Kornimate/medical-research-clean huggingface dataset:
comparison between fentanyl and dexmedetomidine as adjuvant to bupivacaine in combined ipack and adductor canal block for postoperative analgesia after knee surgeries

Conditions: Analgesia, Postoperative

Summary: this study will be undertaken to compare the analgesic effects of of fentanyl versus dexmedetomidine as adjuvant to bupivacaine in combined ipack and acb for pain management after total knee arthroplasty.

* to measure the total amount of rescue analgesic consumption in the first 48 hours post-operatively in each group * to assess pain score in each group by using numerical rating scale (nrs) at rest (static) and during flexion or extension of knee (dynamic) at different time points: pacu, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs and 48 hrs. * to measure the time of first request of rescue analgesia in each group * to record the incidence of adverse events (hematoma, local anesthetic toxicity, infection, nausea and vomiting) and length of hospital stay. * over all patients' satisfaction: the patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia).

Eligibility criteria:
inclusion criteria: 1 - patient acceptance 2. cooperative patients 3. age: ≥21 and 85\< years' old 4. sex: both sexes (males or females). 5. physical status: asa ι \& ii\& ш. 6. body mass index (bmi): ≤ 35 kg/m2. 7. type of operation: elective unilateral knee surgeries (tka, acl, knee arthroscopy) exclusion criteria: . patient with any contraindications of regional blocks (as coagulopathy or local infection at injection site) 2. patients with known history of allergy to the study drugs (bupivacaine, dexmedetomidine and fentanyl). 3. advanced hepatic, renal, cardiovascular, neurologic and respiratory diseases. 4.chronic opioid use (more than 3 months or daily oral morphine \> 5 mg /day for 1 month) -

Keywords: fentanyl dexamedetomidine analgesia ipack and adductor canal block knee surgeries
pharmacokinetics, efficacy, safety, and immunogenicity of wilate in previously treated paediatric patients with severe haemophilia a

Conditions: Severe Hemophilia A

Summary: a prospective, non-controlled, international, multi-centre phase 3 study to investigate the pharmacokinetics, efficacy, safety, and immunogenicity of wilate in previously treated children with severe haemophilia a


Eligibility criteria:
inclusion criteria: 1. severe haemophilia a (\<1% fviii:c) according to medical history 2. male patients aged 1 to \<12 years 3. previous treatment with a fviii concentrate for at least 50 exposure days (eds) 4. immunocompetence (cd4+ count \>200/μl) 5. voluntarily given, fully informed written and signed consent obtained by the patient's parent(s) or legal guardian and, depending on the children's developmental stage and intellectual capacity, informed assent by the patients before any study-related procedures are performed the interval between the screening visit and the pk visit should not exceed 30 days. if the 30-day interval is exceeded, determination of the cd4+ count is to be repeated and must be \>200/μl for patients to be enrolled (i.e., inclusion criterion no. 4). exclusion criteria: 1. any coagulation disorders other than haemophilia a 2. history of fviii inhibitor activity (≥0.6 bu) or detectable fviii inhibitory antibodies (≥0.6 bu using the nijmegen modification of the bethesda assay) at screening, as determined by the central laboratory 3. severe liver or kidney diseases (alanine aminotransferase \[alat\] and aspartate transaminase \[asat\] levels \>5 times of upper limit of normal, creatinine \>120 μmol/l) 4. patients receiving or scheduled to receive immunomodulating drugs (other than antiretroviral chemotherapy), such as alpha-interferon, prednisone (equivalent to \>10 mg/day), or similar drugs
assessment of cmv-specific elispot assay for predicting cmv infection in bone marrow transplant recipients (ace-bmt)

Conditions: Bone Marrow Transplantation

Summary: cmv is one of the most important opportunistic infection in transplant recipients. in south korea, more than 95% of adults reveal sero-positivity for cmv igg. until now, sero-positivity for cmv igg before bone marrow organ transplantation is a laboratory test of choice to stratify the risk of cmv reactivation after solid organ transplantation. theoretically, cmv-specific cell-mediate immune response before and after bone marrow transplantation will further categorize the patients into high or low risk of cmv development after bone marrow transplantation. the investigators thus evaluate the usefulness of cmv-specific elispot assay in bone marrow transplant candidates to predict the development of cmv infection after transplantation.

we will evaluate whether cmv-specific cell-mediated immune response before transplant, 1 month, 3 months, and 6 months after transplantation will predict cmv infection after bone marrow transplantation.

Eligibility criteria:
inclusion criteria: * age 16 or more * agree with written informed consent exclusion criteria: * no exclusion criteria
omacor and placebo in carotid plaque stability

Conditions: Cardiovascular Disease

Summary: the purpose of this study is to investigate the effect of intake of omacor (omega-3-acid ethyl ester 90) 2g/day on specified parameters related to the stability of carotid plaque in patients awaiting endarterectomy.

there is evidence both from epidemiological studies and large clinical trials that consumption of long-chain omega-3 polyunsaturated fatty acids (pufa) found in oily fish and fish oils, protects against cardiovascular disease in western populations. the large clinical trial gissi-prevention showed radical reductions in cardiovascular disease and sudden cardiac death after the intake of omega-3 pufa, and statistically significant effects were seen after only a few months of use. one of the models for explaining this markedly effect hypothesizes that omega-3 pufa, with its anti inflammatory effects, might act to stabilize atherosclerotic plaques by decreasing infiltration of inflammatory cells into the plaques and/or by decreasing the activity of these cells once resident in the plaque. a previous clinical study has showed increased incorporation of the omega-3 fatty acids epa and dha in carotid plaque after intake of omega-3 pufa. the morphological properties of the plaque was also altered, showing thicker fibrous caps and less inflammation determined by the aha and modified aha classification. these findings are important to confirm. secondly additional indicators of plaque stability are required to strengthen the hypothesis. also the mechanisms by which the morphological changes come about need to be identified. the model that is being used assesses structural changes associated with plaque rupture and instability through different important variables. comparisons: double blind comparison of omacor 2g/day and placebo in patients awaiting endarterectomy.

Eligibility criteria:
inclusion criteria: * males of females above 18 years of age * patients awaiting carotid endarterectomy * written informed consent exclusion criteria: * patients consuming fish oil or evening primrose oil preparations * patients eating \> 2 oily fish meals per week * patients requiring operation within 7 days * pregnant or breastfeeding * patients participating in other clinical studies involving treatment with drug

Keywords: omacor omega-3 pufa endarterectomy carotid plaque stability structural changes inflammation
safety and efficacy study of betaxon 0.5% and azopt 1.0% in pediatric patients with glaucoma or ocular hypertension

Conditions: Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to evaluate the safety and efficacy of both betaxon and azopt in pediatric patients. patients will dose with study drug at 8 am and 8 pm daily for twelve weeks. patients will have vision tested, slit lamp exam, blood pressure and pulse checks at each visit. patients will have a dilated fundus exam and corneal measurements taken at first and last visit.


Eligibility criteria:
inclusion: * children 5 years old and younger * require treatment for glaucoma or ocular hypertension * vision is 20/80 or better * cup-to-disc ratio of 0.8 or less exclusion: * do not have abnormal fixation * iop greater than 36 mm hg * significant retinal disease * penetrating keratoplasty * severe ocular pathology * optic atrophy * eye surgery in the past 30 days * cardiovascular abnormalities * hypersensitivity to beta blockers, carbonic anhydrase inhibitors or sulfa drugs

Keywords: glaucoma ocular hypertension
effects of hesperidin on bone biomarkers in postmenopausal women

Conditions: Osteopenia; Osteoporosis

Summary: the primary objective of this clinical trial is to determine the effects of hesperidin on biochemical markers of bone in post-menopausal women. the secondary objectives are: * to investigate changes in bone formation and bone resorption markers in response to hesperidin intake * to compare the efficacy of hesperidin in a milk versus biscuit * to collect safety information of hesperidin consumption in a human trial


Eligibility criteria:
inclusion criteria: * community dwelling women * more than 4 years post-menopause (natural or surgical) * generally healthy as determined by standard medical assessment on physical and mental health * willing to comply with the study procedures * willing to accept use of all nameless data, including publication, and the confidential use and storage of all data * having received both oral and written explanations about the study * having provided her written informed consent exclusion criteria: * intestinal or severe metabolic diseases / disorders such as diabetes, renal, hepatic or pancreatic diseases / disorders, ulcer, hyperthyroidism, malignance, chronic malnutrition * have had major gastrointestinal surgery * on therapy with drugs known to interfere with bone metabolism such as steroids, vitamin d or its derivatives, bisphosphonates, strontium ranelate, pth, calcitonin, raloxifene, etc. * had sustained a fracture in the preceding 12 months * on hormone replacement therapy (hrt) in the previous 3 months before entering the study * taking medications containing hesperidin (e.g.daflon) or known to interfere with hesperidin (statins, therapy for circulatory disorders, anti-depressants) * known to have allergic reactions to citrus-containing foods * baseline calcium intake less than 500 mg/day * have an alcohol intake \> 2 glasses of wine per day (3dl/day), or \> 2 beers (3dl/d) or \> 1 shot glass of hard alcohol * heavy smoker (more than 10 cigs a day) * special dietary habits (vegetarians) * phytoestrogens or antioxidants (dietary supplements) consumption
study of the impact of inlyta in 2nd line on the treatment outcomes of mrcc patients treated with sutent in 1st line in the real life setting

Conditions: Metastatic Renal Cell Carcinoma (mRCC)

Summary: this is an international, multi-centre, prospective (partly retrospective), observational study to evaluate treatment patterns and clinical outcomes in patients with advanced or metastatic rcc treated with sunitinib in first line and/or receiving axitinib in second line post sunitinib. the study is designed to enroll approximately 750 patients over the course of an enrollment period of approximately 36 months.

patients will be enrolled when they start a treatment with sutent in 1st line or inlyta in 2nd line post sutent treatment. the possible sequences of treatment under investigation will be: * sutent (prospective) - inlyta * sutent (retrospective) - inlyta * sutent - not further active treatment (supportive care) * sutent - other second line treatment (nexavar (sorafenib), votrient (pazopanib), afinitor (everolimus), torisel (temsirolimus), other)) the study will enroll approximately 750 adv/mrcc patients at the 1st and 2nd line treatment level. patients will be enrolled when they start a treatment with sutent in 1st line or inlyta in 2nd line post sutent treatment. therefore for some patients there will be a retrospective sutent data collection. the primary endpoints of this study in patients with adv/mrcc are pfs and ttf for patients receiving inlyta in 2nd line, and the combined pfs and ttf for patients receiving the sutent-inlyta sequence. in this non-interventional real life study, the objective is only descriptive and the sample size will rely on the precision of the estimate.

Eligibility criteria:
inclusion criteria: * patient 18 years of age and over * histologically confirmed diagnosis of advanced/metastatic renal carcinoma (clear cell rcc as well as non-clear cell rcc) with measurable disease according to recist 1.1 * patients being treated with sutent in 1st line according to the european therapeutic indication and/or being treated with inlyta in 2nd line according to the european approved therapeutic indication (except post cytokines) * evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criteria: * patients being treated with cytokines or any other treatment outside of sutent in 1st line * patients receiving anti -tumor treatment beyond a second line * patients already under sutent, already under inlyta: enrolment must occur at the beginning of each line of treatment (before or at the first follow up visit at the latest)

Keywords: inlyta axitinib sutent sunitinib renal
transcutaneous electroacupuncture for gastric complications of scleroderma

Conditions: Scleroderma; Gastroparesis

Summary: an innovative method of needleless transcutaneous electroacupuncture (tea) using a newly developed watch-size stimulator is proposed. weak electrical current will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions. the stimulator can be attached to the skin near the acupuncture points and therefore daily activity of the patient does not need to be altered. two experiments are designed to prove the feasibility of the proposed therapy for gastric complications of scleroderma .


Eligibility criteria:
inclusion criteria: * no any systemic diseases; * no scleroderma; no history of gastrointestinal surgery; * no dyspeptic symptoms during the past 2 weeks; * not taking any medications except contraceptives during the past 2 weeks; * age 18 and older. exclusion criteria: * history of any systemic diseases or surgeries; * allergic to adhesives; pregnancy; * unable to sign the consent form.

Keywords: transcutaneous electroacupuncture
a study to determine frequency of dna-repair defects in men with metastatic prostate cancer

Conditions: Metastatic Prostate Cancer

Summary: the purpose of this study is to evaluate the prevalence of 4 or more dna-repair gene defects in a population of men with metastatic prostate cancer (pc) and to use the reported dna-repair gene defects to assess biomarker eligibility for niraparib interventional studies.


Eligibility criteria:
inclusion criteria: * diagnosis of metastatic (stage iv) prostate cancer (pc), confirmed by either biopsy of a metastatic tumor site or history of localized disease supported by metastatic disease on imaging studies (that is \[i.e.\], clearly noted in hospital/clinical records) * signed informed consent form (icf) * no condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example \[e.g.\], compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments * willing to provide a saliva, blood, and/or archival tumor tissue sample for genomic analysis * no prior poly (adenosine diphosphate \[adp\]-ribose) polymerase inhibitor (parpi) for the treatment of prostate cancer * no prior dna-repair gene defect test results from a janssen sponsored interventional trial
a study to compare two ways of completing pain and sleep questions and to evaluate a new daily questionaire for assessing fatigue in fibromyalgia patients

Conditions: Fibromyalgia

Summary: the study has two goals. the first goal of the study is to compare two methods of administering questions about pain and sleep interference. the two methods being compared are a telephone based system and an electronic hand held diary. the second goal of the study is to evaluate a daily diary to evaluate fatigue symptoms in patients with fibromyalgia.


Eligibility criteria:
inclusion criteria: * fibromyalgia using acr diagnosis exclusion criteria: * other confounding disease including other inflammatory disease, pain and depression

Keywords: fibromyalgia methodology pain sleep fatigue
use of ultrasonic bone scalpel in adolescent idiopathic scoliosis

Conditions: Adolescent Idiopathic Scoliosis; Posterior Spinal Fusion

Summary: the primary purpose of this randomized trial is to compare the efficacy of an ultrasonic bone scalpel (or osteotome device) with standard of care surgical instruments during posterior spine fusion with instrumentation.


Eligibility criteria:
inclusion criteria: 1. 10-18 years of age 2. diagnosis of adolescent idiopathic scoliosis (ais) 3. scheduled for a posterior spinal fusion (without schwab grade ii or higher osteotomy) exclusion criteria: 1. plan for a posterior column osteotomy of schwab grade ii or higher 2. prior spinal surgery 3. magnetic resonance imaging (mri) abnormalities (such as syrinx and/or chiari malformations) 4. subjects with medical comorbidities (e.g. heart, lung, kidney disease) 5. subjects with bleeding diatheses 6. non-idiopathic etiology for scoliosis

Keywords: ultrasonic bone scalpel adolescent idiopathic scoliosis posterior spinal fusion estimated blood loss
satisfaction survey for the outpatient unit dedicated to post-cancer treatment

Conditions: Breast Cancer; Ambulatory

Summary: the care pathway for breast cancer is complex, punctuated by consultations, complementary examinations and treatments. patients benefit from close medical and paramedical support. at the end of the treatment, the post-cancer phase begins and the surveillance begins. the national cancer institute's (inca) ten-year cancer control strategy for 2021-2030 defines in its second axis the objective of limiting the after-effects and improving the quality of life of cancer patients. indeed, ensuring rapid access to functional rehabilitation and post-treatment reconstruction, and setting up personalized and graduated follow-up between the city and the hospital, are crucial. better information for patients on the post-cancer period is a way for them to acquire greater autonomy, to enable them to take an active role in it and to approach it with greater serenity. the paris saint-joseph hospital group (ghpsj) has therefore created an outpatient medical unit (umab) dedicated to post-cancer treatment in july 2021. it is offered to all patients who have had localized breast cancer and have received curative treatment. each patient, 3-4 months after the end of treatment (surgery and/or chemotherapy and/or radiotherapy), will benefit from a half-day session including 3 consultations: medical, nursing and physiotherapy. the medical consultation allows for additional information if there are any questions about the care received, a clinical examination, reassessment of the tolerance of adjuvant hormone therapy if it is indicated, and delivery of the personalized post-cancer program (ppac). the nursing consultation is conducted by a person certified in therapeutic patient education. numerous items are discussed, with the aim of identifying personal difficulties (financial, family or work-related, for example) that may hinder post-cancer rehabilitation, detecting specific support care needs and promoting post-cancer health (encouraging normal weight, smoking cessation, recommended nutritional factors and physical activity). finally, the physical therapy consultation consists of a joint, muscle and scar assessment to promote normal functionality and the implementation of recommended physical activity. imaging examinations (cardiac ultrasound and/or mammography/ultrasound and/or bone densitometry) may be associated with the consultation. as part of investigator's quality and continuous improvement approach, investigators would like to collect the opinions of patients who have benefited from the umab post breast cancer since its creation.


Eligibility criteria:
inclusion criteria: * patient whose age is ≥ 18 years * patient who has participated in post-cancer umab for breast cancer * french-speaking patient exclusion criteria: * patient under guardianship or curatorship * patient deprived of liberty * patient under court protection * patient objecting to the use of her data for this research
relation between position of the uterus (anteversion or retroversion flexion) and degree of cesarean scar niche

Conditions: Anteversion of Uterus; Retroflex Uterus; CSD

Summary: this study aims to determine the association between the size of caesarean scar niche and uterine position in childbearing women. research hypothesis: there is a relation between uterine position and degree of cesarean scar niche. research question: is there a relation between uterine position and degree of cesarean scar niche?

it has been noted that the cesarean scar defect in patients with retroflexed uteri appear to be larger than are those in patients with anteverted uteri. this study will describe the association between position of the uterus whether share in degree of cesarean scar niche or not and associated symptoms. primary outcome: the association between the position of the uterus (anteverted/retroverted) and large csd (the ratio between the depth and adjacent myometrial thickness) secondary outcomes: the association between position of the uterus (anteverted/retroverted) and: * residual myometrial thickness (rmt). * depth, width, length of scd. the association to the clinical symptoms as: * postmenstrual spotting: more than 2 days of intermenstrual spotting, or more than 2 days of brownish discharge after the end of menstruation if bleeding duration exceeds 7 days (discharge is considered normal if bleeding duration is \< 7 days). * abnormal uterine bleeding (aub) as per figo guideline. * pain as dysmenorrhea, chronic pelvic pain or dyspareunia. if present will be assed using visual analogue scale (vas). * secondary infertility: inability of a couple to conceive after one year of regular, unprotected intercourse.

Eligibility criteria:
inclusion criteria: * women in childbearing age. * at least six months postpartum. * with cesarean scar niche/defect (csd) by transvaginal ultrasound that is defined as "indentation at the site in the cesarean section scar with a depth of at least 2 mm" that was agreed upon in 2019 by a european task force exclusion criteria: * severely obese (body mass index; bmi more than or equal to 35 kg/m2). * women with abnormal uterine pathology, observed during the ultrasound examination that may have been responsible for abnormal uterine bleeding, including endometrial hyperplasia, polyps, malignancy or myomas. * women with any cause of pelvic pain as pelvic inflammatory diseases, endometriosis or adenomyosis. * women with history of classic upper segment cesarean section or hysterotomy. * women with history of previous uterine scars rather than cesarean sections as myomectomy. * women with bleeding tendency disorders, taking anticoagulants or having chronic medical conditions as liver diseases, or coagulopathies.

Keywords: cesarean scar defefect isthmocele caesarean scar niche anteverted uterus retroverted uterus