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NCT ID: NCT04791878 Recruiting - Clinical trials for Perianal Fistula Due to Crohn's Disease (Disorder)

Study of Mesenchymal Stem Cells for Pediatric Perianal Fistulizing Crohn's Disease

Start date: April 1, 2021
Phase: Phase 1
Study type: Interventional

This study plans to enroll 10 patients aged 13-17 years of age with refractory perianal fistulizing disease. Patients will be treated by direct injection to the fistula tract(s) with 75 million allogeneic bone marrow derived mesenchymal stem cells at baseline and again after 3 months if not completely healed.

NCT ID: NCT04793061 Recruiting - Metastatic Cancer Clinical Trials

Circulating Tumor DNA as Marker for Response to Antineoplastic Treatment of Metastatic Cancer (FLUIDO)

FLUIDO
Start date: April 1, 2021
Phase:
Study type: Observational

Early monitoring of antineoplastic treatment benefit is a central medical need. Radiologic assessment for documentation of response is done after several months of treatment usually. This implies that patients not responding are exposed to unnecessary toxicity. According to several reports showing the correlation of the amount of circulating tumour DNA with tumour burden we aim to investigate its early dynamic change at the beginning and during antineoplastic treament until radiologic response assessment. Blood samples necessary for that are taken within the scope of clinical routine care. We hypothesize that the changes of circulating tumour DNA correlate with the radiological findings.

NCT ID: NCT04794257 Recruiting - Surgery Clinical Trials

NerveTrend vs. i-IONM in Prevention of Recurrent Laryngeal Nerve Events During Bilateral Thyroid Surgery.

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

The aim of this study is to compare two distinct modes of NIM Vital application in thyroid surgery: i-IONM vs. NerveTrend mode with respect to prevalence of early postoperative RLN injury. The hypothesis explored in this study is that NerveTrend mode may be more accurate than conventional i-IONM mode in intraoperative identification of impending neural injury and in prognostication of postoperative glottis function in monitored bilateral thyroid surgery. Hence, NerveTrend mode may be considered a bridge between i-IONM and c-IONM modes, and particularly in health care environments with limited financial resources it can be considered a substantial step forward representing a modern alternative to the c-IONM technique and providing benefits over conventional i-IONM mode. A prospective, randomized study with 2 arms: i-IONM vs. NeveTrend mode (n=132 patients and 264 nerves at risk, each). The primary outcome measure is prevalence of recurrent laryngeal nerve (RLN) injury (%) on postoperative day 1 assessed by direct laryngoscopy.

NCT ID: NCT04799236 Recruiting - Clinical trials for Mucosal Leishmaniasis

Treatment of Mucosal Bolivian Leishmaniasis

Start date: April 1, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this protocol is to conduct a randomized comparison of the efficacy and tolerance of miltefosine, LAMB, and pentavalent antimony for the treatment of mucosal leishmaniasis. With such controlled pharmacodynamic data, and additional considerations of administrative convenience (oral >>IV) and cost, we hope that it will be possible for policy makers, treatment professionals, and patients to choose the most appropriate therapy for ML.

NCT ID: NCT04799379 Recruiting - Clinical trials for Postoperative Sepsis

Microporous Polysaccharide Hemospheres (MPH) Improving Outcome After Rectal Surgery

EPHAS
Start date: April 1, 2021
Phase:
Study type: Observational [Patient Registry]

Multi-center, prospective, cohort study, of patients scheduled for elective rectal surgery who received absorbable hemostatic powder to assess whether it can improve patient postoperative outcomes, reduce usage of drains and prove to be cost-effective. This cohort will be compared to a previously studied cohort using drains (Power and IMPRICA study) with comparable patient characteristics. The primary endpoint of the study is: postoperative pelvic sepsis within 60 postoperative days including anastomotic leakage, pelvic abscess and peritonitis. Secondary endpoints: postoperative morbidities, rate of reoperation and length of hospitalization.

NCT ID: NCT04799626 Recruiting - Elderly Infection Clinical Trials

Population Pharmacokinetics and Dosage Individualization of Antibiotics in Elderly Patients

Start date: April 1, 2021
Phase:
Study type: Observational [Patient Registry]

The investigator's purpose is to study the pharmacokinetics and pharmacodynamics of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc in elderly ICU patients and recommend an individual dosage regimen of those antibiotics.

NCT ID: NCT04799743 Recruiting - Covid-19 Clinical Trials

The Anti-fibrotic Therapeutic Effects of Resveratrol for Discharged COVID-19 Patients

HKCOVID19Res
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

A randomized controlled trial (RCT) will be conducted to evaluate the anti-fibrotic therapeutic effects of resveratrol on the clinical symptoms in discharged COVID-19 patients.

NCT ID: NCT04801004 Recruiting - Clinical trials for Peripheral Arterial Disease

A Real-world Study to Evaluate the Primary Patency and Freedom From TLR of Endovascular Treatment in TOSAKA III In-stent Restenosis of Lower Extremity Femoropopliteal Artery.

FP-Restore
Start date: April 1, 2021
Phase:
Study type: Observational [Patient Registry]

This study is a prospective, multi-center, real world, observational study, which aims at evaluating the safety, efficacy and economic cost of endovascular treatments for endovascular therapies in tosaka III (totally occluded) in-stent restenosis.It is estimated that 300 subjects diagnosed with tosaka III in-stent restenosis and receive endovascular treatments will be enrolled in nine centers from April 2021 to December 2022 nation-widely. All the subjects will be under follow-up for 24 months. There is no restriction on the endovascular techniques. The primary outcomes include clinical-driven freedom from TLR at 24 months.

NCT ID: NCT04801238 Recruiting - Pancreatitis Clinical Trials

preGallstep - A Clinical Pilot Trial

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

In Denmark, more than 7500 cholecystectomies are performed every year. Common bile duct gallstones (CBDS) are found in 3.4% to 18% of patients undergoing cholecystectomy. A two-step approach including endoscopic retrograde cholangiography (ERC) with stone extraction and papillotomy with subsequent laparoscopic cholecystectomy has become gold standard for treatment of CBDS in Denmark. However, ERC is associated with a high risk of complications and more than 50% of patients require multiple ERCs. Recent meta analyses find that a one-step approach might be superior in terms of safety, CBDS clearance rate, hospital stay, operative time, hospital cost and stone recurrence, but much more data is needed. The preGallstep trial is an investigator-initiated multicentre randomised clinical pilot trial with blinded outcome assessment investigating a novel one-step laparoscopic cholecystectomy with common bile duct exploration and stone extraction versus conventional two-step endoscopic retrograde cholangiography with stone extraction plus a subsequent laparoscopic cholecystectomy for patients with CBDS. After enrolment, the participant will be randomised to one of the two treatment approaches. Adult patients with imaging confirmed CBDS are eligible for inclusion. Potential postoperative complications will be assessed within 90 days following the procedure. The primary outcome is the proportion of serious adverse events (corresponding to a Clavien-Dindo score II or above) requiring re-intervention within 90 days of the initial procedure. This outcome will be used for a future sample size calculation. The sample size estimate, the inclusion rate and the estimated length of subsequent trial will be used to determine the feasibility of a large pragmatic and confirmatory trial. We hypothesize that the one-step approach will significantly reduce the risk of complications and number of treatments needed thereby making a difference to hundreds of people in Denmark each year.

NCT ID: NCT04801342 Recruiting - Clinical trials for Metastatic Malignant Neoplasm to Brain

Neurocognitive Outcome of Bilateral or Unilateral Hippocampal Avoidance WBRT With Memantine for Brain Metastases

Start date: April 1, 2021
Phase: Phase 2
Study type: Interventional

Brain metastases are the most common brain tumors in adults. It is estimated that around 10-30% of cancer patients would develop brain metastases during the course of their illness. Whole brain radiotherapy (WBRT) is the treatment of choice for the majority of patients with brain metastases. WBRT yields high radiologic response rate (27~56%) and is effective in rapid palliation of neurologic symptoms as well as prolongs time to neurocognitive function decline caused by intracranial lesions. By using conventional fractionation, more than one- third of patients developed late neurocognitive toxicity while memory impairment was the most common symptom. The incidence is even higher when a formal and sensitive neurocognitive assessment was prospectively evaluated. With more long-term survivors nowadays, it has become increasingly important to minimize neurocognitive function decline and maintain quality of life in patients with brain metastasis. The function of hippocampus is cooperation in learning, consolidation and retrieval of information and essential for formation of new memories. Bilateral and unilateral radiation injury of the hippocampus is known to alter learning and memory formation. Several preclinical studies support the hypothesis of hippocampus-mediated cognitive dysfunction by ionizing radiation. Clinical studies show increase in radiation dose to hippocampus is associated with subsequent neurocognitive function impairment in adult and pediatric patients. Furthermore, the result of phase III randomized trials suggested hippocampal avoidance plus Memantine significantly reduce the risk of neurocognitive impairment at 6 months from 68.2% in control arm with standard WBRT to 59.5% in experimental arm. In the investigator's prior investigation, patients received conformal WBRT with bilateral hippocampal avoidance also had significant less declines in verbal memory at 6 months. Previous studies showed the right and left hippocampus exert different neurocognitive functions. Several retrospective studies also demonstrated that the radiation dose to the left hippocampus is more related to neurocognitive impairment. Planning study and investigation showed that by avoiding the left hippocampus alone, the radiation dose to the spared unilateral hippocampus is further decreased. In present study, a single blind randomized phase II trial is designed to investigate the effectiveness of neurocognitive function preservation using conformal WBRT with bilateral or unilateral hippocampal avoidance and memantine.