Kornimate/medical-research-clean huggingface dataset:
multicenter study to assess the efficacy of decitabine in the treatment of chronic myelomonocytic leukemia

Conditions: Chronic Myelomonocytic Leukemia

Summary: the study aims to assess the activity of decitabine in the treatment of cmml.


Eligibility criteria:
inclusion criteria: 1. patients aged 18 and older 2. cmml diagnosis according to who criteria 3. if wbc\<=12000/mm3:ipss high or int-2 if wbc\>12000/mm3: at least two of the following criteria: * blast cells\>5% in the bone marrow * citogenetic abnormality other then t(5;12) (q33;p13) * anemia (hb\<10g/dl) * thrombocytopenia (plt\<100000/mm3) * splenomegaly(\>5cm below costal margin) * extramedullary localization 4. patients untretaed or previously treated with hydroxyurea or imatinib or etoposide given orally or non intensive chemotherapy or intensive chemotherapy given more thann 3 months befor inclusion 5. performance status ecog 0,1 or 2 6. estimated life expectancy\>=6 months 7. adequate hepatic function: * total bilirubin \< 1.5 times upper limit of normal (except moderate unconjugate hyperbilirubinemia due to intra medullary hemolysis) * ast and alt \< 3 times limit of normal 8. adequate renal function: * serum creatinine \< 1.5 times limit of normal * creatinine clearance \> 30ml/min 9. informed consent 10. negative pregnancy test or adequate contraception methods exclusion criteria: 1. myeloproliferative/myelodisplastic syndome othe than cmml 2. acute blastic transformation of cmml with bone marrow blast cells\>20% 3. patients eligible for allogenic bone marrow transplantation with identified donor 4. cmml with t(5;12) o pdgfbr rearrangement 5. intensive chemotherapy given less than 3 months before 6. previous treatment with hypomethylating agent 7. age\< 18 years old 8. pregnancy or breastfeeding 9. performance status ecog\>2 10. estimate life expectancy\<6 months 11. hiv infection 12. chronic active hepatitis secondary to hcv or hbv (hbsaq positive) 13. serious concomitantsystemic disorders, including active bacterial fungal or viral infection, that in the opinion of the investigator, would compromise the safety of the patient and/or his/her ability to complete the study

Keywords: myelodysplastic syndromes, chronic myelomonocytic leukemia, decitabine
protocol design of hand robotics assisted therapy in patients with different severity of stroke

Conditions: Stroke

Summary: some studies have shown that the end-effector type of hand robotic-assisted therapy (rt) can effectively improve upper extremity (ue) motor function in patients with stroke. however, these studies provide insufficient information on treatment protocol, making it difficult for therapists to apply the rt in clinical practice. this study aims to develop an end-effector rt treatment protocol and to examine the preliminary effects of the treatment protocol on ue motor function in patients with stroke.

there are two objectives in this case series study. one is combining external scientific evidence with clinical expertise to design a detailed training protocol for rt in patients with different severity of stroke. the other is to examine the effects on ue motor function and explore the client perspective. the training protocol was developed based on the ace star cycle knowledge transformation model, which includes steps such as summarizing previous evidence and adjusting the protocol after practice by therapists. purposive sampling will be used to recruit 35patients with stroke with different severities (brunnstrom stage of distal part: 10 for stage ii\~iii /10 for stage iv /15 for stage v\~vi) from a regional hospital in taiwan. each participant will receive 12-15 sessions of 50-60 minutes intervention over 3 weeks. motor function evaluations will be administered before and after the intervention. wilcoxon signed rank test will be used to examine the change between the pretest and posttest.

Eligibility criteria:
inclusion criteria: * (1) unilateral stroke patients diagnosed by neurologists with stable life conditions * (2) twenty years old or older * (3) modified ashworth scale of proximal ue ≤ 3 (shoulder and elbow), and modified ashworth scale of distal ue ≤ 2 (wrist and fingers) * (4) ue subscale of fugl-meyer assessment score \< 60 * (5) cognitive test with the mini mental state examination ≥ 21 * (6) can provide informed consent exclusion criteria: * (1) joint contracture greater than 10° in the paretic wrist or hand * (2) absence of proprioception in the wrist and hand * (3) other neurological or psychological disorders, e.g. parkinson's disease * (4) receiving botulinum toxin injections within 3 months * (5) enrolling in other rehabilitation experiments or drug studies within 3 months * (6) unable to operate the amadeo training system or who may have safety concern

Keywords: stroke robotic training neurorehabilitation
tranexamic acid versus placebo for the reduction of blood loss in total hip replacement surgery

Conditions: Hip Replacement, Total

Summary: the bleeding caused by hip replacement surgery (crt) is an important source of demand for blood in the hospital. tranexamic acid (txa) is a drug that has proved useful in reducing bleeding associated with other surgeries and crt results have been positive, but the variety of dosages difficult to evaluate the results to determine the efficacy and safety of txa in reducing bleeding caused by surgery of total hip replacement. patients: patients asa(american society of anesthesiologists) i-iii that they are to perform hip replacement surgery and cementless unilateral total that have signed the informed consent. group a: 1st dose 15mg/kg of txa in 100ml saline 0.9% after the completion of regional anesthesia, and before the start of surgery. 2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration. group b: 1st dose: 10mg/kg of txa in 100ml 0.9% saline after the completion of regional anesthesia, and before the start of surgery. 2nd dose: intravenous infusion over 10 minutes of 10mg/kg of txa in 100ml saline 0.9% at three hours after the first administration. group c: 1st dose: intravenous infusion over 10 minutes in 100ml of 0.9% saline after the completion of regional anesthesia, and before the start of surgery. 2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration. statistical analysis comparison of blood loss in groups and comparison of adverse events


Eligibility criteria:
inclusion criteria: * 18 years or more * asa i-iii * no allergies tranexamic acid * informed consent signed by patient exclusion criteria: * pregnancy or lactation. * severe vascular ischemia (coronary or peripheral) * previous venous thrombosis, pulmonary embolism or embolic disease (atrial fibrillation, active neoplastic disease) * coagulopathy * chronic treatment with asa(acetylsalicylic acid) or nsaids (nonsteroidal anti-inflammatory drugs) prior to surgery without suspension * hemoglobine \<10 * moderate renal impairment (creatinine\> 2) * cirrhosis * contraindication to prophylaxis with enoxaparin * patients with a history of seizures.

Keywords: total hip replacement tranexamic acid
a long-term data collection study of participants in france aged 6 years old or more with atopic dermatitis receiving dupilumab

Conditions: Atopic Dermatitis

Summary: this is a long-term study to collect data over 3 years in order to find out what is likely to happen in the future regarding participants 6 years of age and older who receive dupilumab for atopic dermatitis (ad) commonly known as eczema, and to characterize real-world effectiveness, safety and use patterns of dupilumab in real world setting in france. patients will be invited to participate if initiating treatment with dupilumab for ad according to french-specific prescribing information. the decision of initiation of the treatment is independent to the study's participation. the study will be conducted in approximately 50 centers in france to evaluate a representative sample of patients treated in france. at each participating site, all ad participants who receive an initial prescription for dupilumab will be invited to participate in this study, until the enrollment goal is achieved.


Eligibility criteria:
inclusion criteria: * male or female, 6 years or older. * initiating treatment with dupilumab for ad according to french-specific prescribing information (≥ 12 years old: moderate to severe ad versus 6-11 years old: severe ad). the decision of initiation of the treatment is independent to the study's participation. * able to understand and complete study-related questionnaires. * signed informed consent form. for participants \<18 years old, informed consent form signed by the parent/legal guardian and participant's assent obtained. exclusion criteria: * patients who have a contraindication to the drug according to the french-specific prescribing information label. * any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from adequately completing, as per routine care, the schedule of visits and assessments. * patients currently participating in any interventional clinical trial. * patients previously treated with dupilumab. * patients under tutorship or curatorship; patients under safeguard of justice or deprived of his/her liberty by an administrative or court decision.
comparison of erector spinae plane block and combination of deep and superficial serratus anterior plane block

Conditions: Pain, Postoperative; Thoracic Surgery, Video-Assisted; Erector Spinae Plane Block; Serratus Anterior Plane Block; Multimodal Analgesia

Summary: video-assisted thoracic surgery (vats) has become a common procedure in thoracic surgery. severe postoperative pain may be encountered in patients undergoing vats. analgesic methods such as thoracic paravertebral block (tpvb), intercostal block and erector spina plane block (espb) are widely used for vats. among these methods, ultrasound (us) guided tpvb is the most preferred method. in recent years, the frequency of application of plane blocks as a component of multimodal analgesia has been increased. espb and sapb are some of them. generally, comparisons are made between espb and tpvb in studies and the analgesic effect is evaluated.there are two techniques for sapb application. in deep sapb (dsapb) application, local anesthetic agent is given under the serratus anterior muscle. in the superficial sapb (ssapb) application, the local anesthetic agent is given above the serratus anterior muscle. since it is done by entering from the same point in two applications, it is possible to perform these two applications at the same time with a single needle entry. the mechanisms of regional analgesia techniques used after thoracic surgery operations are also different from each other. therefore, it may be possible to obtain a more effective analgesic effect in patients by combining the mechanism of action of dsapb and ssapb , as in the multimodal analgesia method. this study seeks to evaluate the effect of espb and combined dsapb-ssapb pain after vats.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years * american society of anesthesiologists physical status i-ii-iii * body mass index between 18-30 kg/m2 * patients undergoing elective video assiste thoracoscopic surgery exclusion criteria: * patient refusing the procedure * history of chronic analgesic or opioid therapy * history of local anesthetic allergy * infection in the intervention area * emergency surgery
executive function in learning in children with attention deficit hyperactivity disorder (adhd) receiving medical treatment alone compared to children receiving additional treatment to improve learning strategies

Conditions: ADHD

Summary: the purpose of this study is to determine whether there is a difference in executive function in learning in children with adhd receiving medical treatment alone to the executive function in children receiving, in addition to medical treatment in learning strategies.


Eligibility criteria:
inclusion criteria: * normal development for age * adhd exclusion criteria: * low compliance * developmental delay * chronic disease
french registry of children treated with norditropin® for short stature associated with noonan syndrome

Conditions: Noonan Syndrome

Summary: this is a non-interventional registry of children treated with norditropin® for short stature due to noonan syndrome (ns). this study aims to provide data on long-term growth evolution and safety of norditropin® as well as health related quality of life (hrqol) data. this registry will include the entirety of children treated with norditropin® for short stature due to ns over the inclusion period. the decision to initiate treatment with commercially available norditropin® is made by the patient/parents/legally acceptable representative (lar) and the treating physician before and independently from the decision to include the patient in this study.


Eligibility criteria:
inclusion criteria: * patients with a clinical and/or genetic diagnosis of ns * patients who are treated with norditropin® (already treated or initiating) and who are followed in a participating center * the decision to initiate treatment with commercially available norditropin® has been made by the patient/parents/legally acceptable representative (lar) and the treating physician before and independently from the decision to include the patient in this study exclusion criteria: * patients/parents/lar opposed to the collection and processing of their children's medical data * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
an observational study of mabthera in participants with severe active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this observational study will evaluate the effect on disease activity and the safety in routine clinical practice of mabthera (rituximab) in participants with active seropositive rheumatoid arthritis, who have an inadequate response to one or more tumour necrosis factor inhibitor (anti-tnf) therapies.


Eligibility criteria:
inclusion criteria: * age \>18 years with rheumatoid arthritis (ra) * seropositive participants with ra (positive for rheumatoid factor (rf) and/or anti-citrullinated cyclic peptide \[ccp\]) * active disease despite receiving one or more tnf inhibitors * absence of serious or active infection exclusion criteria: * participants with serious history of heart failure (class new york heart association \[nyha\] iv) or severe uncontrolled heart disease * participants pregnant or lactating * prior treatment with mabthera® * participants receiving any other investigational product in the context of other clinical study * participants with known hypersensitivity to rituximab or to any of the excipients
cardiac resynchronization and arrhythmias sensing via the left bundle.

Conditions: Left Bundle Branch Area Pacing

Summary: evaluation of ventricular arrhythmias sensing via a left bundle branch area pacing lead.


Eligibility criteria:
inclusion criteria: * ischemic or non-ischemic cardiomyopathy * left ventricular ejection fraction ≤35% despite optimal medical therapy * left bundle branch block with qrs ≥130 milliseconds exclusion criteria: * previously implanted intra-cardiac material
the study of the efficacy of laser acupuncture on osteoarthritis knees by using magnetic resonance imaging, clinical evaluation, and movement analysis

Conditions: Osteoarthritis, Knee

Summary: to study the efficacy of laser acupuncture on osteoarthritis (oa) knee patients by magnetic resonance imaging (mri), clinical evaluation and movement analysis.

the kellgren-lawrence (kl) grading scheme for oa knee patient selecting flow age: 20-70 year old grade ii-iii knee oa exlusion: trauma history/ space claustrophobia /severe chronic disease/ malignancy pregnancy study cases 40 randomize pre-treatment mri (to evaluate grade of oa knee/ the t2 signal of the cartilage), mrs (baseline glutamate), movement analysis(sit to stand), maximum strength ratio of quadriceps/hamstring womac post-treatment evaluation laser therapy modality: la-400 treatment protocol of low level laser * 40mw, 50hz, 808nm (invisible light) , 15min * the effect of laser acupuncture is dose dependent effect of laser therapy on chronic osteoarthritis of the knee in older subjectsj lasers med sci. 2016 spring; 7(2): 112-119 * 830nm is an effective form of treatment for chronic knee pain caused by knee osteoarthritis. low level laser therapy for chronic knee joint pain patientslaser ther. 2014 dec 27; 23(4): 273-277 * duration: 2 weeks frequency: 3 times/week * control group: no treatment acupuncture point: ex- le-5, ex-el 2, sp10

Eligibility criteria:
inclusion criteria: * kellgren-lawrence grade ii \~ iii exclusion criteria: * trauma history/ space claustrophobia/ severe chronic disease/malignancy pregnancy
randomized clinical trial of bisacodyl versus placebo on postoperative bowel motility in elective colorectal surgery

Conditions: Postoperative Ileus

Summary: postoperative bowel dysmotility is a frequent condition after colorectal surgery. the influence of colon stimulating laxatives have not been studied. this prospective, randomized, double blind, placebo controlled study assesses the influence of bisacodyl on postoperative bowel motility in patients undergoing elective colorectal surgery. the hypothesis of this trial was that bisacodyl has a beneficial effect on the duration of postoperative ileus.

all adult (\>18 years) patients admitted for elective colorectal resection were evaluated for eligibility. patients were randomized using a computer programme and received either 10mg of bisacodyl in non-transparent capsules or identical placebo capsules, containing glucosemonohydricum. the capsules were administered twice daily, starting one day before surgery and ending on postoperative day three.patients and all involved medical personnel were blinded. bowel preparation was not routinely used in open surgery, whereas in patients undergoing laparoscopic resection two litres of sodium-sulfate / macrogol solution (cololyt®, spirig pharma ag, switzerland) was administered. standard colorectal surgery was performed in all patients. in open surgery a midline incision was used for laparotomy. in laparoscopic resections a four-port technique with removal of the specimen through a small transverse incision in the lower abdomen was used. all patients received perioperative single shot antibiotics, cefuroxime 1.5 g and metronidazole 1g. nasogastric tube (ngt) was scheduled to be removed at the end of surgery. postoperative treatment was not changed during the study. all patients received postoperatively a basic analgesia of 500 to 1000 mg oral paracetamol every 6 h; additionally, metamizol was administrated intravenously or orally as needed. the primary endpoint was the time to recovery of gastrointestinal function, defined as the mean time to the occurrence of the following three events (gi-3): first flatus passed, first defecation and first solid food tolerated. we did not include the presence of bowel movement, as they may be present before recovery of the colon due to small bowel activity24. secondary endpoints were the incidence of ngt reinsertion, duration of ngs reinsertion, incidence of postoperative vomiting and length of hospital stay. additionally, consumption of analgesics and pain, cramping and nausea scores (assessed with a visual analogue scale \[vas\]) during the first 8 postoperative days were monitored. other variables recorded were patients' demographics, use of epidural anaesthesia, type and duration of surgery and morbidity.

Eligibility criteria:
inclusion criteria: * elective colorectal resection * age \>18 years exclusion criteria: * preoperatively planned stoma formation * emergency surgery * pregnancy * known hypersensitivity for bisacodyl

Keywords: postoperative ileus colorectal surgery bisacodyl laxatives
mf59-adjuvanted influenza vaccine and 23-valent pneumococcal polysaccharide vaccine

Conditions: Influenza, Human; Pneumococcal Infections

Summary: similar to children, adults frequently visit outpatient clinics to get two or more kinds of vaccines at the same time: pneumococcal vaccine, influenza vaccine, td (diphtheria and tetanus) vaccine, hpv (human papilloma virus) vaccine, meningococcal vaccine, zoster vaccine, etc. this study is intended to evaluate the immunogenicity and safety of concomitant administration of 23-valent pneumococcal polysaccharide vaccine (ppv23, prodiax) and mf59 adjuvanted trivalent influenza vaccine in the elderly subjects aged ≥65 years.

during influenza season, concomitant influenza and pneumococcal vaccination would be an effective strategy to enhance pneumococcal vaccine coverage rate in high-risk adults. however, the immunogenicity and safety of concomitant vaccination need to be further investigated. there is data on immunogenicity and safety after concomitant administration of pneumococcal polysaccharide vaccine (ppv) and unadjuvanted influenza vaccine; no interference was noted between two vaccines. however, there are no data for mf59 adjuvanted influenza vaccine with pneumococcal vaccine. mf59 only locally reacts for immune response, so immunogenicity should be assessed for both vaccines injected in same arm versus different arms. this study is intended to evaluate the immunogenicity and safety of concomitant mf59-adjuvanted trivalent influenza vaccine (mf59-ativ, fluad) and 23-valent pneumococcal polysaccharide vaccine (ppv23, prodiax) vaccination in the elderly subjects aged ≥65 years. healthy elderly subjects (n = 424) are randomized in a 1:1:1:1 ratio to receive mf59-ativ alone (group 1), mf59-ativ +ppv23 at different arm (group 2), mf59-ativ +ppv23 at same arm (group 3) or ppv23 alone (group 4). hemagglutination inhibition (hi) assay and multiplex opsono-phagocytic killing assay (mopa) will be used to compare the immunogenicity of each vaccine after single or concomitant vaccination at pre-vaccination and 1 month post-vaccination. mopa will be taken for four serotypes (5, 6b, 18c and 19a).

Eligibility criteria:
inclusion criteria: * at least 65 years of age who are eligible for the study vaccines; * who have given written informed consent at the time of enrollment); * those who are available for all the visits scheduled in the study; * subjects in good health as determined by medical history, physical examination and clinical judgment of the investigator exclusion criteria: * history of egg allergy * history of influenza vaccination in previous 6 months * history of any pneumococcal vaccination * documented s. pneumonia infection in the previous 5 years * chemotherapy for malignancy within the past 30 days * high-dose systemic steroid (prednisone ≥0.5 mg/kg/day) in the past 30 days * receipt of blood product within 6 months before enrollment * significant acute or chronic infection within the previous 7 days or fever within the previous day * any serious chronic or progressive disease * any condition that might interfere with the study results.