ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00622440
Conditions: Anus Neoplasms
Keywords: HSIL HGAIN AIN neoplasia dysplasia TCM Traditional Chinese Medicine
Sponsor: University of California, San Francisco
Start date: 2008-05-14; Completion date: 2012-12-12
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out if a Chinese herbal cream is effective in treating HSIL (high-grade squamous intraepithelial lesions, also known as HGAIN, or high-grade anal intraepithelial neoplasia).

Detailed description:
The purpose of this study is to test a new noninvasive topical cream, AIJP (Arnebia Indigo Jade Pearl), for treatment of precancerous anal lesions in order to prevent their progression to anal cancer. AIJP is a topical Chinese herbal cream that has been specifically designed to treat people with the cancer precursor lesions caused by human papillomavirus (HPV). In general, HPV infection is a key factor in development of cervical, anal and vulvar cancers. People with HIV are especially vulnerable to develop anal cancer associated with HPV. It is known that prior to development of anal cancer a person develops a precancerous condition known as a high-grade squamous intraepithelial lesion (HSIL). Treatment of the HSIL can prevent progression to anal cancer. Current therapies for HSIL and anal cancer are highly invasive. A new effective noninvasive topical therapy for precancerous HSIL could have a high impact on prevention of anal cancer.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AIJP (Arnebia Indigo Jade Pearl) intervention 2: Placebo
Intervention descriptions: intervention 1: Participants will administer their own treatment using 1/4 teaspoon of the cream twice daily for 48 weeks. intervention 2: Placebo twice daily for 48 weeks.

Protocol documents:
Clinical trial NCT01475305
Conditions: RSV Infection
Keywords: Respiratory Syncytial Virus (RSV) Healthy adults MEDI-557 Intranasal challenge Human model
Sponsor: MedImmune LLC
Start date: 2011-10-20; Completion date: 2012-12-13
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to evaluate the suitability of the challenge model in measuring the efficacy of MEDI-557 compared to placebo in healthy adult participants for the reduction in the incidence of RSV through 12 days post-RSV challenge with the RSV Memphis-37 strain.

Detailed description:
This is designed to be a double-blind, placebo-controlled, randomized study. Approximately 30 participants will be randomized, dosed and followed. Participants will be randomly assigned to receive a single intravenous (IV) dose of MEDI-557 or placebo. Participants will be inoculated with RSV-A. Participants will be followed for efficacy for 12 days post-RSV challenge. Safety follow-up will be approximately 12 months from randomization.

Arms: arm 1: Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3. arm 2: Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
Interventions: intervention 1: Placebo intervention 2: MEDI-557
Intervention descriptions: intervention 1: Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3. intervention 2: Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.

Protocol documents:
Clinical trial NCT01244191
Conditions: Non Squamous, Non-small-cell Lung Cancer
Keywords: Non squamous, non-small-cell lung cancer Epidermal growth factor receptor c-Met inhibitor
Sponsor: Daiichi Sankyo
Start date: 2011-01-11; Completion date: 2012-12-15
Enrollment: 1048 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to determine if the combination regimen of tivantinib with erlotinib will improve overall survival relative to erlotinib alone in subjects with locally advanced or metastatic non-squamous, non-small cell lung cancer who have received 1 or 2 prior systemic anti-cancer therapies.

Detailed description:

Arms: arm 1: Tivantinib 720 mg daily (360 mg twice a day) in combination with 150 mg of erlotinib, given once a day arm 2: Tivantinib placebo given twice a day in combination with 150 mg of erlotinib, given once a day
Interventions: intervention 1: Tivantinib intervention 2: Placebo intervention 3: Erlotinib
Intervention descriptions: intervention 1: Tivantinib 720 mg daily as 3 x 120 mg oral tablets given twice a day intervention 2: Tivantinib Placebo tablets given twice a day intervention 3: Erlotinib 150 mg oral tablets, given once a day

Protocol documents:
Clinical trial NCT01424228
Conditions: Constipation
Keywords: Long term Constipation Digestive signs and symptoms
Sponsor: Shire
Start date: 2011-04-06; Completion date: 2012-12-19
Enrollment: 364 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to evaluate the long-term (24 weeks) efficacy of prucalopride versus placebo in subjects aged 18 years and older with chronic constipation.

Detailed description:
In this phase IV trial a total of 340 subjects (170 subjects per treatment group), with chronic constipation, are planned to be randomly assigned to double-blind treatment.

The trial duration for a subject can be 26 to 28 weeks in total, including a 2- to 4-week run-in phase followed by a 24-week double-blind treatment phase. The patient will complete an e-diary.

Adult subjects (≥18 to \<65 years of age) will take 2 mg prucalopride or matching placebo throughout the entire 24-week treatment period. Elderly subjects (≥65 years of age) will start at a dose of 1 mg prucalopride or matching placebo. In case of insufficient response the daily dose has to be increased to 2 mg (i.e. changed to 2 mg prucalopride or matching placebo).

Arms: arm 1: Placebo 2 mg tablet once daily before breakfast arm 2: Prucalopride 2 mg once daily before breakfast
Interventions: intervention 1: placebo intervention 2: prucalopride
Intervention descriptions: intervention 1: Placebo matching tablet 2 mg once daily before breakfast for 24 weeks intervention 2: Prucalopride 2 mg daily before breakfast

1 mg for subjects \>65 years; in case of insufficient response 2 mg at week 2 or week 4

Protocol documents:
Clinical trial NCT01155466
Conditions: Parkinson Disease
Keywords: Idiopathic Parkinson Disease Idiopathic Parkinson's Disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-07-14; Completion date: 2012-12-20
Enrollment: 778 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
When a patient with Parkinson's disease (PD) is initially treated with L-dopa or dopamine agonists, the symptoms of PD improve or disappear. After several years of taking L dopa or dopamine agonists, patients notice that their PD medications wear off sooner than when they first started taking them. This "wearing off" is characterized by the return of symptoms (i.e., tremor, slowness, and rigidity) and may occur over the course of a few minutes to an hour. When a patient's PD symptoms have returned, the patient is said to be in the "off" state. When the patient takes another dose of medication, and his/her PD symptoms improve or resolve, the patient is said to be in the "on" state. Antagonism of adenosine Type 2a receptors (A2a) may provide relief of PD symptoms. This trial will test the hypothesis that A2a receptor antagonism can lead to improvement in the function of PD participants taking a stable dose of L-dopa, as measured by a reduction in "off" time.

Detailed description:

Arms: arm 1: Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks arm 2: Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks arm 3: Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks arm 4: Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks arm 5: Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
Interventions: intervention 1: Preladenant 2 mg tablet intervention 2: Preladenant 5 mg tablet intervention 3: Preladenant 10 mg tablet intervention 4: Placebo to Preladenant Tablet intervention 5: Rasagiline 1 mg capsule intervention 6: Placebo to Rasagiline capsule
Intervention descriptions: intervention 1: one 2 mg tablet orally twice daily intervention 2: one 5 mg tablet orally twice daily intervention 3: one 10 mg tablet orally twice daily intervention 4: one tablet orally twice daily intervention 5: one 1 mg capsule orally in AM intervention 6: one capsule orally in AM

Protocol documents:
Clinical trial NCT01640873
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-09-19; Completion date: 2012-12-20
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the initial safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-8655, after single and multiple daily oral administrations to participants with Type 2 Diabetes (T2DM). The study will assess the reduction in fasting plasma glucose concentrations from baseline after multiple daily administrations of MK-8655.

Detailed description:

Arms: arm 1: Participants received a single dose of MK-8655, 80 mg on Day 1 and then MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days. arm 2: Participants received a single dose of placebo to MK-8655, 80 mg on Day 1 and then placebo to MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days.
Interventions: intervention 1: MK-8655 intervention 2: Placebo
Intervention descriptions: intervention 1: Participants will receive MK-8655 as a single dose on Day 1. Participants will receive MK-8655, once a day (q.d.), for 14 consecutive days (Day 3 through Day 16). MK-8655 doses may be adjusted downward based on the results of ongoing studies. intervention 2: Participants will receive Placebo as a single dose on Day 1. Participants will receive Placebo, q.d., for 14 consecutive days (Day 3 through Day 16).

Protocol documents:
Clinical trial NCT00975221
Conditions: Hyperparathyroidism, Primary Hypercalcemia
Keywords: Primary hyperparathyroidism Parathyroidectomy Hypercalcemia
Sponsor: Amgen
Start date: 2010-03-10; Completion date: 2012-12-21
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to demonstrate the efficacy and to assess the safety of cinacalcet for the reduction of hypercalcemia in patients with primary hyperparathyroidism for whom parathyroidectomy is indicated on the basis of an elevated corrected total serum calcium, but who are unable to undergo parathyroidectomy.

Detailed description:
The study will consist of a 30-day screening phase, a 12-week placebo-controlled dose-titration phase, and a 16-week placebo-controlled efficacy assessment phase (EAP). Participants who complete 28 weeks on study will continue into an open-label safety extension phase for 24 weeks of investigational cinacalcet treatment.

Arms: arm 1: Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52. arm 2: Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
Interventions: intervention 1: Cinacalcet intervention 2: Placebo
Intervention descriptions: intervention 1: Administered orally at a starting dose of 30 mg twice a day (BID). Participants will be eligible for a dose titration once every 3 weeks during the placebo-controlled dose titration phase based on corrected total serum calcium concentration and safety assessments obtained the previous week. Doses may be sequentially increased to 60 mg BID, 90 mg BID, and 90 mg 3 times a day (TID). intervention 2: Administered orally following the same tiitration regimen as the experimental arm.

Protocol documents:
Clinical trial NCT01290302
Conditions: Myelodysplastic Syndrome Myelofibrosis Chronic Myeloid Leukemia Chronic Lymphocytic Leukemia
Sponsor: American Regent, Inc.
Start date: 2010-11-22; Completion date: 2012-12-21
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the bioequivalence of subcutaneous Vidaza® and subcutaneous Luitpold Azacitidine pharmacokinetics and to assess the comparative safety of subcutaneous Vidaza® versus subcutaneous Luitpold Azacitidine.

Detailed description:
To assess the bioequivalence of Vidaza® and Luitpold Azacitidine pharmacokinetics, in terms of Maximal Concentration (Cmax), Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC 0-t), and Area Under the Curve From Time Zero Extrapolated to Infinity (AUC 0-∞), following SC administration.

To assess the comparative safety of Vidaza® versus Luitpold Azacitidine during the 2 day study period.

Arms: arm 1: Participants first received Luitpold Azacitidine subcutaneously (SC) on Day 1. After a washout period of 24 hours, they then received Vidaza on Day 2. arm 2: Participants first received Vidaza subcutaneously (SC) on Day 1. After a washout period of 24 hours, they then received Luitpold Azacitidine on Day 2.
Interventions: intervention 1: Luitpold Azacitidine intervention 2: Vidaza®
Intervention descriptions: intervention 1: Subcutaneous (SC) at a dose of 75 mg/m\^2 per day on days 1 and 2 of a treatment cycle intervention 2: Subcutaneous (SC) at a dose of 75 mg/m\^2 per day on days 1 and 2 of a treatment cycle

Protocol documents:
Clinical trial NCT01627327
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Cardiovascular event Cardiovascular disease
Sponsor: GlaxoSmithKline
Start date: 2012-04-01; Completion date: 2012-12-21
Enrollment: 623 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg once daily compared with tiotropium bromide inhalation powder 18mcg once daily over a 12-week treatment period in subjects with COPD who have or are at risk for co-morbid cardiovascular disease

Detailed description:
This is a randomized, double-blind, double-dummy, multi-center, parallel-group study. Subjects who meet the eligibility criteria at Screening and at the end of a 2-week Run-In Period will enter a 12-week Treatment Period. There will be a 7-day Follow-up Period after the Treatment Period.

Arms: arm 1: inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) arm 2: anticholinergic
Interventions: intervention 1: fluticasone furoate/vilanterol 100/25mcg intervention 2: tiotropium bromide 18mcg
Intervention descriptions: intervention 1: inhalation powder intervention 2: inhalation powder

Protocol documents:
Clinical trial NCT00687323
Conditions: Leukemia, Acute Myeloid Myelodysplastic Syndrome
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-07-30; Completion date: 2012-12-23
Enrollment: 47 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the safety, tolerability, and efficacy of temozolomide in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) participants who are not candidates for standard induction therapy and exhibit low MGMT expression.

Detailed description:

Arms: arm 1: Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m\^2/day for 7 days in 1 28 day cycle), then 200 mg/m\^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m\^2/day for 21 days of each 28-day cycle (12 cycle maximum).
Interventions: intervention 1: temozolomide
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01076088
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-11-15; Completion date: 2012-12-24
Enrollment: 744 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy and safety of initial treatment with sitagliptin and metformin in patients with type 2 diabetes mellitus in China. The primary hypothesis is that after 24 weeks, initial co-administration treatment with sitagliptin and metformin provided greater reduction in hemoglobin A1C (A1C) compared to initial treatment with sitagliptin alone and with metformin alone.

Detailed description:

Arms: arm 1: Sitagliptin 50 mg and metformin 500 mg twice a day for 24 weeks. arm 2: Sitagliptin 50 mg and metformin 850 mg twice a day for 24 weeks. arm 3: Metformin 500 mg twice daily for 24 weeks. arm 4: Metformin 850 mg twice daily for 24 weeks. arm 5: Sitagliptin 100 mg once daily for 24 weeks. arm 6: Matching placebo tablets for 24 weeks.
Interventions: intervention 1: Sitagliptin 50 mg intervention 2: Metformin 500 mg intervention 3: Sitagliptin 100 mg intervention 4: Placebo intervention 5: Metformin 850 mg
Intervention descriptions: intervention 1: Sitagliptin 50 mg tablet twice a day, prior to the morning and evening meal, for 24 weeks. intervention 2: Metformin 500 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks. intervention 3: Sitagliptin 100 mg once daily for 24 weeks. intervention 4: Matching placebo tablets to sitagliptin or metformin for 24 weeks. intervention 5: Metformin 850 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.

Protocol documents:
Clinical trial NCT01286467
Conditions: Solid Tumors
Keywords: PF-04449913 Hedgehog Inhibitor Solid tumor Pharmacokinetics Safety Pharmacodynamics
Sponsor: Pfizer
Start date: 2011-05-11; Completion date: 2012-12-28
Enrollment: 23 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select solid tumors.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: PF-04449913
Intervention descriptions: intervention 1: Escalating dose of PF-04449913 administered as tablets PO QD in 28-day cycles

Protocol documents:
Clinical trial NCT00957580
Conditions: Leukemia, Myeloid, Acute Hematologic Neoplasms
Keywords: MEK Inhibitor Pimasertib Acute Myeloid Leukemia Hematological Malignancies Elderly Patients Phase II
Sponsor: EMD Serono
Start date: 2009-09-30; Completion date: 2012-12-31
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label, multi-center, dose-escalation trial of pimasertib (MSC1936369B) in blood and bone marrow cancers. The trial will be conducted in two parts:

Part 1 (safety run-in period): Will determine the maximum tolerated dose (MTD) of the study drug in subjects with advanced hematological malignancies.

Part 2: Will assess the anti-leukemic activity of the study drug in older subjects with newly diagnosed poor prognosis acute myeloid leukemia (AML) who are not candidates for intensive chemotherapy.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Pimasertib intervention 2: Pimasertib intervention 3: Pimasertib intervention 4: Pimasertib intervention 5: Pimasertib
Intervention descriptions: intervention 1: Pimasertib will be administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose will be escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) is reached. The treatment will be continued until disease progression, intolerable toxicity, or Investigator/subject decision. intervention 2: Pimasertib will be administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose will be escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD is reached. The treatment will be continued until disease progression, intolerable toxicity, or Investigator/subject decision. intervention 3: Pimasertib will be administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose escalation will proceed to 75 mg BID until MTD is reached. The treatment will be continued until disease progression, intolerable toxicity, or Investigator/subject decision. intervention 4: Pimasertib will be administered orally twice daily on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. Dose will be determined by Part 1 of the trial (could be the MTD or lower dose level). The treatment will be continued until disease progression, intolerable toxicity, or Investigator/subject decision. intervention 5: Pimasertib will be administered orally twice daily on Days 1 to 21 of a 28-day cycle. Dose will be determined by Part 1 of the trial (could be the MTD or lower dose level). The treatment will be continued until disease progression, intolerable toxicity, or Investigator/subject decision.

Protocol documents:
Clinical trial NCT00474786
Conditions: Renal Cell Carcinoma
Keywords: Metastatic or Advanced Renal Cell Carcinoma
Sponsor: Pfizer
Start date: 2007-09-01; Completion date: 2013-01-01
Enrollment: 512 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an international, randomized, open-label, outpatient, multicenter study. Subjects will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These investigational drugs will be administered in 6-week cycles for the duration of the study, up to 24 months. Subjects will be stratified by nephrectomy status, duration of response to sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC tumor histology.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sorafenib intervention 2: temsirolimus (Torisel)
Intervention descriptions: intervention 1: Subjects randomized to arm B will take sorafenib 400 mg (2 x 200 mg tablets) PO, BID (total daily dose of 800 mg). intervention 2: Subjects randomized to arm A will receive temsirolimus (Torisel) 25 mg via IV infusion once weekly. This infusion is to be administered over a 30-60 minute period. Subjects are to be pre-treated with 25-50 mg IV diphenhydramine (or comparable IV antihistamine) approximately 30 minutes before temsirolimus infusion.

Protocol documents: