cyrilzakka/clinical-trials huggingface dataset:
Prediction of Arterial Lactate and Blood Gas Values Through the Analysis of Central Venous Blood

Predicting arterial lactate and blood gas values with sufficient accuracy by simply analyzing central venous blood would be interesting in intensive care unit patients in whom the insertion of an arterial catheter or arterial punctures could be avoided. This prospective study aims at externally validating published mathematical models built to predict arterial values from central venous blood analysis.

Mathematical models for predicting arterial blood gas and arterial lactate have recently be published (PMID 27543529; see the citations section). The aim of the study is to externally validate these models in a multicenter (11 centres in France) cohort of intensive care unit patients suffering from acute circulatory failure. For the peru pose of the study, patients will undergo concomitent central venous/arterial blood sampling from 1 to 4 times during their intensive cafe unit stay. Clinical characteristics of the patients and central venous blood gas and lactate values will be used to predicted arterial values according to previously published formula. Predicted and actual arterial values of each variable of interest (pH, PaCO2, SaO2, lactate) will then be compared.

Eligibility Criteria:
Inclusion Criteria:

* age\>18 years
* patient admitted in a intensive care unit
* patient already carrying an indwelling arterial catheter and a superior vena cava central catheter
* patient presenting an acute circulatory failure defined by the presence of at least two of the following items: a) Persistent hypotension (systolic arterial blood pressure \< 90 mm Hg or mean arterial pressure \< 65 mm Hg) or need for continuous intravenous vasopressor treatment (at any dose). b) Presence of at least one of the following signs of hypoperfusionfusion :Change in mental status ; Skin mottling ; Oliguria (Urine output \<0.5 ml/kg body weight for at least one hour); Arterial lactate \> 2 mmol/l or peripheral venous lactate \> 3.2 mmol/l; ScvO2 \<70%.
* Routine medical management requires central venous blood sampling for ScvO2 measurement and arterial blood sampling for gazometry.

Exclusion Criteria:

* Opposition to participation in the study
* Impossibility to take a concomitant arterial and venous gazometric sample.
* Patient treated with ECMO (extracorporeal membrane,oxygrnation), intermittent dialysis or continuous dialysis during sampling
* Patient hospitalized without consent and/or deprived of liberty by court decision.
Precision Palliative Care for Patients with Advanced Esophageal Cancer

The goal of this clinical trial is to learn if precision palliative care improves survival of patients with advanced esophageal cancer in adults.

Researchers will compare precision palliative care and standard palliative care to see if precision palliative care works more effectively to treat advanced esophageal s cancer.

Participants will receive precision palliative care or standard palliative care. All participants will answer survey questions about their quality of life, MDASI, PHQ-9, GAD-7 for 1 years.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Aged ≥18 years
3. Histologically confirmed esophageal cancer
4. Clinical stages IV based on the 8th AJCC TNM classification, or recurrent esophageal cancer
5. plan to treated with PD-1 immunotherapy
6. Eastern Cooperative Oncology Group(ECOG) performance status: 0-2
7. Adequate organ functions Absolute neutrophil counts (ANC) ≥1.5×109⁄L; Hemoglobin (Hb) ≥9g⁄dl; Platelet (Plt) ≥100×109⁄L; Total bilirubin ≤1.5 upper limit of normal (ULN); Aspartate transaminase (AST) ≤2.5 ULN; Alanine aminotransferase (ALT) ≤2.5 ULN; Creatinine ≤1.5 ULN.

Exclusion Criteria:

1. Esophageal perforation or hematemesis
2. Any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism and hypothyroidism (effective hormone replacement therapy excepted)) and immunosuppressive agents or systemic hormonal therapy indicated within 28 days (for adverse events of chemoradiotherapy excepted).
3. Disease progression occurs within 3months after PD-1 immunotherapy.
4. Allergic to macromolecular protein preparations, or to any of the ingredients in PD-1 inhibitors for injection.
5. Uncontrolled heart diseases or clinical symptoms, such as: (1) New York Heart Association(NYHA) class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4)clinically significant arrhythmia requiring clinical intervention.
6. Congenital or acquired immunodeficiency (such as HIV infection); active hepatitis B (HBV-DNA≥104 copy number/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method); active tuberculosis.
7. Active infection or unexplained fever \>38.5 °C within 2 weeks before randomization (fever due to tumor excepted, according to investigator).

   Patients with fertility reluctant to take contraceptive measures during the trial, or female patients pregnant or breastfeeding.
8. According to the investigator, other factors that may cause termination of the study. ie, other serious diseases (including mental illness) require combined treatment, family or social factors, which may affect the safety or the collection of trial data.
Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer

To determine if hypofractionated radiotherapy to the whole breast (4,250 cGy/16 fractions over 22 days) is equally effective to standard fractionated radiotherapy (5,000 cGy/25 fractions over 35 days) in women with node negative breast cancer who have undergone lumpectomy.

The primary outcome is local breast recurrence and secondary outcomes include morbidity and cost effectiveness.


Eligibility Criteria:
Inclusion Criteria:

1. The female patient has a histological diagnosis of invasive carcinoma of the breast, and no evidence of metastatic disease.
2. Has had a lumpectomy (including segmental resection and partial mastectomy), that is, surgical excision of the tumour with a rim of normal tissue.
3. Patient has not had an axillary dissection, OR for patients who have had an axillary dissection, all nodes are negative for metastatic disease.

Exclusion Criteria:

1. Tumour greater than 5 cm in greatest diameter on pathological examination.
2. The presence of invasive or intraductal (noninvasive) breast cancer involving the surgical margins.
3. Clinical evidence prior to surgery of infiltration of the skin of the involved breast such as edema, ulceration, or fixation of the tumour to underlying muscle, or inflammatory breast cancer.
4. Bilateral malignancy of the breast (synchronous or metachronous).
5. More than one primary invasive tumour in the same breast.
6. Previous surgery for breast cancer.
7. Pathological status of axilla is unknown.
8. Status for adjuvant systemic therapy not determined.
9. For patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 16 weeks of last surgical procedure on the breast.
10. For patients treated with adjuvant chemotherapy: unable to commence radiation therapy within 8 weeks of the last dose of chemotherapy.
11. Serious nonmalignant disease (eg. cardiovascular, renal, etc.) which would preclude surgical or radiation treatment.
12. Currently pregnant or lactating.
13. Breast deemed too large to permit satisfactory radiation (ie. separation \> 25 cm).
14. Previous concomitant malignancies of any type except squamous, or basal cell carcinomas of the skin, or carcinoma \\fIin situ\\fR of the cervix which have been effectively treated.
15. Geographic inaccessibility for follow-up.
16. Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
Conditioning Treatment With Umbilical Cord Blood Transplant for Hematologic Malignancies

This is a phase II study to assess the day 180 event free and overall survival after administration of a specified combination of fludarabine, busulfan, Total Body Irradiation (TBI), and thymoglobulin reduced intensity conditioning and 2 unit UCB stem cell transplant in a single institution setting in patients with hematologic malignancies for whom allogeneic transplantation is indicated.


Eligibility Criteria:
Inclusion Criteria:

Subjects 18-70 years old. ECOG 0-2

Patients must have a diagnosis of one of the following:

* Chronic Myeloid Leukemia
* Acute Myeloid Leukemia
* Acute Lymphoblastic Leukemia
* Hodgkin's Disease
* Non-Hodgkins Lymphoma
* Myelodysplastic Syndromes
* Myeloproliferative Disorder

Patients must have adequate visceral organ function

* Patients must furnish written informed consent and HIPAA authorization for release of personal health information.
* Patients must be able to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments.

Exclusion Criteria:

* Patients who have a histocompatible sibling-matched donor age 18 to 65 years in good health who is willing to donate stem cells are ineligible.
* Patients who are pregnant are ineligible.
* Patients are ineligible if they have received cumulative chemotherapy doses in excess of: carmustine (BCNU) 400 mg/m2, and/or a cumulative anthracycline exposure in excess of 550 mg/m2 doxorubicin (Adriamycin®) unless gated-pool radionuclide cardiac scan shows greater than/equal to 45% ejection fraction.

Patients who are HIV or HTLV-I, -II antibody sero-positive are ineligible.
High Tech and High Touch (HT2): Transforming Patient Engagement Through Portal Technology at the Bedside

A large-scale randomized control trial (RCT) of the impact and use of an inpatient tablet-based patient portal embedded in a larger mixed methods study to examine changes in patient experiences and outcomes, and subsequent ambulatory patient portal usage.

The appropriate use of technology to actively engage with patients who suffer from multiple chronic conditions, called multimorbidity, is one of the frontiers of both research and practice. For multimorbid patients, engagement in disease management activities is particularly critical, and evidence shows that enhanced patient self-management can lead to better control of chronic illness. One tool finding increasing use is the patient portal, and its pervasiveness is supported by virtue of its role as a component of the Meaningful Use criteria. A patient portal is a tethered personal health record (tPHR) that links to the patient's electronic health record, facilitating communication and engagement activities with healthcare providers. While most tPHRs have been focused on outpatient activities, a new class of tools focused on the inpatient experience has begun deployment in 2014.

In response, this study supports the conduct of the first, large-scale randomized control trial (RCT) of the impact and use of an inpatient tablet-based patient portal embedded in a larger mixed methods study to examine changes in patient experiences and outcomes, and subsequent ambulatory patient portal usage. The investigators aim to study how access to a patient portal tailored to the inpatient stay can improve patient experience and increase patient engagement by improving patients' perception of the process of care while in the hospital (patient experience), increasing patients' self-efficacy for managing their chronic conditions (patient engagement), and facilitating use of a patient portal for care management activities after discharge (patient engagement).

The study site is a world-class healthcare facility with the ability to provide access to a patient portal designed specifically for the inpatient experience, bridging to outside the hospital after discharge.

Currently, this inpatient technology exists in only one other hospital in the US, but the investigators expect that as inpatient PHRs become more readily available, the need for clarity on this issue will only increase. The investigator's evaluation is a mixed-methods design consisting of primary data collection through surveys and interviews throughout the study period, and secondary data collection from the electronic health record and health system metadata. This study will offer insight into a potentially important mechanism to facilitate patient self-management.

Eligibility Criteria:
Inclusion criteria:

* patient accepted MyChart Bedside tablet
* patient available in their room
* capable of providing informed consent

Exclusion criteria:

* Patient in a pilot unit where Full Tech was available prior to study start
* Patient was less than 18 years of age
DAHANCA 33: Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic HNSCC

Aim: To improve curability of radiotherapy in HNSCC patients identified by hypoxic FAZA-PET scanning

Prospective phase II study aiming to improve the outcome in hypoxic resistent patients identified by FAZA-PET.

Inclusion:

Patients must fulfill the following:

Positive hypoxic FAZA-PET Scanning (as described in DAHANCA 24 - see citation) Stage III-IV, Squamous cell carcinoma of the larynx, pharynx or oral cavity (HPVneg (oropharynx) Indication for hyperfractionated accelerated radiotherapy with concommitant cis-platin and nimorazole

Eligibility Criteria:
Inclusion Criteria:

* Stage III-IV larynx, pharynx, oral cavity
* Hypoxic FAZA-PET positive
* Indication for primary radio-chemotherapy
* Informed consent

Exclusion Criteria:

* HPV positive oropharynx cancer
* Primary surgery
Ultrafast Ultrasound for the Functional Assessment of the Diaphragm

The aims of the current study are as follows:

i) Investigate the relationships between indices derived from ultrafast ultrasound imaging and Pditw, ii) Investigate the relationships between indices derived from ultrafast ultrasound imaging and diaphragm EMG, iii) Investigate the performance of ultrafast ultrasound for the diagnosis of diaphragm dysfunction, iv) Investigate the ability of ultrafast ultrasound imaging to decipher the cause of diaphragm dysfunction i.e. contractility alteration and/or phrenic nerves conduction defect.

The Neuromuscular Physiology and Evaluation Laboratory of the Institute of Myology recently reported that artificially stimulated diaphragm contraction may be captured and quantified using ultrafast ultrasound imaging. By filming the diaphragm at very high frame rate, one may extract ultrasound indices such as diaphragm thickening fraction and diaphragm tissue velocity. The same team showed that these indices, in particular, maximal diaphragm tissue velocity were strongly reliable and related to Pditw in healthy subjects. This approach bridges the gap between non-volitional (that are commonly combined with internal pressure measurements) and non-invasive procedures. Whether the relationships between indices derived from ultrafast ultrasound and Pditw exist in patients presenting with actual or suspicion of diaphragm dysfunction remains to be specifically investigated. Similarly, the potential of this approach for the diagnosis of phrenic conduction abnormalities remains to be assessed as it may help to circumvent confounding factors associated with surface EMG.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Patients with confirmed diaphragm dysfunction or suspicion
* Written informed consent
* Able to comply with all protocol requirements
* Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

* Known allergy to latex
* Known allergy to Lidocaine or similar product
* Pacemaker
* Guardianship/trusteeship
* Pregnant or nursing women
Cephea Early Feasibility Study

The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more appropriate than open heart surgery.


Eligibility Criteria:
Key Inclusion Criteria:

* Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm²) per American Society of Echocardiography criteria.
* LVEF ≥ 30%
* In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery.

Key Exclusion Criteria:

* Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
* Need for emergent or urgent surgery.
Transforaminal Lumbar Interbody Fusion in PEEK Oblique Cages With and Without Titanium Coating

Clinical outcome with regard to oswestry disability index and lumbar fusion rate after implantation of titanium coated PEEK cage and common PEEK cage

Cages made of polyetheretherketone (PEEK) and titanium materials reliably produce successful fusion rates and good clinical outcomes. However, there is a paucity of studies that have assessed the optimal material of cage systems. The primary objective of this study was to compare the Oswestry Disability Index (ODI) after instrumented transforaminal lumbar interbody fusion (TLIF) using either titanium-coated polyetheretherketone (TiPEEK) or common PEEK cages. Secondary objectives were to assess differences in fusion rates and differences in pain and in quality of life between these groups.

Eligibility Criteria:
Inclusion Criteria:

Persistence of

* low back pain,
* sciatica and
* spinal claudication after conservative treatment attributed to L3 to L5 lumbar segments.

Exclusion Criteria:

* previous lumbar spinal surgery
* body mass index \>35 kg/m²
A Study to Evaluate the Bioequivalence of an Oral Suspension Formulation, an Oral Solution Formulation, and the Marketed Tablet Formulation of Levofloxacin in Healthy Subjects

The primary objective of the study was to assess the bioequivalence of the oral suspension formulation, the oral solution formulation, and the marketed tablet formulation of levofloxacin, with the marketed tablet as the reference.

In this single-dose study conducted at at single center, 3 oral formulations of levofloxacin (tablet, suspension, and solution) were assessed for their bioequivalence in healthy men and women aged 18 to 55 years old. Subjects were assigned different treatments based on chance; both the researcher and the study participant knew the treatment being administered. The study consisted of a screening period, 3 open-label treatment periods separated by washout periods of at least 4 days between doses, and a post-treatment period. Subjects received a single dose of all 3 study formulations, administered as a single dose of each formulation on Day 1 of each treatment period. Blood samples were collected on Days 1, 2, and 3 of each treatment period immediately before dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 10, 14, 24, 30, 36, and 48 hours after dosing for measurement of levofloxacin concentration. Subjects were admitted to the study site prior to dosing and remained through the 48-hour measurements on Day 3. The post-treatment period included physical examination and clinical laboratory testing to ensure subject safety before being discharged from the study. Safety evaluations, including adverse event monitoring, standard clinical laboratory evaluations (hematology, serum chemistry, and urinalysis), vital sign monitoring, and physical examinations, were monitored throughout the study.

Two cohorts of 36 subjects each were enrolled in the study. The first cohort received a single dose of study drug and completed Period 1; the study was then stopped and reinitiated. Subjects from the first cohort completed early termination procedures; their data were included in safety analyses, however, no blood samples for levofloxacin concentrations were analyzed or included in pharmacokinetic analysis. Thirty-four subjects in the second cohort completed all study procedures. Levofloxacin oral suspension (125 mg/5 mL), levofloxacin oral solution (125 mg/5 mL), and levofloxacin tablet (500 mg) administered on Day 1 of each treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Aged 18 to 55 years
* BMI between 18 and 30 kg/m2
* No prescription or over-the-counter medications for previous 14 days
* Negative tests for drug and alcohol abuse, HIV, hepatitis B and hepatitis C
* and Healthy based on medical history, physical examination, 12-lead electrocardiograms, toxicology, antigen, and antibody screens, and clinical laboratory evaluations

Exclusion Criteria:

* Allergic reaction to quinolones
* Clinically significant ECG or clinical laboratory abnormalities
* Creatinine clearance \<=80 mL/min
* Acute illness within 7 days
* Nicotine use within 1 year
* Receipt of experimental drug or device within 60 days
* Pregnant or breastfeeding
Detection of Ileoanal Pouch/Reservoir Adenomas

The detection of adenomas is the basis for the follow-up of patients with familial adenomatous polyposis, after colectomy, with a remnant rectum or an ileal pouch. The optimal method for the adenomas detection is not defined yet. Despite the proven effectiveness of indigo-carmine in different indications dye chromoendoscopy is not used in a consensual way at the international level. The situation of the ileal pouch is specific as adenomas have a usually flat shape and are much more difficult to identify than in the situation of a remnant rectum, even in the situation of \> 5 mm adenomas that should be resected.

Our hypothesis is that indigo-carmine can improve adenomas detection, including \> 5 mm adenomas, in patients with a an ileal pouch after colectomy improving the effectiveness of surveillance programs and potentially reducing the risk of cancer in this population.


Eligibility Criteria:
Inclusion Criteria:

* Patients with familial adenomatous polyposis
* Ileo-anal anastomosis with pouch reservoir
* Quality of the final preparation = 3 (excellent) on the studied area
* Films made under optimal conditions for the 3 staining methods

Exclusion Criteria:

* Patient with no familial adenomatous polyposis
* Patient without Ileo-anal anastomosis reservoir
* Insufficient quality of the final preparation \<3
* Absence of films made under optimal conditions for the 3 staining methods
Quality of Life in Patients Treated With Leadless Pacemakers

The study aims to carry out a domestic multi-center, prospective, non-randomized, non-blinded post-approval study to assess health-related QoL between Micra TPS and conventional PM implantation. Meanwhile, pocket and leads related complications would also be evaluated between these two strategies.


Eligibility Criteria:
Inclusion Criteria:

* With an age arranged from 18 to 80 years old;
* Conforming to indication of a pacemaker implantation;
* Life expectancy\>1 year;
* Normal cardiac function with preserved LVEF;
* Adequate self-care ability or self-help skills before pacemaker implantation;
* Mentally healthy so as to participate in the quality-of-life assessments;
* Willing to participate in study through consent and willing to undergo study specific required procedures with expectancy of geographically stable for follow up duration.

Exclusion Criteria:

* Subject with indication for ICD/ CRT-P/CRT-D;
* Subject with persistent symptomatic sinus bradycardia;
* Subject has an existing or prior pacemaker, ICD or CRT device implant;
* Subject has unstable angina pectoris or has an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment;
* Subjects with a mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD);
* Subjects with a life expectancy of less than 12-months;
* Subjects with medical condition which precludes patient from participation in the opinion of the investigator, such as arthritis, lung disease or previous stroke, renal dysfunction, recent major surgery within six months, clinically overt congestive heart failure;
* Pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence;
* Psychological disorders unable to participate in the quality-of-life assessments.