ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01744782
Conditions: Cystinosis
Keywords: Nephropathic Cystinosis Cysteamine Delayed-release Cysteamine CTNS Protein, Human Orphan Disease
Sponsor: Amgen
Start date: 2012-12-20; Completion date: 2016-12-13
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a long-term, open-label study of the safety, tolerability and effectiveness of RP103 in cystinosis patients who were naïve to any form of cysteamine treatment. Participants received RP103 treatment for at least 12 months. U.S. participants transitioned to the commercially approved drug PROCYSBI®. In Brazil, after at least 12 months of study participation and upon approval by the Brazilian regulatory authorities, participants were eligible to transition to a post-study drug supply program, and continue to receive the drug at no personal cost.

Detailed description:
The purpose of this study was to gather information about the safety and effectiveness (how well it works to treat cystinosis) of a new drug called RP103.

In cystinosis, the body builds up cystine. When taken regularly, the active ingredient of an older, already approved drug called Cystagon® (cysteamine bitartrate) reduces cystine in the body. RP103 has the same active ingredient as Cystagon® and is designed to reduce cystine in a similar way that Cystagon® does. RP103 is also different from Cystagon®: Instead of the cysteamine bitartrate being absorbed from the stomach, RP103 is designed to be absorbed from the small intestine. This may make the effects of the drug last longer, so that it can be taken twice a day instead of four times a day like Cystagon®.

To decide if RP103 is effective, the study used two types of blood tests. One test is pharmacodynamics (PD), which measures the amount of white blood cell (WBC) cystine after taking study drug. WBC cystine is a laboratory test used to find out if cysteamine bitartrate is reducing cystine levels in the body. The second test is pharmacokinetics (PK), which measures the amount of cysteamine in the blood after taking the drug.

Study with completed results acquired from Horizon in 2024.

Arms: arm 1: From Day 1 and throughout the duration of participation, RP103 (Cysteamine Bitartrate Delayed-release Capsules) was administered every 12 hours (Q12H), supplied as 75 mg and 25 mg capsules.
Interventions: intervention 1: RP103
Intervention descriptions: intervention 1: Cysteamine Bitartrate Delayed-release Capsules (RP103) were administered twice daily, orally or via gastrostomy tube (G-tube), after a 2-hour fast. The starting dose was one-quarter of the RP103 targeted maintenance dose based on age, weight, and body surface area. The recommended targeted maintenance dose for children up to 6 years old was 1 gram/m²/day, in 2 divided doses given Q12H. The dose was gradually escalated, in 10% steps, based on monitoring of WBC cystine levels 30 minutes after the morning RP103 dose collected every 2 weeks, until the participant's WBC cystine level was \<1 nmol ½ cystine/mg protein.

Protocol documents:
Clinical trial NCT02015754
Conditions: Colorectal Cancer
Sponsor: Yale University
Start date: 2014-02-01; Completion date: 2016-12-13
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Purpose:

The purpose of this study is to determine the feasibility and safety of using small beads (70-150 micron in place of 100-300 micron) to deliver chemotherapy into the liver to treat patients with liver lesions from colorectal cancer. The beads (LC-Bead M1) will be loaded with irinotecan (DEBIRI-M1), and used to administer transarterial chemoembolization (TACE).

Eligibility:

Patients with liver cancer from colorectal cancer.

Study Overview/ Treatment:

DEBIRI, loaded with irinotecan, is a device that utilizes tiny beads (70-150 microns) to deliver chemotherapy agents into liver tumor(s) via the hepatic artery. This device allows for continuous release of irinotecan into the liver tumor tissue(s) causing necrosis of the targeted tumor(s). The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. Response to therapy will be evaluated monthly by clinic visits and blood tests (to include assessment of liver function and tumor markers) and by imaging (usually MRIs) every 1-2 months. Patients will be on study for 6 months after which they will be exited from the study and followed for survival. Once exited from the study they will continue to be eligible to receive DEBIRI, should it be recommended.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: DEBIRI intervention 2: LC Bead M1 intervention 3: TACE
Intervention descriptions: intervention 1: Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor. intervention 2: The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer. intervention 3: TACE a minimally invasive procedure performed to restrict a tumor's blood supply.

Protocol documents:
Clinical trial NCT01714726
Conditions: Crohn's Disease
Keywords: MEDI2070 inflammatory bowel disease moderate to severe Crohn's disease
Sponsor: AstraZeneca
Start date: 2013-02-01; Completion date: 2016-12-14
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to evaluate the clinical efficacy and safety of MEDI2070 as compared to placebo. Investigational product will be administered as intravenous infusion in double-blind period, and as a subcutaneous injection in open-label period

Detailed description:
This is a two-part Phase 2a study compromising a 12-week, double-blind, placebo-controlled, treatment period followed by a 100-week, open label, treatment period to evaluate short-term efficacy, and the short- and long-term safety of MEDI2070 in subjects with moderate to severe, active CD who have failed or are intolerant to anti-TNFα therapy as determined by the investigator. Approximately 120 subjects will be randomized in a 1:1 ratio to initially receive a fixed IV dose of MEDI2070 or placebo on Week 0(Day1) and Week 4 (Day 29) during the 12-week, double-blind, placebo-controlled, treatment period. At the completion of the double-blind, placebo-controlled, treatment period (Week 12), subjects will have the option to enter a 100-week, open-label, treatment period where they will receive open-label MEDI2070 (SC) Q4W (Week 12 through Week 112). Subjects will be followed for safety at 3 visits over 28 weeks after their last dose of IP. Subjects will also be contacted by phone 36 weeks after their last dose of IP for safety.

Arms: arm 1: MEDI2070 iv infusion arm 2: placebo iv infusion arm 3: MEDI2070 sc injection; open-label arm is available for all subjects upon completion of first placebo-controlled treatment period
Interventions: intervention 1: MEDI2070 intervention 2: placebo
Intervention descriptions: intervention 1: 1 iv infusion on Week 0 and Week 4 intervention 2: 1 iv infusion on Week 0 and Week 4

Protocol documents:
Clinical trial NCT02599194
Conditions: B-Cell Neoplasm Estrogen Receptor Negative HER2/Neu Negative Metastatic Renal Cell Cancer Progesterone Receptor Negative Stage III Mesothelioma Stage III Renal Cell Cancer Stage IIIA Breast Cancer Stage IIIA Non-Small Cell Lung Cancer Stage IIIB Non-Small Cell Lung Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer Stage IV Mesothelioma Stage IV Non-Small Cell Lung Cancer Stage IV Renal Cell Cancer Triple-Negative Breast Carcinoma
Sponsor: Andrei Iagaru
Start date: 2015-07-01; Completion date: 2016-12-14
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this phase 2 study trial is to evaluate the utility of the radiolabel 18F-FSPG used before and after treatment to diagnose, predict, and evaluate response to therapy in patients with a wide variety of metastatic cancers.

Detailed description:
OUTLINE:

Patients are evaluated with a PET/CT scan using the radiolabel 18F-FSPG \[18F-(S)-4-(3-fluoropropyl)-L-glutamic acid\] or 18F-FDG (\[18F\]-fluorodeoxyglucose), before and after therapeutic treatment.

PRIMARY OBJECTIVE:

Uptake of the radiolabel 18F-FSPG in patients with biopsy-proven cancer will be evaluated and compared to the uptake of 18F-FDG, before and after therapy (non-specified) in the same group of patients.

SECONDARY OBJECTIVES:

* Compare the agreement of the clinical assessment for cancer status between 18F-FSPG and 18F-FDG.
* Safety and tolerability of 18F-FSPG and 18F-FDG.

Arms: arm 1: Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.
Interventions: intervention 1: 18F-FSPG intervention 2: 18F-FDG
Intervention descriptions: intervention 1: Administered intravenously (IV) intervention 2: Administered intravenously (IV)

Protocol documents:
Clinical trial NCT01646021
Conditions: Mantle Cell Lymphoma
Keywords: Mantle cell lymphoma Relapsed mantle cell lymphoma Refractory mantle cell lymphoma Ibrutinib Bruton's tyrosine kinase inhibitor Temsirolimus
Sponsor: Janssen Research & Development, LLC
Start date: 2012-12-10; Completion date: 2016-12-15
Enrollment: 280 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of ibrutinib versus temsirolimus in patients with relapsed or refractory mantle cell lymphoma who received at least 1 prior chemotherapy regimen.

Detailed description:
This is a randomized (individuals assigned to study treatment by chance), open-label (identity of assigned study drug will be known), study to evaluate the efficacy and safety of ibrutinib when compared with temsirolimus in patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 1 prior rituximab-containing chemotherapy regimen. Approximately 280 eligible patients will be randomly assigned in a 1:1 ratio and stratified (grouped) by the number of prior lines of therapy (1 or 2 versus \>=3) and simplified MCL International Prognostic Index criteria to receive either ibrutinib by mouth (Treatment Arm A) or temsirolimus intravenous infusion (Treatment Arm B). The study will consist of screening, treatment, and posttreatment phases. Data will be collected on disease response to the treatment, progression-free survival, overall survival, subsequent anti-MCL therapies, patient reported outcomes, and medical resource utilization. Tumor samples, blood collected at multiple time points, and a bone marrow aspirate will be evaluated to identify markers predictive of response or resistance to ibrutinib. Serial pharmacokinetic (study of what the body does to a drug) samples will be collected as detailed in the protocol. Safety will be monitored throughout the study. Disease evaluations will be performed every 9 weeks for up to 15 months from the start of study drug, and every 24 weeks thereafter, until disease progression, death, or the clinical cutoff, whichever comes first. Patients who receive treatment with temsirolimus and have disease progression (confirmed by an Independent Review Committee) may be eligible to crossover and receive treatment with ibrutinib 560 mg orally, daily, on a 21-day cycle until disease progression, unacceptable toxicity, or study end. Data will be analyzed up to 3 years after the last patient is enrolled for the final follow-up.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ibrutinib intervention 2: Temsirolimus
Intervention descriptions: intervention 1: 560 mg once daily continuous (without interruption) by mouth for 21-day cycles intervention 2: 175 mg once daily intravenous infusion on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each 21-day cycle

Protocol documents:
Clinical trial NCT02181426
Conditions: Meniscectomy
Keywords: Knee Arthroscopy
Sponsor: Medical University of South Carolina
Start date: 2012-03-01; Completion date: 2016-12-15
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Ketorolac is administered as current practice to the majority of patients undergoing knee arthroscopy, the appropriate dose of ketorolac to be administered has not been evaluated.

Detailed description:
Past studies have examined different doses of ketorolac administered to patients after spinal fusion surgery and found that 7.5 mg every 6 hours was as effective as 15 or 30 mg every 6 hours in decreasing postoperative pain and patient opiate consumption. Since ketorolac side effects such as gastrointestinal and surgical site bleeding seem to be dose related, utilizing a lower dose of ketorolac may be more efficacious.

Arms: arm 1: participant receives 0 mg of Ketorolac arm 2: participant receives 7.5 mg of Ketorolac arm 3: participant receives 15 mg of Ketorolac arm 4: participant receives 30mg of Ketorolac
Interventions: intervention 1: Ketorolac Dose
Intervention descriptions: intervention 1: Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).

Protocol documents:
Clinical trial NCT02279862
Conditions: Prostate Cancer
Sponsor: Bristol-Myers Squibb
Start date: 2014-12-02; Completion date: 2016-12-15
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer.

Detailed description:
Prostate Cancer Clinical Trials Working Group 2 (PCWG2)

Response Evaluation Criteria In Solid Tumors (RECIST)

Arms: arm 1: Ipilimumab 3 mg/kg injection intravenously every 3 weeks for 4 doses in Induction phase. Subjects that are eligible to receive Ipilimumab in the Maintenance phase will be dosed every 12 weeks for a maximum of 3 years since the first induction dose arm 2: Ipilimumab 10 mg/kg injection intravenously every 3 weeks for 4 doses in Induction phase. Subjects that are eligible to receive Ipilimumab in the Maintenance phase will be dosed every 12 weeks for a maximum of 3 years since the first induction dose
Interventions: intervention 1: Ipilimumab
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02302092
Conditions: Urinary Tract Infection
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2015-12-01; Completion date: 2016-12-15
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effectiveness of antibiotic flomoxef with cefepime for the treatment of complicated urinary tract infections (cUTIs) in Russian adults.

Detailed description:
The drug being tested in this study is called Flomoxef. Flomoxef is being tested in people with a complicated urinary tract infection (cUTI) including a kidney infection. This study compares Flomoxef to Cefepime, another antibiotic.

The study enrolled 13 patients.

Participants are randomly assigned by a computer generated number to one of two treatment groups:

* Flomoxef - intravenous infusion 2g twice daily (every 12 hours); or
* Cefepime - intravenous infusion 1g twice daily (every 12 hours).

This multi-center trial is conducted at 4 sites in the Russian Federation. The overall time to participate in this study is 30+/-3 days. Participants make six visits to the clinic.

Study was prematurely terminated due to administrative and strategic reasons.

Arms: arm 1: Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours), for up to 12 days. arm 2: Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
Interventions: intervention 1: Flomoxef intervention 2: Cefepime
Intervention descriptions: intervention 1: Flomoxef intravenous infusion intervention 2: Cefepime intravenous infusion

Protocol documents:
Clinical trial NCT01706198
Conditions: Asthma
Keywords: respiratory adult asthma
Sponsor: GlaxoSmithKline
Start date: 2012-11-01; Completion date: 2016-12-16
Enrollment: 4233 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) or 200mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) ) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with the existing asthma maintenance therapy over twelve months in subjects diagnosed with asthma. 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 asthma in a localised geographical region of the UK

Arms: arm 1: fluticasone furoate (FF) + vilanterol (VI) once daily via a Novel Dry Powder Inhaler arm 2: inhaled corticosteroid (ICS) alone or in combination with a long acting beta2-agonist (LABA)
Interventions: intervention 1: fluticasone furoate + vilanterol intervention 2: inhaled corticosteroid with or without a long acting beta2-agonist
Intervention descriptions: intervention 1: once daily via a Novel Dry Powder Inhaler intervention 2: ICS alone or in combination with a long acting bronchodilator

Protocol documents:
Clinical trial NCT01245062
Conditions: Melanoma
Keywords: MEK inhibitor Cancer Metastatic Melanoma BRAF mutant metastatic melanoma GSK1120212
Sponsor: GlaxoSmithKline
Start date: 2010-11-22; Completion date: 2016-12-16
Enrollment: 322 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample. Subjects who have received up to one prior regimen of chemotherapy in the advanced or metastatic melanoma setting will be enrolled into the study. Subjects with any prior BRAF or MEK inhibitor use will be excluded. Approximately 297 subjects will be enrolled with 2:1 randomization (198 subjects into the GSK1120212 arm and 99 subjects into the chemotherapy arm). The primary endpoint for the statistical analysis will be a comparison of progression free survival for subjects receiving GSK1120212 compared to chemotherapy. Subjects who have progression on chemotherapy will be offered the option to receive GSK1120212.

Detailed description:

Arms: arm 1: MEK inhibitor arm 2: Investigator Choice of DTIC or paclitaxel arm 3: MEK inhibitor after documented progression on Chemotherapy Arm
Interventions: intervention 1: GSK1120212 intervention 2: Chemotherapy
Intervention descriptions: intervention 1: MEK inhibitor intervention 2: Investigator Choice of DTIC or paclitaxel

Protocol documents:
Clinical trial NCT01885936
Conditions: Pompe Disease
Keywords: LOPD Pompe Disease
Sponsor: Duke University
Start date: 2013-06-01; Completion date: 2016-12-16
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this study the study team proposes to investigate the efficacy of albuterol on motor function of individuals with Late Onset Pompe Disease (LOPD) who are receiving enzyme replacement therapy, given albuterol was well-tolerated in patients with Late Onset Pompe Disease.

Detailed description:

Arms: arm 1: Initially 4 mg daily for one week, then 4 mg BID per oral daily for the next 5 weeks. If the 4 mg BID per oral is well tolerated, the dose will be increased to 8 mg each morning/4 mg each evening for one week, followed by 8 mg BID per oral for the remainder of the study. arm 2: Initially one capsule daily for one week, then one capsule BID per oral daily for the next 5 weeks. If the one capsule BID per oral is well tolerated, the dose will be increased to two capsules each morning/one capsule each evening for one week, followed by two capsules BID per oral for the remainder of the study.
Interventions: intervention 1: Albuterol intervention 2: Placebo
Intervention descriptions: intervention 1: Initially 4 mg daily for one week, 4 mg BID per oral daily for the next 5 weeks. If the 4 mg BID per oral is well tolerated, the dose will be increased to 8 mg each morning/4 mg each evening for one week, followed by 8 mg BID per oral for the remainder of the study. intervention 2: Initially one capsule daily for one week, then one capsule BID per oral daily for the next 5 weeks. If the one capsule BID per oral is well tolerated, the dose will be increased to two capsules each morning/one capsule each evening for one week, followed by two capsules BID per oral for the remainder of the study.

Protocol documents:
Clinical trial NCT01957644
Conditions: Myelodysplastic Syndromes Leukemia, Myelomonocytic, Chronic
Sponsor: Boehringer Ingelheim
Start date: 2013-11-06; Completion date: 2016-12-16
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the maximum tolerated dose (MTD), safety, pharmacokinetics, and efficacy of volasertib in combination with azacitidine in patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) and not candidates for hematopoietic stem cell transplant

Detailed description:

Arms: arm 1: Volasertib (d1 - one hour iv.) + Azacitidine 75 mg/m2 once daily on Days 1-7 (7 consecutive days) (28-day cycle) arm 2: Volasertib (d 7 - one hour iv.) + Azacitidine 75 mg/m2 once daily on Days 1-7 (7 consecutive days) (28-day cycle) arm 3: Volasertib (d 1 and 7 - one hour iv.) + Azacitidine 75 mg/m2 once daily on Days 1-7 (7 consecutive days) (28-day cycle)
Interventions: intervention 1: Azacitidine intervention 2: Volasertib
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: