cyrilzakka/clinical-trials huggingface dataset:
Agaricus Bisporus and Influenza Vaccination Response

There are numerous in vitro and animal studies that suggested that mushrooms beneficially influence the immune system. We have recently shown that a wild isolate of the edible Agaricus bisporus mushroom had a clear effect on parameters reflecting a better function of the immune system, both in vitro and in vivo in animals. The question now is whether this efficacy can also be translated to humans. In humans, measuring the antibody response is the golden standard to evaluate immune function. If Agaricus bisporus powder indeed has beneficial effects on the immune system, people with overweight or obesity and higher age might benefit from consuming Agaricus bisporus powder prior to receiving the influenza vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Aged 60 years or older during influenza season 2023/2024 (in line with RIVM guidelines)
* BMI between 20 and 35 kg/m2
* Willing to abstain from mushrooms other than the capsules containing a mushroom powder as provided by us during the study period.
* Willing to keep the intake of fish oil, Zinc, Selenium and (vitamin) supplements constant
* Willing to abstain from products / supplements enriched with Vitamin D
* Willing to abstain from products / supplements enriched with plant sterols or stanols
* Willing to abstain from products / supplements enriched with (β)glucans or fungi.
* Willing to abstain from products / supplements that are mentioned to "boost your immune system"
* Willing to abstain from (products enriched in) pre/pro-biotics
* Willing to abstain from products/supplements enriched with ergothioneine

Exclusion Criteria:

* Already received influenza vaccination in 2023
* Allergy to mushrooms
* Known allergic reaction to an active component or other components of the vaccine (e.g. Chicken Eggs)
* Having donated blood within one month prior to the start of the study, or planning to donate blood during the study
* Excessive alcohol use (\>20 consumptions per week)
* Regular use of soft and/or hard drugs
* Using medication for diseases known to affect inflammation/immunity (e.g. inhaled corticosteroids and prednisone)
Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

This is a 8-year extension study in pediatric subjects who have been diagnosed with one of 3 subtypes of Juvenile Idiopathic Arthritis (JIA) \[extended oligoarticular JIA, enthestitis related arthritis (ERA), or psoriatic arthritis (PsA)\] who have completed approximately 96 weeks of participation in study 0881A1-3338 (B1801014). The study contains an active treatment period, withdrawal/re-treatment period and a observational period (non-treatment).


Eligibility Criteria:
Inclusion Criteria:

Receipt of at least 1 dose of investigational product (etanercept) and participation for approximately 96 weeks in study 0881A1-3338 (B1801014)

Personally signed and dated informed consent document (and assent document, as applicable) indicating the subject (or legally representative/guardian) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

Exclusion criteria for subject planning to continue investigational product:

withdrawal from investigational product in study 0881A1-3338 for any reason (safety or non-safety).

History of maliginancy other than squamous cell, basal cell carcinoma or cervical carcinoma in situ.
Safety and Validity of Extracorporeal Fenestration and in Situ Fenestration in Patients With Aortic Disease Involving the Left Subclavian Artery

This trial aims to demonstrate the safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery.


Eligibility Criteria:
Inclusion Criteria:(All of the following criteria were met for enrolment):

1. Patients aged greater than 18 years old and less than 80 years old.
2. Patients diagnosed with thoracic aortic disease, including thoracic aortic dissection, thoracic aortic aneurysm, thoracic aortic ulcer and intramural hematoma.
3. Patients needed endovascular repair (TEVER).
4. Patients who needed complete coverage of the left subclavian artery (planned landing Zone was in Zone 2 of the aortic zone).
5. The proximal lesion involved the proximal aorta within 1.5cm of the posterior edge of the left subclavian artery (LSA) opening, but not the left common carotid artery (LCCA).
6. Suitable femoral artery, iliac artery and brachial artery access can be used for endovascular treatment.
7. The patients could understand the purpose of the study, volunteered to participate in the study, and informed consent was signed by the subjects themselves or their legal representatives.
8. Patients were willing to undergo follow-up evaluation as required by the study protocol.
9. The life expectancy of the patient is more than 12 months.

Exclusion Criteria:(If any of the following criteria is met):

1. The lesion involved the proximal aorta of the LCCA opening (Zone 0 and Zone 1).
2. The patient has a definite connective tissue disease (e.g., Marfan syndrome).
3. The subjects had a history of previous thoracic endovascular aortic repair (TEVAR).
4. Patients who have had or may have had severe allergic reactions to contrast media (anaphylactic shock, exfoliative dermatitis, etc.).
5. Patients with contraindications to antiplatelet and anticoagulant drugs.
6. The patient's compliance was poor and the follow-up could not be expected on time.
7. Patients with acute systemic infection.
8. Patients cannot tolerate general anesthesia.
9. Patients judged by the investigator to be ineligible for endovascular treatment.
Accelerated Rehabilitation in Hip Arthroplasty

Accelerated rehabilitation protocol in Total Hip Arthroplasty (THA-AR).

The accelerated rehabilitation protocol in Total Hip Arthroplasty (THA-AR) was designed to improve the functionality and optimize early discharge of patients undergoing THA surgery. This study compared physical therapy protocol in Total Hip Arthroplasty (THA-PT) already deployed in Porto Alegre Clinical Hospital with THA-AR.

Eligibility Criteria:
Inclusion Criteria:

* Patients of the Public Health System of our Country that were admitted with hip osteoarthritis diagnose and submitted to a total hip arthroplasty surgery in the Hospital de Clínicas de Porto Alegre (HCPA).

Exclusion Criteria:

* Patients who refused to participate in this study;
* Patients lived in another city;
* Patients undergoing surgery for total hip arthroplasty due to hip fracture;
* Patients with cognitive disorders or diseases that adversely affect its cognitive function (Alzheimer's disease, senile dementia).
Sym004 in Subjects With Stage IV Non-small Cell Lung Cancer

This is a multi-center, open-label, Phase 1b, dose escalation trial of Sym004 administered in combination with 1 of 3 platinum-doublets in subjects with Stage IV Non-Small Cell Lung Cancer (NSCLC).

The sponsor decided to discontinue the development of Sym004. Also the decision was made to discontinue the development of Sym004 in NSCLC indication. The decision to discontinue Sym004 in NSCLC was not related to any safety or efficacy findings regarding Sym004. As a result of the early discontinuation of the trial during the dose escalation part, the expansion cohort will no longer be performed hence the pre-specified secondary endpoints are not analyzed and were removed from the protocol based on protocol amendment 2 dated 31 March 2015.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients (except where inpatient stay is required for medical need at the Investigator's discretion) at least 18 years of age at the time of informed consent
* Histologically-confirmed NSCLC Stage IV disease (according to the seventh edition of the lung cancer staging system)
* Eligibility for platinum-based chemotherapy
* Tumor tissue available for epidermal growth factor receptor (EGFR) expression analysis
* Measurable disease defined as 1 or more target lesions according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
* Life expectancy of at least 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Previous therapy for Stage IV NSCLC, or neo- or adjuvant chemotherapy or chemoradiotherapy within the previous 6 months
* Previous investigational drug or any anticancer therapy in the 30 days (or 5 half-lives for non-cytotoxics, whichever is shorter) prior to the start of trial treatment
* In countries where anaplastic lymphoma kinase (ALK) inhibitors are available for the treatment of NSCLC, subjects need to have been screened for ALK fusion gene rearrangements and excluded if positive, unless previously treated and progressed on an appropriate tyrosine kinase inhibitor (TKI) therapy
* In countries where EGFR TKIs are available for the treatment of NSCLC, subjects need to have been screened for EGFR mutations and excluded if positive, unless previously treated and progressed on an appropriate TKI therapy
* Concurrent chronic immunosuppressive or hormone anticancer therapy (except other physiologic hormone replacement)
* Known brain metastases (unless asymptomatic and treated) or leptomeningeal metastases, including suspected leptomeningeal spread with positive cytology
* History of any other malignancy within 5 years (except basal cell carcinoma of the skin or carcinoma in situ of the cervix)
* Other protocol defined exclusion criteria could apply
Online Information and Support for Distance Caregivers

This study seeks to test the effectiveness of two arms of an intervention that use videoconference technology for distance caregivers of patients with advanced cancer. The study is significant because the intervention will promote involvement of caregivers of patients with cancer and makes a compelling case for significance based on changing demographics and lifestyles.

The primary goal of this randomized clinical trial is to compare outcomes (anxiety, distress, depression, health status) for distant care givers (DCGs) of patients with advanced cancer who are randomly assigned to either the full intervention arm (Closer), the video-only intervention arm (Video-C Only) or the control group (Web-Only). the goal is to determine which is most efficacious in improving outcomes over time for these caregivers. In addition, this study will examine the indirect effects of each arm of the intervention on DCG outcomes over time as well as explore the nature of relationships between patient and DCG distress, anxiety and depression over time.

The specific research questions include:

1. Is there a difference in DCG outcomes (anxiety, distress, depression, health status) over time between caregivers in the Closer, Video-C Only, and Web-Only groups, controlling for DCG demographic variables?
2. Are there significant indirect effects of Closer, Video-C Only, and Web-Only on DCG outcomes (anxiety, distress, depression, health status) over time, controlling for DCG demographic variables?
3. Are there significant relationships between DCG distress, anxiety, depression and health status and patient distress, anxiety and depression over time?

Eligibility Criteria:
Patient Inclusion Criteria:

* a new diagnosis (within 3 months) of advanced cancer and/or patients receiving ongoing care from a medical oncologist (solid tumors) or a new recurrence of the primary cancer in an advanced stage
* receives ongoing care from a medical oncologist at the Seidman Cancer Center
* Has English as the primary language
* Has a life expectancy of \>6 months
* Provides consent for his/her own treatment and procedures
* Identifies a distant care giver (DCG) involved in his/her care, support or planning

Patient Exclusion Criteria:

* The patient sample is limited to patients with advanced cancer and/or patients receiving ongoing care from a medical oncologist because the full intervention is tailored to meet the needs of DCGs of patients with advanced cancer and/or patients receiving ongoing care from a medical oncologist

Caregiver Inclusion Criteria

* Is an adult family member (at least 18 years old) of a patient with an advanced-stage cancer
* Identifies himself/herself as a DCG for the patient
* Lives \>1 hour travel time away from the patient
* Has English as his/her primary language
* Is capable of providing informed consent
* Will be able to access the internet (phone, computer, etc.)

Caregiver Exclusion Criteria

* Cognitive Impairment
To Evaluate the Efficacy of ZOMETA® in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer

The purpose of this study is to assess the efficacy of addition of zometa to anti-neoplastic treatment compared with anti-neoplastic treatment alone, as measured by the primary efficacy variable of SREs (Skeletal Related Events) and to assess the safety in nasopharyngeal patients with bone metastases randomized to receive either zometa 4 mg or anti-neoplastic treatment alone.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18, either sex
* Histologically confirmed stage IV nasopharyngeal cancer
* One bone metastasis at least confirmed by imaging
* without chemotherapy or radiotherapy after bone metastasis
* Life expectancy \> 6 M
* ECOG \<= 2
* Adequate bone marrow reserve (WBC \> 3.5 x 109/L, Neutrophile \> 1.5 x 109/L, Platelet 100 x 109/L, Hb \> 90 g/L)
* Serum creatinine\< 2.0 mg/dL (\< 1.5 times the upper limit of the normal range for the laboratory of the study center)
* Signed ICF

Exclusion Criteria:

* Women who are pregnant or in lactation
* Patients with hyperostosis
* Systemic treatment for another cancer within the year prior to study entry
* Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
* Initial serum creatinine \>265 micromol/L and/or progressive renal disease
* Known hypersensitivity to any of the study drugs or to drugs with similar chemical structures
* Use of investigational agents within 28 days of the Baseline visit, or participating simultaneously in any other clinical studies
* Severe co-morbidity of any type that may interfere with assessment of the patient for the study
Standard Non Operative Treatment Versus Accelerated Rehabilitation of Achilles Tendon Ruptures

The purpose of this study is to directly compare traditional plaster treatment with early weightbearing in a walking boot for the non operative treatment of acute achilles tendon rupture.

This injury has traditionally been treated in a plaster cast applied to the leg for a period of 10 weeks which allows the tendon to heal, or by an operation to repair the tendon. Research undertaken in the investigators department has shown that patients treated with surgery or with a plaster had similar chance of re-rupture of the tendon after treatment and gain a similar recovery. The investigators therefore now manage these injuries in a plaster.

More recently, further research has shown that a new type of non-surgical rehabilitation programme, which is quicker than the traditional non-surgical programme, gave a tendon re-rupture rate that was similar to that after surgical treatment. This new rehabilitation programme uses a walking boot fitted with a heel-raise (instead of the traditional plaster). The potential benefit of this quicker rehabilitation programme is that it allows the patient to put weight through the leg immediately, whereas patients treated with the traditional plaster cast non-surgical treatment cannot weight bear (this means that they are kept non-weightbearing and therefore have to use crutches) for the first 8 weeks. The time spent in the walking boot in this new, quicker rehabilitation programme is 8 weeks while that spent in plaster is 10 weeks. This new non-surgical, quicker rehabilitation programme is referred to as the accelerated non-surgical programme hereafter. There are no known increased risks with the accelerated rehabilitation programme.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 16-60 years old with an acute rupture of the Achilles tendon

Exclusion Criteria:

* Patients who do not have an acute rupture (ie. delayed presentation \>2 weeks)
* Patients who present with a re-rupture of a previously treated Achilles tendon
* Patients from outside the Lothian (local treatment) area who are unwilling to attend follow-up at the study institution.
* Latex allergy.
Feasibility of One-Step Sentinel Lymph Node (SLN) Biopsy With Radiolabeled Methylene Blue (IND 70,627)

The purpose of this study is to develope a one-step procedure to perform a biopsy of axillary lymph nodes on the same side as the breast tumor in women diagnosed with breast cancer.

This study proposes the use of a newly developed experimental radioactive dye (radiolabeled methylene blue). On the day of surgery, the patient receives a single injection of the experimental radioactive dye after anesthesia. The injection will be in the location around the breast tumor. The surgeon makes a small cut in the armpit on the side of the cancer and is able to locate the lymh nodes that collect drainage from the cancerous area by detecting lymph nodes with higher radioactivity using a hand-held detector (a Geiger counter-like device) and/or visually identifying lymph nodes stained blue by the dye. These lymph nodes are then removed and analyzed by pathologists for the presence of cancer.

Eligibility Criteria:
Inclusion Criteria:

* Stage 0,I, II breast cancer
* Clinical node status N0, N1
* No know allergy to iodine, lymphazurin or methylene blue dyes

Exclusion Criteria:

* Patient cannot be pregnant or nursing
* Prisoners will not be eligible
* Women under the age of 18 will not be eligible
* Patients with a known allergy to iodine or methylene blue or lymphazurin blue dyes
Value of Digital Breast Tomosynthesis in Breast Lesions

The aim of the study is to evaluate the added value of digital breast tomosynthesis (DBT) in the characterization of breast lesions.

All patients enrolled in the study will undergo both 2D digital mammography and digital breast tomosynthesis (DBT), using standardized protocols. The DM plus DBT acquisition commonly referred to as "combo" mode , that has shown an improvement in specificity and sensitivity , but at approximately doubling of the radiation dose . This approach will provide a consistent framework for evaluating the diagnostic capabilities of both techniques in characterizing breast masses.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with mammographic breast lesions of BIRADS III, IV.
2. Dense breast in patients with complaints (BIRADS 0) which needed further assessment.

Exclusion Criteria:

1. Pregnant females to avoid the hazards of ionizing radiation to the fetus.
2. Patients with known metastatic breast cancer.
Platelet Rich Plasma Combined with Platelet Rich Fibrin in Management of Temporomandibular Joint Osteoarthritis

Studying effectiveness of prp with prf comparing with prp or prf for mangement of tmj osteoarthritis as result in pain and mandibular movement in adult pt

45 pt assigned for the study , divided in to three gruops to comparing new combination of prp with prf in management of TMJ OA

Eligibility Criteria:
Inclusion Criteria:

Adult pt with OA

Exclusion Criteria:

Medicaly compromised
A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172)

The purpose of this study is to determine the rate and frequency of high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select adverse events in subjects with histologically confirmed stage III (unresectable) or stage IV melanoma and progression post prior treatment containing an anti-Cytotoxic T Lymphocyte Antigen (CTLA-4) monoclonal antibody, treated with Nivolumab (BMS-936558) at a dose of 3 mg/kg every two weeks.


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

Inclusion Criteria:

* Subjects with histologically confirmed malignant melanoma
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS):

  * PS 0 to 1
  * PS 2
* Previously treated unresectable stage III or stage IV melanoma as per the American Joint Committee on Cancer 2010 Guidelines regardless of BRAF mutation status
* Subjects must have experienced evaluable Response Evaluation Criteria In Solid Tumors (RECIST 1.1)-defined disease progression
* Prior treatment with chemotherapy, interferon (adjuvant setting), Interleukin (IL-2), BRAF/MEK inhibitors for subjects with known BRAF mutations, Mitogen-activated or extracellular signal- regulated protein kinase (MEK) inhibitors for Neuroblastoma Ras Viral (v-ras) oncogene homolog (NRAS) mutations, and cKIT inhibitor subjects with known cKIT mutations are allowed
* Patients with CNS metastases are eligible:

  * if CNS metastases are treated, patients are asymptomatic or neurologically returned to baseline
  * if they have previously untreated CNS metastases and are asymptomatic
  * if they have leptomeningeal metastases, are treated and asymptomatic or neurologically returned to baseline with life expectancy \> 3 months
* Patients with a known history of Grades 3-4 immune-related adverse reactions during/after anti-CTLA-4 therapy if all toxicities have resolved at least to Grade 1

Exclusion Criteria:

* Subjects with untreated, active Central Nervous System (CNS) metastases are excluded
A Study to Evaluate the Safety of Long-term Ivacaftor Treatment in Participants With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation

This is a Phase 3, 2-arm, multicenter study with an open-label ivacaftor arm and an observational arm to evaluate the safety and efficacy of long-term ivacaftor treatment in participants with cystic fibrosis (CF) who are \<24 months of age at treatment initiation and have an approved Ivacaftor-Responsive mutation.


Eligibility Criteria:
Inclusion Criteria:

Ivacaftor Arm: Participants From Study 124 (NCT02725567 ) Part B:

* Participants transitioning from Study 124 Part B must have completed the last study visit of Study 124 Part B.
* As judged by the investigator, parent or legal guardian must be able to understand protocol requirements, restrictions, and instructions; and must sign the informed consent form (ICF).

Ivacaftor Arm: Participants Not From Study 124 Part B:

* Confirmed diagnosis of CF, or 2 CF-causing mutations.
* An ivacaftor- responsive CFTR mutation on at least 1 allele. Participants will be eligible in countries/regions where ivacaftor is approved for use in participants 2 years of age and older.
* As judged by the investigator, parent or legal guardian must be able to understand protocol requirements, restrictions, and instructions; and must sign the ICF.

Observational Arm:

* Received ivacaftor treatment in Study 124 Part B and elected not to enroll or ineligible to enroll in the ivacaftor arm of Study 126.

Exclusion Criteria:

Ivacaftor Arm: Participants From Study 124 Part B:

* History of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering ivacaftor to the participant.
* Participants receiving commercially available ivacaftor treatment

Ivacaftor Arm: Participants Not From Study 124 Part B:

* History of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering ivacaftor to the participant
* An acute upper or lower respiratory infection, or pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks of Day 1
* Abnormal liver function at screening
* Hemoglobin \<9.5 g/dL at screening
* History of solid organ or hematological transplantation
* Use of any moderate or strong inducers or inhibitors of CYP3A within 2 weeks of Day 1

Observational Arm:

* Receiving ivacaftor treatment

Other protocol defined Inclusion/Exclusion criteria may apply.