cyrilzakka/clinical-trials huggingface dataset:
Neurobiological Basis of Response to Vyvanse in Adults With ADHD: an fMRI Study of Brain Activation

The purpose of this study is to determine the effects of Vyvanse, an FDA approved medication used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD), on brain activity in adults with attention-deficit hyperactivity disorder (ADHD). Participants may qualify for participation in this study because they have ADHD and are willing to participate in two Functional Magnetic Resonance Imaging (fMRI) scans and receive Vyvanse for treatment of their symptoms. Another purpose of this study is to collect and bank samples of blood for research to examine how genes influence brain activation seen during the brain scans. The study also seeks to find out whether certain genes are related to ADHD. Participants' entire genetic makeup will not be determined from this sample.


Eligibility Criteria:
Inclusion Criteria:

* Primary DSM-IV-TR diagnosis of adult ADHD (inattentive, hyperactive-impulsive or combined subtype), established via the ACDS v1.2.
* Must be between 18-55 years, inclusive.
* Provides written informed consent.

Exclusion Criteria:

* Lifetime or current diagnosis of bipolar disorder, schizophrenia or schizoaffective disorder.
* Current diagnosis of comorbid major depressive disorder, anxiety disorder or dysthymia or any controlled (i.e. requires pharmacological treatment) comorbid diagnosis. Participants with uncontrolled depressive or anxiety disorders may participate if, in the opinion of the Principal Investigator, the disorder will not confound the results of efficacy or safety assessments, increase risk to the participant or lead to difficulty complying with the protocol.
* Meets current DSM-IV-TR criteria for alcohol or any non-alcohol substance abuse or dependence disorder.
* Have organic brain disease (such as dementia) or traumatic brain injury residua. Have a history of seizure disorder (other than febrile seizures) or participants who have taken (or are currently taking) anticonvulsants for seizure control.
* Females who are currently pregnant or breast feeding, and women of child-bearing potential who are not currently using an adequate form of birth control.
* Participants with clinically significant abnormalities in ECG results that are deemed exclusionary in the opinion of the Principal Investigator will not be allowed in the trial.
* Participants who work the night shift or another schedule that would preclude beginning the daily dose of study medication in the morning.
* Participants with a positive urine drug result at Screening.
* Medical conditions limiting participation in the study.
* Documented history of intolerance or non-responsivity to methylphenidate or amphetamines.
* Have a medical condition that would, in the opinion of the study physician, make participation medically hazardous.
* ADHD, Not Otherwise Specified
* History of surgery involving metal implants, metal fragments in the eyes, braces, or a pacemaker.
Dose Finding Study for Combination of Capecitabine, Lapatinib and Vinorelbine in Metastatic Breast Cancer

The purpose of the study is to investigate safety and efficiency of the triple combination of capecitabine, lapatinib and vinorelbine in patients with metastatic breast cancer.

The combination of lapatinib with capecitabine ist a standard therapy für Her2 positive metastatic breast cancer. This study combines this therapy with the additional antimitotic mode of function by vinorelbine.

Eligibility Criteria:
Key Inclusion Criteria:

* Written informed consent
* Able to comply with the protocol
* ECOG performance status 0-1
* Adequate contraception
* Confirmed Her2/neu-positive, adenocarcinoma of the breast
* At least one measurable lesion according to RECIST 1.1 criteria
* First or second chemotherapy after diagnosis of metastasis
* Lapatinib treatment indicated (adjuvant trastuzumab treatment \<12 months ago or progressive disease with trastuzumab treatment)
* No signs and symptoms of CHF (chronic heart failure), LVEF (left ventricular ejection fraction) at study start at least 55%
* Adequate hepatic and renal function value
* Adequate hematologic function values

Exclusion Criteria:

* Pregnant or lactating women
* Concurrent participation in another clinical trial. Prior participation is allowed if the last study medication was administered more than 4 weeks prior to randomization
* Asymptomatic with regards to tumor illness
* Previous treatment with lapatinib, capecitabine or vinorelbine
* Necessity of planned treatment with other chemotherapeutics oder anti-hormone therapy
* Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study
* Evidence of cardiovascular disease, e.g. myocardial infection, unstable angina pectoris or arrhythmia
* History of vascular or cardiovascular disease within the past 6 months
* All illnesses that result in malabsorption of oral medication or inability to take oral medication
* Concurrent treatment with anti-viral drugs based on sorivudine or with aminoglycosides
* Concurrent treatment with any drug interfering with study medication, especially, those that induce CYP3A
* Concurrent treatment with allopurinol
* Other malignancies (except for basal cell carcinoma of the skin and cervical carcinoma in situ); patient can be included in the study if no recurrent disease has been observed for at least 5 years
* Concurrent illnesses or other circumstances that could interfere with trial participation, efficacy or safety of the patient
Measuring Surgical Recovery After Radical Cystectomy

The intent of this study is to establish a registry of post-surgical outcomes in patients undergoing radical cystectomy at MD Anderson Cancer Center and the collaborating institutions. The goals of this initiative are to obtain a detailed baseline of multiple patient-reported outcomes (PRO) and clinician-reported outcomes (CRO) as well as various presenting conditions associated with them, so that future quality improvement interventions can be evaluated accurately as to their relative contribution to improved outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Bladder cancer patients undergoing radical cystectomy at the MD Anderson Cancer Center and the collaborating centers.

Exclusion Criteria:

N/A
Searching for the Perfect Oil to Protect the Perineum: A Randomized-Controlled, Double-Blind Trial

In this study we intend to randomly assign each parturient one of two commonly used oils to be applied during the second stage of labor, one of them containing vitamin E. We will verify if perineal massage increases the chances of delivering with an intact perineum comparing the two oils. As secondary objectives, we will evaluate the effects of perineal massage on specific tear location, the severity of perineal tears and the amount of suture material required for repair.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Term pregnancy

Exclusion Criteria:

* Non-vertex pregnancies
* Multiple pregnancies
* Placenta previa
* Placental abruption
* Intra-uterine infection
* Non progressive labor first stage
* Former operations or surgical procedures in the vagina
* Perineal massage during the weeks before labor
Behavioral Activation for Treatment of Depression in Adolescents With Autism

In this study, the investigators will examine the feasibility, acceptability, and preliminary efficacy of a novel, behavior-based approach for treatment of depression symptoms in adolescents with autism spectrum disorder or ASD (i.e., Behavioral Activation for Adolescents with ASD, BA-A).

In this study, the investigators will examine the feasibility, acceptability, and preliminary efficacy of a novel, behavior-based approach for treatment of depression symptoms in adolescents with ASD (i.e., Behavioral Activation for Adolescents with ASD, BA-A). BA-A is a 12-session manualized treatment that utilizes established behavioral activation strategies and incorporates common mental health treatment adaptations for young people with ASD. For this project, the investigators will pilot BA-A with 23 adolescents (12-17 years of age) with ASD and clinically significant depression symptoms. To investigate BA-A feasibility, the investigators will examine treatment session attendance and therapist treatment fidelity. To investigate BA-A acceptability, the investigators will utilize a mixed methods approach, inclusive of surveys and qualitative interviews, to inform BA-A protocol refinement. To investigate BA-A preliminary efficacy, the investigators will examine depression symptoms, as well as secondary outcome measures, at pre-treatment, post-treatment, and one-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of ASD by a qualified health care provider
* Children's Depression Inventory, Second Edition (CDI2) parent-report and/or self-report T- score ≥ 65
* Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II) Full Scale IQ, Two-Subtest Form (FSIQ-2) ≥ 85
* Participation of a parent or legal guardian living in the same home who can read and write in English at or above the fifth grade level
* Teens must have been on a stable dose of medications for mood, anxiety, or behavior for at least three months prior to enrollment and have no planned medication changes during study period
* Not actively participating in another psychotherapy during study period

Exclusion Criteria:

* High suicide risk
* Physical aggression
* Psychotic and/or manic symptoms
IV SafeLock Device Functionality in Emergency Department

The purpose of this research study is to evaluate the functionality of the IV SafeLock in the clinical emergency department setting.


Eligibility Criteria:
Inclusion Criteria:

* Emergency Department nurses who are consenting and willing to perform tasks.
* Their patient population will include stable patients 18 or over, who present through triage, are medically stable, are able to verbally consent and require intravenous access.

Exclusion Criteria:

* Emergency Department nurses who are unwilling to consent to use IV SafeLock on their patient population.
* The patient population will exclude pregnant patients, children, prisoners, patients with dementia, or any member of protected class as specified by IRB.
* The patients must be medically stable and not include patients presenting with acute stroke, acute myocardial infarction, severe sepsis or shock.
Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia

The purpose of the study is to assess the effectiveness and safety of a new device called an Intramural Needle Ablation Catheter (INA catheter). The INA catheter is used for locating and ablating ventricular arrhythmias that have failed standard radiofrequency ablation. This approach is desirable because some people have ventricular arrhythmias that originate deep within the heart muscle where it is not abolished by ablation with standard catheters.

The investigators seek to determine whether the INA catheter can potentially help people who have ventricular arrhythmias that have failed standard radiofrequency ablation. The investigators also want to determine if it is likely to be safe, without excessive side effects.


Eligibility Criteria:
Inclusion Criteria:

Monomorphic ventricular tachycardia (VT) or incessant ventricular arrhythmia (defined as \>20% of beats due to ventricular arrhythmia including unifocal premature ventricular contractions (PVCs ), couplets, nonsustained VT) that is causing a decline in left ventricular (LV) ejection fraction to less than 0.50.

Arrhythmia meets the following criteria:

1. Ventricular arrhythmia is recurrent and symptomatic
2. prior antiarrhythmic drug therapy has failed due to recurrent ventricular arrhythmia, toxicity, or intolerance

   * Age 18 or older
   * Left ventricular (LV) ejection fraction \> 0.10 as estimated by echocardiography or contrast ventriculography within the previous 90 days
   * Failed prior VT or PVC ablation due to spontaneous recurrence of the arrhythmia or frequent PVCs.
   * Able and willing to comply with all pre-, post-, and follow-up testing and requirements
   * Signed Informed Consent

Exclusion Criteria:

* Patients with idiopathic VT defined as VT that originates from a region without evidence of scar detected by MRI or voltage mapping in a patient without other evidence of heart disease that is not causing significant depression of ventricular function.
* Definite protruding left ventricular thrombus on pre-ablation echocardiography when LV ablation is required.
* Thrombotic myocardial infarction within the preceding two (2) months.
* Other disease process that is likely to limit survival to less than 12 months.
* Class IV heart failure, unless heart failure is due to frequent or incessant VT.
* Contraindication to heparin.
* Allergy to radiographic contrast dye.
* Severe aortic stenosis
* Severe mitral regurgitation with a flail mitral valve leaflet.
* Significant congenital anomaly or medical problem that in the opinion of the principal investigator would preclude enrollment into the study.
* Enrolled in another investigational study evaluating a drug or device.
* Unstable angina that is not due to frequent or incessant VT.
* Women who are pregnant.
* Thrombocytopenia (platelet count \< 50,000) or coagulopathy.
* Acute non-cardiovascular illness or systemic infection.
* Cardiogenic shock unless it is due to incessant VT
Phase II Study to Evaluate Modified Folfirinox and Stereotactic Body Radiation Therapy in Non-metastatic Unresectable Pancreatic Adenocarcinoma

The purpose of this study is to evaluate the efficacy of modified FOLFIRINOX followed by stereotactic body radiotherapy (SBRT) in patients with borderline resectable pancreatic cancer (BRPC) and locally advanced pancreatic cancer (LAPC). The primary hypothesis will be to determine if modified FOLFIRINOX followed by SBRT improves progression free survival (PFS) compared to historical controls treated with gemcitabine-based chemotherapy with or without standard fractionated radiation.

The Primary and Secondary are listed below.

Primary Objective:

- To evaluate progression free survival after modified FOLFIRINOX and SBRT in borderline resectable and locally advanced pancreatic cancer.

Secondary Objective:

* To evaluate the radiographic response to FOLFIRINOX and SBRT by comparing IV contrast CT scans before and after therapy.
* To determine rates of recurrence (local only, systemic only, and both local and systemic), and overall survival.
* To determine rates of grade 3 or greater gastrointestinal toxicity, including acute toxicities occurring within 3 months of treatment, and late toxicities occurring over 3 months after completion of radiation.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed pancreatic adenocarcinoma
* Borderline resectable pancreatic adenocarcinoma or locally advanced pancreatic adenocarcinoma
* No evidence of extrapancreatic disease on diagnostic imaging
* No evidence of invasion into the duodenum or stomach, as determined by EGD/EUS
* No prior treatment (chemotherapy, biological therapy, or radiotherapy) for pancreatic cancer
* No prior treatment with oxaliplatin, irinotecan, fluorouracil, or capecitabine
* ECOG Performance Status of 0-1
* No other malignancy within past five years (exceptions include basal cell carcinoma of the skin, cervical carcinoma in situ, and non-metastatic prostate cancer)
* No evidence of second malignancy at the time of study entry
* No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
* No \> grade 2 sensory peripheral neuropathy
* No uncontrolled seizure disorder, active neurological disease, or known CNS disease
* No significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment
* Not pregnant and not nursing
* No other medical condition or reason that, in the opinion of the investigator, would preclude study participation
* Laboratory parameters as follows:

  * Absolute neutrophil count ≥1,500/uL,
  * Platelet count ≥75,000/uL,
  * Hemoglobin ≥9 g,/dL,
  * Creatinine \<1.5 X ULN or estimated GFR \>30 ml/min,
  * Bilirubin \<1.5 X ULN,
  * AST and ALT \<3 X ULN,
  * Negative pregnancy test in women of childbearing potential
* Able to be treated with SBRT only at the Smilow New Haven campus
* Able to have fiducials placed in the pancreas

Exclusion Criteria:

* Failing to meet any of the Inclusion Criteria
Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer

RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment against skin cancer.

PURPOSE: This phase II trial is studying the side effects of photodynamic therapy using aminolevulinic acid and to see how well it works in treating patients with skin cancer.

OBJECTIVES:

* To determine the safety and efficacy of intralesional photodynamic therapy using aminolevulinic acid and non-coherent blue light in patients with nodular basal cell carcinoma.

OUTLINE: Patients undergo photodynamic therapy comprising intralesional injection of aminolevulinic acid followed by non-coherent blue light therapy over approximately 17 minutes. Patients may undergo re-treatment with photodynamic therapy 8 weeks later.

Patients undergo photographic assessment of their skin lesions at baseline, 8 weeks, 16 weeks, and then at 1 and 2 years to evaluate healing time, clinical improvement, and side effects.

Patients undergo biopsies of their skin lesions at 16 weeks and then at 1 and 2 years to confirm histological clearance.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Biopsy-proven basal cell carcinoma on the trunk or extremities

  * Tumor size ≤ 2 cm in diameter

PATIENT CHARACTERISTICS:

* Willing and able to comply with all follow-up requirements
* Mentally competent
* No active, localized, or systemic infections
* Not immunocompromised
* No coagulation disorder
* No photosensitivity or allergy to sunlight
* Not pregnant or nursing
* No history of keloid formation
* No history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins, or photodermatosis

PRIOR CONCURRENT THERAPY:

* No prior gold therapy
* No prior radiotherapy to the trunk and extremities
* More than 24 months since prior oral retinoids (e.g., isotretinoin or acitretin) or photosensitizing drugs (e.g., Declomycin®)
* More than 1 year since prior collagen or other injections, Botox® injections, chemical peels, dermabrasion, or resurfacing procedures
* More than 1 month since prior topical retinoid therapy
* No concurrent aspirin or antioxidants
* No concurrent anticoagulation medications
Functional Magnetic Micturition in Patients w/SCI

This project will determine the ultimate usefulness of functional magnetic stimulation (FMS) as an assistive device for voiding in patients with SCI.

Investigators intend to determine the ultimate usefulness of functional magnetic stimulation (FMS) as an assistive device for voiding in patients with SCI.

Thirty six persons will be recruited and will undergo an 8 week protocol for conditioning of the bladder. The investigators propose to: investigate the changes in bladder function in response to long-term bladder conditioning by FMS; further optimize the FMS technology and parameters for effective bladder emptying in SCI; evaluate the role of the external sphincter muscle fatigue by FS in facilitating bladder emptying; critically evaluate the relative response of FMS data to existing information using functional electrical stimulation;further develop criteria that will be used to predict which SCI patients are optimally suitable for FMS; establish a comprehensive stimulation criteria that will reflect the safety and effectiveness of structures associated with the bladder that are exposed to the electro-myographic field.

Eligibility Criteria:
Patients with SCI above T10 level, six months post injury
Registry for Mayo Clinic Adult Congenital Heart Disease Control Population

This research study is being done to provide comparative data to the Mayo Clinic Adult Congenital Heart Disease Registry.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≤ 30.
* No current cardiac medications.
* Systolic BP ≤ 140 mmHg.
* Diastolic BP ≤ 90 mmHg.
* Capacity to consent.

Exclusion Criteria:

* To be assessed via EMR screening.
* Patient confirmation during screening visit.
* Screening tests as applicable.
* History of cardiovascular disease. eGFR \< 30.
* Current orthopedic limitations.
Urdu Version Of Modified Oswestry Low Back Pain Scale; A Reliability And Validity Study

The ultimate goal of this study is to interpret Modified Oswestry Low Back Pain Scale into Urdu and analyse its reliability and validity in the population of Pakistan lumber radiculopathy patients. Examine its correlation with Quebec back pain disability scale and the visual analogue scale, as well as the Roland-Morris disability questionnaire.

As per preceding commendation, Modified Oswestry Low Back Pain Scale will be translated into Urdu language from its English version and adapted culturally in Pakistan. 100 individuals will be selected on the basis of convenience sampling with clinical characteristics. The patient will answer the questionnaire package that included the Urdu version Modified Oswestry Low Back Pain Scale, Quebec back pain disability scale, Roland-Morris disability questionnaire and Visual analogue scale on the same day, with a 30-minute delay between the first and second application. Observer-1 will be conducting a third assessment after 7 days for intra-observer evaluation. Statistical Package of Social Sciences Version 24 will be used to enter and evaluate the data. Internal consistency will be measured using the Cronbach alpha value. To evaluated test-retest reliability, an intraclass correlation coefficient will be employed. The Modified Oswestry Low Back Pain Scale will be evaluated for content validity, construct validity, criterion validity, and responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* Both genders, between the ages of 18 to 65,
* Individuals who could read and speak Urdu as a first language
* People who have been diagnosed with lumbar radiculopathy by a physician or neurosurgeon,
* Low Back Pain in the lower extremities with or without radicular pain.

Exclusion Criteria:

* Female patients who were pregnant
* Patients with a mental health history, cancer, or neurological problems
* Acute low back pain is a frequent disease (included recent thoraco-lumbar trauma),
* Psychiatric and behavior issues, systemic disease (tumors and rheumatological diseases), and central or peripheral neurological problems
* Patients who had recently had a cerebrovascular accident or a myocardial infarction were also ruled out.