Kornimate/medical-research-clean huggingface dataset:
phase i study of adenoviral vector mediated gene transfer for ornithine transcarbamylase in adults with partial ornithine transcarbamylase deficiency

Conditions: Ornithine Transcarbamylase Deficiency Disease

Summary: objectives: i. determine the safety, feasibility, and potential efficacy of intravascular adenoviral vector mediated gene transfer in the liver in adults with partial ornithine transcarbamylase deficiency.

protocol outline: this is a dose escalation study. patients undergo a femoral arterial placement of a hepatic intraarterial catheter. patients then receive adenoviral vector mediated gene transfer intravascularly over 30 minutes. cohorts of 3 patients each receive escalating doses of adenoviral vector until the maximum tolerated dose is determined. patients are followed at 3, 5, 7, 8, 15, and 29 days, at 2 months, and then every 3 months thereafter. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * diagnosis of partial ornithine transcarbamylase deficiency female heterozygote with abnormal allopurinol challenge or underlying defect in either n15 urea or n15 glutamine or male with childhood/adulthood onset or family history of 2 affected children * stable for at least 1 month prior to study * plasma ammonium levels less than 50 micromoles --prior/concurrent therapy-- * concurrent alternate pathway therapy to control hyperammonemia allowed --patient characteristics-- * hepatic: no history of liver disease * other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception no high level of neutralizing antibodies to the adenovirus

Keywords: genetic diseases and dysmorphic syndromes inborn errors of metabolism ornithine transcarbamylase deficiency rare disease urea cycle disorder
a study to evaluate the effect of dapagliflozin on blood glucose level and renal safety in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with type 2 diabetes and moderate renal impairment.this study will be conducted at approximately 100 centres from countries across north america and european regions. it is planned to randomize a total of 302 patients.


Eligibility criteria:
inclusion criteria: * female or male aged ≥18 years and \<75 years. * history of t2dm for more than 12 months. * inadequate glycemic control, defined as hba1c ≥7.0% and ≤11% * stable anti-diabetic treatment regimen * renal impairment: ckd 3a exclusion criteria: * women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period. * history of diabetic ketoacidosis or hyperosmolar nonketotic coma. * severe uncontrolled hypertension defined as sbp ≥180 mmhg and/or diastolic blood pressure (dbp) ≥110 mmhg * any of the following cardiovascular (cv)/vascular diseases within 3 months of prior to signing the consent at visit 1: myocardial infarction, cardiac surgery or revascularization(cabg/ptca), unstable angina, unstable heart failure (hf), hf new york heart association (nyha) class iv,transient ischemic attack (tia) or significant cerebrovascular disease, unstable or previously undiagnosed arrhythmia. * history of any biopsy or imaging verifying intercurrent kidney disease (such as glomerular nephritis or sign of renal artery stenosis) other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis. * significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency. * ongoing treatment with any sglt2-inhibitor, glp-1 analogue, or rapid/short acting insulins at screening. * participation in another clinical study with an investigational product (ip) during the last 30 days prior to signing the consent at visit 1.
efficacy of bispectral index monitoring for midazolam and meperidine induced sedation during endoscopic submucosal dissection

Conditions: Gastric Adenoma; Gastric Cancer

Summary: background: endoscopic submucosal dissection (esd) usually requires adequate level of sedation due to lengthy and uncomfortable procedure. propofol induced sedation with bispectral index (bis) monitoring has been reported to lead to higher satisfaction of patients and endoscopists during esd. however, there is no data about efficacy of midazolam and meperidine induced sedation with bis monitoring during esd. this study was to evaluate whether midazolam and meperidine induced sedation with bis monitoring could improve the satisfaction and reduce the dose of midazolam and meperidine during esd.


Eligibility criteria:
inclusion criteria: * gastric adenomas, differentiated-type gastric cancers greater than 30 mm in diameter without ulceration and gastric cancers up to 30 mm with ulceration, or minute submucosal invasion exclusion criteria: * if they were under 18 years of age * had an asa classification of 4-5 * were pregnant * had a history of stroke or an allergy to sedative drugs.

Keywords: gastric adenoma early gastric cancer
a study to evaluate the efficacy and safety of karxt for the treatment of manic episodes in bipolar-i disorder

Conditions: Bipolar-I Disorder With Mania or Mania With Mixed Features

Summary: the purpose of this study is to evaluate the efficacy and safety of karxt for the treatment of manic episodes in bipolar-i disorder

this is a phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in subjects with bipolar disorder experiencing an acute episode of mania or mania with mixed features. the primary objective of the study is to evaluate the efficacy of karxt compared to placebo in treating symptoms of mania during a 3-week inpatient period. the duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.

Eligibility criteria:
inclusion criteria * participants must have a primary diagnosis of bipolar-i disorder established by a comprehensive psychiatric evaluation. * participants must be experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks). * participants must require hospitalization for the acute exacerbation or relapse of mania. * participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug. * participants must have a young mania rating scale (ymrs) score of ≥ 20 at screening and at baseline. * participants must have a clinical global impressions-bipolar (cgi-bp) ≥ 4 at screening and at baseline. exclusion criteria: * participants must not have any primary diagnostic and statistical manual of mental disorders (5th edition, text revision) (dsm-5-tr) disorder, other than bp-i with mania or mania with mixed features within 12 months before screening, including bp-i with depression (for previous 3 months only), bp-ii disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders. * participants must not have a primary diagnosis of bp-i with rapid cycling (≥ 4 distinct mood episodes in one year). * participants must not have a dsm-5-tr diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening, or current use as determined by urine toxicology screen or alcohol test. * participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the investigator's clinical assessment and the columbia-suicide severity rating scale (c-ssrs). * participants must not have a history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months. * participants must not have a history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: bipolar-i mania mixed
transcranial direct current stimulation (tdcs) on working memory in college going students

Conditions: Working Memory Deficits

Summary: working memory deficiencies, might make it difficult for students to recall instructions, complete complex activities, and grasp and follow directions solving a math problem or writing a sentence. the functions of working memory are critical for effective human activity. transcranial direct current stimulation (tdcs) has grown in popularity and academic interest in recent years as a way to improve cognitive abilities. so there is need to determine the effect of tdcs on working memory in college going students.


Eligibility criteria:
inclusion criteria: 1. college going students 2. both male and female 3. able to follow verbal commands exclusion criteria: 1. chronic skin problems. 2. seizure and any neurological disorder 3. any recent trauma or surgery 4. any cardiovascular or pulmonary disease 5. psychosomatic disorders

Keywords: working memory, immediate memory
monovision vs multifocal lens insertion in cataract patients

Conditions: Cataract

Summary: the investigators would like to assess whether monovision correction of multifocal lens insertion provides more satisfaction to cataract patients following an uncomplicated phacoemulsification surgery.


Eligibility criteria:
inclusion criteria: * bilateral senile cataract exclusion criteria: * glaucoma * corneal pathology * fundus pathology * severe neurological/mental diseases that interfere with visual acuity * former intraocular operation

Keywords: cataract phacoemulsification monovision multifocal lens
a personalized surveillance and intervention protocol for duodenal and gastric polyposis in patients with familial adenomatous polyposis

Conditions: Familial Adenomatous Polyposis

Summary: the purpose of this study is to determine the efficacy and safety of a personalized surveillance and intervention protocol for duodenal and gastric polyposis in patients with familial adenomatous polyposis (fap)

patients with fap are not only at risk of developing colorectal adenomas but also at high risk of developing duodenal adenomas. in 30% to 92% of fap patients duodenal adenomas are detected, with a lifetime risk approaching 100%. of these duodenal adenomas, only a small proportion develops into duodenal cancer, with a prevalence of approximately 5-10% in fap patients. endoscopic surveillance is nowadays the standard of care to prevent fap patients from developing duodenal cancer. the severity of duodenal polyposis is assessed using the spigelman classification system. this classification is based on the number, size, histology, and grade of dysplasia of the duodenal adenomas, resulting in a score varying from 0-iv, guiding surveillance intervals and treatment. concerns are rising on the accuracy of the spigelman score as predictor for duodenal cancer, especially for ampullary cancer. over the past years, multiple studies demonstrated limitations of this staging system including the fact that this classification does not adequately predict duodenal/ampullary cancer and does not guide endoscopic or surgical interventions. a clear endoscopic intervention protocol is needed, not only to prevent the development of cancer but also to prevent the need for duodenal surgery, since these surgical procedures are associated with high complication and mortality rates. with this study, the investigators aim to evaluate a personalized surveillance and intervention protocol for the duodenum and stomach with the goal to prevent the development of advanced neoplasia (an) by endoscopically removing lesions before they progress to an.

Eligibility criteria:
inclusion criteria: * diagnosis of fap, at least one of following: genetic diagnosis (proven apc germline mutation) and/or clinical diagnosis (\>100 colorectal adenomas in combination with a positive family history of fap) * age 18 years or older exclusion criteria: * endoscopic removal of all polyps with an indication for removal not possible/feasible * gastric or duodenal cancer at baseline endoscopy * need for surgery

Keywords: endoscopic surveillance endoscopic interventions personalized care gastrointestinal neoplasia
coherence imaging of the cervical epithelium with scanning a/lci

Conditions: Cervical Dysplasia

Summary: the purpose of this study is to develop a low coherence interferometry (lci) endoscopic probe that can examine the cervix for evidence of cervical dysplasia. the device will make optical measurements of the cervix to determine: 1. the difference between two different types of cervical cells: ectocervical cells and endocervical cells. cervical dysplasia is most likely to occur at the junction between these two types of cells. 2. features of individual cervical cells that indicate whether the cell is normal or abnormal (cervical dysplasia).


Eligibility criteria:
inclusion criteria: * able to provide informed consent * willing to abstain from sexual intercourse for at least 24 hours before study visit exclusion criteria: * pregnant * have a current gynecological infection or discharge * have had any cervical surgery * had medical or cosmetic surgery involving the reproductive organs or genitals within the past 6 months * currently enrolled in any research studies involving the application of vaginal formulations * employed or supervised by the study investigators * have any other condition, that, in the opinion of the study clinician, would contraindicate participation in the study
phase iii clinical study of azvudine in hiv-infected treatment naive patients

Conditions: HIV-infection/Aids

Summary: azvudine,(fnc)， new nuclear nucleoside reverse transcriptase inhibitors, fnc make itself a better candidate to be co-formulated in other anti-hiv therapies, thus to improve patient's compliance, approved by state drug administration (nmpa) for clinical research. fnc has completed its phase i、ii clinical studies with desirable results.this is a multi-center, randomized, double-blind,double-placebo,active-control clinical trial. subjects in experimental arm receives fnc+tdf+efv+3tc placebo, while the subjected in active control arm receives 3tc+tdf+efv+fnc placebo. the background drugs in both arms are conducted in open-label design while fnc and 3tc are conducted in double-blinded design.


Eligibility criteria:
inclusion criteria: 1. 18-65 years old, regardless of gender; 2. participant must have an positive hiv test; 3. have not received anti-hiv treatment; 4. hiv-1 rna≥1000 copies/ml and the investigators determined that the subjects were eligible for haart therapy. 5. who have no recent family planning and agree to take effective non-drug contraceptive measures during the trial period and within 3 months after the end of administration; 6. the subjects could fully understand the purpose, nature, method and possible adverse reactions of the test, and voluntarily participate in and sign the informed consent. exclusion criteria: 1. history of allergy to any ingredient or excipient of the research drug or have a high sensitivity constitution; 2. patients with severe opportunistic infection or tumor; 3. clinically hepatitis b surface antigen/hepatitis c antibody positive; 4. clinically alanine transaminase and/or alanine transaminase ≥5× normal upper limit (uln); 5. clinically alanine aminotransferase ≥3×uln and total bilirubin ≥2×uln (direct bilirubin/total bilirubin \> 35%); 6. glomerular filtration rate \< 70ml/min/1.73m2 (calculated by ckd-epi creatinine 2009 equation), or creatinine ≥uln; 7. clinically significant diseases serious chronic diseases , metabolic diseases (such as diabetes), neurological and psychiatric diseases; 8. history of pancreatitis; 9. women in pregnancy and breastfeeding; 10. history of drug abuse, alcohol abuse and drug abuse; 11. participating in clinical trials of other drugs within the first three months of screening; 12. other factors considered inappropriate by the investigator to be included in the study

Keywords: fnc hiv-infection aids
emotion regulation training for adolescents with adhd

Conditions: Attention Deficit Disorder With Hyperactivity; Emotion Regulation; ADHD

Summary: the goal of this single-case study is to pilot and evaluate a new psychological intervention (skills-er) targeting emotion regulation in adolescents with adhd. participants (n=9; 13-18 years of age) and their parents will partake in the intervention consisting of a total of eight sessions.

attention-deficit/hyperactivity disorder (adhd) results in functional impairment across several life domains and is associated with high comorbidity rates and negative long-term outcomes. for adolescents with adhd, emotional dysregulation constitute an increasing health problem. the ability to regulate one's emotions has been suggested as a major candidate for transdiagnostic sources of risk and/or resilience. a sample of adolescents (n=9; 13-18 years of age) with adhd and emotion dysregulation will participate in an emotion regulation intervention (skills-er) in order to evaluate feasibility, potential effectiveness and to detect mechanisms that could strengthen adaptive regulation skills. the emotion regulation programme will include eight weekly sessions, and although primarily directed towards the adolescent, parents will be invited and participate in some sessions. the researchers will apply a single-case multiple baseline design across participants with repeated measurements and pre-intervention baselines at different lengths (5, 6 and 7 weeks) to which participants are randomized. the researchers will analyze the data with a combination of visual and quantitative analyses, see study protocol and statistical analysis plan.

Eligibility criteria:
inclusion criteria: * adhd diagnosis * self- and/or parent-rated emotion regulation difficulties, as indicated via the emotion questionnaire (eq). exclusion criteria: * intellectual disability * autism * psychosis * bipolar disorder * severe depression * non-stabilized medication for adhd at intake (if on medication for adhd) * other ongoing psychological treatment
the effect of continuous positive airway pressure on diastolic function in patients with obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the association of obstructive sleep apnea (osa) and cardiac diastolic dysfunction have been reported, and improvement of diastolic function after continuous positive airway pressure (cpap) in osa patients was observed. however, more detailed analysis of diastolic function by supine bicycle exercise echocardiography is lacking. the investigators hypothesized that 3 months of cpap therapy in osa patients will significantly improve diastolic functional parameters measured by exercise stress echocardiography. patients with severe osa (apnea-hypopnea index \> 30) will be included in this study, and randomized to cpap versus sham-cpap group by 1:1 ratio. supine bicycle exercise echocardiography, pulse wave velocity, 24 hours ambulatory blood pressure (bp), central bp will be checked before and after cpap therapy and parameters will be compared.


Eligibility criteria:
inclusion criteria: * patietns≥20 and ≤75 years-old * patients who diagnosed as obstructive sleep apnea and ahi\>30 on polysomnography exclusion criteria: * age \< 20 years-old * left ventricular dysfunction (lvef\<50%) or structural heart disease on transthoracic echocardiography * diabetes mellitus * significant cardiac valvular disease (≥moderate) * severe hypertension (\>180/110mmhg) * moderate or severe kidney disease (egfr \< 60 ml/min ) * clinically significant liver disease * history of coronary artery disease * malignancy or autoimmune disease * acute/chronic infection status * pregnant status * patients taking anxiolytics or sedatives

Keywords: obstructive sleep apnea continuous positive airway pressure diastolic function
efficacy and long-term safety of ragweed (ambrosia artemisiifolia) sublingual tablet in adults with a history of ragweed-induced rhinoconjunctivitis with or without asthma (study p05233)(completed)

Conditions: Rhinitis; Allergic, With Asthma; Conjunctivitis

Summary: this study will evaluate the efficacy and safety of ragweed sublingual tablet (sch 39641/mk-3641) compared with placebo in participants with ragweed-induced rhinoconjunctivitis over a one-year period. it is expected that ragweed allergic participants on one of the active arms of the trial will have decreased allergic rhinoconjunctivitis symptoms and require less allergy rescue medications during ragweed pollen season.


Eligibility criteria:
inclusion criteria: * must have a clinical history of significant ragweed-induced allergic rhinoconjunctivitis of at least 2 years duration, with or without asthma and have received treatment during the previous rs. * must have a positive skin prick test response to ambrosia artemisiifolia at screening visit. * must be positive for specific immunoglobulin e (ige) against ambrosia artemisiifolia at screening visit. * must have an forced expiratory volume in 1 second (fev1) of at least 70% of predicted at screening visit. * safety laboratory tests and vital signs conducted at the screening visit must be within normal limits or clinically acceptable to the investigator/sponsor exclusion criteria: * clinical history of symptomatic seasonal allergic rhinitis and/or asthma having received regular medication, due to another allergen during or potentially overlapping the rs. * clinical history of significant symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the participant is regularly exposed. * receipt of an immunosuppressive treatment within 3 months prior to the screening visit (except steroids for allergic and asthma symptoms). * clinical history of severe asthma. * asthma requiring medium or high dose inhaled corticosteroids. * history of anaphylaxis with cardiorespiratory symptoms. * history of chronic urticaria and angioedema. * clinical history of chronic sinusitis 2 years prior to the screening visit. * current severe atopic dermatitis. * breast-feeding, pregnant, or intending to become pregnant. * had previous treatment by immunotherapy with ragweed allergen or any other allergen 5 years prior to screening visit. * history of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (except for ambrosia artemisiifolia), rescue medications, or self-injectable epinephrine. * history of self-injectable epinephrine use.