Kornimate/medical-research-clean huggingface dataset:
directly observed antiretroviral therapy among active drug users

Conditions: HIV/AIDS; Substance Abuse

Summary: the goal of this randomized, controlled trial is to compare the effectiveness of a community-based program of providing supervised antiretroviral therapy to hiv-positive drug users, compared to having the patients take the medicines on their own.

highly active antiretroviral therapy (haart) has dramatically reduced morbidity and mortality from hiv disease, but these benefits have not been conferred equally among all patient populations. injection drug users (idus) have shown particularly less favorable outcomes, with hiv progression remaining at high levels, and idu remains a significant risk behavior for the spread of hiv worldwide, with explosive epidemics in eastern europe, russia, and southeast asia. it is therefore essential to develop and test strategies of hiv treatment that optimize outcomes for this population, in order to reduce morbidity and mortality and to curb secondary transmission. directly observed therapy (dot) for tuberculosis has resulted in impressive improvements in adherence and clinical response and marked reductions in the development of resistance. the time-limited treatment of tuberculosis, the inherently different transmission patterns of tuberculosis and hiv, and the complexity of antiretroviral therapy have raised concerns about translating the dot model to hiv. successful, but non-comparative demonstration programs of directly administered antiretroviral therapy (daart) have been implemented in methadone maintenance programs, community-based settings, skilled nursing facilities, and in prisons. none of these, however, have targeted active drug users or used a prospective, randomized controlled trial (rct) design to rigorously determine the efficacy of daart as an intervention to improve hiv outcomes among active drug users. one rct of daart recently failed to demonstrate an impact on virological outcomes among low-income hiv+ patients, but these results are unlikely to be applicable to idus or other populations with demonstrated problematic adherence. we therefore conducted the first randomized controlled trial to address this question, consisting of six months of daart versus self-administered therapy (sat) among active drug users in a community setting. the objective was to determine the potential efficacy of a six-month daart program on hiv infection, using surrogate markers of hiv- rna levels and cd4+ t lymphocyte counts.

Eligibility criteria:
inclusion criteria: 1. being hiv seropositive; 2. being eligible for and/or being prescribed haart 3. living within the city of new haven 4. actively using heroin and/or cocaine in the previous six months 5. receiving no more than a twice-daily regimen exclusion criteria: not meeting inclusion criteria

Keywords: human immunodeficiency virus acquired immunodeficiency syndrome substance abuse directly administered antiretroviral therapy adherence, directly observed therapy
airsonea wheeze detection study

Conditions: COPD; Asthma

Summary: the purpose of this study is to determine if the airsonea device provides an objective assessment of breath sounds for the presence of wheeze in both medical and home environments.


Eligibility criteria:
inclusion criteria: * part i: participants presenting to an acute care setting with an exacerbation of asthma or chronic obstructive pulmonary disease symptoms * part ii: volunteer participants without asthma * part iii: participants with asthma * for all parts of study * age: 18 years or older * participant has signed an informed consent after having the study explained to them. exclusion criteria: * any medical finding by the physician that would exclude the patient from participating. * \< than 18 years of age
a study of ro4998452 in type 2 diabetes patients with varying degrees of renal impairment

Conditions: Diabetes Mellitus Type 2

Summary: this 4 arm study will investigate the pharmacodynamics and pharmacokinetics of ro4998452 in type 2 diabetes patients with varying degrees of renal impairment. eligible patients will be divided into 4 groups, with normal renal function, or mild, moderate or severe renal impairment. all patients will receive a single oral dose of ro4998452 in the fasted state.the anticipated time on study treatment is \<3 months (single dose study)and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 40-80 years of age; * type 2 diabetes; * normal renal function, or impaired but stable renal function; * stable with regard to medication or treatment regimen taken for renal impairment or diabetes. exclusion criteria: * patients with a renal transplant; * end-stage renal disease, requiring dialysis; * nephrotic syndrome, or a history of nephrectomy; * type 1 diabetes mellitus.
an evaluation of the efficacy and safety of csf-1 in the temporary correction of presbyopia (near-2)

Conditions: Presbyopia

Summary: this is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study evaluating the safety and efficacy of csf-1 in the temporary correction of presbyopia.


Eligibility criteria:
inclusion criteria: * subjects must have presbyopia. exclusion criteria: subjects must not: * have any contraindications to the study medications or diagnoses that would confound the study.
a safety and efficacy study for implantation and retrieval procedures using the venatech® retrieval filter system

Conditions: Pulmonary Thrombo-embolism

Summary: to establish the clinical safety and efficacy of the venatech® retrievable vena cava filter


Eligibility criteria:
inclusion criteria: * pulmonary thrombo-embolism with contraindication to anticoagulation. * failure of anticoagulant therapy in thrombo-embolic diseases. * prevention of pulmonary embolism in patients with a recent history ( \<3 months) of dvt/ pe who need to undergo urgent surgery at high risk of dvt/pe with temporary contra-indication to the use of therapeutic doses of anticoagulants. * emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and * chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated exclusion criteria: * the filter should not be implanted in patients with : * a vena cava which has a diameter \ 28 mm (due to the risk of device migration) * risk of septic embolism * known allergy to the materials contained in the kit, allergy to contrast media. * severely disabled patients whose life-expectancy, up to 6 months, appears limited according to the investigator's opinion. in addition, exclusion criteria are also extended to : * patients who cannot be regularly followed up by the participating center * subject who already has an implanted vena cava filter * subject who has a duplicated ivc * subject who has a contrast allergy to both iodinated contrast and non-iodinated contrast material * subject unable to understand information about participation in the study due to a language barrier, intellectual deficiency, psychiatric problems... * subject who has a renal failure (creatinemia clearance \< 30ml/min)

Keywords: venatech® retrievable vena cava filter safety efficacy
a study on the combination therapy of eravacycline for treating carbapenem-resistant acinetobacter baumannii pneumonia

Conditions: Pneumonitis; Acinetobacter Baumannii

Summary: this study intends to evaluate the efficacy and safety of eravacycline-based combination therapy in real words for chinese patients with crab pneumonia, providing data reference for clinical treatment of crab pneumonia.

this study aims to include 50 patients proven or suspected diagnosed carbapenem-resistant acinetobacter baumannii pneumonia at peking university third hospital. the physician determines to use a combination regimen of eravacycline, including sulbactam or compound preparations containing sulbactam, polymyxin b, and β-lactam antibiotics, is considered. the clinical response rate at the end of treatment is the primary endpoint of the study; the secondary endpoints include the clearance rate of carbapenem-resistant acinetobacter baumannii, the incidence of adverse events, and the all-cause mortality rate within 28 days.

Eligibility criteria:
inclusion criteria: 1. aged 18 years or older. 2. voluntarily participating in this study and signing an informed consent form. if the subject is unable to read and/or sign the informed consent form due to lack of capacity or other reasons, the informed process and the informed consent form must be signed by their legal guardian. 3. patients with clinical manifestations and imaging results consistent with bacterial pneumonia, and who are expected to benefit from antimicrobial treatment. suspected carbapenem-resistant acinetobacter baumannii infection or acinetobacter baumannii detected in two consecutive sputum cultures (at least one of which must be from bronchoalveolar lavage or endotracheal aspirate), with resistance to carbapenems. 4. patients who have been treated with eravacycline for at least 3 days. exclusion criteria: 1. the investigator believes that there are any medical history, current condition, treatment, abnormal laboratory test results, or other situations that may affect the trial results, interrupt the trial process (or the subject cannot complete all trial requirements, operations, and visits), or increase the risk to the subject from receiving the trial medication, including patients with terminal illness, or evidence of an immediately life-threatening disease. 2. patients with a history of allergic reactions to tetracyclines or any excipients contained in the formulation of the study medication.

Keywords: eravacycline
investigating accelerated learning and memory in healthy subjects using a face name memory task

Conditions: Healthy Adults

Summary: the purpose of this study is to investigate whether we can accelerate learning and improve associative memory performance in healthy subjects by applying transcranial direct current stimulation (tdcs) during a face name memory task.

associative memory refers to remembering the association between two items, such as a face and a name or a word in english and the same word in another language. it is not only important for learning, but it is also one of the first aspects of memory performance that is impacted by aging and by alzheimer׳s disease. for decades, neuroscientists have investigated associative learning and memory and ways to accelerate and enhance associative learning and memory. transcranial direct current stimulation (tdcs) is a non-invasive and painless electrical stimulation technique that has demonstrated to accelerate learning and improve memory in some studies. to investigate whether we can accelerate learning and improve associative memory using tdcs, we will compare the performance in a face name associate memory task from 2 groups. the first group will get active tdcs during the study phase of the face name memory task, whereas the second group will get sham tdcs during the study phase of the task.

Eligibility criteria:
inclusion criteria: * age: 18-35 years * native english speaker exclusion criteria: * history of severe head injuries, epileptic insults, or heart disease. * severe psychiatric disorders and severe untreated medical problems. * contraindications for tdcs (pregnant women, implanted devices)

Keywords: transcranial direct current stimulation (tdcs) accelerated learning memory
long-term follow up of the stability 1 trial

Conditions: LET; ACL Reconstruction; Osteoarthritis (OA) of the Knee

Summary: from 2014-2017, across 7 canadian and 2 european sites, we randomized 618 patients at high-risk of re-injury, to anterior cruciate ligament reconstruction (aclr) with or without a lateral extraarticular tenodesis (let) and demonstrated that the addition of the let reduced the risk of instability (rrr=0.38; 95% confidence interval (ci), 0.21-0.52; p=0.0001) and graft re-rupture (rrr, 0.67; 95% ci, 0.36-0.83; p=0.001). as a result, practice has changed; there has been a large increase in the proportion of orthopaedic surgeons recommending the addition of an let at the time of aclr and an increase in the number of patients requesting an let from their surgeon. there is some weak evidence suggesting that in the longer term, the let may increase the risk of developing osteoarthritis (oa) in that knee. knee oa affects over 4.4 million canadians and the number of younger adults being diagnosed with knee oa is growing and is a primary reason for seeking healthcare in canada. the impact of oa in canada is enormous and projected to cost canada $17.5 billion annually in lost productivity alone by 2031. this study will use imaging and patient-reported knee outcomes osteoarthritis score (koos) to evaluate the incidence of oa at 10-years post acl reconstruction with and without let. we will also collect information about overall knee health, patient-reported outcomes, costs associated with knee injury, rehabilitation and disability, clinical failure, functional ability, and sport participation. it is crucial that we understand the risks of developing knee oa associated with the addition of an let to an aclr so that surgeons and patients can make informed decisions, not just for their immediate post injury treatment of the failed ligament, but for the potential long-term consequences of that decision.


Eligibility criteria:
inclusion criteria: * acl deficient knee * skeletally mature to 25 years of age * 2 or more of: * competitive pivoting sport * grade 2 pivot shift or greater * generalized ligament laxity - beighton score of 4 or greater exclusion criteria: * previous acl reconstruction on either knee * multi-ligament injury (two or more ligaments requiring surgical attention) * symptomatic articular cartilage defect requiring treatment other than debridement * greater than 3 degrees of asymmetric varus * unable to complete outcome questionnaires

Keywords: acl acl injuries acl reconstruction let osteoarthritis knee osteoarthritis orthopaedics anterolateral ligament lateral extra-articular tenodesis (let)
a 7-day cross-over study of qd (once daily) and bid (twice daily) td-4208 in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease; COPD

Summary: this study evaluated the safety and efficacy of once and twice daily td-4208 and placebo when administered using a jet nebulizer for 7 days in a cross-over design to patients with moderate to severe chronic obstructive pulmonary disease.


Eligibility criteria:
inclusion criteria: * subject must have a negative pregnancy test, and must be prepared to use effective contraception if of child-bearing potential * subject is capable of performing reproducible spirometry maneuvers * subject has post-bronchodilator fev1/fvc (forced expiratory volume in 1 second/forced vital capacity) ratio \<0.7 * subject has moderate-to-severe stable copd (stage 2 or 3 according to the global initiative for the treatment of obstructive lung disease (gold) guidelines) * subject has a post-bronchodilator fev1 greater than or equal to 30% and less than 80% of predicted normal * subject demonstrates a post-ipratropium fev1 response ≥ 12% and ≥ 200 ml of pre-ipratropium fev1 response * subject has a current or past smoking history of at least 10 pack-years. exclusion criteria: * subject has a significant respiratory disease or disorder other than copd that would affect the interpretation of data from this study * subject has a history of reactions or hypersensitivity to inhaled anticholinergic or beta-agonist agents * subject suffers from any medical condition that would preclude the use of inhaled anticholinergic agents * subject has been hospitalized for copd or pneumonia within 12 weeks. * subject requires long-term oxygen therapy (\>15 hours a day)

Keywords: chronic obstructive pulmonary disease copd
trial evaluating combined chemotherapy in patients with metastatic pancreatic adenocarcinoma

Conditions: Metastatic Pancreatic Adenocarcinoma

Summary: gate 1 is an open-label, non-comparative, multicentric study evaluating the efficacy and tolerance of the combined use of gemcitabine, trastuzumab and erlotinib as a first-line chemotherapy in metastatic pancreatic cancer patients. the patients will be treated intravenously with gemcitabine at a dose of 1000 mg/m2 for 30 min. for the first eight weeks, gemcitabine will be administered once weekly for 7 weeks followed by one week of rest. subsequently, gemcitabine will be administered once weekly for three weeks followed by one week of rest. trastuzumab will be administered once a week at a dose of 4 mg/kg over 90 min. at d1 and then at 2 mg/kg over 30 min. for the subsequent infusions. erlotinib will be administered orally at a dose of 100 mg/day from c1d1. the patients will be subjected to research for the egfr, her2 and kras status.


Eligibility criteria:
inclusion criteria: * metastatic pancreatic adenocarcinoma confirmed by histology * tumor sample available * measurable lesion according to recist criteria * performance status ≥ 1 * life expectancy \> 3 months * hematology: hb ≥ 9g/dl, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3 * renal function: creatinine ≤ 1.5 x uln * hepatic function: total bilirubin ≤ 2.5 x uln, transaminases ≤ 5 x uln * left ventricular ejection fraction (lvef) ≥ 50% * at least a 6-month delay between the end of any previous gemcitabine-based chemotherapy and diagnosis of metastases * social security * informed consent obtained prior to inclusion. exclusion criteria: * non metastatic advanced local disease * presence of cerebral metastases or symptomatic leptomeningeal carcinomatosis * others cancers except bbc and cervical cancer receiving curative treatment * no previous treatment by erlotinib or trastuzumab * known severe hypersensitivity to erlotinib, trastuzumab, murine proteins or gemcitabine * presence of significant co-morbidities * concomitant treatment with other experimental products or other anticancer therapies * breastfeeding or pregnant female, or patient of reproductive age not using adequate contraception * legal incapacity or limited legal incapacity

Keywords: metastatic pancreatic adenocarcinoma first-line chemotherapy combination chemotherapy targeted agents
serum ferritin as a non-invasive marker in prediction of hepatic fibrosis among nafld patients

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: this study was designed to assess the relation between serum ferritin and hepatic fibrosis in patients with nafld. it included 83 patients with nafld with or without hepatic fibrosis, in addition to 30 healthy subjects included as controls. measurement of serum ferritin and its correlation with steatosis and fibrosis was done.

background: many studies have found a relationship between hepatic iron, serum ferritin and nafld or its progress. aim of the work: is to assess the value of serum ferritin as a non-invasive marker in prediction of hepatic fibrosis in nafld. methods: this study included 113 subjects who were classified into 3 groups. group i: included 30 healthy subjects as control with no evidence of nafld by liver biopsy. group ii: included 31 nafld patients without fibrosis proved by liver biopsy. group iii: included 52 patients with hepatic fibrosis on top of nafld proved by liver biopsy. serum ferritin was determined using ferritin elisa kit. fib4 was calculated and liver biopsy was done for all patients.

Eligibility criteria:
inclusion criteria: * adult patients with nafld with or without hepatic fibrosis exclusion criteria: * significant alcohol consumption, other causes of liver disease such as viral hepatitis, schistosomiasis, autoimmune, hereditary, drug induced, or decompensated liver cirrhosis.
emotion regulation and binge eating in youth with obesity

Conditions: Obesity; Binge-Eating Disorder

Summary: this study will investigate neural activation patterns in emotion- and cognition-related brain regions during an emotion regulation task involving cognitive reappraisal, and their associations with age and pubertal status, among overweight children and adolescents with loss of control eating as compared to overweight and normal-weight controls.

loss of control (loc) while eating (i.e., the sense that one cannot control what or how much one is eating) is prevalent among children and adolescents. loc eating is associated with a range of physical and psychosocial health impairments, including obesity and the development of partial- and full-syndrome eating disorders. early identification is thus critical for preventing or minimizing these adverse health outcomes. however, little is known about the development of loc eating in children and, consequently, there is a paucity of effective interventions. impairments in emotion regulation appear to be involved in the onset and maintenance of eating pathology in obese samples. to date, emotion regulation in youth with loc eating problems is poorly understood, and research on underlying neurodevelopmental substrates is virtually nonexistent. the proposed research aims to characterize neurocircuitry involved in emotion regulation among 30 overweight children with loc eating as compared to 30 overweight and 15 normal-weight controls without loc. participants will complete a cognitive reappraisal task whilst situated in an mri scanner, the purpose of which is to characterize neural activity involved in reappraisal versus an emotion maintenance control condition. the proposed research aims to advance the field's understanding of the nature and correlates of loc eating in overweight children so as to inform intervention development.

Eligibility criteria:
inclusion criteria: * right-handed, aged 10-17 years. exclusion criteria: participants will be excluded if they * are currently taking any medications known to affect mood or weight (e.g., antidepressants, steroids); * have a current diagnosis of a mood disorder or an eating disorder involving purging or suppressed body weight (e.g., bulimia nervosa or anorexia nervosa); * are unable to read and understand english fluently; * are currently pregnant; * are a current smoker; or * have metallic foreign bodies, face or neck tattoos, or other conditions that would prohibit fmri scanning. participants will complete a mock scan (see below) to ensure that their head and trunk size can be comfortably accommodated in the scanner.