ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01318083
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy
Sponsor: Takeda
Start date: 2008-08-01; Completion date: 2009-04-01
Enrollment: 312 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was evaluate the efficacy and safety of alogliptin, once daily (QD) combined with an Sulfonylurea taken QD or twice daily (BID) in type 2 diabetic patients with uncontrolled blood glucose.

Detailed description:
Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.

The present study was planned to evaluate the efficacy and safety of alogliptin as an add-on to sulfonylurea in type 2 diabetic patients who had uncontrolled blood glucose despite treatment with an sulfonylurea as well as diet and exercise therapies.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Alogliptin and glimepiride intervention 2: Alogliptin and glimepiride intervention 3: Glimepiride
Intervention descriptions: intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks. intervention 3: Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.

Protocol documents:
Clinical trial NCT01318109
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy
Sponsor: Takeda
Start date: 2008-08-01; Completion date: 2009-04-01
Enrollment: 288 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was evaluate the efficacy and safety of alogliptin, once dairy (QD) combined with metformin taken twice daily (BID) or three times daily (TID) in type 2 diabetic patients with uncontrolled blood glucose.

Detailed description:
Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.

The present study was planned to evaluate the efficacy and safety of alogliptin as an add-on to metformin in type 2 diabetic patients who have uncontrolled blood glucose despite treatment with metformin as well as diet and exercise therapies.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Alogliptin and metformin intervention 2: Alogliptin and metformin intervention 3: Metformin
Intervention descriptions: intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks. intervention 3: Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.

Protocol documents:
Clinical trial NCT01443026
Conditions: Intraepithelial Prostatic Neoplasia Prostatic Neoplasms
Keywords: Intraepithelial Prostatic Neoplasia Prostatic neoplasms Male urogenital disease Prostate
Sponsor: University of Illinois at Chicago
Start date: 2006-02-01; Completion date: 2009-04-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to compare the effects of a lycopene supplement made from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal cells in the prostate, but have not yet had cancer detected. This study will allow us to see if taking lycopene for six months leads to favorable changes in abnormal prostate tissue and in chemicals measured in the blood that go along with a higher risk of developing cancer.

Detailed description:

Arms: arm 1: Lycopene 30 mg/day arm 2: Placebo
Interventions: intervention 1: Lycopene 30mg intervention 2: Placebo
Intervention descriptions: intervention 1: Lycopene 30 mg. intervention 2: Placebo

Protocol documents:
Clinical trial NCT01520727
Conditions: Parkinson Disease
Keywords: BIA 9-1067
Sponsor: Bial - Portela C S.A.
Start date: 2007-10-01; Completion date: 2009-04-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study was to investigate the safety, tolerability, pharmacokinetics and catechol-O-methyltransferase (COMT) activity of BIA 9-1067 in healthy male subjects after single oral ascending doses.

Detailed description:
Single centre, randomised, double-blind, placebo-controlled study of single ascending doses in up to 8 sequential groups of 8 healthy young male subjects.

Arms: arm 1: BIA 9-1067 (Opicapone, OPC) - 10 mg arm 2: BIA 9-1067 (Opicapone, OPC) - 25 mg arm 3: BIA 9-1067 (Opicapone, OPC) - 50 mg arm 4: BIA 9-1067 (Opicapone, OPC) - 100 mg arm 5: BIA 9-1067 (Opicapone, OPC) - 200 mg arm 6: BIA 9-1067 (Opicapone, OPC) - 400 mg arm 7: BIA 9-1067 (Opicapone, OPC) - 800 mg arm 8: BIA 9-1067 (Opicapone, OPC) - 1200 mg arm 9: Placebo (PLC): single-dose
Interventions: intervention 1: BIA 9-1067 intervention 2: Placebo
Intervention descriptions: intervention 1: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects intervention 2: single-dose

Protocol documents:
Clinical trial NCT01522391
Conditions: Atopic Dermatitis
Sponsor: DermaGen AB
Start date: 2008-03-01; Completion date: 2009-04-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to evaluate microbial density in eczematous lesions during two weeks of twice daily therapy with the investigational product, DPK-060 1% ointment, compared with placebo in patients with atopic dermatitis. This randomized, double-blind, placebo-controlled part of the study was preceded with an open-label investigation in a small group of patients (n=5) treated with two applications of DPK-060 1% ointment per day for four days to assess safety, local tolerability and systemic absorption of DPK-060.

The secondary objectives were to evaluate severity of eczema and pruritus, to assess the tolerability and safety of the treatment and to assess the degree of systemic absorption of DPK-060 in blood on Day 7 and Day 21 in a sub-set of 10 patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: DPK-060 1% ointment intervention 2: Placebo for DPK-060 ointment
Intervention descriptions: intervention 1: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2 intervention 2: Placebo for DPK-060 ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2

Protocol documents:
Clinical trial NCT01565343
Conditions: Alzheimer's Disease
Keywords: Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging
Sponsor: Avid Radiopharmaceuticals
Start date: 2008-04-01; Completion date: 2009-04-01
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will test if two AV-45 PET scans up to 4 weeks apart in AD subjects and healthy volunteers provide the same results. The study will also test two different AV-45 injection methods in a small subgroup of enrolled AD subjects (slow vs. fast bolus group).

Detailed description:

Arms: arm 1: Two bolus IV injections followed by brain PET scan up to 4 weeks apart arm 2: Two bolus IV injections followed by a brain PET scan up to 4 weeks apart.

The first injection given as a rapid bolus (\< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration). arm 3: Healthy male or female subjects; 35-55 years old. Two bolus IV injections followed by brain PET scan up to 4 weeks apart
Interventions: intervention 1: florbetapir F 18
Intervention descriptions: intervention 1: IV injection, 370MBq (10mCi)

Protocol documents:
Clinical trial NCT01577160
Conditions: Schizophrenia
Keywords: Schizophrenia Paliperidone Extended Release (ER)
Sponsor: Johnson & Johnson Taiwan Ltd
Start date: 2008-05-01; Completion date: 2009-04-01
Enrollment: 353 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effectiveness of paliperidone ER for the treatment of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants.

Detailed description:
This is a multi-center (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), prospective (study following participants forward in time), non-comparative study. The total study duration will be 12 weeks for each participant and will include following visits: Screening, Week 2, 4, 8, and 12 (end of treatment or early withdrawal). The effectiveness of paliperidone ER will be evaluated at Week 12 by the proportion of responders who are evaluated as "very much improved" or "much improved" on the Clinical Global Impression improvement (CGI-I) Scale. Participants' safety will also be monitored throughout the study.

Arms: arm 1: None
Interventions: intervention 1: Paliperidone ER
Intervention descriptions: intervention 1: Participants will receive paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment will be done at Week 2, 4 and 8 as per investigator's discretion based upon participant's CGI-I score.

Protocol documents:
Clinical trial NCT01587950
Conditions: Dentinal Hypersensitivity Dental Pain
Keywords: dentinal sensitivity potassium nitrate dental pain
Sponsor: GlaxoSmithKline
Start date: 2009-02-01; Completion date: 2009-04-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A randomized, controlled, double blind exploratory study to explore the effects of two different potassium nitrate concentrations and water on exposed dentine in reducing dentinal hypersensitivity. Solutions will be applied for either 2, 5 or 10 minutes and assessed by visual analogue scale (VAS) scores following evaporative (air) stimulus.

Detailed description:

Arms: arm 1: Participants to receive 250 microlitres (μL) of sterile water. arm 2: Participants to receive 250 μL of potassium nitrate 5% solution. arm 3: Participants to receive 250 μL of potassium nitrate 2.5% solution.
Interventions: intervention 1: Potassium Nitrate intervention 2: Placebo
Intervention descriptions: intervention 1: 250 μL of Potassium nitrate solution (either 5% or 2.5%) intervention 2: Sterile Water

Protocol documents:
Clinical trial NCT01774929
Conditions: Osteoarthritis
Keywords: Osteoarthritis Transdermal Therapeutic System (TTS)-fentanyl Durogesic
Sponsor: Janssen-Cilag Ltd.,Thailand
Start date: 2008-10-01; Completion date: 2009-04-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants with moderate (medium level of seriousness) to severe (very serious, life threatening) pain of osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff).

Detailed description:
This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), single-arm, prospective (study following participants forward in time), study of TTS-fentanyl in participants with moderate to severe pain of osteoarthritis. The study will consist of 2 phases: screening phase up to 7 days before starting the treatment and treatment phase of 30 days. The first patch will be applied by investigator then by participants until 30 days. The dose of TTS-fentanyl can be increased, if needed, by 12.5 microgram per hour until adequate (reasonably good) pain control is achieved and taking into account the daily dose of supplemental paracetamol required by the participant. Other concomitant (given at the same time) analgesics (drug used to control pain) will not be used during this phase. Efficacy with regard to pain control will be recorded principally by the participant through questionnaires in a daily diary. This record will be used to support more detailed assessments at study visits on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. Participants' safety will be monitored.

Arms: arm 1: TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches will be replaced every 3 days until 30 days.
Interventions: intervention 1: TTS-fentanyl
Intervention descriptions: intervention 1: TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches will be replaced every 3 days until 30 days.

Protocol documents:
Clinical trial NCT01797380
Conditions: Depression HIV
Keywords: Depression HIV
Sponsor: Duke University
Start date: 2008-01-01; Completion date: 2009-04-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the efficacy of escitalopram in treating depression in HIV seropositive women.

Detailed description:
To determine the efficacy of escitalopram in treating depression in HIV seropositive women.

Arms: arm 1: Placebo arm 2: Escitalopram tablet, 10mg, daily, 9 weeks.
Interventions: intervention 1: Placebo intervention 2: Escitalopram
Intervention descriptions: intervention 1: Placebo daily for duration of double-blind portion of trial intervention 2: Escitalopram 10 mg po daily for duration of double-blind portion of trial

Protocol documents:
Clinical trial NCT02497040
Conditions: Hypertension
Keywords: anaesthesia local anaesthesia hemodynamics bupivacaine levobupivacaine
Sponsor: Uludag University
Start date: 2008-03-01; Completion date: 2009-04-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Ninety American Society of Anesthesiologists (ASA) Physical Status classification system I-II patients were recruited for a randomised, placebo-controlled, double-blind study and were randomly divided into three groups to receive either 20 ml of 0.5% bupivacaine (Group B; n=30), 20 ml of 0.5% levobupivacaine (Group L; n=30) or saline as a placebo (Group C; n=30). Scalp block was performed 5 min before head pinning. The primary outcome of the study was mean arterial pressure (MAP) and secondary outcomes were heart rate (HR), visual analogue scale (VAS) scores, additional intraoperative and postoperative drug use. Postoperative pain was evaluated using a 10-cm visual analogue scale (VAS).

Detailed description:
Following approval from the Research Ethics Committee of the Medical Faculty of Uludağ University, (the date and protocol number assigned by this ethics committee were March 4, 2008 and 5/30, respectively),written informed consent was obtained from patients undergoing elective scheduled operations involving craniotomy during anaesthesia consultations. Ninety American Society of Anesthesiologists (ASA) Physical Status classification system I or II patients of either sex between 18-85 years of age were allocated to this randomised, prospective, placebo-controlled, double-blind study. The patients were randomly divided into three groups using a sealed-enveloped technique to receive either 20 ml of 0.5% bupivacaine (Group B (n=30)), 20 ml of 0.5% levobupivacaine (Group L (n=30)) or saline as a placebo (Group C (n=30)). Twenty-millilitre syringes for the block were prepared and numbered by a blinded assistant.

Arms: arm 1: 20 ml of 0.5% bupivacaine 20 ml of 0.5% levobupivacaine arm 2: 20 ml of 0.5% levobupivacaine saline as a placebo arm 3: 20 ml of 0.5% bupivacaine saline as a placebo
Interventions: intervention 1: Levobupivacaine intervention 2: Bupivacaine intervention 3: placebo
Intervention descriptions: intervention 1: local injection intervention 2: local injection intervention 3: local injection

Protocol documents:
Clinical trial NCT02739594
Conditions: Multiple Myeloma
Sponsor: Hoffmann-La Roche
Start date: 2006-02-01; Completion date: 2009-04-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multicenter, open-label trial will randomize participants with multiple myeloma to a regimen of ibandronate or zoledronate in order to compare the incidence of nephrotoxicity, measured as creatinine clearance (CrCl) reduction greater than (\>) 30 percent (%) or an absolute value of 30 milliliters per minute (mL/min) or lower.

Detailed description:

Arms: arm 1: Participants with multiple myeloma will be randomized to receive ibandronate every 4 weeks for a planned duration of 92 weeks. arm 2: Participants with multiple myeloma will be randomized to receive zoledronate every 4 weeks for a planned duration of 92 weeks.
Interventions: intervention 1: Ibandronate intervention 2: Zoledronate
Intervention descriptions: intervention 1: Ibandronate will be administered via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for 92 weeks. intervention 2: Zoledronate will be administered via 15-minute IV infusion as 4 mg every 4 weeks for 92 weeks.

Protocol documents:
Clinical trial NCT00735371
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Sponsor: Shire
Start date: 2008-10-08; Completion date: 2009-04-06
Enrollment: 314 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: LDX 30 mg intervention 2: LDX 50 mg intervention 3: LDX 70 mg intervention 4: Placebo
Intervention descriptions: intervention 1: Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind. intervention 2: Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind. intervention 3: Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind. intervention 4: Placebo will be identical to test product.

Protocol documents:
Clinical trial NCT00717769
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis SUN13834
Sponsor: Daiichi Sankyo
Start date: 2008-07-16; Completion date: 2009-04-09
Enrollment: 270 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to explore the efficacy and safety of SUN13834 vs placebo in adult participants with atopic dermatitis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: SUN13834 intervention 2: Placebo
Intervention descriptions: intervention 1: Low dose, orally 3 times a day (tid) for 28 days of SUN13834 intervention 2: Placebo, orally (tid) for 28 days of SUN13834

Protocol documents:
Clinical trial NCT00729651
Conditions: Osteoporosis Postmenopausal
Sponsor: Organon and Co
Start date: 2008-03-20; Completion date: 2009-04-10
Enrollment: 343 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate the efficacy/safety of Fosamax Plus D

Detailed description:

Arms: arm 1: Alendronate sodium/Cholecalciferol arm 2: Alendronate sodium
Interventions: intervention 1: alendronate sodium (+) cholecalciferol intervention 2: Comparator: Alendronate sodium (Fosamax) intervention 3: Comparator: Calcium
Intervention descriptions: intervention 1: Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks intervention 2: Alendronate sodium; tablet, once weekly, for 16 weeks intervention 3: 500 mg oral tablet calcium once daily, for 16 weeks

Protocol documents:
Clinical trial NCT00601172
Conditions: Nausea and Vomiting, Chemotherapy-Induced
Keywords: vomiting colorectal cancer nausea oxaliplatin
Sponsor: GlaxoSmithKline
Start date: 2008-03-10; Completion date: 2009-04-13
Enrollment: 710 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This a Phase III trial designed to determine if IV casopitant plus dexamethasone and ondansetron is more effective in the prevention of vomiting and nausea then dexamethasone and ondansetrone alone following the administration of moderately emetogenic oxaliplatin-based chemotherapy.

Detailed description:

Arms: arm 1: Placebo + standard antiemetics arm 2: Casopitant + standard antiemetics
Interventions: intervention 1: Casopitant intervention 2: Dexamethasone intervention 3: Placebo intervention 4: Ondansetron
Intervention descriptions: intervention 1: Experimental NK-1 receptor antagonist intervention 2: Standard antiemetics intervention 3: Placebo to match IV casopitant intervention 4: Standard antiemetics

Protocol documents:
Clinical trial NCT00603642
Conditions: Idiopathic Thrombocytopenic Purpura
Keywords: AMG 531 Idiopathic Thrombocytopenic Purpura ITP Thrombocytopenia Japan Placebo controlled Phase 3
Sponsor: Amgen
Start date: 2007-10-01; Completion date: 2009-04-13
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of AMG 531 compared with placebo in thrombocytopenic Japanese subjects with immune (idiopathic) thrombocytopenic purpura (ITP) .

Detailed description:

Arms: arm 1: Double blinded placebo-controlled study arm 2: None
Interventions: intervention 1: Placebo intervention 2: AMG 531
Intervention descriptions: intervention 1: Subcutaneously administered, once a week, for 12 weeks intervention 2: Subcutaneously administered, once a week, for 12 weeks

Protocol documents: