cyrilzakka/clinical-trials huggingface dataset:
Cardiac Magnetic Resonance for Early Detection of Chemotherapy or Radiation Therapy Induced Cardiotoxicity in Breast Cancer (CareBest)

Chemotherapy or radiation therapy-induced cardiotoxicity are well-recognized side effects in patients with cancer. The clinical significance of cardiotoxicity is growing with increasing cancer survivor-ship.

Left ventricular (LV) functional assessment is the standard of reference to diagnose chemotherapy- or radiation therapy-induced cardiotoxicity. The investigators will investigate the usefulness of T1 mapping parameters for early detection and prediction of chemotherapy-, radiation therapy-, or other therapy-induced cardiotoxicity in breast cancer patients This study aimed to achieve early detection of chemotherapy- or radiation therapy-induced cardiotoxicity using T1 mapping magnetic resonance imaging (MRI) and determine a prognostic imaging factor of chemotherapy- or radiation therapy-induced cardiotoxicity in patients treated for breast cancer.

Screening and follow-up cardiac magnetic resonance imaging (CMR) protocols for diagnosis of cardiotoxicity will be conducted in patients with breast cancer who have received or are planned to receive treatment for breast cancer. The protocol will include T1 and T2 mapping and cine imaging of the LV myocardium.

Eligibility Criteria:
Inclusion Criteria:

* Patient with breast cancer

Exclusion Criteria:

* Contraindication of MRI
* Failure with informed consent
* Fail to scan screening protocol
Timing of Antibiotic Prophylaxis for Cesarean Deliveries

The current standard of care to prevent post partum infectious morbidities is to administer antibiotic prophylaxis to all women undergoing a cesarean delivery. The general practice is to administer the antibiotic immediately after the umbilical cord is clamped. This study will compare the incidence of post partum infectious morbidities when the extended spectrum prophylaxis given before the incision time vs. the time of cord clamp.

Some studies suggest that administering the antibiotics prior to skin incision decrease the incidence of post partum infectious morbidities without increasing the risks to the baby from the exposure to the antibiotics. Our investigation will validate these findings in a larger series of patients. We will be conducting a prospective controlled randomized trial that will compare both methods of antibiotic prophylaxis. All patients undergoing cesarean delivery will be eligible except for the patients with the diagnosis of chorioamnionitis. One group will receive Cefazolin 1gm intravenous + Azithromycin 500mg intravenous 30-60 minutes prior to incision. The second group will receive the same antibiotics immediately after cord clamp. The primary outcomes will be endometritis, wound infection, neonatal sepsis evaluations, proven cases of neonatal infection. Secondary outcomes will be patients that required post procedure antibiotics, the duration of treatment for mother and neonate and the pattern of antibiotic resistance in microorganisms isolated and characteristics of the neonatal bowel flora.

Eligibility Criteria:
Inclusion Criteria:

* All Patients undergoing cesarean delivery

Exclusion Criteria:

* Patients diagnosed with chorioamnionitis at the time of decision
* Patients that require an emergency cesarean delivery
* Patients that decline participating on the study
Dose Response Relationship Between Fat Ingestion and Metabolism

The goal of this clinical trial is to compare features of metabolism in healthy, young adults after they consume four meals of differing fat quantity. The main question this trial aims to answer is how does increasing fat quantity impact glucose tolerance, glucose and insulin metabolism, and hormones involved in hunger. Participant will consume four meals consisting of either 20, 40, 60, or 80% energy from fat.

The long-term consumption of high-fat foods can lead to unhealthy changes in the functioning of the body, giving rise to metabolic diseases such as type 2 diabetes. Similarly, short-term high-fat diets have also been shown to disrupt how the body performs but there is a lack of information regarding how a single high-fat meal can disrupt metabolism. Comparing meals of different fat quantity, without changing the overall energy intake (calories), will help us understand the short-term effect of fat ingestion on the functioning of the body and whether increasing the amount of fat in a meal is related to the level of dysfunction in the body. Therefore, the investigators will provide participants with four meals of varying fat quantity and in the period following the meal, the investigators will take blood samples to determine any changes that occur in the body in response to different levels of fat.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.5 and 30.0 kg/m2
* Weight stable for the past 6 months (± 2kg)
* VO2max values within a below average to above average range (38-50 mL/kg and 35-47 mL/kg for 18-25 year old males and females respectively. 35-48 mL/kg and 34-45 mL/kg for 26-35 year old males and females respectively)
* Fasting blood glucose \<6.0 mM
* Resting blood pressure \<140/90 mmHg
* Taking second generation oral contraceptives (females only)

Exclusion Criteria:

* Smoking
* Diabetes, cancer, or other metabolic disorders
* Cardiac or gastrointestinal problems
* Infectious disease
* Barium swallow or nuclear medicine scan in the previous 3 weeks
* Follow a strict vegan diet
* Pregnant or breastfeeding (females only)
* Diagnosis of polycystic ovary syndrome (females only)
Comparison of the Performance of TMS-thermometer With Standard Esophageal or Urine Bladder Thermometer

This Clinical study is preformed in order to estimate the performance of the TMS thermometer and to make a final tuning of the thermometer mathematical algorithm.

Body temperature of men, women and children will be measured using the TMS thermometer.

Each Patient will be measured both with the TMS thermometer and with an esophageal or urinal thermometer as a reference.

Temperature measurement is vital during surgery. Accurate temperature reading can indicate patient's condition and alarm if something is wrong.

Nowadays, during surgeries temperature is measured mostly using an esophageal or a urinal thermometer, both of which are invasive, therefore they complicate the procedure and require time and activity of the medical stuff.

The TMS thermometer combines a noninvasive, biocompatible patch, which is attached to the body, and a receiving unit, which is placed near the body or the vital signs monitors and receives data from the patch. There is no connection between the body and the receiving unit. The measurement is based on a conductive sensor that measures the skin temperature and applies special algorithm in order to calculate the core body temperature.

The purpose of this clinical study is to evaluate the performance of the TMS thermometer and improve its algorithm by comparing its measurement to the esophageal or urinal temperature measurement

Eligibility Criteria:
Inclusion Criteria:

* Men, women and children that are about to have surgery which requires temperature monitoring.
* An informed consent was signed by the patient or his guardian.

Exclusion Criteria:

* The medical staff decides that the patient can't participate.
Heparin-based Wet Suction Method in EUS Fine Needle Biopsy of Solid Pancreatic Mass

The objective of this randomized cross-over trial is to evaluate whether Heparin based wet suction technique, compared with dry suction technique, shall present a higher quality tissue core by using quantitative macroscopic and microscopic scale.

Background \& aim Endoscopic ultrasound guided fine needle biopsy (EUS-FNB) is the main tool for tissue acquisition and pathological diagnosis of pancreatic solid mass because of its superior accuracy and lower complication rate compared to CT-guided biopsy. However, the tissue adequacy and diagnostic yield remained unsatisfactory for 2 reasons. First, the conventional dry suction technique (DST) often get small tissue and 3 or more needle passes (i.e. biopsies) are required to obtain enough specimen. Second, blood contamination of the acquired tissue interfered with microscopic examination. Investigator aim to develop a novel technique to improve tissue acquisition within a fewer needle passes and avoid blood contamination by using heparin-based modified wet suction (H-MWST).

Methods This study will be a randomized crossover clinical trial. Patients with pancreatic solid mass indicated for EUS FNB will be enrolled. EUS FNB will be done by one experienced endoscopists in National Cheng Kung University Hospital. Patients will be randomized in a 1:1 ratio to receive EUS FNB with either dry suction technique (DST) or H-MWST first for the initial 2 needle passes, and then crossover to another suction technique for a total of 4 needle passes. The obtained tissue of each needle pass will be sent separately and examined by a pathologist who is unaware of the procedure order. Procedure related complications will be recorded. The primary outcome will be the acquired tissue quality quantified comparison. The secondary outcome will be the overall diagnostic yield, the specimen adequacy, and complication rate by each suction technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients had pancreatic solid mass on CT scan or abdominal echo image

Exclusion Criteria:

* Anti-platelet and anticoagulant user who cannot stop the medication
* Recent acute pancreatitis episode (within 2 weeks)
* Patient with severe cardio-pulmonary dysfunction
* Pregnant women and adolescent \< 20 years old
Liposomal Bupivacaine (Exparel) for Postoperative Pain Control for Open and Laparoscopic Abdominal Hernia Repair

The purpose of this study is to learn how well Liposomal Bupivacaine (Exparel™) controls post-operative pain in patients undergoing both open and laparoscopic (minimally invasive) abdominal hernia repair surgery.

When a person has surgery, there are a few different standard care options for pain relief. Anesthetic (numbing) drugs can be used to cause a loss of feeling in or around a wound but the effect of the numbing medication can be undone.Pain relieving drugs such as acetaminophen (Tylenol), non-steroidal anti-inflammatory drugs (NSAIDs), and opioid (narcotic) medications can also be taken by mouth or through a vein in your arm (intravenous IV.) However, both NSAIDs \& Opioid drugs can produce negative side effects such as serious difficulty breathing, stopping breathing altogether, low blood pressure, nausea, vomiting, itching, and constipation.

Bupivacaine is one of the commonly used longer-acting numbing medicines (anesthetics). The effect of Bupivacaine or other anesthetics is limited to usually no more than 12 hours when injected around the area of the incision during surgery. Liposomal Bupivacaine (Exparel) could provide good, continuous and longer pain relief than current therapies/treatments commonly used. This can possibly improve patient satisfaction and time to normal activities such as walking.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo an open or laparoscopic abdominal hernia repair.
* Ability to provide informed consent, adhere to study visit schedule, and complete all study assessments.

Exclusion Criteria:

* Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioids or ketorolac.
* Patients who abuse alcohol or other drug substance.
* Patients who are on chronic opioid therapy (taken an opioid 5 of the last 7 days).
* Patients with severe hepatic impairment.
* Patients currently pregnant.
Safety and Efficacy Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients

A study to assess the safety and efficacy of eculizumab in Japanese patients with hemolytic PNH.

The objective of this study was to assess the safety and efficacy of eculizumab in Japanese patients with hemolytic PNH. In addition, the pharmacokinetics (PK) and pharmacodynamics (PD) of eculizumab in Japanese patients were assessed and compared to that of non-Japanese patients who had participated earlier studies of eculizumab treatment in hemolytic PNH.

Eligibility Criteria:
Inclusion Criteria:

* Japanese individuals at least 12 years of age
* Diagnosis of PNH \> 6 months
* At least one transfusion in the past 2 years for anemia or anemia-related symptoms
* LDH level ≥ 1.5 x upper limit of normal within 12 weeks
* Presence of a glycosylphosphatidylinositol (GPI)-deficient red blood cell (RBC) clone (type III cells) by flow cytometry of ≥10%
* Negative serum pregnancy test for women of child-bearing potential

Exclusion Criteria:

* Platelet count \< 30,000/µL
* Absolute neutrophil count ≤ 500/µL
* Known or suspected hereditary complement deficiency
* History of hematopoietic stem cell transplant
* History of meningococcal disease
The Effect of Three Prosthesis Designs in Total Knee Arthroplasty

The purpose of this study is to compare three prosthesis designs to compare three prosthesis designs for total knee arthroplasty and determine the best option for patients in need of a knee replacement.

Total knee arthroplasty (TKA) is a cost beneficial surgery shown to improve pain, function and quality of life in patients with osteoarthritis. In 2015, 6093 patients received primary TKA in Norway. Despite the procedure´s general success, 20% of patients report persistent postoperative pain and/or dissatisfaction with the surgical outcome. Efforts to further improve the procedure have raised considerable debate regarding the role and management of the posterior cruciate ligament (PCL). Prostheses for TKA have evolved into designs that either preserve or sacrifice the PCL. In patients with a functional PCL, the decision of which design is selected depends largely on the favor and training of the surgeon. To further improve TKA patient outcomes, a better understanding of the role of these differing PCL treatments is needed. Thus, the aim of this study is to determine whether patients' perceived outcome, implant stability and clinical outcome differ between 3 TKA implant designs (2 PCL-sacrificing and 1 PCL-retaining). We will conduct a 3-arm randomized controlled prospective trial with 5-year follow-up. This study will have impact on clinical practice by addressing the lack of evidence supporting use of these different types of implants.

Eligibility Criteria:
Inclusion Criteria:

* Primary osteoarthritis
* Non-fixed or fixed varus or valgus deformity less than 15º measured on preoperative standing hip-knee-ankle (HKA) radiographs
* Intact PCL (assessed preoperatively and verified during surgery)
* Age 45 - 75 years (only patients 45 - 70 years will be included in the kinematic RSA)
* Body mass index ≤ 35 kg/m2
* ASA (American Society of Anaesthesiologists) score I or II
* Only patients with KOOS scores above 80 on the Symptoms, ADL (Activities of Daily Living) and Pain subscales will be included in the kinematic analysis

Exclusion Criteria:

* Prior ACL (anterior cruciate ligament) surgery
* Impaired collateral ligaments
* Secondary osteoarthritis of the knee
* Previous osteotomy
* Rheumatic disease
* Flexion less than 90 degrees
* Flexion contracture over 10 degrees
* Peripheral neuropathy
* Malignancy
* Patients who do not speak Norwegian
The Effect of Esketamine on Patients Undergoing Tumor Surgery

Although the acute and chronic postoperative pain of surgical patients has gradually been paid attention to, it has not yet been better resolved.and, the incidence of anxiety and depression in cancer patients is constantly increasing，The new analgesic anesthetic esketamine hydrochloride was launched in China last year，however, in the domestic and foreign literature, there are still few reports of esketamine hydrochloride in postoperative analgesia, and most of them are retrospective and small samples.This study aims to investigate whether esketamine has advantages over traditional opioids in terms of postoperative analgesia, anxiety and depression in cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old;
* Patients undergoing elective tumor surgery
* Use intravenous analgesia pump (PCIA) after operation

Exclusion Criteria:

* Patients with severe infection or respiratory system diseases;
* Severe arrhythmia, unstable angina or myocardial infarction, heart failure;
* Patients with severe diseases of liver, kidney, endocrine or immune system; ·Patients with fever before operation;
* One month before operation Patients receiving chemotherapy, radiotherapy or immunotherapy;
* Drug or alcohol dependence;
* Mental illness, disturbance of consciousness and communication difficulties or inability to understand the questionnaire or refusal to complete;
* Long-term use of antidepressant and anxiety drugs;
* High intracranial pressure High intraocular pressure
Retrospective Study on the Use, Efficiency, and Safety of the At-home Mosie Kit

This study examines the experience of people who have selected to use the at-home insemination Mosie Kit to understand the user's experience, the perceived safety and the efficiency. People who have recently purchased and voluntarily selected to use the Mosie Kit will be invited to complete a one-time online anonymous survey. The results of the survey will be analyzed to understand their experiences.

At-home intracervical insemination (ICI), folklorickly known as the "turkey-baster" method, has been used for decades to increase likelihood of pregnancy. This method works by depositing semen close to or at the cervix. While there are several devices such as over the counter syringes and silicone caps, the creator of the Mosie Baby syringe believes it is designed to be more ergonomic and compatible with a woman's body, easy and safe to use, and results in depositing the semen at or near the cervix opening. The Mosie Kit provides people with an at-home intracervical insemination option which could be used before resorting to more invasive and expensive options such as Intrauterine Insemination (IUI) or in vitro fertilization. There is vast evidence of Mosie's success in the form of happy users who have conceived. There is a desire to learn more about the safety, useability and experience of using the Mosie kit.

This retrospective study will examine the experience of people who have voluntarily chosen to purchase and use the Mosie Kit. The Mosie Kit consists of 2 syringes and a semen collection cup Understanding the safety, useability and experience of using the Mosie Kit will provide additional information about the nature of using intracervical insemination as a viable method for getting pregnant. The information gained will increase understanding of how viable the Mosie Kit is as a first step in trying to conceive and how it is perceived by the people who have chosen to use it.

Eligibility Criteria:
Inclusion Criteria:

* Provide implicit consent by filling out and submitting the survey.
* Used a Mosie Kit to conceive during at least one cycle.
* At least 18 years old.
* Has an active email on file (presumed or they would not have received an invitation to participate. This information will not be verified as there is a desire to keep the survey completely anonymous.)

Exclusion Criteria:

* Never used a Mosie Kit
Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation

This is a multicenter, open-label phase 1/2a study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of JAB-21822 in combination with JAB-3312 in patients with advanced solid tumors harboring KRAS p.G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion phase, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.


Eligibility Criteria:
Inclusion Criteria:

* A written informed consent should be signed by a subject or his/her legal representative before any study-related procedures are performed;
* Subjects with histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors harboring KRAS p.G12C mutation who have failed or lack standard-of-care (SOC) or are unwilling to undergo or intolerant to SOC;
* Expected survival ≥ 3 months;
* Subjects must have at least one measurable lesion as defined by RECIST v1.1. If no measurable lesion untreated with radiation is selected as the target lesion, a lesion treated with radiation ≥ 4 weeks before the first dose and with progression confirmed by radiography may be selected as the target lesion;
* Eastern Cooperative Oncology Group(ECOG) performance status 0-1;
* The organ functions of subjects meet the criteria for the following laboratory parameters at screening;
* Subjects must be able to swallow oral medications without gastrointestinal abnormalities that significantly affect drug absorption

Exclusion Criteria:

* Patients with previous (≤ 3 years) or current tumors of other pathological types, except for cured cervical carcinoma in situ, ductal carcinoma in situ of the breast, prostatic intraepithelial neoplasia, superficial non-invasive bladder cancer, stage I skin cancer (except melanoma); subjects without recurrence or metastasis for \> 3 years after treatment, without current evidence of tumor, and without significant risk of recurrence of previous malignant diseases in the opinion of the study doctor may also be enrolled;
* Serious allergy to the investigational drug or excipients (such as microcrystalline cellulose, etc.);
* Patients with previous (≤ 6 months before the initiation of treatment) or current severe autoimmune diseases (including adverse reactions caused by previous anti- tumor immunotherapies), or autoimmune diseases requiring long-term systemic hormone therapy at immunosuppressive dose levels (prednisone \> 10 mg/day or equivalent drugs);
* HIV, hepatitis B virus(HBV), or hepatitis C virus(HCV) positive;
* Previous (≤ 6 months prior to the first dose) or current evidence of the following diseases: acute myocardial infarction, unstable angina and cerebrovascular accident;
* Subjects who have impaired cardiac functions or clinically significant cardiac diseases;
* Pregnant or lactating women