cyrilzakka/clinical-trials huggingface dataset:
Effects of Using Decision Cycle for Person-Centered Glycemic Management in Type 2 Diabetes

Decision cycle for person-centered glycemic management is a new diabetes decision making .It is defined as a purposefully designed holistic care intervention .The goal is to improve the self-care behavior of patients with type 2 diabetes, thereby improving glycated hemoglobin levels and delaying the occurrence of complications.

The "Decision Cycle for Person-Centered Glycemic management" jointly proposed by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) in 2018 , which develops treatment goals and plans based on the patient's personal preferences, values, and goals.

Participants will be divided into two groups(treatment group 、control group).Treatment group will accept the "Decision Cycle for Person-Centered Glycemic Management " .It is a person-centered diabetes decision making. Control group will accept the traditional diabetes self-management education. It content focuses more on teaching relevant knowledge and some skills.It is a educator-centered approach.

Baseline / pre-intervention test (after signing informed consent form) post-intervention test (after finishing intervention) Researchers will compare treatment group and control group to see if treatment group has better performance on self-care Behaviors and glycated hemoglobin levels .

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with type 2 diabetes by a physician.
2. Age: 18 years or above.
3. Glycated hemoglobin (HbA1c ) test value: 7.5-9.0 %
4. No diabetic oral medications, insulin and glucagon-like peptide-1 were replaced in the outpatient when the case was admitted.
5. No pregnancy during the study period.
6. After the researcher explains the purpose of the research, the research subjects agree to join this researcher.
7. Those who are conscious and able to take care of themselves.
8. There is no diagnostic certificate from the American Psychiatric Association's Diagnostic Manual of Mental Disorders, Fourth Edition (DSM-IV)of all mental illnesses.
9. Those who can communicate in Mandarin and Taiwanese.

Exclusion Criteria:

1. Patients diagnosed with type 1 diabetes by a physician.
2. Age: Under 18 years old.
3. Glycated hemoglobin test value: less than 7.5 % and greater than 9.0 %
4. Those who replaced oral diabetes medications, insulin and glucagon-like peptide- 1 at the outpatient at the time of admission.
5. Pregnancy during the study period.
6. Those who are unable to take care of themselves and express themselves.
Multilayer Biological Characterization of Advanced Follicular Lymphoma: a Translational Study From FIL_FOLL12 Trial

This is a Multicenter, Retrospective, Biological study ancillary to FOLL12 trial to evaluate the role of EZH2 aberrations in patient with FL treated with immunochemotherapy. Moreover, several novel biomarkers of FL will be investigated.

Current standard first-line treatment for advanced follicular lymphoma (FL) is still represented by chemoimmunotherapy combinations, with CHOP/CVP or bendamustine (B) as the main regimens with no standard criteria to prefer one over another.

EZH2 mutations have been associated with longer progression-free survival (PFS) in patients treated with CHOP/CVP regimens, but not with Bendamustine (independently from the type of anti-CD20 therapy received).

The FIL_FOLL12 trial (NCT02063685), a large phase III trial (with a pre-planned biological material sampling) enrolling 807 advanced FL patients treated with front-line R-CHOP or bendamustine-rituximab (BR), appears an ideal platform to validate the predictive value of EZH2 and its applicability to the clinical practice.

The aim of this study is to provide to clinicians a useful and practical biomarker to guide the choice of the most effective chemotherapy backbone (in addition to anti-CD20 immunotherapy) for first line treatment of patients with advanced FL (e.g. R-CHOP for EZH2 aberrated vs BR for EZH2 wild type patients).

Moreover, to implement an Italian network of laboratories able to provide these translational outputs within a rapid turnaround time.

Finally, taking advantage of the already collected BM and PB samples, several novel biomarkers of FL heterogeneity will be investigated, in particular: EZH2 protein expression in tumor samples, alternative molecular markers for minimal residual disease (MRD), clonal hematopoiesis of indeterminate potential (CHIP), pharmacogenomics and constitutional genomics as well as microbiome profiles.

Eligibility Criteria:
Inclusion Criteria:

* Patient enrolled in the FIL_FOLL12 trial (documented by the signature of the study informed consent);
* Availability of biological samples: bone marrow aspirate, peripheral blood and/or FFPE diagnostic sample (nodal or extranodal);

Exclusion Criteria:

* None
Neurofeedback for Treatment-resistant Obsessive-compulsive Disorder (OCD)

The aim of this study is to teach participants with a OCD diagnosis and treatment-resistance how to decrease the response from a brain region involved in the disease by using a technique called neurofeedback. While using this technique, the participants visualize their own brain response in a screen during a MRI exam. Participants will learn strategies to decrease brain responses. The neurofeedback technique is non-invasive, without known risks to participants. With this study, it is expect that the neurofeedback training over 2 weeks (2 sessions) will reduce the OCD symptoms when compared to a control intervention based on neurofeedback's placebo effects.

OCD individuals will be recruited at Hospital of Braga, Braga, Portugal, in collaboration with the Psychiatry Unit (n = 30, nonrandom convenience sample based on effect size of 0.30, alpha = beta = 0.05, and ANOVA repeated measures within-between interaction). Some participants may quit the study but sample size was predetermined considering a putative 30 percent dropout rate. Clinical history will be assessed (sociodemographic information, disease onset and severity, and previous/current treatments). The participants' neuropsychological state, the blood hormonal levels, and brain function and structure as baseline measures before and after the neurofeedback intervention will be assessed. Two MRI neurofeedback sessions will be performed during 2 weeks (2 distinct days; 36 min per session) in a 3 T MRI scanner. Data analysis will be performed with a repeated measures design (baseline and after neurofeedback) between the groups to measure brain, blood, and neuropsychological changes. Patients will be supervised by a physician to track putative complications/adverse effects during the intervention. The participation will be immediately interrupted in case of adverse reactions or symptomatic worsening and a physician will follow the participants to provide the appropriated care.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of current OCD according to the fifth Diagnostic and Statistical Manual of Mental Disorders;
* Treatment resistance (≥ 3 selective serotonin reuptake inhibitors in proper dose for ≥ 12 weeks).

Exclusion Criteria:

* Concomitant psychiatric or neurological illness;
* Substance abuse/dependence in the past 6 months (except nicotine/caffeine);
* Acute suicidal ideation;
* Psychotropic medication (except selective serotonin reuptake inhibitors, anafranil, or low-dose hypnotic or anxiolytic taken occasionally);
* MRI contraindications (pregnancy, major head trauma, severe claustrophobia, severe back pain, ferromagnetic materials/prostheses/implants inside the body, or other).
Post-Marketing Surveillance of Micombi Tablets Survey on the Long-term Use

The survey is conducted to collect safety and effectiveness information in Hypertensive patients treated with Micombi Tablets on the long term use in daily clinical settings in Japan.


Eligibility Criteria:
Inclusion criteria:

Hypertensive patients who have never taken Micombi Tablets.

Exclusion criteria:

None
High-intensity Interval Training and Telerehabilitation

Telerehabilitation has the potential to become an alternative attitude to outpatient cardiac rehabilitation. The aim of our study is to research the method of high-intensity interval training in the home environment using telerehabilitation. Investigators assume that the high-intensity interval training form of telerehabilitation, using a heart rate monitor as a tool for backing up training data, can improve physical fitness and lead to higher peak oxygen uptake as the traditional moderate-intensity continuous training. The study is designed as a monocentral randomized controlled trial at University Hospital Brno in the Czech Republic.

After the coronary event, eligible patients will be randomly (in 1:1 ratio) separated into two groups: the experimental high-intensity interval training group and the moderate-intensity continuous control group. Both groups undergo a 12-week telerehabilitation training program with a 52-week follow-up period. The primary outcome observed will be the effect of intervention expressed by changes in peak oxygen uptake values.

The study relates to the previous study project CR-GPS, in which investigators proved the feasibility of cardiac telerehabilitation. The results showed that aerobic capacity and quality of life improved similarly in telerehabilitation and outpatient group of participating patients. During the research, investigators used the moderate-intensity continuous method. The present research focuses on high-intensity interval training, which presents comparable or even better results in cardiorespiratory condition effects and requires less time than a continuous method in patients with low or medium cardiovascular risk.

Eligibility Criteria:
Inclusion Criteria:

* Participants with coronary artery disease (in last two months)
* with low or medium cardiovascular risk
* with heart revascularization
* with recommended pharmacotherapy
* with clinically stable state
* with the ability to perform a cardiopulmonary exercise test
* with the ability to understand and write in the Czech language
* with an internet connection at home
* literacy with information and communication technology

Exclusion Criteria:

* Participants who were hospitalized with heart disease in the previous six weeks
* with psychological severe or cognitive disorders
* with contraindications for cardiopulmonary exercise testing
* with severe training limitations besides coronary artery disease
* with a planned intervention or operation
* participants who are enrolled in or participate in an outpatient form of cardiac rehabilitation
* participants who plan to be or are included in other studies
A Study (Study 2) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea

The primary objectives of this study are to determine the efficacy and safety of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea.

This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy of FMX103 topical foam containing 1.5% minocycline compared to vehicle, in the treatment of participants with moderate-to-severe facial papulopustular rosacea. Qualified participants will be randomized in a 2:1 ratio (active:vehicle) to receive 1 of the following 2 treatments:

* FMX103 minocycline foam 1.5%
* Vehicle foam

Participants will be assigned to 1 of 2 treatments according to the randomization schedule. Participants will apply (or have applied) the study drug topically once daily for 12 weeks as directed. Participants will be advised to use the study drug at approximately the same time each day. Both the Investigator and participant will be blinded to the study drug identity. Participants will return for visits at Weeks 1, 4, 6, 8, 10, and 12. Efficacy evaluations (inflammatory lesion counts and Investigator's Global Assessment \[IGA\] score) will be performed at Weeks 4, 8, and 12 during the study.

Note: Originally the two studies FX2016-11 and FX2016-12 were combinedly presented in the protocol registration form under one NCT number (NCT03142451), and later separated since results were analyzed separately.

Eligibility Criteria:
Inclusion Criteria:

1. Moderate-to-severe rosacea (as per the IGA score) on the proposed facial treatment area consisting of:

   1. At least 15 and not more than 75 facial papules and pustules, excluding lesions involving the eyes and scalp;
   2. No more than 2 nodules on the face.
2. Presence of or history of erythema and/or flushing on the face.

Exclusion Criteria:

1. Presence of any skin condition and/or Excessive facial hair, on the face that would interfere with the diagnosis or assessment of rosacea.
2. Moderate or severe rhinophyma, dense telangiectasia (score 3, severe), or plaque-like facial edema.
3. History of hypersensitivity or allergy to minocycline, any other tetracycline, or of any other component of the formulation.
4. Active ocular rosacea (eg, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.
Vital Signs Patch: Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting

This feasibility study evaluates the use of the Vital Signs Patch (VSP) System to take and monitor specified vital signs. It will be used in parallel with the normal equipment the study site uses to take and monitor vital signs.

To assess the feasibility and usability of the total Vital Signs Patch (VSP) System in an actual hospital environment on in-patients by monitoring specified vital signs. The VSP System will be assessed for incorporation into the study site's Information Technology infrastructure. The VSP measurements will be compared with the predetermined expected results of the established vital signs equipment normally used by the facility based upon clinician protocols.

The VSP System can take and monitor patient vital signs in a more reliable and consistent manner by removing the human variability that occurs when clinicians manually take a patient's vital signs. The VSP has been designed to automatically take and monitor the following vital signs:

* Arterial blood oxygen Saturation (SpO2)
* ECG (up to 3 - Lead)
* Heart Rate (Part of ECG)
* Surface Temperature
* Respiration

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female hospital in-patients
* Vital signs considered 'stable' by clinical caregivers

Exclusion Criteria:

* Pediatric patients
* Female patients who are pregnant
* Patients with internal or external defibrillators
* Patients who have undergone surgery and still have a fresh incision on the chest
* Patients with skin damage on the chest such as burns, irritation, infections, wounds, etc.
* Patients who are in the Critical Care Unit (CCU)
* Patients who otherwise satisfy any of the contraindications associated with the VSP system.
Reclaim Deep Brain Stimulation Clinical Study for Treatment-Resistant Depression

Medtronic, Inc. sponsored an investigational study of the Reclaim™ Deep Brain Stimulation (DBS) System in people that have treatment-resistant depression. Depression is a mood disorder and a serious medical condition that affects millions of Americans. Depressive symptoms may include loss of interest in things typically enjoyed; decreased energy levels; difficulty concentrating or making decisions; restlessness; and feelings of pessimism, hopelessness, and worthlessness. Treatment-resistant depression is a chronic and severe form of depression characterized by failure to respond to traditional forms of treatment, such as antidepressant medications and electroconvulsive therapy. Treatment-resistant depression significantly impacts quality of life, productivity, and is a major contributor of disability world-wide.

This randomized, double-blind, sham stimulation-controlled, multi-center, prospective, parallel design study used deep brain stimulation technology to test whether active bilateral stimulation can safely and effectively improve depressive symptoms in patients with treatment-resistant depression compared to sham stimulation.

Participants meeting criteria for the study were implanted with the Reclaim DBS System. Participants in the active group, who received active stimulation, were compared to the control group, who received sham stimulation, during the 16-week blinded-treatment phase. All participants were monitored for changes in depressive symptoms. After the blinded-treatment phase, all participants received active stimulation.

Candidates for the trial were adults who had major depressive disorder and had not responded to several treatments for depression. Participants in the study continued to receive their current antidepressant medications while participating in the trial.


Eligibility Criteria:
Inclusion Criteria:

* Consent to participate in screening and study procedures by signing and dating the Informed Consent Form
* Are diagnosed with major depressive disorder (MDD)
* Have tried at least 4 different treatments, for example antidepressant medications, combinations of antidepressant medications, and/or electroconvulsive therapy (ECT)
* Screening MADRS score ≥ 28
* Have had the current major depressive episode persist for at least 2 years
* Females, if of child-bearing potential, must be using an acceptable method of birth control

Exclusion Criteria:

* Females: Currently pregnant
* Currently enrolled in or plan to enroll in any concurrent drug and/or device study that may confound the results of this study
* Have a neurological condition that may jeopardize the safety or the conduct of the study
* Have any medical conditions unsuitable for undergoing DBS surgery
Green Digital Diabetes Waste Project

The purpose of this study is to determine how people with diabetes are disposing of various products and devices and at what rates so that better devices with less waste can be designed in the future.

The study aims to compare the amount of environmental waste that is generated during the management of diabetes of participants who are using a CGM and on multiple daily injection (MDI) or using an AID (automated insulin delivery) system. This study is expected to demonstrate which devices create the most waste and where opportunities exist to decrease diabetes device waste. We will collect data to describe both quantitatively (via daily survey) and qualitatively (via photography) the types of waste that are generated during the management of diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Person with diabetes (self-identified), either type 1 or type 2, who has been diagnosed at least 6 months earlier
* Age 18 years and above
* Use of a CGM
* Use of an insulin pump or on MDI
* Access to the Internet and e-mail
* Access to a smartphone with photographic capability
* Able and willing to provide informed consent

Exclusion Criteria:

* Failure to meet any of the inclusion criteria
* Any condition which, in the opinion of an investigator, would make the subject not qualified to participate in the study.
* Adults unable to consent
* Adults unable to speak English
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Cognitively impaired adults
HEPMET-1: Evaluate the Feasibility, Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a MMT Group.

* To evaluate if weekly psychological follow-up make opioid dependent patients in MMT able to accomplish 14 weeks treatment with Peginterferon alfa-2a (PEG-INF) and ribavirin to the same extent than non-opioid dependents.
* To determine the efficacy of this anti-HCV treatment

Chronic infection with the hepatitis C virus (HCV) is a health problem worldwide. In Norway, there are about 3000 patients participating in Methadone Maintenance Treatment(MMT) programs. A prevalence study at the MMT treatment unit in Kristiansand, showed that more than 90 % of 177 patients have been infected with hepatitis C.

A major problem with anti-HCV treatment for this group is the lack of compliance and retention in treatment. Further, due to the high incidence of psychological disorders in opioid dependent patients, this may also complicate anti-HCV treatment. Drug addicted in MMT treatments programs may find themselves excluded from Hepatitis C treatment.

Due to better treatment efficacy with the new PEG-INF's and encouraging reports from 14 weeks studies, it may be easier to motivate opioid dependents to fulfill treatment. Weekly psychological follow-up of these patients will further increase the possibility of opioid dependents in MMT to be able to complete anti-HCV treatment.

The aim of this study is to focus on this patients situation, and strengthen their possibility to have a real opportunity to get treatment. We therefore wish to make a pilot study to investigate the feasibility, efficacy and psycological side-effects of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Serologic evidence of hepatitis C infection, genotype 2 and 3
* Normal or elevated serum ALT activity
* In MMT-programme and with at least 6 months with satisfactory drug abuse control. That means no iv injections and no or minimal use of drugs.
* Male and female patients

Exclusion Criteria:

* Women with ongoing pregnancy or breast feeding
* Untreated serious psychiatric disorders, particularly depression.
* Serious drug abuse or alcohol abuse last 6 months
* Intravenous drug abuse last 6 months
* Hepatitis A, B or HIV infection
* HCV genotype 1, 4, 5 and 6
* Leucocytes \< 3000 cells/mm3 at screening (neutrophil count \<1500 cells/mm3)
* Platelet count \< 80 000 cells/mm3 at screening
* Hb \<11 g/dL in women or \<12 g/dL in men at screening
* Documented or presumed coronary artery disease or cerebrovascular disease
* Thyroid dysfunction not adequately controlled
* Epilepsy
* Malignant disease
Electrochemotherapy (ECT) in Patients With Primary Visceral Tumors and/or Secondary Visceral Localizations, of Any Histotype

This is an monocenter, single arm, clinical investigation that evaluate the impact of the method on the objective response rate (ORR) of visceral lesions undergoing electrochemotherapy. Electrochemotherapy is a well-defined method for the treatment of cutaneous and subcutaneous metastases of different tumor histotypes.

Although still limited, the various experiences in the treatment of visceral localizations, particularly in liver metastases from colorectal cancer are promising and show that electrochemotherapy is a safe treatment, even in the case of lesions near large vessels or nerves. The investigators therefore propose a clinical investigation with a Medical Device according to EU Regulation 745/2017, using electrochemotherapy (Cliniporator) with bleomycin for the treatment of visceral, primary or secondary, unresectable localizations, with percutaneous or intraoperative technique (laparoscopic or laparotomy), as needed.

This is a single-center clinical investigation with the enrollment of at least 24 patients with visceral, primary or secondary localizations, of any histotype, with particular reference to liver cancer, liver metastases from colorectal cancer and melanoma, primary pancreatic tumors, retroperitoneal sarcomas, abdominal and/or peritoneal localizations from melanoma and non-melanoma skin cancer (Merkel cell carcinoma, Squamous cell ca).

Eligibility Criteria:
Inclusion Criteria:

* Male/Female ≥ 18 years
* Ability to understand the proposed treatment and express an informed acceptance by signing the informed consent
* Diagnosis of primary and/or secondary visceral localizations of any histotype
* Patients who are not eligible for standard curative procedures

Exclusion Criteria:

* Absolute contraindications to invasive procedures
* Concomitant presence of brain, lung, bone metastases
* Uncorrectable coagulation changes
* Bleomycin allergy
* Absolute contraindications to taking Bleomycin
* Poor respiratory function or pulmonary fibrosis
* Acute lung infections
* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study