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NCT ID: NCT05804864 Not yet recruiting - Clinical trials for Advanced Solid Tumors

A Study of KM501 in Patients With Solid Tumors

Start date: April 2023
Phase: Phase 1
Study type: Interventional

A single-arm, open, multicenter Phase I study to evaluate the safety, tolerability, pharmacokinetic profile, and efficacy of the KM501 double-antibody ADC in subjects with advanced solid tumors that express, amplify, or mutate HER2

NCT ID: NCT05804877 Not yet recruiting - Clinical trials for Depression in Adolescence

Online MBCT Program for University Students

Start date: April 2023
Phase: N/A
Study type: Interventional

The goal of this interventional study is to examine the efficacy of the online mindfulness-based cognitive therapy program(MBCT) in youth (18-25 years old) with depressive symptoms. The main questions it aims to answer are: - Whether the program could reduce depressive symptoms in university students. - Whether the program could increase quality of life in university students. - The effectiveness, acceptance, and practicability of the program for university students. Participants in the experimental group would be arranged to attend online mindfulness-based cognitive programs for eight weeks. The control group would be educated the knowledge of mental health to manage their negative emotions.

NCT ID: NCT05805787 Not yet recruiting - Constipation Clinical Trials

Acupressure for Constipation in the Elderly

Start date: April 2023
Phase: N/A
Study type: Interventional

This study will carried out to determine the effect of acupressure applied to Tianshu (ST25), Guanyuan (CV4) and Hegu (LI4) acupuncture points for a total of 6 minutes, two to each point, on the symptoms of constipation in the elderly people receiving institutional care.

NCT ID: NCT05806073 Not yet recruiting - Clinical trials for Oral Squamous Cell Carcinoma

Elective vs Therapeutic Neck Dissection in Treatment of Patients With Clinical T1/2N1M0 Oral Squamous Cell Carcinoma

Start date: April 2023
Phase: N/A
Study type: Interventional

Cervical lymph node metastasis is the most important prognostic factor of oral squamous cell carcinoma (OSCC). Therapeutic neck dissection (I-V region) has always been regarded as the standard scheme of neck surgery for patients with cN+ OSCC and however, it has brought obvious side effects, which seriously affects the postoperative quality of life of patients. In addition, excessive neck lymph node dissection will also affect the local immune function of patients to some extent and reduce the body's response to immunotherapy. Lymph node metastasis of primary oral squamous cell carcinoma follows certain rules. Most of the metastatic areas are I-II, and low-level metastasis is very rare. Therefore, more than 90% of patients with cN+ oral squamous cell carcinoma who have undergone Therapeutic neck dissection may have suffered from "excessive dissection of area of IV and V". Both the long-term clinical experience of surgeons and a large number of recent retrospective studies show that elective neck dissection (I-III region) is safe enough for patients with oral squamous cell carcinoma of cN1 and part of cN2.There is clearly a need therefore for a large randomized trial that will resolve the issue either way once and for all.

NCT ID: NCT05808075 Not yet recruiting - Clinical trials for Clinical Performance

Clinical Performance of Nano Fiber Reinforced Versus Conventional Nano Hybrid Composite in Restoring Premolars

Start date: April 2023
Phase: N/A
Study type: Interventional

In patients that need composite restorations in a compound proximal carious lesions in premolars, will the clinical performance of nano fiber reinforced resin composite restorations have similar results compared to those restored with conventional nano hybrid resin composite over two years follow up period?

NCT ID: NCT05808244 Not yet recruiting - Schizophrenia Clinical Trials

Tele-group Cognitive Behavioural Family Intervention (tgCBFI) for People With Schizophrenia and Their Families

Start date: April 2023
Phase: N/A
Study type: Interventional

This mixed-method study aims to examine the feasibility of delivering tgCBFI programme to dyads of people with schizophrenia and their family caregivers, and generate preliminary evidence on the effectiveness of tgCBFI in reducing expressed emotion. The research questions are as follows. 1. What are the feasibility, acceptability, and safety of conducting a tele-group CBFI programme for people with schizophrenia and their family caregivers? 2. What effect does tgCBFI have on the expressed emotion experienced by adults with schizophrenia and the caregiving experience of their family caregivers at posttreatment and 12-week after completion of the programme? 3. What effect does tgCBFI have on the positive and negative symptoms of adults with schizophrenia and the perceived care burden and level of mood disturbance of their family caregivers at posttreatment, and 12-week after completion of the programme?

NCT ID: NCT05808543 Not yet recruiting - Hearing Loss Clinical Trials

BEARS Training Package to Maximise Hearing Abilities in Older Children and Teenagers With Bilateral Cochlear Implants

BEARS
Start date: April 2023
Phase: N/A
Study type: Interventional

The goal of the BEARS clinical trial is to determine whether using the directional listening training delivered via the BEARS training package for 3-months alongside usual care compared to only receiving usual care improves speech-in-noise perception, hearing experiences, vocabulary and quality of life and reduces listening effort in young people between 8-16 years old (inclusive) with two cochlear implants. The participants will complete hearing assessments and questionnaires before completing the 3-month intervention. They will be followed up for the next 9-months through online and in-person appointments.

NCT ID: NCT05809050 Not yet recruiting - Acute Leukemia Clinical Trials

Study of miRNA-155 in Acute Leukemia

Start date: April 2023
Phase:
Study type: Observational

The leukaemias are a heterogeneous group of blood cancers, Acute leukaemia (AL) is caused by malignant proliferation of blood cells arrested at an immature stage of development, They are very aggressive diseases that run a rapidly fatal course if not promptly diagnosed and appropriately treated. Misdiagnosis is very common with delay in diagnosis and prompt treatment being the causes of high morbidity and mortality in acute leukaemias. Although with the continuous improvement of clinical and laboratory diagnosis and treatment methods, the prognosis of AML has been significantly improved, but there are still about 70% of patients who cannot survive more than 5 years after diagnosis The activity of miRNAs in tumors is regulated by the same alterations affecting protein-coding genes, such as chromosomal rearrangements, genomic amplifications or deletions or mutations, abnormal transcriptional control, dysregulation of epigenetic changes and defects in the biogenesis machinery A typical chromosomal rearrangement is a chromosomal translocation, especially in hematological malignancies, in which it promotes tumor development and progression by the promoter exchange or by the creation of chimeric genes translated as fusion proteins. In Acute Myeloid Leukemia (AML) patients with myeloid/lymphoid leukemia gene (or mixed-lineage leukemia, MLL) rearrangement, by large-scale genome-wide microarray analysis, it was demonstrated that among 48 selected miRNAs, 47 of them are increased

NCT ID: NCT05810610 Not yet recruiting - Coronary Stenosis Clinical Trials

Automatic Anatomical and Functional Classification of Coronary Arteries With Artificial Intelligence.

COROSCAN-IA
Start date: April 2023
Phase:
Study type: Observational

The goal of this Category 3 research involving the human person is to predict the measurement of the post-stenosis flow (FFR) using CTTA coupled with an intelligent predictive analysis system and comparing it with invasive coronary angiography FFR as measurement of reference. The population studied are adult patients,- with no diagnosed coronary status or history of stenting or bypass surgery- with indication for FFR measurement. The main question it aims to answer is: • Can, in a single acquisition, CTTA coupled with AI produce good predictive performance of stenosis and FFR ? If it can it will allow us to avoid the need for invasive FFR. For patients who will be included in the retrospective part: only their data from their medical records will be used. Patients who will be included in the prospective part will additionally complete the EQ5D5L questionnaire before coronary angiography and at the end of the patient's participation (4 months after the CCTA). There is a no comparison group, the predictive FFR from CTTA of a patient will be compared with angiography FFR from the same patient, same vessel.

NCT ID: NCT05811507 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

Evaluation of Serum Adrenal Androgens Among Prepubertal and Pubertal Boys With Autism Spectrum Disorder

Start date: April 2023
Phase:
Study type: Observational

Autism spectrum disorder (ASD) is a neurodevelopmental disorder of unclear etiology. There are theories depicting the importance of sex steroid hormones in autism, since the prevalence of the disorder is male-biased. What makes boys more vulnerable to achieve the diagnosis of autism remains unclear. One of the theories strengthens the importance of fetal organizational effect of testosterone on brain development. Baron Cohen with coworkers showed that elevated fetal levels of several androgens including testosterone were high in male-fetuses who later in postnatal life achieved the diagnosis of autism and fetal testosterone levels were positively correlated with autistic traits in general population. Females with conditions of abnormal prenatal exposure to testosterone and its sex steroid precursors, such as congenital adrenal hyperplasia and polycystic ovary syndrome, were found to have higher rate of autistic traits as well as their children were of higher risk of developing autism. However, the exact mechanism by which these hormones influence the manifestation of autistic traits remains undiscovered. Another model explaining higher prevalence of ASD in males is a female protective model which suggests that multiple genetic factors contribute to the development of ASD and that higher threshold of genetic liability is required in females compared to males. Zhang et al. demonstrated genetic evidence of sex differences in ASD confirming female protective model, employing investigation of de novo mutations, common variants of ASD candidate genes and their co-expression in male and female brain. During infancy: The Gonadotropin releasing hormone (GnRH) pulse generator is reactivated by 6 to 10 days after birth. This period, termed the mini puberty of infancy, was first described in the 1970s. During mini puberty, luteinizing hormone (LH) levels approximate pubertal concentrations, reaching a peak between 16 and 20 days of life. Serum testosterone levels rise in response to rising concentrations of LH, paralleling an increase in Leydig cell number and testicular testosterone concentrations. Serum testosterone levels peak from 1 to 3 months (210 ± 130 ng/dL or 7.28 ± 4.51 nmol/L on day of life 30) and decline by roughly 50% per month reaching prepubertal levels by 7 to 12 months of age. Dihydrotestosterone (DHT) concentrations parallel the rise in testosterone, reaching pubertal values during the early postnatal period. During puberty: Testosterone is produced primarily by the testes, though a small amount is also made in the adrenal gland. Gonadarche refers to the onset of sex steroid production from the gonads and occurs in response to pulsatile production of GnRH from the hypothalamus, which in turn stimulates production of LH and Follicle stimulating hormone (FSH) from the pituitary gland. LH stimulates the Leydig cells to produce testosterone, whereas FSH stimulates the Sertoli cells to proliferate and initiate spermatogenesis. Active androgens are synthesized via two alternative pathways. The first of them is known as the classic "frontdoor" pathway with pregnenolone serving as androgen precursor, which underwent a conversion to DHEA and subsequently to androstenediol. These metabolic steps are catalyzed by CYP17A1 (in the C17,20-lyase step) and (mostly adrenal) AKR1C3 enzyme, respectively. Dehydroepiandrosterone (DHEA) and androstenediol are readily sulfated by SULT2A1 in adrenal cortex and their sulfates serve as the stock pool for the production of active androgens of the adrenal origin as the production of androgens in early childhood of boys is limited to extra-gonadal tissues, such as adrenal, skin, etc. These sulfated primary androgens may be subsequently deconjugated and metabolized by HSD3B1 and HSD3B2 isoforms to androstenedione and Total testosterone (TST) and then to 5α/β-reduced 17-oxo- and 17β-androgens, respectively. In addition, the androstenedione may be readily converted to testosterone by adrenal AKR1C3. From the aforementioned substances, TST, 5α-dihydrotestosterone, and 11-oxo-testosterone are known as the most potent bioactive androgens. Besides the "frontdoor" pathway the dihydrotestosterone may be also formed by so called "backdoor" pathway. This pathway is based on a direct conversion of 5α/β-reduced pregnane steroids (C21) to their 5α/β-reduced androgen (C19) metabolites which is catalyzed by the same enzyme converting pregnenolone to DHEA (CYP17A1 in the C17,20-lyase step). These 5α/β-reduced androgen (C19) metabolites include also the most active androgen 5α-dihydrotestosterone. The "backdoor" pathway is crucial for androgen synthesis in marsupials but may also be active in various human steroid-related disorders.