Kornimate/medical-research-clean huggingface dataset:
therapeutic effect of luteolin natural extract versus its nanoparticles on tongue squamous cell carcinoma cell line

Conditions: Tongue Neoplasms; Carcinoma

Summary: in vitro study to examine whether luteolin and nano-luteolin exert an inhibitory effect on tongue squamous cell carcinoma cell line by inducing apoptosis, and to assess if nano-luteolin has more efficient apoptotic activity than luteolin on tongue squamous cell carcinoma cell line.

this study is conducted to examine whether luteolin and nano-luteolin exert an inhibitory effect on tongue squamous cell carcinoma cell line by inducing apoptosis, and to assess if nano-luteolin has more efficient apoptotic activity than luteolin on tongue squamous cell carcinoma cell line. the primary outcome is apoptosis, while the secondary outcome is cell viability.

Eligibility criteria:
inclusion criteria: * squamous cell carcinoma cell lines (oscc, tscc and hnscc). * luteolin 5,7,3',4'-tetrahydroxy-flavone (mesh term). * application of luteolin as a chemotherapeutic drug. exclusion criteria: * any cancer cell line other than oscc, tscc and hnscc cell lines. * luteolin glycosides.

Keywords: tscc oscc luteolin nanoluteolin nanotechnology oral cancer apoptosis pcr mtt elisa reader
dementia choirs for social and psychological wellbeing

Conditions: Dementia; Informal Caregivers (Family and Friends)

Summary: loneliness is common in both persons living with dementia and their informal caregivers, and a factor negatively affecting disease progression, health and wellbeing. however, intervention studies to address loneliness show inconsistent effects. this study aims to evaluate effect of a community-based group intervention - music therapy informed dementia choirs - on loneliness for home-dwelling people with dementia and their informal caregivers. we will recruit participants to five dementia choirs with 15-20 people in each and implement a crossover study with measures collected at four timepoints: baseline, 12-week follow up, 22-week follow-up after an extended summer holiday, and 12-week follow-up after the summer holiday. the primary outcome, loneliness in participants living with dementia, will be measured using the de jong gierveld loneliness scale. secondary outcomes will be depression, experience of meaning in life, apathy and mood for the participants living with dementia, and loneliness and caregiver burden for the informal caregivers. cognition in the participants living with dementia, measured with the rudas assessment tool, will be included as a control variable. further, measurements to evaluate the cost effectiveness of the choir intervention will be included, and qualitative data collected through semi-structured interviews to explore the experiences and possible impacts of the choir intervention in the participants' lives.


Eligibility criteria:
inclusion criteria: * dementia diagnosis (alzheimers, lewy-body, fronto-temporal, vascular, mixed, parkinson's dementia) or cognitive impairment as reported by the person themselves/their caregiver * informal caregiver of participant with dementia: a person who has a close relationship with a recruited choir participant living with dementia. a close relationship may for instance be a spouse/partner, sibling, adult child, friend, niece or nephew * living at home in the community exclusion criteria: * significant hearing impairment that is not resolved through the use of a hearing aid device and limit their capacity to enjoy musical experiences. * formal (paid) caregiver of participant with dementia

Keywords: dementia choir loneliness music therapy
comparison of cl wear between two allergy drops

Conditions: Allergic Conjunctivitis

Summary: comparison of two allergy drops for enhancing comfort and performance of contact lens wear

contact lens patients will instill allergy drops and subjective and objective tests will be performed

Eligibility criteria:
inclusion criteria: * males or females \> 18 years old * mild to moderate dry eye symptoms * likely to complete all study visits and able to provide informed consent exclusion criteria: * current use of topical cyclosporine * known contraindications to any study medication or ingredients * active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable) * ocular surgery within the past 3 months
stress ball use on anxiety

Conditions: Stress; Anxiety; Hemodialysis Complication

Summary: stress management in dialysis patients plays a key role in reducing these negativities and in maintaining both physical and mental well-being. in dialysis patients, on the other hand, the effectiveness of stress ball use on comfort and stress was evaluated, and no study was found that evaluated its effect on anxiety.

stress ball is one of the non-pharmacological methods used to distract individuals when they consciously focus on a stimulus. with the squeezing of the ball, the nerves in the hands are stimulated and stimuli are sent to the limbic region of the brain, and these stimuli provide an acupressure effect. at the same time, it is the easiest and cheapest method that allows the mind to get away from stress and maintain the mental well-being of the person.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * on maintenance hemodialysis three times per week for four hours per session * able to communicate in turkish * willing to participate to the study exclusion criteria: * having any health problems related to the hand/arm to use the stress ball * patients who did not want to participate in the study
mental health content and mental health outcomes

Conditions: Help-Seeking Behavior; Psych; Depression; Anxiety; Stress

Summary: the study will aim to explore the relationship between mental health content on social media and health behavior, addressing a gap in empirical research. using the theory of planned behavior, a survey with over 600 participants will examine associations between exposure to mental health content and behaviors like help-seeking and self-diagnosis.

background: mental health content has recently surged in popularity across social media. however, current empirical research lacks a comprehensive understanding of the relationship between mental health content and health behaviour. objective: this study will aim to address this gap by examining different types of mental health content and their relationship to behavior. specifically, it will explore whether exposure to mental health content will be associated with either positive behaviors, like help-seeking, or maladaptive ones, such as self-diagnosing. methods: utilizing the theory of planned behavior, a cross-sectional epidemiological survey will be conducted with over 600 participants to answer the research questions. baseline measures will include participants' exposure to various types of mental health content, and mental well-being (depression, anxiety, and scores from the dass-21). the outcome measures of interest will be help-seeking attitude (iasmhs) and self-diagnosing (self-i) behavior.

Eligibility criteria:
inclusion criteria: * enrollment is restricted to healthy adults between 21-34 (or 18-34 for university students) * use at least one social media platform (e.g., facebook, instagram, linkedin, x) * participants need to be able to read and understand english. * participants must also have lived in singapore for at least 2 years. exclusion criteria: * anyone who does not feel comfortable answering questions related to mental health and exposure to mental health-related content online.

Keywords: mental health content
the evaluation of a novel nasal mask for the treatment of obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: this investigation is a prospective, non randomized, non blinded study. this investigation is designed to evaluate the performance, comfort and ease of use with the f\&p trial nasal mask amongst obstructive sleep apnea (osa) patients.

visit 1 will involve the participants consented in to the trial. visit 2 will involve the participants being fitted with the f\&p trial nasal mask for use in-home. the participant will then come in to return the mask (visit three) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit two. the mask will be returned to the institution at the conclusion of the trial and the participant will return to their previous mask. the institution will recruit all patients within 1 week of the beginning of the study.

Eligibility criteria:
inclusion criteria: * adult (18+ years of age) * able to give consent * apnea hypopnea index (ahi)≥ 5 on diagnostic night * prescribed pap for osa * existing nasal mask user exclusion criteria: * inability to give consent * patients who are in a coma or a decreased level of consciousness * anatomical or physiological conditions making automatic positive airway pressure (apap) therapy inappropriate (e.g. unconsolidated facial structure) * commercial drivers who are investigated by new zealand transport agency * current diagnosis of carbon dioxide (co2) retention * pregnant or may think they are pregnant
comparison of oxygen controllers in preterm infants

Conditions: Premature Infant; Respiratory Insufficiency; Hypoxia; Hyperoxia

Summary: premature infants often receive respiratory support and supplemental oxygen for a prolonged period of time during their admission in the nicu. while maintaining the oxygen saturation within a narrow target range is important to prevent morbidity, manual oxygen titration can be very challenging. automatic titration by a controller has been proven to be more effective. however, to date the performance of different controllers has not been compared. the proposed randomized crossover trial comparing oxygen controllers in preterm infants (cockpit) is designed to compare the effect on time spent within target range. the results of this trial will help determining which algorithm is most successful in controlling oxygen, improve future developments in automated oxygen control and ultimately reduce the morbidity associated with hypoxemia and hyperoxemia.

both hypoxemia as hyperoxemia can potentially be harmful to premature infants. oxygen titration during respiratory support is vital to prevent these conditions but is very challenging. in the investigator's neonatal intensive care unit preterm infants routinely receive automatic oxygen titration performed by a controller. the currently used controllers are both proven to be more effective than manual titration, however which of the two controllers is most effective in keeping oxygen saturation within target range remains unclear. this randomized crossover trial tests tests both controllers within every study patient to determine which controller is most effective and thereby would hopefully reduce morbidity associated with hypoxemia and hyperoxemia the most. the primary outcome measure is the proportion of time spent within target range, each controller will be tested for 24 hours within the same study subject. this is excluding a 1-hour wash-out period after a change in ventilator. eligible infants are randomized to start with either the oxygenie algorithm or clio2 algorithm and will switch to the other study arm after 24 hours of measurement.

Eligibility criteria:
inclusion criteria: * preterm infants with a gestational age (ga) at birth of 24 - 29+6/7 weeks * receiving invasive mechanical ventilation or non-invasive respiratory support (ncpap or nippv) * receiving supplemental oxygen (defined as fio2 ≥ 0.25) at the time of enrollment and for at least 18 hours during the previous 24 hours; or a coefficient of variation in supplemental oxygen of ≥ 0.1 in the previous 24 hours. * expected to complete the 49-hour or 50-hour study period in the current form of respiratory support, i.e. invasive mechanical ventilation or non-invasive respiratory support * written informed parental consent must be present. exclusion criteria: * major congenital anomalies * arterial hypotension requiring vasopressor therapy within 48 hours prior to enrollment. * if the attending physician considers the infant not stable enough for a switch to another ventilator.
gram-negative bloodstream infection oral antibiotic therapy trial

Conditions: Gram-negative Bacteremia

Summary: the gram-negative bloodstream infection oral antibiotic therapy trial (the goat trial) is a multi-center, randomized clinical trial that hypothesizes that early transition to oral antibiotic therapy for the treatment of gram-negative bloodstream infection (gn-bsi) is as effective but safer than remaining on intravenous (iv) antibiotic therapy for the duration of treatment.

this is an open-label, pragmatic, randomized trial of approximately 1,204 adult patients hospitalized across 9 united states hospitals with the overarching goal of determining whether the optimal approach for the management of gn-bsi is (1) iv antibiotics for the duration of treatment or (2) initial iv antibiotics followed by early transition to oral antibiotics for the duration of treatment. patients will be randomized in a 1:1 ratio to remain on iv antibiotics or transition to oral antibiotics as soon as possible after blood culture collection, but no more than 5 days later. the primary objective is to compare the desirability of outcomes ranking (door) distributions between patients with gn-bsi receiving iv antibiotic treatment only versus patients transitioned early to oral antibiotic treatment. the study hypothesis is that oral treatment will result in a more favorable door distribution than iv treatment, likely as a result of differential adverse events and changes in quality of life (qol) profiles.

Eligibility criteria:
inclusion criteria: * adult (≥ 18 years) at the time of screening * hospitalized * identification of at least one gram-negative organism in a blood culture * capable of providing written informed consent (includes through a legally authorized representative) * willingness to adhere to assigned study arm * capable and willing to complete a follow-up qol interview (including through a legally authorized representative) exclusion criteria: * unable to tolerate or absorb a course of oral antibiotics * actively receiving vasopressors * gram-negative organism not susceptible to any oral antibiotics * gram-negative organism not susceptible to any iv antibiotics * polymicrobial bloodstream infection * the following patients with polymicrobial infections remain eligible for enrollment: (1) more than one morphology or species of a gram-negative organism (except for acinetobacter baumannii or stenotrophomonas maltophilia), (2) a single positive blood culture with a common commensal organism (grown in addition to an enterobacterales species or pseudomonas aeruginosa * allergy or contraindication rendering no oral option or no iv option for therapy with the listed antibiotic agents. * anticipated duration of therapy greater than 14 days * central nervous system infection * absolute neutrophil count of \<500 cells/ml or anticipated to reduce to \<500 cells/ml during the antibiotic treatment course. * receiving hospice care

Keywords: gram-negative bacteremia antibiotic treatment antibiotic route escherichia coli pseudomonas aeruginosa klebsiella pneumoniae desirability of outcome ranking (door)
polysomnography study of gsk1838262 extended release tablets versus placebo in rls and associated sleep disturbance

Conditions: Restless Legs Syndrome; Restless Legs Syndrome (RLS)

Summary: the purpose of this study is to assess the efficacy and safety of gsk1838262 extended release tablets in the treatment of patients with restless legs syndrome and associated sleep disturbance.

double-blind, multi-center, placebo-controlled, 2-period crossover study which assessed the efficacy and safety of gabapentin enacarbil (gen; gsk1838262; xp13512) extended release tablets in adults with restless legs syndrome (rls)-associated sleep disturbance. one hundred thirty-six (136) adult subjects with rls-associated sleep disturbance and periodic limb movements (plm) were randomized from 23 centers in the united states. subjects who met all eligibility criteria were randomized to receive a treatment sequence of gen:placebo or placebo:gen. investigational product was taken with food at approximately 5pm. investigational product was dosed as 600mg/day x3 days followed by 1200mg/day x25 days for each 4-week treatment period. there was a 1-week taper at 600mg after each treatment period followed by a 1-week washout between treatments. polysomnography (psg) was used to objectively evaluate changes in sleep and plms.

Eligibility criteria:
inclusion criteria: * provided written informed consent. * diagnosed with primary rls using the international rls study group diagnostic criteria with a total score of 15 or greater on the international rls (irls) rating scale and significant sleep disturbance indicated on item 4 of the irls rating scale. * have history of rls symptoms at least 15 nights/month. * minimum average of 15 periodic limb movements during sleep per hour (measured using actigraphy). exclusion criteria: * secondary rls * primary sleep disorder * sleep apnea * have any medical conditions that may impact efficacy assessments or that may present a safety concern. * pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control. * use of any prohibited medication.

Keywords: psg restless legs syndrome gabapentin enacarbil xp13512 gsk1838262 sleep disturbance rls polysomnography
safety study extension of iloprost power 15 in pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: patients with symptomatic idiopathic (ipah) or familial (fpah) pulmonary arterial hypertension in new york heart association (nyha) class ii to iv , naive to pah treatment or currently being treated with a stable dose of either bosentan or sildenafil and who complete prowess 15 will be enrolled in the prowess 15 extension study. this is a double-blind (12 week), randomized study to compare the safety and tolerability of inhaled iloprost power disc-15 and power disc-6 in patients with symptomatic pulmonary arterial hypertension (pah). after completion of the double blind period, patients will be entered in the open label period using iloprost power disc-15.


Eligibility criteria:
inclusion criteria: 1. signed informed consent prior to initiation of any study mandated procedure, 2. patients with symptomatic idiopathic or familial pulmonary arterial hypertension in nyha functional class ii to iv who have completed study ac-063a301, 3. women of childbearing potential must have a negative urine pregnancy test and must use an adequate method of contraception during the study and for 28 days after discontinuation of the study drug. exclusion criteria: 1. pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria, 2. pulmonary arterial hypertension associated with significant venous or capillary involvement (pulmonary capillary wedge pressure (pcwp) \> 15 mmhg), known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis, 3. moderate to severe obstructive lung disease: forced expiratory volume in 1 second/forced vital capacity (fev1/fvc) \< 70% and fev1 \< 65% of predicted value after bronchodilator administration, 4. moderate to severe restrictive lung disease: total lung capacity (tlc) \< 60% of predicted value, 5. pregnant or breast-feeding women, 6. systemic hypertension (systolic blood pressure \> 160 mmhg or diastolic blood pressure \> 100 mmhg on repeated measurement), 7. systolic blood pressure \< 95 mmhg, 8. moderate to severe hepatic impairment, i.e., child-pugh class b or c, 9. chronic renal insufficiency defined by serum creatinine \> 2.5 mg/dl (221 μmol/l) or ongoing dialysis, 10. clinically relevant bleeding disorder or active bleeding, 11. known hypersensitivity to iloprost or any of its excipients.

Keywords: pulmonary arterial hypertension inhaled treatment inhalation solution iloprost ventavis
dose escalation study assessing the safety and immune response of ppv-06 vaccine

Conditions: Knee Osteoarthritis

Summary: ppv-06 immunotherapy targets interleukin-6 (il-6), a key molecule of the immune system whose overproduction is implicated in many inflammatory and autoimmune diseases such as rheumatoid arthritis and osteoarthritis. the benefit of vaccination with ppv-06 is to induce, in response to immunizations, the production of antibodies directed against il-6. the antibodies produced will neutralize the biological activity of il-6 involved in the body's inflammatory process. the primary objective is to evaluate the safety/tolerability of vaccination with ppv-06.


Eligibility criteria:
inclusion criteria: 1. male or female aged over 40 years; 2. diagnosis of primary inflammatory knee osteoarthritis (koa), 3. body mass index (bmi) of 18-32 kg/m2 at screening; 4. patients with normal organ function at baseline 5. contraceptives measures 6. in the investigator's opinion, the patient is capable and willing to comply with the requirements of the study; 7. willing and able to sign a written informed consent; 8. affiliated to social security insurance. exclusion criteria: 1. systemic autoimmune or immunodeficiency disease; 2. administration of non-steroidal anti-inflammatory drug (nsaid): 3. administration of prednisone or having intra-articular corticosteroid injection or bolus intramuscular or intravenous treatment with corticosteroids; 4. patients treated with biologics such as anti-tnfalpha, anti-il-6 and anti-cd-20 5. participation in another investigational drug or vaccine trial; 6. knee surgery planned before screening and throughout the study; 7. knee surgery within the year of baseline; 8. knee trauma within 2 months of baseline; 9. chronic hepatitis b and/or c infection. patients with previous infection, resolved in the past, are eligible; 10. hiv-positivity; 11. history of allergic reaction to any constituents of the study drug; 12. diagnosis or history of any inflammatory arthritis; 13. neurologic disorders involving the lower limbs; 14. history of malignancy within the last 5 years; 15. uncontrolled congestive heart failure or hypertension, unstable heart disease 16. evidence of any clinically significant abnormality on a chest x-ray which, in the opinion of the investigator, could represent active infection or latent tuberculosis; 17. moderate or severe acute illness/infection, persistent diarrhea or vomiting on the day of vaccination; 18. received any licensed, non-live vaccine within the 14 days before receipt of any dose of the study vaccine or is scheduled to receive any licensed, non-live vaccine within 30 days following receipt of any dose of the study vaccine; 19. receipt of immune globulins, blood or blood-derived products; 20. pregnant or lactating females; 21. the investigator considers the patient unfit for the study as a result of the medical interview, physical examination, or screening investigations.