Kornimate/medical-research-clean huggingface dataset:
efficacy of pain control in different bupivacaine dose in periarticular injection in bilateral total knee arthroplasty

Conditions: Bilateral Total Knee Arthroplasty

Summary: to study efficacy of postoperative pain control of different concentrations of bupivacaine for periarticular infiltration, part of multimodal analgesia, in bilateral total knee arthroplasty. to study plasma concentration of bupivacaine in patient who received spinal anesthesia and single shot bilateral adductor canal block and periarticular infiltration with bupivacaine for safety level.

adequate postoperative pain control reduce postoperative morbidity, multimodal analgesia techniques is used for achieve this goal. multimodal analgesia for bilateral total knee arthroplasty are peripheral nerve block, periarticular infiltration, nsaids, gabapentins and others. patients undergoing bilateral total knee arthroplasty in siriraj hospital receive spinal anesthesia, single shot bilateral adductor canal block and bilateral periarticular infiltration with bupivacaine so patient receive a large dose of bupivacaine. the investigators study the efficacy of postoperative pain of reduced dose of bupivacaine for periarticular infiltration. and study plasma level of bupivacaine.

Eligibility criteria:
inclusion criteria: * aged more than 18 years old * american society of anesthesiologists physical status classification 1-3 * undergoing bilateral total knee arthroplasty with spinal anesthesia and single shot bilateral adductor canal block exclusion criteria: * allergy to bupivacaine * body weight less than 50 kilograms * hepatic disease * coagulopathy * creatinine clearance less than 60 ml/min * uncontrolled cerebrovascular disease * hematocrit less than 35%

Keywords: periarticular infiltration postoperative pain management plasma level of bupivacaine
a study of 123i-cmice-013 radiopharmaceutical in healthy volunteers

Conditions: Coronary Artery Disease

Summary: the need exists for alternatives to 99mtc based perfusion radiotracers for cardiac patient management. an alternative radiotracer, i123-cmice-013, has been developed at the canadian molecular imaging center of excellence (c-mice) at the university of ottawa heart institute. initial testing results in rats and pigs suggest that in addition to being a cyclotron-produced alternative to 99mtc tracers, i-123-cmice-013 may be a superior tracer for measuring myocardial perfusion.this phase 1 study will study the safety and tolerability, biodistribution, pharmacokinetics and radiation dosimetry, and distribution and localization of i123-cmice-013in healthy adult volunteers.

single photon emission computed tomography (spect) myocardial perfusion imaging (mpi) is an established, cost effective tool for the risk stratification and management of patients suspected or known to have coronary artery disease (cad)myocardial perfusion imaging is significantly affected by interruptions in the supply of 99mmo, the parent isotope of 99mtc used for the majority of mpi. an alternative radiotracer, i123-cmice-013,developed at the canadian molecular imaging center of excellence (c-mice) at the university of ottawa heart institute, has completed pre-clinical trial testing and is ready for phase 1 human trials. this phase i study will be a single centre, open label study. subjects will receive 2 doses of study drug. one rest dose and one stress dose will be administered on separate days, one week apart. subjects will undergo a standard clinical exercise stress protocol for the stress dose. gamma camera imaging following each administration will be done over 2 days. biodistribution, pharmacokinetics, dosimetry and safety variables will be analyzed.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 65 years 2. no significant medical history 3. normal physical exam 4. bmi ≤ 30 kg/m2 5. no current use of prescription medication 6. no clinically significant abnormalities in baseline laboratory work 7. no clinically significant abnormalities in baseline 12 lead electrocardiogram 8. female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening exclusion criteria: 1. pregnancy 2. known hypersensitivity to the investigational drug or any of its components 3. claustrophobia or inability to lie still in a supine position 4. unwillingness to provide informed consent

Keywords: myocardial perfusion imaging single photon emission tomography coronary artery disease gamma camera imaging phase 1 clinical trial cyclotron
post-market data collection to evaluate the performance of the synergy disc®

Conditions: Cervical Degenerative Disc Disease

Summary: this is a real world data collection observational study at a single site. there are both prospective and retrospective cohorts. the study will examine the safety and effectiveness of the synergy cervical disc system in patients with degenerative cervical disc disease.


Eligibility criteria:
inclusion criteria: age 21 or above at the time of the surgery. have had (retrospective cohort) or the decision has been made to have (prospective cohort) the synergy disc implanted skeletally mature patients for reconstruction of the disc from c3-c7 following a single or multiple level discectomy for intractable radiculopathy intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression: herniated disc and/or osteophyte formation symptomatic nerve root and/or spinal cord compression documented by patient history (arm or neck pain and/or neurologic deficit) and imaging (ct, mri, x-rays, etc.) failed a minimum of 6 weeks conservative treatment written informed consent given by subject. exclusion criteria: exclusion criteria: all answers must be no to be eligible for the study. moderate to advanced spondylosis diagnosis of osteoporosis active systemic infection or infection at the operative site pregnancy marked cervical instability on lateral, coronal, or flexion/extension radiographs cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level severe pathology of the facet joints of the involved vertebral bodies previous diagnosis of osteopenia or osteomalacia more than one immobile vertebral level between c1 and t1 from any cause morbid obesity vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity)
once-daily investigational nasal spray in adults and adolescents with seasonal allergic rhinitis (sar)

Conditions: Rhinitis, Allergic, Seasonal

Summary: allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. the focus of this study, seasonal allergic rhinitis (sar), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. commonly referred to as (hay fever), it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes. the primary objective of this study is to compare the efficacy and safety of gw685698x 100mcg once daily (qd) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with seasonal allergic rhinitis (sar) caused by ragweed pollen.

a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of once-daily, intranasal administration of gw685698x aqueous nasal spray 100mcg for 2 weeks in adult and adolescent subjects (12 years of age and older) with seasonal allergic rhinitis (sar)

Eligibility criteria:
inclusion criteria: * must be outpatients. * diagnosis of sar. * literate in english or native language. exclusion criteria: * have a significant concomitant medical condition. * use corticosteroids or other allergy medications during the study. * use tobacco products.

Keywords: seasonal allergic rhinitis gw685698x allergic rhinitis hayfever
weight bearing exercises with and without jaffrey's core stability exercise training in children with down syndrome.

Conditions: Down Syndrome

Summary: down syndrome also known as trisomy 21, is a genetic disorder caused by the presence of all or part of a third copy of chromosome 21. it is usually associated with physical growth delays, mild to moderate intellectual disability, and characteristic facial features. there is no cure for down syndrome. education and proper care have been shown to improve quality of life. some children with down syndrome are educated in typical school classes, while others require more specialized education. those with down syndrome nearly always have physical and intellectual disabilities. they also typically have poor immune function and generally reach developmental milestones at a later age. they have an increased risk of a number of other health problems, including congenital heart defect, epilepsy, leukemia, thyroid diseases, and mental disorders. this study will determine effects of weight bearing exercises with and without jaffery's core stability exercise training on dynamic balance and trunk muscles strength in children with down syndrome. randomized controlled study will be conducted in which data will be collected from children with down syndrome with calculated sample size of 18 which will randomly assigned into group a and group b. group a would receive weight bearing exercises (i.e. standing on preferred foot, standing with close eyes, walking forward on a line using normal stride and heel to toe gait, stepping over response speed stick on balance beam ).group b would receive weight bearing exercises along with the jaffrey's core stability exercises (i.e. contracting muscles, sitting on swiss ball, bridging, squatting side lying bridge etc.).frequency will be 5 sessions per week, of 1 hour and duration is of 5 months. balance and trunk muscle strength will be pre assessed using pediatric balance scale and trunk control measurement scale respectively. the improvement will be measured with same tools. data will be analyzed through spss 25.


Eligibility criteria:
inclusion criteria: * children with medical diagnosis of ds * age ranging from 4 to 10 year * both male and female genders * children who was able to stand and walk. exclusion criteria: * any orthopedic limitation to exercise such as hip, knee, foot or spinal deformity. * children with planned orthopedic surgery in 6 months. * children with significantly impaired cognition. * children with hearing impairment
compare the effects of agility and cycling exercise training on mobility and balance in pd and healthy old adults

Conditions: Healthy; Movement Disorders; Parkinson Disease; Condition

Summary: the purpose of the study is to compare the effectiveness and specificity of agility and cycling exercise training on balance and mobility outcomes in pd and age and gender matched healthy controls. the hypothesis is that due to being profoundly deconditioned, agility and cycling will be similarly effective in pd but agility will be more effective then cycling in healthy old adults, in improving mobility and balance.


Eligibility criteria:
inclusion criteria: * family doctor should be qualified as healthy. * older adults had to have basic fitness * weekly movement of at least 3 hours exclusion criteria: * severe heart problems * severe demeanor * alcoholism * drug problems

Keywords: balance postural controll motor controll posturgraphy quality of life
the power of hand reflexology in ameliorating anxiety, pain, and fatigue among patients undergoing coronary angiography

Conditions: Coronary Artery Disease

Summary: reflexology influences pain perception and pain-impulse transmission by releasing endorphins (12). patients with a variety of medical illnesses can benefit from hand reflexology by lessening their physical and emotional discomfort (13, 14). therefore, this study was done to investigate the power of hand reflexology in ameliorating anxiety, pain, and fatigue among patients undergoing coronary angiography


Eligibility criteria:
criteria: inclusion criteria: * patients between the ages of 20 and 60 who were scheduled for non-emergency ca, absence of any hands' sensory motor disorders, or upper limb vascular injuries. * no abnormalities such as amputations, burns, skin lesions, and intervertebral disc herniation. * no history of mental illnesses. exclusion criteria: patients with severe mental problems
glycaemic control and other clinical parameters in adult type 2 diabetes patients on basal insulin initiating treatment with ideglira in routine clinical practice in colombia

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to investigate the glycaemic control and other clinical parameters in adult patients previously treated with basal insulin (with or without oads) and switched to ideglira in real-world clinical practice in colombia.


Eligibility criteria:
inclusion criteria: 1. male or female, age above or equal to 18 years at the time of data collection. 2. patient diagnosed with t2d greater than or equal to 12 months prior to data collection. 3. the decision to initiate treatment with commercially available ideglira has been made by the patient and the treating physician before, which is independent from the decision to participate in this study. 4. treated with basal insulin plus/minus oads prior to initiating ideglira. 5. available and documented hba1c measurement below or equal to 12 weeks prior to ideglira initiation. exclusion criteria: 1. mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. 2. diagnosed with type 1 diabetes mellitus, maturity-onset diabetes of the young, latent autoimmune diabetes in adults, gestational diabetes or any hyperglycaemic state other than t2d. 3. women known to be pregnant or breastfeeding during the conduct of the study. 4. patients with basal-bolus insulin prior to ideglira initiation. 5. participation in another t2d clinical study that involves any clinical intervention or administration of an investigational drug within 3 months prior to initiating ideglira.
simultaneous modulated accelerated boost versus standard dose radiotherapy in esophageal cancer

Conditions: Esophageal Cancer

Summary: this randomized phase iii trial is to compare simultaneous modulated accelerated boost with standard dose radiotherapy given together with chemotherapy in treating patients with esophageal squamous cell carcinoma.


Eligibility criteria:
inclusion criteria: * histologic proof of primary squamous cell carcinoma of the esophagus. * primary disease at cervical, upper or middle thoracic esophagus * t1-4, n any, m0 (except supraclavicular lymph node). * age≥18 \& ≤75. * ecog score 0-2. * platelets ≥ 150,000, hgb ≥ 10 gm%, anc ≥ 1500, serum creatinine ≤ 1.5 mg/dl. * adequate liver function. * patients with prior malignancy are eligible if disease-free ≥ 5 years. * no prior chest radiotherapy, systemic chemotherapy or major esophageal surgery. * signed study-specific informed consent form prior to study entry. exclusion criteria: * patients with tracheo-esophageal fistula. * patients with invasion into mucosa of trachea or major bronchi. * patients with uncontrolled serious medical or mental illnesses. * prior rt that would result in overlap of planned rt fields. * pregnancy or women of childbearing potential and men who are sexually active * women who are breastfeeding a baby.

Keywords: esophageal cancer simultaneous modulated accelerated boost standard dose radiotherapy chemotherapy survival
analysis of long term risk of coronavirus disease-19 emergency

Conditions: Lifestyle; Dietary Habits; Psychosocial Problem

Summary: the aim of this study is to investigate dietary, lifestyle and psychosocial changes possibly occurred during italy's lockdown, that is in the period of time between march 9 2020 and may 3 2020 (hereafter referred to as the phase 1 lockdown) in two different populations: the moli-sani study cohort and the italian general population.

the containment measures released by the italian government for the period between march 9- may 3 2020 have been aimed to reduce the movement of people from their homes, which was only allowed in cases of special need, and the use of smart work (working from home) wherever possible .as a consequence, the lockdown period is likely to have lasting effects on people and their lifestyles, especially nutrition, and psychosocial well-being. a web-based questionnaire was developed to retrospectively investigate dietary, lifestyle and psychosocial changes possibly occurred during italy's lockdown, that is in the period of time between march 9 2020 and may 3 2020 (hereafter referred to as the phase 1 lockdown). the potential impact of phase 1 lockdown on lifestyles will be tested in two distinct population cohorts, that is the moli-sani study cohort (established among residents in the molise region in the period 2005-2010) and a sample of the general italian population, aged ≥ 18 years.

Eligibility criteria:
inclusion criteria for the moli-sani study sub-cohort: * re-examination in 2017-2020; * able to give verbal consent exclusion criteria for the moli-sani study sub-cohort: - not able to give verbal consent inclusion criteria for the general italian population cohort: * age \>= 18 years. * all subjects from the general population with access to electronic devices and the internet (e.g. personal computer, smartphone) and is fluent in italian will be eligible. exclusion criteria for the general italian population cohort: * subjects younger than 18 years * only people with access to personal computers, smartphones and the internet, and fluency in italian will be able to participate. these exclusions are not based on age, gender, pregnancy, racial, or ethnic origin.

Keywords: pandemic lockdown lifestyles dietary habits psychosocial factors
chlorthalidone and hctz impacts on platelet activation

Conditions: Hypertension

Summary: this will be a randomized, double-blinded, three-period crossover study of platelet activation and aggregation in 30 non-smoking healthy volunteers comparing chlorthalidone (ctd), hydrochlorothiazide (hctz), and aspirin (asa; active control). the study hypothesis is that ctd has different effects on platelet activation and aggregation than hctz.


Eligibility criteria:
inclusion criteria: * men or women age 19 or older * not currently taking any routinely scheduled prescription or over the counter medications or herbal supplements * no use of aspirin, clopidogrel, prasugrel, ticagrelor, cilostazol, dipyridamole, nsaid medications, or herbal supplements within the previous 7 days and able to refrain from use during the study period * systolic blood pressure \> 110 mmhg and diastolic blood pressure \> 60 mmhg * non-smoker exclusion criteria: * previous adverse reaction or allergy to hctz, ctd, or asa * severe sulfonamide hypersensitivity (anaphylaxis or stevens-johnson syndrome) * diagnosis of any chronic disease or condition * history of gout or hyperuricemia * history of pancreatitis * history of systemic lupus erythematosus (sle) * history of hypokalemia requiring treatment * pregnant or planning to become pregnant during the study period * breastfeeding * history of hypotension * history of gastrointestinal bleeding

Keywords: hypertension platelet activation platelet aggregation chlorthalidone
the efficacy of readiness and motivation therapy in individuals with anorexia nervosa and bulimia nervosa

Conditions: Anorexia Nervosa; Bulimia Nervosa

Summary: this research examines the efficacy of a 5-session individual psychotherapy intervention designed to enhance readiness and motivation for change in individuals with anorexia nervosa, bulimia nervosa, and eating disorder not otherwise specified. it is hypothesized that individuals randomly assigned to receive readiness and motivation therapy (rmt) will have higher readiness and motivation scores and improved eating disorder and psychiatric symptomatology following the intervention than individuals assigned to a no-treatment control condition.

readiness and motivation for change is a significant concern in the treatment of individuals with eating disorders, as evidenced by frequent treatment drop-out, refusal, and relapse. this research examines the efficacy of a 5-session intervention designed to enhance readiness and motivation for change in individuals with anorexia nervosa. a manualized treatment protocol of readiness and motivation therapy (rmt) has been developed. it is hypothesized that individuals randomly assigned to rmt will have improved readiness and motivation for change as assessed using the readiness and motivation interview (rmi) at post-treatment, 3-month, and one-year follow-up than individuals assigned to a no treatment control condition. if rmt proves to be effective, it could be added to the menu of treatment options, to permit for better tailoring of treatment to client readiness for change.

Eligibility criteria:
inclusion criteria: * meet dsm-iv diagnostic criteria for anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified exclusion criteria: * acute medical crisis * acute psychiatric crisis

Keywords: anorexia nervosa bulimia nervosa readiness and motivation
a study of ro5428029 in healthy volunteers and patients with chronic hepatitis c

Conditions: Hepatitis C, Chronic, Healthy Volunteer

Summary: this 2-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of ro5428029 in healthy volunteers and patients with hepatitis c infection. cohorts will be randomized to receive either ro5428029 in ascending doses or placebo for up to 7 days (patients) or up to 14 days (healthy volunteers).


Eligibility criteria:
inclusion criteria: * healthy subjects (part a) or patients with chronic hepatitis c infection (part b), 18 to 60 years of age, inclusive * body mass index (bmi) between 18 and 32 kg/m2, inclusive, and a minimum weight of 45 kg * female subjects/patients must be surgically sterile or post-menopausal * male subjects/patients and their partners of childbearing potential must use 2 methods of contraception * for hcv patients: * hepatitis c genotype 1 of \> 6 months duration at screening * hcv rna quantifiable (roche cobas taqman hcv test) at screening * hcv treatment-naïve (no prior antiviral therapy for chronic hepatitis c with interferon-based therapy) * liver biopsy or non-invasive procedure within the past 2 years showing absence of cirrhosis exclusion criteria: * pregnant or lactating women, and male partners of women who are pregnant or lactating * positive test for drugs of abuse * history (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams or 1 unit of alcohol * history or symptoms of any significant disease or disorder * history of active malignancy within the last 5 years, except for localized or in situ carcinoma (e.g. basal or squamous cell carcinoma of the skin) * positive for hepatitis b or hiv infection, and/ or for hcv for healthy volunteers (part a) * for hcv patients: * decompensated liver disease or impaired liver function as defined by any history of ascites, hepatic encephalopathy, hepatocellular carcinoma or bleeding esophageal varices, or prothrombin international normalized ratio (ptinr) \>/= 2.0 at screening * evidence of cirrhosis and/or incomplete transition to cirrhosis * presence or history of non-hepatitis c liver disease