cyrilzakka/clinical-trials huggingface dataset:
PRGN-2009 in Combination with Pembrolizumab Versus Pembrolizumab in Patients with Recurrent or Metastatic Cervical Cancer

This randomized trial will evaluate the efficacy and safety of PRGN-2009 in combination with pembrolizumab compared to pembrolizumab alone in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.

This is a randomized, two-arm study of PRGN-2009 in patients with recurrent or metastatic cervical cancer who are pembrolizumab resistant. Patients meeting all eligibility criteria who consent to participate in the study will be randomized 1:1 to receive a combination of PRGN-2009, plus pembrolizumab, or to receive pembrolizumab alone.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older.
* Recurrent or metastatic cervical cancer (histologically or cytologically confirmed) that meets the criteria of pembrolizumab-resistant.
* Must have been treated with pembrolizumab, either as monotherapy or in combination
* Patients must have received no more than two prior systemic regimens in the recurrent or metastatic setting
* Tumors are confirmed positive for PD-L1 and HPV16/18
* Measurable disease that can be accurately measured by RECIST v1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy ≥ 12 weeks from the time of enrollment.
* Must have adequate organ function
* Negative serum pregnancy test. Women of child-bearing potential (WOCBP) must agree to use adequate contraception prior to study entry and for at least 6 months following completion of study treatment.
* All patients must have the ability to understand and willingness to sign a written informed consent.

Exclusion Criteria:

* Patients with presence of other active malignancy within 1 year prior to study entry
* Known Central Nervous System (CNS) disease
* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
* Known history of active tuberculosis (TB, Bacillus tuberculosis).
* Pregnant and lactating women are excluded from this study.
* Patients with a history of solid organ transplant.
* Patients currently participating in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of study treatment.
* Patients, who in the opinion of the investigator, may not be able to comply with the monitoring requirements of the study.
Breathing Training to Improve Human Performance at High Altitude

Individuals traveling to altitudes above 8,000 feet may suffer from impaired exercise and cognitive performance, and acute mountain sickness (AMS). Decreased barometric pressure, which leads to low blood oxygen levels, is the primary cause of these disorders. Symptoms of AMS are characterized by headache, nausea, vomiting, dizziness, fatigue, and difficulty sleeping. The goal of this research is to identify whether Respiratory Muscle Training will improve physical and cognitive performance, and reduce the symptoms of AMS, at simulated high altitude.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Men, ages 18-45 who are able to achieve at least 3.5 watts/kg of body weight during the peak oxygen uptake test

Exclusion Criteria:

* Less than 18 years old
* Greater than 45 years old
* Have a body mass index greater than or equal to 30
* Have been recent smokers (tobacco or e-cigarettes)
* Current recreational or medical marijuana users
* Currently taking any medication (over-the-counter or prescription) or herbal supplements
* Participants who are unable to tolerate drinking only two, 6-ounce caffeinated beverages per day of the study
* Participants who are legally blind
* Participants who have been to altitudes above Denver (1609m or 5280ft), including air travel, in the 3 weeks prior to the start of the study or with plans to do so during the study
* Participants who have suffered a significant head injury, have anemia or sickle cell trait or disease, have active peptic ulcer disease, diabetes, hypertension, heart disease, HIV/AIDS, glaucoma, kidney disease, liver disease/cirrhosis, adrenal gland failure, hyponatremia/hypokalemia, tuberculosis
* Participants who have a current herpes infection or any other current type of viral or bacterial infection
* Participants with seizure disorders or history of migraines
Evaluation of Physician Volumetric Accuracy During Filler Injections

Objectives

1. Evaluate the ability of aesthetic physicians to accurately inject a specific amount (i.e., 0.2cc) of HA soft tissue filler; and
2. Investigate the effect of different HA gel properties (e.g., G', cohesivity, viscoelasticity) on an injector's performance accuracy.


Eligibility Criteria:
Inclusion Criteria:

* Board-certified plastic surgeon, dermatologist, or oculoplastic surgeon.

Exclusion Criteria:

* N/A
Innovative Imaging of the Conjunctiva, Cornea, and Ocular Adnexa

In vivo confocal microscopy (IVCM) used in tertiary care ophthalmology centers is performed with two reflectance microscopes attached on a mounting with limited movement along the XYZ axes. Consequently, ocular diseases in the central area have been described (mostly cornea and adjacent conjunctiva). Two dermatology IVCM (an handheld small IVCM and a multifluorescent one) present significant innovations that the investigators want to assess in ophthalmology for the diagnosis of conjunctiva, cornea, eyelid and lachrymal tract diseases. The handheld IVCM have unlimited degrees of freedom and a small diameter objective. It could dramatically increase the area accessible to IVCM (whole conjunctiva, eyelids, proximal lachrymal tract) (part 1 of the present study). The fluorescent IVCM allows the use of a wide range of fluorescent markers liable to increase the specificity of the diagnosis by revealing staining patterns corresponding to a specific disease and not to others (part 2 of the study)


Eligibility Criteria:
Inclusion Criteria:

* Presenting with an ocular or ocular adnexa disease (infectious keratitis, stromal dystrophy, corneal surgery, ocular surface toxicity of eyedrops, cornea-conjunctival tumors, chronic blepharitis, eyelid tumors, diseases of the proximal lachrymal tract).
* For the microangiography: diabetic patients

Exclusion Criteria:

* Allergy to one of the 3 dyes (fluorescein, indocyanine green, rose Bengal)
* Pregnancy and breast feeding
* Predicable impossible follow up
* For patient volunteer for intravenous injections: beta blockers
Comparison of Intravenous Injection of Calcium Antagonist and Beta-blockade on Endothelial Shear Stress of Coronary Artery

Both calcium channel antagonist and beta-blocker have cardioprotective effect. Endothelial shear stress is predictive factor of clinical outcomes in patients with obstructive stenosis.

The present study aims at comparing the re-distribution of shear stress and blood velocity during whole cardiac cycle after trans-coronary injection of Nicardipine and esmolol.

Blood flow-induced endothelial shear stress has strong effect on endothelial function and development or progression of plaque formation. It is extensively accepted that low and/or oscillating shear stress causes endothelial dysfunction and is one of crucial factors in localizing early atherosclerosis .In contrary, normal and high shear stress is atheroma protective and is involved in compensatory remodeling . Most studies reported that the endothelial shear stress distribution in often idealized geometrical models of human coronary arteries was the subject of numerous investigations , and in these studies it was shown that the geometry of coronary arteries is the main determinant of the observed shear stress distribution. Generally, downstream of a plaque, low shear stress can be expected, Several cardiovascular active drugs have been shown to be cardio-protective for patients with obstructive coronary disease. Of these drugs, calcium channel blocker is one of most prescribed in everyday clinical practice. Ninomiya et al. reported calcium channel blocker was associated with increased coronary diameter and blood fluid with dose-dependent pattern in patients with normal or mild stenotic coronary artery. However, no reports on the dynamic change of endothelial shear stress after calcium channel blocker in -vitron were published so far. As a result, the aim of this study was to evaluate the effect of intra-venous injection of Nicardipine, one calcium channel blocker with shorter half-time, on the re-distribution of endothelial shear stress in patients with acute coronary syndrome and mild stenotic (\<50%) coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of unstable angina and non-Q wave myocardial infarction
* Age 18-75 yr.
* Diameter stenosis of coronary artery\<70% diameter stenosis by visual estimation
* Blood pressure \>110/70 mmHg
* Heart rate 60-\~100 bpm, No cardiac arrhythmias

Exclusion Criteria:

* St-elevation myocardial infarction
* Lower blood pressure(\<100/70mmHg)
* Heart rate \<60 or \>100 bpm, The presence of cardiac arrhythmias
* Allergy to study drugs
* Women in pregnancy
* Liver dysfunction
* Creatinine \>2.5mg/dl
* Bleeding stroke within 6 months
* Left ventricular ejection fraction\<30% before maximal medication
Investigate the Effect of AZD1656 on the Pharmacokinetics and Pharmacodynamics of Warfarin in Type 2 Diabetes Mellitus (T2DM) Patients

The purpose of this study is to determine whether AZD1656 will affect the Pharmacokinetics and Pharmacodynamics of Warfarin in T2DM patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of T2DM treated with at least 1000 mg metformin as a single treatment or in combination with one other oral anti-diabetics for at least 2 months prior to screening. Doses of anti-diabetic treatment stable for at least 1 month
* Fasting plasma glucose (FPG) at screening in the range of 6.0 to 15.0 mmol/L (108 to 270 mg/dL) and FPG in the range of 7.5 to 13.0 mmol/L (135 to 234 mg/dL) on Day 1
* Haemoglobin (Hb) A1c \>6.5% at screening

Exclusion Criteria:

* Use of drugs with anticoagulant effects 3 weeks prior to first warfarin dosing
* Use of amiodarone within 3 months prior to screening and the use of potent CYP450 inhibitors
* Previous treatment with warfarin on clinical indication
Assessment In a Real World Setting of the Effect of Inhaled Steroid-based Triple Therapy Versus the Combination of Tiotropium and Olodaterol on Reducing Chronic Obstructive Pulmonary Disease (COPD) Exacerbations [AIRWISE]

The primary objective of this pragmatic study is to compare the time to first moderate or severe COPD exacerbation in patients, not controlled on their current therapy, randomized to Stiolto Respimat versus triple therapy over 12 months of treatment

The secondary objectives of this study include:

1. To compare the annual rate of moderate or severe COPD exacerbations for patients on Stiolto Respimat with patients on triple therapy.
2. To compare the time to first severe COPD exacerbation in both treatment arms.
3. To compare the annual rate of severe COPD exacerbations in both treatment arms.
4. To compare the proportion of patients with moderate or severe COPD exacerbations in both treatment arms.


Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis as defined by the study physician
* Currently on one of the following maintenance therapies:

  * LAMA monotherapy
  * LABA monotherapy
  * ICS/LABA (FDC)
* Physician determination that patient is not controlled on current pharmacotherapy
* Adult patient 40 years of age or older at time of study enrollment
* Willingness and ability to understand and provide documented Informed Consent Form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form prior to commencement of any study required assessments, either directly or through Legally Authorized Representative.

Exclusion Criteria:

* Currently on LAMA/LABA (free or FDC) or triple therapy (ICS plus LABA plus LAMA)
* Contraindication to any study medications (LAMA, LABA or ICS)
* Documented diagnosis of current asthma
* Pregnant or nursing women
* Women of childbearing potential are not restricted in this trial, however it is expected that the investigator will assess the risks and benefits of the assigned treatment as per the product label(s) and discuss this with any women of childbearing potential prior to providing the patient with the prescription for the assigned treatment.
Prediction of Intraoperative Adhesions Before CS

To predict the presence of intra-abdominal adhesions among women undergoing repeated cesarean section using several parameters.

One of the most frequently performed surgical procedures globally is cesarean delivery (CD). Cesarean delivery rate is increasing, which raises the prevalence of intra-abdominal adhesions . The rate of intra-abdominal adhesions is 24-83% . Adhesions cause various postoperative complications, including intestinal obstruction, pelvic pain, dyspareunia, infertility, visceral injury, delayed delivery of the newborn , prolong surgical duration, increase bleeding amount and the incidence of hysterectomy . For these reasons, obstetricians always want to identify the possible extent of adhesions before cesarean section. Although to date there was no reliable technique to predict adhesions in women undergoing repeat CD .

Methods used in the evaluation of adhesions include the previous cesarean scar features, pigmentation, width and length , ultrasound sliding sign has been used in predicting pelvic endometriosis ,Baron et al. ,used the sliding sign in predicting adhesions in women undergoing repeat CD, also Stretch marks are a type of skin alteration that occur during pregnancy.

To ensure better surgical outcomes and reduce morbidities, the accurate prediction of adhesion formations before cesarean section is important. This study aims to investigate the integration of multiple parameters, such as evaluating cesarean scars, ultrasound sliding sign, and striae gravidarum, to assess intra-abdominal adhesions. We hypothesize that employing a combination of these parameters will yield superior predictive capabilities compared to relying on a single parameter alone. By exploring a comprehensive approach to adhesion prediction, we endeavor to enhance the safety and efficacy of cesarean section procedures, ultimately improving maternal and fetal well-being.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women aged from 18 to 35 years
2. Women with at least one previous C-section
3. Gestational age (≥36 weeks)
4. Planned elective cesarean section

Exclusion Criteria:

1. primigravida
2. Gestational age (\<36 weeks)
3. Pregnant woman who had developed wound site infections following prior cesarean section
Effectiveness and Safety of Combination Mifepristone/Misoprostol for Medical Abortion

National multi-center non interventional study aiming at investigating the effectiveness and safety of the combination mifepristone-misoprostol prescribed in Canada to women for medical termination of pregnancy at or before 63 days gestational age through a multi-center prospective non interventional study design.

Primary Objectives:

* Effectiveness of mifepristone-misoprostol for medical abortion at or prior to 63 days gestational age, defined as complete abortion without further intervention within 14 days of mifepristone administration
* Safety of mifepristone-misoprostol for medical abortion at or prior to 63 days gestational age, defined as the rate of significant Treatment Emergent Adverse Events (TEAE) as a composite outcome of the following events: 1. Hospital Admission; 2. Treatment in Emergency Room; 3. Blood Transfusion; 4. Infection requiring IV Antibiotics, Admission, or Surgical debridement; 5. Death; 6. Ongoing intrauterine pregnancy; 7. Ectopic pregnancy.

Secondary objectives:

* To determine the rate of ongoing pregnancy within 14 days after the administration of mifepristone
* To determine the rate of surgical aspiration performed at the follow-up and time since mifepristone administration
* To determine the reasons for surgical aspiration
* To evaluate the follow-up rate
* To evaluate the delay between the scheduled and actual treatment administration
* To determine the overall safety profile of mifepristone-misoprostol combination
* To evaluate the impact of the demographic characteristics (prescription site, region, gestational age) on effectiveness and safety
* To evaluate the impact of gestational age on effectiveness and safety
* To evaluate the impact of treatment self-administration on effectiveness and safety
* To evaluate the impact of the method and timing of determining gestational age on effectiveness and safety

Study population:

Study performed on a stratified sample of sequential participants (n=3,000) who fulfill trial selection criteria and provide informed consent across a range of clinical practices in Canada (n=30)

Eligibility Criteria:
Inclusion criteria

Women who:

* request elective pregnancy termination in one of the sites participating into the study
* are prescribed mifepristone-misoprostol for this purpose
* provide informed consent to participate in the study.

Exclusion Criteria:

* Participant who is unable to understand or comply with Health Care Professional instructions or medical abortion regimen
* Participant who is unable or unwilling to provide written informed consent.
Phase I/II Study of Itraconazole for Blastomycosis, Histoplasmosis, and Sporotrichosis

OBJECTIVES: I. Evaluate the tolerance of patients with blastomycosis, histoplasmosis, and sporotrichosis to different doses of itraconazole (R51,211).

II. Determine levels of itraconazole in serum and other body fluids. III. Assess the course of illness during itraconazole therapy. IV. Determine the dosage of itraconazole that is safe and well tolerated by 80%-90% of patients and estimate the potential of this dosage for use in future comparative trials.

PROTOCOL OUTLINE: This is a study to estimate the optimal dose of oral itraconazole. Patients are treated at 1 of 3 doses of itraconazole; the starting dose for each patient is determined at entry.

Therapy is administered daily for 3-6 months. Patients with progressive disease may be treated at the next higher dose; there may be only 1 such increase. Concurrent systemic and topical antifungals are prohibited.

Patients are followed at 1, 3, 6, and 12 months.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Culture-proven fungal disease, i.e.: Chronic cavitary histoplasmosis Extrapulmonary histoplasmosis, e.g., mucosal disease Blastomycosis Sporotrichosis Positive culture after last dose of any prior therapy Requires antifungal therapy with amphotericin B or ketoconazole No fungal meningitis No central nervous system disease No immediately life-threatening disease --Prior/Concurrent Therapy-- At least 1 month since therapy for same disease No more than 2 mg/kg prior amphotericin B (total dose) No more than 2 mg/kg prior ketoconazole (total dose) No concurrent immunosuppressives, including: Corticosteroids Azathioprine Cytotoxic agents --Patient Characteristics-- Hepatic: AST no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Bilirubin no greater than 3 mg/dL Other: No acquired immunodeficiency syndrome No pregnant or nursing women Effective contraception required of fertile women
Efficacy and Safety of Four Escalating Dose Regimens of TPI ASM8 in Patients With Allergic Asthma

During this proposed clinical trial, the investigators intend to evaluate the pharmacodynamic anti-inflammatory properties and safety of TPI ASM8, by investigating the effect on sputum eosinophils and the airway responses during an allergen challenge at different dose levels.

The early and late asthmatic response were both significantly attenuated by the highest dose of ASM8. The methacholine challenge and other parameters (ECP, mRNA knockdown on CCR3 and B-Chain of IL-3-Il-5 and GMCSF were attenuated by ASM8.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 to 65 years of age
* Generally good health; steroid naïve (or who have not taken inhaled/oral corticosteroid within last month) mild to moderate, stable, allergic asthma as defined by ATS criteria
* History of episodic wheeze and shortness of breath
* Forced expiratory volume in one second (FEV1) at baseline ≥ 70% of the predicted value
* Able to comprehend and follow all required study procedures; willing and able to sign an informed consent form.

Exclusion Criteria:

* Significant acute or chronic medical or psychiatric illness
* Known coagulopathy, worsening of asthma or respiratory infection in the preceding 6 weeks
* Use of inhaled or oral corticosteroids within the last 30 days, or need for antihistamines within 72 hours of each allergen or methacholine challenge, immunosuppressives, nonsteroidal anti-inflammatory drugs, or anticoagulants (intermittent doses of short-acting β2-agonist are allowed).
Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma

AMP-005 is a Phase 1b/2 clinical trial designed to evaluate whether the new drug, imexon, can be administered in combination with the approved drug, dacarbazine (DTIC), for the treatment of patients with stage III or IV inoperable melanoma. The Phase 1b part of the study is designed to determine whether the two drugs can be safely combined together, and the Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether adding imexon to DTIC can improve the outcome for melanoma patients versus the findings from prior clinical studies of DTIC alone.


Eligibility Criteria:
Inclusion Criteria:

* Malignant melanoma; inoperable stage III or IV disease.
* Able to perform the activities of daily living.
* A projected life expectancy of at least 4 months.
* If female, neither pregnant nor nursing.
* Willing to use contraceptives to prevent pregnancy.
* Blood cell counts and blood chemistries in or near normal range.
* Prior radiation is permitted.
* No other serious illnesses.
* No other active malignancy.
* No serious infections.
* No other current drug therapy for the cancer or steroid therapy.

Exclusion Criteria:

* No prior chemotherapy for the stage III or IV disease.
* Brain metastases