cyrilzakka/clinical-trials huggingface dataset:
Treatment With MK6592 and an Anti-cancer Drug in Patients With Advanced Solid Tumors (6592-001)

A study to evaluate safety and tolerability of MK6592 in combination with an anti-cancer drug in adult patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced solid tumors (metastatic or local) unresponsive to standard therapy, progressed on standard therapy, or no standard therapy exists. No limit to the number of prior treatment regimens
* Patients may be fully active without physical restrictions, ambulatory with restrictions on strenuous physical activity, or ambulatory and capable of self-care but not work activities (i.e., Eastern Cooperative Oncology Group performance status of greater than or equal to 2)
* Demonstrates adequate organ function (liver, kidneys, hematologic)

Exclusion Criteria:

* Chemotherapy or radiation therapy within 2 weeks of dosing; or unresolved side effects(s) from prior treatment regimen
* Participation in an investigational study within 14 days of dosing
* Primary central nervous system tumor
* Active brain or spinal cord metastases. Patients who completed a course of therapy for CNS metastases may be eligible if considered clinically stable for 3 months prior to study entry
* Symptoms from fluid in the abdomen or around the lungs
* Requires certain drugs or other products known to be metabolized by the liver enzyme CYP3A4
Biomarkers of Brain Injury in Critically-Ill Children on Extracorporeal Membrane Oxygenation

The BEAM study is a multicenter, prospective, observational study in children supported on extracorporeal membrane oxygenation (ECMO). The primary goals of this study are to develop and refine a brain injury multimarker panel for accurate neurologic monitoring at the bedside and early classification of mortality and disability outcomes of critically ill children supported on ECMO.

The specific aims are to:

1. Determine if circulating levels of brain injury markers during ECMO and brain MRI abnormalities within 6 weeks after ECMO are associated with survival at 18 months after ECMO with a score ≥85 on the Vineland Adaptive Behavior Scales, third edition (VABS-III).
2. Determine whether the presence and degree of inflammation during ECMO and markers of neuroinflammation on brain magnetic resonance spectroscopy (MRS) within 6 weeks after ECMO are associated with survival at 18 months after ECMO with a score ≥85 on VABS-III.
3. Determine whether metabolic and lipid neuroinflammatory pathways will distinguish between at-risk for, acute, and recovery phases of neurologic injury (NI) during ECMO.

Eligibility Criteria:
Inclusion Criteria:

* Children (2 days to \<18 years) cannulated onto ECMO and admitted to a pediatric or cardiac Intensive Care Unit at participating institutions.

Exclusion Criteria:

* ECMO cannulation at an outside institution with transport to a study site \>24 hours after ECMO initiation
* Limitation of care (e.g., family planning to withdraw support)
* Brain death evaluation within 24 hours of ECMO cannulation
* Inability to speak or understand English or Spanish
* Pregnancy.
Real World Assessment of People Living With Chronic Hepatitis B in Australia

The REACH-B study establishes an observational cohort study of people living with chronic hepatitis B from a national network, including a diverse range of services, to characterise and monitor hepatitis B linkage to care and treatment requirements amongst this population.

Participants presenting to participating clinics for HBV care within the previous 12 months will be identified and enrolment data will be collected including demographics, laboratory parameters, liver disease assessment, treatment history and clinical management. Follow-up data on HBV treatment and clinical management, liver disease stage and laboratory parameters will be collected at each subsequent visit or at minimum every 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. All individuals diagnosed with chronic hepatitis B in the participating study sites are eligible to be included (both newly diagnosed cases and those diagnosed in the past).
2. 16 years of age or older.
3. Attended the health service for HBV care within the prior 12 months from study commencement (retrospective recruitment) OR Attending the health service for HBV care from study commencement (prospective recruitment)

Exclusion Criteria:

1. Nil
Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin

This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma. Malignant pleural mesothelioma have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the malignant pleural mesothelioma cells will starve and die.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven unresectable MPM of biphasic or sarcomatoid histology
* Naïve to chemotherapy or immunotherapy
* ECOG PS 0-1
* Expected survival of at least 3 months
* Age 18 years or over (there is no upper age limit)
* Measurable disease by modified RECIST criteria for MPM for local pleural disease and RECIST 1.1 criteria for metastatic lesions
* Written (signed and dated) informed consent and must be capable of co-operating with treatment and follow up
* Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

* Radiotherapy (except for palliative reasons) in the previous two weeks before study treatment
* History of unstable cardiac disease
* Ongoing toxic manifestations of previous treatments
* Symptomatic brain or spinal cord metastases (patients must be stable for \> 1 month post radiotherapy or surgery)
* Major thoracic or abdominal surgery from which the patient has not yet recovered.
Hyperbaric Oxygen Treatment in Patients With White Matter Hyperintensities

The primary purpose of this study is to assess whether hyperbaric oxygen treatment improves neurological function in patients who exhibit white matter hyperintensities on MRI examination.

The secondary goal of this study is to determine if it is possible using MRI to discern a difference in perfusion of central nervous system tissue in regions of white matter hyperintensities after hyperbaric oxygen administration as compared to hyperbaric air.

Consecutively enrolled patients will be assigned to hyperbaric oxygen or hyperbaric air by random number. Physicians supervising the hyperbaric treatments and the treating technicians, the evaluating neurologist, and the interpreter of the MRIs will be blinded regarding patient treatment status. All patients who receive placebo will be offered treatment with hyperbaric oxygen.

Eligibility Criteria:
Inclusion Criteria:

* Over 50 years of age
* White Matter Hyperintensities on MRI of brain
* Two or more symptoms and/or Neurological impairments e.g. gait disturbance, dysequilibrium, decline in cognitive function, upper motor neuron deficit, dysmetria, hyper-reflex or unilateral increase in muscle tone

Exclusion Criteria:

* Contraindications to hyperbaric oxygen therapy e.g. pulmonary emphysema or bullae, claustrophobia, seizure disorder
* Inability of the patient to tolerate pressurization e.g. eustachian tube dysfunction
* Extreme cognitive impairment
* Major Depression
* Other uncontrolled co-morbidities e.g. diabetes, hypertension, thyroid disorders, carotid artery stenosis (over 70%), renal or hepatic dysfunction
* History of brain tumor, head trauma, electroshock therapy,brain irradiation or migraine headaches
Bone Microstructure by Using HR-pQCT in Long Courses After Gastrectomy

Osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the deterioration of bone architecture, is a serious complication in the long course after gastrectomy. The aim of the present study was to evaluate osteoporosis by using high-resolution peripheral quantitative computed tomography (HR-pQCT) in the long course after gastrectomy. In total gastrectomy and distal gastrectomy groups, at least 5 years should have elapsed since gastrectomy.

The patients after gastrectomy loss appetite and decrease the weight. Total gastrectomy especially cause severe sarcopenia and metabolic change. Osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the deterioration of bone architecture, is a serious complication in the long course after gastrectomy. The primary tools for assessing volumetric density and bone structure are quantitative computed tomography (QCT) and more recently, high-resolution peripheral quantitative computed tomography (HR-pQCT). However the validation of osteoporosis with HR-pQCT in the long course after gastrectomy remain elusive. The aim of the present study was to evaluate osteoporosis by using HR-pQCT in the long course after gastrectomy. In total gastrectomy and distal gastrectomy groups, at least 5 years should have elapsed since gastrectomy.

Eligibility Criteria:
Inclusion Criteria:

* At least 5 years have elapsed since DG or TG due to gastric cancer
* Provide signed informed consent

Exclusion Criteria:

* pregnancy
* Current use of the following osteoporosis agents; Teriparatide, Denosumab, and bisphosphonate
* Hyperthyroidism
* Hyperparathyroidism
* Present malignancy (except in situ carcinoma)
* Any condition that required chronic (greater than three months cumulative and greater than 5 mg/day) glucocorticoid therapy
* Other diseases which affect bone metabolism
* Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
* Received \> 3 months (or equivalent) of osteoporosis treatment
* Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).
Full-Endoscopic vs Open Discectomy for the Treatment of Symptomatic Lumbar Herniated Disc

The purpose of this study is to compare the clinical and radiographic outcomes of full endoscopic lumbar discectomy versus open lumbar decompression for the treatment of lumbar herniated discs in which the patient's leg pain is greater than back pain.

The study will be performed utilizing a prospective multi-center randomized model. Approximately 7 centers will be included in the study as listed above. Patients will be informed of clinical trial and asked if they would like to participate. Patients are informed that participation is optional. Patients may withdraw from study any time prior to or after surgery. Patients will be randomized 2:1 ratio endoscopic:open surgery. Both the endoscopic and open surgical techniques are utilized in standard of care. If a subject requires an open surgery approach (based on the surgeons assessment at the time of surgery pre or post incision) after they are randomized to the endoscopic arm, they will be switched to the open arm and included in the open crossover arm of the study.

Study procedures will occur at the following time points; Pre-op, 6 wk, 3 mon, 6 mon, 1 yr and 2 yr follow-up.Subjects will complete questionnaires that assess pain level and location, functional capacity, work and health status, medication usage and duration of symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. Patient equal to or greater than 18 years old.
2. Patients with single level para-central herniated discs from L1-S1.
3. VAS (Visual Analog Scale) leg \> 40 mm.
4. Leg pain must be greater than back pain.
5. Minimum 6 weeks conservative treatment unless motor strength U\< U4/5 and or deteriorating neurologic function.

Exclusion Criteria:

1. Lateral/subarticular, far lateral disc herniations
2. Multi-focal (multi modal) disc herniations
3. Symptomatic multiple level disc herniations
4. Active infection either spinal or otherwise
5. Prior history of lumbar spinal infection at any level
6. Spinal tumor in lumbar region
7. Dynamic (any grade) or fixed spondylolisthesis more than 3mm
8. Disc extrusion that is more superior than most inferior aspect of superior pedicle above index disc level
9. Disc extrusion that is more inferior than the middle aspect of inferior pedicle below the index disc level
10. Presence of unilateral or bilateral pars inter articularis defects (spondylolysis)
11. Disc herniation which is significantly calcified
12. Contra-lateral leg pain U\>40 mm
13. History of peripheral diabetic neuropathy
14. Significant central stenosis with history of neurogenic claudication
15. Pregnancy
16. Facet cyst on symptomatic side
17. Cauda Equina syndrome past or present
18. Patients cannot have had prior lumbar surgery including IDET (Intradiscal Electrothermal Therapy) or other percutaneous surgical procedures.
19. Significant vascular claudication
20. History of radiation to the spinal column
21. History of malignancy of any type within 2 years of consideration of enrollment
Efficacy and Safety of VB119 in Subjects With Membranous Nephropathy

This study is a Phase 1b/2a, open-label, sequential-cohort, dose escalation, and dose expansion study to evaluate the safety, tolerability, PK, and PD of VB119 in subjects with primary MN


Eligibility Criteria:
Inclusion Criteria:

1. Is ≥ 18 years of age at the time of informed consent;
2. Has a kidney biopsy-proven diagnosis of primary MN within the past 10 years; Note: It is preferable that subjects enrolled have kidney biopsy tissue samples that are positive for anti-PLA2R antibody staining. Subjects with kidney biopsy-proven diagnosis of primary MN \>10 years and ≤20 years that meet all other eligibility criteria may be enrolled after discussion with the Medical Monitor.
3. 3. Has a documented laboratory history of nephrotic range proteinuria (defined as either greater than or equal to 3.5 g total protein per 24-hour urine collection or greater than or equal to 3.5 g/g UPCR by spot collection) AND has proteinuria with a UPCR greater than or equal to 2.0 g/g based on 2 consecutive spot urine (first morning void) sample collections obtained within 14 days of each other during the Screening Period. Both samples must qualify;
4. Has systolic blood pressure (BP) \<160 mmHg or diastolic BP \<100 mmHg after 5 minutes of rest at Screening;
5. Is willing and able to provide written informed consent prior to Screening;
6. Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or postmenopausal, defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone in the postmenopausal range at Screening, based on the central laboratory's ranges;
7. Female subjects of childbearing potential (ie, ovulating, premenopausal, or not surgically sterile) and all male subjects must use a medically accepted, highly effective contraceptive regimen during their participation in the study and for 125 days after the last administration of study drug.
8. Male subjects must agree to abstain from sperm donation through 125 days after administration of the last dose of study drug.

Exclusion Criteria:

1. Has an eGFR \<45 mL/min/1.73 m2 at Screening utilizing the Chronic Kidney Disease Epidemiology Collaboration formula confirmed by the central laboratory;
2. Has an absolute neutrophil count \<1.5 x 10/L;
3. Has a white blood cell count \<3.0 x 10/L;
4. Has secondary causes of MN (eg, malignancy, hepatitis B or C, human immunodeficiency virus \[HIV\], systemic lupus erythematosus \[SLE\], or other autoimmune diseases \[eg, thyroiditis\], drug-induced);
5. Has a diagnosis or history of SLE (including non renal disease);
6. Has type 1 or 2 diabetes mellitus;
7. Has an acute, chronic, or latent infection, including tuberculosis, hepatitis, HIV, or chronic urinary tract infections;
Diet Education Program for Stage I-IV Colorectal Cancer Survivors

This pilot trial evaluates the feasibility of a group diet education program for stage I-IV colorectal cancer survivors. Providing a nutrition education program for colon and rectal cancer survivors may help them have better access to the tools necessary to make healthy food decisions that can impact their cancer outcomes.

PRIMARY OBJECTIVE:

I. To describe the feasibility and acceptability of a group diet education intervention for colorectal cancer (CRC) survivors at Zuckerberg San Francisco General Hospital (ZSFGH).

SECONDARY OBJECTIVE:

I. To describe perceived barriers to healthy diet among CRC survivors at ZSFGH.

EXPLORATORY OBJECTIVES:

I. To evaluate for differences in feasibility and acceptability of a group diet education program, based on sociodemographic factors such as education, food insecurity, employment, and race.

II. To explore changes in health-related behaviors pre and post intervention using a validated lifestyle score.

OUTLINE:

Patients attend group diet education sessions over 1.5-2 hours every 2 weeks (weeks 1, 3, and 5).

After completion of study, patients are followed up at 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Able to speak and read English or Spanish
* Diagnosed with stage 1- 4 colorectal cancer within 5 years prior to study enrollment and treated with curative intent
* Receiving survivorship follow up care at Zuckerberg San Francisco General Hospital (ZSFGH)
* Able to provide written consent

Exclusion Criteria:

* Currently receiving chemotherapy, biologic therapy, radiation, or immunotherapy for colorectal cancer
Hip Muscle Strength in FAI Versus Normal Controls

Hip Muscle Strength in femoro-acetabular impingement participants versus normal controls.

To investigate the hip muscle strength in a normal control group and compare this to patients who have a diagnosis of femoro-acetabular impingement (diagnosed clinically and with confirmed radiological features).


Eligibility Criteria:
Inclusion Criteria:

* Males and Females.
* Aged 18-30.
* Control group - Normal range of movement and no evidence of femoro-acetabular impingement on clinical examination (negative impingement test, no symptoms).
* Participants with femoro-acetabular impingement as diagnosed clinically and on radiological imaging for the comparison group (MRI).

Exclusion Criteria:

* Patients under the age of 18.
* Patients over the age of 30.
* Control group - evidence of underlying pathology affecting the hip, abnormal range of motion, evidence of femoro-acetabular impingement on clinical examination.
* Previous surgery of the hip joints.
* Medical history of arthritis (including rheumatoid and reactive).
* Family history of femoro-acetabular impingement (control arm participants).
* Patients who are currently experiencing or have experienced hip pain in the previous 1 year (control arm).
* Other conditions (e.g. neurological, muscular dystrophy etc) which may affect hip muscle strength.
Assessment of DeMentia Nutrition Intervention Needs Among Care Recipients and carEgivers

Nutrition is critical for disease prevention and brain health. Malnutrition and weight loss often affect persons with Alzheimer's dementia (PWD), worsening overall health and dementia. Informal caregivers (usually family members) perform many nutrition-related tasks as part of daily care such as food preparation and feeding. Limited research, however, suggests informal caregivers experience high rates of caregiver burden, malnutrition and low health literacy. More research is needed to uncover these and other factors that may contribute to malnutrition for both PWDs and their caregivers. Nutrition literacy, or ability to navigate nutrition information to select healthy food, may be an important caregiving factor that protects both individuals from experiencing nutritional decline. Although the NIH has increased funding to support caregiver research, caregiver interventions that include nutrition are lacking. The purpose of this study is to inform the design of a future nutrition intervention study.


Eligibility Criteria:
Inclusion Criteria:

* Person with dementia: Must be an adult of any age, diagnosed with Alzheimer's dementia or other dementia, reside at home with a family caregiver or domestic partner, and have weight records at a minimum of 2 timepoints.
* Caregiver: Must be at least 18 years old, English speaking, primary caregiver who is responsible for food planning, and no overt cognitive impairment.

Exclusion Criteria:

* Person with dementia: Frontal-temporal dementia, alcohol-related dementia, Huntington's disease, schizophrenia, manic-depressive disorder, or actively participating in nutrition intervention research.
* Caregiver: Visual impairments that prevent completing questionnaires or actively participating in nutrition intervention research.
Landmark Versus Ultrasongraphy Guided Spinal Anesthesia in Lower Abdominal Surgeries in Cancer Patients: a Randomized Controlled Trial

Spinal anesthesia is a commonly employed technique for lower abdominal surgeries, providing effective anesthesia and analgesia with minimal systemic effects. In cancer patients undergoing such procedures, careful consideration of anesthetic techniques is crucial, given their often-compromised physiological state and the need to minimize postoperative complications. Two approaches to administering spinal anesthesia are Ultrasound (US)-guided and the traditional landmark-based technique.

the aim of the study :To evaluate the efficacy, safety and feasibility of US-guided spinal anesthesia versus the landmark-based technique in cancer patients undergoing lower abdominal surgery.

The traditional landmark method relies on palpating anatomical structures, such as the iliac crests and spinal processes, to guide needle insertion. Although widely used, it can be challenging in patients with anatomical variations, obesity, or previous surgeries, potentially leading to multiple attempts, increased patient discomfort, or complications. On the other hand, Ultrasound (US) imaging has become an increasingly popular tool among anesthesiologists to guide neuraxial blockade. US-guided spinal anesthesia provides real-time visualization of the relevant anatomy, including the spinal canal, ligaments, and surrounding tissues, enabling more accurate needle placement. This technique has gained attention for its potential to improve success rates, reduce complications, and enhance patient comfort, particularly in complex cases such as cancer patients, where precision is vital.

By examining factors such as procedural success rates, patient comfort, complication rates, and overall outcomes, we can better understand the role of ultrasound guidance in optimizing anesthetic care for this vulnerable patient population.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* Both sex
* patients with a body mass index (BMI) of 18-40 kg/m2
* American Society of Anesthesiologists (ASA) physical status classification of I to III.

Exclusion Criteria:

* • Patients have a contraindication for regional anesthesia, e.g. coagulopathy.

  * Failed or unsatisfactory intrathecal block.
  * Patients with known hypersensitivity to amide local anesthetics.
  * Local injection site infection or spinal deformity.
  * Severe hypotension.
  * Space occupying lesions of the brain.
  * Hypovolemia.
  * Pregnancy.