ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01933880
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: Attention Deficit Hyperactivity Disorder Methylphenidate Hydrochloride CONCERTA
Sponsor: Xian-Janssen Pharmaceutical Ltd.
Start date: 2009-12-01; Completion date: 2010-11-01
Enrollment: 194 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this long term post-marketing study is to evaluate the effectiveness and safety of osmotic release oral system methylphenidate hydrochloride (OROS-MPH) in participants with Attention Deficit Hyperactivity Disorder (ADHD).

Detailed description:
This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), self-controlled, long-term post-marketing study in participants with ADHD. The study consists of 3 periods: screening period, wash-out period/run-in period (3 days), and open-label treatment period (12 weeks) which is divided into 2 periods that is dosage adjustment period and dose-optimization period. The total duration of the study is 12 weeks. During the dosage adjustment period, the dose of methylphenidate hydrochloride was adjusted to the optimal dose within 1-3 weeks starting with initial dosage of 18 milligram per day (mg/d) which can be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance. Participants will receive the optimal dose determined during dose adjustment period for 9 weeks during the dose-optimization period. In the study, 2 types of participants will be enrolled in 2 groups (according to condition): OROS-MPH group (participants with ADHD) and the normal children group (healthy participants). The efficacy will be assessed primarily by Digit Span Test and Inattention /Over activity With Aggression (IOWA) Conners evaluation scale. Participants' safety will be monitored throughout the study.

Arms: arm 1: Participants with ADHD will receive OROS -MPH starting at initial dosage of 18 milligram per day (mg/d) which can be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance. arm 2: Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
Interventions: intervention 1: Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH) intervention 2: No intervention
Intervention descriptions: intervention 1: Osmotic release oral system methylphenidate hydrochloride (OROS-MPH) starting at initial dosage of 18 milligram per day (mg/d) which can be increased to 36mg/d up to a maximum dosage of 54mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18mg due to intolerance. intervention 2: Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.

Protocol documents:
Clinical trial NCT02079532
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2006-11-01; Completion date: 2010-11-01
Enrollment: 302 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous inadequate response to a)etanercept, b)infliximab or c)adalimumab. Patients will be treated with MabThera (1g infusion) on day 1 and day 15, and will continue their basic methotrexate therapy. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: rituximab [MabThera]
Intervention descriptions: intervention 1: 1 g was given by intravenous infusion on Days 1 and 15

Protocol documents:
Clinical trial NCT02284880
Conditions: Epilepsy
Sponsor: Bial - Portela C S.A.
Start date: 2010-10-01; Completion date: 2010-11-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Phase I, two-centre, open-label, randomized, gender-balanced, single-dose, laboratory blinded, two-period, two-sequence, crossover study in 2 groups of 20 healthy male and female subjects, to demonstrate the bioequivalence (BE) between two active product ingredient (API) sources of eslicarbazepine acetate (ESL)

Detailed description:
Phase I, two-centre, open-label, randomized, gender-balanced, single-dose, laboratory blinded, two-period, two-sequence, crossover study in 2 groups of 20 healthy male and female subjects. The study consisted in 2 periods separated by a wash-out of at least 7 days between doses. To demonstrate the bioequivalence (BE) between two active product ingredient (API) sources \[current API source - marketed formulation (MF) versus new API source - to-be-marketed (TBM)\] of eslicarbazepine acetate (ESL)

Arms: arm 1: Subjects randomly received on period 1 and 2, either a single 400 mg tablet of ESL (MF - marketed formulation), or a single 400 mg tablet of ESL (TBM - o-be-marketed); arm 2: Subjects randomly received on period 1 and 2, either a single 800 mg tablet of ESL (MF - marketed formulation), or a single 800 mg dose of ESL (TBM - o-be-marketed).
Interventions: intervention 1: BIA 2-093 intervention 2: BIA 2-093
Intervention descriptions: intervention 1: MF - Marketed formulation intervention 2: TBM - to-be-marketed

Protocol documents:
Clinical trial NCT02736721
Conditions: Myelogenous Leukemia, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2003-09-01; Completion date: 2010-11-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy, safety and tolerability of long-term use of peginterferon alfa-2a in participants with CML who have previously participated in peginterferon alfa-2a study ML16544 (NCT number not available), NO16006 (NCT number not available) or ML17228 (NCT number not available) and treating physician has decided to continue treatment with peginterferon alfa-2a within the frame of another clinical study.

Detailed description:

Arms: arm 1: Participants will receive peginterferon alfa-2a subcutaneously in doses between 90 and 450 microgram (mcg) once weekly until medically indicated as judged by the treating investigator.
Interventions: intervention 1: Peginterferon alfa-2a
Intervention descriptions: intervention 1: Peginterferon alfa-2a in doses between 90 and 450 mcg will be administered subcutaneously once weekly until medically indicated as judged by the treating investigator.

Protocol documents:
Clinical trial NCT02948582
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease COPD Emphysema Chronic bronchitis
Sponsor: Sunovion Respiratory Development Inc.
Start date: 2010-07-01; Completion date: 2010-11-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study assessed the safety and ability of an orally inhaled medicine \[i.e., Glycopyrrolate Inhalation Solution = GIS\] to improve airflow in the lungs when delivered using an eFlow nebulizer in 42 patients with Chronic Obstructive Pulmonary Disease (COPD). Each patient randomly received several, single doses of GIS, or placebo, separated by approximately 1 to 2 weeks. After the dose was given, lung airflow was measured over 24 hours and blood was collected to measure how much GIS was in the bloodstream. The study was conducted to find the once-a- day GIS dose that produced the highest improvement in lung airflow using the eFlow nebulizer.

Detailed description:

Arms: arm 1: Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily arm 2: Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily arm 3: Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily arm 4: Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily arm 5: Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily arm 6: Placebo 0.5mL via e-flow nebulizer, once daily
Interventions: intervention 1: Glycopyrrolate Inhalation Solution12.5μg intervention 2: Glycopyrrolate Inhalation Solution 50μg intervention 3: Glycopyrrolate Inhalation Solution 100μg intervention 4: Glycopyrrolate Inhalation Solution 200μg intervention 5: Glycopyrrolate Inhalation Solution 400μg intervention 6: Placebo 0.5mL
Intervention descriptions: intervention 1: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily intervention 2: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily intervention 3: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily intervention 4: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily intervention 5: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily intervention 6: Placebo 0.5mL via eFlow, once daily

Protocol documents:
Clinical trial NCT01131182
Conditions: Type 2 Diabetes Mellitus (T2DM)
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-06-13; Completion date: 2010-11-04
Enrollment: 1147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine whether the incidence of hypoglycemia in patients fasting for Ramadan is lower when treated with sitagliptin as compared to sulfonylurea treatment.

Detailed description:
This study and NCT01340768 (MK-0431-262) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.

Arms: arm 1: Sitagliptin 100 mg administered orally daily as monotherapy or in combination with metformin over the Ramadan period. arm 2: Sulfonylurea administered orally daily as monotherapy or in combination with metformin over the Ramadan period.
Interventions: intervention 1: Sitagliptin phosphate intervention 2: Comparator: Sulfonylurea intervention 3: Metformin
Intervention descriptions: intervention 1: Sitagliptin 100 mg tablet administered orally once daily over the Ramadan period. intervention 2: Sulfonylurea (glibenclamide, glimepiride, or gliclazide) administered orally daily over the Ramadan period as per physician's prescription intervention 3: Participants could continue pre-study metformin as concomitant therapy during the study.

Protocol documents:
Clinical trial NCT00667862
Conditions: Prostate Cancer
Keywords: Prostate Cancer Adenocarcinoma Prostate-Specific Antigen metastatic male HRPC DACi
Sponsor: Novartis Pharmaceuticals
Start date: 2008-03-18; Completion date: 2010-11-05
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This Phase II single dose study was designed to characterize the safety, tolerability, and efficacy of intravenous (i.v.) panobinostat as a single-agent treatment in participants with hormone refractory prostate cancer.

Detailed description:

Arms: arm 1: Participants with metastatic hormone refractory prostate cancer received 20 milligrams per meter square (mg/m\^2) of panobinostat intravenously (i.v.) on Days 1 and 8 of a 21-day cycle. Treatment continued until disease progression as per investigator, intolerable toxicity, start of new cancer therapy, death, or withdrawal of consent.
Interventions: intervention 1: Panobinostat
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00761085
Conditions: Sickle Cell Disease
Sponsor: Washington University School of Medicine
Start date: 2008-01-01; Completion date: 2010-11-07
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the pharmacokinetics of methadone in children and adults with SCD who are experiencing a painful episode.

Detailed description:

Arms: arm 1: Methadone comparison to standard of care for pain management arm 2: Morphine standard of Care pain management arm 3: Methadone comparison to standard of care for pain management arm 4: Morphine standard of Care pain management
Interventions: intervention 1: Morphine intervention 2: Methadone
Intervention descriptions: intervention 1: Standard of care for pain management of acute episode of pain intervention 2: Compare to standard of care for pain management of acute episode of pain

Protocol documents:
Clinical trial NCT00982228
Conditions: Diabetes Diabetes Mellitus, Type 1
Sponsor: Novo Nordisk A/S
Start date: 2009-09-01; Completion date: 2010-11-08
Enrollment: 629 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, Europe and the United States of America (USA).

The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes.

The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension period is registered as NN1250-3644.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec intervention 2: insulin glargine intervention 3: insulin aspart
Intervention descriptions: intervention 1: Injected subcutaneously once daily. Dose was individually adjusted. intervention 2: Injected subcutaneously once daily. Dose individually adjusted. intervention 3: Injected subcutaneously as mealtime insulin. Dose was individually adjusted.

Protocol documents:
Clinical trial NCT00509145
Conditions: Multiple Sclerosis
Keywords: Relapsing Remitting
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2007-11-13; Completion date: 2010-11-08
Enrollment: 1106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS).

Detailed description:

Arms: arm 1: Laquinimod 0.6 mg, oral arm 2: Matching placebo
Interventions: intervention 1: Laquinimod intervention 2: Placebo
Intervention descriptions: intervention 1: Laquinimod 0.6 mg capsule, oral, once daily intervention 2: oral, once daily, capsule

Protocol documents:
Clinical trial NCT01017120
Conditions: Acne Vulgaris
Keywords: Acne
Sponsor: Stiefel, a GSK Company
Start date: 2009-10-01; Completion date: 2010-11-09
Enrollment: 742 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess safety and efficacy of a new foam formulation of tazarotene in subjects with acne vulgaris.

Detailed description:
A multicenter, randomized, double-blind, vehicle-controlled, parallel-group study comparing tazarotene foam with vehicle foam in subjects with acne vulgaris. Approximately 742 subjects will be enrolled and randomized to 1 of the 2 study product groups in a 1:1 ratio (tazarotene foam: vehicle foam). Subjects will apply tazarotene foam or vehicle foam to the entire face once daily for 12 weeks; study visits will occur at baseline (week 0/day 1) and at weeks 2, 4, 8, and 12.

Arms: arm 1: Tazarotene foam, 0.1% arm 2: Vehicle Foam
Interventions: intervention 1: Tazarotene Foam intervention 2: Vehicle Foam
Intervention descriptions: intervention 1: Tazarotene foam once a day application to the face intervention 2: Vehicle Foam once a day application to the face

Protocol documents:
Clinical trial NCT00885352
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-04-15; Completion date: 2010-11-10
Enrollment: 313 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the safety and efficacy of the addition of sitagliptin (MK-0431) compared to placebo in patients with type 2 diabetes mellitus with inadequate glycemic control who are taking pioglitazone and metformin.

Detailed description:

Arms: arm 1: Sitagliptin 100 mg tablet orally once daily for 26 weeks. arm 2: Placebo to sitagliptin orally once daily for 26 weeks.
Interventions: intervention 1: Sitagliptin intervention 2: Comparator: Placebo intervention 3: Pioglitazone intervention 4: Metformin intervention 5: Glipizide
Intervention descriptions: intervention 1: Sitagliptin 100 mg tablet orally once daily for 26 weeks. intervention 2: Placebo to sitagliptin 100 mg tablet orally once daily for 26 weeks. intervention 3: Participants taking 30 mg or more pioglitazone oral tablet(s) daily at screening in combination with metformin will enter a 4-week dose-stable period followed by a 2-week single-blind run-in and a 26-week treatment period. Participants taking 4 mg or more rosiglitazone oral tablet(s) daily at screening in combination with metformin were to be switched to a corresponding dose of pioglitazone prior to starting a 4-week dose-stable period. Participants who are taking less than 30 mg/day or no pioglitazone at screening will be titrated to a stable dose of at least 30 mg pioglitazone once daily over a maximum of 4 weeks followed by a dose-stable period of 10 weeks, a 2-week single-blind placebo run-in, and a 26-week treatment period. Total treatment with pioglitazone will be up to 42 weeks. intervention 4: Participants taking 1500 mg or more metformin oral tablet(s) and at least 30 mg pioglitazone or 4 mg rosiglitazone daily at screening will enter a 4-week dose-stable period followed by a 2-week single-blind placebo run-in, and a 26-week treatment period. Participants who are taking less than 1500 mg/day metformin at screening will be titrated to a stable dose of at least 1500 mg metformin once daily over a maximum of 4 weeks followed by a dose-stable period of 10 weeks, a 2-week single-blind placebo run-in, and a 26-week treatment period. Total treatment with metformin will be up to 42 weeks. intervention 5: Participants not meeting specific glycemic controls during the 26-week treatment period will use glipizide oral tablets as rescue therapy. In countries where glipizide is not available, participants will receive a sulfonylurea marketed in that country.

Protocol documents:
Clinical trial NCT00710684
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease cognition SB-742457
Sponsor: GlaxoSmithKline
Start date: 2008-07-01; Completion date: 2010-11-16
Enrollment: 682 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to investigate the safety and efficacy of SB-742457 when added to stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease.

Detailed description:

Arms: arm 1: SB-742457 - 15mg added to existing donepezil treatment arm 2: Placebo added to existing donepezil arm 3: SB-742457 - 35mg added to existing donepezil
Interventions: intervention 1: SB-742457 15mg intervention 2: SB-742457 35mg intervention 3: Placebo intervention 4: donepezil 5-10mg
Intervention descriptions: intervention 1: SB-742457 - 15mg added to existing donepezil treatment intervention 2: SB-742457 - 35mg added to existing donepezil intervention 3: Placebo added to existing donepezil intervention 4: existing donepezil treatment

Protocol documents:
Clinical trial NCT00856999
Conditions: Glabellar Furrows
Keywords: Glabellar lines of moderate severity at maximum frown
Sponsor: Oregon Health and Science University
Start date: 2005-02-08; Completion date: 2010-11-17
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see if consistent treatment with Botox will lead to longer lasting effects. Botox is an injectable liquid that is approved by the U.S. Food and Drug Administration to reduce wrinkles on the forehead in the area between the eyebrows. In this study a different dosing schedule of Botox injections will be used to see if the effects of the Botox treatment last longer than the effects of the standard injection regimen.

Detailed description:

Arms: arm 1: Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups
Interventions: intervention 1: Botox
Intervention descriptions: intervention 1: Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups

Protocol documents:
Clinical trial NCT00864097
Conditions: Osteoarthritis
Keywords: Arthritis monoclonal antibody nerve growth factor (NGF) anti-NGF tanezumab PF-04383119 RN-624 OA
Sponsor: Pfizer
Start date: 2009-08-11; Completion date: 2010-11-24
Enrollment: 607 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the analgesic efficacy and safety of tanezumab added on to diclofenac SR in patients with osteoarthritis of the knee or hip currently experiencing partial benefit from, and are tolerating, diclofenac 150 mg/day therapy.

Detailed description:
This study was terminated on 16 Nov 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Arms: arm 1: IV tanezumab 10 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32) arm 2: IV tanezumab 5 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32) arm 3: IV tanezumab 2.5 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32) arm 4: IV placebo to match tanezumab every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)
Interventions: intervention 1: tanezumab intervention 2: diclofenac intervention 3: tanezumab intervention 4: diclofenac intervention 5: tanezumab intervention 6: diclofenac intervention 7: diclofenac intervention 8: IV placebo
Intervention descriptions: intervention 1: IV tanezumab 10 mg every 8 weeks (through Week 16) intervention 2: Oral diclofenac SR 75 mg BID for 32 weeks intervention 3: IV tanezumab 5 mg every 8 weeks (through Week 16) intervention 4: Oral diclofenac SR 75 mg BID for 32 weeks intervention 5: IV tanezumab 2.5 mg every 8 weeks (through Week 16) intervention 6: Oral diclofenac SR 75 mg BID for 32 weeks intervention 7: Oral diclofenac SR 75 mg BID for 32 weeks intervention 8: IV placebo to match tanezumab every 8 weeks (through Week 16)

Protocol documents:
Clinical trial NCT01054443
Conditions: Immune Thrombocytopenia (ITP)
Keywords: Blood Platelet Disorders Immune Thrombocytopenia (ITP) Low Platelet Count Thrombocytopaenia S-888711 Splenectomy Thrombopoiesis Hematologic Disease Auto-immune thrombocytopenic Purpura Relapsed Persistent or Chronic ITP Idiopathic Thrombocytopenic Purpura Thrombotic Thrombocytopenic Purpura (TTP)
Sponsor: Shionogi
Start date: 2010-03-18; Completion date: 2010-11-24
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to assess the efficacy of 3 dose levels of lusutrombopag (0.5 mg, 0.75 mg, and 1.0 mg) and placebo on platelet count.

Detailed description:

Arms: arm 1: Participants received placebo tablets orally once a day for 42 days. arm 2: Participants received 0.5 mg lusutrombopag orally once a day for 42 days. arm 3: Participants received 0.75 mg lusutrombopag orally once a day for 42 days. arm 4: Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
Interventions: intervention 1: Placebo intervention 2: Lusutrombopag
Intervention descriptions: intervention 1: Tablet intervention 2: Tablet

Protocol documents: