cyrilzakka/clinical-trials huggingface dataset:
Preoperative Oral Magnesium to Prevent Postoperative Atrial Fibrillation Following Coronary Surgery (POMAF-CS)

Post operative atrial fibrillation following coronary surgery (POAF) is a common complication that can affect 10-50% of patients.

Intravenous magnesium, administered per-or post-operatively, reduces the incidence of POAF. However, the effect of preoperative magnesium loading on the incidence of POAF is not yet studied.

200 patients admitted for elective coronary surgery under Cardiopulmonary bypass will be included in this prospective randomized controlled trial.

Treatment group will receive preoperative oral magnesium and control group will receive placebo for 3 days before the planned coronary artery surgery.

The occurrence of POAF will be studied as a main outcome.

Post operative atrial fibrillation following coronary surgery (POAF) is a common complication that can affect 10-50% of patients. It is associated with many complications. POAF increases the postoperative length of stay and increases the cost of hospitalization.

Several studies and meta-analyzes have demonstrated the beneficial effect of intravenous magnesium (Mg), administered per-or post-operatively, in reducing the incidence of POAF. However, the effect of preoperative magnesium loading on the incidence of POAF is not yet studied.

The aim of this study is to study the effect of oral Mg, administered preoperatively, on the incidence of POAF.

Following IRB approval, 200 patients admitted for elective coronary surgery under Cardiopulmonary bypass will be included in this prospective randomized controlled trial. Patients will be allocated inn a 1: 1 ratio in 2 groups:

* Treatment group will receive preoperatively 8 tablets of Mg (3.2 g) per day, at day (-3), day (-2), and day (-1) before the day of planned coronary artery surgery.
* Control group will receive 8 tablets of placebo daily,at day (-3), day (-2), and day (-1) before the day of planned coronary artery surgery.

The anesthetic and surgical management protocols will be identical for both groups. The occurrence of POAF during the 7 postoperative days, the main outcome of the study, will be recorded, including the number of POAF episodes, their duration, recurrence, and the associated ventricular response rate. From a safety point, the occurrence of complications and the length of hospital stay will be noted.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Coronary artery disease
* Planned coronary artery surgery
* signed informed consent

Exclusion Criteria:

* Preoperative supraventricular dysrhythmia including atrial fibrillation, either acute or chronic
* Left ventricular EF \< 30%
* Urgent surgery
* Redo surgery
* Permanent preoperative pacemaker
* Preoperative anti arrythmia drugs classes I and III
* Post operative inotrope drugs
* Postoperative bradycardia necessitating electrosystolic pacing
* Preoperative heart rate less than 50 bpm
* documented preoperative dysthryroidism
* 2nd and 3rd degree atrioventricular bloc
* Renal failure with GFR \< 30 ml/min/1.73 m²
Bioequivalence of the New Formulation of WAL 801 CL Dry Syrup Compared to the Conventional Formulation of WAL 801 CL Dry Syrup in Healthy Male Volunteers

To establish the bioequivalence of the new formulation of WAL 801 CL dry syrup vs. the conventional formulation of WAL 801 CL dry syrup


Eligibility Criteria:
Inclusion Criteria:

* Healthy males according to the following criteria:

  * Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature (BT)), 12-lead ECG, clinical laboratory tests (including gastric acidity (GA) test)
  * No finding of clinical relevance
  * No evidence of a clinically relevant concomitant disease
* Age ≥ 20 and Age ≤ 35 years
* BMI ≥ 18.5 and BMI ≤ 25 kg/m2 (Body Mass Index)
* Signed and dated written informed consent prior to Screening Phase and prior to Treatment Phase (Day -1 in Treatment period 1) in accordance with Japanese Good Clinical Practice (GCP)

Exclusion Criteria:

* Current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* History of surgery of gastrointestinal tract with the exception of appendectomy
* History of (and/or current) diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Current chronic or relevant acute infections
* History of hypersensitivity (including drug allergy) or current allergic disorders which are deemed relevant to the trial by the investigator or the sub-investigators; e.g. bronchial asthma, allergic rhinitis, atopic dermatitis and food allergy (excluding asymptomatic seasonal rhinitis/hay fever)
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to drug administration and during Treatment Phase
* Use of any drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation, within 10 days prior to administration and during Treatment Phase
* Participation in Phase I trial of new chemical entities within 4 months prior to drug administration and during the trial, or in another clinical trial within 3 months prior to drug administration and during Treatment Phase
* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
* Inability to refrain from smoking during hospitalization
* Alcohol abuse (more than 60 g/day) (confirmed by interview)
* Drug abuse (confirmed by interview)
* Whole blood donation (400 mL within 3 months or more than 100 mL within 4 weeks prior to drug administration or during the trial) or component blood donation (within 2 weeks prior to drug administration or during Treatment Phase)
* Excessive physical activities (within 48 hours prior to each treatment period and during hospitalisation)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of study centre
Wear and Migration in the Corin Mini-Hip/Metafix and ECIMA Polyethylene

The primary objective of this study is to determine whether the Mini Hip (Corin, U.K.) femoral component has a predictable and stable migration pattern (mean migration of the femoral component in three-dimensions,in mm) over a three year period, compared to a conventional cementless stem (Metafix, Corin, U.K.). The secondary objectives of this study are to determine whether the Trinity (Corin, U.K.) acetabular component has a predictable and stable migration pattern over a three year period and to measure the linear wear of femoral head into the ECIMA Highly Cross-linked polyethylene.


Eligibility Criteria:
Inclusion Criteria:

* Women and men between the ages of 18 and 65 years old.
* Scheduled to receive a hip replacement
* Willing and able to give informed consent for participation in the study.
* Diagnosed with hip osteoarthritis
* Able (in the investigators opinion) and willing to comply with all study requirements.
* Willing to allow his/her General Practitioner and consultant, if appropriate, to be notified of participation in the study

Exclusion Criteria:

The participants may not enter the study if ANY of the following apply:

* Inflammatory arthropathy, osteoporosis or deformities of the proximal femur.
* Significant comorbidities that would make follow up difficult or uncomfortable
* Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk due to participation in the study, may influence the result of the study, or the participants ability to participate in the study.
A Trial of Heparin in Patients With Severe Sepsis Who Are Undergoing Treatment With Drotrecogin Alfa (Activated)

The purpose of this study is to evaluate the relative efficacy and safety of prophylactic heparin co-administration during drotrecogin alfa (activated) infusion in the treatment of severe sepsis in the adult.


Eligibility Criteria:
Inclusion Criteria

* Adults greater than or equal to 18 years of age
* Receiving inpatient treatment for severe sepsis
* Indicated for treatment with Drotrecogin Alfa (Activated) under approved label in the country where the patient is enrolled

Exclusion Criteria

* Contraindicated for heparin treatment
* Require a higher dose of heparin than defined in the trial
* Have acute or chronic renal failure with an estimated creatinine clearance less than 30mL/min
* Weigh more than 135 kg (297 pounds)
* Are not expected to survive 28 days given their medical condition.
Efficacy of Omega-3/Omega-6 Fatty Acids in Pre-school Children at Risk for ADHD

The efficacy of PUFAs (as nutritional supplement) in/for pre-school children with ADHS symptoms will be evaluated in a randomised controlled doubleblind trail with children aged 3-6 years.

The study aims at the reduction of hyperactivity, inattention and impulsivity in pre-school children aged 3-6 years, visiting a preschool, and the prevention of clinical ADHD symptoms. The 3-6 years old children will be identified by a combined parent and teacher rating ADHD-symptoms questionnaire (FBB-ADHS-V). Children with ADHD symptoms \>90th percentile will participate in a following diagnostic process. The children (n = 150) will be randomised doubleblind to a control group (taking every day four capsules Equazen eye q, containing 400 mg fish oil and 100mg evening primrose oil - EPA (372mg), DHA (116mg), GLA (40mg) and vitamin E (7.2 mg) ) or placebo group. The study is divided into two phases with four months each. After unblinding after the first phase pre-school children taking placebo receive Omega-3/Omega-6 Fatty Acids. Children (n = 75) taking verum during first four months will be randomised doubleblind to verum or placebo. In this way the progress of the behaviour symptoms will be evaluated after a significant period of time (eigth months). Clinical examination (questionnaires, intelligence test, medical examination) and evaluation of ADHD symptoms through parents and teachers with several questionnaires will be used before beginning, after four months and after eight months. In addition the pre-school children will be taken a blood sample (finger prick test) to measure the omega-3/omega-6 fatty acids levels. Additionally regular phone calls will be implemented. Medical examinations and meetings will taken place if required. If symptoms increase, children will be treated medical and/ or psychotherapeutically.

Eligibility Criteria:
Inclusion Criteria:

* Age: 3 - 6 years
* Visit of a preschool (Kindergarten)
* Parents have a command of the German language
* Screening score \>90th percentile in a combined parent and teacher screening questionnaire

Exclusion Criteria:

* Hypersensitivity or inability to components of the study product (fish oil, primrose oil, natural strawberry flavouring, bovine gelatine)
* Consumption of omega fatty acids preparation
* Consumption of fish oil-capsules
A Study Comparing Doxycycline and Levofloxacin for Treating COPD Exacerbations

This study will include patients with chronic obstructive pulmonary disease (COPD) who present with an acute exacerbation. Participants will be randomly assigned to receive either doxycycline or levofloxacin for 5 days. The aim is to compare how effective each antibiotic is in improving symptoms after 2 days of treatment.

This randomized controlled trial will evaluate the effectiveness of two antibiotics-doxycycline (a tetracycline) and levofloxacin (a fluoroquinolone)-in the treatment of acute exacerbations of chronic obstructive pulmonary disease. Participants will be assigned to one of the two treatment groups and will receive either doxycycline 100 mg twice daily or levofloxacin 500 mg once daily for 5 days. The primary outcome is clinical cure. This will be evaluated 2 days after completion of antibiotic therapy, based on symptom resolution and laboratory markers.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed cases of COPD Exacerbation of COPD Able to provide Written consent No anti biotic taken with in past 4 weeks

Exclusion Criteria:

* hypersensitivity to any drugs Pneumonia evidence on xray/ hrct chest Any other pulmonary condition e.g asthma Pregnancy/breast feeding Taking treatment for other active infections
Effects Of High Voltage Pulsed Current On Post-Traumatic Injuries

The investigators hypothesis is that HVPC with negative polarity diminishes local post-traumatic edema in ankle sprains. Therefore, the objective of this study was to analyze the effect of HVPC on edema secondary to ankle sprains in humans.

Most studies have investigated the effects of HVPC on edema in animals and only one in humans was identified. The studies had showed that HVPC had some advantages for controlling edema in animals but there are not yet conclusive results on the effect of this intervention in humans.For this reason, we proposed a randomized controlled double-blinded clinical trial with three groups of intervention. In our study compared the effects of standard physical therapy treatment with the HVPC with negative and positive polarity.

Eligibility Criteria:
Inclusion Criteria:

* Ankle post traumatic edema secondary to a sprain
* Sprain with evolution between 2 and 96 hours
* Sprain positive to anterior drawer test or lateral inclination mobilizations.

Exclusion Criteria:

* Subjects with grade III sprains that required surgical management
* Edema secondary to systemic illness
* Muscular dystrophy or atrophy
* Injuries, open or infected zones
* People taking anti-inflammatory medication or using empirical treatment as tractions, strong massages or manual.
Pain and Anxiety Control During Traditional Mandibular Anesthesia in Children Using Distracting Tools

The aim of this study is to evaluate the effectiveness of two different audiovisual distraction techniques (Audio Video eyeglasses "VR BOX"/ Tablet) in the management of anxious pediatric patients during inferior alveolar nerve block

Group A (Control group): IAN will be administrated with basic behavior guidance techniques and without using any type of distraction aids.

Group B: IAN will be administrated with using AV eyeglasses "VR BOX" and wireless headphone.

Group C: IAN will be administrated with using tablet device and wireless headphone

All of the children who experienced an inferior alveolar block with/without distraction will be assessed by using a combination of measures: Wong-Baker FACES (self-report), pulse rate (physiological) and behavior (using FLACC behavior rating scale "external evaluator

This study will evaluate the effectiveness of two types of distraction aids that contain video using (tablet device or VR BOX eyeglasses) and audio distraction using wireless headphone. pain and anxiety will be evaluated during inferior alveolar nerve block using three behavioral scales, Wong-Baker FACES (self-report), pulse rate (physiological) and behavior (using FLACC behavior rating scale "external evaluator".

The first measure of heart pulse rate will be recorded directly when the patient seated comfortably on the dental chair, after anesthesia, the second heart pulse rate will be taken and the child patients will ask to choose a face that describe their status from one of the Wong Baker faces scale.

For each child patient, all of the body responses will be recorded during the whole procedure and then will be evaluated by an external assessor to determine the children behavioral score according to FLACC scale.

Eligibility Criteria:
Inclusion Criteria:

1. age between 6 and 10 years.
2. no previous dental experience.
3. definitely positive or positive ratings of Frank scale.
4. Need of IAN block for any dental treatment.

Exclusion Criteria:

1. previous dental experience
2. systematic or mental disorders.
3. definitely negative or negative ratings of Frankel scale
4. Any contraindication for regional anesthesia
Optiflow THRIVE for Delivery of Oxygen to Patients During Total Intravenous Anesthesia While Undergoing Radiology Procedures

This trial studies how well Optiflow THRIVE works in delivering oxygen to patients during total intravenous anesthesia while undergoing radiology procedures. The Optiflow THRIVE is an oxygen administration device that delivers high-flow and humidified oxygen through the nose. The Optiflow THRIVE device may improve oxygen delivery and reduce breathing complications.

PRIMARY OBJECTIVE:

I. To investigate the performance of Optiflow THRIVE relative to Standard Non-Rebreathers in patients with high risk of difficult airway management undergoing interventional radiology procedures for the planning of future clinical studies.

SECONDARY OBJECTIVE:

I. To describe the episodes of hypoxia (defined by peripheral capillary oxygen saturation \[SpO2\] less than or equal to 92%) and the episodes of airway support which include: jaw thrust, chin lift or insertion of an airway supporting device, such as oral/nasal airway or supra airway device in order to recover the level of oxygenation above 92% associated with Optiflow THRIVE.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive 100% oxygen at a high flow rate via Optiflow THRIVE over 3 minutes prior to anesthetic induction and at a higher flow rate until the end of procedure.

ARM II: Patients receive 100% oxygen at a lower flow rate via non-rebreather mask over 3 minutes prior to anesthetic induction and maintain the same flow rate until the end of procedure.

After completion of study, patients are followed up at 15 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Signed consent for the study
* Patients with an SpO2 greater than or equal to 95% while breathing room air
* Patients requiring total intravenous anesthesia (TIVA) but not tracheal intubation during the proposed procedure - PLUS, any of the 2 following criteria: Body mass index (BMI) greater than or equal to 32 kg/m\^2, or neck circumference greater than or equal to 43 cm in a male and 41 cm in a female, or has been diagnosed with moderate to severe obstructive sleep apnea (OSA) with/without using a continuous positive airway pressure (CPAP) device
* Full course head and neck radiotherapy less than or equal to 6 months (the peak onset time of acute facial and airway edema)

Exclusion Criteria:

* Significant pulmonary disease requiring supplemental oxygen in daily life (severe pulmonary fibrosis, severe chronic obstructive pulmonary disease, etc.)
* Significant cardiac disease (including history of myocardial infarction \[MI\] with concurrent evidence of ischemic myocardial damage at the event, cardiomyopathy with impaired left ventricular ejection fraction to less than 50% or uncompensated congestive heart failure)
* TIVA is contraindicate or having a proposed procedure without TIVA
* Endotracheal intubation is required
* American Society of Anesthesiologists (ASA) physical status classification 5
* Patients who are non-English speaking
* Emergency procedures
Effects of Adherence Therapy on Medication Adherence in Patients With Schizophrenia Spectrum Disorder

This study will explore the effect of Adherence Therapy(AT) on medication adherence in patients with schizophrenia spectrum disorder.

A single-blind, randomized controlled trial with a repeated-measures, two parallel groups design will be conducted for 120 participants with schizophrenia spectrum in regional hospital in northern Taiwan. After baseline data collection finished, the blocked randomization will be employed to assign participants to two groups. The experimental group will participate in a eight session course of Adherence Therapy. The control group received routine care. The data will be collected for baseline(T0) and after 4 session interim analysis(T1；9-12 weeks) and 8 session after intervention(T2；21-28 weeks). A structured Questionnaire will use to collect data on the Medication Adherence Rating Scale, Schedule for the Assessment of Insight, Internalized Stigma of Mental Illness Scale, Self-Appraisal of Illness Questionnaire and Positive and Negative Syndrome Scale. Data analysis will employ Statistical Package for the Social Sciences 20.0 with Generalized estimating equations approach to examine effects of Adherence Therapy and routine care on medication adherence.

Eligibility Criteria:
Inclusion Criteria:

* aged 20-64
* were Chinese speaking or Taiwanese speaking;
* diagnosed with schizophrenia or schizoaffective disorder
* recent history of non-adherence to antipsychotic medication.

  1. Non-adherence to medication was defined as a recent history of cessation of psychiatric admission for more than one month at a time
  2. The patient recently (half year) relapse of mental illness
  3. Family and Health care worker state that the patient has taken irregular medication
* demonstrated cognitive understanding of the research plan and provided consent.

Exclusion Criteria:

* discharged from hospital for at least 3 months
* no intellectual disability, organic brain diseases or Cognitive impairment
* no alcohol or sub-stance abuse problems
* were not attending medication management program .
Health Protection and Promotion of Sign Language Interpreters Through Implementation of Total Worker Health®

Using mixed-methods and a clinical efficacy trial design, the overall objective of this study will employ implementation strategies to adapt and evaluate a previous integrated Total Worker Health® (TWH®) program and pilot test its efficacy on sign language interpreter well-being. The central hypothesis is that interpreters in the health protection and promotion program (intervention) will demonstrate significantly improved well-being compared to those in a general health program (control).


Eligibility Criteria:
Inclusion Criteria:

* Bilingual in English and American Sign Language
* Certified sign language interpreter working at least 10 hours/week in any interpreter setting.
* Apparently healthy

Exclusion Criteria:

* Less than 18 year old
* Not yet certified as a sign language interpreter
* Unable to provide consent