cyrilzakka/clinical-trials huggingface dataset:
Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors

The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate the effect of XmAb541 on tumor outcomes.


Eligibility Criteria:
Key Inclusion Criteria:

* Age ≥ 18 years. For subjects with GCTs, age ≥15 years
* CLDN6+ tumor
* Histological or cytological documentation of locally advanced, recurrent, or metastatic ovarian, fallopian tube, or peritoneal cancer, adenocarcinoma of the endometrium (endometrial cancer, uterine cancer, or carcinoma of the uterine corpus), GCT
* Have documented progressive disease (PD) on standard-of-care therapies appropriate for the specific tumor type; have exhausted therapies with a survival benefit or the standard therapy has no survival benefit or proven to be ineffective, intolerable, or subject is not a candidate for such available therapy.
* Eastern Cooperative Oncology Group performance status of 0-2
* Life expectancy ≥ 3 months
* Adequate liver, kidney, and bone marrow function

Key Exclusion Criteria:

* Prior exposure to a CLDN6 targeting product
* Ovarian cancer that is platinum refractory, or has rapid progression on most recent prior ≥ second line systemic anticancer therapy
* Have known active central nervous system metastases and/or carcinomatous meningitis. Patients with treated brain metastases may participate, provided they are radiologically stable.
* Active known or suspected autoimmune disease
* Have any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug
* Clinically significant cardiovascular, pulmonary or gastrointestinal disease
* Positive test for hepatitis C RNA
* Positive test for hepatitis B surface antigen or hepatitis B core antibody (hBcAb)
Psychoeducation in Patients Who Diagnosed With Schizophrenia

People with schizophrenia are faced with social problems such as repeated hospitalizations, stigma with lack of social skills, unemployment, lack of necessary and adequate health care and education due to lack of adequate care in the community they live in. It is known that psychoeducation practices aimed at developing social skills in schizophrenia give patients new skills and these skills continue for many years. This study aimed to determine the effect of group psychoeducation that focused on social skill development on treatment adaptation, quality of life and well-being in schizophrenia patients and the interaction between these variables over time.

The aim is to determine the effect of group psychoeducation that focused on social skill development on treatment adaptation, quality of life and well-being in schizophrenia patients and the interaction between these variables over time.

The study was conducted with 42 schizophrenia patients (n=21 intervention group; n=21 control group) using a quasi-experimental research design. Patients were evaluated using a pre-test, post-test, monitoring test, "Medication Adherence Rating Scale (MARS)", "Quality of Life Scale for Schizophrenia (QLSS)" and "Flourishing Scale" (FS). The measurements were taken 3 times: pre test, post-test and 3-months post-test.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering
* Being 18 and over being literate
* Having been diagnosed with schizophrenia for at least three months
* Taking oral antipsychotics
* Being in remission.

Exclusion Criteria:

* Being in an acute period of exacerbation
* Actively using alcohol or psychoactive substances
* Having mental retardation or dementia
* Having another psychiatric illness that makes it impossible to cooperate.
Intrapulmonary Pharmacokinetics of Antibiotics

The major objectives of this research are to see how much, and for how long, telithromycin and azithromycin get into the fluids and cells of the lung.

The primary objective of this descriptive study is to determine and compare the plasma, epithelial lining fluid (ELF), and alveolar macrophage (AM) concentrations following multiple oral doses of telithromycin and azithromycin in healthy, non-smoking adult subjects.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 55 years, inclusive, of age
* No history of smoking within the last 1 year
* Body weight within +/- 15% of the Metropolitan Life Insurance Company tables
* No clinically important abnormalities in the medical history or physical exam
* Female subjects of childbearing potential must have a negative pregnancy test
* Female subjects of childbearing potential must use reliable methods of birth control

Exclusion Criteria:

* Allergy to telithromycin, azithromycin, or any macrolide antibiotic
* Allergy or serious adverse reactions to benzodiazepines or lidocaine
* History of renal, gastrointestinal, or liver disease
* Significant hypertension
* Clinically significant heart or pulmonary diseases
* History of drug or alcohol dependence within 12 months of study entry
* Positive pregnancy test
* Currently breast feeding
* Use of any drug within 2 weeks of study entry
* Received an investigational drug within 30 days of study entry
Ultrasound Shear Wave Elastography Evaluation of Suspected and Known Biliary Atresia

The investigators plan to investigate the use of US shear wave elastography (SWE), a newly available imaging technology, in children with suspected/known BA.

The investigators plan a prospective, multi-center study to determine if liver ultrasound shear wave speed measurements acquired at clinical presentation can discriminate biliary atresia (BA) from other causes of liver disease in the setting of neonatal cholestasis. The investigators also plan to determine if liver ultrasound shear wave speed measurements acquired at clinical presentation or longitudinally during the first one-year period after Kasai can predict important long-term outcomes in BA patients.

Eligibility Criteria:
Inclusion Criteria:

* neonatal cholestasis with concern for BA vs. other liver disease direct bilirubin \>20% of total or ≥2 mg/dL age \<3 months

Exclusion Criteria:

* inability to obtain parent/guardian consent.
* inability to return for follow up visits as required by the study (these patients will be included in aim 1, but will be unable to participate in aim 2).
* no other exclusion criteria.
Meteorin-like Levels in Individuals With Periodontitis

Metrnl has proven to be an inflammatory-related immunoregulatory cytokine and shown to play a role in the pathogenesis of human inflammatory diseases. Metrnl is highly expressed from the oral mucosa to the esophagus. Periodontitis is a chronic inflammatory disease that can start with localized inflammatory reactions created by the supporting tissues surrounding the teeth against microorganisms and then result in loss of teeth. The authors think that Metrnl may play a role in the periodontitis. The aim of this study is to compare the Metrnl, IL-1β, and IL-10 levels of healthy and periodontitis individuals.

Periodontitis is a destructive chronic inflammatory disease that can start with localized inflammatory reactions created by the supporting tissues surrounding the teeth against microorganisms and then result in loss of teeth. Cytokines play an important role in inflammation that occurs in periodontal disease.

Interleukine -1β ( IL-1β ) levels are associated with periodontal destruction in the pathogenesis of periodontal disease. Cytokines such as Interleukine-10 (IL-10) and transforming growth factor- β (TGF-β) have been reported to decrease periodontal disease progression rate.

Gingival crevicular fluid shows the cellular response in the periodontium. The most important host-related ingredients are inflammatory markers, including cytokines, enzymes, and interleukins. Saliva analysis is used in the diagnosis of systemic conditions as well as in the diagnosis of oral pathologies.

Meteorin- like (Metrnl) is a protein that plays a role in natural and acquired immune-related functions and inflammatory responses, and expressed in barrier tissues (skin and mucosa) as well as various macrophage populations, from dendritic cells and some granulocytes. Metrnl has proven to be an inflammatory-related immunoregulatory cytokine and shown to play a role in the pathogenesis of human inflammatory diseases. Metrnl, which is highly expressed from the oral mucosa to the esophagus, may play a role in the onset of periodontitis and an effective marker in preventing the progression of destruction. We think that Metrnl plays an important role in periodontitis, an inflammatory disease. The aim of this study is to compare the Metrnl, IL-1β, and IL-10 levels of healthy and periodontitis individuals

Eligibility Criteria:
Inclusion Criteria:

* systemically healthy
* individuals who does not have a disease under treatment,
* individuals without regular systemic medication

Exclusion Criteria:

* smoking
* receiving periodontal treatment in the last 6 months
* pregnancy
* menopausal or menstrual period
Efficacy and Acceptability of a Monkeypox Curriculum for Disproportionately Impacted Communities

The study team will create an online module via the REDCap platform. The module will include around 5 videos and several infographics covering the topics of symptoms, transmission, prevention, vaccination, and treatment of the monkeypox virus. Surveys assessing the primary and secondary study endpoints will be given to participants before and after the module. The purpose of the study is to assess the efficacy and acceptability of an educational presentation on monkeypox in a cohort of individuals recruited from Rainbow Health and to secondarily assess participant risk perception, intention to vaccinate, and confidence in public health initiatives.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who are 18 years and older
* Individuals able to read and write in English

Exclusion Criteria:

* Unable to provide informed consent
Diaphragmatic Function in Stroke Patients.

* This study attempts to elucidate whether stroke patients with dysphagia have reduced diaphragm movement during voluntary coughing, and also during deep inspiration and expiration than stroke patients without dysphagia.
* This study will also compare various spirometric measurements with the diaphragmatic motions.

Stroke is a debilitating condition that can impair multiple functions, including swallowing. Stroke patients with dysphagia, are known to have reduced cough due to multiple mechanisms and this can impair their expectorate function. This can lead to accumulation of sputum and mucoid, ultimately resulting in aspiration pneumonia. Stroke patients, especially those with dysphagia, are also known to have expiratory muscle weakness and weak cough than healthy controls. Stroke patients are also known to have reduced diaphragm movement than healthy subjects. Sonography is a useful tool that can easily and reliability measure diaphragm movement. Whether stroke patients with dysphagia have reduced diaphragm movement than those without dysphagia and whether this affects voluntary cough have not been reported yet.

This study attempts to evaluate diaphragm movements during voluntary cough in stroke patients with dysphagia and determine whether this reduced diaphragm movement correlates to their peak flow meters during voluntary cough.

Eligibility Criteria:
Inclusion Criteria:

* Stroke patients with confirmed unilateral brain lesion
* Gross aspiration confirmed via FEES or VFSS that would require non oral feeding for group 1.
* No gross evidence of dysphagia that would require non oral feeding for group 2.
* No prior episode of stroke or dysphagia for the healthy control group.

Exclusion Criteria:

* Episode of acute pneumonia or pulmonary embolism at time of enrollment
* Previous history of chronic respiratory disorders or other systemic disorders that may affect respiratory function ( ex, rheumatoid arthritis, chronic renal disease, spinal cord injury)
* Stroke patients with multiple brain lesions
* Episode of Diaphragm weakness due to peripheral polyneuropathy or unilateral phrenic nerve palsy
* Previous episode of abdominal or thoracic surgery within one year of enrollment
* Concomitant diagnosis of myopathy, muscular dystrophy or other disorders that may affect respiratory muscles.
* Episode of rib fracture within one year of enrollment
* Chronic alcoholism
* Patient with previous diagnosis of dementia or with impaired cognitive function that may limit full participation at the evaluation.
Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine

Patient will receive lamotrigine vs. placebo with small sips of water. Lamotrigine reaches peak level 1-4 hours after oral administration.

1:1 randomization without stratification use web-based software (Redcap) before surgery. Allocation will be concealed from the patient, the nurse, the operating room team. Both patient and the operating room team will be blinded to the treatment allocation (double blind).

Standard preoperative care as per anesthesia care team. Patient will receive lamotrigine vs. placebo with small sips of water. Lamotrigine reaches peak level 1-4 hours after oral administration. Single dose lamotrigine is safe and is not associated with rash.

Standard intraoperative care as per the anesthesia care team. All patients will receive Ketamine 1 mg/kg at induction. Ketamine 5mcg/kg/min will be started at induction and stopped at the end of surgery.

Standard postoperative care as per PACU team. The psychologic side-effects will be measured using Brief Psychiatric Rating Scale (BPRS) using an online tool.

Research fellow will receive standardized training in administering BPRS from Dr. Amit Anand using structured material. Dr. Anand has used this training for other current research projects.

Eligibility Criteria:
Inclusion Criteria:

* 18 -65 Years of age
* Planned overnight hospital stay

Exclusion Criteria:

* Pregnant and planning to become pregnant
* No known History of seizure
* No known History of Schizophrenia
* No known History of unstable angina
* Patients taking Antiepileptic medications
* Known history of Lamotrigine intake in past.
* Any history of allergic reaction to lamotrigine in the past.
Chidamide Combined With R-GDP in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

The goal of this clinical trial is to evaluate therapeutic efficacy of Chidamide combined with R-GDP （rituximab/gemcitabine/dexamethasone/cisplatin）in treating Patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) not suitable for transplantation.

The treatment outcome of patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) are not satisfactory especially for those not suitable for transplantation. One of main reason is chemotherapy resistance. The investigators conducted this study to evaluate the efficacy of Chidamide combined with R-GDP(rituximab/gemcitabine/dexamethasone/cisplatin) in treating patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) not suitable for transplantation. Chidamide is a novel benzamide type of subtype-selective histone deacetylase (HDAC) inhibitor. It has been approved by China Food and Drug Administration (CFDA) for treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) in Chinese population. The investigators' pre-clinical data suggested that this agent might be also efficient in the treatment of relapsed/refractory B cell lymphoma. In this open-label, non-randomized, phase II study, the investigators aimed to observe the efficacy and safety of chidamide combined with R-GDP in patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) not suitable for transplantation.

Eligibility Criteria:
Inclusion Criteria:

1. Ages: 18-75 years old
2. Relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) previous treated with standard chemoimmunotherapy
3. Not willing or not suitable for hematopoietic stem cell transplantation (HSCT)
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) index \< 2
5. Informed consent available
6. Life expectancy of more than 3 months;
7. Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed on signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention.
8. Bone marrow function: ANC ≥ 1.5 × 109/L, PLT ≥ 100 × 109/L, Hb ≥ 80g/L;
9. Liver function: total bilirubin, ALT and AST were \<1.5 × UNL (the upper limit of normal value)
10. Renal function: Cr\<1.5 × UNL and creatinine clearance \> 50ml/min

Exclusion Criteria:

1. Prior history of treatment of HDAC inhibitor.
2. Plan of HSCT in the future
3. Significant pericardial effusion showed by chest CT scan
4. Prior history of other cancers except treated cervical or basal cell skin carcinoma, organ transplantation
5. Syphilis or human immunodeficiency virus (HIV) infection
6. Pregnant or lactating women
7. History of organ transplantation
8. Serious active infections (including hepatitis)
9. Serious neurological or psychiatric history, including dementia or epilepsy.

Termination criteria:

1. Withdrew consent
2. Researchers think it is necessary to terminate the study;
3. Disease progression or death;
4. Poor compliance
5. Subclinical or clinical cardiac toxicity;
6. Unable to continue treatment because of severe toxicity
A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer

PUMA-ALI-4201 is a Phase 2 study evaluating alisertib monotherapy in patients with pathologically-confirmed small cell lung cancer (SCLC) following progression on or after treatment with one platinum-based chemotherapy and anti-PD-L1 immunotherapy agent. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior lines of therapy. This study is intended to identify the biomarker-defined subgroup(s) that may benefit most from alisertib treatment and to evaluate the efficacy, safety, and pharmacokinetics of alisertib.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years at signing of informed consent
* Pathologically confirmed SCLC
* Prior treatment with one platinum-based chemotherapy and an anti-PD-L1 immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior lines of therapy

Exclusion Criteria:

* Prior treatment with an AURKA specific-targeted or pan-Aurora-targeted agent, including alisertib in any setting

Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding

This is a Phase 4 observational study designed to assess the impact of Palynziq ® (pegvaliase) treatment in pregnant women with PKU and on their offspring who were exposed to pegvaliase at any time during pregnancy and breastfeeding.

Women prescribed pegvaliase by their healthcare provider (HCP) who become pregnant during treatment may decide to participate in the study and enroll via a centralized call center model. Upon consent, data will be collected from the patient's HCP(s) retrospectively for at least 3 months prior to Last Menstrual Period (LMP). Data will be collected during pregnancy and throughout the infant's first year of life. Pegvaliase exposure will be recorded during pregnancy and breastfeeding including exposure during each trimester of pregnancy. Duration of individual subject participation will be up to approximately 21 months.

Eligibility Criteria:
Inclusion Criteria:

* Subject (or a legally authorized representative) consent obtained prior to enrollment. Consent will be obtained in compliance with any country-specific regulations or requirements
* Confirmation of ongoing pregnancy. Subjects with unknown outcomes will be classified as prospective pregnancies; subjects who have undergone prenatal testing (eg, targeted ultrasound, amniocentesis) regardless of findings will be classified as retrospective pregnancies
* Diagnosed with PKU per local standard of care
* Documentation that the subject was treated with pegvaliase at any point starting from 2 weeks prior to the date of LMP
* Agrees to permit the Investigator (ie, CRP, CCA, PI) to contact the subject's HCPs (eg, PCP, PKU-treating physician, OB, nurse, midwife) and the infant's HCP (eg, pediatrician, neonatologist) for medical information

Exclusion Criteria:

• Currently participating in a BioMarin sponsored interventional study of any investigational product, device, or procedure
Bergamot and Cardio-Metabolic Risk Factors

Bergamot-derived products have shown significant effects on plasma lipids. We aim in the present study to evaluate the effect of bergamot on several cardio-metabolic risk markers.

The research hypothesis is to assess whether bergamot reduces plasma lipids (total cholesterol, triglycerides, low-density lipoprotein (LDL)-cholesterol and high-density lipoprotein (HDL)-cholesterol), atherogenic lipoproteins, carotid intima-media thickness (IMT) and liver steatosis in patients with dyslipidemia.

The primary objective is to assess whether bergamot reduces plasma lipids and atherogenic lipoproteins in patients with dyslipidemia.

Primary endpoint: Reduction in plasma lipids and atherogenic lipoproteins. The secondary objective is to assess whether bergamot reduces carotid intima-media thickness (IMT) and liver steatosis in patients with dyslipidemia.

Secondary endpoint: Reduction in IMT and and liver steatosis.

Clinical diagnostic tools will include the measurement of:

1. cIMT, that will be assessed by B-mode real-time ultrasound using a single sonographer (Medison SonoAce Pico, with a probe of 7.5-10.0 MHz) in a standardized manner with fixed angles of insonation;
2. liver steatosis, that will be assessed by by abdominal ultrasound.

Biochemical analyses will include the analysis of:

1. Routine testing of plasma lipids;
2. Atherogenic lipoproteins, e.g. the analysis of 11 distinct lipoproteins including very-low-density lipoprotein (VLDL), 3 intermediate density lipoprotein (IDL) subclasses and 7 low density lipoprotein (LDL) subclasses.

Eligibility Criteria:
Inclusion Criteria:

* elevated LDL-cholesterolemia

Exclusion Criteria:

* severe hepatic or renal diseases
Is Anxiety Affect the Anesthesia Type Performed In Patients During Caeserean Section ?

In this study, investigators wanted to investigate the effect of preoperative anxiety level on anesthesia preference of patient. Before surgery, patients will fill the forms of Pain catastrophising scale (PCS), Beck depression and Beck anxiety scale. After surgery, these forms will be evaluated according to the choice of anesthesia.

Anxiety is present due to many gait in the preoperative period. In studies that investigated anxiety levels in the preoperative period was found that 60-80% of the patients had significant anxiety. The present study is aimed to investigate the effect of preoperative anxiety level on anesthesia preference of cesarean patients. After approval, patients enrolled in the study is invited to complete the Pain Catastrophizing Scale questionnaire, Beck depression and Beck anxiety scale. After surgery, The effect of anxiety on the choice of anesthesia will be evaluated (general or spinal anesthesia).

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 40 years
* Planned to undergo ceserean
* An American Society of Anesthesiologists score of 1 or 2

Exclusion Criteria:

* Psychiatric diseases
* Rejected to participation