ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00077649
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2004-01-01; Completion date: 2005-12-01
Enrollment: 188 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Participants received 180 μg of PEG-IFN \[peginterferon\] alfa-2a in 1 mL solution administered \[subcutaneously\] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered \[orally \] po daily in split doses for 48 weeks arm 2: Participants received 180 μg of PEG-IFN \[peginterferon\] alfa-2a in 1 mL solution administered \[subcutaneously\] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered \[orally \] po daily in split doses for 48 weeks arm 3: Participants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks arm 4: Participants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
Interventions: intervention 1: ribavirin [Copegus] intervention 2: ribavirin [Copegus] intervention 3: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys] intervention 4: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]
Intervention descriptions: intervention 1: 600mg po bid for 48 weeks intervention 2: 800mg po bid for 48 weeks intervention 3: 180 micrograms sc weekly for 48 weeks intervention 4: 270 micrograms sc weekly for 48 weeks

Protocol documents:
Clinical trial NCT00097708
Conditions: Anxiety Disorder
Keywords: Double Blind, Placebo controlled, Safety and Efficacy Generalized Anxiety Disorder
Sponsor: Jazz Pharmaceuticals
Start date: 2004-11-01; Completion date: 2005-12-01
Enrollment: 511 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.

Detailed description:
Protocol 04-001-01

The primary objective of the study is to assess, under controlled conditions, the safety and efficacy of an experimental anti-anxiety medication relative to placebo in subjects with generalized anxiety disorder (GAD).

The secondary objective of the study is to study algorithms for discontinuation of an experimental anti-anxiety medication.

Recruiting: Participants are currently being recruited and enrolled.

Interventions: intervention 1: experimental anti-anxiety drug
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00107900
Conditions: Arthroplasty, Replacement, Hip Thrombosis
Keywords: Deep Vein Thrombosis, Anticoagulant, Venous thromboembolic
Sponsor: Daiichi Sankyo
Start date: 2005-01-01; Completion date: 2005-12-01
Enrollment: 606 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients who undergo total hip replacement surgery are at greater risk of getting deep vein thrombosis (blood clots). This study evaluates the safety, tolerability and effectiveness of the study drug, DU-176b, in reducing the occurrence of deep vein thrombosis in patients having total hip replacement surgery.

Detailed description:
The primary study objective is to demonstrate prevention of venous thromboembolism in patients undergoing total hip replacement surgery. The secondary objective is to assess the safety and tolerability of DU-176.

Arms: arm 1: 15mg edoxaban administered twice daily (BID) arm 2: 30mg edoxaban administered once daily (QD) arm 3: 30mg edoxaban administered twice daily (BID) arm 4: 60mg edoxaban administered once daily (QD) arm 5: 60mg edoxaban administered twice daily (BID) arm 6: 120mg edoxaban administered once daily (QD)
Interventions: intervention 1: DU-176b
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00123643
Conditions: Type 2 Diabetes Mellitus
Keywords: thiazolidinedione sulfonylurea endothelial function
Sponsor: St. Paul Heart Clinic
Start date: 2003-05-01; Completion date: 2005-12-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the vascular effects of two commonly used diabetes medications, rosiglitazone and glyburide in type 2 diabetic patients.

Detailed description:
Rosiglitazone and glyburide are two commonly used diabetic medications that have both been shown to be effective in controlling blood glucose levels. Since they work in different ways, they may have different effects on the health of the blood vessels. This study will assess which medication is better at improving the health of the arteries separate from the blood glucose lowering effects. Artery health will be assessed non-invasively by ultrasound. Certain markers of atherosclerosis found in the blood will also be measured.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: rosiglitazone intervention 2: glyburide
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00129246
Conditions: Smoking Nicotine Dependence
Keywords: Tobacco Smoking Weight Weight perception Naltrexone Bupropion
Sponsor: Yale University
Start date: 2004-12-01; Completion date: 2005-12-01
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test a combination of the drugs naltrexone and bupropion with weight-concerned smokers to investigate whether or not this combination of drugs improves smoking cessation quit rates and minimizes post quit weight gain.

Detailed description:
This is an open label smoking cessation clinical trial of 25 mg naltrexone with 300 mg bupropion sustained-release (SR) in six male and fourteen female participants. This pilot study is being conducted to determine:

* effect size estimates for smoking cessation and post-cessation weight gain, which will be used to compute the sample size needed for a large-scale clinical trial; and
* compliance with a combination of 25 mg naltrexone and 300 mg bupropion SR. In addition to examining the sample in this study, the investigators plan to compare this sample to a sample of matched controls.

Arms: arm 1: The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day). arm 2: The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).
Interventions: intervention 1: Naltrexone intervention 2: Bupropion
Intervention descriptions: intervention 1: Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment. intervention 2: Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.

Protocol documents:
Clinical trial NCT00189462
Conditions: Acute Otitis Media Otitis Media Ear Infection
Keywords: Ear Infections Otitis Media
Sponsor: Deborah Gentile
Start date: 2004-03-01; Completion date: 2005-12-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this pilot study is to evaluate the efficacy of treatment with montelukast as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)

Detailed description:
Otitis media (OM) is one of the most common childhood disorders requiring physician care and has been associated with an alarming rise in prevalence. Certain children are prone to recurrent episodes of acute Otitis media (RAOM) and/or the development of chronic Otitis media with effusion (COME). Because medical therapy with antibiotics, antihistamines, decongestants and corticosteroids has no demonstrable efficacy, the mainstay of treatment is surgical intervention, which is quite expensive and exposes patients to risks of general anesthesia. The objective of this pilot study is to evaluate the efficacy of treatment with montelukast as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)

Arms: arm 1: Treatment with montelukast for 4 months (4 mg per day) arm 2: Treatment with placebo for 4 months
Interventions: intervention 1: Montelukast intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00236080
Conditions: Chronic Shift Work Sleep Disorder
Sponsor: Cephalon
Start date: 2005-08-01; Completion date: 2005-12-01
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the overnight efficacy and plasma concentration-time profiles of armodafinil and PROVIGIL, after multiple doses, in patients with excessive sleepiness associated with chronic Shift Work Sleep Disorder (SWSD).

Detailed description:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL in Patients with Chronic Shift Work Sleep Disorder

Arms: arm 1: PROVIGIL 200 mg/day arm 2: Armodafinil 250 mg/day arm 3: Armodafinil 200 mg/day arm 4: Armodafinil 150 mg/day arm 5: Placebo
Interventions: intervention 1: PROVIGIL 200 mg intervention 2: Armodafinil 250 mg intervention 3: Armodafinil 200 mg intervention 4: Armodafinil 150 mg intervention 5: Placebo
Intervention descriptions: intervention 1: PROVIGIL 200 mg/day intervention 2: Armodafinil 250 mg/day intervention 3: Armodafinil 200 mg/day intervention 4: Armodafinil 150 mg/day intervention 5: Matching placebo tablets

Protocol documents:
Clinical trial NCT00236951
Conditions: Anemia
Keywords: Anemia Cancer Chemotherapy
Sponsor: American Regent, Inc.
Start date: 2003-02-01; Completion date: 2005-12-01
Enrollment: 224 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly, fixed doses of erythropoietin in patients who had or had not responded to erythropoietin therapy alone.

Detailed description:
This was a two stage, randomized, controlled study of cancer patients undergoing or planning to undergo chemotherapy. After stage one, (where patients were exposed to an erythropoiesis stimulating agent), patients were randomized to receive either IV iron sucrose or no iron supplementation. Patients were then followed to safety and efficacy endpoints.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: iron sucrose injection USP intervention 2: stable erythropoietin therapy
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00335725
Conditions: Infertility
Keywords: Ovarian stimulation Infertility ICSI FSH
Sponsor: IBSA Institut Biochimique SA
Start date: 2003-03-01; Completion date: 2005-12-01
Enrollment: 151 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Purpose of the study is the comparative evaluation of the clinical efficacy and of the general tolerability of two different subcutaneous FSH preparations (Fostimon® IBSA Vs Gonal-F® Serono) when administered in patients undergoing ICSI

Detailed description:
This is a multicentric, prospective, randomised, investigator blind, controlled clinical trial (phase III) of two parallel groups, one receiving the test drug FSH (Fostimon® , IBSA) and the other the reference drug FSH (Gonal-F®, Serono). The groups will be paired on the major prognostic criteria.

In effect, a double blind trial is not really feasible since the drugs presentations are very different. However, in IVF, drugs are usually dispensed and/or injected by a nurse and therefor the Investigator can be blind. Moreover, the used preparations will contain the same amount of gonadotrophin units (75 IU), will be repackaged in anonymous boxes and the following sentence will be written in the Patient Information Sheet: "You are required not to inform the Investigator about the product's name".

The randomisation is necessary to get groups as comparable as possible for all the other aspects. The multicentric design has the double interest of facilitating the patients' recruitment and of decreasing the biases related to attitudes in a specific centre.

Arms: arm 1: Fostimon is an highly purified FSH preparation. arm 2: Gonal-F is a recombinant FSH preparation.
Interventions: intervention 1: Follicle Stimulating Hormone intervention 2: Follicle Stimulating Hormone
Intervention descriptions: intervention 1: subcutaneous injection of FSH. Starting dose: 225 IU. intervention 2: subcutaneous injection of FSH. Starting dose: 225 IU.

Protocol documents:
Clinical trial NCT00367770
Conditions: Pulmonary Arterial Hypertension
Keywords: bosentan PAH related to Eisenmenger physiology Tracleer
Sponsor: Actelion
Start date: 2004-01-01; Completion date: 2005-12-01
Enrollment: 37 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This 6-month open label study will evaluate the long term safety of bosentan (via oxygen saturation) and efficacy (exercise capacity) in patients who have completed the BREATHE-5 study (PAH related to Eisenmenger physiology). Treatment duration is 6 months.

Detailed description:
This is a multicenter, open-label, single -arm study with bosentan, initial dose of 62.5 mg b.i.d., with a target dose of 125 mg b.i.d. All patients will be assessed for eligibility during the baseline visit (same as Week 16, end of study BREATHE-5 visit), and will have the option to enter into the open-label extension study at a starting dose of 62.5 mg b.i.d., for safety reasons. Visit 2 is required as a safety visit to assess oxygen saturation (SpO2) after 1 week of bosentan treatment. Patients will return for Visit 4 after 4 weeks of treatment, and the dose will be up-titrated to 125 mg b.i.d. or maintained at 62.5 mg b.i.d. at the judgement of the investigator. Data will be collected for a total of 24 weeks or until the sponsor decides to stop the study. If the results from Study AC-052-403 or AC-052-405 demonstrate significant safety issues, this extension study may be terminated at the sponsor's request.

Arms: arm 1: The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.
Interventions: intervention 1: Tracleer®
Intervention descriptions: intervention 1: Patients will receive up to 125 mg b.i.d. of Tracleer.

Protocol documents:
Clinical trial NCT00711958
Conditions: Anemia
Keywords: Chemotherapy associated anemia in cancer patients
Sponsor: Sandoz
Start date: 2004-11-01; Completion date: 2005-12-01
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, multicenter clinical phase III study involving about 105 cancer patients aged \>18 years who are receiving palliative chemotherapy and who are suffering from chemotherapy associated anemia. A standard treatment group (ERYPO®) will be included to provide a reference reflecting current standard medical practice.

Detailed description:
Eligible patients were randomized to one of two different treatment groups (EPO HEXAL or ERYPO) in a 2:1 ratio. Patients received double-blind treatment for a period of 12 weeks. Following randomization the patients were treated subcutaneously with a dose of 150 IU/kg body weight of study drug three times per week. Dose adjustments to 300 IU/kg body weight three times per week were to be done if hemoglobin (Hb) increased \<1.0 g/dL or the reticulocyte count increased \<40,000 /μl after 4 weeks or if Hb increased \<2.0 g/dL after 8 weeks of treatment. The primary endpoint was the Hb response in the EPO HEXAL group during weeks 5-12 of the study defined as absolute increase in Hb value of 2.0 g/dL from the mean value of the screening/baseline period in the absence of red blood cell transfusion during the preceding 4 weeks. For that purpose, Hb levels were measured at the weekly study visits by a central laboratory. Further parameters of treatment efficacy, safety and tolerability were recorded.

Arms: arm 1: HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week. arm 2: ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.
Interventions: intervention 1: HX575, solution for injection (s.c.) intervention 2: ERYPO®, Janssen-Cilag, solution for injection (s.c.)
Intervention descriptions: intervention 1: 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin intervention 2: 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa

Protocol documents:
Clinical trial NCT00726414
Conditions: Healthy
Keywords: Bioavailability
Sponsor: Mutual Pharmaceutical Company, Inc.
Start date: 2005-12-01; Completion date: 2005-12-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate and compare the relative bioavailability of Quinine Sulfate capsules following a single, oral dose in healthy volunteers under fasting and fed conditions.

Detailed description:
The purpose of this study is to evaluate and compare the relative bioavailability of Quinine Sulfate capsules following a single, oral dose in healthy volunteers under fasting and fed conditions.

Twenty-two healthy, non-smoking, non-obese, male and female volunteers between the ages of 18 and 45 years of age will be randomly assigned in a crossover fashion to receive each of two Quinine Sulfate dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, subjects will receive either a single oral dose of Quinine Sulfate (2 x 324 mg capsules) following an overnight fast of at least 10 hours, or a single oral dose of Quinine Sulfate (2 x 324 mg capsules) 30 minutes after a standardized, high-fat breakfast. After a 7 day washout period, on the morning of Day 8, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 48 hours post-dose to adequately define the pharmacokinetics of Quinine Sulfate. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and heart rate will be measured prior to dosing and at 1, 2, 4 and 12 hours after each dose and at study exit. A 12 lead electrocardiogram (EKG) will be recorded at study check-in and at 2, 4, 6, 12 and 24 hours after dose administration. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.

Arms: arm 1: A single dose of Quinine Sulfate (2 x 324 mg capsules) administered after an overnight fast of at least 10 hours. arm 2: A single dose of Quinine Sulfate (2 x 324 mg capsules) administered 30 minutes after a standardized, high fat breakfast.
Interventions: intervention 1: Quinine Sulfate 2 x 324 mg Capsules intervention 2: Quinine Sulfate 2 x 324 mg Capsules
Intervention descriptions: intervention 1: Quinine Sulfate (2 x 324 mg capsules) administered after an overnight fast of at least 10 hours. intervention 2: Quinine Sulfate (2 x 324 mg capsules) administered 30 minutes after a standardized, high fat breakfast.

Protocol documents:
Clinical trial NCT00783224
Conditions: Perennial Allergic Rhinitis
Sponsor: Organon and Co
Start date: 2005-09-01; Completion date: 2005-12-01
Enrollment: 351 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was conducted to see if mometasone nasal spray is efficaceous for the treatment of perennial allergic rhinitis. Patients will be randomized to active mometasone, placebo mometasone, active fluticasone, or placebo fluticasone.

Detailed description:

Arms: arm 1: Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray arm 2: Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray arm 3: Mometasone furoate nasal spray 200 μg/day(QD) arm 4: Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
Interventions: intervention 1: Placebo for MF intervention 2: Placebo for FP intervention 3: Mometasone intervention 4: Fluticasone
Intervention descriptions: intervention 1: Placebo to mometasone furoate nasal spray, indistinguishable from mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks intervention 2: Placebo to fluticasone nasal spray, indistinguishable from fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks intervention 3: Mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks intervention 4: Fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks

Protocol documents: