cyrilzakka/clinical-trials huggingface dataset:
Hippocampal-sparing Whole Brain Radiotherapy for Brain Metastases From Breast Cancer

Based on evidence that radiation-induced damage to the hippocampus plays a considerable role in neurocognitive decline after cranial irradiation, hippocampal-sparing whole brain radiation therapy (HS-WBRT) has been proposed. This study will investigate the neurocognitive function and prognosis between HS-WBRT and conventional WBRT for the treatment of brain metastases from breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Female patients with advanced breast cancer who is confirmed historically.
* New developing brain metastases (BM) is confirmed by gadolinium contrast-enhanced magnetic resonance imaging (MRI), with or without clinical symptoms and pathology, and without a history of BM treatment.
* At least 2 BM lesions with the diameter of the largest lesion \< 40 mm is eligible. And the distance from the border of a mass to the hippocampal margin should be more than 15 mm.
* The Eastern Cooperative Oncology Group (ECOG) is from 0 to 2, and the expected life expectancy is ≥3 months.

Exclusion Criteria:

* Concurrent chemoradiation.
* Patient who had received cranial irradiation previously.
* Patient who are enrolled in other clinical trial at the same time.
* Patient who has severe co-morbidity or infection.
Atypical Lesions of the Breast: Close Observation Versus Excision (ALCOVE)

This study is designed to look at whether it is feasible to observe women with atypical ductal hyperplasia (ADH) of the breast, or whether surgical excision is necessary.

We hypothesize that surgical excision may not yield an improvement in survival over hormonal therapy and/or close observation alone in patients who present with ADH on core needle biopsy of the breast. An alternate (non-inferior) strategy for management may be possible, and may be associated with improved quality of life and fewer complications, and lower overall costs. Although several researchers have suggested a clinical trial to investigate this idea this would be the first time it has been done, and could therefore be practice changing.

Eligibility Criteria:
Inclusion Criteria

A patient/subject is eligible for enrollment if all of the following inclusion criteria are met:

1. Pre- and post-menopausal women ≥ 40 years of age with newly diagnosed ADH, histologically confirmed on breast core biopsy.
2. Ability to understand and the willingness to sign a written informed consent document.
3. Willing to schedule definitive resection of ADH if randomized to surgical excision arm or be observed if randomized to the observation arm.
4. Original breast core biopsy specimen available for pathologic review and staining by Yale School of Medicine Department of Pathology.

Exclusion Criteria

A patient/subject will not be eligible for this study if any of the following exclusion criteria are met:

1. Patients with a current breast cancer diagnosis or a personal history of cancer
2. Patients with a personal history of an identifiable genetic mutation (BRCA) for breast cancer and, untested first degree relatives of mutation carriers
3. Patients who have previously or are currently taking tamoxifen or exemestane or other chemotherapy or biologic therapy (e.g. trastuzumab)
4. Patients with a history of radiation therapy to the chest wall
5. Pregnant and/or lactating women within past 6 months.
Determining Optimal Dosage of Prone Positioning in Early Infancy

The proposed study is a longitudinal, randomized control trial designed to determine the dosage of daily 'tummy time' needed in early infancy to influence ideal motor development and healthy body composition. Infants will be randomly assigned to one of three 'tummy time' groups: a group prescribed 0 to 30 minutes per day; a group prescribed 31 to 60 minutes per day; and, a group prescribed 61 or more minutes per day. Families will be encouraged to achieve the maximal minutes prescribed for their group and will keep a log of their daily tummy time. Participating infants will be assessed in their home for motor development and body composition at study entry and again every month for 12 months, at 15 months of age and at 18 months of age.

Prone positioning or 'tummy time' in early infancy is advocated as important to support early motor development, improve overall strength, and prevent flattening of the back of the head. The American Academy of Pediatrics state that "a certain amount of prone positioning, or 'tummy time,' while the infant is awake and being observed is recommended to help prevent the development of flattening of the occiput and to facilitate development of the upper shoulder girdle necessary for timely attainment of certain motor milestones." However, specific recommendations on appropriate dosage of prone positioning are not available. In the absence of these specific recommendations, many infants may not be engaging in sufficient 'tummy time' for timely motor development. Moreover, insufficient 'tummy time' is linked to heightened obesity risk in early life. Given the increasing incidence of obesity in infants, primary preventative efforts need to begin early to reduce this risk.

The proposed study is a longitudinal, randomized control trial designed to determine the dosage of daily 'tummy time' needed in early infancy to influence ideal motor development and healthy body composition. Infants will be randomly assigned to one of three 'tummy time' groups: a group prescribed 0 to 30 minutes per day; a group prescribed 31 to 60 minutes per day; and, a group prescribed 61 or more minutes per day. Families will be encouraged to achieve the maximal minutes prescribed for their group and will keep a log of their daily tummy time. Participating infants will be assessed in their home for motor development and body composition at study entry and again every month for 12 months, at 15 months of age and at 18 months of age. Once a participant can independently transition in and out of the sitting position, the family will no longer be responsible for performing deliberate 'tummy time' activities or logging, but monthly motor development and body composition will continue to be monitored until the participant is 18 months of age.

Eligibility Criteria:
Inclusion Criteria:

* full term infants with typical development

Exclusion Criteria:

* premature birth before 37 weeks gestation; known medical condition or diagnosis; any complications that limit full participation in the intervention activities
Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis

The study aims to determine the safety and efficacy of buffered hypertonic (1.8%) saline nasal rinses as compared to isotonic saline nasal rinses in patients with chronic rhinosinusitis (CRS). Evidence from basic science research suggests that hypertonic solutions may have beneficial effects over isotonic saline rinses; however prior clinical studies on this topic have been inconclusive and limited due to highly variable inclusion criteria, large variability in the volume and concentration of irrigation solution, and inconsistent outcome measures. The goal of the study is to utilize a cross over study design to directly compare the impact of two different types of saline irrigation.

Primary aim:

Compare the efficacy of buffered hypertonic saline irrigations to buffered isotonic saline irrigations on patient reported outcome measures of chronic rhinosinusitis symptoms and nasal obstruction in patients with CRS. Based on in vivo data and prior clinical studies, the investigators expect participants will experience greater symptom improvement with hypertonic saline rinses as compared to isotonic saline irrigations.

Hypothesis: Participants will have greater improvement in patient reported outcome measures (SNOT-22 and NOSE) when using buffered hypertonic sinus irrigations as compared to buffered isotonic saline irrigations.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of chronic rhinosinusitis with or without polyposis based on the criteria outlined in the American Academy of Otolaryngology-Head and Neck Surgery's Clinical Practice Guideline
2. SNOT-22 score \>/= 20

Exclusion Criteria:

1. Sinus surgery within 30 days of beginning the study
2. Oral steroid use within two weeks of study initiation
3. Active sinus exacerbation or sinus exacerbation within two weeks of starting the study
4. Allergies or contraindications to fluticasone nasal spray
Perception Prognosis, Goals of Treatment, and Communication

The purpose of this research study is to assess what the participant understands about their illness, prognosis, the goals of the cancer treatment and their communication with their oncology providers. This study will help us to figure out how the investigators can improve how other patients understand their illness and goals of treatment and help us improve communication with their doctors. This research is being done because there is not a lot of information on how much patients understand about their illness and prognosis.

* Participants will be asked to answer a few basic questions regarding race, ethnicity, religion, relationship status, education, income, and living situation.
* They will then be asked to complete a questionnaire which contains questions about their mood, spirituality, quality of life and their understanding of their treatment and prognosis and their communication with their oncologist. They will complete these questionnaires in the clinic or infusion room on one of their regularly scheduled visit.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed new diagnosis of advanced gastric, esophageal, pancreatic, and hepatobiliary cancer, not being treated with curative intent.
* Planning to receive chemotherapy at Massachusetts General Hospital
* Ability to read and respond to questions in English.

Exclusion Criteria:

* Prior chemotherapy for current stage of disease.
Observing Patients With Palliative Asymptomatic Centrally Located Advanced Non-small Cell Lung Carcinoma (NSCLC)

The aim of the study is to assess current practice within PROP \& lung teams, for treating asymptomatic patients with centrally located non-small cell lung cancer (NSCLC), and to observe outcomes for those patients receiving immediate or deferred RT. This is a prospective cohort trial. Patients will be managed by immediate radiotherapy (RT) or a deferred approach according to physicians' individual current clinical practice. Baseline and follow-up data collection will be structured to focus on patient-reported measures to describe clinical outcomes in the two management groups. Indications for prescribing RT and dose fractionation schedules will also be collected. A new intervention will not be introduced during this trial. Instead, a follow-up regimen will be offered to both groups of patients, so that RT can be offered to the deferred group of patients if/when symptoms develop, and we can monitor symptoms/toxicities and QoL in both groups of patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed NSCLC
* Central disease, as defined by tumour (either primary or nodal disease) arising or extending within a 2cm circumferential expansion from the centre of the trachea or within the zone of the proximal bronchial tree
* Disease is visible on thoracic CT (diagnostic or simulation)
* Asymptomatic from intra-thoracic tumour (may have background chest symptoms related to underlying COAD etc, but these symptoms must not have worsened due to tumour)
* Patient (due to age or co-morbidities) or tumour (due to locally advanced or metastatic disease) is not suitable for radical treatment (defined as surgery or RT dose \>50Gy in 20 fractions or equivalent).
* Previous chemotherapy, thoracic RT or surgery is allowed
* RT to other metastases (e.g. brain, bone etc) is allowed

  •≥ 18 years of age
* Able to provide written informed consent

Exclusion Criteria:

* Intra-thoracic disease is peripheral only, not extending within 2cm of trachea/proximal bronchial tree
* Symptomatic from intra-thoracic NSCLC
* Histological diagnosis of small cell lung cancer, or malignant mediastinal lymphadenopathy from another malignancy (not NSCLC)
Comparative Atorvastatin Pleiotropic Effects

The primary objective of the study is to evaluate the efficacy of atorvastatin 80 mg daily as compared to atorvastatin 10 mg daily in reducing C-reactive protein levels over a 26-week treatment period in subjects with documented coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects of age of majority to \< 80 years
* Subjects with LDL-C \> 0.5 g/L (1.29 mmol/L) and \< 1.5 g/L (3.87 mmol/L), TG \< 4.00 g/L (4.56 mmol/L) and hs-CRP \>1.5 mg/L and \< 15 mg/L
* Subjects with a documented coronary artery disease.

Exclusion Criteria:

* Female subjects of childbearing potential without contraception
* Subjects with secondary hyperlipidemia
* Diabetic subjects receiving insulin
* Subjects with a contra-indication to statin therapy.
Computer-Facilitated 5A's for Smoking Cessation in Primary Care

This study tests the use of handheld computer tablets to promote the integration of 5A's (Ask, Advise, Assess, Assist, Arrange) for smoking cessation in academic and community primary care clinics. Although most patients receive the "ask" and "advise" steps, only slightly more than half are "assessed" for readiness to change, less than half receive "assistance" in changing, and only 9% have an "arranged" follow-up. While the large majority of primary care providers support the 5A's model, negative attitudes and the lack of time, knowledge, and cessation skills are common obstacles. Alternate service delivery systems that address these obstacles and evidence-based strategies to promote their implementation are needed to improve provider adherence and 5A's fidelity.

This project develops and tests a computer-facilitated 5A's (CF-5A's) model that administers the 5A's intervention to patients then prompts providers for reinforcing next steps. CF-5A's could efficiently and effectively promote smoking cessation while educating providers about cessation resources and appropriate follow-up. Based on the Technology Acceptance Model, clinically tailored strategies to promote CF-5A's implementation will be developed and tested to ensure the appropriate use and uptake of this new service delivery model. Development of the model, materials, and strategies will occur in years 1 and 2.

Baseline data collection occurs in year 2, followed by a randomized trial of CF- 5A's where the provider is the unit of randomization. Provider use of the 5A's will primarily be assessed with a brief phone call to the patient after the primary care visit has occurred.

Although focused on 5A's for smoking cessation, this study examines the underlying implementation science of computer-aided service delivery models with important implications for the integration of other substance use or behavioral health interventions in primary care. Implementation factors will be assessed using qualitative interviews and brief pre-post surveys.

Eligibility Criteria:
Inclusion Criteria: All primary care providers and clinic staff are eligible to participate. Patients must have

* a primary care appointment
* smoked a cigarette in past 7 days
* smoked at least 100 cigarettes in lifetime
* speak English or Spanish
* be cognitively able to use computer tablet

Exclusion Criteria:

* Moderate to severe cognitive impairment
* Does not speak English or Spanish
* acute intoxication on alcohol or illicit drugs
Safety and Tolerability of High Dose Biotin in Patients With Amyotrophic Lateral Sclerosis

This is a randomized double blinded randomized 2:1 study. The duration of the study is 6 month. The safety and tolerability of high doses of biotin (300 mg/ day) will be compared to placebo in patients with amyotrophic lateral sclerosis. Patients will be evaluated at baseline, 3, and 6 month. The primary outcome will be any adverse effects recorded. The secondary outcomes will be motor disability measured by ALS-FRS, change in Pulmonary function test parameters (FEV1- FVC), change in subject weight (in kg).


Eligibility Criteria:
Inclusion Criteria:

* Amyotrophic Lateral Sclerosis (ALS) volunteers must be diagnosed within 3 years prior to participation as having possible, probable, or definite ALS, either sporadic or familial according to modified El Escorial criteria
* Age 18-80, able to provide informed consent, and comply with study procedures
* Participants must not have started Riluzole and/or Nuedexta for at least 30 days, or be on a stable dose of Riluzole and/or Nuedexta for at least 30 days, prior to screening (Riluzole and/or Nuedexta -naïve participants are permitted in the study)

Exclusion Criteria:

* The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the participant to provide informed consent, according to PI judgment.
* Exposure to any experimental agent within 30 days of entry or at any time during the trial or enrollment in another research study within 30 days of or during this trial.
* Slow Vital Capacity test less than 50% of the predicted value Patients who had already undergone tracheostomy
Neurofeedback During Eating for Bulimia Nervosa

The purpose of this study is to examine the effects of noninvasive prefrontal cortex (PFC) neurofeedback during eating in women with bulimia nervosa (BN) using a wearable brain imaging device, functional near-infrared spectroscopy (fNIRS). The investigators will examine how this training may influence inhibitory control and BN symptoms.

The purpose of this study is to examine the effects of PFC neurofeedback during eating in women with bulimia nervosa (BN) using fNIRS. Specifically, the study aims 1) to demonstrate ventrolateral PFC (vlPFC) neurofeedback target engagement in women with BN using fNIRS; and 2) to link changes in PFC activation to changes in inhibitory control and eating-related symptoms.

Data will be collected from women with BN who will be randomly assigned to one of two group conditions (real or sham-control neurofeedback during eating). Participation includes a phone screening assessment, psychodiagnostic assessment, one in-person evaluation, one neurofeedback session, behavioral tasks, online questionnaires before and after the neurofeedback session, and a remote follow-up assessment.

Eligibility Criteria:
Inclusion criteria:

* Female
* Aged 18 to 45 years
* Meet diagnostic criteria for bulimia nervosa
* Current body mass index greater than or equal to 18.5kg/m2 but under 30kg/m2
* English-speaking

Exclusion criteria:

* Ongoing medical treatment, major medical condition, or psychiatric disorder that may interfere with study variables or participation
* Current psychotherapy focused primarily on eating disorder symptoms
* Pregnancy or planned pregnancy, or lactation during the study period
* Allergy to ingredients in the standardized meal or in the shake
Tyrosine Hydroxylase Antibody Levels in Autoimmune Polyglandular Syndrome Type 1 Associated Keratitis

Tyrosine hydroxylase autoantibodies impair sympathetic innervation leading to keratitis. In this study, the investigators have shown the significant association between severity of keratitis and presence of tyrosine hydroxylase autoantibodies.

Sixteen consecutive cases diagnosed with APS-1associated keratitis were included in this study. Each patient underwent complete ophthalmologic examination. Blood was obtained from each patient for testing the endocrine functions and determination of a panel of autoantibodies to the following: Side-chain cleavage enzyme (SSC), Aromatic L-amino acid decarboxylase (AADC), Tryptophan hydroxylase (TPH),Tyrosine hydroxylase ( TH), 17 α-hydroxylase (17α-OH), Cytochrome P450 1A2 (CYP1A2), 21-hydroxylase (21-OH), Potassium channel regulatory protein (KCNRG), Tyrosine phosphatase-like protein IA-2 (IA-2), Glutamic acid decarboxylase 65 (GAD65), NACT Leucine-Rich-Repeat-Protein 5 (NALP5), and Interleukin (IL) 22.

Eligibility Criteria:
Inclusion Criteria:

* consecutive patients diagnosed with APS-1associated keratitis

Exclusion Criteria:

* None
Cohort of Peripheral T Cell Lymphoma

Prospective, observational cohort study of peripheral T cell lymphoma. Purpose is to investigate the complication including febrile neutropenia in the era of pegylated G-CSF prophylaxis.

Prospective evaluation of frequencies of febrile neutropenia or infectious complications in a homogeneous population of patients with peripheral T cell lymphoma

Eligibility Criteria:
Inclusion Criteria:

1. Treatment naive peripheral T cell lymphoma

   Subtypes are as followings:

   Anaplastic large cell lymphoma angioimmunoblastic T cell lymphoma Peripheral T cell lymphoma-NOS Enteropathy-associated T cell lymphoma Hepatosplenic T-cell lymphoma Subcutaneous panniculitis-like T-cell lymphoma Primary cutaneous gamma-delta T-cell lymphoma Primary cutaneous CD8+ aggressive epidermotropic lymphoma
2. Scheduled to receive chemotherapy of curative intent
3. 19 years old or over
4. Expected survival is more than 6 months
5. Informed consent

Exclusion Criteria:

1. Other histology than those described above

   * Extranodal NK/T cell lymphoma
   * Other than peripheral T cell lymphoma
2. Other combined malignancy
3. Previous history of chemotherapy or radiation therapy
4. No informed consent
A Single-arm Trial of Prophylactic Tocilizumab for Acute GVHD Prevention After Haploidentical HSCT.

A single-arm trial using Tocilizumab for acute GVHD prophylaxis after haploidentical HSCT.

This study will enroll haploidentical HSCT patients with high risk for acute GVHD. Tocilizumab (8mg/kg) will be added to the conventional acute GVHD prophylaxis regime (CsA+Methotrexate(MTX)+low dose mycophenolate mofetil(MMF)+ATG) on day -1 of transplant. The previous patients will be used as control.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hematological malignancies in complete remission (CR) who are eligible and planned for haploidentical HSCT. The donor specific antibody is negative
* Patient age 16-60 years
* Mother donor, or female donor (age \>50) for female-male transplant
* Eastern Cooperative Oncology Group (ECOG) performance status \< 2
* Creatinine clearance rate \> 60 mL/min (estimate by Cockcroft-Gault Equation)
* alanine transaminase (ALT) and aspartate aminotransferase (AST)≤ 2.5×upper limit of normal (ULN), and total bilirubin ≤ 1.5×ULN （upper limit of normal, ULN）
* Left ventricular ejection fraction (LVEF) ≥50% as measured by echocardiography
* Acceptation to sign the informed consent

Exclusion Criteria:

* History of previous HSCT
* Present active infection (including bacterial, virus or fungal)
* History of Tocilizumab infection
* History of inflammatory bowel disease
* History of demyelinating disease
* Patients who are HIV-positive, or with uncontrolled chronic hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV) infections
* Women who are pregnant (β-chorionic gonadotropin+) or breast feeding
* Refusal to sign the informed consent
An Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia

This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of sub-optimally controlled symptoms of schizophrenia during a 12-week outpatient treatment period. The study will use the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms for PF-02545920 from baseline compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Psychiatrically stable subjects with schizophrenia who have had a suboptimal response to current treatment
* Evidence of stable schizophrenia symptomatology greater than or equal to 3 months.
* Subjects must be on a stable medication treatment regimen greater than or equal to 2 months, including concomitant psychotropic medications.

Exclusion Criteria:

* History of seizures or of a condition with risk of seizures.
* Subjects with schizophrenia that have not responded at all to current treatment.
* Pregnant or nursing females, and females of child bearing potential.