ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01582854
Conditions: Post-Stroke Cognitive Impairment (PSCI)
Keywords: Post-Stroke Cognitive Impairment (PSCI) Stroke Actovegin Cognition disorders
Sponsor: Takeda
Start date: 2012-06-01; Completion date: 2014-11-01
Enrollment: 503 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this trial is to provide evidence that Actovegin has a symptomatic effect in subjects with post stroke cognitive impairment (PSCI) during a six month treatment period compared to subjects administered placebo. Subjects received IV infusions whilst in hospital, and tablets once discharged. Subjects were followed up for a further six months after their treatment had been stopped to explore if the cognitive symptoms of the subjects treated with Actovegin showed sustained improvement. The trial also explored the possible prevention of dementia with Actovegin in patients who had suffered a recent ischaemic stroke, as well as the effect of Actovegin on other stroke outcomes. Safety information on Actovegin was collected.

Detailed description:
The drug tested in this study is called actovegin. Actovegin was tested to treat people who have post stroke cognitive impairment. This study looked at the improvement of cognitive symptoms in people who take actovegin compared to placebo.

The study enrolled 503 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:

* Actovegin-2000 mg intravenous solution; 2- 200 mg tablets 3 times a day
* Placebo intravenous solution; tablets (dummy inactive) - this is a solution or tablet that looks like the study drug but has no active ingredient

All participants received daily intravenous infusions in the hospital (up to a maximum of 20 infusions) followed by 2-200 mg tablets three times a day for the remainder of the 6-month treatment period.

This multi-centre trial was conducted in Belarus, Kazakhstan and Russia. The overall time to participate in this study was 12 months. Participants made multiple visits to the clinic plus a final visit after receiving their last dose of study drug for a follow-up assessment.

Arms: arm 1: Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months. arm 2: Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
Interventions: intervention 1: Actovegin intervention 2: Placebo
Intervention descriptions: intervention 1: Actovegin solution for infusion and Actovegin tablets intervention 2: Actovegin placebo-matching solution for infusion and Actovegin placebo-matching tablets

Protocol documents:
Clinical trial NCT01583543
Conditions: Ewing's Sarcoma
Keywords: Recurrent Metastatic
Sponsor: Massachusetts General Hospital
Start date: 2012-05-01; Completion date: 2014-11-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study is a Phase II clinical trial to test the efficacy of Olaparib in adult participants with recurrent/metastatic Ewing's Sarcoma following failure of prior chemotherapy.

Detailed description:
Primary Objectives Evaluate the objective response rate of olaparib in adult patients with recurrent and/or metastatic Ewing's sarcoma following failure of conventional chemotherapy.

Secondary Objectives To evaluate the progression-free survival, overall survival, and safety of olaparib in this patient population (ie Number of Participants With Adverse Events). As an exploratory objective, the investigators will evaluate (in subjects who agree to an optional biopsy) differences in pre- and post-treatment tumor DNA alterations and differences in levels of protein and RNA expression related to PARP inhibition.

Study Design Potential subjects who discuss and sign the informed consent form will undergo screening studies. Eligible patients will administer olaparib and obtain restaging imaging studies after 6 and 12 weeks on study, and then every 8 weeks thereafter. Participants will remain on study drug until disease progression, onset of unacceptable toxicities, or subject withdraws consent.

Arms: arm 1: 400mg PO BID Continuous
Interventions: intervention 1: Olaparib
Intervention descriptions: intervention 1: 400mg PO BID Continuous

Protocol documents:
Clinical trial NCT01585038
Conditions: Cardiovascular Disease
Keywords: endothelium inflammation oxidative stress HIV-1
Sponsor: Indiana University
Start date: 2012-07-01; Completion date: 2014-11-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the cardiovascular profiles of efavirenz and rilpivirine, which are two drugs used to treat HIV infection.

Detailed description:
This is a randomized, controlled, open-label, single-center study comparing the effects of efavirenz (EFV) versus rilpivirine (RPV) on endothelial function in a total of 40 HIV-uninfected healthy volunteers (20 in each arm) at the Indiana University Medical Center. Enrolled subjects will have their brachial artery flow-mediated dilation (FMD), a measure of endothelial function, and other cardiovascular, inflammatory, and oxidative stress parameters measured at baseline and again after 4 weeks of study treatment.

Arms: arm 1: Efavirenz 600mg given nightly without food for 30 days arm 2: Rilpivirine 25mg given daily with meals for 30 days
Interventions: intervention 1: Efavirenz intervention 2: Rilpivirine
Intervention descriptions: intervention 1: 600mg orally every evening intervention 2: 25mg orally once daily

Protocol documents:
Clinical trial NCT01609062
Conditions: Mucopolysaccharidosis IVA Morquio A Syndrome MPS IVA
Keywords: Mucopolysaccharidosis IVA Type A MPS IVA Type A Mucopolysaccharidosis IVA MPS IVA Morquio A Syndrome Lysosomal Storage Disorder LSD N-acetylgalactosamine-6-sulfatase N-acetylgalactosamine-6-sulfate sulfatase galactose-6-sulfatase GALNS enzyme replacement therapy ERT MOR-008 CPET MST muscle strength test physiological effect
Sponsor: BioMarin Pharmaceutical
Start date: 2012-04-01; Completion date: 2014-11-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to evaluate the safety of a 2.0 mg/kg/week and a 4.0 mg/kg/week of BMN 110 in patients with Morquio A syndrome for up to 196 weeks. Secondary objectives were to investigate the effect of the two doses on exercise capacity for up to 196 weeks. In addition, the pharmacokinetic (PK) parameters of both doses of BMN 110 was assessed.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: BMN 110 intervention 2: BMN 110
Intervention descriptions: intervention 1: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for up to 192 weeks. intervention 2: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion for 27 weeks, and will eventually transition to 2.0 mg/kg/week for up to an additional 166 weeks.

Protocol documents:
Clinical trial NCT01612858
Conditions: Lipodystrophy HIV Infection
Keywords: Lipodystrophy Insulin resistance HIV infection
Sponsor: Tufts Medical Center
Start date: 2011-06-01; Completion date: 2014-11-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the relationship between insulin resistance and changes in body fat distribution in HIV-infected persons. This study measures insulin sensitivity, abdominal fat, and intramuscular fat in HIV-infected persons and examines the effect of an anti-diabetic drug (metformin or pioglitazone) on insulin sensitivity and body fat in this population.

Detailed description:
Although HIV antiretroviral medications have helped patients live longer, they have also been associated with side effects including insulin resistance and changes in body fat distribution. Changes in body fat distribution associated with HIV antiretroviral medications may result in increased fat in the abdomen, neck, and upper back, which is often called central fat deposition. HIV antiretroviral medications may also result in loss of fat in legs, arms, and face, which is often called peripheral fat atrophy.

This study will obtain preliminary data on the effect of 12 weeks of metformin on insulin sensitivity and hepatic and peripheral muscle fat in HIV-infected persons with insulin resistance and central fat deposition. Similarly, this study will obtain preliminary data on the effect of 12 weeks of pioglitazone on insulin sensitivity and hepatic and peripheral muscle fat in HIV-infected persons with insulin resistance and peripheral fat atrophy.

This study involves taking a drug that has been approved by the U.S. Food and Drug Administration (FDA) for use in humans for a period of 3 months.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Metformin intervention 2: Pioglitazone
Intervention descriptions: intervention 1: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study. intervention 2: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.

Protocol documents:
Clinical trial NCT01636778
Conditions: Hepatitis C, Chronic
Keywords: Thrombocytopenia Hepatitis C, chronic
Sponsor: GlaxoSmithKline
Start date: 2012-07-01; Completion date: 2014-11-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the ability of SB-497115-GR to raise platelet counts in thrombocytopenic patients with hepatitis C virus (HCV) infection (platelet count \<80,000 /μL, suggestive of compensated cirrhosis) to a level desirable to initiate antiviral therapy and to assess the ability of SB-497115-GR to maintain platelet counts at a level sufficient to minimise dose reductions of pegylated interferon (Peg-IFN) and ribavirin (RBV) therapy with the expectation that a lower rate of Peg-IFN dose reduction and omission will translate to a higher rate of sustained viral response.

Detailed description:

Arms: arm 1: investigational product for thrombocytopenia
Interventions: intervention 1: SB-497115-GR
Intervention descriptions: intervention 1: TPO receptor agonist to increase platelet count

Protocol documents:
Clinical trial NCT01642615
Conditions: Gastroesophageal Reflux Disease Erosive Esophagitis
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2012-07-01; Completion date: 2014-11-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and effectiveness of treatment with once daily oral administration of dexlansoprazole delayed-release capsules in adolescents with erosive esophagitis (EE) and for maintenance of healed EE and relief of heartburn.

Detailed description:
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to treat adolescents who have erosive esophagitis and heartburn and maintenance of healing of EE.

The study planned to enroll approximately 60 patients.

The study consisted of 3 periods:

1. Screening ((21 \[+5\] days)
2. Treatment (8 weeks for healing, 16 weeks for maintenance),
3. Post-Treatment Follow-up (up to 3 months).

During screening, participants used an electronic diary (eDiary) daily to document the presence of daytime and nighttime heartburn symptoms and the degree to which heartburn hurt (hereinafter referred to as severity), and to record their use of rescue medication (antacid).

During the first 8 week treatment period, all participants received dexlansoprazole 60 mg, once daily (QD). At the Week 8 visit, participants underwent endoscopy to assess healing of EE. Participants whose EE had not healed were discontinued from the study.

Participants whose EE had healed were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* dexlansoprazole 30 mg QD
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient

All participants were asked to take one tablet each morning without regard to food throughout the study. Throughout both phases of the Treatment Period, all participants continued to use the eDiary to document the presence or absence and severity of daytime and nighttime heartburn symptoms and the use of rescue medication.

This multi-center trial was conducted worldwide. The overall time to participate in this study was 39 weeks. Participants made multiple visits to the clinic, and were contacted by telephone during the study

Arms: arm 1: Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks. arm 2: Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks. arm 3: Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
Interventions: intervention 1: Dexlansoprazole intervention 2: Dexlansoprazole intervention 3: Placebo
Intervention descriptions: intervention 1: Dexlansoprazole capsules intervention 2: Dexlansoprazole capsules intervention 3: Dexlansoprazole placebo-matching capsules

Protocol documents:
Clinical trial NCT01683409
Conditions: Diabetic Kidney Disease
Sponsor: Eli Lilly and Company
Start date: 2012-08-01; Completion date: 2014-11-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a dose ranging study to evaluate the safety and efficacy of baricitinib in the treatment of participants with mild to moderate diabetic kidney disease.

Detailed description:

Arms: arm 1: Administered orally, given as three placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. arm 2: Administered orally, 0.75 mg given as one 0.75 mg tablets and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks or 0.5 mg given as one 0.5 mg tablet and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind. arm 3: Administered orally, 0.75 mg given as one 0.75 tablet and 2 placebo in the morning and one 0.75 mg tablet in the evening for 24 weeks or 0.5 mg given as one 0.5 mg tablet and two placebo tablets in the morning and one 0.5 mg tablet in the evening. Placebo tablets given to maintain blind. arm 4: Administered orally, 1.5 mg given as two 0.75 mg tablets and 1 placebo tablet in the morning and one placebo tablet in the evening for 24 weeks or 1 mg tablet and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind. arm 5: Administered orally, 4 mg given as one tablet and 2 placebo tablets in the morning and one placebo tablet in the evening for 24 weeks or 2.75 mg given as two 1 mg tablets and one 0.75 mg tablet in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.
Interventions: intervention 1: Baricitinib intervention 2: Placebo
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT01684930
Conditions: Peripheral Arterial Disease
Keywords: Cardiovascular Diseases Vascular Diseases Arterial Occlusive Diseases Exercise Functional Capacity
Sponsor: Duke University
Start date: 2012-06-01; Completion date: 2014-11-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The hypothesis of this proposal is that in subjects with PAD, regular consumption of a high nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of supervised exercise training at the limb ischemic threshold (SET) will produce a greater clinical benefit (increases in COT and PWT) than placebo plus supervised exercise at the limb ischemic threshold (PET).

Detailed description:

Arms: arm 1: Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 \& 2) and at the end of the trial (between Visits 3 \& 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 \& 3) to when the subject has not consumed the beverage (Visits 1 \& 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 \& 3 and for all supervised exercise training visits during the 12 week intervention. arm 2: Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 \& 2) and at the end of the trial (between Visits 3 \& 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 \& 3) to when the subject has not consumed the beverage (Visits 1 \& 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 \& 3 and for all supervised exercise training visits during the 12 week intervention.
Interventions: intervention 1: Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training intervention 2: Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training
Intervention descriptions: intervention 1: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training. intervention 2: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training.

Protocol documents:
Clinical trial NCT01697696
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, NVA237, QAB149, glycopyrronium bromide
Sponsor: Novartis Pharmaceuticals
Start date: 2012-10-01; Completion date: 2014-11-01
Enrollment: 511 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to provide long term safety data of NVA237. This study will assess the safety and tolerability of a single dose strength of NVA237.

Detailed description:

Arms: arm 1: NVA237 dose 1 arm 2: QAB149
Interventions: intervention 1: NVA237 intervention 2: Long-acting beta 2-agonist (LABA) intervention 3: Placebo
Intervention descriptions: intervention 1: NVA237 will be supplied in capsule form in blister packs for use in the Novartis Concept 1 SDDPI intervention 2: QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept 1 SDDPI intervention 3: Placebo to match QAB149

Protocol documents:
Clinical trial NCT01706575
Conditions: Hepatitis B, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2013-01-01; Completion date: 2014-11-01
Enrollment: 76 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single-arm, multicenter study will evaluate the efficacy and safety of adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (NAs) treatment in participants with HBeAg-negative chronic hepatitis B genotype D showing stable HBV DNA suppression. After a 12-week Lead-in period on treatment with NA, participants with a HBsAg decline \<0.5 log10 IU/ml will enter the Add-on period to receive Pegasys 180 mcg subcutaneously weekly for 48 weeks in addition to their current NA treatment. Follow-up will be a further 48 weeks, during which the participants will continue their NA treatment.

Detailed description:

Arms: arm 1: Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than \<0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
Interventions: intervention 1: Pegylated Interferon (Peginterferon) Alfa-2a intervention 2: Nucleos(t)ide Analogues (NA)
Intervention descriptions: intervention 1: Peginterferon alfa-2a 180 mcg, subcutaneously (SC) once weekly for 48 weeks. intervention 2: Nucleos(t)ide analogues includes adefovir, entecavir, lamivudine or tenofovir.

Protocol documents:
Clinical trial NCT01723384
Conditions: Methamphetamine Alcohol
Keywords: methamphetamine alcohol HIV sexual behavior
Sponsor: University of California, San Francisco
Start date: 2013-05-01; Completion date: 2014-11-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Naltrexone, a µ-opioid receptor antagonist, is a promising agent for methamphetamine-using and binge-drinking men who have sex with men (MSM). Naltrexone has shown efficacy in reducing relapse to amphetamines and is FDA-approved for alcohol dependence. Oral naltrexone is inexpensive and has few toxicities but the standard daily regimen for naltrexone is problematic as patients forget to take the medication. Given the challenges in daily dosing, alternate regimen schedules have been proposed to increase efficacy and expand the population that may benefit from this pharmacologic agent. One approach is intermittent targeted administration of naltrexone, whereby individuals take the medication as-needed in anticipation of substance use or during periods of craving. Administration of naltrexone prior to exposure to amphetamines significantly attenuates craving and targeted naltrexone has shown efficacy in reducing heavy alcohol use. However, there have been no studies assessing intermittent targeted dosing of naltrexone among methamphetamine-using and binge-drinking MSM. Polysubstance use patterns are common among MSM, and studies among those who abuse more than one substance are urgently needed. The aims of this study are to determine whether targeted dosing of naltrexone is feasible, tolerable and acceptable among non-dependent methamphetamine-using and binge-drinking MSM.

Detailed description:

Arms: arm 1: Intermittent oral naltrexone to be taken on an as-needed basis for 8 weeks. arm 2: Intermittent oral placebo to be taken on an as-needed basis for 8 weeks
Interventions: intervention 1: Intermittent Oral Naltrexone intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01729819
Conditions: Overactive Bladder
Sponsor: Ferring Pharmaceuticals
Start date: 2013-01-01; Completion date: 2014-11-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the trial is to investigate the efficacy of combining tolterodine and desmopressin compared with tolterodine monotherapy in the treatment of women with overactive bladder with nocturia in terms of reduction of nocturnal voids during 3 months of treatment

Detailed description:

Arms: arm 1: Tolterodine tartrate extended release capsules + Desmopressin orally disintegrating tablets arm 2: Tolterodine tartrate extended release capsules + Placebo orally disintegrating tablets
Interventions: intervention 1: Tolterodine tartrate extended release capsules intervention 2: Desmopressin orally disintegrating tablets intervention 3: Placebo orally disintegrating tablets
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents: