Kornimate/medical-research-clean huggingface dataset:
ramelteon for the treatment of insomnia and mood stability in patients with euthymic bipolar disorder

Conditions: Bipolar Disorder

Summary: the purpose of this study is to determine whether treating sleep difficulties in patients with bipolar disorder also improves their mood stability.

patients with euthymic bipolar disorder, although free of significant mood symptoms, often have continued sleep disturbances. improving patients' sleep by also normalizing the circadian rhythm will lead to fewer mood exacerbations. ramelteon offers a new and more pharmacologically exact mechanism to re-synchronize the scn. the administration of ramelteon for bipolar patients will improve sleep and will cause fewer mood exacerbations. patients with bipolar disorder often experience frequent mood alterations that are attempted to be controlled by mood stabilizing agents and anti-psychotic agents. both classes of medications have numerous significant side effects. establishing that ramelteon is helpful in the sleep of patients with bipolar disorder and helpful in mood stability will increase the number of treatment options for bipolar patients.

Eligibility criteria:
inclusion criteria: 1. provision of written informed consent before initiation of any study-related procedures 2. men and women aged 18 to 65 years. 3. a documented clinical diagnosis according to the dsm-iv (diagnostic and statistical manual of mental disorders, 4th edition, text revision) meeting criteria 296.4x bipolar i disorder, most recent episode manic, 296.6x bipolar i disorder, most recent episode mixed, or 296.5x bipolar i disorder, most recent episode depressed. 4. psqi total score of \>=5. 5. madrs total score of \<=12. 6. ymrs total score of \<= 12 7. female patients of childbearing potential must have a negative urine pregnancy test at enrollment and be willing to use a reliable method of birth control, i.e., double-barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device or tubal ligation, during the study. 8. be able to understand and comply with the requirements of the study, as judged by the investigator. 9. outpatient status at enrollment. exclusion criteria: 1. patients with a diagnosis of dsm-iv axis ii disorder which has a major impact on the patient's current psychiatric status. 2. presence of prohibited medications of antidepressants (including maoi's) and systemic corticosteroids. 3. patients with a diagnosis of primary insomnia disorders 4. patients with a diagnosis of severe chronic obstructive pulmonary disease 5. a clinical finding that is untreated (eg, hypertension, poorly controlled diabetes, angina) or that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect the study medication. 6. patients with active substance abuse diagnoses (except tobacco abuse). 7. known history of intolerance or hypersensitivity to ramelteon or to any other component in the tablet.
feasibility of fasting & exercise in pts with hr+ mbc

Conditions: Breast Cancer; Metastatic Breast Cancer

Summary: this research is evaluating the impact of a 12-week prolonged nightly fasting (pof) and exercise intervention on metabolic markers and patient reported outcomes in women with metastatic breast cancer (mbc) initiating endocrine therapy in combination with palbociclib or alpelisib.

this is single-arm feasibility pilot study exploring whether a combined prolonged nightly fasting (pof) and exercise program could impact hyperglycemia and other adverse metabolic consequences of pi3 kinase inhibitors in women with metastatic breast cancer (mbc). women who exercise regularly and who have lower levels of blood sugar and metabolic hormones like insulin have a lower risk of developing breast cancer. some evidence also suggests that exercise and metabolism are related to cancer recurrence in women who are diagnosed with breast cancers that can be removed with surgery, but less is known about how exercise and metabolic factors are related to cancer progression in women whose cancer has advanced beyond the breast and underarm lymph nodes. this study is designed to look at the effects of exercise combined with prolonged nightly fasting (having a longer time between dinner and breakfast the next day), on blood sugar and hormones that control metabolism. this study looks to provide important information about whether making these kinds of changes is possible for women living with advanced breast cancer and will explore how making these changes effects blood sugar and hormone levels in women taking different kinds of treatments for advanced breast cancer. the research study procedures include screening for eligibility, a baseline visit to collect information about diet and exercise habits, a baseline blood draw, participation in a 12-week diet and exercise program, and a follow up visit and blood collection at the end of the diet and exercise program. participants will be in this research study for up to 14-weeks, including the baseline and end of study visits to collect study measures. it is expected that about 30 people will take part in this research study

Eligibility criteria:
inclusion criteria: * diagnosis of er and/or pr+ metastatic or locally unresectable breast cancer * postmenopausal (including concurrent use of ovarian suppression) * initiating endocrine therapy in combination with: * cohort 1: alpelisib * cohort 2: palbociclib * self-reported ability to walk two blocks * \> 18 years of age * approval from treating oncologist, confirmed via email or in writing * ability to read and understand english exclusion criteria: * diagnosis of diabetes requiring medication * engaging in \>90 minutes of moderate or vigorous physical activity per week

Keywords: breast cancer metastatic breast cancer
pumping to up maternal milk production for preterms

Conditions: Breastfeeding; Breastmilk Expression

Summary: the goal of this clinical trial is to learn about the effect of breast-pumping frequency on breast milk supply/ volume in mothers of preterm infants. the main question it aims to answer is: - what effect does pumping frequency have on breast milk supply. researchers will compare breastmilk supply of mothers who pump every 2 hours to the supply of those who pump every 3 hours to see if there is a difference in the amount of breastmilk they produce. participants will be assigned to either pump every 2 hours or every 3 hours and record how many milliliters of breastmilk they produce daily for the first 28 days of their baby's life.


Eligibility criteria:
inclusion criteria: * inborn infants \<32 weeks gestation * out-born infants transferred to our facility \<48hours of life * infants \<1500 grams at birth * infants whose parents/ guardians have provided legal consent for study participation exclusion criteria: * infants with birthing persons' that are severe/critically ill * birthing persons of infants \<18 years old * infants with terminal illness or decision to withhold or limit support * infants with major congenital anomalies, chromosomal disorders, or congenital infections

Keywords: breastmilk supply in preterm infant breastfeeding preterm infants
treating perfectionism using internet-based cognitive behavior therapy

Conditions: Perfectionism; Anxiety; Depression; Stress

Summary: perfectionism is characterized by setting high standards and striving for achievement, sometimes at the expense of social relationships and wellbeing. despite sometimes being viewed as a positive feature by others, people with perfectionism tend to be overly concerned about their performance and how they are being perceived by people around them. this tends to create inflexible standards, cognitive biases, and performance-related behaviors that maintain a belief that self-worth is linked to accomplishments. cognitive behavior therapy has been shown to be a viable treatment for perfectionism, both in terms of reducing levels of perfectionism and improving psychiatric symptoms. furthermore, a number of recent studies indicate that it can be successfully delivered via the internet, both with regular support and guidance on demand from a therapist. in the present study protocol, a clinical trial for perfectionism is described and outlined. in total, 128 participants will be recruited and randomized to either a treatment that has already been demonstrated to have many benefits, internet-based cognitive behavior therapy for perfectionism (icbt-p), or an active comparison condition, internet-based unified protocol (iup), targeting the emotions underlying depression and anxiety disorders. the results will be investigated with regard to self-reported outcomes of perfectionism, psychiatric symptoms, self-compassion, and quality of life, at post-treatment and at six- and 12-month follow-up. both icbt-p and iup are expected to have positive effects, but the difference between conditions and adherence to respective treatment are currently unknown and will be explored. the clinical trial is believed to lead to a better understanding of how perfectionism can be treated, with the aim of providing efficacious treatments in an accessible format via the internet.


Eligibility criteria:
inclusion criteria: * at least 18 years * adequate reading and writing levels in swedish * a computer, smartphone, or tablet with internet access * elevated levels of perfectionism, as determined by a score of \>29 on the subscale concerns over mistakes on the frost multidimensional perfectionism scale exclusion criteria: * diagnoses warranting immediate care, e.g., anorexia nervosa, substance abuse, bipolar disorder, psychosis, and schizophrenia * severe depression, as determined by a score of \>15 points on the patient health questionnaire - 9 items * suicidality, as determined by \>2 points on the item on suicidal ideation on the patient health questionnaire - 9 items

Keywords: perfectionism cognitive behavior therapy unified protocol internet-based randomized controlled trial
understanding barriers and facilitators to the participation of women living with hiv in clinical trials : a mixed-method study (eva)

Conditions: HIV

Summary: to identify the most important barriers and facilitators to the participation of cisgender women living with hiv in clinical trials (perceived and real) and to establish possible mechanisms leading to refusal of trial participation. specifically, psychosocial factors and/or cultural environments that enhance or undermine hiv-positive cisgender women's participation. these can include social inclusion, confidence in research, perceived personal vulnerability, cultural, familial and professional environment. the investigators expect to propose pragmatic solutions to enhance participation of hiv-positive cisgender women in clinical trials.


Eligibility criteria:
inclusion criteria: * cisgender women * adult (\>18 years) hiv-infected * informed consent documented by signature * patients under stable antiretroviral therapy * french speaking (sufficient fluency for a conversation) exclusion criteria: * having participated in a previous qualitative study about cure trials acceptability among hiv patients * incapable of discernment

Keywords: hiv clinical trials women qualitative study
a study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab given every 4 weeks in participants with hemophilia a

Conditions: Hemophilia A

Summary: this multicenter, open-label, non-randomized study will assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab administered at a dose of 6 milligrams per kilogram (mg/kg) every 4 weeks in participants with hemophilia a with or without inhibitors against factor viii (fviii). the study consists of 2 parts: a pharmacokinetic (pk) run-in part followed by an expansion part.


Eligibility criteria:
inclusion criteria: * body weight greater than or equal to (\>/=) 40 kilograms (kg) at screening * diagnosis of severe congenital hemophilia a or hemophilia a with fviii inhibitors * participants using rfviia or willing to switch to recombinant activated factor vii (rfviia) as primary bypassing agent for the treatment of breakthrough bleeds * fviii inhibitor test during screening with titer results available prior to first administration of study drug * participants without fviii inhibitors, that is with less than (\ ) 0.6 bu/ml (\> 1.0 bu/ml only for laboratories with an historical sensitivity cutoff for inhibitor detection of 1.0 bu/ml) since iti * adequate hematologic, hepatic, and renal function exclusion criteria: * inherited or acquired bleeding disorder other than hemophilia a * ongoing or planned iti therapy; participants in whom iti has failed will be eligible with a 72-hour washout period prior to the first emicizumab administration * history of illicit drug or alcohol abuse within 48 weeks prior to screening, in the investigator's judgment * participants who are at high risk for thrombotic microangiopathy (tma) (for example, have a previous medical or family history of tma), in the investigator's judgment * previous (within the last 12 months) or current treatment for thromboembolic disease (with the exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or signs of thromboembolic disease * other conditions (for example, certain autoimmune diseases) that may currently increase the risk of bleeding or thrombosis * history of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection * known hiv infection with cluster of differentiation (cd) 4 cells counts \<200 cells per microliter (cells/mcl) * use of systemic immunomodulators (for example, interferon) at enrollment or planned use during the study, with the exception of anti-retroviral therapy * concomitant disease, condition, significant abnormality on screening evaluations or laboratory tests, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an additional unacceptable risk in administering study drug to the participant * pregnancy or lactation or intention to become pregnant during the study * women with a positive serum pregnancy test result within 7 days prior to initiation of study drug
cilostazol verse asprin for vascular dementia in poststroke patients with white matter lesions

Conditions: Vascular Dementia; Stroke

Summary: the purpose of this study is to evaluate the efficacy of pde-3 inhibitor, cilostazol, in prevention and treatment of vascular dementia, in those with brain white matter lesions and vascular risk factors.


Eligibility criteria:
inclusion criteria: 1. age ranging from 40 to 80 years 2. after newly ischemic stroke from 3 months to 2 years 3. brain ct or mri shows stroke lesions and white matter lesions, arwmc(age related white matter change)\>=4 4. moderate or mild cognitive deficits: mmse 12-26 5. vascular or mixed dementia: hachinski ischemic score\>4 6. moderate or mild disability: mrs\<=4,nihss\<20 7. informed consent exclusion criteria: 1. definitive diagnosis of dementia prior to the stroke 2. cerebral hemorrhage in the past 3. cerebral embolism result from cardiogenic embolus 4. critically ills: mrs\>4,nihss\>=20 5. bed-ridden patient who is hardly discovered newly stroke 6. patient with sever cardiac, hepatic or nephric complication 7. dementia caused not by vascular lesions 8. other diseases disturb the cognitive evaluation 9. susceptibility to varieties of allergen 10. abstain from cilostazol or asprin 11. antiplatelet treatment, anticoagulation or fibrinolysis are needed because of other diseases 12. rejected to participate by the patient or the family

Keywords: cognition
treatment of periodontitis by conventional 4 weekly sections or within 24 hours

Conditions: Periodontitis

Summary: periodontitis is a form of gum disease that affects many people in the world. its traditional protocol of treatment includes oral hygiene instruction and dental scaling to remove debris, dental plaque and tartar in 4 weekly sections. there is an additional time-reduced option also usually cheaper. in this last one, all above described procedures are performed within 24 hours. however, up to now comparative effectiveness between these both types of treatment is not well understood. for, example it is not clear if patients treated in the shorter-time experienced more pain. therefore, the present study used several parameters to clarify whether beneficial differences between these therapeutic protocols exist or not. in addition, aspects that could help clinicians' and patient's decisions such as experience of pain and anxiety related to dental treatment were also investigated. after receiving verbal and written explanations and signed the informed consent form 150 individuals (n=15/group) having the most common type of periodontitis in adults were randomly allocated to be treated in 4 weekly sections or within 24 hours. oral hygiene instructions and dental debridement were performed alone or in conjunction with antimicrobial agents: a mouth rinse containing chlorhexidine or systemic azithromycin antibiotic tablets. the parameters measured at baseline, 3, 6 and 9 months after treatment were: indicators of inflammation, amount of oral debris and malodor; quantification of bacteria in plaque samples collected with paper points from teeth and tongue; amount of produced saliva and self-reported questionnaires to collect information about oral condition, daily activities, pain and anxiety related to dental treatment.


Eligibility criteria:
inclusion criteria: * mild to moderate chronic periodontitis; * at least 20 natural teeth; * good general health exclusion criteria: * systemic diseases or other conditions that could influence the periodontal status; * events of high blood pressure or diagnosed hypertension; * alcohol abuse; * orthodontic devices; * extended prosthetic fixed devices, removable partial dentures or overhanging restorations; * pregnancy or breast-feeding; * history of sensitivity or suspected allergies following the use of oral hygiene products and/or the test antibiotic; * the need for antibiotic prophylaxis; * antibiotics and/or anti-inflammatory drug use in the three months prior to the beginning of the study; * regular use of chemotherapeutic antiplaque/antigingivitis products; * any furcation lesions; * periodontal treatment performed within six months prior to study initiation; * unwillingness to return for follow-up.
execution of trans-esophagus echo cardiogram in cardiopulmonary resuscitation for patients with out-of-hospital cardiac arrest

Conditions: Out-Of-Hospital Cardiac Arrest

Summary: the purpose of this single center, randomized clinical control trial is to determine that changing chest compression site during cardiopulmonary resuscitation according to the examination of the tee could increase the level of end-tidal co2, which represents the quality of cardiopulmonary resuscitation, or not in adult patients with non-traumatic out-of-hospital cardiac arrest while comparing to those who don't receive examination of transesophageal echocardiography during cardiopulmonary resuscitation.


Eligibility criteria:
inclusion criteria: 1. age ≥ 20 years-old 2. out-of-hospital cardiac arrest 3. non-trauma exclusion criteria: 1. obvious signs of death appears, such as separation of head and body, rigor mortis, livor mortis, cankered corpse......etc. 2. family members clearly express the willing of do not attempt resuscitation or patients who have registered advance care planning not to attempt resuscitation. 3. patients not suitable for transesophageal ultrasound, such as patients with esophageal tumor, those whose probe cannot be placed......etc. 4. received extracorporeal cpr. 5. achieving sustained rosc before ed arrival

Keywords: out-of-hospital cardiac arrest chest compression site transesophageal echocardiography end-tidal co2
an observational study to evaluate the safety and efficacy of pegfilgrastim (neulasta®)

Conditions: Breast Cancer Female; Breast Neoplasm Female

Summary: the purpose of this observational study is to evaluate real-world safety and efficacy of pegfilgrastim (neulasta) administered as secondary prophylaxis in korean female patients with breast cancer receiving chemotherapy regimens recently covered under national health insurance. this is a prospective, observational, open-label trial with a target enrollment of 1400 subjects. primary endpoint the primary aim of this study is to determine the incidence of febrile neutropenia. secondary endpoint major secondary endpoint include a) incidence of bone pain, b) all adverse events, c) percentage of patients with rdi (relative dose intensity) ≥ 85%


Eligibility criteria:
inclusion criteria: * ≥ 19 years old, and ≤ 64 years old, and * female patients with breast cancer receiving chemotherapy recently covered under national health insurance (only chemotherapy regimens in the table below), and * patients with neutropenic events (febrile neutropenia or grade 4 neutropenia) in any previous cycle that did not use g-csf for the prevention of neutropenia exclusion criteria: patients with any of the followings are excluded. * patients with a history of allergic reactions to e-coli derived proteins, human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim * uses for off-label indications such as chronic myelogenous leukemia, myelodysplastic syndrome

Keywords: febrile neutropenia neutropenia
acute effect of positive expiratory pressure versus breath stacking technique after cardiac surgery

Conditions: Complication, Postoperative; Cardiac Complication

Summary: this study evaluates the efficacy and safety of a single session of positive expiratory pressure and of breath stacking technique in patients after cardiac surgery. the same patients will receive the two interventions, with an interval of 24 hours, and the acute effect of each will be verifed.

physiotherapy uses techniques and equipment that reduce postoperative pulmonary complications. the technique called breath stacking consists of an instrumental feature composed of a unidirectional valve coupled to a face mask to promote the accumulation of successive inspiratory volumes. the technique is used to prevent atelectasis and improve gas exchange. another therapy is called expiratory positive airway pressure (epap) that uses positive end expiratory pressure (peep) in spontaneously breathing patients, keeping the airway open during expiration. the epap system consists of a face mask, a one-way valve and the expiratory resistor, which is responsible for resistance to expiratory flow, which will determine the level of peep.

Eligibility criteria:
inclusion criteria: patients with indication for coronary artery bypass grafting and valve replacement, with surgical procedure for median sternotomy. exclusion criteria: * incapacity to understand the informed consent form. * cognitive dysfunction that prevents the performance of evaluations or interventions, * intolerance to the use of epap or bs mask * with chronic obstructive pulmonary disease (copd) * cerebrovascular disease * chronic-degenerative musculoskeletal disease * chronic infectious disease * in treatment with steroids, hormones or cancer chemotherapy * hemodynamic complications (arrhythmia, myocardial infarction during the operation, with blood loss ≥ 20% of the total blood volume, defined by mannuci, et al., 2007) * mean arterial pressure \<70 mmhg and reduced cardiac output, requiring the use of intra aortic balloon or vasoactive drugs * tracheal intubation for more than 12 hours after admission to the icu or reintubated * individuals unable to maintain airway permeability.

Keywords: cardiac surgery positive end expiratory pressure physical therapy techniques pulmonary funtcion