ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT03021343
Conditions: Arrhythmia
Keywords: Atrial fibrillation Colchicine Cardiac surgery
Sponsor: Jordan Collaborating Cardiology Group
Start date: 2012-10-01; Completion date: 2015-02-01
Enrollment: 360 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the role of colchicine in the prevention of atrial fibrillation in patients undergoing open heart surgery. Half of participants will receive colchicine and the other half will not

Detailed description:
Atrial fibrillation (AF) is the most common arrhythmia in patients undergoing cardiac surgery and is estimated to occur in 26% of all cardiac surgery patients. It can lead to increase morbidity, mainly due to hemodynamic instability and thromboembolic complications, and to increased hospital stay with its associated higher health care cost.

Previous studies have demonstrated that increased inflammation may precede AF and, therefore, interventions that reduce the inflammatory process may help reduce the incidence of AF. Colchicine has potent anti-inflammatory properties and may therefore be capable of reducing the incidence of AF.

This study aims to determine whether the administration of colchicine starting the day before cardiac surgery and continuing until discharge may lead to reduction in post-operative AF.

Arms: arm 1: Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing \<70 kg or intolerant to the full dose. arm 2: In this arm no active medication was administered
Interventions: intervention 1: Colchicine
Intervention descriptions: intervention 1: colchicine given as per trial protocol

Protocol documents:
Clinical trial NCT02175680
Conditions: HIV Human Immunodeficiency Virus
Keywords: HIV-1 HIV Treatment Substitution PRO 140 PRO140 CytoDyn Amarex
Sponsor: CytoDyn, Inc.
Start date: 2014-04-16; Completion date: 2015-02-02
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on combination antiretroviral therapy.

Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks. Total treatment duration with PRO 140 will be 14 weeks with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment, and one week overlap at the end of the treatment in subjects who do not experience virologic failure.

Detailed description:
This study is a Phase 2b, multi-center study designed to evaluate the efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in patients who are stable on combination antiretroviral therapy.

Patient enrollment will be staggered in this study to facilitate adequate safety monitoring. A lead cohort will include 12 subjects. Enrollment of additional 28 subjects will not be initiated until it is approved by the independent Data Monitoring Committee (DMC).

Consenting patients will be shifted from combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks. Total treatment duration with PRO 140 will be up to 14 weeks with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment and also one week overlap at the end of the treatment in subjects who do not experience Virologic Failure.

PRO 140 will be administered as a 350 mg subcutaneous injection weekly for up to 14 weeks. Study participants will be monitored for viral rebound on a weekly basis following initiation of PRO 140 monotherapy and will re-initiate their previous antiretroviral regimen if plasma HIV-1 RNA levels rise above 400 copies/ml on two consecutive blood draws at least 3 days apart.

The study will have three phases: Screening Phase, Treatment Phase and Follow-up Phase.

The primary objective is to assess efficacy of PRO 140 monotherapy for the maintenance of viral suppression following substitution of antiretroviral therapy in patients who are stable on combination antiretroviral therapy.

The secondary objective of the trial is to assess the clinical safety and tolerability parameters following substitution of antiretroviral therapy in patients who are stable on combination antiretroviral therapy.

Arms: arm 1: PRO 140 350mg weekly SQ injection.
Interventions: intervention 1: PRO 140 intervention 2: Historical data
Intervention descriptions: intervention 1: CCR5 Antagonist intervention 2: Historical data (i.e., time to HIV-1 RNA viral load \> 500 copies/mL of 29 days).

Protocol documents:
Clinical trial NCT02068352
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis, Eczema
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2014-06-20; Completion date: 2015-02-03
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the effectiveness and safety of 2 concentrations of OPA-15406 compared to vehicle in participants with atopic dermatitis (AD).

Detailed description:
AD is a disease mainly characterized by pruritic eczema, and those with the disease experience repeated exacerbations and remissions. Therapeutic guidelines for the disease, currently being developed in many countries, all recognize AD as chronic eczema that is accompanied by the physiological dysfunction of the skin and in which inflammation is caused by various nonspecific stimuli or specific allergens. OPA 15406 is a type-4 phosphodiesterase (PDE4) inhibitor. PDE4 inhibitors are thought to be useful for allergic inflammatory diseases. This is a Phase 2 dose ranging study to evaluate the efficacy of two concentrations of OPA 15406 ointment compared to vehicle, when administered topically twice daily in participants with mild to moderate AD.

Arms: arm 1: OPA-15406 0.3% ointment was applied topically twice daily (BID) to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. arm 2: OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. arm 3: OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
Interventions: intervention 1: OPA-15406 intervention 2: Vehicle ointment
Intervention descriptions: intervention 1: OPA-15406 topical ointment intervention 2: OPA-15406 1%-matching placebo topical ointment

Protocol documents:
Clinical trial NCT03489304
Conditions: HIV/AIDS Clinical Depression
Keywords: Insomnia Zaleplon
Sponsor: University of Pennsylvania
Start date: 2014-04-03; Completion date: 2015-02-04
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In HIV positive patients with sleep onset insomnia and receiving pharmacologic treatment for comorbid depression, the proposed study aims to evaluate the impact of zaleplon on sleep measures determined by insomnia severity index (ISI) and Epworth sleepiness scale (ESS).

Detailed description:
An estimated \>50% of HIV positive individuals report insomnia. Insomnia and other sleep disturbances negatively impact outcomes in this population by contributing to metabolic dysfunction, reducing quality of life, and impairing psychosocial functioning. Additionally, in HIV depressed populations, insomnia may hinder remission from clinical depression. To date, there have been no pharmacotherapeutic studies treating insomnia in this population, emphasizing the need to determine whether known hypnotic medications work as effectively in HIV positive patients, including those with comorbid depression. Non-benzodiazepine hypnotics represent an attractive pharmacotherapy for treatment of insomnia in a depressed population, as there are reduced side effects and abuse potential compared to classical benzodiazepines. Consequently, an open-label study evaluating zaleplon for insomnia in HIV positive patients with comorbid depression warrants further study.

Arms: arm 1: Open-label zaleplon 5-10mg daily
Interventions: intervention 1: Zaleplon
Intervention descriptions: intervention 1: non-benzodiazepine hypnotic agent

Protocol documents:
Clinical trial NCT01767129
Conditions: Dyskinesia Parkinson's Disease
Keywords: levodopa dyskinesia parkinson's disease AVP-923 dextromethorphan quinidine
Sponsor: Avanir Pharmaceuticals
Start date: 2013-10-16; Completion date: 2015-02-05
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To evaluate the efficacy, safety, and tolerability of AVP-923 capsules containing 45 mg dextromethorphan and 10 mg quinidine (AVP-923-45) compared to placebo for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).

Detailed description:
Proof-of-concept phase 2a, double-blind, randomized, placebo-controlled, crossover study.

Arms: arm 1: AVP-923-45 twice daily for 14 days arm 2: Placebo twice a day for 14 days
Interventions: intervention 1: AVP-923-45 intervention 2: Placebo
Intervention descriptions: intervention 1: One capsule twice daily for 14 days intervention 2: One capsule twice daily for 14 days

Protocol documents:
Clinical trial NCT03605758
Conditions: Strongyloides Stercoralis Infection Strongyloidiasis
Keywords: Ivermectin S. stercoralis parasite helminth Filariform larvae Baermann technique
Sponsor: Albert Einstein College of Medicine
Start date: 2012-05-01; Completion date: 2015-02-05
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to evaluate the serologic response in patients with S. stercoralis infection after treatment with a regimen of two single doses of 200 µg/kg of ivermectin given 2 weeks apart versus a regimen of two single doses of 200 µg/kg of ivermectin given in two consecutive days.

Detailed description:
Patients will be randomly assigned to receive 2 single doses of ivermectin at 200 µg/kg 2 weeks apart versus ivermectin at 200 µg/kg for 2 consecutive days. Patients will be randomized 50-50 to the study groups using the date of birth and a random number table. All patients will be interviewed to obtain the medical history during the initial evaluation. Patients will be asked about demographic data on a questionnaire written in English and Spanish. Physical exams, baseline blood cell counts, serum chemistries, HTLV-1(human T-cell lymphotrophic virus) serology, an IgE (immunoglobulin E), a stool sample for O \&P, and a pregnancy test will be performed as routine care all patients currently receive in our clinic.Procedures: Strongyloides serology will be performed in the parasitology laboratory of Jacobi Hospital with an in-house ELISA that uses a 31-kDA(kilodalton) recombinant protein antigen (termed NIE) derived from L3 stage of S. stercoralis and purified from E. coli BL21 containing pET30b plasmid. Once the in-house serology is performed serum will be banked, so it can be available to run in paired with samples taken during follow up visits. Blood samples will be also collected and sent to the Laboratory of Parasitic Diseases (LPD) at the NIAID- National Institutes of Health (NIH) to perform other serological techniques including the Luciferase Immunoprecipitation Systems Assay (LIPS) based on NIE and the recombinant antigen S. stercoralis immunoreactive antigen (SsIR). In addition, stools will be collected from all patients and will be fixated in SAF(sodium acetate, acetic acid and formalin), to check for Strongyloides stercoralis larvae. If possible, fresh stool will be obtained to check for larvae using the Baermann technique and an aliquot will be frozen and sent to the NIH for DNA extraction and PCR(polymerase chain reaction as).

Arms: arm 1: Participants will receive 200 µg/kg of ivermectin daily for two consecutive days with breakfast. arm 2: Participants will receive 200 µg/kg of ivermectin on day one and day 14 with breakfast.
Interventions: intervention 1: Ivermectin
Intervention descriptions: intervention 1: Ivermectin is an anti-parasitic

Protocol documents:
Clinical trial NCT01977482
Conditions: Anaemia
Keywords: hemoglobin recombinant human erythropoietin Chronic kidney disease hemodialysis pharmacokinetics erythropoiesis stimulating agents Anemia GSK1278863
Sponsor: GlaxoSmithKline
Start date: 2013-11-01; Completion date: 2015-02-06
Enrollment: 216 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is intended to evaluate the dose-response relationship of GSK1278863 over the first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks to maintain hemoglobin (Hgb) level in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease (CKD) who are switched from a stable dose of recombinant human erythropoietin (rhEPO). The data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.

Detailed description:

Arms: arm 1: Subjects will take GSK1278863 4 mg blinded once daily (OD) orally for 4 weeks with a glass of water. From Week 4, study medication will continue to be administered OD and the dose will be adjusted based on Hgb levels dose every 4 weeks till Week 24. arm 2: Subjects will take GSK1278863 6 mg blinded OD orally for 4 weeks with a glass of water. From Week 4, study medication will continue to be administered OD and the dose will be adjusted based on Hgb levels dose every 4 weeks till Week 24. arm 3: Subjects will take GSK1278863 8 mg blinded OD orally for 4 weeks with a glass of water. From Week 4, study medication will continue to be administered OD and the dose will be adjusted based on Hgb levels dose every 4 weeks till Week 24. arm 4: Subjects will take GSK1278863 10 mg blinded OD orally for 4 weeks with a glass of water. From Week 4, study medication will continue to be administered OD and the dose will be adjusted based on Hgb levels dose every 4 weeks till Week 24. arm 5: Subjects will take GSK1278863 12 mg blinded OD orally for 4 weeks with a glass of water. From Week 4, study medication will continue to be administered OD and the dose will be adjusted based on Hgb levels dose every 4 weeks till Week 24. arm 6: Subjects will take GSK1278863 matching placebo blinded OD orally for 4 weeks with a glass of water. From Week 4, rhEPO will be administered and the dose will be adjusted based on Hgb levels dose every 4 weeks till Week 24.
Interventions: intervention 1: GSK1278863 intervention 2: Placebo intervention 3: rhEPO
Intervention descriptions: intervention 1: Film coated tablets containing 1 mg, 2 mg, 5 mg, or 25 mg of GSK1278863 intervention 2: Matching placebo tablet for GSK1278863 intervention 3: rhEPO will be procured from local market

Protocol documents:
Clinical trial NCT02411929
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-10-29; Completion date: 2015-02-09
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the absolute oral bioavailability (F) and fraction absorbed (Fa) of ertugliflozin following oral administration of unlabeled ertugliflozin (MK-8835) and intravenous (IV) and oral administration of 14\^C-labeled ertugliflozin in healthy male participants.

Detailed description:

Arms: arm 1: Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C. The 14\^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose. → Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C. Both the unlabeled and 14\^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart). Dosing in Periods 1 and 2 will be separated by a washout of at least 11 days.
Interventions: intervention 1: Unlabeled ertugliflozin for oral use intervention 2: 14^C-labeled ertugliflozin for IV use intervention 3: 14^C-labeled ertugliflozin for oral use
Intervention descriptions: intervention 1: 15 mg oral (3 x 5 mg tablets) intervention 2: 100 µg (10 µg/mL solution IV) containing approximately 400 nCi 14\^C (ie, radiolabeled ertugliflozin) intervention 3: 100 µg (10 µg/mL solution oral) containing approximately 400 nCi 14\^C (ie, radiolabeled ertugliflozin)

Protocol documents:
Clinical trial NCT01655823
Conditions: Pain Peripheral Neuropathy Neuropathic Pain
Keywords: Pain Puffer fish Tetrodotoxin TTX Neuropathy Chemotherapy WEX Pharmaceuticals
Sponsor: Wex Pharmaceuticals Inc.
Start date: 2012-07-01; Completion date: 2015-02-11
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Chemotherapy-induced peripheral neuropathy (CIPN) is a major dose-limiting side effect of many chemotherapeutic agents including vincristine, paclitaxel, cisplatin, oxaliplatin, bortezomib and ixabepilone. Chemotherapy-induced peripheral neuropathy commonly occurs in greater than 40% of patients. To improve the peripheral neuropathy, the chemotherapy dosing is often either decreased or discontinued potentially affecting tumor responsiveness, prognosis, and survival.

There is an unmet medical need for treatment of cancer patients with chemotherapy induced neuropathic pain (CINP) and the proposed study will investigate the efficacy and safety of multiple dose levels of tetrodotoxin (TTX) versus placebo in moderate to severe neuropathic pain caused by chemotherapy.

Detailed description:

Arms: arm 1: Placebo for injection (1 ml volume), twice a day for four consecutive days. arm 2: Low dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days. arm 3: Mid-range dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days. arm 4: Max dose Tetrodotoxin injectable (1 ml volume), once a day in the morning for four consecutive days and Placebo for injection (1 ml volume), once a day in the afternoon for four consecutive days. Total of 4 treatment days. arm 5: Max dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Interventions: intervention 1: Placebo intervention 2: Tetrodotoxin
Intervention descriptions: intervention 1: Sham treatment acting as control arm intervention 2: Comparison of different dosages of Tetrodotoxin

Protocol documents:
Clinical trial NCT01152788
Conditions: Melanoma
Sponsor: NCIC Clinical Trials Group
Start date: 2010-08-05; Completion date: 2015-02-13
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out what effects an experimental drug, called interleukin 21 or rIL-21, will have on malignant melanoma and whether these effects look promising compared to dacarbazine. In addition, this study will look at the side effects of rIL-21, and some special blood tests will be done to check the level of rIL-21 in the blood. This study will also look at previously removed melanoma tissue to determine which patients might benefit most from this treatment.

This research is being done because currently there is no effective treatment for this type of cancer.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: rIL-21 intervention 2: Dacarbazine
Intervention descriptions: intervention 1: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks intervention 2: 1000 mg/m2 IV Day 1, every 3 weeks

Protocol documents:
Clinical trial NCT01259869
Conditions: Glioblastoma
Sponsor: NCIC Clinical Trials Group
Start date: 2011-04-01; Completion date: 2015-02-13
Enrollment: 34 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 glioblastoma multiforme.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: PX-866
Intervention descriptions: intervention 1: 1 cycle = 8 weeks on study PX-866 - 8mg PO Daily

Protocol documents:
Clinical trial NCT00979576
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Boehringer Ingelheim
Start date: 2009-10-16; Completion date: 2015-02-16
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this trial are to estimate the following in Japanese patients with advanced NSCLC of stage IIIB/IV or with recurrence after failure of first-line chemotherapy.

Phase I part The objective of the phase I part is to define the Maximum Tolerated Dose (MTD) of BIBF 1120 at a dose level up to twice daily 200 mg with standard dose of pemetrexed (500 mg/m\^2) and to determine the Recommended Dose (RD) for the phase II part.

Phase II, to investigate the efficacy and safety of BIBF 1120 in combination with pemetrexed (500 mg/m\^2) as compared to pemetrexed (500 mg/m\^2) + placebo

Detailed description:

Arms: arm 1: Phase I part: Find MTD by using low, medium or high BIBF 1120 twice daily and 500mg/m\^2 pemetrexed once every 3 weeks arm 2: PHase II part: Study arm arm 3: Phase II part: Comparator arm
Interventions: intervention 1: BIBF 1120 M + Pemetrexed intervention 2: BIBF 1120 H + Pemetrexed intervention 3: BIBF 1120 RD + Pemetrexed intervention 4: BIBF 1120 L + Pemetrexed intervention 5: BIBF 1120 Placebo + Pemetrexed
Intervention descriptions: intervention 1: BIBF 1120 medium dose bid+ Pemetrexed 500 mg/m\^2 intervention 2: BIBF 1120 high dose bid+ Pemetrexed 500 mg/m\^2 intervention 3: confirmed dose of BIBF 1120 bid + Pemetrexed 500 mg/m\^2 intervention 4: BIBF 1120 low dose bid+ Pemetrexed 500 mg/m\^2 intervention 5: placebo BIBF 1120 bid + Pemetrexed 500 mg/m\^2

Protocol documents: