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NCT ID: NCT03198429 Recruiting - Domestic Violence Clinical Trials

Cluster RCT of Embedded Parenting Intervention to Prevent Recurrence and Reduce Impairment in Young Children Exposed to Domestic Violence

SafeUnderstood
Start date: October 31, 2016
Phase: N/A
Study type: Interventional

The current cluster randomized trial examines the efficacy of embedding two different parenting interventions within child protection services for young children (0 to 4) who have been exposed to domestic violence and who are at moderate to high risk for recurrent experiences of maltreatment. Interventions are "embedded" in recognition of the significant role played by child protection case workers in identifying families in need of intervention, referring/engaging families in intervention, and being able to use information resulting from intervention (e.g., reports from the intervention program, observations of parenting behaviour changes made as a result of intervention) to improve decision-making in their child protection practice. Thus in this trial, ongoing child protection case workers for families are randomly assigned to receive professional development training, supervision support, and priority client access to parenting interventions in the following four conditions: a) embedded mother-child dyadic intervention (Mothers in Mind); b) embedded fathering intervention (Caring Dads); c) both mother-child dyadic and fathering intervention; d) service as usual. Mothers in Mind (MIM) is a dyadic mother-child intervention aimed at preventing child impairment resulting from exposure to domestic violence. Intervention focuses on increasing mothers' awareness of the impact that exposure to family violence/trauma may have had on their infants and themselves as mothers, helping identify and promote positive parenting skills such as sensitivity and responsiveness to infant needs, promoting parental competence and emotional closeness and decreasing mothers' social isolation. Mothers in Mind uses an attachment and trauma-informed psycho-educational process approach in 12 weekly sessions (10 group and 2 individual). Caring Dads (CD) aims to prevent recurrence of child exposure to domestic violence by intervening with fathers. Caring Dads includes 15 group sessions, an individual intake, and two individual sessions to set and monitor specific behaviour change goals. Major aspects of innovation in the Caring Dads program include the use of a motivational approach to engage and retain men in intervention, consistent emphasis on the need to end violence against children's mothers alongside of improving fathering; program content addressing accountability for past abuse; focus on promoting child-centered fathering over developing child management skills; and a model of collaborative practice with child protection. Hypotheses are posed for differential outcomes among child protection workers (level of randomization) and for children who are the subject of the child protection referral (nested within workers). At the level of the individual child (primary outcome) it is hypothesized that there will be lower rates of re-referral for children of families on the caseloads of child protection workers assigned to the embedded CD, MIM and combined intervention than for those on the caseloads of workers in the service as usual condition. At the worker level (secondary outcomes), outcomes are hypothesized in two areas: 1) worker skill in conceptualizing risk and need in cases of child exposure to domestic violence and 2) increased self-efficacy for referring to and collaborating with embedded interventions. Specifically, we hypothesized that following training and at 12-month follow-up, workers in the CD/MIM intervention and combined CD and MIM condition will have greater case conceptualization skills in responding to hypothetical cases as compared to workers in the treatment as usual condition. We further hypothesize that assignment to an intervention condition will lead workers to report greater self-efficacy for collaborating with embedded parenting interventions than workers in the treatment as usual condition post-training and at 12-months follow-up.

NCT ID: NCT03192618 Recruiting - Clinical trials for Hepatocellular Carcinoma

The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

Start date: July 1, 2017
Phase: Phase 3
Study type: Interventional

To compare The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy.

NCT ID: NCT03185611 Recruiting - Crohn Disease Clinical Trials

Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Recurrence in Crohn's Disease

Start date: May 18, 2017
Phase: Phase 3
Study type: Interventional

Some studies have shown that rifaximin is effective in the management of Crohn's Disease. Meanwhile, its adverse effect is tolerable. But no study has been conducted to assess its effect on preventing postoperative recurrence. Thus, we conduct a randomised controlled study to assess the effect of rifaximin combined with thiopurine on preventing postoperative endoscopic recurrence in Crohn's disease, compared with thiopurine. The primary endpoint is the rate of endoscopic recurrence at 6 months.

NCT ID: NCT03183115 Recruiting - Clinical trials for Esophageal Squamous Cell Neoplasm

RFA to Prevent Metachronous Squamous Neoplasia Recurrence After Complete Endoscopic Submucosal Dissection

Start date: April 18, 2016
Phase: N/A
Study type: Interventional

Esophageal cancer is a highly lethal disease, and its incidence is still increasing in the world. Recent advances in image-enhanced techniques such as Lugol chromoendoscopy and narrow band imaging, the number of patients with early esophageal squamous cell neoplasias (ESCNs) detected has markedly increased. Endoscopic submucosal dissection (ESD) enables en bloc resection of the neoplasia, and the resected specimen allows for a pathological assessment to evaluate the curability. However, the patients who received complete ESD for early ESCNs frequently developed metachronous recurrence. The cumulative metachronous recurrence rate at 5 years was 50%, and the mean annual incidence of newly diagnosed metachronous tumors was 10%. Among them, those with "speckled" lugol staining pattern over the esophageal background mucosa have the highest risk and should be seen as a precancerous lesion of ESCCs. This issue is gaining attention in the era of endoscopic treatment, but currently there was no appropriate strategy to prevent the tumor recurrence in these high-risk subjects. Endoscopic radiofrequency ablation (RFA) is a rapidly evolving therapeutic modality, and recent studies have shown its efficacy and safety for eradicating for flat type early ESCNs. To search a best strategy for the prevention of ESCNs, the investigators thus propose a hypothesis that the preemptive RFA for esophageal "speckled" lugol background mucosa may prevent the metachronous neoplastic recurrence after complete endoscopic resection.

NCT ID: NCT03164460 Recruiting - Clinical trials for Recurrent Head and Neck Carcinoma

Stereotactic Body Radiation Therapy or Intensity Modulated Radiation/Proton Therapy in Treating Patients With Recurrent Head and Neck Cancer

Start date: May 22, 2017
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well stereotactic body radiation therapy or intensity modulated radiation/proton therapy works in treating patients with head and neck cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Intensity modulated radiation/proton therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. It is not yet known whether stereotactic body radiation therapy or intensity modulated radiation/proton therapy may work better in treating patients with head and neck cancer.

NCT ID: NCT03155620 Recruiting - Malignant Glioma Clinical Trials

Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)

Start date: July 31, 2017
Phase: Phase 2
Study type: Interventional

This Pediatric MATCH screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.

NCT ID: NCT03150550 Recruiting - Clinical trials for Alcohol Use Disorder

Study of Mindfulness Practice Efficacy in Alcoholic Relapse Prevention

Mindfulness
Start date: January 21, 2017
Phase: N/A
Study type: Interventional

Among behavioral cognitive psychotherapies, new "Mindfulness" interventions allow patient to identify, pay attention and accept external (sensory stimuli) and internal (cognition and emotions) phenomena. This "to do with" training has yielded promising results in stress management, prevention of depressive relapse, management of craving and an increase in self-efficacy. Few studies (none in France) have attempted to measure the efficacy of this technique on alcohol relapse, in particular by comparing it with a usual management strategy (conventional relapse prevention therapy). The main objective of this study is to compare the efficacy on alcoholic relapse (measured in the "first glass" consumed), from a Mindfulness therapeutic program to a conventional Relapse Prevention program. Secondary objectives are to demonstrate the efficacy of this program on craving, self-efficacy, and secondary endpoints of relapse (massive alcoholism, number of alcoholisation days).

NCT ID: NCT03150004 Recruiting - Clinical trials for Acute Myeloid Leukemia

Efficacy and Pharmacogenomics of Cladribine Based Salvage Chemotherapy in Patients With Relapse/Refractory and Secondary Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS)

Start date: June 14, 2017
Phase: Phase 2
Study type: Interventional

This is a prospective phase II clinical study planned to be conducted at the Medical College of Wisconsin (MCW). After meeting the study criteria and enrollment, patients will be treated with a cladribine based salvage regimen and followed at periodic intervals to determine the primary and secondary objectives.

NCT ID: NCT03147885 Recruiting - Clinical trials for Diffuse Large B-Cell Lymphoma

Selinexor Plus Combination Chemotherapy in Treating Patients With Advanced B Cell Non-Hodgkin Lymphoma

Start date: June 20, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This phase Ib/II trial is aimed at studying the combination of a drug named Selinexor (selective inhibitor of nuclear export) in combination with standard therapy for B cell Non-Hodgkin's lymphoma called R-CHOP. The investigators will establish maximum tolerated dose of Selinexor in combination with RCHOP and also study the efficacy of this combination for therapy of B cell Non-Hodgkin's lymphoma. Giving Selinexor plus chemotherapy may work better in treating patients with B cell non-Hodgkin lymphoma.