PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT04908982: Aspirin for the Prevention of Preeclampsia in Women With Stage 1 Hypertension
Official title: Aspirin for the Prevention of Preeclampsia in Women With Stage 1 Hypertension: A Pilot Study
Conditions: Pre-Eclampsia
Summary: In 2017, the American College of Cardiology and the American Heart Association changed the diagnostic criteria for hypertension in non-pregnant adults. The parameters for the diagnosis of stage 1 hypertension were revised from a systolic blood pressure (BP) of 140 to 130 mm Hg and a diastolic BP of 90 to 80 mm Hg. Based on new criteria, stage 1 hypertension is associated with a 2-3 fold increased risk of preeclampsia. There are no data regarding prevention of preeclampsia in women with stage 1 hypertension. Low-dose aspirin has been used during pregnancy to prevent preeclampsia for women at high-risk for preeclampsia. Although the precise mechanism remains uncertain, it is possible that low-dose aspirin improves placental perfusion, which results in a decreased rate of preeclampsia. A study that examines the effect of low-dose aspirin on placenta vasculature and tissue elastography by using novel ultrasound tools would be useful. The 2017 Aspirin for Evidence-Based Preeclampsia Prevention trial compared 150 mg aspirin with placebo in women at high-risk of preeclampsia based on a first-trimester screening. They found a significant decrease in the rate of preterm preeclampsia (4.3% vs. 1.6%; P <0.01). Since this study used the screening algorithm including first-trimester serum markers and uterine artery Doppler, the generalizability in the U.S. women with stage 1 hypertension is limited. Our pilot study will examine 1) the effect of low-dose aspirin 81 mg in women with stage 1 hypertension on placental vasculature and shear-wave elastography; 2) the rate of preterm preeclampsia in women with stage 1 hypertension in a control group and in pregnancies treated with low-dose aspirin 81 mg; 3) feasibility of conducting a larger multicenter randomized controlled trial on this subject.
Interventions:
description: 81mg aspirin daily beginning between 12 and 16 weeks of pregnancy and continuing until delivery.
name: Aspirin 81mg
type: Drug
Study arms:
design_group_description: Participants in this arm will be instructed to take 1 81mg aspirin daily beginning between weeks 12 and 16 of pregnancy and continuing until delivery.
design_group_title: Aspirin
design_group_type: Experimental
design_group_description: Participants in this arm will receive no aspirin.
design_group_title: No Aspirin
design_group_type: No Intervention
Sponsor: Eastern Virginia Medical School
Collaborators: AMAG Pharmaceuticals, Inc.
Drug name mappings:
name: 阿司匹林
lang: CN
name: Aspirin
lang: EN
name: サリチル酸
lang: JP
Clinical trial NCT05803096: Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain
Official title: Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain
Conditions: Prostate Disease
Malignancy
Benign Prostatic Hyperplasia
Prostate Cancer
Prostate Adenocarcinoma
Anxiety and Fear
Pain
Summary: Transrectal prostate biopsy is a commonly performed ambulatory procedure for diagnosing prostate cancer. Prostate biopsy are associated with pain or anxiety. Nitrous oxide (or laughing gas) is a well-known inhaled anesthetic which is frequently used in dental offices and for pediatric procedures to alleviate a patient's anxiety and pain. This study seeks to determine whether administration of nitrous oxide at the time of prostate biopsy will improve a patient's experience of care.
Interventions:
description: Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.
name: Self-Administered Nitrous Oxide
other_name: nitrous oxide
type: Drug
description: Oxygen will be administered at 10 Liters/min for the duration of prostate biopsy.
name: Oxygen
type: Other
Study arms:
design_group_description: Patients will receive SANO in addition to periprostatic bupivacaine nerve block for the duration of prostate biopsy.<br/>After the Urologist describes the procedure, the SANO group will have nitrous oxide turned on to 30%, ensuring that the patient is relaxed but still conversant through the procedure. The nitrous will be adjust up or down based on the patient's response to the question "are you feeling the nitrous" and "are you happy at this level". The range will be between 25 - 45%. At the end of the procedure, the SANO group will be turned down to 0% nitrous oxide, and 100% oxygen will be administered through the mask for an additional 2-3 minutes as the patient is cleaned up and repositioned to the supine position.
design_group_title: Self-Administered Nitrous Oxide
design_group_type: Active Comparator
design_group_description: Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy.
design_group_title: Oxygen
design_group_type: Placebo Comparator
Sponsor: Beth Israel Deaconess Medical Center, Inc.
Collaborators: The Brigham & Women's Hospital, Inc.
Drug name mappings:
name: Nitrous Oxide
lang: EN
Clinical trial NCT02202304: The Effects of Chlorhexidine/Thymol Varnish on Partial Denture Patient
Official title: The Effects of Chlorhexidine/Thymol Varnish on the Abutment Teeth in Partial Denture Wearers.
Conditions: Periodontal Disease
Caries
Summary: Cervitec, a chlorhexidine based varnished has been proven to reduce caries risk in younger populations. This study wants to investigate if the use of this product would reduce the risk of losing abutment teeth on patients that are wearing partial dentures as the literature has proven that these teeth are more prone to caries and periodontal disease.
The primary objectives of this research project are to:
1. Assess if the topical application of CHX/thymol varnish every three months on partial denture abutment teeth results in a clinicallu significant decrease in any loss of attachment compared to no application, and
2. Assess if the topical application of CHX/thymol vanirhs every three months on partial denture abutment teeth results in a clinically significant decrease in carious lesion development or progression compared to no application.
The secondary objectives of this research project are to:
1. Assess of the topical application of CHX/thymol varnish every three months on partial denture abutment teeth compared to no application results in a clinically significant difference in:
1. Bleeding on probing (BoP).
2. Plaque formation.
3. Periodontal pocket depths.
4. Microbial composition and GCF cytokine profile of the sub gingival environment.
5. The patients self perception of oral health.
Interventions:
description: This will be applied on abutment teeth on partial denture wearers every 3 months during a period of 2 years.
name: Chlorhexidine/Thymol varnish
other_name: Cervitec Plus (1% chlorhexidine plus 1% thymol)
type: Drug
Study arms:
design_group_description: Participants to the study will receive an application of either the placebo or the product being studied every 3 months. This will be applied on all abutment teeth using a microbrush by "painting" it over the surfaces of these teeth.
design_group_title: Chlorhexidine/Thymol varnish
design_group_type: Experimental
design_group_description: Participants to the study will receive an application of either the placebo or the product being studied every 3 months. This will be applied on all abutment teeth using a microbrush and "painting" it on all the surfaces of these teeth..
design_group_title: Placebo varnish
design_group_type: Placebo Comparator
Sponsor: University of Aberdeen
Collaborators: Ivoclar Vivadent AG
Drug name mappings:
name: 葡萄糖氯己定
lang: CN
name: Chlorhexidine gluconate
lang: EN
name: クロルヘキシジングルコン酸塩
lang: JP
Clinical trial NCT02283905: Amphotericin-B and Voriconazole for Pulmonary Blastomycosis
Official title: Case Series of Continuously-infused Amphotericin-B and Follow-up Voriconazole Therapy for Severe Blastomycosis Pulmonary Infections
Conditions: Blastomycosis
Summary: All patients with pulmonary blastomycosis requiring mechanical ventilation will have their blood concentrations measured for the antifungal drugs, amphotericin-B and voriconazole; as well as an analysis of the susceptibility of their infecting species of blastomyces. This information will then be analyzed relative to their rate of clinical recovery from this serious fungal infection.
Interventions:
description: continuously infused
name: amphotericin-B
other_name: Fungizone
type: Drug
description: intravenously or orally administered
name: voriconazole
other_name: Vfend
type: Drug
Study arms:
design_group_description: Treatment with a 24 hour continuous infusion of amphotericin B deoxycholate at 1.0 mg/kg/day for a total dose of at least 1 g (i.e. <br/> 14 days); and then the patient is stepped down to voriconazole 6 mg/kg i.v. q12h for 2 doses, then 4 mg/kg q12h either i.v. or orally as appropriate. The oral dose will be rounded for convenience to either the 200 mg or 400 mg tablet twice daily.
design_group_title: Amphotericin-B and Voriconazole
design_group_type: Other
Sponsor: University of Manitoba
Collaborators: Pfizer Inc.
Drug name mappings:
name: 两性霉素B
lang: CN
name: Amphotericin B
lang: EN
name: アムホテリシンB
lang: JP
name: 伏立康唑
lang: CN
name: Voriconazole
lang: EN
name: ボリコナゾール
lang: JP
Clinical trial NCT00288782: PET Neuroimaging of [11C]Mirtazapine
Official title: Receptor Occupancy Determined by PET Neuroimaging of [11C]Mirtazapine in Healthy Humans
Conditions: Mental Disorders
Mood Disorders
Affective Disorders
Depressive Disorders
Summary: Recent studies show that 25 - 30% of depressed patients never fully recover, resulting in a treatment-resistant condition. Thus, depression is a major cause of human suffering. We are interested in finding new ways of identifying and alleviating treatment-resistant depression, and we believe that recent advances in brain imaging can contribute to achieving that goal. In this project, we will use a novel compound ([N-methyl-11C]mirtazapine) that we invented for examining the neurochemistry of brain receptors involved in antidepressant actions.
Our compound, [N-methyl-11C]mirtazapine, is closely related to the clinically effective antidepressant drug mirtazapine (Remeron®). It labels several types of noradrenergic receptors that have often been implicated in "stress reactions" as well as depressive disorders. We believe that our compound can identify specific molecular brain dysfunctions that are causally related to treatment-resistant depression.
The purpose of this study is to determine whether there is a reliable relationship between the level of mirtazapine in the bloodstream and the occupancy of neuroreceptors by mirtazapine in the brain. We will apply our standard procedures of PET brain scanning and region-of-interest data analysis, using healthy volunteers who will receive a daily dose of mirtazapine (double-blind design with placebo, 7.5 mg or 15 mg daily for 5 days). We believe that this project could provide a procedure for assessing brain function in treatment-resistant depression, with the aim of improving the guidelines for successful, evidence-based treatment of depression.
Interventions:
name: Mirtazapine
type: Drug
Study arms:
Sponsor: University of Aarhus
Collaborators: Danish Medical Research Council
Drug name mappings:
name: 米氮平
lang: CN
name: Mirtazapine
lang: EN
name: ミルタザピン
lang: JP
Clinical trial NCT04657679: Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based Cohorts
Official title: evaLuation of Variations pharmacokinEtics and phArmacogeNOmics of Ribociclib in rAce-based Cohorts: The LEANORA Study
Conditions: Breast Cancer
Summary: The aim is to determine the pharmacological and biochemical association between ribociclib exposure and CYP3A variants in African American/Blacks and Non-Hispanic White patients. The investigators hypothesize that patients treated with ribociclib who are CYP3A5 poor metabolizers may be exposed to higher levels of ribociclib than CYP3A5 intermediate or normal metabolizers. The findings could allow clinicians to tailor treatments to maintain therapeutic doses while limiting toxicities.
Interventions:
description: Patients will receive ribociclib 600 mg oral (PO) daily for 21 consecutive days of 28-day cycles and endocrine therapy with either letrozole or fulvestrant. Fulvestrant 500 mg intramuscular (IM) will be administered on days 1, 15, 29 of cycle one, and then monthly. Letrozole 2.5 mg oral daily continuously. If premenopausal women have not undergone bilateral salpingo- oophorectomy, they will receive a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., goserelin leuprolide) for ovarian suppression in combination with fulvestrant or letrozole and ribociclib.
name: Ribociclib
other_name: KISQALI
type: Drug
Study arms:
design_group_description: Subject who self identify as African American or Black with metastatic HR+/HER2- advanced breast cancer (estimate 3 participants who are CYP3A5 poor metabolizers and approximately 15 participants who are CYP3A5 intermediate or normal metabolizers)
design_group_title: African American/Black
design_group_type: Active Comparator
design_group_description: Subjects who self-identify as non-Hispanic White with metastatic HR+/HER2- advanced breast cancer (estimate 3 participants who are CYP3A5 poor metabolizers and approximately 15 participants who are CYP3A5 intermediate or normal metabolizers)
design_group_title: Non-Hispanic White
design_group_type: Active Comparator
Sponsor: Georgetown University
Collaborators: National Cancer Institute
The Breast Cancer Research Foundation
MedStar Research Institute
Drug name mappings:
name: 琥珀酸瑞波西利
lang: CN
name: Ribociclib Succinate
lang: EN
Clinical trial NCT06455813: What Laxative Should be Used After Hip Fracture Surgery?
Official title: Oral Laxatives After Hip Fracture Surgery: A Randomised Controlled Trial
Conditions: Hip Fractures
Summary: To conduct a randomized clinical trial to determine how best to prevent constipation after hip fracture surgery using laxatives.
Interventions:
description: The patients' stool frequency, degree of constipation and side effects of the medication as well as pain, nausea and flatulence are scored once a day using the Bristol Stool Scale, Verbal Rank Scale and Patient Assessment of Constipation symptoms Questionnaire. If the first defecation has not occurred 72 hours after the end of the operation, the patients in all three groups are transferred to treatment with peristaltic-promoting agents
name: Bisacodyl
other_name: Dulcolax
type: Drug
description: The patients' stool frequency, degree of constipation and side effects of the medication as well as pain, nausea and flatulence are scored once a day using the Bristol Stool Scale, Verbal Rank Scale and Patient Assessment of Constipation symptoms Questionnaire. If the first defecation has not occurred 72 hours after the end of the operation, the patients in all three groups are transferred to treatment with peristaltic-promoting agents
name: Macrogol 3350 and electrolytes
other_name: Gangiden
type: Drug
description: The patients' stool frequency, degree of constipation and side effects of the medication as well as pain, nausea and flatulence are scored once a day using the Bristol Stool Scale, Verbal Rank Scale and Patient Assessment of Constipation symptoms Questionnaire. If the first defecation has not occurred 72 hours after the end of the operation, the patients in all three groups are transferred to treatment with peristaltic-promoting agents
name: A combination of macrogol 3350 and electrolytes and bisacodyl
other_name: A combination of Gangiden og Dulcolax
type: Drug
Study arms:
design_group_description: Powder for oral solution in sachet Macrogol 3350 and electrolytes (ATC code A06AD65) which is administered orally as the content of 2 sachets daily (in the evening) during admission
design_group_title: Macrogol 3350 and electrolytes.
design_group_type: Active Comparator
design_group_description: Enteric coated tablet Bisacodyl (ATC code A06AB02) 5 mg, 2 tablets daily which is administered orally daily (in the evening) during admission
design_group_title: Bisacodyl
design_group_type: Active Comparator
design_group_description: Powder for oral solution in sachet macrogol 3350 and electrolytes (ATC code A06AD65) which is administered orally daily (in the evening) as the content of 1 sachet given in combination with enteric coated tablet Bisacodyl (ATC code A06AB02) 5 mg, 1 tablet orally daily (in the evening) during admission
design_group_title: A combination of macrogol 3350 and electrolytes and bisacodyl
design_group_type: Active Comparator
Sponsor: Odense University Hospital
Collaborators: InnovationsFonden
Drug name mappings:
name: 比沙可啶
lang: CN
name: Bisacodyl
lang: EN
name: ビサコジル
lang: JP
Clinical trial NCT01490398: Rosuvastatin Effect on Serial Echocardiographic Measurement of Coronary Flow Velocity Reserve
Official title: Effect of Rosuvastatin on Coronary Flow Reserve in Hypertensive Patients
Conditions: Hypertension
Cardiovascular Risk Factors
Summary: In ASCOT study, lipid lowering with a statin provided additional beneficial effects in hypertensive patients with average levels of serum total cholesterol. However, the underlying mechanism of statins to improve clinical outcomes in hypertension is unclear and the effect of statins on coronary flow reserve (CFR) has not been examined in hypertensive patients. Therefore, it is clinically important and timely project to measure CFR non-invasively using echocardiography and to elucidate the mechanism of clinical benefits of statins in hypertensive patients with cardiovascular risk. The investigators try to evaluate the effect of rosuvastatin on CFR by measuring the change of CFR after 1 year treatment of rosuvastatin, and to correlate CFR with LDL-cholesterol and CRP.
Interventions:
description: After baseline assessment, the starting dose of rosuvastatin 10 mg will be given to study patients. If tolerated and LDL-C is > 100mg/dL after 2-4 weeks, the dose will be increased to 20 mg. Rosuvastatin treatment is scheduled to continue for 1 year without no further dose titration, and each patient will be followed at 2 months, 6 months and 1 year.
name: Rosuvastatin
other_name: Crestor
type: Drug
Study arms:
design_group_description: Rosuvastatin 10mg qd for 12 months.
design_group_title: Rosuvastatin
design_group_type: Experimental
Sponsor: Asan Medical Center
Collaborators: AstraZeneca PLC
Drug name mappings:
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
Clinical trial NCT04105764: Deep NMB in Ambulatory Gynecological Laparoscopy
Official title: Deep Neuromuscular Blockade to Improve Postoperative Quality of Recovery in Ambulatory Gynaecologic Laparoscopy
Conditions: Muscle Relaxation
Summary: Gynecological laparoscopic surgery is commonly performed as an ambulatory basis for the aim of rapid discharge, reduce hospital stay with reduced costs and to improve postoperative QOR [1,2]. However, the creation of pneumoperitoneum during laparoscopy may cause postoperative pain and other physiological changes [3], which could influence the postoperative QOR negatively [4]. Poor postoperative QOR leads to prolonged hospital stay [5].
Interventions:
description: DEEP block to PTC 1-3
name: Rocuronium
other_name: Neuromuscular blocker
type: Drug
description: MODERATE block to TOF1-2
name: Rocuronium bromide
other_name: Neuromuscular blocker
type: Drug
Study arms:
design_group_description: In the deep NMB-group, a PTC of 1 to 2 twitches was maintained, and NMB was reversed with sugammadex at the end of surgery.
design_group_title: DEEP BLOCK
design_group_type: Active Comparator
design_group_description: In the moderate NMB group, a TOF count of 1 to 2 was maintained and NMB was reversed with a combination of neostigmine and glycopyrolate at the end of surgery.
design_group_title: Moderate block
design_group_type: Active Comparator
Sponsor: Ain Shams University
Collaborators: Elite Medical Center
Drug name mappings:
name: 罗库溴铵
lang: CN
name: Rocuronium Bromide
lang: EN
name: ロクロニウム臭化物
lang: JP
Clinical trial NCT02145611: Vildagliptin vs. Glibenclamide in Endothelial Function in Type 2 Diabetes and Hypertension
Official title: 12-week Randomized Study to Compare the Effect of Vildagliptin vs. Glibenclamide Associated to Metformin in Endothelial Function in Patients With Type 2 Diabetes and Hypertension
Conditions: Type 2 Diabetes Mellitus
Hypertension
Endothelial Dysfunction
Summary: Cardiovascular disease is a major public health problem in our country. Among the causes of cardiovascular diseases are High Blood Pressure (HBP) and Diabetes Mellitus (DM). Type 2 diabetes (DM2) is associated with a twofold risk of cardiovascular disease, and endothelial dysfunction is an early marker of vascular complications. There is evidence of action of glucagon-like peptide 1 (GLP-1) on endothelial cells and vascular smooth muscle. Vildagliptin is a drug used in the treatment of DM2 able to prolong the activity of GLP-1, improving glycemic control and endothelial function.
Objectives: To evaluate the effect of vildagliptin on endothelial function in patients with DM2 and hypertension using the Endo-PAT 2000 device.
Interventions:
description: Glibenclamide
name: Glibenclamide
other_name: Daonil
type: Drug
description: Vildagliptin
name: Vildagliptin
other_name: Galvus
type: Drug
Study arms:
design_group_description: Vildagliptin: Dosage: 100 mg/day; Duration: 12 weeks
design_group_title: vildagliptin
design_group_type: Active Comparator
design_group_description: Glibenclamide: Dosage: 5 mg to 20 mg; Duration: 12 weeks
design_group_title: glibenclamide
design_group_type: Active Comparator
Sponsor: Hospital de Base
Collaborators: Novartis AG
Drug name mappings:
name: 维格列汀
lang: CN
name: Vildagliptin
lang: EN
name: ビルダグリプチン
lang: JP
name: 格列本脲
lang: CN
name: Glyburide
lang: EN
name: グリベンクラミド
lang: JP
Clinical trial NCT02601976: Evaluation of Unipeg® for Response and Ongoing Safety in Pakistani Population
Official title: Response Evaluation of Peginterferon Alfa-2a 180µg 20kDa (Unipeg®) Plus Ribavirin (Ribazole®) in Treatment naïve Pakistani Population With Chronic Hepatitis C Infection
Conditions: Hepatitis C
Summary: Hepatitis C is a global problem, prevalent in developed as well as in the developing countries. New treatment regimens using PegInterferon in combination with ribavirin has led to improved sustained viral response rates for some genotypes. A single arm, open labeled, multicentre trial was conducted to evaluate the response rate and safety of PegInterferon alfa-2a (Unipeg®) plus ribavirin (Ribazole®) for the treatment of patients with chronic hepatitis C infection. RVR at 4 weeks, ETR at 24 weeks for genotype 3 and at 48 weeks for genotype 1 patients and SVR was determined at 24 weeks after completion of treatment. Quality of life at baseline and at follow-up visits were determined using SF-36.
Interventions:
description: PegInterferon alfa-2a 180mcg 20kDa administered subcutaneously once weekly for 24 weeks in genotype 3 and for 48 weeks in genotype 1 patients.
name: Peginterferon alfa-2a
other_name: Unipeg
type: Drug
description: Ribavirin administered orally in a divided daily dose according to body weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
name: Ribavirin
other_name: Ribazole
type: Drug
Study arms:
design_group_description: PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight
design_group_title: PegInterferon alfa-2a and Ribavirin
design_group_type: Experimental
Sponsor: Getz Pharma Pakistan (Pvt) Ltd.
Collaborators: Dimension Research
Drug name mappings:
name: 聚乙二醇干扰素α-2a
lang: CN
name: Peginterferon alfa-2a
lang: EN
name: ペグインターフェロン アルファ‐2a（遺伝子組換え）
lang: JP
name: 利巴韦林
lang: CN
name: Ribavirin
lang: EN
name: リバビリン
lang: JP