cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of a Peer Visitation Program to Improve Patient Activation and Quality of Life During Amputation Rehabilitation

There is no known interventional clinical trial evidence for existing support and the reintegration strategy of a peer visitation program following amputation. The Amputee Coalition Peer Visitation Program is the only national and VA recognized program for amputees, however, it has not been rigorously tested for effectiveness. Therefore, the objective of this study is to demonstrate the Amputee Coalition Peer Visitation Program (AC PVP) will improve functional outcomes for Service Members, Veterans, and civilians during amputation rehabilitation.

In the fields of medicine and public health management, navigation and peer visitation programs consider patients as are their own important resources, who should be actively involved in the health care organization and throughout the process of care delivery and rehabilitation. The importance of promoting a more active role of patients in the management of their own health care is recognized by health care experts, managers, and policy makers. Programs that engage patients in their own health care are reported as an important strategy to improve adherence, outcomes, satisfaction toward the health care provider, and reduction of health care costs. The emotional adjustment to an amputation is sometimes the most challenging part. Peer visitation allows the patient to speak directly with another amputee who has shared a similar experience, allowing them to relate feelings and concerns about the loss of a limb to someone who has already endured the process and lives with the condition daily.

There is increasing national and international interest in patient education programs. The ultimate anticipated outcome for individuals attending these programs is improvement in quality of life. Patient empowerment, self-efficacy, and self-management have also been found to be key intermediate outcomes of acute amputation rehabilitation, but have been somewhat difficult to operationalize, measure, and subsequently report in terms of patient impact. There is no known interventional clinical trial evidence for existing support and the reintegration strategy of a peer visitation program following amputation.

The Amputee Coalition Peer Visitation Program is the only national and VA recognized program for amputees, however, it has not been rigorously tested for effectiveness. Therefore, the objective of this study is to demonstrate the Amputee Coalition Peer Visitation Program (AC PVP) will improve functional outcomes for Service Members, Veterans, and civilians during amputation rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Any candidate for lower extremity amputation
* Any immediate post operative lower extremity amputation within 7 days of amputation
* Willing and able to comply with the study protocol
* Able to provide informed consent
* Male or female, of any ethnicity
* 18 - 75 years of age
* Any body weight

Exclusion Criteria:

* Any level of amputation other than lower extremity
* Known cognitive impairment
* Does not speak English
Comparison of Educational Methods for Teaching Peripheral Blood Smears

This is a prospective, randomized controlled, crossover trial comparing the effectiveness one two curricular designs to teaching peripheral blood smears to residents.

General Approach:

This study will employ a randomized, controlled design and will use as its outcomes two separate post-tests, one after the first teaching session and one 4 weeks after the second intervention.

Design The investigators are attempting to find whether the combination of basic science education using an 1-hour additive microskills- building method along with compare/ contrast model versus a 1-hour traditional case-based format would improve performance on a visual recognition test of hematology questions. A final test at 4 weeks after the cross-over between the two groups will also help investigators analyze whether the order of exposure to the teaching method would have an impact on the final performance.

Sampling, including sample size and statistical power:

Sample size will be between 40-50 resident physicians meeting inclusion criteria for the study. There is not enough data in the literature to effectively determine power, so we will use a convenience sample of the largest feasible group (around 40).

Collection of data:

Data will be collected on an excel spreadsheet and will be permanently de-identified on that spreadsheet; it will be kept on a password-protected site.

Information management and analysis software:

Data will be entered into a password protected excel spreadsheet and each study participant will be assigned a unique identifier code which will be used to link the data. Statistical analysis will be performed using SPSS version 20.

Data entry, editing and management, including handling of data collection forms, different versions of data, and data storage and disposition:

Paper surveys and tests will be collected, recorded and locked; they will be destroyed 2 years after termination of the study. A paired t-test will be used to compare the two samples means for significance.

Quality Control / Assurance:

Pretest and post-tests will be checked against a gold standard, a hospital board-certified hematopathologist, to check the quality of the slides.

Bias in data collection, measurement and analysis:

Given the small numbers of participants expected, a Type 1 error (failure to detect a difference in groups when one exists) is possible, as the study will possibly be underpowered.

Eligibility Criteria:
Inclusion Criteria:

* Internal medicine and Family Medicine residents and faculty at The Reading Hospital and Medical Center having completed medical school

Exclusion Criteria:

* Practicing/ board certified hematologists
Selected Lysosomal Enzyme Activities and the Oxidant-antioxidant Balance in Hyperbaric Oxygen Condition.

The aim of the research project was to investigate the effects of hyperbaric oxygen (HBO) treatment on the redox equilibrium in individuals with different pathological conditions. Both hyperbaric oxygenation and the pathological condition are associated with redox imbalance (oxidative stress), however, HBO is successfully used in the treatment of chronic wounds, e.g., diabetic foot syndrome, as well as in sudden and acute hearing loss, e.g., acute acoustic trauma or idiopathic sudden sensorineural hearing loss.

The study involed in sudden sensorineural hearing loss (SSNHL) patients, individuals with difficult-to-heal skin wounds following mechanical injuries, and diabetic foot patients. HBO therapy, which involved inhalation of 100% oxygen at a pressure of 2.5 atm, consisted of 14-30 sessions depending on the clinical case. The study material was venous blood drawn three times: before and after the first session, and after the last HBO procedure. The following variables were evaluated: the concentrations of thiobarbituric acid reactive substances (TBARS), malondialdehyde (MDA) and conjugated dienes (CD) in plasma and erythrocytes, the activities of catalase (CAT), superoxide dismutase (SOD) and glutathione peroxidase (GPx) in erythrocytes, as well as, blood counts.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent form for participation in the study

Exclusion Criteria:

* other pathological conditions (disorders, wounds, diseases)
* bad feeling of the participant on the day of the study,
* refraining from smoking, drinking alcohol, and the consumption of any dietary supplements that can affect the oxidant-antioxidant balance.
Open-Label Study to Evaluate the Immunogenicity of Bovine Collagen in ArteFill® by Skin Testing

The purpose of this study is to assess the clinical utility of the ArteFill® pre-treatment Skin Test in predicting and preventing hypersensitivity reactions to treatment with ArteFill® implant

This is a single-center, open-label study in approximately 485 healthy male and female subjects to obtain 450 evaluable subjects. In this protocol, an ArteFill® Skin Test study will be conducted to evaluate the test's clinical utility to determine the incidence of positive skin reactions to ArteFill®. The results of this skin test study will determine if the risk of a hypersensitivity reaction against ArteFill® without a skin test is no greater than the published historical risk of a hypersensitivity reaction against a Zyderm or Zyplast treatment after a patient demonstrates a negative response to a single Zyderm skin test. Based on prior clinical experience with ArteFill® implant in commercial use outside the United States, it is anticipated that no reactions will be observed. As such, it may be suggested that there is no practical use of the ArteFill® Skin Test for screening patients, and therefore, the test may be eliminated as a requirement prior to treatment with the ArteFill® product as is the clinical practice outside the United States.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years of age or older, male or female.
* Subjects who are healthy and have normal skin on the volar surface of the forearm.
* Subjects willing and able to comply with the requirements of the study.
* Subjects willing and able to comply with the follow-up requirements.
* Subjects willing and able to give written and verbal informed consent.

Exclusion Criteria:

* Subjects who are pregnant, nursing or intend to become pregnant.
* Subjects who have had any form of collagen soft tissue treatment within the last 12 months.
* Subjects who were or are currently being treated with any systemic immunosuppressive therapy including but not limited to chemotherapy agents or corticosteroids (including inhaled or insufflated) within the past 3 months.
* Subjects who were or are currently being treated with any topical OTC drug or prescription therapy on their arms (below the elbow) within the past 3 months.
* Subjects with a history indicative of abnormal immune function (e.g. auto- immune diseases, HIV, cancer, etc).
* Subjects with known lidocaine hypersensitivity.
* Subjects with known sensitivity to bovine collagen.
* Subjects who have a history of dietary beef allergy, undergoing desensitization to beef products or planning to undergo desensitization within the study evaluation period.
* Subjects with severe allergies manifested by a history of anaphylaxis.
* Subject is currently enrolled in an investigational drug or device study.
* Subject has received an investigational drug or an investigational device within 30 days prior to entering this study.
* Subject has any skin pathology or condition that could interfere with the evaluation of the treatment areas.
Non-invasive Prediction of Thermal Strain in Healthy Male Adults

This is primarily an experimental study investigating methods of temperature measurement / heat strain detection. In the calibration study, there are different skin temperature sensor types, and in the prediction study there are different methods for determining heat strain, including conventional methods (rectal, gastro-intestinal), the development of a prediction model, and an index based on heart rate variability.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy males
* aged 18-45 y
* regularly participate in sport, exercise, or equivalent physical activity on a weekly basis.

Exclusion Criteria:

* Known injuries or illnesses that may affect safe participation. These include injuries or illnesses involving (but not limited to):
* cardiovascular, renal, or gastrointestinal tract
* heat or exercise intolerance
* acute infections,
* immunological diseases (including asthma)
* psychiatric disorders.
* Participants must not be currently or previously on cardiovascular-related medication and must not be taking psychotropic medication (last 60 days).
Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors

The purpose of this study is to assess the safety, establish the maximum tolerated dose (MTD) and generate pharmacokinetic profiles of BSI-201 after IV administration in adult subjects with histologically documented advanced solid tumors that are refractory to standard therapy or for which no standard therapy is available. Additionally, the safety and tolerability and clinical response of BSI-201 + irinotecan will be investigated in patients with metastatic breast cancer in the phase 1b portion of the study.

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically documented, advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available.
* ECOG performance status of 0, 1, or 2
* Adequate hematological status
* Any prior toxicity from prior chemotherapeutic treatment recovered to grade 1 or grade 0
* 18 years of age or older
* Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form
* For phase 1b portion only: metastatic breast cancer

Exclusion Criteria:

* Hematologic malignancies
* Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids
* Myocardial infarction within 6 months of study day 1, unstable angina, congestive heart failure with NYHA \> class II, uncontrolled hypertension
* Known positive test for HIV or hepatitis C virus, or chronic active hepatitis
* Major surgery within 1 month of study day 1
* History of second neoplasm, except for curatively treated non-melanoma skin cancer, carcinoma in situ of the cervix and other primary cancer with no known active disease present and no curative treatment administered for the last 3 years
* History of seizure disorder or currently on anti-seizure medication
* Systemic chemotherapy or radiation therapy within 28 days of study day 1
* Antibody therapy for treatment of underlying malignancy within 1 month of study day 1
* Evidence of liver disease shown by elevated enzymes
* Evidence of renal disease shown by serum creatinine \> 1.5 x upper limit of normal
* Currently receiving platelet of GCF support for any medical condition
* Concurrent use of herbal medications taken with the intent to treat cancer
* Enrolled in or not yet completed at least 30 days since ending other investigational device or drug study
Analysis of Radiographic and Kinematic Features in FAI Patients

The goal of this observational study is to describe the radiographic and kinematic features in patients with femoroacetabular impingement syndrome (FAI). The main questions it aims to answer are:

* Is structural knee abnormalities associated with knee pain symptoms in FAI patients?
* Does FAI patients with knee pain demonstrate unique kinematic characteristics？ Participants will receive routine preoperative radiographic examinations, which include ipsilateral knee MRI for the purpose of femoral version measurement. Participants will also receive markerless motion capture analysis.

Researchers will compare preoperative radiographic and kinematic features based on knee pain status, which is routinely collected as part of clinical investigation procedures.

This observational study aims to study the association between preoperative subjective knee pain and baseline knee radiographic and kinematic characteristics. MRI of the ipsilateral knee is screened for structural abnormalities, including cartilage defects, meniscal tears and ligament injuries. Markerless motion capture data are evaluated for transverse plane kinematic features, with a primary focus on foot progression angles during normal gait.

Eligibility Criteria:
Inclusion Criteria:

* (1) diagnosed with FAI based on clinical and radiographical findings;
* (2) failed conservative treatment for at least 6 months and indicated for surgical treatment;
* (3) received routine preoperative hip and ipsilateral knee MRI.

Exclusion Criteria:

* (1) history of fracture or surgery of hip and knee;
* (2) avascular necrosis;
* (3) Legg-Calve-Perthes disease;
* (4) Ehlers-Danlos syndrome;
* (5) pigmented villonodular synovitis (PVNS);
* (6) osteoid osteoma (OO);
* (7) synovial chondromatosis;
* (8) severe hip osteoarthritis (OA) with Tönnis grade \> 1;
* (9) developmental dysplasia of hip (DDH)
Handheld Echocardiography in Clinical Practice

Transthoracic echocardiography (TTE) represents an established and fundamental tool for the evaluation of patients with known or suspected cardiovascular disease. Recently, manufacturers have developed handheld echocardiograms small enough to fit in the pocket of a physician's lab coat. Studies assessing these handheld devices have several limitations. While they have generally evaluated the handheld devices favorably, previous studies has not consistently studied handheld devices under the best possible clinical conditions and have not necessarily highlighted the devices' limitations.

In this proposal, we seek to analyze the applicability of handheld echocardiograms to standard clinical practice. The investigators plan to use trained sonographers to perform handheld examinations on patients referred for TTE without established cardiovascular disease. The handheld images will be interpreted by experienced, consultant-level echocardiographers. The investigators then plan to compare findings from the handheld echocardiogram to the patient's standard clinical TTE.


Eligibility Criteria:
Inclusion criteria

* Adult patients referred for a resting transthoracic echocardiogram.

Exclusion criteria

* Referral for quantitative assessment of valvular heart disease
* Referral for strain imaging
* Referral for measurement of left atrial mechanical function or cardiac resynchronization studies
* Known diagnosis of congenital heart disease, restrictive cardiomyopathy, constrictive pericardial disease, or pulmonary hypertension
* Patients who have received left ventricular assist devices or those who have undergone cardiac transplants
The Effectiveness of a Mechanical Debridement Instrument in Reducing Bioburden in Chronic Wounds

This prospective clinical trial will compare the bacterial burden in the wound bed and on the periwound skin before and after mechanical debridement with EZ Debride using fluorescence imaging.

After consenting, the ulcers of eligible subjects are measured, photographed and undergo the MolecuLight imaging procedure (MLiX). The ulcer is mechanically debridement with the EZ Debride device after which a second MLiX procedure is performed. The investigator will then compare the two images.

Acute and chronic wounds burden healthcare systems across the globe. In the United States the cost of nonhealing wounds approximates 100 billion dollars.1-3 The presence of bacteria in and around the wound impedes wound healing. Clinicians treat elevated wound bacterial levels with mechanical and sharp debridement, topical antiseptics and systemic antibiotics. However, evidence on the best methods to reduce bacterial load is lacking. The EZ-1 clinical trial will utilize the latest fluorescence imaging technology to investigate whether mechanical debridement using the EZ Debride® tool reduces bacterial burden.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients with acute or chronic wounds that have been present for a minimum of 4 weeks.
2. A signed and dated informed consent form.
3. Subject is willing and able to comply with instructions and scheduled visits.

Exclusion Criteria:

1. The Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety.
2. The subject's wound has not been present for at least 4 weeks.
Effects of Nocturnal Non-invasive Ventilation on Energy Expenditure in Patients With Severe Chronic Obstructive Pulmonary Disease

It has been shown, that in patients with very severe chronic obstructive pulmonary disease (COPD) the additional use of non-invasive ventilation during pulmonary rehabilitation (PR) may enhance the benefits of PR. It is assumed that the non-invasive ventilation techniques provides a better recovery of the respiratory pump during the night. If non-invasive ventilation also decreases the metabolic demands during night is unknown and is aim of this study. During a 3 week inpatient pulmonary rehabilitation program a total of 85 patients with chronic obstructive pulmonary disease stage IV will be recruited for this study. There will be a 4:1 distribution into 2 groups. 68 patients with an indication for the use of a non-invasive ventilation will be involved in the intervention group where non-invasive ventilation will be initialized. 17 patients with chronic obstructive pulmonary disease stage IV without an indication for the use of non-invasive ventilation will be involved in a control group to detect the changes in nocturnal energy expenditure produced by pulmonary rehabilitation alone. All outcome measurements will be performed during day 1-3 and will be repeated after 12 days (with or without non-invasive ventilation) at day 15-17 of the pulmonary rehabilitation program.

A sub-trial of this study is to validate night movement accuracy of the Dynaport activity monitor with the observations made by a night-vision camera in the sleep lab. This will be performed in study participants as well as in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria for Intervention group:

* chronic obstructive pulmonary disease stage IV
* indication for the use of a nocturnal non-invasive ventilation (according to the German guidelines Schoenhofer et al. 2008)
* patient has not yet used non-invasive ventilation at all or inadequately (less than 3 hours per day)

Exclusion Criteria for Intervention group:

* acute exacerbation of chronic obstructive pulmonary disease
* severe heart failure
* body-mass-index \>35 m²/kg
* fever

Inclusion Criteria for control group:

* chronic obstructive pulmonary disease stage IV (- healthy volunteers are also eligible for the sub-trial of this study to validate night movement accuracy of an activity monitor)

Exclusion Criteria for control group:

* acute exacerbation of chronic obstructive pulmonary disease
* indication for the use of a non-invasive ventilation
* severe heart failure
* body-mass-index \>35 m²/kg
* fever