ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01018264
Conditions: Overactive Bladder in Parkinson's Disease
Keywords: Overactive bladder Urinary incontinence Urinary frequency Parkinson's disease
Sponsor: University of South Florida
Start date: 2010-01-01; Completion date: 2014-08-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the effectiveness of solifenacin succinate (VESIcare) in reducing symptoms of overactive bladder in Parkinson's disease (PD) patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: solifenacin succinate (VESIcare) intervention 2: placebo
Intervention descriptions: intervention 1: up to 10mg every day orally intervention 2: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day

Protocol documents:
Clinical trial NCT01018992
Conditions: Stress Disorders, Post-Traumatic
Keywords: PTSD Anxiety Disorder Corticotropin releasing factor Women
Sponsor: Emory University
Start date: 2009-12-01; Completion date: 2014-08-01
Enrollment: 267 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the hypothesis of whether an antagonist at the corticotropin releasing factor type 1 (CRF1) receptor (i.e. GSK561679) is superior to placebo in reducing symptoms of post-traumatic stress disorder (PTSD).

Detailed description:
Post-traumatic stress disorder (PTSD) is a chronic and common anxiety disorder that follows exposure to an overwhelming traumatic event. The majority of patients with PTSD also meet criteria for other psychiatric disorders and PTSD is associated with an increased risk for suicide attempts.

PTSD is responsive to psychological and pharmacological treatments, such as selective serotonin reuptake inhibitors (SSRIs), but response rates rarely exceed 60%, and even fewer patients (20-30%) achieve clinical remission. Thus, there is a clear need to develop novel and improved therapeutics for PTSD.

The study is divided into 4 phases:

Phase 1 (Screening): a 1 week no drug screening period to assess study eligibility.

Phase 2 (Pre-Treatment Testing Period): Eligible patients will be enrolled into a 1 week Testing Phase, which will include neuropsychological and neurophysiological testing as well as blood draws and electrocardiogram.

Phase 3 (Treatment Period): Eligible patients will be enrolled in a two-armed 6-week period of double-blind placebo-controlled acute treatment. All subjects who continue to meet eligibility criteria will be randomized to one of two groups: GSK561679 (at a fixed dose of 350 mg/day) or placebo. Randomization will be performed at a 1:1 ratio into two treatment groups. Neuropsychological and neurophysiological testing will be repeated after 5 weeks of the double-blind treatment period.

Phase 4 (Follow-up Period): Safety follow-up visits will be conducted 1 week and 1 month after the end of the treatment Phase 3.

Arms: arm 1: Adult women with DSM-IV defined PTSD will receive matching placebo for 6 weeks arm 2: Adult women with DSM-IV-defined PTSD will receive GSK561679 at a fixed dose of 350 mg/day for 6-weeks
Interventions: intervention 1: GSK561679 intervention 2: Placebo
Intervention descriptions: intervention 1: GSK561679, oral administration, 350mg/day, 6 week administration intervention 2: Matching placebo, oral administration, 1 pill/day for 6 weeks

Protocol documents:
Clinical trial NCT01026402
Conditions: Advanced Solid Malignancies
Keywords: Phase I cancer advanced solid malignancies dose escalation AZD2014 mTor kinase inhibitor safety pharmacokinetics
Sponsor: AstraZeneca
Start date: 2009-12-01; Completion date: 2014-08-01
Enrollment: 172 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of the study is to establish a safe dose of the drug by providing information on any potential side effects this drug may cause and collecting data about how a patient's cancer responds to the drug. The study will also assess the blood levels and action of AZD2014 in the body over a period of time and will indicate whether the drug has an effect on the types of cancer the patients have.

Detailed description:

Arms: arm 1: AZD2014 dose escalation phase in Part A and expansion phase in Part B.
Interventions: intervention 1: AZD2014
Intervention descriptions: intervention 1: Dose escalation phase: a single dose taken orally (solution or tablet) of AZD2014 on single dose day 1 (visit 2), followed by once or twice daily continuous dosing after a washout period (48 hours - 7 days) at visit 4, until discontinuation or withdrawal or Single or multiple doses taken orally (solution or tablet) of AZD2014 taken intermittently until discontinuation or withdrawal. Expansion phase: twice daily dosing from day 1 until discontinuation or withdrawal or a single dose taken orally of AZD2014 on single dose day 1 (visit 2), followed by a single dose on second single dose day 1 (visit 3) after a washout period (48 hours - 7 days) followed by once or twice daily continuous dosing after a washout period (48 hours - 7 days) at visit 4, until discontinuation or withdrawal or single or multiple doses taken orally (solution or tablet) of AZD2014 taken intermittently until discontinuation or withdrawal.

Protocol documents:
Clinical trial NCT01027806
Conditions: Obstructive Sleep Apnea
Keywords: Children Sleep Obstructive Sleep Apnea
Sponsor: University of Chicago
Start date: 2010-07-01; Completion date: 2014-08-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators leading hypotheses are:

* Oral therapy with montelukast may lead to improved sleep study findings in children with mild to moderate Obstructive Sleep Apnea Syndrome (OSAS) who require surgical removal of adenoids and tonsils for OSAS.
* A significant proportion of the children with OSAS treated with montelukast will show reduced severity of OSAS, and this will remove the need for surgical intervention.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Montelukast
Intervention descriptions: intervention 1: 1 pill per day for 4 months

Protocol documents:
Clinical trial NCT01044693
Conditions: Hypertension Pure Autonomic Failure Multiple System Atrophy
Keywords: supine Hypertension autonomic failure nitric oxide nebivolol
Sponsor: Vanderbilt University
Start date: 2010-01-01; Completion date: 2014-08-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the effect of the antihypertensive drug, nebivolol (Bystolic), compared to metoprolol (Lopressor) and sildenafil (Viagra) on blood pressure in patients with autonomic failure and supine hypertension.

Detailed description:
Nebivolol is distinct among beta-blockers by its ability to increase nitric oxide (NO) bioactivity. The contribution of this effect to the pharmacological actions of the drug, however, is difficult to ascertain in normal subjects because of the confounding contribution of the autonomic nervous system. Autonomic failure patients provide a unique model of hypertension devoid of autonomic modulation but sensitive to NO mechanisms. We propose to determine the effect of nebivolol on blood pressure in this patient population. A decrease in blood pressure will imply increased bioactivity of NO. Comparisons will be made with placebo, metoprolol (as a negative control) and sildenafil (as a positive control).

Arms: arm 1: Placebo capsule arm 2: Nebivolol 5 mg capsule arm 3: Metoprolol tartrate 50 mg single oral dose arm 4: Sildenafil 25 mg single oral dose
Interventions: intervention 1: Placebo intervention 2: Nebivolol 5 mg intervention 3: metoprolol tartrate 50 mg intervention 4: Sildenafil25 mg
Intervention descriptions: intervention 1: Placebo capsule intervention 2: Nebivolol 5mg single oral dose intervention 3: metoprolol tartrate 50 mg single oral dose intervention 4: Sildenafil 25 mg single oral dose

Protocol documents:
Clinical trial NCT01054079
Conditions: Adenocarcinoma of the Prostate Recurrent Prostate Cancer
Sponsor: Wake Forest University Health Sciences
Start date: 2011-09-01; Completion date: 2014-08-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well cinacalcet hydrochloride works in treating men with recurrent prostate cancer. Cinacalcet hydrochloride may be effective in lowering prostate-specific antigen (PSA) levels in patients with recurrent prostate cancer that has not responded to previous treatment

Detailed description:
PRIMARY OBJECTIVES:

I. To test the hypothesis that once-daily treatment with 30 mg of cinacalcet hydrochloride (Sensipar) will reduce the rate of rise of serum prostate-specific antigen (PSA) compared to pre-treatment PSA values in subjects with biochemically recurrent prostate cancer after failed definitive local therapy.

OUTLINE:

Patients receive cinacalcet hydrochloride orally (PO) once daily (QD) for 20 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Arms: arm 1: Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: laboratory biomarker analysis intervention 2: quality-of-life assessment intervention 3: questionnaire administration intervention 4: cinacalcet hydrochloride
Intervention descriptions: intervention 1: Correlative study intervention 2: Ancillary study intervention 3: Ancillary study intervention 4: Given PO

Protocol documents:
Clinical trial NCT01090011
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Boehringer Ingelheim
Start date: 2010-03-01; Completion date: 2014-08-01
Enrollment: 171 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this trial is to determine the maximum tolerated dose (MTD) and recommended Phase II doses for the combination of BIBW 2992 and cetuximab in patients with non-small cell lung cancer and acquired resistance to erlotinib or gefitinib.

Overall safety, pharmacokinetics and anti-tumor activity for the combination of BIBW 2992 and cetuximab in patients with non-small cell lung cancer and acquired resistance to erlotinib, gefitinib or BIBW 2992 will be evaluated as secondary objectives.

Initially a standard, 3+3 dose escalation will be performed to determine the MTD of BIBW 2992 when administered together with cetuximab in patients with advanced non small cell lung cancer and acquired resistance to erlotinib or gefitinib.

Subsequently, the preliminary efficacy and safety of the identified MTD of cetuximab administered with BIBW 2992 will be explored in a combo arm via a further expansion of MTD cohort up to a total of 140 EGFR mutation positive NSCLC with acquired resistance to erlotinib/gefitinib.

Furthermore, the safety and preliminary anti-tumor activity of the combination therapy in EGFR mutant NSCLC patients who developed acquired resistance (AR) to BIBW 2992, will be assessed in a sequential arm. The sequential arm will use a two-stage design with an early stopping rule after 12 patients with acquired resistance to BIBW 2992 have received up to 5 courses of BIBW 2992 plus cetuximab. If no responses are seen in 12 patients during 5 courses of combination therapy, accrual in the sequential arm will stop. If 1 or more responses are observed, the sequential arm will expand up to about 40 patients.

Detailed description:

Arms: arm 1: patients to receive medium BIBW 2992 once daily plus biweekly cetuximab infusion at low, median and high dose level arm 2: patients to receive BIBW 2992 once daily, upon progression add biweekly cetuximab
Interventions: intervention 1: Cetuximab intervention 2: Cetuximab intervention 3: BIBW 2992 intervention 4: BIBW 2992
Intervention descriptions: intervention 1: BIBW 2992 medium dose plus high dose level of cetuximab intervention 2: BIBW 2992 medium dose monotherapy, upon progression, cetuximab high dose is added intervention 3: BIBW 2992 medium dose plus high dose level of cetuximab intervention 4: BIBW 2992 medium dose monotherapy, upon progression, cetuximab high dose is added

Protocol documents:
Clinical trial NCT01124864
Conditions: Non-small-cell Lung Cancer
Keywords: Non-small-cell lung cancer HSP90 2nd to 3rd line treatment
Sponsor: Novartis Pharmaceuticals
Start date: 2010-10-01; Completion date: 2014-08-01
Enrollment: 153 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the efficacy of AUY922, when administered weekly at 70 mg/m2, in adult patients with advanced Non-small-cell Lung Cancer (NSCLC), who have received at least two prior lines of chemotherapy. Patients will be retrospectively, and prospectively, stratified based on their molecular tumor etiology. The following strata was assigned: Patients with Epidermal growth factor receptor (EGFR) activating mutations, Patients with Kirstin Raus sarcoma virus (KRAS) activating mutations, Patients with EML4-ALK (anaplastic lymphoma kinase) translocations and patients that were both EGFR and Kras wild type.

Detailed description:

Arms: arm 1: Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m\^2 weekly infusions. arm 2: Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m\^2 weekly infusions. arm 3: Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m\^2 weekly infusions. arm 4: Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m\^2 weekly infusions. arm 5: The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m\^2 weekly infusions.
Interventions: intervention 1: AUY922
Intervention descriptions: intervention 1: AUY922 was supplied in individual 10 mL amber colored glass ampoules containing 10 mL of a 5 mg/mL active drug substance in 5% aqueous glucose solution. AUY922 was administered intravenously (i.v.) weekly at 70 mg/m2.

Protocol documents:
Clinical trial NCT01132664
Conditions: Metastatic Breast Cancer HER2+ Breast Cancer
Keywords: HER2 BKM120 PIK3 metastatic breast cancer brain metastases Herceptin trastuzumab capecitabine open-label maximum tolerated dose Phase I/Phase ll
Sponsor: Novartis Pharmaceuticals
Start date: 2010-05-01; Completion date: 2014-08-01
Enrollment: 72 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the safety and efficacy of BKM120 in combination with trastuzumab in patients with relapsing HER2 overexpressing breast cancer who have previously failed trastuzumab.

The study will further assess the safety and preliminary efficacy of BKM120 in combination with trastuzumab and capecitabine in patients with relapsing HER2 overexpressing breast cancer and brain metastases (BM) who have previously failed trastuzumab.

Detailed description:

Arms: arm 1: Patients with HER2-overexpressing metastatic breast cancer, with or without PIK3 signaling pathway alteration, who have previously failed trastuzumab arm 2: Patients with HER2-overexpressing metastatic breast cancer and brain metastases, with or without PIK3 signaling pathway alteration, who have previously failed trastuzumab
Interventions: intervention 1: BKM120 intervention 2: Trastuzumab intervention 3: Capecitabine
Intervention descriptions: intervention 1: Buparlisib (BKM120) is the investigational drug. Burparlisib was supplied as 10 mg and 50 mg hard gelatin capsules. Buparlisib was dosed on a flat scale of mg/day and not adjusted to body weight or body surface area. Buparlisib capsules were packaged in high density polyethylene bottles with a plastic child resistant closure. intervention 2: Trastuzumab was used in this study according to the local regulations in each participating country. A loading dose (4 mg/kg) of trastuzumab was administered (if required as assessed by the principal Investigator based on the timing of the last trastuzumab dose prior to enrollment) on Day -7 over 90 minutes, followed by weekly intravenous infusion of 2 mg/kg maintenance doses from Day 1 of Cycle 1 (over 30 minutes if the previous infusion was well tolerated). intervention 3: 1000 mg/m2 twice a day from day 1 to Day 14 of a 21-day cycle.

Protocol documents:
Clinical trial NCT01144403
Conditions: Diffuse Large B-Cell Lymphoma
Sponsor: Hoffmann-La Roche
Start date: 2010-06-01; Completion date: 2014-08-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This multicenter, open-label study will assess the efficacy and safety of MabThera (rituximab) added to standard chemotherapy in participants with untreated Mantle Cell Lymphoma not eligible for autologous stem cell transplantation. Participants will receive MabThera (372 mg/m\^2 intravenously) on Day 1 of each 28-day treatment cycle in addition to standard chemotherapy for 6 cycles. In participants experiencing complete or partial response, MabThera will be continued as consolidation therapy for 2 more cycles.

Detailed description:

Arms: arm 1: Rituximab, 375 milligram per meter square (mg/m\^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).
Interventions: intervention 1: Cyclophosphamide intervention 2: Fludarabine intervention 3: Mitoxantrone intervention 4: Rituximab
Intervention descriptions: intervention 1: as prescribed, 6 cycles intervention 2: as prescribed, 6 cycles intervention 3: as prescribed, 6 cycles intervention 4: 375 mg/m\^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles

Protocol documents:
Clinical trial NCT01147601
Conditions: Hemangioma Infant
Keywords: topical 0.5% Timolol infantile hemangioma (IH)
Sponsor: Oregon Health and Science University
Start date: 2010-03-01; Completion date: 2014-08-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn about a new potential use for topical timolol 0.5% aqueous solution that may help treat small uncomplicated infantile hemangiomas. This study would examine whether topical timolol could be a potential therapy.

Detailed description:
At the first visit, subjects will fill out a questionnaire that asks about the child's history and the hemangioma. Photographs and measurements will be taken at this and each subsequent visit. At the first visit, subjects will have a physical exam, including vital signs, height and weight. An EKG will also be done. Study drug will be dispensed and instructions given. Half of the subjects will receive a placebo. This is a blinded randomized study. Follow-up visits will be weekly for the first two weeks (three visits total including the first visit), then monthly until the study is over. Photographs and measurements will again be taken at each visit. Subjects will be asked to evaluate the size and the color of the hemangioma against the first photographs and fill out forms regarding any changes in behavior and asked about any side effects.

Arms: arm 1: Half of the enrolled subjects (intervention group) will receive topical 0.5% Timolol. arm 2: Aqueous placebo, 2-3 drops to cover the hemangioma, twice daily
Interventions: intervention 1: topical 0.5% Timolol intervention 2: Control (placebo) group
Intervention descriptions: intervention 1: topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily intervention 2: Control (placebo) group

Protocol documents:
Clinical trial NCT01150357
Conditions: Hypertension
Keywords: Pediatric hypertension primary hypertension secondary hypertension
Sponsor: Novartis Pharmaceuticals
Start date: 2010-06-01; Completion date: 2014-08-01
Enrollment: 267 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and high weight-based doses. The low dose ranges from 6.25 mg to 25 mg of aliskiren, the mid dose ranges from 37.5 mg to 150 mg of aliskiren and the high dose ranges from 150 mg to 600 mg of aliskiren. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in children 6-17 years of age.

Detailed description:

Arms: arm 1: Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren. arm 2: Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren. arm 3: Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
Interventions: intervention 1: Aliskiren (6.25/12.5/25 mg) intervention 2: Aliskiren (37.5/75/150 mg) intervention 3: Aliskiren (150/300/600 mg)
Intervention descriptions: intervention 1: Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the low dose arm, participants used one or more of the 6.25 mg capsule (containing 2 minitablets) once daily to reach the body-weight stratified dose of aliskiren. intervention 2: Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the medium dose arm, participants used one or more of the 37.5 mg capsule (containing 12 minitablets) once daily to reach the body- weight stratified dose of aliskiren. intervention 3: Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the high dose arm, participants used one or more of the 150 mg capsule (containing 48 minitablets) once daily to reach the body- weight stratified dose of aliskiren.

Protocol documents: