PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT00083759: Natalizumab in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate
Official title: A Phase II, Multicenter, Double-blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Intravenous Natalizumab (300 mg) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Receiving Concomitant Treatment With Methotrexate (MTX)
Conditions: Rheumatoid Arthritis
Summary: The purpose of this study is to determine the safety, tolerability and efficacy of natalizumab in subjects diagnosed with moderate to severe rheumatoid arthritis (RA) receiving concomitant treatment with methotrexate (MTX). It is thought that natalizumab may stop the movement of certain white blood cells, known as lymphocytes, into joint tissue. These cells are thought to cause damage in the joints leading to the symptoms of RA.
Interventions:
name: natalizumab
other_name: TYSABRI
type: Drug
name: placebo
type: Drug
Study arms:
design_group_title: natalizumab
design_group_type: Active Comparator
design_group_title: placebo
design_group_type: Placebo Comparator
Sponsor: Biogen, Inc.
Collaborators: Elan Corp. Plc
Drug name mappings:
name: 那他珠单抗
lang: CN
name: Natalizumab
lang: EN
name: ナタリズマブ（遺伝子組換え）
lang: JP
Clinical trial NCT02594098: Secukinumab for Treatment of Atopic Dermatitis
Official title: A Pilot Study to Evaluate the Efficacy and Safety of Secukinumab in the Treatment of Moderate to Severe Atopic Dermatitis
Conditions: Atopic Dermatitis
Summary: Atopic Dermatitis, also known as atopic eczema, or eczema, is a common skin disease that can affect males and females of all ages, but often starts in childhood. Recent studies show at least 4-7% of adults and 15-25% of children to be affected, with one third of patients having severe disease. It results in very itchy, red, swollen, and cracked skin. Scratching worsens the symptoms and causes the skin to become thickened over time. Patients with atopic dermatitis have an increased risk of skin infections, and many also develop hay fever or asthma. Atopic dermatitis can cause significant distress to both patients and their families.
In this study, the aim is to assess the effects of a new treatment called secukinumab in patients with atopic dermatitis. A total of 30 patients will be included in the study, which will run for a total of 52 weeks.
Interventions:
description: At Weeks 0, 1, 2, 3, 4 and every 2 weeks thereafter through and including Week 12 in phase 1 of the study.
name: Secukinumab
type: Drug
description: At Weeks 0, 1, 2, 3, 4 and every 2 weeks thereafter through and including Week 12 in phase 1 of the study.
name: Placebo
type: Drug
Study arms:
design_group_description: Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes
design_group_title: Secukinumab
design_group_type: Experimental
design_group_description: Placebo via subcutaneous injection using 2 prefilled syringes
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Icahn School of Medicine at Mount Sinai
Collaborators: Novartis AG
Drug name mappings:
name: 司库奇尤单抗
lang: CN
name: Secukinumab
lang: EN
name: セクキヌマブ（遺伝子組換え）
lang: JP
Clinical trial NCT03075527: A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma
Official title: A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma
Conditions: Mesothelioma
Summary: This research study is studying a pair of immunotherapies as a possible treatment for malignant pleural mesothelioma.
The drugs involved in this study are:
* Durvalumab
* Tremelimumab
Interventions:
description: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.
name: Tremelimumab
other_name: CP-675,206
type: Drug
description: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.
name: Durvalumab
other_name: MEDI-4736
type: Drug
Study arms:
design_group_description: Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.
design_group_title: Tremelimumab + Durvalumab
design_group_type: Experimental
Sponsor: Dana-Farber Cancer Institute, Inc.
Collaborators: AstraZeneca PLC
Drug name mappings:
name: 曲麦利尤单抗
lang: CN
name: Tremelimumab
lang: EN
name: トレメリムマブ（遺伝子組換え）
lang: JP
name: 度伐利尤单抗
lang: CN
name: Durvalumab
lang: EN
name: デュルバルマブ（遺伝子組換え）
lang: JP
Clinical trial NCT03588754: Does Propranolol, a Beta Blocker, Attenuate Stress-Induced Drinking?
Official title: Does Propranolol, a Beta Blocker, Attenuate Stress-Induced Drinking?
Conditions: Alcohol Drinking
Summary: For this protocol, the investigators plan to conduct a pilot study evaluating the effect of propranolol on alcohol consumption. Using a parallel design, the investigators plan to randomize 20 non-treatment seeking adults with alcohol use disorders (DSM-5) to propranolol extended release (160mg/day or placebo; n=10 per cell) to evaluate whether propranolol reduces alcohol self-administered in the laboratory. Importantly, the investigators will evaluate whether propranolol counteracts stress-induced effects on alcohol self-administration. Following titration to steady state medication levels over a 2-week period, each subject will complete two laboratory sessions consisting of a well validated method for inducing stress or neutral/relaxing state (order counterbalanced), followed by a 2-hour alcohol self-administration paradigm known to be sensitive to medication effects.
Interventions:
description: Propranolol Extended Release (160mg/day).
name: Propranolol
type: Drug
description: Placebo pill administered orally.
name: Placebo
type: Drug
Study arms:
design_group_description: Propranolol extended release (160mg/day). Administered orally once daily at 10:00PM. Titration schedule Days 1-3 60mg, Days 4-7 80mg, Days 8-11 120mg, and Days 12-14 160mg until steady state.
design_group_title: Propranolol
design_group_type: Experimental
design_group_description: Administered orally once daily at 10:00PM
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Yale University
Collaborators: National Institute on Alcohol Abuse & Alcoholism
Drug name mappings:
name: 盐酸普萘洛尔
lang: CN
name: Propranolol Hydrochloride
lang: EN
name: プロプラノロール塩酸塩
lang: JP
Clinical trial NCT03768375: Molecularly Target Therapy With FORFIRINOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma
Official title: A Multicentre, Open-label, Randomised, Controlled Study of Molecularly Precision Target Therapy Based on Tumor Molecular Profiling With FORFIRINOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma
Conditions: Cholangiocarcinoma of the Extrahepatic Bile Duct
Gallbladder Cancer
Summary: The purpose of this study is to evaluate the feasibility, efficacy and safety of target therapy according to genomic and proteomic profiling combined with FORFIRINOX in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.
Interventions:
description: Drug: FORFIRINOX Conventional chemotherapy:gemcitabine and oxaliplatin Drug: Cetuximab Drug: Trastuzumab Drug: Gefitinib Drug: Lapatinib Drug: Everolimus Drug: Sorafenib Drug: Crizotinib
name: conventional chemotherapy(FORFIRINOX) combined with target agents
type: Biological
description: conventional chemotherapy(FORFIRINOX)
name: conventional chemotherapy(FORFIRINOX)
type: Biological
Study arms:
design_group_description: The patients wil receive conventional chemotherapy(FORFIRINOX) combined with target agents according to the result of genomic and proteomic profiling of tumor tissue.
design_group_title: target therap
design_group_type: Experimental
design_group_description: The patients wil receive conventional chemotherapy(FORFIRINOX)
design_group_title: FORFIRINOX
design_group_type: Experimental
Sponsor: Shanghai Jiao Tong University
Collaborators: Ruijin Hospital
Xinhua Hospital
Shanghai Renji Hospital Management Co., Ltd.
Shanghai Eastern Hepatobiliary Surgery Hospital
Shanghai Huashan Hospital
Drug name mappings:
name: 亚叶酸钙
lang: CN
name: Leucovorin Calcium
lang: EN
name: ホリナートカルシウム
lang: JP
name: 聚乙二醇伊立替康
lang: CN
name: PEG-Irinotecan
lang: EN
name: 奥沙利铂
lang: CN
name: Oxaliplatin
lang: EN
name: オキサリプラチン
lang: JP
name: 氟尿嘧啶
lang: CN
name: Fluorouracil
lang: EN
name: フルオロウラシル
lang: JP
Clinical trial NCT04432389: Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB®) Single Implantation in Tibial Fracture
Official title: Phase IIb, Placebo-Controlled, Randomized, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB®) Single Implantation in Tibial Fracture
Conditions: Tibial Fracture
Summary: Although the majority of tibial fractures heal normally, some fractures may not heal within the usual time frame and is known as delayed bone healing within 4 to 6 months and absence of bone healing within 9 to 12 months in the most severe case of. Several factors can increase the risks of delayed healing complications like, for example, smoking, violent shocks (for example, due to a road accident) or even the type of fracture (an open fracture). The location of the fracture is also an important factor: among the bones of the arms and legs, the tibia is known for being the most at risk for complications. At tibial fracture with several risk factors could lead to delayed complications and interfere with patient daily life and reduce the quality of life.
The study drug, ALLOB®, is constituted of bone cells produced from the bone marrow of healthy adult donors. Preclinical studies have shown that ALLOB® cells are capable of forming bone and repairing fractures. When directly injected into a fracture, ALLOB® should therefore promote the healing of the fracture by re-establishing a healthy environment and stimulating bone production. To date, there is no treatment for fractures considered at risk of delayed complications. The current practice on diagnosis of complications is to wait at least 6-12 months before considering alternative interventions to promote fracture healing. The injection of ALLOB® quickly after the fracture should stimulate bone healing, reduce healing time, reduce complications, and improve the quality of life for the patient. ALLOB® has already shown preliminary evidence of effectiveness in the treatment of delayed bone healing fractures (ALLOB-DU1 clinical trial), including tibial fractures (8 patients). With this study, the Sponsor will evaluate whether ALLOB® promotes the healing of tibial fractures compared with placebo.
Interventions:
description: After thawing, ALLOB® is a ready-to-use product for local administration at fracture site.
name: ALLOB
type: Biological
description: Placebo injected is a saline solution injectable grade (4 mL of 0.9% NaCl) filled in single-dose vial
name: placebo
type: Other
Study arms:
design_group_description: Single injection of ALLOB at fracture site (4 ml)
design_group_title: ALLOB
design_group_type: Experimental
design_group_description: Single injection of Placebo at fracture site (4 ml)
design_group_title: placebo
design_group_type: Placebo Comparator
Sponsor: Bone Therapeutics SA
Collaborators: ICON plc
Drug name mappings:
name: Allogeneic osteoblastic cell therapy (Bone Therapeutics)
lang: EN
Clinical trial NCT00024271: Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer
Official title: Phase II Trial Of Combined Resection, Intraperitoneal Chemotherapy, And Whole Abdominal Radiation For Treatment Of Peritoneal Mesothelioma
Conditions: Malignant Mesothelioma
Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs directly into the tumor after surgery and combining them with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining surgery, chemotherapy, and radiation therapy in treating patients who have peritoneal cancer.
Interventions:
name: recombinant interferon gamma
type: Biological
name: cisplatin
type: Drug
name: doxorubicin hydrochloride
type: Drug
name: gemcitabine hydrochloride
type: Drug
name: mitomycin C
type: Drug
name: conventional surgery
type: Procedure
name: hyperthermia treatment
type: Procedure
name: radiation therapy
type: Radiation
Study arms:
Sponsor: The Herbert Irving Comprehensive Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 丝裂霉素
lang: CN
name: Mitomycin
lang: EN
name: マイトマイシンC
lang: JP
name: 盐酸多柔比星
lang: CN
name: Doxorubicin Hydrochloride
lang: EN
name: ドキソルビシン塩酸塩
lang: JP
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
name: 顺铂
lang: CN
name: Cisplatin
lang: EN
name: シスプラチン
lang: JP
Clinical trial NCT02643654: MABp1 IN HIDRADENITIS SUPPURATIVA REFRACTORY TO ADALIMUMAB
Official title: A Double-blind, Randomised, Placebo-controlled Clinical Trial of the Efficacy of MABp1, a- First-in-class True Human Antibody Targeting Interleukin-1alpha, in Patients With Hidradenitis Suppurativa Not Eligible for antiTNF Therapy
Conditions: Hidradenitis Suppurativa
Summary: Hidradenitis suppurativa (HS) is a chronic inflammatory skin disorder. Although adalimumab is recently licensed for moderate to severe HS, many cases fail to respond or relapse during treatment. Favorable outcomes from a recently conducted double-blind randomized clinical study on the efficacy of anakinra, one interleukin(IL)-1alpha blocker, in hidradenitis suppurativa (HS), led to validate the efficacy of MABp1, a true human antiIL-1α antibody in these cases.
Interventions:
description: This is a sterile injectable liquid formulation of 50 mg/mL MABp1 in a stabilizing isotonic buffer (pH 6.4). Each 10-mL serum vial contains 6 ml of the formulation, and is sealed with a 20-mm grey bromobutyl stopper and flip-off aluminum seal
name: MABp1
type: Drug
description: The placebo dosage form is a sterile isotonic formulation buffer at pH 6.2-6.5. Each 10-ml Type I borosilicate glass serum vial contains 6mL of the formulation buffer, and is sealed with a 20-mm Daikyo Flurotec butyl rubber stopper and flip-off aluminum seal.
name: Placebo
type: Drug
Study arms:
design_group_description: The placebo product is manufactured following the same procedures and batch records used to manufacture the MABp1 drug product. The placebo dosage form is a sterile isotonic formulation buffer at pH 6.2-6.5. Each 10-ml Type I borosilicate glass serum vial contains 6mL of the formulation buffer, and is sealed with a 20-mm Daikyo Flurotec butyl rubber stopper and flip-off aluminum seal.
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: MABp1 is a recombinant human IgG1 monoclonal antibody specific for human interleukin-1α (IL-1α). The entire MABp1 heavy and light chain sequences are identical to those found in naturally-occurring human IgG1κ, with the light and heavy chain variable regions being identical to those originally expressed by a peripheral blood B lymphocyte that was obtained from a healthy individual. It is a sterile injectable liquid formulation of 50 mg/mL MABp1 in a stabilizing isotonic buffer (pH 6.4). Each 10-mL serum vial contains 6 ml of the formulation, and is sealed with a 20-mm grey bromobutyl stopper and flip-off aluminum seal
design_group_title: MABp1
design_group_type: Active Comparator
Sponsor: National & Kapodistrian University of Athens
Collaborators: Hellenic Institute for the Study of Sepsis
Drug name mappings:
name: 贝迈奇单抗(XBiotec)
lang: CN
name: Bermekimab
lang: EN
Clinical trial NCT01668173: HSP90 Inhibitor, AUY922, in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
Official title: A Phase II Study of the HSP90 Inhibitor, AUY922, in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
Conditions: Myeloproliferative Neoplasms
Summary: The purpose of this study is to test a new drug called AUY922. AUY922 is not FDA-approved. AUY922 is a new kind of drug that attacks a protein called HSP90. HSP90 is found in both normal and cancer cells, but the investigators think it is more important in cancer cells.
This study will see if AUY922 helps people with myelofibrosis, essential thrombocythemia and polycythemia vera. This study will also see if AUY922 is safe in people with myelofibrosis, essential thrombocythemia and polycythemia vera. It will find out what effects, good and/or bad, AUY922 has on the patient and the disease. The researchers hope that this study will help them to find better treatments for primary myelofibrosis, essential thrombocythemia and polycythemia vera.
Interventions:
description: AUY922 will be administered as an intravenous infusion over 60 minutes, on a once weekly schedule. A cycle on study will be defined as 28 days. The dose to be studied are 70 mg/m2 and 55 mg/m2 if DLTs are identified in the first 3-6 patients. The same schedule of administration will be used for all patients in this trial.
name: AUY922
type: Drug
Study arms:
design_group_description: This is an open-label phase II trial to assess the efficacy of the HSP90 inhibitor, AUY922, in patients with PMF, post-PV MF, post-ET MF, and with PV/ET who are refractory to hydroxyurea, phlebotomy or anagrelide.
design_group_title: AUY922
design_group_type: Experimental
Sponsor: Memorial Sloan Kettering Cancer Center
Collaborators: Novartis AG
Drug name mappings:
name: Luminespib
lang: EN
Clinical trial NCT02689869: Combination of PCI-32765 With Obinutuzumab in Untreated Follicular Lymphoma
Official title: A Chemotherapy-free Combination of the Bruton's Tyrosine Kinase Inhibitor, Ibrutinib in Combination With GA 101 in Patients With Previously Untreated Follicular Lymphoma and a High Tumor Burden
Conditions: Indolent Non-Hodgkin Lymphoma
Summary: Primary Objectives The primary objective of this study is to evaluate the efficacy of the chemotherapy-free combination of ibrutinib and obinutuzumab (GA 101) in patients with previously untreated follicular lymphoma (FL) and a high tumor burden. Primary endpoint to be observed for this is the rate of progression free survival one year after start of therapy.
Hypothesis The hypothesis of the study is that ibrutinib in combination with obinutuzumab will achieve response rates (CR and PR), rates of MRD negativity and PFS which are comparable to currently used standard rituximab-chemotherapy combinations such as R-CHOP or R-bendamustine in subjects with previously untreated FL and a high tumor burden.
Interventions:
description: Ibrutinib (PCI-32765; JNJ-54179060) is a first-in-class, potent, orally-administered covalently-binding small molecule inhibitor of Bruton's tyrosine kinase currently being co-developed by Janssen Research & Development, LLC and Pharmacyclics, Inc for the treatment of B-cell malignancies.
name: Ibrutinib
other_name: Imbruvica
type: Drug
description: Obinutuzumab (GA 101) is a first-in-class, potent, intravenously administered type II anti-CD 20 antibody that is developed by Roche AG for the treatment of B-cell malignancies.
name: GA 101
other_name: Obinutuzumab
type: Drug
Study arms:
design_group_description: Initial therapy 6 cycles of Ibrutinib:<br/>Ibrutinib 560 mg once daily every day until start of maintenance for a total of 24 weeks.<br/>1000 mg of GA101 I.V. on days d 1, 8, 15 of cycle 1 and on day 1 of cycles 2-6 (21 day cycles).<br/>Maintenance with another 24 months of ibrutinib plus GA101 in patients with clinical remission after the last induction cycle:<br/>Ibrutinib 560 mg once daily every day. GA101 at a dose of 1000 mg I.V. every 2 months for a total of 24 months. The total duration of ibrutinib plus obinutuzumab therapy will therefore be 30 months.<br/>In patients remaining MRD positive at 30 months without clinical progression, single agent ibrutinib therapy is continued for another 12 months.
design_group_title: Ibrutinib and GA 101
design_group_type: Experimental
Sponsor: Ludwig-Maximilians-Universität München
Collaborators: Janssen-Cilag GmbH
Hoffmann-La Roche, Inc.
Drug name mappings:
name: 伊布替尼
lang: CN
name: Ibrutinib
lang: EN
name: イブルチニブ
lang: JP
name: 奥妥珠单抗
lang: CN
name: Obinutuzumab
lang: EN
name: オビヌツズマブ（遺伝子組換え）
lang: JP
Clinical trial NCT02807805: Abiraterone Acetate, Niclosamide, and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer
Official title: A Phase II Study With a Lead-in Safety Phase of Abiraterone in Combination With PDMX1001/Niclosamide in Castration-Resistant Prostate Cancer (CRPC)
Conditions: Metastatic Prostate Carcinoma
Recurrent Prostate Carcinoma
Stage IV Prostate Cancer
Summary: This phase II trial studies the side effects and how well abiraterone acetate, niclosamide, and prednisone work in treating patients with hormone-resistant prostate cancer. Androgens can cause the growth of prostate cells. Hormone therapy using abiraterone acetate may fight prostate cancer by lowering the amount of androgen the body makes. Niclosamide is a drug that may block another signal that can cause prostate cancer cell growth. Prednisone is a drug that can help lessen inflammation. Giving abiraterone acetate, niclosamide, and prednisone may be a better treatment for patients with hormone-resistant prostate cancer.
Interventions:
description: Given PO
name: Abiraterone Acetate
other_name: CB7630
Zytiga
type: Drug
description: Given PO
name: Niclosamide
type: Drug
description: Given PO
name: Prednisone
other_name: .delta.1-Cortisone
1, 2-Dehydrocortisone
Adasone
Cortancyl
Dacortin
DeCortin
Decortisyl
Decorton
Delta 1-Cortisone
Delta-Dome
Deltacortene
Deltacortisone
Deltadehydrocortisone
Deltasone
Deltison
Deltra
Econosone
Metacortandracin
Meticorten
Ofisolona
Orasone
Panafcort
Panasol-S
Paracort
Predicor
Predicorten
Prednicen-M
Prednicort
Prednidib
Prednilonga
Predniment
Prednisonum
Prednitone
Promifen
Servisone
type: Drug
Study arms:
design_group_description: Patients receive abiraterone acetate PO QD, niclosamide PO BID and prednisone PO BID. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
design_group_title: Treatment (abiraterone acetate, niclosamide, prednisone)
design_group_type: Experimental
Sponsor: University of California, Davis
Collaborators: National Cancer Institute
Drug name mappings:
name: 泼尼松
lang: CN
name: Prednisone
lang: EN
name: 醋酸阿比特龙
lang: CN
name: Abiraterone acetate
lang: EN
name: アビラテロン酢酸エステル
lang: JP
name: 氯硝柳胺
lang: CN
name: Niclosamide
lang: EN