Kornimate/medical-research-clean huggingface dataset:
cardiovascular prehabilitation in patients awaiting heart transplantation (prehab htx study)

Conditions: Heart Failure

Summary: this study evaluates the addition of high-intensity interval training to the standard pre-heart transplantation clinical care. participants will be randomised into 2 arms: one arm will receive high-intensity interval training, and the other arm will be encouraged to remain physically active, although they do not participate in a regular structured exercise training program.

heart failure affects more than 6.2 million people living in north america. approximately 10% of patients with heart failure have advanced heart failure. heart transplantation is an effective life-saving treatment for patients with advanced heart failure. the cardiovascular rehabilitation programs are integral to heart failure management. this study is being done to evaluate, in adults with advanced heart failure awaiting heart transplantation, the effects of cardiovascular rehabilitation (including high-intensity interval training, stress management and nutrition workshops) on functional capacity, aerobic power, frailty, quality of life, and mental health. this study compares pre-transplant cardiovascular rehabilitation with usual pre-transplant care in patients with advanced heart failure awaiting heart transplant. all participants will be randomized into 2 study groups: group 1 (rehab), and group 2 (no rehab). those randomized to group 1 will receive usual care, 12 weeks of rehab (exercise training, and attend stress and nutrition course through the heart failure clinic and the division of prevention and rehabilitation at the university of ottawa heart institute). those randomized to group 2 will receive regular visits through the heart failure clinic; patients are encouraged to remain physically active, although they do not participate in a regular structured exercise training program.

Eligibility criteria:
inclusion criteria: 1. advanced heart failure and listed for heart transplantation. 2. able to perform a symptom-limited exercise test. 3. age =\>18 years old. 4. able to provide informed consent. exclusion criteria: 1. currently participating in a structured exercise training program (\> 2 times per week) 2. status 4 priority listing for heart transplantation. 3. myocardial infarction =\<7 days. 4. heart failure with hemodynamic instability. 5. hypertrophic obstructive cardiomyopathy with symptomatic left ventricular outflow tract gradient =\>30 mmhg.

Keywords: heart failure
fetal heart ultrasound suspicious radiographic finding identification - reader study

Conditions: Congenital Heart Disease

Summary: clinical performance of the device will be evaluated in a fully-crossed, multiple-reader multiple-case (mrmc) study. this study will be used to determine the impact of the device on reader performance in identifying suspicious radiographic findings in fetal heart ultrasound video clips recorded during 2nd trimester anatomic ultrasound examinations conducted during the second trimester of the pregnancy.


Eligibility criteria:
inclusion criteria: * ultrasound examinations conducted during the second trimester of the pregnancy * fetus between 18 and 24 weeks of gestational age * mothers 18 years old or older exclusion criteria: * exams corresponding to multiple pregnancy * fetal heterotaxy * exams not containing video clips with interpretable 4-chamber (4c), left ventricular outflow tract (lvot) or right ventricular outflow tract (rvot) standard views
effect of teriparatide, vibration and the combination on bone mass and bone architecture in chronic spinal cord injury

Conditions: Spinal Cord Injury; Bone Loss; Osteoporosis

Summary: spinal cord injury (sci) results in marked acute loss of bone. this study evaluates the effect of teriparatide (pth) and the use of vibration as a form of mechanical stimulation on bone mass.

the aim of this study is to evaluate pth with vibration in a group of individuals with chronic sci and loss of bone mass in their lower extremities. a convenience sample of 60 subjects with sci will be enrolled into a 12 month study assessing the effects of pth (20 ug/day) and vibration (10 min/day) individually or in combination on bmd and bone markers. subjects will be evaluated at 3, 6, 9, and 12 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption.

Eligibility criteria:
inclusion criteria: age \>21 years (must have closed epiphyses; pth contraindicated if epiphyses open) * both males and females * sci with inability to ambulate independently * capable of positioning to have dxa performed * low bone mass at the total hip by dexa (z score \< 1.5; t score \< 2.5 or t score \<-2.0 plus preexisting fragility fracture) * capable of reading and understanding informed consent document * able to self-administer teriparatide or have someone in the family who can do so * no known endocrinopathies * normal tsh levels * normal 25-oh vitamin d levels (\> 30ng/ml) * normal calcium levels * normal renal function (creatinine \<2.0mg/dl) * able to return for all follow-up visits exclusion criteria: surgical or other intervention resulting in metal or anatomy precluding obtaining dxa measurements (e.g., cardiac pacemakers, ferromagnetic implants or brain aneurysm clips). * had had an allergic reaction to teriparatide (forteo) or one of its ingredients. * have paget's disease of the bone * have unexplained high levels of f alkaline phosphatase in blood * any active gastrointestinal condition that results in malabsorption * history of presence of alcoholism or drug abuse within the 2 years prior to study screening * other medical conditions that in the opinion of the investigator would preclude the subject from completing the study * history of malignancy. patients having had basal cell carcinomas successfully removed will be allowed to enroll in the protocol. * history of radiation therapy * unable to self-administer pth or have it administered * elevated liver function tests \>2x normal * currently being prescribed anti-convulsants * currently being prescribed glucocorticoids, other than inhaled glucocorticoids * currently being prescribed any bone-active agents, including any bisphosphonate, raloxifene, hormone therapy (estrogen and estrogen/progestin), calcitonin or strontium-containing compounds. bisphosphonate use will be allowed up the time of initiation of study medication but not during the dosing with study medication. * previous history of pth use * pregnant, planning to become pregnant, or lactating
vaxzevria japan post-marketing surveillance (pms) for the subjects with underlying disease at high-risk for worsening covid-19

Conditions: Prevention of Infectious Disease Caused by SARS-CoV-2

Summary: to provide more information on safety profile of vaxzevria in japanese subjects, specific drug use result study in subjects with underling disease at higher risk of worsening covid-19 is planned as an additional pharmacovigilance plan. the present study aims to collect information on adverse drug reactions or covid-19 infection after vaxzevria vaccination and to evaluate the safety of this vaccine.

to provide more information on safety profile of vaxzevria in japanese subjects, specific drug use result study in subjects with underling disease at higher risk of worsening covid-19 is planned as an additional pharmacovigilance plan. the present study aims to collect information on adverse drug reactions (local/systemic reactions), adverse events (including shock/ anaphylaxis, thrombosis in combination with thrombocytopenia, immune-mediated neurological conditions ,vaccine-associated enhanced disease(vaed) including vaccine-associated enhanced respiratory disease(vaerd) and thrombosis) or covid-19 infection after vaxzevria vaccination and to evaluate the safety of this vaccine

Eligibility criteria:
inclusion criteria: 1. the subjects with underlying disease at high-risk for worsening covid-19. 2. the adults (in the case of a minor aged less than 20 years, the parent or the legal guardian) who are able to enter their symptoms in the health observation diary and who have been fully informed and have given written consent to the use of the needed information to be part of the observational study. exclusion criteria: none
a genetic study for alzheimer dementia: case-control study

Conditions: Alzheimer Dementia (AD)

Summary: the purpose of this study is to find out the difference in genetic test results between alzheimer's dementia patients and healthy subjects. the investigators want to identify genes that are importantly related to alzheimer's dementia.


Eligibility criteria:
1. inclusion criteria: alzheimer's dementia patient * adult patients over 60 years old * patients with a alzheimer's dementia patient * total korean version of mini-mental state examination (k-mmse) score less than 24 * total clinical dementia rating (cdr) over 0.5 2. inclusion criteria: healthy subjects * adult healthy over 60 years old * total korean version of mini-mental state examination (k-mmse) over 24 * total clinical dementia rating (cdr) is 0 3. exclusion criteria: * those with severe medical conditions such as unstable conditions of the cardiovascular system, digestive system, respiratory system, endocrine system, etc., who are in poor general condition * in the case of a person with impaired consent (mmse less than 10 points), if not accompanied by a guardian * other cases where the researcher determines that participation in this clinical trial is not appropriate (patients who are participating in other studies or have participated in other studies within the past 30 days can also participate in this study.)
the effect of nuchal ligament calcification on cervical function in patients with neck pain

Conditions: Neck Pain

Summary: ossification of nuchal ligament often observed in patient with chronic neck pain, previous study showed ossification of nuchal ligament was associated with cervical spondylosis and radiculopathy. patient with chronic neck pain was divided into two groups according to the presence of ossification of nuchal ligament on cervical radiographic images. this study is to evaluate and compare the neck function including range of motion, neck strength and pressure pain threshold, radiography characteristics and functional disability between two groups.


Eligibility criteria:
inclusion criteria: * patient with neck pain and stiffness last for more than 1 month exclusion criteria: * cervical trauma or fracture in 3 months * evidence of cervical spine instability * rheumatoid cervical spondylopathy * previous cervical surgery * head and neck cancer * previous radiotherapy over neck and surrounding * those complicated with myelopathy * contraindication to radiography like pregnant woman

Keywords: ossification of nuchal ligament
impact of braun anastomosis on reduction in delayed gastric emptying following pancreaticoduodenectomy

Conditions: Periampullary Pathology Requiring Pancreaticoduodenectomy

Summary: pylorus preserving pancreaticoduodenectomy (pppd) has been considered as only curative treatment modality for periampullary tumor. high mortality rates after pppd have been reduced down to 1%. however, postoperative morbidities are still reported around 10 to 20 % even in high volume centers.the delayed gastric emptying syndrome(dge) is one of major complications after pppd. many randomized control studies reported that pylorus preserving method was not related to the occurence of dge. thus,we assumed that large amount of biliary and pancreatic juice might affect dge. with the aim to prove that the use of braun anastomosis after pppd can prevent dge, the investigators started the recruitment of patients with a periampullary tumors to this clinical trial from february 2013 with the study hypothesis that patients with braun anastomosis had less dge than those who only got conventional pppd. the investigators have calculated the number of patients necessaries to have statistical significant differences in 60 patients with a rate dge expected to be higher than 30%. the study include all the patients that usually arrive to our surgery department and who are indicated to pppd for the curative treatment of periampullary tumor. the study is randomized, double blind where the investigators and the patients do not know if the patients are in the braun anastomosis group or not, and prospectively analyzed. all the clinical and laboratory or radiographic finds relative to the occurrence of dge are recorded.


Eligibility criteria:
inclusion criteria: 1. patients with periampullary disease who have to be treated by pppd * pancreatic cancer, distal bile duct cancer, duodenal cancer, and so on. 2. 20 year to 80 year-old patients 3. in terms of general performance status, the patients with more than 70% of the karnofsky score or ecog 0 to 1. exclusion criteria: 1. patients with unresectable or locally advanced and metastatic cancer. 2. the patient who does not want to take the operation. 3. the patient with more than 3 of asa score. 4. drug abusers or alcoholics. 5. non-compliances 6. the patient who does not want to participate the clinical trials. 7. the patients who can not read or understand about informed consent form such as a mentally retarded person, the blind, illiteracy, or foreigner. 8. the patient who have previous transabdominal surgery 9. the patient who have to have resection of other organs or vessels other than standard pppd 10. the patient who is indicated to laparoscopic pppd

Keywords: pylorus preserving pancreaticoduodenectomy(pppd), delayed gastric emptying syndrome(dge), braun anastomosis
tobacco cessation among smokers under alcohol and/or cannabis treatment

Conditions: Mental Health Disorder; Substance Abuse Drug; Alcohol Abuse; Cannabis Use; Tobacco Use; Smoking Cessation

Summary: aims: to identify the predictors associated with smoking cessation in smokers under treatment for alcohol and/or cannabis treated in drug treatment centers (dtc). methodology: mixed methods project with qualitative and quantitative designs (three studies). study i discussion groups: of clinical professionals of dtc to explore the barriers/facilitators of these smokers in quitting and the interventions carried out. study ii prospective cohort of smokers in alcohol and/or cannabis treatment that will be followed-up for 12 months. sample size: difference in incidence (exposed to cessation interventions versus non-exposed = 12 per 100 years), α = 0.05, β = 0.10, losses = 20% (n = 726). dependent variables: self-reported and verified tobacco consumption abstinence, quit attempts, motivation, and self-efficacy. independent variables: age, sex, the substance under treatment. analysis: incidence, relative risk and simple and multiple logistic regression models (odds ratio and confidence interval, ci, 95%) of quitting. study iii discussion groups: with smokers under alcohol and/or cannabis treatment selected according to their typology. analysis: of thematic content and triangulation qualitative and quantitative results. expected results: characterization of variables that influence tobacco cessation, to improve the design of interventions.


Eligibility criteria:
inclusion criteria: * smokers (at least 1cig./week) * undertreatment for cannabis and/or alcohol abuse for the first time * \>=18 years-old * under clinical follow-up * informed consent exclusion criteria: * severe cognitive impairment * 12-month follow-up not guaranteed
5-fluorouracil following cervical intraepithelial neoplasia treatment among hiv-positive women in east africa

Conditions: CIN 2/3; HIV Infections

Summary: this is a single arm study on the safety, feasibility, and acceptability of adjuvant, self-administered, intravaginal 5-fluorouracil (5-fu) following treatment for high-grade cervical precancer (cin2/3) among women living with human immunodeficiency virus (hiv).


Eligibility criteria:
subjects must meet all of the inclusion criteria to participate in this study. inclusion criteria: 1. hiv-positive women 2. age 18 years - 49 years at enrollment 3. documentation of a biopsy-confirmed cin2 or cin3 4. within 4-12 weeks after primary treatment for cin2 or cin3 5. negative pregnancy test at screening and agreement to use dual form of contraception (hormonal birth control, intrauterine device, or tubal ligation - plus condoms) during the study duration, if of childbearing age. 6. agree to use dual contraception if of childbearing age (hormonal method, intrauterine or implant device, or tubal ligation - plus condoms) for duration of study 7. ability to understand and willingness to sign (or assent when applicable) informed consent exclusion criteria: 1. hiv-negative women 2. pregnant or planning pregnancy within the next 6 months or breastfeeding 3. unwilling or unable to use birth control during participation in the study 4. history of invasive cervical cancer 5. untreated vaginal or vulvar dysplasia 6. known allergy to 5-fluorouracil 7. history of total hysterectomy 8. presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient 9. current use of chemotherapeutic medication or high dose steroids (10 mg prednisone per day or more (or equivalent steroids)

Keywords: cervical cancer cin 2/3 5-fluorouracil
magnetic resonance elastography in patients with abdominal aortic aneurysms

Conditions: Abdominal Aortic Aneurysm

Summary: the main objective of this study is to utilize magnetic resonance elastography (mre) to determine tissue stiffness of abdominal aortic aneurysms (aaa). for patients with aaa, mre is a more sensitive and superior method of determining the risk for rupture of aaa based on stiffness estimates when compared to the current, crude method of assessing risk based on measurement of the diameter of the aneurysm. the investigators will also validate the stiffness estimates against gold standard i.e. mechanical testing and histopathology only aaa patients undergoing aaa surgery.

currently, mre is a clinical tool used to assess hepatic fibrosis at many institutions. mre is superior to invasive techniques (i.e. biopsies) and mechanical testing in that it is noninvasive and can be performed in vivo under physiologic conditions. mre could make diagnosing stiffness widely available and could revolutionize the diagnosis and treatment of numerous other diseases affecting stiffness of soft tissues. aortic wall "stiffness" is a fundamental biomechanical parameter that reflects the structural integrity of normal and aneurysmal aortic tissue. aaas enlarge over time leading to sudden rupture and death in up to 90% of patients. surgical or endovascular aneurysm repair (evar) is recommended for aaas \> 5.5 cm in diameter. however, previous studies have reported a high percentage (13%) of smaller aaas (\ 5 cm) remain stable. despite the poor prognostic value of aortic diameter, it is still the primary parameter used to time surgical repair. it is known that changes in stiffness of aaa can reveal important information on extra-cellular matrix content; a key factor in the pathophysiological development of aaa and the risk for rupture. a non-invasive, spatially resolved estimate of aortic stiffness may provide a superior determinant of the risk for rupture compared to the currently used anatomical measures. the relationship between non-invasively measured wall stiffness (ws) and the structural integrity of the aortic wall must be further elucidated. therefore, aortic mre can be used as a noninvasive tool to estimate the stiffness of aaas and can provide superior diagnostic and prognostic information in patients with developing aaa disease. entry to this study is open to men and women aged 18 years and older, and to all racial and ethnic subgroups. two separate groups of patients with aaa will be recruited. one group will be patients who have been diagnosed with aaa and are monitored to observe the size of the aaa. the other group is comprised of patients who are scheduled for surgical repair of aaa.

Eligibility criteria:
inclusion criteria: * must be able to lie flat on their back in the scanner for up to 60 minutes * must be able to hold breath for up to 15 seconds exclusion criteria: * patients who are claustrophobic * patients who are pregnant * patients with any unapproved, non-mri save metal/devices in or on their body
comparison of high-dose chemotherapy + rituximab and chop + rituximab in high-risk follicular lymphoma

Conditions: Follicular Lymphoma

Summary: the purpose of this study is to determine whether an intensified treatment plus rituximab followed by autologous transplantation is superior to a conventional chemotherapy regimen also supplemented with rituximab.

the place of intensified regimens with autologous stem cell transplantation (asct) is poorly defined in fl at diagnosis . most data arise from studies performed in the pre-rituximab age. according to these studies, asct improved overall survival versus standard salvage approaches in relapsed patients with a high proportion of patients achieving a durable molecular remission. data at diagnosis are less clear. three studies have been so far published with contradictory results. two of these studies showed that intensive therapy ensures a better disease control although in one study a significant extra-mortality from secondary tumors was observed in the intensified arm. a third study found no advantage for patients treated intensively. these results led to the widespread notion that asct is not superior to conventional chemotherapy in unselected fl patients. our previous non-randomized experience employing high dose sequential chemotherapy with a final tbi-free asct added some clues to these considerations. our study employs an autografting procedure which is associated to fewer secondary tumors as it does not include total body irradiation. moreover we have observed that the our regimen (named hds) is particularly effective in high-risk patients, suggesting that this specific subgroup is the most appropriate setting for intensified regimens the present multicenter open label randomized trial took advantage of these observations. in addition we have included rituximab in both arms as the inclusion of this novel agent is expected to significantly modify the performance of available treatments. we have thus compared a rituximab-supplemented version of hds (r-hds) regimen with six chop courses supplemented by an identical number of rituximab courses. aim of the study was verify if an intensified approach could be beneficial as first line treatment of high-risk fl patients in the rituximab age.

Eligibility criteria:
inclusion criteria: 1. follicular lymphoma at diagnosis 2. stage \>i 3. age-adjusted i.p.i. score 2 or 3 or three or more adverse factors of the i.l.i. score exclusion criteria: 1. serum positivity for hiv, hcv. hbsag-positive only if active viral replication, assessed by hbv-dna was present. 2. major alterations of heart, lung, kidneys, liver, except for those directly disease-related; 3. evidence of second tumors; 4. previous chemotherapy( except patients who received limited radiotherapy); 5. cerebral or cns involvement. 6. drug addiction or severe psychiatric disease

Keywords: follicular lymphoma age adjusted ipi >1 iil score > 2 molecular remission high dose chemotherapy and autologous transplantation rituximab