ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00147316
Conditions: Cerebral Infarction Brain Ischemia
Keywords: acute stroke thrombolytic therapy tissue plasminogen activator
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2002-04-01; Completion date: 2003-09-01
Enrollment: 103 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Based on previous studies comparing Duteplase\[a recombinant tissue plasminogen activator (rt-PA) very similar to alteplase\] doses, we performed a clinical trial with 0.6mg/kg, which is lower than the internationally approved dosage of 0.9mg/kg, aiming to assess the efficacy and safety of alteplase for the Japanese.

Detailed description:
Based on previous studies comparing Duteplase ( an rt-PA very similar to alteplase) doses, we performed a clinical trial with 0.6mg/kg, which is lower than the internationally approved dosage of 0.9mg/kg, aiming to assess the efficacy and safety of alteplase for the Japanese.

The primary endpoints were the rate of patients with mRS score of 0-1 at 3 months and the incidence of sICH within 36 hours. Thresholds for these endpoints were determined by calculating 90% confidence intervals of weighted averages derived from published reports. The protocol was defined according to the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA stroke study with slight modifications.

Arms: arm 1: 0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
Interventions: intervention 1: Alteplase
Intervention descriptions: intervention 1: 0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour

Protocol documents:
Clinical trial NCT00181168
Conditions: Thyroid Cancer
Keywords: thyroid cancer PET scan recombinant thyrotropin thyroglobulin Thyroid cancer, differentiated epithelial
Sponsor: Johns Hopkins University
Start date: 2001-03-01; Completion date: 2003-09-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine \[for patients with previously treated well-differentiated thyroid cancer and evidence of residual disease based on serum thyroglobulin (Tg) level\] whether positron emission tomography-computed tomography (PET-CT) fusion scanning performed after recombinant thyroid-stimulating hormone (TSH) (rTSH, thyrotropin alfa for injection) will be more sensitive for the detection of disease sites than PET-CT scanning without rTSH. The study will also determine if this information will significantly alter the therapeutic approach in some patients.

Detailed description:
PET/CT was performed before (basal PET) and 24 - 48 h after rhTSH administration (rhTSH-PET) in 63 patients (52 papillary and 11 follicular thyroid cancers). Images were blindly analyzed by two readers. The proposed treatment plan was prospectively assessed before basal PET, after basal PET, and again after rhTSH-PET.

Arms: arm 1: Euthyroid Group: Subjects received rhTSH to prepare for radioiodine therapy. arm 2: Hypothyroid Group: Thyroid hormone treatment was withheld before radioiodine therapy.
Interventions: intervention 1: Euthyroid Group
Intervention descriptions: intervention 1: Euthyroid Group: Received rhTSH to prepare for radioiodine therapy.

Protocol documents:
Clinical trial NCT01046084
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2003-08-01; Completion date: 2003-09-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The object of this study is to compare the relative bioavailability of lansoprazole 30 mg delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP Pharmaceuticals, Inc.) in healthy, adult, subjects under non-fasting conditions.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms: arm 1: Lansoprazole 30 mg Delayed-Release Capsule arm 2: Prevacid® 30 mg Delayed-Release Capsule
Interventions: intervention 1: Lansoprazole intervention 2: Prevacid®
Intervention descriptions: intervention 1: 30 mg Delayed-Release Capsule intervention 2: 30 mg Delayed-Release Capsule

Protocol documents:
Clinical trial NCT01070979
Conditions: Hormone Replacement Therapy
Sponsor: Warner Chilcott
Start date: 2003-02-01; Completion date: 2003-09-01
Enrollment: 249 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multicenter, double-blind, controlled, parallel group, randomized study to compare the clinical benefit of Estradiol acetate tablets, estradiol tablets and conjugated equine estrogen tablets, each administered orally, once daily, to postmenopausal women.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Estradiol acetate intervention 2: Estradiol intervention 3: Conjugated equine estrogens
Intervention descriptions: intervention 1: Tablet containing 0.9 mg E3A, daily oral administration. intervention 2: Tablet containing 1 mg estradiol, daily oral administration. intervention 3: Tablet containing 0.625 mg CEE, daily oral administration.

Protocol documents:
Clinical trial NCT01218958
Conditions: Alcoholism
Keywords: Alcoholism
Sponsor: Alkermes, Inc.
Start date: 2002-02-01; Completion date: 2003-09-01
Enrollment: 624 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study conducted in subjects diagnosed with alcohol dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV). Subjects were randomized (2:2:1:1) to receive intramuscular (IM) injections of Medisorb® naltrexone 190 mg, Medisorb naltrexone 380 mg, placebo for Medisorb naltrexone 190 mg, or placebo for Medisorb naltrexone 380 mg (VIVITROL®). Study drug was administered every 4 weeks for a total of 6 injections.

Detailed description:
All subjects received standardized biopsychosocial support therapy (BRENDA Approach \[Volpicelli, JR \[2001\]; Guilford Press: New York\]) at each visit.

Subjects who completed this study (ie, received 6 injections of study drug and completed all study visits) and continued to meet eligibility criteria were given the option to enroll in extension study ALK21-003EXT (NCT01218971). A second extension, Study ALK21-010 (NCT00156923), was conducted subsequent to ALK21-003EXT.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Medisorb naltrexone 190 mg intervention 2: Medisorb naltrexone 380 mg intervention 3: Placebo matching Medisorb naltrexone 190 mg intervention 4: Placebo matching Medisorb naltrexone 380 mg
Intervention descriptions: intervention 1: Intramuscular (IM) injection once every 4 weeks for a total of 6 administrations. intervention 2: IM injection once every 4 weeks for a total of 6 administrations. intervention 3: IM injection once every 4 weeks for a total of 6 administrations. intervention 4: IM injection once every 4 weeks for a total of 6 administrations.

Protocol documents:
Clinical trial NCT00003499
Conditions: Low-Grade Lymphoma
Keywords: Low-grade non-Hodgkin's lymphoma
Sponsor: Burzynski Research Institute
Start date: 1996-03-06; Completion date: 2003-09-13
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Current therapies for Low-grade Non-Hodgkin's Lymphoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Low-grade Non-Hodgkin's Lymphoma.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Low-grade Non-Hodgkin's Lymphoma.

Detailed description:
Low-grade Non-Hodgkin's Lymphoma patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with Low-grade Non-Hodgkin's Lymphoma, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in patients with Low-grade Non-Hodgkin's Lymphoma.
* To determine objective response, tumor size is measured utilizing physical examination, radiologic studies, and bone marrow biopsies as necessary, performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Arms: arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Interventions: intervention 1: Antineoplaston therapy (Atengenal + Astugenal)
Intervention descriptions: intervention 1: Patients with Low-grade non-Hodgkin's lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal).

The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Protocol documents:
Clinical trial NCT00220727
Conditions: Purpura, Thrombocytopenic, Idiopathic
Keywords: Idiopathic (Immune) Thrombocytopenic Purpura Immunoglobulin G
Sponsor: Grifols Therapeutics LLC
Start date: 2003-07-01; Completion date: 2003-10-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatograph Purified (IGIV-C) is similar when infused at two different infusion rates.

Detailed description:
This is a prospective, randomized, single-center, open, cross-over trial in patients with a confirmed diagnosis of Idiopathic Thrombocytopenia Purpura (ITP). ITP is defined as isolated thrombocytopenia in a patient with no other clinically apparent associated conditions or factors that are known to cause thrombocytopenia as defined by the ITP Practice Guidelines Committee of the American Society of Hematology.

Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) at a dose of 1.0 g/kg will be given on 2 occasions as a single daily infusion for platelet counts \< 30,000 microliters (uL) or if clinically indicated, at maximum intervals of six weeks. Eligible patients will be randomized into one of two cross-over groups. Patients randomized to Group 1 will receive their first IGIV-C infusion at a rate of 0.08 mL/kg/min and their second infusion at a rate of 0.14 mL/kg/min. Conversely patients randomized to Group 2 will receive their first IGIV-C infusion at a rate of 0.14 mL/kg/min and their second infusion at a rate of 0.08 mL/kg/min according to the following schema:

Group 1:

* Infusion #1 (Week 0) IGIV-C (0.08 mL/kg/min)
* Infusion #2 (Week \<6) IGIV-C (0.14 mL/kg/min)

Group 2:

* Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min)
* Infusion #2 (Week \<6) IGIV-C (0.08 mL/kg/min)

Arms: arm 1: Infusion #1 (Week 0) IGIV-C (0.08 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.14 mL/kg/min) arm 2: Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week \<6) IGIV-C (0.08 mL/kg/min)
Interventions: intervention 1: Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified
Intervention descriptions: intervention 1: IGIV-C 10% at a dose of 1.0g/kg was to be given on 2 occasions as a single daily infusion: Group 1 were to receive their first IGIV-C, 10-% infusion at a rate of 0.08 mL/kg/min and a second infusion at 0.14 mL/kg/min. and Group 2 were to receive their first IGIV-C, 10-% infusion at a rate of 0.14 mL/kg/min and a second infusion at a rate of 0.08 mL/kg/min.

Protocol documents:
Clinical trial NCT01621009
Conditions: Tobacco Dependence Smoking
Keywords: smoking cessation medications smoking cessation counseling
Sponsor: University of Wisconsin, Madison
Start date: 2001-01-01; Completion date: 2003-10-01
Enrollment: 463 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine if bupropion plus counseling was more effective than bupropion alone or counseling alone in helping smokers quit smoking.

Detailed description:

Arms: arm 1: Active bupropion SR plus eight 10-minute individual counseling sessions. arm 2: Active bupropion, No counseling, only medication checks arm 3: Placebo bupropion plus eight 10-minute individual counseling sessions arm 4: Placebo bupropion, No counseling, just medication checks
Interventions: intervention 1: Active bupropion + counseling intervention 2: Active bupropion, No counseling intervention 3: Placebo medication + counseling intervention 4: Placebo medication, No counseling
Intervention descriptions: intervention 1: Medications-Pre-quit: 150 mg bupropion per day 7 days before quit attempt, then 150 mg twice daily for 4 days before quit attempt; then 150 mg bupropion twice daily for eight weeks.

Counseling-Pre-quit: two 10 minutes sessions before quit date; eight 10-minute sessions post quit date. intervention 2: Medication - 150 mg bupropion per day starting week before quit day, then 150 mg twice daily 3 days before quit day, then 150 mg twice daily for eight weeks after quit day.

Counseling: No cessation counseling, only medication checks intervention 3: Placebo bupropion once daily 7 days before quit day, then twice daily 4 days before quit attempt, then twice daily for 8 weeks after quit day.

Counseling: Two 10-minutes sessions before quit day, then eight 10-minutes sessions for eight weeks after quit day. intervention 4: Pre-quit: Placebo medication once daily 7 days before quit day, then twice daily before quit day, then twice daily for 8 weeks after quit day.

Counseling: No counseling, just medication checks

Protocol documents:
Clinical trial NCT00092131
Conditions: Asthma, Exercise-Induced
Sponsor: Organon and Co
Start date: 2003-06-01; Completion date: 2003-11-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the effect of an approved medication being studied in support of a new approach in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also known as exercise-induced bronchospasm), in participants who have a history of worsening asthma after exercise.

Detailed description:

Arms: arm 1: Montelukast - Placebo arm 2: Placebo - Montelukast
Interventions: intervention 1: Comparator: Montelukast intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge intervention 2: Placebo tablet administered orally as a single witnessed dose before exercise challenge

Protocol documents:
Clinical trial NCT01124162
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2003-10-01; Completion date: 2003-11-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study is to compare the rate and extent of absorption of losartan 100 mg tablets (test) versus Cozaar® (reference), administered as 1 \* 100 mg tablet under fasting conditions.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms: arm 1: Losartan 100mg Tablets arm 2: Cozaar® 100 mg Tablets
Interventions: intervention 1: Losartan intervention 2: Cozaar®
Intervention descriptions: intervention 1: 100 mg Tablet intervention 2: 100 mg Tablet

Protocol documents:
Clinical trial NCT01124175
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2003-10-01; Completion date: 2003-11-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study is to compare the rate and extent of absorption of losartan 100 mg tablets (test) versus Cozaar® (reference), administered as 1 \* 100 mg tablet under fed conditions.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms: arm 1: Losartan 100 mg Tablets arm 2: Cozaar® 100 mg Tablets
Interventions: intervention 1: Losartan intervention 2: Cozaar®
Intervention descriptions: intervention 1: 100 mg Tablets intervention 2: 100 mg Tablets

Protocol documents:
Clinical trial NCT00070707
Conditions: Rhinitis, Allergic, Seasonal Asthma
Keywords: Seasonal Allergic Rhinitis Asthma
Sponsor: Organon and Co
Start date: 2003-04-03; Completion date: 2003-11-26
Enrollment: 188 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare mometasone nasal spray to placebo in treating the nasal and asthma symptoms experienced by participants with seasonal allergic rhinitis (SAR) and concomitant asthma.

Detailed description:

Arms: arm 1: Mometasone nasal spray 200 mcg, administered once daily (QD) for 4 weeks arm 2: Matching placebo nasal spray, administered QD for 4 weeks
Interventions: intervention 1: Mometasone intervention 2: Placebo intervention 3: Albuterol/Salbutamol
Intervention descriptions: intervention 1: Mometasone nasal spray 200 mcg/day administered as 2 sprays (50 mcg/spray) in each nostril. intervention 2: Matching placebo nasal spray, administered QD as 2 sprays in each nostril. intervention 3: Albuterol/salbutamol metered dose inhaler (90 mcg/puff) used as needed as asthma rescue medication.

Protocol documents:
Clinical trial NCT00053417
Conditions: Multiple Sclerosis
Keywords: Walking Ability Muscle strength Spasticity
Sponsor: Acorda Therapeutics
Start date: 2003-02-01; Completion date: 2003-12-01
Enrollment: 206 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the Central Nervous System (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR (Sustained Release, SR) is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will evaluate the effects of Fampridine-SR on the walking ability of subjects with MS, as well as to examine the effects on muscle strength and spasticity. The study will also examine the possible risks of taking Fampridine-SR.

Detailed description:

Arms: arm 1: Placebo control, twice a day (b.i.d.) arm 2: 10 milligram (mg) fampridine b.i.d. arm 3: 15 mg fampridine b.i.d. arm 4: 20 mg fampridine b.i.d.
Interventions: intervention 1: Placebo intervention 2: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP) intervention 3: 15 mg fampridine-SR (4-aminopyridine, 4-AP) intervention 4: 20 mg fampridine-SR (4-aminopyridine, 4-AP)
Intervention descriptions: intervention 1: Placebo for 15 weeks intervention 2: 2 week up titration (10 mg)

12 weeks stable dose (10 mg)

1 week down titration (10 mg) intervention 3: 10 mg twice daily for 1 week

15 mg twice daily for 14 weeks

2 week up titration (10 mg x 1 week, 15 mg x 1 week)

12 weeks stable dose (15 mg)

1 week down titration (10 mg) intervention 4: 2 week up titration (10 mg x 1 week, 15 mg x 1 week)

12 weeks stable dose (20 mg)

1 week down titration (15 mg x 3 days, 10 mg x 4 days)

Protocol documents:
Clinical trial NCT00803738
Conditions: Vulvovaginal Candidiasis
Keywords: Vulvovaginal Candidiasis Terconazole
Sponsor: Padagis LLC
Start date: 2002-12-01; Completion date: 2003-12-01
Enrollment: 572 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg(Test Product) and Terconazole Vaginal Suppositories, 80 mg(Reference Product) in the treatment of subjects with vulvovaginal candidiasis in order to establish bioequivalence.

Detailed description:

Arms: arm 1: Terconazole Vaginal Suppository arm 2: Terazol Vaginal Suppository
Interventions: intervention 1: Terconazole Vaginal Suppository intervention 2: Terazol Vaginal Suppository
Intervention descriptions: intervention 1: Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days intervention 2: Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days

Protocol documents:
Clinical trial NCT01679002
Conditions: Epilepsy
Keywords: Epilepsy Oxcarbazepine Eslicarbazepine Acetate BIA 2-093
Sponsor: Bial - Portela C S.A.
Start date: 2003-10-01; Completion date: 2003-12-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To investigate the steady-state pharmacokinetics of once-daily and twice-daily regimens of BIA 2-093 and twice-daily regimen of Oxcarbazepine (Trileptal®) in healthy subjects and to assess the tolerability of such regimens in healthy subjects.

Detailed description:
Single centre, open-label, randomised, three-way crossover study in 12 healthy volunteers. The study consisted of three 8-day treatment periods separated by washout periods of 10-15 days. On each of the treatment periods the volunteers received either a daily oral dose of BIA 2-093 900 mg once-daily (od), BIA 2-093 450 mg twice-daily (bid), or Oxcarbazepine (Trileptal®) 450 mg bid.

Arms: arm 1: BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period

BIA 2-093 450 mg od - BIA 2-093 450 mg bid - OXC 900 mg bid arm 2: BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period

BIA 2-093 450 mg bid - OXC 450 mg bid - BIA 2-093 900 mg od arm 3: oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period

OXC 450 mg bid - BIA 2-093 900 mg od - BIA 2-093 450 mg bid
Interventions: intervention 1: BIA 2-093 intervention 2: Oxcarbazepine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: