cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality for the Improvement of Patients Understanding of Disease and Treatment (MRgRT)

This clinical trial explores if using virtual reality (VR) headsets will help to improve patient understanding of their disease and decrease anxiety about treatment. Three-dimensional (3D) images may help the patient visualize their tumor and location better and therefore understand potential side effects. Visualizing a virtual representation of the magnetic resonance imaging (MRI) linear accelerator (Linac) may decrease treatment related anxiety.

PRIMARY OBJECTIVE:

I. Examine patient reported comprehension of their tumor characteristics and treatment plan following 3D virtual reality review of their imaging.

SECONDARY OBJECTIVE:

I. Examine patient reported treatment related anxiety prior to and following virtual reality (VR) simulation of the MRI Linac treatment process.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT I: Patients receive two-dimensional (2D) image review using standard computer screen on study. Patients undergo MRI and computed tomography (CT) imaging at screening and on study.

COHORT II: Patients receive image review using virtual reality stimulation on study. Patients also view MRI treatment room using virtual reality stimulation. Patients undergo MRI and CT imaging at screening and on study.

Eligibility Criteria:
Inclusion Criteria:

* Age: above 18 years
* Participants must be histologically proven neoplasm
* Planned to undergo radiation treatment using the MR Linac

Exclusion Criteria:

* Inability to tolerate virtual reality headset
* Non-English speaking patients
* Pediatric patients are ineligible
Complement Regulatory Proteins Expression and Clinical Response in Rheumatoid Arthritis (RA) Patients Treated With Rituximab

There is a correlation between the CD55, CD59, CD35 and CD46 expression on B lymphocytes of patients before and after treatment with rituximab and the level of depletion and repopulation time for these cells. The theoretical rationale of the study assumes that the correlation, if any, will be a negative correlation. However, the hypothesis of positive correlation (two-tailed test) will also be tested.

Rituximab, an anti-CD20 monoclonal antibody, is a new alternative treatment for patients with severe immune diseases and resistance to conventional treatment. One of the mechanisms of action of this drug is the complement-mediated lysis. Most RA patients respond well to rituximab treatment, however, some are refractory and mechanism of this non-response is still unclear. The role of CD55 and CD59 protein and its overexpression as a mechanism of resistance to rituximab treatment in lymphoma patients have been investigated. However, there has not been studied a correlation between the intensity of expression of these regulatory molecules on B cells of RA patients and resistance to treatment with Rituximab.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of both gender, aged greater than or equal to 18 years; and lower than 70 years.
2. Patients diagnosed with RA for at least 6 months according to the criteria of the American College of Rheumatology (ACR) in 1987 for classification of AR.
3. Patients with a medical indication for therapy with rituximab, with prescription of this therapy for the first time and have not yet received the first dose.
4. DAS28 score greater than or equal to 3.2.
5. Use of adequate contraception, as judged from the attending physician.
6. Desire to participate voluntarily, the ability to understand the protocol, documented by signing the consent form (attached).

Exclusion Criteria:

1. overlapping rheumatic disease, autoimmune lymphoproliferative and neoplastic.
2. active infection, patients with the use of cytotoxic drugs, presence of positive serology for HCV, HBV and HIV, active or latent tuberculosis.
3. allergy or hypersensitivity to rituximab.
4. pregnant woman or performing breastfeeding.
5. participating in another clinical study with intervention.
6. with functional class IV defined based on the criteria of Steinbrocker functional classification for RA.
7. prior therapy with Rituximab.
Cervical Cancer Screening Project Part C

This proposal has been developed through collaboration between the University of Minnesota and New American Community Services (NACS), and the research design is based on a needs assessment conducted by the community partner. The investigators will test the hypotheses that women who are offered home vaginal bio-specimen collection will have higher rate of cervical cancer screening completion than that of women referred for clinic-based Pap test. All participants will be given identical education materials on cervical cancer screening and HPV, currently in use by the Minnesota Sage Program.

The trial will pilot text a protocol for home vaginal bio-specimen collection for human papillomavirus (HPV) testing for cervical cancer screening. The main objective is to estimate the successful screening completion rate among a sample of Somali women who have not undergone cervical cancer screening for three or more years. Women will be randomized to either home vaginal bio-specimen collection or referral to undergo a clinic-based Pap test.

Eligibility Criteria:
Inclusion Criteria:

* Somali female age 25-70 years

  * have lived in the U.S. 10 years or less
  * have not had a Pap test (by self report) in the last 3 years

Exclusion Criteria:

* Women with a self reported past history of any of the following will not be eligible:

  * total hysterectomy
  * cervical cancer
  * active history of cervical dysplasia
Pilot Randomized Controlled Trial of the INSIGHT Program

This randomized controlled trial aimed to assess the efficacy of a new intervention program for perpetrators of child sexual abuse: the INSIGHT Program. The primary outcome measures to assessing INSIGHT effectiveness will include psychological symptoms, EMSs, cognitive distortions, interpersonal problems, self-esteem, victim empathy, and empathy, and sexual violence risk. Then, qualitative interviews will enable an in-depth examination of the therapeutic process and its effects.

Perpetrators of CSA will be recruited from Portuguese Prisons. Potential participants who are likely to meet inclusion criteria will be identified and referred to study staff by prison members.

Participants who agreed to participate gave written informed consent, completed the baseline assessment, and were randomly assigned to treatment conditions (treatment and control groups) using a random number table by a research assistant who was blind to any information about each participant.

Besides baseline assessment, participants completed the post-treatment assessment (at the end of INSIGHT Program) and follow-up assessment (3 months after INSIGHT completion).

The program's structured and manualized design ensures integrity, at least partially.

Eligibility Criteria:
Inclusion Criteria:

* male;
* men with convictions of a sexual crime against a child

Exclusion Criteria:

* men with cognitive disabilities;
* men with psychotic symptoms;
* men with higher traits of psychopathy;
* men with addiction to alcohol/drugs;
* men with convictions for child pornography and/or rape (i.e., adult victims)
* men in prison less than 12 months since the beginning of the program
* Female;
* men having low risk of sexual recidivism
A Comparison of Sample Collection Methods for SARS-COV-2 Antibody Testing

The negative global consequences of the COVID-19 pandemic has prompted efforts to develop efficient laboratory testing protocols that can be quickly scaled in a practical way. Traditional phlebotomy requirements for antibody testing (venipuncture) often serve as a barrier to widespread population testing since they typically require dedicated facilities and personnel training. Conversely, antibodies are typically very stable in blood and require very little testing volume, which make antibody tests well suited to be run on samples collected via finger-stick, saliva, or other self-administered collection devices. Salveo Diagnostics is a CLIA/CAP certified clinical laboratory that routinely performs testing for anti-SARS-Cov-2 antibodies. The purposes of this protocol are to 1) assess the feasibility of streamlined sample collection procedures for assessing COVID-related immune status, and 2) to provide a mechanism for securing sequential samples in COVID positive and negative patients to support additional studies (e.g. investigating timing of anti-SARS-CoV-2 antibody class switching and antibody persistence).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed presence (N = 200) or absence (N = 100) of anti-SARS-COV2 antibodies
* \>17 years old

Exclusion Criteria:

* Refusal or inability to provide informed consent
Shared Decision Making in Rural Primary Care Lung Cancer Screening and Smoking Cessation

The intervention is aimed to improve adherence to the lung cancer screening (LCS) guidelines and Centers for Medicare and Medicaid Services (CMS) coverage criteria to conduct shared decision-making (SDM) and provide smoking cessation services in rural primary care practices.

The pilot intervention will engage no more than 300 patients using a pragmatic, pre-post design guided by an enhanced RE-AIM/PRISM framework. The primary goal of this intervention is to improve LCS practice by offering a formal SDM process and smoking cessation support aligned with the CMS coverage criteria. The investigators will conduct a type II effectiveness implementation hybrid trial using a pre-post design to evaluate the effectiveness (co-primary outcomes of LCS and decision quality) and implementation at four rural clinics. Space precludes discussion of pragmatic design features, but this study was designed to be pragmatic using the PRECIS-2 criteria and it scores highly on almost all PRECIS-2 dimensions.

Each clinic will recruit the minimum of 9 patients eligible to LCS (based on CMS guidelines) every 2 months for up to 8 months. The first period of 2 months is for baseline data, the second and every other period of 2 months is for intervention (pre-post design). Each patient will receive 2 surveys (one immediately after the doctor's visit and a second one a month later). The intervention will be in the form of patient decision aid (information flyer) the participant receives during a healthcare provider visit.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic to lung cancer symptoms
* Tobacco smoking history of 20+ pack-years
* Current smoker or quit within last 15 years

Exclusion Criteria:

- A patient that does not meet inclusion criteria
Safety and Bioavailability of IV and SC LBR-101

The purpose of this study is to assess the safety, tolerability and blood levels of LBR-101 when administered intravenously or subcutaneously to healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Generally Healthy, Signed Approved Informed Consent, BMI 17.5-34.5 kg/m2, Willing and able to comply with CRU rules regulations and study schedule

Exclusion Criteria:

* Clinically significant medical or psychiatric condition, Febrile illness within 5 days of dosing, Pregnant or Nursing Females. History of alcoholism, drug addiction or positive drug/alcohol screen, History of hypersensitivity to injected proteins or monoclonal antibodies, Unwilling or unable to comply with the protocol specified lifestyle guidelines, Investigational site staff members, Use of 3 or more prescription or non-prescription medications daily, Acetaminophen use in doses of higher than 1 g or more/day, Daily Aspirin use in higher than 325 mg/day, Treatment with an investigational drug within 30 days of dosing, Use of biologics within 6 months of screening, Any clinically significant abnormality in the 12-Lead ECG, Positive result for HIV, Hepatitis B, or Hepatitis C, Any clinically significant abnormalities in Blood Chemistry Hematology or Urinalysis, Positive Pregnancy Test.
A Pilot Trial in a Sleep Laboratory Setting to Observe Night Time Bladder Function of Subjects With Overactive Bladder (OAB)

This is an observational, pilot, non-treatment study to evaluate and develop clinical variables for distinguishing female OAB subjects that have detrusor overactivity positive (DO+) nocturia from female OAB subjects that have detrusor overactivity negative (DO-) nocturia utilizing a sleep laboratory setting.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have confirmed diagnosis of OAB and OAB symptoms for ≥ 3 months
* Subject must have documented detrusor overactivity
* Subject must not be taking any OAB medication for at least 14 days
* Subject has no sleep related conditions (other than nocturia)

Exclusion Criteria:

* Subject has active urinary tract infection (UTI)
* Subject has significant stress incontinence or mixed stress/urge incontinence
* Subject has nocturnal polyuria
* Subject has history of sleep apnea
* Subject has indwelling urinary catheterization within 4 weeks
* Subject using medication that effects urinary and sleep function
* Subject is unable to refrain from alcohol or smoking during the sleep night stay
* Subject has an unstable medical or psychiatric disorder
* Subject has a history of cardiovascular concerns
* Subject is pregnant, breastfeeding or plans to become pregnant
The Effect of Rapid and Slow Glucose Fall on the Subsequent Glucose Production in People With Type 1 Diabetes

In the effort of better understanding the glucose control in people with type 1 diabetes, in-depth insight into the physiology of hepatic glucose production and its influencing factors is essential. Previously, a number of potential influencing factors of hepatic glucose production have been investigated, including insulin-on-board, low carbohydrate diet, preceding ethanol intake, exercise and multiple stimulations of hepatic glucose production. Previous post-hoc analysis of dual-hormone closed-loop systems has indicated that the rate of fall in blood glucose influences the following stimulation of hepatic glucose response. However, the rate of fall in blood glucose is highly related to insulin levels, which may explain those findings. Thus, in this study the investigators want to examine whether the different rates of fall in blood glucose with similar insulin levels on board affect the hepatic glucose response in individuals with type 1 diabetes. In the study, which will be conducted at Steno Diabetes Center Copenhagen, participants will complete two study visits. On each visit, a hypoglycemic clamp technique will be used to lower the blood glucose levels of the participants (using either a rapid or slow decline rate), whereupon hepatic glucose production will be stimulated using low-dose glucagon. The study days are divided into four phases: 1) preparation phase, 2) hyperinsulinemic euglycemic phase (stabilization of blood glucose), 3) hyperinsulinemic hypoglycemic phase (rapid or slow decline in blood glucose) and 4) post-glucagon administration phase. This design will allow the investigators to examine whether differences in hepatic glucose response exist depending on preceding rate of fall in blood glucose. We hypothesize that the rate of fall in blood glucose does not affect the hepatic glucose production.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years
* Duration of Type 1 Diabetes ≥ 3 years
* Insulin pump use \> 6 months

Exclusion Criteria:

* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
* Allergy or intolerance to lactose or GlucaGen (Novo Nordisk, Bagsværd, DK)
* Use of medications that are known to cause QT interval prolongation
* Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
* Females who have different basal insulin pattern depending on their menstrual cycle
* Inability to understand the individual information and to give informed consent
* Current participation in another clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject
* Other concomitant medical or psychological condition that according to the investigator's assessment makes the individual unsuitable for study participation
Investigation of Non-Invasive Outcomes Predictors in Patients Undergoing DBS for Movement Disorders

The purpose of the study is to determine if non-invasive measurements of brain waves from the skin called electroencephalography (EEG) can predict whether the brain stimulator will help your symptoms. Our goal is to obtain these brain wave measurements with patients both awake and under general anesthesia, and then to evaluate which brain wave patterns are associated with clinical improvement to determine if they could be useful for predicting whether the surgery will work. If such predictive measures were established based upon the findings of this study, they could be used in the future to improve surgical outcomes in the following ways: (1) to help guide surgical targeting in the operating room awake or under anesthesia, (2) to guide post-operative programming in clinic, and (3) and to develop potential feedback systems for "automatic" programming of the brain stimulator system at home.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who elect to undergo deep brain stimulation as part of routine clinical care for movement disorders (Parkinson's disease, essential tremor, dystonia, Tourette's syndrome).
2. Adults, ages 19 and older

Exclusion Criteria:

1. Patients who are outside the age range for inclusion
2. Patients who are unable to consent to the research for cognitive or behavioral reasons
3. Patients who are medically too ill to participate, and
4. Patients who have their DBS programming at outside facilities
A Study of ABT-751 in Patients With Non-Small Cell Lung Cancer

The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with non-small cell lung cancer. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.


Eligibility Criteria:
Inclusion Criteria

* Stage IIIB or IV non-small cell lung cancer.
* Recurrent tumor following treatment with paclitaxel or docetaxel.
* Able to tolerate normal activities of daily living.
* Adequate bone marrow, kidney and liver function.

Exclusion Criteria

* Pregnant or breast feeding.
* Anti-tumor therapy within 4 weeks of the start of ABT-751 administration.
* CNS metastasis.
Alveolar-capillary Reserve After Exercise in Chronic Obstructive Pulmonary Disease (COPD) (COP-DTPA)

It is unknown whether individuals with COPD exhibit abnormal alveolar-capillary breaching during exercise, and whether this contributes to exertional dyspnoea. The aim of this study is to investigate whether individuals with COPD exhibit an abnormal increase in alveolar-capillary breaching during exertion, as indicated by an increase alveolar-capillary permeability with a concomitantly exacerbated increase in lung tissue mass.

It is unknown whether individuals with COPD exhibit abnormal alveolar-capillary breaching during exercise, and whether this contributes to exertional dyspnoea. The aim of this study is to investigate whether individuals with COPD exhibit an abnormal increase in alveolar-capillary breaching during exertion, as indicated by an increase alveolar-capillary permeability with a concomitantly exacerbated increase in lung tissue mass. The study participants include a control group and a group with COPD (GOLD I-III). Participants are undergoing three study days: (1) Measurement of maximal aerobic capacity and lung function test, (2) lung tissue mass and alveolar-capillary permeability is measured at rest and again 2 hours later, immediately after the participant has exercised on a bicycle ergometer and (3) supine cardiac output and pulmonary capillary blood volume will be measured at rest and immediately after exercise.

Eligibility Criteria:
Inclusion criteria - individuals with COPD

* Men and women
* 45-80 years old
* COPD (GOLD stage I to III)
* Resting arterial oxygenation \> 90%

Inclusion criteria - healthy controls

* Men and women
* 45-80 years old
* Non-smokers
* Normal lung function
* Same sex, age (± 3 years) as the COPD group

Exclusion criteria - individuals with COPD

* Symptoms of ischemic heart disease
* Known heart failure
* Symptoms of illness, including fever, within 2 weeks prior to the study
* Pregnancy
* • Known renal or liver diseaseActive smoking (within 3 weeks)

Exclusion criteria - healthy controls

* Known chronic lung disease
* Symptoms of ischemic heart disease
* Known heart failure
* Symptoms of illness, including fever, within 2 weeks prior to the study
* Pregnancy
* Known renal or liver disease
* Active smoking (within 3 weeks)
DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Novolimus Eluting Coronary Bioadaptor System

The goal of this registry is to confirm the safety, and performance of the DynamX Novolimus Eluting Coronary Bioadaptor System in patients with coronary artery disease.

This registry will obtain additional safety, effectiveness, and performance data on the DynamX Novolimus-Eluting Coronary Bioadaptor System in the treatment of patients with ischemic heart disease due to de novo native coronary artery lesions in a real-world patient population.

Eligibility Criteria:
Inclusion Criteria:

1. Over 18 years of age
2. Patient understands the trial requirements and treatment procedures and provides informed consent
3. Patient indicated for PCI with stent implantation and receive at least one DynamX Bioadaptor implant in accordance with the product's Instructions for Use (IFU).

Exclusion Criteria:

1. Target Lesion(s) in the left main artery
2. Prior venous or arterial bypass grafts
3. In-stent restenosis
4. Patient is currently participating in another clinical trial with an investigational device or an investigational drug that has the potential to impact study results (e.g., anti-thrombotic or anti-platelet medications) that has not yet completed its primary endpoint
5. Patient is, in the opinion of the Investigator, unable to comply with the requirements of the study protocol or is unsuitable for the registry for any reason