ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01055028
Conditions: Angiosarcomas Soft Tissue Sarcoma
Sponsor: Stanford University
Start date: 2010-02-01; Completion date: 2016-06-24
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, single-arm, multi-center, Phase 2 study with Paclitaxel in combination with Bevacizumab in patients with Unresectable or Metastatic Angiosarcoma. The study aims to determine the safety and effectiveness of combining two drugs Paclitaxel and Bevacizumab in the treatment of Angiosarcoma that cannot be removed by surgery, or has spread to other parts of your body. The primary objective is to evaluate 4month non progression rate. The secondary objective is to evaluate overall response rate after 3rd and 6th cycle, median duration of response, 6th and 12th month survival, toxicity of Paclitaxel and Bevacizumab combination, toxicity of maintenance Bevacizumab and to collect paraffin-embedded tumor blocks for angiogenesis markers and tissue microarray.

Detailed description:
Regimen A versus B was chosen at the discretion of the treating physician. Both groups were analyzed together as far as outcome.

Patients were to receive paclitaxel 200 mg/m2 intravenously over 3 hours every 21 days (Regimen A) or pactlitaxel 90 mg/m2 weekly x 3 of a 28 day cycle (Regimen B) followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3-6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB) started after the completion of combination of paclitaxel and bevacizumab and it was given at a dose of 15 mg/kg intravenously once every 21 days for a maximum of 8 cycles. Patients were allowed to receive growth factors. Dose reductions were done based on hematologic and non-hematologic toxicities.

Arms: arm 1: Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.

Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination. arm 2: Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.

Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.
Interventions: intervention 1: Bevacizumab intervention 2: Paclitaxel
Intervention descriptions: intervention 1: 15 mg/kg, IV every 21 days x 6 cycles. intervention 2: Regimen A / Treatment 1: 200 mg/m² IV over 3 hours every 21 days.

Regimen B / Treatment 2: 90 mg/m² weekly x 3 of a 28-day cycle

Protocol documents:
Clinical trial NCT01715805
Conditions: Major Depressive Disorder
Keywords: MDD Major Depressive Disorder
Sponsor: Forest Laboratories
Start date: 2012-11-15; Completion date: 2016-06-24
Enrollment: 1022 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD

Detailed description:

Arms: arm 1: Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks. arm 2: Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16). arm 3: Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16). arm 4: Following the 8 week ADT plus single blind placebo lead-in period, participants who were ADT responders continued treatment with ADT plus placebo for an additional 8 weeks.
Interventions: intervention 1: Cariprazine intervention 2: Placebo intervention 3: Antidepressant Therapy (ADT)
Intervention descriptions: intervention 1: Cariprazine capsules 1.5 to 4.5 mg/day intervention 2: Dose-matched placebo capsule once per day intervention 3: ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.

Protocol documents:
Clinical trial NCT01867047
Conditions: Adverse Effects of Angiotensin-converting-enzyme Inhibitors Hypotension
Sponsor: Duke University
Start date: 2013-06-01; Completion date: 2016-06-24
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effects of Angiotension Converting Enzyme Inhibitors (ACE-I) during surgery and in the immediate postoperative period for patients undergoing elective total hip or knee arthroplasty.

Detailed description:

Arms: arm 1: Subjects randomized to this group will continue their ACE-I through the day of surgery arm 2: Subjects randomized to this group will stop their ACE-I two days prior to surgery (last dose \>48 hours prior to surgery)
Interventions: intervention 1: ACE-I Cessation group intervention 2: ACE-I Continuation group
Intervention descriptions: intervention 1: Subjects stop ACE-I 48 hours prior to surgery. Examples of possible ACE-I drugs include:

benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), trandolapril (Mavik) intervention 2: Subjects take ACE-I through day of surgery. Examples of possible ACE-I drugs include:

benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), trandolapril (Mavik)

Protocol documents:
Clinical trial NCT02539654
Conditions: Otitis Media With Effusion in Children Otitis Media Recurrent
Sponsor: Alcon Research
Start date: 2015-11-17; Completion date: 2016-06-24
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects, immediately after bilateral tympanostomy tube surgery.

Detailed description:

Arms: arm 1: EXE844 Sterile Otic Suspension, 0.3%, single ototopical dose (4 drops) in each ear following tympanostomy tube insertion
Interventions: intervention 1: EXE844 Sterile Otic Suspension, 0.3% intervention 2: Tympanostomy Tube Insertion
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02634788
Conditions: Pain
Keywords: Post-Surgical Pain Bunionectomy
Sponsor: INSYS Therapeutics Inc
Start date: 2016-01-29; Completion date: 2016-06-24
Enrollment: 322 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this trial is to evaluate analgesic efficacy of Buprenorphine Sublingual (under the tongue) Spray compared with placebo in participants with postoperative pain after bunionectomy.

Detailed description:

Arms: arm 1: Participants received buprenorphine 0.5 mg sublingual (under the tongue) spray three times daily (TID) for two days. arm 2: Participants received buprenorphine 0.25 mg sublingual spray TID for two days. arm 3: Participants received buprenorphine 0.125 mg sublingual spray TID for two days. arm 4: Participants received placebo-matching buprenorphine sublingual spray TID for two days.
Interventions: intervention 1: Buprenorphine intervention 2: Placebo
Intervention descriptions: intervention 1: Buprenorphine sublingual spray delivered via single 100 μL spray intervention 2: Placebo-matching buprenorphine sublingual spray delivered via single 100 μL spray

Protocol documents:
Clinical trial NCT01351415
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2011-06-25; Completion date: 2016-06-25
Enrollment: 485 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label, randomized, multicenter study will evaluate the efficacy and safety of bevacizumab (Avastin) in combination with standard of care (SOC) treatment in participants with advanced non-squamous NSCLC. Participants will be enrolled at documentation of progression of disease (PD) after 4-6 cycles of first-line treatment with bevacizumab plus a platinum doublet-containing therapy and a minimum of two cycles of bevacizumab maintenance treatment prior to PD. Participants will be randomly assigned to one of two treatment arms to receive either bevacizumab plus SOC treatment or SOC treatment alone.

Detailed description:

Arms: arm 1: Participants will receive bevacizumab on Day 1 of every 21-days cycle along with standard of care (Erlotinib or Docetaxel or Pemetrexed) as second line treatment, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first). arm 2: Participants will receive investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
Interventions: intervention 1: Bevacizumab intervention 2: Docetaxel intervention 3: Erlotinib intervention 4: Pemetrexed
Intervention descriptions: intervention 1: Participants will receive bevacizumab 7.5 or 15 milligrams per kilogram (mg/kg) intravenously. intervention 2: Docetaxel 60 or 75 milligram per meter square (mg/m\^2) on Day 1 every 21 days. intervention 3: Erlotinib 150 mg daily taken on an empty stomach at least one hour before or two hours after the ingestion of food. intervention 4: Pemetrexed 500 mg/m\^2 IV over 10 minutes on Day 1 every 21 days.

Protocol documents:
Clinical trial NCT02233543
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD QVA149 nocturnal oxygen levels combination bronchodilator
Sponsor: Novartis Pharmaceuticals
Start date: 2014-11-30; Completion date: 2016-06-26
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study was to determine whether a fixed dose combination of indacaterol and glycopyrronium (QVA149) has an impact on night-time blood oxygen levels in Chronic Obstructive Pulmonary Disease.

Detailed description:

Arms: arm 1: Participants received 4 weeks of QVA149 85/43 μg delivered dose once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day followed by 2 weeks washout. Then participants received 4 weeks of placebo once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day. arm 2: Participants received 4 weeks of placebo once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day followed by 2 weeks washout. Then participants received 4 weeks of QVA149 85/43 μg delivered dose once daily in the morning between 08:00 and 11:00 AM at approximately the same time every day.
Interventions: intervention 1: QVA149 intervention 2: QVA149 Placebo
Intervention descriptions: intervention 1: Delivered once daily via single-dose dry powder inhaler intervention 2: Placebo delivered once daily via single-dose dry powder inhaler

Protocol documents:
Clinical trial NCT01491958
Conditions: Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Myelodysplastic Syndrome
Keywords: Leukemia AML ALL MDS
Sponsor: Ohio State University Comprehensive Cancer Center
Start date: 2011-12-10; Completion date: 2016-06-27
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Phase II trial evaluating the safety \& efficacy of Atorvastatin for prophylaxis of Acute Graft Versus Host Disease (GVHD) in patients with hematological malignances undergoing human leukocyte antigen (HLA)-Matched Related Donor Hematopoietic Stem Cell Transplant (HSCT).

Detailed description:
The study is a single-arm phase II single institutional trial evaluating the safety and efficacy of atorvastatin for the prophylaxis of acute GVHD in patients with hematological malignancies undergoing HLA matched related donor HSCT. This study will explore a two-pronged acute GVHD prophylaxis strategy, consisting of pre-treating consenting related donors with atorvastatin before stem cell mobilization and collection, followed by atorvastatin plus methotrexate/tacrolimus-based GVHD prophylaxis in transplant recipient patients.

Arms: arm 1: Related donors will receive atorvastatin 40 mg/day orally at least 14 days before anticipated first day of stem cell leukapheresis (LP) until successful completion of leukapheresis according to institutional guidelines. Peripheral blood stem cells will not be manipulated or T-depleted prior to administration. arm 2: Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.
Interventions: intervention 1: atorvastatin intervention 2: Tacrolimus intervention 3: methotrexate
Intervention descriptions: intervention 1: donors-will receive atorvastatin 40 mg/day orally at least 14 days before anticipated first day of stem cell leukapheresis (LP) until successful completion of leukapheresis according to institutional guidelines.

Patients-will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. intervention 2: beginning on Day -2 through approximately Day +180 (that is, approximately 6 months after Day 0) intervention 3: Day +1, +3, and +6 and +11

Protocol documents:
Clinical trial NCT02025725
Conditions: Diabetic Gastroparesis
Keywords: Gastroparesis Diabetic Delayed gastric emptying Gastric stasis Nausea Vomiting Bloating Abdominal pain Early satiety Gastropathy
Sponsor: Evoke Pharma
Start date: 2014-03-27; Completion date: 2016-06-27
Enrollment: 205 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is provide confirmation of the safety and efficacy of Metoclopramide Nasal Spray compared to placebo in reducing the symptoms of diabetic gastroparesis in adult women.

Detailed description:
Diabetic women with clinical symptoms attributed to diabetic gastroparesis and documentation of delayed gastric emptying who meet the protocol-specified entry criteria will be randomized to Metoclopramide Nasal Spray 10 mg or placebo administered as a single intranasal spray four (4) times daily; 30 minutes before meals and at bedtime for a total of four (4) weeks.

Arms: arm 1: Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks arm 2: Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks
Interventions: intervention 1: Metoclopramide Nasal Spray intervention 2: Placebo Nasal Spray
Intervention descriptions: intervention 1: nasal spray formulation of metoclopramide intervention 2: nasal spray formulation with vehicle only

Protocol documents:
Clinical trial NCT02732327
Conditions: Neoplasms Febrile Neutropenia
Sponsor: Forest Laboratories
Start date: 2016-05-17; Completion date: 2016-06-27
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effect, safety, and tolerability of ceftazidime-avibactam (CAZ-AVI) plus vancomycin or linezolid compared to standard of care plus vancomycin or linezolid as empiric therapy in febrile neutropenic adults with cancer

Detailed description:

Arms: arm 1: Ceftazidime-Avibactam (CAZ-AVI) 2.5 mg intravenous (IV) infusion every 8 hours for 5 to 14 days, duration determined by the investigator, plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local standard of care \[SOC\]) may be allowed after at least 72 hours (ie, minimum of 9 doses for CAZ-AVI) of inpatient IV study drug. arm 2: Standard of Care (cefepime 2 g IV infusion every 8 hours or meropenem 1 g IV infusion every 8 hours or piperacillin/tazobactam 4.5 g IV infusion every 6 hours for 5 to 14 days, duration determined by the investigator) plus vancomycin 15 mg/kg IV or linezolid 600 mg IV every 12 hours. A switch to open-label oral or IV therapy (IV therapy for outpatient or home administration per local SOC) may be allowed after at least 72 hours (ie, minimum of 9 doses for SOC therapies, except piperacillin/tazobactam, which is a minimum of 12 doses) of inpatient IV study drug.
Interventions: intervention 1: CAZ-AVI intervention 2: Vancomycin intervention 3: Linezolid intervention 4: Cefepime intervention 5: Meropenem intervention 6: Piperacillin/tazobactam
Intervention descriptions: intervention 1: Ceftazidime-Avibactam (2 g ceftazidime and 0.5 g avibactam) intervention 2: 15 mg/kg intervention 3: 600 mg intervention 4: 2 g intervention 5: 1 g intervention 6: 4.5 g

Protocol documents:
Clinical trial NCT02049814
Conditions: Type 2 Diabetes Mellitus
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2014-05-09; Completion date: 2016-06-28
Enrollment: 494 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the efficacy of voglibose versus acarbose combined with metformin in participants with type 2 diabetes mellitus (T2DM) by evaluating levels of glycosylated hemoglobin.

Detailed description:
The drug being tested in this study is called voglibose. Voglibose is being tested to treat type 2 diabetes in people who have diabetes that is inadequately controlled on metformin alone. This study will look at glycemic control in people who take voglibose.

The study will enroll 494 patients. All participants will be enrolled in a 2-week screening phase and a metformin run-in phase. Eligible participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:

* Metformin and Voglibose 0.2 mg
* Metformin and Acarbose 50 mg

All participants will be asked to take their current dose of metformin tablets and either voglibose or acarbose tablets three times a day throughout the study.

This multi-center trial will be conducted in China. The overall time to participate in this study is up to 20 weeks and participants will make 8 visits to the clinic.

Arms: arm 1: Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to voglibose 0.2 mg, tablets, orally, three times daily, for Weeks 1 and 2, followed by voglibose 0.3 mg, tablets, orally, three times daily, Weeks 3 through 12. arm 2: Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to acarbose 50 mg, tablets, orally, three times daily, Weeks 1 and 2, then acarbose 100 mg, tablets, orally, three times daily, Weeks 3 through 12.
Interventions: intervention 1: Metformin intervention 2: Voglibose intervention 3: Acarbose
Intervention descriptions: intervention 1: Metformin tablets intervention 2: Voglibose tablets intervention 3: Acarbose tablets

Protocol documents:
Clinical trial NCT02536313
Conditions: Hepatitis C Virus Infection
Sponsor: Gilead Sciences
Start date: 2015-07-29; Completion date: 2016-06-28
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection and prior treatment experience with a direct acting antiviral (DAA).

Detailed description:

Arms: arm 1: SOF/VEL/VOX for 12 weeks arm 2: SOF/VEL/VOX + RBV for 12 weeks
Interventions: intervention 1: SOF/VEL/VOX intervention 2: RBV
Intervention descriptions: intervention 1: 400/100/100 mg FDC tablet administered orally once daily with food intervention 2: Tablets 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 NCT00984126
Conditions: Congenital Bleeding Disorder Haemophilia A
Sponsor: Novo Nordisk A/S
Start date: 2009-10-26; Completion date: 2016-06-29
Enrollment: 214 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America.

The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in Haemophilia A patients.

The trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and NN7008-3545 (start: May 2010, stop: November 2011) and the pharmacokinetic trials NN7008-3600 (start: November 2010, stop: October 2011), NN7008-3893 (start: June 2011, stop: September 2011) and NN7008-4015 (start: August 2012, stop: March 2013).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: turoctocog alfa intervention 2: turoctocog alfa
Intervention descriptions: intervention 1: The preventative treatment is administered intravenously (i.v.) at specific intervals either every second day or three times a week. Bleeding treatment will be administered if a bleed should occur. intervention 2: Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)

Protocol documents:
Clinical trial NCT01737268
Conditions: Bipolar Disorder Elderly
Keywords: patients Major depressive episode FK949E
Sponsor: Astellas Pharma Inc
Start date: 2012-10-29; Completion date: 2016-06-29
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
FK949E was administered to elderly bipolar disorder patients with major depressive episode for 52 weeks. Its safety, efficacy, and plasma concentration change were evaluated in an open-label manner.

Detailed description:

Arms: arm 1: After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator's discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period.
Interventions: intervention 1: FK949E
Intervention descriptions: intervention 1: Oral tablet

Protocol documents: