Kornimate/medical-research-clean huggingface dataset:
feasibility and acceptability of digital pills to monitor prep adherence in msm with substance use

Conditions: HIV/AIDS; Substance Use Disorders; Adherence, Medication

Summary: this study deploys a novel digital pill with emtricitabine/tenofovir (tdf/ftc) among msm with substance use to monitor prep adherence. the investigators will enroll n=15 hiv uninfected msm with self reported substance use who are on prep or initiating prep to use digital pills over encapsulating tdf/ftc for 3 months. the investigators will assess the feasibility of using digital pills in this study population as well as understand the acceptability of digital pills for adherence measurement using semi-structured individual interviews. additionally, the investigators will measure adherence over time, as well as episodes of suboptimal prep adherence.

eligible study participants will be screened and enrolled at fenway health (boston, ma). participants will complete a quantitative assessment on their history fo substance use, sexual risk and prep adherence, and be trained to use the digital pill for 90 days and instructed to take prep daily during the course of the study. participants will return each month for a study visit to assess their use of the technology. at study visit 1 and 3, we will obtain dried blood spots (dbs) to measure drug levels and to confirm adherence detected by the digital pill. the investigators will also obtain drugs of abuse screens from dbs. at the final study visit (3 months), participants will undergo a semi-structured qualitative interview to understand the user response to digital pills.

Eligibility criteria:
inclusion criteria: 1. msm (cisgender male) 2. self-reported use of non-alcohol substances of abuse in past 6 months 3. currently taking prep 4. has qualifying laboratory tests (cr, hepatitis b immunization, sti testing and syphilis) 5. age 18 or older exclusion criteria: 1. does not speak english 2. hiv positive 3. identifies as transgender 4. estimated creatinine clearance \<60ml/min 5. active hepatitis b treatment 6. does not own a smartphone 7. taking proton pump inhibitors 8. history of crohn's disease or ulcerative colitis 9. history of bowel surgery, gastric bypass, bowel stricture 10. history of gi malignancy or radiation to abdomen 11. unable/unwilling to ingest digital pill

Keywords: prep substance use disorder digital pills medication adherence
optimizing pain and rehabilitation after knee arthroplasty

Conditions: Total Knee Arthroplasty

Summary: the aim of this study is to determine the best method of pain control that will help with rehabilitation after total knee arthroplasty (tka). currently, the best method for pain control after tka appears to be continuous femoral nerve block (fnb) where a small tube is placed beside the nerve that provides sensation to a large part of the knee and local anesthetic infused after surgery causing numbness to the surgical site. a single injection method also exists and may provide similar benefits. both methods require training and can result in side effects such as temporary weakness (while the local anesthetic is still working) that can inhibit rehabilitation. a newer method injecting local anesthetic into the joint after surgery (local infiltration analgesia (lia)) is becoming common, does not cause weakness and can be done quickly at the end of surgery. it is unknown if the pain control provided by lia is as good as that of fnb. this study will compare the femoral nerve block, continuous femoral nerve block and lia technique to determine which provides better pain relief after tka.

this will be a prospective, randomized, double blind study. patients will be randomized using a computer-generated sequence to one of three groups: group 1: continuous femoral nerve block group (cfnb) group 2: single injection femoral nerve block group (sfnb) group 3: local infiltration analgesia group (lia) inclusion criteria: patients between the ages of 18 and 85 having primary tri-compartmental total knee arthroplasty. exclusion criteria: allergy, intolerance, or contraindication to any study medication (see below), inability to walk independently prior to tka, inability to comprehend french or english, use of major tranquilizers, asa 4 or 5, bmi \> 40, opioid tolerance (opioid consumption \> 30mg oral morphine or equivalent per day), pregnancy

Eligibility criteria:
inclusion criteria: * adults undergoing primary, tri-compartmental knee arthroplasty exclusion criteria: * allergy, intolerance, or contraindication to any study medication * inability to walk independently prior to tka * inability to comprehend french or english * use of major tranquilizers * asa 4 or 5 * bmi \> 40 * opioid tolerance (opioid consumption \> 30mg oral morphine or equivalent per day) * pregnancy
stress intervention for chronic urticaria

Conditions: Chronic Urticaria

Summary: stress and chronic urticaria has been linked. the purpose of the study is to evaluate a patients chronic urticaria and stress levels before and after he/she goes through six sessions designed to help that participant manage his/her stress.

the purpose of this single-arm, interventional pilot study is to evaluate the effect of psychological stress intervention for patients with chronic urticaria, as many of these patients report heightened levels of stress before and/or after the onset of the urticaria. participants will meet individually with a university of mississippi medical center psychiatry resident for one hour once a week for six consecutive weeks to be educated on psychological stress intervention techniques. there is no control group for this pilot study. all participants will complete a packet of psychological and dermatological questionnaires before the first session with the psychiatry resident and one week after the final session. all participants will record daily 1) their urticaria symptoms and 2) the type and number of medications taken for his/her chronic hives. if psychological stress intervention proves to be effective, then this therapeutic modality would benefit patients with chronic urticaria, while avoiding addition and/or continuation of medications that may have significant adverse side effects.

Eligibility criteria:
inclusion criteria: * males and females age 18-64 years old who have had hives for longer than 6 weeks. * hives persist despite medical therapy. * minimum urticaria activity score of 2 (one point from each of the two categories: number of hives and severity of pruritus). exclusion criteria: * urticaria secondary to vasculitis. * urticaria as part of an anaphylactic response. * use of omalizumab within 3 months preceding enrollment period.

Keywords: urticaria hives stress
closure of atrial septal defects with the amplatzer septal occluder - post approval study

Conditions: Atrial Septal Defect

Summary: the purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the amplatzer septal occluder


Eligibility criteria:
inclusion criteria: * patients must meet all inclusion criteria. a patient meets inclusion criteria if he/she: * is indicated for implantation with the amplatzer septal occluder for occlusion of a secundum atrial septal defect (note: this does not include the indication for closure of a fenestration following a fenestrated fontan procedure), * is willing and able to complete the follow-up requirements of this study, and * signs the informed consent (or a legal representative signs the informed consent).

Keywords: atrial septal defect
the study of immune cell (t cell) activity in patients with paraneoplastic neurologic syndromes

Conditions: Paraneoplastic Syndromes

Summary: the investigators believe that t cells, cells that are a part of the immune system, are what are causing the neurological problems while also attacking tumor cells. this protocol studies the clinical status of patients with paraneoplastic neurological disorder (pnd) as well as their blood to understand the relationship between their neurological disease, their cancer, and their immune system.

patients with paraneoplastic neurological disorders (pnds) provide a unique model for studying tumor immunity and neuronal autoimmunity. we hypothesize that t lymphocyte autoimmune dysfunction is involved in the pathogenesis of the paraneoplastic neurological syndromes, and that killer t cells are involved in the targeting and successful killing of tumor cells in these cancer patients. furthermore, we postulate that this activity may provide a model for autoimmune brain disease. we will assess the immune responses in pnd patients, correlate these with the clinical data (time course of disease, symptoms and signs, disability), and collect and archive clinical data, serum and cells from pnd patients for current and future studies into the basic immune system phenomenon present in pnd patients.

Eligibility criteria:
inclusion criteria: * neurological disease which is suspected to be paraneoplastic * no known active additional malignancy other than non-melanoma skin cancer exclusion criteria: * known central nervous system (cns) metastasis * known active additional malignancy * no pulmonary disease which limits daily activities if leukapheresis: must be 14 or older no known hepatitis b or c, hiv, or syphilis (by history or prior negative tests) no known iv drug users hgb \> 8.5 wbc \> 3,500 platelets \> 100,000 inr \< 2 if large blood draw (1/2 to 1 unit; children 3 ml/kg) in lieu of leukapheresis: no known iv drug users hgb \> 10 wbc \> 3,500 platelets \> 100,000 inr \< 2 if lumbar puncture: platelets \> 120,000 inr \< 1.2 must be 14 or older

Keywords: paraneoplastic neurologic syndromes
proteiomic fingerprints of gastric juice

Conditions: Gastric Cancer

Summary: no accurate, inexpensive and non-invasive test for gastric cancer screening is currently available. the investigators' recent study identified a1-antitrypsin and other proteins as potential biomarkers of gastric cancer in gastric juice. the aim of this study was to develop a novel non-invasive modality for detecting gastric cancer by measurement of biomarkers in gastric juice.

patients and methods: the study consisted of two parts: (1) investigating the differences in gastric juice biomarker concentrations between gastric cancer patients and controls, and (2) screening gastric cancer using string test to obtain gastric juice followed by immunoassay for biomarker concentration.

Eligibility criteria:
inclusion criteria: * healthy subjects and gastric cancer patients documented by endoscopy. exclusion criteria: * the use of proton pump inhibitors or histamine-2 receptor antagonists within 4 weeks prior to the study * coexistence of two kinds of gastroduodenal lesions * coexistence of severe systemic diseases

Keywords: gastric cancer proteomics gastric juice
risk factors and prognosis of adverse cardiovascular and kidney events after coronary intervention

Conditions: Cardio-Renal Syndrome; Coronary Angiography; Coronary Artery Disease; Kidney Diseases; Metabolic Syndrome

Summary: as a single center, retrospective observation study in guangdong institute of cardiovascular diseases, this study included the main study population of patients who underwent coronary angiography and / or coronary intervention from january 2007 to decemeber 2018. the hospitalization information was collected in the form of direct derivation of the case, and cardiac and renal adverse events were collected through outpatient recorder system. all-cause death information was obtained from the public security and matched to the electronic clinical management system of the guangdong provincial people's hospital records.

this is a single center, retrospective observation study collecting data on 88938 coronary angiography and / or coronary intervention patients from january 2007 to decemeber 2018. data regarding demographic information, admission diagnoses and history of present illness, biomarkers and details on preventive hydration and medications will be collected. the primary endpoint of this study is all-cause mortality, and secondary endpoints are adverse cardiovascular and kidney events.

Eligibility criteria:
inclusion criteria: 1. patients referred to cag or pci; exclusion criteria: -

Keywords: contrast-induced acute kidney injury contrast medium creatinine clearance coronary angiography chronic kidney disease adverse cardiovascular and kidney events
evaluation of impact of sandostatin® injection before axillary clearance on lymphocele formation

Conditions: Breast Cancer; Lymphocele

Summary: the lymphocele is the main early postoperative complication of axillary clearance for breast cancer patients with rates up to 85%. the usual treatment consists of external drainage. however, this method increases the duration of hospitalization. as a result, some practitioners have abandoned drainage, allowing for ambulatory surgery. if this solution makes it possible to reduce the duration of the hospitalizations, it involves iterative punctures of the axillary hollow in case of lymphocele these punctures may be responsible for pain, hematoma or infection of the operative site. to date, no method has proved superior in terms of decreasing the incidence of lymphocele postoperatively axillary clearance. octreotide (sandostatin®) is a peptide, one of whose effects is to reduce the inflammation responsible for lymphoceles. the aim of the study is to inject sandostatin® before surgery, with the aim of reducing the incidence of seroma by 50% after axillary clearance


Eligibility criteria:
inclusion criteria: breast cancer, histologically proven axillary clearance elective axillary approach age ≥ 18 years oms \< 3 normal hematological and hepatic blood tests obtaining the signed written consent of the patient exclusion criteria: axillary clearance with a mastectomy metastatic disease disorder precluding understanding of trial information or informed consent pregnancy, breastfeeding women patient is willing and able to comply with the protocol for the duration of the study including all scheduled treatment, visits and examinations no severe or uncontrolled diabetes known hypersensitivity to octreotide patient with vitamin b12 deficiency anticoagulant treatment history of cardiovascular disease other product being tested in the 4 weeks prior to the start of treatment patient has valid health insurance

Keywords: breast cancer axillary clearance lymphocele
study of anatomic nerve sparing radical perineal prostatectomy

Conditions: Prostate Cancer

Summary: our objective is to evaluate the clinical outcomes for the anatomic radical perineal prostatectomy (rpp) for the surgical management of prostate cancer. we will report the perioperative, oncologic, and functional outcomes in patients undergoing the radical perineal prostatectomy at our institution.

the purpose of our study is to evaluate perioperative, oncologic, and functional outcomes for the anatomic radical perineal prostatectomy. the anatomic radical perineal prostatectomy is standard-of-care surgical approach to the surgical management of localized prostate cancer. the operative technique selected for radical prostatectomy is largely based on patient preference after appropriate counseling, and surgeon recommendation based on surgical considerations and surgeon experience. outcome data for the anatomic radical perineal prostatectomy will represent a valuable addition to the published body of literature. our study is a prospective clinical outcome data collection and analysis and we will be looking at data within several domains. first, perioperative data will be collected to evaluate the or time, blood loss, surgical complications, and length of hospital stay for the anatomic radical perineal prostatectomy. second, oncologic efficacy of this procedure will be reported, based on margin status of surgical specimens, which will be correlated with tumor features (gleason score, tumor volume, pre-op psa score). third, functional outcomes will be evaluated by comparing urinary, sexual, and bowel function in the pre-op and post-op settings. this third domain will be accomplished by employing the following validated questionnaires (attached - shim, ipss, and epic-26). these questionnaires will be filled out at 3 time-points: pre-op, and at 3 months and 12 months post-operatively.

Eligibility criteria:
inclusion criteria: * 18 years of age * perineal prostatectomy for prostate cancer at maimonides medical center exclusion criteria: * dementia

Keywords: perineal prostatectomy nerve anatomic surgery neoplasms, prostatic prostate cancer prostate neoplasms prostatic cancer prostate cancer recurrent
im olanzapine versus haloperidol or midazolam

Conditions: Acute Agitation, Behavioural Emergency

Summary: the purpose of this study is to determine whether intramuscular olanzapine is safer (fewer adverse events) and more effective (shorter time to sedation) than conventional haloperidol or midazolam when used in the management of acute agitation in the emergency department.

to address significant knowledge gaps by several means: 1. investigate intramuscular use of sedative drugs within a predominantly chinese population, to address this void in international literature impacting the management of acute agitation. the multi-centre rct will determine the safety and efficacy of intramuscular olanzapine, in comparison with conventional medicines (haloperidol or midazolam) in a three-arm comparison for the sedation of acutely agitated patients in emergency department. specifically, we aim to determine if administration of intramuscular olanzapine (a)is more effective than sedation with intramuscular haloperidol or intramuscular midazolam alone; (b)is safer than sedation with comparison arms; (c)decreases the amount of subsequent redosing or alternative drugs required; (d)is more favourable than the haloperidol and midazolam arms with respect to safety, efficacy and adverse events. 2. investigate potential variables leading to emergency attendance and/or admission requiring parenteral sedation. these may include patient demographics and regular medications and adherence.

Eligibility criteria:
inclusion criteria: * emergency department patients, requiring parenteral drug sedation (as determined by an emergency clinician) will be enrolled. exclusion criteria: * patients will be excluded if there are 1. known hypersensitivity or contraindication to the study drugs 2. reversible aetiology for agitation (e.g. hypotension, hypoxia, hypoglycaemia) 3. known pregnancy 4. acute alcohol withdrawal 5. patients aged\>75 years.

Keywords: emergency emergency medicine sedation acute agitation
clinical efficacy and safety of axiom worldwide drx9000 axial decompression system for treatment of low back pain

Conditions: Low Back Pain

Summary: this study will document efficacy and safety of the axiom worldwide drx9000™ for treatment of low back pain (lbp) in a prospective, randomized, crossover, multicenter trial utilizing a standardized clinical research multimodal protocol. during the first two weeks subjects are randomized to receive either conservative care or drx treatment first and then cross over to receive either conservative care or drx treatment the next 6 weeks. this study will test the hypothesis that standardized 6-week treatment regimen of spinal decompression using drx9000™ will reduce chronic lower back pain more than conservative therapy (current baseline therapy).

this study will document efficacy and safety of the axiom worldwide drx9000™ for treatment of low back pain (lbp) in a prospective, randomized, crossover, multicenter trial utilizing a standardized clinical research multimodal protocol. during the first two weeks subjects are randomized to receive either conservative care or drx treatment first and then cross over to receive either conservative care or drx treatment the next 6 weeks. this study will test the hypothesis that standardized 6-week treatment regimen of spinal decompression using drx9000™ will reduce chronic lower back pain more than conservative therapy (current baseline therapy

Eligibility criteria:
inclusion criteria: * in addition to a diagnosis of lbp, all of the following criteria must be met: * male or female, \>18 years of age * able to provide written informed consent (icf) to the irb approved clinical multimodal protocol * chronic (onset more than 12 weeks) low back pain with an intensity level of \> 4 on a verbal rating scale for pain (vrs) of 0-10 (with 0 = no pain and 10 = worst possible pain) * completed necessary diagnostic medical history evaluation forms as described in the protocol to confirm the patient's diagnosis and eligibility for the study * willing and able to complete the 6 week 20 session drx9000 outpatient treatments and a minimum of 6 months follow-up exclusion criteria: * if any of the following exclusion criteria are present, the subject is not eligible: * pregnancy * evidence of neurologic motor deficits on clinical examination * evidence of spinal cord compression, metastatic cancer, tumor, hematoma, infection or compression fracture * severe spinal stenosis * litigation for health-related claim (in process or pending), worker's compensation, or personal injury cases * previous spine fusion surgery or instrumentation * hemiplegia or paraplegia * significant cardiovascular or metabolic disease, or abdominal aortic aneurysm * unwillingness to postpone other types of therapy for lbp that are not listed as adjuncts in the research protocol * known alcohol abuse or drug abuse * height less than 4 feet 10 inches (147 cm) or greater than 6 feet 8 inches (203 cm) * body weight greater than 300 pounds (136 kg)
role of routine nasogastric decompression after subtotal gastrectomy

Conditions: Cancer of Stomach

Summary: the aim of the study is to evaluate whether subtotal gastrectomy without post-operative nasogastric decompression is better in terms of early post-operative bowel function and chest complication.

nasogastric decompression is an intra-operative routine in most of the time to facilitate exposure of operative field during elective subtotal gastrectomy, but whether it should be retained post-operatively is controversial. nasogastric decompression helps to drain the gastric remnant in case there is edema around the gastrojejunostomy, ileus and delayed gastric emptying, which can theoretically relieve nausea and abdominal distension. besides, it may help decrease diaphragmatic splintage and hence decrease chance of chest infection if ileus occurs. however, nasogastric intubation could cause patient discomfort; also it has been shown that it would cause gastroesophageal reflux which may be associated with chest complication. there have been studies showing that routine post-operative nasogastric decompression is not necessary for gastrectomy in general, but the role in subtotal gastrectomy for stomach cancer is not well defined.

Eligibility criteria:
inclusion criteria:all patients suffering from carcinoma of stomach, decided for operation * subtotal, d1/d2 dissection * palliative resection exclusion criteria: * actively bleeding tumor * perforation of tumor * patient present with gastric outlet obstruction * combine organ excision * known diabetes with nephropathy