ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT03840993
Conditions: Endometrial Related Pain
Keywords: Endometriosis
Sponsor: Mitsubishi Tanabe Pharma America Inc.
Start date: 2019-01-15; Completion date: 2021-10-05
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and efficacy of MT-2990 for treatment of moderate to severe endometriosis-related pain in women with surgically diagnosed endometriosis.

Detailed description:

Arms: arm 1: MT-2990, over 16 weeks arm 2: Placebo, over 16 weeks
Interventions: intervention 1: MT-2990 intervention 2: Placebo
Intervention descriptions: intervention 1: over 16 weeks intervention 2: over 16 weeks

Protocol documents:
Prot_000.pdf: 















































































































































































































SAP_001.pdf:
Clinical trial NCT04165824
Conditions: ALS
Sponsor: Mitsubishi Tanabe Pharma America Inc.
Start date: 2019-11-18; Completion date: 2021-10-07
Enrollment: 185 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) over 24 and 48 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: MT-1186
Intervention descriptions: intervention 1: * An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug free period
* Subsequent treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period. Treatment cycles are every 4 weeks.

Protocol documents:
Prot_000.pdf: 





















































































































































SAP_001.pdf:
Clinical trial NCT04523129
Conditions: Dry Eye Disease
Sponsor: Novaliq GmbH
Start date: 2020-12-05; Completion date: 2021-10-08
Enrollment: 834 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this pivotal trial is to assess the efficacy, safety and tolerability of CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye Disease (DED).

Detailed description:
This Phase 3 study will assess the efficacy, safety and tolerability of CyclASol 0.1% Ophthalmic Solution administered bilaterally twice daily versus vehicle.

Arms: arm 1: Cyclosporine A solution in vehicle arm 2: Vehicle only
Interventions: intervention 1: CyclASol topical ocular, eye drops intervention 2: Vehicle topical ocular, eye drops
Intervention descriptions: intervention 1: Cyclosporine A solution in vehicle intervention 2: Vehicle

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT03686397
Conditions: Otomycosis
Sponsor: Salvat
Start date: 2020-06-09; Completion date: 2021-10-19
Enrollment: 194 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multicenter, randomized, 2-arm parallel-group, double blind, placebo-controlled study in patients suffering from Otomycosis. This study will compare the efficacy and safety of SVT-15652 otic solution to that of Placebo, when administering one vial twice daily during 14 days.

Detailed description:

Arms: arm 1: 1 vial twice daily arm 2: 1 vial twice daily
Interventions: intervention 1: SVT-15652 intervention 2: Placebo
Intervention descriptions: intervention 1: 1 vial twice daily intervention 2: 1 vial twice daily

Protocol documents:
Prot_000.pdf: 
 
 


 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 


 
 
 
 
 


 
 
 
 
 


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
  
 
 
 


 
 
 
 
 
 
 
 


 
 
 
 


 
 
 
 


 
 
 
 


 
 
 
 
 


 
 
 
 
 
 
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SAP_001.pdf:
Clinical trial NCT03686384
Conditions: Otomycosis
Sponsor: Salvat
Start date: 2020-02-27; Completion date: 2021-10-25
Enrollment: 217 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multicenter, randomized, 2-arm parallel-group, double blind, placebo-controlled study in patients suffering from Otomycosis. This study will compare the efficacy and safety of SVT-15652 otic solution to that of Placebo, when administering one vial twice daily during 14 days.

Detailed description:

Arms: arm 1: 1 vial twice daily arm 2: 1 vial twice daily
Interventions: intervention 1: SVT-15652 intervention 2: Placebo
Intervention descriptions: intervention 1: 1 vial twice daily intervention 2: 1 vial twice daily

Protocol documents:
Prot_000.pdf: 
 
 


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 


 
 
 
 
 


 
 
 
 
 


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
  
 
 
 


 
 
 
 
 
 
 
 


 
 
 
 


 
 
 
 


 
 
 
 


 
 
 
 
 


 
 
 
 
 
 
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SAP_001.pdf:
Clinical trial NCT03228186
Conditions: Non-small Cell Lung Cancer
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2018-03-05; Completion date: 2021-11-04
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is a single institution Phase II single arm trial to assess the efficacy of the combination of pevonedistat plus docetaxel in patients with previously treated advanced NSCLC (non-small cell lung cancer).

Detailed description:

Arms: arm 1: Pevonedistat 25mg/m2 days 1, 3, 5 Docetaxel 75mg/m2 day 1 21 day cycle
Interventions: intervention 1: Pevonedistat intervention 2: Docetaxel
Intervention descriptions: intervention 1: 25mg/m2 days 1, 3, 5 intervention 2: 75mg/m2 day 1

Protocol documents:
Prot_SAP_ICF_000.pdf:
Clinical trial NCT02387996
Conditions: Various Advanced Cancer
Sponsor: Bristol-Myers Squibb
Start date: 2015-03-09; Completion date: 2021-11-12
Enrollment: 270 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose the study is to measure the effect of nivolumab (BMS-936558) in reducing tumor size in subjects with metastatic or unresectable bladder cancer.

Detailed description:

Arms: arm 1: Nivolumab intravenous infusion as specified
Interventions: intervention 1: Nivolumab
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02517918
Conditions: Solid Tumor Osteosarcoma
Keywords: Advanced solid tumor Bone metastasis and advanced pretreated osteosarcoma Phase I trial Dose escalation and expansion cohort Biomarkers study
Sponsor: Institut Bergonié
Start date: 2015-02-01; Completion date: 2021-11-16
Enrollment: 23 participants; Allocation: NA; Intervention model: SEQUENTIAL

Brief summary:
This is a prospective open-labeled phase I trial based on a dose escalating study design assessing two dose levels of sirolimus when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) followed by an expansion cohort once the Maximum Tolerated Dose (MTD) is established.

Detailed description:
The dose escalation part of the trial will be concerned on adults with advanced solid tumor with bone metastasis and young and adult patients with unresectable locally advanced or metastatic osteosarcoma.

The Expansion cohort will be conducted on young and adult patients with unresectable locally advanced or metastatic osteosarcoma.

Arms: arm 1: Drug : Metronomic Cyclophosphamide, Methotrexate, Sirolimus, Zoledronic acid Assessment of the maximum tolerated dose of sirolimus Cyclophosphamide, Methotrexate and Sirolimus will be administrated orally. Zoledronic Acid will be administrated by infusion (IV).
Interventions: intervention 1: Sirolimus combined with CP, MT and ZA
Intervention descriptions: intervention 1: Cyclophosphamide, Methotrexate and Sirolimus will be administrated orally. Zoledronic Acid will be administrated by infusion (IV).

Trial based on a dose escalating study design assessing two dose levels of sirolimus when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) followed by an expansion cohort once the MTD is established.

Protocol documents:
Clinical trial NCT00281658
Conditions: Neoplasms, Breast
Keywords: ErbB2 positive human epidermal growth factor receptor 2 positive (Her2+) metastatic breast cancer Fluorescence in situ hybridization (FISH) positive Stage IV
Sponsor: Novartis Pharmaceuticals
Start date: 2006-01-02; Completion date: 2021-11-23
Enrollment: 444 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a randomized, double-blind, placebo-controlled, multicenter, Phase III study to evaluate and compare the efficacy and safety of Lapatinib + Paclitaxel versus Placebo + Paclitaxel in men and women with ErbB2 amplified metastatic (Stage IV) breast cancer who had not received prior therapy for metastatic disease.

Detailed description:
Subjects were randomized to receive either Lapatinib (1500 mg once daily) + Paclitaxel (80 mg/m2 IV weekly for 3 weeks every 4 weeks) or Placebo (once daily) + Paclitaxel (80 mg/m2 IV weekly for 3 weeks every 4 weeks).

Subjects who progressed while on study and were on the placebo+paclitaxel arm were permitted to enter an extension phase of open label monotherapy therapy with lapatinib or open label combination therapy with lapatinib+paclitaxel and followed for response, progression and survival.

Based on the positive results in the primary analysis, Protocol Amendment 02 (dated 09 May 2011) discontinued further entry into the lapatinib monotherapy extension phase, and ongoing subjects taking placebo were permitted to replace it with open label lapatinib therapy (with or without continued paclitaxel therapy).

Following the primary Overall Survival (OS) analysis and subsequent implementation of Protocol Amendment 03, subjects who were still receiving active treatment entered the Long-term follow-up (LTFU) phase of the study. Reporting requirements in the LTFU phase were limited to Adverse events of special interest (AESI), Serious adverse events (SAEs) and pregnancy, and the subjects continued to receive treatment until the occurrence of unacceptable toxicity or disease progression (as determined by the investigator) or permanent withdrawal from treatment for any reason. Subjects who were no longer receiving active treatment were withdrawn from the study.

Arms: arm 1: Paclitaxel and Lapatinib (Blinded) arm 2: Paclitaxel and Placebo (Blinded) arm 3: Open Label - Monotherapy (Lapatinib) arm 4: Open Label - Combination Therapy (Lapatinib and Paclitaxel)
Interventions: intervention 1: Lapatinib (GW572016) oral tablets intervention 2: Paclitaxel infusion intervention 3: Placebo
Intervention descriptions: intervention 1: 1500 mg oral daily continuously intervention 2: Paclitaxel 80 mg/m2 every 3 weeks, 4th week rest for minimum 6 months intervention 3: Paclitaxel Matching Placebo

Protocol documents:
Clinical trial NCT00537095
Conditions: Thyroid Neoplasms
Keywords: follicular papillary
Sponsor: Genzyme, a Sanofi Company
Start date: 2007-09-28; Completion date: 2021-11-24
Enrollment: 164 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a parallel group, randomized, double blind, placebo controlled, multicentre study designed to assess whether vandetanib (ZD6474) conferred an improvement in PFS as compared to placebo in participants with locally advanced or metastatic papillary or follicular thyroid carcinoma failing or unsuitable for radioiodine therapy. The trial was of a sufficient size so that if vandetanib (ZD6474) was truly active there was a high probability that it would demonstrate an effect sufficiently promising to warrant a follow-up assessment.

* Participants were seen weekly for the first 2 weeks, then again at Week 4, Week 8, and Week 12 after randomization, and every 12 weeks thereafter. Upon disease progression, all participants (both active and placebo) were unblinded and given the option to discontinue blinded study treatment and enter follow up and survival, or begin open label vandetanib (ZD6474) 300 mg treatment. All participants were followed to collect survival data until greater than or equal to (\>=) 50% of participants had died. Participants who were taking vandetanib (ZD6474) at the time of study closure and wished to remain on therapy were allowed to continue for as long as the Investigator felt that they were obtaining clinical benefit, or until they were given another anti-cancer therapy. The safety data from all participants was assessed on an ongoing basis, including discontinuation and follow up.
* Radiologic evaluation using RECIST criteria was performed every 12 weeks (+/- 2 weeks). All medical images were centralized assessed at the site and centrally reviewed. Participants were evaluated until progression, and then followed up for survival, regardless of whether they continued randomized treatment, unless they withdrew consent. Post progression open-label vandetanib (ZD6474) were offered at the investigators discretion.
* All participants submitted a suitable archived tumor sample prior to randomization. In the event that a suitable archived sample was not available within 2 weeks prior to randomization, a fresh tumor sample was obtained in its place prior to randomization. If a participant underwent the fresh tumor biopsy procedure, this specimen would satisfy the first optional tumor biopsy submission should they consented to the exploratory part of the study.

Detailed description:

Arms: arm 1: vandetanib (ZD6474) 300 mg per os once daily arm 2: Placebo
Interventions: intervention 1: Vandetanib intervention 2: Placebo
Intervention descriptions: intervention 1: 300 mg oral once daily oral dose intervention 2: None

Protocol documents: