ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02113449
Conditions: Nasal Congestion
Keywords: Carbon Dioxide, Allergy symptoms
Sponsor: GlaxoSmithKline
Start date: 2013-11-01; Completion date: 2014-02-01
Enrollment: 147 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Carbon dioxide (CO2) is a naturally occurring gas that readily diffuses across body tissues and membranes. Data from earlier clinical studies conducted in 975 subjects with allergic rhinitis have shown that nasally administered CO2 may provide relief of the associated symptoms. Symptom relief has been shown to occur as soon as 10 minutes after administration, and may persist for four to six hours.

This study aims to assess the consumer appeal of a prototype CO2 delivery device, as well as evaluate its perceived effectiveness for nasal congestion. Properly consented subjects who qualify and choose to participate in the clinical study will be administered nasal CO2 under medical supervision, wait a period of 1 hour in clinic, and then be dispensed a device for self-treatment at home. Subjects will return to the clinic on day 7 for final evaluation and completion of assessment questionnaires.

Detailed description:
This study will be conducted in two parts. In the first part of the study, recruited subjects with nasal congestion will view a description of a new treatment option (concept). Interested subjects will be offered the opportunity to enter the clinical trial. Subjects who consent and are found otherwise eligible will then receive one dose of CO2 in the study clinic under medical supervision. Afterward, subjects who wish to continue will be allowed to take the administration device home for an additional six days of use (study part 2).

During the at-home use portion of the study, subjects will use a diary to record the number of times the product was used and their nasal congestion symptoms before and after use.

At the end of the study period, subjects will return to the study center for global assessment of their impressions of treatment and to answer questions designed to estimate market acceptability. Subjects may be asked to participate voluntarily in a market research focus group following their participation in this study.

Arms: arm 1: Participants will receive one dose of nasal carbon dioxide (CO2) in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day.
Interventions: intervention 1: Carbon Dioxide
Intervention descriptions: intervention 1: Nasal administration of carbon dioxide (CO2) through the delivery device for 10 seconds

Protocol documents:
Clinical trial NCT02198235
Conditions: Postoperative Pain
Sponsor: Hospital for Special Surgery, New York
Start date: 2012-10-01; Completion date: 2014-02-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study looks at addition of medications to the local anesthetic for the nerve blockade.

Detailed description:
Following major foot and ankle surgery patients complain of severe pain. Currently, Hospital for Special Surgery (HSS) usually uses nerve blocks (injections of local anesthetic near nerves supplying the lower leg) to help manage pain after this type of surgery. Patients also receive additional pain pills, including narcotics as needed. This study looks at addition of medications to the local anesthetic for the nerve blockade. The investigators hope that these medications (dexamethasone and buprenorphine) will prolong the pain relief from the nerve block. There are 3 groups in the study. One group is a control, and receives usual therapy: nerve block + pain pills. This is typically what the patient would receive as standard care if they were not in the study. One group uses a nerve block with additives (+ pain pills). One group gets a nerve block (local anesthetic only) + pain pills + intravenous buprenorphine - this is meant to see if the buprenorphine acts directly on the nerve that was blocked, or indirectly acts on the brain.

Patients will be followed while in the hospital, and contacted by telephone and/or email after discharge for 2-3 days. Patients will be asked about their pain levels and the duration of their block. The investigators will enroll 90 patients.

Arms: arm 1: IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg) arm 2: IV Dexamethasone (4 mg) arm 3: Dexamethasone (4 mg) Buprenorphine (150 mcg)
Interventions: intervention 1: Dexamethasone intervention 2: Buprenorphine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02447458
Conditions: Healthy Volunteers
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2013-09-01; Completion date: 2014-02-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics of MLN3126 when administered as a single dose of tablets at escalating dose levels in healthy participants.

Detailed description:
The drug tested in this study is called MLN3126. The study evaluated the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and the potential effect of food on the PK of MLN3126 and its M-I metabolite following single oral dose administrations.

This study planned to enroll approximately 48 healthy participants, who were to be enrolled in 1 of the 6 dose cohorts or matching placebo in an ascending fashion. Participants were randomly assigned to MLN3126 or placebo within each cohort- which remained undisclosed to the participant and study doctor during the study (unless there was an urgent medical need):

* Cohort 1 - MLN3126 300 mg or matching placebo
* Cohort 2 - MLN3126 600 mg or matching placebo
* Cohort 3 - MLN3126 1000 mg or matching placebo
* Cohort 3 - MLN3126 1000 mg or matching placebo (fed regimen)
* Cohort 4 - MLN3126 1500 mg or matching placebo
* Cohort 5 - MLN3126 2000 mg or matching placebo
* Cohort 6 - Did not taken place due to termination of the study

All participants were asked to take the required tablets at the same time throughout the study.

This single-centre trial was conducted in The United States. Participants were confined to the clinic for 5 days, and were contacted by telephone on day 14 (±2days) for a follow-up assessment.

This study was terminated after completion of Cohort 5 due to findings of study site non-compliance to Good Clinical Practice (GCP) regarding study documentation. There were no safety concerns.

Arms: arm 1: MLN3126 300 mg tablets, orally, fasting, once on Day 1. arm 2: MLN3126 600 mg tablets, orally, fasting, once on Day 1. arm 3: MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1. arm 4: MLN3126 1500 mg administered orally as tablets, once on Day 1. arm 5: MLN3126 2000 mg tablets, orally, fasting, once on Day 1. arm 6: Did not take place due to termination of the study. arm 7: Placebo-matching MLN3126 tablets, orally, once on Day 1.
Interventions: intervention 1: MLN3126 intervention 2: MLN3126 Placebo
Intervention descriptions: intervention 1: MLN3126 tablets intervention 2: MLN3126 placebo-matching tablets

Protocol documents:
Clinical trial NCT03651856
Conditions: Parkinson's Disease Freezing of Gait
Sponsor: Medical University of South Carolina
Start date: 2013-01-01; Completion date: 2014-02-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Subjects are being asked to participate in this study to determine the safety and effectiveness of a drug called atomoxetine in the treatment of freezing of gait for Parkinson's Disease patients. Atomoxetine (ATM) is an approved drug currently on the market for the treatment of attention deficit. It works to increase the amount of norepinephrine (a chemical in the brain that helps keep us awake and alert) in our brain. ATM has not been approved by the Food and Drug Administration (FDA) to be used in the treatment of PD, but has been found to be well tolerated in this patient population.

Detailed description:

Arms: arm 1: Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off
Interventions: intervention 1: ATM FOG in PD
Intervention descriptions: intervention 1: open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait

Protocol documents:
Clinical trial NCT01949051
Conditions: Rhinitis, Allergic, Perennial and Seasonal
Keywords: Allergic rhinitis levocabastine allergen challenge
Sponsor: GlaxoSmithKline
Start date: 2013-10-01; Completion date: 2014-02-04
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will be a randomized, double blind, placebo controlled, 3-way cross over design in allergic rhinitis subjects. Subjects will receive repeat doses of intra-nasal levocabastine for 7 days in each period and the duration of the study will be about 13 weeks. An Environmental Exposure Chamber (EEC) will be used in this study. The primary objective of the study is to investigate the non-inferiority effect of 7 days treatment with levocabastine on nasal symptoms elicited by an EEC when administered once daily (QD) compared with twice daily (BID). Also study will be conducted to investigate the superiority of effect of 7 days treatment with levocabastine (QD and BID) on nasal symptoms elicited by an EEC in subjects compared to placebo.

Detailed description:

Arms: arm 1: Subjects will be assigned to one of six treatment sequences (ABC, BCA, CAB, ACB, BAC, CBA) in accordance with the randomisation schedule. A = Two, 50 microgram (mcg) sprays per nostril of levocabastine QD in the morning. Total dose of 200 mcg. Two, 0 mcg sprays from placebo to match vehicle in the evening; B = Two, 50 mcg sprays per nostril of levocabastine BID in the morning and evening. Total dose of 400 mcg; C = Two, 0 mcg sprays per nostril from placebo vehicle in morning and evenings.
Interventions: intervention 1: Levocabastine intervention 2: Placebo
Intervention descriptions: intervention 1: Intranasal aqueous 50 mcg microsuspension of levocabastine supplied in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension intervention 2: Intranasal aqueous 0 mcg microsuspension supplied in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension

Protocol documents:
Clinical trial NCT01765764
Conditions: Eyebrow Hypotrichosis
Sponsor: Allergan
Start date: 2013-03-13; Completion date: 2014-02-11
Enrollment: 357 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of bimatoprost solution compared with vehicle in the treatment of eyebrow hypotrichosis (inadequate eyebrows).

Detailed description:

Arms: arm 1: Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months. arm 2: Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months. arm 3: Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
Interventions: intervention 1: bimatoprost solution intervention 2: Vehicle to bimatoprost solution
Intervention descriptions: intervention 1: Bimatoprost solution once a day or twice a day applied to each eyebrow for 7 months. intervention 2: Vehicle to bimatoprost solution once or twice a day applied to each eyebrow for 7 months.

Protocol documents:
Clinical trial NCT00864253
Conditions: Malignant Melanoma
Keywords: Melanoma Malignant Abraxane ABI-007 Dacarbazine Dtic-Dome
Sponsor: Celgene
Start date: 2009-04-23; Completion date: 2014-02-12
Enrollment: 529 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this research study is to compare the safety, tolerability, and anti tumor activity of an investigational drug, ABI-007 versus Dacarbazine in patients with metastatic melanoma who have not previously received chemotherapy. ABI-007 is a new preparation of the active drug paclitaxel. It contains the same medication as the prescription chemotherapy drug Abraxane®. Abraxane® is approved by the FDA for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Dacarbazine is approved by the FDA for the treatment of melanoma. In this study, ABI-007 and Dacarbazine will be tested as therapy for people who have not yet had any cancer treatment for the diagnosis of metastatic melanoma.

Detailed description:

Arms: arm 1: Treatment Arm A (ABI-007): Patients who receive ABI-007 will be dosed intravenously over approximately 30 minutes without steroid pre-medication and without G-CSF prophylaxis (unless modified as described below). ABI-007 150 mg/m2 will be administered on Days 1, 8, and 15 every 4 weeks. arm 2: Treatment Arm B (dacarbazine): Patients who receive dacarbazine will be dosed intravenously at 1000 mg/m2 on Day 1 with steroid and antiemetic pre-medication. Treatment will be repeated every 21 days.
Interventions: intervention 1: ABI-007 intervention 2: Dacarbazine
Intervention descriptions: intervention 1: Patients who receive ABI-007 will be dosed intravenously over approximately 30 minutes without steroid pre-medication and without G-CSF prophylaxis (unless modified as described below). ABI-007 150 mg/m2 will be administered on Days 1, 8, and 15 every 4 weeks. intervention 2: Patients who receive dacarbazine will be dosed intravenously at 1000 mg/m2 on Day 1 with steroid and antiemetic pre-medication. Treatment will be repeated every 21 days.

Protocol documents:
Clinical trial NCT01104415
Conditions: Carcinoid Syndrome
Sponsor: Lexicon Pharmaceuticals
Start date: 2010-06-15; Completion date: 2014-02-12
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the safety and tolerability of orally administered telotristat etiprate (LX1606) in participants with symptomatic carcinoid syndrome.

Detailed description:

Arms: arm 1: Following a 2-week Run-In Period, participants received telotristat etiprate capsules at a starting dose of 150 mg, orally three times daily (TID) for 14 days in the Core Phase. Dose escalations (250 mg, 350 mg, 500 mg) occurred serially every 14 days, up to a maximum dosage of telotristat etiprate 500 mg TID, as guided by specific clinical criteria for dose escalation. Upon completion of 12 weeks of treatment, participants were eligible to receive telotristat etiprate in the optional Open-label Extension Period. arm 2: Participants received telotristat etiprate at their highest tolerated dose (250 mg or 500 mg), orally, TID for 124 weeks in the Open-label Extension Period. If neither dose was tolerated participants were discontinued from the study and completed the 2-week Follow-up Visit.
Interventions: intervention 1: Telotristat etiprate
Intervention descriptions: intervention 1: Telotristat etiprate capsules orally three times daily.

Protocol documents:
Clinical trial NCT01656434
Conditions: Contraception
Keywords: Combined Oral Contraceptives
Sponsor: Organon and Co
Start date: 2012-11-02; Completion date: 2014-02-12
Enrollment: 3173 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the contraceptive efficacy of a nomegestrol acetate + 17ß-estradiol (NOMAC-E2) combined oral contraceptive (COC) in healthy, sexually-active American women at risk for pregnancy. Vaginal bleeding patterns of women taking NOMAC-E2 were assessed and compared to those of women taking a norethisterone acetate + ethinyl estradiol (NETA-EE) COC. The safety of NOMAC-E2 was also assessed.

Participants were randomized to receive either NOMAC-E2 or NETA-EE in a 3:1 ratio. As of Amendment 1 (which increased the sample size of the NOMAC-E2 group), the randomization ratio was adapted accordingly for participants randomized after the sample size increase.

Detailed description:
This study was terminated early. The decision to terminate the study was based upon difficulties encountered with data collection (related to incomplete e-Diary entries) in concert with business considerations. The decision was not related to any new or unexpected safety or efficacy findings with NOMAC-E2. As a result of this early termination, none of the pre-specified efficacy endpoints were analyzed.

Arms: arm 1: Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28. arm 2: Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
Interventions: intervention 1: NOMAC-E2 intervention 2: NETA-EE intervention 3: Placebo intervention 4: ethinylestradiol (EE) intervention 5: ferrous fumarate
Intervention descriptions: intervention 1: NOMAC-E2 film-coated oral tablets containing 2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol. intervention 2: NETA-EE film-coated oral tablets containing 1 mg norethisterone acetate and 10 μg ethinylestradiol. intervention 3: tablet intervention 4: EE 10 μg tablet intervention 5: ferrous fumarate 75 mg tablet

Protocol documents:
Clinical trial NCT01288430
Conditions: Solid Tumors Non-small Cell Lung Carcinoma
Keywords: Heat shock protein 90 Advanced solid tumors Non-small cell lung carcinoma Epidermal growth factor receptor Tyrosine kinase inhibitor acquired resistance Non-small cell lung carcinoma with acquired resistance to erlotinib, gefitinib, afatinib or others.
Sponsor: Daiichi Sankyo
Start date: 2011-03-29; Completion date: 2014-02-13
Enrollment: 60 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This phase 1 clinical trial is intended to understand the safety and tolerability of a new anticancer drug in subjects with advanced solid tumors. The patients who qualify for the study will receive a once daily dose of the drug taken by mouth and will undergo several tests to measure the drug in the blood and to understand the safety, tolerability and any effect of the drug on the tumor. The antitumor effect of the drug is not known in human.

Detailed description:
The study will be conducted in two parts. Part 1 is a dose escalation study in which subjects in each cohort will be given increasing doses of the study drug until a maximum tolerated dose (MTD) or maximum administered dose (MAD) is determined as the recommended phase 2 dose (RP2D). The drug will be administered as oral capsules once daily in 21 day cycles, with no interruption between cycles if no unacceptable treatment-related toxicity or tumor progression are observed.

After determining the RP2D, Part 2 of the study, which is a dose expansion study will begin in which subjects with advanced non-small cell lung cancer who developed acquired resistance to epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKI), erlotinib, gefitinib, afatinib (and others) or whose tumors carry an ALK translocation and are resistant to ALK inhibitor therapy, will be treated with DS-2248 at RP2D. The drug will be administered as oral capsules once daily in 21 day cycles, with no interruption between cycles if no unacceptable treatment-related toxicity or tumor progression are observed.

Arms: arm 1: Study Part 1: DS-2248 oral capsule(s) of increasing strength in a dose escalation study in subjects with advanced solid tumors, administered once daily in 21-day cycles, with no interruption between cycles if no unacceptable treatment-related toxicity or tumor progression is observed.

Study Part 2: DS-2248 oral capsule(s) dose of 4.5 mg/m\^2, in subjects with non-small cell lung cancer who have developed acquired resistance to epidermal growth factor receptor-tyrosine kinase inhibitors or whose tumors carry an ALK translocation and are resistant to ALK inhibitor therapy, administered once daily in 21 day-cycles, with no interruption between cycles if no unacceptable treatment-related toxicity or tumor progression are observed.
Interventions: intervention 1: DS-2248
Intervention descriptions: intervention 1: Oral capsules, of various strengths (1, 5 , 20 ,or 50 milligrams), once daily during 21-day cycles, until unacceptable treatment-related toxicity or tumor progression are observed.

Protocol documents:
Clinical trial NCT01901302
Conditions: Opioid-Induced Constipation
Keywords: Opioid Constipation Chronic Pain
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2013-05-20; Completion date: 2014-02-13
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer pain.

Detailed description:
This is a multicenter, double-blind, placebo-controlled, parallel-group study in participants with OIC taking opioid therapy for chronic non-cancer pain. Approximately 600 participants (300 participants per treatment group) with OIC will be randomized at approximately 75 study centers to receive either oral 0.25 mg CB-5945 BID or oral matching placebo BID for the 12-week double-blind treatment period, followed by a 4-week follow-up period. All randomized participants will be evaluated for clinical response for duration of their study participation. All participants will be followed for safety for 4 weeks after last dose of the study medication, regardless of when they discontinue study medication. The clinical study report for this study includes pooled results for studies 5945-OIC-12-02 (NCT01901302) 5945-OIC-12-03 (NCT01901328), and 5945-OIC-12-04 (NCT01901341).

Arms: arm 1: 0.25 milligrams (mg) CB-5945 administered orally twice daily (BID) for a 12-week treatment period arm 2: Placebo BID for a 12-week treatment period
Interventions: intervention 1: CB-5945 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: