Kornimate/medical-research-clean huggingface dataset:
identification of risk factors associated with neoplastic complications after renal transplantation in nord-pas de calais , normandy and picardy regions

Conditions: Cancer of Kidney

Summary: kidney transplantation is now the treatment of choice for end-stage renal disease (esrd). between 2800 and 3000 kidney transplants are performed each year in france and more than 33 000 patients are living with a functioning graft. preventing allograft rejection requires the use of immunosuppressive therapy, the intensity decreases as the distance from the day of transplantation. unfortunately, treatment favors certain complications, including infectious and neoplastic. these represent a major cause of mortality in these patients. if the frequency of skin cancer is greatly increased in this population, that of solid tumors remains a concern. approximately 20% of patients develop cancer after 10 years of graft , half non- skin cancers, the main risk factor is immunosuppressive therapy . the aim of the study is to evaluate, in a large population of patients treated in 4 regions ( the nord-pas de calais, the upper and lower normandy and picardy) risk factors (in particular the nature of the immunosuppressive treatment) of developing a neoplastic complication, skin cancers and solid tumors, after renal transplantation.

a retrospective analysis of the previous 10 years, from 2002 to 2011 will be conducted. this study will better understand the epidemiology of these complications but also allow to identify risk factors associated, including demographic, environmental and related to immunosuppressive therapy. thereafter, we hope to implement preventive measures or prospective studies, allowing us to reduce the prevalence of this complication.

Eligibility criteria:
inclusion criteria: * all adult renal transplant patients in the 4 centers of interregion north - west * patients transplanted during the period from 1 january 2002 and 31 december 2011 * patients recipients of first, second or third renal transplantation * patients transplant recipients from a living or deceased donor whatever the immunological risk * eligible patients will be included after being informed by their doctor and after accepting their data to be processed in the framework of this study * patient with a health insurance coverage exclusion criteria: * patients transplanted as child * patients transplanted before 1 january 2002 * patients followed in the interregion but transplanted in another center * patients recipients of a double transplant (two kidneys or kidney plus other organ) * patients that do not accept their medical data to be included in the database

Keywords: grafting kidney cancer
immunogenicity of a commercial batch of jev ic51 up to 24 months post filling

Conditions: Japanese Encephalitis

Summary: the objective is to assess immunogenicity of a commercial ic51 batch at 3 different time points post filling (12, 18, 24 months) in terms of geometric mean titers (gmt) for anti-jev neutralizing antibodies at day 56 after the first vaccination.

open-label, multicenter, phase 3 study assessing immunogenicity at various time points throughout the shelf-life of a commercial batch of ic51 (batch ic51/07f/008) the study population consists of male and female healthy subjects, aged at least 18 years. the study will be performed at 3 study centers in germany and austria. three sequential cohorts, each containing 100 subjects, will be enrolled into the study at approximately 12, 18 and 24 months after filling of the commercial batch ic51/07f/008 of ic51

Eligibility criteria:
inclusion criteria: * male and female healthy adults aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test. exclusion criteria: * history of immunodeficiency or immunosuppressive therapy, known hiv infection, drug addiction including alcohol dependence, prior vaccination against je
a study of pd1 combined with dc-cik in the treatment of solid tumors

Conditions: Solid Tumor

Summary: this is a single center、single arm、open-label, to investigate the safety and efficacy of pd-1 and dc-cik with anti-solid tumor


Eligibility criteria:
inclusion criteria: 1. previously receiving ≥ first-line regimen chemotherapy; 2. age over 3 years old and less than 14 years old; 3. the expected survival period is more than 3 months; 4. ecog≤2; 5. vital organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥ 50%, no obvious abnormality in ecg; blood oxygen saturation ≥ 90%; creatinine clearance calculated by cockcroft-gault formula ≥ 40ml/min; alt and ast ≤ 3 times the normal range, total bilirubin ≤ 2.0 mg / dl; 6. blood routine: hgb≥80g/l, anc≥1×109/l, plt≥50×109/l; 7. there are measurable target lesions. exclusion criteria: 1. liver and kidney function: * total bilirubin \> 2 x uln (gilbert syndrome \> 3 x uln) * aspartate aminotransferase (ast) and alanine aminotransferase (alt) \> 3 × uln * serum creatinine clearance \>60ml/min 2. serological examination: * absolute neutrophil count (anc) \<0.75x109/l * platelet count (plt) \<50x109/l 3. active hepatitis b (hbv-dna \> 1000 copies / ml), hepatitis c, or uncontrolled infection; 4. the number of days of chemotherapy medication and the administration of hormones below 5mg is ≤3, and the number of days of withdrawal of hormones greater than 5mg is ≤5; 5. active cns disease (tumor cells in csf); 6. intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation; 7. creatinine \> 1.5 times the upper limit of normal or alt / ast \> 3 times the upper limit of normal or bilirubin \> 2 times the upper limit of normal; 8. the new york heart association (nyha) is classified as level iii or higher; 9. uncontrolled diabetes; 10. with other uncontrolled diseases, the investigator believes that it is not suitable for joining; 11. any situation that the investigator believes may increase the risk of the subject or interfere with the test results.
effect of polyherbal formulation in chronic inactive carriers of hepatitis b virus

Conditions: Chronic Hepatitis B

Summary: this trial will study the effect of a polyherbal capsule in lowering the viral load of patients with chronic hepatitis b infection and record the incidence of from hepatitis b surface antigen elimination in 12 months

a placebo controlled randomised trial. 3 herbs that have proven effect on eliminating the virus and normalizing liver function will be given. equally matched placebo (blinded) will be given randomly to patients. all parameters of hepatitis b infection will be compared between the randomized groups

Eligibility criteria:
inclusion criteria: * adults aged above 18 years of age, with inactive chronic hepatitis b (hb) or immune tolerant phase, with or without dyslipidaemia and having all of the following 1. hbsag +ve for \>6 months and anti-hbs negative 2. alanine amino transferase ≤ 2 upper limit of normal 3. hbeag positive or negative irrespective of viral dna load 4. not currently on antiviral therapy for chronic hepatitis b exclusion criteria: * any one of the following 1. patients with decompensated liver disease of any etiology(characterized by elevated bilirubin, raised international normalized ratio, or a history of ascites, variceal hemorrhage,hepatic encephalopathy, spontaneous bacterial peritonitis, hepatorenal syndrome or hepatocellular carcinoma) 2. family history of hepatocellular carcinoma 3. patients with hiv and hepatitis c virus co-morbidity 4. pregnant, attempting to conceive, or lactating women 5. patients with diabetes mellitus 6. recent history of acute coronary syndrome (\<6months) or chronic coronary artery disease with poor left ventricular function (by physician / cardiology opinion) 7. patients with renal failure ( creatinine clearance less than 60 ml/min) 8. active substance or alcohol abuse and concurrent use of corticosteroids or immunosuppressive agents. 9. presence of extra hepatic manifestations 10. previously treated with pegylated interferon within the last 2 years 11. positive fibroscan or ultrasound elastography showing evidence of fibrosis (f3 and above) 12. current or former employees of organic india 13. participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days. 14. refusing consent or physician uncomfortable with patient compliance to treatments or follow up.
effects of yoga on heart rate and heart rate variability responses to stress

Conditions: Cardiovascular Reactivity to Stress

Summary: introduction: yoga has been shown to reduce stress and have benefits for a number of stress-related disorders. however, the effects of an acute bout of yoga practice on cardiac autonomic response to and recovery from stress remain unclear. this study aimed to examine the effect of a single bout of yoga on heart rate (hr) and heart rate variability (hrv) response to and recovery from mental stress. materials and methods: this study was conducted with a randomized, counterbalanced, crossover design. a total of 44 participants completed two sessions (yoga and video watching (vw)) in randomly assigned order. after each condition, participants underwent a stroop task and mental arithmetic task. electrocardiogram was measured and hr and hrv for resting, each condition, and the stress and recovery periods were analyzed.


Eligibility criteria:
inclusion criteria: * aged between 20 and 40 years old * a body mass index (bmi) between 18.5 and 30 * being sedentary exclusion criteria: * electrocardiogram (ecg) abnormalities (e.g., arrhythmia, atrioventricular blocks) * history of cardiovascular disease, diabetes, or renal disease * contraindications for exercise (e.g., orthopedic problems) * involvement in any yoga practice * being pregnant or nursing * use of tobacco products or medications that may affect cardiovascular function

Keywords: yoga, mental stress, cardiac autonomic function, stress response
genetic study of atrial fibrillation: focusing on renin-angiotensin system and c-reactive protein genes

Conditions: Atrial Fibrillation

Summary: multi-locus and multi-gene studies of atrial fibrillation, focusing on renin-angiotensin system genes and c reactive protein gene


Eligibility criteria:
inclusion criteria: * patients with atrial fibrillation exclusion criteria: * patients with atrial fibrillation who are reluctant for the study
compliance monitoring in real time during opioid substitution treatment

Conditions: Opiate Dependence

Summary: the aim of the study is to examine whether electronic compliance monitoring in real time could offer some advantages compared to normal electronic monitoring in opioid substitution treatment. the investigators would also like know whether this method could enable the quick detection of possible problems in medication intakes and/or prevent the abuse or diversion of substitution medications.


Eligibility criteria:
inclusion criteria: * opiate dependence * suboxone treatment * stable substitution medication dose exclusion criteria: * chaotic situation in life

Keywords: opiate dependence compliance monitoring substitution treatment
attenuation corrected cardiac spect using the ge hawkeye camera system

Conditions: Cardiac Disease

Summary: the accuracy of stress single photon emission computed tomography (spect) is limited by imaging artifacts, many of which are caused by soft tissue attenuation. a recent multicenter study performed by our laboratory comparing 7 commercially available attenuation correction (ac) camera systems in a cardiac phantom showed the best performance with the ge hawkeye (a hybrid gamma camera-ct scanner) and the university of michigan m-step (unique feature a camera orbit of 360˚ versus the usual 180˚) systems. in this study we will combine the strengths of these two systems (ge hawkeye ac system and 360˚ camera orbit) to test the accuracy of this imaging system in a population of 400 consecutive patients undergoing clinically indicated stress spect. these patients will undergo spect imaging both with conventional methodology and the ge hawkeye system. the conventional study will be interpreted and reported in the usual clinical fashion. the ge hawkeye images will be interpreted independently by 2 observers blinded to the results of conventional imaging and will not be reported clinically. the primary study hypothesis is that ac will substantially reduce attenuation artifacts (mild fixed defects) without reducing the accuracy of either normal studies or myocardial infarction (mi). clinical data and noninvasive test results (history of mi, electrocardiogram, and gated wall motion) will be used to distinguish defects which represent attenuation (false-positive) versus those due to mi (true-positive).


Eligibility criteria:
inclusion criteria: * patients referred to the charlton nuclear cardiology laboratory for stress tc-99m sestamibi spect exclusion criteria: * prior ptca or cabg * left bundle branch block (lbbb) or paced ventricular rhythm * clinically significant valvular heart disease * hypertrophic or idiopathic dilated cardiomyopathy * atrial fibrillation or frequent atrial or ventricular ectopy (defined as \>20% ectopic beats * history of mi * ecg evidence of mi * chest circumference \>55 inches

Keywords: heart disease cardiac disease chest pain myocardial infarction heart attack
succinate salt version of gsk961081 for healthy volunteers

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: salt bridging study for gsk961081


Eligibility criteria:
inclusion criteria: * healthy adult males or female aged between 18 and 50 years. * body mass index within the range 19-29.9 kilograms/metre2 * forced expiratory volume in 1 second (fev1) \>80% predicted and a fev1/ forced vital capacity (fvc) ratio \> 0.7 * subjects are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of \< 10 pack years. exclusion criteria: * who have a past or present disease, which as judged by the investigator and medical monitor may affect the outcome of the study or the safety of the subject * history of respiratory disease * significant abnormal 12 lead ecg, qtc(b) and qtc(f) value at screening \>450msec on an individual ecg or a pr interval outside the range 120-210 msec * supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening. * subject has donated a unit of blood within the 56 days or intends to donate within 56 days after completing the study * subject is currently taking regular (or course of) medication whether prescribed or not (with the exception of contraceptives, including vitamins and herbal remedies such as st john's wort. * subject has participated in a clinical study with a new chemical entity (nce) within the past 3 months * infected with the hepatitis b, hepatitis c, or hiv virus * subject has a history of drug or other allergy, which, in the opinion of the investigator, contraindicates their participation

Keywords: succinate anti-muscarinic b-agonist
motivational interviewing for weight loss with young adults

Conditions: Obesity

Summary: this study is a 2-arm randomized controlled trial to evaluate the feasibility, acceptability and preliminary efficacy of an mi-based program for weight loss in young adults.

this study is a 2-arm randomized controlled trial to evaluate the feasibility, acceptability and preliminary efficacy of an mi-based program for weight loss in young adults. participants will be assigned to either the mi behavioral weigh loss or behavioral weight loss arms - both arms will receive a 12-week behavioral weight loss program, including 2 individual in-person sessions, followed by weekly behavioral weight loss modules, reporting of key behaviors, and feedback on progress relative to goals, all via email. session content will be quite distinct between the two arms, with an increased emphasis on personalized feedback relative to healthy norms, enhancing autonomous motivation, and choice surrounding diet and activity goals in the mibwl arm. assessments will take place at 0, and 3 months, followed by exit interviews to help refine the protocol.

Eligibility criteria:
inclusion criteria: * between 18-25 years of age. * body mass index (bmi) between 25 and 45 kg/m2. * men and women will be recruited. * all race and ethnic groups will be recruited. exclusion criteria: 1. currently receiving treatment for type 2 diabetes, hypertension, hyperlipidemia, or report a history of cardiovascular disease. 2. other health problems which may influence the ability to walk for physical activity or be associated with unintentional weight change, including cancer treatment within the past 5 years or tuberculosis. 3. report a history of, or current diagnosed dsm-iv-tr eating disorder (i.e., anorexia nervosa or bulimia nervosa) or any current compensatory behaviors (e.g., vomiting, laxative use, excessive exercise). 4. report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the physical activity readiness questionnaire (par-q). individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate. 5. report a history of any psychotic disorder, bipolar disorder, or organic brain syndromes; report hospitalization for any psychiatric disorder within the last 12 months. 6. are currently participating in a weight loss program and/or taking weight loss medication. 7. lost \> 5% of body weight during the past 6 months or history of bariatric surgery. 8. participation in any other research study that may interfere with this study. 9. intend to move outside of the surrounding area within the time frame of the investigation or will be out of town / unavailable for three or more weeks during the initial intervention period. 10. are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation. 11. failure to complete screening appointments. -

Keywords: obesity weight loss young adults
use of new supraglottic airway devices in severely obese patients: a feasibility study

Conditions: Obesity

Summary: the purpose of this study is to determine whether two new airway devices used during anesthesia called igel™ and king-lts-dtm work well and are safe in obese patients. they both work well in thin patients, but have not been tested in obese patients.


Eligibility criteria:
inclusion criteria: * scheduled for elective surgery with an estimated duration of 30 to 120 minutes * american society of anesthesiologists (asa) status i-iii * aged 18 to 65 years. * body mass index (bmi) ≥ 35 kg/m2 exclusion criteria: * a history of difficult intubation; * immobilized cervical spine; * oxygen saturation less than 95% at room air; * a history of uncontrolled gastroesophageal reflux or hiatus hernia; * a history of ulcer surgery including vagotomy; * previous gastric bypass surgery; * diabetic gastroparesis; * patients with known coagulation disorders (e.g. hemophilias, von willebrand disease, factor v leiden diseases) or on systemic anticoagulation drugs (e.g. continuous heparin infusion); patients with abnormal coagulation tests will be also excluded. however, asymptomatic patients will not be tested on any coagulation disorders. * any pathologies of the mouth, pharynx or larynx, the access to the airway is restricted, or a difficult tracheal intubation is anticipated. * pregnant or breast-feeding (pregnancy status will be confirmed by a pregnancy test, as it is standard for all surgical procedures at the university hospital).

Keywords: anesthesia induction and maintenance surgery
a multicenter study of oral versus intravenous hydration in aids patients with cmv retinitis treated with foscavir (foscarnet sodium)

Conditions: Cytomegalovirus Retinitis; HIV Infections

Summary: to assess the relative efficacy of oral versus intravenous hydration during foscarnet sodium (foscavir) induction therapy, as determined by changes in creatinine clearance. to estimate the timing and volume of oral fluid hydration required to establish a diuresis before and during intravenous foscavir therapy. to assess the general tolerance of two hydration regimens by the adverse event profile associated with each.

patients are randomized to receive oral hydration versus intravenous hydration therapy during concomitant intermittent intravenous foscavir therapy for treatment of cytomegalovirus (cmv) retinitis. treatment continues during 2 or 3 weeks of induction foscavir therapy.

Eligibility criteria:
inclusion criteria patients must have: * documented hiv infection. * recent diagnosis of cmv retinitis, by ophthalmoscopic appearance, that requires induction therapy. * no corneal, lens, or vitreous opacification that precludes examination of the fundi. * no evidence of other end organ cmv infection. * no evidence of tuberculous, diabetic, or hypertensive retinopathy. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * clinically significant cardiac, pulmonary, neurologic, gastrointestinal or renal impairment that would prevent adequate voluntary oral hydration (e.g., intubation, coma, status post-gastrectomy, colon resection, gastrointestinal tumors, malabsorption, chronic diarrhea) or with which hydration would be hazardous (e.g., congestive heart failure). * known allergy to foscarnet or related compounds. * considered noncompliant or unreliable for study participation. concurrent medication: excluded: * any investigational drug. * potentially nephrotoxic drugs (e.g., amphotericin b, aminoglycosides, cisplatin). prior medication: excluded: * any investigational drug within 28 days prior to study entry. * potentially nephrotoxic drugs (e.g., amphotericin b, aminoglycosides, cisplatin) within 7 days prior to study entry.

Keywords: retinitis infusions, intravenous foscarnet cytomegalovirus infections administration, oral acquired immunodeficiency syndrome fluid therapy
umbilical cord blood mononuclear cell gel in the treatment of refractory diabetic foot ulcer

Conditions: Diabetic Foot Ulcer

Summary: umbilical cord blood mononuclear cells (mnc) may improve the wound repair ability. this study aims to investigate the role of mnc in refractory diabetic foot ulcer by comparing the combination of prp and mnc with prp alone.

the difficulty in the healing of diabetic foot is related to the loss of local repair microenvironment. the platelet rich plasma (prp) can improve the repair ability, however, the requirement for wound bed preparation is strict, or treatment failure may occur. umbilical cord blood mononuclear cells (mnc) may provide a better repair environment through paracrine action. this study aims to investigate the role of mnc in refractory diabetic foot ulcer by comparing the combination of prp and mnc with prp alone.

Eligibility criteria:
inclusion criteria: 1. the age of the patients is 18-80 years old; 2. diabetic foot is diagnosed and wagner grade is above ⅱ; 3. the duration of ulcer is 2 months or more, with no healing trend for 2 weeks or more. 4. fasting blood glucose ≤ 9mmol / l, 2 hours postprandial blood glucose ≤ 13mmol / l; 5. the skin oxygen partial pressure around the wound is more than 20mmhg; 6. sign written informed consent. exclusion criteria: 1. acute spreading infection of the wound, e.g. massive exudation, redness, swelling, heat, pain. 2. acute myocardial infarction, heart failure, hepatitis; 3. active bleeding or hematoma in the wound; 4. serum albumin \<25g/l; 5. hemoglobin \<80g/l; 6. platelets \<50×109/l; 7. poor cooperate or compliance;the patient cannot cooperate or is. 8. mentally disabled.

Keywords: diabetic foot ulcer umbilical cord blood mononuclear cells