cyrilzakka/clinical-trials huggingface dataset:
Allogenic Stem Cell Transplantation in Patients With High Risk CD33+ AML/MDS/JMML

The addition of gemtuzumab ozogamicin (GO) in combination with Busulfan/Cyclophosphamide followed by AlloSCT in patients with high risk CD33+ AML/JMML/MDS will be safe and well tolerated.

This study will attempt to determine the maximum tolerated dose of the immune therapy (gemtuzumab) when given in combination with the myeloablative (high dose) drugs used in this study for allogeneic stem cell transplant. (Part A)

Gemtuzumab Ozogamicin (CMA-676) is a chemotherapeutic agent consisting of recombinant humanized anti-CD33 antibody conjugated with calicheamicin, a highly potent cytotoxic antitumor antibiotic. The antibody portion of Gemtuzumab binds specifically to the CD33 antigen, a sialic acid-dependent adhesion protein expressed on the surface of leukemia blasts, normal and leukemic myeloid colony-forming cells, including leukemic clonogenic precursors, but excluding pluripotent hematopoietic stem cells and nonhematopoietic cells. This results in formation of the complex that is internalized, upon which calicheamicin derivative is released with in the lysosomes of the myeloid cell. The free calicheamicin derivative then binds to the DNA, resulting in DNA double strand breaks and consequential cell death.

Eligibility Criteria:
Eligibility

Inclusion Criteria:

Disease Status

* AML Induction Failure
* AML in 1st, 2nd, or 3rd Relapse (\>10% bone marrow blasts)
* AML greater than or equal to 3rd CR
* MDS with \>6% bone marrow blasts at diagnosis
* Secondary MDS with less than or equal to 5% bone marrow myeloblasts at diagnosis
* JMML with \>6% bone marrow myeloblasts at diagnosis

Disease Immunophenotype Patients (AML only) receiving gemtuzumab ozogamicin must express minimum of \>10% or =10% CD33 positivity. Patients with \<10% CD33 positivity will not receive gemtuzumab ozogamicin.

Organ Function

Patients must have adequate organ function as defined below:

* Adequate renal function defined as:
* Serum creatinine \<1.5 x normal, or
* Creatinine clearance or radioisotope GFR 40 ml/min/m2 or \>60 ml/min/1.73 m2 or an equivalent GFR as determined by the institutional normal range
* Adequate liver function defined as:
* Total bilirubin 1.5 x normal, or SGOT (AST) or SGPT (ALT) \<2.0 x normal or =2.0 x normal
* Adequate cardiac function defined as:
* Shortening fraction of \>27% by echocardiogram, or
* Ejection fraction of \>47% by radionuclide angiogram or echocardiogram
* Adequate pulmonary function defined as:
* DLCO \>55% or =55% by PFT
* For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \>94% on room air

Exclusion Criteria:

* Patients with active CNS AML/JMML/MDS disease at time of conditioning therapy
* Female patients who are pregnant (positive HCG)
* Karnofsky \<50% or Lansky \<50% if 10 years or less
* Age \>65 years
* Has received gemtuzumab in the previous 30 days or has not recovered from prior gemtuzumab therapy.
Effect of Fruit and Vegetable Intake on Markers of Fruit and Vegetable Consumption

This study will examine what contribution of 'markers' of fruit and vegetable (FV) intake in blood and urine is most closely related to FV intake. 30 healthy volunteers will be fed either 2, 5 or 8 portions of FV per day for 4 weeks (ten participants per group, randomly assigned). Volunteers will have all their food provided during the study, and will consume two meals each weekday at the University. Volunteers will complete diet and lifestyle questionnaires at the start and end of the study and will have blood and urine samples collected at 0, 2 and 4 weeks.

Single biomarkers of FV consumption, such as Vitamin C and certain carotenoids and flavonoids, have been proposed, but associations between these compounds and FV intake are relatively weak. The investigators propose that, given the complexity of FV, production of an algorithm based on a wide variety of bioactive compounds found in FV might better predict FV consumption. A controlled feeding study (30 volunteers randomised to 2, 5 or 8 portions of FV day for 4 weeks) will allow development of such an algorithm. Volunteers will be recruited by advertisement from QUB and the general public, and will have all their food provided for the 4 week period (two meals per day during the week to be consumed under supervision at the University).

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years
* Usual consumption of fruit and vegetables \<= 2 portions/day

Exclusion Criteria:

* Use of any high dose vitamin, mineral or dietary supplements
* Current smoker
* BMI \> 35 kg/m2
* Inability to provide informed consent
* Excessive alcohol consumption (\>28 Units/week men or \>21 Units/week women)
* Food sensitivities or allergies that would interfere with a tolerance of a fruit and vegetable rich diet
* Medical conditions or dietary restrictions that would substantially limit inability to complete the study requirements
Mobilising Lower Limb Fluid for Hemodynamic Stability in Haemodialysis

Cardiovascular disease is the leading cause of death of dialysis patients and poor fluid management is associated with the increased risk. One of the principal limitations in avoiding chronic fluid overload in this patient group is the refilling rate the rate at which fluid is transferred from tissues into the vascular system. If this rate cannot match the prescribed rate of fluid removal during dialysis the patient will end up with chronic fluid overload.

Two proposed methods of increasing the rate of refilling are intermittent pneumatic compression (IPC) devices, which increase the pressure of the fluid in tissue, and neuromuscular electrical stimulation (NMES) which activates the muscle pump and lymphatic drainage.

This investigation will trial the use of these two methods in patients suspected of having inadequate refilling rates. Outcome measures will be based on fluid status, presence of oedema and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Presence of lower limb oedema as defined by pitting
* Average post dialysis fluid overload in relation to target weight greater than 0.5 litres
* Greater than one dialysis session that included an intradialytic hypotensive episode in the previous month, defined by saline influsion or nursing intervention

Exclusion Criteria:

* Less than 18 years of age
* Less than 3 months dialysis vintage
* Presence of metal implants, amputations or the inability to be weighed
Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis

Motor learning can induce significant changes in the human brain through neural plasticity processes, which play a crucial role in the brain functional reorganization in response to external stimuli and/or to pathological conditions. For example, people with multiple sclerosis present motor deficits often associated with cerebral activity alteration. However, whether these brain activation changes contribute to or protect against motor performance deficits still needs to be determined.

Moreover, rehabilitation protocols could be designed to obtain efficient brain adaptation to preserve patients' outcome, but consistent data on the real efficacy of rehabilitative procedures are lacking, in particular concerning the rehabilitation effect on brain networks.

Therefore, this project focuses on the degree to which imaging measures of functional brain activity can give new hints on the effects of motor rehabilitative protocols in multiple sclerosis patients' performance. Particularly, the investigator's aim is to investigate the effects of upper limb rehabilitation, focused on hand motor function, and the correlation between motor performance and functional magnetic resonance data.


Eligibility Criteria:
Inclusion Criteria:

* Multiple sclerosis diagnosis according to McDonald criteria
* right handedness as assessed by the Edinburgh Handedness Inventory
* absence of relapses in the last three months
* mild or moderate sensorimotor impairment in one or both upper limbs as evaluated by means of the Medical Research Council scale (grade 3-4)

Exclusion Criteria:

* steroid-use or a worsening of the Expanded Disability Status Scale (EDSS) score in the last three months
* psychiatric disorders
* severe cognitive impairment
* magnetic resonance imaging contraindications
Operation Korsband

This study aims to investigate if a detailed and comprehensive survey can identify, explain and prevent the risk factors for ACL injury.

A a new questionnaire has been developed with questions to young athletes who have suffered an anterior cruciate ligament injury. The questionnaire is more detailed and provide more information about how the anterior cruciate ligament injury occurred compared with the questionnaires currently available in the literature. This careful documentation will provide new knowledge and might be used to identify, explain and prevent risk factors that cause young athletes to suffer an anterior cruciate ligament injury.

Participants will be prospectively recruited at their first physiotherapist clinical session. On this occasion, participants will be asked to fill in a questionnaire regarding injury situation, game or training, sex, age, sport affiliation, level of sport, other aspects of sport such as participation in several teams and junior versus senior games/training. In addition, questions regarding previous injury will also be documented.

Eligibility Criteria:
Inclusion Criteria:

* Athlete
* Defined ACL injury

Exclusion Criteria:

* Non athletes
* Younger than 12 years
Vitamin D Levels in Women With Polycystic Ovary Syndrome

Polycystic ovary syndrome is the commonest endocrinopathy among women of reproductive age. Its worldwide prevalence has been estimated between5-10%.

Vitamin D, a fat-soluble vitamin, can be produced in two ways: by intestinal absorption and endogenous synthesis from a precursor of 17-hydroxyl cholesterol on the skin with sufficient exposure to ultraviolet sunlight.

The aim of this work is assessment of the level of vitamin D in female have polycystic ovary syndrome \& healthy female.and also make diagnostic criteria for patient who is in need for supplementations with vitamin D.

Eligibility Criteria:
Inclusion criteria:

* Hyperandrogenism
* Polycystic ovary syndrome

Exclusion Criteria:

* Thyroid disease
* Parathyroid disease
* Diabetes Mellitus
* Cushing syndrome
* Congenital adrenal hyperplasia
* Hyperprolactinemia
* Renal, liver or chronic disease
Just-In-Time Adaptive Interventions for Diabetic Patients

The addition of proactive nurse consultations was useful to older adults with diabetes mellitus in facilitating their chronic disease self-management. However, the service is time and resource-intensive. With the support of advanced technology, mhealth App seems to be a convenient way to support patients in managing diabetes.

This study examines the effectiveness of mhealth App plus nurse consultations in promoting self-management behaviours for diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* With a confirmed DM diagnosis for one year or more than one year
* Using governmental mhealth App
* Living in an area with Internet coverage

Exclusion Criteria:

* Already engaged in other mHealth programmes
* Physical and cognitive limitations
Regulation of Immunological Cytokines by Qiliqiangxin Capsule in Dilated Cardiomyopathy Patients

Purpose :Research into the impact of Qiliqiangxin capsule on IFN-γ，IL-4，NT-proBNP in dilated cardiomyopathy patients with heart failure.

Methods :Data were collected from the patients with idiopathic dilated cardiomyopathy ( cardiac function NYHA Ⅱ-Ⅳ) in the first affiliated hospital of Harbin Medical University from May 2012 to April 2014. These 30 cases were treated under the recommendations of normal diagnosis and treatment in cardiomyopathy. This experiment was randomized double-blinded，the experimental interferences were avoided and patients were divided into the experimental group and the placebo group. The patients in experimental group received the relevant tests and inspections before the beginning of experiment，signed the informed consent. Then the investigators get the venous blood centrifugalization and cryopreservation. The patients take the medicine qiliqiangxin three times per day，four tablets at a time. Afrer a month，the investigators evaluated the symptoms，the function of heart，blood pressure，heart rate and keep blood specimens. Three and six month later，electrocardiogram and echocardiography were taken and the determination of the NT - proBNP was done. The placebo group was followed up in the same way.


Eligibility Criteria:
Inclusion Criteria:

* Congetive heart failure

Exclusion Criteria:

* Valvular heart diseases
Optimal Dietary Treatment of Obese Adults

Recent decades have shown an alarming increase in obesity. Obesity is associated with high costs for both the individual and for society. It is therefore important to prevent and treat obesity. The investigators believe that if you add a self-help weightloss book and teach cooking skills to a standard dietary treatment, then it will result in greater weight loss than with dietary treatment alone. However, this has not yet been studied. Since it will require more resources, it is important to investigate whether it also works better before changing the current treatment.

Hypothesis: Conventional dietary treatment supplemented with a self-help weightloss book and cooking classes are more effective than dietary treatment alone in changes in body weight and body composition in obese persons over a period of 12 months. There is no difference if the intervention are based on the national dietary guidelines or a relative low-gi and high-protein diet.

Secondary to investigate the impact the interventions have; on diet quality and quantity, on markers of metabolic syndrome and on how many subjects complete the study.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 25
* Waist: female ≥ 88 cm; male ≥ 102 cm)
* Stable weight for the past three month (+- 5 kilogram)
* Motivated to make changes in their dietary habits

Exclusion Criteria:

* Waist \> 150 cm
* Significant cardiovascular, renal or endocrine disease
* Psychiatric history
* Treatment with steroids
* Alcohol- or drug-addiction
* Pregnancy or lactation
* Obesity surgery
Efficacy of Oral vs. Intravenous Acetaminophen

The comparative efficacy of intravenous (IV) to oral (PO-'per os') acetaminophen in the management of postoperative pain is understudied and largely unknown. In this observer blinded randomized clinical trial, investigators aim to determine the comparative efficacy of PO (preoperative) vs. IV (intraoperative) acetaminophen in a sinus surgery population.

The comparative efficacy of intravenous (IV) to oral (PO-'per os') acetaminophen is understudied and largely unknown. Intravenous acetaminophen has been available since 2010 (http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022450lbl.pdf) and has proven superiority over placebo in human clinical trials. It is clearly advantageous in patients who cannot take oral medications. Similarly, oral acetaminophen has proven efficacy in the management of postoperative pain.

However, in patients who can receive either formulation the incremental cost of the IV formulation, both to the Health System and patient, is substantial. This incremental cost would be justifiable if there were clear efficacy or safety data to support the preferential use of IV over PO acetaminophen.

However, there is no evidence of superior safety and there are only two studies to our knowledge investigating the question of comparative efficacy. Fenlon et al. randomized 130 patients undergoing 3rd molar (i.e., wisdom tooth) removal to IV vs. PO acetaminophen and found that PO acetaminophen was non-inferior to IV acetaminophen. The primary endpoint was postoperative pain score 1h after surgery. No safety concerns were identified in either group. Pettersson et al. randomized cardiac surgery patients to IV or PO acetaminophen, starting immediately postoperatively through the following morning, and found a significant opioid sparing effect of IV acetaminophen but no difference in pain scores or nausea.

IV acetaminophen avoids first-pass hepatic metabolism and therefore generates higher serum and cerebrospinal fluid (CSF)/brain levels than does PO acetaminophen (http://ofirmev.com/Pharmacokinetics/). Based on the pharmacokinetic data, one can hypothesize that IV acetaminophen would be superior to PO acetaminophen at time points where serum and/or cerebrospinal fluid drug levels are higher.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 years or older
* Undergoing elective sinus surgery at Zale Lipshy Hospital

Exclusion Criteria:

* Inability of the patient to follow directions or comprehend either English or Spanish language.

  * Disorders of the liver which would make acetaminophen contraindicated (such as hepatitis, liver failure, prior liver transplant, etc).
  * Patients with chronic pain manifest by a baseline pain score \> 4/10
  * Chronic opioid use (\>2 weeks continuously), or illicit drug abuse
  * Body weight \< 50 kg.
  * Patients with contraindications to any of the study drugs (such as Malignant Hyperthermia susceptible, celecoxib or sulfa allergy, etc.).
  * Patients who have taken analgesic medications on the morning of surgery (prior to arrival).
  * Allergy to acetaminophen
Contact Tightness of Zirconomer Versus Nanohybrid Composite in Occlusoproximal Cavities in Molars

To achieve an optimal contact area is essential to avoid tooth migration, food impaction, and the occurrence of secondary caries. However, proximal restorations constitute challenge for the professional and tight contact points are difficult to obtain depending not only on tools used, but also on type of restorative material. Current tooth-colored restorative materials are not condensable and there is shrinkage with setting. The aim of this study is to compare the proximal contact tightness of zirconia reinforced glass ionomer versus conventional nanohybrid resin composite when used in class II cavities.


Eligibility Criteria:
Eligibility Criteria of participants:

Inclusion Criteria of participants:

* Patients with occlusoproximal caries in molars classified as ICDAS III or IV.
* 19-35 years.
* Males or Females.
* Co-operative patients approving to participate in the trial.

Exclusion criteria of participants:

* Pregnancy.
* Disabilities.
* Systemic disease or severe medical complications.
* Allergic history concerning methacrylate.
* Rampant caries.
* Heavy smoking.
* Xerostomia.
* Lack of compliance.
* Evidence of severe bruxism, clenching, or temporomandibular joint disorders.

  b- Eligibility Criteria of teeth:

Inclusion Criteria of teeth:

* Occlusoproximal caries in molars classified as ICDAS III or IV.
* Vital upper or lower posterior teeth with no signs of irreversible pulpitis.
* Intact contact with opposing teeth.
* Teeth with no previous restorations in other surfaces.

Exclusion criteria of the teeth:

* Extensive carious lesions
* Periapical pathology or signs of pulpal pathology.
* Tooth hypersensitivity.
* Possible prosthodontic restoration of teeth.
* Heavy occlusion and occlusal contacts or history of bruxism.
* Sever periodontal affection.
Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section

The aim of this single centre study is to measure maternal CD4+ t-cells in HiV exposed Newborns after spontaneous birth in comparison to cesarean section.

This may have an influence on the risk of vertical HiV transmission.

At birth maternal CD4+ t-cells from umbilical cord blood and placenta blood are measured by microchimerism-analysis.

After 6 weeks the maternal CD4+ t-cells are measured in the blood of the babies blood.

Additionally we look for HiV in maternal CD4+ t-cells.

Eligibility Criteria:
Inclusion Criteria:

• HiV exposed Newborns with normal risk of HiV transmission.

Exclusion Criteria:

* HiV exposed Newborns wiht elevated or high risk of HiV transmission.
* HiV exposed Newborns of mothers not full of age.
* missing informed consent of at least the mother
* Outborns
* Asphyxia
* Major congenital defects
* Chromosomal anomalies
Angiopoietin and Adverse Outcomes in Cardiac Surgery

Cardiac surgery and cardiopulmonary bypass can lead to systemic organ failure trough excess inflammation and endothelial injury. The angiopoietin family represented by angiopoietin 1 and 2 can reflect endothelial injury by a decrease in angiopoietin 1 and an increase in angiopoietin 2. The investigators hypothesized that angiopoietin dysregulation could reflect organ failure related to cardiac surgery.

The purpose of this project is to assess the association between angiopoietin dysregulation and adverse outcomes on cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* adult patient scheduled for cardiac surgery under cardiopulmonary bypass

Exclusion Criteria:

* patient less than 18 years old,
* redo surgery,
* urgent surgery,
* endocarditis,
* aortic root repair surgery
* aortic dissection
* heart beating surgery,
* heart transplantation
Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children

The goal of the study is to evaluate the application of Besivance™ (besifloxacin ophthalmic suspension, 0.6%) to treat congenital nasolacrimal duct obstruction in children. The hypothesis of the study is that Besivance™ is as safe and effective as the current standard of care for the treatment of nasolacrimal duct obstruction in children.

The primary objective of this study is to evaluate the safety and efficacy of Besivance™ as an antibiotic treatment for congenital nasolacrimal duct obstruction with infection in children. The primary outcome measure is the change from baseline on the physician rated scale of Nasolacrimal Duct Obstruction (NLDO)with infection to follow-up visit #2 (Week 8) or at the time of treatment failure, if earlier.

Eligibility Criteria:
Inclusion Criteria:

* Persons who have been diagnosed with congenital Nasolacrimal Duct Obstruction (NLDO) with infection by the Principal Investigator
* Both males and females
* Persons who are age of 1 to 12 months at time of diagnosis (time of diagnosis is defined as when the Principal Investigator makes clinical diagnosis.)

Exclusion Criteria:

* Persons who have received any antibiotic treatment for NLDO with infection for more than 2 week in the past 4 weeks.
* Persons who are currently receiving systemic antibiotic treatment that cannot be discontinued.
* Persons with any other ocular anomalies that could potentially interfere with interpretation of study results.
* Persons who have had any prior nasolacrimal duct system procedures such as stenting or probing.
* Persons who have previously participated in any clinical trial(s) of Besivance™
* Persons who have participated in any other clinical trial(s) of any investigational agent(s) within 30 days prior to the Baseline visit
* Persons who have any chronic diseases that might interfere with study participation
Utilizing Qualitative and Quantitative Methods to Understand a New Model of Type 1 and 2 Systemic Lupus Erythematosus (SLE)

The purpose of this study is to pilot test SLE@Duke, a set of tools to implement the Type 1 \& 2 SLE Model in a clinical setting, as well as to gain an in-depth understanding of providers experiences using the intervention during clinic visits with patients with systemic lupus erythematosus.

This record represents Aim 3 of this study.


Eligibility Criteria:
Inclusion Criteria:

* All providers in Duke Rheumatology who practice outside of the Duke Lupus Clinic are eligible.
* Patients are eligible to participate if they have an established diagnosis of SLE and are followed in Duke Rheumatology.
* All patients with a SLE diagnosis will be included in the analysis. SLE diagnosis will be based on an ICD-10 code for SLE (M32.1\*, M32.8, M32.9) in the EMR.

Exclusion Criteria:

* New patients will be excluded