ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01936974
Conditions: Ovarian Carcinoma Fallopian Tube Carcinoma Peritoneal Carcinoma
Sponsor: Western Regional Medical Center
Start date: 2013-09-01; Completion date: 2015-08-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate progression-free survival with two chemotherapy regimens on platinum-resistant/refractory ovarian and peritoneal carcinoma

Detailed description:
This study will evaluate progression-free survival (PFS)for the regimen of gemcitabine and bevacizumab with or without a platinum agent on platinum-resistant/refractory ovarian and peritoneal carcinoma

Arms: arm 1: Platinum:

1. Carboplatin\* on day 1

   \*If a patient is allergic to carboplatin, then give
2. Cisplatin\*\* on day 1

   \*\*If a patient is allergic to cisplatin and carboplatin, then give
3. Oxaliplatin on day 1

Gemcitabine on day 1 only

Bevacizumab on day 1 arm 2: Gemcitabine on days 1 and 8

Bevacizumab on day 1
Interventions: intervention 1: Gemcitabine intervention 2: Bevacizumab intervention 3: Carboplatin intervention 4: Cisplatin intervention 5: Oxaliplatin
Intervention descriptions: intervention 1: Patient to receive gemzar intervention 2: Patient to receive avastin intervention 3: Patient to receive carboplatin intervention 4: Patient to receive cisplatin intervention 5: Patient to receive Oxaliplatin

Protocol documents:
Clinical trial NCT01937715
Conditions: Metastatic Colorectal Carcinoma
Sponsor: Pfizer
Start date: 2014-02-01; Completion date: 2015-08-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter, open label Phase 1b/2 study in patients with metastatic colorectal carcinoma. The Phase 1b will identify the dose of the combination of PF-05212384 plus FOLFIRI. The randomized, two-arm Phase 2 portion will compare the efficacy and safety of PF-05212384 plus FOLFIRI to that of bevacizumab plus FOLFIRI.

The study population will consist of patients with mCRC previously treated with an oxaliplatin-based regimen in the first line setting or who have progressed within 6 months of the end of an adjuvant oxaliplatin-based regimen.

Detailed description:

Arms: arm 1: PF-05212384 plus FOLFIRI arm 2: Bevacizumab plus FOLFIRI
Interventions: intervention 1: PF-05212384 intervention 2: FOLFIRI regimen intervention 3: Bevacizumab intervention 4: FOLFIRI
Intervention descriptions: intervention 1: PF-05212384 at the Recommended phase 2 dose (RP2D/MTD) weekly intervention 2: The RP2D/MTD dose of FOLFIRI regimen every 2 weeks intervention 3: 5 mg/m\^2 every 2 weeks or 7.5 mg/m\^2 every 3 weeks intervention 4: Full dose FOLFIRI regimen every 2 weeks

Protocol documents:
Clinical trial NCT01943552
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2013-10-01; Completion date: 2015-08-01
Enrollment: 192 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled, parallel-group, multi-centre trial.The trial aims to evaluate efficacy of nebulized ipratropium bromide in Chinese peri-operative patients with COPD under general anaesthesia.

Detailed description:

Arms: arm 1: 500 mcg four times a day arm 2: None
Interventions: intervention 1: placebo intervention 2: ipratropium bromide
Intervention descriptions: intervention 1: normal saline intervention 2: ipratropium bromide

Protocol documents:
Clinical trial NCT01950741
Conditions: Exudative Age-related Macular Degeneration Polypoidal Choroidal Vasculopathy
Sponsor: Pusan National University Hospital
Start date: 2013-09-01; Completion date: 2015-08-01
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Effects of VEGF Trap-Eye (aflibercept) in treatment-naive polypoidal choroidal vasculopathy (PCV) will be evaluated.

Detailed description:
Efficacy of VEGF Trap-Eye (aflibercept, Eylea) for exudative age-related macular degeneration (AMD) was demonstrated in the phase III VIEW study. Polypoidal choroidal vasculopathy (PCV) is considered as a subtype of exudative AMD, however it is reportedly different from choroidal new vessels based on the histologic studies. The aim of this study is to evaluate effects of VEGF Trap-Eye in treatment of PCV, which was diagnosed using indocyanine green (ICG) angiography. VEGF Trap-Eye will be injected intravitreally bimonthly after 3 monthly loading dose for 12 months in treatment-naive PCV patients. The efficacy will be evaluated on preserving visual acuity and improving angiographic features at 12 months.

Arms: arm 1: Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).
Interventions: intervention 1: aflibercept
Intervention descriptions: intervention 1: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe.

Protocol documents:
Clinical trial NCT01951170
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2013-11-01; Completion date: 2015-08-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single-arm study will evaluate the efficacy and safety of tocilizumab in patients with active moderate to severe rheumatoid arthritis. Participants will receive a subcutaneous dose of tocilizumab 162 mg once weekly. The anticipated time on study treatment is 24 weeks.

Detailed description:

Arms: arm 1: Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Interventions: intervention 1: Tocilizumab
Intervention descriptions: intervention 1: 162 milligrams (mg) tocilizumab was administered subcutaneously once weekly for 24 weeks

Protocol documents:
Clinical trial NCT01962922
Conditions: Renal Failure
Sponsor: Veloxis Pharmaceuticals
Start date: 2013-11-01; Completion date: 2015-08-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Open label, prospective, single-center, randomized, two sequence, three period crossover study to compare the steady state pharmacokinetics of LCP-Tacro tables to generic tacrolimus capsules administered twice daily in stable African-American renal transplant patients.

Detailed description:
This is open label, prospective, single-center, randomized, two sequence, three period crossover study to compare the steady state pharmacokinetics of once daily dosing of LCP-Tacro tablets to tacrolimus capsules administered twice daily in stable African American kidney transplant patients.

Approximately 72 male and female African American renal transplant patients on table immunosuppression regimens will be randomly assigned in a 1:1 ratio to one of two sequences:

Sequence 1: (n=36) 18 patients requiring less than 0.15 mg/kg/day and 18 patients requiring equal to or greater than 0.15 mg/kg/day. Patients will continue on generic tacrolimus capsules on days 1-7 (24 hours PK profile on day 7) then patients are switched to LCP-Tacro tablets (at 15% lower dose of twice daily generic tacrolimus) on day 8.

Sequence 2: (n=36) 18 patients requiring less than 0.15 mg/kg/day and 18 patients requiring equal to or greater than 0.15 mg/kg/day. Patients will receive LCP-Tacro tablets (at 15% lower dose than generic tacrolimus twice daily formulation) on days 1-7 (24 hour PK profile on day 7) patients are switched back to twice daily generic tacrolimus treatment beginning on day 8.

Arms: arm 1: Envarsus XR arm 2: Tacrolimus
Interventions: intervention 1: LCP-Tacro intervention 2: Tacrolimus -IR
Intervention descriptions: intervention 1: once-daily extended release tablet intervention 2: twice daily capsules

Protocol documents:
Clinical trial NCT01980095
Conditions: Dyspepsia Helicobacter Pylori Infection
Keywords: Helicobacter pylori H. pylori Dyspepsia
Sponsor: RedHill Biopharma Limited
Start date: 2013-11-01; Completion date: 2015-08-01
Enrollment: 119 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The "test and treat" strategy for treating dyspeptic patients who are H. pylori positive is rapidly becoming the standard of care. This study will test the effectiveness of RHB-105, a new triple therapy to treat H. pylori infection in dyspeptic patients.

Detailed description:
This is a, randomized, double-blind, placebo-controlled study of RHB-105 in adult subjects complaining of epigastric discomfort that have been screened and found to be positive for H. pylori infection via 13C Urea Breath Test (UBT) and either fecal antigen test or CLO test.

Eligible subjects will be randomized in a ratio of 1:2 between placebo arm (n=30) and the active arm (RHB-105) (n=60). Subjects will receive study drug for 14 consecutive days. Eradication of H. pylori infection will be determined based on 13C UBT conducted between 28 to 56 days after completion of study drug therapy.

Subjects will be unblinded upon 13C UBT analysis. This will provide timely active therapy to all subjects enrolled in this study. Subjects in the placebo arm will be entitled to receive standard-of-care as prescribed by the treating physician following un-blinding.

Eradication failures (13C UBT-positive) in the active study drug arm will undergo upper endoscopy with sampling for culture and sensitivity testing (to rifabutin, amoxicillin, clarithromycin, and metronidazole). Culture and sensitivity directed therapy as prescribed by the treating physician will be offered to these subjects.

Arms: arm 1: RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule. arm 2: Capsules that look like the RHB-105 product but contain no active ingredient.
Interventions: intervention 1: RHB-105 intervention 2: Placebo
Intervention descriptions: intervention 1: The intended dose is RHB-105 (12.5 mg rifabutin, 250 mg amoxicillin, and 10 mg omeprazole capsules) 4 capsules every eight hours, equivalent to a total daily dose of:

* Rifabutin 150 mg
* Amoxicillin 3000 mg
* Omeprazole 120 mg

Subjects will take study drug every 8 hours with food for 14 consecutive days. intervention 2: Subjects will take 4 placebo capsules every 8 hours with food for 14 days.

Protocol documents:
Clinical trial NCT01994291
Conditions: Macular Edema, Diabetic
Keywords: Chemokine Antagonist Diabetic Macular Edema Diabetes Diabetes Mellitus Macular Edema Diabetic Retinopathy Anti-VEGF
Sponsor: Pfizer
Start date: 2013-11-01; Completion date: 2015-08-01
Enrollment: 199 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study hypothesis under test is that administration of the CCR2/5 antagonist has the potential to be as effective as the current treatment options for subjects with diabetic macular edema. The current treatment option for these subjects is an injection directly into the eye, while this CCR2/5 antagonist would be an oral drug which has the potential to be just as effective. This CCR2/5 antagonist also has a broader anti-inflammatory potential and might be able to provide an alternative mechanism to treat Diabetic Macular Edema.

Detailed description:
Study recruitment was stopped on April 9, 2015. This decision was taken for business reasons due to changes in the prioritization of the drug development portfolio. This decision was not as a result of any evolving safety, efficacy issue or changes in the risk:benefit assessment of this product or regulatory interactions.

Arms: arm 1: Intravitreal administration of ranibizumab (either 0.3 or 0.5 mg, given monthly, as detailed in the prescribing information and label content approved for the country governing the study site) plus an oral placebo. arm 2: Oral PF-04634817 200 mg, once daily plus a masked sham therapy (given monthly).
Interventions: intervention 1: Ranibizumab intervention 2: Placebo intervention 3: PF-04634817 intervention 4: Masked Sham Therapy
Intervention descriptions: intervention 1: Intravitreal Injection supplied as:

* 10 mg/mL in a 0.2 mL vial with instructions on preparation and administration of the 0.5 mg (0.05 mL) dose.
* 6 mg/mL in a single use vial with instructions on preparation and administration of the 0.3 mg (0.05 mL) dose.
* Adminstered once a month for 12 weeks intervention 2: Oral Placebo is provided in tablet form to match the 50mg dose of PF-04634817.

Dose is 4 tablets each day for 12 weeks intervention 3: Four 50mg tablets PF-04634817 once a day for 12 weeks. intervention 4: Empty, needle-less syringe is used by the unmasked team once a month.

Protocol documents:
Clinical trial NCT01999777
Conditions: Epilepsy
Keywords: Epilepsy seizure clusters acute repetitive seizures rescue treatment
Sponsor: UCB Biopharma S.P.R.L.
Start date: 2013-11-01; Completion date: 2015-08-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the efficacy, safety, and tolerability of USL261 compared with that of intranasal (IN) placebo for the treatment of intermittent bouts of increased seizure activity.

Detailed description:

Arms: arm 1: 5 mg intranasal midazolam arm 2: intranasal placebo
Interventions: intervention 1: USL261 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02005601
Conditions: Total Knee Arthroplasty
Sponsor: Hospital for Special Surgery, New York
Start date: 2013-11-01; Completion date: 2015-08-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We are investigating the impact of duloxetine ("Cymbalta"), a serotonin and norepinephrine reuptake inhibitor, on pain after total knee arthroplasty (TKA). Specifically, the investigators will determine whether duloxetine, 60 mg daily for 2 weeks, reduces pain scores 2 weeks after TKA.

Detailed description:

Arms: arm 1: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14. arm 2: Patients will receive 0mg of duloxetine
Interventions: intervention 1: Placebo intervention 2: Duloxetine 60mg
Intervention descriptions: intervention 1: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14. intervention 2: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.

Protocol documents:
Clinical trial NCT02014467
Conditions: Osteoporosis, Postmenopausal
Sponsor: GlaxoSmithKline
Start date: 2014-01-01; Completion date: 2015-08-01
Enrollment: 486 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate the efficacy and safety of denosumab 60 milligrams (mg) for 12 month treatment in Chinese postmenopausal women with osteoporosis at increased risk of fracture.

Detailed description:
The aim of this Phase III, randomized, double-blind, placebo-controlled, parallel-group study is to evaluate the efficacy and safety of denosumab (DMAb) in Chinese postmenopausal women with osteoporosis at increased risk of fracture. The study design consists of two phases: Screening and 12-month Double-Blind treatment phase. Following the Screening phase, all eligible subjects will be randomized to receive Double-Blind DMAb (60 mg) or Placebo study medication in a 3:1 ratio. DMAb 60 mg and placebo will be administered as a single subcutaneous (SC) injection at the beginning of the Double-Blind phase and at 6 months following the initial dose. All subjects will receive daily supplementation of oral elemental calcium (at least 600 mg) and vitamin D (at least 400 International Units \[IU\]). The primary objective is to determine the effects of DMAb compared to placebo with respect to mean percent change in BMD at the lumbar spine, as measured by dual-energy x-ray absorptiometry (DXA), from Baseline to Month 12. Secondary objectives include the evaluation between the DMAb and placebo treatment groups: change in BMD: at the lumbar spine (Month 6), total hip (Months 6 and 12), femoral neck (Months 6 and 12) and trochanter (Months 6 and 12); and serum biomarkers of bone formation and resorption (Months 6 and 12). Clinical safety of denosumab will also be assessed in this population.

Arms: arm 1: injection arm 2: injection
Interventions: intervention 1: Denosumab intervention 2: Placebo intervention 3: Elemental Calcium intervention 4: Vitamin D
Intervention descriptions: intervention 1: Injection intervention 2: Injection intervention 3: Oral, at least 600 mg intervention 4: Oral, at least 400 IU

Protocol documents:
Clinical trial NCT02015234
Conditions: Primary Fibromyalgia
Keywords: TNX-102 SL bedtime sublingual 12-month long term safety long term efficacy Fibromyalgia
Sponsor: Tonix Pharmaceuticals, Inc.
Start date: 2013-12-01; Completion date: 2015-08-01
Enrollment: 158 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was an open-label, extension trial designed to evaluate the long-term safety over 12 months of TNX-102 SL tablets taken daily at bedtime for the treatment of fibromyalgia. Patients recruited into this trial were those who had successfully completed the double-blind study, TNX-CY-F202 (F202) (NCT01903265). Patients were not made aware of the therapy they received during the double-blind study.

Detailed description:
The study consisted of 7 clinic visits, including Screening/Baseline Visit 1 (Day 0 which was typically the same date as Visit 6 of the double-blind lead-in study), visits after 1, 3, 6, 9, and 12 months of treatment (Visits 2-6), and a Follow-up Visit (Visit 7) scheduled within one month after stopping study drug treatment.

Primary:

The primary objective of the study was to evaluate the long-term safety of TNX-102 SL tablets taken daily at bedtime over 12 months in patients with fibromyalgia who have completed Study TNX-CY-F202 (NCT01903265)

Secondary:

The secondary objective was to evaluate the long-term efficacy of TNX-102 SL tablets taken daily at bedtime to control symptoms of fibromyalgia

Arms: arm 1: 1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 12 months
Interventions: intervention 1: TNX-102 SL
Intervention descriptions: intervention 1: TNX-102 SL 2.8 mg taken daily at bedtime.

Protocol documents:
Clinical trial NCT02038023
Conditions: Pregnancy
Keywords: Iv iron in pregnant women second and third trimester
Sponsor: Auerbach Hematology Oncology Associates P C
Start date: 2013-07-01; Completion date: 2015-08-01
Enrollment: 74 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed).

Detailed description:
To determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed).

To determine whether IV iron supplementation has a higher satisfaction with treatment as compared to oral supplementation in a population previously intolerant of or unresponsive to oral iron.

To evaluate the safety of IV low molecular weight iron dextran in pregnant women.

To assess maternal and fetal outcomes-preterm delivery, low birth weight deliveries, ER visits and hospitalizations related to preterm labor, preterm contractions, ante-partum and post-partum transfusions, maternal hemoglobin at post-partum visit after IV iron supplementation groups.

Arms: arm 1: Intravaneous iron(1000 mg low molecular weight iron dextran over 60 minutes) for moderate to severe iron deficient anemia of pregnancy in women intolerant of or unresponsive to oral iron.
Interventions: intervention 1: Intravaneous iron(low molecular weight iron dextran)
Intervention descriptions: intervention 1: 1000 mg of Iron dextran administered over one hour

Protocol documents:
Clinical trial NCT02040532
Conditions: Menopause Hot Flashes Vasomotor Disturbance
Sponsor: Massachusetts General Hospital
Start date: 2014-01-01; Completion date: 2015-08-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The broad goal of this study is to obtain pilot data to determine the tolerability and preliminary efficacy of the non-hormonal agent gabapentin for insomnia symptoms and nighttime vasomotor Symptoms (VMS) when open-label gabapentin is administered at low dose and only at night in peri- and postmenopausal women. We hypothesize that the majority of participants will be able to increase and tolerate treatment, and insomnia symptoms and the frequency of nighttime VMS will improve on low-dose gabapentin dosed at bedtime.

Detailed description:
Thirty-two peri- and postmenopausal women at the Boston sites (MGH and BWH) were enrolled into this open-label pilot study. The study was a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks. The intervention study followed a 3-week screening period to establish a stable baseline for insomnia symptoms and VMS and to determine the safety of administering gabapentin in study participants. Tolerability and treatment response (insomnia symptoms, nighttime VMS) were assessed systematically at each study visit. The dose titration schedule was followed in all participants unless there are dose-limiting toxicities.

Arms: arm 1: Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.
Interventions: intervention 1: Gabapentin
Intervention descriptions: intervention 1: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks.

Protocol documents: