cyrilzakka/clinical-trials huggingface dataset:
Non-invasive Neurostimulation as a Tool for Diagnostics and Management for Neurodegenerative Diseases

Double blinded, sham-controlled, randomized trial on repeated transcranial alternating current brain stimulation (tACS) in neurodegenerative diseases. The investigators will evaluate whether a 4-times daily repeated stimulation with gamma tACS on the posterior parietal cortex can improve symptoms in patients with neurodegenerative diseases, including dementia with Lewy Bodies, Alzheimer's disease, idiopathic normal pressure hydrocephalus and Frontotemporal dementia.

Double blinded, sham-controlled, randomized trial on repeated transcranial alternating current brain stimulation (tACS) in neurodegenerative diseases. The investigators will evaluate whether a 4-times daily repeated stimulation with gamma tACS on the posterior parietal cortex can improve symptoms in patients with neurodegenerative diseases, including dementia with Lewy Bodies, Alzheimer's disease, idiopathic normal pressure hydrocephalus and Frontotemporal dementia.

Eligibility Criteria:
Inclusion Criteria:

* Mild Cognitive Impairment due to Alzheimer's disease
* Dementia with Lewy Bodies
* Frontotemporal dementia
* Idiopathic normal pressure hydrocephalus (iNPH)

Exclusion Criteria:

* History of seizures
* Pregnancy
* Metal implants in the head (except dental fillings)
* Electronic implants (i.e. pace-maker, implanted medical pump)
* Age \<18 years
Vitamin E Supplementation in Burned Patients

A dietary antioxidant, alpha-tocopherol, will be used to potentially attenuate Vitamin E short- and long-term losses in plasma and adipose, reverse the oxidative stress of burn injury and, in the process, decrease the secondary consequences of burn injury, including lung injury and impaired wound healing. This may improve the quality of life of the burn patient by preventing pathophysiology that may result from oxidative stress and may reduce hospital stay. Our research will lay the foundation for the future development of effective, safe, and economic therapeutic interventions to treat burn injury-associated metabolic abnormalities. Also, it will provide the basis for the development of supplemental regulations and pharmacotherapy to treat burn patients with vitamin E. The risks are very reasonable in relation to the anticipated benefits to our subjects because a) vitamin E is a simple vitamin that is abundant and approved for clinical use, and b) the subjects will be monitored consistently for the minimal increased tendency to bleed.

Please see above.

Eligibility Criteria:
Inclusion Criteria:

* Age: 16 - 85 years
* ≥40% total body surface area burn

Exclusion Criteria:

* Septic shock
* Bleeding disorders
* Diabetes, or on diabetes medications or anti-lipidemic agents
* Arthritis
* Known kidney/renal disease, endocrine disease, cancer, heart disease, osteoporosis, liver disease
* Congestive heart failure
* Positive hepatitis or HIV screens
* Pregnancy (women)
Postural and Anthropometric Properties of Foot and Ankle of Patients With DMD

Introduction: Progressive muscle weakness, joint contractures and body alignment disorders seen in patients with Duchenne Muscular Dystrophy (DMD) adversely affect the foot structure of the patients.

Objective: The aim of this study is to examine the relationship between foot posture, performance and ambulation in patients with DMD.

Method: The patient with ambulatory DMD will be included in the study. The foot postures of the patients will be evaluated with the Foot Posture Index. Relationships between the Foot Posture Index and performance tests (6 minute walk test, timed performance tests (10m walking, Gower's, climb/descend 4 stair)) and the North Star Ambulation Evaluation, an ambulation evaluation, will be examined.


Eligibility Criteria:
Inclusion Criteria:

1.5 to 18 years old 2. Not to have lost his ambulation 3. Agreeing to participate in the research voluntarily

Exclusion Criteria:

1. Having serious mental and psychological problems,
2. Having lost his ambulation
3. Inability to cooperate adequately with the physiotherapist who made the evaluations,
4. Any injury and/or surgery to the lower extremities in the last 6 months.
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.


Eligibility Criteria:
Inclusion Criteria:

* Weight greater than or equal to (\>=) 10 kilogram (kg) at the time of consent for screening
* A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) must be available in the source documents. There is no maximum duration for which a participant needs to be diagnosed with UC. If the pathology report to support a documented diagnosis of UC is not available in the source documents, the screening endoscopy with biopsies (obtained within 3 weeks before first study intervention administration) needs to support the diagnosis of UC.
* Moderately to severely active UC, defined by a baseline modified Mayo (without physician's global assessment) score of 5 through 9 inclusive, with a screening Mayo endoscopy subscore \>= 2 as determined by a central review of the video of the endoscopy
* Medically stable based on physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator
* Participants must have had an inadequate response and/or intolerance to biologic therapy and/or conventional therapies or be dependent upon corticosteroids

Exclusion Criteria:

* Have UC limited to the rectum only or to less than (\<) 20 centimeter of the colon
* Presence of a stoma
* Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months of baseline
* Have severe colitis or have evidence of Crohn's Disease (CD)
Bone Marrow Stem Cell Mobilisation Therapy for Acute Myocardial Infarction (AMI)(REVIVAL-2)

The purpose of this study is to determine whether stem cell mobilization by granulocyte colony-stimulating factor (G-CSF) therapy in patients with acute myocardial infarction after successful mechanical reperfusion reduces infarct size.

Experimental studies and early-phase clinical trials suggest that transplantation of blood-derived or bone marrow-derived progenitor cells may improve cardiac regeneration after acute myocardial infarction. Granulocyte colony-stimulating factor (G-CSF) induces mobilization of bone marrow stem cells and, thereby, increases the number of circulating stem cells that are available cells for myocardial regeneration.

Eligibility Criteria:
Inclusion Criteria:

* ST-elevation acute myocardial infarction (5 days before randomization)
* Successful percutaneous coronary intervention \[PCI\] (performed within 12 hours from symptom onset)
* Scintigraphic infarct size \>5% of left ventricle
* Written informed consent

Exclusion Criteria:

* Age \<18 years or \>80 years
* Congestive heart failure defined as Killip class \>2
* A history of myocardial infarction
* Electrical or hemodynamic instability
* Autoimmune diseases
* Fructose intolerance
* Malignancies
* Incompatibility of filgrastim
* Known or suspected pregnancy
The Establishment of Multiple Point Prediction Model About Tacrolimus Metabolic Differences Based on Genetic Network After Liver Transplantation and the Application of Multicenter

Combined with the clinical data of FK506 and the database of GO and Kyoto Encyclopedia of Genes and Genomes（KEGG）, the investigators aim to carry out the bioinformatic analysis and build a muti-locus genetic model, then muti-center assess the predictive accuracy of FK506 metabolic differences.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of end-tage liver diseases
* 18 years old or above
* Han nationality
* Therapeutic regimen：TAC

Exclusion Criteria:

* Less than 18 years old
* Other races
* Therapeutic regimen：cyclosporine
Piloting a School-Based Distress Tolerance Skills Program for Adolescents

Research suggests that an individual's perceived ability to withstand distressing or upsetting emotions (i.e., distress tolerance; DT) is a common risk factor across several mental health conditions that commonly emerge during adolescence. This study aims to evaluate the acceptability, feasibility, and initial efficacy of a classroom-based DT skills training program for middle school students. This study will also explore associations between changes in DT and internalizing symptoms (e.g., anxiety, depression).

A variety of deleterious mental health conditions have their peak age of onset in adolescence, including depression and anxiety. Distress tolerance (DT) - defined as the perceived or actual ability to withstand aversive emotional states - has been postulated as a transdiagnostic risk factor across several "emotional" disorders that typically emerge during adolescence. Importantly, while there is compelling evidence that DT is associated with emotion dysregulation and symptom severity, it is unclear whether modifying DT can reduce future risk for psychopathology in adolescent populations. This proposal aims to evaluate the feasibility, acceptability, and initial efficacy of a classroom-based DT intervention for middle school students. Additionally, this proposal will examine associations between changes in DT and internalizing symptoms.

Primary Objective:

To evaluate the acceptability, feasibility, and efficacy of a classroom-based DT skills training program for middle school students.

Secondary Objectives:

To examine whether participation in the DT skills training program is associated with lower severity of internalizing symptoms over the course of the academic year.

Eligibility Criteria:
Inclusion Criteria:

* Middle school aged-youth attending Valley Catholic Middle School in grade 6, 7, or 8

Exclusion Criteria:

* None
Internet-CBT for Gambling Disorder - a Randomized Controlled Trial

The study is a randomized controlled trial (Total N=150; each condition n=75) of internet-based cognitive behavioral therapy (iCBT), with measures at pre, weekly during treatment, post, three and at six month follow-up. Participants will be assigned to either standard iCBT and "Spelpaus" (treatment condition), or "Spelpaus" only (control condition).

Recruitment will be done through online advertisement via social media and gambling-related websites. Participants will self-referred to the study via a study dedicated website (www.spelstudien.se). Login to a treatment platform will be verified using double authentication (detailed description of the online platform is provided in the application to the Swedish Ethical Review Authority). Written information about the study will be provided on the web page. Consent will be done online, with the possibility for participants to download study information and consent. Consenting participants will start a screening procedure. After screening, participants will be contacted for a telephone assessment with a clinical psychologist. During this interview, participants will be assessed for GD with a diagnostic interview, as well as the inclusion criteria for utilization of "Spelpaus". If meeting criteria for the study, participants will be referred to the baseline/pre-measures - which will start with an additional informed consent for the treatment phase and the iCBT. Inclusion will be done after the completion of the informed consent and baseline/pre-measures. After that, participant will be randomized to iCBT and "Spelpaus" (treatment condition), or "Spelpaus" only (control condition). Randomization will be conducted by a third party using a true random service, https://random.org. Participants assigned to the control condition in the randomized controlled trial will receive a voucher of total 1000 Swedish Krona's when completing the post and follow up measures. Participants assigned to the control condition in the randomized controlled trial will receive a voucher of total 1000 Swedish Krona's when completing the post and follow up measures.

Eligibility Criteria:
Inclusion Criteria:

* Screen positive for GD, as measured with the Gambling Disorder Identification Test (total score ≥20 GDIT).
* Fulfilling GD, assessed according to the Structured Clinical Interview for Gambling Disorder (SCI-GD).
* Utilization of "Spelpaus", 3 months from treatment start.
* ≥18 years of age.
* Able to provide digital informed consent.

Exclusion Criteria:

* Other ongoing psychological treatment for GD.
* Severe depression, screened according to the Montgomery Åsberg Depression Rating Scale (total score \>34 MADRS-S).
* Suicidality, screening of ≥4 points on item 9 of the MADRS-S
Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2)

The main purpose of this study is to investigate efficacy and safety of three doses of petrelintide versus placebo in participants with overweight or obesity and type 2 diabetes.


Eligibility Criteria:
Main Inclusion Criteria:

* Male or female participants with body mass index (BMI) ≥27.0 kg/m2.
* Diagnosed with type 2 diabetes ≥180 days prior to the day of screening.
* Treated with metformin with or without sodium-glucose cotransporter 2 inhibitors. Treatment should be stable (same drug\[s\], dose, and dosing frequency) for at least 90 days prior to screening.

Main Exclusion Criteria:

* Severe hypoglycemia within 6 months prior to screening or history of hypoglycemia unawareness.
* Receipt of any other glucose-lowering drug than those listed in the inclusion criterion within 90 days prior to screening.
* A self-reported change in body weight \>5% within 90 days prior to screening, irrespective of medical records.
* Treatment with any medication (prescribed or over-the-counter) or alternative remedies (herbal or nutritional supplements) intended to promote weight loss within 6 months prior to screening.
* Previous or planned (during the trial period) obesity treatment with surgery or a body weight loss device. However, liposuction or surgical removal of fat depots more than 1 year prior to screening or device-based interventions (e.g., sleeve, banding, or similar) that have been removed more than 6 months prior to screening, are allowed.
* Obesity due to endocrine disorders or genetic syndromes.
Self-efficacy Enhancement and Exposure Therapy

Self-efficacy refers to the perceived belief to cope effectively, by personal efforts, with challenging situations and problems (Bandura, 1977). Basic research has shown that increases in perceived self-efficacy can enhance the extinction of fear (Zlomuzica et al., 2015). This study is aimed at translating these findings into a useful clinical application to augment exposure-based treatment outcome.

In this study, the effects of self-efficacy enhancement on treatment outcome in patients with height phobia will be investigated.

Participants will be randomly assigned to one of the following conditions: i) virtual reality exposure + self-efficacy enhancement; ii) virtual reality exposure + control intervention; iii) virtual reality exposure only. The amount of exposure is identical across groups (i.e. maximum of 1 hour of exposure). The self-efficacy and the control intervention involve the retrieval of the exposure session with or without a focus on personal mastery experiences/achievements, respectively.

Treatment-induced changes as well as the effects of self-efficacy enhancement will be measured on the subjective level (i.e. in-vivo Behavioral Approach Tests, BATs; church tower), physiological level (heart rate during the BATs), and subjective level (subjective fear during the BATs as well as height-phobia related questionnaires) at each of the three assessments (i.e. pretreatment, after which the exposure will conducted on the same day, i.e. day 1; posttreatment, which is scheduled approximately 2-3 days after exposure, and follow-up assessment, which will take place 1-month after exposure).

Eligibility Criteria:
Inclusion Criteria:

* specific phobia (acrophobia)
* normal or corrected vision

Exclusion Criteria:

* somatic or neurological disease
* personality disorder
* bipolar disorder
* acute drug- or alcoholabuse
* pharmacological treatment within the past 4 weeks
* mental retardation
* any schizophrenic disease
Hemorrhagic MI Prediction Score Model

Developing a prediction score model for predicting the likelihood of Hemorrhagic MI


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 yrs
* Index MI
* Primary PCI

Exclusion Criteria:

* History of prior myocardial infarction,
* Thrombolysis before PCI
* Contraindication to Cardiac MRI
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccines in France.


Eligibility Criteria:
Inclusion Criteria:

* Healthy 2-month-old infants.
* Available for the entire study period.

Exclusion criteria:

· Known contraindication to vaccines.
Evaluation of BTV100 in Subjects With Dry Eye Disease

This study will be a randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study to evaluate the efficacy, safety and tolerability of repeat dosing of Cevimeline Ophthalmic Solution compared to the vehicle in subjects with Dry Eye Disease (DED).

At the screening visit/Visit 1 (Day 1 minus 14 days), subjects who are eligible according to the inclusion and exclusion criteria will begin a 14-day run-in period during which they will self-administer 1 drop of single-masked vehicle to each eye twice daily (BID), morning and evening (at least 6-hour interval). At the time of the screening visit/Visit 1, subjects will be instructed to discontinue all over the counter (OTC) and prescription topical ophthalmic medications except for the vehicle or study drug throughout the study.

At Baseline/Visit 2 (Day 1), subjects who continue fulfilling inclusion/exclusion criteria will be randomized to study drug or vehicle.

Approximately120 subjects will be randomized. Subjects will be randomized to one of the following 4 treatment groups. Following randomization, subjects being masked to treatment assignments will be instructed to self-administer 1 drop of investigational product (IP) into each eye twice daily, morning and evening (at least 6-hour interval). Subjects will be instructed to return to the clinic to be evaluated at Day 15 (Visit 3), Day 29 (Visit 4), Day 57 (Visit 5), and Day 85 (Visit 6).

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older (regardless of gender).
2. Provide written informed consent.
3. Willing and able to follow instructions and be available for required study visits during the study.
4. Best Corrected Visual Acuity (BCVA) of 20/100 or better in both eyes.
5. Ongoing moderate to severe Dry Eye Disease (DED) supported by a previous clinical diagnosis or a self-reported history of subjective complaints for at least 6 months prior to the screening visit, and meet all the following criteria in at least one eye (the same eye) at Visit 1 and Visit 2:

Exclusion Criteria:

1. Known hypersensitivity or contraindication to the study drug or its components.
2. Within 28 days prior to the screening visit (Visit 1), have taken or used: Topical ophthalmic, dermatologic or systemic calcineurin inhibitor (e.g. cyclosporine and tacrolimus), including Restasis® (cyclosporine) and Cequa® (cyclosporine)
3. Current use of contact lenses or anticipated use during the study.
Transcranial Magnetic Stimulation and Anti-epileptic Effect: Optimization and Evaluation With Electrophysiology.

Epileptic disease is characterised by enhanced brain excitability. Low frequency repetitive transcranial magnetic stimulation (rTMS) can be an effective treatment for refractory frontal epilepsy. Thought, physiological mechanisms of its effectivity are still unknown. It is yet possible to evaluate cortical excitability and inhibition with TMS-coupled electromyography before and after rTMS sessions ; this could provide clues for basic mechanisms of rTMS effects on the epileptic brain. We assume that rTMS decrease brain excitability by improving brain inhibition. Such an information could help for treating patients with both pharmacological and non-pharmacological methods.


Eligibility Criteria:
Inclusion Criteria:

* Cryptogenic frontal lobe epilepsy
* Normal cerebral MRI
Study of Nab-paclitaxel (Abraxane®) Treatment in Patients With Metastatic Breast Cancer in Routine Clinical Practice

This is a national, multicenter, retrospective, observational post-authorization study (EPA-OD) study. The study will be conducted by reviewing the medical records of patients up to the start of the study. In each case, only data from before the start of the study will be obtained in order to ensure they are retrospective in nature, thus reflecting the regular use of nab-paclitaxel in clinical practice and avoiding interference with the physician's clinical practice.

To ensure the observational nature of this study, these data will be collected whenever they are available in the patient's medical record, and so no diagnostic or therapeutic intervention outside regular clinical practice will be used.

This is a national, multicenter, retrospective, observational post-authorization study (EPA-OD) study. Investigators will include all consecutive adult patients diagnosed with HER2-negative MBC who have started treatment with nab-paclitaxel monotherapy no further than the third line of chemotherapy for metastatic disease during the past 3 years (2012-2014). These patients must meet all the inclusion criteria and none of the exclusion criteria established in this protocol.

The primary objective is to describe the effectiveness of nab-paclitaxel in terms of response in early lines of chemotherapy for metastatic breast cancer in routine clinical practice.

This study plans to collect data retrospectively, provided they are available in the patient's medical record and according to routine clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Women ≥18 years of age.
* Confirmed diagnosis of MBC (stage IV).
* Breast adenocarcinoma confirmed histologically.
* HER2-negative according to the American Society of Clinical Oncology (ASCO) and Anatomical Pathology (CAP) criteria for the detection of HER2 in breast cancer.
* Patients who have started treatment with nab-paclitaxel monotherapy no further than the third line of chemotherapy for metastatic disease in HER2-negative breast cancer during the period 2012-2014 (3 years) and who have received at least one cycle of treatment.
* Ability to give informed consent, preferably in writing or orally in front of a witness, before the start of data collection (if it is able to be given).

Exclusion Criteria:

* Patients with any medical or psychological disorder which in the investigator's opinion might compromise the ability of the patient to give their informed consent.
* Patients who have received treatment with nab-paclitaxel combined with other chemotherapy agents or anti-angiogenic drugs or tumor-targeting drugs with anti-tumor activity.
* Patients who have taken part in any clinical trial (interventional) during the study period.