Kornimate/medical-research-clean huggingface dataset:
nature and animal-assisted activities

Conditions: Neuropsychiatric Syndrome; Autism Spectrum Disorder

Summary: neuropsychiatric impairments in young adults are common and can involve social withdrawal, and difficulties in receiving support from healthcare and municipal social care services. collaboration is needed, but knowledge gaps exist concerning effective interventions. participation in meaningful activities, as a complement to other treatment strategies can be a step towards studies/work. the aim of the trial is to explore the feasibility of a structured nature and animal-based activity on a farm for young adults with neuropsychiatric impairments. the intervention involves participation in nature and animal-assisted group activities, twice a week for 12 weeks. data consists of interviews with participants prior to and after the intervention, as well as one year later. the one-year follow-up focus is on life situation, changes in everyday life and experiences of the intervention. in addition, interview-based experiences of the ordinary staff and supervisors on the farm are included. analysis will be carried out with qualitative content analysis, as well as health-economic calculations.


Eligibility criteria:
inclusion criteria: * 18-30 years * autism spectrum disorder * no occupation/employment/education over the last year * social insurance benefits * interest in being with animals exclusion criteria: * ongoing active drug abuse * severe psychiatric comorbidity

Keywords: complementary therapies feasability young adults
the efficacy and safety of switching to flumatinib versus dasatinib after imatinib-related low-grade adverse events in cml-cp patients

Conditions: Chronic Myeloid Leukemia in Chronic Phase

Summary: the purpose of this study is to explore the efficacy and safety of switching to flumatinib versus dasatinib after imatinib-related low-grade adverse events in patients with chronic myeloid leukemia in chronic phase (cml-cp) in china. this is a post-marketing, interventional, double-arm, prospective, open-label, randomized controlled study in cml-cp patients in china. patients will be recruited consecutively from the study sites during the enrollment period. the enrolled patients will be given flumatinib or dasatinib under the conditions of informed consent and frequent monitoring according to the clinical guideline.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * diagnosis of cml-cp with ph+; * ecog 0, 1, or 2; * patients with imatinib-related low-grade adverse events for more than 12 months and ae lasting for at least 2 months, or relapsed at least 3 times in the past 12 months; * ability to provide written informed consent prior to any study related screening procedures being done exclusion criteria: * previously documented t315i mutation; * previous treatment with any other tyrosine kinase inhibitor except for imatinib; * prior accelerated phase or blast phase cml; * loss of chr or cytogenetic response

Keywords: chronic myeloid leukemia in chronic phase imatinib flumatinib dasatinib
a study of mianserin in combination with ssris in depression with sleep problems

Conditions: Depression

Summary: patients with depression with sleep problems have functional abnormalities of 5-ht and ne neurotransmitters, and the nassa class antidepressant mianserin has an ameliorative effect on sleep problems along with antidepressant. however, whether mianserin can improve cognitive function in patients still needs to be explored. the benzodiazepine lorazepam can play a central inhibitory role and has good therapeutic effect on insomnia. the mechanism of action of mianserin and lorazepam is different, and there are few comparative studies related to the combination of the two with ssri drugs for the treatment of depressed patients with sleep problems, and it is unclear whether there are differences in their efficacy and safety. therefore, to address the above scientific questions, this study was designed to include 100 patients aged 18-60 years with depression with sleep problems, randomly divided into two groups and treated with mianserin + escitalopram or lorazepam + escitalopram, respectively, and followed up for 8 weeks to assess depression and anxiety symptoms, sleep, cognitive function and drug safety. to compare the efficacy and safety of the two regimens in depressed patients with sleep problems and to provide a scientific basis for clinical intervention in depressed patients with sleep problems.


Eligibility criteria:
inclusion criteria: * meeting the diagnostic criteria for major depressive disorder (dsm-5) with a hamd-17 score ≥ 17 and a hama score ≥ 14. * having complaints of sleep problems or psqi scores \>7. * han chinese, age 18-60 years old, junior high school education or above. * no previous manic episodes or manifestations of mild manic episodes. * not taking antidepressants and sedative-hypnotic drugs in the last 2 weeks, or a 7-day cleansing period for those taking drugs. * no use of convulsion-free electroconvulsive therapy (mect) within 8 weeks * those who voluntarily participated in the study with the patient's informed consent. exclusion criteria: * dsm-5 organic mood disorders; psychiatric disorders associated with somatic diseases; psychiatric disorders due to psychoactive substances. * those with contraindications to escitalopram, mianserin, lorazepam medications. * family history of psychiatric or other somatic disorders. * those with excessive psychiatric symptoms unable to complete the interview or unable to understand the content of the scale * pregnant and lactating females. * those who cannot cooperate with the experimental procedure and cannot cooperate effectively.
daratumumab-containing induction effects on stem cells mobilization, collection and engraftment in newly diagnosed multiple myeloma patients.

Conditions: Multiple Myeloma; Daratumumab; Autologous Stem Cell Transplantation; Leukapheresis

Summary: daratumumab is a human first-in-class monoclonal antibody that targets a cluster of differentiation (cd) 38, a cell surface protein that is overexpressed on multiple myeloma (mm) cells, showing significant activity in relapsed/refractory disease. more recently, it was demonstrated that the addition of daratumumab to pre-autologous hematopoietic stem cell transplant (asct) induction regimens in newly diagnosed multiple myeloma increased the rate of complete responses and disease-free survival. however, in consideration of the expression of cd38 antigen also by stem cells, daratumumab could exert effects on their mobilization, collection, and engraftment. the primary objective of this retrospective/prospective observational study is to investigate the impact of adding daratumumab to standard induction regimens (vtd:bortezomib-thalidomide and dexamethasone, vd: bortezomib and dexamethasone) on stem cell mobilization in patients with newly diagnosed multiple myeloma (ndmm) who are candidates for asct.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * ndmm candidate to stem cell mobilization, collection, and asct who received a daratumumab-containing induction regimen. * signed written informed consent to study participation. exclusion criteria: * age \<18 y.o. * inability to obtain written informed consent. * patients not proceeding to stem cell mobilization because of disease progression. * patients not eligible for high-dose cyclophosphamide according to baseline cardiologic evaluation.
effects of ovarian hormone suppression on vascular and cognitive function

Conditions: Cognitive Impairment; Estrogen Deficiency; Menopause; Endothelial Dysfunction; Vascular Stiffness

Summary: complaints about memory and thinking are common in women as they go through menopause. the female hormone estrogen is important for both the health of both the brain and the blood vessels. in alzheimer's disease there is damage to the blood vessels in the brain. this study will look at how the loss of the female hormone estrogen affects brain function and the health of blood vessels.


Eligibility criteria:
inclusion criteria: * stages of reproductive aging workshop (straw+10) peak or late reproductive stage (-4, -3b or -3a) * healthy based on medical history, physical examination and standard blood chemistries * normotensive (resting blood pressure \<140/90 mmhg) * normoglycemia (fasting glucose \<110mg/dl and hemoglobin a1c\<6.5%) * non-smoker (for at least 12 months) exclusion criteria: * serum follical stimulating hormone (fsh) \>25miu/ml measured during the first 5 days of the menstrual cycle * use of hormonal therapy within the past 3 months * use of antihypertensive or lipid-lowering medications * pregnant or lactating, or planning to become pregnant during the study period * known hypersensitivity to any of the study medications * abnormal vaginal bleeding * history of venous thromboembolism or hormone-sensitive cancer * history of neurologic disease or major psychiatric illness * history of diagnosed learning disability or less than high-school education * contraindication to magnetic resonance imaging (mri) scanning * depression (center for epidemiological studies - depression (cesd) score \>16) * significant cognitive impairment (mini mental state examination (mmse) score \<27) * severe osteopenia or osteoporosis (proximal femur or lumbar spine t-score \< -2.0) * body mass index (bmi) \>40kg/m2

Keywords: cognitive impairment menopause estrogen functional mri executive function endothelial function arterial stiffness
comparison of perioperative outcomes between energy device during laparoscopic gastrectomy

Conditions: Postoperative Inflammation; Postoperative Fever

Summary: to find out which instrument can be much better for laparoscopic gastrectomy among harmonic scalpel, ligasure maryland, thunderbeat comparing postoperative crp level in each group

to find out which instrument can be much better for laparoscopic gastrectomy among harmonic scalpel, ligasure maryland, thunderbeat comparing postoperative crp level in each group 1. post operative 2nd day crp level 2. post operative 4th day crp level 3. post operative il-6, 10 level in 2nd, 4th day

Eligibility criteria:
inclusion criteria: * pathologically proven adenocarcinoma in stomach * patients who are expected for r0 resection with distal gastrectomy * pre-operative clinical stage should be stage i * patients who is able to be followed up with in postoperative 30 days * patients whose crp is normal before surgery exclusion criteria: * patients who had an abdominal surgery * patients who received chemotherapy, radiotherapy before surgery * patients who received esd before surgery * patients who had an ascites on pre-operative ct scan * liver cirrhosis * cardiovascular disease (ejection fraction\<50%) * serum creatinine \> 1.4 mg/dl or bun\>26mg/dl * pt inr \>1.2 or aptt\>45sec * uncontrolled diabetes * crohn's disease, ulcerative colitis * patients who receives anti-coagulants * patients who need pre-operative steroid booster because of steroid treatment * pregnancy * patients who have allergic reaction to iodine

Keywords: fever, inflammation
a crossover study of the acute effects of olanzapine in healthy volunteers

Conditions: Insulin Resistance; Diabetes Mellitus

Summary: the purpose of this clinical research study is to examine the acute hormonal and metabolic effects of the drug olanzapine, as well as appetite effects, in healthy volunteers. the hypotheses to be tested are that: (1) olanzapine rapidly attenuates plasma leptin and (2) rapidly alters glucose tolerance in healthy volunteers. these questions will be answered by having volunteers undergo two glucose tolerance tests in a crossover study design.


Eligibility criteria:
inclusion criteria: * healthy volunteer * body mass index of 18.5-25 kilograms per square meter * must be able to swallow tablets * able to give informed consent exclusion criteria: * any dsm-iv tr axis i psychiatric disorder (except nicotine dependence) * presence of any medical disorder that may confound the assessment of relevant biologic measures, including: significant organ system dysfunction, metabolic diseases, type 1 diabetes mellitus, type 2 diabetes mellitus, pregnancy, endocrine disease, coagulopathy, clinically significant anemia, or acute infection * subjects who have taken any antipsychotic medication within the last 6 months * personal or family history of seizures and/or cardiac arrhythmias

Keywords: insulin resistance diabetes mellitus antipsychotic
designing and pilot testing a just-in-time adaptive intervention (jitai) for adolescent depression treatment in primary care

Conditions: Depression - Major Depressive Disorder

Summary: the goal of this clinical trial is to learn if a tailored smartphone intervention called sidekick can help improve sleep and physical activity for teenagers in depression treatment. the main question it aims to answer is: does sidekick help teens improve sleep or physical activity? teen participants will be asked to complete surveys about how they are feeling and doing at the beginning of the study and throughout their participation. all teen participants will be able to use the sidekick app during the study.


Eligibility criteria:
inclusion criteria: 1. english-speaking 2. 13 to 17 years old 3. phq-8 score ≥5 4. phq-8 rating of ≥1 on anhedonia, sleep, or fatigue items 5. own a personal smartphone exclusion criteria: 1. active safety concerns (e.g., acute suicidal ideation) 2. diagnosed developmental disability (e.g., autism spectrum) 3. primary mental health diagnosis other than mdd according to baseline mini-international neuropsychiatric interview (mini) (comorbidity allowed when mdd primary) 4. sleep disorder from another medical cause 5. inability to engage in moderate exercise because of medical concerns;
sugammadex vs placebo to prevent residual neuromuscular block

Conditions: General Surgery

Summary: the study is designed to determine whether patients who receive sugammadex immediately after tracheal extubation will exhibit a decrease in the incidence of postoperative residual paralysis and an associated decrease in the incidence of postoperative respiratory depression.


Eligibility criteria:
inclusion criteria: * patients undergoing surgery with general anesthesia * patients weighing \> or = 80 pounds * patients not intubated prior to surgery * patients who are able to give informed consent exclusion criteria: * patients unable to give informed consent. * patients whose condition will not allow for placement of the electrode padset of exspiron * patients who are anticipated to remain intubated in recovery period.

Keywords: postoperative respiratory depression neuromuscular agents
clinical study of tuti-16 in hiv-1 infected and uninfected subjects

Conditions: HIV Infections

Summary: this protocol represents the second in human study of tuti-16, and is being conducted to continue to gather safety and human immunogenicity (anti-hiv-1 tat titers) data of subcutaneously administered tuti-16.

hiv-1 tat protein, a virally encoded toxin, is secreted by hiv-1 infected cells and acts on uninfected cells, rendering them permissive for hiv-1 replication. hiv-1 tat enhances chronic viral replication and induces immune suppression. antibodies to tat inhibit this tat-mediated transcellular activation in vitro and minimize chronic plasma viremia. hiv-1 tat activities can be blocked in vitro and in vivo by anti-tat antibodies. the thymon universal tat immunogen (tuti-16) is a fully synthetic, self-adjuvanting lipopeptide vaccine that is water soluble and administered by subcutaneous injection. in preclinical studies, a priming dose and a three week boost in rats induced a high titer antibody response to the eight known distinct epitope variants of hiv-1 tat protein. these antibodies block the function of the hiv-1 tat protein (toxin), which is essential to the maintenance of chronic hiv-1 viremia. therefore, tuti-16 has potential as a therapeutic vaccine for hiv-1 in humans.

Eligibility criteria:
inclusion criteria: * males and females * age ≥18 and ≤50 years at screening * hiv negative healthy subjects or hiv-1 seropositive subjects on effective art for \>2 months (undetectable hiv plasma viremia), viral set point before art \>3,000 * cd4+ t-cell count ≥ 500/mm3. exclusion criteria: * pregnant/nursing females * positive for hbv or hcv * acute herpetic event * any clinically significant out-of range laboratory value * routine or prn consumption of immune suppressive medications that the subject is unable or unwilling to discontinue during the study * participation in another investigational drug/vaccine study within 30 days preceding the first injection of investigational agent in this study.

Keywords: hiv vaccine lipopeptide tat tuti-16 thymon
korean vascular intervention society multicenter registry study on outcomes of endovascular therapy in lower limb artery diseases (k-vis ella): (a retrospective & prospective observational study)

Conditions: Peripheral Arterial Disease(PAD)

Summary: 1. study design: multicenter retrospective and prospective observational study 2. study cohort : 1. retrospective cohort: this cohort retrospectively enrolls patients with lower extremity artery disease who underwent endovascular treatment from january 2006 to the date of approval by irb in the participating hospitals. informed consent was waived by irb. 2. prospective cohort: this cohort prospectively enrolls patients with lower extremity artery disease who undergo endovascular treatment from the date of approval by irb to july, 2018 in the participating hospitals. informed consent will be obtained prior to enrollment. 3. baseline clinical and lesion characteristics, procedural and post-procedural data, clinical outcomes, hemodynamic, and imaging follow-up data are investigated. primary patency and target lesion revascularization rates of the total cohort and patient subgroups are evaluated. risk factors of restenosis and target lesion revascularization are determined.

this is an observational study. the study includes patients who underwent endovascular treatments for lower extremity artery diseases and investigates immediate and late outcomes of the treatments. the investigator does not assign any specific interventions.

Eligibility criteria:
inclusion criteria: * retrospective data patients who underwent or attempted endovascular treatment for symptomatic peripheral artery disease from january 2006 until irb approval date * prospective data 1. age 20 years of older 2. patients in the treatment or trying about symptomatic peripheral artery disease from irb approval date 3. symptomatic peripheral artery disease: * intermittent claudication (rutherford category 1 to 3) * critical limb ischemia (rutherford category 4 to 6) exclusion criteria: 1. pregnant women or women with potential childbearing 2. moderate alzheimer's disease, mental illness or neurological disease of more than those who can not understand the purpose of this clinical trials and methods 3. life expectancy \<1 year due to comorbidity
adverse radiation effects after gamma knife radio surgery and hyperbaric oxygen therapy

Conditions: Cerebral Necrosis

Summary: evaluation of clinical improvement and the reduction of edema lesion documented by magnetic resonance imaging (mri) in patients with cerebral radiation necrosis post gamma knife surgery (gks) by treatment with hyperbaric oxygen therapy (hbo)

patients will be recruited on the basis of the presence of cerebral radionecrosis post gamma knife surgery, documented by both clinical examination (rankin scale) and instrumental imaging (mri). they will be subjected to hyperbaric oxygen therapy hbo, and during treatment the patient performs clinical examination (rankin scale) for 24 sessions of hbo. then they will have a break of 10-15 days during which also performs the instrumental survey (magnetic resonance imaging). if the radionecrosis has regressed they will suspend the treatment otherwise continue up to a maximum of 40 treatment sessions of hbo

Eligibility criteria:
inclusion criteria: * between 10 and 75 years * understanding of the italian language * ability to understand the procedures and carrying out of the study * signing informed consent for adults and minors in use * underwent radiosurgery with clinical and instrumental signs of radiation necrosis exclusion criteria: * younger than 10yrs old and older than 75yrs old * not capable to understand italian language or to understand the protocol procedures and visits' scheme * informed consent not given * enrolled in another clinical trial * concomitant pathologies contraindicate hbo as: emphysema, asthma, epilepsy, claustrophobia; paul bert syndrome, lorrain smith syndrome * under disulfiram, doxorubicine, cisplatinum, mafenide acetate, bleomycins treatment * life expectancy less than 6 months * rankin scale \>5

Keywords: hyperbaric oxygen therapy; gamma knife radiosurgery
efficacy of family-based dietary counseling during pregnancy on gestational weight gain in pregnant women in a randomized controlled trial

Conditions: Pregnancy; Dietetics

Summary: the study aims to evaluate the efficacy of a family-based dietary monitoring during pregnancy on gestational weight gain in pregnant women. the study will be conducted as a randomized controlled trial, women will be randomly allocated into two groups: a group receiving family-based dietary monitoring, and a control group receiving individual dietary monitoring per standard recommendation.


Eligibility criteria:
inclusion criteria: adult (+18 years old) pregnant woman who can be accompanied by a member of the household, adult sharing at least 1 meal per day with her. affiliated to the social security. french speaking person (read/written and spoken). single pregnancy between 8 sa and 16 sa. starting bmi between 18.5 and 35 exclusion criteria: * person under legal protection or guardianship * women suffering from a disease requiring a dietary follow-up: * type 1 or type 2 diabetes. * gestational diabetes diagnosed on the basis of fasting blood sugar. * history of bariatric surgery. * eating disorders. * metabolic pathologies leading to special diets (phenylketonuria). * digestive pathologies (with an indication) with special diets * women who have lost more than 10% of their weight at the beginning of pregnancy

Keywords: gestational weight gain birth weight recommendations intervention nutrition