Indiana Paid Clinical Trials

Few evidence-based programs exist to support children and families affected by sociopolitical conflict, despite documented evidence of their heightened risk for emotional and behavioral adjustment problems associated with exposure to conflict and violence at multiple levels of the social ecology (e.g., political, community, and family). Thus, a critical need exists for an evidence-based program to ameliorate the impact of political violence on the overall well-being of children and families. The current study will conduct a rigorous evaluation of a theoretically-driven, family-based intervention program in Palestine, including both the West Bank and Gaza. Firmly grounded in the cultural context of Palestine but with broad implications for individuals exposed to sociopolitical violence, the long-term goal of this project is to provide a family-focused intervention program (Promoting Positive Family Futures; PPFF) that may facilitate individuals' sense of safety and support in the context of chronic adversity. The objective is to evaluate this intervention program in the context of a randomized clinical trial (RCT) in the West Bank and Gaza (N=300). The central hypothesis is that the program will have direct positive effects on family conflict, parent psychopathology and parental security in the family as well as on adolescent emotional security in the family, with cascading effects on adolescent adjustment. Consistent with family systems theory, we further hypothesize that treatment effects on parents will mediate on the effects of the treatment on adolescent adjustment. The rationale is that bolstering resilience in family systems is a key approach to promoting positive functioning in families exposed to chronic violence. The hypothesis will be evaluated with three specific aims: 1) evaluate the efficacy of an evidence-based family support program; 2) examine process models of treatment change, and 3) examine interrelations between parent and child functioning. To achieve these aims, the study will be an RCT employing a longitudinal design (N=300) with multi-method assessments at baseline (T1), post-test (T2), 6-month follow-up (T3) and 12-month follow-up (T4). Families included in the study will be evenly divided between the West Bank (n=150) and Gaza Strip (n=150). Families will be randomized into the intervention condition (PPFF) or treatment as usual (TAU). Each territory will have an implementing partner, and implementing partners and investigators will work together to ensure the study procedures are implemented in parallel across sites. Data collection will be conducted by trained research staff from a third-party survey and policy research organization. The proposal seeks to shift current research and clinical paradigms in these contexts by employing novel theoretical concepts, approaches, and methodologies. The contribution will be significant by 1) further developing new directions for empirically-based interventions in these high-risk contexts, and 2) advancing a relatively brief, cost-effective program that can be readily implemented to help children and families exposed to continuing conflict in Palestine, with the potential to be brought to scale in other contexts. Read Less

This study is designed to test the effectiveness of a psychoeducation-based program to address communication and conflict resolution in families, thereby supporting mental health in children and their caregivers. Read Less

This study is designed to evaluate a preventive intervention program designed to support families (parents and typically developing adolescent siblings) that include a child with an intellectual and/or developmental disability. Participant families will be randomly assigned to either the treatment condition, in which they will receive psychoeducation and communication coaching over a four-week period, or the control condition, in which they will receive self-study materials. All subjects will participate in a pre-test assessment and three post-test assessments over the course of the year. Read Less

Multi-center, prospective non-interventional study to collect data on the early use of Adstiladrin in the US and Israel. Data will be collected from patients and prescribing physicians in a real-world setting Read Less

The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the incidence of severe oral mucositis in patients with head and neck cancers. All patients in this study will receive 7 weeks of standard of care radiation therapy given with the chemotherapy agent, cisplatin. Patients will receive RRx-001 or placebo before start of standard of care treatment. Read Less

The proposed of this randomized, double blinded, placebo-controlled study is to assess the effect of SAMe compared to placebo in patients with alcoholic cirrhosis Child Class A and B. The primary objective of the study is to test relationship between SAMe (S-adenosylmethionine) supplement on liver function. The hypothesis is that SAMe supplement will improve liver function in patients with alcoholic liver disease. The improvement in liver function will lead to the reduction in all-cause mortality in patients with alcoholic cirrhosis in those who receive SAMe supplement when compared to those receiving placebo. Read Less

This randomization study is to compare both intrathecal morphine and intravenous methadone, which are both standard of care, for pain management in patients undergoing retroperitoneal lymph node dissections for primary testicular cancer. Investigators plan to compare their analgesic effectiveness at different postoperative time intervals. Read Less

Tooth wear, resulting from gradual loss of dental hard tissue due to mechanical and chemical factors, impacts tooth structure, texture, and function. It affects quality of life, with varying prevalence (26.9% to 90.0%), and is traditionally detected visually during check-ups, often at advanced stages. Monitoring alterations in tooth shape via intraoral scanners aids early detection, but restoration remains challenging. Prevention through early detection is vital, as patients may not fully comprehend tooth structure loss until visible. Recently, statistical shape analysis (SSA) used to learn the tooth anatomy and define a reference shape (biogeneric tooth) using. However, assuring landmark consistency is challenging mostly due to biases of the operator. Recently, a robust method called MEG-IsoQuad offered automated, isotopological remeshing. Combining this with SSA holds promise for diagnostic and simulation purposes. This study aims to assess the reliability of a remeshing-SSA approach for altered and intact premolar analysis and compare machine learning algorithms for simulating the shape of the initially intact tooth or future altered one. The clinical perspective of the current work offers possibilities to: * Prevent future tooth wear by detecting it at an early stage; and communicate better to the patient by presenting him/her potential future altered teeth * Simulate the adapted reconstruction for the altered tooth by simulating the initially intact one Read Less

The goal of this FID-007 Clinical Trial is to compare the efficacy of different dosing regimens of FID-007 in combination with Cetuximab in patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). The main questions it aims to answer are: to evaluate the efficacy, and to characterize the safety and tolerability. Eligible participants will be enrolled and randomized to 1 of 2 arms of FID-007 with fixed-dose Cetuximab in each 28-day cycle. Read Less

Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study. Read Less

This study is examining the use of Tezampanel (TZP) for treatment of Opioid Withdrawal Syndrome (OWS) in participants with Opioid Use Disorder (OUD). Participants will receive TZP or placebo (PBO) daily on Days 2 - 7 during a 7-day inpatient stay at the research center to determine safety, pharmacokinetic (PK) assessment, and efficacy of TZP for OWS. Read Less

This IRB will cover a current clinical trial (NCT04244604) that was started at Auburn University (AU IRB#19-390), the Principal Investigator's prior institution, and is supported by his NIH Career Development Award (NHLBI K01HL147998). About nine out of ten Americans overconsume dietary salt. Compared to other racial groups, Black individuals are more prone to salt-sensitive hypertension and negative cardiovascular conditions associated with high salt intake. However, there is a critical need to determine the reasons behind and mechanisms that contribute to these racial disparities. Both acute (single meal) and chronic high-dietary sodium cause small but important increases in blood sodium concentration that are associated with altered blood pressure regulation and blood vessel dysfunction. However, racial differences in these measures have not been examined. This is important because Black individuals generally exhibit lower circulating concentrations of hormones (e.g., renin, aldosterone, angiotensin 2) that buffer changes in body sodium to regulate blood pressure, and this could make them more vulnerable to the negative effects of a high-sodium meal. Therefore, the purpose of this study is to determine whether there are racial differences in blood pressure regulation and blood flow after a high-sodium meal. The investigators will assess blood pressure regulation, blood vessel stiffness, and the blood vessel's ability to dilate before and after a high-salt meal and a low-salt control meal (both meals are low-salt tomato soup with varied added salt). The investigators will also collect blood and urine to measure sodium and determine biochemical changes that may be contributing to racial differences in cardiovascular function. Read Less