cyrilzakka/clinical-trials huggingface dataset:
Advanced Perfusion MRI of Treatment Response and Progression in Glioblastoma

The primary aim of this project is to Compare new msCS and standard DSC-PWI methods in GBM patients undergoing post-operative MRI for monitoring of tumor progression.

Investigators will compare the novel to the standard DSC-PWI methods in twenty five GBM patients to determine whether novel method improves image quality in tumor regions. We will also compare accuracy of pseudoprogression (PsP) vs. early progressive disease (ePD) determinations by the two techniques. If successful, the project will culminate in a novel imaging method sequence optimized to monitor progression and guide treatment decisions in post-operative GBM patients.

Eligibility Criteria:
Inclusion Criteria:

* Histology: Glioblastoma (grade 4 astrocytoma)
* Standard-of-care, post-gd T1w image changes suggestive or consistent with of progression.
* Standard-of-care MRI included conventional DSC-PWI without unexpected technical difficulties.
* Methylation status of tumor available in medical record.
* Able to provide written informed consent.

Exclusion Criteria:

* Contraindications either to 3T MRI (e.g. certain metallic and electronic implants, claustrophobia) or IV gadolinium contrast (allergy, pregnancy, breast-feeding, renal insufficiency). Screening for these contraindications will be based on history only (as it is for all routine outpatient clinical MRI at UWHC).
* Significant physical or mental disease which would preclude successful compliance and participation in the study or, in the opinion of the principal investigator, or co-investigator, constitute a hazard, such that enrollment in the study would not be in the patient's best interest.
* Special subjects such as minors, mentally disabled persons, or prisoners.
FOCUS:Focus On Coronary Unstable Syndromes

Study objectives:

* To demonstrate that the acute administration of ramipril will control the inflammation process in patients with high-risk Acute Coronary Syndrome (ACS) as assessed by the high sensitivity C-reactive protein blood levels.
* To demonstrate that the normalization of blood glucose levels with intravenous insulin will improve the inflammation process during the acute phase of an ACS as assessed by Tumor necrosis factor alpha blood levels.


Eligibility Criteria:
Inclusion Criteria:

* Subject either not of childbearing potential or is not pregnant and agrees to use contraceptive measure for the duration of the study
* Subjects presenting within 12 hours after the last episode of chest pain with:

  * An accelerating pattern of anginal pain
  * A prolonged or recurrent anginal pain at rest or with minimal effort AND
  * Evidence of myocardial ischemia on ECG manifested by at least one of the following ECG criteria: - new persistent or transient ST-segment depression OR transient or reversible ST-segment elevation or new persistent or transient T-wave inversion OR Abnormal cardiac markers defined as: CK-MB greater than the upper limit of normal Troponin T or I level greater than the upper limit of normal.

Exclusion Criteria:

* Known or suspected pregnancy or actively breast-feeding
* Female of childbearing potential not using or planning to use a reliable method of contraception
* Treatment with Hormone Replacement Therapy at time of randomization
* Angina precipitated by obvious provoking factors
* Heart Failure defined as known ejection fraction less or equal to 40% or NYHA (New York Heart Association) class III pr IV
* Type I Diabetes Mellitus
* Type II diabetes requiring insulin therapy
* Hyperkaliemia
* Acute chronic inflammatory, collagen tissue disease, auto-immune disease or cancer and/or requiring the use of anti-inflammatory or anti-neoplastic agents at the time of randomization
* Use of a non-steriodal anti-inflammatory agent, coxibs, or anti-neoplasic agent within last 7 days
* Use of any oral or intra-venous steroidal agent in the last 7 days before study entry
* Uncontrolled hypertension
* Systolic pressure \< 100 mmHg at randomization
* Likelihood of requiring treatment during the study period with drugs not permitted by the protocol
* Treatment with any investigational product or device in the last 4 weeks
* Previous participation into the trial
* History of hypersensitivity, allergy, or intolerance to Angiotensin-Converting Enzyme inhibitors.
* Severe cardiovascular diseases requiring urgent therapy
* Severe or co-morbid condition
* History of cancer not known to be disease free, with the exception of basal cell carcinoma of the skin
* Clinically important systemic disorder
* Impaired hepatic function
* Clinically important chronic or acute renal failure
* History of drug or alcohol abuse
Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis

The efficacy of the topical anesthetics will be determined by how much pain the patient felt (using a Heft-Parker pain analog scale) upon needle penetration.

This project will be a double blind study comparing the efficacy of two different topical anesthetics used to reduce the pain associated with insertion of dental needles on the palatal mucosa. The two topical anesthetics being compared are 20% Benzocaine, and Pliaglis.

In order to complete a number of different dental procedures, it is often necessary to provide local anesthesia of the palate. Intraoral injections into the palatal mucosa are often uncomfortable and even painful. In an effort to increase patient comfort, a topical anesthetic is often used prior to the injection. Test subjects undergoing routine endodontic treatment on maxillary teeth will have a 27- gauge dental needle inserted into the mucosa of the hard palate as part of the initial step in standard local anesthetic injection. At the injection site and prior to the needle stick, the mucosa will be topically anesthetized by using one of the two different test compounds (Benzocaine or Pliaglis). After the injection, patients will be asked to score the level of discomfort associated with the needle stick.

The purpose of the project is to determine if there is a clinical difference in the level of pain felt upon needle stick, between the two different topical anesthetics.

Eligibility Criteria:
Inclusion Criteria:

* normal healthy adults 18+ yrs old requiring root canal treatment of maxillary molars
* Patients with healthy mucosal tissues, and who do not have pain on palpation at injection site
* Ability to use and understand a VAS score
* Ability to use and understand a VAS score
* No know allergies to topical anesthetics being used

Exclusion Criteria:

* Allergy or other contraindications to topical anesthetics
* Allergy to epinephrine or local anesthetics
* Broken/unhealthy mucosal tissues and pain on palpation at injection site
* Patients needing endodontic therapy on maxillary anterior teeth
* Inability to consent to participate in the study
* Patients who have used analgesics within 6 hours of appointment time
* Pregnant and nursing women
Diabetic Retinopathy and Subclinical Signs of Disease Transition

The prevalence of diabetes mellitus (DM) is increasing worldwide. Diabetic retinopathy is the most prevalent complication of DM and a leading cause of visual impairment. Some factors are known to temporarily aggravate or improve diabetic retinopathy, but underlying pathophysiologic factors are still unknown. High-resolution imaging techniques of the retina and its supplying vascular networks now allow novel insight to subtle changes that cannot be appreciated in standard fundus examination. In detail, the investigators image study patients with optical coherence tomography (OCT) - technology, that provides morphological information of retinal structure and the supplying vessels in a non-invasive way. Retinal layer thickness as well as capillary density will be quantified and followed in patients that are in a critical period of disease transition to better understand the process of diabetic retinopathy.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus type 1 or 2
* Age 18-90

Exclusion Criteria:

* Media opacities like cataract or vitreous hemorrhage
* Active intraocular inflammation (grade trace or above) in either eye like infectious conjunctivitis, keratitis, scleritis, endophthalmitis as well as idiopathic or autoimmune-associated uveitis in either eye
* Structural damage to the center of macula in the study eye
* Atrophy of retinal pigment epithelium, subretinal fibrosis, laser scar within foveal avascular zone (FAZ) or organized hard exudate plaques
* Ocular disorders in the study eye including retinal vascular occlusion, retinal detachment, macular hole, choroidal neovascularization, macula dystrophies
* Intraocular surgery (including cataract surgery, YAG laser capsulotomy) in the study eye within 3 months preceding Day 0, or history of corneal transplantation in the study eye
* Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication)or history of glaucoma filtration surgery
* Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded
Sustaining Recovery for People on Opioid Agonist Treatment With Conversational Agents

This study aims to improve retention in buprenorphine treatment, a medication used for opioid use disorder, through the use of a smartphone-delivered recovery support intervention. The intervention involves an Embodied Conversational Agent (ECA), a virtual, animated computer agent designed to simulate natural face-to-face conversations. ECAs have been shown to help individuals manage their healthcare in other settings, and this study seeks to evaluate their potential in supporting patients on medication for opioid use disorder (MOUD).

One hundred participants will be enrolled in the study from the Office-Based Addiction Treatment (OBAT) clinic at Boston Medical Center (BMC). The participants will be randomly assigned to one of two groups: 75 will receive the ECA intervention in addition to usual care, while 25 will receive treatment as usual. The ECA group will be further divided into three subgroups based on different engagement strategies: 1) technical support only, 2) technical support with additional messages from the ECA on behalf of OBAT clinic staff, and 3) the same as group 2, but with incentives if they log into the app for 15 days that month. The primary outcome is retention in buprenorphine treatment over 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Opioid Use Disorder (OUD)
* Within 14 days of intake at recruitment site (BMC OBAT) and 30 days of current buprenorphine treatment episode
* Possession of a smartphone that has minimum requirements
* English-speaking
* Willing to release electronic health record (EHR) data
* Able to provide at least two alternate contacts who usually know how to get in touch with them
* Able to provide informed consent and participate in this study

Exclusion Criteria:

* Treatment with sublingual buprenorphine in the 30 days prior to current treatment episode (56 days for long acting injectable buprenorphine), excluding bridge prescriptions of less than three days
* Incarceration anticipated within 12 months of enrollment
* Inability to comprehend the study protocol, defined as failing three times to answer correctly a set of questions during the consent process
* Inability to use the ECA app (i.e., due to markedly limited visual or auditory acuity or motor function required to interact with the ECA)
Connection to Care: Pilot Study of a Mobile Health Tool for Patients With Depression and Anxiety

This is a pilot feasibility study of a mobile health tool (smartphone app) for primary care patients receiving treatment for depression or anxiety delivered in an integrated primary care-based behavioral health program.

This research is a feasibility pilot study of a smartphone app using mixed methods. The research seeks to answer the question: "Is a mobile health tool for patient self-management feasible, useful, appropriate, and acceptable for patients and care managers for patients with depression or anxiety treated in an integrated primary-care based behavioral health program?"

Eligibility Criteria:
Inclusion Criteria:

* Be part of the Behavioral Health Integration Program for anxiety and/or depression; Must have an iPhone or Android smartphone with a mobile voice calling plan with a US carrier; Fluent in English

Exclusion Criteria:

* Individual unable or unwilling to accept the terms of the Ginger.io terms of Use; Actively suicidal as determined by a healthcare professional; score of 3 on the Patient Health Questionnaire-9 item 9 (which assesses thoughts of self-harm); or documented history of 2 or more prior suicide attempts; Working diagnosis of psychotic disorder, bipolar disorder, dementia, active substance dependence
PUVA Versus PUVA + IFN Alpha 2a in Mycosis Fungoides

The purpose of this study is to determine if combination of PUVA with interferon alpha is better than PUVA alone to treat mycosis fungoides stage Ia Ib or IIa.


Eligibility Criteria:
Inclusion Criteria:

* Mycosis fungoides Stage Ia Ib IIa
* Written informed consent
* 18-70 y.o., both sex
* No concomitant systemic disease

Exclusion Criteria:

* Pregnant or lactating women
* Fertile women not accepting contraception
* Medical history of melanoma or non melanoma skin cancer
* Concomitant infections
* Immunodeficiency states
* Previous Heart disease
* Respiratory insufficiency
* Chronic RRenal insufficiency
* Chronic hepatopathy
* Epilepsy
* Depression
* Leucocytes \<3000 or neutrophiles \<1000 or thrombocytes \<100000 or hemoglobin \<12 gr/dL or ANA \<1/80
* Treatment with systemic steroids
* Altered thyroid hormones
* Previous resistance to PUVA and/or IFN
* Hypersensitivity to IFN
* Patients under treatment with teophiline and/or dicumarol
* Previous total skin electron beam
* Wash up period less than 3 month for IFN and /or PUVA
* Wash up period less than 1 month for topical treatments
Sustainable Mindfulness and Resilience Training (SMART)

Investigators are proposing a 6-week mindfulness and resilience training intervention tailored for caregivers of children with autism. Investigators will assess increases the caregiver's well-being and levels of psychological acceptance of their life situation as it relates to their child with autism. The mindfulness training focuses on self-regulation of emotional responses and acceptance of internal experiences. Self-report measures and qualitative interviews will be administered at baseline and post-intervention. Investigators will compare the active group to a control group of caregivers who are on the waitlist to receive the intervention.

Investigators will prospectively examine a sample comprised of parental caregivers (ages 20 to 60) of children with autism spectrum disorder (ages 3 to 12) to determine how responses to the chronic stress of caregiving may contribute to psychological distress (e.g depression, caregiving burden, self-reported sleep).

All participants:

Participants will be randomized into the active group vs. wait list control group. Investigators will assess indices of psychological health at 2 time points over 6 weeks (length of intervention) - a Baseline Assessment, and a Follow-up Assessment. Both baseline and follow-up assessments include the same battery of questionnaires.

Daily/nightly diaries will also be completed by participants in the 7 days leading up to the baseline and follow-up time points.

In addition to self-report measures, investigators will conduct a 20-25 minute qualitative interview with caregivers both pre and post-intervention. The interview is optional and will be conducted via telephone before beginning the six-week course and within two weeks of finishing the course. The interview will be used to assess caregiver's acceptance of their child's condition and better understand their personal perception of their own acceptance. Interviews questions will be open-ended and may be modified based on the caregiver's response. An example question includes, "How hard has it been to accept your child has ASD?

Control group only:

The control group will be waitlisted and enrolled in the next 6-week mindfulness course. Investigators expect the next mindfulness course for the waitlist control group to be held within 1-3 months of the initial active group course.

Active group only:

The active group will participate in a mindfulness resilience training intervention. The intervention consists of weekly 2 hour classes held at UCSF Parnassus Campus over the course of 6 weeks. The study PI, Dr. Elissa Epel, will lead the intervention classes teaching the fundamentals of mindfulness training. The training focuses on acceptance and awareness of the present moment.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-60 years old
* Full time caregiver for a child with ASD, aged 3 to 12
* Child diagnosed with ASD for a minimum of 6 months
* English Speaking

Exclusion Criteria:

* Any conditions that may make it difficult to participate in a mindfulness group (e.g., psychotic disorder, personality disorder)
Phenazopyridine for Confirmation of Ureteral Patency

In this prospective, randomized trial subjects will be randomized to receive phenazopyridine or no medication prior to pelvic reconstructive procedures that use cystoscopy to confirm ureteral patency intraoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Females only
* Planned surgical procedure where cystoscopy will be used to document ureteral urine flow
* Age \> or = 18 years, no upper age limit
* Able and willing to consent

Exclusion Criteria:

* Planned surgical procedure where cystoscopy will not be used
* Planned surgical procedure where cystoscopy is used for a purpose other than documenting ureteral urine flow
* age \<18 years
* pregnancy
* unable/unwilling to participate
* history of allergy or adverse reaction to phenazopyridine
* hepatic dysfunction
* known phenazopyridine hypersensitivity
* history of urologic surgery
* presence of ureteral stents prior to the planned surgical procedure
* concomitant suprapubic catheter placement
Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis

Efficacy and safety study of bepotastine besilate ophthalmic solution in allergic conjunctivitis


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least 10 years of age

Exclusion Criteria:

* No active ocular disease
A Study to Assess Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization in Chinese Participants Receiving Upadacitinib for Atopic Dermatitis (AD) Through Chart Review

Atopic Dermatitis (AD) is a common, chronic, and flaring systemic inflammatory skin disorder characterized by intensely pruritic and distressing skin eruptions. This study will assess treatment patterns, treatment outcomes, healthcare resource utilization in Chinese participants receiving Upadacitinib for Atopic Dermatitis (AD) undergoing chart review.


Eligibility Criteria:
Inclusion Criteria:

* Participants with at least one primary diagnosis of atopic dermatitis with ICD-10 code of L20.900 \[atopic dermatitis, unspecified\] or physician-confirmed atopic dermatitis documentation within the study period
* Participants with at least one documented health record of upadacitinib prescription that has a primary diagnosis of atopic dermatitis within the study period
* Participants with at least one atopic dermatitis severity measures (i.e., EASI) in the follow-up period including up to 6 months after the index date

Exclusion Criteria:

• Participants who did not fulfill the inclusion criteria will be excluded
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children

The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will also assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site will be assessed during the study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children previously immunized with 1 or 2 doses of Prevenar.
* Group 1: Male or female subjects between the age of \>=140 and \<=196 days of age at time of enrollment.
* Group 2: Male or female subjects between the age of \>=336 and \<=392 days of age at time of enrollment
* Available for entire study period.

Exclusion Criteria:

* Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component.
* Previous vaccination with licensed or investigational pneumococcal vaccine other than Prevenar.
Aflibercept and Standard Chemotherapy (R-CHOP) in First Line of Non Hodgkin B-cell Lymphoma

The purpose of this study is to determine the selected dose of aflibercept when it is combined with R-CHOP treatment (Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone +/- intrathecal Methotrexate) administered every 2 weeks or every 3 weeks, in non Hodgkin B-cell lymphoma, and to determine how the body handles aflibercept when it is administered with R-CHOP.


Eligibility Criteria:
Inclusion Criteria:

* Patients with non-Hodgkin B-cell lymphoma, good condition, not previously treated

Exclusion Criteria:

* Contraindication to any drug contained in the R-CHOP (Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone +/- intrathecal Methotrexate)
* Less than 42 days elapsed from prior major surgery (28 days from other prior surgery) to the time of inclusion
* Cerebral or leptomeningeal involvement.
* History of another neoplasm (Adequately treated basal cell or squamous cell skin cancers, carcinoma in situ of the cervix, or any other cancer from which the patient has been disease free for \> 5 years are allowed)
* Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to the first drug intake
* Any acute or chronic medical condition, which could impair the ability of the patient to participate to the study or could interfere with interpretation of study results
* Uncontrolled diabetes mellitus
* Uncontrolled hypertension
* Abnormal kidney function
* Evidence of clinically significant bleeding diathesis, non-healing wound or underlying coagulopathy
* Pregnant or breast-feeding woman, or patient with reproductive potential (male, female) without an effective method of contraception
* History of hypersensitivity to any Trap agents or recombinant proteins