cyrilzakka/clinical-trials huggingface dataset:
Out-of Pocket Payments With Lymphedema in France

Lymphedema is a frequent and chronic condition posing a high burden on patients. Clinical guidelines emphasize the role of compression therapy by prescription medical devices. Even in a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may exist due to the price and reimbursement setting processes. OOPP may threaten the equity of care and drive patients to forgo care. Our aim was to analyze the distributive effects of OOPP for lymphedema patients in France.

A prospective, multicenter study will be conducted in France in 2014 on patients with lymphedema. Household ability to pay will be specified by net income and OOPP will be assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices, nursing care, biological tests, imaging, physiotherapy and transportations). Both mandatory and voluntary health insurance reimbursements will be considered. We will combine concentration curves and concentration indices to assess the distributive effects.


Eligibility Criteria:
Inclusion criteria:

* Patient aged over six years, with primary or secondary lymphedema, regardless of the severity of the disease;
* Patient treated in one of the centres participating in the study;
* Patient (and her legal representative for minors) who gave her written consent \[or did not refuse to participate, according to local Law\] ;
* Patient with Internet access and an active email address.

Exclusion criteria:

* Patients with concomitant chronic venous insufficiency;
* Patient not covered by any health care insurance scheme;
* People protected under the law.
Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using DOSI

The purpose of this research study is to help us learn if an experimental imaging device called Diffuse Optical Spectroscopic Imaging (DOSI) can monitor tumor shrinkage during chemotherapy treatment and can predict if the tumor will respond to chemotherapy before the end of the treatment. This study will also help us understand the biological reason for how DOSI works.

There is considerable interest in developing imaging protocols to monitor and predict breast cancer response to neoadjuvant chemotherapy (NAC), which is chemotherapy given before surgical removal of the tumor, both prior to and as early as possible during the course of treatment. The efficacy and practicality of conventional imaging approaches in the NAC setting varies and identifies the need for alternate functional imaging strategies. Diffuse optical spectroscopic imaging (DOSI) is an experimental imaging method that allows patients to be followed before and during treatment with a cost-effective, bedside, handheld scanning probe. DOSI is a non-invasive technology developed at the University of California, Irvine Beckman Laser Institute. Studies will be performed at seven clinical sites on approximately 200 suspected breast cancer patients, of which 150 are expected to undergo neoadjuvant chemotherapy (NAC).

As a primary aim, the investigators will evaluate whether DOSI can predict NAC pathologic complete response (pCR), which is defined as no tumor cell left in the resected tissue at surgery) by the mid-point of the therapy regimen. As non-invasive DOSI is obtained rapidly with no risk/discomfort, this experimental imaging modality could be used as an indicator of pathologic response which has been an established indicator of long-term survival. The investigators long-term goal is to provide oncologists with a relatively simple, risk-free bedside tool that can be used to help inform medical decisions on chemotherapy regimen, duration, and timing of surgery, thereby maximizing therapeutic response and minimizing unnecessary toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Females between the ages of 21 and 80. Specific to Study part #1
* Diagnosed with a Breast Imaging-Reporting and Data System score of 4 or higher breast abnormality greater than 1cm in size Specific to Study part #2
* Enrolled in study part #1
* Diagnosed with histologically-proven invasive breast cancer
* Prescribed neoadjuvant chemotherapy for breast cancer

Exclusion Criteria:

* Pregnant
* Unable to give written, informed consent.
Olanzapine for Nausea After Surgery

Ambulatory surgery is occurring with rapidly increasing frequency as surgical and anesthetic techniques have improved and pressure to reduce health-care costs has increased. While there are many benefits to recovering from surgery within the home, a significant disadvantage is the lack of rapid access to a healthcare provider when postoperative complications occur. Postoperative nausea and vomiting (PONV) are common after surgery and anesthesia, and recent studies have demonstrated a high incidence of post-discharge nausea and vomiting (PDNV) after ambulatory surgery, particularly in high-risk groups (female gender, age less than 50 years, history of PONV, opioid administration in the post-anesthesia care unit (PACU), and nausea in the PACU). Current practices known to reduce the risk of postoperative nausea and vomiting in the PACU, such as the avoidance of volatile anesthetics and the use of intraoperative ondansetron and steroids, have little effect on the risk of delayed PDNV. Novel strategies to prevent PDNV are needed. Orally administered olanzapine, which has been shown to decrease the incidence of chemotherapy-induced nausea and vomiting, demonstrates promise as a novel strategy for preventing PDNV. It has a long half-life, allowing for a single dose to be administered preoperatively. This study will evaluate whether there is a difference in the incidence and severity of PDNV between patients who receive oral olanzapine versus placebo prior to general anesthesia for ambulatory surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adults age ≥ 18 and ≤ 50 years old
* Patient scheduled to undergo ambulatory surgery under general anesthesia
* Willing and able to provide informed consent

Exclusion Criteria:

* Unable to swallow pills
* Current use of typical or atypical anti-psychotic medications
* History of allergy to olanzapine
* Pregnancy/Lactation (subjects of child-bearing potential will have a urine pregnancy test performed the day of surgery)
* History of QTc \> 450ms or torsades de pointes
* Current use of antihypertensive medication
* Diabetes Mellitus
* Clinically significant cardiovascular disease defined as follows:

  1. Myocardial infarction or unstable angina within 6 months prior to the day of planned surgery.
  2. History of serious ventricular arrhythmia (i.e.: ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications, except for atrial fibrillation that is well controlled on anti-arrhythmic medication.
  3. New York Heart Association (NYHA) Class II or higher congestive heart failure.
* Postural hypotension or vasovagal syncope within 6 months of planned surgery.
* Hypotension on day of surgery, defined as a systolic blood pressure \< 90mm Hg or a diastolic pressure \< 60mm Hg.
* Seizure disorder
* Clinically active prolactinoma
* Hepatic disease
* Poorly controlled diabetes
* Pre-operative blood glucose \> 250 mg/dL
* Narrow angle glaucoma
* Parkinson's disease
* Lewy body dementia
Trial of Long-term Therapeutic Hypothermia for Poor-grade Aneurysmal Subarachnoid Hemorrhage

This study is a prospective, multi-centre, randomized,controlled trial to compare the efficacy of long-term mild hypothermia with normothermic intensive management in patients with poor-grade aneurysmal subarachnoid hemorrhage.

The primary hypothesis is that the induction of mild hypothermia (maintained at 32-35℃) for at least 5 days would improve the outcome of patients at six months post hemorrhage compared with normothermia.

Aneurysmal subarachnoid hemorrhage (aSAH), especially poor-grade aSAH, is a medical emergency with very high morbidity and mortality rates. SAH constitutes a major public health concern in developed and developing countries. There were several clinical trials of hypothermia for aSAH conducted, however, with conflicting results.

Hypothermia therapy treatment is currently used in our department and other large neurosurgical centers across China to decrease the intracranial pressure (ICP), mitigate some of the destructive processes, and improve the functional outcome of patients with poor-grade aSAH. When the decision was made, the patients would be placed in wrapped cooling blankets or intravascular cooling device after they were sedated, intubated and mechanically ventilated. The patients would receive continuous infusions of some drugs using an infusion pump to prevent shivering. Once the patient's rectal, nasopharyngeal or blood temperature reached 32˚C, it was kept at approximately that temperature (32-35˚C) 3 to 7 days. Then the patients were passively rewarmed to a temperature of 36 to 37˚C at a rate no greater than 0.25˚C/hour, by gradual adjustment of the blanket thermostat.

The present multi-center, randomized controlled trials is designed to investigate the efficacy and safety of long-term (3 days) mild hypothermia versus normothermia on the outcome of patients with poor-grade aSAH. The primary outcome is the neurological function assessed at 1,3, 6 months post injury with the Glasgow Outcome Score (GOS). Additionally, the following data will also be recorded and compared: the baseline data, Glasgow Coma Score,imaging examination (e.g. CT scan), intracranial pressure, laboratory tests (e.g. blood routine test, liver and kidney function, blood gas analysis, etc), the complications (e.g. pneumonia, significant bleeding) and so on.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65 years within 72 hours after subarachnoid hemorrhage;
* Neurosurgical clipping or coiling for aneurysm;
* Hunt-Hess IV-V scale;
* The intracranial pressure is more than 20 mmHg.

Exclusion Criteria:

* GCS of 3 with bilateral fixed and dilated pupils;
* No spontaneous breathing or cardiac arrest at the scene of hemorrhage;
* No consent;
* Pregnancy.
A Study on the Prophylactic Use of Antibiotics Within 72 Hours After Acute Burn Injury in Patients

The goal of this clinical trial is to compare in acute burn patients.

The main question it aims to answer are:

• what is the impact of early prophylactic use of antibiotics on prognosis Participants will be randomly divided into an antibiotic group and a non antibiotic group.

Researchers will compare the two groups to see the 72 hour wound bacterial culture negative rate.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent form
* Promise to comply with research procedures and cooperate with the implementation of full process research
* Age 18 and above
* Emergency hospitalization of patients in the burn department, within 24 hours after injury
* No immunodeficiency disease, no history of using immunosuppressive drugs, no antibiotics being used or infectious diseases at the time of admission
* If a woman is in the reproductive period, she should not be pregnant

Exclusion Criteria:

* Unable to obtain informed consent from subjects, family members, or authorized agents
* At the time of admission, antibiotics were being administered
* During pregnancy
* Presence of infectious diseases before admission
* Existence of immunodeficiency diseases or use of immunosuppressive drugs
* The subjects are currently undergoing other clinical studies
Molecular Characterization of Perivascular Epithelioid Cell Tumors

Perivascular epithelioid cell tumors (PEComas) are rare and are characterized by the expression of myomelanocytic markers. They are a complex family that includes angiomyolipomas, lymphangioleiomyomatoses and other soft tissue and visceral tumors. Due to the low prevalence of these tumors, the natural history is unclear; furthermore, a molecular classification integrating clinical, pathological and molecular parameters has not been described to date.


Eligibility Criteria:
Inclusion criteria:

* Major patient (≥18 years)
* Minor patient (1 to 17 years old)
* PEComas diagnosed in France between 01/01/1990 and 15/09/2019 and reviewed by a sarcoma referral pathologist

Exclusion criteria :

* Opposition of the patient (or the holders of parental authority) to participate in the study
* Biological tissue from a patient who does not meet all the inclusion criteria
* Classic triphasic angiomyolipoma or lymphangioleiomyomatosis
* Inability to provide informed information to the subject
* Patient under court protection
* Patient under guardianship or curatorship
Pharmacokinetic (PK) and Pharmacodynamic (PD) Modeling of Ampicillin and Gentamicin in Peripartum Patients

This study proposes to compare the metabolism of Ampicillin and Gentamicin by pregnant women to that of non-pregnant women; the placental transfer over time; and the subsequent metabolism of the transferred drug(s) in the neonate.

Pregnant women who present to Labor and Delivery will be identified as potential participants based on Inclusion/Exclusion criteria and their need to receive Ampicillin and/or Gentamicin therapy. The additional group of 20 non-pregnant women will also be identified based on Inclusion/Exclusion criteria and their need to receive Ampicillin and/or Gentamicin therapy.

Once identified, interested candidates will be fully informed of the study procedures, have all questions answered, and informed consent obtained.

Pregnant participants will receive Ampicillin 2g IV loading dose followed by 1g IV every 4 hrs until delivery; or Ampicillin 2g IV every 6hrs along with Gentamicin 5mg/kg IV every 24 hrs. Dose times will be recorded.

Non-pregnant participants will receive similar doses of either Ampicillin and/or Gentamicin, if not the same dose(s).

Fingerstick blood collection will be drawn from both populations at the following timepoints:

* before the administration of Ampicillin, and/or
* before the administration of Gentamicin
* after the full initial dose of the antibiotic has infused, at 5 min, 15 min, 30 min, 2-3hr, 4-6hr, immediately prior to the next dose of drug, and at DELIVERY (a 5 minute window for each timepoint will be permitted) If delivery occurs prior to the 3 or 6 hr timepoints, fingerstick blood collection should continue

Samples will be obtained on filter paper via the Dry Blood Spot (DBS) method, which is clinically appropriate for the purposes of this study.

Umbilical venous and arterial blood will also be drawn for sampling from the placenta after delivery, and cutting of the umbilical cord.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy, pregnant woman (28-42 weeks)
* Generally healthy, non-pregnant female
* Scheduled to receive Ampicillin and/or Gentamicin IV
* Ages 18-55 years old
* Relatively normal Comprehensive Metabolic Panel (if available), as evidenced by recent blood work
* Able and willing to sign consent

Exclusion Criteria:

* Women with known renal or hepatic impairment; preeclampsia; Diabetes, including Gestational; any medical condition that, in the opinion of the Investigator or research team member, could potentially interfere with the study objectives
* Women who are participating in another study
* Pregnant with multiples
* BMI \> 40
Study of Cardiovascular Disease and Obstructive Sleep Apnea

The purpose of this study is to determine if two medicines (allopurinol and losartan) can influence heart and blood vessel health compared to placebo in patients with sleep apnea who are using continuous positive airway pressure (CPAP).

The specific aims of this research project are: 1) Determine if treatment with losartan, an angiotensin type I receptor (AT1R) antagonist, or allopurinol, a XO inhibitor, normalize chemoreflex control of sympathetic outflow and ventilation and improve local vascular regulation and stiffness; and 2) Determine if these interventions reduce the severity of sleep disordered breathing and lower diurnal blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between ages of 21 and 65 years
* Apnea hypopnea index or respiratory disturbance index greater than or equal to 25 events per hour
* Subjects eligible for CPAP or BiPAP therapy
* Hypertension by clinical history/diagnosis (may be controlled with non- exclusionary medications) or average blood pressure \> 140/90 mm Hg (using last two measurements in prior 12 months - or 1 prior blood pressure and 1 blood pressure at screening)

Exclusion Criteria:

* If subject not using CPAP, having AHI \> 60 events/hour or oxygen saturation ≤ 65% during sleep
* Presence of clinical CV disease (coronary artery disease, angina, arrhythmias (subjects with sinus arrhythmias will be reviewed by PI for enrollment), stroke, TIA, cor pulmonale, etc.), heart failure, bruits, or diabetes mellitus by clinical diagnosis/history
* Presence of pulmonary disease that results in significant hypoxemia (resting SaO2 \< 88%)
* Hypertriglyceridemia (triglycerides \>300 mg/dL), diabetes or impaired glucose tolerance (fasting plasma glucose \> 125 mg/dL)
* Patients taking angiotensin converting enzyme inhibitors, angiotensin receptor antagonists, potassium-sparing diuretics (without accompanying loop/thiazide diuretic), allopurinol, oxypurinol, febuxostat, amoxicillin, ampicillin, azathioprine or mercaptopurine.
* Patients with chronic kidney disease (Serum creatinine \>1.5 mg/dL) or history of significant hyperkalemia (Serum potassium \> 5.2 mEq/L) with ARB therapy
* Patients with history of angioedema
* Patients with bilateral,modified radical or radical mastectomies
* Patients who have a Serum potassium \> 5.0 mEq/L at the screening visit
* Female patients who are pregnant (determined by urine pregnancy test) or breastfeeding
* Patients with active MRSA or VRE (vancomycin resistant enterococcus) infection
* History of adverse reaction to allopurinol,losartan, or zolpidem\*\*
* Patients who cannot swallow oral capsules
* Patients who are hospitalized or who have been recently hospitalized (last 2 weeks)
* Inability to comply with or complete the protocol or other reasons at the discretion of the investigators
Use of Lidocaine in Rapid Sequence Induction

Lidocaine has been shown to blunt the cardiovascular response to endotracheal intubation. The incidence of hypertension, tachycardia and dysrhythmias due to laryngoscopy may be increased in patients that receive rapid sequence induction and intubation, where opioids are spared and intravenous anesthetic agents are not titrated step by step. Our hypothesis was that lidocaine when administered intravenously in patients who undergo rapid sequence induction may not only blunt the hemodynamic response to intubation, but may also increase the anesthetic depth (as assessed by BIS), thus further reducing the possibility of hypertension, arrhythmias and also awareness.


Eligibility Criteria:
Inclusion Criteria:

* reason for rapid sequence induction (emergency, reflux),
* ASA I-II,
* no antihypertensive drugs,
* no antiarrhythmic drugs

Exclusion Criteria :
Roflumilast and Cognition

The aim of the current project is to validate PDE4 inhibitors as a target for cognition enhancers (proof-of-concept) using a translational behaviour-EEG approach. The project will demonstrate whether memory, but also attention, information processing or executive function improves with the PDE4 inhibitor roflumilast in healthy humans.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 35 years of age
* Healthy (i.e. absence of all exclusion criteria), normal static binocular acuity (corrected or uncorrected),
* Body mass index between 18.5 and 30
* Willingness to sign an informed consent.
* Positive evaluation on the memory screening

Exclusion Criteria:

* History of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological, or psychiatric illness
* First-degree relative with psychiatric disorder (in particular major depressive disorder and suicidality)
* Excessive drinking (\>20 glasses of alcohol containing beverages per week)
* Pregnancy or lactation
* Use of chronic medication other than oral contraceptives
* Use of recreational drugs in the 2 weeks preceding participation
* Smoking
* Orthostatic hypotension
* Lactose intolerance
* Sensory or motor deficits which could reasonably be expected to affect test performance
A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2009/2010 Influenza Virus Strains for the Northern Hemisphere

This study is to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female and male adults
* Aged ≥18 to ≤60 years or \>60 years on Day 1
* Written informed consent

Exclusion criteria:

* Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
* Acute febrile illness (≥38.0 °C)
* Prior vaccination with an influenza vaccine in the past 330 days
* Known hypersensitivity to any vaccine component
* Previous history of a serious adverse reaction to influenza vaccine
* History of egg protein allergy or severe atopy
* Known blood coagulation disorder
* Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
* Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity)
* Investigational medicinal product received in the past 3 months (90 days)
* Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
* Pregnancy or lactation
* Participation in another clinical trial
* Employee at the investigational site, or relative or spouse of the investigator
* Suspected non-compliance
Connective Tissue Motion Measure 2

This study aims to compare the Connective Tissue Motion Measure (CTMM) in low back pain and no-low back pain subjects, evaluate the reliability of the CTMM, and examine the correlation of CTMM with low back pain symptoms, disability, and functional measures. The investigators hypothesize that CTMM will be reduced, on average, in low back pain subjects, that CTMM will be reliable with an intra-class correlation greater than 0.8, and CTMM will negatively correlate with low back pain symptoms, disability and functional measures.


Eligibility Criteria:
Inclusion Criteria for all subjects:

* able to stand and walk without assistance
* able to read and understand English
* able to understand and sign a consent form

Inclusion Criteria for low back pain subjects:

* history of recurrent or chronic low back pain

Inclusion criteria for no-low back pain subjects:

* no history of low back pain or other chronic pain that has limited activities of daily living or work
* numerical chronic pain index of less than 0.5

Exclusion Criteria for all subjects:

* previous severe back or lower extremity injury or surgery
* major structural spinal deformity (scoliosis, kyphosis, stenosis)
* ankylosing spondylitis or rheumatoid arthritis
* neurological deficit (weakness or sensory loss, decreased deep tendon reflexes suggesting nerve root compression, but not subjective symptoms of nerve root irritation (sciatica))
* radicular pain
* neurological or major psychiatric disorder
* bleeding disorders
* corticosteroid or anticoagulant medication
* substance abuse
* pregnancy
* active worker's compensation or disability case
* in litigation for a low back pain problem
* acute systemic infection
Pradaxa (Dabigatran Etexilate) VTE Prevention After Elective Total Hip or Knee Replacement Surgery

an open, prospective, observational study to collect data on safety (major bleeding events) and efficacy (symptomatic venous thromboembolism(VTE)) of a switch from Enoxaparin to dabigatran etexilate in patients with total knee replacement (TKR) and total hip replacement (THR)


Eligibility Criteria:
Inclusion criteria:

patients age 18 years or above undergoing elective total hip or knee replacement surgery

Exclusion criteria:

according to the label recommendation for Pradaxa 220 mg QD