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NCT ID: NCT03400709 Completed - Clinical trials for Cisplatin Adverse Reaction

Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer

Start date: November 2015
Phase: N/A
Study type: Interventional

Introduction. Cisplatin-induced ototoxicity is a very frequent event and its consequences can cause a lot of deterioration in patients. Early diagnosis is essential because it would allow the appropriate implementation of strategies to reduce its effect. Among these N-acetylcysteine, an antioxidant agent that has shown otoprotective effect. Study design. Randomized, parallel design and placebo controlled clinical trial. Methods. Patients with head and neck cancer who require treatment with cisplatin were enrolled in 2 branches: a control group that receives a placebo and experimental group that receives the drug. High-frequency audiometries (6 - 16 KHz) are performed before, during and after the treatment finalization.

NCT ID: NCT03389945 Not yet recruiting - Labor Pain Clinical Trials

Different Spinal Needles Sizes and Dural Puncture Epidural For Labor Analgesia

Start date: January 4, 2018
Phase: N/A
Study type: Interventional

The rationale behind the dural puncture epidural (DPE) technique lies in the fact that a dural perforation with a spinal needle purportedly creates a conduit for accelerated translocation of local anesthetics from the epidural to the subarachnoid space. When compared with conventional epidural block, it provides improved sacral block and onset of analgesia. Despite the benefits associated, the supportive literature remains scarce. No trial has determined if similar results could be obtained with a smaller needle. In this trial, DPE using 25- and 27-gauge (G) spinal needles are compared. The main outcome will be the time required to obtain a pain score ≤ 1 using a 0-10 numeric rating scale (NRS). The hypothesis is that that both needle sizes will result in similar onset times and therefore designing the current study as an equivalence trial.

NCT ID: NCT03383172 Active, not recruiting - Mental Health Clinical Trials

Mental Health Prevention Among Preschool Children Using a Culturally Adapted Version of ICPS

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

Mental health in Chilean children and families is an urgent public health problem. Prevalence of psychiatric disorders among children between 4 and 11 years old is 27.8%, a higher percentage than was found in adolescents between 12 and 18 years old, which is 16.5%. The most frequent disorders in the population between 4 and 11 years old were disruptive disorders (20.6%), followed by anxiety disorders (9.2%). Mental health problems generate a high burden of disease on society in general; and there is an important treatment gap, especially among economically vulnerable populations. Prevention strategies appear to be the more recommendable options, mainly if these interventions can be implemented early in life and at low cost. Few preventive interventions aiming to increase resilience in the face of adversity, have been rigorously evaluated in Chile among preschoolers. There is substantial international evidence that shows that strengthening basic psychological skills, such as emotion regulation and social problem-solving, can reduce the incidence of mental pathology and improve various academic indicators. The curriculum of the Interpersonal Cognitive Problem Solving Program, also known as I Can Problem Solve (ICPS), is focused on the development of the cognitive process and children's social problem-solving skills. ICPS has been found to be effective in increasing pro-social behaviours and reducing aggressive behaviour among preschoolers. No previous studies in Spanish-speaking Latin American countries have been conducted aiming to explore the acceptability and feasibility of ICPS to provide information to evaluate later the effectiveness of this intervention at a larger scale. The main objective of this study is the evaluation of the acceptability and feasibility of an adapted version of ICPS in the national context at educational institutions with high socio-economic vulnerability, with the ultimate goal of increasing social-emotional competence and reducing emotional and behavioural problems in preschoolers.

NCT ID: NCT03374904 Recruiting - Parenting Clinical Trials

Video Feedback to Enhance Parental Mentalization

Start date: August 2, 2017
Phase: N/A
Study type: Interventional

The objective of this study is to implement a Video Feedback (VF) intervention to enhance Parental Reflective Function in primary caregivers of inpatient psychiatric children. Because there is no published research using VF with parents of children with severe psychopathology and in hospitalized context, this study is a pilot study. The research will include a qualitative and quantitative study; it will take place in a public hospital in Valparaíso, Chile. In the qualitative study, participants will be six primary caregivers who received the intervention and three stakeholders from Child Unit. For caregivers a semi-structured interview will be applied to know subjective experience gained by intervention regarding the perceived satisfaction. For health professional also a semi-structured interview will be applied to collect information pertinent to the feasibility of performing such intervention. The information obtained from the interviews will be analyzed with Grounded Theory model. The quantitative study will be conducted amongst all tutors of children aged between 6 and 14 hospitalized in a child psychiatry ward between August 2017 and December 2018. The expected sample size is 30 subjects in total; 10 for the control group and 20 for the experimental group. A four module of Video Intervention Therapy (VIT) was designed, each module includes a (video recorded) play session and a group VF session. The evaluation of the caregivers at the beginning of the intervention will include a psychosocial questionnaire, GHQ-12 , Five Minutes Speech Sample (FMSS) where RF will be codified, Operationalized Psychodynamic Diagnosis - Structure Questionnaire (OPD.SQ). The Strengths and Difficulties Questionnaire will be applied to children, in addition to the Children Global Assessment Scale, (CGAS). After every VF session a new FMSS, GHQ-12 and CGAS will be made. A follow-up will be performed three months after the beginning of the intervention with FMSS, GHQ-12 for caregivers and SDQ and CGAS for children. To determine Effect Size and Intra Class Correlation, the results will be analyzed using a multiple linear regression.

NCT ID: NCT03345836 Recruiting - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

Start date: November 29, 2017
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in subjects with moderately and severely active Crohn's disease (CD).

NCT ID: NCT03338790 Not yet recruiting - Prostate Cancer Clinical Trials

An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer

CheckMate 9KD
Start date: November 30, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine which combination of Nivolumab plus either Rucaparib, Docetaxel, or Enzalutamide is the most effective in treating Castration-resistant Prostate Cancer that has spread

NCT ID: NCT03337724 Not yet recruiting - Breast Cancer Clinical Trials

A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

IPATunity130
Start date: December 12, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2−) breast adenocarcinoma who are not suitable for endocrine therapy.

NCT ID: NCT03333317 Recruiting - Clinical trials for Respiratory Syncytial Viruses

A Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus

Start date: November 24, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine in hospitalized infants and children who are infected with respiratory syncytial virus (RSV) the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative real-time reverse transcriptase polymerase chain reaction (qRT-PCR).

NCT ID: NCT03332459 Not yet recruiting - Clinical trials for Respiratory Syncytial Virus Infections

A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection

Start date: January 5, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this long-term follow-up (LTFU) study is to evaluate the incidence of the clinical diagnosis of asthma and the frequency of wheezing in infants and children with respiratory syncytial virus (RSV) infection who were treated with (lumicitabine or placebo) and have completed their last planned study‑related visit in a feeding Phase 2 study (64041575RSV2004).

NCT ID: NCT03329846 Recruiting - Melanoma Clinical Trials

An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma

Start date: November 29, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to see if BMS-986205 combined with nivolumab, compared to nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to be removed by surgery, and has not previously been treated