Kornimate/medical-research-clean huggingface dataset:
a phase iii study to assess efficacy and safety of staloral® 300 ir sublingual immunotherapy (slit) in asthmatic patients allergic to house-dust mites

Conditions: Allergy

Summary: a phase iii study to assess the efficacy and safety of sublingual immunotherapy with staloral dust mites solution compared with placebo for reduction of asthma symptoms.


Eligibility criteria:
inclusion criteria: 1. male or female outpatients aged 16 to 50 years (inclusive). 2. house dust mite-induced allergic asthma with or without perennial allergic rhinitis for at least 1 year. 3. sensitised to d. pteronyssinus and d.farinae (positive skin prick test (spt) with wheal diameter ≥ 4 mm and specific ige level ≥ 0.70 ku/l 4. patients treated with inhaled corticosteroids (ics) before the screening visit at a dose ≥ 200 µg and \< 1,000 µg equivalent budesonide/day. exclusion criteria: 1. mild intermittent asthma needed to be treated only with β2-agonist (gina level 1). 2. severe asthma needed to be treated with inhaled corticosteroids with a dose ≥ 1,000 µg/day equivalent budesonide. 3. fev1 \< 70% of predicted value at visit 1. 4. co-sensitisation to other inhalant allergens than dust mites leading to clinically relevant allergic asthma and proven by a positive skin prick test with wheal diameter ≥ 4 mm and serum specific ige ≥ 0.70 ku/l . 5. patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or the outcome of the study. these diseases include, but are not limited to, past or current cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease.

Keywords: allergy slit asthma house dust mites
use of analgesic drugs in renal colic in emergency room

Conditions: Renal Colic

Summary: a prospective non-interventional study on the use of analgesic drugs in renal colic in emergency rooms


Eligibility criteria:
inclusion criteria: * patients older than 18 years old * suspicion of renal colic (pain in a lumbar pit radiating to the external genital organs, rapidly progressive onset, non-febrile) exclusion criteria: * shock * glasgow score less than 15 * oxygen saturation less than 93% in ambient air * signs of intracranial hypertension (headache associated with vomiting) * suspicion of pneumothorax * history of emphysema or chronic obstructive pulmonary disease * diving accident or suspicion of gas embolism * trauma of the face of interest in the area of application of the mask * abdominal gas distension * contraindication in nonsteroidal anti-inflammatory drugs * pregnancy
feasibility study: treatment of post-surgery and surgery naive patients who failed to respond to a previous ulthera treatment

Conditions: Skin Laxity

Summary: up to 10 subjects will be enrolled. all subjects will receive an increased density ultherapytm treatment at dual depth. treatments will be provided to the lower 2/3 of the face and neck. follow-up visits will occur at 90 and 180 days post-treatment. study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.

this is a prospective, single-site, non-randomized clinical trial efficacy of an additional ultherapy™ treatment for subjects who were minimal or non-responders at day 90 in a previous ulthera clinical trial. global aesthetic improvement scale scores and patient satisfaction questionnaires will be obtained.

Eligibility criteria:
inclusion criteria: * male or female, age 30 to 65 years. * subject in good health. * bmi \< 30. * skin laxity in the submental area as demonstrated by a grade ii or iii on the knize scale for classification of cosmetic deformity of the cervicomental angle * previous participation in ult-107, and adequate compliance with all treatment and follow-up visits. groups (surgery or surgery naïve) will be designated based on group assigned in ult-107). * have not had any concomitant surgical or skin tightening procedures since their ultherapy™ treatment with ult-107. exclusion criteria: * pregnant, lactating, or are planning to become pregnant, and/or not using a reliable form of birth control. * presence of an active systemic or local skin disease that may affect wound healing. * severe solar elastosis. * excessive subcutaneous fat on the cheeks. * excessive skin laxity on the lower face and neck * significant scarring in areas to be treated. * open wounds or lesions in the area to be treated. * severe or cystic acne on the area to be treated

Keywords: ulthera® system ultherapy™ treatment ulthera, inc. ultrasound treatment for skin tightening
multi-modal adverse events prediction for premature coronary heart disease trial: map-chd trial

Conditions: Premature Coronary Heart Disease

Summary: the goal of this observational cohort study is to establish a risk prediction model for adverse events in chinese individuals under 45 years old with premature coronary artery disease. the main questions it aims to answer are: * what are the major risk factors for poor prognosis in chinese patients with premature coronary artery disease? * what is the difference in the prognosis of patients with premature coronary heart disease with different phenotypes? participants taking no mandatory intervention will be followed up for 2 year, with blood tests at 1 year and outpatient or telephone interviews at other timepoints.


Eligibility criteria:
inclusion criteria: * age 18-45 years; * clinically confirmed cad with ≥50% luminal stenosis in at least one major coronary artery or significant branch, verified by coronary angiography; * for acute coronary syndrome (acs) or percutaneous coronary intervention (pci) patients: clinical stability meeting discharge criteria post-treatment; * voluntary participation with signed informed consent. exclusion criteria: * heart transplant recipients; * severe systemic comorbidities with life expectancy \<1 year; * previous enrollment in other drug/device clinical trials without completing the primary endpoint observation period; * inability to comply with follow-up (e.g., dementia, severe psychiatric disorders).
ventilatory and perfusion abnormalities in individuals with post-acute sequelae of sars-cov-2 infection

Conditions: Post-Acute COVID-19; Post COVID-19 Condition; Post Viral Fatigue; Dyspnea

Summary: prospective cohort study to evaluate the utility of quantitative ct analysis to assess ventilation and perfusion defects in patients with post-acute sequelae of sars-cov-2 (pasc) and functional limitations

this is a study to describe the overall pattern of lung ventilation and perfusion defects in individuals with pasc. subjects with pasc with a documented history of covid-19 and persistent symptoms of fatigue, dyspnea, and/or exercise intolerance will complete questionnaires, and undergo pulmonary function tests, 6-minute walk tests, and a low dose ct chest to describe the overall pattern of lung regional ventilation and blood distribution and to compare this pattern to asymptomatic controls with and without prior covid-19.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * self-reported or documented sars-cov-2 infection by rt-pcr or antigen testing \> 3 months ago or no previous history of sars-cov-2 infection (control group only) * normal or mild abnormalities on baseline pulmonary function tests (pfts) * new or worsening symptoms of chronic fatigue, dyspnea or exercise intolerance after covid-19 with otherwise unclear etiology (pasc group only) exclusion criteria: * sars-cov-2 infection by rt-pcr or antigen testing within the last 3 months * inability to provide consent or non-english speaking * pregnancy * any respiratory infection in last 4 weeks * pft relative contraindications * history of major cardiovascular, pulmonary, renal, hepatic, autoimmune or neuromuscular disease including asthma, copd, interstitial lung disease, heart failure, pulmonary arterial hypertension, or prior pulmonary embolism * active malignancy undergoing treatment or history of malignancy involving the lung

Keywords: ventilation perfusion mismatch
development of a therapeutic education program for patients with metastatic prostate cancer treated with new generation hormone therapy

Conditions: Prostate Cancer

Summary: the development of a personalized therapeutic education program dedicated to patients with metastatic prostate cancer and receiving next-generation hormone therapy would improve their knowledge of the disease, medication adherence and quality of life.


Eligibility criteria:
inclusion criteria: * patients with metastatic prostate cancer treated with enzalutamide or abiraterone acetate for at least 3 months * the patient must have given their free and informed consent and signed the consent form * the patient must be insured or the beneficiary of an insurance policy exclusion criteria: * the subject is not in a fit state to express their consent * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship
mobile transmission of prehospital vital signs to the emergency department

Conditions: Telemedicine; Triage; Emergency Medical Service

Summary: the purpose of this study is to examine if real time transmission of vital signs, ecg and chat communication between the prehospital ambulances and the emergency department has an effect on patient mortality, icu admission, hospitalization time, time to doctor, time to treatment and time to diagnostics


Eligibility criteria:
inclusion criteria: * all patients transported with ambulance to the emergency department exclusion criteria: * none

Keywords: telemedicine mobile vital signs prehospital care emergency medicine
trip-tox, effectiveness of triptans before and after onabotulinumtoxin a treatment in chronic migraine

Conditions: Chronic Migraine

Summary: observational, longitudinal, prospective, prospective, comparative study of the effectiveness of triptans before and after onabotulintoxin a initiation in a single group of chronic migraine patients.

hypothesis in patients with chronic migraine the efficacy of triptans, previously taken by the patient for the migraine attack, is better and more satisfactory after starting treatment with onabotulinumtoxina. objectives to analyze the efficacy and satisfaction of the triptan usually taken by the patient with chronic migraine before starting preventive treatment with onabotulinumtoxina, at 4 months, after two sessions of botox, and at 7 months of treatment, after three sessions of botox. sample size n=100 patients with chronic migraine in whom treatment with onabotulinumtoxina is indicated. the indication for botox treatment will be performed as usual and the patient will take his usual triptan if he has a migraine attack, so there is no therapeutic modification in this study that could involve any bioethical issue. all patients signed the informed consent and the study was approved by the comitè d'ètica de la investigació amb medicaments (ceim) de l'hospital de la santa creu i sant pau.

Eligibility criteria:
inclusion criteria: * ichd-3 criteria for chronic migraine (code 1.3). see table 3. * older than 18 years and younger than 65 years. * migraine started in their lifetime before the age of 50 years. * migraine of more than one year of evolution since diagnosis. * normal cranial ct/mri study. * indication for treatment with botox * taking triptans as a rescue treatment for migraine attacks exclusion criteria: * pregnant women * migraine of less than one year of evolution since diagnosis. * pathologies that contraindicate the use of onabotulinumtoxina (myasthenia gravis, myopathies).
follow-up evaluating clinical and radiological outcomes of total shoulder arthroplasty with permedica's mirai prosthesis

Conditions: Cuff Tear Arthropathy; Primary Osteoarthritis; Secondary Osteoarthritis; Shoulder Osteoarthritis; Rheumatoid Arthritis Shoulder; Psoriatic Arthritis; Fracture, Shoulder; Avascular Necrosis of Humerus

Summary: this observational study is conducted in order to evaluate the effectiveness of the primary total shoulder arthroplasty with the permedica's mirai modular shoulder prosthesis system on the general population of patients who are about to undergo this surgery for every indication. patients requiring a revision shoulder arthroplasty will not be enrolled. the effectiveness will be evaluated in terms of recovery of shoulder function and stability of the prosthetic implant. the incidence of complications, adverse and serious adverse events will also be studied. additional study aim is to evaluate a medium/long term survival of the prosthesis. the duration of the study per single subject is 5 years.


Eligibility criteria:
inclusion criteria: * both genders * at least 18 years old of age * undergoing a primary total shoulder arthroplasty with mirai® prosthesis system (anatomic or reverse, stemless or stemmed). * signed informed consent exclusion criteria: * patients requiring a revision shoulder arthroplasty * persistent chronic or acute infections and all septic conditions * persistent osteomyelitis local or systemic * allergy or hypersensitivity to the substances contained in the materials of the implanted components * acute or chronic neurological and/or musculoskeletal impairment which compromises the shoulder joint function such as an axillary nerve injury affecting the deltoid muscle * inadequate bone structure which cannot guarantee stability to the prosthetic components * several vascular, nerve or muscular disorders, which compromise related extremities * marked osteoporosis, osteomalacia * hypotrophy of the periarticular soft tissues * dysmetabolic diseases such as, for example, kidney failure or systemic diseases * muscular insufficiency * active neoplastic or metastatic diseases * any other clinical or physical condition that can invalidate the surgery, the rehabilitation or the prosthesis stability * patient unwilling or unable to undergo the rehabilitation or to return to follow-up visits * women in pregnancy, childbearing potential or breastfeeding * involvement in other ongoing studies or clinical trial.

Keywords: total shoulder arthroplasty shoulder prosthesis observational study cuff tear arthropathy shoulder osteoarthritis
walant in distal radius fracture osteosynthesis

Conditions: Radius Fracture Distal

Summary: the purpose of this study is to assess the applicability and potential benefits of wide awake local anesthesia no tourniquet (walant) or local anesthesia no tourniquet ("lant) versus locoregional anesthesia (lra) and tourniquet in osteosynthesis of distal radius fractures (drf) during the immediate postoperative period. our hypothesis is that being able to avoid the use of a limb tourniquet in such a procedure may cause less swelling and better surgical wound appearance in the immediate postoperative period, without compromising pain level, patient satisfaction, or improving the number of complications. in this regard, prospective randomized study was designed comparing short term results of patients who were operated using walant (a) to locoregional anesthesia (lra) and tourniquet (b). main outcomes were pain, swelling and patient satisfaction. surgical wound bleeding,mobility, surgeon's technical difficulty, insufficient anesthesia and complications were also evaluated.


Eligibility criteria:
inclusion criteria: * patients who attended our hospital from december 2020th to december 2021 with drf requiring surgical treatment who provided written informed consent and did not have any of the following excluding conditions described below exclusion criteria: 1. unsigned informed consent 2. 17 years old or younger 3. associated fractures in which additional osteosynthesis was required: scaphoid fracture, ulnar fracture (ulnar styloid osteosynthesis included), bifocal radius fractures, etc 4. open fractures 5. polytrauma patients 6. requiring more than a standard volar drf approach and/or other than a volar plate. 7. drf with \>30 days or drf malunions contraindications to the use of ischemia a. peripheral vascular disease b. extensive soft tissue injury c. peripheral neuropathy d. severe infection e. thromboembolic disease in the extremity f. poor skin conditions g. arteriovenous fistula h. sickle cell hemoglobinopathy contraindications for proximal blocking: 1. existence of previous trauma or anatomical distortion of the area that prevents the abduction of the arm 2. active presence of infection at the locoregional anesthesia puncture site 3. previous axillary lymphadenopathy 4. previous history of local anesthetic allergy 5. severe coagulopathy 6. severe pre-existing neurological diseases in the upper extremity contraindications for walant anesthetic technique 7. documented hypersensitivity to lidocaine 8. compromised peripheral circulation 9. patients with previous vascular pathology, a history of vasculitis, buerger's disease, and scleroderma 10. patients with infection of the area surrounding the injection

Keywords: radius fracture distal local anesthesia brachial plexus anesthesia osteosynthesis, fracture
binocular vision in monocular pseudophakia

Conditions: Cataract

Summary: following cataract surgery, an intraocular lens (iol) is implanted in the eye. the majority of people develop an operable cataract when they are over the age of 50. occasionally people under 50 years develop a cataract requiring an operation. the visual demands in this age group are very different due to both physiological and lifestyle factors. traditionally iols are focussed for distance vision and additional spectacles are worn for near vision. under the age of 45 years we have the ability to naturally change the focus of our eyes and do not require additional reading glasses. this is known as accommodation. by removing the cataractous lens and replacing it with an iol with a fixed single focus, both eyes work together for distance vision but only the unoperated eye is able to change focus for different working distances. this study aims to establish whether a multifocal iol implanted in one eye is able to complement the accommodation in the other eye so the 2 eyes work more effectively together. this may enhance depth perception and improve the quality of vision. depth perception is important for more comfortable vision on the computer screen, when reading and for jobs that require good depth perception.


Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * male or female, aged 18 - 45. * cataract operation required in one eye only, either due to the presence of cataract affecting visual function, or in combination with surgery which is likely to cause visually significant cataract. * expected visual improvement in operable eye of at least 6/12. * fellow eye with a va of at least 6/9. * astigmatism of 1.0d or less. * target of emmetropia in the operated eye. * intact posterior capsule with planned implantation into the capsular bag. * iol power required 10 - 30d. exclusion criteria: * pre-existing amblyopia or squint. * significant diabetic retinopathy. * macular off retinal detachment with metamorphopsia or poor visual prognosis. * other macula or ophthalmic pathology affecting macula function resulting in poor visual prognosis. * pregnancy, lactating or planned pregnancy during the study period.

Keywords: intraocular lens phacoemulsification
multicomponent intervention in women at risk of sarcopenia

Conditions: Sarcopenia; Grip Strength; Gait Speed; Body Composition

Summary: the goal of this quasi-experimental pilot study is to evaluate the effect of a multi-component intervention in women between 55 and 75 years old at risk of sarcopenia. the main question it aims to answer are: what is the effect of a multi-component intervention in women at risk of sarcopenia? participants will twelve women between 55 and 75 years old with risk of sarcopenia, who agreed through written informed consent for participate 12 weeks with 24 sessions included dancing, resistance exercises, and nutritional education. the outcomes were muscle mass, grip strength, gait speed and body composition. the effects were measured before and after the intervention, under a self-controlled design.

physical exercise, especially resistance exercise, is one of the best non-pharmacological treatment alternatives due to its multiple health benefits and could be a promoter for the prevention of sarcopenia by delaying muscle atrophy produced by the natural aging process. however, scientific literature shows that this activity when combined with other strategies has a better effect on sarcopenia indicators than alone. dance is a social activity that is part of the culture and life history of human beings, however, current research has focused on studying the cognitive and visuospatial effects of this activity. it could be an activity with beneficial effects on the physical abilities of the individual since dancing improves flexibility, resistance and balance. however, the study of these two strategies, along with nutritional education has been little studied. therefore, a pilot test was proposed with the aim of knowing the possible effect of a multicomponent intervention on muscle, strength, performance, and body composition on women at risk of sarcopenia.

Eligibility criteria:
inclusion criteria: * positive requested through written informed consent * current public health insurance * preserved physical and mental capacities (verified through data from the medical record) * having a lower grip strength, less or equal to 20.99 kg * appendicular skeletal muscle index (asmi) maintained, greater or equal to 5.5 kg/m\^2 * walking speed greater or equal to 0.8 m/s exclusion criteria: * bioelectric activity add (osteosynthesis metal systems or devices, pacemakers, defibrillators) * alterations of body composition (history of cancer, uncontrolled chronic degenerative diseases, risk of malnutrition, respiratory insufficiency, asthma or chronic obstructive pulmonary disease, hospitalization in the year prior to the study; limitations in carrying out the basic activities of daily living; medical contraindication for physical activity, and or belonging to another physical activity group).

Keywords: sarcopenia multicomponent aging preventive