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NCT03971487

Ocrelizumab for Psychosis by Autoimmunity

https://clinicaltrials.gov/study/NCT03971487

OPA

RECRUITING

Some people who have what doctors currently call schizophrenia or bipolar disease may actually have a brain disease caused by auto-antibodies. Auto-antibodies are produced when the normal defense mechanism of the body goes wrong and begins to attack the body, similar to friendly fire. Auto-antibodies attack brain receptors and then the person who has this problem begins to have hallucinations and other manifestations of schizophrenia, like feeling that people can see what they are thinking and also feeling that other people do not like them. If this disease is caused by auto-antibodies, typically the person is well until they are 15 years of age or older, but seldom older than 35 years. Then, in a matter of a few months they begin to have hallucinations and the other symptoms. Doctors still do not know whether some people with schizophrenia or bipolar disease have auto-antibodies attacking their brain. For this reason, in this study some of these patients will receive a treatment that suppresses the auto-antibodies and their symptoms after treatment will be compared with the symptoms of a group of similar patients who are given a preparation that looks like the real treatment, but it is not.

NO

Schizo-Affective Type of Psychosis|Schizophrenia

BEHAVIORAL: Psychosis and cognitive assessments|BEHAVIORAL: Physical and neuro-cognitive evaluations|DIAGNOSTIC_TEST: Safety labs and electrocardiogram|BIOLOGICAL: Ocrelizumab infusion

Score on the Positive and Negative Syndrome Scale (PANSS), It measures symptoms of psychosis, Six months

Score on quality of life scales for psychiatric patients, (modified to include input by caregivers), Six months|Score on NIH Cognitive Toolbox, Tablet-implemented tool testing cognitive abilities, including working memory, Six months|Antipsychotic-equivalent medication ordered by patients psychiatrist, Dose of medications for psychosis transformed to a standard equivalent, Six months

The Methodist Hospital Research Institute

Genentech, Inc.

ALL

ADULT

PHASE1|PHASE2

OTHER

INTERVENTIONAL

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

Pro00021901

2019-10-01

2025-06-30

2025-10-30

2019-06-03

2024-02-07

Houston Methodist Research Institute, Houston, Texas, 77030, United States

{ "Psychosis and cognitive assessments": [ { "intervention_type": "BEHAVIORAL" } ], "Physical and neuro-cognitive evaluations": [ { "intervention_type": "BEHAVIORAL" } ], "Safety labs and electrocardiogram": [ { "intervention_type": "DIAGNOSTIC_TEST" } ], "Ocrelizumab": [ { "intervention_type": "BIOLOGICAL", "description": "Ocrelizumab infusion", "name": "Ocrelizumab", "synonyms": [ "Ocrelizumab", "rhuMAb 2H7", "Ocrevus", "Ocrelizumab (genetical recombination)" ], "medline_plus_id": "a617026", "generic_names": [ "Ocrelizumab" ], "drugbank_id": "DB11988", "wikipedia_url": "https://en.wikipedia.org/wiki/Ocrelizumab" } ] }

NCT05756387

Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach

https://clinicaltrials.gov/study/NCT05756387

NOCTIVENT

NOT_YET_RECRUITING

The aim of the data collection is to create an advanced reliable method to remotely monitor patient on chronic home non-invasive ventilation (NIV), both regarding ventilatory efficacy and patient comfort, both in the hospital and at home by assessing gas exchange, lung mechanics and the interaction between the patient and the ventilator. For this purpose, we will set-up of databank of synchronously acquired datasets of already standard care monitored parameters during NIV (transcutaneous monitoring of gas exchange; ventilator data including data on PVA), and newly non-invasively acquired data on patient effort (EMG, patient ratings) and lung (hyper)inflation (EIT), during the set-up and follow-up of standard care chronic NIV.

NO

Chronic Respiratory Failure|Non-invasive Ventilation

DEVICE: Non-invasive ventilation

Gas exchange, Transcutaneous monitoring of gas exchange, baseline|Gas exchange, Transcutaneous monitoring of gas exchange, 2 months|Gas exchange, Transcutaneous monitoring of gas exchange, 4 months|Gas exchange, Transcutaneous monitoring of gas exchange, 6 months|Patient comfort, Patient comfort assessed by VAS scale, baseline|Patient comfort, Patient comfort assessed by VAS scale, 2 months|Patient comfort, Patient comfort assessed by VAS scale, 4 months|Patient comfort, Patient comfort assessed by VAS scale, 6 months|AECOPD, Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics), 2 months, 4 months, 6 months|AECOPD, Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics), 2 months|AECOPD, Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics), 4 months|Hospitalisations for AECOPD, Hospitalisations for acute exacerbations of COPD, 6 months|Sleep quality, Sleep quality assessing sleep depth and sleep stages, 2 months|Sleep quality, Sleep quality assessing sleep depth and sleep stages, 4 months|Sleep quality, Sleep quality assessing sleep depth and sleep stages, 6 months

University Medical Center Groningen

University of Twente|Löwenstein BV|Vivisol|Sencure BV

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

16013

2024-09-01

2028-01-01

2028-09-01

2023-03-06

2024-05-13

{ "Non-invasive ventilation": [ { "intervention_type": "DEVICE" } ] }

NCT02637687

A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children

https://clinicaltrials.gov/study/NCT02637687

SCOUT

ACTIVE_NOT_RECRUITING

The study is being done to test the safety of a cancer drug called larotrectinib in children. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. The first study part (Phase 1) is done to determine what dose level of larotrectinib is safe for children, how the drug is absorbed and changed by their bodies and how well the cancer responds to the drug. The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with larotrectininb.

NO

Solid Tumors Harboring NTRK Fusion

DRUG: Larotrectinib (Vitrakvi, BAY2757556)

Phase 1: Number of participants in an assigned dose cohort with treatment emergent adverse events (TEAEs) by grade assessed by NCI-CTCAE v 4.03 who experience a DLT, DLT: Dose-limiting toxicity. NCI-CTCAE: National Cancer Institute-Common Terminology Criteria for Adverse Events., From Day 1 to Day 28 of Cycle 1 (1 Cycle=28 days)|Phase 1: Number of participants with TEAEs, From first dose of larotrectinib up to 93 months|Phase 1: Severity of TEAEs, From first dose of larotrectinib up to 93 months|Phase 2: Overall response rate (ORR) by IRRC, Proportion of participants with a best overall response of complete response (CR) or partial response (PR) as determined by an independent radiology review committee (IRRC) based on Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, Response Assessment in Neuro Oncology (RANO) or International Neuroblastoma Response Criteria (INRC) as appropriate to tumor type who express NTRK gene fusions., From first dose of Larotrectinib to disease progression or subsequent therapy or surgical intervention or death, up to 76 months

Phase 1: Maximum concentration of larotrectinib in plasma (Cmax), Cohort 1 and 2: Cycle 1 Day 1 (C1D1) at 1 and 4 hours post-dose and C2D1 at pre-dose, and at 1 and 4 hours post-dose; Cohort 3 and Dose Expansion Cohort: C1D1 at 1 and 4 hours post-dose and C4D1 at pre-dose, 1 and 4 hours post-dose|Phase 1: Area under the concentration versus time curve from time 0 to t (AUC0-t) of larotrectinib in plasma, Cohort 1 and 2: C1D1 at 1 and 4 hours post-dose and C2D1 at pre-dose, and at 1 and 4 hours post-dose; Cohort 3 and Dose Expansion Cohort: C1D1 at 1 and 4 hours post-dose and C4D1 at pre-dose, 1 and 4 hours post-dose|Phase 1: Oral clearance (CL/F), Cohort 1 and 2: C1D1 at 1 and 4 hours post-dose and C2D1 at pre-dose, and at 1 and 4 hours post-dose; Cohort 3 and Dose Expansion Cohort: C1D1 at 1 and 4 hours post-dose and C4D1 at pre-dose, 1 and 4 hours post-dos|Phase 1: Cerebral spinal fluid/plasma ratio of larotrectinib, C1D1 in conjunction with the post-dose 1-hour PK sample|Phase 1: Maximum tolerated dose (MTD), From C1D1 to C1D28 of treatment of each participant in each of the assigned dose cohort, up to 16 months|Phase 1: Recommended dose for Phase 2, From the date a participants from assigned Cohort was administered the first dose to the date of the last dose for the last patient from the dose escalation phase, up to 16 months|Phase 1: Overall Response Rate (ORR), Proportion of participants with best overall response (BOR) of CR and PR; PFS, CBR and maximum change in tumor burden as assessed based on RECIST 1.1, INRC or RANO as appropriate for tumor type by IRRC., From first dose of Larotrectinib to disease progression or subsequent therapy or surgical intervention or death (due to any cause), up to 93 months|Phase 1: Mean change from baseline in Pain scores as assessed by the Wong-Baker Faces scale, Wong-Baker Faces Scale giving a pain scale between 0 (no hurt) to 10 (hurts worst)., Baseline and D1 of every cycle (1 Cycle=28 days), up to 93 months|Phase 1: Mean change in Health-related quality of life scores by PedsQL-Core, The health-related quality of life (HRQoL) is assessed with the Pediatrics Quality of Life - Core Module (PedsQL-Core) questionnaire that consists of various age-related items regarding physical, emotional, social and school functioning and gives an overall score between 0 (highest HRQoL) and 144 (lowest HRQoL)., Baseline and D1 of every cycle (1 Cycle=28 days), Up to 93 months|Phase 2: Best overall response (BOR), Participants with best overall response (BOR) of either CR or PR determined by Investigators or IRCs response assessment based on RANO, INRC and RECIST 1.1 as appropriate for tumor type, From first dose of Larotrectinib to disease progression or subsequent therapy or surgical intervention or death (due to any cause), up to 76 months|Phase 2: Duration of response (DOR), DOR determined by 1) an independent radiology review committee and 2) the treating Investigator., From start of first objective response of confirmed CR or PR to progression or death (due to any cause), up to 76 months|Phase 2: Proportion of patients with any tumor regression (i.e., any decrease from baseline of the longest diameters of target lesions) as a best response, From first dose of Larotrectinib, up to 76 months|Phase 2: Progression-free survival (PFS), From first dose of Larotrectinib to disease progression or subsequent therapy or surgical intervention or death (due to any cause), up to 112 months|Phase 2: Overall survival (OS), From first dose of Larotrectinib to death (due to any cause), up to 112 months|Phase 2: Number of participants with Treatment emergent adverse events (TEAEs), From first dose of larotrectinib to discontinuation of treatment or death (due to any cayse), up to 112 months|Phase 2: Severity of adverse events as assessed by NCI-CTCAE grading V 4.03, From first dose of larotrectinib to discontinuation of treatment or death (due to any cause), up to 112 months|Phase 2: Clinical Benefit Rate (CBR), CBR (i.e., best overall response of CR, PR or SD lasting 16 weeks or more as determined by 1) an independent radiology review committee (IRC) and 2) by the treating Investigator., From first dose of Larotrectinib to disease progression or subsequent therapy or surgical intervention or death (due to any cause), up to 76 months|Phase 2: Concordance coefficient, Concordance coefficient of intra-patient molecular profile, From baseline/screening and if feasible end of treatment (EOT) and or PD and or at re-start of study treatment following a drug holiday and disease recurrence, up to 112 months|Phase 2: Post-operative tumor staging, Post-operative stage in patients treated with larotrectinib according to the TNM Classification of malignant tumors of the Union for International Cancer Control (UICC)., From first dose of Larotrectinib to surgical intervention, up to 112 months|Phase 2: Post-operative surgical margin assessment, Surgical margin status in patients treated with larotrectinib using the International Cancer Control (UICC)-R classification and the Intergroup Rhabdomyosarcoma Staging (IRS) systems., From first dose of Larotrectinib to surgical intervention, up to 112 months|Phase 2: Pre-treatment surgical plan to preserve function and cosmetic outcome, Descriptive analysis of pretreatment surgical plan., From first dose of Larotrectinib to surgical intervention, up to 112 months|Phase 2: Post-treatment plans to conserve function and cosmetic outcome, Descriptive analysis of post-treatment plans, From surgical intervention to subsequent therapy, up to 112 months

Bayer

ALL

CHILD, ADULT

PHASE1|PHASE2

INDUSTRY

INTERVENTIONAL

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

20290|LOXO-TRK-15003|2022-502668-20-00|2016-003498-16

2015-12-16

2024-07-25

2026-09-22

2015-12-22

2024-05-08

Childrens Hospital of Los Angeles, Los Angeles, California, 90027, United States|UCLA Jonsson Comprehensive Cancer Center, Los Angeles, California, 90095, United States|Lucille Salter Packard Childrens Hospital at Stanford, Palo Alto, California, 94304, United States|Nemours Childrens Hospital (Orlando), Orlando, Florida, 32827, United States|Boston Childrens Hospital, Boston, Massachusetts, 02115, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|Cincinnati Childrens Hospital and Medical Center, Cincinnati, Ohio, 45229-3039, United States|Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States|St. Jude Childrens Research Hospital, Memphis, Tennessee, 38105, United States|University of Texas Southwestern Medical Center, Dallas, Texas, 75235, United States|Seattle Childrens Hospital, Seattle, Washington, 98105, United States|Sydney Childrens Hospital, Sydney, New South Wales, 2031, Australia|Womens and Childrens Hospital, North Adelaide, South Australia, 5006, Australia|Royal Childrens Hospital Melbourne, Parkville, Victoria, 3052, Australia|British Columbia Childrens Hospital, Vancouver, British Columbia, V6H 3V4, Canada|The Hospital for Sick Children (SickKids), Toronto, Ontario, M5G 1X8, Canada|CHU Sainte-Justine, Montreal, Quebec, H3T 1C5, Canada|Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510000, China|Beijing Childrens Hospital, Capital Medical University, Beijing, 100045, China|Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, China|Fakultni nemocnice v Motole, Praha 5, 150 06, Czechia|Rigshospitalet, Dept Pediatrics & Adelescent Med., Copenhagen, 2100, Denmark|Institut Curie - Ulm - Paris, PARIS cedex 5, 75248, France|Institut Gustave Roussy - Département de Médecine Oncologique, Villejuif Cedex, 94805, France|Universitätsklinikum Heidelberg, Heidelberg, Baden-Württemberg, 69120, Germany|KLINIKUM STUTTGART - Olgahospital | Paediatrie 5 (Onkologie, Haematologie, Immunologie), Stuttgart, Baden-Württemberg, 70174, Germany|Charité - Campus Virchow-Klinikum (CVK), Berlin, 13353, Germany|Our Ladys Hospital For Sick Children, Crumlin, Dublin, 12, Ireland|Clalit Health Services Schneider Childrens Medical Center, Petach Tikva, 4920235, Israel|Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, 20133, Italy|Kanagawa Childrens Medical Center, Yokohama, Kanagawa, 232-8555, Japan|National Cancer Center Hospital, Chuo-ku, Tokyo, 104-0045, Japan|Kyushu University Hospital, Fukuoka, 812-8582, Japan|Seoul National University Hospital, Seoul, Seoul Teugbyeolsi, 3080, Korea, Republic of|Prinses Maxima Centrum, Utrecht, 3584 CS, Netherlands|Uniwersyteckie Centrum Kliniczne, Gdansk, 80-952, Poland|Ciutat Sanitaria i Universitaria de la Vall dHebron, Barcelona, 08035, Spain|Karolinska Universitetssjukhuset i Solna, Stockholm, 171 76, Sweden|Universitätskinderspital Zürich, Zürich, 8032, Switzerland|Istanbul Universitesi Istanbul Tip Fakultesi, Istanbul, 34093, Turkey|Western Ukrainian Specialized Pediatric Medical Centre, Lviv, 79035, Ukraine|Royal Marsden NHS Trust (Surrey), Sutton, Surrey, SM2 5PT, United Kingdom

{ "Larotrectinib": [ { "intervention_type": "DRUG", "description": "Larotrectinib (Vitrakvi, BAY2757556)", "name": "Larotrectinib", "synonyms": [ "VitrakviI", "Larotrectinib", "Vitrakvi" ], "medline_plus_id": "a619006", "generic_names": [ "Larotrectinib" ], "drugbank_id": "DB14723", "wikipedia_url": "https://en.wikipedia.org/wiki/Larotrectinib" } ] }

NCT00428987

Physical and Behavioral Traits of Overweight and Obese Adults

https://clinicaltrials.gov/study/NCT00428987

RECRUITING

This study will describe the phenotype (physical and behavioral traits) of overweight and obese people. It will characterize the hormones, metabolism, food preferences, fitness and physical activity levels, sleep patterns and thought processes in people with and without weight problems. Genetic material will be collected for studies of the internal codes that influence body weight. People over 18 years of age from all weight categories (lean, overweight, obese) who are reasonably healthy may be eligible for this study. Participants undergo the following tests and procedures: * Physical exam, electrocardiogram, blood and urine tests, instructions for recording food intake for 7 days * Metabolic studies for menstruating women. * Resting metabolic rate to study how many calories the body burns at rest. * Mixed meal test to measure hormones such as insulin that regulate blood sugar. * Glucose tolerance test to determine how sensitive the body is to insulin. * 24-hour energy expenditure to measure the amount of oxygen breathed in and the amount of carbon dioxide breathed out. * Repeat 24-hour energy expenditure. * Diurnal blood sampling and temperature assessment to study the body s internal clock. * Air-displacement plethysmography (Bod Pod) to measure body composition. * Dual energy x-ray absortiometry (DEXA) to measure body fat and bone density. * Repeat Bod Pod and DEXA. * Anthropometric measurements and bioelectrical impedance to measure height, weight, and circumferences, skinfold thickness, fluid status and percentage body fat. * Bromide dilution to measure the amount of water not in cells in the body. * Doubly labeled water to measure the amount of calories burned in a 7-day period. * 24-hour diet reports. * Endothelial reactivity to measure how the blood vessels stretch or dilate for assessing cardiovascular health. * Treadmill or bicycle exercise capacity test. * Physical activity monitor. * Unicorder to detect any breathing difficulties that may interfere with sleep. * Fat and muscle biopsy to look for variations in gene expression in fat tissue and muscle. * Neurocognitive testing to check memory, decision-making, hand-eye coordination, and reasoning. * Evaluation of mood problems and assess personality type. * Evaluation to assess the quantity and quality of pain experienced. * Taste testing to determine the response to bitter, salty, sweet and sour substances. * Occupational therapy evaluation to explore the subject s adaptations, if any, for performing personal, social or professional activities; the subject s views on his or her weight, body size and shape, and strategies to control weight.

NO

Obesity|Healthy Volunteers

Phenotype (physical and behavioral traits) of overweight and obese people, The aim of this study is to extensively phenotype subjects with varying degrees of obesity, as well as those with rare adipose disorders such as multiple symmetric lipomatosis (Madelung s disease), Dercums disease (adiposis dolorosa) and lipedema; to assess their hormonal, metabolic, cognitive and behavioral traits., Two weeks

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

ALL

ADULT, OLDER_ADULT

NIH

OBSERVATIONAL

Observational Model: |Time Perspective: p

070077|07-DK-0077

2007-03-08

2007-01-30

2024-06-10

National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States

{}

NCT04770987

Lateral Neck Flexor Endurance and Hyperlaxity

https://clinicaltrials.gov/study/NCT04770987

COMPLETED

The lateral neck flexor endurance test has been proposed to assess for unilateral muscular deficits. It is not known if individuals with hyperlaxity have different muscular endurance than individuals without hyperlaxity.

NO

Physical Endurance|Hypermobility, Joint|Muscular Weakness

OTHER: lateral neck flexor endurance test

lateral neck flexor endurance, maximum hold time, single testing session at enrollment

Beighton Hyperlaxity Scale, Assessment of systemic hyperlaxity, 0-9 points, higher indicates greater hyperlaxity, at enrollment|Neck Disability Index, Questionnaire assessing impact of neck symptoms on function, 0-100 points, higher score indicates greater disability, at enrollment|Numeric pain rating scale, assessment of neck pain, 0-10 with higher indicating greater levels of pain, at enrollment

University of Hartford

ALL

ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

PRO02021000205

2021-02-26

2021-07-16

2021-07-16

2021-02-25

2021-07-22

University of Hartford, West Hartford, Connecticut, 06117, United States

{ "lateral neck flexor endurance test": [ { "intervention_type": "OTHER" } ] }

NCT01344187

Safety and Efficacy Study of Corneal Collagen Cross-Linking in Eyes With Keratoconus

https://clinicaltrials.gov/study/NCT01344187

COMPLETED

The objectives of this study are to evaluate the safety and efficacy of corneal collagen cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as compared to placebo in impeding the progression of, and/or reducing, maximum corneal curvature.

NO

Keratoconus

DRUG: riboflavin solution|DRUG: placebo solution|DEVICE: KXL System

Mean change in maximum corneal curvature (Kmax) between the VibeX active treatment group and placebo control group, baseline to 6 months

Mean change in maximum corneal curvature (Kmax) between the VibeX active treatment group and placebo control group, baseline to 12 months

Glaukos Corporation

ALL

CHILD, ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

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

KXL-001

2012-07

2015-06

2016-06

2011-04-29

2021-04-26

UC Irvine Department of Ophthalmology, Irvine, California, 92697, United States|Bascolm Palmer Eye Institute, Miami, Florida, 33136, United States|Emory Eye Center, Atlanta, Georgia, 30342, United States|Ophthalmic Consultants of Boston, Waltham, Massachusetts, 02451, United States|Kugler Vision, Omaha, Nebraska, 68144, United States|Pinceton Eye Goup, Princeton, New Jersey, 08540, United States|Comprehensive Eye Care of Central Ohio, Westerville, Ohio, 43082, United States|Medical University of South Carolina Storm Eye Institute, Magill Vision Center, Mount Pleasant, South Carolina, 29464, United States|Vance Thompson Vision, Sioux Falls, South Dakota, 57108, United States|Hoopes Vision, Draper, Utah, 84020, United States

{ "riboflavin solution": [ { "intervention_type": "DRUG" } ], "placebo solution": [ { "intervention_type": "DRUG" } ], "KXL System": [ { "intervention_type": "DEVICE" } ] }

NCT00322387

Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkins Lymphoma Patients

https://clinicaltrials.gov/study/NCT00322387

COMPLETED

Patients with multiple myeloma (MM) and non-Hodgkins lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if it can increase the circulating levels of peripheral blood stem cells (PBSCs) by ≥ 2-fold before apheresis, and if transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).

YES

Lymphoma, Non-Hodgkin|Multiple Myeloma

DRUG: G-CSF and plerixafor

Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant, Safety assessment was based on the incidence of adverse event reports. Participant count of AEs (Adverse Events) by severity and by relationship to study drug. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment., 13 months

Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL, The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL)., Days 4-5 (first dose of plerixafor to apheresis)|Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant, Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment., 2 months

Genzyme, a Sanofi Company

ALL

ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

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

AMD3100-2104

2004-04

2006-07

2006-07

2006-05-05

2010-07-14

2014-03-13

City of Hope National Medical Center, Duarte, California, United States|Indiana Blood and Marrow Transplantation, Beech Grove, Indiana, United States|University of Rochester Medical Center, Rochester, New York, United States|Oregon Health and Science University, Portland, Oregon, United States|Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

{ "Filgrastim": [ { "intervention_type": "DRUG", "description": "G-CSF and plerixafor", "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" } ], "Plerixafor": [ { "intervention_type": "DRUG", "description": "G-CSF and plerixafor", "name": "Plerixafor", "synonyms": [ "1,1'-(1,4-phenylenebis(methylene))bis-1,4,8,11-tetraazacyclotetradecane", "1,4,8,11-tetraazacyclotetradecane, 1,1'-(1,4-phenylenebis(methylene))bis-", "Plerixafor", "Mozobil" ], "medline_plus_id": "a609018", "generic_names": [ "Plerixafor" ], "drugbank_id": "DB06809" } ] }

NCT00343187

A Phase II Study of ACZONE™ (Dapsone) Gel, 5% As a Treatment For Tarceva® (Erlotinib)Related Rash

https://clinicaltrials.gov/study/NCT00343187

TERMINATED

The purpose of this study is to evaluate the safety and preliminary efficacy of ACZONE in subjects treated with the HER1/EGFR inhibitor Tarceva (erlotinib) who develop a rash on the face

NO

Rash|Non-small-Cell Lung Cancer

DRUG: ACZONE (dapsone) Gel, 5%|DRUG: Vehicle Control

Safety: Adverse events; laboratory parameters; Vital signs; Pharmacokinetics

Efficacy: Lesion counts; Plaque area; % of FSA affected; Erythema Score; Pruritus VAS Score; CTCAE v3.0 Grade for rash; Proportion of subjects who have rash on the face that worsens to specific category.

Allergan

ALL

ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT

ACZ EGFR 01

2006-06

2007-07

2007-07

2006-06-22

2011-05-30

Northwestern University Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois, 60611-2941, United States|Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033, United States|Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111, United States

{ "Dapsone": [ { "intervention_type": "DRUG", "description": "ACZONE (dapsone) Gel, 5%", "name": "Dapsone", "synonyms": [ "Avlosulfone", "Bis(p-aminophenyl) sulfone", "4-aminophenyl sulfone", "4,4'-Sulfonylbisbenzeneamine", "4,4'-sulfonyldianiline", "1,1'-Sulfonylbis[4-aminobenzene]", "4,4'-Diaminodiphenylsulfone", "Dapsona", "Aczone", "DDS", "4,4'-Diaminodiphenyl sulphone", "Disulone", "bis(4-aminophenyl)sulfone", "Dapson-Fatol", "Diaminodiphenylsulfone", "p,p-sulphonylbisbenzamine", "p,p'-diaminodiphenyl sulfone", "4-(4-aminophenylsulfonyl)benzenamine", "4-(4-amino-benzenesulfonyl)-phenylamine", "Sulfona", "Dapsone", "4,4'-Diaminophenyl Sulfone", "DADPS", "4,4'-dapsone", "p,p-sulphonylbisbenzenamine", "Sulfone, 4,4'-Diaminophenyl", "Sulfonyldianiline", "4,4'-diaminodiphenyl sulfone", "Dapsoderm-X", "4,4' Diaminophenyl Sulfone", "p-aminophenyl sulfone", "Dapsonum", "Diaphenylsulfone", "4,4'-Sulfonyldianilin", "4,4'-Sulfonylbisbenzenamine", "4-(4-aminophenylsulfonyl)aniline", "1,1'-sulfonylbis(4-aminobenzene)", "4,4'-sulfonylbisaniline" ], "medline_plus_id": "a616045", "generic_names": [ "Dapsone" ], "mesh_id": "D007917", "drugbank_id": "DB00250", "wikipedia_url": "https://en.wikipedia.org/wiki/Dapsone" } ], "Vehicle Control": [ { "intervention_type": "DRUG" } ] }

NCT02468687

NMP in Relapsed / Refractory Myeloma

https://clinicaltrials.gov/study/NCT02468687

COMPLETED

The study will evaluate if the N-methyl-pyrrolidone (NMP) can be safely administered to humans at doses, which induce measurable immunological and anti-tumour effects in patients with myeloma who are resistant to or intolerant of lenalidomide and bortezomib.

NO

Multiple Myeloma

DRUG: N-methyl-pyrrolidone

Adverse events to establish the Maximum Tolerated Dose (MTD), Each patient will be monitored for adverse events during the first cycle of NMP treatment (28 days) to establish the maximum tolerated dose, 28 days

Optimum biological dose (OBD), The maximum changes in correlative biomarkers will be tested at the specific time-points. Descriptive statistics will be used to analyse data from correlative studies and summarized in graphical or tabular formats as appropriate., 6 months|Safety of the repeated dosing of NMP by oral administration - possible toxicities, To assess safety, the numbers and rates (with confidence intervals) of patients experiencing any haematological and non-haematological and specific grade 3+ adverse events experienced at each given dose level and schedule of NMP will be calculated, over the full treatment period and by cycle, 6 months|Pharmacokinetic properties of NMP after oral administration, Pick plasma concentrations (Cmax) of NMP, Predose,0.5,1,2,4,8, 24 hours post dose|Response rate measured using IMWG criteria, Patients will be evaluated for response after every 28 day cycle for the first 6 cycles of treatment and thereafter every 2 months in follow up using the IMWG criteria for multiple myeloma., 6 months up to 2 years|Time to progression from start of treatment, Patients will be assessed for disease progression weekly in Cycle 1, then monthly on D1 of each cycle during treatment for the first 6 months and then monthly until disease progression, next anti-cancer treatment or death. Time to progression from start of treatment will be estimated using Kaplan Meier survival curves., up to 3.5 years

Peter MacCallum Cancer Centre, Australia

Melbourne Health

ALL

ADULT, OLDER_ADULT

PHASE1

OTHER

INTERVENTIONAL

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

HREC/14/MH/159

2015-08-20

2021-10-07

2021-10-07

2015-06-11

2022-05-05

Peter MacCallum Cancer Centre, Melbourne, Victoria, 3002, Australia

{ "Methyl pyrrolidone": [ { "intervention_type": "DRUG", "description": "N-methyl-pyrrolidone", "name": "Methyl pyrrolidone", "synonyms": [ "N-methyl-2-pyrrolidone", "1-methyl-2-pyrrolidinone", "1-methylpyrrolidinone", "Methyl pyrrolidone", "1-methyl-2-pyrrolidone", "N-methylpyrrolidone", "NMP", "N-methyl-pyrrolidone", "1-methyl-5-pyrrolidinone", "Methylpyrrolidone" ], "drugbank_id": "DB12521", "generic_names": [ "Methyl pyrrolidone" ] } ] }

NCT05911087

A Phase II/III Study to Evaluate the Immunogenicity and Safety and Efficacy of SWIM816 Vaccines for SARS-CoV-2

https://clinicaltrials.gov/study/NCT05911087

NOT_YET_RECRUITING

Primary Immunogenicity Objective：Cohort 1: GMTs of SARS-CoV-2 Omicron and related strain neutralizing antibody levels for SWIM816.Cohort 2: To demonstrate the non- inferiority of neutralizing antibody response in terms of geometric mean titers (GMT) of COVID-19 mRNA vaccine(SWIM816) compare with mRNA COVID-19 vaccine(Pfizer Bivalent vaccine) 14 days post dose. Primary Safety Objective：To assess the reactogenicity and safety of a booster dose in a heterologous vaccination regimen in subjects previously immunized with 2/3 doses of COVID-19 vaccine with or without previously diagnosed with COVID-19. Secondary Immunogenicity Objectives：To describe the neutralizing antibody response at D29, D91 and D181.To describe binding antibody profile at D01, D15, D29, D91 and D181 of each study group. Secondary Safety Objective：To assess the reactogenicity and safety of third or fourth booster dose in a heterologous vaccination regimen in subjects previously immunized with 2/3 COVID-19 vaccine doses. Exploratory Objective：1.Documented confirmed SARS-CoV-2 symptomatic infection；2.Todemonstrate the cellular immune response profile at study group (30 subjects per each group for cellular immune testing).

NO

Immunogenicity|Safety

BIOLOGICAL: Phase II:SWIM816;SARS-Cov-2;|BIOLOGICAL: Phase II:SW-BIC-213;SARS-Cov-2;|BIOLOGICAL: PhaseIII:SWIM816;SARS-Cov-2;|BIOLOGICAL: PhaseIII:Pfizer(Pfizer Bivalent vaccine);SARS-Cov-2；

Phase II :Immunogenicity, GMTs of SARS-CoV-2 Omicron and related strain neutralizing antibody levels for SWIM816., 15 days after study vaccination|Phase II :Immunogenicity, To demonstrate the non- inferiority of neutralizing antibody response in terms of geometric mean titers (GMT) of COVID-19 mRNA vaccine(SWIM816) compare with mRNA COVID-19 vaccine(Pfizer Bivalent vaccine) 14 days post dose., 14 days post dose

Stemirna Therapeutics

ALL

ADULT, OLDER_ADULT

PHASE2|PHASE3

INDUSTRY

INTERVENTIONAL

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

SWP2023-1

2023-06-20

2023-07-31

2024-02-01

2023-06-20

2023-06-20

{ "Phase II:SWIM816;SARS-Cov-2;": [ { "intervention_type": "BIOLOGICAL" } ], "Phase II:SW-BIC-213;SARS-Cov-2;": [ { "intervention_type": "BIOLOGICAL" } ], "PhaseIII:SWIM816;SARS-Cov-2;": [ { "intervention_type": "BIOLOGICAL" } ], "PhaseIII:Pfizer(Pfizer Bivalent vaccine);SARS-Cov-2\uff1b": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT03872687

The Effectiveness of Single Tufted Brush in the Management of Peri-implant Mucositis

https://clinicaltrials.gov/study/NCT03872687

UNKNOWN

The study aims to investigate and compare the reduction in (1) soft tissue inflammation and (2) amount of plaque accumulation at implant sites with (test) or without (control) patient administered use of single tufted brush. Stratified randomized single blinded clinical controlled trial with 2 parallel arms is designed to achieve the aims of this research project. Study participants will be enrolled from NUH University Dental Cluster. They will be randomly assigned into the test (toothbrush, interdental brush, and single tufted brush) and control (toothbrush and interdental brush) groups and reviewed at 2 weeks (± 3 days), 4 weeks (± 3 days), 3 months (± 7 days), and 6 months (± 7 days).

NO

Dental Implant

DEVICE: single tufted brush with IDB|DEVICE: interdental brushes

the reduction in bleeding tendency, The reduction in bleeding tendency as assessed by mBI at 6 sites per implant, baseline, 2-weeks, 1 month, 3 months, and 6 months post instrumentation

the reduction in plaque accumulation, The reduction in plaque accumulation with a modified Plaque Index (mPI) at 8 sites (mesiobuccal, mesial, mesiolingual, lingual, distolingual, distal, distobuccal, and buccal) per implant, baseline, 2-weeks, 1 month, 3 months, and 6 months post instrumentation

National University Health System, Singapore

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

2018/01174

2019-06-07

2020-12-31

2020-12-31

2019-03-13

2019-03-13

{ "single tufted brush with IDB": [ { "intervention_type": "DEVICE" } ], "interdental brushes": [ { "intervention_type": "DEVICE" } ] }

NCT02832687

Multi-dose Acetaminophen for Patients Undergoing General Anesthesia

https://clinicaltrials.gov/study/NCT02832687

TERMINATED

Study Objective The aim of the proposed study is to examine the effect of Q4 hour multidose IV acetaminophen on patients readiness for discharge. In doing so the investigators will also investigate the various factors that could potentially contribute to a patients readiness for discharge such as overall opioid consumption, time to rescue medication, incidence of postoperative nausea and vomiting, pain scores, and perioperative stress markers and their overall correlation with IV acetaminophen intake.

YES

Recovery Following Cholecystectomy

DRUG: Acetaminophen|DRUG: normal saline

Readiness for Discharge, Number (percentage) of Participants with Readiness for Discharge (achieving discharge-readiness status at end of 2- hours post-surgery evaluated using the SPEEDs criteria: oxygen saturation, pain control, emesis control, extremity movement, dialogue, and stable vital signs., 2 hours following surgery

Post Operative Pain Scores, Pain scores every 15 min for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour. Visual Analogue Scale (VAS) for pain was used: score on a scale from 0 (no pain) to 10 (worst pain) were recorded., Every 15 min for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour|Plasma Stress Markers, Concentration of the plasma stress markers including epinephrine, norepinephrine, cortisol, interleukins (IL) 6, 8 and 10., Before administration of any drug (after placement of intravenous (IV) line), before surgical incision (in operating room (OR)), and 1 h after arrival in post-anesthesia care unit (PACU)|The Level of C-reactive Protein, Concentration of the plasma C-reactive protein (CRP), Before administration of any drug (after placement of intravenous (IV) line), before surgical incision (in operating room (OR)), and 1 h after arrival in post-anesthesia care unit (PACU)|Time to Rescue Pain Medication, Time to the first dose of pain medication, From arrival in PACU to the first dose of pain medication is given during 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour.|Total Dosage of Post Operative Opioids, Total dosage of post operative opioids (hydromorphone), From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour.|Patient Satisfaction Survey, Survey asking patients about their satisfaction with the experience, pain control, and anesthetic rated on a 5 point Likert scale, with 1 being dissatisfied/unlikely and 5 being most satisfied/very likely. Subscales were summed to receive total score., For patients going home the day of surgery the survey is given prior to departing the hospital (approx 5 hours post surgery). For those being admitted, the survey is given once discharge criteria are met in the PACU (approx 3 hours post surgery).|Number of Participants With Post Operative Nausea and Vomiting, Number of Participants with Post Operative Nausea and Vomiting, From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour|Number of Participants Requiring Additional Anti-emetics, Number of Participants Requiring Additional Anti-emetics (anti-vomiting), From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour

Rutgers, The State University of New Jersey

Mallinckrodt

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

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

20150002613

2017-06-19

2020-09-01

2020-12-31

2016-07-14

2021-12-09

2021-12-09

New Jersey Medical School, Newark, New Jersey, 07103, United States|University Hospital, Newark, New Jersey, 07103, United States|New York Methodist Hospital, Brooklyn, New York, 11215, United States

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT02832687/Prot_SAP_001.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/87/NCT02832687/ICF_000.pdf

{ "Acetaminophen": [ { "intervention_type": "DRUG", "description": "Acetaminophen", "name": "Acetaminophen", "synonyms": [ "Parac\u00e9tamol", "4-(Acetylamino)phenol", "p-Acetamidophenol", "Acetominophen", "Anacin 3", "Paracetamolum", "p-hydroxyphenolacetamide", "Actamin", "Hydroxyacetanilide", "N-acetyl-p-aminophenol", "Datril", "4'-hydroxyacetanilide", "p-acetaminophenol", "Acetaco", "p-acetamidophenol", "Neopap Supprettes Rectal Suppository", "Acetaminophen", "N-(4-Hydroxyphenyl)acetanilide", "APAP", "Ac\u00e9taminoph\u00e8ne", "Algotropyl", "Ofirmev", "p-hydroxyacetanilide", "N-Acetyl-p-aminophenol", "Acetaminof\u00e9n", "Acamol", "p-Acetylaminophenol", "Panadol", "Paracetamol", "Acenol", "Tylenol", "Acetamidophenol", "p-hydroxy-acetanilid", "p-Hydroxyacetanilide", "4-acetamidophenol", "Anacin-3", "Anacin3", "Acephen Rectal Suppository", "Acephen", "Disprol", "- OtherDisprol", "Calpol", "Hedex", "Medinol", "Panadol", "Paracetamol", "Tylenol", "Disprol", "- OtherDisprol", "Calpol", "Hedex", "Medinol", "Panadol", "Paracetamol", "Tylenol", "Disprol", "- OtherDisprol", "Calpol", "Hedex", "Medinol", "Panadol", "Paracetamol", "Tylenol", "Acetaminophen and Codeine", "Capital", "Phenaphen", "Empracet", "Tylenol", "Disprol", "- OtherDisprol", "Calpol", "Hedex", "Medinol", "Panadol", "Paracetamol", "Tylenol", "Acetaminophen and Codeine", "Capital", "Phenaphen", "Empracet", "Tylenol", "Disprol", "- OtherDisprol", "Calpol", "Hedex", "Medinol", "Panadol", "Paracetamol", "Tylenol", "Disprol", "- OtherDisprol", "Calpol", "Hedex", "Medinol", "Panadol", "Paracetamol", "Tylenol" ], "medline_plus_id": "a621016", "generic_names": [ "Acetaminophen", "Acetaminophen and Codeine", "Acetaminophen and Codeine" ], "mesh_id": "D058633", "drugbank_id": "DB00316", "nhs_url": "https://www.nhs.uk/medicines/paracetamol-for-children" } ], "normal saline": [ { "intervention_type": "DRUG" } ] }

NCT03259087

Pharmacokinetics (PK) and Safety of a Single Intravenous (IV) Dose of MK-3866 in Participants With Impaired Renal Function and in Healthy Controls (MK-3866-005)

https://clinicaltrials.gov/study/NCT03259087

COMPLETED

The purpose of this study is to compare plasma and urine PK parameters of MK-3866 between participants with impaired renal function and healthy control participants, to investigate the extent to which MK-3866 is removed from the plasma by hemodialysis (HD), and evaluate the safety and tolerability of MK-3866 in participants with impaired renal function.

YES

Renal Impairment

DRUG: MK-3866

Part 1: Area Under the Plasma Concentration-time Curve of MK-3866 From Time Zero to Infinity (AUC0-inf), Plasma samples were collected at pre-specified time points and AUC0-inf was assessed. Plasma concentrations of MK-3866 were determined using high-performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS)., Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants|Part 1: Area Under the Plasma Concentration-time Curve of MK-3866 From Time Zero to the Time of the Last Quantifiable Sample (AUC0-last), Plasma samples were collected at pre-specified time points and AUC0-last was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS., Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants|Part 1: Area Under the Plasma Concentration-time Curve of MK-3866 From Time Zero to 24 Hours After Dosing (AUC0-24), Plasma samples were collected at pre-specified time points and AUC0-24 was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS., Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, and 24 hours after dosing on Day 1|Part 1: Plasma Concentration of MK-3866 at the End of the Infusion (Ceoi), Plasma samples were collected at pre-specified time points and Ceoi was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS., At the end of the infusion (0.5 hours after infusion start) on Day 1|Part 1: Maximum Plasma Concentration of MK-3866 (Cmax), Plasma samples were collected at pre-specified time points and Cmax was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS., Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants|Part 1: Plasma Clearance of MK-3866 (CL), Plasma samples were collected at pre-specified time points and CL was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS., Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants|Part 1: Time to Maximum Plasma Concentration of MK-3866 (Tmax), Plasma samples were collected at pre-specified time points and Tmax was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS., Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants|Part 1: Elimination Terminal Half-life of Plasma MK-3866 (t1/2), Plasma samples were collected at pre-specified time points and t1/2 was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric % coefficient of variation (%CV)., Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants|Part 1: Volume of Distribution of Plasma MK-3866 (Vz), Plasma samples were collected at pre-specified time points and Vz was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV., Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants|Part 2: AUC0-inf of Plasma MK-3866, Plasma samples were collected at pre-specified time points and AUC0-inf was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1., Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2|Part 2: AUC0-last of Plasma MK-3866, Plasma samples were collected at pre-specified time points and AUC0-last was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1., Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2|Part 2: AUC0-24 of Plasma MK-3866, Plasma samples were collected at pre-specified time points and AUC0-24 was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1., Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, and 24 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2|Part 2: Ceoi of Plasma MK-3866, Plasma samples were collected at pre-specified time points and Ceoi was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1., At the end of the infusion (0.5 hours after infusion start) on Day 1 of Period 1 and Period 2|Part 2: Cmax of Plasma MK-3866, Plasma samples were collected at pre-specified time points and Cmax was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1., Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2|Part 2: CL of Plasma MK-3866, Plasma samples were collected at pre-specified time points and CL was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1., Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2|Part 2: Tmax of Plasma MK-3866, Plasma samples were collected at pre-specified time points and Tmax was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1., Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2|Part 2: t1/2 of Plasma MK-3866, Plasma samples were collected at pre-specified time points and t1/2 was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1. Method of dispersion used for these data is geometric %CV., Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2|Part 2: Vz of Plasma MK-3866, Plasma samples were collected at pre-specified time points and Vz was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1. Method of dispersion used for these data is geometric %CV., Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2

Part 1: Total Amount of MK-3866 Excreted in the Urine Over 24 Hours (Ae0-24), Urine samples were collected at pre-specified intervals and Ae0-24 was assessed. Ae0-24 was obtained by adding the amounts excreted over each collection interval. Urine concentrations of MK-3866 were determined using HPLC-MS/MS., Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1|Part 1: Renal Clearance (CLr) of MK-3866, Urine samples were collected at pre-specified intervals and CLr was assessed. CLr was calculated as AE(t-t )/AUC(t-t ), where t-t is the longest interval of time during which AE and AUC are both obtained. Urine concentrations of MK-3866 were determined using HPLC-MS/MS., Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1|Part 1: Fraction of MK-3866 Excretion (Urine) During Each Collection Interval (Fe0-24), Urine samples were collected at pre-specified intervals and Fe0-24 was assessed. Fe0-24 was obtained by dividing the amount of MK-3866 excreted in each collection interval by the dose. Urine concentrations of MK-3866 were determined using HPLC-MS/MS., Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1|Part 2: Total Amount of MK-3866 Excreted Unchanged in the Urine Over the Period of 24 Hours (Ae0-24), Urine samples were collected at pre-specified intervals and Ae0-24 was assessed. Ae0-24 was obtained by adding the amounts excreted over each collection interval. Urine concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV., Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1 of Period 1 and Period 2|Part 2: Renal Clearance (CLr) of MK-3866, Urine samples were collected at pre-specified intervals and CLr was assessed. CLr was calculated as AE(t-t )/AUC(t-t ), where t-t is the longest interval of time during which AE and AUC are both obtained. Urine concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV., Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1 of Period 1 and Period 2|Part 2: Fraction of MK-3866 Excretion (Urine) During Each Collection Interval (Fe0-24), Urine samples were collected at pre-specified intervals and Fe0-24 was assessed. Fe0-24 was obtained by dividing the amount of MK-3866 excreted in each collection interval by the dose. Urine concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV., Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1 of Period 1 and Period 2|Part 2: Concentration of MK-3866 in Plasma Entering the Dialyzer Line (Ca), Plasma samples entering the dialyzer line were collected at pre-specified time points and Ca was assessed. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV., 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|Part 2: Concentration of MK-3866 in Plasma Exiting the Dialyzer Line (Cv), Plasma samples exiting the dialyzer line were collected at pre-specified time points and Cv was assessed. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV., 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|Part 2: Area Under the Concentration-time Curve of MK-3866 in Plasma Entering the Dialyzer Line During the Dialysis Period (AUCD), Plasma samples entering the dialyzer line were collected at pre-specified time points and AUCD was assessed. AUCD values were determined from the Ca versus time profile during the HD period, using the linear up, log down calculation method. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV., 0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|Part 2: Area Under the Concentration-time Curve of MK-3866 in Plasma Entering the Dialyzer Line From 0.75 to 4.5 Hours During the Dialysis Period (AUC[0.75-4.5]Ca), Plasma samples entering the dialyzer line were collected at pre-specified time points and AUC[0.75-4.5]Ca was assessed. AUC[0.75-4.5]Ca values were determined from the Ca versus time profile from 0.75 to 4.5 hours during the HD period, using the linear up, log down calculation method. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV., 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|Part 2: Area Under the Concentration-time Curve of MK-3866 in Plasma Entering the Dialyzer Line From 0.75 to 4.5 Hours During the Dialysis Period (AUC[0.75-4.5]Cv), Plasma samples entering the dialyzer line were collected at pre-specified time points and AUC[0.75-4.5]Cv was assessed. AUC[0.75-4.5]Cv values were determined from the Cv versus time profile from 0.75 to 4.5 hours during the HD period, using the linear up, log down calculation method. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV., 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|Part 2: Dialysis Clearance of MK-3866 Based on Plasma (CLD,Plasma), Plasma dialysis samples were collected at pre-specified time points and CLD was assessed. CLD was calculated as Q x R x (AUC[1-4.5]Ca - AUC[1-4.5]Cv) / AUC[1-4.5]Ca, where Q is the flow rate of blood through the dialyzer, and R is the ratio of blood drug concentration to plasma drug concentration. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV., 0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|Part 2: Concentration of MK-3866 in Dialysate Samples (CD), Plasma dialysis samples were collected at pre-specified time points and CD was assessed. Concentrations of MK-3866 were determined using HPLC-MS/MS., 0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|Part 2: Amount of MK-3866 Recovered From Each Dialysate Sample (AD), Plasma dialysis samples were collected at pre-specified time points and AD was assessed. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV., 0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|Part 2: Rate of Removal of MK-3866 From the Dialysate (rr), Plasma dialysis samples were collected at pre-specified time points and rr was assessed. rr was calculated as CD x dialysate flow rate. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV., 0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|Part 2: Cumulative Amount of MK-3866 Recovered From the Dialysate (AD,Total), Plasma dialysis samples were collected at pre-specified time points and AD,total was assessed. AD,total was obtained by integrating the rr versus time profile over the dialysis session duration, using actual times relative to the start time of dialysis. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV., 0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|Part 2: Hemodialysis Clearance of MK-3866 Based on the Dialysate(CLD,Dialysate), Plasma dialysis samples were collected at pre-specified time points and CLD,dialysate was assessed. CLD,dialysate was calculated as AD.total / AUCD. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV., 0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|Number of Participants With at Least One Adverse Event (AE), An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsors product, is also an AE., Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing|Number of Participants Discontinuing the Study Due to an Adverse Event, An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsors product, is also an AE., Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing

Merck Sharp & Dohme LLC

ALL

ADULT, OLDER_ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

3866-005|CA22640|MK-3866-005

2017-09-01

2018-01-28

2018-02-09

2017-08-23

2019-04-19

2019-04-19

Clinical Pharmacology of Miami ( Site 0001), Hialeah, Florida, 33014, United States|Orlando Clinical Research Center ( Site 0002), Orlando, Florida, 32809, United States

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT03259087/Prot_SAP_000.pdf

{ "MK-3866": [ { "intervention_type": "DRUG" } ] }

NCT05095987

Evaluation of One Day Discharge After Laparoscopic Appendectomy for Uncomplicated Appendicitis in Children.

https://clinicaltrials.gov/study/NCT05095987

COMPLETED

The aim of this study was to evaluate the value and safety of discharge of a child to home care within 24 hours after laparoscopic appendectomy for uncomplicated appendicitis to reduce the impact on the childs psyche and need for hospitalisation. Baseline demographic data and intraoperative finding will be recorded. Parents are given a two-page questionnaire that is completed in three cycles (immediately after discharge, daily until the first control and immediately before the first control). All data will be statistically processed using descriptive statistics.

NO

Appendicitis Acute

PROCEDURE: Laparoscopic Appendectomy

Safety of one day discharge after laparoscopic Appendectomy, Safety of one day discharge after laparoscopic appendectomy for uncomplicated acute appendicitis in children. It will be measured by readmission rate of the early discharged children (within 24 hours from surgery). If there is no readmissions then the one day discharge after laparoscopic appendectomy for uncomplicated acute appendicitis in children would be considered safe. Again, the condition of an operated child is monitored and followed-up in an outpatient clinic 1 week after the surgery. The parental notes, and observations are taken into account., 4 weeks

Parental Satisfaction, Using a questionnaire to evaluate parental satisfaction. There are four parts of the questionnaire: First part of the questionnaire 3 level scoring in satisfaction in agreeing of one day discharge after the surgery (the very first day), second part is structured as a simple yes/no answer possibility of childs behaviour and pain at home. The third part is a child pain score from 0-10, 0 being no pain and 10 greatest unbearable pain and parental-child pain management (used medicine, etc...). Finally, fourth part is modified first part where there is 3 level scoring in satisfaction in agreeing of one day discharge after the surgery, but now one week after., 1 week

Readmission rate, Readmission rate to the hospital due to the laparoscopic appendectomy., 2 weeks|Complication rate, Complication due to surgical intervention, 2 weeks|Cost reduction, due to shorter hospital stay the study anticipates a cost reduction, 2 weeks

Miro Jukić

ALL

CHILD, ADULT

OTHER

INTERVENTIONAL

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

UHSplitpedsurg

2021-10-02

2022-06-01

2022-07-01

2021-10-27

2022-07-20

University hospital of Split, Split, Splitsko Dalmatinska Županija, 21000, Croatia

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT05095987/Prot_SAP_000.pdf

{ "Laparoscopic Appendectomy": [ { "intervention_type": "PROCEDURE" } ] }

NCT00058487

Epirubicin and Thalidomide in Treating Patients With Liver Cancer

https://clinicaltrials.gov/study/NCT00058487

COMPLETED

RATIONALE: Drugs used in chemotherapy such as epirubicin use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of hepatocellular (liver) cancer by stopping blood flow to the tumor. Combining epirubicin with thalidomide may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining epirubicin with thalidomide in treating patients who have unresectable or metastatic liver cancer.

NO

Liver Cancer

DRUG: epirubicin hydrochloride|DRUG: thalidomide

Antitumor activity|Toxic effects

Dana-Farber Cancer Institute

National Cancer Institute (NCI)

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

DFCI-01281|CDR0000298783|CELGENE-2001-P-00170/1

2001-12

2007-01

2003-04-09

2013-07-18

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, 02114, United States|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States

{ "Epirubicin": [ { "intervention_type": "DRUG", "description": "epirubicin hydrochloride", "name": "Epirubicin", "synonyms": [ "4'-Epiadriamycin", "EPIcell", "NSC256942", "NSC-256942", "(1S,3S)-3-GLYCOLOYL-1,2,3,4,6,11-HEXAHYDRO-3,5,12-TRIHYDROXY-10-METHOXY-6,11-DIOXO-1-NAPHTHACENYL 3-AMINO-2,3,6-TRIDEOXY-.ALPHA.-L-ARABINO-HEXOPYRANOSIDE", "4'-EPI-ADRIAMYCIN", "NSC 256942", "Farmorubicine", "Epirubicina", "Ellence", "IMI28", "4'-Epi-DXR", "4' Epi Doxorubicin", "5,12-NAPHTHACENEDIONE, 10-((3-AMINO-2,3,6-TRIDEOXY-.ALPHA.-L-ARABINO-HEXOPYRANOSYL)OXY)-7,8,9,10-TETRAHYDRO-6,8,11-TRIHYDROXY-8-(HYDROXYACETYL)-1-METHOXY-, (8S-CIS)-", "Pharmorubicin", "4' Epi Adriamycin", "4' Epidoxorubicin", "Hydrochloride, Epirubicin", "Farmorubicina", "Epilem", "Farmorubicin", "4'-Epi-Doxorubicin", "Epirubicin", "4'-Epi-Adriamycin", "Epirubicine", "Epiadriamycin", "4'-Epidoxorubicin", "EPI-cell", "Epirubicinum", "IMI 28", "Epirubicin Hydrochloride", "4' Epi DXR", "Pidorubicine", "Pidorubicinum", "Pidorubicina", "4' Epiadriamycin", "EPI cell", "epirubicin-conjugated polymer micelles", "IMI-28" ], "medline_plus_id": "a603003", "generic_names": [ "Epirubicin" ], "mesh_id": "D059005", "drugbank_id": "DB00445" } ], "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" } ] }

NCT01242787

Long-term Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B

https://clinicaltrials.gov/study/NCT01242787

LB80380

UNKNOWN

The purpose of the study is to investigate the long-term safety and the antiviral activity of the optimal doses of LB80380 for additional 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to entecavir 0.5 mg.

NO

Chronic Hepatitis B

DRUG: LB80380|DRUG: Entecavir 0.5 mg

Percentage of patients showing HBV DNA mutation, Safety assessment including adverse events, laboratory abnormalities and DNA mutation, at Week 48

Change of HBV DNA from Baseline of LG-BVCL007 study, Efficacy assessment including normalization of ALT, HBsAg seroconversion, HBeAg seroconversion, at Week 48

LG Life Sciences

ALL

ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

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

BVCL008

2010-08

2012-09

2012-09

2010-11-17

2012-04-16

Queen Mary Hospital, Hong Kong, China|Severance Hospital of Yonsei University and other 8 sites in Korea, Seoul, Korea, Republic of

{ "LB80380": [ { "intervention_type": "DRUG" } ], "Entecavir": [ { "intervention_type": "DRUG", "description": "Entecavir 0.5 mg", "name": "Entecavir", "synonyms": [ "Entecavir (anhydrous)", "Entecavir", "Entecavirum", "Anhydrous entecavir", "Baraclude", "Entecavir anhydrous" ], "medline_plus_id": "a605028", "generic_names": [ "Entecavir" ], "drugbank_id": "DB00442", "wikipedia_url": "https://en.wikipedia.org/wiki/Entecavir" } ] }

NCT02534987

Integrated Clinical Prediction Rules: Bringing Evidence to Diverse Primary Care Settings

https://clinicaltrials.gov/study/NCT02534987

iCPR2

COMPLETED

The study is a randomized controlled trial, with an Intervention Group and a Control Group at the University of Utah (U of U) and University of Wisconsin (UW). BU serves as the primary award and coordinating institution. The unit of randomization will be at the clinic level at each institution. UW will recruit all General Internal Medicine (GIM) Clinics and Department of Family Medicine (DFM) Clinics in Dane County as well as their East and West Urgent Care Clinics. U of U will recruit all affiliated primary care practices. The unit of randomization will be the clinic. The study biostatistician will receive a list of clinic sites that have agreed to participate in the study from the site PIs. Clinics will be randomized to either Intervention group or to a Control group stratified by clinic size. Both groups will receive a single 45 minute academic detailing session describing evidenced-based diagnosis and treatment for strep throat and pneumonia. The Intervention Group will also receive a demonstration of the iCPR tool during their academic detailing session. Providers and clinic staff will be invited to the academic detailing session. Any provider or staff that is unable to attend the session will receive written and electronic copies of the material. Individual providers will not be specifically recruited for participation and they will participate or not based on personal preferences as they would for any clinic quality improvement project. The iCPR tool will be turned on for providers in the Intervention group. This means that the best practice alerts will trigger for appropriate patients with suspected strep throat or pneumonia. We will collect and analyze data about the use of each element of the iCPR tool during patient visits, including which elements of the tool were used and how often. We will also collect data from the site EHRs about antibiotic and diagnostic test orders for strep throat and pneumonia from all clinics participating in the trial, both Intervention and Control groups. After one year of study implementation, we will run an Interim Primary Outcome Report comparing the antibiotic and diagnostic test orders between the Intervention and Control group clinics. This report will be in the aggregate and will not contain any personally-identifiable information. If there is a significant difference between the groups that meets our predetermined stopping end points, we will stop the randomized controlled trial.

NO

Strep Throat|Pneumonia

OTHER: iCPR2

overall rate of antibiotic prescribing, overall rate of antibiotic prescribing for strep and pneumonia, 2 years

NYU Langone Health

University of Utah|University of Wisconsin, Madison|North Shore University Hospital|National Institute of Allergy and Infectious Diseases (NIAID)

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

16-01240|5R01AI108680-01

2015-03

2018-06

2018-06

2015-08-28

2020-05-21

New York University School of Medicine, New York, New York, 10016, United States

{ "iCPR2": [ { "intervention_type": "OTHER" } ] }

NCT01653587

AngioSeal Versus Radial Approach in Acute Coronary Syndrome

https://clinicaltrials.gov/study/NCT01653587

ARISE

COMPLETED

Among non-ST-segment elevation acute coronary syndrome patients submitted to early invasive strategy and randomized for the transfemoral or transradial approach, the AngioSeal vascular closure device would decrease the prevalence of vascular complications at puncture site, reaching the non-inferiority criterion when compared to the radial access.

YES

Acute Coronary Syndrome

DEVICE: Percutaneous coronary intervention

First Occurrence of Access Site Related Ischemic or Bleeding Complication, Vascular and systemic complications at arterial puncture site include major bleeding, retroperitoneal hemorrhage, compartment syndrome, hematoma ≥ 5 cm, pseudoaneurysm, arteriovenous fistula, infection, limb ischemia, asymptomatic arterial occlusion, adjacent nerve injury or need for vascular surgery repair., 30 days

Adverse Ischemic or Bleeding Events, Individual components of the primary objective, hematoma < 5 cm, cardiovascular death, myocardial infarction, stroke, major bleeding unrelated to puncture site or to coronary artery bypass grafting, device success and crossover rate between techniques, 30 days

Cardiovascular Death, Myocardial Infarction or Stroke, 12 months

Irmandade Santa Casa Misericórdia Marília

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

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

ISCMM-01|PBA-1

2012-07

2015-03

2016-03

2012-07-31

2018-10-09

2018-12-05

Irmandade da Santa Casa de Misericórdia de Marília, Marília, São Paulo, 17515900, Brazil

{ "Percutaneous coronary intervention": [ { "intervention_type": "DEVICE" } ] }

NCT04965987

Oxaloacetate in Myasthenia Gravis

https://clinicaltrials.gov/study/NCT04965987

UNKNOWN

This is a phase 1 clinical trial studying whether or not oxaloacetate has a positive effect on patients with Myasthenia Gravis. Patients will be assigned to one of three cohorts which will determine the dose of oxaloacetate they will be given. Subjects will take the study drug for 4 weeks and be on placebo for 4 weeks.

NO

Myasthenia Gravis

DRUG: Oxaloacetate|DRUG: Placebo

Safety (Frequency and Severity of Adverse Events), The primary endpoint of safety will be reported as counts of subjects experiencing adverse events events (including abnormal laboratory results and vital signs). Measures of safety will be reported for the last visit observed for each participant., At weeks 2, 4, 6, 8, 10, and 12

Myasthenia Gravis-specific Activities of Daily Living Scale (MG-ADL) Score, Myasthenia Gravis-specific Activities of Daily Living scale (MG-ADL): Composite measure of scores from measurement scales. The MG-ADL has a scale of 0 - 24 with 0 being the lowest (no symptoms) and 24 being the highest (most severe symptoms. The MG-ADL is a staff-administered, patient-reported questionnaire that measures 8 commons symptoms of myasthenia gravis and grades them on a scale of 0 - 3., Change from Week 4 to Week 8|Quantitative Myasthenia Gravis (QMG) Score, The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The scale is from 0 - 3 for each item, with 0 meaning normal and 3 is severe. Total score can range from 0 to 39., Change from Week 4 to Week 8

University of Kansas Medical Center

Terra Biological LLC

ALL

ADULT, OLDER_ADULT

PHASE1

OTHER

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

MG OAA

2021-10

2023-04

2023-04

2021-07-16

2021-07-16

University of Kansas Medical Center, Kansas City, Kansas, 66160, United States

{ "Oxaloacetic acid": [ { "intervention_type": "DRUG", "description": "Oxaloacetate", "name": "Oxaloacetic acid", "synonyms": [ "Oxalacetic acid trans-(z)-enol form", "Ketosuccinic acid", "Oxalacetic acid", "Anhydrous enol-oxaloacetate", "Oxaloacetate", "Bioepg", "2-oxobutanedioic acid", "Oxaloacetic acid", "Oxosuccinic acid" ], "drugbank_id": "DB16921", "generic_names": [ "Oxaloacetic acid" ] } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT04183387

Simvastatin in Uveitis

https://clinicaltrials.gov/study/NCT04183387

COMPLETED

The study evaluates anti-inflammatory effects and safety of simvastatin in non-infectious uveitis.

NO

Uveitis

DRUG: Simvastatin 40mg

Incidence of corticosteroid sparing control of ocular inflammation, Incident cases of corticosteroid sparing control of ocular inflammation will be defined using following criteria: 1. ≤0.5+ anterior chamber cells, ≤0.5+ vitreous haze, and no active retinal/choroidal lesions; and 2. ≤10 mg of oral prednisone daily and ≤2 drops of prednisolone acetate 1% (or equivalent) a day; The patient should fullfill both criteria to be classified as having corticosteroid sparing control of ocular inflammation, 8 weeks

Visual acuity, Assessment of visual acuity using the Golovin-Sivtsev table, Baseline, 4 weeks, 8 weeks|Anterior chamber cells, The grades for anterior chamber cells were 0 (<1 cell), 0.5 (1-5 cells), 1 (6-15 cells), 2 (16-25 cells), 3 (26-50 cells), or 4 (>50 cells), Baseline, 4 weeks, 8 weeks|Anterior chamber flare, The grades are the following: 0 (none), 1+ (faint), 2+ (moderate (iris and lens details clear)), 3+ (marked (iris and lens details hazy)), 4+ (intense (fibrin or plastic aqueous), Baseline, 4 weeks, 8 weeks|Vitreous haze, Nussenblatt scale: 0 (no flare), 0.5+ (trace), 1+ (clear optic disc and vessels, hazy nerve fiber layer), 2+ (hazy optic disc and vessels), 3+ (optic disc visible), 4+ (optic disc not visible), Baseline, 4 weeks, 8 weeks|Intraocular pressure, Measured using Maklakov tonometer, Baseline, 4 weeks, 8 weeks|Changes in tear IL-6, Concentrations of IL-6 (pg/ml) in tear samples, Baseline, 8 weeks|Changes in tear IL-8, Concentrations of IL-8 (pg/ml) in tear samples, Baseline, 8 weeks|Changes in tear IL-10, Concentrations of IL-10 (pg/ml) in tear samples, Baseline, 8 weeks|Changes in tear TNFα, Concentrations of TNFα (pg/ml) in tear samples, Baseline, 8 weeks|Changes in tear IFN-γ, Concentrations of IFN-γ (pg/ml) in tear samples, Baseline, 8 weeks|Incidence of corticosteroid sparing control of ocular inflammation, Incident cases of corticosteroid sparing control of ocular inflammation will be defined using following criteria: 1. ≤0.5+ anterior chamber cells, ≤0.5+ vitreous haze, and no active retinal/choroidal lesions; and 2. ≤10 mg of oral prednisone daily and ≤2 drops of prednisolone acetate 1% (or equivalent) a day; The patient should fullfill both criteria to be classified as having corticosteroid sparing control of ocular inflammation, 4 weeks

Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

SMV003

2014-09

2016-01

2016-01

2019-12-03

2019-12-03

Laboratory of Clinical Immunopharmacology, Novosibirsk, 630047, Russian Federation

{ "Simvastatin": [ { "intervention_type": "DRUG", "description": "Simvastatin 40mg", "name": "Simvastatin", "synonyms": [ "Zocor", "Simvastatinum", "MK733", "Simvastatine", "Flolipid", "MK 733", "2,2-dimethylbutyric acid, 8-ester with (4R,6R)-6-(2-((1S,2S,6R,8S,8aR)-1,2,6,7,8,8a-hexahydro-8-hydroxy-2,6-dimethyl-1-naphthyl)ethyl)tetrahydro-4-hydroxy-2H-pyran-2-one", "Simvastatina", "MK-733", "Simvador", "Synvinolin", "Simvastatin" ], "medline_plus_id": "a692030", "generic_names": [ "Simvastatin" ], "nhs_url": "https://www.nhs.uk/medicines/simvastatin", "mesh_id": "D019161", "drugbank_id": "DB00641" } ] }

NCT03922087

No-worry Baby Project

https://clinicaltrials.gov/study/NCT03922087

COMPLETED

The Huizhou mother-infant cohort was set up to investigate the effect of dietary factors and environmental exposures during pregnancy on health consequences of mothers and offsprings in Huizhou, China.

NO

Gestational Diabetes Mellitus in Pregnancy|Gestational Hypertension|Thyroid Disease Pregnancy|Obesity|Anemia in Pregnancy|Complications, Pregnancy|Depression|Obstetric Labor Complications|Asthma|Allergic Disorder|Immune System Diseases|Neurodevelopmental Disorders|Reproductive Disorder

OTHER: No intervention

Number of adverse birth outcomes., Including dystocia,stillbirth, fetal macrosomia and child with birth defect., At delivery.|Children weight changes., Weight is measured in kilograms., At age of 1 month, 3 months, 6months, 1 year, and 3 year.|Children height changes., Height is measured in meters., At age of 1 month, 3 months, 6months, 1 year, and 3 year.|Number of participant with gestational complications., Including gestational hypertension and preeclampsia, and gestational diabetes mellitus., At delivery.

Maternal weight changes(kg)., Assess using electronic weighing machine and body composition analyzer., At 20 weeks of gestation, 28 weeks of gestation, the time before labor and 30 days after delivery.|Number of participant with postnatal depression., Assess using Edinburgh Postnatal Depression Scale (EPDS). The total score of scale is 30 ,and higher score indicates worse status., At 30 days after delivery.

Sun Yat-sen University

Huizhou No.1 Maternal and Child Care Service Cencer

FEMALE

ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

HZT2018

2018-11-20

2022-04-01

2023-09-30

2019-04-19

2023-11-28

School of Public Health of Sun Yat-sen University (North Campus), Guangzhou, Guangdong, 51000, China

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

NCT01774487

Pentoxifylline Therapy in Biliary Atresia

https://clinicaltrials.gov/study/NCT01774487

TERMINATED

The purpose of this study is to determine whether pentoxifylline reduces liver damage in infants with biliary atresia.

YES

Biliary Atresia

DRUG: Pentoxifylline

Number of Participants With Normal Serum Conjugated Bilirubin Levels 12 Weeks After Starting PTX (Pentoxifylline) Therapy, The investigators will track the serum conjugated bilirubin (CB) levels over the course of therapy in patients receiving 90 days of PTX (this laboratory test is drawn as part of routine care). Normal CB is 0.0-0.3 mg/dL, with a higher number of patients meeting this indicating a better outcome., 12 weeks after starting therapy

Number of Participants Achieving Zero or Positive Weight Z-scores 12 Weeks After Starting PTX Therapy, The investigators will track the weight of patients over the course of therapy in patients receiving 90 days of PTX (this is recorded as part of routine clinical care). The weight will then be compared to standards to calculate a z-score. Normal weight Z-score is greater than or equal to 0, with a higher number of patients meeting this indicating a better outcome., 12 weeks after starting therapy|Alanine Amino Transferase (ALT) Levels at 2 Years of Life, The investigators will record the ALT levels at age two years, in patients who had previously been treated with PTX therapy and still have their native liver. Range of normal values: 14-45 U/L, with a higher level indicating a worse outcome., 2 years of age|Spleen Size at 2 Years of Age, The investigators will measure spleen size by ultrasound at 2 years of age, in patients who had received PTX therapy earlier and still have their native liver. Normal spleen size range (10th-90th percentile) at this age is 6.4-8.6 cm, with a value exceeding this range indicating a worse outcome., 2 years of age|Time to Liver Transplant, The investigators will track time to liver transplant. The shorter time to liver transplant indicates a worse outcome., Baseline and up to two years after therapy finishes|Platelet Levels at 2 Years of Life, The investigators will record platelet levels at age two years, in patients who had previously been treated with PTX therapy and still have their native liver. Scale 189-403*10^3 Platelets/μL, with a lower level indicating a worse outcome., 2 years of age

Baylor College of Medicine

ALL

CHILD

PHASE2

OTHER

INTERVENTIONAL

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

H-31387

2013-02-04

2018-02-07

2023-02-20

2013-01-24

2023-10-12

2024-01-11

Texas Childrens Hospital and Baylor College of Medicine, Houston, Texas, 77030, United States

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT01774487/Prot_SAP_000.pdf

{ "Pentoxifylline": [ { "intervention_type": "DRUG", "description": "Pentoxifylline", "name": "Pentoxifylline", "synonyms": [ "Trental", "Torental", "Pentoxifyllinum", "Agapurin", "Pentoxil", "Pentoxifylline", "Oxpentifylline", "Pentoxifilina", "BL 191", "Pentoxifyllin", "BL-191", "BL191" ], "medline_plus_id": "a685027", "generic_names": [ "Pentoxifylline" ], "mesh_id": "D016166", "drugbank_id": "DB00806" } ] }

NCT02993887

Resourcefulness Training and Decentering on Self-Management in Caregivers of Technology Dependent Children

https://clinicaltrials.gov/study/NCT02993887

COMPLETED

The investigators will conduct a randomized clinical trial pilot study to examine the effectiveness of a theoretically based intervention (called ReMind) encompassing two key components: (a) Resourcefulness Training for parent caregivers, and (b) daily mindfulness meditation delivered using a smart phone application (Stop, Breathe & Think™) with an intervention (Mind Only) that consists only of daily mindfulness meditation. Both components of the intervention have been tested separately (but not combined) and both interventions can be self-tailored, which meets the vital need for these caregivers to engage in self-management activities when it is convenient for them. The investigators will test the two arms of the intervention in 30 parents of technology-dependent children, 15 parents in each group. The investigators will collect mixed data at baseline, 3 months and 6 months after subject enrollment to describe changes in proximal and distal outcomes. The investigators aim to: 1. Evaluate the intermediate (3 month) and long-term (6 month) effects of the ReMind and Mind Only interventions on study mediators (HPA Axis Function and stress, cognitive factors, resourcefulness) and determine if there are different effects between ReMind and Mind Only interventions. 2. Evaluate the differences in distal psychological (Mental Health Related Quality of Life, Depressive Cognitions, Depressive Symptoms, Anxiety, Caregiver Burden), physical (Physical Health Related Quality of Life), and cost outcomes between subjects in the ReMind and Mind Only arms over time. 3. Determine the moderating effects of parents social support, demographics (age, gender, family income) and childrens functional status on (a) proximal outcomes and the relationship between (a) the intervention arm and distal outcomes, and (b) HPA Axis Function, stress, cognitive factors and distal outcomes. 4. Evaluate the impact of decentering on the association between the interventions and the proximal and distal outcomes. 5. Explore differences in neurological processing (DMN and TPN) and decentering in proximal and distal outcomes associated with each intervention.

NO

Caregiver|Mindfulness|Mechanical Ventilation Pressure High|Gastrostomy|Chronic Illness

BEHAVIORAL: Resourcefulness Training|BEHAVIORAL: Mindfulness

Change from Baseline Mental & Physical Health Related Quality of Life at 3 Months & 6 Months, Measure using the Patient Reported Outcomes Measurement Information System (PROMIS)-29, Measured at baseline with follow up at 3 months, 6 months

Change from Baseline Appraised Sleep Quality at 3 months and 6 months, Measure using Pittsburgh Sleep Quality Index, Measured at baseline with follow up at 3 months, 6 months|Change from Baseline Positive Health Practices at 3 months and 6 months, Measure using Personal Lifestyle Questionnaire, Measured at baseline with follow up at 3 months, 6 months

University Hospitals Cleveland Medical Center

Case Western Reserve University|The Cleveland Clinic

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

10-16-10

2017-02-20

2019-03-30

2019-03-30

2016-12-15

2019-09-25

University Hospitals Cleveland Medical Center, Cleveland, Ohio, 44106-5065, United States

{ "Resourcefulness Training": [ { "intervention_type": "BEHAVIORAL" } ], "Mindfulness": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT00857987

Effectiveness and Safety of the of Guaifenesin, Doxylamine Succinate and Hydrochloride Etafedrine Syrup in Improvement of Symptoms Resulting From Acute Respiratory Infections.

https://clinicaltrials.gov/study/NCT00857987

UNKNOWN

Evaluate the improvement of the common cold with the use of medication

NO

Upper Airway Infections

DRUG: EMS Expectorant|OTHER: Placebo

- Decrease in nasal secretion - Decrease in sneezing - Reduction of edema of the nasal mucosa - Decreased frequency of cough - Decrease the frequency of dyspnea - Reduction of nasal obstruction, Screening (Day 0); Return to 1 day; Return to 3 days (+/-1); Return of 7 days (+ / -2)

Will be assessed for safety by the incidence of adverse reactions, Screening (Day 0); Return to 1 day; Return to 3 days (+/-1); Return of 7 days (+ / -2)

Azidus Brasil

ALL

CHILD, ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

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

GADEMS0109|GADEMS0109

2010-04

2011-10

2011-12

2009-03-09

2011-01-28

LAL Clinica Pesquisa e Desenvolvimento Ltda, Valinhos, SP, 13270000, Brazil

{ "EMS Expectorant": [ { "intervention_type": "DRUG" } ], "Placebo": [ { "intervention_type": "OTHER" } ] }

NCT01273987

Neobladder Posterior Wall Suspended With Round Ligament of Uterus

https://clinicaltrials.gov/study/NCT01273987

COMPLETED

Objective: to evaluate if the Neobladder posterior wall suspended with round ligament of uterus could improve neobladder empty after radical cystectomy in female patients with bladder cancer compared to present standard neobladder

NO

Female|Bladder Cancer|Radical Cystectomy|Neobladder|Posterior Wall Suspended With Round Ligament of Uterus

PROCEDURE: rONB

postvoiding residual urine (PVP), number of patients with postvoiding residual urine (PVP) more than 100ml, 2 years after operation|clean intermittent catheterization(CIC), number of patients required clean intermittent catheterization(CIC), 2 years after operation

rate of complication, number of patients with any complication, through study completion, an average of 2 years|urodynamic profile, urodynamic parameter including peak flow rate, functional urethral length ...etc, 12 months afer operation|rate of continence of neobladder, number of patients with continence at daytime and nighttime, 12 months after operation

Zhiwen Chen

FEMALE

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

Neobladder-01

2011-01-01

2019-11-08

2020-03-20

2011-01-11

2020-03-31

Urology Institute of PLA, Southwest Hospital, Chongqing, 400038, China

{ "rONB": [ { "intervention_type": "PROCEDURE" } ] }

NCT03685487

Decolonization of Patients Carrying S. Aureus Before Cardiac Surgery: Study of the Risk Factors Associated With Failure

https://clinicaltrials.gov/study/NCT03685487

STAdécol

COMPLETED

Staphylococcus aureus nasal carriage is a well-known risk factor for S. aureus surgical site infections (SSI). According to a recent study demonstrating 60% reduction risk of SSI due this bacterium after patients screening and decolonization, recent French and WHO guidelines recommend in cardiac surgery the decolonization of nasal S. aureus carriers before surgery. In practice the decolonization procedures are not well-defined according notably to the duration and time of delivery before surgery and doses of topical antimicrobial drugs. The aim of the proposed study is to investigate the factors associated with failures of S. aureus decolonization: carriage state, compliance with treatment, S. aureus capacity of internalization in nasal epithelial cells, resistance to antimicrobial drugs used. This study will allow (i) to measure the frequency of patients with residual S. aureus carriage just before surgery, whatever they have been decolonized or not, (ii) to characterize the S. aureus nasal carriage state of patients before surgery, and (iii) to investigate the adding value of mupirocin dosage in the nose and urines of decolonized patients as a marker of compliance and efficacy of the decolonization process.

NO

Staphylococcus Aureus

PROCEDURE: decolonization|OTHER: compliance questionnaire

number of participants with failure of decolonization of nasal carriers of S. aureus, These patients were screened positive for S. aureus in nasal swab culture collected during the preoperative consultation of cardiac surgery, who received a decolonization prescription and who are again detected positive in culture for S. aureus on the nasal collection performed on admission to the surgery department (just before surgery)., just before surgery

Prevalence of nasal carriage of S. aureus just prior to cardiac surgery in all patients, before surgery|Prevalence of nasal carriage of S. aureus 3 months after cardiac surgery in all patients, 3 months|Correlation between nasal dosing of mupirocin and compliance, 3 months|Correlation between mupirocin urine metabolite assay associated with mupirocin nasal dosing and decolonization efficacy (failure or not)., 3 months

Centre Hospitalier Universitaire de Saint Etienne

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

18CH049|2018-001505-90

2019-02-12

2020-02-26

2020-03-10

2018-09-26

2022-01-11

Chu Saint-Etienne, Saint-Etienne, 42055, France

{ "decolonization": [ { "intervention_type": "PROCEDURE" } ], "compliance questionnaire": [ { "intervention_type": "OTHER" } ] }

NCT03782987

A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 730357 in the Blood

https://clinicaltrials.gov/study/NCT03782987

COMPLETED

The main objective of this trial is to investigate the relative bioavailability of BI 730357 in plasma when given as oral single dose together with multiple oral doses of itraconazole (Test, T) as compared to when given alone as oral single dose (Reference, R)

YES

Healthy

DRUG: BI 730357|DRUG: Itraconazole

Area Under the Concentration-time Curve of the BI 730357 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz), AUC0-tz, area under the concentration-time curve of the BI 730357 in plasma over the time interval from 0 to the last quantifiable data point is presented., Pharmacokinetic samples were taken within 3 hours (h) before administration of BI 730357 and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 h in both periods and additionally at 215 and 263 h only for period 2.|Maximum Measured Concentration of the BI 730357 in Plasma (Cmax), Cmax, maximum measured concentration of the BI 730357 in plasma is presented here., Pharmacokinetic samples were taken within 3 hours (h) before administration of BI 730357 and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 h in both periods and additionally at 215 and 263 h only for period 2.

Area Under the Concentration-time Curve of the BI 730357 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞), AUC0-∞, area under the concentration-time curve of the BI 730357 in plasma over the time interval from 0 extrapolated to infinity is presented here., Pharmacokinetic samples were taken within 3 hours (h) before administration of BI 730357 and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, 71, 119 and 167 h in both periods and additionally at 215 and 263 h only for period 2.

Boehringer Ingelheim

MALE

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

1407-0014|2018-003495-13

2019-01-10

2019-03-11

2019-03-11

2018-12-20

2023-07-12

2023-07-12

Humanpharmakologisches Zentrum Biberach, Biberach, 88397, Germany

Study Protocol, https://cdn.clinicaltrials.gov/large-docs/87/NCT03782987/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT03782987/SAP_001.pdf

{ "BI 730357": [ { "intervention_type": "DRUG" } ], "Itraconazole": [ { "intervention_type": "DRUG", "description": "Itraconazole", "name": "Itraconazole", "synonyms": [ "3H-1,2,4-TRIAZOL-3-ONE, 4-(4-(4-(4-((2-(2,4-DICHLOROPHENYL)-2-(1H-1,2,4-TRIAZOL-1-YLMETHYL)-1,3-DIOXOLAN-4-YL)METHOXY)PHENYL)-1-PIPERAZINYL)PHENYL)-2,4-DIHYDRO-2-(1-METHYLPROPYL)-", "Orungal", "R 51211", "Sporanox", "R51211", "Itraconazol", "(\u00b1)-1-SEC-BUTYL-4-(P-(4-(P-(((2R*,4S*)-2-(2,4-DICHLOROPHENYL)-2-(1H-1,2,4-TRIAZOL-1-YLMETHYL)-1,3-DIOXOLAN-4-YL)METHOXY)PHENYL)-1-PIPERAZINYL)PHENYL)-.DELTA.(SUP 2)-1,2,4-TRIAZOLIN-5-ONE", "Oriconazole", "Onmel", "Itraconazole", "ITRACONAZOLE COMPONENT OF SUBA-ITRACONAZOLE", "R-51211", "Itraconazolum" ], "medline_plus_id": "a692049", "generic_names": [ "Itraconazole" ], "mesh_id": "D065692", "drugbank_id": "DB01167" } ] }

NCT02931487

Restoring Emotion Regulation Networks in Depression Vulnerability

https://clinicaltrials.gov/study/NCT02931487

COMPLETED

Selective biases in attention can be modified by a simple computerized technique: The Attention Bias Modification Task (ABM) pioneered by MacLeod et al. Cognitive biases may be one reason depression recurs, and altering these biases should reduce risk of recurrence. Recently, evidence has supported this hypothesis . The mechanisms by which ABM works are not well understood. More research is needed to explore how altering an implicit attentional bias can lead to changes in subjective mood. One possible explanation is that positive attentional biases are an important component of explicit methods of emotion regulation. The ability to effectively regulate ones emotions is a fundamental component of mental health and this ability is impaired in depression. It has also been shown that recovered depressed people spontaneously show a more dysfunctional pattern of emotion regulation as compared to never depressed controls. Supporting this, growing evidence implicates dysregulation of a medial/orbitofrontal circuit in mood disorders. This circuit includes the orbitofrontal cortex and anterior cingulate cortex, the ventral striatum, the ventral pallidum and medial thalamus. Components of this circuit are reciprocally connected with the amygdala, which is implicated in emotional processing in the healthy brain and dysregulated in depression. Negative emotion processing biases depend on both enhanced bottom-up responses to emotionally salient stimuli and reduces top-down cognitive control mechanisms, required to suppress responses to emotionally salient but task irrelevant information. Cognitive reappraisal and distancing are common strategies to down- or upregulate emotional responses. Reappraisal is an emotion regulation strategy that involves reinterpretation and changing the way one thinks about an event or stimulus with the goal of changing its affective impact. Distancing is a type of reappraisal that involves creating mental space between oneself and the emotional event in order to see things from a different, less self-focused perspective. It has been shown that distancing is a strategy that people can improve at over time compared to reinterpretation. The neural systems which support the explicit regulation of emotion have previously been characterized and include both lateral- and prefrontal cortex. This frontal activity is predicted to downregulate limbic circuitry involving the amygdala during passive viewing of emotional salient stimuli.

NO

Major Depression

BEHAVIORAL: Attentional Bias Modification|BEHAVIORAL: Sham Comparator

BOLD response in prefrontal cortical regions, Stronger fMRI BOLD response in prefrontal cortical regions in ABMT compared to neutral AMB placebo condition., Two weeks after after ABM-training

BOLD response within the amygdala, Lower ABM fMRI BOLD response within the amygdala in ABMT compared to neutral ABM placebo condition., Two weeks after ABM-training|DTI, Increased neural integrity as measured by fractional anisotropy values in the uncinate fasciculi (UF) in the active AMBT compared to neutral ABM placebo condition., Two weeks after ABM-training|RSFC, Increased integrity within the attentional networks at rest as measured by independent component analysis (ICA) in ABMT compared to neutral ABM training., Two weeks after ABM-training|5-HTTLPR + A>G polymorphic variation divided by the triallelic functional high expressive versus low expressive genotype will moderate the impact from ABMT as measured by whole brain BOLD responses., The low expressive variant will be associated with more frontal BOLD activation and lower amygdala activation after ABMT, Two weeks after ABM-training|BDNF, Brain Derived Neurotropic Factor (BDNF) val66met polymorphic variation linked to Brain Derived Neurotropic Factor (BDNF) variation will differentiate between ABMT and neutral AMB placebo as measured by fMRI whole brain BOLD responses., Two week after ABM-training|Serotonergic cumulative genetic score and fMRI, A serotonergic cumulative Genetic score, including (5-HHTLPR, HTR1A 8rs6295) and HTR 2A (rs 6311) polymorphisms will moderate the effects of ABM on fMRI BOLD signal compared to a neutral placebo condition., Two weeks after ABM-training|Serotonergic cumulative genetic score and morphompetry, A serotonergic cumulative Genetic score, including (5-HHTLPR, HTR1A 8rs6295) and HTR 2A (rs 6311) polymorphisms will moderate the effects of ABM on structural MRI as measured by total grey matter volume compared to a neutral placebo condition., Two weeks after ABM-training|Serotonergic cumulative genetic score and fMRI and DTI, A serotonergic cumulative Genetic score, including (5-HHTLPR, HTR1A 8rs6295) and HTR 2A (rs 6311) polymorphisms will moderate the effects of ABM on DTI MRI as measured by fractional anisotropy compared to a neutral placebo condition., Two weeks after ABM-training

University of Oslo

Oslo University Hospital|University of Oxford

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

HSØ-2015052

2015-05

2016-12

2016-12

2016-10-13

2019-04-30

University of Oslo, Department of Psychology, Oslo, 0317, Norway

{ "Attentional Bias Modification": [ { "intervention_type": "BEHAVIORAL" } ], "Sham Comparator": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT05809687

Phase 3 Trial to Evaluate the Efficacy and Safety of DKP21102_B Added on to DKP21102_A Compared With DKP21102_A

https://clinicaltrials.gov/study/NCT05809687

NOT_YET_RECRUITING

Phase 3 study to evaluate the efficacy and safety of DKP21102_B Added on to DKP21102_A Compared with DKP21102_A

NO

Dyslipidemias

DRUG: DKP21102_C|DRUG: DKP21102_B|DRUG: DKP21102_A

Percent change (%) of non-HDL-C from baseline, non-HDL-C, from baseline at 12weeks

Dongkwang Pharm. Co., Ltd.

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

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

DKP21102_301

2024-07-01

2026-12-01

2027-12-01

2023-04-12

2024-02-20

{ "DKP21102_C": [ { "intervention_type": "DRUG" } ], "DKP21102_B": [ { "intervention_type": "DRUG" } ], "DKP21102_A": [ { "intervention_type": "DRUG" } ] }

NCT01832987

Pharmacokinetic Parameters of Co-trimoxazole

https://clinicaltrials.gov/study/NCT01832987

COMPLETED

Rationale: Treatment of multidrug or extensively drug resistant tuberculosis (MDR/XDR-TB) is a real challenge as failure in response to treatment and serious side-effects are frequently encountered. New, more effective drugs with less side effects are therefore urgently needed to solve this problem. Although several new drugs against TB are in the pipeline, physicians currently have limited treatment options for treatment of complicated MDR/XDR-TB cases. Therefore, drugs developed and labeled for other infectious diseases are evaluated for TB. Co-trimoxazole consists of sulfamethoxazole and trimethoprim. Sulfamethoxazole could be effective in the treatment of tuberculosis as shown by Forgacs et al. and Huang et al. Furthermore, with dried blood spot (DBS) analysis, the exposure to co-trimoxazole could be analyzed with only some blood drops withdrawn with a finger prick on paper. This paper is suitable for storage, transportation and subsequently analysis without additional cooling or storage requirements. Objective: The main objective of this prospective clinical trial is to evaluate pharmacokinetics of 960 mg co-trimoxazole in TB patients. This clinical trial will provide important information on PK of co-trimoxazole in TB patients for future studies. The second objective is to calculate the T>MIC and AUC0-24h/Minimal inhibitory concentration (MIC) ratio as efficacy predicting parameter. Furthermore, the analysis of dried blood spots will be clinically validated by comparing results of blood samples withdrawn from venous blood versus withdrawn by finger prick and transferred to filter paper. Retrospectively, data from this study can be used for limited sampling strategies for co-trimoxazole based on a pharmacokinetic population model constructed from the full PK curves of the patients. Study design: A prospective pharmacokinetic study. Study population: 12 TB patients. Intervention: on 4 to 6 days, 960 mg co-trimoxazole daily will be added to the normal treatment regimen. Main study parameters/endpoints: The pharmacokinetic parameters (Vd, Cl, AUC, etc) of co-trimoxazole are the primary endpoints of the study. The T>MIC and AUC0-24h/Minimal inhibitory concentration (MIC) ratio are most likely the best predictive parameters for efficacy of co-trimoxazole treatment and will be calculated for a range of M tuberculosis isolates.

NO

Tuberculosis

DRUG: co-trimoxazole

AUC, Measuring the AUC over 24 hours of sulfamethoxazole, one out of two compounds of co-trimoxazole after obtaining steady state (960 mg co-trimoxazole)., 4th, 5th or 6th day

Determination of the AUC/MIC and T>MIC, Determination of the area under the curve divided by the mean inhibitory concentration and the time above MIC., 4th, 5th or 6th day|Validating DBS analysis, Validating the analysis of dried blood spots for therapeutic drug monitoring by comparing the concentration measured in venous blood with the concentration measured using the dried blood spot method., 4th, 5th or 6th day

Population pharmacokinetic model and limited sampling strategies, Developing a population pharmacokinetic model to predict pharmacokinetic parameters of sulfamethoxazole. With this population pharmacokinetic model, a limited sampling strategy will be developed., 4th, 5th or 6th day

University Medical Center Groningen

ALL

ADULT

PHASE2

OTHER

INTERVENTIONAL

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

SXT8469

2013-10

2014-08

2014-08

2013-04-16

2014-09-16

UMCG - Tuberculosis Center, Groningen, Netherlands

{ "co-trimoxazole": [ { "intervention_type": "DRUG" } ] }

NCT05539287

Clinical Study Evaluating the Safety of Lactobacillus Probiotic in Children With Drug Resistant Epilepsy

https://clinicaltrials.gov/study/NCT05539287

RECRUITING

Animal and human studies have brought up evidence supporting Gut microbial disbalance, namely dysbiosis, as a causative factor of epilepsy, especially the refractory form. thus, probiotics might constitute a safe, low-cost, and effective supplementary therapy in patients with DRE. The Lactobacillus population is probiotic bacteria that have a beneficial role in epilepsy. Lactobacillus can influence brain function through the modulation of GABA, as shown in rodent models. Moreover, it has been demonstrated in animal models of epilepsy and in human epileptic patients that probiotic treatment aimed at restoring gut microbiota equilibrium has beneficial effects on epileptic symptoms by increasing GABA in animals and the levels of Bifidobacteria and Lactobacillus in humans.

NO

Drug Resistant Epilepsy

DRUG: Lactobacillus-Based Capsule

effectivness of Lactobacillus probiotics for controlling epileptic seizures in children with drug resistant epilepsy, effectivness can be defined as more than 50% reduction in number of seizures., 6 months

1. the change in the concentration of measured biological parameters (NLRP3, and GAD-Ab), Before and 6 months after intervention, 5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture between 8 am and 11 am. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of : * Serum NLRP3 inflammasome level. * Serum glutamic acid decarboxylase antibody (GAD-Ab)., 6 months

Tanta University

ALL

CHILD, ADULT

PHASE2

OTHER

INTERVENTIONAL

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

Lactobacillus in DRE.

2022-09-25

2024-08

2025-01

2022-09-14

2022-10-10

Amira, Tanta, Egypt

{ "Lactobacillus-Based Capsule": [ { "intervention_type": "DRUG" } ] }

NCT01249287

FMRI in Monitoring Intracerebral Stem Cell Implantation for Chronic Stroke Patients

https://clinicaltrials.gov/study/NCT01249287

UNKNOWN

A growing number of studies highlight the potential of stem cell transplantation as a novel therapeutic approach for stroke in animal model. But the stem cell therapy for chronic stroke patients has not been well investigated yet. In this study, the investigators will test the hypothesis that intracerebral peripheral blood hematopoietic stem cell (CD34+) (PBSC) transplantation induces neuroplasticity in chronic stroke patients. The remyelination of corticospinal tract in the lesion side, focal increased perfusion and increased cortical activity in the peri-infarcted area will be monitored by the functional MRI after stem cell therapy. The investigators study is aimed to find the potential mechanisms of the functional recovery after stem cell implantation. The investigators also hope to find image surrogate markers for prediction of patient outcome. The possible surrogate markers will be helpful in improving the treatment procedure and patient selection.

NO

Stroke

China Medical University Hospital

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

DMR98-IRB-031

2009-04

2010-11-29

2010-11-29

{}

NCT01081587

Preventing Malnutrition and Restoring Nutritional Status in Hospitalized Children

https://clinicaltrials.gov/study/NCT01081587

PREDIRE

COMPLETED

This cluster-randomized trial will evaluate the impact of a multifaceted intervention (including electronic medical alerts) coordinated by a Nutritional Support Team, on adherence to recommended practices for care of starved children, among health personnel of a large university hospital. A key component of the study is to assess whether improved adherence to guidelines leads to a reduction in rates of complications.

NO

Nutrition Disorders

PROCEDURE: Access to a Computerized Clinical Decision Support System (CCDDS)|BEHAVIORAL: Education of Healthcare workers|OTHER: Local assistance by a dietician

Adherence to recommended practices (including weigh in, physiotherapy, nutrition survey and monitoring), At least 2 days depending on the hospitalisation time

Incidence of complications, At least 2 days depending on the hospitalisation time|Nutritional status evolution, At least 2 days depending on the hospitalisation time|Mean length and cost of stay, At least 2 days depending on the hospitalisation time|Appropriate call-in Nutritional Support Team, At least 2 days depending on the hospitalisation time

Hospices Civils de Lyon

ALL

CHILD, ADULT

OTHER

INTERVENTIONAL

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

2008.522/23

2009-10

2011-10

2011-10

2010-03-05

2013-05-15

Hospices Civils de Lyon (HCL) - Hôpital Femme-Mère-Enfant, Bron, 69677, France

{ "Access to a Computerized Clinical Decision Support System (CCDDS)": [ { "intervention_type": "PROCEDURE" } ], "Education of Healthcare workers": [ { "intervention_type": "BEHAVIORAL" } ], "Local assistance by a dietician": [ { "intervention_type": "OTHER" } ] }

NCT00647387

Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study

https://clinicaltrials.gov/study/NCT00647387

VPA

ACTIVE_NOT_RECRUITING

The AMPLATZER Muscular VSD Occluder was approved by the US Food and Drug Administration (FDA) in September, 2007. This study is designed to further evaluate the safety and effectiveness in subjects implanted with the AMPLATZER Muscular VSD Occluder.

NO

Ventricular Septal Defects

DEVICE: Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)

The primary safety objective is to evaluate the proportion of subjects experiencing a major adverse event within 12 months of the procedure. Subjects will be followed for 5 years post implant., 12 months

Abbott Medical Devices

ALL

CHILD, ADULT, OLDER_ADULT

INDUSTRY

INTERVENTIONAL

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

AGA-016

2008-03

2025-08

2025-08

2008-03-31

2024-02-16

St. Joseph Hospital and Medical Center, Phoenix, Arizona, 85013, United States|Phoenix Childrens Hospital, Phoenix, Arizona, 85016, United States|Childrens Hospital Los Angeles (USC), Los Angeles, California, 90027, United States|Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States|Ronald Reagan UCLA Medical Center, Los Angeles, California, 90095, United States|Valley Childrens Hospital, Madera, California, 93638, United States|Stanford University Medical Center, Palo Alto, California, 94304, United States|Rady Childrens Hospital, San Diego, California, 92123, United States|Childrens Hospital of Colorado, Aurora, Colorado, 80045, United States|Yale New Haven Hospital, New Haven, Connecticut, 06510-3202, United States|Nemours/Alfred I. duPont Hospital for Children, Wilmington, Delaware, 19803, United States|Childrens National Medical Center, Washington, District of Columbia, 20010, United States|Joe DiMaggio Childrens Hospital, Hollywood, Florida, 33021, United States|Jackson Memorial Hospital, Miami, Florida, 33136, United States|Arnold Palmer Hospital, Orlando, Florida, 32806, United States|All Childrens Hospital, Saint Petersburg, Florida, 33701, United States|Childrens Healthcare of Atlanta, Atlanta, Georgia, 30322, United States|Augusta University, Augusta, Georgia, 30912, United States|University of Chicago Medical Center, Chicago, Illinois, 60637, United States|Advocate Christ Medical Center, Oak Lawn, Illinois, 60453, United States|Riley Hospital for Children, Indianapolis, Indiana, 46202, United States|University of Iowa Hospitals & Clinics, Iowa City, Iowa, 52242, United States|University of Kentucky, Lexington, Kentucky, 40536, United States|University of Maryland Medical Center, Baltimore, Maryland, 21201, United States|Childrens Hospital of Michigan, Detroit, Michigan, 48201, United States|Sparrow Clinical Research Institute, Lansing, Michigan, 48912, United States|Munson Medical Center, Traverse City, Michigan, 49684, United States|Childrens Hospitals and Clinics of Minnesota, Minneapolis, Minnesota, 55404, United States|University of Minnesota Medical Center Fairview, Minneapolis, Minnesota, 55455, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States|University of Missouri-Kansas City School of Medicine, Kansas City, Missouri, 64108, United States|St. Louis Childrens Hospital, Saint Louis, Missouri, 63110, United States|Sunrise Hospital, Las Vegas, Nevada, 89109, United States|Deborah Heart & Lung Center, Browns Mills, New Jersey, 08015, United States|Childrens Hospital of New York-Presbyterian, New York, New York, 10032, United States|University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, United States|Duke University Medical Center, Durham, North Carolina, 27710, United States|The Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States|Nationwide Childrens Hospital, Columbus, Ohio, 43205, United States|Medical University of South Carolina, Charleston, South Carolina, 29425, United States|Methodist LeBonheur Healthcare, Memphis, Tennessee, 38104, United States|University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, 75235, United States|Texas Childrens Hospital, Houston, Texas, 77030, United States|University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States|University of Virginia Medical Center, Charlottesville, Virginia, 22908, United States|Seattle Childrens Hospital, Seattle, Washington, 98105, United States|Childrens Hospital of Wisconsin, Milwaukee, Wisconsin, 53226, United States|BC Childrens Hospital, Vancouver, Bristish Columbia, V6H3N1, Canada|The Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada|Hopital Sainte-Justine, Montreal, Quebec, Canada

{ "Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)": [ { "intervention_type": "DEVICE" } ] }

NCT02778087

Mirror Therapy After Stroke: A Dosing Study

https://clinicaltrials.gov/study/NCT02778087

TERMINATED

It has been suggested that augmenting repetitive task practice with the use of box (mirror) therapy (BT) can enhance the benefits of task practice and may provide stroke survivors an opportunity to engage in self-directed practice outside of normally scheduled therapy sessions. However, the dosage of BT to be used in clinical practice is unclear. In order for practitioners to begin integrating BT into clinical practice situations more information is needed to determine what defines a therapeutic dose. The aim of this study is to differentiate between two dosages of self-directed BT added to treatment as usual for decreasing arm and hand motor impairments, improving activity level, and increasing self-directed participation after stroke. Forty-five subjects from the Stroke Rehabilitation Unit at Helen Hayes Hospital (HHH) will be randomly assigned into three groups: treatment as usual plus 30 minute dosage of self-directed BT 5x/week; treatment as usual plus 60 minute dosage of self-directed BT 5x/week; treatment as usual plus 30 minutes of self-directed sham BT 5x/week.

NO

Stroke

BEHAVIORAL: Mirror Box Therapy|BEHAVIORAL: Sham Mirror Box Therapy

Score on Action Research Arm Test:, This test examines hand and arm motor function. It consists of 19 movement tasks divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale, ranging from 3 (performs test normally) to 0 (can perform no part of test). Totaled scores range from 0-57 with higher scores indicating higher functioning. Normative data for stroke has been published for this tool (Beebe & Lang, 2009; van der Lee et al., 2001). This tool has been found to be a valid measure (Platz et al., 2005; van der Lee et al., 2001). This test has excellent test-retest reliability (Platz et al., 2005), as well as inter-rater reliability (Nijland et al., 2010). Minimally clinically important difference (MCID) for this test has been established for both acute (Lang et al., 2008) and chronic stroke survivors (van der Lee et al., 2001)., pre and post intervention up to 12 months

Score on Stroke Impact Scale, This is a questionnaire including questions regarding whether the stroke has resulted in physical problems, problems with memory and thinking, changes in mood and emotions, problems with communication, daily living skills, mobility, and hand function. Normative data has been published for stroke survivors (Duncan et al., 2002). Several authors have established the validity of this tool (Doyle et al., 2007; Duncan et al., 2002; Huang et al., 2010; Kwon et al., 2006). This measure has adequate to excellent test-retest reliability depending on the domain (Duncan et al., 1999), as well as intra-rater reliability (Carod-Artal et al., 2009)., pre and post intervention up to 12 months|Score on Functional Independence Measure, This provides a measurement of a subjects disability based on the International Classification of Impairment, Disabilities and Handicaps, and it indicates how much assistance the individual will need to carry out common basic activities of daily living. It contains 18 items that are rated on a seven point ordinal scale from total assistance to complete independence, and totaled scores range from a low of 18 to a high of 126, with higher scores indicating higher functioning. Normative data has been published for stroke survivors (Inouye et al., 2001). The validity of this measure has established (Inouye et al., 2001; Denti et al., 2008; Hsueh et al., 2002). This test has been found to have excellent test-retest reliability (Pollak et al., 1996; Hobart et al., 2001)., pre and post intervention up to 12 months|Score on Fugl-Meyer Assessment of Motor Recovery after Stroke (arm/hand section), This test examines a variety of reaching patterns, wrist and hand function, quality of movement, sensation, and reflexes. Items are scored on a 3-point ordinal scale from 0 (cannot perform) to 2 (performs fully). The domains assessed include: Motor function (UE maximum score = 66), Sensory function (UE maximum score = 12), and Joint pain (maximum score = 24). This tool is one of the most widely used quantitative measures of motor impairment after stroke (Gladstone et al., 2002). Multiple authors have documented the validity of this tool (Malouin et al., 1994; Mao et al., 2002; Shelton et al., 2001). It has excellent inter- and intra-rater reliability (Duncan, 1983). It has been found to be a strong predictor of motor function (Duncan, et al., 1992)., pre and post intervention up to 12 months

Columbia University

Helen Hayes Hospital

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

AAAQ2004

2017-01

2018-02-13

2018-02-13

2016-05-19

2018-02-14

Helen Hayes Hospital (Stroke Unit), West Haverstraw, New York, 10993, United States

{ "Mirror Box Therapy": [ { "intervention_type": "BEHAVIORAL" } ], "Sham Mirror Box Therapy": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT06304987

Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and PCSK9 Inhibitor for pMMR/MSS Locally Advanced Mid-low Rectal Cancer

https://clinicaltrials.gov/study/NCT06304987

NOT_YET_RECRUITING

This is a multicenter, prospective, randomized controlled study to evaluate the effectiveness and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and PCSK9 inhibitor in the treatment of patients with pMMR/MSS locally advanced middle and low rectal cancer.

NO

Locally Advanced Rectal Cancer

COMBINATION_PRODUCT: Long-course chemoradiation and PD-1 inhibitor, with PCSK9 inhibitor|COMBINATION_PRODUCT: Long-course chemoradiation and PD-1 inhibitor, without PCSK9 inhibitor

CR, complete response rate=(number of pathological complete responses + number of clinical complete responses)/total number of patients, pCR :within 10 days after surgery;cCR :12-13 weeks after radiotherapy ends|AE rate, Adverse event rate, during treatment

NAR score, Neoadjuvant rectal（NAR）score：It is based on the scoring criteria of preoperative treatment, within 10 days after surgery|OPR, organ preservation rate, immediately after surgery|ORR, objective response rate, within 10 days after surgery|immune-related adverse event rate, adverse event rate that is deemed to be associated with PD-1 inhibition, up to 30th day after surgery

Beijing Friendship Hospital

Peking Union Medical College Hospital|Peking University Cancer Hospital & Institute|Changhai Hospital

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

BFH-niCRT-05

2024-04

2026-04

2026-05

2024-03-12

2024-03-19

Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, 100050, China|Beijing Friendship Hospital, Beijing, Beijing, 100050, China

{ "Long-course chemoradiation and PD-1 inhibitor, with PCSK9 inhibitor": [ { "intervention_type": "COMBINATION_PRODUCT" } ], "Long-course chemoradiation and PD-1 inhibitor, without PCSK9 inhibitor": [ { "intervention_type": "COMBINATION_PRODUCT" } ] }

NCT03283787

Comparing Concomitant Use of ACell MicroMatrix® and ACell Cytal™ to Standard of Care in Stage 3 or 4 Pressure Injuries

https://clinicaltrials.gov/study/NCT03283787

COMPLETED

The purpose of this study is to evaluate incidence of complete epithelialization in stage 3 & 4 pressure ulcers using ACell products.

YES

Pressure Ulcers Stage III|Pressure Ulcer, Stage IV|Pressure Ulcer

DEVICE: MicroMatrix® and Cytal™ Wound Matrix 2-Layer|DEVICE: MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT|DEVICE: Negative Pressure Wound Therapy

Incidence of Complete Epithelialization, Number of participant wounds with complete epithelialization by 12 weeks. Complete wound closure (epithelialization) determination based on PI assessment., 12 weeks

Time to Complete Wound Epithelization, Time to complete wound epithelization between groups., 12 weeks|Rate of Wound Epithelization, Rate of wound epithelization between groups, 12 weeks

Integra LifeSciences Corporation

St Vincents Hospital

ALL

ADULT, OLDER_ADULT

INDUSTRY

INTERVENTIONAL

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

CA2016-001

2017-04-01

2019-09-25

2019-12-23

2017-09-14

2020-11-16

2021-04-20

Saint Vincents Medical Center, Jacksonville, Florida, 32204, United States

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT03283787/Prot_SAP_000.pdf

{ "MicroMatrix\u00ae and Cytal\u2122 Wound Matrix 2-Layer": [ { "intervention_type": "DEVICE" } ], "MicroMatrix\u00ae and Cytal\u2122 Wound Matrix 2-Layer plus NPWT": [ { "intervention_type": "DEVICE" } ], "Negative Pressure Wound Therapy": [ { "intervention_type": "DEVICE" } ] }

NCT00937287

Human Papilloma Virus (HPV) Vaccination Among Rural African American Primary Caregivers and Daughters

https://clinicaltrials.gov/study/NCT00937287

COMPLETED

African American women living in the rural South are twice as likely as Caucasian women to develop cervical cancer and die of invasive cervical cancer at a higher rate than any other racial/ethnic group in the US (1). Reasons for low HPV vaccination rates among rural African Americans are not well understood. HPV vaccination compliance is likely influenced by barriers to health care access, misinformation regarding vaccinations, religious beliefs related to sexual health and behaviors, and mistrust of the medical community (2, 3). Because the vaccination of minors requires primary caregiver consent, vaccination commitment and compliance is strongly influenced by family beliefs and communication regarding health and sexuality. To date, little research has examined the cultural, familial, and intrapersonal influences on HPV vaccination compliance among rural African American women. This study will address these gaps in the literature and provide data needed to develop effective interventions and health promotion materials to encourage HPV vaccination among rural African American women. From a pool of approximately 800 families who are participating in ongoing longitudinal research through the Center for Family Research at the University of Georgia, the investigators will recruit 200 rural female African American youth aged 13-17 who have not received the HPV vaccine and their primary caregivers (n=200) into an observational, prospective study on vaccination commitment and compliance. The investigators hypotheses are as follows: 1. Sociocultural factors that rural African Americans experience, including discrimination, previous health care experience, religious beliefs, and community norms regarding HPV vaccination and adolescent sexual behavior, will forecast primary caregivers HPV vaccination commitment and compliance for their daughters. The investigators also predict that primary caregivers HPV-related knowledge and attitudes will mediate this association. 2. Sociocultural factors will influence sexual health-related family communication and interaction, primary caregivers and youths HPV-related attitudes, and HPV vaccination commitment and compliance. 3. Primary caregivers attitudes, youths attitudes, and family health communication will contribute to youths and caregivers vaccination commitment and compliance. 4. Youths sexual behavior will influence their attitudes, family health communication, and vaccination commitment and compliance.

NO

Human Papillomavirus

OTHER: There is no intervention in this study.

HPV vaccination compliance, 1 year

University of Georgia

FEMALE

CHILD

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

MISP 36701

2009-07

2011-04

2012-07

2009-07-10

2013-08-14

The Center for Family Research, Athens, Georgia, 30602, United States

{ "There is no intervention in this study.": [ { "intervention_type": "OTHER" } ] }

NCT01669187

The Effects of Pre-operative Physical Therapy Education

https://clinicaltrials.gov/study/NCT01669187

WITHDRAWN

It is expected that patients who receive physical therapy before surgery will have greater range of motion (ROM), strength, function, satisfaction, and less swelling, pain, and anxiety following surgery compared to those in the control group.

NO

Breast Cancer

OTHER: Education brochure|OTHER: Live education and exercise instruction

Change in score for Shoulder Pain and Disability Index (SPADI), Functional outcome measure questionnaire, Before sugery (range 0-4 weeks before surgery), 2 weeks post operatively and 6 weeks post-operatively

Change in Shoulder range of motion with goniometer, Pre-operatively (0-4 weeks pre-operatively), 2 and 6 weeks post-operatively

Change in other physical therapy test and measures, 6 minute walk test; presence of cording; number of patient reported medical complications; shoulder strength measured by a dynamometer; Arm lymphedema measured by volumeter; Anxiety, general functional abilities, and QOL will be measured by the Functional Assessment of Cancer Therapy- Breast Cancer (FACT-B); Patient satisfaction will be measured using a 5 point Likert Scale., Once pre-operatively (0-4 weeks before surgery), 2 and 6 weeks after surgery

Oakland University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

OU-4824

2011-12

2012-12

2012-12

2012-08-20

2014-04-10

St-Marys of Michigan, Saginaw, Michigan, 48601, United States|St. Marys of Michigan, Saginaw, Michigan, 48601, United States

{ "Education brochure": [ { "intervention_type": "OTHER" } ], "Live education and exercise instruction": [ { "intervention_type": "OTHER" } ] }

NCT05892887

Analgesic Efficacy of Different Volumes in Erector Spinae Plane Block in Single Level Lumbar Spine Fixation

https://clinicaltrials.gov/study/NCT05892887

COMPLETED

The analgesic efficacy of different volumes in ESPB patients undergoing single-level lumbar spine fixation

NO

Analgesia

DRUG: Bupivacaine 0.25% Injectable Solution

Total morphine consumption, Patients were allowed to receive incremental doses of morphine 3mg intravenously if numerical rating scale pain score will be ≥ then the total amount of morphine will be recorded, First 24 hours postoperatively

Numerical rating scale, Postoperative pain using numerical rating scale (NRS) will be measured at post-anesthesia care unit, from 0 to 10, with 0 representing no pain and 10 representing maximum intolerable pain, Up to 48 hours postoperatively|Time to the first rescue analgesic, If numerical rating scale >4 was observed, rescue analgesia (morphine 3 mg IV) was administered, Up to 24 hours postoperatively|Postoperative complications, postoperative nausea and vomiting (PONV), hypotension (mean arterial pressure < 20% of baseline readings and was managed by ephedrine 5 mg IV and/or normal saline IVI), bradycardia (heart rate < 60 beats/min and was managed by atropine 0.6 mg IV)., Up to 24 hours postoperatively|5-point scale, The degree of patient satisfaction was assessed on a 5-point scale: (0= extremely dissatisfied, 1= unsatisfied, 2= neither satisfied nor unsatisfied, 3= satisfied), and 4= extremely satisfied)., Up to 24 hours postoperative

Kafrelsheikh University

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

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

MKSU 50- 1 - 10

2023-06-01

2023-09-20

2023-09-20

2023-06-07

2023-10-10

Kafrelsheikh University, Kafr Ash Shaykh, Kafrelsheikh, 33516, Egypt

{ "Bupivacaine": [ { "intervention_type": "DRUG", "description": "Bupivacaine 0.25% Injectable Solution", "name": "Bupivacaine", "synonyms": [ "Buvacaina", "Svedocain Sin Vasoconstr", "DL-Bupivacaine", "Marcaine", "Carbostesin", "Bupivacain-RPR", "Bupivacaine Carbonate", "Bupivacaina Braun", "Posimir", "Marcain", "1-Butyl-2',6'-pipecoloxylidide", "Bupivacain RPR", "Bupivacaina", "Bupivacaine Anhydrous", "Bupivacaine Hydrochloride", "Bupivacaine Monohydrochloride, Monohydrate", "1-Butyl-N-(2,6-dimethylphenyl)-2-piperidinecarboxamide", "dl-1-Butyl-2',6'-pipecoloxylidide", "Bupivacain Janapharm", "Bupivacaine", "(RS)-bupivacaine", "Dolanaest", "Bupivacainum", "Racemic bupivacaine", "(\u00b1)-bupivacaine", "Sensorcaine" ], "mesh_id": "D000779", "generic_names": [ "Bupivacaine" ], "drugbank_id": "DB00297", "wikipedia_url": "https://en.wikipedia.org/wiki/Bupivacaine" } ] }

NCT05024487

Prevention of Complications Due to Autonomic Dysreflexia in SCI Individuals

https://clinicaltrials.gov/study/NCT05024487

RECRUITING

Autonomic dysreflexia (AD) is a syndrome of unbalanced response of the sympathetic system to noxious stimuli below the level of spinal cord injury (SCI), characterized by paroxysmal hypertension. Mostly, it is combined with symptoms such as pounding headache, slowed heart rate, and upper body flushing, but it can also be asymptomatic. When resulting in hypertensive crisis, it can be life-threatening and result in seizures, cardiac arrest, retinal or subarachnoid hemorrhages, stroke, and even death. The aim of this study is to determine the risk level of vascular complications in SCI people by correlating the clinical symptoms with their individual perception during AD triggered below the level of injury.

NO

Autonomic Dysreflexia|Spinal Cord Injuries

DIAGNOSTIC_TEST: Clinical Examination

Blood pressure monitoring, Continuous blood pressure and heart rate monitoring will be recorded using Finapres device. The risk level will be determined according to the value of systolic blood pressure (SBP): 1. Low risk - SBP to 150 mmHg 2. Moderate risk - SBP 150-200 mmHg 3. High risk - SBP above 200 mmHg, During the intervention

Dermal sweating, Wrist sweating will be monitored using a measure of dermal resistance with range 0-5 MΩ (difference 0,1 kΩ, accuracy 0,15 %) and 5-32 MΩ (difference 10 kΩ, accuracy 1 %) and sampling frequency 10 second. Regarding the AD symptoms, level of dermal resistance decrease corresponds to increase of sweating., During the intervention|Assessment of symptoms, Subjective individual symptoms are divided into three groups, according to their severity (minimum value: mild symptoms, maximum: strong symptoms): 1. Mild symptoms - shivers on the nape or on the back 2. Moderate symptoms - sweating on the forehead, neck or upper extremities 3. Strong symptoms - pounding headache, nausea, During the intervention|ADFSCI questionnaire, The ADFSCI (Autonomic Dysfunction Following Spinal Cord Injury) questionnaire provides information about individual symptoms of blood pressure (BP) instability. The ADFSCI is a 24-item questionnaire consisting of four parts: demographics, medication, AD, and hypotension. The AD and hypotension parts include 10 and 7 items, respectively, each using a 5-point scale to score the frequency and severity of hyper- or hypotensive symptoms with a range of 0 ∼ 204 (highest BP instability) points., During the intervention

Assoc. Prof. Jiri Kriz, MD, PhD

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

SCI_DYSREFLEXIA_2021

2023-01-01

2023-11-30

2023-12-31

2021-08-27

2023-03-14

Department of Rehabilitation and Sports Medicine, University Hospital Motol, Prague, 150 06, Czechia

{ "Clinical Examination": [ { "intervention_type": "DIAGNOSTIC_TEST" } ] }

NCT02415387

Typhoid Vaccine in Testing Response to Immune Stress in Patients With Stage I-IIIA Breast Cancer

https://clinicaltrials.gov/study/NCT02415387

IMPACT

UNKNOWN

This randomized clinical trial uses an inactive typhoid vaccine to briefly stimulate an immune response in patients with stage I-IIIA breast cancer who received primary cancer treatment and studies whether patients fitness levels affect how their bodies handle a challenge to their immune system. A vaccine is a substance or group of substances meant to cause the immune system to respond to a tumor or to microorganisms such as bacteria or viruses. Immune responses may cause excess inflammation in the body and behavioral changes, such as depression, fatigue, pain, and problems with thinking and reasoning. Studying immune responses in patients with breast cancer who have undergone primary cancer treatment may help doctors learn whether physical fitness can protect the body from effects of immune system stress and whether it may be able to reduce health problems in patients with breast cancer.

NO

Cognitive Side Effects of Cancer Therapy|Depression|Recurrent Breast Carcinoma|Stage IA Breast Cancer|Stage IB Breast Cancer|Stage IIA Breast Cancer|Stage IIB Breast Cancer|Stage IIIA Breast Cancer

BIOLOGICAL: typhoid vaccine|OTHER: Placebo

Change in level of IL-6, Blood will be drawn for IL-6 in serum samples measured using an electrochemiluminescence method with Meso Scale Discovery kits at the fasting baseline and then every 90 minutes post-inoculation for 7.5 hours., At baseline prior to vaccine or placebo administration, and then every 90 minutes post-inoculation for 7.5 hours.

Change in pain, Self-reported intensity of pain on 0-9 scale (0 = no pain; 9 = pain as bad as you can imagine) at baseline prior to vaccine or placebo administration, and then every 90 minutes post-inoculation for the next 7.5 hours, At baseline prior to vaccine or placebo administration, and then every 90 minutes post-inoculation for 7.5 hours.|Change in fatigue, Self-reported intensity of fatigue on 0-9 scales (0 = no fatigue; 9 = fatigue as bad as you can imagine) at baseline prior to vaccine or placebo administration, and then every 90 minutes post-inoculation for the next 7.5 hours, At baseline prior to vaccine or placebo administration, and then every 90 minutes post-inoculation for 7.5 hours.

Ohio State University Comprehensive Cancer Center

FEMALE

ADULT, OLDER_ADULT

EARLY_PHASE1

OTHER

INTERVENTIONAL

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

OSU-13194|NCI-2014-01251

2014-01-01

2022-09-01

2022-09-01

2015-04-14

2022-04-28

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Wexner Medical Center, Columbus, Ohio, 43210, United States

{ "Typhoid vaccine": [ { "intervention_type": "BIOLOGICAL", "description": "typhoid vaccine", "name": "Typhoid vaccine", "synonyms": [ "", "Typhim Vi", "Vivotif", "Typhoid vaccine", "Vivotif", "Typhoid Vaccine", "Vivotif", "Typhoid Vaccine", "Vivotif", "Typhoid Vaccine", "Typherix", "Vi capsular polysaccharide vaccine", "Typhim VI" ], "drugbank_id": "DB14022", "generic_names": [ "Typhoid vaccine", "Typhoid Vaccine", "Typhoid Vaccine", "Typhoid Vaccine" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Typhoid%20vaccine" } ], "Placebo": [ { "intervention_type": "OTHER" } ] }

NCT01641887

Decision Aid for Gastroesophageal Reflux Disease Management

https://clinicaltrials.gov/study/NCT01641887

UNKNOWN

The study is to test a decision aid that is designed to help patients make decision regarding management of their gastroesophageal reflux disease (GERD). Once the decision aid is constructed we will test and assess the aid on ~100 patients who have GERD to assess effectiveness.

NO

Gastroesophageal Reflux Disease|Esophageal Cancer|Barretts Esophagus

OTHER: Decision Aid

Participant acceptability, Patients will be surveyed after using the intervention to determine if they felt it was useful and whether they would recommend it to others., Patients will be surveyed on the day of the decision aid (1 day).|Participant Satisfaction, The Patient Satisfaction with Decision Scale will be adapted for this study. This is a six-item scale has been shown to be reliable and valid., Patients will be surveyed on the day of the decision aid (1 day).

Patient decisions, Patient intervention choice will be solicited both before and after the decision aid., Patients will be surveyed on the day of the decision aid (1 day).

Massachusetts General Hospital

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2012-MGH-Hur-GERD

2014-01

2016-12

2016-12

2012-07-17

2013-04-04

Massachusetts General Hospital, Boston, Massachusetts, 02114, United States

{ "Decision Aid": [ { "intervention_type": "OTHER" } ] }

NCT02696187

Feasibility and Effects of KOL-webben in Patients With COPD

https://clinicaltrials.gov/study/NCT02696187

COMPLETED

This study evaluates the effects of KOL-webben (the COPD web), an interactive web-based system directed towards two target groups; people with chronic obstructive pulmonary disease (COPD) and health professionals in primary care. KOL-webben include tools that improve health literacy with a specific focus on 1) increased physical activity and 2) use of appropriate self-management strategies. Moreover, KOL-webben include knowledge and tools directed towards staff in the primary care aimed to implement provision of evidence based health promotion interventions.The feasibility and effects of KOL-webben will be evaluated.

NO

Pulmonary Disease, Chronic Obstructive

BEHAVIORAL: KOLwebben

Change in impact of COPD in daily life, Impact of COPD in daily life will be assessed using the COPD assessment test., Baseline and 3 months after baseline

Change in health literacy, Health literacy will be assessed using the Swedish C & C HL Scale., Baseline and 3 months after baseline|Change in confidence in managing their COPD, Confidence in managing their COPD will be assessed using questions specifically developed for this study (face validity will be tested), Baseline and 3 months after baseline|Change in aspects of physical activity, Aspects of physical activity will be assessed using the Grimbys Activity Scale, Baseline and 3 months after baseline|Change in aspects of physical activity, Aspects of physical activity will be assessed using indicators about physical activity retrieved from the National Board of Health and Welfare, Baseline and 3 months after baseline|Change in self-efficacy to perform physical activity, Self-efficacy to perform physical activity will be assessed using The SCI Exercise Self-Efficacy Scale (ESES)., Baseline and 3 months after baseline|Change in quality of life, Quality of life will be assessed using the EQ5D., Baseline and 3 months after baseline|Change in dyspnea severity, Dyspnea severity will be assessed using the Medical Research Council Scale., Baseline and 3 months after baseline|Change in level of physical activity, Level of physical activity will be measured with an activity monitor, the DynaPort MiniMod. The activity monitor data collected during 7 Days at baseline and 7 Days 3 months after baseline will be used to assess change in level of physical activity., 7 Days at baseline and and 7 days at 3 months after baseline|Change in instrumental knowledge among health professionals, Instrumental knowledge use of evidence based health promotion interventions will be assessed through a review of medical records; a baseline review of medical record of patients with a COPD diagnosis who have visited the primary care centre during August and September 2015 will be performed and a follow-up review will be performed after the end of the study period., Baseline and 3 months after baseline|Change in conceptual knowledge among health professionals, Conceptual knowledge use (i.e. knowledge, attitudes, and intentions) will be assessed using a questionnaire including both structured and semi-structured questions at baseline and at follow-up, Baseline and 3 months after baseline

Umeå University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

KOLwebben

2016-01-21

2017-05-15

2018-03-15

2016-03-02

2019-08-05

Umeå university, Umeå, Sweden

{ "KOLwebben": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT05326087

Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Women With PCOS Undergoing PGT-A

https://clinicaltrials.gov/study/NCT05326087

NOT_YET_RECRUITING

This randomized trial aims to compare the euploid rate of blastocysts between PPOS (progestin-primed ovarian stimulation) and GnRH (gonadotrophin releasing hormone) antagonist protocols in patients with PCOS (polycystic ovary syndrome) undergoing PGT-A (preimplantation genetic testing for aneuploidy). Infertile women with PCOS will be recruited for study after explanation and counseling if they fulfill the inclusion criteria and do not have the exclusion criteria. Eligible women will be randomised into one of the two groups: Antagonist group: Women will receive antagonist once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger. PPOS group: Women will receive oral MPA (medroxyprogesterone acetate)10mg qd from Day 3 till the day of ovulation trigger. The primary outcome is the euploidy rate of blastocysts.

NO

Preimplantation Genetic Testing|Progestin-primed Ovarian Stimulation|Polycystic Ovarian Syndrome|GnRH Antagonist

DRUG: GnRH antagonist|DRUG: MPA

euploidy rate, euploidy rate of blastocysts, 1 month after oocyte retrieval

live birth rate, deliveries ≥22 weeks gestation with heartbeat and breath of the first frozen embryo transfer, 1 year after embryo transfer|cumulative live birth rate, cumulative live birth within 6 months of randomization, 1 year after embryo transfer|ongoing pregnancy, a viable pregnancy beyond 12 weeks gestation of the first frozen embryo transfer, 12 weeks gestation|number of oocytes retrieved, number of oocytes retrieved, 1 day after oocyte retrieval|OHSS（ovarian hyperstimulation syndrome）, Moderate or severe ovarian hyperstimulation syndrome.Ovarian hyperstimulation syndrome (OHSS) is diagnosed and classified according to the Royal College of Obstetricians and Gynaecologists guideline. Green-top guideline No.5. Ovarian hyperstimulation syndrome. https://www.rcog.org.uk/en/guidelines-research-services/guidelines/gtg5/ (accessed 26 Feb 2016)., 1 month after ovarian stimulation|birthweight of newborns, birthweight of newborns, 1 year after embryo transfer

ShangHai Ji Ai Genetics & IVF Institute

FEMALE

ADULT

PHASE3

OTHER

INTERVENTIONAL

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

JIAI 2022-03

2024-12-01

2025-12-01

2026-12-01

2022-04-13

2024-03-12

{ "Gonadorelin": [ { "intervention_type": "DRUG", "description": "GnRH antagonist", "name": "Gonadorelin", "synonyms": [ "Gonadorelinum", "Gonador\u00e9line", "Gonadorelina", "GnRH", "Gonadorelin", "Gonadotropin-releasing hormone" ], "drugbank_id": "DB00644", "generic_names": [ "Gonadorelin" ] } ], "Medroxyprogesterone acetate": [ { "intervention_type": "DRUG", "description": "MPA", "name": "Medroxyprogesterone acetate", "synonyms": [ "6-alpha-Methyl-17-alpha-acetoxyprogesterone", "6\u03b1-Methyl-17-acetoxy progesterone", "6\u03b1-Methyl-4-pregnene-3,20-dion-17\u03b1-ol acetate", "Methylacetoxyprogesterone", "17-Acetoxy-6\u03b1-methylprogesterone", "Metigestrona", "Medroxyacetate progesterone", "17\u03b1-hydroxy-6\u03b1-methylprogesterone acetate", "(6\u03b1)-17-(Acetyloxy)-6-methylpreg-4-ene-3,20-dione", "6-alpha-Methyl-17-alpha-hydroxyprogesterone acetate", "Medroxyprogesterone acetate", "6\u03b1-Methyl-17\u03b1-hydroxyprogesterone acetate", "MPA", "Medroxyprogesterone 17-acetate" ], "drugbank_id": "DB00603", "generic_names": [ "Medroxyprogesterone acetate" ] } ] }

NCT06415487

ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)

https://clinicaltrials.gov/study/NCT06415487

NOT_YET_RECRUITING

ACE2016 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment of Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR). The ACE2016-001 study is an open-label, Phase I, first-in-human (FIH) study that aims to evaluate the safety and tolerability, persistency, pharmacodynamics and efficacy of ACE2016 in patients with Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR).

NO

Locally Advanced Solid Tumor|Metastatic Solid Tumor

DRUG: Cyclophosphamide|DRUG: Fludarabine|DRUG: ACE2016|DRUG: Pembrolizumab

Incidence of DLTs, AESIs, Grade 3 or higher TEAEs, TEAEs considered related to ACE2016, TEAEs resulting in death, SAEs, related SAEs, and TEAEs leading to treatment discontinuation will be summarized by cohort, 1 year|Change from baseline in clinical laboratory tests results, Number of subject with change from baseline clinical significant lab findings by cohort (descriptive), 1 year|Change from baseline in vital signs results, Number of subjects with change from baseline clinical significant vital signs findings by cohort (descriptive), 1 year|Recommended Dose (RD), 1 year

Persistence of ACE2016 before and after administration, Half-life of ACE2016, 1 year|Measure of anti-ACE2016 antibodies after administration, Titration of anti-ACE2016 antibodies after administration, 1 year|Objective Response Rate (ORR), Proportion of subjects assessed as having a complete response (CR) or partial response (PR) according to RECIST v1.1, 1 year|Disease Control Rate (DCR), Number of subjects with a complete response (CR), partial response (PR) or stable disease (SD) as defined by RECIST v1.1, 1 year|Duration Of Response (DOR), Duration (time) from the first tumor assessment showing response per RECIST v1.1 to the time of disease progression or death., 1 year|Progression Free Survival (PFS), Duration (time) from first ACE2016 cell infusion to first documentation of disease progression per RECIST v1.1 or death, 1 year

Pharmacodynamics of ACE2016, Change from baseline IL2,6,8,10 IFN TNF, and change in TBNK cell subsets., 1 year|gdT infiltration in tumor mass, Optional biopsy to examine gdT cell infiltration, 1 year

Acepodia Biotech, Inc.

ALL

ADULT, OLDER_ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

ACE2016-001

2024-05-31

2026-12-18

2027-03-25

2024-05-16

2024-05-16

SCRI Denver Drug Development Unit, Denver, Colorado, 80218, United States|Sarah Cannon Research Institute (SCRI) Oncology Partners, Nashville, Tennessee, 37203, United States

{ "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" } ], "Fludarabine": [ { "intervention_type": "DRUG", "description": "Fludarabine", "name": "Fludarabine", "synonyms": [ "Fludara", "Fludarabina", "Fludarabine", "2-Fluoro-ara-A Monophosphate, 2-Fluoro-ara AMP, FAMP", "Fludarabinum", "2-fluoro ARA-A", "2-F-ARAA" ], "medline_plus_id": "a692003", "generic_names": [ "Fludarabine" ], "drugbank_id": "DB01073" } ], "ACE2016": [ { "intervention_type": "DRUG" } ], "Pembrolizumab": [ { "intervention_type": "DRUG", "description": "Pembrolizumab", "name": "Pembrolizumab", "synonyms": [ "Keytruda", "Lambrolizumab", "Pembrolizumab" ], "medline_plus_id": "a614048", "generic_names": [ "Pembrolizumab" ], "drugbank_id": "DB09037", "wikipedia_url": "https://en.wikipedia.org/wiki/Pembrolizumab" } ] }

NCT00458887

Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin

https://clinicaltrials.gov/study/NCT00458887

COMPLETED

RATIONALE: New ways to find out about hearing loss after treatment with chemotherapy may improve the ability to plan cancer treatment and may help patients live more comfortably. PURPOSE: This clinical trial is assessing ear damage in young cancer patients treated with cisplatin.

NO

Ototoxicity|Unspecified Childhood Solid Tumor, Protocol Specific

PROCEDURE: management of therapy complications

Incidence of patients with ototoxicity according to Common Toxicity Criteria, American-Speech-Language-Hearing Association, and Brocks criteria, Length of study|Proportion of patients who undergo assessments using ultrahigh frequency (UHF) and evoked otoacoustic emission (OAE) testing, Length of study|Proportion of patients with complete standard audiometry data (excluding UHF and OAE evaluations), Length of Study

Childrens Oncology Group

National Cancer Institute (NCI)

ALL

CHILD, ADULT

NETWORK

OBSERVATIONAL

Observational Model: |Time Perspective: p

ACCL05C1|COG-ACCL05C1|CDR0000538247

2007-05

2015-01

2017-02-28

2007-04-11

2017-03-13

UAB Comprehensive Cancer Center, Birmingham, Alabama, 35294, United States|Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States|Childrens Hospital Los Angeles, Los Angeles, California, 90027, United States|Southern California Permanente Medical Group, Los Angeles, California, 90027, United States|Childrens Hospital Central California, Madera, California, 93638-8762, United States|Lucile Packard Childrens Hospital at Stanford University Medical Center, Palo Alto, California, 95798, United States|Rady Childrens Hospital - San Diego, San Diego, California, 92123-4282, United States|UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, 94115, United States|Connecticut Childrens Medical Center, Hartford, Connecticut, 06106, United States|Yale Cancer Center, New Haven, Connecticut, 06520-8028, United States|Alfred I. duPont Hospital for Children, Wilmington, Delaware, 19803, United States|Lee Cancer Care of Lee Memorial Health System, Fort Myers, Florida, 33901, United States|Nemours Childrens Clinic, Jacksonville, Florida, 32207, United States|University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida, 33136, United States|Florida Hospital Cancer Institute at Florida Hospital Orlando, Orlando, Florida, 32803-1273, United States|Nemours Childrens Clinic - Orlando, Orlando, Florida, 32806, United States|Nemours Childrens Clinic - Pensacola, Pensacola, Florida, 32504, United States|All Childrens Hospital, Saint Petersburg, Florida, 33701, United States|St. Josephs Cancer Institute at St. Josephs Hospital, Tampa, Florida, 33607, United States|Cancer Research Center of Hawaii, Honolulu, Hawaii, 96813, United States|Mountain States Tumor Institute at St. Lukes Regional Medical Center, Boise, Idaho, 83712-6297, United States|University of Illinois Cancer Center, Chicago, Illinois, 60612-7243, United States|Saint Jude Midwest Affiliate, Peoria, Illinois, 61603, United States|Rileys Children Cancer Center at Riley Hospital for Children, Indianapolis, Indiana, 46202, United States|Blank Childrens Hospital, Des Moines, Iowa, 50309, United States|Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, 52242-1002, United States|Kosair Childrens Hospital, Louisville, Kentucky, 40232, United States|Tulane Cancer Center Office of Clinical Research, Alexandria, Louisiana, 71315-3198, United States|Childrens Hospital of New Orleans, New Orleans, Louisiana, 70118, United States|National Naval Medical Center, Bethesda, Maryland, 20889-5600, United States|C.S. Mott Childrens Hospital at University of Michigan Medical Center, Ann Arbor, Michigan, 48109-0286, United States|Hurley Medical Center, Flint, Michigan, 48503, United States|Helen DeVos Childrens Hospital at Spectrum Health, Grand Rapids, Michigan, 49503, United States|Bronson Methodist Hospital, Kalamazoo, Michigan, 49007-5381, United States|Childrens Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota, 55404, United States|Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, 55455, United States|Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States|Childrens Mercy Hospital, Kansas City, Missouri, 64108, United States|Cardinal Glennon Childrens Hospital, St. Louis, Missouri, 63104, United States|CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada, 89109-2306, United States|Hackensack University Medical Center Cancer Center, Hackensack, New Jersey, 07601, United States|Newark Beth Israel Medical Center, Newark, New Jersey, 07112, United States|Carol G. Simon Cancer Center at Morristown Memorial Hospital, Summit, New Jersey, 07901, United States|University of New Mexico Cancer Center, Albuquerque, New Mexico, 87131-5636, United States|Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York, 10032, United States|SUNY Upstate Medical University Hospital, Syracuse, New York, 13210, United States|New York Medical College, Valhalla, New York, 10595, United States|Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, 28233-3549, United States|Duke Cancer Institute, Durham, North Carolina, 27710, United States|Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, 27157-1096, United States|Cincinnati Childrens Hospital Medical Center, Cincinnati, Ohio, 45229-3039, United States|Rainbow Babies and Childrens Hospital, Cleveland, Ohio, 44106-5000, United States|Nationwide Childrens Hospital, Columbus, Ohio, 43205-2696, United States|Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, 73104, United States|Legacy Emanuel Childrens Hospital, Portland, Oregon, 97227, United States|Knight Cancer Institute at Oregon Health and Science University, Portland, Oregon, 97239-3098, United States|Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania, 18017, United States|Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania, 17822-0001, United States|Childrens Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, 15213, United States|Rhode Island Hospital Comprehensive Cancer Center, Providence, Rhode Island, 02903, United States|Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota, 57117-5039, United States|East Tennessee Childrens Hospital, Knoxville, Tennessee, 37916, United States|Driscoll Childrens Hospital, Corpus Christi, Texas, 78411, United States|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, 75390, United States|University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78207, United States|Methodist Childrens Hospital of South Texas, San Antonio, Texas, 78229-3993, United States|Inova Fairfax Hospital, Falls Church, Virginia, 22042-3300, United States|Childrens Hospital of The Kings Daughters, Norfolk, Virginia, 23507-1971, United States|Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, 23298-0037, United States|Childrens Hospital and Regional Medical Center - Seattle, Seattle, Washington, 98105, United States|Providence Cancer Center at Sacred Heart Medical Center, Spokane, Washington, 99220-2555, United States|St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, 54307-3508, United States|Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, 54449, United States|Princess Margaret Hospital for Children, Perth, Western Australia, 6001, Australia|Childrens and Womens Hospital of British Columbia, Vancouver, British Columbia, V6H 3V4, Canada|CancerCare Manitoba, Winnipeg, Manitoba, R3E 0V9, Canada|IWK Health Centre, Halifax, Nova Scotia, B3J 3G9, Canada|Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada|Hopital Sainte Justine, Montreal, Quebec, H3T 1C5, Canada|Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon, Saskatchewan, S7N 4H4, Canada|Centre Hospitalier Universitaire de Quebec, Quebec, G1V 4G2, Canada

{ "management of therapy complications": [ { "intervention_type": "PROCEDURE" } ] }

NCT00285987

Quality of Life After an Ambulatory Reconstruction of the Cruciate Ligament

https://clinicaltrials.gov/study/NCT00285987

WITHDRAWN

Study to compare the quality of life after reconstruction of the cruciate ligament in hospitalized versus day-clinic patient

NO

Rupture of the Cruciate Ligament

PROCEDURE: Reconstruction of the cruciate ligament

Quality of life

University Hospital, Ghent

ALL

ADULT

OTHER

INTERVENTIONAL

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

2000/282

2006-02-02

2021-07-07

{ "Reconstruction of the cruciate ligament": [ { "intervention_type": "PROCEDURE" } ] }

NCT04325087

Reduction of Trauma-induced Intrusions and Amygdala Hyperreactivity Via Non-invasive Brain Stimulation

https://clinicaltrials.gov/study/NCT04325087

COOL

UNKNOWN

The study will focus on the modulation of intrusive memories via functional magnetic resonance imaging (fMRI)-guided repetitive transcranial magnetic stimulation of the dorsolateral prefrontal cortex (dlPFC) directly after exposure to a traumatic video.

NO

Intrusive Thoughts|Post Traumatic Stress Disorder

DEVICE: iTBS|DEVICE: Placebo iTBS

Number and quality of intrusive thoughts, Sum and stress ratings of intrusive thoughts measured on three consecutive days after trauma exposure by an online questionnaire., Three days after trauma exposure|Changes in resting state functional connectivity, Functional connectivity data will be assessed by two 10-minutes resting state fMRI scans before and after three sessions of TMS treatment over the course of three days. The resting state fMRI analysis will focus on changes in functional connectivity between regions-of-interest (ROIs) associated with intrusive memories (prefrontal cortex, amygdala, precuneus, insula, hippocampus, cingulate cortex). Changes in functional connectivity between the first and second fMRI sessions will be computed on the first level and independent t-tests will be used to compare the verum and sham TMS groups., 10-minutes resting state fMRI scans before and after three sessions of TMS treatment|Changes in neural response to an emotion recognition task, Changes between the first and second fMRI session in the blood-oxygen-level-dependent (BOLD) signal in response to happy, fearful and neutral faces as well as houses will be compared between the experimental groups. Analysis will focus on anatomically defined regions-of-interest (ROI) associated with emotion processing (i.e. amygdala, prefrontal cortex, insula, striatal areas). Changes in the neural response and functional connectivity between the first and second fMRI sessions will be computed on the first level and independent t-tests will be used to compare the verum and sham TMS groups. For analyses of fMRI data, standard procedures of the software SPM12 will be used., 15-minutes emotional face matching fMRI task before and after three sessions of TMS treatment

Changes in executive functioning (One Touch Stockings of Cambridge) and attention (Rapid Visual Information Processing) during iTBS treatment, Cognitive tasks conducted with the CanTab software will be used to measure executive functioning (One Touch Stockings of Cambridge) and attention (Rapid Visual Information Processing) on four different time points during the treatment (pre/post first iTBS, pre/post last iTBS). Changes in executive functioning and attention will be tested as moderator variables of other TMS effects., 15-minutes cognitive tasks pre/post first iTBS and pre/post last iTBS treatment|Trauma disclosure, Trauma disclosure will be measured by online questionnaires on days 2-4. Subjects will be asked to report the number and duration (in minutes) of conversations about the video. Furthermore, subjects have to report to who they talked with about the video. Trauma disclosure will be tested as a moderator variable of TMS effects., Three days after trauma exposure|Changes in electrodermal responses to the trauma video, Electrodermal responses will be recorded by a BioNomadix System (BIOPAC Systems Inc., Santa Barbara, USA) during a 5-minutes baseline before the start of the trauma video and during the trauma video with two electrodes attached to palm of the right hand., 5 minutes before and during the trauma video|Respiratory changes in response to the trauma video, Respiratory rate will be recorded by a BioNomadix System (BIOPAC Systems Inc., Santa Barbara, USA) during a 5-minutes baseline before the start of the trauma video and during the trauma video with belt attached to the subjects chest. Data will be analyzed for changes in breathing frequency and amplitude in response to the trauma video., 5 minutes before and during the trauma video|Heart rate changes in response to the trauma video, Heart rate will be recorded by a BioNomadix System (BIOPAC Systems Inc., Santa Barbara, USA) during a 5-minutes baseline before the start of the trauma video and during the trauma video., 5 minutes before and during the trauma video|Changes in positive and and negative affect in response to the trauma video, Changes in positive and negative affect will be measured by the PANAS (Positive and Negative Affect Schedule) questionnaire 10 minutes before and 10 minutes after trauma exposure. The PANAS questionnaire consists of two subscale: 1. positive affect (minimum rating = 5, maximum rating = 50), 2. negative affect (minimum rating = 5, maximum rating = 50)., 10 minutes before and 10 minutes after trauma exposure|Changes in anxiety in response to the trauma video, Changes in anxiety will be measured by the STAI-Trait (State-Trait Anxiety Inventory) questionnaire immediately 10 minutes before and 10 minutes after trauma exposure.(minimum rating = 20, maximum rating = 80, higher values indicate more state anxiety)., 10 minutes before and 10 minutes after trauma exposure|Dissociative symptoms after trauma exposure, Dissociative symptoms after the trauma video will be measured by questionnaires (Dissociation-Tension-Scale acute) and tested as a moderator variable of TMS effects. Subjects score between 0 and 9, with higher values indicating more dissociative symptoms., 10 minutes after trauma exposure|Childhood maltreatment, The Childhood Trauma Questionnaire (CTQ) will be used to measure childhood maltreatment. The scale ranges between 5 and 100 points and higher scores indicate higher childhood maltreatment. CTQ scores will be tested as moderator variable of TMS effects., Before first fMRI scan|Sleep quality: visual analog scales, Sleep quality (delay in sleep onset, calmness, depth of sleep, nightmares, nightly awakenings) will be measured with visual analog scales from 0 to 100. Higher scores represent poor sleep quality., Three days after trauma exposure|Delayed discounting task, To test changes in PFC-associated control of impulsive preferences, subjects will perform a delayed discounting paradigm. Participants will be asked to choose between small immediate rewards and larger later rewards. This task will be conducted twice (before and after the iTBS sessions)., Before and three days after trauma exposure|Food craving task, Food craving will be measured twice (before and after the iTBS sessions). Participants will be confronted with pictures of candy and dessert in two types of trials. In NOW trials, participants will be instructed to consider the immediate consequence of consuming the pictured food, while LATER trials will direct participants to think about the long-term consequences., Before and three days after trauma exposure

University Hospital, Bonn

ALL

ADULT

OTHER

INTERVENTIONAL

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

COOL

2019-07-01

2020-05-30

2020-05-30

2020-03-27

2020-03-27

Department of Psychiatry, University of Bonn, Bonn, 53105, Germany

{ "iTBS": [ { "intervention_type": "DEVICE" } ], "Placebo iTBS": [ { "intervention_type": "DEVICE" } ] }

NCT03119987

Predictive Role of Red Cell Distribution Width in Upper GI Bleeding Patients

https://clinicaltrials.gov/study/NCT03119987

COMPLETED

Acute upper-gastrointestinal bleeding (UGIB) is a commonly encountered cause of admission in emergency department (ED). Early risk stratification allows appropriate therapy that may be helpful to advance the patients morbidity and mortality. Investigators hypothesized that early RDW levels may have an independent, linear relationship with recurrent or massive bleeding in UGIB patients.

NO

Gastrointestinal Hemorrhage

DIAGNOSTIC_TEST: Red cell distribution widths

High risk, Case of the death or re-bleeding, or blood transfusion or endoscopic therapy or operation., 30 days

Konkuk University Medical Center

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

RDWUGI

2011-01-01

2012-12-30

2014-12-30

2017-04-19

2018-03-07

{ "Red cell distribution widths": [ { "intervention_type": "DIAGNOSTIC_TEST" } ] }

NCT01920087

Efficacy and Safety of ATNC05 in Treatment of Atypical Facial Pain

https://clinicaltrials.gov/study/NCT01920087

AFP

WITHDRAWN

The purpose of the study is to test the efficacy of ATNC05 in the treatment of Atypical Facial Pain (AFP), also known as Persistent Idiopathic Facial Pain (PIFP). This research project targets patients with chronic constant facial pain and excludes patients with primarily paroxysmal pain.

NO

Atypical Facial Pain|Persistent Idiopathic Facial Pain|Atypical Trigeminal Neuralgia|Neuropathic Orofacial Pain|Neuropathic Facial Pain

DRUG: ATNC05|DRUG: Placebo

Mean Change from Baseline Period Mean in Average Pain Intensity at Weeks 9-12, The Brief Pain Inventory measures pain severity on an 11-point Likert Scale from 0 (no pain) to 10 (worst pain imaginable)., Baseline to Weeks 9-12

Mean Change from Baseline Period Mean in BPI-S Measurements (Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Right-Now Pain Intensity, and Night Pain Intensity), The Brief Pain Inventory - Severity measures pain severity on an 11-point Likert Scale from 0 (no pain) to 10 (worst pain imaginable)., Baseline to Weeks 1-4, Weeks 5-8, and Weeks 9-12|Mean Change from Baseline Period Mean in BPI-I Measurements (General Activity, Mood, Chewing Ability, Normal Work, Relationships, Sleep Quality, Enjoyment of Life, Talking, and Teeth Brushing), The Brief Pain Inventory - Interference measures interference with the listed activities on an 11-point Likert Scale from 0 (does not interfere) to 10 (completely interferes))., Baseline to Weeks 1-4, Weeks 5-8, and Weeks 9-12|Patient Global Impression of Improvement, The PGI-I measures subjects assessment of how much relief the study medication provides on a scale of 0% to 100%, in increments of 10%., Weeks 1-4, Weeks 5-8, and Weeks 9-12|Responder Analysis of CGI-S, The Clinical Global Impression - Severity scale measures the severity of the subjects condition on a seven point scale: normal, borderline, mild, moderate, marked, severe, or extreme, Week 1, Week 4, Week 8, Week 12|Responder Analysis of CGI-I, The Clinical Global Impression - Improvement scale measures the improvement of the subjects condition on a seven-point Likert scale: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse., Week 1, Week 4, Week 8, Week 12|Number of Doses of Additional Pain Medication Taken, The amount of additional analgesic medication needed for rescue purposes., Weeks 1-4, Weeks 5-8, and Weeks 9-12|AFP Pain Disability Index, The AFP Disability Index assesses the disability caused by AFP in various life activities. It is scored on a scale of 0-100., Week 1, Week 4, Week 8, Week 12|Pittsburgh Insomnia Rating Scale 20, The PIRS-20 assesses the difficulty the subject has had with sleeping in the previous week. It is scored on a scale of 0-60., Week 1, Week 4, Week 8, Week 12

Allodynic Therapeutics, Inc

ALL

ADULT, OLDER_ADULT

PHASE2|PHASE3

INDUSTRY

INTERVENTIONAL

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

AFP-001

2014-03

2016-03

2016-07

2013-08-09

2014-03-13

Annette C. Toledano MD, North Miami, Florida, 33181, United States

{ "ATNC05": [ { "intervention_type": "DRUG" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT05132387

Wroclaw Out-Of-Hospital Cardiac Arrest Registry

https://clinicaltrials.gov/study/NCT05132387

WOHCA

RECRUITING

The purpose of this study is to assess the efficacy of institutionalized care program of patients with out-of-hospital cardiac arrest.

NO

Out-Of-Hospital Cardiac Arrest

OTHER: ECMO assisted CPR in out-of-hospital cardiac arrest

mortality, all cause mortality, 1 month

degree of disability, Modified Rankin Scale of 3 or lower, 3 and 6 months after index event

Wroclaw Medical University

Wroclaw Emergency Medical Services

ALL

ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

327/2021

2021-10-25

2024-10-31

2025-01-01

2021-11-24

2024-06-11

Wroclaw University Hostpital, Wroclaw, 50-556, Poland

{ "ECMO assisted CPR in out-of-hospital cardiac arrest": [ { "intervention_type": "OTHER" } ] }

NCT04087187

A Study to Assess the Drug Absorption Into the Blood After Administration of 3 Doses of AZD5718

https://clinicaltrials.gov/study/NCT04087187

COMPLETED

This study will be conducted to evaluate the AZD5718 pharmacokinetic (PK) doses in order to determine exposure in a new dose range and compare with previous results. This study will include 14 subjects in a single site in United Kingdom. Each subject will be involved in the study for 6 to 7 weeks.

NO

Coronary Artery Disease

DRUG: Treatment A|DRUG: Treatment B|DRUG: Treatment C

Pharmacokinetic parameter: Area under plasma concentration time curve from zero to infinity (AUC), To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718, Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose|Pharmacokinetic parameter: Area under the plasma concentration curve from time zero to time of last quantifiable concentration (AUClast), To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718, Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose|Pharmacokinetic parameter: Maximum observed plasma concentration (Cmax), To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718, Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose|Pharmacokinetic parameter: Drug concentration 24 hours after dosing (C24), To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718, Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose|Pharmacokinetic parameter: Half life associated with terminal slope (λz) of a semi logarithmic concentration time curve (t1/2λz), To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718, Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose|Pharmacokinetic parameter: Time to reach maximum observed plasma concentration (tmax), To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718, Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose|Pharmacokinetic parameter: Apparent total body clearance of drug from plasma after extravascular administration (CL/F), To evaluate the pharmacokinetics and exposure of 3 different doses of AZD5718, Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose

Number of subjects with advers event, Number of subjects with adverse event and/or abnormal vital signs or physical examination or laboratory assessments to further assess the safety of single doses of AZD5718 in healthy subjects., Upto 7 weeks|Pharmacokinetic parameter: AUC, To assess dose proportionality of AZD5718, Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose|Pharmacokinetic parameter: Cmax, To assess dose proportionality of AZD5718, Day 1: Pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours post dose, Day 2: 24 and 36 hours post dose and Day 3: 48 hours post dose

AstraZeneca

Parexel

ALL

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

D7550C00009

2019-09-20

2019-10-31

2019-10-31

2019-09-12

2019-11-15

Research Site, London, HA1 3UJ, United Kingdom

{ "Treatment A": [ { "intervention_type": "DRUG" } ], "Treatment B": [ { "intervention_type": "DRUG" } ], "Treatment C": [ { "intervention_type": "DRUG" } ] }

NCT00672087

Diagnostic Challenges in IC (and Male CPPS)

https://clinicaltrials.gov/study/NCT00672087

COMPLETED

The etiology and pathogenesis of interstitial cystitis (IC) and its related condition in men, chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has remained elusive. This has hampered development of mechanistic treatment strategies for these common, chronic and distressing medical conditions. We believe that IC and perhaps CP/CPPS are a spectrum of complex but inter-related genetic and acquired diseases resulting from the interaction of several genes regulating immune/inflammatory and neurogenic parameters and environmental factors/circumstances or exposure, culminating in the combination of pain, frequency, urgency and sexual specific symptoms. New research has delineated the dynamic and powerful association of the immune and neurogenic system in pain activation. An immune-modulated neurogenic model of IC illuminating the action of immune derived substances and pain related substances might be important in discovering the determinants of pain, voiding dysfunction and gender specific sexual problems. This inter-related dynamic model of IC disease pathogenesis could be explored for potential avenues leading to novel diagnostic and treatment strategies. We plan to identify and evaluate the sensitivity and specificity of several novel nerve and inflammation related markers in the diagnosis and follow up of IC (and CP/CPPS). By correlating the levels of urine immune and pain related substances to disease mechanisms, severity and progression, we may be able to create a human disease specific model for diagnosis and treatment.

NO

Chronic Prostatitis With Chronic Pelvic Pain Syndrome|Chronic Bacterial Prostatitis|Asymptomatic Inflammatory Prostatitis|Painful Bladder Syndrome|Cystitis, Interstitial

GENETIC: Genomic and proteomic biomarker discovery

Beth Israel Deaconess Medical Center

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

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2010P000229|R01DK065990

2003-09

2011-06

2011-06

2008-05-06

2020-08-04

Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States

{ "Genomic and proteomic biomarker discovery": [ { "intervention_type": "GENETIC" } ] }

NCT05610787

EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study

https://clinicaltrials.gov/study/NCT05610787

RECRUITING

The purpose of this study is to evaluate the device performance and monitor the safety and effectiveness of the Berlin Heart EXCOR Active Driving System while being used with the approved EXCOR Pediatric Ventricular Assist Device. EXCOR Active Driving System is intended for use with the approved EXCOR Pediatric VAD. The EXCOR Pediatric VAD is intended to provide mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. Pediatric candidates with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support may be treated using the EXCOR Pediatric. EXCOR Active is intended for use in a clinical setting. EXCOR Active can be used in any kind of hospital unit (e.g. OR, ICU, intermediate care unit or general care unit). The driving unit may be moved between clinical units using the caddy or baby buggy; however, a patient must always be accompanied by a person trained in the use of the manual pump and emergency procedures during transport in the event of an emergency. The driving unit can be transported during operation.

NO

Heart Failure|Transplant; Failure, Heart|Congenital Heart Disease

DEVICE: EXCOR Active Driving System for Pediatric VAD

Rate of Device Malfunction adverse events, A Device Malfunction per protocol definition, and adjudicated by the Clinical Events Committee., Up to 90 days|Patient Outcome, Patient outcomes will be summarized as the proportion of subjects experiencing each outcome and the overall successful outcome. Successful outcome is defined as: * survival to recovery/successful weaning -or- * survival to explantation not attributed to device malfunction -or- * survival on EXCOR® Pediatric at 90 days post-implant Patients who are removed from support followed by death or for escalation to other therapy (such as another VAD or ECMO) due to major device malfunction attributed to the Active Driving System will be considered failures., Up to 90 days|Serious Adverse Events, Serious Adverse Event rates will be calculated as the rate per 100 patient-months for each individual event as defined in protocol., Up to 90 days

Berlin Heart, Inc

ALL

CHILD, ADULT

INDUSTRY

INTERVENTIONAL

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

G200252

2022-11-14

2023-09

2024-01

2022-11-09

2023-02-08

Childrens Hospital of Los Angeles, Los Angeles, California, 90027, United States|Lucile Packard Childrens Hospital-Stanford, Palo Alto, California, 94304, United States|Childrens Hospital Colorado, Aurora, Colorado, 80045, United States|Childrens National, Washington, District of Columbia, 20010, United States|Boston Childrens Hospital, Boston, Massachusetts, 02115, United States|St Louis Childrens Hospital, Saint Louis, Missouri, 63110, United States|Levine Childrens Hospital, Charlotte, North Carolina, 28203, United States|Cincinnati Childrens Hospital Medical Center, Cincinnati, Ohio, 45229, United States|Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States|Primary Childrens Hospital, Salt Lake City, Utah, 84113, United States|Childrens Hospital Wisconsin, Milwaukee, Wisconsin, 53201, United States

{ "EXCOR Active Driving System for Pediatric VAD": [ { "intervention_type": "DEVICE" } ] }

NCT03827187

Awareness Detection and Communication in Disorders of Consciousness

https://clinicaltrials.gov/study/NCT03827187

RECRUITING

STUDY OVERVIEW Brain injury can result in a loss of consciousness or awareness, to varying degrees. Some injuries are mild and cause relatively minor changes in consciousness. However, in severe cases a person can be left in a state where they are awake but unaware, which is called unresponsive wakefulness syndrome (UWS, previously known as a vegetative state). Up to 43% of patients with a UWS diagnosis, regain some conscious awareness, and are then reclassified as minimally conscious after further assessment by clinical experts. Many of those in the minimally conscious state (MCS) and all with unresponsive wakefulness syndrome (UWS) are incapable of providing any, or consistent, overt motor responses and therefore, in some cases, existing measures of consciousness are not able to provide an accurate assessment. Furthermore, patients with locked-in syndrome (LIS), which is not a disorder of consciousness as patients are wholly aware, also, struggle to produce overt motor responses due to paralysis and anarthria, leading to long delays in accurate diagnoses using current measures to determine levels of consciousness and awareness. There is evidence that LIS patients, and a subset of patients with prolonged disorders of consciousness (DoC), can imagine movement (such as imagining lifting a heavy weight with their right arm) when given instructions presented either auditorily or visually - and the pattern of brain activity that they produce when imagining these movements, can be recorded using a method known as electroencephalography (or EEG). With these findings, the investigators have gathered evidence that EEG-based bedside detection of conscious awareness is possible using Brain- Computer Interface (BCI) technology - whereby a computer programme translates information from the users EEG-recorded patterns of activity, to computer commands that allow the user to interact via a user interface. The BCI system for the current study employs three possible imagined movement combinations for a two-class movement classification; left- vs right-arm, right-arm vs feet, and left-arm vs feet. Participants are trained, using real-time feedback on their performance, to use one of these combinations of imagined movement to respond to yes or no answer questions in the Q&A sessions, by imagining one movement for yes and the other for no. A single combination of movements is chosen for each participant at the outset, and this participant-specific combination is used throughout their sessions. The study comprises three phases. The assessment Phase I (sessions 1-2) is to determine if the patient can imagine movements and produce detectable modulation in sensorimotor rhythms and thus is responding to instructions. Phase II (sessions 3-6) involves motor-imagery (MI) -BCI training with neurofeedback to facilitate learning of brain activity modulation; Phase III (sessions 7-10) assesses patients MI-BCI response to closed questions, categorized to assess biographical, numerical, logical, and situational awareness. The present study augments the evidence of the efficacy for EEG-based BCI technology as an objective movement-independent diagnostic tool for the assessment of, and distinction between, PDoC and LIS patients.

NO

Disorder of Consciousness|Paralysis|Motor Neuron Disease|Stroke|Physical Disability

OTHER: Motor imagery based EEG-BCI

Change in performance accuracy of BCI use pre- and post- training, The main primary outcome measure is BCI performance (e.g., accuracy in % for repeated binary choice selections using the BCI e.g., movement free control of cursor towards one of two targets using EEG-based BCI or accuracy in discriminating different brain responses associated with imagined movement of different limbs. Multiple cross validation will be performed to assess the significance of the difference between a baseline accuracy (pre cue- where accuracy in the response is expected to be around 50% (chance level)) and the peak accuracy (where the accuracy of discriminating event related brain response peaks following the cue)., ~10 sessions of ~1.5 hours|Change in ability to use imagined movements to consistently communicate yes-no responses to closed questions over multiple sessions by participant with Prolonged Disorder of Consciousness, Accuracy rate when using the BCI system to provide known responses to statements will be used to build evidence to establish that participants could use the technology as an aided communication method. Examples of questions are given below. Yes Questions: Your name is David. You are 25 years old., 3-4 sessions of ~1.5 hours

Diagnostic utility of BCI data provided through study completion to clinicians, The performance accuracy of the participant in producing consistent cue- induced imagined movements appropriately in timed paradigms will be assessed across sessions, to determine variability and consistency in performance accuracy. The affects of real-time feedback will be looked at, alongside differences in performance accuracy across question subcategories. Performance accuracy per question subcategory will be assessed to evaluate awareness of self versus awareness of environment and understanding of numbers and letters, and logic. Whether this information is in line with the patients current diagnosis/CRS-R and WHIM scores will be assessed in order to further understand whether the technology can aid feedback/interpretation on assessment outcomes from consultants?, 2 - 7 weeks. Duration of study which lasts 10 sessions of ~1.5 hours in addition to some time for analysis/reporting of results|Changes in Wessex Head Injury Matrix and Coma Recovery Scale Scores due to potential therapeutic benefit of engaging in motor imagery, Is there a benefit to intentionally modulating motor cortex regions in response to a command in a timed paradigm over multiple sessions. In participants with a Prolonged Disorder of Consciousness the scores for The Wessex Head Injury Matrix and Coma-Recovery Scale Revised taken at each session will be looked at to seek out therapeutic benefit. Here therapeutic benefit is defined in terms of changes in state of arousal and awareness of self/environment. Therapeutic benefit may also be assessed via performance given as an accuracy percentage of motor imagery trials successfully completed, and how this changes over time., ~10 sessions of ~1.5 hours|Change in performance accuracy as a factor of whether feedback was presented as music or broadband noise,, Is there a significant difference in performance as a function of type of feedback participant was receiving - music clips or broadband noise., ~10 sessions of ~1.5hours|Changes in performance accuracy as a results of time of day of research experimentation, Arousability varies with time of day - is this reflected in BCI use performance or do some patients perform more optimally at a particular time? The aim is to perform 5 sessions in the morning and 5 in the afternoon to look at the affects of time of day., ~10 sessions of ~1.5hours

University of Ulster

National Rehabilitation Hospital, Ireland|Belfast Health and Social Care Trust|Western Health and Social Care Trust|Southern Health and Social Care Trust|Northern Health and Social Care Trust|Barnsley Hospital NHS Foundation Trust|NHS Lothian|Walton Centre NHS Foundation Trust|Hull University Teaching Hospitals NHS Trust|Imperial College Healthcare NHS Trust|Royal Hospital for Neuro-disability|South Warwickshire NHS Foundation Trust|Sheffield Teaching Hospitals NHS Foundation Trust|Oxford University Hospitals NHS Trust|Castel Froma Neuro Care|Inspire Neurocare|The Huntercombe Group|Active Care Group

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

136640

2022-02-08

2026-08

2026-08

2019-02-01

2023-07-03

National Rehabilitation Hospital of Ireland, Dublin, A96 E2H2, Ireland|Castel Froma Neuro Care, Warwick, Warwickshire, CV32 6LL, United Kingdom|Northern Health and Social Care Trust, Antrim, BT41 2RL, United Kingdom|Barnsley Hospital NHS Foundation Trust, Barnsley, S75 2EP, United Kingdom|Belfast Health and Social Care Trust, Belfast, BT9 7AB, United Kingdom|Frenchay Brain Injury Rehabilitation Centre, Bristol, BS16 2UU, United Kingdom|NHS Lothian, Edinburgh, EH9 2HL, United Kingdom|Hull University Teaching Hospitals NHS Trust, Hull, HU3 2JZ, United Kingdom|The Walton Centre NHS Foundation Trust, Liverpool, L9 7LJ, United Kingdom|Western Health and Social Care Trust, Londonderry, BT47 6SB, United Kingdom|The Huntercombe Group, London, SE10 8AD, United Kingdom|Royal Hospital for Neuro-Disability, London, SW15 3SW, United Kingdom|Imperial College Healthcare NHS Trust, London, W6 8RF, United Kingdom|Oxford University Hospitals NHS Foundation Trust, Oxford, OX3 7HE, United Kingdom|Southern Health and Social Care Trust, Portadown, BT63 5QQ, United Kingdom|Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, S10 2JF, United Kingdom|South Warwickshire NHS Foundation Trust, Warwick, CV34 5BW, United Kingdom|Inspire Neurocare Worcester, Worcester, WR2 6AS, United Kingdom

{ "Motor imagery based EEG-BCI": [ { "intervention_type": "OTHER" } ] }

NCT01329887

The Effect of Ketanserin on the Microcirculation in Sepsis

https://clinicaltrials.gov/study/NCT01329887

COMPLETED

This study is an evaluation of the effect of ketanserine on sublingual microcirculation in intensive care patients with severe sepsis.

NO

Severe Sepsis|Septic Shock

DRUG: ketanserin

microcirculation, achievement of a microvascular flow index >2,9, 2 hours

ketanserine dosage, obtaining a global indication of the ketanserin dosage needed to achieve a MFI >2,9 and the incidence of hypotension, 48 hours

Medical Centre Leeuwarden

ALL

ADULT, OLDER_ADULT

PHASE3

OTHER

INTERVENTIONAL

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

TPO 736

2011-03

2014-05

2014-05

2011-04-06

2014-05-09

Medical Centre Leeuwarden, Leeuwarden, Netherlands

{ "Ketanserin": [ { "intervention_type": "DRUG", "description": "ketanserin", "name": "Ketanserin", "synonyms": [ "R 41468", "R41,468", "3-(2-(4-(4-Fluorobenzoyl)piperidinol)ethyl)-2,4(1H,3H)-quinazolinedione", "Ketanserin", "R 41,468", "ketanserina", "R-41,468", "R41468", "R-41468" ], "mesh_id": "D012702", "generic_names": [ "Ketanserin" ], "drugbank_id": "DB12465" } ] }

NCT01461187

Effects in Type of Birth of Physical Exercise During Pregnancy

https://clinicaltrials.gov/study/NCT01461187

COMPLETED

Abstract: Objectives:[The goal is] to confirm if physical activity of medium intensity performed during gestation can influence the way of delivery, and observe the adherence to exercise among pregnant women with different education levels. Methods: Held at the Center for Breastfeeding Incentive in the city of São Sebastião, State of São Paulo (Brazil), between April 7, 2008 and April 14, 2009, the prospective study involved 66 primigravid women, who were divided into two groups: the exercise group (GE) that exercised regularly during pregnancy, and the other control group (GC) that did not exercise regularly during same period. The significance level adopted in this study was five per cent (p = 0.05).

NO

Pregnancy

OTHER: exercise during pregnancy

Predomination of type of birth, vaginal birth or Cesarean section among pregnant women participating in the exercise group and the control group., Of the 66 volunteers, 37 were part of the exercise group (EG) and 29 of the control group (CG). Of the 37 in the control group, 25 had vaginal birth, while 12 had a Cesarean. In contrast, of the 29 in the CG, 11 had vaginal birth and 18 had a Cesarean., Research conducted between April 7, 2008 and April 14, 2009 (one year)

Adhesion to exercise among the pregnant women with undergraduate and elementary education., Of the 66 volunteers, 12 had undergraduate education. Of these, 11 were part of the EG and one of the CG. In contrast, 15 of the 66 pregnant volunteers had primary education, six of which were part of the EG, while nine were part of the CG., The investigation lasted for one year

Hospital do Servidor Publico Estadual

Maternal Breastfeeding Incentive Center (CIAMA)

FEMALE

ADULT

OTHER

INTERVENTIONAL

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

Líliancsilveira

2008-04

2009-01

2009-04

2011-10-27

2011-10-27

center of encouraging breastfeeding (CIAMA), São Sebastião, São Paulo, 11600-000, Brazil

{ "exercise during pregnancy": [ { "intervention_type": "OTHER" } ] }

NCT02170987

Assessment of Electrophysiological Effects of Dabigatran Etexilate as Single Dose on the QT Interval in Healthy Female and Male Subjects.

https://clinicaltrials.gov/study/NCT02170987

COMPLETED

To investigate if dabigatran has a clinically relevant impact on the cardiac electrophysiology that is manifest as prolongation in QT-interval.

NO

Healthy

DRUG: Dabigatran etexilate low|DRUG: Dabigatran etexilate high|DRUG: Moxifloxacin|DRUG: Placebo

Change from baseline in mean time-matched QTc Interval, at 1.5, 2, and 3 hours following administration

Mean of the QTcI values of all ECGs, from 1 to 6 hours following administration|Change from baseline of the QTcI, from 1 to 24 hours following administration

Boehringer Ingelheim

ALL

ADULT, OLDER_ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE|Primary Purpose: TREATMENT

1160.54

2006-03

2006-05

2014-06-23

2014-06-23

{ "Dabigatran": [ { "intervention_type": "DRUG", "description": "Dabigatran etexilate low", "name": "Dabigatran", "synonyms": [ "Dabigatran", "Dabigatran Etexilate Mesylate", "N-((2-(((4-(aminoiminomethyl)phenyl)amino)methyl)-1-methyl-1H-benzimidazol-5-yl)carbonyl)-N-2-pyridinyl-beta-alanine", "Prazaxa", "Etexilate Mesylate, Dabigatran", "Mesylate, Dabigatran Etexilate", "Pradaxa", "BIBR 1048", "Pradax", "Dabigatran Etexilate", "Etexilate, Dabigatran", "Dabigatran etexilate" ], "medline_plus_id": "a610024", "generic_names": [ "Dabigatran", "Dabigatran etexilate" ], "nhs_url": "https://www.nhs.uk/medicines/dabigatran", "mesh_id": "D000991", "drugbank_id": "DB14726", "wikipedia_url": "https://en.wikipedia.org/wiki/Dabigatran" }, { "intervention_type": "DRUG", "description": "Dabigatran etexilate high", "name": "Dabigatran", "synonyms": [ "Dabigatran", "Dabigatran Etexilate Mesylate", "N-((2-(((4-(aminoiminomethyl)phenyl)amino)methyl)-1-methyl-1H-benzimidazol-5-yl)carbonyl)-N-2-pyridinyl-beta-alanine", "Prazaxa", "Etexilate Mesylate, Dabigatran", "Mesylate, Dabigatran Etexilate", "Pradaxa", "BIBR 1048", "Pradax", "Dabigatran Etexilate", "Etexilate, Dabigatran", "Dabigatran etexilate" ], "medline_plus_id": "a610024", "generic_names": [ "Dabigatran", "Dabigatran etexilate" ], "nhs_url": "https://www.nhs.uk/medicines/dabigatran", "mesh_id": "D000991", "drugbank_id": "DB14726", "wikipedia_url": "https://en.wikipedia.org/wiki/Dabigatran" } ], "Moxifloxacin": [ { "intervention_type": "DRUG", "description": "Moxifloxacin", "name": "Moxifloxacin", "synonyms": [ "Izilox", "Avalox", "Moxifloxacin", "Actira", "Moxifloxacin Hydrochloride", "BAY 12 8039", "Moxifloxacino", "BAY-128039", "BAY 12-8039", "Avelox", "BAY128039", "Octegra", "1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-((4as,7as)-octahydro-6H-pyrrolo(3,4-b)pyridin-6-yl)-4-oxo-3-quinolinecarboxylic acid", "Proflox", "1-Cyclopropyl--7-(2,8-diazabicyclo(4.3.0)non-8-yl)-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid", "BAY-12-8039", "Moxeza", "BAY 128039" ], "medline_plus_id": "a605016", "generic_names": [ "Moxifloxacin" ], "mesh_id": "D059005", "drugbank_id": "DB00218" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT04271787

New Periodontal Classification

https://clinicaltrials.gov/study/NCT04271787

COMPLETED

A new classification system of periodontal and peri-implant diseases and conditions was proposed by consensus of world experts in 2017. Since then there has been ongoing debates among periodontists regarding the application of the new classification. This study aims to shed light on the current understanding of the new classification among Egyptian periodontists.

NO

Periodontal Diseases|Peri-Implantitis|Gingival Diseases

OTHER: questionnaire

significant predictors of satisfaction with the new classification., Binary logistic Regression analysis to determine significant predictors of new classification application. Ordinal Regression analysis to determine significant predictors of satisfaction with the new classification., 4 months

Beni-Suef University

Cairo University

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

FDBSUREC/27022019/AM

2019-03-01

2019-06-30

2019-11-04

2020-02-17

2020-02-17

Maha Abdelkawy, Phd, Cairo, 62511, Egypt

{ "questionnaire": [ { "intervention_type": "OTHER" } ] }

NCT03932487

The Relationship Between Urine Iodine, Urine Bisphenol A and Autoimmune Thyroid Disease in Reproductive Women

https://clinicaltrials.gov/study/NCT03932487

UNKNOWN

Autoimmune thyroid disease (AITD) is the main cause of hypothyroidism in reproduction women, iodine and bisphenol A are the environmental factors for AITD. The research was mainly designed to investigate the effect of iodine and BPA on AITD in reproduction women to provide new evidence for hypothyroidism in reproduction women.

NO

The Effect of Iodine and BPA on AITD in Reproduction Women

OTHER: urinary iodine and urine BPA

Comparison of urinary iodine levels between the two groups, Urinary iodine levels were compared between patients with autoimmune thyroid disease and normal women., 2019-2011|Comparison of urinary BPA levels between the two groups, Urinary BPA levels were compared between patients with autoimmune thyroid disease and normal women., 2019-2011

Influencing factors of autoimmune thyroid diseases., Abnormal levels of iodine and PBA are influential factors in autoimmune thyroid disease., 2019-2012

Xiaomei Zhang

FEMALE

ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

Peking UIH

2019-06-24

2022-10-01

2022-10-01

2019-04-30

2020-03-06

Peking University international hospital, Beijing, Beijing, 102206, China

{ "Bisphenol A": [ { "intervention_type": "OTHER", "description": "urinary iodine and urine BPA", "name": "Bisphenol A", "synonyms": [ "Dianin's compound", "Bisphenol-A", "Bisphenol A", "4,4'-Isopropylidenediphenol", "BPA", "4,4'-Bisphenol A" ], "drugbank_id": "DB06973", "generic_names": [ "Bisphenol A" ] } ] }

NCT00829387

Cognitive Behavioral Therapy for Diabetic Neuropathic Pain

https://clinicaltrials.gov/study/NCT00829387

COMPLETED

The purpose of this study is to evaluate the efficacy of a brief psychological intervention, cognitive-behavior therapy, for the management of persistent pain associated with diabetic peripheral neuropathic pain.

YES

Diabetic Peripheral Neuropathic Pain

BEHAVIORAL: CBT plus standard pharmaceutical care (CBT/SC)|BEHAVIORAL: Diabetic Education plus standard pharmaceutical care (ED/SC)

Numeric Rating Scale (NRS) Pain Intensity, Primary outcome is the estimated mean change in pain intensity ratings from baseline to 12 weeks post-baseline comparing CBT and Educational arms Average pain intensity rating over the last 7 days; 0 (no pain at all) to 10 (worst pain imaginable). The higher the score, the more perceived pain a participant reported., baseline to 12 weeks post-baseline [post-treatment]|Numeric Rating Scale (NRS) Pain Intensity, Primary outcome is the estimated mean change in pain intensity ratings from baseline to 36 weeks post-baseline comparing CBT and Educational arms Average pain intensity rating over the last 7 days; 0 (no pain at all) to 10 (worst pain imaginable); the higher the number, the greater percieved pain intensity., baseline to 36 weeks post-baseline [follow-up]

The Interference Subscale of the Multidimensional Pain Inventory (MPI), Secondary outcome is the estimated mean change in pain interference from baseline to 12 weeks post-baseline comparing CBT to Education. Pain Interference at the time of assessment; 0 = no interference to 6 = extreme interference. The higher the average number calculated for the subscale, the higher the perceived interference pain has on vocational, social/recreational, and family/martital functioning., baseline to 12 weeks post-baseline [post-treatment]|Beck Depression Inventory (BDI), Estimated mean change in depressive symptoms from baseline to 12 weeks post-baseline combaring CBT and ED. 0 (do not endorse) to 3 (highly endorse). no/minimal depressive symptoms =<10; mild-moderate depressive symptoms = 10-18; moderate-severe depressive symptoms = 19-29 severe depressive symptoms = 30-63. The higher the score, the more depressive symptoms endorsed., baseline to 12 weeks post-baseline [post-treatment]|The Interference Subscale of the Multidimensional Pain Inventory (MPI), Secondary outcome is the estimated mean change in pain interference from baseline to 36 weeks post-baseline comparing CBT to Education. Pain Interference at the time of assessment; 0 = no interference to 6 = extreme interference. The higher the average number calculated for the subscale, the higher the perceived interference pain has on vocational, social/recreational, and family/martital functioning., baseline to 36 weeks post-baseline [follow-up]|Beck Depression Inventory (BDI), Estimated mean change in depressive symptoms from baseline to 36 weeks post-baseline comparing CBT to Education. 0 (do not endorse) to 3 (highly endorse). no/minimal depressive symptoms =<10; mild-moderate depressive symptoms = 10-18; moderate-severe depressive symptoms = 19-29 severe depressive symptoms = 30-63. The higher the score, the more depressive symptoms endorsed, baseline to 36 weeks post-baseline [follow-up]

VA Connecticut Healthcare System

ALL

ADULT, OLDER_ADULT

FED

INTERVENTIONAL

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

B6044R|RK0035

2010-03

2013-12

2013-12

2009-01-27

2015-06-18

2015-06-18

VA Connecticut Healthcare System, West Haven, Connecticut, 06516, United States|VA Connecticute Health Care System, West Haven, Connecticut, 06516, United States

{ "CBT plus standard pharmaceutical care (CBT/SC)": [ { "intervention_type": "BEHAVIORAL" } ], "Diabetic Education plus standard pharmaceutical care (ED/SC)": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT00002287

A Study of Retrovir in the Prevention of HIV Infection in Health Care Workers Accidentally Exposed to the Virus

https://clinicaltrials.gov/study/NCT00002287

COMPLETED

To evaluate the safety and effectiveness of Retrovir (AZT) when used as prophylaxis for health care workers at risk for HIV infection from exposure to HIV-contaminated blood or blood components.

NO

HIV Infections

DRUG: Zidovudine

Glaxo Wellcome

ALL

CHILD, ADULT, OLDER_ADULT

INDUSTRY

INTERVENTIONAL

Allocation: |Intervention Model: |Masking: |Primary Purpose: TREATMENT

014I|20

2001-08-31

2005-06-24

Glaxo Wellcome Inc, Research Triangle Park, North Carolina, 27709, United States

{ "Zidovudine": [ { "intervention_type": "DRUG", "description": "Zidovudine", "name": "Zidovudine", "synonyms": [ "Azidothymidine", "ZDV", "3' Azido 2',3' Dideoxythymidine", "AZT, Antiviral", "Zidovudine", "BW A509U", "Antiviral AZT", "3'-Azido-2',3'-Dideoxythymidine", "BWA509U", "3'-Azido-3'-deoxythymidine", "Zidovudina", "AZT", "BWA-509U", "AZT Antiviral", "BWA 509U", "Zidovudinum", "Retrovir", "AZT (Antiviral)", "3' Azido 3' deoxythymidine" ], "medline_plus_id": "a601168", "generic_names": [ "Zidovudine" ], "mesh_id": "D019380", "drugbank_id": "DB00495" } ] }

NCT04266587

ACTH Stability on Whole Blood

https://clinicaltrials.gov/study/NCT04266587

STABACT

UNKNOWN

ACTH is a peptide secreted by pituitary gland and plays an important role in regulating cortisol secretion. ACTH is determined in plasma by immunoassays using specific antibodies. Its determination is difficult because of instability in whole blood. Several factors which influence ACTH stability in blood before analysis have been identified: temperature, hemolysis, time to centrifugation and presence of protease inhibitors. Published results on ACTH whole blood stability seem contradictory. The objective of this study is to evaluate the effect of aprotinin in 10 healthy volunteers. ACTH measurements will be performed on cobas e602 (Roche Diagnostics, Mannheim, Germany).

NO

ACTH

BIOLOGICAL: Blood sampling

ACTH concentration in plasma, 8 hours

University Hospital, Rouen

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

2019/0350/HP

2020-07

2020-11

2020-11

2020-02-12

2020-06-29

Rouen University Hospital, Rouen, France

{ "Blood sampling": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT05751187

Pembrolizumab Plus Bevacizumab and Chemotherapy for Non-Squamous NSCLC Patients

https://clinicaltrials.gov/study/NCT05751187

RECRUITING

This study is designed to evaluate the efficacy and safety of Pembrolizumab in combination with Bevacizumab and chemotherapy in advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutation.

NO

Non-squamous NSCLC

BIOLOGICAL: Pembrolizumab|BIOLOGICAL: Bevacizumab|DRUG: Pemetrexed|DRUG: Cisplatin|DRUG: Carboplatin|DIETARY_SUPPLEMENT: Folic acid 350-1000 μg|DIETARY_SUPPLEMENT: Vitamin B12 1000 μg|DRUG: Dexamethasone 4 mg

Overall Response Rate (ORR), ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1)., Up to approximately 24 months

Progression-Free Survival (PFS), PFS is defined as the time from the first dose of study treatment to the first documented progressive disease (PD) per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on blinded independent central review (BICR), or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of ≥1 new lesion was also considered PD., Up to approximately 24 months|Overall Survival (OS), OS was defined as the time from the first dose of study treatment to death due to any cause., Up to approximately 24 months|Duration of Response (DOR), For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from the first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR with confirmation. The DOR per RECIST 1.1 for all participants who experienced a confirmed CR or PR is presented., From time of first documented evidence of CR or PR to Up to approximately 24 months|Number of Participants Who Experienced an Adverse Event (AE), An AE was defined as any untoward medical occurrence in a participant-administered study treatment that did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE is presented., Up to approximately 24 months|Number of Participants Who Discontinued Any Study Drug Due to an AE, The number of participants who discontinued any randomized study drug due to an AE is presented., Up to approximately 24 months

Shanghai Chest Hospital

Merck Sharp & Dohme LLC

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

IS22087

2023-06-27

2026-03-30

2027-03-30

2023-03-02

2023-07-12

Shanghai Chest Hospital, Shanghai, China

{ "Pembrolizumab": [ { "intervention_type": "BIOLOGICAL", "description": "Pembrolizumab", "name": "Pembrolizumab", "synonyms": [ "Keytruda", "Lambrolizumab", "Pembrolizumab" ], "medline_plus_id": "a614048", "generic_names": [ "Pembrolizumab" ], "drugbank_id": "DB09037", "wikipedia_url": "https://en.wikipedia.org/wiki/Pembrolizumab" } ], "Bevacizumab": [ { "intervention_type": "BIOLOGICAL", "description": "Bevacizumab", "name": "Bevacizumab", "synonyms": [ "Bevacizumab", "Bevacizumab awwb", "bevacizumab-awwb", "rhuMAb-VEGF", "Zirabev", "Avastin", "Anti-VEGF monoclonal antibody", "Bevacizumab-awwb", "Mvasi", "Anti-VEGF Humanized Monoclonal Antibody" ], "medline_plus_id": "a607001", "generic_names": [ "Bevacizumab" ], "mesh_id": "D000074322", "drugbank_id": "DB00112", "wikipedia_url": "https://en.wikipedia.org/wiki/Bevacizumab" } ], "Pemetrexed": [ { "intervention_type": "DRUG", "description": "Pemetrexed", "name": "Pemetrexed", "synonyms": [ "LY-231,514", "Pemetrexed", "LY 231514", "LY231514", "LY-231514", "Alimta", "231,514, LY", "Disodium, Pemetrexed", "LY 231,514", "MTA", "Pemetrexed Disodium", "231514, LY", "N-(4-(2-(2-amino-3,4-dihydro-4-oxo-7H-pyrrolo(2,3-d)pyrimdin-5-yl)ethyl)benzoyl)glutamic acid", "5-Methylthioadenosine", "5'-Deoxy-5'-(methylthio)adenosine", "S-Methyl-5'-thioadenosine", "Methylthioadenosine", "5'-S-methyl-5'-thioadenosine", "Thiomethyladenosine", "9-(5-S-methyl-5-thio-\u03b2-D-ribofuranosyl)-9H-purin-6-amine", "MTA", "5'-Methylthioadenosine" ], "medline_plus_id": "a607043", "generic_names": [ "Pemetrexed", "5'-S-methyl-5'-thioadenosine" ], "mesh_id": "D019384", "drugbank_id": "DB00642" } ], "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" } ], "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" } ], "Folic Acid": [ { "intervention_type": "DIETARY_SUPPLEMENT", "description": "Folic acid 350-1000 \u03bcg", "name": "Folic Acid", "synonyms": [ "Folic Acid", "Folicet", "Folvite", "Folicet", "Folate", "Folvite", "Folicet", "Folate" ], "medline_plus_id": "a682591", "generic_names": [ "Folic Acid" ] } ], "Vitamin B12 1000 \u03bcg": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ], "Dexamethasone": [ { "intervention_type": "DRUG", "description": "Dexamethasone 4 mg", "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" } ] }

NCT03691987

The Comeback Study

https://clinicaltrials.gov/study/NCT03691987

COMPLETED

This is a single-center stratified (on gender and donor), block randomized, placebo-controlled, parallel group trial with 12-months follow-up of 80 chronic fatigue syndrome/encephalomyelitis (CFS/ME) participants. Participants will be randomized to treatment by preprocessed thawed donor fecal microbiota transplant or preprocessed thawed autologous fecal microbiota transplant. Primary endpoint is the efficacy of FMT at three months by the Fatigue Severity Scale. The investigators will use patient reported outcomes for primary and secondary outcome measures. Previous studies suggest that a dysbiosis of the gut microbiota may be a key feature in CFS/ME. We hypothesize that A: CFS/ME is caused by a dysbiosis in the gut flora causing barrier leakage of bacterial products, a low grade systemic immune activation and disturbances in the host energy metabolism. B: Recovery of a normal gut flora by fecal microbiota transplantation (FMT) alleviates symptoms and may even induce remission of CFS/ME. This project aims to determine if there is a true cause and effect relationship between a dysbiotic gut flora and CFS/ME by testing if treatment of the observed dysbiosis by FMT also can resolve CFS/ME symptoms. In this process, collection of blood, fecal, and urine samples before and after FMT will open the possibility to explore the relationship between the gut flora, immune response, host energy metabolism and CFS/ME using technologies of microbiomics, metabolomics and immunological characterizations for a better understanding of the pathobiology of CFS/ME.

NO

Chronic Fatigue Syndrome|Myalgic Encephalomyelitis

BIOLOGICAL: Preprocessed thawed donor FMT|BIOLOGICAL: Preprocessed thawed autologous FMT

Proportion with treatment success in FSS score in donor versus placebo FMT group. Treatment success is defined as an improvement of more than 1.2 points on the Fatigue Severity Scale (FSS), Fatigue Severity Scale (FSS) is a self-reported, 9-item fatigue scale. Participants rate all 9 items on a 7-point Likert scale (1-2-3-4-5-6-7) depending on how appropriate they felt the statement applied to them over the preceding week. The total score is calculated by adding up the answer from each item and divide by 9. Lower scores indicate better outcomes. Maximum score is 7. In an intention to treat analysis we will categorize participants as responders/non-responders, defining responders as decrease of more than 1,2 to the total baseline score in the FSS at 3 months post FMT by Chi Square. Baseline score will be the average of the two scores from the screening period. Missing values will be regarded as non responders, Three months after treatment

Change in donor versus placebo FMT group in fatigue by the Fatigue Severity Scale score, Change in Fatigue severity scale by repeated measures from baseline and until 1, 3, 6, 9 and 12 months after treatment|Change in donor versus placebo FMT group in quality of life by the SF36 score, The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability., Change in SF36 score by repeated measures from baseline and until 3 and 12 months after treamtent|Change in donor versus placebo FMT group in neurocognitive function by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score from baseline and until 3 months after treatment., RBANS is a neuropsychological assessment that consists of ten subtests which give scores to five domains: Immediate memory, visuospatial/constructional ability, language, attention and delayed memory., Change from baseline and until three months after treatment|Change in donor versus placebo FMT group in anxiety and depression by the Hospital Anxiety Depression Scale (HADS) score, HADS is an instrument with 14-items for detection of depression and anxiety in hospitalized patients. Scores range from 1-21 interpreted as: normal (0-7), mild (8-10), moderate (11-14), severe (15-21). Subscales for anxiety (HADS-A) and depression (HADS-D) is also defined. We will explore the FMT effects on HADS by an independent sample T-test (or, if necessary, non-parametric Mann-Whitney) comparing change in global score. We will apply last value forward for missing values., Change in HADS score by repeated measures from baseline and until 3 and 12 months after treatment|Change in donor versus placebo FMT group in gastrointestinal related complaints by the sum score of selected items in the DePaul Questionnaire (DPQ) (29, 30, 46 and 47), The DPQ assesses key symptoms of ME/CFS such as fatigue, gastrointestinal complaints, post-exertional malaise, sleep, pain, neurological/cognitive impairments and autonomic, neuroendocrine and immune symptoms. At each item, participants have to rate the frequency and severity of the symptom on a scale from 0 to 4. We wil use the sum score from the questions that assess gastrointestinal complaints in the DPQ in this endpoint. This endpoint was implemented after 19 out of 80 participants had completed the three months follow up, Change in DPQ score by repeated measures from baseline and until 6 and 12 months after treatment|Number of Participants with Adverse Events as a Measure of Safety and Tolerability, Participants will be screened for adverse events from the time of informed consent through the end of the trial. In case of an identified adverse event, this will be recorded and described in the CRF, Baseline to end of follow up at 12 months after FMT|Change in HRV in donor FMT vs placebo FMT group derived from the R-R intervals in continuous ECG recordings. The primary vagal function outcome will be differences in changes from pre-post treatment between groups in High Frequency HRV (HF-HRV; in ms2, Firstbeat Bodyguard will record R-R interval and the Firstbeat life style assessment software will analyze the R-R interval recording and provide the outcome measure, 3 months after treatment|Change in HRV in donor FMT vs placebo FMT group derived from the R-R intervals in the resting continuous ECG recordings. The secondary vagal function outcome will be differences in changes from pre-post treatment between groups in RMSSD (RMSSD; in ms2), 3 months after treatment|Difference in mean baseline HRV (HF-HRV and RMSSD) between responders vs non-responders to donor FMT., As defined by the primary endpoint in the clinical study, a responder will be defined as an improvement of more than 1.2 points on the Fatigue Severity Scale (FSS) from baseline and until 3 months after treatment. To determine HRV in each group we will use High Frequency Power analysis denominating HRV in ms2., 3 months after treatment

Engraftment of donor microbiota, Comparison between baseline profile, post FMT and donor profile will show if engraftment of donor mikrobiota parallels clinical response to active FMT. To assess fecal gut microbiota composition, morning stool samples will be obtained at baseline and three and twelve months after FMT. Participants will collect their first morning bowel movement in a 120ml container for storing in their home freezer (-20C). Two-four weeks after, samples will be collected from participants home and stored on dry ice during transport until freezing at -80°C at the University Hospital of North Norway Harstad. Fecal analysis will be done by NextSeq500 allowing for enhanced metagenomics (prokaryote and viral) sequencing., 3 months after FMT|Engraftment of donor microbiota, Comparison between baseline profile, post FMT and donor profile will show if engraftment of donor microbiota parallels clinical response to active FMT. To assess fecal gut microbiota composition, morning stool samples will be obtained at baseline and three and twelve months after FMT. Participants will collect their first morning bowel movement in a 120ml container for storing in their home freezer (-20C). Two-four weeks after, samples will be collected from participants home and stored on dry ice during transport until freezing at -80°C at the University Hospital of North Norway Harstad. Fecal analysis will be done by NextSeq500 allowing for enhanced metagenomics (prokaryote and viral) sequencing., 12 months after FMT|Difference in metagenomic profile between responders and non responder to FMT, To assess fecal gut microbiota composition, morning stool samples will be obtained at baseline and three and twelve months after FMT. Participants will collect their first morning bowel movement in a 120ml container for storing in their home freezer (-20C). Two-four weeks after, samples will be collected from participants home and stored on dry ice during transport until freezing at -80°C at the University Hospital of North Norway Harstad. Fecal analysis will be done by NextSeq500 allowing for enhanced metagenomics (prokaryote and viral) sequencing., Baseline samples before FMT|Change in the nature of host immune and antibody response, Analysis (multipex technology) of mediators in the innate and adaptive immune response, Change from baseline to 3 months and difference between responders and non-responders to treatment at 3 months|Change in the nature of host immune and antibody response, Analysis (multipex technology) of mediators in the innate and adaptive immune response, Change from baseline to 12 months and difference between responders and non-responders to treatment at 12 months|Difference in the nature of host immune and antibody response between responders and non responders to FMT, Analysis (multipex technology) of mediators in the innate and adaptive immune response, Baseline samples before FMT|Change in the metabolome in feces, blood and urine, Analysis (mass spectrometry) on fecal extracts, urine and serum in order to assess the functional output of the microbiota, Change from baseline to 3 months and difference between responders and non-responders to treatment at 3 months|Change in biomarkers for breach in gut epithelium (sLPS-binding protein and sCD14) before and after transplantation, Analysis (ELISA) of immunological markers associated with gut barrier leak (sCD14 and sLPS-BP), Change from baseline to 3 months and difference between responders and non-responders to treatment at 3 months|Change in biomarkers for breach in gut epithelium (sLPS-binding protein and sCD14) before and after transplantation, Analysis (ELISA) of immunological markers associated with gut barrier leak (sCD14 and sLPS-BP), Change from baseline to 12 months and difference between responders and non-responders to treatment at 12 months|Difference in biomarkers for breach in gut epithelium (sLPS-binding protein and sCD14) in responders and non responders to FMT, Analysis (ELISA) of immunological markers associated with gut barrier leak (sCD14 and sLPS-BP), Baseline samples before FMT

University Hospital of North Norway

The Research Council of Norway|Quadram Institute Bioscience|Umeå University|Cornell University

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

2018/180

2019-02-15

2023-03-01

2023-12-31

2018-10-02

2024-02-23

University Hospital of North Norway, Harstad, Harstad, Troms, 9406, Norway

{ "Preprocessed thawed donor FMT": [ { "intervention_type": "BIOLOGICAL" } ], "Preprocessed thawed autologous FMT": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT02603887

Pembrolizumab in Treating Patients With Intermediate or High-Risk Smoldering Multiple Myeloma

https://clinicaltrials.gov/study/NCT02603887

ACTIVE_NOT_RECRUITING

This pilot early phase I trial studies pembrolizumab in treating patients with slow growing (smoldering) multiple myeloma with intermediate or high-risk of spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the bodys immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

YES

Smoldering Plasma Cell Myeloma

OTHER: Laboratory Biomarker Analysis|BIOLOGICAL: Pembrolizumab

Overall Response Rate (ORR), Overall response rate is defined as patients who have achieved partial response or higher as described per IMWG criteria for multiple myeloma after 8 cycles of therapy with pembrolizumab. Will be measured according to International Myeloma Working Group Criteria (IMWG) criteria. Response rate will be estimated accordingly. Each cycle has a duration of 21 days., From cycle 1 to cycle 8, up to 168 days

Number of Participants That Had Progression to Multiple Myeloma, Progressive disease assessed by IMWG criteria for multiple myeloma after 8 cycles of therapy with pembrolizumab., At 30 months from study entry|Clinical Benefit Rate, Minor response or better assessed by IMWG criteria for multiple myeloma after 8 cycles of therapy with pembrolizumab, From cycle 1 to cycle 8, up to 168 days|Overall Survival, Participants in a study or treatment group who are still alive for a certain period of time after they were diagnosed with or started treatment for a disease, Time of start of treatment to death from any cause up to 2 years and 6 months