cyrilzakka/clinical-trials huggingface dataset:
Delirium Assessment in the Pediatric Intensive Care Unit

The aim of this study was to show the efficacy of non-pharmacological interventions on preventing pediatric delirium in pediatric intensive care unit

The aim of this study was to show the efficacy of non-pharmacological interventions on preventing pediatric delirium in pediatric intensive care unit. Patients who is followed up for at least 48 hours in pediatric intensive care unit will be included in the study. Parents of patients will be allowed to stay with the patient as long as the conditions of service is appropriate. Parents will provide oral treatments to the patients. Patients will be allowed to spend time with their phone, tablet or toy in accordance with their age. Fellow resident will screen for pediatric delirium each child using the Cornell Assessment of Pediatric Delirium twice a day.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric Cerebral Performance Category \< 5 points
* Patients who stay in PICU \>48 hours

Exclusion Criteria:

* Pediatric Cerebral Performance Category \> 4 points
* Patients who stay in PICU \<48 hours
Assessments of Diaphragm-pleural Mechanics During the Weaning From Prolonged Mechanical Ventilation

Weaning failure from mechanical ventilator is commonly seen in respiratory failure and increases duration of ventilator use, ICU stay, ventilator associated pneumonia and even mortality. The diaphragm serves as one of the most important respiratory mechanism and its function differs the weaning success rate. Since 1980s, ultrasonography assessment in diaphragm movement were developed and further discussion upon whether it serves as a predicting factor for extubation failure. The measurement includes difference of diaphragm thickness, diaphragm excursion or the movement of liver and spleen.

Multiple studies targeted intubated patients with different measurement methods and all resulted with good weaning prediction value.6 Of all the studies, only one study targeted tracheostomy tube patients. They reported diaphragm thickness fraction \>36% as cutoff value is associated with successful spontaneous breathing trial (SBT), with a sensitivity of 0.82, specificity of 0.88. However, little comparison with traditional weaning parameters was mentioned in the study. We designed this prospective observational study to evaluate whether diaphragm movement under ultrasound serves as a predicting index of ventilator discontinuation in patients with tracheostomy. The diaphragm movement will also correlate with other parameters such as RSBI, Pi max, Pe max, Tv spont., WEANSNOW score(WS), VO2, APACHE II. Esophageal pressure is also provided as an option for our study population for more information such as pleural pressure, transdiaphragm pressure, etc.

The ultrasonography measurement of diaphragm movement will be performed within 6 hours before discontinuation of ventilator. The patient remains in semi-recumbent position with the convex probe selected for its good penetration. The probe is placed at a craniocaudal axis, 90 degrees to the skin at the lower intercostal spaces to right anterior axillary line (AAL) and left posterior axillary line (PAL), which allows a perpendicular ultrasound beam direction to the diaphragm movement. Liver (border or vascular structure), splenic (border or vascular structure) will be selected as target point and the marked distance of movement during quiet respiration cycle will be measured 10 times with a largest value calculated. Other echo measurements will also be attempted.

The study aims to investigate if the measurement of the diaphragm movement serves as a reliable predicting factor for weaning failure in respiratory care center patients.


Eligibility Criteria:
Inclusion Criteria:

* Prolonged mechanical ventilation with tracheostomy tube
* Oxygen with a fraction of ≤ 0.4
* Positive end expiratory pressure at ≤ 5 cm H2O
* Pressure support at ≤ 8 cmH2O

Exclusion Criteria:

* No spontaneous breathing
* Unstable hemodynamic status,
* History of peritonitis, intraabdominal operation, empyema, or pleurodesis.
A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors

This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have an advanced solid tumor that has progressed on standard therapies known to provide clinical benefit or the participants are intolerant to such therapies.
* Participants have adequate bone marrow, renal, hepatic and coagulation function.
* For all dose expansion arms, participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
* Participants in combination therapy cohorts must have an advanced solid tumor where the use of nivolumab is standard therapy.

Exclusion Criteria:

* Active or prior documented autoimmune disease in the last 2 years. Participants with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
* Current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).
* History of primary immunodeficiency, bone marrow transplantation, chronic lymphocytic leukemia, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
* Confirmed positive test results for human immunodeficiency virus (HIV), or participants with chronic or active hepatitis B or C. Participants who have a history of hepatitis B or C who have undetectable HBV DNA or HCV RNA after anti-viral therapy may be enrolled.
* Prior grade greater than or equal to 3 immune-mediated neurotoxicity or pneumonitis (or any other unresolved or symptomatic adverse event in the last 3 months) while receiving immunotherapy.
* Male participants who are considering fathering a child or donating sperm during the study or for at least 3 or 5 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug.
Investigating the Effect of 4-week Omega-3 Polyunsaturated Fatty Acid Supplementation on Inflammation

Investigate the in vivo effects of n-3 PUFA supplementation on inflammation, gene expression and epigenetic signatures.

Ex vivo stimulation of peripheral blood mononuclear cells (PBMCs) collected pre and post n-3 supplementation and measurement of it's effect on inflammation, gene expression and epigenetic signatures.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* Aged between 18 and 30 years

Exclusion Criteria:

* Females (Due to differences in cell membrane incorporation of n-3 PUFAs between the sexes and the testing schedule being unable to fit in with menstrual cycle, therefore altering the blood markers that are being measured).
* Aged below 18 or above 30.
* Body mass index (BMI; in kg/ m2), below 18 or above 30.
* Use of vitamin or fish oil supplements in the last 6 months.
* High habitual oily fish consumption (\<4 servings per month).
* Smoking.
* Changes in weight in the past 6 months (Dieting) or planning on changing dietary habits.
* Habitual use of anti-inflammatory drugs.
* Self-reported history of diabetes.
* History of heart disease, coagulation/bleeding disorders, metabolic disease or Serious allergy.
* Known to have blood-borne virus.
* Receipt of inoculations within 2 months of starting the study or the intention to receive such during the study.
* Donation of or intention to donate blood within 8 weeks of the first sample or at any point during the intervention.
Comparing an Adductor Fatigue Strength Test with Handheld Dynamometry

The strength of the adductor muscles in a population of federated athletes will be measured using two tests: First, the maximum strength test, utilizing handheld dynamometry. Subsequently, endurance strength will be measured with the Adductor Fatigue Test (Brazilian Adductor Performance Test), in order to evaluate a possible correlation between the two tests.

The strength of the adductor muscles in a population of federated athletes will be measured using two tests: First, the maximum strength test, utilizing dynamometry, where the subject will perform a maximal isometric contraction against the resistance provided by the investigator. Subsequently, endurance strength will be measured with the Adductor Fatigue Test (Brazilian Adductor Performance Test), the participant must perform an adductor exercise as many repetitions as possible until exhaution. In order to evaluate a possible correlation between the two tests and thus, by performing one of them, obtain the results of the other variable.

Apart from the strength measurements, democraphic caracteristics will be recorded to assess possible correlations between studied variables.

Eligibility Criteria:
Inclusion Criteria:

* Having an active lifestyle
* Competing at any level in a federated sports discipline.

Exclusion Criteria:

* Not consenting to participate in the research.
* Being unable to understand or write in Spanish.
* Having sustained any type of injury to the inguinal musculature in the past 3 months.
Dietary Sugar Absorptive Phenotype for Prediction of Weight Loss Outcome

This study is trying to determine whether the success of bariatric surgery can be predicted by evaluating the dietary sugar absorptive characteristics in the small intestine and if there is any gene expression change on the dietary sugar absorptive characteristics.


Eligibility Criteria:
Inclusion Criteria:

- Obese patients (BMI ≥ 30) scheduled for BS undergoing standard of care screening EGD, or lean BS-naïve individuals (BMI ≤ 25) subjected to EGD for routine clinical indications as part of standard care.

Exclusion Criteria:

* Adults unable to consent, including non-English speakers.
* Pregnant women because endoscopy is a risk factor. All patients of childbearing age undergo history as well as urine pregnancy test as a standard of care prior to undergoing endoscopy as the procedure is performed under anesthesia.
* Prisoners.
* Subjects with preexisting conditions (e.g., bleeding at the time of the procedure, suspected perforation during the standard-of-care procedure) will be excluded from the study at the time of the endoscopy.
* Have a contraindication to endoscopy.
* A history of surgery on the stomach or small intestine.
* Type 1 diabetes (clinical diagnosis and/or positive glutamic acid decarboxylase antibodies).
* Using weight loss medications.
* Active malignancy within the last 5 years.
Postoperative Intervention Educational Program on the Quality of Life of Patients With Hip Fracture

The objective of this study is to determine the impact of a postoperative educational intervention program on the health-related quality of life (HRQoL) of patients with hip fracture using a controlled clinical trial in a randomized, multicenter study. A total of 224 patients will be recruited, 102 patients from trauma units at the two University Hospitals of the province of Cáceres will receive the educational program, whereas 122 will not. Patients will consecutively included in either an intervention or a control group. Patients from the intervention group reill eceive an educational program during admission and the postoperative period. Patients from the control group will not receive any educational program. These patients will manage according to routine protocols.

This study will be perform by Spanish nurses.

Eligibility Criteria:
Inclusion criteria:

* Patients over 65 years of age
* Diagnosis of hip fracture
* Previous urgent surgical intervention for surgical fixation of the fracture

Exclusion criteria:

* Cognitive impairment
* Terminal situation
The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease

This is a Phase 2, open-label, parallel-group, multiple dose study designed to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple doses of lixivaptan in Autosomal Dominant Polycystic Kidney Disease subjects with chronic kidney disease (CKD) in stages CKD1, CKD2 or CKD3.

Therapeutic interventions aimed at counterbalancing the effect of vasopressin and/or normalizing intracellular levels of cAMP may be effective in delaying disease progression in autosomal dominant polycystic kidney disease (ADPKD).

The primary objectives of this study in subjects with ADPKD are:

* To characterize the safety and tolerability of lixivaptan following multiple doses in ADPKD subjects with relatively preserved kidney function (chronic kidney disease CKD1 and CKD2) and moderately impaired renal function (CKD3).

The secondary objectives of this study are:

* To characterize the PK profile of lixivaptan and its major metabolites following multiple doses of lixivaptan in ADPKD subjects with relatively preserved kidney function (CKD1 and CKD2) and moderately impaired renal function (CKD3).
* To characterize the pharmacodynamic effect of lixivaptan on urine output, urine osmolality, total kidney volume, serum vasopressin, and serum creatinine following multiple doses of lixivaptan in ADPKD subjects with relatively preserved kidney function (CKD1 and CKD2) and moderately impaired renal function (CKD3).

Eligibility Criteria:
Inclusion Criteria:

* Male or female, between 18 and 65 years of age at the time of screening
* Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 with eGFR calculated by the CKD EPI equation
* Diagnosed with ADPKD by modified Ravine criteria
* Considered by Investigator to be in good health relative to underlying CKD status and clinically stable with respect to underlying CKD

Exclusion Criteria:

* Known sensitivity or idiosyncratic reaction to lixivaptan, its related compounds such as benzazepines (e.g., tolvaptan, conivaptan, benazepril, fenoldopam, or mirtazapine), or any compound listed as being present in the study formulation
* Women who are pregnant or breast feeding
* Subjects have taken tolvaptan, oral or intravenous antibiotics, or any investigational drug or used an investigational device within 30 days or 5 half-lives, whichever is longer, prior to first study dose
* Subject has a transplanted kidney, or absence of a kidney
* Subjects with clinically significant incontinence, overactive bladder, or urinary retention (e.g., benign prostatic hyperplasia)
* Subjects with clinically significant liver disease, or clinically significant liver function abnormalities or serology other than that expected for ADPKD with cystic liver disease at baseline
* Subjects with any clinically significant concomitant disease or condition other than ADPKD (including treatment for such conditions) that, in the opinion of the Investigator, could either interfere with the study drug or pose an unacceptable risk to the subject
Evaluating Symptom Management Educational Materials for Patients With Prostate Cancer

RATIONALE: Collecting feedback from patients with prostate cancer may help doctors develop better symptom management educational materials for patients.

PURPOSE: This clinical trial is evaluating symptom management educational materials for patients with prostate cancer.

OBJECTIVES:

* To collect formative evaluation data about a new educational intervention using focus groups of patients with prostate cancer.
* To use the focus group data in the master's research paper of a Baylor College of Medicine physician-assistant student who is documenting the process of organizing and conducting the focus groups, enumerating areas where the new materials are deemed problematic, and identifying themes in the comments made by the focus group participants.

OUTLINE: Study participants are assigned to 1 of 3 focus groups according to educational level and ethnicity (i.e., lower educational-level African-American men primarily from the Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC); lower educational-level Caucasian men from MEDVAMC, Baylor College of Medicine (BCM), or the community; or higher educational-level Caucasian men primarily from BCM or the community).

Participants review written patient educational-intervention materials on prostate cancer and provide feedback to the investigator on the content and acceptability of these materials during a 1½-2-hour focus group discussion. Feedback data are used to revise the intervention materials so that they are appropriate to the target population.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Biopsy-proven prostate cancer

  * Localized disease that has been previously treated
* Selected for participation from 1 of the following:

  * Convenience sample of men from the Baylor College of Medicine (BCM) Urology clinics at Scurlock Tower (including the Urology clinic at MEDVAMC) and local prostate cancer-support groups
  * Prostate cancer survivors who participated in the US TOO Father's Day Walk/Run or the Gay Pride Celebration

PATIENT CHARACTERISTICS:

* Able to speak and read in English
* Willing to review the written patient educational materials and discuss them in a group setting

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Efficacy and Tolerability Study in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients

Efficacy and tolerability study in severe chronic obstructive pulmonary disease (COPD) patients.

Efficacy and tolerability study of Symbicort Turbuhaler (160/4.5µg/inhalation,2inhalations twice daily) added to Atrovent (20µg/inhalation, 2 inhalations 4 times daily) + theophylline SR(0.1g/tablet, 1 tablet p.o. twice daily) compared with Atrovent + theophylline SR in severe COPD patients.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent
* Men or women patients ≥ 40 years of age
* Diagnosis of COPD with symptoms for more than 2 years and there is a history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before Visit 2
* Forced Expiratory Volume in 1 second (FEV1) ≤50% of predicted normal value, pre-bronchodilator and Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) \< 70%, pre-bronchodilator
* Total symptom score of 2 or more per day for at least half of run-in period (breathing, cough and sputum scores from the diary card) and complete morning recordings of Digital Peak Flow Meter data at least 7 out of the last 10 days of the run-in period

Exclusion Criteria:

* A history of asthma and seasonal allergic rhinitis before 40 years of age
* Patients who have experienced exacerbation of COPD requiring hospitalisation and /or emergency room treatment and/or a course of oral steroids and/or intravenous corticosteroids and/or antibiotics within 4 weeks prior to Visit 2 and/or during run-in period
* Patients with relevant cardiovascular disorder judged by the investigator
* Patients with glaucoma, prostatic hyperplasia or bladder-neck obstruction judged by the investigator
* Women who are pregnant, breast-feeding or of child-bearing potential judged by the investigator
R5 Integrase Study in HIV-1 Naive Patients

This is a pilot, open-label study of raltegravir and maraviroc in combination for the treatment of antiretroviral naïve patients. The study will enroll 7 antiretroviral naïve patients with CD4 counts ≥ 350 and viral loads \> 5,000. The subjects will be followed for 48 weeks. The combination of these two agents has the potential to be a potent regimen with minimal metabolic complications. However, they have not been studied in combination previously.

This pilot study proposes to evaluate this combination in antiretroviral naïve patients to document the safety and efficacy of this combination in order to provide clinicians with a treatment regimen that minimizes the risk of metabolic complications.

Seven antiretroviral naïve HIV infected participants will be treated with a combination of raltegravir and maraviroc and followed for 48 weeks to determine the time to virologic suppression of (HIV-1 viral load \< 50 copies/ml).

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection
* CD4 count ≥ 350
* RNA \> 5,000
* CCR5 tropic virus
* Baseline genotype without significant mutations known to confer antiretroviral drug resistance to currently licensed antiretroviral agents
* Antiretroviral naïve (\< 7 days of experience)
* 18-75 years of age
* Subject able to provide informed consent for the study
* Women of child-bearing age agree to remain abstinent or use (or have their partner use) an acceptable method of birth control throughout the study. Acceptable method of birth control is defined as intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy.

Exclusion Criteria:

* Dual/mixed tropic virus,
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 times the upper limits of normal;
* Total bilirubin \>1.5 mg/dL,
* Women pregnant or breastfeeding,
* History of malignancy
* Enrollment in an experimental protocol with concomitant use of drugs known to impact or be impacted in terms of pk or drug-drug interactions with either raltegravir or maraviroc. This includes inducers of UGT1A1 ( such as rifampin, phenytoin, Phenobarbital rifabutin, St. John's wart) as well as CYP3A inhibitors (such as ketoconazole, itraconazole, clarithromycin , nefazodone and telithromycin) and CYP3A inducers (such as rifampin, carbamazepine, Phenobarbital and phenytoin)
* Enrollment in an experimental protocol having received investigational agents(antiretroviral or non-antiretroviral) within 30 days of study enrollment
* Chronic active hepatitis B infection
* Subject has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient to participate.
* Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
* Subject requires or is anticipated to require any of the prohibited medications noted in the protocol
Hemoglobin Measured by "Orsense NBM-200MP" Device and Laboratory Measurement

The purpose of this study is to compare the hemoglobin results obtained with the "Orsense NBM-200MP" device and the Clinical Laboratory.


Eligibility Criteria:
Inclusion Criteria:

* emergency unit patients requiring an hemoglobin determination

Exclusion Criteria:

* none