Kornimate/medical-research-clean huggingface dataset:
oxytocin effectiveness in first trimester dilatation and curettage

Conditions: Missed Abortion

Summary: the aim of this study is to investigate the impact of oxytocin on perioperative blood loss during the d\&c procedure, as well as to assess early and late complications associated with it's use.

study design this study is a prospective randomized placebo-controlled double-blind trial. women undergoing dilation and curettage, who meet the eligibility criteria for the study, will be divided into two groups. they will receive the assigned medication at the beginning of the procedure, after cervical dilation but before using suction curettage. group 1: participants will receive 100 ml of saline alone. group 2: participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline. the medication bags will be prepared by the assuta ashdod university hospital pharmacy, coded with serial numbers, and randomized using computerized software. both the investigators and patients will remain unaware of the composition of the distension medium to ensure blinding. a total of 160 patients will be included in the sample size resulting in a net total of 80 patients per group as described below. patients who choose to withdraw from the study will still be analyzed as intention-to-treat patients. inclusion criteria: all patients admitted to the obgyn assuta ashdod hospital for elective surgical termination of pregnancy due to missed miscarriages in the first trimester, with gestational age range of 6.0 to 11.6 weeks. patients aged 18 years and older who are capable to provide informed consent. exclusion criteria * individual intolerance to oxytocin * mullerian anomalies * fibroid uterus * thrombophilia or coagulation disorders * cardiovascular disease primary outcome perioperative blood loss assessment: we will assess perioperative blood loss by: * measuring the content collected in the vacuum apparatus after the procedure. * recording hemoglobin and hematocrit levels prior to the procedure. * measuring hemoglobin and hematocrit levels immediately after the procedure. * monitoring hemoglobin and hematocrit levels two weeks post-procedure. secondary outcomes -perioperative complications according to the dindo-clavien scale

Eligibility criteria:
inclusion criteria: * all patients admitted to the obgyn assuta ashdod hospital for elective surgical termination of pregnancy due to missed miscarriages in the first trimester, with gestational age range of 6.0 to 11.6 weeks. patients aged 18 years and older who are capable to provide informed consent. exclusion criteria: * individual intolerance to oxytocin * mullerian anomalies * fibroid uterus * thrombophilia or coagulation disorders * cardiovascular disease

Keywords: missed abortion vaginal bleeding dilation and curretage pregnancy termination oxytocin
a study assessing iron status and anemia in filipino school children from mimaropa region

Conditions: Iron-deficiency; Iron Deficiency Anemia; Anemia

Summary: the purpose of this study is to assess the iron status and to confirm the usability of the non-invasive znpp measurement for screening the different stages of iron deficiency defined by standard measurements from blood.

brief description: the purpose of this study is to assess the iron status and to confirm the usability of the non-invasive znpp measurement for screening the different stages of iron deficiency defined by standard measurements from blood. detailed description: the primary objective of this study is to assess the iron status and the prevalence of the different stages of iron deficiency measured and defined by the standard blood iron measurements and by the non-invasive measurement of red blood cell zinc protoporphyrin fluorescence in the microcirculation of the lower lip. the secondary objective is to compare and to assess the usability of the non-invasive znpp measurement versus other standard iron status measurements from blood in distinguishing the different stages of iron deficiency. subjects will be enrolled into the study after signing an assent form in addition to having parental informed consent signed. total study duration is 1 day.

Eligibility criteria:
inclusion criteria: 1. age between 6 - 11 years old 2. having obtained his/her informed assent. 3. informed consent signed by one parent or legal authorized representative if applicable. exclusion criteria: 1. subjects or subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol 2. currently participating or having participated in another clinical trial within 4 weeks prior to trial start. 3. any disease of the lip and mouth that does not allow performing the lip measurement. 4. diagnosis of any blood disorders affecting red blood cells ( aplastic anemia, autoimmune hemolytic anemia, thalassemia) 5. diagnosis of any blood disorders affecting white blood cells (lymphoma, multiple myeloma, myeloplastic syndrome) 6. diagnosis of any blood disorders affecting platelets ( idiopathic thrombocytopenic purpura, primary thrombocythemia) 7. diagnosis of blood plasma ( hemophilia, von willebrand disease) 8. diagnosis of acute or chronic inflammatory disease (respiratory tract, digestive tract -bowel, liver, and any kidney disease) 9. diagnosis of any neoplastic disease
a large multi-center database of women who have had and are going to have surgical correction of their pelvic organ prolapse using the gynecare prolift system

Conditions: Pelvic Organ Prolapse

Summary: retrospective and prospective data collection for a database. patients will have had or are going to have a repair of their pelvic organ prolapse using the gynecare mesh prolift system


Eligibility criteria:
inclusion criteria: * women recieving surgery for their pelvic organ prolapse using the gynecare mesh kit called prolift exclusion criteria: * none

Keywords: gynecare prolift pelvic organ prolapse forming a large database of women who have recieve gynecare prolift system
impact of early goal-directed fluid therapy in septic patients undergoing emergency surgery

Conditions: Severe Sepsis; Emergency; Surgery

Summary: this study wants to compared the safety and efficacy of gdts using standard pressure-related parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in septic patients requiring emergency surgery.


Eligibility criteria:
inclusion criteria: * adults \> 18 years * severe sepsis\* as defined by the acccp/sccm consensus conference * need for emergent interventional procedure under general anesthesia with an expected duration \> 120 min (in and out patients). exclusion criteria: * patients responding to early fluid resuscitation (20ml/kg) who don't require a cvc * neurotrauma (glasgow coma score \< 12) and/ or medullar trauma * known pregnancy or diagnosed by us or ct-scan (\> 14 weeks) * sustained cardiac arrhythmia (see logbook p8) * known or diagnosed severe cardiac valvular dysfunction (stenosis, insufficiency) (see logbook p8) * known or diagnosed intracardiac shunt: interventricular or atrial defect (see logbook p8) * burn injury \> 10% * needed emergency thoracotomy or abc resuscitation protocol * pre-existing severe liver dysfunction(child-pugh class c) * do-not-resuscitate order, died within 48h of admission

Keywords: goal-directed therapy severe sepsis emergency surgery vasopressor dynamic flow-related parameters
effect of mulligans mobilization with movement in osteoarthritis knee.

Conditions: Osteo Arthritis Knee

Summary: to evaluate the effect of mulligan's mobilization with movement in osteoarthritis of the knee.

patients with knee oa diagnosed at the orthopaedic clinic of tumair general hospital and referred to the physiotherapy department who attended the rehabilitation centre of majmaah university will be recruited. patients will be excluded if they had knee or hip injury, sensory deficits in the lower extremity, a history of lower-extremity surgery, or a history of a quadriceps or hamstring muscle injury, had low back-related leg pain, or had any contraindication to manual therapy. the protocol was submitted to and approved by the majmaah university research ethics committee (murec dec.2/ com-2021/19-3) participants will be requested to sign a written informed consent form approved by the institutional ethics committee. a total of 60 participants were randomly assigned to group a (experimental group): mulligan's mobilization with movement mwm added isometric strength training, and group b (control group): sham mwm added isometric strength training. pre and post-test readings were taken at baseline, week 2, and week 4, respectively. the outcome measures for this study will be maximal voluntary isometric contraction of quadriceps strength (measured by isomove dynamometer), rom, and western ontario and mcmaster universities osteoarthritis (womac) index.

Eligibility criteria:
inclusion criteria: * patient with knee oa with radiological evidence of grade 2 or 3 of the kellgren and lawrence scale. * age between 40-65 years, unilateral or bilateral involvement (in the case of bilateral involvement, the more symptomatic knee was included), and pain in and around the knee. exclusion criteria: * patient will be excluded, if they had any deformity of the knee, hip, or back, had any central or peripheral nervous system involvement. * they had received steroids or intra-articular injection within the previous three months, uncooperative patients.

Keywords: isometric exercise osteoarthritis rehabilitation
study of the safety and efficacy of ferrlecit® maintenance dosing in pediatric hemodialysis patients

Conditions: Anemia

Summary: a phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal guardian had provided signed informed consent, and who had satisfied the inclusion and exclusion criteria of the study.


Eligibility criteria:
inclusion criteria: * male or female pediatric esrd, patients \>_ 2 and \<_ 16 years of age, whose legally authorized representative provided signed informed consent. * stabilized on chronic hemodialysis therapy with an identified need for maintenance iron therapy. * predetermined tsat and serum ferritin (at the screening visit). * receiving a stable epo dosing regimen. exclusion criteria: * receipt of any form of iron supplementation during the 2 weeks prior to the first ferrlecit dosing. * hypersensitivity to ferrlecit or any of its inactive components. * high tsat level. * high serum ferritin

Keywords: anemia
assure wcd clinical evaluation - post approval study (ace-pas)

Conditions: Sudden Cardiac Arrest

Summary: active surveillance study using real-world data collected in the assure patient registry. outcome measures are based on analysis of assure registry data including data recorded by the wcd then annotated by clinical experts in electrophysiology.


Eligibility criteria:
inclusion criteria: * adult patient prescribed the assure wearable cardioverter defibrillator * provided written informed consent to participate in the assure patient registry exclusion criteria: * patients who do not meet the inclusion criteria
clinical utility of a new silver gel for use on chronic wounds

Conditions: Chronic Wounds

Summary: this investigation will be conducted in the us as a single-center study to evaluate in total 10 subjects, to explore the clinical utility of a new silver gel for use on chronic wounds.

both inpatients and outpatients will be included in this study. the patients will present with chronic wounds in need of initial treatment prior to initiating standard of care (i.e. wound bed with eschar or slough), in need of treatment after debridement or with presenting inflammation along with need for treatment.only one wound will be chosen for treatment in the study and the area should not exceed 10x10 cm and not be deeper than 6 cm. photos of the wound will be taken at each visit.

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. both genders with an age \>18 years 3. subjects with chronic wounds \< 1 year chronicity that are assessed as having localized infection or inflammation (i.e. not felt to have systemic involvement) as indicated by the presence of at least 2 of the following clinical signs of infection: * erythema * edema * warmth * increased drainage * foul odor 4. subject's wounds may also present with: * presence of eschar or slough that needs to be treated prior to normal standard of care or * a need for topical care after debridement 5. study site to include only one wound to be treated exclusion criteria: 1. presence of fever with 2 or more clinical signs of infection that in the opinion of the investigator is indicative of a more systemic type infection. 2. use of anti-microbial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days 3. wound \> 1 year old 4. wound \> 10 cm x 10 cm (l x w) 5. wound \> 6 cm deep 6. use of chemical/enzymatic and biological debridement within 7 days of investigation start 7. necrotizing wounds 8. diagnosed underlying disease(s) (e.g. hiv/aids, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment. 9. subjects with poorly controlled diabetes mellitus (as judged by the investigator). 10. subjects treated with systemic glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisone/day or equivalent. 11. known allergy/hypersensitivity to any of the components of the investigation products. 12. subjects with physical and/or mental conditions that are not expected to comply with the investigation, including subjects totally confined to bed. 13. participation in other clinical investigation(s) within 1 month prior to previously randomized to this investigation
study of talabostat and rituximab in advanced chronic lymphocytic leukemia (cll)

Conditions: Chronic Lymphocytic Leukemia

Summary: the objective of this study is to assess the efficacy and safety of talabostat and rituximab in patients with advanced cll who failed to respond, or have progressed following a prior response, to a fludarabine regimen.

completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
inclusion criteria: * men or women ≥18 years of age * histopathologically confirmed diagnosis of b-cll expressing surface cd20 of any detectable intensity * rai stage iii or iv. rai stages i and ii with massive or progressive lymphadenopathy or hepatosplenomegaly. * primary resistance to a fludarabine regimen (no pr or cr) or progressive disease within 1 year of a prior response * ecog performance status 0, 1, or 2 * written informed consent exclusion criteria: * therapy for cll within 4 weeks of study day 1 (including chemotherapy, radiation, immunotherapy, cytokine or biologic \[with the exception of hematopoietic growth factors\]). patients must have recovered from the adverse effects of prior therapy. * known primary or secondary malignancy of the central nervous system * any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix * serum creatinine \>2.0mg/dl (\>176 micromol/l) * ast or alt ≥3 x the upper limit of normal (uln) * total bilirubin ≥1.5 x uln (unless secondary to gilbert's) * positive serology for hepatitis b (hbsag) or hepatitis c (anti-hcv antibody) * known positivity for hiv * prior organ allograft * concurrent comorbid medical conditions that, in the opinion of the investigator, preclude the safe delivery of the experimental treatment * pregnant or nursing women
safety and immunogenicity of intradermal versus subcutaneous doses of menomune®

Conditions: Meningococcal Infections; Meningitis

Summary: the objective of this trial is to study the administration of the menomune vaccine given intradermally and low-dose subcutaneously versus standard subcutaneously. this study will describe the immunogenicity of menomune® - a/c/y/w-135 administered subcutaneously (standard dose) versus intradermally over a dose range (1/10th, 2/10th, and 3/10th of standard dose) and a low dose (2/10th of standard dose) subcutaneously. the secondary objective is to describe the safety of the subcutaneous (sc) and intradermal (id) routes at different dosages

this trial will provide a proof of concept that a dose range of menomune given id can induce an immune response that is comparable to standard dosing by the sc route, and is equivalent or superior to a low dose given sc. subjects will be randomized according to a computer-generated randomization schedule to receive the vaccine by sc injection or by id injection at different dosages.

Eligibility criteria:
inclusion criteria : * 18 to 55 years of age. * willing to return for 3 follow-up visits and comply with a 30 day follow-up period. * signed an informed consent form. exclusion criteria : * allergy to any component of the vaccine and latex. * known or suspected immunodeficiency or receipt of immunosuppressive therapy or blood products within the previous two months. * history of serious chronic diseases (such as cardiac or renal disease). * acute febrile illness at the time of visit. * pregnancy. * receipt of any vaccine within the 28 days prior to enrollment. * receipt of meningococcal vaccine (example in military) within the past 5 years or history of meningococcal disease.

Keywords: menomune® - a/c/y/w-135 meningococcal infections meningitis
non-insulin dependent diabetes mellitus (niddm) and angiotensin converting enzyme 2 (ace2): diabetic patients treated with antihypertensive drugs

Conditions: NIDDM

Summary: this feasibility study is designed to examine modulation of the relative activities of ace and ace2 in diabetic patients following treatment with the angiotensin type 1 receptor (at1r) antagonist, candesartan. this study will provide a closer insight to the possible involvement of the renin-angiotensin system (ras)-related enzymatic components in development or attenuation of vascular pathogenesis.


Eligibility criteria:
inclusion criteria: * signed informed consent * non-smokers * type ii dm diagnosed patients * blood pressure \< 135/90 * serum hba1c \> 7% * serum creatinine \< 1mg% * urine microalbumin \< 300 mg/day * body mass index (bmi) \< 35 kg/m2 exclusion criteria: * insulin-dependent diabetic patients * patient with persistent microalbuminuria * patient with history of severe hypertension * congestive heart failure * patient receiving renin-angiotensin-aldosterone system (raas)-related anti-hypertensive medications. * patient with major hepatic disease

Keywords: niddm ace2 niddm patients
relationship between a combined index of diastolic and systolic performance and intraoperative hemodynamic changes during off-pump coronary bypass surgery

Conditions: Coronary Artery Obstructive Disease

Summary: as considering the close relationship between systolic dysfunction and diastolic dysfunction, the eas index e'/(a' x s') including systolic and diastolic function could be expected to predict hemodynamic changes during off-pump coronary artery bypass surgery(opcab). exposure of the grafting site during opcab needs displacement of the heart, resulting in hemodynamic instability. therefore the investigators are going to evaluate eas index with preoperative transthoracic echocardiography(tte) and want to know the relationship between preoperative eas index and intraoperative hemodynamic changes in patients undergoing opcab, in a prospective observational study.


Eligibility criteria:
inclusion criteria: 1. age ≥ 20 2. patients undergoing multivessel off-pump coronary artery bypass surgery exclusion criteria: 1. age \< 20 2. patients with valvular heart disease 3. congestive heart failure, nyha class ≥iii 4. emergency surgery 5. patients with arrhythmia 6. st segment elevation myocardial infarction
comprehensive analyses of multidetector-row cardiac computed tomography data in koreans

Conditions: Coronary Disease

Summary: 64 channel multidetector-row computed tomography (ct) has been introduced for use in the diagnosis of coronary heart disease. the investigators aimed to characterize coronary artery disease in type 2 diabetes mellitus and metabolic syndrome, and in particular plaque natures depending on different status of metabolic diseases. the investigators also aimed to analyze the risk factors associated with number and severity of stenosis as well as plaque characteristics using logistic regression models.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older exclusion criteria: * pregnant women * patients with chronic kidney disease (cr\>2.0)

Keywords: coronary heart disease multidetector row cardiac computed tomography type 2 diabetes metabolic syndrome
a study of cs1001 in subjects with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a phase i, open-label, multiple-dose, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of cs1001 in subjects with advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. subjects with metastatic or locally advanced unresectable solid tumor, who progressed following treatment with all available standard therapy, or for whom treatment is not available, not tolerated or refused. 2. ecog performance status of 0 or 1. 3. subjects must have at least one measurable lesion. 4. patients with life expectancy ≥ 3 months. 5. subject must have adequate organ function. 6. fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after last study drug administration. exclusion criteria: 1. known brain metastasis or other cns metastasis that is either symptomatic or untreated. 2. subjects with active autoimmune diseases or history of autoimmune diseases should be excluded. 3. patients who have received prior therapies targeting pd-1, pd-l1, or ctla-4. 4. known history of hiv infection. 5. subjects with active hepatitis b or c infection. 6. any unresolved ctcae grade ≥ 2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia. 7. patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma. 8. known history of alcoholism or drugs abuse. 9. subjects who received organ transplantation. 10. known psychiatric disorders that would interfere with cooperation with the requirements of the trial. 11. female subjects who are pregnant or breast-feeding; male or female subjects of childbearing potential who refuse to use an effective method of birth control. for more information regarding trial participation, please contact at cstonera@cstonepharma.com