ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01709149
Conditions: Amyotrophic Lateral Sclerosis
Sponsor: Cytokinetics
Start date: 2012-10-01; Completion date: 2014-03-01
Enrollment: 711 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to evaluate the safety and effectiveness of CK-2017357 when taken with or without riluzole (also called Rilutek®) in patients with Amyotrophic Lateral Sclerosis (ALS).

Detailed description:
The length of the study, including screening, dosing, and follow-up, is approximately 20 weeks. After a one-week open-label phase during which all patients will receive CK-2017357 125 milligrams (mg) twice daily, patients who tolerate the open-label 125 mg of CK-2017357 will be randomized one to one (fifty-fifty) to receive double-blind CK-2017357 or matching placebo. The CK-2017357/placebo dose will be increased no faster than weekly to each patient's highest tolerated daily dose, with a maximum of 250 mg twice daily. The dose may be decreased based on tolerability. Patients will continue treatment at the highest tolerated dose to complete a total of 12 weeks of double-blind treatment. Patients may be on riluzole or not on riluzole at study entry. Patients not on riluzole must stay off riluzole. Patients on riluzole who are getting double-blind CK-2017357 will be given riluzole at half the labeled dosage (50 mg once a day instead of 50 mg twice a day). Blood tests for safety will be performed. Information about any side effects that may occur will also be collected.

Arms: arm 1: 125 mg tablets arm 2: Placebo tablets
Interventions: intervention 1: CK-2017357 intervention 2: Placebo tablets intervention 3: Riluzole
Intervention descriptions: intervention 1: CK-2017357 125 mg tablets twice daily intervention 2: Tablets intervention 3: Tablets

Protocol documents:
Clinical trial NCT01740154
Conditions: Fatigue Recurrent Renal Cell Cancer Stage IV Renal Cell Cancer
Sponsor: Case Comprehensive Cancer Center
Start date: 2012-09-01; Completion date: 2014-03-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to determine how sunitinib (sunitinib malate) causes fatigue. Patients will be asked to complete a brief questionnaire (survey) to rate their levels of fatigue every two weeks while they are participating in this research study. The questionnaire takes approximately 10-15 minutes to complete and is 9 questions. A series of physical measurements for fatigue will be performed before the first dose of sunitinib and again (4) weeks later to see if there are any changes in physical level of fatigues

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the mechanisms associated with sunitinib related fatigue by recording EMG signals during a submaximal elbow contraction, twitch force and TMS prior to and at the end of 4 weeks of sunitinib in metastatic RCC patients.

OUTLINE:

Patients receive sunitinib malate orally (PO) daily for 4 weeks. Patients undergo neuromuscular testing at baseline and on day 28 and complete fatigue assessment at baseline and on days 14 and 28.

.

Arms: arm 1: Patients receive sunitinib malate PO daily for 4 weeks. Patients undergo neuromuscular testing at baseline and on day 28 and complete fatigue assessment at baseline and on days 14 and 28.
Interventions: intervention 1: transcranial magnetic stimulation intervention 2: electromyography intervention 3: survey administration intervention 4: sunitinib malate
Intervention descriptions: intervention 1: Undergo TMS intervention 2: Undergo EMG intervention 3: Ancillary studies intervention 4: Given PO

Protocol documents:
Clinical trial NCT01766076
Conditions: Acquired Immune Deficiency Syndrome Virus
Keywords: immune activation antiretroviral therapy atorvastatin immune exhaustion adults Africa
Sponsor: Makerere University
Start date: 2013-01-01; Completion date: 2014-03-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
We hypothesise that atorvastatin changes immune activation among HAART-treated adults with suboptimal cluster cell differentiation 4 (CD4) recovery by 25%

Detailed description:
The investigators have previously shown that up to 40% of HAART-treated adults have suboptimal CD4 recovery despite viral suppression. The investigators have also shown that immune activation and exhaustion are significantly higher among patients that do not exhibit satisfactory rise in CD4 counts despite viral suppression (suboptimal responders); when compared with their counterparts with viral suppression and satifactory CD4 count recovery (optimal responders). Given that atorvastatin changes immune activation in this pilot study, then larger studies can be done to understand its effect on CD4 count increase among suboptimal responders.

Arms: arm 1: Intervention is be atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.

Peripheral blood mononuclear cells (PBMC) will be collected for immune activation assays using flowcytometry arm 2: Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry
Interventions: intervention 1: atorvastatin, Lipitor® intervention 2: Placebo
Intervention descriptions: intervention 1: PBMC collected for immune activation assays using flowcytometry intervention 2: PBMC collected for immune activation assays using flowcytometry

Protocol documents:
Clinical trial NCT01782222
Conditions: Idiopathic Parkinson's Disease
Keywords: Parkinson's Disease Rotigotine Apathy Nonmotor Motor Neupro
Sponsor: UCB BIOSCIENCES GmbH
Start date: 2013-02-01; Completion date: 2014-03-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is being conducted to assess the effects of Rotigotine over Placebo on improvement of Apathy and motor symptoms in subjects with early-stage and advanced stage idiopathic Parkinson´s Disease.

Detailed description:

Arms: arm 1: Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease arm 2: Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease arm 3: Placebo transdermal patches
Interventions: intervention 1: Rotigotine intervention 2: Placebo
Intervention descriptions: intervention 1: Rotigotine, transdermal patches:

10 cm\^2 (2 mg / 24 hours); 20 cm\^2 (4 mg / 24 hours); 30 cm\^2 (6 mg / 24 hours); 40 cm\^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed is 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation) intervention 2: Placebo, matching transdermal patches

Duration: up to 21 weeks (including de-escalation)

Protocol documents:
Clinical trial NCT01801280
Conditions: Transplantation Immunosuppression Drug Interaction
Keywords: immunosuppressive medication mycophenolic acid interaction proton pump inhibitor pantoprazole renal transplant patients pharmacokinetics pharmacodynamics bioavailability
Sponsor: Klemens Budde
Start date: 2012-01-01; Completion date: 2014-03-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this pharmacokinetic study is to examine a possible drug-drug interaction of Pantoprazole on the bioavailability mycophenolic acid.

Detailed description:
It is a randomized open-label 4-sequence 4-period pharmacokinetic cross-over study. The objective of the pharmacokinetic study is to examine a drug-drug interaction of pantoprazole on the bioavailability mycophenolic acid administered as either mycophenolate mofetil (Cellcept(R) or mycophenolate Sodium; EC-MPS (Myfortic (R) in stable renal allograft recipients under maintenance immunosuppressive therapy (cyclosporine +/- low dose glucocorticoids).

Arms: arm 1: Mycophenolate mofetil (C) b.i.d. every 12 hours for 2 weeks. arm 2: Mycophenolate mofetil b.i.d and Pantoprazole o.m. for 2 weeks. arm 3: Mycophenolate sodium (M) b.i.d. every 12 hours for 2 weeks. arm 4: Mycophenolate mofetil b.i.d and Pantoprazole 40mg o.m. for 2 weeks.
Interventions: intervention 1: Mycophenolate sodium intervention 2: Pantoprazole intervention 3: Mycophenolate mofetil
Intervention descriptions: intervention 1: Daily dose: 720mg, 1080mg, 1440mg. Application alone or together with Pantozol®. intervention 2: Daily dose: 40mg. Application together with CellCept® or Myfortic® . intervention 3: Daily dose: 1000mg, 1500mg, 2000mg. Application alone or with Pantozol® .

Protocol documents:
Clinical trial NCT01808339
Conditions: Asthma
Keywords: Fluticasone Furoate, FF Inhalation Powder, morning dosing, evening dosing, efficacy, FEV1
Sponsor: GlaxoSmithKline
Start date: 2013-03-01; Completion date: 2014-03-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will investigate the effects of altering the time of day of dosing (morning or evening) with Fluticasone Furoate 100 (FF 100) micrograms (mcg) once daily administered via a dry powder inhaler (DPI) in subjects with persistent bronchial asthma. This is a repeat-dose, double-blind, randomized, placebo-controlled, three-way crossover study to compare the effect of morning (AM) and evening (PM) dosing with FF 100 on lung function. Twenty-four male and female subjects with persistent bronchial asthma will be enrolled to ensure twenty evaluable subjects. The three treatments will be FF 100 AM (with placebo PM), FF 100 PM (with placebo AM) and matching placebo (AM and PM). All treatments will be administered for 14 (+/-2) days with 14 day run-in and 14 to 21 day washout periods. The total duration of the study will be approximately 13 to18 weeks for each subject.

Detailed description:

Arms: arm 1: All the subjects in this study will take part in 3 treatment periods and will receive all three treatments (one per period) in a random manner. In one of the treatment periods, subjects will receive FF 100 mcg in the morning (approximately 09:00) and placebo in the evening (approximately 21:00) for 14 days (+/- 2 days). arm 2: All the subjects in this study will take part in 3 treatment periods and will receive all three treatments (one per period) in a random manner. In one of the treatment periods, subjects will receive FF 100 mcg in the evening (approximately 21:00) and placebo in the morning (approximately 09:00) for 14 days (+/-2 days). arm 3: All the subjects in this study will take part in 3 treatment periods and will receive all three treatments (one per period) in a random manner. In one of the treatment periods, subjects in this arm will receive Placebo in the evening and morning (at approximately 09:00 and 21:00) for 14 days (+/- 2 days).
Interventions: intervention 1: Fluticasone Furoate (FF) intervention 2: Placebo
Intervention descriptions: intervention 1: Inhalation powder 100 microgram per blister strip to be administered via dry powder inhaler either in the morning (AM dose with FF and PM dose with +/-2 days). intervention 2: Placebo in single strip to be administered via dry powder inhaler in the morning and evening for 14 days (+/- 2 days).

Protocol documents:
Clinical trial NCT01812837
Conditions: Actinic Keratosis
Keywords: actinic keratosis microneedles photodynamic therapy levulan Aminolevulinic acid
Sponsor: University of California, Davis
Start date: 2012-07-01; Completion date: 2014-03-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The global aim of this study is to investigate how microneedles can facilitate the penetration and efficacy of photodynamic therapy in the treatment of actinic keratoses

The specific aims are as follows:

1. Investigate whether pretreatment with microneedles enhances penetration of topical aminolevulinic acid (ALA) that is marketed as Levulan® Kerasticks by DUSA pharmaceuticals Inc.
2. Investigate whether pretreatment with microneedles can decrease the required incubation times of the topical ALA prior to exposure to blue light photodynamic therapy.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Microneedle intervention 2: Aminolevulinic Acid intervention 3: Blue light
Intervention descriptions: intervention 1: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles. intervention 2: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA intervention 3: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)

Protocol documents:
Clinical trial NCT01814137
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2013-03-01; Completion date: 2014-03-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted globally. The aim of the trial is to compare efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) versus basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c). The trial is an extension to trial NN5401-3941 (NCT01680341).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec/insulin aspart intervention 2: insulin degludec intervention 3: insulin aspart intervention 4: insulin aspart
Intervention descriptions: intervention 1: For subcutaneous (s.c., under the skin) administration twice daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged). intervention 2: For subcutaneous (s.c., under the skin) administration once daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged). intervention 3: For subcutaneous (s.c., under the skin) administration once daily. Dose of IDegAsp and IAsp are individually adjusted. intervention 4: For subcutaneous (s.c., under the skin) administration three times a day. Dose of IDeg and IAsp are individually adjusted.

Protocol documents:
Clinical trial NCT01821391
Conditions: Actinic Keratoses
Keywords: actinic keratoses photodynamic therapy natural daylight
Sponsor: Galderma R&D
Start date: 2013-07-01; Completion date: 2014-03-01
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study was to be conducted as a multi-centre, randomized, investigator-blinded, active and vehicle-controlled, intra-individual (split-face/scalp) non-inferiority (regarding efficacy) and superiority (regarding pain) study.

The primary purpose of this study is to demonstrate the non-inferiority of NDL-PDT compared to c-PDT in terms of lesion complete response rate.

Detailed description:

Arms: arm 1: Metvix natural daylight photodynamic therapy and Metvix conventional photodynamic therapy arm 2: Metvix natural daylight photodynamic therapy and Metvix-placebo conventional photodynamic therapy
Interventions: intervention 1: NDL-PDT intervention 2: c-PDT intervention 3: placebo c-PDT
Intervention descriptions: intervention 1: Metvix natural daylight photodynamic therapy intervention 2: Metvix conventional photodynamic therapy intervention 3: Metvix placebo conventional photodynamic therapy

Protocol documents:
Clinical trial NCT01829464
Conditions: Diabetes
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2013-05-01; Completion date: 2014-03-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of TAK-875 (fasiglifam) in combination with sitagliptin on glycemic control in adults with type 2 diabetes.

Detailed description:
The drug being tested in this study is called TAK-875 (fasiglifam). Fasiglifam is being tested to treat people who have type 2 diabetes mellitus and are currently taking sitagliptin (with or without metformin). This study will evaluate glycemic control in people who take fasiglifam plus sitagliptin compared with placebo plus sitagliptin.

The study will enroll approximately 390 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need; all participants will be on 100 mg sitagliptin and may or may not be on metformin background treatment):

* fasiglifam 25 mg
* fasiglifam 50 mg
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient All participants will be asked to take one tablet at the same time each day throughout the study.

This multi-centre trial will be conducted in North America and Latin America. The overall time to participate in this study is approximately 38 weeks. Participants will make 15 visits to the clinic.

Due to potential concerns about liver safety, on balance, the benefits of treating patients with fasiglifam (TAK-875) do not outweigh the potential risks.

For this reason, Takeda has decided voluntarily to terminate the development activities for fasiglifam.

Arms: arm 1: TAK-875 placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally for up 24 weeks. arm 2: TAK-875 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally for up to 24 weeks arm 3: TAK-875 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally for up to 24 weeks
Interventions: intervention 1: Placebo intervention 2: TAK-875 intervention 3: TAK-875
Intervention descriptions: intervention 1: TAK-875 placebo-matching tablets intervention 2: TAK-875 tablets intervention 3: TAK-875 tablets

Protocol documents:
Clinical trial NCT01834274
Conditions: Diabetes Mellitus, Type 2
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2013-06-01; Completion date: 2014-03-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of fasiglifam (TAK-875) plus metformin compared with sitagliptin plus metformin on glycemic control over a 24-week Treatment Period.

Detailed description:
The drug being tested in this study is called TAK-875. TAK-875 is being tested to treat people who have type 2 diabetes. This study will look at glycemic control in people who take TAK-875 in addition to metformin.

The study will enroll approximately 620 patients. Participants will be 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):

* TAK-875 50 mg
* Sitagliptin 100 mg

All participants will be asked to take one tablet at the same time each day throughout the study. All participants will be asked to self-monitor their blood glucose levels and document any increases in blood glucose or symptoms of hypoglycemia in a diary.

This multi-center trial will be conducted in the United States, Latin America, Europe and Asia. The overall time to participate in this study is up to 42 weeks and participants will make up to 15 visits to the clinic.

Due to potential concerns about liver safety, on balance, the benefits of treating patients with fasiglifam (TAK-875) do not outweigh the potential risks.

For this reason, Takeda has decided voluntarily to terminate the development activities for fasiglifam.

Arms: arm 1: Fasiglifam (TAK-875) 50 mg tablets, orally, once daily, Sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks. arm 2: Sitagliptin 100 mg, tablets, once daily, TAK-875 placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
Interventions: intervention 1: Fasiglifam (TAK-875) intervention 2: Fasiglifam (TAK-875) Placebo intervention 3: Sitagliptin intervention 4: Sitagliptin Placebo intervention 5: Metformin
Intervention descriptions: intervention 1: Fasiglifam (TAK-875) tablets intervention 2: Fasiglifam (TAK-875) placebo-matching tablets intervention 3: Sitagliptin tablets intervention 4: Sitagliptin placebo-matching tablets intervention 5: Metformin tablets

Protocol documents:
Clinical trial NCT01851330
Conditions: Chronic Hepatitis C Virus
Keywords: HCV genotype 1 (GT-1) HCV Sustained Virologic Response Direct Acting Antiviral Combination Therapy GS-7977 GS-5885 Ribavirin Open Label Sofosbuvir Additional relevant MeSH terms: Hepatitis Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action
Sponsor: Gilead Sciences
Start date: 2013-05-01; Completion date: 2014-03-01
Enrollment: 647 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) administered for 8 or 12 weeks in treatment-naive participants with chronic genotype 1 HCV infection.

Detailed description:

Arms: arm 1: Participants will receive LDV/SOF FDC for 8 weeks. arm 2: Participants will receive LDV/SOF FDC plus RBV for 8 weeks. arm 3: Participants will receive LDV/SOF FDC for 12 weeks.
Interventions: intervention 1: LDV/SOF intervention 2: RBV
Intervention descriptions: intervention 1: LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily intervention 2: Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents: