cyrilzakka/clinical-trials huggingface dataset:
Natrunix in HLA-B27 Positive Subjects With Axial Spondyloarthritis

Double-blind, placebo-controlled, randomized trial of Natrunix in combination with Standard of Care in patients with Axial Spondyloarthritis

This is Double-blind, placebo-controlled, randomized trial examining Natrunix in combination with Standard of Care. Qualified subjects will be consented and screened for study eligibility and enrollment. Enrolled subjects will be randomized in a 2:1 ratio to receive either 400 mg Natrunix or placebo. All subjects who enter the study must be on a stable background standard of care (SOC) that they were receiving for at least 8 weeks prior to study enrollment. Enrolled subjects must meet 2009 Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial spondyloarthritis, be HLA-B27 positive, and have active disease as defined by a BASDAI score ≥4 or an ASDAS-CRP \>2.1. Subjects will receive once weekly injection of Natrunix or placebo in addition to SOC for 12 weeks. The study will conclude after 12 weeks followed by a 12-week open label extension phase and one-week follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Positive for HLA-B27 and have at least 2 additional SpA features OR Positive for HLA-B27 and has radiological evidence of sacroiliitis from either X-ray or MRI from patient's medical records.
2. Must have active disease at screening, according to either Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), with disease severity of ≥ 4 or ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score - C Reactive Protein) ≥ 2.1
3. Subject must be DMARD naive, including those who previously declined DMARD treatment options, OR previously discontinued DMARD treatment after initial trial of no more than 12 total weeks

Exclusion Criteria:

1. History of treatment with Natrunix
2. Have received any prior, or are currently receiving, treatment with opiates, csDMARDS, biologic DMARDs, JAK inhibitors, or other immunomodulatory agents for more than 12 weeks at any point prior to enrollment OR within 12 weeks prior to enrollment
3. Treatment with more than one csDMARD (such as methotrexate and sulfasalazine etc.) , biologic DMARD (such as Etanercept and Infliximab etc.), JAK inhibitor (such as Tofacitinib and Upadacitinib etc.), or any combination thereof prior to enrollment Currently requiring regular dosing regimen corticosteroids (excluding PRN dosing) Treatment with biologics that target CD20 (Rituximab or any other anti-CD20 antibody) prior to enrollment
4. Clinically significant laboratory abnormalities per PI's discretion
5. Positive for active HIV, hepatitis B or C
Administration of Tadalafil in Patients With Benign Prostatic Hyperplasia

The aim of the present study is to evaluate the efficacy and safety of once daily administration PDE5 inhibitors, tadalafil for 3 months as anti-inflammatory, antiproliferative and relaxant effects in ED with BPH patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 45 years and sexually active with symptomatic benign prostatic hyperplasia (no hospitalization 3 months prior to start of treatment).

Exclusion Criteria:

* 1. Patients with bladder or prostate malignancy. 2. A history of lower urinary tract surgery. 3. History of catheterization. 4. Urinary retention. 5. Urinary tract infection. 6. Stone disease. 7. Any neurological disease.
Physical Activity-related Health Competence in Apprenticeship and Vocational Education

Although the health-promoting effects of physical activity are well known and apprentices often possess an insufficient amount of physical activity, there is a lack of interventions promoting physical activity in vocational education and training. Against this background, the PArC-AVE project uses a co-creation approach to develop and implement physical activity-promoting interventions tailored to the needs of the target group and the given setting in two vocational education and training institutions. The purpose of this study is to evaluate the effectiveness of the co-created interventions in vocational education and training, namely the BuG lesson in nursing care and the tutoring system in automotive mechatronics. Therefore, the investigators conducted two non-randomized controlled trials from October 2018 to September 2019.


Eligibility Criteria:
Inclusion Criteria:

* First-year apprentices from the automotive mechatronics and nursing care sectors

Exclusion Criteria:

* /
Trial of Levomilnacipran in Geriatric Depression

The purpose of this study is to examine the effects of levomilnacipran (FETZIMA) compared to placebo for the treatment of depression in older adults.

A 12-week pilot double-blind comparison of levomilnacipran (FETZIMA) to placebo for the treatment of geriatric depression. The investigators are interested in assessing the efficacy of levomilnacipran (LMIL) to placebo (PBO), and exploring the effects of antidepressant response on brain connectivity and neuroplasticity. This pilot study is designed to determine any differences in the efficacy, safety and tolerability of levomilnacipran compared to placebo, and to perform dose finding (20-120 mg per day) in 40 older depressed adults. The investigators anticipate that the LMIL will be superior to PBO in improving levels of depressive symptoms and rates of remission, as well as improving cognition, apathy, and quality of life. This proposal expands the investigator's focus on the biomarkers of neuroplasticity that have been used in several prior studies and demonstrated responsivity to antidepressant treatment. The purpose is to examine this directly in 40 older adults with major depression. This proposed trial will also serve as a pilot study to estimate the efficacy and tolerability of the drug in older depressed adults, and the dose-finding in this population.

Eligibility Criteria:
Inclusion Criteria:

* 60 years of age or older
* The presence of a major depressive disorder diagnosed according to the Diagnostic and Statistical Manual and Mental Disorders, 5th edition (DSM-V) criteria
* A 24-item Hamilton Rating Scale for Depression (HAMD) score of 16 or higher at baseline
* Mini-Mental State Exam (MMSE) score \> 24.

Exclusion Criteria:

Subjects will be excluded if they had 1) any current and/or lifetime history of other psychiatric disorders (except unipolar depression with or without comorbid generalized anxiety disorder), or 2) recent unstable medical or neurological disorders; 3) any disabilities preventing participation in the study or in the MRI; 4) diagnosis of dementia; 5) acute suicidality; 6) subjects with known allergic reactions to milnacipran, uncontrolled narrow angle glaucoma, seizures, poorly-controlled hypertension or ischemic changes on ECG, serotonin syndrome, or the recently used monoamine oxidase inhibitors (MAOIs) within last 4 weeks; 7) ineligible for MRI (e.g., metal in the body or claustrophobia)
Role of Anti-TREK-1 Autoantibodies in SCVF

Short-coupled ventricular fibrillation (SCVF) is a lethal, primary electrical disorder and an important cause of unexplained cardiac arrest.1 Recent work from our group suggests that a substantial proportion of SCVF cases is associated to circulating autoantibodies targeting TREK-1, a cardiac potassium channel, resulting in an abnormal gain-of-function which is the prerequisite for the SCVF phenotype.2 This proposal is a translational multicenter study to validate anti-TREK-1 autoantibodies as a diagnostic and prognostic biomarker in a large, diversified cohort of SCVF patients (Figure 1). Functional, cellular experiments in patient-derived hiPSC cardiomyocytes and Purkinje cells will be performed to explore the cell type-specific role of TREK-1 in arrhythmogenesis, while single-nuclear RNA sequencing (snRNA-seq) will allow us to establish the transcriptomic profile (Figure 1). These results will identify the cellular substrate for SCVF.

Please refer to the uploaded study protocol

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of SCVF as per current criteria
* Willingness to provide written informed consent

Exclusion Criteria:

- SCVF patients \< age 18
ESGE-Quality Improvement in Endoscopy: ERCP

The primary aim of the present study is to compare the incidence of post-ERCP pancreatitis (PEP) before and after the implementation of the QIC-guideline in 2017: "Performance measures for ERCP and endoscopic ultrasound: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative".

In 2017, a new guideline addressing the quality in ERCP entitled "Performance measures for ERCP and endoscopic ultrasound: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative" was published. The focus of the quality improvement committee (QIC) of the ESGE is to ensure high standard of all endoscopy examinations throughout Europe by adhering to quality-improving factors (key performance indicators and minor performance indicators as defined by the ESGE).

The study shall provide the investigators with information whether the introduction of the quality performance measures adopted by the European Society of Endoscopy (ESGE) will actually lead to an improvement in quality.

The study will compare the quality development in endoscopy based on following time intervals:

1. before introduction of the QIC-initiative (before 2017)
2. after the introduction of the initiative (2017-2023) (both retrospective data),
3. prospectively, from 2024 onwards.

The primary endpoint of this study will be the key performance indicator post-ERCP pancreatitis (PEP). In the ESGE-guideline, a minimum standard of \<10% and a target standard of \<5% was recommended. Different studies described the incidence of post-ERCP pancreatitis between 3,47% and 10,2%.

The investigators hope that this study will lead to even greater patient safety in the future by improving findings and examination quality and therefore reduce the incidence of post-ERCP pancreatitis. In addition, the aim is to harmonize the high endoscopic standards throughout Europe.

Eligibility Criteria:
Inclusion Criteria:nclusion criteria Individuals eligible for inclusion are patients referred for ERCP who do not fulfill one of the following exclusion criteria

Exclusion criteria

* Individuals eligible for inclusion are patients referred for ERCP who do not fulfill one of the following exclusion criteria
* Age under 18 years
* Inability to understand information for participation
* Refusal of participation, missing cooperativity, e.g., due to age or disease
* Pregnant or lactating patients
* Patients with \> 1 ERCP during the hospital stay: only the initial ERCP will be evaluated

Exclusion Criteria:

-
Sequential Left Prefrontal Repetitive Transcranial Magnetic Stimulation, With High Frequency, for Treatment-Resistant Depression

Sequential left prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS), with high frequency, for Treatment-Resistant Depression have been shown to have antidepressant effects. but doubts remain about the magnitude of previously demonstrated treatment effects.The aim of this study is To test whether daily weekday left prefrontal rTMS safely and effectively treats Resistant Depression disorder compared to sham controls.

Design:

Prospective, randomized, active sham-controlled (1:1 randomization), duration-adaptive design with 3 weeks of daily weekday treatment (fixed-dose phase) followed by continued blinded treatment for up to another 3 weeks in improvers.

Setting:

University psychiatric hospitals in Tehran including Roozbeh Hospital, Rasool Hospital and Imam Hossein General Hospital will refer clients to Iranian National Center for Addiction Studies, Tehran University of Medical Sciences.

Patients:

About 60 patients with unipolar nonpsychotic major depressive disorder, according to DSM-IV, resistant to treatment.

INTERVENTION:

We delivered rTMS to the left prefrontal cortex at 120% motor threshold (10 Hz, 4-second train duration, and 26-second intertrain interval) for 37.5 minutes (3000 pulses per session) using a figure-eight solid-core coil. Sham rTMS used a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of major depression
* Resistance to treatment as defined by the insufficient clinical benefit to at least one adequate medication trials

Exclusion Criteria:

* Other current Axis I disorders (except simple phobia and nicotine addiction)
* Personal or close family history of seizure disorder
* Ferromagnetic material in body or close to head
* Neurologic disorder
* Pregnancy
* Taking medications known to lower seizure threshold (eg, theophylline)
Effectiveness of Pharmaceutical Interventions in Hospitalized Patients

The presence of multimorbidities is very common among the elderly, which become major consumers of medicines. The process of prescribing medicines for the elderly should be done with caution, as the use of some medications may present more risks than benefits in this range age. Potentially inappropriate prescribing for the elderly has become a global concern for the promotion of an adequate pharmacotherapy, it becomes essential to be aware of the effectiveness and safety of medicines and the knowledge of which drugs whose risks of serious adverse reactions outweigh the benefit of your referral. In this sense, the present study has aim to evaluate the effectiveness of pharmaceutical interventions in frequency of omission of drugs with proven efficacy for cardiovascular diseases and promotion of treatment prescription inappropriate and polypharmacy. A prospective quasi experimental before and after study will be carried out in elderly patients diagnosed with cardiovascular disease admitted to the Ana Nery hospital, Salvador, Bahia, Brazil. A convenience sample will be collected, the data will be released and revised in a database built in the SPSS software and analyzed in the program statistic R and SPSS. At the end of the study, it is expected a decrease in the frequency of omission of medications and promotion of prescription drugs inappropriate.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cardiovascular disease
* Discharge after 24 hours

Exclusion Criteria:

\* Death
Taurolidine Lock in Long Term Parenteral Nutrition

Taurolidine alone or in combination with citrate have been proposed for locking the catheter to reduce the number of catheter infections. As there is not enough evidence to give recommendations in this regard, the study tested the hipothesis that taurolidine improves the outcome of long term paretneral nutrition.


Eligibility Criteria:
Inclusion Criteria:

* home parenteral nutrition for at least months before enrollment
* presence of central venous cathter

Exclusion Criteria:

* home nutrition \< 12 months
* catheter in peripheral vein
Nasal Irritation Study: Individual Factors in Nasal Irritant Sensitivity

This study seeks to document differences in nasal irritant sensitivity within the population. The investigators are interested in knowing whether age, gender, and allergy status (nasal allergies) predict nasal irritant sensitivity. This is important in understanding symptom reporting patterns in air pollution situations (particularly in so-called "problem buildings"), as well as in understanding the reflex mechanism of a response of the nose to irritants (e.g., nasal congestion).


Eligibility Criteria:
Inclusion Criteria:

* Non-smokers
* 18-69 years of age
* With or without allergic rhinitis (hay fever)
* In good general health and with no prior history of asthma
Development and Validation of a Prognostic Score for Early Death in Head Injury Patients.

Traumatic brain injury (TBI) is a serious condition with high morbidity and mortality. The Glasgow score alone, assessed at the initial phase, is not enough to determine the prognosis.

The aim of this study is to define and to evaluate a prognostic score for early death based on clinical and CT-scan findings in an observational retrospective derivation cohort of patients hospitalized for traumatic brain injury.

This cohort will allow us to carry out a uni- and then multi-variate analysis so as to create a prognostic score for early death.

We will subsequently test this score in a prospective validation cohort.


Eligibility Criteria:
Inclusion Criteria:

Traumatic brain injury (PMSI code (Programme Médicalisation des Systèmes d'Information) S 06.70 and S 06.71) Age\>14 years Surviving more than 6h after the trauma Hospitalized in the traumatic brain injury intensive care unit and managed in accordance with international guidelines Who underwent a cerebral CT-scan

Exclusion Criteria:

Ongoing treatment with anticoagulants or antiplatelets Pregnant women Persons without national health insurance cover Children less than 15 years old Under guardianship.
Adverse Events of MRI With Abandoned Leads

The purpose of this study is to determine the safety and efficacy of MRI scanning in patients with fractured or abandoned endocardial leads. Specifically, the investigators aim to provide community-acquired data that can be used in Medicare and Medicaid coverage determinations and to investigate whether patients with fractured or abandoned leads can safely be scanned using an MRI and to evaluate the impact of MRI availability on patient care in this population. This study also aims to validate similar studies conducted by Mayo Clinic, the Hospital of the University of Pennsylvania and Johns Hopkins Medicine that employ MRI in the abandoned lead patient population.


Eligibility Criteria:
Inclusion criteria:

* Patients implanted with or without an ICD or pacemaker and with a fractured or an abandoned or non-functional endocardial lead, and who have a clinical need for MR imaging
* Patients are English or Spanish speaking and able to review and sign the consent

Exclusion criteria:

* Patients who complete the MRI standard screening form and are deemed inappropriate for MRI for any reason other than abandoned or fractured endocardial, or epicardial lead.
* Patients less than 18 years of age
Examining the Feasibility of Prolonged Ketone Concentrate Supplement Drink Consumption in Adults With Type 2 Diabetes

Brief Summary:

Ketones are a source of energy and signaling molecule that are produced by the body when not consuming any food or consistently eating a low-carbohydrate "keto" diet. Blood ketones can be used as a source of energy by the body, but they may also act as signals that impact how different cells in the body function.

Recently, ketone supplements have been developed that can be consumed as a drink. These supplements can raise blood ketones without having to fast or eat a "keto" diet. Previous studies have shown that these supplement drinks can lower blood sugar without having to make any other dietary changes. Drinking these ketone supplements may therefore be an effective strategy to improve blood sugar control and influence how cells function.

To find out if it is feasible for people with type 2 diabetes to drink these ketones supplements regularly over 90 days, we will compare between two groups in this study: one group that will be asked to drink ketone supplements, and one group that will be asked to drink a placebo supplement.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with type 2 diabetes by a physician at least 1 year prior
* stable use of glucose-lowering medications for at least three months
* must be able to read and understand English in order to complete the study questionnaires

Exclusion Criteria:

* competitively trained endurance athlete
* actively attempting to gain or lose weight
* having a history of mental illness or existing neurological disease
* having a history of cardiovascular events in the last two years, hypoglycemia, irritable bowel syndrome, or inflammatory bowel disease
* are currently taking SGLT2 inhibitors or insulin
* are using more than 2 classes of glucose-lowering medication
* currently following a ketogenic diet or regularly taking ketone supplements
* unable to commit to a 90-day trial
* being unable to follow remote guidance by internet or smartphone
* currently taking natural or over-the-counter supplements specifically designed to lower blood glucose (e.g., berberine, bitter melon)
The Effect of a Virtual Navigator on Colorectal Cancer Patient Empowerment

For individuals diagnosed with colorectal cancer, exposure to up-to-date cancer information and support as well as guidance to access the most appropriate health care services is crucial for cancer self-management and support. Timely access to high quality cancer information is suggested to contribute to patient empowerment - defined as the perception of being better able to manage illness demands. With the advent of the information age, individuals are increasingly turning to online health information resources. The use of rigorous web-based tools is found to be an engaging and convenient way to access health information, while being tailored to people's needs and preferences. The present study seeks to examine the effects of a recently developed high quality and person-centred web-based tool, the Oncology Interactive Navigator (OIN) on patients' empowerment as well as document its cost-effectiveness. Participants newly diagnosed with colorectal cancer will be randomly assigned to experimental or control groups with the former having unrestricted access to the OIN for 8 months. Participants in the control group will receive care as usual. Information on background, medical characteristics, and empowerment will be collected as well as cost-effectiveness indicators. If producing the desired effects, the OIN could be proposed for national implementation across Canadian cancer centers. Work is currently underway to add over 23 types of cancer diagnosis to the OIN.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed, first diagnosis of colorectal cancer (all stages)
* within 20 weeks of when the individual was told s/he has colorectal cancer
* fluent in English or French; able and willing to complete questionnaires
* unrestricted home Internet access
* has used the Internet at least once in the past
* informed consent

Exclusion Criteria:

* previous history of CRC at any time, or any other cancer diagnosed within the last 5 years (exception: superficial skin cancer)
* medical or severe health problem
* terminal phase of colorectal cancer or too sick to participate