Infections

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

All Conditions

Symptoms and General Pathology

Neoplasms

Digestive System Diseases

Mouth and Tooth Diseases

Rare Diseases

Rhinosinusitis

Nasal Polyps

Sinusitis

Colorectal Neoplasms

Nasopharyngeal Neoplasms

Rhinitis

Communicable Diseases

Respiratory Tract Infections

Paranasal Sinus Diseases

Nose Diseases

Respiratory Tract Diseases

Otorhinolaryngologic Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Chronic Graft Versus Host Disease

Pharmaceutical Solutions

All Drugs and Chemicals

Anti-Inflammatory Agents

Respiratory System Agents

Budesonide

Bronchodilator Agents

Anti-Asthmatic Agents

Glucocorticoids

Hormones

Hormone Antagonists

Buparid 1 mg budesonide/2 ml nebuliser solution

Budes® Nasal Spray 50 µg budesonide/pump

Sven Becker, MD

The study should create data for the selection of a clinically relevant primary endpoint to assess the efficacy and safety of Buparid/PARI SINUS as compared to Budes Nasal Spray in the therapy of chronic rhinosinusitis (CRS) with polyposis nasi in adult patients. Ideally, the selected parameter should allow a correlation between an objective methodology and the clinical outcome of the study patients.

Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis With Polyposis Nasi

A Pilot Study to Investigate the Efficacy and Safety of Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis (CRS) With Polyposis Nasi in Adult Patients

Health-specific quality of life was assessed by means of the self-rated, 22-item Sino-Nasal Outcome Test (SNOT-22). The SNOT-22 total score has a (theoretical) range of 0 - 110 points, with higher scores indicating more severe impairment.

Presented are the mean values of the SNOT-22 total score after 24 weeks minus value at day 0 (baseline).

Nasal obstruction was assessed using the method of rhinomanometry by measuring the positive nasal inspiratory flow (PNIF). For the assessment the subject had to inhale maximally through the nose three times and the highest value of flow rate was recorded after 4 weeks and 8 weeks of treatment.

Inflammation of the nasal mucosa and paranasal sinus was assessed using the Lund-Mackay score based on magnetic resonance imaging. The score can take on values between 0 and 24 points, with higher values indicating more severe impairment. The outcome investigated is the intraindividual mean score of 2 independent raters assessing the same images.

Treatment-emergent adverse events (AEs) Each participant has been monitored for adverse events up to 26 weeks. All patients withdrawn from the study will be followed-up for AEs or SAEs for further 2 weeks or 4 weeks, respectively.

Pari Pharma GmbH

Buparid 1 mg budesonide/2 ml nebuliser solution

Budesonide: Inhalation

Buparid; Treatment A

Budes® Nasal Spray 50 µg budesonide/pump

Budesonide: Nasal spray

Budes; Treatment B

Total

Age, Categorical

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Germany

Region of Enrollment

Friedrich gruber

Change of Inflammation of the Nasal Mucosa and Paranasal Sinus

Safety Assessment

Health-specific Quality of Life

Mean flow rate after 4 weeks

Mean flow rate after 8 weeks

Nasal Obstruction

Overall Study

Diseases and Abnormalities at or Before Birth

Syndrome

Hamartoma Syndrome, Multiple

Hamartoma

Neoplasms, Multiple Primary

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Cowden Syndrome

Bannayan-Riley-Ruvalcaba Syndrome

PTEN Hamartoma Tumor Syndrome

Anti-Infective Agents

Antineoplastic Agents

Herbal and Botanical

Sirolimus

Temsirolimus

MTOR Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Clotrimazole

Miconazole

Antifungal Agents

Immunosuppressive Agents

Immunologic Factors

Cola

There will be a clinic visit and colonoscopy at study entrance with standard of care sampling and assessment of polyps, including resection of concerning polyps. The investigators will also collect data on well-being via the SF-36 health survey (a validated questionnaire to help monitor this aspect given anecdotal patient-level reports of improvement while on therapy).

Study subjects will then begin sirolimus 2 mg by mouth daily for 1 year.

Laboratories will be checked at 4 days after initiation, at 2 weeks after initiation, then every 4 weeks for 3 months, then every 3 months to complete the year of therapy

Participants will have a clinic visit at 3, 6 and 9 months and include well-being assessment with the SF-36 health survey.

Participants will have a clinic visit with well-being assessment and perform colonoscopy at study closure at 12 months. The investigators will perform standard of care sampling and assessment of polyps, including resection of concerning polyps.

Use of sirolimus 2 mg by mouth daily for 1 year

Peter P Stanich, MD

Colon polyposis (the presence of multiple colon polyps) is very common with Cowden syndrome, as over 60% of patients have 50 or more polyps. In a previous clinical trial, some participants had reduction in the number of colon polyps with the use of the medication sirolimus for a very short time period. This study is investigating sirolimus and its effect on the number of colon polyps in patients with Cowden syndrome and polyposis over a 1 year period.

PTEN is a tumor suppressor gene that regulates the cell cycle through the phosphoinositide 3-kinase (PI3K)/Akt/mTOR pathway. When germline mutations in PTEN occur, the result is Cowden syndrome (or less commonly one of several related disorders collectively called the PTEN hamartoma tumor syndrome). This is characterized by the growth of hamartomas and a high risk of cancer in multiple organ systems. This includes colon polyps in 92.5% of Cowden syndrome patients and 64% with an estimated 50 or more polyps. Although outcomes of this are under reported, series suggest 20-38% of patients will receive colectomy.

Current clinical practice for Cowden syndrome is based on close surveillance for the development of cancers. Sirolimus (also known as rapamycin) is a specific inhibitor of mTOR that is FDA-approved for immunosuppression and use in several types of cancers as chemotherapy. It has also been used successfully in other hamartomatous syndromes including lymphangioleiomyomatosis. There is also a completed pilot clinical trial for adults with Cowden syndrome in which some had reduction in the number of colon polyps with the use of the medication sirolimus for a very short time period.

This will be an open-label pilot trial to determine whether sirolimus reduces colon polyp burden in Cowden syndrome. Sirolimus will be administered for one year. Colonoscopy with polyp estimation will be performed at trial entrance and at study completion.

Sirolimus for Cowden Syndrome With Colon Polyposis

Assessment of change in number of colon polyps. This will be assessed for each segment of colon (ascending, transverse, descending, sigmoid, rectum) and then aggregated into a total number of colon polyps. The entrance result will be compared to the final result for each participant.

Assessment of change in staging of colon polyps by using the International Society for Gastrointestinal Hereditary Tumors (InSIGHT) polyposis staging system. The InSight staging system divides colorectal polyposis into 5 progressive stages based on polyp number and size (Stage 0: \<20 polyps, all \<5 mm; Stage 1: 20-200 polyps, most \<5 mm, none, \>1 cm; Stage 2: 200-500 polyps, \<10 that are \>1 cm; Stage 3: 500-1000 polyps or any number if there are 10-50 that are \>1 cm and amenable to complete polypectomy; Stage 4: \>1000 polyps and/or any polyps grown to confluence and not amenable to simple polypectomy; any high-grade dysplasia or invasive cancer). The entrance result will be compared to the final result for each participant.

Assessment in change in overall health and quality of life as quantified by the SF-36 (Short Form) Health Survey. The SF-36 is a widely-used and standardized survey of participant responses to 36 questions that measures health-related quality of life. Each question has answers that are given a correlating score from 0 to 100, with a high score representing a more favorable health state. Through the combination of specific questions and averaging the scores, there are 8 scales (physical functioning, role limitations due to physical health, role limitations due to emotional problems, vitality, mental health, social functioning, bodily pain, and general health) that are reported with scores from 0 to 100, with a high score representing a more favorable health state. These can also be averaged into a physical component summary score and mental component summary score that is again from 0 to 100, with a high score representing a more favorable health state.

PTEN Research

Pfizer

Ohio State University

Associate Professor, Division of Gastroenterology, Hepatology & Nutrition

Chronic Disease

Disease Attributes

each subject serves as their own control with one nostril being treated with pulmicort and one not

pulmicort

Garrett R Griffin, MD

That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery.

Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis

will be measured with the University of Pennsylvania Smell Identification Test (UPSIT), whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification

will be assessed with the Perioperative Sinus Endoscopy score (POSE), a 20 point scale where 0 is no sinus challenges and 20 represents the greatest blockage.

Scored with the University of Pennsylvania Smell Identification Test, whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification

Assessed with Perioperative Sinus Endoscopy (POSE) score

American Rhinologic Society

University of Michigan

Resident/Research Fellow

each subject serves as their own control with one nostril being treated with pulmicort and one not

pulmicort: applied to nasal packing after surgery

Single Arm; Nostrils as Experimental and Comparator

Race (NIH/OMB)

United States

This was a pilot study with less enrollment than desired and poor rate of completion with only 5 participants completing the full 24 week trial. This study could be done on a larger/similar scale with some additional useful data obtained.

Garrett Griffin, MD

Treated Nostril (Pulmicort)

Untreated Nostril (no Pulmicort)

Of sixteen participants at the three week mark, one participant's data was unable to be unblinded accurately, and one participant had no UPSIT scores taken, leaving an analysis population of 14,

Olfaction

Placebo Treated Nostril (no Pulmicort)

unblinding could not be done on one person accurately, so only 15 rather than 16 people's data could be analyzed

Sinonasal Health

Placebo/Untreated Nostril (no Pulmicort)

Of six participants remaining at 24 weeks, one participant's data could not be accurately unblinded leaving analysis of 5

Of six participants at 24 weeks, one's data was unable to be unblinded accurately, leaving an analysis population of 5 participants

Crohn Disease

Colitis

Colitis, Ulcerative

Ulcer

Prolapse

Diverticulitis

Rectal Prolapse

Inflammatory Bowel Diseases

Gastroenteritis

Pathological Conditions, Anatomical

Diverticulum

Diverticular Diseases

Pelvic Organ Prolapse

Constitution of a prospective, multicenter clinical database of surgery with robotic assistance in colorectal pathologies

Clinical database

Philippe Rouanet, MD

Evaluation of robot Da Vinci Xi by determining its learning curve.The operating time will be defined by patient then the operating average will be calculated.

Since the emergence of minimally invasive technology twenty years ago, as a surgical concept and surgical technique for colorectal cancer surgery, its obvious advantages have been recognized.

Laparoscopic technology, as one of the most important technology platform, has got a lot of evidence-based support for the oncological safety and effectiveness in colorectal cancer surgery Laparoscopic technique has advantages in terms of identification of anatomic plane and autonomic nerve, protection of pelvic structure, and fine dissection of vessels.

But because of the limitation of laparoscopic technology there are still some deficiencies and shortcomings, including lack of touch and lack of stereo vision problems, in addition to the low rectal cancer, especially male, obese, narrow pelvis, larger tumors, it is difficult to get better view and manipulating triangle in laparoscopy. However, the emergence of a series of new minimally invasive technology platform is to make up for the defects and deficiencies. The robotic surgical system possesses advantages, such as stereo vision, higher magnification, manipulator wrist with high freedom degree, filtering of tremor and higher stability, but still has disadvantages, such as lack of haptic feedback, longer operation time, high operation cost and expensive price.

3D system of laparoscopic surgery has similar visual experience and feelings as robotic surgery in the 3D view, the same operating skills as 2D laparoscopy and a short learning curve. Transanal total mesorectal excision (taTME) by changing the traditional laparoscopic pelvic surgery approach, may have certain advantages for male cases with narrow pelvic and patients with large tumor.

No prospective study has compared these four surgical techniques. Furthermore, the learning curve still remains a crucial problem in term of data interpretation.

We will collect synchronized videos and data on surgeon performance during colorectal surgeries using the Vinci Logger (dVLogger, Intuitive Surgical, Inc.), it is a personalized recording tool that captures synchronized video in the form of endoscope view at 30 frames per second. Kinematic data included characteristics of movement such as instrument travel time, path length and velocity. Events included frequency of master controller clutch use, camera movements, third arm swap and energy use.

We will explore and validate objective surgeon performance metrics using novel recorder ("dVLogger") to directly capture surgeon manipulations on the daVinci Surgical System.

Clinical Database of Colorectal Robotic Surgery

French Prospective Clinical Database of Colorectal Robotic Surgery

This questionnaire assessed the bowel function of patient. The range is from 8 (low function) to 35 (high function)

The range is from 1 (low erectile function) to 27 (high erectile function)

The range is from 3 (low sexual function) to 55 (high sexual function).

The range is from 0 (low urinary function) to 40 (high urinary function).

The quality of the mesorectum resection is determined by the pathologist according to the aspect of mesorectum, the circumferential resection margin, cone effect .

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis With Polyposis Nasi	NCT01946711	Rhinosinusitis Chronic Polypos...	Budesonide Budesonide	18 Years -	Pari Pharma GmbH
Sirolimus for Cowden Syndrome With Colon Polyposis	NCT04094675	PTEN Gene Mutat... PTEN Hamartoma ... PTEN Hamartoma ... Cowden Syndrome Bannayan Syndro... Bannayan Zonana... Polyposis	Sirolimus	18 Years - 80 Years	Ohio State University
Sirolimus for Cowden Syndrome With Colon Polyposis	NCT04094675	PTEN Gene Mutat... PTEN Hamartoma ... PTEN Hamartoma ... Cowden Syndrome Bannayan Syndro... Bannayan Zonana... Polyposis	Sirolimus	18 Years - 80 Years	Ohio State University
Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis	NCT01197612	Chronic Sinusit... Polyposis	pulmicort	18 Years - 99 Years	University of Michigan
Clinical Database of Colorectal Robotic Surgery	NCT04013152	Crohn Disease Polyposis Ulcerative Coli... Diverticulitis Colorectal Tumo... Rectal Prolapse Benign Colorect...	Clinical databa...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle

Spots Global Cancer Trial Database for polyposis

Every month we try and update this database with for polyposis 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 polyposis

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