ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01594931
Conditions: Plasmodium Falciparum Malaria
Keywords: malaria antimalarial artemisinin based combination therapy (ACT) pyronaridine artesunate (Pyramax)
Sponsor: Medicines for Malaria Venture
Start date: 2005-07-01; Completion date: 2006-04-01
Enrollment: 477 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary trial objective is to determine the clinically effective dose of orally administered pyronaridine/artesunate (Pyramax®, PA) with a 3:1 ratio to treat adults with acute, symptomatic, uncomplicated P. falciparum malaria in South East Asia and Africa. Secondary trial objectives are to determine the safety of once-daily dosing for 3 days of PA and to explore possible ethnic differences in safety or efficacy.

Detailed description:
This is a double-blind, multicentre, randomized, parallel group, dose-finding study of the efficacy, safety and tolerability of a once-daily 3-day regimen of PA with a 3:1 weight/weight ratio for patients with acute, symptomatic, uncomplicated P. falciparum malaria. Patients will be recruited from 5 to 7 study sites in endemic regions of South East Asia and Africa and will be randomized to 1 of 3 treatment groups differing in dosage, with 160 patients per group (n-480). Randomization will be balanced within each study site across all 3 study groups in pre-assigned treatment blocks.

The first dose will be administered on Day 0 and patients will remain hospitalized for at least 4 days whilst undertaking the 3-day regimen. Patients will remain near the study site for a minimum of 7 days or once fever and parasite clearance is confirmed (assessed by 3 negative readings of fever and/or slide).

The primary efficacy end point is the cure rate on Day 28 - the proportion of patients with PCR-corrected adequate clinical and parasitological response (ACPR). Despite this Day 28 end point, the relatively long half-life of pyronaridine necessitates follow-up until Day 42. 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 tetraphosphate 6 mg/kg and artesunate 2 mg/kg arm 2: pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg arm 3: pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg
Interventions: intervention 1: pyronaridine/artesunate
Intervention descriptions: intervention 1: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1. The tablets were taken daily for 3 days.

Protocol documents:
Clinical trial NCT02490475
Conditions: Solid Tumor
Sponsor: Hoffmann-La Roche
Start date: 2004-02-01; Completion date: 2006-04-01
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of rhuMab 2C4 (Perjeta) and docetaxel (Taxotere) in participants with advanced solid tumors that have progressed during or after standard therapy, or for which no standard therapy is available. Participants will be enrolled and evaluated for dose-limiting toxicities (DLTs) in escalating-dose cohorts in order to determine the maximum tolerated dose (MTD).

Detailed description:

Arms: arm 1: Docetaxel will be administered via intravenous (IV) infusion on Day 1 of each 3-week cycle at a dose of 100 mg/m\^2 per day, and rhuMab 2C4 will be given on Day 1 of each 3-week cycle as a fixed-dose 420-mg IV infusion. For Cycle 1 only, rhuMab 2C4 administration will be delayed to Day 2 with an initial 840-mg loading dose. The incidence of DLTs will be used to guide intrapatient dose modification, as well as subsequent enrollment. arm 2: Docetaxel will be administered via IV infusion on Day 1 of each 3-week cycle at a dose of 60 mg/m\^2 per day, and rhuMab 2C4 will be given on Day 1 of each 3-week cycle as a fixed-dose 420-mg IV infusion. For Cycle 1 only, rhuMab 2C4 administration will be delayed to Day 2 with an initial 840-mg loading dose. The incidence of DLTs will be used to guide intrapatient dose modification, as well as subsequent enrollment. arm 3: Docetaxel will be administered via IV infusion on Day 1 of each 3-week cycle at a dose of 75 mg/m\^2 per day, and rhuMab 2C4 will be given on Day 1 of each 3-week cycle as a fixed-dose 420-mg IV infusion. For Cycle 1 only, rhuMab 2C4 administration will be delayed to Day 2 with an initial 840-mg loading dose. The incidence of DLTs will be used to guide intrapatient dose modification, as well as subsequent enrollment.
Interventions: intervention 1: Docetaxel intervention 2: RhuMab 2C4
Intervention descriptions: intervention 1: Participants will receive docetaxel on Day 1 of each 3-week cycle as 60, 75, or 100 mg/m\^2 via IV infusion. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal. intervention 2: Participants will receive rhuMab 2C4 on Day 1 of each 3-week cycle as 420 mg via IV infusion. For Cycle 1 ony, rhuMab will be administered on Day 2, at least 24 hours after docetaxel and following an initial 840-mg loading dose. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.

Protocol documents:
Clinical trial NCT05065905
Conditions: HIV Coinfection Aids/Hiv Problem Tuberculosis, Pulmonary Human Immunodeficiency Virus Lentivirus Infections RNA Virus Infections
Keywords: interferon gamma, IFN-g, HIV infection, tuberculosis
Sponsor: SPP Pharmaclon Ltd.
Start date: 2006-01-19; Completion date: 2006-04-06
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to assess the safety and efficacy of interferon-gamma by subcutaneous injection in complex treatment of patients with co-infection of HIV and pulmonary tuberculosis and to determine the rational of its use.

Detailed description:
Study will evaluate safety and efficacy of the investigational medical product (IMP) - interferon-gamma - in participants with HIV-infection and pulmonary tuberculosis.

Interferon-gamma (immune interferon) is an important anti-inflammatory cytokine produced by NK-cells, CD4 Th1 cells and CD8 cytotoxic supressor cells. Interferon-gamma blocks viral replication, viral proteins synthesis and assembly of mature viral particles. Causes cytotoxic effects on the cells infected by intracellular pathogens. Possess a bright immunomoduling action. Thus, the use of interferon-gamma is patogenetically rational in patients co-infected with tuberculosis and HIV.

The aim of interferon-gamma use is to achieve a viral replication control, support CD4 level and help abacillation process. In this randomised, controlled safety and efficacy study interferon gamma will be administered in a daily dose of 500,000 IU daily or every other day.

The treatment regimen in this study will also include a basic antituberculosis therapy.

The available clinical data do not suggest a risk for serious adverse events (SAEs) from the IMP used in chosen doses.

The study will screen HIV-infected participants 18-50 years old with pulmonary tuberculosis. Participants who provide informed consent and meet study entry criteria will be randomised into 1 of 3 parallel treatment groups. The study will last 30 days, during which participants will receive IMP in various regimens according to the group.

Arms: arm 1: All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU alternated with Interal® (interferon alpha) 3,000,000 IU every other day

Interventions:

Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy arm 2: All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU given with Interal® (interferon alpha) 3,000,000 IU every day

Interventions:

Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy arm 3: All participants receive only basic antimicrobial treatment

Interventions:

Drug: Antituberculosis complex therapy
Interventions: intervention 1: Interferon-Gamma
Intervention descriptions: intervention 1: received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein

Protocol documents:
Clinical trial NCT00118716
Conditions: Bronchospasm Activity/Exercise Induced Bronchospasm
Keywords: asthma bronchospasm
Sponsor: GlaxoSmithKline
Start date: 2003-12-23; Completion date: 2006-04-23
Enrollment: 248 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
During this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ECG) tests, and lung function tests. All study related medications and medical examinations are provided at no cost. All study drugs are currently available by prescription to patients 4 years and older.

Detailed description:

Arms: arm 1: Participants received FSC 100/50 microgram (mcg) one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days arm 2: Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
Interventions: intervention 1: Fluticasone propionate/salmeterol intervention 2: Fluticasone Propionate
Intervention descriptions: intervention 1: Fluticasone propionate/salmeterol intervention 2: Fluticasone Propionate

Protocol documents:
Clinical trial NCT00142454
Conditions: Malignant Melanoma
Keywords: Malignant melanoma Stages IIB-III
Sponsor: Ludwig Institute for Cancer Research
Start date: 2005-08-24; Completion date: 2006-04-25
Enrollment: 9 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This was a Phase 1, single-arm, open-label, pilot study of NY-ESO-1 protein vaccination with imiquimod as an adjuvant in patients with resected Stage IIB, IIC, and III malignant melanoma. The primary study objective was to determine the safety of NY-ESO-1 protein/imiquimod treatment, and the secondary objective was to evaluate the immunogenicity of treatment.

Detailed description:
Patients applied imiquimod (250 mg) topically to a designated area of healthy skin on the upper inner arm or inner thigh (the cream remained on the skin overnight for 6-10 hours) every day for 5 consecutive days (i.e., for the first 5 days of Cycles 1-3 and for the first 4 days of Cycle 4). The NY-ESO-1 protein (100 μg) was injected intradermally into the imiquimod-pretreated area on Day 3 of each cycle for 4 consecutive 21-day cycles.

Safety was monitored continuously. Immunization was assessed by the generation of NY-ESO-1-specific cluster of differentiation (CD)4+ and CD8+ T cell responses in enzyme-linked immunosorbent spot (ELISPOT) assays and by the development or augmentation of NY-ESO-1-specific antibody titers, assessed by enzyme-linked immunosorbent assay (ELISA).

Blood samples were obtained for the assessment of clinical biochemistry and hematology, and physical examinations were performed at baseline, on Day 1 of each cycle, and at a follow-up visit at Week 13.

Skin biopsies of the vaccinated area were obtained 48 hours after the last injection (Day 5 of Cycle 4). To avoid irritation, imiquimod was not applied after the biopsies.

Arms: arm 1: Patients applied topical imiquimod followed by vaccination with intradermal injections of the NY-ESO-1 protein.
Interventions: intervention 1: Imiquimod intervention 2: NY-ESO-1 protein
Intervention descriptions: intervention 1: Patients applied imiquimod cream at bedtime every day for 5 consecutive days (for the first 5 days of Cycles 1-3 and for the first 4 days of Cycle 4) at a dose of 250 mg as supplied in single-use packets to a 4 x 5 cm area of healthy skin, alternating among the extremities (upper inner arms and inner thighs) in each cycle. The cream was to be rubbed into the skin until it was no longer visible. Patients were encouraged to wash their hands before and after applying cream. The application site was not occluded. The next morning, 6 to 10 hours after initial application, the treated area was washed with mild soap and water to remove any residual cream. intervention 2: NY-ESO-1 protein was injected intradermally by a study physician or nurse at a dose of 100 μg into the imiquimod-pretreated area on Day 3 of each cycle for 4 consecutive 21-day cycles.

Protocol documents:
Clinical trial NCT00094757
Conditions: Diabetes Mellitus, Type 2
Sponsor: Merck Sharp & Dohme LLC
Start date: 2004-10-06; Completion date: 2006-04-28
Enrollment: 521 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus.

Detailed description:

Arms: arm 1: Sitagliptin 100 mg arm 2: Sitagliptin 200 mg arm 3: Placebo/Pioglitazone
Interventions: intervention 1: Comparator: sitagliptin 100 mg intervention 2: Comparator: sitagliptin 200 mg intervention 3: Comparator: placebo intervention 4: Comparator: pioglitazone
Intervention descriptions: intervention 1: sitagliptin 100 mg oral tablet once daily for 54 weeks intervention 2: sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks intervention 3: placebo oral tablet once daily during Phase A (Weeks 0-18) intervention 4: pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)

Protocol documents:
Clinical trial NCT00168805
Conditions: Arthroplasty, Replacement, Knee Thromboembolism
Sponsor: Boehringer Ingelheim
Start date: 2004-11-01; Completion date: 2006-05-01
Enrollment: 2101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s \[150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery\] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)

Detailed description:

Arms: arm 1: 220 mg once daily arm 2: 150 mg once daily arm 3: 40 mg once daily
Interventions: intervention 1: enoxaparin intervention 2: dabigatran etexilate intervention 3: dabigatran etexilate
Intervention descriptions: intervention 1: 40 mg once daily intervention 2: 150 mg once daily intervention 3: 220 mg once daily

Protocol documents:
Clinical trial NCT02598934
Conditions: Post Menopausal Osteoporosis
Sponsor: Hoffmann-La Roche
Start date: 2004-08-01; Completion date: 2006-05-01
Enrollment: 308 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.

Detailed description:

Arms: arm 1: Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 1 will receive a physician consultation after 4 months of treatment to review bone turnover test results. arm 2: Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 2 will not receive a physician consultation.
Interventions: intervention 1: Ibandronate
Intervention descriptions: intervention 1: Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.

Protocol documents:
Clinical trial NCT00224120
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign prostatic hyperplasia, alpha blocker
Sponsor: Watson Pharmaceuticals
Start date: 2005-05-01; Completion date: 2006-05-01
Enrollment: 462 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.

Detailed description:
This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. the following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the Internation Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.

Arms: arm 1: Silodosin 8 mg/Day with food arm 2: Matching placebo capsule once daily with food
Interventions: intervention 1: Silodosin intervention 2: Placebo
Intervention descriptions: intervention 1: 8 mg daily for 12 weeks intervention 2: One capsule daily for 12 weeks

Protocol documents:
Clinical trial NCT00246337
Conditions: Migraine
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-11-01; Completion date: 2006-05-01
Enrollment: 420 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the efficacy and safety of an MK 0974 for migraine headache and to identify an appropriate dose range for further study.

Detailed description:

Arms: arm 1: Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache. arm 2: MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. arm 3: MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. arm 4: MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. arm 5: MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. arm 6: MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. arm 7: MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. arm 8: MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. arm 9: Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Interventions: intervention 1: Comparator: Placebo intervention 2: MK0974 intervention 3: MK0974 intervention 4: MK0974 intervention 5: MK0974 intervention 6: MK0974 intervention 7: MK0974 intervention 8: MK0974 intervention 9: Rizatriptan
Intervention descriptions: intervention 1: Placebo to match assigned treatment arm; one orally-administered dose intervention 2: MK0974 25 mg; one orally-administered dose intervention 3: MK0974 50 mg; one orally-administered dose intervention 4: MK0974 100 mg; one orally-administered dose intervention 5: MK0974 200 mg; one orally-administered dose intervention 6: MK0974 300 mg; one orally-administered dose intervention 7: MK0974 400 mg; one orally-administered dose intervention 8: MK0974 600 mg; one orally-administered dose intervention 9: Rizatriptan 10 mg; one orally-administered dose

Protocol documents:
Clinical trial NCT00359138
Conditions: Hypersensitivity
Keywords: Histamine H1 Antagonists Anti-Allergic Agents
Sponsor: Organon and Co
Start date: 2006-02-01; Completion date: 2006-05-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, double-dummy, placebo-controlled, parallel-group, single center study in subjects with positive histamine skin prick test and a positive RadioAllergoSorbent Test (RAST) (class \> 2) to one of the tested standardized allergenic extracts: tree pollen, cat dander, house dust mite, or a mixture of five grass pollens. Subjects will be randomized to desloratadine 5 mg once daily, levocetirizine 5mg once daily, or placebo once daily for 8 days of treatment followed by 11 days of skin testing after discontinuation of the antihistamine treatment phase. The duration of the suppressive effects of desloratadine on cutaneous allergen-induced wheal and flare responses after discontinuation of a one-week treatment will be established.

Detailed description:

Arms: arm 1: Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). arm 2: Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). arm 3: Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
Interventions: intervention 1: desloratadine intervention 2: levocetirizine intervention 3: Desloratadine placebo tablet intervention 4: Levocetirizine placebo capsule
Intervention descriptions: intervention 1: 5 mg tablet once daily intervention 2: 5 mg capsule once daily intervention 3: once daily intervention 4: once daily

Protocol documents:
Clinical trial NCT00375713
Conditions: Dermatitis Eczema
Keywords: Dermatitis Eczema Pruritus Xyzal Zyrtec Levocetirizine Cetirizine
Sponsor: UCB Pharma
Start date: 2005-10-01; Completion date: 2006-05-01
Enrollment: 466 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Korean double-blind non-inferiority study to asses the efficacy (as measured by the responder rate of pruritus severity score by the patient at visit 4 or end-of-treatment visit over the 2 weeks treatment period) and safety of Xyzal® to Zyrtec® in subjects suffering from dermatitis and eczema with pruritus symptoms

Detailed description:

Arms: arm 1: Levocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days arm 2: Cetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
Interventions: intervention 1: Levocetirizine intervention 2: Cetirizine intervention 3: Placebo-Levocetirizine intervention 4: Placebo-Cetirizine intervention 5: Standard topical steroid (1% hydrocortisone) ointment
Intervention descriptions: intervention 1: 1 Levocetirizine 5mg tablet per day before bedtime for 14 days intervention 2: 1 Cetirizine 10mg tablet per day before bedtime for 14 days. intervention 3: 1 Placebo-Levocetirizine tablet per day before bedtime for 14 days intervention 4: 1 Placebo-Cetirizine tablet per day before bedtime for 14 days intervention 5: 1% hydrocortisone ointment, applied 2-3 times a day to all affected areas

Protocol documents: