ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01756079
Conditions: Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-02-06; Completion date: 2015-11-17
Enrollment: 58 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being done to find out if the addition of boceprevir to standard of care (SOC) treatment with peginterferon alfa-2b (PegIFN-2b) + ribavirin (RBV) is effective for participants with chronic hepatitis C (CHC) genotype 1 and cirrhosis who were not successfully treated by previous SOC. All participants will receive treatment with SOC alone for 4 weeks and then boceprevir will be added to the treatment regimen for 44 additional weeks of combined treatment.

Detailed description:

Arms: arm 1: Participants will receive PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks and then will receive 44 additional weeks of treatment with PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day).
Interventions: intervention 1: boceprevir intervention 2: PegIFN-2b intervention 3: RBV
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01815515
Conditions: Metastatic Prostate Cancer
Keywords: Metastatic Prostate Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2013-03-01; Completion date: 2015-11-18
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research is being done to see if an investigational radioactive drug called 18F-DCFBC can help us find cancer that has spread (metastatic disease) from its original site in people who have cancer in their prostate to other parts of their body.

Detailed description:
The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), \[18F\]DCFBC (DCFBC) PET imaging for detection of metastatic prostate cancer. PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential. The investigators propose to assess the ability of DCFBC PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis. Correlation will be made to sites of suspected metastatic disease detected by standard conventional imaging modalities (CIM) for prostate cancer which includes IV contrast CT of chest/abdomen/pelvis and whole body bone scintigraphy.

Arms: arm 1: Participants with hormone-naive prostate cancer (HNPC) and castration-resistant prostate cancer (CRPC) with metastatic lesions detected on conventional imaging modalities (contrast-enhanced computed tomography \[CECT\] and bone scintigraphy \[BS\]) undergo PET imaging with 18F-DCFBC radiotracer.
Interventions: intervention 1: 18F-DCFBC
Intervention descriptions: intervention 1: 18F-DCFBC is a radiofluorinated small-molecule inhibitor of prostate-specific membrane antigen (PSMA).

A bolus of 10 mCi (370 MBq) \[9-11 mCi (333-407 MBq)\] of 18F-DCFBC will be injected into the IV line by slow IV push.

Protocol documents:
Clinical trial NCT01894022
Conditions: Hypertension
Keywords: Inoperable chronic thromboembolic pulmonary hypertension, endothelin receptor antagonist
Sponsor: GlaxoSmithKline
Start date: 2014-01-23; Completion date: 2015-11-18
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label, long term extension to Study AMB115811. All subjects may remain in the extension study for a minimum of 18 months. Beyond the 18-month period, subjects may continue in the extension study until one of the following: the product is approved locally for use in inoperable CTEPH patients; development for use in the CTEPH population is discontinued or product is not approved by the local regulatory authorities; or the investigator decides to discontinue the subject or subject decides to discontinue from the study. The primary purpose of this study is to provide clinically relevant information on the long term safety of ambrisentan in subjects with inoperable CTEPH.

Detailed description:

Arms: arm 1: All subjects will receive ambrisentan initially at a dose of 5 mg once daily (OD). Based on the investigator's best judgment, the subject may continue on 5 mg OD, or be up-titrated to 10 mg OD. The dose may also be adjusted back to 5 mg OD at investigator discretion.
Interventions: intervention 1: Ambrisentan 5 mg
Intervention descriptions: intervention 1: Round, white, film-coated, immediate-release tablets, containing 5 mg ambrisentan. Subjects will be dosed orally once daily. Subjects may receive 5mg, or 10 mg of ambrisentan OD.

Protocol documents:
Clinical trial NCT00953771
Conditions: Thrombotic Thrombocytopenic Purpura
Keywords: TTP Thrombotic Thrombocytopenic Purpura
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2008-10-01; Completion date: 2015-11-19
Enrollment: 9 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to find out if administration of danazol with plasma exchange and corticosteroids will reduce the number of plasma exchanges required to control Thrombotic Thrombocytopenic Purpura (TTP).

Detailed description:
Danazol is a synthetic steroid hormone structurally resembling a group of natural hormones (androgens)found in the body. Danazol has immune modifying activity and is effective in treatment of blood disorders with low platelet counts such as idiopathic thrombocytopenic purpura (however FDA has not yet approved danazol for this disorder). A study of danazol in conjunction with plasma exchange for thrombotic thrombocytopenic purpura showed that danazol decreased the number of plasma exchanges required by approximately 80% and reduced the time needed to control the disease. It's not clear how danazol works in TTP. It is not approved by the FDA for the treatment of TTP.

Arms: arm 1: Everyone will receive Danazol with plasma exchange and corticosteroids arm 2: None
Interventions: intervention 1: Danazol
Intervention descriptions: intervention 1: Danazol 600 mg PO will be initiated with plasma exchange and corticosteroids at the time of enrollment.

Protocol documents:
Clinical trial NCT01948830
Conditions: Age-related Macular Degeneration Choroidal Neovascularization
Keywords: Ranibizumab, Lucentis, choroidal neovascularization, age-related macular degeneration, treat and extend regimen
Sponsor: Novartis Pharmaceuticals
Start date: 2013-12-17; Completion date: 2015-11-19
Enrollment: 650 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to evaluate the efficacy and safety of two different regimens of 0.5 mg ranibizumab given as intravitreal injection in patients with neovascular age-related macular degeneration

Detailed description:
This was a 12-month, phase IIIb, randomized, Visual Acuity assessor-masked, multi-center, interventional study assessing the efficacy and safety of the TER vs monthly regimens of 0.5 mg ranibizumab intravitreal (IVT) injections in patients with newly diagnosed nAMD. Patients will be randomized 1:1 into one of two treatment arms, Treat and Extend or monthly regimens.

There will be 3 periods in this study: Screening period (up to 14days), treatment period (11 months), follow-up period (1 month). At randomization visit patients will be randomized into one of the 2 treatment groups Group I ranibizumab 0.5 mg based on monthly treatment or Group II ranibizumab 0.5 mg based on TER (randomization ratio of 1:1) and will receive the first dose of Investigational treatment. Patients in Group I the following visits will perform on monthly intervals. For patients in Group II the investigator will evaluate disease activity (i.e., signs of exudation) based on SD-OCT, and in case of absence of disease activity every next visit will be 2 weeks), with a maximum of a 12-week interval.

Arms: arm 1: Ranibizumab 0.5 mg/0.05 mL (Monthly regimen) up to month 11 arm 2: Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen up to month 11
Interventions: intervention 1: Ranibizumab 0.5mg intervention 2: Ranibizumab 0.5mg
Intervention descriptions: intervention 1: 0.5 mg ranibizumab (intravitreal injections) prefilled syringe) intervention 2: 0.5 mg ranibizumab (intravitreal injections) prefilled syringe)

Protocol documents:
Clinical trial NCT02513446
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2015-09-29; Completion date: 2015-11-20
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this trial is to investigate the effect of multiple doses of itraconazole on the pharmacokinetics of BI 1026706 given as single dose. The assessment of safety and tolerability of BI 1026706 is an additional objective of this trial. Furthermore, the pharmacokinetics of the metabolite BI 1072668 will be explored.

Detailed description:

Arms: arm 1: Single dose arm 2: 7 days of itraconazole treatment combined with a single dose of 1026706 on day 4
Interventions: intervention 1: BI 1026706 intervention 2: Itraconazole
Intervention descriptions: intervention 1: Single dose of BI 1026706 on Day 1 intervention 2: 7 days of itraconazole treatment combined with a single dose of BI 1026706 on the fourth day

Protocol documents:
Clinical trial NCT03179345
Conditions: Healthy
Keywords: Volunteer Pharmacodynamics Pharmacokinetics
Sponsor: Depomed
Start date: 2015-09-24; Completion date: 2015-11-20
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Phase 4, double-blind, placebo-controlled, four treatment, four sequence crossover study comparing simulated driving performance, daytime sedation and cognition in healthy volunteers administered therapeutic doses of Gralise® (Treatment A), Neurontin® (Treatment B), Lyrica® (Treatment C) and placebo (Treatment D). All doses were administered under fed conditions.

Detailed description:

Arms: arm 1: Gralise® 3 x 600 mg tablets (1800 mg total dose) administered once daily at 7:00 pm on Day 1 and Day 2 with one placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®. At other dosing times, treatment consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule. arm 2: Neurontin® 1 x 600 mg film-coated tablet administered 3 times daily at 7:00 pm on Day 1, at 8:00 am, 2:00 pm and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Neurontin® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®. arm 3: Lyrica® 1 x 150 mg capsule administered 2 times daily at 7:00 pm on Day 1, at 8:00 am and 8:00 pm on Day 2 and at 8:00 a.m. on Day 3. Each dose of Lyrica® was over-encapsulated and administered with 3 placebo tablets matching the appearance of Gralise®. arm 4: Each dose consisted of 3 placebo tablets matching the appearance of Gralise® and 1 placebo capsule matching the over-encapsulation of doses of Neurontin® and Lyrica®.
Interventions: intervention 1: Gabapentin intervention 2: Pregabalin intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02305381
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2014-12-01; Completion date: 2015-11-21
Enrollment: 397 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide once weekly versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin in subjects with type 2 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: semaglutide intervention 2: placebo
Intervention descriptions: intervention 1: Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication. intervention 2: Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.

Protocol documents:
Clinical trial NCT01775124
Conditions: Neovascular Age-related Macular Degeneration
Keywords: Macular degeneration, age-related macular degeneration (ARMD), vision loss, macula damage, retina damage, dry macular degeneration, wet macular degeneration, AMD
Sponsor: Novartis Pharmaceuticals
Start date: 2013-02-22; Completion date: 2015-11-23
Enrollment: 332 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study evaluated the efficacy and safety of two different dosing regimens of ranibizumab (either monthly injections or injections as-needed based on the stability of a patient's vision) in Chinese patients with wet age-related macular degeneration (AMD) . This study was to provide long-term safety data in the treatment of Chinese patients with wet AMD.

Detailed description:

Arms: arm 1: Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by best-corrected visual acuity (BCVA) stabilization in the extension treatment period arm 2: PRN intravitreal injections of ranibizumab 0.5 mg guided by best-corrected visual acuity (BCVA) stabilization in the 23 month treatment period
Interventions: intervention 1: Ranibizumab
Intervention descriptions: intervention 1: Intravitreal injections of 0.5 mg Ranibizumab

Protocol documents:
Clinical trial NCT01551758
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Exacerbation Adult COPD Respiratory
Sponsor: GlaxoSmithKline
Start date: 2012-03-13; Completion date: 2015-11-24
Enrollment: 2802 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to compare the effectiveness and safety of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444)) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with the existing COPD maintenance therapy over twelve months in subjects diagnosed with COPD. This is a Phase III multi-centre, randomised open label study. Subjects who meet the eligibility criteria are randomised and will enter a 12 month treatment period.

Detailed description:
This is a Phase III multi-centre, randomised open label study performed in subjects followed in primary care who have a diagnosis of and receive regular treatment for COPD in a localised geographical region of the UK

Arms: arm 1: once daily via a Novel Dry Powder Inhaler arm 2: Existing Maintenance Therapy:

* Long acting bronchodilator therapy alone
* ICS alone or in combination with a long acting bronchodilator
* Triple maintenance therapy
Interventions: intervention 1: FF/VI intervention 2: Existing Maintenance Therapy
Intervention descriptions: intervention 1: FF/VI intervention 2: Existing Maintenance Therapy:

* Long acting bronchodilator therapy alone
* ICS alone or in combination with a long acting bronchodilator
* Triple maintenance therapy

Protocol documents:
Clinical trial NCT01387594
Conditions: Crohn's Disease Ileitis Ileo-colonic and Colonic Crohn's Disease Granulomatous Colitis Regional Enteritis Ulcerative Colitis
Keywords: Crohn's disease lumbar puncture anti-MAdCAM monoclonal antibody PF-00547659 Ulcerative Colitis
Sponsor: Shire
Start date: 2012-05-03; Completion date: 2015-11-26
Enrollment: 49 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Study is designed to show a lack of effect on white blood cells circulating in the spinal fluid.

Detailed description:

Arms: arm 1: Interventions prior to treatment. Control arm arm 2: Interventions prior to and after 3 monthly injections
Interventions: intervention 1: lumbar puncture intervention 2: lumbar puncture
Intervention descriptions: intervention 1: 2 lumbar punctures prior to treatment; study drug 225mg SC once a month X 3 doses. intervention 2: 1 lumbar puncture before and after 3 doses; study drug 225mg SC once a month X 3 doses.

Protocol documents:
Clinical trial NCT01248585
Conditions: Bone Metastases
Keywords: Symptom Control
Sponsor: NCIC Clinical Trials Group
Start date: 2011-05-30; Completion date: 2015-11-27
Enrollment: 298 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research is being done because is is not known if dexamethasone can prevent pain flare (their pain temporarily gets worse before it gets better) caused by the radiation used to treat painful bone metastases. Using dexamethasone to prevent pain like this has been studied in a few people and seems promising, but it is not clear if it can decrease the pain or prevent the pain flare before it happens.

Detailed description:
Previous research has shown that for patients who receive radiation therapy to treat their painful bone metastases, about 2 out of every 5 patients (about 40%) experience pain flare. The purpose of this study is to find out whether pain flare is prevented by receiving 8mg dexamethasone at least one hour prior to radiotherapy and once daily for the following 4 days. To do this, half of the patients in this study will get dexamethasone and the other half will receive a placebo (a substance that does not do anything). Using a placebo is the best way to see if a new therapy is effective and to clearly see the potential side effects and impact on quality of life.

Arms: arm 1: 2 x 4 mg dexamethasone tablets taken once daily for 5 days arm 2: 2 placebo tablets taken once daily for 5 days
Interventions: intervention 1: Dexamethasone intervention 2: Placebo
Intervention descriptions: intervention 1: 2 x 4 mg dexamethasone (dex) tablets taken once daily for 5 days intervention 2: 2 placebo tablets taken once daily for 5 days

Protocol documents:
Clinical trial NCT01331083
Conditions: Prostate Cancer
Sponsor: NCIC Clinical Trials Group
Start date: 2011-09-09; Completion date: 2015-11-27
Enrollment: 68 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out whether the new drug PX-866 will slow the growth of your prostate cancer. The investigators will also watch you carefully for any side effects that PX-866 might cause.

Detailed description:
PX 866 is a new type of drug that inhibits a molecule related to cancer cell growth. While this molecule is also found in normal cells, it is much more active in some cancer cells, so inhibiting the molecule with PX-866 is hoped to slow the growth of cancer cells. Laboratory tests show that it may help slow the growth of prostate cancer in animals, but it is not known whether it will have the same effects in humans. PX-866 has been studied in some cancer patients to find out safe doses that can be given but it has not undergone study in prostate cancer. This study will be the first study of PX-866 in prostate cancer.

Health Canada has not approved the sale or use of PX-866 to treat prostate cancer, although they have approved its use in this clinical trial.

Arms: arm 1: None
Interventions: intervention 1: PX-866
Intervention descriptions: intervention 1: PX-866: 8mg orally taken daily

Protocol documents:
Clinical trial NCT00614523
Conditions: MDS Myelodysplastic Syndromes Thrombocytopenia
Keywords: MDS Low Risk MDS Intermediate-1 Risk MDS Thrombocytopenia
Sponsor: Amgen
Start date: 2008-07-21; Completion date: 2015-11-30
Enrollment: 250 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Data Monitoring Committee (DMC) for study 20060198 recommended that all subjects discontinue treatment of study drug and continue to be followed for long term follow-up. Amgen adopted the DMC recommendation.

Detailed description:
This is a Phase 2, multicenter, randomized, double blind, placebo controlled study designed to assess the efficacy and safety of romiplostim (formerly, AMG 531) treatment in thrombocytopenic MDS patients. The study is composed of a 26-week placebo controlled test treatment period (romiplostim versus Placebo), a 4 week interim wash-out period, a 24-week placebo controlled extended treatment period, and a 4-week follow-up period followed by an End of Study (EOS) visit. During the interim wash-out period, a bone marrow biopsy will be performed in the absence of growth factor to assess changes in the marrow. In the extended treatment period, safety assessments will continue and participants will be allowed to receive any standard of care treatments for MDS. Patients will be followed for survival for an additional 60 months following the End of Study (EOS) visit.

Arms: arm 1: Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg. arm 2: Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
Interventions: intervention 1: Placebo intervention 2: Romiplostim
Intervention descriptions: intervention 1: Placebo is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder. intervention 2: Romiplostim is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.

Protocol documents:
Clinical trial NCT00481247
Conditions: Myeloid Leukemia, Chronic
Keywords: Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia
Sponsor: Bristol-Myers Squibb
Start date: 2007-09-01; Completion date: 2015-12-01
Enrollment: 547 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to compare the confirmed complete cytogenetic response of dasatinib with that of imatinib within 12 months after randomization in patients with newly diagnosed chronic-phase Philadelphia positive chronic myeloid leukemia. The safety of this treatment will also be studied.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dasatinib intervention 2: Imatinib
Intervention descriptions: intervention 1: Tablets, oral, dasatinib 50-140 mg once daily (QD) intervention 2: Tablets, oral, imatinib 200-800 mg, QD

Protocol documents: