cyrilzakka/clinical-trials huggingface dataset:
Continuous Preperitoneal Infusion of Local Anesthetic (CPA) Versus Epidural Infusion of Local Anesthetic (EA) in Fast-Track Open Colorectal Surgery

The purpose of this study is to compare the continuous preperitoneal infusion of local anesthetic and continuous epidural analgesia for postoperative pain management in fast-track open colorectal surgery.

Optimized pain relief allowing early mobilization is a prerequisite for enhanced recovery after surgery. Open colorectal surgery is associated with severe and prolonged postoperative pain, especially during mobilization. No analgesic technique has fulfilled all requirements of optimal efficacy: no side effects, low costs, high patient compliance, and improvement in outcome, and consequently, multimodal analgesic techniques have been introduced with a focus on opioid sparing to improve analgesia and recovery. Epidural analgesia (EA) has shown a marked benefit in controlling pain at mobilization, and significantly improves pain management when compared with systemic patient-controlled morphine analgesia. However, eligible patients may not benefit from it because of technical problems or failure of efficiency. Recently, continuous preperitoneal infusion of local anesthetic (CPA) has been shown to be an effective method to relief pain after open colorectal surgery, to reduced morphine consumption and accelerated postoperative recovery. However, this technique has never been evaluated in a fast-track program (ERAS protocol). Moreover, continuous preperitoneal infusions of local anesthetic and epidural analgesia have never been compared.

The purpose of this randomized and double-blinded study is to compare these two techniques on pain control during mobilization, as a prerequisite for enhanced recovery after open colorectal surgery: 1- CPA group: continuous preperitoneal administration of 0.2% ropivacaine using a multilobed catheter positioned between the previously closed parietal peritoneum and the underside of the transversalis fascia + intravenous morphine (patient-controlled analgesia, PCA) as a rescue; 2- EA group: epidural infusion of 0.2% ropivacaine (patient-controlled epidural analgesia, PCEA) + continuous preperitoneal administration of 0.9% saline.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Open colorectal surgery through a midline incision with a primary anastomosis
* American Society of Anesthesiologists (ASA) physical status I to III

Exclusion Criteria:

* Obesity (body mass index \> 35 kg/m2)
* Pregnancy
* Inflammatory bowel diseases
* Contraindication for epidural analgesia (patient refusal, active sepsis, coagulopathy)
* Chronic renal failure (with creatinin clearance \< 30 ml/min)
* Significant hepatic failure (prothrombin ratio \< 50%, factor V \< 50%)
* Chronic pain
* Preoperative opioid consumption
* Preoperative cognitive dysfunction
* Preoperative psychiatric disorders
Exploratory Study Using a New Head-only PET Scanner / ExploreNeuroLF

The "NeuroLF prototype" is a small aperture PET scanner. The NeuroLF prototype will be used with patients, which have just finished their regularly scheduled PET examination on a clinical whole body PET system. The radioactive tracer used for this procedure will still be active. This remaining acitivity will be used for an image acquisition with the NeuroLF prototype without the need for an additional radioactive tracer dose.

The control intervention is be a brain PET scan as part of standard clinical routine. It will be done immediately before the scan on the NeuroLF prototype.


Eligibility Criteria:
Inclusion Criteria:

* Capable of giving Informed Consent as documented by signature (Appendix Informed Consent Form).
* Ability to sit still in the head-only PET scanner for 15 minutes.
* Are scheduled to receive a regular brain PET scan as part of clinical routine.
* Male and Female patients 18 years to 80 years of age.

Exclusion Criteria:

* Contraindications to PET examination,
* Patient height smaller than 160 cm or taller than 200 cm,
* Patient weight more than 120 kg,
* Patient cannot sit upright for at least 15 minutes,
* Metal implants in the head,
* Pregnant or Breastfeeding women,
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug/device within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons.
Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects

This trial will investigate the pharmacokinetics, safety and tolerability of BI 695501 and to establish pharmacokinetic equivalence of BI 695501 to adalimumab.


Eligibility Criteria:
Inclusion criteria:

1. Healthy males
2. Body mass index (BMI) =18.5 to =29.9 kg/m2

Exclusion criteria:

1. Any clinically relevant abnormal finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant previous or concomitant disease as judged by the investigator.
3. Chronic or relevant acute infections. A negative result for Human Immunodeficiency Virus, Hepatitis B and Hepatitis C testing is required for participation.
4. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
5. Intake of prescribed or over-the-counter drugs with a long half-life (\>24 hours) within at least one month or less than 5 half-lives of the respective drug prior to administration or during the trial
6. Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
7. Inability to refrain from smoking during days of confinement at the study center
8. Alcohol abuse (average more than 30 g/day)
9. Current drug abuse
Comparative Study of the Protein C Pathway in Septic and Non Septic Patients With Organ Failure

This is a comparative study performed in 3 groups of patients/subjects: 30 severe sepsis patients, 30 non-septic patients with organ failure, 30 healthy subjects.

The only intervention is a venous blood sampling at the onset of the disease.

The purpose of the study is to compare the PC pathway and expression and inflammatory genes between the 3 groups. The main hypothesis is that systemic inflammatory response and exacerbated coagulation activation are non specific of an infection as a triggering event.

analysis of the PC pathway

* PC activity
* PS activity
* soluble thrombomodulin
* soluble EPCR
* activated protein C
* quantitative flow cytometry on monocytes (thrombomodulin and EPCR)
* whole blood mRNA (Tissue factor, thrombomodulin and EPCR)
* inflammatory gene expression analysis by MLPA

Eligibility Criteria:
Inclusion Criteria:

* severe sepsis patients or:
* non-septic acute organ failure patients or:
* healthy subjects matched for age and sex with severe sepsis patients

Exclusion Criteria:

* criteria for organ failure lasting for more than 24 hours
Shared Decision-Making for Determining Treatment Strategies in Low-Risk Thyroid Cancer

This study is a multicenter cluster-randomized controlled trial conducted in Korea. A parallel, two-group cluster-randomized design will be used to test whether the Shared decision-making Group (SDM; intervention) is different from the Standard Care Group (SC; control).

The primary objective of this clinical trial is to evaluate whether the group provided with a decision support tool for treatment planning (Intervention; SDM group) demonstrates improved satisfaction with the decision-making process compared to the group receiving standard care (Control; SC group) among patients diagnosed with low-risk thyroid cancer who need to determine their treatment plan.

The data are collected from patients who are diagnosed with low-risk PTC and Twenty doctors with various experience of AS will participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older with a thyroid nodule of 1.0 cm or less confirmed as Bethesda category V (suspicious for PTC) or VI (PTC) based on cytopathological examination, or Bethesda category III (atypia of undetermined significance) with a confirmed BRAF V600E mutation.
* Patients with no evidence of distant metastasis, cervical lymph node metastasis, recurrent laryngeal nerve invasion, or tracheal invasion. Additionally, no evidence of extrathyroidal extension (ETE) should be present, and the tumor must not belong to high-risk subtypes of PTC (e.g., diffuse sclerosing, columnar cell, or solid subtype).

Exclusion Criteria:

* Patients who cannot undergo regular follow-up or are expected to have difficulties with follow-up.
* Patients with indeterminate or benign findings on thyroid biopsy.
Comparison of Prosthetic Feet for the Geriatric Patients(CPF)

The purpose of this study is to determine whether the geriatric prosthetic foot 1M10 is superior to the classical SACH (Solid Ankle Cushion Heel) foot, when used by indoor ambulators with a transtibial amputation.

Fourteen limited ambulators , unilateral trans tibial amputees, will be recruited in the orthopedic rehabilitation department in our institute. Participants will be assigned randomly to be fitted with a SACH or a 1M10 Otto Bock foot in their prosthesis.

Both types of feet will be "dressed" to look similarly. All participants will receive the same rehabilitation protocol. After three weeks all participants will be tested functionally in the "10 meter walk test" , and a "Get up and go test". The participants will answer a satisfaction questionnaire that is based on the "Prosthesis Evaluation Questionnaire" and modified according to the aims of this trial.

Pressure patterns and gait parameters will be recorded using a pressure mat. At this time the foot will be switched to the other study prosthetic foot, and the rehabilitation will commence.

At the end of three weeks wearing the new foot the same set of tests will be run again.

The investigators aim to present the difference in satisfaction and in the functional performance of the same participant wearing the two feet.

Eligibility Criteria:
Inclusion Criteria:

* unilateral transtibial amputees
* limited ambulators

Exclusion Criteria:

* do not speak Hebrew
* are not cognitively intact
The Effects of Enzyme-rich Malt Extract on Chronic Constipation

Participants with constipation will take enzyme-rich malt extract for 4 weeks whilst completing a daily bowel habit diary before and during intervention.

This pilot study is an open label, pre-post interventional study to evaluate the use of ERME in the treatment of people with chronic constipation.

This study involves eligible participants that have a diagnosis constipation according to the Knowles-Eccersley-Scott Score (KESS). Participants will receive intervention with a food supplement enzyme-rich malt extract (ERME) at a dose of 15ml twice daily with food.

Before intervention commences, participants will complete baseline breath samples and a 7 day stool diary to assess stool frequency and consistency.

Participants will then receive the ERME as instructed and continue to complete a bowel diary. Then at 4 weeks since starting the intervention, participants will provide another breath sample and complete another set of breath samples.

Eligibility Criteria:
Inclusion Criteria:

* Participant has diagnosis of chronic constipation according to the KESS score.
* Participant can communicate and understand English.
* Participant has a body mass index (BMI) between 18.5 and 34.9kg/m2 (bounds included).

Exclusion Criteria:

* Dependant use of opioid-based medications.
* New use of prokinetic therapy during the study.
* Use of antibiotics in the last 4 weeks.
* Use of probiotics in the last 2 weeks.
* Organic gastrointestinal disease, including inflammatory bowel disease (IBD), coeliac disease and diverticulitis.
* Participant has known mechanical obstruction of the GI tract.
* Participant has diabetes.
* Participant has any hepatic disease.
* Participant has any disease of the CNS.
* Participant has had previous abdominal or colorectal surgery including appendectomy, cholecystectomy, and hysterectomy.
* Participant has intake of ERME for 2 weeks before the study.
The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions.

The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITY™ stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent. Both stents are mounted on the Raptor® Rapid Exchange Stent Delivery System.

This is a multicenter (up to 35 centers), prospective, randomized double blind study. This study has a 2-arm design assessing the safety and effectiveness of the sirolimus-coated Bx VELOCITY stent to the uncoated Bx VELOCITY stent, both mounted on the Raptor Rapid Exchange Stent Delivery System. A total of 350 patients will be entered in the study and will be randomized on a 1:1 basis. Patients will be either randomized to the sirolimus coated or uncoated BX-VELOCITY stent. Patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4, 5, 6, 7, and 8 years post-procedure, with all patients undergoing repeat angiography at 8 months. Medical resource use during the 5 years follow-up period will be collected and analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II) OR patients with documented silent ischemia;
2. Treatment of a single de novo native coronary artery lesion in a major coronary artery in patients with single or multi-vessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment;
3. Target vessel diameter at the lesion site is \>=2.50mm and \<=3.0mm in diameter (visual estimate);
4. Target lesion is \>=15mm and \<=32mm in length (visual estimate);
5. Target lesion stenosis is \>50% and \<100% (visual estimate);

Exclusion Criteria:

1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK \>2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment;
2. Has unstable angina classified as Braunwald III B or C and A I-II-III, or is having a peri infarction;
3. Unprotected left main coronary disease with \>=50% stenosis;
4. Significant (\>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
5. Have an ostial target lesion;
6. Angiographic evidence of thrombus within target lesion;
7. Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated;
8. Documented left ventricular ejection fraction \<=25%;
Patient Descriptors of Cancer-Related Fatigue: a Mixed Methods Pilot Study of Cancer Survivors

The purpose of this research study is to better understand how cancer-related fatigue affects patients and how it's discussed with providers. This information will be used to develop an educational resource (visual aid poster) that could help individuals and their providers talk about cancer-related fatigue and which may help individuals better manage this symptom.

This is a mixed methods cross-sectional pilot study. The target population is adults ≥ 18 years of age who have been diagnosed with cancer, have completed anti-cancer treatment more than six months ago, have no current detectable evidence of cancer, and are experiencing cancer-related fatigue. Participation in this research will involve completion of a six-minute walk test, survey completion, two virtual video interviews, and potentially one additional virtual interview. The interviews will include two 45 minutes for survivors and one 30-minute interview for clinicians. An additional 30-minute interview will be conducted for each survivor and clinician group.

Eligibility Criteria:
Inclusion Criteria:

* Ability to comply with study procedures for the duration of the study

Survivors:

* Written informed consent and HIPAA authorization for release of personal information
* Ability to read/write, understand and converse in English without the need for an interpreter
* Men and women aged ≥ 18 years at the time of consent
* White or Caucasian, Black or African American, or Hispanic or Latino/a
* History of at least one survivorship care visit at the Department of Supportive Oncology at the Charlotte campus or at the Winston-Salem campus of AHWFBCCC
* Completed curative treatment \> 6 months ago for any cancer type, with no detectable evidence of cancer
* Self-reported fatigue score of ≥ 4 on the Numerical Rating Scale

Clinicians:

- Currently see oncology patients (any cancer type) for survivorship care at the Department of Supportive Oncology at the Charlotte campus or at the Winston-Salem campus of AHWFBCCC

Exclusion Criteria:

Survivors:

* Continuing maintenance therapy or other cancer-related treatment (i.e. immunotherapy or hormonal therapy)
* History of or current severe or untreated depression
* Hemoglobin \<11g/dL at last CBC SOC lab collection
* History/diagnosis of dementia
* Factors or conditions, for which participation may (1) not be in the best interest or (2) interfere with study assessment results (e.g. medical comorbidities, primary brain tumor/metastases)
* No access to internet/Wi-Fi

Clinicians:

- None
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp When Administered as a Bolus in a Continuous Subcutaneous Infusion Regimen in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) properties of FIAsp (faster-acting insulin aspart) and insulin aspart (NovoRapid®) given as a bolus on top of a basal continuous subcutaneous insulin infusion (CSII).


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-64 years (both inclusive) at the time of signing informed consent
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index (BMI) 18.5-28.0 kg/m\^2 (both inclusive)
* Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
* Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
Assessment of Different Forms of Creatine

The purpose of this study is to examine the pharmacokinetics of creatine nitrate supplementation.

Creatine nitrate contains several nutrients that may increase anaerobic exercise performance. Theoretically, dietary supplementation of creatine nitrate during resistance training can improve the quality of training leading to greater changes in strength, power and fat free mass. Endothelial function measured by flow-mediated dilation (FMD), a non-invasive vascular health parameter that can be measured via ultrasonography, is a predictor of cardiovascular disease risk which precedes traditional risk markers. Diet, physical activity and pharmaceutical interventions can all impact vascular function and health. The purpose of this study is to determine the acute vascular response of creatine nitrate supplementation on FMD by analyzing the pharmacokinetics of creatine nitrate supplementation.

Eligibility Criteria:
Inclusion Criteria:

* you are an apparently healthy and recreationally active male between the ages of 18 and 40;

Exclusion Criteria:

* you have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmia and/or cardiovascular disease;
* you are currently using prescription medications;
* you have a history of smoking;
* you drink excessively (i.e., 12 drinks per week or more);
* you have a recent history of creatine supplementation within six weeks of the start of supplementation;
French Register of Duodenal Adenomas Characterization and Evaluation of Endoscopic Mucosectomy

Sporadic duodenal adenomas are rare. As they are highly pre neoplastic, they should be removed and endoscopic mucosectomy is recommended during digestive endoscopy. However, this technique, albeit less dangerous than surgery, is associated with complications such as haemorrhages, perforations, and more relapse than that can be observed for colorectal adenomas. As no prospective data have been published this French multicenter study aim to analyze results of this technique under standardized and secured procedure.

All investigators are expert in therapeutic endoscopy in tertiary centers and are member of a group of clinical researcher involved in that field (" GRAPHE " (Groupe de Recherche et d'Action des Praticiens Hospitaliers en Endoscopie interventionnelle). Results are highly expected among the international society of gastroenterologists who need to confirm the efficacy of endoscopy and define optimal conditions for performing adenomas resection in this location Primary End Point is the two years recurrence rate. Secondary End Points are frequency and type of complication after standardized endoscopic mucosectomy of duodenal adenomas, frequency and type of complications after a second endoscopic mucosectomy and patient's characteristics Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic mucosectomy will be included. Non-inclusion criteria concern patients with previous endoscopic resection, lesion involving the major papilla, sub mucosal lesions, familial adenomatous polyposis and use of antiplatelet agent during the five last days.

Hundred and twenty patients will be included and followed 2 years after mucosectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic mucosectomy

Exclusion Criteria:

* patients with previous endoscopic resection,
* patients prsenting lesion involving the major papilla, sub mucosal lesions
* patient with familial adenomatous polyposis
* patient undergoing use of antiplatelet agent during the five last days