Kornimate/medical-research-clean huggingface dataset:
evaluating the chain of addiction care (cac)

Conditions: Hepatitis C, Chronic; Substance Use Disorders

Summary: the investigators want to evaluate the feasibility of a decentralised hepatitis c care pathway (the chain of addiction care (cac) pathway) in several addiction care centres in the east of the netherlands. secondary objective: to measure the impact of hepatitis c clearance on met (+metabolite) and bup (+metabolite) trough levels in patients on opioid substitution therapy (ost). this is an exploratory, observational study.

people who (have) inject(ed) drugs (pwid) are at high risk for hepatitis c infection. establishing adequate linkage to care in this population can be a challenge. many of these patients receive opioid substitution, hepatitis c treatment possibly influences pharmacokinetics of those substitutes. this protocol describes a study on hepatitis c in people who (have) inject(ed) drugs (pwid), consisting of two substudies. 1) an exploratory, observational study in which we evaluate the decentralised hepatitis c care pathway in addiction care centres. 2) an observational pharmacokinetic study in hepatitis c patients on opioid substitution therapy (ost) embedded within the first study. rationale: 1) many pwids are lost during the process of testing and linkage to care and do therefore not receive adequate hepatitis c treatment. decentralising care in addiction care centres deems hospital visits unnecessary, an approach that has become increasingly popular in this population over the last few years. this practice however has not yet been evaluated in the netherlands. 2) in the netherlands the pwid population is often treated for opioid addiction by opioid substitution therapy (ost) with methadone (met) or buprenorphine (bup). there is evidence that liver inflammation has a negative effect on pharmacokinetics of drugs. consequently, we hypothesize that hcv treatment results in reduced liver inflammation and a decrease in met and/or bup levels, which is clinically relevant in the pwid/ost population. objective: 1) to evaluate the feasibility of a decentralised hepatitis c care pathway (the chain of addiction care (cac) pathway) in several addiction care centres in the east of the netherlands. 2. to measure the impact of hepatitis c clearance on met (+metabolites) and bup (+metabolites) levels and craving in patients on ost. study design: this is an exploratory, observational study with a pharmacokinetic observational study embedded within the same population.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * able and willing to give informed consent * currently inject or previously injected drugs at least once, including nasal snorting of drugs using aids such as basepipes or straws. * visit the participating addiction care centre at least once during the study period exclusion criteria: * none
closed loop ventilation in patients with covid-19

Conditions: Covid19; ARDS

Summary: transpulmonary pressure may be higher in ards patients due to decreased respiratory system compliance. the hypothesis is that tidal volumes which are generated by intellivent- adaptive support ventilation (asv) are safe range by transpulmonary pressure.

patients will be enrolled in the first 24 hours of admission to the intensive care unit. apache-2 and saps-2 scores will be noted 24 hours after admission. covid-19 pneumonia will be confirmed according to world health organization (who) interim guidance. level of sedation will be monitored with ramsey sedation scale. an esophageal balloon will be inserted in order to measure transpulmonary pressure(ptp). the proper localization will be estimated according to ear-nose-xiphoid length. localization of the balloon will be confirmed with the baydur maneuver. mojoli methods will be used to optimize the balloon filling volume. all patients will be mechanically ventilated under intellivent-asv mode. initial settings will based on predicted body weight. 45 cmh2o will be determined as target end-tidal carbondiokside (etco2) but permissive hypercapnia will be allowed if necessary, to maintain lung protective ventilation. safe ph value will be determined 7.25 independent from etco2 levels in patients who will be applied lung protective ventilation. fio2 and peep will be set to maintain an spo2 of 88-92%. ptpinsp will be calculated by subtracting the esophageal pressure from the alveolar pressure measured during inspiratory pause maneuver. targeted inspiratory transpulmonary pressure (ptpinsp) was determined to be below 20 cmh2o. if ptpinsp exceeds 20 cmh2o, minute-volume (minvol) will be decreased by 10%. minvol will be reduced below 100% if necessary, to achieve the target. expiratory transpulmonary pressure (ptpexp) will be calculated by subtracting the esophageal pressure from the alveolar pressure measured during expiratory pause maneuver. targeted ptpexp was determined from 0 to 3 cmh2o. if ptpexp is below 0 cmh2o, peep will be increased until ptpexp is positive. if ptpexp exceed 3 mh2o, peep will be decreased until ptpexp is below 3 mh2o. transpulmonary pressure will be recorded at the beginning after that at least twice daily morning and evening visits. all measurement will be made in passive condition. transpulmonary pressure measurement will continue until the patient is awake.

Eligibility criteria:
inclusion criteria: * covid-19 is confirmed with rt-pcr -\>18 years of age * being intubated less than 24 hours * not being planned to be extubated in 24 hours exclusion criteria: * covid-19 is not confirmed with rt-pcr * having an impaired hemodynamic status * esophageal pathologies * bronchopleural fistula

Keywords: mechanical ventilation adaptive support ventilation transpulnonary pressure safety
rapid hiv tests for women late in pregnancy and during labor

Conditions: HIV Infections

Summary: this study will look at how well the oraquick hiv 1/2 antibody rapid test works and how women accept being tested for hiv late in pregnancy and during labor. for women with positive test results, the study will look at whether or not these women accept anti-hiv drugs and which drugs they receive.

a simple hiv test design and easily interpretable, fast results are logistical advantages in clinical settings such as the labor and delivery unit. a fast test result means that a woman can make important choices about her and her baby's medical care before she delivers her baby. if a woman finds out she has hiv, she can decide to take antiretroviral drugs before delivery to decrease the risk of passing hiv to her baby. these advantages are also important for women with little or no prenatal care who present for care late in pregnancy, but may not be inclined to return for a standard test result or adhere to subsequent prenatal visits. eligible women who elect to participate in this study will be enrolled in either the late presenter group (women who are not in active labor, and for whom delivery is not imminent) or the peripartum group (women who are in active labor with anticipation of delivery within 24 hours). step i for all women will include rapid hiv testing with oraquick hiv 1/2 and standard testing with enzyme-linked immunosorbant assay (eia) or western blot. women with a positive hiv test and their infants will be offered preventative antiretroviral therapy and enrollment into step ii. step ii will include clinical evaluations, laboratory evaluations, and an adherence assessment for the women and their infants. women in the late presenter group who participate in step ii will have one prenatal visit, a visit at labor and delivery, and three postpartum visits. women in the peripartum group who participate in step ii will have three postpartum visits. all infants in step ii will have five study visits through 24 weeks of age. all antiretroviral drugs will be obtained by prescription and will not be provided through this study.

Eligibility criteria:
inclusion criteria late presenter group: * unknown hiv serostatus * \>= 34 weeks gestation peripartum group: * unknown hiv serostatus * \>= 24 weeks gestation * in active labor or delivery expected within 24 hours infants: * maternal step i enrollment * positive maternal oraquick and/or eia/western blot result exclusion criteria late presenter group: * previous or current antiretroviral therapy for treatment of hiv infection * in active labor * evidence of ruptured membranes peripartum group: * previous or current antiretroviral therapy for treatment of hiv infection

Keywords: aids serodiagnosis pregnancy complications, infectious anti-hiv agents disease transmission, vertical
phase ii study of oral nafithromycin in cabp

Conditions: Community-Acquired Bacterial Pneumonia (CABP)

Summary: study to determine the safety, tolerability, pharmacokinetics and efficacy of oral nafithromycin versus oral moxifloxacin in the treatment of community-acquired bacterial pneumonia (cabp) in adults


Eligibility criteria:
inclusion criteria: meet the clinical criteria for cabp based on following: 1. clinical symptoms (new or worsening) 2. vital sign abnormalities 3. laboratory abnormalities 4. radiographic evidence of cabp 5. port score exclusion criteria: 1. subjects with any of the following confirmed or suspected types of pneumonia: 1. aspiration pneumonia 2. hospital-acquired bacterial pneumonia (habp) 3. healthcare-associated bacterial pneumonia (hcap) 4. ventilator-associated bacterial pneumonia (vabp) 5. pneumonia that may be caused by pathogen(s) resistant to either study drug 2. receipt of 1 or more dose(s) of a potentially effective systemic antibacterial treatment for treatment of the current cabp 3. suspected or confirmed non-infectious causes of pulmonary infiltrates 4. subjects requiring concomitant adjunctive or additional potentially-effective systemic antibacterial treatment for management of cabp
meeting protein targets in critically ill patients

Conditions: Critical Illness; Dietary Modification

Summary: this is a retrospective study of protein and energy intake in enterally fed critically ill adult patients before and after the introduction of a very high protein enteral nutrition formula in a single center medical/surgical icu.


Eligibility criteria:
inclusion criteria: * adult patients ≥ 18 years of age, mechanically ventilated * received enteral nutrition for a minimum of five days during the first week of icu admission exclusion criteria: * received parenteral nutrition during first week of icu admission * acute renal failure not dialyzed * hepatic encephalopathy grade 3 or 4 * intentional underfeeding/trophic feeding - including refeeding syndrome
the effect of light deprivation on visual functions in adult amblyopes

Conditions: Amblyopia; Anisometropia; Visual Impairment

Summary: amblyopia is a significant health problem, affecting up to 4% of the population in the united states. amblyopia, commonly known as "lazy eye," is a developmental visual disorder in which one or both eyes suffer from poor vision as a result of being disadvantaged in early life. strabismus, or eye misalignment, such as crossed eyes (esotropia) or wandering eyes (exotropia), and anisometropia, or a power difference between the eyes, are the most common causes of amblyopia. if conventional treatment, such as patching the better seeing eye, is not initiated during the critical period of visual development, lasting visual impairment may persist throughout life. this critical period of visual development has been thought to end around age 10. however, recent research has demonstrated that the critical period of visual development can be extended into adulthood. complete light deprivation in animal models has restored plasticity in the visual cortex and has demonstrated drastic recovery of vision in amblyopic eyes. the objective of this pilot study is to evaluate the impact of complete light deprivation on visual function in a cohort of human adults with severe amblyopia from anisometropia.


Eligibility criteria:
inclusion criteria: * amblyopia, defined as decreased vision, less than or equal to 20/100, in one eye secondary to anisometropia * age 18-50 years exclusion criteria: * strabismus * eye pathology, such as cataract, corneal disorder, maculopathy, glaucoma, * mental health diagnosis, such as depression, schizophrenia, bipolar disorder or anxiety disorder
rasagiline in the treatment of persistent negative symptoms of schizophrenia

Conditions: Schizophrenia

Summary: this is a study of a new medication for the treatment of cognitive impairments (thinking difficulties) and negative symptoms in people with schizophrenia. the new medication is rasagiline. rasagiline is a drug which has been approved by the food and drug administration for the treatment of parkinson's disease. it is used to treat cognitive problems.

the study will consist of two phases: a 4-week continued stability phase (lead-in phase) and a 12-week double-blind treatment phase. in the lead-in phase, subjects receiving antipsychotic medication, who manifest moderate to severe and persistent negative symptoms, will remain on their maintenance regimen for at least four weeks. the treatment phase will be a 12-week, parallel groups, double-blind, placebo-controlled trial of adjunctive rasagiline (1 mg/day), a selective mao-b oxidase inhibitor.

Eligibility criteria:
inclusion criteria: * subjects will meet dsm-iv criteria for schizophrenia or schizoaffective disorder. * current treatment with one or more second generation antipsychotics, except ziprasidone * on same second generation antipsychotic(s)for at least 56 days * on same dose of second generation antipsychotic(s)for at least 30 days * 22-item sans: total score (i.e.all items minus global items and poverty of content of speech)greater than 20 or global rating of affective flattening greater than or equal to 3 or global rating of alogia greater than or equal to 3 * bprs: sum of the four positive symptom items less than or equal to 16 (items 4,11,12,15) * bprs: sum of the four anxiety/depression factor items less than or equal to 14 (items 1,2,5,9) * simpson-angus scale: total score less than or equal to 8 exclusion criteria: * dsm-iv major depressive disorder within last 6 months * current treatment with ziprasidone * dsm-iv diagnosis of alcohol or substance dependence within the last 6 months * dsm-iv criteria for alcohol or substance abuse within the last month * evidence of illicit substance use, as identified with urine toxicology screen * history of an organic brain disorder, mental retardation,epilepsy, or a medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol. see those listed below * uncontrolled hypertension defined as bp exceeding 145/90 on 3 consecutive readings despite adequate treatment, pheochromocytoma, melanoma, hepatic insufficiency * pregnancy or lactation in females * pheochromocytoma * melanoma * hepatic insufficiency

Keywords: cognitive impairments negative symptoms
two methods of lip taping as a presurgical orthopedic appliance

Conditions: Cleft Lip and Palate

Summary: a randomized clinical trial to compare the effectiveness of two methods of lip taping as a presurgical orthopedic appliances on maxillary arch dimensions in infants with bilateral cleft lip and palate.

it is a multicenter randomized clinical trial with two parallel arms. the patients will be randomly divided into two groups, group one: a passive orthopedic appliance will be used with conventional steri strip, and group two will receive a passive orthopedic appliance with a custom-made tape consist of steri strip and orthodontic elastic. impressions will be taken before starting the treatment (t1) and at the end of treatment (t2) three months later. the effectiveness of the two methods of taping will be assessed and measured on digital models of the maxillary arch before and after the treatment.

Eligibility criteria:
inclusion criteria: 1. non-syndromic infants with complete bilateral cleft lip and palate. 2. both sexes. 3. age range from 1-30 day exclusion criteria: 1. infants with systemic syndromes. 2. infants with unilateral cleft 3. infants whom parents refuse to consent.
the glycocalyx in covid-19 patients. a pilot study

Conditions: COVID-19; Endothelial Dysfunction; Coagulation Disorder

Summary: the damage of the endothelial glycocalyx is based on microvascular endothelial dysfunction and typical for critical clinical conditions like sepsis, trauma, bleeding, shock, as well as ards. we aim to generate first hints regarding the impact of covid-19 disease on the (damage) of the endothelial glycocalyx. furthermore, we want to investigate the potential coagulopathies, which go along with shedding of the glycocalyx. the detection of and the relation between the severity of the disease, as well as the extent of the glycocalyx damage during the observational period, as well as the hemostatic alterations, are aim of the study.

the damage of the endothelial glycocalyx is based on microvascular endothelial dysfunction and typical for critical clinical conditions like sepsis, trauma, bleeding, shock, as well as ards. we aim to generate first hints regarding the impact of covid-19 disease on the (damage) of the endothelial glycocalyx. furthermore, we want to investigate the potential coagulopathies, which go along with shedding of the glycocalyx. the detection of and the relation between the severity of the disease, as well as the extent of the glycocalyx damage during the observational period, as well as the hemostatic alterations, are aim of the study.circulating plasma syndecan-1 is measured as surrogat parameter for the extent of the glycocalyx damage.

Eligibility criteria:
inclusion criteria: * covid-19 detected by pcr measures going along with clinical symptoms * age \> 18 years exclusion criteria: * refusal of study participation

Keywords: glycocalyx, covid-19, ards, icu, coagulation,
low dose total skin electron beam treatment (tsebt) followed by maintenance valchlor for patients with mycosis fungoides

Conditions: Mycosis Fungoides; Cutaneous T-cell Lymphoma

Summary: the clinical efficacy of mechlorethamine gel (valchlor) as a maintenance therapy after low dose total skin electron beam therapy (tsebt) for the treatment mycosis fungoides cutaneous t-cell lymphoma will be evaluated in this study. subjects will be treated with low dose tsebt (12 gy total) over a period of two weeks. after a 30 day observation period and confirmation that their disease stage has been downgraded to ia or ib, subjects will use valchlor as a maintenance therapy over the course of one year. the efficacy of valchlor as a maintenance drug will be followed clinically through modified severity weight assessment tool (mswat) and percent body surface area measurements (%bsa). furthermore, subjects will be followed histopathologically through skin biopsies performed at the screening visit, immediately after observation period, one month after the start of the maintenance period, and twelve months after the start of the maintenance period (4 biopsies total).


Eligibility criteria:
inclusion criteria: * 1. male or female * ≥ 18 years of age * documentation of diagnosis as evidenced by one or more clinical features consistent with mycosis fungoides cutaneous t-cell lymphoma * written informed consent obtained from subject or subject's legal representative and ability for subject to comply with requirements of the study * skin biopsy specimen of representative lesion obtained at screening of study and deemed diagnostic of mycosis fungoides by principal investigator * eligible, in the opinion of the investigator, for low dose tsebt over the course of two weeks. * availability of subject to be observed for up to 18 months post-screening evaluation. * life expectancy greater than 6 months exclusion criteria: * pregnant or breast-feeding females * presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data * patients diagnosed with sezary syndrome. sezary syndrome is equivalent to mycosis fungoides that develops to stage iva/b with b2 (high blood tumor burden) involvement, and as such requires a more aggressive treatment regimen than valchlor or tsebt. * patients who do not have their disease downgrade to stage ia or ib 30 days following low dose tsebt. * underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of the patient to undergo treatment * minimum 3 weeks since prior systematic treatment or phototherapy * decisionally-impaired individuals, prisoners, and vulnerable populations
chips or college health intervention projects

Conditions: Alcohol Abuse

Summary: the goal of the study is to test the efficacy of brief clinician advice in reducing the frequency of high-risk drinking and alcohol-related harm in a population of college students seeking care at five university health care clinics. high-risk drinking is defined as 1) 8 or more episodes of heavy drinking (5 or more drinks in a row) in the past 28 days for male and female students, and/or 2) 50 drinks for male and 40 drinks for female students in the past 28 days, and/or 3) 15 drinks for male and 12 drinks for female students in the past 7 days, and/or 4) one or more episode(s) of heavy drinking which includes 15 or more drinks in a row.


Eligibility criteria:
inclusion criteria: * subjects who screen positive for high risk drinking on the health screening survey (hss) and baseline interview exclusion criteria: * students who will be leaving campus due to graduation or for an extended absence prior to the first face to face intervention female students who are pregnant at the time of randomization students who are currently suicidal at the time of the baseline interview students under 18 years of age students who drink more than 200 drinks in 28 days (referred for treatment).