ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00508469
Conditions: Open-angle Glaucoma Ocular Hypertension
Keywords: Intraocular pressure Open-angle glaucoma Ocular hypertension Adherence Compliance
Sponsor: Alcon Research
Start date: 2007-10-01; Completion date: 2010-01-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare adherence in patients on a fixed combination of travoprost 0.004%/timolol 0.5% and patients on a concomitant combination of travoprost 0.004% and timolol 0.5% using the Travalert® device.

Detailed description:

Arms: arm 1: One drop in the study eye once daily at 9 p.m. for six months using the Travalert device. arm 2: One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
Interventions: intervention 1: Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav) intervention 2: Travoprost 0.004% eye drops intervention 3: Timolol 0.05% eye drops intervention 4: Travalert Dosing Aid
Intervention descriptions: intervention 1: One drop in the study eye once daily at 9 p.m. for six months using the Travalert device. intervention 2: One drop in the study eye once daily at 9 p.m. for six months using the Travalert device. intervention 3: One drop in the study eye twice daily at 9 a.m. and 9 p.m. for six months using the Travalert device. intervention 4: Approved device used with study medication to record time of instillation and quantify dosing

Protocol documents:
Clinical trial NCT00516503
Conditions: Chronic Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Neurotoxicity Pain Unspecified Adult Solid Tumor, Protocol Specific
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2008-02-01; Completion date: 2010-01-01
Enrollment: 208 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Baclofen-amitriptyline-ketamine (BAK) gel may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether BAK gel is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy .

PURPOSE: This randomized phase III trial is studying BAK gel to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.

Detailed description:
OBJECTIVES Primary

* Compare the effectiveness of baclofen-amitriptyline hydrochloride-ketamine (BAK) gel versus placebo, in terms of improving sensory neuropathy, in cancer patients with chemotherapy-induced peripheral neuropathy\> Secondary\>
* Compare motor and autonomic symptoms and functioning, mood states, pain, and peripheral neuropathy in these patients.
* Assess the adverse event profile of topical BAK gel.
* Explore whether topical BAK gel is absorbed systemically. OUTLINE: Patients are stratified according to neurotoxic chemotherapy (active vs non-active), current use of opioids or oral pain medications (yes vs no), pain rating (4-7 vs 8-10), and prior ineffective pharmacologic treatment for peripheral neuropathy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks.
* Arm II: Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks.

Some patients in both arms may choose to continue on the active gel or, if on placebo, begin the active gel for an additional 8 weeks off study. Patients complete health, pain, mood, and quality of life questionnaires at baseline and periodically during study. Patients also record adverse symptoms weekly in a Symptom Experience Diary.

Arms: arm 1: Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel\> topically to each\> area of pain,\> numbness,\> and/or tingling\> on the\> feet and/or hands twice daily\> for\> 4 weeks. arm 2: Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks.
Interventions: intervention 1: baclofen/amitriptyline/ketamine gel intervention 2: placebo
Intervention descriptions: intervention 1: Applied topically intervention 2: Applied topically

Protocol documents:
Clinical trial NCT00527475
Conditions: Macular Degeneration
Keywords: Anti-VEGF therapy photodynamic therapy neovascularization
Sponsor: Texas Retina Associates
Start date: 2007-05-01; Completion date: 2010-01-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Single agent anti-VEGF therapies such as ranibizumab have shown great promise and have set the standard for visual outcomes in treating wet macular degeneration. However, they need to be administered frequently by intraocular injections with the attendant risk of endophthalmitis, lens damage, retinal detachment, and vitreous hemorrhage. The purpose of this trial is to see if using photodynamic therapy in combination with ranibizumab will decrease the number of treatments with ranibizumab.

Detailed description:
A randomized, prospective, multicenter trial will compare two groups of patients with subfoveal choroidal neovascularization secondary to AMD. One group will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year. The other group will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year. Re-treatment will be determined by the individual investigator based on visual acuity, retinal thickness as measured by optical coherence tomography (OCT), and fluorescein angiography. Visual acuity and OCT measurements will be performed by masked examiners.

Arms: arm 1: Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year. arm 2: Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
Interventions: intervention 1: ranibizumab intervention 2: verteporfin
Intervention descriptions: intervention 1: 0.5 mg. given as an intraocular injection intervention 2: Standard dosage of 6 mgs. / meter2 of body surface area given intravenously.

Protocol documents:
Clinical trial NCT00531960
Conditions: Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2008-01-01; Completion date: 2010-01-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the efficacy and safety of Tarceva plus Avastin, and chemotherapy plus Avastin, in the first-line treatment of patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg p.o. daily plus Avastin 15mg/kg i.v. every 3 weeks, or standard platinum-based chemotherapy (4-6 cycles) plus Avastin. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Participants received bevacizumab, 15 milligrams (mg) per (/) kilogram (kg), intravenously (IV), on Day 1 of Cycles 1 through 7 until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received 4 to 6 cycles of a standard platinum-containing regimen of chemotherapy: either gemcitabine, 1250 mg/ square meter (m\^2), IV, on Days 1 and 8 of Cycles 1 through 4 or 6, and cisplatin 80 mg/m\^2, IV, on Day 1 of Cycles 1 through 4 or 6; or paclitaxel, 200 mg/m\^2, IV, and carboplatin area under the curve (AUC) 6 mg/ milliliter (ml) multiplied by (\*) minute (min) on Day 1 of Cycles 1 through 4 or 6. The chemotherapy regimen and number of cycles was up to the discretion of the investigator. arm 2: Participants received bevacizumab, 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib, 150 mg, orally (PO), daily until disease progression, unacceptable toxicity, death, or withdrawal.
Interventions: intervention 1: Erlotinib intervention 2: Bevacizumab intervention 3: Standard platinum-based chemotherapy
Intervention descriptions: intervention 1: 150 mg, PO, daily intervention 2: 15 mg/kg, IV, Day 1 of Cycles 1 through 7 intervention 3: At the discretion of the investigator

Protocol documents:
Clinical trial NCT00548249
Conditions: End-Stage Renal Disease (ESRD)
Keywords: Subjects with ESRD receiving chronic Hemodialysis
Sponsor: Rockwell Medical Technologies, Inc.
Start date: 2007-08-01; Completion date: 2010-01-01
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Dialysate containing soluble iron (Soluble Ferric Pyrophosphate) is safe and effective in maintaining physiological iron levels during chronic hemodialysis.

Detailed description:
The study was designed to evaluate the efficacy of SFP-containing dialysate solution in maintaining physiological iron levels during chronic hemodialysis, as measured by the primary endpoint of the percent of patients whose Hemoglobin (Hgb) decreased by at least 1.0 gram/ deciliter (g/dL) from baseline. The efficacy and safety findings are to be used to determine the optimal concentration of SFP needed to safely maintain iron levels, compensating for iron losses during chronic hemodialysis.

Arms: arm 1: Placebo 0 micrograms (µg) of iron/ deciliter (dL) of dialysate arm 2: 5 micrograms (µg) of iron/ deciliter (dL) of dialysate arm 3: 10 micrograms (µg) of iron/ deciliter (dL) of dialysate arm 4: 12 micrograms (µg) of iron/ deciliter (dL) of dialysate arm 5: 15 micrograms (µg) of iron/ deciliter (dL) of dialysate
Interventions: intervention 1: Standard Bicarbonate Solution intervention 2: Soluble Ferric Pyrophosphate intervention 3: Soluble Ferric Pyrophosphate intervention 4: Soluble Ferric Pyrophosphate intervention 5: Soluble Ferric Pyrophosphate
Intervention descriptions: intervention 1: Patients received 0 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks. intervention 2: Patients received 5 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks. intervention 3: Patients received 10 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks. intervention 4: Patients received 12 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks. intervention 5: Patients received 15 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.

Protocol documents:
Clinical trial NCT00552032
Conditions: Adenoids Hypertrophy
Sponsor: Organon and Co
Start date: 2007-08-01; Completion date: 2010-01-01
Enrollment: 132 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether 8 weeks treatment with mometasone furoate nasal spray (MFNS), twice daily, is safe and effective in treating adenoid hypertrophy in children.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Mometasone Furoate nasal spray intervention 2: Placebo
Intervention descriptions: intervention 1: Mometasone Furoate nasal spray 1 puff (50 mcg) per nostril twice daily x 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months). intervention 2: Placebo nasal spray 1 puff per nostril twice daily x 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).

Protocol documents:
Clinical trial NCT00553280
Conditions: Diabetic Neuropathy, Painful
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2008-02-01; Completion date: 2010-01-01
Enrollment: 123 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and efficacy of the long-term use of pregabalin at doses up to 600 mg/day in patients with painful diabetic peripheral neuropathy who have completed 13 weeks of dosing in Study A0081163

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: pregabalin
Intervention descriptions: intervention 1: Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks

Protocol documents:
Clinical trial NCT00567307
Conditions: Cardiovascular Disease
Sponsor: Wake Forest University Health Sciences
Start date: 2009-01-01; Completion date: 2010-01-01
Enrollment: 216 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this pilot study is to provide data on the feasibility of conducting a large clinical trial on the polypill (combination of aspirin, angiotensin converting enzyme inhibitor, thiazide diuretic, and statin) for primary prevention of cardiovascular disease (CVD). We hypothesized that A "polypill" comprising the aforementioned four components would significantly reduce the estimated 10-year total CVD risk score with high adherence and no significant increase in adverse effects compared to the standard practice.

Detailed description:
This is an open-label, parallel-group, randomized clinical trial comparing a Polypill to Standard Practice (defined as usual care administered to patients with similar conditions). Approximately 200 participants will be recruited from three sites in Sri Lanka: The National Hospital of Sri Lanka, Colombo; Teaching Hospital, Kegalle, and Teaching Hospital, Kandy. Subsequent to granting written informed consent, patients will undergo screening and baseline evaluation to confirm eligibility, followed by randomization to the Polypill or to the Standard Practice study arm. Patients receiving either intervention will return for a total of three monthly clinic visits.

Physician acceptability will be evaluated through a five-question survey will be mailed to a random sample of physicians from the participating clinical sites and to the Council of General Practitioners in Sri Lanka.

Patient acceptability will be measured in participants who will complete the study as well as those who will be screened but not eligible

Arms: arm 1: The Polypill is composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide arm 2: Standard Practice
Interventions: intervention 1: Red Heart Pill 2b (Polypill) intervention 2: Standard Practice
Intervention descriptions: intervention 1: Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg) intervention 2: Arm B will receive management of their CVD risk according to the usual care given to participants in similar conditions

Protocol documents:
Clinical trial NCT00568022
Conditions: Breast Cancer
Sponsor: R-Pharm
Start date: 2008-02-01; Completion date: 2010-01-01
Enrollment: 9 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase II dose of ixabepilone in combination with capecitabine in Japanese participants with metastatic breast cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Ixabepilone intervention 2: Capecitabine
Intervention descriptions: intervention 1: Ixabepilone: Intravenous (IV) Solution, IV, 32(40)mg/m\^2, once every 3 weeks, up to 6 cycles intervention 2: Capecitabine: Tablets, Oral, 1650(2000)mg/m\^2, twice daily for 2 weeks, one week off, up to 6 cycles

Protocol documents:
Clinical trial NCT00568555
Conditions: Fibromyalgia Persian Gulf Syndrome
Sponsor: Stanford University
Start date: 2007-06-01; Completion date: 2010-01-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Low Dose Naltrexone (LDN) has been reported anecdotally to reduce the symptoms of Fibromyalgia, a Chronic Multisystem Illness. The drug may work by regulating natural pain-reducing systems. In this study, we will administer both LDN and placebo to a small group of individuals with Fibromyalgia and Gulf War Syndrome, both Chronic Multisymptom Illnesses, to assess the drug's efficacy in treating the condition.

Detailed description:
This study will be a placebo-controlled, double-blind, cross-over drug tria. Patients with Primary Fibromyalgia or Gulf War Syndrome will be recruited from the Stanford University Pain Management Center and the surrounding community. Participation in the study will cover 22 weeks. Participants will attend a laboratory session 12 times for progress checkups, and will complete daily measures of symptoms.

Arms: arm 1: LDN first, then placebo. arm 2: Placebo first, then LDN.
Interventions: intervention 1: Low Dose Naltrexone intervention 2: Placebo - sugar pill
Intervention descriptions: intervention 1: 3-4.5mg Naltrexone once daily intervention 2: Placebo pill once daily

Protocol documents:
Clinical trial NCT00569231
Conditions: Warts HPV
Keywords: Warts Candida HPV Injections, Intralesional Immune System
Sponsor: University of Arkansas
Start date: 2007-02-01; Completion date: 2010-01-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to look at how people respond to the treatment of warts through use of the Candida antigen to get an immune response to rid the body of human papillomavirus (HPV). The immune system is the part of the body that fights infections like HPV which causes warts. This research study will examine the response of your wart when injected with a portion of a common yeast (candida) which is the study drug. Your immune system response will also be looked at by doing a test called an ELISPOT assay. This test is done on blood samples. The results of this test may help us to determine how the Candida antigen affects your wart.

Detailed description:
The use of recall antigens for treating warts is not yet Food and Drug Administration (FDA) approved. The primary goal of this work was to assess the safety of Candin as an investigational new drug (IND) for the treatment of warts. In addition, clinical resolution of treated and untreated warts was evaluated and immunologic responses were examined using an ex vivo interferon-γ enzyme-linked immunospot (IFN-γ ELISPOT) assay in order to elucidate the immunologic mechanisms behind the successful regression of warts in patients undergoing Candin injection immunotherapy.

Arms: arm 1: None
Interventions: intervention 1: Candida Antigen
Intervention descriptions: intervention 1: Intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.

Protocol documents:
Clinical trial NCT00571259
Conditions: Bacteremia
Keywords: Sodium citrate Gentamicin Prophylaxis Hemodialysis Central venous catheter
Sponsor: Satellite Healthcare
Start date: 2003-09-01; Completion date: 2010-01-01
Enrollment: 303 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a randomized, double blinded, prospective, multicenter, clinical trial of the use of Heparin versus Gentamicin as a pos-dialysis catheter lock solution.

Detailed description:
The study is a randomized, double blinded, prospective, multicenter, clinical trial. All patients requiring vascular access with a tunneled central venous catheter for hemodialysis are eligible for enrollment. Patients will be randomized to receive either Heparin 1,000 U/ml in a volume sufficient to fill the catheter length in both ports or to receive 4% Sodium Citrate with Gentamicin 320 mcg/mL in a volume sufficient to fill the catheter length in both ports.We hypothesize that the device related infection rate in the Citrate/Gentamicin group will be less than the heparin arm.

Arms: arm 1: Catheter lock with heparin 1,000 units/mL arm 2: Catheter lock with gentamicin 320 micrograms/mL in sodium citrate 4%
Interventions: intervention 1: Heparin 1000U/mL intervention 2: 4% Sodium Citrate with Gentamicin 320 mcg/mL
Intervention descriptions: intervention 1: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis intervention 2: A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis

Protocol documents:
Clinical trial NCT00579501
Conditions: Liposarcoma,Myxoid
Keywords: Myxoid Liposarcoma Trabectedin Dexamethasone
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Start date: 2007-04-01; Completion date: 2010-01-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of trabectedin for the treatment of localized (non-metastatic) myxoid / round cell liposarcoma (malignant tumor derived from primitive or embryonal lipoblastic cells).

Detailed description:
This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), multicenter (when more than one hospital or medical school team work on a medical research study) study of trabectedin for the treatment of localized myxoid / round cell liposarcoma (MRCL). Trabectedin will be given at 1.5 milligram per meter square (mg/m\^2) over a 24-hour intravenous (iv) infusion every 3 weeks for a minimum of 3 and a maximum of 6 cycles along with dexamethasone 20 mg iv which will be given within 30 minutes before start of each trabectedin iv infusion. Participants whose myxoid/round cell liposarcoma (MRCL) do not progress at the end of the neoadjuvant treatment will be followed every 6 weeks for disease progression or until 6 months post definitive surgery, in the absence of unacceptable toxicity and/or disease progression. Efficacy will be assessed by determining the pathologic Complete Response (pCR) rate assessed in the tumor surgical specimen by a central pathology review. Participants' safety will be monitored throughout the trial.

Arms: arm 1: Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) will be given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv will also be administered within 30 minutes before start of each trabectedin infusion.
Interventions: intervention 1: Trabectedin intervention 2: Dexamethasone
Intervention descriptions: intervention 1: Trabectedin 1.5 mg/m\^2 over a 24-hour iv infusion every 3 weeks for a minimum of 3 and a maximum of 6 cycles of trabectedin. intervention 2: Dexamethasone 20 mg iv will be administered within 30 minutes before start of each trabectedin iv infusion

Protocol documents: