PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT00115726: Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure
Official title: Randomized Controlled Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure
Conditions: Hypertension
Hypotension
Edema
Congestive Heart Failure
Summary: The purpose of this study is to determine whether continuing or discontinuing furosemide (a diuretic) on the day of elective noncardiac surgery for those who take furosemide on a chronic basis, causes more intraoperative hypotension (low blood pressure) during surgery. Our hypothesis is that the usual practice of continuing furosemide on the day of surgery would contribute to more hypotension during surgery than discontinuing furosemide.
Interventions:
description: for patients on chronic furosemide therapy, patients are randomized to furosemide (at their previous dose) or placebo (given in identical form to ensure masking)
name: furosemide
type: Drug
description: patients will be given placebo capsules (identical to experimental arm in color) at the equivalent dose as to their chronic furosemide therapy.
name: placebo
type: Drug
Study arms:
design_group_description: furosemide
design_group_title: 1
design_group_type: Experimental
design_group_description: placebo
design_group_title: 2
design_group_type: Placebo Comparator
Sponsor: University of Calgary
Collaborators: The Center for the Advancement of Health IT
Drug name mappings:
name: 呋塞米
lang: CN
name: Furosemide
lang: EN
name: フロセミド
lang: JP
Clinical trial NCT00108368: The Effects of Risperidone and Olanzapine on Thinking
Official title: The Cognitive Effects of Risperidone and Olanzapine
Conditions: Schizophrenia
Psychotic Disorders
Summary: The goal of this research is to find ways to maximize the benefits of antipsychotic medications for cognition.
Hypothesis: Risperidone and olanzapine will show greater benefits than conventional medications on assessments of social cognition, particularly affect perception and social perception.
Interventions:
name: Risperidone
type: Drug
name: Olanzapine
type: Drug
Study arms:
Sponsor: US Department of Veterans Affairs (District of Columbia)
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
name: 奥氮平
lang: CN
name: Olanzapine
lang: EN
name: オランザピン
lang: JP
Clinical trial NCT04066088: Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi Syndrome
Official title: Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi Syndrome
Conditions: Prader-Willi Syndrome
Summary: This is a placebo-controlled clinical trial to assess the utility of Guanfacine Extended Release (GXR) in the management of patients with Prader Willi Syndrome (PWS) who have significant aggression or self-injury. The purpose of this trial is to establish the safety of GXR with a specific focus on metabolic effects.
Interventions:
description: Placebo will be administered same times as GXR
name: Placebo
type: Other
description: The starting dose for all subjects will be 1 mg per day. If the medication is well-tolerated, the dose can be raised to 2 mg until day 28 and increased to 3mg for the remaining 4 weeks in the trial. The dose schedule will not be fixed; the treating clinician can delay a planned increase or lower the dose to manage adverse effects. At week 8, the study will be unblinded and subjects will continue treatment for 8 more weeks.
name: Guanfacine extended release (GXR)
type: Drug
Study arms:
design_group_title: Placebo
design_group_type: Sham Comparator
design_group_description: Immediately following the 8-week blinded randomized trial, an 8-week open-label continuation phase will be pursued to further define efficacy and tolerability of GXR, and to establish its safety with specific focus on metabolic profile.
design_group_title: GXR
design_group_type: Experimental
Sponsor: NYU Langone Health
Collaborators: Winthrop-University Hospital, Inc.
Drug name mappings:
name: 盐酸胍法辛
lang: CN
name: Guanfacine hydrochloride
lang: EN
name: グアンファシン塩酸塩
lang: JP
Clinical trial NCT00538512: Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4
Official title: Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4
Conditions: Influenza
Summary: The purpose of this study is to evaluate the absolute (versus placebo) and relative (one vaccine compared to the other) efficacies of the live attenuated and inactivated influenza vaccines in preventing laboratory confirmed symptomatic influenza caused by circulating strains whether similar or dissimilar to strains included in the vaccines.
Interventions:
description: single dose licensed trivalent inactivated influenza vaccine (2007-08)
name: Fluzone
type: Biological
description: single dose licensed live-attenuated influenza vaccine Flumist (2007-08)
name: Flumist
type: Biological
description: single dose placebo administered as an intranasal spray or intramuscular injection
name: Physiologic saline
type: Other
Study arms:
design_group_description: the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
design_group_title: TIV
design_group_type: Active Comparator
design_group_description: live-attenuated influenza vaccine Flumist, manufactured by MedImmune
design_group_title: LAIV
design_group_type: Active Comparator
design_group_description: Physiologic saline administered as a nasal spray or intramuscular injection
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University of Michigan
Collaborators: Sanofi Pasteur SA
Drug name mappings:
name: 四价流感病毒裂解疫苗(Sanofi)
lang: CN
name: Tetravalent influenza vaccine(Split, inactivated)(Sanofi)
lang: EN
name: Influenza virus vaccine live intranasal (quadrivalent)(MedImmune LLC)
lang: EN
name: 経鼻弱毒生インフルエンザワクチン
lang: JP
Clinical trial NCT01015638: Compare the Tolerance of Clindamycin 1% /Benzoyl Peroxide (BPO) 5% Gel to Clindamycin 1.2%/ BPO 2.5% Topical Medications
Official title: Two-week Study to Determine and Compare the Tolerance and Irritation Potential of Duac® Topical Gel (Clindamycin 1% and Benzoyl Peroxide 5%) to ACANYA™ Gel (Clindamycin Phosphate 1.2% and Benzoyl Peroxide 2.5%) Topical Acne Medications
Conditions: Acne Vulgaris
Summary: This is a single-blind (blinded expert grader) study that will enroll 25-30 healthy volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide 5% or clindamycin phosphate and benzoyl peroxide 2.5% and the other side of the face will remain non-treated to serve as a control.
Interventions:
description: Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide (BPO) 5% gel.
name: Clindamycin and BPO 5% gel
other_name: Duac Topical Gel
type: Drug
description: Once daily application of clindamycin phosphate and benzoyl peroxide (BPO) 2.5% gel
name: Clindamycin phosphate and benzoyl peroxide 2.5% gel.
other_name: ACANYA Gel
type: Drug
Study arms:
design_group_description: Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide (BPO) 5% gel.
design_group_title: Clindamycin and BPO 5% gel
design_group_type: Experimental
design_group_description: Once Daily application of clindamycin phosphate and benzoyl peroxide (BPO) 2.5% gel.
design_group_title: Clindamycin phosphate and BPO 2.5% gel
design_group_type: Active Comparator
Sponsor: Stiefel Laboratories, Inc.
Collaborators: GSK Plc
Drug name mappings:
name: 克林霉素磷酸酯/过氧苯甲酰
lang: CN
name: Benzoyl Peroxide/Clindamycin Phosphate
lang: EN
name: クリンダマイシンリン酸エステル水和物/過酸化ベンゾイル
lang: JP
Clinical trial NCT00167557: Orthotopic Liver Transplant (OLT) Recipients With Hepatitis C Virus (HCV) Under Preemptive Treatment
Official title: Tacrolimus Monotherapy in OLT Recipients With HCV Under Preemptive Treatment With Interferon and Ribavirin
Conditions: Hepatitis C
Summary: After a liver transplant, the hepatitis C virus (which destroyed one's own liver) eventually comes back. In many patients, this will eventually cause the loss of the new liver and can also confuse the doctors taking care of them because it is hard to tell the difference between one's body rejecting the new liver and hepatitis. This can cause serious treatment errors that can lead to more severe hepatitis or to rejection of the liver. Some of the drugs used to prevent rejection of one's new liver can cause the hepatitis to come back in a more severe form. This is especially true for the drugs known as corticosteroids.
Right now, the only effective treatment against hepatitis C is a combination of two drugs called interferon and ribavirin. These drugs act by strengthening one's immune system to fight the virus and by directly reducing the reproduction of the virus. Because the treatment with these drugs is associated with many side effects, there is little experience with treating patients after liver transplantation with them.
In the investigators' transplant program, they have decided to treat all patients with hepatitis C as early as possible after transplantation and to follow them closely for the development of hepatitis and side effects of the treatment. The investigators treat one's hepatitis as early as possible, before any actual damage has occurred in the new liver. This approach has been tried before but it has been hard to tell if it has worked or not. The main reason for failure was that many patients could not complete the treatment due to side effects. The investigators' purpose is to treat those side effects aggressively so that most patients can complete the treatment course.
The purpose of this study is to collect all the data regarding the investigators' treatment protocol so that they will be able to learn if this form of treatment is beneficial.
The study includes performing liver biopsies at scheduled times after one's liver transplant and for scheduled blood tests to see how much virus is still in the blood. If patients show signs that they are not responding to treatment they will be removed from the study.
Interventions:
description: 180mcg SC weekly starting 30 days post transplant
name: Pegylated Interferon
type: Drug
description: goal dose 13mg/kg starting 120 days post transplant for a minimum of 48 wks
name: Ribavirin
type: Drug
description: Liver biopsies performed at 9 points in time from time of liver transplant
name: Liver Biopsy
type: Procedure
Study arms:
design_group_title: Single Arm Study
design_group_type: Experimental
Sponsor: The University of Texas Health Science Center at Houston
Collaborators: Astellas Pharma US, Inc.
Drug name mappings:
name: 利巴韦林
lang: CN
name: Ribavirin
lang: EN
name: リバビリン
lang: JP
Clinical trial NCT02281305: Post-MI PET Scan Imaging of Inflammation
Official title: Imaging of Inflammation in the Postischemic Myocardium: Effect of Anti-inflammatory Treatment With Colchicine
Conditions: Acute Myocardial Infarction
Summary: Restoring the patency of the coronary vessels and providing the ischemic myocardium with reperfused blood can cause additional tissue damage. A key element of ischemia and reperfusion (I/R) injury and major determinant of the evolution of damage in the affected myocardium is the inflammatory response. The main objective of the study is to evaluate the efficacy of colchicine in reducing I/R injury by effectively modulating the inflammatory response in the reperfused myocardium.
Interventions:
name: Colchicine
type: Drug
Study arms:
design_group_description: Drug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days
design_group_title: Colchicine Active treatment group
design_group_type: Experimental
design_group_description: Drug: Placebo
design_group_title: Control group
design_group_type: Placebo Comparator
Sponsor: General Hospital G. Gennimatas
Collaborators: Academy of Athens
Drug name mappings:
name: 秋水仙碱
lang: CN
name: Colchicine
lang: EN
name: コルヒチン
lang: JP
Clinical trial NCT00555087: Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate
Official title: Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate i.m. 1000 mg. A Prospective, Multi-Center Clinical Study Phase IV.
Conditions: Erectile Dysfunction
Hypogonadotrophic Males
Summary: The main objective of this study is to evaluate the response of erectile dysfunction in hypogonadotrophic males with Testosterone undecanoate i.m. as per IIEF and the question of the GAQ (Global Evaluation Questionnaire) after 42 weeks of treatment.
Secondary Study Objectives
* To monitor adverse events and changes in hemoglobin and serum chemistry with: PSA, lipid profile, renal-hepatic profile and glycemia, and control by means of a rectal digital examination.
* To Determinate physiologic reconstitution in patients under treatment by means of total and free testosterone dosage.
Interventions:
description: Testosterone Undecanoate 1000 mg IM injection; PDF5 tab, 20 mg
name: Testosterone Undecanoate and/or PDE-5
other_name: Levitra
Nebido
type: Drug
Study arms:
design_group_description: It is and intervention study with 1 arm
design_group_title: A= Nebido
design_group_type: Experimental
Sponsor: Hospital Santa Fe SA de CV
Collaborators: Bayer AG
Drug name mappings:
name: 十一酸睾酮
lang: CN
name: Testosterone Undecanoate
lang: EN
Clinical trial NCT05757167: Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Official title: Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity
Conditions: Malaria,Falciparum
Malaria in Pregnancy
Malaria in Childbirth
Pregnancy
Neonatal Health
Low Birthweight
Stillbirth
Gestational Age and Weight Conditions
Preterm Birth
Summary: The purpose of the INTREPiD study is to compare 1st trimester screening for malaria parasites with a high-sensitivity malaria rapid diagnostic test followed by treatment of test-positive women with artemether-lumefantrine (AL) against usual antenatal care on a composite adverse pregnancy outcome including low birth weight, small for gestational age, preterm, fetal loss, or neonatal death.
Interventions:
description: Detection of Plasmodium falciparum HRP-II antigen1<br/>Method: Lateral Flow; Time to Result: 20 minutes; Sample Type: Fingerstick Whole Blood; Sample Volume: 5µl; Storage Conditions: 1-30°C; Shelf Life: 12 months; Sensitivity/Specificity: 99.0%/98.6%
name: Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT)
other_name: 05FK140 (Global)
05FK141 (Global)
05FK142 (Global)
05FK143 (Global)
Alere Malaria Ag P.f
NxTek™ Eliminate Malaria P.f
type: Diagnostic Test
description: oral tablets: 6 doses of 80/480 mg over 3 days
name: Artemether-lumefantrine (AL)
other_name: AL
type: Drug
Study arms:
design_group_description: Pregnant women will be screened with a malaria HS-RDT and, if positive, treated with artemether-lumefantrine
design_group_title: HS-RDT screening/AL treatment
design_group_type: Experimental
design_group_description: Pregnant women will receive usual antenatal care
design_group_title: Usual antenatal care
design_group_type: No Intervention
Sponsor: Duke University
Collaborators: National Institute of Allergy & Infectious Diseases
Drug name mappings:
name: 复方蒿甲醚
lang: CN
name: Artemether/Lumefantrine
lang: EN
name: アルテメテル/ルメファントリン
lang: JP
Clinical trial NCT05900427: Effects on Postoperative Pain of Liposomal Bupivacaine in Interscalene Blocks for Total Shoulder Arthroplasty Patients
Official title: A Double-Blind Randomized Comparison Trial of Postoperative Pain in Patients Undergoing Total Shoulder Arthroplasty Who Receive Interscalene Blocks With or Without Liposomal Bupivacaine (PoPTSAWoW Trial)
Conditions: Total Shoulder Arthroplasty
Reverse Total Shoulder Arthroplasty
Summary: The purpose of this trial is to compare the difference in the proportion of patients with tolerable pain scores, VAS pain scores, quality of recovery and opioid use in milligram equivalents (at 24, 48, 72, 96 and 120 hours postoperatively) in patients undergoing shoulder arthroplasty who receive interscalene blocks with or without Liposomal Bupivacaine.
This is a prospective randomized, double-blinded, controlled trial that will enroll 130 subjects undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty. Participants who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either 36 mL of 0.5% bupivacaine (PB group) or 10 mL of liposomal bupivacaine and 20 mL of 0.25 % bupivacaine and 6 mL of saline (LB group).
Interventions:
description: Subjects randomized to the Liposomal bupivacaine group will receive 10 mL (133 mg) of Liposomal bupivacaine and 20 mL (50 mg) of 0.25% bupivacaine and 6 mL of saline (183 mg).
name: Liposomal bupivacaine
other_name: Exparel
type: Drug
description: Subjects randomized to the Plain Bupivacaine group will receive 36 mL (180 mg) of 0.5% bupivacaine.
name: Bupivacaine
other_name: Marcaine
type: Drug
Study arms:
design_group_description: 10 mL (133 mg) Liposomal bupivacaine and 20 mL (50 mg) 0.25% bupivacaine and 6 mL of saline (183 mg)
design_group_title: Liposomal Bupivacaine Group
design_group_type: Experimental
design_group_description: 36 mL (180 mg) 0.5% bupivacaine
design_group_title: Plain Bupivacaine Group
design_group_type: Other
Sponsor: Endeavor Health
Collaborators: Endeavor Health
Drug name mappings:
name: 布比卡因脂质体
lang: CN
name: Bupivacaine liposome
lang: EN
Clinical trial NCT03797014: B/F/TAF Switch Study for HIV-HBV Coinfection
Official title: Efficacy, Safety, and Tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Adults With HIV-HBV Coinfection
Conditions: HIV-1-infection
Hepatitis B
Summary: The primary objective of this study is to evaluate the efficacy and safety of fixed dose combination (FDC) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in adults coinfected with both HIV-1 and hepatitis B. As this is a switch study, all eligible subjects enrolled will be switched from their current antiretroviral regimen to B/F/TAF will be followed on treatment for 48 weeks.
Interventions:
description: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.
name: B/F/TAF
other_name: Bictegravir/emtricitabine/tenofovir alafenamide
type: Drug
Study arms:
design_group_description: Treatment group (1-arm study)
design_group_title: B/F/TAF
design_group_type: Experimental
Sponsor: University of Maryland Baltimore
Collaborators: Gilead Sciences, Inc.
Drug name mappings:
name: 富马酸丙酚替诺福韦/恩曲他滨/比克替拉韦
lang: CN
name: Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate
lang: EN
name: ビクテグラビルナトリウム/エムトリシタビン/テノホビル アラフェナミドフマル酸塩
lang: JP
Clinical trial NCT06563102: Study to Investigate Changes in Airway Inflammation, Symptoms, and Rescue Therapy Utilization With AIRSUPRA Compared to Albuterol as Needed in Adults With Mild Asthma
Official title: A 12-week, Randomized, Double-Blind, Phase 4 Study Evaluating the Effect of AIRSUPRA Compared to Albuterol Administered as Needed on Changes in Airway Inflammation, Symptoms, and Rescue Therapy Utilization in Adults With Mild Asthma
Conditions: Mild Asthma
Summary: The purpose of this study is to compare the efficacy and safety of albuterol/budesonide to albuterol in changes in airway inflammation, asthma symptoms, and rescue therapy utilization in adults with mild asthma.
Study details include:
* The study duration will be up to 15 weeks.
* The treatment duration will be 12 weeks.
* The visit frequency will be once every 4 weeks, with 3 clinic visits and 2 video calls in total.
Interventions:
description: Oral Inhalation. Rescue medication. Unit dose strength of 80 μg budesonide and 90 μg albuterol per actuation
name: Albuterol/Budesonide
other_name: AIRSUPRA
BDA MDI HFA
type: Combination Product
description: Oral Inhalation. Rescue medication. Unit dose strength of 90μg albuterol per actuation.
name: Albuterol
other_name: AS MDI
type: Combination Product
Study arms:
design_group_description: Participants will be randomized based on Visit 1 FeNO levels (< 50 ppb / ≥ 50 ppb) and geographic region. Participants who are randomized to receive albuterol/budesonide for as-needed rescue therapy will be compared to participants randomized to receive albuterol for as-needed rescue therapy.
design_group_title: Group 1 - Participants randomized to receive albuterol/budesonide
design_group_type: Experimental
design_group_description: Participants will be randomized based on Visit 1 FeNO levels (< 50 ppb / ≥ 50 ppb) and geographic region. Participants who are randomized to receive albuterol/budesonide for as-needed rescue therapy will be compared to participants randomized to receive albuterol for as-needed rescue therapy.
design_group_title: Group 2 - Participants randomized to receive albuterol
design_group_type: Active Comparator
Sponsor: AstraZeneca PLC
Collaborators: Fortrea, Inc.
Drug name mappings:
name: 沙丁胺醇/布地奈德
lang: CN
name: Albuterol/Budesonide
lang: EN
Clinical trial NCT00314327: Optimizing Response in Psychosis Study
Official title: Optimizing Response in Psychosis Study
Conditions: Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Psychotic Disorder Not Otherwise Specified
Summary: The purpose of this project is to evaluate the efficacy of long-acting risperidone for patients with first episode schizophrenia spectrum who did not improve sufficiently with the first antipsychotic medication they tried during their initial treatment trial.
Interventions:
description: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.
name: long-acting injectable risperidone
other_name: Risperdal (oral) & Risperdal Consta
type: Drug
Study arms:
design_group_description: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.
design_group_title: long-acting injectable risperidone
design_group_type: Experimental
Sponsor: Northwell Health, Inc.
Collaborators: National Alliance for Research on Schizophrenia & Depression
Drug name mappings:
name: 利培酮
lang: CN
name: Risperidone
lang: EN
name: リスペリドン
lang: JP