cyrilzakka/clinical-trials huggingface dataset:
Image - Navigated Resection of Lung Nodules

This is an open label study lung nodules that are either cancer or non-cancer and who are eligible for surgical resection. Patients will undergo their surgery with the help of the Lung Resection Marker Locator Kit which will assist the surgeon in both the location and resection of the lung nodule under real-time guidance.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged 21 years or older as it is extremely rare for younger people to be at risk for lung cancers.
2. Be deemed candidates for the lung resection surgery, which will be determined by their treating Thoracic Surgeon (also a physician investigator)
3. Have lesions that are nodules/GGO or other abnormal opacity that can be accurately measured in at least one dimension using conventional techniques
4. Seen at BWH Thoracic Surgery outpatient clinics or as inpatient (Note: Subjects will be formally consented to the study at BWH only)

Exclusion Criteria:

1. Female subjects pregnant or breastfeeding
2. Subjects with a pacemaker or equivalent devices (AICD) due to the use of electromagnetic tracking generator.
3. Patients who are not scheduled for lung surgery

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Codeine in Mechanically Ventilated Neonates

The purpose of this study is to determine the absorption and bioavailability of codeine in relation to postnatal (PNA) and postconceptional (PCA) age; determine the parent drug (codeine), its active metabolites, their formation rates and their ratios in relation with PCA and PNA; and identify relevant genetic polymorphisms of opioid metabolism in the study population and their potential relationship to the biodisposition and pharmacodynamic effects of codeine. The study population is intubated and mechanically ventilated infants equal to or greater than 26 weeks gestational age at birth and less than 4 weeks postnatal age.

This proposal has its origins in a larger initiative to elucidate the pharmacological basis for the interindividual differences observed in opioid responsiveness. Gaps in our knowledge related to opioid disposition in newborns need to be addressed to complete the design of the required overarching initiative in which age could be treated as a continuous variable within a context of PK, PD and PG determinants.This proposal is designed to generate preliminary data that addresses two issues. First, can newborns absorb enterally administered codeine and is this ability determined by PCA or PNA age? The second relates to the ability of newborn infants to catalyze those reactions required to metabolically activate both codeine and morphine. The latter will also be evaluated within the context of PCA versus PNA age.

These data will not only fill an information gap that must be addressed before the larger initiative moves forward, but they also provide a platform for serious study of the ontogeny of certain pharmacokinetic processes that may prove critical to our understanding of newborn drug disposition. In this way, codeine can provide important insights concerning the ontogeny of drug disposition and permit the determination of the relative importance of PCA versus PNA ages to the functional expression of these processes.

Eligibility Criteria:
Inclusion Criteria:

* Neonates ≥ 26 weeks PCA receiving mechanical ventilation and painful procedure will be eligible for participation in the study
* Subject's parent/legal guardian must give written informed consent prior to study participation
* Subject is receiving opioid analgesia therapy based on caregiver determination. The ideal patient will not be receiving morphine.
* Must be able to receive an enteral dose of codeine.

Exclusion Criteria:

* Known hypersensitivity to morphine, fentanyl, or codeine
* Patients with ALT concentrations \>2x upper limit of normal for age or clinical evidence of hepatic failure
* Patients with serum creatinine concentrations \>2x upper limit of normal for age or clinical evidence of renal failure
* Patients who are NPO
* Babies born to maternal drug abuse.
* Total serum bilirubin level of \> 10 mg/dl or 170 umol/L.
Analysis in the EMERGEncy Between TransVenous Cardiac PACIng Guided by Fluoroscopy Versus Echocardiogram

A lot of questions about use of temporary transvenous pacing still remain obscure and there is no effective comparison between use of fluoroscopy versus electrocardiogram/echocardiogram in patients with bradicardias. The aim of the study is to evaluate how long does it take to start the correct cardiac stimulation with transvenous pacing in patients with bradicardias comparing use of fluoroscopy versus electrocardiogram/echocardiogram and compare rates of complications between two methods.

Approximately 150 subjects will be recruited over a planned recruitment period of 18 months. Patients will be submitted to ecchocardiogram using Philips Envisor, and electrocardiogram with Philips Healthcare PageWriter TC30.

Eligibility Criteria:
Inclusion Criteria:

* adult males and females aged \> 18 years
* symptomatic bradicardia
* informed consent signed.

Exclusion Criteria:

* pregnancy
* hemodynamic instability (pulmonary congestion / systolic arterial pressure lower than 90 mmHg)
* body mass index greater than 40 kg/ m2
* use of oral anticoagulation
* acute coronary syndromes
* left ventricle ejection fraction \< 45%
* presence of any kind of cardiac stimulation device
Exploring the Effects of Antihypertensive and Lipid-Lowering Drugs on Inflammatory Cytokine Levels

This study investigates the causal relationships between antihypertensive and lipid-lowering drugs and inflammatory cytokines using a drug-targeted Mendelian randomization approach. By leveraging genome-wide association studies (GWAS) and expression quantitative trait loci (eQTL) data, the study evaluates the effects of angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), HMG-CoA reductase inhibitors, PCSK9 inhibitors, and NPC1L1 inhibitors on key inflammatory cytokines such as IL-1β, TNF-α, CRP, and MCP-1. The findings aim to provide insights into the prevention and control of excessive inflammatory responses, particularly in patients with hypertension and dyslipidemia, by assessing the causal effects of these therapies.

This observational study focuses on elucidating the causal relationships between commonly prescribed antihypertensive drugs (ACEIs and ARBs) and lipid-lowering drugs (HMG-CoA reductase inhibitors, PCSK9 inhibitors, and NPC1L1 inhibitors) with various inflammatory cytokines, including IL-1β, TNF-α, CRP, MCP-1, and IFN-γ, using a drug-targeted Mendelian randomization (MR) framework. The study employs large-scale genetic data from European populations, drawing from genome-wide association studies (GWAS) and expression quantitative trait loci (eQTL) datasets, to construct instrumental variables that mimic the effects of drug exposure.

The primary aim is to explore how these pharmaceutical interventions influence inflammatory pathways at the molecular level. The use of MR methods enables causal inference by utilizing genetic variants within or near drug-target genes, allowing for the estimation of downstream effects similar to those produced by actual drug interventions. Key statistical methods, including inverse variance weighting and sensitivity analyses, are applied to ensure robustness and validity of the results.

This research provides critical evidence for the selection of antihypertensive and lipid-lowering therapies that not only manage cardiovascular risk factors but also modulate inflammation, contributing to personalized medicine strategies for patients with chronic inflammatory conditions. Furthermore, the findings have broader implications for drug repurposing and the development of new therapeutic targets aimed at mitigating inflammatory processes that underlie various chronic diseases.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18 years or older.
* Diagnosed with hypertension, coronary artery disease, or dyslipidemia.
* Availability of complete genome-wide data and inflammatory cytokine levels.
* Willingness to participate in the study and provide the required clinical data.

Exclusion Criteria:

* Participants under the age of 18.
* Individuals with severe chronic diseases or other conditions that may significantly influence inflammatory responses.
* Individuals unwilling or unable to provide necessary clinical or genomic data.
* Pregnant or breastfeeding women.
Masseter Muscle Thickness and Craniofacial Skeletal Patterns

Facial morphology is influenced by hard and soft tissues, including bone and muscle. While numerous factors can lead to changes in bone tissue, soft tissues such as muscle also have an important influence. It is widely acknowledged that the function, shape and thickness of masticatory muscles have substantial effects on facial morphology and skeletal development, and are correlate with other anthropometric variables. Furthermore, a correlation has been observed between masseter muscle thickness and various characteristics of the dental arches, such as alveolar process thickness and intermaxillary width.

The evaluation of soft tissue in the region of the face is a more challenging process in comparison to that of hard tissue.The recent development of cone beam computed tomography has improved the analysis of three-dimensional skeletal morphology and jaw. However, the radiographic assessment of soft tissue remains more difficult.The thickness of masticatory muscles can be measured using computerised tomography; however, this has the disadvantage of exposing the patient to radiation. Magnetic resonance imaging (MRI) is an imaging technique that can be used to assess soft tissues. However, this technique is expensive and time-consuming. Furthermore, MRI is a static rather than a dynamic imaging technique, which makes it difficult to analyse during muscle contraction and relaxation. Ultrasound is a technique that provides dynamic imaging that can assess the masticatory muscles without the use of ionising radiation.

There are many publications in the literature that indicate that malocclusions in the vertical and sagittal dimensions can be assessed with measurements from lateral cephalometric radiographs.


Eligibility Criteria:
Inclusion Criteria: Patients who

* Patients who were 18 years of age or older,
* had skeletal malocclusion,
* were systemically healthy,
* were not taking any medication,
* had no missing teeth except for the third molars,
* had no history of congenital and/or acquired anomalies in the lips, mouth and facial regions,
* had not received orthodontic treatment before

Exclusion Criteria: Patients who

* were younger than 18 years of age
* were with systemic disease,
* used antidepressant drugs before,
* has bruxism habit,
* had orthodontic treatment or has active orthodontic treatment,
* had history of trauma and surgery in the maxillofacial region
Standardised Regional Sport-club Based Exercise Programmes

Background: More than 10% of the adult population in Styria, a federal state in the south of Austria, is allotted to a stationary stay at a health resort each year. In practice approximately 50.000 adults receive these stays that are financed from the health insurance companies and that last up to 3 weeks. The target group for theses stays is the general population aged between 30 and 65 years that shows minor health deficits like back pain or risk factors for cardio-metabolic diseases. The treatment during the stays consists of exercise, nutritional and psychological interventions. Thus the increase of physical activity is an important goal that is focussed during the stationary stay. Because of the absence of regional facilities that are linked to the resorts and that provide accesses to standardised regional programmes sustainability is questionable.

Methods/Design: This prospective controlled open label study compares two study groups. After a stationary stay at a health resort patient are allocated to a standardised, regional sports-club based exercise programme or to another group, where only written hand-outs are provided. The primary outcome is the weekly level of health enhancing physical activity which is objectively measured with an accelerometer and an activity log-book. Additionally, social determinants are requested, fitness and anthropometric measurements are done at baseline until 12 months. Beside the changes in measurable parameters, processes are evaluated accurately. Consequently the gateway - function of the health resort is analysed.

Discussion: The structured cooperation between the health sector, where health resorts informing and assigning patients to regional sports-clubs and the sports sector potentially provides a wide network of standardised programmes. Within this study we aim to evaluate the sustainability of stationary stays and a continuing regional standardised exercise programme.


Eligibility Criteria:
Inclusion Criteria:

* Austrian physical activity recommendations for substantial health benefits are not reached. (Weekly \< 150 Minutes of aerobic moderate intense physical activity, or \< 75 minutes of aerobic vigorous intense physical activity or an equal combination as well as and/or muscle-strengthening activities at least twice a week are not realised.)
* Stationary stay at a health resort
* Physical activity in the patient's responsibility is recommended
* Systolic blood pressure at rest ≤ 90 mm/Hg
* Diastolic blood pressure at rest ≤ 140 mm/Hg

Exclusion Criteria:

* More than 10% planned or unplanned weight loss / weight gain during the last 6 months
* Pregnancy
* Indication for stationary or outpatient rehabilitation based on the
* Untreated coronary heart disease
* Untreated micro- or macrovascular artery disease
Oral Green Tea Extract for Small Cell Lung Cancer

The purpose of this study is to determine whether green tea extract is safe for extensive-stage small lung cancer who achieved objective tumor response after first-line therapy.

Small-cell lung cancer accounts for 13 to 15% of all lung cancer and more than 60 to 70% of patients present with extensive disease (ED). Although etoposide plus cisplatin (EP) regimen has been the mainstay of ED-SCLC treatment, median overall survival is about 9 months, with 5 to 10% surviving two years and only 1% of patients achieving a long-term disease-free survival. To improve this outcome further, various attempts have been made, which included dose intensification with stem cell supports, maintenance therapy, and also searches for a better chemotherapy regimen.

Significant anticarcinogenic effects of green tea extract on various organs, such as skin, stomach, duodenum, colon, liver, pancreas, and lung in rodent models have been confirmed. Recent scientific investigations have identified the active chemical compounds in green tea designated tea polyphenols or catechins. Epigallocatechin-3-gallate (EGCG) is the major catechin in tea.An investigation about the effects of EGCG on human SCLC cells revealed that EGCG had similar anti-tumor effects on drug-sensitive (H69) and drug-resistant (H69VP) SCLC cells. Thus, the investigators conduct this phase I trial, the objectives of this trial were to study the side effects and best dose of of EGCG in treating patients with small-cell lung cancer who achieved objective tumor response after first-line therapy.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of small cell lung cancer
* extensive-stage disease
* Eastern Cooperative Oncology Group performance status (PS) of 0 to 2
* age18 years old
* Adequate bone marrow reserves: neutrophil (ANC) count ≥ 1500 /mm\^3, platelet count ≥ 100,000 /mm\^3, hemoglobin ≥ 9 g/dl
* Adequate renal function: serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 60 ml/min
* Adequate hepatic function: bilirubin level ≤ 1.5 x ULN, ASAT \& ALST ≤ 1.5 x ULN
* Signed written informed consent prior to study entry
* According to Response Evaluation Criteria in Solid Tumors(RECIST), patients didn't progress after first-line chemotherapy

Exclusion Criteria:

* Any condition that would hamper informed consent or ability to comply with the study protocol
* Participation in another research study in the last three months
* Known malignancy at any site other than SCLC
* Recent consumption of green tea (5 or more cups per day within one week of study enrollment)
* Pregnant and lactating women
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to EGCG
Treatment of Non-Hodgkin's Lymphoma With 90Y-hLL2 IgG

The purpose of this trial is to determine the safety of a 90Y-radiolabeled, humanized (CDR-grafted) form of the LL2 monoclonal antibody in patients with Non-Hodgkin's lymphoma (NHL) at different dose levels.


Eligibility Criteria:
Inclusion:

* Histological or cytological diagnosis of B-cell lymphoma, and has failed at least one regimen of standard chemotherapy. (All histological grades of NHL will be eligible for this trial.)
* Measureable via CT, with at least one lesion \> or = 1.5cm in one or both dimensions. (Splenic tumors in absence of other tumors will not qualify.)
* Radiological studies (ie - CT) must be performed within 4 weeks prior to study start.
* Acceptable tumor burden that will allow adequate follow-up and evaluation.
* Less that 25% bone marrow involvement, determined by bone marrow biopsy.
* Must observe the following washout periods:

At least 4 weeks beyond any major surgery. At least 4 weeks beyond any radiation therapy to the index lesion, and has recovered from radiation-induced toxicity.

At least 4 weeks beyond chemotherapy and/or immunotherapy. At least 2 weeks beyond corticosteriod(s) use and blood counts are with laboratory criteria.

* Must have Karnofsky score \>70% (or equivalent, ECOG 0-2) with expected survival of at least 6 months.
* Serum creatinine \< or = 1.5mg/dl or creatinine clearance \> or = 50ml/min.
* Serum bilirubin \< or = 2mg/dl.
* Hemoglobin \> or = 10 g/dl; WBC \> or = 3000/mm3; granulocyte count \> or = 150/mm3; platelet count \> or = 100,000/mm3 with out transfusions or cytokines for at least 30 days prior to study.
* Immunomedics ELISA assay of HahLL2 \< 100ng/ml for those with prior history of monoclonal antibody infusions.
* Cognizant informed consent.
Percutaneous Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy in Children

The primary purpose of this study was to demonstrate the safety and efficacy of percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) in children and assessed its performance and functional outcomes in the follow-up. This is an observational, single-arm, single-center study.

The prevalence of hypertrophic cardiomyopathy (HCM) ranks second among cardiomyopathies in children. The prognosis of HCM has been previously demonstrated to be closely correlated with age. HCM in childhood is frequently associated with severe symptoms and high mortality rates, exhibiting a 36% higher incidence of malignant ventricular arrhythmias compared to adults, and being twice as likely to necessitate advanced heart failure therapies such as heart transplantation or left heart assist devices. Surgical septal myectomy can effectively help patients with drug-refractory symptoms but carries risks inherent to invasive procedures and requires expertise that is not universally available. Alcohol septal ablation is not recommended for applications in the young patient group.

Percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) is a new method for the treatment of HCM using a special diagnosis and treatment device on the target area of the heart under the guidance of echocardiography. The method breaks through the worldwide problem of minimally invasive treatment of the myocardium on the beating heart, thus avoiding X-ray radiation and contrast agent damage. Previous research has illustrated the effectiveness and safety of PIMSRA for adult patients with obstructive HCM. We have found that PIMSRA results in sustained improvement in exercise capacity, persistent reduction in left ventricle outflow tract (LVOT) gradient, and sustained improvement in cardiac function.

This is an early feasibility study to evaluate the clinical safety and efficacy of PIMSRA in pediatric patients, as well as to assess postoperative cardiac function and exercise capacity.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hypertrophic obstructive cardiomyopathy
* Age younger than 18 years
* Resting or provoking left ventricular outflow tract gradient ≥ 50 mmHg
* Drug-refractory symptoms or intolerable to pharmaceutical therapies
* Heart function of New York Heart Association ≥ class II

Exclusion Criteria:

* Secondary left ventricular hypertrophy (LVH) related to subaortic stenosis or aortic stenosis
* Presence of concomitant heart disease requiring surgery
* Left ventricular ejection fraction \<40%
* Cardiac resynchronization therapy within 3 months
The COMPASSION Study

The aim of this research study is to better understand the in-home hospice experience for participants, caregivers, hospice nurses, and oncology providers by conducting telehealth check-ins between participants and caregivers and oncology care teams.

The aim of this research study is to better understand the in-home hospice experience for participants, caregivers, hospice nurses, and oncology providers by conducting telehealth check-ins between participants and caregivers and oncology care teams.

Study procedures include giving verbal consent to participate and a one-time survey delivered by email or phone call.

About 200 people, which includes 50 participants, 50 caregivers, 50 hospice nurses, and about 50 oncology providers, are expected to participate in this research study.

Eligibility Criteria:
Inclusion Criteria:

* Patient of any gender with unresectable locally advanced or metastatic breast cancer
* Eligible for in-home hospice services and referred by DFCI clinical team to in-home hospice \</= 1 week before enrollment
* Ability to conduct video or phone check-ins, even if assistance required.
* Able to provide verbal consent with a willingness to take a survey at 4-6 weeks, if medically able
* Hospice setting is within Massachusetts
* Non-English language allowed but interpreter services must be present at each meeting and will be coordinated by scheduling team
* Willingness to provide a caregiver/loved one's contact information for survey contact at 4 weeks after enrollment

Exclusion Criteria:

* Unable to provide verbal consent
* Hospice care planned outside of a home setting (note: if participants start out in a home hospice setting but later transition their hospice care to an inpatient setting, enrollment is allowed as long as they started in a home setting)
* Hospice setting outside of Massachusetts
* Individuals who are under the age of 18, as this is not a project focused on pediatric patients.
POMCO2 Clinical Study MicroTrend System pCO2 Sensor

The objective of this non-significant risk (NSR) study is to evaluate the safety and efficacy of the MicroTrend System by correlating POMCO2 data with relevant clinical metrics including arterial pressure and heart rate.

This is a prospective, single-center, non-randomized, non-significant risk (NSR) study evaluating the safety and efficacy of the MicroTrend System, which is indicated for monitoring oral mucosal carbon dioxide pressure (POMCO2) in hospital patients.

Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized adult (age 22 years and older) in the critical care unit
2. Willing and able to provide independent written informed consent (or the patient's legal representative, if applicable)
3. Willing and physically able to comply with the study protocol and procedures

Exclusion Criteria:

1. Evidence of intra- or peri-oral, buccal, or gingival disease or trauma to the face or mouth that may interfere with MicroTrend System that is deemed clinically significant by the investigator
2. Any clinically significant medical health history or vital sign deemed by the investigator to potentially interfere with study conduct
3. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)