ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01118273
Conditions: Sleep
Keywords: Naproxen sodium Diphenhydramine Drugs, Investigational
Sponsor: Bayer
Start date: 2008-01-01; Completion date: 2008-02-01
Enrollment: 162 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and an ibuprofen and diphenhydramine combination

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg intervention 2: Naproxen Sodium 440 mg (BAYH6689) intervention 3: Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg intervention 4: Naproxen Sodium 220 mg (BAYH6689) intervention 5: DPH 50mg intervention 6: Ibuprofen 400 mg / Diphenhydramine citrate 76 mg
Intervention descriptions: intervention 1: Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. intervention 2: Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally. intervention 3: One dose of naproxen sodium 220 mg plus diphenhydramine 50 mg intervention 4: Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally. intervention 5: Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally. intervention 6: Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.

Protocol documents:
Clinical trial NCT01172353
Conditions: Renal Failure
Keywords: contras-induced nephropathy
Sponsor: Hospital Sao Lucas da PUCRS
Start date: 2004-07-01; Completion date: 2008-02-01
Enrollment: 301 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether hydration with sodium bicarbonate is superior to hydration with saline to prevent contrast-induced nephropathy.

Detailed description:

Arms: arm 1: hydration with sodium bicarbonate arm 2: hydration with saline 1ml/Kg/h for 6 hours
Interventions: intervention 1: sodium bicarbonate intervention 2: saline
Intervention descriptions: intervention 1: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours intervention 2: hydration with saline 1ml/Kg/h for 6 hours

Protocol documents:
Clinical trial NCT01240382
Conditions: Dry Eye
Sponsor: Santen Pharmaceutical Co., Ltd.
Start date: ; Completion date: 2008-02-01
Enrollment: 332 participants; Allocation: ; Intervention model: 

Brief summary:
To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6 times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate ophthalmic solution (0.1% HA) (one drop at a time, 6 times daily, 4 weeks topical administration), is at least non-inferior in the change in fluorescein staining score, and is superior in the change in Rose bengal score, in a multicenter, double-masked, parallel-group comparison study. Safety profile will likewise be compared.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: 3% DE-089 ophthalmic solution intervention 2: 0.1% sodium hyaluronate ophthalmic solution
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01250210
Conditions: Ovulation Suppression
Keywords: contraception pregnancy prevention
Sponsor: Agile Therapeutics
Start date: 2007-09-01; Completion date: 2008-02-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the adequacy of ovulation suppression, cycle control, and safety of three transdermal contraceptive delivery systems (TCDSs).

Detailed description:
The primary objective was to evaluate the adequacy of ovulation suppression, cycle control, and safety of three transdermal contraceptive delivery systems (TCDSs) containing 2 different doses of levonorgestrel (LNG) and 3 different doses of ethinyl estradiol (EE) during 3 consecutive cycles of administration of each treatment.

Arms: arm 1: Drug intervention with levonorgestrel and ethinyl estradiol : AG200-15 a transdermal contraceptive system containing 2.60 mg of levonorgestrel and 2.30 mg of ethinyl estradiol. arm 2: Drug intervention with levonorgestrel and ethinyl estradiol: AG200 a transdermal contraceptive system containing 2.17 mg of levonorgestrel and 1.92 of ethinyl estradiol. arm 3: Drug intervention with levonorgestrel and ethinyl estradiol: AG200LE a transdermal contraceptive system containing 2.17 mg of levonorgestrel and 1.28 mg of ethinyl estradiol.
Interventions: intervention 1: levonorgestrel and ethinyl estradiol
Intervention descriptions: intervention 1: pregnancy prevention

Protocol documents:
Clinical trial NCT01998893
Conditions: Non-Hodgkin's Lymphoma
Sponsor: Hoffmann-La Roche
Start date: 1997-01-01; Completion date: 2008-02-01
Enrollment: 38 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of MabThera/Rituxan in patients with relapsed low-grade centroblastic centrocytic non-Hodgkin's lymphoma. Patients will receive once-weekly intravenous MabThera/Rituxan for 4 weeks; responding patients will be treated a second time in case of relapse (defined as progression after complete or partial response). The anticipated time on study treatment is \<3 months.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: rituximab [MabThera/Rituxan]
Intervention descriptions: intervention 1: 375 mg/m2 iv weekly for 4 weeks; for responders to first course of therapy a second course is possible after relapse

Protocol documents:
Clinical trial NCT02005484
Conditions: Gastric Cancer
Sponsor: Hoffmann-La Roche
Start date: 2004-01-01; Completion date: 2008-02-01
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of Herceptin in patients with metastatic or advanced gastric cancer with disease progression during platinum-based or 5-fluoropyrimidine-based chemotherapy. The anticipated time on study treatment is until disease progression.

Detailed description:

Arms: arm 1: Initial dose of 4 milligrams (mg) per (/) kilogram (kg) by body weight (BW), followed by 2 mg/kg BW at each subsequent visit
Interventions: intervention 1: Trastuzumab
Intervention descriptions: intervention 1: 4 mg/kg initial dose, followed by 2 mg/kg

Protocol documents:
Clinical trial NCT04004507
Conditions: Decrease in Night Vision Disturbance; Vision, Loss
Keywords: Night Vision Disturbances NVD Glare Halos Starbursts Nyxol
Sponsor: Ocuphire Pharma, Inc.
Start date: 2007-08-01; Completion date: 2008-02-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are:

* To assess the effect of ophthalmic phentolamine mesylate in mesopic conditions on the four endpoints:

  1. Contrast sensitivity
  2. Low contrast visual acuity
  3. Wavefront aberrometry
  4. Subjective questionnaire
* To assess the safety of ophthalmic phentolamine mesylate

Detailed description:
Double-masked, placebo-controlled, single-dose Phase 2 study in 24 patients experiencing severe night vision difficulties to evaluate ocular and systemic safety and efficacy following administration of one drop of phentolamine mesylate 1.0% QD in each eye for 1 day.

Arms: arm 1: 1 drop in each eye (QD) for one day. arm 2: 1 drop in each eye (QD) for one day.
Interventions: intervention 1: Phentolamine Mesylate Ophthalmic Solution 1% intervention 2: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Intervention descriptions: intervention 1: Topical Sterile Ophthalmic Solution intervention 2: Topical Sterile Ophthalmic Solution

Protocol documents:
Clinical trial NCT00528970
Conditions: Ileus
Keywords: POI Hernia Ventral Wall Hernia Repair Post Operative Ileus
Sponsor: Bausch Health Americas, Inc.
Start date: 2007-10-17; Completion date: 2008-02-05
Enrollment: 374 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of two different dose regimens (12 milligrams \[mg\] and 24 mg) of IV MOA-728 versus placebo in shortening the time to return of bowel function in participants receiving opioid analgesia administered via patient-controlled anesthesia (PCA), and who had undergone repair of large (greater than or equal to \[≥\]10 centimeters) ventral hernias with or without a mesh prosthesis via laparotomy or laparoscopy.

Detailed description:

Arms: arm 1: Participants will receive methylnaltrexone (MOA-728) 12 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days. arm 2: Participants will receive MOA-728 24 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days. arm 3: Participants will receive placebo matching to MOA-728 as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days.
Interventions: intervention 1: MOA-728 intervention 2: Placebo
Intervention descriptions: intervention 1: MOA-728 will be administered per the dose and schedule specified in the arm. intervention 2: Placebo matching to MOA-728 will be administered per the schedule specified in the arm.

Protocol documents:
Clinical trial NCT01743677
Conditions: Healthy
Keywords: TQT study CP-690 550
Sponsor: Pfizer
Start date: 2007-10-26; Completion date: 2008-02-09
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
ICH E14 recommends that a thorough QT/QTc (TQT) study should be performed to determine whether intensive monitoring of QT interval in target patient populations is required during later stages of development. The current study is designed to ascertain whether CP-690,550 is associated with QTc prolongation.

Detailed description:
The current study is designed to ascertain whether CP-690,550 is associated with QTc prolongation

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: CP-690,550 intervention 2: Placebo intervention 3: Moxifloxacin
Intervention descriptions: intervention 1: Single dose 100 mg (5 x 20 mg tablets) intervention 2: Single dose placebo tablets (5 tablets) intervention 3: Single dose Avelox 400 mg tablet

Protocol documents:
Clinical trial NCT00399490
Conditions: Osteoarthritis OA Knee Pain Arthritis
Keywords: Monoclonal antibody
Sponsor: Pfizer
Start date: 2006-09-15; Completion date: 2008-02-11
Enrollment: 287 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study RN624-CL007 is planned to be an open-label protocol to enroll subjects who have previously participated in Study No. RN624-CL006. In this study, subjects will receive RN624 on an open-label basis.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: RN624 (PF-04383119)
Intervention descriptions: intervention 1: 50 mcg/kg

Protocol documents:
Clinical trial NCT00506389
Conditions: Insomnia
Keywords: Sleep Initiation and Maintenance Disorders, Sleep Disorders, Intrinsic Dyssomnias, Sleep Disorders, Nervous System Diseases, Mental Disorders
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-06-06; Completion date: 2008-02-13
Enrollment: 419 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to investigate the efficacy, safety and tolerability of esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia.

Detailed description:
Insomnia is a common complaint or disorder throughout the world. About one third of the population in the industrial countries reports difficulty initiating or maintaining sleep, resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer chronically from their complaints. It has been reported that in patients with chronic insomnia lasting longer than six months, 50% had a past or current mental disorder. This raises the possibility that treatment of insomnia may reduce the risk for psychological conditions. This double-blind, placebo-controlled, parallel, randomized clinical trial is designed to assess the efficacy and safety of esmirtazapine in patients suffering from chronic primary insomnia.

Arms: arm 1: Participants took placebo tablets on Days -7 and -6, esmirtazapine 3.0 mg tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening. arm 2: Participants took placebo tablets on Days -7 and -6, esmirtazapine 4.5 mg tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening. arm 3: Participants took placebo tablets on Days -7 and -6, placebo tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening.
Interventions: intervention 1: Esmirtazapine intervention 2: Placebo
Intervention descriptions: intervention 1: Esmirtazapine maleate was provided as tablets for oral use containing 3.0 mg, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia \[USP\] name corn starch), magnesium stearate, and lactose monohydrate. intervention 2: The placebo tablets contained the following excipients: hydroxypropyl cellulose, maize starch (USP name corn starch), magnesium stearate, and lactose monohydrate.

Protocol documents:
Clinical trial NCT00500331
Conditions: Diabetes Mellitus, Type 2
Keywords: Pioglitazone HbA1c Diabetes mellitus
Sponsor: GlaxoSmithKline
Start date: 2007-01-23; Completion date: 2008-02-14
Enrollment: 334 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a dose-ranging study that will evaluate the efficacy, safety and tolerability of a range of doses of investigational product and pioglitazone, compared to placebo, administered as monotherapy over 12 weeks in treatment naive patients with T2DM

Detailed description:

Arms: arm 1: GSK189075 arm 2: Placebo arm 3: pioglitazone (active control)
Interventions: intervention 1: GSK189075 intervention 2: pioglitazone intervention 3: Placebo
Intervention descriptions: intervention 1: Experimental Drug intervention 2: Active Control intervention 3: Placebo Comparator

Protocol documents:
Clinical trial NCT00282971
Conditions: Diabetes Mellitus Type 2
Keywords: Type 2 diabetes melllitus
Sponsor: Pfizer
Start date: 2006-03-06; Completion date: 2008-02-19
Enrollment: 354 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents

Detailed description:

Arms: arm 1: Inhaled insulin plus oral therapy arm 2: Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
Interventions: intervention 1: Inhaled Insulin (Exubera) intervention 2: Standard of Care
Intervention descriptions: intervention 1: Addition of inhaled insulin to pre-existing oral diabetes therapy. intervention 2: Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators

Protocol documents:
Clinical trial NCT00433147
Conditions: Gaucher Disease, Type 1 Type 1 Gaucher Disease Gaucher Disease
Keywords: afegostat tartrate isofagomine tartrate AT2101 Amicus Therapeutics
Sponsor: Amicus Therapeutics
Start date: 2007-03-23; Completion date: 2008-02-19
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was conducted to test the safety and tolerability of afegostat tartrate in participants with type 1 Gaucher disease already receiving enzyme replacement therapy.

Detailed description:
This was a Phase 2, open-label study in participants with Gaucher disease, a lysosomal storage disorder. Afegostat tartrate (also known as AT2101 or isofagomine tartrate) is designed to act as a pharmacological chaperone by selectively binding to misfolded β-glucocerebrosidase (GCase) and helping it fold correctly, intended to restore GCase activity. The study consisted of a 14-day screening period, a 28-day treatment period, and a 7-day wash-out period. Participants received 1 of 4 dosing regimens for afegostat tartrate.

Arms: arm 1: Afegostat tartrate was administered orally during the 4-week treatment period. arm 2: Afegostat tartrate was administered orally once per day during the 4-week treatment period. arm 3: Afegostat tartrate was administered orally once every 4 days during the 4-week treatment period. arm 4: Afegostat tartrate was administered orally once every 7 days during the 4-week treatment period.
Interventions: intervention 1: Afegostat tartrate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00517868
Conditions: Painful Bladder Syndrome Interstitial Cystitis Bladder Pain Syndrome
Keywords: bladder pain urgency frequency
Sponsor: Urigen
Start date: 2007-08-28; Completion date: 2008-02-28
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 compared to placebo.

Detailed description:

Arms: arm 1: Placebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2 arm 2: URG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2
Interventions: intervention 1: URG101 intervention 2: Placebo
Intervention descriptions: intervention 1: Bladder instillation of URG101 or Placebo in random order on treatment 1 and treatment 2 followed by an open-label URG101 on treatment 3 within the same week. intervention 2: Liquid formulation without active URG101 drug components

Protocol documents:
Clinical trial NCT00401375
Conditions: Post-Operative Ileus (POI)
Sponsor: Bausch Health Americas, Inc.
Start date: 2006-10-31; Completion date: 2008-02-29
Enrollment: 524 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and efficacy of MNTX in participants who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo regimen.

Detailed description:

Arms: arm 1: Participants will receive methylnaltrexone (MNTX) 12 milligrams (mg) as an intravenous (IV) infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug will be administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple is placed in the participant). arm 2: Participants will receive MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug will be administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple is placed in the participant). arm 3: Participants will receive placebo matching to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug will be administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple is placed in the participant).
Interventions: intervention 1: Methylnaltrexone intervention 2: Placebo
Intervention descriptions: intervention 1: Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms. intervention 2: Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arm.

Protocol documents:
Clinical trial NCT00080301
Conditions: Breast Cancer Metastases
Keywords: Metastatic Breast Cancer
Sponsor: R-Pharm
Start date: 2003-09-01; Completion date: 2008-03-01
Enrollment: 752 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemotherapy. The safety of this treatment will also be studied.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ixabepilone + Capecitabine intervention 2: Capecitabine
Intervention descriptions: intervention 1: Ixabepilone - Intravenous Solution, IV 40mg/m², Day 1 every 21 days, Until progression/unacceptable toxicity

Capecitabine (Active Comparator) - Tablet, Oral, 2000 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity intervention 2: Tablet, Oral, 2500 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity

Protocol documents:
Clinical trial NCT00082433
Conditions: Cancer Breast Cancer
Sponsor: R-Pharm
Start date: 2003-11-01; Completion date: 2008-03-01
Enrollment: 1221 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine alone in women with metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. The safety of this treatment will also be studied.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ixabepilone + Capecitabine intervention 2: Capecitabine
Intervention descriptions: intervention 1: Ixabepilone lypholized powder/Diluent for solution for injection/Tablets, IV/Oral, 40 mg/m2 + Capecitabine 2000 mg/m2, Ixabepilone on Day 1 and Capecitabine twice daily Days 1-14 of 21 day cycle intervention 2: Tablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle

Protocol documents: