cyrilzakka/clinical-trials huggingface dataset:
The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin

Primary: To determine the influence of daptomycin on inflammatory cytokine (IL-1, TNF and IL-6) for the treatment of complicated cellulitis/erysipela compared with alternative treatment (vancomycin or oxacillin). Secondary: To evaluate the clinical outcome of both groups according to levels of the cytokines evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Eligible patients will be age between 18 and 65 who required hospitalization and parenteral antimicrobial therapy
2. Clinical documentation of cellulitis / erysipela
3. Documentation of a minimal surface area 75 cm2 based on the length and / or width of the redness, swelling and / or induration
4. Documented fever, defined as oral or tympanic temperature greater than or equal to 38 ° C

Exclusion Criteria:

1. Infections and other minor addition of erysipelas / cellulitis
2. Any recent use of antibacterial drug therapy (systemic or topical antibacterial drugs within 14 days of enrollment)
3. Patients with clinical conditions that alter the interpretation of the primary outcome as patients with neutropenia or compromised immune function, as HIV infection, autoimmune disorders, use of corticosteroids.
4. Patients with known or suspected osteomyelitis.
5. Patients with suspected or confirmed septic arthritis.
6. Patients with complicated skin infections, such as diabetic foot infections. 7. Chronic use of antipyretic drugs (eg, daily use of naproxen).

8. Less than 18 years of age. 9. pregnancy 10. Patients with mixed infections of Gram-negative or be deleted since the therapy of gram-negative can influence the levels of cytokines.

11. Patients with renal clearance \<30 mL / min. 12. Patients who are not susceptible to daptomycin or vancomycin. 13. Allergy to study medication.
Correlation of Estimated Continuous Cardiac Output (esCCO) and TEE in Pediatric Cardiac Surgery

The purpose of this study is to determine the measuring accuracy of the truly non-invasive method estimated continuous cardiac output (esCCO) against the reference method transesophageal echocardiography in pediatric cardiac surgery. esCCO is calculated using the pulse wave transit time, which is defined as the time between the R-wave of the ECG and the 30% increase of the differentiated pulseoximetry waveform.

The objective is to compare two methods of cardiac output measurement in children: the new non-invasive method called esCCO™ (by Nihon Kohden, Tokyo, Japan) and the established more invasive method transesophageal echocardiography (TEE). esCCO™ is a completely non-invasive method that could provide a cardiac output measurement in a large range of pediatric patients because of an extremely low risk benefit balance.

Cardiac output monitoring has been technically challenging in pediatric patients. Available methods for measuring cardiac output in children are either inaccurate or highly invasive or limited to a small number of patients. So far esCCO™ has not been tested in the pediatric population but showed promising results when it was tested against the pulmonary artery catheter in adult patients undergoing heart surgery in previous Japanese studies.

Thus the validity of esCCO™ is now tested in pediatric patients scheduled for elective cardiac surgery. Transesophageal echocardiography has been chosen as reference method because it is performed routinely during pediatric cardiac surgery.

The algorithm for esCCO™ -measurement is integrated in an approved patient monitor that replaces the standard patient monitor during the measurement-period.

In the study protocol, events like esCCO™ -calibration time, catheter positioning time, ventilation settings, volume in- and output and drug administration, patients's data and diagnoses are logged. Vital parameters from the patient monitor including the esCCO™-cardiac output values are recorded every second in real time on a study laptop mounted on the same rack as the patient monitor but electrically separated from the other devices.

EsCCO™ measurements shall be compared to TEE cardiac output measurements at three given times: (1) before surgical intervention, (2) shortly after cardiopulmonary bypass and (3) after closure of the thorax.

A total of 50 patients shall be investigated in the study during a planned study time of approximately 6 months. The ethics committee of the University of Heidelberg gave their consent to the study (S-108/2012). For statistical analysis, a Bland-Altman-test for measurements with multiple values per patient, correlation graphics and a regression equation will be performed.

Eligibility Criteria:
Inclusion Criteria:

* written consent
* children \<=18 years
* elective cardiac surgery
* Sinus rhythm

Exclusion Criteria:

* no written consent
* continuous severe cardiac arrhythmias
* cardiac Pacemaker
* intraaortal balloon pump
* contraindications for TEE
* persistent ductus arteriosus botalli
Effectiveness of a Web-based Nursing Intervention in the Reduction of Postpartum Depression and Parenting Stress.

The purpose of the study is to determine whether a web-based nursing intervention delivered during the postpartum period will decrease symptoms of postpartum depression and parenting stress.

The purpose of this randomized, controlled trial is to determine whether receiving standardized messages (text or email) from a postpartum nurse four times/week for 6 months after delivery will decrease symptoms of postpartum depression and parenting stress. Enrolled women will be randomized to one of three groups. The first group will receive the usual care, which is a phone call from a nurse within the first few weeks postpartum. The second group will receive four standardized messages each week, the content of which will include infant care, maternal self-care and inspirational material. The third group will receive the same four standardized messages each week, and in addition, two of these weekly messages will offer the option to respond with a request for a nurse to call them. Baseline data will be collected during the postpartum hospitalization, and follow-up will occur by email at 3 weeks, 3 months and 6 months postpartum.

Eligibility Criteria:
Inclusion Criteria:

1. Able to speak and read English
2. Access to a device which can receive text or email messages

Exclusion Criteria:

1. Non-English speaking,
2. No access to a device which can receive text or email messages
3. Age younger than 18 -
Arthrocentesis Study

The purpose of this study is to analyze pre- and intra-operative joint aspirates of native joints and joints with suspicion of periprosthetic joint infection (PJI) of the hip, knee and shoulder acquired in clinical routine. Joint aspirates are then analyzed with new diagnostic methods (microcalorimetry, PCR, alpha-defensin, etc.). Diagnostic speed and accuracy of these methods is compared to standard diagnostic methods in clinical routine, such as blood cultures of joint aspirates, cell count/differential, intra-operative tissue culture and histology and sonication.

In this study, joint aspirate of patients that undergo joint aspiration in the context of routine pre- and intra-operative clinical diagnosis of a hip, knee or shoulder joint is collected. Routine joint punctures at our clinic are regularly performed in the emergency room, in the outpatient clinic and intra-operatively during diagnostic and revision surgery. A minimum of 5 ml aspiration fluid was required for inclusion in this study. Empty or diluted aspirations were excluded.

Joint aspirations are performed by orthopaedic surgeons with an 18-gauge needle according to standardized aseptic technique. Intraoperative punctures are performed prior to arthrotomy. A minimum of 1ml of joint aspirate is immediately transferred to a native study vial for our study, a native vial for gram stain and culture and a native vial for polarization microscopy, respectively. A minimum of 1 ml joint aspirate is transferred to an ethylenediaminetetraacetic acid (EDTA) vial for the determination of leucocyte count. Finally, a minimum of 1 ml is inoculated into a paediatric blood culture bottle.

Standard microbiological methods are performed in an external laboratory that routinely collaborates with our clinic. Leucocyte count is performed automatically with the mentioned EDTA vial. Polarization microscopy is performed at our pathohistological department in order to detect crystals and signs of infection in joint aspirate.

If written informational consent has been signed by the patient, the study vial is immediately transported to our internal laboratory for analysis with new diagnostic methods (microcalorimetry, PCR, etc.). When an immediate transportation was not feasible, the vial is stored in a cooling fridge at +3° C until transportation was possible.

Each case is individually reviewed and classified by an experienced infectiologist taking the case's clinical history and laboratory results into account.

Eligibility Criteria:
Inclusion Criteria:

* adult of 18 or more years
* written consent to participate in study
* suspicion of septic arthritis or periprosthetic joint infection
* joint aspirate minimum of 5 ml

Exclusion Criteria:

* is not able to understand the aim or purpose of this study
* empty joint aspirate
24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003, Open-Label Spiriva® Respimat® as an Active Control, and Placebo

Randomized, Phase IIIb, Three-period, Three-treatment, Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe COPD after 4 Weeks of Treatment with PT003, Open-Label Spiriva® Respimat® (Tiotropium Bromide) as an Active Control, and Placebo.


Eligibility Criteria:
Inclusion Criteria:

* At least 40 years of age and no older than 80 at Screening
* Women of non-child bearing potential or negative serum pregnancy test at Screening, and agrees to acceptable contraceptive methods used consistently and correctly Screening until 14 days after final visit.
* Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
* Current or former smokers with a history of at least 10 pack-years of cigarette smoking
* Pre- and post-bronchodilator FEV1/FVC ratio of \<0.70
* Post-bronchodilator FEV1 must be \<80% predicted normal value, calculated using NHANES III reference equations, and the measured FEV1 must also be ≥750 mL if FEV1 \<30% of predicted normal value.

Exclusion Criteria:

* Significant diseases other than COPD, i.e., disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
* Women who are pregnant or lactating.
* Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
* Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Screening or during the Screening Period.
* Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Screening or during the Screening Period.
* Subjects who have clinically significant uncontrolled hypertension.
* Subjects who have cancer that has not been in complete remission for at least five years.
* Subjects with abnormal liver function tests defined as AST, ALT, or total bilirubin ≥1.5 times upper limit of normal at Screening and on repeat testing.
* Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible.
* Subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator. Subjects with a trans-urethral resection of prostate (TURP) or full resection of the prostate within 6 months prior to Screening are excluded from the study.
* Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator.
Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis

The purpose of this study is to investigate which changes in immunological biomarkers under treatment with fingolimod in patients with relapsing-remitting multiple sclerosis can be detected.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with relapsing forms of MS defined by 2005 revised McDonald criteria
* Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5

Exclusion Criteria:

* Patients with a manifestation of MS other than relapsing remitting MS
* Patients with a history of chronic disease of the immune system other than MS such as known immunodeficiency syndrome
* History or presence of malignancy in the last 5 years
* Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients
* Diagnosis of macular edema during Screening Phase
* Patients with active systemic bacterial, viral or fungal infections
* Negative for varicella-zoster virus IgG antibodies at Screening
* Patients who have been treated with cladribine, cyclophosphamide or mitoxantrone at any time
* History of cardiovascular disorder
* Women of child-baring potential and inadequate contraception

Other protocol-defined inclusion/exclusion criteria may apply
A Protein-sparing Modified Fast for Children and Adolescents With Severe Obesity (PSMF)

This is a 12 month prospective observational cohort study of the outpatient protein-sparing modified fast diet for children with severe obesity and serious comorbid condition(s). The study will enroll 30 Center for Healthy Weight and Nutrition patients aged 11-19 years who have been placed on a protein sparing modified fast as part of their treatment plan. The study-specific procedures consist of questionnaires/interviews on diet and PA behaviors, adherence and self-efficacy measures, data abstraction from the chart and tracking of activity using a Fitbit.

Aggressive dietary interventions may provide an accessible treatment option for children and adolescents with severe obesity who are not successful with traditional lifestyle behavioral interventions or do not want or qualify for weight loss surgery. One such intensive dietary option is the protein sparing modified fast (PSMF). The PSMF involves minimal carbohydrate intake to induce ketosis, while maintaining adequate or high protein intake to minimize catabolism. The PSMF, under medical supervision, can be an effective and safe intervention for children and adolescents, yet the PSMF diet is not regularly used in the treatment of pediatric severe obesity. This pilot study will employ a prospective cohort study design. Thirty children, 11-19 years-old, with severe obesity, who have been prescribed the rPSMF as part of their treatment in a tertiary care pediatric weight management clinic (PWMC), will be recruited along with their attending parent to participate in the study. The primary aim of the study is to evaluate the acceptability of the rPSMF as assessed by adherence, satisfaction with the intervention, and participation rate using quantitative and qualitative methods. The secondary aim is to investigate the effectiveness of the rPSMF on improving a) anthropometric measures (weight, body mass index \[BMI\] and BMI z-score); b) metabolic measures (lipid profile, glycosylated hemoglobin, liver function tests); and c) quality of life. Results of this study will provide guidance for the standardization of a pediatric rPSMF protocol in a clinic setting, delineate which factors improve or hinder adherence and weight loss and provide preliminary data for a multicenter randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Children Age 11-19 years old
* Must be severely obese (BMI greater than or equal to 120% of the 95th percentile for their age and sex, or a BMI of 35 or greater)
* Must have at least one severe comorbidity
* Tanner Stage III, IV, V

Exclusion Criteria:

* non-English speaking
* Patients without adequate social/psychological capacity, as evidenced by unavailability to recourses, or family is unable to provide support.
Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial

The purpose of this study is to investigate the effect of an early, coordinated rehabilitation intervention for patients with severe heart failure in NYHA class III and IV with a ejection fraction of \<40% of normal cardiac function measured on frequency of readmissions, physical ability and participation in activities of daily living and quality of life.

Approximately 400,000 Danes live today with heart disease. Disease severity is crucial for patients quality of life. Patients with severe heart disease often struggle with everyday life, characterized by reduced physical capacity, tendency to depression and anxiety to perform everyday activities that may provoke symptoms.

A large proportion of patients who are offered cardiac rehabilitation deselect that offer. Of the patients who do participate, more than 50% stop the rehabilitation ahead of time. A large group of patients with severe heart failure and classified in NYHA Class III and IV, deselect the offer because of lack of energy to participate in cardiac rehabilitation or is when specified by a medical assessment discharged from the hospital without the offer of training or any other form of rehabilitation.

The offer of rehabilitation for patients with severe heart failure is lacking as it is today. This study assesses the effectiveness of an early home based rehabilitation program that complements the general psycho-social support, symptom-oriented and preventive medical treatment that these patients always have the option to get.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the Gentofte Hospital due to heart failure.
* Patients with a functional equivalent to NYHA grade III or IV
* Patients with ejection fraction \<40%
* Patients who score between10-15 in the total score for question 3 dealing with physical functioning in SF-36 questionnaire on health status
* Patients who lives in Gentofte Municipality or Lyngby Tårbæk Municipality.
* Patients who can speak and understand Danish

Exclusion Criteria:

* Patients with cognitive and psychological problems that prevents cooperation (aphasia, dementia, severe depression).
* Patients with terminal illness with expected death within a year.
The Effect of Combined Use of Anti-fibrotic Agent With Platelet Rich Plasma on Skeletal Muscle Healing After Acute Injuries

The aim of this comparative study is to determine whether or not LOSARTAN with its anti-fibrotic action has an added effect when administrated with platelet rich plasma injection on skeletal muscle healing and on decreasing the fibrous scar after muscle injuries in comparison with the sole administration of platelet rich plasma.


Eligibility Criteria:
Inclusion Criteria:

* Adult age. (18 - 40 year old).
* Clinically diagnosed acute skeletal muscle injury with maximum 3 days duration and ultrasonographically confirmed grade II according to Woodhouse et al.
* Understanding the study and accepting the participation

Exclusion Criteria:

* Any connective tissue disease (e.g. rheumatoid arthritis, systemic lupus erythematous, etc.)
* Hypertension or hypotension
* Diabetes mellitus
* Any cardiac or pulmonary disease
* NSAIDs use in less than a week prior to the beginning of the study.
* Muscle injuries requiring surgical interference.
* No detectable injury ultrasonographically.
* Anemia
* Thrombocytopenia or any platelet disorder.
* Pregnancy or lactation.
* Local infection
Perioperative Hyperoxygenation and Wound Site Infection Following Surgery for Acute Appendicitis

Patients undergoing open appendectomy for acute appendicitis were enrolled in a randomized prospective study.


Eligibility Criteria:
Inclusion Criteria:

* Consent was given
* 15 years old or older
* Underwent acute appendicitis

Exclusion Criteria:

* Lack of follow up
* Younger than 15 years
* Not eligible according to physician decision
Evaluation of Cardiotoxic Effects of Bortezomib

The purpose of this study is to learn more about how a drug commonly used to treat multiple myeloma can affect the heart.

In this study, the investigators will learn whether a drug called how a drug (called bortezomib, or Velcade) receive for multiple myeloma affects the heart. Bortezomib is part of the standard treatment and its effects on multiple myeloma is not being studied here.

The investigators want to learn whether damage occurs to the heart after taking bortezomib for multiple myeloma, whether it is reversible, and we can predict damage to the heart before it occurs.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of multiple myeloma
* have a treatment plan involving greater than 4 cycles of bortezomib-based chemotherapy

Exclusion Criteria:

* pre-existing history of left ventricular systolic dysfunction
* congestive heart failure
* coronary artery disease
* significant valvular heart disease
* cardiac arrhythmias
* estimated glomerular filtration rate \<30 mL/min/1.73m2
RELAX Anaesthetics: the Effect of a Bespoke Relaxation App on Stress Levels in Children Undergoing Anaesthesia

RELAX Anaesthetics is a randomised clinical trial assessing the effectiveness of using an iPad app with art, music and games to relax and distract children, reduce anaesthetic induction time and make drug cost savings prior to surgery.

The most distressing part of a parent's experience in hospital is watching a child undergo intravenous cannulation.1 This is commonly performed in the anaesthetic room prior to induction of anaesthesia. At Chelsea and Westminster Foundation Trust (CWFT) over 5000 children undergo operations every year. Traditional methods of distracting the child during have included blowing bubbles, storybooks, and a variety of toys and games. These methods are not always effective and may present an infection risk due to inability to clean between uses.

The use of an android/iPad provides a platform for effectively distracting the child with a choice of games, video and music, with the advantage of being cleaned between uses. Users of this platform are required to select the application that is most appropriate for the age, sex, method of anaesthesia, and compliance level of the child. To assist with this, the investigators have developed an application system that will select a range of entertainment applications appropriate for each child based on these four variables and hopefully help to keep children calm before their operations.

Eligibility Criteria:
Inclusion Criteria:

* children ages 2 -12 years
* requiring general anaesthesia
* ASA assessment of fitness for surgery score 1 - 3

Exclusion Criteria:

* intravenous cannula already in situ
* play therapist already in use
* anaesthetist refusal to participate
* parental / patient refusal to participate
* sedative or opiate pre-med already administered
* not requiring general anaesthesia
* ASA assessment of fitness for surgery score 4 or 5