Kornimate/medical-research-clean huggingface dataset:
bronchodilatation effects of a small volume spacer used with a metered-dose inhaler

Conditions: Asthma

Summary: the purpose of the present study is to determine whether use of a small volume spacer is associated with better bronchodilatation in an unselected population of patients with documented reversible airflow limitations.

administration of bronchodilator drugs with metered-dose inhalers (mdis) is difficult for some patients because the timing of the spray and the inhalation must be coordinated exactly. use of spacers seems to improve delivery in these patients. it is not clear, however, if there is any advantage to a spacer for patients who are able to use an mdi with correct technique. the purpose of the present study is to determine whether use of a small volume spacer is associated with better bronchodilatation in an unselected population of patients with documented reversible airflow limitations. the intervention in the first part of the study is use of an mdi with or without a spacer to deliver a bronchodilator (2 puffs, 0.4 mg of fenoterol). spirometry is performed before and after the inhalation. the second part of the study is conducted identically to the first with the same conditions and variables but with the addition of rinsing the mouth with 100 ml of water after inhaling the bronchodilator but before the second spirometry measurement. the outcome to be measured is the increase in forced expiratory volume in 1 second (fev1) and forced expiratory flow rate (fef25-75%).

Eligibility criteria:
inclusion criteria: * age \> 6 years old, * subjects known to have reversible airway limitation with demonstrated response to bronchodilators on spirometry. exclusion criteria: * refusal to participate, * negative bronchodilator test, * poor performance of pulmonary function testing.

Keywords: metered-dose inhalers (mdi) forced expiratory volume in 1 second (fev1) forced expiratory flow rate (fef25-75%)
safety and efficacy of thymic peptides in the treatment of hospitalized covid-19 patients in honduras

Conditions: COVID-19

Summary: this is a single-arm, open-label, phase ii clinical study to evaluate the safety and efficacy of thymic peptides in the treatment of hospitalized covid-19 patients in honduras.

this study was approved and registered by the dirección general de vigilancia del marco normativo de la secretaría de salud de honduras (general directorate for regulatory framework surveillance of the ministry of health of honduras) the eight of february of 2021; enrollment began tenth of february of 2021. the study will analyze 23 clinical parameters, 9 laboratory studies besides complete blood count, chest radiography, time to response, adverse clinical outcomes, and hospital length of stay in 22 participants treated with a daily oral dose of 250 mg of lyophilized thymic peptides dissolved in 50 ml of water (one hour before or two hours after a meal) in addition to the standard treatment. a participant-level comparison based on registry data from hospital de santa bárbara integrado will be performed after propensity score matching. the generic assessment of side effects in clinical trials (gase) will be applied in addition to monitoring of treatment-emergent adverse events.

Eligibility criteria:
inclusion criteria: * confirmed case of covid-19 by viral nucleic acid (rna) detection, viral antigen detection, or detection of antibodies to the virus. * participants that require hospitalization under honduran ministry of health guidelines for clinical management of covid-19 adult patients: stage iib, defined as a patient with or without risk factors that presents with warning signs (shortness of breath, tachypnea), and altered inflammatory parameters. * participants that present with at least one of the following: oxygen saturation level below 94 percent; complete blood count showing lymphopenia, neutrophilia, or both; positive c-reactive protein; chest radiography or ct scan with ground-glass opacities. * male or female at least 21 years old. exclusion criteria: * covid-19 patients that do not require hospitalization under honduran ministry of health guidelines for clinical management of covid-19 adult patients: phase ia (asymptomatic), phase ib (mild symptoms without risk factors), or phase ic (mild symptoms with risk factors). * participants currently in other clinical trials evaluating experimental drugs. * known history of allergic reactions to thymic peptides or calf thymus acid lysate derivatives. * organ transplant recipients. * women who are pregnant or breast feeding.

Keywords: sars-cov-2 infection covid-19 pandemic 2019 novel coronavirus disease thymic peptides thymus gland peptides honduras coronavirus disease 2019 coronavirus disease-19 covid-19 virus infection 2019-ncov disease 2019-ncov infection
desyne in routine clinical practice

Conditions: Angioplasty, Transluminal, Percutaneous Coronary; Coronary Artery Disease

Summary: the purpose of this study is to evaluate effectiveness and safety of desyne in routine clinical practice


Eligibility criteria:
inclusion criteria: * age 20 and more * intervention with desyne drug eluting coronary stent * agreed with written informed consent form exclusion criteria: * intervention with desyne drug eluting coronary stent and other drug eluting stent at the same time * life expectancy of 1year and under * cardiac shock

Keywords: desyne angioplasty, transluminal, percutaneous coronary coronary artery disease
toleromune ragweed exposure chamber study

Conditions: Ragweed Allergy

Summary: it is believe that ragweed is the primary cause of autumn allergies and 87% of patients with ragweed allergy suffer rhinoconjunctivitis. toleromune ragweed is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of ragweed allergy. this study will look at the efficacy, safety and tolerability of two doses of toleromune ragweed in ragweed allergic subjects following challenge with ragweed in an eec.

this study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of toleromune ragweed in ragweed allergic subjects with allergic rhinoconjunctivitis,subjects may also have controlled asthma. the efficacy of toleromune ragweed will be explored in subjects using an(environmental exposure chamber)eec. the study will consist of 3 study periods. in period 1, screening will be performed up to a maximum of 12 weeks before randomisation and may consist of one or two visits to the clinic, at the investigator's discretion. baseline challenge will consist of 4 visits to the eec at least 3 days before randomisation. in period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of five groups and will receive treatment every 2 weeks (±2 days) for 14 weeks. in period 3, post treatment challenge will consist of 4 visits to the eec 18-22 weeks after the first administration in the treatment period and assessments will be performed identical to those at the baseline challenge. follow-up will be conducted 3-10 days after ptc.

Eligibility criteria:
inclusion criteria * male or female, aged 18-65 years. * minimum 2-year documented history of rhinoconjunctivitis on exposure to ragweed. \[subjects may also have controlled asthma * positive skin prick test to ragweed allergen. * minimum qualifying rhinoconjunctivitis symptom scores exclusion criteria * history of asthma. * a history of anaphylaxis to ragweed allergen. * subjects with an fev1 \<70% of predicted. * subjects who cannot tolerate baseline challenge in the eec. * subjects for whom administration of epinephrine is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension). * a history of severe drug allergy, severe angioedema or anaphylactic reaction to food. * a history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment).

Keywords: ragweed allergy rhinoconjunctivitis exposure chamber immunotherapy toleromune ragweed
levetiracetam treatment of tardive dyskinesia

Conditions: Tardive Dyskinesia

Summary: this is a placebo-controlled study designed to learn if levetiracetam is effective for tardive dyskinesia.


Eligibility criteria:
inclusion criteria: meet glazer morgenstern criteria for td - exclusion criteria: none -
safety and efficacy of doses of leo 43204 once daily for two consecutive days on full balding scalp in subjects with actinic keratosis

Conditions: Actinic Keratosis

Summary: to identify the maximum tolerated dose levels of leo 43204 after once daily treatment for two consecutive days and to evaluate efficacy of leo 43204 in two doses after once daily treatment for two consecutive days compared to vehicle


Eligibility criteria:
inclusion criteria: * part 1: subjects with 5 to 20 clinically typical, visible and discrete aks on the full balding scalp. * part 2: subjects with 5 to 20 clinically typical, visible and discrete aks on the full balding scalp exclusion criteria: * location of the treatment area * within 5 cm of an incompletely healed wound * within 5 cm of a suspected basal cell carcinoma (bcc) or squamous cell carcinoma (scc) * prior treatment with ingenol mebutate gel on the treatment area * lesions in the treatment areas that have * atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or * recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)
traumeel s in reducing pain after correction of hallux valgus-clinical trial

Conditions: Post Hallux Valgus Repair Pain

Summary: hallux valgus is a common deformity of the big toe, defined as medial deflection of the first metatarsal bone along with lateral deflection of the first toe. surgery has been shown to be beneficial when compared to orthoses or no treatment. while generally effective, surgery entails significant post-operative pain, inflammation and edema, and several weeks of limited mobility. this will be a double-blind, randomized, placebo-controlled study comparing the homeopathic drug traumeel s with placebo in pain reduction after surgical hallux valgus correction. 80 patients, over the age of 18 years, undergoing surgical correction of unilateral hallux valgus will be enrolled in the trial. the patients will be randomized to two groups, one receiving oral traumeel s and the other oral placebo tablets. patients will take active or placebo medication for 13 days or until they have a nrs score of 3 or less for 2 consecutive days. pain will be reported daily by the patient on the patient diary, using an 11-point numerical rating score (nrs-11) during 13 days post-operatively. they will also be asked to report daily consumption of primary and "rescue" analgesics for 13 days post-operatively. patients will be contacted daily by the research assistant to encourage compliance and to record their daily nrs and analgesic consumption in the crf. patients will be evaluated by physicians at six and 13 days postoperatively for redness and compliance.


Eligibility criteria:
inclusion criteria: patients of either sex undergoing unilateral surgical correction of hallux valgus. age over 18 years. signature upon informed consent form. meeting none of exclusion criteria. exclusion criteria participation in another clinical trial within 4 weeks prior to enrollment. inability to comply with the study protocol. previous surgical hallux valgus correction on ipsilateral foot. current use of analgesia for any other reason.

Keywords: homeopathy hallux valgus pain traumeel s
effect of hydration guided by vigileo on the prevention of cin after pci for patients with ami

Conditions: Myocardial Infarction; Contrast-induced Nephropathy

Summary: in this study, vigileo is used to guide hydration adjustment, and scr is used to estimate renal function. the aim of the study is to investigate the preventive effect of adequate hydration guided by vigileo on contrast induced nephropathy in patients with acute myocardial infarction who undergo pci.

this study was conducted in patients with acute myocardial infarction who undergo emergency pci in chinese pla general hospital. the patients were randomly divided into two groups: the adequate hydration group guided by vigileo and control group. for the adequate hydration group guided by vigileo, vigileo equipment is used to perform hemodynamic monitoring through the femoral or radial arteries to obtain relevant hemodynamic parameters (co, sv, svv), and the fluid-rehydration velocity of normal saline is adjusted according to the hemodynamic parameters, and the hydration also lasts 24 hours after operation. for the control group, the routine hydration regimen is adopted, perioperative saline ≤500 ml hydration. the changes of renal function (serum creatinine, serum cystatin), symptoms and signs of cardiac insufficiency during perioperative period and cardiac objective indexes are observed. the incidence of postoperative acute pulmonary edema is recorded, and the major cardiovascular events and hemodialysis events are followed up for 6 months. by comparing the perioperative indexes of heart and kidney function between the intervention group and the control group, the preventive effect of adequate hydration guided by vigileo on contrast induced nephropathy after pci was clarified.

Eligibility criteria:
inclusion criteria: * clearly diagnosed stemi or nstemi patients: * patients aged 18-80 years * patients are scheduled to undergo emergency percutaneous coronary interventions * estimated glomerular filtration rate egfr \<120ml / min (according to mdrd formula) * sign the informed consent to join the group. exclusion criteria: * patients with mechanical complications * patients with cardiogenic shock * patients with aortic dissection * patients who have malignant tumors or short-term progressive diseases that researchers believe improper to be included in the group * hemodialysis-dependent patients with end-stage renal failure * patients who had a history of exposure to radioactive contrast media within 1 week before or 72 hours after direct pci * patients who are allergic to radioactive contrast agents * patients diagnosed with right ventricular myocardial infarction with hypotension (defined as systolic blood pressure ≤90 mmhg) on admission.

Keywords: hydration contrast-induced nephropathy contrast induced acute kidney injury
comparison of choosing free alt or free pmt for reconstruction with head and neck cancer

Conditions: Reconstructive Surgery; Head and Neck Cancer

Summary: this study was designed to compare the outcome of the anteromedial thigh (amt) and anterolateral thigh (alt) flaps in head and neck cancer reconstruction.

to compare the results of the amt and alt flaps, this study aimed to compare their outcomes in head and neck cancer reconstruction under the condition of attenuating baseline patient and operative characteristics with the selection of propensity score-matched patient cohorts.

Eligibility criteria:
inclusion criteria: * patients who underwent alt or amt free flap reconstruction after head and neck cancer surgery between march 1, 2008 and february 28, 2017. exclusion criteria: * patients whose data were missing will be excluded.

Keywords: anterolateral thigh (alt) anteromedial thigh (amt) free flap reconstruction microsurgery head and neck cancer outcomes
medical and health economic benefit of oral nutritional supplements (ons) in ambulant patients

Conditions: Malnutrition

Summary: the aim of this study is to assess the benefit of a 3-month intervention with oral nutritional supplements (ons) in older ambulant patients with reference to functional limitations and quality of life as well as the consumption of health care resources.

study participants are assessed upon discharge from the hospital and again after 3 months. upon discharge all patients receive nutrition counselling with special focus on an energy rich diet. additionally, the intervention group receives ons. the investigators hypothesize an improvement in functional limitations and health economic benefits due to the post-hospital nutritional intervention.

Eligibility criteria:
inclusion criteria: * age ≥ 60 years * informed written consent * independent community dwelling after discharge * existing or risk of malnutrition * normal cognitive status according to mini-mental state examination (mmse ≥ 24 points) * life expectancy of \> 3 months according to treating doctor * no severe heart disease (new york heart association (nyha) functional classification of 3+), liver disease (child pugh score = a, b) or kidney insufficiency (glomerular filtration rate \< 30 ml/min) * no chemo or radiation therapy * no derailed diabetes mellitus or metabolic decompensation exclusion criteria: * age \< 60 years * lack of informed written consent * dependent living conditions after discharge * no risk of malnutrition * low cognitive status according to mini-mental state examination (mmse \< 24 points) * life expectancy of \< 3 months according to treating doctor * severe heart disease (new york heart association (nyha) functional classification of 3+), liver disease (child pugh score = c) or kidney insufficiency (glomerular filtration rate \< 30 ml/min) * chemo or radiation therapy * derailed diabetes mellitus or metabolic decompensation

Keywords: malnutrition geriatrics enteral nutrition
efficacy of mental health self-directed care financing

Conditions: Mental Illness Persistent

Summary: self-directed care (sdc) programs give people with disabilities control over public funds to purchase traditional behavioral health and non-traditional services in order to remain outside of institutional settings. the purpose of this study is to determine the effects of this model on participant outcomes, service costs, and user satisfaction among people with serious mental illness.

self-directed care (sdc) programs give people with disabilities control over public funds to purchase traditional behavioral health and non-traditional services in order to remain outside of institutional settings. the purpose of this study is to determine the effects of this model on participant outcomes, service costs, and user satisfaction among people with serious mental illness. adults with serious mental illness served in the texas public health system will be randomly assigned to sdc versus services as usual and assessed at baseline, 12-month, and 24-month follow-up. mixed effects random-regression analysis will test for longitudinal changes in outcomes between the two study conditions. differences in service costs will be analyzed using generalized linear models with negative binomial and zero-inflated negative binomial distribution. non-traditional expenditures by the sdc participants will be examined descriptively. service satisfaction in both study conditions will be assessed at one- and two-year follow-up.

Eligibility criteria:
inclusion criteria: * receiving mental health services at a texas department of state health services-funded mental health program * diagnosis of serious mental illness consistent with federal public law 102-32 * assigned to a level of care eligible for a package of comprehensive clinical and rehabilitation services known as service package 3 * 18 years or older * able to understand spoken english. exclusion criteria: * cognitive impairment * homeless at time of recruitment * history of violent behavior resulting in arrest and conviction in the past 10 years * active substance use in the absence of substance use treatment * enrollment in medicare or dual beneficiary * finances controlled by a third party (e.g., representative payee)

Keywords: self-directed care mental health services mental health recovery behavioral health service financing
a prospective clinical study of phenylketonuria (pku)

Conditions: Phenylketonurias

Summary: this is a study for adults and children ≥ 14 years old who have phenylketonuria (pku) with uncontrolled plasma phe levels. no clinical intervention or study drug is provided by biomarin in this study.


Eligibility criteria:
inclusion criteria: * male and female subjects with diagnosis of pku which is a condition characterized by pah deficiency * ability and willingness to maintain dietary protein intake consistent with baseline intake * willingness and capable per investigator opinion to comply with study procedures and requirements * plasma phe levels \> 600umol/l exclusion criteria: * clinically significant liver dysfunction or disease * prior treatment with gene therapy * any condition that, in the opinion of the investigator or sponsor, would prevent the subject from fully complying with the requirements of the study

Keywords: pku phenylketonuria pah deficiency
evaluation of the effectiveness of day hospital care for adolescents with anxious school refusal

Conditions: School Phobia

Summary: the objective of the study is to evaluate the benefit of day care in a child psychiatric hospital on the return to school and on the development of child psychiatric disorders associated with anxious social refusal.

this is a prospective, longitudinal, single-center observational cohort study carried out on a population of patients followed in a day hospital for anxious school refusal. participating physicians will have the opportunity to recruit their patients over a 12-month period. all enrolled patients will be followed for a minimum of 10 months. the study will be completed as soon as the last enrolled patient has completed a final assessment. aside from the baseline visit, each patient will be assessed only once at 10 months. during each patient visit with the investigating physician, the physician will complete an assessment on the electronic crf.

Eligibility criteria:
inclusion criteria: * patients aged 12 to 18 years * patients with anxious school refusal, defined by a score ≥ 41 on the screen scale * patients receiving day hospital care * patients who have been informed and whose parents (or holder(s) of parental authority) have agreed to their participation in the study and have not objected to the use of their health data exclusion criteria: * patients with a mental disability or any other reason that may hinder the understanding or strict application of the protocol * patients not affiliated with the french social security system * patients under guardianship

Keywords: school phobia anxious school refusal