to severe plaque psoriasis

Conditions: Plaque Psoriasis

Summary: this is a randomized, double-blind, placebo-controlled, multi-center phase 2 study to evaluate the efficacy and safety of hb0017 in subjects with moderate to severe plaque psoriasis.

this is a randomized, double-blind, placebo-controlled, multi-center phase 2 study to evaluate the efficacy and safety of hb0017 in subjects with moderate to severe plaque psoriasis. the study will consist of 3 periods: up to 5 weeks screening period, 28 weeks treatment period, 8 weeks safety follow-up period.

Eligibility criteria:
inclusion criteria: * subject has provided informed consent * diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months prior to screening * psoriasis area and severity index(pasi)\>=12 and body surface area(bsa) \>=10% and static physician's global assessment (spga) score 3 or greater on a 5-point scale * candidates for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy * women who are at childbearing age(not pregnant or breast-feeding), and subjects and their partners voluntarily use contraceptive methods deemed effective by the investigator during treatment and for at least 6 months after the last study medication key exclusion criteria: * forms of psoriasis other than chronic plaque psoriasis. * history or evidence of active tuberculosis, patients with evidence of latent tuberculosis may enter the trial after sufficient treatment according to protocol. * positive results of confirmatory serology test for hepatitis b, hepatitis c, hiv or syphilis at screening. * history of a serious or systemic infection within 4 weeks before screening. * history of malignancy of any organ system within the past 5 years. * inadequate washout period for prior drug therapy. * previous use of secukinumab, ixekizumab or any other drug that targets interleukin 17( il-17) or il-17 receptor. * any medical conditions, in the opinion of the investigator or the sponsor's medical monitor, would place the subject at risk, interfere with study participation or study results interpretation.

Keywords: hb0017 chronic plaque psoriasis
exercise as treatment for patients with inclusion body myositis

Conditions: Inclusion Body Myositis (IBM); Feasibility Study

Summary: there is little knowledge about exercise for patients with inclusion body myositis (ibm). patients with ibm have limited access to rehabilitation and physiotherapy resources, despite a significant need for these services due to the progressive nature of the condition, which leads to a gradual decline in physical function. the purpose of the project is to develop and implement a 16-week exercise intervention at oslo university hospital (ous) for patients with ibm living in oslo and the surrounding area. the exercise sessions will take place once a week at ous, under the guidance of physiotherapists with extensive clinical experience with this patient group. patients are encouraged to exercise at home at least once a week between sessions at ous to achieve sufficient amount of exercise that normally will improve physical fitness. the feasibility and benefits of the exercise intervention will be evaluated using various methods, such as focus group interviews, physical tests, and questionnaires. the study will also provide valuable insight into whether exercise can lead to improvements in muscle strength, fitness, and balance in patients with ibm.


Eligibility criteria:
inclusion criteria * ibm diagnosis * able to walk with aids exclusion criteria -unable to understand and write norwegian

Keywords: exercise feasibility study
aries for vasculogenic erectile dysfunction

Conditions: Erectile Dysfunction; Sexual Dysfunction, Physiological

Summary: this study aims to evaluate the safety and efficacy of low-intensity extracorporeal shock wave therapy utilizing the dornier aries in the treatment of erectile dysfunction of vasculogenic origin.

an increasing number of men are suffering from the effects of erectile dysfunction (ed) each year. the development of oral therapies (phosphodiesterase 5 inhibitors) has been successful for many with the disease. however, these drugs may be contraindicated in patients with cardiovascular risk factors (which are often predecessors to developing ed) and are often ineffective in patients with other comorbid conditions, such as diabetes mellitus. the main objective of this study is to determine the safety and efficacy of low-intensity extracorporeal shock wave therapy using the dornier aries in the treatment of erectile dysfunction of vasculogenic origin. this protocol allows for treatment of 23 men with 21-75 years of age with vasculogenic erectile dysfunction of at least 6 months' duration with low intensity extracorporeal shock wave therapy utilizing the dornier aries device. this protocol includes the application of 5000 shockwaves per session in 5 treatment areas with 1000 sw each at energy level 4-5 (energy flux density (0.051-0.062 mj/mm²), while moving the applicator along the penile shaft within the treatment areas. the maximum energy applied during this treatment would be 23.35j. conversely, the treatment protocol described within is designed to actually restore penile function as a disease-modifying therapy, and is not expected to require a maintenance regimen or continued treatments, as previous studies have demonstrated retained benefits at six months after the end of treatments. dornier medtech hired an independent party to monitor data and perform internal audits to ensure the precision, quality, and integrity of the data collected. the investigator(s) agrees to permit access to study records, source data, and source documents for this purpose.

Eligibility criteria:
inclusion criteria: * age 21 - 75 years * presence of erectile dysfunction for at least 6 months * having some response to a pde5i or injection therapy (ici) without penile scarring * vasculogenic ed * iief-ed score ≥11 up to ≤25 while taking pde5i or on ici * in a stable heterosexual relationship of more than three months' duration * agree to suspend all ed therapy for duration of study * agree to maintain their normal sexual habits * consent to participate exclusion criteria: * radical prostatectomy * previous radiation therapy to pelvis * previous stem cell or platelet rich plasma therapy * previous pelvic surgeries * untreated hypogonadism or thyroid disease * hormone usage, other than testosterone, clomiphene or thyroid medication * illicit drug usage as demonstrated in the drug screen * psychogenic ed * peyronie's disease or penile curvature that negatively influences sexual activity * current anticoagulation therapy or significant hematological conditions

Keywords: shockwave vascular ed organic ed
t-wave alternans and intrathoracic impedance measurements

Conditions: Congestive Heart Failure; Arrhythmias

Summary: t-wave alternans is a test that is currently being used to risk stratify patients with structural heart disease for sudden cardiac death. the mechanism of t-wave alternans is unclear, but may share a common abnormality with conditions of cardiac fluid overload such as heart failure, which is altered intracellular calcium handling. current medtronic implantable defibrillators have the capability of monitoring cardiac fluid status via transthoracic impedance measurements. the purpose of this study is to determine if a correlation exists between t-wave alternans status and cardiac volume status, as determined by transthoracic impedance measurements. secondarily, the study seeks to examine the relationship between arrhythmia frequency and t-wave alternans or cardiac volume status.


Eligibility criteria:
inclusion criteria: * class iii or iv heart failure patients with a chronically implanted medtronic biventricular defibrillator system capable of monitoring intrathoracic fluid volume. exclusion criteria: * no active ischemia or pulmonary edema, atrial fibrillation, complete heart block
the influence of eccentric training on the volume and vascularisation of the rotator cuff in patients with rotator cuff tendinopathy and healthy subjects

Conditions: Rotator Cuff Tendinopathy

Summary: patients with rotator cuff tendinopathy make up a large part of the population in physiotherapy practice. the rotator cuff, a shoulder muscle group, plays an important role in causing pain. tendons suffer large compression and friction, which can lead to degeneration of these tendons. rehabilitation often leads to unsatisfying results. in achilles and patella tendinopathy, a new training program called eccentric training has shown very good results. eccentric training contains exercises during which a force has to be resisted while the muscle lengthens instead of shortens. this would have a larger influence on tendon tissue. some small studies also show promising results of eccentric training in patients with rotator cuff tendinopathy but the mechanisms behind these results remain unclear. to investigate this, 30 patients with rotator cuff tendinopathy and 30 healthy subjects will be evaluated before and immediately after performing the exercise. three measurements will be done: ultrasonographic measurement of tendon thickness, power doppler imaging and measurement of microcirculation around the tendon with oxygen to see. all measurements are non-invasive, pain free and without risks for the human body.


Eligibility criteria:
inclusion criteria patients: * male/ female * 18-40 years old * unilateral shoulder pain for at least 3 months * pain of at least 3/10 on a visual analogue scale * painful arc or pain at end range abduction * 2/3 impingement tests positive * 2/4 resistance tests positive * pain at insertion rotator cuff exclusion criteria patients: * spurling test positive * shoulder surgery in the past * osteoarthritis shoulder * full thickness ruptures inclusion criteria healthy subjects: * male/ female * 18-40 years old exclusion criteria healthy subjects: * shoulder pain during the last 3 months * shoulder surgery in the past * neck pain or disability * systemic disease (e.g. marfan, ehlers danlos,...)
omegaven as alternative parenteral fat nutrition

Conditions: Cholestasis; Cholestasis of Parenteral Nutrition

Summary: to provide omegaven® as a compassionate treatment for critically ill infants with parenteral nutrition associated cholestasis

an intermediate population, investigational new drug study, to provide an alternate intravenous fat nutrition, omegaven®, to help improve liver function while providing adequate nutrition for critically ill infants with parenteral nutrition associated cholestasis

Eligibility criteria:
inclusion criteria: * greater than 14 days old * has parenteral nutrition associated cholestasis defined as at least 2 consecutive direct bilirubin \>2 mg/dl with anatomical or functional short gut (or \>4 mg/dl if intact intestine) obtained at least 1 week apart with a ratio of direct: total bilirubin \> 0.4 * patient is parenteral nutrition dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require parenteral nutrition for at least 3 more weeks * patient has not responded to other therapeutic approaches for parenteral nutrition-associated liver disease such as : cycling of parenteral nutrition, avoiding overfeeding, reduction/removal of copper and manganese from parenteral nutrition, advancement of enteral feeding, and use of ursodiol * patient has been on at least 2 weeks of smoflipids with no improvement or worsening of direct bilirubin levels * signed patient informed consent * the patient is expected to have a reasonable possibility of survival * no other known etiology of cholestasis other than parenteral nutrition-associated liver disease at the time of omegaven® initiation exclusion criteria: * known causes of cholestasis other than parenteral nutrition-associated liver disease including but not limited to hepatitis c, cystic fibrosis, biliary atresia, and alpha 1 antitrypsin deficiency are present, prior to omegaven® initiation * known fish or egg allergy * any of the contraindications to use of omegaven®: 1. active new infection at the time of initiation of omegaven® 2. hemodynamic instability 3. recent use of medications with associated risk of bleeding, including nsaids 4. active coagulopathy or bleeding 5. platelet counts persistently under 30,000 despite transfusions 6. unstable hyperglycemia 7. impaired lipid metabolism (triglycerides \>1000 mg/dl) while on 1 g/kg/day or less of intralipid 8. history of severe hemorrhagic disorders (ie. hemophilia, von willebrand disease, etc.) 9. unstable diabetes mellitus 10. collapse and shock 11. stroke/ embolism 12. cardiac infarction within the last 3 months 13. undefined coma status

Keywords: omegaven parenteral nutrition liver disease cholestasis
parkinwalk: physical activity and long group-walking for parkinson's disease

Conditions: Parkinson Disease; Healthy Aging

Summary: the study will evaluate the impact of exercise training program followed by long-walking onon supervised and unsupervised gait assessment in parkinson´s disease and control subjects.

background: several studies suggest an impact of physical exercise on walking parameters in parkinson´s disease (pd) patients. objective: the present study will evaluate the impact of three months physical exercise training program followed by a group-long walking on motor impairment in pd. methods: pd patients will be randomized in two arms: one group will be assessed to a training exercise program of three months followed by long-walking in group under the support of physician/physiotherapist and caregivers. a complete motor, cognitive and general assessment will be performed at baseline. the patients will be evaluated under supervised an unsupervised conditions at baseline, before the long-walking, during the walking and after 2 months after the walk.

Eligibility criteria:
inclusion criteria: * parkinson´s disease diagnosis * stable dopaminergic treatment ( stable dose in the last three months before baseline evaluation) exclusion criteria: * gait impairment due to other medical conditions * dementia * impulsive compulsive disorder * severe depression
using a smartphone app to target current mental health symptoms of anxiety and depression

Conditions: Depression; Anxiety; Cancer

Summary: this is a prevention intervention study that will examine the efficacy of a smartphone-based intervention in decreasing cancer risk by targeting mental health risk factors of anxiety and depression.

this prevention intervention study aims to examine the efficacy of a smartphone-based intervention in decreasing cancer risk by targeting mental health risk factors of anxiety and depression. the study will utilize a smartphone application called mood triggers, designed to provide personalized feedback on individuals' maintenance factors (i.e., "triggers") of their anxiety and depressive symptoms. mood triggers delivers ultra-brief interventions (less than 2 minutes long) where participants view videos introducing important skills to treat their anxiety and depression. the study targets middle-aged adults (40-64 years old) who meet current criteria for moderate to severe anxiety and/or depressive disorders. it will enroll an anticipated 100 participants in a single-group, open-label design, with the intervention lasting up to 12 weeks. the primary outcomes include changes in depression and anxiety symptoms, measured by the patient health questionnaire-9 and the generalized anxiety disorder-q-iv scale, respectively, as well as changes in cancer risk assessed by the world cancer research fund/american institute for cancer research cancer prevention score.

Eligibility criteria:
inclusion criteria: 1. middle-aged adults (age 40 to 64). 2. fluent in english. 3. able to provide informed consent. 4. meets current criteria for an anxiety and/or depressive disorder with severity ranging from moderate to severe (based on the patient health questionnaire - 9 and the generalized anxiety disorder questionnaire). 5. owns a smartphone. exclusion criteria: 1. acute psychosis (based on the self-reported structured interview for psychosis risk syndromes, prodromal questionnaire - brief version \[sips pq-b\]). 2. moderate to high suicidal ideation (based on a response of 2 or more on the phq-9 item-9). 3. history of bipolar disorder (based on the self-reported mood disorder questionnaire \[mdq\]. 4. past or current diagnoses of cancer. 5. changes to treatments or medications in the past 30 days.

Keywords: cancer prevention passive sensing