ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01474590
Conditions: Acne
Sponsor: Galderma R&D
Start date: 2011-11-01; Completion date: 2013-08-01
Enrollment: 266 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Non-inferiority, randomized, controlled, multi-center, investigator-blind, parallel-group comparison study in subjects with severe acne vulgaris on the face.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Epiduo/Tactuo intervention 2: vehicle gel intervention 3: doxycycline 200mg intervention 4: Isotretinoin
Intervention descriptions: intervention 1: topical to the face, once daily in the evening intervention 2: topical to the face, once daily in the evening intervention 3: oral, 2 capsules once daily in the morning with aglass of water and with food intervention 4: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.

Protocol documents:
Clinical trial NCT01480076
Conditions: Multiple Sclerosis
Keywords: Quality of Life Multiple Sclerosis
Sponsor: Biogen
Start date: 2012-02-01; Completion date: 2013-08-01
Enrollment: 901 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study is to assess the effect of long-term treatment with prolonged-release fampridine (BIIB041) 10 mg twice daily on the physical component scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) as reported by treatment responders. The secondary objectives of this study are to compare the change in the PCS of the SF-36 between treatment responders and non-responders, to evaluate change from baseline in additional quality of life measures among treatment responders as well as changes from baseline in treatment responders versus non-responders and to assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily.

Detailed description:
This study has 2 components: a 4-week run-in period during which participants are treated with prolonged-release fampridine and undergo subjective and objective assessments of walking ability, the results of which are used to determine who responded to study treatment, and an observational period, during which treatment responders will continue prolonged-release fampridine treatment. The participants who do not meet the criteria to continue study treatment will be offered the opportunity to continue study participation but will not continue prolonged-release fampridine treatment.

Arms: arm 1: All participants take 10 mg fampridine twice daily for the first 4 weeks. If deemed a treatment responder, a participant continues 10 mg fampridine twice daily for 44 weeks. Treatment non-responders can continue without treatment by completing quality of life questionnaires.
Interventions: intervention 1: Fampridine
Intervention descriptions: intervention 1: Supplied as a 10 mg twice daily tablet and taken twice daily. Doses must be spaced at least 12 hours apart.

Protocol documents:
Clinical trial NCT01493687
Conditions: Papulopustular Rosacea (PPR)
Sponsor: Galderma R&D
Start date: 2011-12-01; Completion date: 2013-08-01
Enrollment: 683 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.

Detailed description:

Arms: arm 1: CD5024 1% Cream arm 2: CD5024 Vehicle Cream
Interventions: intervention 1: CD5024 intervention 2: Azelaic acid 15% Gel
Intervention descriptions: intervention 1: CD5024 1% Cream, once daily intervention 2: Topical Gel applied twice daily

Protocol documents:
Clinical trial NCT01494467
Conditions: Papulopustular Rosacea
Keywords: PPR
Sponsor: Galderma R&D
Start date: 2011-12-01; Completion date: 2013-08-01
Enrollment: 688 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.

Detailed description:

Arms: arm 1: CD5024 1% Cream arm 2: CD5024 Vehicle Cream
Interventions: intervention 1: CD5024 intervention 2: Azelaic acid 15% Gel
Intervention descriptions: intervention 1: CD5024 1% Cream, once daily intervention 2: Topical Gel applied twice daily

Protocol documents:
Clinical trial NCT01494987
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Sponsor: Gilead Sciences
Start date: 2012-01-01; Completion date: 2013-08-01
Enrollment: 431 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to determine the effect of ranolazine when added to glimepiride on glycemic control in adults with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment with stable sulfonylurea or metformin therapy in addition to diet and exercise.

Detailed description:

Arms: arm 1: Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride will receive glimepiride 2 mg once daily, and if tolerated the dose will be increased on Day 8 (+ 2 days) to 4 mg once daily.

Qualifying period: participants will receive placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria will continue to the treatment period.

Treatment period: participants will be randomized to receive ranolazine 500 mg twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.

Participants will be required to maintain their diet and exercise regimen. arm 2: Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride will receive glimepiride 2 mg once daily, and if tolerated the dose will be increased on Day 8 (+ 2 days) to 4 mg once daily.

Qualifying period: participants will receive placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria will continue to the treatment period.

Treatment period: participants will be randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.

Participants will be required to maintain their diet and exercise regimen.
Interventions: intervention 1: Ranolazine intervention 2: Placebo intervention 3: Glimepiride intervention 4: Diet intervention 5: Exercise
Intervention descriptions: intervention 1: Ranolazine tablet(s) administered orally intervention 2: Placebo to match ranolazine for the duration of the study intervention 3: Glimepiride tablets (2 mg or 4 mg) administered orally once daily with the morning dose of study drug or placebo. The target dosing regimen for glimepiride is 4 mg once daily. intervention 4: Participants are instructed to continue the diet regimen prescribed by their physician. intervention 5: Participants are instructed to continue the exercise regimen prescribed by their physician.

Protocol documents:
Clinical trial NCT01508936
Conditions: Eosinophilic Asthma
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2012-02-01; Completion date: 2013-08-01
Enrollment: 511 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to characterize the efficacy of reslizumab treatment, at a dosage of 3.0 milligrams per kilogram (mg/kg) every 4 weeks for a total of 4 doses, in improving pulmonary function in relation to baseline blood eosinophil levels in patients with moderate to severe asthma, as assessed by the change from baseline to week 16 in forced expiratory volume in 1 second (FEV1).

Detailed description:

Arms: arm 1: Placebo intravenous injection every 4 weeks for a total of 4 doses. arm 2: Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
Interventions: intervention 1: Reslizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Reslizumab administered at a dosage of 3.0 mg/kg by intravenous (iv) infusion by qualified study personnel every 4 weeks for 16 weeks (for a total of 4 doses). intervention 2: Matching placebo administered by intravenous (iv) infusion by qualified study personnel every 4 weeks for 16 weeks (for a total of 4 doses).

Protocol documents:
Clinical trial NCT01513122
Conditions: HIV
Sponsor: Kirby Institute
Start date: 2010-02-01; Completion date: 2013-08-01
Enrollment: 210 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The use of anti HIV drugs (ART), and in particular a class of drugs known as nucleoside reverse transcriptase inhibitors (N(t)RTI), has been associated with changes in body fat and in particular loss of peripheral fat in the limbs. Low bone mineral density and osteoporosis are also common in HIV-infected patients. There appears to be some association between ART and bone loss, but this is poorly understood and requires further research. The SECOND-LINE study provides an opportunity to examine if a new anti-HIV drug (raltegravir) can result in greater increase in limb fat than a drug regimen containing N(t)RTI, which is currently standard of care. This study also provides an opportunity to examine if additional bone loss occurs with the second regimen of anti-HIV drugs and whether non-N(t)RTI regimens of ART used in second line therapy result in more or less bone loss than use of other classes of anti-HIV drugs such as protease inhibitors or N(t)RTI combinations.

It is hypothesized that subjects randomised into Raltegravir arm will demonstrate greater increases in limb fat and smaller reductions in bone density at the proximal femur over 48 weeks than those randomised into the control arm (LPV/r + 2-3N(t)RTIs).

Detailed description:

Arms: arm 1: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3N(t)RTI arm 2: None
Interventions: intervention 1: Lopinavir / ritonavir intervention 2: 2-3N(t)RTI intervention 3: raltegravir
Intervention descriptions: intervention 1: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily intervention 2: None intervention 3: raltegravir 400mg 1 tablet twice daily.

Protocol documents:
Clinical trial NCT01514422
Conditions: Bipolar Depression
Keywords: Bipolar disorder depression minocycline mood disorders bipolar depression
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2011-05-01; Completion date: 2013-08-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate minocycline as a potential treatment for bipolar depression when added to a mood-stabilizing medication. Minocycline is an antibiotic that is approved for the treatment of infections and acne. Participation in this research study is expected to last 8 weeks, and includes five outpatient visits.

Detailed description:
Bipolar depression remains the great unmet need in the treatment of bipolar disorder. Only two treatments have been FDA-approved for the management of acute bipolar depression (the combination of olanzapine and fluoxetine and quetiapine). Early pilot data suggests the drug minocycline has potent antidepressant effects. Minocycline is approved by the Food and Drug Administration (FDA) (for acne and bacterial infections), is inexpensive and readily available in generic formulation, and is generally well-tolerated. This study will examine whether administering the drug minocycline to individuals with bipolar depression over 8 weeks will improve their depressive symptoms. This study will also offer an option to participate in proton magnetic resonance spectroscopy (1H-MRS) to measure N-Acetylaspartate (NAA) levels in the brain, which are thought to be decreased in bipolar disorder.

Arms: arm 1: All subjects will be given minocycline over 8 weeks
Interventions: intervention 1: Minocycline
Intervention descriptions: intervention 1: Minocycline 100 to 300mg per day for 8 weeks

Protocol documents:
Clinical trial NCT01526577
Conditions: Acute Coronary Syndrome
Keywords: phase1 healthy subjects antiplatelet agent
Sponsor: LG Life Sciences
Start date: 2012-03-01; Completion date: 2013-08-01
Enrollment: 113 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be a dose block-randomized, double-blind, active and placebo controlled, single and multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic/pharmacodynamic characteristics. Adverse events, physical examinations, vital signs, ECG and laboratory tests will be conducted for safety/tolerability evaluation and serial blood samples and urine collections for pharmacokinetic and pharmacodynamic evaluations will be conducted at specified time points.

Detailed description:

Arms: arm 1: experimental drug arm 2: LC23-1306 placebo arm 3: active comparator
Interventions: intervention 1: LC23-1306 intervention 2: placebo intervention 3: Ticagrelor
Intervention descriptions: intervention 1: LC23-1306 10, 30, 100, 200, 400, 600 mg Placebo 10, 30, 100, 200, 400, 600 mg intervention 2: LC23-1306 placebo intervention 3: Ticagrelor 90mg

Protocol documents:
Clinical trial NCT01528735
Conditions: Hepatitis C, Chronic
Sponsor: Boehringer Ingelheim
Start date: 2012-02-01; Completion date: 2013-08-01
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this trial is to investigate tolerability, safety, pharmacokinetics and antiviral activity of BI 207127 NA in combination with BI 201335 NA and ribavirin for 8 weeks in Japanese treatment-naive patients with chronic GT-1 HCV infection.

Detailed description:

Arms: arm 1: Patients receive BI 207127 NA,BI 201335 NA(high dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks arm 2: Patients receive BI 207127 NA,BI 201335 NA(low dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks
Interventions: intervention 1: BI 207127 NA intervention 2: peginterferon intervention 3: Ribavirin intervention 4: Ribavirin intervention 5: BI 207127 NA intervention 6: BI 201335 NA intervention 7: BI 201335 NA intervention 8: peginterferon
Intervention descriptions: intervention 1: one fix dose intervention 2: per package insert intervention 3: per weight BID intervention 4: per weight BID intervention 5: one fix dose intervention 6: high dose intervention 7: low dose intervention 8: per package insert

Protocol documents:
Clinical trial NCT01529450
Conditions: Basal Cell Carcinoma
Keywords: basal cell carcinoma, sonidegib, smoothened inhibitor, hedgehog
Sponsor: Anne Chang
Start date: 2012-02-01; Completion date: 2013-08-01
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective single-center, open label, pilot study to investigate the safety and efficacy of LDE225 in patients with locally advanced or metastatic basal cell carcinoma.

Primary Objectives:

• To explore the effects of oral LDE225 on the Progression Free Survival (PFS) of individuals with locally advanced or metastatic BCC who have been previously treated with a non-LDE225 Smo inhibitor.

Secondary Objectives:

* To evaluate the effect of oral LDE225 on tumor tissue biomarkers of BCC activation (Gii 1, 2, Patched 1,2 and Ki67) in individuals which are non-na"ive to Smo inhibitors other than LDE225, at baseline and at end-of-treatment
* To describe adverse effects of oral LDE225 in individuals with a history of non-LDE225 Smo inhibitor usage
* To assess the overall survival rates of individuals with locally advanced BCC or metastatic BCC who have previously taken a non-LDE225 Smo inhibitor after treatment with LDE225

Detailed description:
This is a prospective single-center, open label, pilot study to investigate the safety and efficacy of LDE225 in patients with locally advanced or metastatic basal cell carcinoma.

Primary Objectives:

• To explore the effects of oral LDE225 on the Progression Free Survival (PFS) of individuals with locally advanced or metastatic BCC who have been previously treated with a non-LDE225 Smo inhibitor.

Secondary Objectives:

* To evaluate the effect of oral LDE225 on tumor tissue biomarkers of BCC activation (e.g. Gli and Ki67) in individuals which are non-naive to Smo inhibitors other than LDE225, at baseline and at end-of-treatment
* To describe adverse effects of oral LDE225 in individuals with a history of non-LDE225 Smo inhibitor usage

Arms: arm 1: Patients previously treated with non-LDE225 Smo inhibitor who were refractory. arm 2: Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.
Interventions: intervention 1: LDE225
Intervention descriptions: intervention 1: 800-mg (4 200-mg capsules/day) capsule

Protocol documents:
Clinical trial NCT01542034
Conditions: Moderate or Severe Submental Fullness
Sponsor: Kythera Biopharmaceuticals
Start date: 2012-02-01; Completion date: 2013-08-01
Enrollment: 506 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

Detailed description:

Arms: arm 1: Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. arm 2: Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Interventions: intervention 1: Deoxycholic acid injection intervention 2: Placebo
Intervention descriptions: intervention 1: Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL. intervention 2: Phosphate buffered saline placebo for injection

Protocol documents:
Clinical trial NCT01545518
Conditions: Epilepsy, Cryptogenic Epilepsy, Partial Seizure Disorder Autoimmune Diseases, Nervous System Limbic Encephalitis
Keywords: Refractory epilepsy Cryptogenic epilepsy Autoimmune disorders IVIG Immunomodulatory therapy Autoantibodies
Sponsor: Emory University
Start date: 2011-11-01; Completion date: 2013-08-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the initial screening study is to find out if immune problems are an unrecognized cause of epilepsy in some patients. This study consists of a single blood sample, which will be tested for possible immune abnormalities. If enough patients are found who show immune abnormalities, those patients who are still having uncontrolled seizures will be invited to participate in a study of immune treatment with a compound called intravenous immunoglobulin (IVIG).

The study hypothesis is that a significant proportion of the young-onset, refractory, image-negative, partial-onset epilepsy population have an underlying autoimmune disorder, and many of these patients will respond to immune therapies, including IVIG.

At present, the importance of immune abnormalities in causing epilepsy, and the proper treatment when they are found, are both poorly understood. The investigators hope that this study will help us understand the cause of some cases that are difficult to treat.

Detailed description:
The study is divided into two phases:

Phase I: The investigators will screen for evidence of neuronal nuclear, cytoplasmic, and cell surface autoantibodies in our population of new onset refractory, imaging-negative young adult epilepsy patients. This part of the study involves obtaining a single blood sample, equal to about 2 teaspoons.

Phase 2: If a sufficient number of cases are identified, a double-blind crossover study of IVIG treatment will be performed in these patients.

Arms: arm 1: IVIG
Interventions: intervention 1: IVIG
Intervention descriptions: intervention 1: IVIG 2 mg/kg in two divided doses with placebo crossover

Protocol documents:
Clinical trial NCT01546142
Conditions: Moderate or Severe Submental Fullness
Sponsor: Kythera Biopharmaceuticals
Start date: 2012-03-01; Completion date: 2013-08-01
Enrollment: 516 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

Detailed description:

Arms: arm 1: Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. arm 2: Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Interventions: intervention 1: Deoxycholic acid injection intervention 2: Placebo
Intervention descriptions: intervention 1: Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL. intervention 2: Phosphate buffered saline placebo for injection

Protocol documents:
Clinical trial NCT01559116
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2012-03-01; Completion date: 2013-08-01
Enrollment: 219 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC, administered once daily by the RESPIMAT Inhaler after 6 weeks of treatment.

Detailed description:

Arms: arm 1: tiotropium+olodaterol FDC low dose; 2 inhalations once daily (a.m. dosing) arm 2: tiotropium+olodaterol FDC high dose; 2 inhalations once daily (a.m. dosing) arm 3: tiotropium low dose; 2 inhalations once daily (a.m. dosing) arm 4: tiotropium high dose; 2 inhalations once daily (a.m. dosing) arm 5: one dose only; 2 inhalations once daily (a.m. dosing) arm 6: 2 inhalations once daily (a.m. dosing)
Interventions: intervention 1: tiotropium + olodaterol intervention 2: tiotropium intervention 3: olodaterol intervention 4: tiotropium intervention 5: tiotropium + olodaterol intervention 6: Placebo intervention 7: Respimat
Intervention descriptions: intervention 1: low dose + one dose only intervention 2: low dose intervention 3: one dose only intervention 4: high dose intervention 5: low dose + one dose only intervention 6: placebo matching tiotropium+olodaterol FDC intervention 7: Respimat inhaler

Protocol documents: