cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy.

This is a multicenter, open-label, nonrandomized, Phase 2 umbrella study of retifanlimab in participants who have advanced or metastatic endometrial cancer that has progressed on or after platinum-based chemotherapy. retifanlimab will be administered as monotherapy or in combination with other immunotherapy or targeted agents.


Eligibility Criteria:
Inclusion Criteria:

* Ability to comprehend and willingness to sign a written ICF for the study. Note for Germany: This excludes individuals who are housed in an institution due to official or court order Women 18 years of age or older (or as applicable per local country requirements).
* Histologically confirmed diagnosis of advanced or metastatic endometrial cancer with disease progression on or after treatment with at least 1 platinum-containing regimen for advanced or metastatic disease.
* Groups A, B, and E: Have not been previously treated with a PD-(L)1 inhibitor.
* Group A only: Tumor tissue tested as MSI-High
* Group B only: Tumor tissue tested as deficient MMR or an ultra-mutated POLE tumor.
* Group D only: Tumor tissue tested as having an FGFR 1,2,3 mutation or alteration characterized as per protocol.
* Group E: Tumor tissue tested as MSS and PD-L1 positive.
* Group F: Radiological evidence of disease progression on or after prior PD (L)1 therapy and Tumor tissue tested as MSI-H
* Must have at least 1 measurable tumor lesion per RECIST v1.1.
* Willing to provide tumor tissue sample (fresh or archived).
* ECOG performance status 0 to 1.
* Willingness to avoid pregnancy.

Exclusion Criteria:

* Group A, B and E only: Histologically confirmed diagnosis of carcinosarcoma of the uterus.
* Histologically confirmed diagnosis of sarcoma of the uterus.
* Has disease eligible for potentially curative treatment.
* Receipt of anticancer therapy within 28 days of the first administration of study treatment, with the exception of localized radiotherapy.
* Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline unless approved by the medical monitor.
* Groups C, D and F (combinations): limiting immune-related toxicity during prior checkpoint inhibitor therapy.
* Group F only: Previous treatment with LAG-# or TIM-3 therapy or lenvatinib; multiple metastases that achieved mixed tumor response to prior anti-PD-(L)1 therapy
* Has an active autoimmune disease requiring systemic immunosuppression with corticosteroids (\> 10 mg/day of prednisone or equivalent) or immunosuppressive drugs within 14 days before the first dose of study treatment.
* Receiving chronic systemic steroids (\> 10 mg/day of prednisone or equivalent):
* Known active CNS metastases and/or carcinomatous meningitis.
* Has known active hepatitis B or C.
* Has received a live vaccine within 28 days of the planned start of study treatment.
* Evidence of interstitial lung disease or active, noninfectious pneumonitis.
* Participants who are known to be HIV-positive with some protocol exceptions.
Epidemiologic Multicenter Prospective Study in Advanced NSCLC (Non Small Cell Lung Cancer) Patients With PDL1 (Protein Death Ligand 1) Expression.

Epidemiologic multicenter prospective study in advanced NSCLC patients with PDL1 expression : evaluation of clinical and pathological characteristics of PDL1 high expression patients compared to patients with a weak or no expression of PDL1.

Few data are published on the clinical and pathological characteristics of advanced NSCLC with high PDL1 expression compare to weak and no expression populations.

There is not for the moment a standard test to determine a relevant target population. Preliminary data showed that around 25% of the NSCLC population may have a high PDL1 expression and may have a greater benefit of anti PDL1 therapy. But in fact limited data have been published in European populations on the clinical and pathological characteristics (high PDL1 expression) compared to the weak expression and no expression populations. More over the prognosis rule of a high PDL1 expression in NSCLC is not definitive, with some studies indicating it is a positive prognostic factor while other studies showing that it is a negative prognostic factor.

To understand if there are differences in terms of prognostic between advanced NSCLC with high and low/no expression of PDL1 is a major challenge for the future management strategy of these patients. The results of this study should helps to elaborate new guidelines for this population. Therefore is also important to had data's on the natural course of the disease in these population for building cost effectiveness models of new immune therapies.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or more

  * With locally advanced stage (IIIb) to stage IV NSCLC - Non Small Cell Lung Cancer -
  * Histological diagnostic :
* No known Epidermal Growth Factor Receptor (EGFR) or Anaplastic Lymphoma Kinase (ALK) / Reactive Oxygen Species (ROS) translocation
* At least 2 slides of tumoral sample available

  * No previous chemotherapy treatment. Neo or adjuvant therapy is allowed if done at least one year before inclusion
  * Performance Status ( PS) 0/1

Planned to receive a platin based standard treatment (cisplatin or carboplatin with bevacizumab (restricted to no squamous) pemetrexed(restricted to no squamous) , gemcitabine, vinorelbine, docetaxel or taxol, on first line setting, in standard dose

• A RECIST - Response Evaluation Criteria In Solid Tumor - target lesion

Exclusion Criteria:

* Age fewer than 18
* Pregnancy
* Known immune deficit
* PS \> 1
* Inclusion in a clinical therapeutic trial in first line
* Patient treated with Protein D1/Protein Death Ligang1 (PD1/PDL1) therapy on first line setting.
Relationship Between STOP BANG Score and Airway Management

Nowadays, anesthetists may encounter many patients who are not diagnosed with obstructive sleep apnea syndrome (OSAS) to undergo elective surgery. Recognition of these patients by anesthesiologists and taking necessary precautions will significantly reduce perioperative complications and mortality. STOP-BANG is a questionnaire used to predict high risk of OSAS. The aim of our study is to evaluate the clinical use of the oxygen reserve index as an early warning of possible desaturation in patients with low and high risk of OSAS according to the Stop Bang score.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I-III
* Between 18-65 years old
* Volunteered to participate in the study

Exclusion Criteria:

* diagnosed with asthma, COPD, heart failure or coronary artery disease, OSAS
* morbidly obese (BMI\>45 kg/m2),
* patients with a history of alcohol or drug addiction
* women in pregnancy or lactation
* allergic to the drugs used in the study
The Edmonton Symptom Assessment System (ESAS) as a Screening Tool for Depression in Cancer Pain Patients

Compare Thai versions of the Edmonton Symptom Assessment System (ESAS) and the Hospiral Anxiety and Depression Scale (HADS) with Diagnostic and Statistical Manual (DSM-5), as a screening tool for depression in cancer pain patients


Eligibility Criteria:
Inclusion Criteria:

* Cancer patients who follow up as out patient at pain clinic, Siriraj hospital
* Age older than 18 years old
* Fluently read, write and speak in Thai language
* No cognitive impairment

Exclusion Criteria:

* Unstable clinical presentation
* Severe pain or pain numerical rating scale more than 7
* Severe associated symptoms such as nausea, vomiting
* The patient who do not know their diagnosis
Skeletal Muscle Perfusion With LVAD

Advanced heart failure (when the heart pump fails) is associated with symptoms such as shortness of breath and extreme fatigue. Some of these symptoms are simply due to failure of the pump, however abnormal regulation of blood flow to the muscles of the body is also a potential mechanism. Left ventricular assist devices are mechanical pumps used to compensate for patients with failing hearts either as a bridge to heart transplant or as long term therapy. Whether or not these pumps improve muscle flow and whether this is a determinant in the improvement of symptoms is unknown. Understanding how skeletal muscle and heart perfusion is altered in heart failure patients before and after implantation of an LVAD could provide further insight into the beneficial effects of this therapy.

Specific Aims:

1. To evaluate skeletal muscle and heart perfusion studies before and after LVAD implantation
2. To compare functional status with degree of skeletal muscle perfusion.

Methods:

Thirty patients deemed to be candidates for LVAD from either outpatient heart failure clinic or inpatient cardiology service will be studies. Skeletal muscle perfusion imaging using standard of care ultrasound technology will be performed prior to LVAD implant and then 3 months post implant. Functional status by six minute walk test and specialized stress test will be assessed at 3 months post implant.

Eligibility Criteria:
Inclusion Criteria:

* patients deemed to be candidates for a LVAD

Exclusion Criteria:

* severe peripheral artery disease
* skeletal muscle disorder
* severe congenital heart disease
* pregnancy
* patients \<18 yo
Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring

Allergy prevalence is increasing steadily with some describing as the "epidemic of the twenty-first century". Maternal diet during pregnancy has been linked to offspring allergy risk, so it represents a potential target for allergy prevention. The Mediterranean Diet (MD) is considered one of the healthiest dietary models which exerts regulatory effects on immune system, due to the synergistic and interactive combinations of nutrients. We aim to study the effects of MD in pregnancy on the onset of allergic diseases at 2 years of age in the offspring.


Eligibility Criteria:
Inclusion Criteria:

- healthy women (aged 20-35 years), at first trimester of pregnancy, of at risk for atopy baby

Exclusion Criteria:

* concomitant presence of infections;
* concomitant presence of malignancies;
* concomitant presence of major gastrointestinal malformations;
* concomitant presence of immunodeficiencies;
* concomitant presence of autoimmune diseases;
* concomitant presence of chronic inflammatory bowel diseases;
* concomitant presence of functional gastrointestinal disorders;
* concomitant presence of celiac disease;
* history of abdominal surgery with gastrointestinal resection;
* concomitant presence of neuropsychiatric disorders;
* concomitant presence of central nervous system disorders;
* vegan diet;
* twin pregnancy;
* concomitant presence of genetic disorders;
* concomitant presence of metabolic disorders.
Preventing Cognitive Decline

The study aims to understand the mechanisms and training effects of evidence-based body-mind training on improving cognitive performance and preventing cognitive decline.

Subjective cognitive decline (SCD), the self-reported perception of memory or cognitive problems, is a risk factor for the cognitive decline and development of Alzheimer's (AD) and often happens in midlife. Recently, few mind-body interventions have suggested promising effects in preventing cognitive decline. However, these interventions often require longer training time (months to years) to achieve modest benefits, making them less optimal for rapidly learning and achieving desirable outcomes. One mechanism for cognitive decline and AD may involve deficits in self-control networks, and autonomic nervous system (ANS) and these deficits can be ameliorated through body-mind interventions. This study aims to investigate the modulation effects of a novel body-mind intervention on SCD using an evidence-based preventive intervention - integrative body-mind training (IBMT).

Eligibility Criteria:
Inclusion Criteria:

* Able to read/understand English
* Normal performance using standardized cognitive tests
* Self-reported decline in cognitive capacity such as memory loss
* Eligible for non-invasive fMRI
* Willing to be randomized
* Free of any severe psychiatric diagnoses or medication that may affect participation

Exclusion Criteria:

* Medical disorders or medications that affect the central and autonomic nervous system; or a positive pregnancy test result (females)
* Unable to provide consent or understand study procedures due to mental illness or cognitive limitations
* Previous meditation experiences
* Evidence of illicit drug use
* Participants for blood draws weigh less than 110 lbs
* Metal or metallic materials in the body such as pacemaker
Correlation of Electroencephalogram With Postoperative Delirium During Cardiac Surgery

The purpose of this study is to explore characteristic changes of EEG epileptiform discharges in patients under CPB and correlation with POD

Cardiac surgery under cardiopulmonary bypass (CPB) as a result of the surgery itself great trauma and CPB this special process can lead to cerebral hypoperfusion, cerebral ischemia, increased in patients with postoperative neurological complications, the incidence of postoperative cognitive dysfunction can up to 44-53%.Postoperative delirium (POD) is not only increase the incidence of postoperative cognitive dysfunction forward, affect the quality of postoperative recovery and increased hospital costs, also associated with postoperative mortality. Although the clinical use of different drugs and technology improve the POD, but due to the mechanism is still unclear, is still lack of effective control measures. Electroencephalogram (EEG) can measure the cerebral cortex and subcortical local potential activities, to reflect the activities of the neurons in the brain. CPB can cause the abnormal vibration of brain waves, epileptiform discharges is the result of abnormal discharge of brain neurons, which is correlated with the occurrence of cognitive dysfunction.But whether EEG epileptiform discharges is related to the POD is uncertain.While epileptic seizures can be treated with anticonvulsant drugs, so the detection and treatment of early epileptic seizures may have important clinical significance for the occurrence of POD. Therefore, the main purpose of this study is to explore characteristic changes of EEG epileptiform discharges in patients under CPB and correlation with POD, offer the theoretical foundation for delirium early warning and prevention.

Eligibility Criteria:
Inclusion Criteria:

1. ASA II-III;
2. No cognitive impairment was assessed one day before surgery;
3. Patients undergoing elective CPB cardiac surgery(valvular heart surgery and coronary bypass surgery) and signed informed consent.

Exclusion Criteria:

1. Non-CPB surgery, macrovascular surgery, heart transplantation, correction of congenital heart disease;
2. Stroke, schizophrenia, depression, Parkinson's disease, epilepsy or dementia;
3. Inability to communicate with language impairment or major hearing or visual impairment;
4. Liver function child-pugh Grade C, severe liver dysfunction;
5. Severe renal insufficiency requires preoperative renal replacement therapy;
6. A past history of intraoperative knowledge.
SKED Physiology Study

A SKED© is a stretcher typically used for for confined space, high angle, or technical rescue. SKED© is not an acronym; the word came from fusing two words: "Sled" and "Skid." Over the last several years, as recommendations for spinal protection and utilization of adjunct field hardware for patient application changes, there have been conflicting training and practice regarding optimizing patient packaging utilizing the SKED© system. Specifically, there is disagreement in terms of optimal packaging to ensure no decompensation of respiratory status of the patient objectively, as well as comfort level subjectively solely related to the packaging method utilized. Several training bodies currently employ different practices of packaging including use of an Oregon Spine Splint-II© (OSS-II) system within a SKED©, foam padding, vacuum mattress configuration, or even no additional adjunct at all. The objective of this study is to determine whether adjuncts to the SKED© system impact respiratory physiology, or patient comfort while being dragged over horizontal ground.

This study will be a randomized controlled, non-blinded trial The setting of this study will be an area of level ground, outdoors at a state park. Study enrollment goal is 50 subjects. This was determined by review of statistics from similar studies, available funding and time frame allocated to complete the study. There is not planned interim analysis, and no criteria for ending the study early. Each participant will be packaged using a SKED© system with no assumed spinal injury. Each subject will be packaged with SKED© only; SKED©+OSS-II©; SKED©+Vacuum mattress; SKED©+foam padding. Each patient packaged within their respective systems as one unit will be subject to a 30 meter controlled drag over terrain chosen to mimic a standard dry backcountry extrication drag. Then carried back to the start by a 4 person carry team to simulate a carry out scenario. The same 30 meter ground area will be used for all systems. Built in safety during the drag includes a manually monitored electric winch system with load cells and two safety operators walking alongside the packaged patient. Target movement will be approximately 1.5-2 miles per hour.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* Pregnant females
* Incarcerated individuals
* Anyone with difficulty with enclosed or restrictive spaces
* Subjects with a history of lung disease such as Chronic obstructive pulmonary disease (COPD) or asthma
Chemotherapy Decisions and Outcomes in Older Women With Newly Diagnosed Breast Cancer

RATIONALE: Studying how older women make treatment decisions and how these decisions affect the outcome of treatment may help doctors plan more effective treatments and improve patient quality of life.

PURPOSE: This clinical trial is studying how a patient's treatment preferences and decisions about chemotherapy affect the outcome of treatment in older women with newly diagnosed breast cancer.

OBJECTIVES:

* Determine the relationship between preferences and chemotherapy decisions in women age 65 and over with operable, newly diagnosed breast cancer.
* Determine how factors that could be targets for intervention affect the relationship between preferences and chemotherapy decisions in these patients.
* Determine the relationships between preference-based chemotherapy decisions, quality of life, and satisfaction with treatment decisions in these patients.
* Determine the disease-free survival and competing causes of mortality of these patients.
* Determine the types of physician providers who care for older breast cancer survivors after initial cancer treatment is completed and explore how women decide about which physicians to see.
* Measure quality indicators for the survivorship phase of care and evaluate if quality varies by type of physician provider model.
* Determine if long-term patient-reported satisfaction varies as a function of physician model for providing follow-up care post-treatment.
* Determine whether physician-patient communication and coordination of care after treatment ends mediate follow-up quality and outcomes post-treatment.

OUTLINE: This is a cohort study.

Patients participate in interviews over 30-45 minutes at baseline, at 6 months, and at 1 and 2 years.

Patients are followed annually for at least 5 years.

PROJECTED ACCRUAL: A total of 1,296 patients will be accrued for this study within 18-24 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed primary adenocarcinoma of the breast

  * Operable disease
  * Invasive and unilateral tumor
  * No more than 20 weeks since diagnosis
  * T1-4 (tumor size ≥ 1 cm), N0, M0 OR
  * T1-4, N1-3, M0
* No prior carcinoma in situ, lobular carcinoma in situ, ductal carcinoma in situ, or invasive breast cancer
* Hormone receptor status:

  * Any estrogen receptor status

PATIENT CHARACTERISTICS:

Age

* 65 and over

Sex

* Female

Other

* No other malignancy except those for which the patient has completed treatment AND is considered to be at less than 30% risk of recurrence
* History of non-melanoma skin cancer allowed
* Sufficient cognitive function to consent to and complete interviews
* English or Spanish speaking
Effectiveness of Pressure Biofeedback Therapy and Progressive Muscle Relaxation Technique in Improving Pain and Disability Among Patients With Non-Specific Low Back Pain

Low back pain is common MSK disease with prevalence of 60 to 70 percent. Patients with low back discomfort are typically treated conservatively by physical therapists. Progressive muscles relaxation technique has been shown in several studies to reduce chronic back pain and increase flexibility. pressure biofeedback therapy works on Intra abdominal pressure.it helps to alleviate compression on lumbar spine and support the adjacent lumbar spine.The aim of this randomized controlled trial is to determine the effectiveness of pressure biofeedback training (Pr.BFB) in combination with progressive muscles relaxation technique (PMR) \& progressive muscles relaxation training alone on pain, disability, ROM \& endurance of muscles among nonspecific chronic low back pain patients.

A randomized clinical trial will be carried out in the Physical Therapy O.P.D of Dow hospital Karachi. Collection of data will commence right after approval of synopsis from Dow IRB. A sample of 70 NSCLBP patients calculated by using mean \& SD of visual analogue scale in abdominal stabilisation training with Pr.BFB stabilizer was 2.69 ±0.93 and Progressive muscular Relaxation VAS was 3.863 ±2.03. Before being recruited into the experiment, patients will be screened to ensure that they meet the inclusion criteria. Pain rating scale and Roland-Morris questionnaire will be used to gather data after explaining the research goals to patients and obtaining formal consent from them. Patients will be divided into 2 interventional groups by simple random sampling, with 35 patients in each group. Experimental group will be received Pressure Bio-Feedback Therapy in combination with PMR Technique and Thermotherapy. The Control group, on the other hand, will be received a combination of Progressive Muscle Relaxation Technique and Thermotherapy for non-specific CLBP. It will be a 6-weeks intervention plan with 3 sessions per week (40-minutes each). Assessor will be blinded to the treatment. Roland Morris Low back pain and disability questionnaire (RMQ) and the NPR Scale will be used as primary outcome measures. Secondary outcomes will be determined by modified-modified Schober test for assessing lumbar ROM \& Pressure Biofeedback Stabilizer unit helps to gauge muscular endurance.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed and referred patients with non-specific low back pain for more than 3 months
* 30 to 50 years
* Both genders

Exclusion Criteria:

* Any surgical history of lumbar spine
* Infections of the spine, malignancy
* Disc protrusion
* History of spinal fractures