Kornimate/medical-research-clean huggingface dataset:
prospective evaluation of endoswir device versus pathology for squamous cell carcinoma of upper aerodigestive tract (endoswir-vads)

Conditions: Head and Neck Neoplasms

Summary: a new medical optical device named endoswir is tested to determine its ability to determine if tissues are cancer or normal tissue on ex-vivo condition for specimen of ent squamous cell cancers.

in vivo short infrared imaging is a real-time, sensitive technique that can be used in the operating room during surgical removal of tumors. it is essential in the surgery of cancers of the upper aerodigestive tract to be in healthy margins in order to avoid heavier surgical resumption or complementary treatments such as radiotherapy. the optical imaging device in the short infrared range called endoswir and tested on tonsil samples has shown its safety on the analysis of tissues and seems to be promising for the detection of tumor tissues or, on the contrary, their absence in the resection margins (animal studies). the principal objective is to determine the ability of the endoswir dm-div to distinguish healthy tissue from tumor tissue on an ent squamous cell carcinoma specimen by concordance rate (in %) between the endoswir result and the final pathology examination of each tissue portion of a subject (8 per subject).. secondary objectives are : to demonstrate that analysis of a sample using the endoswir device is faster than extemporaneous analysis, the safety of swir. an ancillary analysis of areas of particular interest such as resection margins or carcinoma in situ/dysplasia areas etc...

Eligibility criteria:
inclusion criteria: * ent cancer (buccal or oropharyngeal) for which a surgical resection is planned * affiliated to the social security * having given his non-opposition to participate in the trial. exclusion criteria: * patient protected by law (minor, pregnant or breastfeeding woman, patient under guardianship, subject deprived of liberty or hospitalized under restraint). * patients who have received radiotherapy treatment in the vads area * patient with a history of vads cancer or a synchronous location of vads cancer.

Keywords: head and neck neoplasms fluorescence short wave infra-red
combined therapy with l-thyroxine and l-triiodothyronine compared to l-thyroxine alone

Conditions: Hypothyroidism

Summary: the objective of this study was to analyze the features of monotherapy with l-t4 in comparison with combined therapy with l-t4 and l-t3 in patients with primary hypothyroidism.

we conducted a randomized controlled study with a crossover design in 36 premenopausal women with overt primary hypothyroidism (reduced t4 concentration accompanied by increased tsh concentration at the time of initial diagnosis) who did not receive thyroid hormones. all patients were divided into two groups: patients from group a (n=20) were randomized to l-t4 in dose of 1,6 μg per kg, followed by combined l-t4 and l-t3; and 16 women from group b received the combination of l-t4+l-t3 (the dose of l-t4 was reduced by 25 μg and replaced with 12,5 μg of l-t3), followed by monotherapy with l-t4. the treatment periods lasted for 6 months. patients were examined at baseline and at the end of each treatment period.blood samples were obtained to measure serum tsh, free t4, free t3, lipid profile, osteocalcin. urine samples were collected to measure urinary deoxypyridinoline / creatinine ratio. 24-hour ecg-monitoring, osteodensitometry and psychological testing were also performed at baseline and at the end of each treatment period.

Eligibility criteria:
inclusion criteria: * premenopausal women with overt primary hypothyroidism (reduced t4 concentration accompanied by increased tsh concentration at the time of initial diagnosis) who did not receive thyroid hormones exclusion criteria: * peri- and postmenopause * pregnancy * major comorbidity * use of drugs that affect metabolism or bioavailability of thyroid hormones preparations.

Keywords: hypothyroidism, treatment, thyroxine, triiodothyronine
efficacy of novel edible gel-based artificial saliva in thai geriatric populations with systemic diseases

Conditions: Xerostomia; Hypertension; Diabetes Mellitus

Summary: elderly people usually have systemic diseases and take medications that can cause dry mouth. the purpose of this study is to determine whether continuous use of edible, gel-based artificial saliva in geriatric population with dry mouth problems will reduce signs and symptoms of dry mouth and improve quality of patients' saliva.

a pre-post test trial was conducted in 120 elders with xerostomia. all subjects received a total of 50 ml (10ml x 5 times) omj per day. subjective and objective dry mouth scores, salivary ph, buffering capacity and satisfaction were monitored at 2 weeks and 1 month use, compared to baseline. the data were analyzed by repeated measure anova.

Eligibility criteria:
inclusion criteria: * have systemic diseases such as hypertension or diabetes mellitus and take medications that can cause dry mouth * report symptoms of dry mouth exclusion criteria: * subjects with uncontrolled systemic diseases * subjects who aspirate upon eating * subjects who smoke * subjects who are allergic to component of the intervention

Keywords: saliva substitute edible gel xerostomia diabetes mellitus hypertension
gp2013 treatment in patients with active rheumatoid arthritis, previously treated with rituxan® or mabthera®

Conditions: Rheumatoid Arthritis

Summary: the study objective is to identify potential safety risks of the transition from us-licensed rituxan® or eu-approved mabthera® to gp2013 (proposed biosimilar product) as compared to continuous treatment with the originator product in terms of general safety and immunogenicity.


Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis (ra) according to acr 2010 criteria * completed one full treatment course with either rituxan® or mabthera® * eligible for a further treatment course with rituxan® or mabthera®- currently treated with methotrexate exclusion criteria: * ra functional status class iv (acr 1991 revised criteria) * systemic manifestation of ra * positive serology for hepatitis b or hepatitis c infection * active systemic infection * history of cancer * known severely immunocompromised state other protocol-defined inclusion/exclusion criteria may apply
influence of an osteopathic treatment protocol on the improvement of sleep quality in young adults with insomnia

Conditions: Healthy

Summary: sleep deprivation, which is a universal necessity, has serious physiological consequences. sleep disorders are among the most common health problems, and yet they are often neglected. the osteopathic treatment results in vasodilation, muscle relaxation and increased blood flow, resulting in improved range of motion, decreased pain perception and/or tissue changes. thus, osteopathy ensures improved physical and mental health, which consequently helps patients with their sleep disorders.

humans spend about a third of their lives sleeping, but most individuals know little about sleep. sleep deprivation, which is a universal necessity, has serious physiological consequences. based on behavioral and physiological criteria, human sleep is divided into two phases: non rapid eye movement (nrem) and rapid eye movement (rem). nrem sleep corresponds to 75% to 80% of sleep and rem approximately 20% to 25% of sleep, existing between four to six episodes. sleep disorders are among the most common health problems, and yet they are often neglected. it is estimated that millions of people suffer chronically from a sleep or wakefulness disorder, impairing their health and longevity. according to the international classification of sleep disorders (icsd) there are eight categories of sleep disorders and clinical history is essential for diagnosis, including family history, medical, psychiatric, neurological or substance abuse disorders. insomnia is a sleep disorder defined by difficulty falling asleep, staying asleep, or both. it can cause significant distress and impair daily tasks. the symptoms of insomnia are expressed by having difficulty falling asleep, waking up frequently during the night, waking up very early on a daily basis, and tiredness already present upon waking up. osteopathic treatment results in vasodilation, muscle relaxation and increased blood flow, resulting in improved range of motion, decreased pain perception and/or tissue changes (henley, ivins, mills, wen, \& benjamin, 2008). thus, osteopathy ensures improved physical and mental health, which consequently helps patients with their sleep disorders.

Eligibility criteria:
inclusion criteria: * have sleep disorders (insomnia); * volunteers between 18 and 30 years of age. exclusion criteria: * attending the 3rd or 4th year of the osteopathy course; * present fever (axillary or oral temperature higher than 37.5º c); * have a history of skull fracture; * have a history of bleeding and intracranial hemorrhage; * have a diagnosis of convulsion.

Keywords: osteopathy insomnia sleep disorder
change-a multi-center chronic thromboembolic pulmonary hypertension （cteph） database in china

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Summary: the change database is a prospective, observational multi-center disease registry, which will collect data on patients with chronic thromboembolic pulmonary hypertension (cteph) in china. it aims to illustrate the epidemiology, management and long-term outcomes of cteph.

18 cteph centers will be enrolled in the study. the epidemiology, diagnosis，treatments (pulmonary endarterectomy (pea), balloon pulmonary angioplasty (bpa) and targeted medical therapy), and long-term prognosis of cteph will be evaluated.

Eligibility criteria:
inclusion criteria: 1. patients must be diagnosed with chronic thromboembolic pulmonary hypertension (cteph) 2. patients must be willing to provide informed consent 3. patients must meet the following criteria for cteph: a mean pulmonary artery pressures (mpap) ≥20 mmhg combined with a pulmonary vascular resistance (pvr) ≥ 3 wu and pulmonary arterial wedge pressure (pawp)≤ 15 mmhg documented at right heart catheterization with radiographic evidence of organized thrombi involving the pulmonary arteries after 3 months of effective anticoagulation. exclusion criteria: 1. main cause of ph other than cteph 2. participation in a therapeutic clinical trial with an unknown drug; 3. withdrawal or lack of informed consent.

Keywords: chronic thromboembolic pulmonary hypertension epidemiology diagnosis treatment prognosis balloon pulmonary angioplasty pulmonary endarterectomy
hypoalbuminemia in mild acute stroke and cognitive impariment post-stroke

Conditions: Cognitive Impairment; Stroke; Albumin; Double

Summary: this registration enrolled patients with acute ischemic stroke within 72 hours after stroke ictus. patients was identified as first-ever stroke based on past medical histrory. admission ct was conducted to exclude hemorrhagic stroke, but not those bleeding transformation after ischemia injury. baseline characteristics, including demographics, vascular risk factors, lab tests and neuroimagings were collected. patients were followed up for cognitive assessments.

this is a perspective stroke registry cohort study. stroke patients were included if ：(1) acute first-ever ischemic stroke and admitted within 72 hours after onset; (2) clinical stroke diagnosis was confirmed with positive diffusion-weighted magnetic resonance imaging (dw-mri), those with isolated posterior circulations infarcts were exclude ; (3) presented with mild stroke severity ( admission nihss score ≤5); (4) age between 40 and 80 years. clinical data including demographic characteristics, risk factors, and baseline nihss score were assessed and collected using a standardized table by experienced neurologists. lab tests were performed with fasting venous blood samples within 18 hours of admission. patients were followed up for 6 months. the cognitive functions were assessed using the chinese version of montreal cognitive assessment (moca). contributing factors to post-stroke cognitive impariment (psci) were determined by comparing clinical data between psci and non-psci groups. all potential confounders were introduced into the multivariate regression models.

Eligibility criteria:
inclusion criteria: 1. acute first-ever ischemic stroke and admitted within 72 hours after onset; 2. clinical stroke diagnosis was confirmed with positive diffusion-weighted magnetic resonance imaging (dw-mri), those with isolated posterior circulations infarcts were exclude ; 3. presented with mild stroke severity ( admission nihss score ≤5); 4. age between 40 and 80 years. exclusion criteria: 1. patients with index cognitive impairment or under current anti-dementia or psychiatric medication; 2. patients with large infarcts (≥1/3 middle cerebral artery territory); 3. patients with severe language or physical disability that impede neuropsychological testing; 4. patients with recurrent transient ischemic attack (tia)/stroke during follow-up; 5. coexisting serious conditions known to impair cognitive function
comparison of the efficacy of transcranial direct current stimulation (tdcs) of the primary motor cortex (m1) or the prefrontal cortex combined with aerobic activity for alleviation of fibromyalgia symptoms.

Conditions: Fibromyalgia; Electric Shock

Summary: the goal of this study is to demonstrate the effectiveness of treating fibromyalgia using combination of electrical stimulation with aerobic activity. participants will be randomly assigned to stimulation in a ratio of 1:1:1. 120 participants (40 in each group). the therapeutic course will include moderate aerobic physical activity (at 60% of the target heart rate adjusted for age) 3 times a week for 4 weeks (a week of adjustment, and 3 weeks of treatment), along with low current electrical stimulation for 3 weeks.

fibromyalgia is a disorder of unknown origin that causes widespread pain, fatigue, sleep disorders, cognitive disorders, depression and anxiety. today, the treatments for fibromyalgia are limited in their effectiveness in most cases. previous works have demonstrated that the self-regulation ability among those dealing with fibromyalgia is impaired, and their quality of life is poor. therapy using low current electrical stimulation is considered an effective, safe and non-invasive means of treating various disorders including treatment of depression, neurological rehabilitation and various pain syndromes. a number of works have demonstrated the effectiveness of treating fibromyalgia using stimulation using low electrical current , and it has also been demonstrated that a combination of electrical stimulation with aerobic activity improved the results, together with each of the treatments separately. there are several areas that can be stimulated including the primary motor area (m1) and the prefrontal area , however, the studies performed were limited to a relatively small number of subjects, and no direct comparison was made between the different stimulation locations. for the study, male and female patients dealing with fibromyalgia will be recruited from the hospital clinics or those who will be referred by the attending physician, or will respond to recruitment notices, in total we intend to recruit 120 participants (40 in each group). the patients will be randomly assigned to real stimulation for each of the areas or to blood stimulation in a ratio of 1:1:1. the therapeutic course will include moderate aerobic physical activity (at 60% of the target heart rate adjusted for age) 3 times a week for 4 weeks (a week of adjustment, and 3 weeks of treatment), along with low current electrical stimulation for 3 weeks.

Eligibility criteria:
inclusion criteria: * diagnosed fibromyalgia * pain scale level of 4 or higher * fail to achieve adequate pain relief with fibromyalgia treatments * stable fibromyalgia treatment for at least 4 weeks. * ability to perform aerobic exercise exclusion criteria: * other causes of pain * psychotic disorder * severe depression * cognitive disorder * drug or alcohol abuse in the last 6 months * pregnancy
structuring financial incentives to increase physical activity

Conditions: Physical Activity; Weight Loss

Summary: the purpose of this study is to evaluate the effectiveness of different structures of long term financial incentives on increasing physical activity performed by subjects, as measured by the number of steps walked per day. investigators are interested in studying whether physical activity increases during an intervention period (with incentives) and a post-intervention period (with no incentives).

the proposed study is a field experiment. adults within the ages of 25 and 60 years of age, and with a body mass index of 22 or higher will be eligible to participate. the study will consist of (1) a two-week baseline period, (2) a 36-week intervention period, and (3) a 12-week follow-up period. at the beginning of the study, subjects will be given a wearable fitness device and their daily step count will be monitored for two weeks; this is the baseline period. after the two-week baseline period, the subjects will be randomly assigned to one of the five different conditions (control, gain, loss, gain streak, or loss streak) and will be given the goal to increase their baseline step counts by 2,500 steps. ===== hypotheses -- investigators expect the following: 1. loss aversion: subjects in the loss treatment will achieve the goal on a greater number of days than subjects in the gain treatment. 2. streak: subjects in the gain treatment will achieve the goal on a greater number of days than subjects in the gain streak treatment. 3. loss streak: subjects in the loss treatment will achieve the goal on a greater number of days than subjects in the loss streak treatment. whether subjects in the loss streak treatment will perform better or worse than subjects in the other two treatments will be investigated. contribution -- prior research has not examined the effect of a long term financial incentive (36 weeks) on individual behavior in achieving a goal. in this study, the investigators also examine two additional financial incentive structures: gain streak and loss streak. if the hypotheses are correct, the results have important implications for designing financial incentives to encourage good behavior and to encourage good habit formation across domains.

Eligibility criteria:
inclusion criteria: * singapore citizens and permanent residents * adults with bmi greater than 22 * ownership of a smartphone or tablet * only one member per household can participate in the study exclusion criteria: * women who are pregnant or breast feeding, or who intend to become pregnant over next year * subjects who are already participating in another physical activity program or study * subjects who are unable to participate for a total of 1 year * subjects who are unwilling to wear the fitness device * subjects who already walk more than 10,000 steps a day (self-reported per-day-average over seven days) * subjects who have any of the following health conditions: * high blood pressure * high cholesterol * heart attack * heart failure * stroke * chronic obstructive pulmonary disease * kidney disease * diabetes (type 2)
comparison of three different doses of intrathecal morphine for analgesia after cesarean section

Conditions: Cesarean Section; Spinal Anesthesia; Postoperative Analgesia

Summary: in our study, it was aimed to determine the dose of morphine that provides the most effective analgesia with the least incidence of side effects in the postoperative period.

spinal anesthesia is a widely used method in cesarean section operations. it has become a popular practice to add opioids to local anesthetic agents to improve the quality and prolong the duration of intraoperative and postoperative analgesia. morphine and fentanyl are commonly used opioids for this purpose. in cesarean sections, intrathecal morphine (itm) is preferred for postoperative analgesia due to its slow onset and long-term analgesia, and intrathecal fentanyl is preferred for intraoperative analgesia due to its faster onset of action. itm can cause side effects such as nausea, vomiting, itching, sedation and respiratory depression. the quality of analgesia and the incidence of side effects may vary depending on the itm dose used. there are studies indicating that reducing the dose of itm results in good quality, long-term analgesia with a low incidence of side effects. however, the ideal dose of itm providing optimal postoperative analgesia with the lowest incidence of side effects for cesarean section has not been determined yet in the literature. for this purpose, in this study it was compared the postoperative analgesia efficiency and incidence of side effects of three different itm doses in order to contribute to the literature. patients were divided into three groups: group 1: 10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 80 mcg intrathecal morphine was administered. group 2: 10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 120 mcg intrathecal morphine was administered. group 3: 10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 160 mcg intrathecal morphine was administered. all patients received iv patient controlled analgesia (pca) prepared with fentanyl postoperatively.

Eligibility criteria:
inclusion criteria: * patient undergoing cesarean section * between the ages of 18-40, * asa ii, * pregnant women with gestational week \> 36 exclusion criteria: * not accepting regional anesthesia, * i̇nfection at the injection site, * coagulopathy, bleeding diathesis, * severe hypovolemia, * i̇ncrease in intracranial pressure, * pregnant women with problems such as severe aortic stenosis, severe mitral stenosis for which spinal anesthesia is contraindicated, * patients with a history of allergy to any drug included in the study protocol

Keywords: postoperative pain intrathecal morphine