cyrilzakka/clinical-trials huggingface dataset:
Impact of Discontinuing Contact Precautions for Extended-spectrum β-lactamase Enterobacteriaceae in a Geriatric Unit

This is an interventional multicenter prospective noninferiority non-randomized double-blind controlled before and after study.

The aim of this study is to demonstrate that standard precautions alone are not inferior to contact precautions by comparing the incidence density of extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae acquired in geriatric units before and after discontinuing contact precautions.

Healthcare-associated infections (HAIs) are one of the main causes of morbidity and mortality worldwide. Extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae have become microorganisms frequently found in HAIs, which reduces the therapeutic possibilities.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (\> 65 years old)
* Patient hospitalized in geriatrics during the study period
* Free and informed consent obtained from the patient (or his trusted person or legal representative) within 48 hours of its admission at the geriatric unit
* Patient affiliated to a social security scheme

Non Inclusion Criteria:

* Patient requiring contact precaution for an indication other than ESBLE (COVID-19, classical PCC excluding EBLSE, Clostridium difficile PCC, scabies PCC and BHRe PCC) on admission
* Patient under legal protection
* Person deprived of liberty

Exclusion criteria:

* Patient requiring contact precaution for an indication other than ESBL during the patient stay (COVID-19, classical PCC excluding EBLSE, Clostridium difficile PCC, scabies PCC and BHRe PCC)
* Patient's stay period less than 4 days
Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir

Little is known about efficacy of switching to tenofovir monotherapy for lam-resistant chronic hepatitis B patients who achieved a complete virological response to lamivudine plus adefovir. This study was to investigate the efficacy of switching to tenofovir monotherapy for lamivudine -resistant chronic hepatitis B patients with undetectable hepatitis B virus DNA while on lamivudine plus adefovir combination therapy


Eligibility Criteria:
Inclusion Criteria:

* HBsAg (+) for \> 6 months age \>19 years antiviral resistance to LAM (rtL180M and/or M204V/I) currently receiving LAM plus ADV for more than 12 months HBV DNA levels \<20 IU/ml on two consecutive tests of 3-month interval

Exclusion Criteria:

* Cr ≥1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection with HIV, HCV
Prevention of Infections in Cardiac Surgery (PICS) Prevena Study

This vanguard study will be conducted at two study sites in Canada. It is a cluster randomized trial to test a combination of two antibiotics for antibiotic prophylaxis as compared to routine prophylaxis with one single antibiotic, and to test a negative-pressure wound management system (Prevena) versus standard wound dressing to reduce chest wound infections.

Despite the routine use of antibiotics before and after cardiac surgery, infections of the chest wound remain a common life threatening complication of heart surgery that is preventable. Antibiotic prophylaxis is well accepted to be the cornerstone of prevention for these infections. The best choice of antibiotic prophylaxis in patients undergoing open heart surgery is, however, unclear. A large number of relevant pathogens are not covered by the primarily recommended antibiotic for prophylaxis, and there is a large variability in the antibiotics physicians use in practice and a lack of evidence supporting these choices. Appropriate management of the wound is probably also highly relevant in terms of infection prevention; however, there is a lack of strong evidence guiding the choice of wound management strategies as a means to reduce surgical site infection. The proposed study will test whether dual antibiotic prophylaxis is superior to single-agent prophylaxis with cefazolin, and shed light on whether or not modern negative-pressure wound management technology lower the risk of sternal surgical site infections.

Eligibility Criteria:
Inclusion Criteria:

- ≥18 years of age undergoing open-heart surgery (sternotomy, including minimally-invasive sternotomies)

Exclusion Criteria:

* On systemic antibiotics or with an active bacterial infection at the time of surgery
* Patients previously enrolled in this trial
* Patients known to be colonized with Methicillin-resistant S. aureus (MRSA)(unethical not to administer glycopeptides), beta-lactam or vancomycin allergy precluding the use of cefazolin or vancomycin, respectively, or to silver precluding the use of Prevena
* Participation in other studies that may interfere with this trial
Impact of Acute Hospitalisation and Resistance Training on Muscle Architecture and Physical Performance in Older Adults

Sarcopenia characterised by loss of muscle mass, muscle strength and physical performance burdens many older adults since the condition is related to functional decline. Periods of inactivity such as during hospitalisation leads to further functional decline. It has been reported that the loss of muscle mass associated with sarcopenia not only entails a decrease in muscle mass but also changes in muscle architecture. Knowledge on changes in muscle architecture is essential since it is one of the most important determinants on muscle strength and thus physical performance. The main objective of this study is to investigate changes in muscle architecture and physical performance during acute hospitalisation and after discharge in older adults and subsequently the effectiveness of resistance training of the lower limb during acute hospitalisation. If successful, our study could have a great impact on the individual, as well as societal level, due to a better understanding of the factors related to sarcopenia and the prevention of functional decline as a result of hospitalisation.


Eligibility Criteria:
Inclusion Criteria:

* ≥65 years of age
* Able to ambulate before hospitalization (with/without assistance)
* Able to communicate with the research team
* Expected length of stay ≥2 days
* Residing on Funen

Exclusion Criteria:

* Able to ambulate without assistance during current hospitalization
* Known severe dementia
* Positive Confusion and Assessment Method score
* Patients who have received less than 3 resistance training sessions at discharge
* Terminal illness
* Recent major surgery or lower extremity bone fracture in the last 3 months
* Conditions contradicting use of ROBERT(unstable vertebral-, pelvic, or lower extremity fractures
* high intracranial pressure
* pressure ulcers or risk of developing pressure ulcers due to fragile skin
* patients with medical instability)
* Metastases at femur hip
* Deemed not suitable for resistance training sessions with the robot by the healthcare professional.
Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study

The objectives of this study are to evaluate the efficacy and safety of two dosing regimens of desoximetasone 0.05% and 0.25% topical sprays as compared to a vehicle spray in patients with moderate to severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Have a definite clinical diagnosis of stable plaque psoriasis involving ≥ 10% of the body surface area (BSA).
* Have a combined total lesion severity score (TLSS) of ≥ 7 for the target lesion.
* Have a plaque elevation score ≥ 3 of (moderate) for the target lesion.
* The target lesion must have an area of at least 5 cm².
* Have a Physicians Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.

Exclusion Criteria:

* Pregnancy
* Current diagnosis of other types of psoriasis other than stable plaque psoriasis or has psoriasis of any kind of the face or scalp that will require active treatment during the study.
* History of psoriasis that has been unresponsive to topical corticosteroid therapy.
* Dermatological conditions that may interfere with the clinical assessments of the signs and symptoms of psoriasis.
* Allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance which would compromise the safety of the patient or the results of the study.
* Any condition that would place the study patient at undue risk by participation in the study.
* Radiation therapy, antineoplastic agents or immunosuppressant medication within 4 weeks prior to the first dose of study drug.
* Treatment with any systemic or photo antipsoriatic therapy, within 8 weeks of the first dose of study drug.
* Treatment within 12 weeks (or five half lives, whichever is less) prior to the first dose of study drug with any biological therapies for psoriasis.
* Systemic steroids within 4 weeks of the first dose of the study drug. The use of inhaled or intranasal corticosteroids is acceptable as long as usage has been stable for at least 2 weeks prior to the first dose of study drug and will be continued during the study.
* Hormonal contraceptives for less than one complete cycle prior to entering the study.
* Topical antipsoriatic agents of any kind or any topical corticosteroids for any reason within 2 weeks prior to first use of study drug. Nonprescription antipsoriatic shampoos used only on the scalp will be allowed during the study.
* Receipt of any drug as part of a research study within 30 days prior to first dosing.
PINOT Follow-up Study in End-stage Kidney Disease

The primary aims of the Patient INformation about Options for Treatment (PINOT) Follow-up Study are to determine the proportions of patients, identified in the 2009 PINOT cohort that:

(i)Made the transition to home dialysis, after an initial start on center-based dialysis.

(ii)Commenced dialysis, or a time-limited trial of dialysis within 3 years, after confirmed plans for conservative care.

The hypotheses to be tested in the PINOT follow-up study are:

1. 50% of stage 5 chronic kidney disease patients who plan for home dialysis do not commence home dialysis within 3 years, and instead remain on centre-based haemodialysis; and,
2. less than 15% of stage 5 chronic kidney disease patients who plan for conservative care commence dialysis within 3 years.

The secondary aims of the follow-up study include:

(i) To assess the primary reasons patients did not transition to home dialysis, in the planned home dialysis group.

(ii)To compare 3 and 5 year survival rates among patients who commenced conservative care and patients who commenced renal replacement therapy.

(iii) To assess the types of dialysis utilisation over a 5 year time period among the total cohort of patients.

(iv)To determine how renal palliative care services were engaged for conservative care patients, and document the patient's place of death (i.e. hospital, hospice, home with community palliative care).

Eligibility Criteria:
Inclusion Criteria:

* Adults and children with end stage kidney disease (eGFR \<15 ml/min) who commenced renal replacement therapy or conservative care in Australia between July and September 2009

Exclusion Criteria:

* Patients returning to dialysis after a failed transplant,
* Patients with acute renal failure
Hepatitis A Virus Induced Acute Acalculous Cholecystitis Diagnosed Postoperatively: Case Report

41-year-old previously healthy patient presented with right upper quadrant abdominal pain. Pain started two days prior to presentation when an abdominal ultrasound in a peripheral hospital showed a 10 mm gallbladder stone with normal laboratory tests; however, her pain was resolved on analgesics. Now the pain was persistent and associated with vomiting and laboratory tests showed elevated bilirubin. Laparoscopic cholecystectomy with intraoperative cholangiography was done that showed inflamed gallbladder but with no stones and normal cholangiography. Day one post-operation, while the pain resolved, labs showed elevated liver function tests and hepatitis workup showed acute HAV infection attributing her presentation to HAV induced AAC.

Introduction: acute acalculous cholecystitis (AAC) is defined as gallbladder inflammation without the presence of stones. Contrary, hepatitis A virus (HAV) causes acute hepatitis A and can present with different symptoms; however, HAV causing and presenting as AAC is rare.

Case presentation: 41-year-old previously healthy patient presented with right upper quadrant abdominal pain. Pain started two days prior to presentation when an abdominal ultrasound in a peripheral hospital showed a 10 mm gallbladder stone with normal laboratory tests; however, her pain was resolved on analgesics. Now the pain was persistent and associated with vomiting and laboratory tests showed elevated bilirubin. Laparoscopic cholecystectomy with intraoperative cholangiography was done that showed inflamed gallbladder but with no stones and normal cholangiography. Day one post-operation, while the pain resolved, labs showed elevated liver function tests and hepatitis workup showed acute HAV infection attributing her presentation to HAV induced AAC.

Discussion: AAC is usually caused by stasis of the gallbladder due to different causes; however, HAV as the cause of AAC has been reported. While cholecystectomy is the mainstay treatment for AAC, this might not be the case for HAV induced AAC. For instance, unless there is necrotic gallbladder or persistence of symptoms, the AAC can be managed conservatively in this case. Even though our diagnosis was cleared post-operatively, had we know the diagnosis of HAV induced AAC before, we would still opt for surgery due to the severity and persistence of pain.

Conclusion: More cases should be reported and more studies should be done to further define the presentation and management of HAV induced AAC.

Eligibility Criteria:
Inclusion Criteria:

* acalculous cholecystitis

Exclusion Criteria:

* calculous cholecystitis
Neoadjuvant Chemotherapy of 6 Cycles vs 8 Cycles in Node Positve Breast Cancer

Various regimens and schedule as neoadjuvant chemotherapy regimens were investigated and sequential treatment of anthracyclines followed by taxanes, which has shown superior pathologic complete respone (pCR) rate (NSABP-B27 study) is widely used until now. Considering the proven efficacy and tolerable toxicity of 3 cycles of FEC followed by 3 cycles of Docetaxel (FEC3-D3) compared to FEC 6 cycles in adjuvant chemotherapy (PACS 01 trial), use of FEC3-D3 regimen in neoadjuvant setting will be feasible with acceptable efficacy and further reduce the duration of neoadjuvant chemotherapy.

To investigate feasibility of FEC3-D3 regimen in neoadjuvant setting in terms of comparable efficacy and shorter duration across all subtypes.

Eligibility Criteria:
Inclusion Criteria:

* Performance status 0 or 1
* Clinically stage 2 or 3 with histologically proven lymph node involvement
* Tumor or lymph node greater than 1.5 cm

Exclusion Criteria:

* Pregnancy or lactation
* Prior chemotherapy or radiotherapy for any malignancy
* Documented history of cardiac disease contraindicating anthracyclines
* Currently active infection
Effect of Adrenaline Concentration on Intraoperative Hemodynamics of Liposuction Patients

Liposuction is a procedure that has emerged over the last 30 years as a method to remove subcutaneous fat for cosmetic purposes. Numerous liposuction techniques have been developed .Tumescent liposuction involves using large volumes of dilute local anesthetic and epinephrine to facilitate anesthesia and decrease blood loss. Questions remain about the appropriate dose of local anesthetic, the use of general anesthesia in liposuction, and the setting in which the chosen liposuction method is used. Adrenaline is the most commonly used vasoconstrictor, the recommended concentration in the tumescent solution is 0.25-1 mg/L depending on the tissue vascularity. In the more vascular tissues, the concentration is 1 mg/L and is decreased to 0.5 mg/L in the less vascular areas of the body. The dose should not exceed 50μg/kg. If the maximum dose is anticipated to exceed, the procedure should be done in several stages.


Eligibility Criteria:
Inclusion Criteria:

* ASA I patients
* scheduled for liposuction for abdomen and flanks and body contouring with liposuction

Exclusion Criteria:

* Bleeding disorders, anemia or hemoglobin level less than 11g/dl
* Cardiovascular diseases,
* Uncontrolled diabetes mellitus,
* Collagen disorders, and
* Pregnancy
Evaluation of Volume and Electrolyte Balance in Hyponatremia Treatment - a Prospective Observational Trial

To assess quantitatively the evolution over time of electrolyte-free water clearance and electrolyte mass balance in patients with non-hypervolemic hypotonic hyponatremia

Achieving recommended treatment targets in management of hyponatremia is challenging: plasma sodium must be increased effectively but, at the same time, overcorrection has to be prevented. Yet, predictors of change of sodium over time have not been delineated properly. It was found, that evidence hinting to the fact that sodium baseline itself is crucial with respect to sodium evolution.

The goal of this study is to gather prospective data in order to precisely delineate the role of initial sodium levels by correlating those to plasma sodium evolution and electrolyte free water evolution. It is aimed to decipher patterns of sodium evolution with respect to anthropometric data, such as body composition analyses and blood pressure and markers of innate regulation mechanisms of body volume like aldosterone and renin. In addition, apart from these clinical aspects, a better appreciation of the physiological responses to hyponatremia treatment in terms of water and electrolyte balances is undoubtedly necessary to improve understanding of the body's mechanisms involved in osmotic homeostasis and cell volume control. Since studies to date also lack consideration of the intracellular department, the aim is to close that gap.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years
* Hypotonic hyponatremia

  * glucose-corrected plasma sodium \<130 mmol/l
  * serum osmolality \<280 mosmol/kg or lack of signs of non-hypotonic hyponatremia

Exclusion Criteria:

* Signs of extracellular volume expansion
* Patients with liver cirrhosis and severe liver damage AST/ALT\>3xULN, AP\>6xULN, Bilirubin ≥ 3mg/dl
* Patients with heart failure
* Patients on dialysis and/or patients with oliguric renal impairment and plasma creatinine ≥ 3mg/dl
* Patients after organ transplantation
Dynamic Annuloplasty System With Activation for the Treatment of Mitral Regurgitation

The device is a dynamic annuloplasty ring/band that is able to be adjusted in order to correct for mitral regurgitation intraoperatively or postoperatively, off-pump.


Eligibility Criteria:
Inclusion Criteria:

1. This patient requires mitral valve repair with or without concomitant procedures such as coronary artery bypass or another valve reconstruction or replacement.
2. This patient has been diagnosed with a diseased natural valve, based on echocardiography and is a candidate for mitral valve repair.
3. This patient is in satisfactory condition, based on the physical exam and investigator's experience, to be an average or better operative risk. (i.e., likely to survive one year postoperatively).
4. This patient is geographically stable and willing to return to the implant center for follow-up visits.
5. This patient has been adequately informed of his/her participation in the clinical study, and of what will be required of him/her, in order to comply with the protocol.

Exclusion Criteria:

1. This patient is less than eighteen (18) years of age.
2. This patient has a non-cardiac major or progressive disease, which in the investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than twelve months.
3. This patient has an ejection fraction \< 30%.
4. This patient has a heavily calcified annulus or leaflets.
5. This patient presents with active endocarditis or has had active endocarditis in the last 3 months.
6. This patient is pregnant (urine HCG test result positive) or lactating.
7. This patient is an intravenous drug abuser or alcohol abuser.
8. This patient has a previously implanted prosthetic mitral valve.
9. This patient requires mitral valve replacement.
10. This patient has a creatinine level \> 2.0 mg/dl
11. This patient has had congestive heart failure within the past 6 months requiring surgical treatment.
12. This patient has had a coronary artery ischemic event within the past 6 months.
13. This patient has a known life threatening, non-cardiac disease that will limit the patient's life expectancy to less than one year.
14. This patient is unable to take Coumadin.
15. This patient has a known untreatable allergy to contrast media or nickel.
16. This patient has had a cerebral vascular event within the past 6 months.
17. This patient is a prisoner (U.S.A. Only).
18. This patient is participating in concomitant research studies of investigational products.
19. This patient will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up.
Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding

The objective of this study is to assess the effectiveness of Hemospray in achieving initial hemostasis and decreased rate of re-bleeding in patients of acute variceal bleeding.


Eligibility Criteria:
Inclusion criteria :

* 18 Years and older
* Bleeding Esophageal and / or Gastric varices

Exclusion Criteria:

* Patient is: \< 18 years of age
* Unable to consent
* Contraindicated to undergo endoscopy,
* Already hospitalized for another illness
* Pregnant or lactating
* Patients with altered post-surgical anatomy of the stomach
* Previously placed intrahepatic portosystemic shunt
* Patient treated by other endoscopic or surgical modalities within 7 days prior to the intended application of Hemospray
Safety and Efficacy Study of Autologous Stem Cell Transplantation for Early Onset Type I Diabetes Mellitus

The study evaluates the effect of inactivation of the immune system with chemotherapy and immunotherapy and infusion of bone marrow stem cells in early onset type 1 diabetes mellitus. We hypothesize that reprograming the immune system will stop immune aggression to the insulin producing cells allowing their regeneration and thus decreasing or eliminating the need of exogenous insulin.

Patients from 12 to 35 years old with type I diabetes mellitus proved by anti-pancreatic beta cell antibodies and recently diagnosed (less than 6 weeks) will be included in this study. Peripheral blood hematopoietic stem cells will be mobilized from bone marrow of the patient with cyclophosphamide plus G-CSF (granulocyte-colony stimulating factor), collected by leukapheresis and cryopreserved. After 2-3 weeks, high dose immunosuppression is given (cyclophosphamide 200 mg/kg plus rabbit antithymocyte globulin 4.5 mg/kg) and stem cells are thawed and injected intravenously. This procedure is performed in isolated rooms at the Bone Marrow Transplantation Unit of the School of Medicine of Ribeirão Preto, University of São Paulo, Brazil. Patients are discharged from the hospital after engraftment and closely followed up to 2 months after transplantation (with at least weekly outpatient visits) and continue the followup for 5 years after transplantation. Clinical, hematological, metabolical and immunological evaluations are performed to analyse the effect of the transplant in the disease and in the hematopoetic and immunologic systems of the body. Patients fitting the inclusion criteria but not agreeing to perform the transplantation are the control group and they will be followed in parallel with transplanted patients.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus diagnosed by clinical/metabolic parameters and positive anti-GAD antibodies
* Less than 12 weeks from diagnosis

Exclusion Criteria:

* Previous diabetic ketoacidosis
* Pregnancy
* Severe psychiatric disorder
* Severe organic impairment (renal, hepatic, cardiac, pulmonary)
* Active infectious disease
* Previous or present neoplastic disease