PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT02906995: Pharmacokinetics of Nicotine Sublingual Tablets Versus Nicorette Lozenge in Healthy Smokers
Official title: An Open-Label Pseudorandomized, Two Way Crossover Comparison of the Single-Dose Pharmacokinetics of Nicotine 4 mg Sublingual Tablets Versus Nicorette Lozenge 4 mg in Healthy Smokers Under Fasted Conditions
Conditions: Tobacco Use Disorder
Cigarette Smoking
Summary: The purpose of the study is to compare two different dosage forms from which nicotine is released and absorbed into the bloodstream.
Interventions:
description: * One dose of study drug (sublingual tablet or Nicorette Lozenge) will be administered to each subject in the morning on Day 1.<br/>* The second administration of drug will occur at least 48 hours after the initial administration. Subjects will receive the other dosage form and be instructed according to whether they are receiving the sublingual tablet or the lozenge.
name: Sublingual tablet 4 mg versus Nicorette Lozenge 4mg
other_name: Pharmacokinetic comparison of two nicotine dosage forms
type: Drug
Study arms:
design_group_description: The 24 study participants will be administered the sublingual 4 mg nicotine tablet on one occasion. Blood samples will be obtained for 4 hours for analysis of nicotine plasma levels.
design_group_title: Sublingual tablet 4 mg
design_group_type: Experimental
design_group_description: The 24 study participants will be administered the Nicorette lozenge containing 4 mg of nicotine on one occasion. Blood samples will be obtained for 4 hours for analysis of nicotine plasma levels.
design_group_title: Nicorette lozenge 4 mg
design_group_type: Active Comparator
Sponsor: Friends Research Institute, Inc.
Collaborators: Rose Research Center LLC
Drug name mappings:
name: 尼古丁
lang: CN
name: Nicotine
lang: EN
Clinical trial NCT01052298: Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)
Official title: Randomized, Single-blinded, Placebo-controlled Study to Evaluate the Safety and Tolerability, the Pulmonary Deposition and Pharmacokinetics of Ciprofloxacin in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease (GOLD I - II), Following Inhalation of Ciprofloxacin PulmoSphere Inhalation Powder.
Conditions: Disease, Pulmonary
Summary: Objectives of the study are to investigate the safety, tolerability and levels of ciprofloxacin in the lung after single and multiple inhalative administration to patients with mild to moderate COPD (stage I-II according to GOLD Criteria).
Interventions:
description: 32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given twice daily (bid) with a concluding single dose on 11d.
name: Ciprofloxacin (Cipro inhale, BAYQ3939)
type: Drug
description: 32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given three times daily (tid) with a concluding single dose on 11d.
name: Ciprofloxacin (Cipro inhale, BAYQ3939)
type: Drug
description: 48.75 mg ciprofloxacin betaine corresponding to 75 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given twice daily (bid) with a concluding single dose on 11d.
name: Ciprofloxacin (Cipro inhale, BAYQ3939)
type: Drug
description: Placebo inhalation powder will be given as an initial single dose inhalation on 00d.During the multiple dose phase placebo will be given twice/three-times daily with a concluding single dose on day 11d.
name: Placebo
type: Drug
Study arms:
design_group_title: Arm 1
design_group_type: Experimental
design_group_title: Arm 2
design_group_type: Experimental
design_group_title: Arm 3
design_group_type: Experimental
design_group_title: Arm 4
design_group_type: Placebo Comparator
Sponsor: Bayer AG
Collaborators: Novartis AG
Drug name mappings:
name: 环丙沙星
lang: CN
name: Ciprofloxacin
lang: EN
name: シプロフロキサシン
lang: JP
Clinical trial NCT05806814: Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer
Official title: Pilot Trial to Investigate Immune Response to an Extended Course of Sipuleucel-T Immunotherapy in Patients With Metastatic Castration-resistant Prostate Cancer (OU-SCC-EXCITE)
Conditions: Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Summary: Proposed immunotherapy with an extended course of Sipuleucel-T treatment may induce a more robust immune response and improve the anti-cancer efficacy of Sipuleucel-T in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC).
Interventions:
description: Three doses of Sipuleucel-T, each containing a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, given at week 0, 2, and 12-14.
name: Sipuleucel-T
other_name: PROVENGE
type: Biological
Study arms:
design_group_title: Extended course of Sipuleucel-T treatment
design_group_type: Experimental
Sponsor: University of Oklahoma
Collaborators: Dendreon Corp.
Drug name mappings:
name: Sipuleucel-T (Dendreon Corporation)
lang: EN
Clinical trial NCT05021887: A Bioequivalence Study Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers Under Fasting Conditions
Official title: A Randomized, Single-dose, Open Label, Two-treatment, Two-sequence, Two-period, Crossover Study Under Fasting Conditions to Examine the Bioequivalence Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers
Conditions: Asthma
Bioequivalence
Summary: Bioequivalence study between two inhaler products of ffluticasone propionate inhalation powder
Interventions:
description: 2 inhalations of Test and Reference product in each study period
name: Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals
other_name: Test
type: Drug
description: 2 inhalations of Test and Reference product in each study period
name: FLOVENT DISKUS
other_name: Reference
type: Drug
Study arms:
design_group_description: Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals
design_group_title: Test Product
design_group_type: Experimental
design_group_description: FLOVENT DISKUS® 100 mcg/Blister Oral Inhalation Powder /GSK
design_group_title: Reference Product
design_group_type: Active Comparator
Sponsor: Respirent Pharmaceuticals Co. Ltd.
Collaborators: Becro Ltd.
Drug name mappings:
name: 丙酸氟替卡松
lang: CN
name: Fluticasone Propionate
lang: EN
name: フルチカゾンプロピオン酸エステル
lang: JP
Clinical trial NCT02120807: Certolizumab in Combination With Chemotherapy for Patients With Stage IV Lung Adenocarcinomas
Official title: A Phase I Trial of Certolizumab in Combination With Chemotherapy for Patients With Stage IV Lung Adenocarcinomas
Conditions: Stage IV Lung Adenocarcinoma
Summary: The purpose of this study is to test the safety of certolizumab when it is given with the chemotherapy drugs cisplatin and pemetrexed. Cisplatin and pemetrexed are two chemotherapy drugs used in the treatment of lung cancer. The investigators want to find out what effects, good and/or bad, certolizumab has on the patient and lung cancer.
Interventions:
name: Certolizumab
type: Drug
name: cisplatin
type: Drug
name: pemetrexed
type: Drug
Study arms:
design_group_description: Patients will receive certolizumab with 6 cycles of cisplatin & pemetrexed. Cycle of chemo will be 3 weeks. Certolizumab will be adm in the following fashion: first dose administered at the time of treatment initiation, second dose will be given after 2 weeks of treatment, third dose after four weeks of treatment, & subsequent doses given every 4 weeks thereafter. Patients will be monitored for progression of disease using RECIST 1.1 with scans to be performed every 6 weeks. Posttreatment biopsies will be performed at the time of treatment discontinuation. Two dose levels of certolizumab will be tested, 200mg & 400mg. A non-therapeutic cohort of 10 patients with adenocarcinomas who will be undergoing standard of care treatment with platinum based chemotherapy + pemetrexed +/- bevacizumab will be consented for blood draws before each cycle of treatment. This blood will be analyzed for cytokines and will serve as a reference for the experimental arm.
design_group_title: certolizumab, cisplatin and pemetrexed
design_group_type: Experimental
Sponsor: Memorial Sloan Kettering Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 培美曲塞二钾
lang: CN
name: Pemetrexed Dipotassium
lang: EN
name: 顺铂
lang: CN
name: Cisplatin
lang: EN
name: シスプラチン
lang: JP
name: 培塞利珠单抗
lang: CN
name: Certolizumab Pegol
lang: EN
name: セルトリズマブ ペゴル（遺伝子組換え）
lang: JP
Clinical trial NCT02460484: Safety of Autologous Human Umbilical Cord Blood Treatment for Perinatal Arterial Ischemic Stroke
Official title: Safety of Autologous Human Umbilical Cord Blood Treatment for Perinatal
Conditions: Perinatal Arterial Ischemic Stroke
Summary: Autologous human umbilical cord blood (hUCB) stored at Cord Blood Registry will be given to children who have suffered from a Perinatal Arterial Ischemic Stroke. The aim is to determine if hUCB infusion is safe, if late functional outcome is improved, if hUCB treatment improves physiologic response in the child's SSEP & EEG, and the effect of hUCB infusion in altering anatomic findings on MRI.
Interventions:
description: Intravenous infusion
name: Autologous Cord Blood Infusion
type: Biological
Study arms:
design_group_description: Autologous cord blood infusion
design_group_title: Cord Blood Infusion
design_group_type: Experimental
Sponsor: AdventHealth Waterman
Collaborators: CBR Systems, Inc.
Drug name mappings:
name: Autologous Human Umbilical Cord Blood(AdventHealth)
lang: EN
Clinical trial NCT02459613: Assessment of Radiolabeled rhAnnexin V-128 in Infective Endocarditis
Official title: Evaluation de la rhAnnexine V-128 radiomarquée Dans le Diagnostic de l'Endocardite Infectieuse, du Thrombus Atrial et de Leurs Complications Emboliques associées
Conditions: Endocarditis
Thrombosis
Summary: Intraluminal thrombi adherent to cardiac valves or atria share a common pathophysiology involving the aggregation of activated platelets with phosphatidylserine (PS) expression on the outer layer of the thrombus. They also share common complications, i.e. damages to the underlying myocardium and embolic risk related to thrombus fragmentation. The diagnostic work-up, currently relying on morphologic imaging alone (mainly echography), lacks sensitivity and does not allow to differentiate between active (renewal and growth activity) and quiescent (scarred) thrombus. It is therefore highly desirable to develop a new approach able to non-invasively provide insight on the biological activity of thrombi and to detect embolic events in a single exam.
Annexin V is a 36 kDa endogenous glycoprotein which binds PS with nanomolar affinity. Radiolabeled Annexin V has been shown to provide molecular imaging of PS expressed by apoptotic cells or activated platelets. The ability of the imaging agent to bind mural thrombus has been established in vivo in a murine model of abdominal aortic aneurysm and ex vivo in human. It has been also shown that radiolabeled Annexin V allowed in vivo detection of vegetations and secondary pulmonary emboli with high sensitivity in various animal models of infective endocarditis.
A radiolabeling kit of annexin V complying with GMP requirements has been developed (rhAnnexine V-128, Advanced Accelerator Applications - Atreus) and is currently available. AnniE is a single centre, proof of concept, interventional, open, non-randomized study aiming at evaluating the sensitivity of 99mTc-Annexin V-128 in the detection thrombus in comparison with reference imaging in patients presenting with either: 1/ infective endocarditis or 2/ atrial thrombus. The safety of the 99mTc-Annexin V-128 will be assessed in a first phase (10 first patients enrolled). Data in relation with safety of the imaging agent will be reviewed by an independent Data and Safety Monitoring Board (DSMB); in case of positive answer, the study will continue with a second phase. The data gathered in all patients (n=120) will be used to determine outcome measures.
Interventions:
name: 99mTc-Annexin V-128 SPECT
type: Drug
Study arms:
design_group_description: 99mTc Annexin V-128 SPECT
design_group_title: Imaging
design_group_type: Experimental
Sponsor: Institut National de la Santé et de la Recherche Médicale
Collaborators: Advanced Accelerator Applications SA
Drug name mappings:
name: Tc-99m-annexin V-128
lang: EN
Clinical trial NCT03183206: Safety and Efficiency of γδ T Cell Against Breast Cancer
Official title: γδ T Cell Immunotherapy for Treatment of Breast Cancer
Conditions: Breast Cancer
Summary: In this study, effects of γδT cells on human Breast Cancer in combination with tumor reducing surgery, for example, cryosurgery going to be investigated.
Interventions:
description: surgery will be used in local tumor
name: Cryosurgery , IRE surgery ,surgery
type: Procedure
description: γδ T cells will be used against
name: γδ T cells
type: Biological
description: Combination γδ T cell and Cryosurgery, IRE surgery or surgery will be used in Breast Cancer
name: γδ T cells/ Surgery
type: Other
Study arms:
design_group_description: In this group, the patients will receive under CT Cryosurgery , IRE surgery or open surgery to control the local tumor
design_group_title: Group A
design_group_type: Experimental
design_group_description: In this group, the patients will receive multiple high-activity γδ T cell immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell)
design_group_title: Group B
design_group_type: Experimental
design_group_description: In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and Cryosurgery, IRE surgery or open surgery
design_group_title: Group C
design_group_type: Experimental
Collaborators: Jinan University
Drug name mappings:
name: γδ T Cell(Fuda Cancer Hospital)
lang: EN
Clinical trial NCT00682929: Cannabis for Spasticity in Multiple Sclerosis
Official title: Cannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled Study
Conditions: Multiple Sclerosis
Summary: The purpose of this study is to learn if the use of inhaled cannabis (marijuana) and oral cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana) is safe and effective in reducing the symptoms of spasticity and tremor in patients with secondary-progressive or primary progressive multiple sclerosis.
Interventions:
description: Participants will be instructed to smoke one cannabis cigarette, daily for 7 weeks.
name: Inhaled Cannabis
other_name: Cannabis
type: Drug
description: Participants will be instructed to take two 5 mg dronabinol tablets two hours prior to the inhaled medication, daily for 7 weeks.
name: Oral THC
other_name: dronabinol
type: Drug
description: Participants will be instructed to take two placebo tablets two hours prior to the inhaled medication, daily for 7 weeks.
name: Oral Placebo
other_name: placebo
type: Drug
description: Participants will be instructed to smoke one placebo cigarette, daily for 7 weeks.
name: Inhaled placebo
other_name: placebo
type: Drug
Study arms:
design_group_description: Inhaled cannabis is compared to oral placebo.
design_group_title: 1) Inhaled Cannabis
design_group_type: Active Comparator
design_group_description: Inhaled placebo is compared to oral THC.
design_group_title: 2) Oral THC
design_group_type: Active Comparator
design_group_description: Inhaled placebo is compared to oral placebo.
design_group_title: 3) Placebo
design_group_type: Placebo Comparator
Sponsor: University of California, Davis
Collaborators: The National Multiple Sclerosis Society
Drug name mappings:
name: 屈大麻酚
lang: CN
name: Dronabinol
lang: EN
Clinical trial NCT04262427: The CAPER Trial: A Phase Ib Clinical Trial of Cyclophosphamide And PEmbrolizumab in Metastatic Renal Cell Carcinoma
Official title: The CAPER Study: A Phase Ib Clinical Trial of Cyclophosphamide And PEmbrolizumab in Metastatic Renal Cell Carcinoma (RCC) (CAPER Trial)
Conditions: Metastatic Renal Cell Carcinoma
Summary: This is an open label investigator initiated Phase Ib study of combination pembrolizumab (Keytruda), 200mg IV 3 weekly (Q3W) with 50mg oral cyclophosphamide daily (OD) in metastatic renal cell carcinoma patients. 21 patients will be recruited within the United Kingdom (UK) will to examine the efficacy of the combination for up to 35 administrations (2 years). This study will be conducted in compliance with Good Clinical Practice (GCP) and all relevant regulations.
Interventions:
description: cytotoxic chemotherapy
name: Cyclophosphamide 50mg
other_name: cyclophosphamide monohydrate
type: Drug
description: potent humanized immunoglobulin (Ig) G4 monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD-1) receptor
name: Pembrolizumab 25 mg/1 ML Intravenous Solution [KEYTRUDA]
other_name: Keytruda, MK-3475
type: Drug
Study arms:
design_group_description: Cyclophosphamide 50mg PO OD for 3 weeks as monotherapy followed by cyclophosphamide 50mg PO OD with pembrolizumab 200mg IV every 3 weeks
design_group_title: Single Group Assignment
design_group_type: Experimental
Sponsor: The Christie Pathology Partnership LLP
Collaborators: The University of Manchester
Merck Sharp & Dohme Corp.
The University of Liverpool
Drug name mappings:
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: 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 NCT05326035: A Study of WJ05129 in Advanced Malignant Solid Tumors
Official title: A Phase I/II Clinical Study of WJ05129 Tablets in Patients With Locally Advanced or Metastatic Malignant Solid Tumors
Conditions: Locally Advanced or Metastatic Malignant Solid Tumors
Summary: This study was an open, multicenter Phase I/II clinical study of WJ05129 in patients with locally advanced or metastatic malignant solid tumors in China, which was divided into three stages: Single-dose escalation,Combined dose extension and efficacy extension. The study included screening, treatment and follow-up periods. The starting dose of this dose-escalation study was set at 2.5 mg/day. Five dose levels were preset.A more flexible "BOIN" dose escalation method was adopted. The maximum tolerated dose observation period was the first treatment cycle of single administration and multiple consecutive administrations (a total of 2 days) + 21 days = 23 days; In this stage, the two dosage levels of the injectable WJ05129 (RP2D dosage and the lower dose before RP2D) will be selected as the escalating doses for the combined use of WJ05129. The "BOIN" design will be adopted for dose escalation. Paclitaxel 80mg/m2 will be intravenously infused on days 1, 8, and 15. A 28-day cycle will be used, with the first cycle being the DLT observation period.Efficacy expansion phase: It is preliminarily planned to expand three cohorts of Rb negative TNBC and SCLC andOther solid tumors（Such as gastric and esophageal adenomas, gynecological tumors, etc.）, and recruit about 20-40 people in each cohort.
Interventions:
description: Twice daily (except for single dose), 12 hours apart, fixed time is recommended
name: WJ05129
type: Drug
description: 80mg/m2 (The maximum dose is 80mg/m2 , and the dose can be adjusted according to the actual situation), The medication is administered on days 1, 8, and 15, and a 28-day period constitutes one cycle.
name: Paclitaxel injection
type: Drug
Study arms:
design_group_title: WJ05129 tablets
design_group_type: Experimental
design_group_title: WJ05129 combined with paclitaxel
design_group_type: Experimental
Sponsor: Suzhou Junjing BioSciences Co., Ltd.
Collaborators: Parsley Health, Inc.
Drug name mappings:
name: WJ-05129
lang: EN
name: 紫杉醇
lang: CN
name: Paclitaxel
lang: EN
name: パクリタキセル
lang: JP
Clinical trial NCT03883581: Impact of Nuedexta on Bulbar Physiology and Function in ALS
Official title: Impact of Nuedexta on Bulbar Physiology and Function in ALS
Conditions: Amyotrophic Lateral Sclerosis
Summary: Nuedexta is FDA approved for the treatment of pseudobulbar affect in ALS patients and anecdotal reports of improvements in speech, salivation or swallowing have been reported. However, no prospective study has been conducted to comprehensively examine and determine the physiologic impact of Nuedexta on both speech and swallowing physiology in a large group of ALS individuals. These data are needed in order to provide evidence-based guidance to the management of bulbar dysfunction in ALS.
Interventions:
description: All eligible and enrolled study participants will be administered the study drug, Nuedexta, as recommended by their treating neurologists.The drug will be administered per the efficacy and safety protocol, with no changes in administration method or recommended dose for individuals with ALS. Prior to commencing treatment with Nuedexta, participants will undergo a comprehensive bulbar evaluation of swallowing, airway protection, speech functions, and complete validated patient-reported surveys. Following 30 days of Nuedexta treatment, participants will be e-evaluated using the same battery of assessments.
name: dextromethorphan HBr and quinidine sulfate
other_name: Nuedexta
type: Drug
Study arms:
design_group_description: Participants enrolled in this group will be prescribed dextromethorphan HBr and quinidine sulfate (Nuedexta) as recommended by their treating neurologist. 20 mg dextromethorphan HBr and 10mg quinidine sulfate will be administered orally with 1 capsule every day for the initial 7 days followed by 1 capsule every 12 hours for the remaining 23 days of the study. Participants will be evaluated 30 days apart to determine the impact of treatment.
design_group_title: ALS individuals with bulbar dysfunction
design_group_type: Experimental
Sponsor: University of Florida
Collaborators: The Amyotrophic Lateral Sclerosis Association
Holy Cross Hospital
Drug name mappings:
name: 氢溴酸右美沙芬/硫酸奎尼丁
lang: CN
name: Dextromethorphan Hydrobromide/Quinidine Sulfate
lang: EN
Clinical trial NCT03797092: Stem Cell Therapy in Non-IschEmic Non-treatable Dilated CardiomyopathiEs II: a Pilot Study
Official title: Stem Cell Therapy in Non-IschEmic Non-treatable Dilated CardiomyopathiEs II: a Pilot Study
Conditions: Non-ischemic Dilated Cardiomyopathy
Summary: The overall aim of the project is to test the feasibility and safety of allogeneic adipose-derived stromal cells (CSCC_ASC) investigational medicinal product, to improve myocardial function in patients with non-ischemic dilated cardiomyopathies (NIDCM) and heart failure.
Interventions:
description: Active group
name: Allogeneic adipose-derived stromal cells (CSCC_ASC)
other_name: Investigational medicinal product
type: Biological
description: No treatment
name: Control group
type: Other
Study arms:
design_group_description: Allogeneic adipose-derived stromal cells (CSCC_ASC)
design_group_title: Active
design_group_type: Active Comparator
design_group_description: No treatment
design_group_title: Control group
design_group_type: No Intervention
Sponsor: Rigshospitalet
Collaborators: UMC Ljubljana
Drug name mappings:
name: Adipose-derived MesenchymAl Stem Cells(Rigshospitalet)
lang: EN