ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01909804
Conditions: Hepatitis C
Keywords: Hepatitis Genotype 1 Genotype 3 Treatment experienced
Sponsor: Gilead Sciences
Start date: 2013-06-01; Completion date: 2014-08-01
Enrollment: 323 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV) infection.

Detailed description:

Arms: arm 1: Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg for 12 weeks. arm 2: Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks. arm 3: Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg for 12 weeks. arm 4: Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks. arm 5: Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg for 12 weeks. arm 6: Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks. arm 7: Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg for 12 weeks. arm 8: Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks. arm 9: Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks. arm 10: Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 12 weeks. arm 11: Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks. arm 12: Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 12 weeks.
Interventions: intervention 1: SOF intervention 2: VEL intervention 3: RBV
Intervention descriptions: intervention 1: 400 mg tablet administered orally once daily intervention 2: Tablet administered orally once daily intervention 3: 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents:
Clinical trial NCT01910064
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Sponsor: Galderma R&D
Start date: 2013-05-01; Completion date: 2014-08-01
Enrollment: 436 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open label study is to determine the safety profile of GK530G in a long-term treatment (up to 12 months) in subjects with acne vulgaris and to evaluate the efficacy of GK530G in a long-term treatment.

Detailed description:

Arms: arm 1: GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO
Interventions: intervention 1: GK530G
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01922089
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: Heart failure, reduced ejection fraction, LCZ696, titration, safety, tolerability
Sponsor: Novartis Pharmaceuticals
Start date: 2013-11-01; Completion date: 2014-08-01
Enrollment: 498 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration regimens.

Detailed description:

Arms: arm 1: Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks arm 2: Up-titration to LCZ696 200 mg bid over 6 weeks
Interventions: intervention 1: LCZ696
Intervention descriptions: intervention 1: LCZ696 50 mg/100 mg/200 mg bid

Protocol documents:
Clinical trial NCT01922739
Conditions: Low Back Pain
Keywords: low back pain hydrocodone bitartrate opioids
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2013-07-01; Completion date: 2014-08-01
Enrollment: 182 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a 6-month, nonrandomized, open-label extension study to assess the long-term safety of hydrocodone bitartrate extended-release (ER) tablets in patients with moderate to severe chronic low back pain who require continuous opioid treatment for an extended period of time.

To be eligible for Study 3104, patients were required to have completed the entire double blind treatment period on study drug (either placebo or hydrocodone bitartrate ER tablets) through week 12 of Study 3103 (NCT01789970) and to have met the entry criteria for Study 3104.

Detailed description:
Eligible patients from Study 3103 (NCT01789970) were enrolled for participation in this extension study. For these patients, the final study visit in Study 3103 was visit 1 for this study (also referred to as the titration or adjustment baseline visit, depending on whether the patient was enrolled under the original or amended protocol, respectively). The original protocol was amended after 26 patients had been enrolled in the study. Those who were enrolled under the original protocol participated in a double-blind titration period of up to approximately 4 weeks followed by an open-label treatment period of 22 weeks. Those patients who were enrolled under the amended protocol participated in an open-label adjustment period of up to approximately 3 weeks followed by an open-label treatment period of 22 weeks.

Arms: arm 1: Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both versions of protocol 3104 followed the titration/adjustment period with a open-label treatment period of 22 weeks.
Interventions: intervention 1: Hydrocodone ER intervention 2: Placebo
Intervention descriptions: intervention 1: Participants were instructed to take hydrocodone ER tablets orally with a glass of water on an empty stomach at least 1 hour before or 2 hours after eating. intervention 2: During the double-blind titration period used in the original protocol, placebo tablets matching each dose of hydrocodone bitartrate ER tablets (active drug) were used to maintain the blind but not for purposes of comparison.

Protocol documents:
Clinical trial NCT01924949
Conditions: Hepatitis C
Keywords: 7977 5885 GS-7977 GS-5885 SOF LDV Sofosbuvir Ledipasvir FDC
Sponsor: Gilead Sciences
Start date: 2013-07-01; Completion date: 2014-08-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with nosocomial genotype 1 hepatitis C virus (HCV) infection.

Detailed description:

Arms: arm 1: Participants will receive LDV/SOF FDC for 12 weeks.
Interventions: intervention 1: LDV/SOF
Intervention descriptions: intervention 1: Ledipasvir (LDV)/sofosbuvir (SOF) 90/400 mg FDC tablet administered orally once daily

Protocol documents:
Clinical trial NCT01929109
Conditions: Kidney Failure, Chronic Renal Insufficiency, Chronic
Sponsor: Eli Lilly and Company
Start date: 2013-08-01; Completion date: 2014-08-01
Enrollment: 47 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to measure how much of the study drug, LY2409021, gets into the blood stream and how long it takes the body to get rid of it when given to participants with different levels of kidney function. There were five study groups. Each participant only enrolled in one group. Participants in groups 1 through 4 were healthy or have mild, moderate, or severe kidney disease. They completed one study period lasting about 29 days. Study group 5 enrolled participants with kidney disease who were on dialysis. They have completed two study periods which together last about 59 days. Screening was required within 21 days prior to the start of the study for all participants.

Detailed description:

Arms: arm 1: Healthy participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. arm 2: Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. arm 3: Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. arm 4: Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. arm 5: Participants received a single 80 mg dose of LY2409021 orally on Day 1 of Period 1 of the study and a single 80 mg dose of LY2409021 orally on Day 1 of Period 2 of the study.
Interventions: intervention 1: LY2409021
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT01942733
Conditions: Sleep Disturbances
Sponsor: H. Lundbeck A/S
Start date: 2013-09-01; Completion date: 2014-08-01
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To assess effects of brexpiprazole on sleep patterns of depressed patients with sleep disturbances.

Detailed description:

Arms: arm 1: Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)
Interventions: intervention 1: Brexpiprazole
Intervention descriptions: intervention 1: 2-3 mg/day, once daily, tablets, for oral use. The patients received 1mg/day brexpiprazole during Week 1 and 2mg/day during Week 2 (up-titration) and from Weeks 3 to 6 they received 3mg/day; depending on tolerability the dose could be reduced to 2mg/day based on the investigator's judgment.

Protocol documents:
Clinical trial NCT01949870
Conditions: Inoperable Locally Advanced or Metastatic Biliary Tract Cancer
Sponsor: AstraZeneca
Start date: 2013-10-01; Completion date: 2014-08-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to investigate the safety and tolerability of oral dose of selumetinib in combination with chemotherapies (cisplatin and gemcitabine) in Japanese patients with advanced biliary tract cancer (BTC). In addition, the pharmacokinetic (PK) profile of selumetinib and chemotherapies will be investigated. Also, the Maximum tolerated dose (MTD) of selumetinib in combination with chemotherapies for Japanese BTC patients will be identified, if possible.

Detailed description:

Arms: arm 1: 25mg/day, 50mg/day and 75mg/day
Interventions: intervention 1: Cisplatin intervention 2: Gemcitabine intervention 3: Selumetinib
Intervention descriptions: intervention 1: day1 and day8 at each cycle intervention 2: day1 and day8 at each cycle intervention 3: 25mg/day, 50mg/day and 75mg/day

Protocol documents:
Clinical trial NCT01955720
Conditions: Hemorrhage
Sponsor: Boehringer Ingelheim
Start date: 2013-09-01; Completion date: 2014-08-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To investigate safety, tolerability, PK and PD of BI 655075 and to establish the BI 655075 dose(s) effective to reverse prolongation of blood coagulation time by dabigatran

Detailed description:

Arms: arm 1: Sequential Crossover to Placebo or BI 655075 arm 2: Sequential Crossover to Placebo or BI 655075 arm 3: Sequential Crossover to Placebo or BI 655075 arm 4: Sequential Crossover to Placebo or BI 655075
Interventions: intervention 1: BI 655075 intervention 2: BI 655075 intervention 3: Placebo intervention 4: BI 655075 intervention 5: Placebo intervention 6: Placebo intervention 7: Placebo intervention 8: BI 655075
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None

Protocol documents:
Clinical trial NCT01975675
Conditions: Chronic HCV Infection
Sponsor: Gilead Sciences
Start date: 2013-10-01; Completion date: 2014-08-01
Enrollment: 341 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) tablet with or without ribavirin (RBV) in treatment-naive or treatment-experienced Japanese participants with chronic genotype 1 HCV infection. Participants receive 12 weeks of treatment and continue assessments during a 24-week posttreatment follow-up period.

Detailed description:

Arms: arm 1: Treatment-naive participants will receive LDV/SOF for 12 weeks. arm 2: Treatment-naive participants will receive LDV/SOF plus RBV for 12 weeks. arm 3: Treatment-experienced participants will receive LDV/SOF for 12 weeks. arm 4: Treatment-experienced participants will receive LDV/SOF plus RBV for 12 weeks.
Interventions: intervention 1: LDV/SOF intervention 2: RBV
Intervention descriptions: intervention 1: LDV/SOF 90/400 mg FDC tablet administered orally once daily intervention 2: RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, \> 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)

Protocol documents:
Clinical trial NCT01984892
Conditions: Melanoma Squamous Cell Carcinoma of the Head and Neck Squamous Cell Carcinoma of the Skin Sarcoma of the Skin Basal Cell Cancer of the Skin Breast Cancer
Keywords: Autologous Vaccination Intratumoral Injections Intramuscular Injections Advanced Accessible Solid Tumors Poly-ICLC Phase II Clinical Trial Safety Efficacy Autovaccination In Situ Host Targeted Strategy Overall Survival Immunotherapy Adjuvant
Sponsor: Nina Bhardwaj
Start date: 2013-11-01; Completion date: 2014-08-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test the safety of a course of injections containing Poly-ICLC in patients with advanced solid tumors that can be easily and safely reached with a needle.

Poly-ICLC is a compound that has been used to help the body in its fight against cancer.

Detailed description:
We hypothesize that this therapeutic in-situ autovaccination strategy is comprised of three immunomodulatory steps. The first is the innate immune local tumor killing induced by intratumoral Hiltonol (via NK, TNF, etc). A very close second step is optimal Th1-weighted priming through the in-situ combination of the poly-ICLC danger signal with the tumor antigens released in step 1 and further processed and cross-presented by poly-ICLC activated mDC, etc. The repeated administration of the Hiltonol danger signal IT in the context of the patient's own tumor antigens and in a way that mimics a natural viral infection may be critical to this step. Once the system is optimally primed, the third step is targeting and maintenance of the immune response and its facilitation at remote tumor sites with IM poly-ICLC through chemokine release, inflammasome activation and other costimulatory factors.

Arms: arm 1: Enrolled patients will receive two cycles of Poly-ICLC treatment. Each priming (intratumoral injections - IT) and boosting (intramuscular injections - IM) treatment course will constitute one cycle.
Interventions: intervention 1: Poly-ICLC
Intervention descriptions: intervention 1: Cycle 1-Weeks 1 and 2: 1mg Poly-ICLC intratumoral (IT) injections (t=6) into same lesion over 2 weeks.

Weeks 3-9: 1mg Poly-ICLC 2x/week intramuscularly (IM) into thighs or upper arms.

Week 10: No treatment. CT scan of chest, abdomen, pelvis and extremities or neck; possible MRI brain scan.

Cycle 2-Weeks 11 and 12: 1mg Poly-ICLC IT injections (t=6) into same lesion over 2 weeks.

Weeks 13-19 - 1mg Poly-ICLC 2x/weekly IM in thighs or upper arms.

Weeks 20-26: no treatment. Week 26, evaluate response in absence of inflammation.

Maintenance - Weeks 27-36: For patients with stable disease or response; IM poly-ICLC injections; evaluation of clinical and immune response. Week 38 repeat tumor assessment, optional biopsy

Follow Up via phone every 3 months for 30months, after completion of treatments.

Protocol documents:
Clinical trial NCT02002702
Conditions: Acute Heart Failure
Keywords: Acute heart failure (AHF), Japanese, Safety and tolerability, Pharmacokinetics, Renal Impairment
Sponsor: Novartis Pharmaceuticals
Start date: 2014-01-01; Completion date: 2014-08-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, double-blind, placebo-controlled study to assess safety, tolerability and pharmacokinetics and to explore efficacy of IV infusion of 10 µg/kg/day and 30 µg/kg/day serelaxin for 48 hours compared to placebo, when added to the standard therapy, in approximately 45 Japanese AHF patients.

Detailed description:

Arms: arm 1: Participants received 10 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours. arm 2: Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours. arm 3: Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
Interventions: intervention 1: Serelaxin intervention 2: Placebo
Intervention descriptions: intervention 1: Intravenous infusion intervention 2: Placebo

Protocol documents:
Clinical trial NCT02028780
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-01-01; Completion date: 2014-08-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI 655075 following intravenous administration of single rising doses of BI 655075 when administered alone and after administration of dabigatran.

Detailed description:

Arms: arm 1: different infusion durations arm 2: short infusion with 2 capsules dabigatran
Interventions: intervention 1: Placebo to dose intervention 2: Idarucizumab intervention 3: Placebo to Idarucizumab intervention 4: dabigatran intervention 5: Idarucizumab
Intervention descriptions: intervention 1: placebo intervention 2: short infusion intervention 3: Placebo to Idarucizumab intervention 4: 2 capsules dabigatran intervention 5: short infusion

Protocol documents:
Clinical trial NCT02040090
Conditions: Rabies
Sponsor: Kamada, Ltd.
Start date: 2013-04-01; Completion date: 2014-08-01
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to: 1. Evaluate the safety and tolerability of KamRAB in comparison with Human rabies immune globulin (HRIG) comparator product. 2. To assess whether KamRAB interferes with the development of self active antibodies when given simultaneously with active rabies vaccine, as compared to the HRIG comparator product, also given in conjunction with the active rabies vaccine.

Detailed description:
This is a prospective, randomized, double-blind, and single period non-inferiority and safety study conducted at a single study site. Subjects were randomized into the following two groups:

Group A: KamRAB (20 IU/kg by weight \[bw\]) intramuscular (IM), rabies vaccine (1.0 mL; ≥2.5 IU/mL) IM Group B: Human rabies immune globulin (HRIG) Comparator product (20 IU/kg bw) IM, rabies vaccine (1.0 mL; ≥2.5 IU/mL) IM The primary endpoint was a dichotomous (0-1) variable, defined by reaching an anti-rabies immunoglobulin G (IgG) concentration ≥0.5 IU/mL on Day 14. The primary hypothesis was that the proportion of KamRAB + vaccine recipients with anti-rabies concentration ≥0.5 IU/mL on Day 14 would not be less than the corresponding proportion of HRIG Comparator subjects by as much as 0.1.

The safety and tolerability of the study treatments was assessed based on: vital signs and physical examination findings, electrocardiogram (ECG), laboratory findings (hematology, clinical chemistry, and urinalysis) and the occurrence of adverse events (AEs) after drug administration

Arms: arm 1: KamRAB 20 IU/kg body weight via IM injection, once on Day 0 arm 2: Comparator product: Intramuscular (IM) injection once on Day 0 in the same manner and at the same dosage as KamRAB.
Interventions: intervention 1: Active rabies vaccine (US-FDA approved)
Intervention descriptions: intervention 1: A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28 On day 0, the day when the HRIG is given, the first vaccine dose could be given within few minutes from the time of HRIG injection was given and never be administered into the same anatomical site as the HRIG.

Protocol documents:
Clinical trial NCT02040792
Conditions: COPD
Keywords: COPD Chronic Obstructive Pulmonary Disease
Sponsor: Mylan Inc.
Start date: 2014-05-01; Completion date: 2014-08-01
Enrollment: 355 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the safety and efficacy of four doses of TD-4208 and a placebo product when administered once daily for 28 days using a jet nebulizer to patients with moderate to severe chronic obstructive pulmonary disease.

Detailed description:

Arms: arm 1: Placebo arm 2: TD-4208 arm 3: TD-4208 arm 4: TD-4208 arm 5: TD-4208
Interventions: intervention 1: TD-4208 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02051790
Conditions: Alzheimer's Disease
Sponsor: Avid Radiopharmaceuticals
Start date: 2014-03-01; Completion date: 2014-08-01
Enrollment: 241 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to evaluate the agreement between florbetapir F 18 scan interpretation in the clinic and by expert readers.

Detailed description:

Arms: arm 1: Approximately 250 florbetapir F 18 scans and final scan reports interpreted in a clinical setting will be collected from physicians across the country. These results will then be compared to expert panel interpretations for the same scans.
Interventions: intervention 1: florbetapir F 18
Intervention descriptions: intervention 1: No study drug will be administered in this study - scans previously acquired in the course of clinical practice.

Protocol documents:
Clinical trial NCT02053753
Conditions: Healthy Volunteer
Keywords: denosumab, bioequivalence
Sponsor: Amgen
Start date: 2014-02-01; Completion date: 2014-08-01
Enrollment: 146 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the bioequivalence based on pharmacokinetics (PK) of a single 120 mg subcutaneous dose of denosumab administered to healthy volunteers using denosumab CP4 or denosumab CP2 drug products.

Detailed description:

Arms: arm 1: Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1. arm 2: Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.
Interventions: intervention 1: Denosumab CP4 intervention 2: Denosumab CP2
Intervention descriptions: intervention 1: Denosumab produced by a process referred to as CP4, administered subcutaneously. intervention 2: Denosumab produced by a process referred to as CP2, administered subcutaneously.

Protocol documents: