ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00940771
Conditions: Pediatric HIV HIV Infections
Keywords: HIV Lipids Atazanavir Pediatric treatment experienced
Sponsor: Phoenix Children's Hospital
Start date: 2009-08-26; Completion date: 2016-11-23
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The hypothesis for this study is whether a treatment regimen containing Atazanavir in combination with Ritonavir will work as well as other regimens containing a protease inhibitor and/or a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) at controlling HIV disease in children who are HIV+ and have high cholesterol or high triglycerides. . In this study, children who have high cholesterol or high triglycerides as a result of their HIV medicines, will have the PI or NNRTI in their medication regimen changed to Atazanavir, which is a PI in combination with a low dose of Ritonavir (another PI). Atazanavir has been shown in adults to result in lower cholesterol and triglycerides than other PI's and NNRTI's. The dose of Atazanavir and Ritonavir will be according to the Package Insert for this drug that is FDA approved for children. They will continue taking the other medications from the pre-study regimen. Children will take study drug for 24 weeks, and will be able to continue study drug after the study using commercially available drug. Lab tests and a physical exam will be undertaken at 4 weeks, 12 weeks and 24 weeks after starting study drug to determine how effective the new drug is and to monitor for possible side effects.

Detailed description:
The primary objective of this study is to determine if Atazanavir and Ritonavir together will be as effective as the child's previous regimen in keeping the level of virus in the blood stream at such a low level it can't be found and whether that combination will be as effective as the previous regimen in keeping the infection fighting cells in the blood at the same level.

Secondary objectives will be:

* To determine if cholesterol and triglyceride levels drop in children switching to Atazanavir and Ritonavir from other medication regimens.
* To evaluate if Atazanavir and Ritonavir result in an increase in patient satisfaction and patient reported adherence and a decrease in symptoms related to medication side effects.

Inclusion Criteria are:

* On the same medication regimen at least 3 months
* Weight equal to or greater than 25kg
* Able to swallow pills or willing to learn
* Have a parent or guardian willing and able to sign informed consent
* Not be taking a medication which interacts with Atazanavir
* Not be currently taking Sustiva

Arms: arm 1: Boosted Atazanavir was switched for the PI or NNRTI in the patients regimen
Interventions: intervention 1: Boosted Atazanavir
Intervention descriptions: intervention 1: Boosted Atazanavir, once a day dose adjusted for child's weight for 6 months.

Protocol documents:
Clinical trial NCT02421172
Conditions: Hidradenitis Suppurativa (Acne Inversa)
Keywords: Hidradenitis Suppurativa
Sponsor: Novartis Pharmaceuticals
Start date: 2015-04-13; Completion date: 2016-11-23
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double blind, multicenter study in patients with moderate to severe chronic hidradenitis suppurativa in parallel groups, to determine the efficacy and safety of multiple doses of CJM112 in comparison to placebo. The study has two periods to explore preliminary dose effects.

Detailed description:

Arms: arm 1: Period 1: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses arm 2: Period 1: Placebo subcutaneously (s.c.) weekly for 5 doses followed by bi-weekly for 5 doses for a total of 10 doses arm 3: Period 2: Placebo subcutaneously (s.c.) weekly for 5 doses then bi-weekly for 5 doses for a total of 10 doses this group.This group was on CJM112 High Dose in Period 1 arm 4: Period 2: CJM112 Low Dose subcutaneously (s.c.) weekly for 5 doses then bi-weekly for 5 doses for a total of 10 doses this group.This group was on Placebo in Period 1 arm 5: Period 2: CJM112 High Dose subcutaneously (s.c.) weekly for 5 doses then bi-weekly for 5 doses for a total of 10 doses this group.This group was on Placebo in Period 1
Interventions: intervention 1: CJM112 intervention 2: Placebo
Intervention descriptions: intervention 1: CJM112 Fully human IgG1 monoclonal antibody intervention 2: None

Protocol documents:
Clinical trial NCT02147158
Conditions: Leiomyoma Uterine Hemorrhage
Sponsor: Allergan
Start date: 2014-01-29; Completion date: 2016-11-24
Enrollment: 432 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids

Detailed description:

Arms: arm 1: Ulipristal Acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2. arm 2: UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2. arm 3: UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses. arm 4: UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses. arm 5: Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2. arm 6: Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
Interventions: intervention 1: Ulipristal acetate (UPA) intervention 2: Placebo
Intervention descriptions: intervention 1: Ulipristal acetate (UPA) tablet. intervention 2: Matching placebo tablet.

Protocol documents:
Clinical trial NCT02491684
Conditions: Asthma
Keywords: asthma Upper Respiratory Tract Infection exacerbation Interferon efficacy safety prevention
Sponsor: AstraZeneca
Start date: 2015-07-21; Completion date: 2016-11-24
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to investigate if inhaled Interferon beta-1a is safe and tolerated, and can prevent or reduce the severity of asthma attacks when administered to asthma patients at the onset of symptoms of common cold or influenza

Detailed description:
The study will consist of a Pre-Treatment Phase followed by a Treatment Phase. Patients are screened and enter the Pre-Treatment phase where they remain until they develop symptoms of a common cold or the flu. During this Pre-Treatment Phase patients will be asked daily if they think they have a common cold or the flu. When the patient answers yes to the question that he/she is coming down with a common cold or the flu, arrangements are made to evaluate the patient at the study site and, if eligible, enters the Treatment Phase. Baseline assessments are performed and the patient is randomized 1:1 to receive 24 μg (metered dose) inhaled Interferon beta-1a or placebo once daily for 14 days (delivered by the I-neb® device \[Philips Respironics\]). Treatment should start as soon as possible but no later than 48 hours after the onset of the first of the common cold or flu symptoms. Patients will be assessed with regards to exacerbations and changes in respiratory symptoms and reliever medication use at home using an ePRO device. Lung function will be measured both at home by the patients and at the study site. There will be five clinical visits during the Treatment Phase and two visits after the end of treatment; efficacy and safety will be monitored until 2-3 weeks after end of treatment when a final follow-up visit will take place.

The study population will comprise adult asthmatic patients on a maintenance treatment of medium to high dose inhaled corticosteroids and a second controller medication (eg, long- acting β2 agonist), with a documented history of at least two severe exacerbations within the last 24 months, of which at least one has occurred during the last 12 months, and it is suspected by the patient that these aforementioned exacerbations were triggered by an upper respiratory tract infection (ie, related to symptoms of a common cold or the flu).

Arms: arm 1: Placebo, once daily inhalation for 14 days arm 2: Interferon beta-1a, 24 μg (metered dose) once daily inhalation for 14 days
Interventions: intervention 1: Interferon beta-1a Nebuliser solution 48 μg/mL intervention 2: Placebo
Intervention descriptions: intervention 1: Interferon beta-1a, 0,5 ml (24 μg, metered dose) once daily inhalation for 14 days intervention 2: Placebo solution for once daily inhalation for 14 days

Protocol documents:
Clinical trial NCT02761252
Conditions: Seasonal Allergic Rhinoconjunctivitis Asthma
Keywords: Bilastine Montelukast total symptom score AQLQ
Sponsor: Menarini International Operations Luxembourg SA
Start date: 2016-04-13; Completion date: 2016-11-24
Enrollment: 454 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare concomitant administration of Montelukast and Bilastine to Montelukast and Bilastine monotherapies in patients with SARC and asthma

Detailed description:
The present study (SKY) was designed to show if once daily oral combination therapy with Montelukast 10 mg and Bilastine 20 mg is superior to monotherapy with Bilastine 20 mg in patients with Seasonal Allergic RhinoConjunctivitis (SARC) and comorbid mild to moderate asthma on total symptom scores (TSS) and if the combination therapy reflects an improvement in quality of life as assessed via the Asthma Quality of Life Questionnaire (AQLQ) over a longer time period when compared to monotherapies with Montelukast 10 mg and Bilastine 20 mg. Mild to moderate asthma was defined according to the criteria of the Global Initiative for Asthma, i.e., GINA criteria 2 and 3 (GINA, 2012). The study population included patients inadequately controlled on inhaled corticosteroids and in whom "as-needed" short acting beta-agonists provided inadequate clinical control.

Arms: arm 1: Bilastine 20 mg, 10 blister containing 10 tablets + Montelukast 10 mg, 10 blister containing 10 film coated tablets each for treatment arm 2: Bilastine 20 mg, 10 blister containing 10 tablets + Placebo Montelukast, 10 blister containing 10 film coated tablets each. arm 3: Placebo Bilastine, 10 blister containing 10 tablets + Montelukast 10 mg, 10 blister containing 10 film coated tablets each.
Interventions: intervention 1: Bilastine 20mg intervention 2: Montelukast 10mg intervention 3: Placebo Bilastine 20mg intervention 4: Placebo Montelukast 10mg
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01496131
Conditions: Prostate Cancer
Keywords: Tecemotide Prostate Cancer Goserelin Cyclophosphamide Radiotherapy
Sponsor: EMD Serono
Start date: 2011-10-24; Completion date: 2016-11-25
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study examines tecemotide (L-BLP25) in combination with standard treatment for prostate cancer.

Detailed description:

Arms: arm 1: Radiation therapy in combination with androgen deprivation therapy (ADT). arm 2: Standard therapy (radiation therapy in combination with ADT) plus tecemotide (L-BLP25).
Interventions: intervention 1: Radiation therapy intervention 2: Goserelin intervention 3: Cyclophosphamide intervention 4: Tecemotide (L-BLP25)
Intervention descriptions: intervention 1: Radiation therapy will be administered at a daily dose of 180 centigrays (cGy) 5 days a week for approximately 6 to 8 weeks. intervention 2: ADT (Goserelin) will be administered at a dose of 10.8 milligrams (mg) subcutaneously every 3 months for 24 months for the high risk group and for 6 months in the intermediate risk group, starting 2-3 months prior to radiation therapy. intervention 3: Cyclophosphamide will be administered at a single dose of 300 milligrams per square meter (mg/m\^2) to a maximum of 600 mg, as an intravenous injection 3 days prior to the first administration of tecemotide (L-BLP25). intervention 4: Tecemotide (L-BLP25) will be administered at a dose of 918 microgram (mcg) as subcutaneous injection every 2 weeks for 5 doses followed by every 6 weeks for an additional 4 doses, starting 2-3 months prior to radiation therapy and on the same day that ADT began.

Protocol documents:
Clinical trial NCT02517866
Conditions: Essential Hypertension Type 2 Diabetes Mellitus
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2015-07-13; Completion date: 2016-11-25
Enrollment: 380 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil (AZM) in Asian adult participants with both essential hypertension and type 2 diabetes.

Detailed description:
The drug being tested in this study is called azilsartan medoxomil. Azilsartan medoxomil is being tested to treat people who have essential hypertension and type 2 diabetes mellitus (T2DM). This study will look at the blood pressure of people who take azilsartan medoxomil in addition to standard care for T2DM.

The study will enroll approximately 380 patients. All participants will receive azilsartan medoxomil 40 mg tablets to be administered orally, once a day, for 12 weeks. If a participant's blood pressure (BP) has not reached BP goal of \<140/85 mmHg at week 6, azilsartan medoxomil dose will be up-titrated to 80 mg daily.

All participants will be asked to take one tablet at the same time each day throughout the study.

This multi-center trial will be conducted in Asia. The overall time to participate in this study is 14 weeks. Participants will make multiple visits to the clinic, and will be contacted by 14 days after last dose of study drug for a follow-up assessment.

Arms: arm 1: Azilsartan medoxomil 40 mg, tablets, orally, once, daily, for 12 weeks. Azilsartan medoxomil dose may be increased to 80 mg once daily if blood pressure has not reach BP goal of \<140/85 mmHg at Week 6.
Interventions: intervention 1: Azilsartan Medoxomil
Intervention descriptions: intervention 1: Azilsartan medoxomil tablets

Protocol documents:
Clinical trial NCT02577003
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2015-11-09; Completion date: 2016-11-25
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to assess the safety and efficacy of the addition of ipragliflozin once daily in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on sitagliptin, diet, and exercise therapy. The primary hypothesis for this study is that the addition of ipragliflozin compared with placebo provides greater reduction in hemoglobin A1C (HbA1c) as assessed by change from baseline at Week 24.

Detailed description:

Arms: arm 1: Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise. arm 2: Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
Interventions: intervention 1: Ipragliflozin intervention 2: Placebo intervention 3: Sitagliptin
Intervention descriptions: intervention 1: 50 mg tablet administered orally intervention 2: Placebo to ipragliflozin tablet administered orally intervention 3: Background medication; 50 mg tablet administered orally

Protocol documents:
Clinical trial NCT02875080
Conditions: Healthy Adult Male
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2016-09-27; Completion date: 2016-11-27
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The ratios of the geometric means of the ODT formulation to those of the reference formulation (conventional tablet) for the bioavailability variables (Cmax, AUCt, and AUC∞ of brexpiprazole (OPC-34712)).

Detailed description:

Arms: arm 1: OPC-34712 (4 mg) orally disintegrating tablet is administered with water. arm 2: OPC-34712 (4 mg) orally disintegrating tablet is administered without water. arm 3: OPC-34712 (4 mg) conventional tablet is administered with water.
Interventions: intervention 1: OPC-34712
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00988208
Conditions: Prostate Cancer
Keywords: Castrate-Resistant Prostate Cancer Revlimid Lenalidomide
Sponsor: Celgene
Start date: 2009-11-11; Completion date: 2016-11-28
Enrollment: 1059 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether lenalidomide is safe and effective for use in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer.

The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects.

Detailed description:
In November 2011, the Data Monitoring Committee concluded it was unlikely that the study would meet its primary endpoint of overall survival (OS) and recommended that the study be stopped. The study was terminated in accordance with this recommendation. All sites were instructed to immediately discontinue all patients from experimental lenalidomide/placebo treatment administered either in combination with chemotherapy or as a single agent following chemotherapy discontinuation. Subsequently, Protocol Amendment 3 was issued to provide for the following:

To continue to collect information on Second Primary Malignancies (SPMs) and additional treatments for Prostate Cancer in all randomized subjects during survival follow-up.

To continue to provide docetaxel and prednisone for up to 10 cycles to subjects randomized at non-US sites who were ongoing in the CC-5013-PC-002 protocol when the decision was made to discontinue lenalidomide/placebo and who were experiencing benefit as per investigator discretion. For subjects who had exceeded 10 cycles of docetaxel and prednisone at the time of Protocol Amendment 3 approval, an additional two cycles were provided.

All references to dosing and study procedures pertaining to the safety, efficacy, and exploratory endpoints of lenalidomide/placebo were discontinued as part of Protocol Amendment 3.

Arms: arm 1: 25 mg lenalidomide orally once each day on Days 1-14; 75 mg/m2 docetaxel intravenously on Day 1; 5 mg prednisone orally twice daily on each day of the treatment cycle arm 2: Oral placebo once each day on Days 1-14 of the treatment cycle; 75 mg/m2 docetaxel intravenously on Day 1; 5 mg prednisone orally twice each day on each day of the treatment cycle
Interventions: intervention 1: Lenalidomide intervention 2: Docetaxel intervention 3: Prednisone intervention 4: Placebo
Intervention descriptions: intervention 1: 25 mg lenalidomide orally once each day on Days 1-14 intervention 2: 75 mg/m2 intravenous docetaxel on Day 1 intervention 3: 5 mg prednisone orally twice daily on each day of the treatment cycle intervention 4: Oral placebo once each day on Days 1-14 of the treatment cycle

Protocol documents:
Clinical trial NCT01901653
Conditions: Recurrent Small Cell Lung Cancer
Keywords: Small cell lung cancer
Sponsor: Stemcentrx
Start date: 2013-07-01; Completion date: 2016-11-28
Enrollment: 82 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and tolerability of rovalpituzumab tesirine (SC16LD6.5) at different dose levels in patients with small cell lung cancer whose cancer has progressed or recurred following standard chemotherapy. Once a safe and tolerable dose is determined, the anti-cancer activity of SC16LD6.5 will be assessed by measuring the extent of tumor shrinkage. SC16LD6.5 is an antibody-drug conjugate (ADC). The antibody (SC16) targets a protein that appears to be expressed on the surface of most small cell lung cancers that have been assessed using an immunohistochemical assay. The drug, D6.5, is a very potent form of chemotherapy, specifically a DNA-damaging agent, that is cell cycle independent. ADC's theoretically provide more precise delivery of chemotherapy to cancer cells, possibly improving effectiveness relative to toxicities.

Detailed description:

Arms: arm 1: Rovalpituzumab tesirine will be administered as a single agent, at increasing dose levels as permitted based on real-time assessment of safety and tolerability, intravenously over 30 minutes. Doses will be repeated on Day 1 of each 21-day or 42-day cycle until either unacceptable toxicity or evidence of disease progression occurs.
Interventions: intervention 1: Rovalpituzumab tesirine (SC16LD6.5)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02522104
Conditions: Sickle Cell Disease Renal Function Disorder
Keywords: Pharmacokinetics of Hydroxyurea
Sponsor: Theravia
Start date: 2015-09-03; Completion date: 2016-11-28
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The use of hydroxyurea in sickle cell disease patients with glomerular hyperfiltration and renal failure requires a specific monitoring and dose adjustment in order to remain within the therapeutic interval while limiting the risk of toxicity or therapeutic failure. For this reason the investigators propose to compare the pharmacokinetic parameters of hydroxyurea in normal-renal function sickle cell patients to those of patients with glomerular hyperfiltration or moderate renal failure.

Detailed description:

Arms: arm 1: Normal-renal function: 90 ≤ GFR ≤ 130 mL/min/1.73m2 in women or 140 mL/min/1.73m2 in men arm 2: Glomerular renal hyperfiltration: GFR \> 130 mL/min/1.73m2 in women and GFR \> 140 mL/min/1.73m2 in men. arm 3: Moderate renal failure: 30 ≤ GFR ≤ 60 mL/min/1.73m2
Interventions: intervention 1: Siklos
Intervention descriptions: intervention 1: None

Protocol documents: