PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT05021731: Short-course Rifamycin-based Regimens for Latent Tuberculosis in Patients With End-stage Kidney Disease
Official title: Comparison of 3-month Once-weekly Isoniazid Plus Rifapentine, 4-month Daily Rifampicin, and 3-month Daily Isoniazid Plus Rifampicin for the Treatment Latent Tuberculosis in Patients With End-stage Kidney Disease: A Randomised Clinical Trial
Conditions: Latent Tuberculosis
Kidney Failure
Summary: Objective To determine if treatment completion with a 4-month rifampin (4R) or 3-month rifapentine (P) + isoniazid (H) weekly for 12 weeks (3HP) regimens is better than with a 3-month (3HR) regimen for treatment of latent tuberculosis (TB) infection (LTBI) in patients with end stage kidney disease.
Methods Design: Multicenter, prospective, parallel-group, open-label, controlled clinical trial.
Study population: All adult patients with ESKD in who treatment for LTBI is prescribed at 7 hospitals.
Interventions: Patients who accept participation, will be randomly assigned to one of the 3 arms: 3HR (control) (90 doses), 4R (120 doses) or 3HP (12 doses).
Outcome: Proportion of participants who discontinue permanently the assigned treatment. Follow-up: Periodic assessment for permanent or temporary discontinuation, and adverse events of the assigned treatment.
Sample size: 225 subjects (75 per arm) will be needed to demonstrate, if exists, a 0.16 decrease in permanent discontinuation rates in the experimental arms (4R and 3HP) with respect to the control arm (3HR), with α= 0.025, β= 0.20, and 5% expected losses, and assuming a 0.25 proportion of permanent discontinuation in the control.
Interventions:
description: Administration of rifampicin plus isoniazid for latent tuberculosis
name: Rifampicin plus Isoniazid
type: Drug
description: Administration of rifapentine plus isoniazid for latent tuberculosis
name: Rifapentine plus Isoniazid
type: Drug
description: Administration of rifampicin alone for latent tuberculosis
name: Rifampicin alone
type: Drug
Study arms:
design_group_description: Daily isoniazid 300 mg plus rifampicin 600 mg for three months
design_group_title: 3-month Isoniazid plus Rifampicin
design_group_type: Active Comparator
design_group_description: Weekly isoniazid 900 mg plus rifapentine 900 mg for 12 weeks
design_group_title: 3-month Isoniazid plus Rifapentine
design_group_type: Experimental
design_group_description: Daily rifampicin 600 mg for four months
design_group_title: 4-month Rifampicin
design_group_type: Experimental
Sponsor: Bellvitge University Hospital
Collaborators: Institut d'Investigació Biomèdica de Bellvitge
Instituto De SAlud Carlos Iii De Madrid
Drug name mappings:
name: 利福喷丁
lang: CN
name: Rifapentine
lang: EN
name: 利福平
lang: CN
name: Rifampin
lang: EN
name: リファンピシン
lang: JP
name: 异烟肼
lang: CN
name: Isoniazid
lang: EN
name: イソニアジド
lang: JP
Clinical trial NCT05311930: Efficacy and Safety of TPO Receptor Agonists in the Treatment of Elderly ITP Patients
Official title: Efficacy and Safety of TPO Receptor Agonists as First-line Drugs in the Treatment of Newly Diagnosed Elderly ITP Patients in China-an Open Label Study
Conditions: Primary Immune Thrombocytopenia
Summary: Elderly ITP patients have many underlying diseases, hormone contraindications and many adverse reactions during the use of hormones. TPO-RAs are oral small-molecule non-peptide drugs. Retrospective studies have shown that they have good efficacy and high safety in elderly patients. Therefore, this study is a prospective trial to evaluate TPO-RAs as the first-choice drug for the treatment of elderly ITP patients with contraindications to hormones, aiming to improve the efficacy-risk ratio of elderly patients
Interventions:
description: After the subjects signed the informed consent and passed the screening, they entered the treatment period and received a starting dose of 2.5 mg/d of Hytrombopag. During the treatment process, the clinician adjusted the drug dose according to the patient's own conditions. The maximum drug dose was 7.5 mg qd, 28 d Evaluate efficacy and safety after completion;
name: 2.5mg/d Hetrombopag
other_name: no use
type: Drug
Study arms:
design_group_description: After the subjects signed the informed consent and passed the screening, they entered the treatment period and received a starting dose of 2.5 mg/d of Hetrabopag. During the treatment process, the clinician adjusted the drug dose according to the patient's own conditions. The maximum drug dose was 7.5 mg qd, 28 d Evaluate efficacy and safety after completion;
design_group_title: 2.5mg/d
design_group_type: Experimental
Sponsor: Wuhan Xiehe Hospital Tower
Collaborators: Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Drug name mappings:
name: 海曲泊帕乙醇胺
lang: CN
name: Herombopag Olamine
lang: EN
Clinical trial NCT07078786: Effect of Pre-delivery Dexamethasone in Comparison With Betamethasone on Fetal Heart Trace
Official title: Comparison of Effect of Antenatal Dexamethasone Versus Betamethasone on Antepartum Cardiactocography
Conditions: Cardiotocography
Steroids
Summary: As baby grows inside the womb of mother, heart and other organs develop. The heart activity can be recorded by placing a transducer on the belly of mother. The tracing obtain provides information about heart rate, any increase or decrease in heart rate and how much it varies with time. Variation in heart rate along with increase is indicator of fetal well being. Some mothers are at high risk of pre-term birth that is baby delivery before 37 weeks of gestation. In such cases steroids are given to mother to accelerate lung development of the baby so that it can easily adapt to outside world. Dexamethasone and Betamethasone are commonly used steroids which can also effect fetal heart activity.
Interventions:
description: Intramuscular injection of Betamethasone 12mg will be administered on 2 consecutive days
name: Betamethason Sodium Phosphate
type: Drug
description: two doses of 12mg of IM Dexamethasone given 24 hours apart
name: Dexamethasone
type: Drug
Study arms:
design_group_description: Intramuscular injection of Betamethasone 12mg will be administered on 2 consecutive days
design_group_title: Group Betamethasone
design_group_type: Experimental
design_group_description: 24mg of Dexamethasone in two divided doses will be given Intramuscularly over 24 hours apart
design_group_title: Group Dexmaethasone
design_group_type: Active Comparator
Sponsor: Rawalpindi Medical College
Collaborators: Rawalpindi Medical College
Drug name mappings:
name: 磷酸钠倍他米松
lang: CN
name: Betamethasone Sodium Phosphate
lang: EN
name: ベタメタゾンリン酸エステルナトリウム
lang: JP
Clinical trial NCT01822418: Agomelatine Treatment of Depression in Schizophrenia (AGOPSYCH)
Official title: Agomelatine Treatment of Major Depressive Episodes in the Course of Schizophrenic Psychoses (AGOPSYCH)
Conditions: Schizophrenia
Schizoaffective Disorder
Delusional Disorder
Summary: Major depressive episodes (MDEs) occur frequently during the course of psychotic disorders, and several antidepressive agents have been successfully applied. The new melatonergic antidepressant agomelatine (AGO) appears promising for the treatment of MDEs in schizophrenia for several reasons. The investigators plan to test the efficacy and tolerability of AGO for antidepressive treatment in schizophrenia. For this task, the investigators plan to enrol 27 schizophrenic patients into an open, single-armed, prospective clinical trial with agomelatine.
Interventions:
description: Augmentation of antipsychotic therapy with 25 to 50 mg agomelatine as a single oral dosage per day
name: agomelatine
other_name: Valdoxan
type: Drug
Study arms:
design_group_description: Open-label treatment with agomelatine 25 mg/day (or 50 mg/day after week 3).
design_group_title: Treatment
design_group_type: Experimental
Sponsor: Zentralinstitut für Seelische Gesundheit
Collaborators: Servier Pharmaceuticals LLC
Drug name mappings:
name: 阿戈美拉汀
lang: CN
name: Agomelatine
lang: EN
Clinical trial NCT07036991: Clinical Trial of PCSK9 Inhibitor and Statin Treatment for Carotid Artery Stenosis
Official title: A Randomized Clinical TRial on Inhibitor of PCSK9 and Statin Treatment for Carotid Artery Stenosis (TRIP-CAS)
Conditions: Carotid Artery Stenosis
Summary: A prospective, multicenter, randomized controlled, open-label, blinded outcome evaluation (PROBE) trial.
Interventions:
description: PCSK9 inhibitor (biweekly injections) + rosuvastatin/atorvastatin ± ezetimibe
name: Evolocumab (biweekly injections) + Rosuvastatin/Atorvastatin ± Ezetimibe
type: Drug
description: Rosuvastatin/atorvastatin ± ezetimibe
name: Rosuvastatin/Atorvastatin ± Ezetimibe
type: Drug
Study arms:
design_group_description: PCSK9 inhibitor (biweekly injections) + rosuvastatin/atorvastatin ± ezetimibe, initiated on randomization day
design_group_title: PCSK9 Inhibitor + Statin ± Ezetimibe Group
design_group_type: Experimental
design_group_description: Rosuvastatin/atorvastatin ± ezetimibe, continued or initiated on randomization day
design_group_title: Statin ± Ezetimibe Group
design_group_type: Active Comparator
Sponsor: Changhai Hospital of Shanghai
Collaborators: The First Affiliated Hospital of Soochow University
Drug name mappings:
name: 阿托伐他汀钙
lang: CN
name: Atorvastatin Calcium
lang: EN
name: アトルバスタチンカルシウム水和物
lang: JP
name: 瑞舒伐他汀钙
lang: CN
name: Rosuvastatin Calcium
lang: EN
name: ロスバスタチンカルシウム
lang: JP
name: 依洛尤单抗
lang: CN
name: Evolocumab
lang: EN
name: エボロクマブ（遺伝子組換え）
lang: JP
name: 依折麦布
lang: CN
name: Ezetimibe
lang: EN
name: エゼチミブ
lang: JP
Clinical trial NCT00625339: Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable HBV DNA
Official title: Randomized, Open-Labeled Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Continuing Lamivudine Therapy or Switching to Entecavir in Subjects With Chronic Hepatitis B Who Achieved Undetectable HBV DNA
Conditions: Hepatitis B, Chronic
Summary: This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 0.5mg QD from lamivudine versus maintaining lamivudine 100mg QD treatment in CHB patients currently receiving lamivudine monotherapy.
Interventions:
description: entecavir 0.5 mg QD
name: Entecavir
other_name: Baraclude 0.5mg
type: Drug
description: lamivudine 100 mg QD
name: Lamivudine
other_name: Zeffix 100mg QD
type: Drug
Study arms:
design_group_description: entecavir 0.5 mg QD
design_group_title: A
design_group_type: Experimental
design_group_description: lamivudine 100 mg QD
design_group_title: B
design_group_type: Active Comparator
Sponsor: Yonsei University
Collaborators: Pusan National University Hospital
Drug name mappings:
name: 恩替卡韦
lang: CN
name: Entecavir
lang: EN
name: エンテカビル水和物
lang: JP
Clinical trial NCT02498977: Liver Immunosuppression Free Trial
Official title: Prospective Randomised Marker-based Trial to Assess the Clinical Utility and Safety of Biomarker-guided Immunosuppression Withdrawal in Liver Transplantation
Conditions: Transplantation, Liver
Summary: LIFT is prospective randomised marker-based trial to assess the clinical utility and safety of biomarker-guided immunosuppression withdrawal in liver transplantation. 'LIFT' aims to validate a biomarker test of operational tolerance to stratify liver transplant recipients before withdrawing immunosuppressive medication. Primary objective is clinical utility and risk/benefit ratio of employing a transcriptional test of tolerance to stratify liver recipients prior to immunosuppression withdrawal. Secondary objectives are: safety of biomarker-guided immunosuppression withdrawal; health-economic and quality of life impact of biomarker-guided immunosuppression withdrawal; improvement in drug-related co-morbidities; prevalence of tolerance over time; role of donor-specific anti-human leukocyte antigen (HLA) antibodies; identify mechanisms of liver allograft tolerance. It is a prospective, multi-centre, phase IV, biomarker-strategy design trial with a randomized control group in which adult liver transplant recipients will undergo immunosuppression withdrawal. The sample size is 148 patients.
Interventions:
description: Real time polymerase chain reaction (PCR) gene expression measurement
name: Biomarker
type: Genetic
description: Immunosuppression drugs as per protocol
name: Tacrolimus, cyclosporine and/or mycophenolic acid, mycophenolate mofetil or azathioprine
other_name: IS
type: Drug
Study arms:
design_group_description: All participants satisfying clinical criteria will be weaned off immunosuppression drugs irrespective of biomarker result.
design_group_title: Arm A (weaning)
design_group_type: Active Comparator
design_group_description: Participants with a positive biomarker will be weaned of immunosuppression drugs.
design_group_title: Arm B+ (weaning- positive biomarker)
design_group_type: Active Comparator
design_group_description: Participant with negative biomarker test result will be informed of the result and will remain on baseline maintenance immunosuppression drugs.
design_group_title: Arm B- (maintenance)
design_group_type: Active Comparator
Sponsor: King's College London
Collaborators: King's College Hospital NHS Foundation Trust
Drug name mappings:
name: 环孢素
lang: CN
name: Cyclosporine
lang: EN
name: シクロスポリン
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: 硫唑嘌呤
lang: CN
name: Azathioprine
lang: EN
name: アザチオプリン
lang: JP
name: 吗替麦考酚酯
lang: CN
name: Mycophenolate Mofetil
lang: EN
name: ミコフェノール酸 モフェチル
lang: JP
Clinical trial NCT06705764: Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA)
Official title: Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA): A Phase 4 Double-Blinded, Parallel-Group, Randomized Control Trial With an Open Label Extension
Conditions: Severe Asthma
Summary: Adults with severe asthma may have sudden worsening shortness of breath that results in their going to Emergency Department for urgent care. Emergency Room visits for asthma management across Alberta have been reviewed and it has been found that adults frequently need to return for repeated worsening. This is a large drain on health care resources as well as being very distressing for individuals with asthma. Occasionally this results in admission to hospital and rarely may lead to death. People are often treated with steroids to try to prevent the need for Emergency Room visits even though steroid medications have many long term bad side effects.
A new medication for patients considered to have severe asthma has been recently approved by Health Canada. This medication, Tezepelumab, is a monthly injection and it helps control asthma in adults regardless of the underlying cause. The study will examine if starting Tezepelumab, compared with a placebo, in the Emergency Room will help settle symptoms of asthma and prevent future worsening requiring repeated Emergency Room visits or the need for courses of outpatient steroid medications.
Interventions:
description: Tezepelumab 210 mg (1.91 ml) subcutaneous every 4 weeks. Randomized Control Trial 90 days with Tezepelumab/ Matching Placebo dosing on Day 0, Day 30 and Day 60.<br/>Open-label extension study from Day 90 to Day 180 with Tezepelumab dosing at Day 90
name: Tezepelumab
type: Drug
description: Placebo 1.91 ml subcutaneous every 4 weeks. Randomized Control Trial 90 days with Tezepelumab/ Matching Placebo dosing on Day 0, Day 30 and Day 60.
name: Placebo
type: Drug
Study arms:
design_group_description: Tezepelumab 210 mg S/Q Q4W
design_group_title: Tezepelumab
design_group_type: Active Comparator
design_group_description: Matching Placebo S/Q Q4W
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: Open-label extension study from Day 90 to Day 180 with Tezepelumab dosing at Day 90
design_group_title: Tezepelumab Open Label
design_group_type: Other
Sponsor: University of Alberta
Collaborators: AstraZeneca PLC
Drug name mappings:
name: 特泽利尤单抗
lang: CN
name: Tezepelumab
lang: EN
name: テゼペルマブ (遺伝子組換え)
lang: JP
Clinical trial NCT04101890: The Healthy Baby Bottoms Study
Official title: The Healthy Baby Bottoms Study: A Trial of Theraworx Foam Formulation for the Prevention and Treatment of Diaper Dermatitis
Conditions: Diaper Dermatitis
Summary: Diaper dermatitis is one of the most common dermatologic diseases affecting infants and children. The incidence is highest among those 9-12 months old and it has been reported to affect 7-50% of infants in the US. It is caused by skin exposure to a combination of several factors including: excessive moisture, topical irritants, reduced pH, friction, maceration and bacterial infection. When infants soil their diaper, diaper contents saturate the area raising the pH of the skin above the normal level of 5 or less, and leaving the area highly vulnerable to maceration from friction. Irritants in urine and feces are then able to penetrate the macerated skin, causing inflammation and greater skin friability. An elevation in the skin pH allows pathogenic bacteria to overgrow, and combined with the breakdown in the skin's outer epithelial barrier, can lead to bacterial infection. Theraworx Foam Formulation-Allantoin Liquid by Avadim Technologies, Inc. is a skin protectant with use for temporary protection of minor cuts, scrapes, burns and chapped or cracked skin. As such, Theraworx Foam used in the diaper area may be beneficial for protecting skin against diaper rash wounds, as well as for assisting with wound healing and reducing any associated pain. The purpose of this study is to determine caregivers' perceptions of the benefits of using Theraworx Foam on their infant's diaper area as part of their hygienic routine, including whether they feel the product is pleasant and easy to use, and whether they feel it helps prevent and reduce the severity of diaper dermatitis in their infants 1-14 months old.
Interventions:
description: Theraworx foam formulation to be used as a preventive and treatment agent for diaper rashes
name: Diaper care with Theraworx
type: Drug
Study arms:
design_group_description: Participants will be given a 4 week supply of Theraworx Spray Foam, an FDA-registered OTC drug (NDC 61594-000), to apply a thin layer to their infant's entire diaper area with every diaper change (2-4 foam pumps or 4-6 sprays depending on the infant's size) for 4 weeks.
design_group_title: Diaper care with Theraworx
design_group_type: Experimental
design_group_description: Participants continue their typical diaper care.
design_group_title: Routine diaper care
design_group_type: No Intervention
Sponsor: Children's National Research Institute
Collaborators: AH Liquidation, Inc.
Drug name mappings:
name: 尿囊素
lang: CN
name: Allantoin
lang: EN
Clinical trial NCT00018759: Treatment Effects on Platelet Calcium in Hypertensive and Depressed Patients
Official title: Treatment Effects on Platelet Calcium in Hypertensive and Depressed Patients
Conditions: Depression
Hypertension
Summary: This study aims to determine if treatment with an SSRI antidepressant medication, paroxetine, is associated with cellular calcium response to serotonin, platelet serotonin receptors, and improvement in mood in depressed patients with or without hypertension. It is hypothesized that platelets of hypertensive patients with depressive symptomatology with be hyper-responsive to serotonin. Additionally, treatment with an SSRI antidepressant is expected to produce a down-regulation of the serotonin receptor with an associated reduction in platelet cytosolic calcium response as well as improved mood.
Interventions:
name: paroxetine
type: Drug
name: ongoing psychological screening
type: Behavioral
Study arms:
Sponsor: US Department of Veterans Affairs (District of Columbia)
Collaborators: Smithkline Beecham Plc
Drug name mappings:
name: 盐酸帕罗西汀
lang: CN
name: Paroxetine Hydrochloride
lang: EN
name: パロキセチン塩酸塩水和物
lang: JP
Clinical trial NCT02232971: Treatment of Low Blood Sugar With Glucagon Among Patients With Type 1 Diabetes
Official title: Treatment of Hypoglycemia With Glucagon Among Patients With Type 1 Diabetes Mellitus
Conditions: Diabetes Mellitus, Type 1
Summary: Background: Patients with type 1 diabetes (T1D) need a lifelong supply of external insulin and are advised to aim for near-normalization of blood glucose levels through intensive insulin therapy. We propose a new approach for achieving treatment goals in T1D: the combined use of insulin and glucagon, i.e. dual-hormone treatment.Only recently the prospect of treating patients with soluble glucagon has arisen and thus studies of low dose glucagon treatment of mild hypoglycemia are needed to determine whether there is clinical rationale for dual-hormone treatment of T1D.
Aim: The purpose of this clinical study is to investigate the glycemic response to subcutaneous glucagon administration during mild hypoglycemia in T1D patients treated with insulin pump. Different glucagon doses are applied to determine the most appropriate dose for future dual-hormone treatment of T1D.
Methods: A clinical, randomized, single blinded, crossover study will be conducted. Eight T1D patients treated with insulin pump are studied on four days. All patients are in good metabolic control (HbA1c < 7.5%), C-peptide negative and with hypoglycemia awareness. On each study day, hypoglycemia is induced with subcutaneously insulin and afterward treated with a single subcutaneous dose of glucagon. The study procedures are identical on all days except from the administered dose of glucagon (day 1: placebo, day 2: 100 ug, day 3: 200 ug, day 4: 300 ug). All patients are blinded for the glucagon dose and carry out the four days in random order.
Endpoints: The present study focuses primarily on the dose related plasma glucose response of glucagon; secondary on the duration of the hyperglycemic effect of glucagon and tertiary the glucagon effect on catecholamine, cortisol, growth hormone, free fatty acids and triglycerides.
The study will be conducted from august 2014.
Interventions:
description: Glucagon is given in three different doses according to three research days.
name: Glucagon
other_name: 2880 Bagsværd
Disp. no. 2514
GlucaGen (r)
Novo Allé
Novo Nordisk A/S
type: Drug
description: Placebo
name: Isotonic saline solution
other_name: 2100 København Ø
Amgros I/S
D.sp.no. 6733
Dampfærgevej 22
Natriumklorid isotonisk "SAD"
Postbox 2593
type: Other
Study arms:
design_group_description: Isotonic Saline
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: GlucaGen(r) 0.1 mg administration
design_group_title: Glucagon 0.1 mg
design_group_type: Experimental
design_group_description: GlucaGen(r) 0.2 mg administration
design_group_title: Glucagon 0.2 mg
design_group_type: Experimental
design_group_description: GlucaGen(r) 0.3 mg administration
design_group_title: Glucagon 0.3 mg
design_group_type: Experimental
Sponsor: Hvidovre University Hospital
Collaborators: Novo Nordisk Foundation
University of Copenhagen
Drug name mappings:
name: Glucagon(Xeris Pharmaceuticals, Inc.)
lang: EN