PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT00296023: Donor Stem Cell Transplant in Treating Older or Frail Patients With Hematologic Cancer
Official title: Low-Dose Allogeneic Peripheral Blood Stem Cell Transplantation for High-Risk Low Grade Hematologic Malignancies
Conditions: Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Summary: RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and methotrexate and tacrolimus after the transplant may stop this from happening.
PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant in treating older or frail patients with hematologic cancer.
Interventions:
name: anti-thymocyte globulin
type: Biological
name: filgrastim
type: Biological
name: therapeutic allogeneic lymphocytes
type: Biological
name: busulfan
type: Drug
name: fludarabine phosphate
type: Drug
name: methotrexate
type: Drug
name: tacrolimus
type: Drug
name: nonmyeloablative allogeneic hematopoietic stem cell transplantation
type: Procedure
name: peripheral blood stem cell transplantation
type: Procedure
Study arms:
design_group_title: stem cell transplant
design_group_type: Experimental
Sponsor: The University of California, San Francisco
Collaborators: National Cancer Institute
Drug name mappings:
name: 白消安
lang: CN
name: Busulfan
lang: EN
name: ブスルファン
lang: JP
name: 磷酸氟达拉滨
lang: CN
name: Fludarabine Phosphate
lang: EN
name: フルダラビンリン酸エステル
lang: JP
name: Allogeneic lymphocytes(Sidney Kimmel Cancer Center at Thomas Jefferson University)
lang: EN
name: 抗人胸腺细胞免疫球蛋白
lang: CN
name: Anti-thymocyte Globulin (Rabbit)
lang: EN
name: 抗ヒト胸腺細胞ウサギ免疫グロブリン
lang: JP
name: 非格司亭 （安进）
lang: CN
name: Filgrastim (Amgen)
lang: EN
name: フィルグラスチム（遺伝子組換え）
lang: JP
name: 他克莫司
lang: CN
name: Tacrolimus
lang: EN
name: タクロリムス水和物
lang: JP
name: 甲氨蝶呤
lang: CN
name: Methotrexate
lang: EN
name: メトトレキサート
lang: JP
Clinical trial NCT07363954: To Evaluate the Safety and Tolerability of STR-P004 for the Treatment of Immune-mediated Kidney Diseases
Official title: A Clinical Study on the Safety, Efficacy, and Pharmacokinetics of STR-P004 for the Treatment of Immune-Mediated Kidney Diseases
Conditions: Autoimmune Diseases
Summary: This is a single-center, non-randomized, open-label, single-arm exploratory clinical study, using Bayesian Optimal Interval (BOIN) design. Three dose groups are planned: DL1 XX mg/kg, DL2 XXmg/kg, DL3 XXmg/kg. Starting dose is XX mg/kg. Each treatment cycle is 28 days, with 4 infusions on D1, D4, D7, D10; 1-2 cycles. The investigator may escalate to higher doses to further explore safety and efficacy of STR-P004 based on preliminary safety data, efficacy information, and PK/PD parameters obtained.
Interventions:
description: Three dose groups are planned: DL1 XXmg/kg, DL2 XXmg/kg, DL3 XX mg/kg. Starting dose is XX mg/kg.
name: STR-P004 dose group
type: Drug
Study arms:
design_group_title: Dose1
design_group_type: Experimental
Sponsor: Starna therapeutics
Collaborators: Zhongshan Hospital Fudan University
Drug name mappings:
name: STR-P004
lang: EN
Clinical trial NCT00655980: Vitamins in Nitrous Oxide Study
Official title: Pharmacogenetics of Adverse Outcomes After Nitrous Oxide Anesthesia
Conditions: Major Surgery
Coronary Artery Disease
Summary: In this study, we want to find out if laughing gas (nitrous oxide) leads to a higher rate of cardiac complications after surgery in patients with a specific genetic profile (mutations in the MTHFR gene) and if this risk can be prevented by giving patients vitamin B12 and folate during surgery.
Interventions:
description: 1 mg vitamin B12 IV 5 mg folic acid IV in 100 ml NS infusion
name: Vitamin B12 and folic acid
type: Drug
name: Nitrous oxide and placebo
type: Drug
name: standard of care
type: Other
Study arms:
design_group_description: Vitamin B12 and folic acid
design_group_title: Treatment
design_group_type: Experimental
design_group_description: Nitrous oxide and placebo
design_group_title: Comparator
design_group_type: Placebo Comparator
design_group_description: standard of care
design_group_title: Standard of care
design_group_type: Other
Sponsor: Washington University School of Medicine
Collaborators: National Institute of General Medical Sciences
Foundation For Anesthesia Education & Research
Drug name mappings:
name: 盐酸硫胺素
lang: CN
name: Thiamine Hydrochloride
lang: EN
name: チアミン塩化物塩酸塩
lang: JP
name: 叶酸
lang: CN
name: Folic Acid
lang: EN
Clinical trial NCT01404871: Predicting Medication Response in Obsessive Compulsive Disorder
Official title: Predicting Medication Response in Obsessive Compulsive Disorder
Conditions: Obsessive Compulsive Disorder
Summary: In this study, the investigators hope to study a number of variables the investigators believe may help us predict why some people respond better to some medications than others. Participants will be randomly assigned to receive one of two typical medications for OCD, clomipramine or escitalopram. Individuals who would like to participate but who have previously tried one or both of these medications may instead take a newer drug, duloxetine, and undergo the identical procedures. The factors the investigators will be studying include demographics (i.e. age, gender, age of onset of OCD), genetic markers (such as variants in genes involved in breaking down drugs in the liver (cytochrome P450 system), and genes involved in several brain chemical systems, such as serotonin), the dimensions of OCD symptoms (i.e. checking, washing, and hoarding) and cortical inhibition. Cortical inhibition will be measured transcranial magnetic stimulation and is being studied because deficits in this process may be important in the development of OCD. The investigators hypothesize that certain pretreatment clinical characteristics will correlate with poor treatment response including earlier age of onset, longer duration of illness, increased YBOCS severity and presence of significant hoarding symptoms. The investigators expect that increasing degree of deficit in CI pre-treatment will predict poor treatment response, but that increase in CI from pre- to post-treatment will correlate with a positive treatment response. Differences in genetic marker status for cytochrome P450 genes will correlate with tolerability and/or response, as well as differences in genetic marker status in SLC1A1, GRIN2B, 5HT1B and 5HT2A will correlate with response.
Interventions:
description: oral tablets, starting at 50mg/daily for 12 weeks including > 8 weeks at 250 mg/daily
name: clomipramine
other_name: Anafranil
type: Drug
description: oral tablet, starting 10mg/daily 12 week treatment including >8 weeks at max dose 50mg daily
name: escitalopram
other_name: Cipralex
type: Drug
description: oral tablets, starting dose 30mg daily 12 week treatment including >8weeks at 120mg daily
name: duloxetine
other_name: Cymbalta
type: Drug
Study arms:
design_group_description: Randomized trial of clomipramine or escitalopram
design_group_title: Randomization to ECIT or CMI
design_group_type: Active Comparator
design_group_description: Open label trial of duloxetine
design_group_title: Open label Duloxetine
design_group_type: Active Comparator
Sponsor: Sunnybrook Health Sciences Centre
Collaborators: Centre for Addiction & Mental Health
Obsessive-Compulsive Foundation
Drug name mappings:
name: 草酸艾司西酞普兰
lang: CN
name: Escitalopram Oxalate
lang: EN
name: エスシタロプラムシュウ酸塩
lang: JP
name: 盐酸度洛西汀
lang: CN
name: Duloxetine Hydrochloride
lang: EN
name: デュロキセチン塩酸塩
lang: JP
name: 盐酸氯米帕明
lang: CN
name: Clomipramine Hydrochloride
lang: EN
name: クロミプラミン塩酸塩
lang: JP
Clinical trial NCT04121728: Modulation of Attention in Event Related Potential (ERPs) as a Marker of Early Cognitive Decline by Ginkgo Biloba
Official title: Evaluation of the Modulation of Attention Explored in ERPs as a Marker of Early Cognitive Decline: Concept Validation on the Effect of Ginkgo Biloba Extracts. Randomized, Double-blind, Cross-over, Placebo-controlled Study
Conditions: Subjective Cognitive Decline
Cognitive Performance
Functional Capacity
Age-related Cognitive Decline
Summary: The objective of this study is to simultaneously establish the metrological characteristics of the new executive function markers (decision making and multiple flow management) derived from repeated ERP variations and to identify their ability to test whether a short treatment using Ginkgo biloba versus placebo extracts can modify the cognitive performance and functional capacity of patients in the very early stages of age-related cognitive decline. This trial, using subjects as their own control (cross-over) in repeated measurements will establish the reproducibility characteristics of the measurements and intra-individual variations of ERP over time in this population
Interventions:
description: Symfona® commercial standardized Ginkgo biloba extracts are used in this study, at a rate of 2 capsules of 120 mg per day for 170 days.
name: Ginkgo biloba extract
other_name: Symfona®
type: Drug
description: The placebo is presented in the form of capsules of identical mass, color and shape to those of the study product. It is composed of lactose, the excipients present in Symfona® 120 mg and colorants. The dosage is identical to that of the investigational product.
name: Placebo
other_name: Placebo caps
type: Drug
Study arms:
design_group_description: Cross-over design: In Group Ginkgo-Placebo participants are allocated first to the IMP Symfona® during 6 months and after 2 months of wash-out period are allocated to the placebo for 6 months.
design_group_title: Group Ginkgo-Placebo
design_group_type: Other
design_group_description: Cross-over design:In Group Placebo-Ginkgo participants are allocated first to the placebo during 6 months and after 2 months of wash-out period are allocated the IMP Symfona® for 6 months.
design_group_title: Group Placebo-Ginkgo
design_group_type: Other
Sponsor: Centre Hospitalier Universitaire Vaudois
Collaborators: Centre Hospitalier Universitaire Vaudois
Drug name mappings:
name: 银杏叶提取物
lang: CN
name: Extract of Ginkgo Biloba Leaves
lang: EN
Clinical trial NCT03000075: BI 655066 (Risankizumab) Compared to Placebo in Japanese Patients With Moderate to Severe Chronic Plaque Psoriasis
Official title: A Phase II/III, Randomized, Double-blind Study to Evaluate Efficacy and Safety of Two Different Dose Regimens of BI 655066 (Risankizumab) and Placebo and Maintenance of Response of BI 655066 (Risankizumab) Administered Subcutaneously in Japanese Patients With Moderate to Severe Chronic Plaque Type Psoriasis.
Conditions: Psoriasis
Summary: This is a randomized double blind, double dummy, placebo controlled, parallel design study that is being performed to assess the safety and efficacy of BI 655066 (risankizumab).
Interventions:
description: Risankizumab pre-filled syringe, administered by subcutaneous (SC) injection
name: risankizumab
other_name: ABBV-066
BI 655066
type: Drug
description: Placebo for risankizumab pre-filled syringe, administered by subcutaneous (SC) injection
name: placebo for risankizumab
type: Drug
Study arms:
design_group_description: Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
design_group_title: Placebo (Part A)
design_group_type: Placebo Comparator
design_group_description: Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
design_group_title: Risankizumab 75 mg (Part A)
design_group_type: Experimental
design_group_description: Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
design_group_title: Risankizumab 150 mg (Part A)
design_group_type: Experimental
Sponsor: AbbVie, Inc.
Collaborators: Boehringer Ingelheim GmbH
Drug name mappings:
name: 利生奇珠单抗
lang: CN
name: Risankizumab-RZAA
lang: EN
name: リサンキズマブ（遺伝子組換え）
lang: JP
Clinical trial NCT05913661: Pemigatinib Combined With PD-1 Inhibitor in Unresectable or Metastatic Intrahepatic Cholangiocarcinoma
Official title: Prospective, Single-arm, Multicenter Phase II Study of Evaluation of the Efficacy and Safety of Pemigatinib Combined With PD-1 Inhibitor in First-line Treatment of Unresectable or Metastatic Intrahepatic Cholangiocarcinoma
Conditions: Carcinoma
Intrahepatic Cholangiocarcinoma
Digestive System Neoplasms
PD-1 Inhibitor
First-line Treatment
Summary: This is a Prospective, single-arm, phase II study with multicenter participation. The objective of this study is to evaluate the efficacy and safety of pemigatinib combined with PD-1 inhibitor as first-line treatment for patients with advanced unresectable or metastatic intrahepatic cholangiocarcinoma.
Interventions:
description: Pemigatinib is scheduled to be administered at a dose of 13.5 mg quaque die according to a 2-week dosing and 1-week discontinuation regimen.
name: Pemigatinib
other_name: Pemazyre
type: Drug
description: The dosing regimen is 200 mg IV Q3W
name: PD-1 Inhibitors
other_name: Sintilimab
type: Drug
Study arms:
design_group_description: pemigatinib combined with PD-1 inhibitor as first-line treatment within advanced unresectable or metastatic intrahepatic cholangiocarcinoma
design_group_title: pemigatinib combined with PD-1 inhibitor
design_group_type: Experimental
Sponsor: Sun Yat-Sen Memorial Hospital
Collaborators: The First Affiliated Hospital of Jinan University
Drug name mappings:
name: 信迪利单抗
lang: CN
name: Sintilimab
lang: EN
name: 佩米替尼
lang: CN
name: Pemigatinib
lang: EN
name: ペミガチニブ
lang: JP
Clinical trial NCT00003966: Defibrotide in Treating Patients With Liver Damage Following Peripheral Stem Cell Transplantation
Official title: Defibrotide for Hematopoietic Stem Cell Transplant Patients With Severe Hepatic Venocclusive Disease: A Phase I/II Study to Determine the Minimal Effective Dose
Conditions: Veno-occlusive Disease
Summary: RATIONALE: Giving defibrotide may be an effective treatment for liver damage that may result following peripheral stem cell transplantation.
PURPOSE: This randomized phase II trial is studying defibrotide to see how well it works in treating patients with severe liver disease after undergoing peripheral stem cell transplantation.
Interventions:
name: defibrotide
other_name: Defitelio®
type: Drug
Study arms:
design_group_description: This is a randomized, multicenter study. All patients initially receive the same dose of defibrotide IV over 2 hours every 6 hours on day 1. On day 2, patients are randomized to 1 of 2 doses of defibrotide.<br/>- Arm I: On days 2-14, patients receive a lower dose of defibrotide IV over 2 hours every 6 hours.<br/>In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
design_group_title: Arm A Lower dose
design_group_type: Experimental
design_group_description: This is a randomized, multicenter study. All patients initially receive the same dose of defibrotide IV over 2 hours every 6 hours on day 1. On day 2, patients are randomized to 1 of 2 doses of defibrotide.<br/>- Arm II: On days 2-14, patients receive a higher dose of defibrotide IV over 2 hours every 6 hours.<br/>In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
design_group_title: Arm B Higher Dose
design_group_type: Experimental
Sponsor: Dana-Farber Cancer Institute, Inc.
Collaborators: National Cancer Institute
Jazz Pharmaceuticals Plc
Drug name mappings:
name: 去纤苷钠
lang: CN
name: Defibrotide Sodium
lang: EN
name: デフィブロチドナトリウム
lang: JP
Clinical trial NCT00321802: Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins
Official title: Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins
Conditions: Atrial Fibrillation
Summary: The purpose of this study is to determine the effect of statin therapy for prevention of atrial fibrillation (AF) in pacemaker and non-pacemaker patients with paroxysmal atrial fibrillation in the absence of significant coronary artery disease.
Interventions:
description: Patients take 40 mg of simvastatin per day for 6 months.
name: Simvastatin
other_name: Zocor
type: Drug
description: Placebo
name: Placebo
type: Drug
Study arms:
design_group_description: Patients randomized to active drug, then AF burden and CRP values will be compared to those in placebo arm.
design_group_title: 1
design_group_type: Experimental
design_group_description: Patients take placebo once daily for 6 Months, then AF burden and CRP values will be compared to those in experimental arm.
design_group_title: 2
design_group_type: Placebo Comparator
Sponsor: University of Calgary
Collaborators: Merck Sharp & Dohme Corp.
Canadian Institutes of Health Research
Drug name mappings:
name: 辛伐他汀
lang: CN
name: Simvastatin
lang: EN
name: シンバスタチン
lang: JP
Clinical trial NCT00068341: Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer
Official title: Neoadjuvant Treatment and Molecular Characterization of Locally Advanced Breast Cancer
Conditions: Breast Cancer
Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether docetaxel and carboplatin are more effective with or without trastuzumab in treating breast cancer.
PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone before surgery in treating women with locally advanced breast cancer.
Interventions:
description: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
name: trastuzumab
other_name: Herceptin
type: Biological
description: Cycle 1-8 Day 1 or 2 AUC = 6 IV
name: carboplatin
type: Drug
description: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
name: docetaxel
other_name: Taxotere
type: Drug
description: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV<br/>Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV<br/>Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
name: trastuzumab
other_name: Herceptin
type: Biological
Study arms:
design_group_description: see intervention description
design_group_title: Arm I (neoadjuvant therapy)
design_group_type: Experimental
design_group_description: please see intervention description
design_group_title: Arm II (neoadjuvant therapy)
design_group_type: Experimental
design_group_description: please see intervention description
design_group_title: HER2/neu negative patients
design_group_type: Experimental
Sponsor: Jonsson Comprehensive Cancer Center
Collaborators: Genentech, Inc.
Aventis Pharmaceuticals, Inc.
Drug name mappings:
name: 曲妥珠单抗
lang: CN
name: Trastuzumab
lang: EN
name: トラスツズマブ（遺伝子組換え）
lang: JP
name: 卡铂
lang: CN
name: Carboplatin
lang: EN
name: カルボプラチン
lang: JP
name: 多西他赛
lang: CN
name: Docetaxel
lang: EN
name: ドセタキセル
lang: JP
Clinical trial NCT06036602: Monovalent Chimpanzee Adenoviral-Vectored Sudan Ebolavirus Vaccine in Healthy Adults
Official title: A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Sudan Ebolavirus Vaccine in Healthy Adults
Conditions: Ebola Sudan Virus Disease
Summary: A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Sudan Ebolavirus Vaccine in Healthy Adults
Interventions:
description: The recombinant chimpanzee adenovirus Type 3-vectored Sudan Ebolavirus vaccine, (cAd3-EBO S) is composed of a cAd3 vector that expresses wild type glycoprotein (WT GP) from the Sudan Gulu ebolavirus strain.
name: cAD3-Sudan Ebolavirus Vaccine
type: Biological
description: 0.9% NaCl solution for injection.
name: Placebo
type: Other
Study arms:
design_group_description: Single dose of cAd3-Sudan Ebolavirus vaccine (1x10^11 PU) administered intramuscularly (IM) with needle and syringe.
design_group_title: cAD3-Sudan Ebolavirus Vaccine
design_group_type: Experimental
design_group_description: 0.9% NaCl solution for injection)administered intramuscularly (IM) with needle and syringe in a volume of 0.56 mL
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Albert B. Sabin Vaccine Institute, Inc.
Collaborators: Biomedical Advanced Research & Development Authority (Barda)
Drug name mappings:
name: Ebola Sudan vaccine(Albert B. Sabin Vaccine Institute)
lang: EN
Clinical trial NCT04715763: INvestigating TELmisartin Study
Official title: Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Treatment of COVID-19 in Hospitalized Patients
Conditions: Covid19
Summary: This study will enroll 40 inpatients hospitalized for COVID-19 at Queens' Medical Center. Participants will be randomized 1:1 to Telmisartan (80 mg) vs placebo to be administered orally once daily x 21 days.
Interventions:
description: Angiotensin Receptor Blocker (ARB) FDA approved for use in hypertension and for cardiovascular risk reduction
name: Telmisartan Oral Product
other_name: Micardis
type: Drug
description: Gelatin capsules filled with an inactive ingredient
name: Placebo
type: Drug
Study arms:
design_group_description: Telmisartan 80 mg (given as two 40 mg encapsulated tablets) given orally each day x 21 days
design_group_title: Telmisartan (80 mg)
design_group_type: Active Comparator
design_group_description: Two placebo capsules given orally each day x 21 days
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University of Hawaii System
Collaborators: The Queen's Medical Center
Drug name mappings:
name: 替米沙坦
lang: CN
name: Telmisartan
lang: EN
name: テルミサルタン
lang: JP