ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00863655
Conditions: Breast Cancer
Keywords: Breast Cancer Estrogen Receptor positive ER+ exemestane mTOR everolimus refractory NSAI
Sponsor: Novartis Pharmaceuticals
Start date: 2009-06-03; Completion date: 2014-12-04
Enrollment: 724 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
There are no treatments specifically approved after recurrence or progression on a non steroidal aromatase inhibitors (NSAI). In light of the need for new treatment options for postmenopausal women after failure of prior NSAI therapy, the purpose of this Phase III study is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane + placebo in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer refractory to NSAI.

Detailed description:

Arms: arm 1: Everolimus 10 mg daily in combination with exemestane 25 mg daily arm 2: Placebo of everolimus in combination with exemestane 25 mg daily
Interventions: intervention 1: Everolimus intervention 2: Exemestane intervention 3: Everolimus Placebo
Intervention descriptions: intervention 1: Everolimus was formulated as tablets of 5-mg strength and was packaged into blister packs . Everolimus (two 5 mg tablets daily) were administered in a blinded manner on their respective treatment arms by continuous oral daily dosing. intervention 2: Exemestane 25 mg orally daily. intervention 3: Placebo was formulated to be indistinguishable from the everolimus tablets. Matching placebo (two tablets daily) were administered in a blinded manner on their respective treatment arms by continuous oral daily dosing.

Protocol documents:
Clinical trial NCT01932762
Conditions: Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-10-01; Completion date: 2014-12-04
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-site, open-label trial evaluating the safety and efficacy of 100 mg of grazoprevir (MK-5172) used in combination with or without 50 mg of elbasvir (MK-8742) and/or ribavirin (RBV) in treating non-cirrhotic treatment-naïve participants with chronic genotype (GT) 2, 4, 5, and 6 hepatitis C infection.

In Part A there is no randomization or stratification; all GT2 participants will be assigned to arm A1. In Part B, all GT2 participants will be assigned to Arm B1 and all participants with GT4, GT5 and GT6 will be randomized in a 1:1 ratio to either Arm 3 or Arm 4 with stratification by genotype.

Detailed description:

Arms: arm 1: During Part A of the study, GT2 participants will receive 100 mg grazoprevir + 50 mg elbasvir + standard weight-based dosing of RBV for 12 weeks. arm 2: During Part B of the study, GT2 participants will receive 100 mg grazoprevir + standard weight-based dosing of RBV for 12 weeks. arm 3: During Part B of the study, GT4/GT5/GT6 participants will receive 100 mg grazoprevir + 50 mg elbasvir + standard weight-based dosing of RBV for 12 weeks. arm 4: During Part B of the study, GT4/GT5/GT6 participants will receive 100 mg grazoprevir + 50 mg elbasvir for 12 weeks.
Interventions: intervention 1: Grazoprevir intervention 2: Elbasvir intervention 3: Ribavirin
Intervention descriptions: intervention 1: 100 mg every day (QD) orally intervention 2: 50 mg QD orally intervention 3: Administered twice daily (BID) orally at a total daily dose of 800 mg to 1400 mg based on participant's weight on Day 1

Protocol documents:
Clinical trial NCT01611974
Conditions: Cytomegalovirus (CMV)
Keywords: transplant treatment resistant CMV refractory cytomegalovirus
Sponsor: Shire
Start date: 2012-07-17; Completion date: 2014-12-05
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess safety, antiviral activity, and pharmacokinetics of different doses of maribavir administered orally for up to 24 weeks for treatment of CMV infections that are resistant or refractory to treatment with ganciclovir/valganciclovir or foscarnet in recipients of stem cell or solid organ transplants.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Maribavir
Intervention descriptions: intervention 1: Tablet for oral administration

Protocol documents:
Clinical trial NCT01795859
Conditions: Chorea
Keywords: Huntington disease Chorea Tetrabenazine
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2013-08-05; Completion date: 2014-12-05
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether SD-809 tablets are effective in the treatment of chorea associated with Huntington's Disease.

Detailed description:
This is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety and tolerability of SD-809 for the treatment of chorea associated with Huntington's Disease. Approximately 90 subjects will be randomized (1:1) into the study, with approximately 45 subjects receiving SD-809 and 45 subjects receiving placebo. The study will be conducted at approximately 30 centers in the U.S. and Canada.

Arms: arm 1: SD-809 ER tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white). All are administered three times a day, with the 6 mg final dose is placebo. arm 2: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white). All are administered three times a day, with the 6 mg final dose is placebo.
Interventions: intervention 1: SD-809 intervention 2: Placebo
Intervention descriptions: intervention 1: SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white). intervention 2: Placebo tablets are identical in appearance to SD-809 tablets.

Protocol documents:
Clinical trial NCT02226562
Conditions: Dentin Sensitivity
Sponsor: GlaxoSmithKline
Start date: 2014-09-02; Completion date: 2014-12-05
Enrollment: 191 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to investigate the longitudinal efficacy of a potassium nitrate mouthwash formulation when used as an adjunct to brushing with a standard fluoride dentifrice for the relief of dentinal hypersensitivity (DH) compared to brushing with a standard fluoride dentifrice alone. This will be a single centre, eight week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth) study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at Baseline, and at four and eight weeks to monitor clinical efficacy and safety.

Detailed description:

Arms: arm 1: 3.0% weight by weight (w/w) potassium nitrate mouthwash with 0.02% sodium fluoride arm 2: Standard fluoride dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate (SMFP)
Interventions: intervention 1: Potassium nitrate and sodium fluoride intervention 2: Standard fluoride dentifrice
Intervention descriptions: intervention 1: 3.0% w/w potassium nitrate mouthwash with 0.02% sodium fluoride intervention 2: Standard fluoride dentifrice containing 1000 ppm fluoride as SMFP

Protocol documents:
Clinical trial NCT02232802
Conditions: Enoxaparin Sodium is Administered to Healthy Volunteers
Sponsor: Chemi S.p.A.
Start date: 2014-08-04; Completion date: 2014-12-05
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
* The primary objective of the trial is to assess the single-dose relative bioavailability of Chemi Enoxaparin (80 mg/0.8 mL) and Clexane® (80 mg/0.8 mL) administered by subcutaneous (s.c.) injection, under fasting conditions in healthy volunteers.
* The secondary objective of the trial is to assess safety and tolerability of Chemi Enoxaparin (80 mg/0.8 mL) and Clexane® (80 mg/0.8 mL) administered by s.c. injection, under fasting conditions in healthy volunteers.

Detailed description:
This is an open-label, randomised, single-dose, 2-way crossover study to determine the comparative bioavailability of enoxaparin sodium from the Chemi Enoxaparin s.c. (80 mg/0.8mL) with that from the reference IMP, Clexane® s.c. (80 mg/0.8mL), following single dose administration in healthy male and female subjects.

Each subject received each treatment over two separate treatment periods under fasting conditions. Each dosing day for male subjects will be separated by a washout period of at least 7 days. The study comprised a pre-study screen (within 14 days of the first dose), followed by 2 Treatment Periods (1 and 2). During each treatment period, subjects will reside at Simbec from the evening before dosing (Day 1), until at least 36 h post dose (evening of Day 2). On admission (Day -1), subjects will provide a urine sample for a drugs of abuse screen; this sample will also be tested to confirm a negative pregnancy result in female volunteers.

A single dose of the randomised treatment will be given on the morning of Day 1 following an overnight fast and blood PK/PD samples collected from pre-dose up to 36 h post dose (14 samples). Safety will also be evaluated at specified times throughout the study.

The post study visit will be conducted on Day 2 (36 h post-dose) of Treatment Period 2.

Arms: arm 1: Enoxaparin Sodium Chemi and Clexane will be administered to healthy subjects. Each subject will receive each treatment over two separate treatment periods under fasting conditions. arm 2: Enoxaparin Sodium Chemi and Clexane will be administered to healthy subjects. Each subject will receive each treatment over two separate treatment periods under fasting conditions.
Interventions: intervention 1: Enoxaparin Sodium intervention 2: Enoxaparin Sodium
Intervention descriptions: intervention 1: comparison of bioavailability of generic Enoxaparin Sodium and Clexane intervention 2: comparison of bioavailability of generic Enoxaparin Sodium and Clexane

Protocol documents:
Clinical trial NCT04032652
Conditions: Ulcerative Colitis
Keywords: Pharmacokinetics Aminosalicylates Mucosal levels Rectal dialysis
Sponsor: Endeavor Health
Start date: 2012-12-01; Completion date: 2014-12-05
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators plan to develop a novel method of estimating 5-ASA levels in the rectum at a mucosal level using in vivo rectal dialysis technique towards the eventual goal of determining the optimal dosing of Asacol® that would provide therapeutic levels of 5-ASA in the left colon.

Detailed description:
Asacol® is mesalazine in a pH-dependent tablet (Eudragit S) that remains intact until reaching the terminal ileum. The tablet dissolves at a pH 7 or greater, allowing mesalazine release in the terminal ileum and throughout the colon; hence, it would be anticipated that this form of 5-ASA will produce higher concentrations in the left colon in patients with active ulcerative colitis compared to other immediate release forms of 5-ASA. However, preliminary research using dynamic computer modeling and simulation predicted that patients with active ulcerative colitis (characterized by an increased stool frequency) treated with Asacol® and Lialda (another delayed release formulation) will achieve very low 5-ASA levels in the sigmoid colon and rectum. The model predicts that these 5-ASA preparations will be relatively ineffective in treating the left side of the colon in active ulcerative colitis.

Arms: arm 1: Rectal dialysis will be done after 1 week on 1200 mg asacol arm 2: Rectal dialysis will be done after 1 week on 2400 mg asacol
Interventions: intervention 1: Rectal dialysis intervention 2: Rectal dialysis
Intervention descriptions: intervention 1: Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels intervention 2: Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels

Protocol documents:
Clinical trial NCT02016716
Conditions: Postmenopausal Osteoporosis
Keywords: Postmenopausal Osteoporosis
Sponsor: Amgen
Start date: 2013-12-03; Completion date: 2014-12-08
Enrollment: 294 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.

Detailed description:
Upon confirmation of eligibility, participants were randomized in a 22:5:22:5 ratio to the following treatment groups:

* Romosozumab 90 mg/mL
* Placebo 90 mg/mL
* Romosozumab 70 mg/mL
* Placebo 70 mg/mL

After completing a 6-month treatment period, participants entered a 3-month follow-up period with an end of study (EOS) at month 9.

For the analysis of efficacy endpoints, the 2 placebo groups were combined into a single placebo group. For safety analyses, the data for placebo were presented separately for each group.

Arms: arm 1: Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous (SC) 1.17 mL injections of a 90 mg/mL solution, for 6 months. arm 2: Participants received matching placebo administered as 2 subcutaneous injections of 1.17 mL every month for 6 months. arm 3: Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1.0 mL injections of a 70 mg/mL solution, for 6 months. arm 4: Participants received matching placebo administered as 3 subcutaneous injections of 1.0 mL every month for 6 months.
Interventions: intervention 1: Romosozumab 90 mg/mL intervention 2: Placebo 90 mg/mL intervention 3: Romosozumab 70 mg/mL intervention 4: Placebo 70 mg/mL
Intervention descriptions: intervention 1: Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS). intervention 2: Placebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS. intervention 3: Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS. intervention 4: Placebo administered as 3 SC injections with the 1.0 mL glass PFS.

Protocol documents:
Clinical trial NCT01807221
Conditions: Heart Failure
Keywords: Heart Decompensation
Sponsor: Bayer
Start date: 2013-06-17; Completion date: 2014-12-09
Enrollment: 1066 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.

Detailed description:

Arms: arm 1: Oral - 2.5mg once daily (OD) for 30 days. Potential up-titration to 5mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days. arm 2: Oral - 5mg OD for 30 days. Potential up-titration to 10 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days. arm 3: Oral - 7.5mg OD for 30 days. Potential up-titration to 15 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days. arm 4: Oral - 10mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days. arm 5: Oral - 15mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days. arm 6: Oral - 25mg every other day (EOD). Potential up-titration to 25mg OD after 30 days and 50mg OD after 60 days.Placebo OD for 90 days.
Interventions: intervention 1: Finerenone (BAY94-8862) intervention 2: Placebo intervention 3: Inspra (eplerenone)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01241552
Conditions: Clostridium Difficile Infection
Keywords: Clostridium difficile recurrent Clostridium difficile vancomycin metronidazole monoclonal antibody Clostridium difficile infection (CDI)
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-10-10; Completion date: 2014-12-09
Enrollment: 1452 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate whether: 1) treatment with MK-3415A in addition to standard of care (SOC) antibiotic therapy will decrease Clostridium difficile infection (CDI) recurrence as compared to treatment with MK-6072 or MK-3415, 2) treatment with MK-3415A, MK-6072, or MK-3415, in addition to SOC antibiotic therapy will decrease CDI recurrence as compared to placebo, and 3) MK-3415A, MK-6072, and MK-3415 will be generally well tolerated in participants receiving SOC therapy for CDI as compared to placebo.

Detailed description:

Arms: arm 1: Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI arm 2: Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI arm 3: Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI arm 4: Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
Interventions: intervention 1: MK-3415 intervention 2: MK-6072 intervention 3: MK-3415A intervention 4: Placebo intervention 5: SOC
Intervention descriptions: intervention 1: A single IV infusion of MK-3415 (10 mg/kg of monoclonal antibody to Clostridium difficile Toxin A) intervention 2: A single infusion of MK-6072 (10 mg/kg of monoclonal antibody to Clostridium difficile Toxin B) intervention 3: A single IV infusion of MK-3415A (10 mg/kg of monoclonal antibody to Clostridium difficile Toxin A and 10mg/kg of monoclonal antibody to Clostridium difficile Toxin B) intervention 4: A single IV infusion of normal saline (0.9% sodium chloride) intervention 5: Standard of care (SOC) for CDI will be prescribed for 10 to 14 days and can begin on the day of study drug infusion; but the first dose must have been administered prior to or within a few hours following study drug infusion. SOC is defined as the receipt of oral metranidazole, oral vancomycin, IV metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV metronidazole.

Protocol documents:
Clinical trial NCT01427296
Conditions: Colon Cleansing
Keywords: Colon Cleansing Bowel Prep Colonoscopy
Sponsor: Bausch Health Americas, Inc.
Start date: 2011-09-16; Completion date: 2014-12-09
Enrollment: 2154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and efficacy of OsmoPrep tablets versus HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Polyethylene glycol intervention 2: Oral sodium phosphate solution
Intervention descriptions: intervention 1: HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L intervention 2: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L

Protocol documents:
Clinical trial NCT01609231
Conditions: Rectal Neoplasms
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-07-06; Completion date: 2014-12-09
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this adaptive trial is to compare the progression-free survival of participants with metastatic rectal carcinoma when treated with intravenous (IV) dalotuzumab (MK-0646) + irinotecan therapy relative to participants treated with IV cetuximab + irinotecan. The primary hypothesis is that administration of dalotuzumab in combination with irinotecan to participants with wild-type KRAS metastatic rectal carcinoma with high insulin growth factor (IGF)-1/low IGF-2 expression levels improves progression-free survival compared to patients treated with cetuximab in combination with irinotecan.

Detailed description:

Arms: arm 1: Participants receive irinotecan intravenously (IV), 180 mg/m\^2 once every two weeks + dalotuzumab IV, 10 mg/kg once weekly, during ≥1 42-day treatment cycle(s). arm 2: Participants receive cetuximab IV, initial dose of 400 mg/m\^2 and then 250 mg/m\^2 IV weekly + irinotecan IV, 180 mg/m\^2 once every two weeks, during ≥1 42-day treatment cycle(s).
Interventions: intervention 1: Dalotuzumab intervention 2: Irinotecan intervention 3: Cetuximab
Intervention descriptions: intervention 1: Dalotuzumab will be administered intravenously after the completion of irinotecan infusion at a dose of 10 mg/kg once weekly. intervention 2: Irinotecan 180 mg/m\^2 will be administered intravenously once every two weeks either prior to dalotuzumab (Arm A) or after cetuximab (Arm B). Pre-medication at the discretion of the investigator will follow local or country-specific standard of care. intervention 3: Cetuximab will be administered intravenously prior to irinotecan at an initial dose of 400 mg/m\^2 followed by weekly infusions of 250 mg/m\^2. Pre-medication at the discretion of the investigator will follow local or country-specific standard of care.

Protocol documents:
Clinical trial NCT02015637
Conditions: Gonorrhea
Keywords: Gonorrhea N. gonorrhoeae bacterial infection Anti-Infective Agents Anti-Bacterial Agents
Sponsor: Melinta Therapeutics, Inc.
Start date: 2014-01-23; Completion date: 2014-12-10
Enrollment: 460 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of a single oral dose of delafloxacin versus a single intramuscular injection of ceftriaxone in subjects with uncomplicated cervical, urethral, rectal, or pharyngeal gonorrhea.

Detailed description:

Arms: arm 1: 900mg orally (2 x 450 mg tablets) administered once arm 2: Ceftriaxone 250 mg intramuscular injection administered once
Interventions: intervention 1: Delafloxacin intervention 2: Ceftriaxone
Intervention descriptions: intervention 1: single dose intervention 2: single dose

Protocol documents:
Clinical trial NCT01818141
Conditions: Clostridium Difficile Infection
Sponsor: Hartford Hospital
Start date: 2012-10-17; Completion date: 2014-12-15
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare number of vegetative cells and spores in stool over time for fidaxomicin or vancomycin in patients diagnosed with their first episode of C. difficile infection.

Detailed description:
The purpose of this study is to:

* Compare quantitatively the number of vegetative cells in stool over time for fidaxomicin or vancomycin in patients diagnosed with their first episode of C. difficile infection
* Compare quantitatively the number of spores in the stool over time for patients presenting with their first episode of C. difficile infection having been treated with either fidaxomicin or vancomycin.

Arms: arm 1: Fidaxomicin 200mg by mouth every 12 hours for 10 days arm 2: Vancomycin 125mg by mouth every 6 hours for 10 days
Interventions: intervention 1: Vancomycin intervention 2: Fidaxomicin
Intervention descriptions: intervention 1: Vancomycin 125mg by mouth every 6 hours for 10 days intervention 2: Fidaxomicin 200mg by mouth every 12 hours for 10 days

Protocol documents: