cyrilzakka/clinical-trials huggingface dataset:
Intraductal Papillary Mucinous Neoplasm With Malignant Change

Purpose:

To investigate diagnostic performance of CT and MR in intraductal papillary mucinous neoplasm with malignant change according to international consensus guidelines 2012.

Hypothesis: According to 2012 consensus guidelines, enhanced solid component and main pancreatic duct size of larger than 10 mm will be significant.

1. Purpose

   * To investigate diagnostic performance of CT and MR in intraductal papillary mucinous neoplasm with malignant change according to international consensus guidelines 2012
2. Enroll criteria

   * Patient who is suspected to have pancreas IPMN on imaging
   * Interval between imaging study and surgery is less than 2 months
   * Who is scheduled for surgery due to IPMN

Eligibility Criteria:
Inclusion Criteria:

* Patients who is suspected to have IPMN by imaging study or clinician
* Time interval between imaging study and surgery less than 2 months

Exclusion Criteria:

* Patients who have pathology results not by surgery
* Who is less than 20 years old
* Who cannot voluntarily agree study design
Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval and Pharmacokinetics in HER2-Expressing Breast Cancer

This study will look at the effect on the QTc interval and pharmacokinetics after multiple dosing in subjects with HER2-expressing metastatic and/or unresectable breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Has a pathologically documented unresectable or metastatic breast cancer with HER2 expression (immunohistochemistry \[IHC\] 3+, IHC 2+, IHC 1+ and/or in situ hybridization \[ISH\] +) that is refractory to or intolerable with standard treatment, or for which no standard treatment is available
* Has a left ventricular ejection fraction (LVEF) ≥ 50%
* Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1

Exclusion Criteria:

* Has a medical history of myocardial infarction within 6 months before enrollment
* Has a medical history of ventricular arrhythmias, other than rare occasional premature ventricular contractions
* Has uncontrolled or significant cardiovascular disease
CT Pancreas Perfusion

1. Pancreatic CT perfusion with a biofeedback breathing belt worn by the participant, and using novel post-processing techniques, is a reliable method which can be used to differentiate between pancreatic cancer, chronic pancreatitis, and autoimmune pancreatitis.
2. Pancreatic CT perfusion can be used to monitor patients undergoing decompression treatment (endoscopic retrograde cholangiopancreatography with stent placement) for painful chronic pancreatitis, and the change in the pancreatic perfusion parameters correlate with the change in the pain parameters (pain scale and analgesic use).
3. Pancreatic CT perfusion parameters can be calculated using surrogate scan data sets at specific time points to replace the continuous scanning.


Eligibility Criteria:
Inclusion Criteria:

1. a. Suspected pancreatic adenocarcinoma, age 35 to 99 years.
2. a. Chronic pancreatitis with chronic pain, age 18 to 99 years. Must be a confirmed diagnosis by either CT, endoscopic ultrasound (EUS), or endoscopic retrograde cholangiopancreatography (ERCP).

2b. To undergo endoscopic or surgical decompression with 0 to 10 days of first study visit CT perfusion scan.

2c. To answer pain questionnaire before first CT perfusion scan.

2d. To return within three weeks to three months after decompression treatment for another CT perfusion scan and complete the second pain questionnaire.

3a. Autoimmune pancreatitis, age 18 to 99 years either with diffuse or focal swelling of the pancreas confirmed by CT, MRI, or EUS or

3b. Irregular narrowing of the pancreatic duct on ERCP and either elevated serum immunoglobulin G4 (IgG4), or histological confirmation.

Exclusion Criteria:

1a. Pancreatic ductal adenocarcinoma tumors with vascular involvement but without vascular occlusion.

1. b. Pancreatic ductal adenocarcinoma tumors less than 2 cm in size.
2. a. Chronic pancreatitis with diffuse and extensive pancreatic calcification.
3. a. Autoimmune pancreatitis with a prior pancreas surgery or steroid treatment for autoimmune pancreatitis .

Any Cohort:

4. Pregnant.

5. Prior iodine contrast reactions.

6. Iodine allergy.

7. Decreased kidney function being a serum creatinine greater than 1.5mg/dl.

8. Any contraindication to having a CT scan with iodine contrast.
ImPACT Version 4-Touchscreen: Normative and Reliability Study

This research study is designed to establish normative database and reliability of ImPACT for adolescents and adults ages 12 through 80 to expand the use of devices to include touchscreen.

This research study is designed to establish normative database and reliability of ImPACT for adolescents and adults ages 12 through 80 to expand the use of devices to include touchscreen. Enrollment will be 900 participants.

Eligibility Criteria:
Inclusion Criteria:

1. Age 12-80
2. Primary English speaking or fluent in English

Exclusion Criteria:

1. Documentation of a known special education diagnosis other than a 504 designation.
2. History of concussion less than 6 months to the study participation
3. Known physical (e.g., visual impairment not fixable by usual means, such as glasses) or psychological impairment (ADHD, LDD, etc.) that would affect their ability to perform the test.
Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device (LVAD) and Medical Management

The purpose of this study is to evaluate and compare the effectiveness of the HeartMate II (HM II) Left Ventricular Assist Device (LVAD) support versus OMM in ambulatory NYHA Class IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and who meet the FDA approved indications for HM II LVAD destination therapy.

The HeartMate II (HM II) LVAD is approved by the U.S. Food and Drug Administration (FDA) for use in destination therapy (DT) patients with New York Heart Association (NYHA) Class IIIB/IV symptoms.

The ROADMAP trial is a prospective, multi-center, non-randomized, controlled, observational study that is designed to evaluate the effectiveness of HM II LVAD support versus optimal medical management (OMM) in ambulatory NYHA Class IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and who meet the FDA approved indications for HM II LVAD destination therapy. Subjects will be enrolled in one of two cohorts: OMM or LVAD. Together with the investigator, the subjects will decide which cohort to enter into at their baseline visit. This study will include experienced HM II LVAD implant centers as well as community centers that care for a large volume of heart failure patients. Study patients will be followed for up to 24 months post enrollment for survival, quality of life and functional status.

Eligibility Criteria:
The following are general criteria; more specific criteria are included in the study protocol:

Inclusion Criteria:

* NYHA Class IIIB/IV (refer to Appendix IV for definitions)
* Left ventricular ejection fraction (LVEF) ≤ 25%
* Not currently listed for heart transplantation, and not planned in next 12 months
* On optimal medical management
* Limited functional status as demonstrated by 6MWT \<300 meters
* At least:

  * One hospitalization for HF in last 12 months or
  * At least 2 unscheduled emergency room or infusion clinic visits (may include intravenous diuretic therapy, etc.) for HF in last 12 months

Exclusion Criteria:

* Presence of mechanical aortic or mitral valve, including planned conversion to bioprosthesis
* Platelet count \< 100,000/mi within 48 prior to enrollment
* Any inotrope use within 30 days prior to enrollment
* Inability to perform 6MWT for any reason
* Any condition, other than heart failure, that could limit survival to less than 2 years
* History of cardiac or other organ transplant
* Existence of any ongoing mechanical circulatory support (including intraaortic balloon pump, temporary circulatory support devices, etc.) at the time of enrollment
* Presence of active, uncontrolled, systemic infection
* History of an unresolved stroke within 90 days prior to enrollment, or a history of cerebral vascular disease with significant (\> 80%)extracranial stenosis
* Contraindication to anticoagulation/antiplatelet therapy
* CRT or CRT-D within 3 months prior to enrollment
* Coronary revascularization (e.g. CABG, PCI) within 3 months prior to enrollment
Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder

The purpose of this study is to determine whether treating sleep difficulties in patients with bipolar disorder also improves their mood stability.

Patients with euthymic bipolar disorder, although free of significant mood symptoms, often have continued sleep disturbances. Improving patients' sleep by also normalizing the circadian rhythm will lead to fewer mood exacerbations. Ramelteon offers a new and more pharmacologically exact mechanism to re-synchronize the SCN. The administration of ramelteon for bipolar patients will improve sleep and will cause fewer mood exacerbations.

Patients with bipolar disorder often experience frequent mood alterations that are attempted to be controlled by mood stabilizing agents and anti-psychotic agents. Both classes of medications have numerous significant side effects. Establishing that ramelteon is helpful in the sleep of patients with bipolar disorder and helpful in mood stability will increase the number of treatment options for bipolar patients.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of written informed consent before initiation of any study-related procedures
2. Men and women aged 18 to 65 years.
3. A documented clinical diagnosis according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision) meeting criteria 296.4x Bipolar I disorder, most recent episode manic, 296.6x Bipolar I disorder, most recent episode mixed, or 296.5x Bipolar I disorder, most recent episode depressed.
4. PSQI total score of \>=5.
5. MADRS total score of \<=12.
6. YMRS total score of \<= 12
7. Female patients of childbearing potential must have a negative urine pregnancy test at enrollment and be willing to use a reliable method of birth control, i.e., double-barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device or tubal ligation, during the study.
8. Be able to understand and comply with the requirements of the study, as judged by the investigator.
9. Outpatient status at enrollment.

Exclusion Criteria:

1. Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status.
2. Presence of prohibited medications of antidepressants (including MAOI's) and systemic corticosteroids.
3. Patients with a diagnosis of primary insomnia disorders
4. Patients with a diagnosis of severe chronic obstructive pulmonary disease
5. A clinical finding that is untreated (eg, hypertension, poorly controlled diabetes, angina) or that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect the study medication.
6. Patients with active substance abuse diagnoses (except tobacco abuse).
7. Known history of intolerance or hypersensitivity to ramelteon or to any other component in the tablet.
Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in Frequent Platelets Donors

In this study, the investigators will evaluate the immunogenicity of a quadrivalent conjugate meningococcal vaccine in healthy, plateletpheresis donors.

This will be an open-label prospective vaccine response study evaluating one dose of MenACWY-D in plateletpheresis donors at the Brigham and Women's Hospital (BWH). Potential participants will be divided into three groups according to the number of plateletpheresis within 365 days of enrollment (including the day of enrollment): 1-2 sessions group (considered as the control group), 3-19 sessions group, 20-24 sessions group and randomly sampled from in allocation proportions of 0.45, 0.10, and 0.45, respectively; justification for this approach is provided in the Statistical Analysis section. MenACWY-D vaccine will be administered to each patient. Pre- and post-vaccination blood will be collected to assess immunogenicity, likely using serum bactericidal antibody (SBA) against Neisseria meningitidis for each serogroup. Immunogenicity will be primarily evaluated by seroresponse such as a fourfold increase of SBA titers between pre- and post-vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years old or older
* Meet the standard requirements to donate platelets
* Have had at least one plateletpheresis in the prior 365 days (including the day of enrollment)

Exclusion Criteria:

* Participants who donated platelets in any other medical center in the previous 365 days
* Severe allergic reaction to a previous meningococcal vaccine or to any component of MenACYW-D
* History of Guillain-Barré syndrome
Augmenting Exposure Therapy for Social Anxiety With Transcranial Direct Current Stimulation

This study will examine whether transcranial direct current stimulation (tDCS) can be used to improve outcomes from exposure therapy for social anxiety disorder, and facilitate extinction of fear responding toward individuals outside one's own ethnic group (i.e., ethnic out-group members).

Although exposure therapy is among the most powerful treatment techniques for social anxiety, many individuals do not achieve full remission. Furthermore, some research suggests that fear responding toward ethnic out-group members may be more resistant to extinction. Enhancing activation of the mPFC during exposure therapy may improve overall response to treatment, and also facilitate extinction of fear toward ethic out-groups. Researchers have found that greater mPFC activation during exposure therapy is associated with better outcomes, and that transcranial direct current stimulation (tDCS) can be used enhance learning and cognition with no known serious adverse effects. This study will therefore examine whether active/anodal (versus sham) tDCS targeting the mPFC (a) enhances overall reductions in social anxiety symptoms, and (b) facilitates extinction of fear responding toward ethnic/racial out-groups for both Latino and Caucasian/non-Latino participants. Participants will receive either active/anodal tDCS or sham tDCS during a brief exposure therapy intervention involving public speaking in a Virtual Reality (VR) environment. The public speaking audience in the VR environment will alternate between audiences that are either matched or unmatched to the participant's ethnicity (in a randomly assigned order). Participants' fear reactivity will be assessed with behavioral, physiological, and subjective measures at baseline, post-treatment, and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older (adult)
* Enrolled in higher education (post-high school)
* Elevated public speaking anxiety as indicated by self-report questions
* NOT currently receiving in exposure therapy for social anxiety

Exclusion Criteria:

* History of seizure or any other neurological diagnosis
* Has any metal in their skull (plates, steel sutures, etc.)
* Participant is currently taking anti-convulsant, sedative/hypnotic, or antipsychotic medications
* Participant is pregnant
* Participant has already participated in a prior tDCS/tACS study on the same day as study visit 1 (which will involve either placebo or active/anodal tDCS stimulation)
Evaluating an Internet-based Intervention for Insomnia in Breast Cancer Survivors

This study examines the efficacy of an Internet-delivered intervention to reduce symptoms of insomnia in breast cancer survivors. Breast cancer patients with insomnia (N=30) will be assigned to either gain access to the 6-week treatment program immediately (experimental group) or following study participation (control group).


Eligibility Criteria:
Inclusion criteria:

* Female
* Diagnosed with breast cancer
* Age 18 and older
* Completed primary treatment at least one month prior to enrollment
* Diagnosis of insomnia

Exclusion criteria:

* Experiencing a sleep disorder other than insomnia (e.g., sleep apnea)
* Experiencing a major depressive episode or other serious psychiatric disturbance
* Modification of psychotropic medications within the previous month
* Undergoing current psychotherapy treatment
ISIS 2503 in Treating Patients With Advanced Cancer of the Pancreas

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of ISIS 2503 in treating patients who have advanced cancer of the pancreas.

OBJECTIVES: I. Determine the response rate and time to progression in patients with advanced adenocarcinoma of the pancreas who are treated with ISIS 2503. II. Determine the duration of response in these patients receiving this regimen. III. Characterize the safety profile of ISIS 2503 at the recommended phase II dose and schedule in these patients.

OUTLINE: Patients receive ISIS 2503 IV continuously for 14 days. Treatment continues every 21 days for a minimum of 3 courses in the absence of unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: A total of 14-27 patients will be accrued for this study within 12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed advanced adenocarcinoma of the pancreas that is considered inoperable Measurable disease with at least 1 lesion measuring at least 2 cm in widest diameter identifiable on CT or MRI scan

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 6 months after study No underlying disease state associated with active bleeding No active infection requiring therapy No other prior malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy for pancreatic cancer Chemotherapy: No prior chemotherapy for pancreatic cancer except for fluorouracil and/or gemcitabine administered as a radiosensitizer No other concurrent chemotherapy for pancreatic cancer Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed provided indicator lesions not within prior radiation port Recovered from toxicity No concurrent radiotherapy for pancreatic cancer Surgery: See Disease Characteristics Other: No concurrent anticoagulation therapy with heparin No other concurrent approved or experimental cancer therapy
Hyperbaric Oxygen Therapy as a Neuroprotective Intervention in Pediatric Acquired Brain Injury With Cognitive Disability

This research aimed to investigate the effectiveness of hyperbaric oxygen therapy as a neuroprotective strategy for improving neurological outcomes in pediatric patients who have sustained acquired brain injury.

Hyperbaric oxygen therapy (HBOT) is a medical treatment that delivers high-concentration oxygen in a pressurized chamber. It was developed initially from diving physiology research and popularized by Dutch surgeon Boerema for its life-sustaining plasma oxygen diffusion under hyperbaric conditions.

The fundamental mechanism of HBOT operates through Henry's Law, enabling unprecedented increases in tissue oxygen partial pressures that surpass levels achievable in normal atmospheric conditions.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients aged 4-12 years with acquired brain injury.
* Confirmed neurological sequelae (e.g., cardiac arrest, intracranial hemorrhage, central nervous system infections, stroke, tumor, hypoxia) via MRI/neurological exam.

Exclusion Criteria:

* Positive family history of degenerative brain insults.
* Behavioral problems.
* Hyperbaric oxygen therapy contraindications:

  * Active epilepsy.
  * Respiratory insufficiency.
  * Uncontrolled heart failure.
  * Eustachian tube dysfunction.
  * Tympanic membrane rupture.
  * Mechanical ventilation dependency.
Peri-implant Marginal Bone Loss and Implant Failure in Patients With Smoking Habit

The impact of smoking on dental implant failure has been a constant topic of discussion for the past decade and the current literature confronts the inconclusive evidence of tobacco for a marginal bone loss risk factor. The aim of the present investigation is to determine the association between tobacco and marginal bone loss or implant failure in a sample of patients who had received implant-supported restorative therapy in the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge).

Considering that peri-implant marginal bone is essential for dental implant success, in this study we would like to establish the relationship between marginal bone loss around implants and smoking, in our own population study, in order to improve the prognosis of implant success in smoking patients.

On the other hand, knowing the negative effect tobacco has on marginal bone loss in dental implants, we will be able to better predict peri-implant bone loss and reveal the probability of implant failure in short and long-term in smokers. By informing the patient correctly, we can raise awareness and create an additional reason for them to stop smoking, or at least reduce the number of cigarettes they smoke per day.

The present study was designed as a retrospective case control study in a sample of patients with implant-supported restorative therapy conducted at the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge). It is designed following the principles outlined in the Declaration of Helsinki (revised, amended, and clarified in 2013). All of the patients are being properly informed about the study according to the Comité Ético (CEIC) del Hospital Odontològic Universitat de Barcelona guidelines, and informed consent must be signed prior to the interventions. Patients provided with implant-supported restorative therapy were selected from the DHUB database. The sample is divided in two groups: smoking and non-smoking patients. An initial questionnaire is being conducted to obtain information regarding smoking habits. Candidates undergo an oral examination, radiographic study (Orthopantomography and Implant periapical radiograph) and implant probing to determine their peri-implant status.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a Smoking Habit
2. Patients 20 - 80 years old
3. Patients rehabilitated at DHUB
4. Patients with a radiographic record at the time of implant loading
5. Patients rehabilitated with one or more dental implants

Exclusion Criteria:

1. Patients with untreated periodontal disease
2. Patients with uncontrolled systemic pathology
3. Pregnant women or in lactation
4. Patients treated with antiresorptive drugs
5. Patients without radiographic records