Kornimate/medical-research-clean huggingface dataset:
neurobiological substrate of social context on cognitive control in drug users

Conditions: Drug Use

Summary: the aim of the present project is to reveal, using functional magnetic resonance imaging (fmri) in drug users, a specific modulation of brain structures and circuits involved in cognitive control (and especially those of inhibitory control) and reward while subjects are performing under the influence of drug-associated cues and in various social contexts. this hypothesis, based on the animal work, is that the subthalamic nucleus (stn) should play a critical role in these processes. addictive behaviour can be seen as a loss of control resulting from reduced inhibitory control, leading to compulsive drug use. these disorders are known to be associated with a hypoactivation of specific frontal regions such as the anterior cingulate cortex or the prefrontal cortex. for the present experiment, it is chosen to use a procedure well established for neurophysiological and behavioural assessment of inhibitory processes : the " stop-signal reaction time task ". this task requires to inhibit a motor response (press a button) at the onset of a stop signal (a tone) that occurs while the response is already engaged. in this task associated with fmri, it was previously shown that the stn is involved in the control of inhibition. these results confirm our data in the rat, and especially those showing that stn lesions block the ability to stop. the stop signal task will thus be appropriate to study the effect of the social context on inhibitory processes in a population of cocaine users. in cocaine abusers, it was shown that inhibitory processes are affected. here we aim at testing this population of subjects while they perform the stop task, but adding an implicit cognitive load induced by visual cues associated or not with cocaine intake. since it want to assess the influence of a peer on both the performance and the associated cerebral activities, it will also control the presence of a peer observer in the procedure. there will thus be three experimental factors, one inter-subject factor (the experimental group, cocaine users or controls) and two intra-subject factors (cocaine associated or neutral cue; presence of a peer observer). the "stop-signal" task should induce increased activity of the stn that should be modulated by the cocaine-associated cues and by the presence of a peer.


Eligibility criteria:
inclusion criteria: drug users group * age between 18 and 65 years * regular use of cocaine and crack * willing to participate * able to give consent * not meeting any non-inclusion criteria * right-handed healthy volunteers group * age between 18 and 65 years * non-drug user * willing to participate * able to give consent * not meeting any non-inclusion criteria * right-handed exclusion criteria: * protected persons * lactating women * intolerance to noise * not a beneficiary of a social security scheme. * no signature on the consent form * significant psychiatric or neurological disorder * known visual impairment and abnormal vision despite correction * contraindication to mri examination * claustrophobia. * pregnant women
safety & efficacy of epo-018b for the treatment of anemia in participants with chronic kidney diseases not on dialysis

Conditions: Chronic Renal Failure; Chronic Kidney Disease; Anemia

Summary: the purpose of this study is to evaluate the safety,efficacy， pharmacodynamics (pd), and pharmacokinetics (pk) of multiple intravenous doses of epo-018b in participants with chronic kidney disease (ckd) who are not on dialysis


Eligibility criteria:
inclusion criteria: 1. males or females ≥18 and≤70. 2. chronic renal diseases stage 3 or 4 (estimated glomerular filtration rate (egfr) between 15 and 60 ml/min per 1.73 m2 using the ckd-epi equation) and no expected need for dialysis during the study. 3. patients who have not received any erythropoietic agents within 6 weeks prior to the first study dose. 4. two hemoglobin values of ≥ 6.0 and \< 10.0 g/dl at screening 5. patients with a transferrin saturation ≥ 20% or a ferritin ≥ 100 ng/ml. vitamin b12 and folic acid level above lower limit of normal. 6. signed informed consent. exclusion criteria: 1. pregnant or lactating females. 2. red blood cell transfusion within 3 months prior to study drug administration. 3. known intolerance to any erythropoiesis stimulating agent (esa) or pegylated molecule or to all parenteral iron supplementation products . 4. hemolytic syndromes or coagulation disorder. 5. hematological disease (including but not limited to myelodysplastic syndrome, hematological malignancy, hemoglobinopathy, pure red cell aplasia). 6. chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.). 7. c reactive protein (crp)level greater than 30 mg/l within the 4 weeks prior to study drug administration. 8. uncontrolled or symptomatic secondary hyperparathyroidism(ipth\>500pg/ml). 9. poorly controlled hypertension within 2 weeks prior to study drug administration, per investigator's clinical judgment (e.g. systolic ≥ 160mm hg, diastolic ≥ 100 mm hg) 10. chronic congestive heart failure (new york heart association class iv). 11. significant symptom within 6 months prior to study drug administration (e.g. myocardial infarction, serious or precarious coronary artery disease,stroke, respiratory disease, autoimmune disease, neuropathy, phrenopathy, hepatopathy including active hepatitis b, active hepatitis c, or alt\> 3 x upper limit of normal (uln), ast\> 3 x upper limit of normal (uln), etc.). 12. a positive test for hiv antibody. 13. tumor malignancy. 14. expected survival less than 12 months. 15. major surgery (may massive bleeding) during the study. 16. expected conception within 4 weeks after the end of the study treatment. 17. the subject has participated in other clinical trial within the 6 weeks prior to study drug administration. 18. have any other condition or prior therapy that, in the investigator's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures.
rct for women with a persisting pregnancy of unknown location

Conditions: Persistent Pregnancy of Unknown Location; Ectopic Pregnancy

Summary: this is a randomized controlled trial to compare three currently available management strategies for women with a persisting pregnancy of unknown location (ppul), which makes them at-risk for ectopic pregnancy. we will recruit hemodynamically stable women with a confirmed ppul to be randomized to one of three strategies: 1) uterine evacuation followed by methotrexate (mtx) for some (those that have evidence of a non visualized ectopic pregnancy) 2) empiric treatment with mtx for all, and 3) expectant management. randomization will be 2:2:1 into these three arms. after randomization, they will be followed and treated clinically as is indicated by the progression of their condition. primary outcome measures: uneventful decline of hcg to 5 iu/ml. secondary outcome measures: re-interventions, treatment complications, health-related quality of life, financial costs, future fertility, and patient's preferences.


Eligibility criteria:
inclusion criteria: 1. female with a persisting pregnancy of unknown location: 1. a pregnancy of unknown location is defined as a women with a positive pregnancy test but no definitive signs of pregnancy in the uterus or adnexa on ultrasound imaging (ultrasound must be performed within 7 days prior to randomization) 2. persistence of hcg is defined as 3 serial hcg values over 4-14 days or 2 serial hcg values over 7-14 days, showing less than 30% rise, or less than 30% fall between the first and last value. (this abnormal pattern of serial hcg confirms that the gestation is nonviable.) 2. patient is hemodynamically stable, hemoglobin greater than 10 mg/dl, 3. greater than or 18 years of age exclusion criteria: 1. hemodynamically unstable in need of acute treatment 2. most recent hcg greater than 5000 iu/ml 3. patient obtaining care in relation to a recently completed pregnancy (delivery, spontaneous or elective abortion), 4. diagnosis of gestational trophoblastic disease, 5. subject unwilling or unable to comply with study procedures, 6. presence of clinical contraindications for treatment with methotrexate (acog guidelines, appendix b), 7. prior medical or surgical management of this gestation.
use of thermography for the prevention and diagnosis of diabetic foot

Conditions: Diabetic Foot; Diabetic Neuropathies; Diabetic Angiopathy

Summary: diabetic foot is a serious complication of diabetes mellitus that can lead to ulcerations, infections and, in extreme cases, amputations. early detection of changes in skin temperature can help prevent these complications. infrared thermography is a noninvasive technique that allows the visualization and quantification of skin temperature and could be an effective tool for the early detection of alterations in diabetic foot. objective to evaluate the effectiveness of infrared thermography in the early detection and diagnosis of diabetic foot, comparing the temperatures of the feet of healthy subjects and subjects with diabetic foot.

significant differences in foot temperatures are expected to be found between subjects with diabetic foot and healthy subjects. it is anticipated that areas of the foot at higher risk of ulceration in subjects with diabetic foot will show higher temperatures due to inflammation and changes in blood perfusion. the results of the study could validate the use of thermography as an early detection and monitoring tool in patients at risk of developing diabetic foot. this could allow early and personalized interventions to prevent serious complications.

Eligibility criteria:
inclusion criteria: subjects of both sexes. age between 40 and 80 years. diagnosis of type 1 or type 2 diabetes mellitus (for the case group). absence of acute inflammatory diseases in the control group. signed informed consent. exclusion criteria: skin diseases that affect the interpretation of thermography. recent treatment with medications that affect peripheral circulation. history of lower limb amputation.

Keywords: diabetic foot neuropaty angiopaty termography
the use of post-operative npwt dressing in the prevention of infectious complications after ostomy reversal surgery

Conditions: Stoma Ileostomy; Surgical Wound; Negative Pressure Wound Therapy; Postoperative Wound Infection

Summary: introduction: although negative-pressure wound therapy (npwt) is likely advantageous for wound healing, the efficacy and safety of its prophylactic use remain unclear. we performed a randomized control trial to assess the usefulness of postoperative npwt in reduction of postoperative wound healing complications and surgical site infections after diverting ileostomy closure, in the group of patients previously operated for colorectal resection due to cancer. materials \& methods: prospective, randomized study will be conducted. patients with past history of colorectal cancer laparoscopic surgery with protective loop ileostomy scheduled to undergo ileostomy closure with primary wound closure will be randomly divided into groups with or without npwt. the primary endpoint are incidence of wound related complications (wrc) (wound healing complications witch required surgical intervention other than suture removal or dressing changing). the secondary endpoints are incidences of surgical site infection (ssi) and length of postoperative hospital stay (los) and length of complete wound healing (cwh). cost analysis will also be performed. in first step of this study between january 2016 and december 2018 we will asses the usefulness of one of the npwt devices (nanova kci) in prevention of whc in established group. the second part of the study will be performed in 2 centers between january 2019 and december 2021. in this step we want to compere other npwt devices in the same application and to confirm single center outcomes .


Eligibility criteria:
inclusion criteria: * patients aged 18 or older * previous colorectal resection with the formation of protective ileostomy due to cancer * ileostomy closure surgery as an elective procedure. exclusion criteria: * emergency or urgent operation * active infection * other than ileostomy closure or parastomal hernioplasty operation performed. * patents who within 1 week after operation will be re-operated or transferred to intensive care unit or other hospital word due to noninfectious complications
effect of inflammation on voriconazole concentration

Conditions: Inflammation; Fungal Infection

Summary: voriconazole is a broad-spectrum antifungal agent. there is evidence for a relation between the efficacy and safety of voriconazole and voriconazole trough concentrations. there are several factors that could influence voriconazole concentrations. inflammation could be one of these factors. in a retrospective study was observed that reduced metabolism of voriconazole was related to inflammation in patients with severe infections. reduced metabolism of voriconazole resulted in high voriconazole levels and low n-oxide metabolite (inactive metabolite of voriconazole) levels. the purpose of this study is to determine an algorithm to guide dosing of voriconazole during severe inflammation and to develop a multiple linear regression model to describe the contribution of crp concentrations to the variability in voriconazole levels and metabolic ratio.


Eligibility criteria:
inclusion criteria: * age ≥ 18 yrs * treatment with voriconazole * written informed consent exclusion criteria: * concomitantly using a strong inhibitor or inducer of cyp p450

Keywords: voriconazole crp inflammation pharmacokinetics
a clinical trial to evaluate the efficacy of the morley medical sepsis (mms) software device in predicting sepsis in adult patients using artificial intelligence (ai) machine learning algorithms

Conditions: Sepsis

Summary: this is a pivotal medical device clinical trial evaluating the clinical outcomes in hospitalized patients monitored with the morley medical sepsis software device. the device uses unique ai machine learning algorithms to analyze patient data in real time and generate clinical decision support sepsis risk predictions for clinicians.


Eligibility criteria:
inclusion criteria: * male or female patient 18 years of age or older * patient is admitted or had been admitted to a participating healthcare facility exclusion criteria: * sepsis diagnosis present on admission * involvement in a clinical trial of another investigational product with similar purpose
randomized clinical trial of propofol, 1:1 and 4:1 combination of propofol and ketamine for procedural sedation

Conditions: Procedural Sedation

Summary: this will be a randomized trial of propofol versus the combination of propofol and ketamine for procedural sedation for procedures in the emergency department (ed). propofol produces sedation, hypnosis, and dense amnesia, and is commonly used in the ed at hennepin county medical center (hcmc) for procedural sedation. ketamine is a dissociative anesthetic that is also frequently used in the ed in children and sometimes in adults. it has been proposed that by combining the two agents, the negative side effects of respiratory depression and hypotension associated with propofol, and the negative effects of dysphoria and vomiting associated with ketamine, can be avoided. in the proposed study, patients seen in the ed who will require procedural sedation for a painful procedure will be randomized to receive either propofol or propofol and ketamine. during the procedure, patients will be monitored per the standard of care, including use of a cardiac monitor, non-invasive blood pressure monitoring, pulse oximetry, nasal sample end-tidal carbon dioxide, and physician assessment. once the procedure is successfully completed and the patient has returned to his/her baseline mental status, the patient will be asked to mark a 100 mm visual analog scale regarding perceived pain during the procedure, memory of the procedure, and overall satisfaction with the procedure.


Eligibility criteria:
inclusion criteria: * adult patients undergoing procedural sedation for an urgent procedure in the emergency department exclusion criteria: * allergy to propofol or ketamine, intoxication, altered mental status, asa physical status score \>2

Keywords: deep procedural sedation propofol ketamine emergency department monitoring capnography procedural sedation in the emergency department
efficacy of digital cognitive behavioral therapy for insomnia (cbt-i)

Conditions: Insomnia

Summary: insomnia is a common sleep problem, which affects 9.4-38.2% of youths worldwide. youth insomnia is linked to mental health problems, leading to substantial health and economic burden. the project aims to conduct an assessor-blind, randomized controlled trial to evaluate the efficacy of an app-based cbt-i with ai chatbot in reducing insomnia symptoms among youths, compared to an app-based cbt-i without ai chatbot.


Eligibility criteria:
inclusion criteria: i. youth aged 18 to 25 years (as defined by who and evidence on ai mental health chatbots only available for individuals aged 18 years and older) ii. online informed consent of participation in the study should be provided iii. willing to comply with the requirements of the study protocol iv. the presence of moderate to severe insomnia measured by a score of 15 or above on the insomnia severity index (isi) v. difficulties initiating, maintaining or nonrestorative sleep over a 1-month period vi. having access to a smartphone and consistent internet access for their smartphone vii. accepting the terms of service and privacy policies of the mobile apps used in the study for the delivery of the intervention exclusion criteria: i. a history of any sleep disorder(s) (other than insomnia disorder) such as narcolepsy, obstructive sleep apnea, and restless legs syndrome ii. a history of any mental retardation or neuropsychiatric disorder(s) (other than depression and anxiety disorders as they are the secondary outcomes) such as bipolar disorder, schizophrenia, and substance use disorder iii. presence of serious suicidality as evidenced by ideation with a plan or an attempt iv. receiving any pharmacological treatment (including sleep promoting agents) v. receiving any structured psychotherapy vi. having shiftwork and trans-meridian travel in the past 3 months and during the intervention
simplified isoniazid preventive therapy strategy to reduce tb burden

Conditions: Tuberculosis; HIV/AIDS

Summary: the overall objective of this study is to determine if a multi-component implementation intervention (spirit) and additional leadership and management training that targets district health officers (dhos) can increase ipt initiation among hiv-infected persons, as compared to country standard practices, in a cluster randomized trial in uganda.

the failure to use isoniazid (inh) preventative therapy (ipt) in hiv-infected individuals in sub-saharan africa represents one of the single biggest implementation gaps between evidence and practice in today's response to the hiv epidemic. the proposed study will evaluate the effectiveness of a multi-component intervention to improve ipt uptake in two regions of uganda. the study design is a randomized controlled trial (rct) where the unit of randomization is clusters of districts in uganda. the clusters consist of 5-7 districts and the district health officer (dho) and district tb and leprosy supervisor (dtls) from each district is invited to participate. the spirit intervention is based on the precede framework which outlines the importance of social networks, social influence, and behavior change. the search-ipt multi-component intervention includes: * a teaching collaborative which will be formed within the randomized clusters of district dhos and dtlss to create a mini-collaborative, which will be led by an opinion leader with hiv and tb expertise, to spread new scientific knowledge about ipt and the clinical ability to rule out tb, and to facilitate discussion between dhos. * a "toolkit" of options to ease ipt implementation will support dhos to scale up ipt through the study of the comparative effectiveness of material contributions to their day-to-day function of managing front line providers and clinics. * a reporting collaborative comprised of the teaching collaborative groups, will define targets as a group, and reconvening every 6 months for 3 years (with the additional option of 36 months for a final report back), where each collaborative has an opportunity to share progress and results. in addition, an enhanced business training \& 'training-of-trainers' curriculum will be conducted to evaluate the effect of enhanced business training among intervention group dhos from phase 1 (years 1-3 of trial follow-up) in the southwestern uganda region on ipt initiation during years 4-5 of trial follow-up (phase 2).

Eligibility criteria:
aim 1 - spirit intervention: inclusion criteria: * district health officer or tb district supervisor (or other dho-appointed tb focal person) in uganda. * by definition, the dho or tb district supervisor are all ≥18 years of age. exclusion criteria: * planned departure from position as dho or tb district supervisor prior to randomization. * dhos from kampala and wakiso districts, uganda.
pilot testing of a behavioral intervention for chronic pain in individuals with hiv

Conditions: Chronic Pain

Summary: due to its specific pathophysiology and impact on health outcomes, the institute of medicine has described chronic pain as a complex chronic disease and a "national public health crisis." the unique neurobiological basis and psychosocial context of chronic pain in hiv-infected patients underscores the importance of developing and testing a behavioral intervention specifically tailored to this population. this study will pilot test a newly-developed behavioral intervention for chronic pain tailored to individuals with hiv.

chronic pain is a chronic condition with a unique neurobiologic basis, which has a substantial impact on physical and emotional function. chronic pain in hiv-infected patients is common, and associated with serious health consequences, including up to 10 times greater odds of impaired physical function. many pharmacologic therapies, including opioids, often do not lead to improved pain and function, and carry significant risk. evidence-based behavioral interventions are among the most effective and safe non-pharmacologic chronic pain treatments investigated in the general medical population. therefore, behavioral interventions to improve pain, physical, and emotional function in hiv-infected patients are needed. there is much to be learned from existing interventions. however, the success of a behavioral intervention is heavily influenced by how well it is tailored to the target population's biological, psychological, and social environment. therefore, in this study investigators will conduct a two-arm pilot randomized controlled trial of a recently-developed behavioral intervention compared to routine hiv and pain care, to determine feasibility, acceptability, and preliminary impact.

Eligibility criteria:
inclusion criteria: 1. enrolled in the center for aids research network of integrated clinical systems (cnics) cohort 2. age ≥ 18 years 3. chronic pain (brief chronic pain screening questionnaire (bcpq) = at least moderate pain for at least 3 months) 4. moderately severe and impairing chronic pain (peg pain questionnaire = average of all three times is 4 or greater) exclusion criteria: 1. do not speak or understand english 2. are planning a new pain treatment like surgery 3. cannot attend the group sessions.