cyrilzakka/clinical-trials huggingface dataset:
RESPOND Post Market Study

The purpose of the RESPOND post market study is to collect real world clinical and device performance outcomes data with the Lotus Valve System used in routine clinical practice to demonstrate that the commercially available Lotus Valve System is a safe and effective treatment for patients with severe calcific aortic stenosis.

The RESPOND study is a prospective, open label, single arm, multi-center, observational post market study designed to collect real world clinical and device performance outcomes data of the commercially available Lotus Valve used in routine clinical practice for the treatment of severe calcific aortic stenosis. Approximately 1000 real-world, consecutive subjects will be enrolled at up to 50 study centers in Europe, Asia Pacific and Central/South America.

All enrolled subjects will be contacted for follow-up at 30 days, 1, 2, 3, 4 and 5 years post index valve implantation. Follow-up visit at 1 year post valve implantation should be conducted via outpatient clinic visit. Follow-up visits at 30 days and 2 through 5 years may be conducted in person (preferred) and via telephone interview. Subjects who are not implanted with a Lotus Valve will be followed for safety through 30 days after the initial attempted index procedure.

Collection of safety events will include any serious adverse event (SAE) that led to death, serious adverse device effect (SADE), adverse device effect (ADE), unanticipated serious adverse device effect (USADE), and all Valve Academic Research Consortium (VARC) events regardless of seriousness and device relationship through 5 year follow-up.

The RESPOND study will be conducted in accordance with the International Organization for Standardization (ISO) 14155: 2011; ethical principles that have their origins in the Declaration of Helsinki; the relevant parts of the International Conference on Harmonization (ICH) Guidelines for Good Clinical Practices (GCP); and pertinent individual country/state/local laws and regulations.

An additional cohort of approximately 50 subjects will be enrolled at up to 6 study centers in Europe after enrollment in the main cohort is completed to assess center-driven implantation technique with the commercially available Lotus Valve with Depth Guard technology.

Eligibility Criteria:
Subjects will be evaluated for eligibility by the clinical center's heart team per the local standard of practice in accordance with the Directions for Use.
Na+ Channel mRNA Regulation in Heart Failure

Human heart failure (HF) has been associated with reduced cardiac sodium channel current and other electrical remodeling. Recently, the investigators have shown that downregulation of cardiac Na+ channels (SCN5A) can contribute to arrhythmic risk and that upregulation can mitigate that risk. Furthermore, the investigators have shown that the reduction in cardiac SCN5A mRNA abundance is reflected in circulating white blood cells (WBCs), which also express SCN5A, and that a reduction in SCN5A is highly predictive of appropriate implanted cardiac defibrillator (ICD) therapy. These data suggest that SCN5A regulation contributes to arrhythmic risk in HF. Other electrical remodeling events thought to contribute to arrhythmic risk include reductions in K+ currents, including Ito, IK1 and IKs are responsible. These current reductions have been linked to reduced transcription, translation and expression of the corresponding channel subunits, such as Kv4.3, Kir2.1, KvLQT1, and accessory proteins including minK and K+ channel interacting protein 2. That all these ion channels are downregulated may suggest a common mechanism to reduce ion channel expression. In this application, the investigators intend to explore an entirely novel mechanism by which SCN5A and other ion channel mRNA abundances are reduced in HF.

Altered gene expression has been traditionally focused on transcriptional regulation. Nevertheless, recent large-scale analyses have revealed that as many as half of all changes in the amounts of mRNA in responses to cellular signals can be attributed to altered rates of mRNA decay. In preliminary data, we show that HuR, a member of a class of RNA stabilizing proteins that bind to AU-rich elements (ARE), is expressed in the heart and contributes to Na+ channel mRNA stability by binding to SCN5A transcript. Furthermore, HuR appears to be downregulated in human HF, perhaps contributing to the downregulation of ion channels and increased arrhythmic risk seen in HF. We propose that HuR is downregulated in HF, that this downregulation contributes to reduced Na+ and other currents and increased arrhythmic risk, and that upregulation of HuR will reduce ion channel downregulations and arrhythmic risk in HF. The investigators specific aims are:

Aim 1: Determine the extent to which HuR can regulate ion currents in cardiomyocytes.

Aim 2: Determine the relative contributions of known ion channel posttranscriptional control mechanisms.

Aim 3: Determine the mechanism and extent to which HuR activity is downregulated in ischemic and nonischemic cardiomyopathy and the correlation with ion channel mRNA, protein, and current.

Aim 4: Determine the extent to which overexpression of HuR can raise ion channel mRNA, raise ion channel current, and reduce arrhythmic risk in ischemic and nonischemic cardiomyopathy.

Please be notified that only Aim 2 involves the usage of de-identified human heart samples.

Eligibility Criteria:
Inclusion Criteria:

* ischemic or non-ischemic cardiomyopathy Healthy Donor heart

Exclusion Criteria: N/A

* Not diagnosed with ischemic or non-ischemic cardiomyopathy
An Open-Label Study to Investigate the Safety of Single and Multiple Ascending Doses in Children and Adolescents With Dravet Syndrome

Stoke Therapeutics is evaluating the safety and tolerability of single and multiple ascending doses of STK-001 in patients with Dravet syndrome. Change in seizure frequency, overall clinical status, and quality of life will be measured as secondary endpoints in this open-label study.

STK-001 is an investigational new medicine for the treatment of Dravet syndrome. STK-001 is an antisense oligonucleotide (ASO) that is intended to increase the level of productive SCN1A messenger RNA (mRNA) and consequently increase the expression of the sodium channel Nav1.1 protein. This RNA-based approach is not gene therapy, but rather RNA modulation, as it does not manipulate nor insert genetic deoxyribonucleic acid (DNA).

STK-001 is designed to upregulate Nav1.1 protein expression from the nonmutant (wild-type) copy of the SCN1A gene to restore physiological Nav1.1 levels. Nav1.1 levels are reduced in people with Dravet syndrome. Stoke has generated preclinical data demonstrating proof-of-mechanism for STK-001.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Dravet Syndrome (DS) with onset of recurrent focal motor or hemiconvulsive or generalized tonic-clonic seizures prior to 12 months of age, which are often prolonged and triggered by hyperthermia.

  * No history of causal MRI lesion
  * No other known etiology
  * Normal development at seizure onset.
* Documented pathogenic, likely pathogenic variant, or variant of uncertain significance in the SCN1A gene associated with DS.
* Use of at least 2 prior treatments for epilepsy that either had lack of adequate seizure control (requiring an additional AED) or had to be discontinued due to an AE(s).
* Currently taking at least one AED at a dose which has been stable for at least 4 weeks prior to Screening.
* Stable epilepsy medications or interventions for epilepsy (including ketogenic diet or vagal nerve stimulator) for at least 4 weeks prior to Screening.

Exclusion Criteria:

* Known pathogenic mutation in another gene that causes epilepsy
* Currently treated with an AED acting primarily as a sodium channel blocker, as maintenance treatment, including: phenytoin, carbamazepine, oxcarbazepine, lamotrigine, lacosamide, or rufinamide.
* Clinically significant unstable medical conditions other than epilepsy.
* Clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to Screening or prior to dosing on Day 1, other than epilepsy.
* History of brain or spinal cord disease (other than epilepsy or DS), or history of bacterial meningitis or brain malformation
* Spinal deformity or other condition that may alter the free flow of cerebrospinal fluid (CSF) or has an implanted CSF drainage shunt.
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, may influence the results of the study, or may affect the patient's ability to participate in the study.
The Combined Usage of Clinical Physical Finding in Management of COVID 19 Patients

Physiological indicators such as blood pressure, heart rate, respiratory rate, and consciousness status of COVID-19 patients are used to apply the START (simple triage and rapid treatment, START), Modified Early Warning Score (MEWS), and quick Sequential Organ Failure Assessment (qSOFA) as tools for assessing clinical symptom tracking, deterioration, and subsequent improvement in COVID-19 patients. In response to the need for scarce manpower when a large number of emergency patients appear, a simple and easy-to-operate assessment method is adopted for mild patients, and artificial intelligence technology can be further used to assist in the assessment for early response and medication.

Due to the development of the pandemic , the virus has constantly mutated, leading to a vast majority of mild cases. This has significantly increased the burden on medical personnel. The investigators are trying to find a way to track whether their clinical symptoms have worsened. At the same time, the investigators want to know the changes in patient symptoms in real-time through online monitoring This is a single-center retrospective study of a group of COVID-19 patients. Review their medical records, mainly based on hospital field records and existing physiological indicators of patients such as blood pressure, heart rate, respiratory rate, and consciousness status. The partients visited the hospital between March 2020 and September 2022. All patients were given physiological value indicators MEWS, qSOFA, and START for scoring and assess the clinical symptom deterioration of COVID-19 patients.

In this study, The investigators collect the physiological values of each patient and the data on the nursing records during hospitalization to judge whether the symptoms have worsened

Eligibility Criteria:
Inclusion Criteria:

* a group of hospitalized COVID 19 patients were treated in the hospital between March 2020 and Sep.2022

Exclusion Criteria: Exclude patients who lack information in their medical records and incomplete clinical data.

-
Evaluation of Biomarker Levels in Gingival Crevicular Fluid of Patients With Different Periodontal Diseases

Objectives: The aim of this study is; detection of peptidyl arginine deiminase4 (PAD4), galectin-3 and tumor necrosis factor alpha (TNF-α) levels in gingival crevicular fluid (GCF) samples of periodontally healthy, gingivitis and periodontitis patients and the possible correlation between these values and clinical parameters of periodontal diseases. Materials and methods: Samples of GCF were obtained from 60systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20). Full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were also recorded. Enzyme-linked immunosorbent assay (ELISA) was used to determine PAD4, galectin-3 and TNF-α levels in the biological samples.


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.)
* At least twenty permanent teeth in the mouth
* Non-smoker
* No medication for continuous use
* Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months.
* Not in pregnancy or lactation period.
* For the periodontitis group that has not received periodontal treatment in the last 6 months
* For the periodontitis group; According to the evaluation made in 6 regions of each tooth, individuals with 30% or more bleeding on probing area, at least 2 teeth not adjacent to each quarter jaw with a depth of 5 mm or more and 4 mm or more attachment loss, coronal 1/3 and more on radiography (horizontal and / or vertical) bone loss
* For the gingivitis group; According to the evaluation made in 6 regions of each tooth, individuals with 10% or more bleeding on probing area, having a probing depth of less than 4mm and no attachment loss
* For healthy group; According to the evaluation made in 6 regions of each tooth,individuals with less than 10% bleeding on probing area, having a probing depth less than 4mm and no loss of attachment were included in the study.

Exclusion Criteria:

* Any oral or systemic disease
* Regularly using a systemic medication
* During pregnancy or lactation
* Received periodontal treatment within the last 6 months.
* Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months
* Smokers are not included in the study
Medtronic Closed-Loop Spinal Cord Stimulation System

The purpose of the study is to further understand the closed-loop feature in chronically implanted patients by characterizing the efficacy of the next generation, spinal cord stimulator.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Candidate is undergoing Medtronic SCS device trial for chronic, intractable pain of the trunk and/or limbs
* If being treated for low-back and/or leg pain,

  * the baseline overall\^ Visual Analog Scale is ≥ 60 mm and
  * baseline back and/or leg pain Visual Analog Scale is ≥60 mm. \^Average overall pain in the back and/or leg in the 72 hours prior to the baseline visit, measured using Visual Analog Scale.
* If being treated for upper limb pain - baseline Visual Analog Scale is ≥ 60 mm for upper limb pain
* On stable (no change in dose, route, or frequency) prescribed pain medications being used for back and leg pain or upper limb pain, as determined by the investigator, for at least 28 days prior to device trial
* Willing and able to provide signed and dated informed consent
* Willing and able to comply with all study procedures and visits

Exclusion Criteria:

* Indicated for an SCS device to treat stable intractable Angina Pectoris or Peripheral Vascular Disease of Fontaine Stage III or higher
* Previously trialed or implanted with spinal cord stimulator, peripheral or vagus nerve stimulator, deep brain stimulator or an implantable intrathecal drug delivery system
* Currently participating, or plans to participate, in another investigational study unless written approval is provided by the Medtronic study team
* Major psychiatric comorbidity or other progressive diseases that may confound study results, as determined by the Investigator
* Serious drug-related behavioral issues (e.g. alcohol dependency, illegal substance abuse), as determined by the Investigator
* Pregnant or planning on becoming pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal)
* Be involved in an injury claim or under current litigation
Effectiveness and Safety of Atelocollagen in the Management of Chronic Non-specific Low Back Pain

The purpose of this study was to evaluate the effectiveness and safety of atelocollagen in the management of chronic low back pain with sarcopenia due to degenerative changes.

Patients with chronic low back pain are enrolled and divided into group A (atelocollagen) and group B (control) through randomization after obtaining informed consent.

Investigators record tender points for the multifidus, erector spinae, and quadratus lumborum muscles by physical examination.

Investigators evaluate each muscle using ultrasound according to the assignment of each group, and apply atelocollagen mixture (atelocollagen 3 mL + 1% lidocaine 3 mL) or local anesthetics only (normal saline 3 mL + 1% lidocaine 3 mL) to each muscle on both sides.

The subject of the study performs a total of 3 injections at intervals of 2 weeks, and each measurement variable is collected by visiting 4 weeks and 12 weeks after the last injection.

Changing medications or additive interventions are not allowed before 4 weeks after last injection. Only acetaminophen is allowed as a rescue drug.

Eligibility Criteria:
Inclusion Criteria:

- Non-specific low back pain with persistent paraspinal tenderness of NRS 4 or higher despite conservative treatment (including physical therapy, exercise therapy, oral drug administration, and epidural block) for at least 3 months.

Adults 19 years of age or older

Exclusion Criteria:

- Systemic or local infection Coagulopathy Patients whose structure is difficult to confirm on ultrasound due to significant deformity of the lumbar spine Neoplasm of spine Cognitive disorder Patients with hypersensitivity to local anesthetics or amide-based local anesthetics Patients those who are allergic to or sensitive to atelocollagen ingredients or pork Women who are pregnant, lactating, or planning to become pregnant during the clinical period, or women of childbearing age who are not using available contraceptive methods Those who participated in other clinical trials within 30 days prior to screening or 5 times the half-life of the investigational drug in the clinical trial in which they participated, whichever is longer, whichever is longer Patients with serious systemic diseases
Evaluation of a Therapeutic Mobile App for Depression

The purpose of this study is a preliminary evaluation of a gamified attention bias modification training (GAMBT) for reducing symptoms of depression and rumination. Individuals with elevated symptoms of depression will use the digital intervention over the course of 4 weeks. They will complete a brief (\~5 question) survey daily, as well as weekly assessments.

This study aims to assess the feasibility and efficacy of the digital therapeutic attention bias modification (ABM) intervention that targets and reduces negative attention bias among adults with elevated symptoms of depression. Consistent with the experimental therapeutics approach ABM has been shown to both reduce negative attention bias and improve symptoms of depression. However, engagement with these tasks have been mixed, with some participants describing traditional ABM tasks as boring. This had led to the development of gamified versions of ABM with the intent to improve participant engagement. Nevertheless, there have been very few rigorous trials of ABM for depression, and no one to our knowledge has used ecological momentary assessment to tease apart the mechanisms by which ABM can lead to improvements in depression symptoms.

Participants will access the intervention on their mobile smart phone and complete treatment over a period of 4 weeks. Enrolled participants will be randomly assigned to one of two groups: Gamified attention bias modification training, or gamified placebo training. They will complete brief (\~5 questions) daily surveys, as well as weekly remote assessments of attention bias and depression symptoms.

Eligibility Criteria:
Inclusion Criteria:

* able and willing to provide informed consent;
* fluent in English;
* normal or corrected-to-normal vision
* moderate or greater depression symptoms (defined as greater than or equal to 10 on the PHQ-8);
* attention bias for negative stimuli (operationalized as greater than an average of 6500 ms of dwell time on sad faces in an attention bias task);
* stable psychiatric and neurological medication usage.
* access to a smartphone for downloading the app and a laptop or desktop computer to complete the weekly assessments

Exclusion Criteria:

* recent heavy alcohol use defined as a score of 2 or higher on the PDSQ
* past or present comorbidity of other serious mental illness (e.g., schizophrenia, substance use disorder, bipolar disorder, etc.)
* previous experience with gamified attention bias modification app
Study of the Effectiveness of The COVID-19 Vaccine

This descriptive study examines neutralizing antibody levels against COVID-19 in health workers before and after the 2nd booster of the COVID-19 vaccine in Surakarta, Indonesia.

This research is a cross-sectional study with a descriptive-analytic design, community-based, of adults who live in Surakarta (age 18 years and over) using the Google form. The inclusion criteria were health workers receiving the third or second dose of the COVID-19 vaccine. Quantitative antibody titers are checked at Prodia's laboratory. Other variables examined were the number and date of vaccination, age, sex, comorbid diseases, body mass index, AEFI symptoms after the vaccine, and history of being infected with COVID-19. In the statistical analysis using the different and regression correlation tests, the significance level of P is less than 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Health workers who receive the second booster of COVID-19 vaccination

Exclusion Criteria:

* Pregnancy
Promoting Resiliency Among Lymphoma Survivors: The 3RP-Lymphoma

The Relaxation Response Resiliency Program (3RP) was developed by researchers at the MGH Benson-Henry Institute for Mind Body Medicine; This program has recently been adapted to target the needs of individuals who have completed treatment for lymphoma (3RP-Lymphoma).

The Relaxation Response Resiliency Program, or 3RP, was developed by researchers at the MGH Benson-Henry Institute for Mind Body Medicine. The 3RP is a group program that-through a variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress and promote psychological resiliency and physical well-being.

The 3RP has not yet been carried out with individuals who have recently completed treatment for lymphoma. As such, the investigators have adapted the standard 3RP program to target the specific needs of lymphoma patients who are transitioning off active treatment. The investigators are conducting this study to see if the adapted program, the 3RP-Lymphoma, is effective at reducing stress and stress-related symptoms for people who have completed treatment for lymphoma within the past two years. To develop the 3RP-Lymphoma, the investigators conducted interviews with patients who had recently completed treatment to learn about their experiences and their preferences for topics they would want to include in a program tailored to their specific needs. The current phase of the feasibility study will examine if the adapted program is feasible, acceptable, and helps promote stress management among lymphoma survivors who are in the early stages of completing cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-64
* Within 2 years post-treatment completion for lymphoma
* English speaking
* Able and willing to provide informed consent
* Cancer treatment or follow-up for lymphoma at the MGH Cancer Center

Exclusion Criteria:

* Unwilling or unable to participate in the study
* Unable to speak or read English
* Is medically, psychiatrically, or otherwise unable to participate (as determined by a physician or study PI)
* Unwilling or unable to participate in group 3RP sessions delivered via the Partners Telehealth videoconferencing software
* Participation in qualitative interview during Phase 1 (DF/HCC 16-396)