Kornimate/medical-research-clean huggingface dataset:
the effect of supraglottic and oropharyngeal decontamination on the incidence of ventilator-associated pneumonia

Conditions: Trauma Injury; Brain Injuries; Abdominal Sepsis; Pancreatitis; Meningitis; Encephalitis; Seizures; Acute Respiratory Distress Syndrome

Summary: oropharynx is the main source of pathogen microorganisms for the ventilator - associated pneumoniae. as known bacteriophages can eliminate different pathogen microorganisms or reduce a degree of a pathogen's colonization. the research team is considering that oropharyngeal decontamination with bacteriophages can prevent the developing of the ventilator - associated pneumoniae. there will be three groups in this investigation: placebo, antiseptic drug (octenisept) and bacteriophage (sexthaphag).


Eligibility criteria:
inclusion criteria: - invasive mechanical ventilation beyond 48 hours exclusion criteria: * hospital - acquired pneumonia * community - acquired pneumoniae * bmi \> 35 kg/cm2 * pregnancy * tracheostomy * reintubation
manual ankle therapy on fear of falls, range of motion, and functionality and stability in geriatric patients

Conditions: Old Age; Atrophy

Summary: the range of movement of the ankle decreases with age and the plantar arch decreases, adopting a more pronated position of the foot. the main objective is to analyze the effectiveness of manual therapy using ankle joint techniques in geriatric patients. randomized, double-blind clinical trial with follow-up period. subjects will be assigned to control and experimental groups using a data analysis tool (excel). the dependent variable will be the fear of falls. the secondary variables will be the range of movement in dorsiflexion of the ankle, and the functionality and stability of the lower limbs. three evaluations will be carried out. a baseline measurement before the start of the study (t0), after the intervention (t1) and after a 3-week follow-up period (t2). a manual therapy protocol will be carried out, lasting 3 weeks with 1 weekly session. each session will last 10 minutes. the patients included in the experimental group will undergo the following manual therapy techniques: talus dorsal sliding technique and joint technique in "8" on the lisfranc and chopart joints. the patients included in the control group underwent the same techniques as those indicated for the experimental group, but without sliding or placing joint tension. the periodicity and times of administration will be the same


Eligibility criteria:
inclusion criteria: * subjects older than 65 years * subjects of both sexes * with impaired balance and gait * with joint limitation of ankle dorsiflexion * with established functionality or stability deficits (for example, who need third parties or technical aids to walk (crutches)) exclusion criteria: * people with cognitive impairment that prevents their collaboration in the intervention and the different evaluations * people with inability to stand * people who have not given their written consent.
comparison of different screening score for hypoxemic osa (obstructive sleep apnea) with the results of a polysomnography (psg)

Conditions: Sleep Apnea, Obstructive

Summary: comparison of different screening score for hypoxemic osa (obstructive sleep apnea) with the results of a polysomnography (psg). the different screening score studied are: stop-bang, des-osa, p-sap and osa50.

the investigators should compare the four screening scores (stop-bang, des-osa, p-sap and osa50) with the results of the psg (and in particular the number of apnea and hypopnea index and the probability of hypoxemia).

Eligibility criteria:
inclusion criteria: * adults patients (\> 18 years) exclusion criteria: * none
caregiver burden within the ambulatory extended recovery (axr) patient population

Conditions: Caregiver Burden

Summary: the purpose of this study is to understand the level of caregiver burden related to caring for a patient who goes home within the first 24 hours following surgery. as the caregiver they are providing care to a family member, friend, or neighbor. even when not formally trained, the care they provide is important to the patient's recovery. providing care in this manner can be stressful. this study will help us understand what aspects of the patient's recovery are most difficult for the caregiver.


Eligibility criteria:
inclusion criteria: * caregiver/patient pairs undergoing surgery for an indication tracked within the breast, gynecology, head and neck, and urology axr program * english speaking * patients willing to provide demographic, surgical, and outcome information * caregivers willing to provide demographic, socioeconomic, and caregiver experience information * caregivers willing to complete the caregiver burden measurement scales exclusion criteria: * patients undergoing surgery within the axr pathway that do not have a caregiver * non-english speaking patients or caregivers * patients unwilling to provide demographic and surgical information * caregivers unwilling to provide demographic, socioeconomic, or caregiver experience information or unwilling to complete the caregiver burden measurement scales

Keywords: quality of life patient care givers 15-145 ambulatory extended recovery
pharmacokinetic study comparing salmeterol/fluticasone easyhaler products and seretide diskus

Conditions: Asthma

Summary: the purposes of this study is to compare the test products salmeterol/fluticasone easyhaler with marketed product seretide diskus in terms of the drug absorbed into the blood stream


Eligibility criteria:
inclusion criteria: * written informed consent obtained * good general health ascertained by detailed medical history, and laboratory and physical examinations exclusion criteria: * evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gi, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years * any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. as an exception, paracetamol and ibuprofen for occasional pain are allowed * known hypersensitivity to the active substance(s) or the excipient (lactose, which contains small amounts of milk protein) of the drug * pregnant or lactating females
the cerebral-respiratory interaction in controlled mechanically ventilated neurosurgical patients. (the ceres-cmv study)

Conditions: Mechanical Ventilation Complication; Neurological Disorder; Lung Injury

Summary: the impact of mechanical ventilation on intracranial perfusion is still not completely clarified. it is often assumed that raising airway pressure will invariably elevate the intracranial pressure, but this is not always the case. the effects of airway pressure on intracranial pressure can depend on several factors, and among others, an uncontrolled expiration and consequent lung collapse may have an influence on cerebral perfusion. this study will investigate the incidence and the consequences of an uncontrolled expiration and expiratory lung collapse in critically ill neurosurgical patients during controlled mechanical ventilation. electrical impedance tomography measurements , oesophagus and gastric pressure, electrical activity of the diaphragm and intracranial pressure will be acquired in a synchronised manner during controlled mechanical ventilation. moreover, airway opening pressure, expiratory flow limitation and recruitment/inflation ratio will be determined during controlled mechanical ventilation, on a daily bases until the patient recover his/her own spontaneous breathing.


Eligibility criteria:
the patients will be included within 48 hours from initiation of mechanical ventilation and insertion of an external ventricular drainage catheter inclusion criteria: * age \>18 years; * mv expected for more than 72 hours; * not pregnant; * informed consent from patient or next of kin. exclusion criteria: * previously demonstrated paralysis of the diaphragm or know pathology of the phrenic nerve or neuromuscular disorder, * chest tube, * patients with clinical conditions that contraindicate the insertion of esophageal/gastric catheters (e.g., esophagus rupture, esophageal bleeding), * pacemaker and/or implantable cardioverter defibrillator, these last being a contraindication for eit. * hemicraniectomy. in case of late hemicraniectomy (after patient inclusion), the patient will drop-out from the study. relative contraindication: in case of skull base fracture the patient can be included only if oesophageal/gastric and nava catheters can be inserted orally.
intraindividual variability in sleep and cognitive performance in older adults

Conditions: Insomnia Chronic

Summary: the proposed study will examine changes in older insomniacs' cognitive functioning following behavioral treatment for insomnia using a combination of two methods. a traditional repeated measures design will be used to look at group level differences based on performance on a neuropsychological battery administered prior to, immediately after, and 3 months after completing a 4 week behavioral treatment program for insomnia. this data will be analyzed using standard repeated measures analytic techniques. a time-series design will also be used to look at within-subject differences based on a brief cognitive battery that will be self-administered on a daily basis. data from this daily battery will be examined using intraindividual variability modeling.


Eligibility criteria:
inclusion criteria: * age \>65 years * community dwelling * available for duration of study * insomnia according to american sleep disorders association (1990) criteria: (a) \>30 minutes of unwanted awake time, 3 nights per week for at least 6 months and (b) daytime dysfunction (reported mood, cognitive, social, or occupational impairment) exclusion criteria: * age less than 65 * history of primary sleep disorder (e.g., sleep apnea, narcolepsy) * history of stroke * major medical illness known to contribute to sleep problems in last 12 months * cognitive impairment that interferes with ability to understand treatment (score \<23 on mini-mental state examination)
18f-fmiso pet guided dose escalation in nasopharyngeal carcinoma - a feasibility and planning study

Conditions: Nasopharyngeal Carcinoma

Summary: this study aims to investigate the use of 18f-fmiso pet in identifying hypoxic subvolume for dose escalation radiotherapy in nasopharyngeal cancer and thus improve local control without significant increase in toxicities.

the specific aims of this study are: 1. to establish hypoxia imaging in npc patients 2. investigate the dynamics of tumor hypoxia before and during chemoradiation 3. integrate hypoxia imaging into radiation treatment planning protocols 4. design hypoxia adapted radiation schedules 5. identify candidate hypoxia biomarkers

Eligibility criteria:
inclusion criteria: * t3-t4 disease with no evidence of distant metastasis. * histological diagnosis of who type ii or iii npc * no evidence of distant metastases in staging work up (including lung, liver and bone imaging). * planned for upfront radiotherapy and/or chemotherapy. * cross sectional imaging of the primary and neck disease (mri preferred) * performance status of ecog grade 0 or 1 * no prior tumour therapy * at least 21 years of age, of either sex. * negative serum pregnancy test within 14 days prior to registration for women of childbearing potential; * adequate bone marrow, renal and hepatic function defined as follows: bone marrow: wbc \> 3000 / mm3 (anc \> 1500 / mm3 ) platelets \> 100 000 / mm3. hb \> 10 gm/dl renal: serum creatinine within institutional normal range(or) lower than the lower limit of institutional normal range : calculated creatinine clearance \> 50 ml / min hepatic: enzymes (sap, sgot) \< 2x normal: bilirubin \< 24 mol / l. exclusion criteria: * allergic to 18f-fluoromisonidazole or nitroimidazoles * planned for neoadjuvant chemotherapy * uncontrolled hypercalcaemia: calcium 2.7 mmol/l (10.8 mg/dl). * other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator). * have serious active infection. * pregnant or lactating female subjects and subjects with reproductive potential not implementing adequate contraceptive measures

Keywords: hypoxia fmiso pet nasopharyngeal cancer
a 10-week study evaluating the efficacy and safety of pd 0332334 for the treatment of generalized anxiety disorder

Conditions: Generalized Anxiety Disorder

Summary: this study will evaluate the efficacy and safety of pd 0332334 for the treatment of generalized anxiety disorder.


Eligibility criteria:
inclusion criteria: * diagnosis of gad (diagnostic and statistical manual-iv \[dsm-iv\], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the mini international neuropsychiatric interview (mini) for dsm-iv axis i disorders and other clinical information. subjects with specific phobia(s) (as defined in dsm-iv) or dysthymic disorder will be allowed in the study. * subjects must have a ham-a total score ≥20 at the screening (v1) and randomization (v2) visits. subjects must also have a covi anxiety scale score of \>9 and a raskin depression scale score \<7 at the screening (v1) visit to ensure predominance of anxiety symptoms over depression symptoms. exclusion criteria: * subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, neurologic, active infections, immunological, or allergic disease (including drug allergies). * any of the following current (within the past 6 months through the present) dsm-iv axis i diagnoses: major depressive disorder, obsessive compulsive disorder, panic disorder; agoraphobia, posttraumatic stress disorder, anorexia, bulimia, caffeine-induced anxiety disorder, alcohol or substance abuse or dependence unless in full remission for at least 6 months, social anxiety disorder. * any of the following past or current dsm iv axis i diagnoses: schizophrenia, psychotic disorder, delirium, dementia, amnestic, and other clinically significant cognitive disorders, bipolar or schizoaffective disorder, cyclothymic disorder, dissociative disorders. * antisocial or borderline personality disorder. * serious suicidal risk per the clinical investigator's judgment.
fib to alb ratio in type 2 dkd

Conditions: CKD; Type 2 Diabetes

Summary: aimed to investigate the association of fibrinogen to albumin ratio (far) with dkd type 2 and to prove its possible role as a novel biomarker to predict and prevent dkd progression.

diabetic kidney disease (dkd) is the most prevalent chronic kidney disease. around 3540% of patients with type 2 diabetes mellitus (t2dm) will go on to develop dkd. dkd is characterized by albuminuria and reduced estimated glomerular filtration rate (egfr), both of which are independent risk factors for end-stage kidney disease (eskd), cardiovascular events, and death. dkd accounts for a significant increase in mortality among diabetic patients and is a grave threat to their clinical outcome. inflammation plays a major role in the development of dkd. serum fibrinogen (fib) is a biomarker of coagulation and inflammation. elevated serum fib is an independent risk factor of dkd progression to eskd in patients with t2dm. albumin (alb) has anti-inflammatory functions and antioxidant properties. hypoalbuminemia is associated with a poorer renal prognosis in patients with t2dm and dkd. fibrinogen to albumin ratio (far) is a more significant prognostic marker than each single marker itself in cancer study.

Eligibility criteria:
inclusion criteria: * age above 18 yrs. * 50 pts with type 2 dm that have dkd (presence of albuminuria in association with diabetic retinopathy) and 50 pts with type 2 dm but have no dkd. exclusion criteria: * age below 18 yrs. * pts with eskd, manifested cardiac valvular disease, acute infection, history of hepatitis, pts with dka and cancer. * pt who refused to contribute in this study
effects of respiratory training on respiratory and functional performance in patients with stroke

Conditions: Stroke

Summary: the purpose of the research is to investigate the effects of respiratory training on respiratory and functional performance in patients with stroke.

stroke ranks third in the global cause of death, behind cancer and coronary heart disease. stroke is also the third largest cause of death in taiwan in 2014. stroke patients in the course of exercise are in addition to muscle weakness and reduced endurance, but usually also accompanied by respiratory damage. from past studies have shown that stroke patients whose respiratory function has significant change, such as decreased respiratory muscle strength, reduced respiratory movement of the affected hemithorax, declined in maximum breathing pressure and decreased amplitude of diaphragmatic movements on the paralyzed side. but whether respiratory training can improve respiratory and functional performance of stroke patients, because of the limited research results could not be confirmed.

Eligibility criteria:
inclusion criteria: * first episode of unilateral stroke. * the definition of stroke was according to the world health organization (who) criteria (hatano 1976), confirmed by computerized tomography (ct) or magnetic resonance imaging (mri). * older than 20 years. * had maximum inspiratory pressure (mip) values lower than 90% of those predicted and adjusted for age and sex. * facial palsy, which could not prevent proper labial occlusion. * ability to understand and follow simple verbal instructions. * no receptive aphasia. * not undergone thoracic or abdominal surgery. exclusion criteria: * unable to perform the tests. * impaired level of consciousness and evidence of gross cognitive impairment. * excluded patients with comorbidities of respiratory system disease (e.g. chronic obstructive pulmonary disease, asthma, cystic fibrosis), or other diseases leading to the impairment of respiratory muscle (e.g. myasthenia gravis).

Keywords: respiratory training functional performance
ocular fluorophotometry for glaucoma treated with cyclo-coagulation using high intensity focused ultrasound (hifu).

Conditions: Refractory Open Angle Glaucoma

Summary: monocentric prospective study conducted in two phases evaluating the secretion and elimination of aqueous humor by fluorophotometry in patients with glaucoma treated with cyclo-coagulation with ultrasound. population selected: - patients with refractory open angle glaucoma despite previous treatments currently validated for glaucoma. the purpose of our study is: - to evaluate the mechanism of action of glaucoma treatment by cyclo-coagulation with high intensity focused ultrasound in studying the secretion and elimination of aqueous humor by fluorophotometry. planning: * first phase: 2 patients (feasibility study) if reduction of at least 10% of the flow of aqueous humor production at one month in the first two patients in the feasibility study, further in second phase. * second phase: 6 patients

main outcome criteria: reduction of aqueous humor flow at 6 months compared with the pretreatment of aqueous humor flow.

Eligibility criteria:
inclusion criteria: * refractory primary open-angle glaucoma (poag) * iop\> 21 mm hg and \<32 mm hg with an optimal treatment. * lack of history of cyclo-destruction of the ciliary body (laser diode, cold ...) * lack of intraocular surgery or laser therapy in the eye seen in the three months preceding the date of hifu treatment. * male or female age (s) of at least 18 and able to give informed consent * patient who signed the informed consent form * patient affiliated to a social security scheme exclusion criteria: * history of glaucoma by placing a drainage implant (valves, pipes ...) * previous refractive procedures preventing accurate measurement of intraocular pressure (prk, lasik) * general treatment which may alter iop began in the month before the hifu procedure * patient monophthalmus * thyroid orbitopathy * history of ocular or retrobulbar tumor * cyclodialysis * choroidal hematoma or uprising choroidal * anatomy of the eyeball inadequate treatment or medical device (eye too small or too large) * pregnancy, breastfeeding, lack of contraceptive use among women at risk of having a child * participation in another clinical investigation of a medical or surgical treatment can affect the intraocular pressure in the three months preceding the hifu * patient minor or major protected by law

Keywords: glaucoma high intensity focused ultrasound aqueous humor fluorophotometry
golimumab in steroid-dependent ulcerative colitis: induction and maintenance of clinical and endoscopic remission

Conditions: Colitis, Ulcerative

Summary: this is an open-label, phase iv trial. adult patients, with moderately to severe, steroid dependent, acute ulcerative colitis not previously exposed to anti-tnf, will receive subcutaneous golimumab treatment, according to eu marketing authorization from baseline through week 14. at week 16, patients achieving clinical and endoscopic remission will continue with golimumab, 50 mg or 100 mg (depending on body weight) every 4 weeks, through week 52. patients not achieving clinical and endoscopic remission will be treated with infliximab, according to marketing authorization, and followed through week 52. this is not considered as an interventional arm but, since infliximab in italy is considered as the first-line treatment for uc patients, as the usual clinical practice.


Eligibility criteria:
inclusion criteria: * patients aged 18-65 years * ability to understand the study procedures and sign the informed consent * ulcerative colitis diagnosed at least 6 months before * no previous exposure to anti-tnfs * global mayo score ≥ 6 (with endoscopic sub-score ≥2) at baseline * steroid-dependent disease * women of childbearing potential must accept effective contraception during study participation and for at leas 6 months after the end of study participation exclusion criteria: * crohn's disease or undetermined colitis * active infections or previous infections not completely resolved at baseline * malignancies in the previous 5 years * suspected latent tuberculosis infection * every other potentially harmful clinical condition, in the opinion of the investigator * patients with moderately to severe heart failure (nyha class iii/iv) * hepatic or renal failure * pregnant or lactating women or women planning a pregnancy between baseline and the 3 months after study completion * not permitted concomitant medications

Keywords: golimumab ulcerative colitis steroid-dependent
a study to evaluate the safety and effectiveness of a digital therapeutic

Conditions: Suicide, Attempted; Suicidal Ideation

Summary: the primary objective of this study is to assess the effectiveness of a digital intervention in reducing suicide attempts.

this double blind, randomized controlled trial will evaluate effectiveness of two digital interventions among 391 participants. study participation will start when participants sign consent. participants and research assessors will be blinded to treatment assignment.

Eligibility criteria:
inclusion criteria: 1. ages ≥18 years old 2. patients recently hospitalized. 3. owns a smartphone. 4. willing and able to complete enrollment procedures. 5. able to understand the nature of the study. 6. able and willing to provide at least two verifiable contacts. exclusion criteria: 1. patients who have untreated psychosis or active psychosis 2. patients who appear to be impaired by the use of alcohol or other substance(s) 3. patients who sign, or have signed, an informed consent form to participate in any clinical research 4. patients who upon clinical examination are cognitively impaired 5. patients with a medical condition that may compromise, interfere, limit, effect or reduce the subject's ability to complete