cyrilzakka/clinical-trials huggingface dataset:
ISB, SSNB, and PENG Block for Arthroscopic Shoulder Surgery

This study is designed to investigate the post-operative analgesic effect of interscalene nerve block or anterior suprascapular nerve block compared to pericapsular nerve group block in patient undergoing elective arthroscopic shoulder surgery.

Shoulder arthroscopy is a common outpatient operation with an increasing number of indications and complexity. Early postoperative pain immediately following shoulder surgery is a major concern and cause of distress for patients and orthopedic surgeons. Adequate pain control is vital for all aspects of the patient's recovery.

Nowadays, several ultrasound -guided regional anesthesia methods are used for postoperative analgesia. Regional techniques such as interscalene and supraclavicular blocks are usually preferred for shoulder analgesia. Interscalene brachial plexus block (ISB) is the gold standard technique in this area.

Suprascapular nerve block (SSB) has been proposed as an alternative to the ISB in providing analgesia for shoulder surgeries as it has a lower likelihood of causing phrenic nerve blockade.

The pericapsular nerve group (PENG) block has been suggested to be safely applied for analgesia and can be part of surgical anesthesia, but alone is not sufficient for anesthesia in shoulder surgery. The block of this area did not cause motor block or pulmonary complications, nor result in muscle laxity, blocking only the shoulder and the upper third of the humerus.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients.
* ASA class I and II and scheduled for elective shoulder arthroscopy.

Exclusion Criteria:

* Patient who refuses the regional anesthesia technique.
* History of allergy to local anesthetics.
* Local infection at the site of the block.
* History of Pre-existing major organ dysfunction such as hepatic and renal failure.
* History of pre-existing lung disease (COPD, uncontrolled asthma).
* Preexisting upper extremity neurological abnormality or neuropathy.
* Difficulties in comprehending (NRS).
* Chronic opioid users (opioid intake more than 3 months).
Correlation of Arterial and Venous Lactate and Base Deficit Values

The purpose of this study is to determine the correlation between pH, base deficit, and lactate values when comparing venous and arterial blood samples in the pediatric population.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring arterial access and peripheral access. Additionally, patients with a central venous catheter would be included.

Exclusion Criteria:

* Patients who not require arterial access.
Health Group Intervention Among Refugees in Sweden

This prospective intervention study evaluates whether health education and basic body awareness training reduces health care consumption and improves movement quality among refugees in Sweden.

Migration is well known to be stressful and to have a negative impact on Health. Multidisciplinary health-promoting group interventions have significantly improved self-rated health. Further, symptom improvement was shown after implementation of physical activity in form of basic body awareness training. In this study a multimodal team consisted of a physiotherapist, nurse, psychologist, dietician, and physician held sessions of three hours weekly for a period of nine weeks. The sessions started with basic body awareness training, followed by theme discussions on symptoms and health strategies. A total of 54 participants completed the intervention. Health care consumption and movement quality were measured before and after the intervention.

Eligibility Criteria:
Inclusion Criteria: Refugees seeking primary care consultation or rehabilitation unit aged 18-65 years were candidates for inclusion. Based on the health care provider's assessment, patients whose health symptoms could be connected to or increased by the migration process were eligible for inclusion -

Exclusion Criteria:

-
Heparin and Protamine Titration in Cardiac Surgery Under Minimal Invasive Extracorporeal Circulation

During a cardiac surgery under cardiopulmonary bypass it is essential that an appropriate level of anticoagulation is accomplished. To achieve this, the patient is administered heparin. After completion of the surgery, protamine is given to reverse the anticoagulant action of heparin. In this prospective clinical study the researchers will investigate the impact of the two different methods to calculate the required dosage of heparin and protamine; the individualized calculation computed by the Hemostasis Management System Plus (HMS Plus, Medtronic, Minneapolis, MN) device and the weight based. The investigators hypothesize that the aforementioned methods result in different dosages and will elaborate on their impact on postoperative bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* elective cardiac surgery under cardiopulmonary bypass

Exclusion Criteria:

* known blood disorder
* contraindication to heparin administration
Determinants of Coronary Disease in High Risk Families

To define factors contributing to coronary heart disease (CHD) in high risk families.

DESIGN NARRATIVE:

The study followed healthy siblings of patients diagnosed with CHD before age 60. All siblings underwent comprehensive risk factor screening and exercise thallium tomography to identify occult CHD. Follow-up was performed from 6-15 years after entry (mean 8.7 years) to determine the incidence of (1) acute coronary events (sudden death, myocardial infarction, and unstable angina) and (2) progression of occult CHD (repeat exercise thallium tomography). Blood was obtained for genomic DNA, which was tested for polymorphisms of candidate genes which may be associated with premature thrombotic CHD events (platelet proteins GPIIB/IIIa\[PlA1/A2 and Baka/b\] and GPIbB, endothelial nitric oxide synthase, angiotensin converting enzyme, angiotensinogen, D-fibrinogen, plasminogen activator-1, and methylenetetrahydrofolate reductase). Plasma levels of proteins implicated in the pathogenesis of atherosclerosis and thrombotic CHD events were measured (fibrinogen, plasminogen activator inhibitor-1, tissue plasminogen activator, homocysteine, lipoprotein (a), and apo(a) isoform size). DNA was also obtained from living probands and affected siblings to use for genetic linkage studies using affected and unaffectedsibling pairs. Statistical analyses examined (1) whether selected genetic polymorphisms were linked to the occurrence of acute CHD events, and (2) to what extent traditional sociodemographic and biological coronary risk factors or new genetic polymorphisms explained the progression of occult CHD, or the transition from occult to symptomatic CHD events in families with premature CHD.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
The Effects of Repeated Exposure to Antiseptics During COVID-19 Pandemic on Skin Parameters

The global coronavirus disease pandemic (COVID-19) has led to an increased need to wear protective equipment such as wearing face masks and practicing hygiene measures such as more frequent use of antiseptics. These measures can lead to changes in the skin, the development of new inflammatory skin diseases or exacerbation of existing ones, with health professionals especially under the risk of developing these changes. Changes in the skin of the hands due to the use of antiseptics have been observed in a number of studies, however, part of the study was based solely on subjects' self-assessment or clinical assessment of researchers, and only a small part on objective measurements of skin parameters. Also, the impact of prolonged use of antiseptics and the impact of measures to prevent and protect against irritation such as topical application of emollient preparations have not been investigated.

The impact of repeated use of antiseptics in the repeated exposure model on the forearms will be investigated. This model is a modification of the existing model of irritative dermatitis induced by sodium lauryl sulfate where the original irritant was replaced by an antiseptic solution.


Eligibility Criteria:
Inclusion Criteria:

* young, healthy volunteers who gave written informed consent

Exclusion Criteria:

* skin disease, skin damage on measurement sites
* use of corticosteroids, antihistamines and immunomodulators a month prior the inclusion and during the trial
* use of emollients three days prior the inclusion in the trial
* non-adherence to the trial protocol
* pregnancy and lactation
* skin cancer
* immunosuppression
* exposure to artificial UV radiation
A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss

The goal of clinical trial is to test a novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises in overweight adults with moderate to high levels of internalized weight bias. The main question\[s\] it aims to answer are: 1) Can participants lose significant weight loss and 2) significantly reduce internalized weight bias. Participants will take part in a 12 week novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises using videoconferencing software.

The goal of clinical trial is to test a novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises in overweight adults with moderate to high levels of internalized weight bias. The main question\[s\] it aims to answer are: 1) Can participants lose significant weight loss and 2) significantly reduce internalized weight bias. Participants will take part in a 12-week novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises using videoconferencing software. The weight loss approach will be modeled after the Diabetes Prevention Program and the approach utilized to reduce internalized weight bias will be Kristen Neff's self-compassion intervention. Each weekly session will utilize Webex videoconferencing software and last approximately 60-90 minutes.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 25, ≥ 18 years old
* Smartphone access
* WBIS score ≥ 4

Exclusion Criteria:

* Type I diabetes, uncontrolled hypertension, cardiovascular event in past year, any major active kidney, liver, cardio, or cerebrovascular disease,
* musculoskeletal problems that would prevent physical activity,
* current weight loss medication or weight loss program,
* history of bariatric surgery,
* pregnant or breastfeeding,
* eating disorder except binge eating disorder
New Screening and Diagnostic Cut-off Points of PA Patients

This study aims to establish the screening and diagnostic cut-off points for primary aldosteronism patients by a novel small molecule "sandwich method" aldosterone and renin chemiluminescent immunoassay.

Primary aldosteronism (PA) is the most common causes of secondary hypertension. The diagnostic workup for PA is composed of multiple steps and requires measurement of both plasma aldosterone and renin. In terms of assay of aldosterone, most of currently available chemiluminescence assays are based on competitive methods. What is actually detected is the sum of aldosterone and its metabolite aldosterone 3C glucuronide, which causes the value to be about 50%\~100% higher than the actual value. This study aims to establish a new ARR (aldosterone/renin ratio) cutoff point for PA screening and a new cutoff point for PA diagnosis, using a recently developed two-site sandwich chemiluminescence method (Snibe, China) for aldosterone and renin assay.

Hypertensive patients referred to hospitals for screening of PA will be included. All the participants proceed to seated saline infusion test (SIT) and captopril challenge test (CCT) for confirmation. Aldosterone and renin will be measured using chemiluminescent immunoassay on the Liaison analyzer (DiaSorin, Italy) and MAGLUMI X8 (Snibe, China), as well as liquid chromatography-tandem mass spectrometry (LC-MS/MS) platform. According to the experience of Fuwai Hospital, the following diagnosis criteria are proposed: Based on the results of currently used (DiaSorin, Italy), aldosterone \> 8.5ng/dL and renin \< 15μIU/mL after sitting saline infusion conform PA, and aldosterone ≤ 8.5ng/dL excludes PA.

The total number of cases to be enrolled in this study is planned to be 770, including at least 77 positive subjects and at least 406 negative subjects. By drawing the ROC curve, the point corresponding to the maximum value of the Youden index will be selected as the cutoff value, and the corresponding sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, etc. will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* 18-75y;
* persistent hypertension (BP \>150/100 mm Hg), or drug-resistant hypertension;
* newly diagnosed hypertension;
* hypertension and spontaneous or diuretic-induced hypokalemia;
* hypertension with adrenal incidentaloma;
* hypertension and a family history of early-onset hypertension or cerebrovascular accident at a young age (\<40 years);
* status as a hypertensive first-degree relative of patients with PA;
* patients with hypertension and obstructive sleep apnea.

Exclusion Criteria:

* age \<18; BMI ≤ 18.0kg/m2 or ≥ 35.0 kg/m2;
* a diagnosis of secondary hypertension other than PA;
* chronic cardiac dysfunction (NYHA III-IV);
* medium and several kidney dysfunction (Ccr\<30ml/min);
* liver cirrhosis;
* terminal malignant tumor;
* recent use of steroids or oral contraceptives;
* pregnancy or lactation.
Effects for Oral Mucositis Care During Chemoradiotherapy in Cancer Patients: Evaluation of the Bee Products

Oral mucositis is common among cancer patients receiving radiotherapy and chemotherapy. 80-90% of the patients are suffering from the mucositis pain; poor nutrition and even treatment discontinued. Some self-paid medications like glutamine has been used to prevent mucositis before and during radiotherapy/chemotherapy. Randomized controlled trials have shown that honey and propolis may be used for the management of mucositis. Honey demonstrates the most significant antibacterial effects; the green propolis has also been proved to comprise antibacterial, anti-inflammatory, and antioxidant effects. Bee products have been concerned as potential sources of natural antioxidants such as flavonoids, phenolic acids, and terpenoids. This study plan to conduct an RCT comparing the effectiveness of honey, honey and green propolis, and usual care in mucositis of cancer patients.

Outcome Measures

1. Questionnaire collection: oral mucositis grade, pain scale, fatigue scale, dry mouth, nutritional status and quality of life scale.
2. Wearing the smart bracelet: The smart bracelet will automatically detect heart rate variability, heartbeat, sleep and activity status.
3. Saliva sample collection: Test the concentration of IL-1, IL-6, IL-10 and TNF in saliva.
4. Stool and oral flora collection: Test stool and oral flora microbiota.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed with a head and neck tumor.
2. receive chemotherapy or radiotherapy.
3. conscious clear and willing to participate in the research.
4. can communicate in Mandarin or Taiwanese.

Exclusion Criteria:

diabetes, arrhythmia, artificial heart rhythm device, allergic to bee products or alcohol.
Breast Cancer Pathways Program Impact on Patient Shared Decision Making and Experience in Academic and Community Practice

This trial studies the impact of the breast cancer pathways program on the patient experience, including decision making and quality of life. Measuring how the breast cancer pathways program affects decision making and quality of life in patients may help doctors improve cancer education.

PRIMARY OBJECTIVES:

I. Evaluate the impact of breast cancer pathways on patient experience, burden of decision making and quality of life in tertiary cancer center and community oncology practice.

II. Identify modifiable factors that affect provider adoption of breast cancer pathways in tertiary cancer center and community oncology practice.

OUTLINE: Participants are assigned to 1 of 2 groups.

GROUP I: Participants receive standard chemotherapy educational materials. Participants also complete surveys over approximately 22 minutes at the time of first chemotherapy infusion, and approximately 8 weeks after first chemotherapy infusion.

GROUP II: Participants receive personalized information about their cancer, treatment, and side effects. Participants also complete surveys over approximately 22 minutes at the time of first chemotherapy infusion, and approximately 8 weeks after first chemotherapy infusion.

Eligibility Criteria:
Inclusion Criteria:

* Treatment includes intravenous chemotherapy for breast cancer for primary disease as neoadjuvant or adjuvant therapy, or for recurrent and/or metastatic cancer
* Can provide consent
* Are able to comprehend written materials in English or Spanish
* Will receive their chemotherapy at Roswell Park sites in Buffalo or Amherst, New York (NY), or Roswell Park Oncology primary care (PC) sites in Niagara Falls, Amherst, West Seneca, or Jamestown NY

Exclusion Criteria:

* Breast cancer patients receiving oral therapy alone
* Patients who are not able to comprehend written materials in English or Spanish
* Patients who will not receive chemotherapy at a Roswell Park site
* Patients who are not able to comprehend written materials will not be included in this study, as the consent document will be administered in multiple infusion centers that cannot be all staffed daily with a research associate. The study instruments used are standardized tools that have been developed as best as possible with appropriate literacy levels
* Patients enrolled in clinical trials for their breast chemotherapy will be excluded from this study because they will require alternative educational materials that are specific to the trial drugs being administered
Single-dose Safety Study of APD916 in Healthy Volunteers

The APD916-001 study is designed primarily to evaluate the safety and tolerability of APD916 when administered as a single dose

This is a Phase 1, randomized, double-blind, placebo-controlled, single-dose escalation study of up to 9 dose cohorts (1, 2, 5, 10, 20, 30, 45, 70 and 90 mg) each comprising 8 subjects (2 to receive placebo, 6 to receive APD916). Each cohort will be assigned to receive a single dose of APD916. After dosing within the first cohort has been completed and safety data review identifies no tolerability issues, and the principal investigator (PI) and Sponsor have agreed that it is safe to proceed, then subjects in the next cohort may be dosed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females ages 18-45 years
* Body weight of 50-100 kg (110-220 pounds)
* Eligible female subjects will be non-pregnant, evidenced by a negative serum pregnancy test at Screening and a urine dipstick pregnancy test on Day -1 (Check-In); non-lactating; surgically sterile, postmenopausal, or agree to continue to use a medically accepted method of birth control during and for at least 1 month after last study medication administration.
* Eligible male subjects will either be surgically sterile (i.e., vasectomy), for at least 3 months prior to screening, or agree to use a condom with spermicide when sexually active with a female partner who is not using an acceptable method of birth control during the study and for 1 month after.

Exclusion Criteria

* Subject who has donated any blood, or had significant blood loss within 56 days of dosing
* History of smoking or tobacco use within 3 months prior to dosing
* History of epilepsy or other seizure disorder
* Recent history (within 2 years prior to the screening visit) of sleep disorders
* History (within 2 years prior to the screening visit) of ADD or ADHD
* Traveled across more than 3 time zones within 2 weeks prior to dosing
Aspergillus PCR Early Detection in High Risk Oncohematological Patients

ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION

ADVANCE THERAPY ASPERGILLOSIS INVASIVE IN PATIENTS HIGH RISK ONCOHEMATOLOGICAL PCR USING FOR EARLY DETECTION OF ASPERGILLUS

Eligibility Criteria:
Inclusion Criteria:

* Signature of informed consent to participate in the study.
* Adult patients (\> 18 years), diagnosed with acute myelogenous leukemia or myelodysplastic syndrome with chemotherapy (CT) intensive, or admitted to undergo allogeneic hematopoietic progenitor cells, or transplantation with graft versus host disease.
* The patient should be included in this protocol from the start of their chemotherapy or conditioning therapy as reflected in another section.

Exclusion Criteria:

* Employment of antifungal prophylaxis (30 days prior to inclusion) with triazole / polyene with activity against Aspergillus (itraconazole, voriconazole, posaconazole, amphotericin B inhalation).
* Use of other systemic antifungal activity against Aspergillus (amphotericin, terbinafine, flucytosine, echinocandins, etc.). Therefore it will Fluconazole prophylaxis exclusively.
* Background of IFI proven / probable prior
* Probable IFI / tested at the time of inclusion in the study.
* Exclusion will cause a lack of compliance with the inclusion criteria.
* Patients who have a lack of follow biweekly with galactomannan or PCR. Have a bacterial infection not properly treated and controlled before starting empirical antifungal treatment (according to the definition given above). And finally they have a neutropenia of short duration that it creates a significant risk of IFI. This information will not be known logically to include the patient in the study.
Comparison of the Erector Spinae Plane Block Versus Intrathecal Morphine on Post-Cesarean Delivery Analgesia

This study is a Randomized Control Trial comparing the Erector Spinae Plane Block with intrathecal morphine for post cesarean delivery analgesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing scheduled Cesarean delivery

Exclusion Criteria:

* Patients with an ASA score greater than 3
* Allergies to study medications
* Contraindications to neuraxial analgesia
* Patients with chronic pain
* Patients unable to communicate in the study language