ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01764022
Conditions: Human Epithelial Receptor (HER)-2 Positive Breast Cancer
Keywords: breast cancer trastuzumab
Sponsor: Biocad
Start date: 2012-10-01; Completion date: 2017-12-01
Enrollment: 225 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
BCD-022-02 is a double-blind randomized clinical trial comparing efficacy of BCD-022 (INN: trastuzumab) and paclitaxel to Herceptin and paclitaxel in HER2-positive metastatic breast cancer with pharmacokinetics substudy. The purpose of the study is to demonstrate the non-inferiority of efficacy and safety of BCD-022 compared to Herceptin. Also study includes pharmacokinetics assessment.

Detailed description:
The study is based on the hypothesis of equivalence of BCD-022 (trastuzumab by JSC BIOCAD, Russia) in combination with paclitaxel used as the therapy of inoperable or metastatic HER2(+) breast cancer in comparison with Herceptin® (F. Hoffmann-La Roche Ltd., Switzerland) in combination with paclitaxel. The objectives of the study is to evaluate efficacy, safety and pharmacokinetics of BCD-022 compared with reference trastuzumab by 1. overall response rate and other efficacy parameters; 2. incidence and severity of adverse events; 3. serum concentration after the first and multiple trastuzumab administration; 4. incidence and concentration of anti-trastuzumab antibodies.

Arms: arm 1: BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations). arm 2: In this arm patients will receive 6 courses of treatment with Herceptin® (F. Hoffmann-La Roche Ltd., Switzerland) in combination with paclitaxel. Patients will receive Herceptin® at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
Interventions: intervention 1: Trastuzumab intervention 2: Paclitaxel
Intervention descriptions: intervention 1: Patients will receive 6 courses of trastuzumab in combination with paclitaxel. Trastuzumab will be administered at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations) as 90 min intravenous infusion every 3 weeks (on Day 1 of each cycle). intervention 2: Paclitaxel will be administered at a dose of 175 mg/m2 every 3 weeks (on Day 1 of each course) as 3 hour intravenous infusion (6 courses totally).

Protocol documents:
Clinical trial NCT01989910
Conditions: HIV-1 Infection
Keywords: Efavirenz Raltegravir Combination antiretroviral therapy
Sponsor: Taipei Veterans General Hospital, Taiwan
Start date: 2013-09-01; Completion date: 2017-12-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A pilot study to compare the efficacy and safety of raltegravir-based versus efavirenz-based combination therapy in treatment-naïve patients with HIV-1 infection.

Detailed description:
A single-center, prospective, randomized, open label, parallel study to compare the efficacy and safety of raltegravir-based versus efavirenz-based plus optimal nucleoside reverse-transcriptase inhibitors(NRTIs) backbone combination therapy in treatment-naïve patients with HIV-1 infection.

Arms: arm 1: Raltegravir 400mg oral twice daily arm 2: Efavirenz 600mg oral at bedtime
Interventions: intervention 1: Raltegravir intervention 2: Efavirenz
Intervention descriptions: intervention 1: Raltegravir 400mg oral twice daily intervention 2: Efavirenz 600mg oral at bedtime

Protocol documents:
Clinical trial NCT02349152
Conditions: Heart Diseases Hyperglycemia
Keywords: Cardiopulmonary bypass Heart surgery
Sponsor: Kathirvel Subramaniam
Start date: 2016-01-01; Completion date: 2017-12-01
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the effect of using remifentanil during cardiopulmonary bypass surgery to supress the hyperglycemic response in perioperative period. Half of the participants will receive continuous intravenous remifentanil during surgery, while the other half will receive intermittent intravenous fentanyl during surgery. Intermittent intravenous fentanyl administration is this institution's standard of care.

Detailed description:
Stress-induced hyperglycemia is a well-known phenomena that occurs during cardiopulmonary bypass surgery. Hyperglycemia increases the incidence of major adverse events and mortality in patients undergoing cardiac surgery.

Remifentanil, an ultra-short acting opioid analgesic, has been shown to reduce the stress response to cardiopulmonary bypass when compared to intermittent fentanyl and inhalation anesthesia. This in turn, will reduce the occurence of perioperative hyperglycemia, glycemic variability and insulin requirements in patients undergoing cardiac surgery.

NOTE;

Primary Outcome changed on 06/15/2015-Change Approved by University of Pittsburgh IRB on 06/22/2015- First patient enrolled January 2016.

Primary outcome measure; Percentage of patients with two or more than two intraoperative blood glucose levels more than 180 mg% in both groups will be estimated and the difference in this parameter between the two groups will form the primary outcome measure of this study.

Arms: arm 1: Half of subjects enrolled will be randomized to the remifentanil group arm 2: Half of subjects enrolled will be randomized to the fentanyl group
Interventions: intervention 1: Remifentanil intervention 2: Fentanyl
Intervention descriptions: intervention 1: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated. intervention 2: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.

Protocol documents:
Clinical trial NCT02524054
Conditions: Dyspnea
Keywords: Dyspnea Hospitalized patients Ambulatory outpatients Shortness of breath Chronic obstructive pulmonary disease Pulmonary disease
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2014-11-01; Completion date: 2017-12-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this protocol is to develop and test aerosol furosemide, as a treatment that has the potential to significantly improve symptom management and enhance the quality of care for patients with intractable dyspnea.

Detailed description:
This is the second study in a series of studies investigating the treatment effect of aerosolized furosemide on hospitalized patients and outpatients with intractable dyspnea. The study will focus on patients who experience intractable dyspnea at rest or with minimal activity, e.g., dressing, bathing, cooking, or walking stairs or short distances.

There are two parts to this study: Study 2a is a pilot study on 5-10 patients. These trials are not blinded or placebo controlled; the investigators will use them to discover practical problems, and take the information back to the laboratory to develop solutions. We enrolled 7 subjects for Study 2a.

Study 2b will a randomized, placebo - controlled, double- blind study on 25 - 40 patients. The two planned treatments will be aerosolized furosemide and aerosolized saline, and will be given to each patient on two separate days. We failed to reach our enrollment goal, and ultimately enrolled 17 subjects for participation in Study 2b.

Arms: arm 1: Subjects will inhale 40mg of furosemide aerosol over the course of 10-15 min. This will be a single, unblinded administration. arm 2: Inhalation of furosemide aerosol one one day then placebo saline aerosol on another day. Baseline measurement 15 min; Inhalation over the course of 10-15 min.; outcome measurement 15 min. Watch for adverse effects 2 hours. arm 3: Inhalation of saline aerosol one one day then furosemide aerosol on another day. Baseline measurement 15 min; Inhalation over the course of 10-15 min.; outcome measurement 15 min. Watch for adverse effects 2 hours.
Interventions: intervention 1: Furosemide intervention 2: Aerosolized saline
Intervention descriptions: intervention 1: 80 mg of Furosemide in 8ml saline will be aerosolized using ultrasonic screen nebulizers. Aerosol will be delivered using a clinical volume-control ventilator to regulate inspiratory flow and volume. intervention 2: 8ml saline will be aerosolized using ultrasonic screen nebulizers. Aerosol will be delivered using a clinical volume-control ventilator to regulate inspiratory flow and volume.

Protocol documents:
Clinical trial NCT02734238
Conditions: Caloric Restriction Exercise
Sponsor: Pennington Biomedical Research Center
Start date: 2016-04-01; Completion date: 2017-12-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to determine whether maintaining a eugonadal state, during severe, sustained energy deficit, attenuates physiological decrements, particularly the loss of lean body mass.

Detailed description:
This study will enroll up to 60 physically active men in a 3-phase randomized, placebo-controlled trial. After completing a 14-day (free-living, phase 1), energy-adequate, diet-acclimation phase (protein, 1.6 g∙kg-1∙d-1; fat 30% total energy intake, with remaining energy derived from carbohydrate), participants will be randomized to one of two experimental groups and undergo a 28-day (live-in, phase 2), 55% energy deficit phase: energy deficit alone (DEF) or energy deficit + exogenous testosterone (DEF+TEST). Recovery (free-living, phase 3) will be assessed after completing phase 2 to determine when body mass has been recovered within ± 2.5% of initial body mass (duration will vary, 42-day maximum for phase 3). This study will delineate the contribution of testosterone declines from the physical and mental demands encountered by Warfighters during military training and combat operations on complex markers of physiological and psychological status, addressing a direct, consistently observed, gap in knowledge.

Arms: arm 1: Participants randomly assigned to the control condition will be subject to exercise-induced energy expenditure resulting in a 55% energy deficit and will be administered sesame oil placebo injections during phase 2 of the trial. arm 2: Participants randomly assigned to the intervention condition will be subject to exercise-induced energy expenditure resulting in a 55% energy deficit and will be administered testosterone enanthate injections during phase 2 of the trial.
Interventions: intervention 1: Sesame Oil intervention 2: testosterone enanthate
Intervention descriptions: intervention 1: 200 mg sesame oil by intramuscular injection weekly on days 15, 21, 28, and 35 intervention 2: 200 mg testosterone enanthate by intramuscular injection weekly on days 15, 21, 28, and 35

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT02879747
Conditions: Short Stature
Keywords: treatment growth hormone childhood short stature
Sponsor: Göteborg University
Start date: 2003-12-01; Completion date: 2017-12-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective was to study whether normal growth velocity can be maintained with adapted GH dosage in GH treated prepubertal children who have responded to GH treatment with fulfilled catch up growth (=difference to target height reached, less than - 0.6 SDS).

Detailed description:
The aim of the trial is to study the effect of adapted GH treatment in order to find an individualized GH dose maintaining normal growth velocity close to target height SDS and normal metabolism after fulfilled catch up growth in prepubertal children treated with individual doses of GH within the trial 98-0198-003 (1). The overall aim is to find for the individual the lowest effective GH dose during maintenance period, maintaining normal growth velocity and metabolism, i.e. a satisfactory biological active dose.

Arms: arm 1: Unchanged dose Genotropin arm 2: reduced dose 50% Genotropin
Interventions: intervention 1: Genotropin
Intervention descriptions: intervention 1: Children were randomized to either decreased dose by 50% or unchanged dose after 2-3 years of Catch-up growth

Protocol documents:
Clinical trial NCT03022916
Conditions: Evaluation of Jublia on Nail Polish With Healthy Toenails
Keywords: toenail polish jublia
Sponsor: University of Alabama at Birmingham
Start date: 2015-09-01; Completion date: 2017-12-01
Enrollment: 5 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A recent publication using cadaver nails suggests that Jublia application has a negative effect on nail polish texture.

Detailed description:
It is believed that investigating the affect of Jublia is an important question with regards to how it affects how various nail polished and top coats will be used.

Arms: arm 1: One big toe will receive application of Efinaconazole Solution on top of nail polish (without the presence of a top coat or base coat) arm 2: Both big toes will use nail polish only arm 3: One big toe will receive application of Efinaconazole solution on top of nail polish with base coat and top coat. arm 4: One big toe will receive application of Efinaconazole solution on top of nail polish with top coat.
Interventions: intervention 1: Nail Polish + Efinaconazole Solution intervention 2: Nail polish intervention 3: Base Coat + Nail Polish + Top Coat + Efinaconazole Solution intervention 4: Nail Polish + Top Coat + Efinaconazole Solution
Intervention descriptions: intervention 1: Application of Jublia to the nail of one big toe on top of the nail polish intervention 2: Application of nail polish only to both big toe nails intervention 3: Application of Jublia to the nail of one big toe on top of the nail polish with layers of top coat and base coat intervention 4: Application of Jublia to the nail of one big toe on top of the nail polish with layer of top coat

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01080391
Conditions: Relapsed Multiple Myeloma
Keywords: Multiple Myeloma
Sponsor: Amgen
Start date: 2010-07-14; Completion date: 2017-12-05
Enrollment: 792 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting.

Detailed description:
This is a Phase 3, randomized, open-label, multicenter study comparing two treatment regimens for adults with relapsed multiple myeloma. Eligible subjects will be randomized in a 1:1 ratio to receive either the control Rd or CRd. Randomization will be stratified by β2 microglobulin levels (\< vs ≥ 2.5 mg/L), prior bortezomib (no vs yes), and prior lenalidomide (no vs yes). Participants will receive the treatment determined by randomization in 28-day cycles until disease progression or unacceptable toxicity (whichever occurs first).

Arms: arm 1: Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22. arm 2: Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, escalating to 27 mg/m² on days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 from cycle 1 through cycle 18 and from cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 from cycle 1 through cycle 18 and from cycle 19 and higher.
Interventions: intervention 1: Dexamethasone intervention 2: Lenalidomide intervention 3: Carfilzomib
Intervention descriptions: intervention 1: 40 mg orally or IV on days 1, 8, 15, 22 intervention 2: 25 mg orally on days 1-21 intervention 3: 20 mg/m², 27 mg/m² intravenously

Protocol documents:
Clinical trial NCT01594281
Conditions: Proliferative Diabetic Retinopathy (PDR)
Keywords: Panretinal photocoagulation Ranibizumab
Sponsor: Novartis Pharmaceuticals
Start date: 2012-12-11; Completion date: 2017-12-05
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the efficacy and safety of the anti-Vascular Endothelial Growth Factor (VEGF) agent ranibizumab (0.5 mg) with or without Panretinal laser photocoagulation (PRP) compared to PRP alone in patients with Proliferative Diabetic Retinopathy (PDR).

Detailed description:
A 12-month core phase was followed by a 12-month observational follow-up phase (physician's routine), for a planned individual study duration of 24-25 months. A separate informed consent was signed for the 12-month observational follow-up phase. This study was conducted in Germany.

Arms: arm 1: Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months) arm 2: Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures arm 3: Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
Interventions: intervention 1: Ranibizumab 0.5 mg intervention 2: Panretinal laser photocoagulation
Intervention descriptions: intervention 1: Pre-filled syringe for intravitreal injection intervention 2: PRP treatment following DRS guidelines

Protocol documents:
Clinical trial NCT00094328
Conditions: Puberty, Precocious
Keywords: Testotoxicosis Familial Male-limited Precocious Puberty (FMPP)
Sponsor: AstraZeneca
Start date: 2004-11-22; Completion date: 2017-12-06
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to investigate whether bicalutamide given in combination with anastrozole once daily for 12 months is effective in treating testotoxicosis in boys. Testotoxicosis is a condition that causes early puberty in boys including growth in height, and development of muscles and sexual organs .

Detailed description:

Arms: arm 1: Bicalutamide in combination with Anastrozole
Interventions: intervention 1: Bicalutamide intervention 2: Anastrozole
Intervention descriptions: intervention 1: oral intervention 2: oral

Protocol documents:
Clinical trial NCT00337103
Conditions: Metastatic Breast Cancer
Sponsor: Eisai Inc.
Start date: 2006-09-20; Completion date: 2017-12-11
Enrollment: 1276 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare E7389 versus capecitabine in patients with locally advanced or metastatic breast cancer who are refractory to the most recent chemotherapy. This is an open-label, randomized, two-parallel arm study. Patients will be randomized to receive either E7389 or capecitabine on a one-to-one ratio.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Eribulin Mesylate intervention 2: Capecitabine
Intervention descriptions: intervention 1: 1.4 mg/m\^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days intervention 2: Capecitabine 2.5 g/m\^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days

Protocol documents:
Clinical trial NCT01487265
Conditions: Non Small Cell Lung Cancer
Keywords: Erlotinib BKM120 NSCLC
Sponsor: SCRI Development Innovations, LLC
Start date: 2014-03-01; Completion date: 2017-12-11
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Preclinical data in lung cancer cell lines showed that EGFR mutation can potentially be a positive predictor for sensitivity to BKM120. Furthermore, when the erlotinib-resistant model H1975 (LR858 and T790M mutation) was treated with BKM120, significant tumor control was observed (Novartis internal data). Therefore, combining BKM120 with erlotinib could potentially down-modulate PI3K-Akt activity resulting in a synergistic effect on cell growth inhibition and enhancing the response to erlotinib.

Detailed description:
This is a multicentered, open-label, non-randomized Phase II study of BKM120 and erlotinib in patients with advanced NSCLC previously sensitive to erlotinib. After six patients are enrolled and complete one treatment cycle a safety analysis of adverse events (AEs) will be conducted to assure there are no unexpected or prohibitive toxicities of the combination. The planned study enrollment will continue to up to 37 patients. Duration of a patient's participation in the study will vary. Treatment will continue as long as the patient is benefitting from the treatment, has no evidence of disease progression, and does not meet any criteria for discontinuation or withdrawal.

Arms: arm 1: Cycle 1: BKM120 80 mg PO daily; Erlotinib 100mg PO daily

Cycles 2 and beyond: BKM120 100 mg PO daily; Erlotinib 100mg PO daily
Interventions: intervention 1: BKM120 and Erlotinib
Intervention descriptions: intervention 1: BKM120 and Erlotinib will be given once daily. Erlotinib 100 mg PO will be administered. During Cycle 1-Week 1 all patients will receive 80 mg PO daily BKM120. After the first week of Cycle 1, the dose of BKM120 will escalate to 100 mg PO daily and treatment will continue as long as there are no unexpected or prohibitive toxicities, or disease progression.

Protocol documents:
Clinical trial NCT02008916
Conditions: Spondylitis, Ankylosing
Keywords: AIN457, ankylosing spondylitis, chronic inflammatory disease, inflammatory back pain, secukinumab, self-injection
Sponsor: Novartis Pharmaceuticals
Start date: 2014-01-14; Completion date: 2017-12-11
Enrollment: 226 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy.

Detailed description:

Arms: arm 1: Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study. arm 2: Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study. arm 3: Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.
Interventions: intervention 1: Secukinumab intervention 2: Placebo secukinumab
Intervention descriptions: intervention 1: AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17). intervention 2: Placebo to AIN457 (Secukinumab)

Protocol documents: