PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT03599453: Chemokine Modulation Therapy and Pembrolizumab in Treating Participants With Metastatic Triple-Negative Breast Cancer
Official title: Pilot Open Label Clinical Trial Evaluating the Safety and Efficacy of Chemokine Modulation to Enhance the Effectiveness of Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer
Conditions: Triple -Negative Breast Cancer
Estrogen Receptor Negative
HER2/Neu Negative
Anatomic Stage IV Breast Cancer AJCC
Progesterone Receptor Negative
Summary: This pilot trial studies how well chemokine modulation therapy works when given prior to pembrolizumab in treating participants with triple-negative breast cancer that has spread to other places in the body. Drugs used in chemokine modulation therapy, such as celecoxib, recombinant interferon alfa-2b, and rintatolimod, work by unleashing or enhancing the cancer immune responses that already exist by either blocking inhibitory molecules or by activating stimulatory molecules. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving chemokine modulation therapy before pembrolizumab may work better in treating participants with metastatic triple-negative breast cancer
Interventions:
description: Undergo Biopsy
name: Biopsy
type: Procedure
description: Undergo chemokine modulation therapy
name: Chemokine Modulation Therapy
type: Procedure
description: Given by mouth
name: Celecoxib
other_name: Celebrex, YM 177, Benzenesulfonamide
type: Drug
description: Given intravenously
name: Recombinant Interferon Alfa-2b
other_name: Alfatronol, Glucoferon, Heberon Alfa, IFN alpha-2B, Interferon alfa 2b, Intron A, recombinant interferon alfa-2b, Recombinant Interferon Alfa-2b, Sch
type: Biological
description: Given intravenously
name: Rintatolimod
other_name: 38640-92-5, 616524, Ampligen, Ampligen, Atvogen, Poly(I).Poly(c12,U), Poly(Inosinic Acid) Poly(Cytidylic(12), Uridylic)Acid, RINTATOLIMOD, Rintatolimod
type: Drug
description: Given intravenously
name: Pembrolizumab
other_name: Immunoglobulin G4,Keytruda, Lambrolizumab
type: Biological
Study arms:
design_group_description: Participants undergo pre-treatment biopsy. Participants then undergo chemokine modulation therapy consisting of celecoxib PO BID, recombinant interferon alfa-2b IV over 20 minutes, and rintatolimod IV over 30-60 minutes on days -11 to -9, and -4 to -2. Participants then undergo additional biopsy. Following biopsy and chemokine modulation therapy, participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
design_group_title: Treatment (chemokine modulation therapy)
design_group_type: Experimental
Sponsor: Roswell Park Comprehensive Cancer Center
Collaborators: AIM ImmunoTech, Inc.
Drug name mappings:
name: 重组人干扰素α-2b(Merck Sharp & Dohme )
lang: CN
name: INTERFERON ALFA-2B(Merck Sharp & Dohme )
lang: EN
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
name: 安普利近
lang: CN
name: Rintatolimod
lang: EN
name: 塞来昔布
lang: CN
name: Celecoxib
lang: EN
name: セレコキシブ
lang: JP
Clinical trial NCT04723862: Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?
Official title: Does Spironolactone Normalize Sleep-wake Luteinizing Hormone (LH) Pulse Frequency in Pubertal Girls With Hyperandrogenism? (CBS010)
Conditions: Hyperandrogenism
Polycystic Ovary Syndrome
Puberty
Summary: The purpose of this study is to determine if, in mid- to late pubertal girls with hyperandrogenism (HA), androgen-receptor blockade (spironolactone) alone normalizes sleep-wake luteinizing hormone (LH) pulse frequency (primary endpoint) and overall LH and follicle-stimulating hormone secretion (secondary endpoints).
Interventions:
description: Spironolactone is an androgen-receptor blocker commonly used (off-label) for hyperandrogenism. The spironolactone dose will be 50 mg taken orally twice daily (for two weeks before admission to the Clinical Research Unit).
name: Spironolactone
type: Drug
description: Placebo contains only inert ingredients and is not expected to exert any direct physiological effects.
name: Placebo
type: Drug
Study arms:
design_group_description: Prior to the first or second admission (randomly determined), participants will be pretreated for 2 weeks with spironolactone (50 mg twice daily).
design_group_title: Spironolactone
design_group_type: Experimental
design_group_description: Prior to the first or the second admission (randomly determined), participants will be pretreated for 2 weeks with placebo (twice daily).
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University of Virginia
Collaborators: National Institute of Child Health & Human Development
Drug name mappings:
name: 螺内酯
lang: CN
name: Spironolactone
lang: EN
name: スピロノラクトン
lang: JP
Clinical trial NCT07381582: Safety, Tolerability and Preliminary Efficacy of 161Tb-LNC1011 (PSMA Radioligand) in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Official title: A Prospective, Open-label, Dose-Escalation, Single-Center Study to Evaluate the Safety, Biodistribution/Dosimetry and Preliminary Efficacy of 161Tb-LNC1011 in Patients With Metastatic Castration-Resistant Prostate Cancer
Conditions: Prostate Cancer
Summary: This is a prospective, open-label, single-center, dose-escalation study using a standard 3+3 design to assess the safety, tolerability, biodistribution/dosimetry and preliminary efficacy of the albumin-binding PSMA radioligand 161Tb-LNC1011 in patients with metastatic castration-resistant prostate cancer (mCRPC). Patients will receive intravenous 161Tb-LNC1011 starting at 50 mCi with planned dose-level escalations to 80, 130 and 200 mCi (±10%). Early dose levels (50 mCi) receive 1 cycle; later levels receive up to 4 cycles every 6 weeks based on safety and disease status. Primary endpoints include dose-limiting toxicities (DLTs), adverse events (AEs) graded by CTCAE v5.0, and determination of maximum tolerated dose (MTD). Secondary endpoints include organ/tumor absorbed doses, PSA responses (PSA50/PSA90), disease control, time to PSA progression and radiographic progression-free survival per PCWG3.
Interventions:
description: Intravenous administration; planned dose levels: 50, 80, 130, 200 mCi (±10%); cycle interval q6 weeks; up to 1 cycle at 50 mCi and up to 4 cycles at later dose levels as permitted by safety and disease status.
name: 161Tb-LNC1011
type: Drug
Study arms:
design_group_description: Single-group, open-label, sequential dose escalation of 161Tb-LNC1011 (IV). Planned dose levels: 50, 80, 130, 200 mCi (±10%). At 50 mCi: 1 cycle; higher levels: up to 4 cycles every 6 weeks, contingent on safety and disease status. DLT window: 6 weeks post-dose; MTD per standard 3+3 rules (≥2/6 DLTs defines exceeding dose). Retreatment requires hematologic recovery to CTCAE ≤ Grade 1 or baseline. Post-dose SPECT/CT at <br/>30 min, 2 h, 8 h, 24 h, Day 2, Day 7 for dosimetry; disease assessments with 68Ga-PSMA-11 PET/CT and labs per schedule.
design_group_title: Dose-Escalation Cohort (3+3): 161Tb-LNC1011
design_group_type: Experimental
Sponsor: Peking Union Medical College Hospital
Collaborators: Mianyang Central Hospital
Drug name mappings:
name: 161Tb-LNC1011
lang: EN
Clinical trial NCT03575598: Sitravatinib (MGCD516) and Nivolumab in Oral Cavity Cancer Window Opportunity Study
Official title: Sitravatinib (MGCD516) and Nivolumab in Oral Cavity Cancer Window Opportunity Study (SNOW)
Conditions: Squamous Cell Carcinoma, Head And Neck
Squamous Cell Carcinoma Mouth
Squamous Cell Carcinoma of the Oral Cavity
Summary: This is a window of opportunity study for patients with resectable squamous cell carcinoma of the oral cavity who are considered suitable for curative-intent surgical resection, with pre-operative drugs, Sitravatinib and Nivolumab.
Interventions:
description: Sitravatinib (MGCD516) is an orally-available, potent small molecule inhibitor of a closely related spectrum of tyrosine kinases, which has shown antitumor activity in a variety of in vitro and in vivo model systems.
name: Sitravatinib
other_name: MGCD516
type: Drug
description: Nivolumab (OPDIVO®) is a human IgG4 kappa immunoglobulin that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
name: Nivolumab
other_name: OPDIVO®
type: Biological
Study arms:
design_group_description: Patients will start therapy with sitravatinib within 10 days of study enrollment. Sitravatinib will be given at 120mg once daily on a continuous basis until 48 hours before planned surgery, or for a maximum period of 28 days.<br/>Nivolumab will be given as a single infusion at a dose of 240mg, over a period of 30 minutes on Day 15 of the study.
design_group_title: Sitravatinib and Nivolumab
design_group_type: Experimental
Sponsor: University Health Network
Collaborators: Mirati Therapeutics, Inc.
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: 司曲替尼
lang: CN
name: Sitravatinib
lang: EN
Clinical trial NCT02037035: Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling
Official title: Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling
Conditions: Depression
Summary: This study is looking at the mechanisms underlying the behavioral effects of ketamine in healthy and depressed individuals.
Interventions:
name: Ketamine
type: Drug
Study arms:
design_group_description: Healthy participants will receive ketamine in the scan
design_group_title: Healthy
design_group_type: Experimental
design_group_description: Depressed participants will receive ketamine in the scan
design_group_title: Depressed
design_group_type: Experimental
Sponsor: Yale University
Collaborators: American Psychiatric Association
National Institute of Mental Health
Drug name mappings:
name: 盐酸氯胺酮
lang: CN
name: Ketamine Hydrochloride
lang: EN
name: ケタミン塩酸塩
lang: JP
Clinical trial NCT06224049: Treatment of Relapsed or Refractory Epstein-Barr Virus Positive T-cell Lymphoma With hNeo-T
Official title: A Clinical Study to Evaluate the Safety, Tolerability and Initial Efficacy of Targeted Haploidentical Neoantigen T Cell Injection (hNeo-T) in the Treatment of Relapsed or Refractory EBV-positive T-cell Lymphoma
Conditions: T-cell Lymphoma
Summary: Objective: To evaluate the safety and tolerability of hNeo-T injection in patients with relapsed or refractory EBV-positive T-cell lymphoma.
Secondary objective: To evaluate the effectiveness of hNeo-T injection, and to evaluate the objective response rate (ORR) and disease control rate (DCR) by Lugano2014 criteria; Progression-free survival (PFS), duration of response (DOR), and overall survival (OS ) followed.
Objective of the exploratory study: To investigate the in vivo process of hNeo-T injection and describe the activity and related biological functions of hNeo-T cells in vivo, including but not limited to.
Interventions:
description: After subject screening, peripheral blood mononuclear cell （PBMC） donors matching half or more of the subject's HLA matching will undergo blood collection to prepare hNeo-T. hNeo-T preparation is expected to be 25-30 days after blood collection. In this study, the bridging therapy will be allowed before Chemotherapy preconditioning, and the investigators will decide whether to use it. Chemotherapy preconditioning will be performed before hNeo-T transfusion. If the absolute value of lymphocyte (LYM) before pretreatment is <0.8×10^9/L and the subject meets the criteria for cell transfusion, the chemotherapy preconditioning will not be performed and subsequent cell transfusion can be performed directly.
name: hNeo-T
type: Biological
description: Chemotherapy preconditioning will be performed before hNeo-T transfusion.
name: Cyclophosphamide
type: Drug
description: Chemotherapy preconditioning will be performed before hNeo-T transfusion
name: Fludarabine
type: Drug
Study arms:
design_group_description: The escalating doses of hNeo-T in this study will be 5*10^7 cells and1*10^8 cells.
design_group_title: hNeo-T
design_group_type: Experimental
Sponsor: BGI Genomics Co., Ltd.
Collaborators: Shenzhen University General Hospital
Drug name mappings:
name: 磷酸氟达拉滨
lang: CN
name: Fludarabine Phosphate
lang: EN
name: フルダラビンリン酸エステル
lang: JP
name: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
name: Targeted Neoantigen Haploidentical T Cell Injection(BGI Genomics)
lang: EN
Clinical trial NCT00894283: Comparing Enoxaparin to Fondaparinux to Prevent Venous Thromboembolism (VTE) in Bariatric Surgical Patients
Official title: A Pilot Study to Determine the Feasibility of Conducting a Randomized Clinical Trial Comparing Fondaparinux Sodium (Arixtra) Once Daily With Enoxaparin (Lovenox®) Twice Daily With Respect to Preventing VTE After Bariatric Surgery in Obese Patients
Conditions: Deep Venous Thrombosis
Pulmonary Embolism
Summary: This pilot study is designed to determine the feasibility of conducting a randomized clinical trial comparing fondaparinux sodium (Arixtra) once daily with enoxaparin (Lovenox®) twice daily with respect to preventing deep vein thrombosis (DVT) and pulmonary embolism (PE) after bariatric surgery in obese patients.
Interventions:
description: Patients will receive enoxaparin 40mg subcutaneously twice daily during perioperative period of bariatric surgery. Patients will be encouraged to ambulate and compression stockings while in bed.
name: Enoxaparin
type: Drug
description: Fondaparinux 5mg subcutaneously 6 hours following surgery, fondaparinux 5mg subcutaneously once daily during hospitalization. Patients will be encouraged to ambulate and compression stockings while in bed.
name: Fondaparinux
type: Drug
Study arms:
design_group_description: Patients will receive enoxaparin 40mg subcutaneously twice daily during perioperative period of bariatric surgery. Patients will be encouraged to ambulate and compression stockings while in bed.
design_group_title: Enoxaparin
design_group_type: Active Comparator
design_group_description: Fondaparinux 5mg subcutaneously 6 hours following surgery, fondaparinux 5mg subcutaneously once daily during hospitalization. Patients will be encouraged to ambulate and compression stockings while in bed.
design_group_title: Fondaparinux
design_group_type: Active Comparator
Sponsor: The Johns Hopkins University
Collaborators: GSK Plc
Drug name mappings:
name: 磺达肝癸钠
lang: CN
name: Fondaparinux Sodium
lang: EN
name: フォンダパリヌクスナトリウム
lang: JP
name: 依诺肝素钠
lang: CN
name: Enoxaparin Sodium
lang: EN
name: エノキサパリンナトリウム
lang: JP
Clinical trial NCT00708994: Cannabinoids, Neural Synchrony, and Information Processing
Official title: Cannabinoids, Psychosis, Neural Synchrony, and Information Processing
Conditions: Cannabis
Psychotic Disorders
Summary: The study examines the effects of delta-9-tetrahydrocannabinol (Δ9-THC), the principal active ingredient of cannabis, on neural synchrony. Neural synchrony is studied using electroencephalography (EEG).
Interventions:
description: * Very low dose (0.0015 mg/kg = 0.21 mg in a 70kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes.<br/>* Low dose (0.015 mg/kg = 1.05 mg in a 70kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.<br/>* Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/2 of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.
name: THC
type: Drug
description: • Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes
name: Placebo
type: Drug
Study arms:
design_group_description: * Very low dose (0.0015 mg/kg = 0.21 mg in a 70kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes.<br/>* Low dose (0.015 mg/kg = 1.05 mg in a 70kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.<br/>* Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/2 of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.
design_group_title: THC
design_group_type: Active Comparator
design_group_description: • Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Yale University
Collaborators: National Institute on Drug Abuse
Drug name mappings:
name: 屈大麻酚
lang: CN
name: Dronabinol
lang: EN
Clinical trial NCT02766270: CCRT With Temozolomide Versus RT Alone in Patients With IDH Wild-type/TERT Promoter Mutation Grade II/III Gliomas
Official title: A Prospective Study of Concurrent Chemoradiotherapy With Temozolomide Versus Radiation Therapy Alone in Patients With IDH Wild-type/TERT Promoter Mutation Grade II/III Gliomas
Conditions: Grade II/III Glioma
Summary: The management of lower-grade gliomas (Diffuse low-grade and intermediate-grade gliomas, WHO II and III) is largely based on surgery followed by radiotherapy. Recent studies showed that lower-grade glioma patients with IDH wild-type (IDH-wt) and TERT promoter mutation (TERTp-mut) had dismal clinical outcomes. These results suggested that current treatment strategies are not adequate for this subtype of lower-grade glioma.
The present study aims to examine the efficacy and safety of concurrent chemoradiotherapy with temozolomide followed by adjuvant temozolomide for lower- grade glioma patients with IDH-wt and TERTp-mut.
Interventions:
description: RT with daily temozolomide (75 mg/m2/day, 7 days/week for up to 7 weeks) and adjuvant temozolomide (150-200 mg/m2 PO QD for 5 days, repeats every 28 days for up to 12 courses).
name: Temozolomide
type: Drug
name: Radiotherapy
type: Radiation
Study arms:
design_group_description: Patients undergo intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy 5 days a week for 6 weeks (for a total of 60 Gy) and receive temozolomide PO QD (75 mg/m2/day, 7 days/week) for up to 7 weeks. Beginning 4 weeks after completion of chemotherapy and radiation therapy, patients receive temozolomide PO QD on days 1-5 (150-200 mg/m2). Treatment with temozolomide repeats every 28 days for up to 12 courses
design_group_title: Chemoradiotherapy with Temozolomide
design_group_type: Experimental
design_group_description: Patients undergo intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy 5 days a week for 6 weeks (for a total of 60 Gy)
design_group_title: Radiotherapy alone
design_group_type: Active Comparator
Sponsor: Beijing Tiantan Hospital
Collaborators: Beijing Neurosurgical Institute
Capital University of Medical Sciences
Drug name mappings:
name: 替莫唑胺
lang: CN
name: Temozolomide
lang: EN
name: テモゾロミド
lang: JP
Clinical trial NCT03219047: Patient-Derived Xenografts in Personalizing Treatment for Patients With Relapsed/Refractory Mantle Cell Lymphoma
Official title: A Pilot Study Evaluating Xenografts to Personalize Therapies (PDX) in Relapsed Mantle Cell Lymphoma to Optimize Response: The EXPLORE Trial
Conditions: Recurrent Mantle Cell Lymphoma
Refractory Mantle Cell Lymphoma
Summary: This early phase I pilot trial studies how well patient-derived xenografts work in personalizing treatment for patients with mantle cell lymphoma that has come back (relapsed) or that isn't responding to treatment (refractory). Xenograft models involve taking a piece of tissue from a tumor that was previously collected and putting that tissue inside of a mouse in the laboratory. This allows the tumor to grow in the mouse so that researchers can test the effects of certain drugs. If the drugs have an effect on the tumor(s) in the mice, patients may receive that treatment for mantle cell lymphoma.
Interventions:
description: Receive standard of care
name: Best Practice
other_name: standard of care
standard therapy
type: Other
description: Given at standard dose and schedule
name: Ibrutinib
other_name: BTK Inhibitor PCI-32765
CRA-032765
Imbruvica
PCI-32765
type: Drug
description: Xenograft developed
name: Patient Derived Xenograft
other_name: PDTX
PDX
Patient-Derived Xenograft
Patient-Derived Xenograft Model
type: Other
description: Receive treatment based on the results of the PDX models
name: Personalized Medicine
type: Other
Study arms:
design_group_description: Patients receive ibrutinib at standard dose and schedule through an ongoing MD Anderson clinical trial. Patients that respond to ibrutinib but experience relapse or disease progression receive treatment based on the results of the PDX models as in Cohort 1 if they are available. Patients who experience relapse after treatment with ibrutinib are moved to Cohort I if the PDX models are not ready.
design_group_title: Cohort 2 (Co-trial cohort)
design_group_type: Experimental
design_group_description: Patients who have previously received ibrutinib, acalabrutinib, PI3K inhibitor ACP-319, or BTK inhibitor BGB-3111 receive treatment through ongoing clinical trials at MD Anderson or standard of care. At the same time, previously collected tissue is used to develop PDX models and suitable drugs/regimens are tested in the PDX models. Patients then receive treatment based on the results of the PDX models through another clinical trial or standard of care.
design_group_title: Cohort I (Traditional cohort)
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 伊布替尼
lang: CN
name: Ibrutinib
lang: EN
name: イブルチニブ
lang: JP
Clinical trial NCT03493178: Glutathione in Mild Cognitive Impairment
Official title: Glutathione in Mild Cognitive Impairment
Conditions: Mild Cognitive Impairment
Summary: Elderly humans have an increased risk of dementia which begins as mild defects in memory called mild cognitive impairment. Glutathione (GSH), a key endogenous antioxidant has been linked to cognition. This exploratory study will investigate mechanisms linked to GSH for cognitive impairment (and improvement) by studying humans with mild cognitive impairment who will be evaluated 12-weeks after receiving either N-acetylcysteine and glycine (GSH precursors), or receiving alanine, and a further 12-weeks after stopping these supplements.
Interventions:
description: Dietary Supplement: glycine will be supplemented in the active arm for 12-weeks
name: Glycine
type: Dietary Supplement
description: Dietary Supplement: NAC will be supplemented in the active arm for 12-weeks
name: N-acetylcysteine (NAC)
type: Dietary Supplement
description: Dietary Supplement: Alanine will be supplemented in the placebo arm for 12-weeks
name: Alanine
type: Dietary Supplement
Study arms:
design_group_description: 30 Subjects with MCI will receive N-acetylcysteine and glycine for 12-weeks. ll subjects will be studied at baseline prior to supplementation, after completing 12-weeks of supplementation, and 12-weeks after stopping supplementation (i.e. at 24-weeks). Supplements are only provided for first 12-weeks.
design_group_title: MCI-active
design_group_type: Active Comparator
design_group_description: 30 subjects will received alanine for 12-weeks. All subjects will be studied at baseline prior to supplementation, after completing 12-weeks of supplementation, and 12-weeks after stopping supplementation (i.e. at 24-weeks). Supplements are only provided for first 12-weeks
design_group_title: MCI-placebo
design_group_type: Placebo Comparator
Sponsor: Baylor College of Medicine
Collaborators: The Methodist Hospital Research Institute
Drug name mappings:
name: 甘氨酸
lang: CN
name: Glycine
lang: EN