cyrilzakka/clinical-trials huggingface dataset:
Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study

The investigators hypothesize that Obstructive Sleep Apnea (OSA) is an independent risk factor for atrial fibrosis development. The investigators aim to prove the presence of atrial fibrosis on Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) in OSA patients without atrial fibrillation (AF).

This is a cross sectional pilot study. Sixty mild to severe OSA patients and five age- and Body Mass Index (BMI)-matched controls will undergo a DE-MRI. Demographics, medical history and polysomnography results will be collected. Patients diagnosed with obstructive sleep apnea have undergone a polysomnography before the study and were diagnosed based on this test. The investigators will not be performing a polysomnography for any of the patients, just collecting the previous results from their medical charts to confirm they have a true OSA diagnosis for their inclusion in the study.

Eligibility Criteria:
Inclusion Criteria:

Group A: 10 patients 18-75-year-old With mild OSA (5\<AHI\<15), confirmed by polysomnography. No previous AF diagnosis on the medical chart

Group B: 10 patients 18-75-year-old With moderate OSA (15\<AHI\<30), confirmed by polysomnography. No previous AF diagnosis on the medical chart

Group C: 10 patients 18-75-year-old With severe OSA (AHI\>30), confirmed by polysomnography. No previous AF diagnosis on the medical chart

Group D (mild OSA+ AF): 10 patients 18-75-year-old With mild OSA (5\<AHI\<15), confirmed by polysomnography. Previous AF diagnosis

* In this group, patients with AF and OSA who already have done MRI might be included.

Group E (severe OSA +AF): 10 patients 18-75-year-old With severe OSA (AHI\>30), confirmed by polysomnography. Previous AF diagnosis

\*In this group, patients with AF and OSA who already have done MRI might be included.

Group F (Control): 10 Patients 18-75-year-old No previous OSA and/or AF Diagnosis on the medical chart

Exclusion Criteria:

* History of chronic heart failure (LVEF \< 50%), AF, myocardial infarction, valvular disease.
* Prior cardiac or chest surgery.
* Other advanced pulmonary disease (severe Chronic Obstructive Pulmonary Disease (COPD) or asthma, pulmonary hypertension) or central sleep apnea.
* Contraindications to DE-MRI (e.g. allergy to gadolinium, pacemakers, defibrillators (ICD's), other devices/implants contraindicated for MRI, glomerular filtration rate \<30 ml/min, etc.).
* Pregnancy.
* Inability to give informed consent.
Treatment Effect of Intense Pulsed Light and Thermal Pulsation Therapy on Meibomian Gland Dysfunction-associated Dry Eye Disease: a Randomized Trial

The goal of this clinical trial is to understand novel treatment methods for meibomian gland dysfunction (MGD)-associated dry eye disease (DED) by comparing two treatment modalities- intense pulsed light (IPL) and thermal pulsation therapy (TPT), to find out the difference of their therapeutic mechanisms and treatment effects, so that eye doctors can give more precise advice to the patients when making treatment decisions.

The main questions it aims to answer are:

* What subtype of meibomian gland dysfunction (MGD) better responds to which treatment modality?
* How long do the treatment effects last?

Researchers will compare each group (IPL and TPT) to a control group treated with eyedrops.

\* Do combined treatment of IPL or TPT with eyedrops show better outcomes than only eyedrops?

Participants will:

* Receive different treatment for 2 months according to the group they were randomly allocated to.
* Visit the clinic for checkups after 1 and 3 months after completing the treatment sessions.


Eligibility Criteria:
Inclusion Criteria:

* individuals diagnosed with meibomian gland dysfunction (MDG)-associated dry eye disease (DED) that are suitable for intense pulsed light (IPL) and thermal pulsation therapy (TPT)

Exclusion Criteria:

* ocular surgery or trauma in the recent 3 months
* ocular infection
* eyelid abnormalities (e.g., entropion, ectropion, lagophthalmos, severe ptosis or trichiasis)
* blepharospasm
* eyelid tumor
* severe meibomian gland atrophy
* allergic to topical anesthetics
* sunbathe in recent one month
* periocular fillers
Impact of Component Design and Fixation in Total Knee Arthroplasty

The purpose of this study is to determine implant design and determine if method of fixation cemented versus cementless results in different bone loss patterns. The investigators also want to determine if clinical outcomes correlate with bone density changes.

Patients who present to the clinical practices of Dr. Ryan Nunley and Dr. Robert Barrack and are suitable candidates for primary total knee arthroplasty(TKA) type assigned either cemented or cementless and Triathlon knee or Depuy by surgeon will be screened for eligibility and invited to participate. Data collected for the study will include standard of care clinical and radiographic evaluations collected during office visits and surgery, Dual Energy X-Ray Absorptiometry(DEXA) Bone density monitoring, as well as study-specific patient questionnaires. Clinical, radiographic and questionnaire data will be collected pre-operatively, at the time of surgery, and at 6 weeks, 1 year and beyond, and 2 years and beyond post-operatively. Patients will complete the following outcomes questionnaires preoperatively: New Knee Society Score, Oxford Knee Score, UCLA Activity Score, SF-12, and EQ-5D. The following questionnaires will be collected at four to six weeks, six months, one year and beyond, and two years and beyond postoperatively: New Knee Society Score, Forgotten Joint Score, Washington University Knee Satisfaction and Function Questionnaire, Oxford Knee Score, UCLA Activity Score, SF-12, and EQ-5D, and a Pain Drawing.

Eligibility Criteria:
Inclusion Criteria:

* Patients who qualify for a Primary Total knee using Triathlon Implant(thin tray) or Depuy Attune(thick tray) Implant
* 18-75 years of age
* Willing to sign informed consent
* Willing to return for all follow-up visits

Exclusion Criteria:

* Patients with inflammatory arthritis
* BMI \> 40
* Patient with an active infection or suspected infection in the joint
* Patient who have undergone osteotomy
* Patients who have a previous diagnosis of osteopenia/osteoporosis or patients with weak bones and/or currently on medications to increase bone density/who have poor bone quality
* Patients who have had previous patella fracture or surgery
* Patients who have had previous knee or hip replacement surgery on the ipsilateral side
* Patients who require patellar resurfacing
* Patient with major medical/muscular/orthopedic deformities
* Unable to undergo DEXA scanning.
* Female patients of childbearing potential and an interest in getting pregnant in the future \*NOTE: Patients receiving simultaneous bilateral total knee arthroplasties are eligible. Both knees are eligible for enrollment as long as all other inclusion/exclusion criteria are met for each knee. If only one knee is eligible it will be included. Patients receiving staged bilaterals are also eligible, provided that each knee meets the inclusion exclusion criteria.
SWORD Health Patient Registry

The purpose of this study is to create a research repository, comprised of data collected in the course of physical rehabilitation programs for musculoskeletal disorders (MSDs) using the medical device SWORD Phoenix®.

This will allow the company to ascertain the acceptance, engagement and effectiveness of programs using this asynchronous tele-rehabilitation platform in the treatment of multiple MSDs.

The data that will be collected in the scope of this registry includes:

1. data that is sourced from the subject, which will be collected by the physical therapist managing that subject;
2. data that is generated by the physical therapist through interaction with the web-based Portal (i.e. session composition in terms of exercises, sets, repetitions, usage or not of external resistance)
3. data that is generated by the subject through interaction with the app (i.e. pain and fatigue levels, satisfaction)
4. data that is generated automatically by the medical device (i.e. range of motion, compliance)

Collection and objective analysis of the collected data will allow:

1. Assess the adoption, engagement and feasibility of digital care programs for musculoskeletal conditions and musculoskeletal health
2. Assess the results of digital care programs and compare the costs with the benefits obtained;
3. Correlate the results with patient's demographic and clinical profiles;
4. Examine the impact of mental health and the behavioral modification components of SWORD Health interventions on disease markers, comorbidities, and productivity;
5. Increase the knowledge on several musculoskeletal conditions, namely how they progress and respond to digital care programs;
6. Develop new or improved tools to assist clinicians in the management of these conditions and in helping people achieve better musculoskeletal health

Clinical outcomes

The primary outcome will be the evolution of patient's clinical condition along the rehabilitation program, objectively estimated through the monitoring data collected using SWORD Phoenix®, as part of patients' supervision routine. Depending on the condition, primary and secondary outcome measures vary.

In any case, this registry will include a complete characterisation of the clinical condition, as well as the periodic assessment of: a) joints' range of motion (collect by the medical device); b) performance indicators (through condition-specific tests); c) patient-reported outcomes (obtained using internationally validated pathology-specific questionnaires); d) pain and fatigue levels (reported by patients by the end of each therapeutic exercise session); e) compliance; f) patient satisfaction

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old;
* Initiating a rehabilitation program using the medical device SWORD Phoenix®;
* Able to understand study procedures and willing to provide informed consent.

Exclusion Criteria:

* None
Comparison Between 2 Protocols for the Treatment of Class II Division 2 Malocclusion

The aim of this prospective study was to compare between two different treatment modalities of class II division 2; to start treatment in upper arch first until adequate overjet is obtained or to start in the lower arch first with removable anterior bite plane in upper arch.

Fifty four subjects with class II division 2 participated in this study. The subjects were randomly divided into two groups; Group one (28 patients): orthodontic treatment with upper arch bond up first and lower arch was bonded when 4 mm overjet was reached. The treatment continued until 0.019 x 0.025 " stainless steel wires were reached in both arches. Group 2 (26 patients): orthodontic treatment with lower arch bond up first with removable anterior bite plane in upper arch. When 0.019 x 0.025" stainless steel wire was reached, the upper arch was bonded. The treatment continued until 0.019 x 0.025" stainless steel wires were reached. Three cephalograms were taken for each patient in both groups; pretreatment (T0) , after bonding the other arch (T1) and at the end of leveling and alignment in both arches (T2). Cephalometric measurements and superimpositions were made. Skeletal and dentoalveolar treatment changes were compared within and between the 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 17 years and ≤ 26 years
* Class II division 2 malocclusion.
* Overjet (OJ) \< 4 mm.
* Overbite (OB) covering more than half of the lower incisor height.
* Mild to moderate crowding with tooth contact displacement no more than 2 mm.
* Good oral hygiene and healthy periodontium.

Exclusion Criteria:-

* Systemic health problems and medications were taken.
* History of previous orthodontic treatment.
A Dose-Ranging Clinical Study to Assess the Safety and Efficacy of Subconjunctival Injection of Sirolimus in Patients With Dry Eye in the Controlled Adverse Environmental (CAE) Model

The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation compared to Placebo on the signs and symptoms of dry eye in the CAE Model.


Eligibility Criteria:
Inclusion Criteria include, but are not limited to:

* Have a reported history of dry eye in both eyes;
* Have a history of use of or desire to use an eye drop for dry eye symptoms within the past 6 months.

Exclusion Criteria include, but are not limited to:

* Have contraindications to the use of the study medications;
* Have known allergy or sensitivity to the use of the study medications or diagnostic dyes;
Hormone Replacement Therapy and Prothrombotic Variants

To examine in postmenopausal women the potential interactions of hormone replacement therapy with other blood clotting factors on the risk of cardiovascular diseases such as heart attack or stroke.

BACKGROUND:

Estrogens are prothrombotic. Recently, the Heart and Estrogen/progestin Replacement Study (HERS), renewed interest in the adverse effects of hormone replacement therapy (HRT). In HERS, HRT was no better than placebo at preventing coronary events. In post hoc analyses, treatment was associated with early harm and late benefit. In an American Heart Association funded case-control study, a potential interaction was observed between HRT and the prothrombin G20210A variant on the risk of first myocardial infarction (MI) in post-menopausal women with hypertension.

DESIGN NARRATIVE:

The study has a case-control design. The Group Health Cooperative (GHC) computerized files will be used to identify postmenopausal women, aged 30 to 79 yrs, with incident myocardial infarction (MI) or stroke during 1/2000-12/2004. Population-based controls, sampled from the GHC enrollment files, will be frequency matched to cases by age, calendar year, and treated hypertension. Data collection will include medical-record review, telephone interview of consenting subjects, and venous-blood collection. Standard methods will be used to assay variant alleles. The GHC computerized pharmacy records will serve as the primary source of information about the use of HRT. Data analysis will involve restriction, stratification, and logistic regression. Case-control and case-only analyses are planned. There will be a total of 600 MI cases, 420 stroke cases and 1800 controls.

The primary purpose is to examine the potential interactions of hormone replacement therapy with other procoagulant variants on the risk of cardiovascular events. The main variants of interest are: (la) factor XIIIA Val34Leu; (ib) platelet glycoprotein (PGP) Jib Ile843Ser; (ic) PGP IIIa Leu33Pro; and (id) PGP Ia C807T. The secondary aims include the assessment of other drug-gene, risk-factor-gene or gene-gene interactions on risk: (2a) the interaction between PGP IIb Ser843, PGP lila Leu33Pro and PGP Ia C807T and traditional cardiovascular risk factors such as smoking and obesity on the risk of MI and stroke; (2b) the interaction between three coagulation factor XIII polymorphisms and PAl-1 4G/5G on the risk of stroke in women; and (2c) the interaction between aspirin use and glycoprotein IIIa Leu33Pro on the risk of MI and stroke.

Eligibility Criteria:
No eligibility criteria
A Study of Weekly Taxotere and Xeloda in Metastatic Breast Cancer

The purpose of this study is to attempt to find better tolerated doses and schedules of this highly effective combination chemotherapy regimen.

Combination chemotherapy has advantages over monochemotherapy due to the higher response rates that can often be obtained; by using agents with non-overlapping toxicity profiles, these responses can be achieved with less toxicity than maximally tolerated doses of single agents. One significant advantage of capecitabine/weekly docetaxel combination chemotherapy is that both agents appear to have a toxicity profile appropriate for palliative therapy of advanced breast cancer. This trial will utilize the usual schedule of capecitabine used in the USA, which is two times per day oral dosing for 14 days but at a reduced dose in hopes of decreasing toxicities. Docetaxel will be given weekly at a dose of 35 mg/m2 X 2 with a one-week rest to coincide with the 14-day schedule of capecitabine.

The primary objective is to evaluate the overall response rate (complete and partial responses) according to the RECIST criteria of the combination of capecitabine and docetaxel with the selected schedule in patients with advanced and/or metastatic breast cancer. The secondary objectives are to evaluate tolerability, time to tumor progression, and time to treatment failure of the combination of capecitabine and docetaxel.

Eligibility Criteria:
Inclusion Criteria:

* Female patients with histopathologically proven metastatic breast cancer.
* Patients 18-75 years old
* Performance status: Karnofsky \> 70%
* Patients must have measurable disease. Patients with only blastic bone lesions are ineligible.
* Adequate bone marrow, liver, renal and cardiac functions defined as:
* Ability to understand the study and give informed consent.
* Patients may not have received more than one prior chemotherapy for metastatic breast cancer. 5-FU or Taxol given as part of an adjuvant regimen will not render the patient ineligible.

Exclusion Criteria:

* Patients with brain metastasis, adequately treated and stable and not requiring continued steroid medication will be eligible if no progression for \> 3 months.
* Patients who have received any anti-cancer investigational agent in the month prior to inclusion.
* Patients previously treated with docetaxel(Taxotere)or capecitabine (Xeloda).
* Patients with lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome.
* Patients with renal impairment (creatinine clearance below 30 ml/min calculated according to Cockcroft and Gault, see Appendix D), since capecitabine is contraindicated in patients with severe renal impairment.
The Clinical Informationist: Does the Model Work

This study is investigating the effects of an established clinical informationist program (evidence-based practice support service in which information professionals with significant clinical knowledge bases and advanced information seeking and appraisal skills) on clinical decision making at selected critical care units at Vanderbilt University Medical Center

Background To evaluate the role of the Clinical Informatics Consult Service(CICS), an informationist service at the Eskind Biomedical Library (EBL) at Vanderbilt University Medical Center (VUMC, in clinical decision-making, the EBL has been awarded a 3-year grant from the National Library of Medicine (5 R01 LM07849-02). The CICS is a well-established program that facilitates evidence-based practice by delivering targeted information in answer to complex, patient-specific questions. The CICS places librarians with specialized training in medical subject areas and in information retrieval ("clinical informationists") on clinical teams in intensive care settings. Acting as expert consultants, they analyze the biomedical literature to identify, filter, and present the best examples of each clinical viewpoint expressed about key problems.

Evaluation Project Working in cooperation with the Center for Evaluation and Program Improvement (CEPI) at Peabody College of Vanderbilt, the investigators will evaluate formally the role of CICS in clinical decision-making and evidence-seeking behavior. While past studies have evaluated clinical medical librarians' roles, few if any studies have examined the effectiveness and utility of the new clinical informationist approach in sites where informationists are well-established.

The project will also create reusable evaluation tools transferable across environments. Through a combination of observation and interviews, investigators will examine librarian involvement in three existing Vanderbilt CICS intensive care units. The project will collect detailed information about the ways in which clinicians incorporate CICS-provided information into their workflows. Next, investigators will conduct a randomized trial to evaluate the effect of CICS on decision-making. Investigators will compare clinicians' intended course of care vs. actual care when CICS results are provided and when clinicians seek information themselves.

Finally, "virtual cases" developed from actual patient CICS-related scenarios in each clinical unit will be incorporated into training tools that can be used to export elements of the CICS model to other locations. Demonstration of the utility of the clinical informationist approach can foster widespread adoption nationally, and increase the degree to which clinical practice becomes evidence-based.

Eligibility Criteria:
Inclusion Criteria:

Evidence-based questions requested by clinician on current service as an attending, resident, fellow, or nurse practitioner on one of the units included in the study

Exclusion Criteria:

All others
Healthy Eating for My Infant (HEMI)

Infants from underserved and minority backgrounds are at increased risk for obesity and poor feeding and nutrition outcomes, but obesity prevention programs tailored specifically to the needs of these infants are lacking. The current study takes a community-engaged approach to development and delivery of an adaptively tailored obesity prevention program delivered via home visiting to target infant eating and feeding (Healthy Eating for My Infant; HEMI).

Poor dietary habits and obesity-risk begin early in infancy. Infants from underserved and minority backgrounds experience disparate rates of poor nutritional outcomes and subsequent health disparities related to obesity. Each infant and their family experiences a unique set of risk factors and barriers to healthy eating. However, obesity prevention programs that are culturally and contextually relevant for underserved families and adapted based on the needs of individual families are lacking. The current study will develop an obesity prevention program, Healthy Eating for My Infant (HEMI), using a community-engaged approach involving community members in development and delivery of the program. HEMI targets healthy infant feeding through six monthly sessions with infants 3-8 months old. The program will be delivered as a supplement to an already existing evidence-based home visiting program, Every Child Succeeds (ECS), serving families with primarily low income and ethnic/racial minority backgrounds.

Development of an adaptive and effective obesity prevention program meeting the needs of underserved infants is critical for addressing health disparities in infant eating and obesity.

Eligibility Criteria:
Inclusion Criteria:

* Infant enrolled in the Every Child Succeeds (ECS) program
* Infant age is \< 2 months at study recruitment
* Infant born at \> 37 weeks gestation
* Infant is a singleton
* Maternal age is \> 18 years (in order to consent for child to participate)
* Mother is fluent in English or Spanish

Exclusion Criteria:

* Infant has a major medical condition that requires specialized feeding