ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00539526
Conditions: Open Angle Glaucoma Ocular Hypertension
Sponsor: Allergan
Start date: 2007-09-01; Completion date: 2008-09-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues

Detailed description:

Arms: arm 1: bimatoprost 0.03% arm 2: travoprost 0.004% arm 3: latanoprost 0.005%
Interventions: intervention 1: Bimatoprost 0.03% intervention 2: travoprost 0.004% intervention 3: latanoprost 0.005% eye drops
Intervention descriptions: intervention 1: bimatoprost 0.03%, 1 drop nightly for 3 months intervention 2: travoprost 0.004% eye drops, 1 drop nightly for 3 months intervention 3: latanoprost 0.005%, 1 drop nightly for 3 months

Protocol documents:
Clinical trial NCT00558064
Conditions: Hypertension
Sponsor: Boehringer Ingelheim
Start date: 2007-10-01; Completion date: 2008-09-01
Enrollment: 531 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
To demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to amlodipine 5 mg alone in patients with essential hypertension and inadequately controlled with amlodipine 5 mg monotherapy.

Detailed description:

Interventions: intervention 1: telmisartan+amlodipine intervention 2: amlodipine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00558428
Conditions: Hypertension
Sponsor: Boehringer Ingelheim
Start date: 2007-10-01; Completion date: 2008-09-01
Enrollment: 1098 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The primary objectives of this trial are (a) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to A10 in patients who fail to respond adequately to six weeks treatment with A5.

Detailed description:

Interventions: intervention 1: fixed dose combination of telmisartan+amlodipine intervention 2: amlodipine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00563368
Conditions: Obesity
Sponsor: VIVUS LLC
Start date: 2007-12-01; Completion date: 2008-09-01
Enrollment: 756 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety and efficacy of various doses of VI-0521 compared to both placebo, and the single-agent components that comprise each combination dose. This study will provide confirmatory data to demonstrate that doses of VI-0521 have efficacy that is greater than placebo and each of the single-agent components that comprise the combination dose.

Detailed description:

Arms: arm 1: VI-0521; high dose phentermine/topiramate arm 2: VI-0521; mid dose phentermine/topiramate arm 3: mid dose topiramate arm 4: high dose topiramate arm 5: mid dose phentermine arm 6: high dose phentermine arm 7: None
Interventions: intervention 1: VI-0521 intervention 2: VI-0521 intervention 3: topiramate intervention 4: topiramate intervention 5: phentermine intervention 6: phentermine intervention 7: VI-0521
Intervention descriptions: intervention 1: phentermine 15 mg and topiramate 92 mg, po once daily intervention 2: phentermine 7.5 mg and topiramate 46 mg, po once daily intervention 3: topiramate 46 mg, po once daily intervention 4: topiramate 92 mg, po once daily intervention 5: phentermine 7.5 mg, po once daily intervention 6: phentermine 15 mg, po once daily intervention 7: placebo, po once daily

Protocol documents:
Clinical trial NCT00564486
Conditions: Pain
Keywords: Abdominal Laparoscopic Surgery
Sponsor: Mallinckrodt
Start date: 2007-11-01; Completion date: 2008-09-01
Enrollment: 244 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research study will look at the pain relieving ability and safety of using repeated doses of intravenous (into the vein \[IV\]) acetaminophen in the treatment of moderate postoperative pain after planned or elective abdominal laparoscopic surgery, such as a laparoscopic abdominal hysterectomy or laparoscopic cholecystectomy (removal of the gall bladder).

Detailed description:
To assess the analgesic efficacy of repeated doses of intravenous acetaminophen (IV APAP) versus Placebo in the treatment of moderate postoperative pain after abdominal laparoscopic surgery.

Arms: arm 1: IV Placebo 100 ml dosed every every 6 hours for 24 hours (4 doses total). arm 2: IV Placebo 65 ml dosed every every 4 hours for 24 hours (6 doses total). arm 3: IV Acetaminophen 1 gm dosed every every 6 hours for 24 hours (4 doses total). arm 4: IV Acetaminophen 650 mg dosed every every 4 hours for 24 hours (6 doses total).
Interventions: intervention 1: IV Placebo intervention 2: IV Placebo intervention 3: IV Acetaminophen intervention 4: IV Acetaminophen
Intervention descriptions: intervention 1: IV, every 6 hours for 24 hours (4 doses total) intervention 2: IV, every 4 hours for 24 hours (6 doses total) intervention 3: IV, every 6 hours for 24 hours (4 doses total) intervention 4: IV, every 4 hours for 24 hours (6 doses total)

Protocol documents:
Clinical trial NCT00569374
Conditions: Methamphetamine Dependence
Sponsor: University of Arkansas
Start date: 2007-09-01; Completion date: 2008-09-01
Enrollment: 8 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This 7 week, open-label pilot clinical trial will examine the safety and tolerability of modafinil up to 400mg/day as a potential treatment to reduce methamphetamine use in methamphetamine-dependent volunteers.

