ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02119819
Conditions: Diabetes Mellitus, Type 2
Keywords: Weight loss
Sponsor: OPKO Health, Inc.
Start date: 2014-04-01; Completion date: 2015-10-01
Enrollment: 420 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to compare the safety and effectiveness of the study drug known as LY2944876 to exenatide extended-release and placebo in participants with type 2 diabetes mellitus. All drugs will be given by an injection under the skin. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Participants' involvement in the study is expected to last about 30 weeks.

Detailed description:
The study will include a 12 week blinded treatment period, where neither the participant nor the investigator will know to which treatment each individual is assigned. Thereafter follows a 12 week period where participants and the investigator will know which treatment they are assigned to. Participants' on LY2944876 and on exenatide extended-release continue treatment in this period, those who received placebo will be followed without treatment.

Arms: arm 1: 10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.

Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. arm 2: 15 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. arm 3: 30 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. arm 4: 50 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. arm 5: 2 mg exenatide extended-release given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. arm 6: Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.

Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
Interventions: intervention 1: LY2944876 intervention 2: Exenatide extended-release intervention 3: Placebo intervention 4: Metformin
Intervention descriptions: intervention 1: Administered SC intervention 2: Administered SC intervention 3: Administered SC intervention 4: Oral

Protocol documents:
Clinical trial NCT02152371
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2014-05-01; Completion date: 2015-10-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to evaluate the use of the study drug known as dulaglutide in participants with type II diabetes who are taking once-daily insulin glargine. The study will last about 31 weeks for each participant.

Detailed description:

Arms: arm 1: 1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses. arm 2: Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Interventions: intervention 1: Dulaglutide intervention 2: Placebo intervention 3: Insulin Glargine intervention 4: Metformin
Intervention descriptions: intervention 1: Administered SQ intervention 2: Administered SQ intervention 3: Administered SQ intervention 4: Administered orally

Protocol documents:
Clinical trial NCT02167139
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, Adalimumab
Sponsor: Samsung Bioepis Co., Ltd.
Start date: 2014-05-01; Completion date: 2015-10-01
Enrollment: 544 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomised, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of SB5 compared to Humira® in subjects with moderate to severe RA despite MTX therapy.

Detailed description:
Investigational product: SB5 40 mg (0.8 mL of 50 mg/mL) Indication studied: Rheumatoid arthritis

Arms: arm 1: SB5 40 mg every other week via subcutaneous injection arm 2: Humira 40 mg every other week via subcutaneous injection
Interventions: intervention 1: Humira (adalimumab) intervention 2: SB5 (proposed biosimilar to adalimumab)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02184156
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis osteoarthritis of the knee
Sponsor: Ampio Pharmaceuticals. Inc.
Start date: 2014-06-01; Completion date: 2015-10-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 1 will evaluate the safety of 3 intra-articular injections of Ampion™ administered 2 weeks apart to adults with osteoarthritis of the knee.

In the absence of serious drug-related Adverse Events (AEs) of unanticipated drug-related AEs, enrollment will be initiated in Phase 2 of the study.

Phase 2 will evaluate the efficacy of 3 intra-articular injections, given 2 weeks apart, of Ampion™ in Adults with pain due to osteoarthritis of the knee.

Detailed description:
Phase 1: An open-label study to evaluate the safety of 3 intra-articular injections of of Ampion™ 4 mL at Baseline (Day 0) and Weeks 2 and 4 to adults with osteoarthritis (OA) knee pain. Enrollment will be initiated in Phase 2 if no serious drug-related adverse events or unanticipated drug-related adverse events are observed.

Phase 2: A randomized, placebo-controlled, double-blind, study to evaluate the safety and efficacy of 3 intra-articular (IA) injections of Ampion™ 4 mL at Baseline (Day 0) and Weeks 2 and 4 in adults with OA knee pain.

Study Objectives

Phase 1:

To evaluate the safety of Ampion™ 4 mL administered as 3 intra-articular injections, two weeks apart, in subjects suffering from OA of the knee from Baseline to Week 20.

Phase 2:

The primary study objective is to evaluate the safety and efficacy of Ampion™ 4 mL versus placebo injection from Baseline to Week 20, when administered as three intra-articular (IA) injections (at Baseline (Day 0) and Weeks 2 and 4), in improving knee pain in subjects suffering from OA of the knee.

Arms: arm 1: 4 mL injection of Ampion arm 2: 4 mL injection of placebo
Interventions: intervention 1: 4 mL injection of Ampion intervention 2: 4 mL injection of Placebo
Intervention descriptions: intervention 1: 4 mL injection of Ampion intervention 2: None

Protocol documents:
Clinical trial NCT02187809
Conditions: Dravet Syndrome
Sponsor: H. Lundbeck A/S
Start date: 2015-03-01; Completion date: 2015-10-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To investigate the long-term safety and tolerability of clobazam when administered for 1 year as adjunctive therapy in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.

Detailed description:

Arms: arm 1: A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally
Interventions: intervention 1: Clobazam
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02189915
Conditions: Depression Dual Diagnosis Substance Use
Sponsor: Perry Renshaw
Start date: 2012-01-01; Completion date: 2015-10-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study Purposes and Objectives:

The objectives should be stated in such a way that the reader can determine the appropriateness of the study design. If appropriate, state the specific hypotheses being tested and/or study aims. Use lay language.

Methamphetamine use is of great concern in the state of Utah because it's the primary drug of threat in the state, and is the primary drug of choice among females between the ages of 18 and 24. The primary hypothesis of the study is that eight weeks of oral creatine supplementation will result in improvements in depression rating scores in female MA users. Secondary hypotheses include the following: 1) creatine supplementation will result in a decrease in the number of positive MA screens; 2) NAA and Cr concentrations will increase after eight weeks of oral creatine supplementation; and 3) PCr/β-NTP levels in the frontal lobe using 31P MRS will increase after eight weeks of creatine monohydrate oral supplementation.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Creatine monohydrate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02197273
Conditions: Osteoarthritis, Knee Osteoarthritis, Hip Osteoarthritis, Shoulder
Keywords: Total knee arthroplasty Total shoulder arthroplasty Total hip arthroplasty Total joint arthroplasty Hip replacement Knee replacement Shoulder replacement
Sponsor: OhioHealth
Start date: 2014-07-01; Completion date: 2015-10-01
Enrollment: 211 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total joint arthroplasty, as compared to standard of care analgesia.

Detailed description:
Liposomal bupivacaine (Exparel®) is a local anesthetic made up of liposomal encapsulated bupivacaine. It is designed to be injected at the time of surgery into the local soft tissues. Because of its unique liposomal delivery system, Liposomal bupivacaine (Exparel®) has been shown to provide up to 96 hours of pain relief following surgeries. This makes it an attractive option in total joint arthroplasty patients. Combined with the proven efficacy of regional anesthesia, intraoperative liposomal bupivacaine (Exparel®) may provide extended pain relief following total joint arthroplasty. This has the potential to avoid the need for opioid medications. With better pain control, medication side effects can be avoided and patient's length of stay in the hospital can be shortened.

Arms: arm 1: Total Hip Arthroplasty (THA):

All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine

Injection into capsular tissue after placement of the acetabular component:

0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline

Total Knee Arthroplasty (TKA):

All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine All patients will receive an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc

Injection into posterior capsule of the knee:

0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline

Total Shoulder Arthroplasty (TSA):

All patients will receive a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days. arm 2: THA:

Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue

TKA:

Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue

TSA:

All patients will receive a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.

Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle
Interventions: intervention 1: Liposomal bupivacaine intervention 2: Standard of care analgesia
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02201420
Conditions: Kaposi's Sarcoma
Sponsor: Navidea Biopharmaceuticals
Start date: 2014-09-01; Completion date: 2015-10-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study (NAV3-12) is to determine the dissemination and localization of Tc 99m tilmanocept by SPECT and SPECT/CT imaging in subjects with confirmed cutaneous KS. This is a single center, open-label, within-subject study.

Detailed description:

Arms: arm 1: Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.
Interventions: intervention 1: Tc 99m tilmanocept
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02232425
Conditions: Premature Ejaculation
Sponsor: Ixchelsis Limited
Start date: 2014-09-01; Completion date: 2015-10-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effectiveness of IX-01 in men with lifelong premature ejaculation.

Detailed description:

Arms: arm 1: Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity arm 2: Two to four capsules administered orally, 1-6 hours prior to sexual activity
Interventions: intervention 1: IX-01 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02253173
Conditions: Vulvovaginal Atrophy Menopause Dyspareunia Painful Intercourse
Keywords: VVA Painful Sex Postmenopausal
Sponsor: TherapeuticsMD
Start date: 2014-09-01; Completion date: 2015-10-01
Enrollment: 764 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and efficacy of a new formulation of vaginal estradiol for the treatment of symptoms of vulvar and vaginal atrophy in postmenopausal women.

Detailed description:

Arms: arm 1: Estradiol 4mcg Vaginal Softgel Capsule arm 2: Estradiol 10mcg Vaginal Softgel Capsule arm 3: Estradiol 25mcg Vaginal Softgel Capsule arm 4: Placebo Vaginal Softgel Capsule
Interventions: intervention 1: Estradiol intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02254551
Conditions: Multiple Myeloma
Keywords: relapsed multiple myeloma refractory multiple myeloma LDE225 Sonidegib bortezomib smoothened (SMO) inhibitors Velcade
Sponsor: SCRI Development Innovations, LLC
Start date: 2015-01-01; Completion date: 2015-10-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to determine whether the combination of LDE225 (sonidegib) plus bortezomib is safe and effective in the treatment of relapsed or relapsed/refractory multiple myeloma.

Detailed description:
Although multiple myeloma (MM) is considered fatal, survival has dramatically improved with the introduction of more effective treatment options. Despite these advances, all patients eventually relapse and MM is generally considered incurable. LDE225 (Sonidegib) is an oral, investigational smoothened (SMO) inhibitor that has shown anti-tumor activity in certain cancers. Bortezomib is a highly active drug for the treatment of MM and has produced response rates in relapsed and/or refractory patients. This study will investigate the tolerability and feasibility of combining LDE225 with bortezomib in patients with bortezomib-sensitive relapsed or relapsed/refractory MM.

Arms: arm 1: Lead-In Portion: The lead-in portion of this study will investigate the safety and tolerability, and determine the MTD of LDE225, in combination with bortezomib in this patient population.

Expansion Portion: Eligible patients will receive LDE225 orally once daily for 21 days with the dose-level determined in the lead-in portion of the study. Eligible patients will also receive a standard regimen of bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.

Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity.
Interventions: intervention 1: LDE225 intervention 2: Bortezomib
Intervention descriptions: intervention 1: Lead-In: LDE225 will be administered orally at three dose levels starting at 400mg. If acceptable tolerability is demonstrated, escalations may continue up to 800 mg. LDE225 will be administered orally as a single daily dose for 21 days in combination with a fixed dose of bortezomib to be given on Days 1, 4, 8, 11 of each 21 day cycle.

Dose Expansion: LDE225 will be given as a single oral daily dose for 21 days at the MTD determined in the lead-in phase.

Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity. intervention 2: In both the lead-in and dose expansion portions of the study, bortezomib, 1.3 mg/m2, will be administered by subcutaneous injection (SQ) on Days 1, 4, 8, 11 of each 21 day cycle.

Protocol documents:
Clinical trial NCT02310568
Conditions: Generalized Anxiety Disorder
Keywords: PF 06372865 generalized anxiety disorder outpatient safety efficacy suboptimal response
Sponsor: Pfizer
Start date: 2014-11-01; Completion date: 2015-10-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to evaluate whether PF-06372865 is safe and effective in the treatment of sub-optimally controlled symptoms of generalized anxiety disorder during two 4-week treatment periods using a Sequential Parallel Comparison Design (SPCD). The study will use the Hamilton Anxiety Rating Scale (HAM-A) to measure change in symptoms from baseline for two doses of PF-06372865 compared to placebo.

Detailed description:

Arms: arm 1: PF 06372865 2.5 mg tablet 2 times daily for 4 weeks (Stage 1), followed by placebo 2 times daily for 4 weeks (Stage 2). arm 2: PF 06372865 2.5 mg tablet 2 times daily for one week, then PF 06372865 7.5 mg tablet 2 times daily for 3 weeks (Stage 1), followed by placebo (2 times daily) for 4 weeks (Stage 2). arm 3: Placebo 2 times daily for 4 weeks (Stage 1), followed by PF 06372865 2.5 mg tablet 2 times daily for 4 weeks arm 4: Placebo 2 times daily for 4 weeks (Stage 1), followed by PF 06372865 2.5 mg tablet 2 times daily for one week, then PF 06372865 7.5 mg tablet 2 times daily for 3 weeks (Stage 2). arm 5: Placebo 2 times daily for 4 weeks (Stage 1) followed by Placebo 2 times daily for 4 weeks (Stage 2).
Interventions: intervention 1: PF-06372865.
Intervention descriptions: intervention 1: Blinded PF 06372865 and matching placebo will be provided as tablets for oral administration.

Protocol documents:
Clinical trial NCT02322216
Conditions: Allergic Conjunctivitis
Keywords: Allergies Ocular
Sponsor: Alcon Research
Start date: 2014-12-01; Completion date: 2015-10-01
Enrollment: 383 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate olopatadine 0.2% QD (once per day) compared to olopatadine 0.1% BID (twice per day) in the treatment of ocular itching associated with allergic conjunctivitis.

Detailed description:

Arms: arm 1: Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% vehicle in the evening, 1 drop in each eye for 14 days arm 2: Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
Interventions: intervention 1: Olopatadine Hydrochloride Ophthalmic Solution 0.2% intervention 2: Olopatadine Hydrochloride Ophthalmic Solution 0.1% intervention 3: Olopatadine 0.2% Vehicle
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Inactive ingredients used as placebo comparator

Protocol documents:
Clinical trial NCT02391038
Conditions: Advanced Gastrointestinal Carcinoma Gastroesophageal Junction Adenocarcinoma Recurrent Gastric Adenocarcinoma Recurrent Gastroesophageal Junction Adenocarcinoma Metastatic Gastric Adenocarcinoma Metastatic Gastroesophageal Junction Adenocarcinoma Recurrent Gastrointestinal Carcinoma
Keywords: MLN0264 Advanced gastrointestinal carcinoma
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2014-12-01; Completion date: 2015-10-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of MLN0264 in previously treated Asian participants with Advanced Gastrointestinal (GI) Carcinoma (Phase 1) or Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma (Phase 2) Expressing Guanylyl Cyclase C (GCC).

Detailed description:
The drug being tested in this study is called MLN0264. This drug is being evaluated to check the effects on previously treated Asian individuals with Advanced GI Carcinoma (Phase 1) or Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma (Phase 2). The study will enroll approximately 95 participants.

In Phase 1, approximately 14 Asian participants with GI malignancies will be enrolled in 3 planned dose cohorts according to the traditional 3 + 3 dose escalation scheme. The starting dose will be 1.2 mg/kg of MLN0264 administered IV on Day 1 of 3-week cycles for up to 1 year or until disease progression or unacceptable toxicity occurs. Dose escalation will take place until Phase 2 recommended dose is determined.

In Phase 2, eligible Asian participants with advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction will be enrolled. Participants must have failed at least 2 lines of prior anticancer therapy for advanced or metastatic disease. Disease recurrence within 6 months of the last dose of post-surgical adjuvant chemotherapy counts as 1 line of prior anticancer therapy for advanced disease.

This multi-center trial will be conducted in Japan, Korea and Taiwan. The overall time to participate in this study is up to 3 years.

Arms: arm 1: Phase 1: MLN0264 1.2 milligram per kilogram (mg/kg) starting dose, Intravenous (IV), on Day 1 of 3 week cycles, for up to 1 year or until disease progression or unacceptable toxicity. Dosage of MLN0264 will be increased to 1.5 mg/kg then 1.8 mg/kg using a 3 + 3 dose escalation design to determine a maximum tolerated dose (MTD) and/or recommended Phase 2 Dose (RP2D).

Phase 2: MLN0264, IV, on Day 1 of 3 week cycles, for up to 1 year or until disease progression or unacceptable toxicity. Dosage for this phase will be determined from results of Phase 1 MTD/RP2D.
Interventions: intervention 1: MLN0264
Intervention descriptions: intervention 1: MLN0264 IV.

Protocol documents: