| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| Targeting a Genomic Biomarker for PET Imaging and Staging of Urothelial Cancer: A Preliminary Evaluation [NCT03039413] | Early Phase 1 | 20 participants (Actual) | Interventional | 2016-09-28 | Active, not recruiting |
| Copper Antimicrobial Research Program: Environmental and Patient Sampling For Indicator Organisms To Determine The Efficacy Of Copper To Reduce Acquisition Of Microbes From The Patient Care Environment [NCT01565798] | | 614 participants (Actual) | Interventional | 2010-07-31 | Completed |
| Intrauterine Contraception for Adolescents Aged 14 to 18: A Multi-center Randomized Controlled Feasibility Trial of Levonorgestrel-releasing Intrauterine System Compared to the Copper T 380A [NCT00653159] | Phase 4 | 23 participants (Actual) | Interventional | 2007-07-31 | Completed |
| Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Patients With Treatment-Refractory Sarcomas [NCT05210374] | Phase 1 | 24 participants (Anticipated) | Interventional | 2023-03-09 | Recruiting |
| An Innovative Approach to Understanding and Controlling Transmission of HAIs [NCT02627092] | | 424 participants (Anticipated) | Interventional | 2016-01-31 | Active, not recruiting |
| A Phase II, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Disulfiram and Copper Gluconate When Added to Standard Temozolomide Treatment in Patients With Newly Diagnosed Resected Unmethylated Glioblastoma Multiforme [NCT03363659] | Phase 2 | 15 participants (Actual) | Interventional | 2018-03-28 | Terminated(stopped due to Investigator decision) |
| A Post-Marketing, Prospective, Multi-Center, Single Arm, Open Label Clinical Study to Evaluate the Safety of a New Inserter Design for Paragard® T380A Intrauterine Copper Contraceptive [NCT05309694] | Phase 4 | 119 participants (Actual) | Interventional | 2022-03-04 | Completed |
| Patient Compliance With Long-Acting Reversible Contraception Administration Immediately and Early Postpartum Versus Interval Postpartum [NCT03305081] | | 45 participants (Actual) | Interventional | 2014-10-22 | Terminated |
| Phase 1 Open Label Study of Zinc Therapy in ALS Patients [NCT01259050] | Phase 1/Phase 2 | 10 participants (Anticipated) | Interventional | 2010-10-31 | Completed |
| Comparative Study of Intrauterine Contraceptive Device Insertion During Caesarean Section Versus Conventional Application [NCT02674139] | Phase 4 | 8 participants (Anticipated) | Interventional | 2016-02-29 | Enrolling by invitation |
| Imaging of Solid Tumors Using FAP-2286 [NCT04621435] | Phase 1 | 116 participants (Anticipated) | Interventional | 2020-12-14 | Recruiting |
| Short Course Radiotherapy Based Total Neoadjuvant Therapy With or Without Chlorophyllin (SCOTCH Study) [NCT05856305] | Phase 2 | 76 participants (Anticipated) | Interventional | 2023-07-05 | Recruiting |
| Phase I Study of Disulfiram and Copper Gluconate for the Treatment of Refractory Solid Tumors Involving the Liver [NCT00742911] | Phase 1 | 21 participants (Actual) | Interventional | 2008-07-31 | Completed |
| Early Copper Histidine Therapy in Menkes Disease [NCT00001262] | Phase 1/Phase 2 | 60 participants (Actual) | Interventional | 1990-06-30 | Completed |
| Immediate Versus Delayed Insertion of the Copper IUD After Second-trimester Medical Abortion - a Randomised Controlled Trial. [NCT03505047] | | 110 participants (Actual) | Interventional | 2018-05-10 | Completed |
| Molecular Bases of Response to Copper Treatment in Menkes Disease, Related Phenotypes, and Unexplained Copper Deficiency [NCT00811785] | Phase 3 | 93 participants (Actual) | Interventional | 2009-02-27 | Completed |
| A Pilot Study of 64Cu-DOTA-Trastuzumab Positron Emission Tomography in Treatment of Advanced HER2 Positive Breast Cancer With the Antibody Drug Conjugate Ado-trastuzumab Emtansine [NCT02226276] | | 10 participants (Actual) | Interventional | 2015-01-07 | Active, not recruiting |
| The Effect of 30mcg and Levonorgestrel 150 Combined Oral Contraceptive, Etonogestrel-releasing Subdermal Implant and Levonorgestrel-releasing Intrauterine System on Breast-Milk Production and Infant Growth in Fully Breast-Feeding Women [NCT01388582] | Phase 4 | 40 participants (Actual) | Interventional | 2011-04-30 | Completed |
| Immediate vs. Delayed Post-abortal Copper T 380A IUD Insertion in Cases Over 12 Weeks of Gestation [NCT00540046] | | 215 participants (Actual) | Interventional | 2007-04-30 | Completed |
| Comparison of Wound Healing Efficacy Between MedCu Wound Dressings With Copper Oxide and Negative Pressure Wound Therapy (NPWT/VAC) Treatment [NCT05215730] | | 46 participants (Actual) | Interventional | 2021-07-07 | Completed |
| Preventing Future Pregnancy After Choosing the Copper IUD vs. Oral Levonorgestrel for Emergency Contraception [NCT00966771] | | 548 participants (Actual) | Observational | 2009-10-31 | Completed |
| A Pilot Study- Prevention of Capecitabine Induced Hand and Foot Syndrome [NCT01291628] | | 10 participants (Anticipated) | Interventional | 2012-01-31 | Not yet recruiting |
| A Phase II, Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety, Tolerability, and Efficacy of DIsulfiram and Copper Gluconate in Recurrent Glioblastoma [NCT03034135] | Phase 2 | 23 participants (Actual) | Interventional | 2017-03-09 | Completed |
| An Open-Label, Randomized Study to Determine the Safety and Efficacy of LUXSOL(TM) Cream for the Treatment of Bacterial Vaginosis: A Proof of Concept Study [NCT02197182] | Early Phase 1 | 50 participants (Actual) | Interventional | 2014-06-30 | Terminated(stopped due to Not for safety reasons) |
| A Randomized Trial of Immediate Versus Delayed Insertion of the Copper T380A Following Medication Abortion [NCT00737178] | Phase 4 | 156 participants (Actual) | Interventional | 2008-07-31 | Completed |
| Peptide Receptor Radionuclide Therapy Administered to Participants With Meningioma With 67Cu-SARTATE™: A Single-centre, Open-label, Non- Randomised, Phase I-IIa Theranostic Clinical Trial [NCT03936426] | Phase 1/Phase 2 | 5 participants (Actual) | Interventional | 2018-07-09 | Completed |
| A Combination of Zinc, Chromium, Vitamin C, and Copper Supplement for Prediabetes Progression: Randomized Controlled-Trial in Jakarta [NCT04511468] | | 670 participants (Anticipated) | Interventional | 2021-06-23 | Recruiting |
| Pilot Efficacy Study of MedCu Wound Dressings With Copper Oxide in Treating Pressure Sores and Post-op Wounds [NCT04634838] | | 20 participants (Actual) | Interventional | 2021-02-02 | Terminated(stopped due to In view of the very positive results obtained with the copper dressings after 20 patients, the researchers decided to apply copper dressings from the beginning of wound management, not to use anymore silver dressings and to terminate the trial.) |
| This Study is a Small Preliminary Study to Evaluate the Possibility of Performing a Phase 1 Study. [NCT00846144] | | 100 participants (Anticipated) | Interventional | 2009-09-30 | Not yet recruiting |
| [NCT02679820] | | 500 participants (Actual) | Interventional | 2016-01-31 | Completed |
| A Pilot Study Of A Randomized Trial Comparing Two Different Time Frames For Copper T380A Intrauterine Contraception Insertion; Immediately Postpartum Compared To 4-6 Weeks Postpartum In Lilongwe, Malawi [NCT01175161] | | 115 participants (Actual) | Interventional | 2010-10-31 | Completed |
| Human Biomarkers for Assessing Copper Deficiency and Repletion: A Pilot Study [NCT01177579] | Phase 1 | 70 participants (Anticipated) | Interventional | 2010-11-30 | Recruiting |
| The Safety and Efficacy of Immediate Post Placental IUD Insertion Versus the Post Puerperal IUD Insertion in Patients Undergoing Cesarean Delivery [NCT04630548] | | 66 participants (Anticipated) | Interventional | 2020-12-01 | Not yet recruiting |
| Prospective Assessment of Acceptability and Adherence Associated With Use of the Copper Intrauterine Device (CuT380A-IUCD) Compared to Depo-medroxyprogesterone Acetate (DMPA) Among HIV Positive Women in Lilongwe, Malawi [NCT01191203] | | 200 participants (Actual) | Interventional | 2010-07-31 | Completed |
| An Open-Label, Multi-Center Expanded Access Protocol of Copper Cu 64 Dotatate for the Detection, Localization and Monitoring of Somatostatin Receptor Expressing Neuroendocrine Tumors (NETs) [NCT04334837] | | 0 participants | Expanded Access | | Approved for marketing |
| Assessment of the Diagnostic Value of 64Cu-SAR-BBN PET Imaging for Men With Negative PSMA PET in Prostate Cancer [NCT05613842] | Phase 2 | 30 participants (Actual) | Interventional | 2022-08-09 | Completed |
| Immediate Post Placental Insertion of Intrauterine Device at Cesarean Delivery, is Acceptable, Feasible and Safe in Iraqi Women. [NCT04136613] | | 150 participants (Actual) | Interventional | 2015-09-01 | Completed |
| Mucosal and Systemic Responses to Contraceptives in HIV-Infected Women in Zambia [NCT00807625] | Phase 2 | 66 participants (Actual) | Interventional | 2008-11-30 | Completed |
| A Multi Center, Open-Label, Randomised Clinical Trial Comparing HIV Incidence and Contraceptive Benefits in Women Using Depot Medroxyprogesterone Acetate (DMPA), Levonorgestrel (LNG) Implant, and Copper Intrauterine Devices (IUDs) [NCT02550067] | | 7,830 participants (Actual) | Interventional | 2015-12-14 | Completed |
| 64Cu-DOTA-trastuzumab Positron Emission Tomography in Patients With Gastric Cancer [NCT01939275] | | 8 participants (Actual) | Interventional | 2014-11-19 | Active, not recruiting |
| Imaging the HIV Reservoir [NCT03063788] | Phase 1 | 17 participants (Actual) | Interventional | 2018-09-18 | Completed |
| Efficiency of Using Copper-Nickel-Titanium Versus Nickel-Titanium Arch Wires on Anterior Segment Crowding Alleviation in Group of Adults With Moderate Crowding: A Randomized Controlled Clinical Trial [NCT04815200] | | 30 participants (Anticipated) | Interventional | 2021-03-18 | Recruiting |
| A Randomized, Single-blind, Trial of Tralement Versus a Fixed-dose Trace Element Combination Product of Zinc, Copper, and Selenious Acid to Evaluate Manganese Safety in Pediatric Patients Requiring Long-term Parenteral Nutrition [NCT05677126] | Phase 4 | 80 participants (Anticipated) | Interventional | 2023-09-30 | Not yet recruiting |
| A Randomized, Single-blind, Trial of Tralement Versus a Fixed-dose Trace Element Combination Product of Zinc, Copper, and Selenious Acid to Evaluate Manganese Safety in Adult Patients Requiring Long-term Parenteral Nutrition [NCT05661682] | Phase 4 | 108 participants (Anticipated) | Interventional | 2023-09-30 | Not yet recruiting |
| A Phase II Pilot Study of Disulfiram and Copper Gluconate in Patients With Metastatic Pancreatic Cancer and Rising CA-19-9 Levels While Receiving Abraxane-Gemcitabine or FOLFIRINOX or Single-Agent Gemcitabine [NCT03714555] | Phase 2 | 1 participants (Actual) | Interventional | 2019-10-17 | Terminated(stopped due to Study was closed due to low subject enrollment at site.) |
| A Pilot Phase I Open Label Study of Cu-64-TP3805 PET Imaging for Detection of Prostate Cancer in Men Undergoing Radical Prostatectomy [NCT02603965] | Phase 1 | 25 participants (Actual) | Interventional | 2013-08-31 | Completed |
| Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs [NCT00461253] | | 25,565 participants (Actual) | Observational | 2006-10-31 | Completed |
| A Non-interventional Study to Observe the Bleeding Pattern of LNG-IUS Inserted Immediately After Surgical Abortion Compared With Copper IUD [NCT01958684] | | 512 participants (Actual) | Observational | 2013-10-31 | Completed |
| Use of 64Cu-DOTA-Trastuzumab PET Imaging and Molecular Markers for Prediction of Response to Trastuzumab and Pertuzum-Based Neoadjuvant Therapy [NCT02827877] | Phase 2 | 18 participants (Actual) | Interventional | 2016-07-15 | Active, not recruiting |
| Effectiveness of Early Versus Standard Insertion of Post Abortion Intrauterine Contraception After First Trimester Medical Management of Incomplete Abortion in Central Uganda: A Non-Inferiority Randomized Clinical Trial [NCT05343546] | | 2,076 participants (Anticipated) | Interventional | 2022-06-30 | Not yet recruiting |
| A First-in-Human, Phase I/II PET Imaging Study of 64Cu-GRIP B, a Radiotracer Targeting Granzyme B, in Patients With Advanced Malignancies [NCT05888532] | Phase 1/Phase 2 | 91 participants (Anticipated) | Interventional | 2023-05-25 | Recruiting |
| Study of the VeraCept Intrauterine Device for Long Acting Reversible Contraception [NCT02167763] | Phase 1 | 300 participants (Anticipated) | Interventional | 2013-11-30 | Completed |
| DIRECT (DIsulfiram REsponse as add-on to ChemoTherapy in Recurrent) Glioblastoma: A Randomized Controlled Trial [NCT02678975] | Phase 2/Phase 3 | 88 participants (Actual) | Interventional | 2017-01-31 | Completed |
| Comparison of Levonorgestrel Intrauterine System, Copper T Intrauterine Device and Oral Contraceptives on Life Quality [NCT01805817] | Phase 4 | 0 participants (Actual) | Interventional | 2012-12-31 | Withdrawn |
| Impact of Intrauterine Contraception on the Immune Environment of the Female Genital Tract [NCT01240811] | | 42 participants (Actual) | Interventional | 2010-11-30 | Completed |
| Insertion of an IUD After Medical Abortion [NCT00621543] | | 120 participants (Actual) | Interventional | 2006-03-31 | Completed |
| [NCT00608946] | Phase 2 | 68 participants (Actual) | Interventional | 2004-03-31 | Completed |
| A Pilot Study of Copper T380A IUDs Versus Oral Levonorgestrel for Emergency Contraception [NCT00669396] | | 57 participants (Actual) | Interventional | 2008-04-30 | Completed |
| Transcesarean IUD Insertion: A Prospective Cohort Study [NCT01439802] | Phase 4 | 90 participants (Actual) | Interventional | 2008-08-31 | Completed |
| New Method of IUD Insertion During Cesarian Section [NCT05756998] | | 156 participants (Anticipated) | Interventional | 2022-02-02 | Recruiting |
| 64Cu-DOTA-B-Fab as A PET Tracer for Evaluating CA6 Expression in Tumors: A First in Human Study [NCT02708511] | Phase 1 | 2 participants (Actual) | Interventional | 2016-08-31 | Terminated |
| Acceptability and Technical Feasibility of Insertion of a Copper IUD at Time of Elective C-section: A Pilot Study [NCT00733278] | Phase 4 | 7 participants (Actual) | Interventional | 2007-11-30 | Completed |
| DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users. [NCT01731132] | | 207 participants (Actual) | Observational | 2012-07-31 | Completed |
| Comparative of Two Devices (Conventional Intrauterine Devices (Cu T380 A)/Frameless Intrauterine Devices (GyneFix)) for Postpartum Immediate Contraception in Cesarean Deliveries [NCT02941198] | | 140 participants (Actual) | Interventional | 2016-06-01 | Completed |
| Postpartum Glucose Tolerance in Women With Recent Gestational Diabetes Using the Levonorgestrel IUD and Non-Hormonal Contraception: A Prospective Cohort Study [NCT01022645] | | 42 participants (Actual) | Observational | 2009-11-30 | Completed |
| A Pharmacodynamic Study of Proteasome Inhibition by Disulfiram in Patients With Glioblastoma [NCT01907165] | Early Phase 1 | 21 participants (Actual) | Interventional | 2013-10-10 | Completed |
| Phase II Study of Vinorelbine, Cisplatin, Disulfiram and Copper in CTC_EMT Positive Refractory Metastatic Breast Cancer. [NCT04265274] | Phase 2 | 0 participants (Actual) | Interventional | 2020-01-01 | Withdrawn(stopped due to Poor acrual) |
| A Phase I Study of 64Cu Pembrolizumab PET Imaging for In Vivo Expression of PD1 [NCT04605614] | Phase 1 | 0 participants (Actual) | Interventional | 2022-08-15 | Withdrawn(stopped due to slow accruals) |
| Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector [NCT01392157] | Phase 4 | 300 participants (Actual) | Interventional | 2011-06-30 | Completed |
| A Phase 1 Single and Multiple Dose Escalation and Pharmacokinetic Study of Cu(II)ATSM Administered Orally to Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease [NCT02870634] | Phase 1 | 50 participants (Anticipated) | Interventional | 2016-11-16 | Completed |
| The Effect of a Levonorgestrel-releasing Intrauterine Device Versus a Copper Containing Intrauterine Device on Coagulation Parameters [NCT00584610] | | 50 participants (Anticipated) | Interventional | 2007-12-31 | Recruiting |
| A Prospective Trial of the Copper T380 IUD or Oral Levonorgestrel and the Levonorgestrel IUD Initiated With Emergency Contraception [NCT01963962] | | 188 participants (Actual) | Observational | 2013-07-31 | Completed |
| PET Imaging of Breast Cancer Using Oncogene Expression [NCT02810873] | | 19 participants (Actual) | Interventional | 2008-09-30 | Terminated(stopped due to Study terminated by PI) |
| Zinc and Biobehavioral Development in Early Childhood [NCT00589264] | | 251 participants (Actual) | Interventional | 2004-07-31 | Completed |
| 64 Cu-DOTA-Trastuzumab Positron Emission Tomography in Women With Advanced HER2 Positive Invasive Breast Cancer [NCT01093612] | | 18 participants (Actual) | Interventional | 2011-03-16 | Active, not recruiting |
| A Randomized Trial of IUD Versus Hormonal Contraception in HIV-infected Women in Zambia [NCT00336245] | Phase 3 | 600 participants | Interventional | 2002-06-30 | Completed |
| A Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Complete Study CMD-2019-001 [NCT04313166] | Phase 2 | 55 participants (Actual) | Interventional | 2020-03-19 | Completed |
| Prospective Multicentre Non-interventional Comparative Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction [NCT01590537] | | 2,348 participants (Actual) | Observational | 2011-09-30 | Completed |
| Metallic Nanoparticles: Evaluation of Their Antibacterial, Antibiofilm and Synergistic Effect in Combination With Antibiotics on Nosocomial Bacteria [NCT04775238] | | 100 participants (Anticipated) | Interventional | 2021-02-27 | Recruiting |
| Use of 64Cu-DOTA-Alendronate PET Imaging for Localization and Characterization of Breast Calcifications [NCT03542695] | Early Phase 1 | 1 participants (Actual) | Interventional | 2021-11-03 | Active, not recruiting |
| Evaluation of Non-B Non-C Liver Cirrhosis in A EL-Rajhi Assuit University Hospital: A Retrospective-Prospective Study [NCT05314270] | | 100 participants (Anticipated) | Observational | 2022-10-01 | Not yet recruiting |
| Satisfaction, Continuity, and Bleeding Patterns in Patients With Breast Cancer Using Copper and Silver Intrauterine Device (IUD) Compared to Copper IUD: a Randomized Clinical Trial [NCT05148910] | | 90 participants (Anticipated) | Interventional | 2020-08-06 | Recruiting |
| A Phase I Study of Disulfiram and Copper Gluconate in Patients With Treatment-Refractory Multiple Myeloma [NCT04521335] | Phase 1 | 2 participants (Actual) | Interventional | 2021-05-21 | Terminated(stopped due to Closed at PI's Request) |
| A Phase Ib Study of Intravenous Copper Loading With Oral Disulfiram in Metastatic, Castration Resistant Prostate Cancer [NCT02963051] | Phase 1 | 9 participants (Actual) | Interventional | 2017-07-11 | Terminated(stopped due to Study stopped due to lack of efficacy.) |
