cyrilzakka/clinical-trials huggingface dataset:
SKLB1028, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

The purpose of this study is to describe the dose limiting toxicities (DLT) of SKLB1028 when combined with cytarabine/ daunorubicin remission induction in a 7+3 schedule. Safety and tolerability of SKLB1028 will also be evaluated. This study will also characterize the pharmacokinetics (PK) of SKLB1028 when given in combination with cytarabine/daunorubicin remission induction and high-dose cytarabine (HiDAC) consolidation therapy in newly diagnosed acute myeloid leukemia .


Eligibility Criteria:
Inclusion Criteria:

1. Subject has a diagnosis of previously-untreated de novo acute myeloid leukemia (AML) \> 20% blasts in the bone marrow according to WHO classification (2016) documented prior to enrollment.;
2. Age ≥ 18 and \< 60 years;
3. Subjects who are positive for FLT3 mutations by central laboratory;
4. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
5. Subject must meet the following criteria as indicated on the clinical laboratory tests;

   1. Serum aspartate aminotransf
   2. Total serum bilirubin ≤ 2.5 x institutional ULN
   3. Serum creatinine ≤ 3 x institutional ULN or an estimated glomerular filtration rate (eGFR) of \> 30 ml/min
6. Subject is suitable for oral administration of study drug.

Exclusion Criteria:

1. Confirmed diagnosis of acute promyelocytic leukemia (M3 /APL), or BCR-ABL positive leukemia (ie, blast crisis of chronic myelogenous leukemia);
2. Diagnosis of active malignancy other than AML;
3. AML secondary to radiotherapy or chemotherapy for other tumors;
4. AML with central nervous system involvement;
5. Refractory hypokalemia or hypomagnesemia that is not easily corrected by symptomatic treatment and that occurs repeatedly in the past;
6. Current clinically significant graft-ve
7. Previous history of other malignancies.
8. Patients with clinically significant coagulation abnormalities, such as disseminated intravascular coagulation (DIC), hemophilia A, hemophilia B, and von Willebrand disease;
9. Major surgery of major organs has been performed before entering the study (for the definition of major surgery, refer to Grade 3 and 4 surgery specified in Management Measures for Clinical Application of Medical Technology, or the patient has not yet fully recovered from
10. Subject has received prior therapy for AML with the following exceptions: a. emergency leukapheresis; b. emergency treatment with hydroxyurea ;c. growth factor or cytokine support; d. steroid for anaphylaxis or transfusion reaction;
A Trial to Compare the PK and PD of Insulin Lispro Administered Into Different Tissues in Subjects With Diabetes Mellitus Type 1

The aim of this trial is to compare the pharmacokinetics and pharmacodynamics of insulin lispro injection into either lipohypertrophic lesions or normal tissue, utilizing both state-of-the-art euglycaemic clamp and mixed meal tolerance testing. The magnitude of insulin efficacy after injection into these different areas is still unclear. The results from this study may expand the knowledge on the severity of this issue and may provide evidence for future treatment recommendations regarding injection sites for insulin administration.


Eligibility Criteria:
Inclusion Criteria:

* AUCINS.0-4h and AUCGIR.0-4h during treatment period 1

Exclusion Criteria:

* AUCINS.0-4h and AUCBG.0-4h during treatment period 2, intra-subject variability of AUCINS.0-4h and AUCGIR.0-4h during treatment period 1
Placental Passage of Free and Esterified Phytosterols in Humans

Total plasma cholesterol rises by 60 % with progressing pregnancy in humans. Because lipid-lowering drugs are contraindicated during pregnancy, natural compounds, such as phytosterols, may be a safe and effective alternative to prevent undesirable effects. Information on phytosterols in pregnancy is so far very limited. To date, to the best of our knowledge, no studies have characterized the maternal-fetal gradient of free and esterified phytosterols in full-term human pregnancy. For this purpose, maternal and cord blood cholesterol and non-cholesterol sterol (campesterol, stigmasterol, sitosterol) concentrations were measured in term pregnant women at delivery by using gas chromatography-mass spectrometry.


Eligibility Criteria:
Inclusion Criteria:

* A single pregnancy
* A gestational age determined from known last maternal menstrual period higher than 37 weeks
* A normal diet without phytosterol supplementation during pregnancy
* Written informed consent available.

Exclusion Criteria:

* Major congenital anomalies
* Maternal history of cardiovascular disease
* Endocrine disorders such as diabetes, hypercholesterolemia, pre-eclampsia, thyroid or adrenal problems
* Clinical chorioamnionitis
Hydronephrosis After Anterior Lumbar Interbody Fusion (ALIF)

Anterior lumbar spinal surgery involves making an incision through the abdomen of the patient in order to access the spine. During this process, several internal structures are pushed aside in order to gain access. One of these structures is the ureter, whose function is to drain urine from the kidney to the bladder. One potential complication that can arise from this is dilation of the kidney - known as hydronephrosis. The aim of this study is to identify whether hydronephrosis after Anterior Lumbar Interbody Fusion (ALIF) is complication, in order to bring this to the attention of health care professionals when considering this kind of surgery.

A total of 40 patients who have had ALIF surgery will be invited to have an ultrasound scan of their kidney on the side where the operation was performed (where the scar is). Should hydronephrosis of this kidney be detected, the investigators will go on to scan the second kidney. Should hydronephrosis be detected the patient will be given a letter to take to their General Practitioner (GP) advising them to be referred to a Urologist.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Has the mental capacity to provide informed consent for participation within the study
* Patients who have had anterior lumbar spinal surgery at least 12 months ago and no longer than 5 years ago

Exclusion Criteria:

* Unable to understand written or verbal information regarding the study
* Multiple abdominal surgeries prior to spinal surgery
* Previous renal complication such as renal strictures or hydronephrosis/use of stents
* Pregnancy
* Structural anomalies
Noncontact Vital Sign Monitoring Using IR-UWB Radar

Background: Contact sensors can cause injuries and infections in newborn infants with fragile skin. The impulse radio ultra-wideband (IR-UWB) radar is recently demonstrated in adults as a contactless method to measure heart rate. The purpose of this study is to assess heart rate (HR) in neonates using IR-UWB radar and evaluate its accuracy, compared to the electrocardiogram (ECG) in the neonatal intensive care unit (NICU).

Methods: HR is recorded in newborn infants using both IR-UWB radar 35 cm away from the chest and ECG simultaneously in the NICU. The HR data during sleeping/calm state are automatically collected by a software algorithm. A total values averaged from a 30-second window every 10 s is used for the analysis. Data acquired on the same patient with standard electrocardiogram has been used for comparison.

Vital sign is recorded by the radar and bedside ECG simultaneously in supine position within an open-air crib.

The three electrodes of the ECG are attached at the standard positions and connected to the BSM-6501K patient monitor (Nihon Kohden, Tokyo, Japan), and vital signs are recorded and extracted.

The data from the radar is connected to a computer through a USB interface, and signal processing has been automatically performed by a software algorithm described by our previous study. A Fourier transform decomposes a signal with respect to time into a frequency component.

Vital sign is recorded continuously, and digital outputs are extracted from periods when no large noise or fluctuation occurs in both methods. While vital sign acquisition is significantly interfered with moving extensively, being in nursing care, repetitive myoclonus, hiccupping, flopping, or crying, the IR-UWB radar system stops the measurements and deletes the motion-contaminated observations automatically by itself. To investigate the artifact and interference by body movement during measurement, the level of movement is integrated based on the change of distance of the body from the radar. The radar transmits dozens of these signals (frames) to the computer every second, and the frame would not be changed if there was no movement within the range of the radar. However, if there is any movement, the difference of two frames (previous - current) is calculated.

Eligibility Criteria:
Inclusion Criteria:

* full-term neonates (\> 37 weeks of gestational age)

Exclusion Criteria:

* patients with congenital anomalies
Screening for Atrial Fibrillation in Patients With Cancer: A Pilot Randomized Controlled Clinical Trial

Patients with cancer have a higher incidence of AF but despite the higher incidence of AF in the cancer population, there are no randomized controlled trials (RCTs) for AF screening in this population. RCTs of AF screening in the general population have shown that screening can effectively detect AF earlier, and helps to identify candidates for appropriate anticoagulation that may lead to improvement in clinical outcomes.

The Investigators will conduct an open label, prospective, pilot RCT. After informed consent, patients will be randomized 1:1 into screening or usual care. Screening will be done at a single time point. Patients randomized to screening will undergo a 30-second ECG using the Kardia Mobile device (AliveCor Inc, Cupertino, CA) paired with an iPad (Apple, Cupertino, CA). Patients randomized to usual care will not receive a screening ECG. Primary outcome will be detection of newly diagnosed AF by screening vs usual care.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients age ≥65 with a current diagnosis or history of cancer.
2. Patients currently undergoing or history of chemotherapy, radiotherapy or cancer related surgeries will be included.
3. The age is restricted to ≥65 years because prevalence of AF is extremely low. .

Exclusion Criteria:

1. Known history of atrial fibrillation.
2. Non-English-speaking participants will not be enrolled
Uniting Couples in the Treatment of Binge-Eating Disorder

The purpose of this study is to test the feasibility, acceptability, and preliminary effectiveness of a novel couple-based intervention for binge-eating disorder (BED) relative to an established evidence-based individual treatment (cognitive-behavioral therapy-enhanced; CBT-E) in a community clinic setting.

Clinicians' options for BED treatment are inadequate. Treatments for BED have demonstrated efficacy in controlled settings with specialist therapists and expert supervision, but much less in known about the effectiveness of BED interventions and whether the transition of evidence-based treatments to the community results in poorer outcomes. UNITE activates a key resource by incorporating an important part of the patient's social environment (the partner) into treatment. The investigators hypothesize that UNITE will show preliminary evidence of being superior to CBT-E in achieving binge abstinence via engaging ED-related relationship targets, including improved (a) communication around the disorder, (b) disorder-specific interpersonal problem-solving/ behavioral change skills, and (c) partner-assisted emotion regulation. The investigators will assess targeted relationship domains with observational and speech prosody measures during clinic interactions and self-reports reflecting experiences outside the clinic. Because the couple is learning how to work together to address BED, the investigators hypothesize that maintenance of gains will show evidence consistent with superiority in UNITE.

Eligibility Criteria:
Inclusion Criteria:

* current Diagnostic and Statistic Manual (DSM-5) criteria for binge-eating disorder (patient only)
* at least 18 years of age
* English speaking and able to read
* in a committed relationship for at least 6 months regardless of sexual orientation
* live with partner (or are interact with each other daily)
* partner willingness to participate in treatment
* able to travel to Chapel Hill, North Carolina weekly for treatment

Exclusion Criteria:

* alcohol or drug dependence in the past year
* current anorexia nervosa
* current significant suicidal ideation with active suicidal intent
* severe depression that would seriously interfere with functional capacity
* developmental disability that would impair the ability to benefit from the intervention
* any psychosis, schizophrenia, or bipolar I disorder, unless stably remitted on maintenance therapy for at least 1 year
* moderate to high reported levels of physical violence from either partner
* unwillingness to forgo non-protocol concurrent couple therapy or individual therapy (patient only)
* previously participated in the UNITE pilot trial
The Effect of Soluble Fiber Dextrin on Subjective and Physiological Markers of Appetite

This study examines the effect of soluble fiber dextrin on food intake, appetite, and physiological markers of appetite. Adults aged 18-45 years with a BMI were recruited for this study. Participants were given two doses of SFD in the morning and appetite, food intake and physiological markers of appetite were measured over 10 years.

Overweight and obesity are leading health problems. The study investigates the effect of a food ingredient from two different sources at two different doses on food intake and appetite markers over a 10 hour period. All participants reported to the laboratory first thing in the morning and remained in the laboratory until after their evening meal. A fixed breakfast was served but the participants were free to eat as much as they liked at lunch and dinner. Blood was taken at regular intervals during the day and assayed for glucose and several hormones related to appetite. Subjective measures of appetite were also collected over the 10 hour test session.

Eligibility Criteria:
Inclusion Criteria:

BMI 19.9 - 29.9 Aged 18-45 Find the study foods to be palatable

Exclusion Criteria:

Weight change \> 3kg in the past three months Do not regularly consume snacks Presence or history of GI disorders Restrained eater Used medication that influences appetite
Double-blind Clinical Trials of Probiotic Products in Oral Health.

In order to evaluate the effects of supplementary probiotics and their metabolites on oral environment and oral microbiota, Taiwan FDA No. 88037803 will be used to evaluate the effects of oral probiotic candidate strains from previous research results and develop oral probiotic products.


Eligibility Criteria:
Inclusion Criteria:

* Adults between 20 to 40 years old.
* More than 10\^5 Streptococcus mutans (CFU/mL) of saliva.

Exclusion Criteria:

* Smoking.
* Subject has major illness.
Effectiveness of Binge Eating Disorder Treatments

This study will evaluate the long-term effectiveness of interpersonal psychotherapy, behavioral weight loss interventions, and guided self help treatments in treating binge eating disorder (BED).

BED is a serious condition that is associated with psychiatric comorbidity, psychosocial impairment, and obesity. Interpersonal psychotherapy (IPT), behavioral weight loss (BWL) interventions, and guided self help (GSH) treatments for BED have been evaluated, but the safest and most effective treatment has not yet been identified. This study will determine which of these three treatments is most effective in treating BED.

Participants are stratified by negative affect subtype and are randomly assigned for 6 months to one of three treatment groups: IPT, BWL, or GSH. IPT focuses on current interpersonal problems which are hypothesized to increase negative affect and lead to binge eating. BWL interventions involve the adoption of weight loss inducing behaviors. GSH is a shortened version of cognitive behavioral therapy that focuses directly on eating behavior. IPT and BWL patients have 20 treatment sessions; those receiving GSH have 10 sessions. Assessments are made pre-treatment, post-treatment, and at 6, 12, 18, and 24 months after treatment is complete.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for Binge Eating Disorder
* Body Mass Index (BMI) between 27 and 45

Exclusion criteria:

* Body Mass index \> 45
* Current psychosis
* Current bipolar disorder
* Alcohol or drug dependence within last 6-months
Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age

This is a study to evaluate the immunogenicity and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a pneumococcal conjugate vaccine in children as young as 15 months of age.

An open, controlled comparison of Havrix administered alone or with Prevnar. The three groups evaluated are: 1) Havrix alone, 2) Havrix plus Prevnar and 3) Prevnar followed by Havrix one month later.

Eligibility Criteria:
Inclusion Criteria:

* A male or female child 12 or 13 months of age at the time of entry into the Enrollment Phase,
* Free of obvious health problems,
* Subjects must have previously received three doses of Prevnar in his/her first year of life.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine within 42 days preceding the first dose of study vaccine, or planned use during the study period,
* Chronic administration of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period. (For corticosteroids, this will mean prednisone, or equivalent, less than 0.5 mg/kg/day. Inhaled, nasal and topical steroids are allowed.),
* Administration of the ACIP-recommended fourth dose of Prevnar prior to entering the Enrollment Phase of the study,
* Planned administration or administration of any vaccine not foreseen by the study protocol within the period of 42 days before and 30 days after each dose of study vaccine(s),
* Previous vaccination against hepatitis A,
* History of hepatitis A or known exposure to hepatitis A,
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection,
* A family history of congenital, hereditary or infectious immunodeficiency or parental risk factors for HIV infection,
* History of allergic disease/reactions or hypersensitivity likely to be exacerbated by any component of Havrix (e.g., neomycin, 2-phenoxyethanol) or Prevnar (e.g., diphtheria toxoid),
* Major congenital defects or serious chronic illness,
* History of any neurologic disorder (history of febrile seizures not associated with an underlying neurological disorder does not exclude the subject),
* Acute disease, defined as the presence of a moderate or severe illness with or without fever, at the time of vaccination,
* Administration of immunoglobulins and/or any blood products within three months prior to the first dose of study vaccine or planned administration at any time during the entire study period.
REView of ProcEdural FactoRs and Outcomes After Atrial Fibrillation Ablation With Active Esophageal COOLing: A Sub-Study of the REAL AF Registry

This is a multi-center sub-study examining the effectiveness of active esophageal cooling on subjects undergoing left atrial ablation for symptomatic Paroxysmal Atrial Fibrillation or Persistent Atrial Fibrillation.

Treatment of atrial fibrillation, using pulmonary vein isolation, involves some risks to collateral structure, including the esophagus. Active esophageal cooling has shown benefits in multiple studies when used in the treatment of Paroxysmal Atrial Fibrillation or Persistent Atrial Fibrillation during left atrial ablation. The largest randomized, controlled trial to date, the IMPACT study, found an 83% reduction in endoscopically identified esophageal lesions when using the active cooling, with a dedicated device, compared to standard esophageal monitoring, with no difference in Atrial Fibrillation recurrence rates at follow-up. Recent analyses have suggested additional effects from active esophageal cooling during pulmonary vein isolation, including reductions in procedure time, reductions in fluoroscopy usage, reductions in post-ablation discomfort, and improvements in long-term freedom from arrhythmia. Further investigation of these associations is important to better understand the magnitude of these findings in a variety of clinical settings.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic Paroxysmal Atrial Fibrillation (AF episode terminate spontaneously within 7 days) or Persistent Atrial Fibrillation (AF sustained beyond 7 days) who, in the opinion of the investigator, are scheduled for ablation for Atrial Fibrillation with active esophageal cooling.
* \>18 years of age
* Index or redo ablation procedure and enrolled in the REAL AF Registry
* Willing and able to provide informed consent and complete GERD questionnaire.

Exclusion Criteria:

* For the purpose of this sub-study, candidates will be excluded if they meet any of the following criteria:
* Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan.
* In the opinion of the investigator, any known contraindication to an ablation procedure.
* \<18 years of age