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NCT ID: NCT03585218 Recruiting - Clinical trials for Breast Cancer Female

Women With Breast Cancer Undergoing Chemotherapy: Implications in Quality of Life

Start date: March 6, 2017
Phase: Phase 3
Study type: Interventional

Breast cancer (BC) triggers a myriad of physical and psychosocial stressors with repercussions on quality of life (QoL). The present study is a pioneering Randomized Controlled Trial (RCT) in Portugal, seeking to study the impact of a hedonic aroma during chemotherapy in women with breast cancer (3, 6 and 9 weeks, and 3 months upon concluding chemotherapy). To do this, the participants will be randomly assigned to one of the groups. The experimental group will be exposed to chemotherapy along with a hedonic scent, while the control group will only be exposed to chemotherapy. Both groups will be evaluated at the level of psychological morbidity, disease representation, coping, executive function, cortisol levels, severity of treatment effects and QoL.The aim of this study is to evaluate the impact of a hedonic aroma on the clinical, emotional and neurocognitive variables that contribute to reduce the side effects of chemotherapy and promote QoL in women with BC.

NCT ID: NCT03584685 Active, not recruiting - Clinical trials for Satisfaction, Personal

Impact of the Surgical Mask on the Patient-nurse Relation in Primary Care

Start date: January 31, 2018
Phase: N/A
Study type: Interventional

The goal of this study is to inspect the effect of nurses wearing the surgical mask on their patients' satisfaction with the relationship. All participants will initially be treated without the mask. Then, half will be treated with the mask and the other half will be treated without the mask.

NCT ID: NCT03583892 Not yet recruiting - Pain, Postoperative Clinical Trials

Use of Preoperative Gabapentin in Patients Undergoing Laparoscopic Cholecystectomy

Start date: July 2018
Phase:
Study type: Observational [Patient Registry]

The multimodal analgesia involves the administration of two or more analgesic agents that exert their effects via different analgesic mechanisms, providing superior analgesia with fewer side effects. This multimodal analgesic regimen includes opioids, nonsteroidal antiinflammatory drugs, cyclooxygenase-2 inhibitors, gabapentinoids, local anesthetics, and peripheral nerve blocks. The aim of this study is to evaluate postoperative analgesic benefit in patients administered with 600mg oral gabapentin as premedication for laparoscopic cholecystectomy under general anesthesia, with respect to postoperative pain scores and total postoperative requirements of morphine and/or tramadol.

NCT ID: NCT03578614 Recruiting - Clinical trials for Vascular Cognitive Impairment

Impact of Physical Activity in Vascular Cognitive Impairment ( AFIVASC )

AFIVASC
Start date: September 1, 2016
Phase: N/A
Study type: Interventional

Vascular cognitive impairment (VCI) is one of the most frequent causes of cognitive impairment associated with aging. So far, there is no approved treatment for VCI. Recent studies have suggested a protective effect from physical activity but adequate studies are lacking in this field. The AFIVASC study - a Portuguese acronym for "physical activity in vascular cognitive impairment" is a randomized controlled study, single-blinded, nonpharmacological which aims to explore the benefits of physical activity in vascular cognitive impairment (VCI)

NCT ID: NCT03575442 Recruiting - Schizophrenia Clinical Trials

"Art Therapy" in Acute Psychiatry

Start date: April 1, 2017
Phase: N/A
Study type: Interventional

Background: Given the complexity of this problem, psychiatric in-patients in the acute stage of their disease need different types of therapeutic programs to recover they mental health state. Usually they're submitted to systematic biological programs (namely psychopharmaceuticals), often considered a priority when compared to psychosocial programs. Among the different therapies that have been introduced in this context "art therapy", also named creative therapy, can constitute a treatment that complements the allopathic treatments, providing improvements in self-esteem and self-efficiency, distraction and relief from concerns and negative thoughts. Scientific evidence on the effects of psychosocial programs in the context of hospitalization of acute cases is scarce. Aims: a) evaluate the effectiveness of a 3 session program of "art therapy" in changing emotional indicators, namely depression, anxiety, stress, and psychological well-being, in individuals with mental illness; b) analyze the meanings a person attributes to his creative self-expression. Method: This is a pre-experimental, prospective study, with a pre test-post test design without control group, with a mixed approach (quantitative and qualitative). The study was performed in the psychiatry unit (Psiquiatria B), in the Centro Hospitalar e Universitário de Coimbra - Portugal. The target population was composed by men (older than 18), hospitalized in this ward. The exclusion criteria were: individuals with active psychotic symptomology, in manic phase and/or refusing to participate. The instruments used to collect information were: Depression, Anxiety and Stress Scale [DASS-21]; Ryff Scales of Psychological Well-Being (SPWB - 18 item version) and a semi-structured interview. Data collection and the development of this study occurred in the following manner: - Initial evaluation to verify the sample selection criteria in the first 48 hours after patient hospitalization; - Obtain informed consent for the application of instruments and participation in the "art therapy" intervention program; - Application of instruments (DASS-21 and SPWB-18 item version) before intervention; - Development of the program applied as a group, during three weeks, one session a week, each lasting approximately 90 minutes and assisted by a specialist in plastic expression. Each session was held in an occupational therapy room, including all the material deemed necessary for the execution of some of the techniques introduced by the technician. After each session, a semi-structured interview was conducted with each participant in order to analyze the meanings attributed. - In the end of the program, the same instruments were reapplied.

NCT ID: NCT03573336 Not yet recruiting - Endometriosis Clinical Trials

Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis

VILLENDO
Start date: June 29, 2018
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to assess the efficacy and safety of two doses of vilaprisan compared to placebo in women with symptomatic endometriosis. The secondary objective of this study is to evaluate the safety and tolerability of two different doses of vilaprisan in women with symptomatic endometriosis.

NCT ID: NCT03561116 Recruiting - Metabolic Syndrome Clinical Trials

Effects of Xanthohumol on Metabolic Syndrome Progression

XAN4Health
Start date: May 19, 2018
Phase: N/A
Study type: Interventional

A huge body of scientific evidence has suggested that xanthohumol (XAN) consumption, a polyphenol present in beer, has a positive effect on energy metabolism. This compound is known for its antioxidant, anti-inflammatory and anti-cancer properties which confer potential to be used as a food supplement. Nevertheless, XAN lipophilic properties prevent the extensive use of this molecule as a functional food compound. The company TA-XAN S.A.M. (Wiesbaden, Germany) has patented a method to overcome this solubility problem. So, the main aim of this study is to evaluate the effects of XAN consumption on metabolic syndrome progression in individuals recently diagnosed.

NCT ID: NCT03553420 Recruiting - Clinical trials for Lipodystrophy Congenital

Registry for Patients With Lipodystrophy

ECLip Registry
Start date: December 16, 2017
Phase:
Study type: Observational [Patient Registry]

Given the lack of knowledge on lipodystrophies, the medical and social responsibility for the persons affected by it calls for the monitoring of the progression over long periods of time. Sensible clinical and basic research into rare diseases such as lipodystrophy is only possible in multi-location networks with sufficient case numbers. Also, reliable information on the incidence of certain manifestation patterns, health status, etc. is of utmost importance for health care and health policy in this rare disease. Therefore, the European Consortium of Lipodystrophies (ECLip), an association of European experts on lipodystrophy, has launched a registry (OSSE) for lipodystrophies which is committed to help to improve the research conditions by consolidating this kind of information in a registry.

NCT ID: NCT03548987 Recruiting - Obesity Clinical Trials

Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

STEP 4
Start date: June 4, 2018
Phase: Phase 3
Study type: Interventional

This study will look at the change in participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what a participant can do to lose weight. The participant will get semaglutide for the first 20 weeks. Then the participant will get either semaglutide or "dummy" medicine - which treatment the participant gets after the 20 weeks is decided by chance. The participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years.

NCT ID: NCT03548545 Recruiting - Clinical trials for Major Depressive Disorder

tDCS as add-on Treatment to Cognitive-Behavior Therapy in People With MDD

ESAP
Start date: March 28, 2018
Phase: N/A
Study type: Interventional

This is a parallel randomized, double-blinded, sham-controlled clinical trial in which a total of 72 drug-naïve MDD subjects (36 per arm) are randomized to one of two groups: Cognitive-Behavior Therapy (CBT) combined with either active or sham tDCS. The primary outcome is mood improvement, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). The secondary outcome is to test whether tDCS combined with CBT can engage the proposed mechanistic target, of restoring the prefrontal imbalance and connectivity, by changes over EEG.