Kornimate/medical-research-clean huggingface dataset:
epidemiology of persistent pulmonary hypertension of the newborn - scor in lung biology and diseases in infants and children

Conditions: Lung Diseases; Cardiovascular Diseases; Defect, Congenital Heart; Heart Diseases; Persistent Fetal Circulation Syndrome

Summary: to conduct an epidemiologic study of persistent pulmonary hypertension of the newborn ( pphn) infant.

background: the study on the epidemiology of persistent pulmonary hypertension of the newborn (pphn) was a subproject within a specialized center of research (scor) in lung biology and diseases in infants and children. the scor and its subproject were awarded in december, 1991. dollars were estimated at 20 percent of total center dollars. design narrative: data from a previous study of pphn were analyzed. the objectives were to: identify the effects of a variety of potentially adverse prenatal exposures from interview data; formulate multi-variate models of risk of pphn to determine if smoking or use of prostaglandin inhibitors increased the risk of pphn; explore associations of pphn with history of illicit drug use and maternal hypoxia; examine the relationships of postnatal care and perinatal risk factors on the incidence and outcome of pphn; test the relationships of pphn to the biochemical presence of nicotine and drugs in neonatal urine. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
a long term study of ym060 in female patients with diarrhea-predominant irritable bowel syndrome

Conditions: Diarrhea-predominant Irritable Bowel Syndrome

Summary: to evaluate the efficacy and safety of ym060 once daily for female patients with diarrhea-predominant irritable bowel syndrome (d-ibs) for a long-term period (up to 52 weeks).


Eligibility criteria:
inclusion criteria: female patients who meet the following criteria: 1. patients satisfying the rome iii diagnostic criteria 2. patients whose ≥25% of stools were loose or watery and \<25% of them were hard or lumpy stools 3. patients who have abdominal pain or discomfort 4. patients in whom after occurrence of ibs symptoms the following tests were conducted and in whom no organic changes were observed pancolonoscopy or contrast enema exclusion criteria: patients who meet any of the following criteria: 1. patients with a history of surgical resection of the stomach,gallbladder, small intestine or large intestine 2. patients with a history or current evidence of inflammatory bowel disease 3. patients with a history or current evidence of colitis ischemic 4. patients with concurrent infectious enteritis 5. patients with concurrent hyperthyroidism or hypothyroidism 6. patients with concurrent active peptic ulcer 7. patients with other concurrent disease that may affect the digestive tract passage or large intestinal function or that is likely to interfere with proper assessment of ibs abdominal pain/discomfort

Keywords: ym060 ramosetron long term study diarrhea-predominant irritable bowel syndrome female
the study of fluconazole for vulvovaginal candidiasis

Conditions: Vulvovaginal Candidiasis

Summary: as for the indication of vulvovaginal candidiasis, a single oral administration of fluconazole 150 mg has been approved and is recommended by guidelines overseas. however in japan oral therapy with antifungal triazole such as fluconazole has not been approved, and topical therapies such as vaginal tablets, pessary and cream are used clinically. the purpose of this trial is to confirm the efficacy and safety of single oral administration of fluconazole 150 mg for the treatment of vulvovaginal candidiasis in japanese patients.


Eligibility criteria:
inclusion criteria: * patients with clinical symptoms and signs of vulvovaginal candidiasis. * patients tested positive for candida by fungal culture. * patients who can agree not to have intercourse up to 28 days after dosing. exclusion criteria: * patients with a history of hypersensitivity to fluconazole. * patients with severe renal dysfunction. * patients with liver disorder.
comparison between injection molded peek framework and cobalt chromium framework removable partial dentures regarding biting force

Conditions: Mandibular Prosthesis User

Summary: this study is aiming to evaluate the biting force of polyetheretherketone (peek) framework partial dentures compared to that of cobalt-chromium ones in mandibular kennedy class i edentulous cases hoping that polyetheretherketone (peek) framework removable partial dentures can improve the patient masticatory efficiency .


Eligibility criteria:
inclusion criteria: -kennedy class 1 partially edentulous subjects indicated for framework partial denture exclusion criteria: * uncooperative patients * bad oral hygiene patients
safety and efficacy of irinotecan plus capecitabine as first-line treatment in asian subjects with hepatocellular carcinoma

Conditions: Carcinoma, Hepatocellular

Summary: to evaluate the safety and efficacy of irinotecan and capecitabine in asian subjects with inoperable hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * asian subjects with histologically or cytologically confirmed hepatocellular carcinoma * inoperable disease (unable to completely remove surgically, presence of extra-hepatic disease, main portal vein or hepatic vein involvement) * eastern cooperative oncology group performance status of ?2 exclusion criteria: * decompensated cirrhosis or stage c (index\>10) according to the child-pugh classification * current history of chronic diarrhoea * reproductive potential not using adequate contraceptive measures
impact of hi-nppv vs li-nppv on tolerance among aecopd patients

Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Summary: to determine whether high-intensity nppv, compared with low-intensity nppv, could have an effect on the subjective tolerance in patients with an aecopd and hypercapnia.

to evaluate the subjective tolerance of high-intensity nppv and low-intensity nppv patients in a conscious state by two questionnaire surveys; to assess tolerance of high-intensity nppv and low-intensity nppv patients patient in sleeping status by psg monitoring.

Eligibility criteria:
inclusion criteria: * aecopd confirmed by the 2019 criteria of the global initiative for chronic obstructive lung disease (gold); * arterial ph \ 45 mmhg at screening entry; * paco2 \>45 mmhg after a 6-hour trial of low-intensity nppv. exclusion criteria: * age \<18 years * excessive respiratory secretions with weak cough * upper airway obstruction * recent oral, facial, or cranial trauma or surgery * recent gastric or esophageal surgery * presence of restrictive ventilatory dysfunction (eg, consolidation or removal of at least one pulmonary lobe, massive pleural effusion, chest wall deformity, continuous strapping with thoracic or abdominal bandage, or severe abdominal distension) * active upper gastrointestinal bleeding * cardiac or respiratory arrest * arterial oxygen tension/fraction of inspired oxygen (pao2/fio2) \<100 mmhg * pneumothorax * obvious emphysematous bullae confirmed by chest ct scan * ventricular arrhythmia or myocardial ischemia * severe hemodynamic instability (mean arterial pressure \<65 mmhg) * severe metabolic acidosis (ph \<7.20 and bicarbonate \<22 mmol/l) * refusal to receive nppv or give informed consent * prior endotracheal intubation or tracheostomy during the current hospitalization * a do-not-intubate order
effects of propofol and isoflurane on pulmonary vascular resistance

Conditions: Hypertension, Pulmonary

Summary: the investigators hypothesize that there is no difference between the effects of isoflurane and propofol anaesthesia on pulmonary vascular resistance (pvr).


Eligibility criteria:
inclusion criteria: * all children between 3 months and 16 years of age with pulmonary arterial hypertension undergoing a pvr study. exclusion criteria: * children with a known adverse reaction to one of the study drugs eg malignant hyperpyrexia or a disorder of fatty acid oxidation.

Keywords: propofol isoflurane pulmonary hypertension congenital heart disease
touch screen usage time in relation to visual motor integration and quality of life in preschoolers

Conditions: Child Development

Summary: recent literatures are associating digital technology extensive and addictive use with physical, psychosocial and cognitive inverse consequences. this research focuses more on number of touch screen devices; age started using devices and usage time in relation to cognitive function in preschoolers.

a hundred typically developing preschool children of both genders with age ranges from three to five years will be included in this study. visual motor integration, quality of life and cognitive function were assessed by the peabody developmental motor scale, the pediatric quality of life inventory™ and the pediatric quality of life inventory™ cognitive functioning scale respectively sample size to avoid type ii error, sample size calculation was based on data from a pilot study on correlation between touch screen usage time and visual motor integration. using g\*power statistica software (version 3.1.9.2; franz faul, universitat kiel, germany) \[correlational study, α=0.05, β=0.2, and medium effect size = 0.3\] revealed that the appropriate sample size for this study was n=84 therefore, one-hundred children were recruited for possible dropouts during assessment.

Eligibility criteria:
inclusion criteria: children were enrolled in this study according to the following criteria: * age ranges from three to five years. * both genders were included. exclusion criteria: children were excluded from the study if they had any of the following criteria: * diagnosed with attention deficit/hyperactivity disorder (add/adhd) or developmental co-ordination disorder (dcd). * preterm children; children with major physical disabilities, genetic disorders; prenatal exposure to alcohol; children with a history of head trauma and infections. * diagnosed with psychiatric conditions such as autism and depression. * diagnosed with significant behavioral disorders * diagnosed with fine motor problems. * significant auditory or visual deficits.

Keywords: cognitive development digital devices quality of life inventory visual motor integration touch screen usage
levosimendan and myocardial protection

Conditions: Myocardial Protection

Summary: the aim of this study is to investigate whether pharmacological pre-treatment with levosimendan reduces intensive care unit (icu) length of stay in patients undergoing elective myocardial revascularization under cardiopulmonary bypass.


Eligibility criteria:
inclusion criteria: * age ≥18 years * intention to perform first-time multi-vessel cabg exclusion criteria: * unstable angina * valvular disease * diabetes mellitus treated with sulphonylurea drugs * renal failure * severe hepatic disease * severe chronic obstructive pulmonary disease * a history of prior cabg surgery * recent myocardial infarction (mi) within the previous month

Keywords: levosimendan pre-conditioning cardiac surgery myocardial function contractility heart ischaemia
a study to evaluate the safety, tolerability and efficacy of xen1101 in major depressive disorder

Conditions: Major Depressive Disorder

Summary: this is a multicenter, phase 2, double-blind, randomized, parallel-arm, placebo-controlled clinical trial to evaluate the efficacy, safety, and tolerability of xen1101 in subjects with major depressive disorder.

the study is divided into 3 stages: screening - up to 4 weeks duration; treatment - 6 weeks duration; follow-up - 4 weeks duration. the total study duration per subject is estimated to be approximately 14 weeks.

Eligibility criteria:
key inclusion criteria: * be properly informed of the nature and risks of the study and given written informed consent. * male or female, aged 18 through 65 years (inclusive) with a body mass index (bmi) ≤35 kg/m². * subject must meet the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for current mdd and currently in a moderate to severe major depressive episode (mde), confirmed using the mini international neuropsychiatric interview (mini). * current mde duration ≥2 months and \<24 months at the time of screening. * current illness severity that is at least moderate, defined as a score of ≥20 on the ham-d17 at screening and on day 1. * score ≥20 on the shaps at screening and on day1. * must be willing to comply with the study protocol for the full term of the study. key exclusion criteria: * a primary psychiatric diagnosis other than mdd as defined by dsm-5 (comorbid anxiety disorders \[including agoraphobia, generalized anxiety disorder, social anxiety disorder, post-traumatic stress disorder (ptsd), and panic disorder\] are allowed). * concomitant use of antidepressants and/or other disallowed pharmacotherapy (including benzodiazepines). * history of schizophrenia or other psychotic disorder, mdd with psychotic features, bipolar i or ii disorder, or mdd with mixed features. * history of non-response to \>1 antidepressant drug due to lack of efficacy in the current mde. * failing \>3 antidepressant drug trials, for any reason, in the current mde. * history of non-response to electroconvulsive therapy (ect) in the past 10 years. * active suicidal plan/intent in the past 6 months, or more than 1 lifetime suicide attempt. * females who are pregnant, breastfeeding, or planning to become pregnant during the first administration of study drug until 3 months after the last dose of study drug. * meets criteria for a substance use disorder within the past 12 months, with the exception of tobacco use, and/or has a positive urine toxicology screen for drugs of abuse. * any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.

Keywords: major depressive disorder potassium channel depression
mitochondrial biomarkers in huntington's disease

Conditions: Huntington Disease

Summary: the objective of this study is to discover a panel of mitochondrial metabolomics biomarkers for huntington's disease.

this investigator-initiated, single-site longitudinal study seeks to assess the utility of mitochondrial metabolomics -- panels of small molecules that affect mitochondrial function -- to diagnose pre-symptomatic, pre-manifest, and symptomatic huntington's disease and serve as biomarkers for hd severity and progression. it also seeks to demonstrate that this novel biomarker in the blood has comparable value to the same analysis in spinal fluid. this research study involves 3-4 visits over 18 months. forty volunteers with hd and 25 volunteers without hd will be included. volunteers who have hd will have a physical examination and blood draw at each study visit. some participants will also volunteer for optional lumbar puncture.

Eligibility criteria:
inclusion criteria: * age 20 to 85 * montreal cognitive assessment score \>10 * hd subjects had onset of hd symptoms after the age of 20 * hd subjects with diagnostic confidence level (dcl) of 0-3 (pre-symptomatic or pre-manifest) must have at least 40 cag repeats on one htt allele * hd subjects with diagnostic confidence level (dcl) of 4 (manifest) must have at least 36 cag repeats on one htt allele * controls are asymptomatic without family history of hd or have \<36 cag repeats on both htt alleles with family history of hd exclusion criteria: * hd subjects who did not already have genetic testing are excluded from this study * pregnancy or plans to become pregnant during the study * investigational drugs within 3 months of screening visit * alcohol or illicit drug abuse or dependence * other genetic or neurological disorders * other medical or psychiatric illness that in the investigator's judgement will prevent ability to tolerate or undergo study procedures * for those volunteering for lumbar puncture (lp), bleeding disorders or excessive bleeding, anticoagulation, aspirin if unable to safely stop taking it at least 7 days prior to lp, other antiplatelet medications, inability to tolerate lp, allergy to local anesthetic or chlorhexidine, major lumbar spine deformity, low platelets or abnormal coagulation factors pt/aptt

Keywords: huntington disease huntington's disease biomarker
cognitive behavioral therapy for adult attention deficit hyperactivity disorder

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: this study will determine the effectiveness of cognitive behavioral therapy (cbt) in treating the symptoms of attention deficit hyperactivity disorder (adhd) in adults who have not responded to drug treatment. study hypothesis: cbt is an effective treatment for adult adhd.

adhd, previously believed to be a disorder of childhood, affects as many as 5 percent of adults. adults with adhd are at high risk for academic and occupational underachievement, relationship difficulties, and reduced quality of life. this study will determine whether cbt is more effective than drug therapy in treating adhd symptoms in adults who have been resistant to previous drug therapies. participants will be randomly assigned to receive 12 to 15 weekly sessions of either cbt or drug therapy which may include new or previously taken drugs. questionnaires will be used to assess participants' adhd symptoms at study start and at study completion.

Eligibility criteria:
inclusion criteria: * adult adhd of at least moderate severity * on current drug therapy for adhd exclusion criteria: * depression, panic disorder, bipolar disorder, organic mental disorders, psychotic disorders, or pervasive developmental disorders * current substance abuse or dependence * iq less than 90 * suicide risk * history of cognitive behavioral therapy

Keywords: adult adhd add
mechanisms of type 1 diabetes endophenotypes

Conditions: Type 1 Diabetes Mellitus; Genetic Predisposition to Disease

Summary: the goal of this observational study consists of performing cluster analysis to decipher underlying disease mechanisms of type 1 diabetes in children and young adults. to this end, we will combine clinical, laboratory, genetic, transcriptomic, and metabolomic datasets of an extensively phenotyped cohort of children and young adults with type 1 diabetes. we will also assess the risk for cardiovascular diseases in this most vulnerable diabetes cohort.


Eligibility criteria:
inclusion criteria (type 1 diabetic patients): * informed consent as documented by signature * patient's age: between 0 and 25 years old. * children, adolescents, and young adult patients followed in diabetology. exclusion criteria (type 1 diabetic patients): * no exclusion criteria inclusion criteria (controls): * informed consent as documented by signature * patient's age: 25 less than 6 years of age and 25 between 6 and 25 years old. * healthy patient exclusion criteria (controls): * patient receiving treatment affecting metabolic control (ex: systemic corticoids, beta blocker, immunotherapy etc.) * concomitant disease that may affect the analysis of the results (ex: cancer, active autoimmune disease requiring treatment)

Keywords: type 1 diabetes mellitus children adolescent young adult genetic transcriptomic metabolomic lipidomic genetic risk score
combination chemoembolization and radiofrequency ablation for hepatocellular carcinoma greater than 3 cm

Conditions: Hepatocellular Carcinoma

Summary: combined the chemoembolization and radiofrequency ablation for the hepatocellular carcinoma greater than 3 cm,the ablation volume of coagulation necrosis can be significantly increased,which may be enable effective treatment of patients with hcc greater than 3 cm.

to assess whether the effectiveness of a combination of transcatheter arterial chemoembolization(tace) and radiofrequency ablation(rfa) is superior to tace and rfa alone in treatment of patients with hepatocellular carcinoma(hcc)greater than 3 cm and to analyze the factors affecting the outcomes. the patients with hcc of 3 or fewer lesions, each 3cm greater in diameter entered this randomized controlled trial. the primary end point was survival, and the secondary end points were tumor response.

Eligibility criteria:
inclusion criteria: eligibility criteria were: 1. not indicated for resection, 2. liver function of child-pugh class a or b, 3. 3 or fewer lesion, each 3 cm greater and 7.5 cm less in greatest diameter, 4. no portal vein involvement or extrahepatic metastasis, 5. lesions located at least 5mm away from the hepatic hilum or gall bladder and the common bile duct, 6. platelet count≥6.0×103/mm3 and the prothrombin activity≥60%, and 7. no previous hcc treatment. exclusion criteria: exclusion criteria were: 1. encephalopathy, 2. refractory ascites, 3. active gastrointestinal bleeding, 4. renal failure.

Keywords: hepatocellular carcinoma,treatment
erlotinib in treating patients with advanced non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. purpose: this phase ii trial is studying how well erlotinib works in treating patients with advanced non-small cell lung cancer.

objectives: primary * determine the major objective response rate (partial response and complete response) in patients with advanced bronchoalveolar cell non-small cell lung cancer treated with erlotinib hydrochloride. secondary * assess the quality of life of patients treated with this regimen. * determine the duration of response and time to disease progression in patients treated with this regimen. * determine the median survival of patients treated with this regimen. outline: this is an open-label, nonrandomized, multicenter study. patients receive oral erlotinib hydrochloride daily in the absence of disease progression or unacceptable toxicity.

Eligibility criteria:
disease characteristics: * histologically confirmed bronchoalveolar cell (or a variant) non-small cell lung cancer (nsclc) * stage iiib (malignant pleural or pericardial effusion) disease * stage iv disease * recurrent and/or medically inoperable disease * measurable or evaluable indicator lesions * no uncontrolled cns metastases (i.e., any known cns lesion that is radiographically unstable, symptomatic, and/or requiring escalating doses of corticosteroids) patient characteristics: * ecog performance status (ps) 0-1 or karnofsky ps 80-100% * life expectancy ≥ 8 weeks * wbc ≥ 3,000/mm³ * hemoglobin ≥ 9.0 g/dl * platelet count ≥ 100,000/mm³ * bilirubin ≤ 1.0 mg/dl * ast ≤ 2 times upper limit of normal * creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 55 ml/min * not pregnant or nursing * fertile patients must use effective contraception * no significant medical history or unstable medical condition, including any of the following: * unstable systemic disease * congestive heart failure * recent myocardial infarction * unstable angina * active infection * uncontrolled hypertension * no other active malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal cell or squamous cell skin cancer prior concurrent therapy: * see disease characteristics * at least 3 weeks since prior radiation therapy to a major bone marrow-containing area * at least 3 weeks since prior chemotherapy * no more than 1 prior chemotherapy regimen for nsclc * no prior systemic cytotoxic chemotherapy for other malignant diseases * no prior erlotinib hydrochloride or other agents targeting the her family (e.g., cetuximab, trastuzumab \[herceptin®\], or gefitinib) * no concurrent radiotherapy or chemotherapy

Keywords: stage iiib non-small cell lung cancer stage iv non-small cell lung cancer bronchoalveolar cell lung cancer recurrent non-small cell lung cancer