Treatment Trials

98 Clinical Trials for Various Conditions

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EnSeal Efficacy and Bursting Pressure in Human Vessels
Description

In this study the investigators will include adult patients who are not part of a vulnerable patient population. Inclusion criteria include patients who will be undergoing resection of part of their colon that will require dividing the IMA. The investigators will use the resected surgical specimens for our project. The investigators will use the EnSeal on all major vessels in our procedure. The investigators will use the EnSeal 5 mm round head model. Due to the nature of the project, we will apply for IRB approval prior to beginning our research. The investigators plan to include 60 total patients in the study, 30 at the University of Illinois and 30 at Lutheran General Hospital. Prior to resection, the investigators will use a sterile caliper to take an in-vivo measurement of the IMA and IMV. Immediately after resection, the investigators will remove the sealed proximal end of the IMA and the 3 cm distal to it from the surgical specimen. The investigators will similarly prepare the IMV. The investigators will inspect our vessels for any iatrogenic traumatic tears. If the vessels are suitable, the investigators will then gentle apply manual traction to remove any blood or clots within the lumen. The investigators will measure the outer diameter of the vessels using a digital caliper. If there are small branches, the investigators will tie them off with suture. The unsealed end will then be attached to the burst pressure tester with suture and it will be tested for the bursting pressure. The device measures pressure continuously as it infuses the segment with normal saline at a steady rate (50 ml/hr). A leak will be determined by a decrease in intra-luminal pressure of 100 mm Hg or a visible leak. A failure to seal the vessels will be determined by a bursting pressure of less than 100 mm Hg. It should be noted that each section would only be pressure-tested once. All of our data will be collected on the enclosed data sheet we have created for use in this protocol. The investigators will then place the vessels with the original surgical specimen where it will be submitted for routine pathological examination of surgical specimens. Twenty five specimens at each site will undergo the testing, whereas 5 specimens will be sent to pathology without testing. Our pathologist will analyze the submitted specimen for extent of seal, disruption of vessel smooth muscle, gas bubbles, and will stain for elastin to analyze the disruption in the vessel wall. In addition, the seal will be measured and we will obtain digital images. The specimens submitted for pathology will be 5 burst specimens as well as 5 un-burst specimens taken from the pool of 25 patients at UIC. For our human component, the investigators have estimated the standard deviation and width of the confidence interval to be 100 mm Hg each. With a 95% confidence level, the investigators expect to require 16 measurements for human specimens from 16 patients although the investigators will use 50 patients to allow for errors in obtaining pressures. Our timeline for the completion of the projects is 6 months. The investigators plan on being able to complete the human burst pressure testing within 6 months.

Conditions

Colon and Rectal Diseases

CRC Detection Reliable Assessment With Blood
Description

The CRC DRAW study will assess the sensitivity and specificity of the blood-based, Next-Gen CRC Screening Test for the detection of CRC.

Conditions

Colorectal Cancer, Adenomas Colon, Colon Cancer, Rectal Cancer, Colon Neoplasm, Colon Lesion, Colon Disease, Colon Polyp, Polyps, Adenoma, Rectal Diseases, Rectal Polyp, Gastrointestinal Neoplasms, Intestinal Neoplasms, Colonic Diseases, Functional, Intestinal Disease

Prevention of Colorectal Cancer Through Multiomics Blood Testing
Description

The PREEMPT CRC study is a prospective multi-center observational study to validate a blood-based test for the early detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.

Conditions

Colon Cancer, Rectal Cancer, Colon Neoplasm, Colon Diseases, Colon Lesion, Colon Polyp, Colorectal Cancer, Polyp, Adenoma, Rectal Diseases, Gastrointestinal Tract Cancers

Assessing Infectious Risk and Visceral Closure in Natural Orifice Translumenal Endoscopic Surgery (NOTES)
Description

The purpose of this study is to determine: 1. What quantity of bacteria is spilled into the abdomen during a colon resection 2. If there is a correlation between the quantity and post-operative infection 3. What intralumenal pressure is generated when testing the colonic anastomosis for air leak

Conditions

Colonic Diseases, Rectal Diseases

Random Comparison of LigaSure and Disposable Staples for Laparoscopic Surgery
Description

The purpose of this research is to compare two different standard of care surgical methods for the following large bowel (colon) procedures: laparoscopic right colectomy, total colectomy, and left colectomy. The study will compare electrocautery, used with surgical clips and/or surgical staplers, and the Ligasure vessel sealer. The investigators will be looking at which procedure is faster and more cost efficient and the investigators will calculate hospital expenses for the two groups to make comparisons.

Conditions

Colonic Diseases, Rectal Diseases

A Study to Learn About How Different Amounts of the Study Medicine PF-07826390 Act in the Body of People With Cancer When Taken Alone or With Other Anti-cancer Medicines.
Description

The purpose of this study is to learn about the: * safety (the effect of the study medicine on the participant's body), * effects of the study medicine alone or in combination with sasanlimab - * the best amount of the study medicine. This study is seeking participants who have solid tumors (An abnormal mass of tissue) that: * have advanced (cancer that does not disappear or stay away with treatment) or * are metastatic (has spread to other parts of the body). This includes (but limited to) the following cancer types: * Non-Small Cell Lung Cancer (NSCLC): It's a type of lung cancer where the cells grow slowly but often spread to other parts of the body. * Colorectal Cancer (CRC): This is a disease where cells in the colon or rectum grow out of control. * Renal Cell Carcinoma (RCC): This is a cancer that starts in the kidney. All participants in this study will receive the study medication (PF-07826390) as an IV infusion (given directly into a vein) at the study once every four weeks in 28 day cycles. The study participants depending on the group enrolled in, will receive the study medication (PF-07826390 alone or in combination with other anti-cancer medications (sasanlimab). Sasanlimab is given as a shot under the skin every 4 weeks. Participants can continue to take the study medication (PF-07826390) until their cancer is no longer responding. Participants who are taking sasanlimab may receive it for up to 2 years. The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and effective. Participants will be involved in this study for up to 4 years. During this time, participants will have a study visit every week. The participants after stopping the study medicine (at about 2 years) will be followed for another two years to see how the participants are doing.

Conditions

Neoplasms, Non-small-cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma, Colorectal Carcinoma, Ovarian Carcinoma

Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
Description

This study evaluates the efficacy and safety of a single injection of iltamiocel (300 x 10\^6 cells) compared to a placebo in the reduction of fecal incontinence episode frequency in adult female participants with chronic fecal incontinence and a history of obstetric anal sphincter injury. Half of the participants will receive iltamiocel (injections with cells) and the other half will receive placebo.

Conditions

Fecal Incontinence

A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
Description

The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that: * has spread to other parts of the body (metastatic); * has a certain type of abnormal gene called "BRAF"; and * has not received prior treatment. Participants in this study will receive one of the following study treatments: * Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection into the vein) at the study clinic. * Encorafenib plus cetuximab with chemotherapy: These participants will receive encorafenib and cetuximab in the way described in the bullet above. Additionally, they will receive standard chemotherapy by IV infusion and oral treatment at home. * Chemotherapy alone: These participants will receive chemotherapy, the standard treatment for this condition, by IV infusion at the study clinics and oral treatment at home. This study is currently enrolling participants who will receive either encorafenib plus cetuximab with chemotherapy or chemotherapy alone. The study team will monitor how each participant responds to the study treatment for up to about 3 years.

Conditions

Neoplasms

Colorectal Cancer Screening in a Community Health Setting
Description

This randomized controlled pilot study at the Health Annex, Family Practice \& Counseling Network (FPCN), a community clinic in Southwest Philadelphia, aimed at providing data on the feasibility of a mailed FIT approach to CRC screening in a community health setting, and how patients respond to text messaging and behavioral economic engagement incentives.

Conditions

Cancer of the Colon

Study of GVAX (With CY) and Pembrolizumab in MMR-p Advanced Colorectal Cancer
Description

This study will be looking at the objective response rate (ORR) as measured by RECIST in in patients with mismatch repair-proficient (MMR-p), advanced colorectal cancer that treated with CY/GVAX in combination with Pembrolizumab.

Conditions

Metastatic Colorectal Cancer

A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer
Description

This is an international multi-center, prospective, open-label, randomized, adaptive design phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC).

Conditions

Colorectal Cancer

Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)
Description

The primary objective of this study is to gather stool samples from subjects with inflammatory bowel disease (IBD) to be added to a test set of stool samples that will be utilized to help select molecular markers and determine the optimal sensitivity and specificity values for the Exact IBD-ACRN surveillance test for colorectal cancer (CRC).

Conditions

Inflammatory Bowel Disease, Colorectal Neoplasms, Digestive System Diseases, Colonic Diseases, Colorectal Cancer

Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers
Description

The primary objective of this study is to obtain de-identified, clinically characterized, stool and plasma specimens for use in assessing new markers for the detection of neoplasms of the digestive tract.

Conditions

Colorectal Neoplasms, Digestive System Diseases, Colonic Diseases, Colorectal Cancer

Microbiome Test for the Detection of Colorectal Polyps and Cancer
Description

The purpose if this study is to measure the sensitivity, specificity and accuracy of the Metabiomics Colon Polyp and Colorectal Cancer Assay for the non-invasive detection of colon polyps or colorectal cancer.

Conditions

Colorectal Neoplasms, Colorectal Cancer

SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC)
Description

This study will be looking at whether CY/GVAX in combination with SGI-110 is effective (recruits CD45RO+ T cells to the tumor which may be a marker of anti-tumor activity) and safe in patients with metastatic colon or rectum cancers.

Conditions

Metastatic Colorectal Cancer

Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing
Description

The objective of this study is to confirm the sensitivity and specificity of a stool DNA test for detection of colorectal cancer and pre-cancer.

Conditions

Colorectal Neoplasms, Digestive System Diseases, Colonic Diseases, Colorectal Cancer

Research Study of IV Vitamin C in Combination With Irinotecan vs Irinotecan Alone for Advanced Colorectal CA
Description

This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment with irinotecan versus treatment with irinotecan alone in patients with recurrent or advanced colorectal cancer who have failed at least one treatment regimen with a 5-FU based therapy. This study will be conducted as an amendment to Investigational New Drug # 77486.

Conditions

Stage IV Colorectal Cancer

Comparison Study of Hemorrhoid Surgery Using the Enseal Device to Standard Hemorrhoid Surgical Techniques
Description

The purpose of this study is to examine the advantages and disadvantages of using the EnSeal device in hemorrhoid surgery as compared to traditional hemorrhoid surgery techniques. It is hypothesized that the use of the Enseal device will demonstrate an improvement a patient's overall experience through less postoperative bleeding and pain, decreased time for wound healing, and a faster return to work.

Conditions

Hemorrhoids

Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer
Description

The primary objective is to determine the sensitivity and specificity of the Exact Colorectal Cancer (CRC) screening test for colorectal cancer, using colonoscopy as the reference method. Lesions will be confirmed as malignant by histopathologic examination. The secondary objective is to compare the performance of the Exact CRC screening test to a commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.

Conditions

Colorectal Neoplasms, Digestive System Diseases, Colonic Diseases, Colorectal Cancer

The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis
Description

The purpose of this study is to evaluate safety and tolerability of cyclically-dosed rectal budesonide foam in participants with active ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS).

Conditions

Proctitis, Proctosigmoiditis

Study of AUY922 and Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer
Description

The study will determine the maximum tolerated dose (MTD) of AUY922 given in combination with cetuximab in previously treated patients with KRAS wild-type metastatic colorectal cancer.

Conditions

Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer, Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum

Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies
Description

The objective of this study is to confirm the sensitivity of a stool DNA test for detection of colorectal cancer and pre-cancer. Another objective is to provide anonymous, clinically characterized specimens for a bio-repository for future colorectal cancer-related test development.

Conditions

Colorectal Neoplasms, Digestive System Diseases, Colonic Diseases, Colorectal Cancer

Intra-arterial Y-90 TheraSpheres for Hepatic Metastases From Solid Tumors
Description

This study is an open label prospective trial of TheraSphere treatment for patients who have liver metastases who have failed or are intolerant to other systemic or liver directed therapies. Patients will be treated with TheraSphere at doses of 120 ± 10% Gy, and then followed for time to progression (TTP), safety, and overall survival.

Conditions

Liver Neoplasms

Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
Description

The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who present with a diagnosis of active, mild to moderate, ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible participants will be allowed to maintain previously established oral 5-aminosalicylic acid (5-ASA) treatment at doses up to 4.8 grams/day (g/day).

Conditions

Proctitis, Proctosigmoiditis

Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
Description

The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who present with a diagnosis of active, mild to moderate, ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible participants will be allowed to maintain previously established oral 5-aminosalicylic acid (5-ASA) treatment at doses up to 4.8 grams/day (g/day).

Conditions

Proctitis, Proctosigmoiditis

Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
Description

The primary objective of the Phase II portion of this study is to assess the efficacy of KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)/CapOx (capecitabine and oxaliplatin) treatment failure in patients with metastatic colorectal cancer.

Conditions

Colorectal Cancer

Ultrasound and Photoacoustic Imaging for Enhanced Differential Diagnosis of Rectal Cancer
Description

The purpose of this study is to demonstrate the functionality of a novel endorectal photoacoustic ultrasound imaging modality in humans with rectal cancer. The study involves testing a previously developed endorectal device to determine its ability to accurately assess rectal tumor response to preoperative treatment. Investigators hypothesize that a co-registered photoacoustic ultrasound endorectal device can significantly reduce unnecessary surgeries in rectal cancer patients with complete clinical response while maintaining high sensitivity in identifying those with residual cancer.

Conditions

Rectal Cancer, Colorectal Cancer

EUS Evaluation of Perianal and Peri-rectal Fistulizing Crohn's Disease With CERTOLIZUMAB Treatment
Description

The primary objective of this study is to assess perianal and perirectal fistula healing (complete closure) based on endoscopic ultrasound (EUS) evaluation at 3 months and by PDAI (Pouchitis Disease Activity Index) and Fistula Drainage assessment by 6 months, showing no fistula (new or recurrence) in treatment of Crohn's' disease patient with Certolizumab (Cimzia).

Conditions

Crohns Disease

Nucleic Acid Amplification Tests (NAATs) for the Diagnosis of Pharyngeal and Rectal Chlamydia and Gonorrhea Infections
Description

Investigators at the University of Alabama in Birmingham in collaboration with investigators from the Centers for Disease Control in Atlanta are evaluating the performance of three commercial nucleic acid amplification tests for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in pharyngeal and rectal swab specimens. Cultures for C. trachomatis and N. gonorrhoeae are performed as additional reference tests. Study subjects are men and women attending sexually transmitted disease (STD) and HIV care clinics in Birmingham, Alabama, who report sexual behaviors that place them at risk for pharyngeal or rectal sexually transmitted infections.

Conditions

Chlamydia Infections, Gonorrhea

Hybrid Intelligence for Trustable Diagnosis and Patient Management of Prostate Cancer (HIT-PIRADS)
Description

The purpose of this study is to develop a new way to diagnose prostate cancer through the use of artificial intelligence. The goal is for this new method to reduce delays in diagnoses and to avoid invasive procedures such as biopsies.

Conditions

Prostate Cancer