Kornimate/medical-research-clean huggingface dataset:
effectiveness of internet cognitive behavioral therapy intervention for treating insomnia

Conditions: Sleep Initiation and Maintenance Disorders

Summary: this study will evaluate the effectiveness of an online cognitive behavioral therapy intervention in improving sleep, mood, and cognitive functioning in people with insomnia.

insomnia is a disorder that is characterized by a perception or complaint of inadequate or poor-quality sleep. symptoms of insomnia include difficulty falling asleep, waking frequently during the night and having difficulty returning to sleep, waking too early in the morning, and unrefreshing sleep. insomnia may also cause problems during the day, such as tiredness, difficulty concentrating, and irritability. cognitive behavior therapy (cbt) has been found to have significant short- and long-term benefits for people with insomnia. access to cbt for many people, however, is limited, due to the high cost of treatment and a lack of trained professionals in some locations. delivering cbt via the internet could help make the treatment more widely available. this study will evaluate the effectiveness of an online cbt intervention in improving sleep, mood, and cognitive functioning in people with insomnia. participants in this open label study will be randomly assigned to receive the online cbt intervention either immediately or after a 4-month waiting period. participants will use the online program for 1 to 2 hours per week for 8 weeks. participants will keep track of their sleep patterns for the first and last 2 weeks of a 4-month period by keeping a daily diary and wearing a wrist watch device that monitors movement. all participants will report to the study site for baseline evaluations before beginning treatment and for final evaluations upon completing the program, about 4 months after study entry.

Eligibility criteria:
inclusion criteria: * subjective complaints of poor sleep * difficulties falling and/or staying asleep (sleep onset latency and/or wake after sleep onset is greater than 30 minutes; sleep efficiency is less than 85%) * sleep difficulties at least 3 nights per week * sleep difficulties have persisted for more than 6 months * at least one daytime problem due to poor sleep (e.g., fatigue, performance impairment, or mood disturbance) * daytime problems due to sleep disturbances cause marked distress or significant impairment in social or occupational functioning * has internet access exclusion criteria: * presence of other sleep disorders (as evaluated by specific questions from structured interview) (e.g., sleep apnea, periodic leg movements while sleeping, or parasomnias) * significant psychological distress (including clinical depression and anxiety), as determined using the beck depression inventory (bdi), stpi, patient health questionnaire (phq), and clinical interview * substance use or medical condition that causes sleep problems * currently receiving psychological treatment * taking medications that have not been stabilized for the 3 months prior to study entry * regularly goes to sleep after 2am or wakes after 9am * shift worker

Keywords: internet cbt insomnia sleep
antalgic effects of well-being treatments in cancer care

Conditions: Cancer; Cancer Pain

Summary: observational , monocentric, study to assess antalgic effects of well-being treatment in cancer care.

contrary to supportive care, well-being care is imperfectly assessed. well being care (wbc) consist on complementary programs, with no real consensus. very few studies have rigorously evaluated its benefits the objective of this study was to evaluate the impact of four well-being treatments (foot reflexology, socio-aesthetics, sophrology and singing) provided in a healthcare facility

Eligibility criteria:
inclusion criteria: * all type of cancer treated at the general hospital of valence * patient agree to participate on well being session: foot reflexology, socio-aesthetics, sophrology and singing * age ≥ 18 years * affiliation to a social security system * patient who has given written consent signed before any specific procedure of the protocol exclusion criteria: * patient under guardianship, deprived of liberty, safeguard of justice * patient presenting a serious psychiatric pathology that does not allow compliance with the completion of the scale (at the discretion of the investigator) * refusal to participate in research
staphylococcus aureus bacteraemia in adults

Conditions: Staphylococcus Aureus Bacteremia

Summary: the purpose of this evaluation is to record the management and outcome of adults with s.aureus bacteraemia (sab) across multiple european, asian and north american sites and to identify key quality indicators associated with improved outcome.

staphylococcus aureus (s. aureus) is one of the most common causes of bloodstream infections. associated mortality has been reported to vary widely (4%-40%) although no obvious explanation for such variation has been identified. despite the existence of clinical guidelines, there is considerable variation in the management of s.aureus bacteraemia (sab) between centres. part of the variation in clinical management is due to the limited evidence base defining optimal therapy. fewer than 1500 patients have been recruited to randomised controlled trials in the past 40 years; practice is therefore based largely on experience and observational studies. the purpose of this evaluation is to record the management and outcome of adults with sab across multiple european, asian and north american sites. we aim to establish a broader knowledge base, identify key quality indicators associated with improved outcomes, and to provide comparator data to ensure that patients enrolled in randomized controlled trials are representative of bacteraemic s. aureus patients as a whole. all participating centres are experienced in the management of s. aureus bacteraemia and in conducting evaluations of current management practice and outcomes from s. aureus bacteraemia. data is checked for plausibility by a centralized data quality control group.

Eligibility criteria:
inclusion criteria: * s. aureus (methicillin sensitive or resistant) isolated from one or more blood cultures exclusion criteria: * recurrent episodes of s. aureus bloodstream infection * polymicrobial infection

Keywords: staphylococcus aureus bloodstream infection bacteremia
anatomical variations of femoral nerve location in relation to femoral artery

Conditions: Femoral Fractures

Summary: the goal of this observational study is to learn about the relative position of femoral nerve in relation to the femoral artery in patients scheduled for femoral fractures using ultrasound scanning. the classical description of femoral nerve is that it lies immediately near to artery, but it is not always true. the nerve lies at a varying distance from the artery. the main question it aims to answer are: • is the age sex and body mass index affect the relationship between femoral artery and nerve?

the femoral nerve block is ideal for surgeries of the femur, knee, or anterior thigh and is often combined with a sciatic nerve block for near complete lower extremity analgesia. the classic teaching is that the femoral nerve lies lateral to femoral artery sandwiched between the fascia iliaca and iliopsoas muscle1. aim: the objective of the study is to find out the anatomical variation in the site of the femoral nerve in relation to the femoral artery, with respect to the age, sex, weight and ethnicity of the patient.

Eligibility criteria:
inclusion criteria: * above the age of 18 coming for fixation of femoral fracture exclusion criteria: * below the age of 18 * patient not willing to participate * patients with neurological illness that hinders from giving a valid consent * patients with local pathology at inguinal region

Keywords: femoral fracture ultrasound anatomy of femoral nerve
endometrial priming for embryo transfer

Conditions: Sterility

Summary: the aim of this trial is compare two different endometrial priming protocols * women that receive oral estrogens * women that receive transdermal estrogens


Eligibility criteria:
inclusion criteria: * women between 18-50 years old with desire of children and needs of embryo transfer. * plasma prolactin less than 30. * uterine cavity that allow pregnancy, body mass index between 20-30. * and signed consent inform. exclusion criteria: * history of estrogen dependent cancer, unknown origin vaginal bleeding. * ovarian cyst. * contraindications to be pregnant. * estrogen allergy.

Keywords: oral estrogens transdermal estrogens endometrial priming
butyphthalide in combination with recombinant tissue plasminogen activator for acute ischemic stroke

Conditions: Stroke, Ischemic

Summary: acute ischemic stroke (ais) is the most common type of stroke, which has high rate of morbidity, mortality and disability. a large number of studies have confirmed that the thrombolytic therapy can effectively open blood vessels and improve the functional prognosis of acute ischemic stroke. therefore, all guidelines recommend giving thrombolysis treatment to acute ischemic stroke patients within 4.5 hours of onset. however, about 1/3 patients receiving thrombolysis will have good prognosis, while a large number of patients will still be disabled and even dead. how to improve the neurofunctional prognosis of thrombolytic patients has been a hot topic in the world. butyl phthalide is type i chemical drugs. some multicenter randomized, double-blind, placebo-controlled clinical trials have showed that acute ischemic stroke patients taking butyl phthalide has better lateral branch circulation and living ability score than patients taking placebo. besides, butyl phthalide treatment is safe. the animal experiment indicated that buphthalein could significantly improve secondary side branch circulation, recover the microarterial diameter of the soft meninges in the ischemic region and increase the blood flow rate. based on the discussion, we assume that: giving butyl phthalide to patients with acute ischemic stroke in advance, might promote and improve the formation of collateral circulation to freeze ischemia penumbra. based on this hypothesis, we would like to explore the efficacy and safety of butyl phthalide combined with rtpa thrombolysis in the treatment of acute ischemic stroke.


Eligibility criteria:
inclusion criteria: 1. age \>18 years; 2. diagnosis of anterior circulation infarct; 3. first stroke onset or past stroke without obvious neurological deficit (mrs≤1); 4. time from onset to treatment ≤4.5 hours; 5. sbp/dbp ≤ 180/110mmhg; 6. no hemorrhagic imaging changes showed in ct; 7. signed informed consent by patient self or legally authorized representatives. exclusion criteria: 1. history of stroke within 3 months; 2. history of intracranial hemorrhage; 3. suspected subarachnoid hemorrhage; 4. intracranial tumour, vascular malformation or arterial aneurysm; 5. major surgery within 1 month; 6. systolic pressure ≥180 mmhg or diastolic pressure ≥110 mmhg; 7. platelet count \< 100×109／l; 8. heparin therapy or oral anticoagulation therapy within 48 hours; 9. severe disease with a life expectancy of less than 3 months; 10. blood glucose \< 50 mg/dl (2.7mmol/l); 11. patients who have received any other investigational drug or device within 3 months; 12. researchers consider patients inappropriate to participate in the registry. -

Keywords: thrombolysis butyphthalide
three channel food concept: the effect meal service on food intake during hospitalization

Conditions: Nutrition Poor; Protein-Energy Malnutrition

Summary: the goal of this observational study is to assess food intake in hospitalized patients. the present study will evaluate the impact of a novel in-hospital meal concept (three channel food concept) on total energy and protein intake, macronutrient distribution, and patient appreciation food intake will be assessed (as part of usual care) by weighing all leftovers (e.g. food that patients did not consume).

there are various possible strategies to increase protein intake during hospitalization, such as providing more protein-rich foods, fortifying meals and/or food products, supplementation with oral nutritional supplements (ons), and/or providing well-timed snacks. an appropriate in-hospital meal service is regarded as a key element of the strategy to minimize deterioration of the nutritional status. conventional hospital meals, 3 main meals a day prepared by a central kitchen, are often low in protein and energy and are not appreciated by patients due to lack of taste, colour and flavour, resulting in inadequate food intake particularly protein intake. there are a number of avenues to improve nutritional intake, with type of meal service and existence of individual contact with catering staff, like mealtime assistance, as important factors. the mumc+ has adapted it's in-hospital meal system and the present study will evaluate the impact of this novel in-hospital meal concept (three channel food concept) on total energy and protein intake, macronutrient distribution, and patient appreciation. the aim of this study is to assess whether a novel in-hospital meal concept can effectively increase daily total protein and energy intake during hospitalization, when compared to a historic control.

Eligibility criteria:
inclusion criteria: * \>18y * admitted to surgical nursing wards of mumc+ * expected hospital stay of at least 3 days exclusion criteria: * receiving (par)enteral nutrition * "npo" (nil per os) policy
injection site tolerability, safety, pharmacokinetics, pharmacodynamics in different single-dose treatments of alirocumab sar236553 (regn727) in healthy subjects

Conditions: Hypercholesterolemia

Summary: primary objective: injection site tolerability secondary objectives: * to assess the safety profile of alirocumab sar236553 (regn727) * to assess the pharmacokinetic-pharmacodynamic relationship of alirocumab sar236553 (regn727)

total duration for each subject (not including screening) will be approximately 85 days.

Eligibility criteria:
inclusion criteria: * serum ldl-c levels \>100 mg/dl. exclusion criteria: * subjects indicated for the use of statins according to criteria in adult treatment program (atp) iii guidelines, as updated in 2004. * initiation of a new diet or major change to a previous diet within 4 weeks prior to screening. subjects must be willing to maintain a consistent diet for the duration of the study. * use of a medication or nutraceutical in order to alter serum lipids within 4 weeks prior to screening, including but not limited to statins, cholesterol absorption inhibitors, fibrates, niacin, bile acid resins, or red yeast rice. * fasting serum triglycerides \>200 mg/dl measured after an 8-12 hour fast. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
efficacy of clonidine and propranolol in dentistry (aaa)

Conditions: Anxiety

Summary: the aim of the study is to determine the efficacy of clonidine and propranolol for transient anxiety management and intra and postoperative pain in patients undergoing ambulatory surgery of third molar.

there will be a randomized, triple-blind, placebo-controlled clinical trial with parallel group design to determine the efficacy of the pre medication propranolol and clonidine versus placebo for reducing anxiety during third molar removal surgery. patients will be assigned to 3 groups of 20 patients each. one group will receive 150 mcg of clonidine, the second group will receive propranolol 40mg, and the control group will receive placebo. the modified dental anxiety scale will be applied before and after surgery in order to evaluate the change in anxiety level, which will be assessed as the primary outcome. the secondary outcomes include the measurement of changes in blood pressure, heart rate and respiratory rate evaluated before, during and after surgery. additionally, pain will be assessed through numerical pain scale at 3, 6 and 24 hours after surgery. also, possible side effects will be identified (vomiting, nausea, dry mouth, dizziness and drowsiness). statistical analysis: qualitative variables will be described by absolute and relative frequencies, and quantitative variables will be described by the mean along with standard deviation or the median with interquartile range depending on the distribution of the data. one-way anova or kruskal wallis will be used (depending on the fulfillment of assumptions) in order to compare the quantitative variables amongst the groups. the chi squared test will be used to compare the qualitative variables. the confidence intervals will be estimated at 95% for all effect magnitude measurements calculated.

Eligibility criteria:
inclusion criteria: * normotensive patients and pre-hypertension who are undergoing elective surgery for removal of third molars. * age range 14 to 40 years * patients with dental anxiety above 13 points on the scale (mdas). * people who voluntarily agree to participate in the study and sign the informed consent form exclusion criteria: * patients receiving any medication for any chronic pathology. * patients of african american race, being more likely to have abnormal blood pressure. * patients with a history of cardiovascular disease. * patients with chronic systemic disease such as diabetes, hyper or hypothyroidism, addison's syndrome, renal failure, hypertension or liver disease. * pregnant or breastfeeding. * patients diagnosed with anxiety disorder or depressive disorder

Keywords: clonidine propranolol third molar anxiety
levetiracetam in the management of bipolar depression

Conditions: Bipolar Depression

Summary: a 6-week outpatient, double-blind, placebo-controlled, add-on trial to investigate the effects of levetiracetam on depressive symptoms in bipolar depressed patients.


Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of bipolar disorder * presence of a current major depressive episode on the scid * score of 17 or great on the hdrs * capable of giving voluntary written consent exclusion criteria: * significant current substance dependence/abuse within 3 months preceding the trial * active suicidal ideation * pregnant/lactating mothers * significant medical history

Keywords: keppra levetiracetam anticonvulsant depression bipolar disorder affective disorders mood disorders double blind acute antidepressant effects
neonatal cerebral oxygenation after exposure to oxygen evaluated with the invos oximeter

Conditions: Response to Hyperoxia

Summary: * due to the increased risk of brain damage, continuous monitoring of the cerebral oxygenation is interesting. the investigators will evaluate the capability of the invos oximeter to detect induced changes in the cerebral regional saturation. * the purpose of the study is to investigate our hypothesis that cerebral vasoconstriction after oxygen exposure is prolonged in preterm infants compared to term infants.

preterm infants are at increased risk of brain damage compared with term infants, and cerebral hypoxia is considered to have an important role. the preterm infants are at increased risk of respiratory distress, episodes with low oxygenation, mechanical ventilation, risk of hypocapnia and labile or low blood pressure. these conditions can affect the microcirculation and hence the oxygenation of the brain. hyperoxia is also a point of interest, since high levels of oxygen can cause vasoconstriction. the investigators will examine the normal physiological cerebral response to exposure of oxygen in a group of preterm infants with a gestational age (ga) of 32-37 weeks and a group of term infants. the investigators will do dynamic research with continuously monitoring of the cerebral oxygenation using the invos® cerebral/somatic oximeter (near infrared spectroscopy (nirs)). reproducibility is examined by repeated measurements. there will be no follow-up.

Eligibility criteria:
inclusion criteria: * newborns with a gestational age of 32-40 weeks * clinically stable * +/- cpap with a oxygen limit below 30% * parental consent exclusion criteria: * severe birth asphyxia * prohibition of oxygen exposure

Keywords: preterm newborn neonate cerebral oxygenation oxygen
derivation of human induced pluripotent stem (ips) cells to heritable cardiac arrhythmias

Conditions: Inherited Cardiac Arrythmias; Long QT Syndrome (LQTS); Brugada Syndrome (BrS); Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT); Early Repolarization Syndrome (ERS); Arrhythmogenic Cardiomyopathy (AC, ARVD/C); Hypertrophic Cardiomyopathy (HCM); Dilated Cardiomyopathy (DCM); Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy); Normal Control Subjects

Summary: human induced pluripotent stem cells (hipscs) have driven a paradigm shift in the modeling of human disease; the ability to reprogram patient-specific cells holds the promise of an enhanced understanding of disease mechanisms and phenotypic variability, with applications in personalized predictive pharmacology/toxicology, cell therapy and regenerative medicine. this research will collect blood or skin biopsies from patients and healthy controls for the purpose of generating cell and tissue models of mendelian heritable forms of heart disease focusing on cardiomyopathies, channelopathies and neuromuscular diseases. cardiomyocytes derived from hipscs will provide a ready source of disease specific cells to study pathogenesis and therapeutics.

further study details as provided by gordon f. tomaselli, johns hopkins university: biospecimen retention: blood or tissue samples, hipscs and cardiomyocytes reprogrammed from hipscs eligible patients will be approached and the study will be explained in full as a part of obtaining informed consent for the study. the subjects will have an opportunity to ask questions about the study. control subjects, often but not exclusively family member that meet the eligibility criteria will undergo a similar procedure for informed consent. subjects will be evaluated in clinic and will have a 1-3 mm skin biopsy or blood draw (30 cc). the subjects will be asked about their medical history during the clinic visit but this information will not be transmitted to the research laboratories where the ipscs are generated and re-programmed, only the disease genotype will be associated with the samples. the samples that will be frozen and stored are whole blood, white blood cells, skin biopsies, hipscs and reprogrammed cardiomyocytes.

Eligibility criteria:
inclusion criteria: * all patients and family members 18 years of age or older with inherited cardiac arrhythmias including lqts, brugada syndrome (brs), cathecholaminergic polymorphic ventricular tachycardia (cpvt) or early repolarization syndrome (ers) are eligible for enrollment. * all enrolled patients will have undergone clinically indicated genetic testing. exclusion criteria: * age \<18 years * \>85 years * pregnant women * life-limiting co-morbidities * immunocompromise

Keywords: induced pluripotent stem cells (ipsc) channelopathies catecholaminergic arrhythmogenic