Kornimate/medical-research-clean huggingface dataset:
preventing and addressing at-obesity-risk early years intervention with home visits in toronto (parent): a pragmatic rct

Conditions: Child Obesity

Summary: the parent trial aims to determine if the parents together program consisting of parent workshops, home visits and coaching calls, will result in better health outcomes for children. the program which is facilitated by a public health nurse seeks to encourage healthy lifestyle, help build strong family relationships, and promote child mental health.

this study will determine whether a primary care based intervention that combines group based parenting skills training and public health nurse home visits with a focus on healthy nutrition, activity and sleep, compared to regular health care will lead to improved weight status in 18 months- 4 year old children. healthy children at risk for obesity will be identified through primary care practices participating in target kids!. families who participate in this study will be randomly assigned (having an equal chance of being in either group) to one of the two study groups that will run for 6-months: group a: receive 8 weeks of group parenting education sessions, 2 additional group sessions, with 2-4 public health nurse home/virtual visits group b: receive regular health care

Eligibility criteria:
inclusion criteria: * children at risk for childhood obesity (meeting any of the risk factors below): * birth weight greater than 3500g * weight gain in first year of life (crossing of at least 1 percentile line of weight for age or weight for length percentile) * maternal or paternal obesity, * gestational smoking at birth * low median household self-reported income * availability of at least one caregiver to participate in trial exclusion criteria: * young children with prader-willi syndrome or severe developmental delays * obesity or severe obesity (defined as zbmi \>2 for all ages) * families not fluent in english * children with a sibling already enrolled in the study * families who reside beyond the toronto public health catchment areas

Keywords: childhood obesity prevention;
self-estimates and objective blood alcohol concentration in emergency department

Conditions: Alcohol Use Disorder; Blood Alcohol Content

Summary: many patients presenting in emergency department (ed) present alcohol acute intoxication. some previous studies in general population found that young people under- or over-estimated of blood alcohol concentration (bac). the hypothesis of the study is that self-estimation of bac by the patient is under-estimated. moreover, comparing self-estimation of bac and objective measure of bac, which is routinely performed in ed, could increase in patients the awareness of the disorders, increase motivation to change of the patient, and increase the rates of seeking-treatment six months after the first evaluation, in particular in patients with alcohol use disorders. to the investigators knowledge, there is no study investigating self-estimation, compared to objective measurement of blood alcohol concentration in patients with alcohol intoxication presenting to an emergency department (ed). the study will assess blood alcohol concentration and self-estimates of bac, using the subjective effects of alcohol scale for measuring subjective response to alcohol in 100 patients with or without alcohol use disorders according to dsm-5 classification (using mini scale and alcohol use disorders identification test (audit)


Eligibility criteria:
inclusion criteria: * patients admitted in emergency department while intoxicated will be included in the study, including patients with or without alcohol use disorders according to dsm-5 classification. * aged 15-64 years old * patients who will be orally informed and receive a written summary * blood alcohol concentration of 60mg/dl or higher * patients not opposed to participating in the study, who have received an oral and written information exclusion criteria: * drug intoxication (cannabis, opiates, amphetamines, cocaine), psychotropic medication intoxication (benzodiazepines, antipsychotics), primary neurologic conditions, mental retardation, dementia, amnestic disorders, mental disorders due to a general, medical condition and substance-induced psychotic disorders.

Keywords: blood alcohol concentration emergency department alcohol use disorders
cross-over study in volunteers to compare the pharmacokinetics of tiotropium delivered from test and reference products

Conditions: Healthy

Summary: the purpose of this study is to compare the absorption of two different inhalation products with the reference product in healthy volunteers.

healthy subjects will be enrolled and will receive single doses of 2 test inhalation products and one reference inhalation product according to a three-period cross-over design. subjects will use the patient instruction leaflet to understand how each inhaler is administered. plasma tiotropium levels will be measured pre-dose and over 8 hours post-dose.

Eligibility criteria:
inclusion criteria: * healthy volunteer * willing and able to give informed consent * willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic * subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration exclusion criteria: * evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders * any presence or history of a clinically significant allergy including any adverse reaction to study drug * history of drug or alcohol abuse within the past 2 years * smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked) * donation or loss of greater than 400 ml of blood within the previous 3 months * have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted) * have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days) * upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months * if female, nursing, lactating or pregnant * regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 ml of 40% spirit or a 125 ml glass of wine)

Keywords: inhalation anticholinergic
efficacy of tranexamic acid in hemoptysis

Conditions: Hemoptysis

Summary: the purpose of study is to evaluate the efficacy of tranexamic acid in controlling bleeding in patients of hemoptysis and also to evaluate the safety of tranexamic acid.

hemoptysis is a common problem in india due to high incidence of tuberculosis and also due to post tubercular sequale. hemoptysis is usually managed conservatively in mild to moderate cases and cases of massive hemoptysis are managed with more definitive treatment options like vessel embolization (bronchial/pulmonary artery) and surgery as a last option. tranexamic acid is a antifibrinolytic used in many surgeries and trauma patients to control bleeding and it has been shown effective and safe. the purpose of the study is to evaluate the efficacy of tranexamic acid in patients with hemoptysis in controlling bleeding.

Eligibility criteria:
inclusion criteria: 1. acute ongoing hemoptysis 2. age: 18 years and above exclusion criteria: 1. pregnant females 2. females on oral contraceptives 3. patients on antifibrinolytics 4. patients with known drug allergy 5. patients with renal failure 6. patients requiring intubation during study period 7. patients with massive hemoptysis (\>600 ml/24 hrs)

Keywords: hemoptysis tranexamic acid vas score
a study to investigate the effect of inhaling a single dose of gw642444m in asthmatic patients

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this study will involve the use of a new compound, gw642444 that is being developed for the treatment of asthma and chronic obstructive pulmonary disease (copd). it works by acting on cells in the lungs, causing some of the muscles around the lungs to relax and open up better (bronchodilation), making breathing easier. when a medicine is made into a form ready to be given to patients, the active ingredient is often prepared with another ingredient called a salt to help make it stable, and inactive ingredients are often added. inactive ingredients might be used to help a medicine work better, to make it easier to produce the medicine, or to make it easier to get an accurate dose of medicine. in previous studies the study drug has been given as a dry powder containing either the "h" salt (with the inactive ingredient lactose), or containing the "m" salt (with the inactive ingredients lactose and cellobiose octaacetate). the "m" salt form of the study drug has been altered to contain lactose and a new inactive ingredient called magnesium stearate (instead of cellobiose octaacetate). participants in this study will receive both the "h" salt (gw642444h) and the new "m" salt (gw642444m) containing magnesium stearate. this study will be the first time the new "m" salt form of the study drug will be given to asthmatic patients.


Eligibility criteria:
inclusion criteria: * male or female (of non-childbearing potential) between 18 - 70 years * history of stable mild to moderate asthma * non - smokers * currently taking daily doses of inhaled fluticasone propionate 200 - 500 mcg (or equivalent) * body weight \>50 kg with bmi 19-29.9 kg/m2 * normal ecg assessment exclusion criteria: * history of significant disease * history of life threatening asthma * recent respiratory tract infection * recent change of asthma medication * treatment with high dose inhaled corticosteroids or oral corticosteroids * recent participation in another trial * history of drug or alcohol abuse * known allergies (excluding asthma) * recent blood donation

Keywords: gw642444, magnesium stearate, asthmatic patients
study to assess en3835 in the treatment of plantar fibromatosis (also known as ledderhose disease)

Conditions: Plantar Fibromatosis; Ledderhose Disease

Summary: this study will assess the efficacy, safety, and tolerability of en3835 compared to placebo in the treatment of pfi (also known as ledderhose disease).


Eligibility criteria:
key inclusion criteria: * be an ambulatory male or female ≥18 years of age. * have a diagnosis of pfi. * have current foot pain due to pfi. * agree not to use prohibited medication, throughout the study, and not use any medication to treat pfi pain, except as permitted per the protocol. * if female, be of non-childbearing potential (history of hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or postmenopausal with no history of menstrual flow in the 12 months prior to the screening visit); or, if of childbearing potential, be non-pregnant, non-lactating and agree to use effective contraception when with a male partner for the duration of the study and for 28 days after any active treatment period. * be capable of providing consent, are adequately informed, and understand the nature and risks of the study. key exclusion criteria: * has the presence of non-pfi-related nodules on the foot (for example, neurofibroma, rhabdomyosarcoma, liposarcoma, neurilemmomas, rheumatoid nodules, desmoid tumors, or malignant soft tissue lesions of the foot or ankle). * has any musculoskeletal, neuromuscular, neurosensory, other neurological or related disorder that affects the participant's use of his or her foot and/or would impair his/her completion of study assessments as determined by the investigator. * has any significant medical history or examination findings related to the participant's plantar nodule(s), which in the investigator's opinion, would make the participant unsuitable for study intervention administration or required assessments and evaluations. * has a known bleeding disorder which would make the participant unsuitable for enrollment in the study. * has a clinically significant laboratory abnormality. * has concurrent diseases that might interfere with the conduct of the study, confound the interpretation of the study results or endanger the participant's well-being, or any significant hematological, endocrine, cardiovascular, respiratory, renal, hepatic, or gastrointestinal disease. if there is a history of such disease but the condition has been stable for greater than 1 year and is judged by the investigator not to interfere with participation in the study, the participant may be included, with the documented approval of the medical monitor. * has any other significant medical condition(s), which in the investigator's opinion, would make the participant unsuitable for enrollment in the study. * is pregnant or plans to become pregnant. * is breastfeeding or is providing or plans to provide breast milk in any manner during the study.
the impact of germanium-embedded knee brace on patient recovery after acl reconstruction

Conditions: Anterior Cruciate Ligament Injuries

Summary: anti-inflammatory brace technology has demonstrated superior clinical outcomes in the management of knee osteoarthritis and accelerate recovery time for major league soccer players. authors have postulated that embedding germanium into cotton garments increases circulation and augments the inflammatory process through a transdermal micro-electromagnetic field. in addition to immunomodulatory effects, knee braces immobilize and stabilize the joint through tactile feedback from the skin. thus, a germanium-embedded knee brace may provide inflammatory control to augment pain and edema while concomitantly enhancing proprioception. acl reconstruction rehabilitation goals during the acute post-operative phase include diminishment of pain and edema as well as restoration of knee range-of-motion. the presented study intends to assess the impact of a germanium-embedded knee brace on patient recovery after acl reconstruction. single-center blinded randomized controlled clinical trial to study effectiveness of germanium-infused knee brace on rehabilitation in patient population undergoing acl reconstruction. patients will be randomized into germanium-infused knee brace group and compared to a replica knee brace group. inclusion criteria will include skeletally mature individuals undergoing primary acl reconstruction. exclusion criteria will include autoimmune disorders and history of surgery on ipsilateral joint. the presented protocol intends to assess the impact of a germanium-embedded knee brace on patient recovery after acl reconstruction. the primary outcome measure was chosen for its implications for the design and conduct of the study,1 including well-validated outcome instrument for comparison, facilitation of a priori power analysis, randomization, and blinding. secondary outcomes were chosen for their pertinence to surgeon decision-making during patient rehabilitation.


Eligibility criteria:
inclusion criteria: * 18-100 years old * male or female * compliant patient * bmi less than 35 * undergoing acl reconstruction within 30 days exclusion criteria: * rheumatoid arthritis * poorly controlled diabetes (hga1c \> 7.5) * previous blood clots * bmi greater than 35 * varicosities on operative leg
study of the effect of exercise training on patients in atrial fibrillation

Conditions: Atrial Fibrillation

Summary: purpose physical exercise is beneficial for patients with ischemic heart disease and chronic heart failure, while little is known about the effect in atrial fibrillation (af). the investigators studied the effect of physical exercise on cardiac output (co), max. exercise capacity, biomarkers and quality of life (qol) in patients with af in a randomised study of physical exercise training three times weekly for twelve weeks. hypothesis exercise training improves cardiac output (co), max. exercise capacity, biomarkers and quality of life (qol) in patients with af. methods assessment of exercise capacity, co, qol, body composition, six minute walk test and muscular strength was performed before and after 12 weeks. resting echocardiography was done at baseline. co was measured using impedance cardiography at rest and during maximal exercise testing on an ergometer bicycle. body composition, muscular strength and six minutes walking capacity were measured before and after the training period. qol was evaluated by the use of the standardized validated questionnaires short form 36 (sf-36) and the minnesota living with heart failure questionnaire (mlhf-q). training consisted of aerobic exercise at 70 percent of max. capacity estimated by borg-scale.


Eligibility criteria:
inclusion criteria: * adult subjects in permanent atrial fibrillation, willing to participate in a 12 weeks training program and able to give informed consent to participation were eligible for the study. exclusion criteria: * subjects with severe refractory hypertension * previous heart valve surgery, moderate to severe copd * restrictive lung disease, moderate to severe asthma * pregnant or lactating subjects * patients with a very low life expectancy * patients who were unable to exercise or comply with the study protocol

Keywords: exercise training atrial fibrillation
self-monitoring of the intraocular pressure versus hospital-based diurnal monitoring

Conditions: Intraocular Pressure

Summary: glaucoma remains the leading cause of irreversible blindness worldwide. glaucoma represents a group of diseases that lead to optic nerve damage and corresponding deterioration of the visual field. elevated intraocular pressure remains the most important risk factor. interestingly, glaucomatous damage sometimes occurs despite seemingly normal intraocular pressure. recent studies suggest pressure peaks, which are missed under the current practice of spot intraocular measurements during office hours. in order to detect pressure peaks diurnal measurements are mandatory. costly in-hospital diurnal measurements are the current standard. the primary study objective is to verify that self-tonometry at home can provide valuable information when looking for pressure peaks in patients with glaucoma.


Eligibility criteria:
inclusion criteria: * informed consent * subjects aged 18 and older * glaucoma patients and healthy controls * best corrected visual acuity \>0.1 * astigmatism ≤ 3dpt. * good compliance * central corneal thickness (400-650μm) * passed certification procedure (detailed description under: measurements and procedures) * therapeutic regimen unchanged throughout the past 30 days exclusion criteria: * history of ocular trauma * corneal condition interfering with tonometry (keratoconus, corneal scaring) visual acuity \<0.1 * physical or mental disability interfering with self-tonometry (e.g. arthritis, parkinson's disease) * dry eye disease * known or suspected non-compliance, drug or alcohol abuse * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * pregnancy * breastfeeding

Keywords: glaucoma self-monitoring intraocular pressure icare home rebound tonometry
ferumoxytol versus oral iron in the treatment of anemia in hemodialysis patients

Conditions: Anemia

Summary: the study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients on hemodialysis.

this study will evaluate the efficacy and safety of intravenous (iv) iron (ferumoxytol) as compared to oral iron in the treatment of anemia in hemodialysis patients receiving erythropoietin. patients are randomized to receive either two doses of 510 mg of intravenous ferumoxytol in sequential dialysis sessions or 200 mg oral elemental iron daily for three weeks.

Eligibility criteria:
inclusion criteria: * male or female patients ≥18 years. * chronic hemodialysis. * stable supplemental epo therapy. * baseline hemoglobin of ≤ 11.5 g/dl. exclusion criteria: * women who are pregnant or who are breast feeding. * received another investigational drug or device within 30 days. * recent parenteral or oral iron therapy. * patients with active gi bleeding or acute bleeding within 4 weeks. patients that have other causes of anemia. * major surgery within 30 days or anticipated or planned surgery during the study. * patients with active infections. * recent blood transfusions. * patients with known allergies to iron products.

Keywords: anemia iron
observational study in patients with nail psoriasis treated with enstilar® to assess the severity change and the quality of life

Conditions: Nail Psoriasis

Summary: observational, prospective and multicentre study to evaluate the effectiveness of calcipotriene and betamethasone dipropionate aerosol foam (cal / bd), prescribed according to clinical practice and following the product data sheet instructions, in the topical treatment of nail psoriasis according to the change in the score of the nail psoriasis severity index (napsi) at 12 weeks of treatment with respect to the initial score.


Eligibility criteria:
inclusion criteria: * patients with nail psoriasis who start, according to clinical practice, topical treatment with calcipotriene and betamethasone dipropionate aerosol foam * patients who authorize their participation in the study by signing written informed consent. exclusion criteria: * patients receiving treatment with systemic drugs or their prescription is scheduled for the next 3 months. however, may be included patients who receive the same systemic treatment regimen from at least 6 months before their inclusion in the study and up to 14 weeks later. * patients with any situation or state that in the opinion of the investigator discourages their participation in the study.