cyrilzakka/clinical-trials huggingface dataset:
Raltegravir + Lamivudine/Abacavir in HIV/Tuberculosis Co-Infected Patients

The study will investigate whether combination antiretroviral therapy of raltegravir and 3TC/ABC is effective and safe to use in tuberculosis (TB)/HIV co-infected adults receiving rifabutin-containing, first-line antituberculous treatment.

Hypothesis:Combination antiretroviral therapy of raltegravir and 3TC/ABC and is effective and safe to use in tuberculosis (TB)/HIV co-infected adults receiving rifabutin-based first-line antituberculous treatment.

This is a phase IIIB/IV, open-label, multi-center, single-arm descriptive pilot study of the efficacy and safety of RAL BID in combination with ABC/3TC QD in antiretroviral-naïve HIV-1 infected individuals with a presumptive or confirmed diagnosis of tuberculosis, without planned comparative analyses.

A goal of 40 subjects will be enrolled from 3 sites in the Russian Federation, including in our site, and receive RAL BID + 3TC/ABC QD for 48 weeks.

This study will include screening, treatment and follow-up periods. Screening period up to 28 days includes initial visits at Day -28 (screening) and Day -14 (switch to rifabutin). The second visit will be required if patient is initially on rifampin-based TB regimen that will need to be switched to rifabutin-based regimen.

Patients receiving rifampin-containing TB therapy will be switched to rifabutin (300 mg daily) a minimum of 14 days prior to initiation of antiretroviral therapy. Patients must not have received more than 45 days of tuberculosis therapy.

Treatment period from Day 1 to Week 48 includes 7 visits and a follow-up period (2-4 weeks after the Week 48 visit or Withdrawal visit) includes one visit for resolution of ongoing AEs (adverse events) and new SAEs (serious adverse events). Patients will therefore have 10 scheduled assessments: screening (Day -28; Day -14), baseline (Day 1), Weeks 4, 8, 12, 24, 36, and 48, and follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* ART-naïve HIV infected patients
* Plasma HIV-1 RNA \>1,000 copies/mL at screening
* CD4 cells 100-350 cells/mm3
* Have presumptive or confirmed diagnosis of Mycobacterium tuberculosis infection
* Receiving first-line antituberculosis treatment
* Documented negative results for the presence of HLA-B\*5701 allele

Exclusion Criteria:

* Pregnancy and Breastfeeding
* Known allergy/sensitivity to study drugs or their formulations
* A condition (including but not limited to active alcohol or drug use) that, in the opinion of the investigator, may interfere with patient adherence or safety
Clinical Trial of Smoking Cessation Mobile Phone Program

The Sponsor is doing a research study to assess the effects of a smartphone program designed to help users smoke less and eventually quit. When participants join, their involvement in the core study will last 8 weeks. After 8 weeks, they will have the option to continue using the program to guide their quit journey or participate in follow-up research.

The overarching study aim is to recruit and enroll a population of current smokers who are motivated to quit with the assistance of a mobile solution.

The core study period will consist of 8 weeks of iPhone program usage. Comprehensive questionnaires will be given to the user during the course of their application usage. Users will receive notifications to link them to these online surveys, which will record their responses in a secure database. Following the 8-week core study, participants may continue usage of the program.

During the course of their use of the program, participants will be asked to provide information regarding three general areas on a regular basis as part of their use of the app: smoking status, adherence to self or physician-directed quit plans (including but not limited to medications for smoking cessation and over-the-counter quit aids), and overall user satisfaction. One way that the program assesses these areas involves asking users to answer questions addressing whether or not the user used nicotine in the last 24 hours. At the end of each week, users will also be asked to report their cigarette count for each of the past 7 days, using the standardized reporting technique called the Timeline Followback (TLFB) Method Assessment (Sobell, 1992).

At the 16-week mark and at the 24-week mark after enrollment, users will receive a brief questionnaire retrospectively looking at their cigarette usage, adherence to quit aids, and physical symptoms of nicotine withdrawal.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65
* Smokes at least 5 cigarettes daily
* Is interested in quitting in the next 30 days
* Owns an iPhone with iOS 8 or higher capabilities
* Willing and able to receive SMS text messages
* Able to comprehend the English-language and the informed consent form
* Lives in the United States
* Provides informed consent to participate in the study
* Able and willing to comply with study procedures as outlined in the protocol and informed consent form

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Responds appropriately to any item in the Eligibility Questionnaire:

  1. Do you smoke at least 5 cigarettes a day? - must say YES
  2. Are you interested in quitting in the next 30 days? - must say YES
  3. Do you have access to an Apple iPhone with iOS 8 (or higher) capabilities and internet access? - must say YES
  4. Are you between 18-65 years old? - must say YES
  5. Do you currently live in the United States? - must say YES
  6. Are you currently using a mobile phone-based smoking cessation intervention? - must say NO
  7. Are you willing and able to receive SMS messages throughout the study? - must say YES
Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects

This study will compare how well a combination of borage and echium oils will reduce inflammation compared to fish oils and placebo oil in subjects that are diabetic or have metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* adults, aged 21 years or more with either diabetes or metabolic syndrome. metabolic syndrome defined by NCEP/ATPIII criteria; must have 3 out of 5 of the following risk factors: 1.central obesity, men-greater than or equal to 40 inches, women-greater than or equal to 35 inches; 2.fasting blood TG greater than or equal to 150mg/dl or be taking TG lowering medications; 3. blood HDL cholesterol, men less than 40 mg/dl, women less than 50 mg/dl; 4. blood pressure greater than or equal to 130/85 or on HTN medication 5. fasting glucose greater than or equal to 100 mg/dl.
* participants on statins or glucose lowering drugs if dosages are stable for 3 months

Exclusion criteria

* children/young adults less than 21 years of age
* currently using anti-inflammatory drugs including NSAIDS, oral/IV steroids or injection antiinflammatory drugs(for RA), aspirin greater than 100mg/day
* taking leukotriene receptor antagonists ( montelukast), tylenol or nasal/inhaled steroids OK.
* currently using niacin, fibrates or fish oil
* blood pressure greater than 170/100
* HB1Ac greater than 10%
* TG greater than 500 mg/dl
* myocardial infarction/vascular surgery/stroke within the past year
* any stage II,III,IV heart failure
* prior cholecystectomy
* end stage renal disease
* BMI less than 23 or greater than 45
* pregnancy
* alcohol use greater than 14 drinks per week
* current self reported tobacco or illicit drug use
* intolerance or allergy to fish oil
* participants taking insulin on QD or BID doses, stable for 3 months
Long-term Study of ADVM-022 in Neovascular (Wet) AMD [OPTIC-EXT]

ADVM-022-07 is an observational long-term extension (OPTIC-EXT) study assessing safety and efficacy of ADVM-022 gene therapy product, in subjects with neovascular, or exudative (wet), age-related macular degeneration (nAMD).

ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product developed for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is a serious condition and the leading cause of blindness in the elderly. The available therapies for treating wet AMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. A one-time IVT administration of ADVM-022 has the potential to treat wet AMD by providing durable expression of therapeutic levels of intraocular anti-VEGF protein (aflibercept) and maintaining the vision of patients. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with wet AMD receiving anti-VEGF therapy in clinical practice.

ADVM-022-07 is an observational long-term extension (OPTIC-EXT) study assessing safety and efficacy of ADVM-022 gene therapy product, in subjects with neovascular, or exudative (wet), age-related macular degeneration (nAMD).

To evaluate potential long-term outcomes of ADVM-022, the OPTIC-EXT will follow subjects previously treated in the OPTIC parent study (Clinical Protocol No. ADVM-022-01 \[OPTIC\] (NCT03748784)). Subjects will roll over from the OPTIC parent study and will be followed for 3 additional years, following completion of the preceding 2-year assessment period in the OPTIC parent study. There is no investigational treatment administered in this study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who received a single dose of ADVM-022 at any dose in the OPTIC study
* Willing and able to provide informed consent

Exclusion Criteria:

* None
Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique

This is a prospective, controlled observational trial of patients undergoing clinically indicated cardiothoracic computed tomography (CT), including pulmonary or aortic angiography and coronary CT angiography (CCTA).

The development of a novel CT scanner capable of sequential or fast-pitch spiral techniques in most patients (Siemens Definition Flash) represents a potentially crucial technical innovation at a particularly critical juncture. National healthcare systems are under pressure to deliver accurate and cost-effective diagnosis of an increasing number of patients and CT angiography in various settings is a proven, highly accurate technique that has been shown to improve diagnostic efficiency and reduce the cost of care.

However, there has been increasing concern about the lifetime attributable risk of cancer from radiation related to diagnostic procedures. Such concern extends to other radiation-based procedures that contribute to the cumulative lifetime radiation exposure of patients. The Flash scanner holds the promise of substantially reducing exposure resulting from a variety of examinations.

The CT DOSE multicenter trial is therefore designed to validate the extent of dose reduction attendant to the use of the Flash scanner in cardiothoracic scanning, and to determine whether image quality is preserved in spite of significant dose reduction.

Eligibility Criteria:
Inclusion Criteria:

* Scans from patients undergoing clinically indicated pulmonary angiography, aortography and/or CCTA.
* Age greater than or equal to 18 years.

Exclusion Criteria:

* No exclusions
Scale-up the Introduction of Simulation Into Four New Health Professional Training Institutions in East and West Africa

Simulation based learning practice is limited in Sub-Saharan Africa. Experiences gained from our prior implementation in Phase I of this program show that simulation is feasible and significantly contributes to learning. However, the growth and sustainability of simulation methodologies in health training and service delivery institutions is subject to variability and institution specific factors. These factors may include but are not limited to ease of adoption of new technologies, human resources, space and institutional culture. These factors are likely to vary widely in Sub-Saharan Africa across countries and institutions.

It's not known how institutional factors will influence the introduction, adoption and sustainability of simulation methodologies in East and West African health training and service delivery institutions. We have partnered with four institutions in East and West Africa (in Uganda, Tanzania, and Nigeria) to learn about the process of introduction and scaling of simulation based learning in new frontiers.

The investigators in this proposal have partnered and propose to expand Simulation Based Learning to Lira University in northern Uganda, Busitema University in Eastern Uganda, the Catholic University of Health and Allied Sciences (CUHAS), Tanzania and University of Jos in Nigeria. All these health training and service institutions serve large rural and peri-urban populations with poor access to health care.

The investigators will engage the partners in the co-design of implementation plans to design solutions for the barriers to implementation that are anticipated, and ensure appropriate tailoring to the local context. The investigators will use a Train of trainers (ToT) Faculty development model and this will include web-based debrief mentorship using recorded debriefing sessions from real simulations at partner sites. These videos will be loaded onto a centralization server to facilitate peer-to-peer feedback using a quality of debriefing framework.

Based on the investigators' learning experience from Phase I of implementation, the team aims to develop two categories of simulation facilitators: 1) Simulation implementation faculty (SiF) and 2) Lead simulation faculty. Lead simulation faculty (LsF) will be trained at the Mbarara University of Science and Technology (MUST) simulation center of excellence and will receive support in assessing their sites' barriers and facilitators regarding the Sim intervention. The faculty trainees will undergo an intensive 1.5-day faculty development course followed by a 2-day placement at MUST sim center for mentored scenario execution practice.

Eligibility Criteria:
Inclusion Criteria:

* Health professions Institutions in East and West Africa in the Sim for life program
* Institutional commitment to adopt simulation based learning Faculty at these health professions institutions

Exclusion Criteria: Institutions outside East and West Africa Sim for life program

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DUOSTIM and AI: is There a Difference Between Oocyte Performance in the Follicular and Luteal Phases?

In vitro fertilization (IVF) has revolutionized assisted reproductive techniques, bringing hope to thousands of people seeking to fulfill their dream of parenthood. However, patients with low ovarian reserve face additional challenges, such as limited response to ovarian stimulation and difficulty in obtaining good-quality eggs. Innovative protocols such as Duostim (dual stimulation) have shown promise in these cases, allowing the maximum number of eggs to be retrieved in a short period of time. In addition, technological advances in the analysis of the quality of mature eggs, such as the use of the Magenta tool, are transforming the way specialists evaluate and select the best gametes to increase the chances of success. This article explores how these approaches complement each other, offering new possibilities for patients with low ovarian reserve and raising the standards of reproductive medicine.

The analysis of the two stimulation phases in a Duostim protocol for IVF using the Magenta tool may have significant clinical relevance, especially in the context of patients with low ovarian reserve or who require optimization in the number of embryos available in IVF cycles in a short period of time. The Magenta tool, being based on AI and machine learning, can identify patterns related to the quality of oocytes and embryos obtained in both phases. This can help determine if there are significant differences in embryo competence between oocytes collected in the follicular phase and the luteal phase. Magenta-powered analysis can provide robust data to validate the Duostim protocol, identify subgroups that benefit most from it, and promote greater clinical efficiency in IVF treatments, especially in challenging cases. This approach can revolutionize the way personalized protocols are designed and monitored to maximize reproductive success. The aim of this study is to compare the two phases of ovarian stimulation - follicular and luteal - in patients undergoing the Duostim protocol, using the Magenta tool for detailed analysis of mature eggs obtained in each phase. The research seeks to identify differences in oocyte quality between the two stages, as well as to evaluate the efficiency of the protocol in maximizing results in patients with low ovarian reserve.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing IVF with DUOSTIM protocol and Magenta analysis of mature eggs.

Exclusion Criteria:

* Canceled Duostim Magenta IVF cycles
A Study to Evaluate the Safety of DAYVIGO (Lemborexant) Tablets in Participants With Insomnia.

The purpose of the study is to evaluate the incidence of somnolence, parasomnia, narcoleptic symptoms, and suicidal ideation/suicidal behavior after administration of lemborexant (DAYVIGO) in daily practice.


Eligibility Criteria:
Inclusion Criteria:

1. Participants who are treated with lemborexant
2. Participants who provide consent for participation in the study
3. Participants who were registered in EDC by 14 days after DAYVIGO treatment initiation

Exclusion Criteria:

1. Participants who were enrolled in this study before obtaining informed consent of this study
2. Participants who were participating in a clinical trial at the time of this study
Effects of Daily Taurine Intake for 6 Months on Biological Age and Body Metabolism Indicators As Well As Physical Fitness in 55-75-year-old Women and Men

The goal of this clinical trial is to investigate the effect of taking 4 grams of taurine by older adults on aging processes over a period of 6 months. It will also check for effects of taurine on participant's physical fitness, metabolic and cognitive functions. The main question it aims to answer is:

• Does a supplementation with 4 g of taurine daily over a period of 6 months slow down biological aging in humans? Researchers will compare supplementation with taurine to a placebo (a look-alike substance that contains no drug) to reliably determine whether taurine has an effect.

Participants will:

* Take 4g of taurine or a placebo every day for 6 months
* Visit the study site 4 times for checkups and tests: for a screening visit, at the beginning of the intervention, after 8 and 24 weeks

Measurements performed during study visits:

* Biological age estimate via proteome analysis
* Organ age estimates (proteomics)
* DNA methylation
* Inflammatory biomarkers (CRP, cytokines)
* Metabolic variables: fasting blood glucose, insulin, HOMA-IR, HbA1c, lipids, BMI
* Physical fitness (hand grip strength, leg extensor strength, PWC130)
* Resting energy expenditure
* Cognitive function via questionnaire
* Quality of life
* Heart rate variability
* Physical activity, nutrition

Eligibility Criteria:
Inclusion Criteria:

* women or men
* Age 55 - 75
* BMI 22 - 30 kg/m²
* written consent

Exclusion Criteria:

* Acute or chronic inflammation (e.g. flu infection)
* Severe chronic illness (e.g., Type 1 or Type 2 diabetes mellitus, COPD, renal insufficiency)
* Myocardial infarction or stroke in the previous 6 months
* Psychiatric disorder, including depression or dementia
* Weight change of ≥ 5 kg in the last 6 months
Clinical Trial on Alzheimer Disease, Presbycusis and Hearing Aids

This is a 12-months' randomized clinical trial that aims at studying the benefit of bilateral hearing aids in hearing impaired patients suffering from a slight to moderate stage Alzheimer disease.

The benefit of this intervention will be studied in the cognitive, behavioural, quality of life and economic fields.

2groups are involved in this trial: Intervention group: 12 months' treatment with active hearing aids, fitted hearing impairment Control group: 6 months' treatment with placebo hearing aids, followed with 6 months' active hearing aids, fitted hearing impairment


Eligibility Criteria:
Inclusion Criteria:

* \> 65 year-old
* Medical diagnosis of Alzheimer disease
* 15 ≤ MMSE ≤ 25
* No hearing aids in the last 2 years
* Motivated caregiver living with the patient
* Sensorineural hearing loss

Exclusion Criteria:

* Beginning of an anticholinesterasic treatment in the last 6 months
* Change in the anticholinesterasic treatment in the last 2 months
Retrospective Study of Acute Chest Pain in Extremely Critical Condition for More Than Ten Years

Acute non-traumatic chest pain is a common kind of symptom in extremely critical condition, with various pathogenesis and different level of risk . Chest pain in high risk takes 1/3 of that. It mainly includes acute coronary syndrome (including myocardial infarction and unstable angina pectoris, accounted for over 95% of chest pain in high risk), aortic dissection, pulmonary embolism etc, and is in high lethality and deformity.

The investigators do the research :

1. To study the diagnosis and management condition of acute chest pain in extremely critical condition for last ten or more years in Qilu Hospital,Shandong University.
2. To discuss the significance of key accompanying symptoms(for example radiating pain, chest distress, sweating, nausea etc), physical signs and lab examination in early diagnosis and risk stratification of acute chest pain in extremely critical condition.
3. To study the effect factors of thrombus burden in STEMI patients, at the same time, creat a a simple, practical and scientific method of blood clots classification.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients of Qilu Hospital, whose electronic medical records were searched out by terms of acute myocardial infarction, aortic dissection, pulmonary embolism and unstable angina in International Classification of Diseases(ICD)-10 code from Jan.2003 to Sep.2015.

Exclusion Criteria:

* Patients whose medical records are false, omitted or uncompleted because of transference, death et al.
Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers

The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers.


Eligibility Criteria:
Inclusion Criteria:

* healthy normal, soft contact lens wearing volunteers
* normal ocular health
* contact lens correction from +6.00 to -12.00D in each eye and astigmatism of -1.00D or less in each eye

Exclusion Criteria:

* active ocular infection
* history of ocular surgery
* use of topical ophthalmic preparations (including rewetting drops)
* pregnancy or lactation