ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00719160
Conditions: Osteoporosis
Keywords: Gastric acid Dietary protein Calcium Intestinal absorption Calcium sensing receptor
Sponsor: Yale University
Start date: 2005-01-01; Completion date: 2008-05-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
We have established that dietary protein is an important regulator of intestinal calcium absorption in humans. However, we do not understand the mechanism by which dietary protein is affecting calcium absorption. Therefore, the purpose of this research is to evaluate whether dietary protein-induced changes in gastric acid secretion explain the observed changes in intestinal calcium absorption.

Detailed description:
We have established that dietary protein is an important regulator of intestinal calcium absorption in humans. However, we do not understand the mechanism by which dietary protein is affecting calcium absorption. Therefore, the purpose of this research is to evaluate whether dietary protein-induced changes in gastric acid secretion explain the observed changes in intestinal calcium absorption. We have compelling in vitro data that amino acids can stimulate gastric acid secretion. We have found that this occurs via allosteric activation of the calcium sensing receptor expressed on the gastric acid-secreting parietal cells. At a fixed concentration of extracellular calcium, addition of L but not D isomers of specific amino acids activates the calcium sensing receptor and stimulates parietal cell acid production. We hypothesize that dietary protein induced gastric acid production increases calcium solubility and bioavailability thereby increasing its absorption. We will test this hypothesis in humans by quantifying the impact of dietary protein on intestinal calcium absorption in subjects who cannot make gastric acid. We will measure intestinal calcium absorption in healthy adults as they consume either a high protein diet with concomitant administration of a proton pump inhibiting (PPI) drug or the same high protein diet with a placebo instead of a PPI. The order of the 2 interventions will be randomized, and study will be double-blind and placebo controlled. If our hypothesis is correct, then intestinal calcium absorption will be highest during the high protein diet with placebo, and lowest during the drug intervention.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: esomeprazole intervention 2: Placebo
Intervention descriptions: intervention 1: 2 Interventions with esomeprazole 20 mg twice a day for 9 days vs. a placebo for 9 days while on a high protein diet intervention 2: Placebo 20 mg twice a day for 9 days

Protocol documents:
Clinical trial NCT00762645
Conditions: Angle-closure Glaucoma
Keywords: IOP lowering efficacy CACG
Sponsor: Alcon Research
Start date: 2007-02-01; Completion date: 2008-05-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate that the Intraocular Pressure (IOP) lowering efficacy of Travoprost Ophthalmic Solution 0.004% is superior to that of Pilocarpine 1% in patients with chronic angle-closure glaucoma (CACG).

Detailed description:

Arms: arm 1: One drop in each eye, once daily at 9 AM arm 2: One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks
Interventions: intervention 1: Travoprost 0.004% (Travatan) intervention 2: Pilocarpine 1%
Intervention descriptions: intervention 1: One drop in each eye, once daily at 9 AM intervention 2: One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks

Protocol documents:
Clinical trial NCT00768560
Conditions: Hypertension
Sponsor: Bayer
Start date: 2008-01-01; Completion date: 2008-05-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a multi-center, randomized, double-blind, 6 x 3 cross-over study. All patients who meet the entry criteria will be required to stop taking any other anti-hypertensive agents than Adalat CR (controlled release), if taken, before starting 4 weeks (±7days) open-label Adalat CR 40 mg once daily (OD) treatment phase (baseline treatment period). Of them, those who are confirmed with their eligibility as subjects for the present study at the end of the baseline treatment period will be randomly allocated to one of the 6 treatment sequences on the basis of a computer-generated randomization list. Subsequently, BAY A1040 CR tablet 40 mg OD, 40 mg twice daily (BID) or 80 mg OD will be administered to a total of 6 weeks, 2 weeks per each treatment period (Period 1-3) under double-blind conditions using BAY A1040 CR tablet 40 mg and its placebo as follows (Double-blind treatment period).

Detailed description:
Issues on safety are addressed in the Adverse Event section.

Arms: arm 1: Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning arm 2: Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening arm 3: Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
Interventions: intervention 1: Nifedipine (Adalat CR, BAYA1040) 80mg OD intervention 2: Nifedipine (Adalat CR, BAYA1040) 40mg BID intervention 3: Nifedipine (Adalat CR, BAYA1040) 40mg OD
Intervention descriptions: intervention 1: Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning intervention 2: Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening intervention 3: Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning

Protocol documents:
Clinical trial NCT00821587
Conditions: Hepatitis C
Keywords: Hepatitis C Post Liver Transplant
Sponsor: University of Florida
Start date: 2004-06-01; Completion date: 2008-05-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of cyclosporine, an anti-rejection drug, on the clearance of the hepatitis C virus in liver transplant subjects being treated with peg-interferon and ribavirin.

Detailed description:
This is a randomized, single-center controlled study comparing two different immunosuppression regimens (CsA and TAC) in patients with recurrent HCV after LT undergoing antiviral therapy for HCV.

Arms: arm 1: Tacrolimus arm 2: Cyclosporine
Interventions: intervention 1: Cyclosporine intervention 2: Tacrolimus
Intervention descriptions: intervention 1: Patients randomized to CsA had TAC discontinued and were treated with CsA at a dose of 2.0-4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150-200 ng/ml. intervention 2: Patients receiving TAC were treated with a dose of 0.08-0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10-15 ng/ml for the first month post-transplant followed by 5-10 ng/ml thereafter. Immunosuppression was typically tapered to monotherapy (TAC alone) within 4-6 months of transplantation.

Protocol documents:
Clinical trial NCT00929201
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-01-01; Completion date: 2008-05-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will demonstrate the bioequivalence of metformin after single dose administration of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet and concomitant administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual tablets after consumption of a high-fat meal.

Detailed description:

Arms: arm 1: Participants receive sitagliptin (Sita) 50 mg and metformin (Met) 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg FDC tablet administered as a single dose during Period 2. arm 2: Participants receive sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.
Interventions: intervention 1: Sitagliptin phosphate/metformin hydrochloride FDC intervention 2: Sitagliptin phosphate intervention 3: Metformin hydrochloride
Intervention descriptions: intervention 1: Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods. intervention 2: Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods. intervention 3: Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods.

Protocol documents:
Clinical trial NCT01198275
Conditions: Atrial Fibrillation
Keywords: PUFA atrial fibrillation
Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Start date: 2006-01-01; Completion date: 2008-05-01
Enrollment: 199 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effect of n-3 PUFAs in addition to amiodarone and renin-angiotensin-aldosterone system (RAAS) inhibitors on the maintenance of sinus rhythm after electrical conversion in patients with persistent Atrial fibrillation (AF).

Detailed description:
Atrial fibrillation (AF) is the most common sustained arrhythmia and represents an increasing burden on the healthcare system. Treatment of AF remains controversial. In patients on antiarrhythmic therapy, the one-year relapse rates of AF after cardioversion ranges from 44% to 77% at one year and amiodarone appears to the be the most effective in maintaining sinus rhythm.Over the last few years, a growing amount of evidences has supported the protective effects of n-3 PUFAs in preventing ventricular arrhythmias and reducing the risk of sudden cardiac death. Furthermore, in the last years, the interest for their possible beneficial role in AF prevention has been increasing.We hypothesized that the administration of n-3 PUFAs could reduce the AF recurrence rate more than amiodarone plus RAAS inhibitors in patients with persistent AF. Therefore the present study aims to evaluate the role of n-3 PUFAs in the prophylaxis of AF recurrences after DCCV in addition to amiodarone and RAS blockers therapy in patients with persistent AF.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: n-3 PUFAs intervention 2: Placebo intervention 3: RASS inhibitors and/or RAS blockers intervention 4: Amiodarone
Intervention descriptions: intervention 1: 1.0 g of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in the average ratio EPA/DHA of 0.19:1.5, one capsule twice a day intervention 2: 1.0 g of olive oil,one capsule twice a day intervention 3: Patients on ACE-Is or ARBs were continued on the same agent. In those who were not on therapy, an ACE-I or an ARB was started. In all patients, an effort was made to achieve the highest tolerated dose. intervention 4: Patients on amiodarone were continued at a maintenance dose of 200 mg daily, whereas those who were not taking amiodarone were started at a dose of 400 mg daily for 1 week and then continued on a maintenance dose of 200 mg daily.

Protocol documents:
Clinical trial NCT01321710
Conditions: Pregnancy Postpartum Period Sleep Disturbance
Keywords: sleep hygiene actigraphy maternal infant postpartum period immunization acetaminophen
Sponsor: University of California, San Francisco
Start date: 2004-12-01; Completion date: 2008-05-01
Enrollment: 152 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test a behavioral intervention to minimize sleep disruption and fatigue in new mothers after the birth of their first infant. This study also tests whether an acetaminophen intervention at the time of an infant's 2-month immunization series improves infant and maternal sleep.

Detailed description:

Arms: arm 1: Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.

Infants in this arm receive no intervention beyond standard immunization care. arm 2: Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.

Infants in this arm receive standard immunization care. arm 3: Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.

Infants in this arm receive an acetaminophen intervention (12.5mg per kg infant weight, 1 dose 30 minutes prior to immunization and q4-6h thereafter, for a total of 5 doses) to minimize sleep disturbance following immunization.
Interventions: intervention 1: Sleep hygiene intervention 2: Dietary information intervention 3: Acetaminophen
Intervention descriptions: intervention 1: This intervention consists of behavioral strategies for minimizing maternal arousal and sleep disturbance as a result of night-time infant care. Key components include: infant proximity, low lighting, and noise attenuation.

It is administered to women during their last month of pregnancy. intervention 2: This intervention consists of dietary information aimed at improving postpartum sleep. The recommendations include avoiding alcohol, caffeine, and heavy meals before bed, as well as eating healthy foods. intervention 3: 51-90mg depending on infant weight (12.5mg per kg infant weight). Administered 30 minutes prior to immunization and q4-6h for a total of 5 doses.

Protocol documents:
Clinical trial NCT01353144
Conditions: Peptic Ulcer
Keywords: aspirin peptic ulcer
Sponsor: Kaohsiung Veterans General Hospital.
Start date: 2007-06-01; Completion date: 2008-05-01
Enrollment: 178 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.

Detailed description:
The aims of this study are to compare esomeprazole plus aspirin with esomeprazole alone in the treatment of aspirin-related ulcers.

Patients with aspirin-related peptic ulcers are randomized to receive esomeprazole (40 mg/day) plus aspirin (100 mg/day) or esomeprazole (40 mg/day) alone for 8 weeks. Follow-up endoscopy was carried out at the end of the eighth week. The primary end point was the healing of peptic ulcers.

Arms: arm 1: esomeprazole (40 mg/day) for 8 weeks arm 2: esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks
Interventions: intervention 1: aspirin
Intervention descriptions: intervention 1: aspirin, 100 mg, qd x 8 weeks

Protocol documents:
Clinical trial NCT01363076
Conditions: Postoperative Pain
Sponsor: Egalet Ltd
Start date: 2007-06-01; Completion date: 2008-05-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This was an open-label PK study in pediatric subjects who had undergone general surgery. Each subject's study participation consisted of a screening visit, a single-dose treatment with intranasal ketorolac (IN) tromethamine, and a follow-up visit.

Following surgery, subjects received IN ketorolac 15 mg (weight \< 50 kg) or 30 mg (weight \> or = 50 kg) when pain relief was indicated. For pain not relieved by the study drug, the subjects had access to an opioid analgesic administered by patient-controlled analgesia (PCA). Blood samples for pharmacokinetic analysis were obtained at specified time points following the dose of ketorolac.

Detailed description:

Arms: arm 1: Ketorolac Tromethamine - single dose (15 mg) administered intranasally (IN) for subjects weighing \<50 kg. arm 2: Ketorolac Tromethamine - single dose (30 mg) administered intranasally (IN) for subjects weighing ≥50 kg.
Interventions: intervention 1: Ketorolac Tromethamine intervention 2: Ketorolac Tromethamine
Intervention descriptions: intervention 1: Single IN dose of 15 mg ketorolac tromethamine for subjects weighing \<50 kg. intervention 2: Single IN dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.

Protocol documents:
Clinical trial NCT01728246
Conditions: Osteoarthritis
Keywords: Osteoarthritis Celecoxib Tramadol Paracetamol
Sponsor: Janssen Pharmaceutica
Start date: 2007-10-01; Completion date: 2008-05-01
Enrollment: 473 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and effects on Quality of Life (QOL) of tramadol/paracetamol (APAP) as an add-on therapy (medication taken in addition to another medication) in Filipino participants with chronic (lasting a long time) osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff).

Detailed description:
This is an open-label (all people know the identity of the intervention), randomized (study drug assigned by chance), controlled study to evaluate the efficacy, safety and effects on QOL of tramadol/APAP as an add-on therapy in Filipino participants suffering from chronic pain because of chronic osteoarthritis. Participants will be randomly assigned to 2 groups: tramadol/APAP group and non tramadol/APAP group. Participants in tramadol/APAP group will receive celecoxib 200 milligram (mg) and fixed dose combination of tramadol (37.5 mg)/APAP (325 mg) as add on therapy, while the participants in non-tramadol/APAP group will receive celecoxib 200 mg only. The total duration of the study will be 4 weeks. The participants in both the groups will be given celecoxib 200 mg once daily for 4 weeks. In addition, the participants in the tramadol/APAP group will be given add-on tramadol/APAP doses 3 times a day for 4 weeks. Participants will be asked to return for follow-up at Weeks 2 and 4. Efficacy will be assessed using 100 millimeter (mm) Visual Analog Scale (VAS) while QOL will be assessed using the Oswestry Disability Index (ODI). Participant safety will be monitored throughout the study.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tramadol/Paracetamol (APAP) intervention 2: Non-Tramadol/APAP
Intervention descriptions: intervention 1: Celecoxib 200 milligram (mg) once daily for 4 weeks and fixed dose combination of Tramadol 37.5 mg/Paracetamol 325 mg thrice daily for 4 weeks as add-on therapy. intervention 2: Celecoxib 200 mg alone once daily for 4 weeks.

Protocol documents:
Clinical trial NCT01843660
Conditions: Low Back Pain Shoulder Pain Neck Pain
Keywords: Low back pain Shoulder pain Neck pain Tramadol hydrochloride Paracetamol
Sponsor: Xian-Janssen Pharmaceutical Ltd.
Start date: 2007-09-01; Completion date: 2008-05-01
Enrollment: 1059 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride-paracetamol tablets in treatment of moderate (medium level of seriousness) to severe (very serious) acute neck, shoulder and low back pain in orthopedics (pertaining to the bones) outpatient or emergency setting.

Detailed description:
This is an open-label (all people know the identity of the intervention), non-randomized, multi-center (when more than one hospital or medical school team work on a medical research study) and prospective (study following participants forward in time) study of tramadol hydrochloride-paracetamol tablets. Participants will receive 1 to 2 tablets of tramadol hydrochloride-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \[mg\] and paracetamol 325mg). Participants may be given the additional dose according to the clinical requirement. The total treatment duration will be 6 hours. The total study duration will be 4 months. Efficacy will be evaluated primarily by pain intensity and pain relief. Participants will evaluate the pain severity and pain relief at 0.5, 1, 2, 3, 4 and 6 hours respectively after the first dose; and the drug efficacy and overall satisfaction level at the end of 6 hours after the first dose. Participants' safety will be monitored throughout the study.

Arms: arm 1: None
Interventions: intervention 1: Tramadol HCl-Paracetamol
Intervention descriptions: intervention 1: Participants will receive 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \[mg\] and paracetamol 325mg) for up to a total duration of 6 hours. Additional dose may be given based upon the clinical requirement.

Protocol documents:
Clinical trial NCT02079519
Conditions: Multiple Myeloma
Sponsor: Hoffmann-La Roche
Start date: 2006-05-01; Completion date: 2008-05-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluated the efficacy and safety of Avastin (bevacizumab, 5 mg/kg intravenously every 2 weeks) in patients with multiple myeloma, relapsed/refractory after at least 2 lines of prior therapy.

Detailed description:

Arms: arm 1: Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
Interventions: intervention 1: Bevacizumab
Intervention descriptions: intervention 1: Bevacizumab was provided as a concentrate in vials.

Protocol documents:
Clinical trial NCT02159482
Conditions: Cancer
Sponsor: Duke University
Start date: 2005-11-01; Completion date: 2008-05-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study is for people who have previously received cancer vaccines. The investigators are testing a form of therapy known as interferon alfa-2a, which is commercially available as the drug Roferon®-A, to see if it can be used to help boost the effects of the cancer vaccine and help the immune system attack the cancer.

It is believed that the body's immune system can attack tumor cells and kill them. This is thought to be due to immune cells called T cells which can recognize special proteins on the surface of tumors as a signal to fight the cancer. However, the vaccine may not work very well if the protein signal is too weak for the T cells to find your tumors. The investigators think that interferon alfa-2a can signal the cancer cells in the body to make more proteins that may allow the T cells to recognize and kill the cancer cells better.

Detailed description:

Arms: arm 1: Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.
Interventions: intervention 1: Interferon Alfa-2a
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02761629
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2005-04-01; Completion date: 2008-05-01
Enrollment: 180 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, multi-center, Phase IV, comparative study will assess the efficacy and safety of combined peg-interferon alpha-2a (Peg-IFN-Alpha-2A) and ribavirin therapy for 48 or 72 weeks of treatment and 24 weeks of follow-up in participants with Genotype 1 chronic hepatitis C (CHC), co-infected with human immunodeficiency virus type 1 (HIV-1).

Detailed description:

Arms: arm 1: Participants will receive Peg-IFN-Alpha-2A and ribavirin for 48 weeks. arm 2: Participants will receive Peg-IFN-Alpha-2A and ribavirin for 72 weeks.
Interventions: intervention 1: Peg-Interferon Alpha-2A intervention 2: Ribavirin
Intervention descriptions: intervention 1: Peg-IFN-Alpha-2A will be administered at 180 micrograms (mcg) once weekly via subcutaneous injection. intervention 2: Ribavirin will be administered as either 1000 milligrams (mg) (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing less than (\<) 75 kilograms (kg) or as 1200 mg (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing greater than or equal to (\>/=) 75 kg.

Protocol documents: