ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01972776
Conditions: COPD
Keywords: COPD, inflammation, small airways, LCI, PFTs, lung heterogeneity
Sponsor: Novartis Pharmaceuticals
Start date: 2013-11-01; Completion date: 2015-05-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a 2 Part study. Part 1 was a safety and tolerability study in GOLD I-III COPD patients. Part 2 was an efficacy study in GOLD I-III COPD patients.

Detailed description:
Part 1 was a double-blind, randomized, placebo-controlled, non-confirmatory study in chronic bronchitis COPD patients. Part 1 consisted of up to 27-days of screening period, one baseline period of 1 day, 13 days of bid dosing with study treatment, morning only treatment on Day 14, follow up visits on Days 15 - 17, followed by a Study Completion evaluation. Twenty-seven patients were randomized in a 3:1 ratio to 3 cohorts..

Part 2 was a double-blind, randomized, placebo-controlled, non-confirmatory study in Gold spirometry grades I-III COPD patients. Part 2 consisted of up to 20 days of screening period, a 9 day run in period, one baseline period of 1 day, 55 days of bid dosing, morning only dosing on Day 56, followed by Study Completion evaluation. It was planned to randomize 90 patients in a 2:1 ratio, but part 2 was terminated after 21 patients were enrolled. Three of the 21 part 2 patients experienced moderate to severe (up to 17-fold) asymptomatic and reversible elevation of liver transaminase levels after 3 weeks of treatment with QBM076 150 mg twice daily. Two of these patients had liver transaminase levels high enough to be reported as serious adverse events suspected to be related to the study drug.

Arms: arm 1: Participants received QBM076 25 mg twice daily (bid) for 14 days. arm 2: Participants received QBM076 75 mg bid for 14 days. arm 3: Participants received QBM076 150 mg bid for 14 days. arm 4: Participants in each cohort received matching placebo for 14 days. arm 5: Participants received QBM076 150 mg bid for 8 weeks. arm 6: Participants received matching placebo for 8 weeks.
Interventions: intervention 1: QBM076 intervention 2: Placebo
Intervention descriptions: intervention 1: Supplied in 25 mg and 75 mg capsules intervention 2: Matching placebo capsules

Protocol documents:
Clinical trial NCT01976988
Conditions: Venous Thromboembolism
Sponsor: Cedars-Sinai Medical Center
Start date: 2013-09-01; Completion date: 2015-05-01
Enrollment: 410 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients undergoing major colorectal surgery are at increased risk for VTE (deep venous thrombosis) compared with patients undergoing other general surgical procedures (Bergqvist et al. Dis. Col. Rectum. 2006; 49: 1620-1628.)

The reported incidence of symptomatic VTE after colorectal surgery is approximately 4% (Monn, F. et al. JACS. 216; 2013: 395-401). However, the reported incidence of VTE after colorectal surgery in prospectively followed patients managed with perioperative venous thromboprophylaxis undergoing screening venography prior to hospital discharge ranges from 9 to 20% (Bergovist et al. NEJM 346; 2002: 975-980; McLeod et al. Ann. Surg. 233; 2000: 438-444; ENOXACAN Study group. Brit. J. Surg. 84; 1997: 1099-1103.

The Surgical Care Improvement Project (SCIP) and the American College of Chest Physician (ACCP) guidelines recommend that venous thromboprophylaxis be initiated within 24 hours of surgery. However, it is believed that deep venous thrombosis occurs during surgery, rather than in the postoperative period, justifying preoperative initiation of venous thromboprophylaxis. This practice is accompanied with a theoretically higher risk of bleeding complications.

Currently there is no consensus on the precise timing of VTE prophylaxis after major colorectal surgery, as demonstrated by the vague guidelines established by the ACCP and SCIP. Current studies on VTE prophylaxis report preoperative initiation of VTE prophylaxis. However, majority of surgeons at our institution begin heparin postoperatively given concern for bleeding complications with preoperative dosing of heparin.

The purpose of this study is to prospectively evaluate the incidence of VTE and major bleeding complications in patients undergoing major colorectal surgery who are treated with preoperative or postoperative venous thromboprophylaxis and to help establish more stringent guidelines on the optimal timing of VTE prophylaxis.

Detailed description:

Arms: arm 1: Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course arm 2: Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course
Interventions: intervention 1: Heparin
Intervention descriptions: intervention 1: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course

Protocol documents:
Clinical trial NCT01990677
Conditions: Central Serous Chorioretinopathy
Keywords: Central Serous Chorioretinopathy csr cscr eplerenone vision choroid retina acute chronic
Sponsor: Wills Eye
Start date: 2013-10-01; Completion date: 2015-05-01
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
To test the effect oral eplerenone versus placebo in patients with central serious chorioretinopathy .

Detailed description:
To evaluate the effect of oral eplerenone compared to placebo in patients with central serous chorioretinopathy (CSCR) on sub-foveal (small part of retina) fluid using optical coherence tomography (OCT).

Arms: arm 1: Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day. arm 2: Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient. arm 3: Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 28 days. Throughout the 28 day treatment period, dosage will be adjusted based on serum potassium and creatine levels from blood draws done on Day 12. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day. arm 4: Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 28 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.
Interventions: intervention 1: 25mg Eplerenone intervention 2: Placebo
Intervention descriptions: intervention 1: Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo intervention 2: Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo.

Protocol documents:
Clinical trial NCT02000154
Conditions: Myelodysplastic Syndrome
Sponsor: SymBio Pharmaceuticals
Start date: 2014-12-01; Completion date: 2015-05-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an extension study study to investigate long term safety of SyB L-1101 when administered intravenously every 4 weeks to the patients who have completed 8 cycles in the study 2011005 whose purpose is to investigate tolerability of SyB L-1101 when administered intravenously in patients with recurrent/relapsed or refractory myelodysplastic syndrome. Antitumor effects will also be investigated in this study.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: SyB L-1101
Intervention descriptions: intervention 1: SyB L-1101 (rigosertib sodium) will be administered intravenously 72 continuous hours (3 days), followed by 25-day observation period. The treatment period of 28 days (3 days of administration + 25 days of observation) constitutes 1 cycle. The dose at cycle 8 in the study 2011005 will be the dose (if needed, the dose can be reduced) at the first cycle in this study (cycle 9). From cycle 10 on, the dose of SyB L-1101 will be reduced, delayed, or discontinued according to adverse events and results of observation at the previous cycle.

Protocol documents:
Clinical trial NCT02003391
Conditions: Open Angle Glaucoma Ocular Hypertension
Keywords: Open Angle Glaucoma Ocular Hypertension Intraocular Pressure
Sponsor: Alcon Research
Start date: 2013-12-01; Completion date: 2015-05-01
Enrollment: 157 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate superior intraocular pressure (IOP) control with travoprost 0.004% / timolol 0.5% compared to beta-blocker monotherapy in participants with open-angle glaucoma or ocular hypertension.

Detailed description:

Arms: arm 1: Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution, 1 drop instilled in the study eye once daily (evening) for 8 weeks. arm 2: Participant's current beta-blocker monotherapy, 1 drop instilled in the study eye twice daily (morning and evening) for 4 weeks, followed by travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution, 1 drop instilled in the study eye once daily (evening) for 4 additional weeks.
Interventions: intervention 1: Beta-blocker monotherapy intervention 2: Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution
Intervention descriptions: intervention 1: Per participant's current prescribed therapy intervention 2: None

Protocol documents:
Clinical trial NCT02057666
Conditions: Prostatic Neoplasms, Castration-Resistant
Keywords: CRPC Metastatic Chemotherapy naïve Chemo-naïve Prostate cancer mCRPC Chemotherapy-naïve Chemo naïve
Sponsor: Ipsen
Start date: 2014-01-01; Completion date: 2015-05-01
Enrollment: 146 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to confirm the effect of tasquinimod in delaying disease progression or death as compared with placebo in chemo-naïve patients with metastatic castrate-resistant prostate cancer (mCRPC).

Secondary objectives included further evaluation of the safety profile of tasquinimod, comparison of clinical benefits (such as overall survival and symptoms) of tasquinimod with placebo, to evaluate the quality of life impact and to determine the pharmacokinetics of tasquinimod.

Detailed description:
The study involved a 4-week Screening Period, Baseline Visit (Day 1) where the patient was randomised, followed by a Double Blind Treatment Period. Patients initially received tasquinimod (or corresponding placebo) at a 0.25 mg/day dose which was then titrated through 0.5 mg/day (from Day 15) to a maximum of 1 mg/day (from Day 29). If tolerability issues arose at 0.5 or 1 mg/day, patients had their dose reduced to 0.25 or 0.5 mg/day, respectively. The Double Blind Treatment Period continued until the death of the patient or any criterion for withdrawal from study treatment was reached. Any placebo treated patients with radiological disease progression confirmed by the central imaging assessment, who remained asymptomatic or mildly symptomatic were, at the Investigator's discretion, given the option to continue on active treatment (tasquinimod) during an Open-Label Treatment Period, following the same titration rule described above until progression under active treatment. All other patients stopped study treatment.

An End-of-Study Treatment/Withdrawal Visit was to be performed within 14 days after the last dose of study treatment and patients were then to be followed up every 6 months until 80% of the patients had died or 2 years after the last patient was randomised, whichever occurred last.

A PK ancillary study was to be performed in a subgroup of 12 Asian-Chinese patients before randomisation; however, due to the early termination of this study, only some samples were analysed and no PK analyses were performed.

Arms: arm 1: One capsule (0.25, 0.50 or 1 mg), taken orally once a day with water and food (preferably the main evening meal). arm 2: One capsule, taken orally once a day with water and food (preferably the main evening meal).
Interventions: intervention 1: Tasquinimod intervention 2: Placebo
Intervention descriptions: intervention 1: A patient initially received a 0.25 mg/day dose which was then titrated through 0.5 mg/day (from Day 15) to a maximum of 1 mg/day (from Day 29). If tolerability issues arose at 0.5 or 1 mg/day, patients had their dose reduced to 0.25 or 0.5 mg/day, respectively. intervention 2: Placebo capsules were identical to tasquinimod capsules in appearance and excipients but excluded the active compound (tasquinimod).

Protocol documents:
Clinical trial NCT02087176
Conditions: Previously Treated Non Small Cell Lung Cancer
Keywords: NSCLC
Sponsor: AstraZeneca
Start date: 2014-03-01; Completion date: 2015-05-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Lead-in Phase II Multicentre, Randomised, Double-Blind Study Comparing AZD1775 plus antimitotic agent and Placebo plus an antimitotic agent in Previously Treated Non-Small-Cell Lung Cancer Patients

Detailed description:
This multicentre trial consists of an open-labelled single cohort lead-in (Part A) followed by a phase II double-blind, randomised, placebo-controlled comparison of AZD1775 (or placebo) and an antimitotic agent. Review by a central laboratory of fresh tumour or archival tumour samples will be required prior to study entry to assess TP53 mutation status. However, subjects will be allowed to enter the single cohort (Part A) regardless of TP53 mutation status (wild-type or mutant). In addition, patients in the single cohort Part A treatment group will be asked to consent to limited sample collections for assessment of pharmacokinetic parameters.

Arms: arm 1: AZD 1775, antimitotic agent + pegfilgrastim 21 day Cycle, maximum of 4 cycles arm 2: Placebo + antimitotic+pegfilgrastim 21 day cycle, maximum of 4 cycles
Interventions: intervention 1: AZD1775 intervention 2: AZD1775 Placebo intervention 3: Antimitotic Agent intervention 4: pegfiligrastim
Intervention descriptions: intervention 1: AZD 1775 + antimitotic agent+ pegfilgrastim, restage every 2 cycles; continue until disease progression or unacceptable toxicity intervention 2: Placebo (to match dose) + antimitotic+ pegfilgrastim, restage every 2 cycles; continue until disease progression or unacceptable toxicity intervention 3: The antimitotic is a drug that stops cells from dividing. This leads to cell death. Because cancer cells divide faster than normal cells, they are more likely than normal cells to be affected by this drug. intervention 4: Pegfilgrastim is a man-made version of a protein called granulocyte-colony stimulating factor (G-CSF). This protein is made by cells in the body to stimulate the bone marrow to make more infection-fighting white blood cells.Pegfilgrastim is made by attaching filgrastim to a molecule called polyethylene glycol (PEG). This addition helps it stay in the body longer than filgrastim, which means it can be given less often.

Protocol documents:
Clinical trial NCT02090764
Conditions: Impetigo
Sponsor: Ferrer Internacional S.A.
Start date: 2014-06-01; Completion date: 2015-05-01
Enrollment: 412 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is multicenter, randomised, placebo controlled, parallel, double blinded , superiority clinical study comparing ozenoxacin cream versus placebo, in patients with a clinical diagnosis of non-bullous or bullous impetigo.

Detailed description:

Arms: arm 1: ozenoxacin cream 1% arm 2: Placebo cream
Interventions: intervention 1: Ozenoxacin intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02097056
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
Sponsor: Eisai Korea Inc.
Start date: 2014-02-01; Completion date: 2015-05-01
Enrollment: 171 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multi-center, open-label, single-arm, prospective, phase IV trial, evaluating safety and efficacy of donepezil hydrochloride in patients with moderate to severe Alzheimer's disease.

Detailed description:
This study consisted of pre-treatment and treatment phase. Pre-treatment phase was approximately 4 weeks including the screening and baseline process. In treatment phase, about 190 subjects received Donepezil HCl 23 mg once daily for 24 weeks.

Arms: arm 1: Donepezil HCl 23 mg once daily, just before bed, for 24 weeks
Interventions: intervention 1: Donepezil HCL
Intervention descriptions: intervention 1: Donepezil HCl 23 mg once daily, just before bed, for 24 weeks

Protocol documents:
Clinical trial NCT02106494
Conditions: Chemotherapy-induced Nausea and Vomiting
Keywords: Highly emetogenic chemotherapy (HEC) Chemotherapy-Induced Nausea and Vomiting (CINV)
Sponsor: Heron Therapeutics
Start date: 2014-03-01; Completion date: 2015-05-01
Enrollment: 942 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary study objective is to demonstrate the superiority of APF530 500 mg given subcutaneously (SC) compared with ondansetron 0.15 mg/kg given intravenously (IV) (up to a maximum of 16 mg) in the delayed-phase (\> 24-120 hours) complete response (CR) rate (defined as no emesis and no use of rescue medications) in subjects receiving highly emetogenic chemotherapy (HEC) as defined by the 2011 ASCO CINV guidelines

Detailed description:

Arms: arm 1: APF530 500 mg (granisetron 10 mg) SC and ondansetron placebo IV (0.15 mg/kg) and fosaprepitant 150 mg IV and dexamethasone 12 mg IV on Day 1 of Cycle 1 in association with HEC arm 2: Ondansetron 2 mg/mL solution to be administered at 0.15 mg/kg IV (up to a maximum of 16 mg) and APF530 placebo SC and fosaprepitant 150 mg IV and dexamethasone 12 mg IV on Day 1 of Cycle 1
Interventions: intervention 1: APF530 intervention 2: Ondansetron intervention 3: Ondansetron placebo intervention 4: APF530 placebo intervention 5: Fosaprepitant intervention 6: Dexamethasone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT02113241
Conditions: Metabolic Syndrome X
Keywords: metabolic syndrome forxiga dapagliflozin insulin secretion insulin sensitivity
Sponsor: University of Guadalajara
Start date: 2014-04-01; Completion date: 2015-05-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease.

Dapagliflozin is an inhibitor of the sodium-glucose co-transporter SGLT2 in the kidney and is a novel treatment for diabetes type 2. Some studies indicate that SGLT2 inhibitors have benefits on blood pressure, triglycerides levels and help to raise the levels of high density lipoproteins cholesterol (c-HDL).

The aim of this study is to evaluate the effect of dapagliflozin on metabolic syndrome, insulin sensitivity and insulin secretion.

The investigators hypothesis is that the administration of dapagliflozin modifies the metabolic syndrome, insulin sensitivity and insulin secretion.

Detailed description:
A randomized, double-blind, placebo-controlled clinical trial its going to carry out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, lipid profile, creatinine and acid uric are going to be load after a 75 g of dextrose load.

12 patients will receive Forxiga (dapagliflozin), 10 mg, one per day before breakfast during 3 months.

The remaining 12 patients will receive placebo at the same dose.

There will be calculated Area Under the Curve of glucose and insulin, total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).

This protocol it's already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.

Results will be presented as mean and standard deviation. Intra and inter group differences are going to be tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 it's going to be considered significant.

Arms: arm 1: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days. arm 2: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Interventions: intervention 1: Dapagliflozin intervention 2: Placebo
Intervention descriptions: intervention 1: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days. intervention 2: Placebo capsules, 10 mg, one per day before breakfast during 90 days.

Protocol documents:
Clinical trial NCT02120456
Conditions: Actinic Keratosis
Sponsor: LEO Pharma
Start date: 2014-05-01; Completion date: 2015-05-01
Enrollment: 224 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Part 1: To identify Maximum Tolerated Dose (MTD) levels of LEO 43204 after once daily treatment for two consecutive days

Part 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle

Detailed description:

Arms: arm 1: Open-label, dose-escalation, 2-day treatment arm 2: LEO 43204 dose 0.1% once daily for two consecutive days arm 3: LEO 43204 dose 0.075% once daily for two days arm 4: Placebo once daily for two days
Interventions: intervention 1: LEO 43204 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02121210
Conditions: Rheumatoid Arthritis
Sponsor: Sanofi
Start date: 2014-06-01; Completion date: 2015-05-01
Enrollment: 132 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

To evaluate the immunogenicity of sarilumab administered as monotherapy.

Secondary Objectives:

* To evaluate the other safety aspects of sarilumab administered as monotherapy.
* To assess the exposure of sarilumab administered as monotherapy.

Detailed description:
Total study duration was up to 34 weeks: Up to 4-week screening period, 24-week open-label treatment phase, 6-week post-treatment observation. After completion of the treatment phase of this study, participants were eligible to enter a long term safety study (LTS11210 - SARIL-RA-EXTEND) for continuous treatment with sarilumab (SAR153191 \[REGN88\]).

Arms: arm 1: Sarilumab 150 mg subcutaneous (SC) injection every two weeks (q2w) for 24 weeks. arm 2: Sarilumab 200 mg SC injection q2w for 24 weeks.
Interventions: intervention 1: sarilumab SAR153191 (REGN88)
Intervention descriptions: intervention 1: Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous

Protocol documents: