Kornimate/medical-research-clean huggingface dataset:
a study of ly2181308 sodium in patients with relapsed or refractory acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this study is to understand the safety profile of ly2181308 sodium administered in combination with idarubicin and cytarabine to patients with relapsed or refractory acute myeloid leukemia (aml).


Eligibility criteria:
inclusion criteria: * patients who have a diagnosis of acute myeloid leukemia that is relapsed or refractory to at least 1 prior treatment for leukemia, or patients with chronic myeloid leukemia (cml) who are in myeloid blast crisis which have failed at least 1 previous tyrosine kinase inhibitor (tk1). a baseline bone marrow assessment is required less than or equal to 96 hours prior to the first dose of study drug. * must have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, cancer related hormone therapy, or other investigational therapy for at least 21 days for myelosuppressive agents (such as cytarabine, daunorubicin, and gemtuzumab ozogamicin) or 14 days for non-myelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (such as neurotoxicity, diarrhea, and mucositis) except for residual myelosuppression and alopecia. hydroxyurea is permitted to control the peripheral blast cell count, but must be stopped at least 24 hours before study drug administration. * must have adequate organ function. * females must have a negative pregnancy test. male and female patients must agree to use a reliable method of birth control during and for 6 months following the last dose of study drug. * patients must be at least 18 years old. exclusion criteria: * have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a non-myelosuppressive or myelosuppressive agent, respectively. * patients with acute promyelocytic leukemia (apml). * major surgery within 4 weeks of study enrollment. * patients with serious pre-existing medical conditions (at the discretion of the investigator). because of the known cardiac toxicity of anthracyclines, patients with pre-existing ejection fraction (ef) less than or equal to 45% should not participate in this study. no patient should exceed the maximum exposure of anthracycline doses (for example, idarubicin greater than 120 mg/m²). * patients with a second malignancy that could affect the interpretation of the results. * patients with leukemic involvement of the central nervous system (cns) by spinal fluid cytology or imaging. * patients with known coagulopathy or bleeding disorder, other than leukemia related thrombocytopenia. patients with severe of life threatening bleeding refractory to platelet transfusions are also excluded. * concomitant anticoagulant therapy (with the exception of heparinized saline to maintain the patency of central venous catheters). * women who are pregnant or breast feeding. * patients with a known hypersensitivity to oligonucleotides, idarubicin, and/or cytarabine.
thalidomide in treating patients with myelofibrosis

Conditions: Primary Myelofibrosis

Summary: phase ii trial to study the effectiveness of thalidomide in treating patients who have myelofibrosis. thalidomide may stop the growth of myelofibrosis by stopping blood flow to the cancer cells.

primary objectives: i. to investigate whether thalidomide, a potent inhibitor of angiogenic and fibrogenic growth factors, is an effective therapeutic agent in patients with mmm. specifically, to assess whether thalidomide improves anemia and/or organomegaly in patients with mmm. ii. to assess the effects of thalidomide on the myelofibrotic stroma with respect to microvascular architecture and angiogenesis, collagen and reticulin deposition, and the expression of the mediating growth factors bfgf, tgf-b, and pdgf, and their respective receptors. outline: this is a multicenter study. patients receive oral thalidomide once daily for 1 year in the absence of disease progression or unacceptable toxicity. patients with stable or responding disease may receive 1 additional year of therapy. patients are followed every 6 months until 5 years from study entry.

Eligibility criteria:
inclusion criteria: * histologically confirmed myelofibrosis with myeloid metaplasia * agnogenic myeloid metaplasia * post-polycythemic myeloid metaplasia * post-thrombocythemic myeloid metaplasia * no metastatic carcinoma, lymphoma, myelodysplasia, hairy cell leukemia, mast cell disease, acute leukemia (including m7), or acute myelofibrosis * no chromosomal translocation t(9;22) or bcr/abl gene rearrangement * presence of reticulin fibrosis in bone marrow and leukoerythroblastosis and dacrocytosis in peripheral blood * presence of anemia (hemoglobin less than 10 g/dl), palpable splenomegaly, or hepatomegaly * performance status - ecog 0-2 * absolute neutrophil count greater than 750/mm\^3 * platelet count less than 400,000/mm\^3 * wbc less than 50,000/mm\^3 * bilirubin no greater than 2 mg/dl (if total bilirubin elevated, direct bilirubin must be normal) * ast no greater than 3 times upper limit of normal (uln) * alkaline phosphatase no greater than 3 times uln * creatinine no greater than 1.5 mg/dl * creatinine clearance at least 60 ml/min * not pregnant or nursing * negative pregnancy test * fertile women must use at least 1 highly active method and 1 additional effective method of contraception for at least 4 weeks before study, during study, and for at least 4 weeks after study * fertile men must use effective contraception during study and for at least 4 weeks after study * no uncontrolled infection * no concurrent condition that would preclude study * no peripheral neuropathy * at least 1 month since prior interferon, pirfenidone, anagrelide, or epoetin alfa * at least 1 month since prior hydroxyurea or other chemotherapy * at least 1 month since prior corticosteroids or androgen derivatives
a single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fed conditions

Conditions: Healthy

Summary: single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fed conditions

a single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fed conditions: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study

Eligibility criteria:
inclusion criteria: * healthy, non-smoking, male and female subjects, 18 years of age or older * bmi ≥ 19.0 and ≤ 30.0 kg/m2. * females who participate in this study will be of chilbearing or nonchildbearing potential exclusion criteria: • known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results
assessment of the prognostic value of the thickness of the quadriceps and abdominal muscles measured by ultrasound for 28-day mortality in postoperative icu patients

Conditions: Sarcopenia ICU Ultrasound

Summary: ultrasound measurement of muscle thickness, particularly of the quadriceps, can be used to highlight a reduction in lean mass. sarcopenia is annvoluntary loss of lean mass, and it is a frequent and major problem in the intensive care unit (icu). sarcopenia is associated with significant morbidity and mortality, as previously demonstrated by ct scan measurements. nevertheless, due to its nature and cost, it does not appears reasonable to perform ct sarcopenia evaluation in all icu patients. described in the literature as evolving rapidly upon admission to icu, accurate assessment of this loss of muscle mass would allow early detection of sarcopenia and adaptation of therapeutic management, particularly nutritional and rehabilitative. there are many advantages to evaluating sarcopenia by ultrasound measurement: simple, rapid, achievable at the patient's bedside, no exposure to radiation, non-invasive, and low cost. the abdominal muscles (external oblique, internal oblique, transverse) constitute the accessory respiratory muscles. easily accessible by ultrasound, they are a potential target for the evaluation of sarcopenia, which could be responsible for ventilatory withdrawal failures, prolonged stays in intensive care and associated complications. the combined ultrasound measurement of the quadriceps and accessory respiratory muscles in icu patients therefore appears to be an innovative approach. considering the ease of implementation, the validity of ultrasound (confirmed in the literature), and the safety of the technique, we wish to evaluate the link between the muscle mass at arrival in the postoperative intensive care unit of the dijon university hospital by ultrasound measurement of the quadriceps and accessory respiratory muscles, and: mortality, duration of mechanical ventilation, length of stay and occurrence of intercurrent events.


Eligibility criteria:
inclusion criteria: * person who has not opposed (or non-opposition of health care proxy for patients who are comatose or under the influence of sedative drugs) after receiving information about the study * all adult patients admitted to the postoperative intensive care unit. exclusion criteria: * protected adult or minor * pregnant or breastfeeding woman * lower limb amputation * refusal to participate of the patient or health care proxy * patient with pre-existing neuromuscular condition, tetra or paraplegia * morbid obesity as defined by bmi ≥ 40 * bpco stage ≥ 3; heart failure with lvef \< 50%; patients with symptomatic valvulopathy
sustaining and improving clinicians' use of evidence-based psychotherapy (ebp) for ptsd

Conditions: Post Traumatic Stress Disorder

Summary: the purpose of the study is to compare the impact of two strategies to sustain and improve the delivery of an evidence-based psychotherapy for ptsd, cognitive processing therapy (cpt) in three different mental health systems. these approaches are based on two different theories of what is necessary to promote successful implementation. we will examine whether these strategies lead to improved patient outcomes, clinician skill, proportion of clients who receive cpt, and other outcomes that are relevant to the implementation of evidence-based psychosocial treatments. by examining these questions in 3 different mental health systems, we will also examine whether the implementation strategies yield different results in different systems.

this project will compare two different methods of post-training support to promote sustained and improved cpt delivery: fidelity-oriented learning community (fid-lc) and continuous quality improvement learning community (cqi-lc). clinics in which clinicians have previously received cpt training will be randomly assigned to one of these conditions. outcomes will be observed changes in patient symptoms during and following treatment, independent expert assessment of clinician fidelity and adaptations in delivering the psychotherapy (via audio-recordings), proportion of eligible caseloads that receive cpt, and capacity to deliver cpt. data will also be collected to assess clinician and setting characteristics that may contribute to the success of each strategy. the study results will help inform how best to support the ongoing implementation and benefits of evidence-based psychotherapy (e.g., cpt) in routine clinical settings. this is a knowledge translation project in partnership with 3 systems; va canada, u.s. veterans health care system and the national centre for ptsd.

Eligibility criteria:
inclusion criteria: * all clinicians that provide psychotherapy to patients with ptsd * agree to provide cpt to 6 patients over 2 years * consent to be randomized to one of two study conditions * are willing to record therapy sessions * continue to have computer/internet access. * patients will be clients of clinician participants that 1. are 18 years or older 2. have a diagnosis of ptsd 3. are willing to have their sessions audiorecorded exclusion criteria: * ineligible patient participants are those having 1. current uncontrolled psychotic or bipolar disorder 2. unremitted substance dependence 3. current imminent suicidality or homicidality that requires imminent attention 4. significant cognitive impairment

Keywords: trauma
study of propranolol as anti-adhesive therapy in sickle cell disease (scd)

Conditions: Sickle Cell Disease

Summary: an open label, prospective, randomized cross-over phase ii study in up to 60 sickle cell patients who are either homozygous for hb s or have hbsb0 thalassemia. initially, each patient will be treated for 6 weeks with placebo or a standard dose of propranolol (40 mg) every 12 hrs. this will be followed by a 2-week washout period after which, patients will receive the other treatment modality (placebo or propranolol). we hypothesize that propranolol administered in vivo on a daily basis for 6 weeks (1) will decrease baseline adhesion to endothelial cells and will substantially abrogate epinephrine-stimulated adhesion to endothelial cells, as measured in vitro; (2) will improve biomarkers of endothelial activation and dysfunction; and (3) can be safely used in patients with scd. thus, the use of propranolol in scd may represent a safe and effective means of anti-adhesive therapy in scd. study objectives: primary objective: • to establish the safety and efficacy of long-term therapy with propranolol as an anti-adhesive therapy for scd. secondary objective: • to evaluate changes in soluble markers of endothelial activation and dysfunction. correlative science objective: • to determine whether response to propranolol therapy is associated with polymorphisms in genes encoding the proteins involved in the upregulation of sickle red blood cell (ss rbc) adhesion by epinephrine.


Eligibility criteria:
inclusion criteria: * diagnosis by electrophoresis (hep) of hemoglobin (hgb) ss or hgb sβ0 thalassemia (all patients followed at our clinic have hep-confirmed diagnosis on file) * age ≥ 18 years * blood pressure (bp) systolic ≥ 95mm hg and diastolic ≥ 50mm hg * heart rate (hr) ≥ 70 and ≤ 110 bpm * oxygen saturation by pulse oximeter and at room air ≥ 92% * hematocrit (hct) ≥ 20% and hb \> 6.0 g/dl * euthyroid status as indicated by normal thyroid stimulating hormone (tsh) * ss rbcs obtained during screening period demonstrating an adhesion response to epinephrine of 40% over non-stimulated baseline adhesion to endothelial cells * capacity to understand and sign informed consent exclusion criteria: * history of vaso-occlusive episode during the 6 wks prior to screening * rbc transfusion during the 3 months prior to study entry * ongoing pregnancy * history of heart failure, myocardial infarct (mi), bradyarrhythmias, conduction defects * history of asthma or reactive airway disease * history of thyroid disease * diabetes * renal insufficiency (bun \>21 mg/dl and/or creatinine \>1.4 mg/dl) * use during the screening or study period of any of the following medications: antihypertensives, diuretics, thyroid replacement therapy, anti-arrhythmia medications, bronchodilators, inhaled steroids, insulin, or hypoglycemic medication * history of allergy to sulfonamides

Keywords: sickle adhesion propranolol
comparative study between caudal epidural block and ultrasound guided transversus abdominis plane block for post operative analgesia in children undergoing infraumblical surgeries

Conditions: Post Operative Analgesia in Children Undergoing Infraumblical Surgeries

Summary: comparative study between caudal epidural block and ultrasound guided transversus abdominis plane block for post operative analgesia

comparative study between caudal epidural block and ultrasound guided transversus abdominis plane block for post operative analgesia in children undergoing infraumblical surgeries

Eligibility criteria:
inclusion criteria: - 120 children, aged between 4 and 7 years undergoing infraumblical surgeries as ( hypospadias , inguinal hernia and orchopexy ).patients will be selected according to asa physical status class i to ii from both genders who be able to swallow tablets. exclusion criteria: * parents' refusal. * urgent cases. * other contraindications of regional anesthesia (e.g. infection at injection site, coagulopathy and allergy to bupivacaine) * insulin dependent diabetes * thyroid disease
very small embryonic-like stem cells for erectile dysfunction

Conditions: Organic Erectile Dysfunction

Summary: the aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(vsels) to organic erectile dysfunction, such as those associated with metabolic syndrome or the treatment of prostate cancer.

by enrolling patients with organic erectile dysfunction adapted to enrolled criteria, this study will document for the first time the safety and efficacy of underlying penile cellular damage. the safety will be evaluated by tolerance degree. the efficacy will be evaluated validated scores and color duplex doppler ultrasound.

Eligibility criteria:
inclusion criteria: * metabolic and systemic changes in diseases such as diabetes and atherosclerosis or more localized causes such as direct injury to the penile neurovascular supply during prostate surgery * diagnosed as an organic erectile dysfunction by at least 2 urological surgeons exclusion criteria: * non-organic erectile dysfunction, such as psychological factors * solid cancer patients other than early prostate cancer * blood disease patients, thrombocytopenia or dysfunction, hypofibrinogenemia or anticoagulant therapy, long-term use of aspirin * older than 70 years

Keywords: erectile dysfunction very small embryonic-like stem cell
crossover blinded trial of cell therapy versus placebo in copd

Conditions: COPD; Emphysema or COPD; Chronic Bronchitis

Summary: the aim of this randomized, controlled crossover designed study is to compare the outcomes of receiving autologous, adult stem cells versus placebo among participants with chronic obstructive pulmonary disease (copd). the study is limited to self-funded participants with a diagnosis of copd. the study, along with others at the lung institute, have received full review and approval of an institutional review board.

the purpose of the lung institute is to collect, minimally process, and administer a person's own stem cells and/or platelet rich plasma and deliver the product back to the patient same-day through an intravenous catheter. this study is limited to patients diagnosed with chronic obstructive pulmonary disease (copd) and is a double-blinded prospective, cohort trial using cross-over methodology. the aim of this study is to determine if stem cell therapy is better than placebo among a group of patients with copd. 50 participants will be recruited for each arm of the study. cohort a will receive three days of cell therapy using the venous procedure (three consecutive days of blood harvest, cell separation and cell application). cohort a will return in three months and receive three consecutive days of placebo. cohort b will receive three consecutive days of placebo. cohort b will return in three months and receive three consecutive days of cell therapy using the venous procedure.

Eligibility criteria:
inclusion criteria: * patients are included in treatment by self-referral and after consultation with a designated patient coordinator who determines initial eligibility, and then by the clinic nurse practitioner or physician of lung institute who determines final eligibility for inclusion. patients must be diagnosed with chronic obstructive pulmonary disease (copd) and be able to travel to the dallas clinic location. exclusion criteria: * patients who are unable to provide informed consent, pregnant patients, prisoners, non-english speakers, patients with a history of cancer within the past 5 years, patients with active tuberculosis or pneumonia. patients without a documented copd diagnosis are excluded.
biomarkers of cardiovascular complications in chronic kidney disease

Conditions: Chronic Renal Disease

Summary: identification of new retention solutes associated with cardiovascular (cv) toxicity in chronic kidney disease (ckd) patients will help to better understand the pathophysiological mechanisms at stake and to prevent ckd-associated mortality and morbidity. for a molecule to be defined as a toxic retention solute, plasma accumulation in the course of ckd has to be demonstrated but also proof needs to be made that plasma accumulation during ckd is indeed associated with an increased risk of cv complications. moreover, precise determination of the plasma concentration has to be performed in order to later study in vitro and in vivo the toxic mechanisms involved. based on previous results of plasma proteome analysis using mass spectrometry, a previous study has selected 10 promising protein candidates. these proteins accumulated in the plasma of patients during ckd progression and are known to be associated with cv events in non-ckd patients. the objective of the present study is now to 1) evaluate the association of the plasma accumulation of the 10 retention solutes with cv complications in ckd patients and 2) determine their plasma concentration using elisa. one hundred and seventy six patients with advanced ckd will be included and divided in 2 groups: 44 patients with history of cv complications in the past 4 years and 132 patients free of any cv complications.


Eligibility criteria:
inclusion criteria: * patient with stage 4 or 5 ckd. exclusion criteria: * patient with stage 1, 2 or 3 ckd * patient with solid tumor * patient with malignant blood disease * patient with acute kidney disease in the past 3 months * patient with acute glomerulonephritis in the past 6 months.

Keywords: cardiovascular complications biomarkers
a new approach for catheter ablation of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this is a retrospective cohort study of radiofrequency ablation for the treatment atrial fibrillation(af). based on the electrophysiological phenomena found in these cases, the investigators propose a hypothesis regarding the underlying electrophysiological mechanism of af, as well as a novel approach for catheter ablation of af.

the investigators propose a new electrophysiological mechanism for af: the superposition hypothesis. the investigators tested this hypothesis by conducting the retrospective cohort study to determine if superposition potentials (sp) can identify the critical regions where af is sustained and if ablating sps can improves the long-term efﬁcacy. the study consecutively collected patients with underwent the first catheter ablation for symptomatic af in a university hospital from march 2021 to june 2022, including paroxysmal af (lasting \ 7 days and \ 1 year), aged between 18 and 80 years old. af recurrence was evaluated at 3, 6, 9, and 12 months using 72-hour holter monitoring at each clinic visit. the eligible patients were divided into two groups: the pulmonary vein isolation(pvi) alone group (n=56) and the pvi + sps ablation group(n=60).comprehensive clinical history and procedural data of patients were collected from electronic medical records.

Eligibility criteria:
inclusion criteria: * patients with underwent the first catheter ablation for symptomatic af exclusion criteria: * patients with more than one missing follow-up would be excluded