ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01159574
Conditions: Multiple Myeloma
Sponsor: Weill Medical College of Cornell University
Start date: 2010-08-01; Completion date: 2015-05-05
Enrollment: 121 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is intended to investigate the combination of the combination of dexamethasone (Decadron®), Clarithromycin (Biaxin®), and pomalidomide (CC-4047®) \[ClaPd\] in multiple myeloma patients who have relapsed or refractory disease who have failed prior treatment with lenalidomide when used alone or in combination with corticosteroids. Primary endpoint will be response rate to treatment. Secondary endpoints will include toxicity of the combination, time to maximum response, and time to disease progression

Detailed description:
This phase II study is a treatment program for patients with relapsed or refractory multiple myeloma who have had prior treatment with lenalidomide. Up to 54 patients will be enrolled. Patients who sign informed consent form and fulfill all eligibility criteria will be enrolled.

ClaPd therapy:

Dexamethasone (40mg ) on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.

Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle.

Serial clinic visits and laboratory measurements will be performed to monitor for treatment response. Those patients who demonstrate progression of disease at any point during ClaPd therapy will be taken off study.

At the end of every cycle (which may coincide with day 1 of the new cycle), response and toxicity will be evaluated. During cycle 1, patients will have labwork done weekly (CBC with differential and blood electrolytes). All patients will remain on study until disease progression or side effects become excessive. Patients who achieve a stable plateau may be taken off study if eligible to proceed to high dose chemotherapy and autologous stem cell transplantation.

Arms: arm 1: ClaPd therapy:

Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.

Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.
Interventions: intervention 1: dexamethasone intervention 2: clarithromycin intervention 3: Pomalidomide
Intervention descriptions: intervention 1: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle intervention 2: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle intervention 3: orally 4mg daily for days 1-21 of each 28 day cycle

Protocol documents:
Clinical trial NCT02054897
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2014-02-03; Completion date: 2015-05-08
Enrollment: 388 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes. (SUSTAIN™ 1-Monotherapy).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: semaglutide intervention 2: placebo
Intervention descriptions: intervention 1: Once weekly, administrated subcutaneously (s.c. under the skin) intervention 2: Once weekly, administrated subcutaneously (s.c. under the skin)

Protocol documents:
Clinical trial NCT01673854
Conditions: Melanoma
Sponsor: Bristol-Myers Squibb
Start date: 2012-09-13; Completion date: 2015-05-12
Enrollment: 70 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety profile of vemurafenib, 960 mg, administered for 6 weeks, followed by ipilimumab monotherapy in patients with BRAF V600 mutated advanced/metastatic melanoma.

Detailed description:

Arms: arm 1: Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity.
Interventions: intervention 1: Ipilimumab intervention 2: Vemurafenib
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01768520
Conditions: Knee Osteoarthritis
Sponsor: Hanlim Pharm. Co., Ltd.
Start date: 2012-07-02; Completion date: 2015-05-13
Enrollment: 338 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical trial is planned to prove Entelon tab. arm is not inferior to Celebrex cap. arm in terms of the efficacy and safety through the change of K-WOMAC's total score sum in patients with osteoarthritis of knee.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks intervention 2: Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks intervention 3: Placebo
Intervention descriptions: intervention 1: 1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex
2. evening : 1 tab. of active Entelon 150mg intervention 2: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex
2. evening : 1 tab. of placebo Entelon 150mg intervention 3: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex
2. evening : 1 tab. of placebo Entelon 150mg

Protocol documents:
Clinical trial NCT01796301
Conditions: Postmenopausal Osteoporosis
Keywords: Postmenopausal Osteoporosis
Sponsor: Amgen
Start date: 2013-01-31; Completion date: 2015-05-14
Enrollment: 436 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy.

Detailed description:

Arms: arm 1: Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months. arm 2: Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
Interventions: intervention 1: Romozosumab intervention 2: Teriparatide
Intervention descriptions: intervention 1: Administered by subcutaneous injection once a month. intervention 2: Administered by subcutaneous injection once a day.

Protocol documents:
Clinical trial NCT02130622
Conditions: Diabetic Gastroparesis
Keywords: Diabetic Gastroparesis Promethazine
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2014-07-01; Completion date: 2015-05-14
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Adult diabetic patients (ages 18-65) with gastric emptying scintigraphy-confirmed delayed gastric emptying will be recruited to participate in the study. Using double-blinded methodology, study participants will be randomly assigned to one of two treatment arms: promethazine 12.5 mg three times daily for 28 days or placebo three times daily for 28 days. The primary outcome will be the change in gastroparesis symptom severity, as measured by the Gastroparesis Cardinal Symptom Index (GCSI) at four weeks compared to baseline. Participants will be seen for a clinic evaluation at weeks 0, 2 and 4, during which symptom scores, adverse events and treatment compliance will be assessed. It is hypothesized promethazine treatment will be superior to placebo in improving symptoms of gastroparesis.

Detailed description:

Arms: arm 1: Promethazine 12.5 mg P.O. t.i.d. for 4 weeks arm 2: Placebo P.O. t.i.d. for 4 weeks
Interventions: intervention 1: Promethazine intervention 2: Sugar pill
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01598090
Conditions: Hepatitis C Virus
Sponsor: Bristol-Myers Squibb
Start date: 2012-06-14; Completion date: 2015-05-15
Enrollment: 881 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Peginterferon Lambda-1a intervention 2: Peginterferon Alfa-2a intervention 3: Ribavirin intervention 4: Telaprevir
Intervention descriptions: intervention 1: Syringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response intervention 2: Syringes, SC, 180μg, Once weekly, 24 or 48 weeks depending on response intervention 3: Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response intervention 4: Tablets, Oral, 750 mg, three times a day, 12 weeks only

Protocol documents:
Clinical trial NCT01465802
Conditions: Non Small Cell Lung Cancer (NSCLC)
Keywords: non-small cell lung cancer advanced previously treated
Sponsor: Pfizer
Start date: 2011-12-26; Completion date: 2015-05-18
Enrollment: 236 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
To assess the impact of prophylactic treatment on the incidence of adverse events in advanced NSCLC patients (post chemotherapy) treated with dacomitinib daily as a single agent. To assess the impact of an interrupted dacomitinib dosing schedule in Cycle 1 on the incidence of adverse events in first-line advanced NSCLC patients with an EGFR mutation (HER-1 mutation, HER-2 mutation or HER-2 amplification).

Detailed description:

Arms: arm 1: Arm A: Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent Doxycycline placebo orally BID for 4 weeks Arm B: Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent Doxycycline 100 mg orally BID for 4 weeks arm 2: Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent Topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks VSL#3 probiotic 4 capsules orally daily or 1 sachet orally daily for up to 5 weeks (starting between Day minus 7 to Day minus 4 and continuing through Day 28) arm 3: Cohort III is an interrupted dosing schedule of dacomitinib in the first cycle only
Interventions: intervention 1: Dacomitinib intervention 2: Dacomitinib intervention 3: Doxycycline intervention 4: Probiotic intervention 5: Alclometasone cream
Intervention descriptions: intervention 1: Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent intervention 2: Dacomitinib 45 mg orally daily on a continuous schedule for the first 10 days in Cycle 1, followed by 4 days off treatment, followed by continuous daily dosing until disease progression, toxicity, death or withdrawal of consent intervention 3: Doxycycline or Doxycycline placebo BID for 4 weeks intervention 4: VSL#3 probiotic 4 capsules orally daily or 1 sachet orally daily for up to 5 weeks (starting between Day minus 7 to Day minus 4 and continuing through Day 28) intervention 5: Topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks

Protocol documents:
Clinical trial NCT02093923
Conditions: Hereditary Angioedema (HAE)
Keywords: HAE
Sponsor: Shire
Start date: 2014-05-14; Completion date: 2015-05-18
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of multiple subcutaneous administrations of DX-2930 across a range of doses in HAE participants.

Detailed description:

Arms: arm 1: Participants will receive 30 milligram (mg) dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. arm 2: Participants will receive 100 mg dose of DX-2930 SC injection once and followed by the second dose after 2 week into the upper arm. arm 3: Participants will receive 300 mg dose of DX-2930 SC injection once and followed by the second dose after 2 week into the upper arm. arm 4: Participants will receive 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. arm 5: Participants will receive placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 SC injection once and followed by the second dose after 2 week into the upper arm.
Interventions: intervention 1: DX-2930 intervention 2: Placebo
Intervention descriptions: intervention 1: Participants will receive SC injection of DX-2930 (a recombinant, Chinese hamster ovary \[CHO\] cell expressed, fully human immunoglobulin IgG1, kappa light chain, monoclonal antibody) once and followed by the second dose after 2 week into the upper arm. intervention 2: Participants will receive matching placebo subcutaneously.

Protocol documents:
Clinical trial NCT01544920
Conditions: Hepatitis C, Chronic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-05-30; Completion date: 2015-05-19
Enrollment: 737 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to compare the efficacy of two boceprevir (BOC)-containing therapeutic regimens in the treatment of naïve participants with chronic hepatitis C virus (HCV) genotype 1 who have the IL28B CC allele.

The regimens differ in the treatment for participants who achieve undetectable HCV ribonucleic acid (RNA) at the end of the peginterferon alfa-2a (peg-IFN) plus ribavirin (RBV) 4 week lead-in. Participants receive either peg-IFN + RBV (Arm 1) or BOC + peg-IFN + RBV (Arm 2). The hypothesis is that Arm 2 is noninferior to Arm 1 in the proportion of participants with undetectable HCV RNA at Follow-Up (FU) Week 24.

Detailed description:

Arms: arm 1: Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) \[Arm 1a\]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV \[Arm 1b\]. arm 2: Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) \[Arm 2a\]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV \[Arm 2b\].
Interventions: intervention 1: peg-Interferon alfa-2a intervention 2: Ribavirin intervention 3: Boceprevir
Intervention descriptions: intervention 1: peg-IFN (180 ug) was taken once weekly via subcutaneous injection. intervention 2: RBV 200 mg tablets taken by mouth at a total daily dose of 1,000 mg (body weight \<75 kilograms \[kg\]) or 1,200 mg (body weight ≥75 kg) with total daily dose divided into 2 dosings. intervention 3: Four 200 mg BOC capsules taken three times a day by mouth for a total daily dose of 2,400 mg.

Protocol documents:
Clinical trial NCT01362608
Conditions: Gouty Arthritis
Keywords: Gout Inflammatory gout acute gout
Sponsor: Novartis Pharmaceuticals
Start date: 2011-06-20; Completion date: 2015-05-19
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 \& CACZ885H2357 by demonstrating in patients with frequent flares of gout for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c. given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares compared to triamcinolone acetonide 40 mg i.m.

Detailed description:

Arms: arm 1: ACZ885H arm 2: ACZ885H
Interventions: intervention 1: Canakinumab, ACZ885 intervention 2: Triamcinolone acetonide
Intervention descriptions: intervention 1: Canakinumab and placebo matching to triamcinolone acetonide intervention 2: Triamcinolone acetonide 40 mg and placebo matching to canakinumab

Protocol documents:
Clinical trial NCT02105662
Conditions: Chronic Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-06-03; Completion date: 2015-05-22
Enrollment: 218 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the efficacy and safety of grazoprevir (MK-5172) 100 mg in combination with elbasvir (MK-8742) 50 mg in the treatment of chronic hepatitis C virus (HCV) in participants who are co-infected with human immunodeficiency virus (HIV). The primary hypothesis is that the percentage of participants who receive grazoprevir + elbasvir and achieve Sustained Virologic Response after 12 weeks of therapy (SVR12) will be greater than 70%.

Detailed description:

Arms: arm 1: Participants receive a fixed-dose combination (FDC) of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and are followed-up for 24 weeks.
Interventions: intervention 1: Grazoprevir 100 mg/Elbasvir 50 mg fixed-dose combination tablets
Intervention descriptions: intervention 1: MK-5172A FDC tablet: MK-5172 (100 mg)/MK-8742 (50 mg)

Protocol documents:
Clinical trial NCT02178098
Conditions: Hypercholesterolemia Hypertension
Keywords: LDL Cholesterol
Sponsor: Esperion Therapeutics, Inc.
Start date: 2014-06-16; Completion date: 2015-05-22
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 2 study will assess the efficacy and safety of ETC-1002 monotherapy versus placebo in participants with hypercholesterolemia and hypertension.

Detailed description:

Arms: arm 1: ETC-1002 180 mg/day arm 2: Placebo control
Interventions: intervention 1: ETC-1002 intervention 2: Placebo
Intervention descriptions: intervention 1: ETC-1002 capsules taken once daily intervention 2: Placebo capsules taken once daily

Protocol documents:
Clinical trial NCT01794780
Conditions: COPD
Keywords: COPD Chronic obstructive pulmonary disease (COPD), Chronic obstructive lung disease (COLD), Chronic obstructive airway disease (COAD), Cronchitis, Emphysema
Sponsor: Novartis Pharmaceuticals
Start date: 2013-02-05; Completion date: 2015-05-25
Enrollment: 2229 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multi-center study is designed to describe natural history of disease, treatment and health care products in physician-diagnosed COPD patients who require adding daily maintenance therapy in real world.

The study planned to enroll 550 patients in Indacaterol group and 9450 patients in non- Indacaterol group, a total of 10,000 patients. Enrollment was stopped at 2253 patients due to low recruitment in indacaterol group. Finally a total of 2229 patients were analyzed in full analysis set.

A total of 2253 patients entered into the database, of which 24 patients were exclude during the data review meetings, because they did not met the inclusion/exclusion criteria. Hence a total of 2229 patients enrolled successfully.

Detailed description:

Arms: arm 1: LABA: Indacaterol, once a day, 150μg each time arm 2: LAMA: Tiotropium Bromide, once a day, 18 μg arm 3: LABA/ICS: Salmeterol/Fluticasone, twice a day, 50/250 μg, 50/500 μg arm 4: Budesonide/formoterol, twice daily, two suction each time, 160/4.5 μg arm 5: Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg arm 6: Salmeterol / fluticasone Or budesonide / formoterol arm 7: None arm 8: non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"
Interventions: intervention 1: LABA based treatment: indacaterol intervention 2: LAMA based treatment: tiotropium intervention 3: LABA/ICS based treatment: salmeterol/fluticasone intervention 4: LABA/ICS based treatment: budesonide/formoterol intervention 5: theophylline based treatment intervention 6: Other treatment
Intervention descriptions: intervention 1: LABA based treatment: indacaterol intervention 2: LAMA based treatment: tiotropium intervention 3: LABA/ICS based treatment: salmeterol/fluticasone intervention 4: LABA/ICS based treatment: budesonide/formoterol intervention 5: theophylline based treatment intervention 6: non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"

Protocol documents: