cyrilzakka/clinical-trials huggingface dataset:
A Study of Herceptin (Trastuzumab) in Combination With a Taxane in Participants With HER2-Positive Breast Cancer Who Relapsed After (Neo)Adjuvant Herceptin Treatment

This single arm, open-label study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with a taxane as first line therapy in participants with HER2-positive breast cancer who relapsed after neoadjuvant or adjuvant Herceptin treatment. Participants will receive Herceptin (loading dose of 4 mg/kg intravenously \[iv\], 2 mg/kg iv weekly thereafter) with 6 3-week cycles of either docetaxel (100 mg/m2 iv every 3 weeks) or paclitaxel (90 mg/m2 every week). Herceptin treatment will be continued until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Female participants , \>/= 18 years of age
* Locally recurrent/metastatic breast cancer (relapse in supra- or infraclavicular lymph nodes is regarded as metastatic disease)
* HER2-positive primary disease
* Participants must have received Herceptin in the adjuvant and/or neoadjuvant setting
* Relapsed breast cancer \>/= 6 months after discontinuing last drugs of Herceptin and/or chemotherapy in the adjuvant and/or neoadjuvant setting for HER2-positive breast cancer
* Measurable disease according to RECIST 1.0
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Maximum cumulative dose of doxorubicin \</= 360 mg/m2 or of epirubicin \</= 720 mg/m2 or no prior anthracyclines
* At least 3 weeks after prior surgery or radiotherapy

Exclusion Criteria:

* Pregnant or breastfeeding women
* Previous chemotherapy for metastatic breast cancer (prior endocrine therapy till progressive disease is allowed)
* Pleural effusions, ascites or bone lesions as only manifestation of disease
* Brain metastases
* Invasive malignancy other than metastatic breast cancer
* Inadequate bone marrow, hepatic or renal function
* Prior treatment with anti-HER therapies other than (neo)adjuvant Herceptin
All in Dads! Healthy Marriage and Responsible Fatherhood Program Evaluation

The purpose of this study is to help fathers establish and strengthen their relationship with their children and the mothers of their children; to reduce domestic violence in vulnerable families; to improve economic stability of fathers through comprehensive, job-driven career services; to employ intensive case management barrier removal, individual job coaching, and comprehensive family development to improve short and long-term outcomes.

After being informed about the study and giving consent, participants will enroll in a five-week All in Dads! program that collects data at enrollment, at the end of the program, and 12 months following the program. Research questions in this study are framed by a Descriptive Evaluation Design to assess whether outcomes improve for low-income fathers who participate in the All in Dads! (AID!) Project. Primary and secondary outcomes are assessed before and after participants complete core curricula-Father Factor, The New Playbook, and Money Smart-and Job Readiness Coaching and Career Development as employment support services (pre to post). Primary outcome measures will indicate whether behavior improved for healthy family relationships (parent, co-parent, and partner) and economic stability (financial, employment). Secondary outcome measures will indicate whether behavior improved for the attitudes and expectations that facilitate and reflect behavior for healthy family relationships and economic stability.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18 and older)
* Father/father figure
* Reside in Franklin County, Ohio

Exclusion Criteria:

* Minor (under the age of 18)
* Not a father/father figure
* Reside outside of Franklin County, Ohio
Molecular Classification in Mexican Patients With Endometrial Cancer and Its Impact on Prognosis

Endometrial cancer (EC) is one of the most common gynecological neoplasms, being the second in incidence and third in mortality in Mexico. Recent studies show that EC molecular classification (Cancer Genome Atlas Research Network, 2013) serves to establish a more accurate prognosis in these patients and regulate therapeutic behavior in a personalized manner. However, there are no studies on EC molecular classification in Mexican women or its impact on prognosis and the possible modification of targeted treatment. The investigators will determine the molecular classification in EC by next-generation sequencing (NGS) to detect TP53 and POLE somatic mutations, and immunohistochemical detection of microsatellite instability (MSH2, MLH1, PMS1, PMS2, MSH6, and MSH3) in a cohort of patients with endometrioid-type EC, endometrioid subtype, attended at the Instituto Nacional de Cancerología - Mexico (INCan) and determine its impact on clinical prognosis.

The investigators will carry out a pilot study on patients with endometrioid type EC treated between 2015-2019. Samples of patients over 18 years of age admitted to the cohort with a diagnosis of endometrioid-type EC are already collected and will be evaluated for exome sequencing (N=32) and the detection of POLE mutations. DNA will be extracted using the "DNA/RNA AllPrep" kit (QIAGEN). Verification of adequate DNA extraction will be performed by quantifying using TapeStation (Agilent). Exome sequencing (N = 32 tumor samples and 32 somatic samples \[leukocytes\] from the same patient) will be carried out using Illumina's Nextera Rapid Capture Exome at Azenta Life Science (NJ, USA) following preset protocols and with a depth of 100X. The alignment and detection of variants will be done with the GATX-Mutect Suite (Broad Institute, USA) and the annotation of variant filtering with ANNOVAR. The identification of hotspots will be made according to Chen study. The immunohistochemistry (IHC) for microsatellite instability and overexpressed mutant TP53 (N = 94) will be done using established IHC protocols and will include MSH2, MLH1, PMS1, PMS2, MSH6, MSH3, and TP53.

Eligibility Criteria:
Criteria: Inclusion Criteria:

* Clinical diagnosis of endometrioid-type endometrial cancer with samples available
* That the patients have undergone surgery at INCan.

Exclusion Criteria:

* Samples with CEE of non-endometroid type.
* Samples from patients with double primary neoplasm, including carcinoma ductal in situ, squamous cell skin cancers, and cervical carcinoma in situ
* History of malignancy \< 5 years prior with no evidence of disease (i.e., remission).
Analysis of Vital, Facial and Muscular Responses Front to Music or Message in Coma, Vegetative State or Sedated Patients

Objectives: (1) To check music or voice message influence on vital signs, facial expressions or muscular tonus of coma, vegetative or sedated patients; (2) To connect the existence of patient's responsiveness with the Glasgow Coma Scale or with the Ramsay Sedation Scale; (3)To evaluate the relation between the response and the score of Glasgow Outcome Scale.


Eligibility Criteria:
Inclusion Criteria:

* To be in disorder of consciousness;
* To be evaluated according to one of the Scales and to have a score in the study range: in physiological comas, score between 3 to 8 Glasgow Coma Scale (GCS); in induced coma, one of the last two scores of Ramsay Sedation Scale (RSS), R5 or R6;
* To have hearing function preserved according to family;
* To have written consent from the family or responsible party for the patient's participation

Exclusion Criteria:

* Score between 9 to 15 in GCS or scores R1, R2, R3 or R4 in RSS
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Insight® Pro Device for Evaluating Lymphatic and Venous Disorders (VOLGA)

To demonstrate that the Insight Pro Device is safe and effective for use in detecting lymphatic and venous disorders.

6. Clinical Hypotheses

1. The Insight Pro device can detect a difference in extracellular fluid volume through bioimpedance and dielectric constant measurement.
2. The Insight Pro device can detect a difference in skin hardness or fibrositis through a durometer measurement.
3. The Insight Pro device is safe for use as assessed by adverse events.

Eligibility Criteria:
Inclusion Criteria:

Test group -

* Males and females ≥ 18 years of age
* Willing to sign the informed consent and deemed capable of following the study protocol
* Subjects must have primary or secondary unilateral or bilateral upper or lower extremity edema
* At the time of initial evaluation, individuals must be at least 3 months post-surgery, chemotherapy and/or radiation treatment for cancer if applicable

Control group -

* Males and females ≥ 18 years of age
* Willing to sign the informed consent and deemed capable of following the study protocol
* Subjects must not have primary or secondary edema and self-describe general healthy

Exclusion Criteria:

* ● Inability or unwillingness to participate in all aspects of the study protocol and/or failure to provide informed consent

  * Patients with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
  * Diagnosis of active or recurrent cancer (\< 3 months since completion of chemotherapy, radiation therapy, or primary surgery for the cancer)
  * Patients with cardiac arrhythmia with pacemakers or other implanted electronic equipment
  * Patients must not have implanted metal hardware in the limbs
  * Patients undergoing external defibrillation
  * Diagnosis of Acute infection (in the last four weeks)
  * Diagnosis of acute thrombophlebitis (in last 2 months)
  * Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 2 months
  * Diagnosis of congestive heart failure (uncontrolled)
  * Diagnosis of chronic kidney disease with acute renal failure
  * Women who are pregnant, planning a pregnancy or nursing at study entry
  * Participation in any clinical trial of an investigational substance or device during the past 30 days
Bleomycin in Treating Patients With Non-Hodgkin's Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of bleomycin in treating patients with non-Hodgkin's lymphoma.

OBJECTIVES: I. Determine the objective response rate, response duration and survival of patients receiving bleomycin as salvage therapy for AIDS-related or immunocompetent non-Hodgkin's lymphoma. II. Assess the feasibility and toxicity of treatment for this disease. III. Evaluate the quality of life of AIDS and non-AIDS patients with non-Hodgkin's lymphoma.

OUTLINE: Patients are stratified by number of prior cytotoxic chemotherapy regimens, prior radiotherapy, and HIV/AIDS status. Patients receive bleomycin by continuous infusion for 72 hours every 3 weeks. Induction therapy consists of 3 cycles. Patients who achieve complete remission receive 2 more cycles. Patients with partial remission or stable disease may continue therapy until disease progression or unacceptable toxicity occurs. Quality of life assessments are conducted at beginning of therapy, every 3 weeks, and at completion of treatment. Patients are followed every 3 months for overall survival.

PROJECTED ACCRUAL: A total of 32 patients will be accrued.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed recurrent intermediate or high grade non-Hodgkin's lymphoma (NHL) AIDS-related NHL eligible At least 1 evaluable or measurable disease as defined by the following: Radiographic findings are acceptable Bidimensionally measurable defect on a computed tomographic (CT) scan Clearly defined abdominal masses on CT scans Enlarged spleen and/or liver extending at least 5 cm below the costal margin Biopsy proven lymphomatous hepatic involvement No clinical or radiographic evidence of parenchymal CNS involvement by lymphoma (meningeal lymphoma permitted) A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age: Any age Performance status: ECOG 0-3 Life expectancy: At least 6 weeks Hematopoietic: WBC at least 1500/mm3 Platelet count at least 50,000/mm3 Hepatic: Bilirubin no greater than 3.0 mg/dL Renal: Creatinine no greater than 3.0 mg/dL Other: May be HIV positive Immunocompetent (HIV-seronegative) NHL patients must be suitable candidates for bleomycin chemotherapy Active infections undergoing drug treatment allowed Negative head CT/MRI scan

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 1 prior systemic chemotherapy regimen Endocrine therapy: Not specified Radiotherapy: Prior radiation therapy for localized stage I/II disease that has progressed beyond initial radiation therapy port is allowed Surgery: Not specified Other: Concurrent zidovudine, didanosine, or zalcitabine therapy allowed
Use of the Thrombectomy Device ReVive™ SE in the Acute Treatment of Stroke

The last marketed thrombectomy devices, named stentretriever, permit a better and faster recanalization in patient with a stroke. The REVIVETM SE is a device designed to restore the brain perfusion in patient with an intracranial artery occlusion. The REVIVETM Se device is not widely use in Europe and in France. The objective of this study is to assess the interest of using this device in the standard care of ischemic stroke in the radiology unit of the hospital Pierre Wertheimer, Lyon. The medical care will not be modified but data will be collected in order to determine whether or not this device is useful for the practice of the radiology unit.


Eligibility Criteria:
Inclusion Criteria:

* Patient with an ischemic stroke detected by Computed Tomography (CT) or Magnetic Resonance Image (MRI)
* Large proximal arterial occlusion : M1 segment of the Middle cerebral artery (MCA), Internal Carotid Artery (ICA) or Basilar Artery (BA)
* Last known well (without neurological symptoms) ≤ 8 hours of treatment initiation
* Score NIHSS ≥4
* Eligibility on an endovascular procedure using REVIVETM SE device
* No opposition of the patient to participate at the study

Exclusion Criteria:

* Diagnostic cerebral imaging impossible
* Distal occlusion
* Tortuous vessel or other specificity preventing the access of device
* Vessel diameter \< 1.5 mm
* Known hypersensibility or allergy to nitinol
* Subjects not covered by or having the right to social security
* Deprivation of civil rights (guardianship, safeguard justice)
Outcomes of Antipsychotic Medication Used in the Emergency Department

To review records of patients treated with antipsychotics (including Adasuve, Geodon, Haldol) in order to evaluate outcomes.

A retrospective chart review will be performed for all patients presenting to the ED with agitation and subsequently given antipsychotic therapy for treatment. Identification of patients will be through chart review of patients presenting with agitation. Data to be recorded include patient age, gender, medical history, time of presentation, time of treatment, co morbidities, use of restraint, time to disposition and patient outcome. Inclusion criteria include all patients over age 18 presenting to the ED with agitation and treated with antipsychotics. No patients will be knowingly excluded from analysis. We will compare resulting outcomes of patients treated for agitation to see if Adasuve is superior to other commonly prescribed antipsychotics through its rate of discharge home and overall time in the emergency department.

Eligibility Criteria:
Inclusion Criteria:

* All patients given antipsychotic therapy for acute agitation

Exclusion Criteria:

* None
InSync Implantable Cardioverter Defibrillator Registry: Cardiac Resynchronization Therapy

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three or four leads (soft insulated wires) that are inserted through the veins to the heart.

People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD). An ICD is implanted surgically just under the skin in the upper chest area and it sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm. If the heart is beating too slowly or at an abnormal rhythm, an ICD can also pace the heart to return the heart to its normal rhythm. The InSync ICD device can change the timing of when the left and right ventricles of the heart are paced to beat.

The purpose of this study is to monitor the long-term performance of the InSync ICD Model 7272 and the InSync Marquis 7277 systems for cardiac resynchronization therapy (CRT).


Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with the InSync ICD or InSync Marquis cardiac resynchronization therapy (CRT) system (includes InSync ICD Model 7272 or InSync Marquis Model 7277, right atrial lead, right ventricular lead and any market released Medtronic left ventricular lead or the investigational Attain Model 4189 lead which was implanted during the MIRACLE ICD Study)

Exclusion Criteria:

* Patients with a history of a previously failed placement of a currently investigational Medtronic left ventricular lead within 30 days of enrollment in the InSync ICD Registry
Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer

This phase II clinical trial studies how well omega-3 fatty acid works in treating patients with stage I-III breast cancer. Studying samples of tissue and blood in the laboratory from breast cancer patients receiving omega-3 fatty acid may help doctors learn more about the effects of omega-3 fatty acid on tumor cells.

PRIMARY OBJECTIVES:

I. To determine if omega-3 dietary supplementation (omega-3 fatty acid) results in higher polyunsaturated fatty acids (PUFA) levels in surgical specimens of normal and malignant breast tissue in women who took omega 3 tablets in comparison to those who took placebo.

II. To determine if omega-3 dietary supplementation results in higher PUFA levels in plasma and red blood cells in women who took omega 3 tablets in comparison to those who took placebo.

III. To determine if omega-3 dietary supplementation affects the metabolites of omega-3 and omega-6 PUFA in surgical specimens of malignant and normal breast tissue in comparison to controls.

IV. To determine if women who take omega-3 dietary supplementation have less proliferation and greater apoptosis in malignant breast tissue in comparison to women who take placebo.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive omega-3 fatty acid orally (PO) daily for 7-14 days.

ARM II: Patients receive placebo PO daily for 7-14 days.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed stage I to III breast cancer and carcinoma in situ (including lobular carcinoma in situ \[LCIS\] and ductal carcinoma in situ \[DCIS\])
* Breast surgery (lumpectomy or mastectomy) is planned for at least 7 days from the day of enrollment
* Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved written informed consent document
* Tumor measures at least 1 centimeter on imaging or physical exam

Exclusion Criteria:

* Any patient with surgery scheduled \< 7days after biopsy
* Patients who are unable to refrain from the use of any NSAID or full-dose acetylsalicylic acid (ASA)-containing NSAID while taking study drug
* Patients who will receive neoadjuvant chemotherapy are not eligible
* Patients who are currently taking omega-3 fatty acids, as they are unable to be randomized to placebo
* Patients who have previously taken omega-3 fatty acid within 1 month prior to study enrollment
* Patients with an allergy or known hypersensitivity to fish
Microcirculation Properties of Albumin for Fluid Resuscitation in Septic Shock

The sublingual microcirculation is impaired in sepsis and septic shock. Sidestream dark field imaging technology has been developed into a clinical tool to help the clinician assess the microcirculation at the bedside. The ideal resuscitation fluid has not been identified. The investigators aim to use this new bedside technology to establish the microcirculation properties of two popular resuscitation fluids.

Sepsis and septic shock are diseases of the microcirculation. Recent developments in microcirculation imaging have illustrated the extent of the impairment of the microcirculation in these diseases of critical care. Heterogenous flow, stagnation and microthrombi can all be seen clearly in the sublingual region using a sidestream dark field imaging device.

One of the key treatments for sepsis and septic shock is timely administration of intravenous fluids. Which fluid is administered is a matter for debate which has not been settled by several large trials. De-resuscitation has become increasingly important as physicians realise the implications and associated risks of excess fluid administration in ICU. Avoiding excess fluid administration at the resuscitation stage is therefore desirable. One of the prevailing theories about the function of albumin or colloid resuscitation is that it remains in the the intravascular space for a longer period of time, thereby continuing to benefit the patient and avoiding administration of excess fluid. However, recently albumin was tested against crystalloid for resuscitation and was shown to be effective but with no improvement in survival.

It is possible, however, that albumin is having an initial beneficial effect at a microcirculation level. Macrohaemodynamic improvements are not necessarily matched by improvements in blood flow and oxygen delivery to cells, this has been referred to as haemodynamic incoherence.

This randomised, prospective study aims to compare crystalloid and albumin resuscitation at a microcirculation level.

Eligibility Criteria:
Inclusion Criteria:

* Sepsis; suspected source of infection, tachycardia, tachypneic, hyperlactatemia, hypotensive requiring vasopressors, febrile \>38.5degrees Celsius
* Fluid responsive; pulse pressure variability \>10% or passive leg raise positive

Exclusion Criteria:

* Fluid overloaded; pulmonary oedema, significant peripheral oedema
* Heart Failure, cardiogenic shock, recent MI
* Receiving regular albumin 20%