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NCT ID: NCT05321355 Recruiting - Insomnia Clinical Trials

Mainz Register of Patients With Sleep Disorders

MAINZ-SLEEPREG
Start date: February 1, 2022
Phase:
Study type: Observational [Patient Registry]

Prospective longitudinal observational registry study of all patients with sleep disorders treated in the Mainz Comprehensive Epilepsy and Sleep Medicine Center with the focus on the course of the disease and quality of life.

NCT ID: NCT05314920 Recruiting - Emotional Disorder Clinical Trials

Cost-effectiveness of a Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care

PsicAP-Costs2
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to test the cost-effectiveness and cost-utility of adding a transdiagnostic group cognitive-behavioural therapy (TD-CBT) to treatment as usual (TAU) for emotional disorders in primary care . A single-blind randomized controlled clinical trial will be conducted to compare the TD-CBT group therapy plus TAU to progressive muscle relaxation (PMR) group plus TAU in individuals, aged 18 to 65, with emotional disorders in four primary care centres located in Cantabria, Spain. The study will take a societal perspective. Psychological assessments will be carried out at baseline, post-treatment, and 12-months follow-up. The assessments will include measures of clinical symptoms (anxiety, depression, and/or somatic), dysfunction, cognitive-emotional factors (ruminative processes, pathological concern, attentional and interpretative biases, emotion regulation strategies and meta-cognitive beliefs), and satisfaction with the treatment received. Data on health service use, including medication and days of absence from work, will be collected from electronic medical records. The primary outcomes are the incremental cost-effectiveness ratios (ICER) based on the difference in mean costs and effectiveness between interventions and incremental cost-utility ratios (ICURs) based on health-related quality of life at post-treatment and 12-month follow-up. Secondary outcome measures include clinical symptoms, quality of life, functioning and treatment satisfaction. Bootstrap sampling will be used to assess the uncertainty of the results. Secondary moderation and mediation analyses will also be conducted. In addition, in sessions' number 1, 4 and 7 of both treatment arms, two questionnaires will be administered that collect therapeutic alliance and group satisfaction. The main study hypothesis is that adding TD-CBT to TAU in primary care will be more cost-effective than TAU plus PMR. In addition, these gains will be maintained in the 12-month follow-up. If it is successful, the dissemination of cost-effective treatment can help to overcome problems in accessing psychological treatment for emotional disorders in the context of an increasing demand for mental healthcare in primary care.

NCT ID: NCT05312190 Recruiting - Menstrual Disorders Clinical Trials

Clinical and Basic Researches Related to ZhenQi Buxue Oral Liquid in Treating Menstrual Disorders

Start date: March 15, 2022
Phase: N/A
Study type: Interventional

This study is a national multicenter prospective, randomized, controlled trial, which evaluates Zhenqi Buxue Oral Liquid,Progesterone Capsules and the addition of Zhenqi Buxue Oral Liquid to Progesterone Capsules in the treatment of menstrual disorders in adults women. One third of participanta will receive Zhenqi Buxue Oral Liquid, one third of participanta will receive Progesterone Capsules, and the another third will receive Zhenqi Buxue Oral Liquid and Progesterone Capsules in combination.

NCT ID: NCT05307848 Recruiting - Bipolar Disorder Clinical Trials

Reproductive Function in Women With Bipolar Disorder

Start date: March 1, 2021
Phase:
Study type: Observational [Patient Registry]

Many studies have shown that patients with bipolar disorder are prone to reproductive dysfunction, including polycystic ovary syndrome, hyperprolactinemia, and amenorrhea. However, there is still considerable disagreement about the causes of reproductive dysfunction in patients with bipolar disorder. This study will evaluate the reproductive function of female patients with bipolar disorder without medication and those with bipolar disorder after stable medication, compared with the health control. The purpose of the study is to explore the influence, degree, and possible risk factors of bipolar disorder itself and drugs on the reproductive function of female patients.

NCT ID: NCT05305833 Recruiting - Clinical trials for Temporomandibular Disorder

Stem Cells and Stromal Vascular Fraction for Temporomandibular Joint Disease

Start date: October 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

It will be evaluate the safety of mesenchymal stem cells and adipose tissue derived stromal vascular fraction (SVF) in temporomandibular joint disease cases.

NCT ID: NCT05297929 Recruiting - Bioequivalence Clinical Trials

A Bioequivalence Trial of Irbesartan Tablets(0.15g) in Healthy Chinese Subjects

Start date: February 17, 2022
Phase: Phase 1
Study type: Interventional

To study the pharmacokinetics of test preparation and reference preparation irbesartan tablets (0.15g/tablet) in a single oral administration in fasting and fed state,respectively, in healthy adult subjects, and to evaluate the bioequivalence of the two preparations

NCT ID: NCT05296915 Recruiting - Bulimia Nervosa Clinical Trials

Bulimia Nervosa and Binge Eating Disorder: Comparing Therapeutic Strategies

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

This study aims to assess the effectiveness of new neurostimulation techniques in patients with eating disorders. The primary aim of our proposal is to test a reduction in symptoms of alteration of eating behaviors, such as always thinking about food or binge eating, in a sample of 30 patients, aged between 18 and 65, with diagnosis of Bulimia Nervosa or Binge Eating Disorder. Of these patients, 10 will undergo to a protocol of vagal transcutaneous stimulation in the ear (tVNS) and targeted cognitive-behavioral therapy (CBT-E), another 10 to a protocol of transcranial magnetic stimulation (rtms) and CBT-E and another 10 to a protocol of only tergeted CBT-E, comparing the results obtained in the three groups under study. Secondary purposes of this project are the assessment of the effects of auricular vagal transcutaneous stimulation and of transcranial magnetic stimulation on depressive symptoms associated with eating disorder, on the inflammatory profile, on cardiovascular autonomic control, neuronal excitability, functional connectivity and on the quality of life of these patients. In order to achieve the objectives of this research project, we will perform a national, interventional on a medical device, monocentric study, controlled in 3 parallel and randomized groups with a 1:1:1 allocation ratio. 30 patients will be recruited at the Day Hospital of the Psychiatry Unit of the Fondazione.

NCT ID: NCT05286645 Recruiting - Depressive Disorder Clinical Trials

Intervention Effect of High Definition Transcranial Direct Current Stimulation (HD-tDCS) on Depressive Disorder

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

To investigate the intervention effect of high definition transcranial direct current stimulation (HD-tDCS) on suicidal ideation and somatic symptoms in patients with depressive disorder and its underlying neural mechanism by MRI.

NCT ID: NCT05280015 Recruiting - Depression Clinical Trials

Microbiotherapy in Characterized Depressive Disorder

PROMOOD
Start date: June 8, 2022
Phase: Phase 2
Study type: Interventional

The study aims to evaluate the contribution of a multi-targeted microbiotherapy at 12 weeks in depressed-patients in a situation of failure of a 1st line of antidepressant treatment and treated in add-on with a 2nd antidepressant, venlafaxine.

NCT ID: NCT05276193 Recruiting - Gambling Disorder Clinical Trials

GamReg Sweden - Quality Register for Gambling and Gaming Disorders

Start date: April 15, 2019
Phase:
Study type: Observational [Patient Registry]

This is a quality register for the monitoring of clinical assessment and treatment for gambling disorder and gaming disorder in Swedish health care. This register is held by Region Skåne, the health care organization of Skåne in southern Sweden, and administered by Register center South, which is associated with health care services in the southern regions of Sweden (the establishment of quality registers in Swedish health care relies upon a national legislation). Quality registers by themselves do not represent formal research projects. However, future research projects can use quality registers, such as the present one, as a data source for future research projects in case they are approved by an ethics authority. Clinical study variables collected in the register include the following (examples): - gender, age, occupation, living conditions - if applicable, types of gambling associated with the treatment needs - if applicable, type of problematic video gaming - type of referral to the present treatment contact - treatment history in psychiatry, social services, enforcement agency - history of suicidal behavior - alcohol and drugs problems requiring assessment or treatment - violence victimization - type of treatment provided to the patient