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NCT02718417
This is a Phase 3, open-label, international, multi-center, efficacy, and safety study of avelumab in combination with and/or following platinum-based chemotherapy. Eligible patients must have previously untreated, histologically confirmed Stage III-IV epithelial ovarian (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) and be candidates for platinum-based chemotherapy. The primary purpose of the study is to demonstrate if avelumab given as single agent in the maintenance setting following frontline chemotherapy or in combination with carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by observation in this population of newly diagnosed ovarian cancer patients.
NCT00339950
The CONCeRN Trial is a multi-center study of asymptomatic women between the ages of 40 and 75 referred to regional military medical centers for routine colorectal screening. The primary purpose of the main study is to determine the extent to which advanced neoplastic lesions will be missed if clinicians only perform sigmoidoscopies rather than full colonoscopies as a screening procedure and to resolve current debate about the significance of sigmoidoscopic detection of single, small, tubular adenomas (i.e., do they imply greater risk for large adenomatous polyps or colorectal cancer at other sites beyond the reach of the sigmoidoscope, or is there no increased risk?). Women enrolled in the trial receive colonoscopy during which all identified polyps are removed and also during which two pinch biopsies of apparently-normal tissue are taken. In addition, before the colonoscopy is performed, patients wil have blood drawn and answer a brief questionnaire on risk factors for colorectal cancer. The sub-study proposes to add on a more extensive questionnaire to assess dietary and other lifesyle factors potentially related to colorectal cancer, and to draw additional blood for assessment of nutritional status and for analysis of genetic polymorphisms related to colorectal cancer. With the additional information available from these questionnaires and blood samples, it will be possible to explore the extent to which various dietary and genetic risk factors are related to colorectal polyps in asymptomatic women of average risk for disease.
NCT03745222
This is a Phase 3, randomized, double-blind, placebo-controlled multicenter global study designed to compare the efficacy and safety of tislelizumab in combination with concurrent chemoradiotherapy (cCRT) followed by tislelizumab monotherapy versus cCRT alone, and tislelizumab given sequentially after cCRT versus cCRT alone, in newly diagnosed stage III subjects with locally advanced, unresectable non-small cell lung cancer (NSCLC). The primary endpoint is centrally-assessed progression free survival (PFS) in the intent-to-treat (ITT) population. .
NCT00342875
Data from the new cancer atlas covering the period 1974 1994 indicates that deaths from bladder cancer among white men and women are elevated in the northeastern United States, particularly the northern parts of New England. The reason for these elevated rates of incidence of and deaths from bladder cancer is unknown. Only part of the excess risk can be explained by exposure to the textile and leather industries. The purpose of this study is to determine the factors that contribute to the high rates of incidence of and death from bladder cancer in northern New England. The main objectives are to: * estimate the risk of developing bladder cancer associated with inorganic arsenic in drinking water, other water contaminants, tobacco use, occupational exposures, residential proximity to industrial sites, dietary factors, ethnicity, and use of wood-burning stoves. * estimate the extent to which water containing inorganic arsenic explains the increased rates of bladder cancer. * estimate the extent to which exposure to other risk factors explains the increased rates. * evaluate risk of bladder cancer according to genetic factors. * examine interactions of these factors with tobacco use, occupational exposure, and environmental exposure to arsenic and other compounds. All people ages 30 79 with confirmed cases of bladder cancer will be eligible for the study. Twelve hundred people with bladder cancer and twelve hundred individuals with no previous bladder cancer will be included. After potential participants are recruited and agreement is obtained over the telephone, they will complete a calendar and collect toenail clippings prior to the home interview. During the home visit, an investigator will administer a computer-assisted personal interview, collect drinking water samples and the clippings, and obtain a global positioning satellite reading. Other biological samples, such as saliva samples, urine, and blood, may be requested. Private wells at any previous homes of participants will also be sampled. The location of previous homes will be determined and the current homeowner will be asked to allow sampling of the well. The associations between bladder cancer and environmental exposures will be examined and the extent to which exposures to such risk factors explain the elevated mortality and incidence in northern New England will be estimated. ...
NCT02753595
The primary objective for the study is as follows: For the Phase 1b - to determine safety tolerability and recommended Phase 2 dose (RP2D) of eribulin mesylate in combination with PEGylated recombinant human hyaluronidase (PEGPH20) in participants with Human Epidermal Growth Factor Receptor (HER2)-negative metastatic breast cancer (MBC) previously treated with up to two lines of systemic anticancer therapy in the metastatic setting. For the Phase 2 - to evaluate objective response rate (ORR) of eribulin mesylate in combination with PEGPH20 in participants with HER2-negative, High-Hyaluronan (HA)-high, MBC previously treated with up to 2 lines of systemic anticancer therapy in the metastatic setting.
NCT03114657
This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The primary efficacy assessment will be performed at 105 weeks. The participants who do not enter open-label extension will enter for a long term follow-up period for up to 52 weeks after the last crenezumab dose (Week 153).
NCT03093324
The objectives of this study are to evaluate the utility of two gastrointestinal (GI) symptom scales (Individual GI Symptom and Impact Scale {IGISIS} and Global GI Symptom and Impact Scale {GGISIS}) in assessing GI tolerability in adult subjects with RRMS after administration of ALKS 8700 or Dimethyl Fumarate (DMF) in Part A, to compare the GI tolerability of ALKS 8700 and DMF in adult subjects with RRMS using IGISIS and GGISIS in Part B, and to Evaluate the safety and tolerability of ALKS 8700 in adult subjects with RRMS in Parts A and B.
NCT04129567
Migraine is a significant health problem in the United States with 34 million Americans suffering from migraine attacks every year. High-flow oxygen has been successfully used in several clinical studies. Vasoconstriction of blood vessels in the scalp has been proposed as a possible mechanism of action. Some researchers have suggested that the cooling effect of high-flow dry oxygen may be in part responsible for the pain relief. The main objective is to test the hypothesis that the pain relief obtained during high-flow trans-nasal gas therapy is due to the cooling effect of dry gas on the nasal mucosa. The study entails recruiting patients from a headache clinic, being escorted to the Institute for Clinical and Translational Research (ICTR) Johns Hopkins Bayview and randomized into different groups (humidified oxygen, dry air, humidified air and dry oxygen). Eventually, patients will be asked to fill out a questionnaire on pain, nausea, sound and light sensitivity graded on a scale of 1-10. Readings are noted at baseline, 15 mins, 2 hours and 24 hours post-therapy.
NCT03719053
This study examines tenofovir (TFV) drug concentrations in adults one day after taking a single dose of Truvada® - a pill used to prevent and treat HIV infection. The results of this study will be used to improve the (efficacy/accuracy) of a white coat adherence (WCA) detection test - a blood test that can be used to indicate medication adherence. Participants will receive one dose of Truvada®, and provide 2 total samples of blood.
NCT02709980
The current study seeks to evaluate cognitive behavior therapy for insomnia (CBT-I), a non-medication treatment, in recent TBI patients compared to a sleep education control intervention. Patients will participate in CBT-I treatment (or sleep education treatment) weekly for six weeks, and will have a 3-months follow-up visit in order to examine the efficacy and time course of treatment. In addition, participants will complete several self-report questionnaires in order to examine sleep and neuropsychiatric symptoms throughout treatment.
NCT00927173
The purpose of the study is to evaluate the efficacy and safety of deep brain rTMS, (Transcranial Magnetic Stimulation), a new experimental procedure using the H-Coil, in subjects with Major Depressive Disorder that have been previously unsuccessfully treated with antidepressant medications.
NCT02279160
The study was conducted as a placebo-controlled, randomized, 22-week double-blind study which included a dose titration period. An additional transition period occurred for those patients who elected to enroll into the open-label extension study, APD811-007. A total of 61 patients with PAH were enrolled.
NCT02624570
The purpose of this study is to provide access to Midostaurin and gather additional safety data on the combination of Midostaurin and standard of care for adult patients with newly diagnosed Fms-like tyrosine kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who are eligible for standard induction and consolidation chemotherapy.
NCT04272645
This research is studying two experimental drugs, abemaciclib and atezolizumab, alone and in combination with each other, to learn about the safety and effectiveness of these treatments and their side effects. This is an investigational study treatment for adult men with metastatic castrate resistant prostate cancer (mCRPC) who have progressive disease despite previous treatment with androgen deprivation therapy (ADT). One group of men (men without a genetic mutation called "CDK12 loss") will receive abemaciclib therapy alone. Two other groups of men (men with CDK12 loss in one group and men without CDK12 loss in the other) will receive the combination of abemaciclib and atezolizumab. Another group of men with CDK12 loss will receive atezolizumab therapy alone.
NCT00847379
Duchenne/Becker muscular dystrophy (DMD/BMD) is a genetic disorder that develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability during childhood and teenage years. A specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of DMD/BMD in approximately 10-15% of boys with the disease. Ataluren (PTC124) is an orally delivered, investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 2b extension trial that will evaluate the long-term safety of ataluren (PTC124) in boys with nonsense mutation DMD/BMD, as determined by adverse events and laboratory abnormalities. The study will also assess changes in walking, muscle function, and other important clinical and laboratory measures.
NCT03592342
Participants with symptomatic Oral Lichen Planus lesions will be treated with Rivelin® patches containing either 0, 1, 5, or 20 μg clobetasol per patch. Each participant will apply up to 6 patches twice daily for 4 weeks.
NCT03026166
The purpose of this study is to assess the safety and efficacy of rovalpituzumab tesirine administered in combination with nivolumab or nivolumab and ipilimumab in participants with extensive-stage small cell lung cancer (SCLC).
NCT01611558
To assess the incidence of drug-related adverse events of Grade 3 or higher and the overall response associated with ipilimumab treatment
NCT00840749
Lung cancer remains the most frequent cause of cancer death in both men and women in the world. Surgical resection using lobectomy with mediastinal lymph node dissection or sampling has been a standard of care for operable early stage NSCLC. Several studies have reported high local control and survival using SBRT in stage I NSCLC patients. SBRT is now an accepted treatment for medically inoperable patients with stage I NSCLC and patients with operable stage I lung cancer are entered on clinical protocols. The purpose of this study is to conduct a phase III randomized study to compare CyberKnife SBRT with surgery, the current standard of care for stage I operable NSCLC.
NCT00368069
This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.