ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00113334
Conditions: Head and Neck Cancer
Keywords: Head and Neck Cancer Thrombospondin Analogue ABT-510 Antiangiogenic agent Lung Skin Thyroid
Sponsor: M.D. Anderson Cancer Center
Start date: 2005-04-01; Completion date: 2008-03-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goals of this clinical research study are to see how individuals with advanced head and neck cancer respond to treatment with the new drug thrombospondin (ABT-510) and to learn how effective it is in destroying cancer cells. The safety of ABT-510 and the effect ABT-510 has on cells in the body will also be studied.

Detailed description:
This is a phase Ib/II, single-center, open-label study designed to assess the safety, tolerability, pharmacokinetics, and biologic efficacy of ABT-510 (thrombospondin). Participants will be patients with incurable head and neck cancer.

Patients will begin at a fixed dose level of thrombospondin subcutaneously twice daily. Cycles of treatment are 28 days (4 weeks). Patients will be treated with thrombospondin until progression of tumor or toxicity.

Arms: arm 1: Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
Interventions: intervention 1: ABT-510
Intervention descriptions: intervention 1: 100 mg subcutaneously twice daily

Protocol documents:
Clinical trial NCT00142584
Conditions: Hypertension
Keywords: safety and tolerability study hypertension beta-blockers
Sponsor: Mylan Bertek Pharmaceuticals
Start date: 2005-08-01; Completion date: 2008-03-01
Enrollment: 336 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate long-term safety,tolerability and blood pressure effects of metoprolol versus nebivolol in patients with hypertension. These drugs may be given alone or in combination with other drugs that are commonly used in the treatment of hypertension

Detailed description:
Approximately 50 million Americans have hypertension defined as a systolic blood pressure (SBP) greater then or equal to 140 mmHg and/or a diastolic blood pressure (DBP) greater then or equal to 90 mmHg. To control blood pressure, more than 2 agents are required in many patients. The current study is a randomized, titration-to-effect, open-label, multi center study. Patients will be randomized to either nebivolol or metoprolol. The dose of the randomized treatment can be titrated as needed to achieve blood pressure control. If necessary, additional antihypertensive agents (calcium antagonist, diuretic, etc.) can be added to achieve control. Patients will be seen every 1-3 months for approximately 18 months to assess long-term safety, tolerability and effectiveness of nebivolol versus metoprolol.

Arms: arm 1: Nebivolol arm 2: Metoprolol
Interventions: intervention 1: Nebivolol (NEB) intervention 2: Metoprolol (MET)
Intervention descriptions: intervention 1: Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks. intervention 2: Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks.

Protocol documents:
Clinical trial NCT00151411
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome (PCOS) Anovulation Elevated Testosterone
Sponsor: Milton S. Hershey Medical Center
Start date: 2004-10-01; Completion date: 2008-03-01
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the combination therapy of lifestyle intervention and use of Metformin together will improve ovulation induction and hyperandrogenemia in women with polycystic ovary syndrome, by gathering data from adult and adolescent females.

Detailed description:
PCOS is characterized by excess circulating androgen levels and chronic anovulation. PCOS is also characterized by insulin resistance and hyperinsulinemia. Several recent studies in a variety of non-hospital based populations have provided evidence that the incidence of hyperandrogenic chronic anovulation is in the range of 4-6% of the female population. Improvements in insulin sensitivity in women with PCOS, either through lifestyle changes or through pharmaceutical intervention, have consistently resulted in a marked improvement in the reproductive and metabolic abnormalities in PCOS. The primary objective in the adult female population is to determine that combination therapy will improve ovulatory frequency. Secondary objective is to improve circulating hyperandrogenemia and insulin sensitivity then single agent therapy. The primary objective of the adolescent population is to determine that the combination therapy will improve hyperandrogenemia. Secondary objective is to improve ovulatory frequency and insulin sensitivity than just the use of a single agent therapy.

Arms: arm 1: Metformin arm 2: Placebo
Interventions: intervention 1: Metformin intervention 2: Placebo intervention 3: Lifestyle Intervention
Intervention descriptions: intervention 1: Medication was initiated in a step-up fashion every five days, from one tablet per day to four (500 mg per tablet). intervention 2: Placebo intervention 3: A combined intervention of diet and exercise was employed with the goal of achieving an average weight loss of at least 7% of initial body weight over six months with a prescription of 150 min/week of exercise combined with a low-calorie diet.

Protocol documents:
Clinical trial NCT00162097
Conditions: HIV Infections Hepatic Impairment
Sponsor: Bristol-Myers Squibb
Start date: 2004-11-01; Completion date: 2008-03-01
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study was to assess the steady-state pharmacokinetics (PK) of efavirenz (EFV) in human immunodeficiency virus type 1 (HIV-1) infected subjects on stable antiretroviral regimens containing EFV, and having selected degrees of hepatic impairment or normal hepatic function.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: efavirenz containing antiretroviral regimen intervention 2: efavirenz containing antiretroviral regimen intervention 3: efavirenz containing antiretroviral regimen intervention 4: efavirenz containing antiretroviral regimen
Intervention descriptions: intervention 1: Capsule or Tablet, Oral, once daily for 2 days intervention 2: Capsule or Tablet, Oral, once daily for 2 days intervention 3: Capsule or Tablet, Oral, once daily for 2 days intervention 4: Capsule or Tablet, Oral, once daily for 2 days

Protocol documents:
Clinical trial NCT00192114
Conditions: Colonic Neoplasms
Sponsor: Eli Lilly and Company
Start date: 2005-08-01; Completion date: 2008-03-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Enzastaurin given daily to participants with colorectal cancer who have Stage 4 disease and have not received prior chemotherapy for advanced colorectal cancer

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Enzastaurin HCl
Intervention descriptions: intervention 1: 1200 milligrams (mg) loading dose orally, then 500 mg, orally, daily, up to six 28-day cycles.

Protocol documents:
Clinical trial NCT00208026
Conditions: Netherton Syndrome
Sponsor: Children's Hospital of Philadelphia
Start date: 2005-09-01; Completion date: 2008-03-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Netherton syndrome is a genetic condition that can result in abnormal skin functioning. People with this condition often have red and scaling skin; sparse or short hair; and problems with absorption of medicines or chemicals that are applied to the skin. If these chemicals are absorbed at a high level, they may cause health problems. Elidel (pimecrolimus) is a new medicine that is available as a cream. It has been shown to help improve the appearance of the skin in patients with another skin condition known as atopic dermatitis, and is approved by the United States (US) Food and Drug Administration for use in children with mild to moderate atopic dermatitis. The purpose of this study is to determine if Elidel is safe, to see whether the medication is absorbed through the skin, and to see if side effects are associated with its use in children with Netherton syndrome.

Detailed description:
Patients with Netherton syndrome, a rare genodermatosis, manifest a chronic, eczematous dermatitis with erythema and scaling that is often recalcitrant to conventional therapy with emollients and topical corticosteroids. These patients display an altered epidermal barrier with increased permeability to topical agents and are therefore susceptible to evaporative transepidermal water loss and infection. Topical therapy with the calcineurin inhibitors tacrolimus and pimecrolimus has been demonstrated to improve the skin integrity and the quality of life of patients with several chronic dermatoses, including atopic dermatitis. As a result of the underlying skin barrier dysfunction, however, the possibility of significant systemic absorption and resultant side effects is a concern when these agents are used in patients with Netherton syndrome. Experience with topical tacrolimus 0.1% ointment for patients with Netherton syndrome has demonstrated both marked efficacy as well as significant systemic absorption of the drug in this patient population. Use of topical pimecrolimus in patients with Netherton syndrome has not been reported to date. Investigation of the extent of systemic absorption and side effects will help to define the safety and efficacy profile of topical pimecrolimus in patients with Netherton syndrome.

Arms: arm 1: Treatment with drug/Elidel. Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:
Interventions: intervention 1: Pimecrolimus 1% Cream
Intervention descriptions: intervention 1: Open label single arm

Protocol documents:
Clinical trial NCT00216125
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
Sponsor: Nasser Hanna, M.D.
Start date: 2002-02-01; Completion date: 2008-03-01
Enrollment: 243 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In a previous phase II study, patients with pathological stage IIIb (without pleural effusion) NSCLC were treated with concurrent cisplatin and etoposide plus thoracic radiotherapy followed by 3 cycles of consolidation therapy with docetaxel. Docetaxel was selected based upon a survival benefit in patients with recurrent NSCLC.

This trial will evaluate the role of consolidation therapy with docetaxel in patients with unresectable stage III disease. The purpose of the trial is to evaluate survival and toxicities of the regimens employed.

Detailed description:
OUTLINE: This is a multi-center study.

* Cisplatin 50 mg/m2 d1, 8, 29, 36
* Etoposide 50 mg/m2/day d1-5, 29-33
* Radiation 5940 cGy (180 cGy/day)

Patients with CR, PR, SD Randomized to either:Docetaxel75 mg/m2 q3wk X 3 cycles

or Observation Only

Performance Status: ECOG 0 or 1

Life Expectancy: Not specified

Hematopoietic:

* ANC \> 1,500/mm3
* Platelet count \> 100,000/mm3
* Hemoglobin \> 8 g/dl. PRBC transfusions will be allowed to increase hemoglobin to \>8 g/dl

Hepatic:

* Serum bilirubin \< institutional upper limit of normal (ULN)
* AST \< 2.5 X the upper limits of normal if alkaline phosphatase is \< ULN, or alkaline phosphatase may be up to 4 X ULN if AST are \< ULN

Renal:

* Serum creatinine of \< 2 mg/dl or calculated creatinine clearance \> 50 cc/min

Cardiovascular:

* No clinically significant history of cardiac disease, (i.e. uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the past year, or cardiac ventricular arrhythmias requiring medication).

Pulmonary:

* Pre-registration FEV1 \> 1 liters by spirometry within 42 days prior to study treatment.

Arms: arm 1: Prior to randomization patients received Cisplatin 50 mg/m\^2 days 1,8,29,36 + Etoposide 50 mg/m\^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm. arm 2: Docetaxel 75 mg/m\^2 q3wk X 3 cycles. arm 3: Patients were followed for Observation.
Interventions: intervention 1: Cisplatin intervention 2: Etoposide intervention 3: Radiation intervention 4: Docetaxel
Intervention descriptions: intervention 1: Cisplatin 50 mg/m2 day 1, 8, 29, 36 intervention 2: Etoposide 50 mg/m2, days 1-5, 29-33 intervention 3: Radiation 5940 cGy (180 cGy/day) intervention 4: docetaxel 75mg/m2 q3wk x 3 cycles

Protocol documents:
Clinical trial NCT00239005
Conditions: Renal Transplant
Keywords: QoL GI Side Effects MPA
Sponsor: Novartis Pharmaceuticals
Start date: 2005-09-01; Completion date: 2008-03-01
Enrollment: 134 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open, multi-center randomized controlled study is designed to investigate the quality of life in patients with mycophenolate mofetil (MMF)-induced gastrointestinal (GI) adverse events after converting to enteric-coated mycophenolate sodium (EC-MPS).

Detailed description:

Arms: arm 1: 250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening. arm 2: Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
Interventions: intervention 1: Enteric-Coated Mycophenolate Sodium (EC-MPS) intervention 2: Mycophenolate Mofetil (MMF)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00243932
Conditions: Amyotrophic Lateral Sclerosis Lou Gehrig's Disease
Keywords: amyotrophic lateral sclerosis ALS Lou Gehrig's disease CoQ10 coenzyme Q10 antioxidants free radicals mitochondrial dysfunction
Sponsor: Columbia University
Start date: 2005-04-01; Completion date: 2008-03-01
Enrollment: 185 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy and preferred dose of CoQ10 in individuals with ALS for a possible future phase III study.

Detailed description:
Amyotrophic lateral sclerosis (ALS) is a progressive and devastating neurodegenerative disorder. Available treatment for ALS remains scarce. Oxidative stress and mitochondrial dysfunction have been implicated in the pathophysiology of ALS. Oxidative stress refers to the effects of cell-damaging reactive oxygen species, also known as free radicals. Oxidative stress is thought to contribute to nerve cell loss in ALS. Mitochondria are organelles within each cell that are sometimes called "powerhouses of the cell" because cellular energy metabolism is located within the mitochondria.

Coenzyme Q10 (CoQ10), a mitochondrial cofactor known for its antioxidant properties, has prolonged survival in the mouse model of ALS and has slowed functional decline in another neurodegenerative disorder, Parkinson's disease. The goals of this double-blind, placebo-controlled, two-dose comparison phase II study are to obtain preliminary efficacy data and to select the preferred dose for a larger phase III study.

Participants were randomly assigned to CoQ10 (at two different dose levels) or placebo in the first stage, then the 2,700 mg dose was selected in the second stage. Duration of the trial was 9 months with a total of 7 visits.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: coenzyme Q10 intervention 2: Placebo
Intervention descriptions: intervention 1: antioxidant and mitochondrial cofactor, given in capsules three times daily intervention 2: Placebo capsules, indistinguishable from CoQ10 capsules, given three times daily

Protocol documents:
Clinical trial NCT00253747
Conditions: ADHD Smoking
Sponsor: University of Cincinnati
Start date: 2005-11-01; Completion date: 2008-03-01
Enrollment: 255 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate whether Osmotic-Release Methylphenidate (OROS MPH), relative to placebo, increases the effectiveness of standard smoking treatment (i.e., nicotine patch and individual smoking cessation counseling) in obtaining prolonged abstinence for smokers with Attention Deficit Hyperactivity Disorder (ADHD).

Detailed description:
The primary objective of this study is to evaluate whether OROS MPH (Concerta), relative to placebo, increases the effectiveness of standard smoking treatment (i.e., nicotine patch and individual smoking cessation counseling) in obtaining prolonged abstinence for smokers with ADHD. The study will involve an estimated 252 participants, recruited from approximately 6 sites.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Osmotic-Release Methylphenidate intervention 2: Placebo
Intervention descriptions: intervention 1: OROS-MPH dosing strategy will start with 18 mg/day for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). And, nicotine patch dosing schedule will be 21 mg/day during weeks 4-11; 14 mg/day during weeks 12-13; and 7 mg/day in week 14. intervention 2: OROS-MPH (placebo) dosing strategy will start with 18 mg/day for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). And, nicotine patch dosing schedule will be 21 mg/day during weeks 4-11; 14 mg/day during weeks 12-13; and 7 mg/day in week 14.

Protocol documents:
Clinical trial NCT00276549
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate stage IV prostate cancer
Sponsor: Case Comprehensive Cancer Center
Start date: 2005-10-01; Completion date: 2008-03-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, 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 drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with metastatic prostate cancer.

Detailed description:
OBJECTIVES:

* Determine the objective response rate and toxicity in patients with androgen-independent metastatic prostate cancer treated with gemcitabine hydrochloride and docetaxel.

OUTLINE: This is an open-label study.

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 followed by docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for at least 5 years.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: docetaxel intervention 2: gemcitabine hydrochloride
Intervention descriptions: intervention 1: docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. intervention 2: IV over 30 minutes on days 1 and 8 followed by docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT00318292
Conditions: Pain, Postoperative
Keywords: preemptive analgesia paracervical block vaginal hysterectomy
Sponsor: Mayo Clinic
Start date: 2006-04-01; Completion date: 2008-03-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Preemptive analgesia is an intervention which provides an anesthetic prior to initiating a painful stimulus. This trial is examining the effects of a local anesthetic given at the point of innervation prior to performing a vaginal hysterectomy with suspension sutures.

Detailed description:

Arms: arm 1: Active preemptive local analgesia. arm 2: Placebo for preemptive local analgesia.
Interventions: intervention 1: bupivacaine and epinephrine intervention 2: Placebo
Intervention descriptions: intervention 1: 20 ml of 0.5% bupivacaine with 1:200,000 epinephrine paracervical injection. intervention 2: 20 ml normal saline injection.

Protocol documents:
Clinical trial NCT00323492
Conditions: HIV Infections
Keywords: HIV 1 Infection
Sponsor: Gilead Sciences
Start date: 2005-09-01; Completion date: 2008-03-01
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study looked at lipid changes in human immunodeficiency virus type 1 (HIV-1) infected patients when the nucleoside reverse transcriptase inhibitors (NRTIs) in their existing highly active antiretroviral therapy (HAART) regimen were switched to Truvada® (a fixed dose combination tablet of emtricitabine/tenofovir disoproxil fumarate 200 mg/300 mg \[FTC/TDF\]). Subjects continued their nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI) at the same dose.

Detailed description:
This was a Phase IV, multicenter (in France), open label study. The study was conducted in two phases: a comparative randomized phase, which served the primary objective of the study, and a follow-up phase.

Study Phase 1, Day -14 to Week 12: patients were randomized on a 1:1 basis to one of two groups:

* A. Truvada (substitution of their current NRTIs by Truvada \[FTC/TDF\] with continuation of their current NNRTI or PI at the same dose)
* B. Maintain Baseline Regimen (continuation of previous HAART regimen, i.e., maintained baseline regimen).

This phase of the study served the primary objective of the study.

Study Phase 2, roll-over follow-up, Week 12 to Week 48: Patients in the Truvada group continued with Truvada + an NNRTI or PI. Patients in the control group could switch their NRTIs to Truvada in this phase of the study (Delayed Truvada group).

Patients were assessed for efficacy and safety during both phases of the study.

Arms: arm 1: Truvada once daily with continuation of the current NNRTI or PI at randomization arm 2: Maintain baseline regimen arm 3: Truvada once daily with NNRTI or PI (participants from the comparator group who switched to Truvada during Study Phase 2) arm 4: Truvada once daily with NNRTI or PI (all participants who received Truvada during the study, i.e., participants in the Truvada and Delayed Truvada groups)
Interventions: intervention 1: Truvada intervention 2: Current HAART regimen
Intervention descriptions: intervention 1: Truvada + NNRTI or PI. intervention 2: Maintain baseline regimen

Protocol documents:
Clinical trial NCT00332488
Conditions: Diabetes Mellitus, Type 2
Sponsor: Mannkind Corporation
Start date: 2004-12-01; Completion date: 2008-03-01
Enrollment: 547 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue

Detailed description:

Arms: arm 1: Technosphere Insulin arm 2: Metformin \& Secretagogues arm 3: Technosphere \& Metformin
Interventions: intervention 1: Technosphere Insulin intervention 2: Metformin & Secretagogues intervention 3: Technosphere Insulin & Metformin
Intervention descriptions: intervention 1: Inhalation, 15U/30U, prandial intervention 2: Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations. intervention 3: Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets

Protocol documents: