cyrilzakka/clinical-trials huggingface dataset:
A Study to Explore Pharmacokinetic Interaction Between Rilpivirine and Metformin in Healthy Participants

The purpose of the study is to evaluate the effect of steady-state (constant concentration of medication in the blood) rilpivirine on pharmacokinetics (how a single dose of metformin is absorbed in the body, distributed within the body, and removed from the body) of a single dose of metformin, over time, in healthy adult participants.

This is a phase I, open-label (all people know the identity of the intervention) and sequential study (study medication is given in a sequence) in healthy participants, to investigate the pharmacokinetic interaction between steady-state rilpivirine and a single dose of metformin. The study consists of 3 phases including, the screening phase (28 days before enrollment), treatment phase (19 days), and the follow-up phase (7 days after the last intake of study medication). All participants will receive study medications in two sessions in a fixed, sequential order as a session 1 (a single dose of metformin on Day 1) followed by washout period (period when no treatment is received) of 4 days and then session 2 (rilpivirine on Day 5 to Day 17 with a single dose of metformin on Day 15). The duration of the study is approximately 54 days. Safety evaluations including adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination (including skin examination) will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants should be healthy on the basis of physical examination, medical history, vital signs, electrocardiogram, the results of blood biochemistry and hematology tests and a urinalysis performed at screening
* Participant must have a Body Mass Index of 18.5 to 30.0 kg/m2
* Male participants should agree to protocol-defined use of effective contraception and women must be postmenopausal or surgically sterile
* Female participants must have a negative pregnancy test at screening
* Participants must be non-smoking for at least 3 months prior to screening

Exclusion Criteria:

* A positive Human immunodeficiency virus (HIV)-1 or HIV-2 test and Hepatitis A, B or C infection at screening
* Currently active clinically significant gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, endocrine, renal, hepatic, respiratory, inflammatory or infectious disease with any history of clinically significant skin disease
* Any history of tuberculosis, ocular herpes, or uveitis
* Have previously participated in more than one study with etravirine - TMC120 (dapivirine) and/or rilpivirine
* Participants with abnormal laboratory values at screening
Comparison of Different Drilling Speed to Classify Bone Quality by Tactile Sensation on a Saw Bone Model

Comparison of different drilling speed to classify bone quality by tactile sensation on a saw bone model

Bone quality is one of the major factors influencing the dental implant survival rate. Bone quality is believed to have effects on initial implant stability and success of osseointegration. Different implant designs and surgical protocols were developed for improving the survival rate in different bone quality. Although bone quality can be partly diagnosed by radiographic images, lots of experienced surgeons also evaluate bone quality with tactile sensation when they drill the bone. However, variations in evaluation of bone density maybe exist among different surgeons. The drilling speed also may have effect on the outcome of evaluation. For less experienced dentists, it is difficult to diagnose bone quality with tactile sensation in the beginning. The purpose of this study is to find proper drilling speed to classify bone quality by tactile sensation on a saw bone model. Saw bones of variant densities are used as training \& testing materials. The proper drilling speed to distinguish different bone quality will be evaluated and offered to junior dentists for better implant treatment outcome.

Eligibility Criteria:
Inclusion Criteria:

* Adult dentist, with license no more than 5 years
* No clinical implant surgery experience or with experience less than 10 implants.

Exclusion Criteria:

-Subject who couldn't hold the test procedure
Lung Transplant Specimen Repository and Data Registry Protocol

All patients enrolled in the registry will be recipients of single and double lung transplantation (bilateral sequential, heart-lung, or living related donor grafts). During the routine management of lung recipients frequent surveillance of the lung allograft is necessary. This routinely involves: measurement of pulmonary functions, chest radiography, collection of peripheral blood to assess other organ function and monitor therapeutic drug levels, and bronchoscopic evaluation allowing for collection of lung lavage fluid and lung tissue biopsy. This surveillance normally follows a set schedule during the first one to two years following the transplant procedure. Surveillance is routinely performed at weeks 2, 8, 12, 24, 36, and 52 during the first year following the transplant procedure. Additional surveillance may be performed at any time when clinically indicated for the optimal management of the recipient. Information and specimens collected from each of these encounters will be entered in the data registry and specimen repository.

The collection of disposable lung allograft (transplant tissue samples), blood samples and information from medical records for storage, future analysis and research. Stored samples will be available to other researchers who have obtained separate review and approval from an ethics committee called an Institutional Review Board.

Immediately prior to the transplant surgery, the surgeon or pulmonologist will routinely examine the lungs via bronchoscopy during which subjects will be medicated for pain.

The samples that are obtained during this and post-surgery (clinically scheduled) bronchoscopies, including bronchial lavage, are either sent to pathology or are discarded if they do not qualify to go to pathology. For this research, the researchers are asking that the samples that do not qualify for pathology be placed into the repository instead of being thrown away.

Eligibility Criteria:
Inclusion Criteria:

* recipients of single and double lung transplantation (bilateral sequential, heart-lung, or living related donor grafts).
Compassion Cultivation Training for Nurses

The purpose of this study is to evaluate the feasibility of implementing a Compassion Cultivation Training (CCT) program for oncology nurses at Sylvester Comprehensive Cancer Center. The goal of CCT is to provide a structured and systematic way of cultivating daily-life skills needed to strengthen qualities of compassion, empathy, and kindness for oneself and others. CCT typically includes (i) eight weekly 2-hour classes and (ii) daily practice. The in-class activities include pedagogical instruction and active group discussion, guided meditation, interactive practical exercises, and sharing of inspiring readings/stories to prime feelings of open-heartedness or connection to others.

The Compassion Cultivation Training (CCT) protocol is a secular course that was developed by the Center for Compassion \& Altruism Research and Education (CCARE) at Stanford University, School of Medicine (Jinpa, 2013). The course was developed by Thupten Jinpa, PhD, in collaboration with contemplative scholars, psychologists, and scientist at Stanford. The goal of CCT is to provide a structured and systematic way of cultivating daily-life skills needed to strengthen qualities of compassion, empathy, and kindness for oneself and others. CCT typically includes (i) eight weekly 2-hour classes and (ii) daily practice. The in-class activities include pedagogical instruction and active group discussion, guided meditation, interactive practical exercises, and sharing of inspiring readings/stories to prime feelings of open-heartedness or connection to others. The daily practice includes both formal and informal practices. Participants are provided with formal guided meditations that are 15 to 30 minutes long in the form of MP3 or cds. Participants may receive practices and instructions via email with a link to the location of the MP3. They will be provided with practice logs to report their amount of practice as well as some basic observations to the research team. In the present study, we will follow the official CCT manual. The training is composed of 8 sessions, which can be delivered in 7-10 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Be 18 years of age or older
2. Be willing and able to give informed consent
3. Be a Registered Nurse (RN)
4. Currently works at Sylvester Comprehensive Cancer Center
5. Currently works at least 20 hours/week
6. Be able to speak and read English

Exclusion Criteria:

1. Any participants who are deemed to present an acute safety risk to self or others.
2. Any infants, children, or teenagers under 18 years of age.
3. Prisoners
Virtual Reality Exposure Therapy for Combat

This non inferiority trial will compare Prolonged Exposure with Virtual Reality Exposure Therapy in adult patients with combat related PTSD.

Posttraumatic stress disorder (PTSD) affects a significant number of combat soldiers, with some studies suggesting 20% have PTSD. PTSD is related to a number of other detrimental effects, on the individual, such as mood disorders and alcohol abuse, on family members, and on society at large. Although effective treatments for PTSD exist, primarily types of cognitive behavior therapy, their uptake is very low. Studies have shown that a variety of factors act as barriers to care. These include not having the time for therapy, no therapy being locally available, and general stigma about therapy. In military populations, this stigma includes worries about the attitudes of unit members and commanding officers. As a result, many combat veterans do not seek therapy. Recently, it has been suggested that providing therapy in non-conventional settings might overcome some of these barriers. Studies over the last decade have shown that using Virtual Reality is a potential option. Virtual reality is a computer based environment that allows the therapist complete control over its multimedia components. VR is easily adaptable to exposure based treatments, where patients gradually come into contact with feared situations. VR for PTSD following combat, terror and motor vehicle accidents have all shown to be effective treatments. The studies so far are few, involve a small number of patients, and have often not adhered to gold standards of controlled trials. In addition, VR for combat in Israel has never been developed or tested.

The current study is a randomized controlled trial, that will compare traditional face-to-face treatment with Virtual Reality, for combat related PTSD. Blind assessors will examine levels of PTSD and other disorders before treatment, immediately after treatment, and at 6 month follow up.

Eligibility Criteria:
Inclusion Criteria:

* combat related PTSD; Hebrew first language

Exclusion Criteria:

* suicidality, other psychiatric diagnosis requiring treatment, concurrent treatment,
Preoperative Prediction of Microvascular Invasion in Hepatocellular Carcinoma

Microvascular invasion (MVI) has been well demonstrated as an unfavorable prognostic factor for hepatocellular carcinoma (HCC), and patients with MVI have a high risk of tumor recurrence after curative hepatectomy. Currently, the diagnosis of MVI is determined on the postoperative histologic examination, which greatly limits its influence on preoperative decision making. Therefore, we constructed this prospective study to develop a machine learning-based model for preoperative prediction of MVI by extracting high-dimensional magnetic resonance (MR) image features.

Histologically-diagnosed primary HCC after curative hepatectomy. The magnetic resonance image will be imported into the imaging management software (GE healthcare Analysis-Kit software),and the tumor lesions will manually delineated by two independent radiologists and then reconstruct into three-dimensional images for feature extraction. The radiomic textural features including grayscale histogram, transform matrix, wavelet transform and filter transformation are automatically extracted by the Analysis-Kit software.The high-throughput extracted features will be then selected by the univariate analysis, and a prediction model will be developed based on machine learning algorithm in a training set in which patients were collected from a retrospective study. And in the present study, an independent validation set will be collected and used to validate the prediction accuracy of the model.

Eligibility Criteria:
Inclusion Criteria:

* Asian patients aged 18～80 years old;
* HCC without macroscopic vascular invasion according to imaging findings;
* Child Pugh A-B stage;
* Receipt of preoperative Gd-EOB-DTPA enhanced MR imaging of the abdomen within one month before surgery;
* Histologically-diagnosed primary HCC after curative hepatectomy;

Exclusion Criteria:

* Combined hepatocellular-cholangiocarcinoma;
* With extra-hepatic metastasis or macrovascular invasion;
* With incomplete clinical and imaging data;
* Non-radical resection;
Culturally Modified Family Based Therapy for Haitian Youth in South Florida

The CIFFTA study is a unique intervention that will develop and implement a culturally-specific, family-based individual, drug use, sexual risk and delinquency risk reduction program for Haitian youth ages 13-17 in Miami-Dade County, Florida.

Haitian youth in Miami-Dade County who become part of the juvenile justice system have not received culturally appropriate remediating or rehabilitative attention by that system. This study will modify a specific variety of intervention, the Culturally Informed and Flexible Family-Based Treatment for Adolescents (CIFFTA) for appropriateness in Miami's Haitian cultural contexts. This study will develop and implement a culturally specific, family-based adolescent therapy, drug use, sexual risk and delinquency risk reduction program for Haitian adolescents aged 13-17 in Miami-Dade County, Florida.

Eligibility Criteria:
Inclusion Criteria :

* Adolescents aged 13 to 17
* Place of residence is Miami-Dade
* Has Haitian ancestry
* Adolescents not incarcerated
* No prior mental health care or history of psychoactive medication
* Adolescents who have lived in the US for 3 years

Exclusion Criteria:

- Youths with a documented history of mental retardation and/or organic dysfunction.
Rapid Diagnostic Test for Influenza

The primary objective of this study is to evaluate the performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI).

This is a multicenter, prospective study to evaluate the performance of the MSD Influenza Test for the detection and differentiation of influenza A (including A/H1, A/H3, and A/H5 subtypes) and influenza B. Nasal swabs from subjects presenting at the clinical care facility with ILI will be collected and tested on the MSD Influenza Test. Results from the Test will be compared to results obtained from viral culture performed on a second nasal swab at a reference laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Any subject (all ages) presenting with ILI (defined as fever \[subjective or documented\] and cough or sore throat), and suspected of having influenza.
* Subject (parent, guardian, or authorized legal representative) gives informed consent to the study, and provides signed authorization for use and disclosure of protected health information.

Exclusion Criteria:

* Subjects who had prior nasal wash/aspirate or nasopharyngeal wash/aspirate specimens collected for routine health-care purposes within the same suspected influenza infection episode.
* Unable to collect nasal and throat swab.
* Severely ill patient without a family relative to provide informed consent.
White Adipose Tissue Clocks and High Calorie Feeding

Peripheral tissues (e.g. liver, adipose, muscle) express self-sustained circadian clocks that coordinate daily metabolic rhythms. The timing of clock rhythms in peripheral tissues is highly sensitive to feeding-fasting signals across the sleep-wake transition. Nutritional insults such as high fat overfeeding (HF-OF) have been shown to attenuate clock gene expression in peripheral tissues resulting in a deleterious re-programming of the circadian metabolome. Studies in humans have only superficially investigated how the circadian clock machinery is impacted by nutritional signals. The overall goal of this pilot project is to take the first steps toward developing translational methods to investigate links between changes in energy flux and the circadian system in human tissues. Using an innovative ex vivo cell culture approach the investigators will examine the impact of 3-days of HF-OF compared to eucaloric (EU) feeding on the expression of core clock genes in human subcutaneous adipose tissue (SAT). The Investigators hypothesize that compared to EU, the amplitude of clock gene expression in SAT measured over 24hrs will be attenuated following short-term HF-OF. This pilot project will serve as a launch point for designing future studies into the effects of diet and exercise on the circadian control of metabolism in adipose tissue depots as well as other tissues (e.g. muscle).


Eligibility Criteria:
Inclusion Criteria:

* males and females aged 20-35 yr;
* BMI 25-35 kg/m2 and weight stable (±2kg in past 2mo);
* non-smoker;
* sedentary to moderately active (≤3 days of exercise per week ≤30 min of exercise per session);
* sleeping pattern of \>7 hours to 9.25 hrs of sleep/night.
* subjects will be asked to identify themselves as regular consumers of 3 balanced meals per day by answering the question: "Do you eat breakfast, lunch, and dinner on ≥ 5 days per week?"

Exclusion Criteria:

* Smoker (current or within the previous 3 months);
* Use any medication that could affect lipid metabolism, insulin signaling, or sleep;
* Pregnant women will not be enrolled in the study;
* Have a job that involves shift work;
* Dwelling below Denver altitude (1,600 m) a year prior to testing;
* Travel across more than one time zone 3 wk before a study;
* chronic health conditions such as diabetes, hyper or hypothyroidism, renal or liver disease, anemia, or cancer;
* Regularly go to sleep after midnight;

  o Subjects will be excluded if they are identified as having night eating syndrome (at least 25% of food intake is consumed after the evening meal and/or at least two episodes of nocturnal eating per week);
* Allergy to lidocaine or similar compound;
* Have one or more of the following out-of-range values measured on a fasting blood sample:

  * glucose \> 110 mg/dl,
  * thyroid stimulating hormone \<0.5 or \>5.0 µU/ml.
* Subjects who may be:

  * anemic (hemoglobin \< 14.5 g/dl men, \<12.3 g/dl women ),
  * have abnormal liver function tests (alanine amino transferase \> 47 U/l, aspartate aminotransferase, \> 47 U/l, alkaline phosphatase \<39 or \>117 U/l) or creatinine (\>1.1 mg/dl).
Maintenance Treatment for Children With Constipation

Constipation is a common problem among children. The majority of children suffering from constipation have no underlying disease. Although constipation has no basis in underlying disease, it often leads to a reduced quality of life of children who are on par with or worse than for children suffering from serious diseases such as cardiovascular and rheumatic diseases.

Despite the high frequency of constipation among children, little is known about the causes and treatment of constipation.

Treatment consists of symptomatic treatment with various laxatives. Movicol and Movicol junior has proven very effective and are therefore widely used in children as disimpaction and maintenance treatment. There is currently no research to prove the need for and length of maintenance treatment with laxative medications in children.

The purpose is to examining the effectiveness of maintenance treatment with Movicol. Additional til study will examine how the anal diameter change during a course of treatment and the degree to which it can be used as an indicator of treatment efficacy.

The study will test the following:

• What is the effect of maintenance treatment with PEG compared to placebo?

The results from this study are expected to form the basis for an evidence-based approach to the use of maintenance therapy and the use of ultrasound of the rectum in children with constipation.


Eligibility Criteria:
Inclusion Criteria:

* Children between 2 and 16 years and referral to our out patient clinic with either constipation or fecal incontinence.
* Patients must fulfill the Rome III criteria of constipation, which mean they must have at least 2 of the following characteristics: fewer than 3 bowel movements weekly, more than 1 episode of fecal incontinence weekly, large stools in the rectum by digital rectal examination or palpable on abdominal examination, occasional passing of large stools, display of retentive posturing and withholding behavior, and painful defecation.

Exclusion Criteria:

* Children with known organic causes of constipation, including Hirsprung disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases.
* Children receiving drugs known to affect bowel function during a 2 month period before initiation.
* The healthy control group consists of children with no history of constipation (Rome III), urinary incontinence, urinary tract infections, fecal incontinence, laxative use or any other disease affecting the digestive system.
* Children receiving medications known to affect bowel function are excluded from the study.