Kornimate/medical-research-clean huggingface dataset:
corticosteroid injection, extracorporeal shock wave therapy, and radiofrequency ablation for chronic plantar fasciitis:

Conditions: Chronic Plantar Fasciitis

Summary: chronic plantar fasciitis is a prevalent condition causing persistent heel pain, often refractory to conservative treatments. this prospective randomized controlled trial aimed to compare the effectiveness of corticosteroid injection (csi) , extracorporeal shock wave therapy (eswt), and radiofrequency thermal lesioning (rtl) in the management of chronic plantar fasciitis.

based on the investigators' understanding of the literature there are no randomized, controlled, prospective studies comparing the therapeutic effects of csi, eswt and rtl for recalcitrant plantar fasciitis. in this study, the investigators investigated and compared the outcomes of three treatment techniques in participants who had exhausted conservative treatment options over the past six months.

Eligibility criteria:
inclusion criteria: * persistant heel pain for ≥ 6 months * no response to at least 6 weeks of conservative treatment (including at least two of the following: nsaids, stretching exercises, ice, heel pads, physical therapy, or night splints) * age ≥ 18 * bmi ≤ 35 * vas ≥ 5 following the first step in the morning or after periods of prolonged inactivity * willingness to participate in the study exclusion criteria: * previous foot or ankle surgery, major trauma * tumor, osteomyelitis, or complex regional pain syndrome in the affected limb * allergy to local anesthesia or nsaids * pregnancy or breastfeeding * history of calcaneal fracture * previous cortisone injection, eswt, or rtl for similar complaints * bmi \>35 * age \< 18 * use of medications for neuropathic pain (pregabalin, gabapentin) * proximal nerve lesion (e.g., spinal stenosis, sciatica, tarsal tunnel syndrome) * regional skin or subcutaneous infections, fat pad atrophy * history of rheumatic disease, or hematologic conditions * history of peripheral vascular disease * seronegative arthropathies, heart failure, hepatic or metabolic disorders * pacemaker * history of clubfoot, pes cavus, or calcaneovalgus * diabetic neuropathy

Keywords: extracorporeal shock wave therapy (eswt) radiofrequency thermal lesioning (rtl) chronic plantar fasciitis corticosteroid injection (csi)
a safety and efficacy study of two japanese encephalitis vaccines chimerivax™-je and je-vax

Conditions: Japanese Encephalitis

Summary: the purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between chimerivaxtm-je and je-vax to the respective homologous virus strain after completion of vaccination course.


Eligibility criteria:
inclusion criteria: * subjects aged 18 or above * subjects in good general health. * females must have negative pregnancy test and be using adequate form of contraception exclusion criteria: * history of vaccination/infection with je or yellow fever or other flaviviruses * history of residence/travel to flavivirus endemic regions * history of anaphylaxis/serious adverse reactions * administration of vaccine within 30 days of study or during treatment period * clinically significant physical exam/medical history/lab abnormalities * pregnancy * excessive alcohol/drug abuse * hypersensitivity to constituents of je-vax® * blood transfusion/treatment with blood product within 6months of study and during study treatment period * known/suspected immunodeficiency * compromised blood brain barrier * employees of clinical research organization (cro)/study site staff * any other condition which would exclude subject.
communautary pediatric bacterial infection in intensive care unit

Conditions: Hospitalized Children; Severe Infection; Invasive Bacterial Infection

Summary: severe bacterial infections are a worldwide scourge. however, the epidemiology of this type of infection varies over time. it is therefore essential to monitor them in order to prevent them more effectively. at this time, in france, no monitoring exists for this kind of infections.

the main aim of this study is to assess the number of cases and describe the clinical, biological and microbiological characteristics of these cases of severe communautary invasive bacterial infections in children hospitalized in pediatric intensive care units. in addition, the management of these hospitalized children will be described.

Eligibility criteria:
inclusion criteria: * age \<18 years (only hospitalized children) * severe communautary bacterial infection defined by hospitalization in a pediatric intensive care unit (documentation of infection by identification of the bacteria in a sterile environment). exclusion criteria: * refusal by one of the parents or by child in understanding age * nosocomial infection
tap block with liposomal bupivacaine versus pre-incisional wound infiltration with bupivacaine for postoperative pain

Conditions: Postoperative Pain

Summary: in this randomized, controlled, double-blinded trial we plan to evaluate post-operative pain relief after laparoscopic-assisted transversus abdominis plane (tap) block using liposomal bupivacaine plus bupivacaine versus pre-incisional would infiltration with bupivacaine in patients undergoing total laparoscopic or robotic assisted laparoscopic hysterectomy.

patients undergoing laparoscopic or robotic assisted total hysterectomy at erlanger hospital will be randomized into one of two groups to receive either laparoscopic assisted tap block with liposomal bupivacaine and bupivacaine (group a) or pre-incisional bupivacaine (group b). the remaining aspects of the perioperative care, including the general anesthesia care and postoperative care will be similar for all patients. ideally, patients will be informed and consented for the study in the preoperative clinic setting. they will be randomized in the pre-anesthesia care unit. patients in group a will receive laparoscopic-assisted bilateral tap blocks using 10cc liposomal bupivacaine, 10cc bupivacaine 0.25% and 10cc normal saline one each side. patients in group b will receive a total of 20cc pre-incisional bupivacaine divided between each of the trocar sites. all patients will receive ketorolac 30 mg, iv at the conclusion of surgery. all patients will be offered either oral pain medications or patient controlled anesthesia (pca) opiate pain medication as indicated. morphine equivalents will be calculated. postoperative pain control will be assessed using visual analog pain score (vas). this will be done by recovery room personnel who will be blinded as to whether the patients received tap block or pre-incisional anesthetic. vas will be assessed at rest at 1 hour and 2 hours after arrival to pacu. patients will be assessed with overall benefit of anesthesia score (obas) questionnaires at postoperative days 1, 2 and 7. obas questionnaires will be done by personnel blinded to anesthesia technique. patients will also be blinded as to which group they were in. total morphine equivalents of intraoperative and postoperative pain medications will be calculated through postoperative day 7.

Eligibility criteria:
inclusion criteria: * asa physical status 1-3, * scheduled for laparoscopic or robotic assisted laparoscopic hysterectomy, * able to participate personally or by legal representation in informed consent exclusion criteria: * history of relevant allergy to the study drugs (bupivacaine), * chronic opioid use or drug abuse history, * inability to understand the study protocol, * refusal to provide written consent, * soft tissue infection of the abdominal wall and skin

Keywords: laparoscopic hysterectomy robotic assisted hysterectomy
early intervention for families experiencing homelessness: a randomized trial comparing two parenting programs

Conditions: Behavior Problem; Parenting

Summary: this study aims to compare the efficacy in delivering two evidence-based parenting programs to families and young children experiencing homelessness. outcomes evaluated include feasibility, treatment completion, treatment satisfaction of delivery of interventions as well as child outcomes (e.g., behavior problems, trauma symptoms) and parenting outcomes (parenting stress and parenting skills).

the number of homeless families in the u.s. has increased since the 1980s to over half a million as of 2018. most troubling, in 2013 (the most recent year for which census data is available) one in every 30 children in the u.s., or 2.5 million, experienced homelessness. in addition to having disproportionally higher rates of unmet health needs (e.g., acute health problems, trauma-related injuries), children experiencing homelessness have staggering mental health needs such that 78% suffer from at least one mental health issue (e.g., depression, behavior problems) along with academic/developmental delays. given that over half of all homeless children in the us are under the age of 6, it is particularly important to investigate the effectiveness of evidence-based parenting programs within a homeless population. this study aims to compare the efficacy in delivering two evidence-based parenting programs to families and young children experiencing homelessness.

Eligibility criteria:
inclusion criteria: * any child between the ages of 2 and 5 and his/her mother who is currently homeless and living in the lotus house shelter. exclusion criteria: * family is already involved in a parenting program or does not speak english or spanish.

Keywords: early intervention parenting homelessness parent child interaction therapy child parent psychotherapy behavior problems trauma symptoms
combined inspiratory muscle and 'whole muscle' training in children with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: to study the effects of an 8-week combined inspiratory muscle training and exercise (resistance+aerobic) program on of a lung volume, inspiratory muscle strength (maximal inspiratory pressure, pimax) and cardiorespiratory fitness (maximal oxygen uptake, vo2peak) (primary outcomes)and dynamic muscle strength, body composition and quality of life (qol) in children with cystic fibrosis (cf) (secondary outcomes).

the investigators hypothesized that the combined training program would significantly benefit most of the aforementioned variables (especially, primary outcomes).

Eligibility criteria:
inclusion criteria: * boy/girl aged 6-17 years * living in the madrid area exclusion criteria: * severe lung deterioration \[forced expiratory volume (fev1) \<50% of expected\] * unstable clinical condition (hospitalization within the previous 3 months) * burkholderia cepacia infection * any disorder (e.g. muscle-skeletal) impairing exercise.

Keywords: cystic fibrosis exercise children cardiorespiratory fitness muscle strength pulmonary function quality of life
a phase 2, randomized, placebo-controlled, double-blind study of eg017 in female patients with stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: the purpose of this study is to determine whether eg017 is safe and effective in the treatment of stress urinary incontinence in postmenopausal women.

the main purpose of this study is to assess the efficacy of eg017 in female patients with stress urinary incontinence (sui) compared with placebo as measured by the percent change in the urinary incontinence volume measured in a 1-hour pad test from baseline at week 12.

Eligibility criteria:
inclusion criteria: sui symptoms of at least 6 months duration urinary incontinence in the 1-hour pad test weight≥5g and\<30 g moderate to severe urinary incontinence evaluated by iciq-sf exclusion criteria: patient has been diagnosed with mixed urinary incontinence (mui) that is predominantly uui patient is considered to have sui that would not be expected to improve unless treated with surgical therapy patient had a history of surgical treatment for urinary incontinence (trans-obturator tape surgery, tension-free vaginal tape surgery, etc.) patient has stage ii or more of pelvic organ prolapse (pop), or had a history of pop repair surgery before prior to study entry patient has a serious illness or medical condition

Keywords: stress urinary incontinence selective androgen receptor modulator (sarm)
ercp with and without eus guided hgs for bilateral biliary decompression in malignant hilar biliary obstruction

Conditions: Malignant Hilar Stricture

Summary: a prospective randomized clinical trial to evaluate efficacy and safety of combined eus-hgs and ercp compared to ercp for bilateral biliary decompression in advanced malignant hilar biliary obstruction. the primary outcome will be technical success, clinical success, procedural duration, and re-interventions. secondary outcomes will be the rate of adverse events. patients will be followed up at 1 and 3 month intervals

bilateral stenting by endoscopic retrograde cholangiopancreatography in malignant hilar biliary obstructions (mhbo) is challenging and technically difficult. eus hepaticogastrostomy (eus-hgs) has been increasingly used as an alternative method to achieve internal biliary drainage in mhbo. because of the difficulty of ercp in such scenario, the combination of eus-hgs and ercp provides a possible chance of longer stent patency with less event of stent clogging aim of the work: to evaluate efficacy and safety of combined eus-hgs and ercp compared to ercp for bilateral biliary decompression in advanced mhbo. the inclusion criteria will be presence of inoperable mhbo with elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal the study patients will be randomized in 1:1 ratio to: ercp biliary drainage (ercp-bd) group: bilateral metallic stents insertion will be attempted by transpapilary approach. combined ercp and eus-hgs group: unilateral metallic stent will be inserted on right side by transpapilary approach and a transmural stent will be inserted on left side by eus. technical success, clinical success, procedural duration, and re-interventions and adverse events will be assesed

Eligibility criteria:
inclusion criteria: * presence of inoperable malignant hilar biliary obstruction on magnetic resonance cholangiography, computed tomography and/or direct cholangiography bismuth type iii \& iv only. * histologically confirmed malignant hilar biliary obstruction. * elevated serum bilirubin at least 3 times above the upper limit of normal (1.2 mg/dl). * absence of duodenal narrowing/obstruction. * accept sharing in the study exclusion criteria: * pregnancy. * distal biliary obstruction as the main lesion. * benign biliary stenosis. * malignant hilar biliary obstruction bismuth type i and ii. * presence of duodenal obstruction. * surgically altered anatomy or inability to access the major duodenal papilla. * patients underwent previous intervention for biliary drainage. * previously failed biliary cannulation at ercp. * large volume ascites. * patients unfit for anesthesia. * patients having uncorrectable coagulopathy or thrombocytopenia. * history of allergy to radiocontrast agents. * refuse sharing in the study.

Keywords: malignant hilar biliary obstruction endoscopic retrograde cholangiopancreatography endoscopic ultrasound guided hepaticogastrostomy
a digital flu intervention for people with cardiovascular conditions

Conditions: Cardiovascular Diseases; Atrial Fibrillation; Abnormal Heart Rhythms; Cardiac Arrest; Heart Attack; Myocardial Infarction; Coronary Heart Disease; Heart Failure; Stroke; Cerebrovascular Accident

Summary: a 6-month prospective, digital randomized controlled trial targeting approximately 49,000 individuals to evaluate the effectiveness of an influenza vaccination intervention during influenza season for people with cardiovascular conditions


Eligibility criteria:
inclusion criteria: * age 18 years or older * resides in the u.s. * speaks, reads, and understands english * has self-reported being diagnosed with any of the following cardiac conditions below in their achievement profile: * atrial fibrillation or afib * abnormal or irregular heart rhythm, other arrhythmic heart disease * cardiac arrest, or heart attack (myocardial infarction) * coronary heart disease like a heart blockage, treated with medications, a stent in the heart, or sometimes bypass surgery- * heart failure, like congestive heart failure * stroke or cerebrovascular accident (cva) exclusion criteria: * participated in step 1, part 2 semi-structured interviews used to obtain feedback on the intervention messages

Keywords: cardiovascular disease flu
resolute onyx china single arm study

Conditions: Ischemic Heart Disease; Stenotic Coronary Lesion; Cardiovascular Diseases; Arteriosclerosis; Coronary Artery Disease

Summary: it is a single arm clinical evaluation of safety and efficacy of the medtronic resolute onyx™ zotarolimus-eluting coronary stent system in subjects who are eligible for percutaneous transluminal coronary angioplasty (ptca) in de novo lesions amenable to treatment with resolute onyx™ stent system in china.

this study is a pre-market, prospective, multi-center, single arm trial. subjects will be enrolled and followed through 5 years (screen, implant procedure(including post-procedure assessment),30-day, 6 months, 9 months-subjects implanted with fringe size, and annual assessments from 1-5 years).

Eligibility criteria:
key inclusion criteria: * the subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, and the ib of resolute onyx stent. * the subject requires treatment of up to 3 target lesions in up to 2 separate target vessels \[2 target lesions in 1 vessel (including its side branches) and 1 target lesion in a separate vessel (including its side branches)\] amenable to treatment with stents with diameter from 2.25 mm to 5.0 mm key exclusion criteria: * known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, p2y12 inhibitors, mtor inhibiting drugs such as zotarolimus, biolimus a9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. biolinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated * pci of the target vessel within 9 months prior to the procedure * active bleeding * subjects with a life expectancy of less than 12 months * participation in another clinical study * pregnant, or lactating women

Keywords: major adverse cardiac events (mace) myocardial infarction (mi) late lumen loss (lll) target lesion revascularization (tlr) target vessel revascularization (tvr) target vessel failure (tvf) target lesion failure (tlf) stent thrombosis (st) percutaneous coronary intervention (pci)
efficacy, tolerability and impact on quality of life of propiverine in patients with overactive bladder syndrome

Conditions: Overactive Bladder Syndrome

Summary: the purposes of this study were to assess quality of life (qol) and urination urge, incontinence, and micturition frequency including nocturia after 4 and 12 weeks treatment with propiverine.

the drug being tested in this study is called propiverine. propiverine is being tested to evaluate quality of life (qol) and improvement of oab symptoms in people who take propiverine. the study will enroll approximately 1000 patients who the treating physician decided to treat with propiverine 15mg tablets or 30 mg regulated release capsules as part of their normal clinical practice. all participants will be asked to keep a voiding diary for 2 consecutive days and to complete a qol questionnaire after 1st visit and before each subsequent visit. this multi-centre trial will be conducted in belgium. the overall time to participate in this study is up to 12 weeks. participants will make 3 visits to their healthcare provider.

Eligibility criteria:
inclusion criteria: * 1. written informed consent. 2. at least 18 years of age. 3. patients with complaints of overactive bladder syndrome (oab) without urge incontinence, oab with urge incontinence, or with mixed urinary incontinence. 4. patients who consult their gp or an urologist for the first time with these complaints or who stopped their oab treatment since at least one month. 5. receiving a propiverine prescription according to the summary of product characteristics (spc). exclusion criteria: * none, as per the spc contra-indications

Keywords: drug therapy
rational use of personal protective equipment during covid-19 pandemic

Conditions: Covid19; Personal Protective Equipment

Summary: this study aims to improve the personal protective equipment (ppe) used while treating patients with covid-19, to protect staff and avoid cross-infection of patients. protecting staff from infection during the covid pandemic is critical to maintaining health services. mistakes in using protective equipment (ppe) are the commonest avoidable factor in staff becoming infected at work. recently, intensive care doctors have also reported an increase in the spread of dangerous multi-resistant bacteria between patients, which appears likely to be transmitted between patients by level 2 ppe worn by staff (specifically gown sleeves). this study therefore seeks to develop and test a new protocol to decrease cross-infection risks whilst using level 2 ppe.


Eligibility criteria:
inclusion criteria: 1. nhs staff and works in the adult intensive care unit, neuro intensive care unit or cardio-thoracic intensive care unit 2. trained in the correct use of level 2 ppe according to current guidance 3. trained in icu covid19 intubation and proning protocols 4. willing and able to give informed consent for participation in the study. exclusion criteria: 1. taking any medication which can cause photosensitivity reactions in the preceding 3 months

Keywords: ppe multi-drug resistance organism cross-infection
observational study describing the usual clinical practice use of novoseven® in the home treatment of joint bleeds in patients with haemophilia a or b and inhibitors

Conditions: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B

Summary: this trial is conducted in africa and asia. the aim of this study is to evaluate the efficacy of home treatment of joint bleeds (haemarthrosis) with novoseven® (activated recombinant human factor vii) in patients with haemophilia a and b patients with inhibitors.


Eligibility criteria:
inclusion criteria: * patients with congenital haemophilia and inhibitors to factor viii or ix * indication of activated recombinant human factor vii for the treatment of joint bleeding located in elbow, shoulder, wrist, hip, knee, ankle exclusion criteria: * known or suspected allergy to study product(s) or related products * clinically relevant coagulation disorders other than congenital haemophilia a or b
grip movement training for adults with fine motor limitation

Conditions: Hand Injuries and Disorders

Summary: this study is to test the system composed by a 3d virtual environment, attached to the leap motion, evaluating its effects on the rehabilitation of hand movements in patients with motor alteration.

in order to elaborate the virtual environment, softwares for 3d content creation were used. the virtual environment is formed by four phases, each one having three spheres that are supposed to be inserted, one by one, into a hole located on the scenario floor. each phase presents a level of difficulty, from pushing the object to performing the grip movement. by the end of each phase, a log file is generated with the time spent on it.

Eligibility criteria:
inclusion criteria: * men and women with age equal or higher than 18 years old; * having clinical diagnosis of neurological pathology; * presenting fine motor coordination deficit and in grip strength; * being able to understand instructions in order to perform the tasks of the virtual environment; * minimum score of 23/24 (from a total of 30) in the mini-mental state examination (mmse) exclusion criteria: * not accepting to participate in this research