ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01657253
Conditions: Dry Eye
Sponsor: Laboratorios Sophia S.A de C.V.
Start date: 2013-11-01; Completion date: 2015-04-01
Enrollment: 183 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-148 in the ocular surface of patients with mild to moderate dry eye compared with ophthalmic solution Systane®

Detailed description:
Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. Current treatment is heavily weighted toward supplementation, stimulation, or preservation of aqueous tears. Artificial tears are one of the primary treatments for dry eye; it is mainly palliative and focuses on reducing the symptoms of discomfort to improve quality of life for a patient.

A phase III randomized double-blind clinical trial will be conducted to evaluate efficacy and safety of the ophthalmic solution PRO-148 in the ocular surface of patients with mild to moderate dry eye compared with ophthalmic solution Systane®. Patients will be randomized to receive one of the treatments for 60 days. Efficacy and safety measures will be performed at baseline and at 60 days after treatment

Arms: arm 1: PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution

doses: 1 drop in each eye, quarter in day arm 2: Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar

doses: 1 drop in each eye, quarter in day
Interventions: intervention 1: PRO-148 intervention 2: Systane
Intervention descriptions: intervention 1: Instill 1 drop in each eye four times a day, for 60 days intervention 2: Instill 1 drop in each eye four times a day, for 60 days

Protocol documents:
Clinical trial NCT01657266
Conditions: Cataract Phacoemulsification Cataract Surgery
Keywords: bromfenac nepafenac cataract phacoemulsification cataract surgery
Sponsor: Laboratorios Sophia S.A de C.V.
Start date: 2013-12-01; Completion date: 2015-04-01
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-155 in patients post phacoemulsification.

Detailed description:
Postsurgical inflammation is an inevitable condition after cataract surgery. The use of non-steroidal anti-inflammatory drugs is a safe option for treating ocular inflammation.

This is a phase II randomized double-blind clinical trial. The aim is to compare and to evaluate efficacy and safety of two ophthalmic solutions in patients post phacoemulsification. Patients will be randomized to receive either PRO-155 or Nevanac for 60 days.

Arms: arm 1: Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye

Maintenance therapy: 1 drop 3 times a day for 30 days arm 2: Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension

Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye

Maintenance therapy: 1 drop 3 times a day for 30 days
Interventions: intervention 1: PRO-155 intervention 2: Nevanac
Intervention descriptions: intervention 1: Pre-medication (before surgery) and maintenance treatment. intervention 2: Pre-medication (before surgery) and maintenance treatment.

Protocol documents:
Clinical trial NCT01659320
Conditions: Depression
Sponsor: Weill Medical College of Cornell University
Start date: 2012-03-01; Completion date: 2015-04-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study will examine whether elderly depressed patients whose depressive symptoms do not respond satisfactorily to therapy with a mood stabilizer or antidepressant alone gain any benefit from taking minocycline alone or in addition to their antidepressant or mood stabilizer medication. Minocycline is a commonly used antibiotic medication with anti-inflammatory properties. It is hoped that information gained from this study will help the investigators better understand the role of inflammation in depression, and whether decreasing inflammation will lead to improvement in the symptoms of depression and cognitive function.

Detailed description:
This research study will examine whether elderly depressed patients whose depressive symptoms do not respond satisfactorily to antidepressant therapy alone gain any benefit from taking minocycline alone or in addition to their antidepressants. Minocycline is a commonly used antibiotic medication with anti-inflammatory properties. It is hoped that information gained from this study will help the investigators better understand the role of inflammation in depression, and whether decreasing inflammation will lead to improvement in the symptoms of depression and cognitive function. Elderly patients with depression who remain symptomatic after at least 6 weeks of treatment with an antidepressant medication reaching a therapeutic dosage will be recruited and receive minocycline augmentation for 8 weeks. They may or may not remain on their antidepressants based on their physicians' clinical recommendation. Response to treatment will be measured weekly during the first four weeks and every other week thereafter using rating scales of depressive symptoms, intellectual functions and side effects.

Arms: arm 1: Open label treatment using minocycline.
Interventions: intervention 1: Minocycline
Intervention descriptions: intervention 1: Minocycline 100 mg twice daily for 8 weeks

Protocol documents:
Clinical trial NCT01666912
Conditions: Adolescence Contraception Postpartum
Keywords: adolescence contraception postpartum rapid repeat pregnancy
Sponsor: University of North Carolina, Chapel Hill
Start date: 2012-08-01; Completion date: 2015-04-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective study comparing two groups of 48 adolescent women each. The intervention group will receive a contraceptive implant postpartum, prior to discharge from the hospital. The control group will receive a contraceptive implant at the usual 6 week postpartum clinic visit. During prenatal care, participants will be consented and screened for enrollment. After delivery, these women will be assessed and consented for enrollment into the study. Women who consent for enrollment will be randomized. Women will be followed up at 3 months, 6 months, 9 months, and 1 year after contraceptive implant insertion. At each follow up, women will be assessed for continuation of and satisfaction with this method of contraception.

Detailed description:

Arms: arm 1: randomized to receive contraceptive implant at normal 6 week postpartum visit arm 2: randomized to receive contraceptive implant prior to leaving the hospital postpartum
Interventions: intervention 1: Contraceptive implant
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01692301
Conditions: Hypertension
Keywords: hypertension, elderly, central aortic pulse pressure, central pulse pressure, pulse wave velocity
Sponsor: Novartis Pharmaceuticals
Start date: 2012-12-01; Completion date: 2015-04-01
Enrollment: 454 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study examined the efficacy of LCZ696 in comparison to the ARB olmesartan on Central Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial stiffness in elderly patients with an elevated systolic blood pressure (SBP) and widened pulse pressure (PP).

Detailed description:

Arms: arm 1: Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study. arm 2: Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
Interventions: intervention 1: LCZ696 intervention 2: Olmesartan intervention 3: LCZ696 matching placebo intervention 4: Olmesartan matching placebo intervention 5: amlodipine intervention 6: hydrochlorothiazide
Intervention descriptions: intervention 1: 200 mg tablet intervention 2: 20 mg and 40 mg capsules intervention 3: LCZ696 Matching Placebo tablet intervention 4: Olmesartan matching placebo capsule intervention 5: amlodipine 2.5 mg or 5 mg tablets intervention 6: hydrochlorothiazide 6.25mg, 12.5mg, or 25 mg tablets

Protocol documents:
Clinical trial NCT01700192
Conditions: Rhinitis, Allergic, Perennial Rhinitis, Allergic, Nonseasonal
Sponsor: ALK-Abelló A/S
Start date: 2013-01-01; Completion date: 2015-04-01
Enrollment: 1482 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of MK-8237 (SCH 900237) in the treatment of House Dust Mite (HDM)-Induced Allergic Rhinitis/Rhinoconjunctivitis (AR/ARC) in children and adults.

The primary hypothesis of this study is that administration of MK-8237, compared to placebo, results in significant reduction in the average total combined rhinitis score (TCRS).

Detailed description:

Arms: arm 1: MK-8237 12 Development Units (DU) rapidly dissolving tablets administered sublingually once daily (q.d.). arm 2: Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.
Interventions: intervention 1: MK-8237 tablets intervention 2: Placebo tablets intervention 3: Rescue Medication: Self-Injectable Epinephrine intervention 4: Rescue Medication: Loratadine tablets intervention 5: Rescue Medication: Olopatadine ophthalmic drops intervention 6: Rescue Medication: Mometasone furoate nasal spray
Intervention descriptions: intervention 1: MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. intervention 2: Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. intervention 3: Self-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication. intervention 4: Loratadine tablet 10 mg administered orally as needed for rescue medication. intervention 5: Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication. intervention 6: Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.

Protocol documents:
Clinical trial NCT01701037
Conditions: Recurrent Melanoma Stage IIB Melanoma (Locally Advanced) Stage IIC Melanoma (Locally Advanced) Stage IIIA Melanoma Stage IIIB Melanoma Stage IIIC Melanoma Stage IV Melanoma (Limited, Resectable)
Keywords: Melanoma, B-RAF, biomarkers, targeted therapy, resistance
Sponsor: Vanderbilt-Ingram Cancer Center
Start date: 2013-01-01; Completion date: 2015-04-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well giving dabrafenib alone and in combination with trametinib before surgery works in treating patients with advanced melanoma that can be removed by surgery. Studying samples of tumor tissue in the laboratory from patients receiving dabrafenib and trametinib may help doctors learn more about the effects of these drugs on cells and help identify biomarkers that determine which patients will respond to these drugs best.

Detailed description:
PRIMARY OBJECTIVES:

I. To identify markers of intrinsic resistance to v-Raf murine sarcoma viral oncogene homolog B1 (B-RAF) targeted therapy in B-RAF mutation-positive melanoma.

SECONDARY OBJECTIVES:

I. To determine if intrinsic resistance can be reversed by mitogen activated protein kinase (MEK) targeted therapy and to identify biomarkers that correlate with this response.

II. To evaluate the feasibility of pre-surgical targeted therapy and serial tumor biopsies in patients with advanced, operable melanoma to determine if this model can be used to evaluate novel combinations of molecular targeted therapy in the future.

TERTIARY OBJECTIVES:

I. To determine if pre-surgical B-RAF and MEK targeted therapy is active and well tolerated in patients with advanced, operable melanoma. These findings may be used to support clinical trials in un-resectable, B-RAF mutation-positive melanoma.

OUTLINE:

Patients receive dabrafenib orally (PO) twice daily (BID) on days 1-28 adding trametinib on days 15-28 followed by surgery on days 28-30. Treatment continues until the day prior to surgery in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed up for 3 months.

Arms: arm 1: Patients receive dabrafenib PO BID on days 1-28 adding trametinib on days 15-28 followed by surgery on days 28-30. Treatment continues in the absence of unacceptable toxicity.
Interventions: intervention 1: dabrafenib intervention 2: trametinib intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: 150 mg given PO intervention 2: 2 mg given PO intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01701063
Conditions: Hepatitis C
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2013-01-01; Completion date: 2015-04-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a carefully monitored cohort of pediatric subjects infected with hepatitis C virus (HCV) on a telaprevir-based regimen in Part A and with dose adjustments if needed before Part B.

Detailed description:

Arms: arm 1: telaprevir + Peginterferon alfa-2b + Ribavirin
Interventions: intervention 1: Telaprevir intervention 2: Peginterferon alfa-2b intervention 3: Ribavirin
Intervention descriptions: intervention 1: 100- and 250-mg chewable tablets or 375-mg film-coated tablets for oral administration intervention 2: 50 μg/0.5 mL, 80 μg/0.5 mL, 120 μg/0.5 mL, or 150 μg/0.5 mL for subcutaneous (SC) injection intervention 3: 200-mg capsules or 40-mg/mL solution for oral administration

Protocol documents:
Clinical trial NCT01703702
Conditions: Alzheimer's Disease
Sponsor: Avid Radiopharmaceuticals
Start date: 2012-10-01; Completion date: 2015-04-01
Enrollment: 641 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to determine the effectiveness of florbetapir (18F) in changing patient management and to evaluate the association between scan status and cognitive decline.

Detailed description:

Arms: arm 1: Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results. arm 2: Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
Interventions: intervention 1: florbetapir (18F)
Intervention descriptions: intervention 1: Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration

Protocol documents:
Clinical trial NCT01713621
Conditions: Malaria
Keywords: P. falciparum malaria
Sponsor: Medicines for Malaria Venture
Start date: 2013-03-01; Completion date: 2015-04-01
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study aims to investigate the concentration dependent effects of OZ439 on the clearance of P. falciparum parasites in patients, specifically the determination of an in-vivo minimum inhibitory concentration (MIC) of OZ439. Characterisation of PK-PD (Pharmacokinetic-Pharmacodynamic) relationships is essential for rational evidence based dosing. The adaptive investigation of a range of doses will provide the best chance of accurate PK-PD characterisation, allowing the observation of Plasmodium falciparum growth dynamics and the subsequent identification of MIC and MPC (minimum parasiticidal concentration). Additionally the tolerability and pharmacokinetics of OZ439 will be confirmed. The PK/PD relationship between OZ439 exposure and subsequent effects on parasitaemia will be investigated.

Detailed description:

Arms: arm 1: Single dose of 100mg of OZ439 administered as an oral suspension arm 2: Single dose of 500mg of OZ439 administered as an oral suspension
Interventions: intervention 1: OZ439
Intervention descriptions: intervention 1: OZ439 is a novel synthetic trioxolane antimalarial agent

Protocol documents:
Clinical trial NCT01720797
Conditions: Malocclusion
Keywords: Malocclusion Accelerated tooth movement Braces Orthodontic treatment Propel
Sponsor: University of Florida
Start date: 2013-02-01; Completion date: 2015-04-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to assess the clinical effectiveness of the procedure of a minimally invasive alveolar microperforation procedure to achieve accelerated tooth movement in patients undergoing orthodontic treatment. "Accelerated tooth movement" means that using the PROPEL™ device may help complete your treatment with braces on one side of your mouth sooner than would be expected if the device were not to be used.

Detailed description:
Following informed consent and satisfying the screening/enrollment assessments, a panoramic and periapical radiograph of the teeth designated for micro-osteoperforation treatment is to be taken. Prior to the intervention the subjects will swish 5cc of chlorhexidine for one minute, twice. Micro-osteoperforation, PROPEL™, is conducted under local or topical anesthesia AFTER the subject is banded and bonded. The procedure will be randomized to either the left or right side in each subject. Following the procedure, Chlorhexidine rinses are to begin twice a day for a week.

The subjects will be advised to take Tylenol only in case of significant pain. Subjects will be seen four to six weeks after completion of treatment for the first follow-up. Subjects will be followed up with a telephone consult 24 hours after micro-osteoperforation is performed. They will be asked if any pain medication was taken after being dismissed from the research center and if so, they will be asked the name and dose of medication taken.

Study will conclude at the 6 month follow up visit or when space on the treating side is closed.

Arms: arm 1: Minimally invasive micro-osteoperforation (PROPEL™) procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week. arm 2: Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.
Interventions: intervention 1: Micro-osteoperforation intervention 2: Anesthestic intervention 3: Chlorhexidine
Intervention descriptions: intervention 1: Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement. intervention 2: Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. intervention 3: Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice. Following procedure Chlorhexidine rinses are to begin twice a day for a week.

Protocol documents:
Clinical trial NCT01741259
Conditions: Cesarean Section
Keywords: analgesia meperidine epidural
Sponsor: Mercy Research
Start date: 2013-08-01; Completion date: 2015-04-01
Enrollment: 273 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if epidural meperidine administered by patient-controlled bolus button is equivalent to a low dose infusion plus patient-controlled bolus.

Detailed description:
The objective of this study is to compare the efficacy, patient satisfaction, and incidence of side effects of meperidine patient-controlled epidural analgesia (PCEA) with and without a basal infusion for post-cesarean section analgesia.

Arms: arm 1: Epidural Meperidine (5mg/ml) bolus of 20 mg, lockout of 30 min, hourly limit of 50 mg. arm 2: Epidural meperidine (5mg/ml) basal rate of 10 mg/hr, bolus 20 mg, lockout 30 min, hourly limit 40 mg
Interventions: intervention 1: Meperidine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01763996
Conditions: Coronary Artery Disease
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2013-05-01; Completion date: 2015-04-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the effect of febuxostat on coronary artery flow in patients with coronary artery disease.

Detailed description:
The drug being tested in this study is called febuxostat. Febuxostat is being tested to treat people who have angina. This study will look at the heart and blood flow of people who take febuxostat.

The study will enroll approximately 30 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups (or sequences)-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* Sequence 1: 6 weeks febuxostat followed by 6 weeks of placebo.
* Sequence 2: 6 week placebo followed by 6 weeks of febuxostat

All participants will be asked to take one capsule at the same time each day throughout the study. All participants will be asked to record any time they have angina symptoms during the study.

This single-center trial will be conducted in the United States. The overall time to participate in this study is 16 weeks. Participants will make 7 visits to the clinic including a final visit 4 weeks after last dose of study drug for a follow-up assessment.

Arms: arm 1: Febuxostat 80 mg, capsules, orally, once daily for 6 weeks in Period 1, followed by febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 2. arm 2: Febuxostat placebo-matching capsules, orally, once daily for 6 weeks in Period 1, followed by febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 2.
Interventions: intervention 1: Febuxostat intervention 2: Febuxostat placebo
Intervention descriptions: intervention 1: Febuxostat capsules intervention 2: Febuxostat placebo-matching capsules

Protocol documents: