Kornimate/medical-research-clean huggingface dataset:
prospective clinical study to evaluate the safety and efficacy of intraarticular administration of micro-grafts of adipose tissue (adipo-micro-grafts) in the treatment of osteoarthritis of the trapezium-metacarpal joint (adipo_micro_grafts_1)

Conditions: Osteoarthritis; Osteoarthritis Thumbs

Summary: the objective of this interventional study is the change in the michigan hand questionnaire (mhq) score over time in subjects with eaton littler grade ii and iii trapeziometacarpal osteoarthritis. the main questions to be answered are: * primary outcomes: differences in the change in the mhq scale measured as a reduction in the score result of 12 points within 6 months from preoperative. * secondary outcomes: change from baseline in hand function measured by grip strength (gripstrength); change from baseline in hand function by lateral grip strength (tippinch and tripodpinch); change in the visual analogue scale (vas) pain scale before the procedure then after the procedure, at 1, 3 and 6 months; safety and tolerance of the treatments.


Eligibility criteria:
inclusion criteria: 1. signed written informed consent. 2. male or female aged ≥ 40 and ≤ 75 years 3. normal axial alignment 4. eaton/littler stage 2-3 5. mhq pain scale 6. willingness to participate in all scheduled follow-ups 7. willingness to abstain from taking level 2 analgesics and opioids for the duration of the study. nsaids and paracetamol are permitted. exclusion criteria: 1. pregnant and/or breastfeeding women. 2. if a woman, of childbearing age and the subject is not using a highly effective method of birth control and is not willing to use it during participation in the clinical trial. highly effective methods of birth control include: combined hormonal contraception (containing estrogen and progestin) combined with ovulation inhibition (oral, intravaginal, transdermal); progestin-only hormonal contraception combined with ovulation inhibition (oral, injectable, implantable); intrauterine device (iud); intrauterine hormone-releasing system (ius); bilateral tubal occlusion; vasectomized partner; sexual abstinence; 3. intra-articular injection within 3 months of treatment. 4. immunocompromised for reasons such as corticosteroid therapy, chemotherapy, antiangiogenic or immunosuppressive agents, or due to immunodeficiency syndromes 5. previous hand surgery within the last 6 months 6. history of connective tissue disease, such as systemic lupus erythematosus, systemic sclerosis, sjögren's syndrome or mixed connective tissue disease 7. infections in the trapezium-metacarpal joint, skin disease or infections in the area of the injection site

Keywords: adipose stem cells rigenera protocol trapeziometacarpal arthritis microfragmented adipose tissue
romiplostim n01 for platelet recovery in adult hematologic malignancies patients undergoing ucbt

Conditions: Platelet Recovery After Umbilical Cord Blood Transplantation

Summary: to evaluate the efficacy and safety of romiplostim n01 for platelet recovery after umbilical cord blood transplantation (ucbt) in patients with hematological malignancies.

allogeneic hematopoietic stem cell transplantation (allo-hsct) is an important means of curing a wide range of hematologic diseases, and good hematopoietic and immune reconstitution after transplantation is one of the most important factors determining the success of the transplantation.persistent thrombocytopenia after allo-hsct is one of the common post-transplantation complications.this is an investigator-initiated, single-center, single-arm, phase ii clinical trial to evaluate the efficacy and safety of romiplostim n01 for platelet recovery after ucbt in patients with hematologic tumors. the study was conducted in patients ≥18 years of age with a diagnosis of hematological neoplasia who underwent ucbt. subjects will be screened and receive roprostin n01 from +1 to +28 days after ucbt after signing an informed consent form, and the study will focus on the cumulative plt implantation rate at 28 days after transplantation as the primary efficacy measure. the study is planned to enroll 34 patients.

Eligibility criteria:
inclusion criteria: * age ≥12 years old, male or female; * patients diagnosed with hematological malignancies and undergoing ucbt; * ecog score ≤2; * voluntary participation in this clinical trial, patients fully understand the trial content and sign the informed consent exclusion criteria: * pregnant or lactating women； * known allergy to romiplostim n01; * a history of severe thrombotic events or known risk factors for thrombosis or active thromboembolism requiring anticoagulation; * a history of platelet dysfunction or bleeding prone disease or severe bleeding (requiring more than 2 units of red blood cell infusion or a hematocrit drop of ≥10%) within 7 days prior to screening; * chronic active hepatitis b and c; * repeat or multiple transplantation or multiple organ transplantation; * hiv positive, ebv-dna positive, cmv-dna positive; * have severe infection or complicated with serious heart, liver, lung, kidney, neurological or metabolic diseases; * a serious adverse event (level 4 or 5) as defined by the standard general terminology for adverse events version 4.0 occurred during the pre-treatment period; * participants participate in another clinical study with any exploratory drug or device within 30 days prior to baseline visit; observational studies are allowed; * subjects with cognitive impairment or uncontrolled mental illness; * subjects and/or authorized family members to refuse treatment with romiplostim n01; * those who are judged by the researchers as not suitable for inclusion (such as accompanying medical history, which may affect the safety of the subjects or it is estimated that the treatment cannot be adhered to due to financial problems).
rosuvastatin affecting aortic valve endothelium

Conditions: Atherosclerosis; Hypercholesterolemia

Summary: recent studies support the hypothesis that aortic stenosis (as) develops due to atherosclerosis affecting the aortic valve endothelium. the study's aim was to assess rosuvastatin on the hemodynamic progression and inflammatory markers of as by treating low-density lipoprotein (ldl) in patients with as according to the national cholesterol education program adult treatment panel iii (ncep-atpiii) guidelines for one year.

background: recent retrospective studies support the hypothesis that statins slow the progression of aortic stenosis. the aim of this study was to assess the effect of rosuvastatin on hemodynamic progression of aortic stenosis by treating patients with aortic stenosis and elevated ldl-cholesterol for 18 months. methods: we performed an open-label, prospective study evaluating 121 consecutive patients with asymptomatic moderate to severe aortic stenosis (ava≥ 1.0 cm2), (mean age 73.7±8.9 years; 57 men and 64 women), treated with and without rosuvastatin according to the ncep-atpiii guidelines. echocardiographic, serum lipid, and inflammatory markers were measured at baseline and every 6 months for 18 months.

Eligibility criteria:
inclusion criteria: * asymptomatic as * normal ejection fraction * elevated ldl \>130 mg/dl exclusion criteria: * echocardiographic evidence of rheumatic mitral valve disease, * previous statin therapy, * congenital heart disease (bicuspid aortic valve), * subaortic obstruction, * creatinine ≥ 2,0 mg/dl (to avoid the potential confounder of an elevated serum \[cap04\]), * evidence of liver disease, * greater than mild aortic regurgitation and previous aortic valve surgery

Keywords: aortic stenosis statins hypercholesterolemia
does low flow anesthesia reduce postanaesthetic emergence agitation?

Conditions: Agitated; State, Acute Reaction to Stress

Summary: in this study, the investigators aimed to compare postanesthetic agitation in patients undergoing laparotomic gynecological surgery under general anesthesia using sevoflurane at a fresh gas flow rate of 2 l / min with fresh gas flow rate of 0.5 l / min.

emergence agitation is a temporary state of mental anxiety that occurs during general anesthesia recovery. it is characterized by emergence agitation, hallucination, excitation, delusion and confusion. increased hemorrhage due to hypertension may cause serious complications such as injury to the surgical site, patients' self-removal of surgical drains and catheters, and self-extubation. due to these, emergence agitation results need for additional treatment, psychological stress and increased medical workload for patients and their families. emergence agitation after general anesthesia in adult patients was reported up to 20%. however, the ratios are very wide. in our operating room, the investigators observed that patients with low flow anesthesia were less agitated in the recovery phase than patients with normal flow anesthesia. in our researches, the investigators have not found any studies on the agitation values of patients who underwent low flow anesthesia in the literature.

Eligibility criteria:
inclusion criteria: * asa physical status 1 and 2, underwent gynicological laparotomic surgery under general anesthesia, followed up in pacu(postoperative care unit) exclusion criteria: * asa 3 or 4, mental retardation, psychiatric disease, history of malignant hyperthermia in patient or her family, neurological disease, morbid obesity, history of asthma and follow-up in the intensive care unit.

Keywords: postanesthesia agitation general anesthesia low-flow anesthesia
optimised post-discharge care in older patients after surgery for colon cancer (eras 3.0)

Conditions: Colon Cancer; Frailty

Summary: the purpose of the study is to investigate whether an extended program (eras 3.0) initiated hospital discharge, can improve recovery in elderly, frail patients who have undergone surgery for colon cancer. the study is a randomised controlled trial with two groups: an intervention group receiving the eras 3.0 program and a control group recieving standard care. the eras 3.0 program includes a comprehensive geriatric health assessment, dietary counseling from a dietitian, and instructions on training and physical activity. these activities will take place in the participant's homes after hospital discharge. data will be collected at multiple time points: at the hospital, 12 days post-discharge (at the outpatient clinic), and at 1 and 3 months post discharge in the participants' homes.


Eligibility criteria:
inclusion criteria: * age 65+ * clinical frailty scale preoperative score 4-7 * nutritional risk screening tool (nrs 2002) \> 3 * elective colonic resection * no stoma planned * minimally invasive surgical approach (laparoscopic or robotic) * patients discharged to own home * informed consent to participate exclusion criteria: * stoma creation during index surgery * conversion to laparotomy * major complications following surgery (clavien-dindo \>3a) * participation in other randomised trials in conflict with the protocol and end- points of the eras 3.0 project * discharged with tube feeding and parenteral nutrition (partially or completely) * known food allergies to dairy or any other ingredient contained in the nutrition package * incapable of providing informed consent * discharge to 24-hour municipal rehabilitation facility * all conditions including psychological, geographical, and social factors that could hinder adherence to the trial protocol * neoadjuvant radio- or chemotherapy

Keywords: eras 3.0 colon cancer surgery comprehensive geriatric assessment
measuring the effect of dupilumab treatment on mucociliary clearance (mcc) in subjects with moderate to severe asthma

Conditions: Asthma

Summary: single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.


Eligibility criteria:
inclusion criteria: * moderate - severe th2 (type 2) high asthma, as defined by forced expiratory volume in one second (fev1) \<90% predicted, on medium to high dose inhaled corticosteroids (ics) with or without a second controller * age \> 18 * inhaled steroid doses of 500micrograms (mcg) per day or more (fluticasone equivalent) * reversibility \>/= 12% at screening or within the past 2 years, or a positive methacholine challenge test within the past 2 years, or a positive methacholine challenge during screening * fev1/forced vital capacity (fvc)\<75% * blood eosinophils (eos) \>300 cells per mm3 * exhaled nitric oxide (feno) \>25 parts per billion (ppb) * asthma control test (act) score \<20 exclusion criteria: * pregnant, nursing, or unwilling to test for pregnancy * current smoker or \>10 pack year smoking history * body mass index (bmi)\>37 * respiratory infection in the last 30 days * use of antibiotics or oral prednisone in the last 30 days * current or previous use of dupilumab * current or recent use of anti-il-5 therapies * any other criteria that place the subject at unnecessary risk * diagnosis of other lung diseases including chronic obstructive pulmonary disease (copd) * history of non-skin cell cancer in the last 5 years * drug or alcohol addiction in the last 5 years * any other uncontrolled disease
greenbladder - early detection of bladder cancer in residents in greenland using a urinary marker and a mobile cystoscopy unit

Conditions: Urinary Bladder Neoplasms

Summary: the goal of this observational study is to evaluate whether a urinary biomarker (xpert® bladder cancer detection test) can be used as a selection tool to decide which patients that should undergo cystoscopy in haematuria work-up or in other indications where bladder tumor is suspected. hereby, the investigators will investigate in which patients where cystoscopy can be omitted, particularly in areas with limited access to urological service. with these more selected investigations, patients with bladder tumors will potentially be selected to earlier diagnosis compared to the current non-selected investigations with the inherent logistic and economical challenges. with this strategy, the investigators aim at improving the current poor prognosis for bladder cancer patients in greenland.

methods: citizens of greenland above the age of 18 years referred for cystoscopy will be invited to participate in an observational study at the time of already planned cystoscopy. hypothesis: the investigators hypothesize that the xpert® bladder cancer detection test can identify patients with a bladder tumor and serve as a future selection tool to support clinical decision whether to perform a cystoscopy or not - especially in areas with limited access to urological services. perspectives: the investigators hope to improve the current poor prognosis for bladder cancer patients in greenland with the early detection. if this is successful, it could change the way patients are examined for bladder cancer in greenland, but in the long term also in denmark and other countries. thus, the study will be able to determine whether a simple urine examination should be introduced early in the current cancer program in order to reduce the number of patients who need to undergo a cystoscopy and who can avoid this and get an earlier clarification.

Eligibility criteria:
inclusion criteria: * ≥18 years of age at the time of signing the informed consent form with an indication for cystoscopy and planned for this already at study inclusion. * ability to understand the participant information sheet orally and in writing in either danish or greenlandic. * signed informed consent form. * is, according to the investigator's judgement, able to comply with the trial protocol. exclusion criteria: * patients not willing to participate.

Keywords: bladder cancer
empagliflozin on cardiac-renal injury in patients with steami patients after primary pci

Conditions: Reperfusion Injury, Myocardial

Summary: this study is a single-center, prospective controlled trial addressing effectiveness of empagliflozin on cardiac-renal injury in patients with stemi. patients were randomized using a computer-generated sequence to either placebo or empagliflozin at a 1:1 ratio. investigators, participants, and other study personnel were blinded to the assigned treatment for the duration of the study. the primary objective of this study is to investigate the effects of empagliflozin on myocardial infarct size measured using cardiac magnetic resonance (cmr) methods at 3 months. key secondary endpoint: incidence of ciaki within 48h after pci. inclusion criteria:patients with stemi who were admitted to the chinese pla general hospital were recruited between ocotor 2018 and january 2019. stemi was defined as typical chest pain lasting \>30 minutes within the previous 12 hours, a clear st-segment elevation of \>0.1 mv in two or more contiguous electrocardiographic leads, and elevated blood levels of troponin t.exclusion criteria:cardiogenic shock ,hypoglycaemia ,diabetic ketoacidosis,genital and urinary infections,history of myocardial infarction,stent thrombosis,previous coronary artery bypass surgery,type 1 diabetes,severe hepatic insufficiency,advanced cancer patients,egfr\<30 ml/min. all patients were informed of the potential risks (genital mycotic infections, urinary tract infections, diabetic ketoacidosis) associated with empagliflozin and then required to submit written informed consent before being included in the study. patients were randomized using a computer-generated sequence to either placebo or empagliflozin at a 1:1 ratio. patients in the empagliflozin group were treated with empagliflozin whereas patients in the control group were given placebo. the treatment started 30 minutes before pci with a dose of 10 mg empagliflozin or placebo administered in the ambulance. after admission, patients were treated with 10 mg empagliflozin once daily for 3 mouths.


Eligibility criteria:
inclusion criteria: * patients with stemi who were admitted to the chinese pla general hospital were recruited between june 2018 and september 2018. exclusion criteria: * cardiogenic shock * hypoglycaemia * diabetic ketoacidosis * genital and urinary infections * history of myocardial infarction * stent thrombosis * previous coronary artery bypass surgery * type 1 diabetes * severe hepatic insufficiency * advanced cancer patients * egfr\<30 ml/min

Keywords: empagliflozin percutaneous coronary intervention reperfusion injury microvascular protection ci-aki no-reflow phenomenon
pd-1 antibody, chidamide, lenalidomide and gemcitabine for peripheral t-cell lymphoma

Conditions: Peripheral T-cell Lymphoma

Summary: to observe the safety, tolerability and clinical effects of pd-1, chidamide, lenalidomide and gemcitabine in the treatment of newly diagnosed and relapse/refractory peripheral t-cell lymphoma.

patients with peripheral t-cell lymphoma usually have a bad prognosis. these patients cannot be treated successfully with the conventional chop regimen. the investigators have been proceeding this trial to evaluate the efficacy and safety of the pd-1, chidamide, lenalidomide and gemcitabine in the treatment of newly diagnosed and relapse/refractory peripheral t-cell lymphoma.

Eligibility criteria:
inclusion criteria: * age:14-65 years;eastern cooperative oncology group (ecog)score≤3;expected survival≥3 months * patients with peripheral t-cell lymphoma diagnosed by immuno-histochemistry (ihc); * acceptable hematological indicators, no chemotherapy contraindications; * total bilirubin ≤ 1.5 times the upper limit of normal (uln), alanine aminotransferase (alt) ≤ 2.5 x upper age limit (uln), if the abnormal laboratory parameters are considered to be caused by lymphoma, patients eligible conditions should be adjusted to be incorporated into the group; * at least one measurable lesion by ct or pet-ct（positron emission tomography-computed tomography）; * exclude other major diseases, normal heart and lung function; * female patients of childbearing age are negative for pregnancy test; * cooperate with follow-up; * there are no other related treatments including traditional chinese medicine, immunotherapy, and biologic therapy (except for the treatment of anti-bone metastases and other symptoms); * signing informed consent \*: pathological histology must be consulted by a pathologist at a provincial hospital. exclusion criteria: * patients with alk-positive anaplastic large cell lymphoma or angioimmunoblastic t-cell lymphoma * rejecting providing blood preparation; * allergic to drug in this study and with metabolic block; * rejecting adopting reliable contraceptive method in pregnancy or lactation period; * uncontrolled internal medicine disease(including uncontrolled diabetes,severe incompetence cardiac, lung, liver and pancreas）； * with severe infection; * with primary or secondary central nervous system tumor invasion; * with immunotherapy or radiotherapy contraindication; * ever suffered with malignant tumor; * having peripheral nervous system disorder or dysphrenia; * with no legal capacity,medical or ethical reasons affecting research proceeding; * participating other clinical trials simultaneously; * adopting other anti-tumor medicine excluding this research; * patients with immunodeficiency, such as primary immunodeficiency syndrome or organ transplant recipients * human immunodeficiency virus (hiv)-positive patients * the researchers considering it inappropriate to participate in the study. * patients with immune system diseases

Keywords: pd-1 chidamide lenalidomide gemcitabine peripheral t-cell lymphoma
a study of rgls8429 in patients with autosomal dominant polycystic kidney disease

Conditions: Autosomal Dominant Polycystic Kidney Disease; ADPKD; Polycystic Kidney, Autosomal Dominant

Summary: primary objectives * to assess the safety and tolerability of rgls8429 * to assess the impact of rgls8429 on adpkd biomarkers secondary objectives * to assess the impact of rgls8429 on height-adjusted total kidney volume (httkv) * to characterize the pharmacokinetic (pk) properties of rgls8429 * to assess the impact of rgls8429 on renal function

this is a randomized, double-blind, placebo-controlled multiple ascending dose and an open-label fixed-dose phase 1b study consisting of two parts, part a and part b. in part a, multiple ascending doses of rgls8429 or placebo will be administered via subcutaneous injection to subjects with adpkd to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of rgls8429. in part b, a fixed-dose of rgls8429 will be administered via subcutaneous injection to subjects with adpkd to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of rgls8429.

Eligibility criteria:
key inclusion criteria: 1. male or female adpkd patients, 18 to 70 years old 2. class 1c, 1d, or 1e mayo imaging classification of adpkd (based upon either the mri obtained during screening, or a prior mri obtained within 5 years of screening with documented mayo classification) 3. egfr between 30 to 90 ml/min/1.73 m2 4. body mass index (bmi) 18 to 35 kg/m2 5. must understand and consent to the study procedures explained in the icf and be willing and able to comply with the protocol key exclusion criteria: 1. administration of tolvaptan in the 28 days before randomization 2. subject is mentally incapacitated or has significant emotional problems 3. any medical condition or social circumstance that, in the opinion of the investigator, may make the subject unlikely to complete the study or comply with study procedures and requirements; or may pose a risk to the subject's safety 4. history or presence of alcoholism or drug abuse within the past 2 years prior to screening 5. only one kidney or kidney transplant recipient 6. participation in another clinical trial and/or exposure to any investigational drug or approved therapy for investigational use within 28 days or 5 half-lives of the investigational drug's dosing, whichever is longer, prior to dosing. the 28-day or 5-half-life windows will be calculated from the date of the last dosing in the previous study to day 1 of the current study.