cyrilzakka/clinical-trials huggingface dataset:
Effect of Intravenous Lidocaine, Used to Attenuate Pain With Propofol Injection, on Defibrillation Threshold Testing

The use of lidocaine, as an anesthetic drug, during implantation of an implantable cardioverter-defibrillator(ICD)will not result in a clinically significant alteration of the defibrillation threshold during ICD placement.

Summary: The purpose is to observe the incidence of successful defibrillation on the first attempt during implantation of an implantable cardioverter-defibrillator (ICD) among patients who receive a standard dose of intravenous lidocaine (for attenuation of pain associated with propofol injection) versus patients who do not receive an intravenous lidocaine dose.

During implantation of an ICD, defibrillation threshold (DFT) testing is performed. DFT is calibrated as the lowest energy delivered by the ICD that will successfully terminate malignant arrhythmia. Lidocaine, a routine anesthetic agent, is also identified as an antiarrhythmic drug. Experimentally, lidocaine has been shown to increase thresholds during DFT' testing due to the drugs dual effect. The rationale behind this project is that the lidocaine may yield falsely elevated DFT, resulting in higher calibration of the ICD device. This alteration can affect ICD battery and overall ICD life. Comparisons between study groups may elucidate effects of IV lidocaine on DFT.

Eligibility Criteria:
Inclusion Criteria:

* Any person referred to the Hahnemann University Hospital Electrophysiology Laboratory for a clinically indicated ICD implant

Exclusion Criteria:

* Any person under the age of 18 years
* Inability to give an informed consent
* Allergy to lidocaine
* Receiving lidocaine treatment for pain or arrhythmia
* Contraindication for DFT testing
* Not consenting for DFT testing
* Receiving energy other than 10-12.5 joules as initial DFT test
* Implant of ICD on the right side
* DFT not planned to be performed during ICD implant
* Epicardial placement of ICD leads
* Use of single coil ICD lead
* Subpectoral ICD implantation
* Cephalic cutdown used for central venous access
* Require more than 3mg/kg of 1% SQ lidocaine for local anesthesia
* Pregnant women or prisoners
Atorvastatin Study For The Treatment Of High Cholesterol In Patients From Thailand

The purpose of this study is to evaluate the efficacy of atorvastatin in lowering cholesterol on patients from Thailand with high cholesterol.


Eligibility Criteria:
Inclusion Criteria:

* Dyslipidemic patients who were eligible for lipid lowering therapy
* Willingness to follow study diet for 1 month prior to screening and for the duration of the study

Exclusion Criteria:

* Use of other lipid lowering agents (6-week washout period)
* Uncontrolled high blood pressure
* Impaired liver function
Subjective Feelings of Job Stress and Frontal Activity During Verbal Fluency Test: A Near-infrared Spectroscopy Study

Background and objectives:

Recently the news of intern doctors' death due to overloaded work or committing suicide has made the authorities concerned put emphasis on the mental health care of medical staffs and related policies of psychological interventions. The prefrontal lobe plays an important role in the working memory, executive function and problem-solving abilities of the brain. Currently, no neuroimaging studies investigating the impact of job stress on the prefrontal love functions in intern doctors. Functional near-infrared spectroscopy (fNIRS) measures the cortical functions of the frontotemporal regions and has been widely used as a biomarker to aid in differential diagnoses in major psychiatric illnesses in Japan. The present study will investigate impact of the job stress on brain cortical activity during a verbal fluency test (VFT) by using fNIRS.

Materials and methods:

A total of 100 participants will be recruited. Clinical measurements of mood status by Beck's Depression Inventory and Beck's Anxiety Inventory, as well as job stress by Chinese Version of the Job Content Questionnaire and the Chinese version of Copenhagen Burnout Inventory will be arranged. The relationship between clinical measurements and cortical activity during a VFT will be analyzed by Pearson's correlation. Multiple regression analysis will be applied to investigate the independent contributions of mood status and job stress.

Expected results and contributions of the study:

Job stress, depression, and anxiety are significantly negatively correlated with cortical activity of prefrontal regions. The importance of mental health of medical staffs under high job stress should be stressed.

A total of 100 intern doctors will be recruited. The data including Chinese version of Copenhagen burnout inventory, BDI, BAI, average working hours per day, and average sleeping times were acquired. They will undergo NIRS investigations to detect frontal activities during performing a verbal fluency test. The correlation between stress parameters and cortical activities were examined.

Eligibility Criteria:
Inclusion Criteria:

* medical intern doctors who are willing to participate in the study.

Exclusion Criteria:

* with past psychiatric disease
* with history substance abuse or dependence
* with history neurological disorders or head trauma
Effects of a 12-week Suspension Versus Free Weight Training Program on Body Composition and Handgrip Strength in Older Men

The present investigation lasted a total of 16 weeks, of which 4 were employed for assessment and measurements and 12 weeks were used for the exercise treatment. The participants underwent two different training programs carried out in three weekly 75-min sessions, on alternate days (Mondays, Wednesdays and Fridays, in the morning). Each session of both training programs consisted of a warm-up at the beginning and general stretching at the end. The exercises used in the suspension training program were: squat, rear deltoid row, biceps curl, chest press, low row, rotational ward, split squat whit Y deltoid fly, triceps pushdown. The exercises used in the free weight training program were: squat with support, unilateral squat, hip adduction and abduction, calves, hip flexor, alternating curl, French triceps press, and high row. Eleven participants were included in the control group.


Eligibility Criteria:
Inclusion Criteria:

* not having chronic disabling diseases
* not being bedridden institutionalized or hospitalized
* have their own mobility, without assistance from people, even if they have the aid of devices -without amputations.

Exclusion Criteria:

* the use of pacemakers and the presence of chronic and uncontrolled metabolic diseases
Characterizing PAI-1 Modulation on Monocyte Adhesion

To determine how altering the expression of a gene known as PAI-1 may affect the adhesive capacity of cells that play a critical role in the developement of human atherosclerosis.

The principal aim of this study is to determine if molecular regulation of the human gene PAI-1 alters the migratory properties of human myeloid and endothelial cells sufficiently enough to regulate entry and exit from the vascular space. Human monocyte become the key cellular orchestrators of human atherosclerotic plaque. We believe that a "loss" of PAI-1 activity may promote a pro-atherogenic effect in human vasculature thereby defining a novel atheroprotective effect for PAI-1 when expressed at normal levels in humans. By using RNA interference to achieve PAI-1 gene, we hope to elucidate the mechanistic basis of how PAI-1 regulation may affect human migration within the vasculature.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-50
* No current or past medical problems

Exclusion Criteria:

* Patients taking prescription drugs (hormonal birth control or herbal supplements may be taken)
A Study to Evaluate Endoscope-assisted, Minimally-invasive Cortical Access System for Chronic Subdural Evacuation

The purpose of this study is to evaluate a less-invasive alternative to the currently available method of removing aging blood in the subdural space.


Eligibility Criteria:
Inclusion Criteria:

* Must be 55 years of age or greater.
* Have a clinically symptomatic chronic subdural hematoma greater than 1 cm in maximal thickness and be judged clinically to need subdural evacuation.

Exclusion Criteria:

* Failure to obtain consent.
* Vulnerable study population.
* Any need for chronic anticoagulation.
* Pregnancy (verified by pregnancy testing at screening or medical history of a hysterectomy, oophorectomy, or post-menopausal).Prior surgery for subdural hematoma.
* Glasgow Coma Scale (GCS) less than 8.
Sustaining the Reach of a Scalable Weight Loss Intervention Through Financial Incentives

This study seeks to assess how different incentive strategies may reduce the initial attrition gap when implementing weight management in a primary care clinic predominantly serving African American patients. This will be done through an innovative research-practice partnership involving primary care, research expertise, and a small business. Participants will be randomly assigned to one of four financial incentive conditions respectively tied to: weight loss, weigh-ins, weigh-ins and weight-loss, and incentive choice. Participants will be followed for 3 and 6 months to assess program reach, sustaining the reach after initial weigh-in, and weight loss outcomes based on records on participant enrollment and subsequent weigh-ins automatically collected through a kiosk at the clinic.

The proposed study "Sustaining the Reach of a Scalable Weight Loss Intervention through Financial Incentives: an Exploratory Randomized Trial" seeks to assess how the use of different incentive strategies may reduce the initial attrition gap when implementing weight management in a primary care clinic predominantly serving African American patients through an innovative research-practice partnership involving primary care, research expertise, and a small business.

The sample will include approximately 200 persons ages 19+ from Nebraska Medicine or the greater Omaha community. The inclusion criteria are (1) age 19+ years; (2) are obese (BMI \>=30) or overweight (BMI \>=25 yet smaller than 30); (3) have internet access. Following the completion of an automated informed consent embedded within the program registration using a kiosk placed at the Fontenelle Clinic, we plan to conduct a 4-arm, pragmatic randomized controlled trial (RCT) that will randomly assign overweight/obese patients at the Nebraska Medicine Fontenelle clinic to one of four financial incentive conditions respectively tied to: weight loss, weigh-ins, weigh-ins and weight-loss, and incentive choice, following the completion of an automated informed consent embedded within the program registration and initial weigh-in. Participants will be followed for 3 and 6 months to assess program reach, sustaining the reach after initial weigh-in, and weight loss outcomes based on records on participant enrollment and subsequent weigh-ins automatically collected through a kiosk placed at the Fontenelle clinic.

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese participants who are of 19 years or older and have internet access

Exclusion Criteria:

* Not meeting the inclusion criteria.
Feasibility Study of the Online High School Media Aware Program

This is a pretest-posttest feasibility study of Media Aware Sexual Health - High School, an interactive web-based comprehensive sexual health media literacy education program for high school students. The program is designed to develop students' critical thinking skills and promote sexual health. It is hypothesized that this program will enhance adolescents' media literacy skills, sexual health knowledge, cognitions (i.e., attitudes, self-efficacy, and norms), and behaviors regarding healthy sexual decision-making.


Eligibility Criteria:
Inclusion Criteria:

1. Students must be in grades 9 or 10 in participating classrooms at participating schools.
2. Students must be able to speak and read English because the study materials (e.g., questionnaires) and the program are in English.
3. Students must have appropriate permissions to receive sex education per school districts' policy (i.e., opt-in policy or opt-out policy).
Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide

The overarching goal of this study is to examine the acute vasoreactive response to both inhaled nitric oxide and inhaled epoprostenol across both traditionally and non-traditionally interrogated phenotypes in PH, and to further characterize the relationship of vasoreactivity to disease severity and PH phenotype.


Eligibility Criteria:
Inclusion Criteria:

* mPAP ≥ 21mmHg, PAWP ≤ 25mmHg, and PVR ≥3 WU
* Classified as WHO group I-III pulmonary hypertension

Exclusion Criteria:

* WHO group IV and V pulmonary hypertension
* Patients who are on baseline pulmonary vasodilator medications
* Severe aortic or mitral valve disease
* Patients who are pregnant
* Left ventricular ejection fraction of \<35%
* Patients who are hospitalized as inpatients at the time of RHC
* Patients with systolic blood pressure \<90mmHg or mean arterial pressure of \< 60mmHg
A Prospective Pharmacodynamic Study of Rivaroxaban

The ability to explain bleeding or clotting complications in patients treated with rivaroxaban remains challenging. In addition, there is limited data on how coagulation tests perform in patients treated with therapeutic doses of rivaroxaban. Predicted responses of coagulation tests to therapeutic doses of rivaroxaban may be helpful in better understanding abnormal responses to rivaroxaban. The purpose of the study is to define a therapeutic reference range for peak and trough coagulation tests in patients taking FDA approved doses of rivaroxaban and to determine which tests may be most clinically useful for monitoring rivaroxaban.


Eligibility Criteria:
Inclusion Criteria:

Person taking therapeutic dose of Rivaroxaban

Exclusion Criteria:

* CrCl \< 15 mL/min
* Non-FDA approved dose based on calculated CrCl with most recent SCr
* Age \< 18 years
* Inability to communicate in the English language
* Decisionally-impaired individuals
* Incarcerated
* Pregnant/Lactating (Pregnancy category: C, unevaluated effects in lactation)
Retrospective Evaluation of Prosthetic Complications and Peri-implant Bone Resorption in Implant-supported Single Unit Fixed Restorations

This study evaluated the one-year outcomes of implant-supported single-tooth fixed restorations used to replace missing teeth. The aim was to assess the success rates of dental implants and identify potential complications during treatment. A total of 100 individuals aged between 20 and 64 participated in the study. Patients were evaluated one year after their implant treatments through clinical examinations and radiographic imaging.

Aim: The aim of this study was to retrospectively investigate the prosthetic complications and peri-implant bone loss by clinical and radiological examination at the 12th month of implantsupported single-unit fixed restorations.

Materials and Methods: In this retrospective study, 100 volunteer patients, aged between 20 and 64, who received implant-supported single-member fixed restoration treatment, were scanned from the archives and included. The patients were scanned from the archives, called for 12-month follow-ups, and clinical and radiographic evaluations were made. G\*Power (G\*Power Ver. 3.0.10, Franz Faul, Üniversität Kiel, Germany) package program was used to calculate the sample size. Digital radiographs (periapical-panoramic films) taken from the patients at the end of the implant treatment and at the 12th month follow-up were recorded using Planmeca Romexis® software. ImageJ, a digital image analysis program, was used to evaluate marginal bone loss on radiographs (ImageJ 1.54g- Wayne Rasband and Contributons, National institutes of Health, USA). In evaluating the success and survival of the implants, the criteria in the consensus decisions published at the International Oral Implantology Congress in 2007 were taken as basis. In addition, prosthetic complications such as chipping, screw loosening and decementation; Its relationship with anatomical localization, implant length, implant diameter, abutment type, superstructure material, occlusal table and the condition of the opposing arch was evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Participants were required to be over 18
* Not to have any systemic disorders
* Not to smoke
* Have provided consent to the study.

Exclusion Criteria:

* Individuals with any systemic or psychiatric disorders
* Who did not have radiographic data immediately after prosthetic loading
Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)

This study will investigate the effects of a reservoir nasal cannula (Oxymizer®) compared to a conventional nasal cannula (CNC) in patients with idiopathic pulmonary fibrosis.

Patients will be recruited during a 3-week inpatient pulmonary rehabilitation program. They will perform the following three interventions on consecutive days and will repeat them after a week. During these days the time table for prescribed physical activities and therapies will be kept in a comparable fashion.

The following 3 interventions will be performed in randomized order:

Day A: The Patient wears a conventional nasal cannula for 12 h with oxygen flow rate as prescribed during ADL

Day B: The Patient wears the Oxymizer® with prescribed oxygen flow rate for 12 h during ADL

Day C: The patient wears the Oxymizer® with a flow rate reduced by 1l/min in comparison to the prescribed oxygen flow rate, for 12h

The following week the same measurements will be repeated. The mean of the corresponding two measures will be calculated for each approach.

Eligibility Criteria:
Inclusion Criteria:

* IPF patients with indication for long term oxygen therapy ≥ 2l/min
* VC \>30% and \< 70% pred.

Exclusion Criteria:

* failure to comply with study process
* acute infection
Effect of Vicriviroc on HIV Ribonucleic Acid (RNA) Levels in Cerebrospinal Fluid (Study P05241)

Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5 receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells that fight infection). Previous studies in HIV treatment-experienced patients have shown that vicriviroc is safe and effective. The purpose of this study is to determine the effect of vicriviroc on HIV RNA levels in cerebrospinal fluid (CSF).

This is a nonrandomized, open-label, multicenter study to investigate the HIV antiviral response in CSF when vicriviroc is added for 2 weeks to the subject's failing antiretroviral background regimen. The primary efficacy endpoint of this study is the mean change in log10 CSF HIV RNA from baseline at Week 2. The secondary efficacy endpoint is the proportion of subjects achieving CSF HIV RNA \<50 copies/mL at Week 2. At Week 2, the subject's background regimen will be optimized and vicriviroc continued up to Week 24. After completing Week 24 of the study, subjects will be offered the option to continue on open-label VCV 30 mg once daily, if appropriate, until commercially available or until the sponsor terminates the clinical development of VCV. Subjects who discontinue vicriviroc for any reason will be requested to participate in long-term follow up.

Eligibility Criteria:
Inclusion Criteria:

* A subject must be at least 18 years of age at the time of study entry, of either sex, and of any race.
* A subject must be infected with HIV-1 virus, as documented by a positive assay for HIV-1 RNA in plasma, prior to Screening.
* A subject's HIV isolate must be solely CCR5-tropic at Screening (ie, a subject must not have detectable CXCR4-tropic or dual/mixed CCR5/CXCR4-tropic HIV isolates).
* Subjects must be failing their current antiretroviral regimen with plasma HIV RNA \>=1000 copies/mL at the time of screening. (Note: The failing background regimen must contain a ritonavir-boosted PI, and may not include an NNRTI.)
* A subject must be willing to undergo study procedures including lumbar punctures, and to adhere to the chosen antiretroviral regimen.
* A subject must have a pretreatment CSF HIV RNA of \>=200 copies/mL.

Exclusion Criteria:

* A subject must not be taking medication for seizure control or have any condition that, in the judgment of the investigator, is likely to increase the risk of seizures.
* A subject must not have a prior history of malignancy (with the exception of surgically resected basal cell carcinoma with clear margins or Kaposi's sarcoma without visceral or mucosal involvement that resolved without systemic anticancer treatment).
* A subject must not have a contraindication to lumbar puncture (eg, bleeding diathesis or use of anticoagulants).
Evaluation Study of Web-based Resource for Youth

This study will evaluate DigiKnowIt News, a web-based resource to educate youth about pediatric clinical research. Youth will be randomly assigned to one of three groups (1. Intervention Version A; 2) Intervention Version B; 3) Wait-list control).

Compared to the high numbers of clinical trials with adults, there are far fewer clinical trials with children and adolescents; highlighting the need for more clinical trials with pediatric populations. Lacking in the area of pediatric clinical research are resources to educate children and adolescents about clinical research in fun, interactive, and developmentally appropriate ways. Thus, a web-based resource, DigiKnowIt News, was developed for youth aged 8 to 14 years to educate youth about participating in pediatric clinical trials. The web-based resource includes video spotlights, investigations, and electronic comic books. The purpose of this study is to conduct a randomized controlled trial to determine the effectiveness of the web-based resource and examine its impact on youths' knowledge about pediatric clinical trials, self-efficacy about making decisions about participation in clinical research, and positive attitudes towards participation.

Eligibility Criteria:
Inclusion Criteria:

* Within the ages of 8 and 14 years of age

Exclusion Criteria:

* Does not speak English fluently, does not have access to a computer or tablet with internet connection, and or has participated in a clinical trial after kindergarten.
Botulinum-assisted Orbital Fat Augmentation With PRP (Platelet-rich-plasma)

immobilization of yoked extra-ocular muscles in the anophthalmic orbit, in conjunction with platelet-rich-plasma, will improve integration of viable adipocytes injected into orbital fat

Immobilization of tissue (graft, graft bed) is a prerequisite for tissue integration. Since yoked extra-ocular muscles continue to be stimulated by movements of the seeing eye after fat injection into the anophthalmic orbit, the use of botulinum toxin(s) can be used to prevent movement of the orbital tissue bed(s) and improve anchoring of injected fat. Platelet rich plasma may also improve fat cell anchoring by the action of fibrin on the adhesion process. This innovation builds on the results of IRB protocols 10.27 and 12.01 as registered with Clinical Trials.gov

Eligibility Criteria:
Inclusion Criteria:

* anophthalmic enophthalmos in subjects within a 50 mile radius of New York City, grade 0-1 anesthesia risk, ages 21-75

Exclusion Criteria:

* radiated orbits