cyrilzakka/clinical-trials huggingface dataset:
Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)

RATIONALE: Naproxen may help prevent or lessen bone pain caused by pegfilgrastim. It is not yet known whether naproxen is more effective than a placebo in preventing bone pain caused by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy.

PURPOSE: This randomized phase III trial is studying naproxen to see how well it works compared with a placebo in preventing bone pain caused by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy.

OBJECTIVES:

Primary

* To compare the efficacy of daily administration of naproxen vs placebo in preventing or reducing the severity and duration of pegfilgrastim-induced bone pain (PIBP) in patients with non-hematologic malignancies undergoing chemotherapy.

Secondary

* To identify potential risk factors for the development of PIBP.
* To identify potential clinical predictors for the response or failure to respond to naproxen in preventing PIBP.
* To assess the toxicity of naproxen when administered in the preventive setting.

OUTLINE: This is a multicenter study. Patients are stratified by Clinical Community Oncology Program (CCOP) site. Patients are randomized to 1 treatment arm vs placebo.

* Arm I: Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
* Arm II: Patients receive matching placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a non-hematologic (non-myeloid) malignancy
* Scheduled to receive chemotherapy; chemotherapy may be given for adjuvant, neoadjuvant, curative, or palliative intent
* Scheduled to receive the first dose of pegfilgrastim (Neulasta®) to ameliorate chemotherapy-induced neutropenia
* Creatinine ≤ 1.5 times upper limit of normal
* Able to understand English
* More than 6 months since prior surgery on the heart

Exclusion Criteria:

* Pregnant or nursing
* Clinical evidence of active gastrointestinal bleeding, prior gastrointestinal bleeding, or gastric or duodenal ulcers
* Allergy to naproxen
* Prior development of the triad of asthma, rhinitis, and nasal polyps after taking acetylsalicylic acid (aspirin) or other NSAIDs
* Concurrent nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, or any product containing naproxen (e.g., Naprosyn, EC-Naprosyn, Anaprox, Anaprox-DS, Naprosyn suspension, or Aleve), on a regular basis
* Concurrent steroids on a regular basis
* Concurrent prescription or non-prescription medications for preexisting chronic pain; concurrent cardioprotective doses (≤ 325 mg/day) of aspirin allowed
* Concurrent therapeutic doses of warfarin
Clinical Application of CTC in Operable Breast Cancer Patients

The investigators aim to evaluate the possibility of clinical application of CTC detection in samples or peripheral blood of breast cancer patients, so as to act as the new techniques or indicators of early diagnosis, therapy efficiency, or postoperative surveillance of breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.
* Age of at least 18 and at most 70 years.
* Performance status (Karnofsky-Index) \>80%.
* Chemotherapy is necessary before or after surgery.
* No clinical evidence of local recurrence or distant metastases.
* Complete staging work-up within 3 months prior to registration. All patients must have (bilateral) mammography or breast MRI, chest X-ray; other tests may be performed as clinically indicated.
* Life expectancy of at least 2 years, disregarding the diagnosis of cancer.
* Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.
* Patients must be available for and compliant to treatment and follow-up.
* Patients registered on this trial must be treated and followed up at the participating center.

Exclusion Criteria:

* Known hypersensitivity reaction to the investigational compounds or incorporated substances.
* Local recurrence and/or metastasis of breast cancer.
* No need of chemotherapy.
* Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.
* Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix).
* Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled high risk arrhythmias.
* Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.
* Concurrent treatment with other experimental drugs or any other anti-cancer therapy.
* Males.
Pappalysin 2 (PAPP-A2) Enzyme Replacement

This study evaluates the transfusion of fresh frozen plasma containing the enzyme PAPP-A2 into the a female adult. This female adult has a mutated version of PAPP-A2 that prevents the unbinding of IGF-1 from IGF binding proteins. The investigator's hypothesize that transfusion of plasma with donor PAPP-A2 will lead to the unbinding of IGF-1 from its binding proteins and that they will be able to measure free IGF-1 in the blood of this female adult.

PAPP-A2 is a plasma protease that is known to cleave IGFBP-3 and IGFBP-5. It is thought that this cleavage frees up IGF-1 from its bound form allowing it to become the active free IGF-1. The participant has short stature accompanied with elevated plasma levels of both IGF-1 and IGF binding protein 3 (IGFBP-3). Genetic analysis of the participant identified a novel missense mutation in PAPPA2 (Ala1033Val). This gene is a perfect candidate to explain our patients' phenotype. The investigators' hypothesis is that loss of activity of PAPP-A2 leads to an inability to cleave the IGF binding proteins and thus an overall elevation in IGFBP-3 and consequent elevation in total IGF-1. However, this IGF-1 cannot be freed up and is thus not able to be active leading to short stature. The patient's missense variant is predicted to be damaging by in silicon prediction models such as Polyphen2. Furthermore, two knock out mouse models of PAPPA2 as well as a zebrafish knock out exist, all showing growth retardation (post-natally in the mice). Taken together, this is definitive evidence that the patients' mutation in PAPPA2 is responsible for their short stature phenotype.

Eligibility Criteria:
Inclusion Criteria:

* Homozygous for a defect in PAPPA2.

Exclusion Criteria: None
Long-term Follow-up in Patients Included in the European Sleep Apnea Data Base (ESADA)

The European database ESADA, containing data from more than 30,000 patients with very different severities of obstructive sleep apnea (OSA) syndrome, prospectively collects data from patients referred to academic sleep laboratories in many European countries (https://esada.med.gu.se/). Since 2007, Grenoble is one of the two French centers with Paris and is a very active participant in this European database for patient inclusion and data exploitation.

The first objective of the "ESADA Follow-up and outcomes" project is to collect cardiovascular events during the follow-up of patients in the European database through telephone interviews and a structured questionnaire. Other objectives are to collect metabolic events, incident cancers and deaths in the same population using the same mean.

An additional objective is to assess the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

The European database ESADA prospectively collects data from patients referred to academic sleep laboratories in many European countries (https://esada.med.gu.se/). Since 2007, Grenoble is one of the two French centers with Paris and is a very active participant in this European database for patient inclusion and data exploitation. A partnership agreement exists between University Hospital Grenoble (CHUGA) and ESADA for the reuse of CHUGA data. The data collected at CHUGA as part of the ESADA-Follow-up and outcomes questionnaire are also collected in the other European centers and will be centralized at the level of the coordinating center.

ESADA currently contains data from more than 30,000 patients with very different severities of obstructive sleep apnea (OSA) syndrome. One of the main limitations of this cohort is the relatively limited amount of information concerning the long-term follow-up of the patients included in the registry.

The first objective of the "ESADA Follow-up and outcomes" project is to collect cardiovascular events during the follow-up of patients in the European database through telephone interviews and a structured questionnaire. Other objectives are to collect metabolic events, incident cancers and deaths in the same population using the same mean.

An additional objective at the end of this data collection is to aggregate the follow-up data of more than 10,000 patients from all participating European centers to assess the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

Eligibility Criteria:
Inclusion Criteria:

* already included in the ESADA European database

Exclusion Criteria:

* refusal to participate
Evaluation of Spectra Optia Red Blood Cell Exchange in Sickle Cell Patients

The purpose of this study is to evaluate the performance of the Spectra Optia system red blood cell exchange (RBCx) protocols (exchange and depletion/exchange) in study participants with sickle cell disease.

Evaluate the performance of the Spectra Optia system red blood cell exchange (RBCx) protocols (exchange and depletion/exchange) in study participants with sickle cell disease. Open label design.

Eligibility Criteria:
Inclusion Criteria:

* At least 12 years old
* Enrolled in a program of regular red blood cell exchange (RBCx) to prevent symptoms/complications of sickle cell disease (SCD) or Initiating a program of regular RBCx or Receiving RBCx as a pre-surgical procedure.
* Medically stable
* Previous documentation of diagnosis by hemoglobin electrophoresis of a type of sickle cell disorder requiring RBCx.
* Sufficient vascular access to accommodate the RBCx procedure as determined by the apheresis technician performing the procedure or phlebotomist responsible for obtaining intravenous access.
* Availability of sickle trait negative, leukoreduced, ABO blood group, Rhesus factor D (Rh (D)) compatible, unexpired replacement blood. See Glossary for definition of replacement blood.
* Able to commit to the study follow-up schedule.
* Agree to report adverse events (AEs) during the required reporting period.

Exclusion Criteria:

* Inability to obtain informed consent/assent from patient, or permission from parent or guardian.
* Pregnancy (negative serum pregnancy test required for females of childbearing potential).
* Life expectancy is fewer than 30 days from time of procedure.
* Incarcerated or a ward of the court.
* Refusal of blood products.
* Failure to comply with site standard requirements for cessation of medications (e.g., angiotensin converting enzyme (ACE) inhibitors) that interfere with or increase risk of RBCx procedures.
* History of drug or alcohol abuse that, in the opinion of the investigator, could affect the ability of the patient to comply with the study requirements Inability to comply with the protocol in the opinion of the investigator.
Role of Rosiglitazone on Pre-Diabetes Mellitus and Coronary Artery Disease

Objectives:

The investigators examined whether rosiglitazone, a thiazolidinedione (TZD), is beneficial for pre-diabetes mellitus (DM) adults with documented coronary artery disease (CAD).

Background:

Microvascular and macrovascular complications are common in type 2 DM. There is no evidence about the effects of TZDs, synthetic peroxisome proliferator-activated receptor (PPAR)-γ activators (insulin sensitizers and adipose transcriptional regulation and anti-inflammatory process activators) on pre-DM patients with documented CAD.

Materials and Methods:

This is a randomized, double-blind, placebo-controlled study, patients will be randomly assigned to the TZD group and to the placebo group with a 6-month treatment period.

Biomarkers will also examined before and 6 months post-treatment during the trial.

The primary end-points will be the diagnosis of major cardiovascular events: myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD.

Eligibility Criteria:
Inclusion Criteria:

* documented CAD by angiography
* insulin resistance or glucose intolerance
* 18 to 80 years of age

Exclusion Criteria:

* under DM treatment
* allergy to TZD
* active inflammation
* chronic disease under NSAID treatment
* active heart failure
* unwilling or unable to sign inform consents
Acupuncture vs. Core Stability Training in Women With Fibromyalgia

This study analyse the effectiveness of a core stability training Physiotherapy programme versus Acupuncture treatment for the management of balance and functional capacity impairments of women with Fibromyalgia.

Objective:

This study investigated the effectiveness of a core stability training Physiotherapy programme versus Acupuncture for the management of balance and functional capacity impairments of women with Fibromyalgia.

Design:

A single-blind randomized clinical controlled trial.

Setting:

University of Extremadura and Olivenza Fibromyalgia Association, Spain

Subjects:

Women with Fibromyalgia and balance impairment.

Interventions:

135 Participants were randomized to a core stability training physiotherapy programme group (n=45), an acupuncture treatment group (n=45) and control group (n=45) for 13 weeks.

Main Measures:

Measures were taken at baseline (week 0), post intervention (week 6) and at follow up (week 13). The primary outcome measures were static balance (posturography) and dynamic balance and functional mobility (Berg Balance Test, Time Up and Go test and 10-metre walk) and functional capacity (Fibromyalgia Health Assessment Questionnaire (FHAQ) and the physical function item from the Spanish Fibromyalgia Impact Questionnaire (SFIQ)).The secondary outcome measure were quality of life (Spanish- Fibromyalgia Impact Questionnaire), pain, joint stiffness, difficulty to work and depression (measured with the visual analogue scale).

Eligibility Criteria:
Inclusion Criteria:

* women between 18 and 71 years old,
* diagnosed with Fibromialgia by a specialized physician,
* having subjective sensation of balance impairments.

Exclusion Criteria:

* The exclusion criteria were to present any medical contraindication for acupuncture and/or physiotherapy, phobia of needles, adverse reactions to medication that could influence in balance, associated pathologies such as alcoholism or severe visual deficit, to have receive acupuncture or core stability based physiotherapy in the two months previous to the intervention and to do physical exercises that train core stability such as Pilates or Yoga
Complementary and Alternative Medicine in Patients With Inflammatory Bowel Disease. A Cross Sectional Study in Norway.

The purpose of this study is to investigate the proportion of use of complementary and alternative medicine (CAM) in patients with inflammatory bowel disease (IBD). In addition, the reason for, and satisfaction with use of CAM.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years and with verified diagnosis of Crohn's disease or ulcerative colitis attending an outpatient clinic in a Norwegian hospital.

Exclusion Criteria:

* Patients \<18 years.
Heparin's Influence on ROTEM® Analysis

Coagulopathy with transfusion requirements is frequent during cardiac surgery with cardiopulmonary Bypass. Rotational thromboelastrometry (ROTEM®) is a viscoelastic whole blood point of care test used to assess the patient's coagulation status.

The purpose of this study is to evaluate the feasibility of ROTEM® analysis in the presence of very high heparin concentrations as seen during cardiopulmonary bypass.

The Society of Cardiothoracic surgeons suggest that 50% of patients undergoing cardiac surgery have a blood transfusion.

Several studies indicate an increase in morbidity and mortality related to blood transfusions.

Traditionally, the coagulation tests are performed in the hematology laboratory.

Rotational thromboelastrometry is a useful method of assessing perioperative coagulation function in patients undergoing cardiac surgery.

The presence of significant amounts of heparin in blood samples during cardiopulmonary bypass induces artifactual errors when thromboplastin is used as a reagent. For this reason, whole blood coagulation monitoring with ROTEM® has not been feasible during cardiopulmonary bypass with heparin anticoagulation. Recently recombinant thromboplastin has come available. It's stability is guaranteed by the manufacturer for plasmatic heparin concentrations up to 5UI/l .

Three of the available ROTEM®-tests are EXTEM (activation by recombinant thromboplastin), INTEM (activation by elagic acid) and HEPTEM. In the latter, heparinase, added to the INTEM reagent, eliminates heparin to reveal underlying coagulopathies.

The purpose of this study is to evaluate the feasibility of ROTEM® analysis in the presence of very high concentration of heparin and to evaluate whether heparinase could reverse heparin's effect on EXTEM and INTEM during cardiopulmonary bypass.

Arterial blood samples were drawn for analysis after induction of anesthesia (T0),10 minutes after the administration of heparin (T1), at unclamping of the aorta (T2) and after heparin reversal with protamine (T3). The following tests will be performed: EXTEM, INTEM, HEPTEM and a heparinase modified EXTEM. For the latter, recombinant thromboplatin instead of the elagic acid is used in the HEPTEM test. Heparin concentrations are measured at T1 and at the end of bypass (T2). HEPCON® was used for heparin management.

Eligibility Criteria:
Inclusion Criteria:

* Patients ungergoing coronary artery bypass grafting using cardiopulmonary bypass
* Patients from 18 to 85 years old.

Exclusion Criteria:

* Patients incapable to consent.
* Known coagulopathies or platelet dysfunction.
* Patients treated with antiplatelet drugs other than aspirin.
* Patients treated with anti vitamine K anticoagulants.
* Patients treated with heparin less than 6 hours prior to surgery.
Assessment of Cardiopulmonary Function in Duchenne Muscular Dystrophy

This study seeks to develop and validate non-invasive assessments of cardiac and respiratory muscles with magnetic resonance imaging (MRI) to better predict the natural disease progression of Duchenne muscular dystrophy (DMD) in affected individuals over time, as well as determine whether peripheral skeletal muscle dysfunction can predict cardiopulmonary dysfunction. The central hypothesis is that non-invasive MRI measures of the heart, muscle, and peripheral skeletal muscles can sensitively predict future cardiopulmonary decline.

Magnetic Resonance Imaging (MRI) of the heart and breathing muscles, special breathing tests (called pulmonary function testing), special exercise tests (using a stationary bike), and possibly an echocardiogram (ultrasound of the heart, commonly known as an "echo") will be completed up to 4 times per year for up to 4 years. Most participants will complete testing once or twice each year; however, some participants will be asked to repeat some of the tests twice during each visit.

Eligibility Criteria:
Inclusion Criteria:

* Male
* 5-15 years old at the time of enrollment
* Diagnosed with DMD (as defined by parent project)
* Written parental informed consent (and assent where appropriate) before any study procedures take place

Exclusion Criteria:

* Contraindication to an MRI examination
* Presence of a secondary condition that impacts muscle function or metabolism, that leads to developmental delay or impaired motor control, or that is not stable
* Participant is unable to comply with study requirements
* Congenital structural abnormality of the heart, repaired or unrepaired
* Clinically contraindicated participation
Observatory of Screening Aneurysms of the Abdominal Aorta During Echocardiography. National Epidemiological Survey

Study of the prevalence of Abdominal Aortic Aneurysms (AAA) (\> 3 cm) in patients with echocardiography (transthoracic or) during a specific day, with cardiologists in France.

This is a cross-sectional epidemiological investigation, assembling evidence from a routine ultrasound screening for AAA at the waning of echocardiograms performed during a specific day.

The study will be offered a list of centers selected by the Scientific Committee in the complete list of locations being in France, the subsidiary of echocardiography Echocardiography of French Society of Cardiology. These centers will be 500 in number representative of the French centers, geographically and by type of centers.

Multicenter observational study collecting data from a routine ultrasound screening for AAA at the waning of echocardiograms performed during a specific day. All of the cardiologists practicing echocardiography are invited to participate in this study, each cardiologist should include echocardiography in 10 patients examined for any reason and will be considered referring cardiologist.

There will be no follow-up, the idea is to have a database with measures of abdominal aortic aneurysms and therefore.

Eligibility Criteria:
Inclusion Criteria:

* Any patient \> 65 years,
* Have an echocardiogram, whatever the reason,
* Having agreed to participate in the study.

Exclusion Criteria:

* Patients already operated in the aorta (AAA, PAD, stent, ...)
* Patient refusal to participate in the study
Acupuncture for Low-Dose Opioid for TKA Replacement

The majority of patients undergoing total knee replacement(TKR) rely on opioids for postoperative analgesia. These medications have undesirable side effects and potential for abuse and addiction. The aim of this cohort study is to determine the incidence rate of patients who are able to maintain a low dose opioid regimen after TKR with the use of a multimodal approach that includes intraoperative auricular acupuncture protocol.

This is a prospective cohort study to assess the feasibility of patients to undergo TKR while adhering to a low-dose opioid regimen by using a multimodal analgesic approach that includes intraoperativeauricular acupuncture. We hypothesize that it will be feasible to maintain a low-dose opioid regimen during TKR while followingthe intraoperative auricular acupuncture protocol, and that patients will be satisfied with their pain control with a low incidence of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* ASA of 1 or 2
* Age 18-70
* Undergoing primary total knee replacement
* Desire to attempt a low opioid or opioid free pathway

Exclusion Criteria:

* NonEnglish speaking
* Patients with the inability to understand or follow study protocol
* Opioid use in the last 6 weeks or chronic pain patient
* Cannot receive neuraxial anesthesia and/or peripheral nerve block
* Patients with contraindications to intraop protocol (e.g., patient cannot take acetaminophen or ketorolac due to liver or kidney disease)
* Patients with implanted cardiac device such as a pacemaker or AICD
* Active ear infection
* Nonnative ear, previous scarring or surgical manipulation of ear
* Patients with gauges or other deforming ear piercing (small nondeforming ear piercings are ok) present in ears
* Allergy to nickel