Kornimate/medical-research-clean huggingface dataset:
dietary arachidonic acid, obesity and atopic respiratory disease

Conditions: Allergy; Obesity

Summary: epidemiological studies have shown obesity to be a risk factor of asthma. research evidence of obesity and atopic(ie. allergic)-related respiratory diseases, has been less clear. the purpose of the present study was to test the hypothesis that the relationship between obesity and atopic-related respiratory disease in premenopausal women is mediated by a dietary imbalance of omega 6 and 3 polyunsaturated fatty acids.

sixty young adult obese and non obese women, with, and without asthma, were studied using a cross-sectional design. body composition was measured by plethysmography. a fasted blood sample was taken to measure: specific and total immunoglobulin (ige) antibodies,biochemical markers of atopy; glucose and insulin to measure insulin sensitivity; estrogen(17β-estradiol) and sex hormone-binding globulin to measure estrogen status of the women; hormone-products of fat tissue ( leptin, adiponectin, resistin, tumor necrosis factor alpha (tnfα), interleukins (il-6,il-18), that have been associated with both obesity and immune processes involved in asthma and allergy. dietary intake of omega 6: linoleic acid (la), arachidonic acid(aa); and omega 3 fatty acids: α linolenic (ala), eicosapentanoic (epa) and docosahexanoic (dha) and other nutrients were assessed by food frequency questionnaire.

Eligibility criteria:
inclusion criteria: * for asthmatics, only individuals that were willing and capable of not using asthma medications for two days prior to laboratory testing. exclusion criteria: * an individual was excluded from the study if she had a history of high blood pressure, diabetes, heart disease, cigarette smoking, or eating disorders. * women that were pregnant or lactating.

Keywords: arachidonic aci adiposity atopy
efficacy of leg casts with heel off-loaded in children

Conditions: Orthopedic Disorders

Summary: assess whether by placing a "custom made" splint with heel in the immediate postoperative period until removal of the cast, the rate of pain, the number of healthcare interventions to maintain the off-loaded heel position and number of pressure sores in children wearing lower limb plaster casts is reduced.


Eligibility criteria:
inclusion criteria: * treated by operations to the lower limbs which require immediate plaster casts that include the foot * treated by osteotomy, joint fusion, patella repositioning and fracture fixation * children with intact skin at the heel exclusion criteria: * caregivers who cannot speak italian * those who refuse to give their consent to take part in the study * patients with lower limb casts that are allowed to load the limb
the role of standardized training in the diagnosis of interstitial lung disease by transbronchial lung cryobiopsy

Conditions: Transbronchial Lung Cryobiopsy

Summary: the aim of this study was to conduct a prospective randomized controlled trial to design simulator and in vitro lung standardized training, to perform a learning curve evaluation of transbronchial lung cryobiopsy (tblc) operating physicians, and to assess the role of standardized training in tblc.


Eligibility criteria:
inclusion criteria: * age ≥18 years * suspected ild. * ≤3 months since hrct * forced vital capacity (fvc) ≥50% of predicted value * diffused lung carbon monoxide (dlco) ≥35% predicted value * echocardiography ≤ 12 months * estimated pulmonary artery systolic pressure ≤40 mmhg * body mass index (bmi) ≤35 kg/m2 * patient consent for experimentation exclusion criteria: * patients with platelet counts less than 50 × 109/l or prothrombin time international normalized ratio (inr) higher than 1.5 * patients refused to participate in the experiment

Keywords: transbronchial lung cryobiopsy standardized training learning curve bronchoscopist
long-term persistence of hepatitis b and pertussis antibody responses in healthy 4 to 5 year old children previously vaccinated with vaxelis® or infanrix® hexa (v419-012)

Conditions: Hepatitis B; Pertussis

Summary: this is a multicenter extension study of two european randomized, double-blind studies (v419-007 and v419-008). it describes long-term persistence of hepatitis b and pertussis antibody responses in healthy 4- to 5 year old children previously vaccinated with vaxelis® or infanrix® hexa


Eligibility criteria:
inclusion criteria 1. healthy child of either gender, who has received a complete 3-dose primary series or a complete 2 dose primary series followed by a toddler dose with vaxelis or infanrix hexa as part of the v419-007 or v419-008 study respectively. 2. informed consent signed by the participant's parent(s) or legal representative. exclusion criteria: 1. participant who has received any dose of hepatitis b (hb)-containing vaccine at any time other than study vaccine in v419-007 or v419-008 study. 2. participant with a history of diagnosis (clinical, serological or microbiological) of hb virus infection of the v419-007 or v419-008 study. 3. participant who has received any dose of pertussis-containing vaccine after completion of the v419-008 study. 4. participant with a history of diagnosis (clinical, serological or microbiological) of infection due to pertussis after completion of v419-008 study. 5. participation at the time of study enrolment or in the 4 weeks preceding the study enrolment in another clinical study investigating a vaccine, drug medical device, or medical procedure\*. 6. participant who received immunoglobulins, blood or blood-derived products within 3 months prior to inclusion\*. 7. receipt of immunosuppressive therapy or other immune-modifying drugs, such as anti-cancer chemotherapy or radiation therapy since completion of v419-007 or v419-008 studies. 8. participant with suspected or known blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopietic and lymphatic systems since completion of v419-007 or v419-008 studies. * criteria 5 and 6 are temporary exclusion criteria. if a participant meets criteria 5 and/or 6 at the time of visit 1, a further appointment is to be scheduled to reassess the participant's eligibility.

Keywords: immune response
timing of start of systemic treatment for asymptomatic metastasized pancreatic cancer

Conditions: Metastatic Pancreas Cancer

Summary: since patients with metastatic pancreatic cancer have a limited life expectancy, it is important to determine the timing of when to start chemotherapy in order to optimize the benefits of chemotherapy relative to the side effects. therefore, two treatment strategies can be considered: chemotherapy started immediately at diagnosis, or delayed until disease-related symptoms occur.


Eligibility criteria:
inclusion criteria: * signed, written institutional review board/ethics committee-approved informed consent form (icf). * patients with histologically/cytological confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma. * measurable disease on computed tomography (ct) scan per recist version 1.1 criteria. * eastern cooperative oncology group performance status of 0-1 * life expectancy ≥ 3 months. * age ≥ 18 years. * a negative urine or serum pregnancy test within 7 days before day 1 (first dose of study medication) if female subject is of childbearing potential. * screening clinical laboratory values as follows: 1. absolute neutrophil count \> 1.5 x 109 /l 2. total bilirubin ≤ 1.5 times upper limit of normal (uln). 3. aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times uln, (if liver metastases are present, then ≤ 5 times uln is allowed). 4. serum creatinine \ 50 ml/min/1.73 m2 5. prothrombin time/international normalized ratio within normal limits (± 15%) or within therapeutic range if subject takes warfarin. partial thromboplastin time (ptt) within normal limits (± 15%). 6. platelet count \> 100,000 x 109 /l * no symptoms related to advanced disease, specified as: 1. no pain requiring regular narcotic analgesics; 2. no weight loss over 5 kg (unless related to surgery or other illness); 3. no persistent nausea requiring medication; 4. no obstructive bowel symptoms; 5. no persistent fever related to metastatic cancer; 6. no other symptom which in the opinion of the clinician was due to progressive metastatic cancer. * no prior chemotherapy for metastatic disease (patients might have received adjuvant treatment more than 6 months before the development of metastatic disease, or neoadjuvant treatment before surgery for resectable disease) exclusion criteria: * known central nervous system involvement or brain metastases. * new york heart association class iii or iv cardiac disease or myocardial infarction within the past 12 months * any other disease, active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy, metabolic dysfunction, physical examination finding or clinical laboratory finding that leads to reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that may render the subject at high risk for treatment complications. * inability to comply with study and follow-up procedures as judged by the investigator. * women currently pregnant or breastfeeding.
[11c]5-hydroxy-tryptophan pet for assessment of islet mass in type 2 diabetes

Conditions: Type2 Diabetes

Summary: cross-sectional study to investigate subjects at different stages of type 2 diabetes development with expected stratification of pancreatic islet mass. non-diabetic individuals were assigned as control. the primary outcome was the \[11c\]5-hydroxy-tryptophan uptake and retention in the pancreas as a surrogate marker for the endogenous islet mass.


Eligibility criteria:
inclusion criteria: * type 2 diabetes fulfilling criteria for the four different study groups, or healthy volunteers exclusion criteria: * ongoing pregnancy * renal failure (gfr\<60 ml/min) * magnetic metal parts in the body * ongoing treatment with selective serotonin receptor inhibitors
treatment of patients with idiopathic membranous nephropathy

Conditions: Glomerulonephritis, Membranous

Summary: patients with idiopathic membranous nephropathy at risk for renal failure can be identified in an early stage by measuring urinary low molecular weight proteins and urinary immunoglobulin g (igg). this study evaluates the possible benefit of early start of immunosuppressive therapy in these high-risk patients.

inclusion criteria: * patients with idiopathic membranous nephropathy * nephrotic syndrome * normal renal function (serum creatinine \[screat\] \< 1.5 mg/dl) * elevated urinary beta2-microglobulin and igg immunosuppressive therapy consisting of: * cyclophosphamide 1.5 mg/kg/day for 12 months * prednisone orally, 0.5 mg/kg on alternate days for 6 months * i.v. methylprednisolone 1000 mg on days 1,2,3, 60,61,62, 120,121,122 study groups: * early: immediate start of immunosuppressive therapy at the time patient is identified as high-risk * late: start of therapy after deterioration of renal function (increase of screat \> 25% and screat \> 1.5 mg/dl) main outcome parameters: * serum creatinine * remission of proteinuria * period of nephrotic proteinuria * major side effects: hospitalisations, infections

Eligibility criteria:
inclusion criteria: * idiopathic membranous nephropathy * serum creatinine \< 1.5 mg/dl * nephrotic syndrome exclusion criteria: * infection * instable angina * systemic disease * pregnancy * renal vein thrombosis * prior therapy with immunosuppressant agents * liver dysfunction * use of nonsteroidal anti-inflammatory drugs (nsaids)

Keywords: membranous nephropathy cyclophosphamide prednisone
evaluation of lofexidine for treatment of opioid withdrawal - 3

Conditions: Opioid-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to determine the safety of lofexidine in the treatment of opiate withdrawal. preliminary data will also be obtained to assess the ability of lofexidine to alleviate opiate withdrawal signs and symptoms.


Eligibility criteria:
please contact site for information.

Keywords: opiate dependence
fluorescence-guided resection in breast cancer

Conditions: Breast Tumour

Summary: this is an explorative phase ii study to investigate the suitability of pd l 506 in the specific intra-operative detection of breast tumour tissue.


Eligibility criteria:
inclusion criteria: * written informed consent * caucasian female postmenopausal patients * patients with histologically confirmed primary palpable and nonpalpable breast cancer sized up to 5 cm (t1 - t2) exclusion criteria: * suspicious lymphogenic metastases (cn1-3) * acute or chronic hepatic diseases * manifest renal diseases with renal dysfunction * relevant cardiac disease * preceding therapy of breast tumour under investigation * patients with multiple attempts of hook-wire placement in preparation of surgery * dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent * simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment
isoniazid dosage prediction model development

Conditions: NAT2 Genotype

Summary: isoniazid (inh) is an essential component of first-line anti-tuberculosis (tb) treatment. however, treatment with inh is complicated by polymorphisms in the expression of the enzyme system primarily responsible for its elimination, n-acetyltransferase 2 (nat2), and its associated hepatotoxicity. the objective of this study was to develop an individualized inh dosing regimen using a pharmacogenetic-driven model and to apply this regimen in a pilot study.


Eligibility criteria:
* eligible participants were patients newly diagnosed with active tb * who underwent standard four drug treatment for 6months: isoniazid (5 mg/kg, usually 300 mg), rifampin (450 mg for \<50 kg or 600 mg for 50 kg body weight), ethambutol(15mg/kg), and pyrazinamide (20 - 30 mg/kg) * given daily for two months and followed by isoniazid and rifampin with or without ethambutol for four months. * those patients with abnormal hepatic function on laboratory testing (increased serum aspartate aminotransferase, alanine aminotransferase, or total bilirubin) before anti-tb treatment, underlying liver disease or systemic illness such as congestive heart failure, acute life-threatening disease, or alcoholism, or disease that was resistant to inh at the start of treatment were excluded.

Keywords: nat2 genotype guided dosing
preventing disordered eating and body dissatisfaction among high-risk pregnant individuals

Conditions: Eating Disorders; Body Dissatisfaction

Summary: the investigators aim to conduct a feasibility randomized controlled trial (rct) of an eating disorder prevention program (the body project, adapted for pregnancy) versus a health education control among pregnant individuals with histories of an ed. the investigators will test the feasibility, implementation outcomes, and its preliminary effectiveness in reducing the risk of elevated disordered eating and body dissatisfaction during pregnancy and postpartum.

the investigators aim to conduct a feasibility randomized controlled trial (rct) of an eating disorder prevention program (the body project, adapted for pregnancy) versus a health education control among pregnant individuals with histories of an ed. the investigators will test the feasibility, implementation outcomes, and its preliminary effectiveness in reducing the risk of elevated disordered eating and body dissatisfaction during pregnancy and postpartum. the investigators will aim to recruit n=60 pregnant individuals (in their first or second trimester) with histories of an ed. both the intervention and active control consist of 6, weekly, 1-hour group sessions (6-8 participants per group) delivered over zoom. there are four assessment points: pre-intervention, post-intervention, 3 months postpartum, and 6 months postpartum. participants will complete online surveys at each assessment point and a post-intervention exit interview (active intervention only).

Eligibility criteria:
inclusion criteria: 1. within the first or second trimester of pregnancy at enrollment 2. 18 years or older 3. able to provide informed consent 4. endorse a self-reported history of an eating disorder or disordered eating behaviors 5. are willing and able to comply with all group and study procedures 6. english fluency and literacy exclusion criteria: 1. a diagnosis of bipolar or psychotic disorder, active mania or psychosis or substance abuse, an active eating disorder (active eating disorder symptomology informed by the screening, brief intervention, and referral to treatment for eating disorders (sbirt-ed) tool and clinician discretion), being at immediate risk of self-harm 2. do not have access to a device with a camera

Keywords: eating disorder body dissatisfaction body image pregnancy
the predictive value of amniotic fluid ph and electrolytes on neonatal respiratory disorders

Conditions: Respiratory Distress Syndrome; Transient Tachypnea of Newborn

Summary: amniotic fluid (af) is a complex structure with a changing content by gestational time. af ph can be affected by both maternal and fetal conditions such as preterm ruptures of membranes, prematurity and fetal distress. while fetal urine is the major content of af since 20th gestational week, fetal lung liquid (fll) also acts as a minor content. secretion of fll depends on chloride transport and postnatal clearance of fll is provided by active reabsorption of sodium (na) ions. down-regulation of epithelial na channels (enacs) and an increase of pulmonary compliance accompany to pulmonary adaptation developing at the first hours of life. lower genomic expression of na channels in airways is shown to be associated to respiratory distress syndrome (rds) in preterm. although ph and electrolyte value of af is thought to be relevant to fetal and maternal conditions such as gestational age, antenatal steroids and preterm birth, there is no study about this topic in the literature.


Eligibility criteria:
inclusion criteria: accepted to participate with informed consent normal healthy pregnancies exclusion criteria: congenital abnormalities chromosomal abnormalities blood contaminated af declined to participate
optimizing strategies to improve std partner services

Conditions: Chlamydia Trachomatis; Neisseria Gonorrhoeae

Summary: this research tests the effectiveness of a social cognitive intervention (with option of patient-delivered medication) geared toward increasing patient referral of partners.

this is a four-year study involving longitudinal data collection for 800 men and women recruited from four clinics in brooklyn, ny. participants were eligible for enrollment at any of the study sites if diagnosed as having c trachomatis or n gonorrhoeae genital infection or if they have an std syndrome likely to be related to either of these pathogens (i.e., males with ngu). consenting patients were randomly assigned to receive either standard-of-care patient referral for partner notification (n = 350), a social-cognitive intervention geared toward increasing patient referral (n = 350), or the social-cognitive intervention with an option of patient-delivered medication (n = 100). evaluation activities include an interviewer administered measure provided at baseline, one month, and six months, a screen for n gonorrhoeae and c trachomatis using urine-based ligase chain reaction screening (abbott lcx) at baseline and six months, and medical chart abstraction at one and six months.

Eligibility criteria:
inclusion criteria: * any individual presenting at study sites with std-related symptoms who receives a microbiologic diagnosis with n gonorrhoeae and/or c trachomatis will be eligible for study participation if they meet the following criteria: 1) are 18 years of age or older; 2) have been sexually active in the previous two months; 3) are able to understand english or spanish; 4) have resided within the catchment area for at least one year prior to enrollment; 5) plan to remain in the area through the course of the study period. . exclusion criteria: * any potential participant deemed by a provider or member of the study staff to have psychological impairment, brought on by drug use or some other illness, to an extent that it would affect the ability to understand or provide informed consent.

Keywords: partner referral social cognitive intervention partner delivered medication
integrating telehealth to advance lung cancer screening

Conditions: Early Detection of Cancer; Telemedicine; Decision Making

Summary: the goal of this pragmatic trial is to learn if telehealth strategies can increase shared decision-making (sdm) for lung cancer screening (lcs). it will also learn about the equity of these strategies by conducting non-inferiority analysis by race and sex. the main questions it aims to answer are: 1. does patient outreach using synchronous and asynchronous telehealth strategies increase completion of sdm visits for lcs? 2. is the effectiveness of these telehealth strategies similar by race and sex? the study uses a sequential multiple assignment randomized trial (smart) design and includes two stages of interventions. the first stage of intervention includes direct patient outreach with an invitation to schedule either a 1) telehealth sdm visit or 2) telehealth or in-person sdm visit. participants that do not respond to the first stage interventions receive a text message reminder encouraging sdm visit completion with or without digital care coordination.

annual lung cancer screening using low-dose computed tomography (ldct) is associated with decreased lung cancer mortality but also with harms. as such, it is recommended, and required for reimbursement, that patients complete an shared decision-making visit (sdm) prior to screening to discuss potential risks and benefits in the context of patient values. despite guidelines recommending screening and national insurance coverage of ldct, uptake of sdm visits and subsequent ldct is remarkably low. we aim to address these gaps by comparing the effectiveness of synchronous and asynchronous telehealth strategies on sdm visits and subsequent ldct in a pragmatic trial using a sequential multiple assignment randomized trial (smart) design. the specific first stage strategies to be tested are: a) active choice outreach (invitation to schedule a telehealth or in-person sdm visit) vs b) telehealth only outreach (invitation to schedule a telehealth sdm visit). the specific second stage strategies (delivered only if participants do not respond to first stage interventions) are a) text message reminders encouraging sdm visit completion (low-touch) alone or b) in combination with phone-based digital care coordination (high-touch). we will also assess non-inferiority of strategies by race and sex to assess equity of effectiveness.

Eligibility criteria:
inclusion criteria: participants will be eligible if: 1. are aged 50 to 80 2. have a history of tobacco use indicated by either: documented 20 pack-year or greater smoking history in their electronic health record (ehr); or self-report via structured survey 3. currently smoke or formerly smoked cigarettes 4. have no documented history of lung cancer 5. have no documented history of lung cancer screening in the 24 months prior to study enrollment 6. have completed at least one primary care visit at penn medicine in the 3 years prior to study enrollment. exclusion criteria: participants who do not meet inclusion criteria will not be eligible.