Kornimate/medical-research-clean huggingface dataset:
intravenous treatment of anemia in pregnancy

Conditions: Anemia

Summary: the investigators assess and compare the efficacy of anemia treatment in pregnant women with anemia of chronic disease with true iron deficiency and in women with iron deficiency anemia.

fifty anemic pregnant women with moderate anemia were prospectively observed and treated in the anemia clinic at the department of obstetrics, university hospital zurich. all patients had singleton pregnancies. all pregnant women fulfilled criteria of moderate iron deficiency anemia defined as hemoglobin (hb) between 8.0 and 9.9 g/dl and serum ferritin \<15 μg/l. in all women, the analyses of a blood count, iron status, erythropoietin, cross reactive protein (crp), folic acid and vitamin b12 were conducted. according to hemoglobin level at the start of the therapy, the women were either treated with intravenous iron and rhepo or with intravenous iron only twice weekly. patients with an hb level between 9.0 and 9.9 g/dl (33 patients) received 200 mg iron sucrose (venofer®, vifor int., st. gallen, switzerland) intravenously twice weekly (group a). if response to therapy was poor (i.e. hb increase \<0.7 g/dl) after 2 weeks (13 patients), patients additionally received rhepo (10,000 u eprex®, janssen-cilag, baar, switzerland) (group b). this cut-off for adequate primary response the investigators choose on the basis of previous experience. patients with an hb between 8.0 and 8.9 g/dl (17 patients) received iron sucrose (venofer) and rhepo (eprex) twice weekly from the start of therapy (group c). sufficient overall response to therapy (the difference of baseline hemoglobin and after therapy) was defined as hb increase \>1.0 g/dl. the maximum total iron dose was 1,600 mg, therefore therapy was stopped if the maximal iron sucrose dose was administered, or target hb \> 10.5 g/dl was achieved.

Eligibility criteria:
inclusion criteria: * pregnant women with hemoglobin between 8.0 and 9.9 g/dl and serum ferritin \<15 μg/l exclusion criteria: * vitamin b12 deficiency anemia * folic acid deficiency anemia * hemoglobinopathy * multiples * liver disease * kidney disease
web-based resource for children and adolescents about clinical research

Conditions: Healthy; Chronic Illnesses, Multiple

Summary: the overall aims of this project are to: 1) create a developmentally appropriate interactive educational website for adolescents called digiknowit news: teen, and 2) examine the feasibility of digiknowit news: teen in a small randomized control trial with adolescents.

youth (n=30) will be recruited to participate in the feasibility study. parent permission and youth assent will be sought. participants will be randomized into one of two study arms: intervention and wait-list control. all participants will complete a web-based pre-test questionnaire. youth in the intervention group will then receive access to digiknowit news: teen for one week. approximately one week after completing the pre-test questionnaire, all participants will complete a web-based post-test questionnaire (the post-test for youth in the intervention group will also include consumer satisfaction questions). youth in the wait-list control group will then receive access to digiknowit news: teen for one week. after one week, they will complete a consumer satisfaction questionnaire.

Eligibility criteria:
inclusion criteria: * participants must be between the ages of 12 and 17 years. * participants must have access to a computer or tablet with internet connection. * participants must be able to read and write in english fluently. exclusion criteria: * participants must not have previously participated in a clinical trial.
study on the impact of stem cell donation and bone marrow harvesting on unrelated donors

Conditions: Chromosome Aberrations

Summary: granulocyte colony stimulating factor (gcsf) is used extensively as a means of mobilising donor peripheral blood stem cells as an alternative to bone marrow harvesting for the purpose of recipient stem cell transplantation. the principal objective of the research is to study any longterm genetic effects of gcsf in the peripheral blood white cells of unrelated blood stem cell donors. the study subjects will be retrospective and prospective voluntary unrelated donors on the anthony nolan bone marrow registry being harvested at the royal free hospital and university college hospital, london and british bone marrow registry donors harvested at the royal free hospital and bupa glen vale in bristol. all participants in the prospective arm will be asked to donate one 5-10ml sample of blood at study entry prior to stem cell donation and further samples at 120 and 360 days post donation. those found to carry aneuploid cell clones at these time points will be asked for a further 5-10ml blood sample at least twice - at the end of 24 months and 36 months respectively. the retrospective and positive control group will be asked to supply one 5-10ml sample of blood.

the aim of this study is to detect any genetic differences between bone marrow and pbsc unrelated donors, post donation and confirm or refute the observations of "long-term genetic or epigenetic effects" published by nagler et al\[nagler,a. et al. exp.haem (2004) 32;122-30\]. the employment of more sensitive methods such as ifish and gene array analysis to assess any permanent genetic changes, our primary objective, will make our study more robust. there will be two arms: i) retrospective arm - the peripheral blood of unrelated donors who donated 3 to 5 years previously will be screened. ii) prospective arm - peripheral blood of unrelated donors will be examined prior to donation and at 120 and 360 day's post-donation. in those found to have aneuploid changes at these time points, there will be additional sampling at 24 and 36 months and if necessary these donors will be followed up. each arm of the study will include 50 bm unrelated donors and 50 pbsc unrelated donors giving a total sample population of around 200 unrelated donors. there will be one positive control group of 50 patients with a range of haematological malignancies. the blood samples taken from both bm and pbsc donors prior to donation will act as internal negative controls.

Eligibility criteria:
inclusion criteria: donors of peripheral blood stem cells exclusion criteria: relatives suffering from blood cancer
feasibility and safety of umbilical cord blood transfusion in the treatment of neonatal cerebral ischemia and anemia

Conditions: Hypoxic-Ischemic Encephalopathy; Hypoxia Neonatal; Cerebral Ischemia of Newborn; Anemia, Neonatal

Summary: the study is to investigate the feasibility and safety of autologous umbilical cord blood transfusion to treat the newborn infants with presence of clinical indications of neonatal hypoxic-ischemia encephalopathy (hie) and anemia. umbilical cord blood (ucb) is collected following labor and is transfused intravenously within 48 hours after the birth. newborn infant without ucb available recieves the standard care will be enrolled as control group. following the autologous ucb transfusion in the study group or standard care in the control group, hie subjects will be followed for 2 years for survival and neurodevelopmental outcomes and anemia subjects will be followed for 6 months to assess the survival and change of hematocrit and hemoglobin levels.


Eligibility criteria:
inclusion criteria: * evidence of asphyxiation, defined by 5-minute apgar score ≤ 5; * evidence of hie, defined by ucb ph \<7.15 or base excess ≤ 10mm; * subjects with hie confirmed by clinical features and initial investigations; * subjects with evidence of anemia, defined by hematocrit \< 40% or hemoglobin ≤ 13g/dl within the first 96 hours of life; * obtain the informed consent from parents exclusion criteria: * congestive cardiac failure; * microcephaly, anencephaly, encephalocele, or other abnormality * conjoint twins; * chromosomal disorders * fetal alcohol syndrome * spinal bifida or other neural tube defects * subjects have other neurological deficit conditions * polycythemia * congenital hematological malignancy * investigator decision

Keywords: umbilical cord blood
endoscopic abraxane injection into pancreatic cysts

Conditions: Pancreatic Cysts

Summary: this research study is a pilot study. in this pilot study we are testing the safety of a procedure. "investigational" means that the albumin bound paclitaxel (abraxane) is still being studied and that research doctors are trying to find out more about it. it also means that the fda has not approved abraxane injection for your type of medical condition. treatment of pancreatic cysts often requires follow-up imaging studies and surgical resection of the cysts. as part of standard medical care, you will be undergoing a diagnostic endoscopic ultrasound guided fine needle aspiration (eus-fna) in order to evaluate type of the cyst. during the eus and just after the cyst fluid aspiration, you will undergo the injection of the drug into the cyst cavity if your cyst is thought to be cancerous or precancerous. cyst fluid will be analyzed for further diagnosis.

you will be asked to undergo some screening tests or procedures to find out if you can be in the research study. many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. if you have had some of these tests or procedures recently, they may or may not have to be repeated. screening tests include the following: medical history, performance status, assessment of pancreatic cyst by ct, mri or eus, blood tests and a pregnancy test. if these tests show that you are eligible to participate in the research study, you will begin the study treatment. if you do not meet the eligibility criteria you will not be able to participate in this research study. as part of your medical care you will be undergoing an endoscopic procedure eus-fna (endoscopic ultrasound fine needle aspiration) in order to evaluate and evacuate the cyst fluid. during the eus-fna and just after the cyst fluid aspiration, albumin bound paclitaxel will be injected into the cyst cavity. the study procedure (injection of drug into cyst cavity) takes place over 5 minutes during the eus-fna. 2 days after the procedure you will receive a phone call from the research coordinator to check on how you are feeling. 3 months after study procedure participants will undergo a follow up ct to see what happened to the cyst. you will continue to have routine follow up for your medical problems.

Eligibility criteria:
inclusion criteria: * mucinous cysts (premalignant or malignant cysts of the pancreas) * normal organ and marrow function * baseline ct within 6 months of enrollment exclusion criteria: * pregnant or breastfeeding * acute active pancreatitis * complicated pancreatic cysts * subjects who do not speak english

Keywords: premalignant malignant
effect of lymph node ratio in gastric cancer to determine recurrence rate after curative resection

Conditions: Gastric Cancer

Summary: d2 gastrectomy is standard treatment of early gastric cancer in japan but in other countries there is still some discord, especially in europe and north america. although the quantity of metastasis cancer in lymph node defines survival regardless of which country the patient is treated, the total number of lymph nodes harvested is an important factor to predict accurate staging and/or d2 gastrectomy. both of the number total lymph nodes and the metastasis lymph node status in gastric cancer are important factors to decide each prognosis. this study evaluated the correlation between total lymph nodes retrieved and metastasis node by lymph node ratio (lnr) status to determine the recurrence rate after curative resection of gastric

a retrospective chart review was made of all patients who presented with gastric cancer after curative surgery resection from january 1, 1995 to december 31, 2016 in ramathibodi hospital.data of metastasis node by lymph node ratio (lnr) were evaluated. the total of lymph node less than 15 and more than 15 were evaluated. the kaplan-meier curve estimates recurrence survival (log-rank test). the p-value \< 0.05 is statistically significant. objective : the outcome of this study was evaluated lymph node ratio (lnr) status that determined by the ratio of total lymph node metastasis and the total lymph node which retrieved after performed the curative surgery and lymphadenectomy of gastric cancer. the correlation of lnr and prognosis of recurrence and survival of gastric cancer patients were evaluated and reported in this study.

Eligibility criteria:
inclusion criteria: * gastric cancer after curative surgery resection * no received neoadjuvant therapy * patients have tissues confirmed by pathology * staging used esophagogastroduodenoscopy (egd) or imaging, including ultrasonography, computer tomography (ct) or magnetic resonance imaging (mri * surgery was performed for curative intent and d2 lymphadenectomy and according from japanese guideline for gastric cancer exclusion criteria: * distant metastasis during surgery

Keywords: lymph node metastasis, gastric cancer
codp imaging from a dose perspective

Conditions: Radiation

Summary: the noncontrast-enhanced chest computed tomography (ct) is an emerging diagnostical tool in patient with chronic obstructive pulmonary disease (copd). as shown in previous studies and pointed out by the fleischner society, an additional scan in expiration reflects the pathophysiology of this complex disease better and extends the clinical information of the ct. nevertheless, this scan is leading to an increase in radiation dose. but currently it is unclear if this increased radiation dose is proportional to the additional clinical value when compared to inspiration-only protocols. therefore, the aim of this study was to compare the organ specific radiation doses of a combined inspiration-expiration ct on a 3rd generation dual-source scanner with noncontrast-enhanced chest cts of two clinical routine scanners. therefore, the radiation doses of nearly 2000 chest cts have been evaluated.


Eligibility criteria:
inclusion criteria: * noncontrast-enhanced chest ct performed on one of the named devices * imaging performed between august 2014 and september 2017 * ct protocol used as previously specified exclusion criteria: -

Keywords: copd computed tomography expiration organ specific radiation dose
chronic inflammatory rheumatism: management of comorbidities in ambulatory medicine

Conditions: Chronic Inflammatory Disease

Summary: identification of factors limiting compliance with the recommendations established during the evaluation of the scoric population by the rheumatology department of the chu grenoble alpes

in the rheumatology department of the chu grenoble alpes, professor baillet and other rheumatologists have set up a holistic assessment of inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis) and associated co-morbidities in a day hospital. based on this assessment, a hospital report is drawn up summarising the patient's treatment options, which is then sent to the patient's referring physician. they analysed the first 100 patients in the cohort and showed that 98% of patients were not up to date with their care. their longitudinal analysis shows that patients update two thirds of the recommendations made within 12 to 18 months. therefore, the investigators would like to assess the applicability of this screening in these patients, through a questionnaire sent to the 400 patients of the cohort and to their treating physicians.

Eligibility criteria:
inclusion criteria: * patient cohort : * men and women over 18 years of age * informed volunteers who have consented to participate in the study * have rheumatoid arthritis, spondyloarthritis or psoriatic arthritis * have been hospitalised in a day hospital in the rheumatology department of the grenoble-alpes university = scoric cohort of the department * cohort of referring physicians : * volunteers who received informed information and consented to participate in the study * be the referring physician of a patient of the scoric cohort of the rheumatology department of the south hospital of the chu grenoble-alpes exclusion criteria: * patient cohort : * psychiatric pathologies or history of behavioural disorders * persons referred to in articles l1121-5 to l1121-8 of the public health code * persons under guardianship or curatorship * not affiliated to the social security system * minors * refusal to participate by the patient and/or unreturned questionnaire * cohort of referring physicians: * the physician is no longer the patient's referring physician * refusal of the doctor to participate and/or questionnaire not returned

Keywords: rheumatoid arthritis spondyloarthropathy spondylarthritis ankylosing spondylitis psoriatic arthritis chronic inflammatory rheumatic diseases comorbidities continuity of patient care patient compliance adherence non-adherence
necessity of esophageal dissection during laparoscopic fundoplication

Conditions: Gastroesophageal Reflux Disease; Hiatal Hernia

Summary: this study compares complete dissection of the tissue around the lower esophagus to no dissection of these tissues during laparoscopic fundoplication in children.

this will be a 2-center, prospective randomized clinical trial involving patients who require an operation for gastroesophageal reflux disease. this is intended to be a definitive study. all patients will receive the standard operation for reflux: laparoscopic fundoplication. the dissection will be performed by either separating the phrenoesophageal membrane, or by leaving the phrenoesophageal membrane intact. sample size calculated on a power of 80% with an alpha level of 0.05 using the recurrence rates demonstrated by our retrospective data produce a number of 159 patients in each arm of the study. given that we will need to follow these patients for 1 year after enrollment, there may be some attrition due to lost follow-up. therefore 180 patients per arm would account for just over 10% attrition. one group will undergo laparoscopic fundoplication with complete mobilization of the lower esophagus by circumferentially dividing the phrenoesophageal membrane. the other group will undergo laparoscopic fundoplication without dividing this membrane. the operation, post-operative care, and follow-up plan will otherwise not differ between groups. if 4 consecutive recurrences are found in one group, an interim analysis will be conducted. if a recurrence difference between groups of statistical significance is detected, the study will be concluded at this point. without this occurrence, an interim analysis will be conducted at 180 patients enrolled.

Eligibility criteria:
inclusion criteria: * under 18 years of age * gastroesophageal reflux disease exclusion criteria: 1. hiatal hernia demonstrated on preoperative contrast study, computed tomography or endoscopy 2. prior esophageal operation (e.g. esophageal atresia repair, esophageal myotomy) 3. prior operation for congenital diaphragmatic hernia 4. patient or family circumstance that will create difficulty attaining one-year follow-up (e.g. referral from distance or anticipated relocation of family) 5. patients not considered laparoscopic candidates by the staff surgeon or anesthesiologist (e.g. carbon dioxide retaining lung disease, congenital heart disease, or complex previous abdominal operations)

Keywords: gerd hiatal hernia recurrence
a study comparing a disposable flexible cystoscope with reusable scopes in adult patients.

Conditions: Bladder Cancer; Bladder Stone; Bladder Outlet Obstruction; Renal Stone; Renal Disease

Summary: this study will compare the time required for a cystoscopy procedure in adult participants using the redpine® rflex endo(trademark) high-definition cystoscope or the site's standard of care reusable flexible cystoscope in participants requiring urethral stent removal.

this randomized study will compare the cumulative procedure time between cystoscopy performed with the redpine® rflex endo(trademark) high-definition cystoscope and the site's standard of care reusable flexible cystoscope in adult study participants requiring cystoscopy for visualization of and/or intervention on the urinary bladder. the study will evaluate the user experience and product performance during cystoscopic procedures. participant experience, tolerance to the procedure, and any differences in adverse events between disposable and reusable scope will be evaluated. the hypothesis is that the redpine cystoscope will perform as well as reusable scopes and will have a shorter cumulative procedure time.

Eligibility criteria:
inclusion criteria: 1. male or female, aged at least 18 years old 2. patient undergoing routine flexible cystoscopy 3. no active urinary tract infection 4. subject is willing and able to sign informed consent and hipaa authorization. exclusion criteria: 1. known unpassable urethral stricture 2. febrile patient with active urinary tract infection (uti) 3. subjects with acute infection (acute urethritis, acute prostatitis, acute epididymitis) 4. subject with severe coagulopathy 5. subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control.

Keywords: cystoscopy
study of lm-305 in patients with relapsed or refractory multiple myeloma (rrmm) and other plasma cell diseases

Conditions: Relapsed or Refractory Multiple Myeloma; Other Plasma Cell Diseases

Summary: a phase i/ii study of lm-305 in patients with relapsed or refractory multiple myeloma (rrmm)

a phase i/ii, open-label, multiple centre clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of lm-305 in patients with relapsed or refractory multiple myeloma (rrmm)

Eligibility criteria:
inclusion criteria: subjects will be enrolled into the study only if they meet all of the following inclusion criteria: 1. subjects who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent form (icf) prior to any procedure. 2. aged ≥18 years old when sign the icf, male or female. 3. eastern cooperative oncology group (ecog) performance status of 0-1。 4. life expectancy ≥ 6 months. 5. subjects must show appropriate organ and marrow function in laboratory examinations exclusion criteria: subjects will be excluded from the study, if they meet any of the following criteria: 1. a history of other malignant tumors than multiple myeloma within 3 years prior to first dosing 2. subjects who have severe cardiovascular disease。 3. use of any live attenuated vaccines within 28 da ys prior to 1st dosing of imp. 4. child-bearing potential female who have positive results in pregnancy test or are lactating. 5. subject who is judged as not eligible to participate in this study by the investigator.
safety and efficacy of daclatasvir (bms-790052) plus standard of care (pegylated-interferon alpha-2b and ribavirin) in japanese patients

Conditions: Hepatitis C Infection

Summary: the purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis c virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care


Eligibility criteria:
key inclusion criteria: * patients chronically infected with hepatitis c virus (hcv) genotype 1 * hcv rna viral load ≥10\*5\* iu/ml at screening * naïve or nonresponsive to the current standard of care key exclusion criteria: * cirrhosis * hepatocellular carcinoma * coinfection with hepatitis b virus, hiv-1 or hiv-2