cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study of Vitamin K2 (Menaquinone-7, Soloways ™) in Patients With Osteopenia/Osteoporosis Carrying a VDR Gene Variant

This pilot, genotype-stratified clinical trial aims to evaluate the safety and preliminary efficacy of vitamin K2 (menaquinone-7, MK-7) supplementation in patients with low bone mineral density (osteopenia or osteoporosis) who carry a specific "unfavorable" variant in the vitamin D receptor (VDR) gene (e.g., BsmI or ApaI polymorphisms). The trial will compare improvements in bone health and related biomarkers between two cohorts: (1) homozygous carriers of the VDR variant and (2) non-variant carriers (wild-type). Investigators hypothesize that MK-7 supplementation will lead to greater improvements in bone mineral density (BMD) and bone turnover markers in the homozygous variant group due to their potentially reduced baseline response to vitamin D signaling.

Vitamin D receptor (VDR) polymorphisms have been associated with varying responses to vitamin D and calcium supplementation, ultimately influencing bone health. Menaquinone-7 (vitamin K2) is crucial for carboxylation of osteocalcin, facilitating calcium deposition in bone. This study investigates whether individuals with an "unfavorable" VDR gene variant - who might have lower basal responsiveness to vitamin D - experience enhanced benefit from MK-7 supplementation in conjunction with a standard vitamin D3 regimen. By focusing on this genotype-stratified approach, the study aims to generate preliminary data supporting the role of personalized supplementation strategies in skeletal health.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 40-75 years with a confirmed DXA-based diagnosis of osteopenia or osteoporosis (T-score ≤ -1.0).
* Stable dietary habits and willingness to maintain current exercise regimen throughout the study.
* Willingness to undergo genotyping for the VDR variant. For the VDR Variant Cohort: confirmed homozygous "unfavorable" variant (e.g., BsmI or ApaI).
* For the Non-Variant Cohort: confirmed absence of the "unfavorable" allele (wild-type).

Exclusion Criteria:

* Current or recent (last 3 months) use of high-dose bisphosphonates, anabolic agents (e.g., teriparatide), or selective estrogen receptor modulators (SERMs). Known allergy or hypersensitivity to vitamin K or vitamin D supplements.
* Severe renal or hepatic dysfunction, uncontrolled hyperthyroidism, or other significant comorbidities that could confound bone metabolism assessments.
* Pregnancy or breastfeeding.
* Inability or unwillingness to provide informed consent or to comply with study procedures.
Stabilometric Assessment of Balance Recovery in Persons With Multiple Sclerosis

Background: Balance control relies on accurate perception of visual, somatosensory and vestibular cues. Sensory flow is impaired in Multiple Sclerosis (MS) and little is known about the ability of the sensory systems to adapt after neurological lesions reducing sensory impairment. The aims of the present study were to verify whether:

1. Balance rehabilitation administered in a challenging sensory conditions would improve stability in upright posture
2. the improvement in a treated sensory condition would transfer to a non treated sensory condition.

Methods: Fifty three persons with Multiple Sclerosis, median (min-max) Expanded Disability Status Scale score of 5 (2.5-6.5), participated in a Randomized Controlled Trial and were randomly assigned to two groups. The Experimental group received balance rehabilitation aimed at improving motor and sensory strategies. The Control group received rehabilitation treatment which did not include training of sensory strategies. Persons with Multiple Sclerosis were blindly assessed by means of a stabilometric platform with eyes open, eyes closed and dome, on both firm surface and foam. Anterior-posterior and medio-lateral sway, velocity of sway and the length of Center of Pressure (CoP) trajectory were calculated in the six sensory conditions.


Eligibility Criteria:
Inclusion Criteria:

* Clinically or laboratory definite relapsing-remitting, primary or secondary progressive MS

Exclusion Criteria:

* Inability to stand independently in upright position for 30 seconds
* Inability to walk for 6 m even with an assistive device
HIGH Altitude CArdiovascular REsearch Latin America Population Study

High blood pressure (BP) is one of the principal cardiovascular risk factors. While BP levels and hypertension prevalence are well characterized in many populations, information on BP and on cardiovascular risk profile in high altitude inhabitants is limited and frequently contradictory, especially in the large highland populations of South America. The information on the effects of permanent high altitude exposure on cardiovascular variables including BP may be relevant in the light of the known BP-increasing effect of acute exposure to high altitude hypoxia. This information may have practical implications for millions of people living at elevated altitudes in Asia, South America and Africa.

The inconclusive epidemiological evidence on BP and cardiovascular risk in high altitude dwellers may be the result of several factors, among them: 1) confounding by genetic and socio-economic factors; 2) imperfect methods of BP evaluation, in particular lack of data on ambulatory and home BP (both methods considered superior to conventional clinic BP in the assessment of exposure to high BP).

On this background, the general aim of the study is to compare blood pressure levels and cardiovascular risk profile among population-based samples of subjects residing in Peruvian communities living at different altitudes.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years) male and female subjects;
* Highlanders: permanence at high (\>2500 m) altitude;
* Lowlanders: permanence at low (\<1500 m) altitude;
* Written informed consent to participate in the study

Exclusion Criteria:

* Lowlanders who over 3 months preceding inclusion in the study spent considerable (\> 7 consecutive days) amount of time at altitudes above 1500 m;
* Highlanders who over 3 months preceding inclusion in the study spent considerable (\>7 consecutive days) amount of time at altitudes below 2500 m;
* Subjects cognitively incapable of providing informed consent or responding to a questionnaire
* Physical disability that would prevent study assessments from being performed
* Active pulmonary tuberculosis
* Pregnancy
Antibodies and Immunity After Vaccination of Recovered Patients With COVID-19 and Long COVID-19 Symptoms

We investigated the association between immune system responsibilities in Long COVID patients and Full recovery patients.

This retrospective cohort study compared immunogenicity post COVID-19 between individuals (aged 18-65 years and had confirmed SARS-CoV-2 infection from January to May 2022 ) with residual Long COVID-19 symptoms (LC) and ones with full recovery (Full) related to pathophysiology, immunology and clinical consequence.

Eligibility Criteria:
Inclusion Criteria:

* Long COVID group; at longer than 1-month post COVID-19 based the presence of one of the three following symptoms: fatigue/myalgia, breathlessness, and anorexia
* Full recovery group; patients with asymptomatic symptoms
* post COVID-19 they had not received any additional COVID vaccine

Exclusion Criteria:

* people who received additional vaccination after leaving quarantine before the day of the immunization test
* pregnant patients,
* people who had a history of allergic reactions after COVID-19 vaccination or any drugs
Implementation of the Care Ecosystem Training Model for Individuals With Dementia in a High-risk, Integrated Care Management

There is growing need for to provide high quality care for persons living with dementia (PLWD) and provide support for care partners in the primary care setting. The Care Ecosystem model is a telephone-based dementia care program that provides standardized, proactive, personalized, and scalable support and education for care partners. The Care Ecosystem model has demonstrated an improvement in patient quality of life, reduced unnecessary healthcare expenditures, and a decrease in care partner burden and depression.

In this pilot the investigators will assess the feasibility of implementing and measuring outcomes of an adapted Care Ecosystem training model for primary care nurse managers serving a diverse panel of PLWD and their care partners in primary care practices participating in the Mass General Brigham healthcare system's Integrated Care Management Program in Boston, MA. The study team will leverage the Mass General Brigham electronic medical record to determine the feasibility of collecting the primary clinical outcome defined as emergency department visits among the PLWD cared for by the primary care practices. The investigative team will also assess the feasibility of implementation, number of contacts between nurse care managers and care partners, and documented advance care planning.


Eligibility Criteria:
Inclusion Criteria:

* Medicare beneficiary aligned to the Partners Medicare ACO
* ICD-10 diagnosis code consistent with dementia in Medicare claims between August 1, 2019 and July 31, 2020 (excluding diagnoses for diagnostic testing services)
* Actively engaged in care management services with a nurse care manager enrolled in the study

Exclusion Criteria:

- Permanent resident of long-term care or deceased at the start of the study
EXPAREL IPSA Block in Knee Arthroplasty

This is a case series to assess the clinical utility of an Intra-articular Posteromedial Surgeon Administered (IPSA) Block in patients undergoing primary unilateral total knee arthroplasty.

EXPAREL is approved by the Food and Drug Administration (FDA) for use in adults to produce postsurgical regional analgesia via an adductor canal block. The purpose of this study is to evaluate the clinical utility of a surgeon administered EXPAREL adductor canal block intraoperatively in patients undergoing primary unilateral total knee arthroplasty (TKA).

Patients will not be randomized - all patients will receive an EXPAREL IPSA block intraoperatively. Visual Analog Scale, patient reported outcomes, and patient's satisfaction with pain management will be recorded. Adverse events will be monitored.

Eligibility Criteria:
Inclusion Criteria:

1. Indicated to undergo primary unilateral total knee arthroplasty under spinal anesthesia.
2. Primary indication for TKA is degenerative osteoarthritis of the knee.
3. American Society of Anesthesiologists physical status 1, 2, or 3.
4. Able to provide informed consent, adhere to study schedule, and complete all study assessments.
5. Body Mass Index (BMI) \> 18 and \< 40 kg/m2.

Exclusion Criteria:

1. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCL, non-steroidal anti-inflammatory drugs (NSAIDs)).
2. Planned concurrent surgical procedure (e.g., bilateral TKA).
3. Undergoing unicompartmental TKA or revision TKA.
4. Concurrent painful physical condition (e.g. arthritis, fibromyalgia, cancer) that may require analgesic treatment with NSAIDs or opioids in the post dosing period for pain that is not strictly related to the knee surgery and which, in the Investigator's opinion, may confound the post dosing assessments.
5. Previous open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted.
6. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
7. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance.
8. Currently pregnant, nursing, or planning to become pregnant during the study.
9. Clinically significant medical disease that, in the opinion of the Investigator, would make participation in a clinical study inappropriate. This includes diabetic neuropathy, coagulation or bleeding disorders, severe peripheral vascular disease, renal insufficiency, hepatic dysfunction or other conditions that would constitute a contraindication to participation in the study.
10. Chronic opioid use (average ≥30 oral morphine equivalents/day) within 30 days prior to surgery.
Brain Blood Flow Responses During Exercise: Younger Cohort

Brain blood flow will be measured during exercise using magnetic resonance imaging.

Over 6 million Americans are living with Alzheimer's disease and related dementias and this number is expected to reach over 13 million by 2060. Thus, there is an urgent need for interventions to prevent the development and progression of Alzheimer's disease and related dementias. Regular exercise is currently the most promising strategy as it is repeatedly shown to have neuroprotective benefits. Evidence suggests that the neuroprotective effects of exercise is the result of improved health of blood vessels. Despite the vast amount of evidence on the benefit of exercise on the peripheral vasculature, there is little information regarding brain vascular responses during exercise. This study will investigate the impact of exercise at varying intensities on brain blood flow during exercise, and will also examine the influence of age and sex.

This record represents a younger cohort for the study represented in NCT05864950.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men or women between the ages of 20-40 years old
* Demonstrate an exercise history of engaging in aerobic physical activity at least 3 times per week for a minimum of 30 continuous minutes
* Have experience using cardiovascular exercise equipment (e.g., treadmill, elliptical, upright or recumbent bicycle, stair-stepper)

Exclusion Criteria:

* Outside of specified age range
* Do not have experience using cardiovascular exercise equipment
* Do not meet the physical activity criteria
* Present with a history or evidence of hepatic, renal, hematological disease, cardiovascular disease including uncontrolled hypertension, peripheral vascular disease, stroke/neurovascular disease, and diabetes
* have a body mass index ≥35 kg/m2
* are ≥ 71 inches (180 cm) in height
* have any contraindications to MRI
* currently use or have a history of use of tobacco or illegal substances
* have current and/or a history of depression or other mood related disorders (those with mild depression and/or anxiety that is controlled with medication and/or therapy will not be excluded)
* vulnerable populations (e.g., pregnant women, prisoners, individuals lacking capacity to consent)
* if the desired moderate/vigorous exercise intensity corresponds to \> 350 watts on the stepper device
Pharmacodynamics Of Product Octreotide Acetate Lar 30 Mg Compared To Product Sandostatin LAR ®

Check the pharmacodynamics of the drug octreotide acetate LAR 30 mg imported and distributed by Chemical Laboratory Pharmaceutical Bergamo Ltda. compared to the drug Sandostatin LAR ® (octreotide acetate 30 mg) manufactured by Novartis Biociências S / A, using as activity analysis of growth hormone (GH) and growth factor insulin-like 1 (IGF-1 ) after a single dose of the drug in patients with acromegaly

Secondly, it will be observed safety (tolerability) in clinical patients by comparing the clinical and laboratory parameters before and after the study and the incidence of adverse events after a single dose

Eligibility Criteria:
Inclusion Criteria:

- Accept the Terms of Consent;

* be aged over 18, regardless of sex;
* Patients with acromegaly who presented GH levels ≥ 2.5 ng / mL or no suppression of GH levels to less than 1 ng / mL after tolerance test glucose and IGF-I levels for age and sex;
* Patients undergoing hypophysectomy followed by radiotherapy or not and to keep níves increased GH and IGF-I;
* Patients waiting hypophysectomy with increased levels of GH and IGF-I

Exclusion Criteria:

* Have participated in any experimental study or have ingested any drug trial within six months prior to the start of the study;
* Have made use of medications that influence the results, regular 4 weeks prior to the start of the study or having used any medication a week before the start of the study;
* Have been treated with somastostatina analog or dopamine agonist in the last 2 months;
* Present history of myocardial infarction, angina and / or heart failure;
* Patients who present calculation of the gallbladder and have not undergone cholecystectomy;
* Pregnant women and nursing;
* Patients who have allergies to medicine;
* Patients with a history of acute pancreatitis;
* Patient with altered levels of amylase
Laboratory Study Using Samples From Patients With Non-Small Cell Lung Cancer Treated on Clinical Trial CASE-2507

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and RNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at biomarkers in tumor tissue and blood samples from patients with non-small cell lung cancer.

OBJECTIVES:

Primary

* Identify mutations in epidermal growth factor receptor (EGFR) in non-small cell lung cancer specimens from clinical trial CASE-2507.
* Investigate EGFR DNA copy-number changes.
* Determine abnormalities of other pathways, such as the c-MET and PI3K pathways as potential mechanisms of resistance.

OUTLINE: This is a multicenter study.

DNA and RNA are extracted from tumor samples. Genomic DNA is analyzed using real-time PCR/ reverse transcriptase PCR analysis and/or FISH analysis in order to study resistance mechanisms such as secondary EGFR mutations and the c-MET and PI3K pathways. RNA is analyzed using TaqMan quantitative PCR in order to determine the copy number of EGFR expressed in these tissues. Peripheral blood samples are used to isolate peripheral blood mononuclear cells positive for epithelial cell adhesion molecule (EpCAM).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Eligible for and concurrently enrolled on clinical trial CASE-2507

PATIENT CHARACTERISTICS:

* Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
* Normal coagulation profile and platelet count \> 100,000/mm³\*
* Not pregnant NOTE: \*For patients who have not had a second biopsy procedure already at the time of progression on erlotinib hydrochloride therapy and require a research biopsy.

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent anticoagulants (e.g., warfarin or low-molecular weight heparin)
* No concurrent antiplatelet therapy (e.g., aspirin, clopidogrel, or other antiplatelet agents)\* NOTE: \*For patients who have not had a second biopsy procedure already at the time of progression on erlotinib hydrochloride therapy and require a research biopsy.
Patient-Centered Decision Support to Improve Diabetes Management in Pre-Teens and Adolescents With Type 1 Diabetes

Investigators propose to study an intervention that will provide patient-centered, automated decision support to diabetes providers with the goals of improving adherence to medical recommendations (both patients and providers), improving self-management, and ultimately improving health outcomes.

Investigators propose to study an intervention that will provide patient-centered, automated decision support to diabetes providers with the goals of improving adherence to medical recommendations (both patients and providers), improving self-management, and ultimately improving health outcomes. Computer decision support systems (CDSS) have scientifically demonstrated advantages for improving care, and the potential to revolutionize diabetes care because they allow for increased reactive and proactive contact with the health care team, real-time adherence support, and intensification of treatment. In this study,investigators will implement the ADA recommended standards of care using a CDSS developed by the research group - the Child Health Improvement through Computer Automation (CHICA) system.9 One of the greatest strengths of the CHICA system is its ability to implement evidence-based recommendations from authoritative sources, in this case the ADA, in a format that integrates easily into routine care. A second strength of the CHICA system is its ability to screen for patient-centered concerns, including barriers to optimal care such as literacy, socioeconomic issues (i.e., food insecurity, housing insecurity, etc.), and mental health issues (i.e., depression). The provider is alerted, and safety mechanisms are set in motion (i.e., referral to mental health provider, etc.) to address identified issues. In order to ensure that we design the most effective CDSS intervention possible, the study team, in collaboration with the Patient Engagement Core (PEC) of the Indiana Clinical and Translational Science Institute, will partner with adolescents, parents, and other stakeholders in a way that exceeds standard expectations for the engagement of these parties in research. Investigators have experience working directly with patients to elucidate patient-centered outcomes, identify determinants of adherence, and to co-design interventions that are inherently more patient-centered.10-14 By combining a patient-centered design approach along with CDSS investigators will be able to individually tailor recommendations to meet the real needs of patients, taking into account the adolescent patient's perspective and input. This truly innovative approach will offer improved technology-based support systems for diabetes management along with attention to patient-centered goals using co-designed interventions for diabetes self-management.

Eligibility Criteria:
Inclusion Criteria:

1. Adolescents with type 1 diabetes
2. Parents of adolescents with type 1 diabetes
3. Friends/siblings of adolescents with type 1 diabetes
4. Community partners who work with adolescents with type 1 diabetes
5. Diabetes care providers

   -

   Exclusion Criteria:

   -
Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting

The CHOROS pooled analysis is a retrospective secondary data use analysis of integrated individual participant data from a series of planned and on-going primary prospective, non-interventional, multi-center studies sponsored by AstraZeneca and conducted in the pulmonary/primary care practitioner setting in multiple countries and may include data from the following countries: United Kingdom, Germany, Italy, Greece, Japan, Canada and Romania.


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe COPD and initiating BGF treatment according to the local prescribing guidance and as per their treating physician's recommendation
* Enrolled in on-going single-arm studies
* Provided consent for secondary use of data

Exclusion Criteria:

* Did not provide consent for secondary use of data