PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT03233230: Phase IIb Study of Evobrutinib in Subjects With Rheumatoid Arthritis
Official title: A Phase IIb, Randomized, Double-blind Study in Subjects With Rheumatoid Arthritis Evaluating the Safety and Efficacy of Evobrutinib Compared With Placebo in Subjects With an Inadequate Response to Methotrexate
Conditions: Rheumatoid Arthritis
Summary: The purpose of this study was to determine the efficacy, dose response, and safety of M52951 in participants with Rheumatoid Arthritis (RA), and to consider a dose to took forward into Phase III development.
Interventions:
description: Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 12 weeks.
name: M2591 25 mg QD
other_name: Evobrutinib
type: Drug
description: Participants received 75 mg of M2951 orally QD for 12 weeks.
name: M2951 75 mg QD
other_name: Evobrutinib
type: Drug
description: Participants received 50 mg of M2951 orally twice daily (BID) for 12 weeks.
name: M2951 50 mg BID
other_name: Evobrutinib
type: Drug
description: Participants received placebo matched to M2951 orally for 12 weeks.
name: Placebo
type: Drug
Study arms:
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_title: M2951 25 mg QD
design_group_type: Experimental
design_group_title: M2951 75 mg QD
design_group_type: Experimental
design_group_title: M2951 50 mg BID
design_group_type: Experimental
Sponsor: EMD Serono Research & Development Institute, Inc.
Collaborators: Merck KGaA
Drug name mappings:
name: 埃沃布鲁替尼
lang: CN
name: Evobrutinib
lang: EN
Clinical trial NCT00357396: Busulfan, Melphalan, and Thiotepa Followed By a Donor Stem Cell Transplant in Treating Patients With High-Risk Ewing's Tumors
Official title: A Phase II Trial of a Chemotherapy Based Regimen of Intravenous Busulfan (Busulfex), Melphalan and Thiotepa as Myeloablative Regimen Followed by a T- Cell Depleted Allogeneic Hematopoietic Stem Cell Transplant From and HLA-Compatible Donor in the Treatment of High Risk Ewing's Sarcoma Family Tumors
Conditions: Sarcoma
Summary: RATIONALE: Giving chemotherapy drugs, such as busulfan, melphalan, and thiotepa, before a donor stem cell transplant helps stop the growth of tumor cells and prepares the patient's bone marrow for the stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal tissues. Giving tacrolimus, sirolimus, and mycophenolate mofetil may stop this from happening.
PURPOSE: This phase II trial is studying how well giving busulfan together with melphalan and thiotepa followed by a donor stem cell transplant works in treating patients with high-risk Ewing's tumors.
Interventions:
name: graft versus host disease prophylaxis/therapy
type: Biological
name: busulfan
type: Drug
name: melphalan
type: Drug
name: thiotepa
type: Drug
name: allogeneic bone marrow transplantation
type: Procedure
name: allogeneic hematopoietic stem cell transplantation
type: Procedure
name: peripheral blood stem cell transplantation
type: Procedure
Study arms:
design_group_description: * Myeloablative preparative regimen: Patients receive busulfan IV over 2 hours every 6 hours on days -8 to -6, melphalan IV over 20 minutes on days -5 to -3, and thiotepa IV over 4 hours on day -2.<br/>* Allogeneic hematopoietic stem cell transplant: Patients undergo allogeneic bone marrow or T-cell depleted peripheral blood stem cell transplantation on day 0.<br/>* Graft-vs-host disease (GVHD) prophylaxis: Patients receive treatment according to institutional guidelines and are given treatment against infection.<br/>After completion of study treatment, patients are followed periodically for at least 3 years.
design_group_title: Chemo followed by DSCT
design_group_type: Experimental
Sponsor: Memorial Sloan Kettering Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 白消安
lang: CN
name: Busulfan
lang: EN
name: ブスルファン
lang: JP
name: 美法仑
lang: CN
name: Melphalan
lang: EN
name: メルファラン
lang: JP
name: 塞替派
lang: CN
name: Thiotepa
lang: EN
name: チオテパ
lang: JP
Clinical trial NCT05635045: Evuzamitide in PET/CT to Measure Potential Therapeutic Response in ATTR
Official title: A Follow-Up Study to Monitor Therapeutic Response in Transthyretin Cardiac Amyloidosis Using Amyloid Reactive Peptide 124I-evuzamitide (AT01) PET/CT
Conditions: Transthyretin Amyloidosis
Summary: This was a single center, prospective cohort study that is evaluating the ability of 124I-evuzamitide PET scanning to detect potential therapeutic changes in subjects under treatment for ATTR after one year had elapsed since their original 124I-evuzamitide PET scan.
Ten previously scanned subjects re-consented to undergo another 124I-evuzamitide PET scan. Demographic, clinical and phenotypic data were collected to characterize potential changes since their previous scans.
Interventions:
description: Amyloid reactive protein used as imaging agent in whole body SPECT-CT imaging
name: I 124-Evuzamitide
other_name: Attralus AT-01
type: Drug
Study arms:
design_group_description: Subjects treated with tafamidis selected to re-scan to determine the change over time in Evuzamitide uptake
design_group_title: Stabilizer Only
design_group_type: Active Comparator
design_group_description: Subjects treated with vutrisiran selected to re-scan to determine the change over time in Evuzamitide uptake
design_group_title: Silencer Only
design_group_type: Active Comparator
design_group_description: Subjects treated with tafamidis and patisiran selected to re-scan to determine the change over time in Evuzamitide uptake
design_group_title: Stabilizer and Silencer (tafamidis + patisiran)
design_group_type: Active Comparator
design_group_description: Subjects treated with vutrisiran and diflunisal selected to re-scan to determine the change over time in Evuzamitide uptake
design_group_title: Stabilizer and Silencer (vutrisiran + diflunisal)
design_group_type: Active Comparator
Sponsor: Columbia University
Collaborators: Attralus, Inc.
Drug name mappings:
name: Iodine (124I) evuzamitide
lang: EN
Clinical trial NCT00418535: Clinical Study of Chemoradiation Followed by VIPD in Nasal Natural Killer (NK)/T-cell Lymphoma
Official title: A Phase II Study of Concurrent Chemoradiation Followed by VIPD (Etoposide/Ifosfamide/Cisplatin/Dexamethasone) in Stage I, II Nasal NK/T-cell Lymphoma
Conditions: Lymphoma, T-Cell
Summary: Nasal NK/T-cell lymphoma is a peculiar clinico-pathologic subtype of non-Hodgkin's lymphoma (NHL). Although most patients present with stage I/II, only 30-60% of the patients remain disease-free. The efficacy of the conventional anthracycline-based chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone [CHOPP]) has been unsatisfactory.
The optimal treatment of localized NK/T-cell lymphoma has not been defined yet. The optimal dose, sequence, and multi-modality treatment with involved field radiotherapy still need to be refined. This trial is to evaluate the efficacy of concurrent chemoradiotherapy with cisplatin followed by VIPD (etoposide, ifosfamide, cisplatin, dexamethasone) in localized NK/T-cell lymphoma patients.
Interventions:
name: Concurrent Radiotherapy (RT)/cisplatin, VIPD
type: Drug
Study arms:
Sponsor: Samsung Medical Center
Collaborators: Korea University Anam Hospital
Gyeongsang National University Hospital
Asan Medical Center
Drug name mappings:
name: 顺铂
lang: CN
name: Cisplatin
lang: EN
name: シスプラチン
lang: JP
Clinical trial NCT02647944: Pilot Study of the Effect of Liraglutide on Weight Loss and Gastric Functions in Obesity
Official title: Pilot Study of the Effect of Liraglutide on Weight Loss and Gastric Functions in Obesity
Conditions: Obesity
Summary: This study was being done to assess the stomach emptying effect of a maximum dose of 3 mg Liraglutide compared to placebo in subjects who are overweight or obese. Liraglutide is a medication approved by the Food and Drug Administration (FDA) for routine clinical use.
Interventions:
description: Initiate at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6mg/day in weekly intervals to a dose of 3.0 mg/day is achieved (<br/>4 weeks). Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
name: Liraglutide
other_name: Saxenda
type: Drug
name: Placebo
type: Drug
Study arms:
design_group_description: Saxenda initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
design_group_title: Liraglutide
design_group_type: Active Comparator
design_group_description: Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Mayo Clinic
Collaborators: National Institute of Diabetes & Digestive & Kidney Diseases
Novo Nordisk A/S
Drug name mappings:
name: 利拉鲁肽
lang: CN
name: Liraglutide
lang: EN
name: リラグルチド（遺伝子組換え）
lang: JP
Clinical trial NCT07426822: Rash & Diarrhea Prophylaxis With Capivasertib
Official title: A Phase II Trial to Improve Safety of Capivasertib for HR+/HER2- Metastatic Breast Cancer
Conditions: Metastatic HR+/HER2- Breast Cancer
Summary: This is a randomized, multicenter, phase II clinical trial evaluating prophylactic strategies to mitigate common toxicities associated with capivasertib in combination with fulvestrant in participants with hormone receptor-positive (HR+), HER2-negative advanced breast cancer who are eligible for this treatment regimen.
Interventions:
description: 400 mg orally, twice daily (BID), on 4-days-on/3-days-off schedule.
name: Capivasertib
type: Drug
description: 2 mg orally once daily on capivasertib dosing days
name: Loperamide
type: Drug
description: 500 mg Administered intramuscularly every 14 days for the first three injections and every 28 days thereafter.
name: Fulvestrant
type: Drug
description: 10 mg orally once a day, starting on Cycle 1 Day 1 and continued for the first eight weeks (each cycle=28 days)
name: Ceterizine
type: Drug
Study arms:
design_group_description: All participants will receive capivasertib + fulvestrant. Capivasertib will be administered at 400 mg orally, twice daily (BID), on 4-days-on/3-days-off schedule. Fulvestrant will be administered at 500 mg intramuscularly (IM) every 14 days for the first three injections, and every 28 days thereafter. Participants in this arm will take cetirizine 10 mg orally once daily, and loperamide 2 mg orally once daily on capivasertib dosing days, starting on Cycle 1 Day 1 and continued for the first eight weeks (each cycle = 28 days).
design_group_title: Rash and diarrhea prophylaxis
design_group_type: Experimental
design_group_description: All participants will receive capivasertib + fulvestrant. Capivasertib will be administered at 400 mg orally, twice daily (BID), on 4-days-on/3-days-off schedule. Fulvestrant will be administered at 500 mg intramuscularly (IM) every 14 days for the first three injections, and every 28 days thereafter. Participants will take cetirizine 10 mg orally once daily, starting on Cycle 1 Day 1 and continued for the first eight weeks (each cycle = 28 days).
design_group_title: Rash prophylaxis
design_group_type: Experimental
Sponsor: Yale University
Collaborators: AstraZeneca PLC
Drug name mappings:
name: 盐酸西替利嗪
lang: CN
name: Cetirizine Hydrochloride
lang: EN
name: セチリジン塩酸塩
lang: JP
name: 氟维司群
lang: CN
name: Fulvestrant
lang: EN
name: フルベストラント
lang: JP
name: 卡匹色替
lang: CN
name: Capivasertib
lang: EN
name: カピバセルチブ (JAN)
lang: JP
name: 盐酸洛哌丁胺
lang: CN
name: Loperamide Hydrochloride
lang: EN
name: ロペラミド塩酸塩
lang: JP
Clinical trial NCT02344225: Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)
Official title: Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP STUDY)
Conditions: Retinopathy of Prematurity
Summary: Phase 2, open-label, randomized, multi-center studies in infants and premature infants are necessary to determine treatment and preventative strategies for ROP. This study was designed to: a) target infants at the highest risk of ROP in a large number of centers with variable rates of ROP (all stages and severe ROP or stage 3+); and b) assess whether caffeine plus systemic or ophthalmic NSAID will decrease ROP among infants most at risk for ROP. The study is designed to determine whether the novel treatment regimens are safe and potentially effective for ROP prevention and to obtain requisite data for the development of a Phase III efficacy/safety randomized blinded trial. Since caffeine is used extensively in NICUs as standard of care for ELGANs, no placebo group is included.
Interventions:
description: Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose)
name: Caffeine citrate
other_name: Caffeine
type: Drug
description: Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days
name: Ibuprofen
other_name: Neoprofen
type: Drug
description: Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days
name: Ketorolac
other_name: Acuvail
type: Drug
Study arms:
design_group_description: Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose) plus placebo saline IV (1 ml/kg followed by 0.25 ml/kg) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Caffeine is the intervention
design_group_title: Caffeine+Saline IV+Saline drops
design_group_type: Active Comparator
design_group_description: Caffeine citrate as described in group 1, plus Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Ibuprofen is the intervention
design_group_title: Caffeine+Ibp IV+Saline drops
design_group_type: Experimental
design_group_description: Caffeine citrate plus saline IV placebo as described in group 1, and Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days (n=40); Ketorolac is the intervention
design_group_title: Caffeine+Saline+Ketorolac drops
design_group_type: Experimental
Sponsor: State University of New York at Downstate Medical Center
Collaborators: US Food & Drug Administration
National Institute of Child Health & Human Development
Drug name mappings:
name: 酮咯酸氨丁三醇
lang: CN
name: Ketorolac Tromethamine
lang: EN
name: 布洛芬
lang: CN
name: Ibuprofen
lang: EN
name: イブプロフェン
lang: JP
Clinical trial NCT00334256: Tenofovir/Emtricitabine for PMTCT in Africa and Asia (ANRS 12109 TEmAA)
Official title: Phase II Trial, Multicentre, Opened Label Evaluating the Pharmacokinetics and the Safety and Toxicity of the Tenofovir-Emtricitabine Combination in Pregnant Women and Infants in Africa and Asia
Conditions: HIV Infection
Pregnancy
Summary: To study the pharmacokinetic properties, safety and viral resistance pattern of the combination of tenofovir disoproxil fumarate and emtricitabine in HIV-1-infected pregnant women and their newborns, with a view to prevention of mother-to-child transmission (PMTCT) of HIV-1 in Africa and Asia.
Interventions:
name: Tenofovir (TDF)
type: Drug
name: Emtricitabine (FTC)
type: Drug
Study arms:
Sponsor: France Recherche Nord & Sud SIDA HIV-Hepatites
Collaborators: Gilead Sciences, Inc.
Drug name mappings:
name: 替诺福韦
lang: CN
name: Tenofovir
lang: EN
name: 恩曲他滨
lang: CN
name: Emtricitabine
lang: EN
name: エムトリシタビン
lang: JP
Clinical trial NCT03926195: Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthritis
Official title: A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Non-Radiographical Axial Spondyloarthritis
Summary: The primary objective of this study is to evaluate the effect of filgotinib on semen parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.
Results of this study may be pooled with the results of a separate study being conducted in participants with inflammatory bowel disease (Protocol GS-US-418-4279; NCT03201445) with the same objective.
Interventions:
description: 200-mg tablet administered orally once daily
name: Filgotinib
other_name: GS-6034
Jyseleca®
type: Drug
description: Placebo to match filgotinib tablet administered orally once daily
name: Placebo
type: Drug
description: Locally approved treatment, accepted by medical experts as a proper treatment for rheumatic conditions, prescribed according to best clinical practice, with no known testicular toxicity.
name: Standard of Care
type: Drug
Study arms:
design_group_description: Participants received filgotinib 200 milligrams (mg) tablet, orally, once daily up to Week 13 in the double-blind (DB) phase. At Week 13, participants who were arthritis responders, were unblinded and received open-label (OL) treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the extension (EXT) phase and participants who were arthritis nonresponders discontinued blinded study drug and started standard of care (SOC) treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.
design_group_title: Filgotinib
design_group_type: Experimental
design_group_description: Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Galapagos NV
Collaborators: Gilead Sciences, Inc.
Drug name mappings:
name: 非戈替尼
lang: CN
name: Filgotinib Maleate
lang: EN
name: フィルゴチニブマレイン酸塩
lang: JP
Clinical trial NCT05969496: Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus
Official title: Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Associated Inferior Vena Cava Tumor Thrombus (NEOPAX)
Conditions: Renal Cancer
Kidney Cancer
Renal Cell Carcinoma
Inferior Vena Cava Thrombosis
Summary: The primary objective of this study is to evaluate whether the combination of Pembrolizumab and Axitinib given in the neoadjuvant setting can change the Inferior Vena Cava Tumor Thrombus burden. A decrease in the size of the tumor thrombus can potentially lead to decrease in surgical complications, improve patient related health outcomes, and improve long term outcomes such as progression free survival and overall survival.
Interventions:
description: Axitinib is a potent oral, vascular endothelial growth factor, c-kit and platelet derived growth factor inhibitor.
name: Axitinib
other_name: Inlyta
type: Drug
description: Pembrolizumab is a type of immunotherapy. It stimulates the body's immune system to fight cancer cells. Pembrolizumab targets and blocks a protein called PD-1 on the surface of certain immune cells called T-cells. Blocking PD-1 triggers the T-cells to find and kill cancer cells.
name: Pembrolizumab
other_name: Keytruda
type: Drug
Study arms:
design_group_description: Neoadjuvant therapy with the combination of Pembrolizumab and Axitinib will be given for eligible RCC patients with an IVC TT for a total of 12 weeks. Patients will then undergo imaging with a contrast enhanced, diffusion weighted imaging MRI of the abdomen to evaluate the IVC TT response. A CT chest will also be done to ensure there is no progression of disease. Patients can undergo definitive surgery per treating Urologist within 2 weeks (+/- 7 days) after end of treatment scan.
design_group_title: Combination Pembrolizumab and Axitinib
design_group_type: Experimental
Sponsor: University of Colorado Denver
Collaborators: Cancer League of Colorado
Drug name mappings:
name: 阿昔替尼
lang: CN
name: Axitinib
lang: EN
name: アキシチニブ
lang: JP
name: 帕博利珠单抗
lang: CN
name: Pembrolizumab
lang: EN
name: ペムブロリズマブ（遺伝子組換え）
lang: JP
Clinical trial NCT04186988: [18F]-AraG for the Detection of T-Cell Activation in Advanced Non-small Cell Lung Cancer Patients Undergoing PD-1/PD-L1-Directed Therapy
Official title: Imaging of T-Cell Activation With [18F]-AraG in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1-Directed Therapy
Conditions: Advanced Lung Non-Small Cell Carcinoma
Metastatic Lung Non-Small Cell Carcinoma
Stage III Lung Cancer AJCC v8
Stage IIIA Lung Cancer AJCC v8
Stage IIIB Lung Cancer AJCC v8
Stage IIIC Lung Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
Stage IVA Lung Cancer AJCC v8
Stage IVB Lung Cancer AJCC v8
Summary: This trial studies how well [18F]-AraG works in detecting T-cell activation in patients with non-small cell lung cancer that has spread to other places in the body (advanced), who are undergoing PD-1/PD-L1-directed therapy. [18F]-AraG is a "radiotracer" which attaches to immune cells directed at the cancer and shines a light that can be seen using a special camera, called a "positron emission tomography" or "PET" scanner. [18F]-AraG may improve the ability to detect a response of the cancer in the body to immunotherapy.
Interventions:
description: Given IV
name: Fluorine F 18 Ara-G
other_name: 18F-F-Ara-G
[18F]F-AraG
[18F]F-ara-G
type: Drug
Study arms:
design_group_description: Patients receive [18F]-AraG IV and then undergo PET/CT over 2 hours at baseline and within 2 weeks after starting immunotherapy. Patients may also undergo blood sample collection.
design_group_title: Diagnostic ([18F]-AraG)
design_group_type: Experimental
Sponsor: University of California, Davis
Collaborators: National Cancer Institute
CellSight Technologies, Inc.
Drug name mappings:
name: [18F]F-AraG
lang: EN