ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT03110003
Conditions: Spinal Anesthesia Epidural; Anesthesia
Keywords: Neuraxial epidural techniques Combined spinal epidural Epidural volume extension Transient Neurologic Symptoms (TNS)
Sponsor: University of Alabama at Birmingham
Start date: 2016-06-27; Completion date: 2018-09-30
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this study the investigator will address the efficacy of using low dose bupivacaine spinal anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing short obstetric procedures.

Detailed description:
Due to risks to both the mother and fetus, neuraxial anesthesia - spinal, epidural, or combined spinal-epidural (CSE) - is preferred over general anesthesia for all obstetrical procedures. However, one downside to neuraxial anesthesia is the increased time patients have to stay in the post-anesthesia care unit (PACU) due to residual numbness from the neuraxial block. In this study, the investigators will address the efficacy of using low dose bupivacaine spinal anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing short obstetric procedures. This will be accomplished by performing a CSE with: 1) injecting the local anesthesia in the spinal space; 2) injecting sterile saline into the epidural space to help increase the spread of the local anesthesia in the spinal space. The idea is that physicians will be able to use less local anesthetic due to getting a greater spread of medication. This lower amount of local anesthetic will lead to a decreased duration of the spinal block; therefore, it will significantly decrease PACU length of stay. This technique will be compared to our traditional dose of spinal anesthetic without EVE in the CSE. Both groups will have an epidural catheter in place to allow us to give any additional local anesthetic to keep the patient comfortable throughout the procedure if the spinal anesthesia begins to wear off. The aim of this study is to determine if low dose spinal bupivacaine in conjunction with EVE can decrease the PACU recovery time for short obstetric procedures while still providing an adequate surgical block.

Arms: arm 1: Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl. arm 2: Subjects will receive 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.
Interventions: intervention 1: 10 mg Bupivacaine intervention 2: 5 mg Bupivacaine
Intervention descriptions: intervention 1: 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space intervention 2: 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT03645863
Conditions: Healthy
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2018-08-27; Completion date: 2018-09-30
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objectives of this study are to investigate the pharmacokinetics and safety of MT-6548 co-administered with iron supplements in healthy male volunteers.

Detailed description:

Arms: arm 1: Subject will receive MT-6548 on Day 1, 4, and 7. Subject will receive Iron supplement A on Day 1, 4, or 7. Subject will receive Iron supplement B on Day 1, 4, or 7. arm 2: Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement C on Day 1 or 4. arm 3: Subject will receive MT-6548 on Day 1 and 4. Subject will receive Iron supplement D on Day 1 or 4.
Interventions: intervention 1: MT-6548 intervention 2: Iron supplement A intervention 3: Iron supplement B intervention 4: Iron supplement C intervention 5: Iron supplement D
Intervention descriptions: intervention 1: Oral tablet intervention 2: Oral tablet intervention 3: Oral tablet intervention 4: Oral tablet intervention 5: Oral tablet

Protocol documents:
Prot_000.pdf: 



























































































































































SAP_001.pdf:
Clinical trial NCT02162667
Conditions: HER2-positive Carcinoma of Breast
Sponsor: Celltrion
Start date: 2014-06-01; Completion date: 2018-10-01
Enrollment: 562 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine whether CT-P6 and Herceptin are equivalent in patients with early-stage breast cancer undergoing neoadjuvant chemotherapy. Our hypothesis is that the pathologic complete response rate will be equivalent in patients treated with neoadjuvant CT-P6 or Herceptin. Patients will receive 8 cycles of neoadjuvant systemic therapy and up to 10 cycles of therapy in the adjuvant setting.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Trastuzumab
Intervention descriptions: intervention 1: Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.

Protocol documents:
Clinical trial NCT00075764
Conditions: Breast Cancer
Keywords: stage IV breast cancer recurrent breast cancer
Sponsor: SWOG Cancer Research Network
Start date: 2004-04-01; Completion date: 2018-10-01
Enrollment: 695 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using drugs such as anastrozole and fulvestrant may fight breast cancer by blocking the use of estrogen. It is not yet known whether anastrozole is more effective with or without fulvestrant in treating breast cancer.

PURPOSE: This randomized phase III trial is studying giving anastrozole together with fulvestrant to see how well it works compared to anastrozole alone as first-line therapy in treating postmenopausal women with metastatic breast cancer.

Detailed description:
OBJECTIVES:

* Compare the time to tumor progression in postmenopausal women with metastatic breast cancer treated with anastrozole with or without fulvestrant as first-line therapy.
* Compare the clinical benefit (complete or partial response, confirmed or unconfirmed, or stable disease ≥ 24 weeks) and overall survival of patients treated with these regimens.
* Compare adverse events in patients treated with these regimens.
* Determine the prognostic significance of estrogen receptor positivity and HER2/neu status in patients treated with these regimens.
* Determine parameters of estrogen and clinical pharmacology and estrogen levels in patients treated with these regimens.
* Compare anastrozole plasma levels at 8, 16, and 24 weeks in patients treated with these regimens (closed as of 4/16/2009).
* Compare estradiol serum levels at 8, 16, and 24 weeks in patients treated with these regimens (closed as of 4/16/2009).

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior adjuvant tamoxifen therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral anastrozole once daily on days 1-28.
* Arm II: Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed for up to 4 years.

PROJECTED ACCRUAL: A total of 690 patients (345 per treatment arm) will be accrued for this study within 3 years.

Arms: arm 1: Patients receive oral anastrozole once daily on days 1-28. arm 2: Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.
Interventions: intervention 1: anastrozole intervention 2: fulvestrant
Intervention descriptions: intervention 1: Given orally intervention 2: Given intramuscularly

Protocol documents:
Clinical trial NCT02686749
Conditions: Congestive Heart Failure Left Ventricular Failure Atrial Fibrillation
Sponsor: The Cleveland Clinic
Start date: 2016-06-01; Completion date: 2018-10-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a multi-center, randomized, unblinded, clinical trial. The objective is to determine if catheter-based atrial fibrillation (AF) ablation is superior to medical treatment in patients with impaired left ventricular (LV) function who have been diagnosed with symptomatic AF within the past 12 months.

Detailed description:
The purpose of the trial is to compare two different approved treatments for recently diagnosed AF: anti-arrhythmic medications and AF ablation. The study will be conducted to determine if one treatment is more effective than the other for patients with AF and heart failure. About 220 subjects with newly diagnosed AF from hospitals in the United States will take part in this study. Subjects will be randomized in a 1:1 fashion to either AF catheter ablation or anti-arrhythmic medication for treatment of AF. Both therapies are considered Standard of Care.

Arms: arm 1: Pulmonary Vein Isolation catheter ablation for treatment of AF. AF catheter ablation is an FDA approved treatment for AF arm 2: FDA approved anti arrhythmic drug for the treatment of AF will be based on treating physicians' preference in accordance to guidelines.
Interventions: intervention 1: Catheter Ablation intervention 2: FDA approved anti arrhythmic drug
Intervention descriptions: intervention 1: During ablation, a doctor inserts a catheter through blood vessels into the heart. The doctor looks at the electrical activity of the heart. The catheter is used to determine which areas of the heart are causing AF. After the area is identified, the doctor uses a special machine delivers energy through the catheter to tiny areas of the heart muscle that is causing AF. This energy causes a scar in the tissue which "disconnects" the pathway of the AF. intervention 2: Anti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01797445
Conditions: HIV HIV Infections
Keywords: HIV Treatment Naive HIV 1 Infected Women Female
Sponsor: Gilead Sciences
Start date: 2013-03-12; Completion date: 2018-10-03
Enrollment: 872 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults.

Detailed description:

Arms: arm 1: E/C/F/TAF plus E/C/F/TDF placebo for 144 weeks

After 144 weeks, participants will continue to take their blinded study drug until treatment assignments have been unblinded. arm 2: E/C/F/TDF plus E/C/F/TAF placebo for 144 weeks

After 144 weeks, participants will continue to take their blinded study drug until treatment assignments have been unblinded. arm 3: After the unblinding visit, in countries where E/C/F/TAF is not commercially available, participants (except in UK) who complete 144 weeks of study will be given the option to receive open-label E/C/F/TAF and attend study visits every 12 weeks until it becomes commercially available, or until Gilead terminates the study in that country.
Interventions: intervention 1: E/C/F/TAF intervention 2: E/C/F/TDF intervention 3: E/C/F/TDF Placebo intervention 4: E/C/F/TAF Placebo
Intervention descriptions: intervention 1: 150/150/200/10 mg FDC tablet administered orally once daily intervention 2: 150/150/200/300 mg FDC tablet administered orally once daily intervention 3: Tablet administered orally once daily intervention 4: Tablet administered orally once daily

Protocol documents:
Clinical trial NCT01905943
Conditions: Chronic Lymphocytic Leukemia
Sponsor: Hoffmann-La Roche
Start date: 2013-11-04; Completion date: 2018-10-08
Enrollment: 979 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This multicenter, open-label, single-arm study will evaluate the safety and efficacy of obinutuzumab alone or in combination with chemotherapy in participants with previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). This is a Post-Authorization Safety Study. Participants will receive 6 cycles of single-agent obinutuzumab or obinutuzumab in combination with chemotherapy at the investigator's discretion. Each participant will be followed until 30 months after the last participant has been enrolled. Total length of the study is anticipated to be approximately 5 years.

Detailed description:

Arms: arm 1: Participants will receive obinutuzumab either alone as single agent or in combination with chemotherapy (Fludarabine/Cyclophosphamide \[FC\], Bendamustine or Chlorambucil) at the investigator's discretion. Each cycle is of 28-days duration.
Interventions: intervention 1: Bendamustine intervention 2: Chlorambucil intervention 3: Cyclophosphamide intervention 4: Fludarabine intervention 5: Obinutuzumab
Intervention descriptions: intervention 1: Bendamustine: 90 milligram per millilitre square (mg/m\^2) IV over 60 minutes once daily (QD) Day 1-2 in participants previously untreated or 70 mg/m\^2 I.V. over 60 minutes QD Day 1-2 in participants with relapsed/refractory disease. In non-fit participants only, investigators may opt at their own discretion to use lower initial doses of bendamustine, i.e., bendamustine 70 mg/m\^2 in previously untreated participants, and bendamustine 50 mg/m\^2 in relapsed/refractory subjects (over 60 minutes qd Day 1-2 for each administration). intervention 2: Chlorambucil 0.5 mg/kg p.o. qd on Day 1 and Day 15 in non-fit participants only. intervention 3: Cyclophosphamide 250 mg/m\^2 I.V. over 15-30 minutes qd Day 1-3 or Cyclophosphamide 250 mg/m\^2 p.o. QD Day 1-3 in fit participants only. intervention 4: Fludarabine 25 mg/m\^2 I.V. over 30 minutes QD Day 1-3 or Fludarabine 40 mg/m\^2 per os (p.o.) QD Day 1-3 in fit participants only. intervention 5: Participants will receive obinutuzumab 1000 mg IV infusion on Days 1/2 (dose split over 2 consecutive days; 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1, and on Day 1 of Cycles 2, 3, 4, 5, and 6. Each cycle is of 28-days duration.

Protocol documents:
Clinical trial NCT00451555
Conditions: Breast Cancer
Sponsor: Eli Lilly and Company
Start date: 2007-04-11; Completion date: 2018-10-18
Enrollment: 156 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to help answer the following research question: whether enzastaurin given together with fulvestrant can help participants who have breast cancer and make the tumor smaller or disappear and for how long.

Detailed description:

Arms: arm 1: Participants received Enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 500 mg orally (QD) once daily in a 28-day cycle.

Participants received enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 250 mg orally (BID) twice daily in a 28-day cycle.

Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter. arm 2: Participants received fulvestrant: 500 mg, IM, day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression. Then, participants received placebo, oral, daily.
Interventions: intervention 1: enzastaurin intervention 2: placebo intervention 3: fulvestrant
Intervention descriptions: intervention 1: 1125 milligram (mg) loading dose then 250 mg, oral, twice daily (for a total of 500 mg), until disease progression intervention 2: oral, daily intervention 3: 500 mg, intramuscular (IM), day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression

Protocol documents:
Clinical trial NCT02102490
Conditions: Metastatic Breast Cancer
Keywords: Endocrine Therapy, Taxane, MONARCH 1
Sponsor: Eli Lilly and Company
Start date: 2014-06-10; Completion date: 2018-10-22
Enrollment: 132 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to evaluate whether the study drug known as abemaciclib is effective in treating participants with breast cancer who have already tried other drug treatments.

Detailed description:

Arms: arm 1: 200 milligrams (mg) abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Interventions: intervention 1: Abemaciclib
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT03441789
Conditions: Plaque Psoriasis
Sponsor: L.H. Kircik, M.D.
Start date: 2017-09-18; Completion date: 2018-10-22
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study seeks to show whether there is a benefit of prescribing Enstilar with Otezla in the treatment of patients with moderate plaque type psoriasis. Subjects will be randomized to study treatment at a 1:1 ratio of Otezla plus Enstilar foam versus Otezla plus vehicle foam.

Detailed description:
Approximately 50 subjects from 4 sites will be enrolled in this investigator-blind study. Subjects will be randomized 1:1 to Otezla plus Enstilar foam or Otezla plus vehicle foam and all adverse events and concomitant medications will be recorded.

Subjects will attend a screening visit/baseline visit and those with plaque-type psoriasis who have been started on commercial Otezla in the last 7 days will be randomized to study treatment as outlined above.

Enstilar or the vehicle will be initiated for the first 4 weeks and then Otezla will be continued as monotherapy for the next 8 weeks. Enstilar or the vehicle will be reinitiated for the last 4 weeks of the study. Total study period is 16 weeks and study visits will occur as follows: screening/baseline, week 1, 2, 3, 4, week 12, and week 16. Study assessments at each visit will be PASI, BSA, PGA, Itch VAS, DLQI, and standard medical assessments. There will be standard medication/treatment and washout periods.

Arms: arm 1: Subjects randomized to this group will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily arm 2: Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily
Interventions: intervention 1: Enstilar intervention 2: Vehicle intervention 3: Otezla
Intervention descriptions: intervention 1: Enstilar foam applied to affected areas daily intervention 2: vehicle foam applied to affected areas once daily intervention 3: Otezla 30mg

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT04029090
Conditions: Healthy Adult Subjects
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2018-09-18; Completion date: 2018-10-23
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To evaluate the effect of MCI-186 on the QT interval corrected for heart rate using Fridericia's formula (QTcF)

Detailed description:

Arms: arm 1: Subjects will receive a single intravenous dose of MCI-186 as a 1-hour infusion in the treatment sequence: first Treatment A, then Treatment C, then Treatment B (Treatment A= 60 mg of MCI-186, Treatment B= 300 mg of MCI-186, treatment C=0.9% w/v saline) arm 2: Subjects will receive a single intravenous dose of MCI-186 as a 1-hour infusion in the treatment sequence: first Treatment B, then Treatment A, then Treatment C (Treatment A= 60 mg of MCI-186, Treatment B= 300 mg of MCI-186, treatment C=0.9% w/v saline) arm 3: Subjects will receive a single intravenous dose of MCI-186 as a 1-hour infusion in the treatment sequence: first Treatment C, then Treatment B, then Treatment A (Treatment A= 60 mg of MCI-186, Treatment B= 300 mg of MCI-186, treatment C=0.9% w/v saline)
Interventions: intervention 1: MCI-186 intervention 2: MCI-186 intervention 3: Placebo
Intervention descriptions: intervention 1: A single dose of 60 mg MCI-186 over 60 min will be intravenously administered. intervention 2: A single dose of 300 mg MCI-186 over 60 min will be intravenously administered. intervention 3: A single dose of 0.9% w/v saline over 60 min will be intravenously administered.

Protocol documents:
Prot_000.pdf: 





















































































































SAP_001.pdf:
Clinical trial NCT01583374
Conditions: Ankylosing Spondyloarthritis
Keywords: spondylitis spondyloarthritis Spondyloarthropathy Oral preparation
Sponsor: Amgen
Start date: 2012-05-02; Completion date: 2018-10-25
Enrollment: 490 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Apremilast is a new, orally available, small molecule drug that specifically inhibits phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.

Detailed description:
Patients were randomized in a 1:1:1 ratio to placebo, apremilast 20 mg BID and apremilast 30 mg BID. The duration of the study was approximately 5 years. The double blind period (when patients nor the physician knew whether placebo or apremilast was taken) was 24 weeks. At Week 16, participants who did not have either a ≥ 20% improvement or a ≥ 1 unit improvement from baseline in at least two of the four SpondyloArthritis international Society (ASAS) domains were entered in "early escape" from their current treatment in a double-blinded manner. However, such participants were permitted to continue in the study. At Week 24, participants may have entered a long-term extension phase for up to an additional 4.5 years (236 weeks). At "second escape" (at Week 24), apremilast 20 mg BID treated participants transitioned to receive double-blinded apremilast 30 mg BID and remained on double-blinded apremilast 30 mg BID because they continued to improve with a longer duration of treatment. After Week 24 and during the early portion of the long-term extension through Week 52, all participants continued on either double-blinded apremilast 20 mg BID or 30 mg BID treatment. After all participants had completed Week 52 or had terminated early from the study and the 52-week data base was locked, apremilast 20 mg BID or 30 mg BID treatment was provided.

Arms: arm 1: Apremilast 20 mg was taken orally twice a day (BID) arm 2: Apremilast 30 mg was taken orally twice a day arm 3: Identically matched placebo tablets were taken orally twice a day
Interventions: intervention 1: Apremilast tablet 20 mg intervention 2: Apremilast tablet 30 mg BID intervention 3: Placebo
Intervention descriptions: intervention 1: Apremilast 20 mg was taken orally twice a day (BID) intervention 2: Apremilast 30 mg was taken orally twice a day intervention 3: Identically matched placebo tablets were taken orally twice a day during the placebo controlled phase.

Protocol documents: