PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT02577575: Adult Oxytocin Study
Official title: The Effects of Oxytocin on Social Cognition in Patients With Schizophrenia
Conditions: Schizophrenia
Oxytocin
Social Cognition
Summary: In this study, investigators will examine the behavioral effects and neurophysiological mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset schizophrenia. Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia.
Aim 1: To quantify the effects of exogenous oxytocin on social cognition and behavior in patients with recent-onset schizophrenia.
Hypothesis A: Patients and healthy comparison subjects will show enhanced social cognition (e.g., improved interpretation of paralinguistic and emotional cues, such as those involved in emotional or sarcastic communication) after administration of oxytocin versus placebo.
Hypothesis B: Patients and healthy comparison subjects will show increased attention to others' eyes and patients will exhibit increased facial affect expressivity after administration of oxytocin versus placebo.
Aim 2: To examine the effects of exogenous oxytocin on persistent negative symptoms in schizophrenia (PNS) activity in patients with recent-onset schizophrenia.
Hypothesis A: Patients and healthy comparison subjects will demonstrate increased PNS activity during social tasks after administration of oxytocin versus placebo.
Hypothesis B (exploratory): Patients and healthy comparison subjects' improvements in social cognition and behavior will be predicted by the degree to which oxytocin increases their PNS activity.
Interventions:
description: 40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
name: Oxytocin
other_name: Syntocinon
type: Drug
description: 40 IU of the saline nasal spray will be administered once at the beginning of the visit.
name: Saline Nasal Spray
other_name: Placebo
type: Drug
Study arms:
design_group_description: 40 IU Oxytocin
design_group_title: Oxytocin
design_group_type: Experimental
design_group_description: Placebo Comparator
design_group_title: Saline Nasal Spray
design_group_type: Placebo Comparator
Sponsor: The University of California, San Francisco
Collaborators: San Francisco VA Medical Center
Drug name mappings:
name: 缩宫素
lang: CN
name: Oxytocin
lang: EN
name: オキシトシン
lang: JP
Clinical trial NCT02828033: Rilonacept for Treatment of Autoimmune Neurosensory Hearing Loss
Official title: A Pilot Trial of Rilonacept for Treatment of Autoimmune Neurosensory Hearing Loss
Conditions: Autoimmune Neurosensory Hearing Loss (ANSHL)
Summary: This study is an open label proof of concept study of rilonacept for patients with ANSHL
Interventions:
description: All patients will receive rilonacept with an initial loading dose of 320 mg delivered as two, 2-mL, subcutaneous injections of 160 mg each given on the same day at two different sites. The initial dose will be administered at the study site by study personnel. Dosing will then be a once-weekly injection of 160 mg administered as a single, 2-mL, subcutaneous injection by the patient at home. Patients will be dosed for 24 weeks.
name: Rilonacept
other_name: Arcalyst
IL-1 Trap
type: Drug
Study arms:
design_group_description: A loading dose of 320 mg the first dose then be a once-weekly injection of 160 mg for 24 weeks
design_group_title: Rilonacept
design_group_type: Experimental
Sponsor: Metroplex Clinical Research Center
Collaborators: Regeneron Pharmaceuticals, Inc.
Drug name mappings:
name: 利纳西普
lang: CN
name: Rilonacept
lang: EN
Clinical trial NCT00585156: The Effects of Celecoxib on Bone Ingrowth
Official title: The Effects of Celecoxib on Bone Ingrowth in Porous Coated Titanium Ceramic Implants in Humans
Conditions: Bone Ingrowth
Pain
Summary: The purpose of this study is to evaluate the effect of Celebrex on bone growth into porous coated implants, following postoperative total knee arthroplasty administration of Celebrex for pain relief.
Interventions:
description: Twelve hours prior to their first total knee surgery, patients will need to take an oral dose of Celebrex, 1 pill of 200mg. Following the patient's first total knee surgery, they will continue taking oral doses of Celebrex, 1 pill of 200 mg every twenty-four hours (200mg/day) for a two-week period.
name: Celecoxib
other_name: Celebrex
type: Drug
Study arms:
design_group_description: Celebrex treatment group
design_group_title: Arm #1
design_group_type: Experimental
Sponsor: University of Utah
Collaborators: Pfizer Inc.
Drug name mappings:
name: 塞来昔布
lang: CN
name: Celecoxib
lang: EN
name: セレコキシブ
lang: JP
Clinical trial NCT03979898: Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With CP
Official title: Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Cerebral Palsy (CP)
Conditions: Cerebral Palsy
Summary: Safety and Effectiveness of Autologous Adipose Tissue Derived mesenchymal Stem Cell Implantation in Patients with CP
Interventions:
description: Intravenous injection of Autologous Adipose derived mesenchymal stem cells. Dose : 15kg below : 0.5x10^7cells/5mL 15kg <br/> 25kg : 1x10^8cells/10mL 25kg over : 1.5x10^8cells/15mL
name: ASTROSTEM
other_name: Autologous Adipose Tissue Derived Mesenchymal Stem Cells
type: Biological
Study arms:
design_group_description: Autologous Adipose Tissue Derived Mesenchymal Stem Cells
design_group_title: Astrostem
design_group_type: Experimental
Sponsor: R Bio Co., Ltd.
Collaborators: Kyung Hee University Hospital at Gangdong
Drug name mappings:
name: Autologous Adipose Derived Mesenchymal Stem Cells(American CryoStem Co)
lang: EN
name: Autologous adipose tissue-derived mesenchymal stem cells (R Bio)
lang: EN
Clinical trial NCT06065189: Base-edited Autologous Hematopoietic Stem Cell Transplantation in Treating Patients With β-thalassemia Major
Official title: Evaluation and Promotion of Key Technologies of Base-edited Autologous Hematopoietic Stem Cell Transplantation in Treating Patients With β-thalassemia Major
Conditions: Beta-Thalassemia
Summary: The goal of this open label, single-arm clinical study is to learn about the safety and efficacy of base-edited autologous hematopoietic stem cell transplantation(CS-101) in treating patients with β-thalassemia major.
Interventions:
description: Autologous CD34+ hematopoietic stem cell suspension modified by in vitro base editing technique
name: CS-101 injection
type: Biological
Study arms:
design_group_description: Autologous CD34+(cluster of differentiation 34) hematopoietic stem cell suspension modified by in vitro base editing technique
design_group_title: CS-101 injection
design_group_type: Experimental
Sponsor: Paediatrics Hospital Affiliated To Fudan University
Collaborators: CorrectSequence Therapeutics Co., Ltd.
Drug name mappings:
name: CS-101
lang: EN
Clinical trial NCT00965666: Pilot Study of Etanercept (Enbrel) in Children With Fanconi Anemia
Official title: Etanercept (Enbrel) in Children With Fanconi Anemia and Early Bone Marrow Failure: A Pilot Study
Conditions: Fanconi Anemia
Summary: The purpose of this research study is to evaluate the safety of the drug Etanercept (Enbrel) and to determine if this drug can help in the treatment of early bone marrow failure in patients with Fanconi anemia.
Interventions:
description: All qualified subjects receive 24 weekly subcutaneous injections of Etanercept.
name: Etanercept
other_name: Enbrel
type: Drug
Study arms:
design_group_title: Open Label
design_group_type: Experimental
Sponsor: Children's Hospital & Medical Center
Collaborators: Amgen, Inc.
Drug name mappings:
name: 依那西普
lang: CN
name: Etanercept
lang: EN
name: エタネルセプト（遺伝子組換え）
lang: JP
Clinical trial NCT01852071: Autologous CD34+ Hematopoietic Stem Cells Transduced ex Vivo With Elongation Factor 1 Alpha Shortened (EFS) Lentiviral Vector Encoding for the Human ADA Gene
Official title: Autologous Transplantation of Bone Marrow CD34+ Stem/Progenitor Cells After Addition of a Normal Human ADA Complementary DNA (cDNA) by the EFS-ADA Lentiviral Vector for Severe Combined Immunodeficiency Due to Adenosine Deaminase Deficiency (ADA-SCID)
Conditions: ADA-SCID
Summary: The aim of this study is to assess the safety and efficacy of autologous transplantation of hematopoietic stem cells (CD34+ cells) from the bone marrow (BM) of ADA-deficient SCID infants and children following human ADA cDNA transfer by the EFS-ADA lentiviral vector. The level of gene transfer in blood cells and immune function will be measured as endpoints.
Interventions:
description: autologous EFS-ADA LV CD34+ cells (OTL-101) are infused intravenously
name: Infusion of autologous EFS-ADA LV CD34+ (OTL-101)
other_name: OTL-101
type: Genetic
description: Busulfan is used for non-myeloablative conditioning
name: busulfan
type: Drug
description: PEG-ADA ERT is discontinued at Day +30 (-3/+15 days) after successful engraftment
name: PEG-ADA ERT
type: Drug
Study arms:
design_group_description: Infusion of autologous EFS-ADA Lentiviral (LV) CD34+ cells
design_group_title: Gene Therapy
design_group_type: Experimental
Sponsor: University of California, Los Angeles
Collaborators: National Heart, Lung & Blood Institute
National Human Genome Research Institute
National Institute of Allergy & Infectious Diseases
Orchard Therapeutics Plc
Drug name mappings:
name: 白消安
lang: CN
name: Busulfan
lang: EN
name: ブスルファン
lang: JP
name: OTL-101
lang: EN
name: Pegademase
lang: EN
Clinical trial NCT02425748: Safety and Efficiency of γδ T Cell Against Non Small Lung Cancer ( Without EGFR Mutation)
Official title: γδ T Cell Immunotherapy for Treatment of
Conditions: Lung Cancer
Summary: In this study, effects of γδT cells on human non small lung cancer ( without EGFR mutation) in combination with tumor reducing surgery, for example cryosurgery going to be investigated.
Interventions:
description: DC-CIK cells will be used against tumor cells.
name: DC-CIK
type: Biological
description: γδ T cells will be used against non small lung tumor.
name: γδ T Cell
type: Biological
description: γδ T/DC-CIK cells will be used against lung tumor.
name: γδ T/DC-CIK cells
type: Biological
Study arms:
design_group_description: DC-CIK cells will be used against tumor cells.
design_group_title: Group A
design_group_type: Experimental
design_group_description: γδ T cells will be used against tumor cells.
design_group_title: Group B
design_group_type: Experimental
design_group_description: Combination of γδ T cells/ DC-CIK be used against tumor cells.
design_group_title: Group C
design_group_type: Experimental
Collaborators: Jinan University
Drug name mappings:
name: DC-CIK(Fuda Cancer Hospital)
lang: EN
name: γδ T Cell(Fuda Cancer Hospital)
lang: EN
Clinical trial NCT01989897: Effect of HSA or Saline Diluent on Immunotherapy Extract Stability as Determined by Graded ID Skin Tests
Official title: Effect of HSA or Saline Diluent on Immunotherapy Extract Stability as Determined by Graded ID Skin Tests
Conditions: Allergic Rhinitis
Summary: This is a double-blind study with respect to the diluents used, with patients known to be allergic to the specific allergen tested. Three study sites will be involved, each testing one allergen (Cat, Mite, Timothy grass pollen). Subjects who are known to be allergic to the allergen in question will be tested with serial three-fold dilutions to determine the ID 50 and relative extract potency using the method described by Turkeltaub.
Interventions:
name: saline with 1mg/ml Histamine base
type: Drug
name: diluent, saline with HSA--phenol
other_name: HSA 300mcg/ml (0.03%) and Saline
type: Drug
Study arms:
design_group_description: Negative control = diluent, saline with HSA--phenol Positive control = saline with 1mg/ml Histamine base
design_group_title: diluents
design_group_type: Experimental
Sponsor: The Ohio State University
Collaborators: American College of Allergy Asthma & Immunology
Drug name mappings:
name: 盐酸组胺
lang: CN
name: Histamine Dihydrochloride
lang: EN
Clinical trial NCT04863885: Combination of Ipi/Nivo Plus Sacituzumab Govitecan in Metastatic Cisplatin Ineligible Urothelial Carcinoma Patients
Official title: Phase I/II Study of Ipilimumab Plus Nivolumab (IPI-NIVO) Combined With Sacituzumab Govitecan (SG)as First-line Treatment for Cisplatin-ineligible Metastatic Urothelial Carcinoma
Conditions: Metastatic Urothelial Carcinoma
Summary: The purpose of this study is to see how well the study drugs called Ipilimumab plus Nivolumab (IPI-NIVO) work when added to another study drug called Sacituzumab Govitecan for people who have metastatic bladder cancer.
Interventions:
description: Participants will receive Ipilimumab 3 mg/kg
name: Ipilimumab
other_name: Yervoy
type: Drug
description: Participants will receive Nivoumab 1mg/kg
name: Nivolumab
other_name: Opdivo
type: Drug
description: Participants will be treated at 1 of 2 dose levels of Sacituzumab govitecan, either at 8 mg/kg, 10 mg/kg, or 6 mg/kg.
name: Sacituzumab govitecan
other_name: Trodelvy
type: Drug
Study arms:
design_group_description: Participants will be treated at dose level 1: Ipilumumab 3mg/kg + Nivolumab 1mg/kg IV day 1 every 3 weeks for 4 cycles, followed by Nivolumab 360 mg every 3 weeks. Sacituzumab Govitecan 8 mg/kg IV will be administered days 1 and 8 every 3 weeks.
design_group_title: Phase 1 Dose Level 1
design_group_type: Experimental
design_group_description: Participants will be treated at dose level 2: Ipilumumab 3mg/kg + Nivolumab 1mg/kg IV day 1 every 3 weeks for 4 cycles, followed by Nivolumab 360 mg every 3 weeks. Sacituzumab Govitecan 10 mg/kg IV will be administered days 1 and 8 every 3 weeks.
design_group_title: Phase 1 Dose Level 2
design_group_type: Experimental
design_group_description: If dose reduction is indicated, participants will be treated at dose level -1: Ipilumumab 3mg/kg + Nivolumab 1mg/kg IV day 1 every 3 weeks for 4 cycles, followed by Nivolumab 360 mg every 3 weeks. Sacituzumab Govitecan 6 mg/kg IV will be administered days 1 and 8 every 3 weeks
design_group_title: Phase 1 Dose Level -1
design_group_type: Experimental
design_group_description: Participants will be treated at with Ipilumumab 3mg/kg + Nivolumab 1mg/kg IV day 1 every 3 weeks for 4 cycles, followed by Nivolumab 360 mg every 3 weeks plus the maximum tolerated dose of Sacituzumab Govitecan days 1 and 8 every 3 weeks.
design_group_title: Phase 2: Treatment at Maximum Tolerated Dose (MTD)
design_group_type: Experimental
Sponsor: H. Lee Moffitt Cancer Center & Research Institute, Inc.
Collaborators: Bristol Myers Squibb Co.
Gilead Sciences, Inc.
Drug name mappings:
name: 伊匹木单抗
lang: CN
name: Ipilimumab
lang: EN
name: イピリムマブ（遺伝子組換え）
lang: JP
name: 纳武利尤单抗
lang: CN
name: Nivolumab
lang: EN
name: ニボルマブ（遺伝子組換え）
lang: JP
name: 戈沙妥组单抗
lang: CN
name: Sacituzumab govitecan-hziy
lang: EN
name: サシツズマブ ゴビテカン
lang: JP
Clinical trial NCT07128381: Phase I/II Clinical Trial of Axatilimab, a CSF1R Monoclonal Antibody, in Combination With Ruxolitinib as Therapy for Patients With Myelofibrosis (MF) and Chronic Myelomonocytic Leukemia (CMML)
Official title: Phase I/II Clinical Trial of Axatilimab, a CSF1R Monoclonal Antibody, in Combination With Ruxolitinib as Therapy for Patients With Myelofibrosis (MF) and Chronic Myelomonocytic Leukemia (CMML)
Conditions: Myelofibrosis (MF)
Chronic Myelomonocytic Leukemia (CMML)
Summary: * To find the recommended dose of axatilimab given alone and in combination with ruxolitinib in patients with MF and CMML.
* To learn if axatilimab given in combination with ruxolitinib can help to control MF and CMML.
Interventions:
description: Taken orally
name: Axatilimab (SNDX-6352)
type: Drug
description: Taken orally
name: Ruxolitinib
type: Drug
Study arms:
design_group_description: Participants will self-administered approximately 12 hours apart without regard to food
design_group_title: Monotherapy or Combination: Treatment with Axatilimab +/- Ruxolitinib IV Q4W
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: Incyte Corp.
Drug name mappings:
name: 艾克利单抗
lang: CN
name: Axatilimab-csfr
lang: EN
name: アキサチリマブ（遺伝子組換え）
lang: JP
name: 磷酸芦可替尼
lang: CN
name: Ruxolitinib  Phosphate
lang: EN
name: ルキソリチニブリン酸塩
lang: JP
Clinical trial NCT00405821: Acyclovir to Treat Patients Co-infected With HIV and Herpes Viruses in Uganda
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Acyclovir Prophylaxis Versus Placebo Among HIV-1/HSV-2 Co-Infected Individuals in Uganda
Conditions: HIV Infections
Herpes Genitalis
Summary: This study will determine whether acyclovir, a medicine used to treat herpes simplex virus 2 (HSV-2), can slow down the progression (worsening) of HIV disease in people with both HIV and HSV-2 infections. HSV-2 increases the amount of HIV virus in the blood of infected people and may make HIV progress faster. The study will evaluate:
"Whether people who take acyclovir can avoid antiretroviral treatment until later in their lives
"Whether people who take acyclovir get fewer genital ulcers
"How well people are able to take acyclovir and any side effects they experience from it
"Differences in the amount of HIV virus in the blood of patients who are and are not taking acyclovir, and how HIV/AIDS is different in these patients.
People 18 years of age and older living in the Rakai district of Uganda who are infected with both HIV (early stage disease) and HSV-2 may be eligible for this study. Participants are randomly assigned to take the study drug, acyclovir, or a placebo (look-alike pill with no active ingredient) daily for 2 years. During this time, they visit the clinic once a month for a routine physical examination. Patients who develop genital ulcers or complications of HIV are treated for the problem, and patients whose HIV disease progresses, requiring them to begin antiretroviral therapy, are treated accordingly.
Interventions:
description: 400mg twice daily for 24 months
name: Acyclovir
type: Drug
description: Placebo tablet twice daily for 24 months
name: Placebo
type: Drug
Study arms:
design_group_title: Acyclovir 400mg tablet twice daily
design_group_type: Active Comparator
design_group_title: Placebo tablet twice daily
design_group_type: Placebo Comparator
Sponsor: National Institute of Allergy & Infectious Diseases
Collaborators: The Johns Hopkins University
Translational Genomics Research Institute
University of Washington
Drug name mappings:
name: 阿昔洛韦
lang: CN
name: Acyclovir
lang: EN
name: アシクロビル
lang: JP
Clinical trial NCT00041028: EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
Official title: Pilot Phase II Research Study of EF5 to Measure Tumor Hypoxia in Patients With Non-Small Cell Lung Cancer
Conditions: Lung Cancer
Summary: RATIONALE: Knowing the level of oxygen in tumor tissue may help predict the effectiveness of anticancer therapy. EF5 is a drug used in the measurement of oxygen in tumor tissue.
PURPOSE: Phase II trial to study the effectiveness of EF5 in assessing tumor response to anticancer therapy in patients who have stage I, stage II, or stage III non-small cell lung cancer.
Interventions:
name: EF5
type: Drug
name: flow cytometry
type: Other
name: immunohistochemistry staining method
type: Other
Study arms:
Sponsor: Duke University
Collaborators: National Cancer Institute
Drug name mappings:
name: NSC-684681
lang: EN
Clinical trial NCT04850898: Study of SAB-176 in Healthy Adult Participants
Official title: A Phase 2a, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Treatment Efficacy of SAB-176 (a Quadrivalent Anti-seasonal Influenza Immunoglobulin Product) in an H1N1 Challenge Model in Healthy Adult Participants
Conditions: Influenza A H1N1
Summary: Healthy adult participants will be challenged with the H1N1 Influenza virus and then treated with either SAB-176 or placebo.
Interventions:
description: Treatment of influenza
name: SAB-176
type: Biological
description: Placebo Control
name: Placebo
type: Other
Study arms:
design_group_description: Placebo control dosed 1 time via intravenous infusion
design_group_title: Normal Saline Placebo Control
design_group_type: Placebo Comparator
design_group_description: Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion
design_group_title: SAB-176 - 25mg/kg
design_group_type: Experimental
Sponsor: SAB Biotherapeutics, Inc.
Collaborators: hVIVO Holdings Ltd.
Drug name mappings:
name: SAB-176
lang: EN
Clinical trial NCT00015951: Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers
Official title: A Phase II Study of the Recombinant Human Monoclonal Anti-Vascular Endothelial Growth Factor Antibody (rhuMAB VEGF) Bevacizumab (NSC #704865, IND # 7,921) Administered in Times Sequential Combination With Cytosine Arabinoside (Ara-C) and Mitoxantrone for Adults With Refractory and Relapsed Acute Myelogenous Leukemias (AMLs)
Conditions: Leukemia
Myelodysplastic Syndromes
Summary: RATIONALE: Monoclonal antibodies such as bevacizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may be an effective treatment for hematologic cancer.
PURPOSE: Phase II trial to study the effectiveness of bevacizumab combined with cytarabine and mitoxantrone in treating patients who have hematologic cancer.
Interventions:
name: bevacizumab
type: Biological
name: cytarabine
type: Drug
name: mitoxantrone hydrochloride
type: Drug
Study arms:
Sponsor: University of Maryland Baltimore
Collaborators: National Cancer Institute
University of Maryland Greenebaum Cancer Center
Drug name mappings:
name: 盐酸米托蒽醌
lang: CN
name: Mitoxantrone Hydrochloride
lang: EN
name: ミトキサントロン塩酸塩
lang: JP
name: 贝伐珠单抗
lang: CN
name: Bevacizumab
lang: EN
name: ベバシズマブ（遺伝子組換え）
lang: JP
name: 阿糖胞苷
lang: CN
name: Cytarabine
lang: EN
name: シタラビン
lang: JP