cyrilzakka/clinical-trials huggingface dataset:
Radiation Therapy to the Brain or Observation in Preventing Brain Metastases in Patients With Advanced Non-Small Cell Lung Cancer

RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. It is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer.

OBJECTIVES:

Primary

* Determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride.

Secondary

* Determine the progression-free survival in patients treated with this regimen.
* Determine the overall survival in patients treated with this regimen.
* Determine the safety and tolerability of this regimen in these patients.
* Determine the psycho-neurological effects of this regimen in these patients.
* Determine the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy regimens (first line vs second line), and disease response status (complete response or partial response vs stable disease). Patients are randomized to 1 of 2 treatment groups.

* Group 1: Patients undergo prophylactic brain radiotherapy.
* Group 2: Patients undergo observation. Patients complete quality of life (HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20) questionnaires periodically.

After completion of study therapy, patients are followed up periodically.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed non-small cell lung cancer

  * Stage IIIB or IV disease
  * Must have had ≥ 8 weeks of gefitinib or erlotinib hydrochloride therapy
* At least 12 weeks of complete response or partial response since starting gefitinib or erlotinib hydrochloride

  * Stable disease allowed provided 1 of the following criteria is met:

    * EGFR mutation (exon 19 or 21)
    * Having ≥ 2 of the following 3 factors:

      * Female
      * Never smoked
      * Histologically confirmed adenocarcinoma of the lung
* No evidence of brain metastases by CT scan or MRI within the past 4 weeks

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 150,000/mm\^3
* Bilirubin \< 1.5 mg/dL
* Serum creatinine \< 1.5 times upper limit of normal

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Received 1 or 2 prior systemic chemotherapy regimens
Effect of Weight Loss on Myocardial Metabolism and Cardiac Relaxation in Obese Adults

Obesity adversely affects myocardial (muscular heart tissue) metabolism, efficiency, and diastolic function. The objective of this study was to determine if weight loss could improve obesity-related myocardial metabolism and efficiency and if these improvements were directly related to improved diastolic function.

This was a prospective, interventional study in obese adults ages 21 to 50 years of age to determine whether weight loss could improve obesity-related myocardial metabolism and efficiency. Two different mechanisms of weight loss were studied: diet and exercise and gastric bypass surgery. Positron emission tomography (PET) was used to quantitate myocardial oxygen consumption (MVO2) and myocardial fatty acid (FA) metabolism. Echocardiography with tissue Doppler imaging was used to quantify cardiac structure, systolic and diastolic function (left ventricular (LV) relaxation (E') and septal ratio (E/E')).

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) \> 30 kg/m\^2
* Sedentary lifestyle

Exclusion Criteria:

* Body weight \>159 kg
* Insulin-requiring diabetes
* Heart failure
* History of coronary artery disease
* Chest pain
* Untreated sleep apnea
* Being an active smoker
* Pregnant, lactating, or postmenopausal
Impact of Extensive Consultation on Career Development Grant Outcomes

In this study we wish is to determine whether extensive (up to 15 hours) multidisciplinary consultation in biostatistics, study design, data management, ethics, and writing provided by the UCSF Clinical and Translational Science Institute's (CTSI) Consultation Services program, improves peer review scores of career development grants compared to usual levels of consultation.

We hypothesize that extensive multidisciplinary consultation will improve peer review scores of career development grants compared to usual levels of consultation.

We hypothesize that extensive multidisciplinary consultation will lead to greater numbers of funded grants when compared to the usual levels of consultation.

CTSI Consultation Services is one of the largest programs within the UCSF CTSI. It was created to improve the quality and efficiency of clinical and translational research through the provision of expert consultation. The program is divided into units that provide access to expert consultants in biostatistics, research design (with consultants representing multiple distinct methodologies and disease interests), data management (including data structure and database design), ethics, and scientific writing. With funding from the NIH, the program is able to offer a free hour of consultation in each of its units (up to 4 hours) but charges for additional services to cover costs.

There have been no studies of research consultation services. Though the benefit may seem self evident, such programs are expensive and distract senior researcher from more creative work. Justifying research consultation is important given the multitude of activities vying for attention and funding. Observational studies of the impact of research consultation services will always be limited by confounding, particularly confounding by indication since those seeking such services may be more highly motivated and organized. Thus, a randomized trial is warranted.

Eligibility Criteria:
Inclusion Criteria:

* Applying for a Career Development grant from the NIH.
* Anticipated submission date is 3 or more months in the future
* Resident, fellow, or junior faculty member at UCSF or a CTSI-affiliated institution.
* Recognized potential benefit from additional consultation

  * Additional areas that could be improved as judged by the subject and the initial consultant
  * Adequate time to provide consultation before submission date
Severe Influenza Cohort

Influenza is a major cause of morbidity and mortality. The investigators first goal is to evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death from Influenza respiratory illness in adult and pediatric patients hospitalized in reanimation. Secondly, the investigators collected respiratory samples in order to study the transcriptomic profiles of influenza-infected patients with severe symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Patient (Adult or Pediatric)
* Hospitalized in reanimation
* With a laboratory confirmed Influenza
* That agree to take part in the study
* Affiliated to National Health Insurance

For ancillary group :

* Adult at least 60 years old
* Presenting at hospital for a blood test

Exclusion Criteria:

* non willing to participate
* Influenza infection with no respiratory symptoms
* pregnancy

For ancillary group :

* Presence of immunodepression defined by:

  * Cancer, or cancer cured for less than 2 years
  * Corticosteroids, Methotrexate (MTX), anti Tumor Necrosis Factor (TNF), anti-CD20
* Infection in progress (fever)
Small-Volume Tubes to Reduce Anemia and Transfusion

STRATUS will evaluate the use of small-volume ("soft-draw") blood collection tubes for laboratory testing in reducing anemia and transfusion in intensive care unit patients without significant adverse consequences. This is a simple, cost-neutral intervention that could improve the quality of patient care and reduce the harms of frequent laboratory testing.

Blood sampling can cause significant unnecessary blood loss particularly in the intensive care unit (ICU). Blood loss contributes to anemia which is highly prevalent in the ICU and is associated with major adverse cardiovascular outcomes and death. Red blood cell (RBC) transfusions to correct anemia also have significant health risks.

Using a stepped wedge cluster randomized trial design, the specific aim of the STRATUS study is to evaluate whether the routine use of small-volume blood collection tubes reduces RBC transfusion compared to standard-volume blood collection tubes in adult ICU patients.

Eligibility Criteria:
ICUs will be eligible if they meet the following criteria:

1. Adult ICU
2. At least 14 level 2-3 ICU beds with capacity for invasive mechanical ventilation
3. Use of vacuum tubes for routine blood collection
4. Able to achieve at least 25% estimated reduction in blood volume by switching to small-volume vacuum tubes
5. Electronic administrative and health record data available for data collection
Safety and Maximum Tolerated Dose (MTD) Study of INNO-206 in Subjects With Advanced Solid Tumors

This is a phase 1b open-label study evaluating the preliminary safety and maximum tolerated dose of a new formulation of INNO-206 administered at doses of 230 mg/m2, 350 mg/m2 and 450 mg/m2 (165, 260, 325 mg/m2 doxorubicin equivalents, respectively) through intravenous infusion on Day 1 every 21 days for up to 6 cycles.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years, male or female.
* Histologically or cytologically confirmed malignant solid tumor that has relapsed or is refractory to standard therapy.
* Subjects who have received prior radiation therapy with stable CNS metastasis with no progression of brain metastasis by CT/MRI scan in last 4 weeks.
* Capable of providing informed consent and complying with trial procedures.
* ECOG performance status 0-2.
* Life expectancy \>12 weeks.
* Measurable or evaluable disease according to RECIST 1.1 criteria.
* Women must not be able to become pregnant (e.g. post menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study.
* Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
* Geographic accessibility to the site.

Exclusion Criteria:

* Palliative surgery, chemotherapy, immunotherapy and/or radiation less than 4 weeks prior to the Screening Visit.
* Exposure to any investigational agent within 30 days of the Screening Visit.
* Laboratory values: Screening serum creatinine greater than or equal to 1.5 mg/dL, alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, total bilirubin greater than 3 times the upper limit of normal, white blood cell (WBC) count \< 3500/mm3, absolute neutrophil count \< 2000/mm3, platelet concentration \< 100,000/mm3, hematocrit level \< 33% for females or \< 35% for males, or coagulation tests (PT,PTT) \>1.5 times the upper limit or normal.
* Clinically evident congestive heart failure \> class II of the New York Heart Association (NYHA) guidelines.
* Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
* History or signs of active coronary artery disease with or without angina pectoris.
* Serious myocardial dysfunction defined scintigraphically (MUGA, myocardial scintigram)or ultrasound determined absolute left ventricular ejection fraction (LVEF) \< 45% of predicted.
* History of HIV infection.
* Active, clinically significant serious infection requiring treatment with antibiotics, antivirals or antifungals.
* Major surgery within 3 weeks prior to treatment.
* Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
* Any condition that is unstable and could jeopardize the subject's participation in the study.
The Effect of Exercise on Motion Perception and Fear in Low Back Pain

Nonspesific low back pain (NLBP), which negatively affects functionality, activity participation, and financial situation, is now one of the leading causes of disability in the world. In NLBP, pain causes kinesiophobia known as fear of movement and limitation of activity. Contrary to what is known, this cycle aggravates pain. With this result, it is suggested that the exercise to be done will improve the perception of benefit in the person and eliminate the fear of movement, and that it will cure the disease. In this context, the aim of the study is to examine the effect of exercise on the perception of exercise and fear of movement in patients with NLBP.

The study will be composed of volunteers, non-specific low back pain individuals who meet the inclusion criteria. First of all, the demographic and clinical characteristics of the patients will be questioned with the evaluation form. The personal information of the patients (gender, height, weight, smoking, etc.) and clinical status (pain type, pain intensity, trunk flexibility measurements) will be recorded by the physiotherapist in the evaluation form. In addition to these measurements, the state of fear of physical movement and activity will be evaluated with the Tampa Kinesiophobia Scale.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily accepting the study
* Having nonspecific low back pain for 3 months or longer
* Not having had spinal surgery in the last 6 months
* Not having an orthopedic or neurological disability that would prevent them from doing their exercises
* Patients who regularly continue their exercises without interrupting

Exclusion Criteria:

* Patients with non-specific low back pain who do not meet the inclusion criteria and want to drop out of the study
SARCOLOWDOSE : Ultra-low Dose CT Scan and MRI in Thoracic Sarcoidosis

The goal of this study is to evaluate the diagnostic agreement between, on the one hand, ultra-low dose CT and MRI with UTE pulse sequences, and on the other hand, standard CT scan, to quantify lung parenchyma patterns in thoracic sarcoidosis.

Sarcoidosis is a chronic disease involving lung and mediastinum in more than 90% of cases. Five to 25% of thoracic sarcoidosis are complicated by a severe fibrotic lung disease. Computed tomography (CT) is critical for the diagnosis of thoracic sarcoidosis as well as for therapeutic management. Repeated CT examinations, sometimes all life long, raise the issue of the cumulative radiation dose and subsequent risk of cancer, thus pushing the need for imaging techniques using low or no radiation dose. Based upon tube voltage and current reduction as well as iterative recontsruction, ultra-low dose CT (ULD CT) allows to lower the dose up to that of a traditional chest X-ray. Magnetic resonance imaging (MRI) using Ultrashort echo time (UTE) enables lung parenchyma imaging with high signal-to-noise and spatial resolution.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or more
* Diagnosed with thoracic sarcoidosis according to ATS/ERS/WASOG 1999 criteria, with stages 2, 3 or 4, or lung function significantly impaired
* For whom a chest CT examination without contrast medium is indicated in the normal follow-up of the disease
* covered by social security
* having received information about the study and having given written informed consent

Exclusion Criteria:

* Pregnant woman
* Adult person unable to give consent
* Patient in exclusion period du to another protocol
Group-based Mindfulness for Chronic Pain in the Primary Care Setting

The purpose of this pragmatic clinical trial (PCT) research is to determine whether a group-visit approach modeled on Mindfulness-Based Stress Reduction can improve function for persons with chronic low back pain. This will be done by an embedded PCT within the evidence-based "OPTIMUM" (Optimizing Pain Treatment In Medical settings Using Mindfulness) program.

The research will be conducted with three health care system (HCS) sites: Boston Medical Center, MA, a safety net health system; UPMC, Pittsburgh, PA, a large health system; and Piedmont Health Services, NC, a network of federally funded health centers in partnership with the University of North Carolina (UNC), Chapel Hill.

As per NIH protocol for the funding, the first 12 month (Phase 1) of this PCT will be a pilot to plan and test the group-based mindfulness program for chronic pain program in each of the three sites with 5 participants/site. Once completed the Phase 2 will be conducted to integrate and test the group-based mindfulness program compared to standard of care for patients with chronic low back pain (cLBP) in the primary care setting at each collaborating site.

Eligible consenting participants will be randomized to either: the primary care providers (PCP) usual care group, or the group with both PCP usual care and the 8 weeks mindfulness clinical pain group. Participants will be asked to complete baseline and follow-up surveys about pain, function, pain medicine use, mood and anxiety symptoms, and quality of life. The surveys will take up to an hour to complete.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Chronic low back pain, which is pain that persists for at least 3-months and has resulted in pain on at least half the days in the past 6 months
* A score ≥ 3 on the PEG
* Willing and able to provide online or telephone informed consent
* Speak English as the intervention manual is currently written in English

Exclusion Criteria:

* Do not meet the above inclusion criteria
* Red flags- recent (past month) worsening of pain, unexplained fever, unexplained weight loss
* Pregnancy
* Metastatic cancer
* First-degree relatives (parents, siblings, child) of someone who has participated or is participating in the OPTIMUM study
* Members of the same household
* Not a patient at a participating clinic or persons not planning to continue as a patient at a participating clinic for 12 or more months
Prehospital Intubation of COVID-19 Patient With Personal Protective Equipment

The safety and efficacy of a laryngoscopy as a primary intubation tool in urgent endotracheal intubation of cardiac arrest patients with suspected/confirmed COVID-19 has not been well-described in the literature. This study will answer whether using a Vie Scope laryngoscope will impact on the efficacy and safety of intubation compared with a traditional direct laryngoscopy.

Intubation will be carried out in full personal protective equipment conditions of the operator

Eligibility Criteria:
Inclusion Criteria:

* All adult patients requiring out-of-hospital intubation

Exclusion Criteria:

* Patient under 18 years old
* Patients with criteria predictive of impossible intubation under direct laryngoscopy
Drug Use Investigation Of Effexor (SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL PRACTICE)

SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL PRACTICE

This study will be conducted under the central registration system until the number of subjects who meet the conditions for registration reaches the target number of subjects. 12 weeks from the start date. The patients who completed the 12-week treatment with this product will be observed up until Week 52.

Eligibility Criteria:
Inclusion Criteria:

* Patients with no experience of using this product who will be administered this product for the first time

Exclusion Criteria:

* Exclusion criteria are not provided in this study
Exploration of Blood Biomarkers, Including Whole Blood Viscosity as a Prognostic Factor for Acute Pancreatitis

This study aims to evaluate the usefulness of blood viscosity as a prognostic factor in patients with acute pancreatitis. The study design is a single-arm prospective cohort observational study. Blood biomarkers including blood viscosity, C-reactive protein, hematocrit, and phosphate are measured and the correlation with the severity of acute pancreatitis will be analyzed.

Several scoring systems are used to evaluate the prognosis of acute pancreatitis, but they are rather complicated and clinically less useful. Blood viscosity is associated with hematocrit and inflammatory factors known to be related to the prognosis of acute pancreatitis, and our group's previous study which is not yet published showed that blood viscosity better predicts severe acute pancreatitis than other single factors such as C-reative protein. Therefore, this study aims to prospectively evaluate the usefulness of blood viscosity as a prognostic factor for acute pancreatitis. During the study period, the study is conducted on patients with acute pancreatitis between the ages of 19 and 70, and patients with acute pancreatitis after ERCP are excluded. Blood viscosities at initial and 24 hours after hospitalization, and serum phosphate, which have shown potential as a predictor of severity in post-ERCP pancreatitis in previous studies are measured. The association of these blood biomarkers with the severity of acute pancreatitis will be analyzed and compared with hematocrit, C-reactive protein, etc., which are known as a single prognostic predictor of acute pancreatitis.

Eligibility Criteria:
Inclusion Criteria:

* Age 19-70 years old
* Acute pancreatitis

Exclusion Criteria:

* Post-Endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis
Evaluation of Direct Transfer to Angiography Suite vs. Computed Tomography Suite in Endovascular Treatment: Randomized Clinical Trial (ANGIOCAT)

To evaluate the hypothesis that an ultra-fast triage with one-stop in angiography suite based on cone-beam CT compared to traditional protocol offers a better outcome in the distribution of the modified Rankin Scale scores at 90 days in acute ischemic stroke patients with suspected large vessel occlusion (LVO) within 6 hours from symptoms onset.

Prospective, randomized, open, treatment-blinded trial of acute stroke patients with suspected large vessel occlusion within 6 hours from symptoms onset in which two strategies will be compared: Direct Transfer to Angiography Suite (DTAS) vs. Computed Tomography Suite (DTCT). The study will be unicentric however there is the possibility of incorporating new stroke centers with previous experience of at least 50 DTAS cases.

The RACE scale (Rapid Arterial oCclusion Evaluation) will be used as a prehospital screening tool to identify acute stroke patients with suspicion of LVO. Once prenotifying the imminent arrival and the verified inclusion and exclusion criteria by the Neurologist at arrival, the patient will be randomized by an app in one of both study protocols.

Subjects will be followed up to 90 days post-randomization.

Eligibility Criteria:
Inclusion Criteria:

* Large vessel occlusion suspected acute stroke codes (RACE\>4) within 6 hours from stroke onset which are prenotified from emergency medical system.
* Confirmed NIHSS\>10 at arrival.
* Good pre-stroke functional status (mRS≤2)
* Angiography suite available.
* Endovascular treatment team available (Neurologist, Interventionist, anesthesiologist, Nursery, Technicians...)

Exclusion Criteria:

* Hemodynamically unstable patients who requires of advanced vital support.
* Patients with an advanced disease that conditions a life expectancy lower than 6 months.
* Participation in other clinical trial with a drug or device which could influence in the outcome.
* Patients with neurological or psychiatric disease that could confound future evaluations.
* Lack of disponibility for 90 days tracing.