Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Breast Neoplasms

Liver Cirrhosis

Fibrosis

Liver Diseases

Gastrointestinal Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Anti-Arrhythmia Agents

Cardiotonic Agents

Lipid Regulating Agents

Natriuretic Agents

Hematinics

Anti-Infective Agents

Antineoplastic Agents

Bone Density Conservation Agents

Metformin

Digoxin

Rosuvastatin Calcium

Furosemide

Liver Extracts

polysaccharide-K

Calcium

Calcium, Dietary

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Enzyme Inhibitors

Diuretics

Sodium Potassium Chloride Symporter Inhibitors

Protective Agents

Every participant receives a cocktail of Rosuvastatin, Digoxin, Metformin hydrochlorid, Furosemide.

Every participant receives a cocktail of Rosuvastatin, Digoxin, Metformin hydrochlorid, Furosemide.

Compensated=without any disease symptoms

Every participant receives a cocktail of Rosuvastatin, Digoxin, Metformin hydrochlorid, Furosemide.

Decompensated= with disease symptoms like aszites, variceal bleeding, hepatic encephalopathy, hepato-renal syndrome

Rosuvastatin

Metformin hydrochlorid

Boehringer Ingelheim

The main trial objective, is to ascertain whether the transport activity, given by the maximum concentration (Cmax) and the area under the curve (AUC0-24) values for the different components in the transporter cocktail are similar or different in F4 liver cirrhosis patients on standard therapy compared to healthy subjects.

A Study to Compare How Different Medicines (Rosuvastatin, Digoxin, Metformin, and Furosemide) Are Handled by the Body of Healthy People and People With Liver Cirrhosis

Transporter Profiling Study for P-glycoprotein 1 (P-gp), Organic Anion Transporter 1 (OAT1), Organic Anion Transporter 3 (OAT3), Organic Cation Transporter 2 (OCT2), Multidrug and Toxin Extrusion Protein 1 (MATE1), Multidrug and Toxin Extrusion Protein 2-K (MATE2-K), Organic Anion Transporting Polypeptide 1B1 (OATP1B1), Organic Anion Transporting Polypeptide 1B3 (OATP1B3) and Breast Cancer Resistance Protein (BCRP) in Healthy Subjects and in Patients With Stage 4 (F4) Liver Fibrosis / Cirrhosis.

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g., studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https:// www.mystudywindow.com/msw/datatransparency

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antirheumatic Agents

Anticonvulsants

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Acetazolamide

Mesna

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Carbonic Anhydrase Inhibitors

Participants will receive chemotherapy to prepare your body for the study drug combination, then you will receive OBX-115 and acetazolamide.

OBX-115

Fludarabine Phosphate

Rodabe N Amaria, MD

The goal of this clinical research study is to find the recommended dose of OBX-115 in combination with acetazolamide that can be given to patients with metastatic melanoma previously treated with immune checkpoint inhibitors. The safety and tolerability of the study drug combination will also be studied.

Primary Objective:

• Assess the safety and tolerability of OBX-115 + acetazolamide by CTCAE version 5 criteria to provide a recommended Phase II dose

Secondary Objectives:

* Assess preliminary efficacy of OBX-115 + acetazolamide cell therapy in patients with immune checkpoint inhibitor (ICI)-relapsed and/or refractory metastatic melanoma by evaluating overall response rate (ORR; complete response \[CR\] + partial response \[PR\]) by RECIST 1.1 criteria
* Evaluate feasibility of the manufacturing process
* Evaluate duration of response (DOR)
* Evaluate progression free survival (PFS)
* Characterize in vivo cellular kinetics of OBX-115 cells in tumor and/or in peripheral blood by polymerase chain (PCR) and/or fluorescence-activated cell sorting (FACS) analyses
* Characterize the pharmacokinetic profile of acetazolamide when administered in combination with OBX-115
* Characterize the incidence and prevalence of OBX-115 therapy immunogenicity

Exploratory Objectives:

* Assess relationship of soluble immune factors and pharmacodynamic markers, with cellular kinetics, safety, and efficacy
* Describe the composition of OBX-115 subsets (immunophenotyping in peripheral blood mononuclear cells \[PBMCs\] and in tumor), summarized by clinical response
* Explore the correlation of OBX-115 kinetics in tumor and peripheral blood with clinical endpoints
* Explore the correlation of immune checkpoints with OBX-115 cellular kinetics and efficacy
* Evaluate overall survival (OS)

Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma

M.D. Anderson Cancer Center

Blood and Lymph Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Leukemia

Dyspnea

Hypoxia

Edema

Dilatation, Pathologic

Pulmonary Edema

Hematologic Diseases

The first portion of this study is an open label pilot experience to evaluate the safety of aquapheresis in leukemia patients with severe fluid overload non-responsive to diuretics. A total of 10 patients will be treated.

Participant connected to aquapheresis pump through an intravenous (IV) catheter placed in forearm. About 6 teaspoons of blood will flow through the blood circuit, and the excess fluid will slowly be collected in the collection bag. The exact length of time of aquapheresis treatment is determined by how much fluid needs to be removed and how fast it can be removed. The average treatment is about 24 hours but can extend up to 7 days. About 6 liters or 13 pounds will be removed.

Furosemide by vein over about 15 minutes every 8 hours or by vein as a continuous (non-stop) infusion.

Participant connected to aquapheresis pump through an intravenous (IV) catheter placed in forearm. Average treatment is about 24 hours but can extend up to 7 days.

Aquapheresis

20-40 mg by vein every 8 hours as indicated for optimal diuresis to achieve negative fluid balance or 0.5 to 5 mg per hour by continuous infusion.

Gloria Iliescu, MD

The goal of this clinical research study is to learn about the safety and level of effectiveness of aquapheresis compared to diuretic drugs. Diuretic drugs are designed to help the kidneys to form more urine. They also remove fluids from patients with severe fluid overload who have not responded to diuretics.

Aquapheresis is a procedure that removes excess fluid from the body. Blood containing too much salt and water is withdrawn from the body using catheters (sterile flexible tubes) and passed through a special filter. The filter separates the excess salt and water from the blood. The blood is returned to the patient and the fluid is collected in a bag to be disposed. Aquapherisis may benefit patients by removing excess fluid and salt from the body.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. The first group of 10 participants to join the study will be enrolled in the Pilot portion of the study. The next group of up to 40 participants will be enrolled in the Randomized portion of the study.

In the Pilot portion of the study, researchers want to learn about the safety and level of effectiveness of aquapheresis in leukemia patients with severe fluid overload who do not respond to diuretics.

If you are in the Randomized portion of the study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being assigned to each group.

* Group A will receive aquapheresis.
* Group B will receive furosemide. The doctor will discuss this with you.

If you are in Group A, you will be connected to the aquapheresis pump through an intravenous (IV) catheter placed in your forearm. The pump looks like the ones used to infuse IV drugs. It will hang on a pole by your bed. About 6 teaspoons of your blood will flow through the blood circuit, and the excess fluid will slowly be collected in the collection bag. The exact length of time of aquapheresis treatment is determined by how much fluid needs to be removed and how fast it can be removed. The average treatment is about 24 hours but can extend up to 7 days. About 6 liters or 13 pounds will be removed.

If you are in Group B, you will receive one of the following for as the doctor thinks it is needed (until most of the excess fluid is removed):

* furosemide by vein over about 15 minutes every 8 hours
* furosemide by vein as a continuous (non-stop) infusion

Both Groups:

If the doctor thinks it is needed, you will be given other standard of care drugs such as albumin and metolazone to help your kidneys to make more urine. The study staff will tell you about these drugs, how they will be given, and the possible risks.

Study Visits:

Every day while you are receiving aquapheresis or diuretic treatment:

* You will be asked about any symptoms you may be having.
* You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, and breathing rate) and weight.
* You will be asked how much you drank. The study staff will measure how much you urinate.
* Your leg will be measured for swelling due to fluid retention.

At least every other day, blood (about 4 teaspoons) will be drawn for routine tests.

If the doctor thinks it is needed, you will have a chest x-ray on Day 3.

Length of Participation:

If you are in Group A, you will remain on study treatment for as long as the doctor thinks it is needed (possibly about 1-7 days).

If you are in Group B, you will receive standard treatment for as long as your doctor thinks it is needed.

You will no longer be able to receive the study treatment (Group A) or you will be taken off study (Group B) if intolerable side effects occur or if you are unable to follow study directions.

Your participation on the study will be over once you have completed the end-of-study follow-up visit.

End-of-Treatment Visit:

After you stop taking the study treatment or standard treatment, the following tests and procedures will be performed:

* You will be asked about any symptoms you may be having.
* You will have a physical exam, including measurement of your vital signs and weight.
* You will be asked how much you drank. The study staff will measure how much you urinate.
* Your leg will be measured for swelling due to fluid retention.
* Blood (about 4 teaspoons) will be drawn for routine tests.
* If the doctor thinks it is needed, you will have a chest x-ray.

End-of-Study Follow-up Visit:

At 30 days after the end of study therapy:

* You will have a physical exam, including measurement of your vital signs and weight.
* You will be asked about any symptoms you may be having.
* Your leg will be measured for swelling due to fluid retention.

This is an investigational study. The Aquadex FlexFlow™ Fluid Removal Systems pump used for aquapheresis is FDA approved and commercially available for patients with fluid overload. Using the Aquadex FlexFlow™ Fluid Removal Systems pump in patients with leukemia to remove excess fluid is investigational. Furosemide is FDA approved and commercially available for other uses such as the treatment of swelling caused by heart failure or kidney or liver problems.

Up to 50 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Ultrafiltration (Aquapheresis) in Patients With Leukemia and Severe Fluid Overload

Ultrafiltration (Aquapheresis) in the Management of Patients With Leukemia and Severe Fluid Overload

Primary end point is success rate defined as achievement of weight loss of 7 pounds or 50% of weight gain, whichever is greater without \>/=100% increase of baseline creatinine at 72 hours.

Complete response defined as achievement of 80% removal of fluid overload compared to dry body weight (average body weight before being sick and hospitalized) without ≥100% increase of baseline creatinine at 72 hours.

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Warts

Communicable Diseases

Papillomavirus Infections

Virus Diseases

DNA Virus Infections

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

CLS003

Vehicle topical

J. (Koos) Burggraaf, MD, PhD

A phase 2, randomized, vehicle-controlled, double-blind study to assess the efficacy, safety and pharmacodynamics (PD) of topically applied CLS003 in otherwise healthy patients with cutaneous warts.

A Phase 2 Efficacy Study of CLS003 ICVT in Subjects With Cutaneous Warts.

A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Study to Evaluate Efficacy and Safety of Topical Ionic Contra-viral Therapy (ICVT) Comprised of CLS003 in Cutaneous Warts

Maruho Co., Ltd.

Prostatic Neoplasms

Carcinoma

Adenocarcinoma

Recurrence

Disease Attributes

Fluorides

Patients receive F-18 rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study.

F18-rhPSMA-7.3

Positron Emission Tomography

Computed Tomography

Charles V. Marcus, MBBS

This phase II trial evaluates Fluorine-18 radiohybrid prostate-specific membrane antigen (18F- rhPSMA)-7.3 positron emission tomography (PET)/computed tomography (CT) scans with and without furosemide for the reduction of bladder activity in patients with prostate cancer that has come back (recurrent) based on elevated levels of prostate-specific antigen (PSA) in the blood (biochemical) after prostate surgery (prostatectomy). Furosemide is a diuretic substance that increases the urine flow into the bladder, thereby decreasing the level of radioactivity within the bladder, which may help to see any abnormal areas that could be masked by the radioactivity within the bladder. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, rhPSMA ligand. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Adding furosemide to 18F-rhPSMA 7.3 PET/CT scans may help to better detect and treat patients with biochemically recurrent prostate cancer.

PRIMARY OBJECTIVE:

I. To determine if administering 20 mg furosemide intravenously (IV) at the time of radiotracer injection significantly reduces bladder activity compared with the same patient scanned without furosemide as internal control.

SECONDARY OBJECTIVES:

I. To compare detection rates of recurrent disease in blinded interpretations between the furosemide and non-furosemide 18FrhPSMA-7.3 PET/CT scans, with patients serving as their own internal controls.

II. To compare reader confidence in identifying prostate bed and other recurrent lesions on a 18F-rhPSMA-7.3 PET/CT with furosemide compared with 18F-rhPSMA-7.3 PET/CT without furosemide.

OUTLINE:

Patients receive 18F-rhPSMA 7.3 tracer IV and then undergo PET-CT scans with and without furosemide IV on study.

Comparison of 18F-rhPSMA-7.3 PET/CT With and Without Furosemide in Biochemical Recurrence of Prostate Cancer

Strategy to Reduce Bladder Activity With RhPSMA 7.3: Comparison of 18F-RhPSMA 7.3 PET/CT With and Without Furosemide in Biochemical Recurrence of Prostate Cancer

Change in bladder SUV mean will be assessed using a paired t-test, or using a non-parametric equivalent such as a Wilcoxon signed rank test. Descriptively, change in bladder SUV mean will be reported for those administered 20 mg furosemide intravenously (IV) at the time of radiotracer injection first (group A), and those administered 20mg furosemide IV at the time of radiotracer injection second (group B).

Change in bladder and renal activity will be assessed using paired t-tests, or using non-parametric equivalents such as a Wilcoxon signed rank tests. Descriptively, bladder and renal activity will be reported for those administered 20 mg furosemide IV at the time of radiotracer injection first (group A), and those administered 20 mg furosemide IV at the time of radiotracer injection second (group B).

Defined as presence of unequivocal soft tissue radiotracer uptake that is characteristic of malignancy in the prostate bed and/or surrounding soft tissues and within pelvic lymph nodes. Recurrent disease rates will be compared (furosemide versus non-furosemide flotufolastat F-18 radiohybrid prostate-specific membrane antigen (18F-rhPSMA)-7.3 positron emission tomography (PET) scans using McNemar's tests. Rates will be reported, along with 95% exact confidence intervals using the Clopper-Pearson method. Descriptively, recurrent disease rate will be reported for those administered 20 mg furosemide IV at the time of radiotracer injection first (group A), and those administered 20 mg furosemide IV at the time of radiotracer injection second (group B).

The readers' confidence in identifying prostate bed, pelvic and retroperitoneal nodal disease and other recurrence on 18F-rhPSMA-7.3 PET/computed tomography (CT) with furosemide compared with the 18F-rhPSMA-7.3 PET/CT without furosemide will be scored using a 5-point Likert scale. This analysis will be descriptive, with summary statistics reported with and without furosemide. Continuous variables will be summarized using mean, median, interquartile range, standard deviation, and min/max. Categorical variables will be summarized using frequencies and percentages. All tests will be two-sided with an alpha level of 0.05, unless otherwise noted. Statistical analysis will be conducted using SAS 9.4.

National Cancer Institute (NCI)

Blue Earth Diagnostics

Emory University

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Compare How Different Medicines (Rosuvastatin, Digoxin, Metformin, and Furosemide) Are Handled by the Body of Healthy People and People With Liver Cirrhosis	NCT05741372	Liver Cirrhosis	Rosuvastatin Digoxin Metformin hydro... Furosemide	18 Years - 75 Years	Boehringer Ingelheim
Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma	NCT05470283	Tumor Metastatic Mela... Melanoma	OBX-115 Acetazolamide Cyclophosphamid... Furosemide Mesna Fludarabine Pho...	18 Years -	M.D. Anderson Cancer Center
Ultrafiltration (Aquapheresis) in Patients With Leukemia and Severe Fluid Overload	NCT01508260	Leukemia	Aquapheresis Furosemide	18 Years -	M.D. Anderson Cancer Center
A Phase 2 Efficacy Study of CLS003 ICVT in Subjects With Cutaneous Warts.	NCT02333643	Cutaneous Warts	CLS003 Furosemide Digoxin Vehicle topical	18 Years - 65 Years	Maruho Co., Ltd.
Comparison of 18F-rhPSMA-7.3 PET/CT With and Without Furosemide in Biochemical Recurrence of Prostate Cancer	NCT05779943	Prostate Adenoc... Recurrent Prost...	Furosemide F18-rhPSMA-7.3 Positron Emissi... Computed Tomogr...	18 Years -	Emory University
A Phase 2 Efficacy Study of CLS003 ICVT in Subjects With Cutaneous Warts.	NCT02333643	Cutaneous Warts	CLS003 Furosemide Digoxin Vehicle topical	18 Years - 65 Years	Maruho Co., Ltd.
Comparison of 18F-rhPSMA-7.3 PET/CT With and Without Furosemide in Biochemical Recurrence of Prostate Cancer	NCT05779943	Prostate Adenoc... Recurrent Prost...	Furosemide F18-rhPSMA-7.3 Positron Emissi... Computed Tomogr...	18 Years -	Emory University
A Study to Compare How Different Medicines (Rosuvastatin, Digoxin, Metformin, and Furosemide) Are Handled by the Body of Healthy People and People With Liver Cirrhosis	NCT05741372	Liver Cirrhosis	Rosuvastatin Digoxin Metformin hydro... Furosemide	18 Years - 75 Years	Boehringer Ingelheim

Spots Global Cancer Trial Database for furosemide

Every month we try and update this database with for furosemide 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.

Spots Global Cancer Trial Database for furosemide

Every month we try and update this database with for furosemide 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.

Every month we try and update this database with for furosemide 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.