Kornimate/medical-research-clean huggingface dataset:
a trial of dextromethorphan and bupropion sustained-release tablets in patients with major depressive disorder

Conditions: Major Depressive Disorder (MDD)

Summary: a multicenter, randomized, double-blind, placebo-controlled, phase 3 trial, aim to evaluate the efficacy and safety of dextromethorphan and bupropion sustained-release tablets in chinese adult patients with major depressive disorder.


Eligibility criteria:
inclusion criteria: 1. male or female, age 18 - 65, inclusive 2. currently meets dsm-5 diagnosis of mdd without psychotic features, current major depressive episode of at least 4 weeks in duration at screening 3. identified as mdd by mini-international neuropsychiatric interview (m.i.n.i.) 4. madrs score ≥25 and cgi-s ≥4 at screening and baseline 5. the results of physical examination and laboratory tests during the screening period meet the test requirements 6. body mass index between 18 and 40 kg/m2, inclusive 7. for male subjects, use of an adequate method of birth control by the subject and by female sexual partners exclusion criteria: * 1. the researchers determined that it was refractory depression \[defined as in a current depressive episode or a previous depressive episode, after 2 or more antidepressants, a sufficient amount (in the maximum recommendation of the manual), a course of foot therapy (at least even continued medication for 4-6 weeks) ineffective after treatment\] 2. the madrs score improved by ≥ 25% at baseline compared with the screening period. 3. hospitalization in a psychiatric hospital during a current depressive episode 4. there is a clinically significant risk of suicide or self-harm and harm to others 5. screening patients tested positive for substance abuse 6. in the investigator's judgment, there are any clinically significant oncology, hematology, or internal diseases that are not suitable for entry into the study secretory/metabolic, cardiovascular, respiratory, kidney, liver, gastrointestinal, infectious or nervous system fever or suffer from an unstable or progressive chronic disease 7. hypertension 8. hypothyroidism or hyperthyroidism, except for the following cases: receiving stable medication with no change in dose for at least 1 month before screening (serum tsh must be \> 0.75×lln（ lower limit of normal ） and \ 2.0 × uln 14. according to the investigator's judgment, other conditions are not suitable for participating in this clinical study
a study to test the effectiveness of virulizin® given in combination with standard chemotherapy for pancreatic cancer

Conditions: Pancreatic Cancer

Summary: virulizin is an immunotherapy drug preparation that is thought to stimulate the patient's immune system, which in turn may slow the growth of tumors. it is presented in vials as a sterile preparation for im injection. the purpose of the trial is to investigate if virulizin in combination with gemcitabine provides better efficacy than gemcitabine alone (with placebo) against pancreatic cancer.virulizin® efficacy will continue to be assessed if chemotherapy is changed to 5-fluorouracil.

a phase iii, double-blind, multicenter, randomized study in chemonaive patients with locally advanced or metastatic pancreatic cancer to compare a combination therapy of virulizin® plus gemcitabine versus placebo plus gemcitabine; optional secondline therapy may include continuation of virulizin® or placebo, alone or in combination with 5-fluorouracil. patients who have not received any prior chemotherapy will be randomized to receive gemcitabine plus virulizin® versus gemcitabine plus placebo in a double blind fashion. on disease progression patients may be switched to 5-fluorouracil and continue to receive virulizin® or placebo. patients may continue virulizin® alone, if clinically indicated when 5-fluorouracil is discontinued.

Eligibility criteria:
* patients with advanced (unresectable or metastatic) pancreatic adenocarcinoma (tnm stages ii, iii or iv) * no previous systemic chemotherapy(unless given as a radiosensitizer). * ecog performance status 0-2 * life expectancy equal to or greater than 12 weeks * adequate laboratory and organ functions * stabilizable pain (stable analgesic intake) * no radiotherapy during 4 weeks prior to trial entry * no evidence of ascites, pleural effusion or third space fluid accumulation * not currently using, and have not used in 4 weeks prior to entering trial, systemic steroids or hormonal therapy

Keywords: virulizin immunotherapy pancreas pancreatic cancer clinical trial
can targeted elimination of b-cell depletion therapy and/or combination therapy on systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: this prospective randomized control trial is undertaken to evaluate the safety and efficacy of anti-cd20 monoclonal antibody, rituximab, used as 1. monotherapy, 2. in combination with cyclophosphamide, in the treatment of proliferative lupus nephritis, as compared with standard immunosuppressive therapy with cyclophosphamide and azathioprine.

twenty patients will be randomized into 3 treatment arms to receive: * rituximab of 1000 mg given 2 weeks apart. on day the of rituximab, and 'pulse' methylprednisolone 250mg iv be given followed by prednisolone 30mg/day from day 2 to day 5. * a treatment dose rituximab of 1000mg given 2 weeks apart and 'pulse' methylprednisolone 250mg iv be given followed by prednisolone 30mg/day from day 2 to day 5, and 'pulse' cyclophosphamide 500mg/m2 at baseline and day 14. * sequential therapy with oral cyclophosphamide (50 to 100 mg/day) for 6 months followed by azathioprine (up to 2.5mg/kg/day) for maintenance up to 12 months. oral prednisolone will be given at 0.5 mg/kg/day (up to 30 mg daily) for 4 weeks, tapered by 5 mg every 2 weeks thereafter until 5mg /day for the rest of the study period. all patients would be started on angiotensin converting enzyme inhibitors before commencement of the trial and to continue at the same dosage throughout the study period. patients who are on antimalarial agents and statins at baseline will be allowed to continue. clinical examination and laboratory investigations will be performed at 0, 4, 8, 12, 24, 36 and 48 weeks from the time of treatment. at each visit, patients will be evaluated for clinical manifestation of sle and side effects of therapy. laboratory parameters measured included the complete blood cell count with differential and platelet counts, chemistries survey, urinalysis, and 24- hour urinary for protein excretion and creatinine clearance.

Eligibility criteria:
inclusion criteria: * age \> 18 years * active proliferative lupus nephrites * biopsy confirmed active proliferative lupus nephritis within 3 months prior to enrollment * proteinuria \>= 2g/day * active urinary sediments * activity index of \>= 6 * elevated anti-double-stranded(anti-dsdna) level at baseline * agreement to practice birth control * sle according to the american college of rheumatology criteria * informed consent was obtained exclusion criteria: * pre-existing renal failure * history of cancer * human immunodeficiency virus infection * active hepatitis b or c infection * active tuberculosis * diabetes mellitus * a ny other chronic disease * unwillingness to comply with the protocol

Keywords: sle rituximab methylprednisolone cyclophosphamide
vvc sampling study for analysis validation

Conditions: Vulvovaginal Candidiasis

Summary: this is a biomarker multi-centre study to validate an extraction method of fungal and bacterial dna extracted from vaginal swabs from adult women with confirmed vvc. the study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for vvc symptoms. vaginal samples will be examined under a microscope for yeast forms (hyphae or pseudohyphae) or budding yeast. if the investigator assesses that the patient has vvc, based on examination and the potassium hydroxide (koh) test, two vaginal secretion samples will be collected by a vaginal swab. one sample will be cultured to verify the presence of candida and the other will be used for sequencing analysis of the vaginal microbiome. samples from a total of 10 women are planned to be taken.


Eligibility criteria:
inclusion criteria: 1. adult women aged 18 years or older 2. diagnosis of vvc, defined as having a white or creamy vaginal discharge plus the following findings: 1. at least 2 of the following signs and symptoms of vvc that are characterized as at least moderate: itching, burning, irritation, edema, redness, or excoriation. 2. potassium hydroxide (koh) or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts. 3. having decisional capacity and providing written informed consent 4. signed informed consent and willing and able to comply with all study requirements exclusion criteria: none
magnetic resonance imaging-guided implantation of cardioverter defibrillators

Conditions: Myocardial Infarction; Ventricular Tachycardia; Ventricular Fibrillation; Sudden Cardiac Death

Summary: implantable cardioverter-defibrillators (icd) are currently recommended for the primary prevention of sudden cardiac death (scd) in patients with a remote (\>6 weeks) myocardial infarction (mi) and a low (≤35%) left ventricular ejection fraction (lvef). ventricular tachycardia (vt) and/or ventricular fibrillation (vf), which are responsible for most scds, result from the presence of surviving myocytes embedded within fibrotic mi-scar. the presence of these surviving myocytes, as well as their specific arrhythmic characteristics, is not captured by lvef. hence, the use of lvef as a unique risk-stratifier of scd results in a low proportion (17 to 31%) of appropriate icd device therapy at 2 years. consequently, most patients with a prophylactic icd do not present vt/vf requiring icd therapy prior to their first-icd battery depletion. thus, many patients are exposed to icd complications, such as inappropriate shocks, without deriving any health benefit. therefore, the current implantation strategy of prophylactic icds, based on lvef only, needs to be improved in post-mi patients.


Eligibility criteria:
inclusion criteria: * age \> 18 years; * patients with a lvef≤35% assessed at least after a 40 to 90 days period (depending on the presence of coronary revascularization) following an index myocardial infarction; * left ventricular systolic impairment as defined by lvef≤35% by any current standard technique (echocardiogram, multiple gated acquisition scan, or mri) within 2 months; * able and willing to comply with all pre-, post- and follow-up testing, and requirements; * use of maximum tolerated doses of ace inhibitors (or angiotensin ii receptor blockers if intolerant of ace) and beta blockers and mra as per esc guidelines; * person affiliated to or beneficiary of a social security plan * person informed about study organization and having signed the informed consent exclusion criteria: * history of cardiac arrest or sustained vt or vf unless within 48 hours of an acute myocardial infarction; * standard contraindications for cardiac lge-mri; * hypersensitivity to gadolinium-based contrast agent; * currently implanted permanent pacemaker and/or icd; * patient refusal of icd/ilr implantation; * currently implanted permanent pacemaker and/or icd; * clinical indication for or cardiac resynchronization therapy (crt); * severe renal insufficiency defined by a glomerular filtration rate (gfr) \< 30 ml/min/1.73m²; * recent ptca (within 30 days) or cabg (within 90 days); * baseline nyha functional class iv; * contraindication for icd implantation according to current guidelines; * woman of childbearing age without effective contraception; * person referred in articles l.1121-5, l. 1121-7 and l.1121-8 of the french public health code.

Keywords: myocardial infarction
safety and efficacy of methylphenidate in children with attention-deficit hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this study evaluated the safety and clinical effect of treatment with methylphenidate under different breakfast conditions (minimal breakfast versus standard continental breakfast) in children with attention-deficit hyperactivity disorder (adhd).


Eligibility criteria:
inclusion criteria: * children aged 6-12 * diagnosis of attention-deficit hyperactivity disorder (adhd) * current medication with either 20 mg or 40 mg immediate release methylphenidate exclusion criteria: * concomitant psychiatric disorders requiring pharmacological treatment * concomitant severe somatic disorders * eating disorders * addiction disorders * very high or low body weight according to age * known hypersensitivity to methylphenidate * contraindications for methylphenidate other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: adhd methylphenidate children food effect attention-deficit hyperactivity disorder (adhd) in children
web based therapist tutorial on prolonged grief

Conditions: Prolonged Grief Disorder

Summary: death of a loved one is a difficult life experience. about 1 in 10 bereaved people are strongly affected by the loss and grieve intensely for a long time. as a result of the covid-19 pandemic, more people may struggle with grief. the investigators have developed and tested a talk therapy for prolonged grief. the investigators have developed an online grief training for clinicians. the investigators will test if clinicians benefit from the online training and if they find it helpful and engaging. the investigators will recruit 30 mental health professionals as trainees to undergo the training. the mental health professionals will complete questionnaires before and after training to determine how much they learned and how much they liked the training.

the investigators developed a short-term, manualized prolonged grief disorder therapy (pgdt), originally known as complicated grief treatment and found it efficacious in three large national institute of mental health (nimh) sponsored randomized controlled trials. facilitating access to training in empirically based treatments has been identified as a national priority by both mental health professional organizations and nimh. one way to help disseminate therapist training on ebt of prolonged grief disorder (pgd) is through the use of new technologies. the investigators recently developed an online therapist training program in pgdt and a patient facing therapist-assisted web-based form of pgdt. the investigators are now looking to evaluate the acceptability and effectiveness of each of these online tools in pilot studies. the tutorial contains 10 modules, each about 20-40 minutes long with information needed for effective delivery of pgdt. participants will be encouraged to space out the tutorial vs. taking it in a few long sessions, to facilitate knowledge retention. a post-test will be given immediately after completing each module, as testing done closer to when the material was learned also improves retention. participants will be encouraged to complete the tutorial within 5 weeks (about one hour or two modules per week). consistent with continuing education guidelines, successful completion will require an overall score of 80% on post-tests. participants would need to retake the module until a passing score is obtained. interactive patient scenarios will be integrated into the tutorial at strategic points, in order to integrate conceptual and applied knowledge. all participants will be asked to evaluate whether the stated learning goals of each module were met and complete user satisfaction questionnaires on both the technical aspects of the on-line tutorial (using the system usability scale), and the clinical content (using the user satisfaction questionnaire). participants will have access to the tutorial indefinitely, in order to provide a resource that they can refer back to as they begin to use these skills with patients.

Eligibility criteria:
inclusion criteria: * mental health professional exclusion criteria: * student or employee of columbia university

Keywords: grief therapy training
validation of esophageal variceal grading: a comparative study of upper gastrointestinal (gi) endoscopy and capsule endoscopy

Conditions: Esophageal and Gastric Varices

Summary: the purpose of this study is to develop a grading system for esophageal varices using capsule endoscopy in patients with portal hypertension and cirrhosis.

up to 35% of patients with cirrhosis will develop esophageal varices, which carry with them a 1-year and 3-year bleeding rate of 33% and 41%, respectively. screening for varices with a video endoscopy is limited by its cost, patient compliance, and the risks of sedating a patient with portal hypertension. capsule endoscopy is a novel method that may reduce the costs and increase compliance for screening. the investigators propose to screen 100 consecutive patients with advanced cirrhosis for esophageal varices. a capsule endoscopy and video endoscopy will be done on the same day. the varices seen on video endoscopy will be graded using a standard grading scale. both capsule and video endoscopy images will be assessed in a blinded fashion by 4 independent investigators. finally, the video endoscopic images will be compared to capsule endoscopy to develop a capsule endoscopy grading system that corresponds to video endoscopy. the primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy. secondary endpoints of the study include sensitivity, specificity, inter- and intraobserver variation of variceal grading using capsule endoscopy; patient acceptance as assessed on a visual analogue scale; and a cost comparison (facility fees + professional fees) of the two screening methods.

Eligibility criteria:
inclusion criteria: * advanced cirrhosis with portal hypertension based on imaging, clinical suspicion, or liver biopsy * age greater than or equal to 18 years old * able to give consent exclusion criteria: * current implantable cardioverter-defibrillators or pacemaker in place * suspected intestinal obstruction * esophageal swallowing disorder * esophageal stenosis * age less than 18 years old * pregnancy * known zenker's diverticulum * patients with previous endoscopic or surgical esophageal treatment

Keywords: esophageal varices gastric varices capsule endoscopy portal hypertension cirrhosis gastrointestinal hemorrhage
investigating the role of the polyol pathway in the central nervous system production of fructose

Conditions: Hyperglycaemia (Diabetic)

Summary: to investigate whether longer-term improvement of glycemic control in poorly controlled diabetes patients with a 12-week intensified insulin treatment regimen will lead to decreased polyol pathway activity.

polyol pathway activity will decrease in diabetic individuals who undergo intensification of their insulin treatment regimens as reflected by lower baseline brain intracellular fructose levels and higher intracellular glutathione levels. furthermore, following longer-term improved glycemic control, patients may also have down-regulation of the pathway as reflected by decreased production of intracellular fructose in response to hyperglycemic clamp.

Eligibility criteria:
inclusion criteria: * 15 type 2 dm subjects with hba1c \> 7.5% * 15 type 1 dm subjects with hba1c \> 7.5% * age 18-60 * bmi ≥18 kg/m2 * weight ≤ 285 pounds exclusion criteria: * creatinine \> 1.5 mg/dl, hgb \ 2.5 x uln, * untreated thyroid disease, * uncontrolled hypertension, * known neurological disorders, * untreated psychiatric disorders, * malignancy, * bleeding disorders, * current or recent steroid use in last 3 months, * illicit drug use; * for women: pregnancy, actively seeking pregnancy, or breastfeeding; inability to enter * mri/mrs
rapid renal sympathetic denervation for resistant hypertension ii

Conditions: Resistant Hypertension; Uncontrolled Hypertension; Renal Artery Ablation

Summary: this is a global, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation with the oneshot renal denervation system in patients with uncontrolled hypertension.


Eligibility criteria:
inclusion criteria: * individual has a systolic blood pressure ≥ 160 mmhg based on an average of three office blood pressure readings. * stable drug regimen including three or more anti-hypertensive medications including a diuretic exclusion criteria: * renal anatomy unsuitable for treatment * presence of hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous * patient has type i diabetes * has scheduled or planned surgery within the next 6 months * individual is pregnant nursing or plans to be pregnant

Keywords: resistant hypertension uncontrolled hypertension renal artery ablation
side specific withdrawal times for colonoscopy: impact on adenoma detection in the proximal and distal colon

Conditions: Colon Adenoma

Summary: adenoma detection in the main goal of screening colonoscopy. in order to detect adenomas it is mandatory to spend a long enough time investigating the colonic mucosa. a minimum observation time of 6 minutes has been proposed as a quality criterion for screening colonoscopy. however, different locations of the colon (proximal, distal) may require specific observation time periods. the colon can be divided into a proximal (right) and distal (left) part. until now, it is unclear whether observation time has a significant impact on adenoma detection in both parts of the colon. the aim of this study therefore is to conduct a trial in which side-specific observation times and adenoma detection rates are measured in order to investigate this correlation in particular for the right colon.


Eligibility criteria:
inclusion criteria: * indication for colonoscopy * age ≥ 40 years exclusion criteria: * american society of anesthesiologists class iv or higher * pregnant women * indication for colonoscopy: inflammatory bowel disease * indication for colonoscopy: polyposis syndrome * indication for colonoscopy: emergency colonoscopy e.g. acute bleeding * contraindication for polyp resection e.g. patients on warfarin

Keywords: adenoma colonoscopy withdrawal proximal observation time
a trial to improve quality of life in people with cirrhosis

Conditions: Cirrhosis

Summary: this trial is being completed to evaluate whether a crystallized form of lactulose (kristalose) will improve quality of life, sleep and cognitive function in patients with cirrhosis that have not been diagnosed with hepatic encephalopathy (he), but report reduced quality of life.


Eligibility criteria:
inclusion criteria: * diagnosis of cirrhosis - must meet one of the following criteria: 1. liver biopsy, or 2. history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, or 3. 2 of the following 4 criteria: 1. ultrasound, computed tomography (ct) or magnetic resonance imaging (mri) findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites) 2. fibroscan liver stiffness score \>13 kilopascal (kpa) 3. laboratory testing: aspartate aminotransferase (ast)/platelet ratio index (apri) \>2.0 4. ct, mri or esophagogastroduodenoscopy (egd) showing presence of esophageal varices exclusion criteria: * non-english speaking * pregnancy (self-reported) * unable or unwilling to provide consent * history of liver transplant * disorientation at the time of enrollment, dementia, or treated memory disorder * history of prior lactulose use or he within 6 months * metastatic solid malignancy or blood malignancy * hemoglobin a1c \> 12 (within past year)

Keywords: hepatic encephalopathy liver disease cirrhosis and portal hypertension