cyrilzakka/clinical-trials huggingface dataset:
Azacitidine and Interferon Alfa in Treating Patients With Metastatic Melanoma

RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Interferon alfa may interfere with the growth of tumor cells. Giving azacitidine together with interferon alfa may be an effective treatment for melanoma.

PURPOSE: This phase I trial is studying the side effects and best dose of azacitidine when given together with interferon alfa in treating patients with metastatic melanoma.

OBJECTIVES:

Primary

* Determine the maximum tolerated dose (MTD) of azacitidine in combination with interferon alfa-2b in patients with metastatic melanoma.
* Determine if the MTD of this regimen is biologically active in these patients.
* Define and describe the toxicities associated with this regimen.

Secondary

* Determine, preliminarily, the response in patients treated with this regimen.
* Describe, preliminarily, the time to progression and overall survival of patients treated with this regimen.

OUTLINE: This is a dose-escalation study of azacitidine.

Patients receive azacitidine subcutaneously (SC) once daily on days 1-5 (week 1) followed by interferon alfa-2b SC 3 days a week in weeks 2-4. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of azacitidine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic melanoma
* At least one lesion appropriate for 3 separate punch or core needle biopsies
* Must have received and failed ≥ 1 prior systemic treatment for metastatic disease

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and ALT \< 2 times ULN
* Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known allergies to azacitidine, interferon alfa, benzyl alcohol, or mannitol
* No uncontrolled infection
* No known HIV positivity
* No hepatitis B or hepatitis C infection

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 3 weeks since prior systemic therapy
* More than 4 weeks since prior radiotherapy to target lesions with evidence of progression
* No concurrent radiotherapy to target lesions
* No concurrent oral or IV corticosteroids

  * Topical creams or ocular steroid drops are allowed
Evaluating Feasibility and Effectiveness of Computerized Mathematic Training

This is a randomized controlled trial that is carried out in collaboration with Knox County Schools, using an adaptive, open-access, online math training programs as intervention and student growth in math attainment as the primary outcome over one school year.

Computational fluency and understanding of mathematical concepts are essential for students' math achievement. Attainment of math learning goals in childhood uniquely predicts life-course success and wellbeing.Thus, investing in childhood math proficiency is critically important to prepare students for solving problems and succeeding in life. In schools, math teachers are faced with increasingly complex demands but instruction time is limited. Students who are struggling may need extensive individualized practice to succeed. To that end, novel computerized training methods are used in today's schools to help students obtain crucial abilities. According to the National Association for the Education of Young Children (NAEYC), most schools have adopted digital tools in the classroom, and they are increasingly interested in providing students access to new educational resources. Such specialized programs may have the potential to enhance children's academic growth trajectories, but they are not sufficiently evaluated. Moreover, teachers may not be prepared to select and use adequate digital tools.

There are numerous online learning programs that elicit different levels of motivation in students while adhering to Common Core State Standards. Some of them are expensive for schools whereas others are free, which makes them especially attractive for socioeconomically disadvantaged areas. One of the newer, but highly used programs is Prodigy, an adaptive open-access online math training game that continuously adapts to students' progress. Prodigy is different than most other programs because of its play-based, virtual reality environment that students explore with an avatar while solving math questions. As a result, students may be highly motivated and elect to spend more time on Prodigy than on other learning programs. Prodigy is currently being used by around 26 million students and teachers in the United States and Canada (https://www.prodigygame.com/), 150 school districts in the US have implemented Prodigy as part of their math curriculum, and many districts are expected to change from other programs to Prodigy, but the program has not been evaluated so far.

The investigators' aim is to evaluate the use and effectiveness of the adaptive Prodigy math training program via a randomized controlled trial (RCT) in the Knox County Schools (KCS) district.

Eligibility Criteria:
Inclusion Criteria:

* Elementary and middle school math teachers
* Students grades 2-8

Exclusion Criteria:

n/a
Post-operative Cesarean Trial of Pain Control

This study plans to learn more about postoperative pain management after cesarean deliveries (C-sections). As a part of standard of care, the Children's Hospital Colorado's Colorado Fetal Care Center (CFCC) follows the standard Enhanced Recovery After Cesarean (ERAC) guidelines to manage pain following C-section delivery. In addition, the CFCC uses an FDA approved medical device called the ON-Q ® Pump, which continuously delivers local anesthetic medication to control pain in the area of your procedure. The local anesthetic used is bupivacaine, which is FDA approved for use to control local pain after C-sections. The CFCC has found a significant reduction in opioid use after adopting both of these procedures. The study aims to determine if the ERAC protocol or ON-Q ® Pump continuous infusion is responsible for lower opioid use by comparing bupivacaine (treatment) versus saline (placebo) groups.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients 18 years of age or older
* Patients undergoing both scheduled and unscheduled cesarean deliveries at CFCC

Exclusion Criteria:

* Active substance abuse (ex methamphetamines) determined by patient report, toxin screen, or screening physician's determination
* Current treatment for chronic pain involving opiate receptor agonism or antagonism (i.e. suboxone, methadone, naltrexone, oxycodone)
* Contraindication to neuraxial anesthesia
* Known allergies to common anesthetic medications
* Inability to consent to study procedures
* Patient receiving general anesthesia
Comparison of TOFscan and TOF-Watch SX in Pediatric Neuromuscular Function Recovery

Comparison of TOFscan and TOF-Watch SX for monitoring of neuromuscular blockade function in children

TOF ratio of TOFscan when TOF-Watch SX shows TOF ratio 0.7 with rocuronium in children during general anesthesia

Eligibility Criteria:
Inclusion Criteria:

* patients need neuromuscular blockade

Exclusion Criteria:

* contraindication of rocuronium
The Effects of Remifentanil and Remifentanil-Alfentanil Administration in Children

Sevoflurane is widely and frequently used in pediatric anesthesia due to its non-irritating airway properties, rapid induction and emergence. However, it is associated with emergence agitation (EA) in children. EA may cause injury to the child or to the surgical site and is a cause of stress to both caregivers and families. Various pharmacologic agents have been suggested to reduce EA. But the effect of remifentanil on EA is still controversial. This study was designed to compare the effects of remifentanil and remifentanil combining alfentanil on EA in children undergoing ophthalmic surgery with sevoflurane anesthesia.

One hundred and two children, aged 3-9 years, undergoing ophthalmic surgery were studied. General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane. At the time of separation from parents, separation score was recorded. When the children have a separation score of three or four point, they received half dose of thiopental before going to the operation room. They randomly assigned to group S (sevoflurane alone) or group R (sevoflurane with remifentanil infusion at the rate of 0.1 ㎍/kg/min) or group A (sevoflurane with remifentanil infusion and intravenous injection of alfentanil 5 ㎍/kg 10 min before the end of surgery). Mean arterial pressure (MAP), heart rate (HR) and sevoflurane concentration were checked every 15 minutes after induction of anesthesia. Time to extubation from discontinuation of sevoflurane inhalation was measured. Time to discharge from postanesthesia care unit (PACU) was assessed with postanesthetic Aldrete recovery score. Emergence agitation scoring system was used to evaluate the incidence and severity of EA.

Eligibility Criteria:
Inclusion Criteria:

* children who were scheduled to undergo ophthalmic surgery under general anesthesia

Exclusion Criteria:

* developmental delay, neurologic or psychologic disease,
* history of sleep apnea,
* or history of general anesthesia
Nutritional Prevention of Diabetes Mellitus Type 2

This study investigates the influence of red meat and fibers on glucose metabolism and body fat composition in subjects at increased risk for type 2 diabetes.

The epidemiologic evidence for increased red meat intake and decreased fiber intake as risk factors for T2D is solid. However, few intervention studies have been performed in order to investigate the role of whole-grain intake or the consumption of red meat in glycemic control and prevention of diabetes, yielding contradicting results. Thus, in order to prove causality, further identify potential underlying mechanisms and be able to improve lifestyle modification programs, we performed a randomized, controlled intervention study over six months. The participants are individuals at increased risk for tyoe 2 diabetes. They were randomised to 3 interventions groups: 1) caloric restriction of 400 kcal/day (control group), 2) caloric restriction plus no red meat consumption 3) caloric restriction and increase in fiber intake. Subjects where thoroughly phenotyped by anthropometric parameters, oral glucose tolerance tests, and MRI measurements of body fat composition and iron content in the liver. In this study, we want to compare the effectiveness of reduced caloric intake only versus reduced caloric intake with an additional modification of diet composition in terms of red meat and fiber consumption.

Eligibility Criteria:
Inclusion Criteria:

Individuals at a high risk for Type 2 diabetes:

* positive family history of type 2 diabetes,
* presence of metabolic syndrome,
* body mass index (BMI) \> 27 kg/m2,
* diagnosis of impaired glucose tolerance (IGT)
* previous diagnosis of gestational diabetes diabetes

Exclusion Criteria:

Main exclusion criteria

* diagnosis of type 1 or 2 diabetes mellitus
* BMI \>45 kg/m²
* presence of serious illness such as cardiovascular, malignant or psychiatric disease.
Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML) in Complete Remission

This phase 2, open label, non-randomized study will evaluate the safety of administering high dose cytarabine (HiDAC) consolidation therapy on days 1-3 of each cycle, as compared to standard administration on days 1, 3, and 5 of each cycle, in patients 61 years and older with de novo acute myeloid leukemia (AML).


Eligibility Criteria:
Inclusion Criteria:

* Both males and females ≥ 61 years of age
* A clinical diagnosis of de novo, non-M3 acute myeloid leukemia (AML) confirmed by greater than 20% blasts in peripheral blood or on diagnostic bone marrow biopsy who have completed intensive induction chemotherapy and are confirmed in complete remission #1 (defined by \< 5% myeloblasts on recovery bone marrow biopsy, Absolute neutrophil count \> 1000/uL and platelets \> 100x103/uL) and able to receive HiDAC consolidation #1
* Patients on the prospective arm must be willing to have labs/clinic visits at UF Health Shands approximately every 48 hours +/- 24 hours after discharge from chemotherapy admission to be included. If prospective subjects cannot be followed at the UF site then telephone visits are allowed to follow for toxicity and transfusions. Records can be requested from subject's local physician office.
* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures. For subjects on the historical arm, there will be a waiver of informed consent (as these patients may be deceased or not be available for retrospective consent).

Exclusion Criteria:

* Age \< 61 years
* Patients unable to provide informed consent for prospective arm
* Secondary AML (documented history of antecedent hematological disorder, such as myelodysplastic syndrome or therapy-related AML) or chronic myeloid leukemia (CML) in blast crisis
* Patients receiving, received, or who will receive a FLT3 inhibitor
* Patients receiving, received, or who will receive an IDH1 or IDH2 inhibitor
* Serum creatinine greater than 2 mg/dL
* History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician
* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness
* For historical arm, subjects will be excluded if adequate data is not available in electronic medical record (e.g., if patient was followed by their local oncologist between chemotherapy cycles and labs/transfusions/clinic notes, etc. are not available)
* Karnofsky performance status of 40 or less at study entry
The Effectiveness of "Multi-Psychological Empowerment" Courses

In the first-year project of this study, oncology nurses have reported experiencing massive stress, insufficient communication ability, and the need for communication-related training. 70% of them had moderate or higher severity of workload, fatigue, and psychological distress (at the measure point) before being provided with Basic Remote Psychological Support Course (BRPSC). A month after BRPSC, some oncology nurses have indicated/affirmed the benefits of undergoing the comprehensive psycho oncology education training courses. Thus, the second- and third-year continuation projects are focused on the development and delivery of Multi-Psychological Empowerment Courses (MPEC) for oncology nurses


Eligibility Criteria:
Intervention group

* Inclusion Criteria:
* Over 20 years old (inclusive)
* Oncology nurses currently working in clinical practice
* At least receiving one course related to oncology nurse training, such as chemotherapy for nursing staff or oncology advanced training courses.
* Exclusion Criteria:
* Those who are unwilling or unable to participate in this course training for a full one- year period.

Control group Oncology nurses who do not need to be recruited for the comparison group will be students who participated in the remote psychological support course of the first year project effective comparison groups.
Development and Verification of a New Coronavirus Multiplex Nucleic Acid Detection System

Our project intends to independently develop a fully enclosed rapid detection system for a total of 22 pathogens, including SARS-CoV-2, on the basis of the QIAstat-Dx fully automatic multiple PCR detection platform. The reasonably designed experiments are used to verify the performance of the cartridge detection and prove its clinical application value. The 22 pathogens tested in this project includes 4 coronavirus subtypes, A / B flu, parainfluenza virus, respiratory syncytial virus, etc., which is of great significance for the differential diagnosis of similar patients.

COVID-19 has not been well suppressed, and became a pandemic within 3 months globally is mainly because of the virus characteristic in the following aspects:

1. Long incubation period (average 5-7 days, up to 28 days), and the incubation period is contagious
2. Strong transmissibility, virus can be transmitted through aerosol
3. Difficulty distinguishing infected patients from other pathogenic infections
4. High negative rate of nucleic acid detection in upper respiratory tract samples of infected patients, which increases the difficulty of differential diagnosis of infection with other pathogens The existing RT-PCR nucleic acid detection kits for SARS-CoV-2 has two major problems. First, the procedure is not automated leading to higher requirements for personnel operation level and environment sterilize. What's more the kits are SARS-CoV-2 only. Once the test result is negative, it cannot help diagnose the exact pathogen in one time of experiment.

Therefore, this project intends to independently develop a fully enclosed rapid detection system for a total of 22 pathogens, including SARS-CoV-2, on the basis of the QIAstat-Dx fully automatic multiple PCR detection platform. The reasonably designed experiments are used to verify the performance of the cartridge detection and prove its clinical application value. The 22 pathogens tested in this project includes 4 coronavirus subtypes, A / B flu, parainfluenza virus, respiratory syncytial virus, etc., which is of great significance for the differential diagnosis of similar patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients went to the fever clinic with respiratory infectious symptoms

Exclusion Criteria:

* none
An Evaluation of Psychological Parameters That May Influence the Outcome Following Arthroscopy and Arthroplasty for Temporomandibular Joint Surgery

All patients undergoing arthroscopy or arthroplasty for temporomandibular joint dysfunction will complete a psychological questionnaire prior to surgery. The 3 month outcomes including pain and function will be examined using regression analysis to identify psychological variables that may predict outcomes.


Eligibility Criteria:
Inclusion Criteria:

* require arthroscopy or arthroplasty

Exclusion Criteria:

* age less than 18 yrs
* prior surgery
* unable to give informed consent
Modification of Scleral Suture Fixation of Dislocated IOL

A prospective randomized study on patients with late in the bag intraocular lens (IOL) dislocation after cataract surgery. Two surgical techniques of suturing of IOL to the sclera will be compared in the study. IOL position will be compared between those two groups, as well to a control group consisting of ordinary pseudophakia where only measurement of IOL position will be performed.

In this prospective randomized study 60 patients will be included with late intraocular lens (IOL) dislocation and 60 patients in a control group with ordinary pseudophakia. Traditional surgery includes a capsular-IOL complex fixation to sclera by looping a prolene suture not only around haptics but also through capsular tissue. Such a suture may cut through the bag, which may result in a decentered IOL. A modification of "the traditional" method was created at S:t Eriks Eye Hospital in order to achieve better centration of the IOL. The study will evaluate the efficacy of these two methods. Additionally, the impact of fibrosis of capsular bag on IOL stability postoperatively will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* patients with in-the-bag dislocated IOL who agree to participate in the study
* Inclusion criteria for the control group: pseudophakic eyes 7-10 years after uneventful cataract surgery.

Exclusion Criteria:

* patients with dislocated IOL that is not visible in the pupillary plane
* IOL design not suitable for suturing using capsular bag
* patients who are not able to cooperate under measurements
* patients with Marfan syndrome and ectopia lentis
* exclusion criterion for the control group: other eye surgery.
Comparing Exposure v Imagery Rescripting in People With OCD: a SCED

Individuals with OCD may experience intrusive future orientated thoughts and images, which are extremely distressing and interfering in life. This project aims to explore whether imagery rescripting or exposure may be a more effective intervention for individuals with OCD experiencing such images.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or over
* Main diagnosis of OCD (assessed by the Structured Clinical Interview for ICD11)
* Must report future orientated images that are distressing and ego-dystonic

Exclusion Criteria:

* Psychosis, bipolar disorder, or trauma disorder
* Current stimulant or hallucinogenic misuse, alcohol or substance misuse or dependence
* Intellectual disability, dementia, serious cognitive impairment, or organic brain disorder
* Personality Disorder as the main problem
* Active suicidality
* Concurrent engagement in other psychotherapy
* A patient may be taking anti-depressant medication so long as the dose has been stable for 6 weeks and there is no plan to increase the dose.
Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs

An intensive intervention of specially trained paraprofessionals, called community oral health specialists (COHS), administering on a quarterly basis for 2 years fluoride varnish and oral health promotion education, compared to usual care, will reduce decayed, missing, and filled tooth surface measures at 2 years for children in American Indian Head Start Programs.

The study design will be a clustered randomized design. Fifty-two head start classes in a Southwest American Indian Reservation will be randomized, 26 to the intervention program and 26 to usual care. The intervention will be comprised of specially trained paraprofessionals, called community oral health specialists (COHS), administering fluoride varnish and oral health promotion education quarterly for 2 years. Baseline and annual measures of decayed, missing, and filled tooth surfaces (dmfs) of the children, and surveys of their caregivers' dental knowledge, attitudes, and behaviors will be completed. The study will be a 5-year study, with 2 years for intake/accrual, and 3 years of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 3-5 enrolled in Head Start Centers on a Southwest Indian Reservation and having a primary caregiver (preferably mother, or the child's legal guardian as documented by the HSC)
* American Indian, as defined by the tribe, or
* Children of other racial/ethnic groups who are in the Head Start classes on the Reservation
* Parent/caregiver able to read, understand, and sign the study consent form, and
* Willing and able to follow the study procedures and instructions

Exclusion Criteria:

* Allergy to any of the components of the fluoride varnish
* Ulcerative gingivitis
* Stomatitis
* Other conditions resulting in disrupted or irritated oral mucosa
* Any other conditions or findings that, in the opinion of the investigators, would interfere with or preclude participation in the study.