Kornimate/medical-research-clean huggingface dataset:
the research team aims to elucidate the impact of itbs (intermittent theta burst stimulation) on the hpa axis and post-stroke negative emotions/depression by conducting human experiments that target various brain regions.

Conditions: Stroke; Post-stroke Depression

Summary: the project team will categorize stroke patients into three groups receiving itbs stimulation targeting distinct brain regions: the cerebellum, the dorsolateral prefrontal cortex (dlpfc), and the primary motor cortex (m1), with 20 patients allocated to each group. neurofunctional scores, anxiety and depression assessments, and transcranial magnetic stimulation evoked potentials (tep) will be assessed pre- and post-treatment within each group. the relationship between anxiety and depression scores and brain network characteristics associated with emotions will be examined to investigate the impact of itbs stimulation on post-stroke negative emotions. furthermore, plasma and saliva samples will be collected from stroke patients in each group post itbs intervention. elisa will quantify acth levels in plasma and cortisol levels in both plasma and saliva, with the aim of exploring the effects of itbs stimulation on the hpa axis across different brain regions.


Eligibility criteria:
inclusion criteria: 1. initial stroke onset \<6 months, or the last stroke event occurred more than 6 months ago; 2. age ≥18 years, \<85 years (the likelihood of vci increases beyond 85 years); 3. patients with lesions in the middle cerebral artery region; 4. nihss \>4, nihss \<26; 5. mrs score ≥2; 6. completion of ct or mri; 7. no severe neurological or psychiatric disorders; no impairment of consciousness, able to cooperate with relevant treatments; no severe cognitive impairment (mmse ≥15); 8. all participants are right-handed; 9. signed informed consent form. exclusion criteria: 1. history of epilepsy or psychiatric disorders (including depression, anxiety, or schizophrenia); 2. severe comorbidities; 3. history of medication use: benzodiazepines, baclofen, or antidepressants; 4. non-compliance with the protocol; 5. acute phase of cerebral hemorrhage or acute infectious diseases; 6. severe suicidal tendencies in patients with depression; 7. severe headache, hypertension, malignant tumors, open wounds, vascular embolism, leukopenia, or other serious conditions; 8. severe alcohol abuse; 9. history of cranial surgery or presence of metal implants in the brain; 10. patients with cardiac pacemakers; 11. nihss \> 26 or mmse \< 15; 12. any condition likely to result in the patient's survival for less than 1 month; 13. pregnancy.
prevention of insomnia using a stepped care model in adults

Conditions: Sleep Disturbance

Summary: insomnia is one of the most common sleep disorders and affects approximately 10 - 40% of the population across different age groups in hong kong. our previous study has shown that insomnia can be prevented through a brief cognitive behavioral prevention program in adolescents. however, there is very limited data in the adult population. current study aims to evaluate a digital sleep-focused platform which consists of different intervention plan according to user's insomnia severity level and employed a stepped care model. thus, the effectiveness of the stepped care model will be evaluated in a real world setting using stepped wedge cluster randomized controlled design to evaluate potential preventive effect on adults who only with mild insomnia symptoms. the program will be rolled out to different districts in hong kong sequentially in 18 districts over 4 steps with a equally spaced time periods. the primary aim of this study is to evaluate the effects of a stepped-care cbt-i model in improving sleep and prevent the incidence of insomnia among participants with mild insomnia.

this interventional study will be a multicenter, assessor-blinded, pragmatic stepped-wedge cluster randomized controlled trial. a total of 18 districts will be included in the study and the randomization will be carried out based on the districts. the stepped-care cbt-i intervention will be sequentially rolled out to the 4-6 districts per step according to a computer-generated random number while the remaining clusters will continue to stay unexposed to the cbt-i intervention over the control period. therefore after 4-step exposure, all clusters will receive the stepped-care cbt-i intervention. a total of 3 follow-up assessments (post intervention, 3-month and 12-month follow up) will be conducted to assess the effectiveness and long-term effects of the stepped care model.

Eligibility criteria:
inclusion criteria: 1. chinese adults aged 18-70 years old, 2. the score of insomnia severity index \< 10. exclusion criteria: 1. present with psychotic disorders such as bipolar disorder and schizophrenia, 2. present with severe depression or suicidal ideation, 3. present with neurodegenerative diseases that prevent participant from completing the intervention (e.g., dementia and parkinson's disease). 4. unable to provide consent

Keywords: sleep disturbance stepped care model stepped wedge cluster randomized trial prevention program
a study of indinavir taken with or without dmp 266

Conditions: HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to add dmp 266 to an anti-hiv treatment program of indinavir and nucleoside reverse transcriptase inhibitors (nrtis).

in this double-blind, placebo-controlled study, 300 patients are randomized to 1 or 2 reverse transcriptase inhibitors of their choice plus blinded therapy on arm a or b as follows: arm a: dmp 266 placebo plus indinavir. arm b: dmp 266 plus indinavir. after 16 weeks, patients may switch the nrti portion of their regimen if they meet a treatment failure criterion. after the completion of the 24-week period, patients have the option to continue on open-label dmp 266 and indinavir.

Eligibility criteria:
inclusion criteria patients must have: * cd4+ cell count of at least 50 cells/mm3. * hiv rna level of at least 10,000 copies/ml by reverse transcriptase polymerase chain reaction (rt-pcr, amplicor test kit) at screening. * signed, informed consent from parent or legal guardian for patients less than 18 years of age. exclusion criteria prior medication: excluded: * dmp 266. * other nonnucleoside reverse transcriptase inhibitors. required: one or two nrtis (except zdv and d4t in combination) for a minimum of 8 weeks, within 12 weeks prior to screening.

Keywords: placebos drug therapy, combination hiv protease inhibitors indinavir reverse transcriptase inhibitors efavirenz
efficacy study of zinc supplementation on anemia, oxidative stress and inflammation in hemodialysis patients

Conditions: End Stage Renal Disease

Summary: the purpose of the study is to evaluate the effect of zinc supplementation on health status of hemodialysis patients through measurement of the following before and after zinc administration: inflammatory markers, oxidative stress markers and anemia markers. also, evaluation of quality of life of hemodialysis patients before and after zinc administration using fatigue severity scale questionnaire.


Eligibility criteria:
inclusion criteria: * under regular hemodialysis for at least 6 months. * clinically stable condition as outpatients. * zinc-deficient patients (plasma zinc concentrations less than 80 mcg/dl). exclusion criteria: * patients taking any antioxidant supplements including vitamin e, omega-3 fatty acids, green tea preparations or immunosuppressive medications within 2 months prior to enrollment in the study. * patients receiving al hydroxide phosphate binders. * hospitalization in the previous month before the onset of the trial, or having active infection. * patients with malabsorption diseases (e.g, crohn's disease), liver diseases, cancers, mental retardation, dementia or psychiatric illness.

Keywords: hemodialysis patients zinc anemia oxidative stress
development of an artificial intelligence algorithm to detect pathological repolarization disorders on the ecg and the risk of ventricular arrhythmias

Conditions: Cardiac Disease; Ventricular Arrythmia

Summary: the objective of this study is to prospectively validate in real life cohorts from various departments of the aphp our artificial intelligence (deep-learning) models allowing for : 1. automatic measurement of various ecg quantitative features, 2. identification and typing of lqt and risk of tdp.

torsade-de-pointes (tdp) are potentially fatal ventricular arrhythmias favored by a prolongation of ventricular repolarization (long qt, lqt). the different types of existing lqt derive from the inhibition of cardiac potassium currents (ikr ; iks) or the activation of a late sodium current (inal). these alterations can be of congenital origin (3 types=\>clqt-1:iks, clqt-2:ikr, clqt-3: inal) or drug-induced (dilqt, via inhibition of ikr). more than 100 drugs have marketing authorization despite a risk of tdp because they have a favorable benefit/risk ratio (e.g. hydroxychloroquine). qtc, which represents the duration of ventricular repolarization (msec) and corresponds to the time between the beginning of the qrs and the end of the t-wave, corrected by heart rate, is prolonged in all lqt. specific t-wave abnormalities as a function of the altered currents have been described and helps to discriminate clqt/dilqt types. thus, limiting the analysis of the ecg to that of the qtc is not very predictive because the information contained in an ecg is much richer and is not limited to the simple measurement of an interval. we have recently shown that analysis of ecgs using artificial intelligence (convolutional neural network, deep-learning) identifies elements of the ecg that are more discriminating in the prediction of the type of lqt and the risk of tdp, beyond of qtc. with these techniques, we have developed a model with probabilistic modules that predict the risk of tdp, identify the type of lqt (score ranging from 0 to 100%) and allow for the quantitative measurements of various common ecg parameters (including qtc, heart rate, pr and qrs). the objective of the project is to prospectively validate in real life cohorts from various departments of the aphp our model allowing for : 1. automatic qtc measurement, 2. identification and typing of lqt and risk of tdp.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * patients or subjects taken care in recruiting centres for which an ecg is indicated * no opposition to participation in the study exclusion criteria: * medical contraindication for ecg * subjects with pacemaker-driven qrs

Keywords: artificial intelligence ecg repolarization qt ventricular arrhythmias
efficacy of a preoperative virtual reality intervention as a paediatric anxiety improvement strategy

Conditions: Anxiety; Virtual Reality

Summary: this study evaluate the effectiveness of the virtual reality educational program (rvep) in the paediatric surgical prehabilitation unit to reduce the perioperative anxiety in children who undergo to elective surgery. half of the patients will received the virtual reality program, and the other half will received de common treatment.

during preoperative time, anxiety is one of the most frequent problems in children, causing an important health problem as long with pain. in the surgical fields there are two especially stressful moments for the child, the first one is the parent´s separation, and the second is the anaesthetic induction, which in up to 42% of cases can be traumatic. methods to treat paediatric anxiety have evolved in the last decades. pharmacological therapy is one of the most used methods to treat anxiety in the immediate preoperative period, but complications and unwanted side effects are described. due to this side effects, this study will evaluate the the effectiveness of the virtual reality educational program (rvep) to reduce the perioperative anxiety in children.

Eligibility criteria:
inclusion criteria: * children between 3 and 12 years old. * elective surgical intervention. * asa i-ii (classification of the american society of anesthesiologists). * surgical complexity grade i-ii according to national institute for clinical excellence of the nhs. * general anesthesia. * spanish or catalan speaking families. * understanding the study and signing the informed consent of the study by parents or legal guardians. exclusion criteria: * patients suffering from psychiatric or mental illness, psychomotor retardation, blindness or deafness. * denial of parents / legal guardians and / or children. * ambulatory surgery. * surgical intervention of the child the year before the current one.

Keywords: preanesthetic visit
closed-loop control of glucose levels (artificial pancreas) for 60 hours in adults with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. a dual-hormone closed-loop strategy would regulate glucose levels through the infusion of two hormones: insulin and glucagon. the main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and conventional insulin pump therapy to regulate glucose levels in a 60-hours in non-standardized conditions in adults with type 1 diabetes. the investigators hypothesized that 1) controlling glucose levels using single- or dual-hormone cls is feasible in free-living conditions for long period of time (60 hours); 2) dual-hormone cls is superior to single-hormone cls as assessed by reducing time spent in hypoglycemic range; 3) both single-hormone and dual-hormone cls are superior to conventional pump therapy.


Eligibility criteria:
inclusion criteria: * males and females ≥ 18 years of old. * clinical diagnosis of type 1 diabetes for at least one year. * the subject will have been on insulin pump therapy for at least 3 months. * hba1c ≤ 12%. exclusion criteria: * clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator. * recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery. * history of pheochromocytoma or insulinoma (glucagon could induce an hormonal response of these tumors) * beta-blockers at high dose based on investigator's evaluation of dosage interference with glucagon (glucagon can modify effect of beta-blockers, mostly evident at very high doses) * chronic indometacin treatment (can prevent glucagon effect on liver thus its ability to raise glucose) * warfarin chronic treatment if inr monitoring cannot be evaluated (can increase the risk of bleeding) * anticholinergic drug (risk of interaction) * pregnancy. * severe hypoglycemic episode within two weeks of screening. * current use of glucocorticoid medication (except low stable dose and inhaled steroids). * known or suspected allergy to the trial products or meal contents (gluten free menus will be available). * other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator (e.g. need for major revision of carbohydrate counting). * anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport). * failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc). * treatments that could interfere with glucagon

Keywords: type 1 diabetes hypoglycemia insulin glucagon closed-loop strategy artificial pancreas
absolutely: a temporary uterine blood supply occlusion for laparoscopic myomectomy in patients with uterine leiomyoma

Conditions: Uterine Leiomyoma; Uterine Fibroid; Leiomyoma, Uterine; Myoma;Uterus; Laparoscopic Myomectomy; Postoperative Complications; Blood Loss, Surgical; Fertility Issues; Pregnancy Complications

Summary: a phase 3 multicenter unblinded randomized controlled trial comparing the temporary uterine blood supply occlusion with conventional approach during laparoscopic myomectomy in patients with uterine leiomyoma.

primary endpoints • assess the volume of blood loss secondary endpoints * compare the rates of intra- and postoperative complications, the necessity of blood transfusion, length of surgery, length of hospital and icu stay, and leiomyoma symptoms relief * determine the procedure impact on fertility by evaluating the level of anti-mullerian hormone, pregnancy rates, pregnancy complications, and the way of delivery patients who meet study inclusion criteria will be randomized into one of two treatment arms: 1) laparoscopic myomectomy preceded by temporary uterine blood supply occlusion or 2) laparoscopic myomectomy with a conventional approach. sixty patients will undergo laparoscopic myomectomy preceded by temporary uterine blood supply occlusion performed by gynecologists at mother and child clinic saint-petersburg and other institutions participating in the study. sixty patients will undergo conventional laparoscopic myomectomy performed by gynecologists at mother and child clinic saint-petersburg and other institutions participating in the study. patients eligible for inclusion, after signing an informed voluntary consent to participate in the study, will be randomized in a 1:1 ratio to the treatment groups using stratification by age, size, and leiomyoma nodes location.

Eligibility criteria:
inclusion criteria: * symptomatic uterine leiomyoma * size of leiomyoma node \>5 cm based on imaging * leiomyoma node types 3, 4, 5, 6 according to the international federation of gynecology and obstetrics (figo) classification or type 2 not feasible to be removed during hysteroscopy * single or multiple nodes * absent contraindications for laparoscopic myomectomy * voluntarily signed informed consent to participate in the study exclusion criteria: * age \< 18 years * asymptomatic uterine leiomyoma * size of leiomyoma node \<5 cm based on imaging * absence of leiomyoma node types 3, 4, 5, 6 according to figo classification and type 2 not feasible to be removed during hysteroscopy * planned simultaneous hysteroscopy with leiomyoma node excision * current pregnancy and breastfeeding * suspicion of a malignant uterine tumor * prior uterine leiomyoma surgery * contraindications for laparoscopic myomectomy * lack of decision-making capacity hindering signing the consent to participate in the study

Keywords: temporary uterine artery occlusion temporary uterine blood supply occlusion
prescribing interventions for chronic pain via the electronic health record study - opioid-naive population

Conditions: Opioid-use Disorder; Opioid Use; Opioid Abuse

Summary: the objective of this research is to assess the effects of electronic health record (ehr)-based decision support tools on primary care provider (pcp) decision-making around pain treatment and opioid prescribing. the decision support tools are informed by principles of "behavioral economics," whereby clinicians are "nudged," though never forced, towards guideline-concordant care.

to test the effects of these decision support tools for improving the quality of care for pain treatment, the investigators will implement a pragmatic clinic-randomized trial across the primary care clinics of fairview medical group and university of minnesota physicians. the study has two parallel components. the decision support tools to be tested will differ somewhat depending on whether a given patient is opioid-naïve, or whether a given patient is a current opioid-user. four sets of analyses will be conducted separately: one for the opioid-naïve group using ehr data, one for the current opioid-user group using ehr data, one at the pcp-level using web survey data, and one at the pcp-level using mn prescription drug monitoring program (pdmp) data.

Eligibility criteria:
inclusion criteria: - all primary care providers from all of the fairview and university of minnesota physicians study clinics exclusion criteria: - primary care providers who work less than 20% full time equivalent (fte)
efficacy study of folinic acid to improve mental development of children with down syndrome

Conditions: Down Syndrome

Summary: the purpose of this study is to determine whether folinic acid can improve developmental quotient of young down syndrome patients, given that these present signs of folate deficiency which are known to cause reversible neurological, psychiatric and cognitive disorders.


Eligibility criteria:
inclusion criteria: * down syndrome without mosaicism * age 3 to 30 months * weight over 4 kg * possible assessment by the revised brunet-lezine scale exclusion criteria: * history of leukemia * west syndrome or non-stable epilepsy * non-stable thyroxin treatment

Keywords: down syndrome folinic acid therapy cognitive functions
nintedanib and weekly docetaxel in lung adenocarcinoma

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: phase i study. to determine the mtd (maximum tolerated dose) of nintedanib + weekly docetaxel in patients with locally advanced or metastatic lung adenocarcinoma after failure of platinum-based first line chemotherapy.


Eligibility criteria:
inclusion criteria: -patients with histologically/ cytologically confirmed locally advanced (stage iiib) or metastatic (stage iv) lung adeno carcinoma after failure of first line platinum - based chemotherapy (patients with non-target lesion only are eligible). first line chemotherapy may include continuation or switch maintenance therapy. one prior adjuvant and/or neoadjuvant chemotherapy line is accepted. prior immunotherapy is allowed. * ecog inferior or equal to 1 at screening. * further inclusion criteria apply exclusion criteria: * patients who have received more than one prior line of chemotherapy (i.e. second or third line chemotherapy) for advanced or metastatic nsclc. * patients known to be positive for activating epidermal growth factor receptor (egfr) mutation or patients known to be positive for alk translocation * further exclusion criteria apply.
fnirs-based neurofeedback to reduce relapse in poud/aud

Conditions: Alcohol Use Disorder; Alcoholism; Prescription Drug Dependence; Opioid-use Disorder; Neurofeedback

Summary: this study will examine the impact of functional near-infrared spectroscopy-based neurofeedback to a region within the brain's prefrontal cortex involved with self-regulation of resisting craving in alcohol use and prescription opioid use disorder patients. participants will be asked to complete two cue reactivity tasks, six sessions of neurofeedback training as well as craving visual analog scales and self-efficacy questionnaires throughout a two-week period of their time in residential treatment at the caron treatment center. they will be followed for 90 days after treatment completion at caron to assess the impact neurofeedback had on their ability to remain sober once patients are living back in the "real world".


Eligibility criteria:
inclusion criteria: * sex: male or female * age: greater than or equal to 18 years * caron treatment center residential patients with alcohol use disorder, moderate to severe (equivalent to alcohol dependence in dsm-iv-tr), or prescription opioid use disorder (poud) * fluent in written and spoken english * patients who are right-handed * valid email address and reliable internet access after leaving the caron treatment center exclusion criteria: * patients who are concurrently receiving a psychoactive drug for the treatment of an axis i disorder. * patients with current major depressive disorder or schizophrenia, bipolar disorder, post-traumatic stress disorder, or a history of traumatic brain injury. * decisional impairment * adults unable to consent * women who are pregnant * prisoners * patients who are left-handed * no reliable email addresses

Keywords: prescription opioid use disorder alcohol use disorder functional near-infrared spectroscopy treatment outcome resisting craving