ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00515086
Conditions: Glioblastoma Multiforme
Keywords: Glioblastoma Multiforme, GBM, RAD001, RAD
Sponsor: Novartis Pharmaceuticals
Start date: 2007-08-01; Completion date: 2009-08-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will define the safety and efficacy of Everolimus (RAD001) administered daily in patients with glioblastoma multiforme (GBM)

Detailed description:
This was a multicenter, open label, randomized study of RAD001 dosed daily in patients with recurrent GBM. The study was conducted with 2 parallel groups of patients. Group 1 was designed to study the biological effects of RAD001 in patients scheduled to undergo salvage surgical resection, and Group 2 was to enroll patients who were not scheduled for surgery. Patients in Group 1 were randomly assigned to one of three pre-surgery treatment groups (0, 5 or 10 mg/day RAD001 for 7 days). All patients in Group 2 were to receive a fixed daily dose of 10 mg/day oral RAD001.

Arms: arm 1: Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity. arm 2: Participants scheduled to undergo salvage surgical resection received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity. arm 3: Participants scheduled to undergo salvage surgical resection received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity. arm 4: Participants scheduled to undergo salvage surgical resection received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
Interventions: intervention 1: Everolimus intervention 2: Surgery
Intervention descriptions: intervention 1: Tablets taken once a day with a full glass of water. intervention 2: Salvage surgical resection

Protocol documents:
Clinical trial NCT00515203
Conditions: Idiopathic Thrombocytopenic Purpura Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Keywords: Immune (Idiopathic) Thrombocytopenic Purpura Pediatric Idiopathic Thrombocytopenic Purpura
Sponsor: Amgen
Start date: 2007-07-01; Completion date: 2009-08-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of romiplostim (AMG 531) in the treatment of thrombocytopenia in pediatric subjects with chronic ITP. We will also evaluate the efficacy of romiplostim (AMG 531) and characterize the pharmacokinetics of romiplostim (AMG 531). It is anticipated that romiplostim (AMG 531), when given at an effective dose and schedule, will be well tolerated treatment for thrombocytopenia among pediatric subjects with chronic ITP.

Detailed description:

Arms: arm 1: 5 thrombocytopenic (as defined per protocol) subjects arm 2: 15 thrombocytopenic (as defined per protocol) subjects
Interventions: intervention 1: Placebo intervention 2: AMG 531
Intervention descriptions: intervention 1: Starting dose of 1.0 ug/kg. Dose adjustments are made throughout the study based on individual platelet counts. intervention 2: Starting dose of 1.0 ug/kg. Dose adjustments are made throughout the study based on individual platelet counts.

Protocol documents:
Clinical trial NCT00521365
Conditions: Bipolar Disorder Bipolar Affective Psychosis Mania Manic Disorder Manic State
Keywords: Bipolar Disorder Bipolar Affective Psychosis Mania Manic Disorder Manic State
Sponsor: AstraZeneca
Start date: 2008-05-01; Completion date: 2009-08-01
Enrollment: 88 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of the study is to assess the efficacy of Quetiapine extended release 600mg per day either as monotherapy or combined therapy in the treatment of patients with mania associated to Bipolar disorder. This trial will also assess the life quality and productivity loss improvement for patients from baseline to day 21.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Quetiapine 600mg
Intervention descriptions: intervention 1: 300 mg quetiapine fumarate tablets for oral use.

Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.

Protocol documents:
Clinical trial NCT00522873
Conditions: Postmenopause
Keywords: Postmenopausal Symptoms e.g. Hot flushes Sweating episodes Vaginal dryness
Sponsor: Bayer
Start date: 2007-08-01; Completion date: 2009-08-01
Enrollment: 662 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).

Detailed description:

Arms: arm 1: One capsule \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 13 cycles (28 days per cycle). arm 2: One capsule \[0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)\] per day taken orally for 13 cycles (28 days per cycle).
Interventions: intervention 1: 0.25mg DRSP / 0.5mg E2 (BAY86-4891) intervention 2: 0.5mg NETA / 1.0mg E2 (Activella)
Intervention descriptions: intervention 1: One capsule \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 13 cycles (28 days per cycle). intervention 2: One capsule \[0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)\] per day taken orally for 13 cycles (28 days per cycle).

Protocol documents:
Clinical trial NCT00536107
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-Small Cell Lung Cancer Locally Advanced or Metastatic NSCL Cancer
Sponsor: AstraZeneca
Start date: 2007-10-01; Completion date: 2009-08-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, open- label, parallel group, phase IV, multicentre study. The total number of patients expected to be recruited is 40. These randomized patients will have a histologically or cytologically confirmed adenocarcinoma histology of locally advanced or metastatic NSCLC. Patients will be recruited by investigational sites that have expertise in treating patients with non-small cell lung cancer. The study will compare gefitinib monotherapy 250 mg/day orally with docetaxel 60 mg/m2 intravenously over 1 hour every 3 weeks with a primary endpoint of safety and tolerability. The target population will be patients who have received one prior platinum-based chemotherapy and are now considered suitable candidates for further chemotherapy with docetaxel. At study entry, patients will be randomized on a 1:1 basis stratified with respect to performance status (0-1 vs. 2). Patients may continue to receive treatment with either gefitinib or docetaxel until disease progression, unacceptable toxicity or the occurrence of any of the other specific criteria. An independent committee will be appointed to perform a blinded review of all patient scans. Any assessments/visits after screening should be performed within a window of plus or minus 3 working days of the scheduled visit date. If selected screening evaluations are done within 7 days of Day 1, Cycle 1 of treatment, and are acceptable for study entry, they do not have to be repeated on Day 1 unless the investigator believes that they are likely to have significantly changed. Any patient who discontinues from study treatment without radiological evidence of disease progression (except for withdrawal of consent by patient) should continue to have objective tumor assessments every 6 weeks in order to collect information on progression of disease

Detailed description:

Arms: arm 1: docetaxel arm 2: Gefitinib (IRESSA)
Interventions: intervention 1: Gefitinib intervention 2: CT or MRI intervention 3: Docetaxel
Intervention descriptions: intervention 1: 250 mg oral intervention 2: performed at screening and every 6 weeks intervention 3: 60mg/m2 intravenous infusion

Protocol documents:
Clinical trial NCT00548808
Conditions: Type 2 Diabetes Mellitus
Sponsor: Eli Lilly and Company
Start date: 2007-11-01; Completion date: 2009-08-01
Enrollment: 426 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the insulin lispro low mixture (1, 2 or 3 daily injections) with insulin glargine (alone or with 1, 2 or 3 insulin lispro daily injections) on lowering the blood sugar level

Detailed description:

Arms: arm 1: Insulin lispro low mixture (1, 2 or 3 daily injections) arm 2: Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
Interventions: intervention 1: Insulin lispro low mixture intervention 2: Insulin glargine intervention 3: Insulin lispro
Intervention descriptions: intervention 1: Dose depending on patient's need; subcutaneous injection before meal; start with once-daily injection before evening meal for 48 weeks, may add second injection before breakfast at any time during the treatment period if required, and may further add third injection before lunch at any time in the remainder of the treatment period if required. intervention 2: Dose depending on patient's need; one daily subcutaneous injection before bedtime for 48 weeks intervention 3: Dose depending on patient's need; subcutaneous injection before meal; may start once-daily injection before meal (e.g. lunch if the highest blood glucose value is measured before dinner) on top of insulin glargine at any time of the treatment period if required, and may further add second or even third injection in the remainder of the treatment period if required.

Protocol documents:
Clinical trial NCT00567320
Conditions: Cocaine Dependence Nicotine Dependence
Keywords: varenicline
Sponsor: Yale University
Start date: 2007-03-01; Completion date: 2009-08-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Cocaine addiction continues to be an important public health problem in the US with a significant cost to the individual and society. Among substance abusers, cocaine use has been recognized as a significant problem especially in methadone-maintenance patients. In several studies, rates of cocaine use have been reported to range from 30 to over 60 percent of those in methadone maintenance programs (Condelli et al. 1991; Hunt et al. 1984; Kidorf and Stitzer 1993; Kosten et al. 1988). In these patients, cocaine use seems to be a predictor of poor clinical outcome (Hartel et al. 1995; Kosten et al. 1987a). The development of effective pharmacotherapies for cocaine use disorders, especially in the opioid-dependent population is of great importance. Unfortunately, such effective pharmacotherapies do not exist.

1. To determine the safety and tolerability of varenicline in cocaine-using methadone-stabilized subjects.
2. To determine if varenicline is efficacious in reducing cocaine-use in methadone-stabilized subjects.

Detailed description:
For this pilot study, we hope to recruit a total of 40 subjects, with 20 subjects in the varenicline group, and 20 into the placebo-control group. Assuming significant findings, these data will enable us to estimate a possible effect size for carrying-out a larger study. For preliminary analysis as a prelude to planning larger controlled studies, we will clinically require an effect size of 20% differences in the rates of cocaine positive urines or of self-reported cocaine use between the active medication and placebo groups. We will not adjust for these multiple comparisons to the placebo group since this is a pilot study, and use two-tailed significance level of 0.05 when we employ repeated measures analysis of variance (ANOVA) or Hierarchical Linear Modeling (HLM,see below) for statistical analysis over the 16-week study period.

An Amendment was made and a new Updated consent form to include new FDA findings for study medication Varenicline." Varenicline may also cause changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior." Currently we have 30 subjects who have completed this study. This study is suspended due to these new concerns, Department of Veterans Affairs and the P.I. James Poling agreed.

Study has been published. (April 2011)

Arms: arm 1: None arm 2: Placebo is compared to active drug varenicline
Interventions: intervention 1: Varenicline intervention 2: Sugar pill or Placebo
Intervention descriptions: intervention 1: Varenicline up to 2 mg a day intervention 2: Placebo

Protocol documents:
Clinical trial NCT00568087
Conditions: Alcoholism
Keywords: N-acetylcysteine Alcoholism Treatment
Sponsor: Minneapolis Veterans Affairs Medical Center
Start date: 2007-12-01; Completion date: 2009-08-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The present study is designed to find out if N-acetylcysteine works in reducing alcohol drinking and craving.

Detailed description:
The 2 groups (placebo and N-acetylcysteine) will be compared in a double-blind, placebo-controlled trial. The total study duration is 9 weeks which includes a 1-week screening period and an 8-week randomized study drug treatment period.

Arms: arm 1: Patients will take oral N-acetylcysteine 900 mg/day for 1 week, 1800 mg/day for 1 week, 2700 mg/day for 1 week, and then 3600 mg/day. arm 2: Patients will take oral placebo (identical matching placebo) during the study period.
Interventions: intervention 1: N-acetylcysteine intervention 2: Placebo
Intervention descriptions: intervention 1: Patients will take oral N-acetylcysteine 900 mg/day for 1 week, 1800 mg/day for 1 week, 2700 mg/day for 1 week, and then 3600 mg/day. intervention 2: Patients will take oral placebo (identical matching placebo) during the study period.

Protocol documents:
Clinical trial NCT00573170
Conditions: Migraine Disorders Migraine, Acute
Keywords: Migraine, acute Migraine Butalbital-containing Combination Medication (BCM) Naproxen sodium Sumatriptan succinate TREXIMET®
Sponsor: GlaxoSmithKline
Start date: 2008-02-01; Completion date: 2009-08-01
Enrollment: 375 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Study TRX109011/TRX109013, A Randomized, Double-blind, Double-dummy, Placebo-controlled, Crossover Study to Evaluate the Efficacy of TREXIMET® (Sumatriptan + Naproxen Sodium) versus Butalbital-containing Combination Medications (BCM) for the Acute Treatment of Migraine when administered during the Moderate-Severe Pain Phase of the Migraine (Studies 1 and 2 of 2)

Detailed description:
This study is a multicenter, randomized, double-blind, double-dummy, placebo-controlled, crossover, three-attack, outpatient study in which TREXIMET® will be compared to a butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg \[Fioricet\]) for the acute treatment of migraine headaches. Subjects will be randomized to one of 6 possible treatment sequences (TPB, TBP, BTP, BPT, PTB, PBT where T = TREXIMET®; P = Placebo; B = Butalbital-containing Combination Medication) . Subjects will treat each of the 3 migraine attacks when pain is moderate to severe. The study will include 4 visits: (1) a Screening visit at study entry, (2) a Drug Screen visit, (3) a Randomization visit, and (4) a Final visit. The Final visit occurs either (A) upon withdrawal or (B) after treatment of 3 migraine attacks. The primary objective is to evaluate the efficacy of TREXIMET® versus BCM for the acute treatment of moderate/severe migraine. These two replicate studies were amended while ongoing to allow for the reporting of pooled data only.

Arms: arm 1: TREXIMET® (Attack 1), placebo (Attack 2), BCM (Attack 3) arm 2: TREXIMET® (Attack 1), BCM (Attack 2), placebo (Attack 3) arm 3: BCM (Attack 1), TREXIMET® (Attack 2), placebo (Attack 3) arm 4: BCM (Attack 1), placebo (Attack 2), TREXIMET® (Attack 3) arm 5: placebo (Attack 1), TREXIMET® (Attack 2), BCM (Attack 3) arm 6: placebo (Attack 1), BCM (Attack 2), TREXIMET® (Attack 3)
Interventions: intervention 1: TREXIMET® intervention 2: Butalbital-containing Combination Medications (BCM) intervention 3: placebo
Intervention descriptions: intervention 1: Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate \[equivalent to sumatriptan 85mg\] and naproxen sodium 500mg) intervention 2: butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) \[currently marketed as Fioricet\] intervention 3: placebo

Protocol documents:
Clinical trial NCT00573430
Conditions: Non-diabetic Nephropathy With Hypertension
Keywords: Candesartan Cilexetil Non-diabetic Nephropathy hypertension urine protein creatinine ratio
Sponsor: AstraZeneca
Start date: 2007-12-01; Completion date: 2009-08-01
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the effective dose of candesartan cilexetil for reduction of urinary protein excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in urinary protein/creatinine ratio from baseline to the end of 28-week treatment

Detailed description:

Arms: arm 1: Candesartan Cilexetil arm 2: Candesartan Cilexetil arm 3: Candesartan Cilexetil
Interventions: intervention 1: Candesartan Cilexetil intervention 2: Candesartan Cilexetil intervention 3: Candesartan Cilexetil 32mg
Intervention descriptions: intervention 1: 8 mg oral once daily dose intervention 2: 16 mg oral once daily dose intervention 3: 32 mg oral once daily dose

Protocol documents:
Clinical trial NCT00599053
Conditions: Bacteria Infection Respiratory Tract Infections
Keywords: Ureaplasma Bronchopulmonary dysplasia very low birthweight
Sponsor: University of Alabama at Birmingham
Start date: 2007-05-01; Completion date: 2009-08-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Our hypothesis is that treatment of known Ureaplasma spp. infection of the airways in very low birth weight (VLBW) infants with azithromycin will eradicate the organisms and lessen the proinflammatory state caused by infection that puts them at risk for Bronchopulmonary Dysplasia (BPD). We propose to conduct a randomized trial of early (less than 3 days of age) treatment with intravenous azithromycin versus expectant management for VLBW infants with Ureaplasma spp. respiratory tract infection with the following specific aims: (1) Determine microbiological efficacy, pharmacokinetics, and safety of azithromycin treatment for eradication of Ureaplasma spp. in preterm infants, (2) Determine the respiratory outcomes of infants in the two treatment groups and those without respiratory tract Ureaplasma spp. infection

Detailed description:

Arms: arm 1: Early treatment with azithromycin arm 2: Expectant (usual) management
Interventions: intervention 1: Azithromycin
Intervention descriptions: intervention 1: 10 mg/kg IV per dose given for 10 days

Protocol documents:
Clinical trial NCT00603044
Conditions: Childhood Obstructive Sleep Apnea Syndrome (OSAS)
Sponsor: University of Chicago
Start date: 2008-01-01; Completion date: 2009-08-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research is to find out how a nasal spray (fluticasone furoate), sometimes given to children with obstructive sleep apnea syndrome (OSAS), works on certain cells within a child's adenoids. We hypothesize that intranasal steroids lead to an upregulation of T regulatory cells in the adenoid tissues of children with OSAS. This will result in a local reduction in inflammation and edema explaining the improvement in OSAS.

Detailed description:
The objective was to determine the effect of intranasal corticosteroid therapy on T-regulatory cells and other inflammatory cytokines in adenoid tissues in children with obstructive sleep apnea syndrome.Children were randomized to either no treatment or treatment with fluticasone furoate nasal spray, 55 μg/nostril daily, for 2 weeks before adenotonsillectomy. Adenoid tissue was obtained at the time of the procedure.

Arms: arm 1: 55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy arm 2: None
Interventions: intervention 1: fluticasone furoate
Intervention descriptions: intervention 1: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy

Protocol documents:
Clinical trial NCT00603902
Conditions: Obesity
Keywords: Obesity Weight loss lorcaserin APD356 BLOSSOM Hypertension Dyslipidemia Sleep apnea glucose tolerance cardiovascular disease Arena
Sponsor: Eisai Inc.
Start date: 2008-01-01; Completion date: 2009-08-01
Enrollment: 4008 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients.

Detailed description:
Randomized, double-blind, placebo-controlled, parallel-group assessment of the effects of lorcaserin hydrochloride during 52 weeks of administration to overweight or obese male and female volunteers aged 18 to 65 years inclusive.

Arms: arm 1: Lorcaserin 10 mg tablet each morning and placebo tablet each evening arm 2: Lorcaserin 10 mg tablet each morning and evening arm 3: Matching placebo tablet each morning and evening
Interventions: intervention 1: Lorcaserin 10 mg once daily (QD) intervention 2: Lorcaserin 10 mg twice a day (BID) intervention 3: Matching Placebo
Intervention descriptions: intervention 1: Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks. intervention 2: Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks. intervention 3: Matching placebo tablet each morning and evening for a duration of 52 weeks.

Protocol documents:
Clinical trial NCT00611468
Conditions: Metastatic Solid Tumor
Sponsor: Accelerated Community Oncology Research Network
Start date: 2006-06-01; Completion date: 2009-08-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to determine the best dose of the combination of two approved drugs, intravenous topotecan and oral erlotinib.

Detailed description:
The primary objectives of this trial include:

* To determine the maximum tolerated dosage (MTD) of intravenous topotecan when given in combination with oral erlotinib.
* To define the dosage-limiting toxicities (DLT) of this combination.
* To evaluate the pharmacokinetic (PK) parameters of intravenous topotecan with and without erlotinib

The secondary objectives include:

* To evaluate the pharmacodynamic effect of the topotecan and erlotinib combination
* To evaluate for any correlations between the presence of CYP3A4/5 polymorphisms and topotecan / erlotinib disposition and to measure the frequency of MDR1 and BCRP in peripheral blood samples and correlate these results with topotecan pharmacokinetics
* To measure the frequency of UGT genotypes in peripheral blood samples
* To evaluate the objective response rate using the RECIST criteria.

Arms: arm 1: All subjects receive treatment with intravenous topotecan and oral erlotinib.
Interventions: intervention 1: Topotecan intervention 2: Erlotinib
Intervention descriptions: intervention 1: All subjects receive treatment with intravenous topotecan and oral erlotinib. intervention 2: All subjects receive treatment with intravenous topotecan and oral erlotinib.

Protocol documents: