Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of nbi-98854 in subjects with tardive dyskinesia

Conditions: Tardive Dyskinesia

Summary: the purpose of this study is to assess the safety and efficacy of three doses (12.5, 25, and 50 mg) of nbi-98854 for the treatment of the symptoms of tardive dyskinesia (td) in subjects with schizophrenia or schizoaffective disorder.

this is a phase 2, open-label, dose titration study to assess the efficacy and safety of three once daily (q.d.) doses (12.5, 25, and 50 mg) of nbi-98854 administered once daily for up to 12 days consisting of three treatment periods of 4 days each (periods 1, 2, and 3). the starting dose will be 12.5 mg q.d. (period 1), and this dose will be escalated to 25 mg q.d. (period 2) and then to 50 mg q.d. (period 3) based upon each subject's ability to tolerate nbi-98854. progression to the next dose level will be based upon the subject's ability to tolerate the previous dose and the investigator's review of adverse events and safety data. for subjects who do not tolerate a dose increase, the dose may be decreased to the dose that was previously administered (i.e., 25 mg to 12.5 mg, 50 mg to 25 mg) and continued at that dose for the remainder of the study treatment. up to 10 medically stable subjects with schizophrenia or schizoaffective disorder who have moderate or severe symptoms of td will be enrolled as outpatients.

Eligibility criteria:
inclusion criteria: * males or females (non-childbearing potential) aged 18 to 65 years (both inclusive). * have moderate or severe tardive dyskinesia symptoms (total aims score of at least 9) * have a clinical diagnosis of schizophrenia or schizoaffective disorder. * receiving a stable dose of antipsychotic medication for a minimum of 30 days or have stable psychiatric status. * doses of concurrent medications and the conditions being treated have been stable for a minimum of 30 days and expected to remain stable during the study. * are in good general health and expected to complete the clinical study as designed. * have a body mass index (bmi) of 18 to 38 kg/m\^2. * have adequate hearing, vision, and language skills to perform the procedures specified in the protocol. exclusion criteria: * have an active clinically significant unstable medical condition within 1 month (30 days) prior to screening. * have a history of substance dependence or substance (drug) or alcohol abuse within the 3 months before study start. * have a known history of neuroleptic malignant syndrome. * have a significant risk of suicidal or violent behavior. * receiving medication for the treatment of tardive dyskinesia * receiving any excluded concomitant medication as specified in the protocol.
oral alfacalcidol and coronary artery calcification in predialysis chronic kidney disease

Conditions: Vascular Calcification

Summary: active vitamin d at therapeutic dose may prevent vascular calcification but in supraphysiologic dose may precipitate it.

active vitamin d compound is used frequently in the treatment of hyperparathyroidism in chronic kidney disease. recent evidence from animal studies suggested that low dose of active vitamin d may be protective against vascular calcification, whereas high dose could precipitate it. the present study will examine the effect of low dose oral alfacalcidol on coronary artery calcification in predialysis chronic kidney disease patients with hyperparathyroidism.

Eligibility criteria:
inclusion criteria: * predialysis chronic kidney disease with gfr \< 90 ml/min/1.73m2 * pth above the upper limit of normal * serum calcium and phosphate below the upper limit of normal exclusion criteria: * changes in gfr\>15% during the past 3 months * receive elemental calcium\>500 mg/day * currently taking active vitamin d, oral calcium with elemental calcium\>500 mg/day or bisphosphonate

Keywords: coronary calcification vascular calcification active vitamin d alfacalcidol
genomic dissection of a qtl affecting the lipid profile

Conditions: Cardiovascular Diseases; Heart Diseases; Obesity; Hyperlipidemia, Familial Combined

Summary: to search for the genetic cause of the metabolic syndrome, a lipid disorder that poses a major risk for coronary heart disease.

background: the metabolic syndrome is a common disorder posing a significant major risk for coronary heart disease and early mortality in the western hemisphere. central to its cardiovascular complications is the association of the syndrome with the specific abnormalities in plasma lipid and lipoprotein profiles including increased plasma triglycerides, decreased hdl cholesterol, and predominance of dense lipoprotein particles. in search for the genetic etiology of this lipid disorder, the investigators identified a quantitative trait locus (qtl) on human chromosome 7q36 strongly linked to variation in plasma lipid levels. they hypothesize that this qtl contains genetic variants that contribute to alterations in biologic pathways underlying the genesis of the lipid disorder. design narrative: the study will search for the genetic cause of the metabolic syndrome, a lipid disorder that poses a major risk for coronary heart disease. the investigators have identified a quantitative trait locus (qtl) on human chromosome 7q36 strongly linked to variation in plasma lipid levels. the investigators hypothesize that this qtl contains genetic variants that contribute to alterations in biologic pathways underlying the genesis of the lipid disorder. to test for this hypothesis, they propose a comprehensive approach utilizing established resources and expertise to identify the functional sequence variants within this qtl. specifically, they will 1.) identify single nucleotide polymorphisms (snps) and their haplotype and linkage disequilibrium structure across the entire qtl region; 2.) analyze association of informative snps with plasma triglyceride levels, ldl levels, and lipoprotein density fractions using variance component linkage/disequilibrium analyses; and 3.) identify potentially functional sequence variants in associated genes or genomic regions using bayesian quantitative trait nucleotide analysis. this comprehensive application of newly available genomic technologies, novel statistical approaches, the dna and phenotypic information available, and the consortium of expertise assembled behind this project will ensure the successful elucidation of the genetic etiology of this lipid disorder and consequently the development of effective means for prevention and/or treatment of cardiovascular complications of the metabolic syndrome.

Eligibility criteria:
no eligibility criteria
mobile health technology-enabled afib management

Conditions: Atrial Fibrillation; Behavior

Summary: the overall objective of this proposal is to evaluate the effect on quality of life of a comprehensive digital atrial fibrillation (afib) management tool that will empower patients to a) take an active role in learning about afib management options, starting and adhering to evidence-based therapies and lifestyle changes and b) to guide the patients during afib episodes which are associated with anxiety and impairment in quality of life. researchers plan to evaluate the effectiveness of this novel digital toolkit in improving quality of life and decreasing afib burden in a randomized clinical trial (rct). a pilot study assessing feasibility and retention of the intervention was previously conducted (nct05400837)


Eligibility criteria:
inclusion criteria: 1. aged 18 or older at time of consent 2. diagnosis of paroxysmal (afib lasting less than 7 days) or persistent (7 days or longer) atrial fibrillation 3. bmi (body mass index) ≥ 27.0 exclusion criteria: 1. permanent afib (decision has been made not to attempt sinus rhythm) 2. severe valvular disease 3. moderate mitral valve stenosis 4. prior cardiac surgery 5. presence of implanted cardiac device 6. history of cardiac arrest 7. left ventricular ejection fraction (lvef) ≤ 35% 8. life expectancy \< 1 year 9. non-english speaking 10. treating clinician deems unsafe for exercise 11. any other reason that makes patient unsuitable for study at the discretion of the pi

Keywords: remote patient monitoring atrial fibrillation risk factor modification digital health mobile health
olfactory and visual perception in depressed patients

Conditions: Depression

Summary: the study aimed to determine the emotional reactivity of depressed patients to visual and olfactory stimuli in comparison with healthy volunteers.


Eligibility criteria:
inclusion criteria: * no cognitive impairment that could prevent instruction comprehension * no more than 10 cigarettes/day * signed informed consent * group 1: current major depressive disorder * group 2: no current major depressive disorder exclusion criteria: * pregnancy * visual impairment * olfactory impairment

Keywords: depression emotional reactivity
subcutaneous bupivacaine decrease post-op pain in patients undergoing c-section

Conditions: Pain, Referred

Summary: the purpose of this study is to determine if giving an injection of numbing medication at the incision at the end of cesarean will help control pain after cesarean delivery. this study seeks to assess pain relief with incisional infiltration of local anesthetic during cesareans performed under spinal anesthesia also using intrathecal opioids. participants will receive the usual regimen of pain medication in spinal anesthesia. at the end of the cesarean delivery, while the participants are still under the spinal medication, participants will receive an injection, at the incision, either numbing medication (with or without epinephrine) or sterile saline. after the cesarean delivery, participants will receive, by mouth, commonly prescribed pain medications - these medications are oxycodone (an opioid/ narcotic), acetaminophen (or more commonly known as tylenol), and ibuprofen.

the study assesses addition of subcutaneous bupivacaine with and without epinephrine to the standard intrathecal morphine/fentanyl combination given during spinal anesthesia during elective cesarean delivery on postoperative pain control as measured by postoperative usage of oral opioids and a postoperative pain assessment scale. comparing post-op pain scores and oxycodone usage in patients who receive just intrathecal morphine to patients who receive intrathecal morphine plus subcutaneous bupivacaine .25%, to patients who receive bupivacaine .25% with epinephrine 1:200,000. after cesarean delivery, all groups will actively control the use of post-operative pain medication by indicating to the care nurse whether or not pain medication is desired. pain control for all groups will be the standard pain treatment: ibuprofen for mild to moderate pain and percocet (oxycodone) for severe pain. the u.s. food and drug administration (fda) has approved bupivicaine as an anesthetic and for pain but the fda has not approved bupivicaine to be given specifically for postoperative cesarean pain. acetaminophen, oxycodone and ibuprofen are being used as part of routine clinical care for pain control after cesarean. fentanyl and duramorph are being used in spinal anesthesia and are fda approved for regional anesthesia and used for this purpose in routine clinical care.

Eligibility criteria:
inclusion criteria: * elective cesarean delivery * planned spinal anesthesia exclusion criteria: * non-english speaking * urgent or emergent cesarean delivery * active labor \[defined as: \>4cm cervical dilation or regular contractions noted on tocometer (\>2 contractions in a 10 minute period for 30 consecutive minutes)\] * chronic antepartum opioid use * history of substance abuse (alcohol or drug) * current tobacco use * chronic steroid use
parasternal block for cardiac surgery

Conditions: Cardiac Disease; Analgesia; Acute Pain; Postoperative Pain

Summary: this study examine the effect of parasternal intercostal nerve blocks with local anesthetic on pain control in patients undergoing non-emergent cardiac surgery in a prospective controlled trial. half of participants will receive general anesthesia combined to parasternal block while the other half receive only general anesthesia.

60 patients undergoing elective cardiac surgery will be enrolled and divided into two groups: 1. interventional (parasternal group) 2. case control group the "parasternal group" of patients will receive the pre-operative parasternal block (20 ml of 0.5% ropivacaine per side) in association with infiltration with local anesthetic of access to thoracic drainage (drainage infiltration with 20 ml of 0.25% ropivacaine) at the end of the intervention combined to general anesthesia. the "case control group" will only receive drainage infiltration with local anesthetic and standard intraoperative management with opioids.

Eligibility criteria:
inclusion criteria: * patients undergoing elective cardiac surgery * age over 18 years * asa i-iv * approval by the patient of informed consent exclusion criteria: * allergy to local anesthetics * puncture site infection * lack of signing of informed consent * weight \<30 kg * age \<18 years * emergency interventions * asa \> iv * sternal dehiscences * dementia (for difficulties in managing weaning from mechanical ventilation and pain)
resminostat (yhi-1001) in combination with sorafenib in asian patients with advanced hepatocellular carcinoma (hcc)

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to assess efficacy and safety in combination of resminostat and sorafenib in asian patients with advanced hcc previously untreated with systemic chemotherapy.


Eligibility criteria:
main inclusion criteria: * patients with advanced or metastatic hepatocellular carcinoma * patients with ecog ps of 0-1 * patients who can be treated with oral medications and have no gastrointestinal function disorder which is considered to affect the absorption of medications main exclusion criteria: * patients with a history of treatment with hdac inhibitors * pregnant women and lactating mothers * patients with brain metastases or suspected brain metastases based on the clinical symptoms
epidemiological investigation of sepsis in obstetrics admitted to icu

Conditions: Maternal Sepsis; Intensive Care Units; Drug Resistance, Multiple

Summary: sepsis is still the main cause of maternal death, accounting for 11% of maternal deaths. early identification of high risk factors of sepsis and early intervention can improve the prognosis of pregnant women with sepsis. at present, there is no epidemiological investigation report on sepsis in icu in china.

although great progress has been made in maternal care in china in recent years, the maternal mortality rate in china has remained high in the past three years, fluctuating from 19.6-20.1/100000, and there is still a large gap between china and developed countries (12.1/100000). sepsis is still the main cause of maternal death, accounting for 11% of maternal deaths; early identification of high risk factors of sepsis and early intervention can improve the prognosis of pregnant women with sepsis. at present, there is no epidemiological investigation report on sepsis in icu in china. a total of 160 cases of maternal sepsis with icu admission in any trimester of pregnancy or within 42 days of delivery were reviewed between january 1, 2008, and december 31, 2019. the demographic data including age and gestational age, mode of delivery, the maximal sofa score, invasive operation before sepsis, sepsis focuses, intervention, microbial culture results, body temperature and blood routine were reviewed to investigate the incidence and mortality of maternal sepsis in intensive care unit, as well as the incidence of multidrug-resistant bacteria and the risk factors of multidrug resistance.

Eligibility criteria:
inclusion criteria: obstetrics with sepsis in any trimester of pregnancy or within 42 days of delivery - exclusion criteria: the electronic medical record is lost. patients with incomplete infection data: if the temperature sheet is ambiguous and the temperature data is not recorded in the medical record. -
a multi-center observational surveillance study of vap causing bacteria

Conditions: Ventilator Associated Pneumonia

Summary: detect the clinical causitive pathogen of ventilator associated pneumonia (vap) patients by the bronchoalveolar lavage (bal) method.

any patient admitted into the chosen icu will be a potential patient for this study. one of the main purposes of this study is to discover the various types of bacteria that cause vap, and their frequency of occurrence. in order to obtain accurate and applicable results, as many subjects should be tested as possible. approximately 500 patients will be included in this study. vap is defined as any lower respiratory tract infection that developed after 2 day of mv. the criteria for clinical suspicion of pneumonia are as follows: presence of a new or persistent lung opacity on chest radiographs, plus two of the following items: 1. fever \> 38.3ºc or hypothermia \< 36ºc; 2. wbc count \> 10,000/mm3 or \< 5,000/mm3, and/or purulent endoctracheal aspirate; 3. purulent endotracheal aspirate. every patient suspected of having pneumonia will undergo fiberoptic bronchoscopy to obtain samples by means of a bronchoalveolar lavage (bal). vap will be diagnosed based on results of bal where bal cultures yielding \> 104 cfu/ml.

Eligibility criteria:
inclusion: * patients hospitalized and mechanically ventilated for more than 48 hours are eligible for the study. * fever \> 38.3ºc or hypothermia \ 10,000/mm3. * presence of a new or persistent lung opacity on chest radiographs. * willing to provide informed legal consent. if the patient is a minor or incapacitated, legal consent may be given by a legal guardian or representative. exclustion: * patients whose antibiotic strategy had been changed during the 3 days preceding the diagnostic procedure will not be included.

Keywords: vap
safety and efficacy of repeated intravitreal administration of vascular endothelial growth factor (vegf) trap in patients with wet age-related macular degeneration (amd)

Conditions: Macular Degeneration

Summary: this study examines the effect of intravitreally administered vegf trap in patients with wet amd. the purpose of this trial is to assess the ocular and systemic safety and tolerability of repeated intravitreal doses of vegf trap in patients with subfoveal choroidal neovascularization (cnv) due to amd.

this is a double masked, prospective, randomized study in which five groups of approximately 30 patients meeting the eligibility criteria will be randomly assigned in a balanced ratio to receive a series of intravitreal (ivt) injections of vegf trap into the study eye at 4- or 12 -week intervals over a 12-week period. after week 12, patients will be evaluated every 4 weeks. patients will remain on study or may be eligible to enter a long-term extension study, in which they will continue to receive vegf trap.

Eligibility criteria:
inclusion criteria: * subfoveal cnv secondary to amd. * central retinal (including lesion) thickness ≥ 300 µm as measured by optical coherence tomography (oct). * early treatment of diabetic retinopathy study (etdrs) best-corrected visual acuity of 73 letters to 34 letters. exclusion criteria: * history of any vitreous hemorrhage within 4 weeks prior to day 1. * aphakia. * significant subfoveal atrophy or scarring. * prior treatment with the following in the study eye: * subfoveal thermal laser therapy. * submacular surgery or other surgical intervention for the treatment of amd. * extrafoveal laser coagulation treatment within 12 weeks prior to day 1. * photodynamic therapy (pdt) within 12 weeks prior to visit 2 (day 1). * pegaptanib sodium (macugen) within 8 weeks of visit 2 (day 1). * juxtascleral steroids or anecortave acetate within 24 weeks (6 months) prior to visit 2 (day 1). * intravitreal administration of triamcinolone acetonide or other steroids within 24 weeks prior to visit 2 (day 1), unless no visible residue of drug substance can be seen in the vitreous cavity using indirect ophthalmoscopy. * prior systemic or intravitreal treatment with vegf trap, ranibizumab (lucentis) or bevacizumab (avastin). * presence of any other condition or laboratory abnormality, which, in the opinion of the investigator, would interfere with the assessment of disease status/progression or jeopardize the patient's appropriate participation in this phase ii study.

Keywords: neovascular age-related macular degeneration
campto-cisplatine plus radiotherapy in advanced cervix cancer : search of tolerated maximum dose of campto

Conditions: Cervix Cancer

Summary: search of maximum tolerated irinotecan dose in association with cisplatin and pelvic radiotherapy in patients with an advanced cervix cancer.

to determine the maximum and the recommended tolerated dose of irinotecan with increasing doses associated with weekly cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer, iib-iva figo stage.

Eligibility criteria:
inclusion criteria: * histologically proven primitive epidermoid or andenocarcinoma cervix * figo stage iib (obviously parameter attack), iii or iva * no previous chemotherapy nor radiotherapy * patient for whom a radiochemotherapy is envisaged as first intention treatmentof her cervix carcinoma * ps ecog \< 2 * life expectancy \> 12 weeks * written consent given exclusion criteria: * other malignant cervix tumor histology * visceral remotly metastasis * other malignant tumor since 5 years, except spino or baso-cellular treaten and cured cancer * anormal labs values * peripheric neuropathy ctc \> 2 * auditory loss \> 2 * cardiopathy * inflammatory digestive pathology * evolutive infection * other experimental concommitant treatment * lacting or pregnant women

Keywords: cervix cancer advanced cervix cancer radiochemotherapy pelvic radiotherapy campto cisplatin irinotecan cisplatyl maximum dose search
does social media impact adolescent mental health?

Conditions: Mental Health

Summary: the mental health of adolescents in the united states has seen a steep decline since 2011, roughly coinciding with the increasing popularity of social media and smartphones. but does social media have a causal impact on the mental health of adolescents or are concerns about the effect of social media on kids a form of public hysteria? in this study, the investigators will conduct the first field experiment in 11-14-year-olds to examine whether, how, and for whom social media harms mental health.


Eligibility criteria:
inclusion criteria: 1. is an adolescent who is between the ages of 10 and 14; 2. is an adolescent whose parents have decided to buy them their first smartphone; 3. is an adolescent both of whose parents/guardians consent for them to be in the study; 4. is an adolescent who assents to be in the study; 5) is an adolescent who speaks and reads english sufficiently to complete surveys and provide informed consent. exclusion criteria: 1. is an adolescent who has severe developmental problems (e.g., autism, severe language delay); 2. is an adolescent who is currently or has ever been diagnosed with severe or moderately severe mental illness; 3. is an adolescent who is currently or has ever experienced suicidal ideation.

Keywords: social media mental health depression anxiety