cyrilzakka/clinical-trials huggingface dataset:
Closure of Fasciotomy Wounds: A Prospective, Observational Study of a Continuous External Tissue Expander

Fasciotomy wounds are rarely able to be closed at the time of index surgery. They often require multiple returns to surgery for closure, and occasionally require skin grafting (i.e. they are never completely closed). We are interested in seeing whether this device, which provides constant and gradual tension on the wound, may allow for rapid wound closure in a safe fashion, perhaps even precluding a return trip to surgery.

Null hypothesis #1: The Dermaclose Wound Management System (Woundcare Technologies Inc, Chanhassen, Minnesota) will not result in closure of fasciotomy wounds more rapidly than standard vessel loop techniques.

Null hypothesis #2: The Dermaclose Wound Management System will not reduce the number of return trips to the operating room for surgical procedures related to closure or skin grafting of fasciotomy wounds.

After IRB approval, all patients meeting inclusion criteria and requiring fasciotomy of the arms, legs, or pelvis will be consented for participation in the research study. Patients will either have their fasciotomy wounds closed through application of the Dermaclose device, as per the manufacturer's instructions, or through application of vessel loops with staples in a "shoestring technique" as described in the literature (1). Choice of wound closure technique will be at surgeon discretion. All patients will undergo application of a vacuum-assisted wound closure device (Wound VAC, Active Healing Solutions Inc, San Antonio, TX), which is standard of care for temporary coverage of open wounds (2, 3). Patients will be returned to the operating room every 2-3 days until wound closure or skin grafting has been accomplished. If skin closure is not accomplished in the operating room, but occurs prior to return trip to the operating room, then definitive suture closure of the wound will be performed under local anaesthetic, followed by removal of the Dermaclose device or of the vessel loop with staple shoestring. Decisions regarding wound closure or skin grafting in the operating room will be left to the judgment of the attending surgeon.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Patients undergoing fasciotomy for decompression of compartment syndrome, evolving compartment syndrome, or prophylactically to prevent compartment syndrome

Exclusion Criteria:

* Patient younger than 18 years of age
* Patients with an active infection
* Patients unable to comply with protocol
Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy

This phase II study is to evaluate the safety and efficacy of Ferinject® in reducing perioperative transfusion in iron deficiency anemia patients anticipating pancreatoduodenectomy.

Primary objectives : Perioperative transfusion rate (including preop, intraop, postop≦7 days).

Secondary objectives : Postoperative complication, hospital stay, change of hematological parameters (Hb, ferritin, transferrin saturation (TSAT) change after Ferinject® injection), adverse effect with Ferinject® injection.

Eligibility Criteria:
Inclusion Criteria:

* ≥19 years old
* anticipating PD
* preoperative Hb of Female 7.0-11.9g/dl and Male 7.0-12.9g/dl
* signed written informed consent

Exclusion Criteria:

* a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient
* hypersensitivity to any component of the formulation
* active severe infection/inflammation
* history of transfusion, erythropoietin, \>500 mg intravenous iron administration within 4 weeks prior to screening.
* history of acquired iron overload.
* MCV \> 95µm3 or TSAT \> 35%
* patients with preoperative Hb\<7 g/dl
* pregnancy or lactation
* decreased renal function (defined as creatinine clearance \<50 L/min/1.73m2calculated by eGFR(MDRD))
* chronic liver disease or increase of liver enzymes (ALT, AST) \>5 times the upper limit of normal range
An Efficacy of Simulator Training for Fiberbronchoscopy in Intensivists

We evaluated the effects of different fiberbronchoscopy training in how to teach and assess performance. Resident participants with no experience of fiberbronchoscopy, and doctors with little clinical experience with fiberbronchoscopy were eligible for the study.

Participants who passed the theory test were enrolled in the study, and two training simulators for fiberbronchoscopy were used. After randomization, participants were enrolled in Group A (Bronchoscopy training simulator LM-092 )and Group B(The BRONCH Mentor). The test will be taken after practice at the appropriate time.

Eligibility Criteria:
Inclusion Criteria:

Doctors with little experience of fiberbronchoscopy

Exclusion Criteria:

* Resident participants who can not complete the study.
* Resident participants who can not pass the theroy examination.
Photobiomodulation for Concussions: the Use of the ImPACT® Test as an Assessment Tool

Brain photobiomodulation (PBM) therapy is an innovative modality for the stimulation of neural activity in order to improve brain function and is currently under investigation as a treatment for several diverse neurological disorders. Our emphasis on this study is to review the use of PBM as a treatment modality for concussions and the use of ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) test to assess improvement in cognition and symptomatology in patients with post-concussion syndrome (PCS) treated with PBM.

* This will be a retrospective, single arm, unmasked, clinical study.
* Data scores will be collected for patients who initially underwent the Workplace Post-Injury 1 test of the ImPACT® test system prior to PBM treatment.
* Patients were treated with photobiomodulation using the BIOFLEX® DUO+ system that utilized a 180 bulb Light Emitting Diode (LED) array followed by laser probes. Both delivery methods were applied to the cervical spine and the cranium, and both entailed the use of red light at 660 nm wavelength and near-infrared light at 830-840 nm wavelength. Treatment is provided three times per week on alternating days with weekends off for 4 weeks for a total of 12 treatments utilizing Health Canada approved device specific protocol guidelines for treatment of the cervical spine.
* Data scores will be collected for a second ImPACT® test using the Workplace Post-Injury 2 test.
* Results of the Post-Injury 1 test and the Post-Injury 2 test will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 15-65 years clinically diagnosed with a mild Traumatic Brain Injury by a health professional and currently not undergoing any treatment during a 1 year period from January 2018 to December 2018.
* Documentation of the history of a qualifying mild Traumatic Brain Injury within 3 months of traumatic incident and/or diagnosis with persistent symptomatology after 3 months. For reference, International Classification of Diseases, Tenth Revision (ICD-10) clinical criteria require a history of TBI and the presence of three or more of the following eight symptoms: 1) headache, 2) dizziness, 3) fatigue, 4) irritability, 5) insomnia, 6) concentration or 7) memory difficulty, and 8) intolerance of stress, emotion, or alcohol4.

Exclusion Criteria:

* Any positive findings on imaging studies
* A diagnosis of or a family history of neuropsychiatric co-morbidity.
* Any additional diagnoses compounding the diagnosis of a concussion or mild traumatic brain injury (TBI)
* Currently undergoing any type of therapy
SJM MRI Diagnostic Imaging Registry (IDE)

This study is a prospective, non-randomized, multi-center study of subjects implanted with an SJM pacemakers, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices who are clinically indicated for a non-thoracic MRI scan.

This study will be performed as part of a regulated, prospective, non-randomized, multi-center clinical study.

Subjects will be enrolled, undergo a clinically-indicated MRI scan, and have an assessment of adverse events, device measurements, and clinical utility of the MRI scan images.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is implanted with a market-released St. Jude Medical pacemaker, ICD, or CRT current generation device listed in the study protocol and any market-released pacing or defibrillation lead.
2. Patient's device and all leads must be implanted for at least 6 weeks prior to the scheduled date of the MRI.
3. Patient has a clinical indication for a non-thoracic MRI scan, where MRI is the imaging modality of choice that will give adequate results to manage the patient.
4. Patient is scheduled for a non-thoracic MRI scan up to 1.5T.
5. Patient has a pacemaker, ICD, or CRT device implanted pectorally.
6. Patient has the ability to provide informed consent for study participation and be willing and able to comply with the study procedures.
7. Patient is 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

1. Patient has an ICD/CRT-D and is pacemaker dependent
2. Capture threshold is greater than 2.5 volts at 0.5 ms for RA and RV leads
3. Pacing lead impedance is NOT within range (i.e. ≥ 200 and ≤ 2000 ohms)
4. High voltage lead impedance (HVLI) is NOT within range (i.e. ≥ 20 and ≤ 200 ohms)
5. Patient has a device generator battery voltage at elective replacement interval (ERI)
6. Patient has another existing active implanted medical device (e.g. neurostimulator, infusion pump, etc.) that has MR labeling that will not allow the MRI scans to be completed.
7. Patient has other non-MRI compatible device or material implanted

   NOTE:
   * MRI compatible knee replacements, hip replacements, stents, etc. may be included as long as the labeling of these devices allow MRI scans conducted per this protocol
   * MRI compatible mechanical, prosthetic, and bioprosthetic heart valves may be included as long as the labeling of these devices allow for MRI scans conducted per this protocol
   * Non-removable dental implants may be included
8. Patient has a lead extender, adaptor, or capped/abandoned lead
9. Patient is pregnant
Effects of Innovative Aerobic Exercise Training in Cystic Fibrosis

The main objective of this study is to compare the effectiveness of two different exercise interventions in a patient-centered, home-based exercise program for improving cardiorespiratory-fitness in people with cystic fibrosis (CF). We hypothesize cystic fibrosis patients participating in a high intensity interval training (HIIT) group will experience greater improvements in cardiorespiratory-fitness than those in a moderate continuous training (MCT) group. Further, we plan to investigate the efficacy of the comparators on patient-centered outcomes.

This study is a randomized control trial that compares MCT to HIIT using a patient-centered and home-based delivery model with CF Care Centers in the United States. Participants will be randomly allocated to either an MCT or HIIT arm. Both the MCT and HIIT interventions are accepted forms of prescribed exercise in clinical practice. The interventions will be delivered with a telehealth platform using internet (HIPAA-Compliant video), phone, and email/text support. All study sites will receive initial and on-going training and program facilitation to assure consistency of delivering the intervention. All participants across both arms visit their respective CF clinics on a regular basis for routine CF care. Thus, our research team will be able to coordinate all testing/assessment visits, including long-term (18-month timepoint), with participants throughout the study. The primary and secondary outcomes include important patient-centered outcomes as selected by our study's CF Patient and Stakeholder Advisory Board.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with Cystic Fibrosis
* Prescribed and taking for 28 days ivacaftor-tezacaftor-elexacaftor (Trikafta)
* 18 years and older

Exclusion Criteria:

* 17 years of age or less
* not eligible for ivacaftor-tezacaftor-elexacaftor (Trikafta)
* inability to exercise
* pregnancy
* status post lung transplantation
* already participating in more than 150 minutes of aerobic exercise per week
Immune Reconstitution in Tuberculosis Disease

The aim with study is to provide adjunctive therapy with vitamin D and phenylbutyrate together with standard anti-tuberculosis treatment to significantly improve clinical recovery among patients with untreated, active pulmonary tuberculosis.


Eligibility Criteria:
Inclusion Criteria:

HIV negative patients, adult patients \>18 years who has not started anti-TB therapy.

Newly diagnosed pulmonary TB confirmed by microscopy or culture but also sputum-negative clinical TB cases (defined according to the WHO 2006 criteria for sputum smear-negative TB ie. clinical symptoms of TB, chest X-ray findings and response to standard treatment).

Exclusion Criteria:

Patients who have already started treatment with anti-TB drugs for more that 5 days.

HIV-positive patients.

History of anti-TB treatment in the past 2 years.

Local extra-pulmonary TB in the absence of lung manifestations.

Hypercalcaemia (serum calcium \> 3 mmol/L) identified at baseline.

Pregnant and breast feeding women.

Any known liver or kidney function abnormality, malignancy or patients treated with cardiac glycosides.
Autologous Stem Cell Transplant (ASCT) With Intravenous Busulfan and Melphalan as Conditioning Regimen

Analyze the results of ASCT using intravenous Busulfan and Melphalan as conditioning regimen for patients with Multiple Myeloma.

Primary Efficacy and safety of the procedure in terms of number of remissions, survival, event-free survival, relapse risk, and early transplant-related mortality (up to day +100).

Secondary Graft kinetics (time to neutrophil and platelet recovery after ASCT) 2.Analyze the presence of transplant-related complications (infections, sinusoidal occlusive syndrome and others) 3.Analyze prognostic factors for engraftment, remission rate, relapse risk, disease-free and overall survival after ASCT

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic multiple myeloma
* Male or female subject age \>= 70 years
* The subject has received at least one previous line of therapy including:
* Front-line treatment with VBMCP/VBAD or VAD or second-line therapy with regimens including bortezomib, thalidomide or lenalidomide
* The subject has given voluntary written informed consent

Exclusion Criteria:

* Use of bortezomib, thalidomide or lenalidomide as front-line therapy
* ECOG satus \>=2
* Left ventricular ejection fraction \<40%
* DLCO and FVC \<39% theoretical value
* Abnormal liver function(total bilirubin \> 2 mg/dL and/or ALT or AST \> 3 x ULN)
* Serum creatinine at transplant \>1.6 mg/dL and/or creatinine clearance \< 65 mL/minute
* Subject has an active systemic infection requiring treatment
* Subject had a myocardial infarction within 6 months of enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrythmias
* Subject has any other serious medical condition (severe hepatic impairment, pericardial disease, acute diffuse infiltrative pulmonary disease) or psychiatric illness that could potentially interfere with the completion of treatment of this protocol
* Subject is known to be immunodeficiency virus (HIV)-positive
* Subject has received an experimental drug or used and experimental medical device within 4 weeks before enrollment
* If female, the subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative pregnancy test at screening. Pregnancy testing is not required for postmenopausal or surgically sterilized women
Perioperative Oral Steroids for Chronic Rhinosinusitis Without Polyps (CRSsNP)

While oral steroids have been shown to be effective in the management of patients with chronic rhinosinusitis with polyps, its role in treating chronic rhinosinusitis without polyps (CRSsNP) is ambiguous. Despite a lack of strong clinical evidence to suggest a benefit in this disease state, steroids are often prescribed as a component of post-operative care after sinus surgery for patients without polyps. Oral steroids carry with them significant adverse effects, and should be prescribed thoughtfully. The aims of this study are to determine if oral steroids in the peri-operative period improves patient outcomes in CRS without polyps.


Eligibility Criteria:
Inclusion Criteria:

* CRSsNP as defined by Clinical Practice Guideline (Update) on Adult Sinusitis
* scheduled to undergo endoscopic sinus surgery

Exclusion Criteria:

* chronic rhinosinusitis with polyps (CRSwNP)
* Aspirin exacerbated respiratory disease
* Cystic fibrosis
* Immunosuppressive states (Human immunodeficiency virus, transplant)
* Oral steroid use within 30 days of surgery
Comparison the Effect of Uterine Closure Technique Difference on Uterine Niche After Caesarean Delivery.

Caesarean section scar may have result as isthmocele or scar detachment during pregnancy which is in few years after previous delivery. Uterine niche is the most effectively used measurement side of uterus to estimate for these detachment complications. The aim of this study is to support this niche site by supporting the classical uterine closure technique.

Cesarean delivery rate continues to increase in world in concern with uterine scar complications as placental invasion abnormalities, isthmocele or previous scar detachment during pregnancy (post surgical long term complications). Uterine niche is the presence of a hypoechoic area within the myometrium on the lower uterine segment, showing a defect of the myometrium at the site of a previous cesarean delivery. Some surgical techniques have been trying to support this area to prevent the post surgical long term complications. In this study the investigators have been trying to find out a new technique by applying supporting sutures during uterine closure in cesarean section. Three months after the surgery, the uterine niche measurement will be examined with ultrasonography for both study and classical groups and results will be compared between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Primigravid elective caesarian delivery candidates
* The participants will have not any uterine contraction or cervical dilatation before delivery.
* Having no systemic or obstetric illnesses
* Participants who are accept to participate in this study with their written consent.

Exclusion Criteria:

* Previous caesarian delivery
* Having uterine contraction or cervical dilatation
* Smoking cigarettes
* Having systemic or obstetric illnesses
TRJ Post Market Clinical Follow Up

Clinical and radiological 2 years results of TRJ® Hip Stem.


Eligibility Criteria:
Inclusion:

* TRJ® implantation performed
* patient consent available for participation in the study

Exclusion:

* permanent cortisone therapy
* alcohol or drug abuse
Influenza Burden Assessment in the United States, July1997 - up to April 2009

The study will assess the burden of severe influenza outcomes by age, risk status, and influenza subtype, in order to create a profile of the burden of influenza-related morbidity and mortality in United States from July 1997 to April 2009.

This epidemiological study is a modelling of time series retrospectively extracted from multiple databases. Data will be extracted from existing electronic healthcare databases.

Eligibility Criteria:
Inclusion Criteria:

* Recorded in the US NIS hospitalization data or the US National Vital Statistics System (NVSS) mortality data with a pre-specified diagnostic code.

Exclusion Criteria:

* Missing data in the following fields: age, primary discharge diagnosis, admission month (NIS) /month of death (NVSS), and status at discharge (alive / dead).
Study to Evaluate Additional Risk Minimisation Measures (aRMMs) for REBLOZYL Among Healthcare Professionals (HCPs)

This is a non-interventional post-authorization safety study (PASS) employing a cross sectional design to evaluate the effectiveness of the additional risk minimization measures (aRMMs) for REBLOZYL. A survey will be used to measure the knowledge and comprehension of the REBLOZYL aRMMs among European Economic Area (EEA) based healthcare professionals (HCPs). The PASS will be conducted among HCPs in a representative sample of EEA countries where REBLOZYL is commercially available, potentially including Austria, Germany, Italy, Norway, Sweden, the Netherlands, Poland, and Spain. Additional EEA countries may be included, as needed, based on commercial availability and reimbursement status.


Eligibility Criteria:
Inclusion Criteria:

* Healthcare professionals (HCPs) experienced in treatment of haematological diseases who may intend to prescribe REBLOZYL in the participating European countries and were on the target group for dissemination of the additional risk minimization measures (aRMMs).
* The HCP provides permission to share their responses in aggregate with European Medicines Agency (EMA) or National Competent Authorities (NCAs), if requested.

Exclusion Criteria:

* HCPs who previously participated in the cognitive pre-testing of the survey questionnaires to be used for the study.
* HCPs who have been direct employees of the marketing authorization holder (MAH), the EMA, or the study vendor within the past 5 years.
Pharmacokinetics of BPDO-1603 or BPDO-16031 and BPDO-16033 Administration in Healthy Adults

Pharmacokinetics and safety of BPDO-1603 or BPDO-16031 and BPDO-16033 administration in healthy adults. Randomized, open-label, single-dose, cross-over, Phase 1 study


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults aged 19 or older and 55 or less at the time of screening tests
2. Men weigh 55 kg or more and women weigh 50 kg or more
3. Those with a body mass index of 18.5 kg/m2 or more and less than 27.0 kg/m2

Exclusion Criteria:

1. Clinically significant active chronic diseases, hepatometer (severe liver disorder, etc.), kidney (severe kidney disorder, etc.), and nervous system (hepatorespiratory tract patients). Parkinson's disease, immune system, respiratory system (asthenia, obstructive pulmonary disease, etc.), urinary system, digestive system (digestive ulcer, etc.), endocrine system, blood/tumor, cardiovascular system (cardiac infarction, heart failure, uncontrolled hypertension, atrioventricular junction disorder, etc.), or have a history.
2. A person who has a serious urinary tract infection due to renal tubular acidosis, etc. or has a history of history
3. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Safety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients With Bipolar Depression

The purpose of this study is to evaluate the efficacy and safety of quetiapine in the treatment of a major depressive episode in patients with bipolar disorder.


Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent;
* Bipolar disorder with most recent episode depressed;
* Outpatient status

Exclusion Criteria:

* Patients with a current Axis I disorder other than bipolar disorder within 6 months of screening;
* Patients whose current episode of depression exceeds 12 months or is less than 4 weeks
Normobaric Hypoxic Training and Multiple Sclerosis

To study the effects of normobaric hypoxic training on cardiorespiratory fitness, resting, postprandial and exercise activity energy expenditure, immunoregulatory functions and serum erythropoietin levels in relapsing-remitting multiple sclerosis patients.


Eligibility Criteria:
Inclusion Criteria:

* stable immunomodulatory therapy
* expanded disability status scale score \< 4.5
* body mass index 18.5 - 29.9 kg/m2

Exclusion Criteria:

* clinically relevant heart, lung, liver, and kidney diseases