Kornimate/medical-research-clean huggingface dataset:
study to compare the pharmacokinetics of fixed-dose combination of mometasone + azelastine nasal spray to mometasone and azelastine nasal sprays in adolescents and young adults with seasonal allergic rhinitis

Conditions: Seasonal Allergic Rhinitis

Summary: this study will compare the pk parameters of the combination test formulation to monotherapy reference products (mometasone furoate and azelastine hydrochloride) in adolescents and young adult patients with seasonal allergic rhinitis.


Eligibility criteria:
inclusion criteria: 1. non-smoking, adolescent or young adult male and female subjects with seasonal allergic rhinitis. 2. willing to use acceptable, effective methods of contraception. 3. be informed of the nature of the study and give written consent (adults) / assent and consent by legal guardian(s)/parent(s) (adolescents) prior to any study procedure. exclusion criteria: 1. known history or presence of clinically significant disease or any other condition which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results. 2. known history or presence of hypersensitivity or idiosyncratic reaction to mometasone, azelastine, or any other drug substances with similar activity. 3. unable to tolerate direct venipuncture. 4. positive test result for hiv, hepatitis b surface antigen, or hepatitis c antibody. 5. positive test result for urine drugs of abuse or urine cotinine. 6. presence of nostril or septum piercing. 7. use of tobacco or nicotine-containing products within 6 months prior to drug administration. 8. females who are pregnant, breast-feeding, or have used hormonal contraceptives within 21 days (oral and transdermal) or 6 months (implanted, injected, intravaginal, or intrauterine) prior to drug administration. 9. donation or loss of whole blood (including clinical trials) within 30 days prior to drug administration (or 56 days for ≥500 ml). 10. participation in a clinical trial that involved administration of an investigational medicinal product within 30 days prior to drug administration, or recent participation in a clinical investigation that, in the opinion of the investigator, would jeopardize subject safety or the integrity of the study results. 11. received any type of live vaccine within 30 days prior to drug administration. 12. use of medication within 30 days prior to drug administration. 13. on a special diet within 30 days prior to drug administration. 14. have had a tattoo or body piercing within 30 days prior to drug administration.
the montreal cognitive assessment.test in adults with sickle cell disease

Conditions: Sickle Cell Anemia

Summary: this study will assess the performances of the montreal cognitive assessment (moca) to screen for cognitive impairment in adults with sickle cell anemia. the results of the moca and its subscores will be compared to a standardized neuropsychological evaluation using validated tests.

sickle cell anemia is a monogenic disease affecting the beta-chain of hemoglobin. cognitive impairment is more prevalent in patients with sickle cell disease than in matched unaffected individuals. validated tests to screen for cognitive impairment are lacking in this population. our goal is therefore to assess the performance of the montreal cognitive assessment (moca) as a screening tool for cognitive impairment in adults with sickle cell anemia. the results of the moca and its subscales will be compared to a standardized neuropsychological evaluation using validated tests.

Eligibility criteria:
inclusion criteria: * sickle cell disease, ss or sbêta0 subtypes only * attending a consultation or a daycare hospitalization in the tenon hospital sickle cell center * aged 18 years old or more * providing written informed consent * with health insurance exclusion criteria: * obvious cognitive impairment of neurologic (e.g. previous stroke) or psychiatric origin (e.g. psychotic disorder with negative symptoms) * insufficient french language fluency to understand the tests, inability to read and write or with no schooling beyond primary school * anticipated unavailability in the next 6 months * patients under supervision \& guardianship

Keywords: sickle cell anemia cognitive dysfunction sensitivity and specificity diagnostic techniques and procedures neuropsychological tests montreal cognitive assessment
observational examination of thermoregulation in total joint arthroplasty

Conditions: Hypothermia

Summary: total joint patients have poor outcomes with infection since they are having permanent hardware implanted. infection prevention in this group is therefore critical and a major source of discussion in both the orthopedic and anesthesia literature. hypothermia has been shown to increase the risk of infection and blood loss. however, studies have not examined when in the operation or how fast patients temperatures drop. this study will observe how patients' temperatures change during total joint arthroplasty. by identifying when body temperature changes occur, prevention strategies may be developed and implemented.

peri-operative hypothermia can have deleterious effects. while there is no standard consistent definition within the literature mild hypothermia is commonly defined as a core temperature between 34 and 36 °c. mild hypothermia has been shown to increase the occurrence of surgical site infections, cardiac morbidity, coagulopathy leading to increased blood loss and transfusion requirements, impaired drug metabolism, and prolonged emergence from anesthesia. in addition, there is evidence that maintaining intra-operative normothermia can shorten hospital length of stay. despite the fact that intra-operative temperature monitoring and warming are considered standard of care, peri-operative hypothermia in total joint arthroplasty patients remains an issue for several reasons. a large proportion of patient undergoing joint replacement are elderly, making them susceptible to peri-operative hypothermia. in addition, regional anesthesia causes vasodilation and promotes heat flow from the core to the periphery and impairs central and autonomic thermoregulation such that patients receiving neuraxial anesthesia can be particularly susceptible to perioperative hypothermia. finally, core temperature monitoring is typically not used during regional anesthesia and hypothermia may go undetected for long periods of time. the primary goal of this study was to examine the incidence of hypothermia during lower extremity arthroplasty. a secondary aim was to identify patient and operative factors associated with hypothermia in order to improve future preventative strategies. our hypothesis was that peri-operative hypothermia occurs in the majority of patients undergoing lower extremity arthroplasty. in addition, we hypothesized that certain patient and anesthetic factors (such as low body mass index and receiving general anesthesia) would increase the incidence of hypothermia.

Eligibility criteria:
inclusion criteria: * adults 18 years of age and over that are scheduled to undergo total hip or total knee joint arthroplasty. exclusion criteria: * patients unable to give informed consent will be excluded.

Keywords: hypothermia total hip joint prosthesis total knee joint prosthesis
a pilot study to evaluate the use of the amma portable scalp cooling system from cooler heads

Conditions: Alopecia; Chemotherapy-induced Alopecia; Hair Loss; Breast Cancer; Gynecologic Cancer

Summary: eligible patients will be recruited prior to initiation of chemotherapy for any stage breast or gynecologic cancer. patients will undergo training in the use of the amma portable scalp cooling system and will use the device during each of their chemotherapy treatments. quality of life and experience of use questionnaires will be completed. scalp photos and an assessment of hair loss will be preformed at enrollment and at the end of study participation.

amma is designed to be used by patients in the chemotherapy infusion center, during transport from the infusion center to home, and after arrival at home. patients will participate in training in amma use and will be asked to bring the device to the chemotherapy infusion center for use during each chemotherapy treatment visit. the device will be used for 30 minutes prior to the start of chemotherapy, during chemotherapy and for 2 hours after chemotherapy. scalp photos will be obtained at baseline and after the last chemotherapy treatment. patients will be asked to complete the following questionnaires: training evaluation after training is complete; and symptoms from device use, experience with device use and self-assessment of hair loss after each chemotherapy treatment.

Eligibility criteria:
inclusion criteria: * female age 21 years or older at the time of signing informed consent. * documented pathologic diagnosis of invasive breast or gynecologic cancer, any stage, requiring treatment with a taxane-containing chemotherapy regimen * planned start of treatment with taxane-based chemotherapy in the adjuvant, neoadjuvant or advanced setting * plan to complete chemotherapy within 6 months of treatment start * if received prior chemotherapy causing hair loss, \>/= 2 years since last chemotherapy dose and complete recovery of hair * ecog performance status 0-1 * willing and able to sign informed consent for study procedures * willing and able to participate in all study procedures exclusion criteria: * plan to use chemotherapy regimen other than that listed in inclusion criteria, including any anthracycline-based regimen * plan to initiate bone marrow ablation chemotherapy * history of or plan to initiate whole or partial brain or skull irradiation * hormone therapy concurrent with current chemotherapy regimen * existing or suspected scalp metastases * history of concomitant diagnosis of: autoimmune disease affecting hair; cryoglobulinemia; untreated iron deficiency with or without anemia; cold agglutination disease; post-traumatic cold dystrophy; untreated or poorly controlled hyper- or hypothyroidism * female pattern baldness * history of persistent chemotherapy-induced alopecia from prior chemotherapy * concomitant exposure to investigational agents, drugs, devices or procedures that cause hair loss * concomitant other solid tumor or hematologic malignancy in addition to the current diagnosis
validation of the critical-care pain observation tool (cpot) in the greek population

Conditions: Pain; Intensive Care Units

Summary: the aim of this study is to validate the critical-care pain observation tool (cpot) in the setting of the intensive care unit (icu). prior to patient recruitment the tool will be translated by the method of translation-back translation by greek and english native speakers. the tool will be administered to patients who are admitted into the icu.

the aim of this study is to validate the critical-care pain observation tool (cpot) in the setting of the intensive care unit (icu). prior to patient recruitment the tool will be translated by the method of translation-back translation by greek and english native speakers. the study is designed as a prospective randomized crossover clinical trial. patients will be randomly allocated into two study groups. in group i the cpot tool is administered prior to a painful stimulus (itime0), during the painful stimulus (itime1) and soon afterwards (itime2).in group ii the cpot tool is administered prior to a non painful stimulus(iitime0), during a non-painful stimulus (iitime1) and soon afterwards (iitime2). after these trials the patients in the two groups will crossover into the other group and the whole process will be repeated. the painful stimulus is set to be the passive turning of the patient into the bed and the non painful stimulus is the cleaning of the arm or leg. 20 minutes afterwards the cpot tool is administered once again in both groups in order to obtain the values when there is no stimulus (itime3). the tool is administered by two trained members of the study team in a blind manner. both of the observers administer the tool at the same time but one of them is positioned in the ward of the patient and the other one behind a curtain with no contact with the observer but only with the patient and the monitor.

Eligibility criteria:
inclusion criteria: * patients admitted in the icu * age\> 18 years old * no hearing or visual deficit * no contraindication to body repositioning exclusion criteria: * patients with neurological deficit * patients administered with neuromuscular blocking agents * patients with motor or sensory deficits
laparoscopic surgery versus robot surgery for right-side colon cancer: short-term outcome of a randomised clinical trial

Conditions: Colon Cancer

Summary: the recent introduction of robotic surgical system has revolutionized the field of minimally invasive surgery. the investigators hypothesized that adoption of a robotic surgical system for patients with right-side colon cancer seems appealing because this system provides high-definition three-dimensional vision, eliminates physiologic tremor, and better ergonomics. this randomized controlled trial was designed to determine the safety and efficacy of robotic right hemicolectomy in comparison with laparoscopic right hemicolectomy.


Eligibility criteria:
inclusion criteria: * primary cancer * right-side located tumor (from cecum to proximal transverse colon) exclusion criteria: * tumor with obstruction * tumor with perforation * clinically advanced tumor (t4 stage) * tumor with distant metastases * synchronous tumor

Keywords: colon cancer robot laparoscopy primary, right-side colon cancer robot-assisted surgery
examining the spasmodic dysphonia diagnosis and assessment procedure (sd-dap) for measuring symptom change

Conditions: Spasmodic Dysphonia; Laryngeal Dystonia

Summary: this is a study of patients with spasmodic dysphonia to determine how best to measure the severity of the disorder in patients. it addresses which characteristics of speech are the best indicator of whether or not a particular treatment has benefited a person with spasmodic dysphonia. we hope to recruit 20 participants each at 2 different centers. the evaluation for each participant will be done on a two visits, one just before and another several weeks after treatment.

this is a study of changes in voice and laryngeal function with treatment recorded using the spasmodic dysphonia diagnosis and assessment procedure (sd-dap). persons with adductor spasmodic dysphonia will complete a questionnaire on the voice handicap index (vhi) and ratings of speech effort as well as have their speech recorded and receive a nasolaryngoscopy examination prior to their usual treatment with botulinum toxin injection into the laryngeal muscles for their voice disorder. they will return for re-examination several weeks later after their injection and repeat each of the examinations. the purpose is to determine which items on the sd-dap are sensitive to changes in the severity of their voice disorder. the items that show sensitivity would be those that would be useful for assessing voice outcomes in clinical trials. some of the questions this study is trying to answer are * what is the best way to measure the severity of spasmodic dysphonia? * how does treatment of spasmodic dysphonia by botulinum toxin injection affect voice for communication in regular daily life in spasmodic dysphonia * is change in speaking effort related to the change in severity of spasmodic dysphonia with botulinum toxin injection? each participant in this study will be asked to do the following: * provide a copy of medical records and medical history relating to the diagnosis of spasmodic dysphonia. * have an examination by an otolaryngologist with a medical periscope inserted in the throat to view the voice box in action. the examination will be so it can be reviewed later by several different experts. * complete questionnaires regarding the severity of their disorder before and after receiving their usual treatment; an injection of botulinum toxin into the laryngeal muscles. * repeat a speech recording and laryngeal examination before and after treatment

Eligibility criteria:
inclusion criteria: * be clinically diagnosed with primary spasmodic dysphonia (laryngeal dystonia) * be 18 years of age or older exclusion criteria: * be diagnosed with secondary spasmodic dysphonia (laryngeal dystonia) * be younger than 18 years of age * unable to complete questionnaires * not able to have a nasolaryngoscopy (examination of the voice box with a medical periscope)

Keywords: spasmodic dysphonia laryngeal dystonia dystonia severity
gsk bhr study (sont)

Conditions: Asthma

Summary: the purpose of this study was to determine whether asthma control and reduced bronchial hyperresponsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with advair diskus twice-daily or fp twice-daily in adult and adolescent subjects with persistent asthma


