ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00328770
Conditions: Liver Carcinoma
Keywords: liver transplant hepatocellular carcinoma sirolimus
Sponsor: University of Alberta
Start date: 1996-12-01; Completion date: 2006-03-01
Enrollment: 70 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study investigates whether sirolimus could decrease the rate of hepatoma recurrence after liver transplantation in high risk hepatoma patients.

Detailed description:
A total of 70 patients with HCC (mean age: 54.6 years, female/male: 12/58) received a liver transplant and were included in the study. Immunosuppression included de novo sirolimus, low-dose calcineurin inhibitor for 6 to 12 months, with short-course (3 months) or no steroids.

Arms: arm 1: Sirolimus given intravenously or orally to achieve serum level of 12-20ug/l
Interventions: intervention 1: Sirolimus
Intervention descriptions: intervention 1: Sirolimus given intravenously or orally to achieve target levels of 12-20ug/l

Protocol documents:
Clinical trial NCT00393510
Conditions: Diabetic Foot Ulcer Amputation
Keywords: Diabetic Foot Ulcer Traditional Chinese Medicine
Sponsor: Chinese University of Hong Kong
Start date: 2000-11-01; Completion date: 2006-03-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Chronic foot ulcers occurring among diabetic patients are difficult to heal. The frequent elderly age with co-morbidities, vascular insufficiencies, peripheral neuropathies and super imposed infections, all contribute towards the chronicity and failure of treatment. Preserving the ulcerated limb is the patients' wish. On the other hand, an infected ulcer that never heals just unnecessarily prolongs suffering. Nevertheless, patients earnestly like to try all methods of healing before accepting amputation.

Objective:To determine whether a course of herbal preparation used as an adjuvant therapy for diabetic patients suffering from chronic foot ulcers may promote healing so that major leg amputation can be avoided.

Detailed description:

Arms: arm 1: 12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day. arm 2: Placebo was made with starch and colouring materials. Given to patient orally twice a day
Interventions: intervention 1: TCM intervention 2: Placebo
Intervention descriptions: intervention 1: The Decoction is taken orally, twice a day, treatment period is 24 weeks The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients.

The formula consisted of 12 herbs, viz:

Radix astragali, Rhizoma atractylodis marcocephalae, Radix stephaniae tetrandrae, Radix polygoni multiflori, Radix rehmanniae, Radix smilax china, Fructus corni, Rhizoma dioscoreae, Cortex moutan, Rhizoma alismatis, Rhizoma smilacis glabrae, and Fructus schisandrae intervention 2: Placebo taking orally, twice a day, 24 week treatment period The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients.

The placebo was made with starch and colouring materials.

Protocol documents:
Clinical trial NCT00441363
Conditions: Type 2 Diabetes
Keywords: diabetes diabetes mellitus
Sponsor: VeroScience
Start date: 2005-02-01; Completion date: 2006-03-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the efficacy and safety of Cycloset® and placebo when added to metformin monotherapy (at least 1000 mg/day for 3 months prior to screening) in persons with type 2 diabetes mellitus who are not adequately controlled on metformin therapy alone.

Detailed description:
In the previously conducted Phase III clinical trials, Cycloset® (up to a maximum dose of 4.8 mg/day), administered either as monotherapy or combined with sulfonylurea therapy, significantly reduced HbA1c, fasting and post-prandial glucose and fasting and post-prandial triglycerides in obese individuals with type 2 diabetes mellitus. Clinical studies that combined Cycloset® with metformin were not as part of the original Cycloset® clinical program because metformin was not commercially available in the United States at the time that the studies were initiated. The present study is designed to investigate the efficacy and safety of Cycloset® compared to placebo when added to metformin monotherapy in persons with type 2 diabetes mellitus who are not adequately controlled on metformin therapy alone.

A sufficient number of individuals will be screened to enroll up to 326 subjects;approximately 276 subjects are expected to complete treatment through study termination (Week 26). The study population will consist of individuals currently treated with metformin, for at least 3 months prior to the study start. Subjects who have ever received exogenous insulin therapy as part of an outpatient diabetes treatment regimen are to be excluded, as are those taking oral anti-diabetic agents other than metformin within 3 months of screening (e.g., sulfonylureas, thiazolidinediones,alpha-glucosidase inhibitors, or meglitinides). Subjects may be male or female(surgically sterile, postmenopausal, or using appropriate contraceptive methods if of childbearing potential), age 18 to 75 years, inclusive, and are to have a screening HbA1c value of ≥ 7.5% and \<11.0% and a screening body mass index (BMI) in the range of 25 kg/m2 to 42 kg/m2, inclusive.

Arms: arm 1: Bromocriptine mesylate 0.8 mg arm 2: Bromocriptine mesylate 0.8 mg matching placebo
Interventions: intervention 1: Bromocriptine Mesylate
Intervention descriptions: intervention 1: 0.8 mg tablet

Protocol documents:
Clinical trial NCT01355588
Conditions: Healthy Volunteers
Sponsor: Egalet Ltd
Start date: 2005-08-01; Completion date: 2006-03-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This was a phase 1, double-blind, 4-way crossover study in healthy male and female volunteers. Subjects received 4 formulations of intranasal ketorolac tromethamine 30 mg. There was a wash-out period of 3-7 days between each dose. On Day 1 of each period subjects were randomised to receive either a single intranasal dose of 30 mg ketorolac tromethamine alone or single intranasal dose of 30 mg ketorolac tromethamine with 4%, 5% or 6% lidocaine hydrochloride. At the end of the study each subject had received all 4 treatments.

The primary objective of this study in healthy volunteers was to compare the safety, tolerability, and pharmacokinetics of 4 formulations of ketorolac tromethamine. A secondary objective was to monitor lidocaine hydrochloride plasma levels.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Ketorolac Tromethamine intervention 2: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) intervention 3: Ketorolac Tromethamine with 5% Lidocaine HCl intervention 4: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl
Intervention descriptions: intervention 1: 30 mg Ketorolac Tromethamine intranasal (IN) intervention 2: 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN intervention 3: 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN intervention 4: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN

Protocol documents:
Clinical trial NCT01183143
Conditions: Infertility Ovulation Induction In-Vitro Fertilization
Keywords: Infertility Ovulation induction Gonal-F Follitropin alpha Controlled ovarian stimulation
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2004-05-11; Completion date: 2006-03-02
Enrollment: 215 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a prospective, open-label, non-comparative, Phase IIIb trial to assess the convenience, safety and efficacy of the new Gonal-F fbm \[recombinant follicle stimulating hormone (r-FSH)\] liquid formulation, in common setting for ovulation induction (OI) and also in in-vitro fertilization (IVF).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: GONAL-f®
Intervention descriptions: intervention 1: GONAL-f® will be administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who undergo ovulation induction (OI)/artificial insemination (IUI) and between 150 and 225 IU per day for subjects who undergo in-vitro fertilization (IVF). For subjects who undergo OI/IUI, the dose will be increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response is observed.

Protocol documents:
Clinical trial NCT00451217
Conditions: Anesthesia, General
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-11-17; Completion date: 2006-03-06
Enrollment: 198 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to demonstrate in adult participants faster recovery from a neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch, T1) by 2.0 mg/kg sugammadex (Org 25969) compared to 50 ug/kg neostigmine.

Detailed description:

Arms: arm 1: After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered arm 2: After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered arm 3: After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered arm 4: After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
Interventions: intervention 1: Sugammadex intervention 2: Neostigmine
Intervention descriptions: intervention 1: After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was to be administered intervention 2: After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered

Protocol documents:
Clinical trial NCT00152464
Conditions: Dermatitis, Atopic
Keywords: EPAAC Atopic children Asthma XYZAL Levocetirizine
Sponsor: UCB Pharma SA
Start date: 2002-03-20; Completion date: 2006-03-15
Enrollment: 514 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Early Prevention of Asthma in Atopic Children (EPAAC™). 24 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in 12 to 24 months old children.

Detailed description:

Arms: arm 1: 0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily. arm 2: Placebo was administered as oral drops twice daily.
Interventions: intervention 1: Placebo intervention 2: Levocetirizine
Intervention descriptions: intervention 1: Pharmaceutical form: Oral drops Route of administration: Oral use intervention 2: Pharmaceutical form: Oral drops Concentration: 5 mg/ml Route of administration: Oral use

Protocol documents:
Clinical trial NCT00087607
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2004-01-01; Completion date: 2006-04-01
Enrollment: 385 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the viral kinetics and pharmacokinetics of Pegasys plus ribavirin and PEG-Intron plus ribavirin in interferon-naive patients with CHC. 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 Peginterferon alfa-2a (40 kD) \[Pegasys\] at a dosage of 180 microgram (μg), subcutaneously (SC), once a week plus Ribavirin \[Copegus\] 1000 or 1200 milligram (mg)/day), orally, \[according to body weight, lesser than or greater than/equal to (\< or \>/=) 75 kilogram (kg), respectively\] twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (\< or \>/=75 kg body weight, respectively twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks. arm 2: Participants received Peginterferon alfa-2b (12 kD) \[PEG-Intron\] at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin \[Rebetol\] 1000 or 1200 mg/day orally (\< or \>/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (\< or \>/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
Interventions: intervention 1: Ribavirin intervention 2: Peginterferon alfa-2b (PEG-Intron) intervention 3: Ribavirin intervention 4: Peginterferon alfa-2a [Pegasys]
Intervention descriptions: intervention 1: 1000/1200mg/day po intervention 2: 1.5 micrograms/kg sc weekly intervention 3: 1000/1200mg/day po intervention 4: 180 micrograms sc weekly

Protocol documents:
Clinical trial NCT00251238
Conditions: Raynaud Disease
Keywords: Raynaud´s phenomenon Vasospastic attacks Ginkgo biloba
Sponsor: VSM Geneesmiddelen b.v.
Start date: 2005-11-01; Completion date: 2006-04-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to investigate the efficacy and safety of EGb 761® in patients with the primary Raynaud phenomenon, with regards to the frequency, duration and severity of vasospastic attacks.

Detailed description:
Despite more than 150 years of research into the pathophysiology of Raynaud´s phenomenon it is still not understood sufficiently. Three mean mechanisms responsible for Raynaud´s phenomenon are discussed and fall into the following three categories:

* neurological malfunction
* pathological blood vessel wall and blood cell interactions
* inflammatory and immunological responses Based on these concepts different classes of drugs have been tested. Although some therapies have shown effects, prolongation of the therapy is often difficult due to side-effects.

Considering a prevalence of 5-10% in the general population, there is still a place and probably a need for the development of new treatment concepts. Ginkgo biloba has shown to have anti-oxidative and anti-platelet activities. In a small placebo controlled trial in patients with the Raynaud´s phenomenon promising results for the Ginkgo biloba extract were shown. EGb 761® is known to be safe and well tolerated. Based on the above considerations, EGb 761® may be an effective treatment for Raynaud´s phenomenon.

Aim: To determine the efficacy and safety of EGb 761® in patients with Raynaud´s phenomenon on the frequency, duration, and severity of vasospastic attacks compared to placebo.

Arms: arm 1: Receiving daily Ginkgo biloba extract EGb 761 arm 2: Receiving daily placebo
Interventions: intervention 1: Ginkgo biloba extract EGb 761
Intervention descriptions: intervention 1: daily Ginkgo biloba extract EGb 761

Protocol documents:
Clinical trial NCT00291642
Conditions: Rhinitis Allergic Seasonal
Keywords: Levocetirizine Xyzal Rhinitis Allergic Seasonal Ragweed
Sponsor: UCB Pharma
Start date: 2006-01-01; Completion date: 2006-04-01
Enrollment: 551 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the efficacy comparability of cetirizine and levocetirizine, by comparing the effects of single intake of the two drugs to placebo in reducing symptoms of seasonal allergic rhinitis (SAR) in ragweed sensitive adult subjects exposed to ragweed pollen in an Environmental Exposure Unit.

Detailed description:

Arms: arm 1: A single dose of placebo was administered orally on Day 1. arm 2: A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1. arm 3: A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1. arm 4: A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. arm 5: A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Interventions: intervention 1: Placebo drops intervention 2: Placebo tablets matching to levocetirizine intervention 3: Placebo tablets matching to cetirizine intervention 4: Levocetirizine drops intervention 5: Levocetirizine tablets intervention 6: Cetirizine drops intervention 7: Cetirizine tablets
Intervention descriptions: intervention 1: * Pharmaceutical form: Drops for oral administration
* Route of administration: Oral use intervention 2: * Pharmaceutical form: Tablets for oral administration
* Route of administration: Oral use intervention 3: * Pharmaceutical form: Tablets for oral administration
* Route of administration: Oral use intervention 4: * Pharmaceutical form: Drops for oral administration
* Concentration: 5 mg/ml
* Route of administration: Oral use intervention 5: * Pharmaceutical form: Tablets for oral administration
* Concentration: 5 mg
* Route of administration: Oral use intervention 6: * Pharmaceutical form: Drops for oral administration
* Concentration: 10 mg/ml
* Route of administration: Oral use intervention 7: * Pharmaceutical form: Tablets for oral administration
* Concentration: 10 mg
* Route of administration: Oral use

Protocol documents:
Clinical trial NCT00329732
Conditions: Migraine
Sponsor: Thomas Jefferson University
Start date: 2006-03-01; Completion date: 2006-04-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Greater Occipital Nerve Blocks (GONB) are a common procedure used for the treatment of headache. The GONB procedure involves a series of injections into the greater occipital nerve (a spinal nerve located at the back of your head). The purpose of this study is to determine whether GONB is effective for the treatment of prolonged migraine attacks. This study is placebo controlled, which means that half of the patients participating will receive injections of active study drug (lidocaine plus bupivicaine) and half of the patients will receive injections of saline (placebo). The study is also blinded which means that neither you nor the study staff will know whether you received active study drug or placebo. The study remains blinded only for the first 30 minutes, at which point additional treatments (including GONB) can be administered at the discretion of your treating physician.

40 patients are expected to participate in this research study. This study is being conducted at Thomas Jefferson University only.

Detailed description:

Arms: arm 1: None arm 2: matching volume of saline injected
Interventions: intervention 1: 0.5% bupivicaine and 2% lidocaine intervention 2: Saline placebo
Intervention descriptions: intervention 1: The injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion. If the subject has a bilateral headache or the headache is known to switch sides then the block will be performed bilaterally. If the headache is strictly unilateral, the block will be performed only on the side of the headache intervention 2: matching volume of saline (placebo)

Protocol documents:
Clinical trial NCT00456755
Conditions: Perennial Allergic Rhinitis
Keywords: Perennial Allergic rhinitis Traditional Chinese Medicine
Sponsor: Chinese University of Hong Kong
Start date: 2004-03-01; Completion date: 2006-04-01
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Allergic rhinitis(AR) is one of the most common allergic disorders throughout the world.The conventional therapies are effective in alleviating symptoms but the efficacy are limited and not persistent. Furthermonre, the cost and side-effect are known defects. A classical Chinese herbal formula, has been used for AR for centries. Our study purpose is to evaluate the clinical efficacy and safety of this formula verus placebo in perennial allergic rhinitis (PAR).

Hypothesis: the classical herbal formula would improve the symptoms of PAR patients and change some immunological parameters in the peripheral blood when comparing with the placebo.

Detailed description:
It is a randomized, double-blind, placebo-controlled trial.

Arms: arm 1: Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba). arm 2: The placebo contained brown colored starch resembling the SBL powder
Interventions: intervention 1: Shi-Bi-Lin intervention 2: Placebo
Intervention descriptions: intervention 1: 4 weeks of treatment, dose of 1 g (two capsules), twice daily intervention 2: 4 weeks of colormatched placebo capsules, dose of 1 g (two capsules), twice daily

Protocol documents:
Clinical trial NCT00834912
Conditions: Healthy
Keywords: Healthy Subjects
Sponsor: Labopharm Inc.
Start date: 2006-02-01; Completion date: 2006-04-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study is to compare the rate and extent of absorption of two Tramadol Contramid® OAD 300 mg controlled-release tablets from two different manufacturing sites, administered as 1 x 300 mg controlled-release tablet under fasting conditions. The effect of food on the to-be-marketed formulation was also assessed.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Tramadol hydrochloride intervention 2: Tramadol HCl intervention 3: Tramadol HCl
Intervention descriptions: intervention 1: 1x300mg Tramadol Hydrochloride (HCl) tablet (Confab Laboratories), fasting condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall. intervention 2: 1x300mg Tramadol Hydrochloride (HCl) tablet (Confab Laboratories), fed condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall. intervention 3: 1x300mg Tramadol Hydrochloride (HCl) tablet (Trillium Healthcare) fasting condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall.

Protocol documents:
Clinical trial NCT00918346
Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: Ocular hypertension
Sponsor: Santen Oy
Start date: 2005-09-01; Completion date: 2006-04-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study is to investigate the pharmacodynamics (as expressed in intraocular pressure \[IOP\]) of two formulations of tafluprost 0.0015% eyedrops (preserved and unpreserved) in patients with open-angle glaucoma or ocular hypertension.

The primary aim of this study is to show that IOP reduction between the two formulations is equivalent at the end of the 4 week treatment period.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tafluprost 0.0015%
Intervention descriptions: intervention 1: Eye drops, 0.015 mg/ml, once daily to affected eye(s)

Protocol documents: