cyrilzakka/clinical-trials huggingface dataset:
Complications of a Stepwise Approach for Transvenous Lead Extraction

It is an observational study of predictors of complications and difficulty of trans-venous lead extraction procedure. This procedure is done for patient who had a previous cardiac pacemaker or defibrillator implantation which had a dysfunction or infection so needed to be extracted.

The number of cardiac implantable electronic device (CIED) implantations has increased over recent years (1) with approximately 1.2-1.4 million CIEDs are being implanted annually worldwide.(2) Consequently this has been associated with increasing rates of infection and lead malfunctions, affecting approximately 1-2% of all CIED cases.(3)

Recently, it is estimated that between 10 000 and 15 000 leads are extracted worldwide each year.(4) Over the past few decades, transvenous lead extraction (TLE) has evolved as the preferred method for leads removal being less invasive compared to surgical removal by open heart surgery which is now reserved for cases with high risk procedures or a very large vegetation.

Most frequent indications for TLE are infection (accounting for 52.8%) and lead dysfunction (accounting for 38.1%) of all cases of TLE. (5)

There have been different approaches (superior and inferior approaches) and techniques for TLE. Current techniques employ mechanical and/or laser equipment with variable success rates. The locking stylet has been the principal tool in these techniques, while the telescoping (powered or non-powered) mechanical or laser sheaths serve as the most important ancillary tools.

Despite being a safe procedure with minor complications ranging from 0.06 to 6.2%, but serious complications may still arise in 0.2-1.8 % of cases in even the most experienced hands with mortality rates in several large registries amounting 0.2 - 1.2 %.(6) Although many studies have tried to identify risk factors for complications including patient/lead profile and centre/operator experience, major studies still have conflicting results.

Recently, the hybrid approach, with mini-thoracotomy or thoracoscopy, has been introduced and supposed to be associated with increased safety in challenging TLE procedures. (7, 8)

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients referred for lead extraction with class I and IIa indications according to 2017 HRS expert consensus statement on CIED lead management and extraction.

Exclusion Criteria:

* Patients primarily requiring surgical extraction
Immune Response of Caudally Administrated Tramadol In Pediatric Lower Abdominal Surgery

Management of acute pain is one of the most important tasks of perioperative pediatric anesthesia. The alleviation of pain has been defined by the Society of Pediatric Anesthesia, on its 15th annual meeting as a basic human right, irrespective of age, treatment primary service responsible for the patient care. Pro-inflammatory cytokines increased by surgical trauma indirectly modulate pain through the release of substances like nitric oxide, oxygen free radicals, prostaglandins, and excitatory amino acids, inducing peripheral and central sensitivity and hyperalgesia. There has been growing interest in determining the possible immune consequences of analgesic administration for the management of postoperative pain

60 children aged 3-10 years undergoing lower abdominal surgery will be randomized into 2 groups (30 patients in each group) to receive caudal block with bupivacaine (0.25%) 1mg/kg (group 1) plus tramadol 1mg/kg (group 2) just after the induction of general anesthesia without premedication. All children will be assessed for the post operative immune response by measuring interleukin 6 and 10 (IL-6 and IL-10) and Tumour Necrosing Factor-α (TNF-α) using enzyme-linked immunosorbent assay (ELISA) technique one hour preoperatively and three hours after incision.

Eligibility Criteria:
Inclusion Criteria:

lower abdominal operation

Exclusion Criteria:

Any systemic disease that might compromise the immune system severe coagulation disorder true allergy to local anesthetics patients with major malformations of the lower spine or meninges any cutaneous or subcutaneous lesion at the site of injection unplanned reoperation, or reoperation within three months Diabetes Melliutes
Description of Bullous Emphysema Using Lung Ultrasound and Comparison to the Characteristics of Pneumothorax

Chronic Obstructive Pulmonary Disease (COPD) is a frequent disease affecting a growing number of adults in the world which is responsible for a large public health burden through heavy morbidity and mortality.

Emphysema is one of a wide spectrum of pulmonary complications linked to COPD, defined as the abnormal permanent enlargement of the airspaces distal to the terminal bronchioles accompanied by destruction of the alveolar wall. Disease progression is correlated to worsening and enlargement of emphysema lesions, sometimes conflating in sizeable bullae, deleterious to normal mechanical pulmonary function. Bullous emphysema (BE) is sometimes eligible to invasive curative treatment through surgery or interventional bronchoscopy.

Diagnosis of BE relies on computerized tomodensitometry (CT), the gold-standard for evaluating pulmonary parenchyma. However, CT is not always available, and bullous emphysema can present as pneumothorax on chest radiography.

The practice of lung ultrasound is currently growing in respiratory medicine and emergency departments owing to an increasing amount of evidence showcasing its reliability as a diagnostic tool, most notably for pneumothorax and other pleural diseases. Despite BE having been reported to present similarly to pneumothorax in ultrasound, its characteristics have not yet been precisely described.

The primary aim of this study is to describe BE using lung ultrasound. Participants with known BE on CT will undergo a simple ultrasound examination. The secondary aim is to compare the characteristics of BE to those of pneumothorax using lung ultrasound. To achieve this, a second group of participants with currently treated pneumothorax will also undergo lung ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* Bullous emphysema group

  * Consultation or scheduled hospitalization in a Pulmonary Medicine department
  * Past medical history of emphysema on computerized tomodensitometry dating less than two years
  * Bullous emphysema with subpleural contact of two or more intercostal spaces on tomodensitometry
* Pneumothorax group

  * Hospitalized in a Pulmonary Medicine department for the treatment of a pneumothorax
  * Patent pneumothorax visible on chest x-ray dating less than 24 hours

Exclusion Criteria:

* Bullous emphysema group

  * Current pneumothorax
  * Past medical history of pleurodesis or pleural thickening homolateral to the bullous emphysema
* All patients

  * Organ failure (hemodynamic, neurological, respiratory)
  * Recent thoracic surgery dating less than 7 days with subcutaneous emphysema
  * Minor participant or otherwise deprived of their freedom or their ability to consent freely
  * No affiliation to social security
Data Collection From the CardiacSense1 and Other Modalities for Developing a System for Monitoring of Respiratory Rate

Collect data from the CardiacSense1's sensors and Capnograph, for the purpose of developing a wearable system for monitoring of Respiratory Rate (RR) in patients while at hospital

Hospitalized subjects, diagnosed with a Respiratory disease or subjects with no known Respiratory disease will be will be connected simultaneously to CardiacSense watch and Capnograph for a duration of at least 30 minutes and up to 24 hours in order to collect data for the purpose of developing a wearable system for monitoring of Respiratory Rate (RR) by the CardiacSense watch.

The CardiacSense1 is a wrist worn device designed to detect atrial fibrillation. CardiacSense1 senses the radial artery inflation and deflation and together with a PPG sensors give an ultimate performance that is superior to PPG only.

Eligibility Criteria:
Inclusion Criteria:

* Age of eighteen (18) year and above
* Diagnosed with Respiratory disease/impairment or without any known Respiratory disease/impairment
* Ability and willingness to sign an informed consent form

Exclusion Criteria:

* Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study
* Patients with significant co morbidities (assessed by the clinician at screening only
* BMI\>40
* Presence of an acute disease process that might interfere with test performance
* Subjects with PPG SNR \<100 indicated by the CardiacSense1 device
* Women who are pregnant or breastfeeding
Efficacy Study of an Educational Program for Decision Support for Breast Cancer

The purpose of this study is to develop and test an informative computer-based program to help women in making good choices among options for treating early stage breast cancer. Women who are exposed to the computerized program will, when compared to women who receive standard of care offered at the hospital: (a) be more knowledgeable about treatment options,(b) be more satisfied with their treatment decision, and (c) be more assured about their treatment choice.

The purpose of this project is to develop and test a computer-based decision support system on breast cancer for low-income women who speak English or Spanish. This project is designed to respond to the under utilization of breast conserving surgery by women with early stage breast cancer, as indicated by both national and local data on treatment choices. The literature suggests that underuse of BCS by women for whom it is the recommended therapy may relate to inadequacies in efforts to educate them about treatment options. The program was designed to convey information to women with varying levels of reading ability. This was done through multimedia approaches which include voice-over narrative in simple English or Spanish, and use of photo novella and/or "soap opera" presentation of situational material that allows women to explore possible consequences associated with different decisions.

Comparison(s): Women exposed to the computer-based decision support program on breast cancer treatment, receiving standard care and education offered at two public hospitals, compared to women exposed to standard care and education at the same public hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Breast cancer diagnosis in stages I, IIA, IIB, or IIIA
* Candidates for surgery
* Speak English or Spanish

Exclusion Criteria:

* Breast cancer diagnosis in stages 0, IIIB, or IV
* Recurrent breast cancer or inflammatory breast carcinoma
* Not eligible for lumpectomy with radiation
Clemastine in Cardiovascular Surgery

In this study, a prospective, randomized, double-blind pilot trial designed to evaluate the effect of histamine H1 receptor antagonist clemastine on perioperative anaphylaxis in cardiovascular surgery with cardiopulmonary bypass, especially for the efficacy and safety on reducing heparin and protamine associated anaphylaxis.

In this study, a prospective, randomized, double-blind pilot trial designed to evaluate the effect of histamine H1 receptor antagonist clemastine on perioperative anaphylaxis in cardiovascular surgery with cardiopulmonary bypass, especially for the efficacy and safety on reducing heparin and protamine associated anaphylaxis.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old
* Receiving selective cardiovascular surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease
* Written informed consent obtained.

Exclusion Criteria:

* Previous history of cardiac surgery
* Allergy to clemastine, antihistamines with similar chemical structure or any excipient (sorbitol, sodium citrate, propylene glycol, ethanol)
* Myasthenia gravis
* Porphyria patients
* Bronchial asthma
* Usage of monoamine oxidase (MAO) inhibitors
* Pregnant or lactating women
* Mentally or legally disabled patients
OCT Angiography in the Glaucoma Diagnosis

Glaucoma is a chronic degenerative disease of the optic nerve. It is the second cause of blindness worldwide and a frequent cause of irreversible blindness. In 2020, epidemic health authorities have predicted about 80 million glaucoma patients. Glaucoma can be treated by topical treatment (eye drops), laser or surgery. A premature diagnosis of glaucoma is very important to prevent irreversible blindness. Pachymetry, Optical Coherence Tomography (OCT) and visual fields exams are fundamental for the development of the glaucoma diagnosis. The severity of glaucoma is defined with Hodapp-Parrish-Andersen visual field criteria. According to these criteria, glaucoma can be classified as early (with average visual field deviation, MD, of 0 to -6 dB), moderate (MD of -6 to -12 dB) and severe (MD worse than -12 dB). The progression of glaucoma is being identified by the visual fields tests, and also by the progression of alterations in the optic nerve head. The visual fields tests are long and difficult (30 minutes). It is therefore important to create additional tests and anticipate the diagnosis, in order to avoid the irreversibility of glaucoma.

The OCT Angiography (OCTA) is a non-invasive technology, marketed since 2014, that uses OCT with infrared light, with no radiation nor side effects, to evaluate within seconds the vascularization of the fundus, retina and optic nerve head, which may be useful for the glaucoma diagnosis. A recent meta-analysis has shown a decrease of the vascular density (DV) in glaucoma, so that OCTA may be useful in the advanced diagnosis of glaucoma. However, the VD values obtained were different depending on the device. In addition, no studies with the OCT Triton (Topcon®) device were considered in the analysis. The authors suggested the development of dedicated software, which would allow the evaluation of VD with different devices for a more independent and valid assessment. On the other hand, recent studies show that the diagnostic capacity of OCTA may be superior to that of OCT, and that OCTA may be more useful in determining the severity of glaucoma than OCT. It is therefore necessary to evaluate the additional diagnostic tests whether they are non-invasive and whether it allow us to give a faster diagnosis.

This study is aimed at comparing the diagnostic utility of OCTA with standard complementary glaucoma examinations (OCT and CV).

Eligibility Criteria:
Inclusion Criteria:

* Patient whose age ≥ 18 years
* Patient consultant in the ophthalmology department of the Marie-Thérèse Health Center or the Polyclinique de la Baie
* French speaking patient
* Patient affiliated to a health insurance plan
* Patient having given free, informed and express consent

Exclusion Criteria:

* Patient with another ophthalmological pathology or a history of ophthalmological pathology
* Patient with a history of ophthalmic surgery except for uncomplicated cataract surgery
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Pregnant or lactating woman
Clinical Trial to Examine the Pain Relief of PH-797804 Alone Or With Naproxen in Subjects With Osteoarthritis of the Knee

PH-797804 is a potent inhibitor of inflammatory mediators that have a potential role in pain signalling following nerve injury and inflammation. Blocking such mediators may potentially have a therapeutic benefit by reducing pain.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between, and including, the ages of 18 and 75 years. Females must be of non-childbearing potential.
* Diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria with X-ray confirmation (a Kellgren-Lawrence X-ray grade of ≥2.

Exclusion Criteria:

* History of diseases other than osteoarthritis that may involve the index knee.
* Other severe pain that impairs the assessment of osteoarthritis of pain.
* Electrocardiogram abnormalities.
* History of gastrointestinal disorders.
The Effects of the Synbiotic Ecologic 825/scFOS on Intestinal Barrier Function and Immune Modulation

In the present pilot study, the investigators will study the effects of a novel synbiotic, which is a mix of probiotics (Ecologic 825) in the presence of a prebiotic (short chain fructo-oligosaccharide (scFOS)), on mucosal integrity, overall microbiota changes along the gastrointestinal-tract and the mucosal immune response. The investigators hypothesize that the synbiotic Ecologic 825/scFOS will significantly affect the intestinal permeability and modulate the immune system in humans.


Eligibility Criteria:
Inclusion Criteria:

* Based on medical history and previous self-admitted examination, no gastrointestinal complaints can be defined
* Age between 18 and 65 years
* Body Mass Index (BMI) between 20 and 30 kilogram/m2

Exclusion Criteria:

* History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, head, ears, eyes, nose, throat (HEENT), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. - Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
* Administration of probiotic supplements, investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
* Use of antibiotics in the 90 days prior to the study
* Abdominal surgery interfering with gastrointestinal function, upon judgment of the principle investigator)
* Pregnancy, lactation
* Excessive alcohol consumption (\>20 alcoholic consumptions per week)
* Smoking
* Blood donation within 3 months before or after the study period
* Self-admitted Human immunodeficiency virus-positive state
* History of any side effects towards intake of pro- or prebiotic supplements of any kind
Trial of Blue Citrus Compared to Placebo in Patients Receiving Aromatase Inhibitor Therapy for Estrogen Receptor Positive Post-Menopausal Breast Cancer

This purpose of this study is to determine if the herbal compound, Blue Citrus, decreases joint and bone pain associated with Aromotase Inhibitor therapy (AIT).

Another purpose of the study is to find out if Blue Citrus improves how you feel while taking AIT and if your quality of life improves.

Post-menopausal women currently on AIT for breast cancer treatment who self-report musculoskeletal side effects related to AIT to their physicians.

Eligibility Criteria:
Inclusion Criteria:

1. Post Menopausal - evidenced by no menses for the past 6 months or FSH level \>40
2. Patient complaints of musculoskeletal symptoms
3. Currently taking AIT for ER positive postmenopausal breast cancer

Exclusion Criteria:

1. Previously taken Blue Citrus
2. Presence of bone metastasis
3. Unable to complete VAS Pain Scale
4. Unable to comply/complete SF 12 Quality of Life survey
5. Plan to discontinue AIT in less then six months
6. Unable to complete ADL scale
7. Have diagnosis of fibromyalgia
8. Have diagnosis of rheumatoid arthritis
A Multi-center Study of Spherule-Derived Coccidioidin

Adult volunteers were skin tested with 1.27 ug spherule-derived coccidioidin. The skin test antigen was evaluated in three different populations of adult volunteers to determine the safety and efficacy of the product in the assessment of delayed-type hypersensitivity to Coccidioides immitis. Induration greater than or equal to 5 mm after 48 hours was considered positive for exposure to C. immitis.


Eligibility Criteria:
Inclusion Criteria:

* Good Health (absence of active medical disease)
* Meets criteria specific to population groups:

  * Coccidioidomycosis Group:
* History of coccidioidomycosis of at least 45 days duration confirmed by roentgenograph serologic or mycologic findings

  * Histoplasmosis Group:
* History of pulmonary histoplasmosis

  * Naive Control Group:
* Lifetime residence in the states of WA, OR, ID, or MT
* Never employed as an agricultural worker
* Serology negative for C.immitis antibodies

Exclusion Criteria (All Groups):

* Active medical disease
* Alcohol abuse or illicit drug use
* Influenza-like illness within the past 4 weeks
* Immunizations within the past 4 weeks
* Current atopic or contact dermatitis, psoriasis, erythema nodosum, urticaria
* Current treatment with corticosteroids, cytotoxic or immunosuppressive drugs
* Immunodeficiency disease
* HIV infection
* Previous skin test with coccidioidin or SD Coccidioidin
* Pregnant or lactating
* Adverse reaction to thimerosal
* Adverse reaction to Candida or Trichophyton skin test antigens

Coccidioidomycosis Group:

* Current cavitary or disseminated coccidioidomycosis
* History of histoplasmosis, or blastomycosis

Histoplasmosis Group:

* History of coccidioidomycosis or blastomycosis

Naive Control Group:

* History of coccidioidomycosis, histoplasmosis, blastomycosis
* Travel for more than 30 days in designated areas of CA, AZ, NV, UT, NM, TX and Mexico, Central and South America. Travel for more than 7 days in restricted areas of CA, AZ and TX.
Genetic Epidemiology of CVD Risk Factors

To determine the role of genetic factors influencing risk factors for cardiovascular disease, ultimately identifying specific genes influencing the age-related progression of cardiovascular disease risks.

BACKGROUND:

Understanding the genetic basis of common multifactorial diseases such as cardiovascular disease (CVD) remains an elusive goal, but the great advances in molecular genetic technology, statistical genetic methods, and phenotypic assessment of CVD risk factors in recent years have facilitated more sophisticated genetic studies of risks for heart disease.

The study is a follow-up to one conducted in the 1970's and 1980's. The availability of 5 large kindreds first identified and recruited as part of the "High Blood Pressure in the Young" program is an important resource. The investigators have an extensive array of baseline data that was collected in the late 1970s and early 1980s on 750 participants stemming from that project, although some data are available only on a subset of participants. The present study population centers on 764 individuals in five large, multigenerational, extended families (four white and one African-American) originally examined 25 years ago. Data collected from the original participants include hundreds of biochemical, medical, physiological, behavioral, physical, psychological, genetic and demographic traits.

DESIGN NARRATIVE:

The study consists of four specific aims: 1) Collect 25-year follow-up data from approximately 500 of the original participants, and new data from approximately 500 of their relatives not examined in the original study. The cardiovascular disease risk factor phenotypes to be collected include hemodynamic measures, carotid intima-media thickness, and measures of cardiopulmonary function. 2) Obtain DNA samples from these 1,000 individuals and use modern high-throughput molecular genotyping methods to create a 10 cM genetic marker map. 3) Quantify and characterize the nature of genetic influences on CVD risk factors using quantitative genetic methods suited for cross-sectional and serial (follow-up) data from relatives in large extended families. 4) Conduct linkage analyses to identify chromosomal regions (QTLs) harboring genes that influence individual variation in cardiovascular disease risk factors. Following these linkage analyses, the investigators will examine more closely the strongest linkage signals with fine mapping linkage analysis in order to narrow chromosomal regions of interest. The study is a collaboration between Wright State University and the Southwest Foundation for Biomedical Research.

Eligibility Criteria:
No eligibility criteria