Kornimate/medical-research-clean huggingface dataset:
pilot trial of backwards walking in persons with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: there have been no published studies to date on the effects of backwards walking in persons with ms. thus it is important that the investigators explore different methods for treatment to help improve balance and gait and prevent injury in persons with ms with gait disturbances and balance impairments.the overall goal of this research is to collect pilot data on the effectiveness of backwards walking as a therapy for improving spatiotemporal, clinical gait and balance assessments in persons with multiple sclerosis compared to forward walking.


Eligibility criteria:
inclusion criteria: * confirmed clinical diagnosis of ms * cognitively able to understand directions and complete protocol (score of 22 or greater on mmse) * signed consent form approved by the saint francis institutional review board * 18-65 years of age * pdds score of 3 to 5 during the past 12 months * completion of the 6 minute walk test * speaks english (in order to safely complete intervention) exclusion criteria: * unwilling or unable to complete assessments and intervention * current participation in physical therapy * major changes in exercise habits in the past three months * has had a relapse, acute solumedrol treatment, or acthar treatment in the past two months * requires constant bilateral assistance (canes or crutches) for ambulation and/or cannot walk at least 100 meters without resting * current self-reported medical history of unstable angina, uncontrolled cardiac dysrhythmias causing symptoms, symptomatic severe aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus or pulmonary infarction, history of dvt, acute myocarditis or pericarditis, acute systemic infection, uncontrolled hypertension, and uncontrolled diabetes \[11\] * participants that cannot adhere to the protocol, have an abnormal response to exercise, or is determined to be unsafe may be withdrawn at the discretion of the principal investigator
in vitro myometrial contractions in laboring and non-laboring women

Conditions: Postpartum Hemorrhage

Summary: the purpose of this study is to compare the ability of an isolated sample of uterine muscle tissue (in a tissue bath) to contract in the presence of various drugs. the drugs studied--uterotonics--are typically used to contract the uterus when a pregnant patient continues to bleed after delivery. amongst common uterotonic drugs, namely oxytocin, ergonovine, prostaglandin f2alpha, and misoprostol, the most effective one to use is unknown. the investigators will be testing isolated uterine muscle samples to increasing concentrations of these four drugs in three patient populations: non-laboring, laboring without exogenous oxytocin augmentation, and laboring with oxytocin augmentation. contractile measures will be measured and compared between all groups. the investigators hypothesize that oxytocin alone will have a weaker uterotonic effect in oxytocin-augmented laboring patients, and all four drugs will induce different patterns of contractions.

postpartum hemorrhage (pph) is a major cause of maternal mortality and morbidity. in 80% cases of pph, the primary cause is failure of the uterus to contract after delivery of the baby, which then requires further treatment of the mother with uterotonic drugs (drugs used to contract uterus and thus prevent bleeding). patients participating in this study will be asked to donate a very small sample of uterine tissue during cesarean section, which will be tested in the laboratory for the ability to contract in response to the uterotonics oxytocin, ergonovine, prostaglandin f2alpha, and misoprostol. we will seek to better understand the effects of these drugs by comparing their contractile capability in isolated uterine tissue.

Eligibility criteria:
inclusion criteria: * gestational age 37-41 weeks * patients requiring primary or first repeat cesarean section * cesarean section under spinal anesthesia exclusion criteria: * patients who require general anesthesia * patient who had previous myometrial surgery or more than one previous cesarean section * patients with placental anomalies * patients with multiple pregnancy (twins, etc.)

Keywords: uterine contraction dose response non-laboring laboring laboring with oxytocin augmentation oxytocin ergonovine prostaglandin f2alpha misoprostol
efficacy and safety of finerenone in patients with primary membranous nephropathy

Conditions: Primary Membranous Nephropathy

Summary: this is a prospective, randomized, multicenter, double-blinded, placebo-controlled trial. eighty-eight patients with primary membranous nephropathy (pmn) will be randomly divided into the intervention and control groups. the intervention group will be administered maximum tolerable dose of acei/arb and finerenone 20 mg qd. control patients will be administered maximum tolerable dose of acei/arb and a placebo. the primary endpoint is the relative change in urinary protein content from baseline to 6 months.

after more than 4 weeks of maximum tolerated dose of acei/arb, the patients will be randomly divided into the control and intervention groups in a 1:1 ratio in a double-blinded manner. the intervention group will then be administered finerenone 20 mg qd, while control cases will receive a placebo.

Eligibility criteria:
inclusion criteria: * adults (age≥18,and ≤75) with primary mn. * administration of the maximum tolerable dose of acei/arb for ≥4 weeks. * bp ≤140/90 mmhg. * urine protein content of 1.0-5.0 g/d. * egfr ≥60 (ckd-epi). * postmenopausal or postoperatively infertile status or on medical contraception (considering the potential risk of thromboembolism in patients with kidney disease) in women. * voluntary signing of informed consent. exclusion criteria: * type 1 or type 2 diabetes. patients with a recent history of steroid-induced diabetes were eligible with renal biopsy showing no evidence of secondary diabetic nephropathy within 6 months before the screening period. * patients with secondary membranous nephropathy (e.g., due to hepatitis b and c, systemic lupus erythematosus, drug therapy, malignant tumors and other secondary causes). * uncontrolled arterial hypertension. * treatment with glucocorticoids, immunosuppressants and/or biological agents in the past 6 months. * treatment with any other study drug within the last month. * females with a positive pregnancy screening test, lactating or planning to become pregnant in the next 24 months. female or male patients unwilling to use contraceptive methods throughout the study. * a history of mental illness. * laboratory tests meeting the following criteria: 1. hemoglobin levels \<80 g/l; 2. platelet count \<80×109/l; 3. neutrophil count \<1.0×109/l; 4. aspartate aminotransferase (ast) or amino aminotransferase (alt) \>2.5 times the upper limit of normal, except in relation to the primary disease. * very high-risk cases (life-threatening nephrotic syndrome or unexplained rapid deterioration of renal function). * unsuitability for inclusion in the trial as judged by the investigator.

Keywords: finerenone urinary protein
the effect of online based mentoring program on the blood glucose and satisfaction score in type 1 diabetes patients

Conditions: Type 1 Diabetes

Summary: purpose: to evaluate the effects of online based mentoring program on the blood glucose and satisfaction score in type 1 diabetes patients. peer group mentoring will be as effective as guidance by the doctors. methods: 80 type 1 patients will be randomly divided into two groups (e.g. mentoring program group and control group). all patients will receive routine check up and blood test for ordinary type 1 patients. in addition, program group patients should register their smbg, exercise, food intake and insulin dose on the website designed for this study and receive advices of mentors from peer group. every patient will submit questionnaire on the first day of the study and the last day(after 12 weeks) of the study.

subjects with t1dm on intensive insulin therapy and with hemoglobin a1c (hba1c) ≥8.0% were randomized to mentored (glucometer transmission with feedback from mentors) or control (glucometer transmission without feedback) groups and were examined for 12 weeks. five mentors were interviewed and selected, of which two were t1dm patients themselves and three were parents with at least one child diagnosed with t1dm since more than 5 years ago.

Eligibility criteria:
inclusion criteria: * age \> 18, more than 6 month after the diagnosis of type 1 diabetes * hba1c \> 8% despite of multiple insulin injection or insulin pump * who are capable of using the internet exclusion criteria: * pregnant women * who cannot use the internet * those who does not want to participate in the study

Keywords: online based mentoring program, type 1 diabetes, blood glucose, satisfaction score
investigating the efficacy and safety of roxadustat (fg-4592) for treatment of anemia in pediatric patients with ckd

Conditions: Anemia Associated With Chronic Kidney Disease

Summary: this open-labeled, one-center study is designed to evaluate the efficacy and safety of roxadustat in esa-naïve and esa-treated pediatric patients with ckd stages 3, 4, and 5 who are receiving dialysis or not. the study will enroll patients between the ages of 2 to \<18 years. approximately 30 patients will be enrolled.

this study is to evaluate the use of roxadustat for renal anemia in pediatric patients with ckd

Eligibility criteria:
inclusion criteria: 1. estimated glomerular filtration rate (bedside schwartz formula) of \< 60 ml/min/1.73 m2 (stage 3, 4 and 5 ckd) for dialysis or non-dialysis patients. 2. for esa-naïve patients, mean of two most recent central laboratory hb values during the screening period obtained at least 2 days apart must be \< 11.0 g/dl. for patients currently receiving stable esa dosing who will discontinue esa and convert to roxadustat during study, mean of two most recent central laboratory hb values during the screening period obtained at least 2 days apart must be ≥ 9.0 g/dl and ≤ 12.5 g/dl 3. ferritin \>50 ng/ml and transferrin saturation \>10% exclusion criteria: 1. uncontrolled hypertension as judged by the principal investigator prior to screening. 2. known hematologic disease related anemia (including prca) 3. known malignancy within the past 5 years before screening. 4. history of severe anaphylaxis or known allergic to ingredient of roxadusta. 5. alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 3x upper limit of normal (uln) and total bilirubin (tbili) ≤2x uln(obtained from screening visit). 6. serum folate and vitamin b12 \> lln and cannot be corrected (obtained from screening visit). 7. any rbc transfusion during the past 4 weeks before screening. 8. weight\<10kg 9. any prior exposure to roxadustat or any other hif-ph inhibitor.
compare the hemostatic effectiveness of chitosan gauze with traditional gauze on open wound on 10 participants.

Conditions: Hemostasis

Summary: this study recruited 10 subject participants to compare the hemostasis gauze made by chitosan with traditional cotton gauze to see which one is better in bleeding time, bleeding volume, wound infection and wound healing speed when it is used in open wound treatment.

open wound bleeding and infection care policy development is focusing on efficiency to strengthen internal bleeding, pain, avoidance of infection and promoting wound healing wound. with the changes in the social environment, people caring for hemostasis and wound healing have become increasingly demanding. presently, studies generally aim to stop the bleeding using trauma care technology and functional capabilities combined with each other as well as inhibit lower infection and can also help assist healing wounds care strategy for the protection of human lives. therefore, the goal of the plan is to establish new care strategies on open wounds infection to stop the bleeding and to improve the health and safety of the people. the researchers will choose the general biological hemostatic gauze to conduct clinical trials comparing the clinical hemostasis focusing on bleeding time, wound infection in the wound and the wound bacteria penetrating situations in the hope to build a better strategy in rapid hemostasis and wound infection care strategy.

Eligibility criteria:
inclusion criteria: * patients need laparotomy, with the expected wound size bigger than 5 cm in length and 2 cm in width. exclusion criteria: * have history of allergy to shrimp, crab and other chitins. * patients with blood clotting disorders * vulnerable group * patients with unstable vital sign

Keywords: bleeding wounds, hemostasis, open wounds, infection, antimicrobial
thromboelastometry in assessment of sepsis coagulopathy

Conditions: Thrombelastography; Sepsis

Summary: the purpose of this study is to analyze occurence of bleeding complications during invasive procedures in septic patients with normal tromboelastometry results despite prolonged standard coagulation tests results


Eligibility criteria:
inclusion criteria: * sepsis/septic shock * prolonged pt-inr (international normalized ratio) ≥ 1.3 * normal rotem-extem results. exclusion criteria: * patients on antiplatelet drugs or anticoagulant therapy (heparin, vitamin k antagonists...) * patients with cirrhosis
the impact of the biopsy of 1-2 cells in a pgd program for anueploidy screening

Conditions: Healthy

Summary: the aim of this study is to evaluate the impact of the biopsy of one or two cells in a preimplantatation genetic diagnosis program (pgd) for the screening of aneuploidies. this prospective and randomized study will be performed at the instituto valenciano de infertilidad in valencia (spain) in those patientes included in our clinical program. our purpose is to optimize the methodology employed in our laboratory in order to guarantee optimal implantation and pregnancy rates without a detrimental effect on the accuracy and efficiency of the cytogenetic analysis. patients will undergo and ivf cycle, embryo biopsy will be performed on day 3 embryos in two fashions: in some patients only one cell per embryo will be retrieved whereas in others, 2 cells will be retrieved in good morphology embryos and only 1 in the slowl ones. in all cases aneuploidy screening will be performed by fish for chromosomes 13, 16, 18, 21, 22, x and y. embryo developmente will be checked every 24 hours and chormosomally normal embryos will be replaced into the uterus on day 5 of development.


Eligibility criteria:
inclusion criteria: * patients undergoing pgd for aneuploidy screening with their own oocytes and for chromosomes 13, 16, 18, 21, 22, x \& y exclusion criteria: * patients undergoing pgd for monogenic diseases (pcr) * patients undergoing pgd for structural chromosomal abnormalities * ovum donation cycles * cryopreserved oocyte/embryos

Keywords: pregnancy and implantation rates efficiency and accuracy of the genetic testing
equity in modifying plaque of women with undertreated calcified coronary artery disease

Conditions: Coronary Artery Disease

Summary: post-market, prospective, multi-center, single-arm observational study to generate real-world clinical evidence associated with coronary ivl in a population of female subjects with calcified coronary artery disease.

subject population: up to 400 female subjects referred for percutaneous coronary intervention (pci) with coronary ivl and stenting per standard of care at up to 50 global sites in the us, uk and europe. subjects will have clinical follow-up prior to discharge from the index intervention and at 30 days, 1, 2 and 3 years.

Eligibility criteria:
inclusion criteria: 1. the subject is a non-pregnant female ≥18 years of age 2. the subject meets indications for pci and stent 3. the subject is scheduled to undergo pci with coronary ivl and stenting per standard of care for non-stented lesion 4. the subject is willing to comply with protocol-specified follow-up evaluations 5. the subject, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate institutional review board (irb) or ethics committee (ec) exclusion criteria: 1. subjects with known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year 2. subjects presenting with cardiogenic shock at the time of the index procedure 3. serious angiographic complication in the target vessel prior to treatment with coronary ivl including-severe dissection (type d to f), perforation, abrupt closure, persistent slow-flow or persistent no reflow 4. subject unable to tolerate anticoagulation/antiplatelet therapy per guidelines 5. subject is enrolled in any study of an investigational device or drug that may interfere with study results

Keywords: intravascular lithotripsy percutaneous coronary intervention
300 antibody diagnostic test kit

Conditions: Acute Bacterial Infections; Acute Viral Infections

Summary: for the development of a point of care ivd test kit for acute phase disease detection against a variety of bacterial and viral infections. phase one includes 100 clinical diagnosed positive and 200 clinically "normal" serum and whole blood matched specimens for specificity and sensitivity determination for each marker. the positive samples must be igm positive using any fda cleared elisa test kit. the negatives samples must be negative for igm.


Eligibility criteria:
inclusion criteria: * current acute infection * age 18-70 * male or female * any race * currently active symptoms

Keywords: cytomegalovirus (cmv) igm &igg lyme toxoplasma rubella rubeola igm rocky mountain spotted fever igm ebv igm herpes babesia measles tetanus mumps mycoplasma legionella giardia syphilis bordetella pertussis h pylori antibody titre elevated igg abnormal igm sle
development of a web-based interactive patient decision aid for the treatment of acute low back pain and depression

Conditions: Acute Low Back Pain; Depression

Summary: shared decision making (sdm) has been advocated as an appropriate approach for physician patient communication. positive effects of sdm are e.g higher patient satisfaction, greater treatment adherence, lower decisional conflict and better clinical outcomes. the section of clinical epidemiology and health services research at the university medical center in freiburg (germany) is developing and evaluating a web-based interactive decision aid ("patient dialogue") to support shared decision making in cooperation with the techniker krankenkasse, a large german health insurance company. both development and evaluation are conducted along the international patient decision aid standards (ipdas). the decision aid contains information on acute low back pain and depression and addresses insurance members who are facing a treatment decision in one of the indications. it aims at the development of patient competencies for participating in decision making, the support of constructive health behavior and patients' acceptance of evidence based treatment options. in an rct the decision aid will be compared to a regular patient information on a sample of n=500 patients in each group. data collection will take place at three points of time: before and after use of the decision aid as well as 3 months later.


Eligibility criteria:
inclusion criteria: * insurance members with acute low back pain or depression exclusion criteria: * insurance members without symptoms, with chronic back pain, with a bipolar disorder, relatives of people with symptoms
taste disturbance after middle ear surgery: frequency, duration, influence of chorda tympani injury and quality of life

Conditions: Ear Middle Problems

Summary: chorda tympani nerve (ctn), is a branch of nerve vii, and has two componants: taste sensation from the anterior two thirds of the tongue and salivary secretion from submandibular and sublingual salivary glands. ctn go throw middle ear between malleus and incus. due to it anatomic localization, ctn is frequently damage during otologic surgery. taste disturbance after middle ear surgery has been describe in literature but results of the various studies are very heterogenous. moreover, there is no consensus to preserved or sacrificed a traumatize ctn. we will use questionnaire to evaluate frequency, duration and characteristics of taste disturbance after ear surgery and the impact on the quality of life for those with symptoms. we will evaluate the influence of type of ctn injury on taste disturbance.


Eligibility criteria:
inclusion criteria: * patient undergoing middle ear surgery * acceptation to participate * under 18 years old, parental authorization. exclusion criteria: * taste disturbance before surgery * patients with guardianship or tutelage measure
ulinastatin injection in in pediatric patients undergoing open heart surgery

Conditions: Congenital Heart Diseases

Summary: 1. explore the efficacy of ulinastatin use in improving post-operative pulmonary insufficiency and safety in pediatric patients undergoing scheduled cpb open heart surgery to treat complex congenital heart disease 2. explore the efficacy of ulinastatin use in improving intraoperative hemodynamic instability as well as other post-operative organ recuperation and its impact on hospital stay \& cost

pediatric patients diagnosed with complex congenital heart disease ready to accept scheduled open-heart surgery under cardiopulmonary bypass (cpb). this study uses randomized (centralized randomization) \& controlled design with open label. eligible subjects will be randomized to receive either study drug (ulinastatin) or conventional treatment.

Eligibility criteria:
inclusion criteria: 1. children diagnosed with complex congenital heart disease . 2. hospitalized children, both gender, aged ≥ 30 days to ≤ 4 years. 3. preoperative assessment meet with surgical condition. 4. without signs of liver, kidney, and coagulatory dysfunction. 5. written informed consent form has been signed by the legal guardian. exclusion criteria: 1. patients will accept minimally invasive surgery or palliative surgery, as well as major aortopulmonary collateral arteries (mapcas); 2. its decided that subject needs to undergo second surgery in a short period of time, or underwent other major surgery. 3. subjects with known hypersensitivity to study medication (ulinastatin for injection) or patients with highly allergic history. 4. though meeting the study inclusion criteria, the legal guardian reject to sign on informed consent. or at the discretion of study investigator/coinvestigator that the subjects is not appropriate to be included in the study.

Keywords: ulinastatin cpb pediatric