cyrilzakka/clinical-trials huggingface dataset:
The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-375

The purpose of this clinical trial is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-375 and D387 in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults aged 19 to 55 years
2. Females who are not pregnant or breastfeeding or who have surgical infertility
3. Signed informed consent form
4. Other inclusion criteria, as defined in the protocol

Exclusion Criteria:

1. History of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
2. Clinical laboratory test values are outside the accepted normal range at Screening
3. Current smokers or those who cannot quit smoking during the period from 90 days before the first IP dosing to the last discharge.
4. Subject who drink excessive caffeine or alcohol continuously and who cannot discontinue caffeine or alcohol intake during the period from 3 days before the first IP dosing to the last discharge.
5. Participated in a clinical trial within 90 days prior to 1st IP dosing
6. Not eligible to participate for the study at the discretion of Investigator
7. Other exclusive inclusion criteria, as defined in the protocol
Post-Hoc Enthusiasm and Wariness

The post-hoc fallacy (also termed the post-hoc-ergo-propter-hoc fallacy) has been recognized for centuries with endless relevance. The general concept in medical care is that patients who improve after a treatment are not necessary patients who improve because of a treatment. Modern medicine provides multiple opportunities to examine such pitfalls of judgment due to the prevailing uncertainty, incompleteness of our understanding pathogenic mechanisms, and natural tendency to connect treatments to outcomes. In this study, we will investigate whether judgments about vitamin supplementation might demonstrate the post-hoc fallacy.

We plan to conduct a brief survey of pharmacies portraying a patient in two slightly different versions. One version will portray the patient who feels better after starting a vitamin supplement whereas another version will portray the patient who feels unchanged after starting a vitamin supplement. The patients will be randomly assigned to participants and otherwise contain identical information. Judgments will be measured by eliciting participants recommendation about continuing the vitamin (Appendix_Script).

Eligibility Criteria:
Inclusion Criteria:

* Community pharmacist

Exclusion Criteria:

* Outside Ontario
Safety Study of Imexon Plus Docetaxel in Lung, Breast or Prostate Cancer Patients

Protocol AMP-010 is a Phase 1b study of imexon plus docetaxel for patients with previously treated breast cancer, previously treated lung cancer or hormone refractory prostate cancer. Docetaxel is approved by the Food and Drug Administration (FDA) as a second line therapy for these cancers. The imexon is administered on days 1-5 and the docetaxel on day 1 of every 3 week cycle. The objective of the protocol is to determine the highest dose of imexon which can be given with a full dose of docetaxel, and to provide information to enable the design of a future study focused on one or more specific cancer types.


Eligibility Criteria:
Inclusion Criteria:

* Be diagnosed with previously treated breast, lung, or prostate cancer where docetaxel is indicated.
* Prior treatment; at least one prior regimen required.
* Able to perform the activities of daily living.
* Off prior cancer therapy for at least 4 weeks.
* If female neither pregnant nor nursing.
* Willing to use contraceptives to prevent pregnancy.
* No other serious illnesses.
* No other active malignancy.
* No serious infections.
* No other current drug therapy for the cancer.
* Blood counts and blood chemistries in or near normal range.
* Prior radiation is permitted.

Exclusion Criteria:

* Active brain metastases.
A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).

Pfizer MEVPRO-1 (C2321014) is a randomized, open-label, multi-center clinical trial evaluating whether combining the study medicine (PF-06821497) with enzalutamide is safe and effective compared to physician's choice of either second-line androgen receptor (AR) directed therapy with enzalutamide or docetaxel (chemotherapy) for treating metastatic castration-resistant prostate cancer (mCRPC) after progression on prior abiraterone acetate treatment.

The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of the combination of PF-06821497 plus enzalutamide versus physician's choice of enzalutamide or docetaxel.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
* Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
* Progressive disease in the setting of surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required.
* Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with life expectancy of at least 6 months as assessed by the investigator.

Exclusion Criteria:

* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may make the participant inappropriate for the study.
* Know history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery.
* Clinically significant cardiovascular disease.
* Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.
* Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy, radioligand therapy (i.e. 177Lu-PSMA-617, radium 223), androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment, with the following exceptions:

  1. Treatment with first-generation antiandrogen agents, if discontinued prior to first dose of study intervention.
  2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion.
* Previous administration with an investigational product within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is shorter).
* Inadequate organ function.
A Study of Cabiralzumab Given by Itself or With Nivolumab in Advanced Cancer or Cancer That Has Spread

The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, is safe and tolerable in the treatment of advanced malignancies.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Performance status 0-1
* Adequate organ function
* Cohort M1, 2 and C1: Measurable disease
* Cohort M1, M2 and C1: Subjects must have histologic or cytologic confirmation of an advanced (metastatic and/or unresectable) malignant solid tumor
* Cohort C2: Documented refractory or relapsed multiple myeloma
* Subjects must be refractory to or have relapsed after standard therapies, or have no known effective treatment

Exclusion Criteria:

* Cohort M1, M2, and C1: Untreated or active central nervous system (CNS) or leptomeningeal metastases
* Cohort M1, M2, and C1: Subjects with hepatocellular carcinoma (HCC)
* Cohort C2: Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia

Other protocol defined inclusion/exclusion criteria could apply
The Aim of This Research is to Better Understand How Complete Spinal Cord Injury May Change Erogenous Zones in Adult Males

A complete spinal cord injury (SCI) in men is characterized by the total loss of motor skills and sensations below the injury. The loss of penile sensation, the erogenous zone primarily involved in sexual response, is involved in sexual dysfunction, impacting sexual pleasure and quality of life. The management of genito-sexual dysfunction is a priority for paraplegic patients, ahead of bladder-sphincter and motor functions. For tetraplegic patients, the restoration of genito-sexual functions is their second priority after the upper limb motor skills recovery (Anderson, 2004)(Anderson et al., 2007). Medical assistance is currently available to i) restore erectile function allowing penetrative sexual intercourse, ii) enable sperm collection for reproductive purposes, iii) assisted reproductive techniques which allowing most often these patients to achieve their fatherhood goals (Giuliano et al., 2019)(Chochina et al., 2016)(Lombardi et al., 2015). Nevertheless, the assessment and management of the loss of genital sensations have been poorly studied, alike sexual pleasure and satisfaction in SCI patients (Philpott et al., 2006).

Erogenous zones are regions of the body that elicit sexual pleasure and trigger or enhance sexual arousal when appropriately stimulated. The discovery of other forms of physical intimacy that move away from the traditional scripts of phallo-centric male sexuality (Earle et al., 2020)(Giurleo et al., 2022)(Ostrander, 2009)(Burns et al., 2008) could improve sexual pleasure. The stimulation of hypersensitive regions in the skin areas corresponding to the lesion level and above has the potential to represent one of the strategies to compensate the lack of sensitivity of the genital-sexual organs (Hohmann, 1972)(Bach-y-Rita, 1999)(Elliott, 2002)(Anderson et al., 2007)(Lopez et al., 2008)(Alexander \& Marson, 2018). But again, these data are scares and limited to few testimonials.

The aim of the present research program is to identify, define and characterize erogenous zones in men with complete SCI in the absence of sensitivity of the genitals.

The study design is a qualitative observational study, and the consolidated criteria for reporting qualitative research (COREQ) will be followed (Tong et al., 2007). A minimum of fourteen semi-structured interviews with men with a complete SCI followed in a neuro-urology department will be conducted with the recruitment stopped once data saturation is achieved.


Eligibility Criteria:
Inclusion Criteria:

* Men
* Complete spinal cord injury
* Heterosexual
* Sexual activity prior to the injury

Exclusion Criteria:

* Syringomyelia
* Other neurological condition
* No sexual activity since the injury
Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases

Patients that have had staging studies identifying them as AJCC stage IV with up to five liver metastases will be considered for the study. About 60 patients will take part in this study at UT southwestern, Parkland Health \& Hospital System, and Methodist Richardson Cancer Center. There are four dose cohorts for this study and each cohort will enroll a minimum of 7 to a maximum of 15 patients depending on tolerance of therapy. The treatment period will last for approximately 1 day and the follow-up portion of the study will last 5 years.

If the patient has met all the eligibility criteria, they will be registered to the study After successful registration to the study and treatment planning session, patients will receive a single fraction of radiation. The total dose a particular patient receives will depend on the dose cohort they are enrolled into. Each treatment will last about one hour and will be given in a particular position to help guide the beams of radiation toward the cancer area. Although it is not mandatory, it is recommended that patients receive corticosteroid premedication (e.g. Decadron 4-10 m.g. p.o. in a single dose or equivalent) 15-60 minutes prior to each treatment for the intended purpose of modulating immediate acute inflammatory effects and providing anti-emetic support.

Eligibility Criteria:
Inclusion Criteria:

* Signed study specific informed consent form.
* Age ≥ 18.
* Zubrod Performance Status 0-2.
* Biopsy proven primary malignancy.
* Predicted survival of \>6 months.
* AJCC Stage IV disease with up to 5 liver metastases as seen on a contrast- enhanced CT, MRI or PET/CT.
* Ability to spare a critical liver volume as defined by the protocol constraints.
* Tumors must be located outside the Central Liver Zone defined by contouring the portal vein to its bifurcation + a 3-dimensional 2cm margin

Exclusion Criteria:

* Patients with a history of prior irradiation or other treatment to the liver or abdomen who after the protocol treatment would have cumulative doses to the liver or other normal tissues greater than the protocol defined constraints.
* Need or plans for concomitant antineoplastic therapy (including surgery, cryotherapy, radiofrequency ablation, chemo-embolization, conventionally fractionated radiotherapy, brachytherapy, and hepatic artery chemotherapy) for the protocol treated lesions except at progression. Adjuvant systemic therapy before and after the protocol therapy per section 7.0, and surgery or other ablative therapy is allowed for lesions appearing after enrollment to this protocol as per section 8.0 is allowed.
* Germ cell or hematologic malignancies.
* History of Crohn's Disease or Ulcerative Colitis.
* Active peptic ulcer disease.
* Underlying hepatic cirrhosis with Child-Pugh class B or C
* A major psychiatric illness which would limit understanding of the proposed protocol treatment and consent process
* Men and women of reproductive potential may not participate unless they agree to use an effective contraceptive method.
* Pregnant or lactating women.
* Severe, active co-morbidity
* Abnormal labs
Periodontal Infection and Endothelial Dysfunction

The purpose of this study is to determine the effect of periodontal therapy on endothelial function and other biomarkers of cardiovascular disease

Periodontitis is one of the most prevalent chronic diseases and a frequent cause of tooth loss. Accumulation of subgingival dental biofilm in susceptible individuals is associated with an inflammatory host response characterized by the production of Matrix Metalloproteinases, reduction in collagen synthesis, increase in cytokine gene expression, and apoptosis of gingival fibroblasts. Finally, inflammation leads to destruction of periodontal ligament, alveolar bone resorption, and chronic periodontitis.

Periodontitis is associated with increased serum levels of inflammatory cytokines and acute phase reactants. Multiple case-control and cohort studies have suggested that periodontitis is an independent risk factor for cardiovascular events, diabetic end-organ damage, pregnancy complications and respiratory diseases. Recent interventional studies have found that periodontal therapy could increase endothelium-dependent brachial artery flow-mediated dilation.

The purpose of this controlled clinical trial is to determine the effect of periodontal therapy on endothelial function in subjects with moderate to severe chronic periodontitis. Furthermore, the relationship between putative periodontal pathogens and endothelial function will be also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 25 years of age or older
* Three or more periodontal pockets with a probing depth (PD) \> 5mm
* Have at least 20 natural teeth
* Provide informed consent and willingness to cooperate with the study protocol

Exclusion Criteria:

* History of antibiotic use in the previous three months
* Pregnant or lactating females
* Treatment with antihypertensive, antilipemic, antiarrhythmic, and other cardiovascular drugs
* Systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic renal failure, tuberculosis, and autoimmune diseases
* Previous history of cardiovascular disease: Acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, atrioventricular block, peripheral vascular disease, cerebrovascular accident
* Patients who received periodontal treatment within the last 3 months
* Patients who require antibiotic prophylaxis before examination or treatment
* Patients with mental retardation and dementia
In Vivo Characterization of Macrophages in Pediatric Patients With Malignant Brain Tumors Using Ferumoxytol-enhanced MRI

This pilot early phase I trial studies how well ferumoxytol-enhanced magnetic resonance imaging (MRI) correlates with inflammatory (macrophage) responses in pediatric patients with malignant brain tumors. If there is good correlation, ferumoxytol-enhanced MRI can serve as a noninvasive imaging biomarker of inflammation.

PRIMARY OBJECTIVE:

I. To establish the magnetic resonance (MR) imaging signal characteristics of macrophages in pediatric patients (\>= 2 years old) with newly diagnosed malignant brain tumors using ferumoxytol, an ultrasmall superparamagnetic iron oxide (USPIO) particle.

SECONDARY OBJECTIVES:

I. To correlate the MRI signal of ferumoxytol uptake in macrophages with the number of macrophages in surgical tumor specimen at histopathology.

OUTLINE:

Patients receive a single intravenous infusion of ferumoxytol over 15 minutes. After 24 hours, patients undergo ferumoxytol-enhanced magnetic resonance imaging (MRI). Patients will then undergo MRI-localized tissue sampling and tumor resection.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with suspected malignant brain tumor on diagnostic MR imaging who will undergo a resection

Exclusion Criteria:

* Informed consent cannot be obtained either from the patient or legal representative
* Severe coexisting or terminal systemic disease that may interfere with the conduct of the study
* Contraindication to MRI (metal implants)
* Hemosiderosis/hemochromatosis
* Iron overload from any cause (not just hemosiderosis or hemochromatosis), even if secondary to frequent blood transfusions, severe chronic hemolysis, excess dietary or parenteral iron, or any other etiology
* Known hypersensitivity to ferumoxytol or any of its components
* Pregnant patients
A Study to Learn About the Effectiveness of the Medicine Called Elranatamab in People With Relapsed Refractory Multiple Myeloma as Compared With Standard of Care Therapies

This study is to understand how well elranatamab (PF-06863135) may be used for relapsed refractory multiple myeloma (RRMM). Sometimes MM might improve at first, but then gets resistant to the treatment and starts growing again (known as relapsed refractory). This study medicine will be compared with standard-of-care (SOC) therapies used in real-world clinical practice. For people receiving elranatamab, the investigators will use data from the phase 2 clinical trial (MagnetisMM-3). The investigators will also use data from a real-world data source, representing the SOC in clinical practice. This study does not seek any participants for enrollment. The investigators will compare the experiences of people receiving elranatamab to people receiving SOC therapies. This way, it will help the investigators to know how well elranatamab can be used for RRMM treatment.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and older at index date
* Diagnosis of MM
* Measurable disease according to IMWG criteria
* ECOG performance status ≤2
* Refractory to at least 1 proteasome inhibitor, 1 immunomodulatory drug, and 1 anti-CD38 treatment (ie, triple-class refractory \[TCR\])
* At least 1 treatment following their TCR eligibility

Exclusion Criteria:

* Acute plasma cell leukemia
* Amyloidosis
* Smoldering MM
* Stem cell transplant within 12 weeks of index or active graft versus host disease (GVHD)
* Active malignancy within 3 years before index, except for basal cell or squamous cell skin cancer or carcinoma in situ
* Administration with an investigational drug within 30 days prior to index
Transcriptome Study of Acute Myocardial Infarction

This study aims to compare whole-blood microarray gene-expression profiling between patients with acute myocardial infarction and normal participants without cardiovascular diseases. Firstly, screening differentially genes of mRNA to perform gene ontology and pathway analysis. Secondly, predicting target genes regulated by microRNA and constructing coexpression network with mRNA. Thirdly, biological function experiment of microRNA. Finally, revealing pathogenic mechanisms associated with acute myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* AMI patients:

  1. 20-50 years of age
  2. Symptoms of ischaemia
  3. New significant ST-segment-T wave changes in ECG and definitive diagnosis of non-ST elevation MI or ST elevation MI
  4. Cardiac troponin with at least one value above the 99th percentile upper reference limit
* Normal control participants:

  1. 20-50 years of age
  2. Normal ECG
  3. BMI \<24kg/m2
  4. systolic blood pressure \<140mmHg
  5. diastolic blood pressure \<90mmHg
  6. Total cholesterol \<200mg/dl (5.18mmol/L)
  7. Triglyceride \<150mg/dl (1.70mmol/L)
  8. High density lipoprotein cholesterol \>=40mg/dl (1.04mmol/L)
  9. Low density lipoprotein cholesterol \<130mg/dl (3.37mmol/L)
  10. Fasting blood glucose \<100mg/dl (5.6mmol/L)
  11. Not taking antihypertensive or hypolipidemic or hypoglycemic drugs

Exclusion Criteria:

1. Cardiac death with symptoms suggestive of myocardial ischaemia and presumed new ischaemic ECG changes, but death occurred before cardiac biomarkers were obtained, or before cardiac biomarker values would be increased
2. Prior myocardial infarction
3. Percutaneous coronary intervention related MI
4. Stent thrombosis associated with MI
5. Coronary artery bypass grafting related MI
6. Recurrent MI or reinfarction
7. Myocardial injury with necrosis caused by transcatheter aortic valve implantation or mitral clip or ablation of arrhythmias
8. Myocardial injury or infarction associated with heart failure
9. Myocardial infarction in the intensive care unit
10. Other diseases: previous history of ASCVD, cancer, rheumatoid arthritis, liver or kidney disease, myeloproliferative disorders, chronic inflammation, peripheral vascular disease
11. Not available informed consent