cyrilzakka/clinical-trials huggingface dataset:
Continuous Infusion of Ropivacaine Hydrochloride in Reducing Pain After Surgery in Patients With Bladder Cancer

This randomized phase IV trial studies how well the continuous infusion of ropivacaine hydrochloride works in reducing pain after surgery in patients with bladder cancer. Ropivacaine hydrochloride is an anesthetic drug used to decrease pain by numbing an area of the body without putting the patient to sleep. Continuous infusion of ropivacaine hydrochloride may reduce pain and improve the quality of life for patients after bladder surgery.

PRIMARY OBJECTIVES:

I. To determine if continuous infusion of local anesthesia (CILA) decreases post-operative pain after radical cystectomy (RC).

II. To determine if CILA reduces narcotic requirements after RC.

SECONDARY OBJECTIVES:

I. To determine if CILA decreases length-of-stay after RC. II. To determine if CILA improves patients satisfaction with post-operative pain control after RC.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive ropivacaine hydrochloride intravenously (IV) continuously over 72 hours after radical cystectomy.

ARM II: Patients receive normal saline (placebo) IV continuously over 72 hours after radical cystectomy.

After completion of study, patients are followed up within 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective open radical cystectomy
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Allergy or adverse reaction to ropivacaine (ropivacaine hydrochloride) or any amide type of local anesthesia
* Allergy or adverse reaction to local anesthesia catheter
* Additional surgery at the same time as RC (e.g. nephroureterectomy)
* Coagulopathy
* Thrombocytopenia
* Local or systemic infection
* Pregnancy
* Chronic hepatic disease
* Use of type III antiarrhythmics (e.g. amiodarone)
* History of chronic pain and/or daily opioid use
Healthier You: Optimizing Screening, Brief Interventions, and Referral to Treatment (SBIRT) in the Emergency Department

Screening, brief interventions, and referral to treatment (SBIRT) for drug use/abuse offers opportunities for early detection, brief intervention/treatment, and substance use treatment referrals for patients in medical settings. Although SBIRT components, particularly screening and brief interventions, have been shown to be effective strategies for addressing alcohol misuse in primary care, data are limited on using all of the components of SBIRT for drug-using patients, particularly in the Emergency Department (ED). Further, because of the often chaotic environment of EDs, many logistical and practical impediments exist for the adoption of the entire SBIRT model in this setting.

The proposed study will use computerized screening using touch screen computer tablets with audio (\~4,900 patients) and will test intervention strategies in a two-factorial design (3x2). Specifically, 900 patients aged 18-60 in an inner-city ED who screen positive for drug use in the past 3 months will be randomized to the combinations of three ED-based conditions (computer brief intervention-CBI; intervener brief intervention-IBI; enhanced usual care-EUC), and two follow-up conditions (adapted motivational enhancement therapy-AMET; enhanced usual care-EUC) that will take place 3 months post-ED. All individuals who meet criteria for a drug use disorder will additionally receive the "referral to treatment" or "RT" component of SBIRT. Stratified random assignment \[by gender and diagnosis of a drug use disorder (yes/no)\] will take place at baseline for all ED based and follow-up conditions. All participants will receive written information including substance abuse and other community resources, and HIV prevention materials. Recognizing that brief interventions are important, but not necessarily sufficient, for change in all patients who use drugs, the primary specific aims of the proposed study will determine the independent effectiveness of immediate "on-the-spot" ED-based brief intervention conditions, 3-month followup brief treatment conditions, and combinations of conditions, for decreasing drug use and improving health-related outcomes (including physical and mental health, and HIV risk behavior) at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* patients age 18-60 years presenting to the HMC for medical care (except exclusions as noted below)
* ability to provide informed consent. Additional inclusion criteria for intervention: past 3-month use of illicit drugs or misuse of psychoactive prescription drugs

Exclusion Criteria:

* patients who do not understand English (less than 1% in our prior work) -
* prisoners
* patients classified by medical staff as "Level 1 trauma" (e.g., unconscious, intubated on respirators, in need of immediate lifesaving procedures such as surgery)
* patients deemed unable to provide informed consent as stated above (e.g., intoxication, mental incompetence)
* patients treated in the ED for suicide attempts or sexual assault
Pattern of Cell Death Following Neoadjuvant Therapy for Metastatic Colon Cancer

Systemic chemotherapy for metastatic colon cancer is often used in the neoadjuvant setting for patients undergoing liver resection. This treatment is given either to keep the tumor at bay or reduce its size before the time of resection. While many metastatic tumors might appear to respond well and even radiographically disappear following neoadjuvant therapy, it is unclear whether grossly or radiographically negative areas of previous disease are microscopically free of tumor cells. As such, when possible, resection boarders typically follow 1 cm margins from the tumor size prior to neoadjuvant therapy. These margins might be necessary to encompass all histologically present disease or they might be unnecessarily large, serving only to increase the mortality and morbidity of the operation. This study begins to address this question by a histological examination of the pattern of cell death in areas of metastases removed after neoadjuvant therapy. Furthermore, clinical cases in which neoadjuvant therapy allowed for resection of previously unresectable cancer will be examined to determine whether there is an increased rate of recurrence despite "negative" resection boundaries in these cases.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥ 18 years old.
* Patients must have colon cancer metastases to the liver.
* Patients must be candidates and be scheduled for liver resection.
* Patients must have received and have had a response to neoadjuvant therapy prior to liver resection.
* Patients must have signed Institutional Review Board (IRB) approved written consent form prior to registering in the study.

Exclusion Criteria:

* Patients who are \< 18 years old.
* Patients who do not have colon cancer metastases to the liver.
* Patients who are not surgical candidates.
* Patients who do not schedule or who cancel a liver resection.
* Patients who have not received neoadjuvant therapy.
* Patients who have received neoadjuvant therapy but who have had no response or who have had tumor progression.
Hypofractionated Radiation Therapy Combined With Concurrent Chemotherapy for Patients With Non-small Cell Lung Cancer

The purpose of this study is to evaluate the safety of accelerated hypofractionated three-dimensional conformal radiation therapy (3 Gy/fraction) concurrent with chemotherapy for patients with unresectable stage III non-small cell lung cancer.

Increasing the biological effective dose (BED) of radiotherapy for non-small cell lung cancer (NSCLC) can increase local control rates and improve overall survival. Compared with conventional fractionated radiotherapy, accelerated hypofractionated radiotherapy can yield higher BED, shorten the total treatment time, and theoretically obtain better efficacy. However, currently, there is no optimal hypofractionated radiotherapy regimen. Based on phase I trial results, we performed this phase II trial to further evaluate the safety and preliminary efficacy of accelerated hypofractionated three-dimensional conformal radiation therapy(3-DCRT) combined with concurrent chemotherapy for patients with unresectable stage III NSCLC.

Patients with previously untreated unresectable stage III NSCLC received 3-DCRT with a total dose of 69 Gy, delivered at 3 Gy per fraction, once daily, five fractions per week, completed within 4.6 weeks. At the same time, platinum doublet chemotherapy was applied.

Eligibility Criteria:
Inclusion Criteria:

* Pathological or cytological diagnose of unresectable stage III non-small cell lung cancer
* The Karnofsky performance status (KPS) score ≥70.
* The expected survival time ≥3 months.
* Adequate blood, liver, lungs and kidney function
* Accessible contact information
* Informed consent required before enrollment.

Exclusion Criteria:

* Pregnant or breastfeeding.
* Another malignant tumor history (with the exception of patients with cervical carcinoma in situ and non-malignant melanoma skin cancer that had been clinically cured for at least 5 years)
* Cannot receive concurrent chemotherapy due to medical reasons.
* Superior vena cava syndrome.
* Severe lung diseases that affected lung function.
A Study Evaluating Gemcitabine Plus Bosutinib for Patients With Resected Pancreatic Cancer

The purpose of this study is to find out the effects, good and/or bad, of the combination of two drugs, gemcitabine and bosutinib, in patients with resected pancreatic cancer and whether this combination can prevent pancreatic cancer from coming back.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma of the pancreas.
* Complete resection by standard pancreaticoduodenectomy (for tumors of the pancreatic head) or distal pancreatectomy (for tumors of the pancreatic tail). Positive microscopic margins are allowable.
* No measurable disease.
* ECOG performance status 0 - 1.
* ≥ 18 years of age.
* Ability to start adjuvant therapy within 8 weeks after pancreatic cancer surgery (but no sooner than 3 weeks).
* CA 19-9 ≤ 2.5 times the upper limit of normal.
* ANC (absolute neutrophil count) ≥ 1500/μL
* Hemoglobin ≥ 9 gm/dL (may be transfused or may receive epoetin alfa to maintain this level)
* Platelet count ≥ 100,000/μL
* INR ≤ 1.5 (except those subjects who are receiving full-dose warfarin)
* Total bilirubin ≤ 2.0 mg/dL
* AST and ALT ≤ 2.5 times the upper limit of normal
* Serum creatinine ≤ 2.0
* Negative pregnancy test for women of childbearing potential (serum or urine beta-HCG).
* All patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
* Women or men of reproductive potential must agree to use an effective contraceptive method during treatment and for 6 months afterwards.
* At least one paraffin block from patient's pancreatic cancer surgery must be available for analysis (does not necessarily need to be received by the start of study treatment).

Exclusion Criteria:

* Any prior systemic or investigational therapy for pancreatic cancer.
* Grossly positive surgical margins.
* Any of the following post-operative complications: wound dehiscence or infection, intraabdominal abscess, pancreatic or biliary leak or fistula.
* History of major psychiatric disorder or other chronic medical illness that, in the opinion of the treating physician, contraindicates the use of the investigational drugs in this protocol or that might render the subject at high risk of treatment related complications.
* Serious active ongoing infection, including any requiring parenteral antibiotics.
* Patients with a "currently active" second malignancy other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 30% risk of relapse.
* Pregnancy (positive pregnancy test) or lactation.
* Known central nervous system disease.
* Inability to swallow pills/tolerate oral intake.
* Inability to comply with study and/or follow-up procedures.
Aortic Cross-Clamping and Systemic Inflammatory Response in Humans: Effect of Ischemic Preconditioning

Multiple organ dysfunction syndrome is a major cause of morbidity and mortality after abdominal aortic aneurysm (AAA) surgery. It is postulated that aortic cross-clamping during open AAA repair may cause ischemia-reperfusion (I/R) leading to the systemic releases of reactive oxygen species (ROS) and inflammatory cytokines which damage distant organs, including heart, kidney, and lung.

Ischemic preconditioning, first described in cardiac surgery, is a mechanism whereby tissues exposed to a brief period of nonlethal I/R develop resistance to subsequent ischemic insult. Remote ischemic preconditioning (RIPC), is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ (usually skeletal muscle) provide systemic protection from prolonged ischemia. The mechanisms through which RIPC confer organ protection remains unclear.

The hypothesis is that limb RIPC would reduce systemic inflammatory mediators produced by ischemia-reperfusion and thereby protect the remote organs.

A single-center, prospective, randomized, parallel-group controlled trial is conducted on patients undergoing elective open infrarenal AAA repair. Written informed consent is obtained from each participant. The study protocol was reviewed and approved by the Research Ethics Committee of Rouen, France.

Patients are divided in two groups : the sham-operated control group underwent surgery without RIPC and the RIPC group : Two cycles of intermittent crossclamping of the common iliac artery (right or left) with 10 minutes ischemia followed by 10 minutes reperfusion served as the RIPC stimulus, before prolonged ischemia.

Blood samples are collected for analysis at the following time points: before surgery (baseline), 1, 3 and 24 h after cross-clamp release (reperfusion). The systemic inflammatory response is measured using the serum concentrations of TNF-alpha, and IL 1, 4, 6, 10. Cardiac, renal and pulmonary functions are evaluated with usual biological markers and clinical monitoring until 28 days after surgery.

Aortic surgery is a perfect clinical model of ischemia-reperfusion which makes it possible to study the impact of RIPC in humans. This biological approach would help to better understand the mechanisms underlying this technique.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective open infrarenal abdominal aortic aneurysm repair
* Scheduled surgery
* Patients aged 30-85 years old

Exclusion Criteria:

* Patients undergoing endovascular treatment for infrarenal abdominal aortic aneurysm
* Patients younger than 30 years and older than 85 years
* pregnant women or nursing mother
* Adult under guardianship
* Refusal to sign a consent
* Patients whose survival at 28 days is unlikely
* Surgery requiring subphrenic aortic cross-clamping
* Emergency surgery
* Patients taking sulfonylureas or Nicorandil
* Patients having contraindication to clamp iliac arteries
* Dementia
Prevention of Pneumococcal Infections: Impact Collaborative Medico-pharmaceutical Care Structured to Improve Vaccination Coverage of Patients At Risk.

In France, Streptococcus pneumoniae is the leading agent bacterial involved in community lung disease and meningitis. The frequency of these infections and their mortality increase significantly in those at risk such as patients with certain chronic diseases, immunocompromised or on immunosuppressive therapy. This population, despite regular monitoring, has a limited pneumococcal vaccine coverage of around 20%. By carrying out a reconciliation of treatments upon admission to hospital, the clinical pharmacist can detect those without up to date pneumococcal vaccination status. The goal of this management is to make the patient aware of the need for vaccination and organization upon return home. Thus, this limited pneumococcal vaccination coverage would benefit from intervention by regional clinical pharmacy activities. The study investigators want to study the impact of a structured medico-pharmaceutical collaboration on pneumococcal vaccination of patients with risk on discharge from hospital. The investigators hypothesize that this collaboration in patients at risk of infection with pneumococcus could significantly increase their anti-pneumococcal vaccination coverage


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed oral consent
* The patient must be a member or beneficiary of a health insurance plan
* The patient is admitted to full hospitalization in a surgical or medical department.
* The patient will benefit from a reconciliation of drug treatments.
* The patient is considered at risk of pneumococcal infection according to the recommendations of March 2017 of the High Council of Public Health (HCSP)
* Pneumococcal vaccination is not up to date according to the HCSP 2017 recommendations.

Exclusion Criteria:

* The subject is participating in a category 1 interventional study
* The patient has participated in a category 1 trial within the previous 3 months or is in a period of exclusion determined by a previous study
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is not in a fit state to express consent
* The patient is pregnant, parturient or breast feeding
VITROS Immunodiagnostic Products NT-proBNP II

Amino Terminal pro-Brain Natriuretic Peptide (NTproBNP) is secreted in conditions of cardiac wall stress. NTproBNP levels are used in addition to clinical assessment to diagnose heart failure (HF). The purpose of this clinical study is to collect data to substantiate the use of the VITROS NT-proBNP II assay.

A prospective clinical sample collection and NT-proBNP testing will be conducted in two populations. Patients presenting to the Emergency Department (ED) and patients presenting to outpatient centers will be approached for enrollment.

Clinical and laboratory data will be collected to demonstrate product performance compared to adjudicated clinical diagnosis. Approximately 4300 evaluable subjects at geographically dispersed sites in the US will be enrolled in the study.

Sample collection and testing of clinical samples with the VITROS NT-proBNP II assay will be performed under two separate protocols.

Eligibility Criteria:
Acute HF Population (ED setting):

Inclusion Criteria:

* Subjects must have suspicion of HF and acute symptoms at presentation.
* Subjects must be at least 22 years of age.
* Subjects must be willing and able to provide informed consent.

Exclusion Criteria:

* Acute symptoms clearly not secondary to HF.
* Subjects with renal disease on dialysis.
* Subjects unable to comply with the study requirements.

Population with suspicion of HF (Outpatient Setting):

Inclusion Criteria:

* Subjects must be at least 22 years of age.
* Subjects must be willing and able to provide informed consent.
* Subjects who present to outpatient centers with suspicion HF.

Exclusion Criteria:

* Symptoms clearly not secondary to HF.
* Subjects with renal disease on dialysis.
* Subjects unable to comply with the study requirements.
* Subjects previously diagnosed with heart failure.
Ext. Long-term Safety Study in CF Patients: Single Arm TIP

The purpose of this extension study is to collect additional 48 weeks of safety data from patients taking TIP who have completed the core study CTBM100C2401. The purpose of collecting second year safety data through this study is to obtain long-term (2 years) safety data of TIP.


Eligibility Criteria:
Inclusion Criteria:

* Completion of the core study CTBM100C2401 and able to comply with all protocol requirements of the extension study

Exclusion Criteria:

* Serum creatinine 2mg/dl, BUN 40mg/dl or proteinuria 2+ or more at the time of entry into the extension
* Use of loop diuretics within 7 days prior to entry into the extension study
* Pregnant or nursing women
* Women of child bearing potential unless using highly effective method of contraception as indicated in the protoco
Nails Versus Plates for Femur Fractures in Dar es Salaam, Tanzania

This is a prospective observational study of patients with femur fractures in Dar es Salaam, Tanzania comparing two different surgical techniques: intramedullary nailing (IMN) and open reduction internal fixation (ORIF) with a plate. The primary outcome is the rate of reoperation for any reason, and the secondary outcomes are fracture healing, return to work, and health-related quality-of-life. The investigators hypothesize that there will be a difference in the rate of reoperation for patients with femur fractures treated with an IMN compared to ORIF with a plate.

The study will be a prospective clinical trial conducted at Muhimbili Orthopaedic Institute (MOI) in Dar es Salaam, Tanzania. All adult patients with diaphyseal femur fractures meeting the eligibility criteria will be invited to enroll. Study subjects will be treated at the discretion of the surgeons at MOI. This could include an intramedullary nail, a plate, external fixation, or skeletal traction. Potential confounders recorded will be age, gender, body mass index, comorbidities, fracture pattern, open versus closed injury, time from injury to presentation, time from presentation to surgery, and associated injuries. The primary outcome considered will be reoperation for any reason. Secondary outcomes will be clinical union, defined as full-painless weight bearing on the injured extremity, radiographic union, return to work, and health-related quality-of-life. Follow up will be scheduled at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after surgery and will include both clinical and radiographic evaluation.

Eligibility Criteria:
Inclusion Criteria:

1. Diaphyseal fracture amenable to operative fixation with an intramedullary nail or plate
2. Age 18 to 65

Exclusion Criteria:

1. Clinical evidence of infection at the surgical site (defined clinically as drainage or erythema)
2. Pathologic fracture
3. Prior surgery
4. Presentation 3 weeks or more after injury
5. Inability or unwillingness to comply with follow up to 1-year