Kornimate/medical-research-clean huggingface dataset:
effectiveness of occupation-based intervention compared with therapeutic exercise for older adults with shoulder oa.

Conditions: Osteoarthritis Shoulder

Summary: as a registered and licensed occupational therapist, i completed a six-week evidence based research study to determine the effects of occupation-based intervention and therapeutic exercises versus therapeutic exercises alone.

importance: there is a need for evidence to support occupation-based intervention (obi) for older adults with shoulder osteoarthritis (oa). objective: to evaluate the effectiveness of obi on function in older adults with shoulder oa compared to therapeutic exercise (te). design: randomized controlled trial. six-week intervention. 1-week and 4-week follow-up. setting: outpatient clinic. participants: ten older adults with diagnosis of shoulder oa via convenience sampling. intervention: participants were seen two times/week for six weeks. the obi group completed 30 minutes of te followed by 30 minutes of obi. the te group completed 60 minutes of te. outcome and measures: functional outcomes were assessed at pre-, 1-week post, and 4-weeks posttreatment using the quickdash as the primary outcome measure.

Eligibility criteria:
inclusion criteria: * diagnosis of shoulder osteoarthritis (confirmed by physician examination or radiographic imaging) * aged 65 years or older exclusion criteria: * previous shoulder injuries * acute pathology * previous shoulder surgery * current use of pain medication * inflammatory arthritis * upper extremity neuropathy or myopathy * current participation in a home exercise program * score of \<18 on the mini-mental state examination (mmse)
a study to check liver health in boys with xlmtm, a serious genetic muscle condition

Conditions: X-Linked Myotubular Myopathy

Summary: xlmtm (x-linked myotubular myopathy) is a serious genetic muscle condition. it is caused by changes in the mtm1 gene which stops or slows down normal muscle development, causing severe muscle weakness. there is currently no cure for xlmtm. ongoing care is needed to manage symptoms and prevent further medical problems from this condition. recent research shows that individuals with xlmtm often have reduced bile flow which can affect liver and gallbladder health. bile is a liquid made in the liver that helps digest fat. ongoing liver health checks may help with the routine care of people with xlmtm. there is a need to understand liver problems that develop in individuals with xlmtm over time. the main aim of the study is to learn how many boys with xlmtm have new cases of liver problems during the study. this study is about collecting information only. this is known as an observational study. the individual's doctor decides on treatment, not the study sponsor (astellas). in this study, boys under 18 diagnosed with xlmtm will be followed for about 1 year. the health of their liver and gallbladder will be checked about every 6 weeks. this can be done at home, if preferred. a scan called a fibroscan (also known as transient elastography) will check for signs of scarring in the liver (fibrosis) and the build-up of lipids. it is suggested that each boy will have a fibroscan when they start the study and another scan when they complete the study. this study will help understand liver, gallbladder, and bile duct issues in individuals with xlmtm over time. the goal is to improve their care and provide information to use in future clinical studies.


Eligibility criteria:
inclusion criteria: * participant has a diagnosis of xlmtm resulting from a genetically confirmed mutation in the mtm1 gene based on genetic test reports. * participant requires some mechanical ventilatory support (e.g., ranging from 24 hours per day full-time mechanical ventilation, to non-invasive support such as continuous positive airway pressure (cpap) or bilevel positive airway pressure (bipap) during sleeping hours) * participant (as applicable) and/or parent(s) or legally authorized representative (lar(s)) is willing to comply with the recommended schedule of assessments. exclusion criteria: * participant is currently enrolled in an interventional study designed to treat xlmtm.

Keywords: xlmtm hepatobiliary
evaluation of pillcam® express capsule endoscopy delivery system

Conditions: Small Bowel Disease; Inflammatory Bowel Disease

Summary: the purpose of this study is to evaluate the safety and efficacy of a trans-endoscopic capsule placement capsule endoscopy delivery system.

natural ingestion of a wireless capsule endoscope (e.g. pillcam™ sb) is contraindicated in subjects with oropharyngeal or mechanical dysphagia, gastroparesis and known or suspected anatomical abnormalities. in addition, ingestion of a wireless capsule endoscope may be challenging in the pediatric population. the pillcam® express capsule endoscopy delivery system is intended to provide physicians with the capability to place capsules in the proximal duodenum using the accessory channel of a standard endoscope. the pillcam™ sb capsule to be used in this study was cleared by the fda in august 2001 for small bowel evaluation. it has been ingested to date by more than 1,000,000 people worldwide and is well accepted by subjects and physicians as well as the professional societies. further details of the pillcam®express capsule endoscopy delivery system can be found in the device description section. this study is designed to evaluate the performance and safety of the capsule endoscopy delivery system in subjects indicated to undergo a standard esophagogastroduodenoscopy (egd) endoscopy

Eligibility criteria:
inclusion criteria: * age ≥ 2 years * subject scheduled for egd endoscopy with a 2.8 mm (or greater) working channel exclusion criteria: * subject is known or is suspected to suffer from bowel obstruction or bowel perforation at the time of presentation * subject has history of ugi tract surgery (e.g., billroth i, billroth ii, esophagectomy, gastrectomy, bariatric procedure) * presence of an electro-medical device (pacemaker or internal cardiac defibrillator) * subject is pregnant * subject is expected to undergo a mri examination within 7 days after ingestion of the capsule * subject has known allergy to conscious sedation medications * subject or legal guardian is not able to provide written informed consent

Keywords: capsule endoscopy small bowel disease inflammatory bowel disease subjects indicated for egd endoscopy
a cone beam computed tomographic evaluation of healing of apicomarginal defects using autologous platelet aggregates

Conditions: Chronic Apical Periodontitis

Summary: this study will evaluate the effect of prf (platelet rich fibrin) on the healing of apicomarginal defects. healing of the defects will be assessed 2 dimensionaly by periapical radiograph and 3 dimensionaly using cbct.

patients with apicomarginal defects as per the inclusion criteria will be randomly divided into two groups - (1) test group - the denuded root surface will be covered by prf (choukron's method) and (2) control group -no use of autologous platelet aggregate during periapical surgery. radiographic and clinical healing will be assessed after 12 months, 2d healing will be assessed by rud and molven criteria and 3d healing will be assessed by modified penn 3d criteria.the clinical parameters recorded including periodontal pocket depth (pd), clinical attachment level (cal) and gingival margin position (gmp) will be measured on buccal aspect of the interproximal space and mid buccal aspect of the involved teeth using williams 'o' periodontal probe.routine examination procedure will be used to evaluate any evidence of signs and/or symptoms.

Eligibility criteria:
inclusion criteria: * a negative response to vitality tests with radiographic evidence of periapical radiolucency with no general medical contraindications for oral surgical procedures. * apicomarginal communication having probing depth \> 6mm. * patients with no general medical contraindications for oral surgical procedures. * recurrent episodes of purulent discharge. * failed previous root canal treatment. * failed previous surgery with persistent bony lesion. * adequate final restoration with no clinical evidence of coronal leakage. exclusion criteria: * clinical or radiographic evidence of root fracture. * resorptive processes involving more than apical third of the root. * any systemic disease contraindicating oral surgery including uncontrolled diabetes and pregnancy. * any condition effecting rate of healing like smoking.

Keywords: apicomarginal defects cone beam computed tomography autologous platelet aggregate
study of silverhawk®/turbohawk® in lower extremity vessels (definitive™ le)

Conditions: Peripheral Arterial Disease; Claudication; Critical Limb Ischemia

Summary: the purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs.


Eligibility criteria:
inclusion criteria * has a rutherford clinical category score of 1 - 6. * has evidence of ≥ 50% stenosis or occlusion in the superficial femoral, popliteal, anterior tibial, posterior tibial and/or peroneal arteries, confirmed by angiography. * has identifiable distal target vessel which upon completion of the intervention, is anticipated to provide re-constitution of blood flow to the foot. * exchangeable guidewire must cross lesion(s), with ability of catheter to cross lesion. * each discrete target lesion's length is ≤ 20 cm. * reference vessel diameter is ≥ 1.5 mm and ≤ 7 mm. exclusion criteria * has surgical or endovascular procedure of the target vessel within 14 days prior to the index procedure. * has any planned surgical intervention or endovascular procedure within 30 days after the index procedure. * has had a previous peripheral bypass affecting the target limb. * has end-stage renal disease defined as undergoing hemodialysis for kidney failure. * has presence of severe calcification in target lesion(s). * has in-stent restenosis of the target lesion. * has an aneurysmal target vessel. * has significant stenosis or occlusion of inflow tract that has not been revascularized prior to treatment of the target vessel. * has perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to enrollment. * has disease that precludes safe advancement of the silverhawk/turbohawk device to the target lesion(s). * has had a previous amputation above the metatarsal line on the target limb.

Keywords: pad
treat to target trial in axial spondylo arthritis : the ticospa (tight control in spondyloarthritis)

Conditions: Axial Spondyloarthritis

Summary: this is a not interventional, pragmatic, prospective, randomized (cluster) study to evaluate the potential benefit of a treat to target approach in comparison to routine treatment (i.e. usual care) in patients with axial spondyloarthritis.

this study is reflecting the usual care either in accordance to the treating rheumatologist (arm: usual care) or in accordance to the international scientific recommendations (arm: t2t) the tight control means that as soon as a treatment is initiated in a patient, the time permitting to evaluate its potential efficacy/safety has to be determined. in terms of safety, such time frame can be very short based on the occurrence of adverse events. in terms of efficacy it is usually recommended to evaluate an nsaids after 2 to 4 weeks of treatment intake and the tnf blockers after 12 to 16 weeks. the treat to target means that there is an a priori decision of the target to reach while initiating a treatment and more importantly an a priori decision to intensify the treatment in case such target is not achieved. there will be 2 arms in the study (tight control and treat to target arm and usual care arm). 160 patients (80 patients per arm) will be included during one year by 18 centers (10 in france, 4 in belgium and 4 in netherlands). patients will be followed during 1 year.

Eligibility criteria:
inclusion criteria: * adults (between 18 and 65 years old) * with a diagnosis of axial spondyloarthritis according to the axial asas criteria and the opinion of the treating rheumatologist. * active disease defined as an asdas ≥ 2.1 * predominant axial disease meaning that: * patients with non-spinal rheumatological symptoms and/or extra-rheumatological manifestations requiring at baseline the initiation of a specific treatment will be excluded. * patients with a past history and/or a current well controlled non-spinal rheumatological or extra-rheumatological features will be eligible for the study. * non-optimally treated with nsaids (i.e. who have not received at least 2 nsaids, daily during at least 2 weeks at full dose, during the last year). annex ii summarizes the list of commonly used nsaids and the definition of a "full" use. * with available pelvic x-rays, b27 and mri of the sacro-iliac joints (performed at any time since symptoms onset) * with no contraindication to the use of a nsaid * with no intake of apremilast during the previous 3 months * able to understand the objectives of the study and to fill the questionnaires * written informed consent.

Keywords: treat to target approach
hemodynamic optimisation guided with transcranial doppler in septic shock

Conditions: Trans Cranial Doppler Ultrasonography in Heamodynamic Optimisation in Septic Shock

Summary: randomized, controlled, prospective trial, including icu patients with sepsis or septic shock, at the early phase. patients will be randomized in 2 groups regarding the hemodynamic management and catecholamin doses: * group 1: standard hemodynamic goals and catecholamin infusion to achieve: mean arterial pressure \> or equal to 65 mmhg and diastolic arterial pressure \> ou equal to 50 mmhg within the first 60 minutes. * group 2: personalized hemodynamic goals and catecholamin infusion until normal transcranial doppler: ip\<1,2.

randomized, controlled, prospective trial, including icu patients with sepsis or septic shock, at the early phase. patients will be randomized in 2 groups regarding the hemodynamic management and catecholamin doses: * group 1: standard hemodynamic goals and cathecolamin infusion to achieve: mean arterial pressure \> or equal to 65 mmhg and diastolic arterial pressure \> ou equal to 50 mmhg within the first 60 minutes. * group 2: personalized hemodynamic goals and cathecolamin infusion until normal transcranial doppler: ip\<1,2. for the 2 groups, standard management including: microbiological sampling, early broad spectrum anti infective therapy, fluid management and decreasing of blood lactate levels, will be aimed within the first 60 minutes. for the group 2 patients: personalized hemodynamic management will be maintained during 72 hours.

Eligibility criteria:
inclusion criteria: * all icu patients presenting septic shock * no criteria of traumatic or vascular brain injury exclusion criteria: * patients with refractory septick shock * rapid fatal evolution: before 72 hours * no individualisation of the mca ultrasonographic window

Keywords: trans cranial doppler ultrasonography, hemodynamics, septic shock, sepsis associated encephalopathy
frequency and presentations of chronic pain following breast cancer surgery: an observational study in a tertiary care hospital of pakistan

Conditions: Breast Cancer Female; Chronic Pain

Summary: this study is designed to evaluate the frequency and presentations of chronic persistent pain in patients after breast cancer surgery at our tertiary care hospital. results of this study will help us to understand the magnitude of problem in our population and making institutional guidelines for appropriate management of such patients.

after approval from the departmental research committee and institutional ethical review committee all adult female patients with known carcinoma of breast who are scheduled for elective definitive breast cancer surgery (mastectomy) from 1st july 2016 to 30th december 2016 will be enrolled in this audit. inclusion of patients will be done once operative procedure is finalized and consent taken in breast clinic. those patients who did not give consent and those patients who need reoperation on same side for recurrence of cancer or any reason will be excluded from this study. data will be obtained from patient's medical record, interview of patient on follow up visit at breast clinic and telephonic communication with patient. variables have been defined and a special form has been designed for data collection. all patients will be followed for next three months and those who have persistent pain will be followed for six months after operation. follow up information will be obtained from patient visiting breast clinic. for any missing data patient's medical records will be reviewed and patient will be contacted to know if they have chronic post-surgical pain or not. audit forms will be filled by authors according to their availability. the primary investigator or author at breast clinic will keep all forms for safe record keeping which shall later be used for data analysis.

Eligibility criteria:
inclusion criteria: * all adult female patients with known carcinoma of breast who are scheduled for elective definitive breast cancer surgery (mastectomy) exclusion criteria: * those patients who did not give consent and those patients who need reoperation on same side for recurrence of cancer or any reason will be excluded from this study.

Keywords: breast cancer surgery persistent pain
intracanal dexamethasone extrusion and postoperative endodontic pain

Conditions: Post Operative Pain Control; Endodontic Treatment

Summary: the aim of this research is to assess the effect of intentionally extruding a corticosteroid intracanal solution into the periapical tissues on the postoperative pain after root canal treatment in patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis (sip/sap). the main question it aims to answer: is there an analgesic effect of extruding an intracanal solution of dxa into the periapical tissues in patients diagnosed with sip/sap? researchers will compare dexamethasone to a placebo to see if the extrusion dexamethasone works in reducing post-endodontic treatment pain.


Eligibility criteria:
inclusion criteria: * a diagnosis of irreversible pulpits with symptomatic apical periodontitis * adult patients (aged 18 - 70) * healthy patients or those with a well-controlled disease (asa i \& ii) exclusion criteria: * a diagnosis of necrotic pulp, or normal apical tissues * patients with a severe systemic disease (asa iii or higher) * patients who received analgesics12 hours before presentation * previously treated/initiated endodontics treatment on the same tooth * unopposed teeth * third molar teeth * non-restorable teeth * periodontally compromised teeth * pregnant or lactating patients

Keywords: root canal treatment post-operative pain corticosteroids dexamethasone randomised controlled trial
neuroinflammation in amyotrophic lateral sclerosis - mechanisms and therapeutic perspectives: a translational pilot study among als patients

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Summary: amyotrophic lateral sclerosis (als) is the most common motor neuron diseases. it is considered as a rare disease with a prevalence of about 8 per 100,000 persons. initiating in mid-life by progressive paralysis, it evolves rapidly into a generalized muscle wasting that leads irrevocably to death within 2 or 5 years of clinical onset. since there is no cure for als, the management of the disease is supportive and palliative. riluzole is the only drug that has been shown to extend survival by about three months. the identification of biomarkers sensitive to the progression of the disease might enhance the diagnostic and provide new drug targets. dysfunction of the immune system is a pathological hallmark of als. increased levels of interferon gamma (ifngamma) were found in the serum and cerebrospinal fluid (csf) of als patients. however, the cell origin as well as the pathogenic influence of this peripheral source of ifng is unknown. thus, ifngamma might have a role in the pathogenic process of als and might be a potential biomarker of the disease.


Eligibility criteria:
inclusion criteria: group 1 and group 2: * with sporadic als (without family history), recently diagnosed (onset of first symptoms \ 24 months) group 2 * who meet the laboratory-supported probable, probable or definite form of als according to the el escorial criteria * suffering from the spinal form of als group 3: - with an inflammatory peripheral neuropathy, or a non inflammatory peripheral neuropathy, recently diagnosed exclusion criteria: * familial form of als * bulbar form and respiratory onset form of als * subjects with a clinically significant history of unstable or severe cardiac, oncologic, hepatic or renal disease, or other medically significant illness. * subjects with significant cognitive impairment, clinical dementia, or psychiatric illness. * female of childbearing potential (apart of patient using adequate contraceptive measures), pregnant or breast feeding * suspected inability to complete the study follow-up (foreign workers, transient visitors, tourists or any others for whom follow-up evaluation is not assured) * participation in any other clinical study within 30 days prior to the screening visit * persons deprived of freedom by judicial or administrative decision, hospitalized without their consent or for other reasons than the research, under legal protection or unable to express their consent
immunogenicity of a reduced primary schedule for pneumococcal conjugate vaccine in uk infants

Conditions: Streptococcus Pneumoniae

Summary: the purpose of the trial is to determine the minimum of doses of a new nine valent pneumococcal conjugate vaccine required to protect uk infants and toddlers

a new vaccine against pneumococcal infection is now available in the uk and has already been in routine use in the us for five years. the purpose of the trial is to determine the minimum number of does required to protect uk infants and toddlers, and to assess the compatibility of the pneumococcal vaccine with the other vaccines given in the uk childhood immunisation programme. the vaccine used in the us protects against seven strains of pnemococcus whereas the vaccine used in this trial protects against nine strains. infants received either two doses at two and four months or three doses at two, three and four months of age, the latter comprising the routine infant schedule for other paediatric vaccines in the uk. the infants also received the usual vaccines against diphtheria , tetanus, polio, whooping cough and hib together with meningitis c vaccine which is currently only used in the uk and a few other countries worldwide. a group of toddlers aged twelve to fifteen months also took apart and received either one or two doses of pneumococcal vaccine around the same time as their mmr vaccine. all children in the study received a booster dose some months later. the response to the vaccine is assessed by measuring levels of protective antibodies to the pneumococcal strains in blood samples taken at various times during the immunisation schedule.

Eligibility criteria:
inclusion criteria: * informed consent by parent/guardian for receipt of study vaccines and for blood samples * age at first dose: infants 7-11 weeks; toddlers 12-18 months exclusion criteria: * previous bacteriologically confirmed pneumococcal or meningococcal disease * contraindications for pneumococcal, meningococcal, hib, dtp, mmr immunisations as listed in the uk handbook, "immunisation against infectious disease" edition 1996. * language difficulty in parents sufficient to preclude adequate comprehension of the information sheet, consent form and study nurses' explanation of the study * children participating in any other clinical trial * immunocompromised * acute systemic illness or fever \> 38c on day of vaccination - deferral