Kornimate/medical-research-clean huggingface dataset:
long term follow-up of a study to assess the safety and immunogenicity of a hepatitis a vaccine administered with and in the absence of dtpahibipv, opv and mmr vaccines

Conditions: Hepatitis A

Summary: the primary purpose of this study was to assess whether the protection afforded by epaxal vaccine co-administered with diphtheria, tetanus, bordetella pertussis, haemophilus influenzae type b, and inactivated polio vaccine(dtpahibipv), oral polio vaccine (opv) and (measles mumps and rubella) mmr vaccines against hepatitis a was not inferior to the protection afforded by epaxal administered alone. the aim of the follow-up phase is to obtain information on the long term protection afforded by epaxal, and to compare this with an alternative hepatitis a vaccine (havrix).


Eligibility criteria:
inclusion criteria: original study: * written informed consent obtained from the parent/legal guardian of the subject. * free of obvious health problems as established by medical history and/or clinical examination before entering the study. * at least 8 kg of body weight at age of 12 months. follow-up phase: * subjects enrolled and randomised in the original study and having received two doses of the hepatitis a study vaccines. exclusion criteria: original study: * children not having received 3 documented doses of dtpahib and polio vaccines during infancy * children having received a documented dose of mmr during infancy * use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and the 30 days safety follow-up after the last dose. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * administration of systemic corticosteroids (inhaled and topical steroids are allowed). * administration of a vaccine not foreseen by the study protocol within 4 weeks prior to the first dose of study vaccine. * previous vaccination against hepatitis a. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * major congenital defects or serious chronic illness * acute disease at the time of enrolment. follow-up phase: * children who had received a hepatitis a antigen containing vaccine since the last visit

Keywords: hepatitis a vaccine combined vaccines dtp vaccine mmr vaccine
cortical excitability and role of rtms in cannabis use disorder

Conditions: Cannabis Use Disorder, Moderate

Summary: repetitive transcranial magnetic stimulation (rtms) and cortical excitability have a role in cannabis use disorder


Eligibility criteria:
inclusion criteria: * 18to 50 years of age * cannabis use disorder according to dsm 5 definition * clear consent to participate in study exclusion criteria: * cardiac peacemaker * metal implant in the head as participate will be applied to magnetic field of tms * current intake of any medication affect cognition (as anti psychotic and anti epileptic) * current history of neurological , psychiatric or general medical disease .current or previous drug (other than cannabis )or alcohol abuse or participation in another trial during the past 8 weeks . * age younger than 18 and older than 50 years
hiv treatment-readiness measure (htrm) validation

Conditions: HIV Infections

Summary: the goal of this study is to assess the reliability of the hiv treatment readiness measure (htrm) to assist clinicians in: (1) determining whether or not youth living with hiv are ready to initiate haart and (2) identifying youth who may be in need of additional support services to facilitate their adherence to haart. the current study will examine the psychometric properties of the htrm and establish its test-retest reliability over a two week period. if the htrm is found to be reliable, a subsequent study will examine its predictive validity.


Eligibility criteria:
inclusion criteria: * hiv-positive youth, 13 years 0 days to 24 years 364 days of age * either haart naïve (defined as never having taken haart) or haart experienced (defined as having had at least one experience taking haart and not having taken haart for 30 days prior to study entry) * not currently on haart, but planning to initiate haart within the next 2 months based on provider recommendation * enrolled in care at an amtu or a collaborating site * able to speak and understand english * willing to provide informed consent, or assent with parental permission (if required by the site irb) for participation in this study. exclusion criteria: * evidence of cognitive impairment or other mental condition that limits his/her ability to complete the assessment (per pi or designee discretion) * determined by the pi (or designee) to be under the influence of psychoactive agents or intoxicated at the time of assessment to a degree that would interfere with successful completion of the questionnaire * visibly distraught or unstable * any clinical condition that would likely interfere with the participant's ability to complete the study participants who are unable to speak english will be excluded from the initial testing of the htrm's reliability and validity in keeping with traditional tool development strategies. if the initial study indicates that the english version of the htrm is reliable and valid, appropriate methods will be employed to translate the instrument into spanish and the reliability and validity will be re-examined for the spanish version.

Keywords: hiv treatment readiness measure (htrm) highly active antiretroviral treatment (haart) adherence treatment readiness hiv
a phase 3 study of intravenous metronidazole for intrabdominal infection

Conditions: Intra-abdominal Infections

Summary: the purpose of this study is to evaluate the clinical efficacy and safety in japanese adult subjects with intra-abdominal/pelvic infections receiving metronidazole iv 1,500-2,000 mg/day in combination with ceftriaxone sodium.


Eligibility criteria:
inclusion criteria: * 16 years of age or older. * diagnosed with intra-abdominal infections or pelvic inflammatory diseases. * can be obtained a specimen for bacteriological efficacy assessment. exclusion criteria: * known or suspected hypersensitivity, intolerance or contraindication to metronidazole, ceftriaxone sodium, or other cephem antibiotics. * severe renal dysfunction (creatinine clearance \< 30 ml/min.) reference: cockcroft-gault calculation formula. * hepatic dysfunction (ast, alt, total bilirubin \> 3 times upper limit of normal range values). * severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.

Keywords: metronidazole intra-abdominal infection pelvic inflammatory disease anaerobe
post -extubation respiratory failure

Conditions: Respiratory Insufficiency

Summary: comparing high flow nasal cannula , conventional oxygen tharapy and non invasive ventilation post-extubation period for patients mechanically ventilated due to respiratory failure regarding re-intubation rate, icu outcome \& 28 days mortality

patients with respiratory failure either type i or type ii planned for extubation will be divided into 3 groups post extubation : group i: will receive high flow nasal cannula giving oxygen 60 litres / minute flow group ii: will receive nasal cannula up to 10 litres / minute group iii: will receive non invasive ventilation data of the patients will be collected for 28 days post-extubation and analysed

Eligibility criteria:
inclusion criteria: * respiratory failure type i and type ii exclusion criteria: * mechanical ventilation due to other cause such as disturbed conscious level or respiratory muscle weakness
evaluation of a combined model in predicting weaning outcome in critically ill patients.

Conditions: Weaning Failure

Summary: the purpose of our study is to assess lung aeration and diaphragmatic indices by transthoracic ultrasonography in patients ready to be weaned from mechanical ventilation as predictors of weaning success

assessment of lung aeration and diaphragmatic indices by transthoracic ultrasonography in patients ready to be weaned from mechanical ventilation as predictors of weaning success in critically ill patients .

Eligibility criteria:
inclusion criteria: * patients more than18 years old. * all patients intubated and requiring mechanical ventilation for 48 hours or more at respiratory intensive care unit (ricu) * patients fullfiled the criteria of readiness to wean according to european respiratory society guidelines (ers) exclusion criteria * patients with neuromuscular disease or diaphragmatic paralysis. * patients with tracheostomy. * patients who undergone surgical operations especially abdominal and thoracic operation. * patients with diseases that may affect the diaphragm (including pneumothorax, pneumomediastinum, patients with inserted intercostal tube (ict), third trimester of pregnancy).

Keywords: lus dus rsbi
electrochemotherapy (ect) in patients with primary visceral tumors and/or secondary visceral localizations, of any histotype

Conditions: Primary Visceral Tumors of Any Histotype; Visceral Lesions; Liver Cancer; Liver Metastasis Colon Cancer; Melanoma; Primary Pancreatic Tumor; Retroperitoneal Sarcoma; Abdominal and/or Peritoneal Localizations; Merkel Cell Carcinoma; Squamous Cell Carcinoma; Secondary Visceral Localizations of Any Histotype; Non-melanoma Skin Cancer

Summary: this is an monocenter, single arm, clinical investigation that evaluate the impact of the method on the objective response rate (orr) of visceral lesions undergoing electrochemotherapy. electrochemotherapy is a well-defined method for the treatment of cutaneous and subcutaneous metastases of different tumor histotypes. although still limited, the various experiences in the treatment of visceral localizations, particularly in liver metastases from colorectal cancer are promising and show that electrochemotherapy is a safe treatment, even in the case of lesions near large vessels or nerves. the investigators therefore propose a clinical investigation with a medical device according to eu regulation 745/2017, using electrochemotherapy (cliniporator) with bleomycin for the treatment of visceral, primary or secondary, unresectable localizations, with percutaneous or intraoperative technique (laparoscopic or laparotomy), as needed.

this is a single-center clinical investigation with the enrollment of at least 24 patients with visceral, primary or secondary localizations, of any histotype, with particular reference to liver cancer, liver metastases from colorectal cancer and melanoma, primary pancreatic tumors, retroperitoneal sarcomas, abdominal and/or peritoneal localizations from melanoma and non-melanoma skin cancer (merkel cell carcinoma, squamous cell ca).

Eligibility criteria:
inclusion criteria: * male/female ≥ 18 years * ability to understand the proposed treatment and express an informed acceptance by signing the informed consent * diagnosis of primary and/or secondary visceral localizations of any histotype * patients who are not eligible for standard curative procedures exclusion criteria: * absolute contraindications to invasive procedures * concomitant presence of brain, lung, bone metastases * uncorrectable coagulation changes * bleomycin allergy * absolute contraindications to taking bleomycin * poor respiratory function or pulmonary fibrosis * acute lung infections * is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study

Keywords: electrochemotherapy visceral lesions laparoscopic procedure laparotomic procedure percutaneous procedure bleomycin medical device
sleep thermography for diagnosis of obstructive sleep apnea (termoapnea)

Conditions: Obstructive Sleep Apnea (OSA)

Summary: to assess the diagnostic validity and cost-effectiveness of an infrared thermography system in adults with clinical suspicion of obstructive sleep apnea (osa).

aims: to assess the diagnostic validity and cost-effectiveness of an infrared thermography system, integrated in an expert diagnostic algorithm (tis), to determine the sleep stages and identify respiratory events, compared to conventional polysomnography (psg) in adults with clinical suspicion of obstructive sleep apnea (osa). metodology: design: prospective, unicentric, randomized and blinded study carried out into two phases: phase i: development of the tool in 99 full valuable adults with suspected osa (psg recruitment, coordination and quality control, image capture, information and development of the expert system); phase ii: validation of the tool compared with the psg in another group of 99 full valuable adults with suspected osa. instrumentalization: a) clinical history and anthropometric variables; b) sleep and quality of life questionnaires; c) psg; d) tis; e) cost-effectiveness study. analysys : the validity of the results of the tis will be analyzed compared with the results of the psg. the agreement measure will be established according to the different categories of the apnea-hypopnea index (ahi), using roc (receiver operating characteristic) curves and the area under the curve. the investigators will also validate the therapeutic decisions made with psg compared to those performed with the tis. finally, a cost-effectiveness study will be performed.

Eligibility criteria:
inclusion criteria: * men and women over 18 years to 75 years old, with clinical suspicion of osa * written informed consent signed exclusion criteria: * place of residence more than 100 km from the hospital * severe, unstable or exacerbated cardio-vascular, cerebro-vascular or respiratory disease, that makes it impossible to carry out adequate studies * presence of insomnia, depressive syndrome or epilepsia * patients diagnosed of any acute inflammatory episode of the cranium-maxillo-facial area or any systemic infection that develops with fever\> 38 ºc at the time of testing * patient with malformation syndromes, down syndrome and neuromuscular diseases * patient on active treatment with positive continuous pressure (cpap )

Keywords: infrared thermography system standard polysomnography validity cost-effectiveness
transversus abdominis plane block in the analgesia of acute pancreatitis

Conditions: Pancreatitis, Acute

Summary: background severe abdominal pain is a hallmark of acute pancreatitis (ap). a control pain is often difficult. transversus abdominis plane (tap) block has been used in pain control in patients with exacerbation of chronic pancreatitis. objectives to evaluate the effect of bilateral blockade of the abdominal transverse muscle plane (tap block) in the analgesic control of patients with acute pancreatitis; compared to standard intravenous analgesia. methods a randomized controlled trial of parallel groups will be conducted. the study will have a multicenter development. study population: adult patients admitted for episode of ap, with uncontrolled pain (visual analogue scale (vas) equal to or greater than 5 after the administration of standard analgesia. randomization groups: group a: patients who will undergo tap block as analgesic procedure added to standard analgesia. group b: patients to whom morphine 2 mg / ev will be administered as analgesic procedure added to standard analgesia. timing of pain determination (visual analogue scale, vas): * before conventional analgesia * immediately before randomization * 15 minutes after the administration of the analgesic treatment object of the study. * one hour after the procedure. * every 8 hours, during the next 4 days or until discharge of the patient. * whenever the patient needs a dose of supplemental rescue analgesia. analysis of data all results will be evaluated according to the initial "intention to treat". there will be a blinded assessment of the results after the last patient in the trial has completed the follow-up. the results will be presented as relative risks with their corresponding confidence intervals. p \<0.05 will be considered statistically significant. in case of imbalance between the two treatment groups, a multivariate logistic regression is used to correct possible confounding factors.


Eligibility criteria:
inclusion criteria: * diagnosis of acute pancreatitis according to modified atlanta criteria . * patients with the ability to understand the vas scale and express their level of pain. * patients over 18 years old. * uncontrolled pain, with vas ≥ 5 after the administration of standard analgesia. * material and technical possibility of performing the tap technique immediately after randomization. * informed consent of the participating patients for inclusion in the study. * informed consent of the participating patients for the administration of tap. * normality of coagulation levels exclusion criteria: * patients with american society of anaesthesia (asa) levels iv and v * patients with chronic pancreatitis * pregnancy * patients with chronic treatment with morphic medication
safety and immunogenicity study of a diphtheria, tetanus, acellular pertussis and poliomyelitis vaccine (repevax) followed by 2 doses of a diphtheria, tetanus and poliomyelitis vaccine (revaxis) in subjects of 40 years of age or older

Conditions: Diphtheria; Tetanus; Poliomyelitis; Pertussis

Summary: primary objective: * to demonstrate that 3 doses of a vaccine containing td-ipv valences administered in a 0, 1 and 6-month schedule induce an acceptable immune response in terms of seroprotection rates (spr) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years * to evaluate the percentage of subjects with antibody titre ≥5 eu/ml (elisa) for each of the pertussis components (pt, fha, prn and fim) after 1 dose of repevax in these subjects secondary objectives: * if the primary objective is achieved, to determine whether 1 or 2 doses of a vaccine containing td-ipv valences induce an acceptable response in terms of seroprotection rates (spr) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years * to describe the immune responses to repevax in these subjects * to describe the immune responses to revaxis administered 1 and 6 months after the administration of repevax in these subjects


Eligibility criteria:
inclusion criteria: * adults aged ≥40 years * no receipt of a booster dose with a tetanus-, diphtheria-containing vaccine within the last 20 years exclusion criteria: * medically diagnosed pertussis disease within the last 10 years * receipt of medication / vaccine that may interfere with study assessments * febrile illness or moderate or severe acute illness/infection * know pregnancy * history of hypersensitivity or anaphylactic or other allergic reactions to any of the vaccine components, or history of a life-threatening reaction to the study vaccines or a vaccine containing any of the same substances * history of guillain barré syndrome or brachial neuritis following a previous vaccination * history of encephalopathy of unknown origin within 7 days after immunization with a pertussis-containing vaccine or neurological disorders * known or suspected immune dysfunction * thrombocytopenia, bleeding disorder or anticoagulants contraindicating intramuscular vaccination * chronic disease or intercurrent illness that might interfere with study assessments

Keywords: diphtheria tetanus poliomyelitis pertussis (acellular) biological/vaccine
enhanced spanish drug label study to promote patient understanding and use

Conditions: Medication Understanding; Diabetes; Hypertension

Summary: the overall objective of this study is to test the efficacy of an evidence-based, enhanced rx container label design to improve spanish speaking patients' understanding of instructions for use.

the investigators will conduct a randomized controlled trial (n=960) to evaluate the efficacy of the enhanced rx container label to improve, spanish speaking, diabetic and/or hypertensive patients' understanding of actual prescribed medicines, compared to a standard label format. spanish-speaking patients with type ii diabetes and/or hypertension at safety-net clinics affiliated with one central-fill pharmacy (nova scripts central - nsc) receive all their prescribed medicines from this location. recruited diabetic and/or hypertensive subjects in this study will be randomly assigned to either intervention (enhanced rx container label) or control (standard rx label). all pill-form, regular dosing schedule medicines, including diabetes and hypertensive (i.e. ace inhibitor) medicines associated with patients' treatment will be labeled according to study arm by the central-fill pharmacy. study subjects will be interviewed at the time of dispensing the prescribed medicines at the clinic, again three months later (dispensing of refill), and finally nine months after baseline (dispensing of refill). pharmacy refill data and medical record information - linked at these clinics - will be collected for exploratory analyses. patients' ability to read and demonstrate rx label instructions, including auxiliary warnings, will be the primary outcomes for this aim. data from the actual use trial will be processed, reviewed, analyzed (in order of hypotheses), and reports prepared during the final months of this last phase of the study. we anticipate several manuscripts to be developed as a result of this project, supported by the diverse key personnel and collaborating faculty enlisted.

Eligibility criteria:
inclusion criteria: * diagnosis of type ii diabetes or hypertension in their medical chart * spanish speaking * 30 years or older exclusion criteria: * uncorrectable hearing or visual impairment. * too ill to participate
idiopathic hypertensive anal canal: a place of internal sphincterotomy

Conditions: Hypertensive Anal Canal

Summary: idiopathic hypertensive anal canal is a fact and already exists presented by anal pain aggravated by defecation. it can be managed safely by closed lateral sphincterotomy but chemical sphincterotomy had a minor role in its management.

patient and methods: sixty three patients complaining of anal pain without any anal pathology and 10 healthy volunteers were examined. all patients underwent clinical evaluation, neurological examination, anorectal manometry, and measurement of pudendal nerve terminal motor latency (pntml). all patients with hypertensive anal canal were randomized into three groups. group i (surgical group) underwent closed lateral sphincterotomy ls, group ii using nitroglycerine ointment (gtn) and group iii received injection of botulinum toxin in internal sphincter. post procedures data were recorded at follow up period.

Eligibility criteria:
inclusion criteria: * all patients with hypertensive anal canal exclusion criteria: * patients who had any pathological anorectal lesions such as anal fissure, piles, rectal prolapse, intussusception, anismus, cancer, patients with normal anal pressure * patients who previously had anorectal surgery, chemical or surgical sphincterotomy, anal dilatation, ibd, venereal disease, neurological disorder or systemic gastrointestinal disease

Keywords: anal hypertonia sphincterotomy incontinence manometry