ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02093026
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2002-08-01; Completion date: 2012-12-01
Enrollment: 465 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the long-term safety and efficacy of repeat treatment courses of rituximab, in combination with methotrexate in a disease-modifying anti-rheumatic drug (DMARD) inadequate responder population of participants who were previously randomized into studies WA16291 (NCT02693210) or WA17043/U2644g (NCT00074438). The study permits multiple re-treatments until the protocol-defined end-of-treatment date (31 December 2011). Participants will then enter a safety follow-up (SFU) period of at least 48 weeks. This will provide at least 7 years follow-up data on all participants initially randomized into WA16291 or WA17043/U2644g. Approximately 600 participants will potentially be eligible to enter this open label extension study from their respective feeder studies.

Detailed description:

Arms: arm 1: Participants will receive rituximab 1 gram intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants will receive methotrexate 10-25 milligrams per week (mg/week) orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid greater than or equal to (\>=) 5 mg/week or equivalent. Participants will receive retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment will be based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab will be continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever is sooner.
Interventions: intervention 1: Rituximab intervention 2: Methotrexate intervention 3: Methylprednisolone intervention 4: Folic Acid
Intervention descriptions: intervention 1: Participants will receive rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. intervention 2: Participants will receive methotrexate 10-25 mg/week orally or parenterally. intervention 3: Participants will receive methylprednisolone 100 mg IV 30 minutes prior to each rituximab infusion. intervention 4: Participants will receive folic acid \>= 5 mg/week or equivalent.

Protocol documents:
Clinical trial NCT02291510
Conditions: Healthy Subjects
Sponsor: Elcelyx Therapeutics, Inc.
Start date: 2012-10-01; Completion date: 2012-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study compared the pharmacokinetics (PK) and assessed the safety of delayed-release metformin (Met DR, EFB0027) at two dosage levels, immediate-release metformin (Met IR, ETB0015), and extended-release metformin (Met XR, ETB0014) in healthy subjects.

Detailed description:

Arms: arm 1: Two doses of 500 mg metformin delayed-release arm 2: Two doses of 1000 mg metformin delayed-release arm 3: Two doses of 1000 mg metformin immediate-release arm 4: Single dose of 2000 mg metformin extended-release
Interventions: intervention 1: Met DR intervention 2: Met XR intervention 3: Met IR
Intervention descriptions: intervention 1: metformin delayed-release tablets intervention 2: metformin extended-release tablets intervention 3: metformin immediate-release tablets

Protocol documents:
Clinical trial NCT02987868
Conditions: Growth Hormone Treatment Aging
Keywords: Somatostatin Thyroid Hormone Growth Hormone
Sponsor: Pennington Biomedical Research Center
Start date: 2011-10-01; Completion date: 2012-12-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
In a recent randomized, double-blind, cross-over clinical trial, serum growth hormone (hGH) increased 682% above baseline 120 minutes after oral administration of an amino acid-based dietary supplement (SeroVital), p=0.01 vs placebo. In contrast to the mechanism of hGH stimulation by ghrelin, the investigators hypothesize that the supplement suppresses somatostatin, a know inhibitor of both hGH and TSH. To test this hypothesis, the investigators measured triiodothyronine (T3) after administration of the amino acid-base supplement.

Detailed description:
Two molecular targets that regulate the synthesis and secretion of human growth hormone (hGH) include 1) ghrelin, an endogenous ligand secreted by the stomach that also has appetite-stimulation properties distinct from its hGH-stimulating effects, and 2) somatostatin, a family of 14 and 28 amino acid peptides that act as a potent noncompetitive inhibitor of the release of hGH. the investigators recently reported that oral administration of a 2.9g/dose of SeroVital, a blend of l-lysine HCl, l-arginine HCL, oxo-proline, N-acetyl-l-cysteine, l-glutamine, and schizonepeta (aerial parts) powder, leads to a significant 682% mean increase in endogenous hGH levels in male and female subjects in a period of 120 minutes following acute consumption. In the work presented here, the investigators seek to characterize the mechanistic target associated with this measured increase in endogenous hGH by SeroVital, which the investigators hypothesize to be somatostatin. The investigators test this hypothesis by assaying thyroid function, a secondary inhibition target of somatostatin. The investigators further compare our findings to ghrelin-based hGH secretagogues.

Arms: arm 1: Administration of oral supplement (proprietary amino acid derivative blend). Half of the participants took the Amino acid supplement first day and half of the participants took the Amino acid supplement second day. arm 2: Half of the participants took the placebo first day and half of the participants took placebo second day.
Interventions: intervention 1: Amino acid supplement first day intervention 2: Placebo first day intervention 3: Amino acid supplement second day intervention 4: Placebo second day
Intervention descriptions: intervention 1: An orally administered supplement of the proprietary amino acid derivative intervention 2: A non-active orally administered supplement of the proprietary amino acid derivative intervention 3: An orally administered supplement of the proprietary amino acid derivative intervention 4: A non-active orally administered supplement of the proprietary amino acid derivative

Protocol documents:
Clinical trial NCT01318642
Conditions: Adenocarcinoma of the Pancreas Locally Advanced Unresectable
Keywords: Adenocarcinoma pancreas pancreatic cancer local unresectable stage II stage III
Sponsor: NantBioScience, Inc.
Start date: 2012-05-31; Completion date: 2012-12-03
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will be randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo. Randomization will be stratified by ECOG (0 or 1).

Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of every 28 day cycle. Treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.

Detailed description:
This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will be randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo. Randomization will be stratified by ECOG (0 or 1).

Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of every 28 day cycle. Treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.

Arms: arm 1: Arm 2: AMG479-placebo IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle arm 2: ARM 1: AMG 479 20mg/kg IV days 1 and 15 plus gemcitabine 1000mg/m2 IV days 1, 8, and 15 of a 28 day cycle.
Interventions: intervention 1: Gemcitabine intervention 2: AMG 479 intervention 3: Placebo
Intervention descriptions: intervention 1: Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle. intervention 2: Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle. intervention 3: Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle

Protocol documents:
Clinical trial NCT01455597
Conditions: Vulvovaginal Atrophy
Keywords: Postmenopausal Women Vaginal Dryness Postmenopausal Vulvovaginal Atrophy
Sponsor: Warner Chilcott
Start date: 2011-10-20; Completion date: 2012-12-03
Enrollment: 309 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label extension study evaluating the long-term safety and efficacy of WC3011 in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.

Detailed description:

Arms: arm 1: WC3011 estradiol vaginal cream 3 times a week for up to 40 weeks.
Interventions: intervention 1: WC3011 Estradiol Vaginal Cream
Intervention descriptions: intervention 1: WC3011 estradiol vaginal cream, 3 times a week for 40 weeks.

Protocol documents:
Clinical trial NCT01477853
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-10-24; Completion date: 2012-12-04
Enrollment: 166 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This two-phase study was to examine if 16 weeks of treatment with sitagliptin in combination with atorvastatin reduces hemoglobin A1C (A1C) and low density lipoprotein cholesterol (LDL-C) from baseline more than atorvastatin alone and sitagliptin alone, respectively. Following a single-blind placebo run-in period, participants were to be randomized to one of three treatment arms (sitagliptin monotherapy, atorvastatin monotherapy, or sitagliptin plus atorvastatin) for 16 weeks (Phase A). During Phase B of the study (Weeks 16 through 54), participants were to receive either sitagliptin plus atorvastatin or glimepiride plus atorvastatin. The primary hypotheses were that after 16 weeks of treatment, sitagliptin in combination with atorvastatin reduces A1C from baseline more than atorvastatin alone, and that atorvastatin in combination with sitagliptin lowers LDL-C from baseline more than sitagliptin alone.

Detailed description:

Arms: arm 1: In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks. arm 2: In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks. arm 3: In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
Interventions: intervention 1: Sitagliptin intervention 2: Atorvastatin intervention 3: Placebo to sitagliptin intervention 4: Placebo to atorvastatin intervention 5: Metformin (open-label) intervention 6: Glimepiride (open-label) intervention 7: Glimepiride (double-blind) intervention 8: Placebo to glimepiride
Intervention descriptions: intervention 1: Sitagliptin 100 mg tablet orally daily intervention 2: Atorvastatin 80 mg tablet orally daily intervention 3: Placebo to sitagliptin tablet orally daily intervention 4: Placebo to atorvastatin tablet orally daily. intervention 5: Participant will remain on prestudy dose of metformin tablets (at least 1500 mg daily) throughout entire study. intervention 6: Phase A: Glimepiride 1 or 2 mg tablet once daily with breakfast or the first main meal of the day (titrated up to 6 mg/day) for 16 weeks as rescue therapy for randomized participants not meeting specific glycemic goals. intervention 7: Phase B: glimepiride up to 6 mg daily for participants not rescued with open-label glimepiride during Phase A. intervention 8: Phase B: placebo to glimepiride tablet orally daily.

Protocol documents:
Clinical trial NCT01307033
Conditions: Hypertension
Keywords: Essential hypertension Uncontrolled hypertension Antihypertensive agents Blood pressure
Sponsor: Organon and Co
Start date: 2011-03-29; Completion date: 2012-12-04
Enrollment: 278 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to evaluate the safety of MK-0954A (L100/H12.5 mg) in essential hypertension participants who are uncontrolled with MK-954H (L50/H12.5 mg).

Detailed description:

Arms: arm 1: One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension) arm 2: One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension
Interventions: intervention 1: MK-0954A intervention 2: MK-954H intervention 3: Placebo to MK-0954A intervention 4: Placebo to MK-954H
Intervention descriptions: intervention 1: Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily intervention 2: Tablet containing losartan potassium (50 mg) and hydrochlorothiazide (12.5 mg), once daily intervention 3: Placebo tablet to match MK-0954A, once daily intervention 4: Placebo tablet to match MK-954H, once daily

Protocol documents:
Clinical trial NCT01437111
Conditions: Osteoporosis
Keywords: Osteoporosis Postmenopausal
Sponsor: Organon and Co
Start date: 2011-10-26; Completion date: 2012-12-05
Enrollment: 200 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the effect of 26 weeks of once-weekly treatment with MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600) on serum levels of 25-hydroxyvitamin D \[25(OH)D\].

Detailed description:

Arms: arm 1: Calcium supplement (elemental calcium and/or calcium carbonate) without vitamin D will also be supplied to participants
Interventions: intervention 1: MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet
Intervention descriptions: intervention 1: One combination tablet orally once a week

Protocol documents:
Clinical trial NCT01490190
Conditions: Contraception
Sponsor: Organon and Co
Start date: 2011-12-26; Completion date: 2012-12-05
Enrollment: 252 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will collect information on cycle control, acceptability and tolerability of the vaginal contraceptive ring (NuvaRing) as used in normal daily practice by Indian women.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing)
Intervention descriptions: intervention 1: Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.

Protocol documents:
Clinical trial NCT00910624
Conditions: Hepatitis C, Chronic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-06-22; Completion date: 2012-12-07
Enrollment: 168 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single-arm, multicenter study of boceprevir (BOC) in combination with peginterferon plus ribavirin (PEG/RBV) in adult chronic hepatitis C (CHC) genotype 1 participants who completed their per-protocol defined treatment and did not achieve sustained viral response (SVR) while in the PEG/RBV control arm(s) of an Schering-Plough Research Institute (SPRI) study of BOC combination therapy. Participants who are able to enroll in this study within 2 weeks after the last dose of PEG/RBV in previous protocol are to receive BOC+ PEG/RBV for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who are not able to enroll in this study within 2 weeks after the last dose of PEG/RBV in previous protocol are to receive PEG/RBV for 4 weeks followed by BOC+ PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.

Detailed description:

Arms: arm 1: Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous protocol received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
Interventions: intervention 1: Boceprevir intervention 2: Peginterferon alfa-2b (SCH 54031) intervention 3: Ribavirin (SCH 18908)
Intervention descriptions: intervention 1: Boceprevir, 200-mg capsules, 800 mg three times a day (TID) orally (PO) intervention 2: Peginterferon alfa-2b 1.5 µg/kg/week subcutaneously (SC) intervention 3: Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day PO divided twice daily (BID).

Protocol documents:
Clinical trial NCT01124149
Conditions: Ulcerative Colitis
Sponsor: Shire
Start date: 2010-06-29; Completion date: 2012-12-07
Enrollment: 759 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study was designed to evaluate if subjects who achieve complete remission after 8 weeks of acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD have better long-term outcomes and remain in remission longer compared with subjects who demonstrate only partial remission after acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD. Therefore, subjects who achieve either complete or partial remission will enter into a 12-month maintenance phase, during which they will receive MMX mesalamine/mesalazine 2.4g/day given QD. Remission status for the 2 groups will be evaluated and compared at the end of this 12-month maintenance period. The data obtained from this study will provide scientifically meaningful information to demonstrate that achieving complete remission (clinical and endoscopic remission) is important for a better long-term prognosis, or that the current paradigm of symptomatic treatment is appropriate.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: MMX mesalamine/ mesalazine
Intervention descriptions: intervention 1: 4.8g/day given QD (four 1.2g tablets) for 8 weeks, 2.4g/day given QD (two 1.2g tablets) for 12 months

Protocol documents:
Clinical trial NCT00486824
Conditions: Obstetric Labor, Premature
Sponsor: Stanford University
Start date: 2007-04-01; Completion date: 2012-12-08
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Indomethacin and Nifedipine are commonly used medications for treatment of pre term labor. This study will compare the efficacy and adverse outcomes of oral nifedipine versus oral indomethacin for preterm labor tocolysis in an effort to identify which drug is most effective.

Patients diagnosed with preterm labor who grant consent will be randomized by the pharmacy to receive oral nifedipine or oral indomethacin. Both the patient and primary medical provider will be blinded to the identity of the study drug. An abdominal ultrasound will be performed in the labor and delivery unit prior to the administration of the tocolytic in order to assess fetal position and fluid level, and to document fetal cardiac activity and movement, and will be repeated at 48 hours post-randomization. Following randomization, the patient will be given either 50 mg oral indomethacin with two pills of placebo, or 3 pills each containing 10 mg oral nifedipine for a total of 30 mg. The patients will then receive either 25 mg of oral indomethacin every 6 hours for 48 hours, or 20 mg of oral nifedipine every 6 hours for 48 hours. Tocolysis beyond 48 hours will not be used.

Detailed description:
Patients presenting between 24-34 weeks gestation diagnosed with preterm labor who grant consent will be randomized by the pharmacy to receive oral nifedipine or oral indomethacin. Both the patient and primary medical provider will be blinded to the identity of the study drug. An abdominal ultrasound will be performed in the labor and delivery unit prior to the administration of the tocolytic in order to assess fetal position and fluid level, and to document fetal cardiac activity and movement, and will be repeated at 48 hours post-randomization. Following randomization, the patient will be given either 50 mg oral indomethacin with two pills of placebo, or 3 pills each containing 10 mg oral nifedipine for a total of 30 mg. The patients will then receive either 25 mg of oral indomethacin every 6 hours for 48 hours, or 20 mg of oral nifedipine every 6 hours for 48 hours. Tocolysis beyond 48 hours will not be used. Antibiotics and steroids for fetal lung maturity will be administered as per standard of care for preterm labor. Maternal side effects and delivery outcomes will be assessed from questionnaires administered by the study team following treatment, and/or from review of the patient's medical records.

Arms: arm 1: 50 mg. oral Indomethacin initially, followed by 25 mg every 6 hrs for 48 hrs. arm 2: 30 mg Nifedipine initially followed by 20 mg every 6 hrs for 48 hrs.
Interventions: intervention 1: Indomethacin intervention 2: Nifedipine
Intervention descriptions: intervention 1: One 50 mg tablet of Indomethacin plus 2 pills of placebo followed by one 25 mg tablet of oral indomethacin every 6 hrs for 48 hrs. intervention 2: Three 10 mg tablets of Nifedipine followed by one 20 mg tablet every 6 hrs for 48 hrs.

Protocol documents: