cyrilzakka/clinical-trials huggingface dataset:
MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED)

The purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with HIV.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age
* Patient is Human Immunodeficiency Virus (HIV) positive
* Patient has documented Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) \<50 copies/milliliter (mL) for at least 3 months while on a KALETRA based regimen
* Patient has been on a KALETRA based regimen for at least 3 months without a change in background antiretroviral therapy
* Patient has no documentation of HIV RNA \>50 copies/mL for at least 3 months while on the KALETRA based regimen

Exclusion Criteria:

* Patient is or plans to become pregnant, or nursing a child
* Patient plans to donate eggs or impregnate/donate sperm
* Patient is receiving Stavudine (d4T) as a component of the background antiretroviral therapy
* Patient is currently receiving a second protease inhibitor in addition to KALETRA
* Patient is currently receiving, or has received in the past twelve weeks, treatment for the management of elevated lipids
* Patient has used another experimental HIV-integrase inhibitor
* Patient has a current (active) diagnosis of acute hepatitis due to any cause
* Patient has used systemic immunosuppressive therapy within one month prior to treatment in this study
Effects of Message Content on Intention to Quit Smoking

Message framing involves "the presentation of choice alternatives, either in a positive or negative manner" (Huber, Neale, \& Northcraft, 1987; p.137). Positively framed health messages contain potential gains of participating/refraining in specific health behaviour. Alternatively, negatively framed health messages contain potential losses of participating/refraining in specific health behaviour (Verlhiac, Chappe, \& Meyer, 2011). The primary aim and rationale of this study will be to investigate which type of framing has the greatest effect on intentions to quit smoking in patients with vascular arterial disease. The secondary aim is to investigate what other factors may have an effect on intention to quit and also what factors play a part in a patient's intention to quit smoking.


Eligibility Criteria:
Inclusion Criteria:

* Peripheral Artery Disease
* daily smoker

Exclusion Criteria:

* psychiatric illness or those who are not literate in English will be excluded from the study as informed consent cannot be obtained. Also, patients who are already participating in any other research involving smoking cessation will be excluded
Universal Stylet Bougie in Patients with Cervical Neck Immobilization.

In patients with cervical spine injury, securing the airway while adequately immobilizing the cervical spine to avoid secondary neurological damage is very challenging. Although awake fiber-optic intubation is the most reliable method in patients with cervical trauma, it has some limitations such as lack of availability, need for expertise in the use, difficulty with non-cooperative patients, or presence of blood or secretions in the airway. Two devices are commonly used to facilitate tracheal intubation: a stylet or a tracheal tube introducer ("bougie").

The Universal Stylet Bougie, or USB™, represents a significant advance in the design and development of tracheal introducers (bougies) and stylets. Traditionally, the design requirements of styles and bougies have always been considered incompatible. A stylet requires sufficient rigidity to allow the tracheal tube to be manipulated to a variety of angles, whereas a bougie needs to be flexible enough to allow positive tracheal ring feedback to allow correct placement.

The unique design of the USB™ means the device can be used as a stylet or as a bougie. It consists of two metals inserted on both sides and a flexible middle section. The USB can easily be manipulated to a variety of angles when used as a stylet, yet has the flexibility when used as a bougie. In addition, the hexagonal shape provides less contact with the inner surface of the tracheal tube, providing particularly easy insertion and removal.

In this study we are simulating a difficult intubating condition by limiting the cervical neck extension through applying a rigid neck collar. Subsequently, we will assess whether using the USB device could improve the successful rate of intubation in these patients.

Eligibility Criteria:
Inclusion Criteria:

1. ASA (American society of Anesthesiologists) physical status 1-2.
2. Age 18- 60 years old of both sexes.
3. Patients undergoing elective surgery under general anesthesia and tracheal intubation.

Exclusion Criteria:

1. Age \< 18 years and ≥ 60 years
2. Pregnancy
3. Patients with BMI \>35 kg m-2
4. Emergency surgery or full stomach
5. Patients with suspected difficult airway {e.g., high neck circumference, airway masses, mouth scars, neck scars, or history of snoring).
6. Patients with cervical spine pathology
7. Patients with any cardiac disorders
Early Intervention For Families Experiencing Homelessness: A Randomized Trial Comparing Two Parenting Programs

This study aims to compare the efficacy in delivering two evidence-based parenting programs to families and young children experiencing homelessness. Outcomes evaluated include feasibility, treatment completion, treatment satisfaction of delivery of interventions as well as child outcomes (e.g., behavior problems, trauma symptoms) and parenting outcomes (parenting stress and parenting skills).

The number of homeless families in the U.S. has increased since the 1980s to over half a million as of 2018. Most troubling, in 2013 (the most recent year for which census data is available) one in every 30 children in the U.S., or 2.5 million, experienced homelessness. In addition to having disproportionally higher rates of unmet health needs (e.g., acute health problems, trauma-related injuries), children experiencing homelessness have staggering mental health needs such that 78% suffer from at least one mental health issue (e.g., depression, behavior problems) along with academic/developmental delays. Given that over half of all homeless children in the US are under the age of 6, it is particularly important to investigate the effectiveness of evidence-based parenting programs within a homeless population. This study aims to compare the efficacy in delivering two evidence-based parenting programs to families and young children experiencing homelessness.

Eligibility Criteria:
Inclusion Criteria:

* Any child between the ages of 2 and 5 and his/her mother who is currently homeless and living in the Lotus House shelter.

Exclusion Criteria:

* Family is already involved in a parenting program or does not speak English or Spanish.
Preoperative Prediction of of Thymic Epithelial Tumors by Diffusion-Weighted MR Imaging

The aim of this study is to analyze aquaporins expression of thymic epithelial tumors and to compare them with apparent diffusion coefficient(ADC) from ultra-high b-values, and to test a possibility of use of ADCuh to identify the pathological type of tumor.

Magnetic resonance (MR) diffusion-weighted imaging (DWI) measures water diffusion in biological tissue. The quantification of diffusion is described by the apparent diffusion coefficient (ADC),which largely depends on the number and separation of barriers.Thus, ADC can provide information regarding tissue microstructure.

According to the literature, ADC is also related to cell membrane permeability for water molecules.It is well known that cellular water transport depends on aquaporins (AQPs).In general,the expression of aquaporins might differ in several pathologic disorders. With reference to this fact,we hypothesize that AQPs expression may influence ADC in thymic epithelial tumors(TETs).Therefore,the aim of the present study is to analyze possible associations between ADC from ultra-high b-values and AQPs expression(ADCuh) in TETs and to use ADCuh to identify the pathological type of tumor.

Eligibility Criteria:
Inclusion Criteria:

* no use of corticosteroid drugs;
* no MRI contraindication;
* no infection or fever;
* tumor diameter is greater than 2cm.

Exclusion Criteria:

-
Clinical Study on the Prevention of Surgical Wound Complications for Aneurysmal Thoracic-abdominal Aortic Pathology Using the "PREVENA" System

The patients will be randomized into two groups of 100 subjects each one. One arm will be randomized to treatment with a negative topical pressure system (Sistema Prevena ™); while the other arm ("control group") will be randomized to treatment with standard medication with sterile gauzes and a TNT patch or medicated patch as normal traditional medication in use.

The medications with a negative topical pressure system (Sistema Prevena ™) will be applied directly in the Operating Room. Thereafter the medication will be checked in the inpatient ward after 48 hours from the intervention, evaluating the possible absorption of exudate on the surface. If no absorption are detected within 48 hours, the medication won't be removed. The medication will be renewed in the 7th day (± 2 days) post-operative; and to follow every 7 (± 2 days) until the points are removed. If the wound continues to progress towards recovery, the protocol will continue until discharge and / or rehabilitation and / or surgery. For each evaluation the photograph of the medication must be taken (which will be deprived of all the identifying elements of the patient).


Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years;
* patients of any sex, race, age, who have accepted to participate in the study by signing the informed consent form of the study.
* patients with surgical wounds to treat thoracic-abdominal aortic pathology.

Exclusion Criteria:

* patients with established sepsis;
* patients with septic recurrence;
* patients with sensitivity to silver.
Fluid Management Study to Evaluate Changes in Intravascular Volume After Applying Various Pressure Levels on the Caval Vein

Fluid therapy optimization in the perioperative period has been considered as major contributor to improve oxygen delivery. A recent, noninvasive approach to estimate fluid requirements in the anesthetized patient with arterial line is the assessment of difference in pulse pressure (dPP). Intraoperative fluid management by dPP is a goal-directed fluid management approach to avoid both hypervolemia and hypovolemia. However, several clinical factors may impede dPP measurements. Surgical manipulations in abdominal procedures may interfere with hemodynamic stability due to obstruction of the caval vein. Physiological considerations make us hypothesize that only intense pressure impedes caval blood flow and thus hemodynamics and dPP. Therefore, the investigators want to assess those changes after standardized application of three different pressure levels (2 N, 5 N, 10 N) on the caval vein.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective hepatic surgery procedures (hemihepatectomy) qualifying for arterial line

Exclusion Criteria:

* pregnancy
* cardiac insufficiency (NYHA 4, EF \< 25 %)
* coronary (CCS 4)
* coagulopathy
* symptoms of infection or sepsis
* malignant hyperthermia
* porphyria
* oesophageal varicose veins
* absence of sinus rhythm
Acute Haemodynamic Effects of Peritoneal Dialysis as Evaluated by Sphygmocor Technology

Subjects with peritoneal dialysis are randomized to different groups. The different groups receive different intra-abdominal volumes and different glucose-concentrations.

The effects on blood pressure and other cardiovascular parameters (e.g. central blood pressure, augmentation index, ...) will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with peritoneal dialysis
* Aged 18-80 years
Detection of Dengue Virus in Plasma of Patients in Nepal

To test whether Karius Infectious Disease Diagnostic Sequencing assay can detect Dengue Virus in plasma from suspected cases of Dengue or Dengue Fever like-illnesses from samples collected as part of a hospital-based multi-site study conducted in Nepal.

Blood samples will be obtained from consented subjects as part of a hospital-based multi-site study conducted in Nepal and will be shipped to Karius, Redwood City, CA.

The investigators will test whether the Karius test can detect Dengue Virus in plasma from those suspected cases and measure the performance of the Karius test against standard tests (PCR, ELISA test and neutralization assays) used to determine a final diagnosis of Dengue Fever.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older, suspected of having Dengue or Dengue Fever-like illnesses.

Exclusion Criteria:

* Inability to understand instructions and comply with study-related procedures, inability to understand and/or sign informed consent, any condition that will prevent the subject from completing the study.
Virtual Assistant for Plastic Surgery Patients

Researchers are trying determine the long term impact when patients have access to the artificial intelligence virtual assistant (AIVA) as a complimentary resource.

Eligible subjects will be randomized into to two groups. One group of subjects will be given access to the AIVA will be instructed to ask, at home, questions regarding the planned surgery to the AIVA application on their mobile phone. The other group will be instructed to call to the Standard of Care call center with questions related to their treatments. Researchers will follow up with all subjects from both groups for a 1 year amount of time.

Eligibility Criteria:
Inclusion Criteria:

* Subjects above 18 years old
* Able to use applications on mobile phones and consent to participate
* Adult subjects in the Plastic Surgery outpatient clinic of Mayo Clinic Florida

Exclusion Criteria:

-
A Study to Evaluate the Drug-drug Interaction and Safety of RLD2301 and RLD2007 in Healthy Volunteers

The purpose of this study is to evaluate the drug-drug interaction and safety of RLD2301 and RLD2007 after oral administration in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age 19\~54 years in healthy volunteers
* 18.5 kg/m\^2 ≤ BMI \< 30 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
* 90 mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \<90 mmHg
* Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who judged ineligible by the investigator
Hepar-P Study to Evaluate the Safety and Efficacy of a Standardised Extract of Phyllanthus Niruri for the Treatment of Non-alcoholic Fatty Liver Disease

This is a multi-center, double blind, parallel group placebo controlled randomised trial designed to determine the safety and efficacy of a Standardised Extract of Phyllanthus Niruri (EPN 797) HEPAR-P capsule for the treatment of Non-alcoholic Fatty Liver Disease for a treatment period of 48 weeks


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant females age 18 years or older
* Written informed consent obtained from patient or parents/ guardian
* Elevated serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels but less than 2.5times the upper limit of the normal range
* Patients with liver biopsy confirmed possible or definite steatohepatitis within the past 12 months prior to enrolment into the trial
* Possible steatohepatitis with activity score ≥3 OR definite steatohepatitis with activity score ≥5
* A score of at least 1 for hepatocellular ballooning

Exclusion Criteria:

* Pregnant or nursing woman or women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having negative pregnancy test
* Participation in any trial in which the patient received an investigational product within 30 days preceding the screening phase of this study
* Those persons directly involved in the conduct of the study
* Alcohol consumption of more than 20g per day for women or more than 30g per day for men for at least 3 consecutive months during the previous 5 years, as assessed with the use of the Lifetime Drinking History questionnaire and the interview version of the Alcohol Use and Disorders Identification Test (AUDIT)
* History of cirrhosis, hepatitis C or other liver diseases
* History of heart failure (New York Association Class II to IV)
* History of taking medications known to cause steatohepatitis
* Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study
Caregivers' eCourse for Recovery After Hip Fracture

In this two part study, we will seek 1. general feedback on the feasibility of an online education and skill development program for family/caregivers of older adults recovering from a surgically repaired low-trauma hip fracture. We will also 2. test its feasibility and acceptability with family caregivers.

This is a cross-sectional mixed methods study to obtain feedback from health providers and family caregivers on eCourse for the post-hip fracture period. For participants who access the course via the PI's website, participants will only be asked to provide feedback on the content, layout, and delivery of the eCourse.

Eligibility Criteria:
Inclusion Criteria:

* Family/caregivers of older adults with hip fracture, health providers, older adults, and/or general public

Exclusion Criteria:

* Adults less than 19 years of age
Promoting Oral Health Among Smokers Randomized Trial

The current study will test the effectiveness of a multi-modal behavioral intervention (the Oral Health 4 Life program) targeted to smokers who are ready to quit smoking and seeking services through tobacco quitlines.

The investigators hypothesize that, compared to people in the control arm, participants in the enhanced intervention will:

1. Be more likely to quit smoking as evidenced by 7 day point prevalent abstinence rates at 6 month follow-up \[primary outcome\] and at 2 month follow-up \[secondary outcome\].
2. Be more likely to see a dental care professional in the past 6 months at 6 month follow-up \[primary outcome\].
3. Exhibit more positive change in relevant oral health knowledge/beliefs and attitudes (e.g., self-efficacy, motivation) that could influence future behavior change.

Smokers (n = 722; 10 pilot participants and 712 main trial participants) will be recruited when they call to enroll in services with their state-supported tobacco quitline program. Eligible smokers who provide consent and complete the baseline assessment will be randomized to either usual care quitline intervention plus attention-matched text messaging or an enhanced program which integrates standard tobacco cessation counseling with a multi-modal, behavioral oral health promotion program.

Follow-up assessments will be conducted by phone at 2 and 6 months post-enrollment. In addition to examining primary and secondary outcomes of interest (focused on tobacco cessation and utilization of professional dental care), change in potentially relevant intermediate process measures and the incremental cost of delivering the Oral Health 4 Life program will be examined.

Eligibility Criteria:
Inclusion criteria:

* Male or female, aged 18 or older
* Eligible for multi-call services through a participating tobacco quitline managed by Alere Wellbeing
* Can read and speak in English
* Current daily smoker and smokes at least 5 cigarettes a day
* Interested in quitting smoking in next 30 days
* Have some or all natural teeth
* Have not visited a dentist for a checkup or teeth cleaning in the past 6 months and do not have an appointment scheduled in the next 6 months
* Has a cell phone capable of receiving text messages and provides cell phone number
* Has internet access for personal use
* Willing to talk about ways to improve their oral health
* Provides verbal consent to participate

Exclusion criteria:

* Self-report a diagnosis of bipolar disorder, mania, schizophrenia, dementia (e.g., has significant cognitive impairment)
* Have lived at the current address less than 6 months or plans to move in the next 6 months
* Are currently enrolled in an in-patient substance abuse treatment facility or are incarcerated
* Has a household member already enrolled in the study, based on self-report and/or mailing address on file
Bacterial Microbiota Characterization on Implant-supported PEEK and Titanium Provisional Abutments

The aim of this study is to determine the relative abundances of the different bacterial phyla and families in the microbiota present on the surface of PEEK implant-supported provisional abutments compared to titanium implant-supported provisional abutments, as well as the effect of both materials on the presence of antibiotics resistance genes.

The use of provisional abutments is mandatory during the restorative phase of any implant based oral rehabilitation. The introduction of poly-ether-ether-ketone (PEEK) for the manufacturing of provisional abutments as an alternative to conventional titanium abutments has opened the restorative spectra, offering the clinician and the patient better aesthetics and adhesive outcomes than its predecessor. However, there is to date no clarity on the impact of PEEK on the bacterial growth and the specificity of the microbiota on the abutment surface. Therefore, the present study aims to determine the relative abundances of the different bacterial phyla and families in the microbiota present on the surface of PEEK and titanium implant-supported provisional abutments, as well as the effect of both materials on the presence of antibiotics resistance genes.

Study Hypotheses:

* H1: The characteristics of the bacterial microbiota present at the connection area of implant-supported provisional abutments are dependent upon the abutment material.
* H2: An increased presence of antibiotic resistance genes is found in the bacterial microbiota on titanium provisional abutments when compared to that found on PEEK abutments.

The study uses a metagenomic approach based on the characterization of the bacterial communities, as well as on the sequencing of the 16S gene, and on the other hand, on the sequencing of the high-throughput (HTS) of the whole genome, for variations of the antibiotic resistance genes.

Sample retrieval will be conducted prior to implant placement, at the adjacent teeth gingival sulcus (t0), and two months after provisional abutment (and crown) connection (t1), from the retrieved abutments. Patient allocation in the "PEEK" or "Titanium" groups will be randomized. Intra- and interpatient comparisons will be conducted. Statistical analyses include two-way ANOVA and Tukey's post-hoc test, at p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* ASA I patients
* Indication of implant treatment to replace an upper or lower premolar
* Presence of natural teeth adjacent to the implant region
* Gingival biotype in the posterior region of 3 to 4 mm

Exclusion Criteria:

* Immunosuppressed patients
* Tabacco, alcohol or drug addictions
* History of periodontal disease
* Need of bone grafting in the implant region