ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00865189
Conditions: Rectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2007-10-23; Completion date: 2016-03-23
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy and safety of two different neoadjuvant treatment approaches including bevacizumab in newly diagnosed participants with high risk locally advanced rectal cancer. Participants will be randomized into one of two treatment arms (Arm A or Arm B).

Detailed description:

Arms: arm 1: In this arm, participants will undergo 3 phases of treatment. During the Phase 1, participants will receive induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 will include 7 weeks of bevacizumab + chemoradiotherapy (intravenous \[IV\] infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy \[5-FU + radiotherapy\], with administration of bevacizumab every two weeks \[Cycles 1, 3 and 5\]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 will be surgery involving a radical rectal excision using the total mesorectal excision (TME) technique. arm 2: In this arm, participants will receive the Phase 2 and Phase 3 treatments only. The phase 2 will include 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy \[5-FU + radiotherapy\], with administration of bevacizumab every two weeks \[Cycles 1, 3 and 5\]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 will be surgery involving a radical rectal excision using the TME technique.
Interventions: intervention 1: Bevacizumab intervention 2: Oxaliplatin intervention 3: Folinic Acid intervention 4: 5-fluorouracil intervention 5: Preoperative Radiotherapy intervention 6: Surgery
Intervention descriptions: intervention 1: Bevacizumab will be administered at the fixed dose of 5 milligrams per kilogram (mg/kg) as an IV infusion over 30 to 90 minutes. intervention 2: Oxaliplatin will be administered at a dose of 85 milligrams per square meter (mg/m\^2) as a 2-hour IV infusion. intervention 3: Folinic acid will be administered at a dose of 200 mg/m\^2 as a 2-hour infusion. intervention 4: 5-fluorouracil will be administered at a dose of 400 mg/m\^2 as an IV bolus, then at a dose of 600 mg/m\^2 as a continuous infusion for 22 hours in Phase 1, and will be administered at a dose of 225 mg/m\^2 as a 24-hour infusion, 5 days a week, for 5 weeks in Phase 2. intervention 5: Radiotherapy will be delivered in fraction of 1.8 gray per day (Gy/day), 5 days a week for 5 weeks, i.e., a total dose of 45 Gy will be administered in 25 fractions over a period of 33 days. intervention 6: Radical rectal excision based on the TME technique.

Protocol documents:
Clinical trial NCT01843348
Conditions: Kidney Transplantation Renal Transplantation
Keywords: Transplant Renal transplant Rejection,allograf Rejection Xenograft rejection Host vs graft disease Kidney Transplant
Sponsor: Novartis Pharmaceuticals
Start date: 2012-12-27; Completion date: 2016-03-23
Enrollment: 612 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to evaluate the renal function comparing Certican based immunosuppressive regimens with two different CNIs (Tacrolimus or Cyclosporin A) versus a standard treatment with Mycophenolic Acid and Tacrolimus in de novo renal transplant recipients.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Everolimus intervention 2: Tacrolimus intervention 3: Cyclosporin A intervention 4: Enteric Coated Mycophenolate Sodium (EC-MPS) intervention 5: Mycophenolate mofetil (MMF) intervention 6: Corticosteroids intervention 7: Simulect
Intervention descriptions: intervention 1: None intervention 2: Capsules: 0.5 mg, 1 mg or 5 mg. Dosing schedule: transplant to month 2: 4-8ng/ml, month 3 to month 12 3-5 ng/ml according to standard blood levels intervention 3: Capsules: 10 mg, 25 mg, 50 mg or 100 mg. Transplantation to month 2: 75 - 125 ng/ml, month 3 to month 12: 50 - 100 ng/ml intervention 4: Tablets: 180 mg or 360 mg. Dosing: duration of study 360 mg bid and no less than 360 mg daily dose intervention 5: Capsules: 250 or 500 mg. Dosing: duration of study 500 mg bid and no less than 500 mg total daily dose intervention 6: A minimum dose of 5 mg prednisolon or equivalent intervention 7: Lyophilisate in vials with ampoules of sterile water for injection (5 mL), one vial containing 20 mg lyophilisate given intravenously on the day of transplantation and on day four post-transplantation.

Protocol documents:
Clinical trial NCT02613910
Conditions: Pemphigus
Keywords: Ofatumumab Pemphigus Vulgaris Long-Term Extension Study
Sponsor: GlaxoSmithKline
Start date: 2015-12-23; Completion date: 2016-03-23
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed as a multi-country, multicenter, open label extension to Phase III trial OPV116910. The primary objective is to provide continued treatment with ofatumumab subcutaneous (SC) for eligible subjects who complete the OPV116910 trial in order to obtain further long term safety and tolerability information in subjects with pemphigus vulgaris receiving ofatumumab SC every 4 weeks (wk).

Detailed description:

Arms: arm 1: t the Baseline (Bln) and wk 4 visits, Subjects will receive 40mg ofatumumab sc (Oft) (as two 20mg sc inj) and as 1 Oft 20mg sc inj every 4 wks from wk 8 through wk 56. Subjects will return to clinic 4 wks after the last dose for a follow-up (f/u) visit (wk 60). Antihistamine 10 mg and Acetaminophen/paracetamol (A/P) 1 grams(g) will be given 1-2 hours(h) before and 4 h after each dose of Oft. A/P 1 g will be supplied for self administration if needed. Prednisone/Prednisolone dose will continue to be tapered during core study period (CSP) by 1 dose level every 2 wks to \<= 10 mg/day from Bln through wk 60. Upon completion of the CSP, subjects will enter Individualized f/u Period, where subjects will monitored every 12 wks for a minimum of 1 yr and for up to 2 yr, until CD19+ B-LC or IgG recover to lower limit of normal (LLN) or to the subject's Bln value from Study OPV116910 (if \<LLN) or if study withdrawal criteria are met or for a maximum of 2 yr after the last dose of Oft.
Interventions: intervention 1: Ofatumumab intervention 2: Acetaminophen/paracetamol intervention 3: Antihistamine (cetirizine or equivalent) intervention 4: Prednisone/Prednisolone
Intervention descriptions: intervention 1: Ofatumumab (human monoclonal antibody) will be provided as a liquid concentrate in a prefilled glass syringe with staked needle, stopper, and plunger containing 0.4 millilitre (mL) (20 mg) drug product of 50 mg/mL concentration intervention 2: Acetaminophen/paracetamol will be supplied by study centre as 1 gram tablet, caplet, capsule or liquid for oral administration intervention 3: Antihistamine (cetirizine or equivalent) will be supplied by study center as 10 mg tablet, caplet, capsule or liquid for oral administration intervention 4: Prednisone/Prednisolone will be supplied from the dose range 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 25, 30, 40, 50, 60, 80, 100, 120, 140, 160, 180, 200, 220 and 240 mg for oral administration

Protocol documents:
Clinical trial NCT02732587
Conditions: Alcohol Drinking
Sponsor: Yale University
Start date: 2015-11-01; Completion date: 2016-03-23
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this alcohol-interaction pilot study is to provide information on the effect of AZD0530 (Saracatinib) on the pharmacokinetics of alcohol and on alcohol responses, including stimulation, sedation, intoxication, body sway and physiological responses. The investigators propose to test the effects of a single dose of AZD0530 (125 mg) on alcohol related responses. This is a within subjects open label study in which the investigators plan to run 8 subjects to obtain 5 completers.

Detailed description:
The purpose of this alcohol-interaction pilot study is to provide information on the effect of AZD0530 (Saracatinib) on the pharmacokinetics of alcohol and on alcohol responses, including stimulation, sedation, intoxication, body sway and physiological responses. The investigators propose to test the effects of a single dose of AZD0530 (125 mg) on alcohol related responses. This is a within subjects open label study in which the investigators plan to run 8 subjects to obtain 5 completers.

Subjects will participate in two lab sessions, one prior to taking medication and one following 8-11 days of AZD0530. During each session, participants will receive successive doses of alcohol over a 90 min period designed to raise their blood alcohol levels to 80 mg/dl; this dose was chosen because this is close to the legal limit of intoxication and to the peak blood alcohol content (BAC) we have observed in prior research studies.Subjects will be monitored throughout the lab session and will receive a phone call two days following the 2nd lab session and a follow-up appointment one week after the 2nd lab session to assess any remaining side effects from the medication.

Once it is determined that there is no change in the pharmacokinetics of alcohol or AZD0530, as well as no difference in behavioral or cognitive responses to alcohol in the presence of AZD0530, the investigators will begin the pilot study examining the effects of two doses of AZD0530 on behavioral measures related to alcohol self-administration following a fixed dose of alcohol in alcohol abusive or dependent heavy drinkers, and compare responses to those obtained from historical controls who were treated with placebo in Study 1. Subjects will be randomized to one of two doses of AZD0530 (50 mg/day or 125 mg/day) as a between subjects factor.

Arms: arm 1: 125 mg Saracatinib once daily for 8-11 days
Interventions: intervention 1: Saracatinib
Intervention descriptions: intervention 1: Subjects will receive 125 mg Saracatinib for 8-11 days followed by an alcohol interaction lab session

Protocol documents:
Clinical trial NCT02554981
Conditions: Dry Eye Syndromes
Sponsor: Allergan
Start date: 2015-07-21; Completion date: 2016-03-24
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy of Restasis® in participants with dry eye disease who engage in electronic visual tasking.

Detailed description:

Arms: arm 1: 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Interventions: intervention 1: Cyclosporine 0.05% Ophthalmic Emulsion
Intervention descriptions: intervention 1: Cyclosporine 0.05% Ophthalmic Emulsion (RESTASIS®) 1 drop instilled in each eye twice a day.

Protocol documents:
Clinical trial NCT02604407
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Sponsor: Shire
Start date: 2015-11-19; Completion date: 2016-03-24
Enrollment: 275 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to evaluate the efficacy and safety of each dose of SHP465 (12.5 and 37.5 mg) given to participants daily in the morning compared to placebo in the treatment of adults aged 18 to 55 years diagnosed with ADHD.

Detailed description:

Arms: arm 1: Subjects will receive SHP465 12.5 mg arm 2: Subjects will receive SHP465 titrated up to 37.5 mg arm 3: Subjects will receive matching placebo
Interventions: intervention 1: SHP465 12.5mg capsules (one capsule daily) intervention 2: Placebo intervention 3: SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily)
Intervention descriptions: intervention 1: one capsule daily intervention 2: Matching placebo capsule that appears identical in size, weight, shape, and color (one capsule daily) intervention 3: One capsule daily

Protocol documents:
Clinical trial NCT01331837
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2011-08-02; Completion date: 2016-03-25
Enrollment: 3080 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, open-label, parallel-group, multicenter study will evaluate the rate of cardiovascular events with tocilizumab in comparison to etanercept in participants with rheumatoid arthritis (RA). Participants will be randomized to receive intravenous (IV) 8 milligrams per kilogram (mg/kg) tocilizumab every 4 weeks or subcutaneous 50 milligrams (mg) etanercept weekly, with or without non-biologic disease-modifying anti-rheumatic drug (DMARD).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Etanercept intervention 2: Tocilizumab
Intervention descriptions: intervention 1: Participants will receive 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years. intervention 2: Participants will receive 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.

Protocol documents:
Clinical trial NCT02037776
Conditions: Functional Dyspepsia
Keywords: Rikkunshito Double blind Functional dyspepsia (FD)
Sponsor: Osaka City University
Start date: 2014-04-03; Completion date: 2016-03-25
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of Rikkunshito compared to placebo in Japanese subjects with Functional Dyspepsia (FD).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rikkunshito intervention 2: Rikkunshito placebo
Intervention descriptions: intervention 1: \- Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks intervention 2: \- Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks

Protocol documents:
Clinical trial NCT02256540
Conditions: Endothelial Dysfunction
Sponsor: University of Colorado, Denver
Start date: 2014-08-01; Completion date: 2016-03-25
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This pilot study plans to learn more about the aging of blood vessels and arteries in women. As women age and go through menopause, their risk for cardiovascular disease increases. Also with aging and menopause, levels of the reproductive hormone estradiol decline. Hormone replacement therapy to restore estradiol levels does not protect women from cardiovascular disease, so lifestyle changes, such as regular exercise, are recommended to reduce disease risk. However, there are differences between men and women in their response to exercise. In older men, exercise improves the health of their arteries, but in postmenopausal women, exercise does not provide this benefit. The purpose of this pilot study is to determine whether low estradiol levels in postmenopausal women are responsible for the poor vascular response to exercise. In this study the investigators will also test whether treatment with resveratrol, a plant compound found in red wine, improves postmenopausal women's response to exercise. The investigators hypothesize that acute treatment with estrogen or resveratrol will improve vascular responses to an acute bout of exercise.

Detailed description:

Arms: arm 1: Postmenopausal women will be given a placebo patch to wear two days prior to exercise visit and a placebo tablet to take the morning of the exercise visit. arm 2: Postmenopausal women will be given a placebo patch to wear for two days prior to the exercise visit and a resveratrol tablet (dosed at 250mg) to take the morning of the exercise visit. arm 3: Postmenopausal women will be given a transdermal estrogen patch to wear (0.05mg/day) for two days prior to the exercise visit and a placebo tablet to take the morning of the exercise visit.
Interventions: intervention 1: Climara intervention 2: Placebo patch intervention 3: Resveratrol intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: Placebo patch designed to match active Climara patches. intervention 3: None intervention 4: Placebo tablets designed to match active resveratrol tablets.

Protocol documents:
Clinical trial NCT02433834
Conditions: Asthma
Sponsor: Pearl Therapeutics, Inc.
Start date: 2015-05-27; Completion date: 2016-03-26
Enrollment: 248 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A Randomized, Double-Blind, Chronic Dosing (14 days), 5-Period, 7-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-center, Dose-ranging Study to Assess the Efficacy and Safety of Glycopyrronium MDI (PT001) Relative to Placebo MDI and Open-Label Serevent Diskus in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent Asthma

Detailed description:

Arms: arm 1: GP MDI (PT001) 28.8 μg arm 2: GP MDI (PT001) 14.4 μg arm 3: GP MDI (PT001) 7.2 μg arm 4: GP MDI (PT001) 3.6 μg arm 5: GP MDI (PT001) 1.9 μg arm 6: Placebo arm 7: Serevent® Diskus® 50 μg per inhalation
Interventions: intervention 1: Glycopyrronium MDI intervention 2: Serevent Diskus 50 μg intervention 3: Placebo
Intervention descriptions: intervention 1: GP MDI intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01976338
Conditions: Macular Edema Secondary to Branch Retinal Vein Occlusion
Keywords: BRVO macular edema vision impairment retinal vein occlusion ranibizumab branch retinal vein occlusion anti-VEGF therapy RFB002
Sponsor: Novartis Pharmaceuticals
Start date: 2013-11-12; Completion date: 2016-03-28
Enrollment: 283 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Provided efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to BRVO

Detailed description:

Arms: arm 1: PRN Intravitreal injection arm 2: As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
Interventions: intervention 1: Ranibizumab 0.5 mg intervention 2: Sham injection
Intervention descriptions: intervention 1: intravitreal injection of 0.05 ml intervention 2: Sham intravitreal injection

Protocol documents:
Clinical trial NCT01685060
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer NSCLC ALK LDK378 Ceritinib
Sponsor: Novartis Pharmaceuticals
Start date: 2012-11-26; Completion date: 2016-03-29
Enrollment: 140 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anti-cancer therapy and/or died. LDK378 could be continued beyond RECIST-defined progressive disease (PD) as assessed by the investigator if, in the judgment of the investigator, there was evidence of clinical benefit. In these patients tumor assessment would continue as per the schedule of assessments until treatment with LDK378 was permanently discontinued. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator

Detailed description:

Arms: arm 1: Patients treated with ceritinib/LDK378 750 mg once-daily, fasted
Interventions: intervention 1: LDK378
Intervention descriptions: intervention 1: Ceritinib/LDK378 was supplied as 150 mg hard gelatin capsules and were administered orally, once-daily at a dose of 750 mg on a continuous dosing schedule (5 x 150 mg capsules).

Protocol documents:
Clinical trial NCT02063659
Conditions: Carcinoid Syndrome
Sponsor: Lexicon Pharmaceuticals
Start date: 2014-03-11; Completion date: 2016-03-29
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.

Detailed description:

Arms: arm 1: Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period. arm 2: Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period. arm 3: Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.
Interventions: intervention 1: Telotristat etiprate intervention 2: Placebo
Intervention descriptions: intervention 1: Telotristat etiprate tablets intervention 2: Placebo-matching telotristat etiprate tablets

Protocol documents:
Clinical trial NCT02147197
Conditions: Leiomyoma Uterine Hemorrhage
Sponsor: Allergan
Start date: 2014-03-31; Completion date: 2016-03-29
Enrollment: 157 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids

Detailed description:

Arms: arm 1: Ulipristal acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks. arm 2: UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks. arm 3: Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks.
Interventions: intervention 1: Ulipristal acetate (UPA) intervention 2: Placebo
Intervention descriptions: intervention 1: UPA tablet intervention 2: Matching placebo tablet.

Protocol documents: