Kornimate/medical-research-clean huggingface dataset:
assessing choice in the employer setting (aces) study

Conditions: Healthy

Summary: the purpose of this study is to determine, among adults and in the total population, the effects of offering a choice of flumist or trivalent inactivated vaccine (tiv) in the employer setting when compared to a control group.

the primary objective is to determine, among adults in the 18-49 year old population and in the total population, the effects of offering a choice of flumist or tiv with and without enhanced advertisement/added incentive on the overall influenza vaccination rates in the employer setting when compared to a control group.

Eligibility criteria:
inclusion criteria for employer sites: * located in the united states * has not previously offered flumist in an employee vaccination program in the past or flumist represented less than 5% of all vaccine received at past programs * data are available that will allow for a reliable estimate of the employee (total and 18-49 year old populations) vaccination rate for the 2007-2008 influenza season

Keywords: flumist, tiv, vaccination rates
photobiomodulation therapy plus m-health in head and neck cancer patients: laxer study

Conditions: Head and Neck Cancer; Head and Neck Neoplasms; Xerostomia

Summary: the photobiomodulation therapy could have positive effects on quality of life and oral health in head and neck cancer survivors post-radiotherapy. the improvement in quality of life will be maintained after a follow-up period.

many experts advocate the use of photobiomodulation (pbm) therapy in patients with cancer and demand studies of higher methodological quality such as randomized controlled clinical trials. however, there is no consensus on the most effective dosimetry that allows us to establish an effective and safe approach to treat radiotherapy-induced xerostomia in head and neck cancer survivors. finally, recent reviews highlight the importance of determining whether or not the effects of photobiomodulation therapy are maintained after a follow-up period.

Eligibility criteria:
patients will be included in the study if they meet the following inclusion criteria: * men or women aged 18 years or older and were diagnosed with hnc. * chronic xerostomia. * received rt in the parotid, submandibular and/or sublingual salivary glands. * grade 3 oral dryness according to the common terminology criteria for adverse events version 5.0 (ctcae). * medical treatment completed and in complete remission. * received medical clearance for participation in this study. * at least one month passed since the end of rt to avoid the possible presence of oral mucositis and/or radiodermatitis, which limits adherence to treatment and maximum 36 months. * no history of drugs/devices/products (pilocarpine, cevimeline, amifostine, oral devices, humidifiers, or herbs) to prevent or treat xerostomia prior to study inclusion or no change in their use (no change in type or dose) for two months prior to study inclusion. * and able to access mobile applications or living with someone who has this ability. the exclusion criteria will be as follows: * patients with metastases. * a score \<60 on the karnofsky performance status scale. * contraindications to receiving pbm therapy (e.g., cardiac arrhythmias, pacemakers, photosensitivity, drugs with photosensitizing action, and pregnancy). * other comorbidities such as diabetes and polypharmacy. * and retraction of the declaration of consent.

Keywords: quality of life neoplasms xerostomia low-level light therapy telemedicine
a study to determine the efficacy and safety of tigecycline compared with imipenem/cliastatin to treat complicated intra-abdominal infection

Conditions: Intra-abdominal Infection

Summary: this is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin in hospitalized patients with a complicated intra-abdominal infection.


Eligibility criteria:
inclusion criteria: * hospitalized male or female subjects, at least 18 year of age. * complicated intra-abdominal infection is present at most under two weeks duration. * minimal clinical criteria at the time of intra-abdominal infection diagnosis or highly suspected intra-abdominal infection. exclusion criteria: * anticipated length of antibiotic therapy less than 5 days or the likelihood that the subject will not complete the course of treatment. * intra-abdominal infection known to be caused by 1 or more bacterial pathogens not susceptible to both of the study drugs. * had accepted non-study antibiotics more than 24 hr within 72 hrs before enrollment except for subjects declared prior failures.
efficacy of formulated posterior sub tenon triamcinolone in macular edema secondary to non-ischemic retinal vein occlusions

Conditions: Retinal Vein Occlusion

Summary: retinal vein occlusion (rvo) is considered the second vascular disorder of the retina after diabetic retinopathy. patients with rvo are at risk of the development of macular edema. different treatment modalities for macular edema include laser therapy, antivascular endothelial growth factor (vegf), and triamcinolone. aim to detect the efficacy of formulated triamcinolone acetonide(ta) injection in the posterior subtenon space to manage macular edema secondary to non-ischemic rvos, either central or branch.


Eligibility criteria:
inclusion criteria: * diminution of vision due to macular edema secondary to non-ischemic retinal vein occlusions, either central or branch * cmt ≥ 250 µ, * willing to participate in the study. exclusion criteria: * unwilling to participate in the study * ischemic rvo * previous laser treatment * glaucoma, macular ischemia, cataract, vitreous hemorrhage, and neovascularization of the iris * patients with previous anti vegfs or steroid injections or any eye surgery three months before the inclusion * cardiac co-morbidities result in significant hemodynamic changes * respiratory diseases need treatment with antibiotics * suffering from other chronic diseases as diabetes * patient with allergy from triamcinolone acetonide.
study to assess exs21546 in combination in patients with advanced solid tumours

Conditions: Advanced Solid Tumours

Summary: a phase 1b/2a study to assess the safety, tolerability, pharmacokinetic and anti-tumoral activity of exs21546 in combination with a pd-1 inhibitor in patients with advanced solid tumours.

a phase 1b/2a study to assess the safety, tolerability, pharmacokinetic and anti-tumoral activity of exs21546 in combination with a pd-1 inhibitor, nivolumab, in patients with advanced solid tumours, non small cell lung cancer and renal cell carcinoma.

Eligibility criteria:
inclusion criteria: * aged ≥ 18 years at time of informed consent. * previous histologically confirmed diagnosis of rcc or nsclc having received previously checkpoint inhibitors as part of a soc regimen. * consent to mandatory paired tumour biopsies of at least one tumour site accessible for repeat biopsies. planned sites for tumour biopsies must not have been previously irradiated and could be a target lesion of \>2 cm diameter according to recist v1.1 and must be approved on a case-by-case basis by the sponsor. * measurable disease as per recist v1.1 and documented by computed tomography (ct) and/or magnetic resonance imaging (mri). exclusion criteria: * any anti-tumour therapy, including investigational therapies, within 4 weeks prior to the first dose of exs21546. * unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy, i.e., ≥ grade 2 per ctcae v5.0. * concurrent other malignancy that could interfere with response evaluation. * symptomatic central nervous system (cns) malignancy or metastases. screening of symptomatic participants without history of cns metastases is not required. participants with asymptomatic cns lesions should have completed standard therapy for their cns lesions 60 days prior to study enrolment. * history of interstitial lung disease and/or prior immunotherapy-related pneumonitis. * patients who have had or are scheduled to have major surgery \< 28 days prior to the first dose of study drug.
can an actigraph be used to predict physical function in intensive care patients?

Conditions: Critical Illness; Quality of Life; Physical Activity

Summary: this study aims to investigate whether an actigraph, measuring in-hospital activity, used for a week after discharge from the icu at zealand university hospital køge, can predict physical function at three-month follow up. the hospital activity will be measured with actigraphy, a measurement tool that quantifies activity level. the activity will be measured for 7 days after icu discharge. the actigraph is to be worn as a bracelet. the physical function will be measured with chelsea critical care physical assessment tool (cpax). cpax is assessed at icu discharge and after three months.

treatment at an intensive care unit (icu) is often needed for the survival of critically ill patients, but it can take a long time to recover. a number of high quality studies have shown that patients experience functional impairments for a long period after discharge, even for years. these patients may suffer from a number of other negative influences of their critical illness and icu stay, e.g. memory problems, episodes of depression, cognitive dysfunction and sleeping disorders. these symptoms are seen in both medical and surgical patients and has been named the post intensive care syndrome. physical rehabilitation is important and must start already during admission, in order to regain some of the function and independence of the patients. this has a well documented effect on both mental and physical wellbeing. actigraphy is a newer way of quantifying the activity level continuously. it is validated and has been used in the icu to assess agitation and sedation and in an oncological, surgical and even an icu population to assess sleep. it is easy to use, non-invasive and inexpensive. it is worn like a bracelet and doesn't impair the patients mobility or ambulation. another issue when evaluating physical impairments is the choice of method for assessing physical function. for this study, the investigators use the chelsea critical care physical assessment tool (cpax) as it has good validity and clinimetric properties and is easy to use. also, it can be done as part of the daily training as it is developed specifically for the icu. the aim of this study is to investigate how the in-hospital activity level of patients after icu discharge is associated with their physical function at three months post discharge.

Eligibility criteria:
inclusion criteria: * patients \> 18 years of age * admitted to the icu for \> 24 h exclusion criteria: * not able to speak and understand danish * patients suffering from dementia or psychosis * discharged from the icu to terminal care * patients transferred to another hospital during icu stay * patients living outside the region of zealand * patients suffering from total paralysis before admission
effect of ultrasound-guided transversus abdominis plane block after laparoscopic bariatric surgery

Conditions: Postoperative Nausea and Vomiting; Postoperative Pain

Summary: to explore and compare ultrasound-guided transversus abdominis plane block on postoperative nausea and vomiting and early outcome after laparoscopic bariatric surgery to evaluate and examine tapb can reduce the application of intraoperative and postoperative opioids and the duration of analgesia

poor postoperative nausea and vomiting control is a leading factor that hinders the physical rehabilitation, and causes acute cognitive impairment and chronic pain syndrome. recently, the multimodal analgesia strategies to minimise opioid-related side effects are highly desirable in open surgical procedures. the transversus abdominis plane block is a novel technique involving injection of local anaesthetic between the internal oblique and the transversus abdominis muscles of the abdominal wall. although ropivacaine is most commonly used for this technique, the analgesic duration remains not dissatisfied. herein, investigators will evaluate the efficacy of ultrasound-guided transversus abdominis plane(usg- tap) block with ropivacaine in laparoscopic bariatric surgery.

Eligibility criteria:
inclusion criteria: 1. subject is scheduled to undergo laparoscopic bariatric surgery 2. subject's american society of anesthesiologists physical status is i-iii. 3. bmi\>35kg/m2 4. the subject's parent/legally authorized guardian has given written informed consent to participate exclusion criteria: 1. subject has a diagnosis of renal or liver failure. 2. subject has a diagnosis of mental illness 3. subject is allergy and contraindication to ropivacaine. 4. subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery. 5. subject has any contraindication for the use 6. subject is pregnant or breast-feeding.

Keywords: ropivacaine transversus abdominis plane block opioid consumption dexamethasone
fluoxetine in pulmonary arterial hypertension (pah) trial

Conditions: Pulmonary Arterial Hypertension

Summary: this protocol describes an open-label phase 2 clinical trial of fluoxetine in pah looking at change in pulmonary vascular resistance (pvr) as the primary endpoint. in this open-label clinical trial, 18 patients with pulmonary arterial hypertension will be given fluoxetine for 24 weeks. a right heart catheterization will be performed at baseline and 24 weeks. change in pvr will be the primary endpoint; other hemodynamic endpoints, quality of life, qids-sr depression scale, functional class and six-minute walk distance will also be evaluated. primary hypothesis: fluoxetine treatment for 24 weeks will lead to significantly lower pulmonary vascular resistance in 18 patients with pah in patients treated in an open-label clinical trial.


Eligibility criteria:
inclusion criteria: 1. who group i pah subtypes of idiopathic pah and pah associated with drugs / toxins, connective tissue disease, repaired congenital heart disease and unrepaired atrial septal defect 2. age 16-80 3. who functional class ii or iii 4. right heart catheterization within 3 weeks of study entry with mpap ≥ 25 mmhg, wedge ≤ 15 mmhg, and pvr ≥ 3 wood units. 5. contraception use, (-) urine pregnancy test, not breast feeding (women of childbearing potential) 6. one or more approved pah therapies for ≥ 3 months, no change in dose for 1 month (endothelin-1 antagonist, phosphodiesterase-5 inhibitor, prostacyclin / prostacyclin analog). novel approved therapies in one of the three existing classes will also be acceptable as background therapy if they become available during the course of the study; other medication classes are excluded exclusion criteria: 7. who functional class iv or listed for lung transplant 8. moderate or greater obstructive lung disease: fev1/fvc \<70% and fev1 \<60% 9. moderate or greater restrictive lung disease: tlc or fvc \<60% (if 50-60%: ok if tlc or fvc ≥50% + pft stable x1 year + ct with no more than mild lung disease) 10. other cause for pulmonary hypertension: all other who group i diseases (including but not limited to liver disease, hiv), and who groups ii-v (i.e. left heart disease, lung disease, chronic pe and miscellaneous causes)24. 1. high probability vq or positive cta 2. left ventricular ejection fraction \<40% 11. depression 12. severe liver, renal or other medical or physical disease preventing completion of the study procedures 13. use of antidepressants within 3 months
relaxahead for headache patients (phase iii)

Conditions: Migraine

Summary: this study is a fully powered, remote randomized control trial to evaluate relaxahead in people with migraine.

patients with migraine seen across diverse primary care practices (through three different affiliated hospitals and one of the largest family health center groups in the country) will be identified via an electronic medical record system. the investigators will randomize 356 participants and examine the potential benefits to two different smartphone based interventions between baseline and weeks 3-6. the investigators will also examine the persistence of effects up to 26 weeks post-treatment, mediators to explore mechanisms, and moderators to identify subgroups of patients for whom the intervention seems most effective.

Eligibility criteria:
inclusion criteria: * english speaking. (at this time, the validated app is only available in english.) * ≥16 years of age * meets international classification of headache disorder (ichd)-3 migraine criteria based on information in the study manual * headaches for ≥1 year with a stable pattern for the past \>3 months * agreement to not make any preventive medication changes for the 3 months before the start of the trial and then the 6 weeks of the intervention part of the study * 4-29 headache days a month (so that we include those in whom we typically offer preventive treatment (\>4 headache days/month and those with more frequent migraines including chronic migraine but exclude those with continuous headaches (30 days/month)) * msqv2 score \<75 for role restrictive function to ensure participants have sufficient reduced quality of life to potentially benefit from the intervention (see if there is a positive effect of the intervention) exclusion criteria: * patients who have had cbt, biofeedback, or other relaxation therapy for migraine in the past year * alcohol or other substance abuse as determined by self-report or prior documentation in the medical record * diagnosis of medication overuse headache and/or opioid or barbiturate use * phq-8 scores greater than 15, indicate a conservative score of moderately severe depressive symptoms based on the phq-9 12-14 (in those with phq-8 scores \>15, more intense intervention targeted to the depression may be needed, as depression is a significant predictor of migraine chronification and people with migraine and comorbid depression are more likely to be refractory to migraine treatments and to suffer from medication overuse) * unable or unwilling to follow a treatment program that relies on written and audio-taped materials * not having a smartphone (we do not believe this exclusion criterion will adversely affect equitable subject selection because the subject population specific to our research question would only be able to access this application via smartphone if it were to become publicly available, including subjects without smartphones would not be pertinent to our research question and overall study goals). * pregnant (because hormonal fluctuations in pregnancy can affect migraine outcomes)

Keywords: migraine smartphone app headache diary headache tracking
to study the association among labor pain and physical parameters in laboring pregnant women

Conditions: Labor Pain

Summary: analysis of monitored clinically parameters during the course of labor is a seldom studied area in taiwan and worldwide. important monitored parameters include, fetal heartbeat, uterine contractions, oxygen saturation and blood pressure, among others.1 during labor, uterine contractions can cause pain.3 this pain may be measured using a visual analogue scale (vas).2 the pain from uterine contractions promotes the release of hormones including cortisol which can cause decreased or irregular contractions and possibly prolong labor.3 this study aims to study the association between monitored clinical parameters and pain in women in taiwan during labor in order to increase the understanding to safe childbirth.

this is a prospective, observational study to measure and collect and physical parameters from females at least 20 years of age in the labor room. collection of measurements and physical parameters will begin when the subject enrolls in the study. besides, ecg and spo2 will be recorded continuously until the end of the study period. in addition, uterus contraction cycle and fetal heart beat will be recorded during the study period based on standard of care in the labor room. pain will be recorded on a visual analogue scale (vas) at baseline and when the caregiver perceives that there is a change in the subject's pain status until the end of the study period. the time of each assessment of pain on vas should be recorded. subjects will be withdrawn from the study if they have a cesarean section or any complication during labor in the opinion of the investigator. subject participation in the study will end when eight hours have elapsed since baseline, the subject leaves the labor room or the subject delivers the baby.

Eligibility criteria:
inclusion criteria: 1. female at least 20 years of age. 2. have a course of labor that is \> 4 hours. 3. american society of anesthesiologists physical status (asa ps) classification of class i-ii. 4. clinical records of the subject are complete in the opinion of the investigator. exclusion criteria: 1. subject has any condition, which in the opinion of the investigator precludes the subject's participation in the study.

Keywords: labor pain
shared decision making for choosing autosomal dominant polycystic kidney disease treatment

Conditions: ADPKD (autosomal Dominant Polycystic Kidney Disease)

Summary: the purpose of this study is to generate clinical evidence and assess the feasibility of a shared decision-making (sdm) model for the selection of tolvaptan in patients with adpkd.

autosomal dominant polycystic kidney disease (adpkd) patients, eligible to taking tolvaptan, have to decide whether to take tolvaptan regarding critical factors such as water intake, side effects, and their personal values and preferences. our study aims to develop and validate a shared decision-making (sdm) model for adpkd patients considering tolvaptan therapy. the sdm model we developed include a patient decision aid, educational materials and self-monitoring tools, all provided by a mobile application. this model was built to deliver enough knowledge and considerations during a decision-making process, which would be helpful for patients to reach a decision on tolvaptan. through the multi-center hybrid randomized controlled trial, the model's effectiveness and feasibility will be evaluated. improvements in treatment outcomes, patient satisfaction, adherence, and quality of life are anticipated. this study can propose a structured, patient-centered framework for therapeutic decision-making in adpkd patients.

Eligibility criteria:
inclusion criteria: * participants between the age of 18 to 80 * participants with a diagnosis with ckd stage 2 or 3 * participants with a diagnosis with adpkd classified as 1c, 1d, or 1e according to mayo classification * participants with the ability to communicate and use digital devices * participants with no severe visual impairment and cognitive dysfunction exclusion criteria: * participants who were previously exposured to tolvaptan * participants who are contraindicated to tolvaptan * participants who were judged ineligible by the investigator

Keywords: autosomal dominant polycystic kidney disease shared decision making hybrid randomized controlled trial type 1 tolvaptan
effect of hyoscine and promethazine on labor pain

Conditions: Labor Pain

Summary: it is always considered to shorten the duration of delivery without compromising the mother and fetus by obstetrics. hyoscine and promethazine are used widely in hospital and research is very limited, with conflicting results regarding the efficacy of these two drugs. so the investigators decided to compare of effect of hyoscine n-butyl bromide and promethazine on length of active phase of the first stage of labor.


Eligibility criteria:
inclusion criteria: * 18-35 yrs, * primiparous, * having single fetus with cephalic presentation, gestational age 37-42 weeks, * having no medical diseases, * having no history of hospitalization due to psychological diseases, * having no addiction to cigarette, * having no complications during pregnancy such as hypertension, * bmi\< 26 exclusion criteria: * bleeding * cpd * use of pg or oxytocin * fetus distress

Keywords: hyoscine, promethazine, the first stage of labor, labor pain