cyrilzakka/clinical-trials huggingface dataset:
The Validity of CORE Sensor in Heat Training for Male and Female Endurance Athletes

This study is investigating the efficacy of CORE™ devices in calculating core body temperature in athletes under varying environmental conditions.

As athletes exercise, their core body temperature rises, which can affect their performance. Additionally, repeated mild to moderate heat stress, heat acclimation, can be used to improve exercise tolerance and performance. Thus, an athlete can gain performance benefits through monitoring their heat loading while training. The aim of this study is to compare the CORE™ body temperatures recorded during exercise in two different environmental conditions in which the investigators will get a separation of core temperature and skin temperature. The investigators will accomplish this by recruiting trained and elite athletes, ages 18-59, to participate in two exercise sessions in the heat at low (10-20%) and high (80-100%) relative humidity. The investigators will compare the CORE™ temperature estimates against an FDA approved ingestible temperature monitoring device to assess the accuracy of the CORE™ devices.

Eligibility Criteria:
Inclusion Criteria:

* Highly trained or elite athlete
* Nonsmokers
* Able to read and speak English
* No underlying cardiovascular limitations

Exclusion Criteria:

* Currently or previously a habitual smoker (nicotine/cannabis)
* Pregnant, breast feeding, trying to conceive, undergoing treatment to increase sperm count
* Those taking medications that affect cardiovascular function, with the exception of oral contraceptives
* History of stroke, clotting disorders or venous thrombosis
* A history of heat illness or heat injury
* History of obstructive diseases of the gastrointestinal tract including diverticulosis, diverticulitis, inflammatory bowel disease, peptic ulcer disease, Chron's disease, ulcerative colitis, or previous GI surgery
Icotinib Combined With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation

The purpose of this study is to evaluate the efficacy of icotinib in combination with radiotherapy for NSCLC patients with brain metastases. The primary endpoint is PFS of intracranial lesions

Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases. Patients with brain metastasis showed poor prognosis and displayed an untreated median survival of only 3-6 months, and most patients died due to the progression of brain metastases. Some research showed that Icotinib alone can improve the efficiency of NSCLC with brain metastases, but there is still unknow about the result about combination with EGFR-TKI and radiotherapy. This study is designed to evaluate the efficacy of icotinib combined with radiotherapy for NSCLC patients with brain metastases.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmation of non-small-cell lung cancer (NSCLC) with brain metastases
* Histological or cytological confirmation of EGRF positive sensitive mutation
* Diagnosis of brain metastases on a Gadolinium-enhanced MRI

Exclusion Criteria:

* Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux
* Previous usage of radiation with brain
* CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
Efficacy of Peripheral Nerve Stimulator in Assessing Sensory Nerve Block Level of Spinal Anesthesia

Various methods are used to assess the level of anesthesia block after spinal anesthesia. Among them, ice cubes, alcohol swabs, and needles are commonly used in the clinical setting, but ice is limited by difficulties with management and transportation, and needle assessment has problems owing to the risk of pain, infection, and injury to the patient.

Hence, the alcohol swab is commonly used in practice. However, the absence of pain is more important in the surgical process, and assessing the pain block level is more feasible in practice than assessing the sensory nerve block level using the alcohol swab.

Therefore, it seems to be better to use the peripheral nerve stimulator for the accurate assessment of the pain block level. This has the advantage of continuous measurement of the block level, which can be used in a practical manner in conjunction with the surgical incision.

Hence, the author compared the conventional method using the alcohol swab with the use of the peripheral nerve stimulator to determine which method is more practical in the measurement of spinal anesthesia block level.


Eligibility Criteria:
Inclusion Criteria:

* The study subjects were adult patients, 20-65 years old, who were going to have orthopedic surgery on the infrapatellar area with spinal anesthesia planned and who fell under the American Society of Anesthesiologist physical status classifications of 1 or 2.

Exclusion Criteria:

* Patients who could not read or understand the consent materials or who had pregnancy, hypertension, diabetes, a defect in blood coagulation, cardiovascular disease, or administration of cardiovascular medications were excluded from the study.
Transversus Abdominis Plane Block Versus Quadratus Lumborum Block for Pain Management in Laparoscopic Appendectomy

Laparoscopic appendectomy causes postoperative pain. The primary objective of this prospective randomized controlled study is to compare the effect of ultrasound (US)-guided quadratus lumborum block (QLB) on 24-hour cumulative opioid requirements with transversus abdominis plane (TAP) block.

168 patients (ASA I-II-III) between 18 and 65 years of age, who were to undergo laparoscopic appendectomy, were randomized and divided into two groups. 32 patients were dropout for different reasons.(68 patients in each of the TAP block and QLB block groups). TAP block was performed for TAP group and QLB block was performed for QLB group. Postoperative analgesia was provided by intravenous tramadol hydrochloride using a patient-controlled analgesia device. 24-hour total tramadol hydrochloride consumption was primary outcome measure.Postoperative numeric rating scale values were the secondary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* Ages of 18-65
* Patients who will undergo laparoscopic appendectomy
* ASA I-II-III patients

Exclusion Criteria:

* Clinically known local anesthetic allergy
* Morbid obesity (body mass index\>40 kg m2)
* Clinically diagnosis of opioid, alcohol and substance dependence
* Clinically diagnosis of psychiatric disease
* Coagulopathy
* Patients with ASA IV-V
Fibrous Dysplasia, McCune-Albright Syndrome Patient Registry

The FD/MAS Patient Registry is an IRB-approved research study that that invites the patients and families to help answer some of the biggest questions about FD/MAS by completing questionnaires about their lives with FD or MAS.

Have you enrolled in the FD/MAS Patient Registry yet? Are you up-to-date on your surveys? Take a trip to www.fdmasregistry.org today to learn more about the project, enroll, complete your surveys, or make sure you aren't due to provide more info!

The FD/MAS Patient Registry: Your story powers research.

The FD/MAS Patient Registry is an IRB approved research project that allows patients and families to share their experiences with fibrous dysplasia/McCune-Albright syndrome (FD/MAS) by completing a series of surveys.

The surveys were created in collaboration with patients, parents, clinicians and researchers, so that the data can be used to answer some of the most important questions about FD/MAS, including:

the way the disease develops over time (its "natural history"), the patient experience of the disease, and its impact on quality of life, how and when diagnoses are made, the scope of treatments in use, what surgical techniques work best, and for whom, what other medical interventions work best, and for whom, what social services and therapies are useful, the costs of care to patients and their families, issues that concern patients (such as the impact of pregnancy on FD, or children feeling different and facing stigma), and which research questions and support programs you think are important to fund.

Participation is free and convenient for people with FD/MAS and their legal guardians. You can join today at www.fdmasregistry.org.

Eligibility Criteria:
Inclusion Criteria any one or more of the following:

* clinical diagnosis of fibrous dysplasia
* clinical diagnosis of McCune-Albright syndrome
* clinical diagnosis of Mazabraud's syndrome
Lipid-poor Adrenal Masses: Evaluation With Chemical Shift MRI

The purpose of this study is to determine if certain MRI sequences can accurately diagnose adrenal masses of unknown origin.


Eligibility Criteria:
Inclusion Criteria:

* Patients can participate in this study if they are 18 years of age or older and if they have had a Cat Scan (CT scan) performed with and without contrast media (medication given intravenously to enhance the CT images) or if patients are scheduled to have a CT scan performed and if the reason their physician ordered the CT is because they have an adrenal mass of an unknown type.

Exclusion Criteria:

* Patients, who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator.
* Pregnant patients or patients who are lactating.
* A patient who is claustrophobic and would require sedation to complete the MRI exam.
Correlates of Electrophysiological Activities in Different Pelvic Floor Muscle Groups and Female Pelvic Floor Function

The study aimed to explore and quantify functional and electrical activities in different pelvic floor muscle groups, to differentiate the electrophysiological role in different pelvic floor muscle groups relating to pelvic floor dysfunction or disorders, and further to develop treatment strategies for different pelvic floor muscle groups in different female pelvic disorders.

Female pelvic floor disorders including sexual dysfunction, urinary incontinence, fecal incontinence, and pelvic organ prolapse are relating to the function of pelvic floor structures. Essential components responsible for pelvic floor function include bony, muscular, and fascial structures of the pelvis. Among above components, pelvic floor muscles, either the superficial or deep group, are considered crucial in maintaining the morphology and functional integrity of the pelvic floor.

Inspection and digital examination incorporating Oxford grading system during pelvic examinations are the most convenient and commonly methods applied to evaluate the function of pelvic floor muscles. Nevertheless, both methods cannot provide quantitative information of pelvic floor muscle contraction. With the introduction of pelvic floor manometry and electrophysiological testing, quantification of pelvic floor muscle contractions can be expected.

The study aimed to explore and quantify functional and electrical activities in different pelvic floor muscle groups, to differentiate the electrophysiological role in different pelvic floor muscle groups relating to pelvic floor dysfunction or disorders, and further to develop treatment strategies for different pelvic floor muscle groups in different female pelvic disorders.

Eligibility Criteria:
Inclusion Criteria:

* Women with pelvic floor dysfuntion

Exclusion Criteria:

* Pregnant women
* Women with histories of diabetes, cerebrovascular diseases, neurological diseases, degenerative muscular diseases, or autoimmune connective tissue diseases。
A Pilot Study of Edoxaban in Patients With Non-Valvular Atrial Fibrillation and Left Atrial Appendage Closure

This is a single arm, open label, single site study assessing the feasibility of post-procedural edoxaban therapy in atrial fibrillation (AF) patients after clinically indicated WATCHMAN left atrial appendage (LAA) closure.

This is a single site, PI initiated pilot study. This study will enroll up to 75 patients who are clinically indicated for a Left Atrial Appendage (LAA) closure with the commercially available WATCHMAN device. Subjects will be enrolled if they meet study inclusion/exclusion criteria and have a successful LAA closure. All patients enrolled in the study will receive 6 weeks of edoxaban therapy. At 6 weeks post LAA closure a Transesophageal Echocardiography (TEE) will be performed. If the result is acceptable, edoxaban will be discontinued and the patient will be treated with dual antiplatelet therapy (aspirin and clopidogrel) until 6 month follow-up. After study completion, patients may be treated with aspirin monotherapy according to the FDA instructions for use for the WATCHMAN device, or according to operator discretion.

Eligibility Criteria:
Inclusion Criteria:

* The patient has documented paroxysmal, persistent, or permanent non-valvular AF (i.e., the patient has not been diagnosed with rheumatic mitral valve disease).
* LAA closure with the WATCHMAN device is planned
* The patient fulfills the FDA indication for WATCHMAN LAA closure
* The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial
* The patient is able and willing to return for required follow-up visits and examinations.
* The patient is 18 years of age or older

Exclusion Criteria:

* Conditions other than atrial fibrillation that require anti-coagulation (e.g., a prosthetic heart valve)
* Stroke within the previous 7 days
* Hypersensitivity to edoxaban
* Moderate or severe mitral stenosis
* A need for aspirin at a dose of \>81 mg a day
* A need for on-going treatment with dual antiplatelet therapy with aspirin and clopidogrel
* A need for on-going treatment with ticagrelor or prasugrel
* No LAA closure device implanted during procedure
* Procedural complication of LAA closure (e.g., stroke, systemic embolism, bleeding, vascular complication \[e.g., groin hematoma \>10cm, AV fistula, or pseudoaneurysm), or serious pericardial effusion)
* Planned surgery or invasive procedure within 6±2 weeks of enrollment
Functional Outcome Following Fracture of the Distal Radius

Patients attending the University Hospital Coventry UK with a broken wrist requiring an operation, will be invited to enter the study. At the first visit, they will have an xray of the wrist and will be asked to complete a number of questionnaires. The questions are to determine if they normally have pain in the wrist and how well they can perform their daily activities. The patient will then have an operation, and the fracture in the wrist will be held in the correct position with either a metal plate and screws or wires.

At 6 weeks following the operation the patient will be reassessed and an xray will be taken. At 3 months, 6 months and 12 months after the operation patients will perform tests to assess the strength of their grip, pinch and movement of their wrist. In addition they will complete the the same questionnaires from their first visit. At the 12 month visit patients will have another xray.


Eligibility Criteria:
Inclusion Criteria:

* Sustained a dorsally displaced fracture of the distal radius, which is defined as a fracture within 3cm of the radio-carpal joint
* The treating Consultant surgeon believes that they would benefit from operative fixation of the fracture
* Aged over 18years (either sex) and able to give informed consent

Exclusion Criteria:

* The fracture extends more than 3 cm from the radio-carpal joint
* The fracture open with a Gustillo grading greater than 1
* There are contra-indications to general anaesthetic
* There is evidence that the patient would be unable to adhere to trial procedures or complete questionnaires
A Standard Music Program Compared to an Optimized Music Program

The trial will test whether a standard music program that is an offset to the general program provides the same benefit as a music program that is individually customized for each test participant. The trial seeks to investigate the benefit received by musicians that regularly play an instrument and belong to an organized music group or orchestra instead of people that listen to music.

The initial goal of hearing aids is to amplify speech and facilitate speech understanding especially in noise. Besides speech difficulty, people with hearing loss also report a reduced enjoyment of music. The hearing aid settings used for amplifying speech often have adverse effects on music.

For this study, the sponsor will carry out testing with participants with hearing loss to compare dedicated music programs. The current study will compare the standard music program available in the software to one that is fine-tuned for each subject. The hearing aids that will be used for the study are certified by the European Conformity and have been on the market for almost one year. The goal is to determine whether musicians will perceive a difference and prefer a fine-tuned music program over the default music program in real-life situations.

Eligibility Criteria:
Inclusion Criteria:

* All classifications of hearing loss (sensorineural, conductive, mixed)
* If conductive or mixed, approval for amplification by a physician is needed
* All shapes of hearing loss (flat, sloping, reverse slope, notch)
* Severity ranging from mild to profound
* German or French speaking
* Play a musical instrument
* Ability and willingness to sign the consent form

Exclusion Criteria:

* Normal hearing
* Contraindications for amplification
* Active ear disease
* Don't play an instrument
* Inability to follow the study procedures due to language problems, psychological disorders, dementia, or other cognitive problems
* Unable to attend study appointments due to reduced mobility
* Reduced ability to describe auditory impressions and usage of hearing aids
* Uncooperative so that it is ot possible to record a valid audiogram
* Severely reduced dexterity
* Central hearing disorders
* Sponsor employees
* Family members of employees of the Sponsor
Ultrashort GnRH Agonist/Antagonist Versus GnRH Antagonist IVF

The purpose of this study is to evaluate the appropriate controlled ovarian hyperstimulation (COH) protocol in good prognosis patients undergoing IVF treatment. The stimulation characteristics of cycles which include ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist will be compared to the flexible multidose GnRH antagonist protocol.

The investigators hypothesized that combining the stimulatory effect of GnRH agonists and immediate suppression of the GnRH antagonist in a unique protocol may be a valuable new COH strategy for IVF patients, resulting in improved ART outcome.

The ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist protocol during COH cycle resulted in a significantly higher clinical pregnancy rate in patients with poor embryo quality, with repeated IVF failures and in poor responders. This protocol combines the effect of the microdose flare on endogenous follicle stimulating hormone (FSH) release with the benefit of an immediate luteinizing hormone suppression of the GnRH antagonist.

The basic hypothesis of this approach can also benefit IVF patients with good prognosis without compromising the ability to use gonadotrophin-releasing hormone (GnRH) agonist to effectively trigger ovulation, while completely eliminating any threat of clinically significant ovarian hyperstimulation syndrome (OHSS).

The purpose of the study is to compare cycles consisting of ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist with those using the flexible multidose GnRH antagonist protocol

1. To compare the IVF outcome variables and ongoing pregnancy rates.

Eligibility Criteria:
Inclusion Criteria:

* Up to three previous IVF attempts

Exclusion Criteria:

* Patients with poor or no response in previous COH for IVF cycles
* Abnormal ovarian reserve test i.e. anti-mullerian hormone (AMH), Antral follicle test
* Risk factor for Diminished Ovarian Reserve
The Effects on Growth and Tolerance of an Infant Formula Fed to Term Infants

This clinical trial will evaluate an investigational infant formula with a probiotic to determine if it provides normal growth and if it is well tolerated by term infants compared to a marketed routine infant formula.


Eligibility Criteria:
Inclusion Criteria:

* Singleton, 12-16 days of age at randomization
* Term infant with birth weight of a minimum of 2500 grams
* Solely formula fed
* Signed Informed Consent and Protected Health Information

Exclusion Criteria:

* History of underlying metabolic or chronic disease or immunocompromised
* Feeding difficulties or formula intolerance
Protego DF4 Post Approval Registry

The purpose of this registry study is to confirm the long-term safety and reliability of the Protego DF4 right ventricular lead.


Eligibility Criteria:
Inclusion Criteria:

* Implanted within the last 30 days or candidate for implantation of a BIOTRONIK ICD or CRT-D DF4 compatible system along with the Protego DF4 lead
* Meets ICD or CRT-D system implant recommendations as defined in guidelines published by relevant professional societies
* Able to understand the nature of the registry and provide informed consent
* Available for follow-up visits on a regular basis at the investigational site for the expected 5 years of follow-up
* Age greater than or equal to 18 years

Exclusion Criteria:

* Enrolled in any investigational cardiac device trial
* Planned cardiac surgical procedures or interventional measures within the next 6 months
* Expected to receive heart transplantation or ventricular assist device within 1 year
* Life expectancy of less than 1 year
* Presence of another life-threatening, underlying illness separate from their cardiac disorder
* Patients reporting pregnancy at the time of enrollment
Cancer Center Trials: Reasons for Low Accrual Rates at One Academic Institution Vs. The Community Setting

1. To identify reasons for low patient recruitment numbers to clinical trials in a cancer research center setting (and a community setting) in order to attempt to increase accrual rates.
2. To review the screening sheet for women who considered participating in the study of Tamoxifen and Raloxifene (STAR) for the prevention of breast cancer in high risk women through the University of New Mexico in Albuquerque from 1999 through 2004

Objective 1: All new cancer patients seen for a four month period at the University of New Mexico Cancer Research and Treatment Center (UNM CRTC) (academic population) and for a six month-period at the New Mexico Cancer Care Alliance (NMCCA) (community setting). A careful screening log will be kept during this period with the research nurses cooperation in documenting 1) whether patients seen were accrued to a clinical trial, 2) what available trials the patient might possibly be eligible for, and 3) the reason for not registering on to a clinical trial.

Objective 2: To compare the responses to questions on the entry forms of those women who were eligible and declined participation to those who participated by Hispanic versus non-Hispanic ethnicity, we will access, copy, and analyze all the risk assessment profiles otherwise known as entry or eligibility forms completed by women who considered participating in the study of Tamoxifen and Raloxifene (STAR). Patterns of eligibility criteria and risk assessment will be described by ethnicity of women considered for entry into this chemopreventive randomized trial without the use of personal identifying data in accordance with the Health Insurance Portability Accountability Act of 1996 to maintain patient confidentiality

Eligibility Criteria:
Inclusion Criteria:

* Women who considered participating in the study of Tamoxifen and Raloxifene (STAR) for the prevention of breast cancer in high risk women through the University of New Mexico in Albuquerque from 1999 through 2004

Exclusion Criteria:

* Not specified.