Kornimate/medical-research-clean huggingface dataset:
study to prevent negative thoughts of life

Conditions: Active Suicidal Ideations

Summary: the purpose of the study is to test whether cognitive behaviour therapy (cbt) offered by trained therapists, to people with current active suicidal ideations, is efficacious as a secondary prevention strategy in sri lanka, when compared with treatment as usual provided by medical officers (mental health; mo (mh)) of government hospitals


Eligibility criteria:
inclusion criteria: * age between 18 - 64 years * self reported current active suicidal ideations * ability to speak and write sinhala exclusion criteria: * an acute intent and planning of suicide * in-patient/out-patient treatment following an attempted suicide during the previous two-year period * a diagnosis of mental retardation * a diagnosis of sensory deficit * a diagnosis of alcohol abuse * a diagnosis of psychotic illness

Keywords: active suicidal ideation cognitive behavioural therapy sri lanka rct
integrating sex and gender into cpd for depression/diabetes

Conditions: Health Knowledge, Attitudes, Practice

Summary: people with type 2 diabetes are twice as likely to experience depression as nondiabetic individuals, and depression in turn increases the risk of diabetes. clinical care for patients for either condition usually fails to consider the impact of sex and gender on tests, diagnosis and treatment, and evidence on these impacts is limited. the investigators aim to assess the impact of a continuing professional education activity (cpd) on diabetes and depression that includes considerations of sex and gender on the clinical behaviours of french-speaking healthcare professionals in canada. in a non-randomised controlled trial, the investigators are assessing the impacts of two cpd activities on depression and diabetes, one that includes considerations of sex and gender, and an identical one that omits sex and gender considerations, on french-speaking healthcare professionals' self-reported clinical behaviors regarding sex and gender considerations post-intervention and at 3 months. data collection will occur in three distinct locations in canada. project development, data collection and analysis and dissemination of results will all integrate considerations of sex and gender. the process of creating a cpd activity that integrates considerations of sex and gender could be scaled up to other cpd activities in other clinical subjects and in other minority languages.


Eligibility criteria:
inclusion criteria: * french-speaking health professionals (in practice and in training).

Keywords: diabetes and depression continuing professional development continuing medical education sex and gender minority languages knowledge translation
study to explore the effective doses and to assess the safety and efficacy of hypidone hydrochloride tablets

Conditions: Major Depressive Disorder

Summary: the objective of this study is to evaluate the safety and efficacy of hypidone hydrochloride tablets in treatment of patients with major depressive disorder (mdd) by evaluating the change of madrs total scores from baseline to week 6.

a total of 240 major depressive disorder (mdd) subjects between the ages of 18-65 who have current major depressive disorder diagnosed by dsm-5 will be recruited, eligible patients will be randomized with a 1:1:1:1 ratio into the 4 treatment arms to receive either hypidone hydrochloride tablets or placebo, and will be accepted into the protocol after review and providing voluntary written informed consent forms and completion of a comprehensive medical and psychiatric history, physical examination, mental status examination, and routine laboratory assessment. the subjects will accept the drug treatment twice daily orally for 6 weeks. during the treatment follow up will occur at 8±1 days after treatment, 15±1 days after treatment, 29±2 days after treatment , 43±2 days after treatment to evaluate the safety and efficacy of the drug.

Eligibility criteria:
inclusion criteria: 1. outpatient or inpatient, 18-65 years old, male or female 2. current major depressive disorder diagnosed by dsm-5, single episode(296.21, 296.22, 296.23), or recurrent episode(296.31, 296.32, 296.33) 3. montgomery-åsberg depression rating scale (madrs) total scores in both screening and baseline ≥ 26 4. the first item of madrs in both screening and baseline ≥ 3 5. cgi-s in both screening and baseline ≥ 4 6. able to provide written informed consent forms exclusion criteria: 1. subjects accord with other mental disorders diagnosed by dsm-5 2. subjects who attempted to suicide, or who presently have a high risk of suicide, or with the tenth item (suicidal ideation) of c-ssrs ≥ 3 3. baseline total scores compared with the screening period, the reduction rate of madrs ≥ 25% 4. subjects with serious or uncontrolled cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease, respiratory disease 5. subjects with clinically significant ecg abnormal (male qtcf ≥ 450 msec, female qtcf ≥ 470 msec) 6. treatment with a maoi within the 2 weeks prior to the first dose of trial medication 7. practicing 2 different treatment methods of antidepressants as recommended dose of full course (≥6 weeks) 8. subjects who have had a vagus nerve stimulation (vns) device implanted, or who have received modified electric convulsive therapy (mect) or transcranial magnetic stimulation (tms) within 3 months of screening, or who received light treatment, laser treatment, acupuncture and other chinese medicine treatment, biofeedback treatment within 2 weeks of screening 9. subjects with a history of true allergic response to more than 1 class of medications 10. subjects who participated in a clinical trial within the last 30 days
an extension study assessing the efficacy and safety of brolucizumab in a treat-to-control regimen in patients with neovascular age-related macular degeneration who have completed the crth258a2303 (talon) study

Conditions: Neovascular Age-related Macular Degeneration

Summary: the purpose of this extension study was to evaluate the efficacy and safety of brolucizumab used in a treat-to-control-regimen for treatment of patients with neovascular age-related macular degeneration who have completed the crth258a2303 (talon) study. the main objective was to assess brolucizumab's potential for long durability up to 20 weeks. all eligible participants were treated with brolucizumab regardless of their treatment in the talon study. the study period was 56 weeks including post-treatment follow-up.

this was a 56-week, open-label, one-arm extension study in subjects who had completed the crth258a2303 (talon) (nct04005352) study, referred to as the core study in this document. subjects who provided written informed consent and met all the inclusion and none of the exclusion criteria were enrolled into this extension study to receive brolucizumab 6 mg in a treat-to-control (ttc) regimen, irrespective of the treatment received in the core study. the maximum study duration for a subject was 56 weeks, including post-treatment follow-up. there were two periods in this study: * treat-to-control treatment period: from baseline (day 1) to week 52 * post-treatment follow-up period: from week 52 to week 56. all participants were treated with brolucizumab regardless of their treatment in the talon study (brolucizumab or aflibercept). treatment intervals were then extended by 4 weeks at a time based on the investigator's judgment of visual and/or anatomic outcomes. the treatment intervals were to have been 4 weeks at a time if disease activity recurs.

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. successfully completed talon core study at week 64 (end of study) exclusion criteria: 1. medical condition or personal circumstance which precludes study participation or compliance with study procedures, as assessed by the investigator 2. discontinued study treatment in the core study 3. anti-vegf treatment is futile in the study eye, in the investigator's opinion. 4. pregnant or nursing (lactating) women 5. women of child-bearing potential not using highly effective methods of contraception

Keywords: neovascular age-related macular degeneration wet age-related macular degeneration wet amd choroidal neovascularization individualized treatment anti-vegf macular degeneration age-related macular degeneration (armd) vision loss macula damage retina damage dry macular degeneration wet macular degeneration subfoveal choroidal neovascularization (cnv) secondary to age-related macular degeneration
comparison of perioperative opioid consumption following pectoral nerve block for breast cancer surgery

Conditions: Nerve Block; Mastectomy

Summary: in this study, the investigators will compare the intraoperative opioid consumption for patients undergoing breast cancer surgery. the patients will be divided in two groups, the first one will receive a pectoral nerve block right after induction of anesthesia and the second one, the control group, will not receive the pectoral block. our hypothesis is that the pectoral nerve block reduces the opioid consumption during the surgery.

after induction of general anesthesia with propofol, remifentanil and succinylcholine, the patients will be divided either in the pectoral block group or the control group (sham block). both groups will receive the same perioperative and postoperative anesthetic protocol. the investigator in charge of the patient will leave the operative room right before the completion of the pectoral block (or the sham block) to preserve randomisation and the block will be performed by another investigator. the pectoral block is performed under ultrasound guidance with 10 cc of lidocaine 1% with epinephrine 1/400000 between the pectoralis major muscle and the pectoralis minor muscle and 20 cc of the same solution between the pectoralis minor muscle and the serratus anterior muscle at the third rib. anesthesia will be maintained with sevoflurane for a bispectral (bis) index between 45 and 60. analgesia will be provided with a perfusion of remifentanil adjusted to maintain a mean arterial blood pressure (map) in the range of ± 10% of the basal map (mean of the last three maps obtained before surgical incision, under sevoflurane-only anesthesia). the total remifentanil consumption will be assessed and compared between the groups. the investigators believe that the pectoral nerve block will significantly reduce the intraoperative remifentanil consumption.

Eligibility criteria:
inclusion criteria: * asa 1 to 3 inclusively * breast cancer surgery with or without axillary dissection exclusion criteria: * any contraindication to the pectoral nerve block (coagulopathy, infection, pre- existing neuropathy, local anesthetic allergy and refusal of local anesthesia) * refusal to participate in the study * patient with dementia * preoperative breast pain * preoperative opioid consumption * breast reconstructive surgery * bilateral surgery * pregnant patient

Keywords: analgesics, opioids pectoral block
ganglion cell thickness in enuresis nocturna

Conditions: Enuresis, Nocturnal; Ganglion; Circadian Rhythm Disorders

Summary: the precise role of the intrinsic circadian regulatory mechanism behind the pathogenesis of enuresis is not fully understood, but in theory, circadian rhythm irregularity may be the primary pathogenic mechanism not only for urinary outflow mechanisms but also for nocturnal bladder function. the proximity between scn centers that control avp release, sleep/arousal, voiding, and baroreregulation may provide the basis for circadian rhythm disturbance in one or more of these biological functions. ganglion cells containing melanopsin pigment in the retina transmit the information they receive from the outside world about the light-dark state to the scn via the retinohypothalamic pathway. peripapillary retinal nerve fiber layer (rnfl) thickness, optic nerve head and macula are examined most frequently for the diagnosis of glaucoma and the detection of progression with optical coherence tomography (oct). if differences in ganglion cell thickness can be detected using oct in these children, a new avenue in enuresis nocturna may be opened.


Eligibility criteria:
inclusion criteria: * be between the ages of 5-18 * have enuresis exclusion criteria: * have any eye conditions

Keywords: enuresis optical coherence tomography
blood loss at the time of first trimester surgical abortion in anticoagulated women

Conditions: Blood Loss

Summary: the primary objective of this study is to compare blood loss resulting from surgical termination of pregnancy up to 12 weeks gestation between women who are anticoagulated to therapeutic levels and those who are not anticoagulated. this study is based on the hypothesis that anticoagulant therapy does not increase intraoperative blood loss in women receiving surgical abortions up to 12 weeks gestation.

we intend to conduct a prospective cohort study at oregon health and science university and the university of hawaii. this study will not be blinded and subjects will not be randomized. women will be approached about this study after they have made a decision to terminate the pregnancy and have completed the preoperative history and physical examination and surgical consenting process. for patients who are receiving anticoagulant medications, the decision to continue anticoagulant therapy or interrupt it will be made by the patient's physician, independently of this study. we will recruit women who continue on anticoagulant therapy (heparin, low molecular weight heparin, or warfarin) without interruption for the surgical procedure. our control group will consist of women who are not on anticoagulant treatment. this is a matched study and our control group will be matched for gestational age, parity, and cesarean section history.

Eligibility criteria:
inclusion criteria: * female seeking abortion services * less than or equal to 12 weeks gestation * age 18-50 * willing and able to sign informed consent * use of coumadin or lmw heparin (treatment group only) exclusion criteria: * unwilling or unable to sign informed consent * women taking daily aspirin or herbal therapies containing gingko biloba * women with a known history of a bleeding disorder such as von willebrand's disease

Keywords: anticoagulation surgical abortion
immune response in peripheral blood of patients with colon cancer

Conditions: Colorectal Cancer

Summary: rationale: studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in the immune system that may help kill cancer cells. purpose: this laboratory study is looking at anticancer immune responses in the peripheral blood of patients with colon cancer.

objectives: * quantify t cells specific for tumor peptides (carcinoembryonic antigen and muc1) from the peripheral blood of patients with colon cancer. outline: this is an open-label study. patients undergo blood collection at time of follow-up, surgery, thoracentesis, paracentesis, or leukapheresis (≤ 5 times per year). blood is analyzed for tumor peptides (carcinoembryonic antigen and muc1), circulating cytokines, and lymphocyte response by elisa, elispot, or intracellular flow. projected accrual: a total of 140 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of colon cancer patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: recurrent colon cancer stage i colon cancer stage ii colon cancer stage iii colon cancer stage iv colon cancer
aliskiren or losartan effects on biomarkers of myocardial remodeling

Conditions: Hypertension; Left Ventricle Hypertrophy

Summary: the purpose of this study is to assess efficacy of aliskiren for reducing circulating levels of biomarkers of left ventricular (lv) remodeling associated with lv hypertrophy (lvh) in hypertensive patients.

blood pressure was measured 10 weeks after starting treatment (visit 3). all patients who did not achieve the required blood pressure (\<140/90 mmhg) after 8 weeks of treatment at the maximum doses of study medication were given 5 mg of amlodipine in addition to the study medication in order to reach the required bp (\<140/90 mmhg). the patient's blood pressure was assessed at visit 4 (week 18) and if it was still not at the required level (\<140/90 mmhg), the dose of amlodipine was increased to 10 mg. blood pressure was again assessed at visit 5 (week 26) and if the required values had not been reached (\<140/90 mmhg), a 12.5 mg dose of hydrochlorothiazide (hctz) was prescribed

Eligibility criteria:
inclusion criteria: * patient with hypertension * confirmed concentric left ventricular hypertrophy: * lvmi \> 49.2 g/m2.7 for men and \>46.7 g/m2.7 for women * relative wall thickness \> 0.42 exclusion criteria: * sever or secondary htn * lv ejection fraction of \<40% * patient with compelling indication to aceis or arbs or bb * history of myocardial infarction, coronary artery bypass surgery, ptc intervention, tia or stroke within 6 months of study entry * history of collagenopathies, osteopathy * egfr \<30 ml/min/1,73 m2, serum potassium ≥5,2 meq/l * morbid obesity (bmi ≥ 42 kg/m2 * other protocol-defined inclusion/exclusion criteria may apply

Keywords: aliskiren hypertension concentric lvh lv remodeling lvmi biomarkers picp ct-1 mmp-1 timp-1 anxa5 aldosterone essential hypertension with concentric left ventricle hypertrophy
i̇ntraoperative awareness under general anesthesia

Conditions: To Investigate the Incidence and Causes of Awareness During General Anesthesia; To Investigate the of Dreaming During Anesthesia; To Investigate the Intra-operative Experiences of Patients Who Report Awareness; To Investigate the Risk Factors That May be Associated With Awareness; To Analyze the Frequency of Posttraumatic Stress Disorder in Cases With Awareness and Possible Awareness; To Investigate the Risk Factors That May be Associated With Posttraumatic Stress Disorder

Summary: intraoperative awareness which means the recall of experiences recorded in patients' memories during general anesthesia in the postoperative period is an important issue in anesthesia practice. the aims of this study are to investigate the incidence and causes of awareness during general anesthesia, incidence of dreaming during anesthesia, intra-operative experiences of patients who report awareness, the risk factors that may be associated with awareness, to analyze the frequency of posttraumatic stress disorder in cases with awareness and possible awareness, the risk factors that may be associated with ptsd in turkish adults. adult patients will be evaluated 4 time following emergence (a) one hour after emergence, (b) twenty four hour after emergence (c) one week after emergence (d) one month after emergence. the first interview will be made face-to-face in the recovery unit, and other interviews will be made by phone. each interview will be conducted using the same structured interview (brice interview). descriptive statistics will be used to determine the incidence of awareness. χ2 test will be used for comparison between groups. logistic regression will be used to determine the risk factors associated with awareness and ptsd. we believe that this study will contribute to the prevention of the problem by determining the real frequency and causes of intraoperative awareness under general anesthesia, determining the experiences and results of patients, and analyzing the associated risk factors.


Eligibility criteria:
inclusion criteria: * asa i-iv adult patients who will receive general anesthesia and are scheduled to be extubated postoperatively, exclusion criteria: * asa v patients * patients below 18 years of age, * patient who can not give informed consent, * patients who have known psychological or psychiatric problems, * patients who are not suitable for postoperative follow-up

Keywords: intraoperative awareness general anesthesia dreaming incidence
triglyceride-glucose index in diabetic nephropathy in type 2diaberes mellitus patients

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of the present study is to investigate the associations between the tyg index and diabetic nephropathy in patients with type2 dm .

the triglyceride-glucose (tyg) index was proposed as a simple and reliable surrogate marker of ir, and it has been reported to be closely correlated with the homa-ir index. the tyg index has the advantage of being applicable in clinical practice since both triglyceride and glucose levels are routinely measured and the cost of these measurements is low.

Eligibility criteria:
inclusion criteria: * patients with type 2 dm exclusion criteria: - (1) individuals with obstructive uropathy, severe heart failure, stroke, liver disease, cancer, autoimmune disease (2) pregnant woman. (3)end stage renal disease patients on dialysis ( glomerular filtration rate \<15 ml/min/1.73 m2) or renal transplantation. (4) type 1 diabetic patient. (5) albuminuria due to non-diabetic renal disease
effects of sitaxsentan on proteinuria, 24-hour blood pressure, and arterial stiffness in chronic kidney disease subjects

Conditions: Chronic Kidney Disease

Summary: this study is being conducted to evaluate sitaxsentan dosing in subjects with chronic kidney disease.


Eligibility criteria:
inclusion criteria: * has stage 1-5 chronic kidney disease (ckd) as defined by the kidney disease outcomes quality initiative (k/doqi) with proteinuria, including any of the following aetiologies: immunoglobulin (iga) nephropathy, polycystic kidney disease (pckd), congenital abnormalities, reflux nephropathy, focal segmental glomerulosclerosis, minimal change nephropathy, and membranous nephropathy. exclusion criteria: * required peritoneal dialysis or haemodialysis. * has kidney disease due to diabetes mellitus, vasculitis, systemic lupus erythematosus, or known renovascular disease; antiglomerular basement membrane disease; or is on immunosuppressive medication.

Keywords: chronic kidney disease sitaxsentan
disease stabilization in aml by treatment with atra, valproic acid and low-dose cytarabine

Conditions: Acute Myelogenous Leukemia

Summary: hypothesis: combined treatment with valproic acid and atra can be used to achieve disease stabilization for a subset of patients with acute myelogenous leukemia (aml), and this effect can be improved without serious toxicity by adding low-dose cytarabine to this treatment. adult patients \>18 years of age who can be included: elderly patients who cannot achieve standard chemotherapy, patients with relapsed or resistant aml. treatment: combined therapy with: valproic acid, continuous therapy until disease progression atra, oral therapy for 14 days every three months low-dose cytarabine 10 mg/m2 up to 10 injections during week 2 and 3, repeated every 3 months.

patients to be included: 1. elderly patients (\>60 years of age) or other patients unfit for conventional intensive chemotherapy with newly diagnosed acute myelogenous leukemia (aml). 2. adult patients of any age (\>18 years of age) with relapsed or resistant aml who cannot receive conventional therapy. treatment: valproic acid to be started on day 1 as continuous therapy until disease progression. atra administered from day 8 orally as 22.5 mg/m2 twice daily for 14 days, repeated every third month. low-dose cytarabine 10 mg/m2 from day 14 and continued as daily injections for up to 10 days, repeated every third month. supportive therapy is given according to the hospitals general guidelines. followup: the first 2 days treatment in hospital, later regular out-patient treatment. controls will include clinical examination, peripheral blood parameters (including serum valproic acid levels), bone marrow samples.

Eligibility criteria:
inclusion criteria: * recently diagnosed aml in patients unfit for intensive chemotherapy * patients with relapsed or refractory aml exclusion criteria: * no informed consent * intolerance to study drugs * serious liver disease

Keywords: acute myelogenous leukemia all-trans retinoic acid valproic acid cytarabine disease stabilization survival toxicity