| Pilot Study: Imaging Tumor Extent and Response Before and After Neoadjuvant Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer Using 64Cu-Labeled M5A Antibody to Carcinoembryonic Antigen (CEA) [NCT05245786] | Early Phase 1 | 15 participants (Anticipated) | Interventional | 2022-08-31 | Recruiting |
| Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors [NCT06016855] | Phase 4 | 6 participants (Anticipated) | Interventional | 2023-09-01 | Not yet recruiting |
| Copper Histidinate Treatment for Menkes Disease [NCT04074512] | | 0 participants | Expanded Access | | Available |
| Randomised Controlled Trial on the Effect of Copper Impregnated Dressings and Maternity Pads on the Healing of Obstetric Wounds and Wound Infection [NCT03284749] | | 774 participants (Actual) | Interventional | 2016-01-14 | Completed |
| RAPID EC - Randomized Controlled Trial Assessing Pregnancy With Intrauterine Devices for Emergency Contraception [NCT02175030] | Phase 4 | 711 participants (Actual) | Interventional | 2016-08-31 | Completed |
| 67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk Neuroblastoma: A Multi-center, Dose-escalation, Open-label, Non-randomized, Phase 1-2a Theranostic Clinical Trial [NCT04023331] | Phase 1/Phase 2 | 34 participants (Anticipated) | Interventional | 2020-08-18 | Recruiting |
| A PHASE II CLINICAL TRIAL FOR THE EVALUATION OF THE EFFICACY OF DISULFIRAM/COPPER COMBINATION AS AN ADJUVANT AND CONCURRENT CHEMOTHERAPY IN THE TREATMENT OF NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORM [NCT01777919] | Phase 2 | 32 participants (Anticipated) | Interventional | 2017-01-31 | Not yet recruiting |
| Safe Maternity Care Through Immediate Provision of Highly-effective Postpartum Contraception [NCT03389958] | | 299 participants (Actual) | Observational | 2015-10-01 | Completed |
| A Phase I/II Dose-escalation and Dose-expansion Study of Disulfiram/Copper With Concurrent Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma [NCT02715609] | Phase 1/Phase 2 | 35 participants (Actual) | Interventional | 2016-06-15 | Active, not recruiting |
| Pilot Trial Using 64Cu-DOTA Pembrolizumab (64CDP) in Patients Receiving Stereotactic Body Radiation Therapy for Oligo-Progressive Solid Tumors [NCT05728372] | Early Phase 1 | 0 participants (Actual) | Interventional | 2023-08-25 | Withdrawn(stopped due to withdrawn per PI) |
| A Phase II Study to Evaluate Oral Chlorophyllin in Hemorrhagic Cystitis Secondary to Radiation Therapy for Pelvic Malignancies [NCT05348239] | Phase 2 | 24 participants (Anticipated) | Interventional | 2022-03-26 | Recruiting |
| Effect of Copper Impregnated Textiles on Healthcare Associated Infections and Antibiotic Use in a Single Intensive Care Unit [NCT02351895] | | 1,302 participants (Actual) | Observational | 2014-01-31 | Completed |
| Safety and Efficacy Study of MedCu Wound Dressings With Copper Oxide [NCT04963998] | | 13 participants (Actual) | Interventional | 2019-10-02 | Completed |
| A Pilot Phase I Open Label Study of Cu-64-TP3805 PET Imaging for Detection of Prostate Cancer in Men With Persistently Elevated PSA [NCT02989623] | | 20 participants (Actual) | Interventional | 2015-09-01 | Completed |
| Role for Biochemical Assays and Kayser-Fleischer Rings in Diagnosis of Wilson Disease [NCT04965545] | | 1,000 participants (Anticipated) | Observational | 2004-01-01 | Recruiting |
| Copper Use as Protection Against Antimicrobial Resistance in the ICU [NCT04873557] | | 168 participants (Actual) | Interventional | 2020-11-02 | Completed |
| (TRIBE) Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users [NCT02311478] | | 79 participants (Actual) | Interventional | 2014-12-31 | Completed |
| Clinical Profile and Out Come of Children With Wilson's Disease :A Single Tertiary Center Study . [NCT05792319] | | 20 participants (Anticipated) | Observational | 2023-12-20 | Not yet recruiting |
| Correlation Between Uterine Artery Doppler Indices and Menstrual Changes After Insertion of Copper Intrauterine Contraceptive Device and Levonorgestrel Intrauterine System [NCT05986344] | | 165 participants (Anticipated) | Observational | 2023-08-30 | Not yet recruiting |
| Rates of Contraceptive Failure When Unprotected Intercourse Has Occurred 6-14 Days Prior to Contraceptive Initiation [NCT02076217] | | 1,030 participants (Anticipated) | Observational | 2014-02-28 | Active, not recruiting |
| Micronutrient Status Involved in Immunity in Elderly Patients With COVID-19 [NCT04877509] | | 229 participants (Actual) | Observational | 2020-03-01 | Completed |
| A Phase 1 Dose Escalation Study of Cu(II)ATSM Administered Orally to Patients With Early Idiopathic Parkinson's Disease [NCT03204929] | Phase 1 | 31 participants (Actual) | Interventional | 2017-08-14 | Completed |
| ArchWire-RaCE: Orthodontic Archwires: a Randomised Clinical Trial of Effectiveness [NCT02659813] | | 64 participants (Actual) | Interventional | 2016-10-31 | Completed |
| Comparison of Two IUDs Among Cape Town HIV-positive Women: A Randomized Controlled Trial Assessing Safety of Registered Products in South Africa [NCT01721798] | | 205 participants (Actual) | Interventional | 2013-11-10 | Completed |
| Efficacy of Copper in Reducing Health-Acquired Infections and Microbial Burden as Measured on High Touch Surfaces in a Pediatric Intensive Care Unit. A Controlled Clinical Trial. [NCT01678612] | | 1,012 participants (Actual) | Interventional | 2012-11-30 | Completed |
| SmartWire Multiforce Archwire Clinical Trial [NCT02983084] | | 105 participants (Anticipated) | Interventional | 2016-12-01 | Active, not recruiting |
| Somatostatin Receptor Imaging Study of Estrogen Receptor Positive (ER+) Metastatic Breast Cancer [NCT05880394] | Phase 1 | 30 participants (Anticipated) | Interventional | 2023-01-10 | Active, not recruiting |
| Particle-based Partial Tumor Irradiation Targeting Hypoxic Segment and Sparing the Peritumoral Immune Microenvironment for Unresectable Bulky Tumors [NCT04875871] | | 22 participants (Anticipated) | Interventional | 2021-11-11 | Recruiting |
| Impact of Copper Compression Stockings on Venous Insufficiency and Lipodermatosclerosis: a Randomised Controlled Trial [NCT03283800] | | 16 participants (Actual) | Interventional | 2015-09-23 | Completed |
| Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk [NCT02357368] | Phase 4 | 59 participants (Actual) | Interventional | 2015-02-28 | Completed |
| The UMPALA Study: A Clinical Study to Assess the Impact of Contraceptives on the Cervico-Vaginal Mucosa [NCT04814927] | Phase 4 | 112 participants (Actual) | Interventional | 2021-03-01 | Completed |
| A Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Completed Study CMD-2016-001 [NCT03136809] | Phase 1/Phase 2 | 28 participants (Actual) | Interventional | 2018-01-18 | Active, not recruiting |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Somatic Growth Percentiles at 3 Years of Age (or at Age of Death) - Length Percentile
(NCT00001262)
Timeframe: 36 months or death
| Intervention | Other - Percentile (Mean) |
|---|
| Early | 8.286 |
| Late | 15.455 |
| Mild | 28.333 |
Somatic Growth Percentiles at 3 Years of Age (or at Age of Death) - Weight Percentile
(NCT00001262)
Timeframe: 36 months or death
| Intervention | Other - Percentile (Mean) |
|---|
| Early | 12.086 |
| Late | 11.273 |
| Mild | 5.000 |
Fine Motor Adaptive Development at 36 Mos of Age or at Death (Mos)
This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate fine motor development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age. (NCT00001262)
Timeframe: 36 months or death
| Intervention | Other - Months (Mean) |
|---|
| Early | 16.200 |
| Late | 2.409 |
| Mild | 17.667 |
Gross Motor Development at 36 Mos of Age or at Death (Mos)
This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate gross motor development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age. (NCT00001262)
Timeframe: 36 months or death
| Intervention | Other - months (Mean) |
|---|
| Early | 13.743 |
| Late | 2.455 |
| Mild | 15.667 |
Language Development at 36 Mos of Age or at Death (Mos)
This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate language development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age. (NCT00001262)
Timeframe: 36 months or death
| Intervention | Other - Months (Mean) |
|---|
| Early | 15.800 |
| Late | 3.227 |
| Mild | 21.000 |
Personal-Social Development at 36 Mos of Age or at Death (Mos)
This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate personal-social development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age. (NCT00001262)
Timeframe: 36 months or death
| Intervention | Other - Months (Mean) |
|---|
| Early | 17.657 |
| Late | 3.364 |
| Mild | 17.667 |
Somatic Growth Percentiles at 3 Years of Age (or at Age of Death) - Head Circumference Percentile
(NCT00001262)
Timeframe: 36 months or death
| Intervention | Other - Percentile (Mean) |
|---|
| Early | 33.286 |
| Late | 11.136 |
| Mild | 18.333 |
Breast Cancer Risk
Breast cancer (invasive carcinoma or carcinoma in situ) in women aged <50 years at diagnosis. Cases were excluded if they had died before study start or had a history of malignancy. (NCT00461253)
Timeframe: retrospective, January 2000 to December 2007
| Intervention | participants (Number) |
|---|
| LNG IUD | 1076 |
| Cu-IUD | 1068 |
Use of IUD
Number of participants using Copper T380A IUD 6 months after surgery (NCT00540046)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| A/Immediate | 58 |
| B/Delayed | 25 |
Expulsion
IUD was not removed by provider but fell out on its own. (NCT00540046)
Timeframe: 6 months
| Intervention | percentage of expulsions (Number) |
|---|
| A/Immediate | 3.1 |
| B/Delayed | 0 |
Percentage of Women Continuing IUD Use at 3 Months
(NCT00621543)
Timeframe: 3 months
| Intervention | percentage of participants (Mean) |
|---|
| Single Arm Study | 80. |
Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion.
(NCT00621543)
Timeframe: Three months
| Intervention | percentage of participants (Mean) |
|---|
| Single Arm Study | 4 |
Expulsion Rates
Rates of partial or complete expulsion for teens randomized to the LNG-IUS or Copper T 380A. Patients experiencing partial expulsion had IUDs visible on speculum exam. Complete expulsion is characterized by complete evacuation of the IUD. (NCT00653159)
Timeframe: 6 months
| Intervention | percentage of randomized subjects (Number) |
|---|
| Paragard IUD [CuT380A] | 18 |
| Mirena IUD [LNG-IUS] | 0 |
Heavy Bleeding Rates
Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A. (NCT00653159)
Timeframe: 6 months
| Intervention | percentage of randomized subjects (Number) |
|---|
| Paragard IUD [CuT380A] | 55 |
| Mirena IUD [LNG-IUS] | 33 |
Pregnancy Rates
Proportion of subjects who became pregnant within 6 months of IUD insertion (NCT00653159)
Timeframe: 6 months
| Intervention | percentage of randomized subjects (Number) |
|---|
| Paragard IUD [CuT380A] | 9 |
| Mirena IUD [LNG-IUS] | 0 |
Retention Rate
Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up) (NCT00653159)
Timeframe: 6 months
| Intervention | percentage of randomized subjects (Number) |
|---|
| Paragard IUD [CuT380A] | 55 |
| Mirena IUD [LNG-IUS] | 75 |
Device Satisfaction Rates
"Satisfaction rate is the proportion of subjects who report being happy or very happy with their assigned intrauterine contraceptive method on the date of their 6 month study visit." (NCT00653159)
Timeframe: 6 months
| Intervention | percentage of subjects completing study (Number) |
|---|
| Paragard IUD [CuT380A] | 80 |
| Mirena IUD [LNG-IUS] | 70 |
Infection
diagnosis and treatment for pelvic inflammatory disease (NCT00669396)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Copper T380 IUD | 0 |
| Levonorgestrel | 0 |
Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception
Use of a method of contraception with a typical efficacy rate >= to 92%. This includes combined hormonal contraception (combined oral contraceptive pills, the contraceptive patch and ring), sterilization, IUDs, Depo-provera, and contraceptive implants. (NCT00669396)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Copper T380 IUD | 9 |
| Levonorgestrel | 13 |
Pregnancy
positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception. (NCT00669396)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Copper T380 IUD | 0 |
| Levonorgestrel | 2 |
IUD Expulsion, Removal, or Perforation
patient reports IUD expulsion, removal, or perforation OR one of these events was documented at the clinic where patient received care. (NCT00669396)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Copper T380 IUD | 5 |
| Levonorgestrel | 0 |
Successful Retention of IUD
(NCT00733278)
Timeframe: 6 weeks
| Intervention | participants (Number) |
|---|
| IUD Placement | 7 |
Visibility Within the Vagina of IUD Strings at All Times.
(NCT00733278)
Timeframe: At 3 days, 2 weeks and 6 weeks postpartum
| Intervention | participants (Number) |
|---|
| IUD Strings | 7 |
Insertion Rates
Insertion rates are the proportion of women in each allocation group (immediate, delayed) who ultimately had the IUD inserted within the 6 month study period. (NCT00737178)
Timeframe: By six months after medication abortion
| Intervention | participants (Number) |
|---|
| Immediate IUD Insertion | 69 |
| Delayed IUD Insertion | 65 |
Use of the IUD for Contraception at Six Months
Six months after enrollment, we determined whether or not women were using the IUD through in-person exit interviews and phone interviews. This was an intention to treat analysis, comparing the proportion of women using the IUD based on their group assignment (immediate or delayed). (NCT00737178)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Immediate IUD Insertion | 49 |
| Delayed IUD Insertion | 51 |
Expulsion and Removal Rates
"Expulsion rates were defined as the number of IUDs expelled from the uterus among participants who had the IUD inserted during the study.~Removal rates were defined as the number of IUDs that were electively removed by participant request among participants who had the IUD inserted during the study." (NCT00737178)
Timeframe: Within six months of medication abortion
| Intervention | participants (Number) |
|---|
| Expulsions | Removals |
|---|
| Delayed IUD Insertion | 7 | 5 |
,| Immediate IUD Insertion | 8 | 10 |
Tumor Uptake of 64Cu-DOTA-trastuzumab After 24 Hours
"Comparison of uptake between the HER2+ and HER2- groups, treating SUVmax measurements for individual tumors as independent observations. Statistical significance of differences in SUVmax between patient groups was assessed via a nonparametric (Wilcoxon rank-sum) test.~Radiolabel uptake for tumors was measured in terms of single-voxel maximum SUV (SUVmax; SUV = tissue activity per mL x body weight [g]/injected activity decay-corrected to time of scan)." (NCT01093612)
Timeframe: 24 hours after injection of 64 CU-DOTA-trastuzumab
| Intervention | SUVmax (g/mL) (Median) |
|---|
| HER2+ Patients | 7.0 |
| HER2- Patients | 3.7 |
Tumor Uptake of 64Cu-DOTA-trastuzumab After 48 Hours
"Comparison of uptake between the HER2+ and HER2- groups, treating SUVmax measurements for individual tumors as independent observations. Statistical significance of differences in SUVmax between patient groups was assessed via a nonparametric (Wilcoxon rank-sum) test.~Radiolabel uptake for tumors was measured in terms of single-voxel maximum SUV (SUVmax; SUV = tissue activity per mL x body weight [g]/injected activity decay-corrected to time of scan)." (NCT01093612)
Timeframe: 48 hours after injection of 64 CU-DOTA-trastuzumab
| Intervention | SUVmax (g/mL) (Median) |
|---|
| HER2+ Patients | 8.7 |
| HER2- Patients | 4.6 |
Change in Quantities of Vaginal H2O2-producing Lactobacillus Species and Gardnerella Vaginalis
Changes in vaginal flora as assessed by qPCR quantitation of H2O2 producing Lactobacilli species and Gardnerella vaginalis. Quantitative PCR (qPCR) results are reported as log concentration of gene copies/swab specimen. (NCT01240811)
Timeframe: 2 Months
| Intervention | log gene copies/swab (Median) |
|---|
| Change in log Lactobacilli quantity | Change in log Garnerella vaginalis quantity |
|---|
| Control-No IUD | -0.6 | 0 |
,| Copper T380A IUD | 0.1 | 0 |
,| Levonorgestrel IUS | -0.1 | 0 |
Change in Vaginal Flora
Changes in vaginal flora as assessed by Nugent score The Nugent score is calculated by microscopically assessing for the presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0 to 4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0 to 4), and curved Gram-variable rods (Mobiluncus spp. morphotypes; scored as 0 to 2) and can range from 0 to 10. A score of 7 to 10 is consistent with bacterial vaginosis, 4-6 is consistent with intermediate vaginal flora, and 0-3 is normal vaginal flora. (NCT01240811)
Timeframe: 2 Months
| Intervention | units on a scale (Median) |
|---|
| Control-No IUD | 0 |
| Levonorgestrel IUS | 1 |
| Copper T380A IUD | 0 |
%CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium
Change in CCR5 expression on T-lymphocytes 2 months after insertion of IUD (either hormonal LNG-IUD or non-hormonal Cu-IUD) in cervix and endometrium as measured by flow cytomety (NCT01240811)
Timeframe: 2 months
| Intervention | % of T-cells expressing CCR5 (Mean) |
|---|
| Control-No IUD | 4.9 |
| Levonorgestrel IUS | 11.7 |
| Copper T380A IUD | 7.2 |
Number of Participants With Expulsion of IUD
Number of participants with Expulsion of IUDs placed at time of cesarean delivery. (NCT01439802)
Timeframe: 6 week postpartum
| Intervention | Participants (Count of Participants) |
|---|
| IUD Maintained | IUD Expelled |
|---|
| Postplacental Insertion of Intrauterine Device (IUD) | 54 | 0 |
Number of Participants With Expulsion of IUD
Number of participants with Expulsion of IUDs placed at time of cesarean delivery. (NCT01439802)
Timeframe: 6 months postpartum
| Intervention | Participants (Count of Participants) |
|---|
| IUD Maintained | IUD Expelled |
|---|
| Postplacental Insertion of Intrauterine Device (IUD) | 42 | 0 |
Satisfaction of IUD Placement
"Satisfaction of subjects who received an IUD at time of cesarean delivery was measured based on a telephone survey administered 6 months postpartum. A 4-point Likert scale (Very Happy/Happy, Somewhat Happy, Unsure, Unhappy) was used to evaluate participants' attitude toward the IUD." (NCT01439802)
Timeframe: 6 months postpartum
| Intervention | Participants (Count of Participants) |
|---|
| Very Happy/Happy | Somewhat Happy | Unsure | Unhappy |
|---|
| Postplacental Insertion of Intrauterine Device (IUD) | 34 | 4 | 4 | 0 |
Number of HER2 Negative, Positive, or Equivocal Participants With Either Negative or Positive Tumor Readings
"The reading of the 64CuDOTA-trastuzumab-PET imaging of the study subjects were performed by two radiologists, one who read the first scan and the second nuclear radiologist read the remaining seven scans. To eliminate potential bias, the second nuclear radiologist was blinded to the HER2 status of the tumors as well as the location of the tumor until radiolabeled uptake was measured. XD (version 3.6; Miranda Medical) was used for image analysis.Tumor visualized as hot relative to adjacent tissue reported per radiologist as negative, positive, equivocal or unknown." (NCT01939275)
Timeframe: Up to 1 year
| Intervention | participants (Number) |
|---|
| HER2 Negative, Tumor Visual Negative | HER 2 Positive, Tumor Visual Negative | HER 2 Equivocal, Tumor Visual Negative | HER2 Negative, Tumor Visual Positive | HER 2 Positive, Tumor Visual Positive | HER 2 Equivocal, Tumor Visual Positive |
|---|
| Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan) | 5 | 1 | 2 | 0 | 0 | 0 |
Number of Participants With Unintended Pregnancy After Initiating the Levonorgestrel IUD Versus the Copper T380 IUD for EC at One Year.
Participants will be followed for pregnancies at regular intervals throughout the year and pregnancies will be recorded. (NCT02175030)
Timeframe: 1 year after enrollment
| Intervention | Participants (Count of Participants) |
|---|
| Copper T380 IUD | 7 |
| LNG20 IUD | 7 |
Percentage of Participants Reporting a Pregnancy
Urine pregnancy tests within 30 days after IUD insertion will be performed either at home or in clinic. We will use the total number of pregnancies per ARM and the overall number of participants analyzed per ARM to calculate, for each ARM, the percentage of participants reporting a pregnancy in the first month of use of the IUD. (NCT02175030)
Timeframe: 1 month after enrollment
| Intervention | % of participants reporting pregnancy (Number) |
|---|
| Copper T380 IUD | 0 |
| LNG20 IUD | 0.3 |
Relationship Between Tumor Minimum Uptake of Copper Cu 64-DOTA-trastuzumab as Measured by PET and Patient Best Response
Relationship between patient best response to T-DM1 and measured tumor uptake of 64Cu-DOTA-trastuzumab employed a t-test with a 0.05 two-sided significance level comparing minimum uptake in responsive vs non-responsive patients. Tumor uptake measured as SUV defined as SUV = AC(tsc) Wb /[Dinj exp(-λ(tsc - tinj)] , where AC(tsc) is the activity concentration in the volume of interest (VOI, e. g., a tumor), Wb is the patient's body weight, Dinj is the activity injected at time tinj, and λ is the decay constant for the injected radioisotope. AC(tsc) is determined from the spatial density of counts acquired from the VOI. Tumor uptake was measured in terms of minimum voxel standardized uptake value, SUVmin. Response assessment adhered to Positron Emission Tomography (PET) Response Criteria in Solid Tumors (PERCIST 1.0). (NCT02226276)
Timeframe: Up to 1 year
| Intervention | SUVmin (g/mL) (Median) |
|---|
| Diagnostic (Copper Cu 64-DOTA-trastuzumab PET) | 5.1 |
Relationship Between Average Tumor Uptake of Copper Cu 64-DOTA-trastuzumab as Measured by PET and Patient Best Response
Relationship between patient best response to T-DM1 and measured tumor uptake of 64Cu-DOTA-trastuzumab employed a t-test with a 0.05 two-sided significance level comparing average uptake in responsive vs non-responsive patients. Tumor uptake measured as SUV defined as SUV = AC(tsc) Wb /[Dinj exp(-λ(tsc - tinj)] , where AC(tsc) is the activity concentration in the volume of interest (VOI, e. g., a tumor), Wb is the patient's body weight, Dinj is the activity injected at time tinj, and λ is the decay constant for the injected radioisotope. AC(tsc) is determined from the spatial density of counts acquired from the VOI. Tumor uptake was measured in terms of maximum voxel standardized uptake value, SUVmax. Response assessment adhered to Positron Emission Tomography (PET) Response Criteria in Solid Tumors (PERCIST 1.0). (NCT02226276)
Timeframe: Baseline
| Intervention | SUVmax (g/mL) (Median) |
|---|
| Diagnostic (Copper Cu 64-DOTA-trastuzumab PET) | 3.1 |
Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Sexual Functioning and Satisfaction
# of individuals reporting that their new method had neutral or positive impact of their new contraceptive on their sex life across time points. (NCT02311478)
Timeframe: 6 months
| Intervention | percentage of participants (Number) |
|---|
| T380A Copper IUD | 80 |
Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Method Satisfaction and Continuation at 6 Months Post Insertion.
Determine rates of continuation and level of satisfaction with the IUD during the first 6 months of use. (NCT02311478)
Timeframe: 6-month post insertion
| Intervention | percent of patients (Number) |
|---|
| satisfied | continuing |
|---|
| T380A Copper IUD | 51.6 | 6.4 |
Evaluate Changes in Bleeding Duration Among Women Initiating the Copper T380 IUD During the 90 Days Prior to Initiation Compared to Two 90 Periods After IUD Insertion.
Evaluate bleeding duration among women initiating the copper T380 IUD during the 90 days prior to initiation compared to two 90 periods after IUD insertion. Women will track bleeding after the insertion of the T380A IUD for 180 days. Participants will be contacted monthly to collect data. (NCT02311478)
Timeframe: 3 months prior to insertion, month 1-month 3 , month 4-month 6
| Intervention | days of bleeding (Mean) |
|---|
| 3 months prior to insertion | month 1-month3 | month 4-month 6 |
|---|
| T380A Copper IUD | 4.5 | 6.0 | 5.5 |
Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood
The concentration levels of interleukin 1 (IL-1) family cytokines and interferon gamma-induced protein 10 (IP-10) chemokines were determined using multiplex Luminex® assays combined with a customized multi-analytical panel of 22 human cytokines and chemokines. IL-1 and IP-10 have been found to influence recruitment of HIV target cells to the female reproductive tract and this study is examining changes in IL-1 and PI-10 to gain further understanding of these mechanisms. (NCT02357368)
Timeframe: Week 1, Week 17
| Intervention | pg/mL (Mean) |
|---|
| IP-10 Cervicovaginal Lavage (CVL) Week 1 | IP-10 CVL Week 17 | IP-10 Peripheral Blood Mononuclear Cell (PBMC) Week 1 | IP-10 PBMC Week 17 | IL-1a CVL Week 1 | IL-1a CVL Week 17 | IL-1a PBMC Week 1 | IL-1a PBMC Week 17 | IL-1b CVL Week 1 | IL-1b CVL Week 17 | IL-1b PBMC Week 1 | IL-1b PBMC Week 17 |
|---|
| Depot Medroxyprogesterone Acetate (DMPA) | 689.8 | 445.8 | 3298.5 | 3114.4 | 752.2 | 550.7 | 58.5 | 47.8 | 32.9 | 21.1 | 20.0 | 20.8 |
,| Etonogestrel Impant (Eng-Implant) | 2551.1 | 2417.6 | 4107.3 | 3954.3 | 1640.2 | 2120.6 | 156.2 | 144.1 | 583.4 | 485.8 | 51.4 | 46.5 |
,| Levonorgestrel Intrauterine Device (Lng-IUD) | 1100.2 | 1241.5 | 204.4 | 209.6 | 256.4 | 184.7 | 54.6 | 65.1 | 43.9 | 37.1 | 4.2 | 4.3 |
Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood
Following exposure to HIV, initial infection occurs at the genital mucosa and may involve complex interactions between a number of HIV target immune cells. HIV often uses C-C Chemokine Receptor Type 5 (CCR5) for entrance into target immune cells, causing infection of the cell. The amount of CCR5 expressing macrophages is associated with HIV infection. Cluster of differentiation 4 (CD4) T Cells are targeted and infected by HIV and CD4 percentages are used to assess immune status. CD4 counts vary by individuals and generally decrease with HIV infection. (NCT02357368)
Timeframe: Week 1, Week 17
| Intervention | percentage of HIV target immune cells (Mean) |
|---|
| CCR5+ CD4 T-cells Cervicovaginal Lavage (CVL) Week 1 | CCR5+ CD4 T-cells CVL Week 17 | CCR5+ CD4 T-cells Peripheral Blood Mononuclear Cell (PBMC) Week 1 | CCR5+ CD4 T-cells PBMC Week 17 | CD4% CVL Week 1 | CD4% CVL Week 17 | CD4% PBMC Week 1 | CD4% PBMC Week 17 |
|---|
| Depot Medroxyprogesterone Acetate (DMPA) | 26.6 | 39.2 | 4.1 | 5.7 | 47.2 | 47.4 | 65.6 | 63.9 |
,| Etonogestrel Impant (Eng-Implant) | 22.8 | 32.2 | 3.9 | 4.2 | 48.7 | 47.0 | 67.4 | 67.5 |
,| Levonorgestrel Intrauterine Device (Lng-IUD) | 16.9 | 23.3 | 2.9 | 2.6 | 54.0 | 48.8 | 65.7 | 63.4 |
,| ParaGard® T 380A Intrauterine Copper Contraceptive | 22.4 | 15.3 | 8.3 | 7.5 | 63.4 | 47.5 | 73.3 | 71.1 |
Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood
T cell activation correlates with HIV infection progression and this study seeks to gain better understanding of these underlying mechanisms by assessment of HIV target cells. Changes in cluster of differentiation 38 (CD38) expression are indicators of HIV disease progression with increases seen in CD38+ when a chronic HIV infection is progressing. Human leukocyte antigen-antigen D related (HLA-DR)+ expression appears to be involved in HIV proliferation. (NCT02357368)
Timeframe: Week 1, Week 17
| Intervention | percentage of T cell activation markers (Mean) |
|---|
| CD38+ CD4 T-cells Cervicovaginal Lavage (CVL) Week 1 | CD38+ CD4 T-cells CVL Week 17 | CD38+ CD4 T-cells Peripheral Blood Mononuclear Cell (PBMC) Week 1 | CD38+ CD4 T-cells PBMC Week 17 | HLA-DR+ CD4 T-cells CVL Week 1 | HLA-DR+ CD4 T-cells CVL Week 17 | HLA-DR+ CD4 T-cells PBMC Week 1 | HLA-DR+ CD4 T-cells PBMC Week 17 | CD38+ Target (CCR5+ CD4+) T cells CVL Week 1 | CD38+ Target (CCR5+ CD4+) T cells CVL Week 17 | CD38+ Target (CCR5+ CD4+) T cells PBMC Week 1 | CD38+ Target (CCR5+ CD4+) T cells PBMC Week 17 | HLA-DR+ Target (CCR5+ CD4+) T cells CVL Week 1 | HLA-DR+ Target (CCR5+ CD4+) T cells CVL Week 17 | HLA-DR+ Target (CCR5+ CD4+) T cells PBMC Week 1 | HLA-DR+ Target (CCR5+ CD4+) T cells PBMC Week 17 |
|---|
| Depot Medroxyprogesterone Acetate (DMPA) | 36.7 | 35.9 | 17.1 | 17.7 | 25.0 | 21.2 | 4.8 | 4.4 | 62.5 | 52.5 | 22.7 | 24.1 | 30.7 | 30.0 | 24.4 | 23.2 |
,| Etonogestrel Impant (Eng-Implant) | 36.9 | 41.7 | 17.6 | 17.6 | 26.9 | 17.8 | 3.0 | 2.3 | 64.5 | 61.6 | 26.0 | 29.6 | 41.3 | 25.5 | 22.6 | 21.6 |
,| Levonorgestrel Intrauterine Device (Lng-IUD) | 32.6 | 44.0 | 17.0 | 17.2 | 15.4 | 11.4 | 3.3 | 3.6 | 66.2 | 70.8 | 28.2 | 31.7 | 28.2 | 17.6 | 28.3 | 25.5 |
,| ParaGard® T 380A Intrauterine Copper Contraceptive | 23.2 | 45.5 | 25.2 | 36.3 | 8.7 | 21.1 | 3.4 | 2.5 | 12.7 | 42.4 | 18.6 | 30.9 | 20.1 | 26.5 | 16.5 | 10.1 |
Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood
CD4/CD8 ratios above 1 indicate a strong immune system while lower ratios indicate a viral infection. (NCT02357368)
Timeframe: Week 1, Week 17
| Intervention | CD4/CD8 (Mean) |
|---|
| CD4/CD8 Ratio Cervicovaginal Lavage (CVL) Week 1 | CD4/CD8 Ratio CVL Week 17 | CD4/CD8 Ratio Peripheral Blood Mononuclear Cell (PBMC) Week 1 | CD4/CD8 Ratio PBMC Week 17 |
|---|
| Depot Medroxyprogesterone Acetate (DMPA) | 2.4 | 2.6 | 4.3 | 2.6 |
,| Etonogestrel Impant (Eng-Implant) | 2.6 | 2.3 | 3.1 | 3.3 |
,| Levonorgestrel Intrauterine Device (Lng-IUD) | 2.9 | 2.3 | 2.9 | 2.5 |
,| ParaGard® T 380A Intrauterine Copper Contraceptive | 3.9 | 4.9 | 4.7 | 5.4 |
Number of F-18-FDG Positive Lesions That Are Detected by the Copper Cu 64 TP3805 Analog
Cu-64 results will be compared with those of F-18-FDG for: The unit of analysis will be the lesion (with potentially multiple lesions available per patient). (NCT02810873)
Timeframe: 4 hours after Cu 64 TP3805 administered
| Intervention | Number of Lesions (Number) |
|---|
| F-18-FDG Whole-body Scan | 10 |
| No F-18-FDG Scan | 14 |
SUV Measurement by 64Cu-DOTA Trastuzumab PET
"First Scan SUV Maximum, measurement by 64Cu-DOTA trastuzumab PET SUV is Standard Uptake Value. SUV = tumor activity concentration x patient body weight/injected activity decay-corrected to time of scan." (NCT02827877)
Timeframe: Baseline
| Intervention | SUV (Median) |
|---|
| Treatment (Trastuzumab, Copper Cu 64-DOTA-trastuzumab PET) | 6.6 |
Number of Participants With Serious Adverse Events
Number of Participants with Grade 3 and 4 serious adverse events (NCT03034135)
Timeframe: 14 months
| Intervention | Participants (Count of Participants) |
|---|
| DSF-Cu | 2 |
Overall Survival
Percentage of patients that are alive (NCT03034135)
Timeframe: 6 months and 12 months
| Intervention | percentage of participants (Number) |
|---|
| 6 months | 12 months |
|---|
| DSF-Cu | 61 | 35 |
Objective Response Rate
ORR will be defined as the percentage of patients with complete response (CR) or partial response (PR) according to the RANO criteria. (NCT03034135)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Complete response | Partial Response |
|---|
| DSF-Cu | 0 | 0 |
Progression Free Survival
Percentage of patients that are free from progressive disease per RANO criteria (NCT03034135)
Timeframe: 6 months
| Intervention | percentage of participants (Number) |
|---|
| DSF-Cu | 14 |
Number of Women With Placement of LARC
The outcome will be measured by the number of participants with LARC placement. The total number of women who expressed a desire to have postpartum contraception placed and randomized to the appropriate arm will be assessed. (NCT03305081)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Immediate or Early Placement | 10 |
| Interval Placement | 2 |
Patient Satisfaction With Method of LARC Using LARC Survey
"Number of patients satisfied with LARC obtained by LARC survey at 6-weeks, 12-weeks postpartum, and 6 months postpartum. Patients identify Yes/No response via telephone survey asking, Are you satisfied with this form of contraception?. Satisfaction determined if subject answers Yes. A single value was calculated at the end of the study by summation at all three time points." (NCT03305081)
Timeframe: 6 Weeks, 12 weeks postpartum, 6 months postpartum
| Intervention | Participants (Count of Participants) |
|---|
| Immediate or Early Placement | 10 |
| Interval Placement | 2 |
Overall Survival
Overall Survival will be assessed as a number of participants alive at 1 and 2 years. (NCT03363659)
Timeframe: 1 and 2 years
| Intervention | Participants (Count of Participants) |
|---|
| 1 Year | 2 Years |
|---|
| Open Label | 9 | 2 |
6 Months Progression Free Survival (PFS)
To determine 6 month PFS of patients with unmethylated glioblastoma treated with DSF-Cu in combination with concurrent radiation and temozolomide. This was assessed by the number of participants who did not have disease progression and were alive at 6 months. (NCT03363659)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Open Label | 1 |