Kornimate/medical-research-clean huggingface dataset:
human papillomavirus vaccine immunogenicity and safety trial in young adult women with gsk biologicals novel hpv vaccine

Conditions: Infections, Papillomavirus; Papillomavirus Vaccines

Summary: infection with human papillomavirus (hpv) has been clearly established as the central cause of cervical cancer. indeed, certain oncogenic types of hpv can infect the cervix (part of the uterus or womb). this infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. glaxosmithkline biological's has developed a hpv vaccine against the oncogenic types hpv-16 and hpv-18 formulated with the as04 adjuvant (control vaccine) and is also evaluating novel hpv vaccines formulations. this study will evaluate the long-term immunogenicity and safety of a novel gsk biological's vaccine in approximately 376 subjects who received the novel vaccine or the control vaccine administered in the primary study. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.


Eligibility criteria:
inclusion criteria: * a female who enrolled in the study 102115 and received three doses of vaccine. * written informed consent obtained from the subject prior to enrolment. exclusion criteria: * use (or planned use during the study period) of any investigational or non-registered product or off-label use of licensed product (drug or vaccine). * chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling. * administration of immunoglobulins and/or any blood products within the three months preceding blood sampling. * planned administration of any hpv vaccine, other than that foreseen by the study protocol, during the study period.

Keywords: hpv vaccine
reliability and cross-cultural adaptation of the turkish version of the neuropathic pain symptom inventory

Conditions: Neuropathic Pain

Summary: in this study, investigators want to perform the reliability and cross-cultural adaptation of the turkish version of the neuropathic pain symptom inventory

the purpose of the study is to determine the turkish version, the reliability and cross-cultural adaptation of the turkish version of the neuropathic pain symptom inventory. 120 patients with neuropathic pain will be included in the study. test-retest and internal consistency analysis were conducted to determine the reliability of the questionnaire. test-retest results evaluated using the intraclass correlation coefficient method.

Eligibility criteria:
inclusion criteria: * age upper 18 * complaints of neuropathic pain for at least 3 months exclusion criteria: * presence of psychiatric illness * cancer pain, unsuccessful lumbar surgeon syndrome etc. mix type pain presence * presence of complex regional pain syndrome * cognitive impairment (mini-mental test score \<24) * native language is not turkish
how smoking causes copd: examination of immune system changes

Conditions: Chronic Obstructive Pulmonary Disease

Summary: a breathing condition known as "chronic obstructive pulmonary disease" (copd) caused by cigarette smoking is a major health problem. the way by which smoking leads to lung disease is uncertain. recent research done in animals provides a description of specific changes (that is a reduction) in these immune cell types as a result of cigarette smoke exposure. the study you have been asked to participate in is a pilot study to see if similar changes occur in humans who smoke. the purpose of this study is to evaluate this new method of testing blood in 3 groups of 10 people: normal non-smoking subjects, subjects who smoke with no history of lung disease and subjects who smoke and have smoking related copd.

the mechanism by which smoking leads to damage to lung tissue in susceptible hosts, is uncertain. recently there has been description of specific changes (that is reduction) in the number and activity of certain key immune cell types - dendritic cells- as a result of cigarette smoke exposure. this work was done in animal models and we would like to develop methods that will allow us to examine if similar changes occur in humans who smoke. reduced number and activity of dendritic cells would be expected to lead to increased incidence of infection - a common problem in patients with copd. since dendritic cells come to the lung from the bloodstream, and one can detect them in the circulation, we will look at the dendritic cells that are present in the peripheral blood.

Eligibility criteria:
inclusion criteria: * age \> 40 years * healthy subjects - non smokers * fev1/fvc \> 70% predicted * current smokers - \> 10 pack year smoking history * fev1/fvc \> 70% predicted * current smokers with copd - \> 10 pack year smoking history * fev1/fvc \< 70% predicted * able to give informed consent exclusion criteria: * healthy subjects - reside with smokers * history of lung disease * current smokers - history of lung disease

Keywords: chronic obstructive pulmonary disease smoking related disease immune system changes
tele-rehabilitation intervention for people post hip fracture - pilot study

Conditions: Hip Fractures

Summary: most surviving hip-fracture patients experience reduced mobility and lose their functional ability, which increases the risk of complications and rehospitalization. post-discharge transitional programs to reduce readmissions have shown some success. telerehabilitation refers to the use of technologies to provide rehabilitation services to people in their homes. considering the need for long-term follow-up care for people with hip fracture, in-home telerehabilitation could increase independence, decrease hospital stays and reduce the burden for caregivers. the purpose of the pilot study is to examine the feasibility and acceptability of the research methods evaluating telerehabilitation with adults who have experienced hip fracture, in preparation for a larger randomized controlled study. a one-group (n=6) pre-test/post-test design is currently being constructed. results of the pilot study will be used to determine what adaptations to the design may be required to ensure successful implementation. recruitment, retention and attendance rates, as well as percentages completing the outcome measures, will be examined to plan the time frame of the main trial. the intervention will include 10 videoconferencing sessions from an occupational therapist in the presence of the primary caregiver. each session will be utilized to guide the participants to achieve their self-identified goals, focusing on problem-solving for daily life situations and on the ability to implement the discussed strategies for a variety of activities.


Eligibility criteria:
inclusion criteria: * older adults (age ≥60 years) * post hip fracture - discharged from the inpatient rehabilitation unit of herzog hospital, jerusalem, between january 2017 and december 2017. * discharge from rehabilitation to a non-institutionalized setting. * broadband or wi-fi in their home and must be able to operate an ipad independently. * fim\>90 at discharge. * has a designated caregiver (a close friend, family member, or support worker) aged over 18, and a hebrew, english or arabic speaker, who will agree to cooperate in the research. exclusion criteria: * aphasia. * cognitive impairment (montreal cognitive assessment scores : moca\<19 or mmse\<21). * degenerative neurological diagnoses. * current major depressive or psychotic disorder. * other acute or chronic health condition that will influence their ability to participate in the study.

Keywords: telerehabilitation occupational therapy rct participation quality of life intervention older adults
action selection and arm rehabilitation after stroke

Conditions: Stroke

Summary: after stroke, individuals often have persistent difficulty using the arm and hand in everyday functional tasks that reduces quality of life. currently available rehabilitation techniques are not adequate and new protocols are needed that are based on an understanding of how brain regions work together to produce skilled movement. this research project aims to improve our understanding of how the brain controls movement after stroke and determine whether a period of motor practice that targets specific brain regions through the addition of action selection demands leads to improved arm function. we hypothesize that arm motor function and the ability to efficiently activate the action selection motor circuit during movement will improve after training.

rehabilitation of arm impairment after stroke includes the repetitive practice of functional tasks. in healthy adults, planning plays a vital role in the control of skilled movement, however, the behavioral and neural correlates of planning have largely been unexplored in individuals recovering from stroke. action selection is an important motor planning process that engages dorsal premotor cortex (pmd) in controls. while pmd activation is a commonly reported neural correlate of motor recovery after stroke, the role of pmd in action selection and motor training are not known. therefore, the purpose of this study is to determine the effect of training that includes action selection demands on the behavioral and neural correlates of movement after stroke. thirty-eight individuals in the chronic phase of stroke will be recruited. after completion of clinical measures of impairment and function, all participants with stroke will complete a motor action selection task and functional mri followed by arm training. arm training will consist of three weeks (15 sessions) of arm motor training (1.5 hours per session) that includes action selection demands on movement. follow-up clinical testing will occur at the end of treatment and three weeks later.

Eligibility criteria:
inclusion criteria: * at least 18 years old * had stroke at least 6 months ago * right-hand dominant prior to stroke * some continued arm and hand weakness * some ability to move the arm and hand that is weaker from the stroke exclusion criteria: * acute medical issues that would interfere with participation * another neurologic diagnosis that may impact movement (e.g. parkinson's disease) * cannot undergo mri scanning * severe apraxia or hemispatial neglect * pain in the arm that interferes with movement * difficulty maintaining attention or following directions

Keywords: rehabilitation upper extremity physical therapy
safety and effectiveness of giroctocogene fitelparvovec or fidanacogene elaparvovec in patients with hemophilia a or b respectively

Conditions: Hemophilia A; Hemophilia B

Summary: a study to learn about the long-term safety and efficacy of giroctocogene fitelparvovec or fidanacogene elaparvovec in patients with hemophilia a or hemophilia b respectively, who have received treatment through prior participation in a pfizer-sponsored clinical trial. data collection and participant visits will be based on standard of care.


Eligibility criteria:
inclusion criteria: -only participants who received investigational giroctocogene fitelparvovec or fidanacogene eleparvovec and were enrolled in a pfizer-sponsored study (c0371002, c0371003, c0371005, c3731001, c3731003) are eligible. exclusion criteria: -none

Keywords: bleeding adeno-associated virus based vector gene therapy giroctocogene fitelparvovec fidanacogene elaparvovec factor viii factor ix
phase ii study of al-2178 (fid 109980) in the treatment of dry eye

Conditions: Dry Eye

Summary: the purpose of this study is to see if rimexolone (fid 109980) is a safe and effective treatment of dry eye.


Eligibility criteria:
inclusion criteria: * documented dry eye history * ocular symptoms * tear use * dry eye ocular signs exclusion criteria: * under 18
omega-3 supplementation for liver volume reduction study (oliver) study

Conditions: Fatty Liver; Bariatric Surgery Candidate

Summary: omega-3 has been postulated to reduce hepatic steatosis by reducing lipogenic gene expression, exerting anti- inflammation action, reducing oxidative stress and improving glycemic control. a recent meta-analysis by parker et al.\[1\] found that omega-3 supplementation is associated with improvement in liver fat content as well as on aspartate aminotransferase (ast) levels. omega-3 supplementation has also found to be useful in reducing blood triglyceride levels \[2\]. recent studies by iannelli et al. (2013) and abidin et al.(2017) have also found that a 1 month supplementation of 1.5g/day and 2g/day of omega-3 supplementation resulted in reduced hepatic volume of 20% and 34.88 cm3 respectively. the investigator's hypothesis is that a 4 weeks course of omega-3 (2 capsules of blackmores omega daily concentrated fish oil per day; each capsule concentrated omega-3 triglycerides- fish 1000mg containing omega-3 marine triglycerides 600mg as: 360mg eicosapentaenoic acid (epa), 240mg docosahexaenoic acid (dha)) taken as supplement, without any other dietary intervention pre bariatric surgery decreases significantly liver volume and facilitate access during surgery. and that shrinkage of liver volume also translates to improve biochemical parameters of fatty liver disease

a total of 50 subjects booked for bariatric surgery with bmi up 45 will be recruited. patients with pre-existing liver disease, excessive alcohol consumption and significant central obesity will be excluded. ultrasound examination of the liver with liver volume measurement, and blood tests, including liver function tests (lft) and platelet counts,is performed as part of the pre surgery work up. the subjects are then given 4 weeks of omega-3 supplements (2 capsules of blackmores omega daily concentrated fish oil per day: concentrated omega-3 triglycerides- fish 1000mg (600mg eicosapentaenoic acid (epa), 1400mg docosahexaenoic acid (dha)). just before surgery, a repeat of ultrasound examination and measurement of liver volume is carried out, as well as a repeat liver panel and platelet count.the subjects will have their weight and body composition recorded as well at this time. at the time of the surgery, the surgeon makes a subjective assessment of the left lobe liver volume on a scale of 1 to 5, 5 being the largest. additionally,ease of access to area under the left lobe of the liver is also subjectively assessed, on a scale of 1 to5, 5 being the most difficult.

Eligibility criteria:
inclusion criteria: * subjects qualifying and scheduled for bariatric surgery (as according to singapore health promotion board- ministry of health obesity clinical practice guidelinejune 2016) * bmi \<45 with no significant central obesity. * has no pre-existing liver disease, or excess alcohol consumption. exclusion criteria: * pre-existing liver disease * excessive alcohol consumption * prior history of allergy to omega-3 products, salmon or other- related products * central obesity * pregnant

Keywords: omega 3 bariatric surgery fatty liver vlcd
therapeutic exploratory study of cwp-0403

Conditions: Type 2 Diabetes Mellitus

Summary: objective of the trial is to assess dose-dependency, efficacy and safety and to estimate optimum dosage for confirmatory study of cwp-0403 50mg, 100mg given twice daily for 12 weeks to type 2 diabetes patients who are insufficiently controlled by diet and exercise in comparison to placebo.


Eligibility criteria:
inclusion criteria: * age of≥25 and \<75 with typeⅱ dm patients * patients whose level of hba1c is over 7.0% and less than 10% within 4weeks of screening registration * in spite of dietary and exercise treatment over 8weeks, the level of hba1c is over 6.5% and less than 10%. * bmi between 20kg/㎡ and 40kg/㎡ * out patients * patients who agree the trial participation with written informed consent exclusion criteria: * typeⅰdm, gestational diabetes. * patients who are being treated with insulin * fasting glucose level over 250mg/dl * patients who are not compliant with dietary and exercise treatment during 8 weeks of screening period. (evaluated "bad" and worse) * severe hepatic dysfunctions (i.e.: uncompensated hepatic cirrhosis)or ast or alt level over 2.5times as high as unl on screening visit. * severe renal dysfunctions (i.e.: renal failure) or serum creatinine level over 1.5mg/dl * severe cardiac dysfunction(i.e.: heart failure ) or history of myocardial infarction within 6months of screening * chronic pulmonary disease or pulmonary infarction * pancreatitis patients * patients who are being treated for life threatening disease such as cancer, severe trauma or infection. * uncontrollable diabetic complications(neuropathy, retinopathy, nephrosis) * severe ketosis or experience of diabetic coma * intestinal disease affecting digestion or absorption or history of gi dissection surgery except for appendectomy. * pregnant, expecting to be pregnant or nursing female * excessive alcohol consumption (over 80g of alcohol/day: over 1 bottle of 360ml soju/day) * participants of other clinical trials within 3 months of screening * patients medicated with following non-concomitant medications insulins or oral antidiabetics oral (for more than 1 week) or iv corticosteroids (external and inhaled corticosteroids excluded) appetite suppressant exenatide or other glp-1 analogues other medications in development * hypersensitive or intolerance to dpp4 inhibitory * patients who are decided to be inappropriate for this trial subject by the investigators
study to evaluate the safety of long-term use of perforomist® (formoterol fumarate)

Conditions: COPD

Summary: this study is a multi-center, randomized, placebo-controlled study to evaluate the long-term safety of perforomist® inhalation therapy in subjects with chronic obstructive pulmonary disease (copd). individual participation is approximately 54 weeks, including 52 weeks of double-blind treatment.

none provided.

Eligibility criteria:
inclusion criteria: 1. able to understand the study requirements, provide written informed consent, and agree to abide by the study protocol and its restrictions 2. male and female subjects at least 40 years of age with a medical diagnosis of copd (i.e. persistent presence of dyspnea, cough or sputum production and a history of exposure to risk factors for the disease, such as tobacco smoke) 3. a current or prior history of at least 10 pack-years of cigarette smoking and a baseline breathlessness severity grade of \>=2 (modified medical research council \[mmrc\] dyspnea scale score) at randomization. 4. women of child-bearing potential (wocbp) must have a negative pregnancy test at the screening visit and agree to avoid becoming pregnant for the duration of study by using adequate contraception at study entry and throughout the trial. wocbp will be advised to notify the investigator of any change in their pregnancy status. wocbp include: any female who has experienced menarche and is not post-menopausal (defined as amenorrhea for at least 12 consecutive months), or has not undergone surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation). women who are using acceptable contraceptive medications or devices to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy) will be considered wocbp. 5. able to complete all aspects of the study through the end of the study, including all visits and tests, and self-administration of study medications. exclusion criteria: 1. a medical diagnosis of asthma. indication of a past history of asthma that is deemed inaccurate to a subject's current condition by the investigator must be adequately addressed in the medical history. 2. clinically significant abnormal chest x-ray (cxr) (within the past 12 months) diagnostic of active/significant disease other than copd. 3. evidence of any unstable or clinically significant hematopoietic, malignant, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disorder, or condition or disease other than copd that, in the opinion of the investigator, could place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives. 4. subjects who had radiation or chemotherapy within the previous 12 months. 5. an abnormal laboratory test at screening deemed clinically significant and exclusionary by the investigator. 6. a history of hypersensitivity to study drugs or their components, including albuterol rescue. -
the cognitive effects of lorazepam in healthy older individuals with tomm40 variable-length polymorphisms

Conditions: Alzheimer's Disease (AD)

Summary: the investigators' goal is to determine if certain tests of memory and attention, performed while sleepiness is induced by a single dose of lorazepam, can predict whether or not an individual is at risk for developing alzheimer's disease.


Eligibility criteria:
inclusion criteria: * mini-mental state examination (mmse) score of 28-30 * hamilton depression rating scale score of less than 10 * participants in longitudinal study of aging and have a tomm40 genotype of s/s, vl/vl, s/vl, l/s or l/vl. exclusion criteria: * alzheimer's disease or mild cognitive impairment * any significant medical, psychiatric, and neurological illnesses, e.g., impaired liver or kidney function, prior stroke, traumatic brain injury, memory impairment, cognitive impairment, parkinsonism, a lifetime history of schizophrenia, bipolar disorder, a psychoactive substance use disorder, or current major depression. * known allergy to benzodiazepines * current use (within the previous four weeks) of benzodiazepines or other medications known to interact with lorazepam, current use of sedating antihistamines, or current use of stimulant medications

Keywords: alzheimer's disease (ad)
entegral artificial larynx clinical trial

Conditions: Total Laryngectomy

Summary: the objective of this clinical study is to evaluate the feasibility, safety and efficacy of the entegral artificial larynx (al) in patients indicated for total laryngectomy.


Eligibility criteria:
inclusion criteria: * age more than or equal to 18 years old * is indicated for total laryngectomy (first intention) * must be able to comply with study requirements * must be able to understand and be willing to provide written informed consent exclusion criteria: * any condition that precludes the implantation of the entegral al * existing coagulation disorder * contraindication for general anesthesia * tumoral extension outside of the larynx invading through extra-laryngeal structures * previous radiotherapy * life-expectancy \< 12 months * be pregnant of breastfeeding or intention to becoming pregnant during study