cyrilzakka/clinical-trials huggingface dataset:
The Need of Fiberoptic Bronchoscopy for Placing an Endobronchial Blocker

The need of fiberoptic bronchoscopy for placing an endobronchial blocker. Endobronchial blockers (EBB) have been presented effective and safe alternative for lung separation in vedio-assisted thoracoscopic (VATS) operations. In this study, the investigators will randomize the patients receiving VATS operation with EBB into two groups: one group will receive the conventional bronchoscopic guided EBBs placement, the other group receive two step procedure without confirmation by fiberoptic bronchoscopy.

The need of fiberoptic bronchoscopy for placing an endobronchial blocker. Endobronchial blockers (EBB) have been presented effective and safe alternative for lung separation in vedio-assisted thoracoscopic (VATS) operations. However, there were previous reports showed that it takes longer time to position the EBB versus the double lumen tubes. Placing EBBs need three-step procedure (one is placing an endotracheal tube, the second is inserting the EBB, the third is confirmation of the position by fiberoptic bronchoscopy). In this study, the investigators will randomize the patients receiving VATS operation with EBB into two groups: one group will receive the conventional 3-step procedure, the other group receive two step procedure without confirmation by fiberoptic bronchoscopy.

Eligibility Criteria:
Inclusion criteria:

Lung separation by endobronchial blockers

Exclusion criteria:

Lung separation by conventional double lumen tube Lung separation with endobronchial blockers through
Epidemiology of Cardiotoxicity in Children With Cancer

To provide a comprehensive analysis of risk factors for the development of clinical cardiotoxicities in over 6,000 children with cancer who had been treated on standardized protocols involving the use of anthracyclines alone or in combination with other potentially cardiotoxic therapies or with no use of anthracycline therapy.

DESIGN NARRATIVE:

The data were analyzed to estimate the incidence of clinical cardiotoxicity as measured by sudden death, congestive heart failure, or discontinuation of therapy based on cardiac function. Evaluation of patient characteristics (age, anemia) and treatment factors such as drug, dose level, dosing schedule, exposure to irradiation and/or cyclophosphamide identified groups at particularly high risk for development of clinical cardiotoxicity and provided estimates of this risk for future treatment planning. Such estimates of high risk groups should make possible future trials to test the feasibility of using cardioprotectors or alternate dosing schedules to prevent cardiotoxicity. The incidence of clinical cardiotoxicity was calculated using Kaplan- Meier estimates as a function of total cumulative anthracycline dose and also as a function of the time since the end of treatment stratified by dose levels. The estimates were stratified by exposure to cyclophosphamide and radiation therapy. Multivariate methods were used to evaluate the prognostic significance of selected patient characteristics and treatment parameters and to provide estimates of the relative risk of each variable. The method of recursive partitioning was used to identify subpopulations at elevated risk for clinical cardiotoxicity. The data and analytic techniques were accessible through SAS data sets and procedures available to the study at the Pediatric Oncology Group (POG) Statistical Office.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Acupuncture With Manual and Electrical Stimulation to Reduce Labour Pain

The purpose of this study is to evaluate the effect of manual acupuncture and electro-acupuncture on labour pain.

Acupuncture is used in obstetric care in spite of insufficient evidence of its potential to reduce labour pain. The findings so far are contradictory, which may reflect methodological limitations. The present study will take issues into account, such as sufficiently large sample to allow detection of possible differences between study groups; optimal timing of the intervention; controlling for intensity of the treatment; qualified training of persons giving the treatment; biological markers of pain and stress; possible effects on mother and infant; women's experiences such as overall birth experience and memory of pain.

Eligibility Criteria:
Inclusion Criteria:

* Admission to the labour ward in spontaneous onset of labour
* Latent or active phase of labour
* Nulliparity
* Singleton pregnancy, cephalic presentation
* Gestation: 37+0 to 41+6 (weeks + days)
* Expressed need for labour pain relief
* Swedish speaking (well enough to understand written and oral instructions)

Exclusion Criteria:

* No pharmacological pain relief within 24 hours prior to inclusion into the study
* Severe preeclampsia
* Treatment with oxytocin at the time point of allocation
* Treatment with anticoagulant
* Pacemaker
A Window of Opportunity Trial of Mirdametinib Plus Vorinostat for NF1 Associated, H3K27 Trimethylation Deficient Malignant Peripheral Nerve Sheath Tumor [MPNST]

This is a single center Phase 0 "window of opportunity" trial for the treatment of newly diagnosed, PRC2 deficient, primary malignant peripheral nerve sheath tumors (MPNSTs) with a short course of the combination of mirdametinib and vorinostat prior to the most appropriate standard of care treatment for their specific tumor (typically localized radiation followed by surgical resection). Four to eight patients, 12 years of age or older and meeting the study's biomarker inclusion criteria, would be enrolled onto this trial. After voluntary written consent (assent with parent consent for minors) the patient undergoes MRI and PET imaging of the tumor and a needle biopsy to collect tumor is performed. Patients with histone H3K27 trimethylation deficient MPNST, as confirmed by immunohistochemistry, receive a single 28-day course of mirdametinib and vorinostat at standard oral dosing for each. At day 26, 27, or 28 the patient returns to clinic for a research visit repeating the baseline MRI and PET imaging and the needle biopsy for tumor tissue.

This ends direct study participation. The patient goes on to the most appropriate standard of care treatment for their MPNST. Information about the subsequent standard of care treatment is collected for the purposes of this study.


Eligibility Criteria:
Inclusion Criteria:

* Known Neurofibromatosis type 1 (NF-1) syndrome based on current diagnostic criteria.
* Diagnosis of suspected MPNST by PET or MRI imaging
* Confirmation of histone H3 lysine 27 trimethylation-negative MPSNT by immunohistochemistry
* Twelve years of age or older
* Complete blood count (CBC), platelet, liver and kidney function within institutional normal limits performed within 14 days of 1 st dose of study drug.
* Must be able to swallow capsules.
* Females of childbearing potential must use highly effective contraception (see inclusion criteria section) from the time of study enrollment through 6 months after the last dose of vorinostat and mirdametinib. Males with partners of childbearing potential must use highly effective contraception from the time of study enrollment through 3 months after the last dose of vorinostat.
* Provides voluntary written consent prior to any study related activities, with parental/guardian consent and assent for those 12 to 17 years of age at enrollment.

Exclusion Criteria:

* Pregnant or breastfeeding - females of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to the 1 st dose of the study drugs.
* Significant cardiac disease
* Significant eye disease
* Radiation therapy or chemotherapy in the past year.
The Clinical and Economic Impact of Pharmacogenomic Testing of Warfarin Therapy in Typical Community Practice Settings

The purpose of this quasi-experiment study, which could also be classified as a prospective observational intervention study, is to assess the impact of cytochrome P450 2C9 (CYP 2C9) and vitamin K epoxide reductase complex, subunit 1 (VKORC1) testing within a primary patient care setting.

Anticoagulation therapy with warfarin is the most common mode of treatment and prophylaxis for venous and arterial thromboembolic conditions. Warfarin is metabolized in the liver by the cytochrome P450 system, the cytochrome P450 2C9 (CYP 2C9) isoenzyme specifically, and polymorphisms in the CYP 2C9 gene have been associated with changes in metabolic function of the translated isoenzyme . These polymorphisms result in reduced metabolism of warfarin as compared to subjects having the wild type gene, consequently leading to systemic accumulation of warfarin; it is theorized that this leads to higher risk of adverse events. Other allelic variations have also been linked to changes in vitamin K conservation through their effects on vitamin K epoxide reductase complex, subunit 1 (VKORC1) . The combined impact of CYP 2C9 and VKORC1 polymorphisms on warfarin's pharmacology have recently been reported.

It is hypothesized that evaluation of genomic allelic type guided warfarin dosing will reduce thromboembolic and bleeding risks associated with warfarin therapy, and that adoption of a genetic testing strategy in a primary patient care setting would improve warfarin effectiveness and patient safety, and reduce costs to health care payers.

Eligibility Criteria:
Inclusion Criteria:

* Female and male age range of 40-75
* Patients who are in the induction phase of warfarin
* Patients receiving warfarin to prevent or treat thromboembolic conditions (e.g., post orthopedic surgery prophylaxis, deep venous thrombosis, atrial fibrillation, pulmonary embolism, heart failure)
* Patient willing to provide informed consent prior to the specimen collection procedure
* Patient whose physician is willing to order the genetic test

Exclusion Criteria:

* Age \< 40 or \> 75
* Previous use of warfarin within 180 days of initiating new warfarin therapy
* Hospitalized for seven or more days before first claim for warfarin
* Previous history of genetic testing for warfarin therapy
* Known hypersensitivity to warfarin
* Patient or physician refusal to participate in the study
* Patients using warfarin residing in Olmsted County, MN
A Retrospective Analysis of Neevo®/Neevo®DHA Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy

This study is a multi-site, retrospective chart review to determine the effect of Neevo® or Neevo®DHA (with higher folate and B12) versus standard prenatal vitamins on hemoglobin (Hgb) levels in pregnant women throughout the course of pregnancy. Neevo® is a prescription medical food indicated for the dietary management of women under a doctor's care who face high risk pregnancies, older overactive bladder (OB) patients and patients unable to fully metabolize folic acid. Data will be collected from existing patient charts of subjects administered Neevo® or Neevo®DHA daily compared to subjects administered a prenatal vitamin daily.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant females, age 21-39, who received either Neevo®/Neevo®DHA or another standard prenatal vitamin (Prenatal vitamins must contain ≤1 mg folic acid, 27-35mg iron, and ≤12mcg vitamin B12).
* Clinical diagnosis of pregnancy must have been made at ≤12 weeks of pregnancy and on or after January 1, 2008 and delivery must have occurred on or before December 31, 2009.
* Subjects must have been compliant in taking Neevo DHA or other prenatal vitamin.

Exclusion Criteria:

* Subjects should not have taken Prenate®, Prenate®DHA, or Prenate® Elite, which are L-methylfolate-containing prenatal vitamins.
* The following supplements within 2 months prior to randomization; 100mg vitamin C, B12 injection \>10mg of B6; \>32mg Iron; \>1.2mg of folate; an L- methylfolate product that is not a prenatal vitamin such as Life Extension methylfolate, Prothera methylfolate, Thorne 5-MTHF, Metanx®, Neevo®, Neevo®DHA, Deplin®, Cerefolin®, or CerefolinNAC®.
* History of any anemia other than iron deficiency anemia or leukemia.
* Blood transfusion in the 4 months prior to diagnosis of pregnancy.
The Effects of Lateralized Thermal Sleepwear on Sleep, Skin Temperature and Skin Moisture in Menopausal Women

A home-based, sham-controlled, double-blind, crossover study evaluating the effects of wearing sleepwear with lateralized thermal characteristics on subjective and objective sleep measures, proximal skin temperature, and sternal skin moisture in menopausal women complaining of sleep disturbance and vasomotor symptoms.

Sixteen menopausal women who have given informed consent to participate will be medically screened to rule out physiological sleep disorders. Sleep schedules will be regulated to the average bedtime of a two-week baseline sleep log. Subjects will undergo two two-night, home-based monitoring phases, one an experimental and one a control condition, separated by a washout period of at least five nights. The order of conditions will be counterbalanced between subjects in double-blind fashion. In the experimental condition subjects will wear sleepwear constructed of two fabric types arranged bilaterally, with typical cotton spandex insulating material on one side and specialized conductive material on the other. In the control condition subjects will wear sleepwear that is similarly lateralized in terms of appearance but constructed with typical cotton spandex insulating material on both sides. Ambulatory monitoring will include body position, EEG, actigraphy, skin temperature at multiple proximal sites, and sternal skin moisture. Subjective scales of insomnia severity, menopausal symptoms and sleepwear rating will also be employed.

Eligibility Criteria:
Inclusion Criteria:

* At least 12 months since last menstrual period
* Subjective complaint of sleep disturbance, confirmed by Pittsburgh Sleep Quality Index score greater than 5
* Subjective complaint of at least moderate symptoms of menopause, confirmed by modified Kupperman score greater than 15
* Ability to sleep in the left lateral, right lateral and supine positions

Exclusion Criteria:

* Unable to taper off, with health care provider's agreement, hypnotic or sedative medications, hormone replacement therapy, clonidine, gabapentin, or isoflavones and other botanical compounds used to treat vasomotor symptoms of menopause
* Unable to taper to two or fewer caffeinated beverages per day
* Unable to taper to one or fewer alcoholic beverages per day
* Unable to taper off nicotine in any form
* Unable to taper off recreational drugs
* Subjective sleep, based on two-week sleep logs, averaging less than 4.0 or greater than 7.5 hours per night
* Clinical suspicion of obstructive sleep apnea, periodic leg movements or other significant physiological sleep disturbance
* Known skin allergy to silver, cotton, nylon, surgical tape and other adhesives
Effects of Casein Timing on Body Composition and Performance

This study will investigate the effects of night time versus day time casein supplementation on body composition and athletic performance. Participants will consume the protein supplements daily while participating in a supervised, periodized resistance training program.

In a randomized, double-blind, placebo-, exercise- and diet-controlled design, 60 subjects will participate in a 10-week study to determine the influence of selective protein timing on body composition, metabolic, and performance adaptations to resistance training. Diets will be individually standardized using the Cunningham equation adjusted for activity level to determine total maintenance calories. Carbohydrates, fats, and proteins will represent 50, 25, and 25 percent of the determined total calories. Diet counseling will occur weekly until stabilized and biweekly thereafter to ensure compliance with food and fluid intake. Protein will be distributed throughout the day as \>0.30g/kg bw/meal for breakfast, lunch, and dinner. Resistance training sessions will be supervised by research staff and occur 4 times per week and begin between 7 am and 5pm. Exercises will consist of single- and multi-joint exercises for all major muscle groups (legs, chest, back, shoulders, core, and arms), be performed for 3-5 sets of 1-20 repetitions with 1-5 minutes rest between sets, and each muscle group will undergo 72-96 hours rest between training sessions within the periodized program. Protein supplements. In the treatment group, the casein supplement (40g calcium caseinate dissolved in water) will be consumed as the last meal (\>2h following previous meal) before bed and the placebo (40g maltodextrin dissolved in water) either before resistance training, if training after 10am, or after resistance training, if before 10am. The control group will alternate consumption times of the casein supplement and placebo. The supplement (treatment group) or placebo (control group) will not be consumed within 3 hours of beginning or ending resistance training, nor will it be consumed within 3 hours of the first meal following waking. All groups will be provided with 0.30g/kg bw whey protein isolate immediately following training to facilitate recovery. Supplements will be consumed at a similar time of day on non-training days.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* trained (exercises 2-5 days per week for previous 1-3 years)
* maintains regular sleep patterns (7-9 hours per night weekly average)

Exclusion Criteria:

* use of ergogenic aids or medicines known to influence outcomes
* data will be excluded if a participant is \<80% compliant with diet and training interventions
* consumes greater than or equal to 12 alcoholic beverages per week
* tobacco use
* dairy allergy
Time to Excretion of Contrast, a Maastricht Prospective Observational Study

Risk of contrast-induced kidney injury is expected to be strongly correlated with exposure time. Studies on the excretion of iodinated contrast material are few and have mostly been carried out in patients with normal renal function. Although case wise reports of persistent renograms have been published, it is not known how long contrast is retained before excretion in patients with eGFR \<30 mL/min/1.73m2, nor which of these patients are most susceptible to contrast retention. The current observational study aims to compare contrast elimination time and % contrast excretion in patients with eGFR \<30 mL/min/1.73m2, to matched patients (for age, sex and contrast procedure type) with eGFR 30-59 and eGFR \>=60 mL/min/1.73m2.

The primary aim of the current study is to determine contrast elimination time and % in three groups of patients, (with severely reduced, moderate, and mildly reduced to normal renal function). Secondary aims are to explore whether specific situations/characteristics result in higher probability of delayed elimination of contrast, and whether there is a link between elimination time and adverse post-contrast outcomes (post-contrast incidences of acute kidney injury; post-contrast changes in eGFR within 5 days from baseline; 1-month post-contrast change in eGFR; 1-month post-contrast incidences of eGFR decline \>=5 mL/min/1.73m2; 1-month dialysis and mortality).

Eligibility Criteria:
Inclusion Criteria:

- eGFR \<30 mL/min/1.73m2 in absence of dialysis referred for an elective procedure with intravascular administration of iodinated contrast material at Maastricht UMC+

For each included patient with eGFR \<30 mL/min/1.73m2, two matched patients will be included:

* 1. eGFR 30-59 mL/min/1.73m2 referred for an elective procedure with intravascular administration of iodinated contrast material at Maastricht UMC+ with age, sex and contrast procedure type matching the age, sex and contrast procedure type of an eGFR \<30 mL/min/1.73m2 participant.
* 2. eGFR \>=60 mL/min/1.73m2 referred for an elective procedure with intravascular administration of iodinated contrast material at Maastricht UMC+ with age, sex and contrast procedure type matching the age, sex and contrast procedure type of an eGFR \<30 mL/min/1.73m2 participant.

Exclusion Criteria:

* age \<18 years
* dialysis or pre-dialysis
* intravascular contrast administration having occurred \<30 days before the first baseline sample
* emergency or intensive care status.
Preoperative Assessment of Difficult Laryngoscopy Using Different Videolaryngoscopes

preoperative assessment of difficult airways are the subject of debate. Now, measuring the thyromental distance or evaluating the mallampati score, mandible protrusion or body mass index still not 100% specifically say anything. We compare 4 different video laryngoscopes for preoperative assessment of difficult laryngoscopy.

preoperative assessment of difficult airways are the subject of debate. Now, measuring the thyromental distance or evaluating the mallampati score, mandible protrusion or body mass index still not 100% specifically say anything. all patients were pre oxygenated with 100% oxygen with nasal canulla during the whole procedure. We administered 0.07 mgr/kg remifentanil for minimum 3 minutes and continue this infusion during the procedure. The patients airway topicalized by 10% lidocaine spray. We enroll 20 patients undergoing elective surgery.

We compare 4 different video laryngoscopes for preoperative assessment of difficult laryngoscopy in the same patient. We evaluate the patient and the instructors satisfaction with the visual analogy scale and the visualization time. Demographic vary,ables and the airway characteristics of patients. We assess the cormack lehane view of these videolaryngoscopes with or without cricoid pressure. and the occurrence of gag reflex as well.

Eligibility Criteria:
Inclusion Criteria:- \> 18 years or \<60 years of age,

* body mass index \< 30
* no difficult airway history or predictor,
* no respiratory tract infections for ten days,

Exclusion Criteria: BMI \> 35, \< 18 or \> 60 years of age, expected difficult airway, pregnant

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Suspected Cases of Carbon Monoxide Poisoning

The purpose of this study is to collect non-invasive opportunity sample data in suspected or known cases of carbon monoxide poisoning.


Eligibility Criteria:
Inclusion Criteria:

* Known or suspected carbon monoxide poisoning.

Exclusion Criteria:

* Less than 18 years of age
The Blueberry Study

This is a research study about the effects of blueberries on the health of children who do not eat much fruits and vegetables. By doing this study, we hope to find out what nutrients from blueberries appear in the blood and urine of the child

This is a double blinded randomized control trial aiming to characterize the profile of polyphenol-derived metabolites in plasma and urine for children ages 11-12 years supplemented short term with wild blueberry powder. The study will assess if a short-term supplementation (5 days) with wild blueberry powder impacts immune responses as well as markers for cardiovascular and bone health. Up to 44 children will be recruited. The participants will attend three visits at Arkansas Children's Nutrition Center.

Eligibility Criteria:
Inclusion Criteria:

* Eats \<1.5 cup of fruit and \<2.0 cup of vegetables per day
* Boys or girls
* All ethnicities
* All BMIs

Exclusion Criteria:

* Known allergy to blueberries
* Epilepsy
* Asthma
* Chronic kidney disease
* Hormonal disease
* Autoimmune disease
* Bleeding disorders
* Chronic infections
* Type 2 and Type 1 diabetes mellitus
* Attention deficit hyperactivity disorder
* Opposition defiant disorder
* Autistic spectrum disorder
* Pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest
* If the participants/parents perceive barriers with adhering to low-polyphenol meals
* Parent or child refusal to stop nutritional supplements
* Parent or child refusal to have blood drawn