cyrilzakka/clinical-trials huggingface dataset:
Asthma Self-Management For Adolescents

The goal of this study is to help adolescents with asthma learn to control their illness and live without restrictions. We hypothesize that an intensive school-based asthma education program for students in 9th and 10th grade who have persistent asthma, together with asthma education for their primary care physicians, will improve the students' health status, quality of life, and ability to control their asthma through self-management.

Five public high schools from areas in New York City with high asthma rates will be enrolled in the study. In each school, we will identify students with asthma using a brief, self-administered survey that asks questions about current symptoms of wheeze, persistent cough, chest tightness, night waking, and past diagnosis of asthma. Eligible students will have the program explained to them individually. Caregivers of students who express interest in the program will be contacted to obtain written, informed consent. An equal number of students in each school will be randomly assigned to the immediate intervention group and to a control group that will receive the program 12 months later. Students assigned to the immediate intervention group will take part in three group workshops to learn about the chronic nature of asthma, how to control asthma by monitoring symptoms and using medicines consistently, and how to take preventive management steps using environmental control strategies and a written treatment plan from their physician as a guide for adjusting their medicines. They will also receive individual coaching by a health educator to assess how the students are doing and feeling, help them interpret their symptoms and responses to medication, and encourage them to take the next steps to control asthma. Before the visit we will have asthma specialist physicians on our staff make a telephone call to the student's physician to alert them that the student will make a visit, that the student will bring symptoms diaries, and to encourage the physician to review the diaries, prescribe according to NHLBI guidelines, and provide a written treatment plan. The intervention for each student will last three months. During the follow up year, no educational contact will be made with control group students, families, or physicians. Following completion of the study 12 months later, these students will be offered the same intervention provided to the immediate intervention group.

Eligibility Criteria:
Inclusion Criteria:

* 9th or 10th grade high school student
* diagnosed moderate to severe persistent asthma
* used physician prescribed asthma medicine in past 12 months

Exclusion Criteria:

* comorbidity with other diseases that affect lung function
* enrollment in special education classes for learning disabilities
Non-invasive Evaluation of Liver Fibrosis, Steatosis, and NASH in NAFLD

1. To evaluate hepatic fibrosis and steatosis using MR imaging, transient elastography (TE), and serum biomarker
2. To develop non-invasive diagnosis marker for NASH and advanced fibrosis

As nonalcoholic fatty liver disease (NAFLD) is becoming a leading cause of chronic liver disease, non-invasive diagnosis of disease severity in NAFLD is urgently needed. In this study, the investigators compared hepatic fibrosis and steatosis using MR imaging and transient elastography (TE) and tried to find non-invasive diagnostic marker for NASH and advanced fibrosis.

This is a multicenter prospective study of patients with biopsy-proven NAFLD. The patients were underwent laboratory test, liver biopsy, MRI and TE within 6 months of enrollment. MRI examination included MR spectroscopy (MRS), and MR elastography (MRE). TE measured liver stiffness and controlled attenuation parameter (CAP).

Eligibility Criteria:
Inclusion Criteria:

* Patients \>19 years age
* Patients who had elevated aspartate transaminase(AST)/alanine transaminase(ALT) or fatty liver on abdominal ultrasonography
* Patients who are clinically suspected to have nonalcoholic steatohepatitis(NASH): \>40 years age, BMI \>25, multiple features of the metabolic syndrome, presence of diabetes mellitus (DM) , fibroscan \> 6 kilopascal (kPa), platelet count \< 150,000 /ml, and other patients suspected to progress clinically or requiring diagnosis
* Patients who underwent (\<6 months) or will undergo US-guided liver biopsy

Exclusion Criteria:

* Chronic liver disease other than nonalcoholic fatty liver disease(NAFLD) (chronic hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis)
* Excessive alcohol consumption (weekly men \>140g and women \>70g)
* Fatty liver due to medication
* Decompensated liver cirrhosis
* Contraindication to magnetic resonance imager(MRI)
* Malignancy or other systemic disease
* Pregnancy
Trial of Ampakine Added to Clozapine, Olanzapine or Risperidone in Patients With Schizophrenia

The purpose of this study is to evaluate the effects of a four-week trial of CX516 900mg tid compared to placebo upon verbal memory, attention and negative symptoms. The AMPA receptor positive modulator, CX516, will be added to a stable dose of clozapine, olanzapine or risperidone in inpatients and outpatients with schizophrenia. The trial is intended to extend and replicate results from our previous placebo-controlled pilot trial of CX516 added to clozapine in which the investigators found improvement in memory and attention (moderate-to-large between group effect sizes) and did not observe serious side effects. Because the investigators' pilot trial also detected at two-week follow-up persistence of cognitive benefits and emergence of a large therapeutic effect upon negative symptoms, this trial will also repeat clinical and cognitive assessments at follow-up, four weeks after completion of the study medication to evaluate persistence and/or strengthening of effects.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Schizophrenia, any subtype
2. Ages 18-65 years
3. Capable of providing informed consent
4. Stable dose of clozapine, olanzapine or risperidone for at least 6 months

Exclusion Criteria:

1. Serious medical or neurological illness (unstable cardiac disease, seizure disorder, malignancy, liver or renal impairment, etc.)
2. Current substance abuse
3. Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile
4. Unable to complete neuropsychological tests
5. History of serious blood dyscrasia requiring discontinuation of clozapine
6. Serious suicidal or homicidal risk within the past six months
Using Acetylcysteine and Vitamin E With Psoriasis Vulgaris

This study aims to assess the effect of adding N-acetyl cysteine (NAC) alone or in combination with Vitamin E to conventional therapy in improving the clinical outcome, oxidative stress, and inflammation in patients with mild psoriasis vulgaris

The study will include 60 Mild psoriatic patients in the active phase (score \<, =3) using PASI score. The PASI is a widely used instrument that assesses and grades the severity of psoriatic lesions and the patient's response to treatment. They will assigned randomly into 3 groups. Each group will contain 20 patients. the first group will receive Standard treatment for mild psoriatic patients (topical steroid and salicylic acid), the second group will receive Standard treatment for mild psoriasis, plus N acetyl cysteine (600 mg a day) oral, 30 minutes before breakfast, for 8 weeks. the third group will receive Standard treatment for mild psoriasis, plus N acetyl cysteine (600 mg a day) oral effervescent sachet,30 minutes before breakfast Plus, vitamin E (1000 mg) daily, oral soft gelatin capsule for 8 weeks.

PASI=Psoriasis Area and Severity Index

Eligibility Criteria:
Inclusion Criteria:

1. Adult Patients from 18 to 65 years.
2. Gender: both males and females.
3. Mild psoriatic patients in the active phase (score \< =3)
4. Patients diagnosed with mild psoriasis in the active phase (score less than or equal 3) using PASI score.

Exclusion Criteria:

1. Inactive psoriasis vulgaris patients.
2. Alcohol consumption
3. Any other autoimmune diseases.
4. Pregnant or lactating women.
5. Patients with serious illness and any systemic failure (cardiovascular, renal, or respiratory)
6. Patients with major psychiatric or mental illness.
7. Intake of any antioxidants in the previous 3 months
8. Patients of chronic diseases, like hypertension, heart problems
9. Patients with history of bleeding, ulcers, or uncontrollable heartburn.
10. Patients taking anticancer medications that can aggravate psoriasis vulgaris such as mercaptopurine, vinblastine, actinomycin, and Radiation
The Effects of the Food Preservative Propionic Acid in Post-prandial Metabolism

Propionic acid (PA) is used as a preservative in foods such as cheeses, baked goods, or additive for artificial fruit flavors. The U.S. Environmental Protection Agency considers it safe and therefore, has no limitation on its use. Since PA has been shown before to serve as a substrate for glucose production in the liver, the purpose of this study is to find out if PA intake causes changes in levels of glucose, insulin and other important hormones following a meal.

This research study will compare PA to placebo. The placebo looks exactly like the active substance, but it does not contain any active agent (PA). Placebos are used in research studies to see if the results are due to the study drug or to other reasons.

The investigators plan to have 20 subjects take part in this study at the Brigham and Women's Hospital (BWH).

-To test whether PA, added as food supplement to humans, results in altered post-prandial metabolism. The investigators propose to conduct a double-blind, randomized, placebo controlled, cross-over study in which blood levels of metabolites and hormones will be measured in healthy volunteers following a mixed meal test without or with PA.

Study design:

This is a double-blind, randomized, placebo controlled, cross-over study. Twenty volunteers who meet the inclusion/exclusion criteria will be randomized into two groups, provided with a mixed meal without or with calcium proprionate (also known as E282). A week later, participants will be provided with a mixed meal again, following cross-over of the groups. Blood will be collected at baseline, and every 30 minutes for 4 hours.

Study Subjects:

20 healthy male and female volunteers (ages 18 to 65 years) with a body mass index (BMI) of 20 to \<30 Kg/m2.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Good health as evidenced by history and physical exam
* BMI: 20-29.9 kg/m2

Exclusion Criteria:

* Fasting plasma glucose \>110 mg/dL
* HbA1c \>6.0%
* Significant current illness other than treated hypothyroidism
* BP \>135/85 or systolic BP \<90 mm Hg
* Hepatic disease (transaminase \> 3 times normal)
* Renal impairment (Creatinine clearance \<60 ml/min)
* History of drug or alcohol abuse
* Participation in any other concurrent clinical trial
* Pregnant women
* History of food allergies.
Carotid Plaque Imaging Project (CPIP)

The rupture or erosion of an atherosclerotic plaque with thrombosis or embolization often underlie heart attacks and strokes. The early identification of patients with atherosclerotic plaques prone to rupture or erosions, vulnerable plaques (VP), and their treatment before the occurrence of events is, therefore, one of the greatest cardiovascular challenges today. Possible approaches for early detection of VP include imaging techniques allowing visualization of plaque structure, circulating biomarkers and better understanding of the pathophysiologic mechanisms of the disease. In the carotid plaque imaging project the investigators study human atherosclerotic plaques (that are removed by endarterectomy) to disclose their underlying structure and mechanisms, finding possible novel therapeutic targets or markers for VP. The investigators also study plaque structure with imaging methods and try to develop new ways to detect VP using circulating or imaging markers.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old, male or female that are eligible for carotid endarterectomy due to atherosclerosis and that can provide informed consent.

Exclusion Criteria:

* Patients younger than 18 years old that cannot provide informed consent; pregnant.
Evaluate Health Coaching Support in Technology-based Interventions for Meeting Health Goals

This was a pilot evaluation conducted to test procedures for a possible future trial and provide preliminary insights regarding whether text messages sent to Veterans could help support nutrition and/or physical activity health goals. For the purposes of the pilot, the goal was to enroll one participant.

The investigators prepared procedures for a one-group pilot intended to evaluate the delivery of automated text messages to Veterans. Completion of this pilot will provide preliminary insights regarding the delivering automated text messages focused on nutrition and/or physical activity health goals, and potential impacts on outcomes like self-efficacy, goal commitment, and health confidence.

Eligibility Criteria:
Inclusion Criteria:

* Patient at designated VA site
* Ownership of a cellular phone
* Over age 18
* Pre-screened by their primary care physician for study inclusion for medical contraindication to physical activity and diet change

Exclusion Criteria:

* Patient outside designated VA site
* Non-ownership of a cellular phone
* Under age 18
* Not pre-screened by their primary care physician for study inclusion for medical contraindication to physical activity and diet change or deemed ineligible to participate by primary care physician
Interstitial Brachytherapy Boost for Treatment of Anal Canal Cancers, Comparison of Two Dose Rates

Comparative retrospective study of two anal canal brachytherapy techniques aimed at boosting \[low dose rate (LDR) and high dose rate (HDR)\]

Efficacy of anal canal interstitial brachytherapy evaluated by local relapse rate, Tolerance of interstitial brachytherapy of the anal canal evaluated by the rate of chronic toxicities.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated by brachytherapy anal canal to boost.

Exclusion Criteria:

* Patients below age of 18 years
A Single Patient Compassionate Use of MBM-02 (Tempol) for the Treatment of Prostate Cancer

A single patient compassionate use clinical trial for the use of MBM-02 (TEMPOL) for the treatment of prostate cancer. The single patient will be exposed to orally administered TEMPOL for up to 12 months at a maximum total daily dose of 800mg.

Localized therapy for prostate cancer is often curative; however, 20% to 30% of patients experience a recurrence. Biochemical recurrence (BCR) occurs in an estimated 50,000 men/year in the U.S and is marked by a rising prostate specific antigen (PSA) after definitive radical prostatectomy and/or radiation therapy for localized disease.

Continuous androgen deprivation therapy (ADT), in which serum testosterone is decreased to a castrate level (less than 50 ng/dL) is a standard treatment in BCR. ADT is associated with significant short term and long term toxicities, including declining quality of life on treatment and increased risk of osteoporosis, diabetes, and cardiovascular disease. MBM-02 is being tested as a novel non-hormonal agent with improved biologic activity and better tolerability for use in biochemically recurrent prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Biochemical Recurrent Prostate Cancer

Exclusion Criteria:

-
Recurrent Stenoses in Arteriovenous Fistula (AVF) for Dialysis Access: CuttIng ballooN angioplaSTy Combined wITh Paclitaxel drUg coaTed Balloon Angioplasty, an observatIONal Clinical Study

To determine if cutting balloon angioplasty combined with DEB angioplasty provides a higher primary patency after treatment of recurrent stenoses compared with cutting balloon angioplasty or angioplasty using DEB alone in the venous outflow AVFs. For cutting balloon angioplasty in venous stenosis, the primary patency after 12 months is 55-60% (9,16) and in recurrent stenoses up to 48%(10).

We hypothesise that DEB angioplasty after cutting balloon angioplasty leads to improved primary patency at 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent stenoses (within 1 year after angioplasty) in the venous outflow of AVFs for dialysis access (\> 0.5cm from AV anastomosis up to cephalic arch)
* Successful guidewire crossing of target lesion
* ≥ 21 years old
* Informed and valid consent given.
* Patient willing and able to return for follow up .

Exclusion Criteria:

1. Thrombosed AVFs or occlusions in the access circuit
2. Significant cephalic arch (central perpendicular portion of the cephalic vein) or central vein stenoses.
3. \> 3 stenosed segments (lesions are considered separate if they are separated by at least 2 cm normal vessel.)
4. Only potential target lesion located in cephalic arch, central veins or anastomotic lesions.
5. Only de novo stenoses identifiable as target lesion.
6. Target lesion resistant to cutting balloon angioplasty (\>30% residual stenosis with incomplete effacement of the lesion during cutting balloon angioplasty)
7. Target lesion not treatable with the available sizes of cutting balloon (4-7mm) and drug eluting balloon (up to 8mm) so native reference vessel \<3 mm or need for DEB balloon \>8mm.
8. Lesion in excess of 8 cm
9. Unable to take dual antiplatelet therapy for 1 month and/or aspirin for 6 months
10. Coagulopathy (PT or PTT \>1.5 times the median of normal range) or thrombocytopenia (platelet count \<50,000 /μL) that cannot be managed adequately with periprocedural transfusion.
11. Patient on Warfarin.
12. Known allergy to iodinated contrast that cannot be managed adequately with pre-procedure medication.
13. Allergy / contraindication to dual anti-platelet therapy (aspirin and clopidogrel or ticlopidine) or paclitaxel.
14. Acute infection over proposed puncture site.
15. Women who are breastfeeding, pregnant or planning on becoming pregnant during study.
16. Participant with medical conditions, which in the opinion of the investigator may cause non-compliance with protocol.
17. Currently participating in an investigational drug, biologic or device trial that may have an impact on the dialysis access or previous enrolment in this study.
Algovita Spinal Cord Stimulation System Hi-Fi Study

The objective of this study is to obtain post-market clinical outcome data for the Algovita SCS System when used on-label, according to the applicable directions for use, using high fidelity tonic stimulation at either ultra-high pulse width or traditional pulse width for the treatment of persistent or recurrent back and/or leg pain following spinal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with FBSS defined as persistent or recurrent back and/or leg pain despite one or more anatomically successful back surgeries for the same original pain.
* Age 18-75 years old at consent.
* Targeted pain intensity of ≥ 5 out of 10 on the Baseline visit NRS.
* ODI score of 41-80 out of 100 at the Baseline visit.
* Appropriate candidate for the surgical procedure and Algovita SCS therapy based on the clinical judgment of the investigator and the Algovita Instructions for Provider (IFP) in the Nuvectra product manuals.
* On stable pain medications for at least 28 days prior to consent. Stable is defined as no new or discontinued pain medications and no changes to total daily dose of any pain medications.
* Willing and capable of providing informed consent.
* Willing and able of complying with the study-related requirements, procedures, and visits.
* Speaks English as a primary language (as the Algovita patient manuals are only currently available in English).
* Has adequate cognitive ability to use the subject devices (e.g., PPC, PoP), as determined by the investigator.

Exclusion Criteria:

* Has a medical/psychological/psychiatric condition/disorder that could interfere with study procedures as determined by the investigator.
* Has a coexisting pain condition that might confound pain ratings, as determined by the investigator.
* Has a condition currently requiring or likely to require the use of MRI or diathermy.
* Has an existing drug pump, SCS System, or other active implantable device.
* Has any prior SCS experience.
* Pregnant or planning to become (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years postmenopausal).
* For subjects with diabetes, HbA1c ≥ 8.5% as measured at the Baseline visit (or within the 3 months prior to the Baseline visit).
* Participating in another clinical trial that could affect the outcomes or requirements of this study as determined by the investigator.
* Involved in an injury claim under current litigation or have a pending or approved workers compensation claim.
Mometasone Furoate 0.1% Versus Eucerin on Moderate to Severe Skin Toxicities in Breast Cancer Patients Receiving Postmastectomy Radiation

The purpose of this study is to find out if the effect of mometasone furoate is any different from Eucerin in decreasing the severity of redness of the skin during irradiation, preventing the skin from peeling, or reducing the amount of irritation the patient reports during treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Stage 1-4 invasive breast cancer that is histologically confirmed at MSKCC
* Status post mastectomy with axillary exploration (sentinel node biopsy and/or axillary lymph node dissection) to receive PMRT
* ECOG Performance Status of 0 or 1

Exclusion Criteria:

* Male
* Patients with clinical evidence of gross disease
* Patients who are pregnant or breastfeeding
* Prior radiation therapy to the ipsilateral chest wall or thorax
* Patients requiring a chest wall boost
* Concurrent chemotherapy (biologic agents are allowed)
* Psychiatric illness that would prevent the patient from giving informed consent
* Inability or unwillingness to comply with skin care instructions and follow-up
* Allergy to either Eucerin or MF
* Residual grade \>1 skin toxicity, cellulitis, or incompletely healed wound(s) at intended site of study drug application at the time of the start of RT
* Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases)
* Treatment with palliative or pre-operative radiation