ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01340872
Conditions: Iron Deficiency Anaemia Inflammatory Bowel Disease Ulcerative Colitis
Keywords: iron deficiency anaemia inflammatory bowel disease ulcerative colitis
Sponsor: Shield Therapeutics
Start date: 2011-08-01; Completion date: 2014-10-01
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether ST10-021, an oral ferric iron preparation, is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with non-active ulcerative colitis (UC).

Detailed description:
As no curative treatment is currently available for ulcerative colitis (UC), treatment options are restricted to controlling symptoms, maintaining remission and preventing relapse. As such, treatment of iron deficiency anaemia (IDA), a key symptom of the disease, is integral to the medical management of UC. Iron deficiency anaemia in UC is a chronically debilitating disorder which has a significant impact on the quality of life of affected subjects. Characteristic symptoms of IDA include chronic fatigue, headache, and subtle impairment of cognitive function. Up to one third of subjects with UC suffer from recurrent anaemia, with hospitalization required in severe cases. First line standard therapy for mild to moderate IDA in UC is typically oral ferrous products (OFP), however this is often not successful. Many subjects are intolerant and suffer from continuously occurring side effects, occasional exacerbation of inflammatory lesions and failure to correct iron deficiency. Common adverse effects of OFP include nausea, epigastric discomfort and constipation, all of which are dose-related and appear especially evident in subjects with UC.

As compared to oral ferrous iron, oral ferric iron can be administered with improved tolerability and the total dose exposure of unabsorbed iron within the gastrointestinal tract is significantly reduced. In addition, the iron is retained in its chelated form if not absorbed and this may reduce the risk of irritation within the gastrointestinal tract. Clinical studies conducted to date provide preliminary evidence for the therapeutic potential of ST10-021 in patients with IDA in Inflammatory Bowel Disease, including UC.

The purpose of this study is to determine whether ST10-021 is safe and effective in the treatment of IDA in subjects with non-active UC. In an effort to target an underserved population, the study will include only those subjects who have failed OFP in the past, or where OFP cannot be used.

Arms: arm 1: ST10 (Ferric Maltol) 30mg capsules, taken orally twice a day arm 2: Matching placebo capsules for ST10 (Ferric Maltol), taken orally twice a day
Interventions: intervention 1: ST10-021 intervention 2: Placebo Comparator
Intervention descriptions: intervention 1: 30 mg capsules to be taken orally twice a day for 12 weeks intervention 2: Matching sugar pill to be taken orally twice a day for 12 weeks

Protocol documents:
Clinical trial NCT01343004
Conditions: Osteoporosis Postmenopausal Osteoporosis
Keywords: BA058 abaloparatide Abaloparatide-SC osteoporosis postmenopausal bone loss ACTIVE fracture
Sponsor: Radius Health, Inc.
Start date: 2011-04-01; Completion date: 2014-10-01
Enrollment: 2463 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.

Detailed description:
This is a randomized, double-blind, placebo-controlled, comparative Phase 3, multicenter international study to evaluate the efficacy and safety of BA058 (abaloparatide) 80 µg in the prevention of fracture in otherwise healthy ambulatory postmenopausal women with severe osteoporosis.

Arms: arm 1: Placebo identical in appearance to BA058 study drug arm 2: None arm 3: Blinded until after randomization, then open-label
Interventions: intervention 1: Placebo intervention 2: BA058 80 mcg intervention 3: teriparatide
Intervention descriptions: intervention 1: Placebo 0 mcg subcutaneous daily intervention 2: BA058 80 mcg subcutaneous daily intervention 3: teriparatide 20 mcg subcutaneous daily

Protocol documents:
Clinical trial NCT01352221
Conditions: Iron Deficiency Anaemia Inflammatory Bowel Disease Crohn's Disease
Keywords: iron deficiency anaemia inflammatory bowel disease Crohn's Disease
Sponsor: Shield Therapeutics
Start date: 2011-08-01; Completion date: 2014-10-01
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether ST10-021, an oral ferric iron preparation, is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with non-active Crohn's Disease (CD).

Detailed description:
As no curative treatment is currently available for Crohn's Disease (CD), treatment options are restricted to controlling symptoms, maintaining remission and preventing relapse. As such, treatment of iron deficiency anaemia (IDA), a key symptom of the disease, is integral to the medical management of CD. Iron deficiency anaemia in CD is a chronically debilitating disorder which has a significant impact on the quality of life of affected subjects. Characteristic symptoms of IDA include chronic fatigue, headache, and subtle impairment of cognitive function. Up to one third of subjects with CD suffer from recurrent anaemia, with hospitalization required in severe cases. First line standard therapy for mild to moderate IDA in CD is typically oral ferrous products (OFP), however this is often not successful. Many subjects are intolerant and suffer from continuously occurring side effects, occasional exacerbation of inflammatory lesions and failure to correct iron deficiency. Common adverse effects of OFP include nausea, epigastric discomfort and constipation, all of which are dose-related and appear especially evident in subjects with CD.

As compared to oral ferrous iron, oral ferric iron can be administered with improved tolerability and the total dose exposure of unabsorbed iron within the gastrointestinal tract is significantly reduced. In addition, the iron is retained in its chelated form if not absorbed and this may reduce the risk of irritation within the gastrointestinal tract. Clinical studies conducted to date provide preliminary evidence for the therapeutic potential of ST10-021 in patients with IDA in Inflammatory Bowel Disease, including CD.

The purpose of this study is to determine whether ST10-021 is safe and effective in the treatment of IDA in subjects with non-active CD. In an effort to target an underserved population, the study will include only those subjects who have failed OFP in the past, or where OFP cannot be used.

Arms: arm 1: ST10 (Ferric Maltol) 30mg capsules, taken orally twice a day arm 2: Matching placebo capsules for ST10 (Ferric Maltol), taken orally twice a day
Interventions: intervention 1: ST10 intervention 2: Placebo oral capsule
Intervention descriptions: intervention 1: 30 mg capsules to be taken orally twice a day for 12 weeks in double-blind phase intervention 2: Matching placebo capsules for ST10 to be taken orally twice a day for 12 weeks in double-blind phase

Protocol documents:
Clinical trial NCT01354145
Conditions: Knee Osteoarthritis
Sponsor: Bioiberica
Start date: 2011-06-01; Completion date: 2014-10-01
Enrollment: 194 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to compare the cartilage volume loss at the Baseline visit and after 24 months of treatment in patients treated with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily vs. patients treated with CELECOXIB 200 mg daily.

Detailed description:
To compare long term disease modifiying and symptomatic effects at the Baseline visit and after 24 months of treatment in patients treated with CHONDROITIN SULPHATE 1200 mg daily vs. patients treated with CELECOXIB 200 mg daily.

Arms: arm 1: CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning arm 2: CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
Interventions: intervention 1: Chondroitin sulfate intervention 2: Celecoxib
Intervention descriptions: intervention 1: Chondroitin sulphate 1200 mg/day, 24 months treatment period intervention 2: Celecoxib 200 mg/day, 24 months treatment period

Protocol documents:
Clinical trial NCT01372202
Conditions: Esophageal Cancer
Keywords: Operable Based on CHFR Methylation Status Diagnostic Biopsies
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2011-06-01; Completion date: 2014-10-01
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2 Study of Paclitaxel with Cisplatin versus Fluoropyrimidine with a Platinum Agent for Neoadjuvant Therapy in Operable Esophageal Cancer Based on CHFR Methylation Status in Diagnostic Biopsies.

Detailed description:
Primary Objectives

• To determine the rate of pathological complete response when the inclusion of paclitaxel in neoadjuvant therapy is based on the presence or absence of CHFR methylation in diagnostic biopsy specimens.

Secondary Objectives

* To determine the survival outcome with this treatment strategy.
* To determine time to disease progression with this treatment strategy.
* To determine the agreement between tumor CHFR methylation and detection in plasma.

Arms: arm 1: Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy arm 2: Cisplatin or Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy arm 3: Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
Interventions: intervention 1: Paclitaxel intervention 2: Cisplatin intervention 3: Oxaliplatin intervention 4: 5-Fluorouracil intervention 5: Radiotherapy intervention 6: Esophagectomy
Intervention descriptions: intervention 1: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. intervention 2: Paclitaxel and cisplatin:

* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.

Cisplatin and 5-fluorouracil:

* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
* Cisplatin 75 mg/m² days 1, 29. intervention 3: Oxaliplatin 85 mg/m2 days 1, 15, 29. intervention 4: Oxaliplatin and 5-fluorouracil:

* Oxaliplatin 85 mg/m2 days 1, 15, 29.
* 5-Fluorouracil 180 mg/m2 prolonged infusion starting day 1 of radiation and completing on the final day of radiation (up to 40 days)

Cisplatin and 5-fluorouracil:

* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.
* Cisplatin 75 mg/m² days 1, 29. intervention 5: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy. intervention 6: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56).

Protocol documents:
Clinical trial NCT01380769
Conditions: Non-Small Cell Lung Cancer
Sponsor: NewLink Genetics Corporation
Start date: 2011-06-01; Completion date: 2014-10-01
Enrollment: 157 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare median overall survival of patients with advanced non-small cell lung cancer (NSCLC) treated with CRLX101 to patients treated with best supportive care (BSC).

Detailed description:
Lung cancer remains the leading cause of cancer-related mortality in men and women worldwide. Non-small cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancer. The development of targeted therapies has changed the approach to treating NSCLC significantly over the past decade with targeted therapies generally possessing safety advantages over traditional cytotoxic regimens. However, combination paradigms and resistance patterns complicate the use of these agents. CRLX101 is a nanoparticle comprised of camptothecin (CPT) conjugated to a cyclodextrin-based polymer. CRLX101 is designed to increase the exposure of tumor cells to CPT while minimizing side effects.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CRLX101 intervention 2: Best Supportive Care
Intervention descriptions: intervention 1: CRLX101 is administered at 15mg/m2 IV every other week intervention 2: best supportive care

Protocol documents:
Clinical trial NCT01392326
Conditions: Psoriatic Arthritis
Keywords: Psoriatic arthritis PsA ACR CASPAR
Sponsor: Novartis Pharmaceuticals
Start date: 2011-09-01; Completion date: 2014-10-01
Enrollment: 606 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy and safety of secukinumab in patients with active psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

Detailed description:

Arms: arm 1: Secukinumab (75mg) arm 2: Secukinumab (150 mg) arm 3: None
Interventions: intervention 1: Secukinumab (75 mg) intervention 2: Secukinumab (150 mg) intervention 3: Placebo Comparator
Intervention descriptions: intervention 1: Secukinumab (75 mg) intervention 2: Secukinumab (150 mg) intervention 3: Placebo Comparator

Protocol documents:
Clinical trial NCT01405820
Conditions: Relapsing-Remitting Multiple Sclerosis
Sponsor: Biogen
Start date: 2011-08-01; Completion date: 2014-10-01
Enrollment: 290 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to explore the effects of multiple regimens of natalizumab on disease activity and safety in participants with relapsing-remitting Multiple Sclerosis (RRMS).

Detailed description:
This is a a dose and frequency (but not route of administration) blinded, prospective, randomized, dose-ranging study in patients with RRMS who have received natalizumab for at least 12 months according to the local prescribing guidelines. The study will explore dosing of natalizumab by subcutaneous and intravenous routes. Participants will be randomly assigned to 1 of 6 dosing regimens, blinded to natalizumab dose, but not route, for 60 weeks of treatment.

Arms: arm 1: Natalizumab 300 mg IV every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68. arm 2: Natalizumab 300 mg SC every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68. arm 3: Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68. arm 4: Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68. arm 5: Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68. arm 6: Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
Interventions: intervention 1: natalizumab IV intervention 2: natalizumab SC intervention 3: IV Placebo intervention 4: SC Placebo
Intervention descriptions: intervention 1: natalizumab for IV Infusion intervention 2: natalizumab for Subcutaneous Injection intervention 3: Intravenous placebo to natalizumab intervention 4: Subcutaneous placebo to natalizumab

Protocol documents:
Clinical trial NCT01413516
Conditions: Smoking Cessation
Keywords: Varenicline Placebo Inpatient
Sponsor: Stanford University
Start date: 2011-08-01; Completion date: 2014-10-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Investigator Initiated Research Award (IIR Award #WS981308) is a two-part pilot study that aims to examine acceptability and feasibility of varenicline use during an acute (72-hr) smoke-free hospitalization (Part 1) and 4-weeks post-hospitalization (Part 2).

Detailed description:
The sample will be hospitalized patients smoking at least 10 cigarettes/day prior to hospitalization. Intention to quit smoking will not be required for study participation. Using a double-blinded, placebo-controlled, randomized design, participants will receive varenicline (0.5 mg BID as tolerated) or placebo during their hospitalization (Part 1) and will continue their study medication (placebo or active drug) for 4 weeks post-hospitalization (Part 2). Abstinence status will be examined at 4 weeks post-hospitalization.

Arms: arm 1: Smoking cessation counseling with placebo comparator arm 2: Smoking cessation counseling with varenicline
Interventions: intervention 1: Smoking cessation counseling intervention 2: Placebo intervention 3: Varenicline
Intervention descriptions: intervention 1: Counseling sessions provided by a trained smoking counselor intervention 2: Sugar pill without any active medication intervention 3: Varenicline (an approved medication for smoking cessation)

Protocol documents:
Clinical trial NCT01421134
Conditions: Major Depressive Disorder With Mixed Features
Keywords: depression Lurasidone Latuda
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2011-09-01; Completion date: 2014-10-01
Enrollment: 211 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features.

Detailed description:

Arms: arm 1: Lurasidone 20, 40 or 60 mg arm 2: Placebo
Interventions: intervention 1: Lurasidone intervention 2: Placebo
Intervention descriptions: intervention 1: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks intervention 2: Placebo

Protocol documents:
Clinical trial NCT01426113
Conditions: Glaucoma
Sponsor: Allergan
Start date: 2011-09-01; Completion date: 2014-10-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and efficacy of a new formulation of bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of paediatric patients with glaucoma.

Detailed description:

Arms: arm 1: 1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks. arm 2: 1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
Interventions: intervention 1: bimatoprost ophthalmic solution formulation A intervention 2: timolol ophthalmic solution intervention 3: bimatoprost vehicle
Intervention descriptions: intervention 1: 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning for 6 weeks. intervention 2: 1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks. intervention 3: 1 drop of bimatoprost vehicle in the affected eye(s) in the morning for 6 weeks, followed by 1 drop of bimatoprost vehicle in the affected eye(s) in the evening for 6 weeks.

Protocol documents:
Clinical trial NCT01429441
Conditions: Vitreomacular Adhesion Including Macular Hole
Sponsor: ThromboGenics
Start date: 2011-10-01; Completion date: 2014-10-01
Enrollment: 220 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion / (VMT) including macular hole with ocriplasmin.

Detailed description:
The present study is designed to assess anatomical and functional outcomes following a single intravitreal injection of ocriplasmin 0.125mg in subjects with symptomatic vitreomacular adhesion (VMA)/ (VMT) including macular hole.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ocriplasmin intervention 2: Sham injection
Intervention descriptions: intervention 1: 0.125 mg single intravitreal injection intervention 2: Sham injection

Protocol documents:
Clinical trial NCT01431963
Conditions: Epilepsy
Sponsor: GlaxoSmithKline
Start date: 2011-09-01; Completion date: 2014-10-01
Enrollment: 70 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a multi-center, uncontrolled, open-label study conducted in Japan and South Korea to evaluate the efficacy and safety of lamotrigine monotherapy in subjects with newly diagnosed epilepsy and those with recurrent epilepsy (currently untreated).

The study is composed of baseline, escalation phase, maintenance phase, taper phase and post study examination. During the escalation phase, the investigational product is administered orally at 25 mg/day for 2 weeks, then 50 mg/day for 2 weeks and finally 100 mg/day for 2 weeks. During the maintenance phase, 200 mg/day is administered orally for 24 weeks. However, the dose can be decreased to 100 mg/day if there are safety concerns. Also, if it is confirmed that the seizures cannot be controlled at the dose of 200 mg/day, the dose can be gradually increased up to 400 mg/day by 50-100 mg/day at intervals of at least 1 week. As a rule, lamotrigine should be administered once daily (in the evening), but the dose exceeding 200 mg/day can be administered in two divided doses (in the morning and evening). After the completion of maintenance phase, Japanese subjects who have responded to lamotrigine without tolerability issues are eligible to enter an extension phase of the study if indicated, until either approval of this indication (monotherapy in epilepsy) or after 24 months after LSLV (Last Subject's Last Visit) of the maintenance phase, whichever is sooner.

Detailed description:

Arms: arm 1: No comparison.
Interventions: intervention 1: Lamictal
Intervention descriptions: intervention 1: No comparison.

Protocol documents:
Clinical trial NCT01434745
Conditions: Smith-Lemli-Opitz Syndrome
Keywords: SLOS Cholesterol Supplementation Simvastatin
Sponsor: Oregon Health and Science University
Start date: 2011-09-01; Completion date: 2014-10-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine if simvastatin improves development and behavior in patients with Smith Lemli-Opitz syndrome (SLOS) receiving dietary cholesterol supplementation.

Detailed description:
Patients with SLOS receiving dietary cholesterol supplementation are given simvastatin, a drug that decreases the activity/expression of HMG-CoA reductase, an enzyme that controls the first step of the cholesterol synthesis pathway, reduces the accumulation of toxic 7-dehydrocholesterol (immediate metabolic precursor of cholesterol) and improve neurocognitive and behavioral outcomes.

Arms: arm 1: placebo arm 2: 0.5 mg/kg body weight/day
Interventions: intervention 1: Simvastatin intervention 2: Lactose
Intervention descriptions: intervention 1: Simvastatin will be administered as a powder mixed with lactose at the dose of 0.5 mg/kg/day intervention 2: Lactose will be administered in a capsule formula.

Protocol documents: