cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Nutrition Training Augmented With Digital Technology in Graduate Medical Education

Investigators will conduct a randomized controlled evaluation of standard nutrition education vs. standard education + Nutri, and interactive clinical software that automates diet assessment and guides resident physicians through personalized and evidence-based diet counseling. Investigators will evaluate differences in resident-reported diet counseling competence and self-efficacy using survey measures. Investigators will evaluate skills using a simulated patient appointment and coding scheme described in prior work.


Eligibility Criteria:
Inclusion Criteria:

* Dell Medical School Internal Medicine Residents
* Dell Medical School Family Medicine Residents

Exclusion Criteria:

* N/A
Harnessing Online Peer Education Opioid Study

The investigators have created an online peer support platform for chronic pain patients on opioid medications. This platform provides peer support and online mental health counselor run support groups to help participants manage pain and not abuse opioid medications.

This study determined the feasibility, acceptability, and preliminary efficacy of an online support and risk reduction platform to prevent opioid misuse and abuse. This is an urgent area of research; opioid misuse/abuse has reached epidemic proportions in recent years. It is linked to causing the largest drug epidemic in the history of the United States and has become the top priority of the US Surgeon General. Because the opioid crisis (including heroin use) is believed to have largely originated from chronic pain patients' opioid prescriptions, this application will initially focus on the needs of chronic pain patients on opioids who are high risk for addiction and overdose. Later versions of the technology will expand to the broader population of people affected by the opioid crisis, including heroin users.

Although low cost, novel interventions are needed to reduce opioid misuse and abuse, before they lead to addiction and fatal overdose, only 6 behavioral (non-pharmacological) randomized controlled trials have been successfully conducted in this area to date (with our group having conducted one of them), creating a tremendous need for solutions to the opioid crisis. Building off extensive preliminary research that our team conducted, including piloting technology-based behavior change interventions among chronic pain patients, and developing artificial intelligence (AI)-based prediction models of opioid outcomes, we propose to design and test the feasibility, acceptability, and preliminary efficacy of an online peer social support and clinical counseling community to reduce opioid misuse/abuse among chronic pain sufferers.

Eligibility Criteria:
Inclusion Criteria: adults over 18, COMM scores at risk of misuse, prescribed opioids by doctor -

Exclusion Criteria: cancer patients, elicit drug users, under 18 years

-
Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease

This study will assess the effects of vitamin D3 supplementation (cholecalciferol; 2000 IU daily) on serum calcium levels, circulating vitamin D levels, and markers of kidney disease and cardiovascular risk among people with diabetes mellitus and early kidney disease. Eligibility criteria include type 2 diabetes and stage 1-2 chronic kidney disease, defined by a urine albumin-creatinine ratio 30-300 mg/g and an estimated glomerular filtration rate ≥ 60 mL/min. Participants will be randomly assigned to treatment with vitamin D3 or placebo, each taken by mouth once daily for a study duration of one year. Study medications will be added to standard treatment, including an angiotensin converting enzyme inhibitor and/or angiotensin II receptor blocker. We hypothesize that vitamin D3, compared with placebo: (1) is well-tolerated and safe among people with diabetes and kidney disease; (2) results in adequate attained circulating vitamin D levels; and (3) positively affects markers of kidney disease and cardiovascular risk.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes mellitus
* Urine albumin-creatinine ratio 30-1000 mg/g
* Estimated glomerular filtration rate greater than or equal to 60 mL/min
* Treatment with angiotensin converting enzyme inhibitor and/or angiotensin II receptor blocker for greater than or equal to 6 months, with a stable dose for greater than or equal to 3 months
* Blood pressure less than 140/90 (assessed while taking medications)
* Hemoglobin A1c less than 9% (assessed while taking medications)
* 25-hydroxyvitamin D less than 30 ng/mL

Exclusion Criteria:

* Prior dialysis or kidney transplantation
* Known cause of albuminuria other than diabetes
* Planning to leave the area within 12 months
* Life expectancy less than 12 months
* Participation in another clinical trial within 6 months
* Osteoporosis or other established indication for vitamin D therapy
* Vitamin D3 supplement intake greater than 400 IU/day at screening visit
* History of nephrolithiasis
* Serum calcium greater than 10.2 mg/dL
* Dementia, not fluent in English, or unable to provide informed consent without proxy respondent
* Incontinent of urine
* Failure to take greater than or equal to 80% of placebo pills during study run-in
Sorafenib and TACE as Adjuvant Therapy for MVI in HCC Patients After Radical Resection

This study is a prospective non-randomized controlled study. The purpose of this study is to evaluate the validity and safety of sorafenib and transcatheter arterial chemoembolization (TACE) for microvascular invasion (MVI) in hepatocellular carcinoma (HCC) patients after radical surgery.

HCC is the sixth most common malignancy worldwide.Selected patients with HCC are candidates for potentially curative therapy, such as hepatic resection and liver transplantation. Nevertheless,tumor recurrence is 70 % at 5 years after resection and 15-30 % after liver transplantation,leading to tumor-related death.MVI is currently one of the most critical factors predictive of HCC recurrence.There are no approved effective interventional measures to improve the outcome of this patients with MVI.The purpose of this study is to explore the validity and safety of sorafenib and TACE for MVI in HCC patients after radical resection.The candidates will be assigned to sorafenib group (about 30 cases),TACE group (about 30 patients) and control group (about 30 cases)，according to the willingness of the subject.All patients will be followed up for 3 years and Recurrence-free survival and overall survival will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years of age;
* The liver tumor has been radically resected;
* Postoperative pathology proved to be hepatocellular carcinoma with negative margin and microvascular invasion;
* Imaging evaluations(CT/MRI) were performed at 1 month after the resection and no area of enhancement was seen;
* Child-Pugh A;
* Eastern Cooperative Oncology Group(ECOG) body condition score (PS) 0-1;
* Then patients understand and voluntarily signed a written informed consent;

Exclusion Criteria:

* Recurrent HCC;
* pathology-proved multifocal HCC or HCC with satellite nodules;
* Tumor thrombus in portal vein or inferior vena cava trunk;
* Patients with extrahepatic metastasis found by radiologic or pathologic examination;
* severe dysfunction of the heart, kidney, or other organs.The patients cannot tolerate TACE or sorafenib after general assessment of the situation;
* Enrolled in other clinical study at the same time;
* Previously treated with other antitumor treatments except the resection;
* The researchers believe that the patient does not fit this study;
* Pregnant or lactating women.
The Effectiveness of Eating Disorder Treatment

Family-based treatment (FBT), a form of family therapy for eating disorders (ED) in young patients, has proven to be effective in numerous large-scale studies. This study aims to evaluate outcomes of the treatment for anorexia nervosa (AN) in a 'real-world' setting in a specialized outpatient clinic in Helsinki, Finland. Fifty-two young female patients seen for treatment between June 2013 and December 2017 were included in the study. Demographic and treatment characteristics, weight, and ED symptoms before and after treatment are reported

Aim: The naturalistic outcome of outpatient FBT for adolescent AN was investigated.

Methods: Fifty-two female patients and their families who received FBT at a tertiary eating disorders unit participated in the study. Data on their pre-treatment parameters, treatment details, and condition at the end of treatment (EOT) was collected from their medical records

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Anorexia nervosa
* Admitted to FBT at the Eating Disorder Unit from June 1, 2013, through December 31, 2017

Exclusion Criteria:

* No exclusions
Paliperidone Extended Release in Schizophrenia Participants With Duration of Illness Less Than 10 Years

The purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (ER) in symptomatic participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) who were receiving treatment with any oral (having to do with the mouth) antipsychotic medication and who needed to be switched to paliperidone ER from the current oral antipsychotic therapy due to insufficient efficacy or due to side effects.

This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center) and non-comparative study of paliperidone ER in participants with schizophrenia who have a previous history of bad adherence to the antipsychotic treatment because of insufficient efficacy and side-effects. All the eligible participants will receive a dose of paliperidone ER in range of 3 to 12 milligram (mg) orally (taken by mouth; to be swallowed) once daily for 13 weeks. Efficacy and safety will primarily be evaluated by Positive and Negative Syndromes Scale (PANSS) and Extrapyramidal Symptom Rating Scale (ESRS), respectively. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self)
* Positive and Negative Syndrome Scale (PANSS) total score at Baseline of greater than equal to 70 and less than equal to 100
* Participants who need to be switched from the current oral antipsychotic therapy because of lack of efficacy or side effects
* Participants followed as outpatients
* Female participants must be postmenopausal for at least 1 year, surgically sterile or, if sexually active, be practicing an effective method of birth control and female participants of childbearing potential must also have a negative urine pregnancy test at Baseline

Exclusion Criteria:

* Acute psychotic relapse that requires hospitalization and first antipsychotic treatment ever
* Participants who had received clozapine during the previous 3 months
* History or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body) and neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
* Pregnant or breast-feeding female
* Participated in an investigational drug trial in the previous 30 days
WILD 5 Wellness: A 30-Day Intervention

The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition in Beloit College students. This program is called "WILD 5 Wellness: A 30-Day Intervention". Results for this study will be quantified through the use of standardized self-report questionnaires administered prior to and after students complete the WILD 5 program (Group 1) or 30 days of inactive participation (Group 2), and again approximately 30 days later when the initially inactive group (Group 2) will have just completed their active participation in the WILD 5 program and the first WILD 5 group (Group 1) will be approximately 30 days out from completion of their WILD 5 active portion. Data will be collected to evaluate participants' adherence and response to each element of WILD 5, a 5-pronged 30-day wellness intervention. It is expected that this 30-day integrated, prescriptive, and trackable program will be found to be an efficacious wellness intervention for Beloit College students as compared to the control (inactive) group of students not participating in the Active program.


Eligibility Criteria:
Inclusion Criteria:

* Beloit College student enrolled in one or more of the following Spring 2017 academic courses:
* Anthropology 201 01 "Research Designs: Sophomore Seminar in Anthropology"
* Health and Society 240 B1 "Sophomore Seminar in Health and Society"
* Spanish 218 "Health and Culture in the Spanish-Speaking World"
* Biology 373 "Neuroscience Research"
* Biology 215 "Emerging Diseases"

Exclusion Criteria:

* Individuals who are \<18 years old
* Individuals who are acutely suicidal and/or actively psychotic
* Individuals who are pregnant or plan to get pregnant during the next 60 days, or who are not registered in one of the courses listed above.
Dupilumab De-escalation in Pediatric Atopic Dermatitis

This is a pilot investigator-blinded, randomized clinical trial to assess the feasibility of dupilumab treatment discontinuation or dose-reduction in children aged 1-17 years who have achieved sustained atopic dermatitis (AD) control on dupilumab.

Participants will be randomly assigned to one of three groups: discontinuation of dupilumab; reduction of dupilumab dose; or continuation of standard dupilumab dose. During the active study treatment period, participants will be asked to complete 5 study visits. At these visits, a physician will conduct a skin examination to assess atopic dermatitis (AD) severity and participants will complete questionnaires about their AD symptoms and severity. During the observational period, participants will be asked to complete questionnaires about their AD symptoms and medication use every twelve weeks, for a total of 3 follow-up contacts. The purpose of this study is to evaluate the feasibility and sustainability of reducing or discontinuing dupilumab in children with well-controlled AD.

Eligibility Criteria:
Inclusion Criteria:

* Aged 1 to \<18 years old, either sex, any race or ethnicity
* Provide signed informed consent by parent or legal guardian and informed assent if applicable
* Has a physician confirmed diagnosis of atopic dermatitis
* Has received dupilumab for at least 12 months for the treatment of atopic dermatitis
* Has had well-controlled atopic dermatitis on dupilumab within last 6 months (defined as POEM\<=7, EASI\<=7, or IGA\<=2)
* Able to speak English
* Able and willing to adhere to all study procedures

Exclusion Criteria:

* Taking concurrent systemic medication for atopic dermatitis (e.g., methotrexate, cyclosporine, tralokinumab, abrocitinib, upadacitinib, systemic corticosteroids)
* Using concurrent phototherapy for atopic dermatitis
* Taking dupilumab for a clinical indication other than atopic dermatitis (such as asthma or eosinophilic esophagitis)
* Poor control of atopic dermatitis
* Poor control of asthma or eosinophilic esophagitis
* Has used an investigational drug within 90 days or plan to use an investigational drug during the study period
* Does not have health insurance or will lose health insurance during the study period
Team Approach to Polypharmacy Reduction to Improve Mobility Long-Term Care

Medication side effects and interactions between medications are very common in older adults and are related to negative health outcomes, including mobility. In this study, the investigators will test a new process aimed at reducing unnecessary medication use and drug side effects in seniors using the best medical evidence and patient preferences for treatment. This study will assess how feasible the implementation of this intervention is within a long-term care facility as well as if it is possible. The study will also assess for any signals of reversal of medications related mobility impairments to reduce medications-related mobility impairment (fatigue, pain, falls) using the intervention. Participants in two long-term care facilities will participate in this study. Measures will include feasibility outcomes regarding the logistics of the intervention as well as patients outcomes (falls, hospitalizations, and medications) collected before and after implementation. Findings will inform the design of a randomized controlled trial to test the effect of this intervention on health outcomes.

There are substantial associations between polypharmacy and reduced function from older adults and this is likely to be important in frail older adults both in long term care and in the community. The reversibility of drug-induced mobility impairment is unclear therefore the investigators plan to investigate signals of any impact of reducing polypharmacy on mobility. The investigators chose the long-term care setting given the presence of complete medication administration records and this patient population's high prevalence of polypharmacy and risk of adverse drug events. TAPERMD is an electronic tool for systematic medication reduction that incorporates patient priorities, electronic screening for potentially harmful medicines, supporting evidence tools and a monitoring pathway to support medication reduction. This study will examine the feasibility of this tool in a long-term care setting as well as examine. Participants in two long-term care facilities will participate in this study. Measures will include feasibility outcomes regarding the logistics of the intervention as well as patients outcomes (falls, hospitalizations, and medications) collected before and after implementation. Findings will inform a randomized controlled trial to measure the effect of this intervention on health outcomes.

Eligibility Criteria:
Inclusion Criteria:

* residing in 2 long-term care facilities in Brampton, ON
* on 5 or more medications
* 70 years of age or older
* adequate English language
A Phase 1b/2a, Open-label Single Ascending Doses and Multiple Ascending Doses Study in Participants with Pi*ZZ AATD

The purpose of this open-label study is to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of WVE-006 in participants with alpha-1 antitrypsin deficiency (AATD) following Period 1 single ascending dose (SAD) and Period 2 multiple ascending doses (MAD), respectively.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by the Investigator, based on a medical evaluation, or has mild to moderate AATD-induced lung disease (FEV1 ≥50%) and/or stable mild AATD-induced liver disease (≤F2 (≤10 kPa) on FibroScan.
* Genetic testing confirming Pi\*ZZ.
* Participant has been a non-smoker for at least 1 year prior to screening.

Exclusion Criteria:

* • Participant has a history of multiple drug allergies or of allergic reaction to an oligonucleotide or to N-acetylgalactosamine (GalNAc).

  * Participant has a history of intolerance or any medical condition that might interfere with subcutaneous injections.
  * Any ongoing or recent infections.
  * Any recent or planned vaccinations during the study.
  * Participant has a history of regular alcohol consumption exceeding 14 standard drinks/week.
  * Unwilling to abstain from alcohol for 48 hours prior to dosing at each of the dosing visits.
  * Any recent or planned major surgery during the study.
  * Participant has any medical condition or social circumstance that, in the opinion of the Investigator, would make the participant unsuitable for participation in the study or for dosing on Day 1, or could interfere with the assessments of safety, pharmacodynamics, or pharmacokinetics, or completion of the study.
  * Participant currently on AAT augmentation therapy, planned to be on augmentation therapy anytime during the study, or has been on augmentation therapy within 30 days prior to Screening Visit.
  * Donation of blood or blood products in excess of 500 mL within 12 weeks prior to Screening Visit and/or unwilling to refrain from blood donation for the duration of the study.
  * Participant has received an investigational agent within 3 months of the Screening Visit.
Telephone Counseling for Snuff Users

The primary objective is to evaluate the effectiveness of telephone-based counseling in promoting smokeless tobacco cessation among residents of Minnesota. It is hypothesized that a greater proportion of individuals assigned to the proactive telephone calls will quit their use of smokeless tobacco products and all tobacco products compared to the comparison group not receiving those calls.

Smokeless Tobacco (ST) users have not been the focus of tobacco control campaigns in Minnesota. However, there are a significant number of adults in Minnesota who regularly use ST. There is a need for a low-cost cessation program that can be widely delivered to ST users who may have little or no access to conventional and/or group treatments. Self-help interventions can make a significant contribution in reaching this population. The telephone provides a unique low-cost delivery system that can expand the reach of a self-help cessation program to underserved groups of tobacco users. The primary objective is to evaluate the effectiveness of telephone-based counseling in promoting smokeless tobacco cessation among Minnesota residents. It is hypothesized that a greater proportion of individuals assigned to the telephone calling group will quit their use of smokeless tobacco products and all tobacco products compared to the comparison group not receiving calls. We plan to recruit 400 smokeless tobacco users who are interested in quitting their use of smokeless tobacco and randomize them to telephone counseling for smokeless tobacco cessation or to a comparison group that receives the same mailed self-help materials. All subjects will be assessed pre-intervention, and at 3- and 6-months.

Eligibility Criteria:
Inclusion Criteria:

Age 18 or older. Use snuff or chewing tobacco weekly. Snuff or chewing tobacco are primary tobacco use.

Exclusion Criteria:

No access to a telephone. Primary tobacco use is cigarettes, cigar or pipe tobacco.
The Effects of Z-338 in Subjects With and Without Functional Dyspepsia

To assess in subjects with and without functional dyspepsia the effects of Z-338 on:

1. Type and severity of symptoms a standardized nutrient challenge
2. The gastric nutrient distribution and gastric emptying of a standardized nutrient challenge
3. The association of the above with the manifestations of symptoms and symptom pattern


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with functional dyspepsia Positive documented diagnosis of FD via RomeII criteria and three or more moderate symptoms of Gastrointestinal Score
2. Subjects with no history of functional dyspepsia Clinical assessment, physical examination and laboratory testing without evidence for relevant abnormality.

Other protocol-defined inclusion/exclusion criteria may apply.
First-line Treatment for Atrial Fibrillation in Cardiology and Geriatric Departments

In order to evaluate the implementation for the recommendations about the patient care for atrial fibrillation in aged patients, a non-interventional study is performed retrospectively by comparing two approach of the focus in Cardiology Department and in Geriatric unit.


Eligibility Criteria:
Inclusion Criteria:

* having an atrial fibrillation
* cared in Cardiology department or in geriatric unit

Exclusion Criteria:

* having a mitral valvulopathy, or a valvular disease with a surgery indication
* having a valvular prosthesis
* history of valve reconstruction