PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT04218409: Opioid-Sparing and Pain-Reducing Properties of Syntocinon: A Dose-Effect Determination
Official title: Opioid-Sparing and Pain-Reducing Properties of Syntocinon: A Dose-Effect Determination
Conditions: Pain
Summary: Some research suggests that administration of oxytocin with oxycodone may reduce its abuse liability and improve its ability to reduce pain. In a 6-session laboratory study, the investigators will be evaluating the effects of oxycodone and oxytocin (combined and separately, across sessions) on experimentally-induced pain, subjective effects, decision-making, and activation of different neural substrates.
Interventions:
description: Oral oxycodone 5 mg orally
name: OxyCODONE 5 mg Oral Tablet
type: Drug
description: Intranasal oxytocin administration (48 IU)
name: Oxytocin nasal spray
type: Drug
description: Oxycodone 0 mg orally
name: Placebo Oxycodone
type: Other
description: Intranasal placebo administration
name: Placebo oxytocin
type: Other
description: Oral oxycodone 2.5 mg orally
name: OxyCODONE 2.5 mg Oral Tablet
type: Drug
Study arms:
design_group_description: Combined effects of oxycodone and oxytocin
design_group_title: oxycodone (5mg) + intranasal oxytocin (48 IU)
design_group_type: Active Comparator
design_group_description: Separate effects of oxycodone. As is standard methodology in abuse liability and pain assessments a placebo condition will be included for each drug in order to compare the abuse liability and pain assessments change from placebo
design_group_title: Oral oxycodone (5mg) + intranasal placebo
design_group_type: Active Comparator
design_group_description: Separate effects of oxytocin. As is standard methodology in abuse liability and pain assessments a placebo condition will be included for each drug in order to compare the abuse liability and pain assessments change from placebo
design_group_title: oxytocin+placebo
design_group_type: Active Comparator
design_group_description: Serves as the control
design_group_title: placebo+placebo
design_group_type: Sham Comparator
design_group_description: Combined effects of oxycodone and oxytocin
design_group_title: Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)
design_group_type: Active Comparator
design_group_description: Separate effects of oxycodone. As is standard methodology in abuse liability and pain assessments a placebo condition will be included for each drug in order to compare the abuse liability and pain assessments change from placebo
design_group_title: Oral oxycodone (2.5mg) + intranasal placebo
design_group_type: Active Comparator
Sponsor: University of Florida
Collaborators: National Institute on Drug Abuse
Drug name mappings:
name: 盐酸羟考酮
lang: CN
name: Oxycodone Hydrochloride
lang: EN
name: オキシコドン塩酸塩水和物
lang: JP
name: 缩宫素
lang: CN
name: Oxytocin
lang: EN
name: オキシトシン
lang: JP
Clinical trial NCT00825591: Biological Clock Dysfunction in Optic Nerve Hypoplasia
Official title: Identification and Treatment of Biological Clock Dysfunction in Optic Nerve Hypoplasia
Conditions: Biological Clock Dysfunction
Optic Nerve Hypoplasia
Summary: Background: Optic Nerve Hypoplasia (ONH) is a leading cause of blindness in children. For unclear reasons, the incidence of ONH is increasing, with ONH affecting about 1 in 10,000 live-born infants. In addition to visual deficits, ONH is associated with varying degrees of hypopituitarism, developmental delay, brain malformations and obesity. Although genetic mutations have been rarely observed to result in ONH, the causes of ONH are largely not known. In limited anatomical observations, the suprachiasmatic nuclei (SCN) located in the anterior hypothalamus, which generate circadian rhythms, have been observed to be abnormal in children with ONH. Thus, children with ONH may have biological clock dysfunction.
In collaborative studies with Dr. Mark Borchert of Childrens Hospital Los Angeles (CHLA), we have recently discovered that one-half of children with ONH have grossly abnormal sleep-wake patterns, as assessed by actigraphy. Although not known for children with ONH, abnormal sleep-wake patterns have been observed to be associated with neurocognitive impairment and obesity. We also observe that nocturnal melatonin administration can improve abnormal sleep-wake cycles in these children, raising the possibility that it will be possible to treat abnormal rhythmicity in children with ONH.
Interventions:
description: Oral administration before bed. We will test two doses (0.5 or 3.0 mg/m2. 6 week duration.)
name: Melatonin
type: Dietary Supplement
description: Oral administration before bed. 6 week duration.
name: Placebo Comparator
type: Dietary Supplement
Study arms:
design_group_description: Individuals with abnormal rhythmicity will be treated with melatonin to assess if sleep patterns are improved.
design_group_title: 1
design_group_type: Active Comparator
design_group_title: 2
design_group_type: Placebo Comparator
Sponsor: Yale University
Collaborators: Children's Hospital Los Angeles
Drug name mappings:
name: 褪黑素
lang: CN
name: Melatonin
lang: EN
name: メラトニン
lang: JP
Clinical trial NCT07079631: A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment BNT327 and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer
Official title: A Phase I/II, Randomized, Multi-site Trial to Investigate the Efficacy and Safety of BNT314 in Combination With BNT327 and Chemotherapy in Participants With Metastatic Colorectal Cancer
Conditions: Metastatic Colorectal Cancer
Summary: This randomized, multi-site, three-part study will test a new treatment called BNT314, which is designed to help the body's immune system fight cancer in combination with another new treatment (BNT327, which is an immune checkpoint inhibitor) and chemotherapy in participants with metastatic colorectal cancer (mCRC).
This study will enroll participants with microsatellite stable or mismatch repair proficient (MSS/pMMR) mCRC who did not respond well to their first schema of chemotherapy. In one part of the study (i.e., Part B) mCRC participants will be enrolled, who have not received any systemic therapy before for their cancer.
Interventions:
description: Intravenous (IV) infusion
name: BNT314
type: Biological
description: IV infusion
name: BNT327
type: Drug
description: IV infusion / IV bolus
name: SoC chemotherapy treatment 1
type: Drug
description: IV infusion / IV bolus / oral
name: SoC chemotherapy treatment 2
type: Drug
description: IV infusion
name: Bevacizumab
type: Drug
Study arms:
design_group_description: Up to 5 dose levels of BNT314. One or two dose levels of BNT327.
design_group_title: Phase 1 (Part A): BNT314 (escalating dose levels) + BNT327
design_group_type: Experimental
design_group_description: BNT314 (optimized dose level 1 or 2 as determined based on data from Part A) + BNT327 + SoC combination chemotherapy 1.<br/>One selected dose level of BNT327.
design_group_title: Phase 1 (Part B): BNT314 + BNT327 + SoC chemotherapy 1
design_group_type: Experimental
design_group_description: BNT314 (optimized dose level 1 or 2 as determined based on data from Part A) + BNT327 + SoC combination chemotherapy 2.<br/>One selected dose level of BNT327.
design_group_title: Phase 1 (Part B): BNT314 + BNT327 + SoC chemotherapy 2
design_group_type: Experimental
design_group_description: Recommended phase 2 dose of BNT314 + BNT327 + SoC combination chemotherapy 1. One selected dose level of BNT327.
design_group_title: Phase 2 (Part C): BNT314 + BNT327 + SoC chemotherapy 1
design_group_type: Experimental
design_group_description: Combination of two different SoC therapies
design_group_title: Phase 2 (Part C): Bevacizumab + SoC chemotherapy 1
design_group_type: Active Comparator
design_group_description: BNT327 + SoC combination chemotherapy 1. One selected dose level of BNT327.
design_group_title: Phase 2 (Part C): BNT327 + SoC chemotherapy 1
design_group_type: Experimental
Sponsor: BioNTech SE
Collaborators: Genmab A/S
Drug name mappings:
name: 普密妥米单抗
lang: CN
name: Pumitamig
lang: EN
name: DuoBody-EpCAMx4-1BB
lang: EN
Clinical trial NCT06370598: Phase 1/2a to Assess the Safety and Tolerability of TP-122A for the Treatment of Ventilator-Associated Pneumonia
Official title: A Randomized, Parallel, Open-Label, Phase 1/2a Study to Assess the Safety and Tolerability of Multiple Doses of the Bacteriophage Cocktail TP-122 (Component TP-122A), for the Treatment of Ventilator-Associated Pneumonia
Conditions: Pneumonia, Ventilator-Associated
Summary: Given the challenges of treating complex cases of VAP caused by P. aeruginosa and K. pneumoniae, TechnoPhage developed a bacteriophage cocktail (TP-122) against those pathogens, aiming to provide a hospital-based add-on therapy to the SoC including antibiotic therapy, administered by nebulization. TP-122 is a bacteriophage cocktail divided in two different components: TP-122A is comprised of three bacteriophages against infections caused by Pseudomonas aeruginosa and TP-122B includes three bacteriophages against K. pneumoniae . For this study, an effective sample of 15 subjects will be randomly allocated into two arms, in a 3:2 ratio, with 9 subjects receiving TP-122A, in addition to SoC, and 6 subjects receiving the SoC alone.
Interventions:
description: Bacteriophage cocktail targeting Psa
name: TP-122A
type: Biological
Study arms:
design_group_description: Enrolled subjects in the TP-122A+SoC arm will receive IP every 8 hours for 7 days by nebulization and will be followed-up for 28 days after the last IP administration.
design_group_title: TP-122A with SOC
design_group_type: Experimental
design_group_description: Just standard of care will be given to patient
design_group_title: SOC alone
design_group_type: No Intervention
Sponsor: TechnoPhage SA
Collaborators: Vectorb2B
Drug name mappings:
name: Bacteriophage Cocktail(TechnoPhage SA)
lang: EN
Clinical trial NCT04116658: First-in-Human, Phase 1b/2a Trial of a Multipeptide Therapeutic Vaccine in Patients With Progressive Glioblastoma
Official title: A Multicenter, Open-Label, First-in-Human, Phase 1b/2a Trial of EO2401, a Novel Multipeptide Therapeutic Vaccine, With and Without Check Point Inhibitor, Following Standard Treatment in Patients With Progressive Glioblastoma
Conditions: Glioblastoma, Adult
Summary: The purpose of this study is to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2401 in patients with unequivocal evidence of progressive or first recurrent glioblastoma.
Interventions:
description: Multiple dose administration of EO2401 coadministered with or without nivolumab (and bevacizumab, US only) during the priming phase
name: Multiple dose of EO2401
type: Biological
Study arms:
design_group_description: Multiple dose of EO2041 monotherapy followed by continued EO2401 in combination with nivolumab
design_group_title: Cohort 1
design_group_type: Experimental
design_group_description: Multiple dose of EO2041 in combination with nivolumab
design_group_title: Cohort 2
design_group_type: Experimental
design_group_description: Multiple dose of EO2041 in combination with nivolumab and bevacizumab
design_group_title: Cohort 3
design_group_type: Experimental
Sponsor: Enterome SA
Collaborators: Labcorp Drug Development, Inc.
Drug name mappings:
name: Tindupepimut
lang: EN
Clinical trial NCT02734004: A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors.
Official title: A Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Olaparib (PARP Inhibitor) in Patients With Advanced Solid Tumors
Conditions: Ovarian
Breast
SCLC
Gastric Cancers
Summary: The purpose of this study is to look at the effectiveness, safety, and antitumor activity of study drugs MEDI4736 in combination with olaparib (modules 1, 2, 3, 4, 5 and 7) and MEDI4736 in combination with olaparib and bevacizumab (module 6). It will also examine what happens to the study drugs in the body and investigate how well the combination between MEDI4736, olaparib and bevacizumab is tolerated.
Interventions:
description: Olaparib
name: Olaparib
type: Drug
description: MEDI4736
name: MEDI4736
type: Drug
description: Bevacizumab
name: Bevacizumab
other_name: Avastin
type: Drug
Study arms:
design_group_description: Includes initial stage cohorts (modules 1 to 4): Olaparib twice daily starting on week 1 day 1 and MEDI4736 every 4 weeks starting on week 5 day 1
design_group_title: Arm 1
design_group_type: Experimental
design_group_description: Includes 2nd stage cohorts (modules 5 & 7): Olaparib twice daily starting on week 1 day 1 and MEDI4736 every 4 weeks starting on week 1 day 1
design_group_title: Arm 2
design_group_type: Experimental
design_group_description: Includes 2nd stage cohort (module 6): Olaparib twice daily starting on week 1 day 1 / MEDI4736 every 4 weeks starting on week 1 day 1 / Bevacizumab every 2 weeks starting on week 1 day 1
design_group_title: Arm 3
design_group_type: Experimental
Sponsor: AstraZeneca PLC
Collaborators: IQVIA Holdings, Inc.
Drug name mappings:
name: 奥拉帕利
lang: CN
name: Olaparib
lang: EN
name: オラパリブ
lang: JP
name: 贝伐珠单抗
lang: CN
name: Bevacizumab
lang: EN
name: ベバシズマブ（遺伝子組換え）
lang: JP
name: 度伐利尤单抗
lang: CN
name: Durvalumab
lang: EN
name: デュルバルマブ（遺伝子組換え）
lang: JP
Clinical trial NCT02408744: Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease
Official title: Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease
Conditions: Fibrosis
Chronic Kidney Disease
Summary: The aim of this study was to evaluate the impact in safety and efficacy of a new formulation of prolonged-released Pirfenidone in the progression of renal damage in patients with Chronic kidney Disease (CKD).
Interventions:
description: Pirfenidone was supplied orally in the form of prolonged-released tablets according with body surface area (m2 BS) of each patient. The target dosage of PFD was 1200 mg two times a day (b.i.d.) for a full dosage of 2400 mg daily during three years. Therapy was initiated at 600 mg b.i.d. and escalated to full dosage after 3 weeks when symptoms were controlled.
name: Pirfenidone
other_name: 5-methyl-1-phenyl-2-(1H)-pyridone
type: Drug
Study arms:
design_group_description: Pirfenidone 1200 mg in the form of prolonged-released tablets, orally administered two times a day (b.i.d.) to yield a daily dose of 2400 mg during three years.
design_group_title: Pirfenidone
design_group_type: Experimental
Sponsor: University of Guadalajara
Collaborators: Cell Therapy And Technology, S.a. De C.v.
Drug name mappings:
name: 吡非尼酮
lang: CN
name: Pirfenidone
lang: EN
name: ピルフェニドン
lang: JP
Clinical trial NCT05834296: Study in Subjects With Mild-to-Moderate Alzheimer's Dementia
Official title: Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 1/2a Study to Assess Safety, Tolerability & Efficacy of Autologous Beta-Amyloid Mutant Peptide-pulsed Dendritic Cells in Subjects With Mild-to-Moderate Alzheimer's Dementia
Conditions: Alzheimer Disease
Summary: ALZN002-01 is a first-in-human, randomized, double-blind, placebo-controlled, parallel-group, phase 1/2a study of autologous amyloid beta mutant peptide-pulsed dendritic cells (ALZN002) in subjects with mild-to-moderate dementia of the Alzheimer's type.
Interventions:
description: The cellular immunotherapy product consists of autologous dendritic cells (DCs) pulsed with a novel amyloid-beta peptide (Aβ1 42) containing a mutation at position 22 from glutamic acid to tryptophan (E22W). This mutation produces novel CD4+ T cell epitopes specific for the mutant E22W peptide that can facilitate an anti-Aβ1-42 antibody response. The activated E22W peptide specific CD4+ T cells license Aβ1-42-specific B cells to secrete anti Aβ1-42 antibodies, resulting in systemic reduction of amyloid and reduction or slowed accumulation of amyloid plaques in the brain.
name: ALZN002 (autologous DCs pulsed with E22W mutant peptide).
type: Biological
description: Saline
name: Placebo
type: Drug
Study arms:
design_group_description: ALZN002 (autologous DCs pulsed with E22W mutant peptide).
design_group_title: Active
design_group_type: Experimental
design_group_description: Saline ID and IV administrations.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Alzamend Neuro, Inc.
Collaborators: Biorasi LLC
Drug name mappings:
name: ALZN002
lang: EN
Clinical trial NCT00809237: Hydroxychloroquine and Gefitinib to Treat Lung Cancer
Official title: A Phase II With a Lead in Phase I Study to Examine the Tolerability, Safety Profile and Efficacy of Hydroxychloroquine and Gefitinib in Advanced Non-Small Cell Lung Cancer
Conditions: Non-small Cell Lung Cancer
Summary: Non-small cell lung cancer (NSCLC) is the most common cause of cancer mortality in men and women in Singapore.Chemotherapy and biologically targeted agents can extend survival only modestly for these patients; therefore, discovery of novel ways to prolong the disease course is a top research priority.
The epidermal growth factor receptor (EGFR) signaling pathway plays a central role in the neoplastic transformation of NSCLC and promotes cancer cell survival, metastasis, and angiogenesis. The predominance of EGFR signaling in NSCLC makes the pathway an attractive candidate for the development of targeted therapeutics. Over the last three years, the FDA has approved two drugs for salvage treatment of NSCLC, gefitinib (Iressa ®, formerly known as ZD1839) and erlotinib (Tarceva ®, formerly known as OSI-774). Both are small molecule orally-bioavailable tyrosine kinase inhibitors (TKIs) of the EGFR TK domain, and have been shown to improve survival compared to placebo in asian patients when administered after failure of first or second line chemotherapy for advanced NSCLC.
Interventions:
description: Gefitinib 250 mg om Hydroxychloroquine at maximally tolerated dose
name: Gefitinib, Hydroxychloroquine
other_name: Iressa
type: Drug
Study arms:
design_group_description: For the lead in phase I study, recruited patients will receive one week of 250 mg of Gefitinib, before HCQ at the assigned dose is introduced in addition to Gefitinib 250 mg om.<br/>After the MTD of HCQ is determined, the phase II study will proceed with the combination of 250 mg of Gefitinib and the MTD dose of HCQ.
design_group_title: Gefitinib, Hydroxychloroquine
design_group_type: Experimental
Sponsor: National University Hospital
Collaborators: The General Hospital Corp.
AstraZeneca PLC
Drug name mappings:
name: 硫酸羟氯喹
lang: CN
name: Hydroxychloroquine Sulfate
lang: EN
name: ドロキシクロロキン硫酸塩
lang: JP
name: 吉非替尼
lang: CN
name: Gefitinib
lang: EN
name: ゲフィチニブ
lang: JP
Clinical trial NCT05460273: A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Breast Cancer and Other Solid Tumors (TROPION-PanTumor02)
Official title: Phase 1/2, Multicentre, Open-label, Multiple-cohort Study of Dato-DXd in Chinese Patients With Advanced Non-small-cell Lung Cancer, Triple-negative Breast Cancer, Gastric/Gastroesophageal Junction Cancer, Urothelial Cancer, and Other Solid Tumours (TROPION-PanTumor02)
Conditions: Carcinoma, Non-Small-Cell Lung
Triple Negative Breast Cancer
Summary: Researchers are looking for a better way to treat advanced Triple-Negative Breast Cancer (TNBC) and Non-Small-Cell Lung Cancer (NSCLC). "Advanced" usually means that the cancer keeps growing even with treatment. The cancer may also be "metastatic", which means that it has spread to other parts of the body or the surrounding tissue.
The study drug, Datopotamab deruxtecan, is designed to work by attaching to the tumor cells and stopping the tumor growth. Datopotamab deruxtecan is also known as Dato-DXd.
In this study, the researchers want to find out how well Dato-DXd works to stop tumors from growing in Chinese participants with NCSLC or TNBC. This is the first time Dato-DXd is being studied in Chinese population.
Participants in this study will get Dato-DXd through a needle as an injection. They will get 1 dose of Dato-DXd every 3 weeks until their cancer gets worse or they leave the study for another reason.
Participants will visit their study sites at least once every 3 weeks for as long as they are in the study. The study doctors will take blood samples every 3 weeks and take images of the participants' tumors every 6 weeks until the participant leaves the study.
Interventions:
description: Dato-DXd is an antibody-drug conjugate (ADC) that binds to TROP2.
name: Datopotamab Deruxtecan (Dato-DXd)
other_name: DS-1062a
type: Drug
Study arms:
design_group_description: This single-arm study consists of multiple cohorts, divided by indication.
design_group_title: Dato-DXd Arm
design_group_type: Experimental
Sponsor: AstraZeneca PLC
Collaborators: Daiichi Sankyo Co., Ltd.
Drug name mappings:
name: 德达博妥单抗
lang: CN
name: Datopotamab Deruxtecan
lang: EN
name: ダトポタマブ デルクステカン（遺伝子組換え）（JAN）
lang: JP
Clinical trial NCT04818203: A Study on the Anti-Wrinkle Efficacy Assessment and Safety Evaluation of the Cluster of Autologous Dermal Fibroblast on Bilateral Crow's Feet
Official title: A Single Center, Randomized, Evaluator and Subject Blind, Placebo Controlled, Parallel, Phase 1/2 Study for the Anti-wrinkle Efficacy Assessment and Safety Evaluation by Treating Cluster of Autologous Dermal Fibroblasts, 3D-F in Patients With Bilateral Crow's Feet
Conditions: Crow's Feet
Summary: This study is a phase 1/2 clinical trial to evaluate the safety and efficacy of administering clusters of autologous dermal fibroblasts to subjects with periorbital wrinkles on both sides.
If subjects who have signed the Informed consent form voluntarily are enrolled in this study, they will be tested for eligibility during the screening period. Subjects will visit the study site a total of 6 times while participating in this study. The subjects who meet the inclusion/exclusion criteria will receive a total of one dose of the IP (Visit 3). Then, the efficacy evaluation will be conducted at Visit 4 (Week 2), Visit 5 (Week 12), and Visit 6 (Week 24), and safety will also be evaluated at each visit.
Interventions:
description: Dose: 1 x 10^7 cells/1 mL/vial
name: Clusters of Autologous Dermal Fibroblasts
other_name: 3D-F
FECS-DF
type: Biological
description: The injection solution without clusters of autologous dermal fibroblasts
name: Placebo
type: Other
Study arms:
design_group_description: Participants receive 1 mL of clusters of autologous dermal fibroblast to three spots around the left eye and three spots around the right eye along the periorbital wrinkles on both sides, perpendicularly to the wrinkles.
design_group_title: Test Group
design_group_type: Experimental
design_group_description: Participants receive 1 mL of placebo solution to three spots around the left eye and three spots around the right eye along the periorbital wrinkles on both sides, perpendicularly to the wrinkles.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: S.Biomedics Co., Ltd.
Collaborators: Dt&SanoMedics Co. Ltd.
Drug name mappings:
name: Clusters of Autologous Dermal Fibroblasts(S.Biomedics)
lang: EN