ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00945139
Conditions: Ovarian Cancer
Sponsor: New Mexico Cancer Research Alliance
Start date: 2007-03-01; Completion date: 2011-08-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to test the safety, tolerability, and effectiveness of two chemotherapy drugs, pegylated liposomal doxorubicin (Doxil) and bevacizumab (Avastin). How Doxil is metabolized and excreted from the body will also be studied.

Detailed description:
Avastin:

Avastin is a humanized monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer). Avastin has been approved for the treatment of colorectal cancer and lung cancer. Avastin is investigational for the treatment of ovarian cancer and has not been approved by the United States Food and Drug Administration (FDA) for this use.

Avastin is thought to work by attaching to a protein called vascular endothelial growth factor (VEGF) to block its action. VEGF plays a role in the formation of both normal and abnormal blood vessels. It is present in normal tissues, but is produced in excess by most solid cancers (tumors). In cancer, VEGF helps blood vessels bring nutrients to tumor cells, allowing the tumor cells to grow. In laboratory studies with human cancer cells grown in animals, Avastin has been shown to prevent or slow the growth of different types of cancer cells by blocking the effects of VEGF.

Doxorubicin:

Doxorubicin is a type of antibiotic that is only used in cancer chemotherapy. It slows or stops the growth of cancer. Doxorubicin has been approved by the FDA to treat cancers of the head, neck, cervix, vagina, testes, prostate, uterus and Ewing's tumor.

Arms: arm 1: Patients receive both agents, doxil and Avastin.
Interventions: intervention 1: Doxil intervention 2: Avastin
Intervention descriptions: intervention 1: Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1 intervention 2: First agent (Doxil) will be following by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression

Protocol documents:
Clinical trial NCT00947349
Conditions: Hepatitis C Pharmacokinetics
Sponsor: Boehringer Ingelheim
Start date: 2009-07-01; Completion date: 2011-08-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The current Standard of Care (SOC) for chronic HCV infection, which is pegylated interferon-alfa as combination therapy with ribavirin for 24-48 weeks of treatment, is effective in only part of the patients and is often associated with severe adverse effects leading to discontinuation of treatment and dose modifications.

A number of compounds with direct activity are currently under clinical development, incl. BI 201335. BI 201335 works by preventing the Hepatitis C virus from replicating by binding to the HCV protease (enzyme). The main purpose of this clinical trial with BI 201335 is to see how well BI 201335 works and how safe BI 201335 is to use daily in combination with PegIFN and RBV in HCV infected patients

Detailed description:

Arms: arm 1: patient to receive a capsule containing low dose of BI 201335 NA/Drug for treatment-naive (TN) patients arm 2: patient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-naive (TN )patients arm 3: patient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-experienced (TE) patients arm 4: None
Interventions: intervention 1: ribavirin (RBV) intervention 2: pegylated interferon (PegIFN) alfa-2a intervention 3: pegylated interferon (PegIFN) alfa-2a intervention 4: ribavirin (RBV) intervention 5: BI 201335 NA low placebo intervention 6: pegylated interferon (PegIFN) alfa-2a intervention 7: ribavirin (RBV) intervention 8: BI 201335 NA high intervention 9: BI 201335 NA low intervention 10: BI 201335 NA high placebo intervention 11: BI 201335 NA high intervention 12: Placebo
Intervention descriptions: intervention 1: ribavirin (RBV) intervention 2: pegylated interferon (PegIFN) alfa-2a intervention 3: pegylated interferon (PegIFN) alfa-2a intervention 4: ribavirin (RBV) intervention 5: Placebo intervention 6: pegylated interferon (PegIFN) alfa-2a intervention 7: ribavirin (RBV) intervention 8: BI 201335 NA high intervention 9: BI 201335 NA intervention 10: placebo intervention 11: BI 201335 NA high intervention 12: None

Protocol documents:
Clinical trial NCT00949078
Conditions: Food Allergy Peanut Allergy
Keywords: peanut allergy
Sponsor: Johns Hopkins University
Start date: 2009-07-01; Completion date: 2011-08-01
Enrollment: 51 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if treatment with omalizumab (Xolair, anti-IgE) can eliminate or reduce symptoms of peanut allergy.

Detailed description:
The study will evaluate if omalizumab is an effective treatment for peanut allergy. In addition we will further evaluate the role of allergic cells (mast cells and basophils) and IgE in food allergy.

Arms: arm 1: Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group. arm 2: Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
Interventions: intervention 1: omalizumab
Intervention descriptions: intervention 1: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE

Protocol documents:
Clinical trial NCT00981045
Conditions: Iron Deficiency Anemia Impaired Renal Function
Keywords: IDA
Sponsor: American Regent, Inc.
Start date: 2009-08-01; Completion date: 2011-08-01
Enrollment: 2561 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to examine the efficacy and safety (cardiovascular) of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to IV iron sucrose (Venofer) in subjects who have iron deficiency anemia (IDA) and impaired renal function.

Detailed description:

Arms: arm 1: 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg arm 2: 5 doses of 200 mg for a total cumulative dose of 1000 mg
Interventions: intervention 1: Ferric Carboxymaltose (FCM) intervention 2: Iron Sucrose (Venofer)
Intervention descriptions: intervention 1: 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg intervention 2: 5 doses of 200 mg for a total cumulative dose of 1000 mg

Protocol documents:
Clinical trial NCT00989989
Conditions: Diabetic Macular Edema
Keywords: DME Diabetic macula edema ranibizumab REVEAL
Sponsor: Novartis
Start date: 2009-09-01; Completion date: 2011-08-01
Enrollment: 396 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or as monotherapy in Asian patients with visual impairment due to Diabetic Macular Edema (DME).

Detailed description:

Arms: arm 1: Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser. arm 2: Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser. arm 3: Active laser treatment plus sham intravitreal injections.
Interventions: intervention 1: Ranibizumab intervention 2: Laser photocoagulation intervention 3: Sham ranibizumab intervention 4: Sham laser photocoagulation
Intervention descriptions: intervention 1: Ranibizumab 0.5 mg intravitreal injection at day 1, month 1 and month 2. If stable vision not reached at month 3, one injection per month continued until stable vision was reached. Intravitreal injections re-initiated if needed. intervention 2: Active laser treatment administered at day 1. Subsequent laser treatments administered if needed at intervals no shorter than 3 months from previous laser treatment. intervention 3: Sham intravitreal injections to ranibizumab at day 1, month 1 and month 2. Intravitreal injections re-initiated if needed. intervention 4: Sham laser treatment administered at day 1.

Protocol documents:
Clinical trial NCT00993317
Conditions: Rheumatoid Arthritis
Keywords: CDP870 Korea CIMZIA
Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Start date: 2009-10-01; Completion date: 2011-08-01
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this trial is to compare the efficacy of Certolizumab (CZP) (CDP870) in combination with Methotrexate (MTX) to MTX alone in the treatment of signs and symptoms in patients with active rheumatoid arthritis (RA) who are incomplete responders to MTX.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo of CDP870 intervention 2: CDP870 200mg intervention 3: Methotrexate
Intervention descriptions: intervention 1: Given every 2 weeks until Week22 (SC) intervention 2: 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week 22(SC) intervention 3: Received treatment with Methotrexate(MTX)for at least 24 weeks prior to the Baseline Visit.

The dose and route of administration of MTX had to have been stable for at least 8 weeks prior to the Baseline Visit. The minimum stable dose of MTX allowed is 10mg weekly.

Protocol documents:
Clinical trial NCT00997672
Conditions: Multiple System Atrophy
Keywords: MSA Lithium Lithium carbonate MSA-P MSA-C
Sponsor: Federico II University
Start date: 2009-10-01; Completion date: 2011-08-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine safety and tolerability of the treatment with lithium in Multiple System Atrophy. Moreover, clinical symptoms, neuronal loss, quality of life and depressive symptoms, will be considered to further investigate the effect of lithium therapy.

Detailed description:
Patients will be progressively enrolled in the study and undergo a screening visit to test for inclusion/exclusion criteria. Patients will then be randomized to receive either Lithium carbonate or placebo. Patients will visit study center at 2, 4, 8, 12, 24, 36 and 48 weeks, for endpoint and laboratory assessments.

Arms: arm 1: None arm 2: Placebo comparator
Interventions: intervention 1: Lithium Carbonate intervention 2: Placebo
Intervention descriptions: intervention 1: Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day. intervention 2: None

Protocol documents:
Clinical trial NCT01000961
Conditions: Cystinosis
Keywords: cystinosis cysteamine inheritable disease orphan disease CTNS protein, human metabolic disease nephropathic cystinosis
Sponsor: Amgen
Start date: 2010-06-01; Completion date: 2011-08-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Cystinosis is an inherited disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate) which must be taken every six hours for the rest of the patient's life to prevent complications of cystinosis. RP103 is a formulation of cysteamine bitartrate that is being studied to see if it may be able to be given less frequently, once every 12 hours, and have similar results to four times a day Cystagon®.

Detailed description:
This is a multi-center, open-label, randomized, cross-over study to determine whether steady-state, twice a day treatment with Cysteamine Bitartrate Delayed-release Capsules(RP103) results in comparable depletion of white blood cell (WBC) cystine levels compared to the existing four times a day cysteamine treatment. It will involve up to 20 clinic visits plus intermittent home use of the RP103. Most of these clinic visits occur in clusters of 3-4 consecutive days. Eligible patients will be offered enrollment into a long-term follow up study.

Study with completed results acquired from Horizon in 2024.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Cystagon® (Cysteamine Bitartrate) intervention 2: Cysteamine Bitartrate Delayed-release Capsules (RP103)
Intervention descriptions: intervention 1: Run-in Period (Weeks 1, 2, 3) and Period 1 (Weeks 4, 5, 6) or Period 2 (Weeks 7, 8, 9); Immediate crossover to opposite treatment than taken during Period 1:

Every 6H, supplied in 150 and 50mg capsules/Duration of Treatment: 3 weeks each period used intervention 2: Period 1 (Weeks 4, 5, 6) or Period 2 (Weeks 7, 8, 9); Immediate crossover to opposite treatment than taken during Period 1:

Every 12H, supplied in 75 and 25mg capsules/Duration of Treatment: 3 weeks

Protocol documents:
Clinical trial NCT01005810
Conditions: Cannabis Dependence
Sponsor: Medical University of South Carolina
Start date: 2009-09-01; Completion date: 2011-08-01
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is investigating how N-Acetylcysteine (NAC), an over-the-counter medication, will reduce marijuana use when combined with Contingency Management, a behavioral treatment. It is hypothesized that marijuana dependent adolescents who are treated with NAC will use less marijuana during treatment when compared to adolescents who receive a placebo.

Detailed description:
This protocol involves investigation of N-Acetylcysteine (NAC) as a pharmacological treatment for cannabis dependence in adolescents. While recent advances have been made in psychosocial treatments for cannabis dependent adolescents, minimal work has been done to investigate the potential adjunctive role for pharmacotherapy in treatment. NAC is an inexpensive, over-the-counter agent with a favorable tolerability profile in adults and children, in common use since FDA approval in 1963. Preclinical and preliminary clinical research in adults suggests a role for NAC in addiction treatment via glutamate modulation.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: N-Acetylcysteine intervention 2: placebo intervention 3: Contingency Management
Intervention descriptions: intervention 1: 1200 mg twice daily for 8 weeks intervention 2: 2 capsules twice daily for 8 weeks intervention 3: rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule

Protocol documents:
Clinical trial NCT01021813
Conditions: Insomnia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-12-10; Completion date: 2011-08-01
Enrollment: 781 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will establish the safety and tolerability of suvorexant (MK-4305) when administered for up to 14 months. Participants will be randomized to receive suvorexant or placebo for a 12-month double-blind (DB) Treatment Phase. Participants who complete the 12-month DB Treatment Phase will enter a 2-month DB Randomized Discontinuation Phase. At the time of initial randomization, participants assigned to receive suvorexant during the initial 12-month Treatment Phase will be simultaneously randomized, in a 1:1 ratio, to receive either suvorexant or placebo during the 2-month Randomized Discontinuation Phase. Participants randomized to receive placebo in the initial 12-month Treatment Phase will continue to receive placebo during the 2-month Randomized Discontinuation Phase.

The first 3 nights of the Randomized Discontinuation Phase are referred to as the Run-Out Phase, and will assess rebound and withdrawal.

Detailed description:

Arms: arm 1: After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to \<65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the Treatment Phase. arm 2: After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the Treatment Phase.
Interventions: intervention 1: Suvorexant intervention 2: Dose-matched Placebo to Suvorexant
Intervention descriptions: intervention 1: Oral tablet (30 mg and 10 mg), administered daily before bedtime intervention 2: Oral tablet, administered daily before bedtime

Protocol documents:
Clinical trial NCT01048658
Conditions: Blood Loss Anesthesia
Keywords: Sevoflurane anesthesia abortion blood loss
Sponsor: Oregon Health and Science University
Start date: 2009-09-01; Completion date: 2011-08-01
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Sevoflurane is an FDA-approved anesthetic drug commonly used for anesthesia during second trimester abortion procedures. It has a few advantages, including ease of use by the anesthesia provider. However, the literature suggests that when used in doses higher than those used at Oregon Health \& Science University (OHSU) and Lovejoy, it is associated with an increase in the risk of bleeding. The investigators study aims to test whether the lower dose used at OHSU and Lovejoy during second trimester abortion procedures causes any difference in blood loss, when compared to similar abortion procedures for which this drug is not used.

Detailed description:
This study seeks to examine the bleeding complications associated with use of sevoflurane in general anesthesia regimens for second trimester abortion procedures and assess anesthesia providers' use and beliefs regarding possible risks associated with newer inhalational agents such as sevoflurane in this setting. Participants' anesthesia will either be intravenous (IV) propofol, IV midazolam, IV fentanyl and nitrous oxide or this same regimen combined with sevoflurane during maintenance of anesthesia. Procedural outcomes, specifically those related to bleeding complications, including need to intervene for excess blood loss, will be recorded and analyzed to establish if such a relationship between use of sevoflurane and excess blood loss exists.

Arms: arm 1: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure. arm 2: Subject receives standard of care drug regimens for anesthesia with this procedure.
Interventions: intervention 1: Sevoflurane intervention 2: No Sevoflurane
Intervention descriptions: intervention 1: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure. intervention 2: Subject only standard of care drug regimens for anesthesia with this procedure.

Protocol documents:
Clinical trial NCT01048788
Conditions: Cirrhosis
Keywords: Cirrhosis ascites Tolvaptan OPC-41061
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2009-12-01; Completion date: 2011-08-01
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
OPC-41061 will be orally administered at 7.5 mg/day for 7 days to cirrhosis patients with ascites despite having received conventional diuretic therapy. Based on the change in body weight, on Day 7 it will be decided whether to continue administration at the same dose or to increase the dose, and then OPC-41061 will be orally administered for an additional 7 days at either 7.5 mg/day or, if diuretic effect for the initial 7-day administration is insufficient, at an increased dose of 15 mg/day. Plasma drug level, efficacy, and safety of OPC-41061 by 14-day repeated administration will be investigated.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: OPC-41061
Intervention descriptions: intervention 1: OPC-41061 tablets will be orally administered once daily after breakfast at 7.5 mg on Day 1 to 7 and at either 7.5 or 15 mg on Day 8 to 14.

Protocol documents:
Clinical trial NCT01054729
Conditions: Hepatitis C
Keywords: Chronic Hepatitis C infection Genotype 1 HCV GT1 GT 1
Sponsor: Gilead Sciences
Start date: 2010-01-01; Completion date: 2011-08-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Participants with genotype 1 HCV infection were randomized to 1 of 3 sofosbuvir doses (100 mg, 200 mg, or 400 mg) or matching placebo once daily based upon stratification for IL28B status (CC or CT/TT). Placebo tablets were administered to participants receiving 100 mg active sofosbuvir (3 placebo tablets) and 200 mg active sofosbuvir (2 placebo tablets) in order to maintain the study blind. Participants received sofosbuvir/matching placebo from Day 0 to 27. Participants also received treatment with PEG+RBV starting on Day 0 of the study which continued for 48 weeks. Participants were evaluated for sustained virologic response (SVR) for an additional 24 weeks following completion of study treatment.

Detailed description:

Arms: arm 1: Participants received sofosbuvir 100 mg (1 x 100 mg tablet) and placebo to match sofosbuvir (3 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48) arm 2: Participants received sofosbuvir 200 mg (2 x 100 mg tablets) and placebo to match sofosbuvir (2 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48) arm 3: Participants received sofosbuvir 400 mg (4 x 100 mg tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48) arm 4: Participants received placebo to match sofosbuvir (4 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
Interventions: intervention 1: Sofosbuvir intervention 2: Placebo intervention 3: PEG intervention 4: RBV
Intervention descriptions: intervention 1: Sofosbuvir tablet(s) administered orally once daily intervention 2: Placebo to match sofosbuvir administered orally once daily intervention 3: Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection. intervention 4: Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).

Protocol documents:
Clinical trial NCT01059344
Conditions: Ulcerative Colitis
Keywords: Mesalamine Asacol Ulcerative colitis induction therapy acute disease mild to moderate Active Ulcerative Colitis (mild to moderate)
Sponsor: Tillotts Pharma AG
Start date: 2009-11-01; Completion date: 2011-08-01
Enrollment: 281 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to determine the efficacy of Asacol™ 4.8 g/day (800 mg tablets) to induce clinical and endoscopic remission after 6 weeks of treatment compared to placebo in subjects with active ulcerative colitis (UC).

Detailed description:
The 800 mg Asacol™ tablets from Tillotts Pharma AG are being marketed in over 30 countries, mainly in Europe and Asia. Approved dosages for the treatment of active UC are between 2.4 and 4.8 g/day in analogy to the approved 400 mg dosage form. The present trial is planned to generate efficacy data to support the safe use of a 4.8 g/day dose of the 800 mg dosage form in a well defined population of patients with mildly to moderately active UC. In keeping with the EMEA UC guideline the study will have a placebo-controlled 6 weeks induction treatment. After 6 weeks, treatment success will be evaluated using the modified UC disease activity index as primary efficacy measurement.

Arms: arm 1: 4.8g Mesalamin (800mg tablet) arm 2: 4.8g Placebo to Mesalamin (800 mg tablet)
Interventions: intervention 1: Mesalamin
Intervention descriptions: intervention 1: 4.8g/day, 800 mg tablets

Protocol documents: