Kornimate/medical-research-clean huggingface dataset:
activonline: physical activity in cystic fibrosis trial uk

Conditions: Cystic Fibrosis

Summary: increased level of physical activity (pa) are of benefit in the management of cystic fibrosis (cf). this randomised control tial will assess whether three-months use of an online platform can help increase pa levels in people with cf (compared to a control group continuing routine treatment).

cystic fibrosis (cf) is a genetic condition that predominantly affects the lungs through an accumulation of thick mucus. as there is no cure for cf, it is a disease that is managed through intensive medication, nutrition, physiotherapy, exercise and physical activity (pa). increased levels of pa are of benefit to people with cf, and therefore interventions that promote pa are warranted, particularly in adolescence, whereby pa levels decrease. telehealth interventions are of particular interest in cf, whereby strict cross-infection guidelines prevent patients meeting in person, and allowing patients to overcome geographical barriers at the same time. previous research has shown engagement with an online platform (www.activonline.com.au), specifically designed to monitor pa in cf, is feasible and acceptable to people with cf. therefore, a full randomised control trial is warranted to assess the efficacy of this intervention in changing pa. update june 2021: due to ongoing restrictions placed upon research by the global covid-19 pandemic, modifications to the protocol are necessary. recruitment and consenting will now take place online, and testing procedures will be completed by participants in their own homes. the nature, and length of, intervention remains unchanged. changes to protocol approved by ethics board on may 4th 2021.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cf * aged 12-35 years (inclusive) * able to provide informed consent/assent * able to access the internet via computer or mobile device exclusion criteria: * presence of severe co-morbidity limiting mobilisation or physical activity participation (e.g. orthopaedic, cardiac or neurological condition) * previous lung transplantation * pregnancy * unable to provide informed consent/assent
laparascopic assisted colonoscopic polypectomy

Conditions: Colon Polyps

Summary: study objective: to compare the hospital costs between the standard surgical procedure and the laparascopic assisted colonoscopic polypectomy (lacp) technique for patients with advanced polyps in the colon.

all patients being referred for possible lacp to the division of colorectal surgery at stony brook university medical center will be randomized in a 1:1 fashion using a computer generated system to undergo either partial colectomy (performed by means of laparoscopy when possible), or lacp for the treatment of advanced polyp(s). our research assistant will be present in the operating room to record the data.patients will then undergo standard clinical management while hospitalized at stony brook according to the procedure performed.

Eligibility criteria:
inclusion criteria: * polyp spanning 2 or more colonic folds * polyp \> 20mm * polyp spanning greater than 50% of the colonic circumference * positive "lift sign" following submucosal injection of saline beneath the polyp * difficult location or position of the polyp, thus preventing assurance of complete endoscopic resection. exclusion criteria: * polyps with histological evidence of adenocarcinoma * polyps in the rectum (\<15cm from anal verge) * patients with known inflammatory bowel disease (ibd). * patients with known familiar adenomatous polyposis (fap) syndrome * polyps without known histology (i.e. not previously biopsied) * polyps with large ulcerations, or those that demonstrate a "non-lift sign" during submucosal injection at the time of colonoscopy; as these are indicators of adenocarcinoma . * severe cardio-pulmonary disease, or irreversible coagulopathy, preventing abdominal surgery at an acceptable risk. * possum predicted mortality score greater than 2% * inability to obtain informed consent * patients under the age of 18 * pregnant patients

Keywords: polypectomy laparoscopic
pilot study on once daily ftc, ddi, efavirenz combination in antiretroviral naive hiv infected adults

Conditions: HIV Infections; Antiretroviral Naive

Summary: in 1999, when initiating antiretroviral treatment in hiv infected adults, a triple combination with protease inhibitor is recommended. such therapy induces side effects and the number of pills may reduce therapy adherence. the aim of this study is to evaluate the efficacy and the safety of a once daily ftc, ddi, efavirenz combination, in hiv patients with cd4 cell count over 100/mm3, antiretroviral naive.

in 1999, when initiating antiretroviral treatment in hiv infected adults, a triple combination with protease inhibitor is recommended. side effects of this products and the number of pills may induce a lower adherence, and thus a lower efficacy. 40 patients with a cd4 count over 100/mm3, a hiv rna over 5,000 copies/ml and antiretroviral naive, take the once daily combination of ftc, ddi, efavirenz during 24 weeks. the primary end-point is the viral success maintained from 12 weeks until 24 weeks. secondary end-point is the adherence to the association and safety. the trial is prolonged during a total of 72 weeks.

Eligibility criteria:
inclusion criteria: * hiv infection * antiretroviral naive * cd4 cell count over 100/mm3 * plasma hiv rna load over 5,000 copies/ml * signed written informed consent exclusion criteria: * hepatitis b infection * pregnancy * alcool abuse * acute infection, past neurological or pancreatic disease, biological abnormalities * chemotherapy or immunotherapy

Keywords: hiv infections reverse transcriptase inhibitors
single-institution register of individuals undergoing cancer genetic risk assessment

Conditions: Genetic Predisposition to Cancer

Summary: single-centre, retrospective, prospective observational cohort study, based on the registration of data from users of the oncology genetics outpatient clinic

the primary objective of this study is to establish a register to collect and update over time the clinical, genetic and socio-demographic data of all patients who will be assessed for a suspected oncological genetic predisposition, in order to acquire information that can be used for conducting specific studies aimed at clarifying the various uncertainties that still characterise these diseases, such as the clinical significance and the genotype-phenotype correlations of many alterations in oncological predisposition genes oncological predisposition genes, the clinical and bio-pathological features predictive of a significant probability of identifying mutations in these genes, the efficacy of surveillance and prevention measures undertaken to reduce the risk oncological risk according to guidelines, the effectiveness of oncological therapies in patients with hereditary tumours in comparison with those with sporadic neoplasms sporadic neoplasms, risk perception, emotional impact and also interpersonal experiences associated with oncological genetic risk assessment. these are objectives of primary interest to both the patient and public health (given the general frequency of oncological diseases), because the information acquired will make it possible to improve the general clinical management of all cancer patients and their families.

Eligibility criteria:
inclusion criteria: * participants aged 0 days or older at the time of genetic counselling * obtaining a signed informed consent exclusion criteria: * misdiagnosis of oncological counselling during oncological genetic counselling
correlation of albuminuria with arterial stiffness

Conditions: Diabetes Mellitus; Hypertension; Albuminuria; Vascular Stiffness

Summary: the investigators aim to investigate the relationship between albuminuria and arterial stiffness in diabetic patients, hypertensive patients and healthy subjects.

context: albuminuria is an important cardiovascular risk factor. arterial stiffness also gives important information about atherosclerosis. oscillometric methods may be useful in assessing arterial stiffness in a mainly operator independent way. objective: we aim to investigate the relationship between albuminuria and arterial stiffness measured with an oscillometric device in diabetic patients, hypertensive patients and healthy subjects. methods: 152 diabetic patients, 152 hypertensive patients and 152 healthy subjects are planned to be enrolled in this study. the measurements will be done between 9:00 and 13:00. after the measurements, blood and urine samples will be obtained, centrifugated and kept in -80°c until assayed. afterwards, echocardiographic left ventricle mass index will be calculated. the correlation between albuminuria and arterial stiffness will be assessed as the primary outcome measure.

Eligibility criteria:
inclusion criteria: * diabetes mellitus * hypertension * healthy subjects exclusion criteria: * symptomatic cardiovascular diseases (heart failure, history of myocardial infarction, etc.) * renal failure * pregnancy * diseases of the aorta

Keywords: diabetes mellitus hypertension albuminuria vascular stiffness
radiofrequency ablation in resectable colorectal lung metastasis

Conditions: Lung Metastasis; Colorectal Cancer

Summary: lung metastasectomy is the only therapeutic option to provide a long-survival in patients with colorectal lung metastases. recent studies have shown that radiofrequency (rf) ablation is a safe and useful therapeutic option for the treatment of unresectable lung metastases. in this phase-ii trial, clinical utility of lung rf ablation will be evaluated in patients with resectable colorectal lung metastases.

this will be a phase-ii clinical trial. lung metastasectomy is the only therapeutic option to provide a long-survival in patients with colorectal lung metastases. recent studies have shown that radiofrequency (rf) ablation is a safe and useful therapeutic option for the treatment of unresectable lung metastases. in this clinical trial, clinical utility of lung rf ablation will be evaluated. patients with resectable lung metastases will receive lung rf ablation. all subjects will be followed for overall survival, safety, change in respiratory function, cancer-specific survival, and local tumor progression.

Eligibility criteria:
inclusion criteria: * primary lesions (colorectal cancer) are resected. * lung metastases appear. * no extrapulmonary metastases or after locoregional treatments. * lung metastasis is considered to be controllable either by metastasectomy or radiofrequency (rf) ablation. * five or less lung metastases measuring 3cm or smaller. * pet study within 8 weeks before metastasectomy or rf ablation. * white blood count of 3000/mm3 or more. * platelet count of 100,000/mm3 or more. * hemoglobin level of 8.0 g/dl. * serum creatinine level of 2.0 mg/dl or less. * pao2 of 70 mm hg or more（room air）or spo2 of 93%. * serum bilirubin level of 2.0 mg/dl or less. * performance status of 0 or 1. * expected survival of 1 year or more. * age of 20 years or more. * informed consent from the patient. exclusion criteria: * risk to injure lung vessels 5 mm or larger. * lung metastases adjacent to the heart, trachea, esophagus, and aorta. * association of uncontrollable malignancies. * lung hilar lymph node metastasis. * one lung. * pulmonary hypertension. * coagulopathy. * impossible to stop using anticoagulants. * active infection or c-reactive protein of 3 or higher. * association of active inflammation. * fever (higher than 38 degrees celsius). * previous external-beam radiotherapy for the treated lung. * pregnant. * judgment to be an inappropriate candidate by a attending physician.

Keywords: colorectal cancer lung metastasis radiofrequency ablation metastasectomy lung metastasis from colorectal cancer
frequency effect of stn-dbs through the dual system on fog in pd

Conditions: Parkinson Disease

Summary: we aim to confirm the effect for fog by changing the frequency through the dual-system approach in pd patients after stn-dbs.

the investigators set two values of frequency (130, 60hz) in ipg and allow the patients to change the frequencies freely using the patient controller. after four weeks, the investigators will check the updrs part i, ii, iv, fog-q, and pdq-39 values at each frequency, including the proportion of use of two frequencies.

Eligibility criteria:
inclusion criteria: * patients with pd who are aged 30 years or older * patients with bilateral stn-dbs * patients who have a fog at their med "off" state in outpatient clinic or hospitalization, or updrs part ii fog subscore above 1 exclusion criteria: * patients without fog * patients who have undergone dbs * patients who have had previous brain surgery * patients who have undergone reoperation of dbs * patients who underwent unilateral dbs * patients with cognitive impairment (mmse \<18)

Keywords: parkinson disease, freezing of gait, deep brain stimulation
prehospital management of paroxysmal supraventricular tachycardia

Conditions: Tachycardia, Supraventricular

Summary: retrospective multicentre study on management of supraventricular tachycardia in prehospital setting.

supraventricular tachycardia in prehospital setting may be managed with adenosine administration or with synchronised electrical cardioversion and there's no clear advantage between the two, even if international guidelines suggests to practice drug-first method.this study aims to evaluate any difference in outcomes and efficacy of the two methods and possible adverse effects of both.

Eligibility criteria:
inclusion criteria: * patients accepting to participate * patients affected by supraventricular tachycardia that are managed prehospitally by the emergency medical service exclusion criteria: * not willing to participate, not able to give consent

Keywords: supraventricular tachycardia
different doses of oral melatonin supplements in chronic kidney disease (ckd)-associated sleep disorders

Conditions: End Stage Renal Disease; Chronic Kidney Disease; Sleep Disorder

Summary: the study will evaluate the safety and efficacy of melatonin supplementation in ckd and esrd patients with sleep disorders to reduce sleep latency times, the number of apnea/hypopneic episodes, and prolong duration in rapid eye movement (rem) sleep in ckd and esrd patients with sleep disordered breathing.

the study will look at the safety and efficacy of melatonin supplementation given to patients with chronic kidney disease and end stage renal disease who have sleep disorders to reduce sleep latency times, the number of apnea/hypopneic episodes, and prolong duration in rapid eye movement (rem) sleep in ckd and esrd patients with sleep disordered breathing.

Eligibility criteria:
inclusion criteria: 1. patient age \> 18 and \<85 years of age 2. patients with ckd or esrd with egfr \< 30 mls/min 3. if receiving hemodialysis, patients must be on treatment \> 3 months 4. normal healthy controls must be without a known history of ckd and be willing to have formal psg test and plasma melatonin measurements exclusion criteria: 1. patients receiving outpatient hemodialysis for \< 3 months 2. patients with estimated gfr by cockcroft gault \> 30 mls/min 3. patients receiving beta blocker therapy within one month of randomization 4. patients receiving nifedipine therapy within one month randomization 5. patients on peritoneal dialysis 6. patient with chronic home oxygen supplementation 7. patients receiving chronic home cpap therapy 8. patients actively receiving outpatient sleep medications 9. patients with diabetic gastroparesis unresponsive to medication 10. patients with known pregnancy or unwilling to use contraception during the course of the study 11. patients with a functioning renal allograft 12. patient currently receiving long-term immunosuppressive therapy. patients receiving low dose prednisone (10mg or less per day) will not be excluded from this trial 13. unable to give informed consent
an investigational immuno-therapy study of nivolumab given after surgery in non-small cell lung cancer (nsclc) participants with minimal residual disease

Conditions: Non-Small Cell Lung Cancer; Non-Small-Cell Lung Carcinoma; Circulating Tumor DNA

Summary: the purpose of this study is to determine if nivolumab added to the standard of care therapy (soc) given after surgery is more effective than soc alone in prolonging disease free survival in nsclc participants with minimal residual disease detected after surgery.


Eligibility criteria:
inclusion criteria prior to surgery: * suspected or histologically confirmed stage iia to iiib nsclc with disease that is considered resectable * must be deemed eligible for complete resection and must agree to undergo standard of care surgery for complete resection of nsclc * treatment naive (no previous systemic treatment) inclusion criteria prior to treatment randomization: * must have undergone complete surgical resection of their stage iia to iiib nsclc * must have adequately recovered from surgery at the time of randomization * minimal residual disease (mrd) positive results as detected by ctdna exclusion criteria prior to surgery: * participants with known egfr mutations which are sensitive to available targeted inhibitor therapy (prior to treatment randomization in select sites) * active, known or suspected autoimmune disease * participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization exclusion criteria prior to treatment randomization: * must continue to meet exclusion criteria prior to surgery * must have no evidence of metastatic disease after surgery * received a live/attenuated vaccine within 30 days of first treatment other protocol defined inclusion/exclusion criteria apply
improving hypertension control in the inner city

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to conduct a community based education program using existing resources to improve hypertension control in the inner city through multiple interventions.

background: the study was in response to a demonstration and education initiative, "improving hypertensive care for inner city minorities", which was reviewed and approved by the clinical applications and prevention advisory committee in april 1992 and by the national heart, lung, and blood advisory council in may 1992. the request for applications was released in october 1992. design narrative: the program consisted of a community wide education program, an intensive intervention directed toward individuals with hypertension, and an intervention for health care providers. the program was developed by a coalition of community organizations. in the community wide educational intervention, a baseline household survey was used to identify barriers to hypertension control in the community. this information was used in planning the intervention strategies, targeting the educational efforts, and developing the educational messages. existing community organizations (churches, local media, neighborhood organizations, etc) were used to implement educational efforts over a three year period. program success was evaluated by comparing findings on a follow-up household survey with those at baseline. level of blood pressure control was the primary outcome measure. for the intensive educational program for hypertensives, the investigators developed a hypertension registry of individuals with high blood pressure who were identified from a number of community sources. all individuals on the registry receive educational material through the mail. individuals with uncontrolled hypertension were randomized to receive the usual mailed educational materials or a more intensive personalized 12 month intervention using lay health advisors. in the evaluation, the investigators compared blood pressure control morbidity and mortality between these two intervention arms of the registry. the innovative educational approach to health care providers utilized the existing community-based area health education center (ahec) network to communicate community-determined hypertension control needs and community-determined hypertension control strategies to health care providers and students. the research was designed to elucidate community factors in the inner city that dictated strategies necessary for success in a variety inner city environments. specifically, the investigators examined the effect of community size and level of community stress (as indicated by poverty, crime, etc.) on program development and outcome. to do this, they implemented the program in one city-wide community (milwaukee) and in three well defined, homogeneous inner city neighborhoods of chicago which had differing levels of community stress indicators. they evaluated the effect of size and community stress levels on the program strategies and successes.

Eligibility criteria:
no eligibility criteria
an open study on the efficacy of iron therapy using iv iron relative to oral iron for increasing lv systolic function

Conditions: Myocardial Infarction; Iron-deficiency

Summary: the opera-mi trial evaluates the effect of i.v. ferric carboxymaltose compared to the effect of oral iron, on left ventricular systolic function.

for this study an open-label prospective randomized approach is used. during the study 360 patients with or without id, who hospitalized for myocardial infarction were signed up. patients were randomised (1:1) to either intravenous. fcm or oral ferrous sulphate and received the treatment during hospitalisation. patients are closely followed for 1 year. the primary outcome is a decrease in the wall motion score index value in fcm group compered to ferrous sulphate group. the main secondary outcome includes the composite of cardio-vascular mortality, non-fatal stroke, non-fatal mi, recurrent heart failure hospitalizations.

Eligibility criteria:
inclusion criteria: * adult (≥18 years of age) able to provide informed consent. hospitalized myocardial infarction patients (that diagnosed according to fourth universal definition of myocardial infarction and myocardial injury, esc 2018) with hypokinesia or akinesia in at least two connected left ventricular segments according to echocardiography results obtained within the first 24 hours after myocardial infarction occurs. * hemoglobin \>9.0 g/dl and \<15,0 g/dl and serum iron \<12 µmol/l on screening visit. * serum ferritin \<100 μg/l, or 100-299 μg/l when transferrin saturation \<20%. exclusion criteria: * known hypersensitivity reaction to any component of ferric carboxymaltose. * history of acquired iron overload, or the recent receipt (within 3 months) of erythropoietin stimulating agent, i.v. iron therapy, or blood transfusion. * heart failure killip class ii-iv on screening visit. * current or planned mechanical circulatory support or heart transplantation. * hemodialysis or peritoneal dialysis (current or planned within the next 6 months). * documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate transaminase \>3 times the upper limit of normal range). * current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia. * active gastrointestinal bleeding. * female participant of child-bearing potential who is pregnant, lactating, or not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication. * inability to return for follow up visits within the necessary period of time.

Keywords: myocardial infarction iron-deficiency wmsi ferric carboxymaltose left ventricular systolic function