ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01156792
Conditions: Asthma
Keywords: asthma GSK2190915
Sponsor: GlaxoSmithKline
Start date: 2010-09-01; Completion date: 2011-10-01
Enrollment: 162 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 100mg, GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate 100mcg inhalation administered twice daily in uncontrolled asthmatic subjects \> or = 12 years of age over the course of 6 weeks treatment.

The secondary objectives are to undertake an exploratory analysis of the efficacy and safety of adding montelukast 10mg administered once daily or salmeterol 50mcg administered twice daily to fluticasone propionate 100mcg inhalation administered twice daily and to investigate the pharmacokinetics and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects \> or = 12 years of age over the course of 6 weeks treatment.

Detailed description:

Arms: arm 1: FP 100mcg BID plus GSK2190915 100mg QD (AM) arm 2: FP 100mcg BID plus GSK2190915 300mg QD (AM) arm 3: FP 100mcg BID plus montelukast 10mg QD (PM) arm 4: FP 100mcg BID plus placebo BID arm 5: FP/SAL 100/50mcg BID plus placebo BID
Interventions: intervention 1: FP 100 intervention 2: GSK2190915 100 intervention 3: GSK2190915 300 intervention 4: montelukast intervention 5: placebo intervention 6: FP/SAL 100/50
Intervention descriptions: intervention 1: FP 100mcg BID intervention 2: GSK2190915 100mg QD (AM) intervention 3: GSK2190915 300mg QD (AM) intervention 4: montelukast 10mg QD (PM) intervention 5: placebo BID intervention 6: FP/SAL 100/50mcg BID

Protocol documents:
Clinical trial NCT01161498
Conditions: Squamous Cell Carcinoma Head and Neck Cancer
Keywords: squamous cell OncoVEX^GM-CSF Oncovex chemoradiation Cisplatin
Sponsor: BioVex Limited
Start date: 2011-02-01; Completion date: 2011-10-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to learn about the safety and risks of using talimogene laherparepvec to treat patients with head and neck cancer and to see if talimogene laherparepvec and chemoradiation together can destroy the tumours versus the use of chemoradiation alone. This study may provide information on the usefulness of talimogene laherparepvec combined with chemoradiation as a future treatment for head and neck cancer.

Detailed description:
The objective is to evaluate the efficacy and safety of treatment with chemoradiation (CRT) plus talimogene laherparepvec compared to CRT alone in previously untreated patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) for which surgical resection is not clinical indicated. The efficacy endpoints of the study aim to demonstrate overall clinical benefit for patients treated with talimogene laherparepvec as compared to CRT alone.

Arms: arm 1: Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period. arm 2: The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ plaque-forming units (PFU)/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
Interventions: intervention 1: Talimogene Laherparepvec intervention 2: Radiation intervention 3: Cisplatin
Intervention descriptions: intervention 1: Administered by intratumoral injection intervention 2: 70 grays of radiation administered in 35 fractions over 7 weeks intervention 3: Administered by intravenous infusion

Protocol documents:
Clinical trial NCT01171924
Conditions: Head and Neck Cancer Liver Cancer Breast Cancer Gastric Cancer Non-Small Cell Lung Cancer
Keywords: Head and Neck Cancer Liver Cancer Breast Cancer Gastric Cancer Non-Small Cell Lung Cancer EGFR HDAC Her2 CUDC-101
Sponsor: Curis, Inc.
Start date: 2010-07-01; Completion date: 2011-10-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase Ib open label, expansion study of CUDC-101 in patients with advanced head and neck, gastric, breast, liver, and non-small cell lung cancer tumors. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2 (Her2) and histone deacetylase (HDAC). The study is designed to compare the safety and tolerability of CUDC-101 when administered at the maximum tolerated dose on either a 5 days/week schedule or a 3 days/week schedule.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CUDC-101 intervention 2: CUDC-101
Intervention descriptions: intervention 1: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle. intervention 2: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.

Protocol documents:
Clinical trial NCT01172652
Conditions: Bipolar Disorder Panic Disorder Generalized Anxiety Disorder
Keywords: Bipolar disorder Anxiety Panic GAD Generalized Anxiety Disorder
Sponsor: VA Palo Alto Health Care System
Start date: 2010-04-01; Completion date: 2011-10-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The specific aim of this study is to evaluate the efficacy, tolerability, and safety of ziprasidone monotherapy in comparison to placebo in the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.

Detailed description:
This is a randomized, double-blind, placebo controlled, parallel-group, 8-week trial of ziprasidone compared to placebo in outpatient subjects with a lifetime bipolar I, II, or NOS disorder, a lifetime panic or generalized anxiety disorder, and current diagnosis at least moderately severe anxiety symptoms. Approximately 50 subjects will be randomized. Subjects will be randomized to ziprasidone or placebo in a 1:1 ratio. No concomitant psychotropic medication will be allowed throughout the study except for prn lorazepam during the first two weeks for the management of affective and anxiety symptoms, prn zolpidem and zaleplon for the management of insomnia and benztropine for the management of EPS. Throughout the study, psychiatric scales will be used to assess psychiatric symptoms and the presence of treatment-emergent adverse events will be monitored and recorded.

Arms: arm 1: Ziprasidone in the form of 40 and/or 80 mg capsules. Dose range: 40 to 160 mg/day. arm 2: Administered in capsules identical to the ziprasidone capsules.
Interventions: intervention 1: Ziprasidone intervention 2: Placebo
Intervention descriptions: intervention 1: The minimum dose during study participation will be 40 mg/day, and the maximum dose allowed will be 160 mg/day. intervention 2: Inactive control

Protocol documents:
Clinical trial NCT01194830
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2010-09-01; Completion date: 2011-10-01
Enrollment: 234 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study of linagliptin vs. placebo in Black/African American patients with T2DM with a MTT sub-study

Detailed description:

Arms: arm 1: 1 Tablet PO QD arm 2: 1 Tablet PO QD
Interventions: intervention 1: Linagliptin intervention 2: Placebo
Intervention descriptions: intervention 1: Active drug 1 tablet PO QD intervention 2: 1 Tablet PO QD

Protocol documents:
Clinical trial NCT01225354
Conditions: Malar Deficiency
Keywords: Cheek Cheek flattening Malar deficiency Filler
Sponsor: DeNova Research
Start date: 2010-08-01; Completion date: 2011-10-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if Radiesse injections to the cheeks result in an altered and improved first impression and self esteem.

Detailed description:

Arms: arm 1: Subject will be treated at baseline and, if needed, at 2 weeks.
Interventions: intervention 1: Calcium hydroxylapatite
Intervention descriptions: intervention 1: Subjects will be treated to full correction at visit 1 and, if needed, a touch-up injection at 2 weeks.

Protocol documents:
Clinical trial NCT01229410
Conditions: Vitrectomy
Sponsor: Allergan
Start date: 2010-12-01; Completion date: 2011-10-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the pharmacokinetics of brimonidine following a single intravitreal administration of the 200 ug or 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery System in patients 2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy.

Detailed description:

Arms: arm 1: 400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy). arm 2: 200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
Interventions: intervention 1: 400 µg Brimonidine Tartrate Implant intervention 2: 200 µg Brimonidine Tartrate Implant
Intervention descriptions: intervention 1: 400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy). intervention 2: 200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).

Protocol documents:
Clinical trial NCT01237821
Conditions: Acne Vulgaris
Sponsor: Milton S. Hershey Medical Center
Start date: 2010-10-01; Completion date: 2011-10-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research is being done to find out the safety and efficacy of two acne creams, Effaclar and Benzaclin when used twice daily with a topical retinoid. Effaclar and Benzaclin are FDA approved for the treatment of acne.

Detailed description:
There are many products on the market to treat facial acne. The medication that this study will be evaluating, Benzaclin and Retin-A have been approved by the FDA and is available by prescription, Effaclar is an over the counter product. This study will hopefully recognize a treatment combination that is effective in reducing acne vulgaris in adults 18-50.

Arms: arm 1: Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.Inclusion- males and females ages 18-50, mild to moderate acne vulgaris with \> or equal to 15 inflammatory lesions, \> or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or tanning beds throughout the study, . Exclusion- Participants who have another skin condition that will interfere with lesion counting or assessments arm 2: Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.Inclusion- males and females ages 18-50, mild to moderate acne vulgaris with \> or equal to 15 inflammatory lesions, \> or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or tanning beds throughout the study, . Exclusion- Participants who have another skin condition that will interfere with lesion counting or assessments
Interventions: intervention 1: BenzaClin intervention 2: Effaclar
Intervention descriptions: intervention 1: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks intervention 2: Topical, Bid, 12 weeks

Protocol documents:
Clinical trial NCT01248936
Conditions: Malignant Melanoma
Sponsor: Hoffmann-La Roche
Start date: 2010-12-01; Completion date: 2011-10-01
Enrollment: 374 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, non-comparative, multicenter, expanded access study of RO5185426 in patients who have received prior systemic therapy for metastatic melanoma and who have no other satisfactory treatment options.

Detailed description:

Arms: arm 1: Participants received vemurafenib 960 milligram (mg) orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
Interventions: intervention 1: RO5185426
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01252095
Conditions: Advanced Solid Tumours
Keywords: PG545 Phase I Progen antimetastatic antiangiogenic advanced cancer patients solid tumors solid tumours
Sponsor: Zucero Pty Ltd
Start date: 2011-01-01; Completion date: 2011-10-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This first-in-human study aims to establish the maximum tolerated dose of PG545 and to evaluate its safety in subjects with advanced solid tumours. In addition the study will explore whether PG545 exposure results in changes to chemicals produced by the body that are associated with cancer growth and spread.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: PG545
Intervention descriptions: intervention 1: PG545 Lyophilized Powder for Subcutaneous Injection. Patients will be dosed once weekly until they exhibit disease progression, are discontinued for reasons of tolerability, or the study reaches its defined end-point. This study is a dose escalation study with doses of 25 mg to 500 mg planned.

Protocol documents:
Clinical trial NCT01253525
Conditions: Adenocarcinoma
Keywords: Adenocarcinoma Gastroesophageal Junction
Sponsor: Eli Lilly and Company
Start date: 2010-11-01; Completion date: 2011-10-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Investigate the safety and tolerability of ramucirumab (IMC-1121B) drug product (DP) in combination with paclitaxel.

Detailed description:

Arms: arm 1: Each treatment cycle is 4 weeks (28 days)
Interventions: intervention 1: Ramucirumab (IMC-1121B ) intervention 2: Paclitaxel
Intervention descriptions: intervention 1: 8 milligrams/kilogram (mg/kg) intravenously on Days 1 and 15 of each 28-ay cycle intervention 2: 80 milligram/square meter (mg/m2) intravenously Days 1, 8, and 15 of each 28 day cycle

Protocol documents:
Clinical trial NCT01253902
Conditions: Glaucoma, Open-Angle Ocular Hypertension
Sponsor: Allergan
Start date: 2010-12-01; Completion date: 2011-10-01
Enrollment: 164 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the ocular surface tolerability of the prostaglandin analogues bimatoprost ophthalmic solution 0.01% (Lumigan® 0.01%), travoprost ophthalmic solution 0.004% (Travatan Z®) and latanoprost ophthalmic solution 0.005% (Xalatan®) in patients previously treated with Xalatan® who have open-angle glaucoma or ocular hypertension.

Detailed description:

Arms: arm 1: One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks. arm 2: One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks. arm 3: One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
Interventions: intervention 1: bimatoprost ophthalmic solution 0.01% intervention 2: travoprost ophthalmic solution 0.004% intervention 3: latanoprost ophthalmic solution 0.005%
Intervention descriptions: intervention 1: One drop of bimatoprost ophthalmic solution 0.01% administered to affected eye(s), once daily in the evening for 12 weeks. intervention 2: One drop of travoprost ophthalmic solution 0.004% administered to affected eye(s), once daily in the evening for 12 weeks. intervention 3: One drop of latanoprost ophthalmic solution 0.005% administered to affected eye(s), once daily in the evening for 12 weeks.

Protocol documents:
Clinical trial NCT01265511
Conditions: Hepatitis C Infection
Keywords: Hepatitis C SCY-635 Ribavirin Interferon
Sponsor: Scynexis, Inc.
Start date: 2010-11-01; Completion date: 2011-10-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the effectiveness of 28 days of triple combination therapy including SCY-635 with peginterferon alfa 2a and ribavirin in reducing serum HCV RNA levels. An additional 20 weeks of treatment with the currently approved standard of care will be offered to all participants. The Week 24 visit will be the last on-study visit. After the Week 24 visit, all subjects with undetectable HCV RNA will be given the option to continue treatment with standard of care for an additional 24 weeks (out to Week 48) under the care of their Principal Investigator.

Detailed description:
Objectives:

The primary objective of this Phase 2a study was to assess the effect of treatment with SCY-635, used in combination with peginterferon alfa-2a (PegIFN α-2a) and ribavirin (RBV), on hepatitis C viral replication (as measured by quantitative serum HCV RNA) in treatment-naive subjects with chronic genotype 1 infection who have an IL28B genotype of C/T or T/T.

The secondary objective of the study was to evaluate the safety and pharmacokinetics (PK) of SCY-635 when given in combination with PegIFN α-2a and RBV.

Primary Endpoints:

Proportion of subjects in each cohort with an undetectable serum HCV RNA level at Week 4 of treatment

Secondary Endpoints:

Adverse events and clinical laboratory assessments, including tests of liver function Proportion of subjects achieving complete early virologic response (cEVR, defined as an undetectable serum HCV RNA level at Week 12) Proportion of subjects achieving partial early virologic response (pEVR, defined as a detectable serum HCV RNA level with ≥ 2 log10 reduction in serum HCV RNA from Baseline to Week 12) Proportion of subjects achieving an undetectable serum HCV RNA level at Week 24 Pharmacokinetic assessments of SCY-635 when given in combination with PegIFN α-2a and RBV; trough concentrations of PegIFN α-2a and RB

Arms: arm 1: Placebo + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks arm 2: SCY-635 600 mg + PegIFN + RBV for 4 weeks followed by PegIFN + RBV for 20 weeks
Interventions: intervention 1: Placebo intervention 2: SCY-635 intervention 3: Pegasys intervention 4: Copegus
Intervention descriptions: intervention 1: Oral tablets given bid for 28 days intervention 2: SCY-635 tablets, 300 mg bid for 28 days intervention 3: 180 ug prefilled syringe given once per week for up to 48 weeks intervention 4: tablets given bid for up to 48 weeks

Protocol documents:
Clinical trial NCT01276054
Conditions: Lymphedema Recurrent Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer
Sponsor: University of Southern California
Start date: 2010-12-01; Completion date: 2011-10-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Lymph node biopsy followed by axillary reverse mapping may reduce the incidence and severity of arm lymphedema. This randomized phase II trial is studying how well sentinel and/or axillary lymph node biopsy with or without axillary reverse mapping works in reducing incidence and severity of lymphedema in patients with resectable stage 0-II breast cancer

Detailed description:
PRIMARY OBJECTIVES: I. To evaluate the ability of axillary reverse mapping (ARM) to reduce the incidence of lymphedema (LE) following axillary nodal staging. SECONDARY OBJECTIVES: I. To document the use of a standardized LE screening and LE level-specific management protocol on the outcome of LE among patients who develop LE. II. To document the relationship between limb volume measurements assessed by infrared laser perometry and bioelectrical impedance spectroscopy. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo and axillary reverse mapping. ARM II: Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. After completion of study treatment, patients are followed up at 1-2 weeks, 3 months, and then every 6 months for 4 years.

Arms: arm 1: Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping. arm 2: Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.
Interventions: intervention 1: technetium Tc 99m sulfur colloid intervention 2: methylene blue intervention 3: indocyanine green solution intervention 4: sentinel lymph node biopsy intervention 5: axillary lymph node biopsy intervention 6: bioimpedance spectroscopy intervention 7: quality-of-life assessment intervention 8: lymphedema management
Intervention descriptions: intervention 1: Given intradermally and periareolarly intervention 2: Given subcutaneously intervention 3: Given subcutaneously intervention 4: Undergo sentinel lymph node biopsy intervention 5: Undergo axillary lymph node biopsy intervention 6: Correlative studies intervention 7: Ancillary studies intervention 8: Undergo axillary reverse mapping

Protocol documents: