Kornimate/medical-research-clean huggingface dataset:
ma+aza regimen for the treatment of newly diagnosed acute myeloid leukemia (aml)

Conditions: Acute Myeloid Leukaemia

Summary: investigator proposed to apply the new dosage form of mitoxantrone hydrochloride liposomes to the clinical treatment of aml, while combining with cytarabine and azacitidine to form the ma+aza treatment regimen(mitoxantrone liposome +ara-cytarabine+azacitidine), which would provide an optimal induction treatment regimen for patients with primary aml by comparing with the traditional chemotherapy regimen, da+aza (daunorubicin+ara-cytarabine+azacitidine).

in this study, aml patients were randomly divided into ma+aza treatment group and da+aza treatment group by conducting a prospective, multicentre, exploratory, randomised controlled study. by observing the efficacy and safety of the ma+aza combination regimen in the treatment of primary aml, and comparing the superiority of the traditional regimen, high-quality clinical evidence was obtained, providing practical evidence to support the improvement of the intervention effect and clinical prognosis of primary aml.

Eligibility criteria:
inclusion criteria: 1. patients with primary aml with morphologically and immunologically confirmed diagnosis of bone marrow; 2. age 18-75 years old; 3. liver and renal function: serum total bilirubin ≤1.5 × upper limit of normal (uln), ast/alt \<2 × uln, serum creatinine \<1.5 × uln, 80 ml/min ≤ creatinine clearance ≤120 ml/min; 4. cardiac function: ejection fraction ef ≥50%, ultrasensitive troponin and natriuretic peptide \<1.5 × uln; 5. physical condition: ecog score 0-2; 6. obtained informed consent signed by the patient or family. exclusion criteria: 1. allergy or significant contraindication to any of the drugs involved in the protocol; 2. patients with concomitant myelofibrosis; 3. severe cardiac disease, including myocardial infarction and cardiac insufficiency; 4. concomitant malignant tumours of other organs; 5. patients with active tuberculosis and hiv-positive patients; 6. other blood system diseases at the same time; 7. pregnant or breastfeeding women; 8. inability to understand or comply with the study protocol; 9. previous intolerance or allergy to similar drugs; 10. concurrent participation in other clinical studies; 11. any other condition that prevents the study from proceeding.

Keywords: mitoxantrone liposome newly diagnosed aml patients ara-cytarabine azacytidine
the mechanism for the effects of joint biomechanical properties on medial cartilage of tibiofemoral joint degeneration

Conditions: Anterior Cruciate Ligament Injuries; Cartilage Degeneration

Summary: explore the mechanism for the effects of joint biomechanical properties on medial cartilage of tibiofemoral joint degeneration

cartilage degeneration in the medial tibiofemoral joint is common after anterior cruciate ligament reconstruction (aclr), which may develop into knee osteoarthritis (disability rate 21.3%). alterations in joint biomechanical properties play an important role in cartilage degeneration after aclr. however, the mechanism remains unclear. our research studied the joint kinematics and kinetics properties after aclr and found significant changes in biomechanics in the aclr knees. therefore, this study will combine longitude biochemical changes in the cartilage to explore how the alterations in biomechanics would influence biochemical changes in the joint cartilage. this study will explore the joint biomechanical properties during functional activities by motion analysis, the effects of biomechanical properties on cartilage stress distribution by finite element analysis, the long-term biochemical changes in the joint cartilage by functional mri. this study will establish prediction models for cartilage biomechanical changes in the mid-term based on joint biomechanical properties in the early stage after aclr, and cartilage biomechanical changes in the long-term based on joint biomechanical properties in the mid-term after aclr. the study aims to clarify the mechanism of cartilage degeneration after aclr and search biomechanical risk factors, in order to provide methods for clinical prevention of cartilage degeneration after aclr.

Eligibility criteria:
inclusion criteria: unilateral acl rupture of the knee exclusion criteria: concomitant with other ligament injury or rupture, with history of surgery or musculoskeletal system injury of the contralateral knee, and the time from injury to operation more than 8 weeks

Keywords: sports biomechanics joint loading anterior cruciate ligament reconstruction cartilage degeneration functional mri
pregabalin for abdominal pain from adhesions

Conditions: Abdominal Pain; Surgical Adhesions

Summary: the purpose of this study is to evaluate if pregabalin demonstrates significant reduction in abdominal pain from adhesions.

the study will be prospective, double-blinded and randomized. the study will run for 12 weeks. during the first 7 weeks there will be 2 groups in the study with subjects receiving a placebo or the study drug. during the last 4 weeks of the study, all subjects will be offered the study medication, pregabalin. the primary outcome measure will be pain relief documented by a 2-point change on the likert pain scale with a secondary pain measure of sleep interruption.

Eligibility criteria:
inclusion criteria: * must have history of prior surgery and documented adhesions during laparoscopy or open laparotomy within 5 years * must have undergone an evaluation to exclude other causes of abdominal pain * abdominal pain must be present for greater than three months duration exclusion criteria: * patients that are pregnant or breast feeding * prior treatment with gabapentin, pregabalin or demonstrated sensitivity to these drugs * patients who are immunocompromised * patients with significant hepatic or renal insufficiency, or any significant hematologic disorder * history of illicit alcohol or drug abuse within one year * documented serious or unstable medical or psychological condition * malignancy within the past 5 years other than in situ squamous cell carcinoma of the skin

Keywords: abdominal pain surgical adhesions
inactive hbsag carriers (ihcs) treated with pegylated interferon α2b based intervention therapy

Conditions: Chronic Hepatitis B

Summary: a single center, randomized controlled trial design was used to select patients with chronic hepatitis b in the immune control period (hbsag positive, hbeag negative, normal alt, hbsag ≤ 1500iu/ml, hbv dna ≤ 2000iu/ml) to enter the study, and to compare the feasibility, effectiveness and safety of pegylate combined with granulocyte-macrophage colony stimulating factor, high-dose hepatitis b vaccine and pegylate monotherapy in the treatment of patients with chronic hepatitis b in the immune control period

explore the efficacy, safety and related influencing factors of intervention therapy based on pegifn α- 2b in inactive hepatis b surface antigen (hbsag) carriers (ihcs), and compare pegifn α- 2b combined with granulocyte macrophage stimulating factor (gm-csf), high-dose hepatitis b vaccine and pegifn α- 2b feasibility, efficacy and safety of monotherapy for ihcs.the ihcs patients were randomly divided into two groups (group a: pegifn α- 2b single drug group, group b: pegifn α- 2b combined with gm-csf and high-dose hepatitis b vaccine group). to start applying pegifn α- 2b was the baseline, treatment for 68 weeks, followed up for 24 weeks after drug withdrawal. patients in group b used gm-csf and vaccine introduction for 16 weeks before baseline.the hbsag clearance rate and related influencing factors of the two groups at 68 weeks were analyzed.

Eligibility criteria:
inclusion criteria: * age 18 to 65 years; * hbsag seropositive status for more than 6 months prior to enrollment; * never received treatment with any form of nucleos(t)ide analogues (nas) or interferon before enrollment; * serum hbsag ≤1500 iu/ml; * hbeag negative with or without hbeab positive; * serum hbv dna ≤2000iu/ml iu/ml; * normal alt levels; * normal white blood cell and platelet counts; * abdominal computed tomography or b-ultrasound showed no cirrhosis, splenomegaly or ascites. exclusion criteria: * participants with other hepatotropic viruses or human immunodeficiency virus co-infection * other chronic non-viral liver diseases or decompensated liver diseases * tumours * drug abuse * severe psychiatric disease * uncontrolled thyroid disease or diabetes * pregnancy or lactation

Keywords: inactive hepatitis b virus carriers hbsag clearance peginterferon alpha 2b intervention treatment
evaluation of the dpp hiv 1/2 test and the hiv 1/2 stat pak test using oral fluid

Conditions: HIV Infections

Summary: this protocol is intended to test the feasibility of using the hiv 1/2 stat-pak and the dpp hiv 1/2 test (with and without the dpp handheld reader) to detect hiv antibodies in oral fluids.

the objective of this study is to evaluate the feasibility of using fresh oral fluid specimens, from known hiv-positive individuals, to test for hiv-1 antibodies using both the dpp hiv 1/2 and hiv 1/2 stat-pak tests. two oral fluid collection devices will be used and compared (mpc and chembio collection devices) and the results obtained from oral fluids will be compared with those obtained from whole blood and plasma using paired samples from the same participants. the comparison between oral fluid, whole blood and plasma will be made in both chembio devices (hiv 1/2 stat-pak and dpp hiv 1/2).

Eligibility criteria:
inclusion criteria: * participants with known hiv infection who are willing to participate in the study and who sign an informed consent (or assent), will be included in the study. * patients on haart treatment for hiv will be included, but this information as well as the dates (duration) of treatment will be obtained through the interview of study participants; a medical record review is not necessary or required. the study participant's responses will be recorded by study staff on a data collection form. * patients with immunosuppressive conditions other than hiv will be included if available, but will be limited to \< 25% of the total test population. immunosuppression will also be assessed through interview of study participants and/or through verbal confirmation by the treating physician; a medical record/chart review is not required. * patients must be willing to undergo venipuncture to donate one tube of edta whole blood (not more than 10cc), and to provide three oral fluid samples. exclusion criteria: * patients who do not consent, withdraw consent, or for whom the investigator determines that venipuncture or gum swabbing may create a health risk will be excluded from the study. * participants who have been enrolled in hiv vaccine studies will be excluded from the study. this will be ascertained through interview of study participants. * participants who have been enrolled once in this study will be excluded from repeat enrollment. * participants must not have introduced any substance into their oral cavity (gum, food, beverage, candy, lozenges, mouthwash, etc.) for 30 minutes prior to providing an oral fluid sample. this will be ascertained through interview of study participants.

Keywords: hiv-1 infections
comprehensive assessment on diagnostic and prognostic performance of coronary physiological indices

Conditions: Coronary Artery Disease

Summary: the objective of the zhongshan hospital concorde registry is to evaluate utility, diagnostic value, and clinical outcomes of coronary physiological indices in an all-comers population of patients with suspected coronary artery disease referred to invasive coronary angiography in order to further inform patients and health care providers about which technologies are most effective and efficient in the diagnosis and management of coronary artery diseases.

concorde registry offers a comprehensive pressure and/or flow measurements, as well as angiography-derived functional assessment of coronary. patient treatment was at the operator's discretion at the time of the invasive procedure. a standardized data collection sheet was used and data were extracted from electrical medical history according to standardized definition of patient's baseline characteristics, clinical outcomes, and physiologic data.

Eligibility criteria:
inclusion criteria: * suspected coronary artery disease * referred to invasive coronary angiography exclusion criteria: * hemodynamic instability
18f-mfbg pet/ct in the evaluation of neural crest tumor

Conditions: Neuroendocrine Tumor; Neuroblastoma; Pheochromocytoma; Paraganglioma

Summary: the aim of this study is to evaluate the diagnostic performance and tumor burden of 18f-metafluorobenzylguanidine (18f-mfbg) positron emission tomography (pet) in patients with neuroendocrine tumors mainly in pheochromocytoma and paraganglioma (ppgl) and neuroblastoma (nb).

pheochromocytoma and paraganglioma (ppgl) and neuroblastoma (nb) highly express norepinephrine transporter (net) which is targeted by functional analogue of norepinephrine, 131i/123i-mibg. however, low spatial resolution of 123/131i-mibg and inaccurate attenuation correction of single photon emission tomography (spect/ct) will affect the image quality of mibg spect and lead to poor diagnosis of small lesions. in addition, 123i-mibg imaging is usually performed at 24 h after injection, while 131i-mibg is performed at 48 h or even 72 h after injection. the procedure is complicated and takes a long time, which limits clinical application. 18f-labeled mfbg is an ideal tracer to show the expression of net. preliminary data show that 18f-mfbg imaging is safe and has favorable biodistribution and kinetics with good targeting of lesions. patients can undergo pet 0.5 hours after injection without special preparation. our study will assess the safety profile, image quality and evaluate the diagnostic performance and tumor burden of 18f-mfbg on nural crest tumors including ppgl and nb. patients with histologically confirmed or clinically suspected neural crest tumor will be prospectively recruited in this study.

Eligibility criteria:
inclusion criteria: - the subject has read, signed, and dated an informed consent form (icf) prior to any study procedures being performed. patients with histologically confirmed or clinically suspicious neural crest tumor. for patients with neuroblastoma, subject should have a routine clinical 123i-mibg scintigraphy (planar + spect/ct) performed within 6 months prior to the inclusion visit or scheduled within 3 months after the inclusion visit. the subject is male or is a nonpregnant, nonlactating female who is either surgically sterile or is post-menopausal. the subject is able and willing to comply with all study procedures as described in the protocol. exclusion criteria: - patients are potentially pregnant (serum and urinary hcg test will be performed in women where pregnancy is not excluded) or is breast-feeding. patients undergo surgery between the selection and inclusion visit. patients who are pregnant, may possibly be pregnant, or wish (including their partners) to become pregnant during the study period, or are lactating. patients who are not suitable to participate in the trial according to researchers.
scleral lens fitting using wide-field oct

Conditions: Keratoconus; Irregular; Contour of Cornea

Summary: the purpose of this study is to see if oct technology can optimize scleral contact lens fittings. subjects with keratoconus, post-penetrating keratoplasty (pk), post-lasik ectasia, post-radial keratotomy (rk), or a variety of anterior surface disorders requiring scleral lens fittings will be considered for enrollment. for each study eye, a clinically-selected scleral lens fit will be compared against an oct-selected lens fit. the quality of each lens fit will be determined by flourescein exam at the slit lamp. apical clearance, limbal clearance, conjunctival compression, and lens edge lift will be assessed. a lens that satisfies all four criteria will be considered satisfactory.


Eligibility criteria:
inclusion criteria: * eyes requiring fit for scleral lenses for kcn, post-pk, post-rk, post-lasik ectasia, or various anterior surface disorders exclusion criteria: * inability to maintain stable fixation for oct imaging * inability to commit to required visits to complete the study * eyes with concurrent retinal diseases, glaucoma, or other eye conditions that may limit visual outcome

Keywords: keratoconus (kcn) irregular cornea optical coherence tomography (oct)
phase iib dose ranging study in subjects with moderate to severe rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the primary purpose of this study is to identify an appropriate dose of study medication.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * diagnosis of active rheumatoid arthritis (ra) by standard criteria (american rheumatism association (ara) \[1987\] or american college of rheumatology/european league against rheumatism (acr/eular) \[2010\]) at least 16 weeks prior to screening * acr global functional status class of 1 to 3 * documented evidence of inadequate response tumor necrosis factor (tnf) inhibitors * all subjects must have been receiving treatment with a minimum dose of 15 mg per week of methotrexate for at least 12 weeks and at a stable dose for 28 days prior to screening. a dose as low as 10 mg methotrexate is permitted if 15 mg could not be reached, due to toxicity. in japan, korea and taiwan, a minimum dose of 7.5 mg per week is permitted. additional treatment with hydroxychloroquine or chloroquine is permitted, if it is at a dose approved for the treatment of ra and the dose has been stable for at least 28 days prior to screening * minimum of 6 swollen and 6 tender joints on a 66/68 joint count at screening and at baseline (day 1) * elevated high-sensitivity (hs) crp and/or esr exclusion criteria: * active serious infection * history of or active tuberculosis (tb) * elevated liver function tests (lfts)
investigation of the role of fhl-1 and myostatin in intensive care unit acquired paresis (icuap)

Conditions: Intensive Care Unit Acquired Paresis; Muscle Wasting

Summary: the primary hypothesis for this study is that myostatin and fhl-1 are important in the development of icuap and that changes in activity levels of muscle will modify the levels of expression and activity of these proteins.

icuap is an increasingly recognised clinical problem associated with significant morbidity and mortality. however the pathogenesis of the diseae is poorly understood and as yet no treatment exists. we believe that both myostatin and fhl-1 will be important in the development of this disease. this is based recent research and that both these proteins are likely to be regulated by sepsis and immobility (two major risk factors for icuap. there is evidence from invitro work that the two are likely to interact. we have designed an interventional trial to investigate the above hypothesis. patients admitted to icu and at risk of developing muscle wasting will be selected and receive electrical muscle stimulation of the quadriceps muscle for 1 week. physiological measurements of peripheral and respiratory muscle strength and quadriceps size will be made pre and post intervention. and muscle biopsies, blood and urine collected from both legs pre and post intervention. the relevant molecular pathways can then be examined.

Eligibility criteria:
inclusion criteria: * high risk patients admitted to aicu. exclusion criteria: * pre existing neuromuscular disease.

Keywords: icuap critical illness muscle wasting icu
bortezomib-based gvhd prophylaxis after allogeneic transplant for patients without matched related donors

Conditions: Leukemia; Lymphoma; Myelodysplastic Syndrome

Summary: a common problem after stem cell transplant is graft-versus-host-disease (gvhd). gvhd is a complication of transplantation where the donor graft attacks and damages some of your tissues. after stem cell transplant, all patients receive prophylactic medications against gvhd. in this research study, we are studying the safety and effectiveness of a bortezomib based gvhd prophylaxic drug combination in participants after myeloablative allogeneic stem call transplantation from a matched unrelated donor, mismatched related or unrelated donor.

before your transplant you will receive conditioning therapy with fludarabine and busulfan given 7, 6, 5, and 4 days before your transplant. on day 0, you will receive selected blood cells taken from your sibling or unrelated donor. you will receive 3 drugs for your gvhd prophylaxis: tacrolimus will be started 3 days before your transplant. it will be given intravenously and later by mouth. you will continue to take tacrolimus for 3 to 6 months after transplant. methotrexate will be given intravenously 1, 3, 6 and 11 days after your transplant. bortezomib will be given intravenously 1, 4, and 7 days after your transplant. on days 1, 4, 7, 30 and 3, 6 and 12 months after your transplant you will have a physical exam, blood work, and be asked to complete a questionnaire.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed advanced and/or aggressive hematologic malignancy (including myelodysplastic syndrome) that is unlikely to be cured by alternative therapies * hla-matched unrelated donor; or 1-locus hla-mismatched related or unrelated donor * ecog performance status 0-2 * adequate organ function * able to understand and willing to sign a written informed consent document * agrees to practice adequate contraception per study requirements exclusion criteria: * pregnant or breastfeeding * recipient of prior allogeneic or autologous stem cell transplantation * prior abdominal radiation therapy * hiv-positive on combination antiretroviral therapy * seropositive for hepatitis b or c * allergies to bortezomib, boron, or mannitol * myocardial infarction within last 6 months, nyha class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias * uncontrolled bacterial, viral or fungal infections * seizures or history of seizures * history of another non-hematologic malignancy unless disease-free for at least 5 years * uncontrolled intercurrent illness

Keywords: stem cell transplant allogeneic transplant donors
effect of platelet-rich factor on implant stability and bone resorption in the lower posterior mandible

Conditions: Osseointegrated Dental Implantation

Summary: the main objective of this clinical trial study is to consider the effect of platelet-rich-factor (prf) on implant stability and marginal bone resorption around dental implants.

dental implants were placed in 30 subjects who have 1 or 2 missing teeth in both side of posterior mandible. implants with a length of 11.5 and a diameter of 4.5 mm will be inserted in both sides. in one side prf will be instilled after surface treatment with prf before implant placement, while no prf was added in other side to serve as control group. all implants will be followed with stability measurement by means of resonance frequency analysis at baseline, and every two weeks up to 3 months. bone height was measured on medial \& distal side on standardized iopa x-rays.

Eligibility criteria:
inclusion criteria: * patients who have 1 or 2 missing teeth in both side of posterior mandible * adequate bone quantity and quality at the implant site * the implant sites with at least 3 months of healing after extraction, * patients well motivated for implant therapy and maintaining good oral hygiene * the implant sites with width and length to installation of an implant of 4.5 mm x 11.5 mm. * patients who gave written informed consent exclusion criteria: * • medically compromised or patients taking any immunosuppressive drugs which may complicate the treatment outcome * infection around the implant site * history of bruxism/parafunctional habits * patients with history of any bleeding disorder or on anti-coagulant therapy. * pregnant patients