Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

MR-Guided Laser Thermal ablation of brain lesions using the TRANBERG® Thermal Therapy System and TRANBERG ® Thermoguide Workstation.

The main purpose with the study is to investigate safety and feasibility of the TRANBERG® laser applicators when used in MR-guided laser thermal ablation of brain lesions using the TRANBERG® Thermal Therapy System and TRANBERG® Thermoguide Workstation together with SmartTwist™ MR Hand Drill with the SmartTip™ MR Drill Kit for MR-guided laser thermal ablation of brain lesions.

TRANBERG® laser applicators when used in MR-guided laser thermal ablation of brain lesions using the TRANBERG® Thermal Therapy System and TRANBERG® Thermoguide Workstation.

Karin Peterson

Peter Siesjö, Prof

This will be an open-label, pilot, exploratory, single centre clinical investigation. This is an early feasibility single arm study. No formal hypothesis is proposed. A total of up to 15 evaluable subjects receiving a non-radical ablation is planned.

The safety and feasibility outcomes will be measured directly post-treatment, 48h and 3 months post-treatment.

A minimal invasive neurosurgical approach with a Magnetic Resonance Imaging (MRI)-based stereotactic guidance system will be utilized for the planning, navigation, intracranial access, placement and confirmation of the Laser applicator prior to ablation.

Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions

Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesion Using the Tranberg® Thermal Therapy System and Tranberg® Thermoguide Workstation

The volume of remaining tumor mass will be assessed by contrast enhanced MRI after MR-Guided laser thermal ablation using the TRANBERG® Thermal Therapy System and TRANBERG® Thermoguide Workstation.

The number and severity of adverse events related to the TRANBERG® Laser applicator when used in MR-guided laser thermal ablation of brain lesions

The number and severity of adverse events related to the SmartTwist™ MR HAND DRILL with the SmartTip™ MR Drill Kit when used for intracranial access.

Clinical Laserthermia Systems AB

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Recurrence

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Disease Attributes

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

All Drugs and Chemicals

BCG Vaccine

Vaccines

Adjuvants, Immunologic

Immunologic Factors

* Bacillus Calmette-Guérin (BCG): Strain Russian BCG-I
* Freeze-dried powder for bladder instillation

* Standard of Care
* Bacillus Calmette-Guérin (BCG): Strain TICE
* Freeze-dried powder for bladder instillation

* Induction: 80 mg weekly for 6 weeks.
* Maintenance for intermediate AUA risk patients will be for 3 weeks at 3, 6, and 12 months.
* Maintenance for high AUA risk patients will be for 3 weeks at 3, 6, 12, 18, 24, 30 and 36 months.

Bacillus Calmette-Guerin: Strain Russian BCG-I

* Induction: 50 mg weekly for 6 weeks.
* Maintenance for intermediate AUA risk patients will be for 3 weeks at 3, 6, and 12 months.
* Maintenance for high AUA risk patients will be for 3 weeks at 3, 6, 12, 18, 24, 30 and 36 months.

Bacillus Calmette-Guerin: Strain TICE

Jalees Farhan

Taniya Mann

Alexandre R Zlotta, MD

Girish S Kulkarni, MD

The aim of this study is to evaluate the effect of Verity-BCG in patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) and to compare our findings to the standard of care BCG formulation, OncoTICE (BCG) in order to examine our hypothesis that Verity-BCG is at least non-inferior to OncoTICE in achieving 24-month Recurrence Free Survival in NMIBC patients who are at high risk of recurrence and have never been treated with intradermal or intravesical BCG before, with the exception of tuberculosis vaccination in childhood.

This study is a randomized, active control, double-blind clinical trial aimed at demonstrating non - inferiority of VERITY-BCG to OncoTICE, the current standard of care, with respect to two-year Recurrence Free Survival (RFS) rates in NMIBC BCG - naïve patients that are at high risk for recurrence (defined as \>50%).

• Recurrence will be defined as the reappearance of any of the NMIBC tumors as confirmed by cystoscopic biopsy or TURBT.

Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)

A Multicenter, Randomized, Double-blind, Controlled Phase III Non-inferiority Study Assessing Efficacy and Safety of VERITY-BCG in Management of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC) in BCG-naïve Patients.

Incidence of treatment-emergent AEs and SAEs defined according to the CTCAE v5.0;

Number of subjects discontinuing study drug due to AEs

Usage of concomitant medications over time.

Cumulative Recurrence Free Survival (RFS) at 24 months following 1st intravesical instillation as estimated using the Kaplan - Meier estimator of the survival function.

Recurrence will be defined as the reappearance of any of the NMIBC tumors as confirmed by cystoscopic biopsy or TURBT.

Cumulative Recurrence Free Survival (RFS) at 36 months following 1st intravesical instillation as estimated using the Kaplan - Meier estimator of the survival function.

Progression Free Survival (PFS) at 24 months as estimated using the Kaplan - Meier estimator of the survival function.

Progression Free Survival (PFS) at 36 months as estimated using the Kaplan - Meier estimator of the survival function.

Overall Survival (OS) at 36 months as estimated using the Kaplan - Meier estimator of the survival function.

Change in Quality of Life as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire for NMIBC (EORTC-QLQ-NMIBC24) over 36 months.

The EORTC QLQ-NMIBC24 is a 24-item self-administered questionnaire that measures health-related quality of life in patients with intermediate to high-risk NMIBC. Items are ranked by the patient from 1 to 4 indicating the extent to which they have experienced those symptoms or problems. 1 = Not at All, 2 = A little, 3=Quite a bit, 4 = Very Much.

- High Score is equivalent to more problems, except for items on sexual function and sexual enjoyment for which a high score is interpreted as better function.

Change in functioning and symptom status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire for Cancer Patients (EORTC-QLQ-C30) over 36 months.

The EORTC QLQ-C30 consists of 30 items and measures Health Related Quality of Life as well as presence of symptoms across all cancer types. The QLQ-C30 includes nine multi-item scales:

* 5 functional scales (physical, role, cognitive, emotional, and social)
* 3 symptom scales (fatigue, pain, and nausea and vomiting);
* A global health and quality-of-life scale\*
* Several single-item symptom measures

  28 Items are ranked 1 to 4. 1 = Not at All, 2 = A little, 3=Quite a bit, 4 = Very Much.

  \*2 items are ranked 1 to 7. 1=Very Poor, 7 = Excellent.

High score = More symptoms or worse problems

\*High Score = Better overall health or Quality of life.

Verity Pharmaceuticals Inc.

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

Gemcitabine

Tremelimumab

Antimetabolites

Escalating doses of CP-675,206 will be administered by IV infusion on day 1 of each 84-day treatment cycles (doses of 6, 10 and 15 mg/kg are planned). Gemcitabine will be administered by IV infusion, at a fixed dose of 1000 mg/m2 on days 1 (prior to CP-675,206) and again on days 8, 15, 29, 36, 43, 57, 64, and 71. Repeated cycles of gemcitabine and CP-675,206 will be administered until patients develop progressive disease or unacceptable toxicity, or for a maximum of 4 cycles, whichever occurs first.

CP-675,206 and gemcitabine

The purpose of this study is to determine the safety and tolerability of different doses of CP-675,206 in combination with gemcitabine and to determine the maximum dose of CP-675,206 that is well tolerated when given in combination with gemcitabine to patients with advanced pancreatic cancer.

A Phase 1 Study Testing CP-675,206 In Combination With Gemcitabine In Patients With Previously Untreated, Advanced Pancreatic Cancer

A Phase 1 Dose Escalation Trial Of CP-675,206 In Combination With Gemcitabine In Patients With Chemotherapy Naive Metastatic Pancreatic Cancer

AstraZeneca

Blood and Lymph Conditions

Mouth and Tooth Diseases

Leukemia

Mucositis

Oral Manifestations

Gastroenteritis

Mouth Diseases

Stomatognathic Diseases

Group 1 will include patients with oral mucositis grade 1. Sera used wavelength of 660nm, power 100mW and lluencia of 4 J / cm².

Group 2 included patients with oral mucositis grade 2. Sera used with a wavelength of 660nm, power 100mW and lluencia of 8 J / cm².

Group 3 included patients with oral mucositis grade 3 Sera used laser diode AsGaAl operating in continuous mode, with a wavelength of 790 nm, power of 100mW and fluency of 8 J / cm².

Patients who develop oral mucositis even after the prevention, will be divided into three groups for laser sessions with the purpose of treatment of oral mucositis. The group assignment obeyed severity of oral mucositis.

Laser

Bruno CV Gurgel

Salomão IML Queiroz

Bruno CV Gurgel, Doctor

Before the start of the selected chemotherapy patients will be treated preventively for oral mucositis. A group will carry out the mouthwash with chlorhexidine 0.12% twice a day for five days and another will be held to damage preventive therapy (wavelength of 660nm, power 100mW and lluencia of 4 J / cm² per point, with distance of 2cm between points located on the right buccal mucosa, left buccal mucosa, hard palate, upper lip and lower lip). Patients who develop oral mucositis even after the prevention, will be divided into three groups for laser sessions with the purpose of treatment of oral mucositis. The group assignment obeyed severity of oral mucositis. Group 1 will include patients with oral mucositis grade 1. Sera used wavelength of 660nm, power 100mW and lluencia of 4 J / cm². Group 2 included patients with oral mucositis grade 2. Sera used with a wavelength of 660nm, power 100mW and lluencia of 8 J / cm². Group 3 included patients with oral mucositis grade 3 Sera used laser diode AsGaAl operating in continuous mode, with a wavelength of 790 nm, power of 100mW and fluency of 8 J / cm².

Before the start of the selected chemotherapy patients will be treated preventively for oral mucositis. A group will carry out the mouthwash with chlorhexidine 0.12% twice a day for five days and another will be held to damage preventive therapy (wavelength of 660nm, power 100mW and lluencia of 4 J / cm² per point, with distance of 2cm between points located on the right buccal mucosa, left buccal mucosa, hard palate, upper lip and lower lip). Patients who develop oral mucositis even after the prevention, will be divided into three groups for laser sessions with the purpose of treatment of oral mucositis. The group assignment obeyed severity of oral mucositis. Group 1 will include patients with oral mucositis grade 1. Sera used wavelength of 660nm, power 100mW and lluencia of 4 J / cm². Group 2 included patients with oral mucositis grade 2. Sera used with a wavelength of 660nm, power 100mW and lluencia of 8 J / cm². Group 3 included patients with oral mucositis grade 3 Sera used laser diode AsGaAl operating in continuous mode, with a wavelength of 790 nm, power of 100mW and fluency of 8 J / cm².

The assessment of oral mucositis will be held with the WHO classification: grade 0 = no mucositis; Grade I = erythema without injury; Grade II = ulcers, but can eat; Grade III = painful sores, but able to consume liquid food (nutrition), with support of analgesia; Grade IV = requires parenteral or enteral support and continuous analgesia.

The patient also conduct a self-assessment of pain by visual analog scale pain quantifying 0-10 before the laser section and after the first application.

Pediatric male or female, diagnosed with cancer who have not yet started cancer treatment, with otherwise healthy oral mucosa in the initial dental exam.

Patients who have already started treatment for cancer under radiotherapy or presenting traumatic factors (such as braces or restorations with sharp edges), or presenting ulcers in the mucosa at the initial examination.

Oral Manifestations in Children With Cancer

Oral Manifestations of Leukemia and Anticancer Treatment in Childhood

The assessment of oral mucositis will be held with the WHO classification: grade 0 = no mucositis; Grade I = erythema without injury; Grade II = ulcers, but can eat; Grade III = painful sores, but able to consume liquid food (nutrition), with support of analgesia; Grade IV = requires parenteral or enteral support and continuous analgesia.

The patient also conduct a self-assessment of pain by visual analog scale pain quantifying 0-10 before the laser section and after the first application.

Universidade Federal do Rio Grande do Norte

PhD student

Skin and Connective Tissue Diseases

Melanoma

Disease Progression

Melanoma, Cutaneous Malignant

Skin Neoplasms

Neuroendocrine Tumors

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neuroendocrine Tumor

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

Propranolol

Adrenergic beta-Antagonists

Adrenergic Agents

Adrenergic Antagonists

Neurotransmitter Agents

113 patients will be enrolled in the placebo group with respect to randomization.

Placebo group will be prescribed placebo pills in the same packaging as propranolol treated group.

The frequency and duration of the treatment is the same as propranolol arm. The placebo group will have the same cardiology consultation as propranolol treated group to ensure the respect of blindness.

drug: 'Propranolol hydrochloride' 338 patients will be enrolled in the "Propranolol" Group and treated with propranolol.

The dosage will be determined by the cardiologist as the maximum tolerated dose to a maximum of 160mg/day.

One long acting pill a day until an evidence of disease progression or the end of the study.

This intervention apply to Propranolol group

Propranolol hydrochloride

We use placebo pills alike propranolol commercial pills to ensure blindness of the subjects during the study.

Placebo pill

Frédérique-Anne Le Gal, MD/PhD

Melanoma's incidence is increasing worldwide. The efforts made in melanoma screening led to an earlier detection of the primary tumour and a better prognosis, but melanoma remains an aggressive cancer when it comes to its metastatic stage. Three recent retrospective studies compared groups of patients diagnosed with primary melanoma and treated with betablockers for another indication to patients who never received betablockers. In these three studies, the outcome of the disease is significantly better for people under betablocker treatment with a decreased rate of recurrence and a better 5 years survival rate. Here we want to investigate the efficacy and the tolerability of an adjuvant treatment with propranolol for patients suffering from a primary melanoma with a high risk of recurrence.

Efficacy of Propranolol Treatment to Prevent Melanoma Progression

Phase 2 Prospective Study of the Efficacy of Propranolol on Malignant Melanoma Progression. A Randomized Placebo-controlled,Single Blind Trial

The efficacy of propranolol treatment will be tested in one interim analysis when the last patient enrolled have reached one year of follow up and one final analysis when the last patient enrolled have reached three years of follow up. The primary endpoint of the study will be the progression of the disease.

We will measure the efficacy of a propranolol treatment on the risk of progression of the disease.

We will investigate the microRNA profile in the serum of patients of both groups during the whole study to identify biomarkers specific for recurrence.

We investigate the impact of propranolol treatment on the 5 years survival.

University Hospital, Geneva

Associate Physician, PD, MD/PhD

Adenoma

Herbal and Botanical

Cola

During the examination, the endoscopic physician required to stay in place while rinsing, and the lens could only be withdrawn after rinsing.

During the examination, the recorder should record the time points of the right colon, transverse colon, and left colon, as well as the time of irrigation.

If both are considered to be properly, then second colonoscopy was performed immediately.

If both results agree or either side agrees that the gut is not well prepared, the review will be carried out within a year

Bowel readiness

Honggang Yu, PhD

Boru Chen, master

To verify the correlation between the proposed artificial intelligence based bowel preparation assessment system and the missed detection rate of adenomas, and to evaluate whether the system can effectively assist doctors in identifying patients who need to be re-examined by colonoscopy due to poor intestinal cleanliness.

Quantitative Bowel Readiness Assessment System in Predicting the Missed Detection Rate of Adenomas

A Single-center Study of an AI-assisted Quantitative Bowel Readiness Assessment System in Predicting the Missed Detection Rate of Adenomas Under Colonoscopy

(≥ 5mm adenoma missed rate, ≥ 5mm AMR) : Each patient will receive two colonoscopy examinations. The ≥ 5mm adenoma that were not detected in the first colonoscopy was define as missed ≥ 5mm adenoma. Numerator is the number of missed detection of ≥5mm adenomas during colonoscopy, and denominator is the total number of ≥ 5mm adenomas receiving colonoscopy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions	NCT05296122	Glioblastoma	TRANBERG® laser...	18 Years - 80 Years	Clinical Laserthermia Systems AB
Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions	NCT05296122	Glioblastoma	TRANBERG® laser...	18 Years - 80 Years	Clinical Laserthermia Systems AB
Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)	NCT05037279	Bladder Cancer Bladder Cancer ... Neoplasm Recurr... Urothelial Carc... Urothelial Carc... Non-Invasive Bl...	Bacillus Calmet... Bacillus Calmet...	18 Years -	Verity Pharmaceuticals Inc.
A Phase 1 Study Testing CP-675,206 In Combination With Gemcitabine In Patients With Previously Untreated, Advanced Pancreatic Cancer	NCT00556023	Pancreatic Canc...	CP-675,206 and ...	18 Years -	AstraZeneca
Oral Manifestations in Children With Cancer	NCT02662465	Mucositis	Laser	1 Year - 25 Years	Universidade Federal do Rio Grande do Norte
Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)	NCT05037279	Bladder Cancer Bladder Cancer ... Neoplasm Recurr... Urothelial Carc... Urothelial Carc... Non-Invasive Bl...	Bacillus Calmet... Bacillus Calmet...	18 Years -	Verity Pharmaceuticals Inc.
Efficacy of Propranolol Treatment to Prevent Melanoma Progression	NCT01988831	Stages III Skin... Stages II Skin ... Stage IB Skin M...	Propranolol hyd... Placebo pill	18 Years -	University Hospital, Geneva
A Phase 1 Study Testing CP-675,206 In Combination With Gemcitabine In Patients With Previously Untreated, Advanced Pancreatic Cancer	NCT00556023	Pancreatic Canc...	CP-675,206 and ...	18 Years -	AstraZeneca
Quantitative Bowel Readiness Assessment System in Predicting the Missed Detection Rate of Adenomas	NCT05145712	Self Control Prospective Interventional	Bowel readiness	45 Years -	Renmin Hospital of Wuhan University

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