cyrilzakka/clinical-trials huggingface dataset:
A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors.

This is a randomized, Open-label, Phase Ib/IIa study to evaluate the efficacy and safety of SPH4336 monotherapy or in combination with Cadonilimab in the patients with selected advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects voluntarily participate in this study and sign informed consent.
2. Expected survival ≥3 months.
3. Patients with advanced solid tumors (including advanced Well differentiated/dedifferentiated liposarcoma) who cannot be treated by radical surgery/other local treatment.
4. According to RECIST v1.1, participants in the dose expansion phase must have at least one measurable lesion.
5. The laboratory test results meet the organ function requirements before starting the study treatment.
6. Prior to the start of the study treatment, the peripheral nerve toxicity of previous anti-tumor drug treatment had returned to ≤ grade 2, and other reversible toxic reactions had returned to ≤ grade 1, but hair loss/pigmentation and other effects were assessed by the investigator as beneficial to the subjects receiving the study treatment. The toxicity of the risk is not subject to this limitation.
7. Subjects agree to use effective contraception from the time they sign the informed consent to the last time they use the study drug.

Exclusion Criteria:

1. Taking anti-tumor traditional Chinese medicines at the time of signing the ICF.
2. Had undergone surgery prior to treatment and hasn't yet recovered from adverse effects of surgery.
3. Had a history of other malignancies before starting the study.
4. History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; NYHA Class ≥II; QTcF≥ 470 ms; LVEF≤ 50%.
5. Diseases affecting drug administration or gastrointestinal absorption before the start of the study and assessed by the investigators could not be included in the study.
6. Previous history of organ transplantation.
7. Before starting the study, HBsAg positive patients with HBV DNA \> 500IU/ mL or 2500 copies /mL or the lower limit of the study center detection, or HCV antibody positive patients with HCV RNA positive, or known HIV-infected patients, or known active tuberculosis.
8. Accompanied by any other serious, progressive, or uncontrolled disease.
9. Subjects with a known history of immune-related adverse events that the investigator determined could not be included.
10. History of severe allergic disease, history of severe drug allergy, or known allergy to any component of the investigational product.
11. Women who are pregnant or breastfeeding.
12. Any other reason for which patients are ineligible for the study as assessed by the investigator.
Screening Women at High Genetic Risk for Ovarian Cancer

RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for ovarian cancer.

PURPOSE: Screening trial to determine the best procedure to detect ovarian cancer in women who have a high genetic risk for developing ovarian cancer.

OBJECTIVES:

* Determine an optimal screening procedure for ovarian cancer, in terms of the most appropriate screening test, criteria for interpretation of results, and screening intervals, in women at high genetic risk for developing ovarian cancer.
* Determine the physical morbidity and the resource implications associated with ovarian cancer screening in these women.
* Assess the feasibility of screening this high-risk population in terms of compliance rates.

OUTLINE: Patients undergo transvaginal ultrasonography of the ovaries (scheduled for the early follicular phase, day 3-6 of the menstrual cycle) and CA 125 measurement annually. Blood samples are collected every 4 months for analysis of CA 125 levels and novel markers.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 5,000 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* First-degree relative (mother, sister, or daughter) of an affected member of a high-risk family defined as one of the following:

  * Family containing 2 or more individuals with ovarian cancer who are connected by first-degree relationships
  * Family containing 1 individual with ovarian cancer and 1 individual with breast cancer and under 50 years of age at the time of diagnosis who are connected by first-degree relationships
  * Family containing 1 individual with ovarian cancer and 2 individuals with breast cancer and under 60 years of age at the time of diagnosis who are connected by first-degree relationships
  * Family containing an affected individual with a mutation of one of the known ovarian cancer predisposing genes
  * Family containing 3 individuals with colorectal cancer with at least 1 individual under 50 years of age at time of diagnosis and 1 individual with ovarian cancer who are connected by first-degree relationships
  * Families where affected relatives are related by second-degree relationships through an unaffected intervening male relative who has an affected daughter are allowed

PATIENT CHARACTERISTICS:

Age:

* 35 and over

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* No prior bilateral oophorectomy

Other:

* No concurrent participation in other ovarian cancer screening trials
Usefulness of Non TNF Usage in RA Patients

The aim of this study is to examine the efficacy and adverse events in the following 3 groups in rheumatoid arthritis patients:

1. Sarilumab treatment for 12 months
2. Tocilizmab treatment for 12 months
3. Abatacept treatment for 12 months


Eligibility Criteria:
Inclusion Criteria:

・RA patients

Exclusion Criteria:

* Not RA patients
* RA patients who are allergic to the drugs, refused to do this research, or who are pregnant
Cardiac Magnetic Resonance Imaging in Patients With Non-Hodgkin Lymphoma or Hodgkin Lymphoma Receiving Doxorubicin

RATIONALE: Diagnostic procedures, such as cardiac magnetic resonance imaging, may help doctors detect early changes in the heart caused by chemotherapy.

PURPOSE: This clinical trial is studying how well cardiac magnetic resonance imaging works in patients with newly diagnosed non-Hodgkin lymphoma or Hodgkin lymphoma receiving doxorubicin.

OBJECTIVES:

* To determine whether early myocardial structural and functional changes can be detected using cardiac MRI in patients with newly diagnosed non-Hodgkin lymphoma or Hodgkin lymphoma receiving doxorubicin hydrochloride-based chemotherapy.

OUTLINE: Patients undergo cardiac MRI with gadolinium contrast prior to initiation of doxorubicin hydrochloride-based chemotherapy and 3 months after completion of six courses of chemotherapy for non-Hodgkin lymphoma and twelve courses of chemotherapy for Hodgkin lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-Hodgkin lymphoma or Hodgkin lymphoma

  o Newly diagnosed disease
* Planning to receive doxorubicin hydrochloride-based chemotherapy solely at the University of Nebraska Medical Center
* Fertile patients must use effective contraception
* Able to lie flat for 90 minutes
* Able to fulfill the requirements of the study

Exclusion Criteria:

* Not pregnant or nursing
* No pacemaker
* No chronic kidney disease stages 3-5 (glomerular filtration rate \< 60 mL/min)
* No metallic foreign body not approved for MRI
* No known hypersensitivity to gadolinium contrast or other required drugs in the study
* No comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this study
* No prior chemotherapy
* No prior radiotherapy to mantle or mediastinum
Randomized Controlled Single-blind Trial to Evaluate the Mobile Tracking of Symptoms in Ambulatory Breast Cancer Patients

Health care has an increasingly demand for mobile applications (App), but studies are rare, which explore the added value and benefits for patient and physician. Patients in different disease groups or physicians from different specialties are likely to have different demands. Research should focus on selected groups to better understand their individual demands. Our study intends to identify the added value of mobile symptom tracking in a selected subgroup of patients. We designed an App for breast cancer patients, who receive ambulant chemotherapy in a breast center. The patients track regularly their well-being and adverse events (AE) with the smartphone- or web-app and share it with the physician in the medical consultation. The data entry was designed to meet patient needs based on previous usability testing.

The reporting of AE and well-being are standardized according to the definitions by CTCAE 4.0 and ECOG-Index to ensure the reliability of patient self-reporting.

The primary outcomes are the number of reported AE, the influence on their subjective well-being and the acceptance of context specific information. We will include 150 participants in this study. The calculated power is 91% respectively 80% for a 10 % improvement of well-being and a 2.2 increase of detected AEs.

The results will be compared to patients without App and to patients with App but without shared information.

* Trial with medical device


Eligibility Criteria:
Inclusion criteria:

* female
* 18 years old and older
* German speaking
* written informed consent
* beginning of intravenous chemotherapy in the breast care center
* diagnosis breast cancer
* personal smartphone (own device)

Exclusion criteria:

- patients who did not meet the inclusion criteria or if compliance could be questioned, e.g. due to a psychiatric illness or personal life.
A Study of a New LY900014 Formulation in Healthy Participants

This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is administered by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will last for about 8 to 9 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)
* Have a body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m\^2), inclusive, at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
* Are nonsmokers, have not smoked for at least 2 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Oral Endocannabinoids in People With Prediabetes and Diabetes

This study evaluates the relationship of endocannabinoids in saliva with inflammation and oral dysbacteriosis present in people with periodontal disease and prediabetes/type 2 diabetes

Diabetes is a disease that affects millions of people worldwide, and the number of cases is expected to continue to increase in the coming years. Type 2 diabetes (T2D) is the most common form of diabetes and is closely related to prediabetes, a condition in which blood glucose levels are high but not high enough to be diagnosed as diabetes. Both prediabetes and T2D increase the risk of cardiovascular disease and are also associated with diseases of the oral cavity, such as dental caries and periodontal disease. The presence of pathogenic bacteria in the mouth has been linked to these diseases. The endocannabinoid system, a signaling system in the body that regulates various biological processes, has been found to play an important role in energy homeostasis and is implicated in obesity, prediabetes, and T2D. This study seeks to investigate the role of endocannabinoids and related lipids in diseases of the oral cavity in the context of prediabetes and T2D. A bidirectional relationship has been observed between periodontitis and T2D, with inflammation playing a central role in both diseases. Although subtle differences in the microbial composition of the mouth have been identified in people with diabetes, the exact mechanisms remain unclear. Our findings could open up a promising line of research on the therapeutic potential of cannabinoid drugs for the treatment of this type of complications in people with prediabetes/T2D.

Eligibility Criteria:
Inclusion Criteria:

* Adults, both sexes (40-65 years)
* With obesity and prediabetes: BMI 30-40 and HbA1c 5.7-6.4
* With obesity and diabetes: BMI 30-40 and previous diagnosis of diabetes

Exclusion Criteria:

* Pregnant women
* Diagnosis of some type of neoplasia or treated with radiotherapy and/or chemotherapy in the last year.
* Ongoing inflammatory diseases (Crohn's disease, ulcerative colitis, arthritis, etc.) and/or anti-inflammatory treatments
* Presence of systemic diseases of vital organs
* Participants in treatment with drugs that could alter salivary flow
* Smokers
* Participants who have not followed the specifications prior to sampling
* Participants who did not sign the informed consent
Conversational Hypnosis in Women Undergoing Imaging for Breast Cancer

The hypothesis is to assess the contribution of conversational hypnosis on anxiety of patients who undergoing for a preoperative breast tracking and improve their care


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years old
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Patient undergoing for a preoperative breast assessment
* Patient must be affiliated to a social security system
* Ability to provide an informed written consent form

Exclusion Criteria:

* Patients diagnosed with major hearing loss
* Patients with schizophrenia
* Patients do not understand the French language
* Pregnant or breast feeding females
* Refusal of the patient to participate in the study
* Persons deprived of liberty or under supervision
Phenotyping Adherence Through Technology-Enabled Reports and Navigation

This study is being conducted to adapt and pilot test a technology-enabled, primary care strategy for routinely monitoring medication use and adherence among older adults with multiple chronic conditions and polypharmacy.

Our study aims are to:

Aim 1: Adapt the PATTERN intervention for use in primary care using input from key stakeholders. During Aim 1, the Northwestern research team will solicit opinions from key informants (patients, clinicians, practice administrators) to ensure PATTERN meets the needs of primary care.

Aim 2: Assess the PATTERN intervention's feasibility and acceptability for use in primary care. During Aim 2, the investigators will conduct a 2-arm, patient-randomized controlled trial at a Northwestern Medicine primary care practice. Participants will be recruited and randomly assigned, using a random number generator application, to either the PATTERN intervention or usual care. Usual care refers to the normal standard clinical practices at the participating practice. Participants will be followed for 6 months.

Eligibility Criteria:
Inclusion Criteria:

Each participant must:

* Be an adult aged 65 or older
* Speak English as their primary language
* Have multiple chronic conditions
* Be prescribed 8 or more medications
* Be primarily responsible for administering own medication
* Receive medical care at the participating primary care practice
* Have access to the internet and an active email address
* Be signed up for the patient portal (MyChart)

Exclusion Criteria:

No participant can:

* Have severe, uncorrectable visual, hearing or cognitive impairments that would preclude study consent or participation
Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)

The primary objective of this trial is to determine the response rate of single agent zoledronic acid using a composite of criteria including the EORTC modified RECIST criteria and the EORTC tumor response criteria for 18F-FDG PET scans.

This pilot study will examine the effect of bisphosphonate (zoledronic acid) in patients with malignant mesothelioma. Evaluation will be limited to patients with standard (CT scans) and functional instruments (FDG PET Scans) of tumor assessment after the administration of standard doses of zoledronic acid (4 mg IV every 3 weeks). We will also explore the biologic effect of zoledronic acid in patients using new serum markers as well as several blood level markers.

Eligibility Criteria:
Inclusion Criteria:

* Males and females \> 18 years of age
* Life expectancy of at least 2 months
* Histologically confirmed unresectable malignant pleural mesothelioma (MPM)
* Measurable disease by CT Scan criteria and/or positive metabolic activity of 18F-FDG PET Scan criteria at screening
* ECOG Performance Status of 0-2
* Laboratory and clinical results within 2 weeks prior to Day 1 must be as follows:

  1. ANC ≥ 1.5 x 109/L
  2. Platelet Count ≥ 100 x 109/L
  3. Hemoglobin ≥ 9g/dL
  4. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
  5. AST ≤ 2.5 x ULN
  6. ALT ≤ 2.5 x ULN
  7. ALK-P ≤ 3 x ULN
  8. Serum creatinine ≤ 1.8mg/dL
  9. Calculated Serum Creatinine Clearance 40 - \> 60ml/min
* Female subjects of childbearing potential and all male subjects must be surgically sterile or consent to use a medically acceptable method of contraception throughout the trial.
* Willing and able to provide written informed consent.

Exclusion Criteria:

* Known central nervous system (CNS) tumor involvement
* Evidence of other active malignancy requiring treatment
* Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class 3 or 4 angina not well controlled by medication, or myocardial infarction within 6 months)
* Known infection with HIV or hepatitis
* Clinically significant arrhythmias demonstrated on electrocardiogram (ECG). Note: subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia (SVT) are eligible.
* Active, serious systemic disease, including active bacterial or fungal infection.
* Subjects undergoing invasive dental procedures, significant periodontal disease or history of osteonecrosis of the jaw.
* Treatment within 4 weeks of the start of the trial with other systemic anticancer therapy.
* Breastfeeding, pregnant, or likely to become pregnant during the clinical trial.
The Effect of Desflurane on Postopertative Cognitive Dysfunction

The purpose of this study is to determine the effect of desflurane on postoperative cognitive dysfunction

Postoperative cognitive dysfunction is a common complication during postoperative period，especially in elderly patients. It is characterized by cognitive decline, inattention and abnormal mental status following surgery. The presence of postoperative cognitive dysfunction is independently associated with poor recovery, increased hospital length of stay and increased mortality.

Desflurane is a widely used volatile anesthetic, associated with shorter emergence times than other volatile anesthetics. This study aims to access the effect of desflurane in preventing postoperative cognitive dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* 1. Written consent given
* 2. Scheduled to undergo elective non-cardiac surgeries under general anesthesia
* 3. ASA Physical Score I-III

Exclusion Criteria:

* 1. Patients with a history of neurological disease, such as Alzheimer disease.
* 2. Patients with a history of psychiatric disease
* 3. Patients with a medication history of antipsychotic drugs.
* 4. Unable to complete neuropsychological testing including patients with severe visual or hearing impairment.
* 5. Patients with preoperative delirium.
* 6. Patients who have severe adverse events, such as cardiac arrest.
* 7. Patients who preoperative MMSE score are below 20;
* 8. Patients who undergo second operation in a short period.
A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adult Male Subjects With Cerebral Adrenoleukodystrophy

A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adults Male Subjects with Cerebral Adrenoleukodystrophy.


Eligibility Criteria:
Key Inclusion Criteria:

* Subject is male and aged ≥18 years.
* Subject has progressive cALD, defined as GdE+ brain lesions.
* Subjects for whom HSCT is not recommended by the investigator or subject is not willing to undergo HSCT.
* Subject has a Loes score ≥0.5 and ≤12 at Screening.
* Subject does not have major functional disability in the Major Functional Disabilities-Neurological Function Score (MFD-NFS), except for "wheelchair bound" or "total incontinence", which will be allowed as these are considered expected symptoms of AMN in the time course of the disease
* Subject does not have major cognitive impairment which would impair his ability to take part in the study as determined by the investigator at screening.

Key Exclusion Criteria:

* Subject who had previous bone marrow transplantation (HSCT) or treatment with ex-vivo gene therapy (eli-Cel).
* Subject has known type 1 or type 2 diabetes.
* Subject has known hypersensitivity or intolerance to pioglitazone or any other thiazolidinedione.
* Subject is taking or has taken honokiol, pioglitazone, or other thiazolidinediones within 3 months prior to Screening.
* Subject with current participation in another interventional clinical study or within 1 month prior to Screening.
* Subject with other medical, neuropsychiatric or social conditions that, in the opinion of the investigator, are likely to adversely affect the risk-benefit of study participation, interfere with study compliance, or confound the study results.