Kornimate/medical-research-clean huggingface dataset:
vsl#3 versus placebo in increasing the pathological major response rate in patients with rectal cancer

Conditions: Rectal Cancer

Summary: this is a randomized, double-blind, placebo-controlled phase iii study involving 160 patients designed to assess the efficacy of the high potency probiotic preparation vsl#3® versus placebo in increasing the pathological major response rate in patients undergoing concurrent ct and pelvic rt.


Eligibility criteria:
inclusion criteria: * age \> 18 years * ability to sign informed consent and understand the nature of a placebo- controlled trial. * ability to complete questionnaire(s) by themselves or with assistance. * life expectancy ≥ 6 months. * current diagnosis of cancer that supports the use of continuous definitive or adjuvant external-beam rt to the pelvis to a minimum dose of 4500 cgy delivered with conventional multi-field photon radiotherapy, 3-d conformal photon radiotherapy or intensity modulated photon therapy. * will receive concurrent administration of chemotherapy (5-fu, capecitabine, cisplatin, oxaliplatin, carboplatin, and/or mitomycin) during pelvic rt * the following laboratory values obtained \> 28 days prior to registration: hemoglobin \> 10.0 g/dl wbc \> 3,500 absolute neutrophil count \> 1,500 platelets \> 100,000 * ecog performance status (ps) of 0, 1 or 2 * willing to abstain from ingestion of yogurt products and/or any product containing probiotics during study drug treatment. exclusion criteria: * current or prior metastases beyond regional lymph nodes. * undergone abdominal-perineal resection, hartmann procedure, or other surgical procedure leaving the patient without a functioning rectum. * known allergy to a probiotic preparation. * any history of inflammatory bowel disease. -\> grade 3 diarrhea, rectal bleeding, abdominal cramping, or incontinence of stool, ≤7 days prior to registration. * any medical condition that may interfere with ability to receive protocol treatment. * planned use of leucovorin (because of the risk of secretory diarrhea). * split-course rt is planned. * prior pelvic rt. * proton rt. * any of the following: pregnant women nursing women men or women of childbearing potential who are unwilling to employ adequate contraception * use of probiotics ≤ 2 weeks prior to registration. * use of antibiotics ≤ 1 week prior to registration. * planned continuous antibiotic treatment during rt. * history of gastrointestinal or genitourinary obstruction or porphyria.
intervention to improve the adherence in community pharmacies

Conditions: Chronic Obstructive Pulmonary Disease (COPD; Arterial Hypertension; Diabetes Mellitus

Summary: the anm is the first initiative that puts advanced pharmaceutical care into practice in andalusia (spain). the aim of this is study is to evaluate the effectiveness of the intervention assistance to new medicines (anm) in the improvement of adherence to treatment in community pharmacies.

design: parallel cluster pragmatic randomized controlled trial. the study includes patients users of a community pharmacies, who meet the following inclusion criteria: patient who starts treatment of any of the following pathologies: chronic obstructive pulmonary disease (copd), arterial hypertension or diabetes mellitus in andalusia (spain). in order to avoid possible contamination between patients assigned to the control and intervention group, randomization will be carried out at the pharmacy level; preventing the pharmacist from applying part of the intervention to the control group. interventions: patients randomized: (i) current practice; or (ii) anm intervention thru a pharmacist delivered support for a newly prescribed medicine.

Eligibility criteria:
inclusion criteria: patient who starts treatment of any of the following diseases: * chronic obstructive pulmonary disease (copd). * arterial hypertension * diabetes mellitus. * anticoagulants exclusion criteria: * those users who do not know how to read and write in spanish, * suffer from a physical or mental disorder that makes it impossible to perform the
safety, tolerability and efficacy of bfh772 in rosacea patients

Conditions: Erythemato-telangiectatic Rosacea

Summary: this study will evaluate the safety, tolerability and efficacy of bfh772 after 12 weeks of treatment as compared to an active control and vehicle in patients with erythemato-telangiectatic rosacea.


Eligibility criteria:
inclusion criteria: * have persistent facial erythema on the cheeks of at least moderate severity. * women must not be able to bear children exclusion criteria: * have more than 12 inflammatory lesions on the face * previous treatment of facial skin with lasers or electrocauterisation within 2 months prior to entering the study * have facial hair that makes it difficult to evaluate rosacea on the face other protocol-defined inclusion/exclusion criteria may apply

Keywords: bfh772 rosacea erythemato-telangiectatic rosacea
polygenic risk-based detection of subclinical coronary atherosclerosis and intervention with statin and colchicine

Conditions: Coronary Artery Disease

Summary: the goal of this double-blind randomized controlled trial is to determine how treatment with high intensity statin, low-dose colchicine, and their combination modulates progression and composition of coronary atherosclerosis in individuals with high polygenic risk for coronary artery disease.

the main question proact 2 aims to answer is whether and how single or dual targeting of cholesterol-lowering and inflammation modulates coronary plaque in individuals with high polygenic risk and subclinical coronary atherosclerosis. this is a double-blind randomized controlled trial of 200 individuals with high polygenic risk for coronary artery disease and subclinical plaque on coronary computed tomography angiography. participants will be randomized into four equal treatment groups: group a receiving a placebo daily, group b receiving rosuvastatin 20mg daily, group c receiving colchicine 0.6mg daily, and group d receiving both rosuvastatin 20mg daily and colchicine 0.6mg daily. the primary outcome is change in total non-calcified plaque volume on coronary computed tomography angiography from baseline to one year. multiple secondary plaque imaging and biomarker outcomes will be explored in this pilot mechanistic trial.

Eligibility criteria:
inclusion criteria: * males and females between 40 and 75 years of age capable and willing to provide informed consent * participant has high cad prs as defined on a clinical test * participant with subclinical atherosclerosis defined as plaque visible on ccta and causing \<70% luminal stenosis exclusion criteria: * participant with a history of cardiovascular disease, defined by a diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease * participant with a history of liver disease (cirrhosis, active hepatitis, or severe hepatic disease) or any of the following recent lab results and determined to be non-transient: alanine aminotransferase greater than 3 times the upper limit of normal or total bilirubin greater than 2 times the upper limit of normal (unless due to gilbert syndrome) * participant with estimated glomerular filtration rate \<60 ml/min/1.73 m2 or creatinine greater than 2 times the upper limit of normal * patient with history of an allergic reaction or significant sensitivity to iodinated contrast, colchicine, or statins * patient currently taking ldl cholesterol lowering or anti- inflammatory medications including colchicine * participants requiring regular drugs known to be potent cy2p inhibitors (eg. ketoconazole, clarithromycin) * female patient who is pregnant, or breast-feeding or is considering becoming pregnant during the study * participant with bmi ≥ 40 kg/m2 * participant unable to provide informed consent * participant unable to hold breath for 10 seconds

Keywords: polygenic risk atherosclerosis genetics genomic medicine polygenic score precision medicine preventive cardiology coronary plaque inflammation cholesterol lipids colchicine statin
impact of introducing basaglar insulin to the treatment regimen of youth with diabetes in pakistan

Conditions: Type 1 Diabetes

Summary: this study aimed to determine the effect of introducing basaglar and insulin pen injection devices on clinical and quality of life (qol) parameters in children and young adults with type 1 diabetes in pakistan

analog insulins are widely used in middle- and high-income countries. however, use of analog insulin remains limited in lower-income countries due to their increased cost and lack of access, and human insulin remains the mainstay of treatment in these settings. long-acting (basal) analog insulin such as glargine have the benefit of a longer duration (up to 24 hours) and a minimal peak action, and generally, only one injection per day is required. although glargine insulin has been shown to reduce the risk of overnight hypoglycemia, consistent improvement in blood glucose control (measured by hba1c) when compared to human insulin has not been shown, and its impact on quality of life is also inconclusive. furthermore, these studies have all been done in highly resourced countries. life for a child (lfac) provides diabetes supplies (insulin, syringes, meters and strips for blood glucose self-monitoring), diabetes-related education, mentoring and technical support to the team managing youth with type 1 diabetes (t1d) managed at baqai institute of diabetology and endocrinology (bide) in karachi, pakistan. in 2022, lfac commenced supplying basaglar (glargine) insulin with insulin pen devices (humapen ergo ll). this provided a unique opportunity to investigate the effect of introducing glargine (basaglar) insulin in the low resource setting of pakistan.

Eligibility criteria:
inclusion criteria: * diagnosed with type 1 diabetes according to a combination of clinical (polyuria, polydipsia, and weight loss) and biochemical characteristics (high blood glucose levels (fasting glucose ≥ 126 mg/dl or random glucose ≥ 200 mg/dl) and/or c-peptide levels indicating low insulin production, along with the presence of islet autoantibodies (e.g., gad65, ia-2)) * duration of t1d ≥ 12 months at time of enrolment * willing to conduct self-monitoring of blood glucose (smbg) at least twice daily * no prior use of analog insulin (either long-acting or short-acting) * attending bide for their routine diabetes care and management * no history of other significant medical conditions (e.g., severe renal disease or other autoimmune conditions) * willing to adhere to the study protocol, including attending follow-up visits and participating in the required education sessions exclusion criteria: * prior use of analog insulin * other medical conditions that would interfere with study participation

Keywords: analog insulin basaglar pakistan children and adolescents type 1 diabetes insulin pen-devices
benefits of coding training on young adults with developmental disabilities

Conditions: Developmental Disability

Summary: the purpose of the present study is to develop and evaluate the technology early career preparation intervention (tech-prep) program with african american high school students with developmental disabilities. developmental disabilities include conditions such as autism spectrum disorders, seizure disorders, behavior disorders, brain injury, cerebral palsy, down syndrome, and fetal alcohol syndrome/effects. this program is designed to increase technology career interests, self-efficacy, outcome expectancy, goal persistence, and increase entrance into post-secondary education or work subsequent to high school completion of african american youth with developmental disabilities.

the investigator's goal is to recruit 30 african american high school students with developmental disabilities to participate in this tech-prep study each year for the next five years (2019-2024). the tech-prep program integrates many empirically supported strategies identified in the stem education and the secondary transition research literature. the program will incorporate overview of coding careers, reviewing video testimonials of individuals working in technology fields, and reviewing/responding to training materials intended to facilitate workplace social skills development. the program will require participants complete three surveys to track their progress. to receive incentives for completing program components, data on program component completion will be tracked of participants in the treatment group. this involves tracking data on when a participant completes review of the final segment of each learning module. data collection for this study will consist of three surveys completed at baseline, immediately after completion of the program, and six weeks after completion of the program.

Eligibility criteria:
inclusion criteria: * individuals of diverse racial and cultural backgrounds * diagnosed with a developmental disability * over 18 but under 24 * have the capacity to provide informed consent exclusion criteria: * persons who are caucasian * do not have a developmental disability * older than 24 years of age * unable to provide informed consent

Keywords: stem career interest underserved populations education
comparing two ways of controlling blood sugar with insulin in patients admitted to the intensive care unit

Conditions: Critical Illness; Hyperglycemia

Summary: the purpose of this study is to determine if there is any difference between two ways of controlling blood sugar with insulin. in patients admitted to the intensive care unit, blood sugar levels often rise due to the stress of illness or surgery. studies have shown that patients do better if their blood sugar is kept normal. in order to maintain normal blood sugar levels, the investigators often give insulin (a substance made by the body), and they decide how much to give based on how high the blood sugar is. this study will compare two different ways of deciding how much insulin to give and compare how well each method keeps the blood sugar in a normal range. both ways of controlling blood sugar are institutionally-approved protocols and part of routine care.

improved outcomes have been demonstrated with tight control of blood glucose in critically ill patients. a number of look-up algorithms based on hourly glucose measurements and titrated intravenous insulin have been developed for the intensive care unit (icu). despite the numerous published algorithms, no study has investigated which algorithm results in optimal glycemic control in critically ill patients. the purpose of this trial is to compare two institutionally approved intravenous insulin administration algorithms and describe subsequent glycemic control. we hypothesize that the protocol that allows for variable insulin administration for a given blood glucose (multiple algorithms) will be associated with more optimal glycemic control. optimal glycemic control will be defined by time spent within a predetermined blood glucose range. in addition, the number of hypoglycemic episodes and mean and maximum blood glucose concentrations will also be measured. this trial will determine which insulin infusion algorithm is most effective in terms of glycemic control, and allow for standardization of glucose management in accordance with best practice.

Eligibility criteria:
inclusion criteria: * all patients admitted to the 7mb d/e icu will be eligible for this study
modification of doses of efavirenz according to its blood concentration in hiv patients

Conditions: HIV

Summary: this is a study on the utility of the modification of doses of efavirenz guided by its plasma concentration (therapeutic drug monitoring) in hiv-infected patients initiating treatment with sustiva.

currently, efavirenz is dosed systematically, without taking into account the individual characteristics of each individual patient. however, plasma concentration of efavirenz may widely vary between different subjects that receive the same dose of the drug (interindividual variability). therapeutic drug monitoring (tdm) signifies individualised pharmacological dosing, based on the plasma levels that each patient presents. this strategy has been broadly used in the field of the treatment of other medical conditions and is acquiring growing interest in the field of antiretroviral treatment. thus, the use of tdm for the treatment of naïve patients with nelfinavir or with indinavir has translated into an increase in the proportion of individuals with suppressed viral load and also into a reduction in haart-induced adverse events . however, data on the utility of the therapeutic monitoring of the levels of efavirenz in hiv-infected patients are very scant. on the basis of the above, it might be thought that the modification of the doses of efavirenz, guided by its plasma concentration, in patients receiving this drug and whose plasma levels of efavirenz are outside the therapeutic range, might improve the tolerability of the treatment without compromising virological efficacy.

Eligibility criteria:
inclusion criteria: * hiv-1 patients. * according to the criteria of the treating physician, the need to initiate a regimen of antiretroviral treatment that includes efavirenz (both antiretroviral-naive patients and others on treatment with protease inhibitors switching to efavirenz for salvage reasons or for simplification of the anti-retroviral therapy are included). * absence of opportunistic infections and/or tumours in the three months prior to inclusion. exclusion criteria: * history of allergic hypersensitivity to the investigational drug. * history of previous failure with antiretroviral treatment with non-nucleoside reverse transcriptase inhibitors or previously documented resistance to efavirenz * history of psychiatric comorbidity which, in the investigator's opinion, renders the use of efavirenz inadvisable. * active consumption of alcohol (\>50 g/day) or other illegal drugs (except cannabis) * suspicion of unsuitable compliance with the antiretroviral treatment. * pregnant women or breast-feeding mothers.

Keywords: therapeutic drug monitoring treatment naive treatment experienced hiv
identification of a biomarker associated with cis-duplication of the smn1 gene

Conditions: Spinal Muscular Atrophy

Summary: spinal muscular atrophy (sma) is a neuromuscular disorder characterized by loss of motor neurons in the anterior horn of the spinal cord and leading to muscle atrophy. sma has an autosomal recessive inheritance and affects 1 in 6000 infants with a carrier frequency of 1 in 40. in most cases, it is caused by homozygous gene deletion or gene conversion of the smn1 gene (0+0 genotype) on 5q11-q13. this genomic region has been duplicated and inverted during evolution. thus the smn1 gene has a very homologous copy, called smn2. genetic counseling aim at detecting carriers with only one copy of the smn1 gene (0+1 genotype). sma carrier testing relies on total copy number quantification of the smn1 copies by quantitative pcr methods. nevertheless, cis-duplication of the smn1 gene on one allele and deletion on the second allele (2+0 genotype) can lead to a misinterpretation as molecular methods show 2 copies of the smn1 gene and cannot detect the carrier status. the aim of the study is the characterization of a biomarker specific of the cis-duplication of the smn1 gene in order to allow the detection of this 2+0 genotype which constitutes a trap for genetic counseling. we will use molecular combing to identify a genomic morse code (gmc) composed of a combination of probes specific of a structural motif on the cis-duplication chromosome. the characterization of this gmc is based on the comparison of two sample groups: * the test group, with a maximum of 137 individuals carrying 3 copies of the smn1 gene (suggesting a cis-duplication on one allele) * the control-1 group, with a maximum of 137 individuals carrying 2 copies of the smn1 gene a pilot study performed on 24 samples in the two groups is needed to define the exact sample number necessary for statistical analysis of the study. when the gmc will be characterized, its specificity will be evaluated by testing two sample groups: * the test group, with 37 individuals carrying 3 copies of the smn1 gene * the control-2 group, with 37 individuals carrying 3 copies of the smn2 gene molecular combing needs long dna fibers and usual methods for dna extraction are not appropriate. this project requires new blood samples for specific dna extraction. if this project is successful, during a second project, this gmc will be converted into a simple and cheap pcr-based method. we will then evaluate the sensitivity of this method on our sample collection, notably on individuals with the 2+0 genotype defined by familial genotyping.


Eligibility criteria:
inclusion criteria: * adult individual * individual with either 2 copies of the smn1 gene (control-1 group), 3 copies of the smn1 gene (test group), or 3 copies of the smn2 gene (control-2 group). * individual with a social insurance * signed consent form exclusion criteria: * pregnant women, nursing women * individual without freedom by administrative decision or judicial decision or individual under administrative supervision or legal guardianship
identification of volatile organic compounds in exhaled air during exacerbation of chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: exacerbations of the disease are a hallmark of chronic obstructive pulmonary disease (copd), affecting the decline of pulmonary function, quality of life and increasing morbidity. the use of validated biomarkers could help to identify the etiology of exacerbation and to prescribe antibiotherapy when indicated. the analysis of exhaled air allows measuring different volatile organic compounds (voc) which reflect local or systemic inflammation and oxidative stress. the relationship between the presence of some of these compounds and the exacerbation of copd has never been studied. the aim of this study is to identify a cluster of voc in copd patients during an acute exacerbation of the disease, compared to a stable condition (3 months after discharge). investigators also will seek for a relationship between voc and the etiology of exacerbation (bacterial, viral, inflammatory).


Eligibility criteria:
inclusion criteria of copd group: * copd stages 2 and 3 of gold score (30 ≤ forced expiratory volume at one second (fev1) \< 80% of predicted value), * exacerbation confirmed clinically (increased dyspnea, cough or expectorations \> 48 hours) inclusion criteria of non copd group: * no smoker (\<100 cigarettes/year) exclusion criteria of copd group: * diagnosis of copd not confirmed. * instable clinical status with respiratory failure and indication of mechanical ventilation. * bronchodilator treatment changed * antibiotic treatment started in the 10 last days before admission exclusion criteria of non copd group: * chronic inflammatory disease * any respiratory disease * oral corticosteroid treatment during the last month

Keywords: chronic obstructive pulmonary disease copd volatile organic compounds exacerbation
phase 2 study of a new ophthalmic formulation of cyclosporine (restasis® x) in patients with dry eye disease

Conditions: Dry Eye Syndromes

Summary: this study will evaluate a new ophthalmic formulation of cyclosporine (restasis® x) in patients with moderate to severe dry eye disease in two stages. up to 3 doses will be studied in stage 2 based on results from stage 1. no patients participating in stage 1 will participate in stage 2 of this study. this study was terminated and stage 2 of the study was cancelled.


Eligibility criteria:
inclusion criteria: * moderate to severe dry eye disease in both eyes * best-corrected visual acuity (bcva) of 20/100 or better in each eye exclusion criteria: * use of any cyclosporine preparations within 3 months * use of topical medications, other than artificial tears, in the eyes within 1 month * use of contact lenses in either eye within 1 month * stage 2 only: participation in stage 1 of this study