ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00218257
Conditions: Cocaine Abuse Cocaine-Related Disorders
Keywords: Cocaine
Sponsor: University of Minnesota
Start date: 2002-07-01; Completion date: 2008-06-30
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Past research has demonstrated that cocaine dependent women experience less severe responses to cocaine during the luteal phase of the menstrual cycle, when estrogen and progesterone concentrations are high. The purpose of this study is to determine whether administered progesterone reduces subjective and physiological responses to cocaine in cocaine dependent individuals.

Detailed description:
Changes in ovarian hormones across the menstrual cycle impact responses to cocaine in women. Studies have shown that cocaine's effects are dampened during the luteal phase of the menstrual cycle, when estrogen and progesterone concentrations are high, relative to the other phases of the cycle, when concentrations of these hormones are relatively low. The purpose of this study is to determine whether progesterone reduces subjective and physiological responses to cocaine in cocaine dependent individuals. In addition, this study will help to advance the possibility of hormonal progesterone and pharmacologically-related drugs as potential treatment components for cocaine abuse.

Participants will undergo two 4-day inpatient periods, totaling 8 days of treatment. For women, the inpatient periods will occur during two consecutive menstrual cycles; for men, these will occur during two consecutive months. On Day 1, participants will receive a first dose of either progesterone or placebo. On Day 2, participants will receive a second and third dose of study medication. Participants will also participate in an adaptation session, which will familiarize the participant with the smoking equipment that will be used the following day. On Day 3, participants will receive a fourth dose of medication 2 hours prior to a smoking lab session. Prior to beginning the smoking lab session, participants will be asked to rate their current cocaine craving, anxiety level, appetite, and premenstrual symptoms. Participants will then be given a sample of the cocaine dose for the given day. During the smoking lab session, participants will be asked additional cocaine craving questions at pre-determined intervals and will be given the option to trade in previously earned tokens for either money or a dose of cocaine. Following completion of the smoking lab session, participants will receive their fifth dose of medication.

Arms: arm 1: 200mg progesterone twice daily arm 2: Placebo twice daily
Interventions: intervention 1: Progesterone intervention 2: Placebo
Intervention descriptions: intervention 1: 200mg progesterone twice daily intervention 2: placebo

Protocol documents:
Clinical trial NCT00286949
Conditions: Parkinson's Disease
Keywords: Parkinson's disease executive dysfunction impairment motor skills cognitive
Sponsor: Johns Hopkins University
Start date: 2005-01-06; Completion date: 2008-06-30
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Atomoxetine (Strattera) is a drug that is currently approved for treatment of attention deficit hyperactivity disorder (ADHD) in children and adults. Atomoxetine works to enhance levels of brain chemicals that may be affected in people with executive dysfunction, (difficulties with organization, task completion, and priority setting). Thus, atomoxetine has the potential to improve executive dysfunction in people with Parkinson's disease (PD).

The goal of this study is to provide preliminary data on the effectiveness and tolerability of atomoxetine for the treatment of executive dysfunction in patients with PD.

Detailed description:
Parkinson's disease (PD), while defined by its motor abnormalities and associated dopaminergic loss, is invariably accompanied by cognitive impairment. Early in the disease course, the deficits are characterized by executive dysfunction with difficulties on tasks that involve information processing, attention, sorting, planning, set-shifting, and working memory and are subserved by neural connections with prefrontal brain regions. There has been little effort to identify treatments for these PD-related cognitive impairments, despite their disabling and distressing effects. Accordingly, the goal of this proposal is to conduct a small pilot study to determine the effectiveness and tolerability of atomoxetine, a selective norepinephrine reuptake inhibitor, for the treatment of executive dysfunction in patients with PD.

Atomoxetine (Strattera) is currently approved by the FDA for treatment of attention deficit hyperactivity disorder (ADHD) in children and adults. Atomoxetine enhances dopaminergic and noradrenergic transmission in frontal regions that are also implicated in executive dysfunction and thus has the potential to improve executive dysfunction in PD as well as other neurological conditions. Results of the study will be used to develop a larger placebo-controlled trial of atomoxetine, if appropriate, as well as inform the design of other clinical trials on potential treatments for cognitive dysfunction in PD.

The overall hypothesis is that atomoxetine will be an effective and safe treatment for executive dysfunction in PD.

Arms: arm 1: Open-Label Uncontrolled Active Drug Intervention, No comparator
Interventions: intervention 1: Atomoxetine
Intervention descriptions: intervention 1: Open Label uncontrolled active Drug intervention

Protocol documents:
Clinical trial NCT00095238
Conditions: Congestive Heart Failure
Sponsor: Bristol-Myers Squibb
Start date: 2002-06-01; Completion date: 2008-07-01
Enrollment: 4128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to learn if Irbesartan is superior to placebo in reducing mortality and cardiovascular morbidity in subjects with heart failure with preserved systolic function. The safety of this treatment will also be studied.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Irbesartan intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years intervention 2: Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years

Protocol documents:
Clinical trial NCT00150176
Conditions: Schizophrenia
Sponsor: Organon and Co
Start date: 2005-04-01; Completion date: 2008-07-01
Enrollment: 831 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Schizophrenia is a brain disease. The condition may be associated with acute psychotic episodes and long-term disability despite remission from the acute symptoms. Current management of schizophrenia focuses on the treatment of acute symptoms as well as long-term treatment aimed at preventing relapse after patients have experienced an improvement in acute symptoms. Patients who discontinue treatment have a high likelihood of experiencing relapse within 1-2 years after an acute episode of schizophrenia. Patients who remain on antipsychotic treatment have lower rates of relapse and have milder courses of exacerbation when relapse occurs.The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other. Asenapine may help to correct the imbalance in dopamine and serotonin. The purpose of this clinical trial is to evaluate the efficacy of asenapine in preventing relapse/impending relapse (hereafter referred to as 'relapse') in subjects who have been treated with asenapine for symptoms of schizophrenia for 26 weeks. In addition, to determine the safety and tolerability of asenapine for up to 1-year of treatment.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Asenapine - Open Label intervention 2: Placebo - Double Blind intervention 3: Asenapine - Double Blind
Intervention descriptions: intervention 1: Open Label Phase: All subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1). intervention 2: Double Blind Phase: Following Open Label Phase, matching placebo sublingual twice daily for 26 weeks. intervention 3: Double Blind Phase: Following the Open Label Phase, asenapine 5 or 10 mg sublingual twice daily for 26 weeks.

Protocol documents:
Clinical trial NCT00219284
Conditions: Parkinson's Disease With End of Dose Wearing Off
Keywords: Parkinson's disease, tremor
Sponsor: Novartis Pharmaceuticals
Start date: 2005-01-01; Completion date: 2008-07-01
Enrollment: 359 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess motor function and quality of life (QoL) in Parkinson's disease (PD) subjects with end-of-dose wearing off, comparing immediate and delayed switch to carbidopa/levodopa and entacapone.

Detailed description:
This was a prospective, multi-center, randomized, open-label study with blinded raters to evaluate the effects of immediate versus delayed switch to carbidopa/levodopa/entacapone on motor function and quality of life in patients with Parkinson's disease with end-of-dose wearing off.

Arms: arm 1: Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch. arm 2: Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
Interventions: intervention 1: Carbidopa/levodopa/entacapone
Intervention descriptions: intervention 1: Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone.

Protocol documents:
Clinical trial NCT00234533
Conditions: Turner Syndrome Renal Insufficiency, Chronic Pituitary Diseases Dwarfism
Keywords: growth child development growth hormone inadequate growth hormone secretion growth failure
Sponsor: Ipsen
Start date: 2004-06-01; Completion date: 2008-07-01
Enrollment: 251 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to establish an optimal monitoring regimen in NutropinAq treated children, using newly developed capillary blood spot IGF-1 measurement technology.

Detailed description:

Arms: arm 1: Patients received daily subcutaneous (s.c.) injections of NutropinAq 10 milligrams (mg)/2 milliliters (mL) for 6 months. The therapeutic daily doses administered were as follows:

* GHD patients: 0.025 - 0.035 mg/ kilogram (kg) bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight

Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.

The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
Interventions: intervention 1: Somatropin (rDNA origin)
Intervention descriptions: intervention 1: Daily subcutaneous injections, 0,025 - 0,05 mg/kg/day for 6 months.

Protocol documents:
Clinical trial NCT00235443
Conditions: Diabetic Neuropathy
Keywords: Painful Distal Diabetic Neuropathy
Sponsor: UCB Pharma
Start date: 2004-09-01; Completion date: 2008-07-01
Enrollment: 451 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and tolerability of the different doses of lacosamide will be investigated.

Detailed description:
This phase 2/3 open-label trial is being conducted at approximately 100 sites in the US to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. Approximately 525 subjects will be enrolled. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have completed trials SP665, SP742, or SP768 and, in the investigator's opinion, may benefit from long-term administration of lacosamide. Subjects will be titrated to their optimal dose of lacosamide (up to 600mg/day). The safety and tolerability of the different doses of lacosamide will be investigated throughout the trial. In addition, to determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity and pain interference with sleep and activity. Subjects' quality of life will also be investigated.

Arms: arm 1: Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Interventions: intervention 1: lacosamide
Intervention descriptions: intervention 1: Open-label treatment (two times per day) with film-coated tablets include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, and 600mg/day throughout individual study period.

Protocol documents:
Clinical trial NCT00386607
Conditions: Hypertension
Keywords: Hypertension, aliskiren, valsartan, HCTZ, blood pressure
Sponsor: Novartis
Start date: 2006-10-01; Completion date: 2008-07-01
Enrollment: 601 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/Hydrochlorothiazide(HCTZ).

Detailed description:

Arms: arm 1: Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combination for 52-weeks, optional addition of Hydrochlorothiazide (HCTZ) 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (mean sitting Systolic Blood Pressure ≥ 140 and/or mean sitting Diastolic Blood Pressure ≥ 90 mmHg). The dose of Hydrochlorothiazide (HCTZ) 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled. arm 2: For patients entering into extension, those previously treated with Hydrochlorothiazide (HCTZ) 12.5 or 25 mg in addition to aliskiren 300 mg/valsartan 320 mg were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 25 mg in the extension. Those patients who had not received HCTZ during the core study were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 12.5 mg.

The HCTZ 12.5 mg dose could be increased to HCTZ 25 mg if the mean sitting Systolic Blood Pressure (msSBP) was ≥140 mmHg and/or the mean sitting Diastolic Blood Pressure (msDBP) was ≥90 mmHg for 2 consecutive visits.
Interventions: intervention 1: Aliskiren intervention 2: Valsartan intervention 3: Hydrochlorothiazide (HCTZ)
Intervention descriptions: intervention 1: Aliskiren 300 mg intervention 2: Valsartan 320 mg intervention 3: Hydrochlorothiazide (HCTZ) 12.5-25 mg

Protocol documents:
Clinical trial NCT00447382
Conditions: Diabetes Diabetes Mellitus, Type 1
Sponsor: Novo Nordisk A/S
Start date: 2007-03-01; Completion date: 2008-07-01
Enrollment: 330 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The trial was conducted in Germany, The Republic of Macedonia, Russian Federation, Serbia and South Africa. The aim of this trial was to make a safety comparison of insulin detemir produced by a new production method (NN729) with insulin detemir made by the previous production method (NN304). Subjects were treated with NN729 or NN304 for a period of 52 weeks at the same total daily dose and frequency of administration as their own pre-trial basal insulin . During the trial doses were individualised based on subject's plasma glucose measurements.

Detailed description:

Arms: arm 1: Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks arm 2: Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
Interventions: intervention 1: insulin detemir intervention 2: insulin aspart intervention 3: insulin detemir
Intervention descriptions: intervention 1: NN304 injected s.c. (under the skin). Given as basal insulin. intervention 2: Injected s.c. (under the skin). Given as bolus insulin. intervention 3: NN729 injected s.c. (under the skin). Given as basal insulin

Protocol documents:
Clinical trial NCT00005879
Conditions: Breast Cancer
Keywords: breast cancer
Sponsor: University of Kansas Medical Center
Start date: 2000-08-01; Completion date: 2008-07-01
Enrollment: 199 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of LY353381 may be an effective way to prevent the development of breast cancer in women who have hyperplasia.

PURPOSE: Randomized phase II trial to study the effectiveness of LY353381 in preventing breast cancer in women who have hyperplasia.

Detailed description:
OBJECTIVES:

* Determine if LY353381 hydrochloride improves baseline cytology in women at high risk for breast cancer.
* Determine if this drug modulates other potential surrogate endpoint biomarkers or drug effect biomarkers.
* Determine if cytologic improvement is associated with initial presentation of the various stratification factors.
* Determine whether cytology is correlated with other potential surrogate endpoint biomarkers or drug effect biomarkers and whether change in cytology is correlated with change in the other biomarkers.
* Monitor the effects of this drug in terms of quality of life and women's health.

OUTLINE: This is a randomized, double-blind, multicenter study followed by an open-label study for both arms. Patients are stratified according to cytologic status (hyperplasia with atypia vs hyperplasia without atypia), mutation status (known carrier for BRCA1 or BRCA2 genes vs known not to be a carrier of mutant genes), menopausal status (premenopausal vs postmenopausal), estrogen-receptor status, and participating center. Patients are randomized to one of two treatment arms.

* Arm I: Patients receive oral LY353381 hydrochloride once daily for 6 months.
* Arm II: Patients receive oral placebo once daily for 6 months. Patients in both arms then receive oral LY353381 hydrochloride for an additional 6 months.

Quality of life is assessed at baseline and then at 6 and 12 months.

Patients are followed at 2 weeks and then annually for 5 years.

PROJECTED ACCRUAL: A total of 210-220 patients will be accrued for this study within 2.5-3 years.

Arms: arm 1: Placebo arm 2: LY353381, 20 mg daily
Interventions: intervention 1: arzoxifene intervention 2: Placebo
Intervention descriptions: intervention 1: one tablet daily intervention 2: matched tablet dialy

Protocol documents:
Clinical trial NCT00042224
Conditions: Schizophrenia
Keywords: Electroconvulsive Therapy
Sponsor: Northwell Health
Start date: 2000-12-01; Completion date: 2008-07-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate electroconvulsive therapy (ECT) in patients who have not responded adequately to clozapine.

Detailed description:
ECT augmentation of clozapine will be compared to clozapine monotherapy in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.

Arms: arm 1: Electroconvulsive therapy ECT plus clozapine for 8 weeks arm 2: Clozapine for 8 weeks
Interventions: intervention 1: Electroconvulsive Therapy (ECT) intervention 2: Clozapine
Intervention descriptions: intervention 1: ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine. intervention 2: Patients with psychotic symptoms will receive clozapine

Protocol documents:
Clinical trial NCT00060840
Conditions: Congestive Heart Failure
Keywords: Left Ventricular Assist Device Implantation Progressive Left Ventricular Failure
Sponsor: Mallinckrodt
Start date: 2003-07-01; Completion date: 2008-07-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the utility of nitric oxide for inhalation during left ventricular assist device (LVAD) implantation following cardiopulmonary bypass (CPB). This is to be assessed by the number of patients in each treatment group meeting failure criteria within 24 hours on study drug, as defined by two or more of the following:

* Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m\^2
* Administration of ≥ 20 inotropic equivalents (IE)

  * 10 µg/kg/min dopamine, dobutamine, enoximone or amrinone is equivalent to 10 IE
  * 0.1 µg/kg/min epinephrine or norepinephrine is equivalent to 10 IE
  * 1 µg/kg/min milrinone is equivalent to 15 IE
  * 0.1 U/min vasopressin is equivalent to 10 IE
* Mean arterial pressure (MAP) ≤ 55 mmHg
* Central venous pressure (CVP) ≥ 16 mmHg
* Percent mixed venous oxygen saturation (SvO2) ≤ 55%

Or at least one of the following criteria:

* Failure to wean from cardiopulmonary bypass at least once due to hemodynamic failure. Re-initiation of cardiopulmonary bypass to correct bleeding or other technical issues will not be considere 'failure to wean'
* Death

Detailed description:
40 ppm of either nitric oxide for inhalation or N2 (placebo) will be continuously administered to the patient starting at least 5 minutes prior to initiating the first weaning attempt from CPB and continue until the patient is either extubated, has reached failure criteria, or has been treated with study drug for 48 hours following discontinuation of CPB, whichever come first.

All patients will be monitored peri-operatively with a pulmonary arterial line, central venous line, and systemic arterial line. Baseline data collection by a designated clinical staff member will begin following induction of anesthesia and prior to skin incision. Following a successful wean from cardiopulmonary bypass, post-op data will be collected within 1 hour following end time of surgery. Data will then be collected at 6, 12, 18, 24, and 48 hours from post-op or until extubation, in which case weaning from study drug will begin.

Open label investigational nitric oxide for inhalation may be administered once a patient meets a minimum of two of the failure criteria or fails to wean at least once due to hemodynamic failure from cardiopulmonary bypass.

Arms: arm 1: Inhaled Nitric Oxide (iNO) at 40 parts per million (ppm) arm 2: Nitrogen (N2) administered at 40 ppm.
Interventions: intervention 1: Nitric Oxide intervention 2: Nitrogen
Intervention descriptions: intervention 1: 40 ppm of Nitric Oxide continuously administered for 48 hours intervention 2: Nitrogen (N2) administered at 40 ppm for 48 hours

Protocol documents: