ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01177228
Conditions: Ulcerative Colitis
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2007-05-01; Completion date: 2008-09-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objectives of this study were to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of vedolizumab in patients with ulcerative colitis (UC).

Detailed description:
At the end of the study, eligible participants could enroll and receive treatment and follow-up in Study C13004 (NCT00619489). Participants who did not proceed into Study C13004 were followed by telephone contact at 6-month intervals for 2 years after the last administration of study treatment to collect reports of adverse events, including colectomy, severe infections \[including progressive multifocal leukoencephalopathy (PML)\], and dysplasia/cancer.

Arms: arm 1: Vedolizumab-matching placebo, intravenous (IV), infusion on Days 1, 15, 29 and 85. arm 2: Vedolizumab, 2 mg/kg, IV infusion on Days 1, 15, 29 and 85. arm 3: Vedolizumab 6 mg/kg, IV infusion on Days 1, 15, 29 and 85. arm 4: Vedolizumab 10 mg/kg, IV infusion on Days 1, 15, 29 and 85.
Interventions: intervention 1: Vedolizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Vedolizumab for intravenous infusion intervention 2: Placebo intravenous infusion

Protocol documents:
Clinical trial NCT01263496
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy
Sponsor: Takeda
Start date: 2007-05-01; Completion date: 2008-09-01
Enrollment: 438 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the long-term safety and efficacy of SYR-322, once daily (QD), to an α-glucosidase inhibitor, three times daily (TID), administered for 40 consecutive weeks in participants who completed a phase 2 dose-ranging study.

Detailed description:
Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.

To evaluate the long-term safety and efficacy of alogliptin, this extension study was administered for 40 consecutive weeks (52 weeks from the start of treatment in the phase 2 dose-ranging study) to participants who had completed the phase 2 dose-ranging study SYR-322/CCT-001 (NCT01263470).

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Alogliptin intervention 2: Alogliptin intervention 3: Alogliptin intervention 4: Alogliptin intervention 5: Voglibose
Intervention descriptions: intervention 1: Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. intervention 2: Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. intervention 3: Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. intervention 4: Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. intervention 5: Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.

Protocol documents:
Clinical trial NCT01292226
Conditions: Kidney Transplantation
Sponsor: Hoffmann-La Roche
Start date: 2006-12-01; Completion date: 2008-09-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic parameters of CellCept in patients undergoing primary kidney transplantation, in order to assess the impact on clinical outcome and the risks of acute rejection. All patients will receive oral CellCept, 1g twice daily, and pharmacokinetic and pharmacodynamic parameters will be measured at weeks 2, 4, 12 and 24. The anticipated time on study treatment is 24 weeks.

Detailed description:

Arms: arm 1: Participants received an initial dose of mycophenolate mofetil (MMF), 1 gram (g), orally (PO), twice per day (BID), within 5 days of transplant for 24 weeks. Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
Interventions: intervention 1: mycophenolate mofetil intervention 2: antibody induction intervention 3: Cyclosporine intervention 4: corticosteroid
Intervention descriptions: intervention 1: 1 g PO BID for 24 weeks intervention 2: According to manufacturer recommendation intervention 3: According to manufacturer recommendation intervention 4: According to manufacturer recommendation

Protocol documents:
Clinical trial NCT01344369
Conditions: Healthy
Keywords: Healthy Subjects Bioequivalence
Sponsor: Teva Pharmaceuticals USA
Start date: 2008-08-01; Completion date: 2008-09-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study was to evaluate the relative bioavailability of a test formulation of norethindrone/ethinyl estradiol 0.4 mg/0.035 mg chewable tablets (Teva Pharmaceuticals, USA) compared to the reference listed product, FEMCON® Fe (norethindrone/ethinyl estradiol and ferrous fumarate) 0.4 mg/0.035 mg Chewable tablets (Warner Chilcott) under fed conditions in healthy, non-tobacco using, adult female subjects.

Detailed description:

Arms: arm 1: Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets (Teva) arm 2: FEMCON® Fe 0.4 mg/0.035 mg Chewable tablets (Warner Chilcott)
Interventions: intervention 1: Norethindrone/Ethinyl Estradiol intervention 2: FEMCON® Fe
Intervention descriptions: intervention 1: 0.4 mg/0.035 mg Chewable Tablets intervention 2: 0.4 mg/0.035 mg Chewable Tablets

Protocol documents:
Clinical trial NCT01804673
Conditions: Postoperative Pain
Keywords: Postoperative Pain Fentanyl Hydrochloride IONSYS
Sponsor: Janssen-Cilag G.m.b.H
Start date: 2008-03-01; Completion date: 2008-09-01
Enrollment: 174 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of the fentanyl iontophoretic transdermal (through the skin) system (fentanyl-ITS) in daily clinical practice for management of acute (a quick and severe form of illness in its early stage) moderate to severe post-operative pain (pain after surgery) including the comprehensibility and usefulness of the accompanying information material.

Detailed description:
This is an open label (all people know the identity of the intervention), single arm, and multi-center (when more than one hospital or medical school team work on a medical research study) study to evaluate safety and efficacy of the fentanyl-ITS for management of acute moderate to severe pain in post-operative participants' who have undergone elective surgery (surgery which could be postponed or not done at all without danger to the participant). The study will consists of 2 phases: screening phase (which comprises of pre-operative and post-operative stages) and an open label treatment phase. The participants will be treated with 40 microgram (mcg) of fentanyl transdermally per on-demand dose; each delivered over 10 minutes for a maximum of 6 doses (240 mcg) per hour for 24 hours and a maximum of 80 doses (3.2 milligram \[mg\]). Each system will inactivate at 80 doses or 24 hour, whichever occurs first. A new system will be applied every 24 hours unless the participant has used 80 doses in less than 24 hours. Maximum treatment duration of 72 hours is allowed. Participants will be expected to require parenteral (administration by injection) opioids (morphine like medications) for at least 24 hours post-operatively. This study will evaluate participant's, nurse's and physician's assessment of fentanyl-ITS under routine conditions. Participants' safety will be monitored throughout the study.

Arms: arm 1: None
Interventions: intervention 1: Fentanyl-ITS
Intervention descriptions: intervention 1: Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) will release fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment will be 72 hours.

Protocol documents:
Clinical trial NCT02004093
Conditions: Ovarian Cancer
Sponsor: Hoffmann-La Roche
Start date: 2005-12-01; Completion date: 2008-09-01
Enrollment: 149 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of pertuzumab in combination with carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian cancer. The anticipated time on study treatment is 3-12 months.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: pertuzumab intervention 2: paclitaxel intervention 3: gemcitabine intervention 4: carboplatin
Intervention descriptions: intervention 1: Loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks intervention 2: 175 mg/m2 IV every 3 weeks for 6 cycles intervention 3: 1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles intervention 4: Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles

Protocol documents:
Clinical trial NCT02071810
Conditions: Parkinson's Disease (PD)
Keywords: Parkinson's disease (PD) Opicapone Bial BIA 9-1067
Sponsor: Bial - Portela C S.A.
Start date: 2008-04-01; Completion date: 2008-09-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the tolerability of BIA 9-1067 after multiple rising dose regimens of BIA 9-1067.

Detailed description:
Single centre, double-blind, randomised, placebo-controlled study of four dosage regimens of BIA 9-1067 in four groups of healthy male volunteers. In each group, the study will consist of an once-daily (o.d.) 8-day multiple-dose period. Progression to the next dose level will only occur if the previous dose level was considered to be safe and well tolerated. An appropriate interval (will separate the investigation of doses to permit a timely review and evaluation of safety data prior to proceeding to a higher dose level.

Arms: arm 1: BIA 9-1067 (OPC, Opicapone) 5 mg arm 2: BIA 9-1067 (OPC, Opicapone) 10 mg arm 3: BIA 9-1067 (OPC, Opicapone) 20 mg arm 4: BIA 9-1067 (OPC, Opicapone) 30 mg arm 5: Placebo, PLC
Interventions: intervention 1: BIA 9-1067 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00584870
Conditions: Low Back Pain
Sponsor: Pfizer
Start date: 2007-07-05; Completion date: 2008-09-02
Enrollment: 220 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the analgesic efficacy of RN624 compared with placebo and compared with naproxen in the treatment of adult patients with chronic low back pain.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Naproxen intervention 2: Placebo intervention 3: PF-04383119 (RN624)
Intervention descriptions: intervention 1: Oral naproxen 500 mg twice daily for Weeks 1-12. intervention 2: Single IV infusion of placebo on Day 1 and placebo for naproxen twice daily for Weeks 1-12. intervention 3: Single IV infusion of 200 micrograms/kg RN624 on Day 1

Protocol documents:
Clinical trial NCT00428090
Conditions: Alzheimer's Disease
Keywords: apolipoprotein E monotherapy cognition mild rosiglitazone Alzheimer's disease moderate
Sponsor: GlaxoSmithKline
Start date: 2007-02-27; Completion date: 2008-09-05
Enrollment: 862 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Rosiglitazone (RSG) has been tested and is approved as a treatment for type II diabetes mellitus, a disease that occurs when the body ineffectively uses glucose. RSG XR, the investigational drug, is an extended-release form of RSG. This study tests whether RSG XR safely provides benefit to people with mild to moderate Alzheimer's disease (AD). RSG XR is a new approach to AD therapy and this study tests whether one's genes alter the effectiveness of RSG XR. Glucose is used by cells to make energy that they need to live. Changes in the ability of cells to use of glucose can lead to diseases like diabetes. Glucose levels may be lower in the brains of AD patients, and their brain cells may also use glucose less well than in unaffected people. The proper function of brain cells may be critical to memory and thought. If brain cells use glucose poorly, this might impact AD. Drugs that help brain cells properly use glucose may help a person maintain normal memory and thinking. Data suggesting that RSG may help AD patients was first seen in a small study at the Univ. of Washington and then from a larger international GSK study. In the first study, those receiving RSG once daily for 6 months scored better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that benefited most from therapy with RSG XR had a specific genetic pattern. They lacked the gene that caused them to produce apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent, or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE e3 version of the gene from one parent. Subjects with one copy of the APOE e4 gene remained fairly stable while those with two copies of APOE e4 continued to worsen during the 6-month treatment. This study will directly test the effect of RSG XR on people who either have or lack the APOE e4 gene.

Detailed description:
A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer's disease. (REFLECT-1)

Arms: arm 1: XR (extended release) oral tablets arm 2: Placebo (Double-Dummy to Match)
Interventions: intervention 1: Rosiglitazone
Intervention descriptions: intervention 1: XR (extended release) oral tablets

Protocol documents:
Clinical trial NCT00168298
Conditions: Macular Edema Retinal Vein Occlusion
Sponsor: Allergan
Start date: 2004-11-01; Completion date: 2008-09-05
Enrollment: 668 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.

Detailed description:

Arms: arm 1: 700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180. arm 2: 350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. arm 3: Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
Interventions: intervention 1: 700 µg Dexamethasone intervention 2: 350 µg Dexamethasone intervention 3: Sham Injection
Intervention descriptions: intervention 1: 700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180. intervention 2: 350 µg Dexamethasone intravitreal implant administered on Day 0. intervention 3: Sham injection on Day 0.

Protocol documents:
Clinical trial NCT00570128
Conditions: Down Syndrome
Keywords: Down Syndrome trisomy 21
Sponsor: Eisai Inc.
Start date: 2007-11-16; Completion date: 2008-09-05
Enrollment: 129 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether donepezil HCl is effective and safe in improving cognitive dysfunction exhibited by children and adolescents with Down syndrome (DS). Effectiveness will be measured by rating communication, daily living skills, and social skills and relationships in subjects aged 10 to 17.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Donepezil HCl intervention 2: Placebo
Intervention descriptions: intervention 1: Blinded donepezil 2.5 milligram per day (mg/day) (2.5 milliliter per day \[mL/day\]) orally for participants with body weight (BW) 20 and less than (\<) 25 kilogram (kg), 5 mg/day (5 mL/day) orally for participants with BW 25 to \<50 kg, and 10 mg/day (10 mL/day) orally for participants with BW greater than or equal to (\>=) 50 kg liquid formulation (1 milligram per 1 milliliter \[1 mg/1 mL\]) (titrated to 0.1 to 0.2 milligram per kilogram per day \[mg/kg/day\] based on BW). intervention 2: Liquid formulation matched to active treatment for oral administration.

Protocol documents:
Clinical trial NCT00624910
Conditions: Postoperative Pain
Keywords: Post Operative Pain Hysterectomy
Sponsor: Innocoll
Start date: 2007-12-27; Completion date: 2008-09-05
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after abdominal hysterectomy surgery.

Detailed description:
Hysterectomy is the second most common surgery among women in the United States (US). According to the National Center for Health Statistics, there were 617,000 hysterectomies performed in the US in 2004. Effective postoperative pain management after hysterectomy is important in ensuring that surgical subjects have a smooth and successful recovery after their operation. Morphine and other narcotic pain medications are often used to help control pain after hysterectomy, but the large quantities required can lead to fatigue, nausea and vomiting, as well as the inability to walk around much because of drowsiness. Reducing narcotic pain medication use can reduce these negative side effects.

Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery.

This study will compare the amount of narcotic pain medication required after surgery in patients who receive the CollaRx Bupivacaine implant, a plain collagen implant or no implant at all.

Arms: arm 1: A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure arm 2: A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure arm 3: The patient will recieve the standard of care, but no implant during surgery
Interventions: intervention 1: Bupivacaine Collagen Sponge (CollaRx®) intervention 2: placebo
Intervention descriptions: intervention 1: The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision. intervention 2: The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.

Protocol documents:
Clinical trial NCT00667004
Conditions: Dry Eye Disease
Sponsor: Bausch & Lomb Incorporated
Start date: 2008-03-22; Completion date: 2008-09-12
Enrollment: 183 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Efficacy study of ecabet ophthalmic solution in dry eye disease

Detailed description:

Arms: arm 1: ecabet ophthalmic solution arm 2: Placebo comparator
Interventions: intervention 1: ecabet ophthalmic solution intervention 2: placebo
Intervention descriptions: intervention 1: sterile ophthalmic solution intervention 2: sterile ophthalmic solution

Protocol documents:
Clinical trial NCT01585558
Conditions: Atrophy Vaginal Diseases
Keywords: Menopausal symptoms Urogenital atrophy Vulvar and vaginal atrophy in menopausal women Vaginal atrophy
Sponsor: Shionogi
Start date: 2006-05-16; Completion date: 2008-09-18
Enrollment: 180 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal women with an intact uterus.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Ospemifene (Dose 1) intervention 2: Ospemifene (Dose 2) intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00603746
Conditions: Asthma
Keywords: Adolescents Adults Asthma Pharmacokinetics Pharmacogenetics GW685698X
Sponsor: GlaxoSmithKline
Start date: 2007-12-01; Completion date: 2008-09-20
Enrollment: 627 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.

Detailed description:
A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder Twice Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma Symptomatic on Moderate-Dose ICS Therapy

Arms: arm 1: GW685698X
Interventions: intervention 1: GW685698X
Intervention descriptions: intervention 1: GW685698X

Protocol documents:
Clinical trial NCT00451035
Conditions: Chronic Myeloid Leukemia in Chronic Phase
Keywords: Refractory Chronic Myeloid Leukemia in Chronic Phase adults oral LBH589
Sponsor: Novartis Pharmaceuticals
Start date: 2007-02-19; Completion date: 2008-09-30
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic phase chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors

Detailed description:

Arms: arm 1: Participants were administered panobinostat 20 milligram (mg) orally once a day (OD) three times a week as part of a 4 week (28 day) treatment cycle. Panobinostat were administered at the same time each morning with 8oz/240 milliliter (ml) of water after a fasting period of at least two hours (water was allowed). Participants could continue treatment until they experienced unacceptable toxicity or disease progression.
Interventions: intervention 1: LBH589
Intervention descriptions: intervention 1: None

Protocol documents: