Kornimate/medical-research-clean huggingface dataset:
dose-reduced versus standard conditioning in mds/saml

Conditions: Myelodysplastic Syndromes; Secondary Acute Myeloid Leukemia

Summary: in this trial dose reduced conditioning is compared to standard conditioning followed by allogeneic stem cell transplantation from related or unrelated donors in patients with mds or secondary aml. conditioning is the very high dose chemotherapy treatment that is given in the days before the stem cell transplant. the hypothesis is that a dose reduced conditioning will reduce the non-relapse mortality from 40% to 20% at one year after allogeneic stem cell transplantation.


Eligibility criteria:
inclusion criteria: * disease: cytologically proven primary or therapy-related myelodysplastic syndrome (mds), either as * refractory anaemia (ra) according fab or ra with or without dysplasia according who, * refractory anaemia with ringsideroblasts (rars) according fab or rars with or without dysplasia according who, * refractory anaemia with excess of blasts (raeb) according fab or raeb i or raeb ii according who, * refractory anaemia with excess of blast in transformation (raeb t) according fab, * cmml (dysplastic type) according who, * or secondary acute myeloid leukaemia (saml). * blast count \< 20 percent in bone marrow with or without chemotherapy at time of transplantation. * patient eligible for standard and dose-reduced conditioning as per local guideline. * patient age 18 - 60 years if donor is a hla-matched unrelated donor (hla-a, hla-b, hla-drb1 and hla-dqb1) (one mismatch allowed): * patient age 18 - 65 years if donor is a hla-matched related donor ((hla-a, hla-b, hla-drb1 and hla-dqb1) (one anti¬gen-mismatch allowed): * no major organ dysfunction. * written informed consent of the patient. exclusion criteria: * blasts \> 20 % in bone marrow at time of transplantation * no written informed consent. * central nervous involvement. * severe irreversible renal, hepatic, pulmonary or cardiac disease, such as * total bilirubin, sgpt or sgot \> 2 times upper the normal level. * left ventricular ejection fraction \< 30 %. * creatinine clearance \< 30 ml/min. * dlco \< 35 % and/or receiving supplementary continuous oxygen. * positive serology for hiv. * pregnant or lactating women. * patients with a life-expectancy of less than six months because of another debilitating disease. * serious psychiatric or psychological disorders. * invasive fungal infection at time of registration.

Keywords: reduced intensity conditioning myeloablative conditionig allogeneic stem cell transplantation mud
comparison of two insulin degludec formulations in subjects with type 2 diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in the united states of america (usa). the aim of this trial is to compare the efficacy and safety of two different formulations of insulin degludec (ideg) in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes (diagnosed clinically) for minimum 24 weeks prior to randomisation (visit 2) * current treatment with basal-only insulin (no prandial insulin) consisting of either insulin detemir once daily (od), insulin glargine od or neutral protamine hagedorn (nph) insulin od/twice daily (bid) for at least 12 weeks prior to randomisation (visit 2), in combination with stable doses of oad(s) (metformin, insulin secretagogue (sulfonylurea or glinide), alpha-glucosidase inhibitor, pioglitazone or dipeptidyl peptidase iv (dpp-iv) inhibitor in any approved (according to label) dose or combination. stable oad doses are defined as unchanged doses for at least 12 weeks prior to randomisation (visit 2) * hba1c (glycosylated haemoglobin) between 7.0-10.0% (both inclusive) by central laboratory analysis * body mass index (bmi) below or equal to 45 kg/m\^2 * ability and willingness to adhere to the protocol including self-measured plasma glucose (smpg) according to the protocol exclusion criteria: * treatment with rosiglitazone within the last 12 weeks prior to randomisation (visit 2) * treatment with glucagon like peptide-1 (glp-1) receptor agonists within the last 12 weeks prior to randomisation (visit 2) * recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator (trial physician) * previous participation in this trial. participation is defined as randomised. re-screening is allowed once during the recruitment period * known or suspected hypersensitivity to trial products or related products * the receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)
add-on low dose dextromethorphan and memantine in patients with amphetamine-type stimulants use disorder

Conditions: Stimulants Use Disorder

Summary: the current study will investigate whether add-on dextromethorphan (dm) and memantine (mm) is able to improve the treatment outcomes for atsud, and be associated with improvement in inflammatory markers, neurotrophic factors and neuropsychological tests.

in current study, we will conduct a randomized double-blind placebo-controlled study. we will recruit 100-120 patients with atsud in three years and allocate them to add-on low dose dextromethorphan and memantine (dm 30mg/day+mm 5mg/day) or placebo group in a 1: 1 ratio (patients will also undergo usual psychosocial interventions). we will follow up the participants for 12 weeks and measure the treatment responses, urine drug tests, craving scales and side effects to evaluate the therapeutic effects of add-on dm+mm. neuropsychological assessments and tests for inflammatory parameters and neurotrophic factors will also be measured during 12-weeks follow up. the study results will show that whether add-on dm+mm is able to improve the treatment outcomes for atsud, and be associated with improvement in inflammatory markers, neurotrophic factors and neuropsychological tests.

Eligibility criteria:
inclusion criteria: patients must meet all of these inclusion criteria to be eligible for enrollment into the study: 1. signed informed consent by patient or legal representative. 2. male or female patient aged ≧20 and ≦65 years. 3. a diagnosis of atsud according to dsm criteria made by a specialist in psychiatry. 4. patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study. exclusion criteria: the presence of any of the following will exclude a patient from study enrollment: 1. women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study. 2. females who are pregnant or lactation. 3. other major axis-i dsm-iv diagnosis other than atsud, except for tobacco use disorder, ats induced mood or psychotic disorders. 4. current evidence of an uncontrolled and/or clinically significant medical condition, e.g., cardiac, hepatic and renal failure that would compromise patient safety or preclude study participation. 5. history of allergy or intolerable side effects of dm or mm. 6. suicidal attempts or risks during screen or study period. 7. presence of active infectious or autoimmune disease.

Keywords: amphetamine-type stimulants use disorder dextromethorphan memantine inflammation neurodegeneration
evaluation of systemic microvascular endothelial function in metabolically healthy obesity

Conditions: Obesity; Dyslipidemias

Summary: obesity is known to be a risk factor for cardiovascular disease (cvd), type 2 diabetes mellitus, gastrointestinal tract disease, respiratory problems (such as obstructive sleep apnea), joint and muscle problems, reproductive disorders, depression and cancer. however, recently a new classification has emerged about obesity, the metabolically healthy obesity (mho). according to the definition of the term, mho represents obesity that occurs segregated from the metabolic syndrome criteria defined by the international diabetes federation (idf). however, as there is still disagreement about the definition of mho, the cardiovascular risk of these individuals is also uncertain. this phenotype may present as an intermediate risk between metabolically healthy normal-weight individuals and metabolically unhealthy obese individuals (muo) or as a transition stage of the disease; when evolving to muo, represents a higher risk of developing cvds. the hypothesis of the present study is that obese individuals classified as metabolically healthy have worse vascular endothelial function when compared to non-obese individuals, demonstrating increased cardiovascular risk even in this subgroup considered "low risk". the detection of endothelial dysfunction in metabolically healthy obese may help in the prevention, treatment and follow-up of these individuals, aiming to reduce the development and morbidity and mortality of cvd. in the present study, the investigators will use a laser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function.


Eligibility criteria:
inclusion criteria: • obese individuals (bmi ≥ 30.0 kg / m2) meeting the criteria for metabolically healthy obesity exclusion criteria: * pregnancy or lactation. * endocrine disorders except diabetes, cardiovascular disease except systemic arterial hypertension, autoimmune diseases, malignant neoplasms.

Keywords: laser speckle contrast imaging
special drug use investigation for paxil tablet (pediatric panic disorder)

Conditions: Panic Disorder

Summary: the objectives of this survey was to retrospectively collect and evaluate the information on the efficacy and safety of paxil tablets ("paxil", hereinafter) in pediatric subjects (aged under 18) with panic disorder under conditions of actual use.


Eligibility criteria:
inclusion criteria: * aged under 18 at the time of the panic disorder diagnosis * aged under 18 on the starting day of paxil treatment * having been making periodic visits to the hospital to receive treatment for panic disorder exclusion criteria: * subjects who have been treated with paroxetine prior to this investigation * subjects with hypersensitivity to paroxetine * subjects taking monoamine oxidase inhibitors (maois) or within 2 weeks of stopping treatment with maois * concomitant use in patients taking pimozide
up-down determination of the ed90 of phenylephrine for hypotension prophylaxis in cesarean delivery

Conditions: Spinal Induced Hypotension in Cesarean Delivery

Summary: this study is designed to determine the ed90 for an infusion of phenylephrine to prevent spinal induced low blood pressure in parturients presenting for an elective cesarean delivery. the up-down methodology (udm) is commonly used study method to determine the dose of a drug that causes the desired effect in over 90% of the subjects to whom it given. for example: the investigators want to know what is the best dose of phenylephrine (from a range of commonly used doses) to prevent a drop in blood pressure during cesarean delivery ninety times out of one hundred when it is given at that dose. the ed90 is the effective dose at which 90% of subjects will have a "positive" response to a phenylephrine infusion, i.e. no drop in blood pressure. the investigators hypothesize that the ed90 will be between 40 - 60 mcg/min. the primary outcome measure is the ed90 for phenylephrine infusions that prevents a drop in blood pressure in women undergoing cesarean delivery.


Eligibility criteria:
inclusion criteria: 1. non-emergent cesarean delivery with planned spinal anesthesia (i.e. elective planned cesarean delivery for malposition, patient choice, cervical pelvic disproportion, previous cesarean delivery and other diagnosis that require a predetermined cesarean delivery) 2. american society of anesthesia physical status class i \& ii (asa i - healthy, asa ii - mild and controlled systemic disease, eg. controlled essential hypertension) 3. age ≥ 18 years (standard within the obstetrical literature) 4. term gestational age 5. english-speaking exclusion criteria: 1. morbid obesity (body mass index ≥ 45 kg/m2) (morbidly obese parturients require a dose of local anesthetic less than the standardized dose in this study, typically have an exaggerated response to vasopressors, and the blood pressure cuff occasionally needs to be replaced by an intra-arterial catheter due to limitations in size) 2. height \< 5'0" (women \< 5'0" are likely to require a dose of local anesthetic less than the standardized dose in this study) 3. laboring women 4. urgent or emergency cesarean delivery 5. hypertensive disease of pregnancy 6. severe maternal cardiac disease 7. subjects on monoamine oxidase inhibitors (maoi's) or tricyclic antidepressants 8. fetal anomalies or intrauterine fetal death 9. failed spinal anesthesia 10. subject enrollment in another study involving a study medication within 30 days of cd 11. any other physical or psychiatric condition which may impair their ability to cooperate with study data collection
periarticular multimodal drug injections in total knee arthroplasty

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to determine whether periarticular multimodal drug injection (pmdi) would provide additional benefits in patients after total knee arthroplasty (tka) for whom contemporary pain control protocols using the continuous femoral nerve block, intra-venous patient controlled analgesia (iv-pca)and preemptive oral medications. we hypothesized that pmdi would reduce pain level and consumption of pca and acute pain rescuer and would provide better functional recovery and patient satisfaction. we also hypothesized that the incidence of side effects and complications of the pmdi would be similar to the no-pmdi.

the preemptive multimodal approaches are regarded as a current standard pain management protocol. recently, periarticular multimodal drug injection (pmdi) has been considered to be one of the most effective and important component in multimodal approaches. because the contemporary pain management protocol using the regional anesthesia, continuous femoral nerve block (fnb) and intravenous patient-controlled analgesia (pca) has been proved significantly improved analgesic effects itself, little information whether the pmdi would provide additional pain relief under this pain management protocol is available. also, because the safety of the high dose local anesthetics and narcotics has not been clarified, a selective application should be considered to patients who were expected to show better analgesia if there were certain patient related factors to predict the additional pain relief effect of the pmdi. thus, this prospective double-blind randomized study was conducted to determine whether pmdi would provide additional benefits in patients after total knee arthroplasty (tka) for whom contemporary pain control protocols using the continuous femoral nerve block, iv-pca and preemptive oral medications in terms of pain relief, consumption of pca and acute pain rescuer, patients satisfaction, functional recovery, side effects and complications.

Eligibility criteria:
inclusion criteria: * diagnosis of primary osteoarthritis * scheduled for elective total knee arthroplasty * signed written informed consent * spinal anesthesia exclusion criteria: * patients refusing consents * inability to use the outcome assessment tools * contraindications to regional anesthesia * severe cardiovascular disease * allergy or contraindication to drugs used in this study * pre-existing neurologic disease including psychiatric disorder * drug abuser

Keywords: periarticular multimodal drug injection
a study to evaluate whether food has an effect on the uptake of solifenacin and tamsulosin when administered in a combination tablet

Conditions: EC905; Pharmacokinetics; Healthy Subjects

Summary: to evaluate the effect of food (low and high fat breakfast vs. fasting) on the pharmacokinetics (what the body does to the drug) of a single dose of solifenacin and tamsulosin administered as combination tablet ec905. also to evaluate the safety and tolerability of single doses of ec905 in young, healthy male subjects, when administered under fed (low and high fat) or fasting conditions.

subjects are admitted to the clinic on day -1 and receive a single dose of the combination tablet ec905 on the first day of 3 periods, under three conditions (high fat breakfast, low fat breakfast, and fasting) in order to evaluate the effect of food. blood sampling for pharmacokinetic (pk) assessment is performed on the dosing day and for 11 days after dosing in each period. this 11-day on-site period is repeated three times so that all subjects are dosed under all conditions. each period is separated by 7 days off site. subjects return for an end of study visit (esv) at least 7 days after the last 11 day on-site period, or after withdrawal. on day 1 of each of 3 periods, subjects are given a single dose of ec905 under three conditions (high fat breakfast, low fat breakfast and fasting) in order to evaluate the effect of food on the pk of solifenacin and tamsulosin hcl. the aim is to show the absence of a food effect after a low fat breakfast vs. fasting conditions, and to evaluate the food effect after a high fat breakfast vs. fasting conditions. subjects are randomized to one of 6 possible sequences of fasted or fed conditions. screening takes place from day -21 to day -1. they are admitted to the clinic on day -1. blood sampling for pk assessment is performed from day 1 to day 11 of each period. this 11 day on-site period is repeated three times in order to allow all subjects to be dosed under fed (low and high fat) and fasting conditions. the 11 day on-site periods are separated by 7-day off site periods; subjects are checked for eligibility again one day prior to the start of a new dosing day. safety assessments are performed throughout the investigational period. subjects return for an esv at least 7 days after the last 11 day on-site period, or after withdrawal.

Eligibility criteria:
inclusion criteria: * bmi between 18.5 and 30.0 kg/m2, inclusive. exclusion criteria: * known or suspected hypersensitivity to solifenacin, tamsulosin or any of the other recipients of ec905. * any of the contraindications or precautions for use as mentioned in the applicable sections of the summary of product characteristics (spc) of tamsulosin or solifenacin * use of grapefruit (more than 3 x 200 ml) or marmalade (more than three times) in the week prior to admission to the clinical unit, as reported by the subject.

Keywords: phase i combination tablet ec905 omnic ocas® vesicare® food effect vesomni vesiflow urizia
18f-fluorthanatrace (pet/ct) in glioblastoma

Conditions: Glioblastoma

Summary: the subject will be a candidate for this imaging study because they have agreed to participate in a treatment study involving ttfields (optune device), a device that uses low intensity, wave like electrical fields, and a parp inhibitor drug (niraparib). the research study is being conducted to test how a new radioactive imaging drug called 18f-fluorthanatrace (18f-ftt) can be used to image sites of recurrent brain cancer before or after new treatment or surgery. 18f-ftt is a drug used with an imaging test called positron emission tomography/computed tomography (pet/ct).

participants will undergo up to three \[18f\]ftt pet/ct scans at the following time points: * baseline: subjects from either cohort may agree to undergo a baseline \[18f\]ftt pet/ct prior to the start of ttfields therapy to measure baseline ftt uptake. this scan is not required and may be omitted at the discretion of the investigator or based on subject availability. * post-ttfields: subjects from both cohorts will undergo an \[18f\]ftt pet/ct scan 3-7 days after initiation of ttfields therapy and before surgical resection or initiation of niraparib. this scan will measure the ftt uptake after ttfields therapy is initiated. this scan is required. * post-parpi: subjects from cohort a may agree to undergo an post-therapy \[18f\]ftt pet/ct scan 1- 21 days after the initiation of niraparib to collect pilot data on the changes in ftt uptake after ttfields and niraparib combination therapy. this scan is not required and may be omitted at the discretion of the investigator or based on subject availability. for each \[18f\]ftt pet/ct imaging session, participants will undergo approximately 60 minutes of dynamic brain scanning starting nearly simultaneously with the injection of \[18f\]ftt. a second optional brain scan will be done at approximately 90 minutes post-injection. each imaging session will include an injection of up to 12 mci (approximate range for most studies is anticipated to be 8-12 mci) of \[18f\]ftt.

Eligibility criteria:
inclusion criteria: 1. participants will be ≥ 22 years of age 2. participants will have a diagnosis of glioblastoma and be enrolled in the companion treatment trial, irb 832694. 3. participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures. exclusion criteria: 1. females who are pregnant or breast-feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of childbearing potential at screening. 2. inability to tolerate imaging procedures in the opinion of an investigator or treating physician. any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
effect of gait training with auditory stimuli on balance, gait & funtional independence in stroke

Conditions: Stroke

Summary: to determine the effect of gait training with auditory stimuli on dynamic balance, gait and functional independence on chronic stroke.

the purpose of this study is to find the effect of gait training with auditory stimuli using a smart phone metronome application on dynamic balance, gait and functional abilities of chronic stroke patients.

Eligibility criteria:
inclusion criteria: * both gender * age between 30-70 * more than 6 months after the stroke * able to walk more than 10 meters independently * mmse score of 24 exclusion criteria: * dependent gait * aphasia * any hearing or visual defects * moderate to severe cognitive disorder * people not willing to participtae