Kornimate/medical-research-clean huggingface dataset:
a study of bi-level positive airway pressure (bipap) versus non invasive positive pressure ventilation (nippv) for neonatal respiratory failure

Conditions: Neonatal Respiratory Failure

Summary: to research the effect of bi-level positive airway pressure (bipap) for neonatal respiratory failure.

bi-level positive airway pressure(bipap) is similar to non invasive positive pressure ventilation (nippv), but also gives some breaths, or extra support, to newborn infants through a small tube in the nose. bipap is safe and effective. nevertheless, bipap has never been used in chinese babies.

Eligibility criteria:
inclusion criteria: 1. newborn infants with birth weight \> 500 gm. 2. gestational age \> 24 completed weeks. 3. intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either: the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support. 4. no known lethal congenital anomaly or genetic syndromes. 5. signed parental informed consent. exclusion criteria: 1. considered non-viable by clinician (decision not to administer effective therapies) 2. life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis) 3. infants known to require surgical treatment 4. abnormalities of the upper and lower airways 5. neuromuscular disorders 6. infants who are \> 28 days old and continue to require mechanical ventilation with an endotracheal tube

Keywords: neonatal respiratory failure newborn infant bipap nippv
survival and neonatal outcomes of very low birth weight infants in türkiye: turkish neonatal society secrets-tr study

Conditions: Morbidity;Infant

Summary: the aim of this multi-center study was to evaluate the mortality rate and early neonatal outcomes of very low birth weight (vlbw) infants hospitalized in neonatal intensive care units (nicus) in türkiye. it was promoted by the turkish neonatology society (tns) and research was approved by the cam and sakura city hospital ethical committee. it was conducted between 28 april 2021 and 02 january 2023 and written informed consents from the families of included patients were obtained. a total of 74 level iii and iv nicus participated to the study. all the centers had an oppurtunity to follow-up these high risk premature infants in terms of their medical staff, equipment and other neonatology sources. the inclusion criteria consisted of preterm infants with birth weight (bw)≤1500 grams and with gestational age (ga) of 24 0/7 weeks to 31 6/7 weeks, all inborn and outborn infants admitted to nicu within the first 24 hours of life and approval of parental consent.the survival status, maternal, perinatal and neonatal characteristics, risk factors and early neonatal outcomes of all infants were recorded.

the study includes the selected cohort of approximately 3000 very low birth weight preterm infants born in one year period in turkey in level iii/iv neonatal intensive care units (nicus). detailed information on antenatal (growth, infection), natal (neonatal resuscitation, non-invasive/invasive ventilation and surfactant administration in the delivery room) and postnatal clinical course in nicus (ventilatory support, circulation, intestinal and cranial event status,growth, exitus) were recorded. the mortality and overall spesific morbidities of the study population will be evaluated. also, subgroup analysis for extremely low birth weight infants, micropremies, gray zone infants (22 to 24 weeks of gestational age) will also be performed for local data of turkey and will be used for development of local guidelines and improvements in the care of preterm infants.

Eligibility criteria:
inclusion criteria: * preterm infants with bw≤1500 grams and with gestational age (ga) of 24 0/7 weeks to 31 6/7 weeks, * all inborn and outborn infants admitted to nicu within the first 24 hours of life * presence of parental consent exclusion criteria: * the larger infants than inclusion criteria, * infants who died in the delivery room, * infants admitted to nicu after first 24 hours of life, * infants with major congenital/chromosomal abnormalities * refusal of parental consent

Keywords: prematurity, very low birth weight infant outcomes mortality morbidity
an efficacy and safety trial of intravenous zoledronic acid in infants less than one year of age, with severe osteogenesis imperfecta

Conditions: Osteogenesis Imperfecta

Summary: the investigators have currently finished conducting an international multi-center trial that compares the efficacy and safety of pamidronate and zoledronate in the treatment of moderate to severe forms of osteogenesis imperfecta (oi). this trial has included only children above one year of age. the aim of the current study is to extend the observations of that currently finished study to infants below 1 year of age. moreover, it is possible to administer zoledronate in a single short infusion instead of the three-day cycles with pamidronate, therefore decreasing patient and family burdens with shorter stays in the hospital.


Eligibility criteria:
inclusion criteria: * children, male or female 2 weeks to \< 12 months of age, at least at 38 weeks gestational age. * any child with phenotypic oi type ii, iii or iv. * any child classified as oi type i, v-viii that has had at least two or more previous fractures of long bone, or vertebral compression fractures, and a low bone mineral density. * no previous treatment with bisphosphonates. * negative urine protein as measured by dipstick. one repeat assessment of the urine protein will be allowed. exclusion criteria: * blood oxygen saturation of less than 90% in room air. * serum creatinine level greater than 56 µmol/l. * any clinically significant clinical laboratory abnormalities at screening. * treatment with any investigational drug within the past 30 days. * patients who are unlikely to be able to complete the study or comply with the visit schedule. * any disease or planned therapy which will interfere with the procedures or data collection of this trial.

Keywords: osteogenesis imperfecta infants with moderate to severe osteogenesis imperfecta
a trial evaluating tg4050 in ovarian carcinoma.

Conditions: Ovarian Carcinoma; Fallopian Tube Cancer; Peritoneal Carcinoma

Summary: this is a multicenter, open-label, single arm phase i study evaluating the safety and tolerability as well as some activity parameters of tg4050 in patients with ovarian, fallopian or peritoneal serous carcinoma.


Eligibility criteria:
inclusion criteria: 1. signed written informed consent. 2. female patients ≥ 18 years 3. histologically confirmed high grade, advanced stage serous ovarian, fallopian tube or primary peritoneal carcinoma. 4. patients who have undergone primary debulking surgery or interval debulking surgery and have completed standard first-line platinum-based chemotherapy and for whom tumor tissue has been banked. 5. patients must have achieved a complete response to therapy 6. eastern cooperative oncology group (ecog) performance status of 0 or 1 at treatment period initiation 7. adequate hematological, hepatic and renal functions. exclusion criteria: 1. patient having received any cancer immunotherapy including cancer vaccines, any antibody/drug targeting t cell co-regulatory proteins such as anti-programmed cell death 1 (anti-pd1), anti-programmed death-ligand 1 (anti-pdl1) or anti-cytotoxic t-lymphocyte-associated protein 4 (anti-ctl4) 2. patients with other active malignancy ≤ 3 years prior to registration except non-melanoma skin cancer, stage 0 in situ carcinoma. 3. patient post-organ transplantation, including allogeneic stem cell or bone marrow transplantation. 4. known history of positive testing for human immunodeficiency virus (hiv) or known aids (acquired immune deficiency syndrome). 5. any known allergy or reaction to eggs or attributed to compounds of similar chemical or biological composition to therapeutic vaccines/immunotherapeutic products. 6. acute or chronic infection with hepatitis c virus (hcv) or hepatitis b virus (hbv). 7. major surgery within 4 weeks of treatment start. 8. treatment with another investigation agent within 30 days prior to tg4050 treatment initiation. 9. patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs . steroids with no or minimal systemic effect (topical, inhalation) are allowed. 10. use of live vaccine for the prevention of infectious diseases during the four-week period prior to tg4050 treatment initiation planned date. furthermore, patients should not receive any live vaccine during the period of study treatment administration. 11. uncontrolled intercurrent illness.
clinical trial to evaluate ant-1403 in the treatment of primary axillary hyperhidrosis

Conditions: Primary Axillary Hyperhidrosis

Summary: the purpose of this study is to confirm the effect of ant-1403 in the treatment of primary axillary hyperhidrosis.


Eligibility criteria:
inclusion criteria: * ages 18 - 70 years of age * diagnosis of moderate to severe primary axillary hyperhidrosis * ≥50 mg of sweat production/axilla in 5 minutes as measured gravimetrically * hdss score of ≥3 exclusion criteria: * diagnosis of secondary hyperhidrosis * skin affliction in the axilla requiring medical treatment * 20% aluminum hydrochloride, e.g. drysol®, in 2 weeks prior of baseline * oral anticholinergic treatment * botulinum toxin treatment in the prior 9 months * history of surgery for axillary hyperhidrosis * present or history of neuromuscular disease * female subjects who are pregnant or are nursing a child
a study to evaluate the safety and efficacy of atorvastatin in patients with diabetes and high cholesterol

Conditions: Hyperlipidemias

Summary: the purpose of this study is to evaluate the efficacy and safety of atorvastatin for the treatment of taiwanese patients with diabetes and high cholesterol.


Eligibility criteria:
inclusion criteria: * adult taiwanese outpatients with type 2 diabetes mellitus and high cholesterol * hemoglobin a1c levels of ≤10%, ldl-c levels of ≥130 mg/dl, and serum triglyceride levels of \<400 mg/dl exclusion criteria: * type i diabetes mellitus * secondary causes of high cholesterol * elevated liver enzymes
study comparing the affect of bifeprunox vs olanzapine on weight during the treatment of outpatients with schizophrenia.

Conditions: Schizophrenia

Summary: this study will compare bifeprunox to a currently marketed medication, zyprexa (olanzapine), with respect to the affect on weight during the treatment of outpatients with schizophrenia. the study will compare the effect of these medications on several variables, including body weight and triglyceride levels.

this is a multicenter, randomized, double-blind, parallel-group study of bifeprunox in the treatment of outpatients with schizophrenia, with olanzapine as the active comparator. subjects must be stable for 3 months or more of treatment with olanzapine at baseline. there will be 2 treatment arms in this study, approximately 60 subjects per arm. after randomization and blinding, each subject will either remain on olanzapine or switch to bifeprunox. assessments, including body weight and waist measurements, will be made at each study visit.subjects will participate in the study for approximately 11 weeks. after a screening period of 6 to 14 days, eligible subjects will be treated for 8 weeks. subjects who do not enter the long-term extension will return for a follow-up visit 7 days after discontinuing the use of test article. subjects who do enter the long-term extension will have a 7-day taper/titration period after the 8 weeks of double-blind treatment.

Eligibility criteria:
inclusion criteria: * current treatment of at least 3 months with olanzapine. * primary diagnosis of schizophrenia. * total positive and negative symptoms scale (panss) score \<=70 at screening and baseline. exclusion criteria: * psychiatric diagnosis other than schizophrenia, as assessed by the modified mini international neuropsychiatric interview (mini), and considered by the investigator to be the primary psychiatric diagnosis. * history or presence of clinically significant cardiovascular, endocrine, hepatic, renal or other medical disease that might be detrimental to the subject or confound the study. * history of any suicide attempt within 3 years of day -1 or significant immediate risk of violence or suicidality.

Keywords: schizophrenia
endoscopic treatment of non-variceal upper gi-bleeding with high risk of recurrency - otsc (over-the-scope-clip) versus standard therapy (sting2)

Conditions: Acute Upper Gastrointestinal Hemorrhage

Summary: prospective-randomized multi-center trial. patients with high risk of recurrent gi-bleeding (non-variceal) are identified and randomized into either endoscopic treatment with the otsc \[over the scope clip\] or endoscopic standard therapy. hypothesis: endoscopic therapy with otsc is superior to standard therapy regarding technical success and rebleeding.

prospective-randomized multi-center trial. patients with high risk of recurrent gi-bleeding (non-variceal) are identified (rockall score \> 6) and randomized into either endoscopic treatment with the otsc \[over the scope clip\] or endoscopic standard therapy. 100 patients are planned. hypothesis: endoscopic therapy with otsc is superior to standard therapy regarding technical success and rebleeding.

Eligibility criteria:
inclusion criteria: * upper gi-bleeding (non-variceal) with high risk of recurrency * 18 years and older exclusion criteria: * variceal-bleeding * under 18 years * pregnancy or nursing period * malignancy * need for surgical treatment (for example perforation with peritonitis)
repetitive transcranial magnetic stimulation to reduce heroin cravings

Conditions: Opioid-use Disorder; Heroin Abuse; Craving; Transcranial Magnetic Stimulation

Summary: the purpose of this research study is to test the effect of repetitive transcranial magnetic stimulation (rtms) on opioid cravings among adult patients with opioid use disorder.

this study will use rtms, a neuromagnetic and non-invasive treatment, to reduce opioid cravings in individuals who are diagnosed with opioid use disorder. repetitive transcranial magnetic stimulation is currently used for the treatment of major depressive disorder and obsessive compulsive disorder in clinical practice. this proposed study will employ a randomized, single-blind, experimental design. participants will be randomly assigned to two groups using a computer-based randomization program: treatment and sham-control groups.

Eligibility criteria:
inclusion criteria: * adult aged 18-64, used heroin in the past 30 days; * has a history of heroin use for at least one year; * meets the clinical criteria for opioid use disorder (only heroin use will be considered to meet this criteria); * meets the clinician clearance using the rtms patient screening form. exclusion criteria: * do not currently take and medications for a substance use disorder such as methadone, buprenorphine, naltrexone, acamprosate, disulfiram; * do not have a psychotic disorder; * do not have a diagnosis of another substance use disorder; * do not have a history of seizures or other neurological disorders including organic brain disease; epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery; * do not have a personal history of head trauma that resulted in a loss of consciousness for more than 5 minutes and retrograde amnesia for more than 30 minutes; * do not have a presence of non-fixed metal in body 30 cm to treatment coil. * have not taken any medication for a substance use disorder within the last 72 hours before the first rtms treatment; * are not pregnant or think you may be pregnant.
low dose continuous administration of the progesterone receptor modulator va2914

Conditions: Contraception; Gynecologic Diseases

Summary: the purpose of the present study is to evaluate continuous administration of low doses of va2914 for potential contraceptive activity and effects on the menstrual cycle and steroid hormone parameters.


Eligibility criteria:
inclusion criteria: * women in good general health with regular, ovulatory menstrual cycles * age 18-35 * not pregnant * not sexually active or reliably use barrier methods of contraception * normal liver and renal functions and normal laboratory exams exclusion criteria: * pregnant or breastfeeding * oral contraception, iud or other hormonal treatment * use of agents known to induce hepatic p450 * cardiovascular disorder * hepatic, renal, or gastrointestinal disorder * metrorrhagia * abnormal transvaginal ultrasound (at baseline) * history of abnormal endometrial biopsy, * cancer * depression * mental illness * epilepsy * migraines * abnormal pap smear requiring further exploratory examination * anovulatory cycle before treatment * extreme overweight or underweight (body mass index \ 28) * subjects unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study * use of narcotics * more than 10 cigarettes per day, more than 2 glasses of wine/beer per day * surgical procedures planned in the 6 months following screening visit

Keywords: progesterone receptor modulator
an observational study of adjuvant (post-surgery) therapy with nivolumab for resected (completely removed) melanoma in australia

Conditions: Melanoma

Summary: this study is designed to estimate the effectiveness of nivolumab when given to participants after removing their cancer with surgery, over a 5-year follow-up, in real-world conditions in australia.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * adults with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete surgical removal and have no evidence of disease * decision to treat with adjuvant nivolumab therapy has already been taken * ability to provide written informed consent to participate in the study exclusion criteria: * adults with a current diagnosis of persisting advanced melanoma * adults currently enrolled in an interventional clinical trial for his/her melanoma treatment other protocol-defined inclusion/exclusion criteria apply

Keywords: adjuvant nivolumab
wearable suicidal early warning system for adolescents

Conditions: Suicide; Adolescent Behavior

Summary: this study is prospectively enrolling a cohort of adolescent patients who present to the emergency department and an inpatient psychiatric adolescent unit with acute suicidality.

this study is prospectively enrolling a cohort of adolescent patients who present to the emergency department with acute suicidality or are admitted to an inpatient psychiatric adolescent unit. the plan is to monitor basic physiologic parameters to assess for trends associated with suicidality noninvasively in an objective manner beyond subjective questionnaires currently available. upon discharge they will be sent home with a noninvasive monitor to track physiologic parameters.

Eligibility criteria:
inclusion criteria: * acute suicidality * consenting individual present in the emergency department exclusion criteria: * medical admission for an ingestion or other reason

Keywords: suicide
open-label, dose escalation study of safety and preliminary efficacy of tn-401 in adults with pkp2 mutation-associated arvc

Conditions: Arrhythmogenic Right Ventricular Cardiomyopathy

Summary: this first-in-human study is designed to evaluate the safety, and preliminary efficacy (pd) of tn-401 gene therapy in adult patients with symptomatic pkp2 mutation-associated arvc.

the ridge-1™ open-label safety, tolerability, dose-finding, pd and cardiac transgene expression study will enroll up to 15 patients in two planned dose cohorts. patients in each cohort will receive a single intravenous (iv) dose of tn-401. following data safety monitoring board (dsmb) review of each dose cohort, the next dose cohort will be initiated. dsmb review will also be needed to expand the dose cohorts. the dose for cohorts 1/1a will be 3e13 (3 × 1013) vg/kg and the dose for cohorts 2/2a will be 6e13 (6 × 1013) vg/kg.

Eligibility criteria:
inclusion criteria: * pkp2 mutation (pathogenic or likely pathogenic) * arrhythmogenic right ventricular cardiomyopathy as defined by the 2010 revised task force criteria * left ventricular ejection fraction ≥50% * functioning implantable cardiac defibrillator with remote integration capabilities at least 9 months prior to screening * nyha functional class i, ii, or iii * frequent premature ventricular contractions (pvcs) exclusion criteria: * ventricular tachycardia (vt) ablation within 6 months of screening or planned vt ablation within 6 months after screening * high aav9 neutralizing antibody titer * prior myocardial infarction * right ventricular heart failure * class iv heart failure * clinically significant renal disease * clinically significant liver disease

Keywords: pkp2 mutation arrhythmogenic right ventricular cardiomyopathy (arvc) arrhythmogenic cardiomyopathy (acm) pkp2-associated arvc pkp2-arvc pkp2-acm adeno associated virus (aav) gene therapy gene transfer genetic cardiomyopathy heart failure
study to assess the efficacy and safety of nbi-1065845 as an adjunctive treatment in participants with major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: the study will evaluate the efficacy of nbi-1065845 compared with placebo as an adjunctive treatment in participants with mdd on improving symptoms of depression.


Eligibility criteria:
key inclusion criteria: * participant has a primary diagnosis of recurrent mdd (moderate or severe) or persistent depressive disorder. * participant has had an inadequate response to oral antidepressant treatments in the current episode of depression. * participant must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study. * total hamilton depression rating scale-17 item (ham-d17) score ≥22 at screening and at study baseline (day 1). * willing and able to comply with all study procedures and restrictions in the opinion of the investigator. key exclusion criteria: * a current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than mdd. * are considered by the investigator to be at imminent risk of suicide or injury to self or others. * participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ect) in the current major depressive episode.

Keywords: mdd depression major depressive disorder nbi-1065845 tak-653 madrs
evaluation of the neoadjuvant treatment with oxaliplatin -uft- radiotherapy in rectal cancer

Conditions: Rectal Neoplasms

Summary: primary objective: - to evaluate the rate of responses to neoadjuvant therapy + radiotherapy secondary objective: - tolerability (toxicity) and time to progression


Eligibility criteria:
the following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. this information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional. main criteria are listed hereafter: inclusion criteria: * patients with measurable, histologically proven rectal cancer. * no history of previous malignancy but adequately treated skin / cervical cancer. * adequate haematological, renal and liver function. exclusion criteria: * no cardiopulmonary insufficiency or coronary disease. no sensory neuropathy prior to study.