PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT06819878: A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
Official title: A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease
Conditions: Moderately to Severely Active Crohns Disease
Summary: This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Interventions:
description: Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
name: Afimkibart
other_name: PF-06480605
RG6631
RO7790121
RVT-3101
type: Drug
description: Placebo matching IV afimkibart. Placebo matching SC afimkibart.
name: Placebo
type: Drug
Study arms:
design_group_description: Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
design_group_title: Arm 1: Afimkibart
design_group_type: Experimental
design_group_description: Participants will receive afimkibart IV followed by afimkibart SC injection.
design_group_title: Arm 2: Afimkibart
design_group_type: Experimental
design_group_description: Participants will receive placebo IV followed by placebo SC.
design_group_title: Arm 3: Placebo
design_group_type: Placebo Comparator
Sponsor: Hoffmann-La Roche Ltd.
Collaborators: Chugai Pharmaceutical Co., Ltd.
Drug name mappings:
name: Afimkibart
lang: EN
Clinical trial NCT05985798: Sintilimab+Bevacizumab+TACE vs. Lenvatinib+TACE for Advanced HCC
Official title: Sintilimab, Bevacizumab Plus TACE Versus Lenvatinib Plus TACE for Advanced Stage Hepatocellular Carcinoma: A Randomized Controlled Trial
Conditions: Hepatocellular Carcinoma Non-resectable
Summary: This study is conducted to evaluate the efficacy and safety of sintilimab, bevacizumab plus TACE (Sin-Bev-TACE) compared with lenvatinib plus TACE (Len-TACE) for patients with advanced stage hepatocellular carcinoma (HCC).
Interventions:
description: Sintilimab (200mg I.V. q3w) and bevacizumab (7.5mg/kg I.V. q3w) are administered at 3-7 days after the first TACE. The study treatment of sintilimab and bevacizumab will last up to 24 months. TACE can be repeated on demand.
name: Sin-Bev-TACE
type: Drug
description: Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd will be started at 3-7 days after the first TACE. TACE will be repeated on demand.
name: Len-TACE
type: Drug
Study arms:
design_group_description: Sintilimab, bevacizumab plus TACE
design_group_title: Sin-Bev-TACE
design_group_type: Experimental
design_group_description: Lenvatinib plus TACE
design_group_title: Len-TACE
design_group_type: Active Comparator
Sponsor: Second Affiliated Hospital of Guangzhou Medical University
Collaborators: Affiliated Tumor Hospital of Guangzhou Medical University
Zhongshan People's Hospital
Drug name mappings:
name: 信迪利单抗
lang: CN
name: Sintilimab
lang: EN
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
Clinical trial NCT00021281: Combination Chemotherapy With or Without SU5416 in Treating Patients With Metastatic Colorectal Cancer
Official title: A Phase III, Randomized, Open-Label Multicenter, International Study Comparing The Combination Of SU5416/Irinotecan/5-Fluorouracil/Leucovorin Versus Irinotecan/Fluorouracil/Leucovorin Alone As First-Line Therapy Of Patient With Previously Untreated Metastatic Colorectal Cancer
Conditions: Colorectal Cancer
Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. SU5416 may stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known whether combination chemotherapy will be more effective with or without SU5416 in treating metastatic colorectal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without SU5416 in treating patients who have metastatic colorectal cancer.
Interventions:
name: FOLFIRI regimen
type: Drug
name: fluorouracil
type: Drug
name: irinotecan hydrochloride
type: Drug
name: leucovorin calcium
type: Drug
name: semaxanib
type: Drug
Study arms:
Sponsor: Jonsson Comprehensive Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 司马沙尼
lang: CN
name: Semaxanib
lang: EN
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: 盐酸伊立替康
lang: CN
name: Irinotecan Hydrochloride
lang: EN
name: イリノテカン塩酸塩水和物
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 NCT04861259: A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Official title: A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Adult and Adolescent Patients With Atypical Hemolytic Uremic Syndrome (aHUS)
Conditions: Atypical Hemolytic Uremic Syndrome
Summary: This study aims to evaluate the efficacy and safety of crovalimab in adult and adolescent participants with aHUS.
Interventions:
description: Crovalimab will be administered at a dose of 1000 milligrams (mg) intravenous (IV) (for participants with body weight at least 40 (>=) and up to 100 kilograms (kg) or 1500 mg IV (for participants with body weight >=100kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, it will be administered at a dose of 340 mg subcutaneously (SC). On Week 5 and every 4 weeks (Q4W) thereafter, it will be administered at a dose of 680 mg SC (for participants with body weight >= 40kg to <100kg) or 1020 mg SC (for participants with body weight >=100kg).
name: Crovalimab
type: Drug
Study arms:
design_group_description: Participants will be enrolled in three cohorts: [1] Naive Cohort - participants who have not been previously treated with complement inhibitor therapy; [2] Switch Cohort - participants who switch to crovalimab from another Complement Component 5 (C5) inhibitor and [3] C5 Single Nucleotide Polymorphism (C5 inhibitor) Cohort - participants with documented C5 polymorphism.
design_group_title: Crovalimab
design_group_type: Experimental
Sponsor: Hoffmann-La Roche, Inc.
Collaborators: Chugai Pharmaceutical Co., Ltd.
Drug name mappings:
name: 可伐利单抗
lang: CN
name: Crovalimab
lang: EN
name: クロバリマブ（遺伝子組換え）（JAN）
lang: JP
Clinical trial NCT01124929: Treatment Duration for Abdominal Tuberculosis
Official title: A Multi-centric Study on Treatment of Abdominal Tuberculosis (Intestinal or Peritoneal): A Randomized Controlled Trial to Compare the 6 Months of Cat I Treatment With 9 Months of Cat I Treatment (Extension for 3 Months) in Abdominal Tuberculosis Under the Revised National Tuberculosis Control Program
Conditions: Tuberculosis
Summary: Most of the guidelines on the treatment of tuberculosis suggest that 6 months treatment is sufficient for extrapulmonary tuberculosis except for bone tuberculosis and tubercular meningitis. Despite these recommendations, most physicians treating abdominal tuberculosis use antituberculous therapy for 9 months, sometimes even 12 months without any scientific justification. In a randomized controlled trial, Balasubramaniam et al reported no difference in success rate of 6mo (99%) vs 12 months (94%) antituberculous drugs (conventional strategy) in the treatment of abdominal tuberculosis.
Although Directly Observed Therapy (DOTs) have been proved to be effective in patients with pulmonary tuberculosis, lymph nodal tuberculosis, however, there is a lack of data on efficacy of DOTS in other extra-pulmonary disease including abdominal tuberculosis. Therefore, there is an urgent need to establish the efficacy of DOTs strategy of antituberculous therapy in the treatment of abdominal tuberculosis.
Therefore, the investigators planned to conduct a multicenter randomized controlled trial to determine the difference in the recurrence of disease after only observation for three months and three months extension of DOTs in a subset of patients with definite clinical response after 6 months of DOTs.
Interventions:
description: 2H3R3Z3 E3 + 4H3R3
name: RNTCP Category I treatment for 6 months
type: Drug
description: 2H3R3Z3 E3 + 7H3R3
name: RNTCP Category I treatment for 9months
type: Drug
Study arms:
design_group_description: Anti-tuberculosis drugs
design_group_title: Arm 1: Category I treatment for 6 months
design_group_type: Active Comparator
design_group_description: Anti-tuberculosis drugs,
design_group_title: Arm 2: Category I treatment for 9 months
design_group_type: Active Comparator
Sponsor: All India Institute of Medical Sciences
Collaborators: Sanjay Gandhi Post Graduate Institute of Medical Sciences
Christian Medical College & Hospital
Drug name mappings:
name: 乙胺吡嗪利福异烟
lang: CN
name: Ethambutol Hydrochloride/Isoniazid/Pyrazinamide/Rifampicin
lang: EN
Clinical trial NCT05736861: ACTIV-6: COVID-19 Study of Repurposed Medications - Arm A (Ivermectin 400)
Official title: ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications
Conditions: Covid19
Summary: The purpose of this study is to evaluate the effectiveness of repurposed medications (study drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19. Participants will receive either study drug or placebo. They will self-report any new or worsening symptoms or medical events they may experience while taking study drug or placebo. This study is intended to be all remote with no in person visits, unless the study team feels it is in the best interest of a participant to see them in person.
Prior and current drug arms are listed on clinicaltrials.gov and will be updated with the activation of any new drug arms. This protocol was originally registered under NCT04885530. Per recent guidance on reporting master protocol research programs (MPRPs), a separate record for Arm A was created.
Interventions:
description: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.
name: Ivermectin
other_name: Ivermectin Tablets
type: Drug
description: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
name: Placebo
type: Other
Study arms:
design_group_description: Ivermectin - 7-mg tablets<br/>Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg.
design_group_title: Arm A - Ivermectin 400
design_group_type: Experimental
design_group_description: Placebo - appearance and size matched to active study drug.<br/>Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing.
design_group_title: Arm A - Placebo
design_group_type: Placebo Comparator
Sponsor: Duke University
Collaborators: Vanderbilt University Medical Center
National Center for Advancing Translational Sciences
Drug name mappings:
name: 伊维菌素
lang: CN
name: Ivermectin
lang: EN
name: イベルメクチン
lang: JP
Clinical trial NCT02419664: Ga-68-DOTATOC -PET in the Management of Pituitary Tumours
Official title: Ga-68-DOTATOC -PET in the Management of Pituitary Tumours
Conditions: Pituitary Tumours
Summary: Title: Gallium (GA) -68-DOTATOC -PET (positron emission tomography) in the management of pituitary tumours Medical product: Ga-68-DOTATOC in PET/computer tomography (CT) Route of administration: Intravenously Diseases of interest: Pituitary tumours Aim: To study the detection of pituitary tumours with Ga-68-DOTATOC -PET (Ga-PET) and to correlate the tracer expression to somatostatin receptor (sst) occurrence Study design: Prospective non-randomised case-control study with open design with GA-PET before and after pituitary surgery in patients with pituitary tumours Study population: patients with acromegaly (n=10), Cushing's' disease of pituitary origin (n=10), TSH (thyreotropin) producing tumours (TSHomas) (n=5) and non-functioning pituitary adenomas (NFPA) (n=20) Number of patients: 45 Inclusion criteria: Adult man or woman (over 18 years) and naïve, unoperated pituitary tumour with growth hormone (GH) or adrenocorticotrophic hormone (ACTH)) or TSH production or NFPA without treatment with somatostatin analogues (SSA) or dopamine agonists.
Exclusion criteria: Patient who may not attend to the protocol according to the investigators opinion. Pregnancy or lactating. Isolated prolactin producing tumours. Overproduction of gonadotropins. Carcinoids ie ectopic corticotrophin realising factor (CRF) production. Known or suspected allergy to the trial product or related products.
Controls: Adult patients with Thyroid associated ophthalmopathy (TAO) before iv steroid infusion (part of another study see this protocol)- Study variables: Tumour detection, Tracer uptake as Standardised uptake value (SUV) max (SUVmax), SUV hotspot and SUV mean in regions of interests (ROIs) Time schedule: Recruitment of patients 2015-2017. Study termination 3 years later
Interventions:
description: The intervention is to administer Ga-68 DOTATOC in pituitary patients doing PET/CT
name: Gallium-68 DOTATOC PET
other_name: Ga-PET
type: Drug
Study arms:
design_group_description: To give Ga-68 DOTATOC in pituitary patients doing PET/CT<br/>They are compared with Ga-68 DOTATOC PET performed in another study on patients with no pituitary disease.
design_group_title: Ga-68 DOTATOC PET in pituitary adenomas
design_group_type: Experimental
Sponsor: University of Gothenburg
Collaborators: Sahlgrenska Universitetssjukhuset
University of Uppsala
Drug name mappings:
name: 镓[68Ga]伊索曲肽
lang: CN
name: 68Ga-Edotreotide
lang: EN
Clinical trial NCT02385097: Chloroprocaine 2% vs Ropivacaine 0.75% in Ultrasound-guided Axillary Nerve Block
Official title: A Prospective, Randomised, Non-inferiority Study of Chloroprocaine 2% and the Active Control Ropivacaine 0.75% (AstraZeneca) in Ultrasound-guided Axillary Nerve Block for Short-duration Distal Upper Limb Surgery
Conditions: Axillary Nerve Block
Summary: The Study evaluate the non-inferiority of Test product (Chloroprocaine 2%) versus Reference product (Ropivacaine 0.75%) in terms of proportion of subjects with a successful block for distal upper limb surgeries Successful block: anaesthesia adequate for the surgery without any supplementation in the first 45 min.
Interventions:
description: Single Administration (20mL) by Axillary Nerve Route
name: Chloroprocaine HCl 2%
other_name: Ampres
type: Drug
description: Single Administration (20mL) by Axillary Nerve Route
name: Ropivacaine 0.75%
other_name: Naropin
type: Drug
Study arms:
design_group_description: Chloroprocaine 2 % Solution for injection, single administration by axillary nerve route 20 mL
design_group_title: Chloroprocaine HCl 2% (20 mg/mL)
design_group_type: Experimental
design_group_description: Ropivacaine 0.75% Solution for injection, single administration by axillary nerve route 20 mL
design_group_title: Ropivacaine 0.75% (7.5 mg/mL)
design_group_type: Active Comparator
Sponsor: Sintetica SA
Collaborators: Cross SA
Drug name mappings:
name: 盐酸氯普鲁卡因
lang: CN
name: Chloroprocaine Hydrochloride
lang: EN
Clinical trial NCT00441584: The Effects of PegIntron Plus Rebetol in Subjects With Chronic Hepatitis C Not Responding to Pegasys (Study P03833)
Official title: Efficacy and Safety of PEG-Intron Plus Rebetol in Subjects With Chronic Hepatitis C Genotype 1 Non Responder to Pegasys
Conditions: Hepatitis C, Chronic
Summary: This is an uncontrolled, non-randomized, open-label, multinational study designed to evaluate the efficacy and safety of PegIntron plus Rebetol in subjects with chronic hepatitis C. The study is designed to determine the proportion of chronic hepatitis C genotype 1 subjects who did not respond to previous treatment with Pegasys 180µg QW plus ribavirin, that will achieve sustained virological response (SVR) when treated with PegIntron plus Rebetol.
Interventions:
description: Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
name: PegIntron (peginterferon alfa-2b)
other_name: SCH 54031, PEG-Intron, PegIntron, ViraferonPeg, peginterferon alfa-2b
type: Biological
description: 200 mg capsules, oral, weight based dose of 800-1400 mg, daily for up to 48 weeks
name: Rebetol (ribavirin)
other_name: SCH 18908, Rebetol, REBETOL, ribavirin
type: Drug
Study arms:
design_group_description: PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
design_group_title: PegIntron plus Rebetol
design_group_type: Experimental
Sponsor: Merck Sharp & Dohme Corp.
Collaborators: Integrated Therapeutics Group, Inc.
Drug name mappings:
name: 聚乙二醇干扰素α-2b注射(Merck & Co)
lang: CN
name: Peginterferon alfa-2b(Merck & Co)
lang: EN
name: 利巴韦林
lang: CN
name: Ribavirin
lang: EN
name: リバビリン
lang: JP
Clinical trial NCT06258811: Neoadjuvant Immunochemotherapy for LAOSCC
Official title: Neoadjuvant Immunochemotherapy With Tislelizumab, Albumin Paclitaxel and Cisplatin Followed by Standard Therapy Versus Standard Therapy for Locally Advanced Oral Squamous Cell Carcinoma, a Multicenter Randomized Phase 3 Trial
Conditions: Oral Squamous Cell Carcinoma
Locally Advanced Head and Neck Carcinoma
Summary: To evaluate the prognostic efficacy of neoadjuvant immunochemotherapy with tislelizumab, albumin paclitaxel and cisplatin followed by radical surgery and adjuvant therapy compared with standard therapy for patients with locally advanced and resectable oral squamous cell carcinoma.
Interventions:
description: Neoadjuvant immunochemotherapy (2 cycles, and 21 days each cycle, 260mg/m2 albumin paclitaxel intravenously on day 1 and day 22, with 75mg/m2 of cisplatin and 200mg of tislelizumab) + radical surgery + adjuvant therapy (radiation/chemoradiation followed by 200mg of tislelizumab, every 3 weeks for one year)
name: albumin paclitaxel, cispatin, tislelizumab
type: Drug
Study arms:
design_group_description: Neoadjuvant immunochemotherapy (albumin paclitaxel+cisplatin+tislelizumab) + radical surgery + adjuvant therapy (radiation/chemoradiation + tislelizumab maitainance)
design_group_title: Experimental arm
design_group_type: Experimental
design_group_description: Standard therapy of radical surgery +adjuvant therapy (radiation/chemoradiation)
design_group_title: Control arm
design_group_type: No Intervention
Sponsor: Shanghai Huashan Hospital
Collaborators: Fujian Medical University
Central South University
Sun Yat-Sen University
Fudan University
Drug name mappings:
name: 替雷利珠单抗
lang: CN
name: Tislelizumab
lang: EN
name: チスレリズマブ（遺伝子組換え）（JAN）
lang: JP
Clinical trial NCT04192266: Estrogen and Fear in PTSD
Official title: A Randomized, Double-blind Placebo-controlled Multi-center Study of Identifying Neural Mechanisms of PTSD Symptom Reduction Induced by Combined Estrogen and Prolonged Exposure Therapy
Conditions: PTSD
Summary: The purpose of this research study is to determine if taking a pill of estradiol (E2) together with prolonged exposure (PE) therapy can improve this treatment outcome in women diagnosed with Post-Traumatic Stress Disorder (PTSD). 80 subjects will take part in this research study across UTHealth Houston and UPenn (40 subjects at each site). Participants will be randomized into one of two groups, PE + E2 or PE + placebo. The study will include preliminary screening and baseline visits, experimental visits, and therapy visits over the course of six weeks. Several follow-up visits will take place.
Interventions:
description: 2.0 mg of estradiol will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions (Session 2- 6)
name: Estradiol
other_name: Estrace
type: Drug
description: 2.0 mg placebo pills will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions ( Sessions 2-6)
name: Placebo oral tablet
type: Drug
description: There will be an introductory Prolonged Exposure (PE) therapy session, followed by 5 imaginal exposure sessions, such that there will be 2 sessions per week conducted for a total of 6 sessions over 3 weeks. The PE sessions are 60 minutes long and consist of imaginal exposure. Specifically, the patient is instructed to imagine the trauma and recount it aloud for about 25-30 minutes. In the following 15 minutes, the patient processes her reactions to revisiting the traumatic event by discussing related thoughts and feelings. The session ends with in vivo exposure homework to be completed that same day as the session. In the last session, imaginal exposure is conducted one last time for the same duration as previous sessions. The therapist and patient review treatment progress and discuss applications of treatment principles to daily life.
name: Prolonged Exposure (PE) therapy
type: Behavioral
Study arms:
design_group_description: A single 2mg dose of estradiol (a form of estrogen) will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
design_group_title: Prolonged Exposure (PE) therapy with Estradiol
design_group_type: Experimental
design_group_description: A single 2mg placebo pill will be taken at home by the study participant 5-6 hours before each of 5 prolonged exposure (PE) therapy treatment sessions (sessions 2 to 6). PE therapy is a validated treatment for PTSD.
design_group_title: Prolonged Exposure (PE) therapy with Placebo
design_group_type: Placebo Comparator
Sponsor: The University of Texas Health Science Center at Houston
Collaborators: National Institute of Mental Health
Drug name mappings:
name: 戊酸雌二醇
lang: CN
name: Estradiol Valerate
lang: EN
name: エストラジオール吉草酸エステル
lang: JP
Clinical trial NCT02060903: A Study of the Efficacy and Safety of Abametapir Lotion Administered for the Treatment of Head Lice Infestation
Official title: A Randomized, Double-Blind, Multicenter, Vehicle-Controlled Study of the Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation
Conditions: Head Lice Infestation
Summary: The purpose of the study was to assess the efficacy, safety and tolerability of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to the scalp and hair for 10 minutes at home.
Interventions:
description: Abametapir Lotion 0.74% was dispensed to subjects on Day 0 for self-administration at home on the same day.
name: Abametapir Lotion 0.74% w/w
other_name: Abametapir 0.74%
type: Drug
description: Vehicle Lotion was dispensed to subjects on Day 0 for self-administration at home on the same day.
name: Vehicle Lotion
other_name: Vehicle
type: Drug
Study arms:
design_group_description: Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver.
design_group_title: Abametapir Lotion 0.74% w/w
design_group_type: Active Comparator
design_group_description: Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver.
design_group_title: Vehicle Lotion
design_group_type: Placebo Comparator
Sponsor: Dr. Reddy's Laboratories Ltd. (Russia)
Collaborators: Accelovance, Inc.
Syneos Health, Inc.
Drug name mappings:
name: Abametapir
lang: EN