cyrilzakka/clinical-trials huggingface dataset:
Research on Excessive Iodine Status in Pregnancy

To explore main cause and health impact of iodine excess during pregnancy, we performed iodine evaluation for 390 consecutive pregnant women from January 1st, 2016 to December 31st, 2016. Among them, 18 women (4.62%) with apparently elevated urinary iodine concentration (UIC) were enrolled onto this study for subsequent follow-up. History of high iodine exposure was collected from all participants. Parameters about iodine status were monitors until termination of pregnancy, and dietary iodine intake condition and thyroid function were also evaluated.

A prospective follow-up was arranged for the 18 pregnant women with excessive iodine status. History of iodine exposure (including hysterosalpingography (HSG) using an oil-soluble iodinated contrast medium, examination by computed tomography scan with contrast, administration of amiodarone, history of receiving radioiodine therapy, etc.) was collected from all participants. Evaluation of dietary iodine intake was performed through a 72-hour dietary recall.The serum iodine concentration (SIC) and urinary iodine concentration (UIC) were monitored continuously in the whole course of pregnancy. All subjects with excessive iodine load were recommended by nutritionists to have their dietary iodine intake restricted, and resume iodine-containing supplements and foods until the UIC\<250 μg/L and SIC≤90 μg/L. After delivery, maternal colostrum iodine concentration and neonatal iodine status (including neonatal UIC, condition of congenital hypothyroidism screening tests, and thyroid physical examination) were also assessed.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with apparently elevated urinary iodine concentration (UIC ≥250μg/L) and serum iodine concentration (SIC\>90μg/L) were enrolled in this study.

Exclusion Criteria:

* Subject who did not sign the informed consent or whose clinical date was not intact was excluded in our study.
Study of Arginine Metabolism and Nitric Oxide Formation in Relation to Glutamine Supply in Severely Burned Patients

The purpose of the study is to understand the way the body uses amino acids and proteins in burned patient during the time they cannot eat normally. This study aims to understand the metabolism of the amino acid arginine in the body after burn injury. The results of this study will help determine the best composition of food needed during an acute burn injury so that body can more efficiently use the supplied nutrient for optimal burn wound healing and early recovery.

The principle sources of plasma free arginine are (i) diet, (ii) release from protein breakdown and (iii) de novo synthesis directly from citrulline and the recycling of orthinine via the urea cycle. The major pathway of arginine disposal is i)oxidation via orthinine glutamate and subsequently the Tricarboxylic Acid (TCA) cycle and ii)via formation of nitric oxide. The latter pathway plays an important regulatory role in the body's response to stress and is significantly increased after burn injury.

Previous studies with burn patients show i)an increased rate of total arginine flux, ii)a limited rate of arginine de novo synthesis, and iii) an apparent increase in the rate of arginine catabolism as measured indirectly by increased orinthine oxidation. These changes render arginine a conditionally essential amino acid for burn patients. Studies have shown that feeding glutamine to healthy adults significantly alters the blood concentrations of urea cycle intermediates arginine, citrulline and orthinine. Therefore, we hypothesize that the availability of arginine can be improved in the burn patient by supplementing total parenteral nutrition (TPN) support with glutamine.

Using stable isotope tracer studies our specific aims are:

1. To explore the dynamic aspects of arginine and citrulline metabolism. There will be an emphasis on arginine disposal via oxidation and urea nitrogen formation via nitric oxide production.
2. To explore the effect of a) depleting arginine and its immediate precursors proline and glutamine, and b)glutamine supplementation on the metabolic pathways of burn patients.
3. To estimate the rate of nitric oxide (NO) formation in burn patients using arginine and citrulline tracers

Eligibility Criteria:
Inclusion Criteria:

* Burn patients being treated at MGH Burn Unit with one or more of the following criteria: 1) \>=5% TBSA; 2) inhalation injury; or 3) resting energy expenditure (REE) of \>15% of the predicted Basal Metabolic Rate using the Harris-Benedict equation.
* Must be receiving total parenteral nutrition in the course of their treatment.

Exclusion Criteria:

* Patients with thyroid disease
* Patients who are not hemodynamically stable or show unstable vital signs
* Patients at the stage of major organ failure, e.g. renal and/or liver failure.
Respiratory Muscle Strength in Patients With Obesity Hypoventilation Syndrome (OHS) or With a Precursor of the Disease

Using an extensive set of both volitional and non-volitional tests of respiratory muscle function and strength it is the aim of this study to

* identify potential determinants for the development of obesity hypoventilation
* to identify predictors for the presence of a sleep-related hypoventilation requiring treatment in obese patients


Eligibility Criteria:
Inclusion Criteria:

* patients with BMI \> 30 and obesity-associated hypoventilation stages I - IV
* patients with BMI \> 30 and elevated OHS-risk (= obstructive sleep apnea without hypercapnia)
* age:18-80 years
* capacity to consent

Exclusion Criteria:

* any other disease, that causes ventilatory insufficiency
* pacemaker, defibrillators or device for deep brain or vagus nerve stimulation
* esophagitis, Barrett-esophagus, esophageal cancer
* acute gastritis and ulcera ventriculi
* epilepsy
* any medical, psychological or other condition impairing the patient's ability to provide informed consent
Personalized Management of Pancreatic Adenocarcinoma Using Patient-Derived Tumoroids

This study is designed to prospectively investigate the feasibility of establishing patient-derived tumoroids (PDT) as a platform for a personalized approach for response prediction and guide optimal neoadjuvant and/or adjuvant approach. PDT will be investigated to determine drug sensitivity, predict the response to chemotherapy agents and radiation therapy, and validate this response in treated patients, and to establish the feasibility of PDT as a platform for a personalized approach to guide multimodality treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age.
* Have an ECOG Performance Status of ≤ 2.
* No evidence of distant metastasis on imaging.
* Histologic or cytologic proven adenocarcinoma of the pancreas.
* Providing informed consent prior to enrollment in the trial.

Exclusion Criteria:

* Failure to obtain additional core needle biopsies for generating PDTs.
* Females who are pregnant or plan to become pregnant.
Micro RNAs to Predict Response to Androgen Deprivation Therapy

Identify exosomal micro RNA that predict responses to ADT

1. Identify novel exosomal RNA signatures at pretreatment that predict response to ADT.

   The study team will collect blood samples from patients with systemic disease pretreatment (at enrollment), three months post-treatment and at the time of progression of disease (or at two years post-ADT for patients still in remission at that time point) and then perform next-generation sequencing using serum exosomal RNAs derived from these patients.

   The investigators plan to identify exosomal RNAs signatures that change between pretreatment (at enrollment) and during treatment (at three months) and further explore the effect of these changes on disease response. The investigators also plan to compare exosomal RNA levels between patients relapse within the first two years versus those in remission at two years. Among patients with progression, the investigators plan to compare exosomal RNA signatures at progression of disease to signatures at pretreatment and during treatment.
2. Validate exosomal RNA markers that predict response to ADT by real-time RT-PCR.

Secondary objectives: Selected RNAs, identified through the above process will be validated using real-time RT-PCR assay to test reproducibility of RNA sequencing results. The investigators expect to select and validate approximate five RNA markers that predict duration of response to ADT.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven prostate cancer.
* Testosterone level \>30ng/ml and at least 6 months since last dose of hormonal therapy.
* History/physical examination including a detailed description of the stage of prostate cancer within 8 weeks prior to registration.
* CT scan of abdomen and pelvis with IV contrast and bone scan should be performed within 8 weeks prior to registration.
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
* Age ≥ 18.
* Patients must provide study-specific informed consent prior to study entry for this project and mandatory blood specimen for banking for future studies (future studies may include genetic testing).

Exclusion Criteria:

* Received hormonal therapy less than 6 months prior to registration.
* History of active secondary malignancy.
* Decline hormone therapy for prostate cancer.
* Current or previous treatment with 5-alpha reductase inhibitors within 6 months prior to enrollment.
Blood-brain Barrier Permeability in Alzheimer's Disease

The main aim of the present study is to improve our understanding of the role of blood-brain barrier function in dementia of the Alzheimer's type. The investigators hypothesize that microvascular dysfunction - more specifically "cerebral perfusion and blood-brain barrier leakage" - is a determinant of cognitive decline and cortical atrophy in Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

Patients with AD:

* Informed consent before participation in the study
* Received standard diagnostic procedure according to the Parelsnoer Initiative procedure
* Diagnosed with dementia of the Alzheimer's type
* Clinical dementia rating (CDR) of 1, which means a mild to moderate stage of dementia
* MMSE ≥ 20 and patients are mentally competent (in general, individuals with an MMSE ≥ 18 are considered mentally competent)

Patients with prodromal AD:

* Informed consent before participation in the study
* Received standard diagnostic procedure according to the Parelsnoer Initiative procedure
* Diagnosis of prodromal dementia according to the Dubois criteria (16)
* CDR of 0.5, which suggests a very mild stage of dementia
* Memory impairment defined as Delayed Recall on Verbal Learning Test (15 WLT) \< 1.5 SD
* MMSE ≥ 20 and patients are mentally competent.
* Medial temporal lobe atrophy scale MTA ≥ 1 (17) OR abnormal levels of Aß42, t-tau or p-tau

Healthy participants:

* Informed consent before participation in the study
* No Diagnosis of dementia, prodromal dementia, or mild cognitive impairment.
* MMSE ≥ 26
* No substantial memory complaints (according to participant)
* Age, gender and education is matched to the patient groups.

Exclusion Criteria:

* Contraindications for scanning (e.g. brain surgery, cardiac pacemaker, metal implants, claustrophobia, large body tattoos)
* Contraindications for contrast agent Gadovist (renal failure) as determined by the estimated Glomular Filtration Rate eGFR \< 30 mL/min.
* Major vascular disorders (e.g. stroke, heart disease)
* Psychiatric or neurological disorders: Major depression (\< 12 months); history of schizophrenia; bipolar disorder; psychotic disorder NOS or treatment for a psychotic disorder (\< 12 mnd); cognitive impairment due to alcohol abuse; epilepsy; Parkinson's disease; MS; brain surgery; brain trauma; electroshock therapy; kidney dialysis; Meniere's disease; and brain infections.
* Structural abnormalities of the brain
* Cognitive impairment due to alcohol/drug abuse
* Absence of reliable informant (for patient groups)
Individualized Strategies of Red Blood Cell Transfusion for Perioperative Pediatric Patients

The individualized strategies of red blood cell for perioperative pediatric patients are made based on the comparison between the clinical condition score and the Hb concentration.

The hypothesis is that the individual transfusion strategies will help to save blood resource, and meanwhile will not adversely affect the patients' clinical outcomes. Participants will be randomly divided into two groups, where the strategies of transfusion of red blood cell will be made following different principles. The strategies for patients in control group will be made by the attending doctors in charge according to the current Chinese red blood cell transfusion guidelines. For the patients in study group, the clinical condition will be identified every time red blood cell transfusion is considered. The strategies will be made according to the comparison between the score and the Hb concentration. The volume of the red blood cell used in these two groups will be compared. The number of patients who need transfusion in these two groups will be compared. The clinical outcomes will also be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* The Hb concentration is tested before operation. It is higher than 7g/dl and lower than 10g/dl. Or it is anticipated that it will decrease lower than 10g/dl.

Exclusion Criteria:

* The patient will not undergo an operation.
* newborn or premature baby
* patients accompanied with hemorrhagic disease or cyanotic heart disease
* patients with ischemic heart disease or ischemic cerebrovascular disease
Public Health Nurse-Peer Co-Led Group Cognitive Behavioral Therapy for Postpartum Depression

The purpose of this study is to determine the effectiveness of an online 9-week group Cognitive Behavioural Therapy (CBT; a type of talking therapy) intervention that is co-led by public health nurses (PHNs) and individuals who have previously recovered (i.e., lay peers) from postpartum depression (PPD) for treating PPD when delivered in addition to treatment as usual (TAU) compared to TAU alone. The study will also assess the impact of the intervention on common comorbidities (anxiety) and complications (parenting stress, mother-infant relationship, social support, and infant temperament) of PPD and whether it is cost-effective.

The primary objective of the Randomized Controlled Trial (RCT) is to determine if a 9-week group Cognitive Behavioral Therapy (CBT) intervention delivered online and co-led by public health nurses (PHNs) and peers added to treatment as usual (TAU) can improve postpartum depression (PPD) more than TAU alone. Peers are individuals who have previously recovered from PPD and received training to deliver the intervention. The secondary objective of the RCT is to determine if the intervention can effectively treat its common comorbidities (anxiety) and complications (parenting stress, social support, mother-infant relationship, and infant temperament) and whether the intervention is cost-effective. 170 mothers/birthing parents will take part in the study with 50% being randomly assigned to the intervention group. All participants complete online questionnaires at 3 time points: baseline (T1), 9 weeks later (T2-immediately post-intervention in the experimental group to assess effectiveness) and 6 months later (T3-intervention durability).

Eligibility Criteria:
Inclusion Criteria:

Mothers or birthing parents, 18 years old, have an infant under 12 months of age at recruitment, fluent in written/spoken English, have a Edinburgh Postnatal Depression Scale (EPDS) score ≥10 and live in Ontario, Canada.

Exclusion Criteria:

Bipolar, psychotic, or current substance use disorders and borderline personality disorder as assessed during screening when study coordinator administers the Mini International Neuropsychiatric Interview (MINI).
Comparison of Premixed Insulins Aspart 30, Aspart 70 and Aspart on Postprandial Lipids

The aim of the study is to investigate meal-related treatment with either premixed Insulin Aspart 30, Aspart 70 and Aspart with regard to postprandial glucose, triglyceride and free fatty acids excursions after a standard breakfast and lunch.

Whereas the effects of each of the established types of insulin (remixed Insulin Aspart 30, Aspart 70 and Aspart) have been shown before, their specific glucose and lipid lowering capacities have so far not been investigated in a simulated physiological situation.

Eligibility Criteria:
Inclusion Criteria:

* Type-II Diabetes
* BMI \> 27 kg/m2
* age 35 to 75 years
* HbA1c \< 8.5%
* informed consent
* treatment with pre-mixed insulin
* stabile dose of insulin for at least 4 weeks

Exclusion Criteria:

* Type-I Diabetes mellitus
* HbA1c \> 8.5 %
* Serum Creatinine \> 1.7 mg/dl
* Alaninaminotranferase or Aspartataminotransferase \> 3x Upper Limit of Normal
* treatment with sulfonylurea or gliptins
* treatment with glitazones
* manifest clinical infections
* treatment with glucocorticoids or antipsychotic drugs
* psychiatric diseases
* alcohol abuse
* myocardial infarction or stroke within the previous 3 months
* surgery within the previous 3 months
Effects of Heating Transfusion on Brain Function

To inversitage whether routine warming of blood is harmful to brain fuction of sugical patients receiving massive transfusion.

Hypothermia is an effective therapeutic intervention to reduce hypoxic ischemia brain injury in animal experiments and in clinics.In a recent study, it has been shown that perioperative warming was associated with a higher incidence of cognitive dysfunction in elderly patients.Therefore, we hypothesised that perioperative heating transfusion have a side effect on brain function of surgical patients.

Eligibility Criteria:
Inclusion Criteria:

* adult patients scheduled for major surgery under general anesthesia and they probably need a blood transfusion during the procedure.

Exclusion Criteria:•Patients with a history of stroke, central nervous system disease , metabolic disturbance, psychiatric illness, hearing impairment, drug abuse or unwilling to participate in assessment

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Cocaine Use Reduction With Buprenorphine

The aim of this study is to investigate the safety and effectiveness of buprenorphine in the presence of naltrexone for the treatment of cocaine dependence.

This project will assess the utility of buprenorphine in the presence of naltrexone as a potential medication useful in reducing cocaine use, commencing a research direction of great importance to both theoretical and practical addiction medicine. Buprenorphine will be provided as sublingual buprenorphine+naloxone tablets (Suboxone®, "BUP"). Naltrexone will be provided as extended-release (XR) naltrexone by injection (Vivitrol®, "XR-NTX").

In this multi-center, double-blind, placebo-controlled trial, participants will randomly assigned to one of three medication conditions: 4mg buprenorphine plus naltrexone (BUP4+XR-NTX), 16mg buprenorphine plus naltrexone (BUP16+XR-NTX), or placebo plus naltrexone (PLB+XR-NTX) for 8 weeks of treatment. Participants will be scheduled for clinic visits three times weekly (for a total of 24 visits across the 8-week treatment period) for observed medication administration, provision of take-home medication, collection of safety, medical, drug use, psychological, and compliance measures. In addition, all participants will be scheduled for once-weekly individual Cognitive Behavioral Therapy (CBT) sessions.

This protocol will explore the effects of these three medication conditions to test buprenorphine as a possible treatment for cocaine dependence. This study will advance the science, provide dosing information, and characterize the effects of the combination of the two medications in this population.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age
* In good general health
* Meet Diagnostic and Statistical Manual (DSM)-IV criteria for cocaine dependence
* Meet DSM-IV criteria for past-year opioid dependence OR past-year opioid abuse OR have past-year opioid use and a history of opioid dependence during the lifetime
* Interested in receiving treatment for cocaine dependence
* Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study
* Able to satisfy and comply with study procedures and requirements
* If female of childbearing potential, willing to practice and effective method of birth control for the duration of the study

Exclusion Criteria:

* Pregnant or breastfeeding females
* Known allergy or sensitivity to study medications
* Recent or ongoing treatment with medications that, in the judgment of the study medical clinician, could interact adversely with study drugs or interfere with study participation
* Have a current pattern of alcohol, benzodiazepine, or other sedative-hypnotic use, as determined by the study medical clinician, which would preclude safe participation
* Liver function test results greater than 5 times the upper limit of normal or other exclusionary clinical lab test values
* Serious medical condition or acute psychiatric disorder that would make study participation difficult or unsafe
* Pending action or situation that might prevent remaining in the area for the duration of the study
Behavioral Economics to Implement Nutrition Ranking in Food Pantries

The goal of this randomized controlled trial is to test whether using behavioral economic strategies to promote healthy food choices on a food bank's online ordering platform increases the use of the traffic light nutrition ranking system and increases healthier food selections by the food agencies (e.g., food pantries) who use the food bank.

This study will use behavioral economic strategies to promote utilization of traffic-light nutrition ranking in the Greater Boston Food Bank (GBFB) order system to improve the dietary quality of food ordered by GBFB agencies. Supporting Wellness at Pantries (SWAP) is a program to guide both traffic light labeling for use on ordering platforms and pantry shelves, as well as food pantry layout to inform clients and encourage healthy food choice.This study is a collaboration with the Greater Boston Food Bank (GBFB) to test BE strategies (choice architecture, framing, social norms) for implementation of an evidence-based intervention (traffic light nutrition ranking, SWAP). We will determine if behavioral economic interventions on the GBFB online ordering platform increase agencies' use of traffic light nutrition labels when placing orders and increases their healthy food orders. We will conduct a 12-month randomized controlled trial comparing agencies' ordering experiences and outcomes with the current user interface (control) to a "SWAP-enhanced" user interface (intervention). All GBFB partner agencies will be randomized to see either the control or intervention interfaces when they log on to ShopGBFB, GBFB's online food ordering platform. At the end of 12 months, agency staff will complete a survey about their online ordering experiences at GBFB. In the next phase, the SWAP-enhanced ShopGBFB interface will be updated, adapted, and implemented for all 364 agencies that place orders. Agency ordering outcomes will be monitored for 12 additional months.

Eligibility Criteria:
Inclusion Criteria:

* Food agencies that order food from the Greater Boston Food Bank (GBFB) online ordering platform.

Exclusion Criteria:

* Food agencies that do not order food from the GBFB online platform within 2 months of the start of the study.