Kornimate/medical-research-clean huggingface dataset:
v260 study: concomitant use of v260 and infanrix™ hexa in healthy infants (v260-010)

Conditions: Rotavirus Disease

Summary: the study is being conducted to demonstrate that the vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with infanrix(tm)hexa without impairing the safety and immunogenicity of either vaccine.


Eligibility criteria:
inclusion criteria: * healthy infant per investigator, 6 through 12 weeks of age exclusion criteria: * history of congenital abdominal disorders, intussusception, or abdominal surgery * known or suspected impairment of immunological function * known hypersensitivity to any component of the rotavirus vaccine * prior administration of any rotavirus vaccine * known hypersensitivity or contraindication to any component of infanrix(tm) hexa * any infant born from a known hbsag-positive mother * prior administration of any oral polio vaccine * receipt of one or more doses of inactivated poliovirus vaccine, diptheria, tetanus and acellular pertussis vaccine, diptheria, tetanus and pertussis vaccine, haemophilus influenzae type b vaccine, or any hepatitis b vaccine prior to the first vaccination, or receipt of any vaccines with these antigens at any time during the course of the study * fever, with a rectal temperature greater than or equal to 38.1 degree c (greater than or equal to 100.5 degree f) at the time of immunization * history of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive * clinical evidence of active gastrointestinal illness * receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 2 weeks prior to vaccination * infants residing in a household with an immunocompromised person * prior receipt of a blood transfusion or blood products * participation in another clinical study within 42 days before the beginning or anytime during the duration of the current clinical study * any infant who cannot be adequately followed for safety by a contact visit * history of seizure disorders or prior history followed for safety by a contact visit * any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives
immunogenicity and safety of a novel adjuvanted hbv vaccine in pre-liver transplant patients 18 years of age

Conditions: Hepatitis B

Summary: the purpose of this study is to enroll pre-liver transplant patients who will be vaccinated with either the novel adjuvanted hbv vaccine or double doses of engerix™-b. the immunogenicity and safety of the novel adjuvanted vaccine will be compared to engerix™-b as the control vaccine

at the time of conduct of this study, the sponsor glaxosmithkline was known by its former name smithkline beecham

Eligibility criteria:
inclusion criteria: * a male or female ≥ 18 years of age at the time of the first vaccination. * written informed consent obtained from the subject. * seronegative for anti-hbs-antibodies, anti-hbc-antibodies \& hbsag. * if the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. * documented case of liver failure, such that the patient will require an eventual liver transplant exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine. * planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after. * previous vaccination against hepatitis b (whether or not a non-responder to vaccination). * previous vaccination with an adjuvant system containing mpl®. * history of hepatitis b infection. * known exposure to hepatitis b virus within 6 weeks. * previously confirmed human immunodeficiency virus (hiv) infection. * a family history of congenital or hereditary immunodeficiency. * immunosuppression caused by the administration of parenteral steroids or chemotherapy. * suspected or confirmed multiple sclerosis in the subject (applicable to centres 011, 012, 013 and 014/ france only). * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * acute, intercurrent disease at the time of enrollment. * oral/axillary temperature of ≥ 37.5°c (≥ 99.5°f). * administration of immunoglobulins and/or any blood products within one month preceding the first dose of study vaccine or planned administration/ administration during the study period. * pregnant or lactating female

Keywords: hepatitis b adjuvanted hepatitis b vaccine
deep brain stimulation in forel's h field in tourette's syndrome

Conditions: Tourette Syndrome

Summary: tourette's syndrome (ts) is a neurodevelopmental disease characterized tics that start before the age of 18 years. about 5% of cases do not respond to drug treatment and can be classified as refractory and in these cases surgical treatment, with deep brain stimulation, appears as a therapeutic possibility, but with still conflicting results. our hypothesis is that dbs in forel's h field could improve tourette's symptoms, neurological and psychiatric ones.

sixteen patients with ts will be included in our protocol. the tics must have a negative influence in the quality of life of these patients. patients will be submitted to a neuronavigation protocol for the precise location of the surgical target. after the surgery all patients will have the device turned on for 6 months. after the first 6 months participants will be randomly in two groups, one to stay with device on or turned off at a period of 3 months. after that the groups will cross over for more 3 months. clinical and video evaluations will be conducted before the surgery, at end of open fase, in the moment of cross over and at end of all.

Eligibility criteria:
inclusion criteria: * patients with tourette's syndrome diagnosis. * age equal to or above 14 years. * severe impairment of motor tics (yale global tic severity scale ≥ 35/50). * patients who are refractory to drug treatment. * patients intellectually able to understand and sign the consent form. * possibility to adhere to research and periodic medical visits after surgery. exclusion criteria: * inability to consent to your participation in the study. * patients with non-stabilized psychiatric comorbidities, such as anxiety and depression. * concomitant treatment with other experimental drugs. * women who are pregnant or breastfeeding. * patients undergoing previous neurosurgical procedures for the treatment of tourette's syndrome.

Keywords: dbs deep brain stimulation tourette syndrome
the thermogenic and metabolic effects of a whole food meal versus its supplemental equivalent

Conditions: Weight Loss

Summary: there is limited research on the amount of calories burned and metabolic differences of a complete supplemental meal in comparison to a whole food meal. the purpose of this study is to analyze the differences in calories burned and metabolic response post-consumption of a meal consisting of whole foods compared to its nutritionally engineered equivalent. investigators hypothesize that energy expenditure and satiety will be greater following consumption of the whole food meal compared to the supplement meal, whereas, there will be no difference in levels of glucose between the two conditions.

over 50% of u.s. adults today use some form of dietary supplementation to obtain their nutrient intake. previous research has shown that certain nutritional supplements may produce varying metabolic and thermogenic (calories burned) responses, when compared to other food sources. the difference in thermogenic response may also suggest that there is a difference between a whole food meal and its supplemental equivalent. if there is a difference in thermogenic response, this may indicate that a meal-replacing supplement, such as a ready-to-drink-shake and/or food bar may not induce the same health benefits as a whole food meal in terms of nutrient digestion, absorption, metabolism and storage. there has not been extensive research on the thermic effect and metabolic differences of a complete supplemental meal in comparison to a whole food meal. the purpose of this study is to analyze the differences in thermogenic and metabolic response post-consumption of a meal consisting of whole foods compared to its supplemental, engineered equivalent. it's hypothesized that energy expenditure and satiety will be greater following the whole food meal compared to the supplement meal, whereas, there will be no difference in levels of glucose between the two conditions.

Eligibility criteria:
inclusion criteria: * young healthy females exclusion criteria: * participants with specific dietary needs. * those with diabetes, impaired fasting glucose, low blood sugar (hypoglycemia) and participants who are classified as high risk. * participants with lactose intolerance. * participants who regularly use dietary supplements.
building capaciti for community-based palliative care

Conditions: Palliative Care

Summary: the purpose of this cluster randomized controlled trial is to assess the efficacy of a quality improvement intervention called capaciti intended to increase competency among primary care teams to deliver early palliative care. capaciti is palliative care training and coaching program for primary care teams, comprised of three, two-month (4 session) modules, each addressing a critical component of implementing a palliative care approach into primary care practice.

improving access to home-based palliative care can improve patient and system outcomes; however, there is a lack of programs to build capacity among primary care teams to deliver this care. to address this gap, the investigators are offering a quality improvement intervention called capaciti. capaciti is palliative care training and coaching program for primary care teams, comprised of three, two-month (4 session) modules. each module addresses a critical component of implementing a pc approach into primary care practice: (1) identify and assess; (2) enhance communication skills; (3) enhance skills for ongoing care (including involvement of family and specialists). over bi-monthly (one hour) sessions, each capaciti module uniquely integrates 3 components: clinical education in the form of expert advice and tips; evidence-based tools; and high-facilitation and expert coaching for adaptation to local context. the study will offer the capaciti modules to primary care teams across canada. teams that register for a module will be randomized to one of two arms: 1) facilitated learning where the module materials are covered in live webinars, and 2) non-facilitated learning where teams have access to all module materials to use a self-directed approach. the online materials for both study arms will be provided on a learning management system. the investigators will examine the difference between the facilitated and nonfacilitated approaches in teams' abilities to provide a palliative care approach in relation to the content of the module. ultimately this research program will strengthen the primary care system and increase access to home-based palliative care for patients across canada.

Eligibility criteria:
inclusion criteria: * each team must be comprised of primary care providers, defined as having a minimum of at least 1 of the following: family physician, nurse practitioner, or nurse and practice coordinator (including manager or administrator) that provides primary care. teams can be a single provider. teams can also have other team members (e.g. social worker, pharmacist, etc.). * each team must be community-based and willing to provide palliative care, defined as managing symptoms, addressing psychosocial needs, educating patients and families, and coordinating care. exclusion criteria: * not community-based * not willing to provide palliative care * outside of canada

Keywords: palliative care capaciti end of life primary care early identification
extracorporeal photopheresis in patients with bronchiolitis obliterans syndrome (bos) after lung transplantation

Conditions: Bronchiolitis Obliterans

Summary: investigation of photopheresis as new therapy regimen in patients with bronchiolitis obliterans syndrome after lung transplantation in a controlled, randomized study

bronchiolitis obliterans syndrome is the major cause of mortality after lung transplantation. 5 years after lung transplantation about 50% of all patients have this syndrome. there are nearly none therapy options. besides effective therapy of any gastrooesophageal reflux and an oral medication with azithromycin none further regimens are known. photopheresis could show in several studies a benefit for patients with gvhd after bone marrow transplantation or for chronic rejection after any other solid organ transplantation. just little case reports could show beneficial effect in patients with bos after lung transplantation. this is the first controlled, randomized study with patients with bos after lung transplantation to investigate the effectiveness of this therapy in that patients.

Eligibility criteria:
inclusion criteria: * single/double lung transplantation * at least 6 months after lung transplantation * bronchiolitis obliterans syndrome, stadium \> 1 (nach ishlt 2001, fev1 \<80% best), none other reason for worsening lung function (eg acute rejection, infection, extrapulmonary reasons, airway obstruction) * none gastroesophageal reflux * medication for \> 3 months with azithromycin with further decrease of fev1, mef 25-75 * bioptic prove that there is no acute rejection * no improvement under steroid pulse therapy exclusion criteria: * tumor or hematologic disease * acute rejection * respiratory insufficiency (o2\>2l/min, pco2 \>50 mm hg) * weight \< 40 kg * acute infection * colonization with multiresistant pathogens

Keywords: lung function fev1
susceptibility testing in neisseria gonorrhoeae (sting) study, assessing the performance of a new rapid test for gonorrhoea antibiotic resistance, in a cohort of 100 culture positive neisseria gonorrhoeae infections

Conditions: Diagnosis; Gonorrhea; Resistance Bacterial

Summary: this study aims to validate a novel antibiotic susceptibility test (insignia) for gonorrhoea in patient clinical samples. the hypothesis is that the insignia test will be able to detect transcriptional responses after incubation in antibiotic for susceptible strains and not resistant strains. furthermore, this study will also add to our understanding on the performance of this test in various clinical specimens.


Eligibility criteria:
inclusion criteria: * confirmed/suspected ng infection * willingness to give written informed consent as well as to participate in and comply with the study. exclusion criteria: * currently taking or having taken any antibiotics in the preceding 14 days * english fluency below level required to understand study procedures * unwilling or unable to comply with study procedures
laser-based photoacoustic tomography of human inflammatory arthritis

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this feasibility study is to determine if a new emerging technology called photoacoustic tomography (pat) can be adapted for use in humans for the detection of chronic rheumatoid arthritis.

the objective of this proposal is to adapt photoacoustic tomography (pat), a novel, nonionizing, noninvasive, laser-based technology, for structural and functional imaging of human peripheral joints affected by inflammatory arthritis. combining the advantages of both light and ultrasound scanning, pat holds promise to present objective optical information in subsurface joint tissues with high sensitivity and high spatial resolution. this could be of considerable help in the early detection of inflammatory joint diseases. pat may also prove useful in further understanding the pathophysiology of these disorders and assisting with therapeutic decisions, including assessment of new pharmacological therapies.

Eligibility criteria:
inclusion criteria: * men and women 18 years of age or older can participate in this study. * patients can participate in this study if they have had rheumatoid arthritis for more than 2 years and their rheumatologist has referred them to this study. * patients can participate as a healthy volunteer with a known history of rheumatoid arthritis. exclusion criteria: * patients, who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator. * pregnant patients. * patients who is claustrophobic. * patients with impaired renal function cannot participate in this study such as elevate creatinine clearance, patients on kidney dialysis etc. * patients with shock hypotension or unstable low blood pressure. * patients with rhabdomyolysis. * patients who have had a contrast enhanced (with gadolinium) mra (magnetic resonance angiography)/ or mri within the last 3 months. (contrast is a medication injected into a vein during a imaging examination that helps produce clearer images/pictures).

Keywords: rheumatoid arthritis
blood biomarkers from internal jugular vein for the diagnosis of alzheimer's disease

Conditions: Alzheimer Disease

Summary: the goal of this observational study is to explore the diagnostic performance of blood biomarkers from the internal jugular vein for the diagnosis of alzheimer's disease (ad) in patients with cognitive symptoms or concerns. the main question it aims to answer is: whether blood biomarkers from the internal jugular vein outperform those from the median cubital vein which is the routine site for venous blood collection?


Eligibility criteria:
inclusion criteria: 1. age: 40-90 years old (including 40 and 90 years); 2. patients with cognitive complaints or concerns; 3. willing and able to comply with all aspect of the protocol and provide written informed consent. if a subject lacks capacity to consent in the investigator's opinion, the subject's assent should be obtained, if required in accordance with local laws, regulations and customs, plus the written informed consent of a legal representative should be obtained (capacity to consent and definition of legal representative should be determined in accordance with applicable local laws and regulations). exclusion criteria: 1. severe medical conditions which are not stably and could affect the subject's safety; 2. presence of contraindications for pet examination, cerebrospinal fluid or blood collection; 3. unwilling and refuse to participate in this study.
a dose selection study of oral recombinant salmon calcitonin (rsct) in normal, healthy, postmenopausal women

Conditions: Osteoporosis

Summary: this study compares the performance of different doses of oral recombinant salmon calcitonin (rsct).


Eligibility criteria:
inclusion criteria: * postmenopausal female, in good health (at least 5 years since last menses) * age ≥45 and ≤70 * weight + or - 20% of the metropolitan life weight table * plasma c-terminal telopeptide of type i collagen (ctx-1) ≥ 0.25 ng/ml * total calcium (ca++), phosphorus (p), and magnesium (mg++) within normal range * willing and able to comply with all study requirements * willing and able to sign written informed consent * negative urine pregnancy test at screening * negative screen for hepatitis b and c, human immunodeficiency virus (hiv) and drugs of abuse exclusion criteria: * history of parathyroid, thyroid, pituitary or adrenal diseases * history of musculoskeletal disease * history of gastro-esophageal reflux disease (gerd) or other significant gastrointestinal disorders * history of cancer within 5 years of enrollment other than basal cell carcinoma * history of regular use of non-steroidal anti-inflammatory drugs (nsaid) * history of surgery within 60 days of enrollment * history of hypersensitivity or allergies (other than seasonal allergies) within 5 years of enrollment including known sensitivity to the active ingredients or the excipients in the study medications * use of concomitant medications other than acetaminophen within 7 days of enrollment or anticipated need to use such concomitant medications during the study * use of bisphosphonates within 6 months, selective selective estrogen receptor modulators (serms), estrogen or estrogen-like drugs 2 months, or calcitonin 1 month * presence of any clinically significant illness * unwilling or unable to comply with all study requirements * unwilling or unable to sign written, informed consent * history of drug or alcohol abuse * participation in any clinical study of an investigational drug within 60 days of enrollment * plasma ctx-1 less than 0.25 ng/ml
study of positive psychology and effects on well-being of anaesthesiologists in hong kong

Conditions: Burn Out; Stress, Psychological; Well-Being, Psychological; Self-Compassion; Depressive Symptoms; Anxiety Disorders and Symptoms

Summary: this clinical trial aims to evaluate whether positive psychology interventions via a hybrid approach will enhance well-being and resilience amongst anaesthesiologists in hong kong. the main questions it aims to answer are: * is app-based positive psychology intervention effective in improving well-being of physicians? * is app-based positive psychology intervention feasible amongst busy healthcare professionals? participants will be randomized to one of the two groups: * four-week web-based interventions * control group researchers will compare the intervention and control groups to see if the participants' benefit from the positive psychology intervention compared with not receiving it.


Eligibility criteria:
inclusion criteria: * fellows/members of the hong kong college of anaesthesiologists exclusion criteria: * no exclusion criteria is applied
evaluation of acclimate feature for positive airway pressure (pap) therapy

Conditions: Obstructive Sleep Apnea

Summary: the purpose of the study is to evaluate if using the acclimate feature at the beginning of positive airway pressure (pap) therapy results in patients using their pap therapy at least as long as they would standard therapy. additionally, the acclimate feature will be evaluated with regard to patient comfort, ease of acceptance of pap therapy, leak events, and respiratory events.

acclimate has been designed as a comfort feature for patients starting pap therapy. the feature allows acclimatization to the targeted positive airway pressure setting. using the acclimate feature, the pressure increases incrementally over a period of time. the feature can be only be used for a set period of time, afterwards which the device initiates the therapeutic session at the prescribed pressure.

Eligibility criteria:
inclusion criteria: * subjects ≥18 years of age. * recent diagnosis of moderate to severe osa where fixed pap is clinically indicated. * naïve to pap therapy. exclusion criteria: * patients requiring supplemental oxygen. * patients with a history of pneumothorax, pneumomediastinum, cavities or cysts in the lung. * previous surgery to the brain, middle or inner ear, pituitary gland or sinuses. * middle ear infection or perforated ear drum. * ongoing sinus infection/sinusitis. * clinically significant epistaxis. * predominant central sleep apneas in the subject's psg.

Keywords: osa sleep apnea pap positive airway pressure