ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01084655
Conditions: Prostate Cancer
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2010-07-01; Completion date: 2016-03-01
Enrollment: 38 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multicenter, Phase 1/2 study of TAK-700 in combination with docetaxel and prednisone that will evaluate the safety and pharmacokinetics (PK) of the combination and will allow estimation of prostate-specific antigen (PSA) response in men with metastatic castration-resistant prostate cancer (mCRPC).

Detailed description:

Arms: arm 1: Orteronel (TAK-700) 200 milligram (mg), tablets, orally, twice daily (BID) starting from Day 1 along with docetaxel 75 milligram per square meter (mg/m\^2), infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets , orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods. arm 2: Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Day 1 along with docetaxel 75 mg/m\^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets , orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods. arm 3: Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Cycle 1 Day 15 along with docetaxel 75 mg/m\^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 1 up to Day 21 of each 21-day treatment cycle until disease progression or end of treatment (EOT).
Interventions: intervention 1: TAK-700 intervention 2: Docetaxel intervention 3: Prednisone
Intervention descriptions: intervention 1: TAK-700 with docetaxel and prednisone on a continuous schedule. intervention 2: TAK-700 with docetaxel and prednisone on a continuous schedule. intervention 3: TAK-700 with docetaxel and prednisone on a continuous schedule.

Protocol documents:
Clinical trial NCT01228175
Conditions: Smoking Addiction
Sponsor: The Mind Research Network
Start date: 2010-03-01; Completion date: 2016-03-01
Enrollment: 218 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the effectiveness of smoking cessation using Varenicline versus placebo. Effectiveness will be measured by the average number of cigarettes smoked per smoking day for up to 36 weeks.

Detailed description:

Arms: arm 1: Varenicline arm 2: Microcrystal cellulose placebo
Interventions: intervention 1: Placebo intervention 2: Varenicline
Intervention descriptions: intervention 1: 25mg look alike riboflavin tablets to match active study medication. intervention 2: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily

Protocol documents:
Clinical trial NCT01230593
Conditions: Chalazion Unspecified Eye, Unspecified Eyelid Chalazion Left Eye, Unspecified Eyelid Chalazion Right Eye, Unspecified Eyelid Chalazion Both Eyes
Sponsor: McMaster University
Start date: 2010-11-01; Completion date: 2016-03-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
An eyelid stye, or chalazion, is the most common eyelid ailment, and is caused by the blockage of one of the oil secreting glands of the eyelid (meibomian glands). This leads to a typically painful, swollen, and red eyelid bump that lasts from days to weeks and months. The chalazion may cause tearing, pressure on the cornea, and irritation, all of which contribute to its morbidity. There are many anecdotal first line treatments for this condition, including warm compresses to the eyelid, topical antibiotics, topical steroids, topical combination antibiotic/steroid, and oral antibiotics. There have been no clinical trials to compare the efficacy of any of these conservative treatments. We wish to determine the most effective conservative medical treatment for chalazia.

Detailed description:

Arms: arm 1: "Hot Compress" arm 2: "Hot Compress", "Tobrex Drops", "Tobrex Ointment" arm 3: "Hot Compress", "Tobradex Drops", "Tobradex Ointment"
Interventions: intervention 1: Hot Compress plus Tobramycin Drops and Ointment intervention 2: Hot compress plus Tobramycin/Dexamethasone Drops and Ointment intervention 3: Hot Compresses
Intervention descriptions: intervention 1: In addition to hot compress, Tobramycin drops will be given to the affected eye 3x/day, and Tobramycin ointment will be given at night before bed. intervention 2: In addition to hot compress, Tobramycin/Dexamethasone drops will be given to the affected eye 3x/day, and Tobramycin/Dexamethasone ointment will be given at night before bed. intervention 3: Hot compresses 3x/day to eyelids

Protocol documents:
Clinical trial NCT01308814
Conditions: Perimenopause Menopause Depression
Keywords: Perimenopause Menopause Depression Cardiovascular health
Sponsor: University of North Carolina, Chapel Hill
Start date: 2010-10-01; Completion date: 2016-03-01
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study Background and Objectives: In the U.S. the majority of heart disease deaths are in women, not men. Much of the gender disparity in CVD rates relate to the burden of CV risk in women after the menopause. Depression has been associated with an increased risk for CVD morbidity and mortality. Even histories of recurrent depression in euthymic individuals are associated with elevated CV risk. Understanding the depression-CVD link may have particular relevance for women since women experience depression at a rate twice that of men. Substantial convergent evidence indicates that ovarian failure (estrogen deprivation) is one likely mechanism contributing to both CVD and depression in women. The perimenopause, a time associated with a two-fold increase in rates of depression, may provide an ideal opportunity for studying the pathophysiology of CV risk and depression in women.

The primary objective of this study is to examine the prophylactic role of estradiol in the development of depressive symptoms and the progression of cardiovascular risk in perimenopausal women with or without histories of depression. The investigators predict that women susceptible to depression will be particularly vulnerable to the acceleration of CVD in the context of the perimenopause and, consequently, will show differentially greater benefit of estradiol treatment during the menopause transition for both indices of CV risk (e.g. inflammation, endothelial function, stress reactivity), as well as depressive symptoms.

Detailed description:

Arms: arm 1: Placebo patches for 12 months and placebo pills for 12 days every 2 months. arm 2: Transdermal 17β-estradiol (100 ug/day) for 12 months and oral micronized progesterone (200 mg/day) for 12 days every two months.
Interventions: intervention 1: Estradiol intervention 2: Placebo
Intervention descriptions: intervention 1: Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered. intervention 2: Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months.

Protocol documents:
Clinical trial NCT01354314
Conditions: HIV Associated Neurocognitive Disorder
Keywords: HIV Neurocognitive impairment Memory Dementia CSF marker Functional assessment MRS Magnetic resonance spectroscopy Arterial spin labeling SSRI
Sponsor: Johns Hopkins University
Start date: 2010-11-01; Completion date: 2016-03-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to see if paroxetine and fluconazole are safe and effective as a treatment for problems with memory, concentration, thinking, and judgment in people who are infected with HIV. Paroxetine is an antidepressant approved by the FDA to treat major depression. Fluconazole is an antifungal medication approved by the FDA to treat fungal infections.

Detailed description:
The study will be a 24 week double-blind, placebo-controlled 2x2 factorial design pilot Phase I/II study in 60 HIV+ individuals with HAND. Participants will be randomly assigned to one of four groups: 1) fluconazole 100 mg every 12 hours orally per day, 2) paroxetine 20mg every evening orally per day, 3) fluconazole 100mg every 12 hours orally per day and paroxetine 20mg every evening orally per day and 4) placebo.

Primary Aim: To obtain preliminary data to evaluate the efficacy of fluconazole and/or paroxetine to decrease CSF lipid and protein markers of oxidative stress \[CSF ceramide and (C18:0 levels) and 3-nitrosylated proteins\].

Secondary Aims:

i) To evaluate the safety and tolerability of fluconazole and/or paroxetine in HIV+ individuals with HAND ii) To evaluate the effect of fluconazole and/or paroxetine on neurocognitive performance in HIV+ individuals with HAND iii) To evaluate the effect of fluconazole and/or paroxetine on functional performance in HIV+ individuals with HAND iv) To evaluate the CNS penetration of fluconazole and paroxetine after 24 weeks of treatment v) To obtain preliminary data to evaluate the efficacy of fluconazole and/or paroxetine to improve abnormal imaging markers as measured by magnetic resonance spectroscopy (MRS) and arterial spin labeling

Arms: arm 1: Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine arm 2: Paroxetine 20 mg orally once per day; placebo in place of fluconazole arm 3: Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day arm 4: Placebo in place of both fluconazole and paroxetine
Interventions: intervention 1: Fluconazole intervention 2: Paroxetine intervention 3: Paroxetine and Fluconazole intervention 4: Placebo
Intervention descriptions: intervention 1: One 100 MG capsule taken twice daily, 12 hour dosing intervention 2: Two 10 MG capsules paroxetine once daily in the evening intervention 3: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening intervention 4: One capsule in the morning, three capsules in the evening

Protocol documents:
Clinical trial NCT01370408
Conditions: Chemotherapy-induced Nausea and Vomiting
Keywords: Autologous stem cell transplant BEAM Oral busulfan Cyclophosphamide Etoposide Carboplatin melphalan
Sponsor: Northside Hospital, Inc.
Start date: 2012-02-01; Completion date: 2016-03-01
Enrollment: 85 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30 minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy. On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given orally for 2 days following chemotherapy.

Detailed description:
In order to decrease this delayed CINV, the investigators have developed a unique schedule of antiemetics that takes advantage of palonosetron's long elimination half-life (40 hours). In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30 minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy. On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given orally for 2 days following chemotherapy. The investigators hypothesize that this antiemetic schedule will significantly reduce the delayed CINV compared to historical controls

Arms: arm 1: All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation

Prior to IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV on the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Interventions: intervention 1: Palonosetron intervention 2: ondansetron intervention 3: Dexamethasone
Intervention descriptions: intervention 1: Prior to IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO intervention 2: Prior to IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV intervention 3: Prior to IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV

Protocol documents:
Clinical trial NCT01469546
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: Squamous Cell Carcinoma of the Head and Neck
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2012-01-01; Completion date: 2016-03-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate a new agent Axitinib in the treatment of head and neck cancer.

This is a new drug that is given as a pill twice a day to treat cancer. This is one of the new, "smart" drugs. It binds to a protein on the surface of the cancer cell called VEGFR, and this way it slows down the growth of cancer cells and kills them. Head and neck cancer cells are known to carry this protein on their surface. Research in animals and in patients with other kinds of cancer showed that Axitinib can be effective at killing cancer cells, or stopping their growth, by this mechanism. It is generally a safe drug that is given by mouth. The investigators do not know, however, whether Axitinib is effective in head and neck cancer. This research study is being conducted to learn if Axitinib works in head and neck cancer, and also to learn to predict who would benefit from it. Four blood draws will be done to check special blood tests while the subjects are treated with Axitinib. These will be drawn at the same time as your routine labs, and there will not be additional sticks needed. A biopsy of the tumor before and after 1 month of treatment may be obtained to test how the cancer cells are responding to treatment. By testing these blood and tissue samples, the researchers will look at special tests (protein molecules) to try to determine what kind of head and neck patients would best respond to this drug. This is an open-label study, meaning that all subjects are on the active drug and there is no placebo (sugar pill).

Detailed description:

Arms: arm 1: A prospective, single-institution, single-arm phase II study of Axitinib in patients with unresectable recurrent and metastatic head and neck squamous cell carcinoma who have received no more than two prior lines of systemic therapy for recurrent or metastatic head and neck cancer.
Interventions: intervention 1: Axitinib (AG-013736)
Intervention descriptions: intervention 1: The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities. This will be followed by clinical and/or radiologic response assessment after 8 weeks and subsequently every 2 months until disease progression (defined per RECIST \[Response Evaluation Criteria In Solid Tumors\] criteria, or obvious progression on clinical or laryngoscopic/endoscopic exam) or intolerable toxicity (defined as below). During treatment on this protocol, all patients will be evaluated for safety. Correlative biomarker analysis will also be conducted.

Protocol documents:
Clinical trial NCT01474863
Conditions: Severe Sepsis Acute Lung Injury
Sponsor: Vanderbilt University
Start date: 2012-08-01; Completion date: 2016-03-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a randomized, double-blind, placebo-controlled, phase 2 study to evaluate biochemical, clinical, and safety effects of 2 doses of intravenous L-citrulline compared to placebo in patients with severe sepsis at risk for or with acute lung injury. The hypothesis is that intravenous L-citrulline will decreased the development or progression of acute lung injury in patients with severe sepsis compared to placebo.

Detailed description:

Arms: arm 1: Low Dose Citrulline arm 2: Placebo IV infusion arm 3: High Dose Citrulline
Interventions: intervention 1: High Dose Citrulline intervention 2: Placebo intervention 3: Low Dose Citrulline
Intervention descriptions: intervention 1: Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days intervention 2: D5W IV fluids at isovolumetric rate (about 15ml/hr) intervention 3: Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days.

Protocol documents:
Clinical trial NCT01505764
Conditions: Cancer Cachexia
Keywords: Cachexia
Sponsor: VA Office of Research and Development
Start date: 2012-06-01; Completion date: 2016-03-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Cancer is often coupled with a condition called cachexia. In this condition, individuals continue to lose weight and lean body mass, which means their muscles are getting smaller and weaker. Studies have shown that cancer patients who are losing weight often are responding poorly to chemotherapy, are at greater risk of infection and have a reduced life expectancy. Also, people may not want to eat. To date, there are no approved treatments available for this condition.

This study is going to study the benefits of the use of the study drug, Anamorelin hydrochloride (HCl) in treatment or prevention of cachexia associated with cancer. Studies done before with the study drug have shown that the drug can help the cachectic condition. The purpose of this research study is to evaluate the effectiveness of Anamorelin HCl compared to placebo on body composition (amount of cell mass, fat, muscle, etc.) including measurements of body potassium and nitrogen stores.

In addition to the above, the study will also assess the effect of the study drug on handgrip strength, body weight, lean muscle mass, quality of life, appetite \& food intake, certain blood markers, energy expenditure (the amount of energy participants burn), functional performance, safety and tolerability of Anamorelin HCl.

Detailed description:
Subjects enrolled in the study will be randomly chosen to receive either Anamorelin HCL at a dose of 100 mg per day for 12 weeks or matching placebo. The chances of receiving anamorelin or placebo are 1 in 2. Which subject receives anamorelin or placebo will be decided at random. Neither the subject nor the study doctor will know which study drug the subject is receiving. The subject will be asked to visit the clinic at Day 1, Day 28, Day 56 and Day 84. There will also be a Day 112 follow-up visit and the medical records will be checked after that to see how the subjects are doing.

Arms: arm 1: Anamorelin HCl arm 2: Placebo
Interventions: intervention 1: Anamorelin HCl intervention 2: Placebo
Intervention descriptions: intervention 1: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day. intervention 2: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.

Protocol documents:
Clinical trial NCT01509586
Conditions: Smoking Smoking Cessation
Keywords: smoking smoking cessation Potentially Reduced Exposure Products (PREPs)
Sponsor: Medical University of South Carolina
Start date: 2011-11-01; Completion date: 2016-03-01
Enrollment: 1236 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This nationwide telephone and mail- based research study will recruit 1,400 cigarette smokers who are not motivated to quit to test the effects of a marketed oral, non-combustible smokeless tobacco product on cigarette smoking behaviors. It will also track the participants' usage patterns of the smokeless tobacco product.

Half of the participants will receive a new, potentially safer tobacco product during the first six weeks of the study, and half will not. During this six-week period, each participant will complete three brief phone interviews. After this first six week period, participants will complete 6 other brief follow-up interviews, where they will answer questionnaires about their smoking habits.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product
Intervention descriptions: intervention 1: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.

Protocol documents: