PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT02417649: Advanced Immunological Approach in COPD Exacerbation
Official title: Sublingual Administration of a Polyvalent Mechanical Bacterial Lysate in Patients With Moderate, Severe or Very Severe COPD According to GOLD Classification: a Multicenter, Double Blind, Randomized, Controlled, Phase IV Study
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Summary: Chronic obstructive pulmonary disease (COPD) are characterized by frequent relapses, often resulting from common bacterial infections. Enhancing the immune response in these patients may decrease the frequency of these relapses. The use of a mechanic Polyvalent Bacterial Lysate (PMBL, Ismigen, 13 bacterial strains)may enhance the immune response and therefore help significantly to the control of relapse in these patients.
In the current study the effect of the administration of the PBML to patients older than 40 years, with moderate, severe or very severe COPD, in good or discrete physical condition on the number of relapses in an observation period of 12 months. In addition, the effect of the PMBL on the duration of the interval between relapses, on relapse symptoms, on the use of other drugs, on the number of days of absence of work, on the number of hospitalizations and duration thereof and on potential toxicity of the treatment.
Interventions:
description: 1. The placebo will be administered for a period of three months. The first ten days of each month, one tablet per day will be given. The tablet will be melted under the tongue. After the ten day therapy, a twenty day of rest will be provided. Then the second and the third month the administration schedule will be identical.<br/>2. Three months of rest, according to the indications, will be allowed.<br/>3. A second cycle (the same as point 1.) will be performed<br/>4. A second three month rest (according to point 2.) will be provided.
name: Placebo
type: Biological
description: 1. The tablet will be administered for a period of three months. The first ten days of each month, one tablet per day will be given. The tablet will be melted under the tongue. After the ten day therapy, a twenty day of rest will be provided. Then the second and the third month the administration schedule will be identical.<br/>2. Three months of rest, according to the indications, will be allowed.<br/>3. A second cycle (the same as point 1.) will be performed<br/>4. A second three month rest (according to point 2.) will be provided.
name: Ismigen
type: Biological
Study arms:
design_group_description: Treatment over 3 successive months. One sublingual tablet every day on the first ten days of each month, followed by twenty days of rest.
design_group_title: Ismigen
design_group_type: Experimental
design_group_description: Treatment over 3 successive months. One sublingual tablet every day on the first ten days of each month, followed by twenty days of rest.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Lallemand Pharma AG
Collaborators: Sprim Advanced Life Sciences SL
Drug name mappings:
name: Ismigen
lang: EN
Clinical trial NCT02041767: Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration
Official title: Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration
Conditions: Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection
Summary: The purpose of this study is to demonstrate the prostatic diffusion in significant concentration of ertapenem achieved after a pre-operative single administration.
Interventions:
description: One single injection of 1g of ertapenem before surgery
name: Ertapenem
type: Drug
Study arms:
design_group_description: One single perfusion of 1g of ertapenem 1 hour prior to prostate surgical resection
design_group_title: group A
design_group_type: Experimental
design_group_description: One single perfusion of 1g of ertapenem 12 hour prior to prostate surgical resection
design_group_title: group B
design_group_type: Experimental
Sponsor: Assistance Publique des Hôpitaux de Paris SA
Collaborators: Merck Sharp & Dohme Corp.
Drug name mappings:
name: 厄他培南钠
lang: CN
name: Ertapenem Sodium
lang: EN
Clinical trial NCT00541814: Calcineurin Inhibitor Minimisation in Renal Transplant Recipients With Stable Allograft Function
Official title: Calcineurin Inhibitor Minimisation in Renal Transplant Recipients With Stable Allograft Function: A Prospective Randomised Controlled Trial
Conditions: Chronic Allograft Nephropathy
Summary: The purpose of this trial is to ascertain whether the withdrawal of calcineurin inhibitors (CNI) will lead to less kidney transplant damage when compared with minimisation. The investigators will assess this by comparing the degree of damage on kidney biopsies taken before and after minimisation/withdrawal of CNI.
Interventions:
description: Target drug level 50-100 ng/ml or cyclosporine withdrawal
name: Cyclosporine
other_name: Neoral
type: Drug
Study arms:
design_group_description: CNI [Cyclosporine] minimisation Group. Conversion from azathioprine to Myfortic followed by a three month period of cyclosporine weaning to target blood level of 50-100 ng/ml.
design_group_title: 1
design_group_type: Active Comparator
design_group_description: CNI [Cyclosporine] withdrawal Group. Conversion from azathioprine to Myfortic followed by a three month period of cyclosporine weaning to the point of withdrawal.
design_group_title: 2
design_group_type: Experimental
Sponsor: University Hospitals Birmingham Charity
Collaborators: Novartis AG
Drug name mappings:
name: 环孢素
lang: CN
name: Cyclosporine
lang: EN
name: シクロスポリン
lang: JP
Clinical trial NCT00453453: BNP Therapy Observation Unit Outcomes STudy (BOOST)
Official title: BNP Therapy Observation Unit Outcomes STudy
Conditions: Congestive Heart Failure
Summary: The investigators hypothesize that patients admitted to an emergency department (ED) observation unit will have a decreased rate of hospital admissions and ED recidivism when treated with nesiritide versus standard therapy. The investigators also hypothesize that decreasing B-type Natriuretic Peptide (BNP) levels during treatment in an ED observation unit will predict improved patient outcomes.
Interventions:
description: Nesiritide given orally in the emergency department
name: Nesiritide
other_name: Natrecor
type: Drug
Study arms:
design_group_description: Subjects who come into the ED with CHF will be treated with nesiritide
design_group_title: Nesiritide
design_group_type: Experimental
design_group_description: Subjects who come into the ED with CHF will receive standard care treatment
design_group_title: Standard care
design_group_type: No Intervention
Sponsor: Emory University
Collaborators: Scios, Inc.
Drug name mappings:
name: 奈西立肽
lang: CN
name: Nesiritide Recombinant
lang: EN
Clinical trial NCT01188811: Lipoic Acid for Secondary Progressive Multiple Sclerosis (MS)
Official title: Lipoic Acid for Neuroprotection in Secondary Progressive MS
Conditions: Multiple Sclerosis, Chronic Progressive
Summary: The purpose of the study is to determine if lipoic acid can protect the brain and slow disability in secondary progressive multiple sclerosis.
Interventions:
description: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation.
name: lipoic acid
other_name: alpha lipoic acid
type: Drug
description: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation
name: Placebo
type: Drug
Study arms:
design_group_description: 28 subjects receive oral lipoic acid 1200mg daily
design_group_title: Arm 1: lipoic acid
design_group_type: Experimental
design_group_description: 28 subjects receive placebo daily
design_group_title: Arm 2: placebo
design_group_type: Placebo Comparator
Sponsor: VA Office of Research and Development
Collaborators: Oregon Health & Science University
Drug name mappings:
name: 硫辛酸
lang: CN
name: Lipoic acid
lang: EN
Clinical trial NCT00089843: Bone Loss in Women With Anorexia Nervosa
Official title: IGF-1 and Bone Loss in Women Anorexia Nervosa
Conditions: Anorexia Nervosa
Summary: Women with Anorexia Nervosa have been found to have low bone density. The study will determine whether administration of low doses of a natural hormone, testosterone and/or risedronate, a medication to help prevent bone breakdown will improve or prevent bone loss in this condition.
Interventions:
description: Testosterone patch 150mcg daily
name: Testosterone
other_name: Intrinsa
type: Drug
description: Actonel (risedronate) 35mg PO one time weekly
name: Actonel (risedronate)
other_name: Actonel
type: Drug
description: Placebo tablet identical in appearance to active Actonel (risedronate) tablet
name: Placebo Actonel (risedronate)
type: Drug
description: Placebo patch identical in appearance to testosterone patch
name: Placebo testosterone
type: Drug
Study arms:
design_group_description: Placebo Actonel (risedronate) and active testosterone patch
design_group_title: 2
design_group_type: Active Comparator
design_group_description: Active Actonel (risedronate) and active testosterone patch
design_group_title: 3
design_group_type: Active Comparator
design_group_description: Active Actonel (risedronate) and placebo testosterone
design_group_title: 4
design_group_type: Active Comparator
design_group_description: Placebo testosterone patch and placebo Actonel (risedronate)
design_group_title: 1
design_group_type: Placebo Comparator
Sponsor: The General Hospital Corp.
Collaborators: National Institute of Diabetes & Digestive & Kidney Diseases
National Center for Research Resources
Drug name mappings:
name: 睾酮
lang: CN
name: Testosterone
lang: EN
Clinical trial NCT02735031: Exenatide and Impaired Hypoglycaemic Awareness in Type 1 Diabetes
Official title: Effect of the GLP-1 Receptor Agonist Exenatide on Impaired Hypoglycaemic Awareness in Type 1 Diabetes
Conditions: Diabetes Mellitus, Type 1
Hypoglycemia
Summary: Approximately 25% of patients with type 1 diabetes have lost the capacity to timely detect hypoglycaemia, a condition referred to as impaired hypoglycaemic awareness (IHA) that causes a six-fold higher risk of severe, potentially hazardous, hypoglycaemia. IHA is usually the end-result of a process of habituation to recurrent hypoglycemia that is potentially reversible. Treatment with glucagon-like peptide (GLP)-1 Receptor Agonists (1RAs) in addition to insulin therapy may decrease the incidence of hypoglycaemia in patients with type 1 diabetes. This study will test the hypothesis that treatment with the GLP-1RA, exenatide, added to basal-bolus insulin therapy will improve awareness of hypoglycaemia in patients with type 1 diabetes and IHA. In a randomized doubleblind placebo-controlled cross-over trial, patients will be treated for 6 weeks with exenatide (or placebo), after which hypoglycemic symptoms and counterregulatory hormone responses will be examined during a hyperinsulinemic hypoglycemic glucose clamp study.
Interventions:
description: 6 weeks treatment with exenatide on top of insulin treatment
name: Exenatide
other_name: Byetta
type: Drug
description: 6 weeks treatment with placebo on top of insulin treatment
name: Placebo
type: Drug
Study arms:
design_group_description: Exenatide<br/>* week 1-2: 5 µg twice daily<br/>* week 3-6: 10 µg twice daily (if tolerated)
design_group_title: EXENATIDE
design_group_type: Active Comparator
design_group_description: Placebo matched to exenatide<br/>* week 1-2: 5 µg twice daily<br/>* week 3-6: 10 µg twice daily (if tolerated)
design_group_title: PLACEBO
design_group_type: Placebo Comparator
Sponsor: Radboud University Medical Center
Collaborators: AstraZeneca PLC
Drug name mappings:
name: 艾塞那肽
lang: CN
name: Exenatide
lang: EN
name: エキセナチド
lang: JP
Clinical trial NCT02819141: Self-management of Sedative Therapy by Ventilated Patients
Official title: Efficacy of Self-management of Sedative Therapy by Ventilated ICU Patients
Conditions: Critical Illness
Anxiety
Respiratory Failure
Summary: The purpose of this randomized clinical trial is to test the efficacy of dexmedetomidine for the self-management of sedative therapy (SMST) in a sample of critically ill patients receiving mechanical ventilator support. The investigators hypothesis is that self-management of sedative therapy by mechanically ventilated patients in the intensive care unit (ICU), tailored to their individual needs will be more efficacious than nurse-administered sedative therapy in reducing anxiety, which may reduce duration of mechanical ventilator support and occurrence of delirium.
Interventions:
description: Patient will receive a maintenance intravenous infusion of medication (Dexmedetomidine) and have access to self-controlled sedation medication (Dexmedetomidine) for anxiety.
name: Dexmedetomidine
other_name: Precedex
type: Drug
Study arms:
design_group_description: These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team
design_group_title: Control
design_group_type: No Intervention
design_group_description: These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety.
design_group_title: Dexmedetomidine
design_group_type: Experimental
Sponsor: Mayo Clinic
Collaborators: University of Minnesota
National Heart, Lung & Blood Institute
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
Clinical trial NCT01064999: A Trial of High Intensity Versus Low Intensity Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer
Official title: An Open Label, Randomized, Multi-center, Phase II/III Trial of High Intensity Versus Low Intensity Neoadjuvant Chemoradiotherapy With Intensity-modified Radiation Therapy (IMRT) in Local Advanced Rectal Cancer
Conditions: Rectal Cancer
Summary: Neoadjuvant chemoradiotherapy (CRT) has been the standard therapy for local advanced rectal cancer. Pathological complete response (pCR) is an important prognostic factor for local control and survival. A high intensity CRT increases not only the pCR rate, but also toxicity, especially diarrhea. Compared with traditional RT technique, intensity-modified radiation therapy (IMRT) can decrease the toxicity of diarrhea because of low volume of high dose for small bowel. Therefore, IMRT technique provides an opportunity to improve the dose intensity of neoadjuvant CRT. The investigators hypothesize that a higher treatment dose induces a high rate of pCR and design a two-arm trial. in this trial, low intensity CRT includes the whole pelvic irradiation of 50Gy together with Oxaliplatin and Capecitabine weekly. While in high intensity group, additional concomitant 5Gy for primary tumor and a cycle of Xelox are prescribed. All patients will receive a total mesorectal excision (TME) 8 weeks after CRT.
Interventions:
description: CRT:50mg/m2,IV,weekly*5 cycle CT: 130mg/m2,IV,d1,q 21 day
name: Oxaliplatin
type: Drug
description: CRT:625mg/m2,bid,d1-5,q week RT:1000mg/m2,bid,d1-14,q 3 weeks
name: Capecitabine
type: Drug
description: High intensity group:55Gy Low intensity group:50Gy
name: Radiotherapy
type: Radiation
description: Lower anterior resection or abdominoperineal resection
name: Surgery
type: Procedure
Study arms:
design_group_description: (RT 55Gy + CapOx) + a cycle of Xelox + Surgery
design_group_title: High intensity group
design_group_type: Experimental
design_group_description: (RT 50Gy + CapOx) + Surgery
design_group_title: Low instensity group
design_group_type: Active Comparator
Sponsor: Fudan University
Collaborators: Shanghai Renji Hospital Management Co., Ltd.
Zhejiang No. 1 Hospital
Zhejiang Cancer Hospital
Drug name mappings:
name: 奥沙利铂
lang: CN
name: Oxaliplatin
lang: EN
name: オキサリプラチン
lang: JP
name: 卡培他滨
lang: CN
name: Capecitabine
lang: EN
name: カペシタビン
lang: JP
Clinical trial NCT06115499: The PLATINUM Trial: Optimizing Chemotherapy for the Second-Line Treatment of Metastatic BRCA1/2 or PALB2-Associated Metastatic Pancreatic Cancer
Official title: Phase II/III Second-Line NABPLAGEM vs. Nab-Paclitaxel/Gemcitabine in BRCA1/2 or PALB2 Mutant Metastatic Pancreatic Ductal Adenocarcinoma (PLATINUM)
Conditions: Pancreatic Acinar Cell Carcinoma
Pancreatic Adenocarcinoma
Pancreatic Adenosquamous Carcinoma
Pancreatic Carcinoma
Pancreatic Ductal Adenocarcinoma
Pancreatic Squamous Cell Carcinoma
Stage IV Pancreatic Cancer AJCC v8
Summary: This phase II/III trial compares the effect of the 3-drug chemotherapy combination of nab-paclitaxel, gemcitabine, plus cisplatin versus the 2-drug chemotherapy combination of nab-paclitaxel plus gemcitabine for the treatment of patients with pancreatic cancer that has spread to other places in the body (metastatic) and a known genetic mutation in the BRCA1, BRCA2, or PALB2 gene.
Interventions:
description: Given IV
name: Nab paclitaxel
other_name: ABI-007
Abraxane
Albumin-bound Paclitaxel
Protein-bound Paclitaxel
type: Drug
description: Given IV
name: Gemcitabine
type: Drug
description: Given IV
name: Cisplatin
type: Drug
description: Undergo MRI
name: Magnetic Resonance Imaging
other_name: MRI
type: Procedure
description: Undergo CT
name: Computed Tomography
other_name: CAT Scan
CT Scan
type: Procedure
description: Undergo blood sample collection
name: Biospecimen Collection
type: Procedure
Study arms:
design_group_description: Patients receive nab-paclitaxel IV over 30-40 minutes, gemcitabine IV over 30-40 minutes, and cisplatin IV over 30-60 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT throughout the trial. Patients may optionally undergo blood sample collection at baseline and on study.
design_group_title: Arm I (nab-paclitaxel, gemcitabine, cisplatin)
design_group_type: Experimental
design_group_description: Patients receive nab-paclitaxel IV over 30-40 minutes and gemcitabine IV over 30-40 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT throughout the trial. Patients may optionally undergo blood sample collection at baseline and on study.
design_group_title: Arm II (nab-paclitaxel, gemcitabine)
design_group_type: Active Comparator
Sponsor: Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute
Drug name mappings:
name: 白蛋白结合型紫杉醇
lang: CN
name: Albumin-Bound Paclitaxel
lang: EN
name: パクリタキセル(JAN)
lang: JP
name: 盐酸吉西他滨
lang: CN
name: Gemcitabine Hydrochloride
lang: EN
name: ゲムシタビン塩酸塩
lang: JP
name: 顺铂
lang: CN
name: Cisplatin
lang: EN
name: シスプラチン
lang: JP
Clinical trial NCT00704379: Treatment Strategy to Prevent Mood Disorders Following Traumatic Brain Injury
Official title: Treatment Strategy to Prevent Mood Disorders Following Traumatic Brain Injury
Conditions: Traumatic Brain Injury
Summary: The purpose of this study is to examine the efficacy of sertraline to prevent the onset of mood and anxiety disorders during the first six months after traumatic brain injury.
Interventions:
description: an inactive substance
name: Placebo
type: Drug
description: Sertraline and placebo will be given in a double blind fashion via an equal number of identical tablets administered once daily. Once stabilized in the targeted dosage (100 mg per day), sertraline serum levels will be monitored twice during the course of the intervention. Blood samples will be obtained randomly, one during the first and one during the second trimesters of the protocol.
name: Sertraline
other_name: Zoloft
type: Drug
Study arms:
design_group_description: Placebo will be given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: Sertraline will be given in a double blind fashion via tablets administered once daily. Once stabilized in the targeted dosage (100 mg per day), sertraline serum levels will be monitored twice during the course of the intervention.
design_group_title: Sertraline
design_group_type: Experimental
Sponsor: Baylor College of Medicine
Collaborators: National Institute of Neurological Disorders & Stroke
Drug name mappings:
name: 盐酸舍曲林
lang: CN
name: Sertraline Hydrochloride
lang: EN
name: セルトラリン塩酸塩
lang: JP
Clinical trial NCT01811940: Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence
Official title: Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence
Conditions: Cocaine Dependence
Summary: The proposed protocol is a multi-site double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (MAS-ER) and topiramate in the treatment of cocaine dependence. 198 patients will be enrolled and 176 patients randomized in a 14-week trial. The proportion of participants achieving sustained cocaine abstinence for three consecutive weeks at the end of the study will be significantly greater for the combined pharmacotherapies group compared to the placebo group.
Interventions:
description: MAS-ER 60mg/day
name: Adderall-ER
other_name: Adderall extended release (MAS-ER)
type: Drug
description: Topiramate 100 mg bid.
name: Topiramate
other_name: Topamax
type: Drug
description: Placebo
name: Placebo
type: Other
Study arms:
design_group_description: Adderall-ER will be taken once per day in the morning or early afternoon since it may be activating. The dose is titrated to 60 mg per day or the maximum tolerated dose over two weeks and maintained for the duration of the study. Topiramate will be taken twice per day in the morning and the evening and titrated to 200mg/day or the maximum tolerated dose over the course of 6 weeks and maintained for the duration of the study.
design_group_title: Adderall-ER and Topiramate
design_group_type: Experimental
design_group_description: Placebo will be packaged in matching gelatin capsules similar to the pills in the active arm. Placebo will be taken as frequently and for the same duration as those taken in the active arm.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: The New York State Psychiatric Institute
Collaborators: National Institute on Drug Abuse
Drug name mappings:
name: 托吡酯
lang: CN
name: Topiramate
lang: EN
name: トピラマート
lang: JP