ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00175825
Conditions: Epilepsy
Keywords: Epilepsy: partial onset seizures brivaracetam
Sponsor: UCB Pharma
Start date: 2005-11-07; Completion date: 2006-06-29
Enrollment: 210 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.

Detailed description:

Arms: arm 1: Matching Placebo tablets administered twice a day arm 2: Brivaracetam 5 mg/day, 2.5 mg administered twice a day arm 3: Brivaracetam 20 mg/day, 10 mg administered twice a day arm 4: Brivaracetam 50 mg/day, 25 mg administered twice a day
Interventions: intervention 1: Placebo intervention 2: Brivaracetam
Intervention descriptions: intervention 1: Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 7-week Treatment Period intervention 2: Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period

Protocol documents:
Clinical trial NCT00346775
Conditions: Rhinitis, Allergic, Perennial
Keywords: questionnaire nasal spray Seasonal allergic rhinitis nasal spray questionnaire allergic rhinitis
Sponsor: GlaxoSmithKline
Start date: 2006-05-01; Completion date: 2006-06-29
Enrollment: 97 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The Protocol section needs to be updated using the following text "The main goal of the study was to validate the Preference Module of the EARNS-Q and to test the reliability using Treatment Satisfaction Questionnaire for Medicines (TSQM), a validated questionnaire for determining satisfaction among different treatment. The EARNS-Q is divided into 2 modules, an Experience Module and a Preference Module. The Experience Module includes 28 items, fourteen attribute rating items followed by fourteen importance weighing questions. The Preference Module includes the same items along with preference questions related to each item as well as a global preference question.

Detailed description:

Interventions: intervention 1: Beclomethasone dipropionate intervention 2: Flunisolide
Intervention descriptions: intervention 1: Beclomethasone dipropionate intervention 2: Flunisolide

Protocol documents:
Clinical trial NCT00078312
Conditions: Narcolepsy Sleep Apnea, Obstructive Sleep Apnea Syndromes Shift-Work Sleep Disorder
Keywords: Excessive Sleepiness Narcolepsy Cataplexy Sleep Attacks Obstructive Sleep Apnea Obstructive Sleep Hypopnea nCPAP Chronic Shift Work Sleep Disorder Chronic SWSD Circadian Rhythm Disorder Shift Worker Cepahlon Cephalon, Inc Nuvigil
Sponsor: Cephalon
Start date: 2004-01-01; Completion date: 2006-07-01
Enrollment: 328 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the safety and tolerability of Armodafinil (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness associated with a current diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal continuous positive airway pressure \[nCPAP\] therapy), or chronic shift work sleep disorder (SWSD).

Detailed description:

Interventions: intervention 1: CEP-10953 (Armodafinil)
Intervention descriptions: intervention 1: Armodafinil (po) 100 to 250 mg/day up to 12 months

Protocol documents:
Clinical trial NCT00095056
Conditions: Diabetes Mellitus, Type 2 Chronic Renal Insufficiency
Keywords: Type 2 Diabetes Mellitus and Chronic Renal Insufficiency
Sponsor: Merck Sharp & Dohme LLC
Start date: 2004-10-01; Completion date: 2006-07-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and tolerability of an investigational drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes) and Chronic Renal Insufficiency (inadequate kidney function).

Detailed description:

Arms: arm 1: Participants in the Sitagliptin treatment sequence will receive sitagliptin in Phase A and placebo to glipizide in Phase B. arm 2: Participants in the Placebo treatment sequence will receive placebo to sitagliptin in Phase A and glipizide in Phase B.
Interventions: intervention 1: sitagliptin intervention 2: Placebo to Sitagliptin intervention 3: glipizide intervention 4: Placebo to glipizide
Intervention descriptions: intervention 1: One (participants with visit 1 estimated creatinine clearance \<30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to \<50 mL/min; not on dialysis) tablets of 25 mg Sitagliptin daily. intervention 2: One (participants with visit 1 estimated creatinine clearance \<30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to \<50 mL/min and not on dialysis) tablets of placebo to sitagliptin 25 mg daily. intervention 3: One 5 mg glipizide tablet per day. The dose of glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations. intervention 4: One placebo to glipizide 5 mg tablet per day. The dose of placebo to glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations.

Protocol documents:
Clinical trial NCT00106639
Conditions: Kidney Transplantation
Keywords: tofacitinib CP-690550 kidney transplant
Sponsor: Pfizer
Start date: 2005-05-01; Completion date: 2006-07-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with basiliximab induction, mycophenolate mofetil and corticosteroids, in kidney transplant patients. Stage 1 was to randomize approximately 54 subjects. After all Stage 1 subjects had completed 6 months of treatment, Stage 2 was to randomize an additional 195 subjects to the same treatment groups.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: tacrolimus
Intervention descriptions: intervention 1: 15 mg twice daily intervention 2: 30 mg twice daily intervention 3: dose adjusted according to level

Protocol documents:
Clinical trial NCT00168818
Conditions: Thromboembolism Arthroplasty, Replacement, Hip
Sponsor: Boehringer Ingelheim
Start date: 2004-11-01; Completion date: 2006-07-01
Enrollment: 3494 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.

Detailed description:

Arms: arm 1: daily dose 150 mg once daily, half a dose on the day of surgery arm 2: daily dose 220 mg once daily, half a dose on the day of surgery arm 3: 40 mg once daily
Interventions: intervention 1: dabigatran etexilate intervention 2: dabigatran etexilate intervention 3: enoxaparin
Intervention descriptions: intervention 1: daily dose 150 mg once daily, half a dose on the day of surgery intervention 2: daily dose 150 mg once daily, half a dose on the day of surgery intervention 3: 40 mg once daily

Protocol documents:
Clinical trial NCT00203229
Conditions: Trigeminal Neuralgia
Keywords: Double-Blind Placebo-Controlled
Sponsor: Thomas Jefferson University
Start date: 2003-06-01; Completion date: 2006-07-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research study will look at the safety (e.g., the occurrence of side effects) and efficacy (how well the drug works in reducing trigeminal neuralgia attacks) of a drug called lamotrigine in adults with trigeminal neuralgia.

Detailed description:
A randomized, double-blind, placebo-controlled, add-on study of lamotrigine in trigeminal neuralgia. Thirty-eight eligible patients with trigeminal neuralgia will be enrolled; nineteen will be randomized to the active medication group and nineteen to the placebo group. Using a daily diary, all patients will document their overall pain level and attack frequency and intensity for four weeks. After the four week baseline period, patients will initiate medication (lamotrigine or placebo). Patients will titrate until either they reach the maximum dose of 400mg per day and up to 700mg for patients on enzyme-inducing anti-epileptic drugs (EIAED's), their side effects inhibit further increases (known as maximum tolerated dose (MTD)), or their trigeminal neuralgia pain resolves (referred to as pain free dose (PFD)) over eight weeks. Patients will remain on a constant dose of prior medications throughout the study. Patients will remain on maximum dose, MTD, or PFD for a maintenance period of at least eight weeks, and at the end of the maintenance period patients who opt to stay on the medication will be unblinded as to medication and dosage. Primary outcome will be average intensity of daily pain.

Arms: arm 1: Dosing Schedule Morning Evening Daily Total Week 1-2 ---- 50mg 50mg Week 3-4 50mg 50mg 100mg Week 5 100mg 100mg 200mg Week 6 150mg 150mg 300mg Week 7 200mg 200mg 400mg Week 8 (if needed for pain) 200mg 300mg 500mg Week 9 (if needed for pain) 300mg 300mg 600mg Week 10 (if needed for pain) 300mg 400mg 700mg arm 2: Dosing Schedule Morning Evening Daily Total Week 1-2 ---- 50mg 50mg Week 3-4 50mg 50mg 100mg Week 5 100mg 100mg 200mg Week 6 150mg 150mg 300mg Week 7 200mg 200mg 400mg Week 8 (if needed for pain) 200mg 300mg 500mg Week 9 (if needed for pain) 300mg 300mg 600mg Week 10 (if needed for pain) 300mg 400mg 700mg
Interventions: intervention 1: lamotrigine intervention 2: Placebo
Intervention descriptions: intervention 1: The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal). This drug is an anti-seizure medication. intervention 2: The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. The placebo arm is titrated in the exact same manor as the active drug arm.

Protocol documents:
Clinical trial NCT00214526
Conditions: Asthma
Keywords: Asthma Bronchial Thermoplasty Airway Hyperresponsiveness
Sponsor: Asthmatx, Inc.
Start date: 2002-11-01; Completion date: 2006-07-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to demonstrate the effectiveness and safety of the Alair System for the treatment of asthma.

This will be a multicenter, randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy. One-hundred and ten subjects will be randomized 1:1 to either the Alair Group (Medical management + Alair treatment),or Control Group (Medical management only).

Detailed description:
Multicenter, randomized, controlled clinical trial conducted at 11 Investigational Sites in 4 countries (Canada, United Kingdom, Denmark, and Brazil).

Subjects underwent Baseline evaluations, Alair treatments or Control Visits, and follow-up evaluations at 12-Weeks, 6-Months, and 12-Months after the last Treatment or Control Visit. In order to maximize the power of the study, Baseline and Follow-up testing was conducted in 2 parts. In the first part subjects continued to take their asthma maintenance medications (inhaled corticosteroids (ICS) and long acting β2-agonists (LABA) during the test period. This is designated as the "ON-LABA" Phase. Following ON-LABA testing subjects were asked to abstain from LABA for the second part of the testing, and these results are designated as the "OFF-LABA" Phase.

Arms: arm 1: Conventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System. arm 2: Conventional therapy with ICS+LABA.
Interventions: intervention 1: Bronchial thermoplasty with the Alair System intervention 2: Conventional therapy with ICS+LABA
Intervention descriptions: intervention 1: Conventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System. intervention 2: Conventional therapy with ICS+LABA.

Protocol documents:
Clinical trial NCT00215540
Conditions: Respiratory Distress Syndrome, Newborn Premature Birth Bronchopulmonary Dysplasia
Keywords: Double-blind Low Birth Weight Surfactant Placebo-Controlled Premature Birth
Sponsor: Windtree Therapeutics
Start date: 2005-02-01; Completion date: 2006-07-01
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required continued intubation and received surfactants for the prevention or treatment of respiratory distress syndrome (RDS).

Detailed description:
Determine the safety and tolerability of SURFAXIN administration in the first weeks of life as a therapeutic approach for prevention of BPD. Determine whether treatment with SURFAXIN during the first two to three weeks of life can decrease the proportion of infants on mechanical ventilation or oxygen or the incidence of death or BPD in VLBW infants when assessed at 28 days of life and 36 weeks post-menstrual age (as determined by the need for supplemental oxygen).

Arms: arm 1: SURFAXIN (lucinactant) at 175 mg/kg arm 2: SURFAXIN (lucinactant) at 90 mg/kg arm 3: Sham air using 3.0 mL/kg volume of air
Interventions: intervention 1: Lucinactant 175 mg/kg intervention 2: Lucinactant 90 mg/kg intervention 3: Placebo
Intervention descriptions: intervention 1: Administered via slow intra-tracheal instillation at a dose of 175 mg/kg (5.8 mL/kg of a 30-mg/mL suspension). Initial treatment given no later than 1 hour after randomization. Additional treatments were administered every 48 hours up to a maximum of 5 doses (up to day of life (DOL) 18). intervention 2: Administered via slow intra-tracheal instillation at a dose of 90 mg/kg (3.0 mL/kg of a 30-mg/mL suspension). Initial treatment given no later than 1 hour after randomization. Additional treatments were administered every 48 hours up to a maximum of 5 doses (up to DOL 18). intervention 3: Sham air was administered via slow intratracheal instillation at a dose of 3.0 mL/kg volume of air. The initial treatment was given no later than 1 hour after randomization. Additional treatment were administered every 48 hours up to a maximum of 5 doses (up to DOL 18).

Protocol documents:
Clinical trial NCT00228553
Conditions: Excessive Daytime Sleepiness Narcolepsy Obstructive Sleep Apnea/Hypopnea Syndrome Chronic Shift Work Sleep Disorder
Sponsor: Cephalon
Start date: 2004-05-01; Completion date: 2006-07-01
Enrollment: 743 participants; Allocation: NON_RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder

Detailed description:

Arms: arm 1: Armodafinil 100 to 250 mg/day
Interventions: intervention 1: Armodafinil 100 to 250 mg/day
Intervention descriptions: intervention 1: Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD).

Protocol documents:
Clinical trial NCT00228566
Conditions: Excessive Daytime Sleepiness Narcolepsy Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
Sponsor: Cephalon
Start date: 2005-10-01; Completion date: 2006-07-01
Enrollment: 247 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess patient reported outcomes with armodafinil treatment in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to engage in life activities (ie, daily or work and family and/or social activities), and effects on fatigue. Clinician ratings on patient response to armodafinil treatment will also be assessed.

Detailed description:

Interventions: intervention 1: Armodafinil
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00361712
Conditions: Obstetric Pain
Keywords: Epidural analgesia labor cytokines
Sponsor: Rabin Medical Center
Start date: 2006-07-01; Completion date: 2006-07-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
During labor there is an increased production of inflammatory mediators called cytokines. Higher concentration of certain cytokines has been linked to adverse neonatal and maternal outcomes.

Epidural analgesia is commonly performed after the parturient feels labor pain.

We hypothesis that preemptive epidural analgesia (initiated before labor pain begins)can influence the production of cytokines.

Detailed description:
The interrelationship between vaginal labor, cytokine production, and epidural analgesia is unknown. Vaginal delivery is thought to induce a maternal inflammatory response. Though epidural analgesia during labor was found to significantly influence peripartum maternal and newborn interleukin concentrations, these studies did not address at what stage epidural analgesia was performed. Preemptive analgesia has been found to be associated with attenuated proinflammatory cytokines, at least in the postoperative period.

Healthy ASA I term parturients (\>37 weeks) being accepted into delivery ward and wanting epidural analgesia will be studied.

Parturients will be divided into two groups:

* Group I- those who have painless contractions awaiting augmentation of labor.
* Group II- parturients with cervical dilatation and painful labor (VAS \>5).

Parturients in Group I will be given epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS\<3). Parturients in Group 2 will be given epidural analgesia as soon as possible.

Epidural analgesia protocol will be identical for both groups: graduated doses of bupivicaine 0.1% 15cc and 100 mcg fentanyl followed by patient controlled analgesia at a concentration of bupivicaine 0.1% and fentanyl 2 mcg/cc delivered at 10cc per hour with possible boluses of 5 cc every ten minutes.

Maternal serum will be drawn before epidural insertion and 18-24 hours after delivery. Placental blood will be drawn after delivery.

These blood sample will be assessed for IL-1Beta, TNF alpha, IL-1ra, IL-2, Il-6, IL-8, IL-10, IL-18.

The patient's chart will be prospectively analyzed for demographic information about parturient and complications and progress of labor.

Arms: arm 1: Parturients will receive epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS\<3). arm 2: Parturients with cervical dilatation and painful labor (VAS \>5) will receive epidural analgesia as soon as possible
Interventions: intervention 1: Preemptive epidural analgesia intervention 2: Standard of care
Intervention descriptions: intervention 1: Parturients will receive early epidural analgesia before onset of painful contractions as oppose to standard of care in which parturients receive epidural analgesia with onset of painful contractions. intervention 2: Epidural analgesia with parturients with cervical dilatation and painful labor (VAS \>5)

Protocol documents:
Clinical trial NCT00380081
Conditions: Insomnia
Keywords: Insomnia
Sponsor: Transcept Pharmaceuticals
Start date: 2006-04-01; Completion date: 2006-07-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate sleep onset following administration of Transcept zolpidem tartrate sublingual tablet versus placebo in adult insomnia patients.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: zolpidem tartrate sublingual tablet 3.5mg intervention 2: zolpidem tartrate sublingual tablet 1.75mg intervention 3: Placebo
Intervention descriptions: intervention 1: Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved. intervention 2: Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved. intervention 3: Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

Protocol documents:
Clinical trial NCT00803790
Conditions: Osteoporosis
Sponsor: Organon and Co
Start date: 2006-05-01; Completion date: 2006-07-01
Enrollment: 318 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate the bioequivalence of alendronate in combination with vitamin D compared to alendronate alone and the bioequivalence of vitamin D in combination with alendronate compared to vitamin D alone.

This was an open-label, randomized, 2-part, crossover study. Each participant participated in one part of the study only (i.e., each participant participated only in Part I or only in Part II). Participants entered the study sequentially within each part of the study. A washout of at least 12 days separated each treatment period within each part of the study.

Detailed description:

Arms: arm 1: Participants in Part 1 received 70mg alendronate+5600 International Units (IU) vitamin D combination tablet in Period 1 followed by 70mg alendronate tablet in Period 2. A washout of at least 12 days separated each treatment period. arm 2: Participants in Part 1 received 70mg alendronate tablet in Period 1 followed by 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period. arm 3: Participants in Part 2 received 70mg alendronate+5600 IU vitamin D combination tablet in Period 1 followed by a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 2. A washout of at least 12 days separated each treatment period. arm 4: Participants in Part 2 received a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 1 followed by a 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.
Interventions: intervention 1: alendronate sodium+vitamin D combination intervention 2: Comparator: alendronate intervention 3: Comparator: Vitamin D
Intervention descriptions: intervention 1: A single dose tablet of 70mg alendronate sodium+5600 IU vitamin D combination tablet in one treatment period of each sequence. intervention 2: A single dose tablet of 70mg alendronate in one treatment period of each sequence. intervention 3: Two tablets of 2800 IU vitamin D, totaling 5600 IU, in one treatment period of each sequence.

Protocol documents: