Kornimate/medical-research-clean huggingface dataset:
cognitive stimulation and chemobrain. an innovative intervention for cancer survivors

Conditions: Breast Cancer; Cognitive Decline

Summary: the present study aims to establish a non-pharmacological alternative in alleviating cognitive deterioration derived from undergoing chemotherapy treatment. thus, the effectiveness of a personalized and computerized cognitive stimulation program in breast cancer survivors is assessed.

a phase i/ii/iii clinical trial is proposed in which the first two phases will serve to evaluate the safety of the intervention and the maximum tolerated time of computerized cognitive training per session in the absence of adverse effects. the third phase will consist of a double-blind randomized controlled trial where the effectiveness of the personalized and self-administered computerized cognitive stimulation program will be evaluated. phase i. based on a dose-escalation 3+3 design, experienced fatigue or adverse effects will be measured after succeeding 15 minutes cognitive stimulation training blocks. the training dose will be set to a block before extreme fatigue or notable adverse effect has been reported by two or more participants. a trained psychologist will supervise the process. phase ii. to evaluate the effectiveness of the intervention, 20 participants will undertake an interspersed training day and evaluation day through 15 consecutive days. in this way, a total of 8 evaluation sessions (day 1, 3, 5, 7, 9, 11, 13, and 15) and 7 cognitive stimulation sessions (day 2, 4, 6, 8, 10, 12, and 14) will be carried out. a trained psychologist will supervise every step of the process. phase iii. an 8-week personalized and computerized cognitive stimulation program will be established, where the training time per session will be as determined on phase i. 120 participants will be randomized 1:1 ratio to an intervention or active control group. all participants will undertake a pre and post-test, with a total of 40 training sessions (monday to friday) during 8 weeks. although this phase is set to be an online home-based stage, the responsible psychologist will be monitoring participants' performance and will periodically contact participants via telephone.

Eligibility criteria:
inclusion criteria: * have been diagnosed with breast cancer. * having undergone chemotherapy. * report objective or subjective complaints of cognitive impairment. exclusion criteria: * metastases or brain tumors. * existence of a relevant medical, psychiatric, or neurological disorder. * significant visual or motor impairments. * history of alcohol or drug abuse or dependence. * be receiving another cognitive stimulation intervention.

Keywords: breast cancer cancer survivors chemobrain cognitive stimulation online intervention
study to assess safety and pharmacokinetics of double-blind s-707106 alone and in combination with open-label metformin in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to determine the safety and pharmacokinetics of double-blind s-707106 alone and in combination with open-label metformin in patients with type 2 diabetes mellitus

safety will be evaluated by monitoring of treatment-emergent adverse events, clinical laboratory evaluations, vital signs, 12-lead electrocardiograms, 24-hour telemetry monitoring, and physical exams. specific study withdrawal criteria during washout periods of metformin have been established for loss of glycemic control, i.e., glucose monitoring. pharmacokinetic assessments of monotherapy cohort versus add-on therapy will be performed

Eligibility criteria:
inclusion criteria: * body mass index range (25.0-38 kg/m2) with type 2 diabetes mellitus receiving stable dose of metformin bid for the previous 60 days for glucose control * patients sterile or agree to use approved method of contraception * no clinically significant abnormal tests * hemoglobin a1c level ≤10.5% exclusion criteria: * history of clinical manifestations of significant metabolic, hepatic, renal, and hematological pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders other than type 2 diabetes mellitus * uncontrolled diabetes * exclusionary labs - fasting blood sugar, low hemoglobin, elevated liver function tests, positive result for human immunodeficiency virus, hepatitis b surface antigen, and anti-hepatitis c virus * low creatinine clearance * history of myocardial infarction within past 90 days or other cardiovascular conditions * prior exposure to s-707106 * treatment with investigational study drug within 30 days of study admission day

Keywords: metformin
liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in africa, asia, europe, and north and south america. the aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: - type 2 diabetes - age min. 50 years at screening and concomitant cardiovascular, cerebrovascular or peripheral vascular disease or chronic renal failure or chronic heart failure or age min. 60 years at screening and other specified risk factors of cardiovascular disease - hba1c: 7.0% or above - anti-diabetic drug naive or treated with one or more oral anti-diabetic drugs (oads) or treated with human nph insulin or long-acting insulin analogue or premixed insulin, alone or in combination with oad(s) exclusion criteria: - type 1 diabetes - use of a glucagon-like peptide-1 (glp-1) receptor agonist (exenatide, liraglutide or other) or pramlintide or any dipeptidyl peptidase 4 (dpp-4) inhibitor within the 3 months prior to screening (trial start) - use of insulin other than human nph insulin or long-acting insulin analogue or premixed insulin within 3 months prior to screening. short-term use of other insulin during this period in connection with intercurrent illness is allowed, at investigator's discretion
epidural stimulation for upper extremity function

Conditions: Spinal Cord Injury Cervical; Tetraplegia

Summary: restoring upper extremity function in patients with cervical spinal cord injury is extremely important for patients' independence and quality of life. at present, there are limited options for hand or arm reanimation in this patient population. nerve transfer is one such option that can partially restore the natural movement of hand or arm function in select patients. the investigators are interested in understanding whether recovery of hand or arm motor function after nerve transfer can be augmented by cervical epidural spinal cord stimulation.

the study will enroll up to 20 participants in a single arm prospective clinical study. potential participants will have already had a nerve transfer surgery more than 6 months prior to enrollment and will have also completed post-nerve transfer physical /occupational neurorehabilitation. at baseline, upper extremity muscle strength, muscle force and nerve health with needle electromyography and neuroimaging will be tested. patients will undergo percutaneous (temporary) spinal cord stimulator leads placement in the cervical supralesional spine region. week 0-4: weekly testing of motor function and muscle contraction force with the stimulation turned on versus turned off will be performed. stimulation parameters for each target upper extremity muscle will also be documented. temporary leads will be removed after approximately 4 weeks. at the last research visit at approximately 6-7 weeks post leads placement muscle strength/force will be assessed to determine the duration of the stimulation effect (if it is sustained). to assess any improvement of nerve health, neuroimaging and electromyography will also be performed.

Eligibility criteria:
inclusion criteria: * age ≥18 years and ≤65 * provides informed consent * history of upper extremity nerve transfer \> 6 months prior to enrollment * completion of standard post-nerve transfer occupational therapy * baseline upper extremity strength of \< 5/5 grade with the mrc * scheduled to undergo a cervical spinal cord stimulation procedure for chronic pain refractory to first line therapy * willing and able to adhere to the study protocol exclusion criteria: * central nervous system (cns) malignancy * a contraindication to the scs procedure * diagnosis that precludes the patient from full participation in the protocol * a functional implanted device (pacemaker, vagus nerve device, baclofen pump) * botulinum toxin injection in upper extremity muscles \< 6 months prior to enrollment * for female participants, current/planned pregnancy (females of childbearing age will be asked to take a pregnancy test on the day of the intervention) * other factors that prevent participation in the opinion of the surgeon-principal investigator

Keywords: spinal cord stimulation percutaneous peripheral nerve transfer
methadone maintenance treatment outcome study in taiwan

Conditions: Heroin Addiction

Summary: opioid abuse is a complex problem, which not only impacts on the affected individuals' physical and psychological health, but also threatens public security and the productivity of the society. further, through needle sharing and sexual contacts, injecting drug users (idus) have become laden with hiv and hiv related health problems, representing a serious public health threat all over the world. in taiwan, since the identification of the first hiv-infected idu in 1987, the incident cases have continued to increase, reaching a height of 2,461 in 2005. in order to contain the epidemics of hiv among idus, and to prevent its spread to the population in general, the center for disease control (cdc) collaborated with the department of justice to initiate and implement a number of harm reduction programs in 2005. the fact that opioid addiction is officially treated as a health rather than a legal issue itself represents a remarkable milestone in taiwan. among these harm reduction programs, including needle and syringe exchange for idus as well as substitution treatment approaches for opioid dependence, methadone maintenance treatment (mmt) perhaps represents the most most important and most crucial component. remarkably, in a relatively short time span, more than 60 mmt programs were established, which enrolled more than 15,000 heroin addicts. this notwithstanding, the overall and differential effectiveness of these mmt service delivery systems, as well as the characteristics of these programs and the patients that might contribute toward treatment response or failure remain largely unknown. such knowledge base is crucial for establishing standardized and feasible outcome evaluation processes for opioid addicts receiving mmt programs, as well as for the further improvement of the efficacy and effectiveness of these programs, in taiwan. in order to address some of these issues, this study adopts a multi-site, prospective clinical follow-up design. it aims at establishing a research network for examining mmt outcome, developing standardized mmt outcome assessment instruments and procedures, and identifying predictors of mmt outcome. the findings may contribute to the better understanding of the characteristics of opioid addicts, the effectiveness of mmt and remaining service needs for opioid addicts in taiwan.


Eligibility criteria:
inclusion criteria: * be 18 years or older. * be fulfilling the diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria of opiate dependence. * be agree to and capable of signing informed consent form that has been approved by an institution review board. exclusion criteria: * have ever participated in the study at one of the collaborative hospitals/clinics. * be expecting to discontinue methadone treatment for any reason (leaving the methadone clinic's geographic area, pending legal action, etc.) in the following 3 months.
the efficacy of core stability training in rehabilitation

Conditions: Stroke; Hip Fractures

Summary: the goal of the study is to verify the efficacy of core stability training in rehabilitation of patients after hip fracture and in patients after stroke. the study will compare one group using traditional rehabilitation and another one with the addiction of an approach named "omino", which is a kind of "health education" for the patient to the use of "core stability".


Eligibility criteria:
inclusion criteria: * age:18/90 * hip fracture * stroke * consensus released exclusion criteria: * mmse\<24 * dementia * no trunk control * no deambulation * clinical reasons * consensus not released.
therapeutic drug monitoring (tdm) of voriconazole and correlation with cyp2c19 genotype in korean populations

Conditions: Mycoses; Neutropenia; Bone Marrow Transplantation

Summary: voriconazole (vcz), the antifungal drug active against candida and aspergillus is a substrate of cyp2c19, whose proportion of poor metabolizers is about \~20% in asian population. the auc's of vcz differs over 4 folds by cyp2c19 genotypes of homozygotic wild type, heterozygote, and homozygotic poor metabolizers. the asian population enrolled in the metabolism of vcz were mainly japanese and chinese, without korean subjects. the proportion of poor metabolizers in korean population is known to be around 12% (pharmacogenetics. 1996 dec;6(6):547-51). the importance of cyp2c19 genotypes on the pharmacokinetics (pk) of voriconazole is well established, hence, it is desirable to individualize the dosage regimen of vcz according to the genotypes of patients. fungal infection in immunocompromised patients is a life threatening condition which needs critical care. although the pk change by genotypes are well known, its clinical implication or need for different dosage regimen by genotypes is not established, yet.

the investigators are trying to set up voriconazole (vcz) therapeutic drug monitoring (tdm) \& establish relationship with efficacy and safety in korea. the investigators also want to propose the optimal dosage regimen for vcz over different genotypes of cyp2c19 in the immunocompromised patients in korea.

Eligibility criteria:
inclusion criteria: * immunocompromised adults who are treated with voriconazole due to proven or probable invasive fungal infections exclusion criteria: * patients who have been treated with other investigational drugs * patients with liver dysfunction (aminotransferase level ≥ 5 times the upper limit of normal, bilirubin or alkaline phosphatase level \> 3 times the upper limit of normal) * patients with renal dysfunction (cr level \> 2.5 times the upper limit of normal) * pregnant women * patients younger than 15 years of age

Keywords: mycoses voriconazole
a multi-center study of ibrutinib in combination with medi4736 in subjects with relapsed or refractory lymphomas

Conditions: Diffuse Large B-Cell Lymphoma; Follicular Lymphoma

Summary: the purpose of this study is to evaluate the efficacy, safety and tolerability of the combination treatment of ibrutinib and medi4736 in subjects with relapsed or refractory lymphomas.


Eligibility criteria:
inclusion criteria: * pathologically documented relapsed or refractory diffuse large b-cell lymphoma (dlbcl) or follicular lymphoma (fl) * measurable disease sites on ct scan (\>1.5 cm in longest dimension) * adequate hematologic function: 1. absolute neutrophil count \>1500 cells/mm3 2. platelets \>50000 cells/mm3 3. hemoglobin \>8.0 g/dl * adequate hepatic and renal function: 1. ast or alt ≤2.5 x uln 2. bilirubin ≤1.5 x uln 3. estimated creatinine clearance (cockcroft-gault) \>40 ml/min * ecog 0 or 1 exclusion criteria: * received prior therapies: ibrutinib, or other btk inhibitor and/or anti-pd1, anti-pd-l1, anti-pd-l2, anti-cd137, or ctla-4 antibody * requires treatment or prophylaxis with a strong cytochrome p450 (cyp) 3a inhibitor * primary cns lymphoma or evidence of cns involvement by lymphoma
randomized controlled trial to evaluate of dexmedetomidine for the effect on operative visibility in patients undergoing endoscopic sinus surgery

Conditions: Chronic Sinusitis

Summary: various maneuvers are commonly used to achieve the ideal operative field necessary for successful endoscopic sinus surgery (ess). dexmedetomidine, a potent alpha2 adrenoceptor agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine response. and dexmedetomidine has an effect of peripheral vasoconstriction thus it is thus theologically appropriate for reducing bleeding during intranasal operation. the aim of this study is to compare the effect of dexmedetomidine, an alpha2-adrenoreceptor agonist, on intraoperative bleeding, propofol requirement and postoperative profiles to remifentanil , an ultrashort-acting opioid.


Eligibility criteria:
inclusion criteria: * asa ⅰ-ⅱ * aged between 20 and 70 year * general anesthesia for endoscopic sinus surgery exclusion criteria: * body mass index \>30 * congestive heart failure, sinus bradycardia(\<50 bpm), uncontrolled hypertension, * coagulopathy * drug addiction * pregnancy * allergic fungal infection
computational cognitive training to boost reward responsiveness in anhedonic patients

Conditions: Anhedonia; Depression

Summary: anhedonia, i.e., reduced positive mood and decreased sensitivity to rewards, is observed in many psychiatric illnesses, particularly depression and anxiety disorders. untreated anhedonia predicts worse clinical outcomes and poorer response to treatment, yet cognitive behavioral treatment approaches to target anhedonia are fraught with poor patient compliance in real-life settings. the proposed study aims to address this gap by 1) testing the usefulness of a non-invasive, computationally informed, cognitive training in boosting reward sensitivity and reducing anhedonia in depressed and anxious patients, and 2) delineating the neurocomputational mechanisms of change associated with such intervention. in other words, can we train the brain to obtain rewards and boost positive mood among depressed and anxious individuals? this project will help to develop a computational training protocol aimed at reducing anhedonia and improving existing interventions for psychiatric conditions characterized by reward processing deficits. long-term goals include expanding this framework to a broader range of appetitive and social stimuli to develop precise cognitive training tools to treat anhedonia.


Eligibility criteria:
inclusion criteria: * age 18-65 (all races, both males and females will be included) * current diagnosis of major depressive disorder (mdd) or generalized anxiety disorder (gad) * a score \< 7 on the snaith-hamilton pleasure scale (shaps) or \< 25 on the positive affect subscale from the positive and negative affect scale (panas) * sufficient proficiency in english language to understand and complete informed consent, interviews, questionnaires, and all other study procedures. * having normal or corrected vision * having normal or corrected hearing exclusion criteria: * endorsement of past or current psychotic or bipolar disorder. * endorsement of recent severe alcohol or substance use disorder (past 3 months). * inability to discontinue for 48 hours prior to scan any medications incompatible with measuring reliable/interpretable neural activity (e.g., e.g., benzodiazepines/beta-blockers, atypical anti-depressants, anxiolytics and sedative hypnotics, antipsychotics, and opioid analgesics) * being unsafe to undergo functional magnetic resonance imaging (fmri), i.e., being pregnant, presence of non-removable metal in body, medical conditions that are incompatible with safe mri (e.g., claustrophobia, inability to lie still on one's back for approximately 60 minutes; prior neurosurgery) * clinical conditions assessed by the interviewer that necessitate more imminent clinical care (e.g., active suicidal ideation): these criteria are in place so participants with these other, more several symptoms can be referred for appropriate mental health services.
comparison of two different skin-to-skin contact techniques: sustained diagonal flexion vs. traditional

Conditions: Skin-to-skin; Preterm Birth

Summary: this is a prospective, controlled randomized study designed to compare the effects of two methods of skin-to-skin positioning of preterm infants: the prone positioning method currently used (according to the world health organization's recommendations) and the recent "sustained diagonal flexion" method (sdf) on the daily duration of skin-to-skin contact.

this is a prospective, controlled, randomized, non-blinded trial, recruiting premature infants between 27- 34 weeks of gestational age during the first 4 days of life. 80 parent-infant dyads will be recruited in the department of neonatology (ga between 27 and 34 weeks) and randomly divided in two groups. each dyads will be assigned to one of the two skin-to-skin positions. the study aims to investigate if the sustained diagonal flexion method (sdf) provides additional benefits for both the child and their parents, such as increase in daily skin-to-skin time and its continuation after discharge. the investigators will analyze the daily duration of skin-to-skin, the cardiorespiratory stability of the child (number of incidents recorded by standard monitoring), the presence of pain during: installation /skin-to-skin/ after the return to the incubator, the continuation of skin-to-skin, breastfeeding after discharge, the risk of postpartum depression in the mother, parental stress, joint mobility and muscle tension of the child and their parents, and also the comfort and satisfaction with the type of skin-to-skin.

Eligibility criteria:
inclusion criteria: * premature infant born between 27 and 34 weeks of gestational age * aged between 24 hours and maximum 4 days at the beginning of the study * approval from the neonatologist in charge of the patient to participate in the study * informed consent of the parents to participate in the study * at least one of the two parents must have a good knowledge of french. exclusion criteria: * infant with severe secondary neurological or medical conditions, e.g., neurological deficits due to vascular hemorrhage (grade iii or iv) * infant or parent who requires or has required surgery during their neonatal stay * triplets * parent who suffers from a physical disability or severe psychological illness, a psychosocial situation that does not allow skin-to-skin care * infant with an arterial line

Keywords: kangaroo care skin-to-skin sustained diagonal flexion skin-to-skin contact time joint mobility and muscular tension assessment preterm family centered care
comparison of anastrozole verses clomiphene citrate in stimulating follicular growth and ovulation in infertile women with ovulatory dysfunction

Conditions: Anovulation

Summary: the purpose of this study is to investigate and compare the safety and efficacy of various doses of the aromatase inhibitor (anastrozole) versus clomiphene citrate in stimulating follicular growth and ovulation in infertile women with ovulatory dysfunction.


Eligibility criteria:
inclusion criteria: * aged 18-40 years * ovulatory dysfunction characterized by irregular and/or extended cycles * non-smoker exclusion criteria: * no previous gonadotropin treatment * no more than 6 previous clomiphene treatment cycles