ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01297335
Conditions: Hypertension
Keywords: intrathecal clonidine poorly controlled hypertension
Sponsor: The Center for Clinical Research, Winston-Salem, NC
Start date: 2011-02-01; Completion date: 2012-07-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the acute efficacy of intrathecal clonidine to reduce blood pressure in hypertensive subjects with poor blood pressure control and describe its effects on cardiovascular function.

Detailed description:
Hypertension occurs commonly, is associated with major morbidity and mortality, and responds poorly to current therapies in a small minority of compliant patients. The goal of this investigator-initiated study is to determine whether intrathecal administration of clonidine reduces blood pressure in hypertensive patients, focusing on a group who often achieve inadequate blood pressure control with multiple drug therapy.

After consent, pts will be screened and if qualified brought into center and intrathecal injection of clonidine given. Patients will be closely monitored for 4 hours, while data is collected.

Arms: arm 1: Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.
Interventions: intervention 1: clonidine
Intervention descriptions: intervention 1: Intrathecal Clonidine

Protocol documents:
Clinical trial NCT01303224
Conditions: Irritable Bowel Syndrome With Diarrhea
Keywords: Irritable Bowel Syndrome Colon, irritable Bowel disease
Sponsor: Menarini Group
Start date: 2010-10-01; Completion date: 2012-07-01
Enrollment: 565 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial aims at the evaluation of the efficacy and safety of the neurokinin type 2 receptor antagonist Ibodutant in improving IBS-D symptoms.

Detailed description:
The study evaluates the efficacy and safety of three doses of ibodutant, given once daily for 8 weeks versus placebo in IBS-D patients. Efficacy is evaluated in terms of overall symptom relief and abdominal pain/discomfort relief after 8 weeks of treatment. The clinical phase of the study comprises a 2-week run-in period (treatment-free),an 8-week double-blind treatment period and a 2-week treatment withdrawal period, resulting in a 10-week overall duration of the study for each patient.

Patients report their IBS-related symptoms daily in an electronic diary (web-and telephone based)during all periods of the study.

Arms: arm 1: Oral tablet, to be given once daily in fasting conditions. arm 2: Oral tablet, to be given once daily in fasting conditions. arm 3: Oral tablet, to be given once daily in fasting conditions. arm 4: Oral tablet, to be given once daily in fasting conditions.
Interventions: intervention 1: Ibodutant intervention 2: Ibodutant intervention 3: Ibodutant intervention 4: Placebo
Intervention descriptions: intervention 1: Oral tablet, low dose, once daily, for 8 weeks intervention 2: Oral tablet, intermediate dose, once daily, for 8 weeks intervention 3: Oral tablet, high dose, once daily, for 8 weeks intervention 4: Oral tablet, (identical in appearance and weight to Ibodutant tablets), once daily, for 8 weeks

Protocol documents:
Clinical trial NCT01303406
Conditions: Friedreich's Ataxia
Keywords: randomized withdrawal idebenone friedreich's ataxia Miconos Patient reported outcome ICARS
Sponsor: Santhera Pharmaceuticals
Start date: 2011-04-01; Completion date: 2012-07-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study. The aim is to further investigate the effects of idebenone in patients with Friedreich's ataxia.

The objective of the PROTI study is to establish whether patients can correctly determine which treatment assignment (placebo or idebenone) they received during the randomised phase of the trial, and identify any potential changes on symptoms or activities.

Detailed description:

Arms: arm 1: Following the body weight, patients will be allocated to one of the following regimen:

Placebo Patients \< 45 kg - 3 tablets 3 times a day with meals

Placebo Patients \> 45 kg - 5 tablets 3 times a day with meals arm 2: Following the body weight, patients will be allocated to one of the following regimen:

Idebenone Patients \< 45 kg - 3 tablets 3 times a day with meals

Idebenone Patients \> 45 kg - 5 tablets 3 times a day with meals
Interventions: intervention 1: Idebenone intervention 2: Placebo
Intervention descriptions: intervention 1: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals). intervention 2: None

Protocol documents:
Clinical trial NCT01313663
Conditions: Lung Cancer, Small Cell
Keywords: GW786034 non-small cell lung cancer NSCLC pemetrexed pazopanib
Sponsor: GlaxoSmithKline
Start date: 2011-02-01; Completion date: 2012-07-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase II, randomized, open-label, multi-center study in advanced (Stage IVA and IVB subjects per the International Association for the Study of Lung Cancer (IASLC) 2009 Lung cancer staging schema) non-squamous NSCLC subjects comparing pazopanib relative to pemetrexed in the maintenance setting. Subjects should have completed 4-6 cycles of induction therapy with carboplatin + pemetrexed or cisplatin + pemetrexed and have had Stable Disease (SD), Partial Response (PR) or Complete Response (CR) as the best response to be enrolled into the study. The primary objective is to estimate the hazard ratio of progression free survival (PFS) in advanced NSCLC subjects given maintenance therapy of pazopanib (Arm A) relative to pemetrexed (Arm B). The secondary objectives are: overall survival, response rates, safety and tolerability. A total of approximately 200 subjects will be enrolled and randomized in a 1:1 ratio. Safety and efficacy assessments will be regularly performed on all subjects.

Detailed description:

Arms: arm 1: oral agent, administered at 800 mg daily (400 mg tablets x 2). Dose can be reduced, interrupted or discontinued due to adverse events or intolerance arm 2: pemetrexed IV 500 mg/m2 once every 3 weeks
Interventions: intervention 1: pazopanib intervention 2: pemetrexed
Intervention descriptions: intervention 1: oral agent, administered at 800 mg daily (400 mg tablets x 2). Dose can be reduced, interrupted or discontinued due to adverse events or intolerance intervention 2: pemetrexed IV 500 mg/m2 once every 3 weeks

Protocol documents:
Clinical trial NCT01318733
Conditions: Rosacea
Keywords: Rosacea
Sponsor: Galderma R&D
Start date: 2011-03-01; Completion date: 2012-07-01
Enrollment: 449 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5% once daily in subjects with moderate to severe facial erythema associated with rosacea.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: CD07805/47 gel 0.5%
Intervention descriptions: intervention 1: In this open-label study, all subjects will receive treatment with CD07805/47 gel 0.5% applied once daily, for up to 12 months.

Protocol documents:
Clinical trial NCT01328379
Conditions: Multiple Sclerosis
Sponsor: Acorda Therapeutics
Start date: 2011-03-01; Completion date: 2012-07-01
Enrollment: 430 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the safety and efficacy of a lower dose of dalfampridine extended release tablets compared to the currently approved dose in improving walking in Multiple Sclerosis (MS) patients.

Detailed description:
The current study is designed as a prospective placebo-controlled trial to investigate the safety and efficacy of a lower dose of dalfampridine extended release tablets (5 mg twice daily) compared to the approved commercial dose of 10 mg twice daily in improving walking in MS patients during a four-week period of treatment.

Arms: arm 1: 5mg, twice daily arm 2: 10mg, twice daily arm 3: placebo, twice daily
Interventions: intervention 1: Dalfampridine-ER 5mg intervention 2: Dalfampridine-ER 10mg intervention 3: Placebo
Intervention descriptions: intervention 1: 5mg, twice daily intervention 2: 10mg, twice daily intervention 3: placebo, twice daily

Protocol documents:
Clinical trial NCT01335789
Conditions: Marijuana Dependence
Keywords: marijuana substance abuse drug abuse marijuana dependence drug addiction
Sponsor: Medical University of South Carolina
Start date: 2011-03-01; Completion date: 2012-07-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate how people who frequently use marijuana respond to a stressful task, and if a medication (oxytocin) affects this response.

Detailed description:
Stress is commonly associated with drug craving and relapse in substance-dependent individuals. Several studies indicate that hypothalamic neuropeptides may mediate behavioral response to stress. For example, preclinical and clinical investigations have indicated that the neuropeptide oxytocin exerts anxiolytic effects in stress paradigms. Several studies have indicated that oxytocin promotes trust, social bonding, and calmness; however, little is known about the potential anxiolytic affects of oxytocin in marijuana-dependent individuals. A preclinical study investigating the effects and mechanism of lithium on cannabinoid withdrawal in rats had positive findings, with increasing oxytocin levels hypothesized to moderate this effect (Cui et al, 2001). Given the anxiolytic nature of oxytocin, it may have a therapeutic role in ameliorating the negative affect commonly observed prior to relapse in marijuana-dependent individuals, as well as the anxiety associated with marijuana withdrawal. This pilot protocol will provide important preliminary data on the effect of oxytocin on stress in marijuana-dependent individuals.

Arms: arm 1: intranasal administration arm 2: intranasal administration
Interventions: intervention 1: Oxytocin intervention 2: Saline
Intervention descriptions: intervention 1: 40 IUs intervention 2: 40 IUs

Protocol documents:
Clinical trial NCT01339299
Conditions: Controlled Ovarian Stimulation Infertility
Keywords: COS ART Infertility
Sponsor: Regionshospitalet Viborg, Skive
Start date: 2009-10-01; Completion date: 2012-07-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is a prospective, randomised, controlled, and non-blinded multi-center pilot study to evaluate endocrine efficacy of recombinant luteinizing hormone versus recombinant human chorionic gonadotropin administered during controlled ovarian stimulation for IVF/ICSI in normogonadotrophic women.

Detailed description:

Arms: arm 1: 150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14) arm 2: 25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )
Interventions: intervention 1: recombinant luteinizing hormone (r-LH) intervention 2: recombinant human chorionic gonadotropin (r-hCG)
Intervention descriptions: intervention 1: administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14) intervention 2: administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)

Protocol documents:
Clinical trial NCT01340651
Conditions: Myelofibrosis
Keywords: myelofibrosis myeloproliferative neoplasms PMF PET-MF PPV-MF
Sponsor: Incyte Corporation
Start date: 2011-03-01; Completion date: 2012-07-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety and tolerability of ruxolitinib (INCB018424) sustained release (SR) formulation in participants with primary myelofibrosis (PMF), post-polycythemia vera MF (PPV-MF), and post-essential thrombocythemia MF (PET-MF).

Detailed description:
The study will enroll approximately 40 participants with PMF, PPV-MF or PET-MF. Participants will take ruxolitinib SR once daily for 16 consecutive weeks and then transition to a comparable twice daily dose regimen of ruxolitinib using the immediate release (IR) tablets which have been under investigation in controlled Phase 1, 2, and 3 clinical trials.

Participants receiving benefit from treatment with ruxolitinib may continue further participation with IR tablets up to the time when the last participant completed Week 36 or the commercial availability of ruxolitinib IR, whichever was earlier. Follow-up will occur at least 30 days following the last dose of ruxolitinib.

Arms: arm 1: Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD. At Week 16, participants transitioned to ruxolitinib 10, 15, or 20 mg immediate release (IR) orally twice daily. Participants who continued to demonstrate benefit in the opinion of the investigator could remain on ruxolitinib IR until the last participant completed Week 36 or the commercial availability of ruxolitinib IR, whichever was earlier; the dose received was based on platelet counts at the time of transition.
Interventions: intervention 1: Ruxolitinib
Intervention descriptions: intervention 1: Ruxolitinib was supplied as SR and IR formulated tablets.

Protocol documents:
Clinical trial NCT01344460
Conditions: Renal Artery Obstruction
Keywords: magnetic resonance angiography (MRA) of the renal arteries
Sponsor: Bayer
Start date: 2011-05-01; Completion date: 2012-07-01
Enrollment: 317 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required.

This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA images taken without contrast agent using images from a CTA as the standard of reference, which may have been performed up to 60 days prior to enrolment. If a CTA has not been performed in this prior time period, a CTA is required for the study.

MRA and CTA images will be collected for an independent review (blinded read).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Gadobutrol (Gadovist, BAY86-4875)
Intervention descriptions: intervention 1: a single bolus injection of approx. 0.1mmol/kg

Protocol documents:
Clinical trial NCT01352507
Conditions: Erectile Dysfunction
Sponsor: Eli Lilly and Company
Start date: 2011-06-01; Completion date: 2012-07-01
Enrollment: 383 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to evaluate whether, after two 8-week treatment periods, male patients with erectile dysfunction (ED) in China prefer 20 milligram (mg) tadalafil or 100 mg sildenafil. This trial consists of two treatment periods of 8 weeks each and an extension phase of 8 weeks, for a total of 24 weeks.

Detailed description:

Arms: arm 1: 20 mg tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There is a washout period of 7-10 days between treatments.

At the end of the two 8-week treatment periods, participants will be allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED). arm 2: 100 mg sildenafil taken orally, as needed, for 8 weeks, followed by 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. There is a washout period of 7-10 days between treatments.

At the end of the two 8-week treatment periods, participants will be allowed to enter an 8-week extension phase on their preferred medication for ED.
Interventions: intervention 1: Tadalafil intervention 2: Sildenafil
Intervention descriptions: intervention 1: Administered Orally intervention 2: Administered Orally

Protocol documents:
Clinical trial NCT01353859
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2011-03-01; Completion date: 2012-07-01
Enrollment: 39 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This multicenter, open-label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with active rheumatoid arthritis who have an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for a total of 6 infusions plus methotrexate 10-25 mg orally weekly. Anticipated time on study treatment is 24 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: methotrexate
Intervention descriptions: intervention 1: 8 mg/kg iv every 4 weeks for a total of 6 infusions intervention 2: 10-25 mg orally weekly

Protocol documents:
Clinical trial NCT01364298
Conditions: Diabetic Peripheral Neuropathic Pain
Keywords: Gabapentin/B complex Pregabalin Pain Neuropathic Gavindo Lyrica
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2011-04-01; Completion date: 2012-07-01
Enrollment: 353 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, open-label, parallel, Phase 4 clinical trial to compare efficacy and safety of gabapentin/B-complex versus pregabalin in diabetic peripheral neuropathy pain (DPNP) management.

Detailed description:
Primary Objective:

To compare the efficacy of gabapentin/B-complex versus pregabalin administered for 12 weeks in the treatment of pain in mild to moderate diabetic peripheral neuropathy (DPN) of acute or chronic presentation.

Secondary Objectives:

To determine the safety and tolerability of gabapentin/B-complex versus pregabalin administered for 12 weeks in the treatment of pain in mild to moderate DPN of acute or chronic presentation.

Subjects will be randomized in a 1:1 ratio to receive gabapentin/B-complex or pregabalin.

The duration of treatment per subject will be 12 weeks.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Gabapentin/B-complex intervention 2: Pregabalin
Intervention descriptions: intervention 1: Gabapentin/B-complex (Gavindo®) tablet will be administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram \[mg\] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed will be 3600 mg/day. The total duration of treatment will be 84 days (12 weeks). intervention 2: Pregabalin (Lyrica®) capsule will be administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed will be 600 mg/day. The total duration of treatment will be 84 days (12 weeks).

Protocol documents:
Clinical trial NCT01370005
Conditions: Diabetes Mellitus, Type 2 Hypertension
Sponsor: Boehringer Ingelheim
Start date: 2011-06-01; Completion date: 2012-07-01
Enrollment: 825 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2 diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and blood pressure lowering effects of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly relevant, new information for the use of BI 10773

Detailed description:

Arms: arm 1: BI 10773 low dose once daily arm 2: BI 10773 high dose once daily arm 3: Placebo tablets matching BI 10773
Interventions: intervention 1: Placebo intervention 2: BI 10773 intervention 3: Placebo intervention 4: BI 10773 intervention 5: Placebo intervention 6: Placebo
Intervention descriptions: intervention 1: Placebo matching BI 10773 low dose intervention 2: BI 10773 high dose once daily intervention 3: Placebo matching BI 10773 low dose intervention 4: BI 10773 low dose once daily intervention 5: Placebo matching BI 10773 high dose intervention 6: Placebo matching BI 10773 high dose

Protocol documents:
Clinical trial NCT01370551
Conditions: Atrophic Vaginitis
Sponsor: Medinova AG
Start date: 2011-04-01; Completion date: 2012-07-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the long term safety and efficacy of the vaginal application of Gynoflor®, an extremely low dosed estrogen therapy with lactobacilli, on atrophic vaginitis in postmenopausal breast cancer patients who have been treated with aromatase inhibitors.

Detailed description:
Two center phase I pharmacokinetic study assessed circulating estrogens in breast cancer patients on a non-steroidal aromatase inhibitor (NSAI) with vaginal atrophy using vaginal ultra-low-dose 0.03 mg estriol (E3) and Lactobacillus combination vaginal tablets (Gynoflor). 16 women on nonsteroidal aromatase inhibitor with severe vaginal atrophy applied a daily vaginal tablet of Gynoflor for 28 days followed by a maintenance therapy of 3 tablets weekly for 8 weeks.

Arms: arm 1: Gynoflor vaginal tablets 1/day x 4 weeks, then 3/week for 8 weeks
Interventions: intervention 1: Estriol 0.03 mg, lyophylized lactobacillus
Intervention descriptions: intervention 1: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; Once daily for 28 days then 3 times per week for 8 weeks;

Protocol documents: