Kornimate/medical-research-clean huggingface dataset:
advanced glycation products and vascular complications in type 1 diabetes

Conditions: Type1diabetes

Summary: diabage (diabetes advanced glycation end products) study was conducted between 2015 and 2017. it included 196 type 1 diabetic patients with more than 10 years of diabetes. it revealed a significant association between the occurrence of vascular complications and tissular advanced glycation end products (ages) as well as with some circulating ages. this protocol is a continuation of that initial research.

the objective is to evaluate in patients included in the diabage study the incident vascular events (micro and macroangiopathic) after at least 5 years of follow-up. the secondary objectives are: 1. to assess the predictive value of the initial measurement of ages (advanced glycation end products) on the occurrence of these complications. 2. to study the correlation between tissue ages measured after 5 years of evolution and hba1c values between the first inclusion and this new evaluation. material and methods: experimental design: monocentric observational study (reims university hospital). population/patients: patients included in the diabage study are regularly followed in the endocrinology, diabetology, nutrition department of the reims university hospital. investigation plan: * all patients in the diabage study will be invited to participate. the estimated participation rate is between 80 and 90%. * the explorations will be carried out as part of their usual follow-up during a short hospitalization (day or week hospital, depending on the patient). a careful clinical examination will be conducted, as well as a biological check-up. if necessary, investigations for chronic complications will be carried out, including a fundus, systolic pressure indexes, an electrocardiogram and, if necessary, an evaluation of the coronary artery calcium score. skin auto-fluorescence will also be measured using the age-reader (available at the university hospital). judgement criteria: primary endpoint: measurement of the incidence of micro and macro angiopathic vascular complications occurring during the follow-up of type 1 diabetic patients in the diabage cohort. secondary endpoints: * measurement of initial circulating and tissue ages. * measurement of tissue age delta, defined as the difference between age after at least 5 years and baseline age. * repeat measurements of hba1c over the follow-up period.

Eligibility criteria:
inclusion criteria: * inclusion in initial diabage study. * follow-up at reims hospital. exclusion criteria: - refusal to participate.

Keywords: vascular complication diabetic retinopathy diabetic nephropathy diabetic neuropathy cardio-vascular events advanced glycation end products age
clinical outcome in uveitis

Conditions: Uveitis

Summary: this study is aimed at investigating the long term clinical outcome of patients with uveitis.

patients will be included if they are treated for uveitis and have had repeat follow-up. data will be gathered from the entire length of the patients follow-up. the main outcome measures will be: change from baseline of best corrected visual acuity (bcva)at 10 years causes of vision loss (≤6/15, vl) and severe vision loss (≤6/60, svl) at 10 years number of clinical visits at 10 years.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of uveitis. exclusion criteria: * no follow-up data.

Keywords: uveitis vision loss
adjunctive use of dermal matrix to compensate dimensional changes in the reconstructive therapy of peri-implantitis

Conditions: Peri-Implantitis

Summary: one critical element regarded to successfully resolve peri-implantitis is to efficiently decontaminate the contaminated implant surface. mechanical, pharmacological and chemical strategies have been proposed to eliminate bacterial plaque and remnants from the implant surface. however, evidence has not demonstrated superiority of a given detoxification agent/strategy. recently, the electrolytic approach has been indicated for the surgical detoxification in the management of peri-implantitis. for the electrolytic approach (ea) the implant has to be loaded negatively with a voltage and a maximum current of 600 ma. this is achieved by a device (gs1000, galvosurge dental ag, widnau, switzerland) providing the voltage and pumping a sodium formiate solution through a spray-head, which has to be pressed into the implant by finger pressure to achieve an electrical contact. another critical aspect in the management of peri-implantitis is related to the esthetic sequelae associated with disease resolution. sanz-martin et al. in a systematic review demonstrated that reconstructive therapy is less prone to exhibit mucosal recession when compared to resective therapy. nonetheless, it seems to be unavoidable no matter the surgical intervention. aiming at attenuating these changes, schwarz et al. noted that the adjunctive use of connective tissue grafts may enhance the height of the mucosal level, which in turn may impact upon the esthetic outcome. therefore, the research question is the following: what is the clinical, radiographic and 3d volumetric effectiveness of dermal matrix to improve the outcome of reconstructive therapy of peri-implantitis-related bone defects? the study is to be performed in two centers: center of implantology, oral and maxillofacial in badajoz (spain) and clinical periocentrum ortiz-vigon in bilbao (spain)


Eligibility criteria:
inclusion criteria: * diagnosed with peri-implantitis-related intrabony defects * all subjects had dental implants with screw-retained or cement-retained fixed or removable implant-supported prosthesis for a minimum of 36 months. * all patients in age of 18 to 80, non-smokers * with no presence of systemic disease or medication known to alter bone metabolism, and partial or complete edentulous patients that have no active periodontal disease. exclusion criteria: * peri-implantitis-related supra-crystal or combined defects * pregnancy or lactation * history of or current smokers * uncontrolled medical conditions, * cement-retained restorations, * lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites.
impact of the ultrasound-guided approach on the efficiency and safety of the stellate ganglion block in chronic pain

Conditions: Complex Regional Pain Syndromes

Summary: the first purpose of this study is to compare the effectiveness of the stellate ganglion block realized with two different approaches (blind and ultrasound-guided) in patients with a diagnosis of complex regional pain syndrome. the second purpose of this study is to determine the safest approach and to compare the safety profiles of the two approaches.

to evaluate whether the ultrasound guided approach is more effective than the blind technique in producing a greater than 1.5 degree celsius rise in ipsilateral arm temperature after a stellate ganglion block. blocks will both be performed with 10 ml of xylocaine/bupivacaine. secondary outcomes will be the impact of the approach (blind vs ultrasound) on pain reduction, horner syndrome, side effects (hoarseness, dysphagia, pharyngeal discomfort) and complications (blood aspiration, intravascular injection).

Eligibility criteria:
inclusion criteria: * patients aged 18 to 80 years * patients with a new or known diagnosis of complex regional pain syndrome (according to the criteria of budapest) at the upper extremity exclusion criteria: * refusal of a patient * coagulopathy * systemic infection or local infection at the needle injection site * major deformation at the level of the neck (radiotherapy, surgery, etc. ) * concomitant chronic pain syndrome * post-pneumonectomy on the controlateral side * severe hepatic impairment or severe renal impairment (clcr under 30 ml/min) * known allergy to local anesthetics of amide type * inability to understand a numeric pain scale
effect of the consumption of an enriched surimi in abdominal visceral adiposity

Conditions: Obesity, Abdominal

Summary: the finding that the combination of the inactivated probiotic bifidobacterium lactis (bpl1), inulin as a source of soluble fiber and omega-3 fatty acids, eicosapentaenoic acid (epa) and docosahexaenoic acid (dha), in a surimi matrix has positive effects on visceral adiposity , insulin resistance and plasma tryclycerides in a preclinical model of rats that present obesity induced by diet is the basis of the present hypothesis. this finding is based on the fact that these three bioactive compounds exert these effects through sensibly different and complementary mechanisms, which suggests that their combined use may have synergistic effects. on this basis the present hypothesis is posed: the consumption of surimi enriched with inactivated probiotic bpl1, inulin and omega-3 fatty acids, in the same doses that have been effective in obese rats (siap), can induce a reduction of more than 5% of visceral adipose tissue, being clinically relevant in people with abdominal obesity. if the effect on abdominal obesity is associated or not with a lower glycemia and / or absorption of fats induced by the consumption of surimi can be evaluated by monitoring these parameters for 4 hours after the ingestion of a breakfast high in fat. the main objective of this study was to evaluate the effects of the consumption of surimi enriched with the probiotic bpl1, inulin and omega-3 fatty acids, on visceral abdominal adiposity in people with abdominal obesity.


Eligibility criteria:
inclusion criteria: 1. men and women over 18 years of age with a waist circumference ≥102 cm in men and ≥88 cm in women. 2. sign the informed consent. exclusion criteria: 1. having any condition incompatible with nuclear magnetic resonance (rnm) tests, such as metallic implants or sensitive to magnetic fields, pacemakers or suffering from claustrophobia. 2. having diabetes (glucose ≥ 126 mg / dl). 3. bmi values ≥ 40 kg / m2 4. waist circumference\> 150 cm. 5. present dyslipidemia (ldl cholesterol ≥ 189 mg / dl and / or triglycerides ≥ 350 mg / dl). 6. take supplements or multivitamin supplements or phytotherapeutic products that interfere with the treatment under study. 7. present chronic alcoholism. 8. present some chronic gastrointestinal disease. 9. present intolerances and / or food allergies related to the study product. 10. presenting anemia (hemoglobin ≤13 g / dl in men and ≤12 g / dl in women) 11. present some chronic disease in clinical manifestation. 12. being pregnant or intending to become pregnant. 13. be in breastfeeding period. 14. participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study. 15. follow a hypocaloric diet and / or pharmacological treatment for weight loss. 16. suffer eating disorders. 17. being unable to follow the study guidelines.

Keywords: probiotics visceral fat abdominal obesity
effect of chewing gum on controlling nausea/vomiting and thirst in patients with acute pancreatitis

Conditions: Acute Pancreatitis; Thirst

Summary: nausea and vomiting are one of the most common symptoms in acute pancreatitis. in addition to pharmacological methods for nausea and vomiting, non-pharmacological methods can also be used. among these, anticipatory nausea and vomiting can be prevented by behaviors aimed at distracting attention. this study will be conducted to evaluate the effect of chewing gum on the severity of nausea-vomiting and thirst in patients with acute pancreatitis. the study will be conducted with a total of 60 patients, 30 intervention and 30 control. patients in the intervention group will chew xylitol gum five times a day for three days. the patients' thirst and nausea and vomiting conditions will be examined.


Eligibility criteria:
inclusion criteria: * those diagnosed with acute pancreatitis, * without total dental prosthesis, * without salivary gland infection, * those who have not had salivary gland surgery, * no difficulty in chewing, * not receiving oxygen therapy, * able to answer all questions and be communicativ exclusion criteria: * those with diabetes, * does not like chewing gum, * receiving radiotherapy or chemotherapy,

Keywords: acute pancreatitis thirst nouse vomiting
metformin plus sorafenib for advanced hcc

Conditions: Hepatocellular Carcinoma

Summary: metformin is a widely used oral drug for type 2 diabetes and its antitumor effects have got much more attentions recently. it has been shown that metformin exerts anti-cancer activities in several cancers, including primary liver cancer. in this phase ii study, safety and efficacy of the combination of metformin and sorafenib will be evaluated in patients with advanced hepatocellular carcinoma.

sorafenib is the standard choice for advanced hepatocellular carcinoma (bclc-c), but the efficacy is not satisfied. metformin is a widely used oral drug for type 2 diabetes and its antitumor effects have got much more attentions recently. it has been shown that metformin exerts anti-cancer activities in several cancers, including primary liver cancer. recent studies suggest that metformin treatment can reduce the risk of hcc in patients with type 2 diabetes and inhibit hcc invasion and increase drug sensitivity to sorafenib, however, the safety and efficacy of combined therapy for advanced hepatocellular carcinoma remains unclear. in this phase ii study, patients with advanced hepatocellular carcinoma, measurable disease, and an eastern cooperative oncology group performance score≤1 will be enrolled. eligible subjects will be randomly assigned to receive the treatment of sorafenib or metformin plus sorafenib. the potential improvement of overall survival, time to progression and safety will be evaluated.

Eligibility criteria:
inclusion criteria: 1. ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document 2. confirmed hepatocellular carcinoma according to one of following three criteria: histopathology,two radiographic techniques (us, mri, ct, or angiography) that confirm lesion with typical arterial hypervascularization,barcelona clinical liver cancer staging c (bclc-c) 3. age \> 18 years old 4. patients with liver disease classified as child pugh class a 5. eastern clinical oncology group (ecog) performance status 0，1 or 2 (appendix i) 6. hemoglobin ≥ 9 g/dl 7. absolute neutrophil count（anc）≥ 1,500 /mm3 8. platelet count≥ 50,000 /ul 9. total bilirubin \< 2 mg/dl 10. transaminases (sgot and sgpt) no more than 5 times the upper limit of normal 11. alkaline phosphatase \< 4 times the upper limit of normal 12. both men and women and members of all races and ethnic groups are eligible for this study 13. prothrombin time \> 50% 或 pt-inr \< 2.3 exclusion criteria: 1. child pugh score is 7 with ascites 2. severe cardiovascular disease 3. uncontrollable hypertension 4. history of hiv infection 5. active clinical severe infection（\>grade 2 ，nci-ctcae version3.0） 6. women who are pregnant 7. administration of any systemic chemotherapy within the last 6 months 8. presence of history of gastrointestinal bleeding before randomization 9. epileptic seizures requiring drug therapy 10. history of allograft transplantation 11. patients with signs of bleeding or medical history 12. patients undergoing kidney dialysis 13. metastatic liver cancer 14. uncontrollable ascites 15. encephalopathy
sildenafil citrate in frozen embryo transfer

Conditions: Infertility

Summary: comparison between usage of sildenafil citrate with estradiol valerate or estradiol valerate alone in endometrial preparation and outcome of frozen-thawed embryo transfer cycles.


Eligibility criteria:
inclusion criteria: * all cases have at least 2 good quality blastocysts available for transfer exclusion criteria: * uterine structural abnormalities * advanced uterine disease * hydrosalpinx and pyosalpinx

Keywords: ivf
subcutaneous immunoglobulin treatment for multifocal motor neuropathy

Conditions: Multifocal Motor Neuropathy

Summary: the purpose of this study is to evaluate the effect of subcutaneous administration of immunoglobulin compared to intravenous treatment, for multifocal motor neuropathy nb. only recruiting from denmark

introduction intravenous immunoglobulin (ivig) treatment is the only established treatment modality in multifocal motor neuropathy (mmn). in order to maintain neuromuscular performance patients require lifelong treatment. hospital-based treatments have high cost and inconveniences to patients, particularly in chronic disorders. immunoglobulin preparations are now available for subcutaneous use as igg replacement therapy. the safety and efficacy of subcutaneous infusion is reported to be comparable to i.v. preparations, and has been applied successfully in other autoimmune disorders. however patients with mmn have not previously been treated with subcutaneous immunoglobulin. hypothesis: subcutaneous immunoglobulin treatment is efficacious and safe with less patient inconvenience. primary endpoint: isokinetic muscle strength at the end of treatment a vs b (subcutaneous vs i.v.) secondary endpoint: medical research council score (mrc-score), 9-hole peg test, 10m walking, nerve conduction parameters, sf-36.

Eligibility criteria:
inclusion criteria: - clinical diagnosis of multifocal motor neuropathy, supported by electrophysiological findings exclusion criteria: * other severe medical conditions * pregnancy and lactation * anti-coagulation therapy

Keywords: multifocal motor neuropathy subcutaneous ivig gammaglobulin
evaluation of be1116 in patients with traumatic injury and acute major bleeding to improve survival ( tap study )

Conditions: Traumatic Injury

Summary: this is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, large simple trial to investigate the efficacy and safety of a single intravenous (iv) infusion of be1116 in subjects who have traumatic injury, with confirmed or suspected acute major bleeding and / or predicted to receive a large volume blood product transfusion.


Eligibility criteria:
inclusion criteria: * (a) estimated age ≥ 15 years. older minimum age is required in some locations. for united kingdom: estimated or actual age ≥ 16 years for australia: estimated or actual age ≥ 18 years and (b) estimated or actual weight ≥ 50 kg (110 lbs). * traumatic injury with confirmed or suspected acute major bleeding and/or revised assessment of bleeding and transfusion (rabt) score ≥ 2 * activation of massive transfusion protocol exclusion criteria: * healthcare professional cardiopulmonary resuscitation including chest compressions for ≥ 5 consecutive minutes at any time before randomization * isolated penetrating or blunt cranial injury, or exposed brain matter * isolated burns estimated to be \> 20% total body surface area or suspected inhalational injury * known anticoagulation treatment or a history of a tee, within the past 3 months.
post approval study of the remedē system

Conditions: Central Sleep Apnea

Summary: prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē system.

this post approval study is a multi-center, prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē system from the remedē system pivotal trial. only subjects who were implanted and actively being followed as part of the remedē system pivotal trial are eligible. an individual subject's participation is expected to continue to five years post remedē system implant.

Eligibility criteria:
inclusion criteria: * subjects who were previously implanted with the remedē system and participated in the remedē system pivotal trial * in the investigator's opinion, willing and able to comply with all study requirements * signed institutional review board (irb)/independent ethics committee (iec) approved informed consent (including health insurance portability and accountability act \[hipaa\] authorization in the us) exclusion criteria: * there are no criteria by which a subject would be excluded
a retrospective study of toxicity and outcome of high dose chemotherapy with autologous stem cell transplant in patients with non-hodgkin lymphoma (nhl).

Conditions: Non-Hodgkins Lymphoma

Summary: patients with aggressive non-hodgkin-lymphoma treated at first diagnosis with chemotherapy alone or combined chemo-radiotherapy can achieve high response rates. however, patients with relapsed lymphoma still have a poor prognosis. high dose chemotherapy (hdct) followed by autologous stem cell transplantation (asct) is the treatment of choice for these patients. an asct allows patients to receive much higher doses of chemotherapy than usual, to improve the chances of curing the disease. the high-dose of chemotherapy destroys the cells in the patients bone marrow and then the patients own cells from either the bone marrow or peripheral blood are used to rescue the patient from intensive treatment. high-dose chemotherapy with autologous stem cell (either bone marrow or peripheral blood) transplantation is used in the treatment of intermediate/high grade nhl with poor risk disease and in second remission at the royal marsden hospital. the purpose of the present analysis is to determine independent prognostic factors correlated with the long-term outcome of patients with nhl who received an asct between january 1991 and june 2005. accrual of eligible patients currently under follow-up will be performed in clinic at the time of next appointment. all patients accrued will give informed consent to participate in the study for retrospective case note review, after discussion with a study investigator and after receiving a study information sheet. the results of the analysis will be published in a peer-reviewed medical journal. this will include patients treated at the royal marsden hospital only.


Eligibility criteria:
inclusion criteria: - a) age over 18 b) patients with non-hodgkin's lymphoma who have received an autologous stem cell transplant in the past. c) informed written consent exclusion criteria: * a) medical or psychiatric conditions that compromise the patient's ability to give informed consent b) hiv positive or aids related lymphoma
topical 5% imiquimod cream for vulvar paget's disease

Conditions: Paget Disease, Extramammary

Summary: the purpose of this study is to evaluate the efficacy, safety and immunological response of topical 5% imiquimod cream for non-invasive vulvar paget's disease.

vulvar paget's disease is a rare skin tumour and generally seen in postmenopausal, caucasian women as an erythematous, eczematous, scaling or ulcerating plaque. initial symptoms are irritation, burning, pain and a skin lesion. the origin of vulvar paget's disease is not yet entirely understood. the treatment of choice is surgical excision, despite high recurrence rates. the mutilating consequences of surgery can lead to impressive morbidity to address this, several series report the use of topical 5% imiquimod cream for vulvar paget's disease. the objective of this study is to assess the efficacy, evaluate the safety, immunological effect of topical 5% imiquimod cream for vulvar paget's disease and the quality of life during treatment.

Eligibility criteria:
inclusion criteria: * non-invasive vulvar paget's disease, primary or recurrence after earlier surgery; * willing and able to comply with the protocol and to provide informed consent in accordance with institutional and regulatory guidelines. exclusion criteria: * invasive vulvar paget's disease; * underlying adenocarcinoma; * treatment of the vulva with topical 5% imiquimod cream during the last 6 months; * participation in a study with another investigational product within 30 days prior to enrolment in this study; * hypersensitivity to any component of topical 5% imiquimod cream (methylhydroxybenzoate (e218), propylhydroxybenzoate (e216), cetylalcohol, atearylalcohol); * patients with autoimmune disorders; * immune compromised patients (e.g. hiv patients, patients with a history of transplantation); * insufficient understanding of the dutch or english language; * pregnant women; * lactating women.

Keywords: extramammary paget's disease vulva genital, female imiquimod