PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT03826199: Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)
Official title: Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town, South Africa (Formative Study)
Conditions: Hiv
Summary: The overarching goal of this proposal is to evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal care, to describe the cascade in women initiating PrEP in this setting, and to evaluate the reasons for attrition along the PrEP cascade in a cohort of pregnant and breastfeeding women. The specific aims are to: (1) Evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services; (2) Describe the PrEP cascade of initiation, retention, and adherence in a cohort of 220 HIV-uninfected pregnant and breastfeeding women, (3) Evaluate attrition and associated factors across the PrEP cascade.
Interventions:
description: We will investigate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services. Upon enrollment in the cascade, all women will be offered PrEP counseling and information, and patients will be followed regardless of their choice to initiate PrEP or not. Participants who initiate PrEP will receive TDF-FTC during the study. At each study visit (every 3-months), women will receive counseling on PrEP adherence or on the risks and benefits of PrEP for women not yet initiated. We will evaluate PrEP initiation and adherence in pregnant and breastfeeding women (N=220) from first antenatal care visit through 12 months post-partum.
name: TDF-FTC
other_name: PrEP
Truvada
type: Drug
description: Information about PrEP will be integrated into regular group education in ANC by existing health care providers during discussion about HIV testing and treatment. During every study visit, PrEP counseling (including adherence counseling for women already on PrEP) will be provided. For women not on PrEP, counselling will be provided on PrEP and HIV prevention.
name: Counselling on PrEP in antenatal and postnatal care
type: Behavioral
Study arms:
Sponsor: University of California, Los Angeles
Collaborators: Desmond Tutu Hiv Foundation
University of Cape Town
Drug name mappings:
name: 恩曲他滨替诺福韦
lang: CN
name: Emtricitabine/Tenofovir Disoproxil Fumarate
lang: EN
name: エムトリシタビン/テノホビル ジソプロキシルフマル酸塩
lang: JP
Clinical trial NCT02585947: To Compare the Efficacy of a Prophylactic Use of Tenofovir by Duration for the Non-Hodgkin's Lymphoma
Official title: A Multicenter Study to Compare the Efficacy of a Prophylactic Use of Tenofovir by Duration for the Non-Hodgkin's Lymphoma Patients With Isolated Anti-HBc-positivity Who Will be Treated With Rituximab Based Chemotherapy
Conditions: Non-Hodgkin's Lymphoma, Burkitt's
Summary: The objective of this study is to analyze factors affecting Hepatitis B Virus (HBV) reactivation in anti-HBc positive patients with Non-Hodgkin's lymphoma treated with rituximab and compare HBV reactivation rates by duration of prophylactic treatment with tenofovir to contribute to the establishment of an effective prevention strategy.
Interventions:
description: Anti-HBc positive patients with Non-Hodgkin's lymphoma planned to receive rituximab based chemotherapy will be randomized to either Group A or Group B in a 1:1 ratio and will be monitored every 12 weeks from the start of treatment for up to 72 weeks after the end of chemotherapy (EOC).
name: Tenofovir
other_name: Viread
type: Drug
Study arms:
design_group_description: * prophylactic (preemptive) treatment<br/>* 300mg for 24 weeks<br/>* once daily
design_group_title: tenofovir for 24 weeks
design_group_type: Experimental
design_group_description: * prophylactic (preemptive) treatment<br/>* 300mg for 48 weeks<br/>* once daily
design_group_title: tenofovir for 48 weeks
design_group_type: Experimental
Sponsor: Seoul National University Hospital
Collaborators: Konkuk University Medical Center
Gilead Sciences, Inc.
Drug name mappings:
name: 替诺福韦
lang: CN
name: Tenofovir
lang: EN
Clinical trial NCT03576677: Effect of Levosimendan or Placebo on Exercise in Advanced Chronic Heart Failure
Official title: Effect of Levosimendan or Placebo on Exercise Capacity and Hemodynamics in Patients With Advanced Chronic Heart Failure (LOCO-CHF Trial)
Conditions: Heart Failure
Summary: Purpose: This study evaluates the subacute effect of levosimendan infusion on exercise capacity and exercise hemodynamics compared with placebo in patients with advanced chronic heart failure.
Hypothesis: Treatment with 6 hours infusion of levosimendan compared with placebo improves exercise capacity and exercise hemodynamics evaluated by change in CO/PCWP.
Design: The study is a prospective multi-center, double-blinded, placebo controlled randomized study. 42 consecutive patients who meet the eligibility criteria will be enrolled.
Interventions:
description: Levosimendan, 2.5 mg/mL concentrate for dilution. 5 mL of the study drug will be injected into a 245 mL isotonic glucose solution.<br/>Patients will receive a 6 hours infusion of this study drug at an infusion rate of 0.2 µg/kg/min.
name: Levosimendan
other_name: Simdax
type: Drug
description: The placebo solution will be prepared by adding 10 mL of 5% dextrose to a vial containing Soluvit (vitamin B) under aseptical conditions. 5 mL of this solution is then added to 245 mL of isotonic sodium chloride solution.<br/>5% dextrose and vitamin B are added to ensure yellow coloring indistinguishable from the active drug (levosimendan).<br/>Patients will receive a 6 hours infusion of this study drug. Infusion rate will be calculated in similar fashion to the levosimendan group.
name: Placebo
type: Drug
Study arms:
design_group_description: Study participants in this arm will receive a 6 hours infusion of levosimendan 0.2 µg/kg/min.
design_group_title: Levosimendan
design_group_type: Active Comparator
design_group_description: Study participants in this arm will receive a 6 hours infusion of placebo (sterile isotonic sodium chloride + 5% dextrose + vitamin B)
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Rigshospitalet
Collaborators: Orion Oyj
Drug name mappings:
name: 左西孟旦
lang: CN
name: Levosimendan
lang: EN
Clinical trial NCT02638415: The Effect of Hepatic Vein Pressure Gradient(HVPG)-Guided Therapy in Cirrhotic Patients With Esophagogastric Varices
Official title: The Effect of HVPG-Guided Individualized Therapy in Patients With Cirrhosis Related Esophagogastric Variceal Hemorrhage For Secondary Prophylaxis:A Randomized Controlled Trial
Conditions: Gastroesophageal Varices
Cirrhosis
Summary: The purpose of the study is to compare the effect of HVPG-guided individualized therapy and non-HVPG guided traditional therapy in cirrhotic patients for secondary prophylaxis.
Interventions:
description: Patients with an HVPG over 20mmHg will be suggested to receive transjugular intrahepatic portocaval shunt (TIPS) or surgical shunt operation.<br/>Patients with an HVPG between 16 and 20mmHg can choose either endoscopic treatment or TIPS according their willingness and indication.<br/>Patients with an HVPG below 16mmHg will be treated by endoscopy plus Carvedilol, until endoscopic treatment fails.
name: HVPG-guided therapy
type: Procedure
description: Patients start treatment without HVPG measurement and receive endoscopic therapy plus Carvedilol.
name: routine therapy
type: Other
description: Patients in HVPG group with HVPG below 16mmHg and all patients in non-HVPG group will take Carvedilol 12.5mg/d if they have no contraindications.
name: Carvedilol
type: Drug
Study arms:
design_group_description: HVPG-guided therapy
design_group_title: HVPG group
design_group_type: Experimental
design_group_description: routine therapy
design_group_title: non-HVPG group
design_group_type: Other
Sponsor: Zhongshan Hospital Fudan University
Collaborators: Shanghai Public Health Clinical Center
Shuguang Hospital
Xinhua Hospital
Shanghai Eastern Hepatobiliary Surgery Hospital
Shanghai Pudong New District Gongli Hospital
Shanghai First People's Hospital
Drug name mappings:
name: 卡维地洛
lang: CN
name: Carvedilol
lang: EN
name: カルベジロール
lang: JP
Clinical trial NCT06647342: The Effect of Reduced Bleomycin in Electrochemotherapy Treatment
Official title: Randomised Controlled Clinical Trial Investigating the Effect of Reduced Bleomycin in Elechtrochemotherapy Treatment on Patients with Cutaneous Malignancies (The BLESS Trial)
Conditions: Cutaneous Metastasis
Cutaneous Malignant Mixed Tumor
Bleomycin Adverse Reaction
Electrochemotherapy
Summary: The objective of this trial is to determine if reducing the chemotherapy dose in electrochemotherapy is equally effective as using the standard dose for treating various types of skin tumors.
Electrochemotherapy involves administrating chemotherapy intravenously, followed shortly by a brief electrical pulse to the tumor. This pulses temporarily increases the tumor cells permeability, allowing the chemotherapy to enter more effectively.
Participants will undergo a single session of electrochemotherapy with either half the standard chemotherapy dose or the full standard dose. The size of the cutaneous tumors will be measured before treatment and again three months after the treatment to compare their response in both groups. To monitor the tumors, as well as assess the adverse events and quality of life, participants must attend follow-up visits at two weeks, three months and twelve months. Additional visits may be scheduled at one, two, four and six months, if necessary, as determined by the clinician or the patient. Concentration of chemotherapy will be measured in blood samples and in samples from the treated tumor and normal skin.
Interventions:
description: In the standard arm, Bleomycin (Baxter, Germany) at a dose of 15.000 IU/m² is used. In the dose reduction arm, a dose of 7500 IU/m² is used. Note that in Denmark bleomycin is dosed by international units, whereas other countries may use respectively U (units) or mg.
name: Bleomycin
type: Drug
Study arms:
design_group_description: Patients in this arm will recieve the standard dose of bleomycin during treatment with electrochemotherapy
design_group_title: Standard dose
design_group_type: Active Comparator
design_group_description: Patients in this arm will recieve half the standard dose of bleomycin during treatment with electrochemotherapy
design_group_title: Dose reduction
design_group_type: Experimental
Sponsor: Zealand University Hospital
Collaborators: Herlev Hospital
Roskilde University
Drug name mappings:
name: 盐酸博莱霉素
lang: CN
name: Bleomycin Hydrochloride
lang: EN
name: ブレオマイシン塩酸塩
lang: JP
Clinical trial NCT01356511: High-dose Dexamethasone Versus Conventional Dose Prednisone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)
Official title: High-dose Dexamethasone and Conventional Dose Prednisone, for the First-line Treatment of Adults With ITP: a Multicenter, Randomized Controlled, Clinical Trial
Conditions: Purpura, Thrombocytopenic, Idiopathic
Summary: The project was undertaking by Qilu Hospital of Shandong University and other 11 well-known hospitals in China. In order to report the efficacy and safety of high-dose dexamethasone compared to conventional dose prednisone for the first-line treatment of adults with primary immune thrombocytopenia(ITP).
Interventions:
description: Prednisone, po, 1 mg/kg/d, for 4 weeks.
name: Prednisone
other_name: CD-PRE
type: Drug
description: Dexamethasone, po, 40 mg/d, for 4 days.
name: Dexamethasone
other_name: HD-DXM
type: Drug
Study arms:
design_group_description: Patients in the PDN arm received PDNorally at 1.0mg/kg body weight daily for 4 consecutive weeks.
design_group_title: Prednisone group
design_group_type: Experimental
design_group_description: DXM was administered orally at 40 mg daily for 4 consecutive days and then stopped
design_group_title: Dexamethasone group
design_group_type: Experimental
Sponsor: Shandong University
Collaborators: Ruijin Hospital
Zhejiang Chinese Medicine Hospital
Shenzhen Second People's Hospital
Wuhan Xiehe Hospital Tower
Anhui Shackle Hospital Co., Ltd.
Second Hospital of Shanxi Medical University
Peking Union Medical College Hospital
Xinjiang Autonomous Region People's Hospital
Shandong University of Traditional Chinese Medicene
Drug name mappings:
name: 泼尼松
lang: CN
name: Prednisone
lang: EN
name: 地塞米松磷酸钠
lang: CN
name: Dexamethasone Sodium Phosphate
lang: EN
name: デキサメタゾンリン酸エステルナトリウム
lang: JP
Clinical trial NCT00137657: Impact of Cotrimoxazole Prophylaxis for HIV-Infected Adults on Antifolate Resistance
Official title: An Evaluation of the Impact of Cotrimoxazole Prophylaxis for HIV-Infected Adults on the Development of Antifolate Resistance Among Plasmodium Falciparum, Streptococcus Pneumoniae, and Escherichia Coli
Conditions: HIV
Malaria
Diarrhea
Pneumonia
Opportunistic Infections
Summary: At least three studies in sub-Saharan Africa have demonstrated a decrease in morbidity or mortality among HIV-infected adults who took daily cotrimoxazole (trimethoprim sulfamethoxazole) [CTX] prophylaxis. Because of the demonstrated beneficial effect, high tolerability and low cost of CTX, the United Nations Programme on HIV/AIDS (UNAIDS) recommends that HIV-infected persons with symptomatic HIV or depressed CD4 counts receive daily CTX. The effect of this recommendation on subsequent development of antimicrobial resistance to antifolates among important pathogens needs to be evaluated. The investigators measured the change in the prevalence of markers of antifolate resistance among P. falciparum, and the change in the prevalence of CTX resistance among S. pneumoniae, and E. coli in HIV-infected individuals receiving CTX daily prophylaxis. In addition, the investigators measured the change in the prevalence of naso-pharyngeal or oro-pharyngeal carriage of CTX resistant S. pneumoniae among children living in households where an HIV-infected adult was receiving CTX daily prophylaxis.
Interventions:
name: Cotrimoxazole (trimethoprim sulfamethoxazole)
type: Drug
Study arms:
Sponsor: Centers for Disease Control & Prevention
Collaborators: Kenya Medical Research Institute
Drug name mappings:
name: 磺胺甲噁唑/甲氧苄啶
lang: CN
name: Sulfamethoxazole/Trimethoprim
lang: EN
name: スルファメトキサゾール/トリメトプリム
lang: JP
Clinical trial NCT02859337: Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA
Official title: Improving the Effectiveness of Orally Dosed Emergency Contraceptives in Obese Women - PK and PD of 30mg and 60mg UPA
Conditions: Obesity
Contraception
Summary: Obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed emergency contraceptives. Our preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed emergency contraceptives in obese women. More data is needed regarding emergency contraception containing ulipristal acetate. The overall project will be focused on both levonorgestrel (LNG) - and ulipristal acetate (UPA)-containing emergency contraception but this protocol registration is for the UPA aspect of the study procedures.
Interventions:
description: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC
name: UPA-ECx1
other_name: Ella
Ella-One
type: Drug
description: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC
name: UPA-ECx2
other_name: ella
ella-one
type: Drug
Study arms:
design_group_description: Ulipristal acetate 30mg orally x 1 dose, washout cycle and then in the next menstrual cycle, 60mg x 1 dose. Timing of dosage depends on follicle measurements.
design_group_title: UPA-ECx1 followed by ECx2
design_group_type: Active Comparator
design_group_description: Ulipristal acetate 60mg orally x 1 dose, washout cycle, and then in next menstrual cycle 30mg orally x 1 dose. Timing of dosage depends on follicle measurements.
design_group_title: UPA-ECx2 followed by ECx1
design_group_type: Experimental
design_group_description: Ulipristal acetate 30mg orally x 1 dose. timing of dosage depends on follicle measurements. This is to obtain a normal BMI control group.
design_group_title: UPA-ECx1 Normal BMI/weight
design_group_type: Other
Sponsor: Oregon Health & Science University
Collaborators: National Institutes of Health
Drug name mappings:
name: 醋酸乌利司他
lang: CN
name: Ulipristal Acetate
lang: EN
Clinical trial NCT00000218: Pharmacotherapy and Intensive Treatment - 2
Official title: Pharmacotherapy and Intensive Treatment
Conditions: Cocaine-Related Disorders
Substance-Related Disorders
Summary: The purpose of this study is to evaluate desipramine and carbamazepine in reducing cocaine craving; increase outpatient treatment capacity and evaluate their incidence of psychiatric disorders.
Interventions:
name: Carbamazepine
type: Drug
Study arms:
Sponsor: National Institute on Drug Abuse
Collaborators: VA Office of Research and Development
Drug name mappings:
name: 卡马西平
lang: CN
name: Carbamazepine
lang: EN
name: カルバマゼピン
lang: JP
Clinical trial NCT00452543: Acamprosate Added to Escitalopram and Behavioral Treatment for Comorbid Depression and Alcoholism
Official title: A Double-Blind, Placebo-Controlled Study of Acamprosate Added to Escitalopram and Behavioral Treatment in Major Depressive Disorder (MDD) With Comorbid Alcohol Abuse/Dependence
Conditions: Major Depressive Disorder
Alcohol Abuse
Alcohol Dependence
Summary: This is a study about treatment for people who suffer from both major depression and alcohol abuse or dependence. The study will examine whether the addition of acamprosate to escitalopram and behavioral interventions will improve outcomes for this population.
Interventions:
description: Acamprosate 333mg, 2 capsules by mouth (i.e., PO), three times per day (i.e., TID), for 12 weeks.
name: acamprosate
other_name: Campral
type: Drug
description: Escitalopram is given for 12 weeks. Dosing is flexible, starting at 10mg PO once per day (i.e., QD) with the possibility of increasing to 30mg PO QD.
name: escitalopram
other_name: Lexapro
type: Drug
description: Based on the COMBINE study. 1 hour of medical management / behavioral intervention at every study visit (7 times over 12 weeks).
name: Medical management
other_name: Campral and Lexapro
type: Behavioral
description: Placebo, 2 capsules PO TID, for 12 weeks
name: Placebo
other_name: Campral and Lexapro
type: Drug
Study arms:
design_group_title: Escitalopram plus acamprosate
design_group_type: Experimental
design_group_title: Escitalopram plus placebo
design_group_type: Placebo Comparator
Sponsor: The General Hospital Corp.
Collaborators: National Alliance for Research on Schizophrenia & Depression
Drug name mappings:
name: 草酸艾司西酞普兰
lang: CN
name: Escitalopram Oxalate
lang: EN
name: エスシタロプラムシュウ酸塩
lang: JP
name: 阿坎酸钙
lang: CN
name: Acamprosate Calcium
lang: EN
name: アカンプロサートカルシウム
lang: JP
Clinical trial NCT00505102: Safe Renal Function In Long Term Heart Transplanted Patients
Official title: Efficacy and Safety of Everolimus to SAve REnal Function (SAREFU) in Long Term Heart Transplanted Patients
Conditions: Kidney Diseases
Heart Transplantation
Summary: The purpose of this study is to verify whether the reduction of cyclosporine dosages associated with Everolimus administration may improve renal function as compared to patients maintained on standard immunosuppressive therapy
Interventions:
description: cyclosporine dose reduced of 50% after introduction of everolimus
name: Everolimus
type: Drug
Study arms:
design_group_title: A
design_group_type: Active Comparator
Sponsor: A.O. Ospedale Papa Giovanni XXIII
Collaborators: Istituto di Ricerche Farmacologiche Mario Negri
Drug name mappings:
name: 依维莫司
lang: CN
name: Everolimus
lang: EN
name: エベロリムス
lang: JP
Clinical trial NCT02852577: Long Term Treatment of Panic Disorder With Clonazepam or Paroxetine
Official title: Long-term, Open, Naturalistic, Randomized Clinical Trial With Clonazepam and Paroxetine in Panic Disorder With or Without Agoraphobia
Conditions: Panic Disorder
Agoraphobia
Summary: The purpose of this study was to determine whether clonazepam and paroxetine are effective in the treatment of panic disorder. Efficacy was evaluated in short-term, long-term and post-treatment.
Interventions:
description: Administration of clonazepam once a day, flexible dose (0.5 - 2 mg/day), for 36 months. If no remission after 8 weeks augmentation with paroxetine once a day, flexible dose (10 - 40 mg/day), for 34 months.
name: Clonazepam
type: Drug
description: Administration of paroxetine once a day, flexible dose (10 - 40 mg/day), for 36 months. If no remission after 8 weeks augmentation with clonazepam once a day, flexible dose (0.5 - 2 mg/day), for 34 months.
name: Paroxetine
type: Drug
Study arms:
design_group_description: Treatment with clonazepam
design_group_title: Clonazepam
design_group_type: Active Comparator
design_group_description: Treatment with paroxetine
design_group_title: Paroxetine
design_group_type: Active Comparator
Sponsor: Federal University of Rio de Janeiro
Collaborators: Conselho Nacional de Desenvolvimento Cientifico e Tecnológico
Drug name mappings:
name: 盐酸帕罗西汀
lang: CN
name: Paroxetine Hydrochloride
lang: EN
name: パロキセチン塩酸塩水和物
lang: JP
name: 氯硝西泮
lang: CN
name: Clonazepam
lang: EN
name: クロナゼパム
lang: JP