cyrilzakka/clinical-trials huggingface dataset:
Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics

The purpose of this study is to determine if oral vancomycin used as primary Clostridium difficile prophylaxis can reduce the incidence of this infection in high-risk patients.

Clostridium difficile infection is a common healthcare-associated infection and one that is associated with significant morbidity as well as a risk for mortality. Current practice throughout the United States is targeted at infection prevention measures such as hand washing and isolation. Despite these measures, incidence of Clostridium difficile infections continue to rise as some institutions, including our own. Recently, a study published in Clinical Infectious Diseases found oral vancomycin for secondary prophylaxis to reduce the incidence of recurrence. No studies to date have evaluated primary prophylaxis with oral vancomycin. This will be a single center, prospective study to evaluate oral vancomycin use as primary Clostridium difficile prophylaxis. Patients treated by infectious disease physicians will be identified as "high risk" and after pager notification the ID physician will have the option to start oral vancomycin 125 mg by mouth daily if they determine it to be appropriate. Risk factors include age older than 65 years, taking gastric acid suppression medication, and receiving select broad-spectrum antibiotics. Oral vancomycin will be continued until de-escalation of antibiotics or hospital discharge and patients will be evaluated for Clostridium difficile infection development from the current hospital admission up to 4 weeks following antibiotic discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* "High-risk" patients defined as: age older than 65, on gastric acid suppression, and select antibiotics
* Gastric acid suppression includes proton pump inhibitors and histamine-2 receptor antagonists
* Selected antibiotics include fluoroquinolone (ciprofloxacin, levofloxacin), clindamycin, a 3rd or 4th generation cephalosporin, a broad-spectrum aminopenicillin (ampicillin-sulbactam, piperacillin-tazobactam), or a carbapenem

Exclusion Criteria:

* Failure to meet all three requirements for "high risk"
* Vancomycin allergy
* Active clostridium difficile infection prior to inclusion
* Prophylactic oral vancomycin prior to study inclusion (i.e. prolonged vancomycin taper)
* Receipt of medications that also treat Clostridium difficile (metronidazole, rifaximin, fidaxomicin)
* Pregnant or breastfeeding
Patients Navigators in Facilitating Weight Management in Obese Participants

This trial studies the effectiveness of patient navigators in facilitating weight management in obese participants. Health coaches or patient navigators may help more participants take part in weight management programs.

PRIMARY OBJECTIVES:

I. To evaluate the effectiveness of patient navigators to increase enrollment in evidence-based weight management programs.

SECONDARY OBJECTIVES:

I. To evaluate the effectiveness of patient navigators to increase overall attendance or use of evidence-based weight management programs.

II. To evaluate the effectiveness of patient navigators to promoting and facilitating positive health behavior change: increased physical activity; improved diet; and weight loss.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive information about commercially-available weight management programs and encouragement to participate in one of the programs for 6 months.

GROUP II: Participants receive information about commercially-available weight management programs encouragement to participate in one of the programs for 6 months. Participants also receive 6 phone calls over 20-30 minutes each from an assigned patient navigator for 6 months.

After completion of the study, participants are followed up at 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Are referred by a University of Texas (UT) health care provider
* Have a body mass index (BMI) greater than or equal to 30 and less than or equal to 45 kg/m\^2
* Are able to read and speak English
* Have a working telephone number and address where materials can be mailed
* Able to engage in moderate intensity physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q)
* Internet access at home or other location (e.g., work, church, library, community center, etc.)

Exclusion Criteria:

* Another person in the same household already enrolled in the proposed intervention
* Pregnant or thinking about becoming pregnant during the study period
* Are already involved in another weight loss program
* Participated in a weight loss, exercise, or dietary modification program in the previous 6 months
* Involuntary or voluntary weight loss of greater than or equal to 5% body weight in the previous 6 months
* Are currently using weight loss medications
Non-significant Risk (NSR) Study of [68Ga]-PSMA-11 (Illuccix) as a BgRT BioGuide on RefleXion X1

To qualitatively determine the imaging performance of PET-CT imaging subsystem of the RefleXion X1 System Device in patients undergoing standard-of-care (SOC) \[68Ga\]-PSMA-11 PET-CT using Illuccix on the same day.

In this non-significant risk (NSR) study, investigators will perform imaging only (no treatment) on the X1 platform immediately following an already planned PET/CT diagnostic imaging using Illuccix for standard of care indications in men with prostate cancer of various stages. This approach will be used to assess imaging performance of the X1 in comparison to diagnostic imaging scanners. Evidence from this study will supplement and enhance technical understanding of the PSMA-11-guided BgRT delivery in the setting of prostate cancer. As such, the patient population selected for this investigation is meant to optimally represent the spectrum of cases, with respect to motion and radiographic environment that a radiation oncologist may encounter in practice.

Eligibility Criteria:
Inclusion Criteria:

* Men with prostate adenocarcinoma undergoing standard of care PSMA-PET imaging for initial staging or re-staging at suspected relapse/progression

Exclusion Criteria:

* 1. Known psychiatric or substance abuse disorder which in the opinion of the investigator would interfere with study conduct

  2. Patient weight exceeding 450 lb (weight limit of RefleXion X1 system)

  3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
Combination Plerixafor (AMD3100)and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma

The purpose of this research study is to determine the safety of plerixafor and bortezomib, and the highest dose that can be given to people safely. Plerixafor appears to stop myeloma cells from attaching to bone marrow and has been used in other phase I studies for mobilization of stem cells for patients with myeloma and lymphoma. We have shown that the combination of plerixafor and bortezomib is very effective in killing myeloma cells in the laboratory more than the effect of each drug alone.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Must have received prior 1-5 therapies for their myeloma and have relapsed or refractory multiple myeloma. Prior therapy with bortezomib is allowed as long as they were not refractory to bortezomib
* Monoclonal protein serum of 1gm/dL or greater or monoclonal light chain in the urine protein electrophoresis of 200 mg/24 hours or greater, or measurable light chains by free light chain assay of 10 mg/dL or greater, or measurable plasmacytoma
* ECOG Performance Status 0, 1, or 2
* Laboratory values as outlined in the protocol

Exclusion Criteria:

* Uncontrolled infection
* Cytotoxic chemotherapy \< 3 weeks, or biologic or targeted novel therapy \< 2 weeks, or corticosteroids \< 2 weeks prior to registration. Patients may be receiving chronic corticosteroids if they are being given for disorders other than myeloma
* Pregnant women
* Nursing women
* Men or women of child-bearing potential who are unwilling to employ adequate contraception
* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
* Known to be HIV positive
* Radiation therapy \< 2 weeks prior to registration
Toll-like Receptor 9 Agonist Treatment in Chronic HIV-1 Infection

Combination antiretroviral treatment (cART) effectively suppresses virus replication and partially restores immune functions. However, cART cannot cure HIV infection.

This study aim to investigate whether the antiviral immune response can be enhanced and/or viral transcription reactivated with MGN1703. MGN1703 is an agonist to toll-like receptor (TLR) 9. Activation of TLR9 has been shown to augment innate and adaptive immune effector functions, most notably enhanced NK cell and T cell functions.

Furthermore, TLR9 agonists have been shown in vitro to reactivate viral transcription in latently infected cells, potentially leading to enhanced recognition of infected cells by the immune effector cells.

In Part A, participants will receive 4 weeks MGN1703 therapy (60 mg s.c. twice weekly). During the 4 weeks, participants will be closely monitored for safety and therapeutic effects of the drug. Targeted enrolment in Part A is 14-16 study subjects.

In Part B, participants will receive 24 weeks of MGN1703 therapy (60 mg s.c. twice weekly). During the 24 weeks, participants will be frequently monitored for safety and therapeutic effects of the drug. Targeted enrolment in Part B is 10-12 study subjects, preferentially recruited from part A.

Eligibility Criteria:
Inclusion Criteria:

* Documented HIV-1 infection
* Age \>18 years
* CD4+ T-cell count \>350/µL at screening
* On cART (for a minimum of 12 months)
* Able to give informed consent.

Exclusion Criteria:

* Pregnancy as determined by a positive urine beta-hCG (if female)
* Males or females who are unwilling or unable to use barrier contraception during sexual intercourse for the entire study period.
* Currently breast-feeding (if female)
* Viral load (HIV RNA) \> 50 copies/mL
* Contraindication to receive MGN1703 as per current investigator brochure
* Presence of acute bacterial infection or undiagnosed febrile condition
* Concurrent chronic systemic immune therapy or immunosuppressant medication, including continuous systemic steroid treatment within the last 2 weeks prior to randomization
* Use of antibiotic therapy within the last 2 weeks prior to randomization
* Known HBV or HCV infection
* Any medical, psychiatric, social, or occupational condition or other responsibility that, in the judgment of the Principal Investigator (PI), would interfere with the evaluation of study objectives (such as severe alcohol abuse, severe drug abuse, dementia)
* Unable to follow protocol regimen
Effect of Adaptive Servo Ventilation (ASV) on Survival and Hospital Admissions in Heart Failure

Sleep Apnea (SA) is a disorder that causes pauses in breathing during sleep that expose the heart to oxygen deprivation. It is common in patients with heart failure (HF) where it is associated with increased risk of hospitalizations and death. It is not known however whether treating SA reduces these risks. This study is looking at whether a respiratory device known as Adaptive Servo Ventilation (ASV) can reduce the rate of cardiovascular hospitalizations and death in subjects with HF and SA. Study subjects will randomly receive either their regular medications OR their regular medications plus ASV. They will be followed for approximately 5 years and information relevant to their health will be collected and compared.


Eligibility Criteria:
Inclusion Criteria:

* American Heart Association Stage B-D Heart failure due to ischemic, idiopathic or hypertensive causes, present for at least 3 months
* Left Ventricular Ejection Fraction ≤ 45 %
* Optimal medical therapy for heart failure
* No change in active cardiac medications for 2 weeks prior to randomization, beta-blockers must be started 3 months prior to randomization
* Sleep apnea with an AHI ≥ 15. Subjects with obstructive sleep apnea must also have an Epworth Sleepiness Scale score of ≤ 10 and no or mild daytime sleepiness
* Written informed consent

Exclusion Criteria:

* Heart failure due to primary valvular heart disease
* Presence of moderate to severe mitral insufficiency due to intrinsic mitral valve disease
* Hypertrophic obstructive or restrictive or post partum cardiomyopathy
* Exercise capacity limited by class IV angina pectoris
* Acute MI, cardiac surgery, PCI, AICD, or CRT within 3 months of randomization
* Active myocarditis
* Planned AICD or CRT
* Presence of a left-ventricular assist device
* Transplanted heart or expected to receive a transplanted heart within the next 6 months
* Pregnancy
* Current use of ASV or CPAP or mandibular advancement device for treatment of sleep apnea or treated with any investigational therapy during the last 4 weeks (including approved therapies being used in unapproved indications)
* A clinical history that would interfere with the objectives of this study or that would in the investigator's opinion preclude safe conclusion of the study
* Any other medical, social, or geographical factor, which would make it unlikely that the patient will comply with the study procedures (e.g. alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location, or history of non-compliance)
* Any contraindication to ASV therapy as detailed in the device provider manual
Evaluation of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Revision Arthroplasty.

The purpose of this study is to determine the efficacy of a negative pressure wound therapy (NPWT) system after revision total knee and hip arthroplasty in patients at high risk for infection. It is hypothesized that the use of NPWT system (i.e., Prevena) in high risk patients prevents wound complications and decreases reoperation rates.

One of the primary causes of un-planned readmission following lower extremity arthroplasty procedures is infection. Continuous wound drainage poses a serious risk for infection and is often initially treated with absorbent dressings and/or oral antibiotics. Comorbidities such as obesity, diabetes and tobacco abuse predisposes to wound complications and therefore infection after these procedures. NPWT has proven to be effective for postoperative drainage and decreases the risk for infection or further reoperation. This prospective randomized trial will involve 160 patients at high risk for infection undergoing revision total knee or hip arthroplasty; 80 patients will be randomly selected to be treated with the NPWT system (Prevena) and randomly selected to be treated with the current standard of care wound dressing (control group). Patients will be enrolled at a single site of the Cleveland Clinic Health System (Main Campus).

Eligibility Criteria:
Inclusion Criteria:

* Scheduled revision Total Hip or Knee Arthroplasty Procedure
* Presence of one of the following: body mass index (BMI) greater than 35, use of blood thinners other than acetylsalicylic acid (ASA) after surgery, peripheral vascular disease, depression, diabetes mellitus, current tobacco use, history of prior infection, current use of immunomodulators or steroids, current history of cancer or hematological malignancy, rheumatoid arthritis, renal failure or dialysis, malnutrition, liver disease, transplant status, or HIV.

Exclusion Criteria:

* Patient lives \>100 miles from hospital
* Patient is \< 18 years old
* Silver allergy
The Effects of Cool Dialysate on the Sleep/Wake Cycle in Patients on Chronic Hemodialysis - "The Sleep Cool Study"

A major component of this study is to test a novel application for a safe, non-pharmacologic, cost-effective intervention that is already in use in clinical practice - using cool dialysate during hemodialysis to help stabilize the sleep/wake cycle of chronic hemodialysis patients. We will also evaluate its effects on selected sleep-related physiologic, psychological, behavioral, and general health outcomes.

Preliminary results demonstrate that, after one treatment, using cool dialysate instead of warm dialysate markedly normalized the rhythm of body temperature and improved indices on nocturnal sleep quantity and quality. Therefore, a major component of this study is to test a novel application for a safe, non-pharmacologic, cost-effective intervention that is alreay in use in clinical practice - using cool dialysate during hemodialysis to help stabilize the sleep/wake cycle of chronic hemodialysis patients. We will also evaluate its effects on selected sleep-related physiologic, psychological, behavioral, and general health outcomes.

To test the efficacy of this intervention, a randomized, single-blinded, pretest-posttest, control group design is being used. The major independent variable is dialysate temperature. The major dependent variables are measures of sleep, body temperature, rest/activity patterns, and general health outcomes.

Eligibility Criteria:
Inclusion Criteria:

* All races, cause of renal failure is diabetes, hypertension, glomerulonephritis, or polycystic kidney disease; ability to read and write in English; clinically stable.

Exclusion Criteria:

* Current use of sleeping medication; history of alcoholism or drug abuse; brain disease; severe hypertension; severe heart disease; low functional level
Pharmacokinetic Study of Tranexamic Acid

Tranexamic acid is an effective anti fibrinolytic drug. Clinical studies have found that intravenous injection of tranexamic acid is more effective in reducing blood loss and transfusion in patients with advanced ovarian cancer, without increasing the risk of postoperative complications. Different surgeries and administration routes have an impact on the pharmacokinetics and pharmacodynamics of TXA. At present, there is little data on the pharmacokinetics of intramuscular injection of TXA, and almost all of the data comes from males. For ovarian cancer patients, there are currently no reports on the pharmacokinetics of TXA through different routes of administration, such as intramuscular and intravenous administration. Therefore, the investigators chose ovarian cancer patients and administered it through different routes of intravenous and intramuscular injection.

The investigators plan to recuit 30 patients, administered TXA through different routes of administration. Then Pharmacokinetic parameters of different TXA administration routes were recorded. To study the effects of different TXA administration routes on intraoperative blood loss, transfusion volume and postoperative adverse outcomes (thrombosis, etc.) in ovarian cancer patients undergoing cell reduction surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Adult women aged 20-64 diagnosed with advanced ovarian cancer undergoing cytoreductive surgery
2. The cancer stage is III-IV
3. ASA classification II-III
4. Surgical duration\>2 hours

Exclusion Criteria:

1. Renal dysfunction (serum creatinine\>200 mmol/L) or liver dysfunction (Child Turcote classification\>6)
2. Has a history of serious mental illness or disorders, epilepsy, visual impairment
3. Previous or current bleeding disorders, coagulation dysfunction, or thromboembolic events
4. Lower limb venous thrombosis
5. Anticoagulants or antifibrinolytic drugs used before surgery within the past month
6. Allergic to TXA
Trial Assessing Roux-en-Y Anastomosis of the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy

The objective is to clarify Roux-en-Y anastomosis of the pancreatic stump decreases pancreatic fistula following distal pancreatectomy, compared with stapling closure of the pancreatic stump.

The objective of this study was to clarify Roux-en-Y anastomosis of the pancreatic stump prevents pancreatic fistula after distal pancreatectomy (DP) compared to stapling closure of the pancreatic stump in a prospective randomized controlled trail.

Various methods and technique for treating surgical stump of the remnant pancreas have been reported to reduce pancreatic fistula after DP. However, appropriate surgical stump closure after DP is still controversial.

The primary endpoint in this trial was defined as the incidence of pancreatic fistula .

Eligibility Criteria:
Inclusion Criteria:

1. disease of pancreatic body and tail
2. PS (ECOG Performance Status Scale):0-1
3. Age: 20 years or older
4. distant metastases are not diagnosed preoperatively. Eligible for this clinical study when only distal pancreatectomy contributes to the favorable prognosis even if patients with pancreatic neuroendocrine cancer have the liver metastasis.
5. Adequate organ functions filled the following criteria within two weeks from enrollment:

1.White blood cell： \>3,500/mm3 or \<12,000/mm3 2.Neutrophilic leukocyte \>2,000/mm3 3.Platelet\>100,000/mm3 4.Hemoglobin \> 9.0g/dL 5.Total bilirubin \<2.0mg/dL 6.AST and ALT\<150IU/L 7.Creatinine \<1.5mg/dL 6)Patients who can provide written informed consent

Exclusion Criteria:

1. Patients with severe liver cirrhosis or active hepatitis
2. Patients with respiratory illness that requires oxygen administration
3. .Patients with chronic renal failure requiring dialysis
4. Patients with active duplicative malignant disease affecting adverse event
5. Others, patients who are unfit for the study as determined by the attending physician
A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis

This proposed study is a randomized, double-blind, placebo-controlled, 3-arm parallel, multicenter phase II study, designed to explore the efficacy and safety of SHR0302 treatment for patients with moderate to severe atopic dermatitis.

The study will be conducted over a 12-week treatment period. Two active doses of SHR0302 will be compared to placebo and improvement in atopic dermatitis will be assessed using the Investigator's Global Score (IGA)


Eligibility Criteria:
Inclusion Criteria:

* Subjects between 18-75 years of age (inclusive), male or female, at the time of informed consent
* Moderate to severe atopic dermatitis
* Capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspect of the study

Exclusion Criteria:

* Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study
* Subject has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of atopic dermatitis
* Subject has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma)