cyrilzakka/clinical-trials huggingface dataset:
Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections

The purpose of this study is to assess the efficacy and safety of delafloxacin administered as IV and oral formulation in comparison with Best Available Therapy (BAT) in patients with superficial or deep incisional surgical site infection following a cardiothoracic/related leg or abdominal surgery.

This is a randomized, observer-blinded, active-controlled, parallel-group, multicenter, phase IIIb study for the treatment of incisional, superficial or deep, surgical site infection after cardiothoracic /related leg or abdominal surgery (i.e patients who are at risk of microbiologically resistant infections). IV to be switched to oral delafloxacin will be compared to treatments that represent the best available therapy (BAT) for either cardiothoracic/related leg or abdominal surgical site infection (SSI).

Approximately 600 male and female eligible patients will be randomly assigned in a 1:1 ratio to receive delafloxacin or BAT. For patients who are randomised to BAT, the investigator will choose one out of two treatments available (two available for the cardiothoracic/related leg and two available for abdominal SSI) as most appropriate for patient characteristics and local epidemiological pattern.

Duration of study depends on treatment duration (range: minimum 5 to maximum 14 days, as per Investigator's judgment) followed by visits up to 30 days after end of treatment.

Patients will be hospitalized from Screening (within 30 days from surgery) and will remain hospitalized until considered improved or cure as per Investigator's judgment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged more than 18 years.
* Patients with a history of cardiothoracic / related leg or abdominal surgery, occurred within 30 days and no implant is left in place, and a diagnosis of superficial or deep SSI according to the CDC definition.
* The severity of infection requires an IV treatment and patient hospitalization according to the Investigator's judgment.

Exclusion Criteria:

* Previous IV antimicrobial therapy exceeding 24-hour duration during 72 hours prior to first dose.
* Any infection expected to require systemic antimicrobial agents other than study treatment(s).
* Medical history of significant hypersensitivity or allergic reaction or contraindication to the study drugs
* Medical history of central nervous system (CNS) disorders
* Medical history of myasthenia gravis.
* Medical history of C. difficile diarrhea.
* Organ-space infection.
* Complicated Intra-Abdominal Infection (cIAI)
* Chronic or underlying conditions at site of infection that may complicate the assessment of clinical response or would interfere with SSI healing.
* Underlying disease leading to deep immunosuppressive status.
* End-stage renal disease, CrCl \<15 mL/min.
18F-FDG PET-MRI for Planning and Follow-Up of Patients With Spine Tumors Treated With Spine Stereotactic Radiosurgery

This trial studies how well 18F-FDG PET-MRI works for treatment planning in patients with spine tumors. Diagnostic procedures, such as 18F-FDG PET-MRI may help radiation oncologists plan the best treatment for spine tumors, as well as help in follow-up after radiation therapy.

PRIMARY OBJECTIVES:

I. Determine the therapeutic efficacy of fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)-magnetic resonance imaging (MRI) in spine stereotactic radiosurgery (SSRS) treatment planning compared to advanced MRI (aMRI) and conventional MRI (cMRI).

II. Determine the diagnostic accuracy of 18F-FDG PET-MRI in follow-up of patients treated with SSRS.

SECONDARY OBJECTIVES:

I. Analysis of the subset of patients who eventually suffer local treatment failure to determine patterns of failure and potential predictive PET/MRI features at baseline.

II. Analysis of the subset of patients who suffer complications of SSRS (e.g., vertebral compression fracture) to determine potential predictive imaging features.

OUTLINE:

Patients receive fludeoxyglucose F-18 intravenously (IV) over 1 minute, and then undergo PET-MRI over 1 hour, 30 days before radiation therapy, and 3 and 6 months after radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Consent to imaging study
* Presence of at least 1 lumbar vertebral body bone metastasis \> 1 cm in shortest diameter and smaller than 75% of the vertebral body cross sectional area. Metastasis may be determined by pathology, or imaging appearance.
* Eligibility to receive SSRS (determined by treating radiation oncologists)
* Plan for single-fraction SSRS
* Standard-of-care spine MRI within 8 weeks of radiation therapy
* Ability to understand and willingness to sign a written informed consent document
* Non-English speaking participants will be included. Verbal Translation Preparative Sheet (VTPS) short form will be utilized in consenting non-English speaking participants.

Exclusion Criteria:

* Absolute or relative contra-indication to MRI, including presence of a pacemaker that requires involvement of cardiology/anesthesiology during the scan
* Prior directed radiation to the involved segment
* Contra-indication to gadolinium based contrast agents (e.g., allergy, pregnancy)
* Individuals younger than 18 years
* Hardware at the treatment level or hardware affecting visualization of the involved level on MRI
* Pregnant women
Impact of Rapid Detection of MRSA

The objective of this study is to evaluate the impact of the Alere\&#8482; PBP2a test combined with pharmacist review of antimicrobial therapy, on clinical outcomes and cost in hospitalized patients with sterile site S. aureus infection.


Eligibility Criteria:
Inclusion criteria:

1. Inpatients (adults and children) at Mayo Clinic, Rochester with sterile source S. aureus cultures (both control and intervention periods)
2. Above, with rapid PBP2a testing (intervention period only).

Exclusion criteria:

1. Patients with polymicrobial cultures (i.e., growth of S. aureus plus other organisms in the culture).
2. Patients who have not provided MN authorization to use their medical records for research.
3. Patients who have had the FilmArray Blood culture identification diagnostic test performed on an index S. aureus blood culture.
4. Patients who have had a sterile source S. aureus culture within the prior 30 days.
Esophageal Dysmotility - Prospective Study Evaluating Methods for Esophageal Dilation

The purpose of the study is to prospectively evaluate the most effective treatment of esophageal dysmotility that alleviates symptoms of dysphagia and improves quality of life.

Current practice uses either semi-rigid Savary dilators or balloon dilators for esophageal dilation to treat dysphagia due to esophageal dysmotility. The study aims to show which treatment method is more effective in alleviating symptoms, since there are no other treatments available. The null hypothesis is that there is no difference between the clinical benefits of each treatment.

Both the Savary and balloon dilators are used as routine procedure at University of Massachusetts (UMass) Medical School's academic medical center UMass Memorial Health Care (UMMHC). Gastroenterologists are required as part of their training to be familiar with both types of procedures. This study aims to definitively determine which treatment method is more effective in alleviating the symptoms of esophageal dysmotility.

The primary clinical endpoint is to assess the therapeutic efficacy of different types of dilators in an esophageal dilation procedure in patients with esophageal dysmotility. This will be evaluated through the use of the dysphagia scale (Knyrim et al, 1993). The secondary aims are to assess time to relapse, diet improvement, as well as change in quality of life. Investigators will determine time to relapse by time between the dilation procedures. Participants are instructed to contact the GI office to schedule another dilation if they feel as though the therapeutic effect of the procedure has subsided and they are in need of additional relief. Diet will be assessed using the diet score (Cox et al, 1998) and quality of life will be assessed using the Short Form (SF) SF-12 Health Survey.

If patients fail the first procedure, they can be offered the alternative procedure at a later date. Both the patient and physician must agree that the treatment has not worked, and then the patient will be given the opportunity to cross over to the other procedure, still blinded to the device that will be used. Investigators will conduct an interim evaluation to assess the progress of the study and degree of crossover. This will ensure that all subjects are given the opportunity to have both devices used in the event that one is significantly superior to the other.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Dysphagia to liquids and/or solids
* Diagnosis of esophageal dysmotility
* Normal endoscopic exam

Exclusion Criteria:

* Diagnosis of achalasia
* Defined strictures or webs
* Vulnerable populations:
* Adults unable to consent (Individuals who are not yet adults (infants, children, teenagers), Pregnant women, Prisoners)
Evaluation of the VEGA Knee System® Range of Motion

The primary objective of this study is to evaluate the function of the knee after a total knee replacement with the VEGA system®.

To evaluate patients after total knee arthroplasty in terms of function for five years.

Eligibility Criteria:
Inclusion Criteria:

* willing to sign the informed consent.
* Patient has intact collateral ligaments.

Exclusion Criteria:

* Inflammatory arthritis
* Patients that have had a high tibial osteotomy or femoral osteotomy
* Patients with neuromuscular or neurosensory deficiency which would make it difficult to assess the device performance.
Multifactorial Intervention on Cardiovascular Risk Factors in Subjects With Peripheral Arterial Disease

The purpose of this study was to evaluate whether an intensified multifactorial intervention program about cardiovascular risk factors in subjects with peripheral arterial disease (with and without diabetes mellitus), can improve the control of these factors (mainly hypercholesterolemia and hypertension) in relation to the habitual care

Subjects with peripheral arterial disease show an increased cardiovascular risk. It is thought that improving control of cardiovascular risk factors (hypercholesterolemia, hypertension, diabetes, smoking) could be beneficial in reducing their cardiovascular risk. However, usual care of these subjects (mainly at primary care) is not associated with an optimal control of such cardiovascular risk factors. We hypothesise that an intensive multifactorial treatment in a Cardiovascular Risk Unit could improve control of these cardiovascular risk factors. To test this hypothesis we perform a controlled, randomized, open, parallel trial. Subjects are recruited at the Vascular Surgery Unit and are randomised into two groups: 1. usual care (control group); 2. intensive care (intervention group). Randomization is stratified for the presence/absence of diabetes mellitus and with the use of sealed envelopes. Patients assigned to receive usual care (general practitioner with the possibility of being referred to specialists) are compared to those assigned to undergo intensive multifactorial intervention. This intervention involves strict treatment goals (LDL-cholesterol \< 100 mg/dl, blood pressure \< 130/80, HbA1c \< 7 %, no smoking) to be achieved through behavior modification (diet, physical activity, smoking cessation) and a stepwise introduction of pharmacologic therapy for hypercholesterolemia, hypertension and diabetes. This multifactorial intervention is overseen by a multidisciplinary team (endocrinologist, nurse, and dietitian) at the Hospital of Sabadell (Corporación Parc Taulí). The treatment goals are the same for the usual care group and general practitioners caring patients included in this study are informed of these strict treatment goals. Patients in the intensive-therapy receive 6 scheduled individual consultations in one year (baseline and 2,4, 6 and 9 months after their inclusion).Primary and secondary outcomes are evaluated at 12 months after their inclusion.

Eligibility Criteria:
Inclusion Criteria:

* Arm-ankle index \< 0.85 and \> 0.40 in at least one leg

Exclusion Criteria:

* Advanced peripheral arterial disease (arm-ankle index \< 0.40 or amputation)
* Peripheral arterial disease of non-atherosclerotic origin (e.g. vasculitis)
* Heart failure (NYHA III or IV)
* End-stage renal disease
* Atrial fibrillation
* Active peptic ulcer disease
* Blood coagulation disorders
* Platelets disorders
* Cancer
* History of rhabdomyolysis
* Treatment with immunosuppressant agents (e.g. cyclosporine, glucocorticoids)
* Excessive intake of alcohol (\> 280 gr/week)
* Institutionalized patients
Phase II Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents

The purpose of this study is to determine whether the combination of Temozolomide and Cisplatinum is effective in the treatment of malignant glial tumours of children and adolescents


Eligibility Criteria:
Inclusion Criteria:

* Age from 4th birthday and younger than 21st birthday
* Histologically documented malignant glial tumour (WHO classification grade III and IV) : astrocytoma, oligodendroglioma, oligoastrocytoma and mixed tumours
* Measurable and evaluable disease by the imaging criteria (MRI)
* Patient not previously treated by either of the two drugs

Exclusion Criteria:

* Malignant brain stem tumours are excluded
Metabolomics Profiling Research of Human Cerebrospinal Fluid in Aging Process

Perform quantitative metabolomics on human cerebrospinal fluid (CSF) samples and establish the first human CSF Metabolome Database of aging process in Taiwan.

Metabolomics is new science based on metabolite profiles in biofluids and tissues, which under bioinformatics approaches and analyses could help to characterize metabolomic status of CSF in aging process. In this prospective study, the investigators plan to enroll 200 health volunteers and 40 neurodegenerative diseases patients with received operation under spinal anesthesia. Blood and CSF samples will be analyzed using hydrogen-1 nuclear magnetic resonance (1H-NMR) and lipid chromatography-mass spectrometry (LC-MS).

Eligibility Criteria:
Inclusion Criteria:

Aging groups:

1. . Above 20 years.
2. . No history of central nerve system injury and neurologic illness
3. . ASA≦II
4. . Written informed consent from the patient

Aged-related neurodegenerative diseases group:

1. . Above 60 years of age
2. . Medical record proved the history of Parkinsonism or Alzheimer disease
3. . ASA≦III
4. . Written informed consent from the patient or guardian by statute.

Exclusion Criteria:

1. patient refuses to sign informed consent
2. patients with coagulopathy, systemic infective disease and severe liver and renal function impairment
3. patients with spine or brain tumor and CNS disease
4. the presence of severe and/or uncontrolled and/or unstable medical disease within 12 months prior to study (e.g. acute pancreatitis, stroke, liver cirrhosis, congestive heart failure, and systemic immune disorder etc
5. Concurrent participation or planning to participate in another interventional clinical trial (Concurrent participation in an observational trial allowed)
Stricture Definition and Treatment (STRIDENT) Observational Study.

Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. The STRIDENT (stricture definition and treatment) studies aim to determine biochemical and imaging features associated with the development of strictures and in related STRIDENT studies develop strategies for treatment.

Patients with asymptomatic Crohn's disease strictures will be followed prospectively for 12 months using imaging (including MRI/intestinal ultrasound) and biochemical analyses (including CRP/calprotectin). Patient's with symptomatic or asymptomatic ulcerative colitis related strictures will be followed similarly. Risk factors for progression of strictures and development of symptoms will be identified.

Eligibility Criteria:
Inclusion Criteria:

* Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy but without associated symptoms

Exclusion Criteria:

* Low rectal or anal strictures
* Evidence of dysplasia or malignancy from stricture biopsies or adjacent mucosal biopsies
* Patients for whom endoscopy is not suitable due to co-morbidities or clinical state
* Inability to give informed consent
* Suspected perforation of the gastrointestinal tract
* Inability to undergo MRI small bowel due to a contraindication.
A Research Study Investigating NNC0247-0829 for Weight Management in People With Overweight or Obesity

This study looks at NNC0247-0829 (a potential new medicine) for weight management in people with overweight or obesity. The study looks at how NNC0247-0829 works in the body. Participants will either get NNC0247-0829 or placebo (a 'dummy' medicine) - which treatment is decided by chance. NNC0247-0829 is an experimental medicine which has not been approved by the US FDA. Participants will get either 1 injection or a total of 4 injections (one week apart) by a study nurse at the clinic depending on what group they are in. The study will last for about 18 months, but participation will last from 11 to 23 weeks. This will depend on the group participants are in. Participants will attend 8 to 14 visits at the clinic with the study staff. Some participants will have one 16-day, 15-night visit and one 2-day, 1-night visit. Others will have two 2-day, 1-night visits. At all visits except one, participants will have blood tests and other checks. They will be asked about their health, medical history and habits including mental health questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Female not of childbearing potential (CBP) or male, aged 18-60 years (both inclusive) at the time of signing informed consent.
* Body mass index (BMI) between 27.0 and 34.9 kg/m\^2 (both inclusive) in the SD cohorts and between 27.0 and 39.9 kg/m\^2 (both inclusive) in the MD cohorts at screening. Overweight or obesity should be due to excess adipose tissue, as judged by the investigator.

Exclusion Criteria:

* Male subject who is not surgically sterilised (vasectomised) and is sexually active with female partner of childbearing potential in the absence of highly effective contraception.
* Any disorder, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
* Use of prescription or non-prescription products, including herbal products and non-routine vitamins, within 14 days prior to screening. Mild painkillers are permitted until 24h prior to screening.
Improving Vocational Outcomes in Arthritis

The long-term objectives of this research project are to enhance program participation and improve the employment prospects of people with work disability due to arthritis and related musculoskeletal disorders (ARMD) who are actively seeking vocational (job-related) rehabilitation (VR) services.

This study is designed to compare the employment situations of a group of people receiving a two-part intervention and a group that is not receiving the intervention. The intervention consists of training sessions to help prospective VR clients with ARMD successfully enter and complete the VR program, and training sessions for a randomly selected group of VR professionals to help them serve VR clients with ARMD more effectively.

The long-term objectives of this research project are to enhance program participation and improve the vocational outcomes of people with work disability due to arthritis and related musculoskeletal disorders (ARMD) who are actively seeking vocational rehabilitation services.

Some researchers think that people with work disability due to ARMD seeking vocational rehabilitation (VR) services who are exposed to an "agency access intervention" are more likely to gain entrance to the VR system and be determined eligible for services than are similar people not exposed to the intervention. Further, they think that people with work disability due to ARMD who are determined to be eligible for VR services, and who are exposed to an "agency enhancement intervention" while receiving services, are more likely to become and remain employed upon completion of the VR program than are similar people not exposed to the intervention.

The research design is a randomized, controlled, field experiment comparing the vocational outcomes of a group receiving a two-part intervention to those not receiving the intervention. The design allows us to evaluate separately each component of the intervention. The intervention consists of training sessions to help prospective VR clients with ARMD successfully enter and complete the VR program, and training sessions for a randomly selected group of VR professionals to help them serve VR clients with ARMD more effectively.

If this intervention strategy can significantly increase (1) VR utilization rates; (2) post-service employment rates; and (3) length of post-service employment in a previously underserved group with historically poor VR outcomes, it could have a significant role in reducing the immense impact, nationally, of work disability due to ARMD.

Eligibility Criteria:
Inclusion Criteria:

* Resident of Alabama
* Previously employed
* Currently unemployed due to musculoskeletal disability
* Feel capable of work
* Want to work

Exclusion Criteria:

* Not a resident of Alabama
* Unable to work
Walking or High Intensity Exercise for Anxiety

After an initial phone screen process, approximately 50 participants will be enrolled and evaluated/screened in person after consenting to achieve 30 eligible participants with a principal diagnosis of GAD, panic disorder, or social anxiety disorder and high anxiety sensitivity (Anxiety Sensitivity Index score =20). Participants will be given a choice of either high intensity interval training (HIIT) or walking interventions, which will be completed over the course of 8 weeks. The goal of the study is to 1) obtain pilot data comparing the efficacy of HIIT vs. walking for effects on psychiatric, functioning and immune outcomes, 2) to identify adherence levels given the choice of exercise intensity, and 3) to identify proportion of individuals opting for each intervention. Results from this pilot study will be used to inform future grant applications including a K award.


Eligibility Criteria:
Inclusion Criteria:

* Anxiety Sensitivity Index score of ≥20 (i.e., high anxiety sensitivity)
* Primary psychiatric diagnosis of generalized anxiety disorder (GAD), social anxiety disorder, or panic disorder
* Currently sedentary (≤60 minutes of moderate intensity exercise per week for the past 3 months)
* Able and willing to provide informed consent

Exclusion Criteria:

* Lifetime history of Bipolar I or II or any psychotic disorder
* Meets criteria for bulimia or anorexia in the past 6 months
* Meets criteria for substance use disorder in the past 3 months
* High current suicide risk as indicated by a score of ≥4 on the C-SSRS
* Risk for exercise according to Physical Activity Readiness Questionnaire with excluded medical conditions including heart conditions, lung disease, bone/joint problems, or seizures
* Women who are currently pregnant or plan to become pregnant during the duration of the study
* Participation in concurrent evidence-based therapy (e.g., cognitive behavioral therapy) targeting anxiety or depression (supportive therapy and couples therapy are allowed)
* Participants on psychiatric medication must be on a stable dose for ≥8 weeks prior to participation
* Current substance abuse or positive urine toxic screen (recreational use of marijuana is permitted based on clinical assessment on the MINI that it does not meet criteria for cannabis use disorder)