cyrilzakka/clinical-trials huggingface dataset:
Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty

The objective of this study is to determine if peripheral nerve block with liposomal bupivacaine in combination with standard bupivacaine will prolong the duration of block, improve pain scores, and decrease opioid utilization in the post-operative period when compared to peripheral nerve block with standard bupivacaine alone.

This is a prospective, single-blinded randomized clinical trial comparing outcomes in patients undergoing total shoulder arthroplasty (anatomic and reverse) who receive a peripheral nerve block with liposomal bupivacaine in combination with standard bupivacaine versus standard bupivacaine alone. Once consent is obtained, baseline characteristics will be recorded and patients will be randomized to intervention or control. Following surgery, patients will be followed until their 3-week post-operative visit. The primary outcome measure will be the mean difference in patient pain scores over the first 72 hours post-operatively between two groups. Secondary outcomes will include: (1) Total opioid consumption (as measured utilizing morphine intravenous equivalents) in first 72 hours and at 3 weeks (2) Patient perceived duration of block determined as the time patient perceives complete resolution of block (3) Patient satisfaction with pain control at 72 hours, 3 weeks post-operatively and patient reported outcome measures (SANE, SST, ASES, VR-12) at 3 weeks post-operatively.

Eligibility Criteria:
Inclusion Criteria

* All adult patients (\>18 years of age)
* Patients undergoing standard or reverse total shoulder arthroplasty for the primary diagnoses of glenohumeral arthritis or cuff tear arthropathy
* Cognitively intact with the ability to give informed consent as outlined by our institutional review board.
* Patients must be capable of participating in the post-operative electronic survey and / or able to maintain a written diary of events

Exclusion Criteria

* Non-elective cases
* Infection, tumor, trauma
* Weight \< 50 kg
* Patients with any contraindications to regional anesthesia including allergy or hypersensitivity to amide-type local anesthetics
* Patients with allergy to any component of medication regimen e.g. amide- type local anesthetics, oxycodone, hydromorphone, fentanyl
* Chronic pain patients with history of chronic opioid use (defined as 20 mg morphine equivalent / day for greater than 30 days pre-operatively
* Concurrent painful physical condition that may require analgesic treatment that is not related to the shoulder surgery (chronic peripheral neuropathy, radiculopathy, or other neurologic disorder)
* Severe hepatic disease defined by clinical evidence of liver disease with abnormal liver function tests.
* Pregnancy
* Respiratory disease that contraindicates interscalene nerve block (elevated contralateral hemidiaphragm, contralateral pneumonectomy, or severe COPD with FEV1 \< 50% predicted, and 02 dependence)
Lung Ultrasound for the Detection of Pulmonary Atelectasis in the Perioperative Period

Atelectases (collapsed lung areas) of 15-20% of total lung occur in up to 90% of patients who are anaesthetized and intubated. The goal of the present prospective study is to detect atelectatic areas in the perioperative period in the lungs of patients undergoing elective laparoscopic surgery non-invasively and without x-ray exposure. Results of lung ultrasound (LUS) as the experimental method will be compared to the results of Electrical Impedance Tomography (EIT) as the reference technique for the detection of atelectasis. A device for peripheral Oxygen saturation measurement (MASIMO Radical-8) will detect changes in ventilation. The investigators want to confirm or disprove former findings of the appearance of intraoperative atelectases and to prove that ultrasound is a valid tool for detection of atelectases.


Eligibility Criteria:
Inclusion Criteria:

* Male or female,
* age 18 - 75
* BMI \< 30
* Laparoscopic operation

Exclusion Criteria:

* Pregnancy
* Pulmonary infection
* Chronic pulmonary diseases
* Morbid Obesity
Evaluation of Labeling Comprehension and Performance of a New Blood Glucose Meter System

The purpose of the study was to evaluate the acceptability of product user guides for untrained subjects and to evaluate the performance of the system with lay users and healthcare providers (HCPs).

The study evaluated the acceptability of product labeling for performing blood glucose testing with the new blood glucose meter system (BGMS) and for using meter features. Sections of the User Guide and Quick Reference Guide that gave instruction on performing a blood glucose test and operating system features were evaluated, including instructions on connectivity of the system with a computer, meter setup, glucose trends display, and other system features. The study also evaluated the performance of the blood glucose meter system (BGMS) in the hands of subjects and healthcare professionals using capillary blood. Subjects and healthcare professionals provided feedback about the BGMS and its features. Some subjects took the system home to evaluate the robustness of the BGMS.

Eligibility Criteria:
Inclusion Criteria:

* Have type 1 or type 2 diabetes
* Be at least 18 years of age but have not reached their 76th birthday, with approximately 50% (+10%) being less than 55 years of age, at time of consent
* Be willing to complete all study procedures
* Be routinely testing their blood sugar at home (at least once per day)
* Be able to speak, read, and understand English and understand the Informed Consent document
* Be able to read the labeling instructions
* Own or operate a computer for personal or professional use beyond that for email correspondence. Subjects will not have to use their personal computer for the study, but computer use will be required.

Exclusion Criteria:

* Minors \<18 years of age and adults \>75 years of age
* Pregnancy
* Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGMS
* Disorders in the fingertip lancing areas
* Acute or chronic infections, particularly skin infections
* Infection with a blood borne pathogen
* Taking prescription anti-coagulants or having clotting problems that may prolong bleeding. Taking aspirin daily (81mg or 325 mg) is not reason for exclusion
* Hemophilia or any other bleeding disorder
* Having a condition which, in the opinion of the Principal Investigator or designee, would put the person at risk or seriously compromise the integrity of the study
* Working for a competitive medical device company
Neuropathy Walks (Cross-sectional)

Cross-sectional study is to explore the impact of painful neuropathy in the feet on function in persons living with HIV (PLHIV).

The overall goal of this study is to explore the impact of HIV-associated distal sensory polyneuropathy on physical performance, physical activity, and pain pressure threshold.

The aim is to determine if the presence of painful distal sensory polyneuropathy in the feet adversely affects physical performance, physical activity, and pain pressure threshold in PLHIV.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of HIV infection currently treated with antiretroviral therapy (ART)
* cluster of differentiation 4 cell (CD4 cell) count of at least 200 cells/mm3
* 18-64 years of age
* able to read and write in English
* means to travel to a study site
* Additional inclusion for cohort with painful neuropathy in the feet:
* presence of peripheral neuropathy symptoms in feet
* average daily self-reported pain in the feet of at least 3/10 on a 0-10 numerical pain scale
* pain in the feet present for at least the past 3 months
* no changes in medications used to manage pain in the past 4 weeks

Exclusion Criteria:

* current opportunistic infection(s)
* cluster of differentiation 4 cell (CD4 cell) count \<200 cells/mm3
* dementia
* uncontrolled psychiatric disorder
* wounds or sores on the feet
* musculoskeletal or neurological conditions (other than distal sensory neuropathy) that may affect gait
* pregnancy
Maximizing Energy and Reducing Fatigue in Breast Cancer Survivors

This study is testing a program called Maximizing Energy to see if it can help women who have finished breast cancer treatment manage their fatigue. The study has two main goals:

1. Check if the program can be successfully delivered - Researchers will see if women are willing to join and stay in the study, if they follow the program, and if they find it helpful.
2. See if the program works - Researchers will compare Maximizing Energy to a general health education program to see which one helps reduce cancer-related fatigue better.

Participant will:

1. Take tests to see if they qualify and to measure their fatigue.
2. Be randomized to receive Maximizing Energy or Health Education Interventions for 6 sessions over the internet
3. After the sessions and again one month later, repeat some tests to see if their fatigue has improved.


Eligibility Criteria:
Inclusion Criteria:

* adult (18 years and older) pre and post-menopausal female at birth diagnosed with Stages I-IIIa breast cancer,
* completed primary treatment for breast cancer (surgery, chemotherapy, radiation) at least 6 months prior to ensure that fatigue is stable and chronic, - moderate to severe fatigue based on score ≥ 4 on the 7-point Fatigue Severity Scale,
* able to speak and understand English
* has a mobile device that runs on the Apple or Android platform

Exclusion Criteria:

* major depressive disorder, mania, hypomania, psychosis, or substance abuse in the past 3 months and
* disability due to diagnoses other than breast cancer.
The Application of Transcriptomics in the Treatment of Ulcerative Colitis With Ustekinumab

The investigators hope that the present study will highlight new transcriptomic prognostic markers of response to Ustekinumab with the ultimate goal of individualizing treatment and making a more targeted selection of UC patients who will benefit from this biological agent.

Introduction: Optimizing treatment with biological agents is an ideal goal for patients with ulcerative colitis (UC). At present, there are insufficient prognostic markers of response to each biological agent, which makes it difficult to individualize treatment. Recent data suggest that mucosal inflammation patterns and serum cytokine profiles differ between patients who respond and those who do not. These studies mainly focused on anti-TNFα agents and Vedolizumab, while there are no corresponding data for Ustekinumab, which is a monoclonal antibody to interleukins 12 and 23 and has recently been approved for the treatment of patients with UC.

Aim of the study: To highlight prognostic markers of response (clinical and endoscopic) to Ustekinumab, in patients with UC, utilizing information from their transcriptome before starting treatment.

Methods: This is a prospective, single-center cohort study that will evaluate transcriptomic markers of response to Ustekinumab in patients with active UC. The diagnosis of the disease will be based on the established clinical, endoscopic and histological criteria. The patients' recruitment will begin in April 2022, while their consent will be required. The duration of follow-up of patients will be at least 6 months from the start of biological treatment. Patients will undergo endoscopy (sigmoidoscopy or total colonoscopy) with a biopsy of the orthosigmoid before the start of biological treatment and a repeat endoscopy 6 months later. The RNA profile of the patients will be recorded after isolation of the total RNA from colon biopsies. Then, using biostatistics, the transcriptomic profiles of patients who responded to Ustekinumab and those who did not respond to 6 months of treatment, will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Active UC in accordance with applicable diagnostic criteria \[25\] •
* Aged 18 or above

Exclusion Criteria:

* Prior surgical history for UC
* Toxic megacolon
* Infectious complications (Cl. Difficile, CMV infection)
* Patients who received any approved biologic agent (e.g. Infliximab, adalimumab, vedolizumab, golimumab) within the previous 8 weeks or any investigational biologic or other agent in the last 35 days
Prospective Study of Oncologic Outcomes After Laparoscopic Modified Complete Mesocolic Excision for Non-metastatic Right Colon Cancer [PIONEER Study]

This study is a multi-institutional, prospective, observational study evaluation oncologic outcomes of laparoscopic modified complete mesocolic excision (mCME) on right-sided colon cancer.

The primary outcome of this study is 3 year disease-free survival. Secondary outcome measures include 3 year overall survival, incidence of surgical complications, completeness of mCME, and distribution of metastatic lymph nodes.

The present study aims to evaluate the oncological outcomes of laparoscopic mCME on right-sided colon cancer. The right side of the colon was defined as the colon from cecum up to the proximal half of the transverse colon. The number of patients needs to get a 90% power is 250. Patients will be enrolled at five leading centers in South Korea. A complete information leaflet will give to the patients during the first consultation, which will correspond to the enrollment day. The preoperative, intraoperative, and postoperative period will be in complete accordance with the usual care of the center. The baseline demographics and conditions, as well as the perioperative items and the postoperative occurrences, will be recorded through a prior designed case report form. The follow-up encompasses 13 postoperative consultations: 1month, 3 months, after that every 3 months until 36 months.

The primary outcome of this study is 3-year disease-free survival. Secondary outcome measures include 3-year overall survival, the incidence of surgical complications, completeness of mCME, and distribution of metastatic lymph nodes. Review of resected surgical specimens and the operative field after completion of lymph node dissection will be done based on photographs to assess the quality if surgery.

Eligibility Criteria:
Inclusion Criteria:

* 1. Qualitative diagnosis: a pathological diagnosis of adenocarcinoma; the tumor located between the cecum and the right 1/2 of transverse colon
* 2. Patients suitable for curative surgery older than 19 years old
* 3. ASA grade I-III
* 4. Patients without preoperative treatment
* 5. Informed consent

Exclusion Criteria:

* 1. Informed consent refusal
* 2. Patients who need emergency operation; such as perforation, malignant colonic obstruction
* 3. Preoperative imaging examination results show: distant metastasis
* 4. Hereditary colon cancer
* 5. History of any other malignant tumor in recent 5 years, except for cervical carcinoma in situ which has been cured, basal cell carcinoma or squamous cell carcinoma of skin;
* 6. Simultaneous or simultaneous multiple primary colorectal cancer
* 7. Women during Pregnancy or breast feeding period
Quality of Cardiopulmonary Resuscitation Guided by AED vs Telephone-assistance

The aim of this research is to evaluate and to compare the quality of cardiopulmonary resuscitation (CPR) among untrained laypeople under two different scenarios: automated external defibrillator (AED) guided CPR or dispatcher-assisted CPR. Secondarily, to evaluate the quality of the dispatcher-assisted instructions provided from the emergency call center.

A simulation study will beperformed. 42 volunteers selected by non-probabilistic sampling will be randomized in two scenarios of cardiac arrest on mannequin: (A) AED-guided CPR and (T) dispatcher-assisted CPR. Simulations last 9 minutes. The quality of CPR will be evaluated by metric monitoring of the chest compressions and timing of actions. A peer's content analysis of the telephone instructions will be performed using a checklist.

Eligibility Criteria:
Inclusion Criteria:

* untrained laypeople
* Volunteers

Exclusion Criteria:

* Pregnants, leg/arm injuried people, chronic back pain.
Prospective Evaluation of the Preoperative Lymph Node Staging in Patients With Cancer of the Esophagogastric Junction and Stomach

This prospective study includes patients with histologically proven cancer of the esophagogastric junction (Siewert Type II and III) and the stomach. Aim of the study is to evaluate the accuracy of PET-CT for the preoperative assessment of lymph node metastasis. The evaluation includes a combination with standard diagnostic tools (endoluminal ultrasound, CT and diagnostic laparoscopy prior to neoadjuvant therapy). Standardized D2-lymphadenectomy is performed and individual lymph node stations (Nr 1-12 according to the Japanese classification) are histopathologically examined. Furthermore we evaluate the role of the PET-CT for early metabolic response evaluation in patients receiving neoadjuvant chemotherapy.

* Trial with surgical intervention


Eligibility Criteria:
Inclusion criteria:

* Histological prove of adenocarcinoma of the stomach.

Exclusion criteria:

* Recurrent gastric carcinoma
* No informed consent
* Previous malignancy (exception: thyroid, bladder in situ, Cervix in situ)
PENG vs FICB for Hip Fracture in ED Patients

Regional anesthesia for hip fractures has been shown to decrease rates of delirium in elderly patients with hip fractures as well as improve pain compared to systemic opioids. The Pericapsular Nerve Group (PENG) block has recently received attention as an alternative approach to femoral nerve block and Fascia Iliaca Compartment Block (FICB). The investigators seek to evaluate if there is a difference between the PENG and FICB in terms of efficacy of pain control in ED patients presenting with hip fracture. We hypothesize that the PENG block may be superior based on previous research.

Fractures of the proximal femur are a common presentation to the emergency department and are an acutely painful condition. This condition predominantly affects elderly patients who are at risk for delirium and more susceptible to the adverse effects of systemic opioids. Regional anesthesia is an recommended component of pain control for elderly patients with hip fracture. The investigators seek to compare the efficacy of pain control of the Pericapsular Nerve Group (PENG) block with the Fascia Iliaca Compartment Block (FICB).

Previous studies have suggested that the PENG block may be superior to the FICB for pain control and results in less thigh motor weakness. The investigators will compare pain control (by difference in mean VAS score at set time points), systemic opioid use (in mean morphine equivalents prior to surgery), and motor function in patients with hip fractures who receive either block in the ED.

Eligibility Criteria:
Inclusion Criteria:

* Proximal femur fracture

Exclusion Criteria:

* refusal to consent
* hemodynamic instability
* allergy to local anesthetics
* severe injury with instability
* severe medical conditions with instability
Achievement of Goal Resting Heart Rate on B-blockers in Patients With Stable Angina and Hypertension

This is a multicenter survey of Russian data on target heart rate achievement in patients with stable angina and arterial hypertension who are currently treated with beta-blockers for at least 2 months and with no dose change for a minimum of 4 weeks


Eligibility Criteria:
Inclusion Criteria:

* Stable angina I-III class by the Canadian Cardiovascular Society Classification and concomitant primary hypertension
* Subject is on beta-blockers treatment for at least 2 months prior to inclusion into survey, with no dose change for a minimum of 4 weeks

Exclusion Criteria:

* Use of phenylalkylamine and benzothiazepine calcium channel blockers
* Hemodynamic significant mitral and aortic valve disease
* Acute myocardial infarction and unstable angina within 3 months before enrolment
ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial

The present primary therapy of cervical intraepithelial neoplasia (CIN) grade 3 and persistent CIN 2 represents conisation. Surgical treatment can cause perioperative (infection, bleeding in in 5-10%) and postoperative (increased risk of preterm labor) complications, as well as incomplete resections (20%) and risk of recurrence in 5-17%. Imiquimod is an immunomodulating drug, that has been reported to be effective in human papilloma virus-related disease, such as vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VAIN), and anal intraepithelial neoplasia (AIN). The present randomised, placebo controlled, double blind study evaluates the efficacy of a topical treatment with imiquimod for 16 weeks in 60 patients with histologically confirmed CIN 2/3.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian women aged 18 years and older with proven HPV-associated CIN 2/3
* Colposcopy with fully visible transformation zone and lesion
* Safe Contraception
* Signed Informed Consent
* Negative urine pregnancy test
* Able to communicate well with the investigator, to understand and comply with the requirements of the study
* Signed the written informed consent

Exclusion Criteria:

* Women who are pregnant or lactating or become pregnant during the conduct of the study
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
* Participating in another clinical trial within 30 days
* Malignancy
* Immunosuppression (medication, illness)
* HIV- or Hepatitis infection
Clinical Improvement Obtained by Endoscopic Ilio-Psoas Tenotomy (Lesser Trochanter Versus Acetabular Notch)

The purpose of the study is to assess Oxford Hip Score at baseline, at 2 months and at over 12 months.

This is an interventional, comparative, randomized study, in 2 parallel groups, single-blind (the patient does not know which technique he will benefit from, the surgeon will carry out the surgery and will therefore be informed of the result of the randomization ) and monocentric.

Comparative prospective cohort study of an endoscopic tenotomy surgery of the iliopsoas tendon at the level of the lesser trochanter versus at the level of the acetabular notch, in the context of anterior pain for impingement between the iliopsoas tendon and the prosthetic cup in patients after Total Hip Prosthesis.

The study will be proposed to the patient during the preoperative consultation. Patients eligible for surgery will be offered the study. After a reflection period of at least 15 days, patients who agree to participate in the study will be included. Randomization will be done by drawing lots to decide whether the endoscopic tenotomy will be performed at the level of the lesser trochanter or at the level of the acetabular notch. The surgery will be performed under general anesthesia with standardized multimodal analgesia. Whatever the techniques, the approaches, the instruments to perform the procedure and the postoperative course will be identical, as in usual practice.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old;
* Definite diagnosis of iliopsoas tendinopathy due to conflict between the tendon and the prosthetic cup;
* Failure of first-line conservative treatment;
* Planned endoscopic tenotomy;
* Affiliation to the social security scheme;
* Signed informed consent.

Exclusion Criteria:

* Revision total hip prosthesis, multiple operations prior to tenotomy;
* Other surgical or medical interventions planned during the study;
* Participation in another clinical trial, or during a period of exclusion from another clinical trial;
* Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
* Patient deprived of liberty or under guardianship or curatorship or unable to give consent.