ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00719264
Conditions: Carcinoma Adenocarcinoma Renal Cell Nephroid Carcinoma Hypernephroid
Keywords: Renal cell carcinoma Adults Bevacizumab RAD001 Everolimus Interferon Clear Roferon Avastin Nephrectomy newly diagnosed
Sponsor: Novartis Pharmaceuticals
Start date: 2008-11-12; Completion date: 2013-04-15
Enrollment: 365 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To estimate the difference in efficacy and safety of bevacizumab and RAD001 compared to bevacizumab and interferon alfa-2a for first-line treatment of patients with metastatic carcinoma of the kidney.

Detailed description:

Arms: arm 1: Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks arm 2: Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks
Interventions: intervention 1: RAD001(everolimus) intervention 2: interferon alfa-2a intervention 3: bevacizumab
Intervention descriptions: intervention 1: 10 mg qd intervention 2: dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 intervention 3: 10 mg/kg every 2 weeks

Protocol documents:
Clinical trial NCT00975000
Conditions: Chronic Allograft Nephropathy Chronic Kidney Disease Chronic Renal Failure Disordered Mineral Metabolism End Stage Renal Disease Hyperparathyroidism Hypophosphatemia Kidney Disease Kidney Transplantation Post Renal Transplantation
Keywords: Intervention Cinacalcet Sensipar Mimpara hyperparathyroidism calcium osteodystrophy hypercalcemia renal transplant acute rejection kidney transplant failure hypophosphatemia
Sponsor: Amgen
Start date: 2009-12-03; Completion date: 2013-04-16
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Hyperparathyroidism (HPT) is common in people with a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the neck. Patients with HPT can develop bone disease (osteodystrophy). This bone disease can cause bone pain, fractures, and poor formation of red blood cells. Other problems from HPT may include increases in blood levels of calcium (hypercalcemia) and low blood levels of phosphorus (hypophosphatemia). The high calcium levels may cause calcium to deposit in body tissues. Calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft tissue), heart and lung problems or kidney transplant dysfunction (worsening of kidney transplant function). The purpose of this study is to evaluate the effects of cinacalcet (Sensipar/Mimpara) on high calcium levels in the blood in patients with HPT after a kidney transplant.

Detailed description:

Arms: arm 1: Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on intact parthyroid hormone (iPTH) values, corrected total serum calcium values, and safety assessments. arm 2: Participants received placebo orally once daily for 52 weeks.
Interventions: intervention 1: Cinacalcet intervention 2: Placebo
Intervention descriptions: intervention 1: Possible sequential doses are 30, 60, 90, 120, and 180 mg. intervention 2: Administered orally following the same dosing regimen as the experimental arm.

Protocol documents:
Clinical trial NCT01227265
Conditions: Parkinson Disease Idiopathic Parkinson Disease Idiopathic Parkinson's Disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-11-19; Completion date: 2013-04-16
Enrollment: 476 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study of the efficacy and safety of preladenant in adult participants with moderate to severe Parkinson's Disease (PD). While on this study, participants will continue to take their usual, prescribed, stable regimen of levodopa (L-dopa) or L-dopa plus adjunct PD medications and will be randomized to receive 2 mg preladenant, 5 mg preladenant, or placebo, twice daily, for 12 weeks. After that, participants may choose to receive additional treatment with preladenant. The primary hypothesis is that at least the 5 mg twice daily dose of preladenant is superior to placebo as measured by the change from Baseline to Week 12 in the mean "off" time.

Detailed description:

Arms: arm 1: Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later. arm 2: Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later. arm 3: Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
Interventions: intervention 1: Preladenant intervention 2: Placebo
Intervention descriptions: intervention 1: Preladenant 2 mg or 5 mg oral tablet taken twice daily intervention 2: Preladenant-matching placebo oral tablet taken twice daily

Protocol documents:
Clinical trial NCT01564459
Conditions: Diabetic Neuropathy, Painful
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-03-26; Completion date: 2013-04-18
Enrollment: 170 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and effectiveness of MK-6096 in the treatment of painful diabetic neuropathy (PDN) in adults.

Detailed description:

Arms: arm 1: Participants receive MK-6096 10 mg during run-in once daily for 1 week and receive MK-6096 10 mg once daily for 2 weeks during double-blind treatment period. arm 2: Participants receive MK-6096 10 mg during run-in once daily for 1 week and receive placebo once daily for 2 weeks during double-blind treatment period.
Interventions: intervention 1: MK-6096 intervention 2: Placebo
Intervention descriptions: intervention 1: MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days. intervention 2: Matching compressed tablets, taken once daily at bedtime for 14 days.

Protocol documents:
Clinical trial NCT03887130
Conditions: Breast Cancer
Keywords: Breast cancer
Sponsor: Pierre Fabre Medicament
Start date: 2007-03-27; Completion date: 2013-04-18
Enrollment: 152 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this international open-label randomized phase II trial is to evaluate the efficacy and safety of an all-oral combination and two all-intravenous combinations as first-line therapy for HER2-negative mBC patients.

Detailed description:

Arms: arm 1: oral vinorelbine (OV) with capecitabine (CAP) arm 2: gemcitabine (GEM) in combination with paclitaxel (PAC) arm 3: gemcitabine (GEM) in combination with docetaxel (DOC)
Interventions: intervention 1: oral vinorelbine intervention 2: Capecitabine intervention 3: Gemcitabine 1250 mg/m² intervention 4: Gemcitabine 1000 mg/m² intervention 5: Paclitaxel intervention 6: Docetaxel
Intervention descriptions: intervention 1: Oral vinorelbine 60 mg/m² on day 1 \& day 8, for cycle 1, and then 80 mg/m² on day 1 \& day 8, every 3 weeks for subsequent cycles intervention 2: Capecitabine 1000 mg/m² twice a day (2000 mg/m² daily) from day 1 to day 14 intervention 3: Gemcitabine 1250 mg/m² on day 1 \& day 8 intervention 4: Gemcitabine: 1000 mg/m² on day 1 \& 8 intervention 5: Paclitaxel 175 mg/m² on day 1 intervention 6: Docetaxel 75 mg/m² on day 1

Protocol documents:
Clinical trial NCT01277822
Conditions: Hypertension
Keywords: Hypertension Uncontrolled hypertension High blood pressure Uncontrolled high blood pressure Untreated high blood pressure Untreated hypertension Essential hypertension
Sponsor: Organon and Co
Start date: 2011-05-30; Completion date: 2013-04-22
Enrollment: 334 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine whether using losartan and amlodipine together will be non-inferior in lowering blood pressure than amlodipine alone.

Detailed description:

Arms: arm 1: One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks. arm 2: 2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
Interventions: intervention 1: Losartan (+) amlodipine intervention 2: Placebo to match losartan/amlodipine tablets intervention 3: Amlodipine camsylate intervention 4: Placebo to match amlodipine
Intervention descriptions: intervention 1: One tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. intervention 2: One tablet containing placebo, orally, once daily, for 8 weeks. intervention 3: 2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. intervention 4: 2 tablets containing placebo, orally, once daily, for 8 weeks.

Protocol documents:
Clinical trial NCT00171158
Conditions: Philadelphia Chromosome Positive CML
Keywords: Chronic Myelogenous Leukemia CML Philadelphia Chromosome Blast crisis Imatinib mesylate
Sponsor: Novartis Pharmaceuticals
Start date: 1999-07-26; Completion date: 2013-04-22
Enrollment: 260 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This extension II study allowed for further follow-up of the disease under treatment with imatinib mesylate and allow the participants to continue to receive imatinib mesylate.

Detailed description:

Arms: arm 1: Participants initially received STI571 capsules or tablets, orally, initially once daily (400 mg) or (600 mg). The dosage was escalated from 400 mg to 600 mg and from 600 mg to 800 mg, on an individual basis as per the investigator's judgement. Treatment continued until death, or the development of intolerable toxicity, or the participant was considered not to benefit from treatment, whichever came first.
Interventions: intervention 1: imatinib mesylate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00821795
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus, Type 2 insulin therapy
Sponsor: Dennis G. Karounos, M.D.
Start date: 2009-03-11; Completion date: 2013-04-23
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Volunteers are being invited to take part in a research study about insulin therapy of diabetes. They are being invited to take part in this research study because they have diabetes and have an illness requiring hospitalization. If they volunteer to take part in this study, they will be one of about 120 people to do so. The investigators hope to answer the following research questions:

* To show that insulin aspart protamine 70/30 mix taken twice daily is as good as insulin NPH/Reg 70/30 mix taken twice a day for treatment of diabetes after discharge from the hospital.
* To show how safe the two medicines are (insulin aspart 70/30 mix vs. insulin NPH/Reg 70/30 mix) and how well they work for the treatment of diabetes when transitioning from inpatient therapy to outpatient care.

Detailed description:
By doing this study, we hope to learn the optimal way to use insulin therapy to treat individuals during a hospitalization for an illness as well as during the recovery phase of the illness for twenty-four weeks after discharge from the hospital.

Arms: arm 1: transition insulin therapy with NPH/Regular 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness arm 2: transition insulin therapy with Aspart insulin analog 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness
Interventions: intervention 1: NPH/Regular 70/30 mix intervention 2: insulin aspart protamine/insulin aspart 70/30 mix
Intervention descriptions: intervention 1: injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration intervention 2: injectable solution, subcutaneous, 0.3-0.5 units/kg/day divided into twice per day dosage, for 16 weeks

Protocol documents:
Clinical trial NCT01114217
Conditions: Iron Deficiency Anemia
Keywords: Iron deficiency anemia Feraheme Ferumoxytol IDA
Sponsor: AMAG Pharmaceuticals, Inc.
Start date: 2010-07-27; Completion date: 2013-04-23
Enrollment: 634 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the safety and efficacy of ferumoxytol for the episodic treatment of iron deficiency anemia (IDA).

Detailed description:

Arms: arm 1: Participants received ferumoxytol or placebo during AMAG-FER-IDA-301 \[NCT01114139\]. Participants enrolled in AMAG-FER-IDA-303, a 6-month Extension Study, were evaluated monthly and could receive treatment with ferumoxytol only if they met criteria defined as persistent or recurrent IDA, hemoglobin \<11.0 grams per deciliter (g/dL) and transferrin saturation (TSAT) \<20% at any evaluation visit, (except study termination visit). Participants who met criteria began a 5-week treatment period (TP) and received 2 doses of ferumoxytol 510 mg intravenously (IV). The first IV 510-mg dose was administered on TP Day 1 (Baseline); the second 2-8 (5±3) days after Dose 1. The first treatment course with ferumoxytol for participants who previously received placebo in AMAG-FER-IDA-301 was considered Course 1; Course 2 included participants who previously received ferumoxytol in AMAG-FER-IDA-301; subsequent treatment courses were serially numbered.
Interventions: intervention 1: Ferumoxytol
Intervention descriptions: intervention 1: IV Ferumoxytol

Protocol documents:
Clinical trial NCT00151320
Conditions: Non-Hodgkin's Lymphoma
Keywords: diffuse large B cell mantle cell lymphoma
Sponsor: Weill Medical College of Cornell University
Start date: 2004-01-01; Completion date: 2013-04-24
Enrollment: 76 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective:

To determine the toxicity profile and maximum tolerated dose (MTD) of VELCADE when administered in combination with CHOP + Rituximab to patients with previously untreated diffuse large B cell or mantle cell non-Hodgkin's lymphoma (NHL)

Secondary Objectives:

To assess the response rate (overall and complete), event-free survival and overall survival with VELCADE and CHOP-R in patients with previously untreated diffuse large B cell or mantle cell lymphoma (phase II component)

Treatment:

Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles

Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)

VELCADE is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:

Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4

Detailed description:
Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles

Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)

VELCADE is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:

Once completed six cycles of therapy (\~18 weeks), patients will be evaluated every 3 months for the first year post treatment, then every 6 months until disease progression or death for years 2 through 5 post treatment. Patients who have disease progression will be contacted every 6 months until death to assess for survival status.

Arms: arm 1: Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles

Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)

VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by a dose escalation schedule.
Interventions: intervention 1: Bortezomib, CHOP, Rituximab
Intervention descriptions: intervention 1: Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)

VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:

Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4

Protocol documents:
Clinical trial NCT01638000
Conditions: Urologic Diseases Urinary Bladder, Overactive Urinary Bladder Diseases
Keywords: Vesitrim Frequency Urgency Urgency incontinence Urinary incontinence Overactive Bladder (OAB) Micturition Mirabegron YM178 Vesicare Solifenacin
Sponsor: Astellas Pharma Europe Ltd.
Start date: 2012-06-12; Completion date: 2013-04-24
Enrollment: 1887 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.

Detailed description:

Arms: arm 1: Participants who received mirabegron 50 mg once daily for 12 weeks. arm 2: Participants who received solifenacin 5 mg once daily for 12 weeks.
Interventions: intervention 1: Mirabegron intervention 2: Solifenacin succinate
Intervention descriptions: intervention 1: oral tablet intervention 2: oral tablet

Protocol documents:
Clinical trial NCT01512108
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2012-01-10; Completion date: 2013-04-26
Enrollment: 363 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial was conducted in Japan. The aim of this trial was to evaluate the safety and efficacy of once daily administration of liraglutide in combination with an oral anti-diabetic drug (OAD) in Japanese subjects with type 2 diabetes who are insufficiently controlled on OAD monotherapy. All subjects will continue their pre-trial OAD (either glinide, metformin, alpha-glucosidase inhibitor or thiazolidinedione) during the trial at unchanged type and dose.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: liraglutide intervention 2: oral anti-diabetic drug
Intervention descriptions: intervention 1: 0.9 mg/day liraglutide was injected once daily subcutaneously (s.c., under the skin). intervention 2: An additional oral anti-diabetic drug (OAD) with a different mechanism of action than the pre-trial OAD. The type and dosage of the additional OAD should be chosen by the investigator within the Japanese labelled dose.

Protocol documents:
Clinical trial NCT01807000
Conditions: Healthy
Sponsor: Shire
Start date: 2013-03-18; Completion date: 2013-04-28
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of \[14C\] Prucalopride Succinate in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study is to investigate how and how quickly Prucalopride Succinate or its break down products are excreted by analysing blood, faeces and urine samples collected during the study.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Radiolabeled Prucalopride Succinate
Intervention descriptions: intervention 1: A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.

Protocol documents:
Clinical trial NCT01494584
Conditions: Epilepsy
Sponsor: GlaxoSmithKline
Start date: 2012-07-25; Completion date: 2013-04-29
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of ezogabine/retigabine in subjects aged 12 years to less than 18 years with uncontrolled partial onset seizures or Lennos-Gastaut syndrome.

Detailed description:

Arms: arm 1: ezogabine dose escalation
Interventions: intervention 1: ezogabine/retigabine
Intervention descriptions: intervention 1: ezogabine dose escalation

Protocol documents:
Clinical trial NCT01437540
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD Chronic Obstructive Pulmonary Disease Chronic Bronchitis Emphysema Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease
Sponsor: AstraZeneca
Start date: 2011-09-19; Completion date: 2013-04-30
Enrollment: 590 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive pulmonary disease (COPD).

Detailed description:

Arms: arm 1: Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg fixed dose combination (FDC), high dose twice per day arm 2: Inhaled formoterol fumarate 12 μg, twice per day
Interventions: intervention 1: Aclidinium Bromide/Formoterol Fumarate intervention 2: Formoterol Fumarate
Intervention descriptions: intervention 1: Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg, high dose twice per day intervention 2: Inhaled formoterol fumarate 12 μg, twice per day

Protocol documents:
Clinical trial NCT00065507
Conditions: Hepatitis B
Keywords: hepatic decompensation
Sponsor: Bristol-Myers Squibb
Start date: 2003-08-01; Completion date: 2013-05-01
Enrollment: 195 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation. The patients are treated for 96 weeks after the last subject is randomized.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Entecavir (ETV) intervention 2: Adefovir (ADV)
Intervention descriptions: intervention 1: Tablets, Oral, 1 mg once daily, 96 weeks from the time the last patient is randomized intervention 2: Tablets, Oral, 10 mg, once daily, 96 weeks from the time the last patient is randomized

Protocol documents: