ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01121484
Conditions: Major Depressive Disorder
Sponsor: Pfizer
Start date: 2010-06-01; Completion date: 2011-06-01
Enrollment: 439 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multicenter, 10-week study to evaluate the efficacy and safety of 50 mg of desvenlafaxine succinate sustained-release formulation (DVS SR) versus placebo in the treatment of peri- and postmenopausal women with major depressive disorder

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: desvenlafaxine succinate sustained-release intervention 2: placebo
Intervention descriptions: intervention 1: 50-mg DVS SR tablets taken orally once daily. intervention 2: Placebo tablets taken orally once daily.

Protocol documents:
Clinical trial NCT01123980
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2010-05-01; Completion date: 2011-06-01
Enrollment: 521 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of biphasic insulin aspart 30 once daily compared to insulin glargine once daily both in combination with metformin and glimepiride in Chinese and Japanese subjects with type 2 diabetes who have never received insulin before.

The trial is conducted as a phase 4 trial in China and phase 3 in Japan.

Detailed description:

Arms: arm 1: 0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride arm 2: 0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
Interventions: intervention 1: biphasic insulin aspart 30 intervention 2: metformin intervention 3: glimepiride intervention 4: insulin glargine
Intervention descriptions: intervention 1: Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily. intervention 2: China: Tablets, 500 mg. Min. 1500 mg/day.

Japan: Tablets, 250 mg. Min 500 mg/day. intervention 3: China: Tablets, 2 mg. Min. 4 mg/day.

Japan: Tablets, 1 mg. Min. 4 mg/day. intervention 4: Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily.

Protocol documents:
Clinical trial NCT01126671
Conditions: Vitamin D Supplementation
Keywords: vitamin D
Sponsor: Boston Children's Hospital
Start date: 2008-11-01; Completion date: 2011-06-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This double blind, randomized controlled trial compares two supplemental doses of vitamin D in health adolescents.

Detailed description:
Vitamin D deficiency is a common problem. Currently, data do not support a recommended vitamin D supplementation dose for health adolescents to maintain normal vitamin D levels. This double blind, randomized controlled 12 week trial compares the use of two supplemental doses of vitamin D in this population.

Arms: arm 1: Subjects are randomized to take 200 IU vitamin D3 daily in this arm. arm 2: Subjects are randomized to take 1000 IU vitamin D3 daily in this arm.
Interventions: intervention 1: Supplemental Vitamin D
Intervention descriptions: intervention 1: Subjects were randomized to either take 200 IU of vitamin D or 1000 IU of vitamin D daily for 11 weeks and labs were compared before and after.

Protocol documents:
Clinical trial NCT01127438
Conditions: Sedation
Keywords: Monitored anesthesia care sedation
Sponsor: Eisai Inc.
Start date: 2010-04-01; Completion date: 2011-06-01
Enrollment: 153 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of LUSEDRA (fospropofol disodium) and to determine whether a dose lower than currently approved can provide effective moderate sedation required to complete diagnostic or therapeutic procedures.

Detailed description:
This will be a double-blind, randomized, parallel-group, multicenter, dose-ranging study, in age \>/= 65 years, and/or weight \< 60 kg, and/or American Society of Anesthesiologists (ASA) Physical Classification Status 3 or 4 subjects using either the approved dose modification or 1 lower dose, to achieve a moderate level of sedation required to complete the scheduled diagnostic or therapeutic procedure. Three subgroups of subjects will be included. For Subgroup 1 and Subgroup 2, approximately equal numbers of subjects will be enrolled into 2 strata: weight \>/= 55 kg and weight \< 55 kg. For Subgroup 1 and Subgroup 2, subjects will be randomly assigned to 1 of 2 dose groups in a 1:1 ratio within each stratum. For Subgroup 3, subjects will be randomly assigned to 1 of 2 dose groups in a 1:1 ratio.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: fospropofol disodium Subgroup 1 Lower Dose intervention 2: fospropofol disodium Subgroup 1 Approved Dose intervention 3: fospropofol disodium Subgroup 2 Lower Dose intervention 4: fospropofol disodium Subgroup 2 Approved Dose intervention 5: fospropofol disodium Subgroup 3 Lower Dose intervention 6: fospropofol disodium Subgroup 3 Approved Dose
Intervention descriptions: intervention 1: Dose of Initial IV (Titration) Bolus 6.5mg/kg) (administered to Subgroup 1, Weight \< 60 kg and Age \< 65 years and ASAI and II) intervention 2: (Dose of Initial IV (Titration) Bolus 385mg) (Administered to Subgroup 1, Weight \<60 kg and Age \<65 years and ASAI and II) intervention 3: Dose of Initial IV (Titration) Bolus 4.875 mg/kg) (administered to Subgroup 2, Weight \< 60 kg and Age \>/=65 years and ASA 3 or 4 intervention 4: (Dose of Initial IV (Titration) Bolus 297.5mg) (Administered to Subgroup 2, Weight \<60 kg and Age \>/=65 years and ASA 3 or 4 intervention 5: (Dose of Initial IV (Titration) Bolus 3.9mg/kg) (Administered to Subgroup 3, Weight \>/= 60 kg and Age \>/= 65 years and ASA 3 or 4 intervention 6: Dose of Initial IV (Titration) Bolus 4.875 mg/kg) (Administered to Subgroup 3, Weight \>/= 60 kg and Age \>/= 65 years and ASA 3 or 4

Protocol documents:
Clinical trial NCT01128153
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes Inadequate Glycaemic Control Saxagliptin Metformin Sulfonylurea Triple Oral Therapy
Sponsor: AstraZeneca
Start date: 2010-06-01; Completion date: 2011-06-01
Enrollment: 257 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the addition of saxagliptin to a patient's combination treatment of metformin and sulfonylurea for a 24 week period will provide better control of the patient's type 2 diabetes and will be well tolerated.

Detailed description:
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study to Evaluate Efficacy and Safety of Saxagliptin in Combination with Metformin and Sulfonylurea in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control with Combination of Metformin and Sulfonylurea

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Saxagliptin intervention 2: Placebo
Intervention descriptions: intervention 1: 5 mg tablet once daily for 24 weeks to be taken orally intervention 2: tablet once daily for 24 weeks to be taken orally

Protocol documents:
Clinical trial NCT01163162
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease Vitamin D
Sponsor: Indiana University
Start date: 2010-08-01; Completion date: 2011-06-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to study the effects of Paricalcitol (Zemplar) on kidney functioning. The investigators hypothesize that the increase in serum creatinine observed in recent paricalcitol trials is a function of reduced creatinine secretion and not an actual reduction in kidney function. 16 patients will have kidney function measured via iothalamate clearance at baseline, after 7 days of paricalcitol treatment and after 7 days of being washed off the paricalcitol.

Detailed description:

Arms: arm 1: After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
Interventions: intervention 1: Paricalcitol
Intervention descriptions: intervention 1: 2 mcg oral Paricalcitol once per day for 7 days

Protocol documents:
Clinical trial NCT01166763
Conditions: Breast Cancer
Keywords: breast atypia high risk for breast cancer random periareolar fine needle aspiration RPFNA breast epithelial hyperplasia ki-67 chemoprevention vitamin D3 Additional relevant MeSH terms: Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Breast Neoplasms Pharmacologic Actions Hyperplasia high risk for development of breast cancer Neoplasms Neoplasms by Site Pathologic Processes Antirheumatic Agents Breast Diseases
Sponsor: Carol Fabian, MD
Start date: 2009-05-01; Completion date: 2011-06-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The overall goal of this project is to determine if high dose vitamin D3 given to premenopausal women at high risk for development of breast cancer, who initially have insufficient levels of 25-hydroxy vitamin D (\<30 ng/ml), will raise 25(OH)D levels above 50 ng/ml. If so, will certain risk biomarkers for development of breast cancer be reliably and favorably modulated?

Detailed description:
Protocol Objectives:

To determine if high dose vitamin D3 given to premenopausal women who initially have insufficient levels of 25-hydroxy vitamin D (\<30 ng/ml) will raise 25(OH)D levels above the 50 ng/ml level considered to be required for breast health. If so, will certain risk biomarkers for development of breast cancer be reliably and favorably modulated? The primary endpoint will be a decrease in mammographic breast density (percent area considered at increased density). Change in proliferation (a decrease as assessed by Ki-67) will also be examined. Modulate of expression of genes important in breast cancer risk or reflective of vitamin D's mechanism of action will be studied using quantitative real time polymerase chain reaction (qRT-PCR).

Study Design:

The study is a single-arm open label clinical trial. Women who are high risk for development of breast cancer on the basis of family or personal history will undergo random periareolar fine needle aspiration (RPFNA) to acquire breast cells for assessment of gene expression by qRT-PCR. Women with mammographic density \>10% will be eligible for enrollment. All subjects will receive high dose vitamin D3 (3 capsules of 10,000 IU of vitamin D3 every week for 6-8 months). At that time, a repeat RPFNA and mammogram will be performed. Measurement of serum levels of 25(OH)D will be performed at baseline, 3 months, and 6 months.

Arms: arm 1: Group/Cohort Label vitamin D3
Interventions: intervention 1: vitamin D3
Intervention descriptions: intervention 1: oral capsules, 10,000 IU per week for 6 months

Protocol documents:
Clinical trial NCT01167023
Conditions: Sickle Cell Anemia
Keywords: Sickle Cell Disease Sickle Cell Anemia Adult
Sponsor: Eli Lilly and Company
Start date: 2010-07-01; Completion date: 2011-06-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to assess the safety of Prasugrel in adult patients with sickle cell disease (SCD) by monitoring the rate and severity of hemorrhagic events requiring medical intervention compared to placebo for 30 days.

Detailed description:

Arms: arm 1: Participants were to receive 7.5 milligrams (mg) of prasugrel orally, once daily if they weighed ≥60 kilograms (kg) and if pharmacodynamic (PD) measures indicated that the 5-mg prasugrel dose did not produce a steady-state PD response equivalent to inhibition of platelet activation (IPA) ≥25%. Because these criteria were not met, no participants received 7.5 mg of prasugrel. arm 2: None arm 3: None
Interventions: intervention 1: Prasugrel intervention 2: Placebo
Intervention descriptions: intervention 1: Administered orally, once daily for 30 days. intervention 2: Administered orally, once daily for 30 days.

Protocol documents:
Clinical trial NCT01181921
Conditions: Alzheimer Disease
Keywords: Alzheimer Disease Dementia Sleep Disorders Galantamine Reminyl
Sponsor: Janssen-Cilag, S.A.
Start date: 2011-05-01; Completion date: 2011-06-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the modulating effect of galantamine on circadian rhythm in patients with moderate Alzheimer's disease.

Detailed description:
This is a pilot, single-group, interventional, prospective study including patients with moderate Alzheimer's disease, treated with galantamine. Galantamine is thought to benefit the cognitive functioning of those with Alzheimer's disease. The starting treatment dose is 8 mg/day for 4 weeks. The initial maintenance dose of galantamine is 16 mg/day. Patients should be maintained on 16 mg/day for 4 weeks. An increase to the maintenance dose of 24 mg/day should be considered on an individual basis after the appropriate assessment including evaluation of clinical benefit and tolerability. For individual patients not showing an increased response or not tolerating 24 mg/day, a dose reduction to 16 mg/day should be considered. The primary objective is the assessment of the modulating effect of galantamine (Reminyl PRC) on circadian rhythm (wake/sleep) in patients with moderate Alzheimer's disease. The secondary objective is to assess the perception of the physicians, caregivers and patients themselves on sleep-wake disorders in patients with moderate Alzheimer's disease before and after treatment with galantamine. Sleep disturbances will be assessed by two actigraphy measures: one, before starting treatment, and the other, 12 weeks after the first actigraphic measure. The primary endpoint is the day/night ratio measured by the actigraphy before and after treatment with galantamine in patients with moderate Alzheimer-type dementia. Concerning the Efficacy Measures, the Actigraphy will be used as a method to assess the modulating effect of galantamine on circadian rate. The impact of this modulating effect on the caregivers, patients themselves and physicians will be assessed by three questionnaires: the Zarit Caregiver Burden Interview (ZBI), the Pittsburgh Sleep Quality Index (PSQI) and the Clinical Global Impression (CGI), respectively. Patient safety will be monitored. It is estimated that the study period will range from September 2010 to the second quarter of 2011.

Arms: arm 1: None
Interventions: intervention 1: Galantamine
Intervention descriptions: intervention 1: Type= range, unit= mg, number= 8-24, form= capsule, route= oral use. The starting dose will be 8 mg/day for 4 weeks. Subsequently, the initial maintenance dose will be 16 mg/day for 4 weeks. Then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.

Protocol documents:
Clinical trial NCT01195363
Conditions: Bipolar Disorder
Keywords: bipolar disorder, mania, depression
Sponsor: The University of Texas Health Science Center at San Antonio
Start date: 2007-04-01; Completion date: 2011-06-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the acute and long-term bimodal efficacy of QTP, as an adjunct to ongoing treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any combination of the three thereof, in a group of patients with an index episode of a mixed state in BD.

Detailed description:

Arms: arm 1: quetiapine SR, 200-600mg, po, qd arm 2: quetiapine SR placebo, 200-600mg, po qd
Interventions: intervention 1: quetiapine SR intervention 2: quetiapine sr placebo
Intervention descriptions: intervention 1: quetiapine SR, dose range 200-600mg, each night QHS for 6mos intervention 2: quetiapine sr placebo, dose range 200-600mg, each night QHS for 6mos

Protocol documents:
Clinical trial NCT01201317
Conditions: Neuropathic Pain
Keywords: Analgesic effect
Sponsor: AstraZeneca
Start date: 2010-09-01; Completion date: 2011-06-01
Enrollment: 134 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with painful diabetic polyneuropathy.

Detailed description:

Arms: arm 1: Tablets, 150 mg once daily in the morning. arm 2: Tablets, 20 mg once daily in the morning. arm 3: Tablets, placebo, once daily in the morning.
Interventions: intervention 1: AZD2423 intervention 2: AZD2423 intervention 3: Placebo
Intervention descriptions: intervention 1: 20 mg tablet intervention 2: 150 mg tablet intervention 3: Placebo

Protocol documents:
Clinical trial NCT01210560
Conditions: Autosomal Dominant Polycystic Kidney Disease
Keywords: Kidney Disease Polycystic Kidney Disease
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2010-10-01; Completion date: 2011-06-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To establish pharmacokinetics (PK), pharmacodynamics (PD), and adverse event (AE) profile of tolvaptan administered as the modified-release (MR) formulation in ADPKD subjects. The goals of this trial are two-fold:

1. To directly compare the immediate release (IR) and MR formulations
2. To determine the dose range and dose regimen for MR (dose finding)

Detailed description:
Group 1 will have 12 subjects enrolled in a 3-period, randomized, crossover to compare multiple doses of a 90-30 mg split-dose of the tolvaptan IR formulation, a 120 mg once daily (QD) dose of the tolvaptan MR formulation, and, in an incomplete block randomization, multiple doses of either 20 mg QD, 60 mg QD, or 20 mg twice daily (BID) tolvaptan MR formulation. All dose regimens will be administered for 7 days. Placebo doses will be administered in order to mask QD vs BID treatments.

Group 2 will have 12 subjects enrolled in a 3-period, randomized, crossover to compare multiple oral doses of the tolvaptan MR formulation administered for 7 days as 20 mg QD, 60 mg QD, and 20 mg BID. Placebo capsules will be administered in order to mask QD vs BID treatments.

Subjects will have in-clinic assessments on 12 days to obtain 24-hour PK and PD data. Subjects will visit the clinic from the afternoon of Day -1 through the morning of Day 1. They will return at the end of each dosing period for a similar inpatient period (ie, from the afternoon of Day 6 through the morning of Day 8, from the afternoon of Day 13 through the morning of Day 15, from the afternoon of Day 20 through the morning of Day 22). Except for the first dose of each period and the doses taken in the clinic on the last day of each regimen and the afternoon of Days 6, 13 and 20, all other doses will be taken by the subject as an outpatient.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Tolvaptan MR intervention 2: Tolvaptan MR intervention 3: Tolvaptan MR intervention 4: Tolvaptan IR intervention 5: Tolvaptan MR
Intervention descriptions: intervention 1: 20 mg Tolvaptan MR capsule(morning); Placebo capsules/tablets (morning and afternoon) for 7 days intervention 2: 20 mg Tolvaptan MR capsule(morning and afternoon); Placebo capsules/tablets (morning and afternoon) for 7 days intervention 3: 60 mg Tolvaptan MR capsule(morning); Placebo capsules/tablets (morning and afternoon) for 7 days intervention 4: 90 mg Tolvaptan IR tablet(morning); 30 mg Tolvaptan IR tablet (afternoon); Placebo capsules (morning and afternoon) for 7 days intervention 5: 120 mg Tolvaptan MR capsule(morning); Placebo capsules/tablets (morning and afternoon) for 7 days

Protocol documents:
Clinical trial NCT01218100
Conditions: Stage 2 Diastolic Hypertension
Sponsor: Forest Laboratories
Start date: 2010-10-01; Completion date: 2011-06-01
Enrollment: 664 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of first-line treatment with a free combination (as two separate pills) of nebivolol and lisinopril in patients with stage 2 diastolic hypertension (DBP\>= 100 mmHg).

Detailed description:

Arms: arm 1: Combination group - starting dose level nebivolol 5mg and lisinopril 10mg arm 2: Nebivolol monotherapy group - starting dose level nebivolol 5mg arm 3: Lisinopril monotherapy group - starting dose level lisinopril 10mg arm 4: Placebo group - starting dose is placebo
Interventions: intervention 1: nebivolol and lisinopril (free combination) intervention 2: nebivolol monotherapy intervention 3: lisinopril monotherapy intervention 4: placebo
Intervention descriptions: intervention 1: nebivolol 5-mg and lisinopril 10-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 10-mg tablet)/QD/oral administration/up to 12 weeks

nebivolol 20-mg and lisinopril 40-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 10 weeks

nebivolol 5-mg and lisinopril 40-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 6 weeks

nebivolol 20-mg and lisinopril 10-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 10-mg tablet/QD/oral administration/up to 6 weeks intervention 2: nebivolol 5-mg (non-trade 5-mg tablet)/QD/oral administration/up to 12 weeks

nebivolol 10-mg (non-trade 10-mg tablet/QD/oral administration/for 1-week down-titration period only)

nebivolol 20-mg (non-trade 20-mg tablet)/QD/oral administration/up to 10 weeks intervention 3: lisinopril 10-mg (overencapsulated 10-mg tablet)/QD/oral administration/up to 12 weeks lisinopril 40-mg (overencapsulated 40-mg tablet)/QD/oral administration/up to 10 weeks intervention 4: Placebo tablet, oral administration/QD/oral administration/up to 12 weeks Placebo capsule, oral administration/QD/oral administration/up to 12 weeks

Protocol documents: