ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00511901
Conditions: Anemia
Keywords: anemia function rehabilitation
Sponsor: University of Medicine and Dentistry of New Jersey
Start date: 2005-11-01; Completion date: 2008-05-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients who are admitted to subacute rehabilitation facilities following hospitalization are frequently anemic. The purpose of this study is to see if anemic patients treated with epoetin alfa will have higher hemoglobin levels and better functional recovery at 3, 8, and 12 weeks after study entry compared to patients who do not receive epoetin alfa.

Detailed description:
Anemia is associated with loss of function in some studies. However, it is unknown if more rapid correction of anemia in patients who enter a rehabilitation setting after surgery or from hospitalization for acute medical problems leads to shorter rehabilitation stays and improved functional status.

Patients aged 60 and older who have hemoglobin levels of less than 10.5 g/dL will be randomized to receive 8 weekly doses of either erythropoietin alfa or placebo. Functional status will be measured at baseline and then at 3, 8 and 12 weeks.

The following specific aims will be tested in this study:

* Determine the prevalence of anemia in patients admitted to a subacute rehabilitation facility with potential for recovery.
* Determine the baseline functional status of patients admitted to a subacute rehabilitation facility with potential for recovery using the Functional Independence Measure (FIM), an assessment tool used in acute rehabilitation settings.
* Determine if administration of epoetin alfa will result in higher hemoglobin concentrations in patients receiving the drug than in patients given placebo at 3, 8 and 12 weeks after entry into the study.
* Perform a study that establishes the feasibility of a trial to test whether epoetin alfa produces improvements in the FIM, grip strength, the time it takes for patients to reach rehabilitation goals, activity monitor, fatigue, mood, functional recovery and reduces length of rehabilitation stay.

Arms: arm 1: Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks arm 2: 40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
Interventions: intervention 1: placebo intervention 2: epoetin alpha intervention 3: Niferex
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00518115
Conditions: Diabetes Mellitus, Type 2
Keywords: GLP-1, Type 2 Diabetes, pharmacokinetics, pharmacodynamics, GSK716155, metformin, exenatide Type 2 Diabetes Mellitus
Sponsor: GlaxoSmithKline
Start date: 2007-04-01; Completion date: 2008-05-01
Enrollment: 361 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus who are either taking no diabetes medication or who are taking metformin only. This study will investigate the safety, tolerability, and efficacy of Albiglutide (GSK716155) and will measure the levels of Albiglutide (GSK716155) in the bloodstream when it is given for 16 weeks. As a comparison, some subjects will receive exenatide instead of Albiglutide (GSK716155). The study will involve weekly visits for 17 weeks,and less frequent follow-up visits for an additional 10 weeks. Assessments include repeat blood sampling and monitoring of any side effects.

Detailed description:
A 16-week, parallel-group, double-blind, randomized, placebo-controlled, multicenter, dose-ranging study to evaluate the efficacy, safety and tolerability of multiple doses and multiple treatment regimens of Albiglutide (GSK716155) with Byetta as an open-label active reference, in subjects with Type 2 Diabetes Mellitus.

Interventions: intervention 1: Albiglutide (GSK716155) or exenatide
Intervention descriptions: intervention 1: Albiglutide weekly subcutaneous injection or exenatide twice daily injection

Protocol documents:
Clinical trial NCT00522925
Conditions: Hypertension
Keywords: hypertension high blood pressure
Sponsor: Ligand Pharmaceuticals
Start date: 2007-08-01; Completion date: 2008-05-01
Enrollment: 280 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to see if PS433540 lowers blood pressure better than placebo and to see how safe PS433540 is compared to placebo.

Detailed description:

Arms: arm 1: Matching Placebo arm 2: None arm 3: None
Interventions: intervention 1: PS433540 intervention 2: placebo intervention 3: PS433540
Intervention descriptions: intervention 1: 200mg capsule, once daily for 28 days intervention 2: placebo capsule, once daily for 28 days intervention 3: 500mg capsule, once daily for 28 days

Protocol documents:
Clinical trial NCT00530920
Conditions: HIV Infections
Sponsor: Boehringer Ingelheim
Start date: 2007-10-01; Completion date: 2008-05-01
Enrollment: 85 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to identify an optimal dose combination(s) of tipranavir (TPV) and ritonavir (RTV) for antiretroviral treatment naïve HIV-1 infected patients that can be used in pivotal trial by assessing the steady-state pharmacokinetics and short-term efficacy and safety

Detailed description:

Interventions: intervention 1: tipranavir intervention 2: ritonavir
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00538304
Conditions: Glaucoma Ocular Hypertension
Sponsor: Allergan
Start date: 2007-11-01; Completion date: 2008-05-01
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A one month study which will determine the safety and efficacy of bimatoprost eye drops in patients with glaucoma or ocular hypertension

Detailed description:

Arms: arm 1: bimatoprost eye drops arm 2: placebo
Interventions: intervention 1: bimatoprost eye drops intervention 2: placebo
Intervention descriptions: intervention 1: 1 drop in each eye daily for 1 month intervention 2: 1 drop in each eye daily for 1 month

Protocol documents:
Clinical trial NCT00545168
Conditions: Pediculus Capitis Infestation
Keywords: head lice
Sponsor: ParaPRO LLC
Start date: 2007-09-01; Completion date: 2008-05-01
Enrollment: 480 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse, under actual use conditions in subjects 6 months of age or greater who are infested with Pediculosis capitis (Head lice).

Detailed description:
This is a Phase 3 multi-site, randomized, evaluator/investigator-blinded, three-arm, parallel group study evaluating the safety and efficacy of NatrOVA Creme Rinse - 1% (with nit combing and without nit combing) versus NIX Creme Rinse in an "actual use" environment.

Arms: arm 1: NatrOVA Creme Rinse (spinosad) 1% - no nit combing required arm 2: NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required arm 3: Nix Creme Rinse (permethrin 1%) applied according to OTC Instructions for Use
Interventions: intervention 1: Spinosad intervention 2: Spinosad intervention 3: Permethrin 1%
Intervention descriptions: intervention 1: 10 minute topical application of product, followed by a complete rinse off. intervention 2: 10 minute topical application followed by a complete rinse off, followed by a nit combing regimen. intervention 3: Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen

Protocol documents:
Clinical trial NCT00545753
Conditions: Pediculosis
Keywords: Human Head lice
Sponsor: ParaPRO LLC
Start date: 2007-09-01; Completion date: 2008-05-01
Enrollment: 558 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse, under actual use conditions in subjects 6 months of age or greater who are infested with Pediculosis capitis (human head lice).

Detailed description:
This is a Phase 3 multi-site, randomized, evaluator/investigator-blinded, three-arm, parallel group study evaluating the safety and efficacy of NatrOVA Creme Rinse - 1% (with nit combing and without nit combing) versus NIX Creme Rinse in an "actual use" environment.

Arms: arm 1: NatrOVA Creme Rinse (spinosad) 1% - no nit combing required arm 2: NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required arm 3: NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
Interventions: intervention 1: Spinosad intervention 2: Spinosad intervention 3: Permethrin 1%
Intervention descriptions: intervention 1: 10 minute topical application product, following by a complete rinse off. intervention 2: 10 minute topical application followed by a complete rinse off, followed by a nit combing regimen intervention 3: Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen

Protocol documents:
Clinical trial NCT00546715
Conditions: Chronic Hepatitis C
Sponsor: Bristol-Myers Squibb
Start date: 2007-11-01; Completion date: 2008-05-01
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of daclatasvir in subjects with chronic hepatitis C infection

Detailed description:

Arms: arm 1: Daclatasvir - 1 mg

Placebo - 0 mg arm 2: Daclatasvir - 10 mg

Placebo - 0 mg arm 3: Daclatasvir - 100 mg

Placebo - 0 mg arm 4: Daclatasvir - 0.5 - 200 mg (to be determined)

Placebo - 0 mg
Interventions: intervention 1: Daclatasvir intervention 2: Placebo
Intervention descriptions: intervention 1: Oral Solution, Oral, Single Dose intervention 2: Oral Solution, Oral, Single Dose

Protocol documents:
Clinical trial NCT00557466
Conditions: COPD
Keywords: QMF indacaterol TWISTHALER® device
Sponsor: Novartis
Start date: 2007-10-01; Completion date: 2008-05-01
Enrollment: 568 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.

Detailed description:

Arms: arm 1: Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 2: Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 3: Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 4: Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 5: Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. arm 6: Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
Interventions: intervention 1: indacaterol intervention 2: formoterol intervention 3: placebo to indacaterol intervention 4: placebo to formoterol intervention 5: short acting β2- agonist
Intervention descriptions: intervention 1: Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device). intervention 2: Formoterol delivered by oral inhalation via AEROLIZER® inhalation device. intervention 3: Placebo TWISTHALER® device intervention 4: Placebo AEROLIZER® device intervention 5: 100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

Protocol documents:
Clinical trial NCT00558025
Conditions: Parkinson Disease
Sponsor: Boehringer Ingelheim
Start date: 2007-10-01; Completion date: 2008-05-01
Enrollment: 156 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this trial conducted in early Parkinson's disease (PD) patients are:

* To assess if patients with early Parkinson's disease (PD) can be successfully switched (overnight switching) from Pramipexole (PPX) Immediate Release (IR) to Pramipexole Extended Release (ER). A successful switch at a specific visit is defined as no worsening of the Unified Parkinsons Disease Rating Scale (UPDRS) parts II+III score by more than 15% from baseline and no drug-related adverse events leading to withdrawal;
* To establish if this successful switch can be obtained with or without dose-adaptation;
* To provide information about the conversion ratio (mg:mg) from Pramipexole IR to Pramipexole ER.

Detailed description:

Arms: arm 1: Pramipexole Extended Release (ER) once daily arm 2: Pramipexole Immediate Release (IR) once daily
Interventions: intervention 1: Pramipexole Extended Release intervention 2: Pramipexole Immediate Release
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00558636
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: NSCLC
Sponsor: Bayer
Start date: 2007-09-01; Completion date: 2008-05-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study conducted in Asia-Pacific was to evaluate the efficacy and safety of Sorafenib in combination with paclitaxel and carboplatin versus placebo in combination with paclitaxel and carboplatin for chemonaive patients with unresectable stage IIIB (with effusion) or stage IV NSCLC. However, as indicated below, the study was terminated prematurely when the results from Study 11961 (NCT00300885), an earlier Phase 3 study of similar design in subjects with advanced NSCLC, showed an overall lack of efficacy and increased mortality in subjects with squamous subtype. The data available is presented as descriptive analyses, due to the limitations of implementing the statistical analysis plan.

Detailed description:
The study was terminated early when the results from Study 11961 (NCT00300885), an earlier Phase 3 study evaluating the effects of Sorafenib in combination with paclitaxel and carboplatin in subjects with advanced NSCLC, showed an overall lack of efficacy of Sorafenib in combination with paclitaxel and carboplatin in NSCLC and increased mortality in subjects with squamous subtype.

Arms: arm 1: Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), \[400 mg, (2 tablets x 200 mg each) orally, twice daily\] on Study Days 2-19 and paclitaxel (175 mg/m\^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days. arm 2: Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m\^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
Interventions: intervention 1: Sorafenib + Paclitaxel + Carboplatin intervention 2: Placebo + Paclitaxel + Carboplatin
Intervention descriptions: intervention 1: Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), \[400 mg, (2 tablets x 200 mg each) orally, twice daily\] on Study Days 2-19 and paclitaxel (175 mg/m\^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days. intervention 2: Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m\^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days

Protocol documents:
Clinical trial NCT00573261
Conditions: Diabetic Neuropathy
Keywords: Diabetic neuropathy Pregabalin Lyrica
Sponsor: Duke University
Start date: 2006-03-01; Completion date: 2008-05-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to examine how pregabalin affects parameters of autonomic nerve regulation in correlation with change in pain, anxiety, and depressive symptoms in patients with diabetic neuropathy.

Detailed description:
This study is designed to primarily examine how pregabalin affects the autonomic nerve or sympathetic-parasympathetic regulation in patients with diabetic neuropathy and its relationship to neuropathic pain. The goals of this study include (1) assessing the change of parameters of autonomic nerve function such as heart rate variability (HRV), respiratory sinus arrhythmia (RSA), minute ventilation, and changes in objective sleep parameters measured by means of the LifeShirt, upon treatment of pregabalin in comparison to placebo; (2) assessing the symptom change of neuropathic pain upon treatment of pregabalin in comparison to placebo; (3) assessing the change of anxiety symptoms upon treatment of pregabalin in comparison to placebo; (4) assessing the change of depressive symptoms upon treatment of pregabalin in comparison to placebo; (5) assessing the relationship of autonomic nerve function with neuropathic pain at baseline prior to treatment and the correspondences to the study drug; (6) assessing the relationship of autonomic nerve function with anxiety and depressive symptoms at baseline prior to treatment and their correspondences to the study drug; (7) identifying sensitive and reliable parameters of autonomic nerve regulation as predictor(s) of the severity and improvement of neuropathic pain and/or anxiety; and (8) to assess the change in objective sleep parameters (EEG/EOG) by means of the LifeShirt, upon treatment of pregabalin in comparison to placebo

Arms: arm 1: Pregabalin medication arm 2: Placebo
Interventions: intervention 1: Pregabalin intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day. intervention 2: Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.

Protocol documents:
Clinical trial NCT00583466
Conditions: Large Polyps in the Gastrointestinal Tract
Keywords: submucosal cushion polypectomy endoscopic mucosal resection
Sponsor: Johns Hopkins University
Start date: 2007-05-01; Completion date: 2008-05-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal tract wall. Various solutions are currently used, but some of them are easy to inject but quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive and not always available. The investigators performed previously animal experiments which demonstrated that blood is easy to inject and creates a protective cushion which lasts longer than other fluids which are currently used for protective cushion creation.

Detailed description:
For removal of large flat lesions of the gastro-intestinal tract injection of a solution under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal tract wall. Various solutions are currently used, but some of them are easy to inject but quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive and not always available. The investigators decided to use blood drawn from the patient for injection under the lesion. The investigators performed previously animal experiments which demonstrated that blood is easy to inject and creates a protective cushion which lasts longer than other fluids which are currently used for protective cushion creation. Blood can also have local hemostatic action preventing from bleeding during polypectomy.

Arms: arm 1: Polypectomy with normal saline injected for submucosal cushion creation arm 2: Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion arm 3: Polypectomy after injection of autologous blood
Interventions: intervention 1: Autologous blood injection intervention 2: Normal saline intervention 3: HPMC
Intervention descriptions: intervention 1: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion intervention 2: Normal saline will be injected under the lesion to create submucosal cushion intervention 3: Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion

Protocol documents:
Clinical trial NCT00586105
Conditions: Carcinoma, Renal Cell
Keywords: Sorafenib Nexavar Metastatic RCC Renal Cell Carcinoma Unresectable RCC
Sponsor: Bayer
Start date: 2005-12-01; Completion date: 2008-05-01
Enrollment: 39 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A multicenter uncontrolled study of sorafenib in patients with unresectable and/or metastatic renal cell carcinoma (RCC) to assess the pharmacokinetic profile, safety and tolerability, and efficacy.

Detailed description:

Arms: arm 1: 400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006)
Intervention descriptions: intervention 1: 400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)

Protocol documents:
Clinical trial NCT00586625
Conditions: Allergic Conjunctivitis
Sponsor: Bausch & Lomb Incorporated
Start date: 2007-10-01; Completion date: 2008-05-01
Enrollment: 861 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Safety study for bepotastine besilate ophthalmic solution in normal volunteers

Detailed description:

Arms: arm 1: bepotastine besilate ophthalmic solution 1.5% arm 2: vehicle
Interventions: intervention 1: Bepreve intervention 2: Placebo
Intervention descriptions: intervention 1: One drop, both eyes, twice a day intervention 2: One drop, both eyes, twice a day

Protocol documents: