ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00672100
Conditions: Post-operative Pain
Keywords: Peripheral Nerve Infusion, continuous brachial plexus block, post-operative pain diaphragmatic paresis
Sponsor: William Beaumont Hospitals
Start date: 2009-01-01; Completion date: 2010-08-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Objective: To determine a minimally effective initial local anesthetic bolus required to provide satisfactory analgesia using continuous brachial plexus infusion following arthroscopic shoulder surgery using a double-blind, randomized, study comparing 3 initial doses.

Detailed description:
Aims:

1. To compare pain ratings and supplemental analgesic requirements at discharge from PACU, 24 hours, and 48 hours and 12 weeks following 5, 10, and 20 ml boluses.
2. To compare adverse events including clinical dysphonia, Horner's syndrome, dyspnea, unexpected hospitalization, evidence of local anesthetic toxicity, and hand weakness at discharge from PACU following 5, 10, and 20 ml boluses.
3. To compare impairment in diaphragmatic excursion at discharge from PACU following 5, 10, and 20 ml boluses.
4. To compare patients' satisfaction with analgesia at 24 and 48 hours following 5, 10, and 20 ml boluses.
5. To compare patient rating of functional outcome at baseline and at 12 weeks following 5, 10, and 20 ml boluses.
6. To compare the rate of general anesthesia required following 5, 10, and 20 ml boluses.

Arms: arm 1: Initial Bolus 5 ml Ropivacaine arm 2: Initial Bolus 10 ml Ropivacaine arm 3: Initial Bolus 20 ml Ropivacaine
Interventions: intervention 1: Ropivacaine intervention 2: Ropivacaine intervention 3: Ropivacaine
Intervention descriptions: intervention 1: Initial Bolus 5 ml Ropivacaine via interscalene injection intervention 2: Initial Bolus 10 ml Ropivacaine via interscalene injection intervention 3: Initial Bolus 20 ml Ropivacaine via interscalene injection

Protocol documents:
Clinical trial NCT00681187
Conditions: Neuroendocrine Tumour With Carcinoid Symptoms
Sponsor: Ipsen
Start date: 2008-06-01; Completion date: 2010-08-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary aim of this study is to assess which method of lanreotide Autogel administration patients with neuroendocrine tumours prefer - self/partner administrations or healthcare provided administrations. The study will also assess if self/partner administration can be performed without loss of efficacy and with a preserved safety profile. The impact of self/partner administration on resource utilisation and costs will be studied. In addition, we will also assess the healthcare provider's experience of the two administration practices.

Detailed description:

Interventions: intervention 1: lanreotide (Autogel formulation)
Intervention descriptions: intervention 1: 90 mg or 120 mg once every 28th day

Protocol documents:
Clinical trial NCT00682786
Conditions: Rectal Carcinoma
Keywords: rectal rectum cancer carcinoma
Sponsor: Washington University School of Medicine
Start date: 2002-10-01; Completion date: 2010-08-01
Enrollment: 135 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Determine if genotype-directed neoadjuvant chemoradiation, using information from the thymidylate synthase promoter polymorphism, result in a greater degree of tumor downstaging in high risk patients compared to historical controls.

Detailed description:

Arms: arm 1: Radiation 45 Gy in 25 fractions to the pelvis.

5FU CIVI 225 mg/m2/day by CIVI during radiation

Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable. arm 2: Radiation 45 Gy in 25 fractions to the pelvis.

5FU CIVI 225 mg/m2/day by CIVI during radiation

Irinotecan 50 mg/m2 IV weekly for 5 doses.

Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable.
Interventions: intervention 1: 5FU intervention 2: Radiation intervention 3: Surgery of resectable lesions intervention 4: Irinotecan
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00707980
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder Depression Melancholia Mood Disorder Dysthymic Disorder Drug Therapy
Sponsor: Takeda
Start date: 2008-06-01; Completion date: 2010-08-01
Enrollment: 836 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the long-term efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder.

Detailed description:
The drug that was tested in this study is called vortioxetine. Vortioxetine is being tested to treat depression in people who have major depressive disorder (MDD). This study looked at MDD relief in people who took vortioxetine.

The study enrolled 836 patients that had completed one of two other vortioxetine studies. Participants received 5 mg of vortioxetine for the first week of treatment. After completing the first week of treatment, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day based on participant's response as judged by the doctor.

All participants were asked to take one encapsulated tablet at the same time each day throughout the study.

This multi-center trial was conducted worldwide. The overall time to participate in this study was up to 56 weeks. Participants made 13 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.

Arms: arm 1: Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
Interventions: intervention 1: Vortioxetine
Intervention descriptions: intervention 1: Encapsulated vortioxetine immediate-release tablets

Protocol documents:
Clinical trial NCT00708916
Conditions: Discoid Lupus Erythematosus
Keywords: Cutaneous lupus Intervention Discoid lupus Phosphodiesterase 5 inhibitor
Sponsor: NYU Langone Health
Start date: 2008-06-01; Completion date: 2010-08-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the clinical and immunological effects of the phosphodiesterase type 4 inhibitor, CC-10004, on skin inflammation associated with cutaneous lupus erythematosus.

Detailed description:
Discoid cutaneous lupus is the most common cutaneous manifestation of lupus erythematosus, a chronic, immune mediated disease of unknown etiology. The immune processes underlying cutaneous lupus remain largely unexplored, but recent evidence suggests a role for dendritic cells (DCs), type 1 interferons (IFN) and Th1-type immune processes. Treatment of cutaneous lupus remains limited primarily to anti-malarials, with thalidomide an effective secondary agent. However, side effects associated with these treatments are potentially problematic with chronic use. Phosphodiesterases (PDE) are critical enzymes that degrade cAMP. In particular, PDE type 4 (PDE4) activity is found in inflammatory and immune cells, including DCs. The immune modulator CC-10004 is a PDE4 inhibitor with demonstrated low toxicity in phase I and II clinical studies with potential efficacy in cutaneous lupus. CC-10004 is a well-tolerated, selective PDE4 inhibitor with demonstrated inhibitory effects on Th1-type cytokines and other inflammatory mediators and is under development for the treatment of inflammatory and immune mediated conditions. Prior studies include pilot trials in psoriasis and exercise-induced asthma, with results suggesting clinical efficacy in the former study. This open label, pilot study of 16 weeks duration will explore the clinical and immune-modulating effects of CC-10004 in 10 cutaneous discoid lupus patients. Patients meeting study criteria will receive the drug for 12 weeks, followed by a 4-week washout period. Study visit time points will include weeks 0, 1, 2, 4, 6, 8, 10, 12 and 16, during which we will measure outcomes for clinical, immunological and safety parameters. To investigate early immunological changes occurring in response to treatment, we will also perform skin punch biopsies of lesional sites at week 0 and week 4 for immunohistochemical and molecular analysis.

Arms: arm 1: CC-10004 20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment
Interventions: intervention 1: CC-10004
Intervention descriptions: intervention 1: 20 mg twice daily by mouth for 12 weeks, followed by a 4 week washout period and final assessment

Protocol documents:
Clinical trial NCT00738972
Conditions: Hypertension
Sponsor: Fundación Lindavista del Corazón AC
Start date: 2008-01-01; Completion date: 2010-08-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate pleiotropic effects of simvastatin in hypertensive patients.

Detailed description:

Arms: arm 1: Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A) arm 2: Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B) arm 3: Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C) arm 4: Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
Interventions: intervention 1: valsartan intervention 2: pravastatin intervention 3: simvastatin intervention 4: ezetimibe (+) simvastatin
Intervention descriptions: intervention 1: 80 mg valsartan. Duration: 12 months. Tablets intervention 2: 40 mg pravastatin. Duration: 12 months. Tablets intervention 3: 40 mg simvastatin. Duration: 12 months. Tablets intervention 4: ezetimibe (+) simvastatin 10/40 mg. Duration: 12 months. Tablets

Protocol documents:
Clinical trial NCT00740051
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2008-08-01; Completion date: 2010-08-01
Enrollment: 227 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride)

Detailed description:

Arms: arm 1: 52 week treatment arm 2: First 18 weeks of treatment arm 3: Placebo patients switch to glimepiride week19-52
Interventions: intervention 1: Linagliptin intervention 2: Linagliptin Placebo intervention 3: Glimepiride
Intervention descriptions: intervention 1: 5mg once daily intervention 2: 0 mg placebo comparator for part 1 of study (to 18 weeks) intervention 3: 1-4mg for part 2 of study (weeks 19-52)

Protocol documents:
Clinical trial NCT00747643
Conditions: Tobacco Dependence
Keywords: tobacco nicotine smoking reward reinforcement craving cues conditioned stimuli cue reactivity
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2008-09-01; Completion date: 2010-08-01
Enrollment: 163 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to find out how varenicline works to help people quit smoking. Varenicline, also known as Chantix™, is an U.S. Food and Drug Administration (FDA) approved medication that has been shown to help people quit smoking. This study was trying to evaluate whether varenicline would change the response to smoking and the desire for cigarettes when compared to an inactive placebo control. This was not a quit smoking treatment study, and participants were not asked or required to stop smoking while in this study.

Detailed description:
We proposed the following primary hypotheses:

1. Tonic (i.e., non-cue-provoked) craving levels would be lower in participants receiving varenicline versus placebo.
2. Cue-provoked cravings (self-report and physiological responding) would be lower in participants receiving varenicline versus placebo. (Secondary indices of craving include heart rate and skin conductance.)
3. The two primary indices of nicotine reward/reinforcement (mCEQ and choice index) would be lower in participants receiving varenicline versus placebo. (Secondary indices of nicotine reinforcement include smoking topography variables.)

A final sample of 100 non-treatment seeking daily smokers were recruited from the Tampa-St. Petersburg-Clearwater Metropolitan Area via paid advertisements in, and press releases to, local newspapers, as well as targeted outdoor advertising via flyers (e.g., on public transportation).

Following the screening session, participants were randomly assigned to receive either varenicline or placebo medication.

Arms: arm 1: For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15. arm 2: Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
Interventions: intervention 1: varenicline intervention 2: placebo
Intervention descriptions: intervention 1: Participants in this group received varenicline according to the schedule in the Arm Description. intervention 2: Participants in this group received a placebo and did not receive any active medication according to the schedule in the Arm Description.

Protocol documents:
Clinical trial NCT00755755
Conditions: Uterine Myomas
Sponsor: PregLem SA
Start date: 2008-10-01; Completion date: 2010-08-01
Enrollment: 241 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will assess the efficacy and safety of PGL4001 with concomitant iron administration versus placebo with concomitant iron administration, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

Detailed description:

Arms: arm 1: PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+ arm 2: PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+ arm 3: PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
Interventions: intervention 1: PGL4001 (ulipristal) and iron intervention 2: PGL4001 matching placebo and iron intervention 3: PGL4001 (ulipristal) and iron
Intervention descriptions: intervention 1: tablets intervention 2: tablets intervention 3: Tablets

Protocol documents:
Clinical trial NCT00762463
Conditions: Ankylosing Spondylitis
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2009-07-01; Completion date: 2010-08-01
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a local, multicenter, randomized, active comparator, double-blind, parallel group study with extension will be conducted to evaluate the efficacy and safety of celecoxib versus diclofenac SR in the treatment of Chinese patients with Ankylosing Spondylitis (AS).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Celecoxib intervention 2: Diclofenac SR
Intervention descriptions: intervention 1: capsule, 200 mg QD, 6-12 weeks intervention 2: tablet, 75 mg QD,6-12 weeks

Protocol documents:
Clinical trial NCT00764361
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic Ulcer Wound
Sponsor: NanoSHIFT LLC
Start date: 2009-01-01; Completion date: 2010-08-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a double-blind, one center, two-arm study with a two (2) week Run-In, evaluating the efficacy of a once-daily administration of NanoDOX™ Hydrogel topically applied to diabetic ulcers in concert with professionally administered Standard of Care (SOC) procedures as described by Standard Operating Procedure(s) of the Department of Veterans Administration Hospitals. During the run-in period patients with infected wounds will receive oral antibiotic and not be included in the topical portion of the study until the infection is shown by wound fluid analysis to be resolved. Following a two (2) week Run-In of all patients to receive SOC treatment for diabetic ulcers, patients would have either the investigational material or the placebo hydrogel applied as a part of their wound care. Each patient would receive 1.5 gm packets of either the test article or the placebo hydrogel for a once-daily home treatment accompanied by a dressing change.

Detailed description:
Study of NanoDOX vs placebo on diabetic ulcers of the lower leg/foot.

Arms: arm 1: 1.0% doxycycline gel arm 2: placebo gel
Interventions: intervention 1: doxycycline intervention 2: placebo gel
Intervention descriptions: intervention 1: 1.0% doxycycline gel applied topically to the wound once daily for 20 weeks intervention 2: placebo gel applied topically to the wound once daily for 20 weeks

Protocol documents:
Clinical trial NCT00772382
Conditions: Chronic Kidney Disease Dialysis Hyperphosphatemia
Keywords: Chronic Kidney Disease Dialysis Hyperphosphatemia Phosphate binder
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2008-12-01; Completion date: 2010-08-01
Enrollment: 116 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to demonstrate the long-term safety and tolerability of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with hyperphosphatemia.

The secondary objective of this study is to assess the long-term efficacy of flexible doses of MCI-196.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: MCI-196
Intervention descriptions: intervention 1: 3g to 15g/day (3 times a day), Tablet, 52 weeks of flexible dose

Protocol documents:
Clinical trial NCT00773955
Conditions: Extensive Stage Small Cell Lung Cancer Recurrent Small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2008-11-01; Completion date: 2010-08-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well R-(-)-gossypol acetic acid works in treating patients with recurrent extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as R-(-)-gossypol acetic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the objective response rate of R-(-)-gossypol in patients with recurrent chemotherapy-sensitive extensive stage small cell lung cancer.

II. To determine the time to disease progression. III. To determine the overall survival. IV. To assess the toxicities associated with this drug. V. To explore whether intratumoral Bcl-2 family member expression correlates with sensitivity to targeting by R-(-)-gossypol.

VI. To explore whether the administration of R-(-)-gossypol causes specific induction of the intrinsic apoptotic pathway.

OUTLINE: This is a multicenter study.

Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Blood is collected periodically during treatment for pharmacodynamic analysis. Peripheral blood mononuclear cells are analyzed via protein isolation and western blotting for Bcl-2, cytoplasmic release of cytochrome c, and caspase activation. Available tumor tissue blocks are assessed by immunohistochemistry.

After completion of study therapy, patients are followed periodically for up to 5 years.

Arms: arm 1: Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: R-(-)-gossypol acetic acid intervention 2: pharmacological study intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00780416
Conditions: Hepatitis C
Keywords: Chronic Hepatitis C Protease Inhibitor Telaprevir Peginterferon Alfa-2b Ribavirin
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2008-11-01; Completion date: 2010-08-01
Enrollment: 189 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with (Genotype 1) hepatitis C.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MP-424 intervention 2: Ribavirin intervention 3: Peginterferon Alfa-2b intervention 4: Ribavirin intervention 5: Peginterferon Alfa-2b
Intervention descriptions: intervention 1: 750 mg every 8 hours for 12 weeks intervention 2: 600 - 1000 mg/day based on body weight for 24 weeks intervention 3: 1.5 mcg/kg/week for 24 weeks intervention 4: 600 - 1000 mg/day based on body weight for 48 weeks intervention 5: 1.5 mcg/kg/week for 48 weeks

Protocol documents:
Clinical trial NCT00795600
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2009-04-01; Completion date: 2010-08-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe. The aim of this clinical trial is to compare the change in trunk fat mass, assessed by Double Energy X-ray Absorptiometry (DEXA) after 26 weeks of treatment with insulin detemir or insulin NPH (Neutral Protamine Hagedorn) (both combined with insulin aspart at the main meals) in overweight and obese subjects with type 2 diabetes.

Detailed description:

Arms: arm 1: Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks arm 2: Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
Interventions: intervention 1: insulin detemir intervention 2: insulin NPH
Intervention descriptions: intervention 1: Insulin detemir once daily plus insulin aspart at mealtime intervention 2: Insulin NPH once daily plus insulin aspart at mealtime

Protocol documents:
Clinical trial NCT00796718
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2008-10-01; Completion date: 2010-08-01
Enrollment: 62 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy and safety of treatment with Xeloda plus standard pelvic radiotherapy in participants with locally advanced rectal cancer. Eligible participants will receive Xeloda 825mg/m\^2 orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment. The anticipated time on study treatment is \< 3 months, and the target sample size is \< 100 individuals.

Detailed description:

Arms: arm 1: Capecitabine orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment.
Interventions: intervention 1: Standard radiotherapy intervention 2: Capecitabine [Xeloda]
Intervention descriptions: intervention 1: Administered as prescribed according to normal clinical practice. intervention 2: 825 milligrams per meter square (mg/m\^2) orally twice daily for 5 weeks.

Protocol documents: