cyrilzakka/clinical-trials huggingface dataset:
IT to Support Integration of Social Determinant of Health Services to Reduce Avoidable Emergency Department Visits

Working through regional Accountable Care Organizations (ACO) the sponsor will establish a 2-year pilot project to demonstrate that early recognition and intervention in the various Social Determinant of Health (SDoH) domains can reduce avoidable Emergency Department (ED) visits by high utilizers. The regional ACO's will contract with Medicaid Managed Care Plans to assign traditional high ED utilizing members to the pilot project. Members will be offered enhanced peer facilitated care management services connecting members with available SDoH community based services. Members fitting our eligibility criteria will self-select by way of completing a pilot project consent form.

The project employs a two level intervention to include Peer Support Specialist (PSS) and Community Health Advocate (CHA). Contact and engagement with participating members will be through both direct intervention in the emergency department by Peer Support Specialist (the peer) as well as in the community for prevention visits and follow up by both the peer and Community Health Advocate. These well-positioned Peers and Community Health Advocates will address Behavioral and Social Determinants of Health (SDoH) concerns through a highly coordinated intervention supported by a common IT Medicaid member tracking platform. This research project will determine the feasibility of deploying a single shared IT platform that will include referral, appointment completion, and intervention outcome data. Project staff will develop a trusting relationship with the members and will improve member access and engagement with community-based services. The project will also seek to determine the impact on total cost of care through redirecting study participants to community resources that are more appropriate, and less expensive than return visits to the emergency department.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 to 65
* New York State Medicaid Managed Care Members
* Have utilized emergency department services 6 or more times in a 12-month period
* Have been assigned to the Pilot Project by their Medicaid Managed Care Plan

Exclusion Criteria:

* Individuals not assigned by a Managed Care Organization meeting the above criteria
Residual Inflammation and Plaque Progression Long-term Evaluation

Inflammation drives atherosclerotic plaque rupture triggering most acute coronary syndromes. Despite advances in diagnosis and management of atherosclerosis, patients with myocardial infarction (MI) remain at increased risk of recurrent events. The RIPPLE study aims to examine the relationship between residual coronary inflammation detected by 68Ga-DOTATATE PET in patients treated for MI to long-term plaque progression measured by CT coronary angiography (CTCA). The association between infarct-related myocardial 68Ga-DOTATATE PET and myocardial function and viability will also be assessed.

While vascular inflammation can be detected using 18F-FDG PET, this method lacks inflammatory cell specificity and is unreliable for coronary imaging because of high background signals from the myocardium. Upregulation of somatostatin receptor subtype-2 (SST2) occurs in activated macrophages, offering a novel inflammation imaging target. 68Ga-DOTATATE, an SST2 PET tracer with low myocardial binding, shows promise for imaging coronary inflammation. Having previously demonstrated increased 68Ga-DOTATATE signals in coronary atherosclerotic lesions post-MI, we now aim to study the natural history of residual arterial inflammation in non-culprit arteries and better understand how 68Ga-DOTATATE signals relate to plaque morphology, progression and rupture. Residual infarct-related myocardial inflammation and its association with ischemic myocardial remodelling will also be examined.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants \>18 years old
* Able to give written, informed consent and to lie flat
* First-presentation of myocardial infarction within \~2 weeks
* At least mild non-culprit coronary artery disease on angiography, managed medically

Exclusion Criteria:

* Women of child bearing potential not using adequate contraception
* Contrast allergy or contrast-nephropathy
* Uncontrolled atrial fibrillation
* Chronic kidney disease (eGFR \<30 mL/min/1.73 m2)
* Any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study
* Uncontrolled chronic inflammatory disorder
* History of recent malignancy deemed relevant to the study by the investigator
* Current use of systemic corticosteroids
* Previous coronary artery bypass grafting surgery (CABG) or percutaneous coronary intervention (PCI) before the index event
* Contraindication to coronary angiography
* Requires CABG or staged non-culprit artery PCI
mDASHNa-CC APP to Support a Healthy Diet and Hypertension Control for Chinese Canadian Seniors

The aim of this proposed study is to translate the Dietary Approach to Stop Hypertension with Sodium (Na) Reduction for Chinese Canadian (DASHNa-CC), a classroom-based antihypertensive dietary educational intervention, to an innovative smartphone app (mDASHNa-CC) to enable Chinese Canadian seniors' access to this antihypertensive dietary intervention anytime, regardless of where they are.


Eligibility Criteria:
Inclusion Criteria:

* have a systolic blood pressure higher than 140 mmHg, or a diastolic blood pressure higher than 90mmHg, or are on antihypertensive medications, based on pre-intervention baseline assessment
* are able to understand (listen) and speak in Mandarin or Cantonese, read and write in Chinese
* have access to a smartphone

Exclusion Criteria:

* have special dietary requirements
* are a household member of another mDASHNa-CC participant
* plan to leave the area prior to the anticipated end of study
Child and Family Outcomes and Consumer Satisfaction for Online vs Staff-Delivered Parenting Intervention

This trial addresses a serious and all-too-frequent public health problem, namely early-onset disruptive behavior problems in young children. The focus is on testing an online treatment program which empowers parents to help their children to improve their mental health and behavioral functioning. At the conclusion of the study, the investigators will know whether the online-delivered program works as well as an established staff-delivered program, with respect to child disruptive behavior problems, parenting, parent/family stress, consumer satisfaction, and value analysis.

High-prevalence mental health problems require innovative strategies to broaden reach of evidence-based services. Disruptive behavior problems (DBPs), or conduct problems, in young children represent a major public health challenge that is not only highly prevalent but also, left untreated, heighten risk for adverse mental health and developmental outcomes in adolescence and adulthood. Internet and online technology has considerable potential to help achieve such a goal. Building on parenting interventions that have demonstrated impact on childhood DBPs, this clinical trial compares an online-delivered intervention to a well-validated staff-delivered intervention, holding program content constant. Both interventions are based on the Triple P-Positive Parenting Program. The sample includes families with a 3-7 year old child who has a pronounced level of DBPs. The study makes use of a non-inferiority trial design to determine whether the online-delivered intervention yields as good outcomes as the well-established staff-delivered intervention with respect to childhood DBPs, parenting, and parent/family stress. The study also includes a value analysis comparing the two interventions, accounting for provider and participant expenses as well as pre-implementation and implementation phases. This study is intended to shed light on the impact and potential benefits of a viable online parenting intervention for childhood disruptive behavior problems, but the results from this study are also intended to help the mental health field to better understand more broadly the potential advantages and disadvantages of online interventions over traditionally delivered interventions, particularly in light of expense minimization/effectiveness analysis.

Eligibility Criteria:
Inclusion Criteria:

* clinically elevated level of child disruptive behavior problems
* parent resides with the child and has primary custody
* parent has access to internet via computer, e-tablet, or smartphone

Exclusion Criteria:

* already in a family-based treatment
* child has pervasive developmental disorder
* parent under 20 years of age
* parent has serious mental illness
Clinical Evaluation of PET-CT for Staging of Colorectal Lung Metastases

Surgery has been available for the treatment of pulmonary metastases in metastatic colorectal cancer and promising overall survival was observed in retrospective studies with selected patients. This study investigated whether the preoperative FDG- PET/CT scan influences survival in this patient group. Furthermore, we tried to identify other prognostic factors associated with overall survival and progression-free survival.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years with pulmonary metastases eligible for pulmonary metastasectomy

Exclusion Criteria:

* Second primary cancer within the last 2 years (exception basal cell carcinoma of the skin)
* Pregnancy,
* Drug addiction,
* Renal dialysis
A Study of Oral Minoxidil to Treat Hair Loss in Children, Teens, and Young Adults Who Are Cancer Survivors

This study will test whether minoxidil taken by mouth (oral minoxidil) can improve hair loss caused by cancer treatment in children and young adults. In addition, the researchers will test the safety of oral minoxidil, and see if the study drug causes few or mild side effects in participants. Other purposes of this study include looking at whether participants are able to follow their study drug dosing schedules, and how oral minoxidil affects participants' quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have been diagnosed with cancer before the age of 17.
* They must have completed either systemic or radiation therapy (cytotoxic chemotherapy and external beam radiation therapy) for their cancer at least 1 year prior to study entry.
* They must be between 6-18 years old at the time of enrollment.
* They must have a clinical diagnosis of persistent or late alopecia for \>6 months and that is definitely, probably, or possibly related to prior chemotherapy and/or radiation.

Exclusion Criteria:

* Had a history of alopecia prior to systemic or radiation therapy for cancer, or has alopecia unrelated to cancer treatment.
* Have scalp disorders that preclude the evaluation of alopecia, such as psoriasis
* Has a known hypersensitivity to minoxidil
* Concurrent use of other therapies for alopecia
* Concurrent active anticancer therapies (cytotoxic, targeted, endocrine, immunologic)
* History of chronic sclerotic cutaneous GvHD affecting the scalp
* Active chronic cutaneous GvHD
* History of orthostatic or symptomatic hypotension, syncope related to hypotension; systolic less than or equal than 100 (for adults) and 90 (for children) at screening.
* Pregnancy.
* Cardiovascular disease that in the opinion of the cardiologist makes the patient unsuitable for therapy
* Blood pressure less than the 5th percentile or less than 90/50 mmHg for children 10 years or older
Comparison of 6% Hydroxyethyl Starch 130/0.4 With 5% Albumin as Priming Solution for Cardiopulmonary Bypass

Comparison of 6% hydroxyethyl starch 130/0.4 with 5% albumin as priming solution for cardiopulmonary bypass


Eligibility Criteria:
Inclusion Criteria:

* Mitral valvular heart disease

Exclusion Criteria:

* Status of Infection
* Re-operation
* Liver failure
* Renal disease
* Administration of steroid
Insulin Therapy and Lipoproteins' Profile in Type 1 Diabetes.

The aim of the study is to evaluate the effect of insulin therapy in patients with newly diagnosed type 1 diabetes on quantitative and qualitative changes of plasma lipoproteins, with particular emphasis on HDL metabolism, and analysis of the factors determining the effect of insulin therapy on lipid profile.The study is planned to cover a minimum of 100 people with newly diagnosed type 1 diabetes and lead prospective observation of this group (for a minimum of 5-10 years). Patients will be assessed: during the first hospitalization in the moment of diagnosis (prior to introduction of insulin treatment), after 3 weeks, after 6 months and after 12 months of insulin therapy. Further observations planned in the annual intervals. In addition, the study group will be under constant monitoring of metabolic evaluation every three months in the Outpatient Clinic.

During each follow-up will be assessed parameters evaluating the metabolism of plasma lipoprotein fractions and subfractions of HDL:

1. The concentration of apolipoprotein: including A-I, A-II, A-IV, C (II and III), D and E
2. Electrophoresis of plasma lipoproteins
3. Electrophoresis of HDL
4. The activity of enzymes: acyltransferase lecithin: cholesterol (LCAT) and plasma lipoprotein lipase Moreover, evaluation of factors which may potentially modify the relation between insulin therapy and lipoproteins will be assessed

   1. Anthropometric data and markers of insulin resistance (such as BMI, waist-hip ratio, the estimated rate of glucose distribution, VAI index, body fat, blood pressure),
   2. Metabolic management of diabetes,,
   3. Protein glycation end products
   4. The concentration of plasma adipokines.

Expected impact of the research project on the development of science, civilization and society The obtained results allow to assess the impact of exogenous insulin on quantitative and qualitative changes and metabolism of lipoproteins in the serum of patients with type 1 diabetes. Understanding the etiopathogenesis of this phenomenon and the factors affecting it seem to be very important in the treatment of patients with type 1 diabetes, where insulin is the treatment of choice and dosage adjustment appears to be extremely important. Remains unknown whether the changes in the lipoprotein profile result from the beginning of insulin therapy or other factors influence it. Selecting a group of patients with less favorable lipoprotein profile may allow better metabolic control, and thus will affect the quality and length of life of our patients. These studies will assess the impact of our therapeutic actions on the diagnosis of the disease on long-term consequences, such as the development of chronic complications.


Eligibility Criteria:
Inclusion Criteria:

* New onset type 1 diabetes and treatment with insulin.
* Written consent to participate in the study.
* There are no other medical conditions, and with no other additional drugs beyond insulin

Exclusion Criteria:

* any other medical conditions, and any other additional drugs beyond insulin
Adolescent Depression Associated With Parental Depression

Depression is difficult to identify, prevent and treat in adolescents because of complex and stigmatized multiform symptoms and pathways of care.

In children the existence of a parental depression is a significant and recognized risk factor for the development of a depression. It is regularly reported that 30% of adolescents of depressed parents have depression themselves. General Practitioners (GP) have significant access to the depression of adults, potentially parents of teenagers. In fact, 20% of patients in the regular active file of one GP have depression. The primary health care system could provide indirect but voluminous and unprecedented access to the identification of adolescent depression at an early stage from the encounter of depressed parents.

The difficulties of articulation between primary care (PC) and mental health devices are demonstrated. They disrupt the care pathways of adolescents detected in PC, prevention, and may even disturb early detection of depression. An organized joint between the PC and a specialized mental health service for adolescents ("Maison Des Adolescents" MDA) could promote the process of screening and preventing depression of adolescents of depressed parents encountered in PC.

In addition, if the effects of parental depression on adolescents are established, they remain complex and interactive. They vary by age and sex of the child but also the sex of the parent. A concomitant study of adolescent and parent depression will provide data to analyze the prevalence of depressed parent adolescent depression and to define risk or protection factors.

AdoDesP study is a cluster randomised trial (randomisation of the GPs) which compare a group of adolescent with PC articulated with mental health service (MDA) and an other group without articulation (routine cares).

A third group of depressed adolescents will be constituted to analyse parental depression of depressed adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Parents of groups 1 and 2 :

  * Major patient consulting his GP
  * Depressed patient
  * Parent of adolescent aged between 11 and 18 years old
* Adolescents of groups 1 and 2 :

  * Aged more than 11 and less than 18 years old
  * Parent included in the study
* Parents of group 3 :

  * Parent of depressed adolescent under care at the MDA of Marseille, included in the study and whose depression is confirmed by HSCL25 scale
* Adolescents of group 3 :

  * Aged more than 11 and less than 18 years old
  * Depressed patient
  * Under care at the MDA of Marseille since less than 1 month

Exclusion Criteria:

* Parents of groups 1, 2 and 3 :

  * Minor patient
  * Enable to give his consent
  * Patient with guardianship or curatorship
  * Non consenting patient
  * Pregnant or nursing mother
* Adolescents of groups 1 and 2 :

  * Aged \< 11 or ≥18
  * Parent whose depression isn't confirmed by HSCL25 scale
  * Non consenting adolescent
  * Pregnant or nursing mother
* Adolescent of group 3 :

  * Aged \< 11 or ≥18
  * Non depressed adolescent
  * Non consenting patient
  * Pregnant or nursing mother
A Compassionate Use (CU) Program of Odronextamab

Provide compassionate use of odronextamab


Eligibility Criteria:
Fecal Microbiota Transplantation for Health Improvement (TFM3)

Search for mechanisms of the effect of fecal transplantation on a healthy organism and various nosological forms.

Objectives of the study:

1. To select donors of fecal samples for carrying out the procedure of fecal transplantation of microbiota to patients with various nosological forms.
2. To select healthy volunteers for autologous and heterologous transfusion of feces and a group of placebo-control.
3. Create a bank of fecal samples of healthy donors;
4. Conduct a procedure for fecal microbiota transplantation for a sample of patients and healthy volunteers;
5. Analyze the efficacy of therapy with TFM on the sample of patients;
6. Analyze the effect of autologous, heterologous TFM and placebo on healthy volunteers;
7. Analyze long-term effects in patients within 6 months after the TPM.

The study is expected to include 50 patients, 35 healthy volunteers and healthy feces donors The study is scheduled to begin in May 2018, the supposed completion of the study is December 2020

Eligibility Criteria:
Inclusion Criteria:

* the age of patients - from 18 to 75 years, both sexes;
* Patients with:

  * antibiotic-associated colitis,
  * inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
  * diseases caused by C. difficile infection,
  * a syndrome of impaired intestinal absorption,
  * irritable bowel syndrome,
  * celiac disease (severe form),
  * metabolic syndrome, including diabetes mellitus type II,
  * Atopic dermatitis with damage to the mucous membrane of the colon,
  * hepatitis of various etiologies,
  * cirrhosis of the liver of various etiologies
  * pancreatitis of various etiologies,
* Absence of contraindications to gastroscopy
* informed consent of the patient for the transplant procedure

Exclusion Criteria:

* the presence of a concomitant chronic infectious or neoplastic disease in the patient
* Patients with a proven allergy to foods not excluded from the donor's diet
* absence of the patient for one or more intermediate stages of the examination.
* informed refusal to continue therapy
The Acute and Accumulative Effects of Snack Foods on Exercise Recovery

The purpose of the research is two-fold. One goal is to determine if post-exercise almond or cereal bar consumption can promote muscle gain as well as increasing muscular strength throughout an eight-week weight training program. The other goal is to assess the short-term effects of almonds or cereal bar on recovery that may explain the overall long-term adaptations.


Eligibility Criteria:
Inclusion Criteria:

* BMIs of 18.5-30 kg/m2
* participate in no more than 3 hours of structured exercise per week

Exclusion Criteria:

* weight training more than 30 min/week,
* smoking,
* use of medications known to impact inflammation,
* musculoskeletal limitations,
* use of supplements within 1 month of participation that are known to impact body composition, antioxidant or inflammatory status,
* regular consumption of more than 2 servings of nuts per week,
* unwillingness to refrain from recovery treatments during the study such as hydrotherapy, massage, stretching, compression garments, anti-inflammatory medications and topical applications.
Ten Years Follow-up After Insertion of a MUS (Mid Urethral Sling) Due to Stress Urinary Incontinence

The investigators intend to investigate the long-term complications and the subjective well-being among women who underwent insertion of a MUS due to stress urinary incontinence 2006-2010.


Eligibility Criteria:
Inclusion Criteria:

* Underwent a MUS in Sweden 2006-2010 due to stress urinary incontinence.
* Were registered in The Swedish National Quality Register of Gynecological Surgery.

Exclusion Criteria:

* Did not undergo MUS surgery in Sweden 2006-2010 due to stress urinary incontinence, except those constituting the control group.
Elimination of CO2-insufflation-induced Hypercarbia in Open Heart Surgery

The study aim was to evaluate if an additional separate venous reservoir eliminates CO2-insufflation induced hypercapnia and keeps sweep gas flow of the oxygenator constant during open heart surgery.

Background: CO2-gas insufflation is used for continuous de-airing during open heart surgery. The study aim was to evaluate if an additional separate venous reservoir eliminates CO2-insufflation induced hypercapnea and keeps sweep gas flow of the oxygenator constant.

Methods: A separate small reservoir are used during CPB in addition to a standard large venous reservoir. The small reservoir receive drained wound blood and CO2-gas continuously via a suction drain (1 L/min) and handheld suction devices from the open surgical wound. CO2-gas is insufflated via a gas-diffuser in the open surgical wound at 10 L/min. During cross-clamping, gas and blood are either continuously drained to the standard large venous reservoir or not, every 5 minutes after steady state of PaCO2 is observed, after adjustment of sweep gas flow as necessary. Mean values for each setup (2-4 times) for each patient will be analyzed with Wilcoxon rank-sum test.

Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing open heart replacement of the aortic valve
* Use of perioperative cardiopulmonary bypass

Exclusion Criteria:

* Denied participation in the study