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NCT ID: NCT03067103 Not yet recruiting - Pain, Postoperative Clinical Trials

Comparison of Peritonsillar Infiltration of Tramadol Ketamine and Placebo on Pediatric Posttonsillectomy Pain

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

Adenotonsillectomy is one of the most common ambulatory surgical procedures performed to children. Tonsillectomy or adenotonsillectomy have a high incidence of postoperative pain. There is still debate about the optimal analgesia for this common surgical procedure. Different methods have been described and used to reduce pain including; improved intraoperative anesthetic pain regimens, use of corticosteroids, adjustment of surgical technique, and intraoperative local anesthetic injection. Intraoperative local anesthetic is a preventive or preemptive analgesia which is the analgesia given before painful stimuli to prevent the subsequent pain. The main goal of the preventive analgesia is the pain relief with minimum side effects. The role of local anesthetic infiltration in the reduction of postadenotonsillectomy pain is still controversial. The objective of this study is to investigate and compare the effectiveness of preincisional peritonsillar infiltration of ketamine and tramadol for post-operative pain on children following adenotonsillectomy. This is prospective, double-blinded randomized study.

NCT ID: NCT03065803 Not yet recruiting - Clinical trials for Bone Resorption After Tooth Extraction

Buccal Plate Expansion Technique Versus Guided Bone Regeneration Technique in Socket Preservation in the Aesthetic Zone.

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Introduction and evaluation of a new technique for socket preservation involving internal expansion of the buccal plate of the extraction socket using internal flapless corticotomy and bone grafting the extraction socket with application of bioresorbable membrane biomaterials in comparison with the conventional guided bone regeneration technique for a conventional socket preservation method hoping to maintain or improve hard and soft tissue contour of the alveolar ridge post tooth extraction.

NCT ID: NCT03063931 Not yet recruiting - Clinical trials for Neuropathic Pain Induced by Mastectomy

Pain and Magnesium

Start date: March 2017
Phase: Phase 2
Study type: Interventional

In breast cancer patients undergoing a mastectomy, the aim of this study is to evaluate if the magnesium administered for 6 weeks starting two weeks before the surgery induces a decrease of pain intensity one month post-mastectomy compared to the placebo group.

NCT ID: NCT03059784 Not yet recruiting - Clinical trials for Percutaneous Coronary Intervention

APP-based Multifaceted Management After PCI

Start date: March 2017
Phase: N/A
Study type: Interventional

High rates of recurrent cardiovascular events and readmission after percutaneous coronary intervention (PCI) are important issues. Guidelines emphasize rehabilitation and secondary prevention. But many patients are lack of effective management after PCI.This study is aimed to examine the effect of mobile application (APP)-based multifaceted management on the improvement of long-term care after PCI.

NCT ID: NCT03057912 Not yet recruiting - Clinical trials for Human Papillomavirus-Related Malignant Neoplasm

A Safety and Efficacy Study of TALEN and CRISPR/Cas9 in the Treatment of HPV-related Cervical Intraepithelial NeoplasiaⅠ

Start date: January 15, 2018
Phase: Phase 1
Study type: Interventional

This is an open-label and triple cohort study of the safety and efficacy of TALEN and CRISPR/Cas9 to possibly treat HPV Persistency and human cervical intraepithelial neoplasiaⅠwithout invasion.

NCT ID: NCT03056586 Not yet recruiting - Cystocele Clinical Trials

The Effect of Pessary Post Vaginal Prolapse Repair, for One Month, to Reduce the Recurrence Rate of Prolapse

pfgp
Start date: March 20, 2017
Phase: N/A
Study type: Interventional

Genital prolapse is a common complain. 30-40% of women will complain of uterine prolapse or cystocele or rectocele, or mixed. About half of them will require surgical repair for the prolapse, with or without hysterectomy. Of these patients about 30-40% will have recurrence of the prolapse, which in some cases requires second operation. In this study the investigators want to investigate whether a vaginal pessary inserting in the end of the primary surgery, for 4 weeks, will reduce the recurrence rate.

NCT ID: NCT03055637 Not yet recruiting - Clinical trials for Fistula of Soft Palate (Disorder)

Evaluation of the Incidence of Palatal Fistula in Furlow Double-opposing Z-plasty vs. Two-flap Palatoplasty for Cleft Palate Repair

Start date: February 19, 2017
Phase: N/A
Study type: Interventional

Evaluation of the incidence of palatal fistula in Furlow double-opposing z-plasty versus two-flap palatoplasty for cleft palate repair.

NCT ID: NCT03053856 Not yet recruiting - Clinical trials for Stage IIIA Non-small Cell Lung Cancer

Adjuvant Pembrolizumab in N2 Positive Non-small Cell Lung Cancer Patients

Start date: February 14, 2017
Phase: Phase 2
Study type: Interventional

This is a single arm, single center phase II study of adjuvant pembrolizumab in N2 positive non-small cell lung cancer (NSCLC) patients treated with neoadjuvant concurrent chemoradiotherapy followed by curative resection. Patients will receive pembrolizumab 200 mg every 3 weeks for up to 24 months. The primary objective of this study is to assess the efficacy of adjuvant pembrolizumab treatment in terms of disease-free survival (DFS; per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by the investigator). The baseline assessment is part of the screening procedures and should be performed within 0 to 14 days before the start of study drug. The imaging modalities used for RECIST 1.1 assessment will be CT of chest or PET-CT if indicated. Follow-up chest CT for all patients will be assessed every 12 weeks for the first year, every 16 weeks for the second year, every 6 months for the third year, and every year thereafter. In subjects who discontinued study therapy without documented recurrence, every effort should be made to continue monitoring their disease status. If an unscheduled assessment is performed, and the patient has not progressed, every attempt should be made to perform the subsequent assessments at their scheduled visits. RECIST 1.1 scans will be analyzed by the investigator on site; a central review will not be conducted. Following completion or discontinuation of study drug, patients will enter a follow-up period. Once a patient has had objective relapse recorded and has discontinued study drug, the patient will be followed for survival status every 3 months until death, withdrawal of consent or the end of the study. Patients will also be requested to provide tumor samples from diagnostic (obtained before neoadjuvant CCRT) and surgical specimens for exploratory biomarker study. Sample provision is not optional, subject to a specific consent.

NCT ID: NCT03053206 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia, in Relapse

A Prospective, Interventional Study Assessing Response to Cytarabine, Daunorubicin and Etoposide (ADE) for First Relapse of Paediatric Acute Myeloid Leukemia

Start date: February 15, 2017
Phase: Phase 2
Study type: Interventional

One-third to one-half of patients with AML relapse and in general relapsed AML patients have a poor prognosis. The treatment of relapsed AML consists of induction chemotherapy followed by Allogenic Stem Cell Transplant (ASCT). However, at present there is no standard salvage chemotherapy regimen for relapsed AML, as no study has shown any one regimen to be significantly superior. Anthracyclines, Fludarabine, Etoposide and cytarabineare active agents in AMLand have been used as monotherapy and in combination in refractory and relapsed AML patients. According to previous studies the present CR rate of different regimens ranges from 50-70%. A retrospective analysis (unpublished) conducted at IRCH, AIIMS on relapsed AML patients treated with ADE (Cytarabine, Daunorubicin and Etoposide) chemotherapy showed the CR rates of approximately 70%. Therefore, we have planned this study to test the efficacy and toxicity of ADE induction chemotherapy in relapsed AML patients in a prospective manner.

NCT ID: NCT03051152 Not yet recruiting - Gastric Cancer Clinical Trials

D1 Versus D2 Lymphadenectomy in High Risk Elderly With Gastric Adenocarcinoma

LELEGA
Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Background: Literature often shows limited and discordant data regarding the prognostic value of age in gastric-cancer patients. Generally, disease-specific survival does not seem to be worse in the elderly when compared with younger patients, and therefore gastrectomy with extended lymphadenectomy for non-early tumors is considered the "standard" surgical therapy for all of operable patients, despite any age- or comorbidity-related limitations. Recent trials reported a survival benefit for extended nodal dissection compared with the more limited method, but some Authors found age (and comorbidities) to be a relevant predictor of postoperative complications, conditioning the safety of the surgical procedure itself. Methods/Design: The LELEGA Trial (Limited versus Extended Lymphadenectomy in high risk Elderly with Gastric Adenocarcinoma) is a randomized, clinical multicenter trial. All patients >75 years and with Charlson Comorbidity Score >5 with resectable M0 gastric cancer are eligible for inclusion and randomization. The primary endpoint is 5-year Disease-Specific Survival (DSS). Secondary endpoints include 5-year Overall Survival (OS) and postoperative complications classified according to Clavien-Dindo. Assuming an alpha (two-sided) of 5%, 232 patients per group are necessary to achieve an 80% power to detect a 13% survival difference (from 56% to 69%) between groups. Discussion: LELEGA trial is a prospective, multicenter randomized study to define optimal extent of lymphadenectomy (extended versus limited) in elderly and high-comorbidity gastric cancer patients.