Kornimate/medical-research-clean huggingface dataset:
ruxolitinib vs allogeneic sct for patients with myelofibrosis according to donor availability

Conditions: Bone Marrow Fibrosis

Summary: the present study will be a multicenter, prospective phase ii-study comparing efficacy of allogeneic sct for patients with myelofibrosis who have a suitable stem cell donor after a 3 months ruxolitinib induction therapy with patients who lack a suitable stem cell donor and will continue to receive ruxolitinib.

this study is a multicenter, prospective phase ii-study compares efficacy of allogeneic sct for patients with myelofibrosis who have a suitable stem cell donor after a 3 months ruxolitinib induction therapy with patients who lack a suitable stem cell donor and will continue to receive ruxolitinib. in this study will further assess and compare the safety and efficacy of study treatments/ induction therapy in both study arms on spleen reduction, improvement of constitutional symptoms, qol, toxicity, fibrosis regression, development of gvhd as well as chimerism, engraftment, relapse incidence, disease related mortality, outcome and overall survival.

Eligibility criteria:
inclusion criteria: 1. symptomatic primary myelofibrosis or myelofibrosis post polycythaemia vera or essential thrombocythemia stage intermediate 2- or high-risk according to ipss or dipss \[46\] or intermediate 1-risk with high risk cytogenetics, other than normal karyotype, sole del 20q, del 13q, or sole+9, or transfusion-dependency 2. patients age: 18 - 70 years at time of inclusion (female and male) 3. patients understand and voluntarily sign an informed consent form 4. platelet count ≥ 50 x 109/l 5. no prior ruxolitinib treatment 6. ecog ≤ 2 exclusion criteria: 1. severe renal, hepatic, pulmonary or cardiac disease, such as: * total bilirubin, sgpt or sgot \> 3 times upper the normal level * left ventricular ejection fraction \< 30 % * creatinine clearance \< 30 ml/min * dlco \< 35 % and/or receiving supplementary continuous oxygen 2. positive serology for hiv 3. pregnant or lactating women (positive serum pregnancy test) 4. age \< 18 and ≥ 71 years. 5. uncontrolled invasive fungal infection at time of screening (baseline) 6. serious psychiatric or psychological disorders 7. participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment 8. transformation to aml

Keywords: myelofibrosis, myeloproliferative disease
clinical and neurobiological effects of cannabis dependence in young adults

Conditions: Cannabis Dependence; Cannabis Withdrawal

Summary: the purpose of this study is to find out more about cognitive functioning in people who are cannabis dependent, relative to people who do not use cannabis, and how their brains process information after one month of not using cannabis. an additional goal is to characterize the severity of cannabis dependence using precipitated and naturalistic withdrawal with a double blind, placebo controlled, single administration of rimonabant. research assessments occur bi-weekly throughout this 28 day study.


Eligibility criteria:
cannabis dependent subjects: inclusion criteria: * males or females 21-30 years of age * meets diagnostic and statistical manual (dsm-iv) diagnosis of cannabis dependence * willing to be abstinent for 28 days during study * smokes \< 10 cigarettes per day * drinks \< 1 (female) or \< 2 (male) per day exclusion criteria: * active suicide ideation * meets dsm-iv diagnosis for dependence on other substances other than cannabis * significant medical disorders * pregnant women * meets dsm-iv diagnosis for a major axis i disorder other than cannabis dependence * currently taking psychoactive medication

Keywords: cannabis dependence marijuana dependence cannabis withdrawal rimonabant cannabinoid receptor type 1 (cb1) inverse agonist neuropsychology functional magnetic resonance imaging (fmri) endocannabinoids cortisol
safety, tolerability, and pharmacokinetics of id119031166m with the exploration of pharmacodynamic effects

Conditions: Healthy Participants

Summary: this study will evaluate safety, tolerability, and pharmacokinetics (pk) of id119031166m with the exploration of pharmacodynamic (pd) effects in healthy participants.

this is a phase 1, randomized, double-blind, placebo-controlled, sequential single/repeated-dose study. this study is a dose-escalation study with healthy participants in single ascending dose (sad) including food-effect and multiple ascending dose (mad) cohorts to determine the highest allowable dose (had).

Eligibility criteria:
inclusion criteria: * must be caucasian (white american of european or latin american descent). * healthy participants of japanese origin are allowed up to 50% in each mad cohort. * body mass index (bmi) within the range of 18.5 to 30 kg/m\^2 (inclusive) at the time of screening. * no congenital or chronic diseases that require treatment and without pathologic symptoms or signs on medical examinations. * participants with normal renal function. * women are eligible to participate if not pregnant, not breastfeeding. male subjects should be willing to use 'highly effective' or 'applicable' contraceptive methods. exclusion criteria: * currently have an acute disease with active symptoms. * history of melanoma or other skin issues (including, but not limited to pre-cancerous areas, atopic dermatitis, psoriasis, rosacea, excessive moles etc.). * history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal, or cardiovascular disease and/or arrhythmias. * history of clinically significant hypersensitivity reaction to any drugs or additives. * history of any gastrointestinal disease. * history of substance use disorder including history of drug abuse disorder or history of alcohol use disorder, or tobacco use disorder or excessive caffeine intake. * evidence of moderate or excessive alcohol consumption. * tested positive in viral serology tests (hepatitis b virus \[hbv\], hepatitis c virus \[hcv\], and human immunodeficiency virus \[hiv\]). * known family history or known presence of long qt syndrome. * a history of hypokalemia. * use of concomitant medicines that prolong qt/qtc (qt interval corrected for heart rate). * history of active viral hepatitis (hepatitis a, b, c, and e), or autoimmune hepatitis. * history of multiple endocrine neoplasia type 2. * solid organ transplantation, except corneal transplants. * history or presence of neutropenia which is defined as absolute neutrophil count (anc) \< 1.5 at screening and admission. * participants with a microalbuminuria. * hemoglobin levels below 12.0 g/dl at screening or baseline. * white blood cell levels below 3.5 × 109/l at screening or baseline. * platelet count \ 1.5, albumin \< 3.5 g/dl

Keywords: first-in-human (fih) single ascending doses (sad) multiple ascending doses (mad) farnesoid x receptor (fxr) agonist noncirrhotic non-alcoholic steatohepatitis (nash) liver fibrosis
characterization and durability of covid-19 vaccine induced immune responses in healthcare/frontline workers

Conditions: Covid19

Summary: rationale: early in the covid-19 pandemic, it was unclear whether and how individuals and populations would develop protective and enduring immunity against sars-cov-2, either after infection or vaccination. it is still not clear what role might immune cellular responses play in the development of immunity to sars-cov-2 infection and what are the implications for vaccines? as t cells recognise and respond to viral antigens they produce many protective reactions and effector molecules. one such molecule is the cytokine interferon γ, secreted by cd4+ and cd8+ t cells and their memory cells. this can be measured means of documenting specific t cell responses to viral antigens. published studies offered a strong evidence that t cell immune responses are sustained, even in the face of declining or undetectable antibodies, implying that some immunity persists. the evidence from new studies, interim results from phase iii vaccine trials, and previous data from phase i and phase ii trials support the notion that memory t cell responses to the vaccines, along with b cell antibody responses, should provide good and possibly enduring immunity to sars-cov-2. we propose to describe and characterize the humoral, innate and long-term adaptive immune responses and the neutralization potential generated by covid-19 vaccination (covaxin, covishield) among healthcare and frontline workers.

study objectives i. to estimate the neutralizing antibodies titre against sars cov-2 by vaccine type. ii. to estimate the proportion of vaccine recipients developing effective antibody response for sars-cov-2 specific igg, igm, and total ige and iga antibodies pre- and post-covid-19 vaccination on day zero, day 28, month 2, 3, 6, 12, 18 and 24 by vaccine type. iii. to identify and characterize the immune biomarkers for long term innate and adaptive immune response by vaccine type. iv. to estimate the ratio of immune biomarker levels between pre- and post- covid-19 vaccination at days 28, month 2, 3, 6, 12, 18 and 24 by vaccine type

Eligibility criteria:
inclusion criteria: * adults aged 18-60 years * should have been vaccinated with either covaxin or covishield * willing to provide written informed consent exclusion criteria: * participants will be ineligible if they are not vaccinated for either covaxin or covishield vaccine * not willing to provide written informed consent
comparison of 2 doses of mannitol on post traumatic intracranial hypertension and cerebral monitoring

Conditions: Traumatic Brain Injury; Intracranial Hypertension

Summary: will an increase of the dose of mannitol improve the effects on neuromonitoring in patients suffering intracranial hypertension following traumatic brain injury?

traumatic brain injury intracranial hypertension 0,4 g/ kg vs 0,8 g/ kg (randomized) on 20 minutes monitoring: icp, transcranial doppler, brain po2, map, hr, diuresis, biology duration: 2 hours

Eligibility criteria:
inclusion criteria: * adults * severe traumatic brain injury * intracranial hypertension requiring mannitol administration exclusion criteria: * impeding neurosurgery * hemodynamic or respiratory severe failure
phase 2b study of alto-100 in mdd

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to determine efficacy differences between alto-100 and placebo, used either as monotherapy or adjunctively to an antidepressant, related to patient characteristics.


Eligibility criteria:
inclusion criteria: * have a diagnosis of moderate to severe major depressive disorder (mdd) * at baseline, either not taking an antidepressant medication, or currently taking a single ssri, snri, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks * willing to comply with all study assessments and procedures * must not be pregnant or breastfeeding at time of enrollment or throughout study exclusion criteria: * evidence of unstable medical condition * diagnosed bipolar disorder, psychotic disorder, or dementia * current moderate or severe substance use disorder * has a history of hypersensitivity or allergic reaction to alto-100 or any of its components/excipients * concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
co-feedback action of growth hormone, pp and pyy on ghrelin in bulimia

Conditions: Eating Disorder; Bulimia Nervosa

Summary: this study evaluates the addition of acipimox or placebo to exercise on growth hormone release and ghrelin secretion in bulimic patients and in healthy women. two groups of participants will receive acipimox together with exercise versus identical placebo with exercise.

acipimox and exercise each increase growth hormone release, but they do so by different mechanisms. acipimox is an anti-lipolytic drug and increases growth hormone release by decreasing free fatty acids levels and that acipimox may exert to a negative feedback of growth hormone on ghrelin. physical exercise is a potent physiological stimulus for growth hormone release. as ghrelin has a stimulatory effect on growth hormone secretion, growth hormone may inhibit circulating ghrelin levels via a feedback loop. growth hormone stimulates lipolysis and resultant free fatty acids may suppress ghrelin secretion.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of bulimia nervosa * body mass index (bmi) between 18 and 23 kg/m2 exclusion criteria: * history of heart disease * history of bleeding disorders * subjects with diabetes type 1 or 2, hypo- or hyperthyroidism * subjects with hepatogastroenteric disease * pregnant, trying to become pregnant or breast feeding * patients with other psychiatric diseases

Keywords: neuropeptides microdialysis
lamotrigine cognitive function study in adult untreated epilepsies

Conditions: Epilepsy

Summary: the purpose of this study is to compare the effect of anti-epileptic drugs' (aeds) long-term treatment on cognitive function. this study is an open-label, randomized, multicenter comparative trial of lamotrigine versus carbamazepine. the planned enrollment is 100 patients.


Eligibility criteria:
inclusion criteria: * age : 16\~60 * seizure type was defined by mri etc. * had more than 2 unprovoked seizures or 1 seizure with clear evidence for epilepsy (ex. positive in eeg or brain imaging) * need aed therapy and no aed medication for previous 1 year (exclude emergency medication for less than 2 weeks, baseline 4 weeks before) * is not pregnant by pregnancy test and is using contraceptive method * can report seizure diary by him/herself or his/her sick nurse * agreed to trial by written consent exclusion criteria: * follow-up loss * canceled agreement * added other medication due to aggravated disease in 24 weeks * diagnosed as ige * has progressive cns disease by mri or eeg * has serious systemic or psychological disease * under iq 70 * baseline lad data abnormality: creatinine 2.0mg/dl or got/gpt 2 times higher than normal * abuse experience on alcohol or drugs * has experience on serious adverse event of any drug * previous experience on lamotrigine or carbamazepine * not suitable patients by investigator (uncooperative) * other reason which may interrupt the trial

Keywords: epilepsy lamotrigine cognitive function
a study to evaluate the efficacy and safety of quinapril or quinapril plus hydrochlorothiazide in patients with mild to moderate hypertension

Conditions: Hypertension

Summary: the purpose of this study is to determine the response rate for the therapeutic goal (diastolic blood pressure (bp) less than 90 mmhg and systolic bp less than 140 mmhg) at week 6 for quinapril 20 mg and at week 12 for quinapril 20 mg, quinapril 40 mg, and quinapril 20 mg plus hydrochlorothiazide 12.5 mg; and to determine the mean decrease in diastolic and systolic bp measurements and the change in heart rate at week 6 and week 12 compared with baseline.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of mild to moderate primary hypertension ("joint national committee on prevention, detection, evaluation, and treatment of high blood pressure, 6th report" stage i or ii) * sitting diastolic blood pressure between 90 mmhg and 109 mmhg and systolic blood pressure between 140 mmhg and 179 mmhg at the end of the no-treatment run-in period exclusion criteria: * subjects with secondary hypertension * subjects with serious cardiac disease (including myocardial infarction in the last 3 months or decompensated heart failure) * subjects who do not accept to stop using any other antihypertensive treatment during the run-in period and the treatment period of the study
extracorporeal shock wave therapy on osteoblast-like cells in- vitro study

Conditions: Osteosarcoma

Summary: the idea of treating different deformities or diseases in the maxillofacial region with extracorporeal shockwave therapy (eswt) has recently become popular. it has been widely used in medical practice for the management of urolithiasis, cholelithiasis and in haead and neck region for sialolithiasis. the present study 'extracorporeal shock wave therapy on osteoblast-like cells in-vitro study' will be done to explore and evaluate the effect of shockwaves. further, osteoblast-like cells will be assessed for cell - cell interaction and cell viability. it will be assessed using a scratch assay, mtt assay and atp analysis.

introduction: extracorporeal shockwave therapy (eswt) has recently become popular. shockwave has been widely used in medical practice for the management of urolithiasis, cholelithiasis and in haead and neck region for sialolithiasis. aim: this study 'extracorporeal shock wave therapy on osteoblast-like cells in-vitro study' will be done to explore and evaluate the effect of shockwaves. further, osteoblast-like cells will be assessed for cell - cell interaction and cell viability. methodology: in this in-vitro study, 20 osteoblast - like cells will be included. 10 samples to be considered for control group and the remaining 10 samples considered as test group. extracorporeal shockwave will be applied to the test samples. they will be further analysed using wound scratch assay which is used to assess cell proliferative rate and scratch closure through live imaging. mtt assay and atp assay used to determine cell viability after exposure to shockwaves. the cell migration and cell viability after exposure to shockwaves will determine its effects on osteoblast-like cells.

Eligibility criteria:
inclusion criteria: * cell cultures with a confluency of 70%-80% exclusion criteria: * contaminated cell cultures

Keywords: eswt cell proliferation cell viability
low nicotine content cigarettes in vulnerable populations: women of reproductive age

Conditions: Tobacco Use Disorder

Summary: despite marked reductions in cigarette smoking in the general population, smoking among economically disadvantaged women has increased. smoking among women of reproductive age is a particular concern because in addition to the usual health risks, there are additional risks should they become pregnant. a national nicotine reduction policy for cigarettes has considerable potential to reduce tobacco use, dependence, and improve health in this population. controlled trials in general population samples have demonstrated that reducing the nicotine content in cigarettes can reduce cigarettes per day (cpd), dependence severity, and tobacco toxicant exposure. the goal of the proposed trial is to experimentally examine whether increasing the availability and appeal of an alternative, non-combusted source of nicotine (e-cigarettes) enhances the effect of altering the nicotine in cigarettes in non-pregnant female cigarette smokers of childbearing age. additionally, investigators will test whether allowing participants to personalize the flavor of the e-liquid alters any moderating effects their availability may have on tobacco cigarette smoking. daily smokers who are female, aged 21-44 years, and have a maximum educational attainment of graduating high school, will be recruited at johns hopkins university and the university of vermont. investigators will study two research cigarettes referred to here as research cigarettes 1 (rc1) and research cigarettes 2 (rc2). one will be a normal nicotine content cigarette and the other a reduced nicotine content cigarette. investigators will study two e-cigarette conditions referred to here as e-cigarette condition 1 (ec1) and e-cigarette condition 2 (ec2). both e-cigarette conditions will involve the same commercially available devices and same nicotine-containing e-liquid, but in one condition that e-liquid will be available only in tobacco flavor while in the other the e-liquid will be available in multiple flavors from which participants can choose three based on personal preference. participants will be assigned to one of the following four conditions: (1) rc1 only; (2) rc2 only; (3) rc2 + ec1; (4) rc2 + ec2. participants will be asked to use only their assigned study products for 16 weeks. outcome measures include total cpd, craving, withdrawal, psychiatric symptoms, breath carbon monoxide (co), other biomarkers of tobacco toxicant exposure, and cigarette demand assessed by behavioral economic purchase tasks.


Eligibility criteria:
inclusion criteria: * female * 21 to 44 years old exclusion criteria: * male * under 21 years old * over 44 years old

Keywords: biomarkers of exposure nicotine dependence reduced nicotine cigarettes tobacco withdrawal women health disparities vulnerable populations e-cigarettes
the effect of ganoderma on patients with head-and-neck cancer

Conditions: Head-and-neck Cancer

Summary: to study the effect of ganoderma spores powder capsules on the life quality and immunity status of the patients with head-and-neck cancer after complete treatment (including surgery and / or radiotherapy and/or chemotherapy)

ganoderma is known to modulate immunity and improve health. however, the mechanism is not clear. we hypothesize that patients who have completed standard treatment with/without radiotherapy might require biological modifier such as ganoderma to improve life quality and immunity status. a total of 100 patients are randomized to study and control groups. in study group, ganoderma spores powder capsules are given to the patients for 6 weeks, in control group, only placebos are given during the same period. then the patients in study and control groups are switched, ganoderma spores powder capsules and placebos are given for 6 weeks. the data pertaining to their life quality are collected using quality of life questionnaire after the first 6 weeks and the second 6 weeks. the immunity status is also studied at the same time.

Eligibility criteria:
inclusion criteria: * patients with head-and-neck cancer after complete treatment for at least 3 months (including surgery and/or radiotherapy and/or chemotherapy) exclusion criteria: * patients with head-and-neck cancer under treatment or within 3 months after treatment

Keywords: gandoerma spores powder capsules, head-and-neck cancer.