Eligibility criteria:
inclusion criteria: * asthma diagnosis * controller medications or moderate inhaled corticosteroid dose * evidence of reversibility exclusion criteria: * life-threatening asthma * asthma instability * concurrent respiratory disease * drug allergy * respiratory tract infection * systemic corticosteroid use * immunosuppressive medication use * positive pregnancy test * tobacco use * site affiliation
safety and tolerability of conversion from oral, injectable, or infusion disease modifying therapies to dose-titrated oral siponimod (mayzent) in advancing rms patients

Conditions: Multiple Sclerosis; Relapsing Multiple Sclerosis; Advancing Multiple Sclerosis

Summary: to assess safety and tolerability of patients converting from approved relapsing multiple sclerosis (rms) disease modifying therapies (dmts) to siponimod.

this is a 6-month, open-label, multi-center, single arm design, including advancing rms patients, evaluating the overall safety and tolerability profile of converting from oral, injectable or infusion rms dmts to oral siponimod.

Eligibility criteria:
key inclusion criteria: 1. signed informed consent. 2. male or female aged 18 to 65 years (inclusive). 3. patients with advancing rms as defined by the principal investigator. 4. prior history of relapsing ms (rms), with or without progressive features, according to the 2010 revised mcdonald or lublin criteria (lublin et al, 2013). 5. edss score of \>/= 2.0 to 6.5 (inclusive). 6. having been continuously treated with rms disease modifying therapies. key exclusion criteria: 1. pregnant or nursing (lactating) women. 2. patients with any medically unstable condition as determined by the investigator. 3. certain cardiac risk factors defined in the protocol 4. history of hypersensitivity to the study drug or to drugs of similar chemical classes. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: multiple sclerosis relapsing multiple sclerosis advancing multiple sclerosis conversion siponimod adult baf312 disease modifying therapies cognitive assessment open-label
invasive vs conservative strategies in non-st-elevation acute coronary syndrome and comorbidities

Conditions: Acute Coronary Syndrome

Summary: the guidelines of clinical practice, based on the randomized studies, recommend an invasive strategy in non-st elevation acute coronary syndrome (nsteacs). however, patients with comorbidities are excluded from the randomized studies and the observational registries showthat patients with comoribidities undergo fewer cardiac catheterizations. the aim is to investigate the benefit of the invasive strategy in patients with nsteacs and comorbidities. patients hospitalized with nsteacs, older than 70 years and with significant comorbidities, will be included. the latter will be defined as at least 2 of the following: peripheral artery disease, cerebral vascular disease, dementia, chronic pulmonary disease, chronic renal failure and anemia. the included patients will be randomized to an invasive (routine coronary angiogram) or conservative (coronary angiogram only if recurrent or inducible ischemia) strategy. all patients will receive medical treatment according to current recommendations. the main outcome will be death, reinfarction or readmissions by heart cause at one-year follow-up. the hypothesis is that an invasive strategy will improve prognosis in patients with nsteacs and comorbidities.


Eligibility criteria:
inclusion criteria: * age =\>70 years old * angina chest pain * troponin elevation * at least 2 of the following comorbidities: a) documented peripheral artery disease. b)renal filaure (gfr \ 2 or ambulatory oxigen therapy). anemia (hb =\<11 g/dl) exclusion criteria: * dynamic st changes (=\>1 mm) in the initial ecg * prior known non-revascularizable coronay disease * concomitant heart disease different to coronary disease * life expentancy \< 1 year

Keywords: non-st-elevation acute myocardial infarction comorbidities
evaluate the efficacy and safety of lmt1-48 on reducing body fat in overweight subject

Conditions: Overweight

Summary: the purpose of this study is to evaluate the safety and efficacy of lmt1-48(probiotics) compared to a placebo in reducing the body fat in overweight subjects


Eligibility criteria:
inclusion criteria: * age between 19 and 70 years * overweight (25 kg/m2 ≤ body mass index (bmi) \< 30 kg/m2) exclusion criteria: * pregnancy or breast-feeding * unstable body weight (body weight change \> 10% within 3 months before screening)
cardiac performance system data collection study - minnesota

Conditions: Cardiac Disease

Summary: non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

Eligibility criteria:
inclusion criteria: * ability to provide written informed consent * 22 years of age or older * referred for cardiac catheterization for reasons including heart failure, evaluation before transplant, pulmonary hypertension, shortness of breath, valvular disease, etc. exclusion criteria: * previous heart transplant * presence of left ventricular assist device * presence of a holter monitor or any other electrical leads on the chest at the time of sensor placement * surgical scars/wounds/bandages/ports at the site of sensor placement