About 975,213 results

Relation of Skin Closure Method to Groin Wound Infections After Proximal Femoral Artery Exposure.

Sep 17th, 2021 - Summary of the research plan Background - According to published articles the frequency of groin wound infections after peripheral revascularization varies substantially depending on the source from 5% up to 27%. Aims of the study - The aim of this randomized clinical trial is to evaluate whether the number of groin wound infections can be reduced with an intradermal skin suture compared to the...

Tooth and Tissue Sample Collection During Wisdom Teeth Removal

Sep 17th, 2021 - Objective The objective of this protocol is to evaluate and provide treatment for subjects who have a clinical indication for the routine extraction of dental third molar wisdom teeth with the aim to allow investigators to maintain their expertise in dental clinical care, gain additional knowledge about oral health and to utilize surgical waste collected from these patients for research studies...

TAP vs Caudal Block Using Dexmedetomidine/ Bupivacaine for Post Operative Analgesia

Sep 17th, 2021 - Ultrasonography guidance, by virtue of real-time visualization of the muscle layers and fascial planes, has significantly facilitated practice of regional nerve blockade for it offers confirmation of the spread of the local anesthetic drug in the correct space. Interestingly, there has been a reinvigoration of interest in ultrasonography-guided transversus abdominis plane block in children sinc...

Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)

Sep 17th, 2021 - Background: PD-1/PD-L1 signaling appears to be a major inhibitor of activated T cell anti-tumor immune responses. The rapid, deep and durable responses seen in various malignancies with PD-1/PD-L1 targeted agents demonstrate that blockade of this axis is key to facilitating immune responses within the tumor microenvironment (TME). Prostate cancer is poorly recognized by T cells. Lack of an immu...

Platelet Rich Plasma Versus Placebo for the Treatment of Greater Trochanteric Pain Syndrome (HiPPO Trial)

Sep 17th, 2021 - What is the problem being addressed? Greater trochanteric pain syndrome (GTPS), also known as trochanteric bursitis, is a painful condition characterised by pain around the greater trochanter usually affecting middle aged women (1). It was first described, as trochanteric bursitis in 1958 (2). Further details on the clinical symptoms published in 1978 as pain over the greater trochanter on walk...

Telemedicin Counselling for Medical Abortion

Sep 17th, 2021 - The guidance on Safe abortion technology by the World Health Organization (WHO 2012) suggests the evaluation of internet provision and telemedicine, as further alternative service delivery channels of safe abortion, as a subject for future research (WHO 2012) Our studies have shown that telemedicine and provision of medical abortion through wow is safe, acceptable and with outcomes similar to m...

Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB

Sep 17th, 2021 - To collect the usage information of Deltyba in actual clinical settings for the management of resistance to Deltyba

A Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Steroid Dependent/Refractory Chronic Graft Versus Host Disease (cGVHD)

Sep 17th, 2021 - The purpose of this study is to evaluate efficacy of ibrutinib in Japanese participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (complete response [CR] and partial response [PR] defined by National Institutes of Health [NIH] consensus development project criteria [2014]).

A Long-term Extension Study of PCI-32765 (Ibrutinib)

Sep 17th, 2021 - This is an open-label (identity of assigned study drug will be known) study designed to collect long-term safety and efficacy data and provide ibrutinib access to participants in completed ibrutinib studies. PCI-32765 (Ibrutinib) is a first-in-class, potent, orally-administered, covalently-binding small molecule inhibitor of bruton's tyrosine kinase. "PCI-32765" and "ibrutinib" refer to the sam...

A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic ...

Sep 17th, 2021 - The hypothesis is treatment with combination of I+VEN will result in longer PFS compared with G-Clb in participants with previously untreated chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) who meet International Workshop on CLL (iwCLL) treatment criteria. The study includes screening (30 days), treatment (from randomization until treatment discontinuation) and follow-up ph...

Baked Milk Oral Immunotherapy for Cow's Milk Allergy

Sep 17th, 2021 - This study is designed to assess the safety of baked milk oral immunotherapy among patients who are milk allergic and who do not pass a baked milk challenge.

Skin Rash Study Before Chemotherapy in Colorectal & Head and Neck Cancer Patients

Sep 17th, 2021 - Of the 100 subjects who will participate in this study, 50 will be in the extensive treatment group and 50 will be in the standard care group. Subjects in the extensive treatment group will use Doxycycline capsule, 100 mg, taken twice daily, sunscreen SPF 30 or higher, moisturizer applied to the face, hands, feet, neck, back, and chest each morning after sunscreen, hydrocortisone 1% cream appli...

Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

Sep 17th, 2021 - PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of the combinations of brentuximab vedotin and ipilimumab, brentuximab vedotin and nivolumab, and brentuximab vedotin, ipilimumab, and nivolumab. (Phase I) II. To evaluate the complete response (CR) rate for the regimens of brentuximab vedotin and nivolumab compared to brentuximab vedotin, ip...

A Phase I Study of iPS Cell Generation From Patients With COPD

Sep 17th, 2021 - As part of the long-term goal of successfully implementing tissue regeneration strategies in an individualized manner for patients with thoracic diseases including, but not limited to: cystic fibrosis, pulmonary fibrosis and pulmonary hypertension, the investigators will assess the feasibility of collecting skin biopsies from patients undergoing surgery for thoracic disease, culturing skin fibr...

Treatment of Multifocal Lung Adenocarcinoma

Sep 17th, 2021 - Lung bronchoalveolar carcinoma (BAC) or adenocarcinoma in situ (AIS) continues to represent a poorly understood clinical entity. A frequent clinical dilemma in lung cancer care is the management of a documented or suspected invasive adenocarcinoma in the setting of multifocal ground glass opacity (GGO) consistent with multifocal AIS. These patients are typically classified as stage IV disease, ...

A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants With Previously Treat...

Sep 17th, 2021 - This is a randomized (individuals assigned to study treatment by chance), double-blind (individuals and study personnel will not know the identity of study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study in approximately 400 adult participants with follicular lymphoma or marginal zone lymph...

Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure

Sep 17th, 2021 - The purpose of this study is to determine whether 60-minute sessions of prolonged exposure (PE) are as effective as the standard 90-minute session for treating posttraumatic stress disorder (PTSD). Participants will include patients ages 18 or older with a current diagnosis of PTSD who are seeking treatment in our clinic. Patients who have current substance dependence, psychosis, and suicidal i...

Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms

Sep 17th, 2021 - Background: Endocrine neoplasms are among the fastest growing tumors in incidence in the United States. Between 1995 and 2005, the incidence of thyroid carcinoma has increased 98 percent. Tumors of the thyroid, parathyroid, adrenal gland and gastrointestinal-pancreatic neuroendocrine tumors are among some of the most difficult tumors to clinically and histopathological distinguish as benign or ...

Study of Pharmacokinetics, Activity and Safety of Ruxolitinib in Pediatric Patients With Grade II-IV Acute Graft vs. Host Disease

Sep 17th, 2021 - The study is an open-label, single-arm, Phase I/II multi-center study to investigate the PK, activity and safety of ruxolitinib added to the patient's immunosuppressive regimen in infants, children, and adolescents ages ≥28 days to <18 years old with either grade II-IV aGvHD or grade II-IV SR-aGvHD. This trial will utilize four age groups: Group 1 includes patients ≥12y to <18y, Group 2 include...

Auris Robotic Endoscopy System for Bronchoscopy

Sep 17th, 2021 - The early and accurate diagnosis of lung cancer is critical. However, many peripheral lung lesions are beyond the reach of conventional bronchoscopes. Additionally, alternative techniques, such as CT-guided or surgical biopsy, can carry increased risks to the patient. Diagnostic yield of flexible bronchoscopy is limited by its inability to guide biopsy instruments directly to the lesion. Varyin...

Use of a Distal Colonoscope Attachment to Increase Detection of Sessile Serrated Adenomas

Sep 17th, 2021 - Colon cancer remains the second leading cause of death amongst both men and women in the United States(1). With the advent of screening colonoscopy, mortality from colorectal cancer has decreased, and colonoscopy is the current gold standard for colorectal cancer screening and prevention by removing adenomatous polyps. Different devices have been employed to assist the endoscopist in the detect...

Muscle-Tendon Mechanics During Locomotor Tasks, Efficacy of Collagen Supplementation for Older Adults

Sep 17th, 2021 - Being able to walk safely, to go up and down stairs and to recover from an unexpected gait perturbation are vital for older adults' autonomy, home maintenance and life quality. It is therefore of major interest to understand the mechanisms responsible for older adults (OA) decreased functional abilities. This study aims first to understand the links between muscles and tendons characteristics a...

Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)

Sep 17th, 2021 - Hyperphosphataemia is highly prevalent in patients with end-stage kidney disease (ESKD) and associated with increased mortality risk. The Clinical Practice Guidelines suggest lowering elevated phosphate levels towards the normal range (level 2C suggestion). However, trial data demonstrating that treatments that lower serum phosphate will improve patient-centred outcomes are lacking. The primary...

Daratumumab, Carfilzomib, Lenalidomide and Low Dose Dexamethasone (DKRd) in Newly Diagnosed, Multiple Myeloma

Sep 17th, 2021 - The purpose of this study is to determine response rate after 8 cycles of D-KRd (daratumumab, carfilzomib, lenalidomide (Revlimid) and dexamethasone in patients with multiple myeloma.

Staging Procedures to Diagnose Malignant Pleural Mesothelioma

Sep 17th, 2021 - The purpose of this study is to evaluate the accuracy of participants imaging versus staging procedures. The investigators will consent subjects that are scheduled to undergo staging procedures to diagnose malignant pleural mesothelioma (including pleuroscopy, bronchoscopy, endobronchial ultrasound and laparoscopy) as part of their standard of care.

Transitions Between Clinical Circulatory States After Out-of-hospital Cardiac Arrest

Sep 17th, 2021 - This study will obtain longitudinally advanced hemodynamic observations with high resolution during the acute phase of post cardiac arrest syndrome (PCAS), and analyze the details in clinical transitions related to circulatory failure. The study will also analyze the relationship between inflammatory biomarkers and circulatory failure in PCAS and kinetics of hemodynamics associated with standar...

Clinical Study of CMP-001 in Combination With Pembrolizumab or as a Monotherapy

Sep 17th, 2021 - The primary objective of Part 1 of the study is to determine the recommended Phase 2 dose (RP2D) and schedule of CMP-001 when given in combination with pembrolizumab in participants with advanced melanoma. The primary objective of Part 2 of the study is to assess and describe the safety profile of CMP-001 when administered as monotherapy. The primary objective of the Treatment Extension is to a...

Comparison of the Effectiveness of Three Teaching Methods in Oral Hygiene in Adolescent Orthodontic Patients

Sep 17th, 2021 - Patients applying for orthodontic treatment with braces in the orthodontic unit of the Rennes dental center will be offered to participate in the study. For each patient, the inclusion and non-inclusion criteria will be checked, and consent and a document explaining the course of the study will be delivered to them personally. The duration of the study will be 6 months for each of them. Each wi...

The Responses Study

Sep 17th, 2021 - The issue Patients who are living with a life-limiting and progressive illness are often encouraged by the healthcare professionals looking after them to undergo a process called Advance Care Planning (ACP). An advance care plan is a written guide of a patient's likes, dislikes, wishes, and the treatments they would want to refuse or the rituals they would want to follow - whether during illnes...

Simultaneous Assessment of FFR and SPECT

Sep 17th, 2021 - Patients who are previously scheduled for diagnostic coronary angiography will be approached for consent to be part of the study. If the patient is found to have one or two vessel disease and it is planned by the interventional cardiologist that FFR will be used, then the previously consented patient will be deemed appropriate for the study. The standard procedure will be followed for FFR testi...

Continuous Negative Abdominal Pressure in ARDS (CNAP in ARDS)

Sep 17th, 2021 - Adult respiratory distress syndrome (ARDS) is a serious pulmonary disease affecting adults and children. It has a high mortality and there is no specific therapy. The mortality is high (approx. 40% in severe cases) and this has not changed in the last 20 years. Mechanical ventilation is the mainstay of management, and this assists the patient by increasing oxygenation and removal of carbon diox...

Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)

Sep 17th, 2021 - The purpose of this study is to determine if tofacitinib is safe and effective in subjects with active ankylosing spondylitis.

First-in-human Study of BAY2287411 Injection, a Thorium-227 Labeled Antibody-chelator Conjugate, in Patients With Tumors Known to Express Mesothelin

Sep 17th, 2021 - The purpose of this study is to evaluate, in patients with tumors known to express the protein mesothelin, the following properties of BAY2287411 injection: safety (to identify, assess, minimize, and appropriately manage the risks associated to the study drug) tolerability (the degree to which side effects can be tolerated by your body) maximum tolerated dose pharmacokinetics (the effect of you...

Non-Complex Biliary Stones DSC vs ERC

Sep 17th, 2021 - The objective of this study is to prospectively compare non-complex biliary stone clearance using fluoroscopy/radiation-free direct solitary cholangioscopy (DSC) utilizing the SpyGlass™ system with non-complex biliary stone clearance using standard endoscopic retrograde cholangioscopy (ERC).

A Post-marketing Surveillance to Assess Safety of Abiraterone Acetate (Zytiga) in Indian Participants With Metastatic, Castration Resistant Prostate Cancer

Sep 17th, 2021 - This is a prospective (the participants are identified and then followed forward in time for the outcome of the study), multicenter (when more than one hospital or medical school team work on a medical research study), post-marketing surveillance ([PMS], surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale) study. The ...

The Safety,Efficacy of Anti-EGFR Humanized Monoclonal Antibody Combined With Chemotherapy in Advanced Solid Tumors.

Sep 17th, 2021 - This study is a parallel 3-arm escalation trial with 3 doses of HLX07 (400 mg, 600 mg, or 800 mg per single dose) combined with 3 different fixed-dose chemotherapy regimens. Three chemotherapy regimens are: ① Gemcitabine (1000 mg/m2) and Cisplatin (75 mg/m2) , every three weeks. Gemcitabine was administered on the first day and on the 8th day, and cisplatin 75 mg/m2 was administered on the fir...

Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer

Sep 17th, 2021 - This open label (all participants know the identity of the study drug), multicenter (more than one study site), first-in-human study consists of 2 parts. Part 1 is a Amivantamab Monotherapy and Combination Dose Escalations and Part 2 Amivantamab Monotherapy and Combination Dose Expansions. In Part 1, participants with evaluable NSCLC will be enrolled into cohorts at increasing dose levels of Am...

Combined Technology Enhanced Home Exercise Program and Other Non-pharmacological Intervention for Cancer Survivors

Sep 17th, 2021 - Home-based exercise interventions have a significant effect on fatigue; however, motivation and intervention compliance are the main challenges. The use of personalized exercise and immediate feedback though smartphome communication has been found to increase motivation. We developed a 12 weeks technology enhanced home exercise (TEHE) program using mobile technologies that provide immediate fee...

Point of Care Testing to Improve Monitoring of LVAD Patients

Sep 17th, 2021 - The purpose of this study is to develop and validate the accuracy of a low-cost "point-of-care" test (POCT) that allows monitoring of markers for anticoagulation and thrombosis (local coagulation or clotting of the blood), to be used by patients with advanced heart failure (AHF) on left ventricular assist device (LVAD) support. The investigators central hypothesis is that the fully-printed AT-P...

Exercise to Treat Frailty and Decreased Physical Function in Transplant Candidates

Sep 17th, 2021 - RECRUITMENT: This study will be conducted at Mayo Clinic in Rochester, MN. Patients over 18 who have chronic kidney disease will be approached for recruitment. Interested patients will go through the informed consent process and, if frailty testing was not completed within the two weeks prior to consent, patients will complete frailty testing. If patients are considered frail or pre-frail, they...

Bipolar Androgen Therapy +/- Carboplatin in mCRPC With/Without Homologous Recombination Deficiency

Sep 17th, 2021 - Androgen deprivation therapy (ADT) remains the mainstay of prostate cancer treatment. Though an effective therapy initially, the side effects of ADT are numerous and treatment resistance is inevitable. Castrate-refractory prostate cancer (CRPC) progresses via adaptive mechanisms that allow ongoing androgen receptor (AR) signalling despite castrate levels of androgens. The concept of cycling bet...

An Expanded Access Protocol for Apalutamide Treatment of Participants With Non-Metastatic Castration-Resistant Prostate Cancer

Sep 17th, 2021 - The purpose of this study is to collect additional safety data until apalutamide is commercially available for participants with non-metastatic castrate-resistant prostate cancer (NM-CRPC).

Neoantigen DNA Vaccine in Combination With Nivolumab/Ipilimumab and PROSTVAC in Metastatic Hormone-Sensitive Prostate Cancer

Sep 17th, 2021 - This study study aims to elucidate the immune responses to a shared antigen vaccine (PROSTVAC) and tumor specific antigens generated DNA vaccine in combination with checkpoint blockade using nivolumab (anti-PD-1), and ipilimumab (anti-CTLA-4). Additionally, the investigators will study the impact of the combination immunotherapy on peripheral T cell activation, as well as immune response in the...

Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4830-001)

Sep 17th, 2021 - This study has dose escalation (Part A, B, C) and dose expansion (Cohorts A-L) parts. Dose escalation is to evaluate the safety, tolerability, and preliminary efficacy of MK-4830 monotherapy administration (Parts A and B) and in combination with pembrolizumab (Part C). Dose expansion is to evaluate the objective response rate (ORR) of MK-4830 in combination with pembrolizumab and evaluate the s...

A Study to Test Radium-223 With Docetaxel in Patients With Prostate Cancer

Sep 17th, 2021 - The purpose of this study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone.

Phase 2b Study of KBP-5074 in Subjects With Uncontrolled Hypertension and Advanced Chronic Kidney Disease

Sep 17th, 2021 - The study will enroll up to 165 patients, randomized in a 1:1:1 ratio to 1 of 3 treatment groups (55 patients in each group): KBP-5074 0.25 mg once daily (QD), KBP-5074 0.5 mg QD, or placebo QD. Randomization will be stratified to balance enrollment for key variables that may influence safety and/or efficacy evaluations, including estimated Glomerular Filtration Rate (eGFR) (30 versus 29 mL/min...

Brain Amyloid- Retention During Wakefulness and Following Emergence From Sleep in Healthy People

Sep 17th, 2021 - Objective: To assess if there are differences in [18F]florbetaben uptake following the first 120 minutes of its injection (reflecting amyloid-beta or Ab load and/or docked Ab) in subjects during rested wakefulness (RW) after normal sleep compared to wakefulness after 24 hrs of sleep deprivation (SD). Specifically, we hypothesize that during RW after a normal night s sleep there will be less [18...

Chemotherapy Followed by Surgery and Neoadjuvant Hemothoracic Intensity Modified Radiation Therapy (IMRT) for Patients With Malignant Pleural Mesothelioma

Sep 17th, 2021 - The investigators will consent patients that have been diagnosed with mesothelioma and will undergo chemotherapy followed by surgery and then IMRT as their standard of care. The investigators will collect data from past and future medical records as well as data regarding their health status for their lifetime by reviewing life status, treatment status and CT scans.

Surgery for Mesothelioma After Radiation Therapy "SMART" for Resectable Malignant Pleural Mesothelioma

Sep 17th, 2021 - The purpose of this study is to determine whether radiation therapy decreases tumor size and tumor spread. The investigators will consent subjects that have been diagnosed with mesothelioma and will undergo radiation therapy followed by surgical resection as their standard of care. The investigators will collect data from past and future medical records as well as data regarding their health st...

Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin

Sep 17th, 2021 - PRIMARY OBJECTIVE: I. To determine the recommended phase 2 dose (RP2D) of M3814 (peposertib) when given in combination with intensity-modulated radiation therapy (IMRT). SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of the combination of M3814 (peposertib) with radiotherapy. II. To estimate the rates of grade 3 or greater acute toxicities of the regimen. III. To estimate late...

HygiRelief Procedure and HygiSample Evaluation for Functional Constipation

Sep 17th, 2021 - After undergoing a 5-7 day Linzess washout period, patients will record their bowel habits in a daily diary for 2 weeks. Patients will have the HygiRelief procedure with a HygiSample evaluation, then they will record their bowel habits in a daily diary for 2 weeks following the HygiRelief procedure. HygiSamples (stool samples) will be collected throughout the HygiRelief procedure and the sample...

Phase II Randomized Trial of Bethesda Protocol Compared to Cambridge Method for Detection of Early Stage Gastric Cancer in CDH1 Mutation Carriers

Sep 17th, 2021 - Background: Hereditary Diffuse Gastric Cancer (HDGC) is most often attributed to inactivating germline mutations in the E-cadherin (CDH1) tumor suppressor gene. Mutation carriers have a 24-70% lifetime risk of developing gastric adenocarcinoma. International consensus guidelines recommend endoscopic screening and surveillance of CDH1 mutation carriers who decline risk-reducing total gastrectomy...

A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator

Sep 17th, 2021 - After screening, participants will be randomized to ASP3772 or PCV13 on Day 1. A single dose of ASP3772 will be administered on Day 1 as an injection into the right or left thigh muscle at one of three dose levels. The participants randomized to PCV13 will receive a single intramuscular injection of the approved dose of PCV13 into the right or left thigh muscle. All participants will remain at ...

A Pharmacokinetic Study of Sugammadex in Dialysis Patients

Sep 17th, 2021 - Patients with end-stage renal disease often have several additional comorbidities and stand to benefit immensely from this established superior drug. Prior studies have not been able to correlate negative adverse events with sugammadex in patients with end-stage renal disease. More work needs to be done, however, to assess the fate of this renally excreted molecule. It has been shown that there...

Non-Invasive Vagal Nerve Stimulation in Opioid Use Disorders

Sep 17th, 2021 - Subjects in this study will be patients with opioid use disorders (OUDs) based on DSM-5 criteria recruited from the greater Atlanta metropolitan region. The metropolitan Atlanta area has about 2,623,744 persons age 12 or older. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), 109,777 (4.18%) have non-medical use of prescription pain relievers, and 48,302 are ...

A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Prostate-Specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Positive Hormone-Sensitive Prost...

Sep 17th, 2021 - Prostate cancer is currently the fifth leading cause of cancer deaths among men globally, with 1 million diagnosed per year and mortality burden of over 300,000 deaths. The hypothesis of study is addition of apalutamide to RT+ LHRHa provides superior efficacy in terms of PSMA-PET metastatic progression-free survival-ppMPFS. Apalutamide is a non-steroidal androgen receptor (AR) antagonist being ...

A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)

Sep 17th, 2021 - A 2-part study, comprising of a 36-week placebo-controlled period and a 24-week open-label extension period, to assess the efficacy and safety of 2 dose regimens of GB004 when added to background UC therapy of 5-aminosalicylate (5-ASA) with or without systemic steroids.

To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)

Sep 17th, 2021 - Prospective participants must be on stable doses of ruxolitinib ranging from 5 mg BID to 25 mg BID and will have been on that dose for at least the last 8 weeks prior to Day 1. At least 3 months duration of prior ruxolitinib is required. Participants must meet Protocol-defined criteria for suboptimal response to ruxolitinib monotherapy. After participants have been determined to be eligible for...

To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)

Sep 17th, 2021 - This is a Phase 3, randomized, double-blind study of the combination of the PI3Kδ inhibitor parsaclisib or matching placebo and the JAK1/2 inhibitor ruxolitinib in participants with PMF or secondary MF (PPV-MF or PET-MF) with DIPSS risk category of intermediate or high. Prospective participants must have not received prior MF therapy with a JAK inhibitor or a PI3K inhibitor. After participants ...

A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Participants With Primary Progressive Multiple Sclerosis

Sep 17th, 2021 - A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (or placebo) or intravenous (IV) ocrelizumab (or placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). Approxima...

Anti-BK Virus Immune Response and Kidney Transplantation

Sep 17th, 2021 - BK virus infections are very frequent during months following a kidney transplantation: a viral reactivation is observed for almost 50% of patients during first year. This reactivation leads to a viremia for 10 to 15% of patient during this same period. The most frequent complication is interstitial nephritis for 2 to 8% of patients (27 patients representing 2.7% during 6 years in Nantes). An i...

NKI Therapy Compared to Usual Care of Recurrent Esophagogastric Anastomotic Strictures

Sep 17th, 2021 - Rationale: The study hypothesizes that NKI followed by endoscopic bougie dilation therapy will result in an increased dysphagia-free period, a reduction of endoscopic procedures and dysphagia-related quality of life, and lower costs, when compared with the standard endoscopic bougie dilation (EBD) in recurrent esophagogastric anastomotic strictures. Objective: To evaluate the efficacy and cost-...

VRC 900: Evaluation of Tissue-Specific Immune Responses in Adults 18 Years of Age and Older

Sep 17th, 2021 - Protocol Design: This is a specimen, imaging and data collection protocol designed with the purpose of understanding the immune responses to vaccines and infections in adult subjects through collection of tissue specimens and medical history data, and radiographic imaging. The information gained will enhance the knowledge of immune correlates of protection and will help in laboratory work relat...

Defining the Brain Phenotype of Children With Williams Syndrome

Sep 17th, 2021 - Williams syndrome (WS) is a rare disorder caused by hemizygous microdeletion of approximately 1.6 megabases on chromosomal band 7q11.23, typically by spontaneous mutation. The disorder is characterized by a collection of unique neuropsychiatric manifestations, including marked visuospatial construction deficits and hypersociability. Because the genes involved in WS are known, the study of neura...

Intranasal Injection of PRP Versus Saline for Treatment of Olfactory Dysfunction

Sep 17th, 2021 - Olfactory dysfunction constitutes a common impairment in the general population, affecting nearly 20 million in the USA and severely impairing quality of life. Unfortunately, this problem is often permanent, and no effective treatment is available at this time. Although many etiologies exist for olfactory loss, the underlying pathology is thought to be permanent damage to the olfactory bulb, ne...

Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products

Sep 17th, 2021 - All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.

Intergenerational Effects of Paternal Periconceptional Cannabis and Other Drug Use (EPIC)

Sep 17th, 2021 - This project involves enrollment of 40 healthy mother-father dyads that are between the ages of 18 and 40 years. Urine samples for qualitative drug and cotinine testing will be collected from mother-father dyads, as well as quantitative THC (tetrahydrocannabinol) and THCCOOH (11-nor-9-carboxy-THC) assay. A semen sample will be collected from biological fathers. Relevant birth outcome data inclu...

Anxiety Intervention for Preschool Children With ASD

Sep 17th, 2021 - Anxiety is highly prevalent in individuals with ASD with lifelong impact. In this population, anxiety often emerges when children are very young, yet there are no evidence-based treatments for this age group. Cognitive-behavioral treatment (CBT) successfully reduces anxiety levels in young, typically developing children and older children with ASD. This study pilots the DINO Strategies for Anxi...

A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer

Sep 17th, 2021 - This is an open-label, single-arm, phase II, multicenter study designed to evaluated the efficacy and safety of atezolizumab in combination with bevacizumab in PD-L1-selected patients with Stage IIIB-IV Non-Squamous NSCLC harbored EGFR mutation after EGFR TKI therapy.

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by ...

Sep 17th, 2021 - Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer (almost 20 percent [%] of cancer deaths); NSCLC accounts for 80% to 85% of lung cancers. Amivantamab (JNJ-61186372) is a low fucose, fully human immunoglobulin G1 (IgG1)-based bispecific antibody directed against epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (M...

The Benchmark Clinic: An Interdisciplinary Comprehensive Care Model for People With Parkinson Disease

Sep 17th, 2021 - The purpose of this study is to determine if an interdisciplinary clinic can help people with Parkinson's disease care for themselves, improve their ability to follow recommended treatments, and have fewer problems like falls or visits to the emergency room. Participants will be randomly assigned to receive either care from the interdisciplinary clinic or standard neurological specialist care. ...

Identification and Validation of Biomarkers for Breast Cancer Resistance Protein (BCRP)

Sep 17th, 2021 - Membrane transporters are critical in the absorption, distribution and elimination of drugs, and are important target sites for drug-drug interactions (DDIs). During drug development, clinical studies characterizing transporter-mediated DDIs are frequently required. There has been enormous interest in identifying and validating serum biomarkers or surrogate probes to be used in predicting in vi...

Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations

Sep 17th, 2021 - PRIMARY OBJECTIVE: I. To evaluate the progression free survival (PFS) of advanced pancreatic cancer patients with germline BRCA1 or BRCA2 mutations treated with olaparib + pembrolizumab compared to olaparib alone as maintenance therapy. SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability associated with the combination of olaparib + pembrolizumab versus (vs.) olaparib alone as main...

A Natural History Study to Evaluate Functional and Anatomical Progression in Retinitis Pigmentosa

Sep 17th, 2021 - This study will assess the progression of RP as seen on newer modalities including spectral-domain optical coherence (SD-OCT) and macular assessment integrity (MAIA) microperimetry to evaluate disease status. Understanding the natural history of the disease is not only essential to monitoring and comparing patient populations in clinical trials. It is also fundamental in the predevelopment phas...

A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes

Sep 17th, 2021 - This study is done to see if semaglutide has an effect on walking ability compared with placebo (dummy medicine) in people with peripheral arterial disease (PAD) and type 2 diabetes. Participants will either get semaglutide or placebo ("dummy") medicine - which treatment participants get is decided by chance. Semaglutide is a medicine for type 2 diabetes that can be prescribed by doctors in som...

Low Dose Daunorubicin in Pediatric Relapsed/Refractory Acute Leukemia

Sep 17th, 2021 - Cancer remains the number one cause of non-accidental death in children with leukemia being the most common type of childhood cancer. Although cure rates for pediatric leukemia have greatly improved over the last few years, relapsed disease still carries a poor prognosis. Outcomes for children with multiply relapsed leukemia are dismal ranging from a remission rate of 25% in AML after 2 relapse...

Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers

Sep 17th, 2021 - This is a study evaluating the safety and efficacy of Lattice SBRT for patients with large tumors (≥ 4.5 cm) planning to undergo palliative radiotherapy.

A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013)

Sep 17th, 2021 - This study will compare the efficacy and safety of two doses of belzutifan in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that the higher dose of belzutifan is superior to the standard dose in terms of objective response rate (ORR).

Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery

Sep 17th, 2021 - Subjects who can not be randomized due to any reason will be enrolled at observational group.

The Objective of This Study is to Compare the Efficacy and Safety of Beremagene Geperpavec (B-VEC) Topical Gel With That of Placebo for the Treatment of Dystrophic Epidermolysis Bullosa (DEB).

Sep 17th, 2021 - Thirty-one (31) participants with DEB, aged 6 months or older at time of consent are planned for this Phase III study. The trial duration for each subject is about 6 months, with administration occurring once weekly. A Safety Follow-up Visit occurring 30 days from the date of final treatment with the Investigational Product will also occur. Each subject provides at least one pair of primary tar...

A Study of ALG-010133 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects

Sep 17th, 2021 - A Randomized Study of ALG-010133 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects

Virtual Exercise for Multiple Myeloma

Sep 17th, 2021 - Multiple myeloma (MM), a cancer of the plasma cells in bone marrow, is associated with osteolytic bone destruction, leading to deformities, chronic pain, reduced mobility and functioning, fatigue, and risk of fracture. Although incurable, newly developed therapies are extending survival, but some with significant side-effects. Patients may be living longer but with lasting, debilitating side-ef...

Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)

Sep 17th, 2021 - The iATP PAS is a global, prospective, observational, multi-site registry study. Patients enrolled in the iATP PAS will be prospectively followed in the registry until registry closure, patient death, or patient exit from the registry (i.e., withdrawal of consent). Patient and device status will be assessed at least annually or as prompted by reportable adverse events. Remote device data transm...

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologo...

Sep 17th, 2021 - Prostate cancer is a heterogenous disease and recent genomic analyses have highlighted specific germline and somatic mutations and alternative driver growth signaling pathways in patients with metastatic disease. Abiraterone acetate plus prednisone (AA-P) is an established standard of care for the treatment of participants with mCSPC and is included in widely accepted clinical treatment guideli...

Perioperative Vitamin C Lung Transplant

Sep 17th, 2021 - PGD is a frequent and severe outcome that impacts both short- and long-term outcomes after lung transplantation. Major pathophysiologic contributors include ischemia and reperfusion injury, mitochondrial dysfunction and endothelial failure. No directed therapy exists. Vitamin C is a first-line antioxidant that also acts at the endothelium and mitochondria to decrease permeability and leak, inhi...

A Study of Atezolizumab (Tecentriq) in Combination With Bevacizumab to Investigate Safety and Efficacy in Patients With Unresectable Hepatocellular Carcinoma Not Previously Treated With Systemic Th...

Sep 17th, 2021 - This is a Phase IIIb, one arm, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab + bevacizumab in patients with unresectable HCC who have received no prior systemic treatment.

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Sep 17th, 2021 - Worldwide, lung cancer is the most commonly diagnosed cancer. In NSCLC the most prevalent actionable driver mutations result in the activation of epidermal growth factor receptor (EGFR). Osimertinib and Lazertinib are EGFR tyrosine kinase inhibitors (TKIs). Amivantamab is a novel bispecific antibody that targets the extracellular domain of both EGFR and MET and can inhibit tumor growth driven b...

Clinical Trial to Decrease Length of Stay in Infants With Neonatal Abstinence Syndrome With an Exclusive Human Milk Diet

Sep 17th, 2021 - This is a single blinded (physician investigator), randomized, controlled trial to evaluate length of stay in infants with NAS and an exclusive human milk diet during their initial hospitalization after birth and through the 28 days of life or hospital discharge, whichever comes first. Subjects will be randomized to one of two groups after at birth. Parents who decline participation for their i...

Sense of Control in Frail Older Persons

Sep 17th, 2021 - The proposed study seeks to explore the lived experience of control and wellbeing of older people diagnosed with frailty within the care service provision in southern England. In the study, the researcher will talk with older people diagnosed with frailty and the professionals that provide care to them. The researcher is interested in understanding participants' experiences of a sense of contro...

An Evaluation of Insomnia Treatment to Reduce Cardiovascular Risk in Patients With Posttraumatic Stress Disorder

Sep 17th, 2021 - Posttraumatic stress disorder (PTSD) is a disabling and costly psychiatric disorder that is estimated to occur in 20% of individuals who are exposed to a traumatic event and is chronic in one third of cases. In addition to its negative impact on quality of life, there is substantial evidence that PTSD (even after controlling for depression and other risk factors) is associated with a markedly i...

GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

Sep 17th, 2021 - The primary objective for this trial is to determine the effect of GB002 (seralutinib) on improving pulmonary hemodynamics in subjects with World Health Organization (WHO) Group 1 PAH who are Functional Class (FC) II and III. The secondary objective for this trial is to determine the effect of GB002 (seralutinib) on improving exercise capacity in this population.

Goal Management Training in Individuals With PTSD

Sep 17th, 2021 - PTSD has an emotional impact on individuals, but it is also associated with impaired cognitive functioning (e.g., processing speed, attention, executive functioning). This study is an effectiveness trial investigating a cognitive remediation intervention (Goal Management Training, or GMT) that has been shown to improve the cognitive impairment observed in other populations (e.g., older adults)....

Bone Conduction Implant and MRI

Sep 17th, 2021 - The patients included in the study will all have a cerebral MRI as part of the cholesteatoma follow-up or for the assessment of cerebral or inner ear pathology. ENT evaluation: The position of the implant will be evaluated. The distance from the external ear canal (center of the abutment or center of the magnet) will be measured on the patient using a ribbon meter. The angle between the implant...

Precise High Resolution MRI to Increase Accuracy and Gain Confidence to Diagnose Patients With Optic Disc Edema

Sep 17th, 2021 - The presence of optic disc swelling at the fundus is a non-specific clinical sign that can occur in many ophthalmologic, neuro-ophthalmologic or encephalic pathologies. The diagnostic range is vast, including inflammatory pathologies of the optic nerve, infiltrative or compressive orbital pathologies, idiopathic or secondary intracranial hypertensions, not to mention the pseudo optic disc swell...

Impact of Once-Weekly Rifapentine and Isoniazid on the Steady State Pharmacokinetics of Dolutegravir and Darunavir Boosted With Cobicistat in Healthy Volunteers

Sep 17th, 2021 - Rifapentine (RPT) is a long-acting rifamycin that can be used weekly with isoniazid (INH) as a first-line regimen in the treatment of latent tuberculosis infection (LTBI). Although this regimen offers several potential benefits, the use of weekly RPT plus INH is not currently recommended in adults infected with human immunodeficiency virus (HIV) on antiretroviral therapy (ART) due to limited ev...

Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC

Sep 17th, 2021 - The primary objective of this study is to evaluate the efficacy of cabozantinib (XL184) in combination with atezolizumab versus a second NHT (abiraterone or enzalutamide) in subjects with mCRPC who have previously been treated with one, and only one, NHT (e.g. abiraterone, apalutamide, darolutamide, or enzalutamide) to treat metastatic castration-sensitive prostate cancer (mCSPC), non-metastati...

Phase II Study of Pembrolizumab and Nab-paclitaxel in HER-2 Negative Metastatic Breast Cancer

Sep 17th, 2021 - This is a single-arm open-label multi-cohort Phase II study evaluating the safety/tolerability and clinical activity of the combination of nab-paclitaxel and the antibody against programmed cell death 1 (PD-1), pembrolizumab, in patients with human epidermal growth factor receptor (HER-2) negative metastatic breast cancer (n=50). There will be two cohorts of patients consisting of a triple nega...

Managing Pain and Symptom Burden Caused by Chemotherapy in People With Myeloma or Lymphoma

Sep 17th, 2021 - The purpose of this study is to find out whether acupuncture treatments can reduce the need for opioid medication when managing pain caused by chemotherapy. The study will compare the effects of adding acupuncture to usual pain management with those of usual pain management alone, in reducing opioid use by relieving pain. Researchers also want to find out more about the effects of acupuncture t...

Monotherapy IVIG Gamunex-C for HMG-CoA Reductase Auto-Antibody Positive Necrotizing Myopathy Treatment (The MIGHT Trial)

Sep 17th, 2021 - This is a phase 2, double-blinded, randomized, placebo-controlled, multi-center trial of Gamunex-C IVIG as mono-therapy for HMGCR necrotizing myopathy. Up to 10 treatment-naïve patients will be enrolled and randomized to receive either Gamunex-C IVIG dosed at 2g/kg or placebo at week 0 and week 4. The primary efficacy outcome is the percentage of patients at week 8 with at least minimal improve...

Diagnostic Accuracy of Optimized Diffusion-Weighted Imaging for Detecting Anterior Ischemic Optic Neuropathy

Sep 17th, 2021 - The patient presents to the ophthalmological emergencies and / or to the internal medicine department. NOIA clinical discovery Patient referred in radiology for brain and visual MRI. The two sequences added by the research (8 minutes) will be added to that of the treatment.