ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01991483
Conditions: Renal Insufficiency, Chronic Kidney Disease, Chronic
Sponsor: Eli Lilly and Company
Start date: 2013-12-01; Completion date: 2015-10-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety of LY2928057 and how LY2928057 affects hemoglobin in hemodialysis participants. This study will involve multiple doses of LY2928057 given during a 6 week period either after a participant discontinues or reduces treatment to stimulate red blood cells. This study will last up to 26 weeks for each participant.

Detailed description:

Arms: arm 1: Multiple doses of LY2928057 administered intravenously (IV) either once every 2 weeks (Q2W) or once per week (QW) for 6 weeks. Participants discontinued their personal physician-prescribed erythropoiesis stimulating agent (ESA) before treatment. arm 2: Multiple doses of LY2928057 administered IV either Q2W or QW for 6 weeks. Participants reduced their personal physician-prescribed ESA dose before treatment. arm 3: Multiple doses of placebo administered IV either Q2W or QW for 6 weeks. Participants discontinued their personal physician-prescribed ESA dose before treatment. arm 4: Multiple doses of placebo administered IV either Q2W or QW for 6 weeks. Participants reduced their personal physician-prescribed ESA dose before treatment.
Interventions: intervention 1: LY2928057 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered intravenously intervention 2: Administered intravenously

Protocol documents:
Clinical trial NCT02007252
Conditions: Abdominal Aortic Aneurysm (AAA)
Keywords: Abdominal Aortic Aneurysm AAA IL-1b Abdominal ultrasound
Sponsor: Novartis Pharmaceuticals
Start date: 2013-12-01; Completion date: 2015-10-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to assess the safety, tolerability and efficacy of ACZ885 on aneurysmal growth rate in subjects with abdominal aortic aneurysms (AAA). The purpose of the study was to provide data to enable decisions regarding the further development of ACZ885 for subjects with abdominal aortic aneurysms. The design of this study addressed the primary objective of evaluating the change in aneurysmal size in subjects with AAA as a result of treatment with ACZ885.

Detailed description:

Arms: arm 1: Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months. arm 2: Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
Interventions: intervention 1: ACZ885 intervention 2: Placebo
Intervention descriptions: intervention 1: ACZ885 150 mg liquid pre-filled syringes were administered s.c.. intervention 2: Matching placebo liquid pre-filled syringes were administered s.c..

Protocol documents:
Clinical trial NCT02014363
Conditions: Major Depressive Disorder
Sponsor: e-Therapeutics PLC
Start date: 2013-10-01; Completion date: 2015-10-01
Enrollment: 164 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate that the antidepressant activity of ETS6103 is not inferior to amitriptyline in subjects who have an unsatisfactory response to / are resistant to treatment with SSRIs.

Detailed description:

Arms: arm 1: ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks). arm 2: ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks). arm 3: Amitriptyline tablets (encapsulated) Standard dosing regime arm 4: Citalopram tablets:

Standard dosing regime
Interventions: intervention 1: ETS6103 (low dose) intervention 2: ETS6103 (high dose) intervention 3: Amitriptyline
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02021942
Conditions: Primary Inoperable Thymoma Local Recurrent Thymoma
Keywords: primary inoperable thymoma local recurrent thymoma reduction of tumor size SOM230 LAR
Sponsor: Prof. Dr. Berthold Schalke
Start date: 2012-03-01; Completion date: 2015-10-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a monocenter, single-arm, open label phase II trial evaluating the effect of SOM230 LAR in adult patients with inoperable primary thymoma and thymoma metastasis (Masaoka II-IVa). SOM230 LAR in a dosage of 60 mg is administered i.m. once every 4 weeks. The purpose of this trial is a proof of concept.

Detailed description:

Arms: arm 1: SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
Interventions: intervention 1: SOM230 LAR
Intervention descriptions: intervention 1: SOM230 LAR in a dosage of 60 mg is administered i.m. once every 4 weeks.

Protocol documents:
Clinical trial NCT02023099
Conditions: Chronic Hepatitis C Infection
Keywords: Hepatitis C Genotype 1b Cirrhotic Treatment Experienced Treatment Naive Japanese ombitasvir paritaprevir ritonavir VIEKIRAX Combination Tablets
Sponsor: AbbVie
Start date: 2013-12-01; Completion date: 2015-10-01
Enrollment: 363 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 3, double-blinded, multicenter study. The study will consist of 2 substudies: Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2 (SS2) will be open label and enroll subjects with compensated cirrhosis.

Detailed description:

Arms: arm 1: Double-blind (DB) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents \[2-DAA\]) once daily (QD) for 12 weeks in participants without cirrhosis arm 2: DB placebo QD for 12 weeks followed by open-label (OL) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis arm 3: OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
Interventions: intervention 1: ABT-450/r/ABT-267 intervention 2: Placebo
Intervention descriptions: intervention 1: Tablet; ABT-450 coformulated with ritonavir and ABT-267 intervention 2: Tablet

Protocol documents:
Clinical trial NCT02024646
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis Brodalumab AMG 827
Sponsor: Bausch Health Americas, Inc.
Start date: 2014-03-01; Completion date: 2015-10-01
Enrollment: 484 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate the efficacy of brodalumab compared to placebo at week 16. The safety objective of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.

Detailed description:

Arms: arm 1: Administered via subcutaneous injections. arm 2: Administered via subcutaneous injection. arm 3: Administered via subcutaneous injection until week 24.
Interventions: intervention 1: 210 mg brodalumab intervention 2: 140 mg brodalumab intervention 3: Placebo
Intervention descriptions: intervention 1: 210 mg brodalumab administered via subcutaneous injection. intervention 2: 140 mg brodalumab administered via subcutaneous injection. intervention 3: Placebo administered via subcutaneous injection until week 24.

Protocol documents:
Clinical trial NCT02025075
Conditions: Intraoperative Complications Postoperative Complications Laparoscopy Surgical Complications From General Anesthesia Ventilator-Induced Lung Injury
Keywords: Tomography Oximetry Echocardiography
Sponsor: Massachusetts General Hospital
Start date: 2014-01-01; Completion date: 2015-10-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this study is to investigate the effect of depth of neuromuscular block (NMB) on global and regional (dependent versus nondependent) respiratory mechanics during laparoscopic surgery. Furthermore, we will investigate if the level of NMB influences intraoperative hemodynamic and cerebral oxygenation.

Detailed description:

Arms: arm 1: Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor). arm 2: Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).
Interventions: intervention 1: Rocuronium
Intervention descriptions: intervention 1: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB).

Protocol documents:
Clinical trial NCT02029495
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis Brodalumab AMG 827
Sponsor: Bausch Health Americas, Inc.
Start date: 2014-03-01; Completion date: 2015-10-01
Enrollment: 478 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis.

Detailed description:
The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate the efficacy of brodalumab compared to placebo at week 16 and week 24. The safety objective of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.

Arms: arm 1: Administered via subcutaneous injections arm 2: Administered via subcutaneous injection arm 3: Administered via subcutaneous injection until week 24.
Interventions: intervention 1: 210 mg brodalumab intervention 2: 140 mg brodalumab intervention 3: Placebo
Intervention descriptions: intervention 1: 210 mg brodalumab administered via subcutaneous injection intervention 2: 140 mg brodalumab administered via subcutaneous injection intervention 3: Placebo administered via subcutaneous injection until week 24.

Protocol documents:
Clinical trial NCT02039427
Conditions: Anesthesia Intubation Complication Tracheal Disease
Keywords: Sore throat Hoarseness Intubation Thyroidectomy Ketorolac Dexamethasone
Sponsor: Yeungnam University College of Medicine
Start date: 2014-01-01; Completion date: 2015-10-01
Enrollment: 192 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Sore throat is one of most frequent complaints related to general anesthesia with tracheal intubation. Although sore throat is regarded as a minor and short-lasting discomfort after surgery, its incidence and intensity in high risk patients such as female gender, head and neck surgery and difficult laryngoscopy or intubation may attribute to prolong postoperative recovery and give patient dissatisfaction.

Even though the pathophysiology of post-intubation airway symptoms is not completely clarified yet, the mucosal damage related inflammation at the cuff of endotracheal tube has been thought to be an essential trigger. Thus anti-inflammatory medication has been commonly used strategy to prevent postoperative airway discomfort after intubation. The preoperative administration of dexamethasone has been reported to reduce the incidence and severity of postoperative sore throat, but it is accompanied with the adverse effects such as hyperglycemia, delayed wound healing and increased infection in surgical patients. Ketorolac, non-steroidal anti-inflammatory drug (NSAID), is an analgesic that commonly used for postoperative pain control and has anti-inflammatory effect.

Therefore, the investigator designed to evaluate the effect of ketorolac on sore throat in comparison to dexamethasone after thyroidectomy in female adult patients

Detailed description:
Ketorolac, NSAID, has not been evaluated as a pharmacologic strategy to reduce postoperative sore throat yet. The investigator will explore how the analgesic and anti-inflammatory effects of ketorolac influence airway symptoms following general anesthesia with tracheal intubation.

Arms: arm 1: Normal saline(Placebo) 2 ml 5 min before induction Normal saline 2 ml 10 min before end of surgery arm 2: Ketorolac 30 mg 5 min before induction Normal saline 2 ml 10 min before end of surgery arm 3: Normal saline 2 ml 5 min before induction Ketorolac 30 mg 10 min before end of surgery arm 4: Dexamethasone 10 mg (total volume 2 ml) 5 min before induction Normal saline 2 ml 10 min before end of surgery
Interventions: intervention 1: Ketorolac intervention 2: Dexamethasone intervention 3: Placebo
Intervention descriptions: intervention 1: ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml intervention 2: dexamethasone acetate10 mg : total volume of 2 ml intervention 3: Normal saline 2 ml

Protocol documents:
Clinical trial NCT02057237
Conditions: Prostate Cancer
Sponsor: University Health Network, Toronto
Start date: 2013-09-01; Completion date: 2015-10-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
1. The primary objective of this study is to assess the feasibility of treating patients with metastatic castration resistant prostate cancer with mitotane. Secondary objectives are to assess safety and tolerability as well as response rate of therapy
2. To assess the toxicity of Mitotane in men with HRPC
3. To assess the relationship between baseline serum adrenal androgens and their response to Mitotane

Detailed description:
All patients will undergo pre-study assessment for symptoms, performance status, ECG, CT abdomen/pelvis, Bone scan, Complete blood count tests(hematology) , Biochemistry tests like serum electrolytes, liver function tests, coagulation profile, testosterone and PSA tests.

Mitotane will be administered 1.5g daily escalation to maximum of 5 g daily then adjusted according to serum levels and tolerability

Physical examinations, hematology, biochemistry tests, and toxicity evaluations will be measured throughout patients on protocol treatment

Mitotane serum level will be analyzed every second cycle

Research bloods include; ACTH, cortisol, deoxycorticosterone, aldosterone, corticosterone, and testosterone, androstenedione, dehydroepiandrostenedione (DHEA), DHEA sulfate (DHEA-S) and estradiol will be collected only in cycle 1,3 and 5

Arms: arm 1: Mitotane will be administered on an outpatient or inpatient basis.
Interventions: intervention 1: Mitotane
Intervention descriptions: intervention 1: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily

Protocol documents:
Clinical trial NCT02072096
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2014-02-01; Completion date: 2015-10-01
Enrollment: 192 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to compare the benefits and risks associated with the use of 2 treatment strategies to lower blood sugar in participants aged 65 and older with T2DM. One strategy is based on the use of oral and injectable medications that only reduce blood sugar (glucose) when it is high. The other strategy is based on non-glucose dependent agents. The trial will last up to 72 weeks for each participant.

Detailed description:

Arms: arm 1: Participants may receive oral and injectable (glucagon-like peptide-1 receptor agonists \[GLP-1 RA\]) therapies that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks. arm 2: Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Insulin glargine is titrated according treatment algorithm. Treatment may last up to 72 weeks.
Interventions: intervention 1: Glimepiride intervention 2: Metformin intervention 3: Pioglitazone intervention 4: Acarbose intervention 5: Linagliptin intervention 6: Sitagliptin intervention 7: Liraglutide intervention 8: Insulin Glargine intervention 9: Exenatide once weekly (QW) intervention 10: Exenatide twice daily (BID)
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally intervention 4: Administered orally intervention 5: Administered orally intervention 6: Administered orally intervention 7: Administered subcutaneously (SC) intervention 8: Administered SC intervention 9: Administered SC intervention 10: Administered SC

Protocol documents:
Clinical trial NCT02079766
Conditions: Chronic Traumatic Encephalopathy
Sponsor: Avid Radiopharmaceuticals
Start date: 2014-06-01; Completion date: 2015-10-01
Enrollment: 41 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will explore the use of flortaucipir as a biomarker for chronic traumatic encephalopathy (CTE) and examine the relationship between clinical presentation and tau deposition.

Detailed description:

Arms: arm 1: Flortaucipir PET scans in subjects at high risk of developing CTE (former National Football League players) arm 2: Flortaucipir PET scans in former non-contact athletes
Interventions: intervention 1: florbetapir F 18 intervention 2: Flortaucipir F18
Intervention descriptions: intervention 1: 370 megabecquerel (MBq) IV single-dose intervention 2: 370 megabecquerel (MBq) IV single-dose

Protocol documents:
Clinical trial NCT02084238
Conditions: Systemic Lupus Erythematosus
Keywords: SLE, IL-2
Sponsor: Peking University People's Hospital
Start date: 2013-08-01; Completion date: 2015-10-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical study will test the efficacy and safety of low dose IL-2 treatment in Systemic lupus erythematosus.

Detailed description:
Systemic lupus erythematosus (SLE) is a chronic autoimmune syndrome affecting various organs. While available therapies, such as corticosteroids and immunosuppressive agents have improved the outcome of patients, there remains a significant unmet need for safe and more effective treatments. Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). We hypothesized that low-dose IL-2 could be a novel therapy in active SLE patients.

This is a single center, uncontrolled, open-label study to assess the efficacy/safety of low dose IL-2 plus standard therapy in active SLE.

Methods: Each SLE patients (n=40) with Scores\>=8 on the Safety of Estrogens in Lupus Erythematosus National Assessment (AELENA) version of the SLE Disease Activity Index (SLEDAI) that was refractory or relaps to glucocorticoid therapy received low-dose IL-2 (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3-6 cycles according to the situation of the disease. The end points were safety and clinical and immunologic response.

Expected Results: This trail will define low-dose IL-2 plus standard therapy is efficacy and safety with active lupus patients, which could be relevant to the amelioration the abnormity of T help cells in SLE patients.

Arms: arm 1: Interleukin-2 to treat activated SLE.
Interventions: intervention 1: Interleukin-2
Intervention descriptions: intervention 1: Patients receive low dose recombinant human Interleukin-2（HrIL-2） (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3-6 courses according to the situation of the disease.

Protocol documents:
Clinical trial NCT02085161
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2014-03-01; Completion date: 2015-10-01
Enrollment: 304 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of the study are to explore the effect of treatment with orally inhaled tiotropium + olodaterol fixed dose combination with and without exercise training, and tiotropium comparing to placebo, on top of behavioural modification in improving exercise capacity in patients with COPD

Detailed description:

Arms: arm 1: patient will receive placebo once daily, 2 puffs in the morning arm 2: patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily, 2 puffs in the morning arm 3: patient will receive tiotropium 5 mcg once daily, 2 puffs in the morning arm 4: patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily, 2 puffs in the morning
Interventions: intervention 1: placebo to tiotropium + olodaterol intervention 2: tiotropium+olodaterol intervention 3: tiotropium +olodaterol intervention 4: tiotropium
Intervention descriptions: intervention 1: comparator intervention 2: tiotropium 5 mcg once daily intervention 3: olodaterol 5 mcg once daily fixed dose combination intervention 4: tiotropium 5 mcg once daily fixed dose combination

Protocol documents:
Clinical trial NCT02111200
Conditions: Urea Cycle Disorders, Inborn
Keywords: urea cycle disorders
Sponsor: Baylor College of Medicine
Start date: 2014-09-01; Completion date: 2015-10-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators will study and compare how effectively sodium phenylbutyrate, sodium benzoate, and a combination of the two, help excrete nitrogen in healthy volunteers. Subject participation will require three, separate, four-day study periods at least one week apart. During one study period (also called a treatment arm), subjects will take sodium phenylbutyrate; during another they will take sodium benzoate; during another they will take a combination of the two medications.

We expect to find that phenylbutyrate is more effective at removing nitrogen than benzoate or a combination of the two.

Detailed description:

Arms: arm 1: Sodium benzoate 5.5 g/m2/day divided into three equal doses per day (maximum dose 12 g/day) for 3 days arm 2: Sodium phenylbutyrate 7.15 g/m2/day divided into three equal doses per day (maximum dose of 20 g/day) for 3 days arm 3: Sodium Phenylbutyrate 3.575 g/m2/day and Sodium Benzoate 2.75 g/m2/day will be given in three equal doses per day for 3 days
Interventions: intervention 1: Sodium Benzoate intervention 2: Sodium Phenylbutyrate
Intervention descriptions: intervention 1: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days. intervention 2: Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.

Protocol documents: