PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT02758730: Study Assessing Tolerability and Safety and Exploring the Immunogenicity and Therapeutic Activity of AFFITOPE® PD01A in PD-GBA Patients
Official title: A Randomized, Placebo-controlled, Parallel Group, Patient-blind, Single-center Phase I Pilot Study Assessing Tolerability and Safety and Exploring the Immunogenicity and Therapeutic Activity of AFFITOPE® PD01A, a New Vaccine Against Alpha-synuclein, in Patients With PD-GBA
Conditions: Parkinson's Disease
Summary: This is a randomized, placebo-controlled, parallel group, patient-blind, single-center phase I clinical trial of repeated once every 4 weeks administration by subcutaneous injection of AFFITOPE® PD01A, adsorbed to aluminium oxide in 30 patients with PD-GBA over a treatment period of 8 weeks. Patients will be randomized in a 2:1 ratio to two different treatment groups: A) 75 µg AFFITOPE® PD01A, adsorbed to aluminium oxide and B) placebo (= 1 mg aluminium oxide).
Over a study duration of 52 weeks, each patient will receive 3 injections of AFFITOPE® PD01A or placebo during the participation in the clinical trial. Patients will either receive 75 µg AFFITOPE® PD01A adsorbed to 1 mg aluminium oxide or placebo (=1mg aluminium oxide). The treatment group consists of 20 PDGBA patients, the placebo group of 10 PDGBA patients. Male and female patients aged 40 to 80 years can participate in the trial.
AFF010 is part of the project MULTISYN funded by the European Commission (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602646).
Interventions:
description: s.c. injection
name: AFFITOPE® PD01A + Adjuvant
type: Biological
description: s.c. injection
name: Adjuvant without active component
type: Biological
Study arms:
design_group_description: 3 injections of 75µg AFFITOPE® PD01A/ adjuvanted, once every 4 weeks
design_group_title: AFFITOPE® PD01A + Adjuvant
design_group_type: Experimental
design_group_description: 3 injections of Placebo once every 4 weeks
design_group_title: Adjuvant without active component
design_group_type: Placebo Comparator
Sponsor: AFFiRiS AG
Collaborators: University Hospital Tübingen
Drug name mappings:
name: Affitope-PD01
lang: EN
Clinical trial NCT07122453: Safety and PK of Intrathecal CNTX-3001 for Intractable Chronic Low Back Pain
Official title: A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Single Ascending Doses of Intrathecal CNTX-3001 in Subjects With Intractable Chronic Moderate to Severe Low Back Pain
Conditions: Lower Back Pain
Summary: This clinical study is being conducted to evaluate the safety, tolerability, plasma pharmacokinetics and efficacy of an investigational drug called CNTX-3001. This Phase 1 study is the first time that CNTX-3001 will be given to people (first-in-human study). The study is being done to evaluate whether CNTX-3001, given into the intrathecal space by lumbar puncture, can be administered safely to participants who have been diagnosed with intractable chronic moderate to severe low back pain and who have not responded well to other treatments in the past.
CNTX-3001 is a novel, non-opioid small molecule
Interventions:
description: non-opioid analgesic
name: CNTX-3001
type: Drug
description: Placebo product
name: Placebo
type: Drug
Study arms:
design_group_description: Single intrathecal injection of CNTX-3001
design_group_title: CNTX-3001
design_group_type: Experimental
design_group_description: Single intrathecal injection of normal saline
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Centrexion Therapeutics Corp.
Collaborators: National Institute of Neurological Disorders & Stroke
Drug name mappings:
name: CNTX-3001
lang: EN
Clinical trial NCT04395950: Effects of ACC Inhibitor on Lipid and Lipoprotein Metabolism
Official title: A Phase 1B, Single-Blinded, Linear Two Period, Placebo-controlled Study to Evaluate the Effects of 10 mg/Day of PF-05221304, Liver Targeted Acetyl-CoA Carboxylase Inhibitor (ACCi) on Very Low Density Lipoprotein ApoB100 and TG Secretion
Conditions: NASH (Nonalcoholic Steatohepatitis)
NAFLD (Nonalcoholic Fatty Liver Disease)
Summary: The purpose of this study is to assess the effects of an investigational drug, PF-05221304 (PF'1304) on the way the liver handles fat. The planned study will identify why the fat in the blood increases at the same time this drug reduces fat in the liver. The study will have two treatment periods of 6 weeks each, separated by a 3 week rest period with no treatment. The subjects will receive the active drug in one of the 6 week treatment periods and a placebo in the other 6 week period. The investigators will know when the subjects are receiving active treatment or placebo, but the subject will not know.
Interventions:
description: PF-05221304 10 mg daily (two 5mg tablets daily in the morning for 6 weeks)
name: PF-05221304
other_name: PF1304
type: Drug
description: Placebo two tablets daily in the morning for 6 weeks
name: Placebo
other_name: Placebo tablets
type: Drug
Study arms:
design_group_description: PF-05221304 10 mg daily (two 5mg tablets daily in the morning).
design_group_title: PF-0522130
design_group_type: Active Comparator
design_group_description: Placebo (two tablets daily in the morning).
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Columbia University
Collaborators: Pfizer Inc.
Drug name mappings:
name: Clesacostat
lang: EN
Clinical trial NCT00509613: Phase 1 Study With Sorafenib and Sirolimus
Official title: Phase 1 Dose Escalation Study With Sorafenib in Combination With Sirolimus in Patients With Solid Tumor
Conditions: Advanced Solid Tumor
Refractory to Standard Therapies
Summary: The purpose of the trial is to identify the recommended dose of sorafenib and sirolimus for combination therapy in subsequent phase 2 trials.
Interventions:
name: Sorafenib
type: Drug
name: Sirolimus
type: Drug
Study arms:
Sponsor: Radboud University Medical Center
Collaborators: Bayer AG
Drug name mappings:
name: 西罗莫司
lang: CN
name: Sirolimus
lang: EN
name: シロリムス
lang: JP
name: 甲苯磺酸索拉非尼
lang: CN
name: Sorafenib Tosylate
lang: EN
name: ソラフェニブトシル酸塩
lang: JP
Clinical trial NCT02502006: Variability in Response to Non-steroidal Anti-inflammatory Drugs
Official title: A Double-blind, Placebo-controlled Investigation of Inter-individual Variability in Pharmacologic Response to Non-steroidal Anti-inflammatory Drugs
Conditions: Healthy
Summary: This research study will evaluate inter-individual variability in the response to the non-steroidal anti-inflammatory drugs (NSAIDs), celecoxib and naproxen, among healthy adults. It will also investigate what factors, like age, sex, or genetic background, cause this variability.
Interventions:
name: Celecoxib
other_name: Celebrex
type: Drug
name: Naproxen
other_name: Naprosyn
type: Drug
name: Placebo
type: Drug
Study arms:
design_group_description: During each treatment phase, subjects will receive celecoxib (200 mg by mouth twice daily), naproxen (500 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects will be instructed to take the study medications twice a day (at approximately 8 AM and 8 PM) on an empty stomach with a full glass of water.
design_group_title: High Dose
design_group_type: Experimental
design_group_description: During each treatment phase, subjects will receive celecoxib (100 mg by mouth twice daily), naproxen (250 mg by mouth twice daily), or placebo (twice daily) for 7 days. Subjects will be instructed to take the study medications twice a day (at approximately 8 AM and 8 PM) on an empty stomach with a full glass of water.
design_group_title: Low dose
design_group_type: Experimental
Sponsor: University of Pennsylvania
Collaborators: National Heart, Lung & Blood Institute
Drug name mappings:
name: 萘普生
lang: CN
name: Naproxen
lang: EN
name: ナプロキセン
lang: JP
name: 塞来昔布
lang: CN
name: Celecoxib
lang: EN
name: セレコキシブ
lang: JP
Clinical trial NCT02281344: MMV390048 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Participants
Official title: A Proof-of-concept Study to Assess the Effect of MMV390048 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Participants.
Conditions: Malaria, Falciparum
Summary: A single-centre, open-label, study using induced blood stage malaria infection to characterize the activity of MMV390048 against early Plasmodium falciparum blood stage infection.
Interventions:
description: Supplied as a powder to be prepared as a suspension for oral use
name: MMV390048 20mg
type: Drug
Study arms:
design_group_description: Cohort 1 will receive a single dose of 20mg MMV390048.
design_group_title: Cohort 1
design_group_type: Experimental
Sponsor: MMV Medicines for Malaria Venture
Collaborators: Q-Pharm Pty Ltd.
Drug name mappings:
name: MMV-390048
lang: EN
Clinical trial NCT07544589: A Phase 1 Study Evaluating DISP-10 in Participants With Advanced Gastrointestinal Cancers
Official title: A Phase 1 Study to Evaluate the Safety and Efficacy of DISP-10 in Participants With Advanced Gastrointestinal Cancers
Conditions: Colorectal Cancer
Gastric Adenocarcinoma
Esophageal Adenocarcinoma
Gastroesophageal Adenocarcinoma
Summary: This is a Phase 1, multicenter, open-label study of DISP-10, a combination therapy consisting of DV-10 (adenovirus) and idecabtagene vicleucel (ide-cel, BCMA-directed chimeric antigen receptor [CAR] T), in adult participants with advanced gastrointestinal (GI) cancers.
The study will consist of 2 parts: dose-escalation (Part 1) and dose-expansion (Part 2). Part 1 of the study will evaluate the safety and tolerability of increasing dose levels of DISP-10 to establish the recommended dose for expansion (RDE); Part 2 will evaluate the safety and efficacy of DISP-10 in participants treated at the RDE.
Interventions:
description: Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce ide-cel.<br/>During ide-cel production, participants may receive bridging therapy for disease control per Investigator discretion.<br/>DV-10 administration will be followed by lymphodepleting chemotherapy (fludarabine and cyclophosphamide) and subsequent ide-cel administration.
name: DISP-10
type: Biological
Study arms:
design_group_description: Participants will receive DV-10 in combination with ide-cel. Lymphodepleting chemotherapy (fludarabine and cyclophosphamide) will be administered a few days prior to ide-cel.
design_group_title: DISP-10
design_group_type: Experimental
Sponsor: Dispatch Biotherapeutics
Collaborators: Bristol Myers Squibb Co.
Drug name mappings:
name: DISP-10
lang: EN
Clinical trial NCT03465436: A Study of Lasmiditan on the Heart in Healthy Participants
Official title: A Randomized, Double-blind, Placebo-controlled, 4-way Crossover Study to Compare the Effects on the Cardiac De- and Repolarization Duration as Well as Other Cardiac Safety Parameters of Two Doses of Oral Lasmiditan (100 mg and 400 mg) With Those of Moxifloxacin (400 mg) and Placebo in Healthy Subjects
Conditions: Healthy
Summary: The purpose of this study was to determine how two doses of lasmiditan affected the heart in healthy participants. The study also evaluated how much lasmiditan got into the blood stream and how long it took the body to get rid of it. Information about side effects was collected. The study lasted a maximum of 46 days for each participant, not including screening.
Interventions:
description: 100 mg administered orally (PO)
name: Lasmiditan
other_name: LY573144
type: Drug
description: 400 mg administered PO
name: Lasmiditan
other_name: LY573144
type: Drug
description: Placebo administered for lasmiditan or moxifloxacin
name: Placebo
type: Drug
description: 400 mg moxifloxacin administered PO
name: Moxifloxacin
type: Drug
Study arms:
design_group_description: A single, PO dose of 100 mg lasmiditan administered on Day 1 in one of four treatment periods.
design_group_title: 100 milligrams (mg) Lasmiditan
design_group_type: Experimental
design_group_description: A single, PO dose of 400 mg lasmiditan administered on Day 1 in one of four treatment periods.
design_group_title: 400 mg Lasmiditan
design_group_type: Experimental
design_group_description: Placebo for lasmiditan and placebo for moxifloxacin administered on Day 1 in one of four treatment periods.
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: A single, PO dose of moxifloxacin administered on Day 1 in one of four treatment periods.
design_group_title: Moxifloxacin
design_group_type: Active Comparator
Sponsor: Eli Lilly & Co.
Collaborators: CoLucid Pharmaceuticals, Inc.
Drug name mappings:
name: 拉米地坦
lang: CN
name: Lasmiditan Succinate
lang: EN
name: ラスミジタンコハク酸塩
lang: JP
Clinical trial NCT01274182: GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy
Official title: A Randomized, Double-blind, Controlled Study to Evaluate PK, PD, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis Refractory or Intolerant to Standard DMARDs and up to Three Anti-TNF Therapies.
Conditions: Rheumatoid Arthritis
Summary: The purpose of this study is to determine the PK/PD, efficacy and safety of GP2013 in patients with severe rheumatoid arthritis.
Interventions:
description: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
name: GP2013
type: Biological
description: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
name: MabThera
other_name: EU-Rituximab
type: Biological
description: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
name: Rituxan
other_name: US-Rituximab
type: Biological
Study arms:
design_group_title: GP2013
design_group_type: Experimental
design_group_title: MabThera
design_group_type: Active Comparator
design_group_title: Rituxan
design_group_type: Active Comparator
Sponsor: Sandoz Group AG
Collaborators: Novartis Pharmaceuticals Corp.
Drug name mappings:
name: 利妥昔单抗生物类似药(Sandoz International GmbH)
lang: CN
name: Rituximab(Sandoz International GmbH)
lang: EN
name: リツキシマブ（遺伝子組換え）
lang: JP
Clinical trial NCT01755975: Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma
Official title: A Phase Ib/IIa Study of Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma
Conditions: Multiple Myeloma
Non-Hodgkin's Lymphoma
Summary: The treatments used to treat lymphoma and multiple myeloma sometimes do not always work well or they may only work for a short period of time. This is why new treatments are being tested.
This study will test a new combination of two drugs that are already approved by the Food and Drug Administration for treatment of certain kinds of blood cancers. These drugs are romidepsin and lenalidomide. Both these drugs by themselves have been used to treat lymphoma or multiple myeloma. However, while these drugs are routinely used alone, this is the first time they will be tested together. The mechanism of action of both drugs is not well understood but both have been shown to to be effective by themselves in lymphoma and multiple myeloma.
Interventions:
description: Romidepsin will be administered intravenously on days 1, 8, and 15 of a 28-day cycle.
name: Romidepsin
type: Drug
description: Lenalidomide will be taken orally daily for 21 days of a 28-day cycle.
name: Lenalidomide
type: Drug
Study arms:
design_group_description: This will be a multicentered, open label, phase Ib/IIa trial of romidepsin and lenalidomide in patients with relapsed or refractory lymphomas or multiple myeloma. Lenalidomide will be provided in accordance with the Celgene Corporation's Revlimid REMS® program. Per standard Revlimid REMS® program requirements, all physicians who prescribe lenalidomide for research subjects enrolled into this trial, and all research subjects enrolled into this trial, must be registered in, and must comply with, all requirements of the Revlimid REMS® program. Only enough lenalidomide for one cycle of therapy will be supplied to the patient each cycle.
design_group_title: Romidepsin and Lenalidomide
design_group_type: Experimental
Sponsor: Memorial Sloan Kettering Cancer Center
Collaborators: Weill Medical College of Cornell University
University of Nebraska
Celgene Corp.
Biologics, Inc.
St. Francis Hospital & Medical Center
Drug name mappings:
name: 来那度胺
lang: CN
name: Lenalidomide
lang: EN
name: レナリドミド水和物
lang: JP
name: 罗米地辛
lang: CN
name: Romidepsin
lang: EN
name: ロミデプシン
lang: JP
Clinical trial NCT05672095: Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer
Official title: Phase I/II Trial of Niraparib/Selenium Combination Treatment in Patients With BRCA1/2-Wild Type Recurrent Platinum-Resistant Ovarian Cancer
Conditions: Platinum-Resistant Fallopian Tube Carcinoma
Platinum-Resistant Ovarian Carcinoma
Platinum-Resistant Primary Peritoneal Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Summary: This phase I/II trial tests the safety, side effects and best dose of a combination therapy (niraparib and selenium) in treating patients with BRCA negative ovarian cancer that has come back (recurrent) and does not respond to platinum based therapy (platinum resistant). Selenium is a form of the trace element with potential antineoplastic activity which may help block the formation of growths that may become cancer. Niraparib is in a class of medications called poly (ADP-ribose) polymerase inhibitors. It works by killing cancer cells and helps maintain the response of certain types of ovarian, fallopian tube and peritoneal cancers. Giving selenium and niraparib may kill more cells in patients with ovarian cancer.
Interventions:
description: Undergo needle or core biopsy
name: Biopsy
other_name: BIOPSY_TYPE
Bx
type: Procedure
description: Undergo blood sample collection
name: Biospecimen Collection
other_name: Biological Sample Collection
Biospecimen Collected
Specimen Collection
type: Procedure
description: Given PO
name: Niraparib
other_name: MK-4827
MK4827
type: Drug
description: Ancillary studies
name: Questionnaire Administration
type: Other
description: Given IV
name: Selenium
other_name: Se
type: Dietary Supplement
Study arms:
design_group_description: Patients receive selenium IV and niraparib PO on study. Patients also undergo CT, MRI, biopsy, and collection of blood samples throughout the trial.
design_group_title: Treatment (selenium, niraparib)
design_group_type: Experimental
Sponsor: City of Hope National Medical Center
Collaborators: National Cancer Institute
Drug name mappings:
name: Selenium
lang: EN
name: 甲苯磺酸尼拉帕利
lang: CN
name: Niraparib Tosylate
lang: EN
name: ニラパリブトシル酸塩水和物
lang: JP
Clinical trial NCT04123470: A Phase I/II Trial Investigating LOAd703 in Combination With Atezolizumab in Malignant Melanoma
Official title: A Phase I/II Trial Investigating LOAd703 in Combination With Atezolizumab in Malignant Melanoma
Conditions: Malignant Melanoma
Summary: This study aims to evaluate safety and effect of combining an oncolytic adenovirus (delolimogene mupadenorepvec; LOAd703) with atezolizumab in patients with melanoma. LOAd703 will be administered intratumorally for up to 12 injections while atezolizumab will be administered intravenously for the duration of the active study visits (up to 57 weeks). The patients are then monitored for survival for maximum study participation of 48 months. The treatments will be given every 3 weeks. The patients will then be monitored for toxicity, PK, ADA, immune responses, virus shedding, tumor response by RECIST 1.1 and survival.
Interventions:
description: LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL
name: delolimogene mupadenorepvec
other_name: LOAd703
type: Genetic
description: Atezolizumab is an anti-PD-L1 antibody
name: atezolizumab
type: Biological
Study arms:
design_group_description: Delolimogene mupadenorepvec plus atezolizumab
design_group_title: Treatment
design_group_type: Experimental
Sponsor: Lokon Pharma AB
Collaborators: Precision Oncology LLC
Drug name mappings:
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: Delolimogene mupadenorepvec
lang: EN
Clinical trial NCT03423342: Nicotinamide Riboside in Systolic Heart Failure
Official title: Safety and Tolerability of the Nutritional Supplement, Nicotinamide Riboside, in Systolic Heart Failure
Conditions: Heart Failure, Systolic
Summary: Mitochondrial dysfunction has been implicated in heart failure (HF), and is associated with an imbalance in intracellular ratio of reduced nicotinamide-adenine dinucleotide (NADH) to oxidized nicotinamide-adenine dinucleotide (NAD), or the NADH/NAD ratio. In mouse models of HF, we have found that normalization of the NADH/NAD, through supplementation with NAD+ precursors, is associated with improvement in cardiac function. This Study will randomize participants with systolic HF (ejection fraction ≤40%) to treatment with the NAD precursor, nicotinamide riboside (NR) or matching placebo, uptitrated to a final oral dose of 1000mg twice daily, to determine the safety and tolerability of NR in participants with systolic HF.
Interventions:
description: nicotinamide riboside capsule
name: nicotinamide riboside
other_name: Niagen
type: Dietary Supplement
description: matching placebo capsule
name: Placebo
type: Drug
Study arms:
design_group_description: Nicotinamide riboside will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
design_group_title: Nicotinamide Riboside
design_group_type: Experimental
design_group_description: Matching placebo will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University of Washington
Collaborators: National Heart, Lung & Blood Institute
Drug name mappings:
name: 烟酰胺核糖
lang: CN
name: Nicotinamide riboside
lang: EN