cyrilzakka/clinical-trials huggingface dataset:
Effect of Salmeterol on Fluid Clearance From Alveolar-Capillary Membrane in COPD Patients

The cardiovascular component associated with COPD plays a major role in prognosis of the disease, being responsible of 25% of the deaths. Experimental and initial clinical data suggest that beta-adrenergic agonists accelerate clearance of excess fluid from the alveolar airspace, with potential positive effect on cardiogenic pulmonary edema.

The aim of this study was to investigate the effects of a long-acting beta-2 agonist, salmeterol, on alveolar fluid clearance in COPD patients by evaluating the diffusive and mechanical lung properties. Our experimental model to test alveolar fluid clearance was rapid saline intravenous infusion.

Ten COPD and 10 healthy subjects treated with salmeterol or placebo 4 hours before the begin of the study were evaluated, in four non consecutive days, just before and after a saline infusion or a similar period without infusion.

Both in COPD and healthy subjects rapid saline infusion, with placebo or salmeterol premedication, lead to a significant decrease of DLCO and FEV1. Nonetheless, salmeterol pretreatment lead to a significant reduction of the impairment of gas exchange due to saline infusion (-64% of DLCO reduction in comparison with placebo), whilst it did not affect the changes in FEV1. In the control setting, with no infusion, we did not find any significant change of both DLCO and mechanical properties of the lung.

In conclusions, in COPD patients salmeterol appears to provide a protective effect against an acute alveolar fluid clereance challenge secondary to lung fluid overload providing an intriguing mechanistic explanation for the benefits observed in larger trials.


Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis (consistent with the diagnostic standards of the European Respiratory Society, ERS, for the management of COPD)
* stable condition for ≥4 weeks and had a prebronchodilator forced expiratory volume in one second (FEV1) of \<60% of the predicted value

Exclusion Criteria:

* known allergies to the study medication
* long-term oxygen therapy
* history of asthma, allergic rhinitis, atopy, or a total blood eosinophil count greater than 400/mm3
* chronic heart failure, untreated arterial hypertension, myocardial infarction within the last 6 months, diabetes mellitus
* increased serum potassium levels.
A Study Evaluating the Effect of Pembrolizumab (MK-3475) in Participants With Renal Cell Cancer (MK-3475-031)

This study will examine the effect of treatment with the neoadjuvant antibody pembrolizumab (MK-3475) on tumors of participants with renal cell cancer (RCC). The primary hypotheses are that pembrolizumab is well tolerated in participants undergoing RCC tumor resection; and that pembrolizumab will stimulate a 2-fold or greater increase in intratumoral lymphocytic infiltration in at least 30% of participants with RCC.


Eligibility Criteria:
Inclusion Criteria:

* Have a newly diagnosed RCC, with a primary tumor diameter of more than 4 cm (\>= T1b), not previously treated, and be a candidate for operative tumor resection
* Be willing and able to undergo pre-treatment baseline image-guided core biopsy of their primary RCC
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
* Demonstrate adequate organ function
* Female is not breast feeding, is postmenopausal or surgically sterile; demonstrates non-pregnant state, and agrees to use two acceptable methods of birth control throughout the trial, until 120 days after the last dose of treatment
* Male with female partner of childbearing potential agrees to use adequate method of contraception throughout study, until 120 days after last dose of treatment or last blood draw.

Exclusion Criteria:

* Is currently participating in, or has participated in a study with an investigational agent or device within 4 weeks prior to first dose of study therapy
* Has a diagnosis of immunosuppression or has received systemic steroid therapy, or any other form of immunosuppressive therapy within 4 weeks prior to first dose of study therapy
* Has had prior chemotherapy, targeted small molecule, or radiation therapy for treatment of RCC
* Has a known additional (other than RCC) malignancy that is progressing or requires active treatment
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has an active, or documented history of autoimmune disease, with the exceptions of vitiligo or resolved childhood asthma/atopy
* Has a history of (non-infectious) pneumonitis that required treatment with steroids or current pneumonitis.
* Has an active infection requiring systematic therapy
* Is receiving anticoagulant therapy, with the exception of low dosage aspirin
* Has severe cardiovascular disease or symptomatic ischemic heart disease
* Has hepatic decompensation
* Has uncontrolled thyroid dysfunction
* Has uncontrolled diabetes mellitus
* Has known psychiatric or substance abuse disorders
* Female is pregnant or breastfeeding
* Is expecting to conceive children within the projected maximum duration of the trial, extending through 120 days after the last dose of treatment or the last blood draw
* Has received prior therapy with any antibody or drug (including ipilimumab) specifically targeting T-cell co-stimulation or checkpoint pathway
* Has a known history of human immunodeficiency virus (HIV)
* Has known active hepatitis B or C
* Has received a live vaccine within 30 days prior to screening
Modifying PEST for Psoriatic Arthritis Screening

The purpose of this study is to assess the impact of adding two questions and pictures to the validated PEST on the potential diagnosis of PsA in participants with moderate-to-severe plaque PsO in Canada.

Patients will be enrolled in the study for up to 66 days and will be asked to fill-out a PsA screening questionnaire at their first dermatologist visit. Patients screening positive for PsA will have a second visit with a rheumatologist where a full PsA diagnosis assessment will be performed. A remote 'end of study' (EOS) visit will be conducted by the dermatologist to document the patient's biologic Disease-Modifying Antirheumatic Drugs (bDMARDs) treatment choice and status.

Eligibility Criteria:
Key inclusion criteria:

1. Moderate-to-severe plaque PsO patients who are candidates for bDMARDs, as per provincial reimbursement criteria
2. Adult patients at the time of informed consent signature
3. Patients able to understand and willing to comply with protocol requirements, instructions, and restrictions
4. Residents of Canada

Key exclusion criteria:

1. Patients who have previously screened positive for PsA through PEST or any other screening method
2. Patients who have been diagnosed with PsA and/or followed by a rheumatologist
3. Patients who have been diagnosed with inflammatory arthritis unrelated to PsA (rheumatoid arthritis, reactive arthritis, enteropathic arthritis, axial spondyloarthritis)
4. Patients treated with a bDMARD for moderate-to-severe plaque PsO or any other medical condition
Factors Correlated With Fatigue in Breast Cancer

The aim of this study is to identify the determinants of cancer-related fatigue, and the long-term effect of the different adjuvants treatments will be explored. A prospective longitudinal study in women diagnosed for the first time with stage I-III breast cancer and who have undergone surgery, has been designed to meet the study aims.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years and older
* newly diagnosed with stage I-IIIA breast adenocarcinoma
* have undergone surgery
* WHO performance status score equal or lower than 2
* able to provide informed consent
* speak French and able to complete self-report questionnaires

Exclusion Criteria:

* pregnancy
* bilateral breast cancer
* metastatic breast cancer
* patients who received neoadjuvant chemotherapy
* known psychiatric disease or dementia
* no previous history of cancer
The Effect of Routine Video-recording on Colonoscopy Quality Indicators.

Routine video recording of the colonoscopy examination has been proposed as a simple and easy to implement method that could improve the quality of colonoscopy. The purpose of this study is to investigate whether implementation of routine video recording of screening colonoscopy withdrawal is effective as a means of supporting quality performance of colonoscopy. The study will be performed in 8 screening centers within the framework of a national colonoscopy screening program in Poland (the Polish Colonoscopy Screening Platform; PCSP). Individuals aged 55-64 years are eligible to participate in the PCSP. In the run-in period colonoscopy quality measures will be monitored through a dedicated joint database. Then eligible screening centres will be randomly assigned in a 1:1 ratio to the video recording group or the control group. Screening centres assigned to the video recording group will receive videorecorders and DVDs and will be asked to video record all screening colonoscopies (only withdrawal). Control group will be allowed to record colonoscopies on demand only. Then , the colonoscopy quality measures will again be monitored through a dedicated joint database. All the recorded DVDs will be reviewed to verify ceacal intubation and withdrawal time by the PCSP team.


Eligibility Criteria:
Inclusion Criteria:

* Screening centres participating in the Polish Colonoscopy Screening Platform (PCSP) between 2012 and 2013, in which no routine video recording of screening colonoscopies is performed
* Screening centres which will sign informed consent
Visual Dysfunction in Mild Traumatic Brain Injury (MTBI): A Comparison Group Study

In an on-going study of visual characteristics of personnel diagnosed with a mild traumatic brain injury (MTBI) related to their service in Iraq and Afghanistan we found a high rate of binocular vision problems (such as double/blurry vision, reading difficult, etc.). These individuals are also usually diagnosed with post traumatic stress disorder (PTSD). PTSD is known to cause some vision symptoms. We wish to conduct this study on individuals with PTSD (but not an MTBI) to see if they have symptoms similar to those in individuals who have MTBI. This will provide us with information useful in determining the specific cause of the visual symptoms in the MTBI population.

We will recruit 75 patients diagnosed with PTSD, but with no history of mild traumatic brain injury (MTBI), from the population of the VAPAHCS PTSD Center and Clinics. These volunteers will be scheduled for an eye screening developed for a concurrent project to assess visual dysfunction (accommodation/vergence insufficiency, pursuit/saccade deficits, etc.) in patients diagnosed with MTBI and seen at the Palo Alto Polytrauma Network Site clinic. The MTBI patients have unexpectedly high rates of binocular dysfunction, although their visual acuities and visual fields are normal/near normal. The MTBI diagnosis is associated with a combat blast event in some 90% of cases. Th majority of this population has also been diagnosed with PTSD. PTSD is known to cause some visual symptoms, thus it is necessary for us to determine if the visual dysfunctions in the MTBI are related to their PTSD diagnosis or not. The volunteer participants will be scheduled for an eye screening and consented prior to the screening. Inclusion criteria include diagnosis of PTSD, aged 19 to 39, and willingness to participate. Exclusion criteria is primarily history of TBI. The visual screen includes assessments of visual acuity, visual field, self-reported visual function (i.e., light sensitivity, eye fatigue, reading difficulty), and measures of accommodative function, vergence, pursuit and saccades. The data collected will be compared to the data from the ongoing study of visual dysfunction in patients diagnosed with MTBI.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of PTSD
* no history of MTBI
* between 19 and 39 years of age
* a veteran

Exclusion Criteria:

* a history of MTBI
* over the age of 39
* an unwillingness to participate
CNS Involvement in Primary Mediastinal Large B-Cell Lymphoma (PMLBCL)

This is a retrospective, multicenter study designed to collect data on the diagnostic, therapeutic management and outcome of patients diagnosed with primary mediastinal lymphoma who have progressed or relapsed with central nervous system (CNS) involvement.

Through this study, an international data set from 6 different countries will be collected on clinical factors, anti-lymphoma therapy administered alone or in conjunction with CNS prophylaxis, re-biopsy site information when available, dose intensity of lymphoma therapy received at recurrence, and patient outcome.

In addition, to better characterize the pathologic features of this rare entity, a central pathologic review of the initial diagnosis and, if available, histologic confirmation of recurrence will be performed.


Eligibility Criteria:
Inclusion Criteria:

To be eligible for inclusion each patient must fulfil all of the following criteria:

1. Histologically confirmed diagnosis of Primary Mediastinal Large B Cell Lymphoma (PMLBCL) according WHO Classification
2. Had a recurrence/progression with Central Nervous System (CNS) involvement
3. Availability of details on clinical presentation, treatment details and outcome
4. Availability of details on pathological data for central review
5. Age ≥18 years

Exclusion Criteria:

* Patients with CNS lymphoma other than PMLBCL subtype
COVID-19 - Study of the Kinetics of the Immune Response During the Intensive Care Unit Stay in Adult Patients Infected with SARS-CoV-2: Multicentric Non Interventional Study

Infection with the SARS-CoV-2 coronavirus (COVID-19) has recently been identified as a pandemic due to the speed and global scale of its transmission. In Auvergne-Rhône-Alpes region (AURA), the epidemic began in February 2020 and the number of infected people is still important. Between 15 and 20% of COVID-19 patients develop an acute respiratory distress syndrome (ARDS) leading to their hospitalization in intensive care. Their clinical progression can be rapidly harmful with the development of severe ARDS associated with an increased risk of death.

Preliminary data on the immune response of COVID-19 patients describe the induction of a moderate inflammatory response and the occurrence of major progressive lymphopenia over time associated with potential immunosuppression. Up to 50% of secondary infections are reported in deceased COVID-19 patients. However, no prospective study has exhaustively described the kinetics of the immune response of COVID-19 patients in intensive care.

The precise description of the immune response over time in adult patients with a proven infection with the SARS-CoV-2 virus and the study of the relation between this response and the increased risk of organ failure (severe ARDS), death or nosocomial infection will allow us to better understand the pathophysiology of the immune response induced by COVID-19 in order to (i) identify new therapeutic strategies targeting the host response in patients in intensive care (ii) to develop biological markers to stratify patients for future clinical trials evaluating these immunoadjuvant treatments in COVID-19.


Eligibility Criteria:
Inclusion Criteria:

1. Man or woman aged 18 or over,
2. Hospitalization in intensive care for Sars-Cov-2 pneumopathy,
3. First hospitalization in intensive care unit,
4. Positive diagnosis of SARS-CoV2 infection carried out by PCR or by another approved method in at least one respiratory sample,
5. Sampling in the first 24 hours after admission to intensive care unit (D0 / D1) feasible,
6. Patient or next of kin who has been informed of the terms of the study and has not objected to participating.

Exclusion Criteria:

1. Pregnant or lactating woman,
2. Person placed under legal protection,
Mindful Walking in Low Back Pain

The purpose of this study is to determine whether a mindful walking program is effective in the treatment of patients with chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* male and female, 18-65 years
* chronic low back pain (disease duration \> 3 months)
* pain intensity on visual analogue scale at inclusion \> 40 mm (0-100 mm scale)
* only pharmacological treatment with NSAID or no treatment in the last 4 weeks
* undersigned informed consent form

Exclusion Criteria:

* active walking or jogging in the last 6 weeks (\< 60 minutes/week)
* regular meditation, relaxation exercise, mindfulness exercise in last 6 weeks (\> 30 minutes per week)
* use of complementary medicine therapies as acupuncture, homeopathy, herbal medicine in last 6 weeks or planned in the next 12 weeks
* use of other nonpharmacological therapies as physical therapy, manual therapy or osteopathy in the last 4 weeks
* participation in another trials within the last 3 months
* pathological neurological symptoms such as muscular paralysis or paraesthesia due to spinal disc herniation or other causes
* risk of falls and inability to walk
* angina pectoris in the last 3 months
* chronic respiratory disease with respiratory insufficiency
* intake of central nervous system-acting analgesics in the last 6 weeks
* Known renal and / or hepatic diseases
* Severe organic, psychological or psychiatric disorders that are not permitting a study participation
* applying for early retirement due to low back pain
* no undersigned informed consent form
Impact of Perioperative Exenatide Infusion on Quality of Life in Cardiac Surgery Patients

A diminution of quality of life is often reported by patients after coronary artery bypass graft (CABG) surgery. A part of this diminution could be explain by postoperative left ventricular (LV) dysfunction.

Exenatide (Byetta®) is an incretin mimetic, characterized by an anti-hyperglycemic effect that depends on the blood glucose level. Recent data have suggested that exenatide could improve LV function by an inotropic effect in patients suffering from cardiogenic shock or from congestive heart failure. Moreover, patients suffering from congestive heart failure reported a better quality of life when they were treated with exenatide compared to placebo.

The investigators hypothesize that perioperative exenatide infusion could improve postoperative quality of life in CABG surgery patients.

The ExeQOL study is an ancillary study of the ExSTRESS trial (www.clinicaltrials.gov identifier: NCT01969149).

The ExSTRESS trial is a phase II/III randomized-controlled trial that aim at assessing intravenous exenatide versus insulin for perioperative glycemic control in CABG surgery.

The phase II of the ExStress trial will assess the safety and the efficacy of a continuous intravenous infusion of exenatide for the management of post operative stress hyperglycemia after planned coronary artery graft bypass (CABG) surgery.

The aim of the phase III of the ExSTRESS trial is to compare the efficacy of a continuous intravenous infusion of exenatide to the gold standard treatment, i.e the intravenous infusion of short-acting insulin, for the management of post operative stress hyperglycemia after planned CABG surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18.
* Patient consent.
* Non insulin requiring type 2 diabetic patients.
* Non diabetic patients.
* Planned coronary artery bypass graft (CABG) surgery.
* ASA (American Society of Anesthesiologists) score 1, 2, or 3.

Exclusion Criteria:

* Pregnancy and breast feeding.
* Pancreatectomy.
* Acute pancreatitis.
* Chronic pancreatitis.
* Type 1 diabetic patients.
* Insulin requiring type 2 patients.
* HbA1c\>8%
* Ketoacidosis.
* Hyperosmolar coma.
* Preoperative blood glucose level above 300 mg/dl \[21\].
* Insulin or exenatide contraindication.
* History of renal transplantation or currently receiving renal dialysis or creatinine clearance below 60 ml/min.
* Emergency surgery.
* Planned non CABG cardiac surgery.
RBC Lifespan Measurement in Diabetic Children

HbA1c, a measure of mean blood glucose over the lifespan of a red blood cell (RBC), is a marker of increasing importance both for assessing glycemic control in children with known diabetes and for the diagnosis of diabetes in children. HbA1c has demonstrated poor reliability in diagnosis and management of pediatric diabetes and the most plausible reason for this unreliability is that the reference ranges of HbA1c were established based on 120-day RBC lifespan observed in adults, without considering the RBC lifespan difference between children and adults. The proposed studies will for the first time determine RBC lifespan in diabetic children

Screening visit: There will be one screening visit before the study. We will do some blood tests that will determine if the subjects can be in this study. If the subject is qualify, he/she will be asked to return for the following scheduled visits.

Study visit 1: We will draw a small amount of subject's blood from the IV. The study subject's blood will then be marked with biotin. We will give back the subject's blood marked with biotin through IV within 4 to 6 hours. Endotoxin analysis (conducted pre-infusion) and bacterial culture analysis (conducted post-infusion) will be performed. Twenty minutes after the blood transfusion, we will draw blood from the IV. After that, we will take out the IV and the subject can go home.

All follow-up study visits:

The subject will have a study visit 24 hours after receiving blood marked with biotin. After that, the subject will have a clinic visit every 7-10 days. These visits will end when we can no longer find the biotin marked blood cells in the subject's blood. This is expected to be approximately 12 weeks later.

At these visits, we will draw blood and also collect all blood glucose results in the past 7-10 days.

After the study visits are completed, there will be one follow-up visit 4-6 months after the subject receives the biotin marked RBCs. We will draw about 0.25 ml of blood.

Continuous glucose monitoring and HbA1c determination-- We will monitor continuous glucose concentrations throughout the study. This will be accomplished by setting up FreeStyle Libre Pro continuous glucose monitoring (CGM) device for each study subject. In addition, HbA1c will be measured once in the middle of the study (likely visit 6) and in the end of the study (likely visit 12).

Eligibility Criteria:
Inclusion Criteria:

* children with either type1 or type 2 diabetes between 4-18 years old

Exclusion Criteria:

* consumption of biotin supplements or raw eggs within 30 days;
* history of gastrointestinal blood loss;
* heart failure ;
* active viral or bacterial infection;
* hemoglobinopathy;
* prior history of liver disease with transaminases more than 3 times the upper limit of normal for age;
* uncontrolled thyroid disease;
* anemia (whole blood HCT\<33);
* history of renal disease (prior serum creatinine more than \>1.5 mg/dlL);
* detectable antibody to biotin.