Kornimate/medical-research-clean huggingface dataset:
evaluation of an educational intervention on abscesses in people who self-inject drugs

Conditions: People Who Inject Drugs

Summary: the goal of this cluster randomised controlled trial (crct) is to to evaluate the effectiveness of an educational intervention combining training in hand-washing with the supply of mono-rubs on the reduction of skin abscesses (both observed and self-reported) in people who inject drugs (pwid). the main questions it aims to answer are: * does an educational intervention change the incidence of injection-related skin and soft tissue infection (ssti) like abscesses in pwid? * does the educational hand-washing intervention improve injection practices in terms of hand-hygiene in pwid? according to cluster randomisation, pwid will be assigned to: * standard harm reduction (hr) services to reduce abscesses plus an educational hand-washing intervention (intervention arm) * standard hr services only (control arm) to measure the effectiveness of the educational hand-washing intervention, the primary outcome will be the reduction in abscess prevalence compared in both groups. statistical analyses for the primary outcome will involve comparing the reduction in abscess prevalence in the intervention arm with that in the control arm. this prevalence will be measured from observed and self-declared data, collected from the injection-site photographs and the face-to-face injection-related ssti questionnaire, respectively.


Eligibility criteria:
inclusion criteria: * over 18 years old, * french-speaking, * reporting to have injected drugs at least once during the previous week, * and providing free and informed consent to participate. exclusion criteria: * not regularly going to the participating hr centre in the relevant city, * having an alcohol and/or alcohol-based hand rub (abhr) excipient intolerance/allergy, * being under legal protection (guardianship or judicial protection), * current pregnancy.

Keywords: harm reduction soft skin and tissues infections community-based participatory research
impact of extent of antral resection on outcomes of sleeve gastrectomy

Conditions: Obesity

Summary: laparoscopic sleeve gastrectomy (lsg) is a surgical technique that treats morbid obesity by both restrictive and hormonal action. consecutive patients with morbid obesity treated by lsg at our department were evaluated. patients enrolled in the study were randomized into group i: lsg begin the division 2 cm from the pylorus and group ii: lsg begin the division 6 cm from the pylorus. the primary outcome measure was the % of excess weight loss (%ewl); secondary outcomes included operative time, day to resume oral feeding, postoperative morbidity and mortality, improvement of comorbidity.

this prospective randomized study was designed to compare between the beginning of sleeve gastrectomy 2 cm versus 6 cm from the pylorus with special regards to intraoperative problems, weight loss, improvement of comorbidities, postoperative complications, nutritional and elemental deficiencies. consecutive patients, who were treated for morbid obesity by laparoscopic sleeve gastrectomy (lsg) at the department of general surgery, mansoura university, egypt, during the period from january 2008 to january 2012, were eligible for the study. the exclusion criteria included patients above 60 or below 18 years old, history of upper laparotomy, unfit for anaesthesia or laparoscopy, major psychological instability, and drug abuse. the operation was done under general anesthesia. patient was in supine position with splitting of the operating table legs.gastric transection started 2 cm proximal to the pylorus using 60 mm, green endo-stapler (ethicon, usa) (gi) or 6 cm from the pylorus (g ii). the following staplers were placed approximately 1 cm from the bougie in the direction of the gastroesophageal junction. group i: lsg begin the division 2 cm from the pylorus and group ii: lsg begin the division 6 cm from the pylorus. the primary outcome measure was the % of excess weight loss (%ewl); secondary outcomes included operative time, day to resume oral feeding, postoperative morbidity and mortality, improvement of comorbidity.

Eligibility criteria:
inclusion criteria: * patients, who were treated for morbid obesity by laparoscopic sleeve gastrectomy (lsg) exclusion criteria: * patients above 60 or below 18 years old, history of upper laparotomy, unfit for anaesthesia or laparoscopy, major psychological instability, and drug abuse.

Keywords: bariatric surgery, sleeve gastrectomy, gastric leak
randomised controlled trial for the selfback project

Conditions: Low Back Pain

Summary: the intervention consists of a digital decision support system delivering a weekly plan of suggested activities that the participant can use to self-manage their low back pain (lbp) via an smartphone app.

the selfback intervention consists of the selfback system, that provides the participants with an individually tailored weekly plan of suggested activities to use in their self-management of low back pain. the selfback system constitutes a data-driven decision support system that uses case-based reasoning to capture and reuse participant cases to suggest the most suitable self-management plan for participants. the system is an intelligent system delivering self-management plans tailored to individual participant characteristics. information about participant characteristics is collected via a (baseline) questionnaire, weekly self-reports via the app on symptom progression etc., and a wristband that detect daily number of steps. the weekly plans are presented in an app to participants. the weekly plan includes three categories of content; 1. information/education 2. recommended daily number of steps 3. recommended strength and flexibility exercises outcomes are collected as baseline, 6 weeks, 3, 6, 9 months.

Eligibility criteria:
inclusion criteria: * seeking care from primary health-care practice (general practitioners, physiotherapists, chiropractors) or a local outpatient spinecenter (dk) for non-specific lbp within the past 8 weeks * lbp of any duration * mild-to severe pain-related disability rated as 6 or above on the roland morris disability questionnaire * age: ≥18 years * own and regularly use a smart phone (with at least android 7.0 or ios11.0) with internet access (wi-fi and/or mobile data) * have a working email address and have access to a computer with internet access to complete questionnaires in a web browser. exclusion criteria: * not interested, * unable to speak, read or understand the national language (danish/ norwegian), * cognitive impairments or learning disabilities limiting participation, * mental or physical illness or condition limiting participation, * inability to take part in exercise/physical activity, * fibromyalgia (diagnosed by a health care professional), * pregnancy, * previous back surgery * ongoing participation in other research trials for lbp management.

Keywords: digital decision support system app self-management
prolonged multimodal analgesia for post-discharge pain control after primary total hip arthroplasty

Conditions: Osteoarthritis, Hip

Summary: this is a prospective, three-arm, comparative study with a provider-crossover design. the first arm will comprise the standard of care pain regimen after discharge, which comprises prn oxycodone, tramadol, and acetaminophen. the second arm will comprise a multimodal pain regimen; however, patients will still be routinely provided prn oxycodone and tramadol to use on an as needed basis. the third arm will comprise a multimodal pain management protocol, which does not routinely allow for opioid consumption. however, patients will be provided a one week supply of oxycodone and tramadol for emergency pain relief only.


Eligibility criteria:
inclusion criteria: * patients undergoing unilateral, primary cementless tha with underlying diagnosis of osteoarthritis. * asa i - iii * spinal anesthesia * male and female over 18 who are willing and able to provide informed consent exclusion criteria: * opioid use within 3 months prior to surgery * general anesthesia * non-english speaking * asa iv or greater * allergy/contraindications to protocol medications * renal insufficiency with cr \> 2.0 or hepatic failure * sensory/motor disorder involving the operative limb * planned or unplanned discharge to rehab * length of stay \>3 days * revision or conversion tha * cigarette smokers
simplification to atazanavir/ritonavir + lamivudine as maintenance therapy

Conditions: HIV Infection

Summary: a switch to a regimen consisting of atv/rtv 300/100 mg qd + 3tc 300 mg qd in hiv-1 infected subjects in their first antiretroviral regimen and who are virologically suppressed on a regimen which consists of 2 nrtis + any 3rd agent, is non-inferior to continue or switch to atv/rtv 300/100 mg qd + 2 optimized nrtis for maintenance of virological suppression.

clinical trial, phase iv, randomized, open label, multicenter with approved drugs in their use conditions. a switch to a regimen consisting of atv/rtv 300/100 mg qd + 3tc 300 mg qd in hiv-1 infected subjects in their first antiretroviral regimen and who are virologically suppressed on a regimen which consists of 2 nrtis + any 3rd agent, is non-inferior to continue or switch to atv/rtv 300/100 mg qd + 2 optimized nrtis for maintenance of virological suppression.

Eligibility criteria:
inclusion criteria: * signature of informed consent * at least 18 years old * patients on their 1st arv treatment consisting on 2 nrtis + 1 third agent for at least 1 year * undetectable viral load for at least 6 months prior to inclusion in the study (vl\<50 c/ml in 2 determinations 6 months apart; blips are not allowed). * requirement of arv treatment change due to toxicity, intolerance or simplification. * clinically stable. exclusion criteria: * pregnant women or women who plan to get pregnant during the study. * breast feeding * history of change of any arv treatment component for any reason 4 months prior to the inclusion in the trial * history of arv treatment change due to virological failure * history of confirmed virological failure defined as one single vl \>400 c/ml or at least 2 vl between 50 and 400 c/ml one year after an indetectable vl was achieved. * absence of hiv genotype prior to arv treatment initiation. * resistance mutation to any of the study drugs (atv, rtv, 3tc) * hbv infection. * history of toxicity or intolerance to atv, rtv or 3tc. * gilbert's syndrome. * use of contraindicated drugs. * lab abnormalities grade 4.

Keywords: hiv aids atazanavir simplification
an a study assessing subject satisfaction with a-101 topical solution for seborrheic keratoses

Conditions: Seborrheic Keratosis

Summary: this study is an open-label study designed to evaluate subject's satisfaction after treatment of seborrheic keratoses with a-101 40%.


Eligibility criteria:
inclusion criteria: 1. subject can comprehend and is willing to sign an informed consent for participation in this study. 2. male or female between the ages of 30 and 75 years old. 3. subject has 3 eligible seborrheic keratoses; 2 target sks must be on the face, and the additional 1 target sk must be on the neck or decolletage. 4. subjects must have had cryosurgery for sk removal within the last 6 months and prior to first treatment with a-101 topical solution. 5. target and non-target sks must not have been previously treated. 6. subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of any target or non-target sk or which exposes the subject to an unacceptable risk by study participation exclusion criteria: 1. subject has clinically atypical and /or rapidly growing seborrheic keratoses. 2. subject has current systemic malignancy. 3. subject would require the use of any topical treatment (e.g., moisturizers, sunscreens) to any of the target or non-target sks 12 hours prior to any study visit. 4. subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations
preliminary study of microwave tumoral ablation performances for the treatment of pulmonary, renal and bone neoplasia.

Conditions: Lung Tumor; Bone Tumor; Renal Tumor

Summary: the aims of this work were to assess the feasibility, efficacy, short-term outcome and safety of microwave ablation in the treatment of malignant bone, lung and renal tumors.


Eligibility criteria:
inclusion criteria: * men and women \> 18 years old * thermoablation indication of renal neoplasia, bone or lung decided during a multidisciplinary consultation meeting - generally speaking, the indications are: (i) inoperable primary malignant tumor or secondary malignant tumor, (ii) resectable primary malignant renal and lung tumor with medical contraindication to surgery or general anesthesia * signature of informed consent for participation * affiliation to a social security scheme or french beneficiary of such a regime. exclusion criteria: * contraindication to percutaneous thermoablation * renal or lung tumor up to 4 cm * women of childbearing age, premenopausal, non-sterilized surgically, and unwilling to use effective contraception * legal incapacity or legal capacity limited * person unlikely to cooperate in the study and / or low degree of cooperation expected by the investigator * person without health insurance * pregnant women
dtx algorithms for personalized parkinson's disease treatment and medication plan optimization

Conditions: Parkinson Disease

Summary: the study is aimed at developing digital therapeutics (dtx) algorithms for personalized pd treatment and medication plan optimization, based on real world data (rwd) collected from patients via digital mobile app and wearable sensors. the study design is observational/noninterventional, prospective, single-arm, aimed at collecting data from wearable sensors for validation of symptom detection algorithms, through (1) a supervised in-clinic motor assessment, performed using validated clinical scales (visit 3, visit 4), and (2) an unsupervised, home-based, 6-month (visit 3 to visit 4) data collection from wearable devices (passive monitoring) for algorithm cross-validation using patient reported outcomes (proms) and remote clinical assessments. the devices used in the study will be a commercial smartwatch (garmin vivosmart 5) for inertial data collection and a digital application through which subjects will report proms via a digital symptom diary. screening visits (visit 1 and visit 2) will be conducted prior to enrollment to verify eligibility criteria through clinical assessments, the subjects' symptom diary, and by assessing adherence to the use of the study tools provided (i.e., mobile application and smartwatch).


Eligibility criteria:
inclusion criteria: 1. written informed consent (ic) obtained. 2. age \> 18 years. 3. male or female patients meeting the mds clinical diagnostic criteria for parkinson's disease (postuma et al., 2015) 4. at least one motor symptoms off-period each day, excluding early morning akinesia. 5. on treatment with levodopa 6. stable levodopa regimen for 4 weeks before screening visit; 7. levodopa equivalent daily dose (ledd) \> 400 mg, or levodopa intake \> 2 administration/day; 8. the subject is willing and able to attend study procedures and to use wearable and mobile devices. exclusion criteria: 1. secondary or atypical pd. 2. cognitive problems which significantly impair his/her ability to give an ic and perform the study tasks. 3. levodopa equivalent daily dose (ledd) \> 800 mg, or levodopa intake \> 8 administration/day; 4. any condition that in the opinion of the investigator would interfere with the interpretation of the study results or constitute a health risk for the subject if he/she takes part in the study. 5. concomitant participation to clinical trials with investigational medicinal products. 6. failure to show, in opinion of the investigator, acceptable/appropriate use of wearable and mobile device (e.g. weekly average daily wearable wear time \< 8 hours). having an advanced treatment (including deep brain stimulation, apomorphine, duodopa), is not an exclusion criterion, as well as the subject decision or capability to attend the exercise and speech training programs within the mobile app.
a study of kw-3357 in congenital antithrombin deficiency

Conditions: Congenital Antithrombin Deficiency

Summary: the aim of this study is to determine the pharmacokinetics, safety and tolerability of kw-3357 in asymptomatic subjects with congenital antithrombin deficiency.

patients with congenital antithrombin deficiency are at increased risk of venous thrombosis and pulmonary embolism especially when undergoing certain high risk procedures. antithrombin replacement therapy is often administered during these periods, with or without low molecular weight heparin. prior to assessing the efficacy of kw-3357, a new recombinant human antithrombin, the present study will determine it's pharmacokinetics, safety and tolerability in subjects who have congenital antithrombin deficiency but who are currently asymptomatic and not undergoing a high-risk procedure. up to 16 evaluable subjects will be enrolled at multiple investigational sites over a period of approximately 7 months.

Eligibility criteria:
inclusion criteria: * male or female subjects at least 18 years of age with congenital antithrombin deficiency (at activity ≤60% of normal) in a stable condition without evidence of acute thromboembolic events * signed iec-approved informed consent form * subjects must not have received an infusion of antithrombin for at least 14 days before screening * patients of reproductive potential must agree to follow accepted birth control methods during the study exclusion criteria: * subjects who are classified as morbidly obese (defined by the presence of a body mass index \>40 kg/m2) * subjects who have participated in a study with an investigational drug within 30 days of screening or within 5.5 times the elimination half-life of the investigational drug before screening, whichever period is greater * subjects with any clinically relevant medical history or current condition or physical findings, ecg, or laboratory values which could interfere with the objectives of the study or the safety of the subject * subjects using non-steroidal anti-inflammatories, fondaparinux sodium, dabigatran or rivaroxaban or who are expected to be treated with these drugs during the study * subjects who have concomitant nephrotic syndrome * female subjects who are pregnant or lactating * subjects who are taking heparin, low molecular weight heparin and/or oral anticoagulants, with the exception of vitamin k antagonists (eg, warfarin)

Keywords: antithrombin thrombosis pharmacokinetics hereditary antithrombin deficiency congenital antithrombin deficiency
optivol® care pathway

Conditions: Heart Failure

Summary: medtronic, inc. is sponsoring the optivol® care pathway study, a prospective, randomized, multi-center, post-market clinical trial in the united states. the purpose of this clinical trial is to compare monthly versus quarterly review of cardiac compass® trends with optivol for initiation of clinical action. it is hypothesized that monthly review of cardiac compass trends with optivol will shorten time to clinical action as compared to quarterly review.


Eligibility criteria:
inclusion criteria: * subject (or subject's legally authorized representative) is willing and able to sign and date written consent form and authorization for access to and use of health information * subject is at least 18 years of age * subject is willing and able to comply with clinical investigation plan * subject is willing and able to transmit data using medtronic carelink® network * subject has market released right atrial (ra) (if applicable), right ventricular (rv), and left ventricular (lv) (if applicable) leads and one of the following generators implanted: concerto® crt-d - model c154dwk, virtuoso® dr icd - model d154awg, virtuoso® vr icd - model d154vwc, consulta™ crt-d - model d224trk, secura™ dr icd - model d224drg, secura™ vr icd - model d224vrc, or any future market released medtronic generator with wireless telemetry, cardiac compass with optivol fluid status monitoring, and that is supported by the medtronic carelink network exclusion criteria: * subject is enrolled in a concurrent study with the exception of a study approved by the medtronic clinical trial leader prior to enrollment * subject has life expectancy of less than 1 year

Keywords: heart failure implantable cardioverter defibrillator (icd) cardiac resynchronization therapy with defibrillator (crt d) optivol®
medication-overuse headache (moh): withdrawal or use of preventative medications directly?

Conditions: Headache

Summary: it is a common belief that patients with moh rarely respond of preventative medications whilst overusing acute medications. however, no randomized trial has been done previously to prove such statement. based on some clinical experiences, our hypothesis are patients with probably moh may benefit from use of preventive medications better than treatment with abrupt withdrawal or no specific treatment.

this randomized multi-centre study started january 2004, and patients with probably moh have been included from five different university hospitals in norway. the last patient was included november 9th 2006, final inclusion date was december 31th 2006. at this time a total of 64 patients with probable moh according to the international classification of headache disorders, 2nd edition (2004) were included. the included patients were randomized to one out of three possible options: 1. abrupt withdrawal of the acute medication(s) they have been overusing. after 3 month: use of preventative medication (best choice)in those who need such treatment, 12 month follow-up. 2. start with preventative medication (best choice) directly without abrupt withdrawal, 12 month follow-up. 3. no specific treatment (controls), 5 month follow-up.

Eligibility criteria:
inclusion criteria: * fulfill 8.2.7 probably medication-overuse headache according to the international classification of headache disorders, 2th edition (2004) exclusion criteria: * no benefit of all available preventative medications * no benefit of abrupt withdrawal lasting more than 3 weeks of acute medication that has been overused * cluster headache * chronic paroxysmal hemicrania * hemicrania continua, pregnancy * use of pain killers for other reasons than headache * other reasons for chronic daily headache than medication-overuse

Keywords: medication-overuse headache preventative medication controls follow-up randomized abrupt withdrawal
pharmacokinetics, safety and tolerability of the preservative-free fixed dose combination of tafluprost 0.0015% and timolol 0.5% eye drops

Conditions: Healthy Volunteers

Summary: the objective of this study is to investigate the pharmacokinetics, safety and tolerability of the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (fdc) to those of preservative-free tafluprost 0.0015% and timolol 0.5% eye drops in healthy volunteers.


Eligibility criteria:
inclusion criteria: * aged 18 to 45 years * good general health * meet best corrected etdrs visual acuity exclusion criteria: * significant systemic or ocular disease * history of eye surgery, including refractive surgery * allergy or hypersensitivity to study drug * low heart rate (\<50 bpm) * clinically relevant low blood pressure * asthma * bradycardia * use of contact lenses within one week prior to screening or during the study * clinically significant obesity (body mass index \> 30 kg/m2) * blood donation within 2 months prior to screening * females who are pregnant or lactating and females not using adequate contraceptives

Keywords: pharmacokinetics