Kornimate/medical-research-clean huggingface dataset:
treatment of high-risk moderate acute malnutrition using expanded admission criteria

Conditions: Malnutrition

Summary: this project explores whether children have better growth and cognitive development when the clinic identifies "higher risk" mam children and support them either with the same treatment as sam children or with the recommended practice: nutrition counseling.

this is a cluster-randomized controlled trial taking place in 20 community clinics providing malnutrition care in sierra leone. all participants will be children aged 6-59 months. control participants will have moderate acute malnutrition (mam), defined as mid-upper arm circumference (muac) 11.5-\<12.5. high risk mam will be defined with a muac 11.5 to \<11.9 or waz\<-3.5 or mother not the caretaker or not breastfeeding at \<2 years old. low risk mam defined with a muac 11.9 to \<12.5 with no risk factors. control group and low risk group caregiver's will received nutrition education via mother care groups every two weeks for 6 weeks and will be followed up 12 and 24 weeks post-enrollment. high risk group will receive 1 week supply of amoxicillin at enrollment and 1 sachet of rutf per day till muac is equal to or greater than 12.5 or up to 12 weeks of treatment. their caregiver will also receive nutrition education via the mother care groups. the investigators will also follow up with the participant at 12 and 24 weeks post-enrollment. a subset of the participants in each group will also be enrolled in a cognitive development substudy were the investigators will be using a eye tracking performance assessment. investigators will also enroll health adult participants for eye tracking assessment. adult data will be used as a reference when interpreting results.

Eligibility criteria:
inclusion criteria: * uncomplicated mam (based on muac equal to or greater than 11.5 cm and \<12.5) exclusion criteria: * currently involved in another research trial or feeding program * medical complication such as oedema, severe nausea/vomiting, severe dehydration, or severe pneumonia * have a diagnosed or visible sign of developmental delay * have a history of peanut or milk allergy
acute effects of benzbromaron on the pulmonary circulation

Conditions: Idiopathic Pulmonary Arterial Hypertension

Summary: actual studies suggest that a calcium activated chlorid channel (tmem16a) may play a relevant role in the pathogenesis of pulmonary arterial hypertension (pah). the inhibition of this channel led to pulmonary vasorelaxation in preclinical studies. benzbromarone is a well known inhibitor of the tmem16a channel and is used in patients with gout. in this pilot study the investigators plan to investigate if benzbromarone has an acute effect on the pulmonary arteries in humans. this will be investigated within the frame of a right heart catheterization performed in patients with known pah due to clinical reasons. the investigators hypothesize that the application of benzbromarone leads to pulmonary vasodilation, which can be recognized by the decrease in pulmonary vascular resistance. in addition, the change in pulmonary and systemic arterial pressure, pulmonary arterial wedge pressure, heart rate and arterial oxygen saturation will be assessed. due to clinical reasons patients will receive no (15 ppm) during right heart catheterization. hemodynamic changes upon no and benzbromarone may be compared.


Eligibility criteria:
inclusion criteria: * written informed consent * known pulmonary arterial hypertension * right heart catheterization indicated due to clinical reasons exclusion criteria: * known allergy against benzbromaron, gelborange s or other ingredient of the used drug (benzbromarone al) or a drug with similar chemical structure * severe renal insufficiency (gfr\<30ml/min/kg) * renal diathesis * severe hepatic disease (bilirubin \>1.6 mg% or ast or alt \> 3x norm) * known pregnancy * uncontrolled systemic arterial hypertension (\>150 mmhg systolic or 95 mmhg diastolic) * uncontrolled ventricular arrythmia * uncontrolled bradycardic or tachycardic supraventricular arrythmia * myocardiac infarction within the last 12 months * pulmonary embolism within the last 6 months * ongoing iv. or sc. prostanoid therapy for pah * pulmonary hypertension other than pah
effects of stimulant dependence on human striatal dopamine system - 15

Conditions: Amphetamine-Related Disorders; Tobacco Use Disorder

Summary: the purpose of this study is to determine whether dat availability, assessed by win binding, in the striatum is altered in cocaine or methamphetamine dependence. to determine whether da synthesis capacity, assessed by fdopa uptake, in the striatum is altered in coc or meth dependence. to determine whether the pet tracers, win or fdopa, will differentiate meth induced alterations from those induced by coc use. to determine whether the pet characterization of striatal alterations observed at 3-5 days since last drug use persists at least 3 months after last drug use.

4-5 day inpatient study. participant will have scanned pictures (mri \& pet scans) taken of their brain after being injected with a small amount of win, a radioactive substance. participants give daily urine samples and fill out health related questionnaires. it is important to determine whether the alterations characterized within one week of last drug use persist over a longer time period. based on results of the studies from aims 1 \& 2, we will decide which of the 2 probes, win or fdopa-pet is the more sensitive index of stimulant-dependency-induced changes.

Eligibility criteria:
inclusion criteria: m/f, ages 21-50. meet dsm-iv criteria for methamphetamine and nicotine dependence. agree to conditions of the study and sign informed consent. exclusion criteria: psychiatric disorder that requires medication therapy. history of seizures. pregnant and/or nursing women. dependence on etoh or benzodiazepines or other sedative/hypnotics. acute hepatitis. other medical conditions that deem participation to be unsafe.

Keywords: amphetamine dependence
real world environmental exposure study with healthy and cystic fibrosis subjects

Conditions: Cystic Fibrosis, Pulmonary

Summary: cystic fibrosis (cf) is the most common autosomal recessive disease that leads to early mortality in caucasians and affects around 7500 patients in france. progression of the disease depends on pulmonary exacerbations defined as acute deterioration of respiratory symptoms which ultimately impair lung function and quality of life. most frequently caused by lung bacterial infections, exacerbations' effects include increased cough, increased sputum production, increased use of antibiotics, dyspnea and decreased lung function. the phenotypic variability of cf suggests the implication of other contributors especially to the cf airway disease. beside genetic and epigenetic alterations, environmental factors - e.g tobacco smoke, air pollution, temperature changes, food intake - appear as relevant candidates. a previous review has discussed current knowledge on the effects of air pollution on the course of cf disease. although scarce, the existing epidemiological andexperimental literature suggests a link between exposure to air pollutants and adverse health effects.although scarce, the existing epidemiological and experimental literature suggests a link between exposure to air pollutants and adverse health effects. the eu sponsored remedia project (impact of exposome on the course of lung diseases, grant agreement id 874753) contributes to the understanding of the influence of the exposome on chronic obstructive pulmonary disease (copd) and cf. objective of work package 3 within the remedia project is the development of a mobile environmental sensor toolbox that is capable to assess the external exposome. the biomarkertoolbox was developed and tested in a proof-of-concept study carried out in healthy volunteers. the next step is to validate the collectionof exhaled breath condensate (ebc) in a real-life study. in this aim, the objective of the present study will be to assess the feasibility of ebc collection in cf patients and healthy individuals


Eligibility criteria:
inclusion criteria: * normal blood test * negative cotinine test * protocole (riph2) * normal ecg * normal alcohol test * lung function with fev1 predicted ≥ 40% at spirometry. exclusion criteria: * none

Keywords: cystic fibrosis environmental exposure exhaled breath condansate levels of 3-nitrotyrosin, hexanal, neutrophil elastase level of hexanal level of neutrophil elastase
an extension study assessing the safety and efficacy of avtx-803 in subjects with leukocyte adhesion deficiency type ii

Conditions: Leukocyte Adhesion Deficiency

Summary: the primary objective of this extension study is to assess the long-term safety and efficacy of avtx-803 in subjects with lad ii (slc35c1-cdg).


Eligibility criteria:
inclusion criteria: * subject must have completed protocol avtx-803-lad-301 * subject has biochemically and genetically proven lad ii (slc35c1-cdg) exclusion criteria: * subject has severe anemia defined as hemoglobin \<8.0 g/dl (\<4.9 mmol/l) * subject has impaired renal function as defined by an egfr \<90 ml/min * subject has known or suspected intolerance or hypersensitivity to fucose or any ingredients of the investigational product * in the investigator's opinion, subject has a history of failure to respond to fucose at adequate dosing
surgical treatment for hallux rigidus

Conditions: Hallux Limitus; Hallux Rigidus

Summary: the purpose of this study is to examine the long-term outcomes for the surgical treatment of end stage degeneration in the big toe joint.

hallux rigidus is a degenerative process that occurs in the first metatarsophalangeal joint (mtpj). there are a variety of surgical treatment options available for its treatment including joint sparing and joint destructive procedures. patients with end stage arthritis are often given several surgical options for the treatment of the first mtpj. the procedures are correlated to the patient's age, type of shoe gear, activity level, body mass index, degree of arthritis, desire for joint mobility and bone density. this proposal outlines a retrospective study on the long-term efficacy of joint resection, joint fusion, and hemi-metallic first mtpj implants. a multi-center study of 300 subjects who received surgical repair for end stage arthritis of the first mtpj will be evaluated. subjective assessment for pain, function and alignment as well as objective radiographic evaluation will be performed. further, the frequency and types of adverse events associated with the three surgical techniques will be assessed. the results of this study will provide valuable information to foot and ankle surgeons in making appropriate decisions regarding the treatment options for end stage hallux rigidus.

Eligibility criteria:
inclusion criteria: * end stage hallux limitus/rigidus * status post 1 year since having the surgery * must have had a joint resection, fusion, or hemi-metallic implant exclusion criteria: * history of seropositive or seronegative arthritis * have had a primary surgery before then had one of the above surgeries performed

Keywords: arthritis degeneration
safety and efficacy of intravitreal lfg316 in wet age related macular degeneration (amd)

Conditions: Neovascular Age-elated Macular Degeneration (Wet AMD); Exudative Macular Degeneration

Summary: this study will assess the safety and efficacy of lfg316 in patients with age related macular degeneration.


Eligibility criteria:
inclusion criteria: * best corrected visual acuity (etdrs scale) of 60 letters or less in the study eye. * an active choroidal neovascular membrane attributable to neovascular amd in at least one eye. * history of treatment (at any time) with at least 3 doses of anti-vegf therapy in the study eye. exclusion criteria: * history of recurrent non-response to anti-vegf therapy in the study eye. * in the study eye, retinal disease other than amd (benign conditions of the vitreous and peripheral retina are not exclusionary). * choroidal neovascularization due to a cause other than amd. * in the study eye, media opacity that, in the investigator's opinion, could interfere with conduct of the study. * history of infectious uveitis or endophthalmitis in either eye. * any of the following treatments to the study eye within 28 days prior to dosing: ranibizumab, bevacizumab, pegaptanib or other vegf inhibitor. * any of the following within 90 days prior to dosing: photodynamic therapy or laser photocoagulation in the study eye; intravitreal steroid in the study eye; or intraocular surgery (including cataract surgery) in the study eye

Keywords: age-related macular degeneration intravitreal, neovascular anti-vascular endothelial growth factor wet amd age-related macular degeneration intravitreal neovascular
pharmacokinetics of insulin detemir in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in japan. the aim for this trial is to investigate the pharmacodynamics and pharmacokinetics of insulin detemir and insulin nph in japanese subjects with type 1 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus * hba1c (glycosylated haemoglobin) maximum 9.0% * duration of diabetes at least 1 year * body mass index (bmi) maximum 25.0 kg/m\^2 exclusion criteria: * recurrent severe hypoglycaemia * proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator * impaired hepatic function * impaired renal function * cardiac problems * uncontrolled treated / untreated hypertension * hepatitis b surface antigen, hepatitis c antibodies or hiv (human immunodeficiency virus) antibodies, positive * known or suspected allergy against the trial products or related products including the components * previous history of serious allergy or anaphylactic reaction * any disease or condition which the investigator feel would interfere with the trial participation or evaluation of the results * severe late-phase diabetic complications including nephropathy * blood donation of more than 400 ml (inclusive) in total within the last 12 weeks or more than 200 ml (inclusive) in total within the last 3 weeks * known or suspected alcohol and illicit substance abuse or dependence * pregnancy, breast-feeding (within a year after labour) or the intention to become pregnant * the receipt of any investigational drug within the last 12 weeks prior to this trial * current or anticipated treatment with systemic corticosteroids
reliability of ius in crohn's disease

Conditions: Crohn Disease (CD)

Summary: transabdominal intestinal ultrasound (ius) is gaining acceptance as a point-of-care test to objectively assess disease activity in crohn's disease (cd). in order to incorporate individual parameters in a future definition of transmural healing, and for the consistent application of ius as a modality to assess treatment outcomes and establish therapeutic targets to ensure comparability between future studies, the inter-observer agreement should be determined for all relevant parameters.


Eligibility criteria:
inclusion criteria: * crohn's disease evolving for at least 1 months * patient older than 18 years * patient covered by french national health insurance * written informed consent exclusion criteria: * pregnant women or breastfeeding * minor * patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)

Keywords: crohn's disease intestinal ultrasound bowel wall thickness
systematic early use of neuromuscular blocking agents in ards patients

Conditions: ARDS

Summary: the use of neuromuscular blocking agents (nmba) in ards patients has not been extensively investigated. the aim of the study is to show a reduction of the mortality rate of ards patients.

the use of neuromuscular blocking agents (nmba) in ards patients has not been extensively investigated. it has been recently demonstrated that a systematic 48-h infusion of nmba is associated with a significant improvement in oxygenation as compared with a control group (gainnier et al., crit care med 2004). moreover, a trend towards a reduction in the mortality rate has been observed. the aim of the study is to show a reduction of the mortality rate of ards patients.

Eligibility criteria:
inclusion criteria: * ards with a pao2 / fio2 \ 5 since less than 48 hrs * informed consent exclusion criteria: * nmba allergy * continuous administration of nmba for ards prior inclusion * age \< 18 yrs * saps ii \> 70 * persistent air leak

Keywords: ards mortality mechanical ventilation pneumonia muscle relaxants
intermittent preventive treatment with azithromycin-containing regimens in pregnant women in papua new guinea

Conditions: Malaria in Pregnancy; Sexually Transmitted Infections; Anaemia

Summary: the purpose of this study is to determine whether repeated courses of sulphadoxine-pyrimethamine (sp) in combination with azithromycin given at antenatal clinic, leads to lower rates of low birth weight deliveries (\<2.5 kg) among papua new guinean women, than the current standard treatment of sp and chloroquine.


Eligibility criteria:
inclusion criteria: * pregnant * 14-26 weeks'gestation * permanent resident of study area * exclusive use of study health facilities for primary health care * age is between 16 and 49 years exclusion criteria: * known chronic illness, e.g. tb, diabetes, renal failure * severe anaemia requiring hospitalisation (hb \< 6 g/dl accompanied by symptoms requiring urgent treatment) * permanent disability, that prevents or impedes study participation and/or comprehension * known multiple pregnancy

Keywords: plasmodium falciparum plasmodium vivax azithromycin sulphadoxine pyrimethamine low birth weight haemoglobin chlamydia trachomatis neisseria gonorrhoeae treponema pallidum
prevalence rates of usi, bo, do and their clinical and urodynamic findings in women with ≥stage ii cystocele

Conditions: Lower Urinary Tract Symptom in Severe Cystocele Women

Summary: prevalence rates of urodynamic stress incontinence (usi), bladder oversensitivity (bo) /detrusor overactivity (do) or both and their related clinical and urodynamic findings in women with ≥ pelvic organ prolapse quantification stage ii cystocele are important for clinical consultation. thus, the aim of this study was to elucidate the above findings and between-group associations.

between november 2011 and january 2017, medical records of all women with ≥stage ii cystocele who underwent 20-minute pad testing and urodynamic studies in a medical center were reviewed. anova test and post-hoc testing with bonferroni's correction were used for statistical analysis. usi included evident usi and occult usi, which were classified according to pad weight before and after prolapse reduction. bo was defined as \<300 ml of the volume at strong desire to void during filling cystometry. those women without usi, bo or do were allocated into the no demonstrated usi+bo/do group.

Eligibility criteria:
inclusion criteria: 1. age \>20y/o 2. severe cystocele, ie, more than stage 2 3. complete pad test and urodynamic study exclusion criteria: 1. pregnancy 2. urinary tract infection 3. had received pelvic reconstruction

Keywords: cystocele urodynamic stress incontinence detrusor overactivity pad test urodynamic study
targeted feedback reports to improve acute coronary syndromes (acs) care

Conditions: Acute Coronary Syndromes

Summary: this project is designed to examine the impact of tailored feedback on site performance. the investigators' objective is to evaluate whether a 'personalized and targeted' feedback, education and performance improvement intervention has a greater impact on adherence to recommended guidelines than standard feedback. the investigators hypothesize that a site-specific report with centrally identified targets for improvement paired with target specific interventions will enable sites to quickly identify and prioritize salient problem areas, have ready access to an analysis of factors that underlie problems, and formulate an effective action plan. the investigators also hypothesize that those hospitals randomized to receive intervention will be more likely to improve their overall performance, as well as their target specific performance, during the period of observation in direct response to activated qi processes. outcomes: the primary outcome is improvement in the overall composite of all metrics eligible for intervention regardless of their selection as targets. the secondary outcome is improvement in the composite of targeted metrics. outcomes will be assessed in all participating sites, and in among relevant performance subgroups (low performers, academic centers, full service, and among medication versus process metrics).


Eligibility criteria:
inclusion criteria: * hospitals participating in the action registry gwtg exclusion criteria: * sites with low volume of data submission (\< 10 data forms in the past year)

Keywords: quality improvement
proper dietary management, follow-up, and lactase enzyme supplementation for lactose intolerance

Conditions: Lactose Intolerant; Lactose Malabsorption; Lactose Intolerance

Summary: lactose intolerance (li) is considered the clinical syndrome caused by lactose malabsorption (lm). it is possible to identify four causes of lactase deficiency defining four different types of lm: primary (genetic), secondary (acquired), congenital (alactasia), and developmental (in premature infants, so reversible). the aim of this protocol is to investigate through an anonymous online survey the knowledge of the italian population on clinical, pathophysiological, diagnostic and therapeutic issues of lactose intolerance. data collected will be divulgated through a publication for both people with il and nutritionists, enriched with tables and flow charts, to improve the knowledge on lactose intolerance and to support people suffering from this condition. the results of this survey will guide subjects suspected of suffering from lactose intolerance towards a correct diagnosis and a better management.


Eligibility criteria:
inclusion criteria: * subjects must be adults (≥18 years of age) * willingness to complete the online survey exclusion criteria: * subjects \<18 years of age * subjects not available to answer the online survey
a non-interventional study on avelumab use in patients with advanced or metastatic urothelial carcinoma

Conditions: Urothelial Carcinoma

Summary: a multicenter ambispective (retrospective and prospective) non-interventional study of patients with locally advanced or metastatic urothelial carcinoma (adv/muc) treated with avelumab in france, not impacting the treatment decision made by the treating physician and the medical management of treated patients.


Eligibility criteria:
inclusion criteria: 1. patient ≥ 18 years of age 2. patient with locally advanced or metastatic urothelial carcinoma (irrespective of tumor histology) whose disease has not progressed (ongoing stable disease, partial response or complete response) following completion of first-line platinum-based chemotherapy and who has been (retrospective), is (retrospective and prospective), will be (prospective) treated with avelumab. * for a patient alive at the moment of the inclusion in the study : the patient must be informed of the study, he/she must be given an information letter signed by the investigator and must not be opposed to the collection of his/her data * for a patient who died before the inclusion in the study : the patient (during his life time) must not be opposed in writing to the collection of his data. 3. patient benefiting from a social security scheme according to local regulations exclusion criteria: 4. for a patient alive at the moment of the inclusion in the study: patient without liberty, under tutelage, or unable to give oral consent. 5. patient enrolled in a prospective interventional clinical trial assessing an investigational product.

Keywords: avelumab non-interventional study effectiveness france maintenance immunotherapy bladder cancer