New Hampshire Clinical Trials

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INCB024360 and Vaccine Therapy in Treating Patients With Stage III-IV Melanoma
This pilot phase II trial studies how well INCB024360 (indoleamine 2,3-dioxygenase 1 [IDO1] inhibitor INCB024360) and vaccine therapy work in treating patients with stage III-IV melanoma. IDO1 inhibitor INCB024360 may stop the growth of tumor cells by blocking some of [more...]  the enzymes needed for cell growth. Vaccines made from peptides and antigens may help the body build an effective immune response to kill tumor cells. Giving IDO1 inhibitor INCB024360 with vaccine therapy may be an effective treatment for advanced melanoma.
Status: Recruiting Start Date: September 2013 Completion Date: 
Logitudinal Study of Patients With Opioid-Induced Constipation
The main objective of the study is to calculate the rate of inadequate response to laxatives in a cohort of patients with OIC, as well as to gain a detailed understanding of the burden of illness of OIC by documenting the characteristics of patients [more...]  seeking usual care in the laxative-inadequate responders (LIR) and the laxative-adequate responders (LAR) opioid user subgroups. The study will do so by evaluating the burden of illness impact of OIC on each of the opioid user patient sub-groups of interest in terms of clinical outcomes (including symptoms), resource utilization (laxative use, OIC-related MD visits, hospitalizations, and ER visits), economic burden, and HRQL. This study also aims to identify "predictors" of outcomes of interest and will evaluate physician and patient perceptions of the severity and burden of OIC.
Status: Recruiting Start Date: October 2012 Completion Date: January 2014
Phase 2, Randomized, Double Blinded, Study of Nivolumab (BMS-936558) in Combination With Ipilimumab vs Ipilimumab Alone in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
The primary purpose of this study is to compare the objective response rate (ORR) as determined by investigators, of Nivolumab combined with Ipilimumab versus Ipilimumab monotherapy in subjects with unresectable or metastatic melanoma
Status: Recruiting Start Date: August 2013 Completion Date: May 2015
Use of Radiofrequency Ablation for RGB Salvage
The present study will assess the feasibility of using endoscopic radiofrequency ablation (RFA) to treat the gastric pouch and stoma with the intent to cause tissue contraction and decreased compliance after a failed Roux-en-Y gastric bypass.
Status: Recruiting Start Date: July 2013 Completion Date: December 2015
A Clinical Trial for the Treatment of Depression With Repetitive Transcranial Magnetic Stimulation (rTMS)
The purpose of this study is to determine whether the Cervel Neurotech rTMS device is safe and effective in the treatment of depression in people who do not get better with antidepressant medications or cannot take antidepressant medications.
Status: Recruiting Start Date: July 2013 Completion Date: 
A Study of LY2875358 in Non Small Cell Lung Cancer (NSCLC) Participants
The primary purpose of this study is to evaluate the efficacy of the study drug known as LY2875358, administered alone or in combination with a second drug named Erlotinib, in participants affected by a defined type of lung cancer (MET biomarker diagnostic positive [more...]  Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent treatment with Erlotinib.
Status: Recruiting Start Date: August 2013 Completion Date: November 2014
Deep Brain Stimulation (DBS) for Treatment-Resistant Depression (TRD)
In this pilot study, we propose to test whether high frequency stimulation of the subcallosal cingulate (SCC) is a safe and efficacious antidepressant treatment in five TRD patients, to compare the effects of left-sided vs. right-sided stimulation, and to [more...]  investigate potential mechanisms of action of this intervention. Importantly, this study will be used to assess the need for and assist in planning a larger, more definitive trial of SCC DBS for TRD.
Status: Recruiting Start Date: July 2013 Completion Date: December 2016
An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis
The purpose of this study is to investigate the long-term safety and any side effects of baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis study. The study provides for 2 years of additional treatment with baricitinib, [more...]  but may be extended to allow for continued treatment for up to 5 years after evaluation of the safety profile of baricitinib.
Status: Recruiting Start Date: June 2013 Completion Date: June 2020
Phase I/II Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered Subcutaneously in Patients With B-cell NHL
An open-label, dose-escalation trial of the safety, tolerability, pharmacokinetics (PK), biological, and clinical activity of DI-Leu16-IL2 administered to patients with CD20 (B-lymphocyte antigen CD20) positive Non-Hodgkin Lymphoma (NHL) that have failed standard rituximab-containing therapy. Following peripheral blood B cell [more...]  depletion with rituximab (if needed) each patient will receive DI-Leu16-IL2 administered as a subcutaneous (SC) injection for three consecutive days every three weeks (21 day cycle). Three to six (3-6) patients will be enrolled in each cohort. Patients may receive 6 cycles of DI-Leu16-IL2 approximately thrice weekly for 3 weeks for a total of 18 doses.
Status: Recruiting Start Date: July 2013 Completion Date: July 2015
Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery
This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive [more...]  radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer
Status: Recruiting Start Date: August 2013 Completion Date: August 2028
A Study on the Impact of Methotrexate Discontinuation on the Efficacy of Subcutaneous RoActemra/Actemra (Tocilizumab) With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis
This randomized, multicenter, double-blind, parallel group study will evaluate the impact of methotrexate discontinuation on the efficacy of subcutaneous RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to current methotrexate therapy. [more...]  Patients will be initiated on RoActemra/Actemra 162 mg weekly or every 2 weeks, remaining on a stable dose of methotrexate. At Week 24, patients achieving a disease activity score (DAS28)
Status: Recruiting Start Date: July 2013 Completion Date: December 2015
Differentiating the Effects of Substance P and Beta-endorphin
In previous studies we demonstrated that endogenous opioids (inhibitory neuropeptides) modulate the perception of breathing difficulty in patients with chronic obstructive pulmonary disease (COPD) (ERJ 2009;33:771; J COPD 2011;8:160). Recently, we found that antagonism of substance P (an [more...]  excitatory neuropeptide) with aprepitant did not affect the perception of breathing difficulty. However, after administration of aprepitant, blood levels of both substance P(+ 54 ± 39%) and beta-endorphin (+ 27 ± 17%) increased significantly. As these blood levels reflect cellular/tissue activity, we postulated that the concomitant release of excitatory (substance P) and inhibitory (beta-endorphin) neuropeptides had opposing effects (counterbalanced each other) on the perception of breathing difficulty. The objective of the present study is to further examine the possible role of substance P on the perception of breathlessness. We propose to administer oral aprepitant and oral placebo in a randomized clinical trial in patients with COPD. However, four hours after patients take these medications, intravenous naloxone will be administered in order to block the effects of endogenous opioids (beta-endorphin) on opioid receptors. Five minutes later, patients will breathe thru a tube with fine wire mesh to provoke breathing difficulty, and then provide ratings of the intensity and unpleasantness of breathlessness every minute. The two competing hypothesis of the study are: 1. if breathlessness ratings with aprepitant/naloxone = placebo/naloxone, then substance P has no effect on perception of breathing difficulty; 2. if breathlessness ratings with aprepitant/naloxone ≠ placebo/naloxone, then substance P has an effect on perception of breathing difficulty.
Status: Recruiting Start Date: July 2013 Completion Date: 
Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2)
This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks), placebo-controlled study to assess the efficacy and safety of GFF MDI (PT003), GP MDI (PT001), and FF MDI (PT005) compared with Placebo MDI in subjects with moderate to very [more...]  severe COPD.
Status: Recruiting Start Date: July 2013 Completion Date: 
A Proof-of-principle Study of Hyperbaric Oxygen as a Radiosensitizer Prior to Stereotactic Radiosurgery for Brain Metastases
Patients with brain metastases who are candidates for treatment with stereotactic radiosurgery (SRS) are potential study participants. SRS delivers high-energy, precisely-focused radiation to each brain metastasis to shrink the tumor, and is the standard-of-care for patients with these tumors. [more...]  Oxygen enhances the damaging effects of radiation on tumor cells. Hyperbaric oxygen (HBO) therapy increases oxygen levels in all kinds of tissues, including tumors. The purpose of this trial is to study whether it is feasible to treat patients with HBO just prior to receiving SRS, given the timing constraints of treating sequentially with HBO and then SRS. Patients will undergo HBO treatment followed by the placement of a Gill-Thomas-Cosman head frame then transported ,via stretcher, to receive SRS. The transfer and placement of the head frame needs to be completed within the 15minute time frame. The trial's secondary objectives are to determine whether it has any effects on outcomes and quality of life. As part of study participation patients will be asked to complete quality of life questionnaires as well as mini mental status questionnaires. These will be done prior to treatment and at follow up appointments throughout the next 3 years while participating in the study. Patients will be given the option to participate in the optional bio marker blood draw study which would require patients to have blood drawn at three time points, pre-treatment, the day after treatment and at their first follow up visit.
Status: Recruiting Start Date: May 2013 Completion Date: August 2016
A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes
This trial is conducted in Africa, Asia, Europe, North and South America. The aim of the trial is to compare efficacy and safety of insulin degludec and insulin glargine in insulin naïve subjects with type 2 diabetes.
Status: Recruiting Start Date: June 2013 Completion Date: May 2014
Evaluating the Expression Levels of MicroRNA-10b in Patients With Gliomas
MicroRNAs (miRNA) are molecular biomarkers that post-transcriptionally control target genes. Deregulated miRNA expression has been observed in diverse cancers. In high grade gliomas, known as glioblastomas, the investigators have identified an oncogenic miRNA, miRNA-10b (mir-10b) that is expressed [more...]  at higher levels in glioblastomas than in normal brain tissue. This study tests the hypothesis that in primary glioma samples mir-10b expression patterns will serve as a prognostic and diagnostic marker. This study will also characterize the phenotypic and genotypic diversity of glioma subclasses. Furthermore, considering the critical function of anti-mir-10b in blocking established glioblastoma growth, the investigators will test in vitro the sensitivity of individual primary tumors to anti-mir-10b treatment. Tumor, blood and cerebrospinal fluid samples will be obtained from patients diagnosed with gliomas over a period of two years. These samples will be examined for mir-10b expression levels. Patient survival, as well as tumor grade and genotypic variations will be correlated to mir-10b expression levels.
Status: Recruiting Start Date: May 2013 Completion Date: December 2015
A Study Of MPDL3280A in Patients With PD-L1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
This multicenter, single-arm study will evaluate the efficacy and safety of MPDL3280A in patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Patients will receive an intravenous dose of 1200 mg MPDL3280A on Day 1 of 21-day [more...]  cycles for a maximum of 16 cycles.
Status: Recruiting Start Date: April 2013 Completion Date: May 2015
Olaparib Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.
Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.
Status: Recruiting Start Date: August 2013 Completion Date: January 2022
T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial)
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that [more...]  research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not approved this drug for use patients undergoing adjuvant treatment for HER2+ breast cancer. Trastuzumab emtansine (T-DM1) is a drug that may stop cancer cells from growing. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to prevent the recurrence of breast cancer in this research study. The use of T-DM1 in this research study is experimental, which means it is not approved by any regulatory authority for the adjuvant treatment of HER2-positive breast cancer. However, it FDA-approved for metastatic HER2-positive breast cancer. T-DM1 has caused cancer cells to die in laboratory studies. In preclinical studies, this drug has prevented or slowed the growth of breast cancer. The breast cancer treatments (paclitaxel and Trastuzumab) used in this study are considered part of standard-of-care regimens in early breast cancer. A standard treatment means that this is a treatment that would be accepted by the majority of the medical community as a suitable treatment for your type of breast cancer. In this research study, the investigators are looking to see if the study drug T-DM1 will have less side effects than traditional HER2-positive breast cancer treatment of trastuzumab and paclitaxel. The investigators are also hoping to learn about the long term benefits and disease-free survival of participants who take the study drug T-DM1 in comparison to those participants to take the combination of trastuzumab and paclitaxel.
Status: Recruiting Start Date: May 2013 Completion Date: 
NIR Hypoxia Imaging of Breast Tumor Response to Neoadjuvant Chemotherapy in Vivo
The purpose of this study is to determine whether an experimental alternative imaging method, Near Infrared Spectroscopy (abbreviated as NIR), can be used with a controlled respiratory system to examine the breasts for cancer. The NIR system uses light beams to [more...]  produce an image or picture of the inside of the breast. The respiratory system will help researchers get more information about the breast tissue by changing the amount of oxygen the tissue receives during NIR imaging.
Status: Recruiting Start Date: August 2010 Completion Date: December 2015
Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer
The purpose of this study is to determine whether four new alternative imaging methods can be used to follow the response of breast cancer to the treatment patients are being given. These methods produce an image of the inside of the breast so that [more...]  doctors can better decide whether breast cancer is responding to therapy. An important part of the study is to examine the same person with all methods in order to directly compare results. The four methods are: MRI Elasticity Imaging (abbreviated MRE), Electrical Impedance Spectroscopy (abbreviated EIS), Microwave Imaging and Spectroscopy (abbreviated MIS), Near Infrared Spectroscopy (abbreviated NIR). In addition to the experimental imaging methods, patients may also undergo a contrast-enhanced MRI, and/or additional mammography, which will help researchers compare the experimental methods. These additional examinations are accepted diagnostic procedures; they are not experimental. Some participants will have one or both of these additional examinations if clinically indicated.
Status: Recruiting Start Date: September 2006 Completion Date: 
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Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Participants often receive the best healthcare available for their condition.

Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. Trials are federally regulated with strict guidelines to protect participants.

New Hampshire Clinical Trials Information presented on is not intended to be a substitute for qualified medical advice visit or treatment with a real physician. We are not physicians. Always consult with a medical doctor (MD). is a website dedicated to listing clinical research studies in human subjects, including those specifically related to New Hampshire. Clinical research trials and medical trials take place in hundreds of cities across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectiveness of new treatments and drugs. The purpose of the studies is to answer specific human health questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions. Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Many times the participants receive treatment for free, and sometimes they are paid for their time. Participants often receive the best healthcare available possible for their condition. Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. U.S. - based New Hampshire studies are federally regulated with strict guidelines to protect patients.

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