cyrilzakka/clinical-trials huggingface dataset:
Incidence and Factors Associated With PONV in Regional Anaesthesia

Post-operative nausea and vomiting (PONV) is one of the complications associated with surgery and anaesthesia. The main aim of the study is to determine the incidence of post-operative nausea and vomiting among surgical patients undergoing regional anaesthesia and the factors associated with it. Patients above the age of 18 who have consented and are undergoing surgery under regional anaesthesia will be enrolled into the study over 6months. They will then be observed for up to 24 hours post operatively to determine the incidence of PONV and factors associated with it.

Post-operative nausea and vomiting (PONV) is one of the complications associated with surgery and anaesthesia. Due to advanced techniques in the field of anaesthesia and surgery, patients are commonly operated on under regional anaesthesia (RA) rather than general anaesthesia (GA). Post-operative nausea and vomiting (PONV) still occurs with regional anaesthesia, but the incidence and associated factors in our setting remain unknown. An optimal management of PONV is important because they can lead to increased morbidity.

The main aim of the study is to determine the incidence of post-operative nausea and vomiting among surgical patients undergoing regional anaesthesia and the factors associated with it.

This will be a prospective cohort study. Patients aged 18 years and above in whom surgery under regional anaesthesia is planned at Mulago hospital will be consented and enrolled into the study over 6months. Data will be collected using semi structured and pre-tested questionnaires. Patients will be observed for up to 24 hours post operatively to determine the incidence of and factors associated with PONV in regional anaesthesia at Mulago hospital. After recruitment, patients will be followed up once at 24 hours post-operatively.

Results from this study will determine the incidence of post-operative nausea and vomiting in surgical patients undergoing regional anaesthesia and the associated factors, data which we do not have in our setting. This will help to guide practice on the prevention and management of post-operative nausea and vomiting.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing regional anaesthesia for emergency or elective surgery.
* Patients aged 18 years and above.
* ASA class 1, 2, 3 and 4 patients

Exclusion Criteria:

* Patients who are switched to general anaesthesia after planned regional anaesthesia.
* Patients with pre-existing nausea and vomiting from co-morbidities.
Influence of Bionecteurs on Catheter-associated Infection

Bionecteur® is a protective non-touch applicator to ensure aseptic connection made by Vygon. However, there are no studies describing a positive effect of using Bionecteurs ® in regard to catheter-related bloodstream infections. In this study Bionecteur® will be used on central venous lines and arterial lines in postoperative patients of a 40-bed ICU. The incidence of catheter-related bloodstream infections will we compared to patients without inclusion of Bionecteur® devices.

* Prospective, randomised observational study
* Postsurgical patients in an anesthesiological ICU with ICU LOS (LOS: length of stay) \> 3 days

  * Inclusion:

    ---- Age ≥ 18 years

    ---. demand of central venous and arterial line

    --- written consent of patient and/or assignee
  * Exclusion

    * Handicapped patients
    * patient with ICU LOS \< 3 days
* Study design

  1. Three days after admission to ICU blood cultures are drawn to exclude preexisting blood stream infection
  2. Patients in a bed with even number are assigned to Bionecteur® group. Control group (without using bionecteurs) are patients with an odd bed number.
  3. Biconecteurs® are connected to all lumens of the central catheter and to arterial catheter. Control group is treated without using Bionecteurs®. Handling of vascular catheters are performed as described in institutional guidelines in both groups.
  4. Catheter-related bloodstream infections are monitored by an independent person during ICU treatment
  5. The study will be finished ab discharge of ICU or removal of catheters.

Eligibility Criteria:
Inclusion Criteria:

* Length of Stay (LOS) in ICU \> 3 days
* written consent by patient or notarial carers
* medical indication for central venous line/arterial line

Exclusion Criteria:

* handicap
* LOS ICU \< 3 days
* no consent
Identification of New Candidate Genes for Hereditary Predisposition to Uveal Melanoma

Only 20% of familial uveal melanomas are explained by a hereditary predisposition, implying the presence of as yet unknown hereditary predispositions. This hypothesis is reinforced by epidemiological studies revealing an excess risk of prostate cancer, thyroid cancer and leukemia in patients who have developed uveal melanoma, even though these cancers are not part of the tumor spectrum of known hereditary predispositions to uveal melanoma (BAP1, MBD4). The identification of new candidate genes, once validated, would enable us to offer these families appropriate surveillance.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a personal history of uveal melanoma (newly diagnosed, under treatment or in follow-up)
* Enrolled in or benefiting from a social security scheme

Exclusion Criteria:

* Causal pathogenic variation identified in BAP1 or MBD4
* Patient does not consent to constitutional genetic analysis for diagnostic purposes
* Patient not consenting to a constitutional genetic analysis for research purposes
* Pregnant and breast-feeding women
* Patients under guardianship or trusteeship
Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)

To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4 weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a calibrator.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women \> age 18 or legal age of majority with elevated LDL-C
2. Patients not having adequate control of their hypercholesterolemia based on their individual level of CVD risk
3. Willing and able to comply with clinic visits and study-related procedures
4. Provided signed informed consent

Exclusion Criteria:

1. Recent (within 3 months prior to the screening visit) myocardial infarction, unstable angina leading to hospitalization, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease
2. Known history of positive test for human immunodeficiency virus (HIV)
3. Any clinically significant abnormality identified at the time of screening that in the judgment of the investigator or any sub-investigator would preclude safe completion of the study or constrain assessment of endpoints, such as major systemic diseases or participants with short life expectancy.
4. Participants considered by the investigator or any sub-investigator to be inappropriate for this study (e.g, geographic or social), actual or anticipated, that the investigator felt would restrict or limit the participant's participation for the duration of the study.
5. Certain laboratory findings obtained during the screening period

The information listed above is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.
Efficacy and Safety of Combivent® Aerosol and Spacer, in Adult Patients With Moderate to Severe Asthma Crisis

Study to evaluate the bronchodilator efficacy and safety of a fixed combination of salbutamol sulfate (120 mcg) + ipratropium bromide (20mcg) (Combivent® MDI) in aerosol plus spacer in adult patients with moderate-to-severe asthma crisis who arrived at the emergency room.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with a diagnosis of asthma according to the American Thoracic Society (ATS) presenting at the emergency room with an acute moderate and/or severe asthma attack
* Patients aged between18 to 40 years
* Patients able to perform spirometry (PEFR and FEV1)
* PEFR \< 60% and \> 25 % of predicted normal value or a FEV1 \<= 60% of predicted normal value
* Patients able to sign witnessed informed consent

Exclusion Criteria:

* Patients with very severe or life threatening obstruction, manifested by:

  * Cyanosis of tongue and lips
  * Confusion, drowsiness, coma or exhaustion
  * Silent chest on auscultation or weak respiratory effort
  * PEFR \< 25% the predicted normal value
  * Bradycardia (of less 60 beats/min)
* Patients with a smoking history of more than 10 pack/years
* Patients with chronic obstructive pulmonary disease (COPD)
* Patients on treatment for or suspected as having glaucoma
* Patients with uncontrolled hypertension
* Patients with known allergy or contra-indications to either salbutamol, ipratropium or hydrocortisone or their excipients
* Female patients known or suspected to be pregnant or nursing
* Patients known or suspected on clinical grounds to have pneumonia, pneumothorax or pneumomediastinum
* Patients with a history of chest surgery
* Patients with other respiratory conditions if diagnosed. These included pulmonary fibrosis, bronchiectasis, cystic fibrosis, pulmonary tuberculosis, pulmonary complications of AIDS, lung cancer
* Patients requiring drugs for the treatment of the acute asthma attack other than the study drug, hydrocortisone or oxygen
* Patients who have previously recruited into this study
* Patients who have been on other investigational drugs within three months prior to study entry
* Patients with acute myocardial infarction, pulmonary edema or other life threatening disease, which in the judgment of the ER (Emergency room) physician precluded entry into the study
* Patients with obvious or previous diagnosed serious hepatic or renal impairment or bladder neck obstruction
Young Hearts, Strong Starts

This is a cluster randomized trial of pediatric cardiovascular risk reduction guideline implementation in 32 clinical practices

Objective: The Young Hearts Strong Starts Study was designed to test strategies to facilitate adoption of the Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents among pediatric and family medicine providers. The study compares quality measures based on the guidelines for two dissemination strategies: a multi-faceted, practice-directed intervention or standard dissemination.

Methods: Two primary care research networks recruited practices and provided support for the intervention and outcome evaluations. Individual practices were randomly assigned to either the intervention or control groups using a cluster randomized design based on network affiliation, number of clinicians per practice, urban vs. nonurban location, and practice type. In this design, the units of observation are individual children because outcomes are abstracted from medical records for individual patients. The units of randomization are physician practices. This results in a multilevel design in which patients are nested within practices. Implementation The intervention practices receive toolkits, including guideline summaries and slides, a patient and family behavior change workbook, and a clinical decision support tool. Guideline implementation was promoted through an introductory academic detailing session and the use of an ongoing e-learning group. The intervention strategy was further enhanced by aligning this project with the American Board of Pediatrics quality improvement Maintenance of Certification (MOC) requirements and offers voluntary MOC participation to participants. MOC participation includes the creation of a practice aims statement, monthly physician self-abstraction to track progress throughout the intervention, and participation in webinar presentations and sharing of best practices.

Eligibility Criteria:
Inclusion Criteria:

* Patients seen for well child visits

Exclusion Criteria:

* Terminally ill patients
A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease

This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one dose of the tested drug is more effective than placebo (inactive drug).


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between the ages of 18 and 75 years at screening (upper age limit will be 64 years in India and 65 years in the Netherlands).
* Subjects with clinical diagnosis of Crohn's disease for at least 6 months prior to screening.
* Subjects with active moderate to severe ileal, ileocolic, or colonic CD defined by a baseline score of Crohn's Disease Activity Index (CDAI) of 220 to 450 at baseline.

Exclusion Criteria:

* Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings suggestive of UC.
* Subjects diagnosed with Crohn's disease but without previous exposure to treatment (i.e., treatment-naïve).
* Subjects receiving the following treatment for Crohn's disease:
* Azathioprine, 6-mercaptopurine or methotrexate within 2 weeks prior to baseline.
* Anti-TNFα therapy within 8 weeks prior to baseline.
* Interferon therapy within 8 weeks prior to baseline.
* Cyclosporine, mycophenolate, or tacrolimus within 4 weeks prior to baseline.
* Intravenous corticosteroids within 2 weeks prior to baseline.
Comparative Study of Two Corneal Graft Storage Media: New Animal Compound Free Medium Versus Reference Medium

At present, all commercially available corneal organ culture media contain foetal calf serum (FCS) and sometimes other compounds extracted from animals. These compounds are necessary for corneal cell survival but are problematic because they theoretically have risk of anthropozoonosis transmission, especially for new variant of CJD and the variability between FCS batches influence graft quality. Our laboratory research allowed in vitro and ex vivo validation of a new medium free compound animal. We proved its superiority over conventional medium containing 2% FCS for endothelial cell survival during the storage time. The goal of this clinical trial is now to assess its superiority in patients.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients
* over 18 years of age
* Clinically proven corneal disease
* Registered on the French National waiting list (GLAC)
* Patient informed consent
* Patient who needs a 8.25mm of diameter perforating keratoplasty, either isolated or combined with lens surgery
* Low immune rejection risk (\< 2 quadrants of neovascularization, no previous history of herpetic keratitis nor graft rejection)
* No previous history of glaucoma or elevated intra ocular pressure (\>22 mm

Exclusion Criteria:

* Patient is unlikely to comply with the requirements of the protocol
Thoracic Fluid Content During Hypervolemic Hemodilution

Thoracic fluid content (TFC) is one of the many variables measured by the ICON electrical cardiometry (EC) device (Osypka Medical). The ICON device is often called "thoracic electrical bio-impedance" that based on measuring the changes in total resistance of the thorax to electric current and is considered a numerical measure of total (intravascular and extravascular) thoracic fluid. Although TFC is a measure of both extra and intra-vascular thoracic fluid, it provides an estimate of the increase in intrathoracic fluids such as to facilitate the risk of pulmonary edema.

Although many studies were done on the ability of TFC to detect pulmonary edema in preeclampsia, ARDS, heart failure, weaning from mechanical ventilation and during fluid management in prolonged surgery , yet, there is no study before was done on the use of TFC as a guide for fluid therapy during hypervolemic hemodilution in major obstetric surgery in patients with placenta accreta as one of the most common etiologies of life-threatening obstetric hemorrhage and the most common cause of peripartum hysterectomy

Aim of the work:

To use TFC as a guide for 6% HES infusion of hypervolemic hemodilution in patients with placenta accreta to avoid fluid overload.

Objectives:

* To calculate LUS score at the end of infusion.
* To evaluate TFC in k ohm-1.
* To assess oxygen saturation, PO2 and P/F ratio in ABG.
* To calculate the total infused volume in milliliters.


Eligibility Criteria:
Inclusion Criteria:

* female
* 18-45 years old
* ASA I-II

Exclusion Criteria:

* younger than 18 years,
* ASA \> or = III
* patients with respiratory, cardiac disease, cardiac arrhythmias,
* body mass index above 40 kg/m2
* renal insufficiency,
* sepsis,
* hypovolemia denoted by PPV \> 13 detected after start of mechanical ventilation,
* preoperative baseline LUS score 10 or more,
* TFC \> or = 26 k ohm-1,
* patients with neck or chest lesions that impair the application of cardiometry electrodes
Priority Setting and Waiting Time Decision in the Referral Process, How and by Whom?

The referral letter is used for different purposes: a request for a special diagnostic assessment or medical treatment that the GP cannot perform for the patient, an invitation to have a second opinion about a clinical problem or a wish for mutual responsibility for the medical handling. The individual referral rate between GPs varies greatly, and is an important determinant of secondary care utilization. We wanted to study the various elements and factors having an impact on the referral process, from the moment the GP decides to refer the patient until the hospital consultant assess the referral and prioritise the patient for further investigation or treatment. How and why are we, the GPs who refer, so different? We wanted to

1. identify and describe general practitioners' reflections on and attitudes to the referral process and cooperation with hospital specialists
2. identify and describe hospital consultants' reflections on and attitudes to the referral process and cooperation with general practitioners
3. identify typologies characterising GPs in the referral practice

Design and Methods:

We did two qualitative and one quantitative study. The first was a focus group study with GPs in CPD groups, the second an individual study with hospital consultants, both analyses by using systematic text condensation. The third was a quantitative registration of impressions, facts and feelings in the referral process using a principal component analysis to find typologies for GPs who refer to hospital.

Participants:

GPs referring to Stavanger University Hospital. Hospital consultants at Stavanger University Hospital.

Intervention: No intervention was performed.

Time schedule:

Data Collection finished May 2014.

Eligibility Criteria:
Inclusion Criteria:

All the 300 GPs referring to Stavanger University Hospital who participate in one of the 58 CPD groups in South Rogaland County and who agree to participate in the study are included.

Exclusion Criteria:

GPs not willing to participate
Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients

This study is a prospective, multicenter study in which a serum sample will be collected at the day of starting neo adjuvant treatment in breast cancer patients


Eligibility Criteria:
Inclusion Criteria:

* Women with a new diagnosis of triple negative breast cancer who have not yet started systemic treatment.
* Patients with stage I-III disease, patient with locoregional recurrence who have not been treated with chemotherapy before. ,
* Aged \< 60 years
* Women having a (regular) physiological menstrual cycle
* Patients who are assigned to receive neoadjuvant chemotherapy with or without immunotherapy, targeted therapy and endocrine therapy
* Patients must be systemic treatment naïve for current malignancy (e.g. no chemotherapy, hormonal therapy or targeted therapy)
* Signed written informed consent

Exclusion Criteria:

* current use of hormonal contraception or in the six weeks prior to start of neoadjuvant systemic treatment for breast cancer, such as:
* Oral contraception (OAC)
* Hormonal intra-uterine device (IUD, Mirena)
* No ovarian function suppression to preserve fertility
* Other forms of hormonal contraception, including but not limited to: nuva-ring, Implanon, prikpil
* Currently pregnant and / or breast feeding. In case of use of hormonal contraception or breast feeding in de last year: patients should have had at least 2 menstrual cycles since stopping hormonal contraception.

  - active other malignancy
* IVF-trajectory for egg cell preservation prior to start of neoadjuvant systemic treatment
Taste Test Between Desloratadine and Cetirizine Syrup in Children (Study P03829)(COMPLETED)

This study was conducted to compare the taste acceptability of Zyrtec syrup with desloratadine syrup in children. Children between 6 and 11 years of age received 5 mL of each syrup, separated by 15 to 20 minutes on a single day.

This study is a cross-over study design.

Eligibility Criteria:
Inclusion Criteria:

Subjects must be:

* Between 6 and 11 years of age in good general health
* Premenarcheal if female

Exclusion Criteria:

Subjects who:

* Have known allergies or sensitivities to either of the drug formulations
* Have a medical condition that may interfere with the subject's ability to discriminate between tastes
* Have used any antihistamines within 24 hours prior to dosing
* Were taking sedatives, tranquilizers, or monoamine oxidase inhibitor drugs
* Were involved in another clinical or market research study within the past 30 days
Transfer to Another Health Care Facility Following Critical Illness

The purpose of this study is to identify acute and chronic medical conditions that are identifiable early in the course of critical illness that are associated with transfer to another health care facility (versus to home) upon hospital discharge.

Many patients who survive critical illness are unable to return home upon hospital discharge and require prolonged or permanent care in other health care facilities. It would be useful to clinicians, researchers, patients, and patients' families to be able to identify early in the course of critical illness those patients who are at increased risk for this outcome. Currently, few data exist regarding the risk factors for this outcome. This study examines a cohort of survivors of critical illness to identify factors associated with transfer to another health care facility upon hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Admission to the University of Chicago Medical Intensive Care Unit during the following periods: July 1997 to February 1998, November/December 2001, and March/April 2002.

Exclusion Criteria:

* Death during the index hospitalization.
* Residence in another health care facility 2 weeks prior to admission.