ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02277743
Conditions: Dermatitis, Atopic
Sponsor: Regeneron Pharmaceuticals
Start date: 2014-10-01; Completion date: 2016-02-01
Enrollment: 671 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).

Detailed description:

Arms: arm 1: Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection once weekly (qw) from Week 1 to Week 15. arm 2: Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15. arm 3: Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
Interventions: intervention 1: Dupilumab intervention 2: Placebo (for Dupilumab)
Intervention descriptions: intervention 1: Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms intervention 2: Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms

Protocol documents:
Clinical trial NCT02287376
Conditions: Migraine
Keywords: Migraine with and without aura
Sponsor: Depomed
Start date: 2015-01-01; Completion date: 2016-02-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study Objectives:

1. The primary objective is to characterize the pharmacokinetics of a single oral administration of 50 mg Cambia in pediatric subjects, ages 12-17 years with a diagnosis of episodic migraine with or without aura.
2. The secondary objectives are to determine:

   1. The safety and tolerability of Cambia from a single dose
   2. Three-month safety evaluation of Cambia in outpatient usage in this population

Detailed description:

Arms: arm 1: Diclofenac Potassium for Oral Solution 50 mg
Interventions: intervention 1: Diclofenac Potassium for Oral Solution
Intervention descriptions: intervention 1: NSAID

Protocol documents:
Clinical trial NCT02294474
Conditions: Type 2 Diabetes Mellitus
Sponsor: Sanofi
Start date: 2015-01-01; Completion date: 2016-02-01
Enrollment: 505 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

To demonstrate non-inferiority of SAR342434 versus Humalog in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 2 diabetes mellitus (T2DM) also using insulin glargine.

Secondary Objectives:

To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study; To assess the relationship of anti-insulin antibodies with efficacy and safety. To assess the efficacy of SAR342434 and Humalog on: proportion of participants reaching target HbA1c \<7.0% and \<=6.5%, fasting plasma glucose (FPG) and self-measured plasma glucose (SMPG) profiles, and insulin dose.

To assess safety of SAR342434 and Humalog.

Detailed description:
The study will consist of a: up to 2 weeks screening period, 26-week treatment period, and 1-day follow-up period.

The maximum study duration will then be 28 weeks per participant and a 1-day safety follow-up.

Arms: arm 1: SAR342434 100 Unit/mL (U/mL) before meals intake on top of once daily (QD) Insulin Glargine, up to Week 26. arm 2: Humalog 100 U/mL before meals intake on top of QD Insulin Glargine, up to Week 26.
Interventions: intervention 1: SAR342434 intervention 2: Humalog intervention 3: insulin glargine HOE901
Intervention descriptions: intervention 1: SAR342434 100 U/mL (dose range of 1 Unit to 80 Units) self-administered by subcutaneous (SC) injection, immediately (within 5 -10 minutes) before meals intake. Dose adjusted to achieve 2 hour post prandial glucose (PPG) in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycemia. intervention 2: Humalog 100 U/ml (dose range of 1 unit to 60 units) self-administered by SC injection, immediately (within 5-10 minutes) before meals intake. Dose adjusted to achieve a 2 hour PPG in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycemia. intervention 3: Insulin glargine 100 U/mL injected QD subcutaneously consistent with the local label. Doses adjusted to achieve glycemic target for fasting, preprandial plasma glucose (SMPG) between 4.4 to 7.2 mmol/L (80 to 130 mg/dL) without hypoglycemia.

Protocol documents:
Clinical trial NCT02303548
Conditions: Cardiac Arrest Metabolic Acidosis
Keywords: Sodium Bicarbonate
Sponsor: Asan Medical Center
Start date: 2014-10-01; Completion date: 2016-02-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A pilot study to evaluate the effect of sodium bicarbonate administration on cardiopulmonary resuscitation results and outcomes in cardiac arrest patient with severe metabolic acidosis.

Detailed description:

Arms: arm 1: Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min arm 2: Normal saline 50cc intravenous injection over 2 min
Interventions: intervention 1: Sodium bicarbonate intervention 2: Normal saline
Intervention descriptions: intervention 1: Administer Sodium bicarbonate 50 mEq IV over 2 minutes intervention 2: Placebo

Protocol documents:
Clinical trial NCT02310750
Conditions: Plaque Psoriasis
Sponsor: Pfizer
Start date: 2014-11-01; Completion date: 2016-02-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of the study is to determine if PF-06700841 is safe and well tolerated when administered to humans. A secondary purpose is to assess what the body does to PF-06700841 and to assess what PF-06700841 does to the body when given as single and multiple doses. The pharmacokinetic properties of different forms of PF-06700841 may be studied (tablet and solution/suspension forms).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: Oral placebo comparator for the healthy subject single and multiple ascending dose periods, and the psoriasis multiple dose period. No placebo used for the bioavailability investigation.
Interventions: intervention 1: PF-06700841 oral solution/suspension intervention 2: Placebo intervention 3: PF-06700841 tablet
Intervention descriptions: intervention 1: Oral solution or suspension of study drug PF-06700841 (once daily or twice daily during multiple dosing periods) intervention 2: Matching placebo given during the single ascending and multiple dose periods intervention 3: PF-06700841 tablet formulation administered during the bioavailability / food effect investigation

Protocol documents:
Clinical trial NCT02311881
Conditions: Pain
Sponsor: GlaxoSmithKline
Start date: 2015-01-01; Completion date: 2016-02-01
Enrollment: 960 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether paracetamol 1000 mg sustained-release (SR) tablets administered orally, twice daily are effective and safe in the treatment of patients with osteoarthritis of the knee or hip.

Detailed description:

Arms: arm 1: Participants will be instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces (\~ 240 mL) of water/dose for 12 weeks. arm 2: Participants will be instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces (\~ 240 mL) of water/dose for 12 weeks. arm 3: Participants will be instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces (\~ 240 mL) of water/dose for 12 weeks.
Interventions: intervention 1: Paracetamol 1000 mg SR tablets intervention 2: Paracetamol 665 mg SR tablets intervention 3: Placebo
Intervention descriptions: intervention 1: Two paracetamol 1000 mg SR tablets administered orally two times a day plus two placebo-matched paracetamol 665 mg SR tablets administered orally three times a day for 12 weeks. intervention 2: Two paracetamol 665 mg SR tablets administered orally three times a day plus two placebo-matched paracetamol 1000 mg SR tablets administered orally two times a day for 12 weeks. intervention 3: Two placebo-matched paracetamol 665 mg SR tablets administered orally three times a day plus two placebo-matched paracetamol 1000 mg SR tablets administered orally two times a day for 12 weeks.

Protocol documents:
Clinical trial NCT02314247
Conditions: Peripheral T-cell Lymphoma (PTCL) Cutaneous T-cell Lymphoma (CTCL)
Keywords: PTCL CTCL Peripheral T-cell Lymphoma Cutaneous T-cell Lymphoma Karyopharm KPT-330 Selinexor
Sponsor: Karyopharm Therapeutics Inc
Start date: 2015-02-01; Completion date: 2016-02-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single-arm, multi-center, open-label phase 2 study of the SINE™ compound selinexor given orally to patients with relapsed or refractory PTCL or CTCL.

Approximately 60 patients with relapsed or refractory PTCL or CTCL who meet the eligibility criteria and have none of the exclusion criteria will be enrolled to receive selinexor until either disease progression or intolerance has occurred.

Detailed description:
This is a single-arm, multi-center, open-label phase 2 study of the SINE™ compound selinexor given orally to patients with relapsed or refractory PTCL or CTCL.

Approximately 60 patients with relapsed or refractory PTCL or CTCL who meet the eligibility criteria and have none of the exclusion criteria will be enrolled to receive selinexor until either disease progression or intolerance has occurred.

Enrolled patients will be given selinexor as an oral fixed 60 mg dose (equivalent to \~35 mg/m²) on Days 1 and 3 of Weeks 1-4 of each 4-week cycle (total 8 doses per cycle).

There is no maximum treatment duration. Patients will receive supportive therapy to mitigate selinexor side effects, as well as best supportive care (BSC).

Patients enrolled under Protocol Versions \<3.0 were to receive selinexor orally, at a fixed dose of 60 mg (equivalent to \~35 mg/m²) on Days 1 and 3 of Weeks 1-3 of each 4-week cycle (total of 6 doses per cycle). Selinexor was not taken during Week 4.

For all patients enrolled in this study (regardless of the protocol version) who continued onto Cycle 3 and forward, the dose was to be increased by 20 mg to 80 mg (administered on Days 1 and 3 of Weeks 1-4), only after consultation with the Sponsor's Medical Monitor.

Arms: arm 1: 60 mg dose (equivalent to \~35 mg/m²)
Interventions: intervention 1: Selinexor
Intervention descriptions: intervention 1: 20 mg oral tablets: 60 mg dose on Days 1 and 3 of Weeks 1-4 of each 4-week cycle (Protocol V.3.0).

20 mg oral tablets: 60 mg dose on Days 1 and 3 of Weeks 1-3 of each 4-week cycle (Protocol V.\<3.0).

Number of Cycles: up to 12 but there is no maximal duration for treatment.

Protocol documents:
Clinical trial NCT02354222
Conditions: Type 2 Diabetes Mellitus
Keywords: MT-2412 MP-513 TA-7284 Teneligliptin Canagliflozin
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2015-01-01; Completion date: 2016-02-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of co-administration of Canagliflozin (TA-7284) and Teneligliptin (MP-513) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Canagliflozin and have inadequate glycemic control.

Detailed description:

Arms: arm 1: Patients receive Teneligliptin for 24 weeks in combination with Canagliflozin. arm 2: Patients receive placebo for 24 weeks in combination with Canagliflozin.
Interventions: intervention 1: Canagliflozin intervention 2: Teneligliptin intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02380742
Conditions: Pain
Keywords: Pessary Pain EMLA lidocaine prilocaine
Sponsor: Loyola University
Start date: 2015-07-01; Completion date: 2016-02-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate if lidocaine-prilocaine (EMLA 5%) cream can reduce pain and discomfort at the time of vaginal pessary removal and insertion. Half of the participants will receive lidocaine-prilocaine (EMLA 5%) cream and the other half will receive a placebo cream.

Detailed description:
Lidocaine-prilocaine (EMLA 5%) cream has been shown to be effective in reducing pain during minor gynecologic procedures. The primary objective of this trial is to determine if the use of 5% EMLA cream at the time of pessary removal and insertion reduces pain when compared to the use of placebo cream.

Participants will be randomized to receive either 10 grams of 5% EMLA cream (4 mL) or 4 mL of placebo cream (aqueous cream BP). Cream will be applied in office at the time of pessary removal and insertion.

Arms: arm 1: 4 mL of lidocaine-prilocaine cream arm 2: 4 mL of placebo cream
Interventions: intervention 1: lidocaine-prilocaine cream intervention 2: Placebo cream
Intervention descriptions: intervention 1: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point intervention 2: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point

Protocol documents:
Clinical trial NCT02423408
Conditions: Tension-Type Headache
Sponsor: Tonix Pharmaceuticals, Inc.
Start date: 2015-06-01; Completion date: 2016-02-01
Enrollment: 165 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, multicenter, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of a single dose of TNX-201 (140 mg) for the treatment of a single qualifying Tension-Type-Headache (TTH).

Detailed description:
The study will be conducted in 4 periods (the Screening Period, the Run-In Period, the Double-Blind Treatment Period and the Follow-up Period) and 4 visits (the Screening Visit, Enrollment Visit, Randomization Visit and End-of-Study Visit).

Screening Period- Eligible subjects who provide written informed consent to participate will have study assessments performed at the Screening.

Run-In Period- The Run-In Period will last for at least 28 days. During the Run-In period, subjects will be assessed for frequency of headache, study compliance and to ensure they meet all required study criteria for randomization.

Double-Blind Treatment Period- The Double-Blind Treatment Period (Treatment Period) will last up to 4 weeks or until a qualifying headache episode has occurred and been treated using the study drug, whichever occurs first.

Follow-up Period- All subjects will return to the investigational site for this visit, regardless of whether they have treated a qualifying TTH with study medication. Subjects who have not treated a qualifying TTH with study drug during the Treatment Period will be asked to return study materials and undergo safety evaluations at the End-of-Study Visit and will be discharged from the study. Subjects who have treated a qualifying TTH with study drug during the Treatment Period will ingest a 140 mg dose of open-label TNX-201 at this visit and undergo urine and blood sample collection for 3 hours post-dose to characterize each subject's genetic metabolism and PK profile.

Arms: arm 1: 4 X 35 mg capsules to be taken when qualifying tension-type headache occurs arm 2: 4 X placebo capsules to be taken when qualifying tension-type headache occurs
Interventions: intervention 1: TNX-201 intervention 2: Placebo
Intervention descriptions: intervention 1: TNX-201 capsule intervention 2: Placebo capsule

Protocol documents:
Clinical trial NCT02424357
Conditions: Suture Strabismus Surgery
Keywords: Adjustable strabismus surgery suture contamination 5%povidone iodine
Sponsor: University of Miami
Start date: 2015-07-01; Completion date: 2016-02-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
1. To establish the culture positivity rate in adjustable suture strabismus surgery
2. To identify bacterial species and antibiotic susceptibility patterns of microorganisms cultured from suture material
3. To compare suture contamination rates with techniques to reduce the suture contamination rate

Detailed description:
Patients will be randomized into 1 of 2 groups: those who received 1 drop of 5% povidone-iodine instilled directly over the sliding noose at surgery completion (group 1) and those who did not receive povidone-iodine at the end of the surgery (group 2).

Institutional standard surgical preparation will be performed in all patients with 5% povidone-iodine solution on the periocular skin and eyelid margins, followed by instillation of 1 drop of 5% povidone-iodine into the conjunctival cul-de-sac.

All operations will be performed using a sliding noose technique with a polyglactin 6-0 suture (Vicryl, Ethicon Inc). If a patient undergoes surgery on more than 1 muscle in the same eye, a 1-cm section of suture proximal to the knot will be collected from the nonadjustable suture as a control. The control suture will be placed in a tube with 2 mL of trypticase soy broth and agitated for 1 minute. At the end of surgery, patients in group 1 will receive a drop of povidone-iodine. A strip of neomycin sulfate, polymyxin B sulfate, and dexamethasone ophthalmic ointment will be then applied into the lower conjunctival fornix to patients in both groups.

Arms: arm 1: patient received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion arm 2: patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
Interventions: intervention 1: 5%povidone iodine ophthalmic solution intervention 2: routine post-operative ophthalmic ointment
Intervention descriptions: intervention 1: one drop of 5% povidone iodine instilled into the conjunctival fornix. intervention 2: patient received a routine antibiotic/steroid ointment to operated eye at surgery completion

Protocol documents:
Clinical trial NCT02431754
Conditions: Benign Prostatic Hyperplasia
Sponsor: Eli Lilly and Company
Start date: 2015-04-01; Completion date: 2016-02-01
Enrollment: 171 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The main purpose of this study is to evaluate the safety and efficacy of the study drug known as tadalafil in participants with benign prostatic hyperplasia who are being treated with an alpha1 blocker. This study has two treatment periods. Participants will receive tadalafil or placebo in each treatment period.

Detailed description:

Arms: arm 1: 5 milligrams (mg) tadalafil administered once daily orally for 8 weeks in one of two treatment periods.

0.2 mg tamulosin once daily or 4 mg silodosin twice daily.

Participants will remain on stable dose of alpha1 blocker through both treatment periods. arm 2: Placebo administered once daily orally for 8 weeks in one of two treatment periods.

0.2 mg tamulosin once daily or 4 mg silodosin twice daily.

Participants will remain on stable dose of alpha1 blocker through both treatment periods.
Interventions: intervention 1: Tadalafil intervention 2: Placebo intervention 3: Alpha1 Blocker
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally

Protocol documents:
Clinical trial NCT02445911
Conditions: Diabetes Mellitus, Type 2
Sponsor: Kaneq Bioscience Limited
Start date: 2015-06-01; Completion date: 2016-02-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will consist of multiple ascending oral doses in up to 3 groups, for 29 days.

Detailed description:

Arms: arm 1: Single loading dose on day 1, followed by single doses on days 8, 15, 22, 29 arm 2: Single loading dose on day 1, followed by a daily dose for 28 days arm 3: Single loading dose on day 1 or days 1-2, followed by a daily dose for 28 days arm 4: Multiple ascending doses matching KQ-791 dose
Interventions: intervention 1: KQ-791 intervention 2: Placebo
Intervention descriptions: intervention 1: Capsules administered orally intervention 2: Capsules administered orally

Protocol documents: