Kornimate/medical-research-clean huggingface dataset:
biotronik dynetic-35 stent for the treatment of peripheral iliac lesions

Conditions: Peripheral Artery Disease

Summary: biotronik cobalt chromium balloon-expandable dynetic-35 stent in association with passeo-35 xeo peripheral dilation catheter for the treatment of peripheral iliac lesions

prospective, international, multi-center, single-arm study with up to 60 months follow up to evaluate safety and effectiveness of biotronik's dynetic-35 stent associated with the use of passeo-35 xeo for the treatment of peripheral artery disease (pad) in subjects with atherosclerotic disease in iliac arteries

Eligibility criteria:
inclusion criteria 1. subject is ≥ 18 years or the minimum age required for legal adult consent in the country of enrolment 2. subject is capable (no legally authorized representative allowed) to provide written informed consent as approved by the institutional review board (irb)/ethics committee (ec) of the respective clinical site prior to any study related procedure 3. subject has provided written informed consent before any study specific test or procedure and is willing to comply with all protocol and follow-up requirements 4. de novo, restenotic or occluded lesion(s) representing atherosclerotic lesion(s) in the iliac arteries 5. reference lumen (vessel) diameter between 5mm and 10mm 6. the target lesion can be successfully crossed with a guide wire 7. the target lesion length is ≤ 100 mm 8. subjects has more than 70% stenosis in target lesion 9. subject has an evidence of a patent profunda femoris or superficial femoral artery in the target limb 10. subject has symptomatic iliac artery occlusive disease defined as rutherford category 2 or higher eligible for stenting exclusion criteria 1. subject is pregnant and/or breastfeeding or planning to become pregnant during the course of the study. 2. subject is with a current medical condition with a life expectancy of less than one year. 3. pre-existing target iliac artery aneurysm or perforation or dissection 4. any medical condition that in the opinion of the investigator poses an unacceptable risk for implant of a stent according to the study indications like, sensitivity to metal ions, intolerance to contrast or antiplatelet, anticoagulant or thrombolytic medications required per the protocol 5. abdominal aortic aneurysm (aaa) contiguous to the iliac artery target lesion requiring treatment 6. the subject is currently participating in an investigational drug, biologic, or another device study and has not reached their primary endpoint yet 7. refuses blood transfusion 8. chronic renal insufficiency (serum creatinine \>2.5 mg/dl within 30 days prior to index procedure) 9. subject has ifu listed contraindication(s) 10. subject has in-stent restenosis

Keywords: iliac arteries
high fat diet: oxidative and cardiovascular effects

Conditions: Obesity

Summary: to test the effects of a modified atkins high fat diet on endothelial function, insulin resistance and energy balance.

to test the effects of a modified atkins high fat diet on endothelial function, insulin resistance and energy balance.

Eligibility criteria:
inclusion criteria: * bmi 30-39.9 * female * age 21-40 exclusion criteria: * smoker * comorbid disease
mitochondrial cocktail for gulf war illness

Conditions: Gulf War Syndrome; Persian Gulf Syndrome; Mitochondrial Disorders

Summary: the purpose of this study is to develop preliminary evidence, such as effect size and variance estimates, to guide successful conduct of a properly-powered clinical trial to assess the benefit of a mitochondrial cocktail (incorporating individualization of treatment) in gulf war illness (gwi).

see below.

Eligibility criteria:
inclusion criteria: * meet symptom criteria for gulf war illness with both the centers for disease control and prevention (cdc) criteria (persistent symptoms in at least 2 of 3 designated symptom domains of fatigue/sleep, mood/cognition, and musculoskeletal) and kansas criteria (score a moderate or severe rating in at least 3 of the 6 symptom domains of fatigue, pain, neurological/cognitive/mood, skin, gi and respiratory). exclusion criteria: * have conditions like multiple sclerosis or lupus that can produce similar symptoms and be confused for gulf war illness. * participating in a concurrent treatment trial. * unwilling or unable to comply with the treatment protocol * failed run-in; do not take at least 80% of run-in medications
investigation of polymorphisms in bronchopulmonary dysplasia in turkish population

Conditions: Bronchopulmonary Displasia

Summary: bronchopulmonary dysplasia (bpd) is a chronic lung disease that affects a ratio of up to 20-30% of infants prematurely born before 30rd week. delay of starting to speak, cerebral palsy and cognitive disorders may be seen in infants suffering from this disease. although all the evidence found on the specific mediators and pathways that regulate the mechanism by studies made to understand the pathophysiologic mechanism, there hasn't been any remarkable progress on preventing the development of bpd in new-born infants born below 1500gr body weight. bpd is still one of the most important morbidity and mortality reasons in premature infants. there is a need of further studies to understand the genetic background of bpd specific to different populations, to identify polymorphisms related with the disease and for developing genetic methods for early the diagnose of the disease. with this purpose, first of all polymorphisms related with bpd and those which are related with similar other lung diseases will be investigated. dna samples derived from blood samples of 200 patients (100 bpd infant and 100 control) will be examined for polymorphisms in specific genes that are chosen in the light of the prior literature scanning. to the investigators' knowledge, this will be the first study of a broad scanning of polymorphisms related with bpd in turkish population.

bronchopulmonary dysplasia is a chronic lung disease that affects a ratio of up to 20-30% of infants prematurely born before 30rd week. delay of starting to speak, cerebral palsy and cognitive disorders may be seen in infants suffering from this disease. although all the evidence found on the specific mediators and pathways that regulate the mechanism by studies made to understand the pathophysiologic mechanism, there hasn't been any remarkable progress on preventing the development of bpd in new-born infants born below 1500gr body weight. bpd is still one of the most important morbidity and mortality reasons in premature infants. there is a need of further studies to understand the genetic background of bpd specific to different populations, to identify polymorphisms related with the disease and for developing genetic methods for early the diagnose of the disease. with this purpose, first of all polymorphisms related with bpd and those which are related with similar other lung diseases will be investigated. dna samples derived from blood samples of 200 patients (100 bpd infant and 100 control) will be examined for polymorphisms in specific genes that are chosen in the light of the prior literature scanning. to the investigators' knowledge, this will be the first study of a broad scanning of polymorphisms related with bpd in turkish population.

Eligibility criteria:
inclusion criteria: * infants born under 30 gestational week * infants with bronchopulmonary displasia exclusion criteria: * major congenital abnormalities * lack of data * parents don't agree with informed consent
immunological characteristics of patients with pid and ibd

Conditions: Inflammatory Bowel Diseases; Primary Immune Deficiency Disorder

Summary: the investigators wish to characterize alterations in the architecture and function of immune cells in patients with a primary immunodeficiency that also develop inflammatory bowel disease. in addition, the investigators' goal is to characterize the microbiome of these patients, in order to determine whether specific microbial alterations are related to inflammation.

the pathogenesis of inflammatory bowel diseases (ibd), like crohn's disease and ulcerative colitis is complex and is thought to be related to genetic, environmental and microbial alterations that lead to a hyperactive/dysregulated immune system that mediates tissue damage. in rare cases, ibd can develop in patients with primary immunodeficiencies (pid) who develop severe, atypical or recurrent infections. the bowel disease in these patients can present after they develop infectious complications but also prior to that. the goal of the current study is to characterize immune function in patients with pid and ibd in order to identify alterations in pro-inflammatory and regulatory pathways. the investigators will obtain blood samples from pid patients with ibd in order to perform deep immune profiling using various techniques such as flow cytometry, elisa and others. moreover, the investigators wish to characterize the microbiome of these patients. this multi-disciplinary approach will advance our understanding why specific patients with an immunodeficiency develop an ibd-like phenotype.

Eligibility criteria:
inclusion criteria: * age \<18 years * diagnosis of an immunodeficiency * suspected or confirmed ibd exclusion criteria: * none
the healing of soft tissue augmentation by acellular dermal matrix and autogenous subepithelial connective tissue graft

Conditions: Gingival Recession, Generalized; Graft Reaction

Summary: the study team proposes to prospectively compare the healing outcomes of autogenous soft tissue connective tissue graft (ctg) and acellular dermis matrix (adm) in a split-mouth design study for patients requiring modification of gingival soft tissue biotype. the researchers aim to investigate the earlier phase of graft healing after the grafting surgery by biopsy histology and by examining the alteration of gene profile during the healing of gingival tissue healing by molecular cell biological techniques.

the investigators will perform a prospective clinical randomized controlled trial, and recruit 12 patients who need gingival soft tissue augmentation. it is a split-mouth design: ctg will be used in one side of soft tissue augmentation, and adm will be used on the other side. 3 months after graft healing, clinical measurements including soft tissue thickness, transparency visualization, tissue profile record with impression cast study model, and digital photography of tissue will be performed. the gingival punch biopsies ( 2mm diameters) will be performed in both sides of grafting areas under the local oral anesthesia injection. the collected tissue will be split into two halves, one for histological examination, and another half for gene analysis.

Eligibility criteria:
inclusion criteria: * general healthy * periodontal healthy (no pd \>3mm, no bop, no mobility at the test site and control site) * patients identified need gingival biotype modification (need for increased tissue thickness) during the periodontal exam or referred from orthodontics exclusion criteria: * current smoker or smoking history * taking antibiotics or medicines within the last 3 months * past history of gingival soft tissue augmentation/modification surgery
resection of the nerve plexus on the right half of celiac and sma associated with extended pancreatoduodenectomy in the surgical treatment for adenocarcinoma of the head of pancreas

Conditions: Pancreatic Cancer

Summary: this study is performed to confirm whether resection of the nerve plexus on the right half of celiac and sma associated with extended pancreatoduodenectomy could improve survival and relieve pain of pancreatic cancer patients.

lymph node metastasis and nerve invasion are characteristics of pancreatic cancer. for pancreatic head cancer, celiac and sma nerve plexus are often involved. many surgeons started to improve the surgical approach of pancreatoduodenectomy by extending the extent of surgical resection including an extended lymph node dissection and nerve plexus clearance in the hope of achieving better long-term survival rate. postoperative complications such as diarrhea and malnutrition were reported after celiac and sma nerve plexus resection during pancreatoduodenectomy. as a result, resection of the nerve plexus on the right half of celiac and sma associated with extended pancreatoduodenectomy was recommended. this study is performed to confirm whether resection of the nerve plexus on the right half of celiac and sma associated with extended pancreatoduodenectomy could improve survival and relieve pain of pancreatic cancer patients. subjects undergoing surgery will be randomized to extended pancreatoduodenectomy with resection of the nerve plexus on the right half of celiac and sma versus standard pancreatoduodenectomy. subjects will be followed every two months for survivorship or death to assess pain, quality of life measures, and narcotic pain control usage. the primary endpoint of overall survival and the secondary endpoint of disease-specific free survival will be determined at two year post surgery.

Eligibility criteria:
inclusion criteria: * signed informed content obtained prior to treatment * age ≥ 18 years and ≤ 80 years * eastern cooperative oncology group (ecog) performance status 0-2 * the pathological staging does not exceed the stage iib * the expected survival after surgery ≥ 3 months * tumor locates at the head of the pancreas without distant metastasis * no celiac trunk and superior mesenteric artery invasion by loyer grading * no operation contraindication exclusion criteria: * the pathological staging exceed the stage iib * pancreatic cancer at the body and tail of the pancreas * benign tumor at the head of the pancreas * distant metastasis * severe important organ function impairment * active second primary malignancy or history of second primary malignancy within the last 3 years * pregnant or nursing women * human immunodeficiency virus (hiv)-positive patients * patients who are unwilling or unable to comply with study procedures
a phase 2, open-label study of amg 706 to treat subjects with locally advanced or metastatic thyroid cancer

Conditions: Thyroid Cancer

Summary: the purpose of the study is to determine if amg 706 will have clinically meaningful anti-tumor activity in subjects with locally advanced or metastatic thyroid cancer who are not candidates for radioactive iodine therapy or local therapies.


Eligibility criteria:
inclusion criteria: - histologically confirmed locally advanced or metastatic thyroid cancer - measurable disease - normal blood pressure (if history of hypertension, blood pressure must be controlled with medication) - evidence of disease progression within 6 months before starting study (for differentiated thyroid cancer subjects) - evidence of disease progression within 6 months before starting study or symptomatic disease (for medullary thyroid cancer subjects) - not a candidate for surgical resection, external beam radiotherapy, radioiodine therapy, or other local therapy - at least 18 years of age exclusion criteria: - undifferentiated/anaplastic thyroid cancer - untreated or symptomatic brain metastases - prior malignancy, unless cured with treatment and no evidence of disease for greater than or equal to 3 years before starting study (history of thyroid cancer, in situ cervical cancer, or basal cell cancer of skin are exceptions) - myocardial infarction or any unstable cardiac condition (e.g., congestive heart failure, unstable angina) within 1 year before starting study - arterial thrombosis or deep vein thrombosis within 1 year before starting study

Keywords: thyroid cancer advanced thyroid cancer metastatic thyroid cancer medullary thyroid cancer follicular thyroid cancer papillary thyroid cancer hurthle cell thyroid cancer thyroid cancer treatments differentiated thyroid cancer and medullary thyroid cancer
efficacy and tolerability of topical lfx453 for external genital warts

Conditions: External Genital Warts

Summary: the lfx453x2202 study tested the investigational drug lfx453 against placebo for safety, tolerability, and efficacy in treating genital warts in circumcised men, in parallel with an additional open label arm using imiquimod 5%. during the study the patients received either lfx453, placebo or active comparator and the tolerability and safety was assessed continuously through local tolerability assessments and adverse event recorded. efficacy was clinical evaluations and lesion count. during the study biopsies were taken for analysis of pharmacokinetics and biomarkers. blood samples were taken for safety, pharmacokinetics (pk), and biomarkers.


Eligibility criteria:
inclusion criteria: * signed informed consent * circumcised male 18-60 years * clinical diagnosis of external genital warts * agree to remain abstinent or to use condoms during intercourse for the duration of the study * agree to digital photographs of treated area exclusion criteria: * any treatment of genital warts within one month of treatment start * hpv vaccination * presence of warts larger than 200 mm2 * genital herpes within one month of treatment start * history of bowenoid papulosis * significant illness within 2 weeks of treatment start * use of other investigational drugs * known hypersensitivity to study drugs or constituents * history of ecg abnormalities * history of significant heart conditions * impaired renal function * abnormal liver function * history of immunodeficiency disease * drug or alcohol abuse * immunosuppressive therapies * malignancies in the past 5 years * hypertrophic scarring

Keywords: human papilloma virus (hpv), genital warts, sexually transmitted disease (std), viral disease
end-of-life decisions in surgical intensive care medicine - the relevance of treatment withholding

Conditions: Quality of Life

Summary: the purpose of this retrospective observational study is to describe the sequence of icu-therapies that are limited and to compare characteristics and the decision making process in surgical icu-patients.

decisions to limit life-support therapy are common on the intensive care unit (icu). end-of-life decisions (eold) underlie a dynamic process and limitation of icu-therapies is done sequentially. questionnaire-based and observational studies on medical icus and in palliative care reveal blood transfusions as the first therapy physicians withhold in eolds. whether this practice also applies to surgical icu-patients is unknown. the purpose of this retrospective observational study is to describe the sequence of icu-therapies that are limited and to compare characteristics and the decision making process in surgical icu-patients.

Eligibility criteria:
inclusion criteria: * all surgical patients admitted to the icu all surgical patients discharged death from the icu exclusion criteria: * all patients discharged alive from the icu
improving medication adherence in chronic heart failure using a telemedicine device (telemed-hf)

Conditions: Heart Failure

Summary: telemed-hf is a randomized, controlled clinical intervention trial designed to: (1) examine the efficacy of an electronic medication adherence support system (mass) in improving and monitoring patients' medication adherence; to (2) i determine the effect of medication adherence on hospitalization and health care consumption.


Eligibility criteria:
inclusion criteria: * stable systolic heart failure * new york heart association functional class ii-iii, with a decreased pump function (left ventricular ejection fraction (lvef) \<45%) * titrated to the most optimal doses of ace-inhibitor or angiotensin receptor blocker, and beta-blocker * receiving stable doses of at least 3 heart failure medications (at multiple times during the day) for 1 month with no plans to add or adjust heart failure medications or titrate further in the immediate future. exclusion criteria: * age younger than 50 years * diastolic heart failure (intact pump function) * myocardial infarction, invasive treatment (percutaneous coronary intervention (pci) or coronary artery bypass grafting (cabg)), or hospitalization within 1 month prior to inclusion * life-threatening comorbid conditions (e.g., cancer) * diminished mental capacities (suspected cognitive decline will be confirmed by a mini mental state examination (mmse)) * history of psychiatric disorders apart from affective disorders (depression and anxiety disorders)

Keywords: medication adherence heart failure telemonitoring determinants of adherence
altered faecal microbiome and metabolome in ct1d, at1d and t2d

Conditions: Type 1 Diabetes Mellitus Maturity Onset

Summary: to elucidate the characteristics of global gut microbiota and fecal/serum metabolites in patients with childhood-onset type 1 diabetes, adult-onset type 1 diabetes or type 2 diabetes.

type 1 diabetes is caused by autoimmune destruction of pancreatic beta cells, leading to severe insulin deficiency and requiring insulin therapy. it is typically considered a disease of childhood and adolescence, but recent epidemiological data have shown that over half of all new-onset type 1 diabetes cases occur in adults worldwide. there are genetic, immune and metabolic differences between adult- and childhood-onset type 1 diabetes, revealing the underlying molecular basis of type 1 diabetes onset at diverse ages may differ. accurate diagnosis is of great importance because the best treatment for different types of diabetes is divergent. misdiagnosing type 2 diabetes as type 1 diabetes can lead to unnecessary initial insulin therapy, resulting in higher costs and more side effects. thus, it is critical to identify the molecular basis and new diagnostic biomarkers for adult-onset type 1 diabetes. nonetheless, environmental exposures, in particular the immense intestinal microbiota and its derivatives, have been widely investigated. indeed, patients with childhood-onset type 1 diabetes or type 2 diabetes exhibit compositional alterations in gut microbiota. however, gut microbiota in adult-onset type 1 diabetes has not been elucidated, and little is known about the shared and distinct microbial characteristics in adult-onset type 1 diabetes versus childhood-onset type 1 diabetes or type 2 diabetes. thus, this study is a cross-sectional study. 4 groups of subjects were recruited for metagenome and metabolome analysis, including healthy controls and patients with childhood-onset type 1 diabetes, adult-onset type 1 diabetes or type 2 diabetes. all subjects recruited meet the inclusion or exclusion criteria and written informed consent was obtained from each participant at enrollment.

Eligibility criteria:
inclusion criteria: 1. diabetes diagnosed according to the report of who in 1999； 2. aged between 5 and 70 years old; exclusion criteria: 1. severe chronic cardiovascular or cerebrovascular disease； 2. severe abnormalities in liver or renal function; 3. hyperthyroidism; or other autoimmune diseases; 4. tumors, surgery or pregnancy; 5. treatments with oral hypoglycemic agents or immunomodulators; 6. subjects who had taken probiotics, prebiotics within one week or antibiotics within one month.

Keywords: adult-onset type 1 diabetes microbiota metabolomics