cyrilzakka/clinical-trials huggingface dataset:
Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection

To quantitate in an HIV-infected population the percentage of patients demonstrating the "booster" phenomenon (attainment of a positive response to a second tuberculin purified protein derivative skin test when the first skin test was negative); to determine the relationship between the booster phenomenon and CD4-positive lymphocyte cell counts; to detect any relationship between the booster phenomenon and HIV exposure category.

The accuracy of skin testing to detect Mycobacterium tuberculosis (MTb) infection is dependent upon the host's ability to mount a delayed-type hypersensitivity (DTH) reaction; however, the DTH response may be impaired or absent in patients with impaired cell-mediated immunity, a classic characteristic of HIV infection. Patients in whom immunity is diminished, but not absent, may test negative the first time a purified protein derivative skin test for MTb is administered, but if the same skin test is repeated, a positive DTH response may then be elicited. This occurrence is known as the "booster" phenomenon.

The accuracy of skin testing to detect Mycobacterium tuberculosis (MTb) infection is dependent upon the host's ability to mount a delayed-type hypersensitivity (DTH) reaction; however, the DTH response may be impaired or absent in patients with impaired cell-mediated immunity, a classic characteristic of HIV infection. Patients in whom immunity is diminished, but not absent, may test negative the first time a purified protein derivative skin test for MTb is administered, but if the same skin test is repeated, a positive DTH response may then be elicited. This occurrence is known as the "booster" phenomenon.

Patients who have had a negative purified protein derivative (PPD) skin test for M. tuberculosis within 7-28 days prior to study entry will receive a second PPD test by the Mantoux method (5 TU intradermally to the volar aspect of the forearm). Skin tests will be read 48-72 hours after application. Patients with a positive skin test (defined as an induration, or small hard knot, of 5 mm or greater forming beneath the skin) will be referred to their primary physicians for further evaluation.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection.
* Negative PPD skin test within previous 7-28 days.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Steroids.
* Live viral vaccines.
* Antihistamines.
* Chemoprophylaxis or chemotherapy for suspected or confirmed tuberculosis.

Patients with the following prior conditions are excluded:

* History of documented positive PPD skin test.
* History of tuberculosis or who are presently receiving chemoprophylaxis or chemotherapy for suspected or confirmed tuberculosis.
* History of sensitivity to tuberculin or components of PPD.

Prior Medication:

Excluded:

* Live viral vaccine within the past 4 weeks.
* Steroid therapy within the past 4 weeks.
* Antihistamines within the past week.
* Chemoprophylaxis or chemotherapy for suspected or confirmed tuberculosis.
A Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (GIST)

The primary objective of this trial is to evaluate the progress free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed with prior anticancer therapies based on independent radiologic review.

The primary objective of this trial is to evaluate the progress free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed with prior anticancer therapies based on independent radiologic review. This study enrolled 39 subjects of 9 sites in China mainland, and all enrolled subjects received DCC-2618 after enrollment as treatment.

The study used EDC to collect patient data and IRT system for patient randomization, using Imaging Endpoints as the central image to evaluate the PFS.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥18 years of age.
* Patients with advanced gastrointestinal stromal tumors.
* Subjects who have progressed or documented intolerance after previous treatments.
* Sign informed consent, understand the Protocol and could follow the Protocol.
* The subject had at least one measurable lesion.
* Adequate organ function and bone marrow reserve

Exclusion Criteria:

* Treatment with anticancer therapy, including investigational therapy, or investigational procedures within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of investigational drug.
* Prior treatment with DCC-2618.
* Previously or currently has an additional malignancy that is progressing or required active treatment, which may interfere with the safety or efficacy evaluation of DCC-2618.
* Patient has known active central nervous system metastases.
* New York Heart Association class II - IV heart disease, active ischemia or any other uncontrolled cardiac condition.
* Arterial thrombotic or embolic events within 6 months before the first dose of investigational drug.
* Venous thrombotic events within 3 months before the first dose of investigational drug.
* 12-lead electrocardiogram (ECG) demonstrating QT interval corrected by Fridericia's formula \>450 ms in males or \>470 ms in females at screening or history of long QT interval syndrome.
* Left ventricular ejection fraction (LVEF) \<50% at screening.
* Use of known substrates or inhibitors of breast cancer resistance protein (BCRP) transporters within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of investigational drug.
* Major surgeries within 4 weeks of the first dose of investigational drug.
* Any other clinically significant comorbidities, which in the judgment of the investigator, could compromise compliance with the protocol, interfere with interpretation of the study results, or predispose the patient to safety risks.
* Active viral infections.
* If female, the patient is pregnant or lactating, or plans to become pregnant during the study treatment period.
* Known allergy or hypersensitivity to any component of the investigational drug.
* Gastrointestinal abnormalities.
* Any active hemorrhages, excluding hemorrhoids or gum bleeding.
Non-Invasive Measurement of SjvO2 Using Near Infrared Spectroscopy in Critically Ill Patients

ScvO2 is an important parameter in the management of critically ill patient. The only way to measure it is to have an internal jugular or subclavian central venous catheter. With this trial, the investigators want to show a positive relationship between invasive ScvO2 measurement and noninvasive SjvO2 measurement with VO 100 medical device from Mespere LifeSciences, allowing the use of SjvO2 as a noninvasive surrogate of ScvO2 in critically ill patients.

ScvO2 measures central venous oxygen saturation level from veins draining the head and upper body while SvO2 measures mixed venous oxygen saturation from the lower and upper half of the body. ScvO2 is more conveniently measured and less risky than Sv02 measurement although a central venous catheter is needed. ScvO2 gives knowledge about the balance between the delivery of oxygen and oxygen consumption in the body. Interest in ScvO2 monitoring in anesthesia and critical care has been debated. However, ScvO2 is still recommended as a major hemodynamic target of early resuscitation of critically ill patients. Even if ScvO2 measurement is far less invasive than SvO2 measurement through pulmonary artery catheter, it is accompanied with morbidity.

VO 100 medical device from Mespere LifeSciences allows a non-invasive measurement of SjvO2 using the NIRS technique. Jugular venous oxygen saturation (SjvO2) is a measurement of the amount of oxygen left in the venous system after the brain has removed the oxygen that it needs.

On the same principle that a positive relationship between ScvO2 and SvO2 has been shown, what the investigators are trying to do is to show a positive relationship between SjvO2 and ScvO2 in order to possibly use in the future SjvO2 measured by VO 100 as a noninvasive surrogate of ScvO2.

Eligibility Criteria:
Inclusion Criteria:

* all ICU adult patients routinely equipped with a central venous catheter placed in internal jugular or subclavian vein allowing ScvO2 measurement from blood sampling.

The investigators will perform this study only on patients already equipped with an internal jugular CVC. In other words, the placement of the CVC is not conditioned by the study realization.

Exclusion Criteria:

* patients with CVC placed in another site than internal jugular vein.
Atomoxetine Versus Placebo in Children With Attention Deficit/Hyperactivity Disorder (ADHD)

Atomoxetine versus placebo in Children with Attention-Deficit/Hyperactivity Disorder (ADHD)


Eligibility Criteria:
Inclusion Criteria:

* Patients are diagnosed with ADHD
* Patients must be able to swallow capsules
* Patients must be of normal intelligence

Exclusion Criteria:

* Patients who weigh less than 15 kg or more than 75 kg
* Patients with organic brain disease (for example, dementia or traumatic brain injury residual)
Stool-based SDC2 DNA Methylation Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer

The primary objective is to compare the performance of Stool-based SDC2 DNA Methylation Test and commercially available Fecal Immunochemical Test(FIT) , on the detection rate of advanced adenomatous polyps and colorectal cancer in Chinese population. Subjects with positive results in either test will receive colonoscopy. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.

A large cohort of participants will be asked to collect stool sample for either Stool-based SDC2 DNA Methylation Test or Fecal Immunochemical Test. Subjects who have positive results will undergo colonoscopy within 6 months.

Representative histopathology slides from tissue biopsied or excised during colonoscopy and those from subsequent definitive surgery may be retrieved in order to be evaluated by pathologists to confirm the diagnosis and staging.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is average risk for development of colorectal cancer.
2. Subject is able and willing to undergo a screening colonoscopy within six months of enrollment.
3. Subject is 45 to 80 years of age inclusive.
4. Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
5. Subject is able and willing to provide stool samples according to written instructions provided to them.

Exclusion Criteria:

1. Subject has any condition which, in the opinion of the investigator should preclude participation in the study.
2. Subject has a history of colorectal cancer or adenoma.
3. Subject has a history of other digestive tract cancer.
A Randomized Pilot/Pharmacodynamic/Genomic Study of Neoadjuvant Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer

This study is a randomized pilot/pharmacodynamic/genomic study of neoadjuvant paricalcitol to target the microenvironment in resectable pancreatic cancer to determine the effect of targeting the vitamin D metabolic program in the tumors of patients treated with one cycle of gemcitabine/abraxane with or without paricalcitol prior to surgery for resectable pancreatic cancer through an assessment of cellular and imaging markers.

This study is a randomized pilot/pharmacodynamic/genomic study of neoadjuvant paricalcitol to target the microenvironment in resectable pancreatic cancer to determine the effect of targeting the vitamin D metabolic program in the tumors of patients treated with one cycle of gemcitabine/abraxane with or without paricalcitol prior to surgery for resectable pancreatic cancer through an assessment of cellular and imaging markers.

Eligibility Criteria:
Inclusion Criteria

* Previously untreated, apparently resectable, adenocarcinoma of the pancreas at registration.
* Age greater than or equal to 18 years
* Eastern Cooperative Oncology Group performance status of 0-2.
* Standard laboratory criteria for hematologic, biochemical, and urinary indices within a range that, in the opinion of the physician, clinically supports enrollment of the patient on the trial. Note: subjects must have: Creatinine \< 2x Upper Normal Limit , Transaminases \< 3x Upper Normal Limit, Neutrophils \>1.5x109/L, and Platelets \>100,000/mm3
* Ability to provide written informed consent

Exclusion Criteria

* Patients with hypercalcemia (blood levels greater than 11.5 mg/dL; in patients with kidney disease, blood calcium levels must be 9.5 mg/dL or lower before starting paricalcitol).
* Patients who are currently pregnant, planning to become pregnant, or breast-feeding.
* Patients who, in the opinion of the physician, would not be clinically appropriate for receipt of the therapy regimen associated with participation
Coronary Artery Study in Pediatric Heart Transplantation

Transplant coronary artery disease (TCAD) is a significant cause of morbidity and mortality in pediatric heart transplantation (PHT). Understanding the pathophysiology and early detection along with attempted medical management are crucial in preventing advancement of the disease and retransplantation or mortality. Coronary angiogram, although routinely used is insensitive to detect early TCAD. Measurement of fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microvascular resistance (IMR) using a doppler pressure and flow intracoronary wire may be more sensitive in evaluating the integrity of coronary vasculature and thus detect pre clinical TCAD. To the best of the investigators knowledge, measurement of these parameters has not been previously reported in PHT.


Eligibility Criteria:
Inclusion Criteria:

* less than 21 years and above 7 years of age

Exclusion Criteria:

* clinically significant coronary artery disease on angiography and inability to undergo IVUS
Fluoride Bioavailability After Ingestion of Water or Foods Prepared With Fluoridated Water

The importance of fluoridated water to control caries is well recognized. Although the mode of action of fluoridated water is known (related to a slight increase in fluoride concentration in saliva/dental biofilm in individuals living in fluoridated areas), the kinetics of fluoride concentration in saliva after ingestion of food prepared with fluoridated water, either from fluoride remaining in the oral cavity after mastication, or from fluoride returning from salivary secretion is not known in details. Therefore, the aim of this study is to assess fluoride bioavailability after ingestion of food prepared with fluoridated water. The study will be in vivo, crossover and double blind, in which 12 adult volunteers will participate. In 4 experimental phases, volunteers will ingest: a. a typical Brazilian meal cooked with non-fluoridated water (\<0.1 ppm F); b. a typical Brazilian meal cooked with fluoridated water (1 ppm F); c. non fluoridated water (\<0.1 ppm F) and d. fluoridated water (1 ppm F). Immediately before and 5, 10, 15, 30, 45, 60, 120, 180 minutes after the ingestion, a blood sample will be collected by digital puncture, and a sample of unstimulated saliva will be collected. Fluoride concentration in the samples will be determined by an ion specific electrode adapted for microanalysis. Results will be analyzed by ANOVA, with significance limit of 5%.


Eligibility Criteria:
Inclusion criteria:

* Good general health
* Good oral health
* Normal salivary flow rate

Exclusion criteria:

* Gastric disorders
* Renal disorders
* Systemic diseases
* Use of drugs that alter salivary flow rate/renal excretion
The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism

The aim of this study is to investigate which method of naltrexone induction during rapid opioid detoxification causes stronger stress response and has a higher influence on opioid abstinence caused by opioid induction.

Study enrolls opiate addicted patients who are motivated for a long term treatment and full opiate abstinence. Patient is offered to take part in a study. Information is provided regarding protocol, aim and course of study. Patients who are eligible and consent for study commit to follow the pre-study recommendations.

Study consists of:

Primary assessment - information about study. Assessment of patient according to predefined criteria. Consent form. Allocation of the treatment date.

Stabilization - Buprenorphine. Assessment according to SOWS and OWS. Total amount of buprenorphine is recorded.

Repeated evaluation - patient after successful stabilization course undergoes urine test for psychotropic substances, blood alcohol level is recorded. If any test is positive patient is not enrolled to study.

Correction of opioid withdrawal symptoms - all of the patients receive medicines for opioid detoxification, infusion therapy in predefined doses.

Antagonist induction - patients receive opioid antagonist (incremental or standard dose). Withdrawal symptoms are assessed and correction with lorazepam is given if needed.

Data collection - data is recorded (demographic, epidemiological, vital signs, opioid withdrawal symptoms, levels of hormones, metabolites, electrolytes).

Eligibility Criteria:
Inclusion Criteria:

* Opiate addiction
* Use of short-acting opiate (morphine or heroine)
* Age \> 18 years
* Length of opiate addiction \> 1 year
* Patient can make a decision for detoxification and has a capacity to consent for procedure
* Written consent for procedure

Exclusion Criteria:

* Polyvalent addiction
* Pregnancy or breast feeding
* Cardiovascular pathology
* Acute or chronic kidney disease
* Decompensated liver pathology (jaundice, ascites, hepatic encephalopathy)
* Infective complications of opiate addiction (pneumonia, phlegmon, abscess, thombophlebitis, sepsis)
* Malnutrition (Nutritional risk screening 2002 score ≥3)
* Diabetes mellitus
* Previous history of psychosis
* Glasgow coma scale \< 15
* Abdominal surgical intervention during last 30 days
* Cumulative buprenorphine dose for stabilization \< 8 mg
* Positive test for psychoactive substances during treatment
* Refusal to participate in study at any point of it
Two Approaches to Routine HIV Testing in a Hospital Emergency Department

This study was initially designed to compare the effectiveness of two different approaches to providing routine HIV counseling, testing, and referral services in an urban hospital emergency department setting. The initial phase was closed in July 2008. The second phase of this trial consists of establishing the differences in acceptability of HIV testing based on the method of testing offered (rapid oral fluid vs. fingerstick).

About 25% of HIV infected people do not know that they are infected. These people lack medical care that could prolong their lives and access to counseling services that could prevent further spread of HIV. With so many people unaware of their HIV status, there is a clear need for more readily available HIV counseling, testing, and referral services throughout the United States. The Centers for Disease Control and Prevention (CDC) recommends routine HIV testing in U.S. hospitals in which HIV infected patients make up at least 1% of the total patient population for that hospital. In the original proposal, we chose oral rapid HIV testing as we felt that this technique is noninvasive, acceptable to both patients and health care workers (without body fluid risk), and would maximize rates of HIV testing. This study directly compares acceptance rates of HIV testing as a function of the test type offered (oral vs. fingerstick) in a randomized controlled fashion.

Participants in this study will include adults who visit Brigham and Women's Hospital emergency department in Boston, Massachusetts. Participants will be randomly assigned to oral vs. fingerstick HIV testing by a designated HIV counselor and to fill out a questionnaire while waiting in the emergency room. The questionnaire will be anonymous. Participants will then be offered a rapid HIV test. Test results will be available in about 20 minutes and will be provided to participants by the HIV counselor. Participants who test positive for HIV will be offered a more definitive blood test to confirm HIV infection. The blood test results will be available 2 weeks from testing, and participants must return to the hospital to get their test results. Participants who test positive for HIV will be offered counseling support and referral services by either their assigned HIV counselor or emergency department staff member. Follow-up care appointments will also be initiated at this time. For participants who test positive for HIV, the study will last about 6 months. There will be no follow-up visits for participants who do not test positive for HIV during their emergency room visit.

Eligibility Criteria:
Inclusion Criteria:

* Waiting to receive care in the Brigham and Women's Hospital emergency room
* English- or Spanish-speaking
* Enters the emergency room when an HIV counselor is available

Exclusion Criteria:

* An estimated severity index score of 1 or 2 who have mechanical ventilation or are not deemed alert, awake, and oriented to person, place and time by the triage nurse
* HIV infected
Functional Outcomes of Voice Recognition Prosthesis

The purpose of this study is to evaluate the use of a voice activated prosthesis interface controller for functional outcomes as compared to standard prosthesis control.

The study will take place over two separate visits spaced about 1 week apart.

During the first visit participants will undergo informed consent. They will then be randomly assigned one of two test conditions, (a) standard control, or (b) voice recognition control.

For both conditions participants will be allowed to train on the control scheme until they are comfortable with it's usage. Subjects will then be asked to manipulate common objects as a test of improved control and utility. Functional outcome measures will be utilized to standardize the tasks performed and evaluate the advantages of voice control.

On the second visit participants will be assigned the alternate condition, allowed to train with the control scheme, and run through the same set of functional outcomes measures.

Upon completion of the second visit participants will be asked to fill out a questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years or older
* Be willing and able to complete the tasks outlined in the study
* Are at least 6 months post amputation
* Have used an upper limb myo-prosthesis
* Necessary prosthesis components to interface to the proposed device
* Have no injury to the residual limb or shoulder that will impact their participation in this study
* Must be current users of upper limb myo-prosthesis or able to wear a prosthesis simulator brace
* Users who utilize multi-articulating hand terminal devices, and specifically Touch Bionics iLimb or Steeper beBionic hand users will be preferred, as these are the targeted devices that will be used during testing.
* Subjects must also be able to speak English in order to be properly consented as well as to interface with the voice recognition module (only English will be included in this feasibility study).

Exclusion Criteria:

* The risks to pregnant people and fetuses are unknown and therefore pregnant people should not participate in the study and will be screened by self-disclosure.