Kornimate/medical-research-clean huggingface dataset:
use of autologous bone marrow aspirate concentrate in painful knee osteoarthritis

Conditions: Bilateral Primary Osteoarthritis of Knee

Summary: the overall goal of this study is to develop regenerative cell therapy for use in patients with osteoarthritis (oa). the primary objective of this proposal is to conduct a pilot study that assesses the safety and feasibility of using concentrated bone marrow aspirate containing msc to treat patients with painful knee oa.

patients with symptomatic mild to moderate bilateral knee osteoarthritis will be candidates for this pilot study. baseline data includes radiographs, mri imaging, clinical data on knee pain and analysis of synovial fluid inflammatory markers. bone marrow will be aspirated from the patient's iliac crests and the cellular rich portion will be concentrated. randomly, one knee will be injected with the bone marrow concentrate. the contralateral knee will be injected with only sterile saline for placebo. follow-up analysis of synovial fluid will be at one week and 6 months after injection; clinical data will be obtained at 3, 6 and 12 months and mri imaging will be performed at 6 months after injection, with repeat radiographs at 12 months

Eligibility criteria:
inclusion criteria: 1. male and female subjects are both eligible 2. subjects must be 18 years of age or older 3. subjects must have bilateral oa and pain in both knees. 4. osteoarthritis may be primary or secondary. knees must have kellgren-lawrence grades 1-3. 5. subjects must have previously tried 6 weeks of one of the following conservative treatments activity modification, weight loss; physical therapy, anti-inflammatory or injection therapy 6. patients can provide written informed consent after the nature of the study is fully explained exclusion criteria: 1. patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory results. 2. patients taking anti-inflammatory medications (prescription or over-the-counter), including herbal therapies, within 14 days of baseline visit. 3. patients taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within the 3 months prior to study entry. 4. patients receiving injections to the treated knee within 2 months prior to study entry. 5. patients who are pregnant or currently breast-feeding children. 6. patients with systemic, rheumatic or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, charcot's knee joint, villonodular synovitis, and synovial chondromatosis. 7. patients with ongoing infectious disease, including hiv and hepatitis 8. patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or diabetes 9. patients participating in a study of an experimental drug or medical device within 30 days of study entry.

Keywords: osteoarthritis
study of azacytidine combined with lenalidomide as maintenance therapy based on mrd monitoring in aml

Conditions: Acute Myeloid Leukemia in Remission

Summary: great progress has been witnessed on the treatment of acute myeloid leukemia (aml) in recent years. however, elderly patients ineligible for receiving high dose chemotherapy and allo-hsct, have high relapse rate and treatment-related complications. azacitidine (aza), a listed hypomethylating agent in china in 2018, is the only approved demethylating drug in the treatment of aml, following the nccn guidelines. in addition, lenalidomide(len) has been shown to rapidly enhance cytotoxic t- and natural killer (nk)-cell function and reduce relapse post-chemotherapy in patients with mm, also has substantial activity as a single agent in elderly patients with aml. measurable residual disease (mrd) has been proven to be highly prognostic in quite a number clinical studies. this study is aimed to validate the efficacy and safety advantages of the maintenance therapy that contain aza and len in elderly or unfit for intensive therapy patients with aml based on mrd monitoring.

in this study, elderly or unfit for intensive therapy aml patients who had achieved complete remission(cr) after remission-induction and consolidation chemotherapy were assigned to 3 arms: (1) maintenance therapy with aza combined with len（aza+len）: aza 50mg/m² per day for days 1-5 and len 10mg per day orally for days 6-26 , every 28 days for up to 12 cycles or progression; (2) maintenance therapy with aza only: aza 50mg/m² per day for days 1-5, every 28 days for up to 12 cycles or progression; (3) observation or with supporting therapy. mrd will be assessed by flow cytometry and molecular techniques. the efficacy and safety of the 3 arms will be evaluated in this study.

Eligibility criteria:
inclusion criteria: * diagnosed with acute myeloid leukemia.meet the criteria of the 2016 who classification system(apl were excluded), based on morphology, immunology, cytogenetics and molecular biology (micm) diagnosis. * complete remission was evaluated according to 2020 nccn guidelines after induction treatment. * patients with age≥ 60 years; or age\<60 years unfit for intensive chemotherapy. * volunteered to sign the informed consent. exclusion criteria: * mental disorders or other conditions that cannot meet the requirements of research, treatment and monitoring. * allergic to azacytidine, lenalidomide , or other drugs of this study * age over 80 years. * any other conditions considered by the study investigators that are not suitable for participating in this clinical trial.

Keywords: acute myeloid leukemia azacitidine lenalidomide maintenance therapy mrd
relationships between glp-2 and markers of bone turnover following feeding

Conditions: Obesity

Summary: this study has been designed to study differences bone turnover in relation to glucagon-like peptide-2 (glp-2) following feeding in lean and obese premenopausal women. given the preliminary evidence that glp-2 may act directly on osteoclasts, the investigators plan to determine whether glp2 receptors are expressed in osteoclasts and the effect of glp-2 on bone resorption. hypotheses: 1. acute responses of glp-2 and bone resorption markers following feeding are affected by body fat mass. 2. serum levels of glp-2 are lower in obese pre-menopausal women and are associated with a reduction in trabecular and/or cortical bone mass 3. glp-2 has direct actions on osteoclast resorption via a functional receptor

study objectives: 1. to determine if differences in baseline serum levels of glp-2 are related to differences in bone microarchitecture, structure and strength at the distal tibia and distal radius between obese and lean premenopausal females. 2. to determine whether obesity in premenopausal females influences levels of circulating glp-2 following a standardised glucose meal with a resultant change in markers of bone formation and resorption 3. to test whether glp-2 directly affects osteoclast function via an identifiable receptor

Eligibility criteria:
inclusion criteria: * age 25-40 * caucasian * premenopausal * able and willing to consent * bmi either 18.5-24.9 kg/m2 or ≥30 kg/m2 * completion 'the effects of obesity on bone structure and strength' study rec ref 10/h1308/61 * consented to be approached for future research studies exclusion criteria: * fracture less than twelve months prior to recruitment * history of any long term immobilization (duration greater than three months) * current pregnancy or trying to conceive pregnancy or breast feeding less than one year prior to recruitment * diabetes mellitus * history of or current conditions known to affect bone metabolism, which may include: * diagnosed skeletal disease or osteoarthritis * chronic renal disease * acute or chronic hepatic disease * hyperparathyroidism or hyperthyroidism * malabsorption syndromes * diagnosed endocrine disorders * diagnosed diabetes mellitus * clinically significant hypocalcemia or hypercalcemia * diagnosed restrictive eating disorder * current or clinically significant previous use of medications or treatment known to affect bone metabolism, for example: * depot medroxyprogesterone or the combined oral contraceptive pill * glucocorticoid therapy * anti-convulsant therapy * bone treatments (e.g. bisphosphonates) * alcohol intake of greater than 21 units per week * athlete, defined as an individual participating in competitive sport at amateur or professional level * monogenic and obesity syndromes * history of cancer within the past 5 years excluding skin cancer non melanomas

Keywords: glp2 obesity premenopausal bone formation resorption
laparoscopic/robotic-assisted hysteropexy versus vaginal hysterectomy for the treatment of uterovaginal prolapse

Conditions: Uterovaginal Prolapse; Hysteropexy

Summary: * objective: aimed to compare laparoscopic/robot-assisted hysteropexy with vaginal hysterectomy for uterine prolapse * prospective randomized clinical trial * patient 1. 60yrs or more women and 2. pop-q stage ii with symptom or pop-q iii, iv regardless of symptom * number of patient: 146 * randomize: laparoscopic/robot-assisted hysteropexy vs. hysterectomy * follow up: postoperative 1 year * primary endpoint: recurrence rate 1. recurrence of uterovaginal prolapse pop-q stage ii-iv 2. recurrence of associated symptom * secondary endpoint 1. postoperative 1 year qol, degree of satisfaction evaluation 2. operative time, estimated blood loss 3. hospitalization period, postoperative pain, return to normal activity


Eligibility criteria:
inclusion criteria: * pop-q stage ii with symptom or pop-q iii, iv regardless of symptom exclusion criteria: * abnormal uterine bleeding * significantly enlarged fibroid uterus * postmenopausal uterine bleeding * endometrial pathology * on tamexifen * concomitant medical problems precluding general anesthesia or surgery * damaged agreement ability
study of dacomitinib and osimertinib for patients with advanced egfr mutant lung cancer

Conditions: Metastatic Non-small Cell Lung Cancer

Summary: the purpose of this study is to test the safety of dacomitinib and osimertinib, at increasing doses, to find out what effects, if any, this combination of drugs has on people with metastatic egfr mutant lung cancer that has not been treated with an egfr tki.


Eligibility criteria:
inclusion criteria: * written informed consent * advanced biopsy-proven metastatic non-small cell lung cancer * somatic activating mutation in egfr in a tumor biopsy * no prior egfr inhibitor treatment (gefitinib, afatinib, erlotinib, dacomitinib, osimertinib) however, prior treatment with other chemotherapies are allowed * archival tissue available from a pre-treatment tumor biopsy or willing to undergo a tumor biopsy prior to study initiation. * measurable (recist 1.1) indicator lesion not previously irradiated * karnofsky performance status (kps) ≥ 70% * age \>18 years old * ability to swallow oral medication * agree to use effective methods of contraception from the time of screening until 3 months after treatment discontinuation (for males and females of child-bearing potential) * adequate organ function * ast, alt ≤ 3 x uln * total bilirubin ≤1.5x uln * creatinine ≤ 1.5x uln or calculated creatinine clearance ≥ 60ml/min * absolute neutrophil count (anc) ≥ 1000 cells/mm\^3 * hemoglobin≥9.0 g/dl * platelets ≥100,000/mm\^3 exclusion criteria: * pregnant or lactating women * any radiotherapy within 1 week of starting treatment on protocol. * any major surgery within 1 weeks of starting treatment on protocol. * any evidence of active clinically significant interstitial lung disease * a mean qtc \>470ms (fridericia"s correction), clinically important arrhythmia, conduction or morphology of resting ecg (eg complete lbbb, 1st -3rd degree heart block, any factors that increase the risk of qtc prolongation or risk of arrhythmia) * cardiovascular disease or cerebrovascular disease, cva or mi \ grade ii chf, or serious cardiac arrhythmia uncontrolled by medication or with the potential to interfere with protocol treatment * history of pneumonitis or interstitial lung disease (ild), drug induced ild, radiation pneumonitits that required steroid treatment, and any evidence of clinically active ild * serious chronic gi conditions associated with diarrhea * symptomatic, unstable brain metastases requiring escalating doses of steroids * continue to have unresolved \> ctcae grade 1 toxicity from any previous treatment

Keywords: dacomitinib osimertinib egfr mutant lung cancers 18-411
effectiveness of discontinuing bisphosphonates study: r21 pilot study

Conditions: Osteoporosis

Summary: this is a pilot study evaluating the recruitment strategies for sites and patients, data collection instruments, follow-up procedures, administrative processes, and the proposed management strategy for the future large scale national trial.


Eligibility criteria:
inclusion criteria: 1.females 65+ 2.3+ years of alendronate (fosamax/binosto) use 3. valid social security number exclusion criteria: 1. history of any other metabolic bone condition, such as paget disease of bone 2. currently receiving treatment for ongoing cancer, excluding non-melanoma skin cancer. 3. has significant underlying illness that would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 3 years)? 4. hiv positive 5. involved in a conflicting (investigational drug) clinical trial
a safety and feasibility trial protocol of metformin in infants after perinatal brain injury

Conditions: Hypoxic-Ischemic Encephalopathy; HIE; Neurodevelopment; Infant Development

Summary: infants with hypoxic-ischemic encephalopathy (hie) are at high risk for neurodevelopmental impairment, despite current standards of care. adjunctive treatments to promote brain repair are needed. the antidiabetic drug metformin has recently been recognized as a neurorestorative agent, but, to date, has not been used in infants. herein, the investigator describes a clinical trial with the aim of demonstrating the safety and feasibility of metformin use to improve neurodevelopmental outcomes in infants with hie.


Eligibility criteria:
inclusion criteria: * \<6 months old at time of enrollment, and able to initiate study drug between 3 and 6 months old. * born \> 35 weeks gestational age with a clinical diagnosis of hie at birth, who receive therapeutic hypothermia. * post-hypothermia brain mri with evidence of hypoxic-ischemic brain injury, based on the neuroradiology clinical report. specifically, participants must have had evidence of a lactate peak by magnetic resonance spectroscopy and/or signal abnormalities by conventional (t1 and/or t2) or diffusion-weighted images consistent with hypoxic-ischemic pattern of injury. * english- or spanish-speaking families, as the parents/guardians will be responsible for documenting dose administrations and adverse events. exclusion criteria: * known genetic or chromosomal disorder, and in the presence of congenital or acquired liver or kidney disease that might, in the opinion of the principal investigator (pi) or delegate, affect drug metabolism. * maternal use of metformin while actively breastfeeding. * infant weight below the 10th percentile based on who growth charts at the time of study drug initiation. * normal post-hypothermia brain mri, without evidence of ischemic brain injury, based on the neuroradiology clinical report. * concomitant use of the following drugs: anti-diabetic drugs (insulin, sulfonylureas), steroids, diuretics (furosemide, chlorothiazide, spironolactone), diazoxide, beta blockers, ace inhibitors, angiotensin ii blockers, calcium channel blockers (including nifedipine), phenytoin, valproic acid, topiramate, cimetidine, corticosteroids, thyroid medications, sympathomimetics, carbonic anhydrase inhibitors, or any antibiotics. * any condition or diagnosis, that could in the opinion of the pi or delegate, interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk.

Keywords: hie metformin hypoxic-ischemic encephalopathy pharmacokinetic modeling neonates brain injury
clinical evaluation and patient satisfaction of shade matching between natural teeth and monolithic all-ceramic crowns fabricated from two materials

Conditions: Natural Optical Properties

Summary: evaluation of color difference between zirconia reinforced lithium silicate (celtra press) vs lithium disilicate (emax) in relation to natural tooth structure to determine which monolithic material will provide restoration with exact shade and optical properties as natural tooth structure.

eligible patients will be randomized in 2 equal group between study group (celtra press) and control group (emax) . single tooth in esthetic zone requiring full coverage crown is prepared to receive an all ceramic crown of . grouping: the crowns will be divided into two groups: i:teeth receiving crowns fabricated from ips emax press ( ivoclarvivadent) ii:teeth receiving crowns fabricatedfrom celtrapress(dentsplysirona). shade will be measured using intraoral spectrophotometer and evaluated. the color difference (δe ) will be calculated for each sample using the following equation: δe =\[(δl\*)²+(δa\*)² + (δb\*)²\]½ δe (perceptibility threshold ) will be evaluated for each group.

Eligibility criteria:
inclusion criteria: * 1. age range of the patients from 20-45 years old; able to read and sign the informed consent document, illiterate patient will be avoided. 2. patients able physically and psychologically to tolerate conventional restorative procedures. 3. patients with no active periodontal or pulpal diseases, having teeth with good restorations. 4. patients with teeth problems indicated for full coverage restoration ( coronal fracture where partial coverage would lack retention, malposed or malformed teeth). 5. patients with root canal treated teeth requiring full coverage restorations with contralatral tooth not filled orfractured. 6. patients willing to return for follow-up examinations and evaluation. exclusion criteria: 1. patients in the growth stage with partially erupted teeth. 2. patients with poor oral hygiene and motivation. 3. pregnant women's to avoid any complication that may occur in dental office due to pregnancy or due to injected anesthetic solution. 4. patients with psychiatric problems or unrealistic expectation 5. patients have no opposite occluding dentition in the area intended for restoration\\ 6. patients suffer from parafunctional habits. 7. deep discoloration of abutment . 8. smokers and heavy caffeine consumers. -
pcos (polycystic ovarian syndrome) patients

Conditions: Health Related

Summary: the prospective cohort study for pcos patients was set up to investigate the short- and long-term health consequences in reproductive medical center, first affiliated hospital of zhengzhou university, china.

polycystic ovary syndrome (pcos) affects 8-13% of women. it is a multifaceted condition characterized by chronic anovulation and excess ovarian activity. since last decade, clinical reproductive medicine management system/electronic medical record cohort database (ccrm/emrcd) has been used in reproductive medical center, first affiliated hospital of zhengzhou university, and henan province key laboratory for reproduction and genetics. information of patients (poi, pcos, endometriosis, azoospermia, ect) were recorded comprehensively. the current project plans to recruit pcos participants in our center. biological samples, questionnaires and short/long term health data will be collected. the study is aimed to provide evidence for pcos prognosis.

Eligibility criteria:
inclusion criteria: * pcos patients diagnosed with the rotterdam diagnostic criteria. exclusion criteria: -
evaluation of the safety of reoperation for ipsilateral recurrent tumors after nephron-sparing partial nephrectomy

Conditions: Renal Cell Carcinoma; Robotic Surgical Procedures

Summary: to evaluate the safety of reoperation in patients with renal tumors who have ipsilateral tumor recurrence after nephron-sparing partial nephrectomy.


Eligibility criteria:
inclusion criteria: 1. ipsilateral local rrcc (any recurrence in the ipsilateral kidney and retroperitoneum) exclusion criteria: 1. with distant metastasis; 2. lacking essential sugery information.
surveillance of association of immune status and prognosis of cns germ cell tumor survivors

Conditions: Intracranial Germ Cell Tumor; Intracranial Germ Cell CNS Tumor, Childhood; Surgery

Summary: platinum-based chemotherapy, alternating at 21-days intervals with cycles of ifosfamide, cisplatin, and etoposide (ice) and subsequently received radiotherapy were considered as standard treatment for intracranial germ cell tumors. however, whether reliable clinical data can quantify the damage degree of immunologic function caused by chemotherapy and radiotherapy is still unknown. this project regards the level of lymphocyte and immunocyte in peripheral blood as a quantitative index to reflect the dynamic change of the immunologic function of patients with cns germ cell tumors before and after chemoradiotherapy treatment. meanwhile, the investigators will also investigate the relationship between the level of lymphocyte and immunocyte in peripheral blood and the response rate of therapy.this study is designed to prospectively analyze the dynamic changes of immune status, prognosis and society function after standard treatment in patients with intracranial germ cell tumor.

immune status influences the reaction of anti-tumor and health condition of intracranial germ cell tumor patients. peripheral blood and cerebrospinal fluid lymphocytes subsets, cytokines reflects those and be measured. therefore, we designed the study to estimate patients health condition and survival outcomes in order to provides diversified assessment methods. peripheral blood will be collected from patients who will undergo surgery and/or neoadjuvant or adjuvant chemoradiotherapy. the setting time is before chemoradiotherapy, finishing chemoradiotherapy, pre-operation, postoperative day 1, day 3, day 5, and day 7. these blood samples will be used for detection and analysis in lymphocyte and immunocyte by flow cytometry.

Eligibility criteria:
inclusion criteria: * primary diagnosis of an intracranial germ cell tumor (histologically confirmed intracranial non-germinomatous or germinoma germ cell tumor). * histologically unconfirmed pineal and/or suprasellar tumors with serum/csf beta hcg levels greater than 50 miu/ml or afp levels greater than 10 ng/ml or above institutional norm. * no history of anti-tumor treatment * female subjects of childbearing potential have a negative pregnancy test and must agree to take effective contraceptive measures during the study period and within 3 months after the last dose; * be willing and able to provide written informed consent/assent for the trial exclusion criteria: * patients with immune function deficiency : immunosuppression status, including autoimmune disease, post-operation of organ transplantation, in-taking immunosuppressive drug, human immunodeficiency virus (hiv) positive patients, * known history of active tuberculosis not adequately treated or positive quantiferon tb gold test. * hypoproteinemia (eg, in case of severe liver disease or nephrotic syndrome) with serum albumin \<3.0 g/dl.