ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01727141
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, QVA149
Sponsor: Novartis Pharmaceuticals
Start date: 2012-11-01; Completion date: 2014-02-01
Enrollment: 1042 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to severe airflow limitation.

Detailed description:
NOTE: Detailed Description: data not entered

Arms: arm 1: 27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI) arm 2: 27.5 ug b.i.d. arm 3: 12.5 ug b.i.d. arm 4: b.i.d
Interventions: intervention 1: QVA149 intervention 2: QAB149 intervention 3: NVA237 intervention 4: Placebo
Intervention descriptions: intervention 1: QVA149 was supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI intervention 2: QAB149 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI. intervention 3: NVA237 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI. intervention 4: Placebo was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.

Protocol documents:
Clinical trial NCT01729728
Conditions: Postoperative Pain Acute Pain
Keywords: Tonsillectomy Dental surgery Ear surgery Nose surgery Throat surgery
Sponsor: Grünenthal GmbH
Start date: 2012-11-01; Completion date: 2014-02-01
Enrollment: 86 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To find out if a drug called tapentadol administered by mouth safely relieves pain in children. Look at the amount of tapentadol in the blood after a single oral dose.

Tapentadol oral solution for children is still being tested and is not yet registered. Tapentadol tablets are effective in treating both acute and chronic pain in adults. This trial will help to understand how tapentadol oral solution works in children.

Detailed description:
The lower age limit for the clinical trial was initially set to 3 years of age in the protocol. The trial planned for the inclusion of participants in three age categories. Age 3 to less than 6 years (young children), age 6 to less than 12 years (older children) and age 12 to less than 18 years of age (adolescents). There was a request by the Paediatric Committee (PDCO) at the European Medicines Agency to include participants 2 years of age (very young children). The protocol amendment thus planned to combine the two youngest age groups into a single reporting group. The protocol amendment only planned that the very young children group would have separate analysis for the Faces Pain Scale Revised (FPS-R) Scale and for the presentation of the serum concentrations, because the pharmacokinetic sampling scheme used in the 2 year old participants was different from the young children group (aged 3 to less than 6 years).

Arms: arm 1: None
Interventions: intervention 1: Tapentadol
Intervention descriptions: intervention 1: Tapentadol oral solution single dose (1mg/kg body weight)

Protocol documents:
Clinical trial NCT01735175
Conditions: Neutropenic Complications Breast Neoplasms Chemotherapy-induced Neutropenia Chemotherapeutic Toxicity
Keywords: biosimilars Pegfilgrastim, G-CSF, neutropenia, breast cancer, myelosuppressive chemotherapy, supportive care granulocyte-colony-stimulating factor
Sponsor: Sandoz
Start date: 2012-06-01; Completion date: 2014-02-01
Enrollment: 316 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

Detailed description:
This randomized, double-blind trial compared the proposed biosimilar LA-EP2006 with the reference Neulasta® in women (≥18 years) receiving chemotherapy for breast cancer. Therefore patients were randomized to receive LA-EP2006 (n = 159) or the reference product (n = 157) for ≤6 cycles of (neo)-adjuvant TAC (docetaxel 75mg/m\^2, doxorubicin 50 mg/m\^2, and cyclophosphamide 500mg/m\^2) chemotherapy. The primary end point was the duration of severe neutropenia (DSN) during Cycle 1 (defined as number of consecutive days with absolute neutrophil count \<0.5 × 10\^9/l). The equivalence was confirmed if 95% CIs were within a ±1 day margin. LA-EP2006 was equivalent to the reference product in DSN (difference: 0.07 days; 95% CI \[-0.12, 0.26\]). Further, LA-EP2006 and the reference Neulasta® showed no clinically meaningful differences regarding efficacy and safety.

Arms: arm 1: During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application. arm 2: During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
Interventions: intervention 1: LA-EP2006 intervention 2: Neulasta®
Intervention descriptions: intervention 1: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application. intervention 2: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.

Protocol documents:
Clinical trial NCT01768286
Conditions: Chronic Hepatitis C Virus
Keywords: HCV genotype 1 (GT-1) HCV Sustained Virologic Response Direct Acting Antiviral Combination Therapy GS-7977 GS-5885 Ribavirin Open Label Sofosbuvir Additional relevant MeSH terms: Hepatitis Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action
Sponsor: Gilead Sciences
Start date: 2013-01-01; Completion date: 2014-02-01
Enrollment: 441 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1 hepatitis C virus (HCV) infection.

Detailed description:

Arms: arm 1: Participants will receive LDV/SOF FDC for 12 weeks. arm 2: Participants will receive LDV/SOF FDC plus RBV for 12 weeks. arm 3: Participants will receive LDV/SOF FDC for 24 weeks. arm 4: Participants will receive LDV/SOF FDC plus RBV for 24 weeks.
Interventions: intervention 1: LDV/SOF intervention 2: RBV
Intervention descriptions: intervention 1: Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet administered orally once daily intervention 2: Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents:
Clinical trial NCT01772537
Conditions: Thoracic Aneurysm Aneurysm Stent Cardiopulmonary Bypass Abdominal Aneurysm
Keywords: thoracoabdominal aneurysm open stent cardiopulmonary abdominal bypass
Sponsor: Johns Hopkins University
Start date: 2012-05-01; Completion date: 2014-02-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Alzheimer's disease represents a growing public health problem in developed countries. Although the pathogenesis is not clearly defined, accumulation of extracellular amyloid, neurofibrillary tangles and neuronal loss are the hallmarks of Alzheimer's disease. The effect of anesthetic agents on changes in these proteins in humans is not well characterized, but in-vitro evidence suggests that anesthetic agents can accelerate potential pathogenic mechanisms, such as increasing amyloid formation or rates of apoptosis in cultured cells and increasing amyloid levels in mice. Human data on the effect of anesthetic agents on amyloid and tau proteins is limited to a small series of 11 patients and showed a significant increase in tau levels after exposure to anesthetics. In this study the investigators propose to measure CSF and serum biomarkers in a population of patients with normal CSF dynamics, who are undergoing surgery for repair of a thoracoabdominal aneurysm. The investigators will also obtain preliminary data on whether changes in CSF levels of these proteins are associated with postoperative delirium or cognitive change.

Detailed description:

Arms: arm 1: These will be patients undergoing an open repair of thoracoabdominal aneurysms with or without cardiopulmonary bypass. The will be observational only. arm 2: These patients are patients receiving repair of thoracoabdominal aneurysms using stent grafts. These patients will be randomized to receive isoflurane as their primary anesthetic. arm 3: These patients are patients receiving repair of thoracoabdominal aneurysms using stent grafts. These patients will be randomized to receive propofol as their primary anesthetic.
Interventions: intervention 1: Propofol intervention 2: isoflurane
Intervention descriptions: intervention 1: Intravenous anesthetic intervention 2: None

Protocol documents:
Clinical trial NCT01811485
Conditions: Diabetes Mellitus, Type 2
Sponsor: Novartis Pharmaceuticals
Start date: 2013-05-01; Completion date: 2014-02-01
Enrollment: 171 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study was to evaluate the efficacy and safety of LMF237 50/250 mg and 50/500 mg bid in Japanese patients with T2DM inadequately controlled with vildagliptin monotherapy. This study was conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of T2DM in Japan.

Detailed description:

Arms: arm 1: Patients took LMF237 50/250 mg twice daily for 14 weeks arm 2: Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks arm 3: Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
Interventions: intervention 1: LMF237 50/250 mg intervention 2: LMF237 50/500 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Corresponds to vildagliptin 50 mg twice daily and metformin 250 mg twice daily intervention 2: Corresponds to vildagliptin 50 mg twice daily and metformin 500 mg twice daily intervention 3: Matching placebo of LMF237 (contained vildagliptin 50 mg as active ingredient) twice daily

Protocol documents:
Clinical trial NCT01817777
Conditions: Diabetes Mellitus, Type 2
Keywords: Socioeconomic category Medication compliance Metformin small pack
Sponsor: GlaxoSmithKline
Start date: 2013-05-01; Completion date: 2014-02-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
MTF116086 is an open-label, randomised, parallel-design study in subjects with type II diabetes. The study is site-based, with local pharmacies serving as the sites and pharmacists as principal investigators for the sites. All subjects will enter an initial 8-week observational phase during which purchase behaviour and compliance with usual metformin use will be observed and recorded. At the end of the observational phase, subjects will be randomised to one of the two arms (metformin small pack vs. metformin large pack) for a 20-week interventional phase. The medication in the interventional phase is provided to the subjects free of charge. HbA1c will be collected for all subjects during Week 0, Week 8, and Week 28. Subjects will be asked questions about their tablet compliance, their satisfaction with the pack size they received and reasons for missing doses throughout the interventional phase by the pharmacist. The pharmacy visit on Week 28 will be end of the study.

Detailed description:

Arms: arm 1: All subjects in the study will be initially followed for an 8-week observational phase during which subjects will visit the pharmacy and purchase metformin following their usual routines. After 8-weeks subjects will be randomised to one of the 2 treatments arms. Subjects in the metformin small pack arm will receive medication free of charge in a small pack. Dosing of metformin will not be dictated by the protocol. Subjects will remain on their prescribed dose of metformin throughout the study, unless a change is recommended by their physician. arm 2: All subjects in the study will be initially followed for an 8-week observational phase during which subjects will visit the pharmacy and purchase metformin following their usual routines. After 8-weeks subjects will be randomised to one of the 2 treatments arms. Subjects in the metformin large pack arm will receive medication free of charge in a large, monthly pack. Dosing of metformin will not be dictated by the protocol. Subjects will remain on their prescribed dose of metformin throughout the study, unless a change is recommended by their physician.
Interventions: intervention 1: Metformin Small Pack intervention 2: Metformin Large Pack
Intervention descriptions: intervention 1: A single small pack of metformin will consist of a blister package containing 10 pills with a patient information leaflet in local language. The small packs will be available at each site in the following doses: 500 mg, 850 mg, and 1000 mg. The small pack size of metformin is not yet marketed. Small pack metformin will be provided by GSK as GSK brand metformin. intervention 2: The large pack will consist of 1 month's supply of metformin.

Protocol documents:
Clinical trial NCT01829477
Conditions: Diabetes Mellitus, Type 2
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2013-04-01; Completion date: 2014-02-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of TAK-875 compared to placebo on glycemic control over a 24-week Treatment Period when used as an add-on to glimepiride in addition to diet and exercise.

Detailed description:
The drug being tested in this study is called TAK-875. TAK-875 is being tested to treat people who have diabetes. This study will look at glycosylated hemoglobin (blood glucose combined with hemoglobin, also known as HbA1c) and blood sugar levels in people who take TAK-875 in addition to glimepiride and diet and exercise.

The study will enroll approximately 260 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* TAK-875 50 mg
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.

All participants will be asked to take one tablet at the same time each day throughout the study. This multi-center trial will be conducted in North America and Europe. The overall time to participate in this study is up to 44 weeks and participants will make up to 17 visits to the clinic.

Due to potential concerns about liver safety, on balance, the benefits of treating patients with fasiglifam (TAK-875) do not outweigh the potential risks.

For this reason, Takeda has decided voluntarily to terminate the development activities for fasiglifam.

Arms: arm 1: TAK-875 50 mg tablet, orally, once daily and glimepiride 6 mg (or Maximum Tolerated Dose), tablets, orally, once daily for up to 24 weeks. arm 2: TAK-875 placebo-matching tablet, orally, once daily and glimepiride 6 mg (or Maximum Tolerated Dose), tablets, orally, once daily for up to 24 weeks.
Interventions: intervention 1: TAK-875 intervention 2: TAK-875 Placebo intervention 3: Glimepiride
Intervention descriptions: intervention 1: TAK-875 50 mg tablets intervention 2: TAK-875 placebo-matching tablets intervention 3: Glimepiride tablet.

Protocol documents:
Clinical trial NCT01848041
Conditions: Blepharoptosis
Keywords: Blepharoptosis Ptosis
Sponsor: RVL Pharmaceuticals, Inc.
Start date: 2013-05-01; Completion date: 2014-02-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an exploratory, proof of concept study to evaluate the safety and efficacy of RVL-1201 dosed once or twice daily for 14 days compared to a placebo (vehicle) control in patients with ptosis.

Detailed description:
This is an exploratory, proof-of-concept study. The objectives include establishing the efficacy and duration of effect of once daily (QD) or twice daily (BID) administration of RVL-1201 and the safety profile following 14 days of treatment in 72 subjects (24 per arm) with acquired blepharoptosis.

Efficacy will be assessed at each treatment visit by the Humphrey Visual Field 36-point ptosis protocol test, photographic measurement of marginal reflex distance, palpebral fissure distance and contrast sensitivity in the study eye only and Visual Acuity assessment in both eyes.

Safety assessments will include slit lamp examination/corneal fluorescein staining, pupil size measurement, ophthalmoscopy/ fundus examination, tonometry, visual acuity; urine pregnancy test (for women of childbearing potential only), vital signs (Heart Rate/Blood Pressure); and collection of adverse events. Subject rating of study medication comfort and assessment of ongoing tolerability will also be obtained.

Primary efficacy endpoint is the mean increase from baseline in points seen on the HVF 36-point ptosis protocol test at various timepoints according to a hierarchical analysis.

Analysis of exploratory endpoints will provide characterization of the efficacy and duration of effect of RVL-1201 with a variety of efficacy measures, as well as the potential additional effect of BID over QD dosing and safety profile of BID administration of RVL-1201. Exploratory endpoints will be analyzed by each regimen against placebo and between regimens and will include:

* The change from baseline in HVF, MRD, PFD, VA, and CS.
* The change from baseline in BP/HR

Arms: arm 1: RVL-1201 0.1% ophthalmic solution dosed one full drop per eye in the morning; one full drop of vehicle (placebo) per eye approximately 8 hours after the morning dose arm 2: RVL-1201 0.1% ophthalmic solution dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose arm 3: RVL 1201 ophthalmic solution vehicle (placebo) dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose
Interventions: intervention 1: RVL-1201 intervention 2: RVL-1201 Vehicle Placebo
Intervention descriptions: intervention 1: RVL-1201 0.1% Ophthalmic Solution intervention 2: RVL-1201 Vehicle Placebo

Protocol documents:
Clinical trial NCT01857531
Conditions: Smoking Cessation
Keywords: Smoking Cessation Quit Smoking Ganaxolone Nicotine Patch
Sponsor: Jed E. Rose
Start date: 2013-06-01; Completion date: 2014-02-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to evaluate whether the investigational drug ganaxolone can help smokers quit smoking. Ganaxolone is a drug that has been investigated (in other research studies) for the treatment of seizures and migraines. This drug is considered investigational in the US.

Detailed description:
The purpose of this proof-of-concept study is to evaluate whether expired air carbon monoxide (CO) will be reduced and smoking cessation success rates enhanced for smokers who receive the neurosteroid analog ganaxolone. The trial will be seeking preliminary indications of efficacy and tolerability in the smoking population and allow us to estimate effect sizes for future controlled trials.

Arms: arm 1: Pre-Quit Period:

Ganaxolone -- 400mg daily for the first 3 days, 800mg daily for the next 3 days and 1200mg daily for the remainder of the first 2 wks.

Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.

Post-Quit Period:

Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.

Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk.
Interventions: intervention 1: Ganaxolone intervention 2: Nicotine Patch
Intervention descriptions: intervention 1: Pre-Quit Period:

Beginning at Session P1, subjects will receive ganaxolone at a dose of 400mg total daily (200mg bid) for the first three days, 800mg total daily (400mg bid) for the next three days and 1200mg total daily (600mg bid) for the remainder of the first four weeks.

Post-Quit Period:

Following the quit-day, subjects will receive ganaxolone at a dose of (1200mg total daily) for the next week. Down-titration of ganaxolone will begin at post-quit week two. Subjects will receive ganaxolone at a dose of 800mg total daily (400mg bid) to take for three days and 400mg total daily (200mg bid) to take for three. intervention 2: Pre-Quit Period:

Beginning at Session P2, subjects will receive active 21mg/24h nicotine patches to apply daily for the next two weeks.

Post-Quit Period:

Following the quit-day, subjects will continue to apply active nicotine patches daily for the remainder of the study (21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week).

Protocol documents:
Clinical trial NCT01876381
Conditions: Chronic Renal Failure
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2013-06-01; Completion date: 2014-02-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To investigate the safety, pharmacokinetics, pharmacodynamics, and efficacy of OPC-41061 in patients with chronic renal failure undergoing hemodialysis or hemodiafiltration using variables, such as daily urine volume and increase in interval body weights between hemodialysis or hemodiafiltration, in 4-day intermittant administration (excluding the days of hemodialysis or hemodiafiltration) at the dose fixed during the dose-escalation period

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: OPC-41061
Intervention descriptions: intervention 1: The maximum number of days of administration will be 8 days (8 doses) in total 4 days each in the dose-escalation period and intermittant administration period. The investigational medicinal product (IMP) will be administered once daily after breakfast

Protocol documents: