Infections

Skin and Connective Tissue Diseases

All Conditions

Musculoskeletal Diseases

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Warts

Foot Diseases

Communicable Diseases

Papillomavirus Infections

Virus Diseases

DNA Virus Infections

Skin Diseases

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

Pharmaceutical Solutions

All Drugs and Chemicals

Vasodilator Agents

Respiratory System Agents

Nitric Oxide

Bronchodilator Agents

Anti-Asthmatic Agents

Antioxidants

Neurotransmitter Agents

Endothelium-Dependent Relaxing Factors

Protective Agents

Foot bath with nitric oxide releasing solution (NORS) at 1X dosage delivered 3 times weekly (Mon, Wed, Fri).

500mL NORS in a footbath @ 4110 ppm\*min

Foot bath with nitric oxide releasing solution (NORS) at 2X dosage delivered 3 times weekly (Mon, Wed, Fri).

500mL NORS in a footbath @ 12190 ppm\*min

Foot bath with sterile water delivered 3 times weekly (Mon, Wed, Fri)

500mL sterile water in a foot bath.

Participants will use the same foot bath and sterile water used in the treatment arm minus the active ingredients.

Sterile water foot bath

Participants will use a foot bath filled with 500mL of NORS for 15 min. The solution's two components are mixed 1:1 to 500mL in the foot bath immediately before treatment. The solution contains NO at 68.9ppm\*hrs and 203.2ppm\*hrs for 1X and 2X solutions respectively, and it acts as a virucidal agent. Instructions for storage, handling, and use will be provided to site staff and participants.

Keith Moore, PHARMMD

A phase 2a multicenter, randomized, double-blinded, placebo-controlled clinical trial to evaluate the safety and efficacy of topical nitric oxide releasing solution (NORS) for the treatment of human papillomavirus (HPV) caused verrucae plantaris (plantar warts). Participants will be treated over a 21 day period with a final evaluation on Day 35. They will be separated into 3 treatment groups (placebo, 1x and 2x dose). Participants will be evaluated for change in wart size, wart clearance, and HPV genotype.

This is a multicenter, randomized, double-blinded, placebo-controlled phase 2a clinical trial to evaluate the safety and efficacy of NORS in adolescent and adult volunteers as a treatment for verrucae plantaris (plantar warts). Participants aged 12 or older with plantar warts on the bottom of the foot (feet) will be enrolled into one of 3 cohorts in a ratio of 1:1:1 (NORS1X, 3 doses/week; NORS 2X, 3 doses/week; placebo vehicle, 3 doses/week for 3 weeks).

Participants with or without underlying medical conditions (unless exclusionary) seeking treatment at the site for plantar warts will be eligible. Eligible recruited participants will have three or more currently active plantar warts on the bottom of their foot/feet. Participants who are currently pursuing other forms of treatment (e.g., over-the-counter wart removers, a treatment recommended by their physician, or are waiting for a current treatment) will be excluded from the study.

After enrollment and randomization participants will self-administer study treatment--defined as either blinded study NORS footbath treatment, or placebo vehicle (sterile water) footbath treatment--three times a week for three weeks. Study treatment will be delivered via a single footbath filled with 500 mL of NORS solution. Placebo treatment will be delivered via a single footbath filled with 500 mL of vehicle solution. Each treatment will be a 15-minute soaking time per foot. If both feet are affected, the participant will receive the same treatment on both feet. Thirty (30) participants will be enrolled, with 10 participants per treatment. The study duration is five weeks, which includes Screening/Baseline (Day 0), 3 weeks (21 days) of Treatment, and 14 days of Follow-Up. Lesions will be scored at enrollment (Day 0) and subsequently at follow-up visits (Day 7, Day 14, Day 21, Day 28, and Day 35).

The primary endpoint is to evaluate the efficacy of NORS to provide lesion clearance by photographic lesion length measurement (Day 35). Photographs and counting of warts will be performed at each visit. Wart length and clearance evaluation will be recorded at each site visit to Day 35. Lesion clearance is defined as a length of 0 mm. After each wart assessment (at site visits), warts may be debrided, as necessary per the investigators' evaluation and standard of care. Secondary endpoints will assess lesions for the mean reduction in dimensions as measured by the change in longest length size from baseline observed at Days 7, 14, 21, 28, and 35; lesion clearance by Physician Wart Assessment (PWA=0); and pain reduction using an 11- point Pain Numeric Rating Scale (NRS; 0 to 10), An exploratory endpoint will evaluate the distribution of HPV genotypes determined by swabbing the overlaying skin of the wart from participants at baseline. Participants will additionally have their vitals tracked and skin visually assessed for inflammation at baseline (Day 0) and follow-up visits (Day 35). Adverse events will also be tracked as a measure of safety. The discontinuation rate for tolerance (unless for a lack of perceived efficacy) will also be tracked.

Participants will have six on-site visits. Screening and randomization will be completed on Day 0 followed by a three-week (21-day) treatment period (until Day 21). A site visit will occur on Day 7, Day 14, and at the end-of-treatment (EOT) site visit on Day 21. The treatment period will be followed by a 14-day follow-up period, with a visit on Day 28 and an end-of-study (EOS) visit on Day 35. During the entire study, the participant will be instructed to keep a daily journal of observations to report to the site investigator at their visits, i.e., when they observed each lesion's clearance, new occurrences of lesions, or recurrence of the same lesions.

During the visits on Days 7, 14, 21, 28, and 35 (Follow-Up), the investigator/study staff will review and assess information about lesion clearance, pain, other outcomes, and/or adverse events. At the screening/baseline/randomization visit and at the EOT visit, the patient's medical history (including prior/concomitant illness, medication, adverse event), physical examination, and vital signs assessment will be conducted/recorded. Urine pregnancy tests will be conducted in women of childbearing potential at the screening visit and at EOT visit/early termination visit.

Data collection and monitoring will be performed remotely and on-site. Screening and enrollment will take place on-site with consenting procedure performed in-person on-site. Participants will receive study treatment directly from the site. No laboratory bloodwork assessments will be performed.

Nitric Oxide Releasing Solution (NORS) For The Treatment Of Human Papillomavirus(HPV) Verrucae Plantaris (Plantar Warts)

Phase 2a Multicenter, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial To Evaluate The Safety And Efficacy Of Topical Nitric Oxide Releasing Solution For The Treatment Of Human Papillomavirus Verrucae Plantaris

HPV genotypes will be determined by swabbing the overlaying skin of the warts from participants at baseline. Analysis will be performed using a multiplex PCR reaction.

Lesion clearance will be evaluated by the Physician Wart Assessment tool (PWA=0 on Day 35).

Dermatology Life Quality Index (DLQI) (questions score change from baseline at Day 35)

The efficacy of NORS as measured by the clearance of the wart(s) defined by a photographic lesion measurement of zero (0) length and as compared to a placebo treatment

Reduction in lesion (plantar wart) size measured in millimeters with each NORS dose as compared to reduction with placebo treatment. Measurement of the longest dimension will be recorded and the mean reduction in dimensions as measured by the change in size from baseline observed at Day 7, 14, 21, 28 and 35.

Changes in the size (area) of lesion from baseline will be measured on each visit.

Number of participants who experience reduced pain in their lesions and the time to reduction. This will be scored on an 11-point Pain Numeric Rating Scale (NRS; 0 to 10). Lesions will be scored at enrollment, daily by participants, and subsequently on follow up visits (Day 7, 14, 21, 28 and 35).

Number of participants who find the NORS treatment tolerable.

Sanotize Research and Development corp.

Heart and Blood Diseases

Rare Diseases

Myocardial Infarction

ST Elevation Myocardial Infarction

Infarction

Necrosis

Ischemia

Tissue Adhesions

Coronary Artery Disease

Myocardial Ischemia

Heart Diseases

Vascular Diseases

Acute Graft Versus Host Disease

Hypoglycemic Agents

Fibrinolytic Agents

Reproductive Control Agents

Insulin

Insulin, Globin Zinc

Plasminogen

Plasminogen Inactivators

Dinoprost

Dinoprost tromethamine

Plasminogen Activator Inhibitor 1

In this group study, a condition of Hyperinsulinemia/Euglycaemia will be held trough clamp study, during witch FMD will be measured before and after ischemia/reperfusion injury.

In this group study, a condition of Hyperinsulinemia/Hyperglycemia will be held trough clamp study, during witch FMD will be measured before and after ischemia/reperfusion injury.

In this group study, a condition of Hypoinsulinemia/Hyperglycemia will be held trough clamp study, during witch FMD will be measured before and after ischemia/reperfusion injury.

Andrei C Sposito, PhD, MD

Riobaldo R Cintra, MD

Thiago Quinaglia, PhD, MD

Valeria N Figueiredo, PhD

The objective of this study is to investigative the influence of different levels of glycaemia or insulinemia in vascular endothelium in ischemia/reperfusion lesion after myocardial infarction

The study will include patients consecutively admitted with acute myocardial infarction at State University of Campinas Hospital. Participants will be evaluated during hospitalization and, after they fulfill the inclusion criteria and sign an informed consent, it will be collected a brief medical history and recorded results from glycated hemoglobin (HbA1c), glycaemia, total cholesterol (TC), triglycerides (TG), HDL cholesterol (HDL-C), C-reactive protein (CRP), urea (U), creatinine (Cr), markers of myocardial necrosis (troponin T and CK-MB), Hemoglobin, Red blood cell, Leucocytes, Na, K, Ca and Mg.

In the first week after infarction, from admission until the realization of the clamps experiments (the medical procedure where blood glucose and insulin levels will be controlled), all medications prescribed, medical history and examination will be recorded, as well as follow-up during hospitalization.

At the day of the clamp, between 144 and 168 hours after infarction, volunteers will be randomized to one of the three situations with different glycemic and insulinemic conditions, i.e., a) high insulinemia and low glycaemia, b) high insulinemia and high glycaemia and c) low insulinemia and high glycaemia. During these experiments, endothelial vasomotor function will be recorded in four periods: i) before initiation of the procedure, ii) after 1h of the beginning, iii) 30 minutes after the second procedure and iv) 15 minutes after the simulation of ischemia/reperfusion lesion. In each time point, the investigators will collect plasma to dose inflammatory, oxidative stress and vascular activation markers.

Hospital care of subjects

The patients included in this survey will be treated according to actual guidelines. Briefly, will be enrolled patients who underwent primary angioplasty within 6 hours after symptoms onset, were introduced antiplatelet and anticoagulation therapy at the correct dose, respectively Acetylsalicylic Acid (ASA) 200 mg and Clopidogrel 300 mg, and enoxaparin 30 mg. In patients without contraindication, it will be administered in the first 24 hours beta-blockers and ACEi in those with ejection fraction (EF) \<0.4, previous MI or prior heart failure. Upon admission, if there is no contraindication, simvastatin 40 mg/day will be administered. As a maintenance dose, the investigators will administer ASA 100 mg, clopidogrel 75 mg, enoxaparin 1 mg/kg twice daily, simvastatin 40 mg, propranolol 40 mg or metoprolol 50 mg (beta-blockers available at the hospital) and captopril 25 mg (most used ACEi). Patients will be treated preferably in the Coronary Unit (CU). Researchers may suggest the physician responsible for the patient care to prescribe the above medications, as well as question why the drugs listed in the guidelines are not being used. The reasons and specific contraindications will be recorded.

The researchers are not directly responsible for the treatment of individuals, which does not absolve them of responsibility for any adverse effects related to the experiments. Also, the investigators emphasize that the study did not interfere with the flow of patients during hospitalization, i.e., will not influence the discharge of patients.

Randomization to one of the three clamps

As observed, the investigators will evaluate endothelial reactivity by FMD. On the day of the clamp, after fasting, they will be exposed to one of three situations: (i) hyperglycemia / hypoinsulinemia, (ii) euglycaemia / hyperinsulinemia and (iii) hyperglycemia / hyperinsulinemia.

The clamps will simulate the possible attenuation or increase in endothelial reactivity promoted by the independent variables during ischemia/reperfusion (I/R) injury. In total, the test will consist of realization of a basal FMD-1 (during 15 minutes), clamps (variable length, usually 60 minutes), FMD-2 (15 min) after the clamp, rest time (30 min), ischemia/reperfusion (20 min) injury, rest time (15 min) and FMD-3 (15 min). Throughout the experiment, blood glucose and insulin will be controlled and maintained at levels such as designed previously for each clamp situation. In all subjects, plasma samples will be collected before the start of the clamp (during FMD-1), at the end of the measurement of the second FMD during the clamp, prior to the I/R injury and 15 minutes after the end of the same test (during FMD-3). In these samples will be dosed insulin, glucose, C-peptide, C-reactive protein, tumor necrosis factor-α (TNF-α), nitric oxide, intercellular adhesion molecule-1 (ICAM-1), plasminogen activator inhibition-1 (PAI-1), isoprostane and interleucin-1 (IL-1).

In one group, the euglycemic/hyperinsulinemic consists of a situation in which insulin levels are above physiological levels and blood glucose levels maintained at approximately 100 mg/dL. Euglycemic/hyperinsulinemic clamp is similar to the way the hyperinsulinemic/hyperglycemic clamp is performed, although reaching a glucose level of approximately 150 mg/dL. During the clamp with hypoinsulinemia/hyperglycemia, will be infused a somatostatin analogue (octreotide) for 30 minutes (t = 0 min) and subsequently infusion of 20% glucose to achieve glycaemia of approximately 150 mg/dL (t = 30 min).

Ischemia/Reperfusion Injury The I/R injury is intended to simulate at the brachial artery a condition similar to coronary lesion resulting from infarction after reperfusion. This experiment will be performed 30 min after the measurement of FMD-2, positioning a pneumatic cuff at level of brachial artery, inflating it to 200 mmHg for 15 minutes. After this period of ischemia, the cuff is deflated and is subsequently performed the brachial reactivity test. This ischemia period is safe, as shown in other studies.

Statistical analysis Data will presented as mean ± standard deviation (SD) when normally distributed or median and interquartile range (IQR) for non-normal data. Categorical variables will be compared by chi-square. Continuous variables with normal distribution will be compared using analysis of covariance (ANCOVA) adjusted for age, gender, size of MI estimated by peak CK-MB and estimated by heart rate variability sympathetic activity. Prerequisites for the ANCOVA models (linearity, normality and equal variance) will be checked using histograms, normal probability plots and residual dispersion. Non-normal continuous variables may be transformed logarithmically. If, after the transformation, they persist not normal, will be analyzed by the Kruskal-Wallis test. Analysis will be performed using the SPSS 22 application, Mac version.

The Influence of Glycaemia and Insulinemia on Vasomotor Endothelial Function After Myocardial Infarction

Influence of Glycaemia and Insulinemia on Vasomotor Endothelial Function After Ischemia/Reperfusion Lesion on Patients in Acute Phase of ST Segment Elevation Myocardial Infarction (STEMI)

Compare the effects of euglycemic/hyperinsulinemic, hyperglycemic/hypoinsulinemic and hyperglycemic/hyperinsulinemic on endothelial reactivity, measured by flow mediated dilation, after ischemia/reperfusion injury assessed at brachial artery.

Compare the effects of euglycemic/hyperinsulinemic, hyperglycemic/hypoinsulinemic and hyperglycemic/hyperinsulinemic on nitric oxide generation before and after ischemia/reperfusion injury assessed at brachial artery.

Compare the effects of euglycemic/hyperinsulinemic, hyperglycemic/hypoinsulinemic and hyperglycemic/hyperinsulinemic on markers of inflammatory activity (CRP, TNF alpha, IL-1 beta and IL-10) in after ischemia/reperfusion injury assessed at brachial artery.

Compare the effects of euglycemic/hyperinsulinemic, hyperglycemic/hypoinsulinemic and hyperglycemic/hyperinsulinemic on markers of endothelial activation (ICAM-1, VCAM-1, PAI-1) in after ischemia/reperfusion injury assessed at brachial artery.

Compare the effects of euglycemic/hyperinsulinemic, hyperglycemic/hypoinsulinemic and hyperglycemic/hyperinsulinemic on markers of oxidative stress (nitrotyrosine and 8-isoprostane) before and after ischemia/reperfusion injury assessed at brachial artery

University of Campinas, Brazil

Assistent Professor, Cardiology Division

Neoplasms

Mouth and Tooth Diseases

Head and Neck Neoplasms

Xerostomia

Salivary Gland Diseases

Mouth Diseases

Stomatognathic Diseases

Herbal and Botanical

Thyme

oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. (Charalambous et al.,2017)

oral rinses with saline 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy.

thyme honey mouth rinse

saline mouth rinse 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy

saline mouth rinse

Susan Seif, professor

Xerostomia is the most frequent complication among patients who receive radiotherapy (RT) . The prevalence of xerostomia has been reported to be from 73.5% to 93% (Kakoei S.,2012). Damage to normal tissues can result by radiotherapy as it is not selective to cancer cells, and so affecting the quality of life of patients. Honey is one of the methods studied by CIM for management of HNC treatment side effects due to its properties. (Brennan et al., 2002; Clarkson et al., 2007; Furness et al., 2011;Hackett et al., 2015).

Thyme honey is a new alternative for management of xerostomia, which is a propolis gel product. Thyme honey is a variety of monofloral honey made from the nectar and pollen of thyme flowers. It has a strong antioxidant, antibacterial, antifungal and immuno modulating health effects. Due to the high sugar concentration in honey, it is believed that its presence in the oral cavity has a sialogogue effect, stimulating the salivary glands to produce saliva.

28 post radiation cancer patients were randomly assigned into two equal groups.The intervention group will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day starting in the 4th week of radiotherapy and for one month after completion of radiotherapy. Patients in the control arm followed the same protocol with normal saline rinses. The treatment assessment of subjective dry mouth score, objective dry mouth score, salivary Ph and salivary flow rate will be carried out at baseline, 2 weeks and one month after starting of the treatment protocol (Charalambous et al., 2017).

Nitric oxide levels will be measured at baseline and after one month of treatment (Abadi et al., 2020).

Effectiveness of Thyme Honey in Management of Xerostomia in Post Radiation Cancer Patients

Effectiveness of Thyme Honey in Management of Xerostomia in Post Radiation Cancer Patients A Randomized Controlled Clinical Trial With a Biochemical Assessment

Q1. Do you feel dryness in your mouth ? Q2. Do you drink liquids to help you swallow dry food? Q3. Do you feel mouth dryness when eating a meal? Q4. Does the saliva seem to be too little in your mouth? Subjects who answered confirmatively to at least one of those questions related to dry mouth will be considered as positive for oral dryness subjective complaints.

Objective dry mouth score:

The patients will be examined for their signs of dry mouth including:

(Osailan et al., 2011).

1. pooled saliva loss
2. stickiness of mouth mirror to buccal mucosa
3. stringy or foamy appearance of saliva
4. dehydration of the lips
5. no response to parotid stimulation Calculation of Objective dry mouth scores will be according to the number of dry mouth signs observed (0-5) and patients with less than 2 score will be excluded

identification of PH according to the color of the PH paper

assessment of nitric oxide levels in the salivary samples using ELISA

assessing unstimulated salivary flow rate in 5 minutes

Ain Shams University

teaching assistant of oral medicine and periodontology

Respiratory Tract (Lung and Bronchial) Diseases

Wounds and Injuries

Lung Neoplasms

Pneumonia

Radiation Pneumonitis

Lung Diseases

Respiratory Tract Diseases

Lung Diseases, Interstitial

Lung Injury

Radiation Injuries

Esophageal Cancer

Nitric Oxide Breath Test + Questionnaires

Breathe out into a device (nitric oxide breath analyzer) for 10 seconds; repeated 3 times. Done prior to start of radiation therapy, 1 week before completion of radiation therapy, at completion of radiation therapy, then at each follow-up visit for 6 months.

Nitric oxide breath test

On day of each breathing test, completion of a breathing and symptom questionnaire, approximately 10 minutes.

Questionnaires

Thomas Guerrero, MD, PHD

The goal of this clinical research study is to learn if the level of nitric oxide you breathe out may relate to the amount of breathing complications that you may experience due to radiation treatment.

Nitric Oxide Breathing Test:

If you agree to take part in this study, you will have a nitric oxide breathing test performed before, during and after radiation therapy. You will you will have a nitric oxide breathing test 1 week before you complete radiation therapy, when you complete radiation therapy, and at each follow-up visit for 6 months.

To complete this test, you will breathe out into a device called a nitric oxide breath analyzer for 10 seconds. You will repeat this test 3 times. The results of this test will give researchers information about possible inflammation in your lungs. The results of this test will be compared with any breathing symptoms you may experience during the same time period.

For your first breath testing session and any session when your nitric oxide level is at least 1 ½ times higher than the first session, you will repeat the test for up to 5 different "breathe out rates". This additional testing will allow the researchers to find where in your lungs the nitric oxide increase is coming from.

Breathing Symptoms Questionnaire:

On the day of each breathing test, you will complete a questionnaire about your breathing and any symptoms you may be experiencing. This should take about 10 minutes. After radiation therapy is complete, some of the monthly questionnaires will be completed by the data coordinator using telephone interviews.

Length of Study:

Your participation in this study will be over after you complete the last breath testing session.

This is an investigational study. The nitric oxide breath analyzer used in this study is FDA approved and commercially available for measuring breathed out nitric oxide levels in patients with asthma. Its use to predict lung inflammation caused by radiation therapy is investigational.

Up to 150 patients will take part in this study. All will be enrolled at MD Anderson.

Phase II Evaluation of Exhaled Nitric Oxide (NO)

Phase II Evaluation of Exhaled Nitric Oxide as a Predictive Biomarker for Radiation Pneumonitis

Ratio between weekly and baseline nitric oxide measurements in participants receiving thoracic radiation therapy. Exhaled nitric oxide measured in triplicate on a weekly basis during radiotherapy and on each follow-up visit.

National Institutes of Health (NIH)

M.D. Anderson Cancer Center

Keratosis, Actinic

Keratosis

Lichen Planus, Oral

Lichen Planus

Mouth Neoplasms

Leukoplakia

Leukoplakia, Oral

Precancerous Conditions

Lichenoid Eruptions

Exanthema

Skin Diseases, Papulosquamous

Pathological Conditions, Anatomical

Oral Cancer

Lip and Oral Cavity Cancer

Oral Leukoplakia

Analgesics

Central Nervous System Depressants

Nitrous Oxide

salivary biomarker

weam Elbattawy, Phd

investigating the level of malondialdehyde (MDA) \& nitric oxide (NO) in saliva in oral premalignant and malignant lesions in order to determine their diagnostic value for the malignant and potentially malignant lesions.

Being a detrimental disease, cancer development is a very complicated process that requires many sequential steps and depends on a various number of genetic alterations and factors(1). Among these factors are the free radicals which are derived either from endogenous or exogenous sources (5). Free radicals result in an oxidative stress of the affected cells generating a body imbalance between oxidants and antioxidants (6).

In this regard, saliva has been currently used to assess this possible oxidative imbalance through various salivary biomarkers including nitric oxide (NO) and malondialdehyde (MDA). Saliva could be used as a very interesting rich medium, known for its role in diagnosis, prognosis and treatment that has become more prominent in oral diseases (6).

Nitric oxide (NO) is an intercellular messenger molecule having many important biological functions. The levels of nitric oxide in salivary secretions could be used to monitor the severity of many underlying disease processes. Moreover, malondialdehyde (MDA) has been the most frequently used biomarker of oxidative stress in many pathological conditions such as cancer. It resulted from reactive oxygen species lipid degradation and induced toxic stress in affected cells, making both biomarkers a point of focus in monitoring clinical progress of suspected lesions

Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions

all the data will shared once the work is published

The MDA level in saliva measured using ELISA kit provided by My BioSource, USA.

The nitric oxide level in saliva measured using ELISA kit provided by My BioSource, USA.

Beni-Suef University

principle investigator

Neoplasm Metastasis

Neoplastic Processes

Subjects will receive the RP2D dose of NO

Nitric Oxide 25,000 ppm

Nitric Oxide 50,000 ppm

Nitric Oxide 100,000 ppm

Intratumoral injection of selected does on gNO

Nitric Oxide selected dose

Edith Dekel

Yaara Ber, PhD

David Greenberg, MD

This is a Phase 1, open-label, dose-escalation and dose-expansion study comprised of a screening period, a single treatment session, an evaluation period of 21±3 days, and safety and survival follow-up period of up to 12 weeks post-treatment.

The purpose of this Phase 1 study is to initiate clinical development of gNO in patients with unresectable cutaneous or subcutaneous primary or metastatic solid tumors that are not amenable or have failed standard treatment, for which no therapy of proven efficacy exists, or which has progressed despite standard therapy. This study of gNO treatment will consist of 2 parts: a dose-escalation part to establish a safe and tolerable dose of gNO in patients with primary or metastatic unresectable cutaneous or subcutaneous solid tumors (Part A), and a dose expansion phase (Part B) which may be initiated at the Sponsor's discretion after the maximum tolerated dose (MTD) and/or optimal biological dose (OBD) (or recommended Phase 2 dose \[RP2D\]) has been determined in the dose-escalation phase (Part A). This study will be the basis for future studies.

In Part A, the following gNO doses will be studied to determine MTD and/or OBD: 25,000 ppm, 50,000 ppm and 100,000 ppm. Additional dose levels may be evaluated based on the emerging data as determined by the Safety Review Committee.

Once the MTD and/or OBD is determined, additional patients will be treated in Part B Dose Expansion to further characterize the safety and biomarkers of gNO and determine RP2D.

A Study to Assess the Safety and Efficacy of Nitric Oxide Injection Into Unresectable Solid Primary or Metastatic Tumors

A Phase 1, Open-Label, Dose Escalation and Dose Expansion Study to Assess the Safety and Efficacy of Nitric Oxide Injection Into Unresectable Solid Cutaneous/Subcutaneous Primary or Metastatic Tumors

Measurement of blood immune biomarkers levels

The incidence and characteristics of adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs) and changes in assessed safety parameters. Toxicity will be graded according to NCI CTCAE version 5.0

The anti-tumor activity of a single intratumoral gNO injection will be measured per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and secondarily immune-related RECIST (iRECIST).

Beyond Air Inc.

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

RRx-001

Jeffrey Infante, MD

Tony Reid, MD

The purpose of this study is to evaluate the safety and pharmacokinetic profile of RRx-001 for injection in subjects with advanced solid tumors or lymphomas for which there are no currently accepted curative therapies. This study will also conduct an exploratory evaluation of objective tumor response using CT or MRI.

The DINAMIC (DINitroazetidines As Medications In Cancer) trial represents a provascular approach to temporarily change tumor blood flow and oxygenation. Blood supply to most tumors is poor, causing parts of tumors to have a low oxygen content which promotes aggressiveness and metastasis. The DINAMIC trial uses specific imaging techniques (including ultrasound), biopsy, and breath analysis to provide an early assessment of therapeutic activity.

Safety and Pharmacokinetic Study of RRx-001 in Cancer Subjects

A Phase I, Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of RRx-001 in Subjects With Advanced Solid Tumors or Lymphomas For Which There Are No Currently Accepted Curative Therapies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nitric Oxide Releasing Solution (NORS) For The Treatment Of Human Papillomavirus(HPV) Verrucae Plantaris (Plantar Warts)	NCT05877313	Verruca Plantar...	Sterile water f... Nitric Oxide	12 Years -	Sanotize Research and Development corp.
The Influence of Glycaemia and Insulinemia on Vasomotor Endothelial Function After Myocardial Infarction	NCT02250989	Myocardial Infa...		40 Years - 70 Years	University of Campinas, Brazil
Effectiveness of Thyme Honey in Management of Xerostomia in Post Radiation Cancer Patients	NCT05859711	Head and Neck C...	thyme honey mou... saline mouth ri...	25 Years - 65 Years	Ain Shams University
Phase II Evaluation of Exhaled Nitric Oxide (NO)	NCT01392144	Lung Cancer	Nitric oxide br... Questionnaires	18 Years -	M.D. Anderson Cancer Center
Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions	NCT04267419	Oral Lichen Pla... Oral Cancer Leukoplakia Oral Keratoses	salivary biomar...	18 Years - 70 Years	Beni-Suef University
Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions	NCT04267419	Oral Lichen Pla... Oral Cancer Leukoplakia Oral Keratoses	salivary biomar...	18 Years - 70 Years	Beni-Suef University
A Study to Assess the Safety and Efficacy of Nitric Oxide Injection Into Unresectable Solid Primary or Metastatic Tumors	NCT05351502	Cancer	Nitric Oxide 25... Nitric Oxide 50... Nitric Oxide 10... Nitric Oxide se...	18 Years -	Beyond Air Inc.
Phase II Evaluation of Exhaled Nitric Oxide (NO)	NCT01392144	Lung Cancer	Nitric oxide br... Questionnaires	18 Years -	M.D. Anderson Cancer Center
Nitric Oxide Releasing Solution (NORS) For The Treatment Of Human Papillomavirus(HPV) Verrucae Plantaris (Plantar Warts)	NCT05877313	Verruca Plantar...	Sterile water f... Nitric Oxide	12 Years -	Sanotize Research and Development corp.
Safety and Pharmacokinetic Study of RRx-001 in Cancer Subjects	NCT01359982	Malignant Solid... Lymphomas	RRx-001 RRx-001 RRx-001 RRx-001 RRx-001 RRx-001	18 Years -	EpicentRx, Inc.
PMRR-NO: Pulmonary Metabolic Radiation Response Versus Exhaled Nitric Oxide	NCT00867477	Gastrointestina... Esophageal Canc... Lung Cancer	Breathing Test Respiratory Sym... Pet Scan	-	M.D. Anderson Cancer Center
The Influence of Glycaemia and Insulinemia on Vasomotor Endothelial Function After Myocardial Infarction	NCT02250989	Myocardial Infa...		40 Years - 70 Years	University of Campinas, Brazil

Spots Global Cancer Trial Database for nitric oxide

Every month we try and update this database with for nitric oxide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.