cyrilzakka/clinical-trials huggingface dataset:
Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis (NASH)

This is a Phase 2 multi-center, randomized, single-blind, placebo-controlled study to evaluate the safety and efficacy of TVB-2640 in subjects with non-alcoholic steatohepatitis (NASH), a type of fatty liver disease. Subjects will be randomly assigned to 1 of 2 treatment groups (TVB-2640 at one of three doses or placebo). Following randomization, subjects will begin the 12-week treatment period and will receive once daily TVB-2640 or placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 18 years with a body mass index (BMI) ≤40 kg/m2.
2. Prior liver biopsy within 24 months of randomization with fibrosis Stage 1 to 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:

   * Steatosis
   * Ballooning degeneration
   * Lobular inflammation

AND

* Confirmation of ≥ 8% liver fat content on MRI-PDFF.

OR, if prior biopsy is not available:

* Either overweight or obese or diabetic or ALT ≥ 30 U/L or fatty liver on ultrasound and at least one more feature of metabolic syndrome by Adult Treatment Panel III (ATP III) criteria.

AND

* Magnetic resonance elastography (MRE) ≥ 2.5 kPa and MRI-PDFF ≥ 8% during screening.

Exclusion Criteria:

Subjects meeting any of the following criteria are not eligible for enrollment in the study.

1. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening.

   Note: Significant alcohol consumption is defined as average of \> 20 g/day in female subjects and \> 30 g/day in male subjects.
2. Type 1 diabetes.
3. Uncontrolled Type 2 diabetes defined as:

   * HbA1c ≥ 9.5% during screening. (Subjects with HbA1c ≥ 9.5% may be rescreened).
   * Basal insulin dose adjustment \> 10% within 60 days prior to enrollment.
   * Requirement for glucagon-like peptide analogue or a complex oral anti-diabetic (OAD) regimen (3 or more OADs) within 6 months of screening.
   * History of severe hypoglycemia (symptomatic hypoglycemia requiring outside assistance to regain normal neurologic status) within the previous year.

   Note: Individual diabetes regimens will be reviewed by Investigator and may be adjusted based on American Diabetes Association guidelines.
4. Presence of cirrhosis on liver biopsy (Stage 4 fibrosis) or imaging.
Decompensation Detection Study

To gather data and analyze decompensation events.


Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with an approved Guidant CRT-D HF device programmed to CRT therapy in VDD or DDD mode.
* Patients prescribed to the LATITUDE(R) system configured for at least weekly device interrogations and symptoms reporting.
* Patients willing to use the LATITUDE(R) enabled weight scale.

Exclusion Criteria:

* Patients that require adaptive rate pacing (rate-responsive modes).
* Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days.
* Both
Changes of Tear-film Lipid Layer Thickness and Ocular Aberration After Treatment of Meibomian Gland Dysfunction

In this study, investigator aim to evaluate the changes of tear-film lipid layer thickness and ocular aberration after treatment of meibomian gland dysfunction. In case of stage 3 or 4 meibomian gland dysfunction, participants will be treated using conventional treatment modalities. Before treatment and after 1 and 2 months of treatment, a variety of ophthalmic examination, tear-film lipid layer thickness, and ocular aberration are going to measured and compared.


Eligibility Criteria:
Inclusion Criteria:

1. age over 19 years old, with moderate to severe Meibomian gland dysfunction.

Exclusion Criteria:

1. patients with history of previous ocular or intraocular surgery
2. ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease
3. history of intolerance or hypersensitivity to any component of the study medications
4. wearing contact lenses during the study period, presence of current punctal occlusion
5. pregnancy, lactating women, and children
Morphine Gel for Bedsores

This study tests the effectiveness of a morphine-containing gel for reducing pain caused by pressure ulcers, also known as bedsores or pressure sores. We will apply the gel containing morphine, or the gel alone, directly onto painful pressure ulcers and compare the results.

In this study, we will apply a morphine-containing gel (or placebo) directly onto painful pressure ulcers. We will take participants off of any opioid-containing medications upon entry into the study. This allows us to measure any morphine that may enter into the bloodstream from the topically applied gel.

The purpose of this study is to examine the efficacy of the gel for pressure ulcer analgesia, as well as the systemic absorption of morphine from the topically applied gel. We will document the amount of pain medications taken by participants to determine whether the gel decreases the need for these drugs.

Eligibility Criteria:
Inclusion Criteria:

* Presence of a Stage II pressure ulcer.
* Pressure ulcer must be painful.
* Primary Care physician must approve participation.
* Thinking ability must be clear and intact.
* Willing to change pain medication to oxycodone.

Exclusion Criteria:

* Allergy to morphine, oxycodone or intrasite gel.
* Use of codeine- or morphine-containing medications.
* Use of pain medications for anything other than the pressure ulcer.
Inspiratory Muscle Training With Normocapnic Hyperpnea in Chronic Obstructive Pulmonary Disease (COPD)

Many studies suggest that inspiratory muscles training by means of normocapnic hyperpnea improves exercise tolerance in healthy subjects. No information is available about the use of this training in COPD patients even if other methods (such as threshold loading and resistive loading) have been shown to be effective in terms of Inspiratory Muscle Function, Health-Related Quality of Life and Exercise Tolerance.

This study is designed to evaluate the effects of normocapnic hyperventilation by means of Spirotiger®, an instrument training the respiratory muscles, avoiding hypocapnia (using the methodology of isocapnic hyperpnoea)in COPD patients.


Eligibility Criteria:
Inclusion Criteria:

* COPD patients. All patients are at stable state, free from an exacerbation from at least 3 months.

Exclusion Criteria:

* COPD patients with a recent history of cardiovascular disease, neurologic disease and other diseases that would interfere with the training.
CD16+ Monocytes in Coronary Heart Disease (CHD)

Monocytes may be separated into phenotypically and functionally distinct cell types by the presence or absence of the lipopolysaccharide receptor CD14 and the Fcγ-receptor CD16. The investigators hypothesize that the total numbers of CD16+ monocytes are significantly related to cardiovascular outcome in patients with angiographically proven coronary heart disease.


Eligibility Criteria:
Inclusion Criteria:

* angiographically proven coronary heart disease
* Age \> 18 years

Exclusion Criteria:

* life expectancy \< 12 months
* inability to participate in the trial (to give written informed consent)
Identification of Stroke at the Emergency Medical Dispatch Center

A study to investigate how stroke is identified and whether FAST, face-arm-speech test, is used in the emergency medical dispatch centre in Stockholm. The study will also investigate when FAST is used, does it increase the identification of stroke? And if other factors can be identified as "markers" for more effective identification of stroke during the emergency call.

Transcribed alarm calls are read through and analyzed using a qualitative method. Meaningful units are identified, coded and categorized. A phenomenological analysis is also applied to a separate analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients who has called the emergency medical dispatch centre and also are diagnosed as stroke at Södersjukhuset during the study period.

Exclusion Criteria:

* Cases where needed documents and files are missing.
ASQ Scores of Transient Hypothyroxinemia of Prematurity

• Transient hypothyroxinemia of prematurity (THoP) is defined as free thyroxine (FT4) level is below the reference values despite normal TSH level in preterm infant. This study aims to evaluate the neurological development of infants with transient premature hypothyroxinemia (THoP).


Eligibility Criteria:
Inclusion Criteria:

* newborn infants who were born at 28-36 gestational weeks
* Infants who were hospitalized in the neonatal intensive care unit
* Infants with transient hypothyroxinemia of prematurity

Exclusion Criteria:

* Newborns with maternal thyroid disease,
* Severe intracranial issues,
* Chromosomal and congenital anomalies,
* Infants older than 36 gestational weeks
Piloting Y-AMBIENT: a Quality of Life Intervention for Young African American Breast Cancer Survivors

The purpose of this two-arm pilot RCT is to evaluate processes and preliminary outcomes of a targeted QOL intervention vs. an attention control among young AA survivors post-treatment for early (I-II) \& late (III) stage breast cancer.

Primary Objectives

I. Evaluate feasibility and acceptability of Y-AMBIENT and an attention control among young African American breast cancer survivors.

II. Explore the degree to which the Y-AMBIENT vs. attention control affects preliminary health-related outcomes among young African American (AA) survivors.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (Y-AMBIENT): Patients receive three themed education sessions over 1 hour each, written materials, and videos at month 1. Patients also participate in 3, 20 minutes telephone reinforcement calls to discuss how they are doing and discuss any concerns that they are still managing at months 2, 3, and 4.

ARM II (ATTENTION CONTROL): Patients receive three themed education sessions over 1 hour each, written materials, and videos at month 1. Patients also participate in 3, 20 minutes telephone reinforcement calls to discuss how they are doing and discuss any concerns that they are still managing at months 2, 3, and 4.

After completion of study, patients are followed up at 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Biologically born women
* Self-identify as AA
* Are aged 18 to 44 years on study entry
* Are diagnosed with breast cancer stage I-III
* Have completed treatment with chemotherapy and/or radiation for stage I-III breast cancer prior to study entry
* Are English- speaking
* Have telephone and internet access

Exclusion Criteria:

* Participation in formal survivorship navigation programs because they are associated with improved health- related outcomes, which could be a confounder
D-chiro-inositol and AUB

Patients with AUB will undergo 6-month treatment with D-chiro-inositol and will fill in questionnaires on AUB, with the evaluation of hormonal serum levels.


Eligibility Criteria:
Inclusion Criteria:

* AUB

Exclusion Criteria:

* Menopause
* Cancer diagnosis
* Atypical endometrial hyperplasia
* Uterine fibroids
* Heavy symptoms requiring pharmacological intervention
* Progestogens treatment in the six months before the study
* Inositol treatment in the six months before the study
Evaluation of a Community Health Worker (CHW)-Led Program

The investigators are comparing health care utilization claims data of Medicaid beneficiaries who participated in a CHW program led by three Medicaid health plans' salaried CHWs in the Cody Rouge neighborhood of Detroit, Michigan with eligible beneficiaries who were not invited to participate in the program but received usual health plan services.

This program evaluation examines the effectiveness, barriers and facilitators of implementing a geographically targeted program led by salaried CHWs from three Medicaid health plans in collaboration with the Detroit Health Department and Joy Southfield Community Development Corporation. Beneficiaries who reside in the Cody Rouge neighborhood and had more than 3 Emergency Department (ED) visits or at least 1 ambulatory care-sensitive hospitalization in the prior 12 months are randomized to the CHW program or to usual outreach from the health plans. CHWs reach out to eligible beneficiaries to provide a comprehensive assessment of health, behavioral, and social needs; link them to needed resources; and provide necessary follow-up. At 12- month follow up, health plan claims data on ED visits, ambulatory care-sensitive hospitalizations, primary care visits and all related costs will be compared between participants who participated in this program compared with other participants who would have been eligible but were not offered the program (with no effort to contact them).

The investigators hypothesize that patients enrolled in the CHW intervention will experience a reduction in acute care usage resulting in cost savings compared to those receiving usual health plan CHW outreach. This study is among the first to evaluate the impact on health care utilization of augmented services delivered by health plan CHWs for high-utilizing health plan members. This study will provide important information on the sustainability of future health plan CHW programs and provide insights into effective implementation of such programs.

Eligibility Criteria:
Inclusion Criteria:

* Either have had more than 3 ED visits in the prior 12 months, or at least 1 ambulatory care-sensitive hospitalization in the prior 12 months

Exclusion Criteria:

* None if they meet above criteria.
Screening for Atherotic Plaques by Ultrasound for Assessing Cardiovascular Risk

Cardiovascular disease is a common diagnosed and treated condition in private practices of primary health care. There is growing evidence that atherosclerotic plaques as predictors for stroke and heart attack are more prevalent than expected based on the clinical score in people with low risk for stroke and heart attack .

Diagnosing atherosclerotic plaques can help to decide if a lipid lowering therapy should be prescribed even if the clinical risk score is low or on the other hand if they can be observed even in high lipid levels.

Both common and proximal internal carotid arteries and both common femoral arteries (including bifurcations) were screened by ultrasound in patients who came for a check-up to a primary care practice with no known cardiovascular disease and low risk for stroke and heart attack according to the AGLA/GSLA risk score which is mostly used in Switzerland.

All patients agreed and gave written informed consent to be included in this study. Presence of plaques was defined as a focal carotid intima-media thickness \>0.5 cm on ultrasound. Screening was performed by a medical doctor (DP) certified for the procedure using the following ultrasound system: Toshiba Nemio XG, probe 7.5 MhZ.

Eligibility Criteria:
Inclusion Criteria:

* low cardiovascular risk assessed by the AGLA/GSLA-score

Exclusion Criteria:

* cardiovascular disease
Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit

The aim of this investigation is to compare the performance of two quantitative monitors utilized on post-anesthesia recovering patients. The ToFscan (Draeger Medical Inc., Telford, PA) represents one of the few standalone acceleromyography (AMG)-based quantitative monitors available for routine clinical use in the United States. The TetraGraph (Senzime AB, Uppsala, Sweden) is a standalone electromyography (EMG)-based quantitative monitor that recently received Conformité Européene (CE) approval. While both of these quantitative monitors can be utilized to guide intraoperative NMBA re-dosing and confirm recovery, they provide their objective data via drastically different techniques.


Eligibility Criteria:
Inclusion Criteria

* Age \> or = 18 years old
* Patients willing to participate and provide an informed consent
* Patients undergoing an elective surgical procedure that requires use of non-depolarizing NMBA agents administered intraoperatively.

Exclusion Criteria

* Patients with unilateral disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
* Patients with systemic neuromuscular diseases such as myasthenia gravis
* Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.
Resilience Insight Self Compassion and Empowerment (RISE) Pilot

The purpose of this pilot study is to determine whether the combination of the Corporate Athlete® Resilience (CAR) Training Program and follow-up psychoeducational group sessions has significant impact on nurses' resilience and stress mindset in their personal lives and their working environment. Knowledge from this study can be applied to interventions in the future to improve resilience behavior.

The ongoing nursing shortage in the U.S health care system is a multifaceted issue. One factor leading to the nursing shortage is high turnover, particularly among critical care nurses due to their experiences with stressful work environments, ethical dilemmas, and high rates of patient morbidity and mortality. There is also a high prevalence of psychological disorders, such as anxiety, depression, and Post Traumatic Stress Disorder (PTSD) among critical care nurses. Consequences of turnover and low nurse staffing include lower quality of care, lower patient satisfaction, increased medical errors, increased rates of health care associated infections, and higher 30-day mortality rates.

Resilience is defined as "the ability to adapt to life's ever-changing landscape and recover quickly from the stressors and potential stressors". It is a learned psychological characteristic that can be used to bounce back after disruption and successfully adapt to stressful work experiences in a positive manner.

The Corporate Athlete® Resilience (CAR) Training Program is a 1-day training program that uses a holistic approach that focuses on moving between stress and strategic recovery to help build resilience and enable higher performance.

Eligibility Criteria:
Inclusion Criteria:

1. Adult ≥ 18 years old.
2. Employed as a critical care nurse at Florida Hospital in an adult ICU, PICU, PCVICU, or Level 3 NICU.
3. Able to speak, read, and understand English fluently.
4. Able to provide informed consent.
5. Receive a high score of ≥ 27 on the Emotional Exhaustion domain and/or a high score of ≥ 13 on the Depersonalization domain of the Maslach Burnout Inventory (MBI) as part of Florida Hospital IRBNet #1234568.
6. Willing to attend a full-day training program at HPI on the designated training date.
7. Willing and able to comply with all study procedures and requirements for the duration of the study.

Exclusion Criteria:

1. At imminent risk of harm to themselves or others
Trial of Clopidogrel After Surgery for Coronary Artery Disease (CASCADE Trial)

The purpose of this study is to determine whether the combination of clopidogrel with aspirin prevents the development of blockages (atherosclerosis) in vein grafts one year after coronary artery bypass surgery (CABG) compared to aspirin alone.

Saphenous vein graft disease remains a major limitation of coronary artery bypass graft surgery (CABG). The process of saphenous vein intimal hyperplasia is mediated by platelet aggregation and begins just days after surgical revascularization. Subsequently, areas of intimal hyperplasia in turn develop graft atherosclerotic disease and its sequelae. Clopidogrel improves outcomes in patients with atherosclerotic disease, and is effective at reducing intimal hyperplasia in animal models of thrombosis. Therefore, the goal of this study will be to evaluate the efficacy of clopidogrel and aspirin therapy versus aspirin alone in the prevention of saphenous vein graft intimal hyperplasia following one year after CABG.

Patients undergoing multi-vessel CABG and in whom at least two saphenous vein grafts will be used are eligible for the study. Patients will be randomized to receive daily clopidogrel 75 mg or placebo, in addition to daily aspirin 162 mg, for the duration of one year starting as soon as postoperative bleeding has been ruled out on the day of surgery. At the end of one year, all patients will undergo coronary angiography and intravascular ultrasound assessment of one saphenous vein graft as selected by randomization. The study will be powered to test the hypothesis that clopidogrel and aspirin will reduce vein graft intimal hyperplasia by 20% compared to aspirin alone at one year following bypass surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary multi-vessel CABG with at least two saphenous vein grafts, with or without the use of cardiopulmonary bypass.

Exclusion Criteria:

* Emergency surgery
* Valve surgery
* Redo CABG
* Left ventricle ejection fraction \< 25%
* Serum creatinine \> 130 µmol/L
* Preoperative use of clopidogrel (with the exception of the current admission)
* Preoperative use of warfarin; allergy to aspirin or clopidogrel.
* History of cerebrovascular accident
* History of severe liver disease
* Morbid obesity
* Current malignancy
EGFR-TKIs Combine Chemotherapy as First-line Therapy for Patients With Advanced EGFR Mutation-positive NSCLC

The aim of this study was to compare the efficacy of EGFR-TKIs(Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors) treatment plus concurrent chemotherapy versus sequential treatment with EGFR-TKIs and chemotherapy in patients with EGFR(Epidermal Growth Factor Receptor)-mutant non-small-cell lung cancer (NSCLC).

This is an open-label, randomized, parallel-group controlled clinical trial, and the study subjects recruited in this study are NSCLC patients mutant for EGFR gene (19del or L858R).

Subjects in the concurrent therapy group were given EGFR-TKIs treatment plus concurrent chemotherapy. Patients in the sequential treatment group were assigned to sequential EGFR-TKIs followed by chemotherapy group, which received TKIs monotherapy and then chemotherapy alone after disease progression; and sequential chemotherapy followed by EGFR-TKIs treatment, which was given first-line chemotherapy for 4 to 6 cycles, followed by maintenance therapy with EGFR-TKIs.

The endpoint of this study included clinical efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* Stage Ⅳ EGFR mutation-positive NSCLC
* Initial therapy
* ECOG performance status 0-1

Exclusion Criteria:

* EGFR mutation-negative
* Previous systemic antitumour treatment
Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Comparison of 1 Megahertz Versus 3 Megahertz

Temporomandibular disorders (TMD) are a group of musculoskeletal and neuromuscular conditions that involve the temporomandibular joints, the masticatory muscles, and all associated tissues. These disorders are characterized by regional pain and limitation of mandibular range of motion. Pain-related TMD affects approximately 5% to 12% of the population and can affect individual's quality of life. The incidence is about 4 percent. Therapeutic ultrasound is a type of physical therapy that delivers energy via propagation of ultrasonic waves. One gap in knowledge is whether 1 megahertz (MHz) treating frequency has the same efficacy as treating with 3 MHz. This research proposes to test that.

See brief summary.

Eligibility Criteria:
Inclusion Criteria:

* Adult females
* Bilateral myalgia based on Diagnostic Criteria for TMD (DC-TMD) criteria
* An average pain of 5 or more on a 0 to 10 scale over the last 30 days.

Exclusion Criteria:

* A history or diagnosis of systemic musculoskeletal disorders or rheumatologic diseases (e.g. fibromyalgia, muscular atrophy).
* Certain conditions such as neoplasms or fractures.
* Neuropathies or neurological disorders.
* Currently taking muscle relaxants or analgesics.
* Undergone any form of physical therapy within the last 60 days.
* Severe bruxism requiring mouth-guard treatment.