Kornimate/medical-research-clean huggingface dataset:
intravenous (iv) decitabine and oral bexarotene for acute myelogenous leukemia (aml)

Conditions: Leukemia, Myeloid, Acute

Summary: the main objective is to determine the safety and tolerability of combination decitabine and bexarotene during four cycles of therapy.

the investigators are seeking to study the combination of decitabine and bexarotene. these two agents have each shown efficacy in decreasing leukemic blast counts and restoring normal hematopoiesis via different mechanisms of action and with non-overlapping side-effect profiles. by combining these agents, the investigators hope to improve overall response rates. the investigators further hope to improve platelet and neutrophil counts in an even greater number of patients, thus treating two of the most important sources of morbidity and mortality in this patient population.

Eligibility criteria:
inclusion criteria: * aml with bone marrow blasts ≥ 20%. * relapsed disease after 1 or more lines of prior salvage chemotherapy and any fab-aml, or * diagnosis of aml and age ≥ 60 and not a candidate for cytotoxic chemotherapy and any fab-aml except fab-m3. * performance status ≤ 2. * age ≥ 18 years. exclusion criteria: * peripheral white blood cell count (wbc) \> 10,000/microliter. * total bilirubin \> 1.5 x normal. * ast/alt \> 2.5 x normal. * serum creatinine \> 2 x normal. * fasting serum triglyceride \> 1,000 mg/dl. * active or poorly controlled graft vs host disease (gvhd). * pregnant or nursing. * known cns leukemia. * history of positive hiv serology. * history of positive hepatitis c serology. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congestive heart failure of nyha class 3 or 4, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements. * chemotherapy within 21 days of enrollment. * radiation therapy within 14 days of enrollment.
safety and efficacy study of dur-928 topical solution in subjects with plaque psoriasis

Conditions: Plaque Psoriasis

Summary: this phase 2 study has been designed to determine and compare the safety, tolerability, and efficacy of dur-928 topical solution with that of the vehicle topical solution when applied once daily for approximately four weeks in subjects with plaque psoriasis. subjects will be instructed (randomly assigned) to apply dur-928 solution to a target lesion on one arm and vehicle solution to a target lesion on the opposite arm once daily for up to four weeks. subjects will occlude the treated areas for approximately two hours after each application.


Eligibility criteria:
inclusion criteria: 1. subject is a male or non-pregnant female 18 years of age or older. 2. subject has provided written informed consent. 3. subject has a clinical diagnosis of stable mild to moderate plaque psoriasis for at least two months. 4. females must be post-menopausal, surgically sterile, or use an effective method of birth control. women of childbearing potential (wocbp) must have a negative urine pregnancy test (upt) at visit 2/baseline. 5. males (or their female partner) must agree to use an effective method of birth control throughout the study. 6. subject has two similar contralateral target plaques. 7. subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study. 8. subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of the plaque psoriasis or exposes the subject to an unacceptable risk by study participation. exclusion criteria: 1. subject is pregnant, lactating, or is planning to become pregnant during the study. 2. subject has spontaneously improving or rapidly deteriorating plaque psoriasis. 3. subject has guttate, pustular, erythrodermic, inverse, or other non-plaque forms of psoriasis. 4. subject has psoriasis beyond the two target plaques that, in the investigator's opinion, could not be reasonably managed with only a bland emollient during the study. 5. subject is currently enrolled in an investigational drug or device study. 6. subject has been previously enrolled in this study and treated with test article. other protocol-defined inclusion and exclusion criteria assessed by the study staff may apply.
brain awake surgery using virtual reality headset

Conditions: Brain Tumor; Virtual Reality

Summary: feasibility and tolerance study of virtual reality headset for brain mapping during brain awake surgery.


Eligibility criteria:
inclusion criteria: * unilateral tumor or any type of brain lesion localized at the vicinity of eloquent area exclusion criteria: * emergency * any contra-indication to awake brain surgery

Keywords: virtual reality glioma surgery awake craniotomy brain tumor glioma neurosurgery
ethibond suture vs vessel loop as draining seton for complex anal fistulas

Conditions: Anal Fistula

Summary: drainage seton is usually placed for long-term control of symptoms, and hence it has to be effective in drainage of infection, durable, and comfortable to the patients. the present study assumes that different seton materials would attain different drainage capacities, variable durability and impact on qol. therefore, the study aims to compare two commonly used seton materials; ethibond suture and vessel loop, in the management of caf in terms of effectiveness in draining infection, percent of seton break and its timing, and change in patients' qol as measured by a validated questionnaire.

the use of seton as a surgical therapy for fistulous disease has been first described by hippocrates in 430 bce. since then several authors have used either cutting or drainage seton to treat caf. different materials have been used as seton, including sutures, stainless steel wires, catheters, cables, silicone, and rubber bands. while the main aim of a drainage seton is to simply drain sepsis and control symptoms in the long term, cutting setons are mainly used for eradiation of the fistula pathology by cutting through the fistula tract and anal sphincter muscles, yet at the cost of an increased risk of fecal incontinence (fi). as the purpose of a drainage seton is to provide long-term, durable drainage of perineal sepsis and control of symptoms, namely discharge, the seton material can have an impact on its function and durability. a review of the variations in seton types and materials showed that the success rates of suture seton (silk, prolene or nylon suture) are higher than those of penrose drains and catheters. however, there is a paucity of data on the impact of the seton material on the durability of seton and quality of life (qol) drainage seton is usually placed for long-term control of symptoms, and hence it has to be effective in drainage of infection, durable, and comfortable to the patients. the present study assumes that different seton materials would attain different drainage capacities, variable durability, and impact on qol. therefore, the study aims to compare two commonly used seton materials; ethibond suture and vessel loop, in the management of caf in terms of effectiveness in draining infection, percent of seton break and its timing, and change in patients' qol as measured by a validated questionnaire.

Eligibility criteria:
inclusion criteria: * adult patients aged 18 years or older of either sex who present with caf will be included. both cryptoglandular fistulas and fistulas secondary to inflammatory bowel disease (ibd) exclusion criteria: * simple anal fistulas * fistulas secondary to malignancy or irradiation therapy * pregnant women * patients with pre-existing setons
chronic low back pain rehabilitation in primary care: an rct

Conditions: Low Back Pain; Chronic Pain; Musculoskeletal Pain

Summary: the aim of this study is to evaluate the effectiveness and cost-effectiveness of a new primary care intervention "back on track" as compared to usual primary care in patients with non-specific chronic low back pain in which disability levels are moderate and the role of psychosocial factors to this disability is at maximum low (classified as wpn2).


Eligibility criteria:
inclusion criteria: * chronic low back pain; defined as pain between scapulae and gluteal region, whether or not with radiation towards one or both legs, present for at least three months. * presence of contributing social and psychological factors, however not complex (wpn2 classification) * age between 18 and 65 year * sufficient knowledge of the dutch language * acceptance towards the biopsychosocial approach instead of biomedical approach exclusion criteria: * chronic low back pain attributable to e.g. infection, tumour, osteoporosis, fracture, structural deformation, inflammatory process, radicular syndrome or cauda equina syndrome * pregnancy * any suspicion of an (underlying) psychiatric disease, for which psychiatric treatment is better suited, according to the expert opinion of the consultant in rehabilitation medicine.

Keywords: cognitive behavioral therapy primary health care physical therapy
efficacy and safety of fermented ginseng powder on liver function

Conditions: Fatty Liver, Nonalcoholic

Summary: this study was conducted to investigate the effects of daily supplementation of fermented ginseng powder on improvement of liver function.

the investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of fermented ginseng powder on improvement of liver function. the investigators measured alt(alanine transaminase) profiles, liver function index, fatty liver grade, lipid metabolism index, total antioxidant capacity, imflammation index, and multidimensional fatigue scale.

Eligibility criteria:
inclusion criteria: * age 19-70 years with alt 35-105 iu/l exclusion criteria: * under antipsychotic drugs therapy within past 2 months * history of alcohol or substance abuse * participation in any other clinical trials within past 2 months * laboratory test by show the following results * serum creatinine \> 2.0 mg/dl * pregnancy or breast feeding etc.

Keywords: ginseng powder fatty liver clinical trial
exercise therapy for femoroacetabular impingement syndrome

Conditions: Femoroacetabular Impingement Syndrome

Summary: the aim of the clinical trial is to investigate the characteristics of patients, who respond vs. not respond to exercise therapy for the nonsurgical management of femoroacetabular impingement syndrome (fais).

patients with a diagnosis of fais will be recruited from 2 clinical centers and will receive exercise therapy (study intervention). exercise therapy is a semi-standardized intervention and will last 12 weeks (3 months). hip pain, function and quality of life will be assessed using a patient-reported questionnaire at baseline, 3, 6 and 12 months' follow-up. hip joint contact pressure will be evaluated using motion analysis and modelling at baseline, 3 and 12 months' follow-up. hip morphology will be evaluated using imaging at baseline and hip surgery rate will be evaluated at 6 and 12 months' follow-up.

Eligibility criteria:
inclusion criteria: * age: 18 to 50 years; * diagnosis of fais; * availability of magnetic resonance arthrography and anteroposterior pelvic radiography of the involved hip; * signed informed consent form. exclusion criteria: * previous hip surgery; * any surgery on the lower extremities in the last 6 months; * hip dysplasia: lateral center edge angle \<25°; * hip osteoarthritis: tönnis grade \>1; * bmi: \>35 kg/m2; * significant cardiopulmonary diseases.
clinical trial to test the phenolization in sacrococcygeal pilonidal disease

Conditions: Sacrococcygeal Fistula; Pilonidal Sinus; Pilonidal Disease; Pilonidal Disease of Natal Cleft

Summary: randomized clinical trial to test the efficacy and safety of phenolization in uncomplicated sacrococcygeal pilonidal disease

this is a single center randomized controlled clinical trial consisting in 2 treatment groups. all patients admitted at university hospital of tarragona joan xxiii with sacrococcygeal pilonidal disease were likely to enter in the study. all patients with uncomplicated sacrococcygeal disease, localized in the midline and with only 1 fistulous orifice. when the patients met the criteria and after consenting the admission in the study, they were included and were operated. the patients were randomly assigned to the phenolization group or conventional-surgery group. a unique anesthetic and surgical protocol were established for both groups. patients in the phenolization group underwent curettage with an otorhinolaryngology spatula and endocavitary phenol with an abocath needle until complete coagulation of the cyst. patients in the conventional-surgery group were referred to conventional surgery consisting of complete excision of the cyst and closure by second intention. both groups were managed without admission and discharged within a few hours if they met aldrete criteria. they were followed daily by the home hospitalization team the main endpoint was short or medium-term recurrence of sacrococcygeal disease. the number of recurrences per group and the time from surgery to recurrence were assessed. secondary endpoints included degree of satisfaction and sick leave

Eligibility criteria:
inclusion criteria: * patients over 18 years old * asa (american society anesthesiologists) less than or equal to 3 * patients who live accompanied in a home at a maximum distance of 30 minutes from the hospital * adequate cognitive capacity exclusion criteria: * pregnancy or breastfeeding * complicated sacrococcygeal pilonidal disease * non-randomized surgical management
cromoglicate in mastocytosis

Conditions: Mastocytosis

Summary: the purpose of this exploratory study is to investigate the clinical efficacy of study drug (lp0074) in the treatment of mastocytosis. the trial will be performed as a left/right comparison study in male/female subjects with mastocytosis, in a prospective, double-blinded, randomised, single centre setting.


Eligibility criteria:
inclusion criteria: * signed informed consent has been obtained * chronic stable symptomatic maculopapulous cutaneous mastocytosis or indolent systemic mastocytosis with skin involvement and a positive darier's sign * age between 18 and 70 years * either sex * any race or ethnicity * attending hospital outpatient clinic or the private practice of a dermatologist. exclusion criteria: * the presence of autoimmune and infectious disease including aggressive systemic mastocytosis * medical history or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia * medical history or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy, hyper/hypokalemia * evidence of severe renal dysfunction (creatinine \> 1,5 times upper reference value) * evidence of significant hepatic disease (liver enzymes \> 2 times upper reference value) * presence of active cancer which requires chemotherapy or radiation therapy * commitment to an institution in terms of § 40 abs. 1 s. 3 nr. 4 amg * intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study * intake of oral corticosteroids within 14 days prior to randomisation * use of depot corticosteroids or chronic systemic corticosteroids within 21 days prior to randomisation * radiation therapy of target areas including uv therapy within 4 weeks prior to randomisation * confounding other dermatological diseases or conditions that can affect the symptoms of the target areas * known or suspected hypersensitivity to component(s) of investigational products. * current participation in any other interventional clinical trial. * subjects who have received treatment with any nonmarketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the last 4 weeks or 5 half-lives (whichever is longer) prior to randomisation * previously randomised in this clinical trial * in the opinion of the investigator, the subject is unlikely to comply with the clinical study protocol (e.g. alcoholism, drug dependency or psychotic state). * females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial or are breast feeding. * females of child-bearing potential with positive pregnancy test at visit 1. * subjects (or their partner) not using an adequate method of contraception (according to national requirements, as applicable)
efficacy and safety of hl-040xc in essential hypertension and hyperlipidemia

Conditions: Essential Hypertension; Hyperlipidemia

Summary: the purpose of this study is to evaluate efficacy and safety of hl-040xc in patients with essential hypertension and hyperlipidemia


Eligibility criteria:
inclusion criteria: * aged between 18 and 80 years * history of essential hypertension and hyperlipidemia * able to sign informed consent exclusion criteria: * at screening, sbp ≥ 180mmhg or dbp ≥ 110mmhg or ldl-c \> 250mg/dl or tg ≥ 400mg/dl * has a history of hypersensitivity to angiotensin ⅱ receptor blocker or hmg-coa reductase inhibitor or component of this drug

Keywords: atorvastatin losartan essential hypertension hyperlipidemia
day-night rhythm in muscle metabolism of prediabetics

Conditions: Diabetes Mellitus, Type 2; Insulin Resistance

Summary: this study evaluates the existence of a day-night rhythm in skeletal muscle energy metabolism in prediabetic subjects. subjects will stay at the research facility for 44 hours with a standardized living protocol during which several measurements of skeletal muscle and whole body energy metabolism will be performed.

recent evidence from both observational and experimental studies indicates that disobedience of a normal day-night rhythm negatively influences metabolic and cardiovascular health, possibly leading to obesity and type 2 diabetes mellitus (t2dm). an important hallmark of obesity and t2dm is a decreased skeletal muscle mitochondrial function. interestingly, recent research indicates that also skeletal muscle mitochondrial function is under the influence of a day-night rhythm. in this study, the presence of a day-night rhythm in skeletal muscle energy metabolism (in particular mitochondrial function) of overweight prediabetic participants will be investigated. during this study, subjects will stay at the research unit for 44 hours, with standardized meals and sleeping time. five muscle biopsies (v. lateralis) and frequent blood draws will be taken. in addition, indirect calorimetry measurements will be performed.

Eligibility criteria:
inclusion criteria: * caucasian * healthy (as determined by dependent physician) * overweight: bmi 25 - 35 kg/m2 * prediabetic based on one or a combination of the following criteria: * impaired glucose tolerance (igt): plasma glucose values ≥ 7.8 mmol/l and ≤ 11.1 mmol/l 120 minutes after glucose drink consumption during ogtt in screening. * impaired fasting glucose (ifg): fasting plasma glucose ≥ 6.1 mmol/l and ≤ 6.9 mmol/l. * insulin resistance: glucose clearance rate ≤ 360ml/kg/min, as determined using the ogis120 model. * hba1c of 5.7-6.4%. * regular sleeping time (normally 7 - 9h daily) * stable dietary habits: no weight gain or loss \> 3kg in the last three months. exclusion criteria: * use of anticoagulants * previously diagnosed with type 2 diabetes * current alcohol consumption \> 20 grams alcohol/day * extreme early bird or extreme night person (score ≤ 30 or ≥ 70 on meq-sa questionnaire) * heavily varying sleep-wake rhythm * nightshift work during last 3 months * travel across \> 1 time zone in the last 3 months * significant food allergies/intolerance (seriously hampering study meals) * using \> 400mg caffeine daily (more than 4 coffee or energy drink) * smoking

Keywords: circadian rhythm
acute heart failure with reduced ejection fraction - congestion discharge evaluation

Conditions: Acute Heart Failure

Summary: the ahf-code reduced study is a prospective, non-randomized, monocenter study performed in patients with heart failure with reduced ejection fraction admitted for worsening heart failure. the main objective of the ahf-code study is to identify congestion markers (clinical, biological and ultrasound) at the end of hospitalization for acute heart failure that are associated with the risk of all cause death or rehospitalization for acute heart failure within 3 months of hospital discharge.


Eligibility criteria:
inclusion criteria: * patients hospitalised for acute heart failure. * patients with reduced ejection fraction (ejection fraction \<40%) or (40% ≤ ejection fraction \< 50) * patients considered clinically discharging from hospitalisation for acute heart failure. * age ≥18 years * patients having received complete information regarding the study design and having signed their informed consent form. * patient affiliated to or beneficiary of a social security scheme. exclusion criteria: * comorbidity for which the life expectancy is ≤ 3 months * dialysis patient (peritoneal dialysis or hemodialysis) or patients with glomerular filtration rate \<15 ml/min/m2 at inclusion. * history of lobectomy or pneumonectomy lung surgery * severe pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis, etc. * pregnant woman, parturient or nursing mother * adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice) adult person who is unable to give consent * person deprived of liberty by a judicial or administrative decision, * person subject to psychiatric care pursuant to articles l. 3212-1 and l. 3213-1 of the public health code.
covid-19 standard of care in sub-saharan africa

Conditions: Covid19

Summary: this study was conducted in three african countries on four covid-19 care centers (cccs). the cccs were set up in collaboration with a medical ngo with long experience in recording and monitoring data for cohorts and clinical trials in emergency contexts. the data were recorded using the who covid-19 rapid core case report form.


Eligibility criteria:
inclusion criteria: * sars-cov-2 positive at rt-pcr exclusion criteria: * asymptomatic patients