cyrilzakka/clinical-trials huggingface dataset:
Radiation Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Receiving Sipuleucel-T

This pilot clinical trial studies the impact of radiation therapy on the immunogenicity of Sipuleucel-T. Patients with castration recurrent prostate cancer who are eligible for treatment with Sipuleucel-T and who have bone metastases are eligible.

PRIMARY OBJECTIVES:

I. To assess whether radiation therapy (RT) increases the immunogenic potential or sipuleucel-T in participants with castration recurrent prostate cancer.

II. To assess systemic changes to the immune system and genetic changes to immune cells in participants treated by the combination of RT and sipuleucel-T.

III. To assess the induction of antigen-specific immune responses to prostatic acid phosphatase (PAP), cancer/testis antigen 1B (NY-ESO-1) and antigens that have proven to be released by radiation (such as, heat shock protein 90 \[HSP-90\], calreticulin, etc.).

SECONDARY OBJECTIVES:

I. To assess adverse event rates in participants receiving the high-dose radiation and sipuleucel-T therapy.

II. To assess prostate-specific antigen (PSA) changes. III. To assess overall and cancer specific survival.

OUTLINE:

Patients undergo single-fraction radiation therapy to at least 1 bone lesion 2 days after the first sipuleucel-T dose.

After completion of study treatment, patients are followed up at 3 and 6 months and then annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Have minimally symptomatic metastatic castration recurrent prostate cancer with bone lesions; this patient population is defined as having failed hormone treatment and has insurance approval for PROVENGE® therapy
* Patients that have been prescribed sipuleucel-T and have not started treatment
* Must be candidates for radiation treatment to bone lesions
* Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2

Exclusion Criteria:

* Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
* Patients who have received prior radiation of osseous lesions
* Patients who have received any prior immunotherapy
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the patient an unsuitable candidate
Hospital-based Home Care for Children With Cancer

The purpose of this non-randomized controlled intervention study was to evaluate the effects of a hospital-based home care program for children with cancer at a university hospital in Denmark. The hypothesis was that hospital-based home care could replace an out-patient visit or an in-patient admission without increasing the incidence of adverse events and costs. Furthermore, to enhance the children's quality of life and the psychosocial impact on the family.

Hospital-based home care for children with cancer is widely used but controlled studies are relatively rare and the evidence base is limited. This prospective non-randomized controlled intervention study aimed to evaluate hospital-based home care for children with cancer.

A hospital-based home care program was conducted August 2008 - December 2009. Participants were children with cancer and their parents. The intervention group received part of their therapy, such as intravenous chemotherapy and antibiotics, as home care by a hospital-based home care nurse with paediatric-oncology experience. Children in the control group received all their treatment at the hospital.

Fifty-one children between 0 and 18 years were included in the home care program, and 47 children were included in the control group. After each home visit the parents answered a questionnaire. The results from 657 questionnaires showed that 100% were very satisfied or satisfied with home care and all would choose home care again, if offered as an option. There were no deaths or adverse effects of intravenous chemotherapy or antibiotics. A cost analysis based on the expenses associated with home care in correlation with standard cost of inpatient admissions and outpatient visits showed that the hospital-based home care programme was economically equal. The children's and the families' quality of life may be enhanced. The results indicate that the hospital-based home care program is safe, economically neutral and the parents' satisfaction with the program is major.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cancer
* First-line treatment with intravenous therapy with a curative intent
* Have not received a haematopoietic stem cell transplantation
* Child and parent(s) speak and read Danish

Exclusion Criteria:

* End-of-life treatment
* Critical medical condition
Prediction and Intervention in Developmental Dyslexia

The long-term goal of this study is to improve prediction of poor reading outcome at preschool age by using a combination of behavioural and neuroimaging measures and to evaluate a specific computerized training program to support children with problems during reading acquisition.


Eligibility Criteria:
Inclusion Criteria for all groups:

* Healthy, native (CH-) German speaking subjects, with an estimated non-verbal intelligence quotient (IQ) \>=80, without neurological and/or psychiatric disorder (except for attention deficit hyperactivity disorder, specific learning disorders, developmental language impairments)
* Additional criteria for subgroups:
* Recruitment of preschoolers (aged 5.5-7.5 years):
* Healthy children with increased risk for developmental dyslexia in their second year at kindergarten
* Recruitment of children in first grade (aged 6.5-8.5years):
* Children showing impairments in learning to read (first/second grade).
* Adults (aged 20-40 years):
* Healthy, normal reading

Exclusion Criteria for all groups:

* MRI contraindications
* No history of premature delivery and/or maternal reports of severe prenatal, perinatal or postnatal complications.
Prospective Observational Lymphoedema Intensive Treatment

The aim of this observational study was to describe usual practices in lymphedema management in France.

It was the opportunity to assess the effects of these practices on lymphedema volume in a large number of patients, to identify predictive factors of response, and to assess the safety of this therapy.

Lymphoedema is commonly treated according a strategy called Complex Decongestive Therapy (CDT). This CDT is usually composed of 2 different treatment phases. The first phase is an acute phase which aim is to reduce affected limb volume. The second phase is a maintenance phase which aim is to maintain as long as possible the volume reduction acheived during the first phase.

These 2 phases required multi modal parameters such as bandages, lymphatic drainages, physical exercises...and can be managed very differently from one site to another.

Eligibility Criteria:
Inclusion Criteria:

* consecutive adult patients
* hospitalized with a clinical diagnosis of unilateral stage II-III upper or lower limb lymphoedema of any etiology
* indication for intensive decongestive therapy (IDT)

Exclusion Criteria:

* bilateral lymphedema,
* lymphedema of both upper and lower limbs,
* intensive decongestive therapy in the previous 6 months,
* cancer recurrence,
* systolic pressure index \< 0.5
Safety Study of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis

To assess the safety of treatment with pirfenidone (up to 3600 mg/d) in patients with pulmonary fibrosis/idiopathic pulmonary fibrosis (PF/IPF).

This study has been designed as a rollover study to collectively include safety data from various previous studies.

In addition, InterMune has also initiated an Early Access Program to make pirfenidone available to a limited number of patients with idiopathic pulmonary fibrosis in the United States. This program is also being conducted under this protocol. Registration of patients with documented IPF has been closed as of October 2005.

Eligibility Criteria:
General Inclusion Criteria:

* Able to understand and sign an informed consent form
* Understand the importance of adherence to study treatment and the study protocol, including concomitant medication restrictions, throughout the study period
* Patients must be willing to travel to an approved regional center for all study-related visits

Roll-Over Criteria:

* Entry into study through rollover has been completed

Criteria for Early Access Program patients:

* Clinical symptoms consistent with IPF ≥3 months duration
* Age 40 - 85, inclusive
* At the time of registration with National Organization for Rare Disorders (NORD), patients with IPF must have a percent predicted forced vital capacity (FVC) of ≥50%, and percent predicted carbon monoxide diffusing capacity (DLCO) of ≥35%
* At the time of enrollment in PIPF-002, (screening/baseline visit) percent predicted FVC must be ≥45%, and percent predicted DLCO must be ≥30%
* High-resolution computed tomographic scan (HRCT) showing definite IPF. For patients with surgical lung biopsy showing definite or probable usual interstitial pneumonia (UIP), the HRCT criterion of probable IPF is sufficient
* For patients aged \<50 years: open or video-assisted thoracoscopic (VATS) lung biopsy showing definite or probable UIP. In addition, no features supporting an alternative diagnosis on transbronchial biopsy or bronchoalveolar lavage if performed
* For patients aged ≥50 years: at least one of the following diagnostic findings as well as the absence of any features on specimens resulting from any of these procedures that support an alternative diagnosis: 1) Open or VATS lung biopsy showing definite or probable UIP; 2) Transbronchial biopsy showing no features to support an alternative diagnosis; 3) Bronchoalveolar lavage (BAL) showing no features to support an alternative diagnosis
A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study

This was a multicenter, open-label extension study. Patients who received vismodegib (GDC-0449) in a Genentech-sponsored study and who had completed the parent study or who continued to receive vismodegib at the time the parent study closed were eligible for continued treatment in this protocol.


Eligibility Criteria:
This study only enrolled participants who took part in previous studies of vismodegib conducted by Genentech.

Inclusion Criteria:

* Completed vismodegib treatment within 2-4 weeks in a Genentech-sponsored parent study or continued to receive vismodegib at the time the Genentech-sponsored parent study closed.
* Expectation by the investigator that the participant may continue to benefit from additional vismodegib treatment.

Exclusion Criteria:

* Intervening anti-tumor therapy not specified in the parent study (ie, non-protocol-specified chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy).
Predictive Value of Revised Trauma Score(RTS)and Glasgow Coma Scale (GCS)of Mortality in Patients with Multiple Trauma.

This study aims to assess the efficacy of RTS and GCS in predicating the mortality among multiple trauma patients admitted to emergency departments at Assiut university hospital.Which score is better in predicting mortality in polytrauma patients Revised Trauma Score (RTS) or Glasgow Coma Scale (GCS) of with Multiple Trauma?

Trauma is a serious global health problem. Globally around 5.8 million people deaths were estimated from injuries in 2004. These deaths accounted for 10% of the world's mortality\[1\]. It is the fifth leading cause ofsignificant, disability and sixth leading cause of death\[2\]. More than 90% of the world's injury deaths occur in low- and middle-income countries\[3\]. Injury deaths in Egypt accounted for 8% and the eighth leading cause of death in 2010\[4\]. There was an increase in the number of hospitalization due to trauma. In Upper Egypt, trauma cases increased from 19,869 up to 32,699 with death rate 1.2/100 cases per year throughout the period from 2002 to 2009.In multiple trauma patient management, time is crucial. Early intervention has consistently been shown to reduce mortality and morbidity\[5\]. Prompt and effective care \[6\]. These scores either measure the alteration in patient's physiology; Glasgow Coma Scale (GCS) and Revised Trauma Score (RTS) or anatomy; Injury Severity Score (ISS)\[7\]. Glasgow Coma Scale (GCS) is one of the most commonly used trauma scores and is a good predictor of the outcome. The GCS is primarily utilized to evaluate the level of consciousness impairment in patients, achieved through the assessment of ocular, motor, and verbal response\[8\].The Revised Trauma Score (RTS) are considered the most practical and effective \[9\].The RTS stands out because it can be quickly calculated using a patient's initial clinical status and vital signs at presentation, making it particularly useful during the critical "golden hour" after arrival\[10\]

Eligibility Criteria:
Inclusion Criteria:

* 1-patients aged from \> 18 years old. 2-Both male and female. 3-Patients have penetrating and blunt trauma.

Exclusion Criteria:

* 1-Pregnant women. 2-Patients with mild trauma such as soft tissue damage and 3-isolated limb fractures. 4-Patients were transferred to another hospital. 5-Failure of follow-up for any reason. 6-Patients who refused participatioc.
A Phase 1 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Recurrent Malignancies

The purpose of this study is to determine the safety and effectiveness of MDX-1106 in patients with certain types of cancer. Another purpose is to determine how MDX-1106 is absorbed and distributed within the body, and how it's eventually eliminated.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Subjects must have mCRPC,RCC, MEL, Non-small-cell lung cancer (NSCLC), or Colorectal Cancer (CRC), that is advanced (non-resectable), or recurrent and for which no alternative, curative standard exists
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
* Must have at least 1 measurable lesion
* Subjects with mCRPC and with only non-measurable bone lesions must have either progression new lesions or have Prostate-specific antigen (PSA) progression within the 6-week period before study administration
* At least 1 and up to 5 prior systemic therapies for advanced/recurrent disease
* Prior treated brain or meningeal metastases must be without Magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks and off immunosuppressive doses of systemic steroids for at least 2 weeks before study drug administration
* Prior systemic radiation therapy must have been completed at least 4 weeks before study drug administration. Prior focal radiotherapy completed at least 2 weeks prior to study drug administration
* Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids must be discontinued at least 2 weeks before study drug administration
* Prior surgery that required general anesthesia must be completed at least 2 weeks before study drug administration. Surgery requiring local/epidural anesthesia must be completed at least 72 hours before study drug administration

Exclusion Criteria:

* History of severe hypersensitivity reactions to other Monoclonal antibody (mAb)s
* Subjects with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy
* Prior therapy with an anti-Programmed death-1 (PD-1), anti-PD-L1, anti-PD-L2, or anti- Cytotoxic t-lymphocyte antigen-4 (CTLA-4) antibody (or any other antibody targeting T cell co-stimulation pathways)
* Known history of Human Immunodeficiency Virus
* Active infection requiring therapy, positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA)
* Underlying medical conditions that will make the administration of study drug hazardous
* Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids
* Use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration
Pilot Evaluation of Hospice Decision Support Tools

The goal of this project is to determine the feasibility and acceptability of a hospice decision aid among a diverse population of older adults at multiple stages of illness (Aim 1) and to determine the preliminary efficacy of the hospice decision aid on decision quality, hospice knowledge, and values-concordance (Aim 2). By testing the feasibility, acceptability, and preliminary efficacy of a novel hospice Patient Decision Aid (PTDa) in a diverse population of older adults, additionally the study will simultaneously explore barriers to PtDA implementation in both an outpatient primary care and inpatient palliative care setting. The study will also gather sufficient pilot data to support a subsequent effectiveness/implementation trial and thus address the absence of quality of SDM interventions for end-of-life care decision-making.


Eligibility Criteria:
Inclusion Criteria:

* 65 or older.
* At least one life-limiting illness or syndrome.

Exclusion Criteria:

* Non-English speakers.
* Patients with cognitive Impairments preventing ability to provide informed consent.
* Patients on isolation precautions due to resistant bacteria or impaired immune function.
Human Gut Microbiota and Prebiotic Response

This study is designed to examine the shift in gut microbiota and their metabolism after consumption of a dietary supplement (prebiotic) by healthy participants. The investigators will provide participants with a panel of over the counter prebiotics and monitor their gut microbiome response in stool. All prebiotics will be commercially available, over-the-counter food, food additives, or dietary supplements, without any known market-use adverse effects beyond minimal discomfort.


Eligibility Criteria:
Inclusion Criteria:

* Provide Stool Samples at no risk to yourself

Exclusion Criteria:

* No oral antibiotic treatments within previous 1 month
* No known allergy to milk products or lactose intolerance
* no known allergy to wheat or gluten intolerance
* no history of irritable bowel syndrome
* no history of inflammatory bowel disease
* no history of type-2 diabetes
* no history of chronic kidney disease or reduced kidney function
* no current intestinal obstructions
* no current untreated colorectal cancer
* not currently pregnant or breastfeeding
Mixed Methods Study Protocol_Chronic Pain and Marginalized Populations

A mixed-methods sequential explanatory design study. The first quantitative phase will be a multi-language survey that includes questions related to pain status, patient beliefs, pain interference/social support, and perspective on healthcare utilization. Latent class analysis (LCA) will be used to generate experience-based subgroups in CMP. The second qualitative phase will use focus group will elucidate, confirm, and more richly describe the findings from the first phase.

Background: The global epidemic of chronic musculoskeletal pain (CMP) is an intractable issue adversely impacting gross domestic products and costing billions in lost productivity. The expansion of CMP occurs concurrently with historical global mass population movements. Geopolitical negative and racist rhetoric have arisen in response to increased immigration rates. CMP is an invisible disease decoupled from normal tissue healing and results from the complex interplay of biological and psychological processing. Different theoretical models of CMP development now include potential demographic and socio-cultural factors. CMP occurs disproportionately in populations at risk for marginalization, including women, non-Caucasians, immigrants, and people experiencing increased socioeconomic deprivation. The same marginalized populations also are at greater risk for limited access to healthcare and demonstrate worse functional limitations, outcomes, and quality of life. Aims: The primary aims are 1) to characterize self-reported features in people who have CMP and experience marginalization and 2) to interpret the pain experience for marginalised populations of people who have CMP. Methods: A mixed-methods sequential explanatory design study will be used. The first quantitative phase will be a multi-language survey that includes questions related to pain status, patient beliefs, pain interference/social support, and perspective on healthcare utilization. Latent class analysis (LCA) will be used to generate experience-based subgroups in CMP. Focus group will elucidate, confirm, and more richly describe the findings from the first phase. Discussion: Results from this study will be used to inform clinical conversations with patients who have CMP and experience marginalization. By increasing awareness of the potential influences on the clinical conversation, we hope to build opportunities to address inequities in CMP management.

Eligibility Criteria:
Inclusion Criteria:

* English, Spanish, and Arabic-speaking adults living in the Piedmont Triad, NC

Exclusion Criteria:

* declined to participate
Mobile Health Intervention to Support Healthful Diet

This will be a pilot clinical trial to evaluate preliminary efficacy of a newly designed mobile intervention designed to support healthy eating in old people. The main scientific premise of this project is that mobile approaches are feasible for behavioral and metabolic improvements in the population of people 65+ with mild-to-moderate frailty. Specific Aim of this project is to describe feasibility, acceptability and initial efficacy of the newly designed mobile intervention in a pilot RCT. The pilot RCT, comparing usual care to usual care plus mobile intervention, will provide data on the sensitivity of outcome measures and estimated effect size to inform a larger RCT. Primary outcomes for the pilot RCT will include change in adherence to Mediterranean diet (MedD) score, change in insulin sensitivity measures, feasibility and acceptability. Secondary outcomes include MedD knowledge, self-efficacy, outcome expectation, self-regulation, social support, platform use and anthropometric and functional measures.


Eligibility Criteria:
Inclusion Criteria:

Age 65+

Mild to moderate frailty

Suboptimal diet

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Exclusion Criteria:

1. Dependence in activities of daily living
2. Memory Impairment
3. Hearing or visual impairment
4. Unusual dietary restrictions