ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01490086
Conditions: Acute Schizophrenia Schizoaffective Disorder
Sponsor: Reviva Pharmaceuticals
Start date: 2011-12-01; Completion date: 2013-03-01
Enrollment: 234 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the efficacy and safety of RP5063 relative to placebo for the treatment of schizophrenia or schizoaffective disorder.

Detailed description:

Arms: arm 1: RP5063 15 mg once daily arm 2: RP5063 30 mg once daily arm 3: RP5063 50 mg once daily arm 4: Placebo once daily arm 5: aripiprazole 15 mg daily
Interventions: intervention 1: RP5063 intervention 2: placebo intervention 3: aripiprazole
Intervention descriptions: intervention 1: daily intervention 2: daily intervention 3: daily

Protocol documents:
Clinical trial NCT01495221
Conditions: AMD (With Persistent or Recurrent Fluid Despite Monthly Intravitreal Anti-VEGF Therapy)
Sponsor: Vitreous -Retina- Macula Consultants of New York
Start date: 2011-12-01; Completion date: 2013-03-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label study to evaluate intravitreally administered 2.0 mg intravitreal aflibercept injection in patients who have been previously treated for AMD and have persistent or recurrent fluid despite monthly intravitreal anti-VEGF therapy.

Detailed description:

Arms: arm 1: All eligible patients will receive intravitreal aflibercept injection (2.0mg) every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months) through Week 24. Patients can be dosed as frequently as 2 mg every 4 weeks (monthly) upon investigator discretion.
Interventions: intervention 1: Alfilbercept
Intervention descriptions: intervention 1: All patients will receive 2.0 mg intravitreal aflibercept injection.

Protocol documents:
Clinical trial NCT01498068
Conditions: Genotype 1 Chronic Hepatitis C
Keywords: Genotype 1 chronic Hepatitis C VX-950HPC3007 VX-950 Hepatitis C Telaprevir HCV
Sponsor: Janssen-Cilag International NV
Start date: 2012-01-01; Completion date: 2013-03-01
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the effectiveness, safety and tolerability of telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in treatment-naïve and treatment-experienced Russian participants with genotype 1 chronic hepatitis C.

Detailed description:
This is an open-label (all persons know the study drug assignment), multicenter study in treatment-naïve (participant did not receive any previous treatment for the treatment of hepatitis C) and treatment-experienced (participant did receive previous treatment for hepatitis C) Russian participants with genotype 1 chronic hepatitis C. After a screening period of approximately 4 weeks, participants will be treated for 12 weeks with telaprevir 750 mg every 8 hours in combination with Peg-IFN-alfa-2a and RBV followed by 12 or 36 weeks of treatment with Peg-IFN-alfa-2a and RBV alone depending on their liver disease status, response to previous treatment and individual virologic response during treatment in this study. After the treatment period, there is a follow-up phase of at least 12 weeks.

Arms: arm 1: Treatment naïve participants will receive telaprevir 750 mg 8 hourly for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram weekly and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration will be based on participant's prior treatment status, liver disease status, and individual ontreatment virologic response in this study. arm 2: Treatment-experienced participants received telaprevir 750 mg 8 hourly for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram weekly and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration will be based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
Interventions: intervention 1: Telaprevir intervention 2: Pegylated-interferon-alfa-2a intervention 3: Ribavirin
Intervention descriptions: intervention 1: Telaprevir Type = exact number, unit = mg, number = 750, form = tablet, route = oral. Telaprevir 750 mg (2 oral tablets) is taken every 8 hours for 12 weeks intervention 2: Pegylated-interferon-alfa-2a type = exact number, unit = microgram, number = 180, form = injection, route = subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks intervention 3: Ribavirin Type = exact, number = 1000 or 1200, unit = mg, form = tablet, route = oral. 1000mg (if participant's weight is \< 75kg) or 1200mg (if participant's weight is \>= 75kg) per day for 24 or 48 weeks.

Protocol documents:
Clinical trial NCT01508832
Conditions: Onset and Duration of a Digital Nerve Block
Sponsor: University of California, San Francisco
Start date: 2012-01-01; Completion date: 2013-03-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The duration of the autonomic (sympathetic) block will last longer than the sensory block. The duration of the increased perfusion index will last longer than either the sympathetic or sensory block.

Detailed description:
The Masimo SpHb™ (SpHb) is a device used to monitor the blood hemoglobin level via a sticky sensor connected to a finger. Our results from 2 recent studies undertaken with this device concluded: 1) that it is not always accurate when the finger is cold such as during surgical blood loss, and 2) a local nerve block to the finger improved the finger temperature and the accuracy of the device.

Our purpose is to investigate the duration of effect of two local nerve blocking drugs (lidocaine and bupivacaine - both FDA approved drugs in routine use) in a finger on each hand. Having a better understanding of how long the nerve block lasts could help determine when an additional block might be necessary to maintain the accuracy of the device during surgical blood loss.

We previously listed the primary outcome for this study as the time until return to baseline finger temperature. However, in blinded looks at the data it became clear that defining time until return to baseline from the serial temperature measurements in an objective fashion would be extremely difficult and potentially controversial. We have modified the primary outcome to be the change in the average temperature from baseline to post-intervention.

Arms: arm 1: Lidocaine 1% Digital Nerve Block (2 cc) arm 2: Bupivacaine 0.25% Digital Block (2 cc)
Interventions: intervention 1: Lidocaine Digital Nerve Block intervention 2: Bupivacaine Digital Block
Intervention descriptions: intervention 1: Lidocaine 1% Digital Nerve Block (2 cc intervention 2: Bupivacaine 0.25% Digital Block (2 cc)

Protocol documents:
Clinical trial NCT01510912
Conditions: Osteoarthritis
Sponsor: Iroko Pharmaceuticals, LLC
Start date: 2012-01-01; Completion date: 2013-03-01
Enrollment: 602 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety of Diclofenac \[Test\] Capsules for the treatment of osteoarthritis pain of the knee or hip.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Diclofenac
Intervention descriptions: intervention 1: 35 mg bid or tid Capsules

Protocol documents:
Clinical trial NCT01514149
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: Type 2 Diabetes Mellitus T2DM diabetes ConjuChem GLP-1 Glucagon-like peptide-1 exendin-4 modified exendin-4
Sponsor: ConjuChem
Start date: 2011-09-01; Completion date: 2013-03-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus on metformin monotherapy.

Detailed description:
DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus (T2DM) on metformin monotherapy. This study will be a randomized, double-blind comparison of CJC-1134-PC versus placebo. Patients taking metformin will continue to take their metformin at the same dose for the duration of the study.

Patients with T2DM, who meet all the inclusion criteria and none of the exclusion criteria, will be randomly assigned to a treatment arm. All patients will undergo weekly clinic visits to receive 17 weeks of study treatment, including the titration period.

CJC-1134-PC or placebo treatment will be administered weekly by subcutaneous injection in the abdomen to patients in a fasting state. Patients will be closely monitored and evaluated for toxicity on an ongoing basis.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: CJC-1134-PC Injection intervention 2: Weekly placebo for CJC-1134-PC Injection
Intervention descriptions: intervention 1: CJC-1134-PC administered weekly by subcutaneous injection intervention 2: Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection

Protocol documents:
Clinical trial NCT01532414
Conditions: Secondary Hypogonadism
Sponsor: Repros Therapeutics Inc.
Start date: 2012-08-01; Completion date: 2013-03-01
Enrollment: 151 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of ZA-301 is to determine the effects of Androxal on morning testosterone and reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T\<300 ng/dL) and normal sperm concentration, compared to changes with placebo. Subjects must not have previously been treated with testosterone products within the last 6 months.

Detailed description:
Protocol ZA-301 is a randomized, double-blind, placebo-controlled multi-center Phase 3 study to evaluate normalization of morning testosterone levels in overweight men with acquired hypogonadotropic hypogonadism and normal baseline sperm concentrations. The study requires 10 to 12 clinic visits (2 for eye exams), and is approximately 4 to 5½ months in duration. Subjects will be treated for 12-18 weeks. At Visit 3 (Week 6) subjects who do not achieve morning T values ≥300 ng/dL will be up-titrated to 25 mg. Placebo subjects may be sham titrated. Up-titrated subjects will receive an additional 6 weeks of treatment (18 weeks total). A schedule of procedures and assessments is displayed in Section 4. The study will enroll up to 152 male subjects, up to 114 randomized to treatment with Androxal and up to 38 randomized to placebo, in a 3:1 ratio. Subjects must not have used any prior testosterone treatments within the last 6 months.

Eligible subjects must have 2 consecutive assessments of morning T below 300 ng/dL and LH below 9.4 mIU/mL. They will provide 2 sperm samples at baseline, at least 2 days apart, another 2 after 12 weeks of treatment, and up-titrated subjects will provide an additional 2 samples at the end of treatment. After 12 weeks of treatment (V5) all subjects will undergo serial T assessment for determination of the Cavg. Safety assessments will include collection of adverse events, eye examinations, physical examinations and clinical laboratory assessments.

Arms: arm 1: Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily arm 2: Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily arm 3: Placebo oral capsules taken one time daily
Interventions: intervention 1: Androxal intervention 2: Placebo
Intervention descriptions: intervention 1: oral, capsules, taken one time daily, for 3 months intervention 2: Oral capsule taken one time daily for 3 months

Protocol documents:
Clinical trial NCT01554163
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis Celecoxib Etoricoxib
Sponsor: Organon and Co
Start date: 2012-03-01; Completion date: 2013-03-01
Enrollment: 239 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to establish that etoricoxib 30 mg is safe and not inferior to celecoxib 200 mg in the treatment of the signs and symptoms of osteoarthritis in Korean patients. Given that the efficacy of etoricoxib vs. placebo in the treatment of osteoarthritis has been established, and that prescription drugs, such as celecoxib, are available for the treatment of pain associated with osteoarthritis in Korea, it would be inappropriate to subject patients with a flare of osteoarthritic pain to the placebo treatment for 12 weeks, and thus the study is designed as an active-comparator study.

Detailed description:

Arms: arm 1: Etoricoxib, 30 mg tablet, orally, once daily for 12 weeks. arm 2: Celecoxib, 200 mg capsule, orally, once daily for 12 weeks.
Interventions: intervention 1: Etoricoxib 30 mg intervention 2: Celecoxib 200 mg
Intervention descriptions: intervention 1: Etoricoxib 30 mg tablet once daily for 12 weeks. intervention 2: Celecoxib 200 mg once daily for 12 weeks

Protocol documents:
Clinical trial NCT01558128
Conditions: Cardiac Disease
Sponsor: Weill Medical College of Cornell University
Start date: 2012-03-01; Completion date: 2013-03-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the efficacy of cardioversion and amiodarone for cardiac patients who develop postoperative atrial fibrillation

Detailed description:
New-onset atrial fibrillation (AF) after cardiac surgery is a well-recognized phenomenon with significant outcome implications. Incidence after coronary artery bypass grafting (CABG) is estimated at 26-33%, while those undergoing valvular surgery bear a greater burden at 33-49%. Clinical and socioeconomic complications resulting from postoperative atrial fibrillation include an increased risk of death (10%), congestive heart failure (4%), prolonged hospital stays, and increased rate of discharge to care facilities over those who remain in sinus rhythm, (7%). Although a body of evidence exists for electrical or pharmacological cardioversion to sinus rhythm postoperatively, there is a marked paucity in the literature regarding efficacy and outcomes combining the two. More specifically, we seek to evaluate the efficacy of DC cardioversion when combined with amiodarone. Improved outcomes with multimodal cardioversion may decrease the postoperative clinical burden of atrial fibrillation on cardiac surgery patients.

Arms: arm 1: If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.
Interventions: intervention 1: Amiodarone intervention 2: Cardioversion
Intervention descriptions: intervention 1: Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours. intervention 2: Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol.

Protocol documents:
Clinical trial NCT01567852
Conditions: Post-anesthesia Recovery Orientation
Keywords: orientation post-anesthesia recovery electroconvulsive therapy
Sponsor: University of New Mexico
Start date: 2011-08-01; Completion date: 2013-03-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
When undergoing ECT treatments, patient recovery time and re-orientation time may be shorter using ketamine for induction than using methohexital.

Detailed description:
ECT treatments are done under general anesthesia, and the induction is commonly done with methohexital. We will study whether using ketamine as an induction agent will result in a faster recovery time and quicker re-orientation time compared to using methohexital.

Arms: arm 1: This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine arm 2: This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital.
Interventions: intervention 1: Ketamine intervention 2: Methohexital
Intervention descriptions: intervention 1: Ketamine (1.5mg/kg) will be given for induction, with room to titrate up to induction effect intervention 2: Methohexital (1.5mg/kg) will be given for induction

Protocol documents:
Clinical trial NCT01578772
Conditions: Endothelial Dysfunction
Keywords: HIV Flow-mediated dialation (FMD) Telmisartan Cardiovascular disease (CVD) HIV+ men and women age > 50 at risk for heart disease
Sponsor: University of California, Los Angeles
Start date: 2012-08-01; Completion date: 2013-03-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study is to see whether blood vessel function, an early sign of heart disease, improves in HIV-infected men and women who take telmisartan for 12 weeks. The investigators will be looking at how a blood vessel in the arm, called the brachial artery, changes in response to stress before and after taking telmisartan. To determine how well the blood vessel functions, the investigators will be using an ultrasound machine.

Telmisartan is not an HIV medication. It is an FDA-approved medication designed to treat blood pressure, but has been shown to improve blood vessel function in HIV-negative people with and without high blood pressure. Telmisartan is made by Boehringer Ingelheim, and this trial is sponsored by The Campbell Foundation.

Detailed description:

Arms: arm 1: Open label
Interventions: intervention 1: Telmisartan
Intervention descriptions: intervention 1: 80mg tablets po daily for 6 weeks

Protocol documents:
Clinical trial NCT01579578
Conditions: Metastatic, Gastric or Gastro-oesophageal Junction, Cancer
Keywords: Metastatic Gastric Cancer who progress following First Line Therapy and are Ineligible for Treatment with trastuzumab by HER2 Status
Sponsor: AstraZeneca
Start date: 2012-04-01; Completion date: 2013-03-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the efficacy and safety and PK of AZD8931 plus paclitaxel versus paclitaxel alone in patients with metastatic, gastric or gastro-oesophageal junction, cancer.

Detailed description:
A Phase IIa Multi-centre Randomised Double-Blind Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of AZD8931 in Combination with Paclitaxel versus Paclitaxel alone in Patients with Metastatic, Gastric or Gastro-oesophageal Junction, Cancer who progress following First Line Therapy and are Ineligible for Treatment with trastuzumab by HER2 Status (SAGE)

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AZD8931 intervention 2: Placebo intervention 3: Paclitaxel
Intervention descriptions: intervention 1: 40 mg, oral dose twice daily intervention 2: Placebo, oral dose twice daily intervention 3: IV once weekly for 3 weeks followed by a week off.

Protocol documents:
Clinical trial NCT01580423
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: dyspnea
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2012-04-01; Completion date: 2013-03-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Substance P is released from sensory nerves and transmits pain information into the central nervous system. As pain and dyspnea share many characteristics, including similar neurological pathways, it is possible that substance P may contribute to the sensation of dyspnea. The hypothesis of the study is that patients with chronic obstructive pulmonary disease (COPD) will provide lower ratings of breathlessness during resistive load breathing with oral aprepitant, a medication that blocks the activity of substance P, compared with placebo.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: aprepitant intervention 2: placebo
Intervention descriptions: intervention 1: 125 mg capsule intervention 2: capsule identical to aprepitant

Protocol documents:
Clinical trial NCT01593787
Conditions: Hypertension With Renal Dysfunction
Keywords: Hypertension Renal dysfunction LCZ696
Sponsor: Novartis Pharmaceuticals
Start date: 2012-05-01; Completion date: 2013-03-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients with renal dysfunction.

Detailed description:

Arms: arm 1: All participants were started on LCZ696 100 mg once daily on day 1. arm 2: All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP \<80 mmHg and msSBP \<130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg. arm 3: All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP \<80 mmHg and msSBP \<130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
Interventions: intervention 1: LCZ696
Intervention descriptions: intervention 1: 100 mg, 200 mg, 400 mg tablets.

Protocol documents:
Clinical trial NCT01602471
Conditions: Carotid Stenosis
Keywords: Endarterectomy K5-C200 RGD-K5 angiogenesis Carotid CT Angiogram
Sponsor: Siemens Molecular Imaging
Start date: 2012-05-01; Completion date: 2013-03-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial will be the first trial for the Investigation Product (IP), \[F-18\]RGD-K5 for carotid plaque imaging and will be conducted as a Phase II trial since this compound has already been tested in humans for phase I and phase II imaging. All study results will be evaluated and analyzed in order to consider the design for future clinical trials.

Detailed description:
This investigation will be conducted as a Phase II, open-label, single-center, non-randomized study. The study is planned to be conducted at one Investigative site in the United States. The information collected under this exploratory, Phase II study will not be used for diagnostic purposes, to assess the participant's response to therapy, or for clinical management of the participant. This will be a pilot prospective cohort study where the increased expression of integrin may be seen on the F-18 RGD-K5 PET imaging scans looking at carotid plaque in participants with carotid artery stenosis.

Each completed study participant will undergo one to three visits, including one eligibility study visit, the Computed Tomography (CT) angiogram of the carotid visit (if necessary), the \[F-18\] RGD-K5 PET imaging visit, and a 24 hour follow up phone call or visit.

Procedures: Informed consent (ICF), eligibility blood labs, collection of demographic information and medical history, physical examination, vital signs, 12-lead Electrocardiograms (ECGs), dosing with \[F-18\]RGD-K5, PET imaging scan, 24 hour follow up to collect adverse events, and plaque immunohistochemical characterization after Carotid Endarterectomy (CEA).

Arms: arm 1: \[F-18\]RDG-K5 was administred and PET scan performed
Interventions: intervention 1: [F-18]RDG-K5
Intervention descriptions: intervention 1: Approximately fifteen (15) patients with carotid artery stenosis \> 69% will undergo an endarterectomy and will be imaged under PET/CT with \[F-18\]RGD-K5

Protocol documents: