cyrilzakka/clinical-trials huggingface dataset:
Monocyte Soluble Activation Markers sCD14 and sCD163 in Children With Type 1 Diabetes Mellitus

The study aims to compare serum levels of sCD14 and sCD163 in children with type 1 Diabetes Mellitus with healthy controls, study the distribution of monocyte subsets in children with T1DM , correlate monocyte subsets and their soluble activation markers sCD14 and sCD163 with parameters reflecting islet β-cell insufficiency in children with T1DM.

Type 1 diabetes mellitus (T1DM) is T-cell mediated autoimmune disease in which the function of insulin-secreting pancreatic β-cells is impaired due to autoreactive immune cell-mediated destruction (insulitis). Although adaptive immunity has always been the focus for scientists in studying the pathogenesis of T1DM, yet, innate immunity also plays a critical role. Alterations in innate immune responses drive autoimmune pathogenesis, with involvement in the initial break in tolerance and the later failure of regulation. Several studies suggest that the development of T1DM is strongly associated with different immune cells, including monocytes. Specifically, an increase in the monocyte population has been shown to trigger β-cell destruction during insulitis. Intermediate monocytes may serve as M2 macrophage precursors with high anti-inflammatory properties, producing IL-10. However, other studies reported them to have an antigen-presenting function with a dendritic cell-like feature. Upon antigen stimulation, they became the main producers of inflammatory factors, like TNF-α which has been shown to correlate with the severity of T1DM. Activation of circulating monocytes to a pro-inflammatory state induces the shedding of membrane bound CD14 (mCD14) to soluble CD14. Compared to other acute phase proteins, sCD14 was found to be the most sensitive in T1DM. Soluble CD163 is present in blood serum as a result of shedding the CD163 membrane form of activated monocyte-macrophage-lineage cells in the course of inflammation. Plasma sCD163 is widely used as an immunomodulator with anti-inflammatory properties. It was found to be increased in T2DM.

Eligibility Criteria:
Inclusion Criteria:

* Children of any age and sex diagnosed with T1DM (according to WHO criteria) with a minimum duration of five years will be included.

Exclusion Criteria:

* Children with other with coexisting autoimmune, chronic, and acute inflammatory diseases.
Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma

Treatment on this study combines two drugs: Thalomid™ (thalidomide) and carboplatin. Thalidomide has been available for many years and has been used to treat many different illnesses. Carboplatin is an effective medicine in killing cancer cells. Thalidomide works by blocking angiogenesis (the process of new blood vessel formation). If a tumor does not have blood vessels providing oxygen and nutrients, it will not be able to grow. This research will look at how combining the effects of thalidomide (preventing tumor growth) with the tumor killing effect of carboplatin effects the long-term outlook for patients with these tumors.

This study will try to find out how well Thalomid™ and carboplatin combined with radiation therapy works in treating children newly diagnosed with brain stem glioma. This study will look at how well Thalomid ™ and carboplatin work in patients with recurrent brain stem glioma. This study will also look at any side effects of these treatments.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be \>/= 3 and \</= 21 years of age.
* Patients must have a newly diagnosed or progressive brain stem tumor.
* If biopsy has been performed, patients with both high and low grade astrocytomas are eligible.
* Non-histologically confirmed brain stem tumors are eligible. Neuroradiographic confirmation of brain stem glioma is mandatory for study entry.
* Cervicomedullary junction tumors are ineligible.
* Patients with a diagnosis of NF-1 are ineligible.
* Patients must be registered within 6 weeks from diagnosis or recurrence.
* Patients must have life expectancy \> 6 weeks.
* Patients must have adequate hematologic and renal function: ANC \>1,000/ul, platelets\>100,000/ul and creatinine normal for age: \</= 0.7 mg/dl (age 3-10yrs.), \</= 1.0 mg/dl (11-12yrs.). and \</= 1.2 (13-21yrs.).
* Written informed consent must be obtained according to institutional guidelines.
* Pregnant or nursing women are ineligible.
* Patients must be registered within 3 days prior to the start of protocol treatment. Patients must not start treatment until informed consent is given and the patient is registered. Willingness and ability to comply with the FDA-mandated S.T.E.P.S.® program.
Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer

This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT Chemotherapy Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN).

This study investigates treatment of durvalumab or placebo therapy combined with FLOT chemotherapy (flurouroacil + leucovorin + oxaliplatin + docetaxel) given before surgery (neoadjuvant) and durvalumab or placebo therapy combined with FLOT chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer, and also to better understand the studied disease and associated health problems.

Eligibility Criteria:
Key Inclusion Criteria:

* Patients with histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (Stage II or higher per AJCC 8th edition).
* Patients must undergo radical surgery.
* No prior anti-cancer therapy for the current malignancy.
* World Health Organization (WHO)/ECOG performance status of 0 or 1 at enrollment.
* Adequate organ and marrow function.
* Availability of tumor sample prior to study entry.
* Must have a life expectancy of at least 24 weeks.

Key Exclusion Criteria:

* Patients with peritoneal dissemination or distant metastasis.
* Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor.
* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
* Contra-indication to any of the study drugs.
* History of allogeneic organ transplantation.
Validation of Simplified Electrophysiological Examination in the Diagnosis of Critical Illness Myopathy or Neuropathy

Evaluate the accuracy, in the diagnosis of critical illness myopathy and / or neuropathy, of the simplified peroneal nerve test performed by a neurophysiopathology technician or by a neurophysiopathology doctor (as the gold standard) compared to the exam performed by an intensivist.


Eligibility Criteria:
Inclusion Criteria:

- adult patients admitted to Intensive care unit

Exclusion Criteria:

* patients in terminal conditions
* patients with peroneal nerve exam not feasible ( for example with presence of prostheses, wounds, plaster casts, edema of the limbs)
A Post Marketing Surveillance on Piqray in Korea

This is a prospective, multicenter, open-label, non-comparative, non-interventional, observational study to assess te safety and effectiveness of Piqray in the real-world setting

The observation duration will be up to 24 weeks after enrollment, which is sufficient to provide adequate information about the safety and effectiveness of Piqray. If the subject does not return for a follow-up visit or stops taking Piqray for any reason, all data collected until the date of the last contact of the subject will be used. Patients will be followed up (safety follow up) for 30 days afetr either 24 weeks-treatment or early withdrawal.

Eligibility Criteria:
Inclusion Criteria:

Subjects eligible for this study must meet all of the following criteria:

1. Postmenopausal women and men who have a confirmed diagnosis of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer.
2. Patients who have progressed on prior endocrine based therapy and are going to start Piqray treatment for the first time in accordance with the locally approved label.
3. Patients who are willing to provide written informed consent

Exclusion Criteria:

Subjects eligible for this study must not meet the following criteria:

1. Patients with contraindication according to prescribing information for Piqray in Korea.

   - Severe hypersensitivity to Piqray or to any of its components
2. Female subjects who are pregnant and nursing (lactating)
3. Patients who are sexually active but not willing to follow contraceptive precautions during taking Piqray.
4. Participants who receive or are going to receive any investigational medicine during surveillance period.
The Effect of Music Intervention on Anxiety, Fear, and Pain in Pediatric Patients Receiving Intrathecal Chemotherapy

Intrathecal chemotherapy is often used to prevent the spread of cancer to the central nervous system in pediatric patients and is one of the most invasive procedures. It is believed that the way it is administered and the complications experienced after treatment negatively affect the comfort of the pediatric patient, leading them to refuse the treatment.

Receiving sedation is one of the pharmacological procedures for intrathecal chemotherapy which creates a particularly difficult situation for the child. However, since pharmacological methods increase the cost and cause toxicity in children, in recent years, the symptoms that occur in cancer treatment have been tried to be controlled with non-pharmacological methods. Music intervention facilitates a sense of control in patients and provides mental distraction, emotional smoothness, and relaxation, which have been found to have pain relief effects.

Eligibility Criteria:
Inclusion Criteria:

* To be between 6-12 years old,
* Being treated in the Hematology and Oncology Clinic,
* About to receive intrathecal chemotherapy treatment,
* The child not having pain before intrathecal chemotherapy treatment

Exclusion criteria were,

* Refusing to participate in the study,
* Being under 6 years of age and over 10 years of age,
* The child having pain prior to intrathecal chemotherapy treatment,
* Having any physical or mental disability,
* Not being able to speak Turkish.
Rituximab in Combination With Outpatient Therapy for CD20+ Lymphoma

This is a Phase II pilot study evaluating the safety of a risk-adjusted outpatient-based approach to lymphoma salvage therapy with VGF (vinorelbine, gemcitabine and pegfilgrastim) and/or F-GIV (gemcitabine, Ifosfamide, vinorelbine and pegfilgrastim) in combination with Rituximab (R-VGF/R-F-GIV).

Recent epidemiologic surveys have demonstrated a dramatic increase in the incidence of non-Hodgkin's lymphoma (NHL). NHL is now one of the most rapidly increasing malignancies in the industrial world.

The purpose of this project is to evaluate the efficacy and safety of an outpatient treatment for relapsed or treatment resistant (refractory) CD20+ lymphoma. Two combinations of chemotherapy drugs will be tested depending on the patients prior therapy and response - rituximab, vinorelbine and gemcitabine (R-VGF) OR rituximab, vinorelbine, gemcitabine and ifosfamide (R-FGIV).

Previous experience, including a recently completed study using combinations of vinorelbine, gemcitabine and ifosfamide has demonstrated that such an outpatient approach is safe and of similar efficacy to presently available alternative inpatient chemotherapy approaches. This study is expanding on the findings from the previous study by adding rituximab.

Rituximab is being increasingly and successfully used in the therapy of CD20+ NHL. It is a specific protein (antibody) that is directed against the surface protein (CD20 antigen) found on CD20+ lymphoma cells and can therefore lead to the destruction of these cells. Rituximab also has a highly favourable toxicity profile enabling outpatient treatment.

All of these factors provide a strong rationale for the combination of rituximab and the novel outpatient-based salvage approaches VGF and F-GIV that we have recently evaluated. This pilot study of 12 patients will test the feasibility of this combination approach in patients with relapsed/refractory CD20+ NHL.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Relapsed or primary refractory CD20+ NHL
* ECOG 0 - 2
* Written informed consent

Exclusion Criteria:

* Intention to proceed with any form of transplant therapy following fewer than 2 cycles of protocol salvage therapy.
* Bilirubin \> 50µmol/litre unless secondary to lymphoma
* Creatinine \> 2 x upper limit of normal unless secondary to lymphoma
* Absolute neutrophil count \<0.5 x 109/litre and / or platelets \< 50 x 109/litre unless secondary to lymphoma
* Relapse within 6 months of a prior transplant procedure (autologous or allogeneic).
* Known sensitivity to E coli derived preparations
Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement

Ancillary Aim #1 We will evaluate intervention effects by comparing binary outcomes for screening (yes/no) in the primary SOS study. In this aim, we propose to calculate actual screening rates by use of time-to-event analyses (also known as survival analysis). The outcome variable of interest is the first time since randomization to have CRCS, either based on FOBT, FS, or CS. Knowing screening rates will not only enable us to make comparisons between groups, but also over time.

Ancillary Aims #2 and #3 We will recruit additional participants for two ancillary study aims. First, we will enroll patients age 50-74 years using the same criteria as for the primary SOS study, which includes neither history of colorectal cancer nor evidence of life-limiting disease. Participants who return the questionnaire, consent and considered eligible will be randomized to receive one of three different at-home fecal test kits. The kits will be returned to the GH centralized laboratory, and participants will be informed about lab results using standard GH pathways. Participants who have a test-positive will receive a series of two follow-up surveys (first at 1-2 weeks post result and second at 4-months post result). A comparison group of test-negative results will be matched based on selected criteria, and this group will also receive the follow-up surveys. Participants at both time intervals who do not return the survey via mail will be called and if available, administered the questionnaire via phone.


Eligibility Criteria:
Inclusion Criteria:

* Not up to date on CRCS
* Continuously enrolled in GHC for 24 months
* Expected to continue to be enrolled at GHC for 24 months

Exclusion Criteria:

* Known high risk for CRC
* History of CRC
* History of inflammatory bowel disease
* Current anticoagulation therapy
* Organ failure
* Serious illness
* Debilitating disease
* Dementia
* Nursing home resident.
Assisting in Decisions in Emergency Departments: (ED-AID) Study

This study will test a patient decision aid about safe firearm storage during suicidal crisis. The investigators hypothesize that participants with higher quality decisions after the decision aid will be more likely to change their firearm storage to reduce access during the time of crisis.

Limiting access to a firearms during suicidal crisis can save lives. This study will test a patient decision aid about safe firearm storage during crisis. The investigators will enroll 60 adult emergency department patients being evaluated for suicidal risk and have at least one firearm at home. If available, the investigators will also enroll a family member or friend. Participants will randomly receive one of two things: the decision aid or general suicide prevention information. A week later, the investigators will call participants to see how both groups choose to store their firearms. This trial tests the acceptability of the decision aid, effects on decision making, effect on home storage, effect on suicide outcomes, and feasibility of a larger trial. The investigators hypothesize that participants with higher quality decisions after the decision aid will be more likely to change their firearm storage to reduce access during the time of crisis; should the pilot demonstrate feasibility, in a subsequent larger trial this hypothesis would be tested directly.

Eligibility Criteria:
Inclusion Criteria:

* Being evaluated in the emergency department for suicidal ideation/suicide attempt
* Deemed medically stable by ED physician
* Age greater than or equal to 18 years old
* Able and willing to have telephone follow up at 1 week
* Report at least one firearm in the home

Exclusion Criteria:

* Unable to participate medically or cognitively (e.g. sustained altered level of consciousness, hostility, psychosis, sexual assault victim, severe vomiting or pain)
* Currently in legal custody
* Live in group home or other supervised custody
* Already enrolled
Randomized Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer

The purpose of this study is to compare the efficacy between gemcitabine/cisplatin and S-1/cisplatin in the first-line treatment in advanced biliary tract cancer.

Standard chemotherapy regimen for biliary tract cancer(BTC) has not been established due to the difficulty associated with performing clinical trials in this field.

Gemcitabine or fluoropyrimidines, including 5-fluorouracil and S-1, are routinely used for BTC chemotherapy. The European Society for Medical Oncology (ESMO) and the National Comprehensive Cancer Network guidelines published in 2009 recommend either gemcitabine-based or fluoropyrimidine-based chemotherapy or clinical trials for first-line treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age : older than 20
* Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
* Histologically confirmed adenocarcinoma of the biliary tract
* Metastatic or unresectable biliary cancer
* No prior chemotherapy for biliary cancer
* A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT)
* Adequate bone marrow, liver, renal function

Exclusion Criteria:

* A patient with no measurable disease
* A patient who received previous palliative chemotherapy for biliary cancer
* A patient who received adjuvant chemotherapy for biliary cancer within 1year
* A patient with previous active or passive immunotherapy.
* A pregnant or lactating patient
Assessment of the Effects of Access Count in Percutaneous Nephrolithotomy on Renal Functions by Technetium-99M-Dimercaptosuccinic Acid Scintigraphy

In this study 37 patients who had undergone percutaneous nephrolithotomy were included. Preoperative DMSA scans were performed a day before the surgery, whereas postoperative scans were randomized by evaluating them before (n=25) and after (n=12) the 6th postoperative month. A DMSA scan was read by using a technique that divides both kidneys into three paired poles. In this way functional changes were investigated in the renal units. Twenty six of 37 cases underwent percutaneous nephrolithotomy with a single access site and 11 with multiple access sites. When each of the poles of a kidney was admitted as a surgical unit separately, there were 51 units.

Total 37 patients who had undergone PCNL were included between June 2007-June 2009. All patients were evaluated routinely with physical examination, complete blood count (CBC), blood urine nitrogen (BUN), creatinine levels, and urinalysis. None of the patients had experienced pyelonephritis, and none had a solitary kidney, renal ectopy or history of any other urinary abnormality. At least one of the following techniques; namely computed tomography (CT), intravenous urography or ultrasonography, was preferred routinely before surgery in order to visualize the urinary system. Unilateral PCNL was performed in all patients. Postoperative CBC and BUN creatine levels were repeated.

Preoperative DMSA scans were performed a day before the surgery, whereas postoperative scans were randomized to indicate early and late term. The aim of randomization was to determine an optimal time for assessing patients. A DMSA scan was read by using a technique that divides both kidneys into three paired poles. In addition the uptake of all opposite poles was measured together and calculated as a percentage value separately (Figure-1), e.g., the two upper poles' uptake was measured together as if they were renal units and each poles' own portion in this total uptake was declared separately as a percentage. How the differential functions were changed between the sides undergoing PCNL and the opposite sides, as well the changes before and 6 months after surgery are manifested by using these parameters.

Twenty six of 37 cases underwent PCNL with a single access site (70.3%) and 11 separately with multiple accesses (29.7%). When each of the poles of a kidney was considered as a surgical unit, there were 51 units. In this manner the functional change of a unit would show the surgical trauma inflicted on the poles by PCNL access.

Eligibility Criteria:
Inclusion Criteria:

- Patients with renal stones which was bigger than 2cm.

Exclusion Criteria:

* Patients with acute urinary tract infection,
* Patients with bleeding disorder,
* Patients with chronic renal failure,
* Patients with solitary kidney, renal ectopy or history of any other urinary abnormality.
Administration of a Bitter-Tasting Medication: Comparison Between the Rx Medibottle and the Oral Syringe

Hypothesis: The Rx medibottle is more effective than the oral syringe when giving infants less than 2 years of age a bitter-tasting medication (prednisolone syrup).

Summary: Infants who were admitted to the pediatric floor with a respiratory illness at the Bronx-Lebanon Hospital were offered the chance to take part in the study. If these children needed prednisolone syrup for their treatment, were less than 2 years old and were bottle-fed, and were in stable condition, they qualified. They were randomly assigned (just by chance), into a control arm, where they received medication using the oral syringe, or an intervention arm, where they were given medication using the Rx medibottle. How well the infant accepted the bitter-tasting medication was compared between the two arms using an infant medication acceptance scale. The scale was administered and a score generated by two raters: the nurse who administered the medication, and a child life therapist who witnessed the administration. The time needed to give the medication, the drug delivery device's ability to administer the entire dose of medication and the mother's satisfaction with the method used were also compared between the two arms.

The ability to deliver drugs to infants and children safely and accurately has long been of concern to pediatricians and caregivers. Calibrated oral syringes are accurate in measuring and delivering the required dose, have minimal potential for spillage and are considered the standard drug delivery system for this population. However, infant acceptance of the syringe may not always be favorable. The objective of this study was to compare the Rx medibottle to the oral syringe when used to administer liquid medication to infants. It is a prospective, controlled trial that enrolled infants \<2 years of age admitted to a community hospital in the Bronx, who were prescribed a daily dose of 2 mg/kg of prednisolone syrup (15 mg/5 ml) for a respiratory illness. Participants were randomly assigned to receive one dose of prednisolone syrup using the Rx medibottle (intervention arm) or the oral syringe (control arm). The infant medication acceptance scale (MAS) used to evaluate acceptance by the infants was developed and validated by Donna Kraus, Leslie Stohlmeyer and Patricia Hannon and published in the American Journal of Health-System Pharmacy (1999;16:1094-1101).

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the pediatric inpatient unit
* Stable condition
* Bottle fed
* Less than 2 years
* Receiving prednisolone syrup (15 mg/5 ml)

Exclusion Criteria:

* Breast fed
* Greater than 2 years