Kornimate/medical-research-clean huggingface dataset:
efficacy of secukinumab compared to ustekinumab in patients with plaque-type psoriasis

Conditions: Chronic Plaque Type Psoriasis

Summary: this study assessed efficacy of secukinumab, compared to ustekinumab, in patients that have plaque-type psoriasis


Eligibility criteria:
inclusion criteria: * patients with moderate to severe plaque type psoriasis for at least 6 months before randomization * patients eligible for systemic therapy with inadequately controlled psoriasis exclusion criteria: * forms of sporiasis other than plaque type psoriasis * previous exposure to secukinumab, ustekinumab, or other biologic drugs targeting (il)-17a or il-17ra other protocol-defined inclusion/exclusion criteria may apply

Keywords: chronic plaque type psoriasis, secukinumab, ustekinumab, inflammatory skin disease, scaling
the effect of sodium on erythrocyte salt sensitivity, syndecan-1 and heparin sulfate in healthy subjects.

Conditions: Sodium; Renal Function; Blood Pressure

Summary: the study was a double-blinded, randomized, placebo-controlled cross-over study. 27 healthy subjects received a four days standardized, sodium reduced diet (100 mmol sodium) and treatment with sodium chloride (200 mmol sodium) or placebo in a randomized order. after the treatment the subjects went to an examination day. with 1 l isotonic sodium chlorid intravenous in 25 minutes, the subjects were further sodium and volume loaded. change in salt blood test (sabt), syndecan-1(syn-1) and heparan sulfate (hs), brachial and central blood pressure (bp), pulse wave velocity (pwv) and augmentation index (aix) were measured. baseline blood samples were taken before the treatment periods

background: the endothelium is lined with endothelial glycocalyx (eg). eg protects the endothelium and functions as a barrier between blood and endothelium. due to negative charges eg has a strong ability to buffer sodium. in vitro studies indicate that sodium overload can damage the eg and reduce the sodium buffer capacity. this could cause endothelial dysfunction and might lead to cardiovascular disease. eg can be measured by the erythrocyte salt sensitivity (ess) and shedding of glycocalyx. purpose: the investigators aimed to examine the effect of dietary sodium balance on eg in healthy subjects. methods: in a double blinded, randomized, placebo controlled cross over study, 27 healthy subjects received a four days sodium reduced diet and treatment with nacl or placebo in randomized order. afterwards the subjects were further sodium and volume loaded with 1 l isotonic nacl intravenously. changes in ess and blood pressure were measured.

Eligibility criteria:
inclusion criteria: * both gender * age 18-50 years, * bmi 18.5-30.0 kg/m2, * signed concent. * fertile women with safe contraception during the whole examination period. exclusion criteria: * alcohol consumption \> 7 drinks per week for women and, \> 14 drinks per week for men. * smoking, * substance abuse * current use of medicine except contraception, * office bp \> 140/90 * history or signs of clinically relevant kidney, heart, liver, lung, neurological, or endocrine diseases, neoplastic disorders, * pregnancy or lactation * blood donation within 1 month of the first investigation, * clinically relevant abnormal blood/urine sample or electrocardiography. withdrawal criteria: * development of exclusion criteria * suspicion of poor compliance to study medication * withdrawal of signed concent.

Keywords: sodium renal handling
nasally delivered pulmozyme for sinusitis in cystic fibrosis

Conditions: Sinusitis; Cystic Fibrosis

Summary: chronic sinusitis is a frequent complication in cystic fibrosis. the aim of this study is to determine whether pulmozyme(dornase alfa) would maintain sinus health (compared to placebo) in patients with cystic fibrosis who have recently undergone sinus surgery.

aim: to evaluate the effectiveness of pulmozyme(dornase alfa) in decreasing post-operative sinusitis symptoms in patients with cystic fibrosis (cf) procedures: 20 patients with cf will be randomized to receive either pulmozyme or placebo via nasal inhalation daily for 12 months. consent will be obtained following surgery and treatment will begin 1 week post-operatively. monitoring will include examination and recording of adverse effects and follow up weekly for one month and then at 2.5, 6, 9 and 12 months. outcome measures will include ciliary function testing, pulmonary function testing, sinus questionnaires and ct scan.

Eligibility criteria:
inclusion criteria: * clinical and laboratory diagnosis of cystic fibrosis * age greater than or equal to 5 years * forced expiratory volume in 1 second (fev1) greater than or equal to 40% predicted * sinus surgery within one week of enrollment exclusion criteria: * pregnancy * intolerance of orally inhaled pulmozyme (dornase alfa)

Keywords: cystic fibrosis chronic sinusitis mucolytic
pregabalin for postoperative pain in women undergoing breast cancer surgery

Conditions: Postoperative Pain

Summary: we hypothesize that pregabalin will decrease postoperative pain, as measured by the surrogate markers postoperative pain rating scores and postoperative opioid consumption while improving the quality of recovery following breast cancer surgery compared to placebo. the primary outcome will be postoperative pain, measured by a nrs and the quality of recovery score (qor) in the first 24h postoperative period. do women undergoing breast cancer surgery with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower nrs and a greater qor score in the first 24 hours after their surgery than those women who received placebo?


Eligibility criteria:
inclusion criteria: 1. american society of anesthesia physical status class i \& ii 2. age ¬\< 65 years 3. english-speaking 4. unilateral breast cancer surgery without axillary node dissection (i.e. simple mastectomies and lumpectomies +/- "sentinal" node biopsy) exclusion criteria: 1. known or suspected allergy, sensitivity, or contraindication to pregabalin 2. known or suspected allergy to morphine, nsaids, acetaminophen or oxycodone 3. morbid obesity (body mass index ≥ 45 kg/m2) 4. history of a seizure disorder 5. pregnancy 6. current pre-operative therapy with pregabalin, gabapentin, or any opioid 7. any other physical or psychiatric condition which may impair their ability to cooperate with postoperative study data collection 8. crcl \< 60 ml/min \[crcl = 0.85 x ((140 - age) x weight(kg)) / (72 x cr(mg/dl)))\]

Keywords: pain, pregabalin, lyrica, breast surgery
the 'bone-brain' crosstalk mechanism of subchondral bone nociceptive sensitization activating spp1-positive microglia in the vlpag region elucidates the theoretical connotation of treating knee osteoarthritis based on kidney differentiation

Conditions: Osteoarthitis

Summary: the aim of this observational study is to investigate the relationship between pain severity and alterations in bone-derived and brain-derived signaling molecules (including serum neurotransmitters and inflammatory cytokines), as well as structural and functional changes in the ventrolateral periaqueductal gray (vlpag) region in patients with kidney-deficiency type knee osteoarthritis (koa). the central question it seeks to address is whether changes in these signaling molecules and vlpag alterations are associated with the degree of pain. patients scheduled to undergo total knee arthroplasty (tka) due to koa will be enrolled prior to surgery. before the operation, they will undergo questionnaire assessments, physical examinations, imaging evaluations, and blood sample collection. the resected tibial plateau tissue obtained during surgery will be used for subsequent laboratory analyses.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of koa * age between 60-70 years. * kellgren-lawrence grade iv on anteroposterior and lateral knee x-rays. * scheduled for total knee arthroplasty. * voluntarily signs informed consent. exclusion criteria: * clinical diagnosis of ankylosing spondylitis, rheumatoid arthritis, gout, or other related conditions. * presence of metabolic bone diseases, acute trauma, malignancies, infections, or other complications severely affecting knee function. * use of drugs affecting bone metabolism (e.g., corticosteroids, zoledronic acid) within the past 6 months. * presence of psychiatric disorders or serious cardiovascular, pulmonary, renal, hepatic, hematologic, or other systemic diseases. * contraindications to mri.
efficacy of implant surface characteristics in patients with history of periodontitis

Conditions: Marginal Bone Loss

Summary: the aim of the study is to evaluate in patients with history of periodontitis the clinical, microbiological and radiological outcomes of implants with a modified implant design consisting on a machined surface in the coronal third of the implant. in this 12-month, parallel-arm, randomized controlled trial, patients with history of treated periodontitis and in need of dental implants for single-unit or short edentulous spaces (i.e. two implants) will be randomly assigned to a test group (implants with a hybrid surface, presenting a machined coronal third; hs) or a control group (conventional moderately rough implants; rs). implants will be restored 3 months later with fixed implant supported reconstructions. radiological, clinical, microbiological and patient-related outcome measures (proms) will be assessed 3, 6 and 12 months after the prosthetic installation.


Eligibility criteria:
inclusion criteria: •\> 20 years of age * presence of ≥1 adjacent missing teeth, in either maxilla or mandible (up to three missing units). * a natural tooth had to be present mesially to the most proximal implant site, although free end situations were allowed, and opposing dentition had to be natural teeth or implant supported fixed restorations. * history of treated and controlled periodontitis. * presence of adequate bone volume to achieve primary implant stability without concomitant regeneration exclusion criteria: * diseases affecting bone metabolism or wound healing (e.g.) * history of radiation therapy, leukocyte dysfunction, or any other immunodeficiency * drug abuse * intrasurgical exclusion criteria, such as the lack of primary stability, the need of bone augmentation or the impossibility of placing the implant based on prosthetic requirements. �

Keywords: implant surface hybrid peri-implantitis periodontitis marginal bone loss
study of tedizolid phosphate in adolescents with complicated skin and soft tissue infection (cssti) (mk-1986-012)

Conditions: Skin Diseases, Infectious; Skin Diseases, Bacterial

Summary: the purpose of the study is to compare the safety of intravenous (iv) and/or oral 6-day 200 mg tedizolid phosphate with 10-day comparator in participants 12 to \<18 years with cssti.

a randomized, single-blind, multicenter, phase 3 study of iv and/or oral tedizolid phosphate 200 mg once per day for 6 days compared with iv and/or oral comparator for 10 days for the treatment of cssti, also known as acute bacterial skin and skin structure infections, in participants 12 to \<18 years. cssti includes major cutaneous abscess, cellulitis/erysipelas, and wound infection.

Eligibility criteria:
inclusion criteria: * males or females 12 years to \<18 years * adequate venous access for iv administration of study drug for at least 24 hours (for participants receiving iv medication) and collection of protocol-specified blood samples * local symptoms must have started within 7 days before study day -1 * cssti meeting at least 1 of the clinical syndrome definitions. * suspected or documented gram-positive infection from baseline gram stain or culture. * parent/legally authorized representative (lar) able to give informed consent and willing and able to comply with all required study procedures. assent is also required of children who in the investigator's judgment are capable of understanding the nature of the study exclusion criteria: * uncomplicated minor skin and skin structure infections such as pustules, folliculitis, furuncles, minor abscesses (small volume of suppuration not surrounded by cellulitis/erysipelas), impetiginous lesions, superficial or limited cellulitis/erysipelas, and minor wound associated foreign body reactions (eg, stitch abscesses) * known bacteremia, severe sepsis or septic shock * recent history of opportunistic infections where the underlying cause of these infections is still active (eg, leukemia, transplant, acquired immunodeficiency syndrome) * hypersensitivity to tedizolid phosphate or any component in the formulation * hypersensitivity to all of the comparator drugs; hypersensitivity to a comparator drug does not preclude participation if an alternative comparator can be used * for participants with wound infections: history of hypersensitivity to ceftazidime, aztreonam, or any component of the aztreonam formulation, if aztreonam adjunctive therapy is required; history of hypersensitivity to metronidazole or any component of the formulation, if metronidazole adjunctive therapy is required * needs oral administration of methotrexate, topotecan, irinotecan or rosuvastatin, during administration of oral study drug. * uses monoamine oxidase inhibitors, tricyclic antidepressants, buspirone, selective serotonin reuptake inhibitors and serotonin 5 hydroxytryptamine receptor agonists (triptans) within 14 days prior to study drug administration
a phase ii study of degarelix in the management of non-metastatic hormone-refractory prostate cancer

Conditions: Prostatic Neoplasms

Summary: this study is being offered to patients who have hormone resistant prostate cancer (hrpc). this means that their prostate cancer is no longer responding to standard hormonal therapy. the purpose of this study is to determine whether degarelix will be able to stop the psa from rising in patients with hormone resistant prostate cancer.

this is a phase ii study of a gnrh antagonist drug, degarelix, for use in hormone resistant prostate cancer patients who have had biochemical psa progression despite the use of total androgen blockade therapy. patients will receive at least six monthly injections of degarelix unless the patient shows radiographic or symptomatic disease progression, intolerable toxicity or decides to withdraw from the study. patients will be evaluated for measures of efficacy, toxicity and disease progression during treatment and afterwards until radiologically confirmed metastatic disease progression or until the patient is removed from the study. overall objective: the efficacy of degarelix as a treatment for hrpc will be evaluated

Eligibility criteria:
inclusion criteria: * prior trial of total androgen blockade * confirmed biochemical psa progression on agonist therapy, defined as ≥ 50% increase in psa between 2 measurements, taken at least 1 week apart. in patients that are currently on total androgen blockade (lhrh agonist plus non-steroidal anti-androgen) there must be a trial withdrawal of androgen receptor antagonists to ensure that there is no psa response (6 weeks for bicalutamide and 4 weeks for flutamide or nilutamide). * radiologically confirmed non-metastatic disease within 90 days of registration based on negative chest radiographs, ct scan abdomen/pelvis and bone scan * ecog ≤ 2 * age ≥ 18 years * serum testosterone of ≤ 50 mg/dl * psa ≥ 2.0 ng/ml * white blood cell count ≥ 3000/mm3 * platelets ≥ 100,000/mm3 * serum creatinine ≤ 1.5 x upper limits of normal * bilirubin ≤ 1.5 x upper limits of normal * alanine transaminase ≤ 1.25 x upper limits of normal * estimated life expectancy of at least 12 months * able and willing to sign informed consent exclusion criteria: * prior treatment with chemotherapy, radiopharmaceuticals, estrogen, pc-spes, ketoconazole or other second line hormonal therapy (other than non-steroidal anti-androgens or androcur) * known allergy to gnrh agonists or antagonists * previous treatment with degarelix * major surgery within 4 weeks of registration * grade ≥ 3 peripheral neuropathy * severe, active co-morbidity such as unstable angina, congestive heart failure or myocardial infarction within the last 6 months or congenital long qt syndrome * acute deep vein thrombosis or pulmonary embolism * taking anti-arrhythmia medication * second malignancy other than non-melanoma skin cancer unless disease free ≥ 5 years. * prior orchiectomy for prostate cancer * psa \> 100 ng/ml

Keywords: prostate hormone-resistant degarelix firmagon anti-androgens total androgen blockade injection
effect of cavity disinfectants on post operative pain & success of partial caries removal

Conditions: Pulp Disease, Dental

Summary: to investigate the effect of sodium hypochlorite and chlorhexidine as cavity disinfectants on the post operative pain and success of partial caries removal in deep carious lesion with moderate pulpitis in permanent teeth

study design: intervention research question : to investigate whether the use of 2% chlorhexidine and 5.25% sodium hypochlorite can improve the clinical and radiographic outcome after partial caries removal in deep carious lesion p (population) - mature permanent mandibular molars with deep carious lesion involving inner two third of dentine i (intervention) - - partial caries removal using 2% chlorhexidine/5.25% sodium hypochlorite as cavity disinfectant.. c (comparison) - partial caries removal using saline as cavity disinfectant. o (outcome) - assessment of clinical and radiographic success at 12 months follow up. -to assess incidence and reduction in pain post operatively at every 24 hours till 1 week.

Eligibility criteria:
inclusion criteria: 1. the patient should be ≥18 years of age. 2. restorable mature permanent 1st and 2nd mandibular molars with extremely deep caries (≥2/3 dentine involvement) 3. tooth should give positive response to pulp sensibility testing. 4. clinical diagnosis of moderate pulpitis. 5. radiographic finding of periapical index (pai) score ≤2. 6. healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit) exclusion criteria: presence of vertical root fracture presence of root perforations asa-3 or asa-4 according to the classification of the american society of anesthesiologists) presence of root resorption combined endodontic-periodontic lesions. pregnancy
clinical data collection for the closed loop development for the type 2 diabetes treatment - dt2_1

Conditions: Type 2 Diabetes Treated With Insulin

Summary: the objective of this study is to collect the evolution of blood glucose levels in type 2 diabetes (t2d) patients under different conditions of their daily life: physical activity, meals, sleep, etc. this data will be used to develop a test bench to evaluate insulin delivery algorithms to treat patients with insulin-resistant t2d using a closed loop.

t2d is a condition that combines insulin resistance and relative insulin deficiency. the t2d naturally progresses towards an increasingly pronounced insulin deficiency that leads to the need for pancreatic replacement, by administering insulin. type 1 diabetes (t1d) requires a complete and immediate substitution of pancreatic insulin secretion. currently, patients need to be involved in managing their disease by deciding how much insulin to administer based on the results of glucose monitoring. artificial intelligence, thanks to a self-learning algorithm, enables the automation and customization of insulin administration. these devices, known as closed loops, bring real benefit to the patients included in the studies, by improving glycemic balance, by decreasing the number of hypo- and hyperglycemia but also by decreasing the mental load associated with the disease, improving their quality of life. these very significant benefits in the t1d treatment open the possibility of obtaining similar benefits in the t2d treated by the basal-bolus type insulin regimen. this study aims to develop a specific algorithm of t2d to meet its particular characteristics. the objective of this study is to collect the evolution of blood glucose levels in t2d patients under different conditions of their daily life: physical activity, meals, sleep, etc. this data will be used to develop a test bench to evaluate insulin delivery algorithms to treat patients with insulin-resistant t2d using a closed loop.

Eligibility criteria:
inclusion criteria: * patient with t2d treated with insulin pump for at least 6 months * patient with a body mass index (bmi) between 27 and 40 kg/m2 * patient treated with a total daily dose of insulin between 40 and 300 u/24 h * patient with cgm * patient with social security or beneficiary * patient able to read and understand the procedure, and able to express consent for the study protocol exclusion criteria: * patient with t1d * patient currently participating or having participated in the month prior to inclusion in another interventional clinical research that may impact the study, this impact is left to the investigator's discretion * persons referred to in articles l.1121-5 to l.1121-8 of the csp (corresponds to all the protected persons: pregnant woman (checked by the dosage of β-human chorionic gonadotropin for any woman wishing to participate in the protocol and in childbearing age 60 years), parturient, mother breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure)

Keywords: type 2 diabetes insulin life conditions algorithm closed loop
new tools for predicting capillary leak shock during dengue fever

Conditions: Dengue Fever; Children; Adults

Summary: evaluate the prognostic value of different methods (osmometry / clinical-biological score) compared to the occurrence of capillary leak shock during dengue fever.

on the south american continent, dengue fever progressively progresses to hyperendemia with co-circulation of different serotypes. among the complications of dengue fever, a frequent complication is the shock linked to capillary leakage which often occurs at the time of defervescence between the 3rd or 5th day of evolution of the fever. before that, it is difficult to identify patients who are at risk for severe forms. patients are therefore seen regularly to monitor for the development of serious forms, which causes saturation of the health system. despite everything, with each epidemic, the investigators observe deaths of previously healthy people, which always constitutes an important trauma for the population and for the carers. improving the understanding of the pathophysiology of capillary leakage and the tools to predict it would be significant advances in this common tropical pathology. thus a retrospective study of longitudinal data during the dengue 2 epidemic of 2013 made it possible to generate precise hypotheses as to the pathophysiology of the shock linked to capillary leakage. hypoprotidemia and hyponatremia having a strong statistical association with the subsequent occurrence of shock, the hypothesis is of a progressive disturbance of the plasma osmolarity resulting in water leaks towards the interstitial sector. these preliminary data also made it possible to develop a predictive score which must now be validated over time. research involving the human person, monocentric, prospective, validation interventional research protocol involving the human person category 2 at risk and minimal constraints

Eligibility criteria:
inclusion criteria: * age\> = 5 years * patient / parent consent * exclude other pathology with capillary circulation problem (septic shock, anaphylaxis) all suspected dengue fever requiring hospitalization will be included, final inclusion being after biological confirmation (agns1, rt-pcr, serology). exclusion criteria: * age \<5 years * refusal to participate * unsigned consent * coinfection by another agent * patient under guardianship or curatorship.

Keywords: dengue dengue fever children adults french guiana hypovolemic shock osmolarity hyponatremia hypoprotidemia clinical-biological score interstitial fluid