pankajrajdeo/Clinical_Trials · Datasets at Hugging Face

NCT00926887

Low Level Laser Therapy to Reduce Pain After Breast Augmentation Surgery

https://clinicaltrials.gov/study/NCT00926887

null

COMPLETED

The goal of the clinical study was to see if applying low level laser light therapy to the breasts during breast implant surgery could lessen pain experienced by 24 hours after the surgery.

YES

Pain

DEVICE: Erchonia(R) EML Laser|DEVICE: Placebo Laser

Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative., Self-reported Degree of Pain rating using the standardized 0-100 Visual Analog Scale (VAS) scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. The VAS ratings range from 0 to 100, where 0 represents no pain at all and 100 represents worst pain imaginable. A VAS of 30 is indicated as a cutoff threshold for success. Participants who recorded a VAS rating of less than 30 were considered study successes and are reported below., 24 hours post-operative|Self-reported Pain Rating on the 0-100 VAS 24 Hours Post-operative., Self-reported Degree of Pain rating using the standardized 0-100 VAS scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. VAS values range from 0 representing no pain at all to 100 representing worst pain imaginable., 24 hours

Swelling Evaluation Through Length by Width Breast Diameter Measurements, immediately, 24 hours & 7 days post surgery|Self-reported Degree of Pain Rating in the Breasts Area., 24 hours, 7 days, 14 days & 28 days post surgery|Use of Pain Management Medication Post-surgically., Average number of rescue pain medication doses consumed across the 1st 7 post-operative days., Through the 1st 7 post-operative days.|Hydration Level Assessment, immediately, 24 hours & 7 days post surgery.|Infection Evaluation, 24 hours & 7 days post surgery|Wound Healing Evaluation According to the Modified Hollander Cosmesis Scale, 7 days post surgery

null

Erchonia Corporation

null

FEMALE

ADULT

null

104

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

EBA-001

2005-09

2007-07

2009-06-24

2011-07-06

2014-04-17

null

{ "Erchonia(R) EML Laser": [ { "intervention_type": "DEVICE" } ], "Placebo Laser": [ { "intervention_type": "DEVICE" } ] }

NCT03268187

Biofeedback-based Relaxation Training or Self-alert Training to Alleviate Fatigue in Multiple Sclerosis Patients.

https://clinicaltrials.gov/study/NCT03268187

null

COMPLETED

The presented study compares the effectiveness of a biofeedback-based relaxation training with the effectiveness of a biofeedback-based self-alert training on the reduction of fatigue in multiple sclerosis patients using a between groups design. Furthermore, the relation of fatigue in multiple sclerosis patients and autonomic potentials as well as the performance in a vigilance task will be examined. The relaxation training is based on the principle of progressive muscle relaxation according to Jacobsen. The patient is asked to tense all muscles in their face and perceive consciously the relaxation afterwards according to verbal cues. In the self-alert training condition, the patient will hear verbal cues to increase their attention. In both conditions the external cues given will be reduced in four phases until the patient has to cue himself. The patient is advised to track the changes in the skin resistance mirrored by biofeedback on a screen. In both conditions the training will be split on two days. During the whole examination heart rate and skin resistance will be recorded. The allocation to the training happens randomly. On the first day the patient will complete questionnaires to survey depression and apathy and do a baseline vigilance task. Before and after the vigilance task the current fatigue status will be assessed using a visual analogue scale. Afterwards an introduction in the treatment method will be given. On the second day the introduction into the training will be repeated. Afterwards a short time vigilance task will be done and questionnaires to survey fatigue and sleep behaviour and quality will be completed. Subsequently the last part of the training (no external cues) will be done. The examination will be completed by a long-time vigilance task. Before and after the vigilance task the current fatigue status will be assessed using a visual analogue scale. It is hypothesised that especially the biofeedback-based self-alert training has a positive effect on fatigue and the vigilance performance in multiple sclerosis patients, as it increases the ectodermal activity and increases the sympathetic activation. It was shown that phasic changes of the skin resistance are correlated with an increase of neuronal activity in the brain areas relevant for vigilance (Critchley et al., 2002; Nagai et al., 2004). The relaxation training will reduce the sympatho-adrenergic excitation disposition and reduce the level of activity. Consequently, we do not expect an alleviation of the perceived fatigue according to our underlying model (Hanken et al., 2016). In addition, it is hypothesized that, independent from the treatment, autonomic potentials correlate with fatigue.

NO

Fatigue|Multiple Sclerosis

DEVICE: Biofeedback|BEHAVIORAL: Self-Alert Training|BEHAVIORAL: Relaxation Training

Reaction Time of Vigilance Task (TAP), Changes of the reaction time in the vigilance task, Vigilance is measured at the beginning of the first day before the training introduction as well as after the training at the second day.|Subjective Fatigue (VAS), The current perceived fatigue, Before and after the long-term vigilance tasks at day 1 and 2

Omissions and errors of Vigilance Task (TAP), The number of omissions and errors made in the Vigilance Task, At day one before the introduction in the training and at day two after the training.

null

Rehazentrum Wilhelmshaven

null

ALL

CHILD, ADULT, OLDER_ADULT

null

61

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

009/2017

2017-07-17

2018-06-09

2018-10-18

2017-08-31

null

2019-04-11

Rehazentrum Wilhelmshaven, Wilhelmshaven, Lower Saxony, 26382, Germany

null

{ "Biofeedback": [ { "intervention_type": "DEVICE" } ], "Self-Alert Training": [ { "intervention_type": "BEHAVIORAL" } ], "Relaxation Training": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT03724487

A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement

https://clinicaltrials.gov/study/NCT03724487

Coachman

COMPLETED

The prevalence of hypertension among U.S. adults increased from 32% to 46% and African Americans are disproportionately impacted. Self-managing hypertension presents challenges such as dealing with complex treatment regimen, including critical components of recommended hypertension treatment such as self-blood pressure monitoring, and lifestyle modifications involving diet, exercise, and tobacco cessation. African Americans with hypertension have lower adherence to self-management behavior due to multifactorial reasons. Substantial evidence has demonstrated the important role of community support in improving patients self-management of a variety of chronic illnesses, though integrating technology in such programs are rarely offered. The purpose of this study is to investigate the effectiveness of a community outreach program using a technology-based intervention (TBI) to support self-managing hypertension (called COACHMAN) to improve BP control.

YES

Hypertension|Self-management|Technology|Community-based Participatory Research

BEHAVIORAL: Coachman|BEHAVIORAL: Enhanced Usual Care (EUC)

Change in Systolic and Diastolic Blood Pressure, The primary outcome was a change (reduction) in both the systolic and diastolic blood pressure from baseline to 12 weeks, in which the 12 weeks mean systolic minus the baseline systolic were calculated. The same for 12 week diastolic BP minus the baseline diastolic BP were calculated for a mean change score. The change score (number) can range from no change (0) to a 10 point reduction in blood pressure., baseline and 12 weeks|Change in PROMIS Global Health-10 [Health-related Quality of Life], Change in PROMIS Global Health-10 score (two subscales- Mental and Physical Health) from baseline to 12 weeks. Raw scores range from 4-20, higher scores represent better health. The change score is calculated as a mean difference between the two scores: at baseline and at 12 weeks. Scores are reported as a change value number, on a continuous number scale, that can be negative or positive (0 to 1, higher number better health)., Baseline and 12-weeks

Achieved Blood Pressure Target of < 130/80 mm Hg at 12 Weeks, Achieved Blood Pressure target is defined as the rate of participants that have a blood pressure of at the end of 12 weeks, < 130 mm Hg for systolic blood pressure and <80 mmHg diastolic blood pressure, in the intervention group. Percentage of individuals that achieved blood pressure target can range from 0 -100%, 12 weeks

null

Case Western Reserve University

University Hospitals Cleveland Medical Center

ALL

ADULT, OLDER_ADULT

null

60

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE

5U54MD002265-12

2019-03-01

2019-11-30

2020-05-01

2018-10-30

2022-06-09

2022-08-16

Case Western Reserve University, Cleveland, Ohio, 44143, United States

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT03724487/Prot_SAP_000.pdf

{ "Coachman": [ { "intervention_type": "BEHAVIORAL" } ], "Enhanced Usual Care (EUC)": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT04249687

Treatment of Moderate to Severe Lateral Canthal Lines

https://clinicaltrials.gov/study/NCT04249687

READY-2

COMPLETED

The objective of the study is to evaluate the efficacy and safety of a single dose of QM1114-DP compared to placebo for the treatment of moderate to severe LCL.

YES

Lateral Canthal Lines

BIOLOGICAL: botulinum toxin|BIOLOGICAL: Placebo

Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Line Investigator and Subject Assessments at Maximum Smile at One Month., The investigator and subject evaluate the subjects LCL severity using a 4-grade scale (0 = none and 3 = severe), Month 1

Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile., One Month

null

Galderma R&D

null

ALL

ADULT, OLDER_ADULT

PHASE3

303

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

43QM1901

2020-02-10

2020-09-25

2021-02-10

2020-01-31

2023-06-18

Ablon Skin Institute and Research Center, Manhattan Beach, California, 90266, United States|Dermatology Cosmetic Laser Medical Associates, San Diego, California, 92121, United States|Art of Skin, MD, Solana Beach, California, 92075, United States|Siperstein Dermatology Group, PLLC, Boynton Beach, Florida, 33472, United States|Facial Plastic Surgicenter, Ltd, Baltimore, Maryland, 21208, United States|The Center for Dermatology, Cosmetic & Laser Surgery, Mount Kisco, New York, 10549, United States|Rochester Dermatologic Surgery, Ltd, Victor, New York, 14564, United States|Aesthetic Solutions, PA, Chapel Hill, North Carolina, 27517, United States|Dr. Shannon Humphrey, Inc, Vancouver, British Columbia, V5Z 4E1, Canada|Pacific Dermaesthetics, Inc, Vancouver, British Columbia, V6H-4E1, Canada

Study Protocol, https://cdn.clinicaltrials.gov/large-docs/87/NCT04249687/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT04249687/SAP_001.pdf

{ "Botulinum toxin": [ { "intervention_type": "BIOLOGICAL", "description": "botulinum toxin", "name": "Botulinum toxin", "synonyms": [ "Myobloc", "Botox", "Botulinum toxin", "Jeuveau" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Botulinum%20toxin", "generic_names": [] } ], "Placebo": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT02846987

Study of Abemaciclib in Dedifferentiated Liposarcoma

https://clinicaltrials.gov/study/NCT02846987

null

ACTIVE_NOT_RECRUITING

The purpose of this study is to test any good and bad effects of the study drug called Abemaciclib. Abemaciclib could shrink your cancer but it could also cause side effects. Researchers hope to learn if the study drug will delay the growth of the cancer or shrink the cancer by at least one quarter compared to its present size. Abemaciclib is not FDA approved and has not been tested in liposarcoma, but it has shrunk tumors in patients with breast cancer, lymphoma, and lung cancer.

NO

Sarcoma|Dedifferentiated Liposarcoma

DRUG: Abemaciclib

progression-free, Progression includes both disease progression (as defined by RECIST 1.1) and death from any cause., 12 weeks

null

Memorial Sloan Kettering Cancer Center

Eli Lilly and Company

ALL

ADULT, OLDER_ADULT

PHASE2

33

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

16-376

2016-07

2024-07

2016-07-27

null

2023-12-28

Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States

null

{ "Abemaciclib": [ { "intervention_type": "DRUG", "description": "Abemaciclib", "name": "Abemaciclib", "synonyms": [ "Abemaciclib", "Ramiven", "Zenlistik", "Verzenio", "Verzenios" ], "medline_plus_id": "a617049", "generic_names": [ "Abemaciclib" ], "drugbank_id": "DB12001", "wikipedia_url": "https://en.wikipedia.org/wiki/Abemaciclib" } ] }

NCT02004587

Influence of Hepatic Impairment on Pharmacokinetic (PK) and Pharmacodynamic (PD) of Gemigliptin PK and PD After Multiple Oral Doses in Healthy White Volunteers

https://clinicaltrials.gov/study/NCT02004587

null

COMPLETED

The trial will investigate the influence of hepatic function on the PK of gemigliptin. In an additional treatment period, the PK and safety of multiple dosing of gemigliptin in healthy White subjects will be investigated.

NO

Hepatic Impairment

DRUG: Gemigliptin

AUC, Blood samples will be prepared at planed points., Several time points until 72hr

null

LG Life Sciences

null

ALL

ADULT, OLDER_ADULT

PHASE1

28

INDUSTRY

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

LG-DPCL014

2013-09

2014-05

2014-07

2013-12-09

null

2014-07-14

CRS Clinical Research Services, Kiel, Schleswig-Holstein, 24105, Germany

null

{ "Gemigliptin": [ { "intervention_type": "DRUG", "description": "Gemigliptin", "name": "Gemigliptin", "synonyms": [ "", "Gemigliptin" ], "drugbank_id": "DB12412", "generic_names": [ "Gemigliptin" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Gemigliptin" } ] }

NCT05190887

What do Patients Expect After Scaphoid Fractures?

https://clinicaltrials.gov/study/NCT05190887

null

UNKNOWN

This study will assess patients expectations pre-op and assess their views on their outcome at one year follow up

NO

Expectations

null

Patient expectations after scaphoid fractures, Trauma Expectation Factor (TEF) questionnaire will be used at the time of injury - followed by the Trauma Outcome Measure (TOM) questionnaire at 1 - year post injury. - Together = TEFTOM. A higher TEF score indicates higher expectations of recovery, while a lower indicated poor expectations. Discrepancy between the two scores demonstrate poor correlation between what the patient expects and what the outcome is., 1 Year

null

Kuwait Institute for Medical Specialization

null

ALL

ADULT, OLDER_ADULT

null

100

OTHER_GOV

OBSERVATIONAL

Observational Model: |Time Perspective: p

KuwaitIMS

2021-04-01

2022-04

2022-01-13

null

2022-01-13

AlRazi Orthopedic Hospital, Kuwait City, 00000, Kuwait

null

{}

NCT02233387

PET CT With HX4 in Cervix Cancer

https://clinicaltrials.gov/study/NCT02233387

HX4-cervix

TERMINATED

The aim of this study is: 1. to determine if tumor hypoxia can be accurately visualised with [18F]HX4 PET imaging in cervix cancer, 2. to correlate the [18F]HX4 PET images with blood and tissue markers, 3. to investigate the quality and optimal timing of [18F]HX4 PET images, 4. to compare [18F]HX4 PET uptake with [18F]FDG PET uptake before and after treatment and 5. analyze correlation with responses

NO

Cervix Cancer

OTHER: injection with [18F] HX4 and PET imaging

Visualisation of tumor hypoxia with [18F] HX4 PET imaging, Visualisation of tumor hypoxia with [18F] HX4 PET imaging, 2 year

Observation of spatial and temporal stability of [18F] HX4 PET images, Observation of spatial and temporal stability of [18F] HX4 PET images, 2 year|Correlations with Complete Remission rates at 3 months restaging evaluation, Correlations with Complete Remission rates at 3 months restaging evaluation, 2 year|Image quality of [18F] HX4-PET at different time points, Image quality of [18F] HX4-PET at different time points, 2 year|Kinetic analysis of HX4, Kinetic analysis of HX4, 2 year|Correlation of hypoxia imaging with blood hypoxia markers (osteopontin, circulating CA-IX), Correlation of hypoxia imaging with blood hypoxia markers (osteopontin, circulating CA-IX), 2 year|Correlation of hypoxia imaging with tumor tissue biomarkers (HPV, CA-IX, VEGF, EGFR, CD44, HIF-1α, mir-210) and autophagy related genes, Correlation of hypoxia imaging with tumor tissue biomarkers (HPV, CA-IX, VEGF, EGFR, CD44, HIF-1α, mir-210) and autophagy related genes, 2 year|Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment, Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment, 2 year|Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment, Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment, 2 year

null

Maastricht Radiation Oncology

null

FEMALE

ADULT, OLDER_ADULT

PHASE2

4

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC

11-36-14/12

2014-11

2018-05

2014-09-08

null

2019-03-08

MAASTRO clinic, Maastricht, 6229 ET, Netherlands

null

{ "injection with [18F] HX4 and PET imaging": [ { "intervention_type": "OTHER" } ] }

NCT03519087

Nonarthritic Hip Disease Evaluation And Treatment

https://clinicaltrials.gov/study/NCT03519087

NEAT

TERMINATED

The investigators aim to understand how interdisciplinary care influences decisions, expectations, and outcomes for patients with non-arthritic hip disease (NAHD). Patients presenting to the Ohio State University Wexner Medical Center (OSUWMC) Hip Preservation Clinic will be approached for participation. All participants will proceed with their scheduled, standard-care physician evaluation. Participants without NAHD will be excluded. Participants will then be randomized to receive a same-day physical therapist (PT) evaluation. This PT evaluation is not a standard-care practice in the clinic, this was added for research. All participants will complete expectation surveys before and after their evaluation(s). The clinicians will discuss their recommended plan with the patient and the patient will record a final treatment decision and outcome expectations. Participants will then be randomized to either receive posture and movement training (PMT) for 3 weeks or undergo a 3-week wait period. All participants will be required to withhold any treatment during this 3-week period (except PMT in the PMT group). The 3-week wait period for the no-PMT group is aligned with current clinical processes for time from physician evaluation to start of treatment. All participants may proceed with any further interventions (including PMT) after the 3-week period, but none will be provided/required as part of research. Patient-reported outcomes and clinical tests will be recorded before and after the 3-week period, and 3 and 6 months later. Adding a PT evaluation to the physician visit provides no additional risk because the PT evaluation includes similar clinical tests to the physician and movement analysis during tasks participants complete during daily life. Clinical tests before/after the 3-week intervention period may produce muscle soreness that should resolve within 2 days. Understanding how interdisciplinary care influences expectations and outcomes can inform clinicians regarding the effectiveness of interdisciplinary collaboration.

YES

Clinical Decision Making|Nonarthritic Hip Disease

OTHER: Interdisciplinary Evaluation for Nonarthritic Hip Disease|OTHER: Posture and Movement Training|OTHER: Treatment-of-choice

Treatment Plan, Participants will indicate their planned treatment(s), Post-evaluation, same-day (approximately 5-10min after evaluation)|Decisional Conflict, Participants will report decisional conflict related to their treatment plan. Decisional conflict was measured using the Decisional Conflict Scale ranging from 0 (no conflict, better outcome) to 100 (high conflict, worse outcome)., Pre-evaluation, 10min Post-evaluation

Themes From Provider Interviews, Qualitative interviews will be conducted with study providers both before patient participant enrollment and after study completion to collect information on how they feel about the evaluation protocols. Qualitative analysis of this data will count responses based on themes. Data for this report will be provided as the total number of responses (across all providers) that fell within each theme at both time points. Each provider could provide multiple responses., Pre-enrollment (2-7days before patient participant recruitment began), Post-enrollment (1-7 days after patient participant recruitment ended)|Participant Protocol Opinions, Participants will be interviewed to collect information on how they feel about the 1) evaluation protocol(s) and 2) treatment/wait period protocols., 20min post-evaluation, 4 weeks post-evaluation|Decisional Conflict, Participants will report decisional conflict related to their treatment plan. Decisional conflict was measured using the Decisional Conflict Scale ranging from 0 (no conflict, better outcome) to 100 (high conflict, worse outcome). Baseline scores for participants in Period 3 (Laboratory testing) were obtained from participants post-evaluation surveys from Period 1 (clinic evaluation)., 10min post-evaluation, 4-week laboratory visit|Patient-reported Hip Function, Participants will complete validated, reliable surveys for hip function (the Hip Outcome Score Activities of Daily Living [HOSADL] was used and is scored from 0-100 with 0 representing the worst function and 100 representing the best function). Baseline scores for participants in Period 3 (Laboratory testing) were obtained from participants post-evaluation surveys from Period 1 (clinic evaluation)., 10min post-evaluation, 4-week laboratory visit|Movement Mechanics, 3-dimensional movement mechanics will be collected during functional tasks including walking and rising from a chair, Baseline laboratory visit, 4-week laboratory visit

Decisional Regret, Participants will report decision regret related to their treatment plans, Day of enrollment, after all evaluations are complete|Decisional Regret, Participants will report decision regret related to their treatment plans, 4 weeks|Changes in Hip Strength, Strength of hip abductors, adductors, flexors, extenders, internal and external rotators will be collected during maximal voluntary isometric contractions, 4 weeks

Ohio State University

Foundation for Physical Therapy, Inc.|Washington University School of Medicine

ALL

ADULT, OLDER_ADULT

null

112

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

2017H0340

2018-02-27

2019-05-31

2018-05-08

2020-05-06

The Ohio State University Wexner Medical Center Jameson Crane Sports Medicine Institute, Columbus, Ohio, 43202, United States

Study Protocol, https://cdn.clinicaltrials.gov/large-docs/87/NCT03519087/Prot_003.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT03519087/SAP_004.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/87/NCT03519087/ICF_005.pdf

{ "Interdisciplinary Evaluation for Nonarthritic Hip Disease": [ { "intervention_type": "OTHER" } ], "Posture and Movement Training": [ { "intervention_type": "OTHER" } ], "Treatment-of-choice": [ { "intervention_type": "OTHER" } ] }

NCT00705887

A Motivational Enhancement Approach to Skin Cancer Prevention

https://clinicaltrials.gov/study/NCT00705887

null

COMPLETED

The specific aims of this research are: Aim 1 - To describe the UV protection behaviors and beliefs of young adult patients in a dermatology clinic. Aim 2 - To examine whether or not the UV protection behaviors and beliefs of young adult dermatology patients are associated with age, gender, level of education, marital status, contact with skin cancer, time outdoors, skin type, the reason for their visit, and the date of data collection. Aim 3 - To test the efficacy of a motivational enhancement approach to UV protection counseling for young adult dermatology patients, as manifested by favorable changes in UV protection stages of change, UV protection self-efficacy, and UV protection attitudes.

NO

Ultraviolet Rays|Motivation

BEHAVIORAL: Brief Motivational Enhancement Intervention

UV Protection Stages of Change, 6 months

UV Protection Attitudes, 6 months|UV Protection Self-Efficacy, 6 months

null

Oregon Health and Science University

null

ALL

ADULT

null

82

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION

IRB00002996

2006-09

2007-06

2008-06-27

null

2008-06-27

Central Utah Clinic, Dermatology, Provo, Utah, 84604, United States

null

{ "Brief Motivational Enhancement Intervention": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT03004287

2015-12: A Study Exploring the Use of Early and Late Consolidation/Maintenance Therapy

https://clinicaltrials.gov/study/NCT03004287

null

ACTIVE_NOT_RECRUITING

This study will assess whether adding one of the newest multiple myeloma therapies, daratumumab, into the Total Therapy approach helps patients live longer with fewer side effects

NO

Multiple Myeloma

Measure the progression-free survival in patients with high risk multiple myeloma, 48 months

null

University of Arkansas

Janssen, LP

ALL

ADULT, OLDER_ADULT

PHASE2

50

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

206241

2017-07-01

2024-10

2025-10

2016-12-28

null

2023-11-18

University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States

null

{ "Carfilzomib": [ { "intervention_type": "DRUG", "description": "Carfilzomib", "name": "Carfilzomib", "synonyms": [ "Carfilzomib", "Kyprolis" ], "medline_plus_id": "a612031", "generic_names": [ "Carfilzomib" ], "drugbank_id": "DB08889", "wikipedia_url": "https://en.wikipedia.org/wiki/Carfilzomib" } ], "Thalidomide": [ { "intervention_type": "DRUG", "description": "Thalidomide", "name": "Thalidomide", "synonyms": [ "Sedoval", "\u03b1-N-phthalylglutaramide", "Thalidomidum", "(+-)-Thalidomide", "1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)isoindoline", "N-Phthaloylglutamimide", "N-Phthalylglutamic acid imide", "3-Phthalimidoglutarimide", "alpha-(N-Phthalimido)glutarimide", "2,6-dioxo-3-phthalimidopiperidine", "(\u00b1)-thalidomide", "alpha-N-Phthalylglutaramide", "\u03b1-phthalimidoglutarimide", "Thalidomide", "(\u00b1)-N-(2,6-dioxo-3-piperidyl)phthalimide", "N-Phthalyl-glutaminsaeure-imid", "Thalomid", "\u03b1-(N-phthalimido)glutarimide", "Talidomida", "N-(2,6-dioxo-3-piperidyl)phthalimide", "(+-)-N-(2,6-dioxo-3-Piperidyl)phthalimide" ], "medline_plus_id": "a699032", "generic_names": [ "Thalidomide" ], "mesh_id": "D020533", "drugbank_id": "DB01041" } ], "Dexamethasone": [ { "intervention_type": "DRUG", "description": "Dexamethasone", "name": "Dexamethasone", "synonyms": [ "Millicorten", "1-Dehydro-16\u03b1-methyl-9\u03b1-fluorohydrocortisone", "Dextenza", "Decaject-L.A.", "Cortidex", "Dexpak", "Dexam\u00e9thasone", "Dexasone", "Decameth", "Dexametasona", "Methylfluorprednisolone", "Decadron", "Martapan", "Decaspray", "16\u03b1-Methyl-9\u03b1-fluoro-1-dehydrocortisol", "Dexamethasone", "Decaject", "Ozurdex", "16alpha-Methyl-9alpha-fluoro-1-dehydrocortisol", "Decaject L.A.", "TobraDex", "Maxidex", "Hexadrol", "Dexair", "Dexamethasonum", "Dexacidin", "Oradexon", "Hexadecadrol", "Glensoludex", "Neofordex", "Maxitrol", "1-Dehydro-16alpha-methyl-9alpha-fluorohydrocortisone", "9\u03b1-Fluoro-16\u03b1-methylprednisolone", "9alpha-Fluoro-16alpha-methylprednisolone", "Maxidex", "Dexamethasone eye drops", "Eythalm", "Dexafree", "Dropodex", "Maxidex", "Dexamethasone eye drops", "Eythalm", "Dexafree", "Dropodex" ], "medline_plus_id": "a682869", "generic_names": [ "Dexamethasone" ], "nhs_url": "https://www.nhs.uk/medicines/dexamethasone-tablets-and-liquid", "mesh_id": "D018931", "drugbank_id": "DB01234", "wikipedia_url": "https://en.wikipedia.org/wiki/Dexamethasone" } ], "Daratumumab": [ { "intervention_type": "DRUG", "description": "Daratumumab", "name": "Daratumumab", "synonyms": [ "Darzalex", "Daratumumab" ], "medline_plus_id": "a616002", "generic_names": [ "Daratumumab" ], "drugbank_id": "DB09331" } ], "Cisplatin": [ { "intervention_type": "DRUG", "description": "Cisplatin", "name": "Cisplatin", "synonyms": [ "CDDP", "Platinol", "PLATINUM, DIAMMINEDICHLORO-, (SP-4-2)-", "cis-DDP", "CIS-DIAMMINEDICHLOROPLATINUM", "INT-230-6 COMPONENT CISPLATIN", "CIS-DIAMMINEDICHLOROPLATINUM II", "cis-diamminedichloroplatinum(II)", "(SP-4-2)-DIAMMINEDICHLOROPLATINUM", "Cisplatin", "INT230-6 COMPONENT CISPLATIN", "Cis-DDP", "cis-Platinum II", "cisplatino" ], "medline_plus_id": "a684036", "generic_names": [ "Cisplatin" ], "drugbank_id": "DB00515" } ], "Doxorubicin": [ { "intervention_type": "DRUG", "description": "Adriamycin", "name": "Doxorubicin", "synonyms": [ "Adriablastin", "Adriblastina", "Urokit Doxo-cell", "Doxorubicin Hexal", "Doxorubicin NC", "Doxorubicina Funk", "Ribodoxo", "DOXO-cell", "Doxotec", "DOXO cell", "Doxorubicinum", "Adriblastine", "Adriablastine", "Adriblastin", "Rubex", "Doxorubicin", "Doxorubicina Tedec", "Urokit Doxo cell", "14-hydroxydaunomycin", "Hydroxydaunomycin Hydrochloride", "(1S,3S)-3-glycoloyl-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1,2,3,4,6,11-hexahydrotetracen-1-yl 3-amino-2,3,6-trideoxy-\u03b1-L-lyxo-hexopyranoside", "Caelyx", "14-hydroxydaunorubicine", "Hydrochloride, Doxorubicin", "Farmiblastina", "(8S-cis)-10-((3-amino-2,3,6-trideoxy-\u03b1-L-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-5,12-naphthacenedione", "Doxolem", "Onkodox", "MTC-DOX for Injection", "Doxorubicine Baxter", "Doxorubicina Ferrer Farm", "Doxorubicin Hydrochloride", "Adriamycin", "MTC-DOX", "Hydroxydaunorubicin", "Doxorubicine", "Doxorubicin nanoparticles", "Myocet", "Doxorubicina", "Adrimedac" ], "medline_plus_id": "a682221", "generic_names": [ "Doxorubicin" ], "mesh_id": "D059005", "drugbank_id": "DB00997", "wikipedia_url": "https://en.wikipedia.org/wiki/Doxorubicin" } ], "Cyclophosphamide": [ { "intervention_type": "DRUG", "description": "Cyclophosphamide", "name": "Cyclophosphamide", "synonyms": [ "(+-)-Cyclophosphamide", "Cyclophosphamid", "Procytox", "NSC26271", "CPM", "Cytophosphane", "Cyclophosphamide Monohydrate", "Endoxan", "Neosar", "(+,-)-2-(bis(2-Chloroethyl)amino)tetrahydro-2H-1,3,2-oxazaphosphorine 2-Oxide Monohydrate", "N,N-Bis(2-chloroethyl)tetrahydro-2H-1,3,2-oxazaphosphorin-2-amine 2-oxide", "Ciclofosfamida", "Cyclophosphane", "NSC-26271", "Cytophosphan", "Cyclophosphamide anhydrous", "Anhydrous cyclophosphamide", "Bis(2-chloroethyl)phosphoramide cyclic propanolamide ester", "Ciclofosfamide", "(RS)-Cyclophosphamide", "(\u00b1)-2-(BIS(2-CHLOROETHYL)AMINO)TETRAHYDRO-2H-1,3,2-OXAZAPHOSPHORINE 2-OXIDE MONOHYDRATE", "B 518", "CYT", "B518", "Cytoxan", "Cyclophosphamide Anhydrous", "2-[Bis(2-chloroethylamino)]-tetrahydro-2H-1,3,2-oxazaphosphorine-2-oxide", "Cyclophosphamide, (R)-Isomer", "Sendoxan", "NSC 26271", "B-518", "Cyclophosphamidum", "Cyclophosphamide, (S)-Isomer", "Cyclophosphamide" ], "medline_plus_id": "a611044", "generic_names": [ "Cyclophosphamide" ], "mesh_id": "D019653", "drugbank_id": "DB00531" } ], "Etoposide": [ { "intervention_type": "DRUG", "description": "Etoposide", "name": "Etoposide", "synonyms": [ "NSC141540", "Etomedac", "Eto-GRY", "4-demethylepipodophyllotoxin \u03b2-D-ethylideneglucoside", "VP 16213", "NSC 141540", "NSC-141540", "Etoposide, (5a alpha)-Isomer", "Exitop", "Eto GRY", "VP 16 213", "VP16", "Etoposide", "trans-Etoposide", "Etoposide, alpha-D-Glucopyranosyl Isomer", "Toposar", "VP 16-213", "V\u00e9p\u00e9side Sandoz", "V\u00e9p\u00e9side-Sandoz", "Etoposide Teva", "Etoposido Ferrer Farma", "Etopophos", "Vepesid", "(\u2212)-etoposide", "4'-Demethylepipodophyllotoxin 9-(4,6-O-(R)-ethylidene-beta-D-glucopyranoside)", "Celltop", "VP-16", "9-((4,6-O-Ethylidine-beta-D-glucopyranosyl)oxy)-5,8,8a,9-tetrahydro-5-(4-hydroxy-3,4-dimethyloxyphenyl)furo(3',4'':6,7)naptho-(2,3-d)-1,3-dioxol-6(5aH)-one", "alpha-D-Glucopyranosyl Isomer Etoposide", "Riboposid", "Etoposide, (5S)-Isomer", "Eposin", "Etoposide, (5a alpha,9 alpha)-Isomer", "Eposide", "Etoposide Pierre Fabre", "Onkoposid", "Lastet", "Etoposidum", "Etoposido", "VP 16", "Etopos", "Teva, Etoposide", "Demethyl Epipodophyllotoxin Ethylidine Glucoside", "Etoposide, alpha D Glucopyranosyl Isomer" ], "medline_plus_id": "a697011", "generic_names": [ "Etoposide" ], "mesh_id": "D059005", "drugbank_id": "DB00773" } ], "Melphalan": [ { "intervention_type": "DRUG", "description": "Melphalan", "name": "Melphalan", "synonyms": [ "Mustard, Phenylalanine", "Melphalan", "Melphalanum", "3-p-(Di(2-chloroethyl)amino)-phenyl-L-alanine", "3-(p-(Bis(2-chloroethyl)amino)phenyl)-L-alanine", "L-Sarcolysine", "Merphalan", "p-L-Sarcolysin", "p-N-Bis(2-chloroethyl)amino-L-phenylalanine", "p-N,N-bis(2-chloroethyl)amino-L-phenylalanine", "Alkeran", "L-PAM" ], "medline_plus_id": "a612019", "generic_names": [ "Melphalan" ], "mesh_id": "D019653", "drugbank_id": "DB01042" } ], "ASCT": [ { "intervention_type": "PROCEDURE" } ], "Lenalidomide": [ { "intervention_type": "DRUG", "description": "Lenalidomide", "name": "Lenalidomide", "synonyms": [ "Revimid", "CC-5013", "Lenalidomida", "CC5013", "Revlimid", "3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione", "IMiD3 Cpd", "2,6-Piperidinedione, 3-(4-amino-1,3-dihydro-1-oxo-2H- isoindol-2-yl)-", "1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline", "CC 5013", "Lenalidomide" ], "medline_plus_id": "a608001", "generic_names": [ "Lenalidomide" ], "mesh_id": "D020533", "drugbank_id": "DB00480" } ], "Bortezomib": [ { "intervention_type": "DRUG", "description": "Bortezomib", "name": "Bortezomib", "synonyms": [ "[(1R)-3-methyl-1-({(2S)-3-phenyl-2-[(pyrazin-2-ylcarbonyl)amino]propanoyl}amino)butyl]boronic acid", "N-[(1R)-1-(DIHYDROXYBORYL)-3-methylbutyl]-N-(pyrazin-2-ylcarbonyl)-L-phenylalaninamide", "Bortezomib", "Velcade" ], "medline_plus_id": "a607007", "generic_names": [ "Bortezomib" ], "mesh_id": "D000970", "drugbank_id": "DB00188" } ] }

NCT05703087

Positive Cueing in Knee Arthroplasty.

https://clinicaltrials.gov/study/NCT05703087

null

COMPLETED

To the knowledge of the investigators, the feasibility of an RCT assessing the use of positive cueing in an information video for patients undergoing primary TKA is currently unclear. The investigators conducted a feasibility study with the primary objective to assess the acceptability of the randomized controlled trial (RCT) procedure for participating patients. The secondary objective was to evaluate the rate of recruitment, the comprehensibility (do patients understand what is expected of them during the trial) and if there were any adjustments necessary to the design of the study. The outcome of the current feasibility study will be used to determine whether adjustments are required to the design of the RCT before we proceed.

NO

Osteoarthritis, Knee|Psychological Stress|Mental Stress

BEHAVIORAL: Positive cueing in the information video before a primary TKA

Feasibility outcome measure: acceptibility., The primary feasibility outcome score was the acceptability to participate, assessed with a developed questionnaire. The investigators conducted a questionnaire about the experience of the participants with a Likart scale 1 - 5, existing of 4 questions. A total score of 12 or higher was interpreted as acceptable since the patient seemed have a positive experience according to the questionnaire. As part of the primary outcome measure (acceptibility), we monitored the time it took a patient to participate in the study. The study should not take more than one hour to be acceptable., During the preoperative outpatient clinic visit two weeks before surgery. Directly after watching the videos and completing questionnaires.

Feasibility outcome measure: rate of recruitment, We determined the rate of recruitment by dividing the number of patients included in this study by the number of patients waiting for total knee arthroplasty meeting all inclusion criteria who were scheduled to be seen on the preoperative outpatient clinic appointment., The number of the patients on the waiting list for total knee arthroplasty and the included patients were assessed two weeks before surgery, during the outpatient clinic visit.|Feasibility outcome measure: comprehensibility, Do patients understand what is expected of them during the trial. We analyzed comprehensibility for the patients with a developed questionnaire with a cut off point < 9 and by assessing the rate of completion of the questionnaires (number of questions completed). Specific items that were consistently missing from the questionnaires and were not filled out by the patients were noted. Also, patients received one question about whether they thought the information in the video was easy to understand, cut off point < 3., During the preoperative outpatient clinic visit two weeks before surgery. Directly after watching the videos and completing questionnaires.|Feasibility outcome measure:patients feedback to the current protocol., After finishing the questionnaire we asked two feedback questions regarding the protocol: 1. what patients thought of participating in the study, and 2. whether they had suggestions to improve the study process. The feedback from the patients were transcribed and similar answers were categorized., During the preoperative outpatient clinic visit two weeks before surgery. Directly after watching the videos and completing questionnaires.

null

Leiden University Medical Center

Onze Lieve Vrouwe Gasthuis|Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

ALL

ADULT, OLDER_ADULT

null

20

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

WO 21.122

2021-09-21

2021-11-01

2023-01-27

null

2023-01-27

LUMC, Leiden, 2333 ZA, Netherlands

null

{ "Positive cueing in the information video before a primary TKA": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT03916887

Golf for Healthy Aging

https://clinicaltrials.gov/study/NCT03916887

GHA

COMPLETED

Aging is associated with physiological declines that could impair the ability to perform activities of daily living and thus impair the quality of life of older adults. Golf is an activity that challenges the balance, flexibility, and muscular systems of the golfer and could have important implications in addressing the physiological declines associated with aging. Golf also challenges the cognition of golfer and is typically performed in groups of 2-4 people; therefore, it could also have important implications for the cognitive and social health of older adults. This research will investigate the effects of an introductory, therapeutic golf program on the physiological, cognitive, and social well-being of older adults. 25 older adults (60-80 years) will participate in a 10-week introductory golf program specifically designed with older adults in mind. The intervention will be led by Professional Golf Association (PGA) professionals with experience in teaching older adults to golf. In order to assess the effectiveness of the intervention, the functional, physiological, and cognitive abilities of the participants will be evaluated as well as the overall well-being before and after the completion of the golf program. We will also examine the inflammatory response changes associated with the golf program. These adaptations will be evaluated through the use of biomechanical analysis, standardized older adult functional tests, validated surveys and questionnaires, validated cognitive assessments, and analyses of markers of inflammation.

NO

Exercise Training

BEHAVIORAL: Golf instruction

Change in Gait speed, change in walking speed, baseline and after 10 weeks

Change in Strength, change in dynamic and static strength, baseline and after 10 weeks

Change in Cognition, change in NIH Cognitive Toolbox scores, baseline and after 10 weeks|Change in Balance, change in dynamic and static balance, baseline and after 10 weeks

University of Southern California

Royal & Ancient Group

ALL

ADULT, OLDER_ADULT

null

15

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

HS-17-00004

2018-05-31

2019-04-26

2019-04-16

null

2019-06-25

University Southern California, Los Angeles, California, 90089, United States

null

{ "Golf instruction": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT01110187

A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

https://clinicaltrials.gov/study/NCT01110187

null

TERMINATED

Trial to determine if seizure prophylaxis with IV LCM in NSICU patients experiencing mental status changes due to severe traumatic brain injury (sTBI) will result in improved short- and long-term outcomes and better immediate adverse effects when compared to the current standard of care anticonvulsant (IV fPHT) and will be at least as effective as IV fPHT in preventing clinical and sub-clinical seizure activity.

YES

Traumatic Brain Injury

DRUG: lacosamide|DRUG: Fosphenytoin

Number of Adverse Events, The primary outcome measure is the incidence of clinical adverse events. These will be followed by daily clinical observations during the hospital stay. Subjects will be evaluated for e.g., seizures, fever, neurological changes, cardiovascular, hematologic and dermatologic abnormalities, liver failure, renal failure, and death; EKGs will be requested as per ICU routines through day 7., baseline to 7 days

Number of Participants With Seizures, Number of seizures in the first 72 hours based on EEG recording, baseline to 72 hours

null

University of Alabama at Birmingham

UCB Pharma

ALL

ADULT, OLDER_ADULT

null

11

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION

JPS-001

2010-05

2012-05

2010-04-26

2014-04-28

UC Health University Pointe, Cincinnati, Ohio, 45069, United States|UC Health Medical Arts Building, Cincinnati, Ohio, 45219, United States|University Hospital, Cincinnati, Ohio, 45219, United States

null

{ "Lacosamide": [ { "intervention_type": "DRUG", "description": "lacosamide", "name": "Lacosamide", "synonyms": [ "N-benzyl-AcMeOPrNH2", "(+)-(2R)-2-(ACETYLAMINO)-N-BENZYL-3-METHOXYPROPANAMIDE", "Lacosamida", "N-benzyl-2-acetamido-3-methoxypropionamide", "(R)-2-acetamido-N-benzyl-3- methoxypropionamide", "(2R)-2-(Acetylamino)-3-methoxy-N-(phenylmethyl)propanamide", "N benzyl 2 acetamido 3 methoxypropionamide", "Harkoseride", "(R)-LACOSAMIDE 1", "Lacosamide", "Erlosamide", "Propanamide, 2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)-", "N benzyl AcMeOPrNH2", "Vimpat" ], "medline_plus_id": "a609029", "generic_names": [ "Lacosamide" ], "mesh_id": "D061567", "drugbank_id": "DB06218" } ], "Fosphenytoin": [ { "intervention_type": "DRUG", "description": "Fosphenytoin", "name": "Fosphenytoin", "synonyms": [ "Fosphenytoin", "Fosphenytoinum", "(3-Phosphoryloxymethyl)phenytoin", "Cerebyx", "Fosfenitoina", "Fosphenytoine" ], "medline_plus_id": "a619063", "generic_names": [ "Fosphenytoin" ], "drugbank_id": "DB01320" } ] }

NCT04334187

NYCHA Mindfulness-based Smoking Cessation Intervention

https://clinicaltrials.gov/study/NCT04334187

null

WITHDRAWN

The study will assess feasibility, accessibility and impact of a mindfulness-based smoking cessation group intervention for New York City Housing Authority (NYCHA) residents. Residents who smoke to receive an 8-week intervention. Participants will also be offered 4 weeks of nicotine replacement therapy (NRT).

NO

Tobacco Use

BEHAVIORAL: Mindfulness Based addition treatment

Number of participants who perceive the Mindfulness based addiction treatment as useful at time of Enrollment, Participants will report their perceived usefulness and effectiveness of the intervention using self reported surveys at enrollment (baseline)., Baseline|Number of participants who perceive the Mindfulness based addiction treatment as useful after last MBAT session., Number of participants will report their perceived usefulness and effectiveness of the intervention using self reported surveys after their last MBAT session (2 months after enrollment)., 2 months|Number of participants who perceive the Mindfulness based addiction treatment as useful post treatment, Participants will report their perceived usefulness and effectiveness of the intervention using self reported surveys one month after completing treatment (3 months post-enrollment)., 3 months|Number of participants who perceive the Mindfulness based addiction treatment as effective, Participants who self-report 7-day abstinence in the final follow up survey (3 months) will provide a biochemically validated saliva sample, 3 months

Number of participants who adhered to the Mindfulness based addiction treatment, This will be reported in the number of sessions attended and completed mindfulness exercises in between the sessions., 3 months|Number of participants who self reported abstinence, This will be self reported at the end of the treatment (2 months), 2 months

null

NYU Langone Health

null

ALL

ADULT, OLDER_ADULT

null

0

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

19-01435

2021-06

2021-12

2020-04-06

null

2022-03-02

null

{ "Mindfulness Based addition treatment": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT05073887

A Comparison of Ultrasound Guided Genicular Nerve Blockade Using Current Versus Revised Anatomical Targets

https://clinicaltrials.gov/study/NCT05073887

null

COMPLETED

comparison of effectiveness of ultrasound guided genicular nerve blockades and radio frequency stimulation

NO

Knee Pain Chronic

PROCEDURE: Current Targets

Numerical Rating Scale, Pain will be evaluated with a Numerical Rating Scale (NRS) score of 0-10 (0= no pain and 10= worst imaginable pain), Post injection sixth month

null

Diskapi Teaching and Research Hospital

null

ALL

ADULT, OLDER_ADULT

null

80

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

106/01

2021-03-10

2021-12-10

2021-12-20

2021-10-12

null

2022-04-19

Diskapi Yildirim Beyazit Training and Research Hospital, Ankara, 06110, Turkey

null

{ "Current Targets": [ { "intervention_type": "PROCEDURE" } ] }

NCT03095287

Alphanate in Immune Tolerance Induction Therapy

https://clinicaltrials.gov/study/NCT03095287

null

TERMINATED

This is a multicenter, multinational, prospective, single-arm, nonrandomized, open-label study, planned in of approximately 25 male participants with congenital hemophilia A who will receive their first (primary) immune tolerance induction (ITI) treatment with alphanate. The study consists of 2 phases: * An ITI Treatment Phase in which all eligible participants will receive ITI treatment with alphanate for a period of up to 33 months. Upon confirmation of complete immune tolerization, participants will then enter a 12-month Prophylactic Phase. If, after 33 months of ITI, a participants has achieved partial immune tolerance, the participants will enter a 12-month Prophylactic Phase. * A 12-month Prophylactic Phase for all participants who meet the criteria for complete or partial success to continue on a prophylactic dosing regimen of alphanate. Due to limited enrollment, this study was early terminated.

YES

Hemophilia A, Congenital

BIOLOGICAL: Alphanate

Percentage of Participants Who Achieved Complete Immune Tolerance Within 33 Months of Initiation of Immune Tolerance Induction (ITI) Treatment Phase, Complete immune tolerance was defined as the participants achieving 2 consecutive undetectable inhibitor titers (<0.6 BU) performed within 2 weeks of each other, Factor VIII activity (FVIII:C) in vivo plasma recovery ≥66% of the predicted normal value and FVIII:C half-life ≥6 hours after a 72-hour FVIII treatment-free period., Up to 32.5 months

Percentage of Participants Who Achieved Either Complete or Partial Immune Tolerance Within 33 Months of Initiation of ITI Treatment Phase, Complete immune tolerance was defined as the participants achieving 2 consecutive undetectable inhibitor titers (<0.6 BU) performed within 2 weeks of each other, Factor VIII activity (FVIII:C) in vivo plasma recovery ≥66% of the predicted normal value and FVIII:C half-life ≥6 hours after a 72-hour FVIII treatment-free period. Partial immune tolerance was defined as participants achieving reduction of inhibitor titer to <5 BU confirmed at 2 consecutive assessments within 2 weeks of each other, FVIII:C in vivo plasma recovery of <66% of the predicted normal value or FVIII:C half-life of <6 hours after a 72-hour FVIII treatment-free period and clinical response to FVIII therapy., Up to 32.5 months|Percentage of Participants Who Achieved Complete or Partial Immune Tolerance Without Relapse During the Prophylactic Phase, Relapse during the prophylactic phase for participants who have achieved complete immune tolerance was defined as a return of FVIII inhibitor titer to detectable levels (≥0.6 BU) or FVIII:C recovery <66% of the predicted normal value or FVIII:C half-life <6 hours, confirmed by repeat assessment within approximately 2 weeks. Relapse for participants who have achieved partial immune tolerance was defined as an increase of FVIII inhibitor titer to ≥5 BU, confirmed by repeat assessment within approximately 2 weeks., 12 months during prophylactic phase|Number of Bleeding Events During ITI Treatment Phase and Prophylactic Phase, Annualized frequencies of bleeding events during the ITI Treatment Phase and the Prophylactic Phase, Up to 32.5 months

Treatment-emergent Adverse Events, Incidence of treatment-emergent adverse events during the ITI Treatment Phase and Prophylactic Phase, Up to 32.5 months

Grifols Therapeutics LLC

Grifols Biologicals, LLC

MALE

CHILD

PHASE2

2

INDUSTRY

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

GBI1406|2015-005524-26

2018-01-03

2020-09-18

2017-03-29

2021-11-23

Emory University, Atlanta, Georgia, 30322, United States|University of Kentucky, Lexington, Kentucky, 40536, United States|Childrens Hospital and Clinics of Minnesota, Minneapolis, Minnesota, 55404, United States|The Childrens Mercy Hospital, Kansas City, Missouri, 64108, United States|Robert Wood Johnson Medical Group, New Brunswick, New Jersey, 08901, United States|Newark Beth Israel Medical Center & Childrens Hospital of New Jersey, Newark, New Jersey, 07112, United States|University of North Carolina at Chapel Hill, Hemophilia and Thrombosis Center, Chapel Hill, North Carolina, 27517, United States|Seattle Childrens Hospital, Seattle Childrens Research Institute, Seattle, Washington, 98101, United States|McMaster Childrens Hospital, Hamilton, Ontario, L8N-3Z5, Canada|Lokmanya Tilak Municipal Medical College & General Hospital, Mumbai, Maharashtra, 400022, India|B. J. Govt. Medical College & Sassoon Hospital, Pune, 411001, India|A.O.U. Santa Maria della Misericordia Perugia, Perugia, Umbria, 6132, Italy|Azienda Ospedaliera Universitaria Careggi, Firenze, 50134, Italy|Universita degli Studi di Roma La Sapienza, Roma, 00161, Italy|Kemerovo Regional Clinical Hospital, Kemerovo, 650061, Russian Federation|FGUs Hospital - Kirov Scientific Research Institute, Kirov, 610027, Russian Federation|Center for Hemophilia Treatment St.-Petersburg, Saint Petersburg, 191186, Russian Federation|Hospital Universitari i Politecnic La Fe, Valencia, Autonomous Community Of Valencia, 46026, Spain|Hospital Universitario La Paz, Madrid, 28046, Spain|Hospital Universitario Virgen del Rocio, Sevilla, 41013, Spain

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT03095287/Prot_SAP_001.pdf

{ "Alphanate": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT04921787

EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy

https://clinicaltrials.gov/study/NCT04921787

EXHITENTRE

RECRUITING

This study is a multi-site, cluster randomized, two group implementation trial comparing a low- versus high-intensity implementation strategy for supporting hospital-based opioid use disorder treatment (HBOT) in community hospital settings where medication for opioid use disorder (MOUD) treatment has not been implemented.

NO

Substance Use Disorders|Opioid Use Disorder, Severe|Opioid Use Disorder, Moderate

OTHER: Low Intensity|OTHER: High Intensity

Engagement with MOUD, measured as the proportion of community hospital OUD discharges engaged with MOUD within 34 days following hospital discharge during months 13-24 of the intervention., 34 days following hospital discharge

null

Hennepin Healthcare Research Institute

National Institute on Drug Abuse (NIDA)|The Emmes Company, LLC

ALL

CHILD, ADULT, OLDER_ADULT

null

24

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH

NIDA CTN 0098B|2UG1DA040316-06

2021-10-22

2025-12

2026-04

2021-06-10

null

2024-06-17

Boston University, Boston, Massachusetts, 02119, United States|Hennepin Healthcare Research Institute, Minneapolis, Minnesota, 55404, United States|New York University, New York, New York, 10016, United States|Oregon Health & Science University, Portland, Oregon, 97239, United States

null

{ "Low Intensity": [ { "intervention_type": "OTHER" } ], "High Intensity": [ { "intervention_type": "OTHER" } ] }

NCT01852487

Effect of Pumpkin Seed Oil on Hair Growth in Men With Androgenetic Alopecia

https://clinicaltrials.gov/study/NCT01852487

null

COMPLETED

Androgenic alopecia is the most common cause of hair loss in men. Finasteride and minoxidil are available in treatment of androgenetic alopecia, although the former causes decreased libido or ejaculate volume, erectile dysfunction, the latter causes scaling, itching of the scalp. Recently, Pulpkin Seed Oil shows some improved clinical efficacy on scalp hair growth in men with androgenetic alopecia, but there is no evidence to support this. The investigators conducted a randomized, double-blind, placebo-controlled efficacy and tolerability trial of Pumpkin seed oil (400mg/day)therapy in male patients with androgenetic alopecia.

NO

Androgenic Alopecia

DIETARY_SUPPLEMENT: 400mg /day during 6 months

investigator assessment score using photographs of scalp hair, at weeks 12 and 24

patient self-assessment scores, at weeks 12 and 24

hair analysis using phototrichogram, at weeks 12 and 24

Dream Plus

null

MALE

ADULT, OLDER_ADULT

null

80

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

Pumpkin0912

2012-02

2012-12

2013-05-13

null

2013-05-13

Pusan National University Yangsan Hospital, Yangsan, Gyeongsangnam-do, 626-770, Korea, Republic of

null

{ "400mg /day during 6 months": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ] }

NCT03170687

Comparative Outcomes Between Foot Cast and Short Leg Cast in the Patients With Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)

https://clinicaltrials.gov/study/NCT03170687

null

COMPLETED

This study aims to compare outcomes of short leg cast and foot cast for treatment acute fifth metatarsal fracture (Zone II).

NO

Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)

DEVICE: short foot cast|DEVICE: short leg cast

VAS, visual analog score, 8 weeks

AOFAS, foot score, 8 weeks|union rate, radiographic union, 8 weeks|complication, skin ulcer or compartment syndrome, 8 weeks

rescue medication, paracetamol or NSAIDs, 8 weeks

Jatupon Kongtharvonskul

Police General Hospital

ALL

CHILD, ADULT, OLDER_ADULT

null

72

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

53/2560

2017-01-24

2018-09-01

2017-05-31

null

2018-09-18

Jatupon Kongtharvonskul, Bangkok, Select..., 10400, Thailand

null

{ "short foot cast": [ { "intervention_type": "DEVICE" } ], "short leg cast": [ { "intervention_type": "DEVICE" } ] }

NCT04674787

Uncertainty Analysis of Computational Model to Simulate Neurostimulation Caused by Gradient Fields in MRI

https://clinicaltrials.gov/study/NCT04674787

NEUROMAN

COMPLETED

The aim of this research project is to quantify the uncertainty of current state-of-the art anatomical phantoms and computational models for predicting neurostimulation induced by time-varying magnetic fields (so-called gradient fields) within the context of magnetic resonance imaging (MRI) scanners. For this purpose stimulation thresholds will be measured in a volunteer study. The measurements will provide valuable data for the development and validation of future models.

NO

Peripheral Nerve Stimulation in MRI|Electric Stimulation

OTHER: Peripheral nerve stimulation provocation study

Measure PNS stimulation thresholds, The primary objective is to measure PNS stimulation thresholds in order to quantify the modeling uncertainty and reliability., The experimental procedure will be conducted during a single visit of approx. 90 minutes.

null

Bryn Lloyd

Institute for Biomedical Engineering, Swiss Federal Institute of Technology (ETH Zurich)

ALL

ADULT, OLDER_ADULT

null

12

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE

NEUROMAN

2021-03-01

2021-03-20

2020-12-19

null

2021-05-26

ITIS Foundation, Zurich, ZH, 8092, Switzerland

null

{ "Peripheral nerve stimulation provocation study": [ { "intervention_type": "OTHER" } ] }

NCT06308887

Comparison of Ultrasound-Guided Perimeniscal Steroid and 5% Dextrose Injections in Knee Osteoarthritis

https://clinicaltrials.gov/study/NCT06308887

null

COMPLETED

Introduction: The primary goal of treating knee osteoarthritis is to reduce pain and improve the patients quality of life. Medial meniscal extrusion is a condition that is linked to pain and disability in knee osteoarthritis and can be identified through ultrasound. For patients with medial meniscal extrusion, perimeniscal corticosteroid injection has been shown to be a helpful addition to primary treatment for moderate to severe pain relief. Dextrose prolotherapy has also been found to provide periarticular benefits for knee osteoarthritis. This study aims to compare the effectiveness of ultrasound-guided perimeniscal corticosteroid and perimeniscal dextrose injections in patients with osteoarthritis, medial knee pain, and medial meniscal extrusion. Method: Patients with medial knee pain and meniscal extrusion were randomly divided into two groups using the double-block randomization method. Group 1 included 15 patients who were administered an ultrasound-guided perimeniscal steroid injection, while Group 2 included 16 patients who were administered an ultrasound-guided perimeniscal dextrose injection. The patients pain levels were evaluated using the Visual Analog Pain Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) before and one week, one month, and three months after the injection.

NO

Gonarthrosis|Meniscus; Degeneration|Pain, Chronic

DRUG: Triamcinolone Hexacetonide|DRUG: Dextrose 5% in water

Visual Analogue Scale, The pain VAS is a unidimensional measure of pain intensity, used to record patients pain progression or compare pain severity between patients with similar conditions.VAS is comprised of a horizontal line of 10 cm in length. A measurement of 0 cm indicates the absence of pain, whereas a measurement of 10 cm signifies the most severe pain that one can conceive. Patients are instructed to assess the intensity of discomfort by indicating a point on this line., At the beginning, 1.,4., 12. week

Western Ontario and McMaster University Osteoarthritis Index, The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of hip and knee osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain, stiffness, and physical function. The test questions are scored on a scale of 0-4, which corresponds to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. Usually, a sum of the scores for all three subscales gives a total WOMAC score, and higher scores mean a worse outcome., At the beginning, 1.,4., 12. week

null

Kastamonu University

null

ALL

ADULT, OLDER_ADULT

PHASE4

31

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT

1

2023-10-02

2024-02-02

2024-03-02

2024-03-13

null

2024-03-13

Gamze Gül Güleç, Kastamonu, 37150, Turkey

null

{ "Triamcinolone": [ { "intervention_type": "DRUG", "description": "Triamcinolone Hexacetonide", "name": "Triamcinolone", "synonyms": [ "Triamcinolona", "Triacort", "Aristogel", "9-fluoro-11\u03b2,16\u03b1,17,21-tetrahydroxypregna-1,4-diene-3,20-dione", "Fluoxyprednisolone", "11\u03b2,16\u03b1,17\u03b1,21-tetrahydroxy-9\u03b1-fluoro-1,4-pregnadiene-3,20-dione", "Volon", "Adcortyl", "Aristocort", "Triamcinolone", "Tiamcinolonum", "Kenalog", "Triamcinolonum", "9\u03b1-fluoro-16\u03b1-hydroxyprednisolone", "Triderm", "Nasacort", "9\u03b1-fluoro-11\u03b2,16\u03b1,17,21-tetrahydroxypregna-1,4-diene-3,20-dione", "9\u03b1-fluoro-11\u03b2,16\u03b1,17\u03b1,21-tetrahydroxypregna-1,4-diene-3,20-dione", "Oralone" ], "medline_plus_id": "a601124", "generic_names": [ "Triamcinolone" ], "mesh_id": "D005938", "drugbank_id": "DB00620", "wikipedia_url": "https://en.wikipedia.org/wiki/Triamcinolone" } ], "Dextrose 5% in water": [ { "intervention_type": "DRUG" } ] }

NCT01359787

Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)

https://clinicaltrials.gov/study/NCT01359787

null

COMPLETED

The purpose of this study is to evaluate the efficacy and safety of three concentrations of a development drug compared to ointment base (vehicle) in subjects with Atopic Dermatitis (AD).

NO

Atopic Dermatitis|Eczema

DRUG: Mapracorat|DRUG: Vehicle without active

Eczema Area and Severity Index (EASI), Over all study visits for up to 4 weeks

Subjects´ assessment of pruritus, Subjects´ assessment of pruritus using a visual analog scale (VAS), At baseline and after 4 weeks of treatment

null

Bayer

null

ALL

ADULT, OLDER_ADULT

PHASE2

197

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

15616|1403440|2010-024279-14

2011-05

2011-09

2011-05-25

null

2015-01-21

Berlin, 10589, Germany

null

{ "Mapracorat": [ { "intervention_type": "DRUG", "description": "Mapracorat", "name": "Mapracorat", "synonyms": [ "Mapracorat" ], "drugbank_id": "DB12041", "generic_names": [ "Mapracorat" ] } ], "Vehicle without active": [ { "intervention_type": "DRUG" } ] }

NCT00985387

Evaluation of Adherence to Solifenacin Treatment in Overactive Bladder Patients

https://clinicaltrials.gov/study/NCT00985387

null

COMPLETED

The purpose of the study is to assess patients persistency in maintaining solifenacin treatment for overactive bladder.

NO

Urinary Bladder, Overactive|Overactive Bladder

DRUG: Solifenacin

percentage of patients who are maintaining solifenacin treatment, Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12

percentage of patients who discontinued solifenacin treatment, Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12|percentage of patients who switched to other OAB medication, Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12

null

Astellas Pharma Inc

Astellas Pharma Korea, Inc.

ALL

ADULT, OLDER_ADULT

null

1,215

INDUSTRY

OBSERVATIONAL

Observational Model: |Time Perspective: p

SPK-1

2009-08

2011-08

2009-09-28

null

2011-10-12

null

{ "Solifenacin": [ { "intervention_type": "DRUG", "description": "Solifenacin", "name": "Solifenacin", "synonyms": [ "Solifenacin", "VESIcare", "Solifenacina", "Vesicare" ], "medline_plus_id": "a605019", "generic_names": [ "Solifenacin" ], "nhs_url": "https://www.nhs.uk/medicines/solifenacin", "drugbank_id": "DB01591" } ] }

NCT04501887

The Efficacy of Precision Treatment for Gastric Cancer Guided by Molecular Profiling

https://clinicaltrials.gov/study/NCT04501887

null

UNKNOWN

Gastric cancer (GC) is one of the most common and lethal cancers worldwide, especially in China, and the median overall survival for patients with advanced, metastatic GC remains only about 1 year. Several molecular profiling studies have demonstrated that a proportion of gastric cancer harbour actionable molecular alterations which shows a predictive benefit from a specific therapy (in any cancer type). In the current study, the efficacy of precision treatment for gastric cancer guided by multidimensional molecular biology profiling will be observed. The analysis focused on the overall survival outcomes for patients whose tumours harboured actionable molecular alterations and who received appropriately matched therapy.

NO

Gastric Cancer

null

Overall survival, Overall survival was measured from the date of advanced disease until death., up to 3 years|Progression-free survival, The PFS was calculated from the date of advanced disease to the date of disease progression or death, up to 3 years

Positive rate, Actionable molecular alterations detected by molecular profiling, up to 3 years

null

Shanghai Zhongshan Hospital

null

ALL

ADULT, OLDER_ADULT

null

1,000

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

ZS-ON-100

2021-01-01

2022-07-01

2023-07-01

2020-08-06

null

2020-08-06

null

{}

NCT02024087

Study of Dalantercept and Sorafenib in Patients With Advanced Hepatocellular Carcinoma

https://clinicaltrials.gov/study/NCT02024087

null

COMPLETED

The purpose of this study is to evaluate the safety and tolerability of dalantercept plus sorafenib in patients with advanced hepatocellular carcinoma (HCC) to determine the recommended dose level of dalantercept in combination with sorafenib.

YES

Advanced Adult Hepatocellular Carcinoma

DRUG: Dalantercept plus sorafenib

Number of Participants With Adverse Events as a Measure of Safety and Tolerability., Assessed by monitoring AEs using the current active minor version on the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 4.0 (NCI-CTCAE v4 current minor version), physical examinations, vital signs, clinical laboratory test, ECHO, ECG and ADA testing; through final study visit, up to approximately 20 weeks from first dose of dalantercept., up to approximately 20 weeks

Best Overall Response, The Best Overall Response (BOR) is the best response recorded from the start of the study treatment until the disease progression/recurrence, scored as one of the following: Complete Response (CR); Partial Response (PR); Stable Disease (SD) or Progressive Disease (PD). Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), a CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. A PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD is defined as At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study., up to approximately 20 weeks|Overall Survival (OS), The proportion of participants alive from the initiation of treatment through end of study, up to approximately 20 weeks|Disease Control Rate (DCR), Percentage of patients whose disease improves or remains stable over a certain time period. DCR is the sum of the complete, partial and stable disease rates., up to approximately 20 weeks

null

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

null

ALL

ADULT, OLDER_ADULT

PHASE1|PHASE2

21

INDUSTRY

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT

A041-05|ACE-041

2014-08-04

2017-07-05

2017-09-22

2013-12-31

2020-12-22

2022-09-26

The University of Chicago Medical Center, Chicago, Illinois, United States|University of Kansas Medical Center (KUMC), Westwood, Kansas, United States|Beth Israel Deaconess Medical Center (BIDMC), Boston, Massachusetts, United States|Hackensack University Medical Center, Hackensack, New Jersey, United States|Memorial Sloan-Kettering Cancer Center, New York, New York, United States|University of Rochester, Rochester, New York, United States|University of Cincinnati Cancer Institute, Cincinnati, Ohio, United States

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT02024087/Prot_SAP_001.pdf

{ "Dalantercept": [ { "intervention_type": "DRUG", "description": "Dalantercept plus sorafenib", "name": "Dalantercept", "synonyms": [ "Dalantercept" ], "drugbank_id": "DB14988", "generic_names": [ "Dalantercept" ] } ], "Sorafenib": [ { "intervention_type": "DRUG", "description": "Dalantercept plus sorafenib", "name": "Sorafenib", "synonyms": [ "Sorafenibum", "BAY 43-9006", "BAY 43 9006", "Sorafenib N Oxide", "BAY 5459085", "N-(4-Chloro-3-(trifluoromethyl)phenyl)-N'-(4-(2-(N-methylcarbamoyl)-4-pyridyloxy)phenyl)urea", "4-(4-(3-(4-Chloro-3-trifluoromethylphenyl)ureido)phenoxy)pyridine-2-carboxylic acid methyamide-4-methylbenzenesulfonate", "BAY 439006", "Soraf\u00e9nib", "BAY 673472", "Sorafenib N-Oxide", "BAY-673472", "Sorafenib Tosylate", "BAY 545-9085", "BAY 545 9085", "BAY5459085", "4-(4-((((4-Chloro-3-(trifluoromethyl)phenyl)amino)carbonyl)amino)phenoxy)-N-methyl-2-pyridinecarboxamide", "Nexavar", "BAY-545-9085", "Sorafenib" ], "medline_plus_id": "a607051", "generic_names": [ "Sorafenib" ], "mesh_id": "D047428", "drugbank_id": "DB00398" } ] }

NCT05410587

Fracture Monitor - Femur

https://clinicaltrials.gov/study/NCT05410587

null

RECRUITING

Thirty-seven patients diagnosed with femoral fracture to be treated with a compatible plate will be enrolled for this multicenter prospective interventional study. The Fracture Monitor T1 will be attached to the locking plate during osteosynthesis. Prior to discharge, it will be connected to an app installed either on the patients smartphone or on the smartphone provided by the sponsor. The device will continuously collect and process data, which can automatically be downloaded via Bluetooth through the smartphone app and transferred in encrypted form to a dedicated cloud server. The smartphones will be equipped with a basic app version with rudimentary user interface that has no data visualization function. During the rehabilitation phase, data collected by the device will not be accessible to the surgeon nor the patient to ensure that no therapeutic decision will be made based on the acquired data. Every patient is treated as per standard of care. The primary objective of the study is to collect safety information of the Fracture Monitor T1. The secondary objectives are to collect information on device performance, device handling, and usability. All adverse events (AEs) and serious AEs (SAEs) will be recorded during the study. These will be reviewed and evaluated for their potential relationship to the device. All patients will be followed up for 6 months after the surgery according to the local standard of care. Given that the removal of the Fracture Monitor T1 may occur beyond 6 months, a safety follow-up will take place at the time point when the Fracture Monitor T1 is removed as per the instructions for use if it has not been removed within the 6 months. The results will be compiled into a clinical evaluation report to be submitted as part of the technical documentation for the conformity assessment procedure.

NO

Femoral Fracture

DEVICE: Fracture Monitor (implantable device class III)

Incidence of ADEs, To evaluate the safety, (ie the incidence of adverse device effects (ADEs), of the investigational device Fracture Monitor T1 in femoral fracture patients), 6 months postsurgery

Clinical performance: Relationship - implant load/bone healing, Relationship between relative implant load and bone healing status, 6 months|Clinical performance: Relationship - implant load/weight bearing, Relationship between relative implant load and prescribed weight bearing, 6 months|Clinical performance: Relationship - implant load/Function Index for Trauma(FIX-IT), Relationship between relative implant load and Function Index for Trauma (FIX-IT) score FIX-IT: max 12 points - 0 worse/12 best, 6 months|Clinical performance: Relationship - implant load/Patient reported outcomes, Relationship between relative implant load and Patient reported outcomes: pain, EuroQol 5- dimension (EQ-5D) EQ-5D health states can be summarised using a 5-digit code or represented by a single summary number (index value) which reflects how good or bad a health state is according to the preferences of the general population of a country/region., 6 months|Clinical performance: Relationship - implant load/Modified Radiographic union score for tibia(mRUST), Relationship between relative implant load and mRUST score. mRUST: The mRUST score ranges from 4-16 as the four cortices assessed in two orthogonal planes have a score range from 1 to 4 (1: absent callus - 4 callus remodeled), 6 months|Clinical performance: Curve drop, Analyses of the loading curve drop based on: -Time to curve drop, 6 months|Clinical performance: Difference curve drop/soc x-ray, Analyses of the loading curve drop based on: * Difference in the timing between drop in the loading curve (50%) and standard-of-care x-ray, 6 months|Other safety parameters: AEs, - Incidence of adverse events (AEs), 6 months|Other safety parameters: DD, - Incidence of device deficiencies within 6 months, 6 months|Technical performance in a clinical setup, • Average minimum sensor strain per loading event, 6 months|Technical performance in a clinical setup, • Daily active time of implant (patient activity triggers recording of implant), 6 months|Technical performance in a clinical setup, • Number of daily activations (implant switches from idle to recording), 6 months|Technical performance in a clinical setup, • User calibration range (patient-specific calibration on stiffness of fixation construct), 6 months|Technical performance in a clinical setup, • Data down and upload frequency, 6 months|Technical performance in a clinical setup, • Number of Bluetooth adverts, 6 months|Technical performance in a clinical setup, • Bluetooth signal strength (dBm), 6 months|Technical performance in a clinical setup, • Bluetooth connection time (s), 6 months|Technical performance in a clinical setup, • Battery voltage after each month, 6 months|Technical performance in a clinical setup, • Power consumption (device lifetime), 6 months|Technical performance in a clinical setup, • Internal device temperature, 6 months|Technical performance in a clinical setup, • Initialization and daily system test results, 6 months|Technical performance in a clinical setup, • Internal clock accuracy, 6 months

null

AO Innovation Translation Center

null

ALL

ADULT, OLDER_ADULT

null

37

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

FM_AO_001

2023-10-03

2024-10

2025-07

2022-06-08

null

2023-11-14

Universitätsklinikum des Saarlandes, Homburg, Germany|Universitätsklinikum Münster, Münster, Germany|Berufsgenossenschaftliche Unfallklinik Tübingen, Tübingen, Germany|Universitätsklinikum Ulm, Ulm, Germany

null

{ "Fracture Monitor (implantable device class III)": [ { "intervention_type": "DEVICE" } ] }

NCT03824587

Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy

https://clinicaltrials.gov/study/NCT03824587

null

COMPLETED

This is a randomized, double-blind, placebo-controlled study to evaluate the effect of tenapanor on change in s-P levels when tenapanor is administered orally, twice daily for 28 days as adjunctive therapy to ESRD subjects with hyperphosphatemia on stable phosphate binder therapy.

YES

Hyperphosphatemia

DRUG: Tenapanor|DRUG: Placebo|DRUG: Phosphate Binder Agents

Change in Serum Phosphorus (s-P) Level From Baseline to Week 4., Difference in mean change from baseline in s-P level at Week 4 between the tenapanor and placebo groups., 4 Weeks (28 days randomization period; from baseline to week 4)

s-P Response at Week 4, Achieving an s-P level <5.5 mg/dL, 4 Weeks (28 days randomization period)|Relative Change From Baseline in iFGF23 at Week 4, iFGF23 at Week 4/baseline iFGF23 - 1, 4 Weeks (28 days randomization period)|Relative Change From Baseline in cFGF23 at Week 4, cFGF23 at Week 4/baseline cFGF23 - 1, 4 Weeks (28 days randomization period)

null

Ardelyx

null

ALL

ADULT, OLDER_ADULT

PHASE2|PHASE3

236

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT

TEN-02-202

2019-02-28

2019-07-17

2019-01-31

2023-03-06

Nephrology Consultants, LLC, Huntsville, Alabama, 35805, United States|US Renal Care Pine Bluff, Pine Bluff, Arkansas, 71603, United States|Southeast Renal Research, Beverly Hills, California, 90211, United States|California Institute of Renal Research - Chula Vista, Chula Vista, California, 91910, United States|North America Research Institute, Lynwood, California, 90262, United States|DaVita Clinical Research - Santa Fe Spring, Montebello, California, 90640, United States|Central Coast Nephrology, Salinas, California, 93901, United States|North America Research Institute - San Dimas, San Dimas, California, 91773, United States|Chabot Nephrology Medical Group, Union City, California, 94587, United States|American Institute of Research, Whittier, California, 90603, United States|Nova Clinical Research, LLC, Bradenton, Florida, 34209, United States|Horizon Research Group - Coral Gables, Coral Gables, Florida, 33134, United States|South Florida Research Institute, Lauderdale Lakes, Florida, 33313, United States|Total Research Group, LLC, Miami, Florida, 33126, United States|Omega Research Consultants, LLC, Orlando, Florida, 32810, United States|Genesis Clinical Trials, Tampa, Florida, 33614, United States|Dialysis Clinic, Inc - Albany GA, Albany, Georgia, 31701, United States|Boise Kidney & Hypertension, PLLC - Meridian, Caldwell, Idaho, 83605, United States|Renal Associates of Baton Rouge, Baton Rouge, Louisiana, 70808, United States|Dialysis Clinic, Inc - Boston/Somerville, Boston, Massachusetts, 02111, United States|Paragon Health PC - Nephrology Center, Kalamazoo, Michigan, 49007, United States|InterMed Consultants, Minneapolis, Minnesota, 55404, United States|Nephrology and Hypertension Associates, LTD, Tupelo, Mississippi, 38801, United States|Clinical Research Consultants, LLC, Kansas City, Missouri, 64111, United States|Dialysis Clinic, Inc - Kansas City, Kansas City, Missouri, 64131, United States|Polack Renal, LLC (SMO), Saint Louis, Missouri, 63121, United States|Kidney Specialists of Southern Nevada, Las Vegas, Nevada, 89107, United States|Sierra Nevada Nephrology Consultants, Reno, Nevada, 89511, United States|Dialysis Clinic, Inc - North Brunswick, North Brunswick, New Jersey, 08902, United States|Renal Medicine Associates, Albuquerque, New Mexico, 87109, United States|U.S. Renal Care - Gallup, Gallup, New Mexico, 87301, United States|Northwell Health, Great Neck, New York, 11021, United States|Mountain Kidney and Hypertension Associates, Asheville, North Carolina, 28801, United States|Mountain Kidney & Hypertension Associates, P.A., Asheville, North Carolina, 28805, United States|Durham Nephrology Associates, Durham, North Carolina, 27704, United States|Southeastern Nephrology Associates - Wilmington, Wilmington, North Carolina, 28401, United States|University of Cincinnati (UC) - Department of Nephrology, Cincinnati, Ohio, 45267, United States|Northeast Clinical Research Center, Bethlehem, Pennsylvania, 18017, United States|Columbia Nephrology Associates, P.A., Columbia, South Carolina, 29203, United States|South Carolina Nephrology & Hypertension Center Inc., Orangeburg, South Carolina, 29118, United States|DCI - Spartanburg, Spartanburg, South Carolina, 29301, United States|Knoxville Kidney Center, PLLC, Knoxville, Tennessee, 37923, United States|Med Center Dialysis, Houston, Texas, 77004, United States|US Renal Care - Waxahachie, Mansfield, Texas, 76063, United States|US Renal Care - Mesquite, Mesquite, Texas, 75150, United States|Clinical Advancement Center, PLLC, San Antonio, Texas, 78212, United States|US Renal Care - Pleasanton Road, San Antonio, Texas, 78221, United States|US Renal Care - Westover Hills, San Antonio, Texas, 78251, United States

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT03824587/Prot_SAP_000.pdf

{ "Tenapanor": [ { "intervention_type": "DRUG", "description": "Tenapanor", "name": "Tenapanor", "synonyms": [ "Tenapanor", "Ibsrela" ], "drugbank_id": "DB11761", "generic_names": [ "Tenapanor" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Tenapanor" } ], "Placebo": [ { "intervention_type": "DRUG" } ], "Phosphate ion": [ { "intervention_type": "DRUG", "description": "Phosphate Binder Agents", "name": "Phosphate ion", "synonyms": [ "Phosphate", "Orthophosphate", "Phosphate ion" ], "drugbank_id": "DB14523", "generic_names": [ "Phosphate ion" ] } ] }

NCT02982187

A Clinical Study Assessing Critical Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA® Dry Powder Inhaler, in Comparison to Combinations of Dry Powder Inhalers Used to Provide Triple Therapy, in Patients With Chronic Obstructive Pulmonary Disease

https://clinicaltrials.gov/study/NCT02982187

null

COMPLETED

This is a randomized, multi-centre, open-label, placebo-device, cross-over study, with a 2x2 complete block design in subjects with chronic obstructive pulmonary disease (COPD) to assess the benefits of delivering triple therapy using a single ELLIPTA dry powder inhaler (DPI) (closed triple therapy) versus delivering triple therapy using two different types of DPI (open triple therapy). The primary objective of the study is to evaluate the proportion of COPD subjects who make critical errors when using a single ELLIPTA DPI versus those using combinations of DISKUS® with HANDIHALER®, or TURBUHALER® with HANDIHALER. At Visit 1, all subjects will demonstrate the use of ELLIPTA DPI, and HANDIHALER DPI in combination with either DISKUS DPI (in sub-study 1) or TURBUHALER DPI (in sub-study 2), based on the treatment sequences. At the end Visit 1, subjects will complete the inhaler preference questionnaire (PQ). There is no active treatment and subjects will continue to take their own prescribed COPD medication for the duration of the study. ELLIPTA and DISKUS are registered trademarks of the GSK group of companies; TURBUHALER is a registered trademark of AstraZeneca and HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG.

YES

Pulmonary Disease, Chronic Obstructive

Percentage of Participants Making at Least One Critical Error After Reading the Patient Information Leaflets (PIL), Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. After reading the PIL for each DPI to be tested, participants demonstrated the DPI and critical errors made by the participants while using each DPI were recorded by the Healthcare Professional (HCP) on the checklists provided. Percentage of participants making at least one critical error after reading PIL were reported., Day 1

Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP, Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. After reading PIL for each DPI to be tested, participants demonstrated the DPI and errors made by the participants while using each DPI were recorded by the HCP on the checklists provided. If a participant made errors while demonstrating DPI, HCP provided instruction on the correct use of the DPI. The participant then repeated the demonstration of DPI use, and the HCP recorded the critical errors made on the checklists. Percentage of participants making at least one critical error after the first instruction from the HCP were reported., Day 1|Percentage of Participants Making at Least One Critical Error After the Second Instruction From the HCP, Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. After reading the PIL for each DPI to be tested, participants demonstrated the DPI and errors made by the participants while using each DPI were recorded by the HCP on the checklists provided. If a participant made an error while demonstrating DPI use after first instruction from the HCP, then the HCP provided instructions again on the correct use of the inhaler. The participant then demonstrated the DPI for one last time, and the HCP recorded the critical errors made on the checklists. Participants making at least one critical error after the second instruction from the HCP were reported., Day 1|Percentage of Participants Making at Least One Overall Error After Reading the PIL, Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. Overall error was defined as an error including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL. For each DPI to be tested, overall errors including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL were recorded by the HCP on the checklists provided. Percentage of participants making at least one overall error after reading the PIL were reported., Day 1|Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP, For each DPI to be tested, overall errors including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL following first instruction from the HCP were recorded by the HCP on the checklists provided. Percentage of participants making at least one overall error after the first instruction from the HCP were reported., Day 1|Percentage of Participants Making at Least One Overall Error After the Second Instruction From the HCP, For each DPI to be tested, overall errors including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL following first, and second instruction from the HCP were recorded by the HCP on the checklists provided. Percentage of participants making at least one overall error after the second instruction from the HCP were reported. These statistics are only presented when the model has successfully converged., Day 1|Number of Participants With Instructions (0, 1 or 2 Times) From the HCP Which Are Needed to Demonstrate Correct Inhaler Use, In each sub-study, if the participant made error while demonstrating the use of the DPI after reading the PIL, the HCP demonstrated the correct usage instructions to the participant. The participant was then asked to demonstrate the DPI again. Any errors made were recorded by the HCP, and the same process was repeated one more time. In total, the HCP instructed the participants on the use of the DPI up to two times after which there were no assessment scheduled. Number of participants with instructions (0, 1 or 2) needed to demonstrate correct DPI use by the participants were reported., Day 1|The Median Time to Demonstrate Correct Inhaler Use (T1+T2), For each DPI being tested, the total time taken from when participant started reading the PIL until when correct use was demonstrated (that is the time required to read PIL, and two attempts for correct use of DPI following instructions provided by the HCP ) was recorded. A participant who did not demonstrate correct use at the end of the time period was censored. The median time to demonstrate correct DPI use (minutes) is taken from the Kaplan-Meier analysis. If more than 50% of the data is censored therefore the median is not applicable., Day 1|Time Taken to Read the PIL and Demonstrate Correct Inhaler Use (T1), For each DPI being tested, the time taken from when participant started reading the PIL until when correct use was demonstrated with no need of instructions by HCP was reported. A participant who did not demonstrate correct use at the end of the time period was censored. The median time to demonstrate correct DPI use (minutes) is taken from the Kaplan-Meier analysis. If more than 50% of the data is censored therefore the median is not applicable., Day 1|Time Taken to be Given Instruction by the HCP (up to 2 Times) on Use of the Inhaler and to Demonstrate Correct Inhaler Use (T2), The time in minutes from when the HCP started to instruct participant for the correct use of DPI until correct use was demonstrated including maximum of two attempts only, was recorded. A participant who did not demonstrate correct use at the end of the time period was censored. Participants who demonstrated correct use after reading the PIL (T1) were included with a time of 0 for T2. The median time to demonstrate correct DPI use (minutes) is taken from the Kaplan-Meier analysis. If more than 50% of the data is censored then the median is not applicable. Participants who demonstrated correct use after reading the PIL are included with T2=0., Day 1|Number of Participants With Treatment Preference Based on Responses to the Preference Questionnaire, Which Considered the Number of Steps Required to Take the COPD Medication, Participants demonstrated the use of ELLIPTA, and depending on the substudy DISKUS plus HandiHaler or Turbuhaler plus Handihaler. At the end of Visit 1, participants completed specific versions of the inhaler PQ (PQ1, PQ2, PQ3 or PQ4) according to the questionnaire they were randomized to. Participants assessed the inhaler preference based on the number of steps needed to take the COPD medication. Participants checked the response from the choice of ELLIPTA, DISKUS + HandiHaler (sub-study 1), Turbuhaler + Handihaler (sub-study 2) and No Preference. Number of participants with treatment preference based on responses to the preference questionnaire were reported., Day 1|Number of Participants With Treatment Preference Based on Responses to the Preference Questionnaire, Which Considered Overall Treatment Preference, Participants demonstrated the use of ELLIPTA, and depending on the substudy DISKUS plus HandiHaler or Turbuhaler plus Handihaler. At the end of Visit 1, participants completed specific versions of the inhaler PQ (PQ1, PQ2, PQ3 or PQ4) according to the questionnaire they were randomized to. Participants assessed the inhaler preference based on overall treatment preference. Participants checked the response from the choice of ELLIPTA, DISKUS + HandiHaler (sub-study 1), Turbuhaler + Handihaler (sub-study 2) and No Preference. Number of participants with treatment preference based on responses to the preference questionnaire were reported., Day 1

null

GlaxoSmithKline

null

ALL

ADULT, OLDER_ADULT

PHASE4

160

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT

206215

2016-12-30

2017-06-19

2016-12-05

2019-10-21

GSK Investigational Site, Enschede, 7513 ER, Netherlands|GSK Investigational Site, Nijverdal, 7442 LS, Netherlands|GSK Investigational Site, Rotterdam, 3051 GV, Netherlands|GSK Investigational Site, London, EC1M 6BQ, United Kingdom|GSK Investigational Site, London, NW10 7EW, United Kingdom

Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT02982187/SAP_000.pdf|Study Protocol, https://cdn.clinicaltrials.gov/large-docs/87/NCT02982187/Prot_001.pdf

{ "Placebo ELLIPTA": [ { "intervention_type": "DEVICE" } ], "Placebo DISKUS": [ { "intervention_type": "DEVICE" } ], "Placebo TURBUHALER": [ { "intervention_type": "DEVICE" } ], "Placebo HANDIHALER": [ { "intervention_type": "DEVICE" } ], "PQ1": [ { "intervention_type": "OTHER" } ], "PQ2": [ { "intervention_type": "OTHER" } ], "PQ3": [ { "intervention_type": "OTHER" } ], "PQ4": [ { "intervention_type": "OTHER" } ] }

NCT00700687

Study Evaluating the Effect on Gastroduodenal Mucosa of PA32540, PA32540 and Celecoxib, and Aspirin With Celecoxib

https://clinicaltrials.gov/study/NCT00700687

PA32540-109

COMPLETED

We will evaluate the effect on the gastroduodenal mucosa from oral dosing of three different treatments

NO

Healthy

DRUG: PA32540|DRUG: PA32540 and celecoxib|DRUG: aspirin and [NSAID]

Lanza scores, entire course of study

safety of three treatments, entrie course of study

null

POZEN

null

ALL

ADULT, OLDER_ADULT

PHASE1

90

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE

PA32540-109

2008-06

2008-07

2008-06-19

null

2009-01-12

Anaheim, California, United States

null

{ "PA32540": [ { "intervention_type": "DRUG" } ], "Celecoxib": [ { "intervention_type": "DRUG", "description": "PA32540 and celecoxib", "name": "Celecoxib", "synonyms": [ "SC-58635", "p-(5-p-Tolyl-3-(trifluoromethyl)pyrazol-1-yl)benzenesulfonamide", "Celecoxib", "SC 58635", "Onsenal", "SC58635", "Elyxyb", "Celecoxibum", "Celebrex", "4-(5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide", "C\u00e9l\u00e9coxib" ], "medline_plus_id": "a699022", "generic_names": [ "Celecoxib" ], "mesh_id": "D052246", "drugbank_id": "DB00482", "wikipedia_url": "https://en.wikipedia.org/wiki/Celecoxib" } ], "Aspirin": [ { "intervention_type": "DRUG", "description": "aspirin and [NSAID]", "name": "Aspirin", "synonyms": [ "Valomag", "Endosprin", "Acetysal", "Acetylsalicylic acid", "Azetylsalizyls\u00e4ure", "Magnecyl", "Acetylsalicylic Acid", "2-(Acetyloxy)benzoic Acid", "Aloxiprimum", "Polopirin", "Bonjela", "Acetylsalicylate", "Dispril", "Ecotrin", "Acylpyrin", "Acid, Acetylsalicylic", "Anadin", "Zorprin", "Polopiryna", "Solupsan", "Colfarit", "Solprin", "Micristin", "Easprin", "Aspirin", "Boots Haemorrhoid", "2-(Diethylamino)-2',6'-acetoxylidide", "2-2EtN-2MePhAcN", "\u03b1-diethylamino-2,6-dimethylacetanilide", "Xylocaine", "Lidocaine Monohydrochloride, Monohydrate", "Lidocaine Carbonate", "Xyloneural", "2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide", "Ztlido", "EMLA", "Lidocaina", "Lidocaine", "2-(Diethylamino)-N-(2,6-Dimethylphenyl)Acetamide", "Covonia", "Xylopract", "Nulbia", "Lidoca\u00edna", "Octocaine", "Lidocainum", "LMX4", "Bonjela", "Lidocaine Hydrochloride", "Dalcaine", "Lidocaine Sulfate (1:1)", "Anbesol", "Perinal", "Anusol", "Lidocaine Monohydrochloride", "Germaloids", "Iglu", "Xylesthesin", "Lidocaine Monoacetate", "Lignocaine", "Calgel", "Lidocaine Carbonate (2:1)", "Denela", "Lidocaine Hydrocarbonate", "alpha-diethylamino-2,6-dimethylacetanilide", "Xylocitin", "Dermalid", "Ztlido", "Lidoderm", "Absorbine Jr", "Lidocaine Patch", "Dermalid", "Ztlido", "Lidoderm", "Absorbine Jr", "Lidocaine Patch", "Xylocaine", "Lidocaine Viscous", "Xylocaine", "Lidocaine Viscous", "Senstend", "Emla", "Fortacin", "Lidocaine/prilocaine", "Boots Haemorrhoid", "2-(Diethylamino)-2',6'-acetoxylidide", "2-2EtN-2MePhAcN", "\u03b1-diethylamino-2,6-dimethylacetanilide", "Xylocaine", "Lidocaine Monohydrochloride, Monohydrate", "Lidocaine Carbonate", "Xyloneural", "2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide", "Ztlido", "EMLA", "Lidocaina", "Lidocaine", "2-(Diethylamino)-N-(2,6-Dimethylphenyl)Acetamide", "Covonia", "Xylopract", "Nulbia", "Lidoca\u00edna", "Octocaine", "Lidocainum", "LMX4", "Bonjela", "Lidocaine Hydrochloride", "Dalcaine", "Lidocaine Sulfate (1:1)", "Anbesol", "Perinal", "Anusol", "Lidocaine Monohydrochloride", "Germaloids", "Iglu", "Xylesthesin", "Lidocaine Monoacetate", "Lignocaine", "Calgel", "Lidocaine Carbonate (2:1)", "Denela", "Lidocaine Hydrocarbonate", "alpha-diethylamino-2,6-dimethylacetanilide", "Xylocitin", "Dermalid", "Ztlido", "Lidoderm", "Absorbine Jr", "Lidocaine Patch", "Dermalid", "Ztlido", "Lidoderm", "Absorbine Jr", "Lidocaine Patch", "Xylocaine", "Lidocaine Viscous", "Xylocaine", "Lidocaine Viscous", "Senstend", "Emla", "Fortacin", "Lidocaine/prilocaine" ], "medline_plus_id": "a621021", "generic_names": [ "Acetylsalicylic acid", "Aspirin", "Lidocaine", "Lidocaine Patch", "Lidocaine Patch", "Lidocaine Viscous", "Lidocaine Viscous", "Lidocaine", "Lidocaine Patch", "Lidocaine Patch", "Lidocaine Viscous", "Lidocaine Viscous" ], "nhs_url": "https://www.nhs.uk/medicines/aspirin-for-pain-relief", "mesh_id": "D058633", "drugbank_id": "DB00945", "wikipedia_url": "https://en.wikipedia.org/wiki/Aspirin" } ] }

NCT01518387

Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients

https://clinicaltrials.gov/study/NCT01518387

null

COMPLETED

The purpose of this study is to assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing continuous ambulatory peritoneal dialysis.

NO

Hyperphosphatemia

DRUG: Lanthanum Carbonate (BAY77-1931)

Change from baseline in serum phosphate levels at the end of the treatment period, Baseline to Week 8

Number of participants achieving the target PSPL (Pre-dialysis serum phosphate level) and time to achievement, Week 8|Serum calcium level corrected by serum albumin level at the end of the treatment period, Week 8|Serum calcium x phosphate product at the end of the treatment period, Week 8|Serum intact-PTH (Parathyroid) levels at the end of the treatment period, Week 8|Safety variables will be summarized using descriptive statistics based on adverse events collection, 8 weeks

null

Bayer

null

ALL

ADULT, OLDER_ADULT

PHASE3

43

INDUSTRY

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

11878

2006-01

2006-07

2012-01-26

null

2016-03-14

null

{ "Lanthanum Carbonate (BAY77-1931)": [ { "intervention_type": "DRUG" } ] }

NCT06000787

MCT for the Harvard/UCSF ROBIN Center

https://clinicaltrials.gov/study/NCT06000787

null

RECRUITING

The goal of the Molecular Characterization Trial (MCT) is to obtain biological specimens and data resources from patients enrolled on prospective trials, to ensure that the Harvard/UCSF ROBIN Center accomplishes its key objective of advancing our understanding of the biological mechanisms that underlie how radiation treats tumors but also can cause unwanted side effects. The MCT focuses on collection of research biospecimens before, during, and after radiation. Also critical to the MCT is the deep annotation of these research biospecimens with elements that complement each other to provide a holistic, detailed view of each patient. Annotated elements include those used in the past such as clinical and biological features but extend to factors we have so far neglected but must incorporate in the future such as dosimetry (precise anatomical measurement of radiation dose), artificial intelligence, computational biology, and natural language processing.

NO

Glioma, Childhood Brainstem|Neuroblastoma

RADIATION: External beam radiotherapy|RADIATION: 131I-Metaiodobenzylguanidine (MIBG)

Event-free survival by tumor heterogeneity, EFS is calculated from the date of treatment assignment to the first episode of disease relapse or progression, second malignancy, or death, or until last contact if no event has occurred. This will be compared in participants with tumors showing high versus low tumor heterogeneity assessed quantitatively based on single-cell RNA sequencing., up to 3 years|Event-free survival by DNA damage response, EFS is calculated from the date of treatment assignment to the first episode of disease relapse or progression, second malignancy, or death, or until last contact if no event has occurred. This will be compared in participants with tumors showing intact versus defective responses to treatment-induced DNA damage determined by immunohistochemistry and microRNA profiling., up to 3 years|Event-free survival by tumor DNA alterations, EFS is calculated from the date of treatment assignment to the first episode of disease relapse or progression, second malignancy, or death, or until last contact if no event has occurred. This will be compared in participants with tumors showing presence or absence of point mutations and copy number alterations detected in tumor tissue or circulating cell-free DNA., up to 3 years

Proportion of patients with serious adverse events by DNA damage response, Serious adverse events will be defined as one or more Grade 3 or higher toxicities during protocol therapy graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, or meeting protocol-specified criteria for dose-limiting toxicities. This will be compared in participants with blood samples showing intact versus defective responses to treatment-induced DNA damage determined by immunohistochemistry and microRNA profiling., up to 18 months

null

Brigham and Womens Hospital

Dana-Farber Cancer Institute|National Cancer Institute (NCI)|University of California, San Francisco

ALL

CHILD, ADULT, OLDER_ADULT

null

47

OTHER

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE

2023P002087|U54CA274516

2023-09-19

2028-08-31

2023-08-21

null

2023-12-12

University of California, San Francisco, San Francisco, California, 94143, United States|Brigham and Womens Hospital, Boston, Massachusetts, 02115, United States

null

{ "External beam radiotherapy": [ { "intervention_type": "RADIATION" } ], "131I-Metaiodobenzylguanidine (MIBG)": [ { "intervention_type": "RADIATION" } ] }

NCT05614687

Art as Healing: A Community-informed Art-based Programme (CiAbP) for Reintegrating Ex-offenders Into Society in Nigeria

https://clinicaltrials.gov/study/NCT05614687

null

NOT_YET_RECRUITING

The goal of this pilot experimental study is to test a community-informed art-based programme in improving community members trauma from crime and to aid the reintegration of ex-offenders into society. The main question it aims to answer are: • What is the feasibility in terms of recruitment, retention, adherence to the intervention and communities/victims satisfaction with CiAbP to promote healing and improve the successful reintegration of ex-offenders into society? Participants will be randomly allocated into two groups. The first group, the intervention group, will receive the Community-informed Art-based programme (CiAbP). The second group will receive government intervention involving media messages from the National Orientation Agency devoid of CiAbP. The CiAbP. sessions will cover relevant aspects of art, such as photo story, story telling, poetry, and drawing in tackling trauma and negative attitudes towards ex-offenders reintegration. Researchers will compare CiAbP group with the media orientation group to see if there are differences between a change in attitude towards ex-offenders reintegration at base line, end of intervention and three months follow up.

NO

Trauma|Depression|Anxiety and Fear

BEHAVIORAL: Community-informed art-based programme|OTHER: Government Media Intervention

Trauma Screening Questionnaire, Change in traumatic experience is being assessed Change in traumatic experience is being assessed Change in traumatic experience is being assessed, Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention|Belief in Redeemability Scale v2, Change in of attitude towards ex-offenders reintegration is being assessed, Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention|Service Satisfaction Scale, Change in service satisfaction is being assessed, Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention

null

Teesside University

null

ALL

ADULT, OLDER_ADULT

null

60

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

0000-0003-0516-0313b

2023-09-01

2024-12-31

2026-08-30

2022-11-14

null

2022-11-23

null

{ "Community-informed art-based programme": [ { "intervention_type": "BEHAVIORAL" } ], "Government Media Intervention": [ { "intervention_type": "OTHER" } ] }

NCT03353987

Preoperative Cognitive Training for Postoperative Cognitive Dysfunction

https://clinicaltrials.gov/study/NCT03353987

CogniTrain

TERMINATED

Postoperative Cognitive Dysfunction (POCD) is a state of decline in cognitive ability after surgery and is frequently seen among our elderly population. Many studies have looked into predictive risk factors for POCD while research is underway to search for pre-emptive measures to avoid this unfavourable outcome. Most will be looking at utilizing mobile software applications of cognitive training but in many poorer countries, owning electronic devices may not be an option or may be culturally less acceptable among the older patients. Hence, the investigators intend to investigate if a home-based logbook for cognitive training will reduce the incidence of POCD in a single centre study.

NO

Cognitive Decline|Cognitive Impairment|Cognitive Deterioration

BEHAVIORAL: Cognitive training

Postoperative cognitive dysfunction, Any patient having deficit in 2 or more neuropsychological tests will be deemed to have POCD. A deficit in any test will be defined as a negative difference in scores and if the absolute value of each of these change scores is larger than one standard deviation (SD) of the baseline in the same cognitive test from all subjects. Any patient having deficit in 2 or more neuropsychological tests., One week after surgery|Postoperative cognitive dysfunction, Any patient having deficit in 2 or more neuropsychological tests will be deemed to have POCD. A deficit in any test will be defined as a negative difference in scores and if the absolute value of each of these change scores is larger than one standard deviation (SD) of the baseline in the same cognitive test from all subjects. Any patient having deficit in 2 or more neuropsychological tests., One year after surgery

Identify age as a risk factor for developing POCD, Correlation between patient age (in years) to POCD (Any patient having deficit in 2 or more neuropsychological tests will be deemed to have POCD. A deficit in any test will be defined as a negative difference in scores and if the absolute value of each of these change scores is larger than one standard deviation (SD) of the baseline in the same cognitive test from all subjects. Any patient having deficit in 2 or more neuropsychological tests.), One week and 1 year after surgery|Identify the association between types of surgery performed with developing POCD, Correlation between surgical procedures (orthopaedic/ general surgery/ ENT/ gynaecology) to POCD (Any patient having deficit in 2 or more neuropsychological tests will be deemed to have POCD. A deficit in any test will be defined as a negative difference in scores and if the absolute value of each of these change scores is larger than one standard deviation (SD) of the baseline in the same cognitive test from all subjects. Any patient having deficit in 2 or more neuropsychological tests.), One week and 1 year after surgery|Identify the association between duration of anaesthesia with developing POCD, Correlation between duration of anaesthesia (hours) to POCD (Any patient having deficit in 2 or more neuropsychological tests will be deemed to have POCD. A deficit in any test will be defined as a negative difference in scores and if the absolute value of each of these change scores is larger than one standard deviation (SD) of the baseline in the same cognitive test from all subjects. Any patient having deficit in 2 or more neuropsychological tests.), One week and 1 year after surgery|Duration of home based cognitive training to prevent POCD, Analysis of correlation between the total duration of cognitive training (hours) and incidence of POCD (Any patient having deficit in 2 or more neuropsychological tests will be deemed to have POCD. A deficit in any test will be defined as a negative difference in scores and if the absolute value of each of these change scores is larger than one standard deviation (SD) of the baseline in the same cognitive test from all subjects. Any patient having deficit in 2 or more neuropsychological tests., One week and 1 year after surgery|Correlation between delirium and POCD, Analysis of correlation between positive CAM tests and incidence of POCD (Any patient having deficit in 2 or more neuropsychological tests will be deemed to have POCD. A deficit in any test will be defined as a negative difference in scores and if the absolute value of each of these change scores is larger than one standard deviation (SD) of the baseline in the same cognitive test from all subjects. Any patient having deficit in 2 or more neuropsychological tests.), Post-op Day 1 to 3

null

University of Malaya

null

ALL

OLDER_ADULT

null

17

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION

2017312-5034

2018-01-01

2019-05-31

2017-11-27

null

2019-08-05

University Malaya, Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, 50603, Malaysia

null

{ "Cognitive training": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT06265987

Maternal and Fetal Characteristics Influencing Image Quality in Prenatal Ultrasonography

https://clinicaltrials.gov/study/NCT06265987

null

COMPLETED

The objective of this observational study is to identify maternal and fetal characteristics that impact image quality in prenatal ultrasonography. The investigators have assembled a retrospective cohort of 198 patients, each contributing three ultrasound images taken between 18 and 18 weeks and 6 days of gestation. For each image, the investigators assess the quality of two distinct elements as well as the overall image through both subjective and objective evaluations. The primary questions the study seeks to address are: What maternal and fetal characteristics influence image quality in prenatal ultrasonography?

NO

Ultrasonography|Obstetrics|Fetus|Pregnant Women

null

Maternal and fetal characteristics can influence quality image in ultrasonography, Baseline

null

Poitiers University Hospital

null

FEMALE

ADULT, OLDER_ADULT

null

198

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

ECHOQUALITY2

2023-08-01

2024-01-01

2024-01-31

2024-02-20

null

2024-02-20

University Hospital La MILETRIE, Poitiers, 86000, France

null

{}

NCT02697487

UTSW Depression Cohort: A Longitudinal Study of Depression

https://clinicaltrials.gov/study/NCT02697487

null

COMPLETED

This is a longitudinal observational study (via electronic records and biospecimens) designed to utilize health IT advances to collect information from patients undergoing routine care. This information will be stored in a database. Patients undergoing routine care from their providers will be invited to participate in the UTSW Depression Cohort. After obtaining informed consent, the CDRCC team will collect information from available sources and store it in a secure UT Southwestern network database protected by a security firewall. A schematic representation of this information processing is shown in the figure contained in section 3 of the protocol. As part of the UTSW Depression Cohort, patients will allow banking of their specimens. Specimens which are banked may include blood or blood products, urine, tissue samples, saliva, stool samples or clinical waste products. The study will only enroll participants comfortable with providing specimens. As the goal of the UTSW Depression Cohort is to create a national database, CDRCC will engage with patients, providers, and researchers at local, regional, and national levels. A large number of medical providers are already screening patients for depression. Structured instruments like PHQ-2 or PHQ-9 are often used. Hence, the CDRCC will seek collaborations with local, regional and national partners so that information contained in their health IT initiatives can be included in the this database. Due to the clinical nature of information collected, the investigators anticipate marked heterogeneity in the variables and amount of data collected. Database architects will utilize big data (large volumes of information from diverse sources with variable degrees of quality and complexity) tools to structure the registry so that additional variables can be added, as needed. The CDRCC team will maintain a detailed codebook of variables collected in the database. All statistical analyses will be conducted only on de-identified data. Researchers may obtain access to this de-identified data by following procedures established by the CDRCC, which include obtaining IRB approval.

NO

Depression|Other Diagnoses, Comorbidities, and Complications

OTHER: No treatment

Changes in depression severity as measured by 9-item Patient Health Questionnaire, Changes in depression severity will be measured by 9-item Patient Health Questionnaire. PHQ-9 score ranges from 0-27, higher score indicates sever depression. Minimal depression 0-4 Mild depression 5-9 Moderate depression 10-14 Moderately severe depression 15-19 Severe depression 20-27, Change from Baseline to 10 years

Changes in functioning as measured by 5-item Work Social Adjustment Scale in participants with and without depression., Changes in functioning will be measured by 5-item Work Social Adjustment Scale (WSAS).5-item Work Social Adjustment Scale ranges from 0 to 40. WSAS Score >20 appears to suggest moderately severe or worse psychopathology Scores between 10 and 20 are associated with significant functional impairments but less severe clinical symptomatology. Scores <10 appear to be associated with subclinical population, Change from Baseline to 10 years

null

University of Texas Southwestern Medical Center

null

ALL

CHILD, ADULT, OLDER_ADULT

null

447

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

STU 092015-049

2016-02

2018-03-22

2016-03-03

null

2023-11-07

University of Texas Southwestern Medical Center, Dallas, Texas, 75390, United States

null

{ "No treatment": [ { "intervention_type": "OTHER" } ] }

NCT03954587

What is the Optimal Cycle Regimen for Frozen- Thawed Embryo Transfer Cycles

https://clinicaltrials.gov/study/NCT03954587

null

TERMINATED

Investigators will be comparing artificial (HRT) frozen-thawed embryo transfer cycles to correctly conducted spontaneous natural cycles after the transfer of a chromosomally normal embryo.

NO

Infertility|Female Infertility|Pregnancy Early

null

Ongoing pregnancy rate to 8 weeks gestation, viable pregnancy to 8 gestational weeks, 8 weeks|Pregnancy rate beta human chorionic gonadotropin (ß-hCG) > 5 IU, Number of patients with a hCG > 5 IU out of the number of patients who underwent an embryo transfer with one or two euploid embryos, 12 days|Biochemical pregnancy rate, Positive ß-hCG, but at 5 gestational weeks no ultrasonographic visible gestational sac seen, 5 weeks|Clinical implantation rate, Number of gestational sacs observed by ultrasound at 6 weeks of gestation divided by the number of embryos transferred, 6 weeks|Clinical pregnancy rate, Ultrasonographic visible sac at 5 gestational weeks, 5 weeks

null

ART Fertility Clinics LLC

null

FEMALE

ADULT

null

4

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

1901-ABU-015-CC

2019-06-10

2020-07-15

2020-07-30

2019-05-17

null

2021-03-08

IVI Middle East Fertility Clinic, Abu Dhabi, 60202, United Arab Emirates

null

{}

NCT03147287

Palbociclib After CDK and Endocrine Therapy (PACE)

https://clinicaltrials.gov/study/NCT03147287

null

ACTIVE_NOT_RECRUITING

This research study is studying three combinations of drugs as treatments for breast cancer. The drugs involved in this study are: * Fulvestrant * Fulvestrant with Palbociclib * Fulvestrant with Palbociclib and Avelumab

YES

Metastatic Breast Cancer

DRUG: Palbociclib|DRUG: Fulvestrant|DRUG: Avelumab

Progression-Free Survival (PFS), According to RECIST v1.1 Criteria (Investigator Assessment), Progression-Free Survival (PFS), according to RECIST v1.1 criteria (investigator assessment): the time from randomization to the earlier of progression or death due to any cause. Participants alive without disease progression were censored at date of last disease assessment (tumor assessments). The date of progression was the first date that recurrent or progressive disease was objectively documented; if death was the defining event, it must have happened within 2 intervals of the last disease assessment, otherwise PFS was censored at last disease assessment. The length of PFS was calculated as PFS time (months) =[progression/death date(censor date) - randomization date + 1]/30.4375., Tumor were assessed every 8 weeks until 24 weeks, then every 12 weeks. The median PFS follow-up time at database lock was 12.1 months (range 1 day to 50.1 months).

Overall Response Rate, According to RECIST v1.1 Criteria (Investigator Assessment), Objective Response (OR): best overall response of complete response or partial response. Response was primarily evaluated in this study using the criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). For example, target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. See RECIST 1.1 manuscript for further details on overall assessment based on target lesions, non-target lesions and new lesions. The Overall Response Rate (with 2-sided 90% CIs) were estimated according to treatment assignment and subgroup., Tumor were assessed every 8 weeks until 24 weeks, then every 12 weeks. The median follow-up time for overall response rate at database lock was 12.1 months (range 1 day to 50.1 months).|Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability), The frequency (and %) of patients who are reported as having grade 3-5 treatment-related adverse events were summarized. From starting the first dose of study treatment to 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported., The median follow-up time for adverse event was 5.4 months (range 1.6 months to 51.2 months).

null

Dana-Farber Cancer Institute

Pfizer

ALL

ADULT, OLDER_ADULT

PHASE2

220

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

17-101

2017-09-05

2022-12-31

2024-12-31

2017-05-10

2023-12-12

2024-01-11

University of Miami, Miami, Florida, 33136, United States|Emory University - Winship Cancer Institute, Atlanta, Georgia, 30322, United States|Northwestern University, Chicago, Illinois, 60611, United States|Indiana University, Indianapolis, Indiana, 46202, United States|The University of Kansas Cancer Center - North, Kansas City, Kansas, 64154, United States|The University of Kansas Cancer Center - Overland Park, Overland Park, Kansas, 66210, United States|The University of Kansas Cancer Center, Westwood, Kansas, 66205, United States|University of Louisville, Louisville, Kentucky, 40202, United States|Eastern Maine Medical Center, Bangor, Maine, 04401, United States|Boston Medical Center, Boston, Massachusetts, 02188, United States|Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States|Dana-Farber at St. Elizabeths Medical Center, Brighton, Massachusetts, 02135, United States|DF/BWCC at Milford Regional Medical Center, Milford, Massachusetts, 01757, United States|DF/BWCC in clinical affiliation with South Shore Hospital, South Weymouth, Massachusetts, 02190, United States|The University of Kansas Cancer Center - Lees Summit, Lees Summit, Missouri, 64064, United States|Washington University, Saint Louis, Missouri, 63110, United States|Dana-Farber/New Hampshire Oncology-Hematology, Londonderry, New Hampshire, 03053, United States|University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States|Baylor University, Houston, Texas, 77030, United States|Aurora Cancer Care, Milwaukee, Wisconsin, 53215, United States

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT03147287/Prot_SAP_000.pdf

{ "Palbociclib": [ { "intervention_type": "DRUG", "description": "Palbociclib", "name": "Palbociclib", "synonyms": [ "6-acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one", "Ibrance", "Palbociclib" ], "medline_plus_id": "a615013", "generic_names": [ "Palbociclib" ], "drugbank_id": "DB09073" } ], "Fulvestrant": [ { "intervention_type": "DRUG", "description": "Fulvestrant", "name": "Fulvestrant", "synonyms": [ "ICI 182,780", "7-(9-(4,4,5,5,5-pentafluoropentylsulfinyl)nonyl)estra-1,3,5(10)-triene-3,17-diol", "ICI 182780", "ZM 182780", "ICI-182780", "ZM-182780", "ZM182780", "(7\u03b1,17\u03b2)-7-{9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl}estra-1(10),2,4-triene-3,17-diol", "ICI182780", "Fulvestrant", "Faslodex" ], "medline_plus_id": "a607031", "generic_names": [ "Fulvestrant" ], "mesh_id": "D065171", "drugbank_id": "DB00947" } ], "Avelumab": [ { "intervention_type": "DRUG", "description": "Avelumab", "name": "Avelumab", "synonyms": [ "Bavencio", "Avelumab" ], "medline_plus_id": "a617006", "generic_names": [ "Avelumab" ], "drugbank_id": "DB11945", "wikipedia_url": "https://en.wikipedia.org/wiki/Avelumab" } ] }

NCT00999687

Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract on Psoriatic Nails

https://clinicaltrials.gov/study/NCT00999687

null

COMPLETED

The purpose of this study is to evaluate efficacy and safety of indigo naturalis oil extract in treating nail psoriasis.

YES

Nail Psoriasis

DRUG: Indigo Naturalis Extract in Oil|OTHER: Olive Oil

Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 12., The nail is divided by imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. The NAPSI score evaluates presence of signs in the nail bed (of onycholysis, splinter hemorrhages, nail bed discoloration, and subungual hyperkeratosis) and on the nail matrix (pitting, leukonychia, red spots in the lunula and nail plate crumbling) in all 10 fingernails, providing a minimal score of 0 and a maximum of 80. This study is an intra-patient side-to-side comparison, it measures nail disease on a single hand. All 5 fingers in each group were scored providing a maximum score of 40 and a minimal of 0. The modified target NAPSI score for the target nail scores severity of nail matrix and nail-bed psoriasis from 0 (no sign) to 3 (severe involvement) in each nail quadrant, providing a maximum score of 96 and a minimal of 0., Baseline and Week 12|Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 24., The nail is divided by imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. The NAPSI score evaluates presence of signs in the nail bed (of onycholysis, splinter hemorrhages, nail bed discoloration, and subungual hyperkeratosis) and on the nail matrix (pitting, leukonychia, red spots in the lunula and nail plate crumbling) in all 10 fingernails, providing a minimal score of 0 and a maximum of 80. This study is an intra-patient side-to-side comparison, it measures nail disease on a single hand. All 5 fingers in each group were scored providing a maximum score of 40 and a minimal of 0. The modified target NAPSI score for the target nail scores severity of nail matrix and nail-bed psoriasis from 0 (no sign) to 3 (severe involvement) in each nail quadrant, providing a maximum score of 96 and a minimal of 0., Baseline and Week 24

null

Chang Gung Memorial Hospital

null

ALL

ADULT, OLDER_ADULT

PHASE2|PHASE3

31

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

CMRPG280191

2009-09

2010-09

2009-10-22

2012-09-12

2019-08-07

null

{ "Indigo Naturalis Extract in Oil": [ { "intervention_type": "DRUG" } ], "Olive Oil": [ { "intervention_type": "OTHER" } ] }

NCT05290987

Efficacy of ADW S-100 Ionized Water Nasal Spray in Decreasing SARS-Cov-2 Viral Load.

https://clinicaltrials.gov/study/NCT05290987

null

TERMINATED

A nasal spray based on Advanced Water S-100 ionized water would clean the nasal cavity, reduce the viscosity of the mucus and facilitate its elimination and the decongestion of the nose and the prevention of the seizure of the SARS-COV-2 to the epithelial cells of the nasal cavity In fact, a nasal spray based on Advanced Water S-100 ionized water would modify the electrostatic environment of all interactions ensuring this seizure. The negative ions (OH-) contained in Advanced Water S-100 compete with the negative ions of the heparan sulfate, which will destabilize this essential bond for the virus to enter the host cell. In addition, positively charged basic amino acids, in the presence of the basic pH of ADW S-100, will be neutralized by OH- ions which will prevent the formation of salt and hydrogen bridges mediating the formation of the protein S/ACE2 complex. The destabilization of all bonds governing the protein S/ACE2 association process will prevent the virus from entering cells and replicating. The aim of this study is to evaluate whether the use of ADW S-100 ionized water nasal spray reduces the salivary and nasopharyngeal viral load during an 8-day follow-up of persons recently infected with SARS-Cov-2, and thus potentially decreases the risk of contamination of the entourage.

NO

SARS-CoV-2 Infection

DEVICE: nasal spray

To determine whether, compared to placebo, ADW S-100 ionized water administered as a nasal spray more rapidly negatively affects the viral load of individuals infected with SARS-CoV-2, % of participants negative at D4 (Ct≥35), 8 days

null

P & B Group

MediAxe CRO

ALL

ADULT, OLDER_ADULT

null

13

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION

2021-A01861-40

2022-01-14

2022-11-08

2022-03-22

null

2022-11-17

Dr Bouviers Office, Aix-en-Provence, 13100, France

null

{ "nasal spray": [ { "intervention_type": "DEVICE" } ] }

NCT02532387

Outpatient Treatment of PE and DVT in the Emergency Department

https://clinicaltrials.gov/study/NCT02532387

null

COMPLETED

Standardize the approach to outpatient Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT) treatment.

NO

Pulmonary Embolism|Deep Vein Thrombosis

OTHER: Telephone follow-up

Efficiency & cost of clinical protocol, To compare patients diagnosed with VTE after protocol implementation to those diagnosed with VTE prior to protocol implementation in terms of four measures of efficiency: A) ED length of stay - defined as time from ED registration to departure from the ED (to either the inpatient floor or to the EDOU). B) ED disposition time - defined as time from ED registration to bed request. C) Hospital length of stay - defined as time from ED registration to departure from the hospital. D) Cost - defined as the estimated cost of care including diagnostic testing, imaging, hospital inpatient/observation unit stay, medication/pharmacy costs., Up to 30 days|Safety of clinical protocol, To assess the safety of outpatient VTE treatment, specifically with regards to: A) recurrent venous thromboembolism; B) bleeding (major or minor); C) unscheduled return to hospital for any reason; D) death from any cause: occurring up to 30 days after their discharge., Up to 30 days

null

Massachusetts General Hospital

null

ALL

ADULT, OLDER_ADULT

null

400

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2015P000877

2015-08

2017-02

2015-08-25

null

2019-03-06

Massachusetts General Hospital, Boston, Massachusetts, 02114, United States|Brigham and Womens Hospital, Boston, Massachusetts, 02115, United States

null

{ "Telephone follow-up": [ { "intervention_type": "OTHER" } ] }

NCT01271387

Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic Impairment

https://clinicaltrials.gov/study/NCT01271387

null

COMPLETED

The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon (including its breakdown products) in the blood in individuals with mild or moderate liver disease compared to individuals who have normal liver function.

NO

Hepatic Impairment

DRUG: tasimelteon

Plasma concentrations and PK of tasimelteon, To assess plasma concentrations and pharmacokinetics of tasimelteon in subjects with mild or moderate hepatic impairment compared to healthy subjects with normal hepatic function., 36 hours

Plasma concentrations and PK of tasimelteon metabolites, To assess plasma concentrations and pharmacokinetics of tasimelteon metabolites in subjects with mild or moderate hepatic impairment compared to healthy subjects with normal hepatic function., 36 hours|Safety, To assess the safety and tolerability of a single 20-mg oral dose of tasimelteon., 36 hours

null

Vanda Pharmaceuticals

null

ALL

ADULT, OLDER_ADULT

PHASE1

29

INDUSTRY

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE

VP-VEC-162-1105

2011-01

2011-08

2011-01-06

null

2014-02-17

Orlando Clinical Research Center, Orlando, Florida, 32809, United States

null

{ "Tasimelteon": [ { "intervention_type": "DRUG", "description": "tasimelteon", "name": "Tasimelteon", "synonyms": [ "Tasimelte\u00f3n", "Tasimelt\u00e9on", "N-{[(1R,2R)-2-(2,3-dihydro-1-benzofuran-4-yl)cyclopropyl]methyl}propanamide", "Tasimelteon", "Tasimelteonum", "Hetlioz" ], "medline_plus_id": "a615004", "generic_names": [ "Tasimelteon" ], "drugbank_id": "DB09071" } ] }

NCT01812187

Designing a Mobile App for Veterans With Substance Use Problems

https://clinicaltrials.gov/study/NCT01812187

null

UNKNOWN

The purpose of this study is to increase access for rural Veterans to evidence-based, person-centered, individually tailored treatment for alcohol use problems. The primary aim is to evaluate the acceptability and feasibility of using mobile technology deliver treatment for alcohol use disorder. A mobile application will be used replacing the usual setting of clinical visits that accompanies standard face-to-face CBT therapy. The application will be loaded onto an iPod, which will be distributed to each participant that has been found to be eligible to participate.

NO

Substance Abuse Problem|Alcohol Abuse|Alcohol Dependence

BEHAVIORAL: SHIFT Cognitive Behavioral Therapy

Change, Change from baseline AUDIT score at 3 months

null

Michael E. DeBakey VA Medical Center

null

ALL

ADULT

null

20

FED

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

H-30374

2015-04

2017-05

2013-03-18

null

2015-09-23

Michael E. DeBakey VA Medical Center, Houston, Texas, 77545, United States

null

{ "SHIFT Cognitive Behavioral Therapy": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT03582787

A Comparison of McGrath MAC Videolaryngoscopy and Macintosh Laryngoscopy for Orotracheal Intubation in Children With Torticollis

https://clinicaltrials.gov/study/NCT03582787

null

COMPLETED

The primary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on the intubation time for orotracheal intubation in children with torticollis. The secondary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on Cormack and Lehane Grade for orotracheal intubation in children with torticollis.

NO

Anesthesia, Endotracheal

DEVICE: McGrath MAC videolaryngoscopy|DEVICE: Macintosh Laryngoscopy

Intubation time, Time interval between laryngoscopy passing the teeth to the confirming of end tidal CO2, through intubation completion, an average of 30 second

The degree of glottic exposure as assessed by Cormack and Lehane Grade, Grade 1: full view of glottis, grade 2: Partial view of glottis, grade 3:only epiglottis seen, grade 4:neither glottis nor epiglottis seen, Up to 5 second after laryngoscopy passing the teeth

null

Ajou University School of Medicine

null

ALL

CHILD

null

30

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION

AJIRB-MED-OBS-18-106

2018-05-31

2019-05-25

2018-07-11

null

2019-07-05

Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, Suwon, Seoum, Korea, Republic of

null

{ "McGrath MAC videolaryngoscopy": [ { "intervention_type": "DEVICE" } ], "Macintosh Laryngoscopy": [ { "intervention_type": "DEVICE" } ] }

NCT06311487

Time and Nutrient-Dependent Effects of Aerobic Exercise on Metabolism in Adults (TANDEM Study)

https://clinicaltrials.gov/study/NCT06311487

TANDEM

RECRUITING

This study plans to learn more about metabolic responses to aerobic exercise at different times of the day (morning or evening) under fasting versus fed conditions.

NO

Overweight and Obesity|Healthy

BEHAVIORAL: Fasted-AM|BEHAVIORAL: Fed-AM|BEHAVIORAL: Fasted-PM|BEHAVIORAL: Fed-PM

Exercise Energy Expenditure (kcals), On Day 5 of each condition, participants will complete a 45-minute exercise test on the treadmill to compare exercise energy expenditure and fat oxidation between. O2 and CO2 content of expired air will be measured continuously by open circuit spirometry and averaged every minute using an automated online system (TrueMax 2400; Parvo-Medics, Sandy, UT). Exercise energy expenditure will be determined from minute-by-minute values, measured in kcals., Fasted-AM Day 5, Fed-AM Day 5, Fasted-PM Day 5, Fed-PM Day 5|Substrate Oxidation (Respiratory Quotient), On Day 5 of each condition, participants will complete a 45-minute exercise test on the treadmill to compare exercise energy expenditure and fat oxidation between. O2 and CO2 content of expired air will be measured continuously by open circuit spirometry and averaged every minute using an automated online system (TrueMax 2400; Parvo-Medics, Sandy, UT). Substrate Oxidation will be determined from minute-by-minute values, measured in respiratory quotient., Fasted-AM Day 5, Fed-AM Day 5, Fasted-PM Day 5, Fed-PM Day 5

null

University of Colorado, Denver

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

ALL

ADULT

null

20

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER

23-1388|1R56DK136601-01

2024-04-15

2025-08

2024-03-15

null

2024-05-23

University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States

null

{ "Fasted-AM": [ { "intervention_type": "BEHAVIORAL" } ], "Fed-AM": [ { "intervention_type": "BEHAVIORAL" } ], "Fasted-PM": [ { "intervention_type": "BEHAVIORAL" } ], "Fed-PM": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT03066687

A Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Participants

https://clinicaltrials.gov/study/NCT03066687

null

COMPLETED

The primary purpose of this study is to evaluate the effect of food on the relative bioavailability of a single 9 milligram (mg) oral dose of erdafitinib in healthy participants.

NO

Healthy

DRUG: Erdafitinib

Maximum Observed Plasma Concentration (Cmax), The Cmax is the maximum observed plasma concentration., Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144, 192, 240, 288, and 366 hours post dose|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]), The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time., Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144, 192, 240, 288, and 366 hours post dose|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]), The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant., Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144, 192, 240, 288, and 366 hours post dose

Number of Participants With Adverse Events, Safety and Tolerability, Baseline, up to end of study (Day 15 of Period 2) or early withdrawal

null

Janssen Research & Development, LLC

Celerion

ALL

ADULT

PHASE1

16

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER

CR108289|42756493EDI1006

2017-03-14

2017-05-12

2017-02-28

null

2017-06-23

Celerion, Lincoln, Nebraska, 68502, United States

null

{ "Erdafitinib": [ { "intervention_type": "DRUG", "description": "Erdafitinib", "name": "Erdafitinib", "synonyms": [ "Erdafitinib", "Balversa" ], "medline_plus_id": "a619031", "generic_names": [ "Erdafitinib" ], "drugbank_id": "DB12147", "wikipedia_url": "https://en.wikipedia.org/wiki/Erdafitinib" } ] }

NCT03256487

Intravenous Buprenorphine Versus Morphine for Severe Pain in the Emergency Department

https://clinicaltrials.gov/study/NCT03256487

null

UNKNOWN

This study evaluates intravenous (IV) buprenorphine versus IV morphine for the management of severe, acute pain among emergency department (ED) patients. ED patients with severe pain will be randomized in equal proportion to receive IV buprenorphine or IV morphine.

NO

Pain

DRUG: Buprenorphine|DRUG: Morphine Sulfate

Pain score difference at 60 minutes, The difference in pain scores (measured by NRS) between the two arms at 60 minutes., 60 minutes

Pain score difference at 50 minutes, The difference in pain scores (measured by NRS) between the two arms., 50 minutes|Pain score difference at 40 minutes, The difference in pain scores (measured by NRS) between the two arms., 40 minutes|Pain score difference at 30 minutes, The difference in pain scores (measured by NRS) between the two arms., 30 minutes|Pain score difference at 20 minutes, The difference in pain scores (measured by NRS) between the two arms., 20 minutes|Pain score difference at 10 minutes, The difference in pain scores (measured by NRS) between the two arms., 10 minutes|Adverse events, Hypertension (SBP > 180) from documented vital signs,hypotension (SBP <90) from documented vital signs, hypoxia (oxygen saturation < 90%), respiratory depression (RR<8 or need for mechanical intervention), nausea, vomiting, symptoms of opiate withdrawal (diarrhea, abdominal pain, diaphoresis), 10, 20, 30, 40, 50, and 60 minutes|Pain reduction, Pain reduction at each time point. Measured by NRS (time 0) minus NRS (time x), 10, 20, 30, 40, 50, and 60 minutes|Successful analgesia, Proportion of patients with NRS < 3 at 60 minutes, 60 minutes|Repeat dosing, Proportion of patients requiring reducing of analgesia at 20 minutes, 20 minutes|Summed Pain Intensity difference, Measurement combining relief magnitude and duration in a single score, 60 minutes

null

Alameda Health System

null

ALL

ADULT, OLDER_ADULT

PHASE2

122

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

IRB17-04172B

2017-09-26

2018-02-01

2018-07-01

2017-08-22

null

2017-10-19

Alameda Health System, Highland Hospital, Oakland, California, 94602, United States

null

{ "Buprenorphine": [ { "intervention_type": "DRUG", "description": "Buprenorphine", "name": "Buprenorphine", "synonyms": [ "Prefin", "Subutex", "Buprenorfina", "Buprenorphine Hydrochloride", "RX-6029-M", "Espranor", "17-cyclopropylmethyl-4,5\u03b1-epoxy-7\u03b1-((S)-1-hydroxy-1,2,2-trimethylpropyl)-6-methoxy-6,14-endo-ethanomorphinan-3-ol", "Buprenorphine", "6029-M", "21-cyclopropyl-7\u03b1-[(S)-1-hydroxy-1,2,2-trimethylpropyl]-6,14-endo-ethano-6,7,8,14-tetrahydrooripavine", "2-(N-cyclopropylmethyl-4,5\u03b1-epoxy-3-hydroxy-6-methoxy-6,14-endo-ethanomorphinan-6\u03b1-yl)-3,3-dimethyl-2-butanol", "Suboxone", "Butec", "Temg\u00e9sic", "RX6029M", "(\u2212)-buprenorphine", "Buprenex", "Buprex", "RX 6029 M", "2-[3-cyclopropylmethyl-11-hydroxy-15-methoxy-(14R)-13-oxa-3-azahexacyclo[13.2.2.12,8.01,6.06,14.07,12]icosa-7,9,11-trien-16-yl]-3,3-dimethyl-2-butanol", "Hydrochloride, Buprenorphine", "Temgesic", "Buprenophine", "Sublocade", "6029M", "Buprenorphinum", "6029 M", "Buvidal", "Sixmo", "Subutex", "Buprenorphine Sublingual and Buccal (opioid dependence)", "Subutex", "Buprenorphine Sublingual and Buccal (opioid dependence)", "Buprenorphine/naloxone", "Suboxone", "Zubsolv", "Bunavail", "Buprenorphine/naloxone", "Suboxone", "Zubsolv", "Bunavail" ], "medline_plus_id": "a618015", "generic_names": [ "Buprenorphine", "Buprenorphine Sublingual and Buccal (opioid dependence)", "Buprenorphine Sublingual and Buccal (opioid dependence)" ], "nhs_url": "https://www.nhs.uk/medicines/buprenorphine-for-pain", "mesh_id": "D009294", "drugbank_id": "DB00921", "wikipedia_url": "https://en.wikipedia.org/wiki/Buprenorphine" } ], "Morphine": [ { "intervention_type": "DRUG", "description": "Morphine Sulfate", "name": "Morphine", "synonyms": [ "Anhydrous morphine", "Morphium", "MXL", "Morphine Chloride", "SDZ 202250", "Arymo", "Morphin", "(5\u03b1,6\u03b1)-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol", "Contin, MS", "Morfina", "SDZ 202 250", "(5R,6S,9R,13S,14R)-4,5-epoxy-N-methyl-7-morphinen-3,6-diol", "(7R,7AS,12bs)-3-methyl-2,3,4,4a,7,7a-hexahydro-1H-4,12-methano[1]benzofuro[3,2-e]isoquinoline-7,9-diol", "(5\u03b1,6\u03b1)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol", "Sevredol", "Oramorph", "SDZ202-250", "Morphine Sulfate (2:1), Anhydrous", "Chloride, Morphine", "Morphine", "Roxanol-T", "Morphgesic", "Oramorph SR", "Morphine Sulfate", "Morphia", "Astramorph", "Zomorph", "(5alpha,6alpha)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol", "Infumorph", "MS Contin", "Sulfate, Morphine", "Morphine Sulfate (2:1), Pentahydrate", "Morphinum", "RMS", "MST", "Kadian", "Duramorph", "SDZ 202-250", "SDZ202250", "SDZ202 250", "(5alpha,6alpha)-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol", "(\u2212)-morphine" ], "medline_plus_id": "a606006", "generic_names": [ "Morphine" ], "nhs_url": "https://www.nhs.uk/medicines/morphine", "mesh_id": "D009294", "drugbank_id": "DB00295" } ] }

NCT00243087

Investigation of Safety, Tolerability and Maximum Tolerated Dose (MTD) of BI 2536 in Patients With Recurrent Advanced Aggressive Non-Hodgkins Lymphoma (NHL)

https://clinicaltrials.gov/study/NCT00243087

null

COMPLETED

RATIONALE: BI 2536 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of BI 2536 in treating patients with refractory or relapsed advanced non-Hodgkins lymphoma.

NO

Lymphoma

DRUG: BI 2536

Maximum tolerated dose as measured by CTCAE v3.0 at days 1-22 of each course, up to 22 days of each course|Dose-limiting toxicity as measured by CTCAE v3.0 at days 1-22 of each course, up to 22 days of each course

Objective tumor response by CT scan or MRI as measured by RECIST criteria on day 22 of each even numbered course, day 22 of every second course|Pharmacokinetics as measured in blood samples at days 1, 2, 3, and 8 during first course and on day 1 of each subsequent course, day 22 of each course

null

Boehringer Ingelheim

null

ALL

ADULT, OLDER_ADULT

PHASE1

41

INDUSTRY

INTERVENTIONAL

Allocation: |Intervention Model: |Masking: NONE|Primary Purpose: TREATMENT

CDR0000446176|BOEH-BI-1216.3|UNMC-16005

2005-07

2008-08

null

2005-10-21

null

2013-11-01

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, 20007, United States|UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, 68198-6805, United States|James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, 14642, United States|M. D. Anderson Cancer Center at University of Texas, Houston, Texas, 77030-4009, United States

null

{ "BI 2536": [ { "intervention_type": "DRUG", "description": "BI 2536", "name": "BI 2536", "synonyms": [ "", "BI 2536" ], "drugbank_id": "DB16107", "generic_names": [ "BI 2536" ] } ] }

NCT05461287

Safety, Tolerability and Pharmacokinetics Study of QLS31904 in Patients With Advanced Solid Tumors

https://clinicaltrials.gov/study/NCT05461287

null

RECRUITING

This is an open label, phase 1 clinical study to evaluate the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended phase 2 dose (RP2D) of QLS31904 q2w/q3w intravenous use in patients with advanced solid tumors. Additional objectives are to characterise pharmacokinetics and pharmacodynamics, and to evaluate efficacy signals. This study is consisted of phase Ia (Dose Escalation) and phase Ib (Dose Expansion). Phase Ib will further explore QLS31904 in selected patients populations based on data from phase Ia. The Phase Ib objectives, endpoints and design will be specified in a study protocol amendment after availability of phase Ia results.

NO

Advanced Solid Tumor

DRUG: QLS31904

DLT, Dose-limiting toxicity (DLT) is defined as any of the specified toxicities evaluated as at least possibly related with the study drug within 28 days after the first dose., Up to 28 approximately days|MTD, The maximum tolerated dose (MTD) is defined as the highest dose at which DLT occurs in <1/3 subjects. The maximum administrated dose (MAD) is defined as the highest dose of all groups if MTD can not be determined., Up to 24 approximately months|RP2D, Recommended dose for phase II trials, Up to 24 approximately months

Incidence of adverse event (AE), Incidence of adverse events (AE) assessed according to NCI-CTCAE 5.0 Incidence of adverse events (AE) assessed according to NCI-CTCAE 5.0, Up to 24 approximately months|Severity of adverse event (AE), Severity of adverse events (AE) assessed according to NCI-CTCAE 5.0, Up to 24 approximately months|Incidence of serious adverse event (SAE), Incidence of serious adverse event (SAE) assessed according to NCI-CTCAE 5.0, Up to 24 approximately months|Severity of serious adverse event (SAE), Severity of serious adverse events (AE) assessed according to NCI-CTCAE 5.0, Up to 24 approximately months|Incidence of immune related adverse event (irAE), Incidence of immune related adverse event (irAE) assessed according to NCI-CTCAE 5.0, Up to 24 approximately months|Incidence of clinically significant laboratory examination and abnormal changes in other examinations, Incidence of clinically significant laboratory examination and abnormal changes in other examinations assessed according to NCI-CTCAE 5.0, Up to 24 approximately months|peak concentration (Cmax), Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters peak concentration (Cmax);, Up to 24 approximately months|time to peak (Tmax), Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters time to peak (Tmax);, Up to 24 approximately months|trough concentration (Ctrough), Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters trough concentration (Ctrough), Up to 24 approximately months|area under the plasma drug concentration-time curve (AUC0-t ), Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters area under the plasma drug concentration-time curve (AUC0-t ), Up to 24 approximately months|area under the plasma drug concentration-time curve (AUC0-inf), Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters area under the plasma drug concentration-time curve (AUC0-inf);, Up to 24 approximately months|volume of distribution (Vss), Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters volume of distribution (Vss), Up to 24 approximately months|elimination half-life (t1/2), Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters elimination half-life (t1/2), Up to 24 approximately months|clearance rate (CL), Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters clearance rate (CL);, Up to 24 approximately months|mean retention time (MRT), Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters mean retention time (MRT), Up to 24 approximately months|ORR, The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria, including objective response rate (ORR)., Up to 24 approximately months|DOR, The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria24, including duration of response (DOR);, Up to 24 approximately months|DCR, The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria24, including disease control rate (DCR);, Up to 24 approximately months|PFS/PFS6, The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria24, including progression-free survival (PFS) and percents of progression-free survival more than six months;, Up to 24 approximately months|OS, The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria24, including overall survival (OS);, Up to 24 approximately months|ADA, incidence of anti-drug body (ADA), Up to 24 approximately months|Nab, concentration of neutralizing antibody (Nab);, Up to 24 approximately months

DLL3 expression in tumor tissue, To explore the correlation between DLL3 expression in tumor tissue and the efficacy, Up to 24 approximately months|Objective response based on iRECIST criteria in patients with measurable disease, Objective response based on immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria in patients with measurable disease, Up to 24 approximately months

Qilu Pharmaceutical Co., Ltd.

null

ALL

ADULT, OLDER_ADULT

PHASE1

290

INDUSTRY

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

QLS31904-101

2022-09-30

2024-09-25

2025-05-25

2022-07-18

null

2022-11-10

Jilin Cancer Hospital, Changchun, Jilin, 132000, China

null

{ "QLS31904": [ { "intervention_type": "DRUG" } ] }

NCT02164487

Thiamin (Vitamin B1) Levels in Eating Disorder Adolescent Patients

https://clinicaltrials.gov/study/NCT02164487

null

COMPLETED

Vitamin B1 (Thiamine) is a water soluble essential nutrient; it is synthesized by a variety of plants and microorganisms. Since animals usually cannot synthesis it, humans must be supplied with exogenous vitamin B1 in the diet. The human storage of thiamine is small- about 30mg, an intake of 1-2 mg a day is needed to maintain this pool. Deficiency might occur when the vitamin is depleted from the diet in a short period. Vitamin B1 has a role in energy metabolism and main biosynthetic pathways. Low thiamine causes illnesses in the central and peripheral nervous systems as well as affecting the heart and gastrointestinal systems. Deficiency may occur from malnutrition of different mechanisms such as alcoholism, lack in diet and recently secondary to anti-obesity surgery and few case reports described eating disorders as the reason for developing deficiency causing neuropathy, (1,2) and encephalopathy (3,4,5). One of the presentations of thiamine deficiency is peripheral neuropathy mimicking Guillain-Barre syndrome, and administering the lacking vitamin improves the symptoms. One study examined the prevalence of vitamin B1 deficiency in adult anorexia nervosa patients (6) by measurement of the activation of the enzyme erythrocyte transketolase following addition of thiamin pyrophosphate and comparing them to control of blood donors. This study found significant lower levels of vitamin B1 in the anorectic patient compared to the controls. Rational of the study: The investigators assume that these few cases described of overt neurologic impairment due to vitamin B1 deficiency because of distorted eating are just the tip of the iceberg and more eating disorders patients lack thiamine, that may have neuropsychiatric effect on the illness and identifying and treating the shortage may improve the symptoms of the disorder and maybe even the distorted thoughts that are fundamental in eating disorders.

NO

Eating Disorders

null

establishing B1 levels, one year

null

Assaf-Harofeh Medical Center

null

FEMALE

CHILD, ADULT

null

69

OTHER_GOV

OBSERVATIONAL

Observational Model: |Time Perspective: p

214/12

2013-03

2015-12

2016-01

2014-06-16

null

2020-05-27

Pediatric devision Assaf harofeh MC, Zrifin, 70300, Israel

null

{}

NCT02822287

Warming Sensation and Tolerability Study of Acetylcysteine 2% Oral Solution for Productive Cough

https://clinicaltrials.gov/study/NCT02822287

null

COMPLETED

This is a 1-treatment arm, open label design. This 1-day study includes a screening on day of attendance at clinic, followed by a washout period of 30 minutes to 8 hours (if participants are eligible for dosing the same day). The study also includes a supervised dosing with 10 mL oral solution and a 1 hour in-clinic evaluation period.

YES

Common Cold

DRUG: Acetylcystine

Onset of Warming Sensation, Onset and duration of action of warming sensation was measured by two stop watches started when the participants took the oral solution. First watch was stopped at the start of warming sensation and the second watch was stopped at the end. If onset had not occurred by 10 minutes then time to onset was censored at 10 minutes. 53 of the 57 participants had onset within 10 minutes after dosing., 10 minutes post-dose|Duration of Warming Sensation, Duration of action of warming sensation was measured by two stop watches started when the participants took the oral solution. First watch was stopped at the start of warming sensation and the second watch was stopped at the end. If onset of warming sensation occurred within 10 minutes of dosing but had not ended by the end of 10 minutes following dosing, then the duration was censored at 10 minutes minus the time to onset, 10 minutes post-dose|Warming Sensation Intensity at Pre-Dose and 60 Sec (Seconds) Post-Dose, Warming Sensation Intensity was measured on 100 mm visual analogue scale (VAS), marked as no warming sensation on the left hand side (= 0 mm) and strongest possible warming sensation at the right hand side (=100 mm) at pre-dose., Pre-dose and 60 sec post-dose

Number of Participants With Acceptability of Warming Sensation, Acceptability of strength of warming sensation was measured by a scale: 5= Much too strong; 4=Too strong (too warming); 3= Just about right (pleasant warming); 2= Too weak (not warming enough); 1= Much too weak, 10 minutes post-dose|Number of Participants With Overall Opinion of Warming Sensation, Overall opinion of warming sensation was measured by scale: 9= Like extremely; 8= Like very much; 7= Like moderately; 6= Like slightly; 5= Neither like nor dislike; 4= Dislike slightly; 3= Dislike moderately; 2= Dislike very much; 1= Dislike extremely, 10 minutes post-dose|Number of Participants With Overall Opinion of Oral Solution, Overall opinion of oral solution was measured by scale: 4 = Excellent; 3 = Good; 2 = Fair; 1 = Poor; 0 = Unacceptable., 1 hour post-dose|Local Oral Tolerability, Local oral tolerability was assessed by performing oropharyngeal examination as follows: Results of oropharyngeal examination (Normal and abnormal); If abnormal, any signs of lesion on oral mucosa or irritation of oral mucosa., Day 1 (at screening and end of study)

null

GlaxoSmithKline

null

ALL

CHILD, ADULT, OLDER_ADULT

PHASE3

58

INDUSTRY

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

205034

2016-02

2016-03

2016-07-04

2017-01-31

GSK Investigational Site, Erfurt, Thueringen, 99084, Germany

null

{ "Acetylcystine": [ { "intervention_type": "DRUG" } ] }

NCT00478387

Ovarian Cancer and Immune Response to Flu Vaccine

https://clinicaltrials.gov/study/NCT00478387

null

COMPLETED

The purpose of this study is to determine what the immune response is of ovarian cancer patients in remission, when they are given the flu vaccine. After receiving the flu vaccine, patients will have blood drawn 5 times in 12 months to study antibody response to the flu vaccine.

NO

Ovarian Cancer

BIOLOGICAL: The current seasons trivalent killed influenza vaccine

null

University of Pennsylvania

National Institutes of Health (NIH)

FEMALE

ADULT, OLDER_ADULT

null

37

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

805443|UPCC 5806 (N01-A1-50024)

2006-10

2011-06

2007-05-24

null

2016-10-05

Department of Obstetrics and Gynecology, Division of GYN Oncology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

null

{ "Influenza vaccine": [ { "intervention_type": "BIOLOGICAL", "description": "The current seasons trivalent killed influenza vaccine", "name": "Influenza vaccine", "synonyms": [ "Afluria", "Influenza vaccine", "Fluarix", "Fluzone", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Influenza%20vaccine", "generic_names": [ "Influenza Vaccine, Inactivated or Recombinant", "Influenza Vaccine, Inactivated or Recombinant", "Influenza Vaccine, Inactivated or Recombinant", "Influenza Vaccine, Inactivated or Recombinant", "Influenza Vaccine, Inactivated or Recombinant", "Influenza Vaccine, Inactivated or Recombinant" ] } ] }

NCT00796887

Randomized, Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke Recovery

https://clinicaltrials.gov/study/NCT00796887

null

COMPLETED

The purpose of this study is to determine the safety, tolerability, and to explore the possible benefit of extended-release niacin (Niaspan®) in attempting to improve the recovery of patients after ischemic stroke.

NO

Ischemic Stroke

DRUG: Extended-Release Niacin|DRUG: Extended-Release Niacin|DRUG: Placebo

Number of expected serious adverse events, Analysis of the frequency and type of serious adverse events among patients in each study arm, 24 weeks

Functional Recovery, Exploratory efficacy analysis of the differences in functional recovery between each study arm as measured using the modified Rankin Scale, NIH Stroke Scale, and Barthel Index., 24 weeks

null

Henry Ford Health System

null

ALL

ADULT, OLDER_ADULT

PHASE2

28

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

HFHS-5284

2009-04

2012-08

2008-11-24

null

2012-09-14

Henry Ford Hospital, Detroit, Michigan, 48202, United States

null

{ "Extended-Release Niacin": [ { "intervention_type": "DRUG" }, { "intervention_type": "DRUG" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT02349087

EEG in Resuscitated In-hospital Patients

https://clinicaltrials.gov/study/NCT02349087

null

TERMINATED

In Kuopio University Hospital Department of Clinical Neurophysiology there have been designed a fast EEG electrode, that is suitable for acute emergency use. This study will address the clinical use of acute EEG with this fast EEG electrode in in- hospital patients who have been resuscitated due to cardiac arest. After resuscitation patients will be treated in ICU and EEG will be recorded for 24 hours.

NO

Sudden Cardiac Arrest|Seizures

DEVICE: Acute EEG with fast applicable EEG electrode

24 hours of EEG monitoring starting from resuscitation and quantity of non-convulsive status epilepticus found, 24 hours

null

Kuopio University Hospital

null

ALL

ADULT, OLDER_ADULT

null

1

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

KUH507T010

2014-12

2018-12

2020-12-31

2015-01-28

null

2021-02-18

Kuopio University Hospital, Kuopio, Northern Savo, 70210, Finland

null

{ "Acute EEG with fast applicable EEG electrode": [ { "intervention_type": "DEVICE" } ] }

NCT04717687

Pilot Study on the Evaluation of Irreversible Electroporation Technique in Infiltrating Perihilar Cholangiocarcinoma

https://clinicaltrials.gov/study/NCT04717687

HOPE

WITHDRAWN

The aim of the study is to evaluate the feasibility of irreversible electroporation in the treatment of locally advanced cholangiocarcinoma. This technique would allow to treat the unresectable part of the tumor to make it more accessible for a secondary surgery.

NO

Cholangiocarcinoma|Interventional Imaging

PROCEDURE: Irreversible electroporation

The success rate of the technique, being the realisation of the irreversible electroporation., The study will be considered positive if the success rate is above 90% and the complication rate below or equal to 30%, At Day 0

null

Poitiers University Hospital

Sport & Collection 2019

ALL

ADULT, OLDER_ADULT

null

0

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

HOPE

2021-05-01

2022-06-01

2021-01-22

null

2022-07-13

null

{ "Irreversible electroporation": [ { "intervention_type": "PROCEDURE" } ] }

NCT00004087

Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Recurrent Colorectal Cancer or Pancreatic Cancer

https://clinicaltrials.gov/study/NCT00004087

null

COMPLETED

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by monoclonal antibody therapy used to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody plus peripheral stem cell transplantation in treating patients who have metastatic or recurrent colorectal cancer or pancreatic cancer that has not responded to previous treatment.

NO

Colorectal Cancer|Pancreatic Cancer

BIOLOGICAL: filgrastim|PROCEDURE: autologous bone marrow transplantation|PROCEDURE: peripheral blood stem cell transplantation|RADIATION: indium In 111 monoclonal antibody MN-14|RADIATION: yttrium Y 90 monoclonal antibody MN-14

maximum tolerated dose, 12 weeks

null

Garden State Cancer Center at the Center for Molecular Medicine and Immunology

National Cancer Institute (NCI)

ALL

ADULT, OLDER_ADULT

PHASE1|PHASE2

15

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

CDR0000067300|P01CA054425|CMMI-C-033-98|NCI-H99-0042|NCI-V99-1571

1997-03

2001-05

null

2004-04-16

null

2011-06-22

Garden State Cancer Center, Belleville, New Jersey, 07103, United States|St. Josephs Hospital and Medical Center, Paterson, New Jersey, 07503, United States|University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, 19104, United States

null

{ "Filgrastim": [ { "intervention_type": "BIOLOGICAL", "description": "filgrastim", "name": "Filgrastim", "synonyms": [ "Granulocyte Colony Stimulating Factor", "Nivestym", "Granulocyte Colony-Stimulating Factor", "Filgrastim-aafi", "R metHuG CSF", "G-CSF Recombinant, Human Methionyl", "Fraven", "Recombinant Methionyl Human Granulocyte Colony Stimulating Factor", "Granix", "G-CSF", "Tbo Filgrastim", "Topneuter", "Filgrastim-sndz", "Zarxio", "Tbo-filgrastim", "R-metHuG-CSF", "Recombinant Methionyl Human G-CSF", "Tbo-Filgrastim", "Recombinant-Methionyl Human Granulocyte Colony-Stimulating Factor", "Filgrastim", "G CSF Recombinant, Human Methionyl", "Neupogen" ], "medline_plus_id": "a692033", "generic_names": [ "Filgrastim" ], "mesh_id": "D006401", "drugbank_id": "DB00099", "wikipedia_url": "https://en.wikipedia.org/wiki/Filgrastim" } ], "autologous bone marrow transplantation": [ { "intervention_type": "PROCEDURE" } ], "peripheral blood stem cell transplantation": [ { "intervention_type": "PROCEDURE" } ], "indium In 111 monoclonal antibody MN-14": [ { "intervention_type": "RADIATION" } ], "yttrium Y 90 monoclonal antibody MN-14": [ { "intervention_type": "RADIATION" } ] }

NCT00171587

Study of the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Effects of Vatalanib in Combination With Capecitabine in Patients With Advanced Cancer

https://clinicaltrials.gov/study/NCT00171587

null

COMPLETED

The objective of this study is to assess the safety, tolerability, dose limiting toxicity, and maximum tolerated dose of vatalanib administered orally once daily in combination with capecitabine in patients with advanced cancer. The study is also designed to determine the effect of vatalanib on the pharmacokinetics of capecitabine and the effect of capecitabine on the pharmacokinetics of vatalanib, and to describe the anti-tumor activity of this combination regimen.

NO

Tumors|Neoplasm Metastasis

DRUG: PTK787/ZK 222584 (vatalanib)

Safety|Tolerability

Pharmacokinetics

null

Novartis

Bayer

ALL

ADULT, OLDER_ADULT

PHASE1|PHASE2

22

INDUSTRY

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

CPTK787 0134/306220

2002-05

2007-03

2005-09-15

null

2009-11-19

University of Chicago, Chicago, Illinois, 60637, United States

null

{ "PTK787/ZK 222584 (vatalanib)": [ { "intervention_type": "DRUG" } ] }

NCT00538187

Obatoclax and Bortezomib in Treating Patients With Aggressive Relapsed or Recurrent Non-Hodgkin Lymphoma

https://clinicaltrials.gov/study/NCT00538187

null

TERMINATED

Obatoclax may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. Bortezomib and obatoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving obatoclax together with bortezomib may kill more cancer cells. This phase I/II trial is studying the side effects and best dose of obatoclax when given together with bortezomib and to see how well they work in treating patients with aggressive relapsed or recurrent non-Hodgkin lymphoma.

NO

DRUG: obatoclax mesylate|DRUG: bortezomib|OTHER: laboratory biomarker analysis|OTHER: pharmacological study

Maximum tolerated dose of obatoclax mesylate when administered with bortezomib, Defined as the highest dose tested in which fewer than 33% of patients experienced DLT attributable to the study drug(s), when at least six patients were treated at that dose and are evaluable for toxicity. Graded according to the NCI CTCAE, Version 3.0., 35 days

Toxicity as assessed by NCI CTCAE version 3.0, Summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity and nadir or maximum values for the laboratory measures, time of onset (i.e. course number), duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and by course., Up to 26 weeks after completion of study treatment|Pharmacokinetics of obatoclax mesylate when administered with bortezomib, Dose 1 of course 1, pre-infusion, 1 and 2 hours into the infusion, immediately prior to the end of the infusion, then at 0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, and 168 hours

null

National Cancer Institute (NCI)

null

ALL

ADULT, OLDER_ADULT

PHASE1

18

NIH

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

NCI-2009-00253|PHI-58|CDR0000566357|U01CA062505

2007-12

2011-04

null

2007-10-02

null

2015-12-04

City of Hope Medical Center, Duarte, California, 91010, United States

null

{ "Obatoclax": [ { "intervention_type": "DRUG", "description": "obatoclax mesylate", "name": "Obatoclax", "synonyms": [ "Obatoclax" ], "drugbank_id": "DB12191", "generic_names": [ "Obatoclax" ] } ], "Bortezomib": [ { "intervention_type": "DRUG", "description": "bortezomib", "name": "Bortezomib", "synonyms": [ "[(1R)-3-methyl-1-({(2S)-3-phenyl-2-[(pyrazin-2-ylcarbonyl)amino]propanoyl}amino)butyl]boronic acid", "N-[(1R)-1-(DIHYDROXYBORYL)-3-methylbutyl]-N-(pyrazin-2-ylcarbonyl)-L-phenylalaninamide", "Bortezomib", "Velcade" ], "medline_plus_id": "a607007", "generic_names": [ "Bortezomib" ], "mesh_id": "D000970", "drugbank_id": "DB00188" } ], "laboratory biomarker analysis": [ { "intervention_type": "OTHER" } ], "pharmacological study": [ { "intervention_type": "OTHER" } ] }

NCT04339387

COVID-19 Risk Stratification

https://clinicaltrials.gov/study/NCT04339387

null

COMPLETED

The investigators seek to derive and validate a clinically useful risk score for patients with Coronavirus Disease 2019 to aide clinicians in the safe discharge of patients.

NO

Coronavirus|Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere

null

Suitable for discharge, Patient with COVID-19 who does not require supplemental oxygen, does not require intensive care unit-level care, and does not die., Duration of participation in cohort, expected to be between 1 day and 20 days.

null

Brigham and Womens Hospital

null

ALL

ADULT, OLDER_ADULT

null

1,326

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2020P000944

2020-03-01

2020-04-26

2020-04-09

null

2020-11-30

Brigham and Womens Hospital, Boston, Massachusetts, 02115, United States

null

{}

NCT02065687

Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer

https://clinicaltrials.gov/study/NCT02065687

null

UNKNOWN

This randomized phase II/III trial studies how well paclitaxel, carboplatin, and metformin hydrochloride works and compares it to paclitaxel, carboplatin, and placebo in treating patients with endometrial cancer that is stage III, IV, or has come back. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride may help paclitaxel and carboplatin work better by making cancer cells more sensitive to the drugs. It is not yet known whether paclitaxel and carboplatin is more effective with or without metformin hydrochloride in treating endometrial cancer.

YES

Progression-free Survival (PFS) (Phase II), Time until disease progression, death, or date of last contact. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined., From date of study entry to time of progression or death, whichever occurs first, assessed up to 5 years|Overall Survival (OS) (Phase II and III), The observed length of life from randomization into the study to death or the date of last contact. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined., From date of study entry to time of death or the date of last contact, assessed up to 5 years

Proportion of Patients Responding to Therapy, The proportion of patients who had a response (complete or partial) by RECIST 1.1. Measurable disease is defined by RECIST (version 1.1). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or ≥ 20 mm when measured by chest x-ray. Lymph nodes must be > 15 mm in short axis when measured by CT or MRI., During study treatment, up to 5 years.|Duration of Response by Treatment, Duration of response until disease progression, death, or date last seen among patients who responded., From the date of response to disease progression, death, or date last seen assessed up to 5 years|Overall Survival (OS) (Phase II), The observed length of life from randomization into the study to death or the date of last contact. For response, only those patients who had measurable disease were included in an analysis of response. Non-measurable patients are included in the ITT analysis. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined., From date of study entry to time of death or the date of last contact, assessed up to 5 years.|Progression Free Survival (PFS) (Phase III), Time until disease progression, death, or date of last contact. For response, only those patients who had measurable disease were included in an analysis of response. Non-measurable patients are included in the ITT analysis. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined., From date of study entry to time of progression or death, whichever occurs first, assessed up to 5 years|Number of Participants With Grade 3 or Higher Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 4, Toxicities will be assessed by organ or organ system. For each category of toxicity, each patient will be evaluated by the worst grade experienced during the course of therapy. Data will be summarized by frequency and severity according to the regimen administered. The number of patients with a grade three or greater adverse event will be reported (by system organ class)., Up to 5 years|Level of Obesity, Obesity will be quantitative assessed by body mass index (BMI) and will be assessed for its predictive and prognostic significance. The interaction between BMI and metformin treatment will be examined with an interaction term in a Cox proportional hazards model., Up to 5 years

Metabolic Factor Levels, Hip-to-waist ratio, diabetes status, hemoglobin A1c, fasting insulin glucose levels, and homeostatic model assessment scores will be assessed for their predictive and prognostic significance. Variables will be analyzed as continuous covariates (or as appropriate with transformations such as the logarithm) with Cox models or logistic regression., Up to 5 years|Incidence of PIK3 Mutations/Amplifications, PIK3CA mutations/amplifications and PIK3R1/PIK3R2 mutations will be examined for prognostic and predictive significance., Up to 5 years|Expression of MATE 2, Expression will be examined by immunohistochemistry with intensity of staining and the percentage of cells staining positive. From these statistics, an H-score will be calculated. Expression will be further dichotomized as high expression and low expression at the median to maximize the power of the study., Up to 5 years|Levels of Key Targets of the Metformin/mTOR Signaling Pathway, Levels before and after treatment will be assessed for their predictive and prognostic significance., Up to 5 years

Gynecologic Oncology Group

National Cancer Institute (NCI)

FEMALE

ADULT, OLDER_ADULT

PHASE2|PHASE3

469

NETWORK

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT

GOG-0286B|NCI-2013-02284|s14-01068|GOG-0286B|GOG-0286B|GOG-0286B|U10CA180830|U10CA180868|U10CA027469

2014-03-17

2019-04-17

2023-09-13

2014-02-19

2021-01-12

2021-09-30

University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, 35233, United States|Tennessee Valley Gynecologic Oncology, Huntsville, Alabama, 35805, United States|Cancer Center at Saint Josephs, Phoenix, Arizona, 85004, United States|Saint Josephs Hospital and Medical Center, Phoenix, Arizona, 85013, United States|Arizona Oncology Associates-Biltmore Cancer Center, Phoenix, Arizona, 85016, United States|Arizona Oncology Associates-West Orange Grove, Tucson, Arizona, 85704, United States|Arizona Oncology Associates-Wilmot, Tucson, Arizona, 85710, United States|Banner University Medical Center - Tucson, Tucson, Arizona, 85719, United States|University of Arizona Cancer Center-North Campus, Tucson, Arizona, 85719, United States|University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States|John Muir Medical Center-Concord Campus, Concord, California, 94520, United States|UC San Diego Moores Cancer Center, La Jolla, California, 92093, United States|Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, 90027, United States|Los Angeles County-USC Medical Center, Los Angeles, California, 90033, United States|USC / Norris Comprehensive Cancer Center, Los Angeles, California, 90033, United States|Cedars Sinai Medical Center, Los Angeles, California, 90048, United States|UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, 90095, United States|Palo Alto Medical Foundation-Gynecologic Oncology, Mountain View, California, 94040, United States|Kaiser Permanente-Oakland, Oakland, California, 94611, United States|Saint Joseph Hospital - Orange, Orange, California, 92868, United States|UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, 92868, United States|Palo Alto Medical Foundation Health Care, Palo Alto, California, 94301, United States|Stanford Cancer Institute Palo Alto, Palo Alto, California, 94304, United States|Keck Medical Center of USC Pasadena, Pasadena, California, 91105, United States|Kaiser Permanente-Roseville, Roseville, California, 95661, United States|University of California Davis Comprehensive Cancer Center, Sacramento, California, 95817, United States|Kaiser Permanente - Sacramento, Sacramento, California, 95825, United States|Zuckerberg San Francisco General Hospital, San Francisco, California, 94110, United States|California Pacific Medical Center-Pacific Campus, San Francisco, California, 94115, United States|Kaiser Permanente-San Francisco, San Francisco, California, 94115, United States|UCSF Medical Center-Mount Zion, San Francisco, California, 94115, United States|UCSF Medical Center-Mission Bay, San Francisco, California, 94158, United States|Kaiser Permanente-Santa Teresa-San Jose, San Jose, California, 95119, United States|Kaiser Permanente San Leandro, San Leandro, California, 94577, United States|Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, 95051, United States|Palo Alto Medical Foundation-Santa Cruz, Santa Cruz, California, 95065, United States|Kaiser Permanente-South San Francisco, South San Francisco, California, 94080, United States|Palo Alto Medical Foundation-Sunnyvale, Sunnyvale, California, 94086, United States|Olive View-University of California Los Angeles Medical Center, Sylmar, California, 91342, United States|Kaiser Permanente-Vallejo, Vallejo, California, 94589, United States|Kaiser Permanente-Walnut Creek, Walnut Creek, California, 94596, United States|John Muir Medical Center-Walnut Creek, Walnut Creek, California, 94598, United States|University of Colorado Hospital, Aurora, Colorado, 80045, United States|Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, 80907, United States|Poudre Valley Hospital, Fort Collins, Colorado, 80524, United States|Smilow Cancer Hospital-Derby Care Center, Derby, Connecticut, 06418, United States|Smilow Cancer Hospital Care Center-Fairfield, Fairfield, Connecticut, 06824, United States|Smilow Cancer Hospital Care Center - Guiford, Guilford, Connecticut, 06437, United States|Hartford Hospital, Hartford, Connecticut, 06102, United States|Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, 06105, United States|Midstate Medical Center, Meriden, Connecticut, 06451, United States|The Hospital of Central Connecticut, New Britain, Connecticut, 06050, United States|Yale University, New Haven, Connecticut, 06520, United States|Yale-New Haven Hospital North Haven Medical Center, North Haven, Connecticut, 06473, United States|Smilow Cancer Hospital-Orange Care Center, Orange, Connecticut, 06477, United States|Smilow Cancer Hospital-Torrington Care Center, Torrington, Connecticut, 06790, United States|Smilow Cancer Hospital Care Center-Trumbull, Trumbull, Connecticut, 06611, United States|Smilow Cancer Hospital-Waterbury Care Center, Waterbury, Connecticut, 06708, United States|Christiana Gynecologic Oncology LLC, Newark, Delaware, 19713, United States|Helen F Graham Cancer Center, Newark, Delaware, 19713, United States|Medical Oncology Hematology Consultants PA, Newark, Delaware, 19713, United States|Christiana Care Health System-Christiana Hospital, Newark, Delaware, 19718, United States|Beebe Health Campus, Rehoboth Beach, Delaware, 19971, United States|Christiana Care Health System-Wilmington Hospital, Wilmington, Delaware, 19801, United States|University of Florida Health Science Center - Gainesville, Gainesville, Florida, 32610, United States|AdventHealth Orlando, Orlando, Florida, 32803, United States|Womens Cancer Associates, Saint Petersburg, Florida, 33713, United States|Sarasota Memorial Hospital, Sarasota, Florida, 34239, United States|Emory University Hospital Midtown, Atlanta, Georgia, 30308, United States|Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, 30322, United States|Northside Hospital, Atlanta, Georgia, 30342, United States|Augusta University Medical Center, Augusta, Georgia, 30912, United States|Dekalb Medical Center, Decatur, Georgia, 30033, United States|Northeast Georgia Medical Center-Gainesville, Gainesville, Georgia, 30501, United States|Lewis Cancer and Research Pavilion at Saint Josephs/Candler, Savannah, Georgia, 31405, United States|Pali Momi Medical Center, Aiea, Hawaii, 96701, United States|Queens Cancer Center - Pearlridge, Aiea, Hawaii, 96701, United States|The Cancer Center of Hawaii-Pali Momi, Aiea, Hawaii, 96701, United States|Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu, Hawaii, 96813, United States|Queens Medical Center, Honolulu, Hawaii, 96813, United States|Straub Clinic and Hospital, Honolulu, Hawaii, 96813, United States|University of Hawaii Cancer Center, Honolulu, Hawaii, 96813, United States|Hawaii Cancer Care Inc-Liliha, Honolulu, Hawaii, 96817, United States|Kuakini Medical Center, Honolulu, Hawaii, 96817, United States|Queens Cancer Center - Kuakini, Honolulu, Hawaii, 96817, United States|The Cancer Center of Hawaii-Liliha, Honolulu, Hawaii, 96817, United States|Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, 96826, United States|Wilcox Memorial Hospital and Kauai Medical Clinic, Lihue, Hawaii, 96766, United States|Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, 83706, United States|Northwest Community Hospital, Arlington Heights, Illinois, 60005, United States|Rush - Copley Medical Center, Aurora, Illinois, 60504, United States|Illinois CancerCare-Bloomington, Bloomington, Illinois, 61704, United States|Illinois CancerCare-Canton, Canton, Illinois, 61520, United States|Illinois CancerCare-Carthage, Carthage, Illinois, 62321, United States|Northwestern University, Chicago, Illinois, 60611, United States|Rush University Medical Center, Chicago, Illinois, 60612, United States|University of Chicago Comprehensive Cancer Center, Chicago, Illinois, 60637, United States|Carle on Vermilion, Danville, Illinois, 61832, United States|Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, 62526, United States|Decatur Memorial Hospital, Decatur, Illinois, 62526, United States|Carle Physician Group-Effingham, Effingham, Illinois, 62401, United States|Crossroads Cancer Center, Effingham, Illinois, 62401, United States|AMITA Health Alexian Brothers Medical Center, Elk Grove Village, Illinois, 60007, United States|Illinois CancerCare-Eureka, Eureka, Illinois, 61530, United States|NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, 60201, United States|Illinois CancerCare-Galesburg, Galesburg, Illinois, 61401, United States|Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, 60134, United States|NorthShore University HealthSystem-Glenbrook Hospital, Glenview, Illinois, 60026, United States|NorthShore University HealthSystem-Highland Park Hospital, Highland Park, Illinois, 60035, United States|Sudarshan K Sharma MD Limited-Gynecologic Oncology, Hinsdale, Illinois, 60521, United States|Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, 61443, United States|Illinois CancerCare-Macomb, Macomb, Illinois, 61455, United States|Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, 61938, United States|UC Comprehensive Cancer Center at Silver Cross, New Lenox, Illinois, 60451, United States|Cancer Care Center of OFallon, OFallon, Illinois, 62269, United States|University of Chicago Medicine-Orland Park, Orland Park, Illinois, 60462, United States|Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, 61350, United States|Illinois CancerCare-Pekin, Pekin, Illinois, 61554, United States|Illinois CancerCare-Peoria, Peoria, Illinois, 61615, United States|Illinois CancerCare-Peru, Peru, Illinois, 61354, United States|Illinois CancerCare-Princeton, Princeton, Illinois, 61356, United States|North Shore Medical Center, Skokie, Illinois, 60076, United States|Central Illinois Hematology Oncology Center, Springfield, Illinois, 62702, United States|Southern Illinois University School of Medicine, Springfield, Illinois, 62702, United States|Springfield Clinic, Springfield, Illinois, 62702, United States|Memorial Medical Center, Springfield, Illinois, 62781, United States|Carle Cancer Center, Urbana, Illinois, 61801, United States|The Carle Foundation Hospital, Urbana, Illinois, 61801, United States|Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, 60555, United States|Rush-Copley Healthcare Center, Yorkville, Illinois, 60560, United States|Michiana Hematology Oncology PC-Crown Point, Crown Point, Indiana, 46307, United States|Michiana Hematology Oncology PC-Elkhart, Elkhart, Indiana, 46514, United States|Elkhart General Hospital, Elkhart, Indiana, 46515, United States|Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, 46202, United States|Saint Vincent Hospital and Health Care Center, Indianapolis, Indiana, 46260, United States|IU Health La Porte Hospital, La Porte, Indiana, 46350, United States|Franciscan Saint Anthony Health-Michigan City, Michigan City, Indiana, 46360, United States|Woodland Cancer Care Center, Michigan City, Indiana, 46360, United States|Michiana Hematology Oncology PC-Mishawaka, Mishawaka, Indiana, 46545, United States|Saint Joseph Regional Medical Center-Mishawaka, Mishawaka, Indiana, 46545, United States|Michiana Hematology Oncology PC-South Bend, South Bend, Indiana, 46601, United States|Michiana Hematology Oncology PC-Westville, Westville, Indiana, 46391, United States|Mary Greeley Medical Center, Ames, Iowa, 50010, United States|McFarland Clinic PC - Ames, Ames, Iowa, 50010, United States|McFarland Clinic PC-Boone, Boone, Iowa, 50036, United States|Medical Oncology and Hematology Associates-West Des Moines, Clive, Iowa, 50325, United States|Mercy Cancer Center-West Lakes, Clive, Iowa, 50325, United States|Medical Oncology and Hematology Associates-Laurel, Des Moines, Iowa, 50314, United States|Mercy Medical Center - Des Moines, Des Moines, Iowa, 50314, United States|McFarland Clinic PC-Trinity Cancer Center, Fort Dodge, Iowa, 50501, United States|University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, 52242, United States|McFarland Clinic PC-Jefferson, Jefferson, Iowa, 50129, United States|McFarland Clinic PC-Marshalltown, Marshalltown, Iowa, 50158, United States|Mercy Medical Center - North Iowa, Mason City, Iowa, 50401, United States|Saint Elizabeth Medical Center South, Edgewood, Kentucky, 41017, United States|Saint Elizabeth Fort Thomas, Fort Thomas, Kentucky, 41075, United States|University of Kentucky/Markey Cancer Center, Lexington, Kentucky, 40536, United States|Womans Hospital, Baton Rouge, Louisiana, 70817, United States|Ochsner Medical Center Jefferson, New Orleans, Louisiana, 70121, United States|Maine Medical Center- Scarborough Campus, Scarborough, Maine, 04074, United States|Greater Baltimore Medical Center, Baltimore, Maryland, 21204, United States|Sinai Hospital of Baltimore, Baltimore, Maryland, 21215, United States|Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, 21287, United States|Walter Reed National Military Medical Center, Bethesda, Maryland, 20889-5600, United States|Tufts Medical Center, Boston, Massachusetts, 02111, United States|Brigham and Womens Hospital, Boston, Massachusetts, 02115, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States|Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States|Lowell General Hospital, Lowell, Massachusetts, 01854, United States|Baystate Medical Center, Springfield, Massachusetts, 01199, United States|UMass Memorial Medical Center - Memorial Division, Worcester, Massachusetts, 01605, United States|Michigan Cancer Research Consortium NCORP, Ann Arbor, Michigan, 48106, United States|Saint Joseph Mercy Hospital, Ann Arbor, Michigan, 48106, United States|University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109, United States|Bronson Battle Creek, Battle Creek, Michigan, 49017, United States|Beaumont Hospital - Dearborn, Dearborn, Michigan, 48124, United States|Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, 48201, United States|Green Bay Oncology - Escanaba, Escanaba, Michigan, 49829, United States|Weisberg Cancer Treatment Center, Farmington Hills, Michigan, 48334, United States|Genesys Hurley Cancer Institute, Flint, Michigan, 48503, United States|Hurley Medical Center, Flint, Michigan, 48503, United States|Helen DeVos Childrens Hospital at Spectrum Health, Grand Rapids, Michigan, 49503, United States|Mercy Health Saint Marys, Grand Rapids, Michigan, 49503, United States|Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, 49503, United States|Green Bay Oncology - Iron Mountain, Iron Mountain, Michigan, 49801, United States|Allegiance Health, Jackson, Michigan, 49201, United States|West Michigan Cancer Center, Kalamazoo, Michigan, 49007, United States|Sparrow Hospital, Lansing, Michigan, 48912, United States|Saint Mary Mercy Hospital, Livonia, Michigan, 48154, United States|Monroe Cancer Center, Monroe, Michigan, 48162, United States|Mercy Health Mercy Campus, Muskegon, Michigan, 49444, United States|Saint Joseph Mercy Oakland, Pontiac, Michigan, 48341, United States|Lake Huron Medical Center, Port Huron, Michigan, 48060, United States|Spectrum Health Reed City Hospital, Reed City, Michigan, 49677, United States|William Beaumont Hospital-Royal Oak, Royal Oak, Michigan, 48073, United States|Ascension Saint Marys Hospital, Saginaw, Michigan, 48601, United States|Munson Medical Center, Traverse City, Michigan, 49684, United States|William Beaumont Hospital - Troy, Troy, Michigan, 48085, United States|Saint John Macomb-Oakland Hospital, Warren, Michigan, 48093, United States|Sanford Joe Lueken Cancer Center, Bemidji, Minnesota, 56601, United States|Mercy Hospital, Coon Rapids, Minnesota, 55433, United States|Fairview Southdale Hospital, Edina, Minnesota, 55435, United States|Abbott-Northwestern Hospital, Minneapolis, Minnesota, 55407, United States|University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, 55455, United States|Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States|Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, 55416, United States|Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, 55416, United States|United Hospital, Saint Paul, Minnesota, 55102, United States|Lakeview Hospital, Stillwater, Minnesota, 55082, United States|Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, 55125, United States|Saint Dominic-Jackson Memorial Hospital, Jackson, Mississippi, 39216, United States|University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States|Saint Francis Medical Center, Cape Girardeau, Missouri, 63703, United States|Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, 65401, United States|Mercy Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, 65401, United States|Barnes-Jewish Hospital, Saint Louis, Missouri, 63110, United States|Washington University School of Medicine, Saint Louis, Missouri, 63110, United States|Mercy Hospital Saint Louis, Saint Louis, Missouri, 63141, United States|Cancer Research for the Ozarks NCORP, Springfield, Missouri, 65804, United States|Mercy Hospital Springfield, Springfield, Missouri, 65804, United States|CoxHealth South Hospital, Springfield, Missouri, 65807, United States|Billings Clinic Cancer Center, Billings, Montana, 59101, United States|Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, 59405, United States|Kalispell Regional Medical Center, Kalispell, Montana, 59901, United States|CHI Health Saint Francis, Grand Island, Nebraska, 68803, United States|CHI Health Good Samaritan, Kearney, Nebraska, 68847, United States|Nebraska Methodist Hospital, Omaha, Nebraska, 68114, United States|University of Nebraska Medical Center, Omaha, Nebraska, 68198, United States|Womens Cancer Center of Nevada, Las Vegas, Nevada, 89169, United States|Center of Hope at Renown Medical Center, Reno, Nevada, 89502, United States|Renown Regional Medical Center, Reno, Nevada, 89502, United States|Wentworth-Douglass Hospital, Dover, New Hampshire, 03820, United States|Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, 03756, United States|Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, 07920, United States|Cooper Hospital University Medical Center, Camden, New Jersey, 08103, United States|Memorial Sloan Kettering Monmouth, Middletown, New Jersey, 07748, United States|Morristown Medical Center, Morristown, New Jersey, 07960, United States|Virtua Memorial, Mount Holly, New Jersey, 08060, United States|Overlook Hospital, Summit, New Jersey, 07902, United States|MD Anderson Cancer Center at Cooper-Voorhees, Voorhees, New Jersey, 08043, United States|Virtua Voorhees, Voorhees, New Jersey, 08043, United States|University of New Mexico Cancer Center, Albuquerque, New Mexico, 87102, United States|Southwest Gynecologic Oncology Associates Inc, Albuquerque, New Mexico, 87106, United States|Womens Cancer Care Associates LLC, Albany, New York, 12208, United States|Montefiore Medical Center-Einstein Campus, Bronx, New York, 10461, United States|Montefiore Medical Center-Weiler Hospital, Bronx, New York, 10461, United States|Montefiore Medical Center - Moses Campus, Bronx, New York, 10467, United States|State University of New York Downstate Medical Center, Brooklyn, New York, 11203, United States|New York-Presbyterian/Brooklyn Methodist Hospital, Brooklyn, New York, 11215, United States|Roswell Park Cancer Institute, Buffalo, New York, 14263, United States|Memorial Sloan Kettering Commack, Commack, New York, 11725, United States|Glens Falls Hospital, Glens Falls, New York, 12801, United States|Memorial Sloan Kettering Westchester, Harrison, New York, 10604, United States|NYU Winthrop Hospital, Mineola, New York, 11501, United States|Mount Sinai Union Square, New York, New York, 10003, United States|Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, 10016, United States|Mount Sinai Hospital, New York, New York, 10029, United States|NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, 10032, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|Memorial Sloan Kettering Sleepy Hollow, Sleepy Hollow, New York, 10591, United States|Stony Brook University Medical Center, Stony Brook, New York, 11794, United States|Memorial Sloan Kettering Nassau, Uniondale, New York, 11553, United States|Westchester Medical Center, Valhalla, New York, 10595, United States|Dickstein Cancer Treatment Center, White Plains, New York, 10601, United States|UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, 27599, United States|Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, 28203, United States|Novant Health Presbyterian Medical Center, Charlotte, North Carolina, 28204, United States|Southeastern Medical Oncology Center-Clinton, Clinton, North Carolina, 28328, United States|Atrium Health Cabarrus/LCI-Concord, Concord, North Carolina, 28025, United States|Duke University Medical Center, Durham, North Carolina, 27710, United States|Southeastern Medical Oncology Center-Goldsboro, Goldsboro, North Carolina, 27534, United States|Wayne Memorial Hospital, Goldsboro, North Carolina, 27534, United States|AdventHealth Hendersonville, Hendersonville, North Carolina, 28792, United States|Onslow Memorial Hospital, Jacksonville, North Carolina, 28546, United States|Southeastern Medical Oncology Center-Jacksonville, Jacksonville, North Carolina, 28546, United States|Novant Health Cancer Institute - Kernersville, Kernersville, North Carolina, 27284, United States|Novant Health Cancer Institute - Mount Airy, Mount Airy, North Carolina, 27030, United States|FirstHealth of the Carolinas-Moore Regional Hospital, Pinehurst, North Carolina, 28374, United States|Duke Raleigh Hospital, Raleigh, North Carolina, 27609, United States|Novant Health Cancer Institute - Statesville, Statesville, North Carolina, 28625, United States|Novant Health Cancer Institute - Thomasville, Thomasville, North Carolina, 27360, United States|Novant Health Cancer Institute - Wilkesboro, Wilkesboro, North Carolina, 28659, United States|New Hanover Regional Medical Center/Zimmer Cancer Center, Wilmington, North Carolina, 28401, United States|Novant Health Oncology Specialists, Winston-Salem, North Carolina, 27103, United States|Winston-Salem Health Care, Winston-Salem, North Carolina, 27103, United States|Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157, United States|Sanford Bismarck Medical Center, Bismarck, North Dakota, 58501, United States|Sanford Broadway Medical Center, Fargo, North Dakota, 58122, United States|Sanford Clinic North-Fargo, Fargo, North Dakota, 58122, United States|Sanford Roger Maris Cancer Center, Fargo, North Dakota, 58122, United States|Summa Health System - Akron Campus, Akron, Ohio, 44304, United States|University of Cincinnati Cancer Center-UC Medical Center, Cincinnati, Ohio, 45219, United States|Good Samaritan Hospital - Cincinnati, Cincinnati, Ohio, 45220, United States|Bethesda North Hospital, Cincinnati, Ohio, 45242, United States|Case Western Reserve University, Cleveland, Ohio, 44106, United States|Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, 44111, United States|Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States|Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States|Riverside Methodist Hospital, Columbus, Ohio, 43214, United States|Columbus NCI Community Oncology Research Program, Columbus, Ohio, 43215, United States|The Mark H Zangmeister Center, Columbus, Ohio, 43219, United States|Grandview Hospital, Dayton, Ohio, 45405, United States|Good Samaritan Hospital - Dayton, Dayton, Ohio, 45406, United States|Miami Valley Hospital, Dayton, Ohio, 45409, United States|Miami Valley Hospital North, Dayton, Ohio, 45415, United States|Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, 44124, United States|UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor, Ohio, 44060, United States|ProMedica Flower Hospital, Sylvania, Ohio, 43560, United States|ProMedica Toledo Hospital/Russell J Ebeid Childrens Hospital, Toledo, Ohio, 43606, United States|Wright-Patterson Medical Center, Wright-Patterson Air Force Base, Ohio, 45433, United States|University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States|Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, 74146, United States|Jefferson Abington Hospital, Abington, Pennsylvania, 19001, United States|Saint Lukes University Hospital-Bethlehem Campus, Bethlehem, Pennsylvania, 18015, United States|Geisinger Medical Center, Danville, Pennsylvania, 17822, United States|Adams Cancer Center, Gettysburg, Pennsylvania, 17325, United States|UPMC Cancer Centers - Arnold Palmer Pavilion, Greensburg, Pennsylvania, 15601, United States|Cherry Tree Cancer Center, Hanover, Pennsylvania, 17331, United States|Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania, 18201, United States|Geisinger Medical Oncology-Lewisburg, Lewisburg, Pennsylvania, 17837, United States|Lewistown Hospital, Lewistown, Pennsylvania, 17044, United States|University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, 19104, United States|Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, 19107, United States|Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111, United States|Temple University Hospital, Philadelphia, Pennsylvania, 19140, United States|UPMC-Magee Womens Hospital, Pittsburgh, Pennsylvania, 15213, United States|University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, 15232, United States|UPMC-Passavant Hospital, Pittsburgh, Pennsylvania, 15237, United States|Geisinger Cancer Services-Pottsville, Pottsville, Pennsylvania, 17901, United States|UPMC Cancer Center at UPMC Northwest, Seneca, Pennsylvania, 16346, United States|Geisinger Medical Group, State College, Pennsylvania, 16801, United States|UPMC Uniontown Hospital Radiation Oncology, Uniontown, Pennsylvania, 15401, United States|Chester County Hospital, West Chester, Pennsylvania, 19380, United States|Reading Hospital, West Reading, Pennsylvania, 19611, United States|Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, 18711, United States|WellSpan Health-York Hospital, York, Pennsylvania, 17403, United States|Women and Infants Hospital, Providence, Rhode Island, 02905, United States|AnMed Health Cancer Center, Anderson, South Carolina, 29621, United States|Medical University of South Carolina, Charleston, South Carolina, 29425, United States|Saint Francis Hospital, Greenville, South Carolina, 29601, United States|Gibbs Cancer Center-Pelham, Greer, South Carolina, 29651, United States|Carolina Blood and Cancer Care Associates PA-Lancaster, Lancaster, South Carolina, 29720, United States|Carolina Blood and Cancer Care Associates PA, Rock Hill, South Carolina, 29732, United States|Spartanburg Medical Center, Spartanburg, South Carolina, 29303, United States|Black Hills Obstetrics and Gynecology, Rapid City, South Dakota, 57701, United States|Rapid City Regional Hospital, Rapid City, South Dakota, 57701, United States|Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota, 57104, United States|Avera Cancer Institute, Sioux Falls, South Dakota, 57105, United States|Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, 57117-5134, United States|Chattanoogas Program in Womens Oncology, Chattanooga, Tennessee, 37403, United States|University of Tennessee - Knoxville, Knoxville, Tennessee, 37920, United States|Dell Seton Medical Center at The University of Texas, Austin, Texas, 78701, United States|Texas Oncology-Austin Midtown, Austin, Texas, 78705, United States|Texas Oncology - Central Austin Cancer Center, Austin, Texas, 78731, United States|Texas Oncology - South Austin Cancer Center, Austin, Texas, 78745, United States|Texas Oncology Bedford, Bedford, Texas, 76022, United States|MD Anderson in The Woodlands, Conroe, Texas, 77384, United States|Texas Health Presbyterian Hospital Dallas, Dallas, Texas, 75231, United States|Parkland Memorial Hospital, Dallas, Texas, 75235, United States|Texas Oncology at Baylor Charles A Sammons Cancer Center, Dallas, Texas, 75246, United States|UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, 75390, United States|Texas Oncology - Fort Worth Cancer Center, Fort Worth, Texas, 76104, United States|Lyndon Baines Johnson General Hospital, Houston, Texas, 77026-1967, United States|Houston Methodist Hospital, Houston, Texas, 77030, United States|M D Anderson Cancer Center, Houston, Texas, 77030, United States|Memorial Hermann Texas Medical Center, Houston, Texas, 77030, United States|Methodist Willowbrook Hospital, Houston, Texas, 77070, United States|MD Anderson West Houston, Houston, Texas, 77079, United States|MD Anderson League City, League City, Texas, 77573, United States|Texas Oncology-Longview Cancer Center, Longview, Texas, 75601, United States|MD Anderson in Sugar Land, Sugar Land, Texas, 77478, United States|Houston Methodist Sugar Land Hospital, Sugar Land, Texas, 77479, United States|Texas Oncology Cancer Center Sugar Land, Sugar Land, Texas, 77479, United States|Texas Oncology-The Woodlands, The Woodlands, Texas, 77380, United States|Tyler Cancer Center, Tyler, Texas, 75702, United States|Deke Slayton Cancer Center, Webster, Texas, 77598, United States|American Fork Hospital / Huntsman Intermountain Cancer Center, American Fork, Utah, 84003, United States|Sandra L Maxwell Cancer Center, Cedar City, Utah, 84720, United States|Logan Regional Hospital, Logan, Utah, 84321, United States|Intermountain Medical Center, Murray, Utah, 84107, United States|McKay-Dee Hospital Center, Ogden, Utah, 84403, United States|Utah Valley Regional Medical Center, Provo, Utah, 84604, United States|Dixie Medical Center Regional Cancer Center, Saint George, Utah, 84770, United States|Utah Cancer Specialists-Salt Lake City, Salt Lake City, Utah, 84106, United States|Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, 84112, United States|LDS Hospital, Salt Lake City, Utah, 84143, United States|Southwestern Vermont Medical Center, Bennington, Vermont, 05201, United States|Central Vermont Medical Center/National Life Cancer Treatment, Berlin, Vermont, 05602, United States|University of Vermont Medical Center, Burlington, Vermont, 05401, United States|University of Vermont and State Agricultural College, Burlington, Vermont, 05405, United States|Norris Cotton Cancer Center-North, Saint Johnsbury, Vermont, 05819, United States|University of Virginia Cancer Center, Charlottesville, Virginia, 22908, United States|Inova Schar Cancer Institute, Fairfax, Virginia, 22031, United States|Inova Fairfax Hospital, Falls Church, Virginia, 22042, United States|Henrico Doctors Hospital, Richmond, Virginia, 23229, United States|Virginia Gynecologic Oncology, Richmond, Virginia, 23229, United States|Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, 23298, United States|Carilion Clinic Gynecological Oncology, Roanoke, Virginia, 24016, United States|Highline Medical Center-Main Campus, Burien, Washington, 98166, United States|MultiCare Gig Harbor Medical Park, Gig Harbor, Washington, 98335, United States|Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109, United States|Seattle Cancer Care Alliance, Seattle, Washington, 98109, United States|University of Washington Medical Center - Northwest, Seattle, Washington, 98133, United States|Womens Cancer Center of Seattle, Seattle, Washington, 98133, United States|University of Washington Medical Center - Montlake, Seattle, Washington, 98195, United States|MultiCare Tacoma General Hospital, Tacoma, Washington, 98405, United States|Edwards Comprehensive Cancer Center, Huntington, West Virginia, 25701, United States|Monongalia Hospital, Morgantown, West Virginia, 26505, United States|Marshfield Clinic-Chippewa Center, Chippewa Falls, Wisconsin, 54729, United States|Marshfield Clinic Cancer Center at Sacred Heart, Eau Claire, Wisconsin, 54701, United States|Green Bay Oncology at Saint Vincent Hospital, Green Bay, Wisconsin, 54301-3526, United States|Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, 54301, United States|Green Bay Oncology Limited at Saint Marys Hospital, Green Bay, Wisconsin, 54303, United States|Saint Vincent Hospital Cancer Center at Saint Marys, Green Bay, Wisconsin, 54303, United States|University of Wisconsin Hospital and Clinics, Madison, Wisconsin, 53792, United States|Holy Family Memorial Hospital, Manitowoc, Wisconsin, 54221, United States|Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, 54449, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States|ProHealth D N Greenwald Center, Mukwonago, Wisconsin, 53149, United States|ProHealth Oconomowoc Memorial Hospital, Oconomowoc, Wisconsin, 53066, United States|Saint Vincent Hospital Cancer Center at Oconto Falls, Oconto Falls, Wisconsin, 54154, United States|Marshfield Medical Center-Rice Lake, Rice Lake, Wisconsin, 54868, United States|Marshfield Clinic Stevens Point Center, Stevens Point, Wisconsin, 54482, United States|Saint Vincent Hospital Cancer Center at Sturgeon Bay, Sturgeon Bay, Wisconsin, 54235-1495, United States|Green Bay Oncology - Sturgeon Bay, Sturgeon Bay, Wisconsin, 54235, United States|ProHealth Waukesha Memorial Hospital, Waukesha, Wisconsin, 53188, United States|UW Cancer Center at ProHealth Care, Waukesha, Wisconsin, 53188, United States|Aspirus Regional Cancer Center, Wausau, Wisconsin, 54401, United States|Marshfield Clinic-Wausau Center, Wausau, Wisconsin, 54401, United States|Marshfield Medical Center - Weston, Weston, Wisconsin, 54476, United States|Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin, 54494, United States

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT02065687/Prot_SAP_000.pdf

{ "Carboplatin": [ { "intervention_type": "DRUG", "description": "Carboplatin", "name": "Carboplatin", "synonyms": [ "Carboplatino", "Carboplatin", "cis-diammine(1,1-cyclobutanedicarboxylato)platinum", "cis-diammine(1,1-cyclobutanedicarboxylato)platinum(II)", "Paraplatin", "Carboplatine", "cis-(1,1-cyclobutanedicarboxylato)diammineplatinum(II)", "CBDCA" ], "medline_plus_id": "a695017", "generic_names": [ "Carboplatin" ], "drugbank_id": "DB00958" } ], "Laboratory Biomarker Analysis": [ { "intervention_type": "OTHER" } ], "Metformin": [ { "intervention_type": "DRUG", "description": "Metformin Hydrochloride", "name": "Metformin", "synonyms": [ "Dimethylbiguanidine", "Dimethylguanylguanidine", "Fortamet", "Metabet", "Metformin HCl", "Hydrochloride, Metformin", "Metformin", "Metformin Hydrochloride", "Diagemet", "Metformina", "Glumetza", "Trijardy", "Metforminum", "Glucient", "Glucophage", "Axpinet", "Dimethylbiguanid", "Metformine", "1,1-Dimethylbiguanide", "HCl, Metformin" ], "medline_plus_id": "a696005", "generic_names": [ "Metformin" ], "nhs_url": "https://www.nhs.uk/medicines/metformin", "mesh_id": "D007004", "drugbank_id": "DB00331", "wikipedia_url": "https://en.wikipedia.org/wiki/Metformin" } ], "Paclitaxel": [ { "intervention_type": "DRUG", "description": "Paclitaxel", "name": "Paclitaxel", "synonyms": [ "liposomal encapsulated paclitaxel", "7-epi-Taxol", "BENZENEPROPANOIC ACID, .BETA.-(BENZOYLAMINO)-.ALPHA.-HYDROXY-, (2AR,4S,4AS,6R,9S,11S,12S,12AR,12BS)-6,12B-BIS(ACETYLOXY)-12-(BENZOYLOXY)-2A,3,4,4A,5,6,9,10,11,12,12A,12B-DODECAHYDRO-4,11-DIHYDROXY-4A,8,13,13-TETRAMETHYL-5-OXO-7,11-METHANO-1H-CYCLODECA(3,", "NSC-125973", "Anzatax", "Bris Taxol", "Paxene", "Taxol A", "NAB-PACLITAXEL COMPONENT PACLITAXEL", "7 epi Taxol", "NSC125973", "Paclitaxel", "Onxol", "Praxel", "Paclitaxel, (4 alpha)-Isomer", "Taxol", "NSC 125973", "paclitaxel protein-bound particles", "Taxol, Bris", "ABI-007 COMPONENT PACLITAXEL", "5beta,20-Epoxy-1,2-alpha,4,7beta,10beta,13alpha-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine", "Nanoparticulate paclitaxel", "Paclitaxel protein-bound particles for injection suspension", "Taxol", "Paclitaxel (with polyoxyethylated castor oil)", "Taxol", "Paclitaxel (with polyoxyethylated castor oil)" ], "mesh_id": "D050257", "generic_names": [ "Paclitaxel", "Paclitaxel (with polyoxyethylated castor oil)", "Paclitaxel (with polyoxyethylated castor oil)" ], "drugbank_id": "DB01229" } ], "Placebo Administration": [ { "intervention_type": "OTHER" } ], "Quality-of-Life Assessment": [ { "intervention_type": "OTHER" } ], "Questionnaire Administration": [ { "intervention_type": "OTHER" } ] }

NCT06293287

Enoxaparin for Preventing the Radical Artery Occlusion After the Transradial Access Hepatic Arterial Infusion Chemotherapy

https://clinicaltrials.gov/study/NCT06293287

null

RECRUITING

The present investigation is designed as a single-blind, randomized, controlled, bicentric trial. The objective is to ascertain whether the subcutaneous administration of enoxaparin sodium for prophylactic anticoagulation during transradial hepatic arterial infusion chemotherapy (HAIC) can diminish the incidence of radial artery occlusion (RAO) post-procedure

NO

Radial Artery Occlusion

DRUG: Subcutaneous enoxaparin sodium|DRUG: Placebo

RAO rate after 24 hours and 21days, Radial artery Doppler ultrasounds will be performed 24 hours later and again after 21 days to assess for the occurrence of RAO., Data will be analyzed immediately after the last participant completes the 21-day post-treatment radial artery Doppler ultrasound assessment.

null

Zhongshan Hospital (Xiamen), Fudan University

null

ALL

ADULT, OLDER_ADULT

PHASE2

156

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION

DJ-2023-02

2024-01-31

2024-11-30

2025-01-30

2024-03-05

null

2024-03-08

Zhongshan Hospital, Fudan University (Xiamen Branch), Xiamen, Fujian, 361015, China

null

{ "Enoxaparin sodium": [ { "intervention_type": "DRUG", "description": "Subcutaneous enoxaparin sodium", "name": "Enoxaparin sodium", "synonyms": [ "Clexane", "Enoxaparin sodium", "Xaparin", "Lovenox" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Enoxaparin%20sodium", "generic_names": [] } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT06057987

Coronary Artery Ectasia Database - Poland

https://clinicaltrials.gov/study/NCT06057987

CARED-POL

RECRUITING

The goal of this observational study is to comprehensively investigate the current prevalence, morphological characteristics, risk factors for the development, complications as well as long-term prognosis of coronary artery aneurysm and ectasia (CAAE) in the Polish population. Data obtained from the CARED-POL Registry will enable the selection of morphological risk factors for the unfavorable course of CAAE, including the progression and development of giant aneurysms, aneurysm clotting with vessel occlusion, and thromboembolic complications. Comparing the safety and effectiveness of available CAAE treatment methods in individual patient subgroups will allow individualization of treatment, including anticoagulant therapy.

NO

Coronary Artery Aneurysm|Coronary Artery Ectasia

null

Incidence of CAAE, Incidence of CAAE in the Polish population based on coronary angiography, 12 months|All-cause death, 6 months|Re-hospitalization, Re-hospitalization for unstable angina, myocardial infarction, heart failure, bleeding, stroke, embolic events, 6 months

null

Poznan University of Medical Sciences

null

ALL

ADULT, OLDER_ADULT

null

2,000

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

687/23

2023-07-14

2024-07-14

2024-08

2023-09-28

null

2023-09-29

Poznan University of Medical Sciences, Poland, Poznań, Wielkopolska, 61-701, Poland

null

{}

NCT03261687

The Effects of a Water Based Exercise Programme and a Land Based Exercise Programme on Women Experiencing Pregnancy Related Pelvic Girdle Pain

https://clinicaltrials.gov/study/NCT03261687

null

COMPLETED

This study aimed to address whether a water exercise programme improves pain and quality of life in pregnant patients with Pelvic Girdle Pain (PGP) compared to a land-based exercise programme and the feasibility of undertaking a large-scale research programme.

NO

Pregnancy Related|Pelvic Girdle Pain

OTHER: water based exercise|OTHER: land based exercise|BEHAVIORAL: advice

Pelvic Girdle Pain Questionnaire (PGPQ), A score change of 7 was set as a clinically significant difference, 4 weeks (pre and post intervention)

Visual Analogue Scale (VAS), score change of 1.5 was set as clinically significant, 4 weeks (pre and post intervention)|Patient Specific Functional Score (PSFS), score change of 1 was set as clinically significant, 4 weeks (pre and post intervention)|Active Straight Leg Raise (ASLR)., score change of 1 was set as clinically significant, 4 weeks (pre and post intervention)

null

University of Bradford

St Georges University Hospitals NHS Foundation Trust

FEMALE

ADULT

null

23

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

IRAS 198588

2016-05-27

2016-12-31

2017-01-31

2017-08-25

null

2017-08-25

St Georges Hospital,, London, SW17 0QT, United Kingdom

null

{ "water based exercise": [ { "intervention_type": "OTHER" } ], "land based exercise": [ { "intervention_type": "OTHER" } ], "advice": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT04122287

Helicobacter Pylori First-line Treatment in Patients Allergic to Penicillin

https://clinicaltrials.gov/study/NCT04122287

null

UNKNOWN

The purpose of this study is to assess and compare the effectiveness of levofloxacin-tetracycline -containing and tinidazole-tetracycline-containing quadruple regimens for the primary treatment of Helicobacter pylori infection in patients allergic to penicillin.

NO

Helicobacter Pylori Infection

DRUG: Levofloxacin|DRUG: tinidazole

Eradication rates in 2 groups, Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up., 24 months

The rate of improving dyspepsia symptoms after Helicobacter pylori eradication, Dyspepsia symptoms will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) before and after the Helicobacter pylori eradication., 24 months|The rate of adverse events happening, Similarly, adverse events will also be measured by the Likert scale., 24 months|The rate of good compliance, Patients taken over 90% of drugs are considered to have a good compliance., 24 months

null

Shandong University

null

ALL

ADULT, OLDER_ADULT

PHASE4

250

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

2019-SDU-QILU-G709

2019-11-01

2022-10

2022-12

2019-10-10

null

2021-11-18

Qilu hospital, Jinan, Shandong, 250000, China

null

{ "Levofloxacin": [ { "intervention_type": "DRUG", "description": "Levofloxacin", "name": "Levofloxacin", "synonyms": [ "(3S)-(-)-9-fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid", "Ofloxacin, (S)-Isomer", "Tavanic", "Ofloxacin S-(-)-form", "L-Ofloxacin", "Iquix", "Levofloxacine", "Levobact", "(-)-Ofloxacin", "Levofloxacin Anhydrous", "Leflox", "Quixin", "(S)-Ofloxacin", "(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid", "Levofloxacino", "Levofloxacin", "Levofloxacin anhydrous", "Levaquin", "(S)-(-)-9-fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzooxazine-6-carboxylic acid", "Levofloxacinum", "Anhydrous, Levofloxacin" ], "medline_plus_id": "a601154", "generic_names": [ "Levofloxacin" ], "mesh_id": "D065609", "drugbank_id": "DB01137", "wikipedia_url": "https://en.wikipedia.org/wiki/Levofloxacin" } ], "Tinidazole": [ { "intervention_type": "DRUG", "description": "tinidazole", "name": "Tinidazole", "synonyms": [ "Tinidazol", "Fasigyn", "1-(2-(Ethylsulfonyl)ethyl)-2-methyl-5-nitroimidazole", "Tinidazolum", "Tinidazole", "Timidazole", "Tindamax" ], "medline_plus_id": "a604036", "generic_names": [ "Tinidazole" ], "mesh_id": "D000994", "drugbank_id": "DB00911" } ] }

NCT02098187

Pharmacokinetics of MP-3180 and Use of Noninvasive Fluorescence Detection Device in Healthy Volunteers

https://clinicaltrials.gov/study/NCT02098187

ORFM-1B

COMPLETED

The purpose of this early feasibility study was to investigate the pharmacokinetics of MP-3180 administered in rising doses and to evaluate the use of the Optical Renal Function Monitor (ORFM), an investigational noninvasive fluorescence detection device.

NO

Glomerular Filtration Rate|Acute Kidney Injury

Total plasma clearance of MP-3180 and iohexol, Blood samples were collected and analyzed using validated analytical methods. Total plasma clearance (the volume of plasma cleared of the drug over time) was calculated as: Clp = Dose/ AUC∞., Pre-dose and 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose|Renal clearance of MP-3180 and iohexol, Urine samples were collected pre-dose (time 0) and 5 mL urine samples were collected each time the subject voided. The total volume of urine excreted was recorded until 12 hours post-dose, and analyzed using validated analytical methods. Renal clearance (the volume of plasma cleared of the drug by the kidneys over time) was calculated as: CLr = Ae/ AUClast, where Ae is the cumulative amount of analyte excreted in urine over the sampling interval., 60, 120, 240, 360, 600 and 720 minutes post-dose|Maximum Plasma Concentration (Cmax) for MP-3180 and iohexol, Blood samples were collected and analyzed using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data., Pre-dose and 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose|Time to Maximum Plasma Concentration (Tmax) for MP-3180 and iohexol, Blood samples were collected and analyzed using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) was directly determined from the concentration-time data., Pre-dose and 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose|The terminal rate constant for MP-3180 and iohexol, Blood samples were collected and analyzed using validated analytical methods. The terminal rate constant (λz) was determined by linear regression of the terminal linear phase of the log plasma concentration-time profile., Pre-dose and 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose|Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration for MP-3180 and iohexol, Blood samples were collected and analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng*hr/mL) was estimated from time 0 to the last measurable concentration using noncompartmental analyses., Pre-dose and 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose|Area under the plasma concentration-time curve from time zero to infinity for MP-3180 and iohexol, Blood samples were collected and analyzed using validated analytical methods. The area under the plasma concentration-time curve (ng*hr/mL) from time 0 to infinity was calculated as: AUC∞ = AUClast + LQC/λz where LQC is the predicted concentration (based on the terminal regression) at the time of the last measurable concentration., Pre-dose and 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose|The elimination half-life of MP-3180 and iohexol, Blood samples were collected and analyzed using validated analytical methods. The elimination half-life (the time required for the concentration of the drug to reach half of its original value) was calculated as t1/2 λz= ln(2)/ λz., Pre-dose and 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose

Incidence of adverse events, An adverse event (AE) was defined as any untoward medical occurrence in a study subject after study drug administration and that did not necessarily have a causal relationship with this treatment., 1, 3, and 8 hours after dosing, and within 2 weeks after the final study dose|Number of laboratory values that fall outside of pre-specified normal ranges, Blood samples were collected and analyzed for hematology and clinical chemistry. Out of range values were documented., Pre-dose and within 2 weeks after the final study dose

Correlation between MP-3180 fluorescence intensity and MP-3180 concentration in plasma, Blood samples were collected and analyzed using validated analytical methods. The fluorescence intensity at the time of the blood sampling was compared to plasma concentrations., Pre-dose and 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose

MediBeacon

null

ALL

ADULT, OLDER_ADULT

PHASE1

16

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE

ORFM-1B

2014-03

2014-03-27

null

2016-09-26

University of Maryland, Baltimore, Maryland, 21201, United States

null

{ "Below target dose MP-3180": [ { "intervention_type": "DRUG" } ], "At target dose MP-3180": [ { "intervention_type": "DRUG" } ], "2 times above target dose MP-3180": [ { "intervention_type": "DRUG" } ], "4 times above target dose MP-3180": [ { "intervention_type": "DRUG" } ], "ORFM prototype": [ { "intervention_type": "DEVICE" } ], "Iohexol": [ { "intervention_type": "OTHER", "description": "Iohexol comparator", "name": "Iohexol", "synonyms": [ "N,N'-Bis(2,3-dihydroxypropyl)-5-(N-(2,3-dihydroxypropyl)acetamido)-2,4,6-triiodoisophthalamide", "Nycodenz", "Iohexol", "Omnipaque", "Iohexolum", "Exypaque", "Compound 545", "Iohexol 350" ], "mesh_id": "D003287", "generic_names": [ "Iohexol" ], "drugbank_id": "DB01362" } ] }

NCT04475887

Treatment of Anemia With Intravenous Iron in Patients Listed for Orthotopic Liver Transplantation

https://clinicaltrials.gov/study/NCT04475887

TRAILER

UNKNOWN

The aim of this study is to investigate whether therapy with intravenous iron carboxymaltose in patients with iron deficiency anemia (IDA) listed for orthotopic liver transplantation (OLT) increases hemoglobin concentrations and reduces intraoperative transfusion of packed red blood cells (PRBCs). The investigators hypothesize that therapy with intravenous iron will increase hemoglobin concentrations and reduce intraoperative transfusion of PRBCs in patients with IDA listed for OLT.

NO

Liver Transplantation|Blood Loss

DRUG: Iron Carboxymaltose|DRUG: Placebo

Hemoglobin at OLT, Change in hemoglobin concentrations from baseline until before induction of anesthesia for OLT, 6 months

Transfusion requirement, Transfusion of PRBCs during and within the first 24 hours following OLT, 6 months|Hemoglobin after 4 weeks, Change in hemoglobin concentrations from baseline until 4 weeks after initiation of therapy, 4 weeks

null

Medical University of Vienna

null

ALL

ADULT, OLDER_ADULT

PHASE4

60

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

1175/2017

2020-07-23

2022-12-31

2023-05-31

2020-07-17

null

2020-07-28

Medical University of Vienna, Department of Surgery, Vienna, 1090, Austria

null

{ "Iron Carboxymaltose": [ { "intervention_type": "DRUG" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }