cyrilzakka/clinical-trials huggingface dataset:
Prevention of Capsular Contracture in Postmastectomy Patients Undergoing Implant-based Reconstructions

The study plans to evaluate capsular contracture at 1-year follow-up in postmastectomy patients receiving immediate implant-based reconstruction and Capsulase® supplementation in the postoperative period. These data are compared with historical data of capsular contracture in patients not receiving any food supplementation postoperatively.

Aim of the study is to collect preliminary data to support Capsulase® supplementation in the postoperative period to prevent capsular contracture.

Capsular contracture is one of the most common complications of breast implant use, in both reconstructive and aesthetic setting. Research on capsular contracture has focused on reducing bacterial contamination of implant surfaces through antibiotic and antiseptic solutions and, more recently, on the pharmacological control of the inflammation process around the implant. The foreign body reaction is responsible for capsular contracture.

Several experimental studies have demonstrated that it is possible to pharmacologically control the inflammation process around implants reducing the profibrotic substances included in the inflammation pathway.

Among diet supplements there are several substances that have been studied for their anti-inflammatory properties, in particular omega-3 fatty acids and boswellic acids.

Capsulase® is a diet supplement and consists of Boswellia serrata phospholipid INDENA®, palmitoylethanolamide (PEA), quercetin phytosome INDENA®, bromelain 2500 Gelatin Dissolving Units/gram (GDU/g) and vitamin E acetate. Its efficacy and safety in women with contracted breast implants have been evaluated both in the reconstructive and aesthetic setting. Although preliminary results are satisfactory, however the series include a small sample of women.

Aim of this study is to collect preliminary data to support Capsulase® supplementation in the postoperative period to prevent capsular contracture, comparing capsular contracture in postmastectomy patients receiving immediate implant-based reconstruction and Capsulase® supplementation in the postoperative period with historical data of capsular contracture in patients not receiving any food supplementation postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Immediate post mastectomy reconstruction with definitive silicone implant (microtextured prosthesis) (both therapeutic and risk reducing mastectomies)
* Informed consent
* Unilateral and bilateral mastectomies

Exclusion Criteria:

* Hypersensitivity to Capsulase®
* Pregnant women
* Impossibility of immediate reconstruction with definitive implants due to inadequacy of mastectomy flaps (inadequate in quantity and/or quality)
* Patients with previous breast implants
* Revisional surgery for capsular contracture
* Use of micro polyurethane foam-coated implants
* Mesh and matrix-assisted reconstructions
* Reconstruction of previous irradiated breasts
Dysphagia Following Anterior Cervical Spine Surgery; Single Dose Steroid vs Saline (DysDexVSSal)

This prospective, randomized, double blind, controlled study evaluates the effect of a single dose of perioperative IV steroid versus saline on swallowing after anterior cervical spine surgery

This investigation is a prospective, randomized, double-blind, controlled trial testing a single dose of peri-operative steroid versus saline and the effect on swallowing after anterior cervical spine surgery.

Swallowing symptoms will be measured using the patient reported Bazaz (Bazaz) scale, the EAT10 survey, and the Dysphagia Short Questionnaire (DSQ). Swallowing data will be obtained pre-operatively, one day and two days post-operatively and then one week, two weeks, four weeks, three months, six months, and one year post-operatively. Patient clinical outcomes will be captured using web-based progress reports. Patients will complete the Quality of Life (QoL-12), Neck Disability Index (NDI), and Visual Analog Scale (VAS) questionnaires electronically pre-operatively and at one year post-operatively. This outcome data will help us analyze the swallowing function or symptoms with the overall clinical course of the patients enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

* Elective anterior approach to subaxial cervical spine (C3 - T1);
* ages 18-80

Exclusion Criteria:

* Traumatic or tumor etiologies
* undergoing anterior-posterior operations
* neoplastic, or infectious conditions requiring surgery
* a history of previous anterior cervical spine surgery
* any patient requiring a halo vest
* patients on chronic steroids
* patients remaining intubated post-operatively (please see more under risks below)
* less than 18 years of age
* pregnant women
* no phone
Weekly Family Food Packages: Food is Medicine

The specific aims and objectives of this proposal are to:

1. Evaluate a food pantry's weekly food distribution impact on behavioral, social and health outcomes in families.
2. In a subset of families with a child aged 6-17 years, test a pilot intervention offering the following components, with a goal of improving family behavioral, social and health outcomes:

   1. Weekly family food packages from the Revere Food Pantry
   2. 6-Monthly group sessions that include information on healthy behaviors, chronic disease management and teaching families how to prepare simple recipes based on the food they receive that week from the food pantry.


Eligibility Criteria:
Inclusion Criteria:

* Referral to the food pantry

Additional inclusion criteria for Group Sessions:

- Family has a child aged 6-17 years

Exclusion Criteria:

- Not able to speak English or Spanish
The Effect of Exercise on Individuals With Parkinson's Disease

The goal of this trial is to compare the effect of two different exercise programs on neuro-physiological, motor, functional, and quality-of-life issues in individuals with Parkinson's disease to determine which program is most beneficial.

Parkinson's disease (PD) negatively affects the quality of life for a million individuals in the United States. While medication and surgery are the most effective treatments for PD, physicians and people with PD often delay using these treatments because of their considerable adverse side effects. Until a cure for PD is discovered, there is a compelling need to develop interventions that provide relief of symptoms without causing negative side effects.

Recent research suggests that exercise may provide symptom relief in some characteristics of PD. While various exercise interventions appear to effectively improve motor, functional, and quality-of-life issues, the research is mixed regarding the nature, extent and duration of these improvements. Understanding how multiple characteristics of PD change and whether they can be modified by different exercise programs is essential to determining if an exercise program is clinically effective for PD.

This study is designed to compare the initial (six months), and then long-term (2 years) effect that 2 different exercise programs (progressive resistance program or flexibility program) have on neuro-physiological, motor, functional, and quality-of-life issues in individuals with Parkinson's disease. The goal is to determine which program is most beneficial. Results from this study will be used to determine which exercise program produces the most beneficial effects on neuro-physiological, motor, functional and quality-of-life measures.

NOTE: Recruitment for Parkinson's disease participants is now closed.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of PD
* Up to the age of 67
* on at least 1 DA drug, may be on several PD medications
* able to walk for six minutes (may take rest breaks)
* able to come off their PD medication for testing (12 hour overnight withdrawal of antiparkinsonian medications)
* able to stay on stable PD medications for at least 6 months
* live within a 30 mile radius of Chicago
* Hoehn and Yahr Score: II - III while in the "Off" PD medication state

Exclusion Criteria:

* history of any other neurological disorder as determined by medical history and neurological exam
* history of a known injury, disease, or other disorder that might interfere with motor function in the proposed experiments
* a score less than 23 on the Mini-Mental State Examination
* currently involved in an active, ongoing formal exercise program deep brain stimulation surgery
* known cardiac problem or significant hypertension
* depression that may interfere with regular exercise
* hallucinations or being treated for hallucinations
Culturally Adapted Strong Families Programme for Families Living in Gilgit Baltistan, Pakistan

The aim of this exploratory study is to test the Strong Family (SF) programme in improving family functioning when implemented in Gilgit-Baltistan. Participants will be randomized to one of the two study arms 1)- Intervention group in which participants will receive 3 group sessions of SF programme (8-12 families per group) 2)- Control group (control group will be in the waiting list and receive SF training sessions once the study will be completed).

This will be multicentre feasibility randomised controlled trial to test the effectiveness of the SF programme in improving family skills outcomes and caregiver and child mental health, as reported by caregivers when implemented in Gilgit-Baltistan. The study will record families' rates of recruitment and attendance to SF programme, evaluate the completeness of programme delivery, cultural acceptability through qualitative interviews and assess the fidelity of training delivery. A small pilot study with N=10 families (a female caregiver (mother) and one child between the age of 8-15 years from each family) will be conducted before main RCT. The study will be conducted in three districts including; Gilgit, Hunza and Skardu in Gilgit Baltistan, Pakistan. We will interview a subset of participants i.e. up to 5 caregivers from each study site (N=15 caregivers) to explore participants' opinions on the acceptability of the programme and to explore any barriers or facilitators to participation.

Eligibility Criteria:
Inclusion Criteria:

* Female primary caregiver to a child aged between 8-15 years
* Able to speak and understand Urdu language
* Capable to give informed consent

Exclusion Criteria:

* Families that had already taken part in another family skills training programme in the past 6 months or where the caregiver lived separately from the child
* Not the primary caregiver of the child
* Unlikely to be available for the duration of the whole study and outcome assessments (e.g., temporary residence).
Effects of Cholecalciferol Supplementation on Bone Health and Muscle Strength in Adults During Post-burn Period

Vitamin D has pleiotropic effects. Burn patients are at risk of hypovitaminosis D and may experience post-injury osteopenia and sarcopenia. Investigators hypothesized that vitamin D supplementation during one year can improve bone and muscle health in post-burn period.


Eligibility Criteria:
Inclusion Criteria:

* occurrence of injury between 2005 and 2011
* burn surface area (BSA) greater than 10%

Exclusion Criteria:

* Pregnancy, renal or liver failure, hypo or hyperparathyroidism, prior vitamin D substitution, treatment using systemic corticosteroids or antiepileptic drugs, regular exposure to ultraviolet B radiation (solarium), unstable cardiovascular disease or acute muscle or skeletal injury prohibiting physical exercise
Evaluation of Image-Based Modelling on Clinical Decisions in Coarctation of the Aorta

To answer the research question: "Would image-based modelling result in different clinical decisions as compared to clinical practice guidelines?", we will conduct a randomized controlled experiment in which we will compare the hypothetical decisions made by interventional cardiologists who are presented with imaging parameters currently recommended by clinical practice guidelines vs. hypothetical decisions made by interventional cardiologists receiving an expanded list of parameters, including simulation modelling.

In collaboration with our three clinical partners, we will first generate two separate imaging datasets for a maximum of three patients recruited to participate in CARDIOPROOF. The first dataset will include the imaging parameters currently recommended by clinical practice guidelines (referred to as "limited dataset"). The second dataset will include an expanded list of parameters, inclusive of information that is available from traditional imaging parameters (as recommended by the guidelines) and simulation modeling (referred to as "image-based modelling dataset").

We will generate both limited and image-based modelling datasets from fully de-identified patients already enrolled in CARDIOPROOF (NCT02591940) who have consented to publication of data in anonymized form.

Using a computerized random-sample function, we will randomly allocate interventional cardiologists into two separate groups and present them with one set of imaging data. The first group will receive a "limited" dataset including only information that is available from traditional diagnostics (as recommended by the clinical practice guidelines) for a pre-specified number of patients (maximum of 3). The second group will receive the full, detailed dataset inclusive of information that is available from traditional diagnostics (as recommended by the guidelines) and simulation modelling for the same set of patients.

We will then ask the interventional cardiologists in the two groups to make (hypothetical) clinical decisions using the dataset of imaging parameters presented to them. The clinical decisions will be hypothetical because patients will have been treated according to clinical practice guidelines and this experiment will retrospectively involve interventional cardiologists who are not directly involved in the care of the patients participating in CARDIOPROOF.

The analysis will focus on each hypothetical scenario and compare the proportions of cardiologists making different types of intervention decisions in the two randomly allocated groups.

Eligibility Criteria:
Inclusion Criteria:

* Practicing interventional cardiologists
* Has treated patients with coarctation of the aorta during the past 6 months

Exclusion Criteria:

* Participation in CARDIOPROOF trial
A Multiple Dose Study of MK-3614 (MK-3614-002)

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of MK-3614 in male participants with mild to moderate hypertension. The primary hypotheses are: 1) Multiple oral doses of MK-3614 are sufficiently safe and well tolerated to permit continued clinical investigation 2) Aortic Augmentation Index (Aix) is reduced 24 hours post the last dose of MK-3614 administered compared to placebo and 3) Increase in the 12-hour weighted averages (TWA 0-12hours) of the heart rate is within 15 beats per minute (bpm) of baseline on first day of multiple dosing of MK-3614 and within 10 bpm of baseline on last day of multiple dosing of MK-3614.


Eligibility Criteria:
Inclusion Criteria:

* Has mild to moderate hypertension
* Has grade 1 or 2 arterial hypertension being treated with a single antihypertensive drug
* Has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months; or who have discontinued smoking or the use of nicotine/nicotine-containing products for at least approximately 3 months
* Is in generally good health

Exclusion Criteria:

* Has a history of clinically significant abnormalities or diseases
* Has a history of stroke, chronic seizures, or major neurological disorder
* Has a functional disability that can interfere with rising from a sitting position to the standing position
* Has any personal or family history of a bleeding or a clotting disorder
* Has a history of frequent nose bleeds or has recurrent or active gingivitis
* Has a history of cancer
* Has a history of clinically significant cardiac disease
* Is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies approximately 2 weeks prior to the administration of study drug
* Consumes excessive amounts of alcohol
* Consumes excessive amounts of caffeinated beverages per day
* Has had major surgery, donated or lost 1 unit of blood or participated in another investigational study within 4 weeks of study
* Has a history of significant multiple and/or severe allergies (including latex) to prescription or non-prescription drugs or food
* Is currently a regular user of any illicit drugs or has a history of drug abuse within approximately 1 year
An Observational Study of Patients With Lysosomal Acid Lipase Deficiency/Cholesteryl Ester Storage Disease Phenotype

This is a Natural History study to characterize key aspects of the clinical course of late onset Lysosomal Acid Lipase (LAL) Deficiency/ Cholesteryl Ester Storage Disease (CESD).

The objective of this study is to characterize key aspects of the clinical presentation, disease phenotype and progression of patients with late onset Lysosomal Acid Lipase (LAL) Deficiency/ Cholesteryl Ester Storage Disease (CESD) including, but not limited to, age of presentation, onset of hepatomegaly, progression over time of liver function, and stability of lipid abnormalities.

Eligibility Criteria:
Inclusion Criteria:

* Patients with late onset LAL Deficiency/ Cholesteryl Ester Storage Disease (CESD) who are 5 years of age or older and have required data points in their medical record

Exclusion Criteria:

* Required data points for inclusion are not available
Atelectasis After Pulmonary Lobectomy: The Effect Of Air During One-Lung Ventilation (OLV) On Postoperative Atelectasis

Patients scheduled for lung lobe resection using video assisted thoracic surgery will be randomly assigned to be ventilated with either only oxygen or a mixture of air and oxygen.

The primary purpose of this study is to determine if the incidence of postoperative collapse (in the non-surgical lung) is decreased when using a mixture of air and oxygen compared to using only oxygen (which is our control measurement) during one-lung ventilation.

One of the concerns with all thoracic procedures employing One Lung Ventilation (OLV) is intra-operative hypoxia due to the large shunt that develops when only one lung is being ventilated. Ventilation with a higher fraction of inspired oxygen (FIO2) is one of the commonly chosen strategies for the treatment of hypoxemia during (OLV) for thoracic surgery. Using an FIO2 of 1.0 at all times during (OLV), however, may increase the risk of absorption atelectasis intra and postoperatively which itself leads to persistent hypoxia and potentially pneumonia.

The aim of this study is therefore to determine the impact of adding air to the inspired fraction of oxygen during (OLV) primarily on the incidence of postoperative atelectasis of the nonsurgical lung after lung resection using video assisted thoracic surgery and secondarily on intraoperative and postoperative oxygenation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Competent to give consent to enroll in study
* Booked for open thoracotomy procedure for lobectomy
* American Society of Anesthesiologists comorbidity score 1-4

Exclusion Criteria:

* Unable or unwilling to give consent
* Pregnant women
* Inability to insert an arterial line
* Severe COPD (FEV1 \< .7% predicted, or FEV1/FVC \< 0.70)
* Presence of other significant pulmonary impairment (PaO2 on room air 50 mmHg, PaCO2 \> 50 mmHg or known pulmonary HTN mean PAP \> 25 mmHg)
* Presence of significant cardiovascular disease (+MIBI that is non-revascularized, CCS ≥ 3 angina, NYHA ≥ 3 CHF, EF (by angiography or echocardiogram \< 40%)
* Chronic renal failure (serum Cr \> 200)
* Altered liver function
Healthy Activities Improve Lives

The investigators have developed an online platform to support the 8-week, F\&S! exercise program called the Healthy Activity Improves Lives (HAIL) online platform. The aims of this study are to conduct an open pilot trial with exit interviews (N=30) of the HAIL online platform in two racially diverse churches to evaluate its feasibility and acceptability (Hypothesis 1) as well as explore its efficacy (Hypothesis 2).

This is an open pilot study to evaluate the feasibility and accessibility of the HAIL online platform. This study will enroll two cohorts (i.e., at two racially diverse churches) for a total number of 30 participants. This study will use a phone screen to assess participants' eligibility and explain the study procedures. Eligible individuals will then be given a link to complete an e-Consent in REDCap as well as instructions on how to access the HAIL online platform to complete assessments as part of the baseline visit. Participants will complete the 8-week F\&S! exercise program (with access to the adjunct HAIL online platform), which will be delivered in-person as well as remote, and then continue to use the HAIL online platform during the 3-mo follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Individuals over the age of 60 years
* Participants are able to travel to one of the churches for the in-person F\&S! exercise sessions
* Participants cannot be currently participating in a regular PA (physical activity) program (i.e., at least 100 min per week of moderate to vigorous physical activities)

Exclusion Criteria:

* Participants do not understand study procedures or are unable to participate in the verbal consent process
* Participants must have a physician responsible for their medical care
* Participants endorse an item on the Revised Physical Activity Readiness Questionnaire (rPAR-Q) as confirmed by their treating physician
* Participants who report any contraindication to exercising (e.g., recent ECG changes or myocardial infarction, unstable angina, uncontrolled arrhythmias, third degree heart block, congestive heart failure)