Kornimate/medical-research-clean huggingface dataset:
blood pressure monitoring in hypertensive populations: device testing, feasibility, acceptability

Conditions: Hypertension

Summary: the goal of this study is to test a novel cuffless blood pressure (bp) monitoring device (bio-z) within adults with hypertension (high blood pressure) for clinical use. the main questions it aims to answer are: * to validate a novel cuffless blood pressure (bp) monitoring device (bio-z) within adults with hypertension (high blood pressure) * to assess bp monitoring accuracy, against reference bp measurements captured by a finapres nova® continuous bp monitoring device in correspondence with blood pressure monitoring devices standards. researchers will test the device against the finapres nova® blood pressure monitoring device.

the purpose of this study is to evaluate a novel cuffless blood pressure monitoring device for clinical use. this device is a cuffless blood pressure watch worn on the wrist called bio-z. the device will be tested against the finapres nova® which is fda-approved to capture continuous bp measurements. the participant will only need wear a wristband, potentially eliminating the need to perform cuff-based readings. during the 2-hour visit, research coordinators will conduct exercises to change bp and compare the values gathered by the bio-z watch with the finapres nova® device and a standard blood pressure cuff. the investigators will also test whether the bio-z can capture blood pressures that are in the low and high range, and whether motion affects the quality of measurement. the ultimate goal is to develop a device that passively collects blood pressure continuously, which is more convenient than a standard blood pressure cuff. 15 participants will have the option to complete study procedures twice more, spaced one week apart, for a total of three weeks of participation.

Eligibility criteria:
inclusion criteria: * hypertensive volunteers who have a history of hypertension or a bp \>140/90 mmhg on two consecutive ambulatory visits within the last year. * able to read, understand, and provide written informed consent in english * willing and able to participate in the study procedures as described in the consent form * able to communicate effectively with and follow instructions from the study staff exclusion criteria: * persons with pacemakers and/or a non-sinus rhythm (a-fib) * persons who are taking 4 or more anti-hypertensive medications * persons on dialysis * persons who are unstable * persons with tremors * persons with known peripheral artery disease * persons with more than 10 mmhg differential blood pressure between right and left arm * persons taking medications that might affect the hypothalamic-pituitary-adrenal axis * the investigators will exclude persons who are known to be pregnant after 20 weeks because of physiological changes in bp after 20 weeks of pregnancy; and will refer to electronic health record data to determine pregnancy status at the time of screening. the investigators will not exclude participants of childbearing age or who become pregnant during the study since there are no risk of the devices to a pregnant person.
comparison of bipolar hemiarthroplasty and total hip arthroplasty with dual mobility cup

Conditions: Dislocations

Summary: this study is conducted with the aim to compare the functional outcome, rate of dislocation, complications and mortality after treatment of displaced neck of femur fracture with bipolar hemiarthroplasty or total hip arthroplasty with dual mobility cuff.

this study is conducted with the aim to compare the functional outcome, rate of dislocation, complications and mortality after treatment of displaced neck of femur fracture with bipolar hemiarthroplasty or total hip arthroplasty with dual mobility cuff. this study is conducted with the aim to compare the functional outcome, rate of dislocation, complications and mortality after treatment of displaced neck of femur fracture with bipolar hemiarthroplasty or total hip arthroplasty with dual mobility cuff. a retrospective cohort study will be conducted at our tertiary care level 1 trauma center .erc approval wwill taken from ethical review committee of the hospital. patients of age group more than 60 year who underwent hip arthroplasty (bipolar hemiarthroplasty or tha with dual mobility implant) between 2015 and 2017 for displaced neck of femur fracture with a complete follow up for one year were included. both groups will be assessed for postoperative complications including surgical complications (dislocation, periprosthetic fracture and surgical site infection), one year mortality and functional outcome via harris hip score at the latest follow up. data will be analyzed using spss version 20.chi-sqaure test was used to compare categorical variables whereas independent sample t-test was used to compare continuous variables. p-value of \<0.05 was considered significant

Eligibility criteria:
inclusion criteria: * . patients of age group more than 60 year who underwent hip arthroplasty (bipolar hemiarthroplasty or tha with dual mobility implant) between 2015 and 2017 for displaced neck of femur fracture with a complete follow up for one year exclusion criteria: * patient who underwent hip arthroplasty for other indications, patients younger than 60 years patient with pathological fractures, patient with missing records and patients lost to follow up

Keywords: dual mobility cup total hip repcament bipolar hemiarthroplasty dislocation
special access program imvamune®

Conditions: Vaccination

Summary: prophylactic smallpox vaccination for personnel actively working with or in the vicinity of replicating vaccinia virus


Eligibility criteria:
inclusion criteria: * male and female subjects, aged 18-65 years, who will work with or in the vicinity of a replicating vaccinia virus and who volunteer for the program. subjects may be vaccinia-naïve or vaccinia-experienced. * women of child-bearing potential (wocbp) must have a negative urine pregnancy test within 48 hours prior to vaccination. * wocbp must have used an acceptable method of contraception for at least 30 days prior to the first vaccination and must agree to use an acceptable method of contraception during the vaccination period until at least 28 days after the last vaccination. a woman is considered of child-bearing potential unless post-menopausal or surgically sterilized. (acceptable contraception methods are restricted to barrier contraceptives which include food and drug administration (fda)-approved spermicides, intrauterine contraceptive devices, or licensed hormonal products.) * read, signed and dated informed consent form. exclusion criteria: * pregnant or breast-feeding women. * uncontrolled serious infection i.e., not responding to antimicrobial therapy. * history of or active autoimmune disease. persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. * known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; uncontrolled diabetes mellitus; moderate to severe kidney impairment or post organ transplant subjects. * history of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. * history of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor. * history of allergies or reactions to eggs, egg products, or gentamycin. * having received any vaccinations or planned vaccinations with a live vaccine within 28 days or a killed vaccine within 14 days prior to or after imvamune®vaccination. * chronic administration (defined as more than 6 days) of systemic corticosteroids within 30 days of the first planned vaccination. * use of any investigational or non-registered drug or vaccine other than imvamune® within 30 days preceding the first vaccine dose.
craniectomy protocol

Conditions: Ischemic Stroke; Decompressive Craniectomy

Summary: the objective of this protocol is to evaluate the quality of life and functional disability in the long term (2 years after craniectomy) in subject's victims of malignant sylvien stroke who received a decompressive craniotomy in the acute phase. patients who have given their consent to be evaluated at least two years after their stroke and their operation in a single visit by clinical examination and procurement of standardized scales. will be measured the quality of life through scale sis3.0, residual disability by the rankin scale. the quality of life of the carer will be assessed through scales and zarit carer version of sis3.0. the existence of predictive parameters of long-term evolution will be searched in determining the existence of a correlation between demographic data and baseline characteristics of the stroke on and the evolution of the quality of life.


Eligibility criteria:
inclusion criteria: * age\> = 18 years * having presented an ischemic stroke involving the sylvian area * having received decompressive craniectomy in acute ischemic stroke * time between stroke and the inclusion of at least 24 months * signed informed consent * patient affiliated to a social security system exclusion criteria: * patients with a rankin score before stroke than or equal to 3 * stroke in multiple territories (contralateral carotid and / or vertebrobasilar) associated with stroke in the acute phase describing which in the opinion of the investigator significantly influence the long-term functional prognosis * cognitive deterioration or severe aphasia making it impossible to fill out questionnaires * minors * major under curators
artesunate pessaries (vaginal inserts) for cervical precancer in kenya

Conditions: Cervix Cancer; Cervix Neoplasm; Precancerous Conditions; Cervical Precancer

Summary: to investigate the use of self-administered artesunate vaginal pessaries as treatment for cervical precancer in low and middle-income countries (lmic). the central hypothesis of this study is that self-administered intravaginal artesunate will be safe, and result in a clinical response among both hiv-positive and hiv-negative women with cervical precancer in lmics.

despite being preventable, cancer of the cervix is a leading cause of cancer death in kenya and other low- and middle-income countries (lmic). cervical cancer can be prevented if early changes in the cervix, called cervical precancer, are detected through screening, and adequately treated. cervical precancer treatment includes a surgical procedure called loop electrosurgical excision procedure (leep), which removed the involved area of the cervix. in countries like kenya, this leep procedure is only available in referral hospitals which have trained consultants, and hence is difficult to access for most women who live in rural areas and away from tertiary facilities. additionally, the leep procedure also increases the chance of a woman not being able to carry a pregnancy to full term, because the cervix is shorter after the procedure. for these reasons, alternative treatments, including self-administered treatments such as artesunate are being investigated as alternative cervical precancer treatment that can be self-administered.

Eligibility criteria:
inclusion criteria: 1. cervical lesions referred for excision with cin2/3 diagnosis on biopsy 2. weight ≥50 kg 3. agreement to use contraception (barriers or hormonal) through week 24 of the study if of childbearing age. 4. ability and willingness to provide informed consent. exclusion criteria: 1. current pregnancy or breastfeeding status. 2. current or past history of invasive cervical cancer. 3. history of total hysterectomy. 4. cd4 count less than 200 cells/mm3. 5. presence of adenocarcinoma in situ on cervical biopsy 6. currently receiving systemic chemotherapy or radiation therapy for another cancer 7. current use of systemic immunosuppressants or steroids (\>10 mg of prednisone or equivalent) 8. have a medical comorbidity that in the opinion of the investigator would interfere with study participation. 9. prior chemotherapy within 1 month prior to day 1 of study treatment 10. male at birth

Keywords: vaginal pessaries artesunate
wellnara post-marketing surveillance in japan

Conditions: Osteoporosis, Postmenopausal

Summary: this study is a regulatory post marketing surveillance in japan, and it is a local prospective and observational study of patients who have received wellnara for postmenopausal osteoporosis. the objective of this study is to assess safety and efficacy of using wellnara in clinical practice. a total 400 patients will be recruited and followed 3 years since starting wellnara administration.


Eligibility criteria:
inclusion criteria: * patients who received wellnara for postmenopausal osteoporosis exclusion criteria: * patients who are contraindicated based on the product label

Keywords: wellnara postmenopausal osteoporosis
a study of soticlestat as an add-on therapy in children and adults with dravet syndrome or lennox-gastaut syndrome

Conditions: Dravet Syndrome (DS); Lennox Gastaut Syndrome (LGS)

Summary: the main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of seizures in children and adults with dravet syndrome (ds) or lennox-gastaut syndrome (lgs). participants will receive their standard anti-seizure therapy, plus tablets of soticlestat. there will be scheduled visits and follow-up phone calls throughout the study.

the drug being tested in this study is called soticlestat (tak-935). soticlestat administered long-term in pediatric and adult participants who participated in an antecedent soticlestat phase 3 clinical study will be assessed for additional safety and tolerability data along with efficacy analysis, as well as palatability and acceptability of soticlestat in the pediatric population. the study will enroll approximately 400 participants. all participants will receive soticlestat based on their weight in the 2-week titration period (for participants who roll over from an antecedent double-blind study). following the titration period, participants will continue to receive the same dose in the maintenance period. at the end of maintenance period, the dose will be down-tapered (unless already at the lowest dose) and then stopped. participants not tolerating minimum dose of 100 mg twice a day (bid) will be discontinued from the study. this multi-center trial will be conducted worldwide. the overall time to participate in the study will be approximately 4 years, or until the study is stopped at the discretion of the sponsor, or the product is approved and launched. participants who discontinue study drug treatment before the completion of the study, will continue to be followed per protocol and maintain a daily seizure diary until the final follow-up phone call.

Eligibility criteria:
inclusion criteria: 1. participant must have: * been previously enrolled in a phase 3 soticlestat clinical study. exclusion criteria: 1. unstable, clinically significant neurologic (other than the disease being studied), psychiatric, cardiovascular, ophthalmologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, endocrine disease, malignancy including progressive tumors, or other abnormality that may impact the ability to participate in the study or that may potentially confound the study results. it is the responsibility of the investigator to assess the clinical significance; however, consultation with the medical monitor may be warranted. 2. abnormal and clinically significant ecg abnormality at visit 1 including qt interval with fridericia correction method (qtcf) \>450 milliseconds (ms) confirmed with a repeat ecg using manual measurement of qtcf. 3. participant is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. participants who have positive answers on item numbers 4 or 5 on the cssrs before dosing are excluded. this scale will only be administered to participants aged ≥6 years.

Keywords: drug therapy
clinical performance of qiastat-dx® gastrointestinal panel 2

Conditions: Gastrointestinal Infection

Summary: performance evaluation of qiastat-dx® gi2 panel using the qiastat-dx® analyzer to demonstrate that the qiastat-dx® gi2 panel achieves its intended performance during normal conditions of use by the intended user in the intended environment

the objective of the study is to demonstrate that the qiastat-dx® gastrointestinal panel 2 achieves its intended performance during normal conditions of use by the intended user in the intended environment. the primary objective is to evaluate the performance of qiastat-dx® gi2 panel in comparison with the results obtained from the reference methods. the secondary objective of the study is to evaluate the safety of qiastat-dx® gi2 panel with respect to users/operators. the primary study endpoint will be the results for each analyte obtained from testing prospective and retrospective specimens with qiastat-dx® gi2 panel and reference method(s). positive percent agreement (ppa) and negative percent agreement (npa) will be determined

Eligibility criteria:
inclusion criteria: 1. stool specimen must have been collected from subjects/patients which meet the institute's criteria for a suspected enteric pathogen, such as individuals presenting with symptoms of gastrointestinal infection; 2. stool specimen will be residual and obtained for completion of routine gastrointestinal testing; 3. specimen for testing will consist of stool specimens preserved in cary- blair medium following the manufacturer's instructions for use; 4. fresh, unpreserved stool must be transferred to cary-blair as soon as possible after specimen collection; 5. when fresh stool is transferred into the cary-blair container, the maximum fill line of the container should not be exceeded; 6. there is an adequate residual volume (minimum 1.0 ml) of cary- blair preserved stool specimens; 7. cary- blair preserved stool specimens should represent a homogenous suspension (easily vortexed); 8. cary- blair preserved stool specimens have been stored at the following conditions prior testing: * up to 4 days at room temperature (15 to 25˚c). * up to 4 days at 2 to 8˚c (refrigerated); 9. samples should be tested on the qiastat-dx® system and the reference method filmarray within 3 hours of each other. exclusion criteria: 1. whole stool specimen that had been frozen; 2. specimen that had been centrifuged; 3. lack of clear subject identification or label on residual stool specimen; 4. obvious physical damage of residual stool specimen; 5. repeated specimens from the same subject; 6. specimens in preservative collection media other than cary-blair; 7. specimen containing formalin or any other fixative; 8. rectal swab specimens 9. specimens not collected according to manufacturer's instructions (under-filled or overfilled specimens); 10. specimen contaminated with urine or water; 11. leaking container.

Keywords: gastrointestinal infection qiastat-dx clinical performance study
paracetamol treatment of the borderline significant pda

Conditions: Patent Ductus Arteriosus

Summary: the therapeutic approach to the patent ductus arteriosus (pda) in the premature neonate remains controversial. currently it is generally accepted to treat only hemodynamically significant pdas. the current investigation aims to study the effect of treatment on pdas of borderline significance via a prospective, randomized controlled trial of paracetamol in this group.

in the neonatal intensive care unit of the shaare zedek medical center, preterm babies \<30 wks. ga, are studied echocardiographically on day of life 3-4. pending parental informed consent, those diagnosed with a pda of borderline significance will be randomized to receive either paracetamol or placebo for three days, followed by a repeat echocardiogram. if the pda remains of borderline significance, the treatment will be continued for an additional 4 days (1 week total). paracetamol levels and liver functions will be assessed after the third day. babies will be followed until discharge for subsequent pda pathology; respiratory distress and chronic lung disease \[cld\]; necrotizing enterocolitis \[nec\]; retinopathy of prematurity \[rop\]. the investigators' primary goal is to demonstrate a decrease in the composite outcome of death or severe morbidity chronic lung disease \[cld\], as shown by decreased time on supplemental oxygen and assisted ventilation. secondary goals: * to demonstrate a decrease in subsequently diagnosed hs pda, including * decrease in the need for subsequent therapy for pda closure * decrease in surgical pda ligations * to demonstrate a decrease in necrotizing enterocolitis (nec) and/or rop with treatment. * to demonstrate no adverse effect on blood flow in anterior cerebral, superior mesenteric and renal arteries.

Eligibility criteria:
inclusion criteria: * preterm neonates \< 30 weeks' gestational age pda of borderline significance exclusion criteria: * infants not deemed likely to survive more than one week infants with congenital heart malformations infants with pulmonary hypertension and right to left ductal shunting
anterior vaginal wall repair with mesh in combination with tvt-o to reduce urinary stress incontinence

Conditions: Pelvic Organ Prolapse

Summary: urinary stress incontinence is defined as leakage of urine during stress. urinary stress incontinence is a health problem with social, economic and psychological consequences. the appearance of urinary stress incontinence post vaginal wall prolapse repair is a known phenomena. part of the cases relate to pre-surgical occult urinary stress incontinence which has been asymptomatic, and part of the cases relate to de-novo urinary stress incontinence post surgery. latest studies have demonstrated 11-22% rate of post surgical urinary stress incontinence. the aim of this study is to examine the efficacy of transobturator tension free vaginal tape (tvt-o) among women who intend to undergo vaginal wall repair by a vaginal approach.

urinary stress incontinence is defined as leakage of urine during stress (cough, lough, sneezing, coitus, heavy lifting, physical activity). urinary stress incontinence is a health problem with social, economic and psychological consequences. the appearance of urinary stress incontinence post vaginal wall prolapse repair is a known phenomena. part of the cases relate to pre-surgical occult urinary stress incontinence which has been asymptomatic, and part of the cases relate to de-novo urinary stress incontinence post surgery. latest studies have demonstrated 11-22% rate of post surgical urinary stress incontinence. the care study has examined the efficacy of preventive burch retropubic urethropexy among women who underwent abdominal sacrocolpopexy. according to this study, the burch procedure reduced the rate of post surgery urinary stress incontinence. the authors recommend to offer those women the preventive surgery. those results cannot be relied on when considering vaginal wall repair by the vaginal approach. the aim of this study is to examine the efficacy of transobturator tension free vaginal tape (tvt-o) among women who intend to undergo vaginal wall repair by a vaginal approach.

Eligibility criteria:
inclusion criteria: * women with vaginal wall prolapse grade 2 and more * no contraindication to vaginal wall repair or tvt-o * no stress incontinence exclusion criteria: * urinary tract malformations * past urinary stress incontinence surgical procedure * udi - question 17 or 18 - positive answer * occult urinary stress incontinence

Keywords: preventive tvt-o stress incontinence