Kornimate/medical-research-clean huggingface dataset:
a non- inferiority comparative study between seretide® and salmeterol/fluticasone eurofarma in patients with asthma

Conditions: Asthma

Summary: the primary objective will be to compare the formulations regarding their impact on the pulmonary function of persistent asthma patients and the secondary objective will be the clinical control of the disease's symptoms.

the primary objective will be to compare the formulations regarding their impact on the pulmonary function of persistent asthma patients and the secondary objective will be the clinical control of the disease's symptoms. primary endpoint: forced expiratory volume in 1 second (fev1) at the final visit. secondary endpoints: expiratory flow peak (efp), symptoms score, fev1 throughout the study, use of rescue medication, compliance with inhaler use, inhaler acceptance and preference, and frequency of the observed adverse events.

Eligibility criteria:
inclusion criteria: * sign the icf * ≥ 12 years old * have a persistent asthma diagnosis, as per gina classification,18 with symptoms for at least 6 months and clinically stable for at least 1 month with the acq-7 test (please see appendix c) ≤ 3.0 * current use of inhaled corticosteroid (up to 1000 µg of beclomethasone dipropionate) whether combined or not with long-term β2-adrenergics and relief medication (salbutamol or equivalent) * initial fev1 of at least 40% of the normal value expected * blood cortisol evaluation within the normal limits. exclusion criteria: * use of oral or parenteral corticosteroid within the last 3 previous months to the study * hospitalization needed due to asthma within the last 3 previous months to the study * active smokers, defined as the consumption of cigarettes, pipes, cigars or any other form of smoking in any amount within the last 3 months * presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological or psychiatric disease or chronic respiratory disease other than asthma * recent (\<6 months) or expected participation during this study in other clinical trials involving drugs of any nature or in studies consisting of any - intolerance or allergy to any component of the drugs evaluated in the study * pregnant or lactating women * chronic use of routine β-blockers, orally or intravenously, including ophthalmic solutions.
ambulance teletransmited photography for trauma regulation

Conditions: Trauma; Telemedicine

Summary: physicians in charge of medical regulation within french samu have to take difficult decisions regarding patient's orientation (in or out-of hospital care) but suffer from lack of information. such information usually consist in a simple phone conversation without any visual information. visual assesment of the situation would be of great help, especially for traumatized patients. private ambulance societies all over territory in charge of samu 86 now work with teletransmission devices allowing photography transmission. the objective of the study is to determine if routine use of teletransmitted photography help samu 86's physians for a better orientation of non-severe traumatized patients, especially by avoiding unnecessary transportations to emergency departments.


Eligibility criteria:
inclusion criteria: * emergency call at samu for trauma issue * pre-hospital management by private ambulance equipped with teletransmission device exclusion criteria: * severe trauma with need of a pre-hospital emergency medical team * traffic accident * head trauma associated with anticoagulant therapy or platelet antiagregant therapy * pre-hospital management by firefighters
immediate effect of dry needling of the lumbar multifidus on pain sensitivity in a healthy population

Conditions: Low Back Pain

Summary: the goal of this interventional study is to test the effects of trigger point dry needling to the low back in a healthy population. the main aims are to answer: * is there a change in sensitivity to experimental pain after trigger point dry needling * to determine if there is an association between demographic and psychological factors and immediate changes in pain sensitivity after receiving trigger point dry needling. participants will be randomly assigned to one of two groups a dry needling group or a sham dry needling group. the dry needling group will receive trigger point dry needling to the lumbar spine. the sham dry needling group will receive needling to the lumbar spine with a sham needle which does not penetrate the skin. in other words, researchers will compare an intervention group and a sham group to see if dry needling has an immediate change in pain sensitivity in response to experimentally induced pain.

the intent of this study is to investigate the effects of trigger point dry needling on pain sensitivity in a healthy population. in this study, the effects of trigger point dry needling will be measured using quantitative sensory testing. this is a method of testing pain sensitivity by providing a painful stimulus and having the participant rate their response to the stimulus on a pain scale. in this way, the researchers will be able to determine changes to participant's response to painful stimuli and changes to the nervous system after trigger point dry needling interventions to the low back. this information will provide important insight as to how dry needling modulates pain.

Eligibility criteria:
inclusion criteria: * ages 18 - 65 * be pain-free exclusion criteria: * participants will not be excluded on the basis of race or gender but will be excluded if they meet any of the following exclusion criteria: * a) non-english speaker * b) presence of a medical condition known to affect sensation * c) history of surgery to the low back * d) history of blood clotting disorders or medical conditions associated with bleeding disorders * e) current use of the medication causing difficulty with clotting (such as blood thinners) * f) contraindication to the application of needles including, but not limited to, fear of needles or metal allergy --g) women who are pregnant or planning on becoming pregnant any contraindication to application of ice or cold pack, such as: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, and circulatory compromise.

Keywords: trigger point dry needling quantitative sensory testing low back pain
post excision/mohs scar laser resurfacing

Conditions: Skin Cancer

Summary: the purpose of this study is to evaluate the potential benefits of treating a surgical scar post excision with an ablative fractionated co2 laser with the goal of decreasing the appearance and size of the scar.

the objective of this research is to determine, through a split scar study, that treating a post excision scar with a fractionated ablative co2 laser improves both the texture and cosmetic appearance of the scar. an attempt will be made to determine the ideal timing for treating the excision scar as previous studies have ranged from treating the day of the excision up till 10 weeks post-excision. in order to evaluate the treated portion versus untreated portion of the scar, investigators and the subjects will use a quartile rating scale. in addition, punch biopsy samples will be taken to quantify the difference in collagen architecture 9 weeks after treatment with the laser. there will be a total of 7 study visits to include the day of the excision and laser treatment if randomized to this group, post-op day number 14 for suture removal as well as laser therapy if the subject has been randomized to that treatment group, 4 weeks post-op, 9 weeks post-op and laser treatment for subjects randomized to this time frame for treatment, 12 weeks post-op, 17 weeks post-op and 24 weeks post-op. each visit will last approximately 30-45 minutes each in which clinical photos of the surgical scar will be taken and any wound care or side effects of the laser therapy or surgery will be addressed. healing and scar appearance will be reviewed and rated at each of the six postsurgical visits.

Eligibility criteria:
inclusion criteria: * must understand and voluntarily sign an informed consent form. * must be male or female and aged \>18 years at the time of consent. * must be able to adhere to the study visit schedule and other protocol requirements. * patients undergoing skin excisions of the face/trunk/extremities. exclusion criteria: * inability to provide voluntary informed consent * use of laser or light based treatments to affected areas in past year * fitzpatrick skin types 3-5 * surgical lesions located on the central chest * history of keloid formation * history of accutane in the last six months

Keywords: mohs scar post excision co2 laser laser skin cancer resurfacing
study evaluating inotuzumab ozogamicin in acute lymphocytic leukemia

Conditions: Acute Lymphocytic Leukemia

Summary: the phase 1 portion of this study will assess the safety, tolerability and efficacy at increasing dose levels of inotuzumab ozogamicin in subjects with cd22-positive relapsed or refractory adult acute lymphocytic leukemia (all) in order to select the recommended phase 2 dose (rp2d) and schedule. the phase 2 portion of the study will evaluate the efficacy of inotuzumab ozogamicin as measured by hematologic remission rate (cr + cri) in patients in second or later salvage status.


Eligibility criteria:
inclusion criteria: * subjects with cd22-positive all with either refractory disease (i.e. disease progression or no response while receiving their most recent prior anti-cancer therapy), or relapsed disease (i.e. response to their most recent prior anti-cancer therapy with subsequent relapse). subjects enrolled in the phase 2 portion of the study must be due to receive salvage 2 or later therapy. * subjects with philadelphia chromosome-positive (ph+) all must have failed standard treatment with at least one tyrosine kinase inhibitor. * adequate renal and hepatic function, and negative pregnancy test for women of childbearing potential. exclusion criteria: * subjects with isolated extramedullary relapse or active central nervous system (cns) leukemia. * prior allogeneic hematopoietic stem cell transplant (hsct) or other anti-cd22 immunotherapy within 4 months, or active graft versus host disease (gvhd) at study entry. * evidence or history of veno-occlusive disease (vod) or sinusoidal obstruction syndrome (sos).

Keywords: relapsed/refractory acute lymphocytic leukemia (all)
turkish validity and reliability of sgrq-i

Conditions: IPF

Summary: the saint george respiratory questionnaire (sgrq) questionnaire is a frequently used questionnaire in the respiratory patient group, and the turkish version of this questionnaire, which was created for use in idiopathic pulmonary fibrosis patients, is not available. there is no commonly used quality of life questionnaire in patients with idiopathic pulmonary fibrosis. the aim of the study is to translate and validate the sgrq idiopathic pulmonary fibrosis version of questionnaire into turkish.

* the study is a cross-sectional, questionnaire validation study. * it is planned to complete the study within 2 years after the sufficient sample size is reached and the evaluations are made. the study will be terminated when the sufficient number of patients is reached. * the main thing in the application of special tools such as questionnaires is to prove the usability of the tool in the sample group to which it will be applied. the first step for this is the translation phase from the original language to the other language. at this stage, it is ideal for people who know the structure of the target language and the original language well, who have a good command of these languages and who are experienced in doing the translation. in our study, two people who are fluent in the original language will translate the questionnaire into the target language and two different people will translate the original language again. * to the participants; demographic evaluation form, saint george's respiratory questionnaire (sgrq), and sgrq idiopathic pulmonary fibrosis version of questionnaire (sgrq-i) will be applied. the sgrq-i questionnaire will be administered again one week after the first application date in order to determine the test-retest reliability. * scale reliability will be tested with cronbach alpha.for construct validity, confirmatory factor analysis will be applied and confirmatory factor analysis will be applied. for content validity, opinions of different experts will be taken for each item, and the status of items in the scale will be determined according to the results obtained by substituting it. in the logical validity process; coverage of the components constituting the measured skill for each item will be considered.

Eligibility criteria:
inclusion criteria: * be over 18 years old * having a diagnosis of idiopathic pulmonary fibrosis * to be literate in turkish exclusion criteria: * exacerbation or exacerbation in the last 6 weeks * presence of comorbidities affecting ambulation * cognitive impairment

Keywords: sgrq sgrq-i ipf quality of life
online spaced education to improve fall prevention by patients with multiple sclerosis

Conditions: Education of Patients

Summary: multiple sclerosis (ms) is a chronic, progressive and neurodegenerative inflammatory disease that affects young adults. in many countries it has been described as the main cause of neurological incapacity in this age group. due to the neurological impairment, patients with multiple sclerosis have a high incidence of fall. according to studies, ms patients fall three times more than general population. in the present study, the question to be answered is: education of individuals with ms on fall prevention using the method of online spaced education provides better retention of knowledge than the traditional method? this is a clinical trial to compare two methods of education of ms patients for prevention of fall. first stage: development and validation of materials. step two: pilot questions with ms patients. step three: intervention and evaluation of outcome.


Eligibility criteria:
inclusion criteria: * multiple sclerosis diagnosis * accept to be part in the study * have valid e-mail address exclusion criteria: - healthcare professionals;

Keywords: fall multiple sclerosis
lbh589 in adult patients with advanced solid tumors or cutaneous t-cell lymphoma

Conditions: Tumors; Cutaneous T-Cell Lymphoma

Summary: the phase i study will evaluate the safety, efficacy and pharmacokinetics of lbh589b in adult patients with advanced solid tumors or cutaneous t-cell lymphoma


Eligibility criteria:
inclusion criteria: * patients with either a) histologically-confirmed, advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists, or b) cytopathologically confirmed cutaneous t-cell lymphoma (ctcl) whose disease has progressed despite standard therapy or for whom no standard therapy exists. inclusion is irrespective of stage of disease or extent of prior therapy. * world health organization (who) performance status of ≤ 2 * patients must have the adequate laboratory values exclusion criteria: * patients with a history of primary cns tumors * patients with any history of brain metastases * patients with any peripheral neuropathy ≥ ctcae grade 2 * patients with unresolved diarrhea ≥ ctcae grade 2 * impairment of cardiac function * impairment of gastrointestinal (gi) function or gi disease * liver or renal disease other protocol-defined inclusion/exclusion criteria may apply

Keywords: advanced solid tumor cutaneous t-cell lymphoma phase i hdac inhibitor adult patients
a study of invirase (saquinavir)/ritonavir in hiv-infected infants and children.

Conditions: HIV Infections

Summary: this single arm study will assess the pharmacokinetics, safety and activity of saquinavir (invirase hard gel capsules, film coated tablets or opened capsules) boosted by combination with ritonavir, in hiv-1 infected infants and children between the ages of 4 months and 6 years. patients will commence treatment with saquinavir 50mg/kg bid plus ritonavir 2.5mg/kg or 3.0mg/kg (dependent on body weight), and a background antiretroviral regimen. if drug exposures are found to be dissimilar to those previously seen in older children and adults, or are associated with toxicities, subsequent dose adjustments will be made. the anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * infants and children, 4 months to \<6 years; * confirmed hiv-1 infection; * patients for whom saquinavir/ritonavir together with \>=2 background arvs is considered appropriate. exclusion criteria: * body weight \>4kg/8.8 pounds; * use of any concomitant medications that may interfere with the pharmacokinetics of saquinavir or ritonavir; * malabsorption, severe chronic diarrhea or vomiting within 28 days of the study.
effect of sedative agent on reducing the frequency of arrhythmia in the patients after cardiac surgery

Conditions: Arrythmia

Summary: arrhythmias early in the recovery period after cardio thoracic surgery are common they develop in 11 to 40 percent of patients after coronary-artery bypass grafting. the right chose of sedative agent could decrease the level of arrhythmia incidence.

arrhythmias are really common in patients after cardiac surgery. most of the patients get sedation after cardiac surgery. the goal is to determine if the propofol (pr) (sedative agent), dexmedetomidine (dex)(selective α2-adrenergic receptor (α2-ar) agonist) or their combination could improve and decrease the incidence of the arrhythmia in patients after cardiac surgery.

Eligibility criteria:
inclusion criteria: * multi vascular lesions of the coronary arteries according to coronary angiography; * heart valve damage was confirmed by heart ultrasound, which is subject to surgical correction (aortic stenosis of iii degree with a gradient on the aortic valve of more than 42 mmhg, aortic insufficiency iii, mitral valve stenosis ii-iii, mitral regurgitation ii-iii) * age of patients from 18-80 years; exclusion criteria: * refusal to participate; * hypersensitivity to propofol, dexmedetomidine; * acute renal failure that occurred during surgery (clcr less than 50 ml / h, or a decrease in the rate of diuresis to 0.1 ml / h in the first 4 hours after surgery and does not respond to diuretic therapy)
management of acute uncomplicated utis in adults by community pharmacists

Conditions: Urinary Tract Infections; Urinary Tract Infection Lower Acute

Summary: this study is to be conducted in community pharmacies. it involves the use of trained mystery patients to evaluate community pharmacists at baseline and post intervention. the pharmacists will be divided into control and intervention groups using computer generated codes. those in the intervention group will receive an online training by clinical pharmacists. the training will employ the use of didactic teaching and the use of case studies and simulations covering the diagnosis and management of acute uncomplicated urinary tract infections in adults. post intervention, mystery patients will revisit the community pharmacists in the control and intervention groups for re-assessment.


Eligibility criteria:
inclusion criteria: * the superintendent pharmacist, or the pharmacist manager or any other post national youth service corps pharmacist exclusion criteria: * interns, and pharmacists undergoing the mandatory national youth service corps program.

Keywords: urinary tract infections pharmacist mystery patient
nebulized dexmedetomidine as a premedication for gastrointestinal endoscopy in pediatric patients

Conditions: Pediatric; Sedation

Summary: this study aims to demonstrate that the application of nebulized dexmedetomidine to patients during pediatric upper gastrointestinal endoscopic procedures will significantly reduce the gag reflex and enhance both patient and practitioner comfort

due to the intolerance of pediatric patients to the insertion of the endoscopic probe during upper gastrointestinal procedures, sedation and analgesia are required. in this patient group, the reflex to vomit is common during probe placement. discomfort, pain, and hemodynamic changes can occur due to the vomiting reflex. in fact, this situation can lead to serious complications such as esophageal rupture. inappropriate sedation conditions may result in increased post-procedural pain and agitation in patients. therefore, various sedative drugs are used for procedural sedation in pediatric patients. the use of these drugs during gastrointestinal endoscopy in the pediatric population can vary in terms of sedative, hemodynamic, respiratory, and side effects. dexmedetomidine, a highly selective alpha-2 agonist with central sedative and anxiolytic properties, has been tested in children for preoperative anxiolysis through nasal and inhalation routes. due to its bioavailability of up to 82%, it is well absorbed systemically through oral and buccal routes.' it possesses sedative, analgesic, sympatholytic, and hemodynamic stability properties. even at high doses, it has a unique feature of not causing respiratory depression, which gives it an advantage over other sedatives such as benzodiazepines, opioids, and propofol, all of which can cause dose-dependent respiratory depression. in this regard, it may be a good alternative for procedures like gastrointestinal endoscopy. based on these considerations, the investigators plan to conduct a randomized controlled study hypothesizing that nebulized dexmedetomidine as premedication in pediatric patients undergoing gastrointestinal endoscopy will significantly reduce the gag reflex. 108 patients will be included in the study. patients will be divided into 2 groups. * the control group (group c) * the group receiving nebulized dexmedetomidine (nd) (group nd).

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status i and ii * 2 to 17 years of age, * patient undergoing in upper gastrointestinal endoscopy exclusion criteria: * patients with heart disease * patients with mental-motor retardation * patients with abnormal upper respiratory tract * patients with a history of asthma * patients with upper respiratory tract history in the last 4 weeks * patients with severe sleep apnea on polysomnography * asa \>iii patients * patients with drug allergies

Keywords: pediatric gastrointestinal endoscopy dexmedetomidine
efficacy and safety of atl-962 in obese diabetics

Conditions: Non-Insulin-Dependent Diabetes Mellitus; Obesity

Summary: the purpose of this study is to investigate whether atl-962 induces weight loss in diabetic patients and whether its safety and tolerability profile is superior to that of orlistat in such patients

obesity is a significant and increasing clinical problem. there is a need for effective therapeutic agents to help people reduce weight. atl-962 is a lipase inhibitor which could reduce the amount of fat absorbed from a person's diet, leading to weight reduction. in this study patients with type ii diabetes who are clinically obese will receive atl-962 at one of three dose levels, or placebo, or orlistat (another lipase inhibitor). the study will investigate the amount of weight lost after 12 weeks' treatment and will compare the safety and tolerability profile of atl-962 and orlistat.

Eligibility criteria:
inclusion criteria: * type ii diabetes * body mass index 28-45kg/m2 * hba1c 6%-10% exclusion criteria: * significant weight loss in the previous 3 months * weight gain during the run-in period * other serious systemic conditions, except controlled hypertension, mild asthma, and primary hypothyroidism * history of gi disorders * previous surgery for weight loss

Keywords: non-insulin-dependent diabetes mellitus niddm type ii diabetes obesity lipase inhibitor