cyrilzakka/clinical-trials huggingface dataset:
Routine Irrigation With Ropivacaine vs. Lidocaine vs. Saline of Surgical Bed in Sleeve Gastrectomy

The aim of this study is to evaluate the effect of ropivacaine and lidocaine irrigation at the surgical bed on postoperative pain relief and breathing parameters in laparoscopic sleeve gastrectomy.

As in any other surgery, postoperative pain control after bariatric procedure should provide comfort and early mobilisation as well as enable adequate respiratory effort.

Early ambulation is thought to reduce the risk of pressure ulcers, deep vein thrombosis and respiratory complications. In contrast, early inadequate postoperative pain management can lead to hypoxemia, hypercarbia and atelectasis. However, the use of opioids for pain control is limited in bariatric surgery due to sedative effect which might worsen obstructive sleep apnoea (OSA), a common comorbidity amongst morbidly obese patients and opioid-sparing techniques might help avoid respiratory complications.

Methods of regional analgesic are limited and might be challenging in the obese patient and although techniques such continuous epidural analgesia is possible it is not the common practise. The use of patient-controlled i.v. analgesia of opioids is limited owed to increased risk for hypoxemia and other practises such as routine local anaesthetic port site wound infiltration and systemic non-steroidal drugs are warranted.

The benefit of intra-peritoneal irrigation with local anaesthetic for abdominal pain relief after laparoscopic procedures was established in few studies. The aim of this study is to evaluate the effect its' effect on postoperative pain relief and breathing parameters in laparoscopic sleeve gastrectomy.By pain score

Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to sleeve gastrectomy

Exclusion Criteria:

* Second bariatric procedure Patients younger than 18 years Patients who have drug allergy to Lidocaine or Ropivacain Patients who suffer a cardiac arrhythmia Pregnant patients Mentally challenged patients Patients who refuse to participate in the study
Taurine Supplementation and Exercise on Irisin Levels in Obesity

Irisin is a myocin secreted by skeletal muscle in stimulus to physical exercise and has been described as a possible therapeutic tool in the fight against obesity by triggering a cascade of signaling that triggers the expression of genes responsible for the increase in energy expenditure and browning of adipose tissue white cells by activating thermogenesis promoter mitochondrial proteins. Although the science is engaged in the search for evidences about the actions of the irisin, the physical exercise involved and the improvement in the levels of obesity, many mechanisms are still unknown. Since taurine by means of irisin-like pathways also increases energy expenditure, it is believed that taurine supplementation associated with high intensity aerobic physical exercise can optimize the effects of irisin, increasing energy expenditure and improving body composition in obesity.

Introduction: Irisin is a myocin secreted by skeletal muscle when stimulated by physical exercise that promotes increased thermogenesis (browning effect). Similarly, taurine is also associated with modulations of energy metabolism with promising actions in the control of metabolic disorders. Thus, it is believed that chronic taurine supplementation associated with physical training can optimize irisin concentrations after exercise.

Objective: Evaluate the effects of taurine supplementation associated with interval aerobic training on plasma irisin concentrations, energy expenditure, body composition and physical fitness in obese women. Methods: Twenty-two women aged 25 to 45 years, sedentary, with grade I obesity (BMI ≥30-35 kg / m²) and without comorbidities will be recruited for the study. The subjects will be submited to a high intensity interval aerobic training for 8 weeks, being 3 times by week, for 50 minutes, associated to the supplementation with 3g of taurine or placebo.

Methods: Assessment of dietary intake, Resting Energy Expenditure (GER) by indirect calorimetry, body composition by deuterium oxide, anthropometric measurements, HPLC plasma analysis of taurine, multiplex irisin and physical fitness variables will be performed pre and post intervention. The results will be expressed as mean and standard deviation and the ANOVA test two way repeated measures mixed model will be applied, with post hoc Sidak, to verify differences and statistical interactions (p \<0.05).

Eligibility Criteria:
Inclusion Criteria:

* This study included women with obesity grade I (BMI ≥30 - ≤35Kg/m²), sedentary, with no associated comorbidity, convenience sample.

Exclusion Criteria:

* Women classified as overweight, obesity grade II and grade III (morbid), who present comorbidities associated with obesity (pre-diabetes, diabetes, hypertension, dyslipidemia, cardiovascular diseases and diseases of bone metabolism); smokers; who use hormones, sports supplements and / or weight loss medications. Perform some type of nutritional monitoring followed by diet or weight loss guidelines and that have medical impediment to the practice of physical exercise.
Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants

The purpose of this trial is to evaluate the immunogenicity, the safety and the tolerability of rMenB+OMV NZ and MenACWY vaccines in healthy infants, when concomitantly administered at 3, 5, 7 and 13 months of age, compared to either alone.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy 3-month old infants (85-119 days, inclusive) at time of Visit 1 whose parents/legal guardians have given written informed consent after the nature of the study has been explained.
2. Available for all the visits scheduled in the study.
3. In good health as determined by medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria:

1. History of any previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) at the time of enrollment.
2. Previous known or suspected disease caused by N. meningitidis.
3. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization.
4. History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine.
5. Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from, for ex-ample:

   * Chronic administration of immunosuppressants or other immune-modifying drugs since birth (3 months prior). (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day or ≥ 10 mcg/day for children below 2 years. Inhaled and topical steroids are allowed),
   * Immune deficiency disorder, or known HIV infection.
6. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation since birth.
7. History of any progressive or severe neurologic disorder, or seizure disorder or Guillan Barré syndrome (exception: one self-limited febrile seizure is acceptable).
8. History of any bleeding disorder considered as a contraindication to intramuscular injection or blood draw.
9. Child's parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study.
10. Receipt of any investigational or non-registered product since birth (3 month prior) or are expected to receive during the study period.
11. Family members or household members of site research staff.
12. Any clinically-significant chronic or progressive disease according to judgment of the investigator (pulmonary, cardiovascular, renal, hepatic or endocrine functional abnormality) or a congenital anomaly/known cytogenic disorder (e.g., Down's syndrome).
13. History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
Corkscrew Technique: A Novel Modification in Transurethral Resection of Large Prostate (60-100 g) Optimizing Resection Efficacy and Safety: A Double-blind Randomized Controlled Trial

Transurethral resection of the prostate (TURP) is still the gold standard for surgical management of enlarged prostate. However, many techniques and minimally invasive procedures are now in the comparative track with Bipolar resection as Laser enucleation.

Multiple drawbacks of Classic TURP problems related to large prostate management as the retreatment after Bipolar resection, another issue that prolonged operative time, Loss of orientation during resection due to rotation of one of the 2 kissing lobe, Bleeding of the 1st lobe resection side make the 2nd lobe resection harder and lengthier, Median lobe resection or bladder neck resection is done at last to avoid sub-trigonal injury. however, due to median lobe obstruction, irrigation is poor during all the resection. length of learning curve, the modification of early median lobe resection carry the risk of sub-trigonal injury.

So, this study is a trial to analyze the effect of new technique in resection of large prostate with good orientation and less time of operation.


Eligibility Criteria:
Inclusion Criteria:

* BPH causing LUTS with prostate volume between 60 and 100 ml (either by TRUS or CT).
* PSA level below 4 ng/ml.
* IPSS score of 10 and above.

Exclusion Criteria:

* previous history of prostatic biopsy.
* previous history of acute urinary retention.
Long Term Cornea Graft Survival Study

Corneal transplantation have been performed for several decades, follow-up time in some centers now exceeds 30 years. Published long term (10 years and up) graft survivals vary considerably from center to center. These variations may be explained by differences in case-mix and surgical techniques used.

The investigators aim to better understand the factors associated with long term graft survival.


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent one or more keratoplasties since january 1983.
* Age 18 and older
Biomarkers Predicting Infectivity in an Experimental Human Influenza Model

This study aims to test the hypothesis that gene transcriptional changes occur within 24 hours of virus exposure in the blood and nasal mucosa, and to identify early biomarker signatures that are predictive of higher viral shedding at the peak of disease

This study will systematically investigate the early pre-symptomatic period following exposure to influenza in humans. The data obtained will be essential for further understanding of the natural history of human antiviral responses, and will allow us to identify a panel of biomarkers that can predict which individuals will go on to more severe symptoms and higher viral shedding, so that treatments and other interventions can be made at an early stage.

Eligibility Criteria:
Inclusion Criteria:

* Healthy persons aged 18 to 55 years, able to give informed consent

Exclusion Criteria:

* Chronic respiratory disease (asthma, chronic obstructive pulmonary disease, rhinitis, sinusitis) in adulthood
* Inhaled bronchodilator or steroid use within the last 12 months
* Use of any medication or other product (prescription or over-the-counter) for symptoms of rhinitis or nasal congestion within the last 6 months
* Acute upper respiratory infection or sinusitis in the past 6 weeks
* Smoking in the past 6 months OR \>5 pack-year lifetime history
* Subjects with allergic symptoms present at baseline
* Clinically relevant abnormality on chest X-ray
* Those in close domestic contact (i.e. sharing a household with, caring for, or daily face to face contact) with children under 3 years, the elderly (\>65 years), immunosuppressed persons, or those with chronic respiratory disease
* Subjects with known or suspected immune deficiency
* Receipt of systemic glucocorticoids (in a dose ≥ 5 mg prednisone daily or equivalent) within one month, or any other cytotoxic or immunosuppressive drug within 6 months prior to challenge
* Known immunoglobulin A deficiency, immotile cilia syndrome, or Kartagener's syndrome
* History of frequent nose bleeds
* Any significant medical condition or prescribed drug deemed by the study doctor to make the participant unsuitable for the study
* Pregnant or breastfeeding women
* Positive urine drug screen
* Detectable baseline haemagglutination inhibition titres against influenza challenge strains
* History of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine, or with life-threatening reactions to previous influenza vaccinations

All women of childbearing age will have a pregnancy test performed prior to virus inoculation to exclude pregnancy and be required to use contraception throughout the study.
Phage Therapy for the Prevention and Treatment of Pressure Ulcers.

This study will evaluate a topical bacteriophage therapy product (BACTELIDE) as an adjunct to standard therapy for the prevention and treatment of pressure ulcers colonized with S. aureus, P. aeruginosa, or K. pneumoniae species.

This study will compare the safety and efficacy of BACTELIDE in conjunction with standard of care (SOC) versus a placebo in conjunction with standard of care.

The central aim of this study is to investigate the safety, tolerability, and indicative efficacy of a single dose of a phage therapy combination product, BACTELIDE, as an adjunct to standard therapy in participants presenting with a Stage II, III or IV pressure injuries with positive wound cultures for S. aureus, P. aeruginosa, or K. pneumoniae at screening.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Stated willingness to comply with lifestyle considerations
4. Male or female, 18 years or older presenting in long-term care facilities, out-patient department or in-hospital patients with a stage II, III or IV pressure injury with or without local signs of infection with a size not exceeding 28 cm2
5. Within 72 hours before randomization, pressure injury specimen positive for S. aureus, P. aeruginosa, or K. pneumoniae determined by qPCR or rapid diagnostic test or conventional method or positive growth on specific agar.
6. For females of reproductive potential: use of a highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of administration of the study intervention
7. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.

Exclusion Criteria:

1. Diagnosis of Kennedy terminal ulcer, Trombley-Brennan terminal tissue injuries or skin changes at life's end (SCALE).
2. Pregnancy or lactation.
3. Known allergic reactions to components of SilvaSorb hydrogel.
4. Known allergic reactions to components of the phage treatment; including known allergic reactions to bacteriophages, polyester amide urea polymers and/or TMN buffer.
5. Unstable coronary artery disease.
6. Patients diagnosed with Type I or Type II diabetes, uncontrolled (HgbA1c \>8% or 2+ glycosuria).
7. Treatment with another investigational drug or other intervention within 30 days.
8. Intercurrent condition requiring a high dose of chronic corticosteroid therapy, immunosuppressive medication, oncologic chemotherapy.
9. Patients who have additional uncontrolled serious medical or psychiatric illness determined by the investigators where the patient is unfit to receive the product.
10. Chronic stool incontinence without a rectal tube if an individual has a sacral ulcer.
11. Placement of a wound vacuum.
12. Surgical wound closure planned within the study period.
13. Organ failure, acute respiratory failure and chronic renal failure.
14. Diagnosed osteomyelitis.
Bumetanide Versus Furosemide in Heart Failure

Patients with NYHA FC II-III heart failure will be randomized in a cross-over fashion to 8 weeks of bumetanide versus furosemide therapy (equipotent dose), to test whether bumetanide therapy has a superior effect on insulin resistance compared to furosemide. Patients will be subject to a frequently sampled intravenous glucose tolerance test (FSIGT) with minimal model (MINMOD) analysis to assess insulin resistance and to a 6-minute walk test (6MWT) to assess functional capacity; patient recruitment and retention success, as well as medication adherence, will also be assessed.

Insulin resistance is common in patients with heart failure (HF) and is associated with a worse functional capacity and more severe symptoms of heart failure. The majority of HF patients take furosemide on at least a daily basis for symptom relief. Bumetanide is a loop diuretic with a similar therapeutic diuretic effect to furosemide. There is evidence from observational and small comparative trials that bumetanide has a significantly less deleterious effect on indirect measures of insulin resistance compared with furosemide. However, a formal comparison between the 2 drugs using rigorous measures of insulin resistance has never been conducted in patients with HF. If bumetanide can be demonstrated to have a similar diuretic and a superior (less deleterious) effect on insulin resistance in patients with HF, the potential exists for bumetanide to have a significantly reduced morbidity in patients with heart failure compared to furosemide. In order to prepare for such a study, the variance of the MINMOD-derived insulin resistance from the FSIGT (26), in this group of patient needs to be determined along with the feasibility of conducting such a study. Functional capacity will be determined by duplicate 6-minute walk tests.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women ≥18 years of age
2. NHYA FC II or III HF AND documented LVEF ≤40% within 6 months prior to study entry
3. Taking 20 mg to 80 mg furosemide orally once or twice per day
4. No changes to cardiac medications for 3 months prior to study entry and no anticipated changes of medications for the duration of the study
5. No changes to oral anti-diabetic medications (if applicable) for 3 months prior to study entry, and no anticipated changes for the duration of the study (metformin, sulphonylurea type, glitazone type)
6. Ability to provide written consent

Exclusion Criteria:

1. Known sensitivity to bumetanide
2. Myocardial infarction, coronary angioplasty, coronary artery bypass surgery, admission for HF or unstable angina within a 3 month period prior to study recruitment
3. Planned coronary intervention within 6 months
4. Patients who are taking insulin
5. Patients with chronic renal (serum creatinine ≥ 200 μmol/L) or hepatic impairment (known cirrhosis or AST or ALT \> 1.5 x upper limit of normal)
Performance Evaluation of Daily Disposable Contact Lenses in Habitual Lens Wearers Who Use Digital Devices Frequently

The goal of this study is to compare the performance of two daily disposable silicone hydrogel lenses.

This study is prospective, bilateral eye, double masked, randomized, 1 week cross-over, daily wear design involving in two different daily disposable lens types. Each lens type will be worn for approximately one week.

Eligibility Criteria:
Inclusion Criteria:

* Is between 18 and 35 years of age (inclusively) and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Self-reports having a full eye examination in the previous two years;
* Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;
* Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Habitually wears soft contact lenses, for the past 3 months minimum;

  1. No more than 1/3 of participants should be habitual wearer of MyDay or MyDay Energys
  2. No more than 1/3 of participants should be habitual wearer of ACUVUE® OASYS MAX 1-Day or ACUVUE® OASYS 1-Day.
* Has refractive astigmatism no higher than -0.75DC in each eye;
* Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere -1.00 to -6.00D, 0.25D steps).

Exclusion Criteria:

* Is participating in any concurrent clinical or research study;
* Has any known active ocular disease and/or infection that contraindicates contact lens wear;
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
* Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
* Has known sensitivity to the diagnostic sodium fluorescein used in the study;
* Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
* Has undergone refractive error surgery or intraocular surgery.
Persistence of Protective Antibody Titers 12-24 Months After NmVac4-A/C/Y/W-135-DT Vaccination: Follow Up Study

To determine the persistence of protective antibody levels for subjects who seroconverted after vaccination with NmVac4-A/C/Y/W-135-DT™

Participants in trial # JN-NM-002, who seroconverted for serogroups A and C will be contacted and asked to provide a blood sample at 12-24 months after vaccination with NmVac4-A/C/Y/W-135-DT.

Serum Bactericidal Assays will be performed to evaluated duration of protective antibody titer for NmVac4-A/C/Y/W-135-DT for all four serogroups. To determine if subjects who seroconverted with lower titers retain protective levels of antibody (titer ≥:8) at 12-24 months after vaccination.

The purpose of this study is to collect serum samples to evaluate duration of protection for NmVac4-A/C/Y/W-135-DT, based on titers determined by Serum Bactericidal Assay with human complement (hSBA). This assay is used to evaluate immunogenicity of meningococcal vaccines, as a surrogate for efficacy. A titer ≥ 1:8 is considered protective.

Objectives are to evaluate duration of protective antibody titer for NmVac4-A/C/Y/W-135-DT for all four serogroups, and determine if subjects with lower titers, but ≥:8 retain protective levels of antibody at 12-24 months.

Participants in trial # JN-NM-002, who seroconverted for serogroups A and C will be contacted and asked to provide a blood sample at 12-24 months after vaccination with NmVac4-A/C/Y/W-135-DT™.

Serum Bactericidal Assays will be performed to evaluated persistence of protective antibody titer for NmVac4-A/C/Y/W-135-DT for all four serogroups, to determine if subjects who seroconverted with lower titers retain protective levels of antibody (titer ≥:8) at 12-24 months after vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent
* Participant in trial JN-NM-002
* Seroconverted in trial JN-NM-002 for both serogroups A and C

Exclusion Criteria:

* Chronic medication use or medical history that, in the opinion of the Investigator, may impact the quality of the sample or safety of the subject