ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01126801
Conditions: Menopausal Depression
Sponsor: Massachusetts General Hospital
Start date: 2010-05-01; Completion date: 2011-02-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This protocol is a controlled study of estradiol therapy in early postmenopausal women with and without frequent hot flashes that will be used to determine whether hot flashes are an important intermediary in the generation of menopause-associated depression.

Detailed description:
SPECIFIC AIMS (Research Objectives)

To define the relative effects of hot flashes and changes in estradiol on mood in postmenopausal women:

Hypotheses:

1. Estrogen treatment has a similar therapeutic effect on mood in women with and without frequent hot flashes
2. Estradiol levels correlate with improvement in mood

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Estradiol intervention 2: Placebo control
Intervention descriptions: intervention 1: Oral estradiol 1.0 mg/day for four weeks. intervention 2: Placebo control matched to estradiol tablets. Daily dosing for one month.

Protocol documents:
Clinical trial NCT01147458
Conditions: Osteoarthritis, Knee
Keywords: Cross-over safety efficacy tolerability osteoarthritis knee pain
Sponsor: Pfizer
Start date: 2010-07-01; Completion date: 2011-02-01
Enrollment: 190 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
PF-04191834 works in animal models by inhibiting one of the enzymes, 5-lipoxygenasein which is involved in the pathway that causes inflammation and pain. The purpose of this study is to test how effective, safe and tolerated PF-04191834 is in patients with osteoarthritis of the knee by itself or with naproxen, particularly to test if patients have less pain.

Detailed description:
This study has been terminated in response to a reported serious adverse event (SAE). The sponsor's assessment of the limited data available at the time of the initial SAE report was that the SAE may alter the potential benefit - risk profile of the study medication.

Arms: arm 1: PF-04191834 600 mg BID dose followed by matched placebo plus naproxen placebo. arm 2: Placebo followed by 600 mg BID dose of PF-04191834 plus naproxen placebo. arm 3: PF-04191834 600 mg BID + Naproxen 500 mg BID followed by Naproxen 500 mg BID plus PF-04191834 placebo arm 4: Naproxen 500 mg BID followed by PF-04191834 600 mg BID + Naproxen 500 mg BID
Interventions: intervention 1: PF-04191834 intervention 2: PF-04191834 placebo intervention 3: Naproxen placebo intervention 4: PF-04191834 placebo intervention 5: PF-04191834 intervention 6: Naproxen placebo intervention 7: PF-04191834 intervention 8: Naproxen intervention 9: PF-04191834 placebo intervention 10: Naproxen intervention 11: PF-04191834 placebo intervention 12: PF-04191834
Intervention descriptions: intervention 1: 100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks intervention 2: Matching PF-04191834 placebo tablets to be administered BID for two weeks intervention 3: Matching naproxen placebo tablets to be administered BID for 4 weeks intervention 4: Matching PF-04191834 placebo tablets to be administered BID for two weeks intervention 5: 100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks intervention 6: Matching naproxen placebo tablets to be administered BID for 4 weeks intervention 7: 100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks intervention 8: Naproxen 500 mg tablet administered BID for a total of four weeks intervention 9: Matching PF-04191834 placebo tablets to be administered BID for two weeks intervention 10: Naproxen 500 mg tablet administered BID for a total of four weeks intervention 11: Matching PF-04191834 placebo tablets to be administered BID for two weeks intervention 12: 100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks

Protocol documents:
Clinical trial NCT01149681
Conditions: Myelofibrosis
Keywords: Aplidin Plitidepsin Myelofibrosis Pharma Mar
Sponsor: PharmaMar
Start date: 2010-07-01; Completion date: 2011-02-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, Phase II Clinical Trial of Aplidin® (plitidepsin) in Patients with Primary Myelofibrosis and post polycythemia vera/essential thrombocythemia (Post-PV/ET) Myelofibrosis.

Detailed description:
This trial tries to assess response rate (ORR) of plitidepsin in patients with:

primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF). Besides, the study results will allow to evaluate the effect of plitidepsin on bone marrow (BM) or peripheral blood histology and to determine the quality of life (QoL) and symptoms or participant patients.

Arms: arm 1: None
Interventions: intervention 1: APLIDIN (plitidepsin)
Intervention descriptions: intervention 1: Aplidin® (plitidepsin) lyophilized powder and solvent for concentrate for solution for infusion. (2 mg plitidepsin vial and 4 ml ampoule).

Plitidepsin will be administered at 5 mg/m2 intravenously diluted to a total volume of 250 ml in 0.9% saline or 5% dextrose solution on Day 1 and 15 every four weeks for a maximum period of 6 cycles.

Protocol documents:
Clinical trial NCT01152515
Conditions: Tracheal Extubation
Keywords: safety and efficacy of maintaining a remifentanil infusion during extubation in propofol-remifentanil sedated patients after surgery
Sponsor: Severance Hospital
Start date: 2010-05-01; Completion date: 2011-02-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Tracheal extubation can be associated with hyperdynamic circulatory response. The investigators examined the effect of maintaining a remifentanil infusion on the cardiovascular response during extubation in propofol-remifentanil sedated patients after surgery.

Detailed description:

Arms: arm 1: stopping of propofol and remifentanil infusion arm 2: stopping of propofol and maintenance of remifentanil infusion
Interventions: intervention 1: Remifentanil
Intervention descriptions: intervention 1: Control group : stopping of propofol and remifentanil infusion Remifentanil group : stopping of propofol and maintenance of remifentanil infusion

Protocol documents:
Clinical trial NCT01154127
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: NVA237 COPD bronchodilator exercise endurance
Sponsor: Novartis Pharmaceuticals
Start date: 2010-06-01; Completion date: 2011-02-01
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The ability for patients with COPD to exercise is limited due to the deterioration of their lung function. NVA237 is being developed to treat COPD. This study is designed to look at how well NVA237 improves the ability to exercise in patients with moderate to severe COPD.

Detailed description:

Arms: arm 1: Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days

Period 2: Matching placebo via NEOHALER inhaler device for 21 days

The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.

Salbutamol (albuterol) was used as rescue medication throughout the study. arm 2: Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days

Period 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days

The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.

Salbutamol (albuterol) was used as rescue medication throughout the study.
Interventions: intervention 1: NVA237 intervention 2: Placebo
Intervention descriptions: intervention 1: 50 μg via NEOHALER inhaler device single dose dry powder inhaler (SDDPI) once daily intervention 2: Matching placebo via NEOHALER inhaler device single dose dry powder inhaler (SDDPI) once daily

Protocol documents:
Clinical trial NCT01155999
Conditions: Purulent Bacterial Conjunctivitis
Sponsor: Laboratoires Thea
Start date: 2008-12-01; Completion date: 2011-02-01
Enrollment: 286 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis of children.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: T1225 intervention 2: Tobramycin
Intervention descriptions: intervention 1: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2 intervention 2: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6

Protocol documents:
Clinical trial NCT01189279
Conditions: Alopecia Alopecia, Androgenetic Baldness
Sponsor: Allergan
Start date: 2010-10-01; Completion date: 2011-02-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the safety, tolerability, and pharmacokinetics of new formulation of bimatoprost following topical application in patients with alopecia. Two formulations of bimatoprost will be investigated in Part 1 and a third formulation of bimatoprost will be investigated in Part 2. Part 2 will begin after Part 1 has completed.

Detailed description:

Arms: arm 1: bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17. arm 2: bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17. arm 3: bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
Interventions: intervention 1: bimatoprost Formulation A intervention 2: bimatoprost Formulation B intervention 3: bimatoprost Formulation C
Intervention descriptions: intervention 1: bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17. intervention 2: bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17. intervention 3: bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.

Protocol documents:
Clinical trial NCT01193127
Conditions: Cataract
Sponsor: Omeros Corporation
Start date: 2010-07-01; Completion date: 2011-02-01
Enrollment: 223 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to determine whether the use of OMS302 (the study drug) in individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and effective at maintaining an adequately dilated pupil during surgery and reducing post-operative symptoms of discomfort (such as eye pain and irritation).

Detailed description:

Arms: arm 1: OMS302 Solution arm 2: OMS302 Mydriatic Solution arm 3: OMS302 Anti-inflammatory Solution arm 4: Balanced Salt Solution (BSS) Solution
Interventions: intervention 1: OMS302 Solution intervention 2: OMS302 Mydriatic Solution intervention 3: OMS302 Anti-inflammatory Solution intervention 4: Balanced Salt Solution (BSS) Solution
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01207401
Conditions: Pain Control for Intrauterine Device Insertions
Keywords: intrauterine device local anesthetic
Sponsor: Northwestern University
Start date: 2010-07-01; Completion date: 2011-02-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate if a paracervical block containing 1% lidocaine administered prior to IUD insertion reduces insertion pain. The hypothesis is that women receiving paracervical analgesia will experience less pain during IUD insertion than those who do not receive such analgesia.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lidocaine
Intervention descriptions: intervention 1: 1% Lidocaine

Protocol documents:
Clinical trial NCT01214655
Conditions: Acute Leukemia
Keywords: Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Chronic Myelogenous Leukemia,Blast Crisis
Sponsor: Eli Lilly and Company
Start date: 2008-06-01; Completion date: 2011-02-01
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a multicenter, nonrandomized, open-label, dose-escalation with intra-patient dose-escalation, Phase 1 study of intravenous LY2523355 to determine the dose of LY2523355 that can be safely administered to participants with acute leukemia. Part A and Part B are dose escalation of two schedules in participants with acute leukemia. Parts A and B will enroll concurrently. Part C is a dose expansion for each schedule in participants with acute myeloblastic leukemia (AML).

Detailed description:

Arms: arm 1: Starting dose was 2 milligrams per meter squared (mg/m\^2) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle. arm 2: Starting dose was 8 milligrams per meter squared (mg/m\^2) administered by a 1-hour IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle.
Interventions: intervention 1: LY2523355
Intervention descriptions: intervention 1: Administered as a 1-hour IV infusion for at least 2 cycles. Cycle length is 21 days. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.

Protocol documents:
Clinical trial NCT01263119
Conditions: Major Depressive Disorder
Sponsor: Eli Lilly and Company
Start date: 2010-12-01; Completion date: 2011-02-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine how warfarin might affect LY2216684 and how giving LY2216684 might affect warfarin in the body. Information about any side effects that may occur will also be collected.

Detailed description:

Arms: arm 1: Period 1: Single 10-milligram (mg) warfarin oral dose on Day 1; Washout Period of at least 14 days; Period 2: 18-mg LY2216684 oral dose, once daily on Days 1 to 12, with single 10-mg warfarin oral dose coadministered on Day 3.
Interventions: intervention 1: Warfarin intervention 2: LY2216684
Intervention descriptions: intervention 1: 10-mg warfarin oral dose intervention 2: 18-mg LY2216684 oral dose

Protocol documents:
Clinical trial NCT01276301
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2011-01-01; Completion date: 2011-02-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Relative bioavailability of BI 10773 given alone and together with verapamil

Detailed description:

Arms: arm 1: single dose BI 10773 arm 2: single dose BI 10773 + single dose verapamil
Interventions: intervention 1: Verapamil intervention 2: BI 10773 intervention 3: BI 10773
Intervention descriptions: intervention 1: single dose verapamil intervention 2: single dose BI 10773 intervention 3: single dose BI 10773

Protocol documents:
Clinical trial NCT01277718
Conditions: Healthy Volunteer
Sponsor: Genentech, Inc.
Start date: 2011-01-01; Completion date: 2011-02-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a Phase 1, single-center, open-label, randomized, 3-period, 2-sequence crossover study of cobimetinib in healthy participants to evaluate the effect of the proton-pump inhibitor (PPI) rabeprazole on the relative bioavailability of cobimetinib in healthy participants when administered in the fed or fasted states.

Detailed description:

Arms: arm 1: Treatment A in Period 1: One 20-mg tablet of cobimetinib will be administered orally with 240 milliliters (mL) room temperature water after at least an 8-hour fast. Treatment B in Period 2: 20 mg oral rabeprazole will be administered once daily for 4 days starting on Day -4. On Day 1, 20 mg rabeprazole will be administered in fasted state followed by one 20-mg tablet of cobimetinib administration orally with 240 mL room temperature water after at least an 8-hour fast. Treatment C in Period 3: 20 mg oral rabeprazole will be administered once daily for 4 days starting on Day -4. On Day 1, 20 mg rabeprazole will be administered in fasted state. Approximately 30 minutes later, participants will be provided a standardized Food and Drug Administration (FDA) high-fat meal, and approximately 30 minutes after starting meal, one 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water. There will be a 13-day washout between cobimetinib doses of each period. arm 2: Treatment A in Period 1: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast. Treatment C in Period 2: 20 mg oral rabeprazole will be administered once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole will be administered in fasted state. Approximately 30 minutes later, participants will be provided a standardized FDA high-fat meal, and approximately 30 minutes after starting meal, one 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water. Treatment B in Period 3: 20 mg oral rabeprazole will be administered once daily for 4 days starting on Day -4. On Day 1 of treatment period, 20 mg rabeprazole will be administered in fasted state followed by one 20-mg tablet of cobimetinib administration orally with 240 mL room temperature water after at least an 8-hour fast. There will be a 13-day washout between cobimetinib doses of each period.
Interventions: intervention 1: Cobimetinib intervention 2: Rabeprazole
Intervention descriptions: intervention 1: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast or approximately 30 minutes after starting the standardized FDA high-fat meal. intervention 2: Rabeprazole 20 mg will be administered orally once daily for 4 days starting on Day -4 and on Day 1 of the treatment period.

Protocol documents:
Clinical trial NCT01278797
Conditions: Hypertension
Sponsor: Boehringer Ingelheim
Start date: 2011-01-01; Completion date: 2011-02-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will be an open-label, randomized, two-treatment, two-period, two-sequence crossover study to evaluate the bioequivalence of the amlodipine component of Boehringer Ingelheim Pharma GmbH \& Co. KGs 80 mg telmisartan/10 mg amlodipine fixed dose combination tablet to the corresponding mono-component amlodipine tablets, 10 mg (Pfizers Norvasc).

Detailed description:

Arms: arm 1: Telmisartan/Amlodipine medium fixed dose combination tablet once daily. arm 2: Amlodipine Monocomponent 10mg tablet once daily
Interventions: intervention 1: Telmisartan/Amlodipine Combination Tablet intervention 2: Amlodipine Monocomponent
Intervention descriptions: intervention 1: Combination Tablet intervention 2: Active Comparator

Protocol documents:
Clinical trial NCT01280591
Conditions: Pain, Postoperative
Keywords: Naproxen sodium Diphenhydramine
Sponsor: Bayer
Start date: 2010-10-01; Completion date: 2011-02-01
Enrollment: 712 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to evaluate the efficacy and safety of a single oral dose of two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than either single ingredient alone in subjects with post-surgical dental pain and phase advanced sleep.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111) intervention 2: Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111) intervention 3: Naproxen sodium 440 mg (BAYH6689) intervention 4: DPH 50 mg
Intervention descriptions: intervention 1: Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose intervention 2: Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose intervention 3: Participants received two Naproxen sodium 220 mg tablets orally, single dose intervention 4: Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Protocol documents:
Clinical trial NCT01293968
Conditions: Aphthous Stomatitis
Keywords: Aphthous Stomatitis Ibuprofen treatment efficacy
Sponsor: Qazvin University Of Medical Sciences
Start date: 2010-11-01; Completion date: 2011-02-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of recurrent aphthous stomatitis (RAS)

Detailed description:
Recurrent aphthous stomatitis (RAS) is the most painful oral lesion with a considerable prevalence . The most common aphthous ulcer treatments include applying topical agents such as antibiotics, Non Steroidal Anti Inflammatory Drugs (NSAIDs) to immunosuppressants.

The mixture of Diphenhydramine and Aluminum MgS suspension has been prescribed as an analgesic mouthwash for a long time in order to decrease a great number of oral ulcers symptoms such as aphthous ulcers. Ibuprofen is a potent NSAID with fair anti-inflammatory potential prescribed in dental pains.

This double-blind randomized clinical trial was conducted to assess the effect of Ibuprofen, Diphenhydramine and Aluminium MgS mixture on symptoms of aphthous ulcers.40 patients will be participating in this study,20 will receive the mixture of Diphenhydramine and Aluminium MgS while the other group will receive Ibuprofen, Diphenhydramine and Aluminium MgS mixture.

All patients will be instructed to apply the drug on the site of the ulcer 30-60 minutes before meals, 3 times daily. The ulcers will be assessed when the drug is applied for 3 days and the level of pain and irritation will be estimated by VAS (Visual Analogue Scale, a scaled ruler which the zero point displays the zone of lack of pain and the 10th point was considered as the zone of maximum pain).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ibuprofen, Diphenhydramine and Aluminium MgS intervention 2: Diphenhydramine and Aluminium MgS
Intervention descriptions: intervention 1: 3 times daily for 3 days intervention 2: 3 times daily for 3 days

Protocol documents:
Clinical trial NCT01359956
Conditions: Malignant Melanoma Recurrent Melanoma
Sponsor: National Cancer Institute, Naples
Start date: 2002-04-01; Completion date: 2011-02-01
Enrollment: 269 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This study evaluated two chemotherapy regimens with and without the addition of interferon in patients with advanced or recurrent melanoma.

Detailed description:

Arms: arm 1: combination chemotherapy without interferon arm 2: combination chemotherapy with interferon arm 3: single agent dacarbazine without interferon arm 4: single agent dacarbazine plus interferon
Interventions: intervention 1: Dacarbazine intervention 2: Fotemustine intervention 3: Interferon Alfa-2b
Intervention descriptions: intervention 1: 900 mg / m2 every 3 weeks intervention 2: 100 mg / m2 every 3 weeks intervention 3: 5 M units every 3 weeks

Protocol documents: