ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01703819
Conditions: Acute Stress Reaction
Keywords: acute stress reaction stress stress perception physiological stress response Neurexan
Sponsor: Biologische Heilmittel Heel GmbH
Start date: 2012-10-01; Completion date: 2013-04-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of acutely dosed Neurexan using an experimental stress test called the Trier Social Stress Test

Detailed description:
An acute stress reaction is a biopsychological condition arising in response to an event which is individually regarded as emotionally stressful. The onset of a stress response is associated with specific physiological actions in the sympathetic nervous system, both directly and indirectly through the release of adrenaline and to a lesser extent noradrenaline from the medulla of the adrenal glands. These catecholamine hormones facilitate immediate physical reactions by triggering increases in heart rate and breathing, constricting blood vessels. The other major player in the acute stress response is the hypothalamic-pituitary-adrenal axis.

Although stress has been described as a non-specific psychophysiological response to environmental stimuli, it is possible to discern specific bodily stress responses caused by specific emotional reactions to novel, ambivalent or uncontrollable situations and stimuli. For example, social stress induces elevated cortisol levels, particularly if the stressor is uncontrollable, unpredictable, and constitutes a social-evaluative threat due to the judgment of others such as in the Trier Social Stress Test. Usually, the TSST induces a two-fold increase in saliva cortisol with peaks around 10-20 min. after stress test termination. Also, an average increase in heart rates of around 20 beats per minute (bpm) is observed during the TSST. In addition, emotional states and feelings have been shown to be affected by this stress test, such as marked increases in stress perception,anxiety and emotional insecurity as well as decreases in mood, calmness and feeling awake.

Preliminary results indicate that Neurexan® may improve coping abilities in stressful situations. This study aims to investigate the effect of Neurexan® on subjectively perceived nervousness and tension during an acute stressful situation and to characterize the efficacy profile of Neurexan®.

Arms: arm 1: 0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes arm 2: 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Interventions: intervention 1: Neurexan® intervention 2: Placebo
Intervention descriptions: intervention 1: 0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes intervention 2: 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Protocol documents:
Clinical trial NCT01703832
Conditions: Acute Stress Reaction
Keywords: acute stress reaction stress stress perception physiological stress response Neurexan
Sponsor: Biologische Heilmittel Heel GmbH
Start date: 2012-10-01; Completion date: 2013-04-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to explore the efficacy of acutely dosed Neurexan using an experimental stress test called the Trier Social Stress Test

Detailed description:
An acute stress reaction is a biopsychological condition arising in response to an event which is individually regarded as emotionally stressful. The onset of a stress response is associated with specific physiological actions in the sympathetic nervous system, both directly and indirectly through the release of adrenaline and to a lesser extent noradrenaline from the medulla of the adrenal glands. These catecholamine hormones facilitate immediate physical reactions by triggering increases in heart rate and breathing, constricting blood vessels. The other major player in the acute stress response is the hypothalamic-pituitary-adrenal axis.

Although stress has been described as a non-specific psychophysiological response to environmental stimuli, it is possible to discern specific bodily stress responses caused by specific emotional reactions to novel, ambivalent or uncontrollable situations and stimuli. For example, social stress induces elevated cortisol levels, particularly if the stressor is uncontrollable, unpredictable, and constitutes a social-evaluative threat due to the judgment of others such as in the Trier Social Stress Test). Usually, the TSST induces a two-fold increase in saliva cortisol with peaks around 10-20 min. after stress test termination. Also, an average increase in heart rates of around 20 beats per minute (bpm) is observed during the TSST. In addition, emotional states and feelings have been shown to be affected by this stress test, such as marked increases in stress perception,anxiety and emotional insecurity as well as decreases in mood, calmness and feeling awake.

Preliminary results indicate that Neurexan® may improve coping abilities in stressful situations. This study aims to investigate the effect of Neurexan® on subjectively perceived nervousness and tension during an acute stressful situation and to characterize the efficacy profile of Neurexan®.

Arms: arm 1: 0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes arm 2: no tablet intake and subjects will undergo the natural course
Interventions: intervention 1: Neurexan®
Intervention descriptions: intervention 1: 0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Protocol documents:
Clinical trial NCT01708915
Conditions: Acute Low Back Pain
Sponsor: Boehringer Ingelheim
Start date: 2012-10-01; Completion date: 2013-04-01
Enrollment: 805 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to assess the efficacy and tolerability of Nicoboxil/Nonivamide ointment in comparison to Nicoboxil, Nonivamide, and placebo ointments for the treatment of acute low back pain.

Detailed description:

Arms: arm 1: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period arm 2: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period arm 3: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period arm 4: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
Interventions: intervention 1: nicoboxil intervention 2: placebo matching nonivamide + nicoboxil intervention 3: nonivamide + nicoboxil (Finalgon) intervention 4: nonivamide
Intervention descriptions: intervention 1: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period intervention 2: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period intervention 3: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period intervention 4: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period

Protocol documents:
Clinical trial NCT01723904
Conditions: Advanced Parkinson's Disease
Keywords: Rotigotine Neupro
Sponsor: UCB BIOSCIENCES GmbH
Start date: 2012-10-01; Completion date: 2013-04-01
Enrollment: 90 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is to investigate the safety and efficacy of Rotigotine add-on therapy with low doses of Pramipexole or Ropinirole in patients with advanced-stage Parkinson's Disease (PD) who have insufficient response to L-dopa and low doses dopamine receptor agonists.

Detailed description:

Arms: arm 1: \- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.

Duration of the Titration Period: Between 1 week and 5 weeks.

\- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.

Duration of the Maintenance Period: Between 3 weeks and 7 weeks.
Interventions: intervention 1: Rotigotine
Intervention descriptions: intervention 1: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.

Protocol documents:
Clinical trial NCT01732263
Conditions: Hepatic Impairment Healthy
Sponsor: Shire
Start date: 2012-11-09; Completion date: 2013-04-01
Enrollment: 44 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate how much of the study drug SSP-004184 (SPD602) is absorbed by the body and how long it takes to be eliminated from the body in healthy subjects and subjects with mild, moderate, and severe hepatic (liver) impairment compared with subjects with healthy normal liver function.

Detailed description:

Arms: arm 1: The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: SSP-004184
Intervention descriptions: intervention 1: All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1

Protocol documents:
Clinical trial NCT01732692
Conditions: Bowel Preparation Prior to Endoscopic, Radiological and Other Examinations as Well as to Surgical Procedures Which Require Empty Bowel.
Keywords: Bowel preparation, MOVIPREP®
Sponsor: Takeda
Start date: 2012-11-01; Completion date: 2013-04-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare colon cleansing quality induced by the 2 different modes of MOVIPREP® intake in 5 colon segments prior to colonoscopy.

Detailed description:
All participants enrolled to the study will be allocated to one of two arms. Patients of the experimental morning-only regimen arm will prepare and take MOVIPREP® solution in the full dose - 2 litres of MOVIPREP® preparation in the early morning on the day of the colonoscopy clinical procedure. Participants in the standard split-dose regimen arm will prepare and take MOVIPREP® solution in split doses - ½ of dose (1 litre) the evening before + ½ of dose (1 litre) of MOVIPREP® preparation in the morning of the day of the colonoscopy.

The study consists of three visits. Participation in the study lasts no more than 11 days; 3 days as minimum.

There is no follow-up period planned except in case of any adverse events (AEs) when the follow-up period will last until the participant has recovered or until all AE-related queries for the participant have been resolved.

Arms: arm 1: MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy. arm 2: MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
Interventions: intervention 1: MOVIPREP
Intervention descriptions: intervention 1: MOVIPREP solution

Protocol documents:
Clinical trial NCT01736527
Conditions: Pharmacokinetics
Sponsor: Bausch & Lomb Incorporated
Start date: 2013-01-01; Completion date: 2013-04-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To assess the levels of loteprednol etabonate (LE) in tear fluid following a single topical instillation of LE ophthalmic gel 0.5% formulation to healthy volunteers.

Detailed description:

Arms: arm 1: A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.
Interventions: intervention 1: LE Gel
Intervention descriptions: intervention 1: Single drop of LE Gel 0.5% administered to the study eye on visit 2

Protocol documents:
Clinical trial NCT01738698
Conditions: Schizophrenia
Sponsor: Shire
Start date: 2012-11-01; Completion date: 2013-04-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to determine whether SPD489 40 mg, 100 mg, and 160 mg are effective and safe in the treatment of Negative Symptoms of Schizophrenia (NSS).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: SPD489 40mg intervention 2: SPD489 100mg intervention 3: SPD489 160mg intervention 4: Placebo
Intervention descriptions: intervention 1: Oral administration of 40 mg once-daily for up to 12 weeks intervention 2: Oral administration of 100 mg once-daily for up to 12 weeks intervention 3: Oral administration of 160 mg once-daily for up to 12 weeks intervention 4: Oral administration once-daily for 12 weeks

Protocol documents:
Clinical trial NCT01751867
Conditions: Myelodysplastic Syndrome
Keywords: Myelodysplastic Syndrome Dacogen Oncology Decitabine Bone marrow disorders
Sponsor: Xian-Janssen Pharmaceutical Ltd.
Start date: 2009-08-01; Completion date: 2013-04-01
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effectiveness and safety of decitabine in the treatment of myelodysplastic syndrome (name of a group of conditions that occur when the blood-forming cells in the bone marrow are damaged) in Chinese patients.

Detailed description:
This is a prospective (look forward using periodic observations collected predominantly following patient enrollment), open-label (all people involved in the study know the identity of the assigned drug), Phase IIIb study to evaluate the efficacy and safety of decitabine in the treatment of myelodysplastic syndrome (MDS). Patients are randomized (study drug assigned by chance) in 1:1 ratio to receive treatment with decitabine either 3-day or 5-day course of therapy. When a minimum of 30 patients are reached for 3-day course of therapy, the rest of the patients will all be enrolled into 5-day course of therapy. Each patient in the study treated for a minimum of 4 cycles; however, a complete or partial response may take longer than 4 cycles. The entire study duration for each patient will be approximately two years. Safety will be evaluated for each patient by monitoring of adverse events, physical examinations, vital signs measurements, electrocardiogram, hematology and clinical chemistry testing.

Arms: arm 1: Decitabine will be administered at a dose of 15 mg/m2 as a continuous intravenous infusion within a 3 hour period, repeated every 8 hours for 3 consecutive days. Cycles will be repeated every 6 weeks. arm 2: Decitabine will be administered at a dose of 20 mg/m2 as a intravenous infusion within 1 hour, once daily for 5 consecutive days. Cycles will be repeated every 4 weeks.
Interventions: intervention 1: Decitabine at 15 mg/m2 intervention 2: Decitabine at 20 mg/m2
Intervention descriptions: intervention 1: Decitabine will be given at a dose of 15 mg/m2 as a continuous intravenous infusion within a 3-hour intravenous infusion, repeated every 8 hours for 3 consecutive days.The total dose per day is 45 mg/m2; The total dose per course is 135 mg/m2. Cycles will be repeated every 6 weeks. intervention 2: Decitabine will be given at a dose of 20 mg/m2 as 1-hour IV infusion once daily on Days 1 through 5, of a 4-week treatment cycle.

Protocol documents:
Clinical trial NCT01759446
Conditions: Opioid-Related Disorders
Sponsor: Acura Pharmaceuticals Inc.
Start date: 2013-02-01; Completion date: 2013-04-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To determine the relative abuse potential of VYCAVERT (hydrocodone bitartrate and acetaminophen) compared to GENERIC H/A (hydrocodone bitartrate and acetaminophen) when crushed and administered intranasally to non dependent, recreational opioid users.

Detailed description:

Arms: arm 1: Placebo powder snorted with all other arms taken crossover therafter arm 2: Generic hydrocodone/APAP 10/325mg pulverized tablet snorted with all other arms taken crossover therafter arm 3: Vycavert hydrocodone/APAP 10/325mg pulverized tablet snorted with all other arms taken crossover therafter arm 4: Generic hydrocodone/APAP 10/325mg plus additional inactive ingredients pulverized tablet snorted with all other arms taken crossover therafter arm 5: Generic hydrocodone/APAP 10/325mg plus one placebo pulverized tablet snorted with all other arms taken crossover therafter
Interventions: intervention 1: Placebo taken first intervention 2: Generic H/A taken first intervention 3: Vycavert taken first intervention 4: Generic H/A plus i taken first intervention 5: Generic H/A plus p taken first
Intervention descriptions: intervention 1: Snorted in both nostrils within 5 minutes; 48 hours washout between doses intervention 2: Snorted in both nostrils within 5 minutes; 48 hours washout between doses intervention 3: Snorted in both nostrils within 5 minutes; 48 hours washout between doses intervention 4: Snorted in both nostrils within 5 minutes; 48 hours washout between doses intervention 5: Snorted in both nostrils within 5 minutes; 48 hours washout between doses

Protocol documents:
Clinical trial NCT01760889
Conditions: Schizophrenia
Sponsor: Shire
Start date: 2013-02-01; Completion date: 2013-04-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to determine whether SPD489 low dose range (40, 80, or 100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of Negative Symptoms.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: SPD489 low dose range (40mg, 80mg, and 100mg) intervention 2: SPD489 high dose range (120mg, 140mg and 160mg) intervention 3: Placebo
Intervention descriptions: intervention 1: Capsule, dose titration,

* 40 mg capsule once-daily for 1 week; then
* 80 mg capsule once-daily for 4 weeks; then,
* 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
* if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks intervention 2: Capsule, dose titration,

* 40 mg capsule once-daily for 1 week; then
* 80 mg capsule once daily for 1 week; then
* 120 mg capsule once-daily for 1 week, then,
* 140 mg capsule once-daily for 2 weeks, then
* 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
* if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks intervention 3: One capsule a day for 26 weeks

Protocol documents:
Clinical trial NCT01760993
Conditions: Schizophrenia
Keywords: Not Required
Sponsor: Shire
Start date: 2013-02-01; Completion date: 2013-04-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study is to determine if the long-term use of SPD489 (40, 80, 100, 120, 140, and 160mg) administered as a daily morning is safe and tolerable.

Detailed description:
Not required

Arms: arm 1: None
Interventions: intervention 1: SPD489
Intervention descriptions: intervention 1: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks

Protocol documents:
Clinical trial NCT01766050
Conditions: Transplant Rejection
Sponsor: Bristol-Myers Squibb
Start date: 2013-01-01; Completion date: 2013-04-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the effects of belatacept on the pharmacokinetics of caffeine, losartan, omeprazole, dextromethorphan and midazolam

Detailed description:

Arms: arm 1: Inje Cocktail consisting of (200 mg Caffeine, 50 mg losartan tablet, 40 mg Omeprazole capsule, 30 mg Dextromethorphan capsule and 5 mg Midazolam oral syrup) administered on Days 1, 4, 7 and 11

Belatacept 10 mg/kg Intravenous (IV) solution, administered on Day 4
Interventions: intervention 1: Caffeine intervention 2: Losartan intervention 3: Omeprazole intervention 4: Dextromethorphan intervention 5: Midazolam intervention 6: Belatacept
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT01778985
Conditions: Pelvic Organ Prolapse Menopause
Keywords: Pelvic organ prolapse Menopause Estrogen Premarin
Sponsor: University of Texas Southwestern Medical Center
Start date: 2012-12-01; Completion date: 2013-04-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to determine how vaginal estrogen cream given for several weeks before pelvic reconstructive therapy will effect elastic fiber assembly in the muscularis layer of the vaginal wall. Postmenopausal women with at least Stage 2 pelvic organ prolapse will receive either estrogen vaginal cream or placebo cream 6-8 weeks prior to reconstructive surgery. At time of surgery, full thickness biopsies will be obtained from a standardized location at the top of vagina. The investigators will measure the thickness of the vaginal muscularis, elastic fiber number and morphology, and analyze if elastic fiber synthesis or degradation is affected by estrogen therapy. The results will provide important data to support a larger clinical trial to determine if preoperative and maintenance estrogen therapy alter long-term success rates of pelvic reconstructive surgery for pelvic organ prolapse.

Detailed description:

Arms: arm 1: Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery. arm 2: Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Interventions: intervention 1: Premarin intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01787032
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-01-01; Completion date: 2013-04-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this trial is to investigate the relative bioavailability of a single oral dose of BI 113608 without and with ketoconazole and voriconazole at steady state. The assessment of safety and tolerability of BI 113608 administered alone and upon co-administration will be an additional objective of this trial.

Detailed description:

Arms: arm 1: tablets with 240 ml water arm 2: tablets with 240 ml water arm 3: tablets with 240 ml water
Interventions: intervention 1: BI 113608 intervention 2: BI 113608 intervention 3: BI 113608 intervention 4: Ketoconazole intervention 5: Voriconazole
Intervention descriptions: intervention 1: tablet intervention 2: tablet intervention 3: tablet intervention 4: tablet intervention 5: tablet

Protocol documents: