Kornimate/medical-research-clean huggingface dataset:
a study to evaluate pf-04449913 with chemotherapy in patients with acute myeloid leukemia or myelodysplastic syndrome

Conditions: Acute Myeloid Leukemia

Summary: this is a study to evaluate pf-04449913 (an inhibitor of the hedgehog pathway) in acute myeloid leukemia and high-risk myelodysplastic syndrome in combination with standard agents used to treat these diseases.


Eligibility criteria:
inclusion criteria: * patients with aml or raeb 2 high risk mds who are newly diagnosed according to the who 2008 classification and previously untreated. * patients with aml (arising from an antecedent hematologic disease \[ahd\]) or mds who may have had one prior regimen with commercially available agents for the treatment of their prior hematologic disease. the patients may not have had a prior therapy for their aml. * aml patients include de novo aml, aml evolving from mds or other ahd and aml after previous cytotoxic therapy or radiation (secondary aml) * for a diagnosis of aml, a bone marrow blast count of 20% or more is required. * for a diagnosis of high-risk myelodysplastic syndrome raeb 2 the patient must have 10-19% bone marrow blasts * adequate organ function * ecog performance status 0, 1, or 2 exclusion criteria: * aml m3 acute promyelocytic leukemia (apl) or patients with a t(9:22) cytogenetic translocation. * patients with known active uncontrolled central nervous system (cns) leukemia.

Keywords: hedgehog inhibitor acute myeloid leukemia myelodysplastic syndrome intensive chemotherapy ldac glasdegib
determining the impact of distance reiki on patient reported qol and immunity among multiple myeloma patients

Conditions: Multiple Myeloma; Autologous Stem Cell Transplant

Summary: this research study is being done to determine if distance reiki therapy offers a quality of life benefit, and improves immunity compared to patients receiving sham distance reiki therapy or no additional reiki intervention.

reiki is a popular complementary medicine modality sought after by patients. this non- intrusive japanese based therapy centers on the guiding of energy through a reiki practitioner to the patient which facilitates innate healing by modulation of energy fields. reiki is formally classified as biofield therapy by the national center for complementary and alternative medicine (nccam). current research indicates that reiki shows promise as a noninvasive healing tool for mind and body, particularly among patients with cancer. however, the data validating the effectiveness of reiki integrated within a structured medical paradigm and the effect on cancer immunity remains unknown. given the clear demand for reiki among cancer patients but skepticism within the medical community, this trial will aim to determine an objective patient reported quality of life (prqol) benefit by utilizing validated tools, in order to effectively implement reiki into traditional medical practice. multiple myeloma patients are at high risk of serious illness from the covid-19 virus during this pandemic, and so distance reiki will be carried out via video conferencing platform.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients with multiple myeloma with stable disease or currently in maintenance therapy * english speaking * computer and internet access with video conferencing availability exclusion criteria: * evidence of disease relapse at the post-transplant follow up visit * patient not returning to mayo clinic rochester for subsequent post-transplant follow up
clinical study of depodur efficacy in decreasing post operative pain after off pump coronary artery bypass grafting (op-cabg)

Conditions: Pain, Postoperative

Summary: the purpose of this study is to determine whether epidural depodur alleviates the pain of op-cabg surgery. this includes pain associated with sternotomy, retraction, dissection and other tissue insults, as well as the induced inflammatory system and effects from prolonged ventilation in the icu setting.

the purpose of this study is to determine whether epidural depodur alleviates the pain of op-cabg surgery. this includes pain associated with sternotomy, retraction, dissection and other tissue insults, as well as the induced inflammatory system and effects from prolonged ventilation in the icu setting. it will be compared to placebo.

Eligibility criteria:
inclusion criteria: * male or female, 18-99 years old * all patients who will have surgery for op-cabg exclusion criteria: * pregnant females * patients with allergy to morphine * patients nursing an infant * patients with migraine headaches * patients taking coumadin within 7 days or demonstrating inr \> 13 * patients taking heparin unless documented normal partial thromboplastin time * patients taking clopidogrel in previous 7 days * patients taking ticlopidine in previous 14 days * patients taking aspirin in previous 48 hours * patients receiving low molecular weight heparin therapy within 24 hours previous * patients with narcolepsy and/or sleep apnea * patients on chronic opioid therapy * patients participating in another study

Keywords: op-cabg depodur traditional drug
simulated comparison of standard versus rotational laryngeal mask airway insertion in novice anaesthesiologists.

Conditions: Training Group, Sensitivity

Summary: the primary objective of study was to compare insertion ease by standard and rotational lma insertion technique on basis of lma insertion attempts and insertion time duration. the secondary objective of study was to analyse impact of prior information for airway device, insertion techniques, general or specific work experience in airway management with ease of both insertion techniques. and, tertiary objective of study was to analyse the trainee's preference insertion technique on basis of learning method and practical adaptability. hypothesis: the rotational lma insertion technique is easy to understand and practice than the standard lma insertion technique at the beginning of airway management training among the novice anesthesiologists. hypothesis: the rotational lma insertion technique is easy to understand and practice than the standard lma insertion technique at the beginning of airway management training among the novice anesthesiologists.

* lma insertion attempts are the number of lma insertion attempts with each study's insertion technique. the 10 insertion attempts will be performed with each insertion technique by trainees. * lma insertion time duration is the time taken to complete lma insertion; from the holding of device till the confirmation of chest movement (artificial lungs inflation in manikin). * the correlation of previous information for airway device, insertion techniques, general or specific work experience in airway management with the ease of both study's insertion techniques will be asked by participant's through the questionnaire at the start of study. * the trainees will be asked at the end of study for preferred insertion method at novice level on the basis of learning method and practical conduct (user friendly)

Eligibility criteria:
inclusion criteria: * first year anaesthesia trainee * using adult mannequin exclusion criteria: * paediatric mannequin * participant's refusal

Keywords: lma technique standard rotational simulation
new anticoagulation strategies of vv-ecmo

Conditions: Hemorrhage

Summary: effective and normative anticoagulation is one of the most important components of extracorporeal membrane oxygenation (ecmo) management. excessive anticoagulation may lead to hemorrhage, which is the most common and serious complication. currently, the most common factors for monitoring anticoagulation of ecmo are the activated clotting time (act) and activated partial thromboplastin time (aptt). however, there is a lack of a unified understanding of the related monitoring measures, monitoring targets, and bleeding risk assessments, which have been chosen mainly because of experiences reported by various ecmo centers or the results of retrospective studies.therefore, anticoagulation strategies need to be improved. our research have found ecmo anticoagulation management should be transformed from monitoring only the aptt/activated clotting time (act) to considering the entire coagulation process. to maintain thrombosis ability and plt function within normal ranges may help reduce hemorrhage rates and improve prognoses. this randomized controlled study aim to develop the safety and efficacy new anticoagulation strategies of vv-ecmo.


Eligibility criteria:
inclusion criteria: * age more than 18 years old, vv-ecmo is estimated more than 3 days exclusion criteria: * hemorrhage before vv-ecmo established, vv-ecmo more than 48 hours before admitted, vv-ecmo is estimated less than 3 days
efficacy and tolerability of a new oral extended-release formulation containing parnaparin sodium, administered add-on therapy

Conditions: Ulcerative Colitis

Summary: the objective of this study is to evaluate the efficacy and the tolerability of oral parnaparin sodium (210mg), administered in extended-release tablets identified as cb-01-05-mmx™.


Eligibility criteria:
inclusion criteria: 1. male and female patients, between 18 and 70 years of age. 2. patients with a confirmed diagnosis of ulcerative colitis in treatment with fixed-dose of oral mesalazine or other 5-asa derivatives for at least 4 weeks with a high clinical suspicion of active disease, confirmed by sigmoidoscopy at enrolment in the study . 3. presence of ulcerative colitis located at left side of the colon, from splenic flexure of the colon to the rectum (up to 15 cm proximal to the anus). 4. patients with mild to moderate active ulcerative colitis, as defined by the dai ≥ 4 and ≤ 10, and cai ≥ 5 and ≤ 12. 5. women with negative serum test for pregnancy. 6. women of childbearing potential provided they use adequate contraceptive precautions during the treatment period. adequate contraceptive methods are defined as those with a failure rate \<1% per year when correctly used, and include implants, injectables, combined oral pills, some iuds or a vasectomised partner in a stable relationship. 7. ability to understand and willing to sign the informed consent form, and other documents required to be read or signed by the subject. exclusion criteria: 1. presence of other clinically significant medical condition as determined by the investigator. 2. history of hypersensitivity or idiosyncratic reaction to heparins. 3. history of hemorrhages, excluding intestinal bleeding due to ulcerative colitis, hemocoagulative disorders, or platelet dysfunction. 4. presence of arterial hypertension (sap ≥ 160 mm hg; dap ≥ 95 mm hg). 5. receipt of any investigational agent within 90 days of starting treatment. 6. use of rectal 5-asas or rectal corticosteroids within 2 weeks before the starting the study. 7. use of anti-tnf agents or immunosuppressive drugs such as azothioprine, 6-mercaptopurine or cyclosporine a in the last 3 months. 8. patients with ulcerative colitis of severe entity (dai \> 10 or cai \> 12), or with limited distal ulcerative proctitis, or with infectious colitis confirmed by microbiological assessment in stool. 9. patients with severe intestinal bleeding, or with hb \< 9 g/dl. 10. presence of significant hepatic impairment (ast, alt \> 2 uln). 11. presence of significant renal impairment (creatinine \> 2 uln). 12. women who are pregnant or who are breast feeding. 13. intestinal obstruction. 14. presence of type 1 or type 2 diabetes. 15. concomitant oral antibiotic treatment, within 2 weeks before starting the study.

Keywords: ulcerative colitis left-sided, mild to moderate ulcerative colitis
non-caloric sweeteners levels in breast milk and newborn's blood and effect on microbiota's composition.

Conditions: Microbial Colonization

Summary: this study evaluates the presence and quantity of non-caloric sweeteners in newborns umbilical cord blood, and in their mother's breast milk at delivery, at 2 months, 4 months and 6 months of age. microbiota composition will be evaluated in milk and in feces of both mother and child.

the consumption of non-caloric sweeteners (enc) is increasingly common in our country due to its wide use in all types of food and beverages, even those not labeled as "diet". despite its widespread use and being an alternative to the consumption of sugars, several studies have shown that frequent enc users are also at risk of excessive weight gain, type ii diabetes, and cardiovascular diseases. in addition to this, the consumption of enc in the early stages of life may predispose to the development of metabolic disorders later in life.the enc have been shown to have effects on the health of those who consume them, causing metabolic disorders, weight gain and changes in the microbiota. the newborns, in whom gut microbiota is in the process of being established, influenced by the vaginal and intestinal microbiota of the mother, as well as by the mother's milk, are a vulnerable population in whom the effect of enc consumption has not been investigated. this makes it relevant to study the prevalence of enc in breast milk and umbilical cord blood of their newborns and to evaluate the composition of the intestinal and milk microbiota in order to identify changes attributable to the consumption of enc.

Eligibility criteria:
inclusion criteria: * age 18-40 years old * women in labor * consent to participate in the study exclusion criteria: * pre-term delivery (\<30 weeks) * metabolic diseases (insulin resistance, diabetes, gestational diabetes) * hypertension * thyroid disease * cancer

Keywords: non-caloric sweeteners microbiota breast milk umbilical cord
passive cooling versus blanket-roll iii on the myocardial function of asphyxiated neonates

Conditions: Hypoxic Encephalopathy; Birth Asphyxia; Neonatal Encephalopathy; Hypothermia, Newborn

Summary: studying the effect of passive versus blanket roll iii modality of therapeutic hypothermia (th)on myocardial function of asphyxiated neonates through using tissue doppler (td).

a clinical trial study of 100 gestational-age-matched asphyxiated cooled neonates will divided into two groups, 50 in each group for comparison the myocardial function using passive cooling and blanket roll iii as modality of th.

Eligibility criteria:
inclusion criteria: * evidence of perinatal/intrapartum hypoxia, as indicated by at least one of: * apgar score of less than or equal to 5 at 10 minutes * needing mechanical ventilation or ongoing resuscitation at 10 minutes * ph in cord blood gas is less than 7.00 or a base excess worse than or equal to minus 12 mmol /l on cord/arterial/venous/capillary blood gas obtained within 60 minutes of birth. * evidence of moderate or severe encephalopathy. * greater than or equal to 35 weeks gestational age. * birth weight greater than or equal to 1800 g. * able to begin cooling before 6 hours of birth. exclusion criteria: * congenital cyanotic heart disease. * multiple congenital anomalies. * birth asphyxia's babies after start of cooling with cardiovascular instability.

Keywords: therapeutic hypothermia asphyxiated neonates tissue doppler
simvastatin therapy in women with polycystic ovary syndrome.

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of this study is to determine whether statins (simvastatin) improve clinical (excessive hair, skin problems), endocrine (androgens) and metabolic (lipids, markers of systemic inflammation) in women with polycystic ovary syndrome (pcos).


Eligibility criteria:
inclusion criteria: * pco - eshre/asrm criteria: oligomenorrhea (\ 70ng/dl) * normal prolactin, tsh, 17-oh progesterone * no evidence of androgen producing malignancy, cushing's syndrome or acromegaly * age 18-40 * reliable use of birth control pill for at least 3 months and no plans of pregnancy exclusion criteria: * elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminases) above 2 times of upper limit of normal * use of any of the following medications: cyclosporine, fibrates, niacin, antifungal agents, macrolide antibiotics. * use of oral contraceptives and other steroid hormones 3 months prior to the study * contraindications to oral contraceptives

Keywords: pcos statin testosterone lipids
genetic variants associated with the risk of gall stones and cirrhosis.

Conditions: Liver Cirrhosis; Gall Stone

Summary: gall stone disease is more common in patients with cirrhosis. this association has been well established in different studies. among the various factors which predispose a patient with gall stone disease to have associated liver cirrhosis, genetics also plays an important role. this study aims to do a genetic panel-based analysis of genes which are involved in cholestasis to find any association between liver cirrhosis and gall stone disease. patients with history of gall stone or history of cholecystectomy done for gall stone disease will be evaluated for the presence of liver cirrhosis by fibroscan and ultrasonography. those patients with cirrhosis and without cirrhosis will undergo a panel based genetic test for the common cholestasis genes and multivariate analysis will be done for variants associated with lithogenesis and cirrhosis.

study population: * patients \> 18 years of age. * who have either gall stone disease or cirrhosis. study design: all consecutive in-patients and out-patients requiring liver biopsy for evaluation of diffuse parenchymal liver disease will be evaluated for inclusion. study period: 1 year. intervention: blood sample from included patients will be subject to panel based ngs. monitoring and assessment: history of all patients including family history will be taken. screening for cirrhosis will be done by fibroscan or ultrasound scanning. gall stone diagnosis is made by usg. history about patients' parents, siblings, spouse, children will be taken with respect to gall stone and cirrhosis. ngs of cholecystitis will be send for the subject and the results will be collected as the fastq file for analysis. statistical analysis: mva will be done to identify gene variants independently associated with lithogenesis and cirrhosis, along with demographic and environmental risk factors for these conditions. \* from this data, overlapping risk-variants in common associated genes will be identified. a risk estimate (or with 95% ci) will be calculated for each of the above identified genetic risk variant for the phenotype of cirrhosis with gs. adverse effects: there are no adverse outcomes with respect to this study. stopping rule of study: there are no stopping rules for the study.

Eligibility criteria:
inclusion criteria: 1. patients \> 18 years of age. 2. who has a gsd diagnosed by usg or have history of cholecystectomy for gall stone disease. 3. who is a diagnosed case of cirrhosis by fibroscan or usg (cirrhosis including alcohol related cirrhosis, hepatitis b, hepatitis c, wilsons disease, hemochromatosis are excluded. exclusion criteria: 1. patients who have haemolytic anaemia 2. patients who do not consent for genetic study 3. patients who has a diagnosed cause for liver disease, including alcohol related cirrhosis, hepatitis b, hepatitis c, wilsons disease, hemochromatosis. 4. inability to provide informed consent. 5. cannot understand hindi or english should be excluded since they will not be able to reply objectively to questionnaire.
perillyl alcohol in treating patients with metastatic prostate cancer that has not responded to hormone therapy

Conditions: Prostate Cancer

Summary: rationale: drugs used in chemotherapy use different way to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of perillyl alcohol in treating patients with metastatic prostate cancer that has not responded to hormone therapy with androgens.

objectives: i. evaluate the clinical effectiveness of oral perillyl alcohol given to patients with androgen independent metastatic prostate cancer. ii. assess the toxicity of this treatment in these patients. outline: patients receive oral perillyl alcohol 4 times a day for 4 weeks. patients continue treatment in the absence of severe toxicity and disease progression. patients are followed every 3 months for survival after disease progression. projected accrual: this study will accrue 20-40 patients in approximately 2 years.

Eligibility criteria:
disease characteristics: histologically confirmed progressive metastatic or progressive regional nodal adenocarcinoma of the prostate regression of tumor following hormone therapy if on antiandrogen therapy, must fail to respond to withdrawal or have progressive disease following withdrawal of antiandrogen no cns disease patient characteristics: age: not specified performance status: wccc 0-2 life expectancy: at least 3 months hematopoietic: wbc at least 3000/mm3 absolute neutrophil count at least 1200/mm3 platelet count at least 100,000/mm3 hemoglobin at least 8 g/dl hepatic: bilirubin no greater than 1.5 mg/dl sgot no greater than 2.5 times normal renal: creatinine no greater than 1.5 times upper limit of normal other: at least 5 years since prior malignancy other than: inactive nonmelanoma skin cancer adequately treated stage i or ii cancer in complete remission no other serious illness no spinal cord compression symptoms prior concurrent therapy: biologic therapy: not specified chemotherapy: prior chemotherapy required endocrine therapy: failed one secondary hormonal manipulation for metastatic disease concurrent testicular androgen suppression (lhrh) allowed no concurrent hormonal therapy other than lhrh agonist at least 4 weeks since antiandrogen treatment in order to evaluate for response withdrawal radiotherapy: at least 4 weeks since prior radiation therapy no prior strontium therapy surgery: no prior orchiectomy other: no concurrent cholesterol lowering agents no concurrent supplemental vitamins no concurrent antioxidants

Keywords: recurrent prostate cancer