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NCT ID: NCT04846543 Recruiting - Forearm Fracture Clinical Trials

Bioresorbable Intramedullary Nailing of Forearm Fractures

BRINFF
Start date: March 1, 2021
Phase: N/A
Study type: Interventional

The Activa IM-Nailâ„¢ is used in the fixation of forearm fractures with cast to achieve a level of reduction and stabilisation that is appropriate to the age of the child. The post-market clinical follow-up study will be performed to identify the residual risk related to re-fracture and to determine its impact to the risk/benefit ratio of Activa IM-Nailâ„¢.

NCT ID: NCT04843488 Recruiting - Dental Implants Clinical Trials

Effectiveness of Different Membrane Applications in Vertical Ridge Augmentation - Randomized Clinical Trial

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

This RCT study investigates if there is any difference in complication rate between perforated d-PTFE mesh vs perforated d-PTFE mesh covered with a native collagen membrane. The primary endpoint is complication rate. The secondary endpoints are regeneration rate and pseudoperiosteum formation.

NCT ID: NCT04842968 Not yet recruiting - Colorectal Cancer Clinical Trials

Ex Vivo Intraarterial Methylene Blue Injection Improve Nodal Staging Accuracy in Colorectal Cancer

MB
Start date: April 15, 2021
Phase: N/A
Study type: Interventional

Nodal staging holds both important prognostic and predictive value at colorectal cancer. Regional lymph nodes are located close to the primary tumor in the mesocolon / mesorectum. Current pathology and oncology standards require a separate examination of at least 12 lymph nodes each case to fulfill staging "accuracy" criteria. In order to reach this number of lymph nodes, a precise surgical technique (total mesorectal excision or complete mesocolic excision), as well as a thorough pathological specimen work-up is needed. The aim of the study is to investigate, if ex vivo intra-arterial methylene blue injection by the surgeon can help improving nodal harvesting effectivity of the pathologist, hence leading to a better staging and hopefully even to a better outcome in the long run. In 2014-2015 two surgical centers randomised resected colorectal specimens in 1:1 ratio to methylene-blue injection arm and control (no injection) arm in a total of 200 consecutive cases. Both pathologic and oncologic treatment were led regardless of the injection, reports were just routinely saved in the routine medical documentation. This retrospective study is designed to recall patient-related, surgery-related factors, as well as pathology reports including nodal staging from the medical databases. The investigators aim to find correlation between methylene blue "staining" and lymph node yield. In addition, the investigators plan to crossmatch methylene blue injection, as a process, with long term survival of the patients.

NCT ID: NCT04840667 Not yet recruiting - Fabry Disease Clinical Trials

A Study of Replagal in Treatment-naïve Adults With Fabry Disease

Start date: July 9, 2021
Phase: Phase 3
Study type: Interventional

In this study, adults with Fabry Disease who have not had any treatment for this condition will be treated with Replagal. The main aim of the study is to check if Replagal improves kidney function and heart structure of participants with Fabry Disease. Participants will receive one Replagal infusion every other week for up to 104 weeks. They will visit the clinic every 12 to 14 weeks during treatment with a follow-up visit 2 weeks after treatment.

NCT ID: NCT04840238 Recruiting - Clinical trials for Vitamin D Deficiency

30000 IU Per Week Vitamin D Treatment in PCOS Patients

Start date: December 8, 2016
Phase: Phase 2
Study type: Interventional

This is a human, II/b phase, multicentre, randomised, double blind, placebo-controlled study to assess the safety and the efficacy of a weekly administered dose of 30,000 IU vitamin D (colecalciferol) in deficient patients diagnosed with PCOS. Investigational products: 30.000 IU vitamin D or placebo administered once a week for 12-weeks-long period, followed by a 12-week-long open label treatment 30.000 IU vitamin D in a follow-up period. Each participant should be checked for regular dietary Ca intake and to assure the optimal calcium level the supplementation is provided with a commercially available Citrocalcium 200 mg tablets. Setting: I. Baseline and screening period: Baseline period considered as when the exogenous Vitamin D intake should not exceed the level of 1000 IU intake per day or a total 5000 NE per week dosages applied (in forms of any Vitamin D3 medication or multivitamin products) at least for 30 days prior the assessment made. II. Double-blind treatment period: Once a week per os applied Vitamin D or placebo treatment for 12 weeks according to randomisation of trial subjects in a 1:1 assignment. By the end of this period an interim assessment will be performed based on the analysis of primary efficacy parameters, stratification to responder and non-responder groups. III. Open label and follow-up phase: An open-label 30000 IU of Vitamin D treatment on weekly basis. (Vitamin D3 Pharma Patent 30000 IU tablets) for additional 12 weeks and continue with the follow-up assessments. A compassionate use of patient diary for additional 26 weeks. Objectives: Primary objectives: to assess the efficacy as a recovery of ovarian function based on progesterone levels and menses diary in at least 20% of trial subjects, compared to placebo treated group Secondary Objectives: assess the efficacy and safety of orally administered vitamin D treatment by the changes in 25(OH) D levels in PCOS patients. Explore the changes in Ovarian-morphology based on the results of standard TVUS Imaging: detection of adverse drug reactions during treatment periods, by frequency and distribution compared to follow-up periods and placebo group. Anticipated participants: 168

NCT ID: NCT04829318 Not yet recruiting - Clinical trials for Depressive Disorder, Major

A Long-Term Extension Study for Participants With Treatment-resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment

ESCAPE-LTE
Start date: April 26, 2021
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to assess the long-term safety and tolerability of esketamine nasal spray in combination with a selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) in participants who have completed 32 weeks of esketamine nasal spray treatment in Study 54135419TRD3013 (NCT04338321).

NCT ID: NCT04824716 Completed - Clinical trials for Acute Myocardial Infarction With ST Elevation

Analysis of the Efficacy of Cardiac Ischemic Postconditioning With New Clinical End-points Using Novel Biomarker.

Start date: January 14, 2013
Phase: N/A
Study type: Interventional

The aim of the present study was to investigate the efficacy of ischemic postconditioning in acute myocardial infarction patients. The safety of patients enrolled in the study was ensured during the entire study. Over 18 years old men and women were enrolled in the study who arrived to 2 of the most acknowledged Hungarian cardiac centres due to acute myocardial infarction and fulfilled all inclusion and exclusion criteria as per protocol. Patients in the order of their arrival were assigned either to control or post conditioned groups by turns. Medical treatment of the control group was done according to standard Percutaneous Coronary Intervention (PCI) guidelines, i.e. there was no further intervention after artery opening for 8 minutes, then stenting was performed. In the post conditioned group, after reperfusion has been confirmed, the coronary artery was occluded by inflation of the stent balloon 4 times (for 1-1 minute) followed by 1-1-minute reperfusion repeatedly to induce ischemic postconditioning. Postconditioning procedure was followed by stenting as in the control group. All other interventions and treatments in both patient groups were identical according to guidelines.

NCT ID: NCT04824092 Not yet recruiting - Clinical trials for Diffuse Large B-cell Lymphoma

Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients

frontMIND
Start date: April 2021
Phase: Phase 3
Study type: Interventional

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL

NCT ID: NCT04823572 Recruiting - Clinical trials for Periodontal Diseases

Treatment of Periodontal Intrabony Defects With A-PRF or OFD

Start date: February 1, 2020
Phase: N/A
Study type: Interventional

The aim of this randomized clinical trial was to clinically evaluate and compare the healing of intrabony defects after treatment with advanced platelet-rich fibrin (A-PRF+) toped flap debridement (OFD) in periodontitis patients.

NCT ID: NCT04811768 Completed - Clinical trials for Maxillary Sinus Augmentation

Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation

Start date: March 1, 2017
Phase: Phase 4
Study type: Interventional

The aim of the present prospective randomized controlled study is to clinically and histologically investigate the safety and efficacy of bony wall repositioning compared to rotary window preparation with membrane coverage in maxillary sinus floor augmentation.