Kornimate/medical-research-clean huggingface dataset:
trial of nutritional supplementation in infants born small for gestational age

Conditions: Birth Weight

Summary: the purpose of this study was to determine whether giving a nutrient enriched formula to infants born small-for-gestational age benefits blood pressure, growth and body composition by six months of age.

infants born small for gestational age often show impaired growth during childhood and reduced height as adults. infants who are breast-fed from birth show greater 'catch-up' growth during the first few months of life than those who are formula fed but it is not clear what factors in breast milk (ie protein, nucleotides, lcpufas) are responsible for this 'catch-up' growth. this rct compares the effects of using an enriched formula with increased protein and modified triglyceride (palmitate predominantly in sn-2 position) against a standard infant formula from birth to six months on infants whose birth weights are below the 20th centiles for gestational age. infants are measured by a research midwife within 10 days of birth (at randomisation), 8, 16 and 26 weeks of age. at randomisation consent from the mother is taken and information collected about the pregnancy, social, demographic and medical data. at this and each further visit anthropometric measurements including skinfolds will be collected in addition to blood pressure and bio-electrical impedence at six months. a sub-sample of infants will have their body composition assessed by deuterium labelled water at six months. data on health, weaning diets and bowel function are also collected at each visit.

Eligibility criteria:
inclusion criteria: * infants who are formula fed from birth * infants whose birthweights are less than 20th centile * singleton births * gestation \> 37 weeks * infants free from major congenital disease exclusion criteria: * infants who are breast-fed * multiple births * birthweight \> 20th centile * infants with congenital disease * gestation \< 37 weeks

Keywords: infants whose birthweight is less than the 20th centile for gestational age (uk standards) infants who are formula fed from birth singletons infants free from major congenital disease
the effect of punctal plugs on ocular surface after povidone-iodine preparation of intravitreal injection

Conditions: Dry Eye Syndromes; Dry Eye; Ocular Surface Disease

Summary: the aim of this study is to evaluate the effectiveness of punctal plugs in reducing ocular surface (eye surface) irritation after intravitreal injections prepared by povidone-iodine 5% solution.

intravitreal injection is a shot of medication into the eye. many retinal diseases, such as diabetic retinopathy, neovascular age-related macular degeneration, and retinal vein occlusions require regular, periodic injections. patients often reports eye surface irritation post intravitreal injection. one of the reasons for such discomfort is attributed to povidone-iodine solution used to clean the eye surface to reduce sight-threatening infections. patients who already experience symptoms of dry eye are at increased risk of discomfort after povidone-iodine prepped intravitreal injections. povidone-iodine is known to be corrosive to the corneal epithelium and delay eye surface healing. human tears contain proteins and chemicals that lubricate, heal, and protect the eye surface from infections and irritants. adequate tear film therefore not only dilutes povidone-iodine, but also promotes corneal healing post povidone-iodine prepping. the primary long-term objective of the present study is to investigate whether punctal plugs will reduce eye discomfort post intravitreal injections as reported by the ocular surface disease index (osdi) and other relevant surveys. the secondary outcome is to describe any other risk and protective factors associated with eye surface discomfort after intravitreal injections.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of age-related macula degeneration * clinical diagnosis of diabetic retinopathy * clinical diagnosis of retinal vein occlusion exclusion criteria: * currently wearing punctal plugs * history of punctal cautery, * active ocular infection * history of ocular infection * eyelid trauma * eyelid surgery * graft versus host disease * thyroid eye disease.
real-time optical biopsy in improving lung cancer diagnosis in patients undergoing lung biopsy

Conditions: Lesion; Lung Cancer; Diagnoses Disease

Summary: this pilot early phase i trial studies how well real-time optical biopsy works in improving lung cancer diagnosis in patients undergoing lung biopsy. real-time optical biopsy using confocal microscopy may improve the ability of physicians to diagnose lung cancer and accurately differentiate cancerous and benign lesions found during computed tomography screening.

primary objectives: i. show that it is possible to distinguish lung cancer from benign lesions in ex vivo tissue samples using optical microscopy. ii. test a proof-of-concept endoscopic instrument for imaging through a biopsy needle under computed tomography (ct) guidance on ex vivo tissue samples. outline: patients undergo extraction of up to 3 additional lung biopsies from target lesions that are at least 2-3 cm in diameter using the 19 gauge supercore biopsy needle or the 20 gauge rotax needle. the extracted tissue is imaged via confocal fluorescence microscopy using a variety of fluorescent contrast agents, such as, fluorescein sodium, methylene blue, or indocyanine green and then undergo hematoxylin and eosin processing.

Eligibility criteria:
inclusion criteria: * participants will be drawn from the pool of patients who have suspicious lesions identified on ct and who are already scheduled for a lung biopsy procedure with dr. woodhead or one of his colleagues * patients will be asked to consent to 2 to 3 extra biopsy samples to be used for this research project exclusion criteria: - excluded from this study will be minors below age 18, prisoners, pregnant women, patients with a contraindication for additional lung biopsies, and patients who cannot give informed consent (language barrier, cognitive impairment, etc.)

Keywords: lesion lung cancer diagnosis optical biopsy biopsy
high resolution retinal imaging

Conditions: Stargardts; Retinitis Pigmentosa; Age-related Macular Degeneration; Choroideremia; Geographic Atrophy

Summary: studying the morphology and function of the normal and diseased retina in vivo is needed for advancing the detection, diagnosis, and treatment of retinal disease. this protocol uses an adaptive optics scanning laser ophthalmoscope (aoslo) to image the normal and diseased retina with individual cellular resolution non-invasively. the primary objective of this study is to obtain and analyze high-resolution images of the retina, in particular by imaging the cone photoreceptor mosaic, the retinal vasculature and other retinal layers. the study design will involve case-control studies, where cases are followed over time. subjects age 7 and older may be invited to participate. the main research procedure involves retinal imaging with the aoslo. the primary endpoint is the observation of differences in retinal images between subjects with and without retinal diseases. these changes will be quantified by examining the cell density, size, spacing and regularity of the cone photoreceptor mosaic, as well as examining the differences between other retinal layers.


Eligibility criteria:
inclusion criteria: * males or females age 7 years or older. * parental/guardian permission (informed consent) and if appropriate, child assent. child subjects age 7-17 must give assent. * reasonable compliance with an imaging protocol as determined by the study personnel. exclusion criteria: * individuals that are at risk to acute glaucoma. * individuals that are photophobic and experience adverse psychological reactions to flashes of light. * ocular opacities, high refractive error, and high frequency of nystagmus as determined by the study team.

Keywords: retina imaging retinal degeneration
global real world data in patients with advanced thyroid cancer on standard of care and specialized interventions- registry of oncologic outcomes with testing and treatment.

Conditions: Thyroid Cancer

Summary: the goal of this clinical research study is to learn about the barriers in the real world to accessing treatments for atc. and to learn about how patients with atc tolerate and respond to the commercially available medications for treatment of this disease, outside of a clinical study.

primary objectives: the primary objective of this study is to compare overall survival (os) between atc patients treated at mda versus outside of mda using treatment regimens offered at mda based on braf status and stage of the disease. we will gather prospective real-world, large-scale, comprehensive data on these patients who are unable to access traditional clinical trials but are treated with mda regimens, assigned by stage and braf-status. secondary objectives: 1. to evaluate effect of chemotherapy, immunotherapy, and radiation therapy on the quality of life for atc survivors 2. to evaluate how factors such as health insurance and lack of coverage, adherence, and other sociodemographic characteristics influences patient outcomes.

Eligibility criteria:
inclusion criteria: all adult patients aged 18 years or older with anaplastic thyroid cancer or poorly differentiated thyroid cancer as their clinical and/ or histological diagnosis will be included. exclusion criteria: patients who do not have anaplastic thyroid cancer or poorly differentiated thyroid cancer on their tumor tissue would be excluded.
characteristics of tuberculosis infection in rheumatic disease

Conditions: Tuberculosis; Autoimmune Diseases

Summary: a retrospective study evaluating the characteristics of tuberculosis infection in patients of rheumatic disease.


Eligibility criteria:
inclusion criteria: * the patients with international classification of diseases (icd) codes of rheumatic diseases during 2006-2017 * definite evidence of tuberculosis infection exclusion criteria: * hiv, malignancy, not follow-up rheumatic disease in national taiwan university hospital, younger than 20-year-old, refusing attend research
phenotyping of chronic pain in diffused systemic scleroderma

Conditions: Scleroderma, Systemic; Scleroderma, Diffuse

Summary: the primary objective of the study is to describe the different phenotyping of pain in systemic scleroderma patients and perturbations of mechanisms of the pain. as secondary objectives, the study aims to describe the importances of overall symptoms in alteration of quality of life and conserve the questions which will be associated in a unique questionnaire in order to evaluate the pain, the fatigue and the sleeping disorders in diffused systemic scleroderma patients.

this is a prospective, non-randomized, controlled study. beside the routine care, the patients will have only one visit in the study during which the informed consent will be signed, also the following will be performed: pain evaluation, blood sampling, questionnaires and sudoscan, test qst. 100 patients will be enrolled in total with 50 in each group (scleroderma with pain vs. scleroderma without pain, 1:1 ratio), the duration of inclusion is estimated for 23 months. 2 centers will be involved in the enrollment of patients: rheumatology department and interne medicine department of cochin hospital-aphp. one center will perform the evaluations of pain for all patients: center of pain of cochin hospital - aphp.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years; * patients with diffused ssc according to acr / eular classification 2013 since at least 3 months; * for group pain: pain intensity ≥4 of 11 points of scale (nrs); * for group painless: pain intensity on the month before inclusion. exclusion criteria: * patients unable to understand french language; * patients no-affiliated to the french social security scheme; * patients under the french ame scheme; * patients under guardianship; * pregnant and breastfeeding patients; * patients with thermoalgesic neuropathy; * articular pain from degenerative diseases (known osteoarthritis); * patients under antidepressant; * temporary discontinuation of analgesics which are not well tolerated.

Keywords: scleroderma phenotyping
safety and efficacy of obatoclax mesylate (gx15-070ms) for the treatment of hematological malignancies

Conditions: Hematological Malignancies

Summary: defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogneic signal is present. obatoclax is designed to restore apoptosis through inhibition of the bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.

this is a multi-center, open-label, phase i study of obatoclax administered every 2-week or weekly cycles, or as a prolonged infusion every 2 to 3 weeks to patients with acute myeloid leukemia (aml), myelodysplastic syndrome (mds), chronic myeloid leukemia (cml)in myeloid blast phase, myelofibrosis, previously-treated chronic lymphocytic leukemia (cll), or aplastic anemia. due to the pk/pd sampling schedule cycle 1 will require overnight hospitalization. for the following cycles treatment may be administered on an outpatient basis but is at the discretion of the investigator. no investigational or commercial agents or therapies other than those described within the protocol may be administered with the intent to treat the patient's malignancy. supportive care measures including those directed at controlling symptoms resulting from hematological malignancies are allowed.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmation of aml, mds, cml in blast phase, myelofibrosis, cll, or aplastic anemia * there are no limitations on additional, allowable type and amount of prior therapy as long as acute toxicities have resolved to the allowable grade. * must have normal organ functions * must be willing to submit to blood sampling for the planned pk and pd analyses. * must have the ability to understand and willingness to sign a written informed consent form exclusion criteria: * no other agents or therapies administered for the intent to treat * uncontrolled, intercurrent illness * pregnant women and women who are breast feeding
vyndaqel drug use investigation (regulatory post marketing commitment plan)

Conditions: Transthyretin Familial Amyloid Polyneuropathy

Summary: the purpose of this study is to understand safety (e.g., occurrence of adverse drug reactions \[adrs\]) and efficacy data on the long-term use of vyndaqel capsules (hereinafter referred to as vyndaqel) in all patients who received this drug under actual use conditions after its marketing.

both prospective and retrospective is acceptable all the patients whom an investigator prescribes vyndaqel should be registered

Eligibility criteria:
inclusion criteria: the subjects of this surveillance are all patients who received vyndaqel. exclusion criteria: patients not receive vyndaqel.
oral health promotion program in schools in polígono sur

Conditions: Educational and Preventive Session for Dental Caries; Oral Diseases

Summary: the objective of this observational study is to evaluate oral health before and after conducting an educational session on oral hygiene in schoolchildren from 3 schools in the polígono sur of seville. the main questions it aims to answer are: * to find out the needs of schoolchildren for oral treatment. * to analyse whether the educational sessions carried out serve to improve the oral health of schoolchildren. the researchers will compare the results of different academic years to see if it serves to improve. the participants are examined at the school during the school year. the educational sessions are carried out at the school during the school year.


Eligibility criteria:
inclusion criteria: * schoolchildren whose legal guardians agree to participate exclusion criteria: * schoolchildren whose legal guardians do not consent to participate
a multi-center study of ibrutinib in combination with medi4736 in subjects with relapsed or refractory solid tumors

Conditions: Non-Small Cell Lung Cancer; Breast Cancer; Pancreatic Cancer

Summary: this is a phase 1b/2, multi-center study to assess the safety and efficacy of ibrutinib in combination with durvalumab (medi4736) in participants with relapsed or refractory solid tumors.


Eligibility criteria:
inclusion criteria: 1. pathologically confirmed: non-small cell lung cancer (nsclc, adenocarcinoma or squamous-cell carcinoma), breast cancer (her2 positive or triple negative), pancreatic cancer (adenocarcinoma) 2. relapsed or refractory disease (stage iii or iv): nsclc or pancreatic cancer must have failed at least 1 prior treatment. breast cancer must have failed at least 2 prior treatments. 3. measurable lesion by recist 1.1 4. adequate hematologic function: * anc \>1500 cells/mm3 * platelet count \>100,000 cells/mm3 * hgb \>9.0 g/dl 5. adequate hepatic and renal function: * ast and alt ≤2.5 x uln for subjects without liver metastases and ≤3.5 x uln for subjects with liver metastases * bilirubin ≤1.5 x uln (unless bilirubin rise is due to gilbert's syndrome or of non-hepatic origin) * creatinine ≤2.0 x uln and creatinine clearance ≥40 ml/min (cockcroft-gault or 24-hour creatinine clearance collection) 6. pt/inr \<1.5 x uln and ptt/ aptt \<1.5 x uln exclusion criteria: 1. mixed small cell and nsclc histology 2. a history of cns involvement except as follows: subjects with previously treated cns metastases that are adequately treated with whole brain radiotherapy, that are neurologically stable, and do not require corticosteroids for symptomatic management for at least 14 days prior to first dose of study drug. there must be no clear evidence of radiographically active disease for at least 90 days prior to enrollment. 3. anti-tumor therapy within 21 days of study day 1 4. prior treatment with ibrutinib or other btk inhibitor anti-cd137 or ctla-4 antibody. the following are exceptions to this criterion: subjects previously treated with an anti-pd1, anti-pd-l1, or anti-pd-l2 antibody. 5. history of allogeneic organ transplant 6. treatment with a strong cytochrome p450 (cyp) 3a inhibitor

Keywords: pharmacyclics pcyc ibrutinib durvalumab (medi4736) relapsed refractory solid tumor non-small cell lung cancer nsclc squamous squamous nsclc squamous non-small cell lung cancer immunotherapy imbruvica® tumor immunotherapy anti-pd-l1 lung cancer breast cancer triple negative her2 positive her2 + breast cancer pancreatic cancer
"to study the impact of balloon-occluded retrograde transvenous obliteration (brto)/plug assisted retrograde transvenous obliteration (parto) mediated portal flow modulation in reduction of ammonia and improvement in organ volume and functionality in patients of cirrhosis with lr shunt

Conditions: Liver Cirrhoses

Summary: the informed consent will be obtained from the participants in the study. the study will be conducted on indoor patients, department of hepatology ilbs, new delhi. this will be a pilot study (sample size 25 cases in each arm) with 50% chances of each patient to randomized into each arm(1:1 randomization) . study population - patients with hepatic encephalopathy with lr shunt admitted in wards/hdu (high dependency unit)/lc icu(liver coma icu). study design-randomized controlled trial study period- 1 year. sample size-single centre prospective rct * sample size- pilot study (sample size 25 cases in each arm) * follow up duration-6 months


Eligibility criteria:
inclusion criteria: * child a and b cirrhotic patients with gastro/lieno-renal shunt of \>8 mm. * covert or overt he * age 18 to 70 years exclusion criteria: * intractable ascites * pvt (with 100 % block )or pv cavernoma and splenic vein thrombosis * high risk esophageal varices (till eradicated) * hvpg \>16 mm hg * hcc * pregnancy and lactation * refusal to participate in the study
a lay-led intervention for war and refugee related trauma

Conditions: PTSD

Summary: this study will examine the initial efficacy and feasibility of a program called islamic trauma healing by conducting a small rct (n = 60) comparing islamic trauma healing in an u.s. somali refugee sample to a waitlist control on key targets of ptsd, depression, somatic symptoms, and quality of life. the hypothesis is that those in islamic trauma healing will show a greater reduction of ptsd symptoms, depressive symptoms, and somatic symptoms and show a greater improvement in quality of well-being than those in the waitlist condition (wl).

islamic trauma healing is a lay-led, small-group intervention specifically targeting healing mental wounds of trauma within mosques. the six-session intervention combines empirically supported exposure-based and cognitive restructuring techniques with islamic principles. a lay-led, group program promotes community building, acknowledges trauma's impact in the community, and facilitates wider implementation. the program is not referred to as "therapy" or "treatment" for "mental illness." it incorporates community building (e.g., shared tea, supplication), integrated islamic principles that utilize cognitive restructuring through discussion of prophet narratives (e.g., faith during hard times, prophet job \[ayyub\]), and exposure therapy through individual prayer, talking to allah about the trauma. ultimately, the program will follow a self-sustaining train-the-trainer model, led by group leaders, empowering lay leaders to facilitate healing in their communities. further, training time is dramatically reduced to two, 4-hour training sessions, focusing on teaching skills of group discussion leading rather than training as a lay therapist or mental health counselor. preliminary data from a community sample and from initial men's and women's groups show a strong perceived need and match with the islamic faith, with large effects obtained for pre- to post-group across measures (g = 0.76-3.22). qualitative analysis identified the intervention as operating on potential mechanisms of connectedness to the community, faith integration, healing, and growth. the preliminary data point to the program being well-received and offering a promising model for delivery of a trauma-focused intervention to muslim communities. the next steps are examining islamic trauma healing in a rct, further isolating mechanisms of change, and ascertaining feasibility for wider dissemination studies.

Eligibility criteria:
inclusion criteria: * experienced a dsm-5 trauma at least 12 weeks ago * report current re-experiencing or avoidance symptoms * somali background * islamic faith * 18-65 year of age exclusion criteria: * immediate suicide risk, with intent or plan * cannot understand consent/visible cognitive impairment

Keywords: refugee