cyrilzakka/clinical-trials huggingface dataset:
Using Salt to Improve Micronutrient Status

Question: How effective is folic acid-fortified iodized salt in increasing serum folate concentrations among non-pregnant and non-lactating women of reproductive age? Hypothesis: Folic acid-fortified iodized salt can increase serum folate levels and serve as a policy consideration in salt fortification with both iodine and folic acid to reduce serious and fatal birth defects.

Salt is an ideal vehicle for fortification because its universal consumption and often centrally processed with established distribution channels. Over 70% of households globally have access to iodized salt. Considering the success of salt iodization, it is logical to use the existing infrastructure to provide folic acid through this dietary mechanism.

AIM:To assess increase in blood folate concentrations among women of reproductive age after they consume folic acid-fortified iodized salt.

OBJECTIVES :

1. To examine the effect of consumption of salt fortified with folic acid on serum/plasma folate concentrations among women of reproductive age.
2. To assess acceptance of study salt for daily use during 3 months of consumption.

Eligibility Criteria:
Inclusion Criteria: • Willing to voluntarily participate in the study

* Can comprehend and comply with study requirements
* Aged between 18 and 45 years.
* No documented issues with child bearing potential
* Resident of the area of study for duration of study.
* Consume only study salt during study

Exclusion Criteria:

* Taking multivitamins or FA during study
* Pregnant or lactating at recruitment or during study
* Co-morbidities such as Malabsorption disorders, severe anemia (Hgb \<8.0 g/dL), uncontrolled hypertension, (SBP ≥140 mm Hg or DBP ≥90 mm Hg), HIV, active TB or malaria infection
* History of prior SBA delivery
* Pre-existing medical conditions (i.e., cancer or need for regular medications)
Accuracy and User Performance Evaluation of PixoTest HbA1c Measurement System

To evaluate the accuracy user performance of PixoTest HbAc1 measurement system and to collect feedback from subjects.

According to WHO report, the number of people with diabetes has risen from 108 million in 1980 to 422 million in 2014. Diabetes is a major cause of blindness, kidney failure, heart attacks, stroke and lower limb amputation. In 2012 alone diabetes caused 1.5 million death. Tight glucose control is essential for prevention of complications in people with diabetes. The Diabetes Control and Complications Trial (DCCT) provided direct evidence the relationship between HbA1c level and risks for diabetic complications in diabetes. Based on the results of the DCCT, the American Diabetes Association (ADA) has published recommendations for HbA1c and plasma glucose levels that are widely used. HbA1c testing can be performed at any time of day and without special patient preparation, it is more convenient for patients and even measuring fasting plasma glucose.

The ADA recommends measurement of HbA1c (typically 3-4 times per year for type 1 and poorly controlled type 2 diabetic patients, and 2 times per year for well-controlled type 2 diabetic patients) to determine whether a patient's metabolic control has remained continuously within the target range. .Most diabetes patients will go to hospital to measurement HbA1c, but should wait few days for test result. Most diabetes patient maybe not measurement HbA1c so many time per year. The PixoTest HbA1c measurement system can give result for a few minutes at home. The diabetes patient can measure HbA1c at home don't need go to hospital.

The PixoTest HbA1c measurement system is defined as the respective reagent system and the corresponding smartphone. It is intended for quantitative measurement of HbA1c in capillary whole blood and use in the home by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control.

This study is designed to test the accuracy and user performance of the Pixotest HbA1c measurement system.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older.
2. Willing to participate in the study, able to read and provide written informed consent form.
3. HCT 25\~65%.
4. Subjects including healthy subjects, outpatients and inpatients.

Exclusion Criteria:

1. An individual who does not meet the inclusion criteria will be excluded from enrollment.Taking prescription anticoagulants (such as Warfarin or Heparin) or have clotting problems that may prolong bleeding. Taking Plavix or aspirin daily is not excluded.
2. Hemophilia or any other bleeding disorder
3. Reports having an infection with a blood borne pathogen (e.g. HIV, hepatitis)
Oral Azacitidine Maintenance Post-CPX 351

Approximately 10% of patient develop AML after chemotherapy or radiation for unrelated disease (t-AML) and 20% have AML with an antecedent hematologic disorder (AML-MRC). CPX-351 (Vyxeos), a liposomal formulation of a fixed molar ratio (1:5) daunorubicin and cytarabine, has been approved for treatment of adults with newly diagnosed t-AML or AML-MRC. CPX-351 significantly improved median overall survival.

Although induction chemotherapy results in remission in many older patients with AML, relapse is common and overall survival is poor. For patients not eligible for HSCT, maintenance therapies are needed to reduce the risk of relapse and prolong overall survival without causing undue adverse effects or compromising health-related quality of life. Oral azacitidine (ONUREG) has been approved by FDA on September, 2020, to treat adult patients with AML who achieved CR or CRi following intensive induction chemotherapy with or without consolidation and who are not able to complete intensive curative therapy (not candidate to HSCT).

The use of oral azacitidine maintenance is an integral part of clinical practice for AML patients who have achieved a first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after intensive ""3+7"" induction chemotherapy and who are unable to complete intensive curative therapy.

But there are few data on its efficacy as a post-CPX-351 maintenance agent in patients with newly diagnosed t-AML or AML-MRC or de novo AML.THe aim of this study is to show the improvement of overall survival with use of oral Azacitidine as maintenance for patients with de novo AML including t-AML or AML-MRC who achieved complete remission or complete remission with incomplete blood count recovery after CPX-351. Long-term product safety is also being studied


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects \> 64 years of age at the time of C1J1 CPX-351
* de novo AML including t-AML or AML-MRC according to WHO 2016
* Should have undergone induction therapy with CPX-351 with or without CPX-351 consolidation
* Patients in first line of treatment
* Should have achieved first CR/CRi/CRh status according to IWG criteria
* ECOG performance status of 0,1,2,3

Exclusion Criteria:

* Prior bone marrow or stem cell transplantation
* patients having achieved CR/CRi following an added therapy
* Patients alive at the start of the study who did not receive study information or who objected to the collection of data
The Efficacy and Safety of Alemtuzumab in Auotoimmune Cytopenias

The majority of cases of autoimmune cytopenias, which includes immune thrombocytopenia (ITP), autoimmune hemolytic anemia, autoimmune neutropenia (AIN) and pure red cell aplasia, will respond to conventional immunosuppressive therapy with or without splenectomy. There is, however, a group of patients with refractory or chronically relapsing autoimmune cytopenias causing life-threatening hemorrhages, infections or anemia. Further problems include the short- and long-term side-effects of corticosteroids, and the potential toxicity of immunosuppressive and cytotoxic agents. An alternative and less toxic approach in these patients may be the treatment with Campath-1H, a humanized IgG monoclonal antibody specific for the CD52 antigen and present on human lymphocytes and monocytes. The main effect of Campath-1H is on T cell and it results in a prolonged and profound depletion of the CD4 and CD8 subpopulations, particularly the CD4 population, and this might "reset" the immune system without the need for total immune ablation.Therefore, this study is designed to investigate safety and efficacy of repeated Campath treatment cycles in autoimmune cytopenia.In order to minimize possible side effects of accumulating Campath, the 3 treatment cycles will be administered in consecutively reduced doses.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must have a diagnosis of the following autoimmune cytopenias:

   immune thromobocytopenia purpura (ITP) autoimmune hemolytic anemia (AIHA) autoimmune neutropenia (AIN) pure red cell aplasia (PRCA) and
2. Patients must have refractory disease according to the following criteria

   1. not respond to steroids or
   2. need prednisolone more than 15 mg/d for maintenance therapy
3. Complete work up for baseline evaluation and measurement
4. Age \> 18 years
5. Patient's free written inform consent

Exclusion Criteria:

1. Patients with a known hypersensitivity to murine proteins or to any component of alemtuzumab
2. Patients with poor performance status (ECOG criteria of 3-4)
3. Serologic evidence of human immunodeficiency virus exposure
4. Patients with active uncontrolled infection. Patients that are HIV positive or test positive on HBs or HCV antigens.
5. Pregnant or lactating women
6. Serious medical or psychiatric illness which prevent informed consent
7. Patients who are likely to lost to follow up (eg, unwilling or difficult to return, cannot be contacted)
8. Patients with active malignancies
Impact of Cerebral Ventricular Dilatations and Cerebrospinal Fluid Pulsations on Periventricular White Matter in Hydrocephalic Patients

Hydrocephalus is characterized by excessive accumulation of cerebrospinal fluid (CSF) in the ventricles of the brain. One of the forms of hydrocephalus is called "normal pressure", although one of the main signs is precisely an alteration of the intracranial pressure (ICP), it is here called active hydrocephalus (HA). Although MRI is the reference radiological modality for the characterization of HA. The Evan's and DESH index are radiological diagnostic criteria based on the dilation and morphology of the CSF compartments. These morphological indices remain insensitive and specific. In recent years, advances in Phase Contrast (MRI-PC) and Diffusion (MRI-DTI) MRI have generated new biomarkers of brain viability. The aim of this study is to characterize by MRI the impact of hydrocephalus on brain fluids and tissues.


Eligibility Criteria:
Inclusion Criteria:

* For Patients with hydrocephalus:
* Age \> 55,
* Ventricular dilation: Evans Index \> 0.3;
* Patients with cognitive impairment, and gait disturbances and/or urinary incontinence or a combination of these three symptoms;
* Absence of other neurological diseases that could cause ventriculomegaly, information and non-opposition.
* For Controls:
* Age ≥ 55;
* No ventricular dilation: Evans Index \< 0.3;
* Individuals who have no neurological or psychiatric disease;
* No neurological deficit.
* No history of neurosurgery or head trauma;
* signed informed consent;
* affiliation to a social security scheme.

Exclusion Criteria:

* All patients who have a neurological disease other than active hydrocephalus will be excluded;
* Individuals unable to sign or understand consent;
* Individuals with psychiatric, neurological or medical development;
* Individuals under treatment with psychoactive drugs;
* Individuals who cannot tolerate an MRI examination;
* Any individual with implant, pacemaker, prosthesis and ferromagnetic object
Fetus Anemia Diagnosis by Ultrasound Data Collection

The aim of this study is to diagnose anemia in fetuses through the use of ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women from 16th week to 41st week +6 days
* Singleton fetus

Exclusion Criteria:

* All others
Modified T-Stenting With Szabo Technique Versus T-Stenting for Bifurcation Lesions in Coronary Heart Diseases

The study will compare clinical outcomes of modified T-stenting with Szabo technique with T-stenting for bifurcation lesions in coronary heart diseases.

Accurate deployment of stents in ostial lesions is difficult with traditional angiographic guidance. Szabo technique, which used a second angioplasty guide wire to anchor the stent by passing the proximal end of the anchor wire through the last cell of the stent, demonstrated accurate placement of the stents in ostial locations. In bifurcation lesions, 2-stent strategy positioning with Szabo technique was not investigated. Modified T-stenting with Szabo technique may improve prognosis of bifurcation lesions through reducing stents overlap. There is no clinical trial focuses on the effect and outcome of Szabo technique for coronary artery bifurcation lesions in contrast with conventional strategy.

In this study, the authors choose the closest 2-stent strategy, T-stenting, as control. We hope to determine whether a planned Szabo 2-stent technique is superior to T-stenting for patients with bifurcation lesions.

Patients with bifurcation lesions will be randomly assigned to receive Szabo 2-stent technique or T-stenting strategy. Clinical outcomes and imaging assessment will be used to estimate their effects.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be at least ≥18 years of age.
* Lesions are eligible for percutaneous coronary intervention (PCI).
* Patient has stable/unstable angina or myocardial infarction (MI).
* Bifurcation lesions (Medina 1,1,1/0,1,1/1,0,1) without left main ostial lesions.
* Downstream lesions could be covered by two stents.
* Diameter of vessel ≥2.25mm
* Diameter stenosis in main vessel and side branch ≥ 50% by visual estimation.

Exclusion Criteria:

* Severe tortuosity or calcification affected procedural success.
* Patient was allergic to the study stent or protocol-required concomitant medications.
* Patient is intolerable to dual anti-platelet therapy.
* Patient has any other serious medical illness that may reduce life expectancy to\<12 months.
* Patient is a woman who is pregnant or nursing.
* Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation.
* Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure.
* Coronary restenosis.
Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer

The primary objective of the study is to estimate the progression-free survival rate at 12 months for the two arms of the study.

Secondary objectives include the evaluation of overall objective response rate to treatment, progression-free survival, overall survival, safety and documentation of potential immunogenicity of aflibercept.

This study was a non-comparative randomized trial and was not powered for a comparison of any of the efficacy endpoints.

Rather, the aim of the trial was to get, for all endpoints, an estimation of the efficacy and safety of aflibercept combined with a modified FOLFOX6 regimen. In such type of non-comparative randomized trial, the control FOLFOLX6 arm was intended to only act as a check on the similarity of the current patients to the historical controls with respect to clinical outcome when given FOLFOX6 treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma of the colon or the rectum
* Metastatic disease not amenable to potentially curative treatment

Exclusion Criteria:

* Prior therapy for metastatic cancer of the colon or the rectum
* Prior treatment with angiogenesis inhibitors

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Assessment of an Alpha-glucosidase Inhibitor to Block Cardiac Events in Patients With MI and IGT

The purpose of this study is to evaluate whether an alpha-glucosidase inhibitor, a drug for the suppression of postprandial hyperglycemia, could reduce the recurrence of myocardial infarction in patients with impaired glucose tolerance (IGT) and old myocardial infarction.

Type 2 diabetes mellitus is a well-established risk factor for coronary heart disease and atherosclerotic change in the coronary artery develops subclinically in a state of impaired glucose tolerance (IGT). Recently postprandial hyperglycemia as a feature of impaired glucose tolerance is recognized as a significant risk factor for coronary heart disease. So we designed a prospective randomized multi-center trial named Assessment of an α-glucosidase-inhibitor to Block Cardiac Events in Patients With Myocardial Infarction and IGT (ABC study) to evaluate whether an α-Glucosidase Inhibitor, a drug for the suppression of postprandial hyperglycemia, could reduce the recurrence of myocardial infarction in patients with IGT and old myocardial infarction.

100 hospitals will participate in the ABC study. Patients with IGT who have a history of prior myocardial infarction are randomly allocated to receive α-Glucosidase Inhibitor (voglibose) or a standard diet and exercise treatment. The number of patients to be recruited is 3000 and this study will continue for at least 2 years. The primary end-points are:

1. cardiovascular mortality and
2. hospitalization for cardiovascular events.

Effects in suppression of new diabetes development will also be evaluated.

We should recognize IGT as an important therapeutic target to decrease the recurrence of cardiovascular events. The ABC study, a large scale multi-center trial in Japan, will provide us with new evidence on how to treat IGT patients with prior myocardial infarction.

Eligibility Criteria:
Inclusion Criteria:

1. Impaired glucose tolerance
2. History of myocardial infarction

Exclusion Criteria:

1. Type I diabetes
2. History of coronary artery bypass graft
3. Severe liver and/or kidney dysfunction
4. History of allergic response to drugs
5. Arteriosclerosis obliterans
Systems Biology Approach to Cognitive Impairment After SepsiS

This study will use systems biology techniques, especially RNA-seq, to understand cognitive impairment after sepsis requiring an intensive care unit (ICU) admission.


Eligibility Criteria:
Inclusion Criteria

- Either SEPSIS or SEPTIC SHOCK

A. SEPSIS:

PRESENCE OF

1. Suspected or confirmed infection AND
2. Organ dysfunction as defined by a SOFA \>= 2 above baseline (if no baseline data available, SOFA assumed to be 0)

OR

B. SEPTIC SHOCK:

AFTER INTRAVENOUS INFUSION OF 20ML/KG CRYSTALLOID OR EQUIVALENT, PRESENCE OF

1. Suspected or confirmed infection AND
2. Lactate \> 2 mmol/L AND
3. Receiving vasopressors

Enrollment within 48 hours of ICU admission.

Must live within 200 miles of Intermountain Medical Center

Subject is at least 18 years of age or older

Must speak English

Exclusion Criteria:

* Onset of sepsis or septic shock \>24 hours after hospital admission
* Patients transferred from another hospital except for directly from an emergency room
* Patients transferred to the ICU \>48 hours after admission to Intermountain Medical Center (must have been admitted with diagnosis of sepsis)
* Prior traumatic brain injury, stroke, or intracranial hemorrhage
* DNR/DNI order before study enrollment
* Primary diagnosis of stroke or intracranial hemorrhage
* Known preexisting dementia or substantial cognitive impairment of any cause (established from both chart review, report and/or score ≥3 on IQ Code screening.
* Prior cardiac surgery (coronary artery bypass grafting or surgical valve replacement or repair)
* Known schizophrenia or other psychotic thought disorder
* Known pregnancy
* Primary diagnosis of drug overdose
* Attending physician deems aggressive care unsuitable
* Enrolled in another study if that study involves drug interventions
* Not expected to survive 48 hours
* Has a terminal condition independent of the acute illness that is expected to lead to death within 6 months
T-cell Receptor α/β Depleted Donor Lymphocyte Infusion

This pilot study is being conducted to treat patients who have a certain type of malignancy (lymphoid or myeloid) with immune effector cells after a T-cell depleted allogeneic hematopoietic cell transplantation (TCD HSCT).

This study is designed to see whether an investigational cellular product of immune cells obtained from a donor's cells that have been treated so that the type of cells that can lead to graft vs host disease have been removed can be safely administered. These cell products are administered following the initial stem cell transplant to assess the effect and improvement on minimal residual disease status, infectious complication, progression-free and overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hematologic malignancies that are candidates CD34+ selected, T-cell depleted allogeneic hematopoietic stem cell transplantation.
* Patients must have a Karnofsky (adult) Performance Status of at least 70%.
* Patients must have adequate organ function measured by:

  * Cardiac: asymptomatic or if symptomatic then left ventricular ejection fraction (LVEF) at rest must be 50% and must improve with exercise.
  * Hepatic: \< 3x upper limit of normal (ULN) AST and \< 1.5 mg/dL total serum bilirubin, unless there is congenital benign hyperbilirubinemia. Patients with higher bilirubin levels due to causes other than active liver disease is also eligible with Pl approval (e.g., patients with PNH, Gilbert's disease or other hemolytic disorders).
  * Renal: serum creatinine: ≤ 1.2 mg/dL or if serum creatinine is outside the normal range, then creatinine clearance (CrCl) \> 40 mL/min (measured or calculated/estimated).
  * Pulmonary: asymptomatic or if symptomatic, diffusing capacity of the lungs for carbon monoxide (DLCO) 50% of predicted (corrected for hemoglobin).
* Each patient must be willing to participate as a research subject and must sign an informed consent form.

Exclusion Criteria:

* Patients with active acute GvHD.