Kornimate/medical-research-clean huggingface dataset:
a study to assess the ability of 2% lidocaine gel to reduce the discomfort of urethral catheterization

Conditions: Urinary Tract Infection

Summary: children 0-24 months of age requiring a urethral catheterization for urine collection will be randomized to receive either topical and intraurethral 2% lidocaine or standard of care to assess for the effectiveness of the former in minimizing pain during urethral catheterization. it is hypothesized that administration of 2% lidocaine gel both topically and intraurethrally will confer a greater degree of pain reduction compared to standard of care.

an estimated 10% of children 0-24 months of age that present to the emergency department (ed) with fever and/or vomiting have a urinary tract infection (uti). an accurate diagnosis of a uti ensures timely and appropriate treatment given to reduce the risk of renal scarring, which is the greatest in this age group. to ensure diagnostic accuracy, urethral catheterization is the preferred method to obtain a urine sample from a young child. in contrast to adults, most children do not receive local analgesia for urethral catheterization; despite growing recognition that children experience avoidable pain and discomfort during invasive procedures. following informed consent, participants will be randomized by block randomization in a concealed fashion to receive either topical and intraurethral 2% lidocaine or standard of care using a computerized random number generator. the research nurse will access a sequentially numbered, opaque sealed envelope that will contain the participant's group assignment. no adjunctive analgesic methods will be used. a research pharmacist will prepare 2% lidocaine gel in a 3 cc syringe attached to a 24 gauge angiocath. children \ 7 kg will receive 1 cc and 1.5 cc, respectively (2). the entire procedure will be videotaped and participants pain will be scored using a brow bulging score and visual analogue scale by independent, blinded raters.

Eligibility criteria:
inclusion criteria: * children 0-24 months of age presenting to the emergency department requiring a urethral catheterization to obtain a urine specimen exclusion criteria: * unstable * external genitourinary anomalies * lidocaine allergy and * previous catheterization within 24 hours

Keywords: urethral catheterization lidocaine
natesto testosterone nasal gel for hypogonadal men

Conditions: Erectile Dysfunction; Sexual Dysfunction

Summary: to determine if testosterone deficient men who are using daily tadalafil (a phosphodiesterase-5 inhibitor), will have a significant improvement in erectile function and satisfaction with erectile dysfunction treatment when using on-demand testosterone nasal gel (tng) prior to sexual activity compared to placebo.

the purpose of this study is to determine if testosterone deficient men whose primary symptom is erectile dysfunction, who are using daily tadalafil (a phosphodiesterase-5 inhibitor), will have a significant improvement in erectile function and satisfaction with erectile dysfunction treatment when using on-demand testosterone nasal gel (tng) prior to sexual activity compared to placebo.

Eligibility criteria:
inclusion criteria: * ability to understand and provide written informed consent for the study. * ability to read and complete electronic questionnaires in english. * adult males between the ages of 18-64 years * mild-moderate ed based on shim score between 8-21 at study entry * ability to take daily tadalafil * ability to undergo venipuncture * ability to provide ejaculated semen sample * stable female sexual partner with sexual activity at least 1-3 times/month * hypogonadism defined as two (one done as soc within the last 6 months and one done at the time of screening) early morning total testosterone lab values \<300 exclusion criteria: * morbid obesity - bmi \>35 * history of diabetes (hba1c \>6.0) * hematocrit \ 54% at study entry * concurrent or prior use of other exogenous testosterone or hormone therapy (serm, aromatase inhibitor, gonadotropins) within the last 3 months. * concurrent use of other prescription medications for ed including pde5 inhibitors, intracavernosal injection therapy, urethral suppositories * concurrent use of nitrates in any form * history of pelvic radiation * spinal cord injury * any progressive neurologic disease (alzheimer's, parkinson's, multiple sclerosis, etc). * history of penile prosthesis * history of prostatectomy * history of transurethral resection of prostate * history of stroke or myocardial infarction within the past 6 months * history of congestive heart failure * history of untreated obstructive sleep apnea * history of liver disease (serum transaminases \> 2.5 times upper limit of normal) * history of chronic kidney disease (gfr\ 2) * history of, current or suspected, prostate (abnormal dre or elevated psa \>4.0) or breast cancer. * history of azoospermia or oligospermia (\<15 million/ml) * history of vasectomy * history of priapism * history of polycythemia vera * receipt of any investigational product within 4 weeks of study enrollment * recurrent upper respiratory or sinus infection (\>3 times/month for \>6 months) * recurrent epistaxis (\>3 times/month for \>6 months)
effectiveness of electro neuro adaptive regulator in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: background: there is evidence linking conditioned pain modulation (cpm) deficiency with musculoskeletal pain syndromes such as fibromyalgia, evidence shows that different physical therapies could activation situations of chronic pain there is no activation of cpm. objectives: the purpose of this study is to measure the cpm response and determine whether electro neuro adaptative regulator in patients with fibromyalgia is effective in the improvement of cpm, ts, pain intensity, disability. design: double-blind, randomized placebo clinical trial. methods: patients with fibromyalgia will be randomly allocated into two groups: the electro neuro adaptative regulator group (scenar) or the sham technique (st) group. main outcomes measures: pain intensity (with visual analogue scale, conditioned pain modulation (cpm), temporal summation (ts) and pressure pain thresholds (ppt´s) were the primary outcomes and will be assessed at baseline and at 3-months follow-up. secondary outcome measures were the fibromyalgia impact questionnaire to measure disability, pain catastrophizing scale and the pain anxiety symptoms scale, beck depression inventory, jenkins sleep scale. questionnaire of quality of life sf36. participants will be selected if they met the following inclusion criteria: (a) fulfilled the 1990 and 2010 american college of rheumatology classification criteria for fm; (b) reported an average pain intensity ≥ 4 on a 0 to 10 cm visual analogue scale during the previous week to study commencement; (c) were on stable doses of medication for fm ≥ 4 weeks; and (d) were aged between 18 and 65 years.


Eligibility criteria:
inclusion criteria: 1. . american college of rheumatology classification criteria for fibromyalgia. 2. . reported average pain intensity ≥ 4 on a 0 to 10 cm visual analogue scale based on 1 week of daily pain diaries; 3. on stable doses of medications for fm ≥ 4 weeks. exclusion criteria: * patients will be excluded from enrolment if: (1) they suffer from an inflammatory rheumatic conditions; (2) have a planned elective surgery during the study period; (3) have ongoing unresolved disability claims; (4) experience symptoms of bipolar disorder, major depressive disorder, panic disorder, or psychosis; (5) do not speak spanish fluently.

Keywords: visual analogue scale conditioned pain modulation disability pressure pain threshold temporal summation
predictive factors for chronic rejection in lung transplant recipients: colt study

Conditions: Chronic Rejection; Lung Transplantation

Summary: obliterative bronchiolitis (ob) is the major cause of long-term lung allograft loss for patients with end stage pulmonary diseases like cystic fibrosis. numerous cells and proteins are implicated in this process, which have never been studied prospectively in a multicentric longitudinal cohort. the aim of this study is to detect predictive risk factors of ob through a national multicentric cohort of 500 newly transplanted recipients (colt). colt will consist in a large database, associated with a recipient bio-collection, and specific projects using these resources. colt will aggregate all the 11 french centres of pulmonary transplantation. patient will be followed-up during 5 years. blood samples will be obtained. induced sputum, bronchoalveolar lavage fuid, exhaled breath condensate and trans bronchial biopsies will be also taken. t cells, known to be involved in chronic rejection will be studied, and genomic, microarray and proteomic approaches will be used to detect further predictive factors. a study on circulating endothelial cells and circulating endothelial progenitors is also realised from blood samples. colt will prove molecular markers to be predictive of early ob, before the development of severe airway obstruction and will allow the identification of patients at high risk of ob. colt will identify potential targets for future treatments of ob. this collaborative project makes research and clinical teams working together, and creates the conditions of a long term network, extendable to other laboratories with new projects and additional european transplant centres.


Eligibility criteria:
inclusion criteria: * male or female adults aged ≥ 18 years * who have signed an inform consent form * double or heart-lung transplant recipients exclusion criteria: * pregnant or nursing women * patients with concomitant chronic inflammatory disease, independently of acute or chronic rejection or infection

Keywords: lung transplantation chronic lung rejection obliterative bronchiolitis predictive factors
design and implementation of the pediatric liver transplantation biobank

Conditions: Liver Diseases; Liver Transplant; Complications; Pediatric ALL

Summary: the purpose of the pediatric liver transplant biobank is to systematically collect clinical specimens from pediatric end-stage liver disease. it is expected to contribute to the research and development of paediatric end-stage liver disease in the future.


Eligibility criteria:
inclusion criteria: 1. children diagnosed with end-stage liver disease. 2. liver transplantation in our hospital. 3. informed patient consent. 4. long-term follow-up in our hospital. exclusion criteria: no fixed contact information, difficult to follow up the patients.
lactobacillus bifidobacterium v9(kex02)improving the efficacy of carilizumab combined with platinum in non-small cell lung cancer patients

Conditions: Non-small Cell Lung Cancer

Summary: human microbes have been called "the second genome of humanity".on may 13,2016,the white house launched the national microbiome initiative (nmi), with an estimated investment of us $521 million, to elevate microbiome research to a national strategic status. the gut is the largest microecological environment in the human body. the research in the field of intestinal microbiome has become one of the most advanced and hot research directions in the scientific field of the world today. at present, more than 50 diseases have been found to be related to intestinal microbiome disorders. pd-1 (programmed death receptor 1) is an important immunosuppressive molecule.it regulates the immune system and promotes tolerance by down-regulating the immune system's response to human cells and by suppressing t cell inflammatory activity. in the past, the research team and colleagues in related fields have found a strong correlation between gut microbiome and the efficacy of anti-pd-1 immunotherapy in cancer patients.this protects against autoimmune diseases, but it also prevents the immune system from killing cancer cells. as more and more scientific evidence shows that intervention of human intestinal flora may improve the efficacy of anti-pd-1 immunotherapy in tumor patients, intestinal flora, as the most effective way to intervene human intestinal flora, has been mentioned by many research institutions and international drug manufacturers in combination with anti-pd-1.our previous study showed that the abundance of beneficial bacteria such as lactic acid bacteria, bifidobacteria and akkermansia muciniphila was significantly correlated with pd-1 inhibitor response, and regulating the intestinal flora content could improve the effect of pd-1 inhibitor on mouse tumors, indicating that microbial flora was involved in regulating cancer immunotherapy.


Eligibility criteria:
inclusion criteria: * karnofsky score ≥90 in patients receiving immunotherapy for non-small cell lung cancer at our cancer center exclusion criteria: * any immune system disease under high risk to antimicrobial agents such as diabetes,infection disease or drug allergy to v9
correlative biomarker study in patients with myeloproliferative disorders

Conditions: Myeloproliferative Disease; Myelofibrosis; Idiopathic Myelofibrosis; Essential Thrombocythemia; Polycythemia Vera

Summary: researchers will use abnormal blood and/or bone marrow cells, or materials derived from these abnormal cells, like dna, rna, protein or plasma, in laboratory studies. toenail clippings will provide normal material like dna for comparison with the abnormal material derived from the blood and/or bone marrow. the results of these studies will be correlated with subjects' disease symptoms and response to their experimental treatment. the mpd-rc researchers are interested in studying molecules from the blood and bone marrow, the exact molecules changing over time with the investigators choosing only the most promising for investigation. the investigators are attempting to better understand the causes of mpd and to develop improved methods for the diagnosis and treatment of these diseases. these syndromes carry a high risk of developing leukemia. it is important to continue to learn more about these blood cancers and to learn more about the effectiveness and potential side effects of various treatments. it is believed that further basic knowledge about these cancer cells as well as the effects of treatment will lead to the improvement of current therapies and the development of entirely new treatments for these diseases. the mpd-rc is hoping to determine if a number of laboratory tests (biomarkers) will allow for the prediction of response in future patients to the treatment they would receive.


Eligibility criteria:
inclusion criteria: * patients are to be registered to this study if they meet the eligibility criteria for one of the mpd-rc treatment protocols linked to this study. * patients diagnosed with the following myeloproliferative disorders including: polycythemia vera (pv), idiopathic myelofibrosis (im), and essential thrombocythemia (et) who are participating in treatment protocols of the mpd-rc are eligible. * patients must have signed an informed consent to participate in a myeloproliferative disorders research consortium (mpd-rc) treatment study to which this protocol is a companion study. the subject must also have signed a consent to participate in this mandatory companion study. exclusion criteria: see inclusion criteria.

Keywords: myeloproliferative disease myelofibrosis idiopathic myelofibrosis essential thrombocythemia polycythemia vera biomarkers philadelphia chromosome negative clonal hematopoietic malignancies
spectrum, profile and outcome of infections in patients with cirrhosis and/ or acute on chronic liver failure

Conditions: Cirrhosis; Acute Liver Failure; Chronic Liver Failure

Summary: after successful screening diagnosis of cirrhosis and/or acute or chronic liver failure will be made. these patients will undergo detail clinical, biochemical and microbiological examination at baseline. clinical examination and biochemical evaluation will be done daily and signs of infection will be noted. patients will undergo microbiological screening for infection every 48 hours. patients suspected or diagnosed to be suffering from infections will be treated as per ilbs (institute of liver and biliary sciences) antibiotic policy. site and etiology (bacterial and/or fungal) of infections will be noted in all patients at admission in liver specialty icu (intensive care unit) and during the icu (intensive care unit) stay. all the patients will be followed until discharge or death in icu (intensive care unit).


Eligibility criteria:
inclusion criteria: * a clinical, radiological or histological diagnosis of cirrhosis and/or aclf (acute on chronic liver failure). * age \> 18years exclusion criteria: * previous liver transplantation. * patients who died within 8 hours of icu (intensive care unit) admission. * acute liver failure * lack of consent * patient on steroids/ or any other immunosuppressive medication

Keywords: acute on chronic liver failure (aclf),cirrhosis, institute of liver & biliary sciences (ilbs)
effects of carbohydrate in diet and supplements on the gastrointestinal tolerability of lik066

Conditions: Obesity

Summary: the purpose of this study was to determine if lik066 taken with a meal containing low carbohydrate is associated with less diarrhea compared to a high carbohydrate meal and to assess the potential effects of supplements such as psyllium or calcium carbonate on alleviating diarrhea associated with lik066.


Eligibility criteria:
inclusion criteria: * obese and overweight, bmi 25-50, hba1c \<10% exclusion criteria: * preexisting, clinically significant cardiovascular, liver, renal, or gi disease that is considered unstable; pregnancy, type 1 diabetes; other protocol-defined inclusion/exclusion criteria may apply

Keywords: obesity overweight body mass index bmi diarrhea
efficacy and safety of hcp1102 capsule

Conditions: Asthma With Allergic Rhinitis

Summary: efficacy and safety of hcp1102 capsule : a randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.


Eligibility criteria:
inclusion: * age≥15 * mild or moderate asthma patients with allergic rhinitis * patient who meet all criteria of rhinitis * patients understood the contents and purpose of this trial and signed informed consent form * patients who are capable and willing to write subject diary * patients who agree with maintain same environment during clinical trials exclusion: * nonallergic rhinitis * severe asthma * other pulmonary disease (pulmonary tuberculosis, copd) except asthma * medical history of hypertrophic cardiomyopathy, cancer, renal disease, liver disease, cardiovascular disease, respiratory disease, endocrine disorder, cns disorder that effect safety * medical history of gastrointestinal surgery or gastrointestinal disorders that effect drug absorption * alcohol abuse or drug abuse * genetic factor of galactose intolerance or lapp lactase deficiency or glucose-galactose malabsorption * pregnant or breast-feeding women or men/women of childbearing age that they don't use contraceptives * patient who administered other investigational products within 30 days * current smoker judged to be inappropriate for the study by the investigator after reviewing other reasons

Keywords: asthma allergic rhinitis
study to evaluate music therapy on irritability and impulsivity in patients with huntington's disease (music-hd)

Conditions: Huntington Disease

Summary: the study is an open-label clinical trial evaluating whether music therapy combined with conventional management reduces irritability and impulsivity in 15 patients with early-stage huntington's disease. this pilot study aims to show the interest of alternative non-pharmacological measures such as a digital music therapy tool, adapted to an audience of huntington's patients, to help manage the psychobehavioral symptoms frequently observed in this affection, and to avoid breakdowns due to caregiver exhaustion.

the participants will be recruited at the clinical investigation center (cic) of the university hospital of poitiers and will receive music therapy for 3 months. after the start of the musical intervention, 3 visits (at 1 month, 3 months and 6 months) will be performed by practitioners, nurses and neuropsychologist at the cic. participants will answer questionnaires : irritability (bite and pba-s sub-score), impulsivity (upps-p and delay discounting task), anxiety (stai-y and ham-a), and quality of life: h-qol-i. caregivers will be asked to rate the patient's irritability and anxiety using a lickert scale from 0 to 10, and the patient's impulsivity with the isdc.

Eligibility criteria:
inclusion criteria: * age \>= 18 years * huntington disease genetically confirmed by the presence of at least 35 repeats of the cag triplet in exon 1 of the htt gene * uhdrs (unified huntington's disease rating scale) score \<= 5 with a diagnostic confidence score =4 * absence of significant cognitive impairment moca \>=24 * stable drug therapy in the 28 days prior inclusion and during the study * without legal tutors or subordination * affiliated to a health insurance system as required by the french law on biomedical research * written informed consent for participation in the study exclusion criteria: * inability to give free and informed consent for study participation * significant hearing impairment * participating to another study the day of enrollement * persons benefiting from enhanced protection, i.e.persons deprived of their liberty by a judicial or administrative decision, adults under legal and finally patients in a vital emergency situation.

Keywords: music therapy irritability impulsivity
gut associated lymphatic tissue (galt) in hiv (human immunodeficiency virus)- infected patients

Conditions: HIV Infection

Summary: to date, despite the known benefits of antiretroviral therapy (art), many hiv-infected people are presenting late with very low cd4+ t-cells levels below 350/ul. these patients are more likely to be diagnosed with opportunistic infections, their risk of death is higher and their rate of immunological improvement is slower (mussini c et al., 2008). these patients often present a real challenge due to their advanced clinical status (borghi v et al., 2008). unfortunately, little is known about the clinical presentation of these patients, their responses to antiretroviral treatment and especially about the changes in the adaptive and innate immunity of the galt.

the investigator proposes to evaluate the virological, immunological and clinical outcomes of art in hiv-1 infected 'late presenters'. the investigator further wants to investigate the longitudinal dynamics of the innate and adaptive immunity restoration in the galt and peripheral blood of hiv infected patients under art. in particular the investigators want to longitudinally assess dcs, nk-cells, cd4+ t-cells und cd45ro+-t-cells as well as the levels of ifnγ, ifnα, tnfα, and il-12 in the galt and peripheral blood by flow cytometry and by real-time pcr and correlate these data with laboratory and clinical parameters. the investigators expect that this longitudinal study and experiments outlined in the protocol will provide valuable information about several important issues of the clinical outcome of patients under art as well as understanding immunopathology during hiv-infection.

Eligibility criteria:
inclusion criteria: * documented hiv infection * patients naive to antiretroviral treatment * age older than 18 years * indication for initiation of art * informed consent exclusion criteria: * patients on antiretroviral treatment * no informed consent * estimated life expectancy \<1 year * age \<18 years

Keywords: hiv galt