PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT00941330: Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers
Official title: Randomized Phase II Trial of Pre-Operative Docetaxel-Cytoxan (TC) or Exemestane in Patients With Hormone Receptor-Positive Breast Cancers With Recurrence Scores Greater Than 10 (≥ 11) and Less Than 25 (≤ 24)
Conditions: Breast Cancer
Summary: The patients are being asked to take part in this study because they have a hormone receptor-positive breast cancer (contains estrogen and/or progesterone receptors) and their doctor has told them that they have an option to receive chemotherapy or hormonal therapy before surgery. The purpose of this study is to assess if chemotherapy using docetaxel and cytoxan (TC) or hormonal therapy using exemestane can shrink the size of their breast tumor and allow them to preserve the breast or have less extensive surgery on their breast.
Interventions:
description: 25 mg daily by mouth for 6 to 12 months.
name: Exemestane
other_name: Aromasin
type: Drug
description: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
name: Docetaxel
other_name: Taxotere
type: Drug
description: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
name: Cytoxan
other_name: Cyclophosphamide
type: Drug
Study arms:
design_group_description: ARM A: Patients will be treated with exemestane.
design_group_title: A: Exemestane
design_group_type: Experimental
design_group_description: ARM B: Patients will be treated with docetaxel and cytoxan.
design_group_title: B: Docetaxel and Cytoxan
design_group_type: Active Comparator
Sponsor: Emory University
Collaborators: Pfizer Inc.
Drug name mappings:
name: 依西美坦
lang: CN
name: Exemestane
lang: EN
name: エキセメスタン
lang: JP
Clinical trial NCT02145767: Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial
Official title: Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial
Conditions: Miscarriage
Preterm Birth
Summary: Miscarriages and preterm births are common and serious events affecting women, families, and healthcare systems on many levels. One of the risk factors for miscarriage and preterm birth is bleeding in the first trimester of pregnancy. Progesterone, a hormone that plays a key role during pregnancy, has been proposed as a possible medication to be used in pregnancy to prevent miscarriage and preterm birth among women who have bleeding in their first trimester of pregnancy. Unfortunately, unless sound clinical evidence is obtained through a clinical trial, whether or not progesterone can indeed prevent miscarriage and preterm birth remains uncertain and thus is not a recommended treatment in women with early pregnancy bleeding. The purpose of our study is to evaluate the effect of progesterone for the prevention of miscarriage and preterm birth among women with early pregnancy bleeding. We will carry out a clinical trial in which 850 women will be randomized to receive either progesterone supplementation (425 women) or a similarly appearing placebo (425 women) and the outcome of their pregnancy will be compared.
Interventions:
name: Progesterone
type: Drug
name: Placebo
type: Drug
Study arms:
design_group_description: Progesterone 200mg suppository administered vaginally at bedtime until 34 completed weeks of pregnancy.
design_group_title: Progesterone
design_group_type: Experimental
design_group_description: Similar appearing suppository containing vehicle alone administered vaginally at bedtime until 34 completed weeks of pregnancy.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: The Jewish General Hospital
Collaborators: Canadian Institutes of Health Research
Drug name mappings:
name: 黄体酮
lang: CN
name: Progesterone
lang: EN
name: プロゲステロン
lang: JP
Clinical trial NCT05200260: Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer
Official title: A Prospective, Multicenter, Randomized Phase II Trial on Optimal Timing of Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Summary: Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer
Interventions:
description: Primary debulking surgery with a maximum cytoreduction, then followed by 6 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5.
name: Primary debulking surgery
other_name: PDS
type: Procedure
description: 3 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5, Interval debulking surgery with a maximal cytoreduction of complete gross resection, then followed by another 3 cycles of chemotherapy.
name: Neoadjuvant chemotherapy
other_name: Neoadjuvant chemotherapy followed by interval debulking surgery, NACT-IDS
type: Procedure
description: For patients with BRCA mutated, maintenance therapy of PARP inhibitors following CR/PR after first-line chemotherapy. In this trial, Olaparib 300mg p.o. twice daily is suggested after the front-line therapy.
name: PARP inhibitor
other_name: Olaparib
type: Drug
description: For patients without BRCA mutated, maintenance therapy of Bevacizumab following CR/PR after first-line chemotherapy. In this trial, Bevacizumab 7.5mg per kilogram intravenous once every 3 weeks is suggested after the front-line therapy.
name: Bevacizumab
type: Drug
Study arms:
design_group_description: Primary debulking surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ).
design_group_title: Upfront cytoreductive surgery with maintenance therapy
design_group_type: Experimental
design_group_description: Neoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ).
design_group_title: Neoadjuvant chemotherapy with maintenance therapy
design_group_type: Active Comparator
Sponsor: Shanghai Gynecologic Oncology Group
Collaborators: Fudan University
Drug name mappings:
name: 贝伐珠单抗
lang: CN
name: Bevacizumab
lang: EN
name: ベバシズマブ（遺伝子組換え）
lang: JP
Clinical trial NCT00123656: Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis
Official title: Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis
Conditions: Esophagitis
Summary: Eosinophilic esophagitis (EE) is a recently recognized entity. It has been thought to be related to both allergies and acid reflux. There have been reports that both swallowed, aerosolized steroids and proton pump inhibitors have been effective treatments. The researchers propose to directly compare the efficacy of aerosolized fluticasone to esomeprazole in the treatment of eosinophilic esophagitis. The hypothesis is that aerosolized fluticasone (Flovent) will be more effective in relieving symptoms of EE than esomeprazole (Nexium) treatment. Patients will undergo endoscopy, pH monitoring and manometry for diagnosis. Following diagnosis of EE by pathology (biopsy of esophagus), patients will be randomized to esomeprazole or swallowed fluticasone for 8 weeks. At the end of 8 weeks, subjects will be asked to repeat upper endoscopy with biopsies. Three questionnaires (dysphagia, gastroesophageal reflux disease [GERD], and allergy) will be completed by the patient at the first endoscopy and at the end endoscopy. The primary objective is to measure change in eosinophil infiltration of the esophagus in response to treatment of allergy (swallowed fluticasone) versus treatment for reflux (esomeprazole) in EE patients.
Interventions:
description: esomeprazole dosed qam for 8 weeks
name: esomeprazole
other_name: Nexium
type: Drug
description: fluticasone dosed 220 mcg 2 puffs swallowed BID for 8 weeks
name: fluticasone
other_name: Flovent
type: Drug
Study arms:
design_group_description: fluticasone
design_group_title: 1
design_group_type: Active Comparator
design_group_description: esomeprazole
design_group_title: 2
design_group_type: Active Comparator
Sponsor: University of Utah
Collaborators: American Society for Gastrointestinal Endoscopy
Drug name mappings:
name: 埃索美拉唑镁
lang: CN
name: Esomeprazole Magnesium
lang: EN
name: エソメプラゾールマグネシウム水和物
lang: JP
name: 丙酸氟替卡松
lang: CN
name: Fluticasone Propionate
lang: EN
name: フルチカゾンプロピオン酸エステル
lang: JP
Clinical trial NCT06462235: A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)
Official title: A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF AZTREONAM AND AVIBACTAM ± METRONIDAZOLE IN NEONATES AND INFANTS FROM BIRTH TO LESS THAN 9 MONTHS OF AGE WITH SUSPECTED OR CONFIRMED INFECTIONS DUE TO GRAM-NEGATIVE PATHOGENS REQUIRING INTRAVENOUS ANTIBIOTIC TREATMENT
Conditions: Gram-negative Bacterial Infection
Summary: The purpose of this study is to learn about the safety and effects of ATM-AVI for the possible treatment of infections caused by a type of bacteria called gram-negative bacteria.
The study medicine is a combination of an antibiotic, aztreonam (ATM), and another medicine, avibactam (AVI), which is used to help stop bacteria from being resistant to antibiotics. Antibiotics are medicines that fights bacteria and infections.
The study will include newborns and infants up to 9 months of age who are admitted in the hospital.
The study is conducted in 2 parts: Part A and Part B.
In Part A, all participants will receive a single intravenous (injected directly into a vein) infusion of ATM-AVI. This is to study the safety and effects of a single amount.
In Part B, all participants will receive multiple intravenous infusions of ATM-AVI as treatment for a possible or confirmed infection with gram-negative bacteria.
Interventions:
description: Single intravenous infusion of aztreonam-avibactam over 3 hours to assess pharmacokinetics, safety, and toleration.
name: Part A: ATM-AVI Single Dose, Cohorts 1-4
type: Drug
description: Multiple intravenous infusions of aztreonam-avibactam over 3 hours, repeated every 6-8 hours up to 14 days to assess pharmacokinetics, safety, toleration, and efficacy.
name: Part B: Multiple-dose ATM-AVI, Cohorts 1-4
type: Drug
Study arms:
design_group_description: Single dose pharmacokinetics.
design_group_title: Part A, Cohorts 1-4
design_group_type: Experimental
design_group_description: Multi-dose pharmacokinetics and treatment
design_group_title: Part B, Cohorts 1-4
design_group_type: Experimental
Sponsor: Pfizer Inc.
Collaborators: AbbVie, Inc.
Drug name mappings:
name: 阿维巴坦钠/氨曲南
lang: CN
name: Avibactam Sodium/Aztreonam
lang: EN
Clinical trial NCT02409368: An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC
Official title: An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC
Conditions: Non-Small Cell Lung Cancer
Summary: The purpose of the study is to determine the occurrence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events in patients with advanced or metastatic Squamous Cell Non-Small Cell Lung Cancer (SqNSCLC) with progression of disease during or after at least 1 systemic therapy.
Interventions:
name: Nivolumab
type: Drug
Study arms:
design_group_description: Nivolumab IV infusion
design_group_title: Cohort A: Treatment - Nivolumab
design_group_type: Experimental
Sponsor: Bristol Myers Squibb Co.
Collaborators: Pharmaceutical Product Development LLC
Drug name mappings:
name: 纳武利尤单抗
lang: CN
name: Nivolumab
lang: EN
name: ニボルマブ（遺伝子組換え）
lang: JP
Clinical trial NCT05765500: RecoverPC: Relugolix vs GnRH Agonist in Quality of Life
Official title: RecoverPC: A Phase 2 Study of RElugolix Versus GnRH Agonist Quality of Life (QOL) and Testosterone reCOVERy in Men With Prostate Cancer
Conditions: Prostate Cancer
Prostatic Neoplasms
Summary: This study is testing the way that approved androgen deprivation therapy treatments, Leuprolide and Relugolix, for prostate cancer affect quality of life, blood levels, cholesterol, and blood sugar. The drugs are already standard treatment for people with prostate cancer, and the drugs will be used as described in their label.
The names of the study drugs involved in this study are:
* Leuprolide (type of ADT)
* Relugolix (type of ADT)
Interventions:
description: Gonadotropin-releasing hormone (GnRH) antagonist, oral tablet taken 1x daily.
name: Relugolix
other_name: Orgovyx
type: Drug
description: Gonadotropin-releasing hormone (GnRH) antagonist, intramuscular injection 1x every 3 months.
name: Leuprolide
other_name: Leuprolide Depot
type: Drug
Study arms:
design_group_description: 55 participants will be randomized in a 1:1 fashion to Relugolix and stratified by intent to treat with radiation and will complete study procedures as outlined:<br/>* Surveys at baseline and at months 3, 6, 9, and 12.<br/>* Medication diary entries.<br/>* Cycles 1 - 6:<br/>  --Days 1 - 28 of 28 day cycle: Predetermined dose of Relugolix. Participant will self-administer at home.<br/>* Follow up visits every 3 months for 12 months.
design_group_title: Arm A: Relugolix
design_group_type: Experimental
design_group_description: 55 participants will be randomized in a 1:1 fashion to Leuprolide and stratified by intent to treat with radiation and will complete study procedures as outlined:<br/>* Surveys at baseline and at months 3, 6, 9, and 12.<br/>* Cycle 1 and Cycle 4:<br/>  --Day 1 of 28 day cycle: Predetermined dose of Leuprolide. Injection will be administered in clinic.<br/>* Follow up visits every 3 months for 12 months.
design_group_title: Arm B: Leuprolide
design_group_type: Active Comparator
Sponsor: Dana-Farber Cancer Institute, Inc.
Collaborators: Pfizer Inc.
Prostate Cancer Foundation of Australia
Sumitomo Pharma Switzerland GmbH
Drug name mappings:
name: 瑞卢戈利
lang: CN
name: Relugolix
lang: EN
name: レルゴリクス
lang: JP
Clinical trial NCT01930110: Closed-loop Control of Glucose Levels (Artificial Pancreas) During Exercise in Adults With Type 1 Diabetes
Official title: An Open-label, Randomized, Cross-over Study to Compare the Efficacy of Single-hormone Closed-loop Strategy and Dual-hormone Closed-loop Strategy at Regulating Glucose Levels During Continuous Exercise and Interval Exercise in Adults With Type-1 Diabetes
Conditions: Type 1 Diabetes
Summary: Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon.
The objective is to compare the efficacy of single-hormone closed-loop strategy and dual-hormone closed-loop strategy at regulating glucose levels during continuous exercise and interval exercise.
The investigator hypothesized that dual-hormone closed-loop strategy is superior to single-hormone closed-loop strategy in regulating glucose levels during exercise periods.
Interventions:
description: Patients will be admitted at the research clinical facility at 14:30. Closed-loop strategy will start at 15:30. At 18:00, patients will performed a 60-minute exercise at 60% of VO2 max. Patients will be discharged at 20:00.
name: 60-minute exercise
type: Other
description: Patients will be admitted at the research clinical facility at 14:30. Closed-loop strategy will start at 15:30. At 18:00, patients will performed a 40-minute interval exercise. Patients will be discharged at 20:00.
name: 40-minute interval exercise
type: Other
Study arms:
design_group_description: In single-hormone closed-loop system, variable subcutaneous insulin infusion rate will be used to regulate glucose levels
design_group_title: Single-hormone closed-loop system
design_group_type: Active Comparator
design_group_description: In dual-hormone closed-loop system, variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels
design_group_title: Dual-hormone closed-loop system
design_group_type: Active Comparator
Sponsor: Institut de recherches cliniques de Montréal
Collaborators: Société Francophone Du Diabete
Drug name mappings:
name: Glucagon(Xeris Pharmaceuticals, Inc.)
lang: EN
Clinical trial NCT05401786: Anti-PD-1 Re-challenge After Immune Priming by Ipilimumab and Immune Boosting by Radiotherapy in Advanced NSCLC
Official title: Anti-PD-1 Re-challenge After Immune Priming by Ipilimumab and Immune Boosting by Radiotherapy in Advanced NSCLC
Conditions: Carcinoma, Non-Small-Cell Lung
Summary: Still many advanced non-small cell lung cancer (NSCLC) patients do not benefit from PD-(L)1 inhibition or will eventually develop progression through secondary resistance. Inhibition of CTLA-4, application of radiotherapy together with PD-1 inhibition showed synergistic effects and is deemed safe.
Interventions:
description: Anti-CTLA-4
name: Ipilimumab
type: Drug
description: PD-1 inhibition
name: Cemiplimab
type: Drug
description: Stereotactic Body Radiotherapy
name: SBRT
type: Radiation
Study arms:
design_group_description: Participants will receive 1 dose of ipilimumab (1mg/kg intravenously) on day 1. After 1 week the participants will receive SBRT (3x8Gy) on at least 1 but no more than 4 tumor lesions.<br/>Within 1 week of the last radiation fraction participants will start with cemiplimab (350mg intravenously every 3 weeks) until disease progression, unacceptable toxicity, patient request for discontinuation, or up to 2 years of treatment
design_group_title: Anti-CTLA-4, SBRT and PD1
design_group_type: Experimental
Sponsor: Netherlands Cancer Insitute
Collaborators: Genzyme Corp.
Drug name mappings:
name: 伊匹木单抗
lang: CN
name: Ipilimumab
lang: EN
name: イピリムマブ（遺伝子組換え）
lang: JP
name: 塞普利单抗
lang: CN
name: Cemiplimab-RWLC
lang: EN
name: セミプリマブ（遺伝子組換え）
lang: JP
Clinical trial NCT03614221: Comparison of Lindioil (Indigo Naturalis Oil Extract) Ointment to Protopic® Ointment 0.1% in Treating Atopic Dermatitis
Official title: Comparison of the Efficacy and Safety of Lindioil (Indigo Naturalis Oil Extract) Ointment to Protopic® (Tacrolimus 0.1%) Ointment in Treating Atopic Dermatitis: A Randomized, Evaluator-blind, Crossover, Active-Controlled Trial
Conditions: Atopic Dermatitis
Summary: The aims of this study are:
1. Compare the efficacy of Lindioil ointment and Protopic® ointment in treating atopic dermatitis.
2. Compare the safety of Lindioil ointment and Protopic® ointment in treating atopic dermatitis.
3. Compare the time to relapse after ceasing of treatment of Lindioil ointment and Protopic® ointment.
4. Compare the change of skin microbiome before and after Lindioil ointment and Protopic® ointment treatment.
Interventions:
description: Each gram contains 200µg of indirubin. Apply 0.5 g of ointment per 10 cm x 10 cm of affected skin areas twice daily for 6 weeks.
name: Lindioil ointment
other_name: Indigo naturalis oil extract ointment
type: Drug
description: Each gram contains (w/w) 0.1% of tacrolimus. Apply 0.1 g of ointment per 10 cm x 10 cm of affected skin areas twice daily for 6 weeks.
name: Protopic ointment 0.1%
other_name: Tacrolimus ointment 0.1%
type: Drug
Study arms:
design_group_description: Lindioil ointment is applied twice daily for 6 weeks, followed by a washout period of 4 days to 8 weeks depending on the results of the first treatment period and the amount of time it takes the participant to relapse to IGA ≥ 2 and less than 1-point of change from baseline1ST IGA. If relapse to IGA ≥ 2 and less than 1-point of change from baseline1ST IGA is achieved, the patient is using Protopic ointment 0.1% twice daily for another 6 weeks. If the criteria for entering the 2nd treatment are not achievable after 8-week of ceasing 1st treatment, the subject will be followed up for another 6 weeks to the end of the study
design_group_title: Lindioil
design_group_type: Experimental
design_group_description: Protopic ointment 0.1% is applied twice daily for 6 weeks, followed by a washout period of 4 days to 8 weeks depending on the results of the first treatment period and the amount of time it takes the participant to relapse to IGA ≥ 2 and less than 1-point of change from baseline1ST IGA. If relapse to IGA ≥ 2 and less than 1-point of change from baseline1ST IGA is achieved, the patient is using Lindioil ointment twice daily for another 6 weeks. If the criteria for entering the 2nd treatment are not achievable after 8-week of ceasing 1st treatment, the subject will be followed up for another 6 weeks to the end of the study
design_group_title: Protopic
design_group_type: Active Comparator
Sponsor: Chang Gung Memorial Hospital
Collaborators: Ministry of Science and Technology
Drug name mappings:
name: 他克莫司
lang: CN
name: Tacrolimus
lang: EN
name: タクロリムス水和物
lang: JP
Clinical trial NCT00901524: ANRS HC20 Effectiveness of an Optimized Anti HCV PegIFN-alpha2a + Ribavirin on Sustained Virological Response in Patients With HCV Genotype 1 and 4 Non Responders and Co-infected With HIV
Official title: ANRS HC20 Pilot Study, Multicenter, Assessing the Effectiveness of an Optimized Anti HCV (360μg/Week Induction of PegIFN-alpha2a + 18mg/kg/j of RBV for 6 Months and Then Depending on the Virological Response to S12, Elongation up S72 to the Dual Anti HCV, With Accompanying Measures) on Sustained Virological Response in Patients With HCV Genotype 1 and 4 Non Responders and Co-infected With HIV.
Conditions: Hepatitis
Summary: The purpose of this study is to assess the effectiveness of an optimized anti HCV treatment (360μg per week of PegIFN-alpha2a + 18mg/kg/j of Ribavirin for 6 months.
Interventions:
description: Pilot study, multicenter, open label
name: Peg-interféron alpha 2a + ribavirin
type: Drug
Study arms:
design_group_title: PegIFN- alpha 2a + RBV
design_group_type: No Intervention
Sponsor: France Recherche Nord & Sud SIDA HIV-Hepatites
Collaborators: Roche Pharma AG
Drug name mappings:
name: Peginterferon alfa-2a(Rhein-Minapharm)
lang: EN
name: 利巴韦林
lang: CN
name: Ribavirin
lang: EN
name: リバビリン
lang: JP