cyrilzakka/clinical-trials huggingface dataset:
Sex Differences in Risk for Alcohol Abuse

This study will determine the neural and hormonal mechanisms underlying sex differences in sensitivity to the disinhibiting effects of alcohol in heavy drinkers.

Alcohol abuse inflicts enormous physical, emotional, and financial burdens on the individual and society at large. Knowing who is at risk for alcohol abuse, and why, is crucial for the development of effective prevention and treatment strategies. Alcohol abuse has been traditionally considered a male-oriented problem and as a consequence research on risk factors specific to women has been minimal. However, the sex gap in substance abuse is closing rapidly, and findings from both animal and human studies suggest that females are actually more vulnerable to drug use than males. As such, there is an urgent need to identify sex differences in risk factors for alcohol abuse in order to develop sex-specific prevention and treatment efforts. One clear candidate risk factor is poor inhibitory control, both in terms of baseline levels of inhibition and sensitivity to the disinhibiting effects of alcohol. Recent studies suggest that sex hormones affect inhibitory control in drug-free individuals, potentially contributing to sex differences in baseline levels of inhibition. However, the degree to which fluctuations in sex hormones influence sex differences in inhibition-related brain function in sober and intoxicated individuals is not known. The proposed project will determine the neural and hormonal mechanisms underlying sex differences in sensitivity to the disinhibiting effects of alcohol in heavy drinkers.

The overall objective of the research is to identify hormonal determinants of alcohol effects on brain activation during response inhibition (BARI) in young adult female and male drinkers. BARI will be assessed using functional magnetic resonance imaging (fMRI) during performance of the stop signal task. This task reliably activates right-lateralized prefrontal regions implicated in inhibitory control. This study will assess BARI during IV alcohol (60mg%) and saline infusion in women during the early follicular and mid-luteal phases and in men at matched intervals.

Eligibility Criteria:
Inclusion Criteria:

* heavy drinking
* Alcohol Use Disorder Identification Test score above 7
* right-handed
* BMI between 19 and 26
* high school education
* fluent in English
* women must have regular menstrual cycles
* not using hormonal contraceptives

Exclusion Criteria:

* drug use disorder (SCID, DSM-5), other than nicotine or caffeine
* meets withdrawal criteria
* history of physical or psychiatric disease
* contraindication for fMRI
* pregnant or breastfeeding
* smoking more than 5 cigarettes per day
Study of the Genome, Gut Metagenome and Lifestyle of Patients With Incident Type 2 Diabetes Mellitus

A case-control study to identify microbiome and genetic differences between healthy people and patients with incident type 2 diabetes mellitus.

Two groups of people, one composed of healthy volunteers and the other of patients with incident type 2 diabetes mellitus who never received treatment for their condition, fill in the food frequency questionnaire and the physical activity questionnaire. DNA microarray genotyping is used to process the DNA samples of the participants. The data on the composition of the participants' gut microbiota is obtained through sequencing of their stool samples.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of incident type 2 diabetes mellitus

Exclusion Criteria:

* Hypoglycaemic therapy prescribed for the correction of any type of hyperglycaemia
* Diabetic ketoacidosis
* Inflammatory bowel diseases (ulcerative colitis, Crohn's disease, coeliac disease)
* Rheumatoid arthritis
* Tuberculosis
* Acute gastrointestinal conditions
* Irritable bowel syndrome
* Multiple intestinal polyposis
* Gallstone disease
* Acute pancreatitis
* Oncological diseases
* Serious mental disorders
* Recent (\< 6 months) antimicrobial therapy
* Recent (\< 3 months) proton pump inhibitors therapy
* Recent (\< 3 months) surgical intervention
* Recent (\< 3 weeks) use of probiotics, prebiotics, antacids, nonsteroidal anti-inflammatory drugs
* Pregnancy or breastfeeding
* Current alcohol/drug abuse or addiction within 12 months prior to screening
* Planned relocation from the study area during the study
* Other somatic pathologies or any factors that prevent the inclusion in the study
Clinical Evaluation of White Spot Lesions Treated by S-PRG Material and Composite Sealants in Comparison With ICON

Dental caries is the primary cause of tooth loss and oral diseases. Dental decay is a continuous pathological process with loss of tooth minerals, demineralization, which involves the destruction of tooth structure from acids. The first sign of early active demineralization is white spot lesions (WSLs) on the tooth surface, meanwhile, subsurface active mineral decomposition.

Deposition of minerals depends on the equilibrium between demineralization and remineralization which may happen as a natural repair mechanism. The aim of this trial is to comparatively evaluate the efficacy of surface pre-reacted glass filler (S-PRG) Barrier Coat coating material against the Icon resin infiltration in the ability to improve the caries lesion state of the WSLs along 1 year. Laser fluorescence was used to compare the two materials to evaluate the caries progression. PRG Barrier Coat group showed immediate significant improvement in LF scores in demineralization progress and inhibition of caries progression with a significant improved effect. S-PRG Barrier Coat was clinically successful strategy in inhibition of caries and improve remineralization.

Eligibility Criteria:
Inclusion Criteria:

* Patients within 20-40 years of age.
* Each patient has 4 or more WSLs.
* Mild and moderate WSLs according to Gorelick's scale.
* Good oral hygiene and willing patients who can attend the study visits.
* a Symmetrical number of permanent teeth in each arch (mesial to second molars).

Exclusion Criteria:

* Active carious lesions.
* Facial surface restorations.
* Intrinsic and extrinsic stains.
* Patients who have a significant medical history or if they smoke.
* Criteria for discontinuation; Mortality and acquiring severe debilitating disease
The Long QT Syndrome in Pregnancy

Long QT Syndrome (LQTS) is a disease of young adults and can affect women of child bearing age. Suffers of LQTS are at risk of ventricular dysrhythmias including torsades de pointes and ventricular fibrillation.

Pregnancy increases the chance that any mother may have an abnormal heart rhythm or arrhythmia. This chance is higher with the LQTS. There are only a few reported cases of women with the LQTS having a baby in the medical literature. This can make it difficult for the doctor caring for a pregnant woman with the long QT syndrome - especially should they need an anesthetic.

We would like to study as many women who have had a baby who have the long QT syndrome to give us a better idea of whether there are any arrhythmias occurring at the time of delivery.

This will be a retrospective analysis of all LQTS women managed at St. Paul's or BC Women's who have been pregnant in the last 5 years. These two hospitals both have a provincial role in the care of pregnant women, BC Women's as the designated provincial tertiary maternity care referral centre, and St. Paul's through its provincial PATCH clinic. Using the data from these two centres should capture the majority of LQTS cases in parturients in the province. We will search for these women from the Department of Anesthesia BC Women's consult database, the St. Paul's Cardiac Obstetrical Care database, and BC Women's Health Records using International Classification of Diseases - 10 coding for long QT. Then, after obtaining patient consent, review the charts collecting data using the data entry form. The cases will then be compared and any conclusions into the different anesthetic managements made.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with diagnoses of Long QT Syndrome, Romano Ward and Jervell - Lange Nielson Syndrome who delivered at BC Women's Hospital or St Paul's Hospital.

Exclusion Criteria:

* Non consent to participation in the study
* Age less than 19
* Non English speaker
The DREAM Study: A Multidimensional Sleep Health Intervention for Reducing Cardiometabolic Health Inequities

The purpose of this randomized controlled trial is to evaluate the impact of a multidimensional sleep health promotion intervention on blood pressure, glycemic control indicators, anthropometric markers of adiposity, and lifestyle factors in Hispanic/Latina/o/x adults. Participants will be randomized into an intervention or a control group. The control arm will receive standard Life's Essential 8 cardiovascular health educational materials. The intervention arm will additionally receive a multi-component intervention aimed at improving sleep health based on evidence-based sleep hygiene education and established behavior change techniques that include personalized sleep health feedback, goal setting and establishing a sleep health plan, coaching, self-monitoring, and addressing light and noise in the sleep environment. Mixed methods will be used to understand implementation determinants, processes, and outcomes, ensuring the successful completion and future expansion of this intervention.

Improving multiple domains of cardiometabolic health through contextual behavioral interventions can have far-reaching effects for reducing the disparate burden of multiple cardiometabolic morbidities in the Hispanic/Latina/o/x population. Despite a strong evidence base supporting the role of sleep as a major contributor to cardiometabolic health preservation, most lifestyle interventions have targeted diet or physical activity and not sleep. Sleep is amenable to intervention and can improve cardiometabolic health through complementary or synergistic biologic pathways with other lifestyle factors. Sleep health inequities have been shown to account for a large portion of racial and ethnic disparities in cardiometabolic risk. Therefore, culturally adapted sleep health interventions may elucidate scalable and sustainable contextual behavioral approaches to improve cardiometabolic health and extend healthspan.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 30-65 years
* Hispanic/Latina/o/x ethnicity
* English or Spanish speaking
* Systolic blood pressure greater than or equal to 120 mmHg
* Sub-optimal sleep health
* No history of overt cardiovascular disease
* No history of cancer

Exclusion Criteria:

* Optimal sleep health
* History of cardiovascular disease or cancer
* Non-English or non-Spanish speaking
* Not cognitively able to complete study requirements
* Severe psychiatric disorders
* Inability to provide informed consent
Immune Homeostasis in Sepsis and Septic Shock

Detailed description of immune response and its dynamics in sepsis and septic shock patiens by means of transcriptomics, flow-cytometry and cytokine analysis.


Eligibility Criteria:
Inclusion Criteria:

* sepsis/septic shock (SEPSIS-3)
* age ≥18
* informed consent
* inclusion within first 24hrs after development/diagnosis of septic shock

Exclusion Criteria:

* disagreement of the patient or legal representative with the entry into the study
* patients with primary or secondary immunodeficiency
* presence of active haematological malignancy or an active non-haematological malignancy
Interventional Validation of an MDS-Specific Measure of Quality of Life: Assessing the Responsiveness of the Quality of Life in Myelodysplasia Scale (QUALMS-1) to Different Hypomethylating Agent Regimens for Low and Intermediate Risk Disease

The goal of this research study is to test a quality-of-life questionnaire called QUALMS-1 in patients with MDS.

This is an investigational study.

Up to 240 participants will be enrolled in this multicenter study. Up to 175 will take part at MD Anderson.

If you agree to take part in this study, you will be asked to complete questionnaires twice during your participation in the 2014-0112 study.

During your first treatment visit, you will be asked to complete the QUALMS-1 questionnaire and another questionnaire that asks about your well-being.

After your 4th cycle of treatment or when you stop receiving treatment, you will be asked to complete the QUALMS-1 questionnaire again and another questionnaire to rate any changes in your health since you started the study.

It should take about 20 minutes total to complete the questionnaires each time.

Information will also be collected from your medical record. This information will include the results of lab tests and other information relating to your health.

Length of Study Participation:

After you complete the questionnaires the second time, your participation in this study will be complete.

Eligibility Criteria:
Inclusion Criteria:

1. Sign an Institutional Review Board (IRB)-approved informed consent document.
2. Age greater than or equal to 18 years
3. de novo or secondary International Prognostic Scoring Status (IPSS) low- or intermediate-1-risk MDS, including Chronic Myelomonocytic Leukemia (CMML)-1
4. Eastern Cooperative Oncology Group (ECOG) performance status of greater than or equal to 3 at study entry
5. Organ function as defined below: Serum creatine greater than or equal to mg/dL x upper limit of normal (ULN); Total bilirubin greater than or equal to 2 x ULN; Alanine transaminase (ALT; Serum glutamic pyruvic transaminase=SGPT) greater than or equal to 2 x ULN
6. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and will also need to use contraceptives. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.

Exclusion Criteria:

1. Breast feeding females
2. Prior therapy with decitabine or azacitidine
3. Prior participation in the development of the QUALMS-1 (Dana-Farber Cancer Institute=DFCI)
4. Non-English speaking patients
Effectiveness of Domperidone to Increase Breastmilk Supply in Mothers With Low Supply

This study is testing if a medication called domperidone will help women produce more milk so that they can keep breastfeeding and not use formula. The study is also testing what dose of domperidone works best to increase breast milk production.

Breastfeeding alone, until an infant is 6 months of age, is the best form of infant nutrition. There are many ways to help women breastfeed when they are having difficulties with the process, mostly involving support from a lactation consultant. However, some women, despite all appropriate non-medical interventions and support do not produce sufficient breast milk to meet the nutritional needs of their infant.

This is a feasibility study to determine how domperidone affects breast milk production in women with insufficient milk supply feeding term infants. This project will serve to refine and advance the design of a subsequent full-scale clinical trial.

The goal of this study is to: a) refine the intervention strategy (drug dosage), b) to define the target population and ensure adequate enrollment, c) assess protocol adherence and subject retention, and d) collect preliminary data to establish measures of clinical efficacy.

Eligibility Criteria:
Inclusion Criteria:

Women

* healthy women
* inadequate milk supply
* read/speak English

Infants

* healthy term infants (≥ 38 weeks gestational age)
* age ≥ 2wks and ≤3mths
* surpassed birth weight

Exclusion Criteria:

Mother

* cardiac anomalies
* breast or endocrine abnormalities (i.e. breast CA, pituitary adenomas)
* medications contraindicated with domperidone use
* drug or alcohol use
* use of hormonal contraception

Infant

* physical anomalies making breastfeeding difficult (i.e. cleft palate)
* cardiac anomalies
Optimizing the Management of Flares in Patients With Rheumatoid Arthritis (RA)

The purpose of this study is to determine how best to monitor for flares in patients with rheumatoid arthritis (RA).

This project is aimed at developing an improved multilevel care process model for the management of rheumatoid arthritis (RA) disease activity by implementing systematic self-monitoring of flare experiences by RA patients, combined with continuous patient-tailored adjustments of treatment modalities by a coordinated team of rheumatology health care providers (RHCPs).

Eligibility Criteria:
Inclusion Criteria

* Patient must be ≥ 18 years of age.
* Patient must have been seen by a rheumatology health care provider at least two times within the last 18 months at Mayo Clinic Rochester.
* Patient must have rheumatoid arthritis (RA) according to the 2010 ACR/EULAR classification criteria.
* Patient must have the ability to understand and the willingness to sign a written informed consent document.
* Patient must be willing to return to Mayo Clinic Rochester for follow-up appointments and fill out questionnaires as outlined in the study.
A Multidimensional Strategy to Improve Quality of Life of Patients With Multiple Symptoms and Palliative Care Needs

A nationwide, cross-sectional study, to determine the prevalence of symptoms of patients in the palliative phase in various care settings will be performed within a set period of two weeks in September 2018 and two weeks in November 2018. The participating settings will be selected by a total of seven coordinators, one for each consortium of palliative care in the Netherlands. To identify common combinations of symptoms and for multidimensional screening the Utrecht Symptom Diary-4 Dimensional (USD-4D) and Utrecht Symptom Diary (USD), a Dutch instrument based on the Edmonton Symptom Assessment Scale, will be used. The current protocol focuses on the cross-sectional study.

The Utrecht Symptom Diary-4 dimensional (USD-4D), a Dutch instrument based on the Edmonton Symptom Assessment Scale, will be used for multidimensional screening and assessment of intensity and prevalence of symptoms. The questionnaire assesses twelve symptoms: pain, sleeping problems, dry mouth, dysphagia, anorexia, constipation, nausea, dyspnoea, fatigue, anxiety, depressed mood and confusion. This is measured on a numeric scale from 0 (no complaints) to 10 (worst imaginable or intolerable).

The prevalence of symptoms will be described by frequencies, dichotomizing symptom scores in absent (0 on NRS) or present (1 or higher on NRS). Symptom scores of 4 or higher on NRS are considered clinically relevant.

There is a possibility to add two more complaints not enlisted and to prioritise the problems which should be addressed first by the HCP.

Quality of life is assessed using a (un)well-being measure and the opportunity to score the experienced value of life.

Finally, five multidimensional questions will screen for mental capacity ("draagkracht"), the relationship with loved ones and thoughts concerning end of life. These multidimensional questions will be filled out together with the HCP. Therefore the HCP decides beforehand whether those questions will be asked.

The USD-4D will be filled out only once by participating patients without follow-up. The patients will be asked to fill out the following characteristics: age, gender, education level, cultural background, living situation, underlying disease, comorbidities, performance score, medication groups and interventions.

The estimated time to fill out both questionnaires is fifteen to twenty-five minutes.

Eligibility Criteria:
Patient selection will be performed by health care providers in the participating settings.

Inclusion Criterium:

• Patients of whom the health care professional answers "no" to the question "Would I be surprised if this patient died in the next 12 months ?".

Exclusion Criterium:

•Patients unable or unwilling to self-assess their symptoms
Support Tool for Families of High-Risk Children With Heart Disease During Hospital Admission and After Discharge

The goal of this study is to pilot the "support tool" in the Nemours Cardiac Center to assess acceptability and feasibility. This tool will be offered to 5 high-risk families, and they will be asked to complete a survey. In addition, healthcare providers including bed-side nurses and cardiologists will be asked to complete a survey to assess the feasibility of the tool.

Despite advances in the care of children with heart disease, those affected often remain in need of complex care after hospital discharge. Multiple medications, tube feeds, and medical equipment are a few of the care needs parents face upon leaving the hospital. Unsurprisingly, many parents report problems in the transition of care from the hospital to the home. Clinical providers express frustration related to challenges with family education and communication around the time of discharge. Research is required to identify intervention strategies to improve parent/ caregiver confidence with caring for their child after discharge and reduce unintended resource utilization after discharge including clinical deterioration, unplanned 30-day readmissions, emergency department (ED) visits and nonadherence to outpatient appointments.

In Aim 1 of the study, the investigators identified the modifiable barriers, perceived needs, and opportunities for intervention to support parents/ caregivers in meeting the care needs of the high-risk child with heart disease after discharge by conducting semi-structured qualitative interviews with parents/ caregivers and healthcare personnel. And based on participants' responses, the investigators developed a support tool to improve parent/ caregiver comfort with caring for the high-risk child and improve post discharge outcomes. The objective of this study is to pilot this support tool in 5 high-risk families in Nemours Cardiac Center and assess the acceptability and feasibility based on their experience.

Eligibility Criteria:
Parent/Caregiver Group-

Inclusion Criteria:

• Parents of a child with congenital heart disease and planned discharge from the Nemours Cardiac Center.

Exclusion Criteria:

• Non-English and Non-Spanish speaking families.

The Healthcare providers group is pre-identified and they will be invited to provide feedback through semi-structured qualitative interviews only. They will not receive any intervention. Their participation will be voluntary.
A Modeling of Changes in Tidal Volume With Concentration of Inhalational Anesthetics

modelling of tidal volume with inhalational anesthetic concentration

The investigators would like to develop the modelling of tidal volume with inhalational anesthetic concentration during spontaneous breathing during general anesthesia in children

Eligibility Criteria:
Inclusion Criteria:

- general anesthesia

Exclusion Criteria:

-