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NCT ID: NCT04712435 Not yet recruiting - Clinical trials for Hematopoietic Stem Cell Transplant (HSCT)

Efficacy of N-acetylcysteine Versus Placebo as Prophylaxis of Sinusoidal Obstruction Syndrome in Patients Undergoing Hematopoietic Stem Cell Transplantation

ALISON
Start date: April 2021
Phase: Phase 2
Study type: Interventional

Sinusoidal obstruction syndrome (SOS) or hepatic veno-occlusive disease (VOD) is a serious complication that occurs, most often occurring in patients undergoing hematopoietic stem cell transplantation (HSCT), especially in its first thirty days. The morbidity and mortality in this syndrome are considerable, since severe SOS is associated with a mortality of more than 90% in the first hundred days of HSCT. Some risk factors are modifiable, especially those related to transplantation, but when non-alterable factors are present, preventive measures are needed that can reduce the incidence and / or severity of SOS.

NCT ID: NCT04711980 Not yet recruiting - Clinical trials for Diabetic Peripheral Neuropathy Type 2

Post-marketing Evaluation of Mudan Granule Intervention on Type 2 Diabetic Peripheral Neuropathy

Start date: June 2021
Phase: Early Phase 1
Study type: Interventional

Background: Diabetic peripheral neuropathy (DPN) is a common and disabling chronic microvascular complications in patients with type 2 diabetic Mellitus (T2DM) that is characterized by nerve damage, affecting at least half of patients diagnosed with diabetes. It has been reported that DPN significantly contributes to the increased morbidity with diabetic foot ulcers by 60% and amputation by 85% that seriously threaten the quality of life. Mudan granule, a traditional Chinese medicinal preparation, is widely used in clinical practice for DPN in China. Evidence from clinical and preclinical studies have shown that Mudan granule could relieve symptoms and reduce the incidence of DPN exacerbations. However, the previous studies are of variable quality and poorly standardized,which limits the clinical application of Mudan granule. This study evaluates the efficacy and safety of Mudan granule combined with methylcobalamin in the treatment of type 2 diabetic peripheral neuropathy, providing the highest level of evidence of Mudan granule. Methods and design: A randomized, double-blind, placebo-controlled,parallel-arm, and multi-centric clinical trial design was used based on a co-regimen of methylcobalamin. Subjects who met the inclusion criteria were randomly divided into two groups. The patients in the study group were treated with Mudan granule combined with methylcobalamin, and the patients in the control group were treated with placebo combined with methylcobalamin. The total intervention period is 24 weeks. The sample size was 402 cases. Major evaluation indicators: Michigan Diabetic Neuropathy Score (MDNS) changes, the changes of MDNS were compared between the two groups before and after medication, adopting the evaluation method of difference values. Secondary Evaluation Indicators:(1) nerve conduction velocity changes, the changes in nerve conduction velocity of each nerve were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values. (2)corneal nerve fiber density changes, the changes in corneal nerve fiber density of each mm2 were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values. (3)corneal nerve branch density changes, the changes in corneal nerve branch density of each mm2 were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values. (4)corneal nerve fiber length changes, the changes in corneal nerve fiber length of each mm2 were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values. (5)Toronto Clinical Scoring System (TCSS) changes, the changes of toronto clinical score were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values. (6)Traditional Chinese Medicine(TCM) syndromes efficacy score changes, the changes in TCM syndromes efficacy score were compared between the two groups before and after taking medicine, adopting the evaluation method of difference values. (7) Clinical symptoms score changes, the changes of each of clinical symptoms score were compared between the two groups before and after medication, adopting the evaluation method of difference values. Discussion: We postulate that patients with type 2 diabetic peripheral neuropathy will benefit from therapy with Mudan granule.

NCT ID: NCT04710160 Not yet recruiting - Clinical trials for Clinical Evaluation Including Pain and Swelling

Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Protooth Vs. MTA

Start date: August 2021
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the clinical and radiographic success in pulpotomy using novel fast-setting calcium silicate cement (Protooth) versus MTA in exposed primary molars.

NCT ID: NCT04707365 Not yet recruiting - Colorectal Cancer Clinical Trials

Microenvironment and Immunity of Digestive Cancers - East Paris Multicentric Cohort

MICADO
Start date: March 2021
Phase: N/A
Study type: Interventional

Colorectal and pancreatobiliary cancers are the most common digestive cancers. Their incidence has particularly increased over the last few decades, leading to suspicion that environmental factors are involved. In addition, strategies for the therapeutic management of these cancers are evolving in the context of the development of immunotherapies. Tumor microenvironment is a potential source of new diagnostic, prognostic and predictive markers and new therapeutic targets. The links between tumor microenvironment and modulation of the immune system in colorectal and pancreatobiliary cancers are poorly understood. Molecular classifications have been proposed for these cancers, but their link with immunity and response to treatment remains to be explored. Objective : explore links between molecular subtypes, tumor microenvironment, host (immune system, pre-metastatic niche, intestinal microbiota, metabolism), and survival (prognostic value), response (predictive value) and tolerance (toxicities) to treatments in digestive cancers, in particular colorectal and pancreatobiliary cancers. Method: Retrospective and prospective monocentric cohort study

NCT ID: NCT04705337 Not yet recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

Levosimendan In Ambulatory Heart Failure Patients

LEIA-HF
Start date: January 1, 2021
Phase: Phase 4
Study type: Interventional

The objective of the study is to determine the efficacy of repeated infusions of levosimendan in the group of outpatients with advanced systolic heart failure (HF).

NCT ID: NCT04704778 Not yet recruiting - Orofacial Pain Clinical Trials

Electrostimulation Therapies With Implementation of Multifractal Electromyographic Analysis

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

The objective is to compare the neuromuscular electrical activity and muscle fatigue of the masseter muscles in three groups of patients with different treatments for TMD (GA = Transcutaneous electrostimulation and splint, GB = percutaneous electrostimulation and splint, and GC = Occlusal splint) by means of 6 electromyographic recordings scheduled weekly. The study population will be patients with TMD who will enter the Physiology Laboratory of the Division of Postgraduate Studies and Research (DEPeI) UNAM, admitted during the period from March to December 2021 The selection of the sample will be carried out by convenience sampling which will be carried out based on the clinical evaluation (considering the inclusion and exclusion criteria). The recruitment period will take place during the period from March to December 2021. The selected sample will be divided into three groups (GA = transcutaneous electrostimulation and splint, GB = percutaneous electrostimulation and splint, GC = splint); the allocation by group will be made by means of a randomization in balanced blocks. The total sample size calculated for this study was 84 patients, 28 for each group. The diagnostic process of Temporomandibular Dysfunction (TMD) will be carried out by the Principal Investigator using the Diagnostic Criteria and Investigation of Temporomandibular Disorders (CDI / TMD).

NCT ID: NCT04703218 Not yet recruiting - Clinical trials for Adult With Stroke and Olfaction's Complaint

REEDUCATION OF OLFACTORY DISORDERS AFTER A CEREBRAL VASCULAR ACCIDENT IN ADULTS

RE-OLF
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Study context: The literature identifies more and more research revealing olfactory disorders, with a high frequency after an acquired brain injury. So far, studies have mainly focused on post-traumatic and post-infectious olfactory disorders of the upper airways. There is scarcer data available on the olfactory disorders occurring after stroke. A recent study found 43.6% of patients with a loss of olfactory function after a stroke (2). This type of disorder can have repercussions in everyday life and endanger people, not being able to smell a burning odor or gas fumes. In addition, patients frequently describe loss of pleasure associated with these olfactory disorders (3). Tests allowing the evaluation of these difficulties exist but remain little used in clinical routine (4). These psychophysical tests allow a quantitative analysis of the olfactory capacities of subjects through various measures such as the detection threshold (T SST sub-score), discrimination (D SST sub-score) or the identification of an odor. (SST sub-score I). Some studies have shown a reduction in olfactory disturbances following specific training. Thus, Hummel et al. proposed a self-stimulation protocol to patients whose olfactory dysfunction was due to various aetiologies (post-infectious, post-traumatic or idiopathic) (5). People were to smell 4 scents twice a day for 12 weeks. The results show an improvement in the olfaction of the patients, while no change was noted in the subjects who did not perform the training. Lehrer et al. obtained similar results in patients with head trauma (CT) after 3 months of training (6). However, no study has looked at the effect of specific olfaction training in post-stroke patients. The few data available in the literature suggest that these disorders are common after stroke. Objectives : We propose an open, randomized controlled study, comparing the SST score between the group of patients who received olfactory training and the group who received standard rehabilitation. Material and methods : In the treatment of post-stroke olfactory disorders, we will suggest to patients hospitalized in SSR or followed in consultation to participate in a controlled, randomized open study. All included patients will be assessed using the SST and the modified ASOF quality of life questionnaire (7). After randomization, patients in the treatment group will benefit from a presentation of specific olfaction training. This training consists of smelling 4 scents twice a day using scent sticks, for 12 weeks. At the end of these 12 weeks, a post-protocol evaluation including the SST, the modified ASOF quality of life questionnaire and a measurement of any side effects related to training will be offered. Hypothesis tested: The aim of this work is to evaluate the effectiveness of a specific olfaction training protocol in patients with olfaction disorders following stroke.

NCT ID: NCT04703088 Not yet recruiting - Hypotension Clinical Trials

ONDANSETRON AND EFFECTIVE DOSE IN 50% OF SUBJECTS OF PROPHYLACTIC NOREPINEPHRINE INFUSIONS FOR PREVENTING SPINAL ANESTHESIA-INDUCED HYPOTENSION DURING CESAREAN DELIVERY

Start date: June 2021
Phase: Phase 3
Study type: Interventional

Spinal anesthesia is the preferred technique for elective cesarean section as per ASA guidelines. Hypotension is the main complication of this technique and is secondary to both sympatholysis and its associated decrease in systemic vascular resistance and to the Bezold-Jarisch reflex, which causes hypotension and bradycardia in response to noxious stimuli detected in the cardiac ventricles. In pregnant patients, spinal anesthesia induced hypotension is worsened by compression of the aorta and inferior vena cava by the gravid uterus. In this setting, hypotension could lead to uteroplacental hypoperfusion and fetal distress. In its 2020 guidelines for enhanced recovery after cesarean section, SOAP states that preventing spinal-induced hypotension is an important strategy to enhance maternal and neonatal outcomes in cesarean delivery Recent studies showed that 5-hydroxytryptamine-3 receptor antagonists, mostly used as nausea and vomiting prophylaxis agents, also contributed to inhibit the Bezold-Jarisch reflex and its associated hemodynamic consequences. Ondansetron is the most studied molecule in this field. Many recent studies and meta-analyses show renewed interest in the use of norepinephrine as a first line agent for preventing and treating spinal anesthesia-induced hypotension in obstetric anesthesia practice instead of phenylephrine. Norepinephrine has the advantage of a better cardiac output and cardiac frequency as compared to phenylephrine without any fetal side effect. The combination of ondansetron and phenylephrine for the prevention of spinal anesthesia-induced hypotension has been studied, but not the combination of ondansetron and norepinephrine. The main objective of this study is to evaluate the sparing effect of a standard dose of ondansetron on norepinephrine consumption during elective cesarean section under spinal anesthesia by determining the effective dose in 50% of subjects (ED50) of a prophylactic norepinephrine infusion after receiving a single dose of 4 mg of ondansetron or a saline control.

NCT ID: NCT04702932 Not yet recruiting - Multiple Myeloma Clinical Trials

Establishment of Genomic, Transcriptomic and Functional Characteristics of Tumor Cells in Hyperinflammatory Hemopathies

GEN-HEMO-INF
Start date: September 1, 2021
Phase:
Study type: Observational

Patients with monoclonal gammopathies either benign or malignant may develop inflammatory symptoms such as Schnitzler syndrome. We proposed to name those cases as monoclonal gammopathy of inflammatory significance, or MGIS. The aim of the study is to search for inflammatory pathway that may be activated in case MGIS and to search if the genetic of tumoral cell could explain those activations.

NCT ID: NCT04702399 Not yet recruiting - Clinical trials for Patients With an Indication for Myomectomy or Polymyomectomy

Hyaluronic Acid for the Prevention of Endocavitary Synechiae After Myomectomy

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

PREVENDO is a prospective, multicenter, pilot, and randomized study in 2 parallel arms and single blind, evaluating the proportion of endometrial synechiae 6 weeks after surgery in patients undergoing abdominal myomectomy or polymyomectomy, according to the application or not of an anti-adhesion gel (HYALOBARRIER® GEL ENDO)