Kornimate/medical-research-clean huggingface dataset:
chg combined with venetoclax and azacytidine in newly diagnosed aml

Conditions: Acute Myeloid Leukemia

Summary: the goal of this phase 2 trial is to test the safety and efficacy of chg combined with venetoclax in treating patients with newly diagnosed aml.

the investigators will evaluate response rate of chg regimen combined with venetoclax in newly diagnosed acute myeloid leukemia. after induction therapy, patients will be given standardized treatment according to risk stratification according to nccn guidelines. progression free survival (pfs), overall survival (os), and toxicity will be counted.

Eligibility criteria:
inclusion criteria: * the patient should, in the investigator's opinion, be able to meet all clinical trial requirements. * the patient is willing and able to adhere to the study visit schedule and other protocol requirements. * the patient should be diagnosed with aml according to the standard criteria of the world health organisation (who). * the patient should not have received any prior treatment for aml. exclusion criteria: * active or uncontrolled infections requiring systemic treatment within 14 days before enrollment. * any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy. * pregnant or lactating women.
comparative performance of purevision, acuvue oasys and o2optix

Conditions: Myopia

Summary: the objective of this study is to evaluate the performance of the purevision contact lens compared to acuvue oasys contact lens and o2optix contact lens when worn on a daily wear basis.


Eligibility criteria:
inclusion criteria: * subject is myopic * va correctable to 0.3 logmar or better (driving vision) * clear central cornea * subject uses a lens care system on a regular basis exclusion criteria: * systemic disease affecting ocular health * using systemic or topical medications * wear monovision, multifocal or toric contact lenses * any grade 2 or greater slit lamp findings
neoantigen vaccine therapy against h3.3-k27m diffuse intrinsic pontine glioma

Conditions: Diffuse Intrinsic Pontine Glioma

Summary: diffuse intrinsic pontine gliomas (dipgs), which diffusely occupy the pons of brainstem, are the deadliest primary brain cancer in children. biopsy for pathology plus radiotherapy remains the current standard-of-care treatment that is minimal effective. thus, the median overall survival after diagnosis is just 10 months. recent studies have identified a lysine 27-to-methionine (k27m) somatic mutation at histone h3 variant (h3.3), as a feature mutation in dipgs. several preclinical studies have already demonstrated h3.3-k27m as a promising target for immunotherapy. the researched vaccine is a cancer-treatment vaccine containing an h3.3-k27m targeted neoantigen peptide, that can be taken up by antigen-presenting cells (apcs). apcs can present the peptide with the major histocompatibility complex (mhc) molecules on cell surface, thereby activating neoantigen-specific t cells and triggering corresponding cytotoxic t cell immune responses to eliminate h3.3-k27m-expressing dipg cells. the main goal of this study is investigating the safety and preliminary efficacy of the vaccine in treating newly-diagnosed dipgs when the vaccine is administered in combination with the standard-of-care treatment.


Eligibility criteria:
inclusion criteria: a. first entry criteria 1. age ≥ 5 years old; 2. newly-diagnosed patients with dipg appearance on mri image; 3. hla-a2 subtype; 4. the expected survival time exceeds 24 weeks; 5. the kps score is greater than 50; b. second entry criteria 1. the kps score is greater than 50; 2. dipg is diagnosed histologically on tumor tissue obtained by biopsy or surgical resection; 3. h3.3k27m mutation is detected on tumor tissue obtained by biopsy or surgical resection ; 4. adequate organ functions that meet the following criteria: the absolute number of neutrophils: ≥1500/mm3 platelet count: ≥75000/ul hemoglobin: ≥80 g/l creatinine≤1.5×uln bilirubin≤1.5×uln alt≤3×uln ast≤3×uln 5. ability to comprehend and sign an informed consent form. exclusion criteria: 1. with past medical history of malignant tumors (except being asymptomatic for more than 3 years); 2. history of allergy to chemotherapeutics or radiosensitizers for the treatment of cancer in central nervous system and head/neck; 3. history of allergy to the vaccine and its ingredients; 4. comorbidity with hiv infection and/or acute phase of hepatitis b/c; 5. any progressive diseases that hinder participation in the trial; 6. with unstable cardiovascular diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia et.al.; 7. history of uncontrolled mental illnesses; 8. inability to comprehend or sign informed consent form or abide by the research procedures; 9. other conditions believed to hinder participation in this trial at investigator' discretion.
retrospective/prospective data collection on the ldr roia interbody fusion device with vertebridge plating

Conditions: Degenerative Disc Disease

Summary: the purpose of this combination retrospective and prospective post market study is to examine the short term safety and efficacy of the roi-a® interbody fusion device with vertebridge® plates to treat single and two-level degenerative disc disease between l2 and s1, with a focus on fusion rates and patient outcomes.


Eligibility criteria:
inclusion criteria: * subjects must have degenerative disc disease (ddd) of the lumbar spine between l2 and s1 * subjects may have up to a grade 1 spondylolisthesis at the involved level(s) * subject must have the roi-a® device at one level or at two contiguous levels between l2 and s1 only * subject should have had a minimum of 6 months non-surgical treatment prior to receiving the roi-a® device * subject may have had no more than two previous non-fusion surgeries to the lumbar spine at the same levels as the roi-a® * subject must be at least 21 years of age at the time of surgery * subject must be willing to signed an informed consent document and return for a 12 month visit exclusion criteria: * subject had more than grade 1 spondylolisthesis at the operated level * subject is a prisoner. * subject was pregnant at the time of surgery. * subject had an active infection or sepsis at the time of surgery.

Keywords: ddd lumbar spine fusion rate degenerative disc disease
the comparison of tricuspid replacement and repair in patients with combined heart valve disease

Conditions: Tricuspid Valve Regurgitation

Summary: functional tricuspid regurgitation is common in patients with heart valve disease, replacement and repair both can correct this anomaly. however, there is no data to address which one can bring more benefits to these patients with combined heart valve disease. the investigators retrospectively review patients with two or more heart valve disease and functional tricuspid regurgitation, and assess its long term outcomes.

we reviewed patients who admitted to our hospital due to combined heart valve disease, and underwent tricuspid valve replacement or repair from january,1998 to december,2009. we made a comparison between these two groups, in term of early results after operation and long term results.

Eligibility criteria:
inclusion criteria: * significant disorders in aortic and mitral valves * moderate ～ severe tricuspid regurgitation * underwent tricuspid repair or replacement operation exclusion criteria: * isolate tricuspid valve lesion * mild tricuspid valve regurgitation * tricuspid valve regurgitation was left without surgical treatment

Keywords: tricuspid valve regurgitation replacement repair outcomes
non-invasive preeclampsia screening and biobank

Conditions: Preeclampsia (PE)

Summary: women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.

to collect relevant pregnancy outcome data, medical history, and blood samples from pregnant women carrying a singleton fetus undergoing non-invasive screening for early, preterm and term pre-eclampsia (pe) starting at 11 weeks 0 days to 14 weeks 0 days (≥11 - ≤14) gestation in support of validating the labcorp preeclampsia screentm assay. data will be used to examine assay performance and develop new testing methods.

Eligibility criteria:
inclusion criteria: * subject is female and 18 years of age and older; * subject provides a signed and dated informed consent; * subject is pregnant with a singleton pregnancy at ≥11.0 - ≤14.0 weeks' gestation; * subject agrees to provide the sponsor access to any prenatal and postnatal screening or diagnostic test results and supporting data; * subject agrees to have utapi calculated during their soc first trimester ultrasound and map collected at the first trimester soc visit; * subject agrees to provide up to 25ml of whole blood at each trimester visit; * subject agrees to provide relevant medical and pregnancy/postnatal information including outcome. exclusion criteria: * subject is unlikely to return for second and third trimester testing; * subject is unlikely to have pregnancy outcome data available; * previous sample donation under this protocol with the same pregnancy; * subject is participating in a blinded aspirin study or taking unknown doses of aspirin.

Keywords: preeclampsia pregnant
liposomal bupivacaine in benign soft tissue tumor resection

Conditions: Benign Neoplasm

Summary: liposomal bupivacaine (exparel) has been used as an adjunct to pain management in the perioperative setting. however, the efficacy of the drug has not bewen studied in patients with benign soft tissue tumor resections. the goal of the study is to see if exparel controls pain and improves functional outcomes for patients after these procedures compared to the current standard bupivacaine hcl.

liposomal bupivacaine (exparel) has been used as an adjunct to pain management in the perioperative setting. however, the efficacy of the drug has not bewen studied in patients with benign soft tissue tumor resections. the goal of the study is to see if exparel controls pain and improves functional outcomes for patients after these procedures compared to the current standard bupivacaine hcl. patients will be randomly assigned exparel or bupivacaine hcl intraoperatively during the tumor resection. the amount administered is based on the size of wound after tumor resection. the patients are then provided a pain diary in which they record the amount of pain medications taken, vas pain scores, and musculoskeletal and tumor society score (msts) for the first week postoperatively. the study will end once 140 patients have been enrolled. data will be analyzed comparing morphine equivalents, pain scores, and functional scores between the groups.

Eligibility criteria:
inclusion criteria: * all benign soft tissue tumors greater than one cubic cm * adults 18 years and older exclusion criteria: * pregnant females * women who are breastfeeding * less than 18 years old * malignant tumors * tumors smaller than 1 cubic cm * allergy to exparel * patients who are opioid dependent defined as patients on a long acting narcotic or who take more than 30 morphine equivalents per day * allergy to amide anesthetics * bone tumors * patients unable to comply with the study standards and follow up
intensity modulated radiotherapy with concomitant boost in breast cancer

Conditions: Breast Cancer; Radiation Toxicity

Summary: to assess feasibility of postoperative imrt with concomitant boost in moderate-high risk breast cancer in terms of late toxicity and local control

patients treated conservatively with moderate-high risk breast cancer were treated with imrt plus concomitant boost to surgical bed (up to a dose of 50 gy to whole breast and 60 gy to the tumor bed). aim of the study was to evaluate late toxicity and local control after this treatment compared with a historical control group (cg) of patients treated with 3d-conformal postoperative radiotherapy delivered with conventional fractionation.

Eligibility criteria:
inclusion criteria: * histologically confirmed invasive breast cancer (pt1-4) with at least one of these characteristics: 3 or more metastatic axillary nodes, pre or peri-menopausal status, close resection margins * breast conservative surgery exclusion criteria: * positive margins * distant metastases

Keywords: breast cancer radiotherapy cutaneous toxicity subcutaneous toxicity local control imrt
glycemic response in persons with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: this will be a randomized crossover design. the subjects will be randomized to one of six interventions on six separate study days, one week apart.


Eligibility criteria:
subject inclusion criteria all subjects must comply with all the following inclusion criteria: * age 20-75 years * type 2 diabetes controlled with diet or diet and metformin (glucophage) * hemoglobin a1c less than 9.0% * fasting blood glucose less than 180 mg * hematocrit levels within normal limits * having obtained his/her informed consent subject exclusion criteria subjects representing one or more of the following criteria are excluded from participation in the study. * abnormal thyroid function * creatinine \>2.0 mg/dl * potassium \<3.5 meq/l * gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting * currently unstable diabetes or under treatment for cancer, heart disease, renal disease * unable to give informed consent or follow instructions * current insulin therapy or insulin therapy within the past month * patient who are pregnant * allergies to milk, soy or any component of the test product * patient who in the investigators assessment cannot be expected to comply with treatment * currently participating or having participated in another clinical trial * patients with anemia
cd3/cd28 bead activated t-cells following chemo-immunotherapy in patients with chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: the purpose of this research study is to test whether giving t-cells (type of white blood cell that are also known as immune cells) that have been specially processed in the laboratory will help chronic lymphocytic leukemia (cll) patients' immune system return to normal faster after chemotherapy. this research study will also look into the ability of the lab to process the t-cells for infusion and the side effects of giving t-cells to patients with chronic lymphocytic leukemia (cll).

single arm, multi-center trial to evaluate the efficacy of administering cd3/cd28 stimulated t cells to chronic lymphocytic leukemia (cll) patients following treatment with fludarabine or alemtuzumab based chemo- immunotherapy. all patients will undergo an apheresis to collect peripheral blood mononuclear cells (pbmcs) for generation of expanded t cells post- chemo-immunotherapy. those subjects who achieve a complete or partial response to the chemoimmunotherapy based regimen will receive an infusion of 1.0 x 1010 (+/- 20%) activated autologous t cells expanded from the collected apheresis unit. prior to t-cell infusion, at day +30, +60, and +365 after t cell infusion, blood draws will be performed to assess immune reconstitution and immune function as compared to baseline.

Eligibility criteria:
inclusion criteria: * diagnosis of cll by immunophenotyping and flow cytometry analysis of blood or bone marrow. * patients with rai stage iii-iv - or - patients with rai stage 0-ii * zubrod performance status of 0-3 * prior treatment with fludarabine or alemtuzumab based regimens. * no untreated or uncontrolled life-threatening infection * women of childbearing potential must have a negative serum pregnancy test and agree to use a medically accepted form of contraception from the time of initial screening through completion of the study * no active cns disease * negative tests for hiv antibodies, hepatitis b surface antigen, and hepatitis c antibodies. exclusion criteria: * receipt of glucocorticoids (with the exception of inhaled glucocorticoid steroids for the use of allergic rhinitis or pulmonary disease) within 2 months prior to registration * history of autoimmune disease unrelated to cll (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis). autoimmune disease related to cll, e.g. idiopathic thrombocytopenic purpura (itp) or autoimmune hemolytic anemia, is permitted if not requiring active treatment

Keywords: chronic lymphocytic leukemia
understanding hemophilia a and b drug dosage administration patterns

Conditions: Hemophilia A; Hemophilia B

Summary: study design a prospective observational, cross-sectional epidemiological study in u.s. site-based clinical practice settings. 30 sites will enroll approximately 300 patients participating patients - or their caregiver in the case of patients under the age of 18 - will be consented to participate. physicians complete a retrospective chart review on each enrolled patient. patients will complete a one-time study questionnaire.

study recruitment was stopped due to difficulty in enrolling the targeted number of patients on march 21, 2018. subjects currently enrolled into the study have completed the study as per protocol. there were no safety concerns involved in the decision to stop enrollment.

Eligibility criteria:
physician/clinician participants: * must be a healthcare provider * currently manages at least 10 hemophilia a and/or b patients patient participants: * willing and able to provide informed consent * diagnosed with hemophilia a or b * current disease severity is either moderately severe or severe with a clotting factor level of ≤5% * if suffering from hemophilia a, must be currently taking moroctocog alfa (or another standard half-life treatment), rurioctocog alfa or efraloctocog alfa for at least six months. (if currently taking rurioctocog alfa or efraloctocog alfa, must have been switched from a standard half-life treatment and had been on that prior treatment for at least six months). * if suffering from hemophilia b, must be currently taking nonacog alfa or eftrenonacog alfa for at least six months (if currently taking eftrenonacog alfa, must have switched from nonacog alfa and had been on that prior treatment for at least six months). * infuse at least 3 times per month exclusion criteria: * female with hemophilia a or b * mild haemophilia a or b

Keywords: hemophilia a factor viii hemophilia b factor ix cross-sectional epidemiological clinical practice united states
non-invasive measures of distal lung disease in asthmatics

Conditions: Asthma

Summary: this is a phase 4, single center study conducted in mild-to moderate asthmatics.

the study consists of 3 phases. there are 7 study visits.

Eligibility criteria:
inclusion criteria: * 18-65 years old * currently using saba prn or a low-to-moderate persistent asthma exclusion criteria: * tobacco use within 1 year or \>= 5 pack years
bm-mnc and ucmsc for type 2 diabetes mellitus patients

Conditions: T2D

Summary: the aim of this preliminary study is to evaluate the safety and efficacy of bone-marrow mononuclear cells (bm-mncs) and umbilical-cord tissue-derived mesenchymal stem cells (uc-mscs) administration in type 2 diabetes patients

type 2 diabetes (t2d) patients had peripheral insulin resistance accompanied by progressive pancreatic beta cell degeneration and dysfunction due to glucotoxicity and lipotoxicity. several studies have shown that the immune system plays a significant role in the pathogenesis of t2d. bone-marrow mononuclear cells (bm-mncs) and umbilical-cord tissue-derived mesenchymal stem cells (uc-mscs) via its immunomodulatory properties have the potential to improve insulin resistance condition and pancreatic beta-cells dysfunction thus improve the glycemic control and insulin requirement in t2d patients. in this pilot study, we plan to recruit 15 t2d patients with total daily dose of insulin \>= 0.5 unit/kgbw/day to receive bm-mncs (5 subjects) or uc-mscs injections (10 subjects). these subjects will be closely followed up for 12 months for evaluation of primary and secondary outcome.

Eligibility criteria:
inclusion criteria: * type 2 diabetes patients on insulin therapy with or without oral hypoglycemic agents, with total daily dose of insulin \>= 0,5 unit/kg body weight * stable hba1c in the last six months (hba1c \<= 8.5%) exclusion criteria: * type 1 diabetes mellitus * egfr \< 45 ml/min/m2 (for bm-mnc) * liver disease (moderate- severe) * active infection * contrast hypersensitivity (for bm-mnc) * history of malignancy * acute coronary syndrome in last three months * coronary arterial diseases with significant stenosis and has not carried out revascularization * pregnancy (for women subjects)

Keywords: type 2 diabetes bone-marrow mononuclear cells umbilical cord mesenchymal stem cells glycemic control
study to evaluate the safety and effectiveness of saxenda® for weight management in routine clinical practice in taiwan.

Conditions: Obesity

Summary: this is a non-interventional study to evaluate the safety and effectiveness of saxenda® in obese adults and adolescents in taiwan. the participants will recieve saxenda® treatment which is a medicine that doctors can already prescribe. the study will last for about 26 weeks.


Eligibility criteria:
inclusion criteria: 1. male or female of taiwanese patients, age above or equal to 12 years who are under saxenda® treatment or are scheduled to treat with saxenda® according to approved label in taiwan based on the clinical judgment of their treating physician. 2. patients should have baseline (pre-dosing) values, including body height, weight and initial dosage of saxenda® . 3. the decision to initiate treatment or to have started with commercially available saxenda® has been made by the patient/legally acceptable representative (lar) and the physician independently from the decision to join this study. 4. informed consent obtained before collection of clinical data for this study. study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. exclusion criteria: 1. known or suspected hypersensitivity to saxenda® , the active substance or any of the excipients 2. previous participation in this study. participation is defined as having given informed consent in this study. 3. treatment with any investigational drug within 30 days prior to initiation of saxenda® treatment. 4. female patient who is pregnant, breast-feeding, or intends to become pregnant. 5. patients with a personal or family history of mtc or in patients with multiple endocrine neoplasia syndrome type 2 (men 2). 6. mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation
study protocol/ registry of multipoint™ pacing in brazil

Conditions: Heart Failure, Unspecified

Summary: this is a prospective, multicenter, non-randomized registry/observational study. the study will enroll up to 200 patients with successful st. jude medical (sjm) cardiac resynchronization therapy (crt) mp device implant from up to 10 centers.

any patient receiving a market-approved sjm quadra assura mp (crt-d) or newer model quadripolar device with mpp capability and who meets the inclusion criteria and none of the exclusion criteria is eligible for enrollment in the study. patients will be followed for 12 months after implant. data will be collected after device implant (up to 30 days after successful implant), at 3, 6 and 12 months post-implant and during unscheduled visits.

Eligibility criteria:
inclusion criteria: * patient willing and able to sign informed consent form * any patient receiving a market-approved sjm quadra assura mp (crt-d) or newer model quadripolar device with mpp capability exclusion criteria: * is likely to undergo a heart transplantation within 12 months * is less than 18 years old * is pregnant or is planning to get pregnant during the study * is currently taking part in a clinical trial with an active treatment group * life expectancy is under 6 months

Keywords: multipoint pacing heart failure cardiac resynchronization therapy quadripolar pacing