ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00717093
Conditions: Tobacco Use Cessation
Sponsor: Pfizer
Start date: 2008-08-01; Completion date: 2009-07-01
Enrollment: 432 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary goal of this study is to compare efficacy of varenicline to placebo for cessation of use of smokeless tobacco.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Varenicline Tartrate intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period. intervention 2: Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.

Protocol documents:
Clinical trial NCT00723021
Conditions: Asthma
Keywords: Bronchodilator
Sponsor: Pfizer
Start date: 2008-07-01; Completion date: 2009-07-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in patients with asthma

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: PF-04191834 intervention 2: PF-04191834 intervention 3: PF-04191834 intervention 4: zileuton intervention 5: Placebo
Intervention descriptions: intervention 1: 30mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets. intervention 2: 100mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets, single dose. intervention 3: 2000mg PF-04191834, single dose, oral dispersion + 2 x placebo tables, single dose intervention 4: 1200mg, 2 x 600mg tablets, single dose + placebo oral dispersion, single dose. intervention 5: 2 x placebo tablets + placebo oral dispersion, single dose.

Protocol documents:
Clinical trial NCT00723606
Conditions: Schizophrenia
Keywords: Intramuscular ziprasidone, agitation, efficacy and safety
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2008-09-01; Completion date: 2009-07-01
Enrollment: 376 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This local registration study is to confirm the hypothesis of the efficacy, tolerability and safety of ziprasidone IM (intramuscular) in the Chinese population with agitation in schizophrenia

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Intramuscular ziprasidone mesylate intervention 2: Intramuscular haloperidol
Intervention descriptions: intervention 1: The recommended dose is 10 to 20 mg administered as required up to a maximum dose of 40 mg per day. Doses of 10 mg may be administered every two hours; doses of 20 mg may be administered every four hours up to a maximum of 40 mg/day for 3 days. intervention 2: The haloperidol group will receive an initial intramuscular injection of haloperidol 5mg, following on which 5mg haloperidol may be repeated every 4-8 hours to a maximum of 20 mg /day for 3 days.

Protocol documents:
Clinical trial NCT00724815
Conditions: Migraine Disorders
Sponsor: NuPathe Inc.
Start date: 2009-01-01; Completion date: 2009-07-01
Enrollment: 530 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was a randomized, parallel group, double-blind, placebo controlled design to compare the efficacy and tolerability of NP101 to a placebo iontophoretic transdermal patch. The primary objective of this study was to assess the proportion of subjects who were headache pain free at two hours after patch activation.

Key secondary objectives included:

1. The proportion of subjects who were nausea free at two hours after patch activation.
2. The proportion of subjects who were photophobia free at two hours after patch activation.
3. The proportion of subjects who were phonophobia free at two hours after patch activation.

Detailed description:
Subjects stayed in the study until they had treated one migraine headache with a study patch or two months after randomization, whichever occurred first. During a migraine headache, subjects rated their baseline headache pain severity in a Migraine Study Diary using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) and applied the study patch only if their score was 2 or 3 (i.e., qualifying migraine headache). In addition to headache pain severity, subjects also recorded the presence or absence of aura, nausea, phonophobia, and photophobia, as well as the location of their headache (unilateral or bilateral) and whether their headache increased with movement.

Arms: arm 1: NP101 - sumatriptan iontophoretic transdermal patch arm 2: Placebo iontophoretic transdermal patch
Interventions: intervention 1: NP101 - Sumatriptan iontophoretic transdermal patch intervention 2: Placebo
Intervention descriptions: intervention 1: Sumatriptan iontophoretic transdermal patch intervention 2: NP101 Placebo iontophoretic transdermal patch

Protocol documents:
Clinical trial NCT00729846
Conditions: Age Related Macular Degeneration Choroidal Neovascularization Macular Edema
Keywords: choroidal neovascularization macular degeneration macular edema intravitreal bevacizumab vegf verteporfin PDT
Sponsor: California Retina Consultants
Start date: 2006-05-01; Completion date: 2009-07-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate safety, visual acuity outcomes, persistence of choroidal neovascular leakage, and the number of treatments of combination intravitreal bevacizumab and verteporfin photodynamic therapy at standard or reduced fluence level in patients with subfoveal CNV due to age-related macular degeneration.

Detailed description:

Arms: arm 1: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence \[300mw/cm2\] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy. arm 2: Patients will receive combination verteporfin with photodynamic therapy at standard fluence \[600mw/cm2\] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.
Interventions: intervention 1: Bevacizumab intervention 2: verteporfin photodynamic therapy reduced fluence intervention 3: verteporfin photodynamic therapy standardfluence
Intervention descriptions: intervention 1: Patients will receive intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy. intervention 2: Patients will receive combination verteporfin photodynamic therapy with stand fluence \[600mW/cm2\]. intervention 3: Patients will receive combination verteporfin with photodynamic therapy at standard fluence \[600mw/cm2\].

Protocol documents:
Clinical trial NCT00731198
Conditions: ERCP Pancreatic Diseases Bile Duct Diseases
Keywords: ERCP Drotaverine hydrochloride Hyoscine-N-butylbromide
Sponsor: Changhai Hospital
Start date: 2008-08-01; Completion date: 2009-07-01
Enrollment: 650 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the present study was to evaluate the use of drotaverine hydrochloride versus hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP.

Detailed description:
ERCP is an important endoscopic technique in the diagnosis and treatment of pancreatic and biliary diseases. Duodenal peristalsis can make cannulation of the papilla and the necessary therapeutic procedures difficult. Intravenous hyoscine-N-butylbromide is often used during ERCP to inhibit duodenal motility and enhance cannulation in China. However, the pharmaceutical agent is occasionally associated with serious complications such as cardiovascular events or anaphylactic shock. Hyoscine-N-butylbromide may also affect the ocular, urinary, and salivary systems.

Drotaverine hydrochloride is an analogue of papaverine with smooth muscle relaxant properties. It is a non-anticholinergic antispasmodic, which selectively inhibits phosphodiesterase IV and is accompanied by a mild calcium channel-blocking effect. Adverse effects with drotaverine hydrochloride, such as hypotension, vertigo, nausea, and palpitation, are mostly mild. It can be supposed that intravenous drotaverine hydrochloride might be a feasible antimotility alternative to intravenous hyoscine-N-butylbromide in ERCP. But there is no clear evidence to recommend the use of drotaverine hydrochloride as an antispasmodic during ERCP.

The aim of the present study was to evaluate the use of drotaverine hydrochloride versus hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP. The effects of drotaverine hydrochloride on facilitative cannulation and its adverse effects were also compared to hyoscine-N-butylbromide.

Arms: arm 1: Drotaverine hydrochloride arm 2: Hyoscine-N-butylbromide
Interventions: intervention 1: Drotaverine hydrochloride intervention 2: Hyoscine-N-butylbromide
Intervention descriptions: intervention 1: Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP intervention 2: Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.

Protocol documents:
Clinical trial NCT00735462
Conditions: Genital Warts
Keywords: external genital warts perianal warts condylomata acuminata human papilloma virus HPV types 6 and 11
Sponsor: Graceway Pharmaceuticals, LLC
Start date: 2008-08-01; Completion date: 2009-07-01
Enrollment: 511 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether imiquimod creams are effective in treating external genital warts (EGW). The secondary objective of this study is to provide information on recurrence of EGW. Additionally the study will also look at any adverse events associated with the use of the creams.

External genital and perianal warts are caused by the infection of human papillomavirus or HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like small flesh-colored, pink, or red growths on or around the external skin of sex organs or perianal area. The warts may look similar to the small parts of a cauliflower or they may be very tiny and difficult to see. They often appear in clusters of three or four, and may grow and spread rapidly. They usually are not painful, although they may cause mild pain, bleeding, and itching.

Detailed description:

Arms: arm 1: 2.5% imiquimod cream applied daily to wart areas for up to 8 weeks arm 2: 3.75% imiquimod cream applied daily to wart areas for up to 8 weeks. arm 3: Placebo cream applied daily to wart areas for up to 8 weeks.
Interventions: intervention 1: 2.5% imiquimod cream intervention 2: 3.75% imiquimod cream intervention 3: Placebo cream
Intervention descriptions: intervention 1: 2.5% imiquimod cream applied daily to wart areas for up to 8 weeks. intervention 2: 3.75% imiquimod cream applied daily to wart areas for up to 8 weeks intervention 3: Placebo cream applied daily to wart areas for up to 8 weeks

Protocol documents:
Clinical trial NCT00739908
Conditions: Major Depressive Disorder
Keywords: MDD
Sponsor: CeNeRx BioPharma Inc.
Start date: 2008-09-01; Completion date: 2009-07-01
Enrollment: 285 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the efficacy of CX157 60 mg administered three times a day (180 mg daily dose) as compared to placebo in subjects with Major Depressive Disorder (MDD). Secondary objectives are to evaluate the safety and tolerability and steady state pharmacokinetic profile of CX157 in these subjects.

Detailed description:
This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group, multi-center study comparing the efficacy, safety and tolerability of CX157 60mg TID and placebo. This study will be conducted at approximately 12 investigative sites in the US.

Subjects with suspected Major Depressive Disorder (MDD) and experiencing a Major Depressive Episode (MDE) who the investigator wishes to consider for enrollment in the study and who provide written informed consent will initially be evaluated by the Inventory of Depressive Symptomatology 30 item -Self Report (IDS-SR30) administered via Interactive Voice Response System (IVRS). Subjects who meet the minimum score of 40 on the IDS-SR30 will proceed with the remaining study related assessments at the Screening visit. Those subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one to two week Screening period to confirm eligibility and to capture Screening data prior to Randomization. At the Randomization visit, all eligibility requirements will be reconfirmed. The subjects who meet all criteria will be randomized to study medication and enter into a six-week treatment period and a subsequent one week Follow-Up period. The total duration of participation for subjects who complete all phases of the study will be approximately 8-9 weeks. During the treatment period, clinic visits will occur at Week 1, Week 2, Week 4, and Week 6. A subsequent clinic visit will occur at the end of the one week Follow-Up period. The clinical site will contact the subjects via telephone at Weeks 3 and 5 to inquire about their wellbeing, query about adverse events and administer the suicidality scale.

Eligible subjects will be randomized (1:1) to receive:

* CX157 60mg three times a day (TID) for a total daily dose of 180 mg, or
* Placebo administered three times a day.

Subjects who discontinue from the study for any reason will not be replaced.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CX157 (TriRima) intervention 2: Placebo
Intervention descriptions: intervention 1: Six capsules administered three times a day for six weeks. intervention 2: Six capsules administered three times a day for six weeks.

Protocol documents:
Clinical trial NCT00740207
Conditions: Peripheral Arterial Occlusive Disease
Sponsor: Bracco Diagnostics, Inc
Start date: 2008-09-01; Completion date: 2009-07-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare ISOVUE-250 and VISIPAQUE 270 for motion artifact and pain following intraarterial injection for peripheral DSA.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: VISIPAQUE 270 intervention 2: Isovue 250
Intervention descriptions: intervention 1: VISIPAQUE 270 (Iodixanol Injection) is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution intervention 2: ISOVUE-250 (Iopamidol Injection) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution

Protocol documents:
Clinical trial NCT00744627
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder Anxiety Disorders Drug Therapy
Sponsor: Takeda
Start date: 2008-09-01; Completion date: 2009-07-01
Enrollment: 301 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of vortioxetine, once daily (QD), in adults with Generalized Anxiety Disorders.

Detailed description:
The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat anxiety in adults who have general anxiety disorder (GAD). This study looked at GAD relief in people who took vortioxetine.

The study enrolled 301 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

* Vortioxetine 5 mg
* Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but had no active ingredient.

All participants were asked to take one capsule at the same time each day throughout the study.

This multi-center trial was conducted in Europe. The overall time to participate in this study was up to 13 weeks. Participants made 7 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.

Arms: arm 1: Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks. arm 2: Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Interventions: intervention 1: Vortioxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Encapsulated vortioxetine immediate-release tablets. intervention 2: Vortioxetine placebo-matching capsules

Protocol documents:
Clinical trial NCT00748098
Conditions: Restless Legs Syndrome Restless Legs Syndrome (RLS)
Keywords: PSG Restless Legs Syndrome gabapentin enacarbil XP13512 GSK1838262 sleep disturbance RLS polysomnography
Sponsor: XenoPort, Inc.
Start date: 2008-10-01; Completion date: 2009-07-01
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release tablets in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance.

Detailed description:
Double-blind, multi-center, placebo-controlled, 2-period crossover study which assessed the efficacy and safety of gabapentin enacarbil (GEn; GSK1838262; XP13512) extended release tablets in adults with Restless Legs Syndrome (RLS)-associated sleep disturbance. One hundred thirty-six (136) adult subjects with RLS-associated sleep disturbance and periodic limb movements (PLM) were randomized from 23 centers in the United States. Subjects who met all eligibility criteria were randomized to receive a treatment sequence of GEn:placebo or placebo:GEn. Investigational product was taken with food at approximately 5pm. Investigational product was dosed as 600mg/day x3 days followed by 1200mg/day x25 days for each 4-week treatment period. There was a 1-week taper at 600mg after each treatment period followed by a 1-week washout between treatments. Polysomnography (PSG) was used to objectively evaluate changes in sleep and PLMs.

Arms: arm 1: GSK1838262 extended release tablets for Treatment Period 1 followed by Placebo for Treatment Period 2 arm 2: Placebo for Treatment Period 1 followed by GSK1838262 for Treatment Period 2
Interventions: intervention 1: GSK1838262 Extended Release Tablets intervention 2: Placebo
Intervention descriptions: intervention 1: GSK1838262 extended release tablets intervention 2: Placebo

Protocol documents:
Clinical trial NCT00748579
Conditions: Heart Failure
Sponsor: Cytokinetics
Start date: 2008-09-01; Completion date: 2009-07-01
Enrollment: 2 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose for this study (CY 1124) is to evaluate the effects of CK-1827452, a cardiac myosin activator, on myocardial systolic performance, myocardial oxygen consumption, and myocardial efficiency in patients with heart failure and to confirm that the unique preclinical pharmacological profile of CK- 1827452 is substantially the same in patients with heart failure.

Detailed description:

Arms: arm 1: 0.5 hour loading dose followed by 1.0 hour maintenance dose of CK-1827452 arm 2: ≤ 1.0 hour loading dose followed by 1.0 hour maintenance dose of CK-1827452
Interventions: intervention 1: CK-1827452 intervention 2: CK-1827452
Intervention descriptions: intervention 1: I.V. infusion for 0.5 hour at 54mg/hr followed by 1 hour at 21mg/hr intervention 2: I.V. infusion for ≤ 1 hour at 72mg/hr followed by 1 hour at 36mg/hr

Protocol documents:
Clinical trial NCT00752726
Conditions: Obesity Overweight
Keywords: overweight, orlistat, body composition
Sponsor: GlaxoSmithKline
Start date: 2008-09-01; Completion date: 2009-07-01
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if a 24 week weight loss program with orlistat 60 mg will produce greater changes in body composition compared to placebo.

Detailed description:
Large amounts of VAT (adipose tissue surrounding the viscera of the organs), is known to be associated with increased risk of heart disease and diabetes. Orlistat (tetrahydrolipstatin or THL) inhibits gastrointestinal lipase and reduces the absorption of dietary fat. The purpose of this study is to to determine if a 24 week weight loss program with orlistat 60 mg would produce greater changes in adipose tissue depots (specifically VAT) compared to placebo. This study will use the Echo MRI technology across multiple sites to measure total fat mass. EchoMRI is a non invasive method ideally suited for studies which track changes in human body composition over time, with measuring times of less than 3 minutes and no radiation exposure.

Arms: arm 1: Orlistat 60 milligram (mg) capsules to be consumed orally with each meal 3 times per day arm 2: Placebo to match Orlistat 60 mg capsules to be consumed orally with each meal 3 times per day.
Interventions: intervention 1: Orlistat intervention 2: Placebo
Intervention descriptions: intervention 1: Weight loss treatment intervention 2: Inactive

Protocol documents:
Clinical trial NCT00758589
Conditions: Asthma
Keywords: Asthma
Sponsor: AstraZeneca
Start date: 2008-09-01; Completion date: 2009-07-01
Enrollment: 368 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate efficacy of AZD1981 in uncontrolled asthmatic patients on maintenance inhaled glucocorticosteroids.

Detailed description:

Arms: arm 1: AZD1981 50 mg Twice Daily (Bid) arm 2: Placebo arm 3: AZD1981 400 mg Twice Daily (Bid) arm 4: AZD1981 1000 mg Twice Daily (Bid)
Interventions: intervention 1: AZD1981 intervention 2: AZD1981 intervention 3: AZD1981 intervention 4: Placebo
Intervention descriptions: intervention 1: Oral tablet, 50 mg twice daily intervention 2: Oral tablet, 400 mg twice daily intervention 3: Oral tablet, 1000 mg twice daily intervention 4: None

Protocol documents:
Clinical trial NCT00759941
Conditions: Glaucoma
Keywords: Glaucoma
Sponsor: Alcon Research
Start date: 2007-10-01; Completion date: 2009-07-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the efficacy of adding Azopt dosed three times a day to Xalatan as compared to that of adding placebo to Xalatan in patients with elevated intraocular pressure.

Detailed description:

Arms: arm 1: Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months. arm 2: Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
Interventions: intervention 1: Brinzolamide 1% ophthalmic solution (Azopt) intervention 2: Placebo eye drops intervention 3: Latanoprost 0.005% ophthalmic solution (Xalatan)
Intervention descriptions: intervention 1: One drop three times a day in both eyes for 3 months intervention 2: One drop three times a day in both eyes for 3 months intervention 3: One drop once a day in both eyes for 3 months

Protocol documents: