cyrilzakka/clinical-trials huggingface dataset:
Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash

This early phase I trial studies the side effects of ketoconazole and how well it works in treating participants with ongoing EGFR inhibitor-induced rash. Ketoconazole may reduce the symptoms related to EGFR inhibitor therapy and improve EGFR inhibitor-induced rash.

PRIMARY OBJECTIVES:

I. To demonstrate that topical ketoconazole, an anti-androgen, palliates EGFR inhibitor-induced rash within a group of racially diverse cancer patients.

II. To explore the role of ribonucleic acid (RNA) sequencing to identify other targets that might be used at a later date for rash palliation.

III. To evaluate toxicities associated with topical ketoconazole.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants apply ketoconazole topically twice daily (BID) on days 1-28.

ARM II: Participants apply placebo topically BID on days 1-28.

After completion of study treatment, participants are followed up at 1 week.

Eligibility Criteria:
Inclusion Criteria:

* Patient has developed a rash or symptoms of a rash (cutaneous burning) characteristic of an EGFR inhibitor (health-care provider report of the rash with no other documentation is permitted)
* Patient is anticipated to continue for at least 28 days with an EGFR inhibitor or restart =\< 14 days of registration and continue for at least 28 days
* Mayo only: Patient is willing to provide a skin biopsy for correlative research; Note: Can be waived with permission of study chair (documentation such as an email must be provided)
* Patient must complete baseline quality of life (QOL) packet

Exclusion Criteria:

* Patient has a prior allergy or intolerance of ketoconazole
* Patient has an allergy or intolerance to sulfites
Comparison of Low-dose Ketamine to Opioids in the Management of Acute Pain in Patients Presenting to the Emergency Department With Long Bone Fractures

The purpose of this study is to establish the feasibility of initiating a ketamine pain control protocol in the emergency department for the treatment of acute pain in patients with long bone fractures and to compare the efficacy of the ketamine pain protocol to bolus morphine for pain control in the first 6 hours of patient stay in the emergency department.


Eligibility Criteria:
Inclusion Criteria:

* patients presenting to the ED with long bone fracture, open or closed.Long bone fractures include:humerus, radius, ulna, femur, tibia, fibula.

Exclusion Criteria:

* Received morphine in the ED prior to enrollment
* Received ketamine any time prior to enrollment
* Glasgow Coma Scale(GCS) less than 15
* Transferred from other facility
* Other moderate to severe trauma injuries
* Contraindication to ketamine
* Cannot consent (no intubation, airway issues, hemodynamic instability)
* Prisoners
* Suspected and/or confirmed pregnancy
Examination of ADMA Serum Level and DDAH II

Examination of ADMA (Asymmetric-Dimethylarginine)-serum level and DDAH II (Dimethylarginine Dimethylaminohydrolase)- Polymorphism in patients with severe Sepsis and septic shock as prognostic value.

This study looks into ADMA as a good prognostic factor for sepsis. Further more the dependency of the ADMA level to the DDAH II polymorphisms is reviewed this study.

Secondary targets are the mortality (28 days ICU), the length of hospitalisation in ICU and peripheral station, the severity of the illness (SAPS II score), the SOFA-score values in the progress and the procalcitonin values in the progress

Eligibility Criteria:
Inclusion Criteria:

* \>18 y/o
* sepsis
* septical shock

Exclusion Criteria:

* primary cardiogenic shock
* pregnancy
* breastfeeding
* non compliance
* moribund status
hCG Supplementation in Frozen-Thawed Embryo Transfer Cycle

The implantation rate after frozen-thawed embryo transfer cycles depends mostly on the receptivity of the endometrium and the embryo quality.The effects of human chorionic gonadotropins (hCG) on the endometrium have been investigated for several years. hCG was shown to up-regulate gene expression during the differentiation of human endometrial stromal cells into decidua. The aim of our study was to assess the benefit of hCG supplementation throughout the secretory phase of artificial frozen-thawed embryo transfer cycles.


Eligibility Criteria:
Inclusion Criteria:

* all women on frozen-thawed embryo-transfer cycle

Exclusion Criteria:

* any allergy to injection of human chorionic gonadotropin before
Investigation of a New 1-piece Convex Ostomy Product

The aim of the investigation was to investigate the performance and safety of a new ostomy product


Eligibility Criteria:
Inclusion Criteria:

* Are at least 18 years of age and have full legal capacity.
* Have had an ileostomy/colostomy for more than 3 months
* Have used a 1-piece flat ostomy product for the last 1 month
* Has given written Informed Consent and signed the letter of authority
* Have an ileostomy or colostomy with a diameter of 33 mm or less
* Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks
* Are evaluated to be suitable for a soft convex product
* If having a colostomy: changes their product on average 2 times pr. 24h or more
* Currently uses a bag of size medi/midi or maxi

Exclusion Criteria:

* Have a loop ostomy (also called double-barrel or ostomy with two outlets).
* Are pregnant or breastfeeding
* Currently receiving or have within the past 2 month received radio- and/or chemotherapy
* Currently receiving or have within the past month received systemic or local steroid treatment in the peristomal area
* Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
* Known hypersensitivity toward any of the test products
* Participating in other interventional clinical investigations or have previously participated in this investigation
* Use irrigation during the investigation (flush the intestine with water)
* Have a fistula in the peristomal area or less than 2 cm from the edge of the baseplate
* If subject has a colostomy: empties the bag
A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients

The purpose of this study is to demonstrate that a new formulation of an Bendamustine (BDM) Hydrochloride (HCl) is bioequivalent (BE) (similar) to the commercially available product in patients with cancer.

This is an open-label, randomized, crossover, Phase I study intended to demonstrate the BE, and safety and tolerability profile of 2 formulations of BDM HCl administered to cancer patients: Eagle-BDM and Teva-BDM Histologically confirmed diagnosis of any malignant disease (solid tumors and hematologic malignancies are eligible) for which no curative or standard therapy is appropriate.

At the end of the study, patients may be enrolled into an open-label extension (OLE) study (Study EGL-BDM-C-1301-OLE), at the discretion of the investigator.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of any malignant disease for which no curative or standard therapy is appropriate.
* Bone Marrow Function and Blood Chemistry results within protocol limits

Exclusion Criteria:

* CLL
* HIV
* Presence of brain metastases
Comparative Study of Specular Microscope for Cell Density, Coefficient of Variation, Hexagonality and Corneal Thickness

The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek Specular Microscope CEM-530. The secondary objective is to evaluate any adverse events found during the clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Non-Pathologic: Male or female subjects from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed. Subjects who follow the instructions by Principal/Clinical investigator or clinical staff at the clinical site, and can visit on a scheduled examination date.
* Pathologic: Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed. Subjects who follow the instructions by Principal/Clinical investigator or clinical staff at the clinical site, and can visit on a scheduled examination date and subjects who have any of the following conditions:

  * History of Post-op surgical trauma including, Psudophakic or Aphakic blous keratopathy or glaucoma surgery
  * History of corneal transplant
  * Physical injury or trauma to the cornea
  * Long term Fuch's dystrophy/Guttata (and other corneal endothelial dystrophy)
  * Keratoconus
  * Long term PMMA contact lens use

Exclusion Criteria:

* Non-Pathologic subjects who have the following conditions:

  * Long term Diabetes
  * Dementia
  * Subjects who have other life threatening and/or debilitating systemic diseases
  * History of corneal transplant
  * Long term Fuch's dystrophy (and other corneal endothelial dystrophy)
  * Keratoconus
  * Guttata
  * Diabetic retinopathy
  * History of cataract or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device.
  * All contact lens wearers
* Pathologic subjects who have Dementia or who have other life threatening and/or debilitating systemic diseases
Phase I Dose Escalation Safety Study of RetinoStat in Advanced Age-Related Macular Degeneration (AMD)

The purpose of this first in man study is to examine the safety of an experimental gene transfer agent, RetinoStat, designed to treat neovascular age-related macular degeneration.

There are two parts to the study. A dose-escalation phase looking at three doses of RetinoStat starting with the lowest dose, three patients will be recruited at each dose level. The escalation phase will be followed by a dose confirmation phase where the highest dose that is safe and well tolerated will be examined in 9 patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of AMD with active CNV that shows evidence of leakage.
* BCVA less than or equal to 20/200 in the study eye for dose escalation phase.
* BCVA less than or equal to 20/80 in the study eye for maximum tolerated dose phase.

Exclusion Criteria:

* Significant ocular abnormalities that prevent retinal assessment.
* Treatment with steroids within three months of screening.
* Treatment with anti-VEGF therapy to either eye within one month of screening.
* Clinically significant intercurrent illnesses, laboratory, ECG or chest XRay abnormalities.
Brown Adipose Tissue Activation: Effect of Exercise Training and Irisin

This study investigates the brown adipose tissue (BAT) activation and metabolism using positron emission tomography (PET) imaging before and after exercise training intervention at fasting state under normal room temperature and during cold stimulation.The investigators hypothesize that BAT glucose uptake is increased after exercise and BAT becomes metabolically more active.

Understanding the mechanisms of BAT activation and the role of exercise in humans is crucial to combat epidemic of obesity and diabetes.

Exercise training has been suggested to activate and recruit human BAT through the activation of sympathetic nervous system and contracting skeletal muscles by the release of myokines such as lactate and irisin that signal WAT to induce expression of beige adipocytes. It has been also suggested that exercise training could enhance the metabolism of already existed functional BAT by increasing uncoupling protein-1 (UCP-1) gene transcription, mitochondrial biogenesis and hyperplasia. This is of clinical relevance because brown fat activation has been found to improve metabolic factors linked to obesity and diabetes.

In this study the investigators use a PET radiotracer 2-\[18F\] flouro-2-deoxy-D-glucose (FDG) to quantify the glucose uptake in BAT, whie adipose tissue and the muscle.The participants are scanned thrice at fast in this study once at room temperature, second at cold exposure and third after six weeks of exercise at cold exposure. This study will provide an insight about the role of exercise in activation of BAT metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Healthy sedentary volunteer

  1. BMI 20-25 kg/m2
  2. Age: 18-45 years
  3. No chronic diseases

Exclusion Criteria:

1. BMI \< 20 kg/m2 or BMI \> 25 kg/m2
2. Mental disorder or poor compliance
3. Eating disorder or excessive use of alcohol or tobacco smoking
4. Any chronic disease
5. Past dose of radiation
6. Presence of any ferromagnetic objects that would make MR imaging contraindicated
7. Physically disability which rule out the physical fitness tests or participation in the exercise training intervention
8. Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation

Circulating markers to diagnose complications (sepsis, necrotizing enterocolitis) in preterm infants are often inaccurate, partly due to the lack of comprehensive studies with temporal evaluation from birth until a disease onset. The investigators plan to collect weekly blood samples of preterm infants from birth until 4 weeks of age to comprehensively characterize differential protein and epigenetic markers in infants with and without complications (sepsis, necrotizing enterocolitis, chorioamnionitis).

Preterm infants (10% incidence worldwide), especially those who do not receive sufficient mother's own milk, are susceptible to infectious diseases including sepsis and necrotizing enterocolitis. Infants with history of prenatal inflammation including chorioamnionitis may be at higher risks of acquiring these infectious diseases. Limited knowledge is available regarding a comprehensive temporal profile of circulating markers in preterm infants from birth to disease onset. This current study aims to provide a comprehensive temporal profile of circulating markers, via -omic techniques (proteomics and/or epigenetics), during the first 4 weeks of life in preterm infants with various systemic complications. Thus, this will elucidate a profile of early markers consistently associated with pathological conditions in the whole study period. Depending on the outcome, a subsequent study for validation may be performed.

Primary objective: To characterize circulating markers associated with the early life complications including chorioamnionitis, LOS and NEC in preterm infants during the first four weeks of life.

Secondary objective: To characterize how different feeding regimes and diets may affect these markers during the first four weeks of life in preterm infants

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born before the complete 32 weeks of gestation
* Signed parental consent

Exclusion Criteria:

* Major congenital anomalies or birth defects
The Possible Effect Of Amniotic Fluid pH On Neonatal Morbidities In Maternal Inflammation/Infection Associated Pregnancies

Amniotic fluid (AF) pH can be affected by the maternal and/or fetal conditions such as PPROM, prematurity or fetal distress. It is known that fetal urine is the major content of AF since 20th gestational week. Besides fetal alveolar fluid (FAF), gastrointestinal tract, umbilical cord and fetal side of placenta are important sources for AF. Bombesin-like peptides, 8-hydroxydeoxyguanosine in fetal urine and leukotriene E(4), lecithin, sphingomyelin, lamellar body in FAF are molecules acting on fetal lung maturation. Varying levels of these molecules relevant to the stage of lung maturation may constitute an association to AF pHTo detect the possible effect of AF pH on neonatal respiratory morbidities 1 milliliters of AF is aspirated during C-section before incision of membranes. pH value of AFs were analyzed by the blood gas machine (Siemens RAPIDLab®1200 Systems) of NICU. Maternal and neonatal demographic features and clinical outcomes, incidences of morbidities such as respiratory distress syndrome (RDS), transient tachypnea of the newborn (TTN) are all recorded.


Eligibility Criteria:
Inclusion Criteria:

Inflammation/infection associated pregnancies Normal healthy pregnancies

Exclusion Criteria:

Congenital abnormalities Chromosomal abnormalities Blood contaminated amniotic fluid
Total Ankle Replacement Versus Arthrodesis Trial

The purpose of TARVA is to determine whether Total Ankle Replacement (TAR) provides better clinical outcomes than ankle arthrodesis in patients aged 50-85 years with end-stage ankle osteoarthritis, and compare cost-effectiveness of the two treatments

This is a randomised, multi-centre, non-blinded, prospective, parallel-group trial of TAR versus ankle arthrodesis in patients with end-stage ankle osteoarthritis (OA) aged between 50 and 85 years, comparing clinical outcomes (pain-free function, quality of life (QoL), range of motion (ROM), and rate of post-procedural complications) and cost-effectiveness. TARVA is a clinician-led, pragmatic, superiority trial designed to compare the improvement in pain-free function, as assessed by the Manchester-Oxford Foot Questionnaire (MOXFQ) walking/standing domain score from pre-op to 52 weeks post-op for each surgical treatment group. A total of 328 patients will be randomly allocated on an equal basis to one of two surgical treatments: i) Total Ankle Replacement; and ii) Ankle Arthrodesis. Randomisation will be stratified by surgeon and presence of OA in two adjacent joints as determined by a pre-operative MRI scan.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of end-stage ankle osteoarthritis
* Aged 50-85 years inclusive
* The surgeon believes the patient is suitable for both TAR and arthrodesis (having considered deformity, stability, bone quality, soft tissue envelope, and neurovascular status)
* The patient is able to read and understand the Patient Information Sheet (PIS) and trial procedures
* The patient is willing and able to provide written informed consent

Exclusion Criteria:

* Previous ipsilateral talonavicular, subtalar or calcaneocuboid fusion or surgery planned within 1 year of index procedure
* More than 4 lower limb joints fused (including contralateral limb, but excluding proximal interphalangeal joint fusions)
* • Unable to have MRI/CT scan (e.g. severe claustrophobia or contraindication for either scan)
* History of local bone or joint infection
* Any co-morbidity, which, in the opinion of the investigator, is severe enough to; interfere with the patient's ability to complete the study assessments or; presents an unacceptable risk to the patient's safety
* Participant in another clinical trial that would materially impact on their participation in this study
The Effect of Pain Neuroscience Education

The aim of this study is to examine the effect of pain neuroscience education (PNE) on physiotherapy students' knowledge, attitudes and behaviors towards pain. A total of 52 physiotherapy students will be included in the study. Students will be randomly randomly assigned to either PNE group (n=26) or control group (CG) (n=26). The PNE group will be receive a 70-min PNE based on the explanations used in "Explain Pain". The CG group will be received an education about red-flags which are special screening questions for serious pathology. The red-flags education will be discussed tissue pathology and Waddell's triage for back pain classification.Neurophysiology and the biopsychosocial model will not be discussed. Before, immediately after, and 2-months after the education sessions all students will be completed four questionnaires, the Revised Neurophysiology Pain Questionnaire (RNP-Q), the Health Care Providers' Pain and Impairment Relationship Scale(HC-PAIRS), and the red-flags questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* volunteer to participate in study
* to studying in physiotherapy
* be able to read and understand Turkish

Exclusion Criteria:

- having received pain neuroscience education
Effect of Daily Steps on Fat Metabolism

Reduced ambulatory activity has been shown to effect the response to a high fat tolerance test (HFTT) after acute exercise. This study will evaluate the effect of varying levels of daily ambulation on response to a HFTT after an acute aerobic exercise bout.


Eligibility Criteria:
Exclusion Criteria:

* Cardiovascular problems (e.g. pre-existing heart issues, coronary artery disease, hypertension, etc.)
* Respiratory problems
* Musculoskeletal problems that prevent prolonged sitting or exercise
* Obesity
* Susceptibility to fainting
* Pregnancy
Study on the Safety and Effectiveness of the SnowyTM PFO Closure System

To evaluate the safety and effectiveness of the SnowyTM PFO closure system in plugging patent foramen ovale

A prospective, multicenter, randomized controlled clinical trial is conducted to evaluate the safety and effectiveness of PFO closure system produced by Hangzhou Dinova EP Technology Co., Ltd.., Ltd. in closing patent foramen ovale (PFO). 242 patients are expected to be selected. They are randomly divided into the PFO closure system treatment group (121 cases) and the Chinese medicine Shengjie Cardi-o-fix PFO occluder treatment group (121 cases) according to 1:1. All patients will be followed up to 7 days after operation or before discharge, 1 month, 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 to 65 years old, regardless of gender
2. Transthoracic echocardiographic contrast echocardiography (cTTE) confirmed the presence of PFO and at least moderate (see above definition) RLS (in Valsalva active/resting state)
3. Existence of at least one of the following conditions： 1) Unexplained stroke or TIA 2) intractable or chronic migraine
4. The subjects are informed of the nature of the study and agreed to all requirements for participation in the study, signed the informed consent form, and agree to complete the follow-up and follow-up examination

Exclusion Criteria:

1. Patients have definite causes of stroke unrelated to the PFO
2. RLS caused by other causes, such as atrial septal defect or pulmonary arteriovenous shunt
3. Atrial fibrillation or atrial flutter
4. Mitral and aortic stenosis or severe regurgitation
5. Dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy
6. Active endocarditis or other untreated infectious diseases
7. Left ventricular ejection fraction (LVEF) \< 40%, or NYHA cardiac function grade III-IV
8. Uncontrollable hypertension
9. Previous intracardiac surgery
10. Myocardial infarction or unstable angina pectoris within 6 months
11. Contraindications to anticoagulants or antiplatelet drugs
12. High risk of bleeding
13. severe liver function impairment（alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal value）
14. Serum creatinine greater than 2 times the upper limit of normal or with any history of renal dialysis or renal transplantation
15. Severe pulmonary disease including pulmonary hypertension (clinical diagnosis)
16. Nickel or contrast allergy
17. Active or planned (within 12 months) pregnancy, or lactating female patients
18. Malignant tumors or other serious diseases resulting in a life expectancy of less than 12 months
19. Psychiatric conditions that may interfere with medical compliance and compliance with follow-up
20. Concomitant participation in other clinical trials
21. The investigator determines that the patient is unsuitable because of reasons not listed but thought to interfere with safe trial participation