PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT03660839: Study to Investigate the Clinical and Parasiticidal Activity and Pharmacokinetics of Different Doses of Artefenomel and Ferroquine in Patients With Uncomplicated Plasmodium Falciparum Malaria
Official title: A Randomized, Open Label, Parallel-group, Single Dose Regimen, Phase 2a Study, to Investigate the Clinical and Parasiticidal Activity and the Pharmacokinetics of 3 Dose Levels of Artefenomel (OZ439) Given in Combination With Ferroquine (FQ) and FQ Alone, in African Patients With Uncomplicated Plasmodium Falciparum Malaria
Conditions: Plasmodium Falciparum Infection
Summary: Primary Objective:
To show the contribution of artefenomel (OZ439) to the clinical and parasiticidal effect of OZ439/Ferroquine (FQ) combination by analyzing exposure-response of OZ439 measured by Day 28 polymerase chain reaction (PCR)-corrected adequate clinical and parasitological response (ACPR) for the effect and the area under the curve (AUC) of OZ439 as pharmacokinetic (PK) predictor.
Secondary Objectives:
* To evaluate the exposure-response of OZ439 combined with FQ on crude Day 28 ACPR.
* To evaluate the dose response of OZ439 combined with FQ on PCR-corrected and crude Day 28 ACPR.
* To evaluate the dose-response of OZ439 combined with FQ on selected secondary endpoints.
* To evaluate the safety and tolerability of different dosages of OZ439 in combination with FQ and FQ alone.
* To characterize the PK of OZ439 in plasma, and of FQ and its active metabolite SSR97213 in blood.
Interventions:
description: Pharmaceutical form: Granules for oral suspension Route of administration: Oral
name: Artefenomel (OZ439)
type: Drug
description: Pharmaceutical form: Capsule Route of administration: Oral
name: Ferroquine (SSR97193)
type: Drug
Study arms:
design_group_description: On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition.
design_group_title: Ferroquine 400 milligram (mg)
design_group_type: Experimental
design_group_description: On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 300 mg oral suspension.
design_group_title: Ferroquine 400 mg + Artefenomel 300 mg
design_group_type: Experimental
design_group_description: On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 600 mg oral suspension.
design_group_title: Ferroquine 400 mg + Artefenomel 600 mg
design_group_type: Experimental
design_group_description: On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 1000 mg oral suspension.
design_group_title: Ferroquine 400 mg + Artefenomel 1000 mg
design_group_type: Experimental
Sponsor: Sanofi
Collaborators: MMV Medicines for Malaria Venture
Drug name mappings:
name: Artefenomel Mesylate
lang: EN
name: Ferroquine
lang: EN
Clinical trial NCT06161688: Ensitrelvir for Viral Persistence and Inflammation in People Experiencing Long COVID
Official title: Placebo-Controlled, Randomized Trial of Ensitrelvir (S-217622) for Viral Persistence and Inflammation in People Experiencing Long COVID (PREVAIL-LC)
Conditions: Long COVID
Post Acute Sequelae of COVID-19
Post-Acute COVID-19
Summary: Persistent viral infection with viral reservoirs and detection of circulating spike protein after the initial acute illness is one potential pathogenic mechanism for Long COVID. This mechanism may be susceptible to antiviral therapy that blocks viral replication, which has the potential to alleviate long COVID symptoms. This trial will study the safety and efficacy of Ensitrelvir (S-217622), an antiviral, to treat individuals with Long COVID in an adult population.
Interventions:
description: Those randomized to the experimental arm will receive Ensitrelvir, a protease inhibitor, taken orally for 5 days
name: Ensitrelvir
other_name: ensitrelvir fumaric acid
type: Drug
description: Matching placebo for Ensitrelvir
name: Placebo
type: Other
Study arms:
design_group_description: Ensitrelvir fumaric acid (S-217622) given orally 375 mg on day 1 followed by 125 mg daily for 4 additional days
design_group_title: Ensitrelvir (S-217622)
design_group_type: Experimental
design_group_description: Placebo administered orally for 5 days
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: The University of California, San Francisco
Collaborators: Shionogi, Inc.
Drug name mappings:
name: 恩赛特韦
lang: CN
name: Ensitrelvir Fumaric Acid
lang: EN
name: エンシトレルビル フマル酸
lang: JP
Clinical trial NCT03511391: CHEckpoint Inhibition in Combination With an Immunoboost of External Beam Radiotherapy in Solid Tumors
Official title: CHEckpoint Inhibition in Combination With an Immunoboost of External Beam Radiotherapy in Solid Tumors: CHEERS-trial
Conditions: Urothelial Carcinoma
Melanoma
Renal Cell Carcinoma
Non-small Cell Lung Cancer
Head and Neck Cancer
Summary: This randomized controlled phase II trial will investigate whether the addition of stereotactic body radiotherapy to checkpoint inhibitor treatment in patients with non-small-cell lung carcinoma, urothelial carcinoma, renal cell carcinoma, melanoma or head-and-neck carcinoma can improve progression-free survival as compared to checkpoint inhibitor monotherapy. The primary outcome is progression-free survival; secondary outcomes include overall survival, response according to iRecist and Recist v1.1 and toxicity.
Interventions:
description: per national standard of care
name: Nivolumab or Pembrolizumab or Atezolizumab
other_name: Immune checkpoint inhibitor
type: Drug
description: Stereotactic body radiotherapy is administered to maximally 3 lesions in 3 fractions of 8Gy prior to the second/third cycle of checkpoint inhibitors.
name: SBRT
other_name: Stereotactic body radiotherapy, SABR, Stereotactic ablative radiotherapy
type: Radiation
Study arms:
design_group_description: Stereotactic body radiotherapy concurrent with checkpoint inhibitor treatment:<br/>Nivolumab or Pembrolizumab or Atezolizumab + SBRT
design_group_title: Experimental arm
design_group_type: Experimental
design_group_description: Checkpoint inhibitor treatment only:<br/>Nivolumab or Pembrolizumab or Atezolizumab monotherapy
design_group_title: Control arm
design_group_type: Active Comparator
Sponsor: Ghent University Hospital
Collaborators: Az Sint-Lucas Gent
AZ Sint Lucas Brugge
Jules Bordet Institute
Drug name mappings:
name: 纳武利尤单抗
lang: CN
name: Nivolumab
lang: EN
name: ニボルマブ（遺伝子組換え）
lang: JP
name: 阿替利珠单抗
lang: CN
name: Atezolizumab
lang: EN
name: アテゾリズマブ（遺伝子組換え）
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 NCT03012581: Secured Access to Nivolumab for Adult Patients With Selected Rare Cancer Types
Official title: Secured Access to Nivolumab for Adult Patients With Selected Rare Cancer Types
Conditions: Carcinoma, Renal Cell
Head and Neck Neoplasm
Skin Neoplasms
Microsatellite Instability
Penile Neoplasms
Cancer With POLE Exonucleasic Domain Mutation
Summary: This is a Phase 2, non-randomised, open-label, multicentric study to investigate the efficacy and safety of nivolumab monotherapy in 6 cohorts of patients with specific rare cancers who have unresectable locally advanced or metastatic disease, which is resistant or refractory to standard therapy, or for which standard therapy does not exist, or is not considered appropriate, and for which no other experimental treatment options are available.
Interventions:
description: Treatment
name: Nivolumab
other_name: Opdivo
type: Drug
Study arms:
design_group_description: Nivolumab 240 mg IV over 60 minutes every 14 days.
design_group_title: Nivolumab
design_group_type: Experimental
Sponsor: UNICANCER
Collaborators: National Cancer Institute
Ligue Contre Le Cancer
Bristol Myers Squibb Co.
Drug name mappings:
name: 纳武利尤单抗
lang: CN
name: Nivolumab
lang: EN
name: ニボルマブ（遺伝子組換え）
lang: JP
Clinical trial NCT02077998: Oxaliplatin in Treating Patients With Metastatic Breast Cancer
Official title: A Diagnostic Feasibility Trial of a [14C]Oxaliplatin Microdosing Assay for Prediction of Chemoresistance to Oxaliplatin Chemotherapy
Conditions: Stage IV Breast Cancer
Summary: This phase 0/II trial studies the effect of carbon C 14 oxaliplatin in tumor tissue and blood and the side effects and how well oxaliplatin works in treating patients with metastatic breast cancer. DNA analysis of tumor tissue and blood samples from patients receiving carbon C 14 oxaliplatin may help doctors predict how well patients will respond to treatment with oxaliplatin. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Interventions:
description: Given IV
name: carbon C 14 oxaliplatin
other_name: [14C] oxaliplatin
type: Radiation
description: Given IV
name: oxaliplatin
other_name: 1-OHP
Dacotin
Dacplat
Eloxatin
L-OHP
type: Drug
description: Correlative studies
name: laboratory biomarker analysis
type: Other
Study arms:
design_group_description: PHASE 0: Patients receive carbon C 14 oxaliplatin IV over 2 minutes on day 1.<br/>PHASE II: Patients receive oxaliplatin IV over 2 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
design_group_title: Diagnostic (carbon C 14 oxaliplatin and oxaliplatin)
design_group_type: Experimental
Sponsor: University of California, Davis
Collaborators: National Cancer Institute
Drug name mappings:
name: 奥沙利铂
lang: CN
name: Oxaliplatin
lang: EN
name: オキサリプラチン
lang: JP
Clinical trial NCT01836068: Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Individuals
Official title: Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1-infected Individuals
Conditions: HIV
Summary: To find out if it is possible for HIV-1 patients to maintain antiretroviral medications during allogeneic bone marrow transplant
Interventions:
description: Enfuvirtide 90 mg subcutaneously twice daily will be administered to all patients on day 3 and 4 post-transplant and during any periods when oral medications are not expected to be tolerated for ≥ 24 hours, or during periods when ART is held due to interactions
name: Enfuvirtide
other_name: Fuzeon
type: Drug
Study arms:
design_group_description: Enfuvirtide 90 mg subcutaneously every 12 hours will be also be administered during any periods when oral medications are not expected to be tolerated for ≥ 24 hours, or during periods when ART is held due to interactions with conditioning regimens in patients who require ritonavir-boosted PI containing ART regimens.
design_group_title: Enfuvirtide monotherapy
design_group_type: Experimental
Sponsor: The Sidney Kimmel Comprehensive Cancer Center
Collaborators: National Institute of Allergy & Infectious Diseases
Drug name mappings:
name: 恩夫韦肽
lang: CN
name: Enfuvirtide
lang: EN
Clinical trial NCT02420665: Use of High-Resolution Microendoscopy (HRME) in Patients With Cervical Dysplasia
Official title: Use of High-Resolution Microendoscopy (HRME) in Patients With Cervical Dysplasia
Conditions: Cervical Cancer
Summary: The goal of this clinical research study is to compare a type of imaging called high-resolution microendoscopy (HRME) for detecting abnormal tissue in the cervix to the standard of care, which is visual inspection with acetic acid (VIA) with a colposcopy procedure. Researchers also want to learn if HRME images can show the difference between cancerous tissue and normal cervical tissue.
Interventions:
description: 0.01% Proflavine applied topically to the cervix after colposcopy and HRME cervical images obtained.
name: Proflavine
type: Drug
description: HRME images obtained from one visually normal cervical site, and from up to 3 visually abnormal lesions based on exam and/or colposcopic findings.
name: HRME Imaging
other_name: High-Resolution Microendoscopy
type: Device
description: Study staff follow up with participant by phone one month after procedure.
name: Phone Call
type: Behavioral
description: Colposcopy performed after visual inspection of cervix.
name: Colposcopy
type: Procedure
description: 3 - 5% added to cervix before visual inspection.
name: Acetic Acid
type: Drug
Study arms:
design_group_description: Visual inspection of cervix performed using 3 - 5% acetic acid to the cervix. Participants undergo standard colposcopy and abnormal lesions noted by quadrant. Then 0.01% proflavine applied topically to the cervix. High-resolution microendoscopy (HRME) then performed. HRME images obtained from one visually normal site and from up to 3 visually abnormal lesions based on visual exam and/or colposcopic findings. Study staff follow up with participant by phone one month after procedure.
design_group_title: High-Resolution Microendoscopy (HRME) + Colposcopy
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: National Cancer Institute
National Institutes of Health
Drug name mappings:
name: 酢酸
lang: CN
name: Acetic Acid, Glacial
lang: EN
name: 氷酢酸
lang: JP
name: 原黄素
lang: CN
name: Proflavine
lang: EN
Clinical trial NCT05490264: [68Ga]Ga-NOTA-SNA002 (PD-L1 PET Tracer) for PET/CT in Patients With Solid Tumors
Official title: [68Ga]Ga-NOTA-SNA002 (PD-L1 PET Tracer) for PET/CT in Patients With Solid Tumors
Conditions: Solid Tumor
Positron-Emission Tomography(PET)
Summary: The purpose of this study is to evaluate the safety of [68Ga]Ga-NOTA-SNA002 and investigate the uptake of [68Ga]Ga-NOTA-SNA002 in patients with solid tumors.
Interventions:
description: [68Ga]Ga-NOTA-SNA002（PD-L1 PET Tracer）for Positron Emission Tomography
name: [68Ga]Ga-NOTA-SNA002
type: Biological
Study arms:
design_group_description: A dose of 1mCi-5mCi of [68Ga]Ga-NOTA-SNA002 between 0.1mg to 0.9mg will be administered intravenously over 5minutes in Day 1 of subject enrollment
design_group_title: [68Ga]Ga-NOTA-SNA002
design_group_type: Experimental
Sponsor: Suzhou SmartNuclide Biopharmaceutical Co., Ltd.
Collaborators: The First Affiliated Hospital of Soochow University
Drug name mappings:
name: 镓[68Ga]纳坦重组PD-L1单域抗体(Suzhou SmartNuclide Biopharmaceutical)
lang: CN
name: [68Ga] anti-PD-L1 nanobody(Suzhou SmartNuclide Biopharmaceutical)
lang: EN
Clinical trial NCT02382549: A Clinical Trial to Evaluate a Melanoma Helper Peptide Vaccine Plus Dabrafenib and Trametinib
Official title: A TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A HELPER PEPTIDE VACCINE PLUS COMBINATION OF BRAF INHIBITION AND MEK INHIBITION (MEL61)
Conditions: Melanoma
Summary: This study evaluates whether it is safe to administer a helper peptide vaccine with BRAF inhibitor and MEK inhibitor therapy. This study will also evaluate the effects of the combination of the peptide vaccine and BRAF inhibitors/MEK inhibitors on the immune system. We will monitor these effects by performing tests in the laboratory on participants' blood and tumor samples.
Interventions:
description: BRAF inhibitor
name: BRAF inhibitor
type: Drug
description: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
name: 6MHP
other_name: 6 melanoma helper peptide vaccine
type: Biological
description: MEK Inhibitor
name: MEK inhibitor
type: Drug
Study arms:
design_group_description: The vaccine drug product, 6MHP, consists of 6 class II MHC-restricted peptides derived from melanoma proteins. Each vaccine consists of 200 mcg of each of the six peptides. An aqueous solution of vaccine is mixed 1/1 with Montanide ISA-51 to form water-in-oil emulsions. Vaccines are administered days 1, 8, 15, 36, 57, 78. All peptide vaccines are administered intradermally and subcutaneously.<br/>A selective BRAF inhibitor and a selective MEK inhibitor will be administered in accordance with the prescribing information.
design_group_title: 6MHP and MEKi and BRAFi
design_group_type: Experimental
Sponsor: University of Virginia
Collaborators: National Cancer Institute
Drug name mappings:
name: 6-melanoma helper peptide vaccine(University of Virginia)
lang: EN
Clinical trial NCT04230681: Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery
Official title: A Randomized Controlled Trial to Compare Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery
Conditions: Obstructive Sleep Apnea
Tonsillitis
Summary: A RCT to compare hydromorphone versus fentanyl for pain control following tonsillectomy or adenotonsillectomy surgery.
Interventions:
description: Patients will be randomized to one of two opioids for the treatment of post-operative pain.
name: Hydromorphone
type: Drug
description: Fentanyl
name: Fentanyl
type: Drug
Study arms:
design_group_title: Fentanyl
design_group_type: Active Comparator
design_group_title: Hydromorphone
design_group_type: Active Comparator
Sponsor: Washington University School of Medicine
Collaborators: National Center for Advancing Translational Sciences
Drug name mappings:
name: 枸橼酸芬太尼
lang: CN
name: Fentanyl Citrate
lang: EN
name: フェンタニルクエン酸塩
lang: JP
name: 盐酸氢吗啡酮
lang: CN
name: Hydromorphone Hydrochloride
lang: EN
name: ヒドロモルフォン塩酸塩
lang: JP
Clinical trial NCT01843855: The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass
Official title: The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass
Conditions: Type 2 Diabetes Mellitus
Summary: The study is being undertaken to understand how a gastric bypass can affect a subject's diabetes even prior to their losing significant amounts of weight. The hypothesis of this study is that increased glucagon-like peptide-1 (GLP-1) secretion explains the amelioration in insulin secretion after Roux-en-Y Gastric Bypass (RYGB) surgery.
Interventions:
description: Exendin 9,39 is a competitive antagonist of endogenous GLP-1.
name: Exendin 9,39
type: Drug
description: A saline infusion will be given to match the study drug infusion.
name: Placebo
type: Drug
Study arms:
design_group_description: Subjects randomized to this arm will receive an infusion of exendin 9,39 of 300mmol/kg/min for 360 minutes.
design_group_title: Exendin 9,39
design_group_type: Experimental
design_group_description: Subjects randomized to this arm will receive a saline infusion for 360 minutes.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Mayo Clinic
Collaborators: National Institute of Diabetes & Digestive & Kidney Diseases
National Center for Research Resources
Drug name mappings:
name: Avexitide
lang: EN
Clinical trial NCT01184885: A Pilot Study to Determine the Safety and Tolerability of Sirolimus Given With Hyper-CVAD Chemotherapy
Official title: A Pilot Study of Hyperfractionated Cyclophosphamide, Vincristine, Doxorubicin, and Dexamethasone (Hyper-CVAD) With Sirolimus for the Treatment of Adult Acute Lymphoblastic Leukemia and Aggressive Lymphoid Malignancies
Conditions: Lymphoid Malignancies (New or Relapsed)
Acute Lymphoblastic Leukemia
Burkitt Lymphoma
Lymphoblastic Lymphoma
Mantle Cell Lymphoma
Adult T-cell Leukemia/Lymphoma
Summary: This is a pilot study, assessing the feasibility, safety and toxicity of an mTOR (mammalian target of Rapamycin) inhibitor (MTI), rapamycin, when administered with HyperCVAD (Hyperfractionated Cyclophosphamide, Vincristine, Doxorubicine and Dexamethasone), with an ultimate goal to perform a phase II study to evaluate response rates and survival in adults with Acute Lymphoblastic Leukemia (ALL) and aggressive lymphoid malignancies.
Interventions:
description: * Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.<br/>* Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.<br/>* Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.
name: Hyper-CVAD
other_name: Adriamycin
Amethopterin
Cytophosphane
Cytoxan
Endoxan
Hydroxydaunorubicin
Leurocristine
MTX
Neosar
Oncovin
Procytox
Revimmune
type: Drug
description: Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)
name: Sirolimus
other_name: Rapamycin
type: Drug
Study arms:
design_group_description: Hyper-CVAD and Sirolimus
design_group_title: Hyper-CVAD and Sirolimus
design_group_type: Experimental
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators: American Society of Clinical Oncology, Inc.
Drug name mappings:
name: 西罗莫司
lang: CN
name: Sirolimus
lang: EN
name: シロリムス
lang: JP
Clinical trial NCT06511037: PhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis
Official title: The Impact of Pafolacianine Injection for Intraoperative Imaging on Outcomes of Gastrointestinal Cancer Peritoneal Carcinomatosis - A Pilot Study
Conditions: Gastrointestinal Cancer
Peritoneal Carcinomatosis
Summary: This is a pilot, single-arm, open label study to evaluate the ability of CYTALUX™ (pafolacianine) to help identify cancerous lesions in subjects with gastrointestinal cancers and peritoneal carcinomatosis during cytoreductive surgery.
Interventions:
description: Given IV
name: Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging
type: Drug
Study arms:
design_group_description: All subjects will receive one single intravenous infusion of 0.025 mg/kg of pafolacianine (CYTALUX) injection prior to anticipated intraoperative imaging planned for cytoreductive surgery.
design_group_title: Pafolacianine (CYTALUX)
design_group_type: Experimental
Sponsor: University of California, Irvine
Collaborators: On Target Laboratories, Inc.
Drug name mappings:
name: Pafolacianine
lang: EN
Clinical trial NCT06656702: Effects of Psilocybin in Patients With Amyotrophic Lateral Sclerosis
Official title: Effects of Psilocybin in Patients With Amyotrophic Lateral Sclerosis
Conditions: Amyotrophic Lateral Sclerosis
Summary: This study aims to study the feasibility of psilocybin therapy for patients with Amyotropic Lateral Sclerosis (ALS) with depressed mood. The secondary objective is to assess its impact on depression, quality of life, hopelessness, and functional status in this patient population.
Interventions:
description: Psilocybin Trihydrate. Participants will complete an 8-week course of study treatment including two psilocybin sessions (15 mg in week 4 and 15 or 25 mg in week 6), with follow-up assessments 1, 3, and 6 months after the final psilocybin session.
name: Psilocybin
type: Drug
Study arms:
design_group_description: All subjects will be in the same, open label arm
design_group_title: Psilocybin
design_group_type: Other
Sponsor: The Johns Hopkins University
Collaborators: Defense Language Institute Foreign Language Center
Drug name mappings:
name: 裸盖菇素
lang: CN
name: Psilocybin
lang: EN