ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01903460
Conditions: Alagille Syndrome
Sponsor: Mirum Pharmaceuticals, Inc.
Start date: 2013-08-01; Completion date: 2015-03-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus placebo on the biochemical markers and pruritus associated with Alagille Syndrome.

Detailed description:

Arms: arm 1: LUM001 administered orally once each day arm 2: Placebo administered orally once each day
Interventions: intervention 1: LUM001 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01908062
Conditions: Opioid Use Disorder Alcohol Use Disorder
Keywords: Substance related disorders HIV naltrexone
Sponsor: Oregon Health and Science University
Start date: 2014-06-01; Completion date: 2015-03-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn how best to treat substance use disorders in an HIV clinic setting. Specifically, the purpose of this pilot study is to learn if extended-release naltrexone (XR-NTX) would be a feasible and acceptable treatment for HIV-infected individuals with opioid or alcohol use disorders.

Detailed description:

Arms: arm 1: The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups. arm 2: Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.
Interventions: intervention 1: Extended Release Naltrexone intervention 2: Treatment As usual
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01912222
Conditions: Advanced Solid Tumors Hematologic Malignancies
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2013-08-01; Completion date: 2015-03-01
Enrollment: 48 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 1, 2-part, pharmacokinetic study in patients with advanced solid tumors or hematologic malignancies and varying degrees of liver dysfunction (normal function, moderate hepatic impairement or severe hepatic impairment) as defined by the National Cancer Institute (NCI) Organ Dysfunction Working Group.

Detailed description:

Arms: arm 1: Experimental: Arm 1 (Normal hepatic function) In the 15 day period that constitutes Part A of the trial, patients will receive a single oral 4 mg dose of IXAZOMIB capsule on Day 1.

Patients from Part A will then have the option of continuing the study by participating in Part B, starting immediately after Part A, where they will receive IXAZOMIB on Days 1, 8, and 15 of a 28-day cycle arm 2: Experimental: Arm 2 (Moderate hepatic impairment) In the 15 day period that constitutes Part A of the trial, patients will receive a single oral 2.3 mg dose of IXAZOMIB capsule on Day 1.

Patients from Part A will then have the option of continuing the study by participating in Part B, starting immediately after Part A, where they will receive IXAZOMIB on Days 1, 8, and 15 of a 28-day cycle arm 3: Experimental: Arm 3 (Severe hepatic impairment) In the 15 day period that constitutes Part A of the trial, patients will receive a single oral 1.5 mg dose of IXAZOMIB capsule on Day 1.

Patients from Part A will then have the option of continuing the study by participating in Part B, starting immediately after Part A, where they will receive IXAZOMIB on Days 1, 8, and 15 of a 28-day cycle
Interventions: intervention 1: IXAZOMIB
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01955629
Conditions: Colorectal Cancer Metastatic
Sponsor: Sanofi
Start date: 2013-12-01; Completion date: 2015-03-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objectives:

Study Part 1: To determine the recommended dose for the aflibercept, oxaliplatin and capecitabine (XELOX) combination to be used in the Part 2 of the study.

Study Part 2: To assess the percentage of participants without progression of the disease at 6 months after the start of maintenance therapy with aflibercept single-agent, following the first-line induction therapy with XELOX and aflibercept combination in participants with previously untreated metastatic colorectal cancer.

Secondary Objective:

Study Part 2: Include the evaluation of progression free survival, overall survival, response to treatment, the overall safety (during induction and maintenance therapy) and the assessment of aflibercept pharmacodynamics and biomarkers parameters.

Detailed description:
The duration of the study for each participant includes a period for screening of up to 3 weeks, study drug administrations every 3 weeks up to disease progression, unacceptable toxicity or participant's refusal of further study treatment, followed by a minimum of 30-day follow-up after the last study treatment administration.

After study treatment discontinuation each participant will be followed-up until death, participant's refusal or end of study (whichever comes first).

This trial is being conducted in Europe, where the INN designation for the study molecule is "aflibercept" and this term is therefore used throughout the synopsis. In the US, the US proper name is "ziv-aflibercept".

Arms: arm 1: Aflibercept 6 mg/kg every 3 weeks (q3w) in combination with Oxaliplatin 100 mg/m\^2 q3w and Capecitabine 850 mg/m\^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg q3w as maintenance therapy up to disease progression or unacceptable toxicity or participant's refusal of further treatment.
Interventions: intervention 1: Aflibercept AVE0005 intervention 2: Oxaliplatin intervention 3: Capecitabine
Intervention descriptions: intervention 1: Pharmaceutical form: Concentrate for solution for infusion; Route of administration: Intravenous intervention 2: Pharmaceutical form: Concentrate for solution for infusion; Route of administration: Intravenous intervention 3: Pharmaceutical form: Tablets; Route of administration: Oral

Protocol documents:
Clinical trial NCT01959035
Conditions: Schizophrenia
Sponsor: H. Lundbeck A/S
Start date: 2013-10-01; Completion date: 2015-03-01
Enrollment: 88 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To obtain information on the safety, tolerability and effectiveness of aripiprazole once-monthly in a manner consistent with its intended use in everyday clinical practice in patients with schizophrenia who completed Study 14724A / NCT01795547.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Aripiprazole once-monthly
Intervention descriptions: intervention 1: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline

Protocol documents:
Clinical trial NCT01960387
Conditions: Acute Myeloid Leukemia
Keywords: AML clofarabine cytarabine persistent AML induction therapy
Sponsor: University of Pittsburgh
Start date: 2013-10-01; Completion date: 2015-03-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The combination of clofarabine and cytarabine is an effective and reasonably well-tolerated treatment regimen in patients with either relapsed/refractory or newly diagnosed AML. For this prospective study, we propose the use of clofarabine and cytarabine for second course induction therapy for patients with persistent AML after treatment with an anthracycline and cytarabine.

Detailed description:
The primary objective of this prospective study is to evaluate the efficacy (i.e., complete response rate) of clofarabine and cytarabine as second course therapy for the treatment of AML. The secondary objectives are to assess the treatment-related toxicities, to determine the overall and relapse-free survival for patients with AML who are treated with this regimen, and to evaluate potential factors that are predictive of response.

The investigational nature and objective of this study, the procedures involved and their associated risks, potential benefits, and potential alternative therapies will be explained to the patient, and a signed informed consent document will be obtained. Once consented, eligible patients will be treated by the acute leukemia service on the University of Pittsburgh Cancer Institute inpatient unit.

Prior to the start of chemotherapy, patients will receive dexamethasone and ondansetron as pre-medication. Clofarabine will then be administered as intravenous infusion on days 1 through 5. Patients will be monitored closely with vital signs. Cytarabine will then be given as intravenous infusion, starting 3 (maximum of 4) hours after the completion of clofarabine administration on days 1 through 5.

Arms: arm 1: Clofarabine will be administered as a 1-hour (range: 1 hour minimum to 2 hours maximum) intravenous infusion at a dose of 40mg/m2 daily on days 1 through 5. Cytarabine at a dose of 1g/m2 daily will then be given as a 2-hour intravenous infusion, starting 3 hours after the completion of clofarabine administration on days 1 through 5.
Interventions: intervention 1: Clofarabine intervention 2: Cytarabine
Intervention descriptions: intervention 1: Clofarabine will be administered as a 1-hour (range: 1 hour minimum to 2 hours maximum) intravenous infusion at a dose of 40mg/m2 daily on days 1 through 5. intervention 2: Cytarabine at a dose of 1g/m2 daily will be given as a 2-hour intravenous infusion, starting 3 hours after the completion of clofarabine administration on days 1 through 5.

Protocol documents:
Clinical trial NCT01960842
Conditions: Advanced Parkinson's Disease
Keywords: levodopa Advanced Parkinson's Disease carbidopa levodopa-carbidopa intestinal gel Safety and Efficacy
Sponsor: AbbVie
Start date: 2013-10-01; Completion date: 2015-03-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to measure the efficacy of ABT-SLV187 in subjects with advanced Parkinson's disease.

Detailed description:
The study was composed of a screening period followed by 2 sequential on-treatment periods, as follows:

* Screening Period (up to 28 days): determination of eligibility and discontinuation of antiparkinsonian disease medications other than levodopa-carbidopa immediate release (LC-oral) prior to nasojejunal (N-J) tube placement.
* N-J Test Period (2 to 14 days): first hospitalization period, Baseline assessments, placement of N-J tube, and optimization of levodopa-carbidopa intestinal gel (LCIG) treatment via N-J tube and infusion pump (participant was hospitalized for N-J tube placement but hospitalization was not required for entire duration of LCIG treatment optimization).
* PEG-J Period (12 weeks): second hospitalization period; placement of PEG-J tube; further optimization of LCIG treatment.

Arms: arm 1: All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.

The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour).
Interventions: intervention 1: Levodopa-carbidopa intestinal gel intervention 2: CADD-Legacy® 1400 ambulatory infusion pump intervention 3: PEG tube intervention 4: J-tube
Intervention descriptions: intervention 1: Dose levels will be individually optimized. Infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour) intervention 2: None intervention 3: percutaneous endoscopic gastrostomy tube intervention 4: jejunal tube

Protocol documents:
Clinical trial NCT01963611
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis Relapsing Remitting Plovamer acetate Copaxone
Sponsor: EMD Serono
Start date: 2013-10-01; Completion date: 2015-03-01
Enrollment: 255 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2, randomized, rater-blinded, 5-arm, parallel-group trial that will test 4 doses of plovamer acetate against the active comparator Copaxone in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). The trial will be conducted on an outpatient basis for minimum treatment duration of 40 weeks.

Detailed description:

Arms: arm 1: Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months. arm 2: Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months. arm 3: Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months. arm 4: Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months. arm 5: Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
Interventions: intervention 1: Plovamer acetate 0.5 milligram (mg) intervention 2: Copaxone 20 mg intervention 3: Plovamer acetate 3 mg intervention 4: Plovamer acetate 10 mg intervention 5: Plovamer acetate 20 mg
Intervention descriptions: intervention 1: Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months. intervention 2: Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months. intervention 3: Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months. intervention 4: Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months. intervention 5: Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.

Protocol documents:
Clinical trial NCT02002689
Conditions: PTCH1 or SMO Activated Solid and Hematologic Tumors
Keywords: Solid tumor malignancy, hematologic malignancy, mutation, translocations, signature, PTCH1, SMO, LDE225, endometrial cancer, colon cancer, bladder, NSCLC
Sponsor: Novartis Pharmaceuticals
Start date: 2014-02-01; Completion date: 2015-03-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this signal seeking study is to determine whether treatment with LDE225 demonstrates sufficient efficacy in hedgehog pathway-mutated solid tumors and/or hematologic malignancies to warrant further study

Detailed description:

Arms: arm 1: LDE225 800 mg (hard gelatin capsules) will be administered orally once daily on a continuous dosing schedule.
Interventions: intervention 1: LDE225
Intervention descriptions: intervention 1: LDE225 800 mg (hard gelatin capsules) will be administered orally once daily on a continuous dosing schedule

Protocol documents:
Clinical trial NCT02010242
Conditions: Type 2 Diabetes Mellitus With Diabetic Nephropathy
Keywords: Type 2 diabetes Proteinuria Albuminuria
Sponsor: Calliditas Therapeutics AB
Start date: 2013-10-01; Completion date: 2015-03-01
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
NADPH oxidase enzymes (NOX) have been implicated in the development of several diabetic complications including diabetic nephropathy. GKT137831 is the first in class NOX1/4 inhibitor.

The primary objective of this study is to evaluate the efficacy of oral GKT137831 in patients with residual albuminuria despite maximal inhibition of the renin angiotensin aldosterone system.

Detailed description:
A double-blind, placebo-controlled, randomized, multicenter, parallel group Phase 2 study assessing a 12-week period of treatment with oral GKT137831 administered in addition to standard of care for patients with type 2 diabetes.

Arms: arm 1: GKT137831 100 mg capsules twice a day arm 2: Placebo capsule twice a day
Interventions: intervention 1: GKT137831 intervention 2: Placebo
Intervention descriptions: intervention 1: 1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment intervention 2: 1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.

Protocol documents:
Clinical trial NCT02020135
Conditions: Prostate Cancer
Sponsor: Progenics Pharmaceuticals, Inc.
Start date: 2013-10-01; Completion date: 2015-03-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
PSMA ADC 2301EXT is an open-label study to further assess the anti-tumor activity as measured by radiographic imaging and biomarkers, safety and tolerability of Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) in subjects with mCRPC. Subjects who have participated in the PSMA ADC 2301 study and who, in the opinion of the Principal Investigator are likely to benefit from continued treatment with PSMA ADC are eligible for the PSMA ADC 2301 extension study. Subjects who are benefiting from treatment may be able to receive up to an additional eight to sixteen doses (every 3 weeks) of PSMA ADC.

Detailed description:

Arms: arm 1: Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.
Interventions: intervention 1: PSMA ADC
Intervention descriptions: intervention 1: Upon recommendation from the PI and after Sponsor approval, a subject benefiting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations.

Protocol documents:
Clinical trial NCT02046200
Conditions: Alcohol Use Disorder
Keywords: ivermectin, alcoholism, alcohol use disorder, treatment
Sponsor: University of California, Los Angeles
Start date: 2014-02-01; Completion date: 2015-03-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Current pharmacotherapies for alcohol use disorders (AUDs) have limited efficacy. Thus, the development of effective treatments for AUDs represents an important public health objective. Repositioning, i.e. using existing approved drugs for other indications, represents a fast and economically feasible approach for drug development. Ivermectin (IVM) is an FDA-approved antiparasitic medication that can significantly reduce alcohol intake in mice, suggesting that it may be useful in the treatment of AUDs in humans. The goal of this project is to provide key clinical evidence that IVM can be repositioned as a novel therapeutic agent to treat AUDs.

Detailed description:
Current pharmacotherapies for alcohol use disorders (AUDs) have limited efficacy. Thus, the development of effective treatments for AUDs represents an important public health objective. Repositioning, i.e. using existing approved drugs for other indications, represents a fast and economically feasible approach for drug development. Ivermectin (IVM) is an FDA-approved antiparasitic medication that can significantly reduce alcohol intake in mice, suggesting that it may be useful in the treatment of AUDs in humans. The goal of this project is to provide key clinical evidence that IVM can be repositioned as a novel therapeutic agent to treat AUDs. We will enroll 10 alcohol dependent individuals in a placebo-controlled randomized pilot safety trial of IVM (30 mg orally once) over a 2-day (1-night) inpatient stay at the UCLA CTRC and employ a well-characterized battery of behavioral paradigms (i.e., alcohol administration and cue exposure). The goals of the study are to test: (a) the safety of combining IVM, at a dose currently shown to be safe in humans (30 mg), with moderate doses of alcohol (0.08 g/dl); and (b) whether IVM reduces the reinforcing effects of alcohol during alcohol administration and whether it reduces alcohol craving during cue exposure, as compared to placebo.

Arms: arm 1: Ivermectin 30 mg single dose arm 2: Matched placebo, single dose
Interventions: intervention 1: Ivermectin intervention 2: Placebo intervention 3: Alcohol
Intervention descriptions: intervention 1: Ivermectin is a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum antiparasitic avermectin. intervention 2: Matched placebo intervention 3: None

Protocol documents:
Clinical trial NCT02068027
Conditions: Painful Diabetic Neuropathy Diabetic Neuropathy Neuropathy
Keywords: Diabetes Mellitus Pain Foot pain Neuropathy
Sponsor: BioDelivery Sciences International
Start date: 2014-03-01; Completion date: 2015-03-01
Enrollment: 260 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether clonidine gel is an effective treatment for reducing the pain associated with painful diabetic neuropathy.

Detailed description:
Study CLO 290 was a multicenter, randomized, double blind, placebo controlled, 2 arm parallel group study of Clonidine Gel in the treatment of pain associated with PDN. Subjects were randomly assigned in a 1:1 ratio to receive 1 of 2 treatments applied topically TID to both feet for 85 days: Clonidine Gel (3.9 mg of clonidine HCl total daily dose), or Placebo Gel (vehicle without clonidine). Approximately 140 adult subjects with symmetrical distal PDN were expected to be randomized into the study. However, a pre-planned fully blinded interim analysis was performed when 70 subjects had completed the study for the purpose of re estimating sample size. Following the recommendation of the independent, third party statistician who conducted the interim analysis, the sample size was adjusted to allow approximately 260 subjects to be randomized into the study.

The study included 5 phases: Screening Phase (up to 21 days duration), Baseline Phase (Day 14 to Day 8), Placebo Lead in Phase (Day -7 to Day 1), Double blind Treatment Phase (85 days), and a Post-treatment Follow up Phase (7 days, only for subjects not enrolling in the open label long term safety study, CLO 311).

Arms: arm 1: Clonidine hydrochloride topical gel, 0.1% arm 2: Placebo gel of identical appearance as active treatment
Interventions: intervention 1: Clonidine Gel 0.1% intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: