cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Adverse Events and How Intravenously Infused Livmoniplimab in Combination With Budigalimab Moves Through the Bodies of Adult Chinese Participants With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC)

Hepatocellular carcinoma (HCC) is a common cancer worldwide and a leading cause of cancer-related death. The majority of participants first presenting with HCC have advanced unresectable or metastatic disease. The purpose of this study is to assess adverse events and how livmoniplimab in combination with budigalimab moves through the body in adult Chinese participants with Locally Advanced or metastatic Child-Pugh A Hepatocellular Carcinoma (HCC).

Livmoniplimab is an investigational drug being developed for the treatment of HCC. There are 2 stages to this study. Stage 1 is a safety run-in. There are 2 treatment arms in stage 1 and participants will receive escalating doses of Livmoniplimab in combination with budigalimab (fixed dose). Stage 2 is dose expansion. There are 2 treatment arms in stage 2 and participants will receive Livmoniplimab in combination with budigalimab in multiple doses. Approximately 20 adult participants will be enrolled in the study across 15 sites in China.

In part 1 (dose escalation), participants will be intravenously infused with escalating doses of livmoniplimab in combination with budigalimab every 3 weeks. In part 2 (dose expansion), participants will be intravenously infused with livmoniplimab in combination with budigalimab in multiple doses every 3 weeks. The estimated duration of the study is up to 2 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic and/or unresectable HCC
* Child-Pugh A
* Barcelona Clinic Liver Cancer stage B or C
* Eastern Cooperative Oncology Group (ECOG) Perfromance Status of 0-1
* Received an immune checkpoint inhibitor in 1L HCC treatment regimen
* Adequate hematologic and end-organ function

Exclusion Criteria:

* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases as outlined in the protocol.
* History of malignancy other than HCC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \> 90%).
* History of autoimmune, immune deficiency, or inflammatory disorders including, but not limited to, inflammatory bowel disease, systemic lupus erythematosus, sarcoidosis, Wegener syndrome, rheumatoid arthritis, antiphospholipid antibody syndrome, Guillain-Barre syndrome, or multiple sclerosis
* History of clinically significant conditions such as but not limited to the following: renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that in Investigator's opinion, would adversely affect the subject's participation in the study.
Phase I Study of OPB-51602 in Patients With Hematologic Malignancies

To determine the maximum tolerated dose (MTD) of OPB-51602


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a confirmed diagnosis of MM, NHL, AML, ALL or CML.
2. Patients who are responsive or have relapsed following standard treatment
3. Patients capable of providing written informed consent
4. Japanese patients age 20 to 75 years (inclusive) at time of informed consent
5. ECOG performance status score of 0-1
6. Life expectancy of at least 3 months
7. Adequate vital organ function
8. Patients who, together with their partner, are willing and capable of using an appropriate method of contraception throughout the trial period and until at least 12 weeks after final IMP administration

Exclusion Criteria:

1. Patients with other primary malignant tumors
2. Symptomatic CNS involvement
3. Ongoing or active infection, or complication that is not controllable by medication or other means
4. Complication of uncontrolled cardiac disease
5. Female patients who are pregnant, possibly pregnant, or lactating, or who wish to become pregnant during the study period
6. Patients who have received another study drug, or who have received chemotherapy, immunotherapy, cytokine therapy, surgery, or radiotherapy for treatment of the primary disease, within 4 weeks prior to enrollment
Assessment of Patient's Satisfaction Regarding the Handiness of Two Hyaluronic Acid Eye Drops Vials

Assess the patient feeling about the handiness of two different vials used to deliver both, unpreserved hyaluronic eye drops.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged 18 and older
* Patient with dry eye for at least 3 months
* Having given his written informed consent

Exclusion Criteria:

* Intolerance to studied products
* Patient's inability to understand the study procedures and give informed consent.
* Patient unwilling to follow the study procedures and visits defined by the protocol.
* Pregnant or lactating women.
* Patient under guardian ship
Intraosseous Catheter Confirmation Study

This is a prospective diagnostic accuracy study investigating the sensitivity and specificity of methods used to confirm correct placement of an intraosseous (IO) catheter. Intraosseous catheters allow medical providers to rapidly administer fluids and medications to critically ill patients when intravenous (IV) access is not present or difficult to achieve. It is standard of care to confirm the correct placement of an IO catheter prior to using it to administer medications or fluids. Three IO placement confirmatory tests will be performed on all research subjects using a standardized protocol. There will be two index tests (the method utilized by most of the medical community evaluating the stability of the catheter, ability to aspirate blood or bone marrow and ability to administer fluids without visible or palpable extravasation as well as the method of demonstrating color flow Doppler only within the intraosseous space during bedside ultrasound exam) and one reference test (ability to visualized a pulsatile waveform when the IO catheter is attached to a pressure transducer). Primary outcome measures of the study will be the determination of correct or incorrect IO catheter placement from the confirmation methods. This data will be used to investigate the primary endpoints of sensitivity and specificity of the confirmation tests as well as inter-operator variability interpreting the raw data from the confirmation methods. Secondary outcomes include complications from the IO catheter. The goal of this study is to see if a more sensitive and specific method of IO catheter confirmation can reliably be performed by different physicians and reduce the amount of complications associated with the catheters. Additional subgroup analyses will be performed in regards to the research subjects BMI and the anatomic site selected for IO catheter use (proximal tibia or humeral head).


Eligibility Criteria:
Inclusion Criteria:

* Patients greater than 18 years of age
* Full code
* Require placement of an intraosseous catheter for emergent resuscitation due to lack of reliable intravenous access
* Capable of undergoing all three intraosseous placement confirmatory methods

Exclusion Criteria:

* Age less than 18 years old
* Pregnant patients
* Prisoner/incarcerated
* Patients unable to undergo all three intraosseous placement confirmatory methods
Impact of Active Breaks in Elementary School Children

The purpose of the study was to evaluate the effects of 12 weeks of Active Breaks on motor, academic and cognitive performance in elementary school children.

The purpose of the study was to evaluate the effects of 12 weeks of Active Breaks on motor, academic and cognitive performance in elementary school children. 159 children were recruited: 92 for experimental group (EG) and 67 for Control Group(CG); after the baseline assessment, the EG classes were randomly assigned into three experimental groups: creativity AB (CREAT; n = 30 ), fitness AB (FIT; n =31 ) and combined AB (COM; n= 31 ) . Specifically, the EG carried out an active break intervention for 12 weeks during curricular time, repeated twice a day, with the duration of 10 minutes, three times a week. CG did not performed any type of active breaks.

Eligibility Criteria:
Inclusion Criteria:

* attending second and third elementary classroom

Exclusion Criteria:

* to be free from injury, which could preclude the PA practice.
The Medacta International AMIStem-P Post-Marketing Surveillance Study

This is a Post-Market Surveillance study of AMIStem-P femoral stem prosthesis


Eligibility Criteria:
Inclusion Criteria:

* Patients with a disease (primary coxarthrosis, inflammatory arthritis of the hip, necrosis of the femoral head, etc.) requiring a total hip replacement
* Patient eligible to receive an uncemented AMIStem-P femoral stem
* Patient agreeing to comply with the study requirements
* Patient willing to provide written informed consent
* Patient affiliated to a social security system
* Patients between 18 and 85 years old

Exclusion Criteria:

* Participation in biomedical research
* Patients younger than 18 years old
* Vulnerable adult patients according to article L1121-6 of the French Public Health Code
* Pregnant or breastfeeding women
* Patients unable to provide written informed consent
Vitamin E and N-acetylcysteine for Preventing Contrast-Induced Acute Kidney Injury After Coronary Artery Catheterization

In a double-blinded randomized clinical trial, all patients undergoing coronary artery catheterization who will met our criteria, will be enrolled into three groups to receive either, vitamin e, n-acetylcysteine, or placebo. The aim of study will be to compare the superiority of vitamin e over n-acetylcysteine for the prevention of contrast-induced acute kidney injury (CIAKI).

Patients aged ≥18 years with chronic kidney disease who undergo coronary catheterization will be enrolled into the study if they meet the inclusion criteria. Patients will be randomly assigned into three groups in a 1:1:1 ratio (Computer-generated random number will be used to assign a patient in either group): we will use simple randomization for assigning each patient in a group. The participants, physicians and outcome assessors will be blinded throughout the trial until the opening of the randomization cold.

All patients will be entered into three group and they will be given normal saline 0.9%, vitamin E, NAC, and the placebos of both regimens. The vitamin E will be given as a soft gel capsule and its placebo will have the same shape and taste. The NAC will be given as an effervescent tablet with a glass of water for consumption and its placebo will also have the same shape and taste. These drugs will be given in addition to the routine hydration therapy which will be given to all patients.

Primary outcome will be the development of CIAKI. Secondary outcomes will be the development of major adverse cardiovascular events and any events till evaluating the CIAKI within 48-72 hours after intervention.

Eligibility Criteria:
Inclusion Criteria:

Patients aged ≥18 years with baseline estimated glomerular filtration rate (eGFR) \<60 mL/min per 1.73 m2 (based on the Modification of Diet in Renal Disease study group formula) who undergo coronary catheterization (i.e. coronary angiography and percutaneous coronary intervention \[PCI\]) will be invited to the study if they meet the inclusion criteria: stable angina with ischemia and indication for coronary angiography, non-ST-segment elevation (NSTE) acute coronary syndrome (ACS) requiring an early invasive strategy, and patients undergoing elective PCI .

Exclusion Criteria:

acute ST-segment elevation myocardial infarction, high-risk NSTE-ACS warranting emergency coronary angiography (\<2 hours), cardiogenic shock, pulmonary edema, overt heart failure and/or ejection fraction \<30%, ACS undergoing coronary angiography or angioplasty during the previous 5 days, sensitivity to contrast medium, recent administration of contrast medium for any reason, AKI, history of dialysis, pregnancy, newly prescribed angiotensin converting enzyme inhibitors or angiotensin receptor blockers, bleeding and/or coagulopathy diseases, and consumption of nephrotoxic drugs, vitamin E, vitamin C, or N-acetylcysteine (NAC) at least 48 hours before intervention.
Messaging Intervention to Increase Medicare Annual Wellness Visits -- the NUDGE AWV Clinical Trial

Medicare Annual Wellness Visits (AWVs) are critical for addressing preventive care needs among older adults, yet the most recent estimates from the Center for Medicare Services suggest less than 50% of eligible patients take advantage of this free healthcare benefit. Behavioral science-informed messaging interventions offer a promising strategy to increase AWV participation by guiding patient behavior. In this study, investigators will evaluate a health system initiative that utilizes personalized email and text messages to encourage Medicare beneficiaries to schedule and attend their AWVs. This approach aims to boost patient engagement in preventive health services, ultimately improving care outcomes for older adult populations

The Centers for Medicare \& Medicaid Services (CMS) recommends Annual Wellness Visits (AWVs) to encourage preventive care and improve long-term health outcomes for Medicare beneficiaries. These visits are designed to provide a proactive approach to healthcare by focusing on identifying risk factors, updating medical histories, and developing personalized prevention plans that promote early detection of diseases. By prioritizing prevention over treatment, AWVs help reduce the overall cost burden on the healthcare system while enhancing patient engagement and empowering individuals to take a more active role in managing their health. Yet despite these benefits, most Medicare members who are eligible for an AWV - at no cost to them - do not complete one.

Behavioral science research suggests that personalized messages, designed to facilitate action, can have significant impacts on health behavior. Studies have found these messaging interventions can increase vaccination rates, cancer screening rates, and other care gap closure.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 or older
* Have either a mobile phone number or an email address on file with the health system
* Included in and non-compliant on the Ascension AWV Clinical Priority Goal measure
* Have consented to receive electronic communications from the health system

Exclusion Criteria:

* Patients whose primary care providers are exempted from the campaign by the health system
* Completed MAWV appointment in previous 30 days
* Has an upcoming AWV appointment scheduled
* Have received a nudge campaign from the Clinical Transformation team in the past 90 days
* Patients who have previously opted out of receiving electronic communications from the health system in our message delivery platform (Salesforce)
Anesthetics to Prevent Lung Injury in Cardiac Surgery

The purpose of this study is to investigate whether the use of inhaled anesthetics, compared to intravenous anesthetics, can affect the amount of lung inflammation and postoperative respiratory complications seen after cardiac surgery.

Randomized, controlled trial involving 45 adult patients undergoing cardiac surgery with cardiopulmonary bypass. Patients will be randomized to receive either inhaled anesthesia with sevoflurane or total intravenous anesthesia (TIVA) with propofol for the maintenance phase of their cardiac anesthetic. Assessment of lung inflammation will take place using fiberoptic bronchoscopic sampling of lung fluid as well as serum collection before and after exposure to cardiopulmonary bypass, and the incidence of compositive postoperative pulmonary complications will take place in the postoperative period.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age 18+)
* Undergoing cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Emergency surgery
* History of severe COPD, emphysema, or ILD
* Recent (\<2wk) or current use of systemic glucocorticoids
* Prior history of pneumothorax
* Allergy/contraindication to intravenous anesthetics
* Personal or family history of malignant hyperthermia or high risk for malignant hyperthermia
Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Electroporation therapy may enhance the ability of chemotherapy drugs to enter tumor cells. Combining chemotherapy with electroporation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of electroporation therapy and bleomycin in treating patients who have locally advanced pancreatic cancer.

OBJECTIVES: I. Determine the safety and surgical feasibility of electroporation therapy with bleomycin in patients with locally advanced pancreatic cancer. II. Determine the overall and progression-free survival of patients treated with this regimen.

OUTLINE: Patients receive bleomycin intratumorally during laparotomy. Approximately 15 minutes after the intratumoral injection, patients receive bleomycin IV over 10 minutes. Approximately 5 minutes after the IV injection, patients undergo electroporation therapy comprising electrical pulses directly to the pancreas and surrounding tissues. Patients are followed weekly for 4-6 weeks and then every 2 months thereafter.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 12-18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Diagnosis of adenocarcinoma of the pancreas Unresectable disease by exploratory laparotomy Involvement of the superior mesenteric artery or occlusion of the superior mesenteric vein-portal vein confluence No extrapancreatic metastases by ultrasound, CT scan, or laparotomy Tumor must be accessible for direct injection of study drug and placement of electrode array

PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: AST and ALT no greater than 3 times upper limit of normal No impaired hepatic function Renal: Creatinine no greater than 1.5 mg/dL No impaired renal function Cardiovascular: No impaired cardiac function Pulmonary: No compromised pulmonary function No pulmonary condition that would potentially require the use of high FIO2 levels Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No prior reaction to bleomycin No fever, infection, or other medical condition that would preclude study Not at high risk for complications associated with abdominal surgery

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior lifetime cumulative dose of bleomycin greater than 400 U Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
Administration of Human Chorionic Gonadotrophin Before Secretory Transformation of Frozen-thawed Embryo Transfer Cycles

Successful embryo implantation is complicated process that requires synchrony between good-quality embryos and receptive endometrium. Human chorionic gonadotropin (hCG), is one of the initial embryonic signals and the major embryoendometrial relationship regulator. This study will be conducted to to investigate the role of parenteral hCG used for the transfer of cryopreserved- thawed embryos with HRT cycles in the outcome of artificially prepared frozen embryo transfer (FET) cycles.


Eligibility Criteria:
Inclusion Criteria:

* Patient age ≤ 38 years.
* Normal 3D transvaginal ultrasound.
* At least two good quality embryos cryopreserved by vitrification.
* No GnRH agonists administration before FET cycle.

Exclusion Criteria

* Endometriosis.
* Uterine anomalies.
* Evidence of hydrosalpinx by hystrosalpingography or ultrasound.
* Evidence of immune disease, hematological or hormonal disorder.
Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastatic Head and Neck Cancer

This trial uses blood tests and questionnaires to study how well participants with head and neck cancer that has spread to other places in the body adhere to swallowing exercises to prevent future disease. Using blood tests to study cytokines (proteins related to the immune system) may help doctors learn if certain levels of cytokines affect whether or not side effects occur and if they put participants at risk for future disease. Questionnaires may help doctors learn about the reasons head and neck cancer participants may or may not follow the swallowing exercises that they are asked to perform after receiving radiation treatments.

PRIMARY OBJECTIVES:

I. To determine whether illness perceptions significantly predict adherence to swallowing exercises at 6 months after the end of radiation.

II. To determine whether sickness behaviors (depression, fatigue, pain)'s effect on illness perceptions are mediated by pro-inflammatory cytokines.

III. To determine whether social support moderates the impact of coping on appraisal of coping.

SECONDARY OBJECTIVES:

I. As a secondary aim, to determine the feasibility and utility of cardiac impedance pre-ejection period measurement as a corollary measure for depression and distress.

II. As a secondary aim, to identify potential genetic markers for swallowing dysfunction which has developed by the 6-month follow-up.

OUTLINE:

Participants provide blood samples prior to and at the 6-month visit after receiving radiation therapy. Participants also complete questionnaires either at home, in clinic, or via internet over 30 minutes prior to receiving radiation therapy and within 14 days of blood sample collection.

After completion of study, participants are followed up periodically for up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Are dispositioned to receive radiation with curative intent for nasopharyngeal, oropharyngeal, hypopharyngeal, laryngeal, or an unknown primary cancer with cervical metastases
* Are stage II-IVb for non- human papillomavirus (HPV)- related oropharyngeal cancer
* Have HPV- related oropharynx cancer that is T1, have nodal involvement with no distant metastasis or have HPV- related oropharynx cancer that is at least T2 with no distant metastasis
* Are stage II-IVb for laryngeal cancer
* Are stage I-IVb for hypopharyngeal
* Are stage I-IVb for nasopharyngeal cancer
* Have stage I-III unknown primary cancer with cervical

Exclusion Criteria:

* Have other cancer diagnoses, except non-melanoma skin cancer
* Had treatment for previous head and neck cancer or radiation to the head and neck
* Have a history of previous head and neck surgery (excluding biopsy and/or tonsillectomy and/or tracheotomy)
* Have a current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g., dysphagia due to underlying neurogenic disorder)