Kornimate/medical-research-clean huggingface dataset:
safety and immunogenicity study of the hepatitis b virus (hbv) vaccine, heplisav compared to engerix-b vaccine

Conditions: Healthy

Summary: the purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis b virus vaccine, heplisav™, in healthy adults 40 to 70 years of age

the purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis b virus vaccine, heplisav™, in healthy adults 40 to 70 years of age

Eligibility criteria:
inclusion criteria: * be 40 - 70 years of age, inclusive * be seronegative for hepatitis b surface antigen (hbsag), antibody against hepatitis b surface antigen (anti-hbsag), antibody against hepatitis b core antigen (anti-hbcag), and human immunodeficiency virus (hiv) * be in good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation * if female of childbearing potential, agree to consistently use a highly effective method of birth control from screening visit through the treatment phase, for up to 28 days after the last injection exclusion criteria: * if female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy * has a history of or is considered by the investigator to be at high risk for recent exposure to hbv or hiv; for example, current intravenous drug use or has unprotected sex with known hbv/hiv positive partner * has a known history of autoimmune disease * has previously received any hepatitis b vaccine (approved or investigational)

Keywords: hbv vaccine hepatitis b vaccine hepatitis b hepatitis hbv prevention & control healthy healthy volunteers
nocturnal leg cramps in geneva : an observational study

Conditions: Sleep Wake Transition Disorders; Nocturnal Leg Cramps

Summary: background : nocturnal leg cramps (nlc) are defined as painful involuntary contractions of the lower limbs occurring during prolonged periods of rest, typically during the night. they may cause severe pain and sleep disturbance, and are particularly common among older adults, though they can occur in all decades of life. they are frequently unreported to physicians. to the investigators' knowledge, no epidemiological studies have been conducted in switzerland, but in a general population survey carried out in the uk (n=233), the overall prevalence of nlc was 37% and the disorder was more prevalent in older subjects (\>80 years old: 54%). of those who experienced nlc, 40% had cramps three or more times per week and 6% nightly. another study performed in older us veterans (n=515) showed that 56% suffered from nlc. the precise cause of these cramps is unclear. most nlc occurring in adults appear to be idiopathic, but potential contributing factors include low levels of certain minerals, extracellular fluid volume depletion and prolonged sitting or inappropriate leg position during sedentary activity. research question : what are the prevalence and the main features of nlc in patients consulting primary care physicians (pcps) in geneva, and how do pcps treat this affection? primary objective : to compute the prevalence of nlc in patients consulting pcps in geneva, explore its main features (number, duration, severity and sleep disturbance) and assess how pcps treat this affection. study design : prospective observational study using questionnaire and daily log completed by patients.


Eligibility criteria:
inclusion criteria: * patients of 50 years old or more, * currently presenting nlc (the definition of nlc used for the purpose of the study is any cramp in the legs or feet, occurring during the sleep (eg long rest) period). * coming to the practice for a planned consultation. exclusion criteria: * patients suffering from a terminal illness * from disorders affecting their ability to consent, * not speaking french * or not having a telephone.
improving informed consent for cleft palate repair

Conditions: Cleft Palate; Jaw Abnormalities; Maxillofacial Abnormalities; Mouth Abnormalities; Congenital Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities

Summary: to determine if providing a written document in addition to the standard oral discussion of surgical risks improves risk recall for the parents/guardians of a child seen in consultation for cleft palate surgery, and if this has any effect on overall satisfaction after the procedure

the current standard of care as it relates to informed consent in the pediatric population involves providing the parents or guardians of the child undergoing surgery with an oral discussion prior to the surgical procedure. however, providing parents with an oral discussion alone may be insufficient in the informed consent process as it has been shown that oral information tends to be retained poorly and crucial pieces of information tend to be forgotten. conversely, it has been shown that properly informed patients are more satisfied, have a higher commitment to their treatment, and demonstrate less tendency toward filing legal claims. furthermore, written material may help reduce anxiety in patients facing stressful events, such as surgery, and have been linked with overall improvement in satisfaction with their treatment the investigators hypothesize that providing a written document in conjunction with the standard oral discussion improves the participants' risk recall in the informed consent process for their child's cleft palate repair surgery and increases their subjective satisfaction with the operation.

Eligibility criteria:
inclusion criteria: * parents/guardians of a child referred to the iwk cleft palate clinic for primary cleft palate repair surgery exclusion criteria: * inability to fluently communicate in english * inability to read at a grade 8 level * inability to provide informed consent

Keywords: risk recall pamphlet brochure patient satisfaction informed consent
metabolomic markers of fatigue in inflammatory bowel disease

Conditions: Fatigue; Inflammatory Bowel Disease; Ulcerative Colitis; Crohn Disease

Summary: fatigue is a common symptom and a leading concern in patients with inflammatory bowel disease (ibd) and often persists despite clinical and endoscopic remission. this study evaluates the metabolomic profile of fatigued patients with ibd.

to date, there is only one non-published study using metabolomics in quiescent ibd patients with and without fatigue. the investogators designed this study to examine if there are metabolomics factors associated to fatigue in ibd patients. this study was performed with plasma samples from ibd patients recruited in a previous study after informed consent. (1) ibd outpatients attending the hospital de sabadell gastroenterology day-care unit were consecutively included for analytical monitoring of immunosuppressant treatment or infliximab infusion. the investigators recorded demographic data, ibd classification according to the montreal classification, and history of drug administration. in addition, clinical activity of the disease was measured using the harvey-bradshaw score for crohn's disease (cd) and the modified mayo score for ulcerative colitis (uc). the "functional assessment of chronic illness therapy-fatigue" (facit-f) was used to assess fatigue.

Eligibility criteria:
inclusion criteria: - inflammatory bowel disease diagnosed at least 6 months before the study (diagnosed by clinical, laboratory , endoscopic and histological criteria) . exclusion criteria: * age below 18 years. * refusal to give written informed consent prior to participation * active infection at the time of inclusion. * concomitant diseases not related to ibd (e.g., cancer, heart disease, pulmonary disease) that might contribute to the presence or the severity of fatigue. * active flare of ibd in the last 3 months.
in.pact™ quality of life post-reimbursement study

Conditions: Obstructive Disease; Atherosclerosis of Femoral Artery; Atherosclerosis of Popliteal Artery

Summary: to prospectively collect and assess the perception of health-related quality of life, pain and walking ability.

to provide both the french national authority for health and the french economic committee for health products requested information on patient-reported outcomes for the in.pact™ admiral™ drug-coated balloon. patients will be followed using routine clinical practice and the collection of two validated instruments: euroqol eq-5d quality of life questionnaire and the walking impairment questionnaire (wiq).

Eligibility criteria:
inclusion criteria: * patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * patient has or is intended to receive or be treated with an eligible product * patient is consented within the enrollment window of the treatment/therapy received exclusion criteria: * patient who is, or is expected to be inaccessible for follow-up * patient with exclusion criteria required by local law * patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness) note: for this study, de novo patients will be enrolled to assess eq-5d and wiq at baseline and follow-up. patients cannot be treated in the same procedure with a competitor drug-coated (dcb) or drug-eluting (des) in the vessel segment treated with in.pact admiral.
prophylactic amiodarone for shockable cardiac arrest

Conditions: Cardiac Arrest; Ventricular Arrythmia

Summary: the aim of this study is to determine whether the prophylactic amiodarone can prevent re-arrest with ventricular shockable rhythm in patients who treated with targeted temperature management after return of spontaneous circulation from cardiac arrest which had been shockable rhythm during cpr.

patients with cardiac arrest are in high risk of re-arrest during post cardiac arrest care due to vulnerable heart state electrically and hemodynamically. especially if patients who had experienced shockable rhythms such as ventricular fibrillation or pulseless ventricular tachycardia during cpr, then they are at high risk of developing shockable re-arrest. however until now there has not been any evidence of prophylactic anti arrhythmic drug effect during post cardiac arrest care. amiodarone is class iii anti arrhythmic drug which has been used for conversion of ventricular arrhythmia during cpr. in this study we want to determine whether the prophylactic amiodarone can prevent re-arrest with ventricular shockable rhythm or not.

Eligibility criteria:
inclusion criteria: * non traumatic cardiac arrest patients who had vf or pvt during cpr in er exclusion criteria: * age \< 18 yr * pregnancy * non cardiac caused arrest such as hanging * previous amiodarone continuous infusion before radomization * sustained ventricular arrhythmia recurrence after rosc * extracorporeal membrane oxygenation * contra indication for amiodarone * disagree with this research
pressurewire study

Conditions: Coronary Artery Disease; Acute Coronary Syndrome

Summary: the purpose of this study is to understand routine use of ffr (fractional flow reserve) and alternate indices in clinical practice. this study will determine the use and clinical outcome of ffr-guided pci in patients presenting with either stable coronary artery disease, or in patients presenting with acute coronary syndrome (acs) on culprit and non-culprit lesions as well as during index and secondary procedures.

the purpose of this study is to understand routine use of ffr and alternate indices in clinical practice. this study will determine the use and clinical outcome of ffr-guided pci in patients presenting with either stable coronary artery disease, or in patients presenting with acute coronary syndrome (acs) on culprit and non-culprit lesions as well as during index and secondary procedures. the study will also collect data on the routine use of coronary physiologic measurements such as adenosine-induced hyperemia ffr, ffr by contrast-induced hyperemia,

Eligibility criteria:
inclusion criteria: * patient is presenting with stemi, nstemi, unstable angina, or stable coronary artery disease * patient is planned to have ffr performed or underwent a cardiac catheterization where ffr was performed for further pci (percutaneous cardiac intervention) consideration * patient signs and dates written informed consent * patient is eighteen years of age or older at the time of consent exclusion criteria: * patient has extremely tortuous or calcified coronary arteries * patient with a patent coronary artery bypass graft to the target vessel

Keywords: ffr percutaneous coronary intervention
cabozantinib (xl184) in men with castrate-resistant prostate cancer

Conditions: Prostate Adenocarcinoma

Summary: cabozantinib (xl184) is a new drug that is being developed to treat cancer. cabozantinib works by blocking the "angiogenesis," or the growth of new blood vessels, to the tumor. this is similar to how several other cancer drugs work but in addition cabozantinib also blocks other pathways that may be responsible for allowing cancer cells to become resistant to these other "anti-angiogenic" treatments. so far cabozantinib has been investigated in treating brain cancer and a rare form of thyroid cancer. this study will explore lower doses of cabozantinib with the goal to find the most effective, safe, and tolerable dose without undesirable side effects.

cabozantinib will be taken by mouth daily. the first five treatment cycles will be 21 days. all cycles after that will be 42 days long. patients will keep a diary to record study drug dosing. during the screening phase patients will receive a physical exam, blood and urine tests, a bone scan, a ct of the abdomen and pelvis, and an mri scan of total body. on day 1 of each cycle patients will receive a physical exam and blood and urine tests. bone scan, ct and mri scans will be performed at the start of cycles 3 and 5, and then repeated once every 12 weeks. patients will continue to receive study treatment as long as they are receiving benefit from the treatment, do not experience any severe or unmanageable side effects, and disease does not get any worse.

Eligibility criteria:
inclusion criteria: * histologically confirmed prostate adenocarcinoma * bone metastases confirmed by bone scan * current androgen deprivation therapy * castration-resistant disease based on progression in bone and/or psa progression * recovered from toxicities related to prior treatment, except alopecia, lymphopenia, other non-clinically significant adverse events * life expectancy of greater than 3 months * normal organ and marrow function * capable of understanding and complying with the protocol requirements * agree to use medically accepted methods of contraception * able to swallow capsules exclusion criteria: * more than two prior chemotherapy regimens for metastatic prostate cancer * known untreated, symptomatic or uncontrolled brain metastases * serious or unhealed wound * treatment with anticoagulants * previously identified allergy or hypersensitivity to components of the study treatment formulation * history of a different malignancy unless disease-free for at least 5 years, or basal or squamous cell carcinoma of the skin * current antiretroviral therapy * uncontrolled hypertension * uncontrolled intercurrent illness

Keywords: prostate cancer castration resistant bone metastases
multicenter registry for angiography-derived quantitative flow ratio

Conditions: Ischemic Heart Disease

Summary: 1. to investigate the feasibility and diagnostic performance of contrast quantitative flow ratio (qfr) for identifying the functional significance of intermediate degree stenotic lesions in all-comer patients with coronary artery disease (cad) including presentation of acute myocardial infarction (ami) with non-culprit lesion. 2. to compare the changes of contrast qfr and fractional flow reserve (ffr) according to severity of percent diameter stenosis (%ds) 3. to evaluate prognostic implication of contrast qfr in comparison with ffr

despite potential clinical benefits and abundant evidences of ffr-guided percutaneous coronary intervention (pci), adoption rate of ffr is still low in real world practice, most likely due to use of additional resource and to concern about side effects of hyperemic agent. therefore, several tools to derive ffr non-invasively has been developed based on computational fluid dynamics to overcome the limitations. one of the novel methods, the contrast quantitative flow ratio (qfr) is a computation of ffr based on 3-dimensional quantitative coronary angiography (qca) combined with thrombolysis in myocardial infarction (timi) frame counts adjustment without hyperemic agent infusion. although diagnostic performance of contrast qfr for evaluation of functional significance, using ffr as reference standard, is well validated in patients with stable ischemic heart disease (sihd), there have been lack of evidence regarding the reliability of qfr for non-culprit stenosis in patients with ami. therefore, the investigators sought to investigate the feasibility and diagnostic performance of contrast qfr for identifying the functional significance of coronary stenosis in all-comer patients with cad. in addition, prognostic implication of contrast qfr will be also compared with that of ffr.

Eligibility criteria:
inclusion criteria: * subject must be ≥18 years * patients suspected with ischemic heart disease * patients with intermediate degree of coronary artery stenosis (40-70% stenosis by visual estimation) in major epicardial coronary artery with ffr measurement * patients who were able to analyze qfr * subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and he/she or his/her legally authorized representative provides exclusion criteria: * left main (lm) or right coronary artery (rca) ostial lesion * severe overlap of stenotic segments * severe tortuosity of target vessel * poor angiographic image quality precluding contour detection * no optimal images with angles ≥ 25o

Keywords: stable angina acute myocardial infarction fractional flow reserve quantitative flow ratio
a study of mircera in participants with chronic kidney disease stage 3-4 and not on dialysis

Conditions: Anemia

Summary: an observational, longitudinal, multi-center, non-interventional study in participants with chronic kidney disease (ckd) stage 3-4, assessed by modification of diet in renal disease (mdrd) to collect data regarding safety and efficacy in participants with pre-dialysis situation who are treated with mircera in normal clinical environment.


Eligibility criteria:
inclusion criteria: * adult participants above 18 years of age * pre-dialysis participants with ckd stage 3-4 treated with mircera and continue in the pre-dialysis state for the whole study period * estimated glomerular filteration rate (e-gfr) between 15-60 milliliter per minute (ml/min) (calculated) exclusion criteria: * participants involved in interventional trials * participants with life expectancy less than 1 year * active malignancy * planned living kidney transplant within 6 months.
probiotic versus placebo as adjuvant for bacterial vaginosis treatment during pregnancy

Conditions: Bacterial Vaginosis

Summary: bacterial vaginosis is a common vaginal condition involving a reduction in the amount of lactobacilli, the normal bacteria colonizing the vagina, and an overgrowth of pathogenic bacteria. the presence of bacterial vaginosis in pregnancy is associated with an increased risk of preterm delivery. after a course of antibiotic treatment, recurrence of bacterial vaginosis has been reported in 10-70% of cases. this study aims to verify if administration of vaginal lactobacilli may reduce the occurrence rate after antibiotic treatment of bacterial vaginosis during pregnancy.


Eligibility criteria:
inclusion criteria: * singleton pregnancy * gestational age 12-32 weeks * diagnosis of bacterial vaginosis * treatment of bacterial vaginosis with oral clindamycin 300 mg, twice-daily for 7 days exclusion criteria: * multiple pregnancy * allergy to clindamycin
observance of long term oxygen therapy in chronic inspiratory disease patients

Conditions: Chronic Respiratory Disease; Hypoxemia

Summary: long-term oxygen therapy (ltot) is the reference treatment for chronic respiratory failure. this treatment is based on the principle of oxygen supplementation via a source to correct hypoxemia in patients. at present, adherence to this treatment is difficult to evaluate (reporting by patients), but the results of the literature show poor ltot compliance. it is therefore important to accurately measure the oxygen consumption by patients and to understand the factors explaining ltot compliance. the ultimate aim is to improve our patient management to make them more observant in order to improve the therapeutic efficacy of the treatment.


Eligibility criteria:
inclusion criteria: * chronic respiratory disease patients with chronic hypoxemia * first prescribed long term oxygenotherapy exclusion criteria: * patients with niv and cpap * vital pronostic \< 3 months
colonic resections in patients with suspected appendicitis

Conditions: Colectomy; Appendicitis

Summary: although many reports have been published on colonic resections in patients with suspected appendicitis and the diseases that cause the decision to resect the colon have been identified and their proper treatments have been established, there is no report on the risk factors present in converting a simple appendectomy into a major colonic resection. the investigators aimed to identify the risk factors that lead the surgeon to perform a colonic resection in patients undergoing surgery for initially suspected acute appendicitis.


Eligibility criteria:
inclusion criteria: * patients older than 15 years of age * male or female * suspected of having acute appendicitis * converted to right hemicolectomy exclusion criteria: * patients in whom a right hemicolectomy was planned initially * right hemicolectomy for causes other than suspected acute appendicitis

Keywords: acute appendicitis colonic diverticulitis colonic tumors colonic resections