Kornimate/medical-research-clean huggingface dataset:
fuzhenghuayu in combination with ursodeoxycholic acid in primary biliary cirrhosis

Conditions: Primary Biliary Cirrhosis

Summary: ursodeoxycholic acid (udca) has been the only treatment for pbc approved by us and european drug administrations. long-term use of udca (13-15 mg/kg/day) in patients with pbc improves serum liver biochemistries and survival free of liver transplantation. however, about 40% of patients do not respond to udca optimally as assessed by known criteria for biochemical response. those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. and udca has less effect on pbc patients whose pathology stage 3-4. liver fibrosis might jeopardize the udca effect. fuzhenghuayu is a chinese traditional medicine for liver fibrosis and cirrhosis. both lab research and some clinical studies suggest that fuzhenghuayu could significantly reverse liver fibrosis and cirrhosis due to different kind of etiology. here the investigators start a random, open and parallel clinical research to explore the effect of fuzhenghuayu combined with udca in the pbc treatment.


Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. patient with pbc defined by 2 in 3 of the following criteria: * positive antimitochondrial antibody type m2; * abnormal serum alkaline phosphatases (alp \> 1,5n) and aminotransferase (ast or alt \> 1n) activities; * histological hepatic injuries consistent with pbc. exclusion criteria: 1. pregnancy or desire of pregnancy. 2. breast-feeding. 3. co-existing liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, biopsy-proven non-alcoholic fatty liver disease, wilson's disease and hemochromatosis. 4. history or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites). 5. history of urolithiasis, nephritis or renal failure (clearance of creatinine \< 60 ml/mn). 6. hepatotoxic drugs use before recruiting. 7. fuzhenghuayu anaphylaxis.

Keywords: fuzhenghuayu
bioequipotency study of idrabiotaparinux and idraparinux in patients with deep venous thrombosis of the lower limbs

Conditions: Deep Venous Thrombosis

Summary: the three purposes of this study are the following: * to compare during a 6-month treatment the safety and effectiveness of idrabiotaparinux (ssr126517) with that of idraparinux (sr34006), taking into account new events of deep venous thrombosis (dvt) and pulmonary embolism (pe), and bleeding risk; * to compare the activities of idrabiotaparinux and idraparinux directly in blood during and after a 6-month treatment; * to check the ability of avidin (ssr29261) to reverse the blood thinning activity of idrabiotaparinux at the end of a 6-month treatment period.

the study consists in a 6-month treatment period followed by an observational period of 3 to 6 months with a month 9 visit and a phone/contact visit at month 12. all participants who complete the 6-month treatment period are re-randomized to either the idrabiotaparinux/idraparinux bioequipotency sub-study or the avidin neutralizing effect sub-study.

Eligibility criteria:
inclusion criteria: * confirmed acute symptomatic dvt of the lower limbs exclusion criteria: * severe concomitant diseases (e.g. renal failure, hepatic failure, uncontrolled hypertension) * active bleeding or high risk for bleeding. * pregnancy or childbearing potential without proper contraceptive measures. * breastfeeding * known allergy to idraparinux, ssr126517e, or egg proteins * indication of prolonged anticoagulation for other reason than dvt of the lower limbs * symptomatic pulmonary embolism (pe) * life expectancy \< 6 months.

Keywords: deep venous thrombosis
study of the acute metabolic effect of exenatide in type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the study is designed as an open labeled pilot trial to analyze the acute responses of glucose, glp-1, gip, insulin secretory,and glucagon to a mixed meal tolerance test (mmtt) or intravenous glucose tolerance tests (ivgtt) with and without pretreatment with exenatide (byetta) 5 mcg sc. the investigators will also test the effects of exenatide on gastric emptying during the mmtt.


Eligibility criteria:
inclusion criteria: * t1d of at least 3 yrs duration. * male or female aged 18-56 years who meets the american diabetes association standard t1dm criteria. * hgba1c\<9% * insulin requirement of \< 0.8 u/kg/d * absence of severe hypoglycemia in the past 6 months * absence of ketoacidosis in the past 6 months * menstruating women must have a negative pregnancy test and be willing to avoid pregnancy during the study period. * signed informed consent.. exclusion criteria: * inability or unwillingness to give informed consent. * prior exenatide or liraglutide treatment or use of any medication that could potentially affect diabetes or immunologic status * known hypersensitivity to exenatide or any product components * participation in an investigational treatment trial within the last 6 weeks before enrollment. * any medical condition that in the opinion of the investigator would interfere with safe completion of the trial such as: epilepsy, atopic disease, active grave's disease, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease, cerebrovascular disease,liver disease, hiv, or any concurrent autoimmune disease except treated and stable thyroid disease * known severe renal impairment, end-stage renal disease or renal transplantation. * any history of gastroparesis or other severe gastrointestinal disease, pancreatitis, thyroid nodules or malignancy with the exclusion of a history of localized basal cell carcinoma. * uncompensated heart failure, fluid overload, myocardial infarction or liver disease within the last 6 weeks before enrollment. * active clinically serious infections. * positive pregnancy test in menstruating women or lactating females
an investigational immuno-therapy study of bms-986205 given in combination with nivolumab and in combination with both nivolumab and ipilimumab in cancers that are advanced or have spread

Conditions: Advanced Cancer; Melanoma; Non-Small Cell Lung Cancer

Summary: the purpose of the study is to determine safety and effectiveness of experimental medication bms-986205 when combined with nivolumab and in combination with both nivolumab and ipilimumab in patients with cancers that are advanced or have spread. pharmacokinetics and pharmacodynamics of bms-986205 when combined with nivolumab and in combination with nivolumab and ipilimumab in this patient population will also be assessed.


Eligibility criteria:
for more information regarding bristol-myers squibb (bms) clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * during dose escalation, subjects with advanced solid tumors that have progressed following at least one standard regimen * during cohort expansion, subjects with advanced cancer that either have received at least one prior therapy or are treatment naive, depending on the specified tumor type * subjects must have measurable disease * subject must consent to provide previously collected tumor tissue and a tumor biopsy during screening. * at least 4 weeks since any previous treatment for cancer * must be able to swallow pills or capsules * eastern cooperative oncology group(ecog) performance status 0-1 exclusion criteria: * active or chronic autoimmune diseases * uncontrolled or significant cardiovascular disease * history of any chronic hepatitis, active hepatitis b or c, human immunodeficiency virus (hiv), or acquired immune deficiency syndrome (aids) * chronic hepatitis: positive test for hepatitis b virus surface antigen or hepatitis c antibody (except for subjects with hepatocellular carcinoma) * active central nervous system (cns) metastases and cns metastases as the only sites of disease * active infection other protocol defined inclusion/exclusion criteria could apply
objective analysis of caesarean scar pregnancy

Conditions: Caesarean Scar Pregnancy; Ultrasound Scoring System

Summary: this study uses a systematic scoring method combined with clinical and ultrasound data to comprehensively evaluate patient conditions and explore the guiding value of the ultrasound quantitative scoring system for selecting the surgical approach for caesarean scar pregnancy.


Eligibility criteria:
inclusion criteria: * history of at least one previous caesarean section * symptoms suggestive of caesarean scar pregnancy, such as unexplained abnormal vaginal bleeding, abdominal pain, cervical pain or abnormal uterine activity during pregnancy * amenorrhea ≤84 days * ultrasound examination suggesting a single gestational sac with intact morphology * stable maternal vital signs exclusion criteria: * mass-type caesarean scar pregnancy * previous medication or surgical treatment before ultrasound examination * haemodynamically unstable patients * patients with surgical contraindications * incomplete or lost follow-up clinical data * patients with severe medical conditions such as hypertension, diabetes, hyperthyroidism and haemophilia
open label study of long term treatment of pediatric treatment of atopic dermatitis with pimecrolimus cream 1% within a usual clinical setting

Conditions: Atopic Dermatitis

Summary: an open-label, multicenter study, of long term management to evaluate effectiveness, tolerability and safety of pimecrolimus cream 1% in pediatric patients with mild to moderate atopic dermatitis in a daily practice


Eligibility criteria:
inclusion criteria: * age ≥ 3 months to 12 years old * clinical diagnosis of atopic dermatitis * history of mild to moderate atopic dermatitis * investigator global assessment ≥ 1 (almost clear/clear of disease) * written informed consent exclusion criteria: * investigator global assessment ≥ 4 (severe/very severe disease) * patients with active skin viral infections (i.e, herpes simplex, herpes zoster, varicella) * patients with atopic dermatitis, with active clinical infection on area of disease. all active infections must be treated prior to trial inclusion * patients in an immunosuppressive state or with history of malignant disease * patients with clinical conditions other that atopic dermatitis that according to the investigator may interfere with the evaluation (i.e, psoriasis, netherton syndrome) * other protocol-defined inclusion/exclusion criteria may apply

Keywords: atopic dermatitis, pimecrolimus, children
study to evaluate the replacement of reverse transcriptase nucleoside/nucleotide inhibitors by nevirapine in patients on triple treatment with analogues only

Conditions: HIV Infections

Summary: the purpose of this study is to evaluate the proportion of patients with viral load of hiv-1 \< 50 copies after 48 weeks of follow-up after randomization to change or not to nevirapine.

rtni (reverse transcriptase nucleoside inhibitors) are a regular part of most antiretroviral combinations. the presence of a smaller or greater degree of cross resistance among all rtni is increasingly better described and acknowledged, whereby the number of salvage regimens that may be built following the appearance of this resistance to these drugs is by no means unlimited. this proactive treatment change in patients on rtni-based regimens while the viral load is still suppressed would avoid the selective replication period under antiviral pressure following the failure of the regimen in which resistance-associated mutations accumulate. this therapeutic approach has demonstrated its effectiveness in clinical practice, albeit not in this scenario. if we wait until the viral load is detectable there is sufficient evidence that resistance to rtni will appear and that this resistance will compromise future salvage options. to intensify with this proactive approach these combinations based on n/nnrti (nucleotide analog), the nnrti are an optimal alternative.there is vast experience with nvp in simplification/maintenance trials. in direct comparative simplification studies in patients with virological response, the response rates with nvp or efv have shown no differences. with a relative risk (rr) of virological failure of 0.54 with regard to the continuation of pi (protease inhibitors), nvp is one of the best simplification treatment options in hiv-1-infected patients.

Eligibility criteria:
inclusion criteria: * patients on triple treatment with 3 nucleoside analogues or transcriptase nucleotide inhibitors in virological suppression. * age \>= 18 years. * confirmed diagnosis of hiv-1 infection. * viral load \< 50 copies/ml over the previous six months, including at least two consecutive determinations. * value of alt transaminase £ 2.5 times the normal value of the laboratory of each centre. * acceptance and signature of the informed consent form. exclusion criteria: * pregnant women or those who intend to become pregnant in the study period. * having had an active infection in the previous month. * previous exposure to any reverse transcriptase non-nucleoside inhibitor (nevirapine, efavirenz or delavirdine). * simultaneous treatment with methadone. * patients with serious hepatic dysfunction

Keywords: nevirapine antiretroviral treatment triple nucleoside therapy hiv treatment experienced
nephrologic prognosis 10 years after diabetes cell therapy

Conditions: Islet Transplantation

Summary: islet transplantation for type 1 diabetes results are still improving, and actually insulin-independence with normal hba1c is obtained in 50% of patients after 5 years, 80% of c-peptide positive patients. in addition to the need of 2 or 3 surgical or radiological interventions to inject islets, an immunosuppressive regimen is needed, which can be deleterious, particularly on kidneys. moreover, long term beneficial effects of islet transplantation on stabilization or prevention of macro and micro vascular complications of diabetes has not been evaluated. in a preliminary work, it was observed a stabilisation or improvement of microvascular complications when compared to pre-transplant data. the aim of this study is to compare the evolution of diabetes complications, especially nephrologic, 10 years after islet transplantation and to compare it to patients with a brittle diabetes, 10 years after evaluation for islet transplantation, finally not performed. this case-control study will evaluate nephrologic parameters (creatinine, mdrd creatinine clearance, microalbuminuria, proteinuria) and other micro and macro-vascular complications of type 1 diabetes) before islet transplantation and 10 years after the transplantation or after the first evaluation in patients who finally did not underwent islet transplantation for various non nephrologic reasons


Eligibility criteria:
inclusion criteria: * type 1 diabetic patients, with or without previous renal transplantation who benefit at least 5 years before the inclusion of clinical evaluation in order to perform an islet transplantation * who either benefit of islet transplantation or did not and treated with optimized insulin therapy exclusion criteria: * c-peptide positive diabetes * type 1 diabetic patient non-grafted of islets due to albuminuria\> 300mg / 24h or mdrd \<50 ml / min during the pre-transplant evaluation (exclusion criterion for islet transplantation) * patients that can not receive clear information * refusal to sign the consent * psychiatric pathology * participation in another study excluding the possibility of participating in another protocol. * pregnant or breast feeding women * patients under guardianship, persons deprived of freedom * lack of coverage by the social security system
study to evaluate safety and effectiveness of advacoat sinus gel

Conditions: Ethmoid Sinusitis; Rhinosinusitis

Summary: the purpose of this study is to evaluate the safety and effectiveness of advacoat® sinus gel, a nasal/sinus dressing, for adhesion prevention following endoscopic ethmoid sinus surgery. subjects were randomized to receive advacoat applied to the right or left middle meatus tissues and merogel applied to the middle meatus tissues on the opposite side.

chronic rhinosinusitis is a very common condition, affecting 35 million americans each year. all paranasal sinuses need ventilation to prevent infection and inflammation. sinus ventilation occurs through the ostia into the nose. when rhinosinusitis occurs, the mucous membranes of the sinuses become swollen, resulting in ostia closure. functional endoscopic sinus surgery (fess) is a minimally invasive surgical procedure that opens the sinus ostia. the most common unwanted side effect of the fess procedure is the formation of adhesions (fibrous bands) in the area of surgery. these bands (adhesions) can prevent proper ventilation and drainage from the paranasal sinuses. various hyaluronan based biomaterials are now available and in common use to provide a post-surgical nasal dressing which is absorbable, can prevent adhesion formation, and eliminate the pain and tissue abrasion caused by removal of non-absorbable nasal packing. advacoat is a bioresorbable hyaluronan gel that conforms to mucosal surfaces and provides a post-surgical nasal dressing to prevent adhesion formation as tissues heal.

Eligibility criteria:
inclusion criteria: patients who: 1. have bilateral chronic rhinosinusitis confirmed by physical exam, clinical history, and prior radiography 2. have bilateral ethmoid sinus disease 3. are scheduled for bilateral anterior or total ethmoidectomy exclusion criteria: 1. unilateral ethmoid sinus disease 2. partial resection of middle turbinates, unilateral or bilateral

Keywords: rhinosinusitis, ethmoid
online mindfulness-based cognitive therapy for parents of children with food allergies

Conditions: The Quality of Life of Parents of Children With Food Allergy

Summary: this study aims to conduct an initial evaluation of adapted, live online, mindfulness-based cognitive therapy for parents and carers of children with food allergies (mbct-pccfa).

this study is a pilot randomised controlled trial (rct) comparing adapted, live online, mindfulness-based cognitive therapy for parents and carers of children with food allergies (mbct-pccfa) with a treatment as usual control. a battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 15) and at follow-up (week 23).

Eligibility criteria:
inclusion criteria: * parents or caregivers who identify as having a child under the age of 18 with a food allergy * the allergy has been diagnosed by a qualified physician (e.g. gp or allergy specialist) * mean score of \>=2 on the faql-pb, indicating they are at least 'somewhat limited/troubled' by their child's allergy (cohen et al., 2004). * resident in the united kingdom * have access to email, a pc/laptop/tablet with a webcam and microphone and internet access to allow videoconferencing exclusion criteria: * they had consulted on the design and content of the intervention or study * they have already participated in a substantial mindfulness-based course * they are currently engaged or are planning to engage with another psychological intervention during the course of the study * they currently engage in regular mindfulness-based practice * they do not have the practical means and time available to be able to attend the intervention during the dates outlined on the information sheet and commit to at-home practice * they have scores \>19 on phq-8 (indicating 'severe' depressive symptom severity; kroenke et al., 2009) or \>15 on gad (indicating 'severe' level of anxiety; spitzer et al., 2006) * they have a problem with alcohol or recreational drug misuse * they have experienced thoughts about harming themselves or others in the last 12 months * they have been given a diagnosis of psychosis * they are currently experiencing high levels of distress and/or currently feeling particularly fragile * they have experienced a bereavement of someone close to them in the last year or are continuing to experience continuing grief in relation to losing someone further back in time * they have had traumatic experiences that they continue to be troubled by (including, but not limited to, receiving diagnosis of post-traumatic stress disorder) * they experience significant difficulty being in a group with other people. nb: for further details re the faql-pb and phq-8, please see the outcome measures section.
long term follow up of chronic hcv patients receiving daas

Conditions: Chronic Hepatitis c

Summary: follow up of chronic hepatitis c patients with moderate to severe fibrosis and cirrhosis treated with direct acting antivirals after sustained virological response for 4-5 years to detect changes in hepatic fibrosis and liver functions.

treatment of chronic hepatitis c is evolving rapidly. three classes of direct-acting antiviral agents, including inhibitors of the hcv ns3/4a protease, ns5b polymerase, and ns5a have been approved for the treatment of patients with chronic hepatitis c, both in combination with pegylated interferon (peg-ifn) / ribavirin (rbv) and, recently, in interferon-free combination. the objective of chronic hepatitis c treatment is to achieve svr which is defined as the absence of viral replication at 12 or 24 weeks after treatment completion. svr reduces morbidity and mortality and is equivalent in most cases to cure the hcv infection. studies have demonstrated that svr is associated with histological improvement, assessed by liver biopsy, and with the prevention of complications, such as the development of liver cirrhosis and hcc.

Eligibility criteria:
inclusion criteria: * chronic hcv patients with moderate to severe hepatic fibrosis (f2: f4) or cirrhosis who received direct-acting antivirals and achieved svr. exclusion criteria: * other liver diseases as chronic hepatitis b and autoimmune liver disease. hiv co-infection.