cyrilzakka/clinical-trials huggingface dataset:
Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program

This study will look at the change in participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. Together with the medicine, the participant will also be part of an intensive lifestyle program where the participant will have talks with study staff about healthy food choices, what the participant can do to lose weight and be more physically active. The participant will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. The participant will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. For the first 2 months the participant will be on a low calorie diet. The diet is made up of bars, shakes and 1 low calorie pre-prepared meal for each day. The study will last for about 1.5 years. The participant will have 32 clinic visits with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age more than or equal to 18 years at the time of signing informed consent
* Body mass index more than or equal to 30 kg/m\^2 or more than or equal to 27 kg/m\^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
* History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion Criteria:

* Hemoglobin A1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
* A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
NAVITAS and ENVISION - Study to Characterize Select Objective Metrics & Clinical Outcomes in Chronic Pain Patients With Boston Scientific Neurostimulation Systems

The objective of the study is to characterize the relationship between select objective metrics and clinical outcomes in chronic pain patients treated with Boston Scientific commercially approved neurostimulation systems.


Eligibility Criteria:
Key Inclusion Criteria:

- Is willing and able to comply with completing protocol required assessments and evaluations

Key Exclusion Criteria:

- Has any pain-related diagnosis, medical/psychological condition or external factors that, in the investigator's medical judgment, might confound reporting of study outcomes (e.g. history of pelvic pain, anginal pain, chronic migraine, involved in litigation, workmen's compensation)
Changes of Optical Quality During the Peak of the Covid-19 Pandemic

To explore whether cornea structure, and optical quality are affected by the covid-19 infection.

Participants with healthy corneas admitted to Tianjin Eye Hospital from November 25 to January 20, 2022 were followed up . At the end of the follow-up, the investigators recorded in detail whether the patients had undergone real-time reverse transcriptase polymerase chain reaction (covid-19 RT-PCR tests) testing, testing time and results. The presence of PCR-positive during follow-up is considered to be covid-19 infection; PCR-Negative and no symptoms of infection during the follow-up period are considered not infected; participants with symptoms but no PCR test were excluded from the study.Participants were divided into three groups according to the RT-PCR results and the presence or absence of symptoms of infection during follow-up. pentacam (Pentacam HR, Oculus, Wetzlar, Germany) was performed during follow-up and the results were recorded,and the data was statistically managed and compared.

Eligibility Criteria:
Included Criteria

1. Best corrected visual acuity (BCVA) ≥ 20/20;
2. No other eye diseases except myopia and astigmatism;
3. The cornea was transparent, and there was no cloud or pannus;
4. No clinical manifestation of Eye disease or systemic disease;

Exclusion Criteria:

1. corneal disease;
2. ocular trauma;
3. Pregnant and lactating women;
HW006 LATERAL Thoracotomy

This is a prospective, multi-center,single-arm study that will evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs®) protocol and database.

All participating centers are current INTERMACS® sites in good standing and follow the INTERMACS® protocol and procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Must be ≥19 years of age at time of informed consent to participate in the Intermacs® registry.
2. Subject receives a HeartWare HVAD (The device should be the subject's first VAD implant).
3. Subject signed an Intermacs® informed consent if required by local IRB policy.
4. Subject signed a HeartWare informed consent.

Exclusion Criteria:

1. Subject is incarcerated (prisoner).
2. Subject did not sign the informed consent at sites where waiver of consent was not granted.
3. Body Surface Area (BSA) \< 1.2 m\^2.
4. Prior cardiac transplant or cardiomyoplasty.
5. Subject is receiving a BiVAD.
6. Subject is receiving the device as an RVAD.
7. Subject data is generated from non- Intermacs® centers.
8. Pediatric subjects (\< 19 years of age).
9. Subjects who receive a temporary LVAD
10. Subjects whose device strategy is listed as "Destination Therapy" at the time of implant.
11. Severe Right Heart failure
12. Aortic insufficiency or mechanical aortic valve.
13. Planned concomitant procedure (e.g.valve repair or replacement, CABG, septal defect repair).
14. Known LV Thrombus.
Pancreatic Sphincterotomy Versus Double Wire Technique in Difficult Cannulation

The purpose of the study is to compare two different techniques (pancreatic sphincterotomy (PS) and double wire technique (DGW)) regarding the risk of post-ERCP pancreatitis (PEP) and the success of cannulation in difficult cannulation. For the study, the difficult cannulation is de-fined as situation when the common bile duct has not been cannulated in five minutes, after five attempts or after two pancreatic guide wire passages or when any of those limits is exceeded. The two techniques, the PS and the DGW, will be compared in random fashion. The primary end-point is the risk of PEP .


Eligibility Criteria:
Inclusion Criteria:

* Naive papilla, ERCP indication common bile duct cannulation

Exclusion Criteria:

* No consent to the study
* Ongoing pancreatitis
Adibelimab, Famitinib and Chemotherapy for Advanced NSCLC After PD-1 Inhibitor Failure

This prospective, single-arm trial explores the efficacy of Adibelimab monoclonal antibody combined with Famitinib and chemotherapy in treating locally advanced or metastatic NSCLC patients with negative driver genes who have progressed after PD-1 monoclonal antibody and chemotherapy treatment. The study focuses on assessing progression-free survival (PFS) in 40 participants. Key objectives include evaluating PFS and understanding the progression patterns post-first-line immunotherapy, with an interest in whether switching from PD-1 to PD-L1 inhibitors can overcome immune resistance.

This study is a prospective, single-arm clinical investigation. It aims to assess the effectiveness of the Adibelimab monoclonal antibody in combination with Famitinib and chemotherapy for treating patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) without driver mutations, who have progressed following initial treatment with PD-1 monoclonal antibodies and chemotherapy. The study's primary focus is on evaluating progression-free survival (PFS) among the 40 participants, spanning from December 2023 to December 2026. It intends to explore the therapeutic potential of switching from PD-1 to PD-L1 inhibitors in overcoming immune resistance and identify subgroups that may particularly benefit from this treatment strategy, thereby providing insights into personalized therapy for advanced NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be adults (≥18 years) who have signed an informed consent form.
* They should have an ECOG performance status of 0-1. Diagnosed with stage IIIB-IV NSCLC and have progressed after PD-1 inhibitor treatment.
* Expected to live at least 3 months and have at least one measurable lesion per RECIST v1.1.
* Laboratory test results must meet specific criteria for blood counts, liver and kidney function, and coagulation parameters.
* Patients with stable, treated brain metastases are eligible.
* Women of childbearing potential and men with partners of childbearing potential must agree to use contraception.

Exclusion Criteria:

* Prior therapy with anti-PD-L1, anti-PD-L2, other immune checkpoint inhibitors, or specific cancer treatments.
* Certain cancer types, known mutations, or recent use of systemic corticosteroids or immunosuppressive medications.
* Active brain or leptomeningeal metastases without stability post-treatment, recent severe infections, or major surgery.
* Other conditions that might interfere with the study, such as uncontrollable third-space fluid accumulations, active autoimmune diseases or infections, significant bleeding or thromboembolic events, serious heart conditions, severe allergies to study drugs, other active malignancies, HIV/AIDS, hepatitis B or C infection, or participation in another interventional clinical study within a specified period.
Understanding and Diagnosing Allergic Disease in Twins

The purpose of this study is to gain better understanding of how the immune system works in twins with and without allergic disease. Healthy volunteers are not specifically targeted. Healthy non-allergic study participants may be found through the course of evaluation for the presence of allergies.

The purpose of this study is to study the genetic control and gain better understanding of how the immune system works in twins with and without allergic disease. Although healthy volunteers are not specifically targeted, they might be identified when non-allergic study participants are found through the course of evaluation for the presence of allergies.

Eligibility Criteria:
Inclusion Criteria:

* Twin participants ages 0 to 80 years who are with or without allergy disease.

Exclusion Criteria:

* Patients with special risks attendant to venipuncture will be excluded.
A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula

The aim of this study is to evaluate both clinically and radiologically the efficacy of using the pedicled buccal periosteal flap for closure of oroantral fistula without affecting the original intraoral anatomy.

Background: Oroantral fistula (OAF) is a pathological communication between the oral cavity and the maxillary sinus. A variety of surgical techniques have been developed, with recurrence rates of up to 33%7, mainly due to wound contraction and postoperative infection. To increase the success rates of OAF closure procedures, the use of double-layered closure techniques has developed, but most of these techniques alter the original oral anatomy and may result in significant postoperative morbidity.

Purpose: The aim of this prospective study is to evaluate both clinically and radiologically the efficacy of using the pedicled buccal periosteal flap for closure of oroantral fistula without affecting the original intraoral anatomy.

Patients \& Methods: Ten patients with oroantral fistula will be included in this study. The patients will be examined and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.

Preoperative evaluation: It will include the collection of demographic data, medical status and relevant history of the OAF (etiology, duration, resonance of voice, regurgitation of fluid, infection and previous surgical closure attempts). Cone beam computed tomography (CBCT) scan will be performed to determine the size of the underlying bony defect.

Surgical procedure: The buccal mucoperiosteal flap will be splitted horizontally into two layers: a deep periosteal layer and a superficial buccal mucosa layer. The fistula tract will transected at the bone level, the pedicled deep periosteal layer will be dissected and turned over the fistula at the bone level and will be stabilized using sutures. The superficial layer will be returned to its original position and sutured.

Postoperative evaluation: The patients will be evaluated clinically each week for one month regarding to healing, presence of infection, inflammation and recurrences.

Eligibility Criteria:
Inclusion Criteria:

1. patients have oroantral fistula
2. clear maxillary sinus with no infection

Exclusion Criteria:

1. Patients suffering from any systemic diseases affect healing of soft tissue
2. patients have remaining roots or foreign body in sinus indicated for cald well luc opearation
Learning Curve of Ultrasound-Guided Suprainguinal Fascia Iliaca Block: A Prospective Observational Study

Competence in ultrasound-guided regional anesthesia (UGRA) requires practitioners to acquire cognitive and technical skills. Various difficulties have been identified in anesthesia residents' learning UGRA skills. There is currently no approved UGRA curriculum for residents, and the level of UGRA proficiency achieved during residency may vary significantly. However, no specific training criteria have been defined for this block. It is important to establish criteria to evaluate the adequacy of education.

Compared to other nerve localization techniques, the benefits of UGRA include higher nerve block success rates, faster onset times, reduced local anesthetic volumes, and a lower risk of local anesthetic-related complications. Most experts now consider ultrasound guidance as the standard of care for peripheral nerve blocks. Successfully performing a UGRA procedure requires a triad of three distinct but interrelated skills: image acquisition, anatomical interpretation, and hand-eye coordination.

In our clinic, we routinely perform various nerve block techniques under ultrasound guidance during the perioperative period, both for postoperative analgesia and as a primary anesthetic method. Specifically, in our clinic, the suprainguinal fascia iliaca block (SIFIB) is routinely applied for postoperative analgesia, particularly in orthopedic cases. Before performing a nerve block procedure, resident doctors in our clinic undergo standard training and subsequently perform blocks under the supervision and support of experienced specialists and academicians.

Eligibility Criteria:
Inclusion Criteria:

- Anesthesia residents with less than 2 years of anesthesia experience who have never performed a SIFIB before

Exclusion Criteria:

* Having previously performed a SIFIB
A Study of Two Types of Absorbable Surgical Sutures in the Suturing of Thyroid Surgery Incision

The primary objective of this study is to evaluate the efficacy and safety of two types of absorbable surgical sutures -- STRATAFIX Spiral PDS Knotless Plus Tissue Control Device and STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device (hereinafter referred to as Spiral PDS Plus and Spiral MONOCRYL Plus) used in thyroid surgery to suture surgical incision.

This study adopts a multicenter, prospective, randomized controlled design. The study population are subjects who undergo thyroid surgery.

Before the surgery, subjects are randomized in 1:1:1 ratio to the investigational group 1 (using Spiral PDS Plus), investigational group 2 (using Spiral MONOCRYL Plus) and control group. See the table below for the specific suture levels, materials and techniques of each group.

A blinded central imaging evaluation will be performed on the healing condition of surgical incision on Day 5-7 post-surgery. The subjects will be blinded to the type of suture used for wound closure.

Eligibility Criteria:
Inclusion Criteria:

1. The subject is ≥18, and \<70 years old
2. Planned open thyroid surgery, adopting an anterior cervical curved incision (Kocher's incision);
3. Subject who volunteers to participate in this study, follows the study requirements and follow-up visit and signs the written Informed Consent Form voluntarily;
4. Subject who agrees to not schedule any elective surgical operation except the study surgery before the study is completed;
5. The investigator considers the subject's expected postoperative survival time is not less than 3 months.

Exclusion Criteria:

1. Female subjects who are pregnant or lactation at screening;
2. Preoperative clinical staging shows stage IV thyroid cancer, or cervical lymph nodes dissection is planned;
3. Suspected or confirmed anaplastic thyroid cancer;
4. Peripheral vascular disease affecting blood supply of the neck;
5. Active infectious collagenosis (e.g. scleroderma), or any other disease that would interfere with wound healing;
6. Fasting plasma glucose ≥7.7 mmol/L;
7. History of coagulation diseases;
8. Current oral or intravenous antibiotic therapy for existing disease or infection;
9. History of immunosuppressant use (e.g. steroids) within the last 6 months;
10. Chemotherapy or radiotherapy within the last 6 months, or planned chemotherapy or radiotherapy during the study;
11. Personal or family history of keloid formation or hyperplasia;
12. Current participation in any other drug (within 30 days or within 5 half-lives of the investigational drug) or device clinical study;
13. History of any thyroid surgery, except thyroid fine-needle aspiration biopsy;
14. Planned use of skin adhesive at the incision site;
15. The subject is not suitable for participating in this study for any other reasons, as judged by the investigator.
Study in Women on the Effect of JNJ-64530440 on Oral Contraceptive and Midazolam, and the Effect of a High-fat Meal on JNJ-64530440

The purpose of this study is to evaluate the effect of JNJ-64530440 single- and multiple-dose administration on the single-dose pharmacokinetics of drospirenone and ethinylestradiol (oral contraceptive) in healthy female participants.


Eligibility Criteria:
Inclusion Criteria:

* Must have a body mass index between 18.0 and 30.0 kilogram per meter square (kg/m\^2), extremes included, and a body weight not less than 50.0 kilogram (kg)
* Healthy on the basis of physical examination, medical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the Investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the Investigator
* Must have a negative highly sensitive urine pregnancy test at Day -1 (all participants)
* Must have a negative highly sensitive serum beta-human chorionic gonadotropin pregnancy test at screening (all participants except for postmenopausal participants)
* Must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 90 days after the last study drug administration

Exclusion Criteria:

* Any evidence of heart block or bundle branch block
* History of liver or renal dysfunction (estimated creatinine clearance less than \[\<\] 90 milliliter per minute (mL/min) at screening, calculated by the Modification of Diet in Renal Disease (MDRD) formula), significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the Investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
* Past history of clinically significant cardiac arrhythmias (example \[eg\], premature ventricular contractions, premature atrial contractions, extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome)
* Current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening
* Current hepatitis A virus infection (confirmed by hepatitis A antibody immunoglobulin M \[IgM\]), or Hepatitis B Virus (HBV) infection (confirmed by Hepatitis B surface antigen \[HBsAg\]), or Hepatitis C Virus (HCV) infection (confirmed by HCV antibody), or hepatitis E virus infection (confirmed by hepatitis E antibody IgM) at screening
Methylene Blue Mouthwash for the Treatment of Oral Mucositis Pain in Patients With Cancer

This phase III trial compares the effect of methylene blue mouthwash to standard of care mouthwash for the treatment of oral mucositis pain in patients with cancer. Using methlylene blue mouthwash may improve oral pain in patients with oral mucositis related to cancer and/or cancer treatments compared to usual standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Active cancer diagnosis
* Admitted to the inpatient setting
* Pain related to oral mucositis
* Experiencing oropharyngeal pain
* Able to provide informed consent

Exclusion Criteria:

* Pediatric age (under 18 years old)
* Pregnant or nursing women
* Any contraindication to methylene blue including severe hypersensitivity to methylene blue and patients with glucose-6-phosphate dehydrogenase deficiency (G6PD) due to the risk of hemolytic anemia
: A Comparison of Neuromuscular Transmission in the Muscles During General Anesthesia

The investigators want to compare new muscle relaxation monitoring, TOF-Cuff and TOF-Scan, during general anesthesia. Standard monitoring is using thumb, however it can't be use on every patient. Alternative can be eyebrow muscle or foot muscle.

There is only few old study that compares this muscle and used mivacurium. The study aims to compare TOF-Cuff and TOF-Scan with different sensor and use mivacurium.

In our research in addition to the standard intraoperative monitoring, which includes the assessment of ECG and saturation, the investigators would like to estimate muscle relaxation by using two different methods: a TOF-Cuff which additionally allows to measure inoperative blood pressure and TOF-Scan with different sensor. Our aim is to compare two different methods of muscle relaxation monitoring in patients who will administer muscle relaxant - mivacurium. After receiving painkillers and hypnotics, when the patient is falling asleep, the standard dose of mivacurium 0.2 mg / kg body weight will be administered. Then, painless simultaneous stimulation with TOF-Cuff and TOF-Scan devices will begin. Until intubation, measurements will be made in every 30 seconds and then every 5 minutes until extubation. Extubation will take place according to the guidelines when the TOF-Cuff measurement on the arm is greater than 0.9 - this is the value at which the patient is considered ready to start breathing on his own. The following will be documented: the initiation of drug administration, intubation, possible repeated doses of mivacurium 2 mg, antagonization, extubation, possible side effects (e.g., transient cardiac disturbances, reddening of the skin, lowering blood pressure, bronchospasm, erythema, urticaria) and technical problems.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75
* ASA classification I,II,III
* Elective surgery
* BMI(body mass index) 17-35
* Surgery in the supine position
* Informed consent of the patient

Exclusion Criteria:

* Pregnancy and breastfeeding
* Urgent indications for surgery
* ASA classification \>III
* Neuromuscular diseases
* Polyneuropathy
* Diabetes
* Drug addiction
* Family history of malignant hyperthermia
* Allergic to propofol, fentanyl or mivacurium