ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02138825
Conditions: Idiopathic Interstitial Pneumonias / Hypertension,Pulmonary
Sponsor: Bayer
Start date: 2014-06-04; Completion date: 2016-09-14
Enrollment: 147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of 26-weeks of treatment with riociguat vs. placebo in patients with symptomatic PH (pulmonary hypertension) associated with IIP (idiopathic interstitial pneumonias).

Detailed description:
Number of participants with Adverse Events (AEs) will be reported in Adverse Events section.

Arms: arm 1: In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team. arm 2: In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team.
Interventions: intervention 1: Riociguat (Adempas, BAY63-2521) intervention 2: Placebo
Intervention descriptions: intervention 1: Active drug 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID/day as per individual dose titration. The starting dose will be 0.5 mg TID, and the dose will be adjusted every two weeks for ten weeks in 0.5 mg increments up to a maximum dose of 2.5 mg TID based on patient's systolic blood pressure and well-being. intervention 2: Inactive dosed at 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID/day as per individual dose titration for 26 weeks

Protocol documents:
Clinical trial NCT02275481
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic obstructive pulmonary disease COPD Emphysema Chronic bronchitis
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2014-11-01; Completion date: 2016-09-14
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, open-label, parallel group, multicenter, outpatient study in COPD subjects who are discharged from the hospital due to a COPD exacerbation. Subjects who meet the eligibility criteria will be randomized to 1 of 2 treatments: arformoterol tartrate inhalation solution (BROVANA) 15 mcg twice daily (BID) or tiotropium bromide (SPIRIVA) 18 mcg once daily (QD), each given for 90 days.

Detailed description:
This is a randomized, open-label, parallel group, multicenter, outpatient study in COPD subjects who are discharged from the hospital following a COPD exacerbation. Subjects who meet the eligibility criteria will be randomized to 1 of 2 treatments. Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor. Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.

Study medications will be dispensed to the subject at Visit 1. The objective of the study is to determine the comparative effectiveness of arformoterol and tiotropium on re-hospitalization and to assess safety in Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an acute exacerbation.

Arms: arm 1: Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor arm 2: Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
Interventions: intervention 1: Arformoterol tartrate inhalation solution intervention 2: Tiotropium
Intervention descriptions: intervention 1: Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor intervention 2: Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.

Protocol documents:
Clinical trial NCT01015118
Conditions: Ovarian Neoplasms Peritoneal Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2009-11-17; Completion date: 2016-09-15
Enrollment: 1366 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in first-line treatment of patients with advanced ovarian cancer. Safety information about BIBF1120/paclitaxel/carboplatin will be obtained.

Detailed description:

Arms: arm 1: patients to receive BIBF 1120 standard dose twice daily PO in combination with combination with carboplatin and paclitaxel arm 2: patients to receive capsules identical to those containing BIBF 1120 in combination with combination with carboplatin and paclitaxel
Interventions: intervention 1: Placebo intervention 2: Paclitaxel intervention 3: BIBF 1120 intervention 4: Carboplatin intervention 5: Paclitaxel intervention 6: Carboplatin
Intervention descriptions: intervention 1: comparator to BIBF 1120 intervention 2: Paclitaxel (standard chemo-therapy) intervention 3: comparison of BIBF 1120 in combination with chemotherapy and placebo in combination with chemotherapy (paclitaxel/carboplatin) intervention 4: Carboplatin (standard chemo-therapy) intervention 5: Paclitaxel (standard chemo-therapy) intervention 6: Carboplatin (standard chemo-therapy)

Protocol documents:
Clinical trial NCT01918761
Conditions: Non Small Cell Lung Cancer
Keywords: NSCLC Stage IV Pemetrexed Dacomitinib
Sponsor: Central European Cooperative Oncology Group
Start date: 2013-07-30; Completion date: 2016-09-15
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To identify a dose of dacomitinib in combination with pemetrexed that is safe and tolerated as determined by the incidence of DLTs (dose limiting toxicities).

Detailed description:
This open label phase Ib trial aims to determine the safety, tolerability, the pharmacokinetic profile, and to identify a dose of dacomitinib in combination with pemetrexed.

Three sites in Austria will participate in this study. Six to nine patients will initially be enrolled to receive the target dose of 45 mg qd dacomitinib (starting from day 2 of first cycle) in combination with pemetrexed (500 mg/m² 10 min infusion, once every 3 weeks). One cycle is defined as 21 days.

The first 3 subjects will be enrolled at a rate of ≤ 1 subject per week. If the target dose regimen is safe based on the incidence of DLT another 3 subjects will be enrolled.

If the dose of 45 mg qd is not safe alternate lower doses will be explored (dose level -1, dose level -2) to identify the maximal tolerated dose (MTD) of dacomitinib in combination of pemetrexed. Six to nine patients per dose level will be enrolled.

Arms: arm 1: Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)
Interventions: intervention 1: Dacomitinib, Pemetrexed
Intervention descriptions: intervention 1: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)

Protocol documents:
Clinical trial NCT01970371
Conditions: Bloodstream Infections (BSI) Due to CRE Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE Ventilator-Associated Bacterial Pneumonia (VABP) Due to CRE Complicated Urinary Tract Infection (cUTI) Due to CRE Acute Pyelonephritis (AP) Due to CRE
Keywords: Gram-negative bacterial infection antibacterial antimicrobial CRE CPE BSI pneumonia HABP VABP AP cUTI UTI
Sponsor: Achaogen, Inc.
Start date: 2014-09-16; Completion date: 2016-09-15
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a Phase 3 study containing a randomized open-label superiority cohort (Cohort 1) comparing the efficacy and safety of plazomicin with colistin when combined with a second antibiotic (either meropenem or tigecycline) in the treatment of patients with bloodstream infection (BSI), hospital acquired bacterial pneumonia (HABP), or ventilator-associated bacterial pneumonia (VABP) due to CRE. An additional cohort of patients with BSI, HABP, VABP, complicated urinary tract infection (cUTI), or acute pyelonephritis (AP) due to CRE, not eligible for inclusion in the other cohort, were enrolled into a single arm (Cohort 2) and treated with plazomicin-based therapy. Therapeutic drug management (TDM) was used to help ensure that plazomicin exposures lie within an acceptable range of the target mean steady-state area under the curve (AUC).

Detailed description:

Arms: arm 1: Cohort 1: Patients received 15 milligram per killogram (mg/kg) plazomicin therapy (plus meropenem or tigecycline) as a 30-minute intravenous (IV) infusion once daily for 7 to 14 days. arm 2: Cohort 1: Patients received a 5 mg/kg IV loading dose (300 mg maximum) colistin (plus meropenem or tigecycline) followed by a 5 mg/kg/d maintenance dose divided into every 8 hours (q8h) or every 12 hours (q12h) for 7 to 14 days. arm 3: Cohort 2: Patients received 15 mg/kg as a 30 minute IV infusion once daily. BSI, HABP or VABP patients received plazomicin and any supplemental antibiotic therapy, according to Investigator's choice, for 7 to 14 days. cUTI or AP patients received plazomicin monotherapy only for 4 to 7 days with an option to switch to oral therapy on or after Day 5.
Interventions: intervention 1: plazomicin intervention 2: colistin intervention 3: meropenem intervention 4: tigecycline intervention 5: antibiotic of Investigator's choice
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT02300103
Conditions: Hepatitis C Virus Infection
Sponsor: Gilead Sciences
Start date: 2014-12-01; Completion date: 2016-09-15
Enrollment: 69 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead sponsored study and did not achieve sustained virologic response (SVR).

Detailed description:

Arms: arm 1: Participants will receive SOF/VEL fixed dose combination (FDC) and RBV for 24 weeks.
Interventions: intervention 1: SOF/VEL intervention 2: RBV
Intervention descriptions: intervention 1: 400/100 mg FDC tablet administered orally once daily intervention 2: Tablet (s) 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 NCT02337725
Conditions: Parkinson's Disease
Sponsor: Takeda
Start date: 2015-02-07; Completion date: 2016-09-15
Enrollment: 244 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of TVP-1012 (1 mg/day) administered to Japanese patients with early Parkinson's disease.

Detailed description:
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 study to evaluate the efficacy and safety of TVP-1012 in Japanese participants with early Parkinson's disease.

The study period consisted of a 28-week trial period. The participants who fulfill the inclusion criteria and not meeting any of the exclusion criteria were enrolled, and randomized in a 1:1 ratio to either the 1 mg of TVP-1012 or the placebo group. In each treatment group, participants received either 1 mg of TVP-1012 or placebo once daily in a double-blinded manner.

Arms: arm 1: For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast. arm 2: For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.
Interventions: intervention 1: TVP-1012 intervention 2: Placebo
Intervention descriptions: intervention 1: TVP-1012 1mg Tablets intervention 2: Placebo tablets

Protocol documents:
Clinical trial NCT02474069
Conditions: Moderate to Severe Plaque-type Psoriasis
Keywords: skin condition skin disease itching condition psoriasis vulgaris relapsing psoriasis remitting psoriasis immune-mediated systemic disease skin lesions, red skin lesions scaly patches papules, plaques itching auto-immune plaque-type psoriasis plaque
Sponsor: Novartis Pharmaceuticals
Start date: 2015-02-08; Completion date: 2016-09-15
Enrollment: 772 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to support the optimal use of secukinumab by providing data to refine guidance on dosing flexibility in patients with psoriasis. The purpose of the study is to explore the effects of dosage interval shorteng to achieve PASI 90 at week 32 for patients who had less than almost clear skin at week 16.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Secukinumab
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02288325
Conditions: Depressive Disorder, Major
Keywords: Fetzima Relapse-prevention Placebo-controlled
Sponsor: Forest Laboratories
Start date: 2014-11-18; Completion date: 2016-09-16
Enrollment: 644 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the efficacy, safety and tolerability of levomilnacipran extended-release (ER) compared with placebo in the prevention of depression relapse in major depressive disorder (MDD).

Detailed description:

Arms: arm 1: FETZIMA® (levomilnacipran extended release \[ER\]) taken orally during flexible dose titration up to 40, 80 or 120 mg once daily in 8-week run-in period followed by fixed dose of 40, 80 or 120 mg once daily in 12-week stabilization period. arm 2: Dose-matched placebo taken orally once daily for 26 weeks during double-blind treatment period. arm 3: FETZIMA® (levomilnacipran ER) taken orally at fixed dose of 40, 80 or 120 mg once daily for 26 weeks during double-blind treatment period.
Interventions: intervention 1: Levomilnacipran ER intervention 2: Placebo
Intervention descriptions: intervention 1: Levomilnacipran ER taken orally at 40, 80 or 120 mg once daily. intervention 2: Dose-matched placebo taken orally once daily.

Protocol documents:
Clinical trial NCT01120184
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2010-07-31; Completion date: 2016-09-16
Enrollment: 1095 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: docetaxel intervention 2: paclitaxel intervention 3: pertuzumab intervention 4: pertuzumab-placebo intervention 5: trastuzumab [Herceptin] intervention 6: trastuzumab emtansine
Intervention descriptions: intervention 1: 75 mg/m2 or 100 mg/m2 intravenously every 3 weeks for a minimum of 6 cycles. intervention 2: 80 mg/m2 intravenously weekly for a minimum of 18 weeks intervention 3: 840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles intervention 4: 840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles intervention 5: trastuzumab \[Herceptin\] doses when administered with docetaxel: 8 mg/kg intravenously on cycle 1 followed by 6 mg/kg every 3 weeks in subsequent cycles or trastuzumab (Herceptin) doses when administered with paclitaxel: 4 mg/kg intravenously on day 1 of cycle 1 followed by 2 mg/kg weekly starting on day 8 of cycle 1. intervention 6: 3.6 mg/kg intravenously every 3 weeks

Protocol documents:
Clinical trial NCT01227889
Conditions: Cancer
Keywords: Metastatic melanoma melanoma BRAF mutant Advanced melanoma
Sponsor: GlaxoSmithKline
Start date: 2010-12-23; Completion date: 2016-09-16
Enrollment: 251 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
BRF113683 is a Phase III, randomized, open-label study comparing the efficacy, safety, and tolerability of GSK2118436 to dacarbazine (DTIC), in subjects with BRAF mutant advanced (Stage III) or metastatic (Stage IV) melanoma. Subjects will be randomized to receive 150 mg of GSK2118436 twice daily or 1000 mg/m2 DTIC every 3 weeks and continue on treatment until disease progression, death, or unacceptable adverse event. Subjects who progress on DTIC will be allowed to crossover to an optional extension arm of the study to receive GSK2118436.

Detailed description:

Arms: arm 1: Subjects in this arm will receive GSK2118436 150 mg twice daily. arm 2: Subjects will receive intravenous dacarbazine (DTIC) 1000 mg/m2 every 3 weeks arm 3: Subjects who initially receive DTIC will be allowed to receive GSK2118436 after initial progression.
Interventions: intervention 1: GSK2118436 intervention 2: Dacarbazine (DTIC)
Intervention descriptions: intervention 1: 150 mg twice daily intervention 2: Intravenous (IV), 1000 mg/m2 every 3 weeks until initial progression

Protocol documents:
Clinical trial NCT01649856
Conditions: Lymphoma, Large B-Cell, Diffuse
Sponsor: Hoffmann-La Roche
Start date: 2012-08-24; Completion date: 2016-09-16
Enrollment: 572 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 6 months.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CHOP intervention 2: rituximab [MabThera/Rituxan] intervention 3: rituximab [MabThera/Rituxan]
Intervention descriptions: intervention 1: CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles intervention 2: The first rituximab dose will be administered intravenously on Day of Cycle 1 at a dose of 375 mg/m2. Subsequent doses of 1400 mg are administered subcutaneously on Day 1 of each cycle, for a further 7 cycles intervention 3: 375 mg/m2 intravenously on Day 1 of each cycle, 8 cycles

Protocol documents:
Clinical trial NCT02524288
Conditions: Contraception
Sponsor: Organon and Co
Start date: 2015-08-31; Completion date: 2016-09-16
Enrollment: 1941 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the contraceptive efficacy of the Etonogestrel (ENG) + 17β-Estradiol (E2) vaginal ring in women between 18 and 35 years of age based on the number of in-treatment pregnancies as expressed by the Pearl Index (PI). The study will also assess the safety and tolerability of the ENG-E2 vaginal ring.

Detailed description:

Arms: arm 1: Participants will receive up to 13 cycles of ENG-E2 125 μg/300 μg. Each cycle will consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
Interventions: intervention 1: ENG-E2 125 μg/300 μg vaginal ring
Intervention descriptions: intervention 1: Up to 13 cycles of ENG-E2 125 μg/300 μg administered intravaginally, each cycle consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.

Protocol documents:
Clinical trial NCT02669862
Conditions: Common Warts
Sponsor: Aclaris Therapeutics, Inc.
Start date: 2015-12-21; Completion date: 2016-09-16
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups.

Detailed description:
This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups. During Visit 1, the Investigator will identify 1 eligible common wart on the trunk or extremities on each subject. The wart will be treated up to a maximum of 8 times at 1 week intervals during the study.

Arms: arm 1: A-101 Solution 40% administered once per week arm 2: A-101 Solution 45% administered once per week arm 3: Vehicle Solution administered once per week
Interventions: intervention 1: A-101 Solution 40 intervention 2: A-101 Solution 45 intervention 3: Vehicle Solution
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02831660
Conditions: Hemorrhage
Sponsor: Boehringer Ingelheim
Start date: 2016-07-22; Completion date: 2016-09-16
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective is to collect the safety data of idarucizumab for patients treated with dabigatran who require rapid reversal of the anticoagulant effects of dabigatran in cases of uncontrolled or life-threatening bleeding or when emergency surgery or urgent procedures are required.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: idarucizumab
Intervention descriptions: intervention 1: None

Protocol documents: