ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00101439
Conditions: Hypercholesterolemia
Keywords: Primary Hypercholesterolemia
Sponsor: Organon and Co
Start date: 2005-11-10; Completion date: 2006-11-08
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A study to evaluate the cholesterol-lowering effects of ezetimibe in participants with primary hypercholesterolemia (high cholesterol) after eating a meal that is high in cholesterol. The primary hypothesis is that treatment with ezetimibe 10 mg/day reduces the cholesterol concentration of the chylomicron-containing Sf≥400 fraction following a cholesterol-enriched test meal.

Detailed description:

Arms: arm 1: After a 2-week single- blind placebo run-in, participants will receive ezetimibe 10 mg once daily for 4 weeks and then receive placebo once daily for 4 weeks. arm 2: After a 2-week single- blind placebo run-in, participants will receive placebo once daily for 4 weeks and then receive ezetimibe10 mg once daily for 4 weeks.
Interventions: intervention 1: ezetimibe intervention 2: Comparator: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01110707
Conditions: Infertility Ovulation Induction
Keywords: Reproductive technology, Assisted Recombinant human follicle stimulating hormone (r-hFSH) Recombinant leutinizing hormone (r-hLH) Ovulation induction Infertility
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2005-01-10; Completion date: 2006-11-15
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a prospective, randomized, Phase II, comparative study with a parallel control for evaluating the efficacy and safety of combined treatment of recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH). The combined treatment was administered at the middle of the follicular phase in subjects undergoing in-vitro fertilisation (IVF) through intracytoplasmic sperm injection (ICSI) and transfer of embryos (ET).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Recombinant human follicle stimulating hormone (r-hFSH) intervention 2: Recombinant human luteinizing hormone (r-hLH)
Intervention descriptions: intervention 1: Subjects will receive subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day \[mg/day\]). intervention 2: Subjects will receive subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation.

Protocol documents:
Clinical trial NCT00385008
Conditions: Migraine Disorders
Keywords: Combination product, sumatriptan succinate, naproxen sodium, absorption, pharmacokinetics, disintegration, gastric transit, gastric scintigraphy
Sponsor: GlaxoSmithKline
Start date: 2006-09-13; Completion date: 2006-11-24
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
An evaluation of tablet disintegration and absorption and gastric transit of sumatriptan and naproxen sodium from a TREXIMA tablet and eletriptan from a RELPAX 40mg tablet.

Detailed description:

Arms: arm 1: open-label active drug arm 2: open-label active drug
Interventions: intervention 1: Combination Product (sumatriptan succinate / naproxen sodium) intervention 2: RELPAX(eletriptan) 40mg Tablet
Intervention descriptions: intervention 1: sumatriptan/naproxen sodium intervention 2: eletriptan tablets

Protocol documents:
Clinical trial NCT00306293
Conditions: Herpes Labialis
Keywords: Recurrent Genital Herpes
Sponsor: GlaxoSmithKline
Start date: 2006-02-20; Completion date: 2006-11-27
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Eligible subjects will be randomized to receive VALTREX 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days in between.

Detailed description:

Interventions: intervention 1: valacyclovir
Intervention descriptions: intervention 1: valacyclovir

Protocol documents:
Clinical trial NCT00078338
Conditions: Relapsing-remitting Multiple Sclerosis
Sponsor: EMD Serono
Start date: 2004-02-16; Completion date: 2006-11-28
Enrollment: 764 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rebif® intervention 2: Copaxone®
Intervention descriptions: intervention 1: Subjects will be administered with Rebif® (Recombinant interferon beta-1a) as subcutaneous (SC) injection at a dose of 44 microgram (mcg) three times weekly (tiw). intervention 2: Subjects will be administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).

Protocol documents:
Clinical trial NCT00174941
Conditions: Gout
Keywords: Uric acid xanthine oxidase tophi Drug Therapy
Sponsor: Takeda
Start date: 2001-03-01; Completion date: 2006-12-01
Enrollment: 116 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the long-term safety of febuxostat, once daily (QD), in maintaining serum urate levels within clinically acceptable levels in subjects with gout.

Detailed description:
Uric acid is the end product of purine degradation in humans. Hyperuricemia, a urate concentration in serum exceeding the limit of urate solubility (approximately 7.0 milligrams per deciliter \[mg/dL\]), is a common biochemical abnormality. Aberrations in any of the multiple mechanisms involved in the production and/or excretion of uric acid may increase serum urate concentrations, with persistent hyperuricemia as a marker for extracellular fluid monosodium urate supersaturation. As such, hyperuricemia is a necessary (but often not sufficient) risk factor for monosodium urate crystal deposition in tissues and is the fundamental pathophysiological process underlying the clinical manifestations of gout, which is a chronic disease characterized by urate crystal formation and deposition in joints and bones. Gout may progress from episodic attacks of acute inflammatory arthritis to a disabling chronic disorder characterized by deforming arthropathy; destructive deposits of urate crystals (tophi) in bones, joints, and other organs; structural and functional renal impairment due to interstitial urate crystal deposition; and urinary tract stones composed entirely or in part of uric acid crystals. Management of gout requires chronic treatment aimed at lowering serum urate into a subsaturating range (usually \<6.0 mg/dL) in which crystal formation and deposition are prevented or reversed.

Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout.

Subjects who want to participate in this study will have successfully completed study TMX-00-004 (NCT00174967).

All participants will initially receive an 80 mg dose. Dose titrations will occur in order to obtain and maintain clinically acceptable serum urate levels.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Febuxostat intervention 2: Febuxostat intervention 3: Febuxostat
Intervention descriptions: intervention 1: Febuxostat 40 mg, tablets, orally, once daily, based on serum urate level. intervention 2: Febuxostat 80 mg, tablets, orally, once daily, based on serum urate level. intervention 3: Febuxostat 120 mg, tablets, orally, once daily, based on serum urate level.

Protocol documents:
Clinical trial NCT00331136
Conditions: Uncomplicated Plasmodium Falciparum Malaria
Keywords: malaria P. falciparum artemisinin based combination therapy (ACT) antimalarial pyronaridine artesunate (Pyramax)
Sponsor: Medicines for Malaria Venture
Start date: 2006-06-01; Completion date: 2006-12-01
Enrollment: 60 participants; Allocation: NON_RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to evaluate three dose levels of a combination tablet and a fixed dose granule formulation of pyronaridine and artesunate (PA) for the treatment of acute uncomplicated falciparum malaria in children.

Detailed description:
This is a Phase II, open-label, sequential-group, dose-escalation, single-centre study to study pharmacokinetics, bioavailability comparison of tablets vs. granules, and safety/tolerability of PA in paediatric patients with acute symptomatic uncomplicated P. falciparum malaria. The study population will include 60 patients, comprising male and female children recruited from a single study site located in the endemic region of Gabon.

Patients will be assigned sequentially to 1 of 4 treatment groups (15 per group): Group A (Tablets) PA (48 mg + 16 mg), Group B (Tablets) PA (72 mg + 24 mg), Group C (Tablets) PA (96 mg + 32 mg), Group D (Granules) PA (60 mg + 20 mg). Oral tablets will be taken once daily for 3 consecutive days (Days 0, 1 and 2). The dose given to each patient depends on the dosing cohort group and the patient's body weight.

Each patient will attend the study site for screening and baseline procedures, as well as receipt of the first dose of study drug on Day 0 (Visit 1, baseline). Patients will be hospitalised for the first 72 hours and remain near the study site for the entire duration of the study. The patients will return to the study site for all scheduled follow-up visits until discharge on Day 42.

The primary efficacy end point for the study is the incidence of patients with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28. In the case of adverse events reported and unresolved at Day 42, patients will be followed up for a further 30 days, or until resolution of the event.

Arms: arm 1: Pyronaridine artesunate 6:2 mg/kg. The tablet strength is 48:16 mg oral PA, with the number of tablets depending on body weight. arm 2: Pyronaridine artesunate 9:3 mg/kg. The tablet strength is 72:24 mg oral PA, with the number of tablets depending on body weight. arm 3: Pyronaridine artesunate 12:4 mg/kg. The tablet strength is 96:32 mg oral PA, with the number of tablets depending on body weight. arm 4: Pyronaridine artesunate 9:3 mg/kg. The sachet of granules strength is 60:20 mg PA, with the number of sachets depending on body weight, and is administered as a suspension with water.
Interventions: intervention 1: Pyronaridine-Artesunate
Intervention descriptions: intervention 1: Once a day for 3 days

Protocol documents:
Clinical trial NCT00375999
Conditions: Stomach Neoplasms
Sponsor: Yonsei University
Start date: 2006-09-01; Completion date: 2006-12-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
1.Study rationale:There is no standard regimen for the advanced and/or metastatic gastric cancer patients who relapsed after adjuvant chemotherapy or failed to first systemic chemotherapy. 2.Primary Objectives:To evaluate overall response rate according to the Response Evaluation Criteria in Solid Tumors criteria and To investigate time to response 3.Design:single-center, Open label, Phase II study. docetaxel 75mg/m2 administered on day 1 as intravenously combined with intravenous Epirubicin 60mg/m2 given day 2 every 3 weeks. 4.Primary endpoints:

1. Efficacy:overall response rate according to the Response Evaluation Criteria in Solid Tumors criteria, time to response, duration of response, and time to treatment failure.
2. Safety-Adverse events and laboratory tests, graded according to the NCI Common Toxicity Criteria for Adverse Effects (version 3.0).

Detailed description:

Arms: arm 1: salvage docetaxel and epirubicin
Interventions: intervention 1: Docetaxel and epirubicin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00389831
Conditions: Restless Legs Syndrome
Keywords: Rotigotine Rotigotine nasal spray Efficacy, safety and tolerability Restless Legs Syndrome
Sponsor: UCB Pharma
Start date: 2006-08-01; Completion date: 2006-12-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of this phase 2a proof-of-concept trial is to assess the efficacy of rotigotine nasal spray in ascending doses in subjects with idiopathic Restless Legs Syndrome.

Detailed description:
Each patient of the placebo and rotigotine group performed an Eligibility Assessment, as well 4 treatment days at which subjects performed a repeated 'Suggested Immobilization Test' (SIT) during a 30min pre-dose and a 4 hours post-dose period. During these periods the severity of RLS symptoms in the legs was assessed by the subject using a numeric symptom severity scale.

In addition the leg movements were measured by actigraphy to assess the Periodic Leg Movement Index during Wakefulness (PLMWI, PLM per hour). Subjects applied a single dose of treatment on each treatment day (placebo nasal spray or rotigotine nasal spray in 3 ascending doses).

Arms: arm 1: Subjects receiving a single dose of placebo nasal spray on all 4 treatment days arm 2: Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4
Interventions: intervention 1: Rotigotine Nasal Spray intervention 2: Placebo Nasal Spray
Intervention descriptions: intervention 1: Daily single dose of 62µg, 124µg, and 247µg rotigotine delivered as single puff of nasal spray solution intervention 2: Daily single dose of placebo delivered as single puff of nasal spray solution

Protocol documents:
Clinical trial NCT00446147
Conditions: Hand-foot Syndrome
Keywords: hand-foot syndrome capecitabine pyridoxine prevention
Sponsor: Asan Medical Center
Start date: 2004-06-01; Completion date: 2006-12-01
Enrollment: 389 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Although pyridoxine has been used empirically for the prevention of capecitabine associated hand-foot syndrome (HFS), its efficacy needs to be demonstrated in prospective controlled trials. The investigators therefore performed a prospective randomized double-blind study to determine whether pyridoxine 200 mg/day can prevent the development of HFS when given concurrently with capecitabine. The investigators also tested the ability of pyridoxine to treat primary occurrence of grade 2-3 HFS.

Detailed description:
Although pyridoxine has been used empirically for the prevention of capecitabine associated HFS, its efficacy needs to be demonstrated in prospective controlled trials. We estimated that the HFS rate with placebo and pyridoxine would be 0.35 and 0.18, respectively, and we therefore calculated that a sample size of 345 patients would be necessary to detect these hazard rates with an 80% power (β=0.2) and two-sided significance level of α=0.05. We assumed a follow up loss rate of 10%, thus requiring 380 patients to be randomized. Chemotherapy-naive patients with gastrointestinal tract cancers who were scheduled for capecitabine-containing chemotherapy were assigned to receive oral pyridoxine or placebo in randomized double-blind placebo controlled study. Pyridoxine 100 mg b.i.d was prescribed to the patients in the pyridoxine group, identical placebo 100 mg b.i.d was prescribed in the placebo group by the closed envelop randomization. Patients were stratified by chemotherapy regimen: capecitabine alone (X), capecitabine and cisplatin (XP), or docetaxel, capecitabine, and cisplatin (DXP). Patients were observed until NCI CTC grade 2 or 3 HFS developed or capecitabine-containing chemotherapy ended. Patients in the placebo group who developed grade 2 or 3 HFS were randomized to receive pyridoxine or placebo for the next chemotherapy cycle to determine whether pyridoxine could improve HFS, and the same treatment was continued for 2 chemotherapy cycles.

Arms: arm 1: one tablet twice per day, which is identical to pyridoxine arm 2: 100 mg twice per day
Interventions: intervention 1: Pyridoxine intervention 2: Placebo
Intervention descriptions: intervention 1: 100mg BID/daily, Per oral intervention 2: placebo 100mg BID/daily, Per oral

Protocol documents:
Clinical trial NCT00697801
Conditions: Asthma
Sponsor: Allergan
Start date: 2006-07-01; Completion date: 2006-12-01
Enrollment: 208 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics of 2 doses of MAP0010 (Unit Dose Budesonide) in asthmatic children/adolescents.

Detailed description:

Arms: arm 1: a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks arm 2: a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks arm 3: Placebo delivered by nebulization twice daily for 6 weeks
Interventions: intervention 1: MAP0010 low dose intervention 2: MAP0010 high dose intervention 3: Placebo
Intervention descriptions: intervention 1: a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks intervention 2: a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks intervention 3: Placebo delivered by nebulization twice daily for 6 weeks

Protocol documents:
Clinical trial NCT00943852
Conditions: Hypertension
Sponsor: Organon and Co
Start date: 2006-08-01; Completion date: 2006-12-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will qualify a functional model that can measure central blood pressure and vascular compliance effects through noninvasive means.

Detailed description:

Arms: arm 1: losartan 100 mg arm 2: ISMN 60 mg arm 3: losartan 100 mg + ISMN 15 mg arm 4: losartan 100 mg + ISMN 60 mg arm 5: Placebo
Interventions: intervention 1: losartan potassium intervention 2: Comparator: isosorbide mononitrate (ISMN) intervention 3: Comparator: losartan + ISMN intervention 4: Comparator: losartan + ISMN intervention 5: Comparator: Placebo
Intervention descriptions: intervention 1: Single dose losartan 100 mg in one of five treatment periods intervention 2: Single dose ISMN 60 mg in one of five treatment periods intervention 3: Single dose losartan 100 mg and ISMN 15 mg in one of five treatment periods intervention 4: Single dose losartan 100 mg and ISMN 60 mg in one of five treatment periods intervention 5: Single dose placebo only in one of five treatment periods

Protocol documents:
Clinical trial NCT01203644
Conditions: Inguinal Hernia
Keywords: Postoperative pain Analgesia
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2004-12-01; Completion date: 2006-12-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to determine the appropriate dose of SKY0402 for the management of postoperative pain following inguinal hernia repair. This study evaluated the safety, efficacy, and pharmacokinetics of SKY0402 compared with a 100 mg dose of bupivacaine HCl for the treatment of postoperative pain in subjects undergoing inguinal hernia repair. Study drug was administered by surgical wound infiltration at the end of the hernia repair procedure.

Detailed description:
SKY0402 was administered in a dose escalating/de-escalating fashion, with a low starting dose in Cohort 1 that was to be increased or decreased in subsequent cohorts based on safety and analgesic effects. The decision to proceed to the next cohort (i.e., increase or decrease the dose) was made by a Cohort Data Review Committee following a review of the data from the previous cohort. Subjects were randomized to receive either SKY0402 or bupivacaine HCl at a ratio of 1:1 in Cohort 1 and at a ratio of 3:1 in subsequent cohorts. The dose of bupivacaine HCl (100 mg) remained constant for all cohorts.

Arms: arm 1: (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402 arm 2: Low dose, low-mid dose, mid-dose, and high dose
Interventions: intervention 1: SKY0402 intervention 2: Bupivacaine HCl
Intervention descriptions: intervention 1: Single dose of SKY0402 administered locally into the surgical wound. intervention 2: Single dose of bupivacaine HCl (100 mg) administered locally into the surgical wound.

Protocol documents:
Clinical trial NCT01206595
Conditions: Postoperative Pain
Keywords: Postoperative Pain Bunionectomy Analgesia
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2005-03-01; Completion date: 2006-12-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to determine the appropriate dose of SKY0402 administered as a nerve block for the management of postoperative pain following bunionectomy.

Detailed description:
This Phase 2, multicenter, randomized, double blind, dose escalating/de-escalating study evaluated the safety, efficacy, and pharmacokinetics of a single dose of SKY0402 compared to a single 125 mg dose of bupivacaine HCl for the treatment of postoperative pain in subjects undergoing bunionectomy.

Up to 88 subjects were to be randomized in five consecutive cohorts. The dose of bupivacaine HCl (125 mg) was to remain constant for all cohorts. After completion of Cohort 1, the decision to increase or decrease the dose of SKY0402 was made by a Cohort Data Review Committee following a review of pharmacokinetic, safety, and selected efficacy data from the previous cohort.

Study drug was to be administered as an ankle block, with or without a tourniquet, between 1 hour before the induction of general anesthesia and 20 minutes before the end of general anesthesia. The ankle block procedure consisted of five injections via three skin entries targeting the following nerves: posterior tibial, sural, deep peroneal, superficial peroneal, and saphenous.

The use of intravenous fentanyl during general anesthesia was permitted, but was not to exceed 250 micrograms. The intraoperative use of morphine was prohibited. Postoperatively, subjects had access to both opioid and non-opioid supplemental pain medication under general guidelines. Blood samples for the determination of plasma bupivacaine concentrations were obtained at Baseline and at specified time points through 96 hours.

Arms: arm 1: Low-dose (175 mg), low-mid dose( 225 mg), and mid-dose (350 mg) arm 2: Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
Interventions: intervention 1: SKY0402 intervention 2: Bupivacaine HCl
Intervention descriptions: intervention 1: Single dose of SKY0402 administered as a nerve block intervention 2: Single dose of 125 mg administered as a nerve block

Protocol documents:
Clinical trial NCT00308685
Conditions: Asthma
Keywords: Asthma Pediatric asthma
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2006-06-10; Completion date: 2006-12-04
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the repeat-dose safety and effectiveness of a bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11 years with asthma. The dosing period lasts three weeks and starts following a three-week run-in period.

Detailed description:

Arms: arm 1: ProAir(TM) HFA, Breath Actuated Inhalation Aerosol arm 2: Placebo
Interventions: intervention 1: Albuterol intervention 2: Placebo
Intervention descriptions: intervention 1: Albuterol 90mcg intervention 2: Placebo

Protocol documents: