cyrilzakka/clinical-trials huggingface dataset:
Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry)

This registry seeks to prospectively gather a large repository of comprehensive observational data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy, in order to assess clinical response in a real-world setting and further validate the safe and appropriate use of SIR-Spheres

This is a global, multi-center, prospective, observational cohort study (registry) to assess real-world outcomes in patients with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy who have been prescribed SIRT with SIR-Spheres per medical decision.

The study will be conducted through the involvement of approximately 845 patients from up to 44 sites in an estimated 10 countries.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Confirmed diagnosis of:
* Unresectable hepatocellular carcinoma (HCC) Or
* Unresectable liver metastases from colorectal cancer (mCRC) refractory to or intolerant to chemotherapy
* Identified as a candidate for SIR-Spheres treatment as deemed appropriate during the normal course of practice
* Planned to receive SIR-Spheres treatment to the liver for the first time
* Provision of signed patient informed consent

Exclusion Criteria:

* Prior radiation treatment to the liver

Caveat:

Sequential selective internal radiation therapy (SIRT) treatment is allowed

* Patients participating in any interventional clinical trial with an investigational product, device, or procedure
* Need for surrogate consent. Patients who are not able to consent on behalf of themselves are not eligible.
Endobronchial Diagnosis of Lymphoma

The present study aimed to assess the diagnostic performance of ultrasound-guided endobronchial intra-nodal miniforceps biopsy (EBUS-MFB) in the diagnosis of "de novo" mediastinal lymphoma.

Every patients will be sampled using both EBUS-MFB and the standard of care EBUS-TBNA (transbronchial needle aspiration).

It is a monocentric investigation. Pathologist will not know the way of sampling while analysing the samples

Eligibility Criteria:
Inclusion Criteria:

* Pathological mediastinal nodes within reach of EBUS sampling on CT-scan.
* Lymphoma suspicion by a senior clinical hematologist
* Affiliated to the french public health care insurance

Exclusion Criteria:

* Peripherical pathological lymph nodes reachable without general anesthesia
* Antithrombotic medication that cannot be stopped le time of the procedure.
* Unstable respiratory status
* History of lymphoma
* Latex or xylocaine allergia
Dual Add-on Therapy in Type 2 Diabetes Poorly Controlled With Metformin Monotherapy

2 weeks screening period, 4 weeks run-in period, 24 weeks double-blind treatment period, to evaluate the Safety and Efficacy of Retagliptin Plus Henagliflozein added to Metformin compared to Retagliptin or Henagliflozein in combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone


Eligibility Criteria:
Inclusion Criteria:

1. Men and women, 18-75 years old (both inclusive) at time of screening visit;
2. Subjects with T2DM with inadequate glycemic control defined as central laboratory HbA1c ≥ 7.5 and ≤ 10.5 % at the screening visit;
3. FPG ≤ 15mmol/L at the screening visit;
4. Stable metformin therapy for at least 8 weeks prior to screening at a dose ≥ 1500 mg per day;
5. 19.0\<BMI ≤ 40.0 kg/m2 at the screening visit;

Exclusion Criteria:

1. Moderate or severe impairment of renal function \[defined as eGFR\<60mL/min/1.73 m2 (estimated by MDRD);
2. Uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg;
3. Cardiovascular diseases within 6 months of the screening visit;
4. ALT and/or AST \> 1.5 x ULN and or Total Bilirubin \> 1.2 x ULN;
5. Hemoglobin ≤ 100 g/L;
6. CK (creatine kinase) and CK-MB \> 3 x ULN;
7. Malignancy within 5 years of the screening visit (with the exception of treated basal cell or treated squamous cell carcinoma);
8. Administration of any antihyperglycemic therapy, other than metformin,within 2 months prior to screening;
Hemi-Gland Cryoablation for Prostate Cancer at UCLA

This is a prospective data collection of men who are electing to undergo prostate hemi-gland cryoablation.

The purpose of this observational research study is to investigate the localized treatment of prostate cancer using hemi-gland cryoablation.

UCLA patients undergoing hemi-gland cryoablation are a unique cohort compared to prior research because all patients at UCLA have had a pre-treatment multi-parametric MRI and Ultrasound fusion targeted biopsy; they will be followed in a similar fashion. This results in more precise assessment of a target region of cancer for ablation which may, in turn, result in improved clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patient has undergone or has elected to undergo hemi-gland cryoablation at UCLA
* Low or intermediate risk prostate cancer (Gleason ≤ 7) or select high-risk patients (Gleason 8 prostate cancer).
* Prostate volume of ≤ 70 cc
* Ability to complete informed consent form

Exclusion criteria:

* Medical contraindication to follow-up multi-parametric magnetic resonance imaging (mpMRI) or prostate biopsy
* Patients unable to tolerate general or regional anesthesia.
Study of Tau Imaging With the Use of [18F]MK-6240 Tracer

The recent development of a PET tracer,\[18F\]MK-6240(an\[18F\]tau imaging agent,CerveauTechnologies)that has high affinity for the human phosphorylated tau deposits in AD brain offers new opportunities to investigate tau pathology. The investigators will evaluate this imaging agent in individuals from families with a known Autosomal Dominant Alzheimer's Disease (ADAD) mutation. This study of tau PET using \[18F\]MK-6240 is performed in conjunction with DIAN and DIAN Extended Registry (DIAN-EXR).


Eligibility Criteria:
Inclusion Criteria:

1. Participants have met all eligibility criteria for enrollment into the Dominantly Inherited Alzheimer's Network (DIAN) and DIAN Extended Registry (DIAN EXR) study enrollment criteria.
2. Male or female participants, at least 18 years of age.
3. Cognitively normal, or with mild dementia, as assessed clinically.
4. Participant is able and willing to undergo testing (magnetic resonance imaging (MRI)or computed tomography (CT), PET, radioactive tracer injection; forthose unable to undergo MRI, CT will be used to generate regions-of interest).
5. Pre-menopausal women will undergo a urine pregnancy test within 24 hours of drug administration. -

Exclusion Criteria:

1. Has any condition that, in the Investigator's opinion, couldincrease risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severechronic back pain might not be able to lie still duringthe scanning procedures).
2. Is deemed likely unable to perform the imaging procedures for any reason.
3. Has hypersensitivity to \[18F\]MK-6240or any of its excipients.
4. Contraindications to PET, PET-CT or MR(e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate.
5. Severe claustrophobia.
6. Women who are currently pregnant or breast-feeding, and women who do not agree to use reliable contraception, or to refrain from sexual activity for 24 hours following administration of the \[18F\]MK-6240injection will be excluded from the study.
7. Currently participating in any research studyreceiving an active study medication for AD, an investigational drug, device, imaging, or placebo within the past 30 days before screening, and throughout this clinical trial up to 2-weeks past any study-related procedures.
8. Other than the DIAN study, current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the US Code of Federal Regulations (CFR) Title 21 Section 631.1. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1. It is the responsibility of each site to confirm the date of the most recent PET scan and to work within the guidelines of the local Radioactive Drug Research Committee (RDRC) regarding the imaging interval. -
Reliability of the Freestyle Libre CGM in the Inpatient Setting During the COVID-19 Surge

The FDA has provided an emergency waiver for the use of non-invasive continuous glucose monitors (CGM) in hospitals, so frontline health care providers (in hospitals) can remotely monitor patients with diabetes thus reducing patient's discomfort, limiting exposure to COVID-19 and preserving critical personal protective equipment (PPE). The FreeStyle Libre 14-day system is a continuous glucose monitoring system consisting of a handheld reader (smart phone may be used) and a sensor applied with adhesive to back of the upper arm. In order to evaluate the reliability of the Freestyle Libre CGM for in-patient use, we propose a study which will examine the correlation between the libre CGM data and capillary blood glucose test - the current standard of care taken by the Accuchek Inform II platform.

In hospitalized patients diagnosed with COVID-19, diabetes mellitus is associated with a higher mortality. Patients with controlled blood glucose have a lower mortality rate than those who are uncontrolled. However, a rigid blood glucose control - which may lead to hypoglycemia- is associated with higher mortality rates. Thus, adequate glucose monitoring is important for hospitalized diabetic patients.

Previous studies have shown that CGMS, in the outpatient setting, engender better glycemic control thereby reducing risk of hypoglycemia. CGMS offer a replacement for finger stick blood glucose monitoring which may not identify an incidence of hypoglycemia until symptoms drive the patient to test. Furthermore, finger stick blood glucose monitoring is painful and time consuming thus causing many patients to avoid this aspect of diabetes self-care management.

Freestyle Libre CGMs sample interstitial fluid glucose subcutaneously. Measurement frequencies typically range from 1 to 15 minutes and most commonly are every 5 minutes.

Previous studies in hospitalized patients living with diabetes mellitus on basal bolus regimen have shown:

• Use of the CGM increased detection of both hypoglycemic and hyperglycemic events versus those sensed by POCT.

One investigation identified 88 postprandial hyperglycemic excursions in patients with CGM use as opposed to 61 in those with POCT. Another noted that when comparing the CGM use with that of POCT, the former identified 55 hypoglycemic events whereas the latter only found 12.

• No difference in mean daily glucose CGM and POCT readings. In a study of 38 patients, the investigators noted no difference in mean daily glucose between the CGM and POCT.

Eligibility Criteria:
Inclusion Criteria:

* Participants acquired from among all non-critical care in patients who are living with Diabetes Mellitus. Because the patients will have to be instructed on the use of the CGM, this study will be limited to English speaking/reading adults (18 years of age or older), who possess the cognitive and physical ability to participate.

Exclusion Criteria:

* Minors, pregnant women, and critically ill.
The Effect of Providing Free Samples of Generic Cardiovascular Medications to Physicians

In this randomized controlled trial, we will provide primary care physicians with free samples of highly effective generic cardiovascular medications. We will test whether this intervention will stimulate cost-effective prescribing, reducing drug costs and improving adherence to essential cardiovascular medications.

Highly-effective generic cardiovascular medications are frequently underused, leading to greater overall drug costs and cost-related non-adherence. Interventions are needed to stimulate appropriate generic drug use without creating administrative or financial barriers to branded medications that may impede essential medication use.

The SAMPLES trial is a clustered, randomized controlled trial of the effect of providing physicians with free generic samples of hydrochlorothiazide for hypertensive patients and simvastatin for patients with hyperlipidemia. We will randomize 660 primary care physicians in Pennsylvania, clustered by physician practice, to receive free samples for both conditions or to receive no samples. We will use pharmacy claims of their patient population enrolled in a state-sponsored prescription drug assistance program to evaluate outcomes of interest. The primary outcomes are physician prescribing behavior (proportion of prescriptions that are generic), and patient adherence to chronic therapy. Secondary outcomes will include physician adherence to established guidelines (for anti-hypertensive regimens) and overall prescription drug costs. Primary analyses will be based on intention-to-treat principles.

This trial highlights a new and innovative approach to stimulate cost-effective prescribing. Free generic samples can reduce overall drug costs as well as out-of-pocket costs to the patient without sacrificing efficacy, and may result in improved adherence to essential cardiovascular medications. This intervention may also improve adherence to practice guidelines and improve the quality of care received. If found to be effective, this strategy could be utilized broadly by private insurers or government payers aiming to stimulate more cost-effective and higher-quality care.

Eligibility Criteria:
Inclusion Criteria:

* Primary care physicians receiving an existing academic detailing program in Pennsylvania

Exclusion Criteria:

* Those with administrative policies stating they do not accept free samples
Pretreatment Quality of Life as a Predictor of Distant Metastasis-Free Survival and Overall Survival in Patients With Head and Neck Cancer

This study shed light on an under-researched area by examining the prognostic associations of pre-treatment QoL with overall survival and distant metastasis free survival among patients with head and neck cancer who underwent free flap reconstruction. In addition, a validated instrument specific to head and neck cancer, i.e. the University of Washington Quality of Life Questionnaire (UW-QoL) was adopted.

The importance of patient-related outcomes, especially quality of life (QoL) has been recently emphasized in the field of oncology. In conjunction with traditional biomedical indicators, QoL is recognized as a reliable parameter to reflect the health status of patients with malignancy. A growing body of evidence even points out that QoL can produce prognostic information which goes beyond biomedical indicators. In particular, since QoL may decline before any possible deterioration in health can be detected by existing biomedical measures, assessing pre-treatment QoL possibly helps identify the patients who are susceptible to a higher risk of mortality after they receive cancer treatment, which may greatly facilitate the process of clinical decision making. Despite the importance of pre-treatment QoL, its prognostic associations with overall survival and distant metastasis free survival still remain relatively under-explored.

Eligibility Criteria:
Inclusion Criteria:

* Patients with oral cavity, tongue, gingival, pharyngeal, laryngeal, or salivary gland cancer and cervical lymph node metastasis, and
* Received free flap reconstruction between November 2010 and June 2014 at a medical university hospital

Exclusion Criteria:

* Patients with distant metastasis identified in their medical records, or
* Undergoing reconstruction other than anterolateral thigh, fibular bone and radial forearm flaps
Clinical Trial Based on the Use of Mononuclear Cells From Autologous Bone Marrow in Patients With Pseudoarthrosis

The purpose of this clinical trial is to check the non-inferiority and lower morbidity of the use of bone marrow mononuclear cells seeded onto a porous matrix of calcium phosphate, for the consolidation of tibial bone defects (pseudoarthrosis), compared with autologous bone graft.

An estimated 10% of closed fractures and between 35-45% in cases of open fractures, are at risk of developing a delay in the process of consolidation or a complete failure of it (pseudoarthrosis) depending on location , severity of trauma on bone, soft tissue and vascular structures Some of these cases are refractory to all treatment methods available today, requiring numerous interventions with the potential risk for recurrent infections that they carry. For this reason, its treatment remains a challenge for the orthopedic surgeon.

Recent advances in knowledge of cellular and molecular biology related to the mechanism of bone repair and biomaterials science have been joined in a new discipline called tissue engineering, its implementation in clinical practice is being done so progressive.

Cell therapy based on the use of adult stem cells (MSCs) derived from autologous bone marrow, introduces new applications for the repair of fractures including pseudoarthrosis and avascular bone necrosis.

Its mechanism of action does not focus only on their local action, but also in the release of signaling molecules with autocrine and paracrine action through recruitment and activation of endogenous MSCs to osteoblastic differentiation and bone tissue regeneration.

On the other hand, the seeding of MSCs on biomaterials (natural or synthetic) is more effective, to facilitate adherence, proliferation and extracellular matrix production in the area where implanted.

Today, the investigators can say that there are experimental and clinical evidence supporting the effectiveness of the method.

The investigators have designed a phase II clinical trial to check the feasibility of this approach.

Eligibility Criteria:
Inclusion Criteria:

* Pseudarthrosis of tibia established any cause with at least 9 months.
* The pseudarthrosis is not to show signs of healing in the last 3 months.
* The pseudarthrosis subsidiary should not be solely osteosynthesis treatment.
* Age between 18 and 75 years.
* Serology Human Immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) negative.
* Negative pregnancy test in women of childbearing age.
* Patient sufficient guarantees of adherence to protocol.
* Signature written informed consent before a witness

Exclusion Criteria:

* Systemic infection.
* Septic pseudoarthrosis.
* Insufficient skin coverage at the site of nonunion.
* Vascular insufficiency in the affected limb.
* Pathological fracture.
* Concomitant psychiatric or neurological disease.
* Concurrent or prior malignancy treated with chemotherapy over a period of less than 1 year.
* Concomitant severe disease not well controlled.
* Inclusion in other clinical trials.
* Inability to understand the informed consent
Evaluation of Novel Lung Function Parameters in Patients With Bronchial Asthma

Current guideline-based criteria defining bronchial asthma do not always meet the challenges set by the complex pathophysiology of the disease. The investigators therefore aimed to evaluate novel or not widely used functional diagnostic approaches for the detection and therapeutic monitoring of patients with asthma.


Eligibility Criteria:
Inclusion Criteria:

* known or suspected bronchial asthma
* known or suspected obstructive ventilation disorder
* pulmonary healthy controls

Exclusion Criteria:

* pregnancy
* inability to participate
Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Osteoarthritis (OA) Pain

The purpose of this study is to evaluate the effectiveness of the Matrix Fentanyl Patch ZR-02-01 in providing pain relief.

This study will evaluate the analgesic efficacy of the matrix fentanyl patch. The study will be conducted in non-opioid tolerant patients with moderate to severe osteoarthritis (OA) pain. This patient population was chosen in anticipation that the patients are otherwise healthy adults being treated with NSAIDs (Nonsteroidal Anti-inflammatory Drugs) or acetaminophen or who have received intermittent opioid analgesic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 40 and 75 years of age suffering from moderate to severe chronic pain caused by osteoarthritis.

Exclusion Criteria:

* Patient is already taking chronic opioids or has a history of substance abuse or has a substance abuse disorder.
Fatigue Caused by Chemotherapy in Women Who Have Undergone Surgery for Breast Cancer and in Healthy Volunteers

RATIONALE: Gathering information over time from women undergoing chemotherapy for breast cancer may help doctors learn more about mental and physical fatigue caused by treatment.

PURPOSE: This clinical trial is studying fatigue caused by chemotherapy in women who have undergone surgery for stage I, stage II, or stage III breast cancer and in healthy volunteers.

OBJECTIVES:

* To assess treatment-related fatigue, cognitive dysfunction, and recovery in women undergoing adjuvant chemotherapy for stage I-III breast cancer as compared with a patient-selected control population.
* To determine whether fatigue induced by sustained isometric contraction (SIC) is more of central or peripheral (muscular) origin in patients with and without treatment-related fatigue.
* To characterize changes from baseline in potential abnormal signal processing in the brain while performing cognitive-assessment testing (CAT) in patients experiencing chemotherapy-related cognitive dysfunction compared with the controls.

OUTLINE: Patients and participants undergo assessment of treatment-related fatigue and cognitive dysfunction (i.e., mental fatigue) at baseline, after completion of 3-4 courses of standard adjuvant chemotherapy, and 1-3 weeks after completion of the most recent treatment. Patient recovery will be assessed at approximately 1 year from baseline. Study assessments will include a brief fatigue inventory, a cognitive assessment, and muscle fatigability testing through a sustained isometric contraction. Additional assessments will include quantification of brain and muscle signal alterations in patients with and without treatment-related fatigue and cognitive-assessment testing in patients experiencing chemotherapy-related cognitive dysfunction.

Patients and participants also undergo collection of data to obtain information on patient age, body mass index, and menopausal status at baseline and at 1 year. Additional information is collected on type of chemotherapy treatment and any hormonal or other anticancer treatments administered throughout the course of the study. Cancer recurrences or new cancer events are also recorded.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets either of the following criteria:

  * Has completed surgery for stage I-III breast cancer AND meets the following criteria:

    * No bilateral axillary dissection
    * Clinically free of active disease
    * Planning to receive adjuvant chemotherapy for operable breast cancer
  * Friend or relative of patient matched for age (± 10 years) (control)
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Known menopausal status
* Able to read English
* No history of significant cardiovascular disease or stroke, polyneuropathy, amyotrophy, myosthenic syndrome, or pulmonary compromise
* Prior depression allowed provided that it was not significant
* Willing to come to the Cleveland Clinic for 3 assessments

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics