PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT03417284: Melphalan Hydrochloride in Treating Participants With Newly-Diagnosed Multiple Myeloma Undergoing Donor Stem Cell Transplantation
Official title: Prospective Phase I/II Trial to Jointly Optimize the Administration Schedule(s) and Dose(s) of Melphalan for Injection (Evomela) as a Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
Conditions: Plasma Cell Myeloma
Summary: This phase I/II trial studies the side effects and best dose of melphalan hydrochloride in treating participants with newly-diagnosed multiple myeloma who are undergoing a donor stem cell transplantation. Giving chemotherapy before a donor stem cell transplantation helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the participant, they may help the participant's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving melphalan hydrochloride before a donor stem cell transplantation may work better than standard chemotherapy in helping to prevent multiple myeloma from coming back.
Interventions:
description: Undergo HSCT
name: Autologous Hematopoietic Stem Cell Transplantation
other_name: AHSCT
Autologous Hematopoietic Cell Transplantation
Autologous Stem Cell Transplantation
Stem Cell Transplantation, Autologous
type: Procedure
description: Given SC
name: Filgrastim-sndz
other_name: Filgrastim Biosimilar Filgrastim-sndz
Zarxio
type: Biological
description: Given IV
name: Melphalan Hydrochloride
other_name: Alkeran
Alkerana
Evomela
type: Drug
Study arms:
design_group_description: PREPARATIVE REGIMEN: Participants receive melphalan hydrochloride IV over 30-60 minutes on day -2.<br/>TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.<br/>POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10^9/L.
design_group_title: Group 1 (melphalan hydrochloride, HSCT, filgrastim)
design_group_type: Experimental
design_group_description: PREPARATIVE REGIMEN: Participants receive melphalan hydrochloride IV over 8-9 hours on day -2.<br/>TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.<br/>POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10^9/L.
design_group_title: Group 2 (melphalan hydrochloride, HSCT, filgrastim)
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 非格司亭(Sandoz International GmbH)
lang: CN
name: Filgrastim-SNDZ(Sandoz International Gmbh)
lang: EN
name: 盐酸美法仑
lang: CN
name: Melphalan hydrochloride
lang: EN
Clinical trial NCT05491135: Hepatocyte Microbeads for Acute Liver Failure
Official title: Hepatocytes Co-Encapsulated With Mesenchymal Stromal Cells in Alginate Microbeads for the Treatment of Acute Liver Failure in Paediatric Patients (HELP)
Conditions: Acute Liver Failure
Summary: Acute Liver Failure in children is associated with high mortality without liver transplantation. In addition, donor organ shortage makes it difficult to provide this treatment to every potential patient. Liver transplantation is life-saving but it carries the risk of major surgery and complications from lifelong anti-rejection drugs to suppress the immune system. If bridged across the immediate crisis following acute liver failure, the immense regenerative potential of the liver means that the patient's own liver may 're-grow'. This period is very time sensitive. Unfortunately, if the vital synthetic and detoxification function of the liver is not provided, the patient will often die before the liver can re-grow.
Transplantation of liver cells (hepatocytes) can provide this 'bridge' with considerable advantages over whole organ transplantation. Firstly, hepatocytes are derived from donor livers which are otherwise unsuitable for transplantation. Secondly, unlike whole organs, they can be frozen and stored, thus act as an 'off the shelf' treatment. Thirdly, the technique of hepatocyte transplantation within microbeads coated with alginate (a gel originating from seaweed) and infused into the abdominal cavity is much less invasive than liver transplantation. Finally, the alginate protects the cells against the body's immune system, avoiding the need for immunosuppressive drugs and the associated major risks. Furthermore, preclinical work in King's College Hospital has shown that the addition of support cells called mesenchymal stromal cells (MSCs), can significantly improve the ability of hepatocytes to survive and function within the alginate microbead.
The HELP trial is a Phase 1/2 safety and tolerability study of infusion of HMB002 (an optimal combination of hepatocytes and mesenchymal stromal cells put together in peptide-alginate microbeads) into paediatric patients with acute liver failure. This novel cellular therapy may act as a bridge treatment to liver transplant or lead to regeneration of the native liver.
Interventions:
description: The solution containing microbeads will be infused manually into the peritoneal cavity under ultrasound guidance, with usually a 50ml syringe, as a single infusion or several infusions, to achieve in excess of 25 million hepatocytes per kilogram of the body weight.
name: HMB002
type: Biological
Study arms:
design_group_description: All patients will receive HMB002 infusion into the peritoneal cavity.
design_group_title: HMB002
design_group_type: Experimental
Sponsor: King's College Hospital NHS Foundation Trust
Collaborators: The Medical Research Council
Drug name mappings:
name: HMB002
lang: EN
Clinical trial NCT01380535: Extracorporeal Photopheresis (ECP) With Methoxsalen for Chronic Graft Versus Host Disease (cGVHD)
Official title: A Randomized Controlled Study of Extracorporeal Photopheresis (ECP) Therapy With UVADEX for the Treatment of Patients With Moderate to Severe Chronic Graft-versus-Host Disease (cGvHD)
Conditions: Chronic Graft Versus Host Disease
Summary: Chronic graft-versus-host disease (cGVHD) is a long-lasting complication that can occur after transplants. The transplanted cells seem to fight with the patient's own cells.
Extracorporeal photopheresis (ECP) is a fairly new procedure for cGVHD. The participant gets a port to hook up to a machine. The machine removes the white blood cells, mixes them with a light-sensitive drug, shines light on it, and puts all the blood back in.
This study will find out if patients respond better if they get ECP with methoxsalen, in addition to the pills normally used to treat cGVHD.
Interventions:
description: Methoxsalen delivered by ECP
name: ECP Methoxsalen
other_name: Extracorporeal photopheresis (ECP)
Uvadex
type: Drug
description: Tapered prednisone with cyclosporine or tacrolimus via oral administration, consistent with local institutional practice (corticosteroids and cyclosporine A/tacrolimus)
name: Standard of Care
other_name: Reference therapy
type: Drug
Study arms:
design_group_description: Participants receive methoxsalen administered via ECP in addition to standard of care
design_group_title: ECP Methoxsalen + Standard of Care
design_group_type: Experimental
design_group_description: Participants receive standard of care only
design_group_title: Standard of Care
design_group_type: Active Comparator
Sponsor: Keenova Therapeutics Plc
Collaborators: PAREXEL International Corp.
Drug name mappings:
name: 甲氧沙林
lang: CN
name: Methoxsalen
lang: EN
name: メトキサレン
lang: JP
Clinical trial NCT01889147: Microdose and First-In-Human (FIH) Study of Recombinant Human Placental Alkaline Phosphatase (hRESCAP)
Official title: A Single Dose Study to Assess the Peak Plasma Concentration of a Microdose of Recombinant Human Placental Alkaline Phosphatase (hRESCAP, Part 1) Followed by a Single Ascending Dose, FIH Study to Assess Safety and Tolerability of hRESCAP (Part 2).
Conditions: Healthy
Summary: In the present study human recombinant placental alkaline phosphatase (hRESCAP) will be investigated. Alkaline Phosphatase is naturally present in the body and reported to use lipopolysaccharde (LPS, bacterial endotoxins) and extracellular nucleotides leaking from damaged and ischemic cells as physiological substrates. The LPS-substrate prevalence makes alkaline phosphatase an interesting novel therapeutic agent in the treatment of LPS-mediated diseases. A bovine homologue of this protein (bovine intestinal alkaline phosphatase, BIAP) has previously been investigated for treatment of acute inflammatory responses such as sepsis, and was shown to be safe in humans. hRESCAP, which will be investigated in the current study, is expected to have a longer half-life in humans than the previously investigated BIAP, due to the fact that it is more sialylated. The possibility to increase the t1/2 to days instead of minutes enables treatment of chronic diseases.
Interventions:
description: one acute bolus administration of different dosages of hRESCAP (microdose, part 1; and FIH: low dose, 414 µg; medium dose, 2480 µg; high dose, 5300 µg; part 2)
name: hRESCAP
other_name: recombinant human placental alkaline phosphatase
type: Biological
name: Placebo
type: Biological
Study arms:
design_group_description: Peak plasma concentration response of a dose hRESCAP will be examined and compared with the saline condition
design_group_title: 14C-hRESCAP
design_group_type: Active Comparator
design_group_description: Peak plasma concentration response of different dosages of hRESCAP will be examined and controlled with the saline condition
design_group_title: saline
design_group_type: Placebo Comparator
design_group_description: Peak plasma concentration of a very low dose of hRESCAP as a first test in humans (first starting dose, before the other arms).
design_group_title: Microdose
design_group_type: Active Comparator
Sponsor: Nederlandse Organisatie voor Toegepast-Natuurwetenschappelijk
Collaborators: Alloksys Life Sciences BV
Drug name mappings:
name: Recombinant human alkaline phosphatase(Alloksys Life Sciences BV)
lang: EN
Clinical trial NCT03255941: Clinical Study of Depo Provera Comparing Lay Health Workers and Clinically-trained Health Workers
Official title: 'A Randomized Controlled Trial of Safety and Effectiveness of Depo Provera Intramuscular and Subcutaneous Administration Comparing Lay Lady Health Workers With Clinically-trained Family Welfare Workers in Pakistan
Conditions: Contraception
Summary: This is a randomized controlled trial comparing lay Lady Health Workers (Lay Health Workers) with Family Welfare Workers (Clinically- trained Health Workers) on quantitative measures of safety and effectiveness of Depo Provera and Sayana Press provision in a clinic setting. This comparative trial will test the non-inferiority hypothesis that Lady Health Workers are just as competent as clinically-trained Family Welfare Workers in screening and counseling first-time injectable users. These first time users will also be randomly assigned to receive intramuscular or subcutaneous injections of DMPA.
Interventions:
description: The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.
name: DMPA
type: Drug
description: The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press
name: Sayana Press
type: Drug
Study arms:
design_group_description: Urban Clinic Provider providing DMPA or Sayana Press
design_group_title: Clinic Provider - Urban
design_group_type: Active Comparator
design_group_description: Urban Lay Provider providing DMPA or Sayana Press
design_group_title: Lay Provider - Urban
design_group_type: Active Comparator
design_group_description: Rural Clinic Provider providing DMPA or Sayana Press
design_group_title: Clinic Provider- Rural
design_group_type: Active Comparator
design_group_description: Rural Lay Provider providing DMPA or Sayana Press
design_group_title: Lay Provider- Rural
design_group_type: Active Comparator
Sponsor: FHI 360, Inc.
Collaborators: Aga Khan University
Province of Sindh
Jhpiego Corp.
Drug name mappings:
name: 醋酸甲羟孕酮
lang: CN
name: Medroxyprogesterone Acetate
lang: EN
name: メドロキシプロゲステロン酢酸エステル
lang: JP
Clinical trial NCT02929797: Immunotherapy of CD8+NKG2D+ AKT Cell With Chemotherapy to Pancreatic Cancer
Official title: A Randomized, Double Blinding, Placebo-Controlled Clinical Trials of CD8+NKG2D+ AKT Cell Immunotherapy to the Pancreatic Cancer Patients Treated With Adjuvant Chemotherapy
Conditions: Pancreatic Ductal Adenocarcinoma
Summary: A Prospective Study on the Efficacy and Safety of CD8+NKG2D+ AKT cell immunotherapy to the pancreatic cancer patients treated with adjuvant chemotherapy.
Interventions:
description: AKT: CD8+NKG2D+ AKT cell
name: CD8+NKG2D+ AKT Cell
other_name: AKT
type: Biological
description: gemcitabine
name: Gemcitabine
other_name: GEM
type: Drug
Study arms:
design_group_description: gemcitabine dose 1000mg/M^2, d1,8,15，q4w ×6 AKT 5*10^8/M^2, d16,q4w ×6 Drug: gemcitabine Biological: AKT, CD8+NKG2D+ AKT Cell
design_group_title: AKT + gemcitabine
design_group_type: Experimental
design_group_description: gemcitabine hydrochloride dose 1000mg/M2 d1,8,15，q4w ×6 Drug: gemcitabine
design_group_title: gemcitabine
design_group_type: Active Comparator
Sponsor: Shanghai First People's Hospital
Collaborators: Shanghai Saiao Biotechnology Co. Ltd.
Drug name mappings:
name: CD8+NKG2D+ AKT cell(Shanghai iCELL Biotechnology)
lang: EN
name: 盐酸吉西他滨
lang: CN
name: Gemcitabine Hydrochloride
lang: EN
name: ゲムシタビン塩酸塩
lang: JP
Clinical trial NCT05665465: Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking
Official title: Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking
Conditions: Adverse Childhood Experiences
Nicotine Dependence, Cigarettes
Summary: The purpose of this study is to evaluate how certain childhood experiences influences brain function and responses to nicotine exposure in a group of nonsmoking young adults. The investigators assess responses to nicotine exposure by giving participants a small amount of nicotine or placebo, and then asking them to answer questionnaires. The investigational drugs used in this study are a nicotine nasal spray (i.e., Nicotrol) and/or a nasal spray placebo (made of common kitchen ingredients, including a very tiny amount of pepper extract also called capsaicin). The investigators assess brain function through function magnetic resonance imaging (fMRI), which is a noninvasive procedure that uses a magnetic field to take pictures of your brain while you are performing certain tasks. This study will help us to learn more about why some childhood experiences (adverse childhood experiences, or ACEs) contribute to increased risk for smoking and other substance use.
Interventions:
description: Participants will be administered nicotine nasal spray and provide subjective reactions
name: Nicotine nasal spray 0.5 mg
other_name: Nicotrol
type: Drug
description: Participants will be administered placebo nasal spray and provide subjective reactions
name: Placebo
type: Drug
Study arms:
design_group_description: Participants will be administered 2 nasal sprays with a combined nicotine content of 0mg nicotine, 0.1mL
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: Participants will be administered 2 nasal sprays with a combined nicotine content of 0.5 mg nicotine, 0.1mL
design_group_title: 0.5mg nicotine
design_group_type: Experimental
design_group_description: Participants will be administered 2 nasal sprays with a combined nicotine content of 1.0 mg nicotine, 0.1mL
design_group_title: 1mg nicotine
design_group_type: Experimental
Sponsor: Duke University
Collaborators: National Institute on Drug Abuse
Drug name mappings:
name: 尼古丁
lang: CN
name: Nicotine
lang: EN
Clinical trial NCT06407947: Study of CT071 Injection in High Risk Newly Diagnosed Multiple Myeloma
Official title: Exploratory Clinical Trial of the Safety and Efficacy of CT071 Injection in Patients With High Risk Newly Diagnosed Multiple Myeloma
Conditions: Multiple Myeloma
Summary: This trial is a single-arm, single-center, open-label clinical trial to evaluate the safety, efficacy, and metabolism kinetics of CT071 in patients with high-risk newly diagnosed multiple myeloma.
Interventions:
description: chimeric antigen receptor T cells
name: Chimeric antigen receptor modified T cells Infusion
other_name: Single Group Assignment
type: Drug
Study arms:
design_group_description: Chimeric antigen receptor modified T cells chimeric antigen receptor T cells
design_group_title: Chimeric antigen receptor modified T cells Infusion
design_group_type: Experimental
Sponsor: Shanghai Changzheng Hospital
Collaborators: CARsgen Therapeutics Co. Ltd.
Drug name mappings:
name: CT-071
lang: EN
Clinical trial NCT06464367: Mechanistic Studies of Psilocybin in Headache Disorders
Official title: Mechanistic Studies of Psilocybin in Headache Disorders
Conditions: Migraine
Summary: In previous clinical trial work, the investigators observed lasting reductions in headache burden after limited dosing of psilocybin. This purpose of this study is to examine potential sources for this observed effect. This study will measure brain resting state functional connectivity (fMRI), central synaptic density (SV2A PET), peripheral markers of inflammation, circadian rhythm (actigraphy), and sleep (sleep EEG) in both migraine and healthy control participants before and one week after the administration of psilocybin or an active control agent.
Interventions:
description: synthetic psilocybin 10 mg (oral)
name: Psilocybin
type: Drug
description: synthetic THC 2.5 mg (oral)
name: Placebo
type: Drug
Study arms:
design_group_description: Migraine participants randomized to receive 10 mg psilocybin (oral)
design_group_title: Migraine psilocybin
design_group_type: Experimental
design_group_description: Migraine participants randomized to receive 2.5 mg THC (oral)
design_group_title: Migraine placebo
design_group_type: Placebo Comparator
design_group_description: Healthy control participants randomized to receive 10 mg psilocybin (oral)
design_group_title: Healthy control psilocybin
design_group_type: Experimental
design_group_description: Healthy control participants randomized to receive 2.5 mg THC
design_group_title: Healthy control placebo
design_group_type: Placebo Comparator
Sponsor: Yale University
Collaborators: The Wallace Foundation
Drug name mappings:
name: 裸盖菇素
lang: CN
name: Psilocybin
lang: EN
Clinical trial NCT00795457: Effects of Vaccinations With HLA-A2-Restricted Glioma Antigen-Peptides in Combination With Poly-ICLC for Adults With High-Risk WHO Grade II Astrocytomas and Oligo-Astrocytomas
Official title: A Bi-Institutional Pilot Study to Evaluate the Effects of Vaccinations With HLA-A2-Restricted Glioma Antigen-Peptides in Combination With Poly-ICLC for Adults With WHO Grade II Low-Grade Gliomas
Conditions: Astrocytoma
Oligo-Astrocytoma
Glioma
Summary: This is a pilot vaccine study in adults with either WHO grade II astrocytoma, oligoastrocytoma or oligodendroglioma. The purpose of this study is test the safety and efficacy of an experimental tumor vaccine made from peptides and Montanide ISA-51 in combination with the study drug Poly-ICLC.
Poly-ICLC, manufactured by Oncovir, Inc., has already been received and generally well tolerated by subjects in earlier studies and has been shown to decrease the size of brain tumors in some cases.
The immunological and safety data will be used to decide whether a larger study of clinical efficacy is warranted in each of two patient cohorts.
Interventions:
description: Participants will be treated with subcutaneous injections of GAA/TT-vaccines on Weeks 0, 3, 6, 9, 12, 15, 18 and 21. I.m. poly-ICLC will be administered (20 mg/kg i.m.) on the day of, and on day 4 after each vaccine (e.g. if the vaccine is administered on Thursday, poly-ICLC will be administered on the day of vaccine and the following Monday). Each vaccine will be administered within 2 hours before or after the i.m. poly-ICLC administration.
name: GAA/TT-peptide vaccine and poly-ICLC
type: Biological
description: Participants will be treated with subcutaneous injections of GAA/TT-vaccines on Weeks 0, 3, 6, 9, 12, 15, 18 and 21. I.m. poly-ICLC will be administered (20 mg/kg i.m.) on the day of, and on day 4 after each vaccine (e.g. if the vaccine is administered on Thursday, poly-ICLC will be administered on the day of vaccine and the following Monday). Each vaccine will be administered within 2 hours before or after the i.m. poly-ICLC administration.
name: GAA/TT-peptide vaccine and poly-ICLC
type: Biological
Study arms:
design_group_description: Patients must have undergone surgery or biopsy alone ≤16 weeks prior to study entry (no postoperative radiation or chemotherapy).
design_group_title: 1
design_group_type: Experimental
design_group_description: Patients received surgery or biopsy and radiation therapy (RT) (including fractionated external beam radiation therapy and/or stereotactic radiosurgery), which was completed ≥6 months prior to enrollment, and have a baseline MRI scan (within 4 weeks of the first vaccine) that shows stable disease or regression.
design_group_title: 2
design_group_type: Experimental
Sponsor: University of Pittsburgh
Collaborators: Oncovir, Inc.
National Cancer Institute
Drug name mappings:
name: 聚肌胞
lang: CN
name: Poly ICLC
lang: EN
Clinical trial NCT03349606: Cocaine Use Disorder and Cortical Dopamine
Official title: Imaging of Cortical Dopamine Transmission in Cocaine Dependence
Conditions: Cocaine Dependence
Summary: The goal of this study is to use [C-11]FLB 457 and amphetamine (oral, 0.5 mg/kg) to measure cortical dopamine transmission in cocaine dependent individuals and healthy controls
Interventions:
description: oral d- amphetamine 0.5 mg/kg is used to stimulate dopamine release in the brain
name: d-amphetamine
type: Drug
description: PET radiotracer
name: [C-11]FLB 457
type: Radiation
Study arms:
design_group_description: [C-11]FLB 457 PET at baseline and post d-amphetamine
design_group_title: Cocaine dependence
design_group_type: Experimental
design_group_description: [C-11]FLB 457 PET at baseline and post d-amphetamine
design_group_title: Controls
design_group_type: Experimental
Sponsor: University of Pittsburgh
Collaborators: National Institute on Drug Abuse
Drug name mappings:
name: 右旋安非他明
lang: CN
name: Dextroamphetamine
lang: EN
Clinical trial NCT05011760: [C-11]NPA PET-amphetamine in Cocaine Use Disorders
Official title: [C-11]NPA PET-amphetamine in Cocaine Use Disorders (Aim 2)
Conditions: Cocaine Use Disorder
Summary: This study uses [11C]NPA positron emission tomography (PET) and a d-amphetamine challenge to image amphetamine induced dopamine release in the striatum in subjects with cocaine use disorders (CUD). Amphetamine-induced dopamine release data from this study will be correlated with [11C]NOP-1A VT measured at baseline in the midbrain. [11C]NOP-1A PET data will be used from aim 1 (see, Study Record: Imaging CRF X NOP interactions in Cocaine Use Disorders)
Interventions:
description: Radiotracer
name: Baseline [C-11]NPA PET Scan
type: Radiation
description: Oral, 0.5 mg/Kg
name: d-amphetamine
type: Drug
description: Radiotracer
name: Post-amphetamine [C-11]NPA PET Scan
type: Radiation
Study arms:
design_group_description: [C-11]NPA PET Scan
design_group_title: PET
design_group_type: Experimental
Sponsor: University of Pittsburgh
Collaborators: National Institute on Drug Abuse
Drug name mappings:
name: 右旋安非他明
lang: CN
name: Dextroamphetamine
lang: EN