Kornimate/medical-research-clean huggingface dataset:
the efficacy of pro-vitamin a biofortified cassava on vitamin a status in nigerian preschool children

Conditions: Vitamin A Deficiency

Summary: the study comprises an open-label randomized controlled trial investigating the efficacy of consuming a daily ration of pro-vitamin a biofortified cassava on vitamin a status of nigerian children, aged 3-4 years old (n=200).

objective: the primary objective is to assess the efficacy of daily consumption of pro-vitamin a rich cassava during 10 weeks on body retinol pools of 3-4 year old children in nigeria after high-dose vitamin a supplementation. the secondary objectives are: 1) to investigate the effect of daily consumption of pro-vitamin a rich cassava on functional indicators such as nutritional anaemia and gut integrity; 2) to investigate the effect of zinc deficiency and genetic polymorphisms in the beta-carotene oxygenase 1 (bco1) and related genes on the efficacy of pro-vitamin a rich cassava consumption; 3) to compare the skin colour in the palm of the hand of each participant with their serum retinol levels using a handheld non-invasive spectrophotometer. study design: open-label (single-blinded) randomized controlled trial with two parallel groups study population: pre-school children, aged 3-4 years living in osun state area, south-western nigeria. children (n=750) will be screened for eligibility. out of these, n=250 will undergo a 4-week run-in phase. n=200 children will be randomly allocated to two different treatments: 1) yellow cassava providing \~50% of the recommended daily allowance (rda) for vitamin a; 2) white cassava. main study parameters/endpoints: the primary outcome was the difference in body retinol pools between groups 1 and 2 at the end of intervention; however, due to the inability to assess body retinol pools, the modified primary outcome is the difference in serum retinol concentrations between groups 1 and 2. other outcome measures include: other vitamin a status indicators (β-carotene, retinol binding protein, transthyretin), inflammatory markers, iron status indicators, anthropometrics, gut integrity, and thyroid function.

Eligibility criteria:
inclusion criteria: * aged 36 - 59 months (verified by birth certificates, vaccination cards or other formal documentation) * apparently healthy * parental informed consent exclusion criteria: * frequently absent (\>20% of feeding days) during run-in * children not assenting during blood collections * signs or history of infectious or systemic diseases (e.g. tuberculosis, sickle cell anaemia) * mental status that is incompatible with the proper conduct of the study * current participation in other research * food allergy related to the intervention foods

Keywords: pro-vitamin a cassava vitamin a deficiency retinol isotope dilution preschool children nigeria
association of copd maintenance medication adherence with resource use and cost among copd patients

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the aim of this study is to examine the association of copd maintenance inhalation medication (inhaled corticosteroid or ics) adherence with copd exacerbation healthcare resource utilization among copd patients with exacerbation history.

objectives: the primary objective of this study is to examine the association of copd maintenance inhalation medication (inhaled corticosteroid or ics) adherence with copd exacerbation healthcare resource utilization among copd patients with exacerbation history. study design: this study is a retrospective database analysis using 2014-2016 guangzhou city health insurance database. data source(s): guangzhou city health insurance database will be used for this study. all outpatient and inpatient visits for one patient during 2014-2016 were available. study population: this study will include patients with a physician copd diagnosis in guangzhou city health insurance database during 2015 and with complete treatment data during 1 year before and 1 year after the index date. the rough sample size of the study population was 49,000. outcome(s): 1. indicators of copd control: exacerbations; 2. health resource utilization: annual number of inpatient days, inpatient visit number, emergency department (ed) visit number; 3. costs: copd exacerbation hospitalization expenditures, all-cause hospitalization expenditure. statistical analysis: descriptive statistics will be used for all variables, as appropriate. continuous variables will be summarized by the number of observations, mean, standard deviation, median, minimum, maximum, first quartile and third quartile. categorical variables will be summarized by frequency counts and percentages at each category. number of patients and number of missing for each variable will be summarized. logistic regression will be used to estimate the risk of any hospitalization. generalized linear models (glms) with a gamma distribution and log link will be used to approximate the highly right-skewed distribution of medical expenditure. for exploratory objectives, propensity score matching (psm) will be used to explore the association of medication class and health resource utilization if applicable. the interaction of medication class \* adherence or subgroup analysis (by medication class) will be considered when conducting the regression model.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with copd in 2015; 2. patients had complete hospital visit data available during pre-index 1 year period and post 1 year follow-up; 3. patients had at least one copd exacerbation during 1 year prior to the index date; 4. patients had at least 2 copd maintenance medication claims during post index 1 year period, as 2 claims are recommended to calculate adherence. exclusion criteria: 1. inability to determine diagnoses from claims; 2. individuals with other chronic respiratory conditions such as respiratory cancer, pulmonary fibrosis, asthma.
campylobacter enteritis and post-infective bowel dysfunction (pi-bd): role of antibiotics and microbiota

Conditions: Campylobacter Infections; Irritable Bowel Syndrome

Summary: the principal research objective is to determine the impact of antibiotic use on the risk of developing long term bowel symptoms after infection with the germ campylobacter.

the secondary research objectives are: * to investigate how the particular strain of the campylobacter germ that causes the infection, and the strength of the immune response that it stimulates in the bowel, affect the risk of long term bowel symptoms. * to explore what changes occur after campylobacter infection in the bacteria that usually live in the large bowel (microbiota) and the chemicals that they produce (short-chain fatty acids) when they digest nutrients. we will look for differences between people who recover fully and people who have long term bowel symptoms.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * clinical syndrome suggestive of intestinal infection, including symptoms such as new onset of abdominal pain, vomiting, diarrhoea, blood in stools, fever * submission of stool sample to nottingham university hospitals microbiology laboratory for investigation of these symptoms * campylobacter sp. cultured by selective media (standard clinical practice) from this stool sample exclusion criteria: * pregnancy declared by the candidate * history declared by the candidate of pre-existing gastrointestinal disorder, including but not limited to: * inflammatory bowel disease * coeliac disease * pancreatitis * gallstone disease (biliary colic, cholecystitis) * diverticulitis * cancer of the gastrointestinal tract * irritable bowel syndrome * reported history of previous resection of any part of the gastrointestinal tract other than appendix or gallbladder * intestinal stoma * habitual use of opiate analgesics likely to alter bowel function e.g. morphine * use of antibiotics in the preceding four weeks other than for treatment of index infection. * use of purgative products/ high dose laxatives for bowel preparation in the four weeks prior to index infection. * any condition where the candidate is likely to require a course of antibiotics in the next 3 months e.g. severe chronic respiratory disease, recurrent urinary tract infection, lower limb ulceration * inability to complete the symptom questionnaires e.g. cognitive dysfunction limiting memory and understanding * declared participation in any medical trials in the past 3 months * anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g. cognitive dysfunction, chaotic lifestyle related to substance abuse

Keywords: antibiotics campylobacter diarrhoea enteritis microbiota calprotectin
treatment protocol and long-term outcomes in craniofacial fibrous dysplasia

Conditions: Craniofacial Fibrous Dysplasia

Summary: craniofacial fibrous dysplasia (cfd) is a nonneoplastic disease characterized by fibro-osseous lesions in the affected bones. treatment is mainly surgical and is stratified based on four different anatomical zones. this study aimed to evaluate the long-term outcomes and refine the algorithm for cfd.

according to chen et. al for the appropriate surgical management of fd the craniofacial skeleton can be divided into four zones according to the consideration of facial cosmesis, vital anatomical region and function preserving. the aim of the study was to evaluate the outcome of nearly 40 years long-term follow up cohort group and refine the algorithm of surgical intervention of fd under 4 zones classification.

Eligibility criteria:
inclusion criteria: * received cfd surgical intervention between 1972 and 2019 * personal interviews: between late 2019 and 2020, covering a postoperative period of over 20 years * all the surgery were performed by a senior surgeon (yu-ray chen) at chang gung craniofacial center exclusion criteria: * patients who underwent surgical treatment at other institutions during the follow-up period or those who did not return to the craniofacial outpatient department for follow-up and receive computed tomography scans between 2019 and 2020 will be excluded.

Keywords: craniofacial fibrous dysplasia optic nerve decompression hormone therapy
a study of irinotecan hydrochloride liposome in advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is an open label, dose-escalation and expansion, single centre, phase ia study . in this study, the tolerability, safety, pharmacokinetics and efficacy of irinotecan hydrochloride liposome injection were studied in patients with advanced solid tumors, to determine the dose-limiting toxicity (dlt) and maximum tolerated dose (mtd) of irinotecan hydrochloride liposome.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed solid tumors documented as advanced or metastatic disease; 2. subjects must be considered relapsed or refractory to standard therapies, have been intolerant to standard therapies, or have refused standard therapy; 3. ecog: 0-1; 4. adequate organ and bone marrow function; 5. sign an informed consent. exclusion criteria: 1. patients with brain malignant tumor, lymphoma or other malignant hematologic diseases; 2. active cns metastasis; 3. clinically significant gi disorders; 4. significant cardiovascular disease; 5. active infection or uncontrolled fever; 6. pregnant or breast feeding patients; 7. allergic to a drug ingredient or component; 8. the investigators determined that other conditions were inappropriate for participation in this clinical trial.
a prospective, multicenter registry with targeted temperature management after out-of-hospital cardiac arrest in korea

Conditions: Out-of-Hospital Cardiac Arrest

Summary: therapeutic hypothermia after out-of-hospital cardiac arrest is considered as a standard care. however, optimal candidates, optimal dose, duration, timing of initiation and rate of rewarming is still unknown. the objective of this project is to improve the outcomes for patients after resuscitation from out-of-hospital cardiac arrest treated with therapeutic hypothermia established from the analysis of multicenter registry data.


Eligibility criteria:
inclusion criteria: * age of older than 18 years * out-of-hospital cardiac arrest * comatose mentality after return of spontaneous circulation (rosc) * treated with therapeutic hypothermia, regardless of target temperature exclusion criteria: * suspected or confirmed to cerebrovascular accident * poor pre-arrest neurologic status (cpc\>3) * patients who are terminally ill or for whom intensive care dose not seem to be appropriate * do not attempt resuscitation (dnar) order * patients with tympanic membrane temperature below 30 degree celsius on admission

Keywords: therapeutic hypothermia
normal range of tsh and ft4 in pregnancy

Conditions: Hypothyroidism; Pregnancy Related; Thyroid; Dysfunction; Iodine Deficiency

Summary: physiological changes necessitate the use of pregnancy-specific reference ranges for thyrotrophin (tsh) and free t4 (ft4) to diagnose thyroid dysfunction during pregnancy. although many centers use fixed upper limits for tsh of 2.5 or 3.0 mu/l, this may lead to overdiagnosis or even overtreatment. the new guidelines of the american thyroid association have considerably changed recommendations regarding thyroid function reference ranges in pregnancy accordingly. any hospital or physician that is still using the 2.5 or 3.0 mu/l cut-off for tsh during pregnancy should evaluate their own lab-specific cut-offs. the investigator's objective is to establish a rational reference range of serum tsh for the diagnosis of subclinical hypothyroidism in the first, second, and third trimester of pregnant women in the sancaktepe region in turkey.

serum thyroid function tests (including t3, t4, tsh, anti-tpo) will be obtained from the singleton pregnancies in the first, second, and third trimester to determine the local specific normal ranges.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * free of pre-existing thyroid disease * that do not use thyroid interfering medication * that did not undergo ivf treatment * tpoab negative exclusion criteria: * adolescent pregnancy * patient with pre-existing thyroid disease * tpoab positive * patient using thyroid interfering medication * that had ivf treatment

Keywords: hypothyroidism pregnancy trimester thyroid dysfunction iodine level
crossover bioequivalence study of cevimeline 30 mg capsules under fasted conditions

Conditions: Dry Mouth

Summary: the objective of this study was to prove the bioequivalence of roxane laboratories' cevimeline 30 mg under fasted conditions


Eligibility criteria:
inclusion criteria: - no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to cevimeline or any comparable or similar product.
a study of efficacy and safety of mongersen (ged-0301) for the treatment of adult and adolescent subjects with active crohn's disease

Conditions: Crohn Disease

Summary: the purpose of study is to test the effect of an experimental medication ged-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active crohn's disease. the study will test ged-0301 compare to placebo for 12 weeks. the study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of crohn's disease. adolescent patients will also be allowed treatment with stable doses of exclusive enteral nutrition and growth hormone. all patients who complete the study will have the option to enter a long term active treatment study.


Eligibility criteria:
inclusion criteria: subjects must satisfy the following criteria to be enrolled in the study: * male or female ≥ 12 years * subject is able to swallow the ip tablets * active crohn's disease (cd) disease as determined by the crohn's disease activity index (cdai) score and the simple endoscopic score for crohn's disease (ses-cd) * must meet a determined average minimum number of daily stools or rating of abdominal pain over a 7day period * subject must have failed or experienced intolerance to at least one of the following: budesonide; systemic corticosteroids; immunosuppressants (eg, azathiopurine, 6-mercaptopurine, or methotrexate); or biologics for the treatment of cd (ie, infliximab, adalimumab, certolizumab, or vedolizumab). exclusion criteria: • the presence of any of the following will exclude a subject from enrollment: diagnosis of ulcerative colitis (uc), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis, or colitis due to immunodeficiency * local manifestations of crohn's disease (cd) such as abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy * subject has strictures with prestenotic dilatation, requiring procedural intervention, or with obstructive symptoms. in addition, subjects with colonic strictures that are not passable with an age-appropriate colonoscope, or strictures in the ileum or ileocecal valve that are fibrotic in nature, will be excluded * intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the screening visit * ileostomy or a colostomy * subject has a history of any clinically significant medical condition that, in the investigator's opinion, would prevent the subject from participating in the study * adolescents with delayed growth or pubertal development who are on corticosteroids at baseline and who should not continue treatment with the same dose of corticosteroids until the week 12 visit.

Keywords: crohn's disease ged-0301 mongersen adolescent pediatric children
validation of a diagnostic algorithm of giant cell arteritis

Conditions: Giant Cell Arteritis

Summary: giant cell arteritis (gca or temporal arteritis or cranial arteritis) or horton disease is a vasculitis that occurs in older adults, affecting vessels of medium and large caliber. the diagnosis of gca is a challenge for general practitioners and specialists. since 1970, it is based on a combination of clinical, biological and histological signs. temporal artery biopsy (tab) was the reference method until recently. however, tab has many drawbacks. therefore, researches of the past 20 years have been intended to develop alternative diagnostic methods. this was notably the case of the color doppler ultrasound (cdu) since the description by wolfgang schmidt of the halo sign. although european and british recommendations put cdu as second line method, many authors suggest the possibility to do without tab in many cases. in addition, many practitioners believe that it is not "ethical" to use an invasive unprofitable procedure like tab, and have already been using cdu in their routine practice. however, no diagnostic algorithm validating this approach in a prospective series has been published to date. therefore, the present study aim at validating a diagnostic algorithm of giant cell arteritis using color doppler imaging of temporal arteries and cervicocephalic axes as first screening method.


Eligibility criteria:
inclusion criteria: * ≥ 50 years * c reactive protein (crp) above normal * suspected of gca according to clinician expertise and / or aortitis arteritis or of one or more arteries from the aorta imaging (ct angiography, magnetic resonance angiography or positron emission tomography tdm18fdg) * benefiting from social security or receiving it via a third party * have given their participation agreement by understanding and accepting the constraints of the study exclusion criteria: * received corticosteroid dose ≥ 20 mg of prednisone equivalent for more than 7 days in the month before inclusion * underwent temporal artery biopsy before color doppler ultrasound * history of gca * terminal palliative phase or suffering from a disease or comorbidities such as life is involved in less than a year * patient with severe cognitive impairment * patient that can not be followed by the investigator for the duration of the study * refusal to participate in the study * with enhanced protection (namely those deprived of liberty by a court or administrative order, patient staying in a health or social institution, under legal protection, and patients in emergencies) * pregnant or breastfeeding women, women of childbearing age who do not have effective contraception * participating in another clinical trial.
study to investigate the safety, tolerability, absorption, distribution, metabolism, and elimination of rwj-445380 administered to patients with plaque psoriasis

Conditions: Chronic Small Plaque Psoriasis

Summary: the primary objective of the study is to evaluate the safety and tolerability of 50, 100, 200, and 300 mg/day doses of rwj-445380 for up to 12 weeks in patients with plaque psoriasis

trials with a new, first-in-class drug will be done to ascertain safety, tolerability, absorption and other effects in the treatment of psoriasis, such as effects on biomarkers. approximately 60 adult patients with psoriasis covering at least 3 percent of their body surface area will be recruited for the study. they will be randomly assigned to one of 5 treatment arms each patient has an equal chance of receiving the placebo, 50 mg, 100 mg, 200 mg, or 300 mg dose. patients will receive study medication in a blinded fashion, i.e, the patient, the doctor and the study sponsor will not know what group the patient is in until all patients complete the study. patients will take the medication daily for 12 weeks. the study will be enrolled in two enrollment groups of about 30 patients each, so that extent of side effects can be ascertained and expectations on their extent confirmed. the investigator and the sponsor will monitor the study for the occurrence of possible side effects. in addition to a screening visit, patients will have visits every week for the first month, and then every two weeks until 12 weeks of treatment. at 12 weeks, there are 2 visits on consecutive days for tests and there is one followup visit 4 weeks after the last dose of study drug is taken. medical history, physical examination, blood pressure and heart rate, and ecgs are checked periodically. blood samples will be taken for standard laboratory tests as well as special tests of the drug blood level, biomarkers to see whether the drug might be affecting the biological pathway of antigen presentation, and skin biopsies from areas both involved and not involved with psoriasis. the blood and skin samples will be used to see whether some of the characteristics of psoriasis are changed by taking the drug. samples will also be taken to see whether certain types of immune cells are affected by taking the drug. immunizations with tetanus and hepatitis a vaccines will be done to see if taking the drug might affect immune responses to these agents. patients will receive rwj-445380, 50, 100, 200, 300 mg, or placebo. patients will receive an oral capsule daily for up to 12 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of plaque psoriasis for at least 6 months * willingness to undergo tissue biopsies exclusion criteria: * no current oral or injectable medications for psoriasis (30 days to 3 months) * no other major health issues

Keywords: psoriasis skin auto immune