‘Rollover’ abdominal paracentesis versus standard technique: protocol of a crossover randomized comparative trial

The sensitivity of single abdominal paracentesis for diagnosis of peritoneal carcinomatosis in patients with malignant ascites is 40–70%. Tumor cells shed from the peritoneum settle preferentially in certain recesses of the peritoneum. We aim to compare the standard technique of abdominal paracentesis versus a rollover technique in a randomized crossover study to assess the cytological yield in patients suspected to have peritoneal carcinomatosis. Each patient will serve as their own control and the outcome assessor (cytopathologist) will be blinded to the method of paracentesis performed. The primary objective will be to compare the tumor cell positivity between the standard paracentesis group and the rollover group among enrolled patients. Clinical Trial registration: CTRI/2020/06/025887 and NCT04232384 .

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Protocol forDigital Real-world Evidence trial for Adults with insomnia treated via Mobile (DREAM): an open-label trial of a prescription digital therapeutic for treating patients with chronic insomnia

Journal of Comparative Effectiveness Research ◽

10.2217/cer-2021-0004 ◽

2021 ◽

Author(s):

Frances P Thorndike ◽

Richard B Berry ◽

Robert Gerwien ◽

Stephen Braun ◽

Yuri A Maricich

Keyword(s):

Clinical Trial ◽

Real World ◽

Behavioral Therapy ◽

Primary Objective ◽

Chronic Insomnia ◽

World Population ◽

Open Label ◽

Clinical Trial Registration ◽

Real World Evidence ◽

Evidence Trial

Background: Cognitive behavioral therapy for insomnia (CBT-I) is underused in healthcare settings and is challenging for people with insomnia to access because of uneven geographical distribution of behavioral sleep medicine providers. Prescription digital therapeutics can overcome these barriers. This study evaluates the effectiveness of a specific digital CBT-I therapeutic. Materials & methods: Digital Real-world Evidence trial for Adults with insomnia treated via Mobile (DREAM) is a 9-week, open-label, decentralized clinical trial to collect real-world evidence for a digital therapeutic (Somryst™) delivering CBT-I to patients with chronic insomnia. The primary objective is to examine the effectiveness of Somryst to reduce self-reported insomnia symptoms and severity in a real-world population (n = 350). Conclusion: This pragmatic study seeks to assess the potential benefits of treating insomnia with an asynchronous, mobile, tailored prescription digital therapeutic. Clinical trial registration: NCT04325464 (ClinicalTrials.gov)

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Phase I Clinical Trial of a Genetically Modified and Oncolytic Vaccinia Virus GL-ONC1 in patients with peritoneal carcinomatosis

Zeitschrift für Gastroenterologie ◽

10.1055/s-0032-1324086 ◽

2012 ◽

Vol 50 (08) ◽

Author(s):

UM Lauer ◽

M Zimmermann ◽

U Koppenhöfer ◽

M Bitzer ◽

NP Malek ◽

...

Keyword(s):

Clinical Trial ◽

Phase I ◽

Vaccinia Virus ◽

Peritoneal Carcinomatosis ◽

Genetically Modified ◽

Phase I Clinical Trial

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A review of international clinical trial registration

Journal of Chinese Integrative Medicine ◽

10.3736/jcim20070302 ◽

2007 ◽

Vol 5 (3) ◽

pp. 234-242 ◽

Cited By ~ 4

Author(s):

He Yu

Keyword(s):

Clinical Trial ◽

Trial Registration ◽

Clinical Trial Registration ◽

International Clinical Trial

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A Phase Ib Clinical Trial of Metformin and Chloroquine in Patients with IDH1-Mutated Solid Tumors

Cancers ◽

10.3390/cancers13102474 ◽

2021 ◽

Vol 13 (10) ◽

pp. 2474

Author(s):

Mohammed Khurshed ◽

Remco J. Molenaar ◽

Myra E. van Linde ◽

Ron A. Mathôt ◽

Eduard A. Struys ◽

...

Keyword(s):

Clinical Trial ◽

Solid Tumors ◽

Intrahepatic Cholangiocarcinoma ◽

Maximum Tolerated Dose ◽

Primary Objective ◽

Idh1 Mutation ◽

Resonance Spectroscopy ◽

Isocitrate Dehydrogenase 1 ◽

Who Grade ◽

Phase Ib

Background: Mutations in isocitrate dehydrogenase 1 (IDH1) occur in 60% of chondrosarcoma, 80% of WHO grade II-IV glioma and 20% of intrahepatic cholangiocarcinoma. These solid IDH1-mutated tumors produce the oncometabolite D-2-hydroxyglutarate (D-2HG) and are more vulnerable to disruption of their metabolism. Methods: Patients with IDH1-mutated chondrosarcoma, glioma and intrahepatic cholangiocarcinoma received oral combinational treatment with the antidiabetic drug metformin and the antimalarial drug chloroquine. The primary objective was to determine the occurrence of dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD). Radiological and biochemical tumor responses to metformin and chloroquine were investigated using CT/MRI scans and magnetic resonance spectroscopy (MRS) measurements of D-2HG levels in serum. Results: Seventeen patients received study treatment for a median duration of 43 days (range: 7–74 days). Of twelve evaluable patients, 10 patients discontinued study medication because of progressive disease and two patients due to toxicity. None of the patients experienced a DLT. The MTD was determined to be 1500 mg of metformin two times a day and 200 mg of chloroquine once a day. A serum D/L-2HG ratio of ≥4.5 predicted the presence of an IDH1 mutation with a sensitivity of 90% and a specificity of 100%. By utilization of digital droplet PCR on plasma samples, we were able to detect tumor-specific IDH1 hotspot mutations in circulating tumor DNA (ctDNA) in investigated patients. Conclusion: Treatment of advanced IDH1-mutated solid tumors with metformin and chloroquine was well tolerated but did not induce a clinical response in this phase Ib clinical trial.

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Effect of noisy galvanic vestibular stimulation on dynamic posture sway under visual deprivation in patients with bilateral vestibular hypofunction

Scientific Reports ◽

10.1038/s41598-021-83206-z ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Po-Yin Chen ◽

Ying-Chun Jheng ◽

Chien-Chih Wang ◽

Shih-En Huang ◽

Ting-Hua Yang ◽

...

Keyword(s):

Clinical Trial ◽

Light Exposure ◽

Light Condition ◽

Vestibular Stimulation ◽

Galvanic Vestibular Stimulation ◽

Lateral Deviation ◽

Clinical Trial Registration ◽

Vestibular Hypofunction ◽

Dark Conditions ◽

Bilateral Vestibular Hypofunction

AbstractA single-blind study to investigate the effects of noisy galvanic vestibular stimulation (nGVS) in straight walking and 2 Hz head yaw walking for healthy and bilateral vestibular hypofunction (BVH) participants in light and dark conditions. The optimal stimulation intensity for each participant was determined by calculating standing stability on a force plate while randomly applying six graded nGVS intensities (0–1000 µA). The chest–pelvic (C/P) ratio and lateral deviation of the center of mass (COM) were measured by motion capture during straight and 2 Hz head yaw walking in light and dark conditions. Participants were blinded to nGVS served randomly and imperceivably. Ten BVH patients and 16 healthy participants completed all trials. In the light condition, the COM lateral deviation significantly decreased only in straight walking (p = 0.037) with nGVS for the BVH. In the dark condition, both healthy (p = 0.026) and BVH (p = 0.017) exhibited decreased lateral deviation during nGVS. The C/P ratio decreased significantly in BVH for 2 Hz head yaw walking with nGVS (p = 0.005) in light conditions. This study demonstrated that nGVS effectively reduced walking deviations, especially in visual deprived condition for the BVH. Applying nGVS with different head rotation frequencies and light exposure levels may accelerate the rehabilitation process for patients with BVH.Clinical Trial Registration This clinical trial was prospectively registered at www.clinicaltrials.gov with the Unique identifier: NCT03554941. Date of registration: (13/06/2018).

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MEBO versus topical Diltiazem versus a combination of both ointments in the treatment of acute anal fissure: a randomized clinical trial protocol

BMC Complementary Medicine and Therapies ◽

10.1186/s12906-021-03227-z ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Mohamad Hadi El Charif ◽

Samer Doughan ◽

Rawya Kredly ◽

Sara Kassas ◽

Rayan Azab ◽

...

Keyword(s):

Clinical Trial ◽

Wound Healing ◽

Anal Fissure ◽

Topical Therapy ◽

Trial Registration ◽

Clinical Trial Registration ◽

Anal Fissures ◽

Link Type ◽

Anorectal Region ◽

Registration Date

Abstract Background Anal fissure is a common complication of the anorectal region and one of the most reported causes of anal pain. Acute anal fissure can be cured by surgery or medical treatment. There is an increase in the use of topical therapy for the treatment of anal fissures. A common topical drug used is Diltiazem (DTZ), a calcium-channel blocker, which relaxes the anal sphincter and thus promotes healing of the anal fissure. Moist exposed burn ointment (MEBO) is an ointment that is effective for the treatment of burns and wound healing and is becoming popular in the treatment of anal fissures. Methods This is a 1:1:1 randomized, controlled, parallel design, with endpoint measures of change in pain score, wound healing, defecation strain score and patient’s global impression of improvement. The study will be conducted at AUBMC over a 10-week period. Patients will be randomized to three treatment arms: MEBO, Diltiazem, and a combination of MEBO and Diltiazem ointments. Discussion The results of this study will allow physicians to assess the efficacy and safety of MEBO in the treatment of acute anal fissure, and also in comparison to Diltiazem. This trial will generate evidence-based conclusions regarding the use of a herbal/natural-based product (MEBO ointment) for the treatment of anal fissures. Trial registration ClinicalTrials.gov Identifier NCT04153032. Clinical Trial Registration Date: 06-NOVEMBER-2019.

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Rationale and Design of BeatNF2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Bevacizumab in Patients with Neurofibromatosis Type 2 Related Vestibular Schwannoma

Current Oncology ◽

10.3390/curroncol28010071 ◽

2021 ◽

Vol 28 (1) ◽

pp. 726-739

Author(s):

Masazumi Fujii ◽

Masao Kobayakawa ◽

Kiyoshi Saito ◽

Akihiro Inano ◽

Akio Morita ◽

...

Keyword(s):

Clinical Trial ◽

Neurofibromatosis Type ◽

Primary Objective ◽

Neurofibromatosis Type 2 ◽

Efficacy And Safety ◽

Multicenter Clinical Trial ◽

Double Blind ◽

Hearing Function ◽

Initial Intervention

Neurofibromatosis type 2 (NF2) causes bilateral vestibular schwannomas (VSs), leading to deafness. VS is treated by surgery or radiation, but neither treatments prevent hearing loss. Bevacizumab was found to be effective in suppressing the tumor’s growth and may help to improve hearing. We are conducting a randomized, double-blind, multicenter clinical trial to verify the efficacy and safety of bevacizumab in NF2-related VS. The primary objective is to evaluate the efficacy of bevacizumab in improving hearing in the affected ear. One of the secondary objectives is to evaluate bevacizumab’s efficacy in rechallenge treatment in relapsed cases. Sixty patients will randomly receive either bevacizumab or a placebo and will be clinically observed for 48 weeks in the initial intervention phase. In the first half (24 weeks), they will receive either 5 mg/kg of bevacizumab or a placebo drug. In the second half, all patients will receive 5 mg/kg of bevacizumab. If hearing function deteriorated in a patient who had shown improvement during the first phase, a rechallenge dose with bevacizumab would be offered.

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Expression of inflammatory mediators in biofilm samples and clinical association in inflammatory bowel disease patients—a preliminary study

Clinical Oral Investigations ◽

10.1007/s00784-021-04093-2 ◽

2021 ◽

Author(s):

Mayte Buchbender ◽

Jakob Fehlhofer ◽

Peter Proff ◽

Tobias Möst ◽

Jutta Ries ◽

...

Keyword(s):

Clinical Trial ◽

Inflammatory Bowel Disease ◽

Oral Cavity ◽

Bowel Disease ◽

Trial Registry ◽

Clinical Trial Registry ◽

Clinical Trial Registration ◽

Expression Levels ◽

Inflammatory Bowel ◽

Group 2

Abstract Objectives Inflammatory bowel disease (IBD) has multiple impacts on soft and hard tissues in the oral cavity. The aim of this study was to analyze the expression of cytokines in biofilm samples from patients suffering from IBD and compare them to healthy patients. It was hypothesized that different cytokine expression levels and clinical associations might be drawn. Material and methods A total of 56 biofilm samples from three different patient cohorts (group 0 = healthy, HC n = 30; group 1 = Crohn’s disease, CD, n = 19; group 2 = ulcerative colitis, UC, n = 7) were examined for the expression levels of the cytokine interleukins IL-2, -6, and -10; matrix metalloproteinases 7 and 9; and surface antigens CD90/CD11a by quantitative real-time PCR and according to clinical parameters (plaque index, BOP, PD, DMFT, CAL). Relative gene expression was determined using the ∆∆CT method. Results The mean BOP values (p = 0.001) and PD (p = 0.000) were significantly higher in the CD group compared to controls. Expression of IL-10 was significantly higher in the CD (p = 0.004) and UC groups (p = 0.022). Expression of MMP-7 was significantly higher in the CD group (p = 0.032). IBD patients treated with TNF inhibitors (p = 0.007) or other immunosuppressants (p = 0.014) showed significant overexpression of IL-10 compared to controls. Conclusion Different expression levels of IL-10 and MMP-7 were detected in plaque samples from IBD patients. As only BOP was significantly increased, we conclude that no clinical impairment of periodontal tissue occurred in IBD patients. Clinical relevance With the worldwide increasing incidence of IBD, it is important to obtain insights into the effects of the disease on the oral cavity. The study was registered (01.09.2020) at the German clinical trial registry (DRKS00022956). Clinical trial registration The study is registered at the German clinical trial registry (DRKS00022956).

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