ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02586493
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Placebo ELLIPTA inhaler Correct use COPD Ease of use
Sponsor: GlaxoSmithKline
Start date: 2015-10-01; Completion date: 2016-03-15
Enrollment: 278 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The mainstay for treatment involves the use of inhaled medications, including short and/or long-acting bronchodilators along with inhaled corticosteroids. For inhaled medications, the choice of inhalation device is an important consideration because an inadequate technique reduces the effects of inhalation. Therefore, the development of an easy-to-use inhaler that delivers the drug to the lungs effectively, is important. This study will assess the correct use of the ELLIPTA inhaler by subjects with COPD and to assess ease of use of the ELLIPTA inhaler, as rated by those subjects determined to be using the inhaler correctly. Study will be divided into two visits i.e. Screening/Visit 1 (day 1) and Visit 2 (Day 28 +/-2) with a phone call on Day 8+/-2 days of Visit 1 to assess safety. In this multi-center, single-arm, randomised (to receive one of two versions of the ELLIPTA inhaler Ease of Use questionnaires), open-label, placebo study, only subjects who are have never used the ELLIPTA inhaler before and have an established diagnosis of COPD and receiving COPD therapy and are able to demonstrate correct use of the ELLIPTA inhaler at Visit 1 will be considered eligible to participate in this study. Approximately 252 subjects will be screened with an expectation of 208 subjects completing the study while demonstrating correct ELLIPTA inhaler use at visit 2.

ELLIPTA is a registered trademark of the GlaxoSmithKline Group of Companies.

Detailed description:

Arms: arm 1: Subjects will be provided the ELLIPTA inhaler, which is a molded plastic two-sided inhaler that holds two individual blister strips containing either lactose or a blend of lactose and magnesium stearate. Subjects will continue to use regular COPD medications throughout the study as per protocol.
Interventions: intervention 1: Placebo intervention 2: Questionnaire
Intervention descriptions: intervention 1: Subjects will receive 1 inhalation once-daily until visit 2. intervention 2: ELLIPTA Inhaler Ease of Use Questionnaire is a four-point Likert scale. This questionnaire will be filled by investigator (designee) based on responses received from subject. Responses for the questionnaire are Very difficult, Difficult, Easy, Very easy. Subjects will be give either version A or B at Visit 2.

Protocol documents:
Clinical trial NCT01283386
Conditions: Lymphocytic Leukemia, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2011-04-27; Completion date: 2016-03-16
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multi-center, randomized study compared the efficacy and safety of MabThera (rituximab) in combination with either fludarabine and cyclophosphamide or with chlorambucil in participants with previously untreated B-cell chronic lymphocytic leukemia and unfavorable somatic status. Participants were randomized to receive Mabthera (375 mg/m2 intravenously \[IV\] Day 1 of Cycle 1, 500 mg/m2 IV Day 1 Cycles 2-6) with either fludarabine (20 mg/m2 IV or 32 mg/m2 orally Days 1-3) and cyclophosphamide (150 mg/m2 IV or orally Days 1-3) or with chlorambucil (10 mg/m2 orally Days 1-7) for 6 cycles of 28 days. Anticipated time on study treatment was 24 weeks.

Detailed description:

Arms: arm 1: Rituximab, fludarabine, and cyclophosphamide arm 2: Rituximab and chlorambucile
Interventions: intervention 1: Chlorambucil intervention 2: Cyclophosphamide intervention 3: Fludarabine intervention 4: Rituximab
Intervention descriptions: intervention 1: 10 mg/m\^2 orally on Days 1-7 of each 28-day cycle for 6 cycles intervention 2: 150 mg/m\^2 IV or orally on Days 1-3 of each 28-day cycle for 6 cycles intervention 3: 20 mg/m\^2 IV or 32 mg/m2 orally Days 1-3 of each 28-day cycle for 6 cycles intervention 4: 375 mg/m2 IV on Day 1 of Cycle 1; 500 mg/m2 IV on Day 1 of Cycles 2-6 (28-day cycles)

Protocol documents:
Clinical trial NCT01913483
Conditions: Peripheral Endovascular Interventions Bleeding
Sponsor: The Medicines Company
Start date: 2013-09-24; Completion date: 2016-03-16
Enrollment: 732 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to test whether anticoagulation with bivalirudin results in fewer major bleeding complications compared with unfractionated heparin (UFH) in participants undergoing peripheral endovascular interventions (PEI). The secondary objective is to test whether there were potential benefits from bivalirudin therapy on other clinically important events such as death, myocardial infarction (MI), stroke and/or transient ischemic attack (TIA), amputation, unplanned repeat revascularization (URV), and minor bleeding, as well as potential economic benefits that may result from improved clinical outcomes.

Detailed description:

Arms: arm 1: Bivalirudin was administered as an intravenous (IV) bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 milligrams (mg)/kilogram \[kg\]) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/hour (h) (or 1 mg/kg/h for participants with an estimated glomerular filtration rate \[eGFR\] \<30 milliliters/minute \[mL/min\]). arm 2: UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 units (U)/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
Interventions: intervention 1: Bivalirudin intervention 2: Unfractionated Heparin
Intervention descriptions: intervention 1: Bivalirudin is an anticoagulant that binds directly to thrombin in a bivalent and reversible fashion. intervention 2: Unfractionated heparin is an anticoagulant.

Protocol documents:
Clinical trial NCT02075463
Conditions: Anemia
Keywords: recombinant human erythropoietin GSK1278863 hemodialysis anemia Hemoglobin chronic rhEPO hyporesponsiveness chronic kidney disease erythropoiesis stimulating agents pharmacokinetics
Sponsor: GlaxoSmithKline
Start date: 2014-06-01; Completion date: 2016-03-16
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study will evaluate the ability of GSK1278863 to increase the hemoglobin (Hgb) concentration, or maintain it within the target range, and the safety and efficacy of GSK1278863 over 16 weeks of treatment, in hemodialysis-dependent subjects with anemia associated with chronic kidney disease who are chronically hyporesponsive to rhEPO. The data generated will inform dose requirements for any chronic rhEPO hyporesponsive hemodialysis-dependent subjects included in future clinical trials. The study consists of a 4-week rhEPO run-in period, a 16-week GSK1278863 treatment period and a 4-week Follow-up period.

Detailed description:

Arms: arm 1: Subjects will receive a fixed starting dose of 12 milligrams (mg) GSK1278863 once daily (QD) orally for first 4 weeks. From Week 4 the dose of GSK1278863 will be adjusted based on Hgb levels and evaluated every 4 weeks until Week 16. This starting dose may be changed during the study if there is an early indication of either lack of efficacy or the rate of rise in Hgb is too rapid
Interventions: intervention 1: GSK1278863 intervention 2: Placebo
Intervention descriptions: intervention 1: Film coated tablets containing 1 mg, 2 mg, 5 mg or 25 mg of GSK1278863 intervention 2: Matching placebo tablet for GSK1278863

Protocol documents:
Clinical trial NCT01894672
Conditions: Melanoma
Keywords: LGX818 BRAF Inhibitor Stage IV melanoma unresectable stage III melanoma BRAFV600 mutation 13-053
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2013-07-01; Completion date: 2016-03-17
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this phase II study is to find out if an investigational drug called LGX818 can stop the melanoma from growing.

Detailed description:

Arms: arm 1: LGX818 capsules will be administered orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.
Interventions: intervention 1: LGX818
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02224690
Conditions: Epilepsy Lennox-Gastaut Syndrome
Keywords: Cannabidiol CBD Epidiolex GWP42003-P
Sponsor: Jazz Pharmaceuticals
Start date: 2015-04-28; Completion date: 2016-03-18
Enrollment: 171 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy of GWP42003-P as adjunctive treatment in reducing the number of drop seizures when compared with placebo, in participants with Lennox-Gastaut Syndrome (LGS).

Detailed description:
This study was a 1:1 randomized, double-blind, 14-week comparison of 20 milligram \[mg\] per kilogram \[kg\] per day \[mg/kg/day\] of GWP42003-P versus placebo. The treatment period consisted of a 2-week titration period followed by a 12-week maintenance period. The study determined the efficacy, safety and tolerability of GWP42003-P compared with placebo. The dose was recommended by the Data Safety Monitoring Committee (DSMC) after assessment of safety and pharmacokinetic data from Part A of study GWEP1332. The first participants enrolled into this study after the DSMC reviewed the safety data from Part A of study GWEP1332. Following study completion, all participants were invited to continue to receive GWP42003-P in an open label extension (OLE) study (under a separate protocol).

Arms: arm 1: Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period. arm 2: Participants received placebo (0 mg/mL CBD), volume matched to the 20 mg/kg/day dose, administered orally, half in the morning and half in the evening. To maintain the blinded aspect of the study, participants titrated the placebo dose over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
Interventions: intervention 1: GWP42003-P 20 mg/kg/day Dose intervention 2: Placebo
Intervention descriptions: intervention 1: GWP42003-P was presented as an oral solution containing 100 mg/milliliter (mL) cannabidiol (CBD) in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL). intervention 2: Placebo was presented as an oral solution containing 0 mg/mL CBD in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).

Protocol documents:
Clinical trial NCT02533427
Conditions: HCV Infection
Sponsor: Gilead Sciences
Start date: 2015-10-29; Completion date: 2016-03-18
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the effect of sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) fixed-dose combination (FDC) + voxilaprevir on the pharmacokinetics (PK) of a representative hormonal contraceptive medication, norgestimate/ethinyl estradiol (Ortho Tri-Cyclen® Lo (OC)) and will assess the effect of norgestimate/ethinyl estradiol on the PK of SOF/VEL/VOX+VOX.

Detailed description:

Arms: arm 1: Part A: Participants without a documented history of taking norgestimate/ethinyl estradiol for at least one menstrual cycle will receive norgestimate/ethinyl estradiol. Participants with a documented history of taking norgestimate/ethinyl estradiol may enroll directly into Part B of the study.

Part B: Participants will continue taking norgestimate/ethinyl estradiol for the remainder of the study and will receive SOF/VEL/VOX FDC plus VOX.
Interventions: intervention 1: SOF/VEL/VOX intervention 2: VOX intervention 3: Norgestimate/ethinyl estradiol
Intervention descriptions: intervention 1: 400/100/100 mg FDC tablet administered orally once daily intervention 2: 100 mg tablet administered orally once daily intervention 3: Norgestimate 0.180 mg/0.215 mg/0.25 mg/ethinyl estradiol 0.025 mg tablet administered orally once daily according to the package insert

Protocol documents:
Clinical trial NCT02014584
Conditions: Alopecia
Keywords: quality of life safety sexual function male pattern hair loss (MPHL) Androgenic alopecia (AGA) dutasteride satisfaction with hair growth
Sponsor: Stiefel, a GSK Company
Start date: 2014-07-02; Completion date: 2016-03-19
Enrollment: 117 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Treatment of male pattern hair loss (MPHL) or androgenetic alopecia (AGA) with 5α-reductase inhibitor (5-ARIs) has been associated with sexual dysfunction including erectile dysfunction and loss of libido. This will be a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the impact of dutasteride treatment on sexual function as well as subject satisfaction with hair growth and quality of life in men with AGA. This study will consist of a Screening Visit, a 4-week Placebo Run-in Phase, a Treatment Phase of 48 weeks, and a subsequent Follow-up Visit after 4 weeks. The treatment phase will include 24 weeks of double-blind, placebo controlled treatment and 24 weeks of open-label treatment with dutasteride. An extended 6-month Follow-up Visit will be conducted for any individuals with a change in erectile function at the end of treatment.

Detailed description:

Arms: arm 1: Subjects will receive dutasteride 0.5 milligrams (mg) administered orally once daily for 24 Weeks arm 2: Subjects will receive placebo administered orally once daily for 24 Weeks
Interventions: intervention 1: Dutasteride intervention 2: Placebo
Intervention descriptions: intervention 1: Dutasteride will be supplied as soft gelatin capsules, containing 0.5 mg of dutasteride to be administered orally. intervention 2: Dutasteride matching placebo will be supplied as capsules to be administered orally.

Protocol documents:
Clinical trial NCT01677910
Conditions: Carcinoid Syndrome
Sponsor: Lexicon Pharmaceuticals
Start date: 2013-01-08; Completion date: 2016-03-21
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not adequately controlled by current SSA therapy.

Detailed description:

Arms: arm 1: Following a 3 to 4-week run-in period on stable-dose somatostatin analog (SSA) therapy (octreotide or lanreotide) participants were randomized to receive one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks in the double-blind treatment period, followed by a 36 week open-label extension period. arm 2: Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive, one telotristat etiprate 250 mg plus one placebo-matching telotristat etiprate tablet administered 3 times daily for 1 week, followed by two telotristat etiprate (250 mg) tablets administered three times daily for 11 weeks in the double-blind treatment period, followed by a 36 week open-label extension period. arm 3: Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period, followed by a 36 week open-label extension period. arm 4: Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.
Interventions: intervention 1: Telotristat etiprate intervention 2: Placebo-matching telotristat etiprate
Intervention descriptions: intervention 1: Telotristat etiprate tablets. intervention 2: Placebo-matching telotristat etiprate tablets.

Protocol documents:
Clinical trial NCT02482129
Conditions: Acute Anterior Uveitis
Keywords: Acute anterior uveitis LME636
Sponsor: Alcon Research
Start date: 2015-07-17; Completion date: 2016-03-21
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether topical ocular administration of LME636 60 mg/mL is efficacious in resolving the ocular inflammation in the anterior chamber (AC) associated with acute anterior uveitis (AAU).

Detailed description:
Eligible subjects will be randomized to LME636 or Dexamethasone in a 3:1 ratio at the time they present to the trial site with the AAU flare and will enter treatment for 28 full days. Subjects with worsening disease from Visit 2/Day 4 onward or subjects without improvement after 14 days of treatment will be discontinued from treatment, unmasked and treated with a rescue regimen at the discretion of the investigator.

Arms: arm 1: LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4) arm 2: Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
Interventions: intervention 1: LME636 60 mg/mL ophthalmic solution intervention 2: Dexamethasone 0.1% ophthalmic solution intervention 3: LME636 Vehicle
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Inactive ingredients used for masking purposes

Protocol documents:
Clinical trial NCT01887327
Conditions: Jaundice, Neonatal Hyperbilirubinemia, Neonatal
Keywords: G6PD deficiency Antibody (ABO) incompatibility Coombs positive ABO/ rhesus factor (RH) incompatibility Intensive phototherapy in neonates
Sponsor: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Start date: 2013-10-16; Completion date: 2016-03-22
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
It is normal for red blood cells to die, even in newborn babies. The waste from that is called bilirubin. The liver clears bilirubin out of the body.

Some babies are born with illness that makes red blood cells die too fast, so the liver is not strong enough to keep up with it.

The yellowish color in eyes or skin means there is too much bilirubin in the body. It can be dangerous if a baby's bilirubin gets too high.

Special lights are put on jaundiced babies (called phototherapy) to help the liver get rid of bilirubin.

This study tests an experimental drug to see if it can help the liver even more, by safely cutting down the amount of bilirubin the body is making in the first place.

Detailed description:
Participants randomized (1:1:1) to treatment groups will be term or near-term infants with isoimmune hemolytic disease or glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Arms: arm 1: Participants receive placebo and phototherapy arm 2: Participants receive stannsoporfin (3.0 mg/kg) and phototherapy arm 3: Participants receive stannsoporfin (4.5 mg/kg) and phototherapy
Interventions: intervention 1: Phototherapy intervention 2: Stannsoporfin intervention 3: Placebo
Intervention descriptions: intervention 1: Phototherapy starts within 30 minutes before or after injection intervention 2: Stannsoporfin (3.0 or 4.5 mg/kg) administered by intramuscular (IM) injection (a shot in the muscle) intervention 3: Matching placebo administered by IM injection

Protocol documents:
Clinical trial NCT02075008
Conditions: Asthma
Keywords: asthma allergic asthma QGE031 open-label IgE long-term safety
Sponsor: Novartis Pharmaceuticals
Start date: 2014-03-27; Completion date: 2016-03-22
Enrollment: 270 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study planned to assess long-term safety of QGE031 during 12 months treatment in asthma patients who completed study CQGE031B2201.

Detailed description:
This study planned to assess long-term safety and tolerability of QGE031 administered every 4 weeks for an additional 12 months in patients with allergic asthma who previously completed study CQGE031B2201. The study was terminated early due to the efficacy results from an interim analysis of the Phase II study CQGE031B2201.

Arms: arm 1: QGE031 240 mg subcutaneously q4w
Interventions: intervention 1: QGE031
Intervention descriptions: intervention 1: QGE031 120 mg/mL solution for subcutaneous injection

Protocol documents: