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Adverse Drug Event clinical trials

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NCT ID: NCT06244706 Not yet recruiting - Chronic Pain Clinical Trials

QSPainRelief-STRAT

QSPR-STRAT
Start date: February 1, 2024
Phase: N/A
Study type: Interventional

Investigating the clinical outcomes of drug combinations (opioid + medication acting on the central nervous system) in patients suffering from persistent pain (pain lasting for at least three months) through patient-reported outcomes.

NCT ID: NCT06152471 Recruiting - Diarrhea Clinical Trials

Effect of Salovum™ and SPC-Flakes™ on Abemaciclib-induced Gastrointestinal Toxicity in Early Breast Cancer

ASF-BC
Start date: June 7, 2023
Phase: Phase 3
Study type: Interventional

The present study aims to investigate a proactive strategy including Salovum™ and SPC-flakes to prevent the occurrence of abemaciclib-induced diarrhea in patients with early breast cancer.

NCT ID: NCT06120712 Recruiting - Melanoma Clinical Trials

A Phase Ⅰb Study on Autologous GC101 TIL Injection for the Treatment of Advanced Melanoma (MIZAR-002)

MIZAR-002
Start date: November 8, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

20 participants are expected to be enrolled for the Phase Ib clinical trial,this trail is expected to be finished in 20 months.

NCT ID: NCT05800054 Recruiting - Clinical trials for Esophageal Neoplasms

Effect of NST Whole-course Nutritional Management on Nutritional Status and Adverse Reactions in Esophageal Cancer

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

This study is a randomized, open, parallel controlled clinical trial. The main purpose of this study was to compare the changes in body weight/body mass index (BMI) before and after treatment between the two groups of patients with NST full-course nutritional management and without NST full-course nutritional management. The secondary objective was to compare the quality of life, nutritional status, immune function and inflammatory response, adverse reactions of radiotherapy and chemotherapy, and short-term/long-term efficacy between the two groups. The treatment plan was: esophageal cancer with routine nutrition guidance as the control group, and the NST whole-process intervention guidance as the experimental group. 1. Experimental group: NST whole-course intervention 1. Nutritionists formulate nutritional programs and manage them in a refined manner. On the basis of the patient's natural diet (food and homogenate meal), enteral nutritional preparations or parenteral nutritional supplements are given according to the patient's gastrointestinal obstruction, dietary structure, and food intake. Energy 30-35kcal/kg/d, protein 1.2-1.5g/kg/d. Enteral nutrition administration route: oral or tube feeding or ostomy, oral feeding is preferred; severe obstruction of eating or oral can not meet the target nutrition, choose tube feeding or ostomy. When it is expected that enteral nutrition cannot meet 60% of the target energy requirement for 3 to 5 days, choose parenteral nutrition. The enteral nutritional preparation adopts the whole protein enteral nutritional preparation Nengquan, and/or the tumor nutritional preparation Ruineng, and/or whey protein powder. 2. Radiotherapy 3. Chemotherapy 2. Control group: routine nutrition guidance for esophageal cancer (1) Nutritional therapy: The nutritional program was the same as that of the experimental group, and the patients performed it themselves. (2) Concurrent chemoradiotherapy: the same as the experimental group. Efficacy evaluation: 1. Body weight and body mass index (BMI) 2. Quality of life score (EORTCQLQ-C30) 3. Nutritional status 4. Immune function and inflammatory response (total lymphocytes, CRP, IL-6) (4) Intestinal mucosal barrier and intestinal flora (5) Adverse reactions of radiotherapy and chemotherapy (6) Short-term/long-term efficacy (5) Evaluation of treatment side effects (6) Short-term/long-term efficacy

NCT ID: NCT05799053 Recruiting - Clinical trials for Irritable Bowel Syndrome

Peppermint Oil for the Treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children: the MINT Study

MINT
Start date: May 12, 2022
Phase: Phase 3
Study type: Interventional

Peppermint oil has shown to be effective in the treatment of Irritable Bowel Syndrome (IBS) symptoms in adults. Few studies of low quality are performed in an paediatric setting. Therefore, the investigators will conduct a multicenter randomized, placebo controlled trial to investigate the effects of an eight-week peppermint oil treatment in paediatric IBS or Functional Abdominal Pain - Not otherwise specified (FAP-NOS) patients.

NCT ID: NCT05798104 Withdrawn - Clinical trials for Medication Adherence

Collaborative Nurse-pharmacist Counseling for Self-administered Biologics

COLLAB
Start date: March 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn if nurse-pharmacist counseling can improve patient knowledge and confidence and prevent side effects in patients who start a biologic medication in-office and later continue the medication at home. The main question it aims to answer are: • Does nurse-pharmacist counseling improve patient-reported knowledge and confidence in biologic self-treatment when moving from in-office to at-home administration? Participants will attend a brief counseling session in office and respond to a pre-counseling and post-counseling survey to look at medication knowledge and confidence. Participants will be contacted at three months after the survey to ask if they had any side effects related to their biologic medicine. Data will be collected from the participant's medical record at the study institution for up to six months after the study counseling session.

NCT ID: NCT05717712 Recruiting - Clinical trials for Diffuse Intrinsic Pontine Glioma

Oncolytic Virus Ad-TD-nsIL12 for Primary Pediatric Diffuse Intrinsic Pontine Glioma

Start date: January 4, 2023
Phase: Phase 1
Study type: Interventional

This is a drug safety assessment clinical trial with a 3+3 dose escalation design, to observe the safety, tolerability and toxicity of a novel oncolytic virus Ad-TD-nsIL12 intratumoral injection in primary DIPG patients (NCI-CTCAE V5.0).

NCT ID: NCT05717699 Recruiting - Clinical trials for Diffuse Intrinsic Pontine Glioma

Oncolytic Virus Ad-TD-nsIL12 for Progressive Pediatric Diffuse Intrinsic Pontine Glioma

Start date: January 4, 2023
Phase: Phase 1
Study type: Interventional

This is a single-arm, single-center, drug safety assessment clinical trial with a 3+3 dose escalation design, to observe the safety, tolerability and toxicity of a novel oncolytic virus Ad-TD-nsIL12 intratumoral injection in progressive DIPG patients (NCI-CTCAE V5.0).

NCT ID: NCT05538065 Active, not recruiting - Aging Clinical Trials

NUDGE-EHR Replication Trial at Mass General Brigham

NUDGE-EHR
Start date: November 10, 2022
Phase: N/A
Study type: Interventional

Prescribing of potentially unsafe medications for older adults is extremely common; benzodiazepines and sedative hypnotics are, for example, key drug classes frequently implicated in adverse health consequences for vulnerable older adults, such as confusion or sedation, leading to hospitalizations, falls, and fractures. Fortunately, most of these consequences are preventable. Physicians' lack of awareness of alternatives, ambiguous practice guidelines, and perceived pressure from patients or caregivers are among the reasons why these drugs are used more than might be optimal. Reducing inappropriate use of these drugs may be achieved through decision support tools for providers that are embedded in electronic health record (EHR) systems. While EHR strategies are widely used to support the informational needs of providers, these tools have demonstrated only modest effectiveness at improving prescribing. The effectiveness of these tools could be enhanced by leveraging principles of behavioral economics and related sciences.

NCT ID: NCT05512169 Recruiting - Pediatric Cancer Clinical Trials

Pharmacogenomic Association Study in Indian Children With Acute Lymphoblastic Leukemia

MPGx-INDALL
Start date: December 1, 2022
Phase:
Study type: Observational

A five-year prospective observational cohort study. The study is focused on observing the relation between static germline variants and therapeutic response in Indian children with acute lymphoblastic leukemia (ALL). The project is an International multicenter setup. This collaborative research project between Switzerland and India includes one main center in Geneva that has conceptualized, designed, received grants for the study and two investigating centers in India (Puducherry and New-Delhi) involved in study design, patient care and recruitment for this specific study. All the participants for the study will be recruited form these two centers in India, and no patient recruitment is planned at main center i.e. Geneva. The study will be conducted in two phases. The first aims to investigate genetic predisposition (static germline variants) to early chemotherapy treatment related toxicities (TRTs). The second aims to investigate somatic genetic markers associated with the efficacy of steroid treatment among patients undergoing the standardized IciCLe-ALL-14 treatment protocol. A total of 500 children with ALL will be recruited to investigate primary objective of the study i.e. TRT, and a subset of 250 patients will be included to investigate another research question i.e. response to steroid therapy.