ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01073865
Conditions: Breast Cancer
Keywords: ZOLADEX Pre-menopausal Oestrogen Receptor Advanced Breast Cancer Progression Free Survival
Sponsor: AstraZeneca
Start date: 2010-02-26; Completion date: 2017-11-20
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the efficacy and safety as well as the characteristics of the female hormone and study medications after administration in pre-menopausal women with estrogen receptor positive advanced breast cancer who were randomised in a 1:1 ratio to either of the two treatment groups; the ZD9393 3.6 mg depot group or ZD9393 10.8 mg depot group, both given in combination with tamoxifen tablets.

Detailed description:

Arms: arm 1: Zoladex 10.8 mg (goserelin acetate) will be injected once every 12 weeks (± 7 days).

One oral tamoxifen 20 mg tablet also will be taken daily arm 2: Zoladex 3.6 mg (goserelin acetate) will be injected once every 4 weeks (± 7 days). One oral tamoxifen 20 mg tablet will also be taken daily.
Interventions: intervention 1: ZD9393 (Zoladex) 10.8 mg intervention 2: ZD9393 (Zoladex) 3.6 mg
Intervention descriptions: intervention 1: 10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days). intervention 2: 3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days).

Protocol documents:
Clinical trial NCT01663727
Conditions: Metastatic Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2012-08-27; Completion date: 2017-11-21
Enrollment: 481 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast cancer. Patients will be randomized to one of two treatment arms: bevacizumab or placebo. All patients will be given an intravenous (IV) infusion of of paclitaxel (90 mg/m2) for 3 weeks during each 28-day cycle. bevacizumab or placebo (10 mg/kg) will be administered by IV infusion on Days 1 and 15 of each 28-day cycle. Patients will be treated until disease progression, unacceptable toxicity or death from any cause occurs.

Detailed description:

Arms: arm 1: Paclitaxel + Bevacizumab \[Avastin\] arm 2: Paclitaxel + Placebo
Interventions: intervention 1: Bevacizumab [Avastin] intervention 2: Paclitaxel intervention 3: Placebo
Intervention descriptions: intervention 1: Intravenous repeating dose intervention 2: Intravenous repeating dose intervention 3: Intravenous repeating dose

Protocol documents:
Clinical trial NCT02374099
Conditions: Breast Neoplasms
Keywords: Breast Cancer Her2 - ER+ CC-486 (ORAL AZACITIDINE) Metastatic Breast Cancer Oral Azacitidine Fulvestrant Epigenetics
Sponsor: Celgene
Start date: 2015-03-13; Completion date: 2017-11-21
Enrollment: 97 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant in Postmenopausal Women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 (HER2-) Metastatic Breast Cancer Who Have Progressed on an Aromatase Inhibitor (AI).

Detailed description:
This is a Phase 2, open-label, two-arm study assessing the efficacy and safety of the combination of fulvestrant with CC-486 in subjects with ER+, HER2- metastatic breast cancer who have progressed after prior AI.

Approximately 92 participants will be enrolled and assigned randomly in a 1:1 ratio to one of two treatment arms:

* Arm A: CC-486 300 mg and fulvestrant 500 mg: 46 subjects
* Arm B: Fulvestrant 500 mg: 46 subjects Each cycle will be 28 days. CC-486 will be administered orally at a dose of 300 mg daily on days 1-21 of each 28-day cycle. Fulvestrant will be administered by intramuscular (IM) injection at a dose of 500 mg on days 1 and 15 of cycle 1 and day 1 of subsequent cycles.

Safety will be evaluated by an independent data monitoring committee (DMC) after a total of approximately 32 subjects have completed at least 1 treatment cycle.

Arms: arm 1: CC-486 300 mg by mouth (PO) daily on days 1-21 of each 28 day cycle and fulvestrant 500mg by intramuscular (IM) injection on Days 1 and 15 of cycle 1 and day 1 of each subsequent cycle every 28 days. arm 2: Fulvestrant will be administered by intramuscular injection at a dose of 500 mg on days 1 and 15 of cycle 1 and day 1 of subsequent cycles.
Interventions: intervention 1: CC-486 intervention 2: Fulvestrant
Intervention descriptions: intervention 1: Each cycle will be 28 days. CC-486 will be administered orally at a dose of 300 mg daily on days 1-21 of each 28-day cycle intervention 2: Fulvestrant will be administered by intramuscular (IM) injection at a dose of 500 mg on days 1 and 15 of cycle 1 and day 1 of subsequent cycles.

Protocol documents:
Clinical trial NCT01951586
Conditions: Non-Small Cell Lung Cancer
Sponsor: Amgen
Start date: 2013-12-31; Completion date: 2017-11-28
Enrollment: 226 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase 2 trial is studying the effect of adding denosumab to standard chemotherapy in the treatment of advanced lung cancer.

Detailed description:
This is a global randomized double-blind placebo-controlled study in patients with Stage IV untreated non-small cell lung cancer (NSCLC) with or without bone metastasis. Eligible participants are to receive 4 to 6 cycles of a standard of care platinum-doublet chemotherapy regimen. Participants will be randomized in a 2:1 ratio to receive denosumab or matching placebo with the first investigational product dose coinciding with participant's first cycle of chemotherapy and continuing until the primary analysis, unacceptable toxicity, withdrawal of consent, death, or lost to follow-up. Participants who discontinued the investigational product early (ie, before primary analysis) were followed for disease status and survival. The primary analysis took place when 149 events of death had been reported. All participants were followed for 2 years after the last dose of blinded investigational product.

Arms: arm 1: Participants received placebo matching to denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants with bone metastases also received 4 mg zoledronic acid administered as an IV infusion Q4W or Q3W. arm 2: Participants received 120 mg denosumab by subcutaneous injection once every 4 weeks plus one loading dose on study day 8 in addition to platinum-based standard chemotherapy. Participants with bone metastases also received placebo to zoledronic acid administered as an IV infusion Q4W or Q3W.
Interventions: intervention 1: Denosumab intervention 2: Zoledronic acid intervention 3: Placebo to Denosumab intervention 4: Standard Chemotherapy intervention 5: Placebo to Zoledronic Acid
Intervention descriptions: intervention 1: Administered by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8; could be administered as often as every 3 weeks (Q3W) to participants receiving Q3W chemotherapy. intervention 2: Administered by intravenous infusion in participants with bone metastasis upon investigative site request for IV bone-targeted therapy. intervention 3: Administered by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8; could be administered as often as every 3 weeks (Q3W) to participants receiving Q3W chemotherapy. intervention 4: Standard of care chemotherapy consisting of pemetrexed or gemcitabine in combination with cisplatin or carboplatin administered according to local practice. intervention 5: Administered by intravenous infusion in participants with bone metastasis upon investigative site request for IV bone-targeted therapy.

Protocol documents:
Clinical trial NCT00446446
Conditions: Cancer Carcinoma Head and Neck Cancer Metastases Metastatic Cancer Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck Oncology Squamous Cell Carcinoma Tumors
Sponsor: Amgen
Start date: 2007-10-30; Completion date: 2017-11-29
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To estimate the effect of second-line panitumumab monotherapy on objective response in patients with metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN).

Detailed description:

Arms: arm 1: articipants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
Interventions: intervention 1: Panitumumab
Intervention descriptions: intervention 1: Panitumumab was administered over a 1 hour intraveneous (IV) infusion at a dose of 9 mg/kg every 21 days.

Protocol documents:
Clinical trial NCT01936363
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer Pimasertib Placebo SAR245409
Sponsor: EMD Serono
Start date: 2013-09-30; Completion date: 2017-11-30
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double blind, randomized, placebo-controlled, 2-arm, Phase 2 trial investigating the efficacy and safety of combination therapy of pimasertib plus SAR245409 and pimasertib placebo administered once per day compared to pimasertib administered twice per day plus SAR245409 placebo administered once per day in participants with previously treated unresectable low-grade serous ovarian or peritoneal carcinoma or serous borderline ovarian or peritoneal tumors.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pimasertib once daily intervention 2: Pimasertib placebo intervention 3: SAR245409 placebo intervention 4: SAR245409 intervention 5: Pimasertib twice daily
Intervention descriptions: intervention 1: Pimasertib administered as oral capsule at a dose of 60 milligram (mg) once daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. intervention 2: Placebo matching Pimasertib administered once daily in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. intervention 3: Placebo matching SAR245409 administered once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. intervention 4: SAR245409 administered as oral capsule at a dose of 70 milligram (mg) once daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first. intervention 5: Pimasertib administered as oral capsule at a dose of 60 milligram (mg) twice daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.

Protocol documents:
Clinical trial NCT01847014
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial Hypertension (PAH) psychometric instrument PAH-SYMPACT
Sponsor: Actelion
Start date: 2013-09-01; Completion date: 2017-11-30
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401 study.

Detailed description:

Arms: arm 1: Macitentan tablet, dose of 10 mg, once daily.
Interventions: intervention 1: Macitentan
Intervention descriptions: intervention 1: Macitentan tablet, dose of 10 mg, once daily.

Protocol documents:
Clinical trial NCT00570258
Conditions: Metastatic Breast Cancer
Sponsor: University of Arkansas
Start date: 2006-09-01; Completion date: 2017-12-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, double-blind study of fulvestrant plus erlotinib versus fulvestrant plus placebo for subjects with metastatic breast cancer whose disease progression after first line hormonal therapy.

1. To obtain preliminary estimates of the magnitude and variability of the efficacy of fulvestrant in combination with erlotinib in this subject population, and
2. To obtain historically up-to-date estimates of the magnitude and variability of the efficacy of fulvestrant as the sole active agent in this subject population.

The measure of efficacy for both primary objectives will be time to progression.

Detailed description:
This is a multicenter, randomized, double-blind study of fulvestrant plus erlotinib versus fulvestrant plus placebo for subjects with metastatic breast cancer whose disease progressed after first line hormonal therapy.

* Total number of subjects planned for the trial is 130 subjects, that is, approximately 65 subjects in each arm.
* Subjects will be randomized to receive fulvestrant/erlotinib (arm A) or fulvestrant/placebo (arm B) and stratified based on accrual center.
* The study is a parallel-arm double-blind study, with fulvestrant + placebo on the monotherapy arm, and fulvestrant + erlotinib on the combination arm.
* The primary variable outcome is time to progression.
* Subjects whose metastatic disease was diagnosed more than 12 months after completing adjuvant hormonal therapy are eligible to this study if their breast cancer is hormone-receptor-positive and after disease progression on first line hormonal therapy in the metastatic setting. Subjects may have received no more than one line of chemotherapy. While receiving one line of hormonal therapy in the metastatic setting is a requirement, receiving chemotherapy is not, and one line of chemotherapy in the metastatic setting would not exclude these subjects from the trial. Subjects who had a recurrence while on adjuvant hormonal treatment or within 12 months of completion of the adjuvant hormonal treatment are also eligible without the need to receive first line hormonal therapy in the metastatic setting.

Arms: arm 1: Fulvestrant: 250 mg IM Q 4 weeks

Placebo: 150 mg PO QD arm 2: Fulvestrant: 250 mg IM Q 4 weeks

Erlotinib: 150 mg PO QD
Interventions: intervention 1: Fulvestrant intervention 2: erlotinib intervention 3: Fulvestrant intervention 4: Placebo
Intervention descriptions: intervention 1: Fulvestrant: 250 mg IM Q 4 weeks intervention 2: 150 mg PO QD intervention 3: 250 mg IM Q 4 weeks intervention 4: Placebo 150 mg PO QD

Protocol documents:
Clinical trial NCT01484041
Conditions: Breast Cancer
Keywords: Breast cancer postmenopausal
Sponsor: Georgetown University
Start date: 2012-04-01; Completion date: 2017-12-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is for women with confirmed hormone receptor positive HER-2 negative advanced breast cancer with evidence of disease resistance to an aromatase inhibitor.

The purpose of this study is to determine how well these medications work together and/or if they have any side effects in patients with hormone-receptor positive metastatic breast cancer who have demonstrated progression of disease after first line hormonal therapy.

This research is being done to determine if taking an already approved medicine (aromatase inhibitor) in combination with a new medication (dovitinib) results in better outcomes for patients with this disease.

Both dovitinib and an aromatase inhibitor are pills that will be taken at home.

Detailed description:
This is a Phase I/Phase II open-label single arm trial of dovitinib in combination with anastrozole 1 mg daily, exemestane 25 mg daily, or letrozole 2.5 mg daily. Study subjects will receive the aromatase inhibitor on which they had previously derived clinical benefit.

Arms: arm 1: Dovitinib with aromatase inhibitor
Interventions: intervention 1: Dovitinib intervention 2: Aromatase Inhibitors
Intervention descriptions: intervention 1: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest intervention 2: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily

Protocol documents:
Clinical trial NCT01647958
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: TEMPO TIF Transoral Incisionless Fundoplication EsophyX System refractory symptoms proton pump inhibitors EndoGastric Solutions EGS Acid Reflux Heartburn Regurgitation
Sponsor: EndoGastric Solutions
Start date: 2012-06-01; Completion date: 2017-12-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the efficacy and safety of Transoral Incisionless Fundoplication (TIF) performed with EsophyX as compared to proton pump inhibitor (PPI) therapy for the treatment of chronic Gastroesophageal Reflux Disease (GERD) patients with refractory symptoms on Proton Pump Inhibitors (PPIs).

Detailed description:
The objective of this study is to assess the efficacy and safety of TIF performed with EsophyX as compared to proton pump inhibitor (PPI) therapy for the treatment of chronic GERD patients with medically refractory GERD symptoms other than heartburn.

Primary hypothesis: TIF will be superior to PPIs in eliminating or significantly improving daily bothersome GERD symptoms and/or troublesome regurgitation, if present, at 6-month follow-up. Secondary hypotheses: TIF will be superior to PPIs in eliminating or significantly improving daily bothersome GERD symptoms and/or troublesome regurgitation, if present, at 12-, 24-, 36-, 48- and 60-month follow-up. The majority of surgical patients will have normalized or 50% improved esophageal acid exposure compared to baseline at 6-month follow-up. The majority of surgical patients will be completely off PPIs at 6-, 12-, 24-, 36-, 48- and 60-month follow-up compared to baseline. The majority of crossover patients will be completely off PPIs at 6-, 18-, 30-, 42- and 54-month follow-up compared to baseline. A statistically greater proportion of crossover patients treated with TIF will be free of daily bothersome symptom(s) or will experience clinically significant improvement at 6-, 18-, 30-, 42- and 54-month follow-up.

Arms: arm 1: Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol. arm 2: Patients who are dependent upon daily PPIs will continue on single dose twice daily or increase to single dose twice daily for the first six months of the clinical trial. Patients will be offered TIF crossover procedure upon completion of month-6 follow-up visit.
Interventions: intervention 1: EsophyX System with SerosaFuse fasteners intervention 2: PPI
Intervention descriptions: intervention 1: Transoral Incisionless Fundoplication (TIF)/Transoral incisionless esophago-gastric fundoplication using the EsophyX System with SerosaFuse fasteners intervention 2: Control Arm participants will take maximum standard dose of PPI during Initial Study period

Protocol documents:
Clinical trial NCT01686828
Conditions: Insulin Resistance Type 2 Diabetes Mellitus Obesity Androgen Deficiency Metabolic Disease
Keywords: insulin androgens insulin resistance testosterone estradiol obesity
Sponsor: University of Washington
Start date: 2013-06-01; Completion date: 2017-12-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to understand the effects of testosterone and estrogen on the body's response to the hormone insulin.

Detailed description:
The investigators will examine the effects of testosterone on insulin sensitivity and body composition in men. This study may lend greater insight into the increased risk of diabetes evident in men with low circulating levels of testosterone. Three drugs will be used in this study: acyline, given by injection; testosterone (T) gel that is applied to the skin; and letrozole, which is an oral drug that blocks the conversion of androgens (male hormones) to estrogens (female hormones). Acyline inhibits the production of luteinizing hormone (LH) and follicle stimulating hormone (FSH). When acyline stops the production of these hormones, it blocks the signal from the brain that stimulates the testicles to make testosterone. Adding testosterone to acyline will restore physiologic levels of testosterone in some study participants. One group of men will receive T gel with letrozole, an aromatase inhibitor; these men will have normal levels of testosterone but low levels of estrogen in the blood. This design will enable determination of the respective metabolic effects of testosterone and estrogen.

Arms: arm 1: Acyline (300mcg/kg) + placebo transdermal gel + placebo pill daily arm 2: Acyline (300mcg/kg) + Testosterone gel (1.25g) daily + placebo pill daily arm 3: Acyline (300mcg/kg) + Testosterone gel (5g) daily + placebo pill daily arm 4: Acyline (300mcg/kg) + Testosterone gel (5g) daily + letrozole (5mg) daily
Interventions: intervention 1: Acyline intervention 2: Testosterone 1.62% gel intervention 3: Letrozole intervention 4: Placebo gel (for Testosterone 1.62% gel) intervention 5: Placebo pill (for Letrozole)
Intervention descriptions: intervention 1: 300 mcg/mL administered subcutaneously (at Day 0, Week 2) intervention 2: Transdermal Testosterone Gel (either 1.25g or 5g/d) for 4 weeks intervention 3: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks intervention 4: placebo gel manufactured to mimic Testosterone 1.62% gel intervention 5: Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d

Protocol documents: