PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT00889460: Safety and Tolerability Study of rBet v1 SLIT Tablets
Official title: Phase I Study to re-Investigate the Safety, Tolerability and Pharmacodynamic Effects of SLIT(Tablets) With Recombinant Bet v1 Given in Single Rising Doses and in Multi Dose Regimens to Subjects Sensitised to Birch Pollen
Conditions: Birch Pollen-Related Rhinoconjunctivitis
Rhinitis, Allergic, Seasonal
Summary: The purpose of this study is to determine the safety and tolerability of several doses of r Bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen.
Interventions:
description: Two tablets (1 placebo + 1 rBet v 1 or 2 rBet v 1) were administered every day over 2 weeks with a 2-day break for the week-end. Administered doses ranged from 12.5 to 100 µg rBet v 1.
name: rBet v 1
other_name: rBet v 1.0101
type: Biological
description: Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.
name: Placebo
type: Biological
Study arms:
design_group_description: Placebo group
design_group_title: 1
design_group_type: Placebo Comparator
design_group_description: rBet v 1 tablets
design_group_title: 2
design_group_type: Experimental
Sponsor: Stallergenes Greer Ltd.
Collaborators: Quintiles, Inc. (California)
Drug name mappings:
name: Birch pollen allergen product(Stallergenes GmbH)
lang: EN
Clinical trial NCT03881488: Study of CTX-471 as a Monotherapy or in Combination With Pembrolizumab in Patients Post PD-1/PD-L1 Inhibitors in Metastatic or Locally Advanced Malignancies
Official title: A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-471 Administered Either as a Monotherapy or in Combination With Pembrolizumab in Patients With Inadequate Responses to PD-1/PD-L1 Checkpoint Inhibitors in Metastatic or Locally Advanced Malignancies
Conditions: Locally Advanced Solid Tumor
Metastatic Cancer
Non-small Cell Lung Cancer
Small Cell Lung Cancer
Mesothelioma
Melanoma
Head and Neck Cancer
Summary: This is a Phase 1, open-label, first-in-human study of CTX-471 administered as a monotherapy or in combination with pembrolizumab in patients with metastatic or locally advanced malignancies that have progressed while receiving an approved PD-1 or PD-L1 inhibitor. The study will be conducted in 2 treatment arms (Monotherapy Arm 1 and Combination Arm 2). Each arm will have two parts: Part 1 Dose Escalation and Part 2 Dose Expansion.
Interventions:
description: IV infusion every 2 weeks
name: CTX-471
type: Drug
description: IV infusion every 6 weeks
name: Pembrolizumab (KEYTRUDA®)
other_name: KEYTRUDA®
type: Drug
Study arms:
design_group_description: Escalating doses of CTX-471 depending on cohort at enrollment
design_group_title: Arm 1 Part 1 Dose Escalation
design_group_type: Experimental
design_group_description: Two dose groups of CTX-471 (0.3 mg/kg and 0.6 mg/kg)
design_group_title: Arm 1 Part 2 Dose Expansion
design_group_type: Experimental
design_group_description: Escalating doses of CTX-471 in combination with pembrolizumab (KEYTRUDA® ) depending on cohort at enrollment
design_group_title: Arm 2 Part 1 Dose Escalation
design_group_type: Experimental
design_group_description: Two cohorts of CTX-471 (0.3 mg/kg and 0.6 mg/kg) in combination with pembrolizumab (KEYTRUDA® ) (400 mg) in three tumor type subgroups. Cohort 1 - Group 1A - NSCLC , Group 1B -SCLC and Group 1C - Melanoma. Cohort 2 Group 2A - NSCLC, Group 2B - SCLC and Group 2C -Melanoma.
design_group_title: Arm 2 Part 2 Dose Expansion
design_group_type: Experimental
Sponsor: Compass Therapeutics, Inc.
Collaborators: IQVIA Holdings, Inc.
Drug name mappings:
name: CTX-471
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
Clinical trial NCT00058578: Stem Cell Transplant to Treat Patients With Systemic Sclerosis
Official title: Autologous T-Cell Depleted Peripheral Blood Stem Cell Transplantation for the Treatment of Selected Patients With Systemic Sclerosis
Conditions: Systemic Sclerosis
Summary: Systemic Sclerosis is a disease that may be caused by the immune system reacting against skin and certain organs. It is possible, that by changing the immune system we can modify the progression of this disease.
Stem cells are created in the bone marrow. They mature into different types of blood cells that are needed including red blood cells, white blood cells, and platelets. In this study, we will stimulate the bone marrow to make extra stem cells. Next we will collect the stem cells, select specific cells, and store them. We will then give high dose chemotherapy that will destroy the patients immune system. We will then give back the selected stem cells we collected. We believe that these selected stem cells may be able to "re-create" the immune system without the portion that causes Systemic Sclerosis.
The purpose of this study is to try to discover if stem cell transplantation can help patients with Systemic Sclerosis. We will also try to learn what the side effects are of this treatment in patients with Systemic Sclerosis. We hope that this treatment will help to relieve the symptoms patients are experiencing, although we do not know if it will.
Interventions:
name: Cyclophosphamide
type: Drug
name: Mesna
type: Drug
name: G-CSF
type: Drug
name: Leukopheresis
type: Procedure
name: Total Body Irradiation
type: Procedure
Study arms:
Sponsor: Baylor College of Medicine
Collaborators: Center For Cell & Gene Therapy
The Methodist Hospital Research Institute
Drug name mappings:
name: 美司钠
lang: CN
name: Mesna
lang: EN
name: メスナ
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: 非格司亭 （安进）
lang: CN
name: Filgrastim (Amgen)
lang: EN
name: フィルグラスチム（遺伝子組換え）
lang: JP
Clinical trial NCT05657184: Treatment of Idiopathic Pulmonary Fibrosis (IPF) by REGEND001
Official title: An Open-label Clinical Study to Explore the Safety, Tolerability and Preliminary Efficacy of REGEND001 for Treatment of Idiopathic Pulmonary Fibrosis (IPF).
Conditions: Idiopathic Pulmonary Fibrosis
Summary: Idiopathic pulmonary fibrosis (IPF) is a condition where the lungs are damaged and scarred with unknown reason, making breathing becomes increasingly difficult.. REGEND001, made from airway basal cells with ability to regenerate lung tissue, is promising to IPF treatment. In this study, a single-armed clinical trial is ongoing to assess the safety and tolerability of REGEND001 in treatment of IPF. Different doses of REGEND001 is evaluated to establish a dose-response relationship and to suggest appropriate dose for subsequent clinical trials.
Interventions:
description: Transplantation of REGEND001 for dose escalation.
name: REGEND001
type: Drug
Study arms:
design_group_description: Transplantation of autologous airway basal cells
design_group_title: REGEND001
design_group_type: Experimental
Sponsor: Regend Therapeutics Co. Ltd.
Collaborators: Ruijin Hospital
Peking Union Medical College Hospital
The First Affiliated Hospital of Guangzhou Medical University
Drug name mappings:
name: REGEND001细胞自体回输制剂
lang: CN
name: Pulmovinci
lang: EN
Clinical trial NCT04782076: A Drug Drug Interaction (DDI) Study of Selpercatinib and Dabigatran in Healthy Participants
Official title: An Open-Label Study to Investigate the Effect of Selpercatinib on the Pharmacokinetics of Dabigatran in Healthy Volunteers
Conditions: Healthy
Summary: The main purpose of this study is to determine the effect of selpercatinib on the levels of dabigatran in the blood stream and how long it takes the body to remove dabigatran. This study will also look at how safe and well-tolerated of dabigatran when administered in combination with selpercatinib in healthy participants. This study will last approximately 22 to 25 days.
Interventions:
description: Administered orally.
name: Dabigatran
type: Drug
description: Administered orally.
name: Selpercatinib
other_name: LY3527723
type: Drug
Study arms:
design_group_description: Participants received a single oral dose of 150 milligrams (mg) dabigatran on Day 1 and a single oral dose of 150 mg dabigatran coadministered with a single oral dose of 2 x 80 mg (160 mg) selpercatinib on Day 8.<br/>There was a washout period of 7 days between dosing on Days 1 and 8.
design_group_title: Dabigatran + Selpercatinib
design_group_type: Experimental
Sponsor: Loxo Oncology, Inc.
Collaborators: Eli Lilly & Co.
Drug name mappings:
name: 塞普替尼
lang: CN
name: Selpercatinib
lang: EN
name: セルペルカチニブ
lang: JP
name: 甲磺酸达比加群酯
lang: CN
name: Dabigatran Etexilate Mesylate
lang: EN
name: ダビガトランエテキシラートメタンスルホン酸塩
lang: JP
Clinical trial NCT00648128: Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fed State
Official title: Single Dose Crossover Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Healthy Male and Female Volunteers / Fed State
Conditions: Healthy
Summary: The objective of this study was to investigate the bioequivalence of Genpharm's clarithromycin tablets following a single, oral 500 mg (1 x 500 mg) dose compared to the Biaxin® filmtab® (Abbott Laboratories USA) administered under fed conditions. Forty-four (44) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were randomized, in this two-period, two-treatment crossover bioequivalence study conducted by Eric Sicard, M.D. at Algorithme Pharma Inc. Montreal, Canada.
Statistical analysis of the data reveals that 90% confidence intervals are within the acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters AUCT, AUCI and Cmax. This study demonstrates that Genpharm's clarithromycin 500 mg tablets are bioequivalent to Biaxin® filmtab® 500 mg tablets (Abbott Laboratories USA) administered under fed conditions.
Interventions:
description: Single-dose 500 mg immediate-release oral tablet
name: Clarithromycin
type: Drug
description: single-dose 500 mg immediate-release oral dose'
name: Clarithromycin
other_name: Biaxin® , Biaxin® Filmtabs
type: Drug
Study arms:
design_group_title: 2
design_group_type: Active Comparator
design_group_title: 1
design_group_type: Experimental
Sponsor: Mylan Pharmaceuticals, Inc.
Collaborators: Genpharm ULC
Drug name mappings:
name: 克拉霉素
lang: CN
name: Clarithromycin
lang: EN
name: クラリスロマイシン
lang: JP
Clinical trial NCT05963217: Study of TBI-2001(Autologous CD19 Specific Chimeric Antigen Receptor (CAR) Gene-transduced T Lymphocytes) for Relapsed or Refractory CD19+ B-cell Lymphoma, CLL/SLL
Official title: Phase I/Ib Study of TBI-2001 for Patients With Relapsed or Refractory CD19+ B-cell Lymphoma, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
Conditions: Relapsed or Refractory CD19+ B-cell Lymphoma
Relapsed or Refractory Chronic Lymphocytic Leukemia
Relapsed or Refractory Small Lymphocytic Lymphoma
Summary: This is a Phase 1/1b, open-label, dose-escalation study to evaluate the safety and the efficacy of anti-CD19 chimeric antigen receptor (CAR) (TBI-2001) for relapsed or refractory CD19+ B-cell lymphoma Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL).
Interventions:
description: Phase-I portion:<br/>cohort 1: 3×10^5 cells/kg, cohort 2: 1×10^6 cells/kg, cohort 3: 3×10^6 cells/kg). Phase-Ib portion: The dose of Phase-Ib will be determined during the phase I portion.
name: TBI-2001
type: Biological
description: IV Cyclophosphamide (for 3 days) will be administered as conditioning before cell infusion with TBI-2001.
name: Cyclophosphamide
type: Drug
description: IV Fludarabine (for 3 days) will be administered as conditioning before cell infusion with TBI-2001.
name: Fludarabine
type: Drug
Study arms:
design_group_description: 0.3 to 3 x 10^6 autologous CD19-CAR-T cells/kg per patient will be administered intravenously after a conditioning chemotherapy with cyclophosphamide and fludarabine.
design_group_title: Experimental: Dose Level 1 to 3
design_group_type: Experimental
Sponsor: University Health Network
Collaborators: Takara Bio, Inc.
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: TBI-2001
lang: EN
Clinical trial NCT01585181: Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200
Official title: A Phase 1 Randomized, Double-Blind Placebo Controlled Study to Evaluate the Safety and Immunogenicity of the LIve Oral Cholera Vaccine Candidate PXVX0200 Vibrio Cholerae Serotype 01 Inaba CVD 103-HgR Vaccine Strain
Conditions: Cholera
Summary: The purpose of this study is to compare the safety and immunogenicity of a single dose of the PXVX0200 live cholera vaccine versus placebo in volunteers (Vaccinees) and whether PXVX0200, which is a live attenuated bacteria, can be transmitted to other adults living in the same household.
Interventions:
description: Single dose; liquid suspension after reconstitution with buffer; 2x108 to 2x109 CFU in a liquid suspension
name: PXVX0200
type: Biological
description: Approx 2 grams of lactose reconstituted in water
name: Placebo
type: Biological
Study arms:
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_title: PXVX0200
design_group_type: Experimental
Sponsor: Bavarian Nordic A/S
Collaborators: Emergent BioSolutions, Inc.
Drug name mappings:
name: 活霍乱疫苗
lang: CN
name: Cholera Vaccine Live Oral(Emergent Travel Health)
lang: EN
Clinical trial NCT05414786: A Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644)
Official title: A Phase 1 Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) in HIV-1 Uninfected Adults in Good General Health
Conditions: HIV-1-infection
Summary: A Phase 1 Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) in HIV-1 Uninfected Adults in Good General Health.
Interventions:
description: * 2 doses eOD-GT8 60mer mRNA Vaccine (100µg), 2 vaccinations, 8 weeks apart<br/>* No control group. There is no blinding and no randomization in this open label study
name: eOD-GT8 60mer mRNA Vaccine (100µg)
type: Biological
Study arms:
design_group_description: * 2 doses eOD-GT8 60mer mRNA Vaccine (100µg), 2 vaccinations, 8 weeks apart<br/>* No control group. There is no blinding and no randomization in this open label study
design_group_title: Experimental group
design_group_type: Experimental
Sponsor: International AIDS Vaccine Initiative, Inc.
Collaborators: The Aurum Institute
ModernaTX, Inc.
Center For Family Health
Drug name mappings:
name: mRNA-1644
lang: EN
Clinical trial NCT07232420: A Study of BL-M24D1 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer and Other Solid Tumors
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M24D1 for Injection in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer and Other Solid Tumors
Conditions: Non Small Cell Lung Cancer
Solid Tumor
Summary: This study is an open, multicenter, non-randomized phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M24D1 in patients with locally advanced or metastatic non-small cell lung cancer and other solid tumors.
Interventions:
description: Administration by intravenous infusion for a cycle of 2 weeks.
name: BL-M24D1
type: Drug
Study arms:
design_group_description: Participants receive BL-M24D1 as intravenous infusion for the first cycle (2 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
design_group_title: BL-M24D1
design_group_type: Experimental
Sponsor: Sichuan Baili Pharmaceuticals Co.,Ltd
Collaborators: Baili Bio Chengdu Pharmaceutical Co. Ltd.
Drug name mappings:
name: BL-M24D1
lang: EN
Clinical trial NCT03498222: Study in Patients With Tumours Requiring Arginine to Assess ADI-PEG 20 With Atezolizumab, Pemetrexed and Carboplatin
Official title: Phase I Study in Patients With Tumours Requiring Arginine to Assess ADI-PEG 20 With Atezolizumab, Pemetrexed and Carboplatin (ADIAtezoPemCarbo) (iTRAP Study)
Conditions: Carcinoma, Non-Small-Cell Lung
Summary: iTRAP is an open-label, multi-centre, dose escalation study of ADI PEG20 in combination with atezolizumab, pemetrexed and carboplatin in patients with advanced non-squamous non-small cell lung carcinoma (NSCLC) - stage IIIB/IV.
Interventions:
description: Administered at a fixed dose of 1200 mg (equivalent to an average body weight-based dose of 15mg/kg) by intravenous (IV) infusion every 3 weeks (21 days).
name: Atezolizumab
other_name: Tecentriq
type: Drug
description: Administered at a fixed dose of 500mg/m2 by IV infusion every 3 weeks.
name: Pemetrexed
other_name: Alimta
type: Drug
description: Administered at a fixed dose of AUC5 by IV infusion every 3 weeks.
name: Carboplatin
type: Drug
description: Administered by intramuscular (IM) injection to patients once weekly.
name: ADI PEG20
type: Drug
Study arms:
design_group_description: Atezolizumab 1200mg Pemetrexed 500mg/m2 Carboplatin AUC5 ADI PEG20 9mg/m2
design_group_title: Dose Level -1
design_group_type: Experimental
design_group_description: Atezolizumab 1200mg Pemetrexed 500mg/m2 Carboplatin AUC5 ADI PEG20 18mg/m2
design_group_title: Dose Level 1
design_group_type: Experimental
design_group_description: Atezolizumab 1200mg Pemetrexed 500mg/m2 Carboplatin AUC5 ADI PEG20 36mg/m2
design_group_title: Dose Level 2
design_group_type: Experimental
Sponsor: Queen Mary University of London
Collaborators: Polaris Group
Hoffmann-La Roche, Inc.
Drug name mappings:
name: 卡铂
lang: CN
name: Carboplatin
lang: EN
name: カルボプラチン
lang: JP
name: 培美曲塞二钾
lang: CN
name: Pemetrexed Dipotassium
lang: EN
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: Pegargiminase
lang: EN
Clinical trial NCT03661125: SRC Inhibition as a Potential Target for Parkinson's Disease Psychosis
Official title: A Randomised, Balanced, Double-blind Two-way Crossover Design Study to Evaluate the Effects of SRC Kinase Inhibitor, Saracatinib, on Brain Activity Associated With Visual Processing in Patients With Parkinson's Disease Psychosis.
Conditions: Parkinson Disease Psychosis
Summary: Parkinson's disease is often characterised by movement symptoms such as rigidity and bradykinesia, however, there are a number of non-motor symptoms that can have a significant impact on quality of life. One of the most common non-motor symptoms of Parkinson's disease is visual hallucinations (where someone sees things that don't exist outside their mind). . Recent findings led to the approval of a drug called Pimavanserin as a treatment for PD psychosis in the USA. Based on other recent studies, we believe that Saracatinib, a drug that interacts within the same system as Pimavanserin, is a potential treatment for PD psychosis. Saracatinib has shown to reduce the intensity of the psychedelic effect induced by psilocybin (a naturally occurring psychedelic found in psilocybe mushrooms) and attenuate social cognition and brain changes in healthy volunteers. The aim of this study is to test the effects of 14 days dosing of saracatinib or placebo on 30 volunteers with PD psychosis. We aim to to use neuroimaging combined with psychopharmacology to provide evidence that a putative new treatment approach can modulate abnormal visual cortex activation in patients with PD psychosis. If positive, this proof of mechanism study would provide a strong platform to pursue symptom modification studies with Saracatinib.
Interventions:
description: AZD0530 (Saracatinib) 50 mg Tablet Pink Round 7.0 mm ADM P/5406/49. Two tablets to be taken every morning for 14 days.
name: Saracatinib
type: Drug
description: Placebo AZD0530 (Saracatinib) 50 mg Tablet Pink Round 7.0 mm ADM P/5406/37. Two tablets to be taken every morning for 14 days.
name: Placebo Oral Tablet
type: Drug
Study arms:
design_group_description: In the first arm of the study, participants will be randomised into either the group that receives Saracatinib (study drug) or the Placebo.
design_group_title: Saracatinib or placebo
design_group_type: Experimental
design_group_description: The groups will now cross over i.e. the group that had the study drug in the first arm will get the placebo in the second arm and the group that had the placebo in the first arm will have the study drug in the second arm.
design_group_title: Placebo or Saracatinib (Cross-over)
design_group_type: Experimental
Sponsor: King's College London
Collaborators: King's College Hospital NHS Foundation Trust
AstraZeneca PLC
Drug name mappings:
name: 塞卡替尼
lang: CN
name: Saracatinib
lang: EN
Clinical trial NCT07421102: Pilot of Mailing Buprenorphine
Official title: A Pragmatic Remote Approach to Improve Transitions of Care and Retention in Opioid Use Disorder Treatment
Conditions: Opioid Use Disorder
Summary: This pilot study evaluates the feasibility, acceptability, and preliminary effectiveness of mailing buprenorphine to individuals with opioid use disorder (OUD) following medical hospitalization. The intervention aims to improve retention in treatment by overcoming barriers such as transportation and pharmacy access.
Interventions:
description: This study examines the feasibility and preliminary effectiveness of mailing buprenorphine to overcome barriers such as transportation to obtaining buprenorphine from a pharmacy.
name: strategy of mailing buprenorphine
type: Other
Study arms:
design_group_description: There is no comparison arm. This pilot study evaluates the feasibility of mailing medications to patients.
design_group_title: Mailed Medications
design_group_type: Other
Sponsor: The Medical University of South Carolina
Collaborators: National Institute on Drug Abuse
Drug name mappings:
name: 盐酸丁丙诺啡
lang: CN
name: Buprenorphine Hydrochloride
lang: EN
name: ブプレノルフィン塩酸塩
lang: JP