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Hypersensitivity clinical trials

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NCT ID: NCT06466200 Not yet recruiting - Quality of Life Clinical Trials

Validation of a French Version of the DHEQ

DHEQ-VALID
Start date: July 2024
Phase: N/A
Study type: Interventional

Dentin hypersensitivity (DH) results in brief, sharp pain in response to a stimulus. It often seems to be underdiagnosed but also undertreated due to the lack of consensus on the topic. DH has been shown to affects patients' quality of life. The Dentine Hypersensitivity Experience Questionnaire (DHEQ)is developed and validated : which is questionnaire assessing specifically the impact of DH on patient's quality of life. The DHEQ aims to help diagnose DH and assess the impact and subjective experience of the patient in order to better meet their expectations in terms of treatment. A French version, the DHEQ-fr, has been proposed (translation-counter-translation process and pilot study); however, it has not yet been validated (psychometric tests, test-retest). The main objective of the present study is to validate DHEQ-fr through a multicenter clinical study (three centers in France) in adult patients. The secondary objective is to compare the results of DHEQ-fr with those of the general oral health assessment index and oral health impact profil for the same patients. Patients are split between three DH groups (Schiff scores 1, 2 and 3) and a control group (non-DH). The overall sample size (all centers considered) for the DH group is 162 subjects divided into 54 subjects for each Schiff score (1 to 3; after cold air stimulation), with a control group of 54 subjects. A re-test will be performed, at 15 days, on a random sample of 60 subjects from the study population (in total: 15 non-DH subjects; 15 with a Schiff score of 1; 15 with a score of 2; 15 with a score of 3). The study of psychometric properties such as acceptability, internal consistency, reproducibility and internal structure validity will allow the validation of this French version of the DHEQ.

NCT ID: NCT06464939 Not yet recruiting - Clinical trials for Dentin Hypersensitivity

Phase 2 Study of KH001 in Long-term Relief From Dentin Hypersensitivity

Start date: August 19, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of KH001 in subjects with dentin hypersensitivity.

NCT ID: NCT06463457 Not yet recruiting - Prostate Cancer Clinical Trials

Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)

Start date: August 2024
Phase: Phase 2
Study type: Interventional

This research study is being done to determine the rate of testosterone recovery after completing two years of treatment with the combination of relugolix and darolutamide as well as to assess the safety of the drugs when administered in combination. The names of the drugs in this study are: - Relugolix (a type of gonadotropin-releasing hormone receptor antagonist) - Darolutamide (a type of androgen receptor antagonist)

NCT ID: NCT06456541 Not yet recruiting - Cow's Milk Allergy Clinical Trials

Infant Formula in Infants and Children With Cow's Milk Allergy

Start date: July 2024
Phase: N/A
Study type: Interventional

This is a multi-center, randomized, double-blinded, placebo-controlled food challenge to be conducted in infants and children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the experimental formula.

NCT ID: NCT06452212 Not yet recruiting - Clinical trials for Metastatic Hormone-Sensitive Prostate Cancer

Non-Interventional Study to Establish Consensus on Management of Metastatic Hormone-Sensitive Prostate Cancer Patients

Start date: July 31, 2024
Phase:
Study type: Observational

The purpose of this study is to establish an expert consensus recommendations on managing patients with mHSPC in South Korea, and to provide clinicians with a comprehensive guide to support their clinical decision making. There are no secondary objectives for this study.

NCT ID: NCT06448169 Not yet recruiting - Clinical trials for Triple Negative Breast Cancer

Observational Study on the Sensitivity of Neoadjuvant Immunotherapy in Early Triple-Negative Breast Cancer

Start date: May 30, 2024
Phase:
Study type: Observational

Studies have reported that tumors with the same immunogenic mutations may induce T cell receptor (TCR) domains with similar antigen recognition functions. By assembling the complementarity-determining region 3 (CDR3) of TCRs from RNA-seq data and correlating them with 9142 samples from TCGA data, an in-depth analysis of the TCR pool in the tumor microenvironment found a strong correlation between the CDR3 sequences of tumor-infiltrating T cells and tumor mutation burden. Fairfax et al. found that in patients responding to tumor immunotherapy, the TCR immune pool of CD8+ T cells produces many clones with extremely high abundance (exceeding 0.5%) . Cader et al. also found significant changes in the TCR immune pool of patients with Hodgkin's lymphoma responding to PD-1 tumor immunotherapy. Based on these theoretical foundations, evaluating the dynamic changes of the TCR immune pool is expected to be used to analyze the immune characteristics and changes in diseases such as malignant tumors.

NCT ID: NCT06446206 Not yet recruiting - Clinical trials for Platinum-sensitive Relapsed Ovarian Cancer

Adebrelimab Plus Chemotherapy, Bevacizumab and Fluzoparib in Platinum-Sensitive Relapsed Ovarian Cancer

Start date: June 2024
Phase: Phase 2
Study type: Interventional

The investigators explore the efficacy and safety of adebrelimab (PD-L1 inhibitor) plus chemotherapy and bevacizumab induction therapy followed by maintenance therapy with adebrelimab plus fluzoparib (PARP inhibitor)and bevacizumab in platinum-sensitive relapsed ovarian cancer.

NCT ID: NCT06429813 Not yet recruiting - Clinical trials for Metastatic Prostate Cancer

Remotely Monitored Exercise Interventions in Patients With mCSPC Undergoing ADT (Prostate 006)

Start date: July 2024
Phase: N/A
Study type: Interventional

This study consists of two home-based exercise programs: a stationary exercise bicycle intervention (Arm A), and a walking intervention (Arm B). The study will enroll 24 patients who are starting ADT (Androgen Deprivation Therapy)/ARSI (Androgen-Receptor Signaling Inhibitors) therapy for newly diagnosed metastatic castrate-sensitive prostate cancer (mCSPC). All participants will be asked to complete 1-2 training sessions at UVA prior to starting the exercise. All participants will be asked to complete aerobic and strength testing before and after the exercise program. Participants will be asked to answer questionnaires throughout the program. The at-home exercise will last for 12 weeks.

NCT ID: NCT06426108 Not yet recruiting - Clinical trials for Molar Incisor Hypomineralization

Interventions to Control Hypersensitivity Pain in Teeth With Insisive Molar Hypomineralization

LBIARHMI
Start date: July 1, 2024
Phase: Early Phase 1
Study type: Interventional

Molar incisor hypomineralization (MIH) manifests as a qualitative, demarcated defect in tooth enamel of systemic origin, predominantly affecting one or more permanent first molars, and potentially extending to the incisors. One significant challenge in managing this enamel anomaly is hypersensitivity, leading to discomfort and pain in affected patients. Low-intensity laser therapy, alone or combined with other modalities, appears promising in alleviating pain associated with MIH. This study aims to assess the efficacy of low-intensity laser therapy using varied parameters, in conjunction with a remineralizing agent, for pain management in children with molar incisor hypomineralization. Participants aged 6 to 12 years will be recruited, with a total of 88 teeth diagnosed with MIH, presenting a sensitivity score ≤3 on the Visual Analog Scale (VAS) and a score ≤1 on the Schiff Cold Air Sensitivity Scale (SCASS). The teeth will be randomly assigned to one of four groups (n=22 each): Group I (GI): L-1J + VF, Group II (GII): L-1J + VP, Group III (GIII): L-2J + VF, and Group IV (GIV): L-2J + VP. Here, 'L' denotes low-intensity laser application at different parameters (1J and 2J), combined with either fluoride varnish (VF) or a placebo varnish (VP). Interventions and assessments will be conducted initially, after 48 hours, and at 1 and 2 weeks post-treatment. Patients will undergo re-evaluation at 2, 4, 8, and 12 weeks following interventions. Statistical analyses will be performed with a 95% confidence level (α = 0.05).

NCT ID: NCT06417580 Not yet recruiting - Dentin Sensitivity Clinical Trials

Effect of Pregabalin Gel in Controlling Cervical Dentin Hypersensitivity

Start date: May 28, 2024
Phase: Phase 2
Study type: Interventional

This randomized, double-blind, placebo-controlled clinical study aims to evaluate the effect of a gel formulation based on 10% of pregabalin in the treatment of HD and on the participants' quality of life. The sample calculation will be based on previous work. After selecting participants, the participants will be randomly assigned to the following groups: placebo control group (CG), potassium nitrate gel group (GNK) and pregabalin gel group (GPG). A questionnaire (QEDH-15) to assess the impact of desensitizing treatment on oral health-related quality of life (OHRQoL) will be applied at baseline (T0) and in the last sensitivity record (T6). Pain will be assessed using a visual analogue scale after evaporative stimulation with an air jet and tactile stimulation with an exploratory probe. Three desensitizing treatment sessions will be carried out, with an interval of 72 hours between them. Sensitivity recording will be performed at T0 (baseline), T1 (after the first session), T2 (after the second session), T3 (after the third session), T4 (7 days after the last session), T5 (one month after the last session) and T6 (3 months after the last session). Data will be collected and subjected to statistical analysis for parametric data (ANOVA followed by Student-Newman-Keuls) or non-parametric data (Friedman's ANOVA followed by Tukey). To analyze the impact on quality of life, the Friedman test will be used.