cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of LY01011 and Xgeva® in Patients With Bone Metastases From Solid Tumors

This is a multicenter，randomized, double-blind, active-controlled, parallel-group study comparing efficacy and safety of LY01011 (recombinant anti-RANKL human monoclonal antibody injection) and Xgeva® in patients with bone metastases from solid tumors.

The primary objective is to evaluate the similarity of clinical efficacy between LY01011 and Xgeva® in patients with bone metastases from solid tumors.

The secondary objective is to evaluate the similarity of clinical safety and immunogenicity between LY01011 and Xgeva® in patients with bone metastases from solid tumors.

Each subject will participate in the study for 53 weeks. Treatments are administered on day 1 and Q4W thereafter through week 49. All patients are instructed to take 500 mg calcium and 400 IU vitamin D daily.

Eligibility Criteria:
Inclusion Criteria:

* The subject or his/her guardian and/or impartial witness voluntarily signed the written informed consent form（ICF）.
* Aged 18 to 80 Years old (Female or male subjects to the date of signing the informed consent form).
* Subjects with solid tumor confirmed by histological or cytological examination. At least one documented bone metastasis confirmed by computed tomography\[CT\], magnetic resonance imaging\[MRI\]) or pathology (bone biopsy).
* Eastern Cooperative Oncology Group（ECOG）performance status≤2.
* Adequate organ function at baseline.

Exclusion Criteria:

* Prior treatment with denosumab or other RANKL-targeted therapeutic drugs.
* Subjects who previously received any bone-modifying agents (including intravenous or oral bisphosphonates, etc.) for advanced tumor disease.
* Orthopedic surgery or bone-related radiation therapy within 1 month prior to first dose. Bone radioisotope therapy within 6 months prior to first dose, or planned radiation therapy or surgery for bone during the study.
* Past or ongoing osteomyelitis or osteonecrosis of the jaws （ONJ）, an active dental or jaw condition requiring oral surgery, non-healed dental or oral surgery, or any planned invasive dental procedure during the study period.
* Primary central nervous system malignancy. Subjects with central nervous system metastases who have failed local therapy. Subjects with asymptomatic brain metastases or clinically stable brain metastases who do not require steroids and other therapy for brain metastases for ≥ 28 days may be enrolled.
Anatomical and Functional Differences Between Continent and Incontinent Men Post Radical Prostatectomy

One out of every six men will be diagnosed with prostate cancer and post prostatectomy up to 75% report urinary incontinence. There are many hypotheses about the exact cause of post prostatectomy stress incontinence (PPI). Existing studies have focused on surgical or cadaveric dissections to define structures responsible for PPI. Contemporary 3T MRI now allows three dimensional, sub-millimeter resolution of the human pelvis and clearly demonstrates pelvic anatomy without the distortion of dissection. It is our overarching hypothesis that PPI is multifactorial and occurs because of a combination of specific anatomical and functional impairments. We propose conducting a case control study with matching for age and race to compare the MRI anatomy and urinary tract function on urodynamics between 20 men with PPI (cases) and 20 men who are continent post prostatectomy (controls) who are all a minimum of 12 months post surgery. We will use static and dynamic MRI at 3 Tesla to make objective measurements of the bladder neck, external urethral sphincter, pelvic floor, urethral anastomotic fibrosis, and urethral hypermobility- all believed to play a large part in continence. Multi-channel urodynamic studies will also be performed to assess the leak point and maximum urethral closure pressure. All cases and controls will complete standardized questionnaires - the AUA symptom index and the Incontinence Severity Index as a quality of life measure. This study is needed to provide critical information about causes of male PPI, a quality of life altering voiding dysfunction, and will assist with the advancement of pharmacological and surgical treatment of this disease.


Eligibility Criteria:
Inclusion Criteria:

* Only men will be included since this is a study of post prostatectomy incontinence. Cases will be comprised of men who are post radical retropubic or laparoscopic (robotic) prostatectomy who have stress urinary incontinence based on history and a minimum of 50 grams of urine loss on 24 hour pad weights. Controls will be comprised of men who are post radical retropubic or laparoscopic (robotic) prostatectomy who do not have any kind or amount of incontinence based on history. Cases and controls will be matched for both age and race these have been shown to alter anatomical appearance of structures and lower urinary tract function.

Exclusion Criteria:

* Criteria for both groups include urge incontinence, urinary retention, neurologic disease, insulin dependent diabetes, high dose steroid use, pre-surgical abnormal voiding function or incontinence, prior pelvic radiation or urologic surgery, any prior incontinence surgery, current medical therapy for incontinence or a perineal route of radical prostatectomy since this had been shown to give a distinctly different appearance on MRI compared to the laparoscopic or retropubic approach. Any patient with pelvic or systemic recurrence of their prostate cancer will also be excluded. Any man with relative or absolute contraindications to MRI such as implants or claustrophobia will be excluded.
Safety of a Diagnostic Strategy With D-Dimer Testing for PE

To determine whether D-Dimer testing, using the MDA D-Dimer assay, can be used to simplify the diagnostic process for pulmonary embolism (PE). This will be assessed by performing a cohort study in 1000 patients with suspected PE.

To ascertain if an MDA D-Dimer result of less than 0.75 ug/mL FEU obviates the need for further testing and therapy in patients with suspected PE.

Prospective cohort study of 1000 patients in which those with a negative D-Dimer result undergo no further testing and are followed for 3 months for venous thromboembolism. Patients with a positive D-Dimer undergo standardized testing.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Suspected PE

Exclusion Criteria:

* Treatment with full-dose anticoagulants for 24 hours or more OR an ongoing requirement for anticoagulants
* Other tests for PE performed prior to eligibility assessment (e.g.other D-Dimer, V/Q scan, pulmonary angiogram, spiral CT, compression ultrasound, venogram).
* Cardiorespiratory instability requiring immediate performance of other tests to diagnose or exclude PE (i.e. inability to wait 30-60 minutes for MDA D-Dimer result)
* Comorbid condition limiting survival to less than three months
* Patient has been asymptomatic for seven days prior to presentation
* Current pregnancy
* Contraindication to contrast (e.g., allergy, renal failure).
* Geographic in accessibility which precludes follow-up
* Presence of central venous catheter (permanent or temporary, including PICC line) at the time of eligibility assessment
A Study of Irinotecan Plus Cetuximab With or Without Enzastaurin in Participants With Colorectal Cancer

To see how well enzastaurin in combination with irinotecan and cetuximab works versus irinotecan and cetuximab in participants who have progressed within 3 months.


Eligibility Criteria:
Inclusion Criteria:

Participants are eligible to be included in the study only if they meet all of the following criteria:

1. Histologic diagnosis of colorectal cancer.
2. Performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) performance status schedule.
3. Have had documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST v1.0; Therasse et al. 2000) within 3 months after receiving 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) plus bevacizumab as first-line therapy for locally advanced or metastatic disease, or within 6 months after receiving FOLFOX with or without bevacizumab in the adjuvant setting.
4. Standard radiation therapy for rectal cancer is allowed. Participants must have recovered from the toxic effects (except for alopecia) of the treatment prior to study enrollment. Prior radiotherapy must be completed 4 weeks before study entry. Lesions that have been radiated in the advanced setting cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
5. At least one uni-dimensionally measurable lesion meeting RECIST v1.0 guidelines (at least 10 millimeters \[mm\] in longest diameter by spiral computerized tomography (CT) scan, or at least 20 mm by standard techniques). Positron emission tomography (PET) scans and ultrasounds may not be used.

Exclusion Criteria:

Participants will be excluded from the study if they meet any of the following criteria:

1. Have received treatment within the last 4 weeks with a drug that has not received regulatory approval for any indication at the time of study entry.
2. Have previously completed or withdrawn from this study or any other study investigating enzastaurin, irinotecan, or cetuximab.
3. Have a serious concomitant systemic disorder \[such as active infection including human immunodeficiency virus (HIV), or cardiac disease\] that, in the opinion of the investigator, would compromise the participant's ability to adhere to the protocol.
4. Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV.
5. Have a prior malignancy (other than colorectal cancer, or adequately treated carcinoma in-situ of the cervix or nonmelanoma skin cancer), unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Participants with a history of low grade (Gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously.
Immune Function of Colorectal Cancer Lymph Nodes

Lymph nodes are very important immune organs in the human body and play an important role in the physiological and pathological activities of the body, especially in anti-tumor immunity. The role of regional draining lymph nodes in the development of colorectal cancer is still unknown. In this study, the role of lymph nodes in the development of colorectal cancer was investigated through multicenter and multi-omics data.


Eligibility Criteria:
Inclusion Criteria:

* Stage I-III colorectal cancer patients undergoing radical surgery
* Complete imaging, pathology and genetics multi-omics data available
* 18-75 years old

Exclusion Criteria:

* Patients with preoperative neoadjuvant therapy
* Patients with incomplete clinical information
* Patients with other malignant tumors
* Patients with acute infections or untreated chronic infections
Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease

Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia (CLI), which is the most severe form of peripheral arterial disease (PAD); This trial is designed to assess the efficacy and safety of the drug in the treatment of CLI.


Eligibility Criteria:
Inclusion Criteria:

* Critical leg ischemia (CLI) defined as distal extremity pain at rest, or peripheral ischemic ulcer(s), with severe hemodynamic impairment as diagnosed by ankle systolic pressure, toe systolic pressure or TcPO2
* Subjects will already be scheduled to receive a revascularization procedure (e.g., by-pass graft, endovascular procedure, etc.) involving a distal target artery below the knee joint (e.g., below the knee joint popliteal, anterior/posterior tibial, peroneal, plantar, pedal, etc.) as part of their normal standard of care.

Exclusion Criteria:

* Subjects with a previous major amputation (at or above ankle)
* Subjects with end stage renal disease (ESRD) defined as significant renal dysfunction evidenced by estimated creatinine clearance of \< 20 cc/min, or receiving chronic hemodialysis therapy.
Clinical Study to Evaluate the Possible Efficacy of Dapagliflozin and Atorvastatin in Patients With Major Depressive Disorders

Major depressive disorder (MDD) is a significant cause of disability that affects approximately 16% of the world's population and is associated with chronic inflammation. Although the mechanisms of MDD have not yet been clearly elucidated, NLRP3 inflammasomes have been implicated in the pathogenesis of depression.NLRP3 inflammasome is an intracellular multiprotein complex that consists of nod-like receptor protein 3, an adaptor protein, and a procaspase-1 precursor. It is well known that a variety of danger signals, such as pathogen-associated molecular patterns and danger-associated molecular patterns can activate NLRP3 inflammasome


Eligibility Criteria:
Inclusion Criteria:

- Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception. Depressed patients for at least 2 months with a Hamilton rating score of more than 18.

Exclusion Criteria:

* Patients with bipolar I or bipolar II disorder
* Patients with personality disorders
* Patients with eating disorders
* Patients with substance dependence or abuse
* Patients with concurrent active medical conditions
* Patients with a history of seizures
* Patients with a history of receiving Electroconvulsive therapy (ECT)
* Patients with inflammatory disorders
* Patients with allergies or contraindications to the used medications
* Patients with finally pregnant or lactating females
* Diabetic or hyperlipidaemic patients
A Study Evaluating the Safety of the Nasal Pump

The objective of this study is to determine the safety of the Tyrvaya nasal pump.

The study is testing the hypothesis that the use of the Tyrvaya nasal pump with silicone lubricant does not introduce any additional safety concerns as compared to the safety of the Tyrvaya nasal pump without the additional silicone lubricant.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age
* Have provided verbal and written informed consent
* Willing to comply with all study related visits and procedures

Exclusion Criteria:

* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1.
An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain

The purpose of this study is to assess the safety of the long-term use of pregabalin at doses up to 600 mg/day in patients with central neuropathic pain (post spinal cord injury pain, post stroke pain, and multiple sclerosis pain).


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for subjects to be shifted from Study A0081107

* Subjects who completed the 18-week study period in Study A0081107 conducted for chronic neuropathic pain after spinal cord injury;
* Subjects who completed assessments of all efficacy endpoints until the end of the treatment phase of the preceding Study A0081107 (V7);

Inclusion criteria for subjects to be new participants in this study

* Subjects with central neuropathic pain after stroke or multiple sclerosis;
* At least 6 months have passed after the onset of central neuropathic pain;
* Pain VAS at least 40mm in Visit 1 and Visit 2;

Exclusion Criteria:

* Creatinine clearance \< 60 mL/min;
* Platelet count \< 100 × 103/mm3 ; White blood cell (WBC) count \< 2500 / mm3; Neutrophil count \< 1500/ mm3;
* Subjects who are expected to require surgery during the trial;
Clinical Evaluation of Tissue Sampling Bias in Histologic Evaluation of Sentinel Lymph Nodes in Breast Cancer

This is a study to evaluate the incidence of sampling bias during pathologic assessment of sentinel lymph nodes (SLN) when they are cut at a certain thickness (1 mm) and the tissue slices are completely analyzed by histopathology (at 200 µm sections). The sponsor and investigators would like to determine how often small cancer deposits are present in one slice but not the other. The data will provide an empirical estimate of the incidence of tissue sampling bias inherent in using different tissue sections for analysis. The data will also show how varying degrees of detail in evaluating the sentinel lymph nodes (SLN) with histopathology methods will impact the degree of agreement.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18 years of age or older
* Diagnosed pre-surgically with T1 or T2 breast cancer and scheduled for surgery including sentinel lymph node dissection
* Subjects (or the subject's legal representative) who have read, understood (to the best of their ability) and signed the informed consent form.

Exclusion Criteria:

* Subjects diagnosed pre-surgically with large or locally advanced (T3 \& T4) breast cancer
* Pregnant subjects, confirmed by interview with either subject or treating physician
* Subjects diagnosed with inflammatory breast cancer
* Subjects diagnosed with ductal carcinoma in situ (DCIS) when breast conservation is to be done
* Subjects with clinically suspicious, palpable axillary lymph nodes
* Subjects previously treated for or previously diagnosed with another type of invasive cancer. Subjects with skin cancer (basal cell and squamous cell carcinoma) may be included, except for subjects diagnosed with melanoma
* Subjects who have received pre-operative systemic therapy
* Subjects who are incapable of providing written informed consent
* Subjects who have been judged to be an inappropriate candidate by any medical care provider (e.g., surgeon, oncologist or pathologist).
Acorai Machine Learning Generalization (MLG) Study

Acorai is developing a non-invasive monitoring system for the estimation of intracardiac hemodynamic parameters in patients with suspected or confirmed heart failure, and/or pulmonary hypertension, who require hemodynamic assessment. The device will be intended as a companion test or clinical decision support tool to be used and interpreted by qualified healthcare professionals to aid standard-of-care clinical assessment in identifying hemodynamic congestion and supporting personalized treatment of heart failure and pulmonary congestion.

This study is part of the development of a non-invasive monitoring system for the estimation of intracardiac hemodynamic parameters. It will be conducted to collect the data needed to train the machine learning models retrospectively.


Eligibility Criteria:
Inclusion Criteria:

* Subject is, at least, 18 years of age at the time of screening visit.
* Subject is willing and physically able to comply with the specified evaluations as per the clinical investigation plan, as assessed by the investigator.
* Subject is referred for invasive hemodynamic assessment with right heart cardiac catheterization.
* Patient has provided written informed consent using the Ethics Committee/ Institutional Review Board approved consent form.

Exclusion Criteria:

* Discretionary exclusion when, in the opinion of the investigator, the inclusion of a potential subject is not in their best interest or not in the interest of compliant performance of the clinical investigation.
* Subjects who are pregnant are excluded in the US
Clinical Evaluation of an Experimental Remineralization Product

The study is designed as a split-mouth randomised controlled study. This means within the mouth of one patient one tooth with an initial lesion is treated and coated with the Experimental Remineralization product whereas another comparable tooth with an initial lesion is left untreated. Patients are included upon meeting the inclusion criteria as defined for this clinical trial. In the test group, a remineralization of the incipient carious lesion is expected. The patients are recalled after 1 day (optional), 4 weeks, 4 months and finally after 1 year to evaluate the untreated and treated lesion.


Eligibility Criteria:
Inclusion Criteria:

* At least two incipient carious lesions on the buccal or oral surface of a permanent tooth. Neighbouring teeth should not be in two different groups. There is no maximum amount of lesions.
* Active caries lesion
* Patient at risk of caries
* Vital teeth

Exclusion Criteria:

* Pregnancy
* Enamel detachment at the site of investigation
* Allergies (DoReMin)
* Chronic diseases
Study to Evaluate the Efficacy of Bite's Natural Deodorant

This is an open-label observational single-arm clinical trial to study the efficacy of a commercial deodorant and its effect on odor, clothing (stains), and quality of life. It is hypothesized that the deodorant marketed as Bite deodorant will mask bodily odor in participants, will not stain clothes, and improve the quality of life in trial participants.


Eligibility Criteria:
Inclusion Criteria:

* Agree to refrain from the use of any other deodorant or antiperspirant other than Bite for the study period
* Must be in good health (does not report any medical conditions asked in the screening questionnaire)
* Must be willing to comply with the requirements of the protocol
* Must be willing to add the deodorant to their daily routine
* Is willing and able to share feedback
* Shower daily, and put deodorant on the first thing in the morning (before sweating)
* If used deodorants previously must be a natural version

Exclusion Criteria:

* Unwilling to follow the routine of the protocol
* Currently participating in another research study
* Severe chronic conditions including oncological conditions, psychiatric disease, or other
* Females that are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
* Presence of self-reported armpit sensitivity
* Known to have severe allergic reactions
* Have known allergies to the trial product ingredients
* Currently using an antiperspirant