ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01435655
Conditions: Transthyretin Familial Amyloid Polyneuropathy
Sponsor: Pfizer
Start date: 2011-11-01; Completion date: 2014-02-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Tafamidis has been developed as an oral specific stabilizer of transthyretin tetramer.

Detailed description:

Arms: arm 1: tafamidis
Interventions: intervention 1: tafamidis
Intervention descriptions: intervention 1: tafamidis meglumine 20 mg QD

Protocol documents:
Clinical trial NCT01438177
Conditions: Multiple Myeloma
Keywords: myeloma multiple myeloma relapsed myeloma refractory myeloma
Sponsor: NYU Langone Health
Start date: 2011-10-01; Completion date: 2014-02-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot phase II trial studies how well giving bortezomib and cyclophosphamide together with chloroquine works in treating patients with relapsed or refractory multiple myeloma.

Detailed description:
Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chloroquine may help chemotherapy drugs work better by making cancer cells more sensitive to the drug. Giving bortezomib and cyclophosphamide together with chloroquine may kill more cancer cells.

Arms: arm 1: VELCADE given by intravenous push at 1.3 mg/m\^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.

Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.

Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.

Each cycle is 42 days in length.
Interventions: intervention 1: Velcade intervention 2: Cyclophosphamide intervention 3: Chloroquine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01451814
Conditions: Smoking
Keywords: smoking cessation
Sponsor: Brown University
Start date: 2011-10-01; Completion date: 2014-02-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to test a manualized adaptation of positive psychotherapy (PPT) for smoking cessation (PPT-S). The investigators will conduct a preliminary randomized clinical trial (N = 80) to examine the feasibility, acceptability, and efficacy of PPT-S over 26 weeks of follow up in comparison to a standard smoking cessation treatment. Both treatments will be delivered in individual 6 sessions over 6 weeks, and will include provision of transdermal nicotine patch. The effect size estimates from this Stage 1b research will provide the foundation for a future application to conduct a large-scale, Stage II, randomized clinical trial.

Detailed description:

Arms: arm 1: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch. arm 2: 6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition
Interventions: intervention 1: Positive Psychotherapy for smoking cessation intervention 2: Nicotine polacrilex intervention 3: Relaxation training intervention 4: Behavioral smoking cessation treatment
Intervention descriptions: intervention 1: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch. intervention 2: 8 weeks of nicotine patch intervention 3: Instructions in progressive muscle relaxation intervention 4: Counseling on techniques to manage triggers and avoid smoking

Protocol documents:
Clinical trial NCT01453946
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Sponsor: Padagis LLC
Start date: 2011-12-01; Completion date: 2014-02-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A Safety for Maintenance of Entocort EC for children with mild to moderate Crohn's Disease.

Detailed description:
A Multicenter, Open label, Non-comparative Study to Evaluate the Safety of Entocort EC as a Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

Arms: arm 1: Study Medication
Interventions: intervention 1: Entocort
Intervention descriptions: intervention 1: Entocort capsules, taken orally, 6 mg daily.

Protocol documents:
Clinical trial NCT01467479
Conditions: Hepatitis C
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2011-12-01; Completion date: 2014-02-01
Enrollment: 185 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to treat human immunodeficiency virus (HIV) and Hepatitis C Virus (HCV) co-infected subjects with telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) to achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA) 12 weeks after the last planned dose of study drug.

Detailed description:

Arms: arm 1: Participants who were receiving atazanavir/ritonavir (ATV/r) based highly active antiretroviral therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion. arm 2: Participants who were receiving efavirenz (EFV) based highly active antiretroviral therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet three times a day for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion. arm 3: Participants who were receiving raltegravir (RAL) based highly active antiretroviral therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Interventions: intervention 1: Telaprevir intervention 2: Ribavirin intervention 3: Pegylated Interferon Alfa-2a intervention 4: Highly Active Antiretroviral Therapy (HAART)
Intervention descriptions: intervention 1: Tablet intervention 2: Tablet intervention 3: Subcutaneous Injection intervention 4: Atazanavir/ritonavir (ATV/r) based HAART, Efavirenz (EFV) based HAART, or Raltegravir (RAL) based HAART, as per standard practice. HAART medications were not considered study drugs.

Protocol documents:
Clinical trial NCT01471691
Conditions: Branch Retinal Vein Occlusion Central Retinal Vein Occlusion Macular Edema
Sponsor: Hanscom, Thomas, M.D.
Start date: 2011-11-01; Completion date: 2014-02-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study examines two doses of Ranibizumab (0.5mg and 1.0mg) for the treatment of macular edema secondary to retinal vein occlusion in patients that have previously failed treatment with other macular edema treatments including bevacizumab.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ranibizumab 0.5mg intervention 2: ranibizumab 1.0mg
Intervention descriptions: intervention 1: Standard dose intervention 2: High dose

Protocol documents:
Clinical trial NCT01474122
Conditions: Digital Ulcers
Keywords: digital ulcers systemic sclerosis
Sponsor: Actelion
Start date: 2011-12-01; Completion date: 2014-02-01
Enrollment: 265 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The DUAL-2 study is designed as a multicenter, double-blind two-period study with an initial fixed 16-week Period 1, followed by a Period 2 of variable duration. All patients completing Period 1 continue on their original randomized treatment into Period 2, until the last randomized patient has completed Period 1.

Patients are randomized in a 1:1:1 ratio (macitentan 3mg: macitentan 10mg: placebo).

The primary objective is to demonstrate the effect of macitentan on the reduction of the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcers (DU).

Other objectives include:

* the evaluation of the efficacy of macitentan on hand functionality and DU burden at Week 16 in SSc patients with ongoing DU disease.
* the evaluation of the safety and tolerability of macitentan in these patients.
* the evaluation of the efficacy of macitentan on time to first DU complication during the entire treatment period.

Detailed description:
Recurrent digital ulcers (DU) are a manifestation of vascular disease in patients with systemic sclerosis (SSc), are an important source of morbidity and lead to impaired function in these patients. In this study, we are investigating whether treatment with the endothelin receptor antagonist, macitentan, decreases the development of new digital ulcers in patients with SSc. Macitentan is a highly potent, tissue-targeting dual endothelin receptor antagonist. Through complete blockade of endothelin action, macitentan is expected to protect tissue from the damaging effect of elevated endothelin. This therapy is not approved for the treatment of systemic sclerosis, but the use of an ERA is an attractive approach in combating the structural vascular damage observed in SSc leading to complications such as DUs.

Arms: arm 1: Oral macitentan 3 mg, once daily arm 2: Oral macitentan 10 mg, once daily arm 3: Oral placebo, once daily
Interventions: intervention 1: Macitentan 3 mg intervention 2: Macitentan 10 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Macitentan 3-mg tablet once daily intervention 2: Macitentan 10-mg tablet once daily intervention 3: Placebo tablet matching macitentan tablet, once daily

Protocol documents:
Clinical trial NCT01485640
Conditions: Schizophrenia Bipolar Disorder
Keywords: Schizophrenia bipolar disorder Lurasidone Latuda
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2011-06-01; Completion date: 2014-02-01
Enrollment: 162 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment with lurasidone.

Detailed description:

Arms: arm 1: Lurasidone flexibly dosed
Interventions: intervention 1: Lurasidone
Intervention descriptions: intervention 1: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food

Protocol documents:
Clinical trial NCT01502228
Conditions: Renal Cell Carcinoma
Sponsor: Indiana University
Start date: 2011-10-01; Completion date: 2014-02-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Given the growing importance of anti-angiogenic therapies in the treatment of metastatic renal carcinoma, it is expected that this trial will establish the preliminary data needed to apply for funding of a larger clinical investigation of the potential role of PET perfusion imaging in management of renal carcinoma, and potentially other cancers.

Detailed description:

Arms: arm 1: CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection
Interventions: intervention 1: 150-Water intervention 2: 62Cu-ethylglyoxal bis intervention 3: Positron Emission Tomography intervention 4: Sunitinib
Intervention descriptions: intervention 1: Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV. intervention 2: Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV. intervention 3: PET Scan intervention 4: None

Protocol documents:
Clinical trial NCT01504477
Conditions: Colorectal Cancer
Keywords: colorectal cancer relapsed refractory Kras wild type
Sponsor: Georgetown University
Start date: 2011-12-01; Completion date: 2014-02-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Panitumumab plus bortezomib for colon cancer

Detailed description:
This study is for patients with colon cancer that cannot be fully removed by surgery and has come back after or not responded to standard chemotherapy treatment.

Subjects will be enrolled to either the first part of the study (Phase I) or the second part of the study (Phase II). Phase I will be completed before Phase II will start. The purpose of the Phase I part is to find the highest dose of bortezomib that can be given with panitumumab without causing severe side effects. The purpose of the Phase II part is to test the effects the two drugs have on subjects with colorectal cancer.

Panitumumab is a drug that targets a protein important for the growth of cancer cells known as EGFR. By blocking the activity of the protein, panitumumab can block cancer cell growth and even lead to their death. Panitumumab is given intravenously once every two weeks. Panitumumab is approved by the FDA for patients with colorectal cancer.

Bortezomib is a drug that targets a part of the cancer cell known as the proteosome. By inhibiting the proteosome, bortezomib can inhibit cancer cell growth and even lead to their death. Bortezomib is given intravenously, once a week, 3 out of every 4 weeks. Bortezomib is not FDA approved for the treatment of colorectal cancer.

As part of this study the investigators will be taking biopsies of patients' tumors before any treatment, after starting with the panitumumab alone, and after receiving both the panitumumab and bortezomib. The investigators want to investigate what markers inside tumors may relate to how well these two medications work. These biopsies are required as part of the study.

Arms: arm 1: IV panitumumab and bortezomib
Interventions: intervention 1: Panitumumab and bortezomib
Intervention descriptions: intervention 1: Panitumumab 6 mg/kg IV over 60 minutes on Day -14 (first cycle only), then Day 1 and 15 of each 28-day cycle.

Bortezomib will be administered in escalating doses until the maximum tolerated dose is determined and then at the maximum tolerated dose as an IV bolus injection over 3-5 seconds on Day 1, 8, and 15 of each 28-day cycle.

Protocol documents:
Clinical trial NCT01533428
Conditions: Diabetic Peripheral Neuropathy Pain
Keywords: Painful Diabetic Peripheral Neuropathy, Capsaicin 8% transdermal delivery system
Sponsor: Astellas Pharma Inc
Start date: 2012-02-01; Completion date: 2014-02-01
Enrollment: 369 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess efficacy and safety of a single treatment of Capsaicin 8% transdermal delivery system in reducing pain from damaged nerves (neuropathic pain) caused by diabetes.

Detailed description:
Participants were divided into 2 groups of approximately equal size. In the first group, participants received a Capsaicin 8% patch applied for 30 minutes to the feet; in the second group, participants received a placebo patch applied for 30 minutes to the feet. Participants were involved in the study for approximately 12 weeks and have visited the clinic approximately 6 times.

Arms: arm 1: Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1 arm 2: Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
Interventions: intervention 1: Capsaicin 8% intervention 2: Placebo
Intervention descriptions: intervention 1: Capsaicin 8% transdermal delivery system intervention 2: Placebo Patch

Protocol documents:
Clinical trial NCT01533597
Conditions: Overactive Bladder
Keywords: Overactive bladder Solifenacin succinate Tamsulosin
Sponsor: Soonchunhyang University Hospital
Start date: 2010-12-01; Completion date: 2014-02-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to investigate if the combination therapy consisting of anticholinergics plus alpha-blockers could be beneficial for women suffering from Overactive Bladder (OAB).

Detailed description:
Overactive bladder (OAB) describes the symptom complex of urgency, with or without urge incontinence, usually with frequency and nocturia.

The lower urinary tract is innervated by both the parasympathetic and the sympathetic nervous system, that act via muscarinic and adrenergic receptors, respectively.

Antimuscarinics are mainly used for the treatment of patients with OAB, especially women. Other than antimuscarinics, a1-blockers have been shown in several clinical reports to be useful in treating DO caused by neurological diseases.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Solifenacin intervention 2: Solifenacin plus Tamsulosin
Intervention descriptions: intervention 1: Solifenacin (5mg, qd, oral) intervention 2: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)

Protocol documents:
Clinical trial NCT01555138
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease Indacaterol Salmeterol/fluticasone propionate
Sponsor: Novartis Pharmaceuticals
Start date: 2012-02-01; Completion date: 2014-02-01
Enrollment: 581 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effectiveness and safety of indacaterol with salmeterol /fluticasone propionate treatment in patients with moderate chronic obstructive pulmonary disease who, on entry to the study are being treated with salmeterol /fluticasone propionate.

Detailed description:

Arms: arm 1: Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®) arm 2: Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
Interventions: intervention 1: Indacaterol intervention 2: Salmeterol
Intervention descriptions: intervention 1: Indacaterol is delivered via a SDDPI. intervention 2: Salmeterol/fluticasone is delivered via a MDDPI

Protocol documents:
Clinical trial NCT01559922
Conditions: Atrophic Acne Scar
Keywords: Acne
Sponsor: Suneva Medical, Inc.
Start date: 2012-02-01; Completion date: 2014-02-01
Enrollment: 175 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Artefill is safe and effective for the correction of atrophic facial acne scars.

Detailed description:
This is a multi-center, randomized, double-blind, placebo-controlled study assessing the efficacy and safety of Artefill for correction of moderate to severe atrophic acne scars.

The study is divided into two study periods. In Period I, scars meeting the treatment criteria will be individually identified, numbered and mapped using photographs and transparent sheets prior to treatment. This mapping will be used to track individual scars throughout the trial. Four (4) weeks following a baseline qualification visit, subjects randomized to treatment will receive one treatment of Artefill or Control (saline), administered by the Treating Investigator. At 72 hours following injections, subjects will be followed-up by telephone to confirm the occurrence of any AEs. Subjects will return to the clinic at 2 weeks for follow-up evaluation, and then at 4 weeks where subjects may receive one optional touch-up treatment. Subjects receiving touch-up treatment will be followed-up by telephone at 72 hours to confirm the occurrence of any AEs, and return for clinic visits at 6 weeks and 8 weeks. All subjects will then return for clinic follow-up at months 3 and 6 (after last treatment).

Period II is open label and will begin at month 6. Artefill group subjects will return to the clinic for assessments at months 9 and 12 (Track A) and Control group subjects will enter Track B, re-establish baseline, and complete additional month 6 visit activities including Artefill treatment. Subjects will receive touch up (if required) 4 weeks later, and be followed for an additional 12 months.

Subjects will be required to abstain from other aesthetic treatment to their face during the study period and failure to do so will be considered a protocol violation. However, if a subject does receive additional aesthetic or non-aesthetic treatments, available information on such treatment will be collected and the subject will be continued to be followed per protocol. Such subjects will not be excluded from the analysis, but will also be evaluated separately.

Arms: arm 1: Normal Saline arm 2: Dermal Filler
Interventions: intervention 1: Normal Saline intervention 2: Artefill
Intervention descriptions: intervention 1: Administration of up to 2 study treatments administered 6 weeks apart intervention 2: Administration of up to 2 study treatments administered 6 weeks apart

Protocol documents:
Clinical trial NCT01564862
Conditions: Depressive Disorder, Major
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2012-04-01; Completion date: 2014-02-01
Enrollment: 602 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of Lu AA21004, once daily (QD), on cognitive dysfunction in patients with major depressive disorder.

Detailed description:
Lu AA21004 is under codevelopment by Takeda Global Research \& Development Center, Inc. and H. Lundbeck A/S for the treatment of MDD.

This study will consist of a screening period within 10 days of the Baseline Visit followed by an 8-week double-blind treatment period and a one-week taper down period.

Arms: arm 1: Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. arm 2: Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period. arm 3: Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
Interventions: intervention 1: vortioxetine (Lu AA21004) intervention 2: Duloxetine intervention 3: Placebo
Intervention descriptions: intervention 1: Lu AA21004 capsules intervention 2: Duloxetine capsules intervention 3: Placebo matching capsules

Protocol documents: