ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01841931
Conditions: Opioid Use Disorder
Keywords: Opioids Dependence Buprenorphine Pain
Sponsor: Maimonides Medical Center
Start date: 2013-02-01; Completion date: 2013-08-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to examine whether buprenorphine can be at least as effective as other opioid medications in relieving chronic pain in patients who suffer from dependence on their opioid medications, while patients simultaneously experience progressive decline of pain along with absence of opioid withdrawal symptoms and improved quality of life.

Detailed description:
The study will utilize sublingual buprenorphine for the treatment of chronic pain patients with co-occurring opioid dependence. Adult male and female chronic pain patients with co-occurring opioid dependence/disorder, being treated at MMC will be enrolled in a home induction procedure. Subjects will be switched from their current opioid pain medication to buprenorphine/naloxone to assess whether buprenorphine is at least as effective, if not more effective, as other opioid medications in controlling their pain while simultaneously improving their psychological distress, functional status, and other aspects of patients' lives. We will utilize a home induction procedure, and maintain subjects on this oral medication for a duration of 6 months. During this period

Interventions: intervention 1: Buprenorphine/Naloxone
Intervention descriptions: intervention 1: Sublingual buprenorphine/naloxone taken in a 3 day induction, with a final daily dose (up to 32 mg depending on the subject) taken daily, as prescribed by the study psychiatrist. Subjects will continue buprenorphine for study duration (6 months).

Protocol documents:
Clinical trial NCT01845077
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-05-01; Completion date: 2013-08-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing linagliptin \& metformin and the single tablets of linagliptin and metformin when administered singularly.

Detailed description:

Arms: arm 1: 3 single tablets under fed conditions arm 2: 2 FDC tablets under fasted conditions arm 3: 4 single tablets under fasted conditions arm 4: 1 fixed dose combination(FDC) tablet under fasted conditions arm 5: 3 single tablets under fasted conditions arm 6: 1 FDC tablet under fed conditions
Interventions: intervention 1: 2x500 mg Metformin (Glumetza) intervention 2: 5 mg Linagliptin/1000 mg Metformin FDC intervention 3: 5 mg Linagliptin (Tradjenta) intervention 4: 5 mg Linagliptin (Tradjenta) intervention 5: 3x500 mg Metformin (Glumetza) intervention 6: 5 mg Linagliptin (Tradjenta) intervention 7: 2 x 500 mg Metformin (Glumetza) intervention 8: 5 mg Linagliptin/1000mg Metformin FDC intervention 9: 2 x 2.5 mg Linagliptin/750 mg Metformin FDC
Intervention descriptions: intervention 1: 2 tablets intervention 2: FDC tablet intervention 3: 1 tablet intervention 4: 1 tablet intervention 5: 3 tablets intervention 6: 1 tablet intervention 7: 2 tablets intervention 8: FDC Tablet intervention 9: 2 FDC tablets

Protocol documents:
Clinical trial NCT01856530
Conditions: Social Anxiety Disorder
Sponsor: Stefan G. Hofmann
Start date: 2012-07-01; Completion date: 2013-08-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn more about how the hormone, oxytocin, impacts social behavior in terms of cooperation with others, attention processing, and reward processing, among patients with social anxiety disorder. Based on available research, the investigators predict that in patients with social anxiety disorder, oxytocin will improve social cooperation during an online ball-tossing game called Cyberball, reduce attention toward socially threatening cues during a dot-probe task, and lead to greater willingness to work for monetary rewards for others rather than themselves during an effort expenditure task.

Detailed description:

Arms: arm 1: Liquid intranasal oxytocin, 24 IU, administered once arm 2: Matched placebo nasal spray
Interventions: intervention 1: Oxytocin intervention 2: Placebo
Intervention descriptions: intervention 1: Liquid metered-dose nasal spray, 24 IU, administered once intervention 2: Matched placebo nasal spray

Protocol documents:
Clinical trial NCT01859078
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-05-01; Completion date: 2013-08-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the effect of baricitinib on the levels of digoxin in the blood stream and how long it takes the body to remove digoxin. This study will also look at how safe and well-tolerated baricitinib is when given at the same time as digoxin in healthy participants. This study will last approximately 3-4 weeks.

Detailed description:

Arms: arm 1: Digoxin - 0.5 milligrams (mg) administered orally, twice daily (BID), 12 hours apart on Day 1. Then, 0.25 mg administered orally, once daily (QD) on Days 2 through 16.

Baricitinib - 10 mg administered orally, QD, on Days 8 through 16.
Interventions: intervention 1: Baricitinib intervention 2: Digoxin
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT01866709
Conditions: Hyperkalemia
Sponsor: ZS Pharma, Inc.
Start date: 2013-05-01; Completion date: 2013-08-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
It is hypothesized that SPS is more effective than placebo control (alternative hypothesis) in lowering i-STAT potassium levels in subjects with i-STAT potassium levels between 5.0 - 6.5 mmol/l versus no difference between SPS and placebo control (null hypothesis).

Detailed description:
Subjects with mild to moderate hyperkalemia (i-STAT potassium levels between 5.0-6.5 mmol/l, inclusive) will be randomized 1:1 in a double-blind fashion to receive placebo or SPS (15g), administered tid with meals for 48 hours. Subjects will come back to the clinic on Study Day 9 for an End of Study (EOS) visit. Adverse experiences will be recorded.

Blood potassium levels will be evaluated by both i-STAT and the Local Laboratory prior to the first dose on Study Days 1 and 2, 1, 2, and 4 hours after the first dose on Study Day 1, 1 and 4 hours after the first dose on Study Day 2 and prior to breakfast on Study Day 3, after 48 hours of treatment.

Subjects who have i-STAT potassium levels \> 6.5 mmol/l on Study Day 1 at the 4 hour post Dose 1 time point will be withdrawn from the study and will receive standard of care. If the i-STAT potassium value is between 6.1 and 6.5 mmol/l at the 4-hour post Dose 1 draw, subjects will be kept in the clinic for another 90 minutes post Dose 2 and another blood draw will be taken and an ECG will be performed. If the i-STAT potassium level is ≥ 6.2 mmol/l at this time point, the subject will be discontinued from the study and standard of care will be instituted. If the i-STAT potassium level is \< 6.2 mmol/l, and the ECG does not show any of the ECG withdrawal criteria (see below), the subject will continue in the study.

Arms: arm 1: Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol. arm 2: Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.
Interventions: intervention 1: Sodium polystyrene sulfonate intervention 2: Silicified microcrystalline cellulose
Intervention descriptions: intervention 1: Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol. intervention 2: Oral suspension in water of placebo administered three times (tid) daily for 48 hours.

Protocol documents:
Clinical trial NCT01902758
Conditions: Acute Mountain Sickness
Keywords: exercise performance
Sponsor: University of Montana
Start date: 2013-08-01; Completion date: 2013-08-01
Enrollment: 28 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to determine the effectiveness of using two FDA approved medications in concert to reduce the likelihood of sickness due to low oxygen levels and to reduce the decrement in physical performance at higher elevations. The investigators hypothesize that this drug combination will reduce the symptoms of acute mountain sickness and improve exercise performance at high altitude compared to placebo.

Detailed description:

Arms: arm 1: ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days arm 2: matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group
Interventions: intervention 1: ambrisentan and theophylline intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: placebo for comparison group

Protocol documents:
Clinical trial NCT02569996
Conditions: Lymphoma, Follicular
Sponsor: Hoffmann-La Roche
Start date: 2005-07-01; Completion date: 2013-08-01
Enrollment: 124 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy, safety, and tolerability of long-term maintenance therapy with rituximab in participants with advanced follicular lymphoma who have had a positive response to first-line treatment with a rituximab-containing regimen. The anticipated time on study treatment is 2 years, and the target sample size is 124 individuals.

Detailed description:

Arms: arm 1: Participants will receive rituximab 375 milligrams per meter square (mg/m\^2) every 8 weeks for 24 months or until progression, relapse, death, or institution of a new anti-lymphoma treatment.
Interventions: intervention 1: Rituximab
Intervention descriptions: intervention 1: Rituximab will be administered at 375 mg/m\^2 every 8 weeks for 24 months or until progression, relapse, death, or institution of a new anti-lymphoma treatment.

Protocol documents:
Clinical trial NCT02723630
Conditions: Healthy Volunteers
Keywords: Bioequivalence Lenvatinib Healthy Volunteers Lenvima E7080
Sponsor: Eisai Inc.
Start date: 2013-07-01; Completion date: 2013-08-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This will be a randomized, single dose, open-label, three-treatment period crossover study in healthy participants to determine whether 2 test lots of 10-mg capsules that vary by the level of lenvatinib Type-C crystal are bioequivalent to a reference lot of 10-mg capsules.

Detailed description:
The study will consist of 2 phases: Prerandomization and Randomization. The Prerandomization Phase will have 2 periods: Screening and Baseline. The Randomization Phase will consist of three 6-day long Treatment Periods with each Treatment Period separated by a 1-day long Baseline. Sixty participants will be evenly randomized to 1 of 6 possible treatment sequences (A, B, C, D, E, or F). The 3 treatments vary by the level of crystalline polymorph Type-C present in the drug product batch used in each arm, respectively: Treatment 1 - low Type-C crystal level less than 12%; Treatment 2 - reference Type-C crystal level 12% to 26%; and Treatment 3 - high Type-C crystal level greater than 26%.

Arms: arm 1: Participants will receive one dose of Treatment 1 followed by one dose of Treatment 2, then one dose of Treatment 3 arm 2: Participants will receive one dose of Treatment 2, followed by one dose of Treatment 3, then one dose of Treatment 1 arm 3: Participants will receive one dose of Treatment 3, followed by one dose of Treatment 1, then one dose of Treatment 2 arm 4: Participants will receive one dose of Treatment 3, followed by one dose of Treatment 2, then one dose of Treatment 1 arm 5: Participants will receive one dose of Treatment 1, followed by one dose of Treatment 3, then one dose of Treatment 2 arm 6: Participants will receive one dose of Treatment 2, followed by one dose of Treatment 1, then one dose of Treatment 3
Interventions: intervention 1: Lenvatinib 10 mg
Intervention descriptions: intervention 1: Treatment 1: low Type-C crystal level \<12%

Treatment 2: reference\* Type-C crystal level 12% to 26%

Treatment 3: high Type-C crystal level \>26%

Protocol documents:
Clinical trial NCT01674621
Conditions: Post Menopausal Osteoporosis
Keywords: BA058 Abaloparatide-SC abaloparatide Abaloparatide-TD Osteo Osteoporosis Transdermal Patch
Sponsor: Radius Health, Inc.
Start date: 2012-09-25; Completion date: 2013-08-02
Enrollment: 250 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the clinical safety and efficacy of abaloparatide transdermal in otherwise healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD) and serum markers of bone metabolism when compared to transdermal placebo and abaloparatide injection for 6 months of treatment.

Detailed description:

Arms: arm 1: Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months arm 2: Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months arm 3: Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months arm 4: Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months arm 5: Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
Interventions: intervention 1: Abaloparatide Transdermal (50 mcg) intervention 2: Abaloparatide Transdermal (100 mcg) intervention 3: Abaloparatide Transdermal (150 mcg) intervention 4: Abaloparatide Injection (80 mcg) intervention 5: Abaloparatide Placebo
Intervention descriptions: intervention 1: Abaloparatide Transdermal Microneedle Active Patch intervention 2: Abaloparatide Transdermal Microneedle Active Patch intervention 3: Abaloparatide Transdermal Microneedle Active Patch intervention 4: Abaloparatide Subcutaneous Injection intervention 5: Abaloparatide Transdermal Microneedle Placebo Patch

Protocol documents:
Clinical trial NCT00477750
Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Keywords: stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma
Sponsor: Mayo Clinic
Start date: 2005-06-01; Completion date: 2013-08-05
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as melphalan, prednisone, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of melphalan and lenalidomide when given together with prednisone and to see how well they work in treating patients with newly diagnosed multiple myeloma.

Detailed description:
OBJECTIVES:

Primary

* Determine the maximum tolerated dose of melphalan and lenalidomide in combination with prednisone in patients with newly diagnosed multiple myeloma.
* Determine the response rate in patients treated with this regimen. Secondary
* Determine the toxicity of this regimen in these patients. OUTLINE: This is a dose-escalation study of melphalan and lenalidomide followed by a phase II study.
* Phase I: Patients receive oral melphalan and oral prednisone daily on days 1-4. Patients also receive oral lenalidomide daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of melphalan and lenalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

\* Phase II: Patients receive oral melphalan and oral lenalidomide as in phase I at the MTD. Patients also receive oral prednisone as in phase I. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 3 years.

Arms: arm 1: Intervention: Drug: lenalidomide Dose determined by Phase I treatment schedule. Taken orally days 1-21 every 28 days until progression

Intervention: Drug: melphalan Dose determined by Phase I treatment schedule. Taken orally days 1-4 every 28 days until progression

Intervention: Drug: prednisone 60mg/m\^2, orally days 1-4 every 28 days until progression
Interventions: intervention 1: lenalidomide intervention 2: melphalan intervention 3: prednisone
Intervention descriptions: intervention 1: Phase I - dose escalating: 5mg level -1, 10mg level 0, 10mg level 1, 15mg level 2, 20mg level 3, 25mg level 4, orally days 1-21 every 28 days until progression

Phase II - 10 mg orally days 1-21 every 28 days until progression intervention 2: Phase I - dose escalating: 5mg/m\^2 dose level -1, 5 mg/m\^2 dose level 0, 8 mg/m\^2 dose level 1 - 4, daily x 4 orally days every 28 days until progression

Phase II - 5mg/m\^2 orally days 1-4 every 28 days until progression intervention 3: 60mg/m\^2, orally days 1-4 every 28 days until progression

Protocol documents:
Clinical trial NCT01483599
Conditions: Psoriasis
Keywords: Moderate to Severe Plaque-Type Psoriasis Psoriasis Plaque-type psoriasis CNTO 1959 adalimumab
Sponsor: Janssen Inc.
Start date: 2011-11-10; Completion date: 2013-08-05
Enrollment: 293 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of CNTO 1959 in the treatment of patients with moderate to severe plaque psoriasis.

Detailed description:
This is a multicenter, dose-ranging study of CNTO 1959 in patients with moderate to severe plaque psoriasis. Patients who satisfy all inclusion and exclusion criteria will be assigned by chance to one of 7 treatment groups: a placebo group (a placebo is a treatment identical in appearance to CNTO 1959 but does not contain active drug), 1 of 5 dose groups for CNTO 1959, or adalimumab. Patients assigned to adalimumab will be dosed according to the labeled dosing for psoriasis. At Week 16, patients initially assigned to placebo will begin receiving CNTO 1959. Patients initially assigned to CNTO 1959 will continue to receive the same assigned dose level of study agent from Week 16 through Week 40. Patients receiving adalimumab will continue the labeled dosing regimen. All patients will be reassessed for clinical response every 4 weeks from Week 4 through Week 40. Patients will continue dosing through Week 40, with a subsequent efficacy and safety follow-up visit at Week 52. Patient safety will be monitored throughout the study.

Arms: arm 1: CNTO 1959 5 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40 arm 2: CNTO 1959 15 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40 arm 3: CNTO 1959 50 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40 arm 4: CNTO 1959 100 mg at weeks 0, 8, and 16, then every 8 weeks through Week 40 arm 5: CNTO 1959 200 mg at weeks 0, 4, and 16, then every 12 weeks through Week 40 arm 6: Adalimumab 80 mg at week 0 followed by 40 mg at week 1 and every second week through Week 39 (i.e., Weeks 3, 5, 7, etc.) arm 7: Placebo at weeks 0, 4, and 8; then crossover to CNTO 1959 100 mg at Week 16, then every 8 weeks through Week 40
Interventions: intervention 1: CNTO 1959 (5 mg) intervention 2: CNTO 1959 (15 mg) intervention 3: CNTO 1959 (50 mg) intervention 4: CNTO 1959 (100 mg) intervention 5: CNTO 1959 (200 mg) intervention 6: Adalimumab intervention 7: Placebo
Intervention descriptions: intervention 1: Subcutaneous (SC) injections intervention 2: SC injections intervention 3: SC injections intervention 4: SC injections intervention 5: SC injections intervention 6: SC injections intervention 7: SC injections

Protocol documents:
Clinical trial NCT01031420
Conditions: Muscle Invasive Bladder Cancer High Risk Urothelial Carcinoma of the Upper Urinary Tracts
Keywords: bladder cancer invasive
Sponsor: Fox Chase Cancer Center
Start date: 2009-12-07; Completion date: 2013-08-07
Enrollment: 54 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Standard treatment for early stage bladder cancer is chemotherapy with methotrexate (M), vinblastine (V), adriamycin (A), and cisplatin (C) followed by surgical removal of any remaining cancer and the bladder with the intent of cure. The M V chemotherapy is usually given every 14 days with the AC given along each 28 days. This study looks at giving the same drugs at the same doses closer together, all drugs every 14 days, with the support of growth factor medication to promote growth of the white blood cells and platelets and allow chemotherapy to be finished sooner and surgery to be done sooner.

Detailed description:
Primary Objective To assess the rate of complete response (pT0) at cystectomy or ureterectomy following preoperative dose dense MVAC (DD-MVAC) in patients with muscle invasive urothelial carcinoma of the bladder or high grade upper tract urothelial carcinoma.

Secondary Objectives To assess the toxicity profile of DD-MVAC when given in the neoadjuvant setting: To define the number of patients who complete all three cycles of treatment without dose reduction, and to compare incidence of toxicity to the historical standard described by Grossman et al. To assess the 5 year overall and relapse free survival in patients who receive neoadjuvant DD-MVAC. To compare complete response rates between the following subgroups of study patients: Among bladder patients: Clinical N0 versus N1 (Appendix B) Among bladder patients: T2 stage without high risk features versus T2 with high risk features plus those with \> T2 stage.

Three 14 day cycles of:

Methotrexate 30 mg/m2 IV push or infusion over 2-3 minutes. Day 1

Vinblastine 3 mg/m2 Slow IV push or infusion over Day 1

Doxorubicin 30 mg/m2 Slow IV push or infusion over 15 minutes Day 1

Cisplatin 70 mg/m2 IV infusion over 4 hours Note: May divide dose over two sequential days (35 mg/m2/d x 2 days) if creatinine clearance 50-59 mL/min Day 1\* (or divided over Day 1 and Day 2)

Pegfilgrastim 6 mg subcutaneous (SQ) 24-48 hours after completion of chemotherapy.

Followed in 4-8 weeks by radical cystectomy/ureterectomy.

Arms: arm 1: standard doses of MVAC given every 14 days x 3.
Interventions: intervention 1: single arm dose dense MVAC
Intervention descriptions: intervention 1: standard doses of methotrexate, vinblastine, adriamycin, and cisplatin given every 14 days.

Protocol documents:
Clinical trial NCT03649750
Conditions: Healthy Subjects
Sponsor: Reckitt Benckiser LLC
Start date: 2013-05-29; Completion date: 2013-08-07
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Determine and compare the plasma concentrations of Mucinex® Extended Release (ER) 600 mg bi-layer tablet in normal healthy volunteers in fed and fasting conditions

Detailed description:

Arms: arm 1: Mucinex® 600 mg ER bi-layer tablet by mouth after 10 hours fasting and subject will fast at least 4 hours post-dose arm 2: Mucinex® 600 mg ER bi-layer tablet by mouth in fed condition. After an overnight fast of at least 10 hours, subjects will consume a high fat, high calorie breakfast starting 30 minutes prior to drug administration
Interventions: intervention 1: Mucinex®
Intervention descriptions: intervention 1: Mucinex® 600 mg ER bi-layer tablets

Protocol documents: