ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01739595
Conditions: Secondary Hypogonadism
Sponsor: Repros Therapeutics Inc.
Start date: 2012-11-01; Completion date: 2013-09-01
Enrollment: 181 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of ZA-302 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-302 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: enclomiphene citrate 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 NCT01751399
Conditions: Healthy Volunteers Hepatic Insufficiency Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2012-12-01; Completion date: 2013-09-01
Enrollment: 35 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to help answer the following research questions:

* To evaluate how much of the study drug (LY2605541) is in the blood of participants with varying degrees of liver impairment compared to those with normal liver function
* To assess the safety of LY2605541 and any side effects that might be associated with it

Detailed description:
The study is conducted in 4 groups, based on the Child-Pugh classification of hepatic impairment as follows:

Group 1: Participants with normal hepatic function (Control); Group 2: Participants with mild hepatic impairment (Child-Pugh class A); Group 3: Participants with moderate hepatic impairment (Child-Pugh class B); and Group 4: Participants with severe hepatic impairment (Child-Pugh class C).

Arms: arm 1: Participants with normal hepatic function will receive a single subcutaneous (SC) dose of 0.075 milligrams per kilogram (mg/kg) LY2605541 arm 2: Participants with mild hepatic impairment will receive a single SC dose of 0.075 mg/kg LY2605541 arm 3: Participants with moderate hepatic impairment will receive a single SC dose of 0.075 mg/kg LY2605541 arm 4: Participants with severe hepatic impairment will receive a single SC dose of 0.075 mg/kg LY2605541
Interventions: intervention 1: LY2605541
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01819272
Conditions: Type 2 Diabetes Mellitus
Sponsor: Elcelyx Therapeutics, Inc.
Start date: 2013-04-01; Completion date: 2013-09-01
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compared the effect of delayed-release metformin (Met DR) to placebo and extended release metformin (Met XR) on glycemic control (fasting plasma glucose and HbA1c) and body weight, and assessed the safety and tolerability of a range of doses of Met DR when administered in subjects with type 2 diabetes mellitus (T2DM).

Detailed description:

Arms: arm 1: 600 mg delayed-release metformin once daily in the morning arm 2: 800 mg delayed-release metformin once daily in the morning arm 3: 1000 mg delayed-release metformin once daily in the morning arm 4: 1000 mg extended-release metformin once daily in the evening arm 5: 2000 mg extended-release metformin once daily in the evening arm 6: Placebo once daily in the morning
Interventions: intervention 1: Met DR intervention 2: Met XR intervention 3: Placebo
Intervention descriptions: intervention 1: metformin delayed-release tablets intervention 2: metformin extended-release tablets intervention 3: placebo delayed-release tablets

Protocol documents:
Clinical trial NCT01841593
Conditions: HIV
Sponsor: St Stephens Aids Trust
Start date: 2013-04-01; Completion date: 2013-09-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to look at the levels of an HIV medication (raltegravir) in the blood, and how it is affected if raltegravir is taken at the same time as another medicine for high blood pressure (amlodipine). Many patients with HIV will also have high blood pressure, so it is important to know which drugs for each of these conditions can be taken together without affecting how well they work individually.

Over a 3 week period, participants took amlodipine for 2 weeks, and raltegravir for 2 weeks, with the middle week being on both drugs. The investigators will look at and compare the levels of these two drugs in the blood after subjects have taken them separately and both together.

This study is randomised into two groups with both study medications received by all participants in a three-period crossover pattern; randomisation determined which medication was taken first. Once randomised allocation was performed, medications were administered in an open-label fashion.

Detailed description:
HIV-negative male and female volunteers will be enrolled, after written confirmation of informed consent, in a phase I, open-label, cross-over, PK study (approved by Westminster Research Ethics Committee and UK Regulatory Authorities; Eudra number 2012-005400-18).

Subjects are randomized to receive either raltegravir 400mg twice-daily (seven days), followed by raltegravir 400mg twice-daily plus amlodipine 5mg once-daily (seven days), followed by amlodipine 5mg once-daily alone (seven days), or the same treatments in the opposite order, in the fasted state (at least eight hours) with 240mL of water.

Intensive PK sampling and safety laboratory analysis are performed at the end of each phase (Days 7, 14 and 21). Raltegravir and amlodipine plasma concentrations will be analysed by a validated liquid chromatography-mass spectrometry (LC-MS/MS) method.

PK parameters are determined by non-compartmental methods \[WinNonlin Phoenix (version 6.1; Pharsight Corp, Mountain View, CA, USA\]. These are the concentrations measured 12 and 24 hours post-dose (C12h, C24h) for raltegravir and amlodipine, respectively; the maximum concentration (Cmax); and the area under the curve over 12 and 24 hours (AUC12h, AUC24h) for raltegravir and amlodipine, respectively.

Arms: arm 1: DAYS 1 to 7: raltegravir 400 mg BID DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: amlodipine 5 mg OD arm 2: DAYS 1 to 7: amlodipine 5 mg OD DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: raltegravir 400 mg BID
Interventions: intervention 1: Raltegravir intervention 2: Amlodipine
Intervention descriptions: intervention 1: Isentress 400mg tablet taken twice daily intervention 2: generic amlodipine 5mg tablets (Accord healthcare Limited, UK)

Protocol documents:
Clinical trial NCT01857063
Conditions: Seasonal Allergic Rhinitis
Sponsor: Organon and Co
Start date: 2013-06-10; Completion date: 2013-09-01
Enrollment: 220 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate the efficacy and safety of montelukast (MK-0476) in the treatment of Japanese pediatric participants with seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that montelukast is superior to placebo in the treatment of nasal symptoms in SAR.

Detailed description:

Arms: arm 1: Participants receive montelukast 5 mg chewable tablets for 7 days during Period 1 and receive placebo chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2. arm 2: Participants receive placebo chewable tablets for 7 days during Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
Interventions: intervention 1: Montelukast intervention 2: Placebo
Intervention descriptions: intervention 1: Montelukast 5 mg chewable tablets, taken orally once daily at bedtime for 7 days intervention 2: Matching placebo chewable tablets, taken orally once daily at bedtime for 7 days

Protocol documents:
Clinical trial NCT01857323
Conditions: Asthma Chronic Obstructive Pulmonary Disease (COPD)
Keywords: asthma chronic obstructive pulmonary disease COPD Albuterol Spiromax®
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2013-05-01; Completion date: 2013-09-01
Enrollment: 317 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a prospective, open-label, multicenter Phase 3 study evaluating the performance of the Albuterol Spiromax dose counter in patients with a diagnosis of asthma and/or COPD. The purpose of this study is to evaluate the functionality, reliability, and accuracy of the Albuterol Spiromax inhaler integrated dose counter in a clinical setting.

Detailed description:
The study consists of a screening/run-in period where, after meeting study criteria, patients enter a run-in period lasting 7 to 14 ±2 days, during which diary and medication compliance, as well as inhaler technique, will be assessed. The run-in period will commence the day following the completion of all screening procedures and will continue through to and include the day prior to the first treatment visit (TV1) such that a minimum of 7 full days of diary data will be collected prior to TV1. The purpose of the run-in period is to assess compliance with a BID dosing regimen and with the completion of the diary entries over a minimum period of 7 days. Patients who demonstrate adequate inhaler technique and who are at least 90% compliant with dosing and completion of the diary on the last 7 consecutive days of run-in will qualify for enrollment into the open-label study. The study treatment period will comprise 6 treatment visits (TV1-TV6) for all enrolled patients except those in the 5-week treatment cohort who will have only 5 treatment visits (TV1-TV5). Patients may continue taking their current asthma or COPD medications throughout the Treatment Period. The patient will return to the clinic on Days 8 (±1), 15 (±1), 22 (±1), and 36 (±1), and then on Day 50 (-2) after approximately all 200 doses have been delivered, or until early withdrawal. The patient will be deemed to have completed the study if at least 90% of the recommended doses contained in Albuterol Spiromax with dose-counter were used. A representative sample (approximately 15%) of patients will participate in the trial for approximately 5 weeks with Day 36 (±1) being the final study visit.

Arms: arm 1: The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
Interventions: intervention 1: Albuterol Spiromax®
Intervention descriptions: intervention 1: Albuterol Spiromax delivers 90 mcg of albuterol base from the mouthpiece per triggered dose. Participants took doses of 2 inhalations each twice a day (morning and evening) for a total daily dose of 360 mcg. The first 45 enrolled participants constituted a subgroup who were dosed for 35 days, while most participants were dosed for 50 days.

Protocol documents:
Clinical trial NCT01877265
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-06-01; Completion date: 2013-09-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study looks at the amount of LY2605541 in the body after it is injected under the skin. The study has 3 periods, each lasting 10 days. Each participant will receive one injection in each period. At least 14 days will pass between each injection.

Detailed description:

Arms: arm 1: Each healthy participant will receive a single subcutaneous (SC) injection of 0.5 units per kilogram (U/kg) of LY2605541 on Day 1 of 1 of 3 treatment periods arm 2: Each healthy participant will receive single SC injection of 0.5 U/kg of LY2605541 on Day 1 of 1of 3 treatment periods arm 3: Each healthy participant will receive single SC injection of 0.5 U/kg of LY2605541 on Day 1 of 1 of 3 treatment periods
Interventions: intervention 1: LY2605541
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01881737
Conditions: Autistic Disorder
Keywords: autism
Sponsor: Stanford University
Start date: 2011-07-01; Completion date: 2013-09-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the tolerability and effectiveness of pregnenolone in the treatment of behavioral deficits in adults with autism. Pregnenolone is a naturally occurring hormone found in the body which has been shown to help with the function of nerve cells. It is also shown to modulate the activity of certain brain receptors implicated in autism. We hope to examine the tolerability of pregnenolone in adults with autism.

Detailed description:
This study will assess the tolerability and effectiveness of pregnenolone in the treatment of behavioral deficits in adults with autism. Pregnenolone is a naturally occurring hormone found in the body which has been shown to help with the function of nerve cells. It is also shown to modulate the activity of certain brain receptors implicated in autism.

Pregnenolone has been used safely in research studies involving individuals with schizophrenia. In the proposed trial, we hope to examine the tolerability of pregnenolone in adults with autism. We hope to see improvement in behavioral outcomes as measured by standardized behavioral measures. Further, we will measure concentrations of pregnenolone and related neuroactive compounds in the blood. The use of pregnenolone has been studied in a number of mental disorders but not autism. Thus, we hope the study will identify new avenues of research for the treatment of autism.

Arms: arm 1: Pregnenolone up to 500 mg per day
Interventions: intervention 1: Pregnenolone
Intervention descriptions: intervention 1: With Baseline serving as approximately day 1, twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.

Week 1 and 2: 100 mg

Week 3 and 4: 200 mg

Week 5 and 6: 300 mg

Week 7 and 8: 400 mg

Week 9 -12: 500 mg

At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.

If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs.

Protocol documents:
Clinical trial NCT01883440
Conditions: Common Cold
Keywords: Duration
Sponsor: Krister Tano
Start date: 2013-01-01; Completion date: 2013-09-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Glucose oxidase is a hydrogen peroxide producing enzyme, which also is present in honey. Human rhinoviruses are sensitive to the action of hydrogen peroxide, which is documented in laboratory studies.

In the present study we aim to investigate if a nasal spray with glucose oxidase could treat a common cold, when the treatment is started even after the onset of the symptoms. The study is randomized and placebo controlled.

Detailed description:
Persons that are convinced of that they have caught an episode of common cold can be included into the study within 24 hours after the onset of symptoms.

Before they start the treatment with the nasal spray they perform a viral sample from the nose and also fill in the WURSS-21 protocol. After this the persons spray with glucose oxidase+glucose/only saline+glucose 5 times the first day and thereafter 3 times daily for a total treatment of one week. Every day the included persons fill in the WURSS-21 protocol.

Arms: arm 1: A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week arm 2: A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.
Interventions: intervention 1: Glucose oxidase + glucose intervention 2: Saline+glucose
Intervention descriptions: intervention 1: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device intervention 2: Placebo arm

Protocol documents:
Clinical trial NCT01895036
Conditions: Stable Opioid Dependence
Keywords: maintained on 2 mg or less of buprenorphine, in which discontinuation of agonist treatment is clinically feasible but difficult
Sponsor: New York State Psychiatric Institute
Start date: 2011-02-01; Completion date: 2013-09-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The efficacy of buprenorphine as a long-term agonist treatment has been offset by the emergence of intolerable withdrawal phenomena in a subset of individuals on chronic maintenance who attempt to discontinue the medication. Efforts are needed to better understand these challenges encountered with buprenorphine, as well as to develop interventions to facilitate medication discontinuation.

Emerging evidence suggests that these difficulties may be related to the unique effects of buprenorphine on sites other than mu-opioid receptors, such as kappa-opioid receptors. Kappa-opioid agonism produces aversive, dysphoric-like effects, and can also increase the likelihood of reinstatement to drug use through stress-mediated mechanisms. Some of the discomfort observed during drug taper may therefore be due to the attenuation or loss of kappa-opioid antagonism afforded by buprenorphine, as well as to rebound kappa-opioid activation. Naltrexone represents a promising candidate for extending kappa blockade and therefore for facilitating discontinuation attempts. Naltrexone and its active metabolite 6-Beta-naltrexol are competitive antagonists at the mu and kappa receptors, and to a lesser extent at the delta receptor. Naltrexone and buprenorphine have comparable affinity for the mu-opioid receptor and thus buprenorphine is displaced by naltrexone more gradually than are other opioids with less affinity; a careful titration of naltrexone is less likely, therefore, to precipitate severe withdrawal states in individuals coming off buprenorphine, and the two have been combined to good effect in other settings.

The purpose of this study is therefore to investigate the feasibility of naltrexone augmentation on discontinuing buprenorphine in eligible patients on long-term maintenance.

Detailed description:

Arms: arm 1: PO naltrexone titration on a mixed inpatient/outpatient basis, followed by administration of Vivitrol four days following the 1st dose of naltrexone
Interventions: intervention 1: Naltrexone
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01897493
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-07-01; Completion date: 2013-09-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to determine how much digoxin gets into the blood stream and how long it takes the body to get rid of it when given with the study drug evacetrapib. This study will also look at the effect of evacetrapib on the removal of digoxin from the body by the kidneys. Information about any side effects that may occur will be collected. This study will last approximately 33 days for each participant, not including screening.

Detailed description:

Arms: arm 1: 0.5 milligram (mg) digoxin administered orally once daily (QD) on Day 1 arm 2: 130 mg evacetrapib administered orally, QD for 14 days (Days 6 through 19) with a single oral dose of 0.5 mg digoxin coadministered on Day 15
Interventions: intervention 1: Evacetrapib intervention 2: Digoxin
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT01899677
Conditions: Necrotising Enterocolitis
Keywords: Symbiotic,cytokines, necrotising enterocolitis
Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Start date: 2013-07-01; Completion date: 2013-09-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this prospective double blinded randomised study is to investigate the efficacy of symbiotic preparation which contains lactobacillus casei, L. rhamnosus, L. plantarum, Bifidobacterium lactis, fructo and galactooligosaccharide on cytokines as interferon-gama acting on Th1 pathway, interleukin -5 acting on Th2, interleukin -10 acting on T regulatory pathway, and interleukin -17 acting on Th-17 pathway that were related with necrotizing enterocolitis pathogenesis in very low birth weight neonates.

Detailed description:
Inclusion criteria:

1. Neonates who born 26- 32 gestational week and 750-1500 gram birth weights
2. Neonates who tolerated minimal enteral feeding within postnatal first week

Exclusion criteria:

1. PROM\> 24 hours and/or chorioamnionitis
2. Mechanic ventilation supply more than 7 days
3. Culture proven sepsis
4. Major congenital anomaly
5. Patients undergoing surgery

Intervention:

The allocations will contain in opaque, sequentially numbered sealed envelopes. The study group will receive symbiotic preparation (Probiotic ATP, Nobel, 1/2 sachet twice daily); whereas the control group will receive placebo (distilled water; 1 ml per dose twice daily) which will be added to breast milk or formula starting with the first feed.0.5 cc blood sampling will be taken from patients within postnatal 48 hours, 14+2.days, 28+2.days. This samples will turn by cold centrifugation and store at -20 °C temperature. The cytokines will be analysed by ELISA multiplex method.

Arms: arm 1: symbiotic preparation 1/2 sachet twice daily during 30 days arm 2: 2 x 0.5 cc distilled water will be given during 30 days
Interventions: intervention 1: distilled water intervention 2: symbiotic
Intervention descriptions: intervention 1: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days intervention 2: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days

Protocol documents: