Kornimate/medical-research-clean huggingface dataset:
different metabolic characteristics in the presence of brown adipose tissue in humans

Conditions: Metabolic Syndrome

Summary: functional brown adipose tissue (bat) exists in adult humans and can be detected by pet and especially during acute cold exposure. it is conceivable that bat activity might reduce the risk of developing obesity since fat stores are used for thermogenesis, and a directed enhancement of adipocyte metabolism might have value in weight reduction. so it is important to know the different metabolic characteristics in human adults who have detected bat. therefore, the purpose of the investigators study is to compare different metabolic characteristics in the presence of brown adipose tissue in humans.


Eligibility criteria:
inclusion criteria: * patients who underwent 18fdg-pet/ct scan year between 2008-2010 exclusion criteria: * history of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization) * diabetes * stage 2 hypertension * severe renal or hepatic disease
methylselenocysteine effects on circadian rhythm

Conditions: Breast Cancer; Prostate Cancer

Summary: the primary objective of this study is to determine if vitamin supplementation with a naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine) can restore disruption of circadian rhythm in shift workers.

all living cells have a circadian (daily) rhythm which controls a variety of bodily functions that change throughout the day, including body temperature, sleep, hunger, activity, hormone levels, etc. the circadian rhythm of the body is controlled by the amount of light that enters our eyes, so on our planet the length of the rhythm is 24 hours long. it is therefore reasonable to suspect that upsetting the timing of the rhythm would lead to changes in body function (as commonly experienced in "jet lag") and that prolonged changes might even lead to alterations in bodily functions and contribute to disease. this suggests that people whose service to the community that requires that they often work at night (nurses, doctors, police, hospital staff, firefighters, airline crews, factory workers, etc), might be at elevated risk of developing diseases. studies have shown that women who do shift work have an elevated risk of breast cancer, probably as a result of altered hormone levels and cycling. other studies have shown that vitamin supplementation with a naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine) can restore this disrupted rhythm and possibly decrease this disease risk. thus, the purpose of this study is to investigate whether taking daily selenium (i.e., methylselenocysteine) will restore the disrupted circadian rhythm in shift workers.

Eligibility criteria:
inclusion criteria: * permanent night shift schedule exclusion criteria: * nutritional supplements that contain selenium * pregnant * breast feeding * heart conditions * chronic lung disease * cancer therapy (current or past)
clinical investigation of erlotinib as an hcv entry inhibitor

Conditions: Chronic Hepatitis C Infection; HCV Genotype 1b

Summary: chronic hepatitis c virus (hcv) infection is a major cause of liver cirrhosis and hepatocellular carcinoma world-wide. current combination therapy of pegylated interferon-alfa, ribavirin and protease inhibitors is limited by resistance and substantial side effects. the investigators identified epidermal growth factor receptor (egfr) as host factor for hcv infection. inhibition of kinase function of egfr by approved inhibitor erlotinib (tarcevatm) broadly inhibits hcv infection of all major genotypes including viral escape variants resistant to host immune responses. completed preclinical proof-of-concept studies in hcv cell culture and animal model systems demonstrate that inhibition of egfr function by erlotinib constitutes a novel antiviral approach for prevention and treatment of hcv infection (european patent application ep 08 305 604.4, filing date: september 26, 2008; inserm, paris, france and lupberger et al. nature medicine 2011). since erlotinib (tarcevatm) is an established approved drug for cancer treatment and has a well characterized safety profile in humans, the aim of the study is to investigate the safety, efficacy and pharmacokinetics of erlotinib, a first-in-class entry inhibitor, for treatment of hcv infection in a randomized placebo-controlled double blind clinical trial in patients chronically infected with hcv. following completion, this trial will set the stage for a further investigation of entry inhibitors as antivirals in combination with standard of care or direct antivirals such as hcv protease inhibitors. thus, this randomized clinical trial will be an important step in the development of novel urgently needed antiviral therapies overcoming resistance.


Eligibility criteria:
inclusion criteria: * chronic genotype 1b hepatitis c infection with detectable hcv rna (\> 1x104 ui/ml) * naïve, relapser or non-responder to interferon with or without ribavirin * weight \> 45kg, bmi between 18 and 25 kg/m2 who had a liver biopsy or liver fibroscan eliminating the presence of cirrhosis in the year before enrollment, * non-smoker or occasional smoker ( ie \< 3 cig/day) exclusion criteria: * hiv or hbv infection * cirrhosis or liver decompensation * chronic liver disease non related to hcv

Keywords: hepatitis c virus infection entry inhibitor kinase inhibitor
relation between safety endpoints and everolimus trough blood level in advanced renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: the investigators hypothesize everolimus toxicities are linked to pharmacokinetic variabilities of everolimus. thus, early detection of clinical or biological risk factors will lead to personalized dosage treatment and permit a better tolerance without altering efficacy.


Eligibility criteria:
inclusion criteria: 1. patients aged ≥ 18 year-old. 2. histologically documented renal cell carcinoma whatever the type. 3. one or two prior therapy with cytokines and/or vefg-ligand inhibitors are permitted. 4. patients with an indication to receive everolimus treatment 5. patients able and willing to give written informed consent, before the first screening procedure. exclusion criteria: 1. patients currently receiving chemotherapy or immunotherapy 2. prior treatment with temsirolimus 3. contraindication in everolimus : * hypersensitivity to the active substance, to other rapamycin derivatives or to any of the excipients. * patients with severe hepatic impairment (child-pugh class c) * patients with rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. 4. pregnant or breastfeeding women 5. patients unwilling to or unable to comply with the protocol.

Keywords: cancer renal afinitor pharmacokinetics
factors associated with postoperative pain in patients undergoing tapp hernia repair for inguinal hernia

Conditions: Inguinal Hernia; Postoperative Pain

Summary: the most common symptom after an inguinal hernia is postoperative pain. according to the severity of the pain, the quality of life of the patient is also affected. there are many factors associated with postoperative pain. in this study, the results related to the factors affecting postoperative pain were investigated.

the most common symptom after an inguinal hernia is postoperative pain. according to the severity of the pain, the quality of life of the patient is also affected. there are many factors associated with postoperative pain. in the literature, there are factors whose relationship could not be determined clearly in the guidelines prepared for this. a meta-analysis showed that tapp was associated with less chronic pain than open hernia repair. in another study, it was reported that hernia size and type were unrelated to pain. in the same study, the relationship between preoperative pain and postoperative pain was examined. etele et al. reported that mesh fixation may increase pain. it is thought that the determination of these multiple predictive factors will both guide postoperative pain management and strengthen patient communication. as a result of the research, it is planned to obtain results related to the factors affecting the postoperative pain.

Eligibility criteria:
inclusion criteria: * patients undergoing tapp for inguinal hernia for the first time exclusion criteria: * patients under 18 years of age * patients undergoing open hernia repair * patients converted from laparoscopic to open * patients who are pregnant or likely to become pregnant * patients who cannot comply with the treatment or give their own consent for treatment due to their mental state

Keywords: inguinal hernia postoperative pain transabdominal preperitoneal repair visual analogue scale
intensive nutrition counselling in patients with head and neck cancer

Conditions: Head and Neck Squamous Cell Cancer

Summary: the purpose of this study is to assess the effect of a pre-planned patient-adjusted intensive nutritional counselling given by a dietitian several times during (chemo)radiotherapy vs. individualized nutritional counselling given by a dietitian once in the beginning of (chemo)radiotherapy and thereafter on-demand in patients with head and neck squamous cell cancer.

* a sample size of 102 patients was identified to achieve 30% reduction in prevalence of malnutrition at the end of treatment (50% to 20%), with a significance value of 5% (p \< 0.05), 90% power. the second calculation was for a sample size of 88 patients for 30% reduction in prevalence of malnutrition at the end of treatment (50% to 20%) with the significance value 5% (p\<0.05), 85% power and effect size 70%. based on these numbers, our aim is to recruit 100 patients, with the assumption that 12% patients would be lost to follow up. * randomization will be performed by the minimization procedure with the minim program® (http://www-users.york.ac.uk/\~mb55/guide/randsery.htm). the allocation will be done according to the following criteria: 1) stage i-ii vs. stage iii-iv; 2) age \ =65 year; 3) body mass index \ =20 kg/m2 and 4) tumour location (oral cavity-oropharynx-tonsils vs. hypopharynx-larynx vs. nasopharynx). * adverse events of chemoradiotherapy will be classified according to the national cancer institute common terminology criteria for adverse events-3.0 (ctcae v3.0) * nutritional status will be assessed by patient-generated subjective global assessment, nutritional risk screening-2002, upper-arm anthropometry (mac, triceps skinfold thickness, mama), bio-impedance, hand grip strength and weight loss. * survival: overall survival, disease-specific survival and disease-free survival are calculated.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of primary locally advanced squamous cell carcinoma of the oral cavity, pharynx, nasopharynx or larynx exclusion criteria: * renal function impairment * liver insufficiency * heart failure * pulmonal impairment * chronic obstructive pulmonary disease * cognitive impairment * previous cancer in any location * terminal stage

Keywords: nutritional status nutritional intervention handgrip strength patient-generated subjective global assessment chemoradiotherapy survival
randomized comparison of catheter-based strategies for interventional access site closure during transfemoral transcatheter aortic valve implantation

Conditions: Aortic Valve Stenosis

Summary: the aim of the study is to evaluate the clinical efficacy of 2 different vascular closure device (vcd) strategies during transfemoral transcatheter aortic valve implantation (tavi). the study hypothesizes that the choice of one over the other vcd in patients undergoing transfemoral tavi may demonstrate relevant differences in the rate of peri-procedural complications and effectiveness of vascular closure.

use of a plug-based vcd in patients undergoing transfemoral tavi as compared to a suture-based vcd.

Eligibility criteria:
inclusion criteria: 1. patients with an indication for transfemoral tavi as judged by the local heart team. 2. transfemoral access route and a commercially-available transcatheter aortic valve is selected by the local heart team. 3. the patient is willing to provide written informed consent and comply with protocol- specified follow-up evaluations. exclusion criteria: 1. vascular access site anatomy not suitable for percutaneous vascular closure. 2. vascular access site complications prior to the tavi procedure. 3. known allergy or hypersensitivity to any vcd component. 4. unstable active bleeding/ bleeding diathesis or significant unmanageable anemia. 5. absence of computed tomographic data of the access site before the procedure. 6. systemic infection or a local infection at or near the access site. 7. life expectancy of less than 6 months due to non-cardiac conditions. 8. patient cannot adhere to or complete the investigational protocol for any reason. 9. pregnant or nursing subjects. 10. participation in any other interventional trial.

Keywords: vascular access site closure transcatheter aortic valve implantation vascular closure device vascular access-site injury
anti-cd3 mab treatment of recent onset type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: this is a randomized placebo controlled study to test whether a single 14 course of treatment with the anti-cd3 monoclonal antibody, hokt3gamma1(ala-ala),teplizumab will prevent the loss of insulin secretory capacity in individuals with type 1 diabetes of 4 - 12 months duration since diagnosis.

the study design is a double blind placebo controlled trial that will enroll subjects between the ages of 8 - 30 who have had the diagnosis of type 1 diabetes made 4 - 12 months prior to enrollment. a single 14 course of treatment with mab hokt3gamma1(ala-ala), teplizumab will be given. the primary endpoint is the c-peptide response to a mixed meal at 12 months. a total of 60 subjects will be enrolled (30 in the drug treatment and 30 in the placebo groups) at 4 study sites: yale university,the university of california at san francisco, children's hospital of philadelphia, and the barbara davis diabetes center.

Eligibility criteria:
inclusion criteria: * age 8 - 30, * duration of diabetes 4 - 12 months, * weight greater than 27.5 kg, * stimulated c-peptide \>= 0.2 pmol/ml exclusion criteria: * asthma, * history of hepatitis c, hepatitis b, hiv

Keywords: immune therapy autoimmunity insulin secretion diabetes mellitus
a single dose, phase 1 study of yh35324 in patients with various allergic diseases

Conditions: Allergic Disease; Chronic Spontaneous Urticaria; Chronic Inducible Urticaria; Cold Urticaria

Summary: this study aims to evaluate the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) following a single subcutaneous injection of yh35324 in subjects with various allergic diseases.

this drug(yh35324) is currently under development as a novel therapeutic agent for various ige-mediated allergic diseases. since yh35324 exhibits high binding affinity to human ige, it prevents serum ige from binding to receptors on mast cells and basophils, thereby inhibiting histamine release via degranulation following allergen exposures. in addition, yh35324 suppresses autoantibody-dependent effector cell activation by blocking anti-fcεriα autoantibodies. this study aims to evaluate the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) following a single subcutaneous injection of yh35324 in subjects with various allergic diseases.

Eligibility criteria:
inclusion criteria: * male or female adults aged ≥ 19 to ≤ 75 years \[parts 1 and 2 only\] * diagnosis of csu \[part 2 only\] * experience of inadequately uncontrolled csu despite use of omalizumab \[part 3 only\] * diagnosis of chronic inducible urticaria (cold urticaria) exclusion criteria: * history of malignancy within 5 years from screening * aspartate transaminase (ast) or alanine transaminase (alt) level \&gt; 2 x the upper limit of normal \[parts 1 and 2 only\] * chronic urticaria with clear etiology other than csu \[part 3 only\] * chronic urticaria other than studied chronic inducible urticaria (cold urticaria) the above information is not intended to contain all considerations relevant to a patient potential participation in a clinical trial.

Keywords: gi-301 yh35324 allergic disease csu cindu cold urticaria
amplatzer™ laa occluder post approval study (pas)

Conditions: Atrial Fibrillation; Thromboembolism; Stroke

Summary: the aim of this multicenter, non-randomized observational post-approval is to compile real world outcome data on the use of an amplatzer laa occluder in subjects with non-valvular atrial fibrillation (nvaf). the amplatzer laa occluders is a transcatheter, self-expanding nitinol device intended for use in preventing thrombus embolization from the laa.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * documented history of nonvalvular atrial fibrillation * subjects in whom an amplatzer laa occluder device is intended to be implanted or subjects who underwent an amplatzer laa occluder implant attempt after the device was approved in the applicable geography exclusion criteria: * women of childbearing potential who are, or plan to become, pregnant during the time of the study

Keywords: atrial fibrillation stroke left atrial appendage cardiac plug amulet thromboembolism
evaluation of the auryzon devices in the optimization of ear and nose reconstruction procedures

Conditions: Ear Deformities, Acquired; Ear; Deformity, Congenital; Microtia; Nose Deformity; Nose Deformities, Acquired; Nose; Deformity, Congenital; Nose; Deformity, Congenital, Bent or Squashed; Nose; Deformity, Syphilitic, Congenital; Nose; Deformity, Bone (Nose Cartilage); Nose; Deformity, Septum, Congenital; Nose; Deformity, Sinus (Wall), Congenital; Nose; Deformity, Syphilitic, Late (Etiology); Ear; Deformity, External; Ear; Deformity, Auricle, Ear, Acquired; Ear; Deformity, Auricle, Ear (Congenital)

Summary: this study evaluates the efficacy of the auryzon devices in the ear and nose reconstruction surgeries, both in terms of operative time and overall quality of reconstruction. research participants will undergo reconstruction either using the auryzon device or through current methods (traditional manual processing) at the discretion of their surgeon prior to the start of surgery.

the auryzon devices are a family of two (2) devices that, in conjunction, serve to process substrates of autologous-derived or cadaveric cartilage used in the reconstruction of various structures of the body, namely ear and nose. the devices are to be used in the operating room to cut and carve substrates of tissue into components, which are then assembled into the final ear or nose, that will then be implanted by the plastic surgeon into the appropriate area. this device family serves to replace the current step in this reconstructive procedure, which involves the time-consuming and error-prone process of manual cartilage processing. participants will be given the option to participate in the study. if the participants so choose, they will undergo ear or nose reconstruction using the auryzon devices or traditional manual processing at the discretion of their surgeon prior to the start of surgery. the following outcome measures will be measured: operative time, error rates, objective quality outcomes of reconstruction, subjective quality outcomes of reconstruction, and patient satisfaction.

Eligibility criteria:
inclusion criteria: * patients aged 1-100 of sufficient health required to undergo ear/nose reconstruction under general anesthesia * pre-existing physical deformity of the ear, nose, or eyelid necessitating surgical reconstruction * sufficient autologous or cadaveric rib cartilage for use by the auryzon system for cartilage processing exclusion criteria: * patients with ear/nose/eyelid deformities not requiring surgical correction * patients without sufficient rib cartilage for use by the auryzon system and those who do not desire cadaveric cartilage use * patients in poor health to undergo surgery under general anesthesia * patients whose desired ear/nose/eyelid exceeds the dimensions/shapes of those pre-fabricated blades used in the auryzon system
effects of intrathecal local anesthetics on left ventricular global longitudinal strain

Conditions: Left Ventricular Dysfunction; Spinal Anesthetics Causing Adverse Effects in Therapeutic Use; Global Cardiac Wall Motion Dysfunction

Summary: the objective of this study is to assess the effects of intrathecal local anesthetics on left ventricular global longitudinal strain (lvgls) using transthoracic echocardiography (tte).


Eligibility criteria:
inclusion criteria: * adult patients undergoing elective knee and hip replacements under spinal anesthesia exclusion criteria: * patients who do not wish to consent * patients with contraindications to tte * patients with reduced left ventricular systolic function as defined by lv ejection fraction \< 50% on pre-operative echocardiography * patients with body mass index greater than 40 * non-english-speaking subjects * cognitively impaired adults

Keywords: strain