ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00107276
Conditions: Breast Cancer
Keywords: stage IV breast cancer recurrent breast cancer
Sponsor: SWOG Cancer Research Network
Start date: 2005-08-01; Completion date: 2009-08-01
Enrollment: 112 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one chemotherapy drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with capecitabine works in treating women with stage IV breast cancer.

Detailed description:
OBJECTIVES:

* Determine the response rate (complete and partial, confirmed and unconfirmed) in women with stage IV breast cancer treated with oral cyclophosphamide and oral capecitabine.
* Determine the progression-free survival and overall survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
* Determine the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral cyclophosphamide once daily on days 1-14 and oral capecitabine twice daily on days 8-21. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then at weeks 7, 13, 19, and 25.

After completion of study treatment, patients are followed every 3 months for up to 2 years.

PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study within 4 years.

Arms: arm 1: cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
Interventions: intervention 1: capecitabine intervention 2: cyclophosphamide
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00113841
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma Diferuloylmethane Derivative Curcumin Bioperine
Sponsor: M.D. Anderson Cancer Center
Start date: 2004-11-01; Completion date: 2009-08-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objectives:

1. To evaluate clinical tolerance and response to curcumin alone and in combination with Bioperine in patients with multiple myeloma.
2. To compare the pharmacokinetics and pharmacodynamics of curcumin and curcumin + Bioperine and evaluate the effect of Bioperine on the bioavailability of curcumin.
3. To evaluate the biologic effects of curcumin alone and in combination with Bioperine on the expression of NF-kB and related genes in the Multiple Myeloma (MM) cells.

Detailed description:
Curcumin, a yellow substance extracted from the plant Curcuma longa, is commonly used as a food additive. It is a natural anti-inflammatory compound and has shown anti-tumor activity in the laboratory. Bioperine is a pepper extract that increases the absorption of nutrient supplements.

In this study, 6 patients at a time will be randomly assigned (as in the toss of a coin) to one of two groups of 3 patients each. One group (Arm A) will receive curcumin alone. The other group (Arm B) will receive curcumin in combination with Bioperine. There is an equal chance of being in either group. While on study you may receive standard supportive care as appropriate.

Both of the study agents will be taken by mouth two times a day. Each group will have five dose levels of curcumin, starting with the lowest dose. After 6 patients have been enrolled in the first level (3 in each arm), the next group will be treated at a new dose level. You will always receive the same dose during your treatment, which will continue for at least 12 weeks unless there is evidence that the disease has gotten worse or intolerable side effects occur. You may receive treatment up to one year depending on your response to treatment.

You may be treated as outpatient and may receive your treatment at home. You will be asked to return to M. D. Anderson every 4 weeks for evaluation and physical exam.

This is an investigational study. A total of up to 30 evaluable patients will take part in the study. All will be enrolled at M. D. Anderson.

Arms: arm 1: Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.). arm 2: Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily.
Interventions: intervention 1: Curcumin intervention 2: Bioperine
Intervention descriptions: intervention 1: 2 grams (Capsules) orally in 2 divided doses (a.m., p.m.) intervention 2: 5 mg (Tablets) orally twice daily

Protocol documents:
Clinical trial NCT00124943
Conditions: Coronary Restenosis
Keywords: Prevention of Instent Restenosis
Sponsor: Celgene Corporation
Start date: 2005-07-01; Completion date: 2009-08-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to investigate the use of systemic intracoronary administration of albumin-bound paclitaxel, ABI-007, for the prevention and reduction of restenosis following de novo stenting or following angioplasty for in-stent restenosis.

Detailed description:
This study consisted of a Phase I non-randomized dose escalation phase to determine the maximum tolerated dose and a randomized Phase II component to assess preliminary efficacy. Nanoparticle paclitaxel was administered by intracoronary catheter following either successful and uncomplicated stenting of de novo lesions in native coronary arteries or following successful and uncomplicated balloon angioplasty of instent restenosis (ISR) lesions.

Arms: arm 1: Participants received a single dose of 10 mg/m\^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions). arm 2: Participants received a single dose of 22 mg/m\^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions). arm 3: Participants received a single dose of 35 mg/m\^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions). arm 4: Participants received a single dose of 45 mg/m\^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
Interventions: intervention 1: Nanoparticle Paclitaxel
Intervention descriptions: intervention 1: Nanoparticle albumin-bound paclitaxel, administered via intracoronary catheter.

Protocol documents:
Clinical trial NCT00131677
Conditions: HIV Infection
Sponsor: Centers for Disease Control and Prevention
Start date: 2005-02-01; Completion date: 2009-08-01
Enrollment: 400 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine safety and tolerability of daily tenofovir use in HIV-uninfected men.

Detailed description:
This study will assess the clinical and behavioral safety and tolerability of oral daily TDF use as pre-exposure prophylaxis (PrEP) to prevent HIV infection in uninfected men.

Arms: arm 1: participants in this arm start study product immediately upon enrollment arm 2: participants in this arm start study product immediately upon enrollment arm 3: persons in this arm start study product 9 months after enrollment arm 4: participants in this arm start study product nine months after enrollment
Interventions: intervention 1: tenofovir disoproxil fumarate intervention 2: placebo
Intervention descriptions: intervention 1: study product taken daily intervention 2: study product taken daily

Protocol documents:
Clinical trial NCT00177294
Conditions: Depression
Keywords: Elderly Remission Escitalopram Interpersonal Psychotherapy Psychotherapy Caregiving Late-Life
Sponsor: University of Pittsburgh
Start date: 2004-04-01; Completion date: 2009-08-01
Enrollment: 319 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine whether adding interpersonal psychotherapy to treatment with the antidepressant escitalopram will be more effective in reducing symptoms of depression than antidepressant medication alone.

Detailed description:
The purpose of this research study is to learn if adding psychotherapy (Interpersonal Psychotherapy) to antidepressant medication (escitalopram), will be more effective in reducing lingering symptoms of depression and decreasing the burden of these symptoms, when initial treatment with just antidepressant medication alone has led to only a partial response. Participation in the study will last up to 22 weeks.

Because fewer than 50% of elderly depressed patients achieve remission and recovery in response to first-line antidepressant pharmacotherapy, the majority of patients are left with significant symptoms and functional impairment, putting them at risk of chronic, relapsing illness, non-adherence to other medical treatment, suicide, and family caregiver burden. We will recruit and treat 320 patients with unipolar major depression aged 60 and older, using clinical management with escitalopram 10 mg/day for six weeks. Patients who are partial responders to escitalopram plus clinical management will be randomly assigned to 16 weeks of extension therapy with either 20 mg escitalopram plus clinical management or 20 mg escitalopram plus Interpersonal Psychotherapy (IPT, 16 sessions). Changes over time in measures of depressive symptoms, hopelessness, suicidal ideation, disability, and family caregiving burden will be assessed. This study will answer the question of how best to treat partial responders-by simply extending pharmacotherapy at higher doses, or by also adding psychotherapy-to remission and recovery.

For information on related studies, please follow these links:

http://clinicaltrials.gov/show/NCT00178035

http://clinicaltrials.gov/show/NCT00178074

Arms: arm 1: Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT) arm 2: Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management(DCM) without interpersonal psychotherapy (IPT)
Interventions: intervention 1: Escitalopram intervention 2: Interpersonal Psychotherapy intervention 3: Clinical Monitoring
Intervention descriptions: intervention 1: Escitalopram 10 mg daily for first 6 weeks, followed by escitalopram 20 mg daily for 16 additional weeks. intervention 2: 16 sessions of interpersonal psychotherapy (IPT) intervention 3: 16 weeks of depression care management(DCM). No psychotherapy will be provided.

Protocol documents:
Clinical trial NCT00191386
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Start date: 2005-05-01; Completion date: 2009-08-01
Enrollment: 228 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The study is long-term extension study to evaluate long-term safety and efficacy of Atomoxetine in Japanese pediatric patients with Attention-Deficit/Hyperactivity Disorder (AD/HD).

Detailed description:

Arms: arm 1: 0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
Interventions: intervention 1: Atomoxetine hydrochloride
Intervention descriptions: intervention 1: 0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years

Protocol documents:
Clinical trial NCT00193063
Conditions: Breast Cancer
Sponsor: SCRI Development Innovations, LLC
Start date: 2001-07-01; Completion date: 2009-08-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Due to its remarkable activity as salvage treatment in women with metastatic breast cancer as well as the additive activity observed for gemcitabine administered in combination with trastuzumab, the clinical activity of the combination of gemcitabine administered with trastuzumab represents an exciting and ideal combination to further evaluate in Her 2 over-expressing metastatic breast cancer patients.

Detailed description:
Upon determination of eligibility, all patients will be receive:

Gemcitabine + Trastuzumab

Arms: arm 1: All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
Interventions: intervention 1: Trastuzumab intervention 2: Gemcitabine
Intervention descriptions: intervention 1: Trastuzumab intervention 2: Gemcitabine

Protocol documents:
Clinical trial NCT00193414
Conditions: Lung Cancer
Sponsor: SCRI Development Innovations, LLC
Start date: 2005-05-01; Completion date: 2009-08-01
Enrollment: 72 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to study the role of an active and well-tolerated non-platinum agent, gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced NSCLC. This study will serve to define the role of next generation agents in a new combination regimen in the treatment of advanced NSCLC. This combination regimen may ultimately be important in further expanding treatment options for patients while improving survival, quality of life, and symptom control compared with platinum-based combination regimens - and with acceptable toxicity.

Detailed description:
Upon determination of eligibility, patients will be receive:

* Pemetrexed + Gemcitabine

Arms: arm 1: Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
Interventions: intervention 1: Pemetrexed intervention 2: Gemcitabine
Intervention descriptions: intervention 1: 500mg/m2 IV over 10 min, Day 1, prior to gemcitabine intervention 2: 1500mg/m2, 30min IV

Protocol documents:
Clinical trial NCT00299416
Conditions: Acute Ischemic Stroke
Keywords: Stroke Nonhemorrhagic hypothermia
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2003-02-01; Completion date: 2009-08-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Caffeinol is a combination of caffeine and alcohol. The amount given is about the same as 1-2 glasses of wine and 3-4 cups of coffee. The patient receives a one time dose given over two hour while being cooled to 34.5 C.

Detailed description:

Interventions: intervention 1: Caffeinol intervention 2: hypothermia
Intervention descriptions: intervention 1: Infusion of caffeinol (9mg/kg caffeine + 0.4g/kg ethanol) over 2 hours. intervention 2: External or internal cooling for 24 hours and rewarming over 12 hours.

Protocol documents:
Clinical trial NCT00327470
Conditions: Age Related Macular Degeneration (AMD) Macular Degeneration Choroidal Neovascularization (CNV)
Keywords: neovascular age related macular degeneration choroidal neovascularization
Sponsor: Pfizer
Start date: 2006-07-01; Completion date: 2009-08-01
Enrollment: 288 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the benefits of treating subjects with neovascular age-related macular degeneration (AMD) at an earlier stage of choroidal neovascularization (CNV) as compared to those with established CNV. Additionally, the study would like to determine the efficacy of Macugen in preserving visual function in those subjects having CNV secondary to neovascular AMD.

Detailed description:
A decision was made by the sponsor (08 May 2009) to terminate this study early; the study had achieved the primary objective prior to termination. This study was not terminated due to safety reasons.

Arms: arm 1: None
Interventions: intervention 1: Pegaptanib Sodium 0.3 mg
Intervention descriptions: intervention 1: Pegaptanib Sodium dosed every 6 weeks in affected eye.

Protocol documents:
Clinical trial NCT00332189
Conditions: Phenylketonuria
Keywords: PKU
Sponsor: BioMarin Pharmaceutical
Start date: 2006-07-01; Completion date: 2009-08-01
Enrollment: 111 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate the safety of long-term treatment with Phenoptin in subjects with phenylketonuria (PKU) who participated in Phase 3 clinical studies with Phenoptin.

Detailed description:

Interventions: intervention 1: sapropterin dihydrochloride
Intervention descriptions: intervention 1: 5-20mg/kg/day orally, dose may be adjusted up or down as needed at the discretion of the investigator in increments of 5mg/kg/day.

Protocol documents:
Clinical trial NCT00337675
Conditions: Asthma
Sponsor: Organon and Co
Start date: 2006-10-01; Completion date: 2009-08-01
Enrollment: 1771 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a year-long study evaluating the efficacy of both daily and intermittent treatment of asthma in children who experience symptoms episodically (i.e., seasonally, usually in the context of upper respiratory tract infection).

Detailed description:

Arms: arm 1: Montelukast once a day (qd) + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period arm 2: Placebo qd + episode driven supplemental Montelukast qd for 12 days for a 52-wk treatment period arm 3: Placebo qd + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period
Interventions: intervention 1: montelukast sodium intervention 2: Comparator: Placebo (unspecified) intervention 3: montelukast sodium
Intervention descriptions: intervention 1: Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period. intervention 2: Placebo (Pbo) qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period. intervention 3: Pbo qd + episode driven supplemental Montelukast 4 mg (or 5 mg, depending on age of patient) qd for 12 days for a 52-wk treatment period.

Protocol documents:
Clinical trial NCT00379808
Conditions: Coronary Heart Disease
Keywords: coronary heart disease montelukast inflammation
Sponsor: University of Florida
Start date: 2006-07-01; Completion date: 2009-08-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether a particular substance involved in inflammation, called leukotrienes, is involved in causing heart disease to occur or to progress.

Detailed description:
The focus of this study is to better understand why some adults develop heart disease and others do not. There are many known factors which play a role in causing heart disease, such as diet and lifestyle. Also, we know that inflammation, a process in the body which causes painful joints in arthritis or swelling at a site if injury, also contributes to heart disease. In particular, we will address whether leukotrienes, a component of inflammation, is involved in promoting heart disease. We will study this by giving subjects at high risk for heart disease a drug called montelukast which causes leukotrienes to have a reduced effect in the body. In addition for comparison, we will give other subjects a placebo for the same amount of time. These subjects will then be crossed-over and will receive either montelukast or placebo depending on which treatment they received first. We will compare these subjects using blood tests to see if subjects who take montelukast show signs of less inflammation caused by early heart disease as compared to subjects who do not.

Arms: arm 1: 1 lactose-containing capsule daily for 1 month arm 2: 1 montelukast 10 mg tablet (masked by capsule) daily for 1 month
Interventions: intervention 1: montelukast intervention 2: Placebo
Intervention descriptions: intervention 1: 10 mg tablet (masked by capsule) daily for 1 month intervention 2: 1 lactose-containing capsule daily for 1 month

Protocol documents:
Clinical trial NCT00407797
Conditions: Partial Seizures
Keywords: Lyrica Epilepsies - Partial
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2007-03-01; Completion date: 2009-08-01
Enrollment: 136 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the clinical improvement by partial seizures reduction, safety and tolerability of subjects having partial epilepsy related to the adjunction of pregabalin BID (75 to 300mg day titration, BID) to existing standard AED (Antiepileptic drugs).

Detailed description:
This study was terminated on 17 March 2009 due to delayed enrollment. The decision to terminate the trial was not based on any safety concerns, but rather on timelines and the difficulty in enrolling patients in this open label, single group study.

Arms: arm 1: None
Interventions: intervention 1: Pregabalin
Intervention descriptions: intervention 1: 150 to 600 mg/day during 21 weeks

Protocol documents: