cyrilzakka/clinical-trials huggingface dataset:
Will a Real Time Advisory for Double Low State Change Clinical Behavior and Impact Outcomes

The objective of this study is to use a decision-support system combined with an electronic anesthesia record to detect double low clinical conditions (Mean Arterial Pressure (MAP) \< 75 mmHg, and Bispectral Index (BIS) \< 45) and generate alerts suggesting hemodynamic support. Specifically, the project will test the hypothesis that providing Double Low alerts reduces 90-day mortality. Secondary outcomes will be the fraction of alerts that generate early clinician responses, subsequent changes in MAP and hospital length of stay.

Data that is routinely collected as part of standard of care intraoperative monitoring including blood pressure, amount of anesthetic administered and a form of processes electroencephalogram called the bispectral index, which is a measure of depth of anesthesia all enter in an electronic record keeper. This project monitors for a combination of a blood pressure below mean of 75mmHg and a BIS of 45. When this is detected, half of the anesthesiologists caring for patients receive a text message on the computer screen and their pagers indicating that a double low situation exists and that they should consider intervening. The other half of practitioners are not provided with the additional messages, although all of the same information is available in the operating room (OR). Most patients undergoing general non-cardiac anesthesia at Mount Sinai are eligible. Documentation of consent was waived. All patients are informed of the ongoing project upon admission and are given a variety of methods of opting out of the project.

The analysis seeks to determine if the messages were effective at influencing clinician behavior and whether that change would make a difference in either length of stay or 90 day mortality.

Eligibility Criteria:
Inclusion Criteria:

* All patients presenting for general anesthesia and have BIS monitors

Exclusion Criteria:

* patients who opt out of the study
Mobile Strategies for Women's and Children's Health: Optimizing Adherence and Efficacy of PMTCT/ART

The investigators are conducting a 3-arm randomized trial comparing the effects of unidirectional SMS (ie: "push" messaging to participant) vs. bidirectional SMS dialogue between participant and provider vs. control (no SMS) among HIV-infected Kenyan mothers in Kenyan PMTCT-ART for outcomes of ART adherence and retention in care.

The investigators will compare trial arms for impact on maternal retention, adherence, virologic failure and resistance and infant HIV or HIV-free survival.

The investigators will determine correlates of maternal loss to follow-up and virologic failure and correlates of infant HIV in the overall study and stratified by trial arm. In the bidirectional SMS arm, the investigators will determine the rate of SMS interactivity, impact of critical time-points on messaging, and characteristics of high and low 'interactors'.

The investigators will determine cost-effectiveness of unidirectional and bidirectional SMS interventions. These data will contribute a potential scale-able strategy to improve PMTCT-ART as programs aspire to 'virtual elimination' of infant HIV.

Eligibility Criteria:
Inclusion Criteria:

* pregnant, HIV-infected, access to a mobile phone, remaining in study area for two years

Exclusion Criteria:

* enrolled in another research study
The Effect of Physical Training and the Omega 3 Consumption on Attention Deficit Hyperactivity Disorder in Children

The attention deficit hyperactivity disorder (ADHD) usually occurs in preschool and may cause disabilities through whole life.

The attention deficit hyperactivity disorder (ADHD) usually occurs in preschool and may cause disabilities through whole life. The treatment of this disease is expensive and difficult. Moreover, physical exercise and omegas consumption may improve the cognitive functions and behavior, so it could be an interesting strategy to improve this disorder. The aim of the present study is to verify the effects of multiple components physical training and the consumption of omega 3 on behavior, cognitive functions and the serum levels of BDNF and IGF-1 in ADHD children. Thus, 68 ADHD children, between seven and fourteen years old will be selected. The volunteers will be randomly divided into four groups: Physical Training Group (PTG), Omega Group (OG), Omega and Physical Training Group (OPTG) and Control Group (CG). The protocol of the experiment will last three months in which the OPTG will make physical training and receive fish oil capsules, and the PTG will make only the physical training and receive a placebo of fish oil. The others groups will be oriented not to make any type of physical training, but the OG will receive fish oil capsule, and the CG will receive a placebo of fish oil. Behavioral and cognitive functions evaluations and blood analysis will be made at the beginning and at the end of the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Children with ADHD: male, between seven and fourteen years old, sedentary, studing in a regular school.

Exclusion Criteria:

* Taking psychoactive medications, taking omega supplement.
Incidence, Risk Factors, and Risk Model of Acute Kidney Injury in Pediatric Patients Who Undergoing Surgery for Congenital Heart Disease

Acute kidney injury (AKI) is a major complication after cardiac surgery and has been reported to be associated with adverse outcome. Previous studies have reported that the incidence of AKI in patients undergoing surgery for congenital heart disease is as high as 42% and AKI increase the patient mortality, intensive care unit stay and hospital stay. Previous studies have reported several risk factors for AKI after congenital heart surgery, however, perioperative variables including anesthesia-related factors have not been evaluated fully. Therefore, the investigators attempt to find out independent risk factors regarding perioperative variables.

Acute kidney injury (AKI) is a major complication after cardiac surgery and has been reported to be associated with adverse outcome. Previous studies have reported that the incidence of AKI in patients undergoing surgery for congenital heart disease is as high as 42% and AKI increase the patient mortality, intensive care unit stay and hospital stay. Previous studies have reported several risk factors for AKI after congenital heart surgery, however, perioperative variables including anesthesia-related factors have not been evaluated fully. In addition, a neutrophil-lymphocyte ratio (NLR), which have been reported to be a marker for systemic inflammation and associated with prognosis of cardiac and cancer patients might be able to predict development of postoperative AKI. Therefore, the investigators attempt to assess independent risk factors regarding perioperative variables including transfusion-related parameters, preoperative anemia, preoperative hypoalbuminemia, pulmonary hypertension, use of nitric oxide, use of hydroxyethyl starch, perioperative medication, hemodynamic variables and perioperative NLR.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent surgery for congenital heart disease between January 2012 and December 2012 in Samsung Medical Center

Exclusion Criteria:

* incomplete data for creatinine, estimated glomerular filtration rate, or urine output required to diagnose acute kidney injury
* patients who expired within 24 hours after surgery
Imatinib in Dermatofibrosarcoma Protuberans (DFSP)

The purpose of this study is to determine whether imatinib is effective in the treatment of primary and recurrent dermatofibrosarcoma protuberans (DFSP).

This study is aimed to investigate the efficacy of imatinib (Glivec) in the treatment of primary and locally relapsed dermatofibrosarcoma protuberans (DFSP). DFSP is a cutaneous neoplasm well known for its overexpression of the platelet-derived growth factor (PDGF). Herein, imatinib provides a systemic treatment option that offers the possibility of a reduction of the wide surgical margins used today in surgery of primary DFSP, or even of a complete avoidance of surgical treatment in this disease. Since imatinib exerts its function via interference with protein tyrosine kinase activities, it inhibits the platelet-derived growth factor receptor (PDGF-R) signaling cascade that plays a crucial role in the pathogenesis and tumor growth of DFSP. Since imatinib has been shown to shrink metastatic lesions of DFSP, there is a strong rationale to expect that it also decreases cell proliferation and tumor growth in primary DFSP.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of primary or recurrent dermatofibrosarcoma protuberans
* Measurable tumor parameters (by magnetic resonance imaging \[MRI\])
* Patient \>/= 18 years of age
* ECOG performance status \< 3
* Adequate organ function
* Patients must be able to swallow capsules
* Female patients of childbearing potential must have negative pregnancy test
* Written, voluntary, informed consent; must include investigational use of tumor tissue biopsies.

Exclusion Criteria:

* Any evidence of distant metastases
* Patient has received any other investigational agents within 28 days of first day of study drug dosing
* Patient is \< 5 years free of another primary malignancy except basal cell skin cancer or cervical carcinoma in situ
* Grade III/IV cardiac problems as defined by the New York Heart Association
* Severe and/or uncontrolled medical disease
* Known diagnosis of human immunodeficiency virus (HIV) infection
PREVENTion of Clot in Orthopaedic Trauma

The purpose of this study is to compare aspirin versus low-molecular weight heparin (LMWH) (Enoxaparin) as a thromboprophylaxis in patients who sustain a fracture.

Patients who sustain orthopaedic trauma are at an increased risk of venous thromboembolism (VTE), including fatal pulmonary embolism (PE). Current guidelines recommend low-molecular-weight heparin (LMWH) for VTE prophylaxis in orthopaedic trauma patients. However, emerging literature in total joint arthroplasty patients suggests the potential clinical benefits of VTE prophylaxis with aspirin. This trial aims to determine if aspirin is non-inferior to LMWH for thromboprophylaxis in fracture patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have a planned operative or non-operative pelvis or acetabular fracture, or any operative extremity fracture proximal to the metatarsals or carpals.
* Patients at increased risk of blood clot(s) from their orthopaedic injury(ies) and will receive prophylactic blood thinner regimen per standard of care.
* Patients 18 years or older.

Exclusion Criteria:

* Patients who present to the hospital more than 48 hours post injury
* Patients who received more than 2 doses of LMWH or aspirin for initial VTE prophylaxis
* Patients on long term blood thinners (other than low-dose aspirin or platelet inhibitors such as Plavix or Aggrenox)
* Patients who have had a VTE within the last 6 months
* Patients on therapeutic (as opposed to prophylactic) blood thinners for an acute issue at the time of admission
* Patients who have a newly diagnosed indication for therapeutic blood thinners (for example vascular injury) that will require therapeutic anticoagulation for more than one week
* Patients who cannot receive either of the study medications due to an allergy (history of heparin induced thrombocytopenia, allergy to aspirin, or NSAIDs) or other medical contraindication to blood thinners
* Patients who are on higher dose aspirin (\>81 mg once a day or higher) for medical reasons or who will be treated with higher dose aspirin
* Patients with underlying chronic clotting disorders (i.e. Factor V Leiden, hyperhomocysteinemia, Protein C and S deficiency) that require full dose anticoagulation or are a contraindication to venous thromboembolism chemoprophylaxis
* Patients with end stage renal disease or impaired creatinine clearance \<30 ml/min at time of randomization(note: creatinine clearance does not need to be documented if prescribing physician would order medication without test as SOC)
* Pregnant or lactating patients
* Prisoners
* Patients who do not speak either English or Spanish
* Patients who are likely to have severe problems maintaining follow-up
* Patients, based upon the clinical judgment of the treating clinician, NOT equally suited for treatment with either aspirin or low-molecular-weight heparin
* Patients may be excluded for other reasons at the discretion of the treating physician; the reason for exclusion must be documented on the screening form
* Patients who have a known COVID-19 diagnosis prior to fracture treatment or within 3 months of the index fracture
Glutamine Supplement in MELAS (Mitochondrial Encephalopathy, Lactic Acidosis, and Stroke-like Episodes) Syndrome

The purpose of this study is to assesses the efficacy of oral supplementation with glutamine over three months on several amino acids and lactate concentration measured in cerebrospinal fluid and cerebral lactate measured by magnetic resonance spectroscopy.

Mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes (MELAS) syndrome is a genetically heterogeneous disorder. The most common mutation is in the mtDNA gene MT-TL1 encoding the mitochondrial tRNALeu (UUR). For understanding the development of seizures in patients with mitochondrial disease, a study has recently emphasized the deficiency of astrocytic glutamine synthetase, creating a disinhibited neuronal network for seizure generation. The investigators propose to evaluate nine patients with mitochondrial DNA mutation and MELAS. Patients will receive oral supplementation with 10-15 g/day of glutamine (adjusted for weight and plasma concentrations). The primary outcome measures several amino acids (including glutamine) and lactate concentration measured in cerebrospinal fluid and cerebral lactate measured by magnetic resonance spectroscopy.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of MELAS syndrome is based on medical history (lactic acidosis, stroke-like episodes, and encephalomyopathy).
* Subjects have to be clinically stable for more than six months after any stroke-like episodes.
* All subjects have to be genetically confirmed.

Exclusion Criteria:

* Subjects harboring a MELAS-related pathogenic mtDNA mutation, no fulfilling the complete diagnostic criteria for the MELAS phenotype.
How Urban Interventions in Lower Socioeconomic Areas Influence Health Behaviors (UrbASanté Study)

The UrbASanté study is a quasi-experimental research that aimed at assessing the impact of urban transformations (a natural experiment) in the health related behaviors, environmental exposure and perceived- health.

The UrbASAnté study is an interdisciplinary project evaluating the relationships between urban transformations (urban regeneration programs) and health related behaviors, environmental exposure (air pollution, noise) and health (perceived) in a deprived neighborhood in Paris (France).

UrbASanté consists of quasi-experimental research (before/after protocol design) and includes an "exposed" group of inhabitants living in a neighborhood with urban transformation (intervention) and an "unexposed group" comprising inhabitants from neighborhood not undergoing urban changes (control).

Participants will be surveyed at enrollment and 24 months later.

Eligibility Criteria:
Inclusion Criteria:

* Living in areas with urban intervention in Porte de la Chapelle, Paris (for experimental group)
* Living in areas without direct urban interventions close to Porte de la Chapelle, Paris (for control group)
* Age above 18 years
Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery

The purpose of this study is to determine the safety, optimal dose and imaging time of the investigational product, IRDye800CW-nimotuzumab for use as a near infrared imaging probe for image-guided surgery during lung cancer resection. IRDye800CW-nimotuzumab targets cancer cells over-expressing EGFR, allowing tumors to be visualized and may help surgeons better identify cancer during surgery.


Eligibility Criteria:
Inclusion Criteria:

* Surgically resectable Stage I and II non-small cell lung cancer
* Able to give informed consent
* Age ≥ 18 and ≤ 80 years old
* Adequate cardiopulmonary reserve to undergo lung resection as determined by operating surgeon
* No prior history of malignancy
* No neoadjuvant therapy
* Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2
* Hemoglobin (hgb) ≥ 90 g/L
* White blood cell count (WBC) \> 3 x 109/L
* Platelet count (plt) ≥ 100 x 109/L
* Serum creatinine ≤ 1.5 times upper reference range

Exclusion Criteria:

* Received anti-EGFR antibody therapy (cetuximab, panitumumab, necitumumab) within 60 days prior to trial drug
* Pregnant or nursing
* Known history of hypersensitivities or allergic reactions to antibodies or NSO derived products
* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
* Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
* Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
IORT on Borderline Resectable Pancreatic Cancer

This phase II study investigates the efficacy of IORT for patients with borderline resectable pancreatic cancer. The purpose of the study is to investigate whether the addition of IORT, after FOLOFIRINOX-base chemotherapy, and SBRT, increases the 3-year survival rate. A total of 101 patients will be enrolled, and these patients will receive IORT of 10 to 20 Gy, according to the resection status (to the tumor bed after resection, or to the tumor in situ in case of non-resection).

Treatment outcomes of borderline resectable pancreatic cancer are still poor even after completion of FOLFIRINOX-based chemotherapy and radical resection. A growing body of literature is demonstrating that Stereotactic body radiation therapy (SBRT) and Intraoperative radiotherapy (IORT), within a multimodal approach, allow to obtain better oncological outcome, at the price of low to negligible rates of morbidity and mortality. The investigators hypothesize that a "total neoadjuvant" scenario, with the best current therapy, based on up to 6 months of FOLFIRINOX (minimum 4), SBRT and IORT (in situ or after surgery) would increase the disease-specific survival of borderline resectable pancreatic cancer patients. An historical cohort will be used as a comparison group.

Considering the intention-to-treat design and the institutional rates of chemotherapy completion and exploration/resection of borderline resection pancreatic cancer patients, a total of 100 patients will be enrolled in this phase II trial. Patients submitted to IORT, will receive IORT of 10 to 20 Gy according to the resection status (to the tumor bed after resection, or to the tumor in situ in case of non-resection).

Eligibility Criteria:
Inclusion Criteria:

* • Biopsy-proven, previously untreated borderline resectable PC, defined according to the NCCN guidelines v1.2019;

  * Age 18-80 years;
  * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
  * Adequate bone marrow function (absolute neutrophil count ≥1500 per cubic millimeter; platelet count ≥100.000 per cubic millimeter; hemoglobin level ≥10 g per deciliter), liver function (serum total bilirubin level ≤1.5 times the upper limit of the normal range), and renal function (creatinine clearance ≥50 ml per minute);
  * Ability to understand the characteristics of the clinical trial;
  * Written informed consent.

Exclusion Criteria:

* • Ampullary, biliary, or duodenal adenocarcinoma; pancreatic adenocarcinoma in the background of an intraductal papillary mucinous neoplasia (IPMN), other uncommon pancreatic adenocarcinomas (acinar-cell, squamous, giant-cell osteoclastic-like);

  * Invasive cancer in the last 5 years requiring radiation therapy to the upper abdomen or chemotherapy;
  * Symptomatic heart failure or coronary artery disease;
  * Pregnant or lactating women;
  * Impaired mental state or language problems.
A Study of Metabolic Agents Following Brain Radiation

This study is being done to determine if CEST magnetic resonance imaging (MRI) and FDG PET are feasible techniques to detect metabolic differences between tumor and brain in patients with a brain tumor.


Eligibility Criteria:
Inclusion Criteria:

* Radiographic evidence or histopathologic confirmation of CNS malignancy, with or without prior resection.
* Provide written informed consent for the current study.
* Willing to undergo at least one MRI (and possibly more at PI discretion) with proton and/or phosphorus magnetic resonance spectroscopy analysis.

Exclusion Criteria:

* Vulnerable populations: pregnant or nursing women (Arm B exempt), prisoners, mentally handicapped.
* Cardiac pacemaker or artificial heart valve
* Metal plate, pin, or other metallic implant
* Intrauterine device, such as Copper-7 IUD
* Insulin or other drug pump
* Non-titanium aneurysm clips
* Previous gunshot wound
* Cochlear implant or other hearing device
* Employment history as a metalworker (had metal in eye)
* Permanent (tattoo) eye-liner
* For FDG-PET specifically: Fasting blood sugar level greater than 200mg/dl
[18F]ISO-1 Positron Emission Tomography (PET/CT) in Primary Breast Cancer

In this study, positron emission tomography (PET/CT) imaging will be used to evaluate sigma-2 (σ2) receptor activity in sites of primary breast cancer using the investigational radiotracer \[18F\]ISO-1.

This study will evaluate the feasibility of using \[18F\]ISO-1 PET/CT to image sigma-2 receptor binding in primary breast tumors and continue to evaluate the safety of the tracer in this patient population. \[18F\]ISO-1 uptake measures will be correlated with qualitative immunohistochemical staining for cell proliferation (Ki67). This is an observational study in that \[18F\]ISO-1 PET/CT will not be used to direct treatment decisions.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients, at least 18 years of age
2. Known or suspected breast cancer with at least one breast lesion that is 1 cm or greater in size by standard imaging (e.g. mammography, ultrasound or breast MRI)
3. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures

Exclusion Criteria:

1. Females who are pregnant at the time of screening will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening.
2. Inability to tolerate imaging procedure in the opinion of an investigator or treating physician
3. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
4. Unwilling or unable to provide informed consent.
Child Development and Genetic Biomarkers

A study of the relation between genetic biomarkers and child development in Taiwan.

The interaction between gene and environment (G×E) can be a very complicated process that influences child development. As a pilot study of child development biomarkers, this study investigates genes related to child development.

Eligibility Criteria:
Inclusion Criteria of Healthy Child:

* Age 2-18 y/o
* Agree to sign informed consent

Exclusion Criteria of Healthy Child:

* Central nervous system disease
* Neuromuscular Disorders
* Congenital Abnormality
* Genetic Disease
* Dysesthesia
* Hearing Impairment

Inclusion Criteria of Child with developmental delay:

* Patients with Language Disorder
* Age 2-18 y/o
* Agree to sign informed consent

Exclusion Criteria of Child with developmental delay:

* Hearing Impairment

Inclusion Criteria of Adult:

* His or her child participated in this study, and gene abnormality was found.