cyrilzakka/clinical-trials huggingface dataset:
The Most Appropriate Parameter Correlates With Clinical Effectiveness of Vancomycin: Trough Drug Concentration or Area Under Curve (AUC)/Minimum Inhibitory Concentration (MIC)?

The purpose of this study is to evaluate which is the most appropriate parameter correlates with clinical effectiveness of vancomycin: trough drug level or AUC/MIC.

Several studies have shown AUC/MIC to be the better pharmacokinetic-pharmacodynamic parameter for clinical effectiveness of vancomycin. However, the 2009 consensus guideline for vancomycin therapeutic monitoring continued to recommend trough serum concentration monitoring in the clinical setting. In 2011, Patel et al showed that highly difference between AUC(72-96h) and Cmin(96h). Different dosing and creatinine clearance may reach the same trough drug level with different AUC. The investigators wonder whether trough drug level can serve as a substitute marker for AUC and as a parameter for vancomycin therapeutic monitoring.

In this study, the investigators will calculate AUC/MIC of vancomycin with published formula, analyze its correlation with patient's clinical outcome and compare that with trough drug level.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients of National Taiwan University Hospital
* Age above or equal to 20 years old
* Positive methicillin-resistant Staphylococcus aureus blood culture
* Receiving vancomycin therapy for definitive use
* Undergoing therapeutic drug monitoring (had serum vancomycin concentration level)

Exclusion Criteria:

* Age below 20 years old
* Without details of vancomycin dose and frequency
* Vancomycin treatment shorter than 72 hours
* Without renal function data (serum creatinine level, creatinine clearance)
* Without infection-related clinical outcomes (lab data such as white blood cell count , seg, C reactive protein , body temperature records)
* Receiving renal replacement therapy
* Therapeutic drug monitoring before reaching steady state
* With abnormal and undefined serum concentration
Overall and Disease Specific Survival in Patients With Confirmed MEN1 With or Without PNET (Pancreatic Neuroendocrine Tumors)

OBJECTIVES:

The primary objective of this study is to evaluate the effect of estrogen on the development of the PNET in MEN1 patients.

The secondary objective is to evaluate the overall survival and disease specific survival in patients who have confirmed MEN1 with or without PNET and a pancreatic neuroendocrine tumor in relation to their hormone status. The secondary objective is to evaluate clinicopathologic features in relation to hormone status.

Retrospective review of a prospectively maintained MEN1 database. The patient cohort consists of all patients with confirmed MEN1 with or without PNET who are included in the database. The database will be reviewed to obtain patient and disease characteristics, laboratory values, imaging results, hormone parameters (menopausal status, bioidentical hormone use, oral contraception use, gestational status and diagnosis of a prolactinoma) and vital status.

For the prospective portion of this study, investigators want to see the impact of estrogen on the PNET forming and progression, and would like to use two equations to assess the estrogen exposure, so investigators should collect the information of menopause, menarche, breast feed, HRT, OCP use and pregnancy. To this end, investigators will contact female patients in the database who are still living, and obtain verbal informed consent to send an email questionnaire regarding their pregnancy and hormone use history.

Eligibility Criteria:
Inclusion Criteria:

1. The patient cohort for this study consists of all patients within the prospectively maintained MEN1 database within the Department of Surgical Oncology at the University of Texas MD Anderson Cancer Center.
2. Patients with a diagnosis of MEN1 with or without PNET based on mutational analysis or defined clinical criteria were considered.
3. All patients for whom hormone status variables and survival data are available will be included.

Exclusion Criteria:

1. Due to the nature of the questions included in the prospective estrogen questionnaire, only female patients will be verbally consented to receive the questionnaire and obtain prospective data.
Impact Evaluation of the Teen Choice Program

The purpose of this study is to evaluate the impact of the Teen Choice program on reducing the rates of unprotected sex of high risk youth in New York.

This study uses a randomized controlled design to compare the impacts of the Teen Choice Program to the "business-as-usual" school curriculum. The Teen Choice curriculum is designed for adolescents aged 12 to 19 and will be delivered in different formats that range in length from 6 to 12 weeks. Teen Choice will be offered during the regular school day to middle and high school aged youth. This study is being conducted as part of the national Personal Responsibility Education Program evaluation funded by Administration for Children and Families within the U.S. Department of Health and Human Services.

Eligibility Criteria:
Inclusion Criteria:

* Age 12-19
* Attending one of the participating schools

Exclusion Criteria:

* Juvenile Justice Youth
* School clinician determined trauma histories
* School clinician determined developmental issues
A Study to Evaluate the Absorption, Metabolism, and Excretion and Absolute Bioavailability of Xevinapant in Healthy Male Participants

The purpose of the study is to determine absorption, metabolism, and excretion of a single oral dose of \[14C\]-xevinapant. This information will enable assessment of absorption and clearance mechanisms of \[14C\]-xevinapant as well as identify metabolites. In addition, the study will allow to determine absolute bioavailability of xevinapant and understand its intravenous pharmacokinetics.


Eligibility Criteria:
Inclusion Criteria:

* Part 1: Males of any race, between 35 and 65 years of age, inclusive. Part 2: Males of any race, between 18 and 65 years of age, inclusive
* Body mass index between 18.0 and 30.0 kilograms per meter square (kg/m\^2), inclusive
* Weight between 50 kilograms (kg) and 110 kg, inclusive
* History of a minimum of 1 bowel movement per day.
* Willing to adhere to the prohibitions and restrictions specified in the study protocol

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee)
* History of alcohol consumption of \>21 units per week. One unit of alcohol equals 12 ounce (oz) \[360 millilitre (mL)\] beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
* Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing, or less than 5 times the half-life, whichever is longer, prior to administration of study drug
* Poor peripheral venous access
* Have participated in any clinical study involving a radiolabeled investigational product within 12 months prior to check-in.
Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX)

The primary purpose of this study is to compare the efficacy of AZD2171 in combination with FOLFOX to the efficacy of bevacizumab in combination with FOLFOX, in the second-line treatment of patients with metastatic colorectal cancer


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of colon or rectal cancer,
* Received prior systemic therapy for cancer,
* Cancer must have progressed during or after first treatment

Exclusion Criteria:

* Prior treatment with a VEGF inhibitor,
* Poorly controlled hypertension
MK0859 Dose-Ranging Study (0859-003)

To assess the cholesterol changing effects of MK0859 in patients with primary hypercholesterolemia or mixed dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients will be men and women of non-child bearing potential, 18 through 75 years of age diagnosed with high cholesterol

Exclusion Criteria:

* Patients with CHD or CHD-equivalent disease (except diabetes)
* Diabetics on statins
Effectiveness of AZT and Nevirapine in Preventing HIV Transmission From Ugandan Mothers to Their Newborns

The purpose of this study is to see if nevirapine (NVP) or zidovudine (AZT), given to mothers during labor and delivery and to their babies during the first week of life, can reduce the rate of mothers passing HIV to their babies.

About 25 percent of HIV-infected mothers pass HIV infection to their babies during labor and delivery. There is an urgent need to find a simpler way to prevent mother-to-infant transmission during labor and delivery. The proposed NVP schedule is simpler and possibly could be used in Uganda.

There is an urgent need to find a safe, effective means of preventing mother-to-infant HIV transmission that would also be applicable and affordable in developing-country settings. The frequency of vertical HIV-1 transmission is estimated to be 25 percent. The proposed trial specifically will test the hypothesis that chemoprophylaxis of the fetus/neonate during labor and delivery and the first week of life may significantly reduce the risk of perinatal HIV-1 transmission.

Pregnant women infected with HIV-1 are randomized to 1 of 4 study arms and receive either NVP or its placebo, or AZT or its placebo. Mothers in the NVP group receive a single dose of NVP or placebo at the onset of labor and are followed to 6 to 8 weeks after delivery. Infants born to these mothers receive at 48 to 72 hours post-delivery or discharge, whichever comes first, a regimen of the same treatment (NVP or placebo) given to the mother. Infants are followed for 18 months post-delivery by clinical and laboratory evaluation to determine toxicity, evidence of HIV-1 infection, and clinical disease progression.

Mothers in the AZT group receive either a bolus of AZT or its placebo at onset of labor, then doses every 3 hours until delivery, with follow-up to 6 to 8 weeks. Infants begin receiving either a lower dose of AZT or placebo as soon as they can tolerate liquids by mouth, twice daily for 7 days, and are followed for 18 months as in the NVP group.

Eligibility Criteria:
Inclusion Criteria

Mothers may be eligible for this study if they:

* Have been pregnant for more than 32 weeks and are at least 18 years of age.
* Are HIV-positive.
* Reside within 15 km of Mulago Hospital, the study site.
* Infants may be eligible for this study if they:
* Are born to mothers enrolled in the study.
* Have consent of the mother/guardian and, if available, the father.

Exclusion Criteria

Mothers will not be eligible for this study if they:

* Have a serious infection or illness other than HIV.
* Currently take any anti-HIV drugs.
* Participate during this pregnancy in another treatment vaccine perinatal trial.
* Received NVP or AZT within the last 6 months.
* Are allergic to any benzodiazepine.
* Abuse alcohol or other drugs.
* Have high blood pressure that is not controlled.
* Have received any anticoagulants, benzodiazepines other than the study drug, or magnesium sulfate within 2 weeks before being assigned to a study group or delivery.
* Infants will not be eligible for this study if:
* Their mother is excluded prior to being assigned to a study group.
Airway Deadspace in Children: Air-Q Versus Endotracheal Tube

The objective of this study will be to measure the airway deadspace associated with use of appropriately sized an AirQ, a commonly used supraglottic airway in young children weighing between 5 and 20 kg and compare that to the airway deadspace associated with use of an endotracheal tube (ETT) in similarly sized children undergoing controlled ventilation.

There is an increasing interest in the use of supraglottic airway devices in progressively younger and younger patients. One issue that has not been well evaluated is the contribution of these devices to airway dead space in young children and infants. Volumetric capnography is the only non-invasive technology available at the current time to evaluate airway deadspace. Volumetric capnography essentially monitors the flow of CO2 over time and from the expired waveform one can determine different respiratory parameters including dead space. This is clinically important in young children as the clinician begins to evaluate whether or not to use an endotracheal tube or supraglottic airway in these patients. To perform this investigation the study team will use volumetric capnography to examine the airway dead space associated with these devices during and elective general surgery and urologic procedures in healthy children between the ages of 0 and 6 years of age (roughly 5-20 kg).

Participants in the study will be given ETT or Air-Q as an intervention, but the investigator does not assign specific interventions to the study participants.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 3 months and 6 years of age weighing between 5 and 20 kg
* Patient presenting outpatient urologic or general surgery

Exclusion Criteria:

* History of difficult airway/intubation
* Patients suspected to have a difficult airway.
* Morbid obesity BMI \>39
* Emergency status of surgery
* Patients exposed to second hand smoke
* Patients with Asthma
* Patients with a URI symptom such as nasal drainage, cough, or fever within 7 days of the date of surgery
* History of Prematurity
Effectiveness of Adacel Vaccination in Pregnancy at Preventing Pertussis in Infants < 2 Months of Age in the United States

The purpose of this study is to determine the effectiveness of Adacel against pertussis disease in infants \< 2 months when administered during pregnancy following the current Advisory Committee on Immunization Practices (ACIP) recommendations, i.e., from 27 to 36 weeks of gestation, and 14 days or more before delivery.

The original study included cases recorded from 01 January 2011 through 31 December 2014, based on retrospective case-control methodology.

Eligibility Criteria:
Inclusion Criteria:

Cases were included if they met the following inclusion criteria:

* Reported pertussis disease in the referenced EIP surveillance database
* Age greater than 2 days and younger than two months of age
* Resided in the catchment area on date of onset of their cough
* Born in a hospital in their state of residence
* ≥ 37 weeks of gestation at birth
* Not adopted, in foster care or living in a residential care facility
* Completed maternal interview
* Completed infant and maternal information

Controls were included if they met the following inclusion criteria:

* Age greater than 2 days and younger than 2 months of age on date of cough onset for the corresponding case infant
* Resided in the catchment area on date of cough onset for the corresponding case infant
* Born in a hospital in their state of residence
* ≥ 37 weeks of gestation at birth
* Not adopted, in foster care or living in a residential care facility
* Maternal interview completed
* Infant and maternal information complete

Exclusion Criteria:

Cases were excluded if they met any of the following exclusion criteria:

* Vaccination status of the mother unknown
* Infants whose mothers were vaccinated with Boostrix or an unknown vaccine brand

Controls were excluded if they met any of the following exclusion criteria:

* Vaccination status of the mother unknown
* A pertussis diagnosis prior to the cough onset date of the corresponding case infant
* Controls that were matched to Boostrix or an unknown brand cases
Comparison of Remimazolam and Propofol Effect on Oxygenation Reservoir During Diagnostic Gastric Endoscopy

Propofol is one of the most commonly used sedative in endoscopic procedures, while its potency to induce respiratory depression may threaten patient safety. Remimazolam is known to less likely induce hemodynamic instability when compared to propofol, yet its favorable effects are not clearly evaluated in endoscopic procedures. Hence, this study aimed to compare hemodynamic effects of remimazolam and propofol, by evaluating oxygen reserve index (ORI) in patients scheduled for diagnostic gastric endoscopy.


Eligibility Criteria:
Inclusion Criteria:

Patients (age 19\~80 yrs, ASA Class I\~III, ECOG 0\~1) who are scheduled for elective diagnostic gastric endoscopy

Exclusion Criteria:

Pregnancy Allergy to remimazolam or propofol Underlying pulmonary diseases or obstructive sleep apnea Hypotension (SBP \<80mmHg) or hypoxemia (SpO2 \<90%) assessed prior to procedure
Atorvastatin Three Year Pediatric Study

The purpose of this study is to characterize three year descriptive growth and development (ie, height, weight, body mass index, Tanner Stage) and efficacy of cholesterol reduction in pediatric subjects with Heterozygous Familial Hypercholesterolemia receiving atorvastatin treatment.


Eligibility Criteria:
Inclusion Criteria:

* Heterozygous familial hypercholesterolemia, ages 6-15, LDL greater than 4 mmol/l

Exclusion Criteria:

* Active liver disease or hepatic dysfunction, or persistent elevations of serum transaminases exceeding three times the upper limit of normal (ULN).

Female of childbearing potential who is not using adequate contraceptive measures or any female who is pregnant or breastfeeding. Any female who becomes pregnant during study participation will be immediately discontinued from treatment and counseled appropriately about the in utero exposure.

Known hypersensitivities to HMG-CoA reductase inhibitors
Comparison of Two Summative Assessment Methods in Advanced Life Support Courses

Several approaches for summative assessment during Advanced Life Support courses are used. The most commonly used method during European Resuscitation (ERC) Council Life Support Courses is that 1 instructor is miming a whole team, and the candidate has to lead this "team" through a scenario; another variant of the summative assessment (mainly used by American Heart Association (AHA) Courses) is with a group of students, where one student is the team leader to be assessed and the others are his team not being assessed. The second approach might be more realistic; however there is no evidence around with regard to effectiveness (pass/fail rate, ability to test non-technical skills (NTS)) or participant/assessor satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* All medical students at the University of Bern, study year 2017/2018, 5th and 6th study year

Exclusion Criteria:

* Refusal to participate
Evaluation of the Effect on Glucose Control and Safety of AC2993 in Patients With Type 2 Diabetes Treated With Metformin, Sulfonylurea, or Metformin and Sulfonylurea Combination

This multi-center, open-label study is designed to examine the effects on long-term glucose control and safety of AC2993 in patients with type 2 diabetes treated with metformin, sulfonylurea, or metformin and sulfonylurea combination.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes
* Treated for at least 3 months prior to screening either with metformin, sulfonylurea, or metformin and sulfonylurea combination
* BMI 25-45 kg/m\^2
* HbA1c between 7.5 % and 12.0 %, inclusive

Exclusion Criteria:

* Treated with other oral anti-diabetic agents other than metformin and sulfonylureas within 3 months of screening
* Patients previously treated with AC2993
* Patients presently treated with insulin
A Phase 1 Dose Escalation Study of VX-973 in Healthy Adults

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of VX-973 in healthy participants.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2)
* A total body weight of more than (\>) 50 kg
* Participants of non-childbearing potential
* Nonsmoker or ex-smoker for at least 3 months before screening

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.
Improving Arm and Hand Functions in Chronic Stroke (CIHR 2012-2015)

Improving arm and hand function after stroke has been difficult to achieve within the rehabilitation service provided in the acute stage often due to the limited resource in health care. While spontaneous recovery plateaus after 6 months, the prolonged disability affects quality of life and social participation in stroke survivors. This study is aimed at improving chronic motor impairment arm and hand impairment by providing the intervention with intensive training schedule. This study will compare two types of rehabilitation intervention using a randomized controlled trial. Measurements also will be taken on various brain functions non-invasively to help discover how each of the intervention strategies works differently to repair the brain.

After unilateral stroke, incomplete recovery of arm and hand movement is common and its long-lasting negative effects include increased care giving costs and overall reduced quality of life. Recent evidence suggests that a novel behavioral intervention could improve motor functions in sub-acute patients with added benefits in cognitive and brain functions. However few studies have addressed whether chronic stage patients can also benefit from the intervention and how brain plasticity works over the course of rehabilitation. This study will investigate the benefits of two types of intervention methods that are extendable for community-based intervention services in the future. It also will examine changes in integrity of motions before and after the intervention. Further comparisons between brain functions and structure will be made using magnetoencephalography (MEG) and magnetic resonance imaging (MRI), non-invasively. These behavioural and physiological measures will inform the mechanisms of stroke recovery and training.

Eligibility Criteria:
Inclusion Criteria:

* post-acute stroke patients with unilateral first-time MCA stroke sustained . (more than 6 months ago prior to the enrolment to the study).
* Patients' residual motor impairments in the affected hand and arm should be greater than stage 3 on the Chedoke McMaster scale.

Exclusion Criteria:

* Patients with moderate apraxia, aphasia or dementia, and patients with severe sensory loss in the paretic hand, severe language-communication disability, posture problems, involuntary movements, high-blood pressure, depression or other psychological disorders, metal in body that interferes with MEG and MRI measurements.
A Pilot Study of the Envision® Surface

This study is to evaluate the clinical safety and effectiveness of the Envision® surface.

This study is to evaluate the clinical safety and effectiveness of the Envision® surface placed on the TotalCare® frame in pressure ulcer prevention and management, patient comfort, and staff acceptance in the critical care environment

Eligibility Criteria:
Inclusion Criteria:

* Subject weighs between 70 and 400 pounds Subject to remain on Envision Surface for at least 3 days Subject at risk for pressure ulcers (Braden Score \< 14) or has existing ulcer of any stage Subject is able to provide voluntary consent

Exclusion Criteria:

* Subject requires pulmonary treatment surface Subject declines consent