Kornimate/medical-research-clean huggingface dataset:
safety and tolerability of indacaterol maleate/mometasone furoate delivered via the twisthaler® device after 14 days treatment in patients with mild to moderate asthma

Conditions: Asthma

Summary: this study will investigate the safety and tolerability of indacaterol maleate/mometasone furoate via the twisthaler device after 14 days treatment in patients with mild to moderate asthma.


Eligibility criteria:
inclusion criteria: * male and female adult patients aged 18-65 years (inclusive) * patients with mild-moderate asthma * forced expiratory volume in one second (fev1) at visits 1 and 2 are ≥60% of the predicted normal value for the patient. * body mass index (bmi) must be within the range of 18-32 kg/m\^2. * non-smokers or light smokers (≤10 cigarettes per day), with a smoking history of 10 pack years or less. exclusion criteria: * patients who suffer from chronic obstructive pulmonary disease (copd) * patients who have been hospitalized or had emergency treatment for an asthma attack in the 6 months prior to study start * qtcf interval \> 450 msec in men and \>470 msec in women * pregnant women or nursing mothers * females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception (surgical contraception or double barrier methods (to be continued for at least two months following last dose) are acceptable). * history of immunocompromise, including a positive human immunodeficiency virus (hiv) * a positive hepatitis b surface antigen (hbsag) or hepatitis c test result. * history of drug or alcohol abuse within 12 months of dosing other protocol-defined inclusion/exclusion criteria may apply.

Keywords: asthma spirometry lung function serum cortisol serum potassium plasma glucose
bioequivalence study of divalproex sodium 125 mg delayed release tablets under fasting conditions

Conditions: Seizures

Summary: the purpose of this study is to demonstrate the bioequivalence of divalproex sodium 125 mg delayed release tablets.


Eligibility criteria:
inclusion criteria: * no clinically significant findings on physical examination, medical history or laboratory tests on screening exclusion criteria: * positive test for hiv or hepatitis b and c * history of sensitivity to valproic acid or related compounds
incidence of peri-implant mucositis in patients with treated periodontitis

Conditions: Peri-implant Mucositis

Summary: the objective of this study is to determine the incidence of peri-implant mucositis in patients with treated periodontitis and enrolled in periodontal maintenance and to evaluate the associated risk indicators. an analytical prospective observational study will be carried out, with an initial follow-up of 12 months.

introduction: peri-implant mucositis (pm) is an inflammatory disease induced by the accumulation of bacteria (biofilm) around dental implants, which can be modulated by individual characteristics of the patient, as well as by numerous factors related to a greater accumulation of biofilm in peri-implant tissues. without correct regular maintenance, this entity can progress to peri-implantitis, a disease in which there is loss of bone supporting the implant. however, the strength of the association of the factors with the appearance of pm remains weak and incidence studies are limited due to their design and methodological inconsistencies. therefore, the objective of this study is to determine the incidence of pm in patients with treated periodontitis and enrolled in periodontal maintenance and to evaluate the associated risk indicators. material and method: an analytical prospective observational study will be carried out, with an initial follow-up of 12 months. patients with treated periodontitis and enrolled in periodontal maintenance will be selected, consecutively. they need to have implants placed in the periodontics specialist clinic and are going to be rehabilitated at the ucm school of dentistry. peri-implant and periodontal clinical records, radiographic records, demographic variables, patient-based variables, and submucosal microbiological samples will be taken on the day of crown placement and after 6 and 12 months. the calculation of the sample size estimates the need to recruit 227 patients. the results will be analyzed using regression models.

Eligibility criteria:
inclusion criteria: * over 18 years of age, able to comply with the protocol and comply with the established visits. * patients with treated periodontitis and enrolled in periodontal maintenance (last maintenance therapy received between 4 and 6 months maximum before inclusion in the study) (chapple et al., 2018, sanz et al., 2020). * patients with osseointegrated dental implants waiting for their prosthodontic rehabilitation (fixed prosthesis \[individual, partial or complete\], hybrid or overdenture). * physical or mental conditions that make it possible to perform appropiate oral hygiene exclusion criteria: * patients with untreated periodontitis. * totally edentulous patients. * patients with peri-implant diseases. * pregnant or in lactating-period patients. * patients undergoing treatment with medication that affects the periodontal/peri-implant status or the immune system (phenytoin, calcium antagonists, corticosteroids or anti-inflammatories). * patients who have taken antibiotics in the last month.

Keywords: peri-implant mucositis incidence biofilm periodontitis
efficacy and safety of valsartan versus placebo on exercise tolerance in patients with heart failure

Conditions: Diastolic Dysfunction, Symptomatic Heart Failure

Summary: this study will test the effects of valsartan versus placebo on exercise tolerance in patients with symptoms of heart failure


Eligibility criteria:
inclusion criteria: * symptomatic diastolic heart failure * breathlessness with physical exertion exclusion criteria: * uncontrolled hypertension * asthma, copd, or abnormal lung function * history of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm * liver, kidney, or pancreas disease * allergy to valsartan other protocol-defined exclusion criteria may apply

Keywords: diastolic dysfunction heart failure exercise tolerance valsartan
a study to evaluate the effect of ustekinumab on cytochrome p450 enzyme activities following induction and maintenance dosing in participants with active crohn's disease or ulcerative colitis

Conditions: Crohn Disease; Ulcerative Colitis

Summary: the purpose of this study is to evaluate the potential effects of an intravenous (iv) induction and subcutaneous (sc) maintenance administration of ustekinumab on the pharmacokinetic (pk) of a cocktail of representative probe substrates of cytochrome p450 (cyp) enzymes (cyp3a4, cyp2c9, cyp2c19, cyp2d6, and cyp1a2) in participants with active crohn's disease (cd) or ulcerative colitis (uc).


Eligibility criteria:
inclusion criteria for crohn's disease (cd) participants * participant must have a body weight in the range of 45 to 110 kilogram (kg) inclusive and have a body mass index (bmi) of 18 to 35 kilogram per meter square (kg/m\^2) inclusive * have had moderate to severe cd or fistulizing cd of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by histology, and/or endoscopy for healthy volunteers * healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ecg) performed at screening * healthy on the basis of clinical laboratory tests performed at screening and day-1 * if a woman of childbearing potential, she must have a negative serum beta-human chorionic gonadotropin (hcg) pregnancy test at screening; and a negative urine pregnancy test at day -1 exclusion criteria for cd participants * has complications of cd such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery in the next 3 months, could preclude the use of the crohn's disease activity index (cdai) to assess response to therapy, would possibly confound the ability to assess the effect of treatment with ustekinumab, or would alter the absorption of the probe cocktail * currently has or is suspected to have an abscess. recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks prior to baseline, or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery. participants with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses identified for healthy volunteers participants * has an abnormal c-reactive protein (crp) greater than (\>) 2\* upper limit of normal (uln) * has had major surgery (example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is in screening or is expected to participate in the study (5 weeks) * is pregnant, nursing, or planning a pregnancy (both men and women) during the study
a clinical trial for an evaluation of choline alfoscerate and donepezil for cognitive improvements of patients with cerebrovascular injury in alzheimer patients

Conditions: Alzheimer Disease

Summary: the purpose of this study is to evaluate efficacy and safety of choline alfoscerate and donepezil for cognitive improvements of patients with cerebrovascular injury in alzheimer patients


Eligibility criteria:
inclusion criteria: 1. 56\~90 male and female 2. mini-mental state evaluation (mmse) between 24 and 12 3. score ≥ 2 at the new rating scale for age-related white matter changes (arwmc), the rating scale of cerebral ischemic injury evaluated with mri 4. score 0.5, 1, 2 at cdr 5. presence of at least two of the following vascular risk factors: hypertension, diabetes, obesity, ischemic heart disease, dyslipidemia, hyperhomocysteinemia, smoking, previous cerebrovascular events and familiar history of cardio-cerebrovascular diseases. 6. donepezil 10mg from 3 months ago, dose not changed during clinical trials 7. a subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints exclusion criteria: 1. subjects allergic to or sensitive to the investigational product or applicable ingredients 2. subject who has taken below medication 1 month before screening 1) cholinesterase inhibitors 2) nmda receptor antagonists 3) blood circulation supplements 4) acetyl-l-carnitines 5) nicergoline 6) subject who has taken another medication that can affect the result of primary outcome 3. subject that can't be evaluated with adas-cog, mmse, npi, adl, cdr, attention questionnaire scale etc. 4. asthma, copd 5. decompensated heart disease 6. chronic renal failure or chronic liver disease 7. malignant tumor 8. subject that cant' be followed up for 12 months after investigational drug was taken. 9 subjects who are pregnant, lactating or who plan to be pregnant during the clinical period or females of child bearing years who do not use available contraceptive methods 10. subject who has taken other clinical or licensed medication from another clinical trial within 30 days prior screening period 11.other subjects who are deemed not to be appropriate for this clinical study in the discretion of investigator
study of mrtx1133 in patients with advanced solid tumors harboring a kras g12d mutation

Conditions: Solid Tumor; Advanced Solid Tumor; Non-small Cell Lung Cancer; Colo-rectal Cancer; Pancreatic Adenocarcinoma

Summary: a phase 1/2 study of mrtx1133 in solid tumors harboring a kras g12d mutation.

this first-in-human clinical trial will begin with an exploration of mrtx1133 dose and regimen. as potentially viable regimens are identified, phase 1b expansion cohorts may be implemented to ensure collection of sufficient safety and pk information, and early evidence of clinical activity are available to recommend phase 2 regimens. in phase 2, separate cohorts of patients by histological diagnosis and/or baseline characteristics will be evaluated for the clinical activity and efficacy of mrtx1133. this study was terminated prior to phase 2 initiating. only phase 1 of the study was conducted.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of a solid tumor malignancy harboring kras g12d mutation in tumor tissue or ctdna. * unresectable or metastatic disease. * patients must have received standard therapies appropriate for their tumor type and stage; first-line treatment for pdac for certain cohorts. * presence of tumor lesions to be evaluated per recist v1.1: 1. in the phase 1 dose escalation cohorts, patients must have measurable or evaluable disease. 2. in the phase 1b and phase 2 cohorts, patients must have measurable disease. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * adequate organ function. * age ≥ 18 years exclusion criteria: * active brain metastases or carcinomatous meningitis. * prior treatment with a kras g12d inhibitor (phase 1b \& phase 2 only). * history of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment. * history of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow oral medications. * history of malignant small bowel obstruction. * cardiac abnormalities.

Keywords: non-small cell lung cancer nsclc colorectal cancer crc pdac kras g12d solid tumor advanced solid tumor malignant pancreatic cancer pancreatic adenocarcinoma
otologic and rhinologic outcomes in children with clef palate

Conditions: Cleft Lip and Palate

Summary: objective: to compare otologic and rhinologic outcomes in patients with cleft palate according to surgical protocols and type of cleft. design: monocentric retrospective and prospective analysis of medical reports. patients, participants: all consecutively treated patients affected by a cleft palate, born between december 2006 and december 2009 and followed in the montpellier university hospital, at the age of 10 years. interventions: results of audiometry, tympanometry, otoscopy, tubomanometry and rhinomanometry and orofacial tomodensitometry done at the age of 10 were evaluated. main outcome measure(s): the history of ventilation tubes inserted, and the results at the edtq test were analyzed.


Eligibility criteria:
inclusion criteria : * 10 yo children with operated clefts followed in the universitary hospital of montpellier * who went to the ent check up exclusion criteria : * thoses who skip the check up

Keywords: cleft palate eustachian dysfunction obstructive ventilation
which markers of musculoskeletal health can explain complications in spinal surgery?

Conditions: Spine Injuries and Disorders

Summary: the present study is related to the project "orthospine fitness: which markers of musculoskeletal health can explain complications in spine surgery?", winner of the ministry of health call, financed by the european union, "m6/c2_call 2023", project code " pnrr- mcnt2-2023-12378098", call section "non-chronic chronic diseases transmissible diseases (mcnt2) with a high impact on health systems". complications of spinal surgery still represent a significant and unsolved problem. their incidence is between 7 and 20%, with a high percentage of mechanical complications observed in patients operated on for degenerative pathologies. readmissions, re-operations and subsequent rehabilitation treatments have a heavy impact on patients and the entire healthcare system.

the study proposed, financed through the "pnrr-mcnt2-2023-12378098" call, is a multicenter study on a large cohort of patients undergoing spinal surgery for degenerative pathologies of the thoraco-lumbar spine, which has as its general objective to establish a comprehensive preoperative screening of bone health and the musculoskeletal system, combining advanced imaging and modeling (hrpqct images of bone microstructure at peripheral sites and related computational assessment of bone mechanical properties), assessment of physical fragility (including muscle strength and assessment of proprioception/fall risk), cellular and molecular analyzes of bone fitness and bone-muscle cross-talk, and assessment of nutritional status. the results of the project will allow us to: (i) define a concept of "surgical suitability" to evaluate patients candidates for elective spinal surgery and possibly improve the surgical decision-making process (for example the choice of fixation and instrumentation); (ii) identify a minimum set of significant and independent markers to monitor in future interventional studies aimed at reducing the risk of adverse events in spinal surgery, (iii) allow patient-specific preoperative interventions (such as nutritional supplementation, physical pre-habilitation or administration of bone anabolic agents)

Eligibility criteria:
inclusion criteria: * age \>= 18 years; * diagnosis of degenerative pathology of the spinal column of the thoraco-lumbo-sacral tract; * patients candidates for surgical treatment for the aforementioned pathology during the study period; * willingness to participate in the study and sign the specific informed consent exclusion criteria: * presence of tumors or infections in the spinal column; * presence of degenerative pathology of the spine without surgical indication; * presence of degenerative pathology of the spinal column at the cervical level.

Keywords: spine surgery muscle strength physical fragility musculoskeletal system degenerative pathologies thoraco-lumbar spine
gait speeds and demands in chronic stroke patients: a multi-dimensional investigation

Conditions: Stroke

Summary: this study investigated the effect of treadmill walking training with and without random speed changes in persons in the chronic stage of stroke. it was hypothesized that random speed change group will show less attention and balance demands for speed change in level walking.

this study includes chronic stroke patients who will be randomly assigned to blocked or random walking speed change group to receive 30 min per session, 3 sessions per week for 2 weeks' walking training on a treadmill. the outcome measures include gait characteristics under 3 tasks x 3 speed conditions x 2 attention conditions on an obstacle-free walk way. the three tasks are normal walking, narrow based walking and obstacle crossing. the three speed conditions are constant (preferred) speed, speeding up (preferred to maximum speed), and slowing down (maximum to preferred speed). the two attention conditions are none and serial subtraction of 3 during walking. clinical sensorimotor function assessment, including hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and fugl-meyer lower extremity motor scale will be conducted for subject characterization.

Eligibility criteria:
inclusion criteria: * patients diagnosed with first stroke for at least 6 months * able to walk for at least 20 minutes independently without exhaustion * residual gait deficits * resting blood pressure is lower than 150/90 mmhg exclusion criteria: * unable to follow experimental instructions during the process * any pain, inflammation, or other neuromuscular or musculoskeletal conditions in the lower limbs that affect walking ability * unstable health problems

Keywords: stroke gait dual tasks motor learning
a trial of blunt needles for the reduction of needlestick injuries during cesarean section

Conditions: Glove Perforations; Needlestick Injuries

Summary: the objective of this study was to determine if blunt needle use during cesarean section closure protects against glove perforation and percutaneous injury to the surgeon and surgical assistant. a secondary objective was to determine physician satisfaction with blunt needles during the surgery.


Eligibility criteria:
inclusion criteria: * female * pregnant * undergoing a cesarean section exclusion criteria: * under age 18 * non-english speaking

Keywords: needlestick injuries glove perforations blunt needles glove perforations of surgeons, assistants needlestick injuries of same
playing avi during tennis training process

Conditions: Learning, Spatial; Cognitive Change

Summary: developing movement capabilities and efficiently acquiring and assimilating movement information and knowledge in middle childhood stages is of great importance for performing complex movement structures in later stages of life. our study is directed to researching the influence of active video games (avg) on assessment of tennis motor skills and visual capabilities in middle childhood, as a part of two separate sub-researches.

in the first sub-research, which included a sample of 55 children aged between 7 and 9, the investigators measured the physiological responses of bodies after acute and chronic exposure to playing avg. the investigators established a significant difference in skin conductance before beginning the intervention between the virtual and actual game. after the intervention, the experimental group had a significantly higher average value of heart rate frequency and breathing frequency while playing avg in comparison to the control group. in the second sub-research the investigators measured progress in tennis technique (trsc test), development of gross motor skills and change in reaction time on the same group of children. in the trsc test, the control group improved in all sub-groups with both strokes. the experimental group made no improvements in sub-group 3d with the ''forehand'', 1d and 3d with the ''backhand''. in the gross motor skill development test the investigators have not established a significant interaction effect. in the analogue reaction time measurement test, the investigators recorded a significant interaction between time x group. the same goes for simon's test with incongruent stimuli, with congruent the interaction was of no relevance. the investigators established that the use of avg can represent a new strategy for combining movement/sports activities and cognitively directed tasks aiming at effective assessment of tennis skills.

Eligibility criteria:
inclusion criteria: * age limit exclusion criteria: * excluded were players with injuries or long-term body impairments that prevented them from performing shots as they are usually instructed.

Keywords: stroke technique psychophysiological body responses visual perceptual skills reaction time.