cyrilzakka/clinical-trials huggingface dataset:
A Study of Herceptin (Trastuzumab) in Combination With Avastin (Bevacizumab) and Sequential Xeloda (Capecitabine) or Docetaxel in Patients With HER2-Positive Locally Recurrent or Metastatic Breast Cancer

This single arm, open-label study will evaluate the safety and efficacy of Herceptin in combination with Avastin and sequential Xeloda in patients with locally recurrent or metastatic HER2-positive breast cancer after early relapse on adjuvant Herceptin therapy. Patients will receive Herceptin at a loading dose of 8mg/kg iv followed by 6mg/kg iv every three weeks, and Avastin 15mg/kg every 3 weeks. At first sign of disease progression Xeloda 1000mg/m2 bid po will be added on days 1-14 of each cycle, or docetaxel (100mg/m2 iv every 3 weeks) if Xeloda is not indicated for a patient. Anticipated time on study treatment is until disease-progression on second line treatment and target sample size is \<100.


Eligibility Criteria:
Inclusion Criteria:

* male or female patients, age \>/=18 years
* locally recurrent or metastatic HER2-positive breast cancer
* disease progression during or up to 12 months after prior adjuvant therapy with trastuzumab
* LVEF \>/=55% at baseline

Exclusion Criteria:

* prior treatment with bevacizumab or capecitabine
* anthracyclines in prior adjuvant or neoadjuvant treatment exceeding cumulative dose of 360mg/m2 for doxorubicin and 720mg/kg for epirubicin
* chronic daily treatment with corticosteroids (\>10mg/day methylprednisolone equivalent; excluding inhaled corticosteroids), or aspirin (\>325mg/day), or clopidogrel (\>75mg/day)
* clinically significant cardiac disease, or cardiac toxicity during previous trastuzumab therapy
* evidence of spinal cord compression or CNS metastasis
* history of other malignancy, unless disease-free for \>/=5 years or treated curatively for carcinoma in situ of the cervix or non-melanomatous skin cancer
Techniques to Enhance Patient Comfort in Sedation-risk Free Colonoscopy

Hypotheses

1. Loading the sigmoid colon with warm water and warm water irrigation for dealing with spasm (Study Treatment) will significantly reduce the proportion of patients complaining of abdominal discomfort compared with no water loading and waiting for spasms to subside (Control Treatment). The median discomfort score reported by the patients will be significantly lower in the group receiving the Study Treatment than the group receiving Control Treatment. Hypothesis
2. Exploratory hypothesis: There are differences in secondary outcome variables when patients managed by the Study and Control Treatments are compared. Co-variables affect the primary and secondary outcome variables.

The purpose of the study is to conduct a RCT study to determine the effectiveness of loading the sigmoid colon with warm water and warm water irrigation for dealing with colonic spasms in enhancing patient abdominal comfort during unsedated colonoscopy. The specific aim is to compare Study Treatment of warm water loading and irrigation when spasms occur with Control Treatment of no water loading and waiting for spasms to subside. The proportion of patients complaining of abdominal discomfort and their discomfort score are the primary outcome variables. The secondary outcome variables and co-variables described below will be recorded in a prospective manner to ensure completeness of data collection. In preliminary clinical observation at VA Sepulveda ACC, 25 to 30% of VA patients accept colonoscopy without sedation. The goal of this study is to find ways of further reducing discomfort associated with unsedated colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Accepts adult healthy male and female patients
* At least 18 years of age
* In need of colonoscopy for screening or follow up of colonic polyps
* Willing to consent and be randomized

Exclusion Criteria:

* Patients receiving outpatient narcotic treatment
* Patients who report excessive anxiety
* Patients with moderate to severe abdominal discomfort
* Unable to provide consent
* Have poor bowel preparation
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Reconstruction System

The study is a monocentric, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the Reconstruction System (implants and instrumentation) when used for temporary internal fixation and stabilization of fractures during the normal healing process.

The primary objective is the assessment of performance by analyzing fracture healing.

The secondary objectives are the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. Subjects' outcomes will also be assessed.

The Reconstruction System is especially used to stabilize pelvic ring and acetabulum fractures. One site will be involved in this study. The aim is to include a maximum of 83 consecutive series cases who received the Zimmer Reconstruction System at the Azienda Ospedaliero Universitaria Senese (Siena, Italy) between 2010 and 2018. All potential study subjects will be required to participate to the Informed Consent process.

Baseline data from the preop, intraop, immediate post-op and last consultation visit will be available in medical notes and collected retrospectively. In addition, any complications since the last consultation visit at the clinic and information about the treatment of the complications will also be collected retrospectively.

Eligibility Criteria:
Inclusion Criteria:

Patients having received the Zimmer Reconstruction System for temporary internal fixation and stabilization of fractures during the normal healing process

Exclusion Criteria:

* Off-label use
* Patients under the age of 18
* Severely comminuted fractures in which bone fragments are too small or numerous to adequately fix or maintain a reduced position
* Infection
* Metal sensitivity or intolerance
* Severe osteopenia and/or osteoporosis, or in the presence of marked or rapid bone absorption, metabolic bone disease, cancer, or any other tumor-like condition of the bone which may compromise fixation
* Sternal or spinal fractures
* Anatomical location in which the device would interfere with nerves, blood vessels, or other vital structures
* Patients with inadequate soft tissue coverage at the implant site
PMCF Study on the Safety, Performance and Clinical Benefits of the DVR Plating System

The study is a single-center, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the DVR Plates. The primary objective is the assessment of performance by analyzing fracture healing. The secondary objective is the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. Patients' outcomes will also be assessed.

The DVR plating system in this study includes the DVR Crosslock Distal Radial Plate, the DVR Volar Rim Plate and the DVR Wrist Plates.

One site will be involved in this study. The aim is to include a total of 112 consecutive series patients treated between 2014 and 2018. All potential study subjects will be required to participate in the Informed Consent Process.

Baseline data from the preop, intraop, immediate post-op and last consultation visit will be available in medical notes and collected retrospectively. During a follow up phone call the patient will be asked to complete a patient questionnaire and a question on his/her wrist function. In addition, any complications since the last consultation visit at the clinic, information about and treatment of the complications will also be collected over the phone.

Eligibility Criteria:
Inclusion Criteria:

* All subjects must have been implanted with one of the DVR Plates according to the approved indications.

Exclusion Criteria:

* Off-label use.
* Cases where there is an active infection.
* Conditions which tend to retard healing such as, blood supply limitations, previous infections, etc.
* Insufficient quantity or quality of bone to permit stabilization of the fracture.
* Conditions that restrict the patient's ability or willingness to follow postoperative instructions during the healing process.
* Foreign body sensitivity - where material sensitivity is suspected, appropriate tests should be conducted and sensitivity ruled out prior to implantations.
* Cases where the implant(s) would cross open epiphyseal plates in skeletally immature patients.
* Cases with malignant primary or metastatic tumors which preclude adequate bone support or screw fixations, unless supplemental fixation or stabilization methods are utilized.
Cognitive Behavioral Therapy for Anxiety and Depression in COPD

The purpose of this study was to examine the efficacy of manualized, short-term group cognitive behavioral therapy for COPD patients suffering from clinically significant symptoms of anxiety and/or depression.

Anxiety and depressive disorders have been demonstrated in 16-50% of patients with chronic obstructive pulmonary disease (COPD), and clinically significant levels of anxiety or depressive symptoms seem to be even more common.Despite the multiple, severe consequences, majority of COPD patients with co-morbid anxiety or depression do not seem to receive any treatment for the psychological disturbance.

Cognitive behavioral therapy (CBT) is a well-known approach for treating anxiety and depression, and data has demonstrated effectiveness of CBT for older individuals with anxiety. CBT has also improved exercise tolerance compliance in COPD patients, and pilot studies using CBT components have shown effectiveness in improving mental health and functional status for patients with COPD.

Given the increasing number of patients suffering from COPD and the high prevalence of anxiety and depression in the population, the current study was designed to examine the efficacy of CBT in groups for anxiety and depression in patients with COPD. At present, CBT-based interventions focusing on mental health symptoms are not widely available for COPD patients, and the potential of CBT for improving emotional well-being is not systematically considered in existing treatment alternatives. The study expands the findings from previous pilot studies by focusing on COPD patients with clinically significant levels of anxiety and depression. The wide breadth of coping skills included in the CBT intervention target symptoms of both anxiety and depression, and thus the utility of the intervention for managing mental health symptoms is not restricted to any specific DSM-IV diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* 40 years or older
* scores of 16 or higher on the Beck Anxiety Inventory and/or 14 or higher on the Beck Depression Inventory II
* COPD diagnosis

Exclusion Criteria:

* participation in other studies likely to influence the patient in terms of confounding effects
* signs of cognitive impairment defined by a score of less than 23 on the Mini-Mental State Examination
* presence of psychotic disorders, non-nicotine substance use disorders, bipolar disorders, or suicidal intentions as identified by clinical assessment based on the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID-I/P)
* having a serious somatic condition preventing active participation in the present study
Deep Learning for Histopathological Classification and Prognostication of Gynaecologic Smooth Muscle Tumours

Smooth muscle tumors of the uterus that do not fit the diagnostic criteria of benignity (such as leiomyomas) or malignancy (such as leiomyosarcomas) are called STUMP (smooth muscle tumor of uncertain malignant potential). A potential solution to this problem could be the application of predictive models using artificial intelligence (AI) to aid in the histopathological classification and prognosis of gynecological smooth muscle tumors. Deep learning using convolutional neural networks represents a specific class of machine learning, in which predictive models are trained by considering small groups of pixels in digital images and iteratively identifying salient features. In this study, we aim to develop deep learning models capable of accurately subclassifying and predicting the prognosis of gynecological smooth muscle tumors, based on histopathological features of hematoxylin and eosin (H\&E) slides. The aim is to develop a diagnostic and prognostic algorithm to help pathologists better classify and diagnose uterine smooth muscle tumors and predict their clinical course.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of uterine smooth muscle tumors (leiomyomas, smooth muscle tumors of uncertain malignancy and leiomyosarcomas), registered in the RRePS database and/or treated at Institut Bergonié or one of the participating centers.
* Histopathological material available (kerosene blocks and/or slides).

Exclusion Criteria:

* na
Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib

This study proposes to evaluate the number of chronic, Grade 1 or 2, non-hematologic Adverse Events (AEs) that reduce in grade or resolve at 3 months after switching therapy from imatinib to dasatinib.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CML-CP patients achieving an optimal response to imatinib treatment with Grade 1 or 2 non-hematologic adverse events persisting for at least 2 months or recurring at least 3 times in the preceding 12 months, despite best supportive care
* Men and women with Chronic Myeloid Leukemia- Chronic Phase (CML-CP) Ph+ ≥ age 18
* Daily Eastern Co-Operative Group (ECOG) performance status = 0 - 2
* Patient willing and able to give informed consent
* Life expectancy \> 6 months
* Adequate renal function
* Adequate hepatic function

Exclusion Criteria:

* Patients who are pregnant or breast feeding
* Men whose partner is unwilling to avoid pregnancy.
* Previous treatment with any other tyrosine-kinase inhibitor (TKI), except for imatinib
* Current grade 3 or 4 imatinib related adverse event
* Prior documented T315I mutation
* Prior diagnosis of accelerated phase or blast crisis CML
* Previous loss of complete hematologic response (CHR) or major cytogenetic response (MCyR) on imatinib
* Concurrent medical condition of uncontrolled infection, cardiovascular diseases of cardiac failure, congenital long QT syndrome, ventricular arrhythmias, prolonged QT interval, second or third degree heart block, uncontrolled angina, myocardial infarction (MI) in the last 6 months, uncontrolled hypertension, pulmonary arterial hypertension, pleural or pericardial effusions, or history of bleeding disorder
Combination Vaccination Before HIV Treatment Interruption

The purpose of this study is to determine if vaccination before a structured treatment interruption (STI) is associated with an improvement in immune function, resulting in a delayed and reduced rebound in the amount of HIV virus in the blood.

Volunteers will be randomly assigned to receive the vaccines or matching placebos before interrupting their antiretroviral therapy at week 24.

Dosage:

Remune(TM) 1 ml i.m.\* at weeks 0, 12, and 20; ALVAC 1 ml i.m.\* at weeks 8,12, 16, and 20.

\* i.m.: injected in a muscle

Eligibility Criteria:
Inclusion Criteria:

* Documented HIV infection (by serology)
* HIV RNA level below 50 copies/ml for at least two years
* Receiving at least 2 antiretroviral agents including at least 1 protease inhibitor or 1 non-nucleoside reverse transcriptase inhibitor at time of screening
* Have CD4 counts above 500 cells/ul
* Have CD4/CD8 ratio above 0.5
* Have never had a CD4 count below 250
* No previous AIDS-defining opportunistic infection
* No previous cancer chemotherapy or other system immunosuppressive therapy (excluding brief courses \[\<= 1 month\] of prednisone or its equivalent)
* Able to provide informed consent

Exclusion Criteria:

* Hepatitis B surface antigen positive
* Hepatitis C antibody positive
* AST, ALT, ALP, creatinine, urea above three times the normal upper limit
* Blood abnormalities (hemoglobin lower than 100, white blood cell count \[WBC\] lower than 1500 or platelets lower than 100)
* Allergies to components of Remune™ or ALVAC
* Contraindications to vaccine components
* Pregnancy or breastfeeding
Pragmatic Trial of Psilocybin Therapy in Palliative Care

This multicenter, triple-blind, phase 2, randomized controlled trial will evaluate the efficacy and safety of psilocybin therapy compared to an active control in treating demoralization in adults near the end of life (≤2 years life expectancy).

After providing written informed consent, participants deemed eligible for this trial will be randomized to a brief course of talk therapy plus 1 dose of oral psilocybin vs the same brief course of talk therapy plus 1 dose of oral ketamine (the active control). Participants' degree of demoralization and other clinical outcomes (e.g., depression, anxiety) will be assessed at 1, 2, and 5 weeks after the study drug administration. After completing the study, participants will have the option of being told which study drug they took (aka, "unblinded"); those who were randomized to the active control will be offered another brief course of talk therapy plus 1 dose of oral psilocybin, and the same sequence of outcome assessments.

Eligibility Criteria:
Inclusion Criteria:

General

* Provision of signed and dated informed consent form and the capacity to consent to research.
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Is currently a patient in a study-engaged clinical site
* Has a life-threatening illness and a life expectancy of ≤2 years
* Has moderate-to-severe demoralization
* Ability to take oral medication (capsules and liquid)

Exclusion Criteria:

General

* Known allergic or severe reactions to the non-psychoactive components of psilocybin capsules or liquid ketamine
* Treatment with another investigational drug or intervention within 1 month of signing Informed Consent Form (ICF)
* If deemed by clinical judgment of the study investigators to be unsafe for undergoing the intervention

Neurological

* Cognitive impairment sufficient to impede the ability to complete study tasks
* History of intracranial hemorrhage
* Recent embolic stroke
* Recent seizure
* Current intracranial mass
* Advanced stage of a neurologic disease that elevates risk for psychosis

Cardiovascular

* Uncontrolled hypertension
* Clinically significant cardiac disease

Respiratory

* Severe pulmonary disease
* Supplemental oxygen requirement

Gastrointestinal

* Current intractable nausea/vomiting/diarrhea
* Recent, clinically significant GI bleed
* Markedly abnormal liver function tests

Endocrine, Renal, and Reproductive

* Pregnancy or lactation
* Severe renal insufficiency
* Unstable insulin-dependent diabetes mellitus

Prohibited Medications

* Antipsychotics (with exceptions)
* Antidepressants (with exceptions)
* Dopamine agonists
* Drugs known to have adverse interactions with psilocybin or ketamine
Resource Intervention to Support Equity (RISE) in High-Risk Neuroblastoma

The goal of this study is to test if the addition of a novel income-poverty targeted supportive care intervention (Pediatric Resource Intervention to Support Equity \[Pediatric RISE\]) to usual supportive care for low-income children with high-risk neuroblastoma can improve parent- and child-centered outcomes.

Participants will be randomized to receive one of the following for 6-months:

* Usual supportive care alone or
* Usual supportive care plus Pediatric RISE

This is a randomized Phase II trial evaluating the addition of the RISE supportive care equity intervention to usual supportive care for poverty-exposed children participants with newly diagnosed high-risk neuroblastoma. Participants will be randomized into one of two groups: Usual supportive care or Pediatric RISE plus usual supportive care. Randomization means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, in-person or virtual appointments, and surveys.

Participation in this research study is expected to last for about 6-months.

It is expected that about 84 participants will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

Patient cohort: The randomized Phase II multi-center RISE intervention will be conducted among a population of poverty-exposed children with high-risk neuroblastoma. Poverty will be a priori defined as parent-reported low-income (\<200% Federal Poverty Level). Children receiving treatment for cancer at study sites will serve as the study cohort, with parents/guardians as survey informants and intervention recipients on behalf of their minor children given that parents (not children) typically manage household finances.

* Patient newly diagnosed with high-risk neuroblastoma
* Patient has established care at study site and initiated cancer-directed therapy
* Patient has not yet initiated Induction Cycle 3
* Patient aged 0-17 years at the time of consent
* Parent/guardian screened positive for self-reported low-income (\<200% Federal Poverty) \*
* Family primary residence in MA, PA, IL, CA, WA, CT, GA, WI and OH
* Both patients co-enrolled on ANBL2131 or those receiving standard of care therapy at their center are eligible to participate
* Patients of all languages are eligible to participate

Exclusion Criteria:

* Foreign national family receiving care as an Embassy-pay patient.
* Child or household member receiving SSI
Prophylactic Application of an Incisional Wound Vac to Prevent Wound Complications in Obese Spine Surgery Patients

This is a prospective randomized study evaluating the use of a prophylactic incision wound vac dressing, applied in the OR, on patients undergoing posterior spine surgery with a BMI\>35. Patients are randomized in the operating room to normal postoperative dressing vs. vac dressing. The vac dressing would be left on for 72 hours postoperatively. In the interim, the patients' postoperative care can proceed as usual. Our primary outcomes will be antibiotics or return trip needed to the operating room for wound related complications.

The patients only intervention would be the application of an incisional wound vac. The will be no change in the patients postoperative protocol otherwise. This procedure is noninvasive.


Eligibility Criteria:
Inclusion Criteria:

* Be scheduled to have posterior spine surgery (inpatient procedures only).
* Have a BMI greater than or equal to 35.

Exclusion Criteria:

* BMI less than 35
* Previous spine infection
* Intraoperative dural tear