ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02319486
Conditions: Retinoblastoma
Keywords: Retinoblastoma carboplatin
Sponsor: Sun Yat-sen University
Start date: 2009-01-01; Completion date: 2014-04-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate a uniform chemotherapy protocol for nonmetastatic extraocular retinoblastoma

Detailed description:
This study will be a phase 4 open label interventional case series. Patients with retinoblastoma will be receive chemotherapy with or without periocular injections of carboplatin at a dose of 20mg/2 ml. Patients will receive chemotherapy on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 18 months .

Arms: arm 1: CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection
Interventions: intervention 1: carboplatin periocular injection intervention 2: CEV chemotherapy
Intervention descriptions: intervention 1: chemotherapy together with/without 20mg/2ml carboplatin periocular injection intervention 2: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2

Protocol documents:
Clinical trial NCT02530528
Conditions: Surgery
Keywords: Surgical Skin Preparation
Sponsor: Medline Industries
Start date: 2014-02-01; Completion date: 2014-04-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pilot study to evaluate and compare activity of investigational preoperative preparation (2% CHG) with comparator (2% CHG).

Detailed description:
Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Various application times were evaluated. Efficacy was assess using the Tentative Final Monograph (TFM) criteria.

Arms: arm 1: single administration, 1 min application time arm 2: single administration, 2 min application time arm 3: single administration, 3 min application time arm 4: Single administration, Marketed CHG
Interventions: intervention 1: CHG
Intervention descriptions: intervention 1: Varied application times

Protocol documents:
Clinical trial NCT02587819
Conditions: Carcinoma, Basal Cell (BCC)
Sponsor: Biosceptre
Start date: 2013-05-01; Completion date: 2014-04-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 1, open-label, single-arm, multicenter study to assess the safety and tolerability of BSCT (anti-nf-P2X7) 10% Ointment in subjects with BCC.

Detailed description:
The purpose of the trial was to determine the safety and tolerability of BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days in male and female patients with BCC; and to determine the steady-state pharmacokinetics (PK) of the active pharmaceutical ingredient (total sheep Immunoglobulin G \[IgG\]) when BSCT (anti-nf-P2X7) 10% Ointment is applied twice daily to BCC lesions. This was an open-label, single-arm, multicenter Phase 1 study that enrolled 21 BCC patients.

Arms: arm 1: 21 patients with BCC were treated with BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days.
Interventions: intervention 1: Treatment with BSCT
Intervention descriptions: intervention 1: The study product BSCT (anti-nf-P2X7) 10% Ointment was anti-nf-P2X7 (highly purified sheep IgG) in an ointment formulation for topical administration. The formulation contained 10% weight by weight of the active pharmaceutical ingredient in an anhydrous ointment base.

Fifty (50) to 100 mg of product (an amount the size of a small pea) was applied topically twice a day for 28 days to a 25 cm2 area of skin containing a single BCC lesion. The product was to be applied in the morning and in the evening after washing.

Protocol documents:
Clinical trial NCT01863667
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-07-08; Completion date: 2014-04-03
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in type 2 diabetes mellitus participants who are metformin intolerant or who have a contraindication to the use of metformin. The primary hypothesis is that after 54 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with omarigliptin is non-inferior compared with that in participants treated with glimepiride.

Detailed description:

Arms: arm 1: Participants receive an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks. arm 2: Participants receive glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
Interventions: intervention 1: Omarigliptin intervention 2: Glimepiride intervention 3: Omarigliptin Placebo intervention 4: Glimepiride Placebo
Intervention descriptions: intervention 1: Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly intervention 2: Glimepiride tablet 1 mg and/or 2 mg (uptitrated to a maximum dose 6 mg/day) administered orally once daily with breakfast or the first main meal intervention 3: Matching placebo to omarigliptin capsule administered orally once weekly intervention 4: Matching placebo to glimepiride tablet administered orally once daily with breakfast or the first main meal

Protocol documents:
Clinical trial NCT02446496
Conditions: Infections, Urinary Tract
Keywords: Bioequivalence film coated tablets cefadroxil
Sponsor: GlaxoSmithKline
Start date: 2014-03-31; Completion date: 2014-04-08
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is an open-label, randomized, single dose, two-sequence two-period crossover study, separated by 7 days washout interval from the first Study Drug Administration. This study is conducted to determine the bioequivalence of cefadroxil from DURICEF™ film coated tablets manufactured by Smithkline Beecham Egypt, LLC affiliated co. to GalaxoSmithKline (GSK) and cefadroxil from BIODROXIL™ film coated tablets manufactured by Kahira Pharm \&amp;Chem .Ind. Co . for Novartis Pharma (NP) after a single oral dose administration of each to healthy adult subjects under fasting conditions. In Period 1, subjects will be randomized to receive cefadroxil tablet manufactured by either GSK or NP. Following a washout of at least 7 days, subjects will be crossed over in Period 2 to receive the cefadroxil tablet that they did not receive in Period 1. DURICEF is a trademark of the GSK group of companies. BIODROXIL is a trademark of Sandoz.

Detailed description:

Arms: arm 1: Subjects will receive a single oral dose of cefadroxil tablet manufactured by GSK under fasting condition in treatment period 1 followed by 7 days washout interval from the first study drug administration. After the washout interval the subjects will receive a single dose of cefadroxil tablet manufactured by NP under fasting condition in treatment period 2 arm 2: Subjects will receive a single oral dose of cefadroxil tablet manufactured by NP under fasting condition in treatment period 1 followed by 7 days washout interval from the first study drug administration. After the washout interval the subjects will receive a single dose of cefadroxil tablet manufactured by GSK under fasting condition in treatment period 2
Interventions: intervention 1: Cefadroxil tablets manufactured by GSK intervention 2: Cefadroxil tablets manufactured by NP
Intervention descriptions: intervention 1: Cefadroxil tablets manufactured by GSK contains 1 mg of Cefadroxil intervention 2: Cefadroxil tablets manufactured by NP contains 1 mg of Cefadroxil

Protocol documents:
Clinical trial NCT01098110
Conditions: Schizophrenia
Sponsor: Organon and Co
Start date: 2010-05-25; Completion date: 2014-04-14
Enrollment: 532 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multicenter, randomized, parallel-group, double-blind, fixed dose, 6-week trial of the efficacy and safety of asenapine compared with placebo in participants with an acute exacerbation of schizophrenia.

Detailed description:

Arms: arm 1: Participants received a 5 mg asenapine fast dissolving tablet twice daily (BID) for 6 weeks. arm 2: Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. arm 3: Participants received matching placebo BID for 6 weeks.
Interventions: intervention 1: Asenapine 5 mg intervention 2: Asenapine 10 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Asenapine 5 mg fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), on Day 1 only or for 6 weeks. intervention 2: Participants receive on Day 2, 10 mg BID of fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), for 6 weeks. intervention 3: A matching placebo of asenapine sublingual tablet not containing asenapine

Protocol documents:
Clinical trial NCT01675297
Conditions: Osteoporosis
Keywords: Risedronate, cholecalciferol, BMD
Sponsor: Hanlim Pharm. Co., Ltd.
Start date: 2011-07-04; Completion date: 2014-04-15
Enrollment: 1053 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis.

Detailed description:
The purpose of this study is to evaluate the efficacy and the safety of Risedronate with and without cholecalciferol on vitamin D status, Bone Mineral Density (BMD) and bone markers.

Arms: arm 1: Risendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months arm 2: Sedron tablet: one tablet once a week for 12months
Interventions: intervention 1: Risedronate/Cholecalciferol combination intervention 2: Risedronate
Intervention descriptions: intervention 1: Risendronate/Cholecalciferol combination once a week intervention 2: Risedronate once a week

Protocol documents:
Clinical trial NCT02037165
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-01-21; Completion date: 2014-04-15
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
* To investigate the influence of different doses of BI 1026706 on the primary endpoint (PtP-amplitude LEP in UV skin) compared to placebo.
* The comparison of both doses of BI 1026706 to celecoxib in the UVB treatment.
* Comparison of both doses of BI 1026706 to placebo and pregabalin in the capsaicin treatment
* Exploration of the pharmacokinetics of BI 1026706
* Exploration of safety and tolerability of BI 1026706

Detailed description:

Arms: arm 1: BI 1026706 plus matching placebo to BI 1026706 Powder for Oral Solution (PfOS) and placebo tablet arm 2: BI 1026706 and placebo tablet arm 3: Matching placebo to BI 1026706 PfOS and placebo tablet arm 4: Celecoxib hard capsule as active comparator plus matching placebo to BI 1026706 PfOS arm 5: Pregabalin hard capsule as active comparator plus matching placebo to BI 1026706 PfOS
Interventions: intervention 1: Placebo to BI 1026706 intervention 2: Pregabalin intervention 3: BI 1026706 intervention 4: Celecoxib
Intervention descriptions: intervention 1: Placebo tablet intervention 2: Pregabalin hard capsule intervention 3: BI 1026706 oral solution intervention 4: Celecoxib hard capsule

Protocol documents:
Clinical trial NCT01245140
Conditions: Psoriasis
Keywords: Palmo-Plantar Pustolosis
Sponsor: Stiefel, a GSK Company
Start date: 2011-04-26; Completion date: 2014-04-16
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to demonstrate the improvement in the skin condition rate of patients receiving alitretinoin compared to patients receiving placebo.

Detailed description:
Palmo-plantar pustulosis (PPP) is an inflammatory skin disease affecting palms and soles. The disease is considered as a sub-form of psoriasis and presents with sterile pustules of the palms and the soles. This study investigates the efficacy of alitretinoin in patients who have not responded to topical drugs (e.g., steroid creams), who are suffering for at least 6 month from the condition and whose disease severity is confirmed by a score.

Arms: arm 1: to receive study drug (alitretinoin, 20 patients) arm 2: to receive placebo (dummy drug, 10 patients)
Interventions: intervention 1: alitretinoin intervention 2: Placebo
Intervention descriptions: intervention 1: to receive verum (20 patients) intervention 2: to receive placebo (10 patients)

Protocol documents:
Clinical trial NCT01604941
Conditions: Iron Overload Due to Repeated Red Blood Cell Transfusions
Sponsor: Shire
Start date: 2012-09-14; Completion date: 2014-04-18
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate SSP-004184AQ in patients with transfusional iron overload whose primary diagnosis is hereditary or congenital anemia.

SSP-004184AQ is an iron chelator under development for chronic daily oral administration to patients with transfusional iron overload.

Detailed description:

Arms: arm 1: 50 mg/kg/day orally twice daily for 24 weeks
Interventions: intervention 1: SPD602
Intervention descriptions: intervention 1: 50 mg/kg/day orally twice daily for 24 weeks

Protocol documents:
Clinical trial NCT02091882
Conditions: Device Latency
Keywords: OPC-14597 Digital Aripiprazole Medical Information Device #1 System (MIND1) Ingestible Event Marker
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2014-03-21; Completion date: 2014-04-18
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.

Detailed description:
The OSMITTER study protocol was designed as a master protocol governing multiple substudies for the rapid assessment of candidate subcomponents for the MIND1 System. This substudy was conducted to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.

Arms: arm 1: Participants were placed a patch by the clinical staff prior to each ingestible event marker (IEM) tablet ingestion. Participants received one IEM tablet approximately every 2 hours, for a total of 4 ingestions on Day 1 at 0, 2, 4 and 6 hours.

Following placement of the patch by clinic staff, participants ingested one 10 mg aripiprazole-embedded IEM tablet without food at Hour 0, one placebo-embedded IEM tablet without food at approximately Hour 2, one placebo-embedded IEM tablet with a high fat meal at approximately Hour 4, and one placebo-embedded IEM tablet without food at approximately Hour 6. Clinic staff recorded the time of each ingestion of an IEM and the time detected by MIND1 System.
Interventions: intervention 1: Placebo intervention 2: Combination product of Aripiprazole + IEM + Sensor + MIND1 Application
Intervention descriptions: intervention 1: Oral placebo-embedded IEM tablet. intervention 2: Combination product of aripiprazole tablet embedded with sensor and wearable patch with MIND1 system on smartphone

Protocol documents:
Clinical trial NCT01000727
Conditions: Acute Coronary Syndrome
Keywords: Atherosclerosis Heart disease Cardiovascular disease Lp-PLA2 inhibitor The TIMI Study Group Coronary Heart Disease (CHD) Acute Coronary Syndrome (ACS)
Sponsor: GlaxoSmithKline
Start date: 2009-12-01; Completion date: 2014-04-24
Enrollment: 13026 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or urgent coronary revascularization (e.g. medical procedures performed to restore the normal blood flow in patients with atherosclerosis)) when treatment is started within 30 days after an acute coronary syndrome (also called ACS).

Detailed description:
Subjects who qualify for the study will be randomized 1:1 to either darapladib or placebo administered in addition to standard therapy. Following the baseline visit, subjects will be expected to return for clinic visits at 1 month, 3 months, 6 months and every 6 months until the end of the study.

Arms: arm 1: Single daily oral tablet arm 2: Single daily oral tablet
Interventions: intervention 1: Darapladib 160 mg intervention 2: Placebo intervention 3: Standard Therapy
Intervention descriptions: intervention 1: Lp-PLA2 inhibitor intervention 2: Placebo administered intervention 3: Guideline mandated therapy for individual's condition

Protocol documents:
Clinical trial NCT01671111
Conditions: Iron Overload Due to Repeated Red Blood Cell Transfusions
Sponsor: Shire
Start date: 2012-08-14; Completion date: 2014-04-24
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this extension study is to evaluate SSP-004184AQ in patients with transfusional iron overload and to provide data on long term safety and efficacy.

SSP-004184AQ is an iron chelator under development for chronic daily oral administration to patients with transfusional iron overload

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: SSP-004184AQ
Intervention descriptions: intervention 1: Long term extension study of 8-75 mg/kg/d of SSP-004184AQ (equivalent to 7-68 mg/kg/d free acid or "active" form)

Protocol documents:
Clinical trial NCT02080468
Conditions: Healthy
Keywords: Effect Ethinyl Estradiol/Norgestimate Pharmacokinetics Lomitapide.
Sponsor: Aegerion Pharmaceuticals, Inc.
Start date: 2014-02-19; Completion date: 2014-04-24
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess the effect of ethinyl estradiol (EE)/norgestimate, a weak cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of lomitapide and 2 primary metabolites, M1 and M3.

Detailed description:
This study will be a single center, randomized, open-label, 2 arm study to evaluate the effects of EE/norgestimate, a weak CYP3A4 inhibitor, on the PK of lomitapide in healthy female subjects when EE/norgestimate is administered simultaneously with lomitapide and when administration is separated by 12 hours.

Arms: arm 1: Lomitapide \& EE/Norgestimate - Taken Together 2 single oral doses of lomitapide (20 mg) (Day 1 \& Day 22) 21 single oral doses of EE/Norgestimate(Day 8 through day 28) arm 2: Lomitapide \& EE/Norgestimate - Taken 12 hours apart 2 single oral doses of lomitapide (20 mg) (Day 1 \& Day 22) 21 single oral doses of EE/Norgestimate(Day 9 through day 29)
Interventions: intervention 1: lomitapide intervention 2: EE/norgestimate
Intervention descriptions: intervention 1: 20 mg intervention 2: 1x0.035-mg EE/0.25-mg norgestimate tablet

Protocol documents:
Clinical trial NCT00496756
Conditions: Kidney Cancer
Keywords: clear cell renal cell carcinoma stage III renal cell cancer stage IV renal cell cancer recurrent renal cell cancer
Sponsor: University of Nebraska
Start date: 2007-03-01; Completion date: 2014-04-25
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying the side effects and how well sorafenib works in treating patients with metastatic or unresectable kidney cancer.

Detailed description:
OBJECTIVES:

Primary

* Evaluate the safety and toxicity of dose escalating sorafenib tosylate in patients with metastatic or unresectable renal cell carcinoma.

Secondary

* Determine tumor response in these patients.
* Determine time to progression in these patients.
* Determine overall survival of these patients.

Tertiary

* Collect data on angiogenesis inhibition induced by sorafenib tosylate.
* Collect data on immunomodulatory effects of sorafenib tosylate.

OUTLINE: This is an open-label study.

Patients receive oral sorafenib tosylate twice daily on days 1-28. Treatment repeats every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients receive escalating doses of sorafenib tosylate (in the absence of grade 3 or 4 dose-limiting toxicity) until a pre-determined dose is reached.

Blood and urine samples are collected at baseline and periodically during study for VEGF level determination. Blood samples are analyzed for T4/T8, NK, CD25+, and Fox p3 by flow cytometry. Tumor tissue blocks or unstained slides are obtained for chemistry staining of VEGF.

Arms: arm 1: The initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily. Intrapatient dose escalation will occur as defined in the table below, providing no dose limiting toxicity (Grade 3 or 4) is observed. If grade 3 or 4 toxicity is observed, delay and dose modification will occur as defined in protocol. Once dose level 3 is reached, the patient will remain at that dose as defined in following section.

Dose Level 1 Day 1-28 400 mg b.i.d. Dose Level 2 Day 29-56 600 mg b.i.d. Dose Level 3 Day 57- 800 mg b.i.d.

A treatment cycle will be 4 weeks.

Two 4-week cycles will be administered. At the completion of two cycles (week 8), restaging will occur. Patients will continue on therapy per study protocol.
Interventions: intervention 1: Sorafenib
Intervention descriptions: intervention 1: initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily.Intrapatient dose escalation will occur providing no dose limiting toxicity (Grade 3 or 4) is observed. Dose level 2 600mg. Dose level 2 800mg

Protocol documents:
Clinical trial NCT01183221
Conditions: Autism ASD
Sponsor: Alexander Kolevzon
Start date: 2010-06-18; Completion date: 2014-04-25
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study examines the effects of a single dose of intranasal oxytocin (vs. placebo) on complex social cognition in adults with autism spectrum disorders.

Detailed description:
Participants receive a one-time administration of 24-IU intranasal oxytocin (or placebo) and perform an empathic accuracy task, a novel and ecologically valid measure of complex social cognition, in conjunction with functional magnetic resonance imaging (fMRI). The investigators will investigate the effects of oxytocin (versus placebo) on the behavioral and neural correlates of empathic accuracy.

Arms: arm 1: 24IU intranasal oxytocin, minimum of 3 weeks off, then placebo arm 2: Placebo, minimum of 3 weeks off, then 24IU intranasal oxytocin or placebo
Interventions: intervention 1: Syntocinon intervention 2: Placebo
Intervention descriptions: intervention 1: One dose of 24 IU (3 sprays/nostril) intervention 2: Intranasal Placebo

Protocol documents: