Kornimate/medical-research-clean huggingface dataset:
mavipan: my life and the covid-19 pandemic

Conditions: Psychosocial Impacts of the COVID-19 Pandemic

Summary: the health crisis imposed by covid-19 is forcing major worldwide social reorganization that will have profound consequences on our society. currently, one-third of the world's population (\~3 billion individuals) is living under some kind of isolation or quarantine measures, causing an unprecedented and rapidly evolving psychosocial crisis. the psychosocial consequences of this health crisis will persist long after restriction measures are lifted and the pandemic is over. this impact will be significant for individuals facing unique contexts or challenges (e.g., older adults, individuals living with a disability, underprivileged families) and will most likely exacerbate existing social and gender inequalities in health and human development. there is an urgent need for information on the evolution of the psychosocial dimensions of health and coping strategies used by our population and our health and social services structures. thus, this study is designed to accelerate the availability of high-quality, real-time evidence within health and social services structures to address, support and minimize psychosocial consequences of the covid-19 pandemic. through constantly evolving research questions responsive to the course of the pandemic evolution, the rapid system transformations and adaptation of services, and knowledge users (kus) needs, mavipan aims to address, document, monitor, and evaluate the following: 1. individuals and families' adjustments and mitigation strategies, especially for those considered vulnerable and in high-risk contexts. 2. healthcare and social services workers and managers' adjustments and mitigation strategies. 3. the organization of service structures. 4. the social and economic response. to achieve these objectives, we use a mixed methods study design that combines quantitative questionnaires and qualitative interviews to deepen our understanding of elements such as the coping strategies used during the pandemic. a first measure was taken during lock-down as well as a follow-up at 3 months. another follow-up will be made at 7 months. at least one per year follow-up will be made over the course of the study (5 years). additional measures may be taken depending on the evolution of the pandemic and the sanitary measures put in place by the authorities.


Eligibility criteria:
inclusion criteria: * general population exclusion criteria: * not a resident of the province of quebec * age under 14

Keywords: psychological distress coping behaviors covid19
clinical study of utaa06 injection in the treatment of relapsed/refractory acute myeloid leukemia

Conditions: Relapsed/Refractory Acute Myeloid Leukemia

Summary: this is a single-arm, open-label, dose-escalation study to explore the safety, efficacy, and cytodynamic characteristics of the drug, and to initially observe the efficacy of the drug in subjects with relapsed/refractory b7-h3-positive acute myeloid cell line leukemia.

eligible subjects will receive 1.0×10\^8 car gdt, 2.0×10\^8 car gdt, 4.0×10\^8 car gdt, or additional doses may be added at the discretion of investigator and sponsor.

Eligibility criteria:
inclusion criteria: * (1) age≥ 18 years old, gender is not limited; * (2) expected survival time≥ 3 months; * (3) ecog score 0-1 points; * (4) acute myeloid leukemia was clearly diagnosed during screening, and tumor cells were positive for b7-h3 expression; * (5) subjects with relapsed/refractory acute myeloid leukemia who have failed standard treatment or lack effective treatment methods. * (6) coagulation function, liver and kidney function, cardiopulmonary function meet requirements. * (7) be able to understand the trial and have signed the informed consent form. exclusion criteria: * (1) malignant tumors other than acute myeloid leukemia within 5 years before screening; * (2) those who test positive for virus and syphilis; * (3) severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (new york heart association \[nyha\] classification≥ grade iii), severe arrhythmia; * (4) unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment; * (5) active infection or uncontrollable infection requiring systemic treatment within 7 days prior to screening; * (6) pregnant or lactating women, female subjects who planned to become pregnant within 2 years after cell reinfusion or male subjects whose partners planned to become pregnant within 2 years after their cell reinfusion; * (7) subjects who were receiving systemic steroid therapy within 7 days prior to the year or who were judged by the investigator to require long-term systemic steroid therapy during treatment (other than inhalation or topical use); * (8) have participated in other clinical studies within 1 month before screening; * (9) there was evidence of central nervous system invasion during subject screening, such as tumor cells detected in cerebrospinal fluid or imaging showing central infiltration; * (10) those who have graft-versus-host response and need to use immunosuppressants; * (11) those with a history of epilepsy or other central nervous system diseases; * (12) patients with primary immunodeficiency diseases; * (13) situations that other investigators consider unsuitable for enrollment.
cross-sectional and questionnaire study for leg lymphedema

Conditions: Gynecologic Cancer

Summary: the purpose of this study is to identify the incidence,feature,clinical significance for leg lymphedema after gynecologic cancer treatment.

medical records will reviewed. and all patients who met the inclusion criteria will contacted by a telephone call by a clinical research coordinator. the telephone interview questionnaire for lower extremity edema (lee) and gynecologic cancer lymphedema questionnaire (gclq) will t take approximately 20-30 min to complete. the questionnaire for lee included onset, severity, location, duration, and management. patients will also questioned concerning deep vein thrombosis to exclude other causes of lee. lee is defined as subjective edema of lower extremity based on patients' complaint. lll is defined based on a clinical diagnosis of lymphedema by a physician.

Eligibility criteria:
* inclusion criteria 1. the patient who gynecologic cancer treatment at national cancer center , korea(2001\~2011) 2. no active cancer treatment at the moment 3. available telephone communication * exclusion criteria 1. the patient unlikely to comply with the protocol \ * early ovarian cancer group inclusion criteria were early stage epithelial ovarian cancer\*, no active treatment, available telephone communication with patients, and ability and willingness to provide verbal informed consent. \*early ovarian cancer (figo stage i and ii) at national cancer center, korea who underwent cytoreductive and staging surgery between january 2001 and december 2010 * locally advanced cervical cancer group patients with locally advanced cervical cancer who treatment at national cancer center, korea between october 2001 and july 2007. of 222 patients with locally advanced cervical cancer, 74 patients were underwent pretreatment laparoscopic surgical staging and 148 patients received radiotherapy . women with locally advanced cervical cancer, no active treatment at survey, available telephone communication, and ability and willingness to provide verbal informed consent were considered to include in the current study. * primary endometrial cancer group patients with endometrial cancer who underwent surgery, no active treatment at survey, available telephone communication, and ability and willingness to provide verbal informed consent were considered to include in the current study

Keywords: lower extremity edema lower leg lymphedema lower leg edema lymphedema pelvic lymph node dissection gynecologic cancer lymphedema questionnaire
sleep actigraphy in postural tachycardia syndrome (pots)

Conditions: Postural Tachycardia Syndrome; Orthostatic Intolerance; Sleep Disorders

Summary: we propose to use actigraphy (measured by activity watches) as a tool to quantify sleep disturbances in patients with orthostatic intolerance compared with healthy control subjects. in this pilot study, we will test the null hypothesis (ho) that there are no differences in the sleep quality between patients with orthostatic intolerance and healthy control subjects.


Eligibility criteria:
inclusion criteria: * diagnosed with orthostatic intolerance by the vanderbilt autonomic dysfunction center * control subjects will be free of orthostatic intolerance and other major medical problems, free of medications during the study * age between 18-65 years * male and female subjects are eligible. * able and willing to provide informed consent exclusion criteria: * overt cause for postural tachycardia (such as acute dehydration) * self-report of pregnancy * inability to give, or withdrawal of, informed consent * other factors which in the investigator's opinion would prevent the subject from completing the protocol

Keywords: sleep orthostatic tachycardia pots
the effects of nasal airflow on upper airway dilator muscles during sleep

Conditions: Obstructive Sleep Apnea

Summary: obstructive sleep apnea (osa) is an increasingly prevalent disorder characterized by repeated upper airway collapse during sleep, resulting in oxygen desaturation and frequent arousals. the etiology of osa remains unclear. many studies indicates an association between nasal obstruction and apnea. however,the precise nature of this relationship is far from clear and the importance of resistance to nasal airflow in the pathogenesis of airway collapse in osa patients remains contentious. in this study, investigators perform 4 different ways to change subjective or objective patency of nasal cavity and observe the effects of the nasal airflow on nocturnal breathing, sleep,and upper airway muscles in osa patients.

1. all subjects underwent a standard overnight polysomnogram(psg), including continuous genioglossal electromyography measurement , electroencephalogram, electrooculogram, electrocardiogram, nasal flow (thermister), respiratory (chest and abdominal) movements,oxy-hemoglobin saturation (pulse oximeter), and body position. apnea event definitions and clinical classification were determined using the american academy of sleep medicine(aasm) guidelines 2. pharyngeal electrical current sensory threshold was performed to identify the different pharyngeal function between osa patients and normal controls

Eligibility criteria:
inclusion criteria: * osa patients (apnea/hyponea index \>5/h）with chronic nasal congestion exclusion criteria: * upper airway surgery; * current treatment with nasal topical steroids or decongestants; * internal medical diseases or psychiatric disorders that interferd with sleep.

Keywords: upper airway obstructive sleep apnea polysomnography
a research study to compare blood levels of cagrilintide and semaglutide after combined versus separate injections in people with overweight or obesity

Conditions: Obesity & Overweight

Summary: this study will compare two different ways of giving cagrilintide and semaglutide for treating overweight and obesity. the medicines will either be given together in 1 injection or as 2 separate injections. the aim of the study is to find out how the different ways of injection affect the level of the medicines in the blood. for the first 14 weeks of the study, participants will get cagrilintide and semaglutide as 2 separate injections. then participants will either switch to getting the medicines as a combined injection or continue to get the separate injections for 8 weeks. which treatment participants get after the first 14 weeks is decided by chance. participants will get the study medicines once a week for 22 weeks. a study nurse at the clinic will inject the medicines with a thin needle in participants stomach area. the study will last for about 8 months.participants will have 28 clinic visits with the study staff. for 4 of these visits, participants will stay in the clinic for 5 nights. participants will have blood drawn at 21 visits. participants will have clinical assessments and participants will be asked about their health, medical history and habits including mental health questionnaires. for women: participants must not be able to become pregnant if they wish to participate in this study.


Eligibility criteria:
inclusion criteria: * male or female of non-childbearing potential (ncbp) * aged 18-55 years (both inclusive) at the time of signing informed consent * body mass index (bmi) between 27.0 and 39.9 kg/m\^2 (both inclusive) at screening. overweight should be due to excess adipose tissue, as judged by the investigator exclusion criteria: * previous participation in trial(s) with an amylin analogue unless documented that the subject was assigned to placebo treatment. participation is defined as randomisation * any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
efficacy and safety of rivaroxaban for the prevention of stroke in subjects with non-valvular atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this is a clinical study evaluating the efficacy and safety of rivaroxaban for stroke prevention in patients with atrial fibrillation (originally described in japanese).

within the us 'johnson \& johnson pharmaceutical research \& development, l.l.c.' is sponsor.

Eligibility criteria:
inclusion criteria: * 20 years or older * japanese male or female * non- valvular atrial fibrillation documented by ecg * patients with a risk of stroke and non-cns systemic embolism exclusion criteria: * significant mitral stenosis * patients in whom anticoagulants are contraindicated

Keywords: bay59-7939 rivaroxaban non-valvular atrial fibrillation japanese patients phase iii 12620
a study to evaluate the efficacy and safety of shr0302 in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study is to evaluate the efficacy and safety of different doses of jak1 inhibitor shr0302 in subjects with moderate to severe active rheumatoid arthritis who had inadequate response to conventional synthetic dmards.


Eligibility criteria:
inclusion criteria: * provide signed informed consent. * ra diagnosis consistent with the 2010 acr/eular criteria; * moderate to severe ra defined by 6 or more tender joints, 6 or more swollen joints (68- or 66-joint count), and an esr of 28 mm/h or greater or a crp level greater than 5mg/l. * subjects were required to have an inadequate response to treatment with csdmards before baseline. * if subjects are taking permitted csdmards or low-dose corticosteroid orally at baseline , the stable doses should have lasted for more than 4 weeks already. * bmi ≥18 kg/m2 exclusion criteria: * pregnant women or refuse to receive contraception during the study. * lab abnormality within 4 weeks of randomization as follows: wbc count \<3.0×10\^9/l；neutrophil count\<1.5×10\^9/l;hemoglobin level\<90.0 g/l ; platelet count \<100×10\^9/l; ast or alt levels greater than the upper limit of normal; hbsag or hcv or hiv antibody positivity. * history of another autoimmune rheumatic disease ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases. * previous treatment with jak inhibitor or cytotoxic drugs; bdmards within 6 months of randomization; other strong immunosuppressants within 3 months of randomization.
the effects of dietary changes on gut-bacteria and fibromyalgia symptoms

Conditions: Fibromyalgia; Diet, Gluten-Free

Summary: the purpose of this study is to evaluate the efficacy of two diets - gluten-free and low-fodmap diet- in relieving symptoms of fibromyalgia, and study whether these changes could be associated with changes in the gut microbiome (gut bacteria).


Eligibility criteria:
inclusion criteria: 1. women over the age of 18, diagnosed with fm. 2. chronic widespread pain index \>= 9 and pain intensity \>= 6. 3. able to read and write in either french or english. exclusion criteria: 1. any major illness (e.g. malignancy, active inflammatory disease, metabolic disease, etc.) 2. inflammatory bowel disease. 3. severe depression (hads score for depression \> 10). 4. current use of lfd or gfd. 5. pregnancy 6. vegan diet the inclusion/exclusion criteria were set to reduce the risk of confounding factors that could affect gut microbiota composition. to date, information on microbiome alterations in individuals with fibromyalgia is only available for female patients, and thus recruitment will be limited to women.
cognitive behavioral group therapy for trichotillomania (hair pulling disorder)

Conditions: Trichotillomania

Summary: this study aims at evaluating the effectiveness of group-based cognitive behavioral therapy for trichotillomania at three clinical sites in norway.

the norwegian trichotillomania project is a multicenter study that aims at evaluating the effectiveness of behavioral group therapy for ttm, i.e., act (acceptance and commitment therapy) enhanced habit reversal training (act-enhanced hrt). participants are adults or adolescents (16 year or older) who fulfill criteria for ttm according to dsm-iv. inclusion started in january 2013 and will be completed by mai 2016. treatment is delivered at three treatment sites in norway; in kristiansand, oslo, and trondheim. treatment is manualized, following the manual of twohig and woods, and consists of ten group sessions of three hours delivered at consecutive weeks, and two or three booster sessions during the first year after treatment. treatment outcome is evaluated by three outcome measures; the massachusetts general hospital - hairpulling scale (self-report); the national institute of mental health trichotillomania severity scale (clinical interview, conducted by independent evaluators); and the clinical global impression scale for ttm. outcome is measured at three points in time; at baseline, at the end of treatment, and at one-year follow-up. mixed models procedures in spss is used to analyze longitudinal data. the first paper will be written on patients admitted to treatment from january 2013 to september 2014, and includes 53 patients (49 women and four men). by january 2016, fifty-one patients (96%) had participated in the one-year follow-up evaluation.

Eligibility criteria:
* inclusion criteria: * clinical diagnosis of trichotillomania * age between 16 and 67 * exclusion criteria: * schizophrenia spectrum disorder * substance addiction * severe antisocial, schizotypal, or paranoid personality disorder * severe eating disorder, * ongoing suicidal ideation * pervasive developmental disorder * mental retardation and severe sequelae after brain injury.

Keywords: effectiveness trichotillomania hair pulling habit reversal training acceptance and commitment therapy cognitive behavioral therapy
associations of socioeconomic adversity and sleep with allostatic load among toddlers

Conditions: Sleep Disorder

Summary: a longitudinal study to examine the relationships among sleep characteristics, stress, and child behavior problems in a community sample of toddlers (12-24 months- ages 12-15 months at enrollment) living in socioeconomically disadvantaged homes

the purpose of this study is to examine the relationships among sleep characteristics, stress (allostatic load), and health among toddlers living in economically stressed communities. sleep difficulty, including short sleep duration and poor sleep efficiency, is closely related to measures of stress, including interleukin (il-6), cortisol, c-reactive proteins (crp), secretory immunoglobulin a (siga), and body mass index (bmi) and may therefore contribute to 'wear and tear' on the body (allostatic load), a problem that places children at high risk of physical and mental health problems. young children who live with socioeconomic adversity are especially vulnerable to both sleep difficulty and higher levels of physiologic stress (allostatic load).

Eligibility criteria:
inclusion criteria: * toddlers (12-24 months- ages 12-15 months at enrollment) living in socioeconomically disadvantaged homes. exclusion criteria: * if the toddler has a diagnosis of sleep apnea or has another documented medical condition affecting sleep.

Keywords: economically stressed communities
a study to evaluate bleeding patterns with three different doses of dr-1031 compared to seasonale

Conditions: Breakthrough Bleeding

Summary: this is a 4-arm study to evaluate and compare bleeding patterns between three different doses of dr-1031 oral contraceptive with seasonale oral contraceptive. study participants will receive physical and gynecological exams, including pap smear. during the study, all participants will be required to complete a diary

this phase 2, prospective, multicenter, double-blinded, randomized study is designed to evaluate and compare bleeding patterns in women using one of three different doses of dr-1031 oral contraceptive with seasonale oral contraceptive. patients who meet all study entrance criteria will be randomly assigned to one of four treatment groups, the overall study duration will be approximately 9 months; this will include a screening period of approximately 4 weeks, a run-in period of 4 weeks, a treatment period of approximately 6 months (two,91-day cycles) and a final study visit occurring 14-21 days after completion of study drug.

Eligibility criteria:
inclusion criteria: * premenopausal * not pregnant or breastfeeding * agree to use back-up non-hormonal contraception for study period exclusion criteria: * any contraindication to the use of oral contraceptives * pregnancy within the last 3 months * smoking \>10 cigarettes per day

Keywords: oral contraceptives breakthrough bleeding spotting
dose ranging study of the glp-1 agonist ave0010 in metformin-treated subjects with type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: to evaluate the dose-response relationship of ave0010 administered once daily and twice daily with chronic dosing in metformin-treated subjects with type 2 diabetes


Eligibility criteria:
inclusion criteria: * males, females, age 30, - 75 years, type 2 diabetes mellitus, treated with metformin ≥1.0 g/day, at a stable dose for at least 3 months, bmi 25 - 40 kg/m2, hba1c ≥7.0% and \<9.0%. exclusion criteria: * type 1 diabetes, pregnancy, lactation, women of childbearing potential, treatment with other antidiabetic agents than metformin, history of metabolic acidosis, hemoglobinopathy or hemolytic anemia, clinically significant medical abnormalities.

Keywords: type 2 diabetes