Kornimate/medical-research-clean huggingface dataset:
transcricoid injection vs. spray as you go method for local anaesthesia during bronchoscopy

Conditions: Pulmonary Disease

Summary: flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various bronchopulmonary diseases. most patients tolerate the procedure well although cough is often reported as a distressing symptom. it is likely that the acceptance of bronchoscopy would be significantly improved with control of cough. use of sedation during bronchoscopy has been reported to improve procedure tolerance. however, awake(no sedation) bronchoscopy is routinely performed at many centres including ours. topical lignocaine is administered during bronchoscopy for local anaesthesia. there is limited literature on the efficacy of transtracheal/transcricoid injection versus spray as you go method for lignocaine delivery to the airways during bronchoscopy. this study would help to determine the procedure comfort for the patient while using the transtracheal/transcricoid method vs the spray as you go method.

for all patients meeting the inclusion criteria, the demographic profile including age, sex, weight, smoking history and the type of procedures performed during bronchoscopy shall be recorded. a written informed consent will be obtained from all participants. the patients who undergo flexible bronchoscopy would be randomised in a one is to one ratio either to transcricoid or spray as you go group. prior to the bronchoscopy blood pressure, pulse rate, respiratory rate and pulse oximetry saturation will be recorded at the baseline patients in both the groups shall be prepared in a similar fashion except for the initial route of lignocaine delivery. during the procedure, 1.5 ml aliquots of 2% lignocaine solution will be delivered through the bronchoscope when using spray-as-you go technique. patients in the transcricoid group shall initially receive 5 ml of 2% lignocaine solution instilled transtracheally along with two baseline 1.5 cc bronchial spray aliquots of lignocaine, and additional aliquots of 2% lignocaine using the spray as you go method. the total lignocaine dose during the procedure will be recorded. the patients would be monitored for any adverse effects throughout the procedure. the bronchoscopist doing the procedure will be provided 2 vas charts to mark the severity of cough and overall procedure satisfaction. cough count shall be noted.

Eligibility criteria:
inclusion criteria: * indication for diagnostic or therapeutic flexible bronchoscopy * age \> 18 years * hemodynamic stability (defined as systolic bp \>100 mm hg and, \<180 mm hg). exclusion criteria: * refusal of consent * known documented hypersensitivity to lignocaine * procedure performed under general anaesthesia * pregnancy * hypoxemia (oxygen saturation \[by pulse oximetry\] \< 92% with fio2 of ≥ 0.3 * bronchoscopy done through endotracheal or tracheostomy tube * midline neck mass or thyroid enlargement making the identification of cricothyroid membrane difficult' * patients with central airway obstruction * patients with active ongoing hemoptysis

Keywords: bronchoscopy lignocaine
schizophrenia and ptsd project: health, interventions, and risk/resilience evaluation(sapphire study)

Conditions: Schizophrenia; PTSD

Summary: we propose to establish a database characterizing the presence or absence of comorbid ptsd in veterans with schizophrenia or schizoaffective disorder (sad) receiving services at the durham va medical center. in addition to the evaluation of ptsd symptoms in veterans with schizophrenia or sad, this database will facilitate the investigation of a number of additional specific research questions relevant to veterans with psychotic disorders.

see brief summary

Eligibility criteria:
inclusion criteria: 1. 18-72 years of age, any ethnic group, either sex. 2. diagnostic and statistical manual, fourth edition (dsm-iv) diagnosis of schizophrenia or schizoaffective disorder. 3. ability to fully participate in the informed consent process, or have a legal guardian able to participate in the informed consent process. exclusion criteria: 1. unstable current medical or neurological illness. 2. significant suicidal or homicidal ideation. 3. pregnant women or women who could be pregnant.

Keywords: schizophrenia ptsd cognition
broccoli, peas and pin

Conditions: Prostatic Intraepithelial Neoplasia

Summary: this is a parallel human intervention trial to determine to what extent a dietary intervention of broccoli or peas can change the expression (switching on or off) of genes in prostate tissue in men diagnosed with high-grade prostate intraepithelial neoplasia (pin).

cancer is one of the main causes of death among humans in the world. prostate cancer affects 20,000 men in the uk alone each year. diet is known to be a major factor that influences risk of cancer. therefore, changes to the diet may alter cancer risk. cruciferous vegetables, particularly broccoli, provide the diet with a substantial source of plant chemicals called glucosinolates. previous research has indicated that glucosinolates break down to form isothiocyanates (itcs) that can be absorbed in the body. further research has indicated that itcs may protect the body against the development of prostate cancer. however, the mechanisms behind this effect are not fully understood. itcs are thought to be powerful anti cancer agents as they can modulate the expression (switching on or off) of specific genes involved in the removal of toxic substances such as carcinogens from the body. in this study we wish to evaluate the effect of consumption of a conventionally bred cultivar of broccoli containing high levels of itcs on gene expression in prostate tissue to gain a better understanding of its mechanism of action. several studies suggest a further protection against cancer amongst individuals who have a deletion of certain genes. this pilot study comprises a 12-month intervention of either 400g itc-enriched broccoli per week of 400g garden peas in men at high risk of developing prostate cancer. changes in gene expression of prostate biopsy tissue will be compared before and after 6 and 12 months of intervention in both dietary groups.

Eligibility criteria:
inclusion criteria: * men with a previous diagnosis of high-grade prostatic intraepithelial neoplasia * bmi \>18.5 or \<35 * aged between 30-70 years exclusion criteria: * undergoing chemopreventive therapy * receiving testosterone replacement medicines * active infection requiring treatment * bmi \ 35 * diagnosed with diabetes * unable to give informed consent

Keywords: gene expression prostate broccoli cancer men diagnosed with high-grade prostatic intraepithelia neoplasia
intravenous acetaminophen/ibuprofen fixed-dose combination on postoperative opioid consumption

Conditions: Postoperative Pain

Summary: this prospective, randomized, double-blinded study is designed to evaluate the postoperative analgesic effect of the intravenous acetaminophen/ibuprofen fixed-dose combination in patients undergoing video-assisted thoracic surgery (vats). we hypothesize that the intravenous acetaminophen/ibuprofen fixed-dose combination can significantly reduce postoperative opioid consumption and pain severity in patients with vats.

adult patients undergoing elective unilateral vats wedge resection, segmentectomy, or lobectomy are randomly allocated to receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) fixed-dose combination (n=48) or not (n=48). at the end of induction, the intervention group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 min, every 6 hours, a total of 4 times. the control group will receive intravenous normal saline with the same volume and same time points as the intervention group receives.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo elective unilateral vats segmentectomy or lobectomy under general anesthesia * american society of anesthesiologists (asa)physical classification i-ii * consent to iv-patient controlled analgesia use * willingness and ability to sign an informed consent document exclusion criteria: * do not understand our study * allergies to anesthetic or analgesic medications * continuous local anesthetics infiltration for postoperative pain control * patients who receive mechanical ventilation more than 2 hours after surgery * pregnancy/breastfeeder * medical or psychological disease that can affect thetreatment response

Keywords: postoperative pain
safety of 4cmenb exposure during pregnancy

Conditions: Infections, Meningococcal

Summary: 4cmenb was approved by the food and drug administration (fda) in the united states in january 2015 for people aged 10 through 25 years of age. 4cmenb should be used during pregnancy only if clearly needed and sometimes, inadvertent exposure during pregnancy may also occur - before the woman knows she is pregnant, for example. the objective of this study is to evaluate the safety of 4cmenb during pregnancy and to help us learn more about the health of women who have been vaccinated with 4cmenb within 30 days prior to their last menstrual period (lmp) or at any time during pregnancy, and the health of their infants. pregnant women within the us who received at least 1 dose 4cmenb vaccine within 30 days prior to their last menstrual period or at any time during pregnancy are eligible to participate. a woman may self-enroll in the registry by calling the pregnancy registry telephone number directly or their healthcare provider (hcp) can, with their consent, enroll them on their behalf. alternatively hcps may report anonymous data on pregnancy exposures and outcomes occurring within their network/health maintenance organization (hmo). the health of the woman and her infant will be followed up until the end of the pregnancy.


Eligibility criteria:
inclusion criteria: any pregnant women within the us who received at least 1 dose 4cmenb vaccine within 30 days prior to lmp or at any time during pregnancy where: * sufficient evidence to confirm that exposure to a meningococcal b vaccine (confirmed or possible 4cmenb exposure) occurred within 30 days prior to lmp or at any time during pregnancy * sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (i.e., whether the outcome of pregnancy was known at the time of first contact with the registry) * date the pregnancy exposure is registered * full reporter (i.e., hcp) contact information to allow for follow-up (name, address, etc.) exclusion criteria: pregnant women vaccinated with a different brand of meningococcal b vaccine will not be included. (of note: in the event that it cannot be ascertained to which meningococcal b vaccine the woman was exposed, an unknown exposure cohort will be established and analyzed separately).
nutrients to enhance sleep quality and quantity

Conditions: Sleepiness in Athletes

Summary: identifying non-pharmacological means of enhancing sleep is an important area of research for elite athletes. research completed at the ais has identified that some athletes have difficulties falling and staying asleep during both training and competition. there are a number of dietary components such as nutrients and certain dietary supplements that are purported to decrease sleep latency and increase quality of sleep. while many of these interventions have been investigated in isolation, no research has examined different combinations and/or amounts of these substances to determine the resultant effects on sleep. the results of such a systematic investigation could produce an effective diet based sleep product ("sleep drink'). the optimal components, amounts, and timing of intake of such a sleep drink will be explored. additionally, the effects on sleep will be evaluated using the gold standard of sleep measurement: polysomnography.


Eligibility criteria:
inclusion criteria: * 18-40 year old males exclusion criteria: * exclusion: exclusion criteria will include any observed or disclosed injury, illness, sleep or health issue which may disrupt the subject's performance or endanger their health. participants will need to complete an adult screening tool, as recommended by exercise and sports science australia (essa), to assess this. * blood samples will also be collected to screen for magnesium, zinc and b12 which may influence nutritional impact on sleep. if subjects score above the reference ranges for these measures, they will be excluded. * the pittsburg sleep quality index (psqi) and stanford sleepiness scale (sss) will be used to screen for sleep disturbances. if subjects score outside the reference ranges for these questionnaires, they will be excluded.
initiation of home mechanical ventilation at home in patients with chronic hypercapnic respiratory failure

Conditions: Respiratory Therapy; Respiration, Artificial; Positive-Pressure Respiration; Neuromuscular Diseases; Noninvasive Ventilation; Cost-Benefit Analysis; Ambulatory Monitoring

Summary: objective: to prove that initiation of chronic ventilatory support at home, in patients with chronic hypercapnic respiratory failure due to neuromuscular disease (nmd) or thoracic cage problem is not inferior compared to initiation in a hospital based setting. in addition we believe that the start at home is cheaper compared to an in-hospital start. hypothesis: initiation of chronic ventilatory support at home is effective, safe and cost effective compared to a hospital-based initiation. study design: a nationwide non-inferiority multi-center randomized parallel active control study. study population: patients with chronic respiratory insufficiency due to a neuromuscular disease (nmd) or thoracic cage problem who are referred for chronic ventilator support. intervention: the start of hmv at home standard intervention to be compared to: the start of hmv is normally in a clinical setting as recommended in the national guideline. outcome measures: primary: paco2. secondary: health related quality of life; lung function; nocturnal transcutaneous carbon dioxide assessment and saturation, and costs sample size calculation/data analysis: this is a non-inferiority trial based on paco2 as primary outcome. a difference in favor of the hospital care group of smaller than 0.5 kpa will be labeled as non-inferior. to retain 72 evaluable patients, and allow for drop-outs, we will include 96 patients in total. cost-effectiveness analysis: a cost analysis will be conducted alongside the clinical trial. costs of the initiation of hmv at home and in the hospital will be estimated form a societal perspective over a time horizon of 6 months. time schedule: after an initial phase of 6 months recruitment will start and will take 24 months. thirty-six months after the start of the study the last assessments will be done and analysis and writing of the papers will start. after 42 months the study will end.


Eligibility criteria:
inclusion criteria: * indication to initiate non-invasive ventilatory support in patients with a neuromuscular disease or thoracic cage abnormality who suffer from complaints of alveolar hypoventilation (fatigue, headache of dyspnoea) combined with all following elements: * arterial carbon dioxide \> 6.0 kpa daytime or arterial or transcutaneous carbon dioxide \> 6.0 kpa at night or orthopnea as a result of diaphragm paralysis * age \> 18 years * existence, of a sufficient network (social or professional) according to the supervising hmv center making initiation of hmv at home possible and safe. exclusion criteria: * patients who already have had hmv due to acute respiratory failure * necessity for invasive ventilatory support * patients admitted to a nursing home
recurrence of trigeminal neuralgia in patient's undergoing radiofrequency ablation

Conditions: Trigeminal Neuralgia, Idiopathic

Summary: this study aims to find recurrence rate of the trigeminal neuralgia after patients undergo stereotactic rhizotomy by radiofrequency ablation at 80 degrees celsius for 90 seconds under fluoroscopic guidance, a protocol that was modified from the originally described parameters for rhizotomy by john tew, chad j. morgan and andresw grande et al. the presumption being that the higher temperature of the probe tip would lead to a more long-lasting lesion and lesser recurrence, but at the cost of more frequent sensory and motor deficits.


Eligibility criteria:
inclusion criteria: * 1. patients fulfilling ichd criteria: recurrent paroxysms of unilateral facial pain in the distribution(s) of one or more divisions of the trigeminal nerve, with no radiation beyond, and fulfilling criteria b and c a. pain has all of the following characteristics: 1. lasting from a fraction of a second to 2 minutes 2. severe intensity 3. electric shock-like, shooting, stabbing or sharp in quality b. precipitated by innocuous stimuli within the affected trigeminal distribution c. not better accounted for by another ichd-3 diagnosis. 2. age: adults of both sexes 3. mri brain ruled out organic or structural pathologies exclusion criteria: * 1. patient with concomitant co-morbid conditions like brain tumours, vascular pathologies or coagulopathies. 2. patients who had previously undergone trigeminal ganglion neurolysis with either alcohol or phenol. 3. patients who were lost to follow-up before the completion of 6-month period or had not visited back after the procedure 4. patients on oral anticoagulants 5. patients declared high risk or asa 3 and above for general anaesthesia.

Keywords: trigeminal neuralgia stereotactic rhizotomy radiofrequency ablation recurrence
study to obtain volume effect and safety data on 6 % hydroxyethyl starch 130/0.4 in pediatric and adult patients undergoing major elective surgery

Conditions: Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage

Summary: the study shall evaluate the volume effect and safety of 6 % hydroxyethyl starch 130/0.4 for restoration and maintenance of hemodynamics during the investigational period in patients undergoing major elective surgery. up to 50 ml 6% hydroxyethyl starch/kg body weight will be administered from start of surgery until two hours after end of surgery. the study hypothesis is that 6 % hydroxyethyl starch 130/0.4 will have a reliable volume effect and can be safely administered up to the dose limit.


Eligibility criteria:
inclusion criteria: * patients undergoing major elective surgery * adults patients (≥20 years of age): expected blood loss of ≥ 1000ml pediatric patients (\<20 years of age): expected blood loss ≥ 15 ml/kg * adult patients: routine measurement of central venous pressure (cvp) exclusion criteria: * known or suspected allergy to hydroxyethyl starch, including its ingredients (inclusive corn) and related drugs * asa classification ≥ iv * adult patients: renal failure with oliguria (\<400 ml urin /24hours) and anuria pediatric patients: renal failure with oliguria and anuria not related to hypovolemia * known bleeding disorders * other contra-indications according to the current smpc of voluven 6% solution for infusion.

Keywords: hypovolemia, surgical blood loss
safety and efficacy of bibf 1120 at high dose in idiopathic pulmonary fibrosis patients ii

Conditions: Pulmonary Fibrosis

Summary: idiopathic pulmonary fibrosis (ipf) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate. in a large phase 2 trial (1199.30) (nct00514683), investigating the effects of 52 weeks of treatment with bibf 1120 in patients with ipf, a positive effect was seen on lung function of patients treated with high dose of bibf 1120 compared to placebo. hence it is the purpose of this trial to investigate and confirm the efficacy and safety of bibf 1120 at a high dose in treating patients with ipf, compared with placebo. the trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data. respiratory function is globally accepted for assessment of treatment effects in ipf patients. the chosen endpoint (forced vital capacity (fvc) decline) is easy to obtain and is part of the usual examinations done in ipf patients.


Eligibility criteria:
inclusion criteria: 1. age \>= 40 years; 2. ipf diagnosed, according to most recent american thoracic society (ats), european respiratory society (ers), japanese respiratory society (jrs), latin american thoracic association (alat) ipf guideline for diagnosis and management, within 5 years; 3. combination of high resolution computerized tomography (hrct) pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of ipf 4. dlco (corrected for hb): 30%-79% predicted of normal; 5.fvc\>= 50% predicted of normal exclusion criteria: 1. aspartate aminotransferase (ast), alanine aminotransferase (alt) \> 1.5 x upper limit of normal (uln) 2. bilirubin \> 1.5 x uln; 3. relevant airways obstruction (i.e. pre-bronchodilator fev1/fvc \< 0.7); 4. patient likely to have lung transplantation during study (being on transplantation list is acceptable for participation); 5. myocardial infarction within 6 months; 6. unstable angina within 1 month; 7. bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy; history of hemorrhagic cns event within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or ulcers or major injury or surgery within 3 months); 8. thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months; 9. international normalised ratio (inr) \> 2, prolongation of prothrombin time (pt) and partial thromboplastin time (ptt) by \> 50% of institutional uln); 10. n-acetyl cystein, prednisone \> 15mg/day or equivalent received within 2 weeks of visit 1; 11. pirfenidone, azathioprine, cyclophosphamide, cyclosporine a received within 8 weeks of visit 1;