ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01442376
Conditions: Chemotherapy-Induced Nausea and Vomiting
Keywords: Prevention of Chemotherapy-Induced Nausea and Vomiting Palonosetron Ondansetron Pediatric
Sponsor: Helsinn Healthcare SA
Start date: 2011-09-01; Completion date: 2012-11-01
Enrollment: 502 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to evaluate the efficacy of two different doses of IV palonosetron in the prevention of chemotherapy induced nausea and vomiting in MEC and HEC patients through 120 hours after start of chemotherapy in single and repeated chemotherapy cycles. The secondary objectives are to evaluate the safety and tolerability of IV palonosetron in pediatric patients and evaluate the pharmacokinetics of IV palonosetron in a subset of pediatric CINV patients.

Detailed description:
For neonates (\<28 days, full term) an open-label sub-study will be conducted to assess exposure and tolerability in this age group with escalating doses of palonosetron, starting with 3 mcg/kg to the first three or more neonates included in the study. If this dose is shown to be safe and well tolerated then the following three neonates will be treated with a dose of 10 mcg/kg. If also this dose is safe and well tolerated, then the following three neonates will be treated with a dose of 20 mcg/kg. If this last dose is also shown to be safe and well tolerated, then all the following neonates will be randomized to the main study.

Arms: arm 1: Palonosetron and placebo to Ondansetron

Intervention:

Drug: Palonosetron arm 2: Palonosetron and placebo to Ondansetron

Intervention:

Drug: Palonosetron arm 3: Ondansetron and placebo to Palonosetron

Drug:

Comparator: Ondansetron
Interventions: intervention 1: Palonosetron intervention 2: Palonosetron intervention 3: Ondansetron intervention 4: Placebo to Ondansetron intervention 5: Placebo to Ondansetron intervention 6: Placebo to Palonosetron
Intervention descriptions: intervention 1: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg intervention 2: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg intervention 3: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT01447017
Conditions: Acute Otitis Externa
Sponsor: DermaGen AB
Start date: 2011-11-01; Completion date: 2012-11-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate safety and tolerability of DPK-060 2% ear drops compared to placebo for DPK-060 ear drops in patients with acute external otitis. The secondary objectives are to evaluate clinical cure and microbiological growth following treatment with DPK-060 2% ear drops compared to placebo for DPK-060 ear drops.

Detailed description:

Arms: arm 1: DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable). arm 2: Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
Interventions: intervention 1: DPK-060 intervention 2: Placebo for DPK-060 ear drops
Intervention descriptions: intervention 1: DPK-060 2% ear drops were administered as 3 applications per day into the outer ear by use of a single-dose pipette (0.3 mL/pipette) for 7 days. In case clinical symptoms remained after 7 days of treatment, the treatment period was extended by another 3 days with 3 applications per day. intervention 2: Placebo for DPK-060 ear drops were administered as 3 applications per day into the outer ear by use of a single-dose pipette (0.3 mL/pipette) for 7 days. In case clinical symptoms remained after 7 days of treatment, the treatment period was extended by another 3 days with 3 applications per day.

Protocol documents:
Clinical trial NCT01447420
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2011-02-01; Completion date: 2012-11-01
Enrollment: 129 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This multi-center, open-label study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in treatment-naïve patients with chronic hepatitis C genotype 1. Patients will receive Pegasys (180 mcg sc weekly) and Copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. Anticipated time of study treatment is 48 weeks, follow-up is 24 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: peginterferon alfa-2a intervention 2: ribavirin [Copegus]
Intervention descriptions: intervention 1: 180 mcg sc weekly, 48 weeks intervention 2: 1'000 or 1'200 mg orally daily, 48 weeks

Protocol documents:
Clinical trial NCT01447849
Conditions: Constipation
Keywords: Chronic Constipation
Sponsor: Texas Tech University Health Sciences Center, El Paso
Start date: 2011-08-01; Completion date: 2012-11-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators hypothesize that the symptoms of chronic constipation in some patients are developed due to diminished production and secretion of the alimentary tract mucus resulting in poor lubrication.

Therefore, the investigators assume that administration of lubiprostone may restore this lubrication impairment by stimulation of mucus production and secretion within the gastrointestinal tract.

Detailed description:
Specific Aim 1. To test the effect of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on gastric mucus production in 20 asymptomatic volunteers and 20 patients with chronic constipation in basal conditions (primary outcome).

Specific Aim 2. To explore the effect of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on gastric mucus production in 20 asymptomatic volunteers and 20 patients with chronic constipation during stimulation of gastric secretion with pentagastrin, mimicking the meal-stimulated conditions (primary outcome).

Specific Aim 3. To address the influence of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on gastric mucin production, the major component of mucus, in 20 asymptomatic volunteers and 20 patients with chronic constipation in basal conditions (primary outcome).

Specific Aim 4. To test the influence of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on gastric mucin production, the major component of mucus, in 20 asymptomatic volunteers and 20 patients with chronic constipation during stimulation of gastric secretion with pentagastrin, mimicking the meal-stimulated conditions (primary outcome).

Specific Aim 5. To explore the impact of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on viscoelasticity of gastric mucus in 20 asymptomatic volunteers and 20 patients with chronic constipation in basal conditions (secondary outcome).

Specific Aim 6. To address the impact of Lubiprostone, 24 mcg twice a day (BID) for 1 week, on viscoelasticity of gastric mucus in 20 asymptomatic volunteers and 20 patients with chronic constipation during stimulation of gastric secretion with pentagastrin, mimicking the meal-stimulated conditions (secondary outcome).

Arms: arm 1: Both controls and patients with chronic constipation will receive 1 week of therapy with lubiprostone and one week of placebo. arm 2: Both controls and patients with chronic constipation will receive placebo pills twice daily for one week in cross over design
Interventions: intervention 1: lubiprostone intervention 2: placebo
Intervention descriptions: intervention 1: 24mcg twice a day (BID) 1 week intervention 2: Placebo pills twice a day for one week.

Protocol documents:
Clinical trial NCT01466595
Conditions: HIV-1 Infection
Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Start date: 2011-09-01; Completion date: 2012-11-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being done to see whether rifaximin, an antibiotic that works in the intestines, can lower the amount of germs in the intestines of HIV infected persons. It is possible that when the amount of these germs is lowered, an HIV-infected person's immune system will become less active and will have a better chance of recovering. Also, the study will evaluate the safety of using rifaximin in HIV-infected subjects.

Detailed description:
A5286 is a randomized, open-label, two-arm, pilot (phase II) study that evaluated whether 4 weeks of treatment with rifaximin, a non-absorbable antibiotic, decreases markers of immune activation and levels of translocated gut microbial products in HIV-1 infected subjects virally suppressed on ART with CD4+ T-cells \< 350 cells/mm\^3. Rifaximin were admistered to subjects for 3 weeks. Follow-up continued to week 12. The total sample size was 73 subjects. Subjects were randomized at a 2:1 ratio (rifaximin: no study treatment), using permuted blocks, without institutional balancing.

Subjects were seen through week 12 for clinical and laboratory evaluations, including plasma HIV-1 RNA, CD4+ T-cell count, and safety laboratories. Subjects had 2 baseline visits -- at pre-entry and entry. Study visits were scheduled at weeks 2, 4, 8, and 12. CD4+ T-cell counts and HIV-1 RNA were measured at all weeks; measures of activations, gut-homing markers, and soluble biomarkers were also performed at all weeks.

Arms: arm 1: Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks. arm 2: No study treatment for 4 weeks
Interventions: intervention 1: Rifaximin
Intervention descriptions: intervention 1: Participant were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.

Protocol documents:
Clinical trial NCT01475955
Conditions: Actinic Keratosis
Sponsor: DUSA Pharmaceuticals, Inc.
Start date: 2011-12-01; Completion date: 2012-11-01
Enrollment: 235 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratosis when applied to broad areas on the face and scalp for 1, 2 and 3 hours.

Detailed description:

Arms: arm 1: Broad Area ALA 1-hour incubation arm 2: Broad Area ALA 2-hour incubation arm 3: Broad Area ALA 3-hour incubation arm 4: Spot ALA 2-hour incubation arm 5: VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.
Interventions: intervention 1: Broad Area ALA 1-hour incubation intervention 2: Broad Area ALA 2 hour incubation intervention 3: broad area ALA 3-hour incubation intervention 4: Spot ALA 2 hour incubation intervention 5: Vehicle PDT intervention 6: Blue Light Treatment
Intervention descriptions: intervention 1: 20% ALA, broad area, 1 hour incubation intervention 2: 20% ALA broad area 2-hour incubation intervention 3: 20% ALA broad area 3 hour incubation intervention 4: 20% ALA spot 2 hour incubation intervention 5: Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group. intervention 6: 10 J/cm2 blue light delivered at 10 mW/cm2

Protocol documents:
Clinical trial NCT01487200
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis knee corticosteroid intra-articular injection
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2012-07-01; Completion date: 2012-11-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the safety, pharmacokinetics and pharmacodynamics of FX006 in patients with osteoarthritis of the knee.

Detailed description:
This study was a double-blind, randomized, parallel-group, active comparator design. The study was conducted in male and female patients ≥35 years of age with symptomatic OA of the knee.

Twenty-four (24) patients with knee OA were randomized (1:1:1:1) and treated with a single IA injection of either 10, 40, or 60 mg of FX006 or 40 mg of TCA IR.

Each patient was evaluated for a total of 6 weeks following a single IA injection. Following screening, safety, PK and pharmacodynamics (PD) were evaluated during one (1) 48-hour in-patient period (Day -1 to Day 2), two (2) 24-hour in-patient periods (Day 14-15 and Day 42-43) and seven (7) out-patient visits (Days 3, 4, 5, 8, 22, 29 and 36).

Arms: arm 1: Single 3 mL intra-articular (IA) injection Extended-release formulation arm 2: Single 3 mL intra-articular (IA) injection Extended-release formulation arm 3: Single 3 mL intra-articular (IA) injection Extended-release formulation arm 4: Single 1 mL intra-articular (IA) injection Immediate-release formulation
Interventions: intervention 1: FX006 10 mg intervention 2: FX006 40 mg intervention 3: FX006 60 mg intervention 4: TCA IR 40
Intervention descriptions: intervention 1: single 3 mL IA injection intervention 2: single 3 mL IA injection intervention 3: single 3 mL IA injection intervention 4: single 1 mL IA injection

Protocol documents:
Clinical trial NCT01499368
Conditions: Erosive Esophagitis
Sponsor: Boryung Pharmaceutical Co., Ltd
Start date: 2011-11-01; Completion date: 2012-11-01
Enrollment: 495 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the healing rate and safety of Lafutidine in erosive esophagitis

Detailed description:

Arms: arm 1: Lafutidine 20mg/day arm 2: Famotidine 40mg/day arm 3: Omeprazole 20mg/day
Interventions: intervention 1: Lafutidine intervention 2: Famotidine intervention 3: Omeprazole
Intervention descriptions: intervention 1: Lafutidine 20mg/day intervention 2: Famotidine 40mg/day intervention 3: Omeprazole 20mg/day

Protocol documents:
Clinical trial NCT01499667
Conditions: Relapsing Remitting Multiple Sclerosis (RRMS)
Keywords: Relapsing remitting multiple sclerosis multiple sclerosis (MS) safety tolerability health outcomes fingolimod disease control MRI
Sponsor: Novartis Pharmaceuticals
Start date: 2011-09-01; Completion date: 2012-11-01
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated disease control during different lengths of treatment transition from natalizumab to fingolimod.

Detailed description:
Patient were screened, signed an informed consent at visit 1, at the 2nd visit, all patient received a baseline infusion of Natalizumub and subsequently randomized to one of 3 treatment arms. At the randomization visit, the Washout Phase started, and eligible patients were randomized 1:1:1 to one of three treatment groups:

* 8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod,
* 12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod, or
* 16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod.

Arms: arm 1: 8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day arm 2: 12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day arm 3: 16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
Interventions: intervention 1: Fingolimod intervention 2: Placebo
Intervention descriptions: intervention 1: Fingolimod 0.5 mg capsules for oral administration once daily intervention 2: Matching placebo in capsules for oral administration once daily.

Protocol documents:
Clinical trial NCT01504204
Conditions: Acne Vulgaris
Keywords: adherence adapalene benzoyl peroxide sample topical treatment
Sponsor: Wake Forest University
Start date: 2011-12-01; Completion date: 2012-11-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare adherence to treatment and efficacy with Epiduo® Gel in patients with mild to moderate acne who receive a medication sample and instructions on proper application with their stock size medication tube versus patients who receive only the stock size medication tube.

Detailed description:
Adapalene Topical Gel is a Vitamin A type product in a water-based gel that is applied to the skin. It is approved by the United States Food and Drug Administration (FDA) for the treatment of acne. Benzoyl Peroxide is a medication applied to the skin that is also approved by the FDA for the treatment of acne and has anti-bacterial properties.

The purpose of this study is to evaluate the safety and effectiveness of a drug called Epiduo® Gel 0.1%/2.5% for the treatment of acne vulgaris.Epiduo® is a combination of adapalene and benzoyl peroxide. This combination drug is approved by the FDA for sale in the United States for use in individuals with acne who are over the age of 12.

Arms: arm 1: Subjects will receive a sample tube of the Adapalene + benzoyl peroxide samples with demonstration of how to use it at the first visit. arm 2: Subjects will receive the Adapalene + benzoyl peroxide from standard tube without a sample or demonstration of proper use of the medication.
Interventions: intervention 1: Adapalene + benzoyl peroxide samples intervention 2: Adapalene + benzoyl peroxide from standard tube
Intervention descriptions: intervention 1: A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit. intervention 2: Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.

Protocol documents:
Clinical trial NCT01520987
Conditions: Parkinson Disease
Keywords: Parkinson Disease BIA 9-1067
Sponsor: Bial - Portela C S.A.
Start date: 2011-05-01; Completion date: 2012-11-01
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the pharmacokinetics of BIA 9-1067 in healthy Japanese subjects

Detailed description:
Randomized, double-blind, placebo-controlled, multiple ascending dose, parallel-group, pharmacokinetic (PK) and pharmacodynamic (PD) study

Arms: arm 1: OPC, opicapone, BIA 9-1067 arm 2: OPC, opicapone, BIA 9-1067 arm 3: OPC, opicapone, BIA 9-1067 arm 4: Placebo, PLC arm 5: OPC, opicapone, BIA 9-1067 arm 6: OPC, opicapone, BIA 9-1067 arm 7: OPC, opicapone, BIA 9-1067 arm 8: Placebo, PLC
Interventions: intervention 1: BIA 9-1067 intervention 2: Placebo
Intervention descriptions: intervention 1: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). intervention 2: once-daily

Protocol documents:
Clinical trial NCT01521364
Conditions: Multidrug-resistant Tuberculosis Extensively Drug-resistant Tuberculosis
Keywords: pharmacokinetic drug-interaction linezolid clarithromycin Mycobacterium tuberculosis
Sponsor: University Medical Center Groningen
Start date: 2011-12-01; Completion date: 2012-11-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Future patients might benefit from a combination of linezolid (LIN) and clarithromycin (CLA) in the treatment of Multidrug-resistant and Extensively Drug-resistant Tuberculosis (MDR/XDR-TB) due to possible synergistic activity as shown in in vitro experiments in different Mycobacteria strains. The investigators observed increased LIN serum levels in three cases after combining LIN and CLA of which the investigators described one in a case report (Bolhuis et al). The investigators suggest to conduct a prospective pharmacokinetic study in MDR- and XDR-TB patients to quantify the above described interaction between LIN and CLA.

Detailed description:

Arms: arm 1: Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.

After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.

After this, there is a wash-out period of one week during which no claritromycine is administered.
Interventions: intervention 1: Addition of different doses of clarithromycin.
Intervention descriptions: intervention 1: At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.

At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks.

Protocol documents:
Clinical trial NCT01523886
Conditions: Cholecystectomy, Laparoscopic
Sponsor: Herlev Hospital
Start date: 2012-03-01; Completion date: 2012-11-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this investigation is to compare the surgical conditions during laparoscopic cholecystectomy at a low intra-abdominal pressure with deep or moderate muscle relaxation.

The primary hypothesis is that surgical conditions during laparoscopic cholecystectomy are better with deep muscle relaxation than moderate muscle relaxation.

Detailed description:
The purpose of this investigation is to compare the surgical conditions with two degrees of neuromuscular blockade in patients who have laparoscopic cholecystectomy done with pneumoperitoneum 8 mmHg.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rocuronium intervention 2: Rocuronium
Intervention descriptions: intervention 1: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h intervention 2: Intravenous use: 0,3 mg/kg followed by NaCl-infusion

Protocol documents: