cyrilzakka/clinical-trials huggingface dataset:
Correct Endotracheal Tube Position in Newborns Intubated in the Delivery Room

The investigators wished to determine whether estimating endotracheal tube (ETT) insertion depth using the formula given by Spanish guidelines recommendations (5,5 plus weight) rather than the depth using the formula given by international guidelines recommendations (6 plus weight) resulted in more correctly positioned endotracheal tube tips in newborns intubated in the delivery room.

A number of different methods have been used to guide clinicians in estimating the correct depth of insertion of endotracheal tube (ETT) at the time of oral intubation. Minor differences in tube length may lead to intubation of the right main bronchus or extubation. However, none of them has shown to be better than others when compared in the context of randomized clinical trials.

Commonly, clinicians use a formula based on the newborn's weight (Tochen formula: ETT insertion depth (cm)=6 + wt (kg)). While this method is widely used and recommended by international guidelines, it has been found to frequently result in incorrectly positioned tubes, especially in infants \<1000 g in weight in whom it may lead to overestimation of ETT insertion depth.

On the other hand, Spanish Society of Neonatology recommended in their last published guidelines (2017) to use an alternative version formula (ETT insertion depth (cm)=5.5 + wt (kg)), which is commonly used among Spanish neonatal units.

Finally, no studies have been performed in newborns who require oral intubation in the delivery room, since these intubations are usually excluded because infants are not routinely weighed prior to resuscitation and weight can not be rapidly obtained. Given that Obstetric Unit in our hospital is a high standard one with a highly reliable estimated fetal weight in prenatal ultrasound, the investigators will use estimated fetal weight referred on ultrasounds or 50th percentile for gestational age for calculations.

Eligibility Criteria:
Inclusion Criteria:

* All newborns requiring endotracheal oral intubation in the delivery room after birth.
* Parents accept deferred informed consent to participate in the study.

Exclusion Criteria:

* Prior to randomization
* Uncontrolled gestation where both estimated fetal weight and gestational age are unknown.
* Upper airway anomaly or a lung anomaly that would distort the upper airway anatomy.
* Infants who require nasotracheal intubation
* Infants who are intubated in the Neonatal Intensive Care Unit
* Post-randomization
* Newborns who are randomized but finally do not require intubation
* Intubated newborns who are electively extubated in the delivery room
* Parents / legal guardian refuse to give consent to participate in the study
SEPREVEN: a Stepped-wedge Randomised Controlled Trial

Adverse events are frequent in Neonatal Intensive Care Units' (NICU) patients and account for a high morbidity and mortality. Possible severe adverse events are central line associated bloodstream infections (CLABSI), ventilator and catheter associated adverse events and medication errors. Severity of the patient's outcome after an adverse event can be classified using the National Coordinating Council for Medication Error Reporting and Preventing (NCC MERP) Index for categorizing medication errors.

The study will test the hypothesis that rates of adverse events in NICU patients will be reduced by the implementation of an educational program for the NICU caregivers (nurses and physicians), consisting of strategies for recognizing and preventing adverse events in their unit. These strategies will be oriented to prevent CLABSI, medication errors, skin and nasal complications and ventilator and catheter-associated adverse events.

This trial has a stepped wedge cluster design, in which the NICUs from 12 hospitals in France will be randomized to the timing of implementation of the educational program.

In order to describe the adverse events occurring during the study period, an anonymous voluntary adverse event reporting system will be provided to the caregivers of the participating units. A nested study will examine how caregivers communicate with the patients' parents in case of adverse event (disclosure or not, and caregivers' reasons).

The rates of adverse events will be measured retrospectively using a neonatal NICU trigger tool.


Eligibility Criteria:
Inclusion Criteria :

* Patients hospitalized during the study period in one of the 12 participating Neonatal Intensive Care Units
* Corrected Gestational age not exceeding 42 weeks +6 days at the time of admission in the NICU
* Length of hospitalisation in the NICU \> 2 days
* No parental objection to the anonymous data collection of their newborn(s)' clinical data, after written information

Exclusion Criteria:

* More than 42 weeks +6 days of corrected gestational age on admission in the NICU
* Length of hospitalization in the NICU \< or = 2 days
* Parental objection to the anonymous data collection of their newborn(s)' clinical data
Treatment of Bipolar Mania in Older Adults

This study will compare the benefits and side effects of lithium and divalproex in the treatment of older adults with bipolar mania.

This is the first controlled acute treatment study of bipolar disorder in adults 60 years or older with current DSM-IV manic, mixed, or hypomanic episodes. The number of older adults with severe and disabling bipolar disorder is increasing, and information to guide the management of the treatment of the disease is lacking in this population. Guidelines for treatment of younger people with bipolar disorder cannot be used for older people, and there are no safety and efficacy data upon which to base initial treatment decisions for older patients with bipolar mania. Mood stabilizers (lithium and divalproex) are the first-line treatment for bipolar disorder. However, in aged patients physiological changes and comorbid diseases may increase vulnerability to side effects and limit the benefits of the medications.

This double-blind study will compare the benefits and side-effects of 9 weeks of treatment with lithium and divalproex in people with bipolar mania. Participants, who may be treated during inpatient hospitalization or as outpatients, will be randomly assigned to receive either lithium or divalproex. During the first 3 weeks of treatment careful titration of lithium and divalproex will be done to reach dose ranges. All other psychotropic medications will be discontinued. Behavioral interventions and/or lorazepam may be added, if necessary. After the first 3 weeks, if symptoms do not improve, risperidone will be added to be taken everyday with the study medication.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DSM-IV Bipolar Disorder, Type I: current manic, mixed, or hypomanic episodes

Exclusion Criteria:

* Rapid cycling bipolar disorder
* History of substance abuse or dependence within last 3 months
* Diagnosis of schizophrenia or other chronic psychotic conditions
* Acute or unstable medical illness
* Documented intolerance to Lithium, Depakote, Risperidone, or Lorazepam
* Dementia
* Inability to communicate in English
The Effect of the Finger Feeding Method Premature Babies

This study aimed to determine the effect of the finger feeding method applied by fathers on the transition time to oral feeding and sucking success in premature babies.

Premature babies followed in the Neonatal Intensive Care Unit will be randomly divided into two groups: control group and finger-feeding group. Babies in the experimental group will be breastfed by their father three times a day. Before nasogastric feeding, the baby will be allowed to suck his finger by putting his finger in his mouth for five minutes three times a day. This procedure will be applied three times a day (morning, noon and evening) for a full 7 days. Babies in the control group will be given only routine ward care (breast milk or formula via tube without stimulation of the pacifier or mother's finger). Preterm Baby Monitoring Form and LATCH Breastfeeding Diagnostic Measurement Tool will be used to determine the transition time to oral feeding and breastfeeding success.

Eligibility Criteria:
Inclusion Criteria:

* Premature babies at 29-31 weeks
* Birth weight of 1300 g or more
* Those whose 1st and 5th minute Apgar scores are over 6
* Those whose vital signs and health status are stable
* In babies who have received mechanical ventilation and continuous positive air pressure support, those who have passed 48 hours after stability has been achieved
* No facial or oral anomalies
* Premature babies without swallowing difficulties
* Those fed via nasogastric tube
* Fathers who can read, write and speak Turkish
* Fathers of preterm babies who agreed to participate in the research.

Exclusion Criteria:

* Those whose vital and health conditions are unstable
* Those whose father has a skin condition or those who developed it later
* Any upper respiratory tract infection in the father
* Premature babies without swallowing difficulties
* Fathers who cannot read, write or speak Turkish
* Fathers with preterm babies who do not consent to this study will not be included in the scope of the research.
Gut Microbiome and Treatment for Gynecological Cancer Patients Receiving Immunotherapy

30 participants with advanced or recurrent gynecological cancer from are enrolled for this study. Eligible participants then provide fecal specimen, blood, vaginal swab, oral mucosal swab and receive food dietary recommendation. Additional samples are collected for results analysis.

30 patients diagnosed with advanced or recurrent gynecological cancer who plan to receive immunotherapy treatment with a checkpoint inhibitor at AHMG AdventHealth Orlando Gynecological Oncology Group are recruited. Patients will be recruited 1-2 weeks prior to the beginning of treatment and appropriate informed consent will be obtained. Fecal samples; blood; saliva and vaginal swab samples will be collected among participants prior to their first treatment, after four doses of immunotherapy, and again at the completion of immunotherapy (follow-up). These 4 biomarker samples will undergo metatranscriptomic analysis, also known as RNAseq, method of sample analysis. Only RNA molecules are sequenced, while DNA is degraded. for bacterial community analysis. These findings will help to design a future study to examine the role of the gut microbiome in antitumor immunity and its effect on immune checkpoint inhibitor therapy for advanced or recurrent gynecological cancer. NHANES Food Frequency Questionnaire will be collected prior to participants' first treatments.

The short-term goals of this pilot study are to obtain preliminary data on the gut bacterial microbiome of patients with advanced or recurrent gynecological cancer. The long-term goals of this study is to begin to understand how the gut microbiome changes within an individual patient undergoing immunotherapy, to gut microbiome differs among patients undergoing immunotherapy, and to examine whether the gut microbiome is associated with the response to cancer immunotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Adult females \> 18 years old
* Advanced or recurrent gynecological cancer patients from AHMG Advent Health Orlando Gynecologic Oncology Group
* Patients for whom an immunotherapy regimen has been ordered

Exclusion Criteria:

* Patients unable to provide fecal specimens at three time points
* Patients unable to read or understand informed consent
* Taking medications that may affect gut microbiome:

  * Proton pump inhibitors (PPIs)
  * Metformin
  * Antibiotics
  * Laxatives
* Patients who are receiving investigational agent
Long Term Results of the Canadian Breast IMRT Study

Women diagnosed with an early stage cancer of the breast usually have the cancer removed by lumpectomy and then have radiation treatments to the entire breast. In 2008 the investigators published the result of a multicentre study showing that breast Intensity Modulated Radiation Therapy (IMRT) significantly reduces the occurrence of radiation burns. In this study the investigators will recall all patients at 8 years to assess if this technique also reduces permanent side effects including pain and cosmesis.

In 2008 our group published the results of a multicentre, randomized, double-blinded study comparing standard radiotherapy to breast IMRT. The study showed a significant reduction moist desquamation using breast IMRT from 47.8% to 31.2% (p=0.002). There are two other Phase III trials showing improvement of long term cosmetic outcomes. Yet the use of breast IMRT remains not widely accepted. This trial aims at evaluating long term tolerance of breast IMRT compared to standard radiotherapy.

The investigators hypothesize that breast IMRT reduces the occurence of chronic breast pain (primary objective), improves cosmesis, reduces the occurence of delayed and permanent radiation induced skin side effects (telangiectasia, dryness, induration, edema, discolorations), improves quality of life. The investigators also hypothesize that there will not be differences in the local control rate or survival.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated in the Canadian Phase 3 randomised controlled trial breast IMRT trial

Exclusion Criteria:

* Patients declining participating to this study
* Patients unable to travel to the study site
* Patients deceased
Electromyography Evaluation of Subscapularis Function After Total Shoulder Arthroplasty

The primary objective is to document function of the structurally intact subscapularis after total shoulder arthroplasty by using electromyography. Structural integrity of the subscapularis will be confirmed using ultrasound.

The secondary objective is to determine the diagnostic accuracy of the belly compression and lift off tests in evaluating the integrity and function of the subscapularis when compared to the ultrasound and electromyography (EMG).

This will be accomplished by enrolling and evaluating patients with a primary diagnosis of osteoarthritis who have had a total shoulder replacement preformed by the PI from September 2003 through December 2007.

The functional status of the subscapularis following total shoulder arthroplasty has not been well documented. There is evidence of loss of subscapularis function shown through physical exam in up to 2/3 of patients following total shoulder arthroplasty. \[1\] Multiple techniques for subscapularis repair have been demonstrated with varying degrees of post operative function, ranging from 11-66% abnormal function on physical exam. \[1-3\] The belly compression test and the lift off test, which are the main physical exam tests used for evaluation following surgery, are of questionable reliability as indicators of the functionality of the subscapularis. \[4,5\] Through comparing ultrasound evidence of an intact subscapularis to physical exam findings it has been recognized that the belly compression test has low sensitivity and specificity for subscapularis integrity. \[5\] Internal rotation is often limited in many postoperative total shoulder patients, which could lead to false positive results. This questions the validity of the outcomes of the studies in which the standard of testing function was through exam.

Ultrasound is a reliable exam for illustration of structural damage to the subscapularis tendon but additional testing is needed to evaluate the function of the structurally intact subscapularis. \[5,6\] Irreparable changes in the muscle function or nerve denervation could also result in false positive belly compression and lift off tests. The ability to accurately determine the functionality of the subscapularis following total shoulder replacement is imperative to clinic management. Although studies have shown functional abnormalities through physical exam, none have documented the functional status of the subscapularis using objective means such as EMG.

Eligibility Criteria:
Inclusion Criteria:

* age \>45yrs;
* primary diagnosis of osteoarthritis of the shoulder
* total shoulder replacement performed by Dr. Armstrong between September 2003 through December 2007.

Exclusion Criteria:

* Known contraindications to ultrasound and/or EMG
* Inability to provide informed consent
* History of recent trauma to the shoulder
* Typical shoulder pain
* Other suspected shoulder pathology (i.e. tumor, infection)
* Pregnancy
* Bilateral total shoulder arthroplasty
Preputial Graft Versus Preputial Flap in Treatment of Proximal Hypospadias With Marked Ventral Curvature (a Comparative Study)

Hypospadias is a male congenital anomaly characterized by the abnormally located urethral meatus being displaced along the ventral side of the penis along a line from the tip of glans penis to the perineum.

Hypospadias is one of the most common congenital malformations of the male genitourinary system, with a reported global incidence of 0.6-34.2 per 10,000 live births. There is more than one classification for hypospadias. Most commonly, hypospadias is classified into proximal \& distal hypospadias which mainly affects the decision for the corrective procedure.

Correction of proximal hypospadias remains a surgical challenge, which is mainly due to the pathological features of proximal hypospadias including a more proximal meatus, severe ventral chordee, and the need to transect the urethral plate during the operation.

The use of a 2-stage repair was found to achieve more satisfactory functional and cosmetic outcomes for proximal hypospadias with severe ventral chordee . Bracka repair, first described in 1995 by Bracka, is a 2-stage repair which uses grafts. This procedure has been improved over time, and recently it has been associated with satisfactory outcomes in proximal hypospadias with severe ventral curvature. Staged transverse preputial island flap urethroplasty (STPIF), first reported by Chen et al., is another 2-stage repair using flaps based on the traditional transverse preputial island flap (TPIF). STPIF has been shown to reduce the difficulty of surgery and the complication rate in management of proximal hypospadias. Thus, both Bracka repair and STPIF are valuable 2-stage methods, and both have achieved promising results. However, there are no available clear comparative data for determination which method has a better outcome and less complications in treating proximal hypospadias.

This study compares Bracka's procedure using preputial grafts and STPIF (Staged Preutial Island Flap) procedure using preputial flaps in surgical correction of proximal hypospadias with marked ventral curvtaure.


Eligibility Criteria:
Inclusion Criteria:

* All patients with proximal hypospadias with marked ventral curvature (\>30 degrees) who presented to the outpatient clinic of Department of Pediatric Surgery in Sohag University Hospital.

Exclusion Criteria:

* Patients with insufficient follow up data or those who are non-compliant on follow up.
* Previously circumcised patients.
* Patients with complex urogenital malformations or DSD.
* Patients with ventral curvature less than 30 degrees.
* Patients with crippled hypospadias.
Effect of Hypoxia Exercise on Erythrocyte Aggregability

Pathological erythrocyte aggregation reduces capillary perfusion and oxygen transfer to tissue. The aggregation is determined by opposing forces, the repulsive force between cells, cell-to-cell adhesion induced by plasma fibrinogen, and the disaggregating shear force generated by blood flow. The investigators investigate how hypoxic exercise affects intrinsic/extrinsic factors of aggregation. Sixty sedentary males were randomly assigned into either hypoxic (HE; FiO2=15%, n=20) or normoxic (NE; FiO2=21%, n=20) training groups for 30 min·d-1, 5 d·wk-1 for 6 weeks at 60% of maximum work rate or to a control group (CTL; n=20). A hypoxia exercise test (HET, FiO2=12%) was performed before and after the intervention. The erythrocyte aggregation, binding affinity of fibrinogen and membrane biomarkers were determined by an ektacytometry and flow cytometry, respectively.

The aim of this study is to clarify the effects of exercise training with and without hypoxia on the erythrocyte aggregation, further providing a feasible strategy for developing an appropriate exercise regimen that improves cardiopulmonary fitness and minimizes the risk of hemorheological disorders. This study evaluated the distinct effects of hypoxic exercise training (HE) and normaxia exercise training (NE) for 6 weeks on the following issue: (1) intrinsic/extrinsic erythrocyte aggregation, (2) binding affinity of fibrinogen to erythrocyte, (3) erythrocyte turnover rate and (4) characteristic of mature erythrocytes in blood, under hypoxic exercise test (HET) (100W under air 12% O2 condition) in healthy sedentary men.

Eligibility Criteria:
Inclusion Criteria:

* Having a sedentary lifestyle (without regular exercise, exercise frequency ≤ once weekly, duration \< 20 min).

Exclusion Criteria:

* Exposed to high altitudes (\> 3000 m) for at least 1 year.
* Smoker
* Taking medications or vitamins
* Having any cardiopulmonary/hematological risk.
Accuracy of CADx System for White Light Colonic Polyp Characterization

The endoscopist performances in the optical diagnosis (OD) of colonic polyps with the available technologies vary widely across centers and across endoscopists. The OD process is strictly related to the operator training and expertise. Most of the available studies in optical characterization have been carried out by expert endoscopist in tertiary high volume centers, and weren't replied on large unselected populations. For these reasons, at the moment the optical characterization of polypoid lesions can't replace, in the everyday clinical practice, the histopathological evaluation of resected polyps. Artificial intelligence (AI)-based systems have the potential to make optical characterization process of colonic polyps easier and more reliable, thus supporting the endoscopist in the application of leave-in-situ and of resect-and-discard strategies. The implementation of such strategies would lead to a significant economic saving and a decrease of risks and complications related to unnecessary polypectomy. GI-Genius System (Medtronic Inc, Minneaopolis, USA) is a CNN-based algorithm allowing an automatic OD of colonic polyps. This system does not require dedicated light setting for polyp evaluation as it works with white light high definition images, which are the actual standard in every endoscopic unit. During colonoscopy, when a polyp is framed within the screen, a green detection box surrounds the polyp and the system automatically provides (whenever possible) the optical diagnosis labeling the polyp as "adenoma or non-adenoma". When the automatic polyp charaterization is unfeasible the label "no prediction" appears. Nowadays only few data about the feasibility and performances of this system in clinical practice are available. In addition published studies are mostly focused on technical rather thann clinical issues. The present prospective observational trial is primarily aimed at evaluating the diagnostic accuracy of optical characterization of colonic polyps \<= 1 cm using GI-Genius System in daily clinical practice, having histopathology examination as reference standard.


Eligibility Criteria:
Inclusion Criteria:

Consecutive outpatients undergoing colonoscopy for one of the following indication:

* FIT-based screening program
* voluntary screening
* post-polipectomy surveillance
* gastrointestinal symptoms
* family history of colorectal cancer.

Exclusion Criteria:

* urgent colonoscopy
* patients in which polyps could not be resected (e.g ongoing anticoagulation therapy)
* patients with past colorectal cancer or polyposis syndrome