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NCT ID: NCT04648033 Completed - Clinical trials for Locally Advanced Non-Small Cell Lung Cancer

Atovaquone With Radical ChemorADIotherapy in Locally Advanced NSCLC

ARCADIAN
Start date: December 7, 2020
Phase: Phase 1
Study type: Interventional

This is a phase I, single arm, open-label trial that will utilise a Time To Event Continual Reassessment Method (TiTE-CRM) to determine the maximum tolerated dose (MTD) of atovaquone in combination with concurrent CRT in NSCLC. Twenty evaluable participants will be recruited at three centres.

NCT ID: NCT04647981 Completed - Clinical trials for Non-Invasive Bladder Urothelial Carcinoma

Diagnostic Performance Evaluation Study of the Xpert® Bladder Cancer Monitor Test.

Xpert Bladder
Start date: May 22, 2019
Phase:
Study type: Observational

Non-muscle invasive bladder tumor is a condition that can recur with a risk of progression to an infiltrating tumor of the muscle. Regular follow-up is therefore essential to detect any recurrence or progression of the disease as early as possible. Currently, the monitoring of this type of tumor is done by cystoscopy (examination that allows visualization of the bladder wall) associated with urinary cytology (analysis of urine to detect an abnormality). These examinations have their limits, they may not detect certain types of tumors or may be painful. To reduce the number of cystoscopies and replace urinary cytology, several urinary markers have been developed in recent years. This is the case of the Xpert® Bladder Cancer Monitor test, which is a non-invasive, in vitro diagnostic urine test dedicated to the monitoring of patients with bladder cancer. The purpose of this study is to evaluate the diagnostic performance of the Xpert® Bladder Cancer Monitor test for the detection of bladder tumor recurrence, compared to reference tests.

NCT ID: NCT04647877 Completed - Clinical trials for Chronic Idiopathic Axonal Polyneuropathy

Phenytoin Cream for the Treatment of Neuropathic Pain

EPHENE
Start date: September 17, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Objectives: The main objective is to evaluate the efficacy and safety of phenytoin cream in patients with neuropathic pain due to chronic idiopathic axonal polyneuropathy (CIAP). The second objective is to determine the predictive value of a double-blind placebo-controlled response test (DOBRET) to identify sustained responders. Study design: This is a 6-week enrichment randomized double-blind, placebo-controlled cross-over trial evaluating phenytoin cream in 84 participants with painful CIAP, whereafter an open label extension phase is offered with phenytoin 20 percent cream for up to one year. At baseline a DOBRET with phenytoin 10 percent and placebo cream will be performed in each study participant to stratify participants according to their response to the DOBRET before entering the double-blind cross-over phase. DOBRET positive participants are those who experience at least two points pain reduction on the 11-point numerical rating scale (NRS) on the phenytoin 10 percent cream applied area within 30 minutes and at least one-point difference in pain reduction on the NRS between phenytoin 10 percent and placebo cream applied area, in favour of the former. Participants will receive three treatments in a double blind fashion and in a randomized order: phenytoin 10 percent, phenytoin 20 percent and placebo cream. The duration of each treatment period is two weeks. Participants will cross-over two times to each of the other treatments. The study does not have wash-out periods between treatments, because the mean duration of analgesic effect after an application is expected to be less than nine hours. A blood sample will be collected at the end of the second week of the first treatment period to test for phenytoin plasma levels. Study population: The investigators aim to include 84 participants, age 40 years or older, who have been diagnoses with painful CIAP at the University Medical Center Utrecht and fulfil the inclusion criteria and have given written informed consent. Interventions: Phenytoin cream in concentrations of 10 percent and 20 percent cream compared to placebo cream. Primary endpoint: Change in pain intensity measured on the NRS between baseline and week 2 for phenytoin 20% cream versus placebo cream.

NCT ID: NCT04647721 Completed - Clinical trials for Correction of Moderate to Severe Nasolabial Folds (NLFs)

Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Moderate to Severe Nasolabial Folds

Start date: January 13, 2021
Phase: N/A
Study type: Interventional

Effectiveness: The purpose of this study is to demonstrate the non-inferiority of Radiesse (CaHA) to Restylane (HA) following subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as NLFs. Safety: To evaluate the incidence and type of adverse events and serious adverse events.

NCT ID: NCT04647617 Completed - Clinical trials for Twelve Week Quantitative Weight Bearing of Resistance Training Effect on Glycemic Control and Muscle Strength

Effects of 12- Weeks of Quantitative Weight-bearing Progressive Resistance Exercise Training on Glycemia Control and Improving Muscle Strength With Type 2 Diabetes Combine Pre-sarcopenia.

Start date: August 24, 2020
Phase: N/A
Study type: Interventional

According to the International Diabetes Federation (IDF) in 2017 investigator found that the incidence of type 2 diabetes is currently 425 million people aged 20 to 79 in the world, and this data will increase o 629 million at 2045, The etiology of more than 90% is related to aging, it has become a serious challenge to public health. Sarcopenia is a newly noticed severe syndrome characterized by reduced walking speed, decreased grip strength, and decreased muscle mass. Patients with type 2 diabetes are at risk of sarcopenia and are those with normal blood sugar. One of the main ways to improve the face of sarcopenia is to exercise intensity. By carrying out a gradual training plan instead of using different weights, it will lead to muscle hypertrophy and increase in muscle strength to achieve muscle gain. In view of the fact that the commercially available sandbags are cheap and easy to obtain, the weight is fixed, and the use variability is high, it is expected to introduce quantitative weight-bearing progressive exercises in type 2 diabetes and have symptoms of muscle loss to improve muscle mass, and to control blood sugar. The quality of life can have better benefits.

NCT ID: NCT04647383 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obstructive Sleep Apnea, and in Adult and Elderly Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease

Start date: January 6, 2021
Phase: Phase 1
Study type: Interventional

The primary purpose of the study is to determine whether lemborexant increases the apnea hypopnea index (AHI) on Day 8 of treatment in adult and elderly participants (adults greater than or equal to [>=] 45 to less than [<] 65 years; elderly >=65 to 90 years) with moderate to severe obstructive sleep apnea (OSA) compared with placebo, and using pulse oximetry determine whether lemborexant decreases the peripheral oxygen saturation (SpO2) during total sleep time (TST) on Day 8 of treatment in adult and elderly participants (adults >=45 to <65 years; elderly >=65 to 90 years) with moderate to severe chronic obstructive pulmonary disease (COPD) compared with placebo.

NCT ID: NCT04647344 Completed - Clinical trials for Lung Cancer Non-Small Cell Stage IIIB/IIIC/IV

A Study of AK104 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Start date: November 24, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase Ib/II , open-label, multicenter single arm study designed to evaluate the efficacy, safety, tolerability, pharmacokinetic (PK), and immunogenicity of AK104 combined with Carboplatin and Pemetrexed/ Paclitaxel as first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer.

NCT ID: NCT04647045 Completed - Clinical trials for Irritable Bowel Syndrome With Constipation

An Evaluation of Cultured Milk Drink on Immune Status of Patients With Irritable Bowel Syndrome: Constipation Predominant

Start date: May 2, 2017
Phase: N/A
Study type: Interventional

Our previous work on the use of probiotics improved the clinical symptoms in irritable bowel syndrome with constipation-predominant. This study would like to explore further use of probiotics in the immune system of the patients with irritable bowel syndrome.

NCT ID: NCT04645082 Completed - Clinical trials for Ankle; Injury, Superficial, Multiple (With Foot)

Effect of Q-angle, Lateral Distal Tibial Angle and Proximal Muscle Torque on Ankle Injury

Start date: March 12, 2019
Phase:
Study type: Observational [Patient Registry]

This study was undertaken to examine the effect of Q angle, lateral distal tibial angle (LDTA), and lower extremity isometric muscle torque on ankle sprain. Among 40 participants with ankle sprain, Q angle and LDTA measurements in both extremities were performed using X-ray images, while the muscle strength in gluteus maximus, gluteus medius, and quadriceps femoris were determined with hand held dynamometer, and the muscle torque was estimated by multiplying these values with the distance to the joint center. The obtained data were analyzed by separation analysis. No significant relationship was found between the Q angle and ankle sprain (p> 0.05). A strong positive correlation was found between LDTA and ankle sprain (p = 0.01). A strong negative correlation was found between quadriceps femoris muscle strength, gluteus medius muscle strength and gluteus maximus muscle strength with ankle sprain (p <0.001, p = 0.001, p <0.001, respectively). A strong negative relationship was found between quadriceps, gluteus medius and gluteus maximus muscle torques with ankle sprain (p <0.001, p = 0.011, p = 0.002, respectively). As suggested by the discrimination analysis, independent variables that contributed most to ankle injury included the gluteus maximus muscle torque (MAXIMUSTORQ) (.906), gluteus medius muscle torque (MEDIUSTORQ) (. 494), lateral distal tibial angle (.436) and quadriceps femoris muscle. torque (QUADRTORQ) (. 341), respectively. In conclusion, strengthening the quadriceps femoris, gluteus medius and gluteus maximus muscles may be suggested as an effective strategy to prevent ankle sprain. It may be helpful to pay attention to individuals with high LDTA to prevent ankle sprains.

NCT ID: NCT04644783 Completed - Pediatric Disorder Clinical Trials

Novel Blood Test to Predict Safe Foods for Infants and Toddlers With Food Protein-induced Enterocolitis Syndrome (FPIES)

Start date: October 8, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to validate a blood test that can identify safe foods for food protein-induced enterocolitis syndrome (FPIES). This study proposes a solution to the problems of FPIES by developing a new blood assay that screens a large number of foods (more than 20) in a culture plate. If this blood test is successful it may be able to identify safe foods more quickly. The study will recruit 10 participants that will have more than 2 trigger foods.