cyrilzakka/clinical-trials huggingface dataset:
Daptomycin > 6 mg/kg/Day as Salvage Therapy in Patients With Complex Bone and Joint Infection: Cohort Study in a Regionalreference Center

The choice of antimicrobial therapy to treat complex bone and joint infections (BJI) is challenging, requiring consideration of: (i) the problem of bone diffusion; (ii) the necessity of using antimicrobials active against bacterial biofilms; (iii) the growing incidence of antibiotic resistance; and (iv) the high risk of severe adverse events (SAE) in response to first-line antimicrobials in these patients.

Consequently, off-label use of recently developed antimicrobials, such as daptomycin, is frequently required as salvage therapy in complex BJI. Even if daptomycin does not have approval for the treatment of BJI, the Infectious Diseases Society of America guidelines propose this antibiotic as alternative therapy for prosthetic joint infection. The recommended dose is 6 mg/kg/d, whereas recent data support the use of higher doses in these patients as bone penetration of daptomycin is limited.

The present cohort study aimed to assess the safety and efficacy of prolonged high-dose (\>6 mg/kg/d) daptomycin salvage therapy in patients with complex BJI.


Eligibility Criteria:
Inclusion Criteria:

* patients having BJI treated by daptomycin at \>6 mg/kg/d

Exclusion Criteria:

-
Survival Rate of Lithium Disilicate Crowns

A retrospective clinical study will be performed evaluating a large number of partial ceramic restorations (IPS e-Max press, Ivoclar, Liechtenstein) placed in general practice. Evaluation will be based on the well established Hickel criteria (Hickel et al, 2010). Rationale: IPS-e-max press has been made available to the market since 2006. Although millions of these restorations have been placed worldwide, clinical data are available of less than 200 single restorations only, covering observation periods of 2-8 years.(Guess et al, 2009; Etman en Woolford, 2010; Gehrt et al, 2012; Esquivel-Upshaw et al, 2012).

Objective: Study the survival of lithium disilicate restorations during regular check-ups in a private dental practice.

Study the survival of lithium disilicate restorations during regular check-ups in a private dental practice. All included patients were followed-up with special emphasis on the partial restoration(s), every time they visited the dental practice for regular dental check-ups between 2015 and 2017. To assess these restorations a light photograph with a digital camera (Nikon (D7100, 60mm lens), Nikon, Amsterdam, The Netherlands) and an x-ray were taken from the partial posterior crowns and evaluated according to the modified United States Public Health Service (USPHS) criteria.

Eligibility Criteria:
Inclusion Criteria:

* In order to be eligible to participate in this study, a patient must received one or more lithium disilicate restorations between 2006 and today.

Exclusion Criteria:

* No patients will be excluded from the study.
Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Hyperglycemia

This study was conducted to investigate the effects of daily supplementation of Angelica gigas N. extract on improvement of Hyperglycemia .

This study was a 8 weeks, randomized, double-blind, placebo-controlled 2×2 cross-over design human trial. Twenty subjects were randomly divided into Angelica gigas N. extract or a placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were assessed before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-80 years with fasting glucose 100-125 mg/dL or 2 hour postprandial glucose 140-199 mg/dl

Exclusion Criteria:

* Weight less than 48 kg or weight decreased by more than 10% within past 3 months
* Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 6 months or Blood sugar, Obesity and Lipid improvement functional foods within past 2 weeks
* Treated with corticosteroid within past 4 weeks
* Severe cardiovascular disease(Mvocardial infarction, Stroke, etc)
* Renal disease(Heredity hyperlipidemia, Acute/Chronic renal failure, Nephrotic syndrome, etc)
* Rheumatoid arthritis, Autoimmune disease
* Cancer, Respiratory organ disease(Asthma, Chronic obstructive pulmonary disease)
* Allergic or hypersensitive to any of the ingredients in the test products
* History of disease that could interfere with the test products or impede their absorption
* Under antipsychotic drugs therapy within past 2 months
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test by show the following results

  * aspartate aminotransferase, alanine aminotransferase \> Reference range upper limit treble
  * Serum Creatinine \> 2.0 mg/dl
* Pregnancy or breast feeding
* Not Contraception(except: Surgery for female infertility)
Interest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders

The study use a new ecological questionnaire called ESSME developed by a care team in order to evaluate ecological environment of patients with schizophrenia-like disorders.

Indeed, evaluation in an ecological environment would make it possible to be as close as possible to the concerns of theses patients, which could improve the care of this population, by making it possible to set with the patient objectives anchored in their daily life.

The duration of patient's participation to the study is 6 months plus 7 to 14 days.

The study includes the following visits :

* V0: Inclusion visit (Day 0) with the administration of standard of care questionnaires;
* V1: visit at patient's home (Day 0 +7 to 14 days) with the administration of the experimental ESSME questionnaire;
* V2: follow-up visit at 6 months (M6) with the administration of the same standard of care questionnaires than at the inclusion visit;
* V3: visit at patient's home (M6 + 7 to 14 days) with the administration of the experimental ESSME questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* man or woman aged 18 to 65 inclusive;
* diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders version number 5 (DSM-V) criteria;
* patient receiving care in a Center for Rehabilitation and Intersectoral Therapeutic Activities (CREATIV);
* person who consented to the study;
* affiliate or beneficiary of a social security scheme.

Exclusion Criteria:

* patient aged under 18 or over 65;
* pregnant or breastfeeding women;
* person unable or unwilling to receive a home visit;
* person not consenting to the study;
* presence of a diagnosis of an associated neurodevelopmental disorder;
* presence of a diagnosis of dementia or associated neurodegenerative process;
* person with a level of French language insufficient to understand the items.
LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm

The cohort registry is both retrospective and prospective, multicenter surveillance of subjects who underwent a prior hiatal hernia repair and Magnetic Sphincter Augmentation or fundoplication construction more than 2 years prior to initial study visit.

The cohort registry is both retrospective and prospective, multicenter surveillance of subjects who underwent a prior hiatal hernia repair and anti-reflux surgery with either Magnetic Sphincter Augmentation (MSA) using LINX placement or fundoplication construction more than 2 years prior to initial study visit. Subjects will be enrolled by invitation only by participating investigators. Enrollment will consist of 300 LINX MSA patients and 150 fundoplication patients with a total of 450 from 4 sites within the United States. Data will be collected for up to 6 years.The primary objective of this study is to determine the long-term incidence of hiatal hernia recurrence in patients who undergo hiatal hernia repair of a large (\>3 cm) hernia with LINX® device placement, and to compare this with hiatal hernia recurrence rates in patients who underwent hiatal hernia repair with fundoplication.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be at least 21 years of age and at least the minimum Age of Majority according to applicable state law.
2. Underwent primary index procedure of laparoscopic repair of a hiatal hernia larger than 3 cm with placement of a LINX® device or construction of a fundoplication for reflux control more than 2 years prior to his/her enrollment or has completed 1 or 2 of the barium swallows and GERD-HRQLs within study time points with or without hiatal hernia recurrence.
3. Subject is willing and able to cooperate with follow-up examinations.
4. Subject has been informed of the study procedures and treatment and has signed an informed consent.

Exclusion Criteria:

1. The surgical procedure was completed as an emergency procedure
2. Currently being treated with another investigational drug or investigational device
3. Suspected or confirmed esophageal or gastric cancer
4. Subject has Barrett's esophagus \>3cm
5. Cannot understand trial requirements or is unable to comply with follow-up schedule
6. Pregnant or plans to become pregnant during the course of the study
7. Medical illness (i.e. congestive heart failure) that may cause the subject to be non-compliant with or able to meet the protocol requirements or is associated with limited life expectancy (i.e. less than 3 years)
8. Diagnosed psychiatric disorder (e.g. bipolar, schizophrenia, etc.), subjects that exhibit depression that are on appropriate medication(s) are allowable.
Effectiveness of Adaptive Servoventilation (ASV) in Patients With Central Sleep Apnea Due to Chronic Opioid Use

Prospective, randomized, blinded, cross-over study assessing the effectiveness of adaptive servo-ventilation (ASV) in treating patients who have obstructive sleep apnea (OSA) complicated by central sleep apnea (CSA) due to the chronic use of opioid medications

The trial seeks to determine the efficacy and patient comfort of ASV and bi-level positive airway pressure (PAP) modes for the treatment of obstructive sleep apnea (OSA), complicated by CSA secondary to opioid use. Subjects will be randomized to one of two groups, utilizing a cross-over design to evaluate the two modes with the subject as their own control.

Subjects will be asked to undergo two PSG studies; one with ASV titration and one with bi-level treatment, using the current pressure prescription. The study comprises two visits. Subjects will be asked to complete patient satisfaction questionnaires following their PSG studies. It is anticipated that total subject participation will be no longer than one month.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Taking opioid medications for at least 6 months. Opioid medications include but are not limited to: oxycodone, fentanyl, methadone, levorphanol, hydromorphone, and morphine
* Using bi-level PAP for at least 30 days

Exclusion Criteria:

* Primary heart or lung disease, for example: chronic obstructive pulmonary disease, pulmonary fibrosis, severe heart failure, uncorrected congenital heart disease, pulmonary hypertension
* Primary neurologic disease, for example: neuromuscular disease, previous stroke or cognitive impairment
* Narcolepsy
* Acute upper respiratory tract infection
* Pregnant
Virtual Reality in the Rehabilitation in Patients With Lower Limb Amputation.

The goal of this clinical trial is to test the impact of virtual reality on rehabilitation for the patients after a major amputation.

The main questions it aims to answer are:

* Does the virtual-reality-assisted rehabilitation improve the life quality of patients (i.e. lesser pain, better spirit)?
* Does the virtual-reality-assisted rehabilitation improve the daily life function of the patients? Participants will received a virtual-reality-assisted rehabilitation on the second postoperative day for ten days. The rehabilitation would be carried out two times per day and 30 minutes per training.

Despite the increasing development of revascularisation techniques, lower limb amputation often represent the last chance of survival for the vasculopathic patient with chronic limb threatening ischemia (CLTI). First goal after lower limb amputation is represented by a rapid prosthesis application. The patient in the immediate post-operative period must undergo intensive rehabilitation and physiotherapy, which involves not only a physical but also a psychological approach.

"Classical" recovery following lower limb amputation includes adequate pain therapy and physiotherapy to regain independence, strength, mobility and finally prothesis application to improve quality of life and restore mobility. The aim of this study is to investigate the effect of adding virtual reality to traditional rehabilitation following a lower limb amputation in patients due to limited circulation, with particularly attention to a possible improvement of psychological state, reduction of post-operative pain and more rapid improvement in regaining functional mobility

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* critical limb ischemia or acute limb ischemia
* amputation above/below knee
* unilateral lower limb amputees

Exclusion Criteria:

* physical disability (paralysis, plegia)
* inability to give informed consent
* neurological or psychiatric problem that reduces compliance
* loss of planned post-operative assessments
* traumatic amputation in a patient without circulatory disorders
A Danish ICD-study in Patients with Coronary Artery Disease Resuscitated from Ventricular Fibrillation

DanICD is a randomized, controlled study to with the aim to assess whether there is a benefit of ICD-implantation in patients with coronary artery disease (including acute myocardial infarction), who survive cardiac arrest due to ventricular fibrillation/sustained ventricular tachycardia and undergo revascularization and with an LVEF above 35%.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CAD and cardiac arrest due to VF/VT, where angiogram is performed with complete revascularization (PCI, CABG or hybrid coronary revascularization) before ICD implantation. Unfavorable artery for PCI (i.e., excessive vessel tortuosity or chronic total occlusion) or high-risk invasive treatment is not mandatory in order to achive complete revascularization.
* Age ≥18 years
* LVEF \>35% at the time of discharge. The most recent LVEF assessment on which the current medical treatment will be based at the time of entry into the study will be used as baseline LVEF.

Exclusion Criteria:

* Non-ischemic cause of cardiac arrest (i.e. ion channel diseases, non-ischemic cardiomyopathy)
* Previous CABG within the last 3 months before index hospitalization
* Life expectancy less than 1 year or severe neurologic outcome
* Unable or unwilling to give informed consent
* Pregnancy
Kidney AI-enabled Care Transformation

In the Kidney ACTion study, CKD (Chronic Kidney Disease) patients at increased risk of progression to ESRD (End Stage Renal Disease) will be randomly assigned to either standard of care in a specialist nephrology outpatient clinic or to receiving CKD care supported by a novel AI-supported (Artificial Intelligence) software solution.

The Advancing American Kidney Health (AAKH) initiative has the goal of an ambitious 25% reduction of ESRD incidence by 2030. There is a lack of successful integrated care programs to reach this goal. The CKD population is very heterogeneous, this explains the different risk of progression to ESRD in different patients. However, Guidelines (GLs) for the treatment of CKD patients address risk factors identified in the CKD population at large. Thus, all CKD patients at the same stage receive similar treatments no matter the specific risk of developing ESRD. Up to 5.9% of Europeans have CKD stages 3-5. Treating this huge number of patients would strain health systems from both the organizational and economical point of view. It is reasonable to think that dedicating a personalized management specifically to CKD patients at high risk of progression would be cost-effective.

GLs include behavioral (e.g. lifestyle, nutrition) as well as medical (e.g. drug therapy) interventions. Although patient's engagement and empowerment play a pivotal role in successful disease treatment, there is lack of evidence on practices to foster them in CKD patients.

Kidney ACTion is a program that supports nephrologists in predicting disease progression for CKD patients and developing multidisciplinary, personalized, evidence-based treatment and care plans. Patient engagement and empowerment is a fundamental part of the program.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥18 years at the time of signing the informed consent
* Chronic kidney disease with eGFR \<45 mL/min/1.73 m2 and UACR \>300 mg/g creatinine (eGFR=estimated glomerular filtration rate; UACR=Urine Albumin-to-Creatinine Ratio)
* Patient is willing to comply with the study requirements for therapy during the entire study period
* Patient is capable of providing written informed consent to participate in the study

Exclusion Criteria:

* Patients with underlying renal disease likely to receive disease-specific therapy other than SoC (Standard of Care)
* Patient expected to require renal replacement therapy within less than one year from study inclusion
Study to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis

This is a phase 1b multiple ascending dose escalation study to evaluate the safety and tolerability of arginase inhibitor CB-280 in subjects with cystic fibrosis.

Study CX-280-202 is a Phase 1b, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of CB-280 in adult subjects with cystic fibrosis and chronic infection with Pseudomonas aeruginosa. The study will evaluate the safety, pharmacokinetics, pharmacodynamics, and biological activity of CB-280 in approximately 32 adult patients with cystic fibrosis. There are four planned sequential dose escalation cohorts of 8 subjects each, randomized 6:2 to receive CB-280 or matched placebo at doses of 50 mg, 100 mg, 200 mg, or 400 mg administered twice daily for 14 days. Intermediate dose levels may be evaluated based on emerging safety data at the planned dose levels.

Eligibility Criteria:
Inclusion Criteria:

1. Written Informed Consent in accordance with federal, local, and institutional guidelines
2. Confirmed diagnosis of cystic fibrosis
3. Male or female subjects ≥ 18 years on the date of informed consent
4. Percent predicted FEV1 of 40-90% at screening per Global Lung Function Initiative (GLI) equation
5. Clinically stable with no significant changes in health status within 28 days prior to Day 1
6. Chronic lung infection with P. aeruginosa defined as at least one positive culture in the last two years and more than 50% of cultures positive since then
7. Stable cystic fibrosis medication regimen for at least 28 days inclusive of CFTR modulators prior to Day 1
8. Hemoglobin \> 10 g/dL at screening
9. Glomerular filtration rate \> 50 mL/min/1.73 m2 at screening
10. Normal liver function at screening

Exclusion Criteria:

1. History of any comorbidity that, in the opinion of the Investigator, might pose an additional risk in administering study drug to the subject or confound the results of the study
2. Lung infection with organisms associated with a more rapid decline in pulmonary status (including, but not limited to, Burkholderia cenocepacia, Burkholderia dolosa, and Mycobacterium abscessus)
3. Unable to receive study medication per os (PO)
4. Females who are pregnant, have a positive pregnancy test at screening, or are nursing (lactating)

Other protocol defined Inclusion/Exclusion criteria may apply.
Helping Ovarian Cancer Patients Cope With Their Illness (HOPE)

This clinical trial compares the effect of the Helping Ovarian Cancer Patients Cope with Their Disease (HOPE) intervention to usual care for the reduction of hopelessness and helplessness in patients with ovarian cancer that has come back after a period of improvement (recurrent). Patients with recurrent ovarian cancer are at high risk for increased death and poor mental health outcomes, including depression and anxiety. Ovarian cancer is the deadliest of all gynecologic cancers, with a survival rate at five years of only 50%. Most patients are diagnosed with advanced disease and have a high chance of recurrent disease that is incurable, even if upfront treatments are effective. Ovarian cancer's advanced diagnosis, high likelihood of recurrence and death, and rigorous treatment including surgery and other cancer therapies create high levels of distress and reduced quality of life (QOL). Patients with recurrent ovarian cancer report high rates of depression and anxiety and poor QOL. Due to the major distress, reduced QOL, and likelihood of death among this population, improving this patient population's QOL is a priority. Using the HOPE intervention may be effective in reducing hopelessness and helplessness in recurrent ovarian cancer patients.

OUTLINE:

AIM 1: Patients complete the HOPE intervention workshop virtually or in-person. The workshop consists of 3 sessions, each held once per week and lasting 60 to 90 minutes as well as complete a survey and an interview for HOPE intervention refinement during follow up.

AIM 2: Patients are randomized to 1 of 2 groups.

GROUP I: Patients complete the HOPE intervention workshop virtually or in-person, with 3 sessions held once per week, each lasting 60 to 90 minutes.

GROUP II: Patients receive usual care on study.

Patients in both groups complete baselines and follow up assessments 5, 8, and 12 weeks after the randomization event.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years of age or older
* English speaking
* Able to provide informed consent
* Current diagnosis of recurrent epithelial ovarian cancer (regardless of the amount of time since the diagnosis, given the poor prognosis of this illness with a median survival time of less than 2 years)

Exclusion Criteria:

* Patients with non-invasive gynecologic disease (i.e., dysplasia)