Kornimate/medical-research-clean huggingface dataset:
local analgesia to prevent pain in patient undergoing removal of the uterus through vaginal route

Conditions: Pain, Postoperative

Summary: following a hysterectomy, women tend to experience high levels of pain, and many require strong pain killers after the procedure. ropivacaine is a local anaesthetic drug (injectable numbing medication) which works by blocking pain signals. the aim of this study is to find out whether injections of ropivacaine during surgery can help provide effective pain relief after surgery.women aged between 45 and 70 who are having a vaginal hysterectomy can participate in the trial. participants are randomly allocated to one of two groups. those in the first group are given injections of ropivacaine at the site of the wound and in the peritoneum (space in the body that holds the organs in the abdomen) and those in the second group are given injections of a saline fluid in the same places that offers no pain relief before the end of their surgery. participants in both groups are then regularly asked to rate their pain levels up to 24 hours after surgery. in addition, the pain killers they receive and length of hospital stay are recorded. there is a chance that the participants who receive the ropivacaine will benefit from lower pain levels after surgery. there are no notable risks of participating.

at end of the vaginal hysterectomy operation, the gynecologist will inject the uterosacral, cardinal ligaments, adnexal areas and the vaginal edge with 15 ml of either the ropivacaine solution or the placebo fluid in each side, then 20 ml will be instilled inside the peritoneum. analgesia will be given on request after operation. visual analogue score of 0 to 100 mm will be used to assess the degree of pain, with 0 indicating no pain and 100 indicating worst pain.

Eligibility criteria:
inclusion criteria: 1. female 2. 45 to 70 years old 3. scheduled for ndvh (non descent vaginal hysterectomy) for benign indications without need for oophorectomy or vaginal reconstructive surgery exclusion criteria: 1. patient weight less than 50 kg 2. allergy to amide local anesthetic 3. dementia or mental retardation to a degree which would interfere with data collection 4. contraindication to non descent vaginal hysterectomy
a retro-prospective study of total hip arthroplasty with emperion modular primary stem in australian centres (historic)

Conditions: Osteoarthritis, Hip; Arthritis, Degenerative

Summary: this is a retro-prospective, single arm, sequential enrolment study to collect relevant clinical and radiological data in at least 156 subjects, at up to 10 sites in australia, who have been implanted with the emperion™ modular hip system in primary tha procedures to assess its safety and efficacy over 5 years post-surgery.

the main aim of the study is to demonstrate that there is no significant difference in survivorship at 5 years in the emperion™ primary stem compared to other primary stems for total hip arthroplasty. investigational site personnel will review and screen clinical records for potential subjects to be included in the study. eligible patients will be contacted and follow-up status and implant revision status will be assessed at this initial contact. the subject will be given the option to participate in a prospective 5-year on-site follow-up visit for which they will provide written informed consent. an hrec waiver of informed consent for study participation will be obtained for subjects who are lost to follow-up, deceased or are unwilling/unable to participate in a prospective on-site 5-year follow-up visit, allowing the inclusion of data from all patients implanted with the study device regardless of follow-up status and therefore eliminate selection bias. data will be collected retrospectively from the subject pre-surgery, during surgery, at discharge and at 1-year follow-up found in their medical files and prospective data will be collected from the subject's 5-year follow-up visit and documented on specially designed case report forms (crfs). data to be collected include: * subject demographics * primary diagnosis for tha * additional relevant history and physical findings * post-operative follow-up findings at 1 and 5 years * radiological assessment * revision by time points * adverse events

Eligibility criteria:
inclusion criteria: 1) subject has undergone primary total hip arthroplasty with the emperion™ modular hip system exclusion criteria: 1. subject received the emperion™ tha on the affected hip as a revision for a previously failed tha 2. at the time of surgery, subject had an active infection or sepsis (treated or untreated) 3. at the time of surgery, subject had presence of malignant tumor, metastatic or neoplastic disease

Keywords: total hip arthroplasty emperion modular stem survivorship
effectiveness of community health workers in hypertension adherence

Conditions: Hypertension

Summary: a community intervention in elderly hypertension patients by community health workers in order to improve patients adherence to treatment


Eligibility criteria:
inclusion criteria: * all patients aged 60 years and older who had been diagnosed with hypertension for more than 3 months at the time of the study were eligible for inclusion. exclusion criteria: * people who are not able to answer interviews or have mental illnesses. * those who, after being interviewed, re-confirmed that they did not have a diagnosis of hypertension from a medical facility.
national prospective infrastructure for renal cell carcinoma (pro-rcc)

Conditions: Renal Cancer; Renal Cell Carcinoma; Renal Cell Cancer Metastatic

Summary: pro-rcc is a nationwide long-term cohort for the collection of real-world clinical data, patient reported outcome measures (proms) and patient reported experience measures (prems) that provides an infrastructure for observational research and (randomized) interventional studies with the twics (trial within cohorts) design.

pro-rcc is designed as a multicenter cohort for all dutch patients with localized rcc or metastatic renal cell carcinoma (mrcc). the clinical data collection is embedded in the framework of the netherlands cancer registry (ncr). next to the standardly available data on rcc, additional clinical data will be collected. the informed consent for pro-rcc covers the online collection of proms and prems, data sharing and data linking with the ncr. proms entail health-related quality of life (hrqol), and optional return to work- questionnaires. prems entail satisfaction with care. both proms and prems are collected through the profiles registry and are accessible for the patient and the treating physician. importantly, participants may also consent to participation in a 'trial within cohort' studies (twic). the twic design provides a method to perform (randomized) studies within the registry.

Eligibility criteria:
inclusion criteria: * newly diagnosed patients with rcc or synchronous metastatic rcc * metachronous metastasized rcc * age \>18 years * capable of understanding dutch language exclusion criteria: * n/a
ultrasound guided axillary access vs standard fluoroscopic technique for cardiac lead implantation: zerofluoroaxi trial

Conditions: Arrhythmias, Cardiac; Venous Puncture; Implantable Defibrillator User; Pacemaker Complication; Vascular Access Complication; Fluoroscopy; Adverse Effect

Summary: single center, randomized trial (1:1 fashion) to asses the safety and the feasibility of the ultrasound guided venous puncture vs standard fluoroscopic technique in patients undergoing pacemaker or implantable cardioverter-defibrillator implantations.

rationale: axillary, cephalic and subclavian venous accesses are commonly used in pacemaker and implantable cardioverter defibrillator implantations. axillary puncture and cephalic vein surgical cutdown are both recommended in international guidelines due to low risk of pneumothorax and chronic lead complications. sometimes cephalic vein is not available. today axillary puncture is performed under fluoroscopic view and some complications still exist with this venous access as pneumothorax and arterial puncture. axillary vein direct visualization can be obtained with standard venography or with ultrasound. with direct visualization and puncture of the axillary vein under ultrasound guidance venography with radiocontrast could be avoided. less radiation exposure for patient and operator and direct visualization of the needle are possible with lower periprocedural complications using ultrasound. despite the great interest for ultrasound guided axillary puncture up today we have few data on its feasibility. our hypothesis is that ultrasound guided axillary access is more safe and more feasible than the standard fluoroscopic technique. we decided to enroll all the patients undergoing standard transvenous pacemaker or cardioverter implantable defibrillator. we randomize the patients with 1:1 fashion to axillary venous access under fluoroscopic guidance or to ultrasound guided axillary venous access. obiectives: to asses safety, feasibility of the ultrasound guided venous puncture. main endpoint: composite of pneumothorax, pocket hematoma, arterial puncture, pocket or device infection, hemothorax at 30 days.

Eligibility criteria:
inclusion criteria: * need of a standard transvenous pacemaker or implantable cardioverter defibrillator implantations * age \> 18 years exclusion criteria: * leadless pacemaker or subcutaneous icd

Keywords: pacemaker icd arrhythmias cardiac implantable electronic device vascular access venous puncture ultrasound fluoroscopy
investigating the impact of the mental health first-aid training course in danish employees

Conditions: Mental Health Impairment

Summary: the purpose of the study is evaluate the effect of the mental health first-aid training course on a danish population of employees.

background: studies show a high and growing prevalence of mental disorders in the population worldwide. 25 % of the general population in europe will during their lifetime experience symptoms related to a mental disorder. the mental health first aid concept (mhfa) was founded in 2000 in australia by kitchener and jorm, in order to provide the population with mental health first aid skills. objective: the aim of the concept is, through an educational intervention (course), to increase confidence in how to help people suffering from mental health problems. further, secondary aims are to increase the mental health literacy of the public by increasing knowledge, reduce stigma and initiate more supportive actions leading towards professional help. an investigation of the effect of mhfa offered a danish population is needed. design and methods: the design is a randomized controlled superiority trial, in which 500 participants will be allocated to either the intervention group or the control group. the control group will attend the course six months later, hence waiting list design. from fall 2013 to spring 2014 participants will be educated in mental health first-aid following a manualized, two days mhfa course. all the participants will answer a questionnaire at base-line and at 6 months follow-up. the questionnaire is a back-translation of the questionnaire used in australian trials. the trial will be complemented by a qualitative study, in which focus groups will be carried out. outcome: the primary outcome measure is increased confidence in help-giving behavior among the participants. secondary outcome will be increased knowledge of and improved positive attitudes towards people suffering from a mental health problem.

Eligibility criteria:
inclusion criteria: people, who in their line of work are in contact with many different individuals exclusion criteria: none

Keywords: mental illness training support mental health
virtual reality-based exercise training in radiotherapy period after breast cancer surgery

Conditions: Breast Cancer; Exercise; Upper Extremity Dysfunction

Summary: the main purpose of this study is to compare two different exercise approaches during the radiotherapy period in patients who have undergone breast cancer surgery.

exercise therapies are effective methods in the treatment of complications after breast cancer surgery. the study aims to compare exercise practices with virtual reality-based exercise training during radiotherapy period after breast cancer surgery. patients were randomly divided into 3 groups as virtual reality group, exercise group, and control group, considering the order of arrival at the clinic and the type of surgery (mastectomy and breast-conserving surgery). patients in virtual reality group received virtual reality-based exercise training using microsoft xbox 360 kinect (redmond, wa). patients in exercise group received an exercise program including range of motion, posture, stretching and breathing exercises. both exercise groups participated in the exercise program for 30- 40 minutes, 3 days a week, as long as radiotherapy continued (5-6 weeks). patients in the control group did not receive any exercise intervention as is done in the current practice. assessment methods were applied at the beginning and at the end of the radiotherapy for all groups. shoulder range of motion was measured using universal goniometer. hand grip strength was measured using jamar hand dynamometer. shoulder proprioception was measured using cybex (lumex,ny,usa) isokinetic dynamometer. upper extremity functional status, kinesiophobia, anxiety and depression level, fatigue and quality of life were evaluated with various questionnaires.

Eligibility criteria:
inclusion criteria: * being over 18 years old * being literate * having a diagnosis of unilateral breast cancer * having undergone surgery for breast cancer * radiotherapy will be applied for breast cancer treatment. exclusion criteria: * metastasis * have an active infection * having a cardiac or neurological disease that would prevent participation in the study * having uncontrolled hypertension * having an orthopedic disorder that prevents exercise * having sensory or cognitive impairments that interfere with communication

Keywords: virtual reality exercises breast cancer radiotherapy
ramelteon in the treatment of sleep and mood in patients with seasonal affective disorder

Conditions: Seasonal Affective Disorder

Summary: the purpose of this study is to determine whether treating sleep difficulties in patients with seasonal affective disorder also improves their depressive symptoms.

seasonal affective disorder(sad) is a type of depression in which a patient's depressive symptoms worsen in the winter. these patients' depressive symptoms often lessen in the spring and summer months. much of the focus of the treatment of sad (light therapy and melatonin) has involved the brain's suprachiasmatic nucleus(scn), as it is hypothesized that one potential reason for sad is a desynchronized scn. ramelteon offers a new and more pharmacologically exact mechanism to re-synchronize the scn. the administration of ramelteon for this patient population may improve sleep, and in addition, do so in a manner that may also reduce their seasonal affective depressive symptoms. patients eligible for enrollment will be administered either ramelteon or placebo and return to the study office for 4 monthly visits over the winter months, to evaluate the effects of ramelteon versus placebo on sleep and mood.

Eligibility criteria:
inclusion criteria: * male or female age 18-65 yrs. * a diagnosis of seasonal affective disorder * a pittsburgh sleep quality index \>5 * english speaking * be able to sign informed consent exclusion criteria: * active substance abuse * current psychotic symptoms * severe personality disorders * primary sleep disorders * severe chronic obstructive pulmonary disease (copd) * prescription fluvoxamine(luvox) use

Keywords: seasonal affective disorder ramelteon psychiatry randomized controlled trial hamilton depression rating scale- sad version circadian rhythm
rates of gastric ulcer by endoscopy in knee osteoarthritis patients receiving lt-ns001 versus naprosyn®

Conditions: Osteoarthritis

Summary: lt-ns001 is a prodrug of naproxen, which is inactive as a cox inhibitor while intact and is rapidly metabolized to naproxen once absorbed. this trial will compare the rate of gastric ulcer by endoscopy over three months in patients with knee osteoarthritis, with patients receiving either lt-ns001 at a dose which provides comparable dose levels of naproxen, or naprosyn® 500mg (an approved treatment for oa).

this is a double-blind, double-dummy, active-comparator study of lt-ns001 versus naprosyn® for 12 weeks in patients aged 45-80 with osteoarthritis of the knee who are candidates for ongoing nsaid therapy. the percentage of patients with a gastric ulcer by endoscopy (egd) at week 12 will be compared. egd is performed at screening and months 1, 2, and 3. secondary objectives include assessment of pain in the affected knee by womac questionnaire to demonstrate non-inferior pain control using lt-ns001 as compared to naprosyn®. information about gastrointestinal pain and tolerability will be collected. the length of the study is up to 19 weeks with a 2-3 week screening period, a 12 week treatment period and a 4 week post treatment monitoring period.

Eligibility criteria:
inclusion criteria: * osteoarthritis of knee * appropriate candidate for chronic nsaid therapy due to moderate or severe pain on most days in the 28 days before screening for study. exclusion criteria: * pregnant/nursing women * history of gi bleeding, perforation or obstruction * a documented symptomatic gi ulcer during past 5 years * presence of gi ulcer or more than 2 erosions on screening endoscopy * allergy to naproxen (or naproxen intolerance), acetylsalicylic acid, or other nsaid drug

Keywords: lt-ns001 gastric ulcers nsaid osteoarthritis naproxen
optic nerve sheath measurement and angiogenic factors in patients with pre-eclampsia.

Conditions: Pre-Eclampsia

Summary: hypertensive disorders of pregnancy (hpt) are an important cause of maternal-feto-neonatal morbidity and mortality, being one of the three leading causes of maternal death in our country and in developing countries. the only cure for the is termination of pregnancy, which ends up being a decision in which gestational age and maternal risks must be balanced. angiogenic factors have come to occupy an indispensable place in the arsenal of tools that can be used to separate the patient with a high likelihood of complications from those in whom prolongation of pregnancy could represent an important neonatal benefit. refining the diagnostic capability of this test would further improve maternal-fetal outcomes and the use of optic nerve sheath diameter (onsd) measurement could make the difference. the purpose of the present study is to correlate the measurement of onsd with serum angiogenic factor (af) values in patients with pre-eclampsia and to determine its predictive ability for adverse perinatal outcomes.


Eligibility criteria:
inclusion criteria: * pregnant women between 24 and 40 weeks of gestation. exclusion criteria: * multiple gestation * maternal vasculitis * previous cesarean section (3 or more) * brain or eye tumors * neurological conditions * chronic renal disease * purpura * heart disease

Keywords: angiogenic factors optic nerve sheath diameter pre-eclampsia
fluciclovine f18 pet/ct in identifying the origin of head and neck squamous cell carcinoma in patients with metastatic cervical nodal disease

Conditions: Metastatic Head and Neck Squamous Cell Carcinoma; Metastatic Squamous Cell Carcinoma in Cervical Lymph Node

Summary: this early phase i trial studies how well fluciclovine f18 positron emission tomography (pet)/computed tomography (ct) works in identifying the origin of head and neck squamous cell carcinoma in patients with cancer that has spread to the cervical lymph nodes. fluciclovine f18 during a pet/ct scan may work better in helping doctors learn where the cancer started (called the site of origin) and directing treatment planning compared to standard fludeoxyglucose f-18 (fdg) pet-ct scans.

primary objectives: i. to estimate positive predictive value with a corresponding 95% confidence interval for fluciclovine f18 (18f fluciclovine) positron emission tomography computed tomography (pet ct) to detect a primary site of disease in patients presenting with cervical metastatic nodal disease but a head and neck primary site not apparent on ct of the neck with contrast (contrast enhanced-computed tomography, ce-ct). secondary objectives: i. to estimate positive predictive value with a corresponding 95% confidence interval for fludeoxyglucose f-18 (18f fdg) pet ct in the detection of a primary site of disease in patients presenting with cervical metastatic nodal disease but a head and neck primary site not apparent on ct of the neck with contrast. exploratory objectives: i. to compare the lesion to background (l/b) ratios for nodal metastatic disease between 18f fluciclovine pet ct and 18f fdg pet ct. ii. to estimate the sensitivity of 18f fluciclovine pet ct and 18f fdg pet ct to detect nodal disease. iii. to evaluate for any trends in findings on 18f fluciclovine pet ct and human papillomavirus (hpv) status. outline: patients receive fluciclovine f18 intravenously (iv) and undergo pet/ct scan over 20-30 minutes.

Eligibility criteria:
inclusion criteria: * adults with biopsy proven metastatic cervical nodal squamous cell carcinoma * ct of the neck with contrast that does not confidently identify a primary oropharyngeal site of disease * planned standard of care 18f-fdg pet ct examination * planned standard of care exam under anesthesia with oropharyngeal surgical biopsy exclusion criteria: * pregnant women * known allergy to fdg, fluciclovine, or iodine-based contrast agents * severe renal dysfunction (glomerular filtrate rate \[within 30 days\] less than 30) * inability to tolerate lying supine, relatively motionless for up to 1 hour