cyrilzakka/clinical-trials huggingface dataset:
Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia.

Chronic cervicobrachialgia is a public health problem. Epidural injections of corticosteroids and local anesthesics via transforaminal and interlaminar routes both have shown their potential in its treatment. The interlaminar approach offers the advantage of an epidural injection (i.e., direct contact with the nerve root in the epidural space). However, it requires fluoroscopy and can lead to potentially serious complications (compression of the nerve root, spinal cord injury...). The ultrasound-guided injection of corticosteroids via the transforaminal route, which offers the advantage of selectively targeting the symptomatic nerve root, may have the same therapeutic advantages as the interlaminar approach in decreasing unilateral cervicobrachial pain (i.e. a decrease in pain after infiltration) and reduce its risks.The aim of this study is to compare the efficacy of transforaminal vs interlaminar cervical corticosteroid injection.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status (ASA) I-III
* Chronic unilateral cervicobrachial pain
* Allowed Steroid infiltration

Exclusion Criteria:

* Pregnancy
* Lactation
* Allergy or intolerance to any of the drugs/materials used in this study,
* Participation in another interventional study
* Systemic anticoagulation,
* Infection at the puncture site
* Patient refusal.
Study to Evaluate the PK of PO Omadacycline in Adults With Community-Acquired Bacterial Pneumonia

The purpose of this study is to evaluate the pharmacokinetics of an oral omadacycline dosing regimen in the treatment of adults with CABP.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants, age 18 or older who have signed the informed consent form
* Must have a qualifying community-acquired bacterial pneumonia
* Has disease severity such that oral antibiotics therapy is appropriate
* Participants must not be pregnant at the time of enrollment
* Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug
* Must be able to swallow tablets and comply with all of the requirements of the study

Exclusion Criteria:

* Has received more than 24 hours of a potentially effective systemic antibacterial therapy within the 72 hours prior to the first dose of test article
* Known or suspected infection caused by a pathogen that may be resistant to test article
* Participants who reside in a long-term care or nursing home
* Evidence of empyema
* Evidence of significant immunological disease
* Evidence of liver impairment or disease
* Evidence of unstable cardiac disease
* Severe renal disease or requirement for dialysis
* Evidence of septic shock
* Has a history of hypersensitivity or allergic reaction to any tetracycline
* Has received an investigational drug within the past 30 days
* Participants who are pregnant or nursing
* Unable or unwilling to comply with the protocol requirements
Dose Estimation for Studies of Acute Respiratory Effects

To modify and expand an existing pharmacokinetic model for nasal dose as well as to develop a new model to estimate tracheobronchial dose of an active agent for each subject in a study of acute respiratory health effects.

BACKGROUND:

Epidemiologic analysis of acute, reversible respiratory health effects is uncommonly performed, yet these are important health outcomes because acute responses by the respiratory defense system appear to represent one end of the continuum toward progressive, chronic and potentially disabling physiologic changes. Repeatable epidemiologic studies of dose-response relationships necessitate accurate measures of 'dose'. However, in occupational and environmental settings, exposure to a toxin is seldom found at identical concentrations and/or particle sizes among persons with the same activity patterns. In addition, air concentration does not account for factors such as clearance or metabolism which may alter the biologically effective tissue dose. These factors cause the target tissue dose of the toxin to vary greatly despite exposure to similar air concentrations.

DESIGN NARRATIVE:

The results of these toxicokinetic models were individual measures of tissue dose used in a 2-stage epidemiologic analysis which placed special emphasis on the definition of individual dose-response curves for exposure to an irritant dust, sodium borate, and the reversible effects of peak expiratory flow and irritant symptoms. A primary advantage of the two stage epidemiologic approach was that it permitted particular attention to be focused on the factors which determined the sensitivity (threshold) and reactivity (slope) for an individual. The use of tissue dose estimates were also compared to simple exposure measurements in the epidemiologic analysis to evaluate the efficacy of using dosimetric methods in epidemiologic studies.

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
Using "Decision Aids" to Help the Infant Family to Decide the Use of Oral Rotavirus Vaccine

Using decision aids (DA) is one way to provide information to infant family and to involve them in making decisions about their baby's vaccination. We developed a DA administered after consultation for baby's family deciding on whether the baby will receive the self-paid oral rotavirus vaccine

Background:

Acute gastroenteritis is one of the most common infectious diseases and still a major cause of pediatric morbidity and mortality worldwide. Rotavirus was still the major cause of acute gastroenteritis in infants and young children worldwide, including in Taiwan. The World Health Organization has recommended rotavirus vaccine, which became available in 2006, for all countries. However, not all of children in Taiwan received rotavirus vaccination. Using decision aids (DA) is one way to provide information to infant family and to involve them in making decisions about their baby's vaccination. We developed a DA administered after consultation for baby's family deciding on whether the baby will receive the self-paid oral rotavirus vaccine Patients and Methods Decision aids are interventions designed to help infant family make choices among options by providing information relevant to oral rotavirus vaccine. Infant coming to receiving regular routine vaccination at 1 month old are randomly assigned to receive a DA or the standard oral conversation (control condition) after the initial consultation. Infant family complete interview-based questionnaires 1 month later when they came back to hospital receiving 2-month-old regular routine vaccination and decide to receive self-paid oral rotavirus vaccine or not at that time. Primary outcome measures: decisional conflict and decision-making difficulties at 2-month-old.

Results and Conclusion The DA group are predicted to lower decisional conflict scores when compared with the control group. Our study hopes to support the efficacy of DA in helping the infant family to decide whether the baby will receive the self-paid oral rotavirus vaccine.

Eligibility Criteria:
Inclusion Criteria:

The one-month-old baby's family whose age is between 20 and 80 years old.

Exclusion Criteria:

1. . The doctor determines that the baby's family is not suitable; if baby's family cannot understand Chinese languages what we said.
2. . The participants' baby who have fever or contraindication for oral rotavirus.
Continuous Hemoglobin Monitoring: Detection of Acute Blood Loss - Accurate, Timely and Cost-effective

The purpose of the study is to determine whether noninvasive hemoglobin monitoring is sensitive and accurate enough to detect a significant downward trend in hemoglobin in patients at risk for significant bleeding. If this can be shown, it has the potential to spare patients multiple invasive blood draws as well as allow for earlier detection of significant blood loss and therefore positively impact on patient morbidity and mortality. Additionally, it may represent significant financial cost savings in that it may allow for patients to be monitored in a non-intensive care unit setting.

This will be an observational study. The continuous hemoglobin monitor will be connected to the patient and hemoglobin measurement data will be collected. Routine laboratory hemoglobin monitoring will occur concurrently at a pre-specified frequency as well as at the physician's discretion based on usual clinical information. The physician will be blinded to the continuous hemoglobin monitoring readings and therefore patient care will not be affected by the use of the monitor. Once the study has ended, the data will then be analyzed to assess for correlation between continuous hemoglobin monitoring readings and laboratory hemoglobin measurement.

No recruitment initiated

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* admission to surgical intensive care unit
* suspected or high risk for ongoing blood loss

Exclusion Criteria:

-
Pericapsular Nerve Group Block Versus Fascia Iliaca Block for Pediatric Hip Surgery

This compares the postoperative analgesic effect of ultrasound-guided pericapsular nerve group block (PENG) with ultrasound-guided fascia iliaca compartment block in pediatric patients undergoing hip surgery.

Surgeries involving hip joints in pediatric patients are associated with severe intraoperative and postoperative pain despite the use of systemic opioids.

Caudal block is the most commonly used method of regional anesthesia in children to control intraoperative and postoperative pain in surgeries involving lower limbs. However, there have been many side effects of caudal block such as hypotension, urine retention, excessive motor block, technical failure, nausea, and vomiting which may limit its use.

There are several techniques of ultrasound-guided regional anesthesia that are used to control acute pain in hip surgery with fewer side effects such as a lumbar plexus block, femoral nerve block, or a fascia iliaca compartment block.

The fascia iliaca compartment block (FICB) was described in 1989. It remains a popular regional anesthetic technique for surgical procedures involving the hip joint and femur. Local anesthetic (LA) is injected proximally beneath the fascia iliaca to block the femoral nerve (FN), obturator nerve (ON), and lateral cutaneous nerve of the thigh (LCNT) simultaneously.

The pericapsular nerve group (PENG) block was introduced to block the articular branches of the femoral, obturator, and accessory obturator nerves which provide sensory innervation to the hip. This regional anesthetic technique was described in 2018 for acute analgesia related to hip fractures.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients
* aged 1-6 years old
* both sexes,
* American Society of Anesthesiologists (ASA) physical activity class I-II
* scheduled for elective hip surgery under general anesthesia.

Exclusion Criteria:

* Children with the severe systemic disease with American Society of Anesthesiologists physical activity class III or IV.
* Children with previous neurological or spinal disorders.
* Coagulation disorder.
* Infection at the block injection site.
* History of allergy to local anesthetics.
The Drinking Dashboard Study

This study aims to develop and pilot test the efficacy of a "Drinking Dashboard" providing participants weekly feedback on the risk factors and consequences of blackout.

Approximately 50% of young adults who drink alcohol experience alcohol-induced "blackouts," defined as permanent (en bloc) or temporary (fragmentary) memory loss for events that occurred while they are drinking. This experience of alcohol-induced blackout is associated prospectively with alcohol-related harm, including emergency room visits and sexual coercion, with medical care costs exceeding $469,000 per year. While young adults who have recently experienced a blackout report less favorable evaluations of drinking events and increased motivation to decrease their drinking, they do not actually change their drinking behavior as a result of the blackout alone. Collectively, these data suggest that blackouts may serve as an opportunity for intervention, after which young adults are more likely to respond to alcohol feedback. This R34 aims to develop an intervention tailored to individuals who experience blackouts. In the trial phase, 162 young adults (50% female, ≥50% non-college) who report a history of blackout will be randomly assigned to receive the intervention (n=81) or assessment only (n=81). Outcomes will be assessed immediately post-intervention and at 3-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* 18-30 years of age
* Binge drinking in a typical week
* Any form of alcohol-induced memory impairment in the past month at baseline

Exclusion Criteria:

* Psychiatric disorder requiring immediate clinical attention (e.g., psychosis, suicidal ideation with intent and plan)
Study of Quality of Life in Older vs. Younger Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Myelodysplastic Syndromes

This is a multi-center, Phase II, cross-sectional study comparing quality of life (QOL) as assessed by patient-reported outcomes (PROs) in older (≥65 years) adults vs younger (55-64 years) undergoing allogeneic hematopoietic cell transplantation (HCT) for myelodysplastic syndromes (MDS).

Transplant recipients who have met the inclusion and exclusion criteria and from participating study sites will be asked to complete an online consent and survey for the study. This survey is the patient-reported outcomes survey and will be used to assess quality of life. The survey results will then be compared by age group and by time post transplant, between 6 months and a year post transplant, 1 year to 3 years post transplant, and 3 years or more post transplant.

Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate on this study, an individual must meet all of the following criteria:

1. Underwent an allogeneic HCT for MDS on the 10-CMSMDS-1 protocol
2. Prior consent to research and future contact by the CIBMTR
3. Ability to provide RCI BMT protocol 17-ePRO signed and dated informed consent form (ICF)
4. Age ≥55 years at time of transplant
5. Fluent in English or Spanish
6. Greater than 6 months post-HCT

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation on this study.

1. No access to an internet browser or email account
2. Within 6 months of first HCT for MDS on the 10-CMSMDS-1 protocol
A Multi Center Study Comparing the Efficacy of CAD EYE and the Standard of Care (White Light )

This study is to assess the sensitivity and added benefits of CADEYE compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.

Failure in polyp recognition is a major determinant for the high rate of missed colorectal neoplasms. In response, technological advances have paved the way for Computer-Aided Polyp Detection (CAD-e) systems. Artificial intelligence systems allow of real-time computer- aided detection of polyps with high-accuracy. CADEYE is a CAD-e system (FUJIFILM) that enables real-time video processing at the same rate as the standard procedure.

The data generated from this study will provide an estimate of the ADR throughout the Middle East as well as assess the accuracy of CADEYE in detecting adenomas in comparison to standard of care.

Eligibility Criteria:
Inclusion Criteria:

* 40-80 years old subjects
* Subjects undergoing colonoscopy for the following: o Primary CRC screening

  * Post-polypectomy surveillance
  * Work up following FIT positivity
  * Symptoms/signs suspicions of CRC
* Subjects must be willing to give written informed consent for the trial

Exclusion Criteria:

* Unable to consent
* Contraindicated to undergo endoscopy
* Hospitalized patient
* Patients with the following conditions:

  * History of colon resection
  * History of CRC
  * Antithrombotic therapy precluding colon resection o Inflammatory Bowel Disease (IBD)
  * Familial Adenomatous Polyposis (FAP)
* Pregnant or lactating
* Poor bowel preparation: BBPS 0 or 1 in a segment
A Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI)

Circadian rest-activity rhythm disorders are common in patients with cancer, particularly in advanced disease. A recent international e-Delphi study has outlined recommendations for the assessment and reporting of the disorder and subsequently an observation study is underway assessing a cohort of patients with advanced cancer. Affected patients are eligible to enter a feasibility study assessing a non-pharmacological multi-modal intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old
2. Outpatient
3. Diagnosis of advanced cancer (locally advanced, incurable, metastatic)
4. Ambulatory
5. Estimated prognosis ≥ 3 months
6. Evidence of a circadian rest-activity rhythm disorder

Exclusion Criteria:

1. Inpatient
2. Engaged in shift-work
3. Long-haul travel in the last 14 days
4. Physical impairment limiting movement of the non-dominant arm
5. Cognitive impairment limiting the ability to complete the assessment tool and/or patient diary
6. Uncontrolled high blood pressure or tachycardia
7. Exercise-related symptoms and signs (e.g. chest pain, syncope, limb claudication, hypoxia at rest)
8. Participant has a history of uncontrolled mania or bipolar disorder
9. Participant has a recent history or current thoughts of self-harm or suicide
10. Participant has a recent change in antidepressant medication
11. Participant has an eye disorder (e.g. glaucoma, cataracts, retinopathy)
Accuracy Characterization Study

To demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring System (System) interstitial glucose results against venous glucose reference and capillary fingerstick using the Consensus Error Grid over the wear duration. During the course of the wear duration, the subject is required to be testing fingerstick glucose measurement at least 8 times a day for capillary reference glucose measurements and three in-clinic visits of maximum 10 hours each for venous reference glucose measurements. With every reference measurement, the subject or study staff will perform a measurement on the System.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must be at least 18 years of age.
2. Subject must have type 1 or type 2 diabetes for at least 2 years prior to enrollment.
3. Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily) for at least 6 months prior to enrollment.
4. Subject must be able to read and understand English.
5. In the Investigator's opinion, the Subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
6. Subject must be available to participate in all study visits up to a period of 14 days.
7. Subject must be willing and able to provide written signed and dated informed consent.

Exclusion Criteria:

1. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
2. Subject is pregnant, attempting to conceive or not willing and able to practice birth control during the study duration.
3. Subject has skin lesions, scarring, redness, infection or edema at the application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
4. Subject currently is participating in another clinical trial.
5. Subject has donated blood within 112 days prior to the beginning of the study activities.
6. Subject has concomitant medical condition which, in the opinion of the Investigator, could interfere with the study or present a risk to the safety or welfare of the Subject or study staff. Such conditions include but are not limited to:

   * History of HIV, Hepatitis B or C, or other blood-borne pathogen;
   * Subject has an increased risk of bleeding.
   * Subject has X-ray, MRI or CT appointment scheduled during the period of study participation, and the appointment cannot be rescheduled for a time before study participation starts or after study participation ends.
   * Subject is unsuitable for participation due to any other cause as determined by the Investigator.
Isolated Pancreatic Loop With Modified Pancreaticojejunostomy

The aim of the present study was to observe whether the modified pancreatico- jejunostomy (PJ ) technique with an isolated pancreatic loop would effectively reduce the POPF rate and overall morbidity after PD

Postoperative pancreatic fistula (POPF) is widely regarded as the most threatening complication following pancreaticoduodenectomy (PD). Its clinical impact and sequelae have been previously described and shown to contribute to the development of other morbid complications and high rates of mortality.

The aim of the present study was to observe whether the modified pancreatico- jejunostomy (PJ ) technique with an isolated pancreatic loop would effectively reduce the POPF rate and overall morbidity after PD.

Methods: We report our early experience using a modified PJ technique with an isolated pancreatic loop after after PD in 201 patients between January 2010 and December 2020.

Eligibility Criteria:
Inclusion Criteria:

* age up to 30
* head of the pancreas tumor

Exclusion Criteria:

* body and tail pancreatic tumors
Growth of Healthy Term Infants Fed a Partially Hydrolyzed Follow-up Formula

Growth of healthy term formula-fed infants who receive a single feeding regimen consisting of an existing partially hydrolyzed starter formula, then subsequently fed a partially hydrolyzed follow-up formula over the first year of life.


Eligibility Criteria:
Inclusion criteria:

1. Having obtained his/her parents' (or his/her legally accepted representative's \[LAR's\]) written informed consent and having evidence of personally signed and dated informed consent document indicating that the infant's parents/LAR have been informed of all pertinent aspects of the study.
2. Age ≤ 14 days after birth (date of birth = Day 0).
3. Full-term gestational birth (≥ 37 and ≤ 42 weeks).
4. Weight at birth ≥ 2500 g and ≤ 4200 g
5. Born to mothers with (normal) pre-pregnancy BMI ≥ 18.5 to \< 26 kg/m2.
6. For formula-fed infants: born to mothers who independently elected, before study enrollment, not to breastfeed, but having received any HM is permitted (not applicable for infants in the HM-fed group)
7. For HM-fed infants: mothers intend to provide breast milk until age 6 months
8. Infant's parent(s)/LAR is of legal age of consent, has sufficient command of the French language to complete the informed consent and other study documents, and is willing and able to fulfill the requirements of the study protocol.
9. Infant's parent(s)/LAR is able to be contacted directly by telephone throughout the study.

Exclusion criteria:

1. Born to mothers with hormonal or metabolic disease (e.g. Type-1, Type-2, or gestational diabetes diagnosed according to standardized criteria).
2. Born to mothers who smoked \> 10 cigarettes per day during pregnancy.
3. Born to mothers who used illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (\> 3 alcoholic beverages per week) during pregnancy.
4. Cognitive or physical developmental disorders (e.g., malabsorptive disorders such as short bowel syndrome; neurological and congenital disorders that may delay growth such as cerebral palsy, agenesis of the corpus callosum, spina bifida, Down syndrome, Cri Du Chat; disorders that may lead to obesity such as Prader Willi syndrome, Angelman syndrome; other renal, hepatic, pancreatic, or cardiovascular disorders).
5. Participation in any other clinical trial prior to enrollment.
6. Infants or infant's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures.