Kornimate/medical-research-clean huggingface dataset:
iron supplementation and intestinal health

Conditions: Anemia of Prematurity; Very Low Birth Weight Infant

Summary: this is a randomized double-blinded study of enteral iron supplementation in very low birth weight infants. the subjects will be randomized into low dose (2 mg/kg/day) and high dose (6 mg/kg/day) of daily iron supplementation. the primary outcomes are intestinal health including microbiome, inflammation, and barrier function.

infants and mothers will be recruited at a single academic level iii nicu at tampa general hospital, tampa, fl. inclusion criteria infants: \<1500 g at birth, expected to live beyond 2 weeks, not yet started on oral iron supplementation (ois), and parental consent. exclusion criteria infants: congenital intestinal defects, history of intestinal infection or perforation before ois. infants who require epogen for religious reason to prevent them from getting blood transfusions will be excluded from the study. intervention: participants will be randomized to either 6 mg/kg/day or 2 mg/kg/day total of elemental iron once a day when they are consuming 150-160 ml/kg/day of enteral feeds and are at least 14 days old. the total iron doses will be provided by fortification of feeds and liquid iron sulfate and will be weight adjusted once a week. the participants will receive the study ois doses until 36 week corrected gestational age or discharge, whichever comes first. sample collection and testing: 1. stool and urine collection: we will collect weekly stool and urine samples non-invasively starting at enrollment until study completion. samples will be collected from soiled diapers. 2. blood tests: we will collect c-reactive protein (crp) and ferritin level at 4 weeks after birth at the same time as other routine labs (complete blood count, reticulocyte count, and liver function test). 3. monaural auditory brainstem response (abr): for each ear will be performed at 36 weeks corrected gestational age or at discharge under the supervision of an audiologist who is blinded to the infants assigned iron doses and test results (stool microbiome, blood and urine tests). monitoring: iron supplementation dose will be increased by 2 mg/kg/day if ferritin level \ 400 mg/dl. ferritin level will be rechecked every 2 weeks until normalized. hematocrit and reticulocyte count will be monitored by the medical team.

Eligibility criteria:
inclusion criteria: * \<1500 g at birth, expected to live beyond 2 weeks, not yet started on oral iron supplementation (ois), with mother at least 18 years of age, and parental consent. exclusion criteria: * congenital intestinal defects, history of intestinal infection or perforation before ois. infants who require epogen for religious reason to prevent them from getting blood transfusions will be excluded from the study.

Keywords: intestinal dysbiosis
prenatal iron supplements: safety and efficacy in tanzania

Conditions: Malaria; Anemia

Summary: the purpose of this study is to determine safety and efficacy of prenatal iron supplementation in an area of high malaria burden among women who are not anemic or iron deficient.

iron deficiency anemia and malaria are urgent public health problems in sub-saharan africa, including tanzania. there is a paucity of good quality randomized trials assessing the safety and efficacy of iron supplementation in pregnancy, and its effects on perinatal health outcomes. prenatal iron supplementation is recommended based on its demonstrated benefit in preventing and treating maternal anemia. there is limited data on the efficacy of iron supplementation on pregnancy outcomes, including birth weight. there are also concerns regarding the use of iron supplementation, particularly among non-anemic women. in particular, there is a lack of research on the safety and efficacy of prenatal iron supplementation in developing regions, characterized by extensive burden of iron deficiency, malaria, and other endemic infectious diseases. evidence from randomized controlled trials is urgently needed to examine the safety and efficacy of iron supplements among pregnant women in malaria endemic regions, particularly among women who are not anemic. note: the time frames listed for the maternal malaria and hemoglobin outcomes were updated on 4/22/15. this record initially indicated that maternal malaria anemia and hemoglobin would be measured at several specific time points throughout the study. instead, maternal malaria was measured throughout pregnancy and hemoglobin was measured only at delivery. due to an oversight, we did not update this record when this protocol change took effect at the start of the study.

Eligibility criteria:
inclusion criteria: * at or before 27 weeks of gestation * primigravida or secundigravidae * not anemic (defined as hb\<8.5 g/dl) * not iron deficient (defined as serum ferritin \<12 μg/l) * hiv-uninfected * intend to stay in dar es salaam until delivery and for at least six weeks thereafter. exclusion criteria: * after 27 weeks gestation * not primigravida or secundigravidae * anemic * iron deficient * hiv-infected * high iron stores at baseline (i.e., serum ferritin \>200 μg/l) * do not intend to stay in dar es salaam until delivery and for at least six weeks thereafter.

Keywords: malaria iron pregnancy anemia birth weight
immunotherapy following reduced intensity conditioning and allogeneic stem cell transplant for poor risk cd30+ hodgkin lymphoma patients

Conditions: Hodgkin Lymphoma

Summary: patients with relapsed or refractory hodgkin lymphoma who are cd30+ will receive a standard of care reduced intensity regimen and an allogeneic stem cell transplant (from another person, related or unrelated). following recovery, patients will receive a medication called brentuximab vendotin which is targeted against cd30+ cells. the study hypothesis is that this treatment will be safe and well tolerated in children and young adults.


Eligibility criteria:
inclusion criteria: * 45 years of age or less. * patients with hodgkin lymphoma with either of the following: • primary induction failure (failure to achieve initial cr) and/or primary refractory disease or first, second or third relapse and history of prior ablative auto hsct or ineligible for an ablative auto hsct or ≥25% residual disease after at least two reinduction chemotherapy cycles and hla matched family donor (6/6 or 5/6) or matched unrelated adult donor (mud) (8/8) or matched umbilical cord blood unit (≥5/6) with prethaw cell dose of at least 3 x 107/kg tnc. * off other investigational therapy for one month prior to entry in this study. * adequate organ function exclusion criteria: * patients with hd with 4th or greater cr, pr, and/or sd are ineligible. * patients with rapidly progressive disease (pd) unresponsive to reinduction chemo, radio, or immunotherapy are ineligible. * patients who don't have an eligible donor are ineligible. * women who are pregnant are ineligible.

Keywords: brentuximab vedotin immunotherapy relapsed hodgkin lymphoma refractory hodgkin lymphoma reduced intensity conditioning allogeneic stem cell transplantation
a study of imc-002 for the treatment of active systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to evaluate the efficacy and safety of imc-002 in the treatment of active sle.

this is a phase ib/ii study, including 2 stage, phase ib study to find the dose for phase ii study between 0.8mg/kg、1.2mg/kg and 1.6mg/kg dose level, phase ii study is a multi-center, randomized, double-blind, placebo control study to evaluate the safety and efficacy of imc-002 in active systemic lupus erythematosus patients.

Eligibility criteria:
inclusion criteria: * has had a diagnosis of sle for at least 12 weeks prior to the screening visit. * sledai total score ≥ 6 at screening * bilag-2004 organ system scores of at least 1 a or 2 b at screening. * currently receiving at least one of the soc sle medications: oral corticosteroid, antimalarial and/or immunosuppressive agent. * other protocol defined inclusion criteria may apply. exclusion criteria: * active or unstable neuropsychiatric sle or lupus nephritis * autoimmune or rheumatic disease other than sle * significant, uncontrolled medical conditions not related to sle * active and/or severe viral, bacterial or fungal infection * history of malignancy within 5 years * other protocol defined exclusion criteria may apply.
radiofrequency ablation for the treatment of gastric dysplasia

Conditions: Gastric Dysplasia; Neoplasia

Summary: the finding of gastric dysplasia not associated with macroscopic lesions (dnaml) or the follow-up of dysplasia after endoscopic resection (daer) is a challenging dilemma. in the last few years, radiofrequency ablation (rfa) has become a recognized tool in the treatment of dysplastic barrett's esophagus, but its use in gastric dysplasia has not yet been studied. the investigators aim to study the efficacy, safety and tolerability of rfa in the treatment of dysplastic gastric mucosa.

gastric cancer is the fourth most common cancer and the second leading cause of cancer related death worldwide. the 10-year survival of patients with this malignancy is 20% due to advanced disease at the time of diagnosis. screening programs in countries with a high incidence of gastric neoplasia aim to detect early stage cancer, suitable for curative treatment. well-differentiated dysplastic gastric lesions limited to the mucosa (when non-ulcerated or ulcerated and less than 3 cm) or limited to the superficial submucosa (when less than 3 cm and with no lymphatic or vascular invasion) have a negligible risk of lymph node metastasis and are suitable for endoscopic curative treatment. endoscopic mucosal resection (emr) and endoscopic submucosal dissection (esd) have been increasingly used in this setting with promising results. however, even with these advanced techniques, en bloc and r0 resection is not possible in up to 13-15% and 16-26% of the cases, respectively. the presence of dysplasia after endoscopic resection (daer) in the post-resection scar presents a challenging dilemma due to the technical difficulty, and associated complications, of performing subsequent emr/esd in fibrotic tissue. another issue of concern is the presence of gastric dysplasia not associated with macroscopic lesions (dnaml). in such cases, a targeted endoscopic treatment is difficult and clinical management is not standardized. radiofrequency ablation (rfa) has been increasingly advocated for the treatment of dysplastic barrett's esophagus (be) and early esophageal squamous cell carcinoma (escc), but its use in gastric dysplasia has not yet been tested. the investigators aim to study the role of gastric rfa in the treatment of dnaml and daer.

Eligibility criteria:
inclusion criteria: 1. histological confirmation of gastric dysplasia. 2. the lesion is no larger than 5 cm in diameter. 3. age ≥ 18 years. 4. subject is able to tolerate endoscopy and sedation. 5. subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form. exclusion criteria: 1. prior gastric irradiation or surgery. 2. anti-platelet or anti-thrombotic medication use that can not be stopped for 7 days before and after rfa. 3. gastric ulcers, fistulae, varices and malignancy. 4. history of alcohol and/or controlled substance dependency. 5. pregnancy.

Keywords: radiofrequency ablation gastric dysplasia gastric neoplasia
telephone physical activity intervention in obese youth

Conditions: Obesity

Summary: the purpose of this study is to examine the effectiveness of a telephone-based physical activity (pa) intervention in obese adolescents attending a health weight comprehensive clinic. secondary aims focus on increasing the amount of change in obesity markers, namely waist circumference and bmi z-scores. the investigators hypothesize the following: 1.the telephone-based pa intervention will increase pa levels above the mail group; and 2. the telephone-based pa intervention will provide changes in waist circumference and bmi z-scores above the mail group.

obesity rates in youth have tripled over the past 20 years. physical activity aids in weight loss and is critical for weight maintenance. further, physical activity has other physiological and psychological benefits. obese youth often see specialists for weight loss treatment. treatment in a pediatric population uses a multi-component approach, but physical activity if often overlooked. combining physical activity information with physician care and nutritional information could improve weight loss and the overall health of these obese children.

Eligibility criteria:
inclusion criteria: * 12 to 18 years old * attending the ecu pediatric comprehensive healthy weight clinic exclusion criteria: * must be able to read and write in english * must be able to participate in physical activity

Keywords: physical activity obesity adolescents telephone bmi body mass index
artificial intelligence (ai)-assisted risk-based prostate cancer detection

Conditions: Prostate Cancer

Summary: this is a prospective clinical study recruiting 510 men at risk of pca to undergo urine, blood, ai-assisted ultrasound and ai-assisted mri investigations to stratify risk of clinically significant pca (cspca). (sample size calculation in section 5)

all recruited patients will undergo investigations including urine for spermine, blood for mirna, trus, and mri prostate. patients with high suspicion of cspca in any one step (urine, blood, ultrasound, or mri) will be offered an image-guided prostate biopsy. this will be followed by machine learning techniques to find the best combination in predicting cspca.

Eligibility criteria:
inclusion criteria: * men ≥18 years of age * clinical suspicion of prostate cancer * serum prostate-specific antigen (psa) 4-20 ng/ml * digital rectal examination ≤ ct2 (organ confined cancer) * able to provide written informed consent exclusion criteria: * prior prostate biopsy * past or current history of prostate cancer * contraindicated to undergo plain mri scan (e.g. pacemaker in-situ, claustrophobia) * contraindicated to transperineal prostate biopsy: active urinary tract infection, fail trus probe insertion or lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped
transcutaneous electrical nerve stimulation after total hip arthroplasty

Conditions: Transcutaneous Electric Nerve Stimulation; Pain

Summary: transcutaneous electrical nerve stimulation (tens) is characterized by the application of an electric pulsed current through electrodes positioned on the skin. it can be an alternative for pain management after surgery for total hip arthroplasty (tha), since it is a safe and cost-effective therapeutic tool, allowing the patient to move early due to pain relief. therefore, the study aims to evaluate the acute effects of tens associated with standard physical therapy compared with standard physical therapy on the intensity of pain, hip range of motion and morphine consumption in the rehabilitation of patients after tha.

the study included patients who underwent tha surgery in the hospital de clínicas de porto alegre (hcpa) and met the study eligibility criteria. the sample was randomly divided into experimental group, which received conventional physical therapy associated with the application of tens, and control group, which held only conventional physical therapy, both on the first day after the surgery. the pain level, the range of motion of the operated hip and the administration of morphine. the experimental group received tens application held by four self-adhesive electrodes size 5x9cm positioned about five centimeters from the edges of the surgical scar. tens was applied in conventional mode, emitting a pulsed biphasic, symmetrical rectangular wave with frequency of 100 hz and pulse duration of 100 µs, for 30 minutes. the intensity was set according to the tolerance of the patient and was gradually increased during the application. the device used was the neurodyn ii model, by ibramed. subsequently, the conventional physical therapy was performed. the patients realized active exercises of plantar flexion and dorsal flexion of the ankles, flexion and extension of the knees and adduction and abduction of the hips, in both lower limbs. all exercises were performed with the patient in the supine position in the bed, in one serie of 10 repetitions. control group received only conventional therapy consisting of the exercises in both lower limbs, identical to those performed in the experimental group.

Eligibility criteria:
inclusion criteria: * patients who underwent tha surgery due to primary or secondary coxarthrosis; both sexes; age between 40 and 90 years. exclusion criteria: * patients who refused to participate of the study; tha indication for fractures and bone tumors; tha review surgery; postoperative infection; congenital anatomical alterations; neurological disorders; lack of understanding of commands; sensitivity alterations in the lower limbs; decompensated heart disease or cardiac pacemaker use.
open versus arthroscopic release for lateral patellar compression syndrome: comparative study

Conditions: Knee Arthroscopy

Summary: chronic anterior knee pain with a stable patella is often associated with overload and increased pressure on the lateral facet due to pathologic lateral soft-tissue restraints. "lateral pressure in flexion" is a term describing the pathologic process of increasing contact pressure over the lateral patellar facet as knee flexion progresses. eighty patients were involved in this study, and it was divided into 2 random groups; group a (40 patients)(odd number) were treated with open release after diagnostic arthroscopy and group b (40 patients)(even number) were treated by arthroscopic release. all these patients are diagnosed as lateral patellar compression syndrome depending on clinical features, mri and diagnostic arthroscopy. all patients were followed by lysholm knee scaling score before surgery and two weeks , six weeks then 6 months after surgery.

this study was done by two orthopedic surgeons working in three hospitals from march 2016 to april 2018, eighty patients were involved in this study, and it was divided into 2 matched groups; group a (40 patients) were treated with open release after diagnostic arthroscopy and group b (40 patients) were treated by arthroscopic release. all these patients are diagnosed as lateral patellar compression syndrome depending on clinical features, mri ( figure 1)and diagnostic arthroscopy. all patients were followed by lysol knee scaling score before surgery , two weeks , six weeks then 6 months after surgery. the two groups are matched related to age and gender. 52 patients are females and age ranged from 21-48 years. exclusion criteria are 1. smoking 2.patellar instability 3. d.m 4. knee osteoarthritis 5. previous knee surgery 6. knee deformities involving varus , valgus or recurvatum 7. ligament laxity

Eligibility criteria:
inclusion criteria: * all these patients are diagnosed as lateral patellar compression syndrome depending on clinical features, mri and diagnostic arthroscopy. exclusion criteria: 1. smoking 2. patellar instability 3. d.m 4. knee osteoarthritis 5. previous knee surgery 6. knee deformities involving varus , valgus or recurvatum 7. ligament laxity

Keywords: lateral patellar compression syndrome arthroscopic release open release
undistort correction of distortions in diffusion mri v1.0

Conditions: MR Image Distortion Correction; Prostate Cancer

Summary: this is a three-year project funded by a cancer research uk multidisciplinary award and brings together a team from ucl division of medicine, computer science and university college london hospital. the aim is to develop magnetic resonance (mr) sequences and mathematical algorithms to reduce the distortions in mr images, especially of the prostate.

this is a three-year project funded by a cancer research uk multidisciplinary award and brings together a team from ucl division of medicine, computer science and university college london hospital. the aim is to develop magnetic resonance (mr) sequences and mathematical algorithms to reduce the distortions in mr images, especially of the prostate. current nice guidelines include a type of mr imaging called diffusion weighted mri for the detection of tumour within the prostate, and for active surveillance of low risk confirmed disease. however, approximately 40% of prostate diffusion images suffer from severe localised distortions and this is most marked in the peripheral zone of the prostate where 75% of prostate cancers occur. the source of these distortions is magnetic field imperfections due to the presence of rectal gas or metallic hip implants. the research study will ask both healthy volunteers and patients to undergo research mr scans and use the acquired data for analysis. for patients, the scans may be either additional sequences acquired during an extended clinical session, or a separate additional session entirely for research. the output from the research will be modified ways to run an mr scanner and compute the final images. the work should lead to improved diagnostic accuracy and a reduced number of non-diagnostic studies. it will have broader impact through application to diffusion imaging of other body sites, including whole-body diffusion mri and non-cancer applications. if successful, the results would provide evidence for a larger trial with the eventual outcome being manufacturers incorporating modified mr sequences and data processing into clinical systems worldwide.

Eligibility criteria:
inclusion criteria: * for the development and testing phases, there are no specific inclusion criteria. assessment of the primary outcome measure (reduced distortions) also does not require specific inclusion criteria. the intended application of our methods is to prostate cancer and this is reflected in some of the secondary outcome measures. recruitment will come from the uclh imaging bookings system. this list will include many men having prostate scans and many of these will subsequently be found to have at least a suspicion of cancer. note there is no requirement for a suspicion of cancer to be recruited for the study. exclusion criteria: * subjects unable to have an mri scan due to contraindications for mri, for example, pacemaker and certain other implants, severe claustrophobia. * subjects unable to give informed consent. * children and vulnerable populations.

Keywords: mri distortion correction magnetic resonance imaging prostheses