PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT03096613: Thyroid Hormone Replacement for Subclinical Hypothyroidism and Chronic Heart Failure (ThyroHeart-CHF)
Official title: Efficacy and Safety of Levothyroxine (L-T4) Replacement on Exercise Capability in Chronic Systolic Heart Failure Patients With Subclinical Hypothyroidism: A 24-week, Multi-center, Open Label, Randomized, Parallel Group Trial
Conditions: Heart Failure
Subclinical Hypothyroidism
Summary: Based on accumulating evidence showing that hypothyroid status is associated with poor prognosis among heart failure (HF) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with HF and subclinical hypothyroidism. The study is a prospective, randomized, parallel-group trial to assess the efficacy and safety of levothyroxine replacement on evidence-based HF standard therapy in stable chronic heart failure patients with subclinical hypothyroidism.
Interventions:
description: Levothyroxine is used to normalize the thyroid hormone level of patients allocated to levothyroxine.
name: Levothyroxine
other_name: Euthyrox
type: Drug
Study arms:
design_group_description: The patients allocated to levothyroxine group receive levothyroxine with a starting dose of 12.5ug.
design_group_title: Levothyroxine group
design_group_type: Experimental
design_group_description: The patients in this group receive standard therapy in consistent with the local clinical practice.
design_group_title: Standard therapy group
design_group_type: No Intervention
Sponsor: Fuwai Cardiovascular Hospital
Collaborators: Henan Provincial Peoples Hospital
Tianjin Medical University
Drug name mappings:
name: 左甲状腺素钠
lang: CN
name: Levothyroxine Sodium
lang: EN
name: レボチロキシンナトリウム水和物
lang: JP
Clinical trial NCT00586976: A Phase II/III Study of Continuous Local Anesthetic Infusion in Median Sternotomy Following Cardiac Surgery
Official title: A Phase II/III Study of Continuous Local Anesthetic Infusion in Median Sternotomy Following Cardiac Surgery
Conditions: Cardiac Surgery
Summary: Cardiac surgery is associated with pain in the post-operative period. We plan to conduct a study of local anesthetic, ropivacaine, infusion into the sternal wound in adult patients undergoing cardiac surgery to see if it will be safe and result in improved pain control and reduced time to extubation, duration of ICU and hospital stay.
Interventions:
description: 0.3% ropivacaine infusion at 4 ml/hr for 64 hours.
name: Ropivacaine
type: Drug
description: Normal saline infusion at 4 ml/hour for 64 hours.
name: Normal saline
type: Drug
Study arms:
design_group_description: Ropivicaine infusion into the sternal wound
design_group_title: 1
design_group_type: Experimental
design_group_description: Normal saline infusion into the sternal wound
design_group_title: 2
design_group_type: Placebo Comparator
Sponsor: Mayo Clinic
Collaborators: Stryker Nordic
Drug name mappings:
name: 盐酸罗哌卡因
lang: CN
name: Ropivacaine Hydrochloride
lang: EN
name: ロピバカイン塩酸塩水和物
lang: JP
Clinical trial NCT01324999: Tadalafil for Sarcoidosis Associated Pulmonary Hypertension
Official title: Tadalafil for Sarcoidosis Associated Pulmonary Hypertension
Conditions: Pulmonary Hypertension
Summary: This study is designed to assess safety and efficacy of tadalafil in patients with Sarcoidosis Associated Pulmonary Hypertension.
Hypothesis: Tadalafil is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis
Interventions:
description: 20mg/day for one month then 40mg/day for additional 4 months
name: Tadalafil
type: Drug
Study arms:
design_group_description: Single-arm open-label proof of concept study of tadalafil in patients with sarcoidosis associated pulmonary hypertension.
design_group_title: Sarcoid Associated Pulm. Hypertension
design_group_type: Experimental
Sponsor: The University of North Carolina at Chapel Hill
Collaborators: University of Cincinnati (Ohio)
United Therapeutics Corp.
Eli Lilly & Co.
Drug name mappings:
name: 他达拉非
lang: CN
name: Tadalafil
lang: EN
name: タダラフィル
lang: JP
Clinical trial NCT00443222: Treatment With TNF Blockade, Infliximab, in Patients With Myositis
Official title: An Open Trial With TNF Blockade With Infliximab (Remicade®), in Patients With Chronic Inflammatory Myopathies
Conditions: Refractory Myositis
Summary: This is a 4 month open trial with TNF-blockade using infliximab (an antibody that blocks TNF) in adult patients with chronic myositis (polymyositis, dermatomyositis, inclusion body myositis) who have persisting muscle weakness and inflammatory active disease despite adequate treatment with immunosuppressives either currently or previously.
Infliximab is given as infusions, 5 mg/kg body weight, these infusions are repeated after 2, 6 and 14 weeks. The study involves 15 adult patients.
Primary outcome measure is muscle function assessed by muscle function index score.
Other outcome measures are Myositis Disease Activity core set: Patient's global assessment and physicians global assessment on visual analogue scales (VAS). Manual muscle test, Health assessment questionnaire (HAQ), serum levels of CPK, LD and extra muscular disease activity score. Muscle biopsy, Magnetic resonance imaging (MRI) of thigh muscles and Health related Quality of life, measured by SF-36.
Interventions:
name: Infliximab
type: Drug
Study arms:
Sponsor: Karolinska Institutet
Collaborators: The Medical Research Council
Schering-Plough Corp.
Drug name mappings:
name: 英夫利西单抗
lang: CN
name: Infliximab
lang: EN
name: インフリキシマブ（遺伝子組換え）
lang: JP
Clinical trial NCT04314362: Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)
Official title: A Single-center, Vehicle-controlled, Study to Evaluate Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)
Conditions: Meibomian Gland Dysfunction
Summary: Single-center, single-masked (the individual(s) performing efficacy and safety measures will be masked to treatment assignment for the patient(s) they are assessing), vehicle-controlled, randomized study.
Interventions:
description: AZR-MD-001 (1.0%) and suitable excipient
name: AZR-MD-001 ointment/semi-solid drug
type: Drug
Study arms:
design_group_description: AZR-MD-001 ointment/semi-solid drug (1.0%)
design_group_title: AZR-MD-001 Active
design_group_type: Experimental
design_group_description: AZR-MD-001 ointment/semi-solid drug (1.0%) plus Hylo-Forte®
design_group_title: AZR-MD-001 Active + Conventional Treatment
design_group_type: Experimental
design_group_description: AZR-MD-001 vehicle control
design_group_title: AZR-MD-001 vehicle
design_group_type: Experimental
Sponsor: Azura Ophthalmics Ltd.
Collaborators: The University of New South Wales
Drug name mappings:
name: AZR-MD-001
lang: EN
Clinical trial NCT02065843: Three Anxiolytic Drugs Used in Third Molar Surgery
Official title: Comparative Study of the Effectiveness of Three Anxiolytic Drugs Used in Third Molar Surgery
Conditions: Dental Anxiety
Impacted Third Molar Tooth
Summary: This study was to compare the effectiveness of three drugs (Passiflora incarnata, Erythrina mulungum, Midazolam) in controlling anxiety in patients undergoing bilateral extraction of asymptomatic, impacted mandibular third molars.
Interventions:
description: 500 mg/single dose/1 hour before dental surgery
name: Mulungu
other_name: Mulungu Matusa, Erytrina mulungu
type: Drug
description: 500 mg/single dose/1 hour before dental surgery
name: Placebo
type: Drug
description: 100 mg/single dose/1 hour before dental surgery
name: Passiflora incarnata
type: Drug
description: 15 mg/single dose/1 hour before dental surgery
name: midazolam
other_name: Dormonid
type: Drug
Study arms:
design_group_description: 500 mg Mulungu Matusa® (Erytrina mulungu, 2 capsules of 250 mg) to be administered v.o., one hour before the surgical procedure.
design_group_title: Mulungu
design_group_type: Active Comparator
design_group_description: 500 mg of starch (2 capsules of 250 mg) to be administered v.o., one hour before the surgical procedure.
design_group_title: placebo
design_group_type: Placebo Comparator
design_group_description: 100 mg Passiflora incarnata (2 capsules of 50 mg) to be administered v.o., one hour before the surgical procedure.
design_group_title: Passiflora incarnata
design_group_type: Active Comparator
design_group_description: 15 mg midazolam (2 capsules of 7.5 mg) to be administered v.o., one hour before the surgical procedure.
design_group_title: midazolam
design_group_type: Active Comparator
Sponsor: Fundação Universidade Federal de Sergipe
Collaborators: University of Campinas
Drug name mappings:
name: 盐酸咪达唑仑
lang: CN
name: Midazolam Hydrochloride
lang: EN
name: 刺桐提取物
lang: CN
name: Erythrina mulungu Extract
lang: EN
name: 西番莲提取物
lang: CN
name: Passiflora incarnata extract
lang: EN
Clinical trial NCT00279422: A Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
Official title: A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
Conditions: Ulcerative Colitis
Summary: The purpose of this study is to compare the efficacy of visilizumab to placebo in subjects with intravenous steroid-refractory ulcerative colitis.
Interventions:
name: visilizumab
type: Drug
name: visilizumab
type: Drug
Study arms:
design_group_title: placebo
design_group_type: Placebo Comparator
design_group_title: visilizumab
design_group_type: Experimental
Sponsor: Abbott Biotherapeutics Corp.
Collaborators: PDL BioPharma, Inc.
Drug name mappings:
name: 维西珠单抗
lang: CN
name: Visilizumab
lang: EN
Clinical trial NCT01271075: Bilastine Updosing - Characterization of Underlying Mechanisms
Official title: Double-blind, Triple Cross-over, Placebo-controlled Study to Assess the Efficacy, Mechanisms, and Safety of Treatment With Bilastine 20 mg, 40 mg and 80 mg in Cold Contact Urticaria (CCU)
Conditions: Cold Contact Urticaria
Summary: This is a double-blind, triple cross-over, placebo-controlled study to assess the efficacy, mechanisms, and safety of treatment with the antihistamine bilastine in patients with cold contact urticaria (CCU).
Efficacy is primarily assessed by a change in critical stimulation time thresholds (CSTT) and critical temperature thresholds (CTT) after treatment with different dosages of bilastine (20 mg, 40 mg, 80 mg). Following a baseline period of 2-4 weeks, patients are randomized to either group A or group B. In group A they are given bilastine 20 mg, 40 mg, placebo and bilastine 80 mg for 7 days each followed by a 14-day washout period at a time. In group B they are given bilastine 80 mg, placebo, 40 mg and 20 mg for 7 days each followed by a 14-day washout period at a time. CSTT and CTT testings are performed at each of 6 visits, skin microdialysis for the assessment of mast cell mediators is performed at V2, V3 and V6. Visits for investigator's assessments are scheduled at day -14 to -28, day 0, day 7, day 28, day 49, and day 70. Overall a max. of 20 subjects with cold contact urticaria will be enrolled.
Interventions:
description: Single dose, oral, 20 mg, 40 mg, 80 mg each for 7 days
name: Bilastine
type: Drug
description: Single dose, oral, 20 mg, 40 mg, 80 mg each for 7 days
name: Bilastine
type: Drug
Study arms:
design_group_description: A: Crossover Bilastine 20 mg, Bilastine 40 mg, Placebo, Bilastine 80 mg
design_group_title: Bilastine A
design_group_type: Active Comparator
design_group_description: B: Crossover Bilastine 80 mg, Placebo, Bilastine 40 mg, Bilastine 20 mg
design_group_title: Bilastine B
design_group_type: Active Comparator
Sponsor: Charité - Universitätsmedizin Berlin
Collaborators: Faes Farma SA
Drug name mappings:
name: 比拉斯汀
lang: CN
name: Bilastine
lang: EN
name: ビラスチン
lang: JP
Clinical trial NCT05578378: Cladribine Combined With G-CSF and Cytarabine as a Salvage Treatment in R/R ALL
Official title: Cladribine Combined With G-CSF and Cytarabine as a Salvage Treatment in Refractory/Relapsed Acute Lymphoblastic Leukemia
Conditions: Acute Lymphoblastic Leukemia
Summary: To explore the efficiency and safety of CLAG regimen in R/R ALL
Interventions:
description: Cladribine combine with cytarabine will be intravenous on days 1-5; G-CSF will be hypodermic injection on day0-5,4 weeks per cycle.
name: Cladribine
other_name: Cytarabine
G-CSF
type: Drug
description: Control arm<br/>Patients in the control arm received the investigator's choice of one of the following three regimens:<br/>FLAG:Fludarabine(30mg/m2)should be intravenous use on day 1-5, granulocyte colony-stimulating factor will be hypodermic injection using 300 μg per day on days 0-5,cytarabine (1.5 mg/m2) every 12 hours, intravenous infusion on day1-5,4 weeks per cycle.<br/>a high-dose cytosine arabinoside-based regimen; a high-dose methotrexate-based regimen
name: Fludarabine
other_name: cytosine arabinoside
methotrexate
type: Drug
Study arms:
design_group_description: Cladribine (5 mg/m2)should be intravenous use on day 1-5, granulocyte colony-stimulating factor will be hypodermic injection using 300 μg per day on days 0-5,cytarabine (1.5 mg/m2) every 12 hours, intravenous infusion on day1-5,4 weeks per cycle.
design_group_title: CLAG arm
design_group_type: Experimental
design_group_description: Patients in the control arm received the investigator's choice of one of the following three regimens:<br/>1. FLAG:Fludarabine(30mg/m2)should be intravenous use on day 1-5, granulocyte colony-stimulating factor will be hypodermic injection using 300 μg per day on days 0-5,cytarabine (1.5 mg/m2) every 12 hours, intravenous infusion on day1-5,4 weeks per cycle.<br/>2. a high-dose cytosine arabinoside-based regimen;<br/>3. a high-dose methotrexate-based regimen
design_group_title: Control arm
design_group_type: Active Comparator
Sponsor: The First Affiliated Hospital of Soochow University
Collaborators: Southeast University Affiliated Zhonda Hospital
Drug name mappings:
name: 克拉屈滨
lang: CN
name: Cladribine
lang: EN
name: クラドリビン
lang: JP
Clinical trial NCT02565511: A Study of CAD106 and CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease
Official title: A Randomized, Double-blind, Placebo-controlled, Two-cohort, Parallel Group Study to Evaluate the Efficacy of CAD106 and CNP520 in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease.
Conditions: Alzheimers Disease
Summary: The purpose of this study was to test whether two investigational drugs called CAD106 and CNP520, administered separately, could slow down the onset and progression of clinical symptoms associated with Alzheimer's disease (AD) in participants at the risk to develop clinical symptoms based on their age and genotype.
Interventions:
description: Participants will be given i.m. injections at Weeks 1, 7, 13 and quarterly i.m. injections (every 13 weeks) thereafter, until the last injection 3 month prior to completion of the Treatment Epoch.
name: CAD106 Immunotherapy
type: Biological
description: Participants will be given i.m. injections at Weeks 1, 7, 13 and quarterly i.m. injections (every 13 weeks) thereafter, until the last injection 3 month prior to completion of the Treatment Epoch.
name: Placebo to CAD106
type: Other
description: CNP520 50 mg capsule p.o. for the duration of the Treatment Epoch.
name: CNP520
type: Drug
description: Placebo to CNP520 p.o. for the duration of the Treatment Epoch
name: Placebo to CNP520
type: Other
description: Alum was mixed with reconstituted CAD106 as adjuvant therapy to maximize the effectiveness of CAD106
name: Alum
type: Other
Study arms:
design_group_description: CAD106 (450 µg) + Alum (450 µg) intra-muscular injection at Weeks 1, 7, 13 and every 13 weeks thereafter
design_group_title: Cohort I (CAD106)
design_group_type: Experimental
design_group_description: Placebo to CAD106 + Alum (450 µg) intra-muscular injection at Weeks 1, 7, 13 and every 13 weeks thereafter
design_group_title: Cohort I (CAD106 Placebo)
design_group_type: Placebo Comparator
design_group_description: CNP520 (50 mg) capsules taken orally once daily
design_group_title: Cohort II (CNP520)
design_group_type: Experimental
design_group_description: Matching Placebo to CNP520 capsules taken orally once daily
design_group_title: Cohort II (CNP520 Placebo)
design_group_type: Placebo Comparator
Sponsor: Novartis Pharmaceuticals Corp.
Collaborators: Banner Alzheimer's Institute
Amgen, Inc.
National Institute on Aging
Drug name mappings:
name: Amilomotide
lang: EN
name: Umibecestat
lang: EN
Clinical trial NCT01488136: Use of Diazoxide in Acute Hypoglycaemia
Official title: Use of Diazoxide in Acute Hypoglycaemia
Conditions: Type 1 Diabetes
Summary: The investigators know that intensive insulin therapy and tight glucose control is associated with reduction of diabetic complications. However, many patients on insulin don't achieve this because of the risk and the fear of hypoglycaemia (too low blood glucose).
There has been a lot of work done recently looking at the mechanisms by which the brain detects hypoglycaemia. A key player is a potassium channel in the brain (KATP channel). Studies have shown that when these channels are opened, there is a release of hormones such as adrenaline that can help in raising blood sugars to counteract and increase awareness of hypoglycaemia. The investigators study aims to look at an old drug called diazoxide, which is able to open KATP channels.
The investigators aim to see if diazoxide will amplify the release of hormones such as adrenaline when the blood sugar is low. If this is the case, this will aid quicker recovery following hypoglycaemia.
The investigators aim to do this by performing a well established experimental protocol that has been performed safely over the last 20 years called a clamp study. The clamp study will involve slowly bringing the blood sugars down using insulin and intravenous glucose in a controlled fashion. The main outcome will be the hormonal responses (adrenaline response) at a blood sugar level of 2.5mmol/L. Symptoms of hypoglycaemia will be monitored, as well as working memory tests using standardised questionnaires.
The design of the investigators study will be a randomised trial comparing the effects of diazoxide with placebo in which all patients will receive both diazoxide and placebo in random order (crossover design).
Interventions:
description: Diazoxide 7mg/kg, given 2 hours before the start of the clamp study
name: Diazoxide
other_name: Eudemine (Diazoxide)
type: Drug
description: Lactose Ph capsules (Placebo)
name: Placebo
other_name: Lactose Ph capsules (Placebo)
type: Drug
Study arms:
design_group_description: Oral diazoxide 7 mg/kg
design_group_title: Diazoxide
design_group_type: Active Comparator
design_group_description: Matched placebo
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: University Of Dundee
Collaborators: Juvenile Diabetes Research Foundation
Drug name mappings:
name: 二氮嗪
lang: CN
name: Diazoxide
lang: EN
name: ジアゾキシド
lang: JP
Clinical trial NCT05118490: Comparing Treatment Completion Of Daily Rifapentine & Isoniazid For One Month (1HP) To Weekly High Dose Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in Household Contacts of Recently Diagnosed Tuberculosis Patients
Official title: A Randomized Trial Comparing Treatment Completion of Daily Rifapentine & Isoniazid for One Month (1HP) To Weekly Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in HIV-negative Household Contacts of Recently Diagnosed Tuberculosis Patients, The "One To Three" Trial
Conditions: HIV Seropositivity
Tuberculosis
Household Contact
Summary: A multicenter, randomized, stratified, open-label, phase IV trial among HIV-positive persons (PLHIV) on antiretroviral therapy (ART), or HIV-negative household contacts of patients with rifampicin-sensitive pulmonary tuberculosis (TB), who do not have evidence of active TB.
Interventions:
description: Arm A: isoniazid (300mg) and rifapentine (600mg) daily for 4 weeks (1HP)
name: Daily rifapentine and isoniazid for 4 weeks
type: Drug
description: Arm B: isoniazid (900mg) and rifapentine (900mg) weekly for 12 weeks (3HP)
name: Weekly rifapentine and isoniazid for 12 weeks
type: Drug
Study arms:
design_group_title: Group 1: People living with HIV infection without active TB
design_group_type: Experimental
design_group_title: Group 2: HIV-negative household contacts of adults with rifampicin-sensitive pulmonary TB
design_group_type: Experimental
Sponsor: The Aurum Institute
Collaborators: The Johns Hopkins University
Drug name mappings:
name: 利福喷丁
lang: CN
name: Rifapentine
lang: EN
name: 异烟肼
lang: CN
name: Isoniazid
lang: EN
name: イソニアジド
lang: JP
Clinical trial NCT03998709: Effect of Fasting Free Fatty Acids and Fasting Glucose on 1st and 2nd Phase Insulin Secretion
Official title: Effect of Fasting Free Fatty Acids and Fasting Glucose on 1st and 2nd Phase Insulin Secretion
Conditions: Healthy
Summary: Researchers are trying to determine how changes in fasting glucose and free fatty acids (products released from fat) affect insulin secretion.
Interventions:
description: Somatostatin will be used to inhibit endogenous insulin secretion on either study day in both arms of the study
name: Somatostatin
other_name: pancreatic clamp
type: Drug
description: intravenous glucose will be used to raise fasting glucose in people with NFG / NGT
name: Dextrose
other_name: Elevation of glucose
type: Other
description: insulin will be used to lower fasting FFA and glucose in people with IFG / IGT
name: Insulin
other_name: glucose clamp
type: Drug
description: intravenous intralipid (Fat Emulsion) will be used to raise fasting FFA in people with NFG / NGT
name: Intralipid
other_name: Elevation of FFA
type: Other
Study arms:
design_group_description: People with normal fasting glucose and normal fasting FFA (normal fasting glucose / normal glucose tolerance - NFG / NGT) will be studied on 2 occasions. On one occasion they will receive saline overnight and on the other they will receive intralipid and dextrose to raise fasting glucose and fasting FFA. Subsequently (on either study day) they will undergo a hyperglycemic clamp for 2 hours. After this somatostatin will be infused acutely to inhibit endogenous insulin secretion and observe clearance of beta-cell polypeptides.
design_group_title: Elevation of fasting FFA and Glucose
design_group_type: Other
design_group_description: People with elevated fasting glucose and elevated fasting FFA (Impaired fasting glucose / impaired glucose tolerance - IFG / IGT) will be studied on 2 occasions. On one occasion they will receive saline overnight and on the other they will receive insulin to lower fasting glucose and fasting FFA. Subsequently (on either study day) they will undergo a hyperglycemic clamp for 2 hours. After this somatostatin will be infused acutely to inhibit endogenous insulin secretion and observe clearance of beta-cell polypeptides.
design_group_title: Lowering of fasting FFA and glucose
design_group_type: Other
Sponsor: Mayo Clinic
Collaborators: National Institute of Diabetes & Digestive & Kidney Diseases
Drug name mappings:
name: 醋酸生长抑素
lang: CN
name: Somatostatin Acetate
lang: EN