Kornimate/medical-research-clean huggingface dataset:
resveratrol's effects on inflammation and oxidative stress in chronic kidney disease

Conditions: Chronic Renal Insufficiency

Summary: inflammation and oxidative stress are common findings in patients with chronic kidney disease (ckd) undergoing conservative treatment, in addition to being associated with atherosclerotic process, are related also to the progression of ckd. in this regard, resveratrol, a phenolic compound with recognized antioxidant and anti-inflammatory properties, can play an important role in the control of metabolic disorders associated with ckd, since it can modulate the mechanisms involved in inflammation and oxidative stress cycle. resveratrol is capable of promoting the activation of the transcription-related factor-2 nuclear factor erythroid factor 2 (nrf2) , a nuclear factor with anti-inflammatory properties, and sirt-1, a protein also associated with the reduction of inflammation. these two factors, in their turn, are able to inhibit / antagonize the activity of the nuclear factor κb (nf-kb), a transcription factor that participates in the inflammatory response. although it is a promising treatment, there are no studies evaluating the effects of resveratrol supplementation in patients with ckd. thus, this study aims to evaluate the effects of resveratrol supplementation on inflammation and oxidative stress in patients undergoing conservative treatment of ckd.


Eligibility criteria:
inclusion criteria: * chronic kidney disease patients in stages 3 or 4, undergoing conservative treatment exclusion criteria: * patients with diabetes mellitus, aids, inflammatory or infectious diseases, pregnant women, smokers and those using antioxidant supplements

Keywords: resveratrol oxidative stress inflammation
cell-based therapy for the treatment of kidney disease

Conditions: Kidney Diseases

Summary: endothelial progenitor cells derived from and delivered to the renal vasculature may be stimulated to initiate differentiation programs during episodes of injury. it is hypothesized that endothelial progenitor cells from the kidney can transition to a phenotype that promotes endothelial repair.

this is an interventional study involving patients that have a diagnosis of chronic kidney disease. patients will have at least stage 3 chronic kidney disease stage or greater. kidney-derived endothelial progenitor cells will have been obtained using associated protocols that are currently approved by the partners human research committee.

Eligibility criteria:
inclusion criteria: * enrolled patients will have endothelial progenitor cells previously acquired. exclusion criteria: * patients without previously acquired endothelial progenitor cells will be excluded.
nemo1:neonatal seizure using medication off-patent

Conditions: Neonatal Seizures

Summary: nemo is a multicentre pan european clinical trial with the aim to develop new treatment strategies for the treatment of neonatal seizures using the loop diuretic bumetanide. there is evidence that bumetanide improves gabaergic function of the current standard drug, phenobarbitone. bumetanide has been used as a diuretic in term and preterm babies for around thirty years. this trial should confirm that bumetanide in addition to standard treatment will result in better seizures control.


Eligibility criteria:
inclusion criteria:- * male or female term baby with gestational age of 37-43 weeks and postnatal age \<48 hours * one or more of the following: * apgar score \< 5 at 5 mins. * umbilical cord or first arterial blood sample ph \ 16 mmol/l. * postnatal resuscitation still required 10 minutes after birth * clinically evolving encephalopathy * received one dose of standard anticonvulsive therapy (phenobarbitone,20mg/kg) for clinical or electrographic seizures. * eeg: equal to or more than 3 min cumulative seizures, or 2 or more seizures of \>30 sec duration over 2 hr period within first 48 hr of life * written informed consent of parent or guardian. * eeg monitoring has commenced within the first 48 hours of birth. exclusion criteria: * suspected or confirmed brain malformation, inborn error of metabolism,genetic syndrome, or major congenial malformation * congenital (in utero) infection (torch). * babies who have received diuretics such as furosemide or bumetanide in routine clinical management within the last 24 hours. * total serum bilirubin \> 15 mg/dl (255 micromol/l) at inclusion. * on any other anticonvulsive medication other than phenobarbitone or bolus of midazolam / pentobarbitone for intubation. * anuria/renal failure defined as serum creatinine \> 200 micromol/l. * severe electrolyte depletion (na \<120 mmol/l, k \<3.0 mmol/l)

Keywords: neonatal seizures hypoxic ischemic encephalopathy electroencephalography bumetanide
a 4-week safety study of oral elnd005 in young adults with down syndrome without dementia

Conditions: Down Syndrome

Summary: this is a prospective, randomized, double-blind, placebo-controlled, parallel-group, three-arm, multicenter study of the safety and pk of elnd005 administered orally for 4 weeks. this study will enroll down syndrome patients 18 to 45 years of age (inclusive) without dementia.


Eligibility criteria:
inclusion criteria: * 18 - 45 years of age * has an iq of \> 40 (k-bit) * able and willing to have a brain mri exclusion criteria: * symptoms of dementia or worsening cognition over the past year. * has a history of hepatitis b, hepatitis c, or hiv
intensive management of at-risk patients

Conditions: Chronic Disease

Summary: the purpose of this study is to assess if intensive management of at-risk participants, utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action planning and careful outcomes monitoring, will lead to better patient outcomes than usual care.

at-risk participants will be randomized 1:1 to either usual care or intensive management utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action planning and careful outcomes monitoring for 6 months. participants in the intervention group will be assigned to a partnership of one nurse practitioner and one medical assistant who will manage them with the support of the study team. staff will focus on contacting all patients within one week of any emergency department visit or hospital discharge, contacting all highest-risk participants weekly and all participants monthly, and completing high-priority tasks for participant care within one week. the primary outcomes of this quality improvement study are inpatient bed days and number of inpatient admissions.

Eligibility criteria:
inclusion criteria: at-risk patients, meaning gold, silver, or bronze tier, as identified by our member 360 platform: * gold tier - 6+ emergency department (ed) visits last year, annual spend \>$100,000, 8 or more hierarchical condition category (hcc) diagnoses, readmission \<30 days prior, or ambulatory care-sensitive condition (acsc) hospitalization \<30 days prior * silver tier - 4+ ed visits last year, annual spend \>$75,000, 6 or more hcc diagnoses, readmission \<90 days prior, substance abuse hcc diagnosis, behavioral health admit \<90 days, 15+ chronic medications prescribed in the last 90 days (and not qualifying for gold tier) * bronze tier - 3+ ed visits last year, annual spend \>$50,000, 5 or more hcc diagnoses, 3+ hospitalizations last year, end-stage liver disease, end-stage renal disease, medicare and medicaid dual-enrolled, disease-management program patients with acsc admission or ed visit in the last year, 10+ chronic medications in the last 90 days, 6+ health risk-assessment score, 12+ edmonton frail scale score (and not qualifying for gold or silver tiers) exclusion criteria: * enrolled in hospice * enrolled in institutional special needs plan * primary patient of study investigator

Keywords: high need high cost population health care management quality improvement ambulatory care primary care readmission prevention
fibrin sealant vh s/d 500 s-apr in hepatic resection

Conditions: Bleeding (Oozing) in Hepatic Resection

Summary: the purpose of the study is to compare safety and efficacy of fibrin sealant (fs) vapor heated (vh) s/d 500 s-apr with manual compression as a supportive treatment of local bleeding (i.e. oozing) in hepatic resection surgery when standard surgical techniques are insufficient.


Eligibility criteria:
pre-operative inclusion criteria: * signed informed consent obtained from the subject before any study-related activities * subject's age is 18 years or above * subject will undergo planned, elective resection of at least 1 anatomical segment of the liver for any reason by laparotomy * subject is willing and able to comply with the requirements of the protocol * female subjects of childbearing potential must present with a negative serum or urine pregnancy test within 72 hours before the elective liver resection * female subjects of childbearing potential must agree to employ adequate birth control measures for the time of their participation in the study intra-operative inclusion criteria (before randomization): * resection of at least 1 anatomical segment of the liver has been performed * oozing from the cut surface of the liver persists after conventional resection procedure and primary control of arterial and venous bleeding by sutures, ligations, clips, vascular stapler, point electrocautery or focal radiofrequency ablation * need for additional supportive hemostatic treatment to stop bleeding (i.e. diffuse oozing) of the liver resection area pre-operative exclusion criteria: * subject needs emergency liver surgery * subject will undergo liver resection via laparoscopic procedure * subject has known congenital coagulation disorder (e.g. hemophilia) * subject has known hypersensitivity to any ingredient of the investigational medicinal product * suspected inability or unwillingness of the subject to comply with trial procedures * if female, subject is pregnant or lactating at the time of study enrollment * subject has already participated in this study (each subject can only be enrolled once) * subject has participated in another clinical study involving an investigational product or investigational device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an investigational product or investigational device during the course of this study intra-operative exclusion criteria (before randomization): * occurrence of any severe surgical complication that require resuscitation or deviation from the planned surgical procedure * disseminated intravascular coagulopathy (dic) * application of any topical hemostatic material on the resection surface of the liver prior to application of the study treatment * radiofrequency precoagulation of the liver resection surface, except focal use of radiofrequency as primary hemostatic treatment
targeted radionuclide therapy for metastatic melanoma [131i] icf01012

Conditions: Melanoma

Summary: this study is a phase i clinical trial aimed to determine the recommended dose of \[131i\]icf01012 to administer for the treatment of patients with pigmented metastatic melanoma (binding \[131i\]icf01012 ). the \[131i\]icf01012 is a targeted radionuclide therapy with a high affinity for melanin.

this study will include a maximum of 36 patients. this study will begin with a preselection part that consists of an injection of \[131i\]icf01012 at a diagnostic dose (185 mbq) in order to preselect patients who will receive the therapeutic dose according to the dosimetry results : binding of \[131i\]icf01012 on at least a tumoral lesion and an acceptable radiation absorbed dose to major organs. the second phase will consist of a therapeutic part with a single administration of \[131i\]icf01012 at a therapeutic dose. this part is a dose escalation model (4 levels of therapeutic dose were tested)

Eligibility criteria:
inclusion criteria: * patient with metastatic melanoma failure to recommended treatments by has. * initial histological diagnosis of cutaneous melanoma pigmented or unknown status or choroidal melanoma. * presence of at least one measurable lesion and / or evaluable in 18fdg-pet as percist criteria. * presence of at least one measurable lesion and / or evaluable as ct recist 1.1 criteria. * who performance index ≤ 2 . * age\&gt; 18 years * life expectancy\&gt; 3 months. * creatinine ≤ 1,5 x uln or creatinine clearance ≥ 60ml/min if creatinine \&gt; 1,5 x uln , neutrophil \&gt; 1,5.109l-1, platellets \&gt; 100 x 109l-1, prothrombine time \&lt; 1,3 x control, hemoglobin \&gt; 9 g/dl, facteur v \&gt; 80% (or ast, alt ≤ 3 x lns (≤ 5 x uln if liver metastasis)). * normal cardiac fonction (lvef\&gt; 40%). exclusion criteria: * brain metastases symptomatic * patient with a vi skin phototype * previous treatment with chemotherapy, radiotherapy, immunotherapy and targeted therapy in the previous 4 weeks, the first injection of \[131i\] icf01012 * pregnant woman, nursing or woman of childbearing age refusing to follow effective contraception during treatment and 12 months after the administration of therapeutic dose. * men refusing to follow effective contraception during treatment and 12 months after the administration of therapeutic dose * other evolutionary known cancer in the past five years * earlier irradiation of more than 25% of the bone marrow * suspicion of invasion of more than 25% of the bone marrow on imaging 18f-fdg pet-ct * external radiotherapy on target organs or the maximum dose as recommended in force * uncontrolled diabetes * known history of allergy to the excipients of the solution of \[131i\]icf01012 * any comorbidity or severe disease at the discretion of the investigator

Keywords: metastatic melanoma targeted radionuclide therapy
autologous micrografts from the palatal mucosa for periodontal regeneration

Conditions: Periodontitis

Summary: some research studies have demonstrated that autologous micrografts made out of different oral tissues may enhance tissue regeneration. the primary aim of this study is to evaluate the clinical performance of a combined approach using an autologous micrograft derived from the palatal mucosa with an alloplastic scaffold for periodontal regeneration of intrabony defects in terms of clinical attachment level gain (primary outcome) and other secondary outcomes (probing pocket depth reduction, radiographic bone fill) compared to a scaffold alone. moreover, this study aims to compare early wound healing and patient-reported outcome measures between the two groups.


Eligibility criteria:
patients selected for the study should fulfil the following inclusion criteria: * affected from stage iii-iv periodontitis. * completed non-surgical periodontal therapy. * fmps \<15% at 3-month re-evaluation. * fmbs \<15% at 3-month re-evaluation. * at least one site with an interproximal intrabony defects and residual ppd ≥ 6 mm at re-evaluation, with a radiographic intrabony component ≥ 3 mm, extending to the lingual/palatal side as assessed by preoperative bone sounding. * intrasurgically, the defect has to present a non-supporting anatomy (1-2 residual walls in its most coronal portion), requiring flap elevation on both buccal and oral side for its accessibility. * signed informed consent. exclusion criteria: * compromised general health which contraindicates the study procedures (asa iii-vi patients). * systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulatory drugs (e.g., cyclosporine), and high-dose oral contraceptives. * current smokers (self-reported), users of chewing tobacco, and drug/alcohol abusers. * pregnant or nursing women. * presence of furcation involvement ≥ ii degree (hamp 1975) at the affected teeth. * very large and wide defects that required the use of membrane.
effects of probiotic ayran on gingivitis

Conditions: Gingivitis; Probiotics; Inflamed Gums

Summary: objectives: this study investigates the effects of daily consumption of probiotic ayran drink on gingival inflammation and the development of experimental gingivitis. methods: a total of 54volunteer students were included in the present randomized, double-blind, placebo-controlled trial.the participants were divided randomly into two groups; the control group consisted of 27 participants who consumed placebo ayran, while the 27 participants of the test group consumed probiotic ayran (containing lactobacillus acidophilus and bifidobacterium bifidum) for 42 days twice a day.after 42 days, mechanical plaque control was interrupted for 5 days. the clinical parameters of gingivitis; plaque index (pi), gingival index (gi), probing bleeding (bop), probing depth (ppd) were recorded at baseline, day 42 (beginning of experimental gingivitis) and day 47 (the end of experimental gingivitis). at the same time points, gingival crevicular fluid had been collected for analysis of matrix metalloproteinase - 8 (mmp-8).

the most used and studied probiotics in the periodontal literature are lactobacillus and bifidobacterium. the current study aims to observe the effects of daily ayran consumption containing a probiotic combination of lactobacillus acidophilus and bifidobacterium bifidum on plaque development and gingival inflammation in an experimental gingivitis model of healthy individuals. the null hypothesis of this study using of probiotics has no additional benefit for periodontal health. this study evaluates the effects of daily consumption of ayran containing a probiotic combination of lactobacillus acidophilus and bifidobacterium bifidum on plaque development and gingival status in healthy individuals with experimental gingivitis.

Eligibility criteria:
inclusion criteria: * systemic healthy * subjects with gingivitis defined as a bop sites ≥ 10% and pd ≤ 3 mm * no radiographic bone loss * non-smoking participants exclusion criteria: * history of using antibiotics or anti-inflammatory drugs or probiotic preparations or food supplements in the last 6 months, * undergoing orthodontic treatment, * active carious lesions * mouth breathing * history of allergy for milk or fermented milk products. * taking medications affecting the gingiva and/or oral mucosa
a pet study with ro5545965 in healthy male volunteers

Conditions: Schizophrenia

Summary: this single center, open-label study will evaluate the pk-pde10a enzyme occupancy relationship of ro5545965 after a single dose in healthy male volunteers by positron emission tomography (pet).


Eligibility criteria:
inclusion criteria: * healthy male subjects, 25 to 50 years of age, inclusive; healthy status is defined by absence of evidence of any active or chronic disease * body mass index (bmi) 18 to 30 kg/m2 inclusive * male subjects with female partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method (i.e. condom), for the duration of the study and for 30 days after the last dose exclusion criteria: * history of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, haematological or allergic disease, metabolic disorder, cancer or cirrhosis * history of clinically significant hypersensitivity or allergic drug reactions * any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse * regular smoker (\> 5 cigarettes, \> 1 pipeful or \> 1 cigar per day) * positive for hepatitis b, hepatitis c, or hiv infection * evidence of significant cardiovascular disease or disorder * participation in an investigational drug or device study within 3 months prior to first administration of the study drug or within 6 times the elimination half-life, whichever is longer * previous inclusion in a research and/or medical protocol or any clinical procedures involving nuclear medicine, pet, occupational exposure to ionizing radiation or radiological investigations with significant exposure to radiation, excluding dental x-ray and common x-rays of chest or extremities * subject has any condition that would prevent an mri from accurately or safely being performed \[eg, claustrophobia, cardiac pacemaker, metallic implants or clips\] * subject unable to lie on his back in the pet or mri scanner for a period of 90 minutes * contraindication for arterial cannulation * unsuitable veins for repeated venipuncture
comparison of mtx+anti-tnf to mtx+conventional dmards in patients with early rheumatoid arthritis (ra) who failed mtx alone (swefot)

Conditions: Rheumatoid Arthritis

Summary: the swefot trial was designed to compare two treatment strategies for patients with early rheumatoid arthritis (less than 1 year symptom duration): the use of a combination of traditional antirheumatic medications (dmards), versus a combination including a newer "biological" anti-tnf medication. in order to make this trial consistent with current practices in rheumatology, all patients were first given the most commonly used antirheumatic medication, methotrexate (mtx). after 3-4 months those patients who had not responded adequately to this treatment were randomized to receive either mtx plus sulfasalazine plus hydroxychloroquine, or mtx plus infliximab. again, to be truly life-like, the trial allowed patients who could not tolerate one of the added medications to switch in treatment - but keeping with the same strategy - so that sulfasalazine plus hydroxychloroquine could be replaced by cyclosporin a, and infliximab by etanercept. the primary outcome in this trial was the percentage of patients who, after one year of treatment, achieved a "good response" as defined by eular.

the swefot trial was designed to compare two treatment strategies for patients with early rheumatoid arthritis (less than 1 year symptom duration): the use of a combination of traditional antirheumatic medications (dmards), versus a combination including a newer "biological" anti-tnf medication. in order to make this trial consistent with current practices in rheumatology, all patients were first given the most commonly used antirheumatic medication, methotrexate (mtx). after 3-4 months those patients who had not responded adequately to this treatment were randomized to receive either mtx plus sulfasalazine plus hydroxychloroquine, or mtx plus infliximab. again, to be truly life-like, the trial allowed patients who could not tolerate one of the added medications to switch in treatment - but keeping with the same strategy - so that sulfasalazine plus hydroxychloroquine could be replaced by cyclosporin a, and infliximab by etanercept. the primary outcome in this trial was the percentage of patients who, after one year of treatment, achieved a "good response" as defined by eular. secondary outcomes include eular and acr responses, haq and other qol assessments, radiographic outcomes, and health-economic outcomes including eq5d.

Eligibility criteria:
inclusion criteria: * ra, symptom duration \< 12 months exclusion criteria: * contraindication to any of the trial medications