Kornimate/medical-research-clean huggingface dataset:
cell mediated immunity in older adults

Conditions: Immunity to Influenza Vaccine

Summary: this study is to study the immune response to the flu vaccine in people 65 years old and older. only adults 65 years old and older and who are getting their flu vaccine are being asked to join in this study. the investigators plan to enroll approximately 100 people in this study in the 2010-2011 flu season. vanderbilt is working with the centers for disease control and prevention on this study. there will be 5 study visits. up to 4 tablespoons of blood from a vein will be obtained prior to the flu shot. return visits will be 1, 2, and 4 weeks later,with up to 4 tablespoons of blood drawn again. patients will be randomized to receive either the standard dose or the high dose flu vaccine. both flu vaccines are fda-approved.

during the 2010-2011 influenza season, approximately 100 adults ≥65 years of age will be enrolled. after consent, blood and serum will be collected and then subjects will be randomized to either standard or high dose influenza vaccine (both fda approved vaccines). vaccination will be done by an unblinded nurse. all further evaluations and analysis will be done by a blinded staff member. medical history, relevant medications, and functional/nutritional status will be assessed at the first visit. subjects will return (table 3) for blood and serum draws on days 7, 14, 28 and for a serum blood draw after influenza season. no micronutrient samples will be drawn, but serum will be kept for possible vitamin d testing. during influenza season, subjects will answer a questionnaire about influenza-like illness (ili) every two weeks (either by email or telephone) and will be asked to return for a nasal swab if an ili is present. comparisons will be made of the cell-mediated response of those vaccinated with standard versus high dose vaccines. analyses will be done accounting for age, use of immunomodulating agents, and underlying medical conditions.

Eligibility criteria:
inclusion criteria: * healthy * aged 65+ years exclusion criteria: * \<65 years * influenza vaccine allergy * guillain-barre * weight \<110 pounds

Keywords: influenza vaccine cell mediated immunity elderly high dose influenza vaccine
evaluate efficacy, safety and tolerability of azd1656 as add-on treatment to metformin in type 2 diabetes mellitus (td2m) patients

Conditions: Type II Diabetes Mellitus

Summary: the primary aim is to evaluate efficacy, safety and tolerability of azd1656 as add-on treatment to metformin in td2m patients


Eligibility criteria:
inclusion criteria: * female of non-childbearing potential * treated with maximally tolerated dose of metformin (≥ 1500mg/day) for at least 10 weeks prior to enrolment. * patients with hba1c ≥ 7.5 but ≤ 10% at enrolment visit (visit 1) can enter cohort 1.patients with hba1c between \>10 % and \<12 % can enter the open-label arm with azd1656 (cohort 2) exclusion criteria: * significant cardiovascular event within the last 6 months prior to enrolment or heart failure new york heart association (nyha) class iii-iv. * impaired renal function in terms of gfr\<60 ml/min, based on modification of diet in renal disease study group (mdrd) calculation. * use of warfarin or amiodarone within 3 months prior to enrolment (screening) and use of potent cyp450 inhibitors, eg, ketoconazole and/or macrolide antibiotics within 14 days before randomisation.

Keywords: type ii diabetes mellitus metformin glipizide
a study to determine the safety and efficacy of once daily raltegravir compared to twice daily raltegravir (mk-0518-071)

Conditions: HIV

Summary: a study to evaluate the safety, tolerability and efficacy of once daily raltegravir compared to twice daily raltegravir when each is given in combination with truvada™ in treatment-naïve human immunodeficiency virus (hiv)-infected patients.

following the 96-week double-blind study period (mk0518-071)(nct00745823), subjects may enroll in an extension study (mk0518-071-10)(nct00745823). from weeks 96 to 120, subjects' treatment assignments will remain as in the base study. from week 120 to 240, all subjects will receive open-label raltegravir (800 mg, once daily) in combination with truvada™.

Eligibility criteria:
inclusion criteria: * patient is male or female 18 years of age or older * patient is hiv positive * patient is naïve to antiretroviral therapy (art) or has received less than 7 days total of any art extension study: * the planned extension study did not take place as the study was terminated after the week 48 analysis. exclusion criteria: * patient is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence * patient has documented resistance to tenofovir or emtricitabine * patient is currently participating or has participated in a study with an investigational compound or device within 45 days of signing informed consent * patient is pregnant or breastfeeding, or expecting to conceive

Keywords: hiv infections treatment naïve
can fat derived stem cells (svf) be used in the treatment of erectile dysfunction after prostatectomy

Conditions: Delayed Graft Function

Summary: prostate cancer is the most common cancer among danish men, and the incidence is increasing. studies have shown a high number needed to treat for each saved prostate cancer related death. since the treatments incur many complications, there is a need to address these. after prostatectomy, 80% experience erectile dysfunction. sexual life is a central part of people's identity, self-esteem and quality of life. stem cells have generated a large amount of promising data suggesting that stem cells can alleviate erectile dysfunction, by regenerating nerves as well as endothelial and smooth muscle cells in the corpus cavernous.

prostate cancer is the most common cancer among danish men, and the incidence is increasing. studies have shown a high number needed to treat for each saved prostate cancer related death. after prostatectomy, 80% experience erectile dysfunction. sexual life is a central part of people's identity, self-esteem and quality of life. stem cells have generated a large amount of promising data suggesting that stem cells can alleviate erectile dysfunction, by regenerating nerves as well as endothelial and smooth muscle cells in the corpus cavernous. animal studies have used stem cell therapy to improve erectile dysfunction in rats after cavernous nerve damage, with invariable high success rate. in this pilot study will include 30 patient's with erectile dysfunction 3-9 mdr after prostatectomy. the men have no spontaneous erectile function and no response to drug treatment. liposuction is carried out in general anesthesia. isolation of stem cells will be done simultaneously and the stem cells injected into the corpus cavernous directly after the isolation is carried out. this is a clinical study evaluating an innovative cell therapy procedure.the objective of this study was to evaluate the effects of injection of stem cell of adipose origin. the project will run over a period of twelve months. patients will be followed for a period of six months. treatment efficacy will be assessed from validated questionnaires.

Eligibility criteria:
inclusion criteria: * men who have had prostate removed due to prostate cancer regardless bilateral nerve-sparing, unilateral nerve-sparing or non-nerve-sparing surgical technique. * erectile dysfunction * sexually active/ have sexual interest * we make no distinction for the patients are operated with exclusion criteria: * absence of sexual interest. * patients with impaired health condition where anesthesia would be a risk of complications. * bmi below 20. * small amount of abdominal fat assessed by. ct abdomen. * patients on anticoagulant treatment. * men with suspicion of residual tumor.

Keywords: erectile function mesenchymal stromal cells stem cell
"holding-cuddling" plus oral sucrose versus oral sucrose for reducing venipuncture pain in newborns and infants

Conditions: Blood Sampling

Summary: "holding-cuddling" plus oral sucrose versus oral sucrose for reducing venipuncture pain in newborns and infants. neonates and infants routinely undergo venipuncture in pediatric and neonatal intensive care units. such procedure is painful and several units administer 24% oral sucrose with pacifier during venipuncture, as this non-pharmacological intervention is considered safe and effective for procedural pain relief in infants from birth to 3 months of age. however, several studies point out that further research is needed to assess its efficacy in combination with other behavioral interventions for analgesia during painful procedures. current knowledge suggests that multisensorial stimulation associated with oral sucrose could allow even more effective analgesia. to date, the studied stimulation strategies are based on massage, voice, eye contact and fragrance during heel prick. the "holding-cuddling" - that is the fact of holding the child in a safe, reassuring and warm position during the examination or medical intervention is promoted by various hospitals in order to favor the comfort of all the caregivers during such a procedures. this intervention should be primarily parents-driven but, in case of unavailability, it can be performed by the nursing staff. the hypothesis of this study is that the combination of "holding-cuddling" plus oral sucrose in more effective than oral sucrose in diminishing behavioral pain response during a venipuncture in newborns or infants less than three-month-old.


Eligibility criteria:
inclusion criteria: * hospitalization at chu de la réunion - site sud in neonatal intensive care unit or neonatology unit. (neonate reanimation, pediatric reanimation or neonatology services) * informed consent from holder(s) of the parental authority exclusion criteria: * intubated ou sedated patients * treated with a combined analgesic during venipuncture * having indications against sucrose * for which behavorial items from dan scale are difficult to evaluate regarding their pathology (ex: severe neuromotor handicap)
developing cognitive training for tourette syndrome

Conditions: Tourette Syndrome; Chronic Tic Disorders

Summary: many researchers suspect that individuals with tourette syndrome (ts) may have a poor cognitive ability (i.e., response inhibition; ri) that is essential to inhibit inappropriate response such as vocal or motor tics. the investigators aim to test whether a well-established behavior therapy for ts can be improved by increasing the individual's ri capabilities. to this end, 20 children will be randomly assigned to behavior therapy with computer-based ri training or behavior therapy with placebo computer-based cognitive training. the investigators will test the hypothesis that computer-based ri training can be a useful addition to the well-established behavior therapy to enhance its therapeutic effect.

the current research seeks to examine the feasibility of using a computer-based ri training program as an adjunctive intervention for the comprehensive behavioral intervention for tics (cbit). our central hypothesis is that cognitive training designed to enhance ri will potentiate treatment outcomes of cbit. to this end, the investigators will conduct a two-arm placebo-controlled double-blind trial, in which 20 children with ts will be randomly assigned to cbit with computerized ri training (cbit+rit; n=10) or cbit with placebo computer training (cbit +plt; n=10). cbit consists of eight weekly sessions that present awareness training, competing response training, relaxation training and functional contingency management in a manualized format. the adjunctive computer training (rit or plt) will be delivered during the first 4 weeks of cbit/hrt (i.e. 8 twice-weekly 40-min sessions). tic symptoms and ri capabilities will be assessed at baseline, mid-treatment, post-treatment, and 1 month follow-up. this project is expected to increase our understanding about the nature of response inhibition deficits in ts and generate knowledge that will guide the development of effective cognitive interventions for ts.

Eligibility criteria:
inclusion criteria: * age between 9 and 17 * a diagnosis of ts or chronic tic disorder on the structured diagnostic interview * moderate to severe levels of tic symptoms (ygtss total score \> 13 for ts, or \> 9 for ctd), and (d) iq \> 80. exclusion criteria: * current substance abuse or dependence * current or past psychotic disorder, bipolar disorder, or schizophrenia * 4 or more previous sessions of behavioral treatments for tic * significant suicidal ideation and/or attempts within the past 3 months * any recent (in the previous month) or planned change in medication for tic symptoms.

Keywords: tic disorder tourette syndrome habit reversal response inhibition cognitive retraining
automatic ct-to-patient registration during navigated bronchoscopy and ebus

Conditions: Bronchial Neoplasms

Summary: bronchoscopic diagnosis and staging of lung cancer must be gentle and quick, and requires optimal sampling precision.electromagnetic navigation systems are promising for intraoperative guiding based on maps made of preoperative ct images. navigation accuracy depends largely on correct alignment of preoperative images to the patient´s position in space during endoscopy. in this study, the accuracy of a new fast and automatic image-to-patient registration method during the initial phase of bronchoscopy is assessed in patients referred for lung cancer investigation.

this is an accuracy study of a new automatic ct-to-patient registration technique for bronchoscopy and endobronchial ultrasound bronchoscopy (ebus). an in-house research and development navigation platform displays the intraoperative position of the endoscope inside the airways, and shows its exact position in three-dimensional (3d) maps made from the patients' own preoperative ct images. the navigation system is used for acquiring position data from a bronchoscope or ebus-scope (same sort of output data acquired from both endoscopes in this study) equipped with a position sensor for electromagnetic tracking. from intraoperative position data, the accuracy of the image-to-patient registration and the navigation system accuracy can be calculated. when targeting a certain lymph node or tumor for sampling, the pulmonologist can use electromagnetic navigation combined with preoperative ct images to navigate directly, precisely and accurately to the area of interest. functional systems for navigated bronchoscopy and ebus may therefore lead to considerable improvements in lung cancer diagnosis and mediastinal staging.

Eligibility criteria:
inclusion criteria: * referred to thoracic department st olavs hospital due to suspicion of lung cancer * informed consent exclusion criteria: * pregnancy

Keywords: bronchoscopy bronchoscopes
a multicenter phase ii double-blind exploratory study to evaluate differences among various zidovudine/didanosine regimens on quantitative measures of viral burden in relatively early hiv-1 infection

Conditions: HIV Infections

Summary: to determine the relative antiviral activity and safety of zidovudine ( azt ) and didanosine ( ddi ) alone and in combination, as well as in various sequences of administration. the relative efficacy of the approved antiretrovirals in early hiv-1 disease is unclear; thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity.

the relative efficacy of the approved antiretrovirals in early hiv-1 disease is unclear; thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity. patients undergo observation for 2 weeks, then are randomized to one of six treatment arms to receive ddi alone or in sequence or combination with azt for 16-32 weeks, followed by 4 weeks of post-treatment evaluation. the regimens are: ddi alone for 32 weeks; azt for 16 weeks followed by ddi for 16 weeks; azt for 16 weeks followed by azt/ddi combination for 16 weeks; ddi for 16 weeks followed by azt for 16 weeks; azt/ddi combination for 32 weeks; and placebo for 32 weeks. per amendment 6/18/96: note: patients enrolled under version 3 of the study will terminate treatment at week 16 and have a 4 week follow up.

Eligibility criteria:
inclusion criteria patients must have: * hiv-1 seropositivity. * cd4 count \>= 550 cells/mm3. * asymptomatic disease. * no prior antiretroviral therapy. * consent of parent or guardian if less than 18 years old. per amendment 6/18/96: * patients with an undocumented history of oral candidiasis or a history of candidiasis that was antibiotic associated may enroll. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * medical condition that precludes study compliance. concurrent medication: excluded: * antiretrovirals other than study drugs. * biologic response modifiers including erythropoietin and g-csf. * systemic corticosteroids. * systemic cytotoxic chemotherapy. * intravenous pentamidine. concurrent treatment: excluded: * systemic radiation therapy. patients with the following prior conditions are excluded: * history of grade 2 or worse peripheral neuropathy. * history of pancreatitis or factors predisposing to pancreatitis. prior medication: excluded: * prior antiretrovirals. * systemic immunomodulators (e.g., gp120, gp160, il-2, interferons) within 3 months prior to study entry. chronic alcoholism.

Keywords: didanosine drug therapy, combination zidovudine drug administration schedule
monoclonal antibodies in clostridium difficile infection

Conditions: Clostridium Infection

Summary: immunoglobulin a (iga), the major mucosal antibody, plays a key role in maintaining diversity of the intestinal microbiota and eliminating intestinal pathogens. dysbiosis is an important risk factor for clostridium difficile infection, which is the leading cause of nosocomial diarrhea in industrialized countries. this study aims to develop iga monoclonal antibodies targeting c. difficile surface proteins.

immunoglobulin a (iga), the major mucosal antibody, plays a key role in maintaining the diversity of the intestinal microbiota and eliminating intestinal pathogens. they modulate microbiota composition and also commensal bacteria homeostasis, thus promoting a symbiotic relationship. these observations, derived from mouse studies, open promising therapeutic perspectives: iga could be used to restore or maintain a healthy microbiota in individuals suffering from intestinal dysbiosis. specific to a pathogen, iga can also be considered as an alternative to antibiotics by mimicking a physiological elimination. abnormalities in microbial diversity (i.e. dysbiosis) have been associated in humans with various diseases such as clostridium difficile infection, which is the leading cause of nosocomial diarrhea in industrialized countries. the incidence of cdi has dramatically raised since the early 2000s, with an increasing severity. current treatments are limited to the administration of antibiotics that unbalance the intestinal microbiota, a risk factor for relapse. these frequent relapses contribute to the severity and chronicity of the infection. this study aims to generate human iga-type antibodies targeting c. difficile surface proteins with neutralizing and/or protective activity. these antibodies will be selected against surface proteins involved in the early stages of colonization. after injection or ingestion, these iga antibodies should reproduce physiological mucosal immunity, treat severe forms and prevent the occurrence of c. difficile relapses while limiting deleterious effects on the intestinal microbiota. c. difficile-specific b cells will be selected from infected patients. after selection of the most neutralizing iga antibodies in vitro, these will be administered to c. difficile infected mice.

Eligibility criteria:
inclusion criteria: * adult patient, 18 years of age * diarrhea and/or abdominal pain. * presence of c. difficile toxins in feces * patient having dated and signed informed consent. exclusion criteria: * pregnant or nursing women * adult under guardianship * ileus * peritonitis * pseudomembranous colitis * hemodynamic instability * fever ≥ 38.5°c * shivers * respiratory failure * leukocytosis \> 15x109/l * serum creatinin \>50% reference values) * serum lactate \> 5mm * serum albumine \< 30g/l * other diarrhea cause * humoral immunodeficiency

Keywords: clostridium difficile infection therapeutic monoclonal antibodies
phase ii study of bone marrow transplantation using related donors in patients with aplastic anemia

Conditions: Aplastic Anemia

Summary: objectives: i. evaluate the efficacy of related, hla-identical bone marrow transplantation following cyclophosphamide (ctx) and antithymocyte globulin in patients with aplastic anemia. ii. evaluate the efficacy of related, hla-nonidentical bone marrow transplantation following ctx and total-body irradiation/total-lymphoid irradiation in patients with aplastic anemia.

protocol outline: patients with hla-identical donors receive cyclophosphamide/mesna, antithymocyte globulin (atg), and methylprednisolone (meprdl), followed by allogeneic marrow transplantation. patients with hla-nonidentical (5/6 or 4/6) donors and those with a systemic reaction to atg receive the same dosage of myeloablative chemotherapy and rescue. in addition, these patients are treated with total-body irradiation, total-lymphoid irradiation, and methotrexate. all patients received meprdl and cyclosporine for graft-versus-host prophylaxis.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- severe aplastic anemia with 2 of the following criteria: polymorphonuclear neutrophils no more than 0.5 x 10 to the ninth/l platelets no more than 20 x 10 to the ninth/l reticulocytes no more than 30 x 10 to the ninth/l hypocellular bone marrow related donor aged 6 weeks or more, matching at least 4 of 6 hla a, b, and dri loci, as follows: hla-identical family member for patients aged less than 40 years hla-nonidentical family member for patients aged less than 55 years failing antithymocyte globulin or other immunosuppressive therapy the following eligible for transplantation as initial therapy: patients aged less than 40 years with hla-matched donor patients aged 40-45 years with hla-identical donor no neoplastic or preneoplastic evolution --patient characteristics-- age: under 40 (55 if atg failure) hepatic: no severe liver dysfunction renal: no severe renal dysfunction cardiovascular: no severe cardiac dysfunction other: no other organ dysfunction that would compromise survival after transplant no hiv infection

Keywords: aplastic anemia hematologic disorders rare disease