Kornimate/medical-research-clean huggingface dataset:
an integrated intervention of computerized cognitive training and physical exercise in virtual reality for people with alzheimer's disease (jdome)

Conditions: Alzheimer Disease

Summary: jdome is a randomized controlled trial to test the effectiveness of a computerized cognitive training with the brainer web platform and aerobic training with the jdome system vs. a computerized cognitive training with the brainer web platform and aerobic training with a standard exercise bike in subjects with alzheimer's disease at early stage. the jdome bikearound is a tool that take people with dementia on a virtual bicycle tour along the paths of memories. it combines an exercise bike, a dome-shaped projector and google street view technology.

jdome study is designed as a randomized controlled trial to test the effectiveness of a training that combines the jdome virtual reality system for aerobic exercise with computerized cognitive training via tablet. the experimental group (eg) will receive computerized cognitive training with the brainer web platform and aerobic training with the jdome system (a tool that combines an exercise bike, a dome-shaped projector and google street view technology).the control group (cg) will receive computerized cognitive training with the brainer web platform and aerobic training with a standard exercise bike. assessment will be performed at the baseline (t0), at the end of intervention (after eight weeks -t1) and 12 weeks after the end of intervention (follow-up t2). the primary aim is to assess the stabilization of the global cognition of people with mild-stage alzheimer's disease at the mini-mental state examination (mmse) and at the alzheimer's disease assessment scale - cognitive subscale (adas-cog); the secondary aim is the analyses of the modification of the quality of life, mood, behavioral disturbances, and physical function in people with mild-stage alzheimer's disease.

Eligibility criteria:
inclusion criteria: * aged 65 and over; * pre-existing diagnosis of alzheimer's, in mild phase, according to the 2011 criteria of the national institute on aging-alzheimer's association (nia-aa); * clinical dementia rating scale cdr = 1; * mini mental state examination mmse \> 19; * functional ambulation categories fac ≥4; * tinetti scale ≥ 20; * presence of a contact family caregiver * reside at home exclusion criteria: * failure to meet the inclusion criteria * sensory deficits not compensated by the use of prostheses * psychological and behavioral disorders not compensated by drug treatment * medical contraindication to moderate intensity aerobic exercise

Keywords: alzheimer disease virtual system aerobic exercise cognitive training dementia quality of life
acoustic cluster therapy (act) with chemotherapy for the treatment of locally advanced pancreatic cancer

Conditions: Locally Advanced Pancreatic Adenocarcinoma

Summary: the purpose of the study is to assess the efficacy and safety of acoustic cluster therapy (act) when given in addition to chemotherapy for treatment of locally advanced pancreatic cancer.

patients with locally advanced pancreatic cancer who have not received prior treatment to their pancreatic cancer will receive act treatment (the drug ps101 and ultrasound application to the tumor) with up to eight 2-week cycles of modified folfirinox chemotherapy. act treatment will be given on day 1 of each cycle of chemotherapy. patients' well-being and side effects will be assessed at the same visits. the objective efficacy of the treatment will be assessed by ct scans every 8 weeks.

Eligibility criteria:
inclusion criteria: * not deemed suitable for primary curative surgery and have radiographic and pathological disease consistent with inoperable lapc or borderline resectable pancreatic cancer. * suitable to receive treatment with mfolfirinox according to the investigator's assessment. exclusion criteria: • any prior anti-cancer treatment for pancreatic cancer (e.g. chemotherapy, surgery, radiation). palliative bypass procedure and bile duct stenting are allowed.

Keywords: pancreatic cancer ps101 ultrasound microbubbles pancreatic ductal carcinoma locally advanced pancreatic cancer first line treatment chemotherapy acoustic cluster therapy mfolfirinox
effectiveness of rotarixtm vaccine in children aged between 12 weeks to < 5 years, hospitalised for severe gastroenteritis

Conditions: Infections, Rotavirus

Summary: this study aims to estimate the effectiveness of rotarix™ vaccine against rotavirus severe gastroenteritis (rv sge) among hospitalised children aged between 12 weeks and \< 5 years, in venezuela and to assess the current disease burden after introduction of the vaccine.

the data generated in this study will be useful for public health officers and policy makers in confirming the country-wide public health benefit of rotarix™. no vaccine will be administered during this study.

Eligibility criteria:
inclusion criteria: for sge subjects: * a male or female child aged 12 weeks to \< 5 years at the time of hospital admission/ ed stay. the subject becomes ineligible on the fifth birthday. * subject admitted to (or who will have an ed stay at) the study hospital(s) for sge during the study period. * onset of sge ≤ 14 days prior to admission/ ed stay. * written/thumb printed informed consent obtained from the parent(s)/legally acceptable representative(s) (lar (s)) of the subject. for cases: • laboratory confirmed (i.e. by elisa) rv-positive stool sample collected at hospital admission/ ed stay or during the first 48 hours of hospitalisation. for controls: * subject admitted to (or who will have an ed stay at) the same study hospital(s) for sge as that of the case during the study period. * laboratory confirmed (i.e. by elisa) rv-negative stool sample collected at hospital admission/ ed stay or during the first 48 hours of hospitalisation. * subjects born within ± 2 weeks from the date of birth of the case. exclusion criteria: for sge subjects: * child in care. * hospitalisation is unrelated to ge. * onset of sge \> 48 hours after admission to (or ed stay at) the hospital. * subject has digestive tube anomalies, chronic gastrointestinal disease or uncorrected congenital abnormalities. * subject with immunodeficiency. * subjects who live out of the federative entity where hospital(s) are located. for controls: • subject has previously participated as case in this study.

Keywords: rotarix™ case-control venezuela vaccine effectiveness rotavirus severe gastroenteritis children hospitalised
effect of lactoferrin in pneumonia treatment

Conditions: Pneumonia

Summary: pneumonia is defind as the inflammation of lung tissue caused by an infectious agent that results in acute respiratory signs and symptoms. community acquired pneumonia (cap) is a major cause of morbidity and increased health care costs. in developing nations, pneumonia remains a significant cause of mortality in children. pneumonia occurs in 30 to 45 of every 1,000 children under 5 years of age; it is less common in 5- to 9-year olds (16 to 22/1,000) and in older children (7 to 16/1,000). streptococcus pneumoniae is the primary bacterial cause of pneumonia in infants and children. viral etiologies become less prevalent and mycoplasmal and chlamydial infections become more prevalent with increasing age

lactoferrin (lf) is iron-binding glycoprotein of the transferrin family that is expressed and secreted by glandular cells and is found in most body fluids . it appears at especially high concentrations in mammalian milk and was first identified in bovine milk , and was subsequently isolated from human milk. lfs bacteriostatic function is due to its ability to take up the fe3+ ion, limiting use of this nutrient by bacteria at the infection site and inhibiting the growth of these microorganisms as well as the expression of their virulence factors .

Eligibility criteria:
inclusion criteria: * pneumonia patients * from the age of one month to the age of 18 years . exclusion criteria: neonates and any children with : * immune deficiency * congenital heart disease * neuromascular disorder * genetic syndromes
photodynamic therapy in treating patients with cancer of the bile duct, gallbladder, or pancreas

Conditions: Extrahepatic Bile Duct Cancer; Gallbladder Cancer; Liver Cancer; Pancreatic Cancer

Summary: rationale: photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. this may be effective treatment for cancer of the bile duct, gallbladder, or pancreas. purpose: phase ii trial to determine the effectiveness of photodynamic therapy in treating patients who have cancer of the bile duct, gallbladder, or pancreas.

objectives: i. determine the safety and efficacy of photodynamic therapy using porfimer sodium in patients with unresectable malignant bile duct obstruction. outline: patients are stratified according to tumor location (proximal vs distal). patients receive porfimer sodium iv over 3-5 minutes on day 1, followed by percutaneous or endoscopic laser light treatment on day 3. patients achieving partial response or complete response accompanied by an increase in total bilirubin or cholangitis may repeat treatment for a maximum of 3 courses. patients are followed weekly for 1 month, and then monthly for 1 year. projected accrual: approximately 30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically proven malignant bile duct obstruction with obstructive jaundice primary carcinoma of bile duct, gallbladder, or pancreas or metastatic bile duct disease successful insertion of a percutaneous drain or endoscopic stent unresectable disease or resectable disease but refusal of surgery prior biliary plastic or metallic stent allowed, if requiring stent replacement due to recurrent jaundice or routine plastic stent change no erosion of biliary tumors into major blood vessels no evidence of bile duct perforation patient characteristics: age: 18 and over performance status: karnofsky 50-100% life expectancy: not specified hematopoietic: not specified hepatic: bilirubin at least 2 mg/dl renal: not specified other: no history of allergies or hypersensitivity to porphyrins no porphyria no cholangitis or pancreatitis prior concurrent therapy: biologic therapy: not specified chemotherapy: at least 4 weeks since prior chemotherapy endocrine therapy: not specified radiotherapy: no concurrent radiotherapy or brachytherapy to the abdomen surgery: see disease characteristics other: no other prior or concurrent experimental or investigational drugs

Keywords: stage i pancreatic cancer stage ii pancreatic cancer stage iii pancreatic cancer stage iv pancreatic cancer recurrent pancreatic cancer unresectable gallbladder cancer recurrent gallbladder cancer unresectable extrahepatic bile duct cancer recurrent extrahepatic bile duct cancer cholangiocarcinoma of the gallbladder cholangiocarcinoma of the extrahepatic bile duct adult primary cholangiocellular carcinoma
panel study investigating status of cognitively impaired elderly in singapore

Conditions: Advanced Dementia

Summary: dementia affects 10% of the elderly population in singapore. however, there is a lack of systematic information regarding end of life (eol) care received by patients dying with severe dementia (pdsd), pdsd's eol direct and indirect costs and caregiver burden. this study, a first of-its-kind prospective cohort study in singapore will assess the eol care received by pdsd and pdsd's caregivers, eol medical and social care costs of severe dementia and caregiver burden; and will develop a risk score to predict 6-month mortality for pdsd. the investigators will accomplish this by surveying caregivers of pdsd every 4 months till the patient passes away and 6 weeks and 6 months after patient's death during caregiver bereavement. the investigators will also extract and match patient medical and billing data with survey data for comprehensive assessment of care costs. key outcomes achieved by this study will be improved understanding of pdsd's eol care, eol care costs, and caregiver burden and bereavement. the systematic data collected will also lead to predicting 6 month mortality for community dwelling pdsd with greater accuracy compared to existing tools. positive implications from this study will be improved early decision making by caregivers regarding eol care and physician referrals for palliative care services; and a better understanding of eol care for pdsd and pdsd's caregivers that will lead to cross-sector collaborations to improve delivery of palliative care to pdsd. in this way this proposal is highly responsive to the grant call which focuses on early decision making and cross sector palliative care delivery among non-cancer patients. in the long term, this study will improve clinical and public health policy and has the potential to be the foundation for future initiatives for dementia care and improved social and medical infrastructure planning.


Eligibility criteria:
inclusion criteria for primary informal caregivers are: 1. age ≥ 21 years old 2. singaporean/singapore permanent resident 3. intact cognition determined through the abbreviated mental test (amt) for those who are ≥ 65 years old 4. patients who score 20 or more on qdrs answered by caregivers will be considered to have severe dementia 5. main person or one of the main persons providing care to patient (e.g. accompanying patient for doctor's visits, helping patient with day to day activities) 6. main person or one of the main persons ensuring the provision of care to patient (e.g. supervision of foreign domestic worker so that patient is looked after) 7. main person or one of the main persons involved in making decisions regarding treatment patient receives exclusion criteria for primary informal caregivers are: 1. caregivers ≥ 65 years old with cognitive impairment or serious mental illness determined through amt 2. foreign domestic workers/maids inclusion criteria for physicians are: (a) caregivers of patients they are treating are enrolled in the study
study of colon gvax and cyclophosphamide in patients with metastatic colorectal cancer

Conditions: Colorectal Cancer; Metastatic Cancer

Summary: the primary objective of this study is to evaluate the safety and feasibility of vaccination with two irradiated allogeneic colorectal carcinoma cells administered with a gm-csf producing bystander cell line in sequence with an immunomodulatory dose of cyclophosphamide


Eligibility criteria:
inclusion criteria: * documented metastatic colorectal cancer * ecog performance status of 0 to 1 * adequate organ function as defined by study-specified laboratory tests * must use acceptable form of birth control through the study and for 28 days after final dose of study drug * signed informed consent form * life expectance \> 12 weeks exclusion criteria: * currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune, or other medical conditions * systemically active steroid use * another investigational product within 28 days prior to receiving study drug * major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug * chemotherapy, radiation, or biological cancer therapy within 28 days prior to receiving study drug * no known history or evidence of cns metastases \< 2 years. * pregnant or lactating * unwilling or unable to comply with study procedures

Keywords: adenocarcinoma of the colon adenocarcinoma of the rectum stage iv colon cancer stage iv rectal cancer
critical view of safety in laparoscopic cholecystectomy

Conditions: Chronic Calculous Cholecystitis

Summary: this prospective cohort study aims to assess feasibility and safety of the approach of critical view of safety during laparoscopic cholecystectomy

since the introduction and routine use of laparoscopic cholecystectomy in the 1990s, the reported incidence of biliary injuries has doubled to 0.4%. many factors have been shown to influence the risk of biliary injury including patient factors (obesity, older age, male gender and adhesions), local factors (severe gallbladder inflammation/infection, aberrant anatomy and haemorrhage) as well as surgeon experience. identifying the common bile duct as the cystic duct is the commonest cause of major bile duct injury active identification of cystic structures within calot's triangle is the key to a reduction in biliary injury. strasberg first coined the term 'critical view of safety' (cvs) in 1958 and this approach of identification of cystic structures has been adopted by many surgeons as the standard of operative technique to reduce the incidence of biliary injury. to fulfil the criteria for a cvs requires calot's triangle to be cleared free of fat and fibrous tissue ('fat cleared'), for the lowest part of the gallbladder to be dissected free from the cystic plate ('liver visible') and for there to be only two structures entering the gallbladder ('2 structures'). the published rate of bile duct injury with this approach is very low however more studies are needed to assess risk benefit rate of this approach.

Eligibility criteria:
inclusion criteria: * include all patients who will have laparoscopic cholecystectomy exclusion criteria :- * emergency laparoscopic cholecystectomy * liver cirrhosis * hcv \& hbv
identifying atopic dermatitis patients at risk for developing conjunctivitis during dupilumab treatment

Conditions: Atopic Dermatitis

Summary: study on ophthalmological comorbidities and the underlying pathomechanisms of conjunctivitis during dupilumab treatment in atopic dermatitis (ad) patients. patients participate in the bioday registry.


Eligibility criteria:
inclusion criteria: * adult patients with atopic dermatitis indicated for dupilumab, without current use of oral immunosuppressive treatment . exclusion criteria: * treatment with oral or ocular immunosuppressive drugs 2 weeks prior to start of dupilumab treatment

Keywords: dupilumab dupixent conjunctivitis bioday
a double-blind, randomized, comparative study of delavirdine mesylate (u-90152s) in combination with didanosine (ddi) versus ddi alone in hiv-1 infected individuals with cd4 counts of <= 300/mm3

Conditions: HIV Infections

Summary: to evaluate the safety, tolerance, pharmacokinetics, and efficacy of delavirdine mesylate (u-90152s) in combination with didanosine (ddi) versus ddi alone in hiv-positive patients.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * azt. patients must have: * hiv-1 seropositivity. * cd4 count \<= 300 cells/mm3. * no active or acute (onset within the past month) opportunistic infections such as active cryptococcosis, pneumocystis carinii, herpes zoster, histoplasmosis, or cytomegalovirus (cmv). * consent of parent or guardian if less than 18 years of age. * understanding of potential risk to fetus related to study participation. * acceptable medical history, physical exam, ekg, and chest x-ray during screening. note: * patients with cutaneous kaposi's sarcoma requiring no systemic therapy are permitted. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * active tuberculosis that is sensitive to rifampin. * inability to swallow numerous tablets. * clinically significant active or acute medical problems, including progressive multifocal leukoencephalopathy, lymphoma, or malignancy requiring systemic therapy. * clinically significant hypersensitivity to piperazine-type drugs (e.g., antepar and stelazine). * grade 2 or worse baseline organ function. note: * hemophiliacs with grade 2 bilirubin, alkaline phosphatase, sgot, or sgpt will be considered if these values have been stable over the past year. note: * patients with suspected gilbert's syndrome will be considered if bilirubin is grade 2 or better. patients with the following prior conditions are excluded: * history of pancreatitis within the past 2 years. * history of clinically significant nervous system or muscle disease, seizure disorder, aids dementia, or psychiatric disorder that would preclude study compliance. * history of grade 2 or worse peripheral neuropathy. * intolerance to ddi in previous treated patients. prior medication: excluded: * more than 4 months total of prior ddi. * any prior ddc, d4t, or 3tc. * prior nonnucleoside reverse transcriptase inhibitors, including l-drugs, nevirapine, tibo, hept, delavirdine, atevirdine, and alpha-apa. * other investigational antiretroviral medications (including foscarnet) or immunomodulators (including all interferons) within 21 days prior to initial study drug dose. * prior prophylactic or therapeutic hiv-1 gp120 or 160 vaccines. * rifampin, rifabutin, astemizole, loratadine, or terfenadine within 21 days prior to initial study drug dose. * any unapproved investigational medication for any indication within 21 days prior to initial study drug dose. required: * azt therapy at some time prior to screening. active substance abuse.

Keywords: didanosine drug therapy, combination acquired immunodeficiency syndrome aids-related complex antiviral agents
acupressure to treat nausea and vomiting in hiv/aids patients

Conditions: HIV Infections

Summary: the purpose of this study is to see whether acupressure (acupuncture using pressure applied by the hands instead of needles) can help nausea and vomiting in persons with hiv/aids.

this is a phase i trial (a study to evaluate effectiveness in a small number of patients). patients will get 4 acupressure treatments and will wear acupressure wristbands for 1 week. patients will write down all drugs they take and will make a note of when they get nausea and vomiting. they also will give written answers to different questions. no drugs will be given as part of this study. patients will be paid for participating.

Eligibility criteria:
inclusion criteria: * are hiv-positive. * have nausea and/or vomiting an average of 2 times per day for at least 1 week.

Keywords: complementary therapies acupressure hiv infections nausea vomiting