ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02295280
Conditions: Headache
Keywords: headache
Sponsor: St. Louis University
Start date: 2012-01-01; Completion date: 2014-11-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine if the intravenous administration of Metoclopramide and diphenhydramine in combination can effectively treat headaches in pregnant patients in those refractory to acetaminophen when compared to codeine

Detailed description:
This is a randomized, controlled study based on prospective collection of data during the study subjects' hospital stays, questioning at 30 minutes and 1, 6, and 24 hours after administration, and a post-study questionnaire at 24 hours. Subjects who agree to participate in the study will have already tried a standard effective dose of acetaminophen (650 to 1000mg) without relief and are requesting further medication. Intravenous (IV) access will be obtained and administration of 10mg Metoclopramide IV and 25mg Diphenhydramine IV drawn up in the same syringe will be given to subjects randomized to Group A, while those randomized to Group B (control group) will receive standard treatment consisting of a codeine 30mg tablet. Each subject will be asked if they had relief or persistence/recurrence of symptoms at 30 minutes, 1 hour and 6 hours after initial receipt of study medications. An additional dose of 10 mg IV metoclopramide + 25 mg IV diphenhydramine or codeine 30 mg tablets would be given at one hour if the patient did not have adequate relief the first time. If headache does not subside or recurs after second dose, regular non protocol medicines may be administered upon doctor recommendation. Patients will again be asked about headache at 24 hours and asked to complete a questionnaire regarding tolerance of medication, any adverse reactions experienced, persistence/recurrence of headache after administration of study medication, timing of occurrence with regard to administration, requirements of a second dose of study medication or other use of headache or nausea medication not included in protocol, satisfaction or relief of headache on a Likert scale from 0 to 10 after administration of medication if given at 1 hr interval.

Randomization Subjects will be randomized to GROUP A or GROUP B. An order will be placed to the SMHC pharmacy for the respective Group and will send up the medication assigned. The pharmacy will know which medications are in Group A and which are in Group B. On the pharmacy order sheet, the research team will indicate which group each subject is randomized to. The pharmacy will supply the medications and one of the nurses on the 5th floor will administer them.

Arms: arm 1: Intravenous (IV) access will be obtained and administration of 10mg Metoclopramide IV and 25mg Diphenhydramine IV Group A arm 2: Group B (control group) will receive standard treatment consisting of a codeine 30mg tablet.
Interventions: intervention 1: Metoclopramide intervention 2: Diphenhydramine intervention 3: Codeine
Intervention descriptions: intervention 1: IV intervention 2: iv intervention 3: PO

Protocol documents:
Clinical trial NCT02298868
Conditions: Muscle Cramps Cirrhosis
Sponsor: University of Virginia
Start date: 2012-10-01; Completion date: 2014-11-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety and efficacy of the medication Baclofen for treatment of muscle cramps in patients with cirrhosis.

Detailed description:

Arms: arm 1: All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
Interventions: intervention 1: Baclofen
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02301169
Conditions: Peripheral Neuropathies
Keywords: Pain
Sponsor: Tools4Patient
Start date: 2014-03-01; Completion date: 2014-11-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical trial conducted in patients suffering from chronic pain is to study the relationship between individual patients' profile and their analgesic response.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Heat pain stimuli A intervention 2: Video A intervention 3: Administration of T4P1001 capsules intervention 4: Heat pain stimuli B intervention 5: Video B intervention 6: Administration of placebo capsules
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: This treatment is given as add on therapy to patients' regular analgesic intervention 4: None intervention 5: None intervention 6: This treatment is given as add on therapy to patients' regular analgesic

Protocol documents:
Clinical trial NCT02458768
Conditions: Infertility, Female
Sponsor: LG Life Sciences
Start date: 2013-07-01; Completion date: 2014-11-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study was to demonstrate the non-inferiority of IVFM HP Inj. by evaluating its efficacy versus Menopur® Inj. in infertility women undergoing the in vitro fertilization and embryo transfer (IVF-ET) among the assisted reproductive technologies.

Detailed description:

Arms: arm 1: administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.

Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results). arm 2: administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.

Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).
Interventions: intervention 1: IVF-M HP Inj. intervention 2: Menopur® Inj.
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02632812
Conditions: Gastrointestinal Lesions
Sponsor: Biolab Sanus Farmaceutica
Start date: 2014-10-01; Completion date: 2014-11-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double-blind, placebo-controlled, randomized, parallel trial to evaluate if rebamipide reduces the number of gastric events caused by naproxen. Sample size is 24 participants (12 per treatment group), male or female, aged 18 years-old and above.

Primary objective is to compare rebamipide effervescent granules 100 mg twice daily, plus naproxen (coated tablets) 550 mg twice daily to placebo plus naproxen 550 mg twice daily, for seven days, in reduction of gastric events caused by naproxen. Secondary objective is to evaluate safety and tolerability of rebamipide after multiple administrations.

Participants will receive either rebamipide + naproxen or placebo + naproxen, as above, during 7 consecutive days, which will be accompanied by a follow-up visit.

Gastric integrity will be assessed, before and after treatment, by endoscopy, with stomach biopsies and detection of H. pylori. Additionally, detection of occult blood in the stool will be performed, before and after treatment.

From the above-mentioned biopsies, dosage of prostaglandin E2 and histopathological analysis will be performed.

Detailed description:

Arms: arm 1: Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days arm 2: Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days
Interventions: intervention 1: Rebamipide effervescent granules intervention 2: Placebo effervescent granules intervention 3: Naproxen tablet
Intervention descriptions: intervention 1: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days intervention 2: Placebo effervescent granules (oral), twice daily for 7 days intervention 3: Naproxen tablet 550mg (tablet), twice daily for 7 days

Protocol documents:
Clinical trial NCT01594749
Conditions: Chemotherapy-Induced Nausea and Vomiting (CINV)
Keywords: NK-1 Receptor Antagonist, CINV, Emesis, MEC
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-09-24; Completion date: 2014-11-03
Enrollment: 1015 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to demonstrate that, when given concomitantly with a 5-hydroxytryptamine 3 (5-HT3) antagonist and a corticosteroid, a single 150 mg intravenous (IV) dose of fosaprepitant given on Day 1 is superior to the control regimen of 5-HT3 antagonist and corticosteroid only, in preventing chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC).

Detailed description:

Arms: arm 1: On Day 1, participants received fosaprepitant, 150 mg intravenous (IV) infusion, \~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, orally (PO) \~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO \~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO \~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone. arm 2: On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, \~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO \~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO \~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
Interventions: intervention 1: Fosaprepitant dimeglumine intervention 2: Fosaprepitant Placebo intervention 3: Dexamethasone intervention 4: Ondansetron intervention 5: Dexamethasone Placebo intervention 6: Ondansetron Placebo intervention 7: Rescue Therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None

Protocol documents:
Clinical trial NCT01336608
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: GlaxoSmithKline
Start date: 2011-03-04; Completion date: 2014-11-04
Enrollment: 446 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to investigate the effect of fluticasone furoate/vilanterol Inhalation Powder on arterial stiffness compared with placebo and vilanterol over a 24-week treatment period in subjects with COPD and aortic pulse wave velocity of 11.0 m/s or above.

Detailed description:

Arms: arm 1: Inhaled corticosteroid/long acting beta-agonist arm 2: Inhaled long acting beta-agonist arm 3: Placebo
Interventions: intervention 1: Fluticasone Furoate/Vilanterol intervention 2: Vilanterol intervention 3: Placebo
Intervention descriptions: intervention 1: Inhaled corticosteroid/long acting beta-agonist intervention 2: Inhaled long acting beta-agonist intervention 3: Placebo

Protocol documents:
Clinical trial NCT01427751
Conditions: Retinal Vein Occlusion Macular Edema
Sponsor: Allergan
Start date: 2011-10-11; Completion date: 2014-11-04
Enrollment: 307 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion (BRVO).

Detailed description:

Arms: arm 1: Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter. arm 2: Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria.
Interventions: intervention 1: dexamethasone intravitreal implant intervention 2: ranibizumab
Intervention descriptions: intervention 1: Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter. intervention 2: Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria.

Protocol documents:
Clinical trial NCT01952145
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2013-09-20; Completion date: 2014-11-04
Enrollment: 557 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted globally. The aim of the trial is to compare the efficacy and safety of insulin degludec/liraglutide versus insulin glargine in subjects with type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec/liraglutide intervention 2: insulin glargine
Intervention descriptions: intervention 1: Insulin degludec/liraglutide is injected subcutaneously s.c. (under the skin) once daily (OD). Dose individually adjusted. Subjects should continue their pre-trial treatment with metformin. intervention 2: Insulin glargine is injected subcutaneously s.c. (under the skin) once daily (OD). Dose individually adjusted. Subjects should continue their pre-trial treatment with metformin.

Protocol documents:
Clinical trial NCT02109445
Conditions: Metastatic Cancer Pancreas
Sponsor: Pfizer
Start date: 2014-09-03; Completion date: 2014-11-06
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
This study consists of a Phase 1b portion aimed to determine the maximum tolerated dose and the safety profile of PF-03084014 in combination with gemcitabine and nab-paclitaxel followed by a Phase 2 portion to evaluate the efficacy of the triple combination in terms of overall survival in patients with metastatic pancreatic ductal adenocarcinoma not previously treated with anticancer therapies.

Detailed description:

Arms: arm 1: PF-03084014 in combination with gemcitabine and nab-paclitaxel arm 2: PF-03084014 in combination with gemcitabine and nab-paclitaxel arm 3: Gemcitabine plus nab-Paclitaxel
Interventions: intervention 1: PF-03084014 intervention 2: Gemcitabine intervention 3: Nab-paclitaxel intervention 4: PF-03084014 intervention 5: Gemcitabine intervention 6: Nab-paclitaxel intervention 7: Gemcitabine intervention 8: Nab-paclitaxel
Intervention descriptions: intervention 1: Tablets, orally administered twice daily on a continuous dosing schedule in 28 days cycles. Doses: 100 -150 mg BID intervention 2: Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 1000 mg/m2. intervention 3: Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 125 mg/m2. intervention 4: Tablets, orally administered twice daily on a continuous dosing schedule in 28 days cycles. Phase 2 dose will be the recommended phase 2 dose defined in phase 1. intervention 5: Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 1000 mg/m2. intervention 6: Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 125 mg/m2. intervention 7: Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 1000 mg/m2. intervention 8: Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 125 mg/m2.

Protocol documents:
Clinical trial NCT01835431
Conditions: Diabetes Diabetes Mellitus, Type 1
Sponsor: Novo Nordisk A/S
Start date: 2013-10-17; Completion date: 2014-11-07
Enrollment: 362 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals in children and adolescents with type 1 diabetes mellitus.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec/insulin aspart intervention 2: insulin aspart intervention 3: insulin detemir intervention 4: insulin aspart
Intervention descriptions: intervention 1: Administered subcutaneously (s.c., under the skin) once daily with a main meal. Dose individually adjusted. intervention 2: Administered s.c. with the remaining meals. Dose individually adjusted. intervention 3: Administered s.c. once or twice daily. Dose individually adjusted. Subjects will continue with their pre-trial dosing scheme (once (OD) or twice daily (BID)) and will be allowed to switch from OD to BID dosing. intervention 4: Administered s.c. at meal-times. Dose individually adjusted.

Protocol documents:
Clinical trial NCT01803607
Conditions: Osteoporosis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-03-14; Completion date: 2014-11-11
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess to what extent sequential treatment with odanacatib results in incremental gains in bone mineral density (BMD) over time in female participants who have received at least 3 years of bisphosphonate therapy. It was hypothesized that odanacatib treatment would increase femoral neck BMD relative to placebo after 24 months.

Detailed description:

Arms: arm 1: Participants will receive odanacatib 50 mg once weekly for 24 months. Additionally, all participants will receive weekly supplementation with 5600 international units (IU) of Vitamin D3 and, if required, will be provided with an open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. arm 2: Participants will receive dose-matched placebo to odanacatib once weekly for 24 months. Additionally, all participants will receive weekly supplementation with 5600 IU Vitamin D3 and, if required, will be provided with an open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
Interventions: intervention 1: odanacatib intervention 2: placebo to odanacatib
Intervention descriptions: intervention 1: odanacatib 50 mg oral tablet intervention 2: dose-matched placebo to odanacatib, oral tablet

Protocol documents:
Clinical trial NCT01208207
Conditions: Spondylitis, Ankylosing
Sponsor: Organon and Co
Start date: 2010-09-27; Completion date: 2014-11-12
Enrollment: 1015 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the efficacy and tolerability of two doses of etoricoxib compared to naproxen in the treatment of ankylosing spondylitis (AS). The primary objectives are to evaluate the improvement in Spinal Pain Intensity over 6 weeks of treatment with etoricoxib 90 mg or 60 mg compared to naproxen; and to evaluate the improvement in Spinal Pain Intensity over 6 weeks of treatment with etoricoxib 90 mg compared with etoricoxib 60 mg. Additionally the added benefit of increasing the dose of etoricoxib from 60 mg to 90 mg will be assessed in the second part of the study. The primary hypothesis is that the improvement in Spinal Pain Intensity visual analog scale (VAS) as measured by the time-weighted average (TWA) change from baseline over 6 weeks of treatment in Part I for etoricoxib 90 mg or 60 mg once daily is not inferior to naproxen 1000 mg.

Detailed description:

Arms: arm 1: The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib 60 mg in Part I and Part II arm 2: The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 60 mg in Part I and etoricoxib 90 mg in Part II arm 3: The etoricoxib 90 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 90 mg in Part I and Part II arm 4: The naproxen 1000 mg/naproxen 1000 mg treatment sequence will receive naproxen 1000 mg in Part I and Part II
Interventions: intervention 1: Part I - etoricoxib 60 mg intervention 2: Part I - etoricoxib 90 mg intervention 3: Part I- naproxen 1000 mg intervention 4: Part I - Placebo to naproxen 500 mg intervention 5: Part II- etoricoxib 60 mg intervention 6: Part II- etoricoxib 90 mg intervention 7: Part II- naproxen 1000 mg intervention 8: Part I - Placebo to etoricoxib 60 mg intervention 9: Part I - Placebo to etoricoxib 90 mg intervention 10: Part II- Placebo to etoricoxib 60 mg intervention 11: Part II - Placebo to etoricoxib 90 mg intervention 12: Part II- Placebo to naproxen 500 mg
Intervention descriptions: intervention 1: etoricoxib 60 mg oral tablet once daily for 6 weeks intervention 2: etoricoxib 90 mg oral tablet once daily for 6 weeks intervention 3: naproxen 500 mg oral tablet twice daily for 6 weeks intervention 4: Placebo to naproxen 500 mg oral tablet twice daily for 6 weeks intervention 5: etoricoxib 60 mg oral tablet once daily for 20 weeks intervention 6: etoricoxib 90 mg oral tablet once daily for 20 weeks intervention 7: naproxen 500 mg oral tablet twice daily for 20 weeks intervention 8: Placebo to etoricoxib 60 mg oral tablet once daily for 6 weeks. intervention 9: Placebo to etoricoxib 90 mg oral tablet once daily for 6 weeks. intervention 10: Placebo to etoricoxib 60 mg oral tablet once daily for 20 weeks. intervention 11: Placebo to etoricoxib 90 mg oral tablet once daily for 20 weeks. intervention 12: Placebo to naproxen 500 mg orally twice daily for 20 weeks.

Protocol documents: