Kornimate/medical-research-clean huggingface dataset:
variability of fluconazole concentration in critically ill patients

Conditions: Invasive Candidiasis

Summary: fluconazole is the first-line agent in the treatment of invasive candidiasis. studies showed inappropriate drug exposure causes high mortality in critically ill patients. under-dosing and ineffective fluconazole trough serum concentrations were found in a recent retrospective study. variability in fluconazole exposure can be easily measured with therapeutic drug monitoring. for patient groups who are at risk for drug underexposure, therapeutic drug monitoring can be valuable regards decreasing mortality.


Eligibility criteria:
inclusion criteria: * patient is 18 years or older. * treatment with fluconazole. * written informed consent obtained from patient. * written informed consent obtained from representative of patient. exclusion criteria: * blood sampling not possible
study of gdx012 in patients with mrd positive aml

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this first-in-human study is to assess the safety, tolerability, antileukemic activity and maximum tolerated dose (mtd) of gdx012 in aml patients who are mrd positive by multiparametric flow cytometry. the study will consist of a dose escalation stage to evaluate various doses of gdx012 after a lymphodepletion regimen comprising fludarabine and cyclophosphamide. following determination of the mtd of gdx012, the study will expand at the mtd. patients will be followed up for 12 months, after receiving gdx012.


Eligibility criteria:
inclusion criteria: * ≥ 18 years old * weight ≥ 40 kg * anticipated life expectancy \> 3 months prior to lymphodepletion * karnofsky performance score ≥ 70% * histologically confirmed diagnosis of aml * in complete response (cr) (including cri/crp); patients in first, second or subsequent cr (including cri/crp) are permitted * mrd detected in bone marrow by mfc * negative pregnancy test (females of childbearing potential only) * agree to use effective birth control * left ventricular ejection fraction (lvef) ≥ 50% * platelet count ≥ 20 x 109/l * prothrombin time or inr ≤ 1.5 x uln (unless receiving therapeutic anticoagulation) * partial thromboplastin time ≤ 1.5 x uln (unless receiving therapeutic anticoagulation) * hemoglobin ≥ 8.0 g/dl * creatinine clearance ≥ 40ml/min * serum total bilirubin ≤ 1.5 x uln (unless documented gilbert's syndrome with direct bilirubin \< 35% of total bilirubin) * alt ≤ 2.5 x uln exclusion criteria: * cytotoxic chemotherapy within 3 weeks * immune therapy within 4 weeks * immunosuppressive therapy within 2 weeks (with exceptions) * investigational treatment or interventional clinical trial within 4 weeks or 5 half-lives (if known), whichever is longer * major surgery within 4 weeks and/or not fully recovered from surgery-related toxicities * known hypersensitivity to chemotherapy, other agents, or excipients used in this study * female patient that is pregnant or lactating/breastfeeding * ongoing toxicity from prior anti-cancer therapy that have not recovered to ≤ grade 1 (with exceptions) * history of chronic or recurrent autoimmune or immune-mediated disease requiring steroids or other immunosuppressive treatments (including anti-tumor necrosis factor agents) * active cns involvement (i.e. leukemic infiltration) * any other malignancy that requires active therapy * uncontrolled intercurrent illness (i.e. acute coronary syndrome in the last 6 months) * active infection with hiv, hepatitis b or hepatitis c note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: aml mrd gamma delta t-cells allogeneic cell therapy
effects of orofacial therapy and therapeutic yoga in children with down syndrome

Conditions: Down Syndrome

Summary: the study aims to compare the effects of orofacial therapy and therapeutic yoga on swallowing, sleep habits, and quality of life in children with down syndrome.

at special education and rehabilitation centers, children diagnosed with down syndrome will undergo initial assessment, and those meeting the inclusion criteria will be included in the study following parental voluntary consent. measurement assessments will be conducted three times: before therapy, after therapy (at week 8), and at a follow-up at week 12. to ensure a fair and unbiased distribution, children participating in the study will be randomly assigned to their respective groups using a sealed envelope method, a widely accepted and transparent randomization technique. 1. grup: routine physiotherapy (pt) group - receiving routine physiotherapy treatment. children who receive routine physiotherapy treatment in special education centers will be evaluated at the end of the 8th session following the treatment. after 12 weeks, the control will be in the form of an evaluation. 2. grup: orofacial therapy + routine pt group - receiving orofacial therapy and routine physiotherapy treatment. for the orofacial therapy, sessions will be held twice a week for eight weeks, with each session lasting 30-45 minutes, totaling 16 sessions. this structured and intensive therapy schedule is designed to provide a comprehensive evaluation of the therapy's effectiveness. secondary evaluations will be conducted following the 8th treatment session, and a follow-up evaluation will be performed after 12 weeks. 3. grup: therapeutic yoga group + routine pt group - receiving therapeutic yoga and routine physiotherapy treatments. the therapeutic yoga group at special education centers will also meet twice weekly for eight weeks, each lasting 30-45 minutes, for 16 sessions. secondary evaluations will be conducted following the 8th treatment session, and a follow-up evaluation will be performed after 12 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of down syndrome * age between 5 and 12 years old * scoring 4 or higher on the peat-10 questionnaire * obtained parental consent form * ability of the child to cooperate exclusion criteria: * conditions that would impede assessment or communication (such as cognitive problems, psychiatric issues, etc.). * children who have undergone any surgery related to orofacial structures and/or received orthodontic treatment. * those with a history of trauma (whiplash injury, condylar trauma, fractures). * children who have received orofacial-related physical therapy treatment within less than 6 months.

Keywords: myofunctional therapy yoga down syndrome quality of life swallowing sleep habits
apixaban discontinuation prior to major surgery

Conditions: Hemorrhage; Thromboembolism

Summary: the adios study is a prospective, observational study will evaluate one hundred and thirty (130) patients with non-valvular atrial fibrillation who are currently receiving treatment with apixaban as indicated to reduce the risk of stroke or systemic embolism, and who require an elective major surgical or invasive procedure will be included in the study. the purpose of the study is to evaluate the efficacy of the recommended pre-procedure washout period of 48 hours.

this study will estimate for what proportion of patients a 48 hour pre-procedure apixaban discontinuation is sufficient to achieve minimal apixaban plasma levels (less than 30 ng/ml) prior to surgery. the investigators hypothesize that this portion will be 80-95%. all patients will have a blood draw at 48 hours prior to procedure and then a second blood draw on the morning of the procedure to test apixaban plasma and anti-xa levels. patients will also receive a follow-up phone call at 30 days to collect information on clinical events.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * on long term anticoagulation with apixaban for treatment of non-valvular atrial fibrillation or venous thromboembolism * undergoing elective major surgery or invasive procedure exclusion criteria: * inability to obtain informed consent for the blood sample draws * any condition precluding collection of follow-up information * participation in another clinical trial * apixaban package insert recommendations and cautions * women of childbearing potential (wocbp) must have a negative serum or urine pregnancy test (minimum sensitivity 25 iu/l or equivalent units of hcg) within 24 hours prior to the start of study drug. * women must not be breastfeeding * wocbp must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug apixaban plus 5 half-lives of study drug apixaban (approximately 3 days) plus 30 days (duration of ovulatory cycle) for a total of 33 days post- treatment completion. * males who are sexually active with wocbp must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug apixaban plus 5 half-lives of the study drug (approximately 3 days) plus 90 days (duration of sperm turnover) for a total of 93 days post-treatment completion. * azoospermic males and wocbp who are continuously not heterosexually active are exempt from contraceptive requirements. however wocbp must still undergo pregnancy testing as described. * the safety and efficacy of apixaban have not been studied in patients with prosthetic heart valves. therefore, use is not recommended in these patients.
isotretinoin, interferon alpha-2b, and paclitaxel in stage iv, recurrent, or persistent cervical cancer

Conditions: Cervical Cancer

Summary: rationale: drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. sometimes when chemotherapy is given, it does not stop the growth of tumor cells. the tumor is said to be resistant to chemotherapy. giving isotretinoin and interferon alpha-2b together with paclitaxel may reduce drug resistance and allow the tumor cells to be killed. purpose: this phase ii trial is studying how well giving isotretinoin and interferon alpha-2b together with paclitaxel works in treating patients with stage iv, recurrent, or persistent cervical cancer.

objectives: * determine the response in patients with stage ivb, recurrent, or persistent cervical cancer treated with isotretinoin, interferon alpha-2b, and paclitaxel. outline: this is a multicenter study. patients receive oral isotretinoin and interferon alpha-2b subcutaneously once daily on days 1-4 and paclitaxel iv over 3 hours on day 4. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 27-66 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically and/or cytologically confirmed cervical cancer, meeting 1 of the following criteria: * stage ivb disease * recurrent disease * persistent disease * patients previously treated with chemoradiotherapy as initial therapy must demonstrate disease progression * measurable disease by physical exam or radiographic studies * not amenable to chemoradiotherapy or surgery patient characteristics: age * over 18 performance status * ecog 0-2 life expectancy * at least 6 months hematopoietic * wbc ≥ 3,500/mm\^3 * platelet count ≥ 100,000/mm\^3 hepatic * sgot and sgpt ≤ 2 times upper limit of normal * bilirubin ≤ 1.5 mg/dl renal * creatinine ≤ 1.5 mg/dl or * creatinine clearance ≥ 50 ml/min other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no known hiv positivity * no active infection * no medical condition that would preclude study compliance prior concurrent therapy: biologic therapy * no prior interferon * no other concurrent immunotherapy chemotherapy * see disease characteristics * at least 3 months since prior chemoradiotherapy (6 weeks for patients experiencing disease progression after completion of initial chemoradiotherapy) * no other prior chemotherapy endocrine therapy * no concurrent hormonal therapy for cancer radiotherapy * see disease characteristics * see chemotherapy * recovered from prior radiotherapy * no concurrent radiotherapy surgery * recovered from prior surgery * no concurrent surgery for cancer other * no prior retinoids * no other concurrent anticancer therapy * no other concurrent experimental agents

Keywords: recurrent cervical cancer stage ivb cervical cancer
a multiple ascending dose study with azd9164 given for 13 days in healthy male and female subjects and in patients with chronic obstructive pulmonary disease

Conditions: Healthy; COPD

Summary: the purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled azd9164 following administration of multiple ascending doses in healthy male and female subjects and copd patients.


Eligibility criteria:
inclusion criteria: * healthy male and female, age 18-45, copd patients \> 40 years * healthy subjects and copd patients; provision of signed and dated, written informed consent prior to any study specific procedures * healthy subjects; females must have a negative pregnancy test, must not be lactating and must be of non-child-bearing potential, by the following criteria: - irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy * copd patients; females must have a negative pregnancy test, must not be lactating and must be of non-child-bearing potential, by the following criteria: post menopausal. woman below 50 years old will be considered post menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments, and with lh and fsh levels in the post menopausal range. women over 50 years of age will be considered post menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment. - irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy * healthy subjects; have a body mass index (bmi) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg * copd patients; have a body mass index (bmi) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg exclusion criteria: * healthy subjects; any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the subject's ability to participate in the study * copd patients; any clinically significant disease or disorder (other than copd) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the subject's ability to participate in the study * healthy subject and copd patients; any clinically significant abnormalities in clinical chemistry, haematology, urinalysis or physical examination results as judged by the investigator * healthy subject and copd patients; any clinically important abnormalities in rhythm, conduction or morphology of resting ecg that may interfere with the interpretation of qtc interval changes

Keywords: phase i safety study azd9164
effectiveness of botox, dry needling, pharmacological treatment, and manual therapy for bruxism-induced myalgia

Conditions: Myalgia; Bruxism; Quality of Life

Summary: eighty individuals (44 female, 36 male), which were randomly divided into 4 groups of 20 patients each, due to the treatment type: botulinum toxin (btx); dry needling (dn); pharmacological therapy (pt) and manual therapy (mt). all treatments were carried out by the same maxillofacial surgeon. an informed consent form was obtained from all participants.

the study aimed to assess and compare the effectiveness of 4 different methods in the management bruxism: botulinum toxin (btx-a), dry needling (dn), pharmacological therapy (pt), and manual therapy (mt). 80 bruxist patients (44 female, 36 male) were randomly divided into 4 groups of 20 patients each. botulinum toxin, dry needling, pharmacological therapy and manual therapy were carried out by the same maxillofacial surgeon in all patients. the following measurements were recorded by another investigator in each group, at baseline (before treatment) and at post-treatment intervals of 2nd, 4th, and 12th weeks; visual analogue scale (vas) for pain, maximum painless mouth opening (mm), oral health impact profile14 (ohip-14).

Eligibility criteria:
inclusion criteria: * adult patients aged 18 to 65 years with complete dentition, * patients classified as american society of anesthesiologists (asa) physical status asa i or asa ii * patients experiencing moderate to severe pain in the masticatory muscles related to bruxism, * patients who had not previously been treated for bruxism * patients who were diagnosed with bruxism were excluded from the study. exclusion criteria: * presence of temporomandibular joint disorder * known allergy to botulinum toxin * pregnancy * presence of neuromuscular disease * chronic use of muscle relaxant medication within the last 3 months.

Keywords: myalgia botulinum toxin bruxism dry needling manual therapy
atomoxetine's effects on nicotine response and stress response in smokers

Conditions: Nicotine Dependence

Summary: the purpose of this study is to evaluate atomoxetine's effects on the rewarding and reinforcing effects of nicotine in a controlled human laboratory study with 24 otherwise healthy nicotine dependent subjects. it is hypothesized that atomoxetine will attenuate the negative effects of nicotine.


Eligibility criteria:
inclusion criteria: * female and male smokers, not treatment seeking, aged 18 to 55 years; * history of smoking daily for the past 12 months, at least 5 cigarettes daily; * co level \> 10ppm; * for women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods. exclusion criteria: * history of major medical illnesses including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment, coronary artery disease, cardiac rhythm disturbances or other medical conditions that the study physician deems contraindicated for the subject to be in the study; * regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) * recent psychiatric diagnosis and treatment for axis i disorders including major depression, bipolar affective disorder, schizophrenia and panic disorder within the past year. we will make an exception for the following axis i diagnoses: nicotine dependence and alcohol or other drug dependence (i.e., cocaine, opioid) as long as they are not meeting abuse or dependence criteria within the past 3 months for alcohol or drug use; * use of drugs that slow heart rate (eg, beta-blockers), which may increase the risk of bradycardia and av block, or nsaids, which may increase potential for developing ulcers/active or occult gastrointestinal bleeding; * known allergy to atomoxetine

Keywords: nicotine smoking atomoxetine stress
suggamadex and fast-track cardiac anesthesia in a developing country

Conditions: Suggamadex; Surgery for Congenital Heart Disease

Summary: the purpose of this study is to retrospectively review our preliminary experience during a surgical trip to tuxtla, mexico, using suggamadex to reverse neuromuscular blockade following cpb and cardiac surgery for repair of chd in infants and children.


Eligibility criteria:
inclusion criteria: * patients who underwent cardiac surgery and cardiopulmonary bypass in tuxtla, mexico in september 2015. exclusion criteria: * none
a randomised, db, placebo-controlled study of bi 1356 for 18 weeks followed by a 34 week double-blind extension period (placebo patients switched to glimepiride) in type 2 diabetic patients for whom treatment with metformin is inappropriate

Conditions: Diabetes Mellitus, Type 2

Summary: efficacy of bi 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). the second part of the study looks at the safety of bi 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride)


Eligibility criteria:
inclusion criteria patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control (hba1c 7% to 10%) for whom metformin therapy is inappropriate (intolerability or contraindication) exclusion criteria myocardial infarction, stroke or transient ischaemic attack in last 6 months treatment with rosiglitazone or pioglitazone, glp-1 analogues, insulin or anti-obesity drugs in past 3 months impaired hepatic function severe renal impairment current treatment with systemic steroids change in dosage of thyroid hormones hereditary galactose intolerance
sugammadex and heart failure

Conditions: Postoperative Neuromuscular Block

Summary: although anticholinesterase reversal agents have been used in combination with anticholinergic drugs for over half a century, it has been suggested that they should be used with caution in patients with underlying cardiovascular disease. as sugammadex has no endogenous targets, it is unlikely to cause any adverse cardiovascular effects. this selective relaxant binding agent is specifically designed to encapsulate rocuronium, which can, therefore, promptly restore neuromuscular function regardless of any levels of nmb as the dose is increased. some reports, however, suggest that sugammadex may have increased time to effect in some patient populations like the elderly, patients in intensive care and renal failure patients. a less dynamic circulation and increased transfer time to the effector site in these subjects are likely explanations for this effect. the present trial was designed to assess the safety and efficacy of sugammadex 2.0 mg kg-1 for the reversal of rocuronium-induced nmb in patients with heart failure.


Eligibility criteria:
inclusion criteria: * aged 18 yr or older * categorized as american society of anesthesiologists class 3-4 and new york heart association class 2-4 * with an ejection fraction \<25% * scheduled to undergo elective surgery for cardiac resynchronization therapy, an automated implantable cardioverter-defibrillator (icd), or battery replacement of an icd or biventricular pacemaker, during general anaesthesia. exclusion criteria: * expected to have a difficult intubation for anatomic reasons * they had a neuromuscular disorder * a personal or family history of malignant hyperthermia * or known allergy to medication used during general anaesthesia * not able or willing to give written informed consent.

Keywords: antagonists neuromuscular block neuromuscular block, monitoring neuromuscular function