cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Umbilical Cord Cleansing With a Single Application of 4% Chlorhexidine for the Prevention of Newborn Infections in Uganda: a Randomized Controlled Trial

Background: Nearly all the yearly 3.3 million neonatal deaths occur in low and middle income countries. Infections, including those affecting the umbilical cord (omphalitis) are a significant factor in approximately a third of these deaths. In fact, the odds of all-cause mortality are 46% higher among infants with umbilical cord infection than those without infection. Five large randomized controlled trials in Asia and Sub-Saharan Africa have examined the effect of multiple applications (for at least 7 days) of 4% chlorhexidine (CHX) on the umbilical cord on omphalitis and neonatal death. These studies show a consitent positive effect of multiple applications on omphalitis but not on neonatal mortality. Whereas there is mounting evidence for the effect of 7 day chlorhexidine application, there is no data from Africa and only one study from Asia that examines the effect of a single application of CHX as soon as possible after birth. In this single Asian study, CHX led to a reduction in the risk of mild-moderate omphalitis and neonatal death. It is important, in an African setting to explore the effect of a single application, which is programmatically much simpler to implement than daily application for 7 days. Therefore, the investigators' study will compare umbilical cord cleansing with a single application of 4% chlorhexidine at birth with dry cord care in both community and facility births on omphalitis and severe illness in the neonatal period.

Methods: The chlorhexidine study is a community based, individually randomised controlled trial conducted on 4,760 mother-infant pairs in Uganda. The primary outcomes are severe illness and umbilical cord infection (omphalitis). Severe illness is defined as any illness associated with at least one of the following danger signs observed by study research assistants: inability to drink or breastfeed or (a history of) convulsions, lethargy or unconsciousness, vomiting of all feeds, and/or results in hospitalization and/or results in death.

Discussion: This study will provide novel evidence, from a Sub-Saharan African setting of the effect of umbilical cord cleansing with a single application of 4% chlorhexidine at birth in both community and facility births.


Eligibility Criteria:
Inclusion Criteria:

* Newborns weighing 1.5kg or more at birth
* Newborns born to mothers whose HIV I status is negative

Exclusion Criteria:

* Newborns with severe congenital anomalies
* Newborns with infection of the umbilical cord at birth
* Twins or triplets
* Severely ill infants requiring hospitalization immediately after birth
* Children of mothers who cannot appropriately give consent within 12 h of birth
Dose Ranging Study of the Salmeterol Component of Fluticasone /Salmeterol Spiromax Compared to Fluticasone Spiromax and Advair Diskus in Asthma Subjects

The primary objective of this study is to evaluate the dose response, efficacy, and safety of 4 different doses of salmeterol Spiromax (6.25, 12.5, 25, and 50 mcg) each combined with a fixed dose of fluticasone propionate (100 mcg) delivered as Fluticasone/Salmeterol Spiromax® Inhalation Powder (FS Spiromax) when administered as a single dose in subjects 12 years of age and older with persistent asthma.

This was a multicenter, randomized, double-blind and open-label active-controlled, single-dose, 6 period crossover, dose-ranging study conducted in male and female subjects ages 12 years and older with persistent asthma.

Fluticasone propionate multidose dry powder inhaler (Fp MDPI) 50 mcg was provided (to replace the subject's current inhaled corticosteroid (ICS)) throughout the 14 day run-in period and each of the washout periods between treatments. Subjects were instructed to administer 2 inhalations of Fp MDPI 50 mcg (100 mcg total dose) twice daily during the run-in and washout periods. All other medications for the treatment of asthma were discontinued at or prior to the screening visit.

A short-acting β2-adrenergic agonist (SABA), salbuterol HFA, MDI, was provided (to replace the subject's current rescue medication) for symptomatic relief of asthma symptoms in each the run-in, treatment, and washout periods.

Treatment period lasted 5 weeks with a 5 to 7 day washout between each of the six single dose treatments:

* fluticasone propionate/salmeterol xinafoate multidose dry powder inhaler (FS MDPI) given in doses of 6.25, 12.5, 25, or 50 mcg of salmeterol xinafoate in blinded fashion.
* fluticasone propionate multidose dry powder inhaler (Fp MDPI) 100 mcg in blinded fashion
* ADVAIR DISKUS, 100/50 mcg in open-label fashion

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent/assent
* General good health
* Diagnosis of asthma as defined by the National Institutes of Health (NIH)
* A best FEV1 of 40%-85% of the predicted normal value during the screening visit (SV)
* Subjects need to demonstrate a ≥ 15% reversibility of FEV1 within 30 minutes following 4 inhalations of albuterol inhalation aerosol (if required, spacers are permitted for reversibility testing) at the SV.
* Other inclusion criteria apply

Exclusion Criteria:

* History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation.
* Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks prior to the SV.
* Any asthma exacerbation requiring oral corticosteroids within 3 months of the SV. A subject must not have had any hospitalization for asthma within 6 months prior to the SV.
* Taking long-acting β-agonists within 2 weeks of the SV
* Other exclusion criteria apply.
Evaluating Liking, Acceptability and Health Benefits of Grain Products

The specific aims of the Grain Study are to determine if exposure to different types of grain products, over a period of 6 weeks, changes liking and acceptability and to determine if the gut microbiota, bacterial fermentation products, or gastrointestinal function changes with consumption of whole grains or refined grains.

Subjects will be recruited in accordance with inclusion and exclusion criteria listed below. Subjects will be assigned to one of two different grain product 'exposure' groups - Group 1 will receive predominantly Whole Grain (WG) products and Group 2 will receive predominantly Refined Grain (RG) products (ratio of WG to RG assignment will be 2:1). For a 6-week exposure period, subjects will receive weekly market baskets of grain products consisting of breakfast cereals, breads, snack items, and side dishes with the target of providing whole grains at a level of 85% of grain intake for the WG group (this exceeds the current Dietary Guideline recommendation of 50%) and 15% for the RG group (this is the current estimated intake for U.S. adults). Before and after grain exposure, subjects will rate the acceptability and liking of numerous grain products. To accomplish this, subjects will participate in sensory evaluation tests using these products, and they will provide information using validated questionnaires and take implicit association tests. During the 6-week study period, subjects will record use of the market basket grain products, and provide subjective scores for taste, convenience, nutrition, and general liking. The quality of the total dietary intake will be assessed using unannounced 24-h recalls. Biological samples will also be collected from subjects. Blood and urine samples will be collected to evaluate risk factors of chronic disease, and biomarkers of whole grain intake, fruits and vegetables. Saliva and fecal samples will be collected to measure changes in gut microbiota and to measure metabolites of bacterial fermentation. Breath hydrogen tests will be conducted to measure bacterial fermentation. Two weeks after the end of the intervention period, subjects will participate in a nominal group session to identify significant barriers and facilitators to inclusion of grain products into their diets.

Eligibility Criteria:
Inclusion Criteria:

* 20-45 years of age
* male or female
* consumers of 1 or fewer whole grain products per day

Exclusion Criteria:

* Type I or II Diabetes or glucose intolerance
* Preference for whole grains
* Do not cook at home
* Pregnant or planning to be pregnant
* Smoking
* Chronic inflammatory bowel disease
* colorectal cancer
* Celiac disease or gluten sensitivity
* Crohn's disease
* Regular use of colonics and/or laxatives
* body weight change of \>3% in last 6 months
* use of antibiotics, appetite suppressants, mood altering medications, and regular tobacco use.
A Pharmacokinetic Study of an Experimental Paracetamol Formulation

This PK study is designed to show bioequivalence between the study treatments.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer

Exclusion Criteria:

-
SAFEty Study of Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury (SAFE EVICT CORONA-ALI)

This study will evaluate the safety of a 96-hour intravenous vitamin C infusion protocol (50 mg/kg every 6 hours) in patients with hypoxemia and suspected COVID-19.

The intravenous vitamin C treatment protocol will be comprised of four intravenous infusions a day, that is 50 mg/kg every 6 hours in patients with laboratory-confirmed SARS-CoV-2 infection manifesting COVID-19 (Novel Coronavirus Disease 2019) with hypoxemia. Treatment protocol will continue for 4 days (96 hours), and, if needed, the last study-specific bloodwork with being collected on day 7. All subjects will be followed to day 28 (phase I) and day 90 (phase II) for collection of clinical outcomes data through electronic health records (EHR) even though the treatment protocol will be completed by 96 hours from randomization at the latest. Secondary outcome data will also be collected either during in-person (clinic) visit or via telephone at the 60 and 90-day follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Adults of 18 years or older
* Patients hospitalized with a diagnosis of COVID-19 based on central laboratory-confirmed COVID-19 Novel Coronavirus Disease-2019, based on a positive SARS-CoV-2 RT-PCR confirmed within 72 hours prior to enrollment of nasal, oropharyngeal, or BAL specimen with hypoxemia, (i.e., decrease in oxygenation, as outlined below)
* Pulse oximetry saturation (SpO2) \< 93% on room air in WHO COVID-19 ordinal scale 3 patients, regardless the need for assisted ventilation, or oxygenation.
* Any new requirement of supplemental oxygen, with any oxygen device (WHO COVID-19 ordinal scale 4-7, regardless of pulse oximetry reading)
* In patients with supplemental oxygen at home, any increase in the requirement of supplemental oxygen.
* In ICU level care

Exclusion Criteria:

* Age less than 18 years
* Known allergy to Vitamin C
* Inability to obtain consent from patient or next of kin
* Presence of diabetic ketoacidosis
* ANY history of oxalate stones at any time
* Patients with Kidney Disease Improving Global Outcomes (KDIGO), CKD stage 4 (eGFR \< 30 ml/min, CKD stage 5 and end-stage renal disease on dialysis patients are excluded.
* Patients with Acute Kidney Injury, stage 3.
* Pregnant, or lactating
* Known diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Patients who received the following medications within 7 days prior to enrollment, or plan to receive during enrollment, or 7 days after enrollment: aluminum hydroxide, bortezomib, copper, deferoxamine, amphetamines including derivatives such as fluphenazine.
* Patients with active sickle cell crisis
* Prisoners
* Patients outside ICU level care
Comparative Study of Fixation or Fusion of Calcaneal Fractures

A multicentre randomized controlled trial that will be conducted at Level 1 trauma centres across Canada. It will compare patients who receive open reduction, internal fixation for Sanders IV calcaneal fractures to patients who receive primary subtalar fusion for the same type of fracture. Patients will be followed up for a period of two years from the time of operation with evaluations being performed at 5 time points: 6 weeks, 3 months, 6 months, 12 months, and 24 months.


Eligibility Criteria:
Inclusion Criteria:

* patients with Sanders IV displaced intra-articular calcaneal fracture
* males and females aged 16-59 inclusive
* ability to provide informed consent
* available for follow-up for at least 2 years after injury

Exclusion Criteria:

* medical contraindications to surgery
* previous calcaneal pathology (infection, tumor, etc)
* co-existent foot or ipsilateral lower limb injury
* open calcaneal fracture
* injury greater than 3 weeks old
* head injured patients
* inability to obtain pre-operative CT scan or accurately classify the fractures according to the Sanders classification system
* inability to comply with advice to diminish smoking after the injury
* metal allergy
* extremely comminuted intra-articular fractures of the calcaneus deemed impossible to reconstruct by the treating surgeon
* any concerns either by the treating surgeon or patient about harvesting autograft needed for fusion
RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate

This is a Phase IV, prospective, open-label, multi-center trial to assess the treatment satisfaction in patients with relapsing forms of Multiple Sclerosis (MS) who are currently being treated with, but are considering discontinuing treatment with Tecfidera™.


Eligibility Criteria:
Key inclusion Criteria:

* Diagnosis of relapsing form of MS
* Have declared a desire/plan to discontinue treatment with Tecfidera due to tolerability issues and/or lack of efficacy
* Expanded Disability Status Scale (EDSS) score 0 to 5.0 inclusive
* Other protocol defined inclusion criteria could apply

Key exclusion Criteria:

* Pregnant or lactating
* Significant renal or hepatic impairment or other significant disease that would compromise adherence and completion of the trial
* Other protocol defined exclusion criteria could apply
Zona Pellucida Thinning Versus Drilling During Laser-assisted Hatching

Two hundred cycles will be enrolled (100 laser-assisted thinning and 100 laser-assisted drillings).

They will be compared regarding the implantation and clinical pregnancy rates

Two hundred cycles will be enrolled (100 laser-assisted thinning and 100 laser-assisted drillings).

All study participants will undergo controlled ovarian stimulation by GnRH agonist long protocol starting from mid-luteal phase. The complete pituitary suppression will be confirmed by serumE2 level less than 30 pg/ml and serum LH level less than 2 mIU/ml, then gonadotropin therapy will be started from day 2 to the day of maturation confirmed by the presence of 3 mature follicles or more, one of them 18 mm; at this time 10000 IU of hCG will be administered then ovum pick up done 36 hours after hCG administration under transvaginal ultrasound guidance Cumulus cell masses around the oocytes will be removed using pull-and-cut denudation pipettes in a 5-well culture dish (MTG, Bruckberg, Germany) containing 27 IU/mL of hyaluronidase.

All oocytes that will be mature at 4-6 h after oocyte collection will be inseminated according to the quality of the spermatozoa and oocytes and the patient's previous IVF history. Fertilization will be confirmed 17-18 h after insemination by the presence of two distinct pronuclei. Zygotes will be cultured in 30-μL micro-drops with a 1-step medium and overlaid with paraffin oil in an atmosphere of 6% CO2, 5%O2, and 95% humidity at 37 °C. The available embryos will be assessed in all patients according to the criteria of equal and regular blastomeres, a viable blastomere number, and fragmentation ratio.

LAH will be conducted using a Laser System with a 1.48-μm diode-laser at 300 m W through thinning or drilling. The embryos will undergo either LAT or LAD in 10- to 20-μL micro-drops consisting of G-MOPS plus medium. The embryos will be fixed in the micro-drops on the inverted microscope. The size of one laser shot will be 5μm in the ZP using the same total number of 3000-μs pulses. In LAT, the goal of the thinning method is to make the outer portion of the outer protective glycoprotein layer thinner. The laser thinning will be performed by making 2-3 holes without reaching the inner membrane at a depth of60-80% of the ZP thickness. In LAD, the laser opening will be made from the outside to the inside of the ZP.

The laser beam shot towards the ZP above the perivitelline space between two blastomeres to minimize the risk of harming the embryo, under careful control. The embryos in the micro-drop will be washed several times after LAH and then transferred to a 1-well dish (Falcon 353,653, USA) containing G-2 culture medium. LAH was performed 2 to 3 h before embryo transfer. The embryos will be cultured in an atmosphere of 6% CO2, 5% O2, and 95% humidity at 37 °C.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have a previous ICSI failure, unexplained infertility or male infertility

Exclusion Criteria:

* Patients with hydrosalpinx, pyosalpinx, endometriosis, or uterine fibroids
Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old

This study is conducted among people aged 18-50 in Dandong City, an area with a high incidence of hepatitis A in recent years. 1000 qualified pariticipants with signed informed consent will be screened for anti-HAV antibodies by collecting blood sample of 3ml. One dose of hepatitis A vaccine will be administrated to all the pariticipants. Negative anti-HAV antibodies-negative subjects will recieve the second dose of hepatitis A vaccination, and 400 of them will be randomly selected and assigned to 4 groups with different interval of vaccination(6 month, 18 months, 36 months and 60 months). Blood samples will be collected before vaccination of each dose and on 28 days after each dose of vaccination to anti-HAV antibody test. Safety data will be collected within 28 days after each vaccination with a smartphone mini-program.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-50;
* Adults can understand and sign the informed consent form voluntarily;
* Adults can provide valid and legal identity certificate.

Exclusion Criteria:

* A history of hepatitis A infection;
* Previously vaccinated with inactivated hepatitis A vaccine, live attenuated hepatitis A vaccine, or hepatitis A and B combined vaccine;
* Allergic constitution or have severe allergic reaction to vaccines in the past (such as acute allergic reaction, angioedema, dyspnea, etc.);
* Pregnant women and lactating women;
* People suffering from uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain-Barré syndrome, demyelinating diseases, etc.);
* Patients with fever during vaccination, or acute exacerbation of chronic diseases, or patients with uncontrolled severe chronic diseases, or suffering from acute diseases;
* Received other research drugs within 30 days before vaccination with the experimental vaccine;
* Have received a live attenuated vaccine within 14 days before vaccination with the experimental vaccine;
* Have received subunit or inactivated vaccine within 7 days before vaccination with experimental vaccine;
* Other conditions that are not suitable for vaccination judged by the researcher.
Intensive Care Unit Risk Score

Subject of the planned project is the retrospective analysis of routine data of digital patient files of the Department for Anaesthesiology and Surgical Intensive Care Medicine, to test whether the predictive values of intensive care scoring systems with regard to perioperative mortality and morbidity can be improved by continuous score calculation and by using machine learning and time series analysis methods.

A scoring system usually consists of two parts - a score (a number reflecting the severity of the disease) and a probability model (equation indicating the probability of an event, e.g. the death of the patient in hospital). Scoring systems have been used in intensive care medicine for decades and can help to assess the effectiveness of treatment or identify comparable patients for study purposes. Scoring systems that are used in intensive care medicine are for example

* Acute Physiology, Age, Chronic Health Evaluation II (APACHE II)
* Simplified Acute Physiology Score II (SAPS II)
* Multiple Organ Dysfunction Score (MODS)
* Sequential Organ Failure Assessment (SOFA)
* Logistic Organ Dysfunction System (LODS)
* MPM II-Admission (Mortality Probability Models (MPM II)
* Organ Dysfunction and Infection score (ODIN)
* Three-Day Recalibrating ICU Outcomes (TRIOS)
* Glasgow coma score (GCS)
* Discharge Readiness Score (DRS) The above-mentioned scoring systems are already being collected regularly in the respective hospital's departments. In a recent study by Badawi et al. it could be shown that scoring systems allow more accurate predictions when calculated continuously. However, due to the patient collectives investigated, these results can only be transferred to other patient groups to a limited extent. Furthermore, only the scoring systems APACHE, SOFA and DRS were analyzed.

Therefore, in the present study, all of the above scoring systems will be calculated continuously (once per minute) using routine data from the digital patient records and optimized by applying machine learning and methods of time series analysis.

On the anesthesiologically managed intensive care units of the respective hospital, there is no campus-wide standard with regard to alarm management. Accordingly, we estimate the rate of alarm fatigue (ignoring alarms due to many false alarms) to be very high. In order to optimize the alarm management, alarms from the patient monitoring devices will be evaluated retrospectively and combined with the data mentioned above to determine, for example, whether more frequent alarms are to be expected for certain types of diseases (e.g. sepsis), or scores (e.g., high APACHE score) and how the alarm limit setting can be optimized.

Eligibility Criteria:
Inclusion Criteria:

- Patients with admission between 01.01.2006 and 30.09.2023

Exclusion Criteria:

* Patients under 18 years of age.
* Incomplete patient records.
* Intensive stay of less than 24 hours.
Electrical Velocimetry (ICON Cardiometry ) Assessment of Hemodynamic Changes During Pediatric Thoracoscopic Surgery

Advances in endoscopic equipment and technique have led to the use of minimally invasive thoracic surgery in an increasing number of pediatric surgical procedures. Logically, thoracoscopic surgery and anesthesia can induce significant physiologic changes,, derangements of normal respiratory physiology induced by the surgical approach and the installation of carbon dioxide into the thoracic cavity can lead to alterations of normal acid-base status. Finally, surgical procedures in the chest, surgical traction or insufflation pressures impairs venous return and/or cardiac function, especially in neonates and infants. In this study Electrical Cardiometry TM (ICON, Cardiotronic/Osypka Medical, Inc., La Jolla CA, USA) is used assess the effect of different intra-thoracic pressure (insufflation pressures 4,5 \& 6 mmHg) during thoracoscopic surgeries in neonates and infants on hemodynamics using electrical velocimetry (ICON) as non-invasive monitoring technique.


Eligibility Criteria:
Inclusion Criteria:

1. ASA physical status I-II.
2. Age neonates and infants
3. Children undergoing thoracoscopic surgery surgeries.

Exclusion Criteria:

1. Parents' or guardians' refusal.
2. Left lateral positioning
3. Congenital heart diseases.