cyrilzakka/clinical-trials huggingface dataset:
NYULMC CareSmarts Pilot

CareSmarts is a theory-driven behavioral intervention designed to improve self-care among patients with Type 2 diabetes (T2D) with poor glycemic control (HbA1c\>8%), through multiple mediators, including cuing, education, self-efficacy, social support, and health beliefs. Individuals will be randomly assigned with equal allocation to either the CareSmarts intervention or to usual care for 6 months.

CareSmarts is a mobile diabetes program that provides self-management support and team-based care management for people with diabetes through automated SMS messages. The program is a theory-driven behavioral intervention designed to improve self-care through multiple mediators, including cuing, education, self-efficacy, social support, and health beliefs. Participants in the program receive educational and motivational text messages about diabetes self-care, some prompts to engage in a particular action (for example, "Time to check your blood sugar"), and some self-assessment questions (such as, "Do you need refills of any of your medications?") to which the patient responds by texting. Participants' responses to self-assessment questions are used to facilitate remote monitoring and care management by the health care team. A response that is outside established parameters triggers an alert. Using protocols, nurses respond to each alert by the next business day.

Eligibility Criteria:
Inclusion Criteria:

* have a DRG Code of T2D, and be prescribed at least one oral T2D drug and/or insulin.
* must own an SMS capable mobile device and be willing to send and receive SMS messages regarding T2D self-management.
* The participant's physician of record will have verified that his/her patient can safely participant in an intervention study that targets an HbA1c \<7%.

Exclusion Criteria:

* unable or unwilling to provide informed consent
* unable to participate meaningfully in an intervention that involves use of SMS messages (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking)
* unwilling to accept randomization assignment
* pregnant, plans to become pregnant in the next 6 months, or who become pregnant during the study
* gestational diabetes
* breastfeedling
* individuals who are institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over self-management)
Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure

To investigate the incidence of detected hypothyroidism after iodinated contrast exposure in pediatric patients from birth to 3 years of age (inclusive) in a routine clinical practice setting.


Eligibility Criteria:
Inclusion Criteria:

- All children age 0-3 years (inclusive) who are identified of having undergone a radiological examination with intravascular use of an iodinated contrast agent.(e.g.

contrast enhanced CT, cardioangiography)

Exclusion Criteria:

* Congenital Hypothyroidism or other forms of preexisting hypothyroidism
* Preexisting thyroid hormone replacement therapy less than three months of observation before the radiological examination (if greater than three months old)
* Less than two weeks follow-up available after the contrast exposure.
Product Validation Study of RightSpot Infant pH Indicator for Rapid Bedside Verification of Proper Nasogastric (NG) Tube Placement in Newborn Intensive Care (NICU) Patients

Objectives:

1. To validate the accuracy of pH measurements of gastric fluid by comparing the readings from the RightSpot Infant pH Indicator to a standard clinically approved pH monitor
2. To determine what percentage of time the RightSpot Infant pH Indicator could have been used to determine the proper placement of the NG tube prior to feedings
3. To establish normative pH values for neonates

RightBio Metrics has developed an indicator that rapidly checks gastric pH by aspirating gastric contents into the indicator through a nasogastric (NG) or orogastric (OG), causing a color change on the indicator. The color change represents various pH levels. Most Newborn Intensive Care Units require that NG/OG placement be confirmed after initial insertion and prior to any use. The purpose of this study is to validate the accuracy of pH measurement of gastric fluid by comparing the reading from the RightSpot Infant pH Indicator to a standard clinically approved pH monitor, and to determine what percentage of time the RightSpot Infant pH Indicator could have been used to determine the proper placement of the NG/OG tube prior to use. The gastric pH measurements will be analyzed to determine the normative pH values for neonates.

Eligibility Criteria:
Inclusion Criteria:

* Infants in the Newborn Intensive Care Unit with an NG Tube

Exclusion Criteria:

* Infants with congenital or genetic abnormalities
* Infants with gastroschesis
* Infants with upper airway abnormalities
* Infants receiving any supplement or medication know to alter pH gastric contents
* Infants receiving Enfamil liquid human milk fortification
* Infant who are NPO status
Atherothrombosis Markers in Diabetics

Intraplaque hemorrhage is the driving force of atherothrombotic plaque vulnerability to rupture and associated clinical complications. Polymorphonuclear neutrophils (PMNs) represent about 70% of leukocytes and may constitute a source of proteases and oxidants that favour plaque rupture. Our objective is to evaluate PMN activation in atherosclerotic plaque of non-diabetic versus type 2 diabetic patients. For this purpose, investigators will quantify the presence of cell-free DNA, that reflect the formation of neutrophil extracellular traps (NETs) in carotid endarterectomy samples.

Atherothrombotic plaques of type 2 diabetic patients are characterized by increased neovascularization and associated intraplaque hemorrhage relative to non-diabetic patients that could account for a major incidence of clinical complications. In parallel, Type 2 diabetic patients are characterized by an increased intracellular oxidative stress in circulating PMNs leading to a primed phenotype. PMN priming could be triggered via their receptor for advanced glycation endproducts. In particular, glycated albumin may activate NADPH oxidase and thus promote the production of reactive oxygen species. Under strong activation, PMNs have been described to release NETs that are constituted by externalized nucleosomes associating DNA, histones and enzymes initially present in granules (such as myeloperoxidase, matrix metalloproteinase 9 or elastase). Our hypothesis is that in diabetic conditions, PMNs could be activated within atherothrombotic plaques and thus represent a trigger for plaque rupture. In the present study, we will evaluate PMN activation in carotid plaques of diabetic vs non-diabetic patients as well as in plasma samples of the same patients. For this purpose, all patients that will undergo carotid surgery by endarterectomy will be enrolled in our study and blood samples will be collected the day before the surgery for preparation of plasma and serum. The endarterectomy sample will be collected, dissected into culprit area of the plaque (CP) and the adjacent non-complicated plaque (NCP), incubated separately in culture medium for 24h at 37°C. The resulting conditioned medium will be aliquoted and stored at -80°C for the different assessments. A representative section of the CP will be saved at the moment of dissection for histological evaluation (presence of neovessels/intraplaque hemorrhage, calcifications, lipids, etc). Markers of neutrophil activation, of intraplaque hemorrhage, of glycation and of oxidative stress will be quantified in both conditioned medium and plasma.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with planned endarterectomy
* Affiliated to social security rights
* Signed inform consent

Exclusion Criteria:

* pregnancy
* Autoimmune disease, chronic inflammatory disease, neoplasia
* Type 1 diabetes
ABC Trial: Awakening and Breathing Controlled

The purpose of this study is to determine the impact of a new RN/RRT (Registered Nurse/Registered Respiratory Therapist) directed 2-step protocol to wean patients off of a ventilator. This protocol involves daily attempts to halt sedation (spontaneous awakening trials) combined with daily assessments of patients while they are breathing on their own (spontaneous breathing trials).

Unnecessary delays in removing patients from mechanical ventilation increase morbidity, mortality, and cost. According to recently published guidelines, the current standard of care for weaning involves the daily assessment of patients while they are breathing spontaneously, also known as spontaneous breathing trials (SBT). While there are important data to support a daily cessation of sedatives and analgesics to the point of patient awakening, the benefit of combining such a daily spontaneous awakening trial (SAT) and an SBT is not known.

This multi-center, randomized controlled trial will test whether a 2-step process of weaning that combines a daily awakening trial (achieved by stopping all sedatives and narcotics every morning) with a daily spontaneous breathing trial is superior to the current standard of care.

The number of days the patient is able to live off the ventilator is the primary question being studied. The secondary questions include the number of days the patient is in Intensive Care Unit (ICU) and the hospital, the complications associated with being on the ventilator (such as the duration and severity of delirium and coma), and in-hospital and one-year mortality. Also, cognitive, psychological, and functional/quality of life outcomes will be measured at discharge and 3 and 12 months later.

In addition, the study will measure plasma drug levels twice daily on five sequential days within 30 minutes of testing with highly reliable and well validated instruments to measure sedation level (i.e., RASS) and delirium (i.e. CAM-ICU).

Eligibility Criteria:
Inclusion Criteria:

* Recently on mechanical ventilation (less than 2 weeks prior to enrollment)
* Require mechanical ventilation for more than 12 hours
* Over 18 years old
* Under the services of medicine, cardiology, and neurology

Exclusion Criteria:

* Admission after cardiopulmonary arrest
* Inability to obtain informed consent
* Existence of an extubation order at the time of the evaluation
* Dependence upon mechanical ventilation for 2 weeks prior to enrollment
Botulinum Toxin for Trigeminal Neuralgia

Trigeminal neuralgia (TN) is one of the most painful and common types of neuropathic pain encountered by clinicians. It is typically treated pharmacologically with anticonvulsants,but these can be ineffective, or can lose their effectiveness over time.Botulinum toxin type A (BoNT-A) is an exotoxin released by the Gram-positive, anaerobic bacillus Clostridium botulinum that causes flaccid paralysis by blocking neurotransmitter release by axonal terminals. As a contaminant, it is the cause of potentially lethal botulism poisoning; however, as a drug, it has been widely used in the treatment of dystonia, as well as for non-surgical cosmetic treatment. More recently, studies investigating the ability of BoNT-A to treat pain have been increasing. In 2012, the investigators reported the results of a randomized, double-blind, and placebo-controlled trial in which subcutaneous injection of BoNT-A at the site of pain provided long-term effective relief in TN. The investigators noted that adverse effects were mild, as well. Other studies on TN have estimated the effectiveness of BoNT-A treatment in TN to be 47-73%. However, BoNT-A treatment is still ineffective in more than 30% of patients.In this study, the investigators investigate whether different treatment methods have different efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Clinical diagnosis of classical trigeminal neuralgia according to the ICHD III (beta)
* The pain involved the gingiva
* Signed informed consent prior to entering study

Exclusion Criteria:

* comorbid diseases that may be exacerbated by botulinum toxin type A (e.g., myasthenia gravis, motor neuron disease, or Lambert-Eaton syndrome).
* receiving drugs with neuromuscular junction toxicity 1 week before botulinum toxin type A treatment (e.g. quinine, aminoglycosides or penicillamine)
* had an infection of the skin or mucosa at any of the injection sites.
* psychiatric illness.
* malignancy.
* pregnancy or lactation.
* currently participating or previously participated in any investigational drug or device study within 6 months.
Folic Acid for Prevention of Contrast Induced Nephropathy

The purpose of this study is to determine whether periprocedural administration of folic acid is effective in the prevention of contrast induced nephropathy in patients undergoing coronary CTA/angiography/angioplasty.

Hyperhomocysteinemia is considered to be independently associated with a greater risk of contrast induced nephropathy (CIN) in previous studies. However, the relationship between homocysteine-lowering therapy and CIN remains uncertain. Folic acid is considered to be the most common agent for homocysteine-lowering therapy. Therefore, this study aims to determine whether periprocedural administration of folic acid is effective in the prevention of CIN. 400 patients undergoing coronary CTA/angiography/angioplasty are going to be initially enrolled. Of these patients,200 were randomly assigned to receive a standard dose of folic acid (5mg tid, given at least two days before the procedural and continued for two days after), 200 to receive placebo. Blood samples for estimations of serum creatinine were collected at 0, 24 and 48h of contrast agent administration. CIN is defined as an elevation of creatinine by ≥ 25% or ≥ 0.5 mg/dl from baseline within 48h. The occurrence of CIN and the major in-hospital clinical events were recorded and compared between the intervention and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients undergoing coronary CTA/angiography/angioplasty

Exclusion Criteria:

* exposure to nephrotoxic drugs prior to or during the study period
* end-stage renal failure requiring dialysis
* allergy to iodine-containing contrast medium
* pregnancy
* refusal to give informed consent
Registration of the Study of Reyanning Mixture

The purpose of this study is to evaluate the efficacy and safety of treating with acute tonsillitis using Reyanning mixture alone/in combination with antibiotics, and its function of reducing the use of antibiotics.

In order to evaluate the efficacy,safety and the function of reducing the use of antibiotics of Reyanning mixture (a mixture of Chinese herbal medicine) in treating with acute tonsillitis, a randomized, double-blind, placebo-controlled, multicenter clinical trials will be established. According to the relevant regulations of the China Food and Drug Administration(CFDA), 144 cases need to be registered at least. The aim population is who suffering of acute tonsillitis from October 2018 to December 2019.These cases will be randomly divided into treatment group 1(Reyanning mixture +amoxil capsule simulator),treatment group 2(Reyanning mixture +amoxil capsule) and control group(Reyanning mixture simulator +amoxil capsule).Each group will be treated for 7 days and followed up for 3 times . The main indicators include the recovery time/rate and antibiotic duration/dosage. And the vanish rate of single symptom/physical sign, the ratio of white blood cell count(WBC) recovery, the time of fever will be observed as well.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria of acute tonsillitis;
2. Meet the traditional Chinese medicine symptom diagnostic criteria of external wind-heat type and excessive heat in the lung and stomach type;
3. 18 years≤age≤65 years;
4. course of disease within 72 hours;
5. sign informed consent.

Exclusion Criteria:

1. common cold,influenza, acute laryngopharyngitis, pharyngeal diphtheria, wensang's isthmitis.
2. complicated with acute tracheobronchitis,pneumonia,rheumatic fever, acute glomerulonephritis or rheumatic heart disease.
3. complicated with severe angiocardiopathy, cerebrovascular disease, hemopoietic system disease or psychopath.
4. liver or kidney function is abnormal(ALT\>1.5 times upper limit of normal; Cr\>upper limit of normal); diabetic.
5. WBC\<10×109/L and neutrophilic granulocyte percentage\<75%;or WBC ≥20×109/L;
6. gestational, lactating women or who planning to get pregnant within half a year.
7. already accept similar traditional Chinese medicine or antibiotic within 48 hours before registered.
8. joining other clinical trials or allergic to any drug in this trials.
Cranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics

To improve patient selection for head CT, a safe and high sensitivity screening neuroimaging modality is needed. Currently many clinicians must make treatment decisions based solely on the patients clinical exam, which has low sensitivity and specificity and low inter-rater reliability. This study is being done to learn more about B-mode cranial point-of-care ultrasound (cPOCUS). Ultrasound has several advantages. It is a safe, non- invasive, low-cost, fast and portable bedside tool without ionizing radiation exposure.

B-mode cranial point-of-care ultrasound (cPOCUS) being used in this study is an innovative, low-risk, inexpensive solution for diagnosing clinically significant intracranial pathology in children presenting with blunt head trauma which could be valuable for resource- austere environments. Traumatic brain injury remains a leading cause of death and disability in children. In addition, those who present with suspected acute brain injury in resource-austere environments may be at high risk of long-term neurologic sequelae or death. Early neuroimaging to identify traumatic brain injury and guide interventions is key to preventing their neurologic morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring a head computed tomography (CT) as the standard of care
* Seen in the pediatric Emergency Department or Pediatric Intensive Care Unit at Atrium Health Wake Forest Brenner Children's Hospital or Levine Children's Hospital

Exclusion Criteria:

* Patients with open skull fractures
* Previous hemicraniectomy
* Existing surgical defect in the skull
* Patients being transitioned to comfort care
A Study to Evaluate the Efficacy and Safety of Vismodegib in Combination With Ruxolitinib for the Treatment of Intermediate- or High-Risk Myelofibrosis (MF)

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vismodegib plus (+) ruxolitinib versus placebo + ruxolitinib in participants with intermediate- or high-risk MF. The study will be divided into 2 components. The Phase Ib portion of the study consists of participants receiving open-label vismodegib (150 milligrams \[mg\] orally \[PO\] once daily \[QD\]) + ruxolitinib (PO twice daily \[BID\]). A safety assessment will be performed after the first 10 participants have been treated for 6 weeks. An analysis for efficacy and safety is planned in the first 10 participants at Week 24. There will be a hold on participant screening and enrollment during this assessment. Another 10 participants may be enrolled, thereafter, to further assess efficacy and safety (at Week 24) before the initiation of the Phase III randomization portion of the study. Similarly, there will be another hold on participant screening and enrollment during this assessment. The participants enrolled in the Phase Ib portion of the study will continue to receive vismodegib (150 mg PO QD) + ruxolitinib (PO BID) for up to 48 weeks, if clinical benefit is observed after 24 weeks. The Phase III randomized, double-blind portion of the study will enroll approximately 84 participants. Participants will be randomly assigned in a 1:1 ratio (double blind) to receive either vismodegib (150 mg PO QD) + ruxolitinib (PO BID) or placebo (PO QD) + ruxolitinib (PO BID) for up to 48 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diagnosis of primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF, according to the 2008 revised World Health Organization criteria
* Intermediate-1, intermediate-2, or high-risk according to the IWG-MRT Dynamic International Prognostic Scoring System
* Life expectancy \>= 6 months
* Peripheral blood blast count of less than (\<) 10%
* Palpable splenomegaly of greater than (\>) 5 centimeters (cm) below the left costal margin
* Eastern Cooperative Oncology Group performance status of 0 to 2
* Adequate hepatic and renal function

Exclusion Criteria:

* Prior treatment with a Hedgehog or Janus kinase pathway inhibitor
* Treatment with strong cytochrome P450 3A4 inhibitors/inducers within 28 days prior to Day 1
* Prior therapy for the treatment of intermediate- or high-risk MF including chemotherapy, interferon, thalidomide, busulfan, lenalidomide, anagrelide, or androgens within 28 days prior to Day 1
* Prior splenectomy or splenic irradiation
* Inadequate bone marrow reserve
* Participants with any history of platelet counts of \< 50,000/mccL or ANC of \< 500/mL, except during treatment for myeloproliferative neoplasm or treatment with cytotoxic therapy for any other reason
* Planned allogeneic bone marrow transplant during the study