PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT04600167: Preventive Treatment Of Latent Tuberculosis Infection In People With Diabetes Mellitus
Official title: A Randomized Double Blind Placebo Controlled Trial of Rifapentine and Isoniazid for Prevention of Tuberculosis in People With Diabetes
Conditions: Diabetes Mellitus
Tuberculosis
Summary: Diabetes mellitus (DM) increases susceptibility to Tuberculosis (TB) and worsens TB patient outcomes. The number of patients with combined TB and DM now outnumbers that of combined TB and HIV and it has been estimated that 15-30% of TB disease may be attributable to diabetes globally. This may be expected to rise substantially as DM prevalence increases. Treatment of Latent TB Infection (LTBI) in this population will likely have a significant clinical benefit. Similar to HIV-infected individuals, those with DM might benefit from therapy to prevent the development of TB disease. Current international guidelines do not recommend LTBI management in people with DM, but this is because no studies have examined the risk-benefit ratio of such an intervention. To date, no RCTs have been conducted to investigate the efficacy and safety of preventive treatment of LTBI in DM patients. Based on evidence on effectiveness, safety, and treatment completion rates, 3HP has been selected as the regimen of choice for this study of African people living with DM. People living with DM will be randomized to 3HP or placebo to determine the efficacy of 3HP in the prevention of TB disease in this population. PROTID's preventive treatment of LTBI among people with DM will generate the first solid evidence to support or refute the use of preventive treatment against TB in people with DM.
Interventions:
description: Oral combination of rifapentine (RPT, 900 mg) and isoniazid (INH, 900 mg), once-weekly for 12 weeks.
name: Isoniazid and Rifapentine (INH-RPT)
other_name: 3HP
type: Drug
description: Participants in the control group will receive placebo once weekly for 12 weeks
name: Placebo
type: Drug
Study arms:
design_group_description: Participants in intervention arm will receive an oral combination of rifapentine (RPT, 900 mg) and isoniazid (INH, 900 mg), once-weekly for 12 weeks.
design_group_title: Isoniazid and Rifapentine (INH-RPT)
design_group_type: Experimental
design_group_description: Participants in the control arm will receive placebo once weekly for 12 weeks.
design_group_title: Control
design_group_type: Placebo Comparator
Sponsor: The National Institute For Medical Research
Collaborators: Makerere University
St. George's University of London
King's College London
Kilimanjaro Christian Medical College
University of Otago
Stichting Katholieke Universiteit- Radboudumc (RUMC), Netherlands
Drug name mappings:
name: 利福喷丁
lang: CN
name: Rifapentine
lang: EN
name: 异烟肼
lang: CN
name: Isoniazid
lang: EN
name: イソニアジド
lang: JP
Clinical trial NCT02268045: Study of RTXM83 Plus CHOP Chemotherapy Versus a Rituximab Plus CHOP Therapy in Patients With Non Hodgkin's Lymphoma
Official title: A Randomized, Double-blind, Phase III Study Comparing Biosimilar Rituximab (RTXM83) Plus CHOP Chemotherapy Versus a Reference Rituximab Plus CHOP (R-CHOP) in Patients With Diffuse Large B-cell Lymphoma (DLBCL) Given as First Line
Conditions: Diffuse Large B-cell Lymphoma
Summary: This is a multicenter, double-blind, randomized study comparing the efficacy, pharmacokinetics (PK)/pharmacodynamics (PD), safety and immunogenicity profile of RTXM83 (rituximab biosimilar) vs reference rituximab (MabThera®), both with CHOP, as first-line treatment of Diffuse-Large-B-Cell-Lymphoma (DLBCL).
Rituximab biosimilar and MabThera® were both administered intravenously on Day 1 of each 3-week cycle with CHOP chemotherapy for six cycles. Two additional cycles of treatment were permitted at the Investigator's discretion. Patients were followed up for 9 months after last study dose.
Interventions:
description: Rituximab biosimilar (RTXM83) will be administered in combination with CHOP chemotherapy regimen (Cyclophosphamide 750 mg/m2, Doxorubicin 50 mg/m2 and Vincristine 1.4 mg/m2 up to a maximum of 2 mg on Day 1 plus Prednisone 40 mg/m2 or 100 mg per day from Day 1 to 5) at a dose of 375 mg/m2 on Day 1 of each 3 week cycle, for 6 cycles, although the administration of 2 additional cycles may be allowed.
name: RTXM83
other_name: Rituximab Biosimilar
type: Biological
description: Mabthera will be administered in combination with CHOP chemotherapy regimen (Cyclophosphamide 750 mg/m2, Doxorubicin 50 mg/m2 and Vincristine 1.4 mg/m2 up to a maximum of 2 mg on Day 1 plus Prednisone 40 mg/m2 or 100 mg per day from Day 1 to 5) at a dose of 375 mg/m2 on Day 1 of each 3 week cycle, for 6 cycles, although the administration of 2 additional cycles may be allowed.
name: Mabthera
other_name: Reference rituximab
type: Biological
Study arms:
design_group_description: Active Ingredient: Rituximab (Biosimilar)
design_group_title: RTXM83
design_group_type: Experimental
design_group_description: Active Ingredient: Rituximab
design_group_title: MabThera
design_group_type: Active Comparator
Sponsor: mAbxience Research SL
Collaborators: Key Oncologics (Pty) Ltd.
Tecnoquímicas SA
Libbs Farmacêutica Ltda.
Innogene Kalbiotech Pte Ltd.
Laboratorios de Productos Éticos C.E.I.S.A.
Laboratorio Elea Phoenix SA
NANOLEK LLC
Drug name mappings:
name: 利妥昔单抗生物类似药 (mAbxience)
lang: CN
name: Rituximab biosimilar (mAbxience)
lang: EN
Clinical trial NCT04338022: Study of Evobrutinib in Participants With RMS (evolutionRMS 1)
Official title: A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety (evolutionRMS 1)
Conditions: Relapsing Multiple Sclerosis
Summary: The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS). Participants who complete the double-blind treatment period (DBTP) and double-blind extension period (DBEP) prior to approval of a separate long-term follow-up study in their country will get an option for evobrutinib treatment continuation through a 96-week open-label extension (OLE) period.
Interventions:
description: Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period and followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in open label extension (OLE) period.
name: Teriflunomide
type: Drug
description: Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period and followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in open label extension (OLE) period.
name: Evobrutinib
other_name: M2951
type: Drug
Study arms:
design_group_title: Teriflunomide
design_group_type: Active Comparator
design_group_title: Evobrutinib
design_group_type: Experimental
Sponsor: Merck Healthcare KGaA
Collaborators: EMD Serono Research & Development Institute, Inc.
Drug name mappings:
name: 埃沃布鲁替尼
lang: CN
name: Evobrutinib
lang: EN
Clinical trial NCT00017277: Radiation Therapy With or Without Epoetin Alfa in Treating Patients With Head and Neck Cancer
Official title: A Phase III Double-Blind, Randomized, Placebo-Controlled Study of Erythropoietin When Used as an Adjuvant to Radiation Therapy in Patients With Head and Neck Squamous Cell Carcinoma
Conditions: Head and Neck Cancer
Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may help prevent or treat cancer-related anemia. It is not yet known whether radiation therapy is more effective with or without epoetin alfa in treating head and neck cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without epoetin alfa in treating patients who have head and neck cancer.
Interventions:
name: epoetin alfa
type: Biological
name: radiation therapy
type: Radiation
Study arms:
Sponsor: European Organisation for Research & Treatment of Cancer
Collaborators: Charité - Universitätsmedizin Berlin
Drug name mappings:
name: 促红素α
lang: CN
name: Epoetin Alfa
lang: EN
name: エポエチン アルファ（遺伝子組換え）
lang: JP
Clinical trial NCT00826644: Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient
Official title: A Randomized Prospective Multicenter Trial of Belotecan/Cisplatin Versus Etoposide/Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer
Conditions: Carcinoma, Small Cell
Summary: Belotecan (Camtobell, CKD-602, Chong Kun Dang Pharm., Korea) is a new camptothecin derivative, that exhibits anticancer effects by inhibiting topoisomerase I. The investigators will have a randomized prospective multicenter trial of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer.
Primary endpoints
* to assess Response Rate
Secondary endpoints
* to assess Overall response duration, Time to progression, Overall survival
Interventions:
description: Belotecan : 0.5mg/㎡/day for Day 1 to 4, repeated every 3 weeks
name: Belotecan
other_name: Camtobell
type: Drug
description: Etoposide 100mg/㎡/day for Day 1 to 3, repeated every 3 weeks
name: Etoposide
type: Drug
description: Cisplatin 60mg/㎡/day for Day 1, repeated every 3 weeks
name: Cisplatin
type: Drug
Study arms:
design_group_title: Belotecan plus Cisplatin
design_group_type: Experimental
design_group_title: Etoposide plus Cisplatin
design_group_type: Active Comparator
Sponsor: Chonnam National University Hospital
Collaborators: Chong Kun Dang Pharmaceutical Corp.
Drug name mappings:
name: 顺铂
lang: CN
name: Cisplatin
lang: EN
name: シスプラチン
lang: JP
name: 盐酸贝洛替康
lang: CN
name: Belotecan Hydrochloride
lang: EN
Clinical trial NCT04194216: Antibiotic Prophylaxis in Rhinoplasty
Official title: Comparison of Outcomes in Rhinoplasty With the Use of Intraoperative Versus Postoperative Antibiotics
Conditions: Nasal Obstruction
Nasal Surgical Procedures
Summary: This study compares the efficacy of a single intra-operative (intravenous) dose of "cephalexin" (first generation cephalosporin) or "clindamycin" (lincosamides), alone versus both intra-operative (intravenous) dose of "cephalexin" (first generation cephalosporin) or "clindamycin" (lincosamides) and postoperative oral dose of "cephalexin" or "clindamycin" use in nasal surgery.
Interventions:
description: Treatment Arm A
name: Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg.
other_name: cleocin (clindamycin)
kelfex (cephalexin)
type: Drug
description: Treatment Arm B
name: Intra-operative single dose (iv) of "cephalexin" 2 g or "clindamycin" 900 mg and postoperative oral dose of "cephalexin" 250mg (every 4 hours) or "clindamycin" 150mg(every 6 hours) for 3 days
other_name: cleocin (clindamycin)
kelfex (cephalexin)
type: Drug
Study arms:
design_group_description: Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg.
design_group_title: Treatment arm A
design_group_type: Active Comparator
design_group_description: Intra-operative single intravenous(iv) dose of "cephalexin" 2 g or "clindamycin" 900 mg and postoperative oral dose of "cephalexin" 250mg every 4 hours or "clindamycin" 150mg every 6 hours, for a duration of three days.
design_group_title: Treatment arm B
design_group_type: Active Comparator
Sponsor: Stanford University
Collaborators: Loma Linda University
Washington University School of Medicine
University of Kansas
Vanderbilt University School of Medicine
Harvard University
University of Washington
Duke University
Drug name mappings:
name: 头孢氨苄
lang: CN
name: Cephalexin
lang: EN
name: セファレキシン
lang: JP
name: 盐酸克林霉素
lang: CN
name: Clindamycin Hydrochloride
lang: EN
name: クリンダマイシン塩酸塩
lang: JP
Clinical trial NCT00190632: To Evaluate the Safety in Patients Taking Duloxetine for Stress Urinary Incontinence
Official title: Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence
Conditions: Stress Urinary Incontinence
Summary: This is an on-going study to evaluate the long-term safety and maintenance of effect of duloxetine in patients suffering with stress urinary incontinence.
Interventions:
name: Duloxetine
type: Drug
Study arms:
Sponsor: Eli Lilly & Co.
Collaborators: Boehringer Ingelheim GmbH
Drug name mappings:
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
Clinical trial NCT00861276: Nicotine Substitute Prescribed at Hourly Intake or ad Libitum for Heavy Smokers Willing to Quit
Official title: Use of Nicotine Substitute Prescribed at Hourly Intake or ad Libitum for Heavy Smokers Willing to Quit: a Randomized Controlled Trial
Conditions: Smoking Cessation
Summary: Objective: To assess the impact of instructional guidance in the regular use of use nicotine nasal spray (NNS) on the true use of NNS during the first three weeks of smoking cessation for heavy smokers who are willing to quit.
Methods: This randomized, open, controlled trial included 50 patients who were heavy smokers, were willing to quit, and attending an academic outpatient clinic in Western Switzerland. Patients were randomised to instruction on NNS use as "ad libitum" (administration whenever cravings appear; control group) or to use NNS at least every hour when awake (intervention group). Intakes were monitored using an electronic device fixed in the spray unit (MDILogTM) during the first three weeks of use. Self reported abstinence from smoking at six months was confirmed by expired-air carbon monoxide. Using intention-to-treat analysis, random-effect GLS regression was used to calculate the mean difference of daily doses between groups controlling for lack of independence between measures from the same individual.
Interventions:
description: During the first month, subjects in the intervention group received instruction from the physician to use NNS regularly (at least 2 puffs/hour, for an average of 1 mg nicotine/hour when awake).
name: Nasal Spray Nicotine Substitute (Experimental)
other_name: Nicorette(R) nasal spray
type: Drug
description: In the control group, participants were instructed to use NNS as needed to suppress withdrawal symptoms when cravings appeared.
name: Nasal Spray Nicotine Substitute (ad libitum)
other_name: Nicorette(R) Nasal Spray
type: Drug
Study arms:
design_group_description: Arm instructed to use spray at least once an hour when awake.
design_group_title: 1
design_group_type: Experimental
design_group_description: Ad libitum: patients were instructed to use NNS when craving appears.
design_group_title: 2
design_group_type: Active Comparator
Sponsor: University of Lausanne
Collaborators: Pharmacia Corp.
Drug name mappings:
name: 尼古丁
lang: CN
name: Nicotine
lang: EN
Clinical trial NCT01922115: The Effect of Anticholinergics on Cognitive Function in the Elderly
Official title: The Effect of Anticholinergics on Cognitive Function in the Elderly: a Randomized Controlled Trial
Conditions: Mental Competency
Urinary Bladder, Overactive
Cognitive Function
Summary: Anticholinergic medication is used to treat overactive bladder (OAB). A known side effect of this medication is cognitive dysfunction. OAB is more prevalent in the elderly population - a group that also has a higher baseline risk of cognitive dysfunction. Our objective is to evaluate the effect of an anticholinergic medication on cognitive function in elderly women.
Interventions:
description: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit.
name: Trospium Chloride
other_name: Sanctura XR
type: Drug
name: Placebo
type: Drug
Study arms:
design_group_description: Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).
design_group_title: TROSPIUM CHLORIDE
design_group_type: Active Comparator
design_group_description: Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).
design_group_title: PLACEBO
design_group_type: Placebo Comparator
Sponsor: The University of North Carolina at Chapel Hill
Collaborators: American Urogynecologic Society
Drug name mappings:
name: 曲司氯铵
lang: CN
name: Trospium Chloride
lang: EN
Clinical trial NCT00314613: Functional Brain Imaging and Employment in First-Episode Psychotic Patients Treated With Risperdal
Official title: Functional Brain Imaging and Employment in First-Episode Psychotic Patients Treated With Risperdal
Conditions: Schizophrenia
Summary: Assured treatment with Risperal CONSTA will provide first-episode patients, who have a greater potential for therapeutic response, with their best opportunity for continued improvement in cognitive function beyond three months of treatment.
Interventions:
name: Antipsychotic/Risperidone Consta
type: Drug
Study arms:
Sponsor: Duke University
Collaborators: Janssen LP
Drug name mappings:
name: 利培酮
lang: CN
name: Risperidone
lang: EN
name: リスペリドン
lang: JP
Clinical trial NCT03460041: Caudal Dexmetedomedine Versus Magnesium in Orthopedic Pediatric Surgeries
Official title: Caudal Dexmetedomedine Versus Magnesium in Orthopedic Pediatric Surgeries
Conditions: Pain in Pediatric Patients
Summary: This study will be performed in Abo Elreesh Pediatric Hospital / Cairo University after obtaining approval by the University Ethics Committee, and a written informed consent from the parents or guardians.
Thirty six patients will be randomly assigned using an online randomization program (http://www.randomizer.org) and the sealed envelope method into three groups: Group D (n=12): Dexmetedomidine group. 0.5 ml of dexmetedomidine (2 μg/kg) added to bupivacaine, Group M (n=12) : Magnesium group.0.5 ml of magnesium sulphate (50 mg) added to bupivacaine, Group C (n=12) :Control group.bupivacaine 0.25% diluted in normal saline with total volume of 1 ml/kg.
Interventions:
description: caudal magnesium sulphate added to bupivacaine for pain management
name: Magnesium Sulfate
type: Drug
description: Caudal dexmetedomedine added to bupivacaine for pain management
name: Dexmetedomedine
type: Drug
description: Caudal bupivacaine for pain management
name: Bupivacaine
type: Drug
Study arms:
design_group_title: Control
design_group_type: Placebo Comparator
design_group_title: Magnesium
design_group_type: Active Comparator
design_group_title: Dexmetedomedine
design_group_type: Active Comparator
Sponsor: Cairo University
Collaborators: Cairo University
Drug name mappings:
name: 盐酸右美托咪定
lang: CN
name: Dexmedetomidine Hydrochloride
lang: EN
name: デクスメデトミジン塩酸塩
lang: JP
name: 硫酸镁
lang: CN
name: Magnesium Sulfate
lang: EN
name: 硫酸マグネシウム水和物
lang: JP
Clinical trial NCT00638508: ON-Q Pump Infusion of Ketorolac and Ropivacaine at the Wound Site for Postoperative Pain Management
Official title: The Analgesic Efficacy of Continuous Infusion of Ketorolac and Ropivacaine at the Wound Site Using ON-Q Pump for Postoperative Pain Management
Conditions: Postoperative Pain
Summary: After surgery it is normal to experience some pain at the site of operation. In order to reduce the pain, medication such as Morphine is injected into a vein using a Patient Controlled Analgesia (PCA) pump that is kept at bed side, and is activated by the patient when needed. However, Morphine is an opioid drug, which can cause side effects such as sedation, nausea, vomiting, and reduced breathing on prolonged use. In addition to the opioid drugs, local anesthetics, and other drugs called Non steroidal anti inflammatory drugs (NSAIDs) have been injected locally to provide prolonged pain relief without the side effects of morphine. Recently a portable device called ON-Q pump has been developed to continuously infuse the local anesthetic through 2 small catheters inserted at the wound site. The ON-Q Pump is a small tennis ball sized unit made of a soft synthetic material that slowly infuses the drug through the catheters by elastic force. This pump is very safe and is attached to a bedside pole or the patient's hospital gown. This pump has already been approved by the FDA for clinical use, and has been reported to provide effective pain management after some surgical procedures.
The primary aim of the present study is to evaluate the relative efficacy of the drugs Ketorolac and Ropivacaine infused through the ON-Q pump in reducing the pain following gynecologic surgery. Ketorolac and Ropivacaine are approved drugs that are frequently used for post operative pain relief. Our hypothesis is that these two drugs in combination will provide better analgesia than Ketorolac alone.
Interventions:
description: Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
name: Ketorolac
other_name: Toradol
type: Drug
description: Patients will receive Ketorolac at 5 mg/hr plus 0.5% Ropivacaine
name: Ketorolac and Ropivacaine
other_name: Toradol and Naropin
type: Drug
Study arms:
design_group_description: Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
design_group_title: Ketorolac
design_group_type: Active Comparator
design_group_description: Patients will receive Ketorolac 5 mg and Ropivacaine 0.5% (Group 2) via an infusion catheter at the incision site
design_group_title: Ketorolac with Ropivacaine
design_group_type: Experimental
Sponsor: Maimonides Medical Center
Collaborators: I-Flow Corp.
Drug name mappings:
name: 盐酸罗哌卡因
lang: CN
name: Ropivacaine Hydrochloride
lang: EN
name: ロピバカイン塩酸塩水和物
lang: JP
name: 酮咯酸氨丁三醇
lang: CN
name: Ketorolac Tromethamine
lang: EN
Clinical trial NCT01975051: A Study to Explore Association of Treatment Regimens for Visceral Leishmaniasis, Host Immunological, Genetical and Nutrition Factors With Post-kala-azar Dermal Leishmaniasis (PKDL)
Official title: A Study to Explore Association of Treatment Regimens for Visceral Leishmaniasis, Host Immunological, Genetical and Nutrition Factors With Post-kala-azar Dermal Leishmaniasis (PKDL)
Conditions: Post-kala-azar Dermal Leishmaniasis
Summary: We hypothesize that PKDL develop after SSG as well as after Miltefosine mono-therapy for VL; anti-inflammatory cytokines such as IL-10, TGF-β, serum lipids play key role for its pathogenesis & PKDL patients are genetically predisposed; diagnostic tool based on immunofluorescence technique will be more sensitive than slit skin examination for diagnosis of PKDL.
Interventions:
description: Tablet Miltefosine 100 mg in two devided doses for 12 weeks
name: Mitefosine
other_name: Brand name: Impavido
type: Drug
Study arms:
design_group_description: Tablet Miltefosine 100 mg daily in two divided doses for 12 weeks.
design_group_title: Miltefosine
design_group_type: Experimental
Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators: University of Nagasaki
Drug name mappings:
name: 米替福新
lang: CN
name: Miltefosine
lang: EN