Kornimate/medical-research-clean huggingface dataset:
safety and tolerability of a single intra-anal dose of nrl001 in healthy volunteers

Conditions: Fecal Incontinence

Summary: this study is conducted to explore the safety and tolerability and plasma pharmacokinetics of nrl001 after single intra-anal dose of 1ml cream at increasing concentrations.


Eligibility criteria:
inclusion criteria: in.1) sex: male and female (non-child-bearing potential or using medically adequate contraception in.2) race: caucasian in.3) bw: 50 - 100 kg in.4) bmi: 20 - 28 kg.m-2 in.5) age: 21 - 50 years in.6) type: healthy on the basis of specified criteria evaluated at the screening visit in.7) willing and able to provide informed consent exclusion criteria: general ex.1) previous participation in the trial ex.2) participant in any other trial during the last 90 days ex.3) donation of blood during the last 60 days or a history of blood loss exceeding 300 ml within the last 3 months ex.4) history of any clinically relevant allergy (including hypersensitivity to the trial medications) ex.5) presence of acute or chronic infection ex.6) presence or history of any relevant co-morbidity ex.7) resting systolic blood pressure \> 140 or \ 95 or \< 50 mmhg ex.8) clinically relevant ecg-abnormalities, prolonged qtc with \> 450 msec in males and \> 460 msec in females in particular ex.9) presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes ex.10) positive serology for hbsag, anti hbc and anti hcv ex.11) positive hiv test ex.12) positive alcohol or urine drug test on recruitment (and upon admission) ex.13) history of alcohol and/or drug abuse and/or daily use of \> 30 gr alcohol ex.14) smoking more than 15 cigarettes/day or equivalent of other tobacco products ex.15) use of prohibited medication ex.16) suspicion or evidence that the subject is not trustworthy and reliable ex.17) suspicion or evidence that the subject is not able to make a free consent or to understand the information in this regard general - all females ex.18) positive pregnancy test ex.19) lactating ex.20) not using appropriate contraception in pre-menopausal women (note: under the conditions of the present study, women using hormonal contraceptives will be informed that this method is not sufficient during the study and that further i.e. mechanical methods \[condom, diaphragm with spermicidal gel\] should be used in addition).
long-term outcomes of robot-assisted radical cystectomy: a real-world study

Conditions: Bladder Cancer; Robot-assisted Radical Cystectomy

Summary: a multicenter, retrospective research was conducted. patients who underwent robot-assisted radical cystectomy (rarc) from for bladder cancer in 32 institutions in china were enrolled in this study. baseline condition, perioperative, pathological, and survival outcome were collected. the study was aimed to report the real-world condition of rarc in china, and evaluate its effectiveness.


Eligibility criteria:
inclusion criteria: * \>18 years old; clinical stage ta-t4a/n0-3/m0. exclusion criteria: * severe cardiovascular disease; history of previous major abdominopelvic surgery; patients with distant metastases; medical history of malignancy in other organs.
study to test the effect of cdp870 in the treatment of crohn's disease over 26 weeks, comparing cdp870 to a dummy drug (placebo), following 3 doses of active drug (cdp870).

Conditions: Crohn's Disease

Summary: a 26 week maintenance study of cdp870 in crohn's disease


Eligibility criteria:
inclusion criteria: * definitive diagnosis of crohn's disease confirmed (at least 3 months prior to study entry) either by radiological, endoscopic or histological evidence, affecting the terminal ileum (l1), colon (l2) or ileocolon (l3)\*. \* vienna classification (1998) * active crohn's disease (≥ 220 and ≤ 450) scored over the 7 days prior to the first dose of study drug. * patients aged 18 years or above at screening. exclusion criteria: * crohn's disease related * fistula abscess present at screening. * stricturing type disease with symptoms or signs of non-inflammatory mechanical obstruction or bowel perforation in last 3 months. * short bowel syndrome. * functional colostomy or ileostomy (note: patients who have had a temporary stoma in the past, which has been reversed, are eligible to enter the study). * positive stool laboratory results for enteric pathogens.

Keywords: crohn's disease, cdp870, cdai, clinical response, remission, certolizumab pegol, cimzia
clinical investigation of the freedom solo stentless heart valve

Conditions: Heart Valve Diseases

Summary: this is a trial to demonstrate the safety and effectiveness of the freedom solo heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

freedom solo study is a prospective, non-randomized, multicenter trial on the freedom solovalve implanted in patients requiring aortic valve replacement. the study was conducted at 18 centers in europe. the study was based on single sample hypothesis testing that allows comparison of observed morbid event rates to objective performance criteria (opcs). based on the guidelines established by the u.s. food and drug administration (fda), the minimum sample size for this study was 800 valve-years, which is the minimum amount of data needed to test against the opc of 1.2 %/patient-year.

Eligibility criteria:
inclusion criteria: * the patient is male or female 18 years old or older. * the patient is willing to sign the informed consent. * the patient which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement. * any patient amenable to aortic valve replacement with biological prosthesis should be enrolled in the study, even in conjunction with valve repair, coronary artery bypass grafting and other procedures. * the patient is located in a geographic location that will enable the subject to return to the study site for all follow-up examinations (i.e. geographically stable). * patient will be available to the investigator(s) for postoperative follow-up beyond one year. exclusion criteria: * the patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position. * the patient requires a double or triple valve replacement (a valve repair is not considered an exclusion criterion). * the patient has a previously implanted solo valve, within the clinical study, that requires replacement. * the patient has active endocarditis. * the patient is or will be participating in a concomitant research study of an investigational product. * the patient is a minor, intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent. * the patient has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the patient. * the patient is pregnant or lactating. * patients with congenital bicuspid aortic valve. * patients are known to be noncompliant or are unlikely to complete the study.

Keywords: heart diseases. aortic valve diseases. aortic valve insufficiency. aortic valve stenosis.
teen asthma project

Conditions: Asthma

Summary: aims of this study are: 1. to determine the feasibility of implementing the intervention using a peer-assisted asthma day camp for adolescents with asthma. 2. to determine patterns of change in knowledge, attitudes toward asthma, self-efficacy, perception of barriers, and self-management behaviors, asthma control and quality of life over time among peer leaders. 3. to test the following hypothesis: * adolescents participating in a peer-assisted asthma camp program will report improved knowledge, attitudes toward asthma, self-efficacy, and self-management behaviors, decreased perception of barriers, and increased asthma control and quality of life at 3-, 6- and 9-months post-intervention compared with the adult-led camp group. 4. to examine the moderating effect of personal factors (e.g., age, sex, socioeconomic status, race, illness status, family support) on intervention outcomes such as self-management behaviors, asthma control and quality of life in adolescents with asthma. 5. to examine the effect of the peer-assisted camp program on self-reported health care utilization including emergency department visits, days of hospitalization, outpatient visits by comparing between baseline and 9-months post-camp data and between the peer-led camp and the adult-camp programs.


Eligibility criteria:
inclusion criteria: 1. age between 13-18 years 2. mild, moderate or severe persistent asthma specified by the nhlbi asthma guidelines 3. asthma diagnosis \> 1 year 4. no other major chronic/emotional health concerns 5. ability to understand spoken and written english. participants were recruited from the communities through flyers, newspaper ads, and referrals from clinics and schools. eligibility criteria for peer leaders included: 1. age between 16-20 years 2. nomination from school teachers/nurses or health care providers 3. average grade point b or above in the past school year 4. fulfillment of eligibility criteria (2)-(5) prescribed for adolescent participants. exclusion criteria: * learning disabilities based on reports from parents, teachers or clinicians

Keywords: adolescents peer leader program asthma camp asthma control quality of life self-efficacy knowledge attitudes barrier perceptions
lesinurad/allopurinol 200/300 fixed-dose combination (fdc) tablets bioequivalence.

Conditions: Gout

Summary: to assess the bioequivalence between lesinurad/allopurinol 200/300 fdc tablets and coadministered lesinurad and allopurinol tablets in the fasted state based on the pharmacokinetic (pk) evaluation of lesinurad and allopurinol in healthy adult subjects.


Eligibility criteria:
inclusion criteria: * body mass index ranging between 18.5 kg/m2 and 30 kg/m2. * screening serum urate level is ≤ 7.0 mg/dl. exclusion criteria: * asian subject who has a positive test for the hla-b\*5801 allele. * history or current diagnosis of kidney stones. * estimated creatinine clearance, as determined at screening, of ≤ 80 ml/min calculated by the cockcroft-gault formula using ideal body weight. * undergone major surgery within 3 months prior to screening. * donated blood within 4 weeks prior to day 1 or experienced an event (other than blood donation) of significant blood loss (\> 450 ml) within 12 weeks prior to day 1 or has given a plasma donation within 4 weeks prior to day 1. * inadequate venous access or unsuitable veins for repeated venipuncture. * received any strong or moderate enzyme-inducing drug or product within 2 months prior to screening.
duloxetine versus placebo in the treatment of fms

Conditions: Fibromyalgia

Summary: to test the hypothesis that the efficacy and safety of duloxetine has beneficial effects of the reduction of pain severity as measured by the average pain item of the bpi and the pgi-i in patients with fibromyalgia syndrome.


Eligibility criteria:
inclusion criteria: * meet criteria from primary fms as defined by the acr: widespread aching pain in all four quadrants of the body and axial skeleton and greater than or equal to 11 of 18 tender points under digital palpation examination * measure average pain item of the bpi at visits 1 and 2 exclusion criteria: * have pain symptoms related to traumatic injury, structural rheumatic disease, or regional rheumatic disease that will interfere with interpretation of outcome measures * have regional pain syndrome, multiple surgeries or failed back syndrome * have confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (i.e. systemic lupus erythematosus) * have current primary axis i diagnosis other than major depressive disorder (mdd), including a current diagnosis of dysthymia
treatment for sexual dysfunction in women with spinal cord injury

Conditions: Spinal Cord Injuries

Summary: women with spinal cord injury frequently experience sexual dysfunction such as disturbances during arousal and an increased time to orgasm. however, little evidence has been found on its therapeutic approach and low adherence. to verify the effectiveness of two interventions: the application of genital vibration and transcutaneous stimulation of the tibial nerve. this is a randomized clinical trial. 54 women will be recruited who suffer from sexual dysfunction.

the allocation will be randomly assign to the three groups: an intervention group 1 transcutaneous electrostimulation of tibial nerve (n = 18), an intervention group 2 genital vibration (n = "18) and a control group (n = 18). the treatment time will be 12 weeks. treatment adherence, as well as treatment effectiveness, will be evaluated through the female sexual function index, the "sexual quality of life-female" questionnaire, quantitative sensory tests and the improvement reported by the patient in arousal and orgasm. evaluations will be carried out before treatment, at the end of the treatment, and at 3 and 6 months after the end of treatment.

Eligibility criteria:
inclusion criteria: * women with incomplete spinal cord injury b, c or d (with preservation of the sacral arch and sensitive assessment of the lower dermatomes not absent, paying special attention to the sensitivity of the genital area) level below t6. * between 18-60 years * hormonal analysis. participants do not present menopausal values of the hormone fsh (follicle stimulating hormone ) (31- 134 u / l) * present some type of sexual disorder secondary to spinal cord injury with at least 12 months of evolution * from spain * willing to attend the evaluation and treatment center * seeking to improve in the sexual area. exclusion criteria: * women with active pregnancy * present pre-existing pathologies in the genital area * genital malformation, previous neurosurgery that affects the genital response capacity * sexual disorders before the injury * pressure ulcers, serious medical illness or any type of pathology in which the use of sick leave is contraindicated frequency * psychiatric disorder, narcotic dependence, use of specific serotonin reuptake inhibitors, antipsychotics or other drugs that affect sexual response. * does not sign the informed consent.

Keywords: spinal cord injuries women pelvic floor disorders sexuality
shared book reading to promote mental well-being among young people with and without down's syndrome

Conditions: Down Syndrome

Summary: abstract background: with the progress of society and the deepening of people's understanding of down syndrome (ds), research has shifted focus on how to improve the quality of life and education for young people with ds. this study shall pilot a shared book reading intervention to test for potential benefit and feasibility. methods: this study is an 8 weeks long pilot dyadic randomized controlled trial (rct) comparing a shared book reading intervention to a minimal activity control, this study will then continue for 12 months as a single arm cohort study. young people with ds and university undergraduate students will be recruited and formed into dyads then randomized to either intervention or control. the shared book reading activity will include partnering young people with ds and university students together for a weekly, 1-hour shared book reading session. the control group will be supplied with three books they can read in their free time during 8 weeks. the primary outcomes included young people with ds health-related quality of life measured using the children's quality of life scale (pedsql4.0). secondary outcomes include mental well-being in university students using the engagement, perseverance, optimism, connectedness, and happiness scale (epoch). measurements will be made at baseline (t0) and 8-week (t1). after 8 weeks all participants will be offered to continue in the study where all participants will join the shared book reading weekly intervention and outcomes measures will be made at 6-month (t2), and 12-month (t3) follow-up. mixed linear regression models shall be conducted comparing intervention and control group at 8 weeks. at 6-months and 12-months follow-up change scores from baseline will be analyzed to test for potential long-term effect. anticipated results: if our pilot study can show that shared book reading activities for people with ds can be of benefit and feasible, this can lead to a fully powered randomized controlled trial.


Eligibility criteria:
inclusion criteria for participants with down syndrome (ds): * clinical diagnosis of down syndrome (ds). * aged 2 years or older. * able to participate in the intervention and study evaluation independently or with the support of caregivers or family members. inclusion criteria for university of macau (um) students: * aged 18 years or older. * able to read and understand books in english or chinese. * able to communicate in english, mandarin, or cantonese. * do not have severe visual or reading disabilities that may affect reading ability. exclusion criteria: -have severe visual or reading disabilities.
understanding covid-19 vaccine immunity in tissue and blood

Conditions: COVID-19 (Coronavirus Disease 2019)

Summary: the purpose of this study is to understand the effects of covid-19 vaccines on the immune system and how the covid-19 vaccines provide protection and induce long term memory. adults who are receiving a covid-19 vaccine will be invited to participate in this study.


Eligibility criteria:
inclusion criteria: * adults 18yrs old and higher who are receiving a covid-19 vaccine exclusion criteria: * pregnancy * patients with contraindications for lymph node biopsy * active cancer * current use of immunosuppression drugs

Keywords: immunity vaccine
association between hidradenitis suppurativa and spondyloarthritis

Conditions: Hidradenitis Suppurativa

Summary: hidradenitis suppurativa is a chronic dermatosis, characterized by an inflammation of the follicular epithelium in the apocrine glands. the hypothesis of a link between hidradenitis suppurativa and inflammatory rheumatism has been widely considered, with evidence in support of this theory accumulating from several case reports and small series. the most frequently cited rheumatismal disease thought to be associated with hidradenitis suppurativa is spondyloarthritis. taken together, these data suggest that there may a link between hidradenitis suppurativa and spondyloarthritis, but literature data are sparse, and to date, no study has investigated or demonstrated such a relation. indeed, existing studies to date were observational, descriptive, and retrospective, and did not use modern diagnostic approaches for documenting spondyloarthritis, such as magnetic resonance imaging (mri) or the recent classification of spondyloarthritis.

the aim of the study was to test the hypothesis that the risk of spondyloarthritis is increased in patients with hidradenitis suppurativa.

Eligibility criteria:
inclusion criteria: * for case: patients with diagnosis of hidrosadenitis suppurativa in the department of dermatology of the university hospital of reims, regardless of the stage of severity and duration of their disease * for control: patients without diagnosis of hidrosadenitis suppurativa matched to cases for age (±5 years) and sex * for case and control: have accepted to take part in the research exclusion criteria: * for case and control: age \<18 years old

Keywords: spondyloarthritis hidrosadenitis suppurativa inflammation magnetic resonance imaging
renal resistive index as an indicator of lupus nephritis severity and systemic lupus activity

Conditions: Systemic Lupus Erthematosus; Lupus Glomerulonephritis; Lupus Flare

Summary: the study explores the role of the colour doppler scanning of the renal arteries and its relation to the degree of disease affection in lupus nephritis

we have recruited patients into 3 groups the first group is patients with lupus nephritis the second groups is patients with systemic lupus erythromatosus without nephritis the third groups is normal healthy controls we explored the association of colour doppler and the renal resistive index with the degree of the renal affection in lupus nephritis

Eligibility criteria:
inclusion criteria: * 1. systemic lupus erythematosus. 2. lupus nephritis. 3. adults \>18 years old. exclusion criteria: * 1. end stage renal disease. 2. diabetes mellitus. 3. heart failure. 4. hepatic diseases. 5. obstructive nephropathy. 6. renal artery stenosis or occlusion.

Keywords: systimc lupus erythromatosus lupus glomerulonephritis
effect of valdecoxib pretreatment on pain and secondary hyperalgesia in healthy volunteers

Conditions: Pain; Hyperalgesia

Summary: tis study was designed to test the hypothesis that pretreatment with valdecoxib, prior to injury could reduce or prevent the development of secondary hyperalgesia around the area of primary injury. a heat/capsaicin model of induced hyperalgesia was tested in healthy volunteers in a randomized, double blind, cross-over trial of a single dose of 40 mg vadecoxib versus control. subjects rated pain intesnsity and unpleasantness following heat stimulation of the forearm, the area of hyperalgesia was also mapped over the course of the experiment.


Eligibility criteria:
inclusion criteria: * healthy male of non-pregnant female; 18yo or older * not currently taking nsaid * able and willing to provide informed consent * willing to avoid other nsaids in 24 hour period following study * no known hypersentitivites or contraindications to nsaids, sulfonomides or capsaicin exclusion criteria: * pregnant or breast feeding * use of nsaids or other analgesic medications in past 7 days * unwilling or unable to give informed consent * contraindication to any study medication or other nsaid

Keywords: pretreatment healthy volunteers
anesthesia and eeg discontinuity in infants

Conditions: Anesthesia, General; Electroencephalography; Infant; Anesthesia, Inhalation

Summary: this study is a randomized controlled trial to evaluate whether eeg-guided calibration of inhalation agents can reduce occurrence of eeg discontinuity in infants during general anesthesia.

this is a study for comparison of incidence of eeg discontinuity during general anesthesia using sevoflurane. eeg guidance group will receive calibration of fraction of inhalational sevoflurane according to components of slow wave and delta wave of raw eeg. control group will receive conventional management of anesthesia according to vital signs.

Eligibility criteria:
inclusion criteria: * infants who were born as full-term (\>37 weeks postconception) and are equal to or less than 12 month old who were scheduled to undergo surgery under general anesthesia using inhalation agents. * belongs to american society of anesthesiologists physical status 1 or 2 exclusion criteria: * infants who were born less than 37 weeks postconception or has history of mechanical ventilation immediately after birth * presence of any genetic disease, chromosomal anomaly or congenital anomaly that can affect brain development * presence of any disease or disability in central nervous system * history of trauma at head or surgery on brain * history of hypersensitivity to any anesthetic agents * status of sedation or endotracheal intubation before induction of anesthesia * inability to attach probes for eeg monitoring * expectation of operation time as less than 5 minutes * other conditions that researchers regard as inappropriate for enrollment

Keywords: electroencephalography infant general anesthesia burst suppression sevoflurane