Detailed description:

Interventions: intervention 1: Modafinil
Intervention descriptions: intervention 1: subjects attend clinic for the first week in order to receive meds; oral, 200mg/day doses for three days for initiation doses; increased to oral 400mg/day for the remainder of the trial (weeks 2-6); washout period during week 7

Protocol documents:
Clinical trial NCT00570778
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: QVA, Indacaterol, Glycopyrrolate, Concept1, COPD, cross over study, safety and efficacy, trough FEV1
Sponsor: Novartis Pharmaceuticals
Start date: 2007-12-01; Completion date: 2008-09-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD.

Detailed description:

Arms: arm 1: One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days. arm 2: Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days. arm 3: One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days. arm 4: Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Interventions: intervention 1: indacaterol/glycopyrrolate intervention 2: indacaterol intervention 3: placebo
Intervention descriptions: intervention 1: Inhalation capsule indacaterol/glycopyrrolate 300/50 μg inhaled once daily via a single dose dry powder inhaler for 7 days. intervention 2: Inhalation capsule indacaterol supplied as 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days. intervention 3: Placebo inhalation capsules inhaled once daily via a single dose dry powder inhaler for 7 days.

Protocol documents:
Clinical trial NCT00572260
Conditions: Antimicrobial Prophylaxis
Keywords: MRSA Increased risk for infection
Sponsor: Duke University
Start date: 2008-01-01; Completion date: 2008-09-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goals of the study are to evaluate the feasibility of using daptomycin as a prophylactic antimicrobial agent in patients undergoing cardiac surgery, to determine the rates of surgical site infection, and to evaluate the occurrence of adverse events.

Detailed description:

Arms: arm 1: Daptomycin as a single preoperative dose within 30 minutes prior to surgery Dosage: if creatinine clearance ≥ 30 ml/min: 6 mg/kg IV
Interventions: intervention 1: daptomycin 6 mg/kg IV
Intervention descriptions: intervention 1: daptomycin 6 mg/kg IV given during induction phase as a one-time prophylactic dose for patients undergoing cardiac valve replacement and coronary artery bypass grafting (CABG) who are at increased risk for infection due to methicillin-resistant Staphylococcus aureus (MRSA)

Protocol documents:
Clinical trial NCT00577356
Conditions: Prostate Cancer
Sponsor: Benaroya Research Institute
Start date: 2008-02-01; Completion date: 2008-09-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out what effects, good and bad, the combination of docetaxel with CG1940/CG8711 (immunotherapy drugs) have on destroying prostate cancer before removal the prostate (prostatectomy).

Detailed description:

Interventions: intervention 1: Docetaxel intervention 2: CG1940/CG8711
Intervention descriptions: intervention 1: Docetaxel 75mg/m2 will be given intravenously every 3 weeks for four cycles. intervention 2: Immunotherapy allogeneic GM-CSF secreting cellular vaccine

Protocol documents:
Clinical trial NCT00582790
Conditions: Kidney Cancer
Keywords: Renal Cell Cancer Metastatic
Sponsor: University of Wisconsin, Madison
Start date: 2003-08-01; Completion date: 2008-09-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is being done to see if we can improve the response of Interleukin-2 by adding Zoledronic acid. The effectiveness of the combination of drugs in kidney cancer is unknown and will be investigated in this study. In particular, this study will evaluate the effect of this combination on kidney cancer and will also examine the safety and side effects of IL-2 with Zoledronic acid.

Detailed description:
The purpose of this research is to evaluate the antitumor response of low-dose Interleukin-2 in combination with Zoledronic acid on subjects with previously untreated, unresectable metastatic renal cell carcinoma. Also, the study will assess the tolerability, safety, pharmacodynamic effects, and immunologic effects of low-dose Interleukin-2 in combination with Zoledronic acid on angiogenesis inhibition and anti-metastatic potential by measuring serum/plasma angiogenic/metastatic factor levels and by quantitating changes in cytokine expression, antigen-specific T-cell immune responses, and peripheral gd T-cell frequency and function.

Arms: arm 1: Interleukin-2 subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles in combination with Zoledronic acid IV on day 1 of every 4 week (28 days) cycle.
Interventions: intervention 1: IL2 intervention 2: Zoledronic acid
Intervention descriptions: intervention 1: Interleukin-2 will be given at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles. intervention 2: Zoledronic acid will be given on day 1 intravenously over 15 or 30 minutes starting at 400mcg. If no significant increase in gamma delta-T cell augmentation is seen, the dose of zoledronic acid will be increased in the subsequent cycle up to a maximum dose of 3mg.

Protocol documents:
Clinical trial NCT00590317
Conditions: Nausea and Vomiting
Sponsor: Emory University
Start date: 2005-03-01; Completion date: 2008-09-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the effect of prochlorperazine and ondansetron for the treatment of nausea and vomiting in the emergency department.

Detailed description:
Nausea and vomiting can be common symptoms in the emergency department (ED). Antiemetics, agents to treat nausea and vomiting, include phenothiazine derivatives, prokinetic agents, and 5-HT3 antagonists. There have been limited studies on the use of these agents in the ED, and no direct comparisons to 5-HT3 antagonists have been published to date.

Inclusion Criteria:

Patients presenting to the ED with at least one of the following

* nausea
* vomiting documented in the ED

Arms: arm 1: Patients receiving Prochlorperazine 10mg IV arm 2: Patient receiving Ondansetron 4mg IV
Interventions: intervention 1: Prochlorperazine intervention 2: Ondansetron
Intervention descriptions: intervention 1: Patients receiving Prochlorperazine intervention 2: Patients receiving Ondansetron

Protocol documents:
Clinical trial NCT00594425
Conditions: Acne Vulgaris
Sponsor: Photocure
Start date: 2007-02-01; Completion date: 2008-09-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multicenter study will be divided into 2 phases. The first phase will be an open label, dose-escalation phase, while the second will be a blinded, randomized, vehicle-controlled, parallel-group, dose-response phase. The second phase will only start if the first phase succeeds in establishing well tolerated dose(s). Patients with moderate to severe acne vulgaris in the face will be included.The results from part 2 has been presented in the result section.

Detailed description:
For the second part: All patients will receive 4 PDT sessions 2 weeks apart using a light dose of 37 J/cm2. One treatment group will receive vehicle cream, while the other 2 groups will receive MAL cream with a concentration of 40 mg/g and 80 mg/g, respectively. The MAL and vehicle cream will be applied in a thin layer on clean skin and left for 1.5 hours under occlusion before illumination.

Arms: arm 1: PDT using MAL concentration A arm 2: PDT using MAL concentration B arm 3: PDT using Placebo cream
Interventions: intervention 1: Methyl aminolevulinate (MAL) PDT
Intervention descriptions: intervention 1: Cream application followed by illumination with red light

Protocol documents:
Clinical trial NCT00594854
Conditions: Gastric Ulcer
Keywords: NSAID Gastric Ulcer High risk Arthrotec Vimovo
Sponsor: POZEN
Start date: 2007-09-01; Completion date: 2008-09-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, double-blind, parallel-group, controlled, multi-center clinical trial of 6 months duration is designed to assess the efficacy, tolerability and safety of PN400 versus diclofenac/misoprostol in subjects at high risk for developing NSAID-associated gastric ulcers. Approximately 100 sites will participate to enroll a total of 200 subjects (100 per arm).

At least 20% of the subjects enrolled will be age 65 years and older.

Detailed description:
To determine the incidence of gastric ulcers following administration of PN 400 in a high risk population over six months. Diclofenac/misoprostol will be used as a positive control.

Secondary:

* To determine the incidence of duodenal ulcers during treatment with PN 400 and diclofenac/misoprostol in a high risk population
* To evaluate the degree of upper gastrointestinal injury as measured by Lanza scores (1991) during treatment with PN400 and diclofenac/misoprostol in a high risk population
* To compare gastrointestinal symptoms in subjects treated with PN 400 versus diclofenac/misoprostol as measured by scores on the Gastrointestinal Symptoms Rating Scale (GSRS) instrument
* To evaluate the safety and tolerability of PN400 and diclofenac/misoprostol in a high risk population

Arms: arm 1: PN 400 (esomeprazole/naproxen) dosed twice daily arm 2: diclofenac 75mg/misoprostol 200 mcg dosed twice daily
Interventions: intervention 1: PN400 (VIMOVO) intervention 2: Diclofenac/Misoprostol
Intervention descriptions: intervention 1: PN400 tablet (500 mg delayed-release naproxen/20 mg immediate-release esomeprazole) given by mouth twice daily (bid). intervention 2: Over-encapsulated ARTHROTEC® 75 (75 mg diclofenac sodium/200 mcg misoprostol) capsules given by mouth bid.

Protocol documents:
Clinical trial NCT00597909
Conditions: Hepatic Encephalopathy
Keywords: Ammonul® sodium phenylacetate and sodium benzoate hepatic encephalopathy Grade 3 or 4 Hepatic Encephalopathy
Sponsor: Amgen
Start date: 2007-12-01; Completion date: 2008-09-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the safety and effectiveness of Ammonul® in subjects who become hospitalized with Grade 3 or 4 hepatic encephalopathy (HE).

Detailed description:
Hepatic encephalopathy (HE) is a reversible neuropsychiatric syndrome seen in patients with liver disease. The pathogenesis of HE is incompletely understood, but several pieces of evidence identify ammonia as a key factor in the development of HE. The liver normally detoxifies ammonia produced in the gastrointestinal tract. However, in patients with cirrhosis, portosystemic shunting allows ammonia to bypass the liver and reach the systemic circulation and the brain. The accumulation of ammonia in the brain, through mechanisms not yet fully defined, lead to changes of consciousness, intellectual function, and behavior.

Ammonul is currently approved as adjuvant therapy for the management of hyperammonemia and associated encephalopathy in patients with deficiencies in the enzymes of the urea cycle. Ammonul removes nitrogenous ammonia in these patients through pathways alternative to the urea cycle. It is anticipated that in patients with HE, Ammonul may lead to the scavenging of ammonia through these alternative biochemical pathways taking place in tissues other than the liver.

This study is designed to test the efficacy and safety of IV Ammonul® as a treatment for acute episodes of elevated ammonia in patients with Grade 3 or 4 HE. Study was terminated due to lack of enrollment and business decisions.

Study with completed results acquired from Horizon in 2024

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: sodium phenylacetate and sodium benzoate injection 10% / 10% intervention 2: sodium phenylacetate and sodium benzoate injection 10% / 10% intervention 3: placebo solution (10% dextrose)
Intervention descriptions: intervention 1: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours) intervention 2: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours) intervention 3: Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)

Protocol documents:
Clinical trial NCT00600171
Conditions: Asthma
Keywords: dose ranging placebo asthma safety efficacy pharmacokinetics
Sponsor: GlaxoSmithKline
Start date: 2007-12-01; Completion date: 2008-09-01
Enrollment: 614 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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

Detailed description:

Arms: arm 1: Placebo Multi dose dry powder inhlaer arm 2: GW642444M
Interventions: intervention 1: GW642444M intervention 2: Placebo
Intervention descriptions: intervention 1: GW642444M intervention 2: Placebo mulit-dose dry powder inhaler

Protocol documents:
Clinical trial NCT00603512
Conditions: Arthritis, Rheumatoid
Keywords: Phase II MTX add-on study in Japan
Sponsor: Pfizer
Start date: 2008-01-01; Completion date: 2008-09-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effectiveness and safety, over 3 months, of 4 dose regimens of CP-690,550, combined with methotrexate, for the treatment with active rheumatoid arthritis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Placebo intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: CP-690,550 intervention 5: CP-690,550
Intervention descriptions: intervention 1: 0 mg BID, 3 blinded tablets administered BID for 12 weeks intervention 2: 10 mg BID, 3 blinded tablets administered BID for 12 weeks intervention 3: 1 mg BID, 3 blinded tablets administered BID for 12 weeks intervention 4: 3 mg BID, 3 blinded tablets administered BID for 12 weeks intervention 5: 5 mg BID, 3 blinded tablets administered BID for 12 weeks

Protocol documents:
Clinical trial NCT00619970
Conditions: Chronic Abdominal Pain Small Intestinal Bacterial Overgrowth
Sponsor: Children's Hospital Los Angeles
Start date: 2007-02-01; Completion date: 2008-09-01
Enrollment: 115 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Chronic abdominal pain (CAP) is an extremely pervasive childhood condition and, like IBS in adults, it is one of the functional bowel disorders without a clear framework of understanding or an effective treatment. However, new research suggests that small intestinal bacterial overgrowth (SIBO) may be the unifying pathophysiology that explains the variety of symptoms experienced by patients with IBS. As CAP in children is believed to be a precursor to IBS in adults, we hypothesize that children with this disorder have a significantly greater prevalence of small intestinal bacterial overgrowth (SIBO) than normal, healthy children, and that eradication of bacterial overgrowth with antibiotics will reduce symptoms of chronic abdominal pain in children with this condition. To prove this, we will first aim to determine the prevalence of SIBO in both healthy children and those with CAP. We will do this by performing a lactulose breath hydrogen test, the gold standard for the noninvasive measurement of SIBO, on 40 healthy controls and 80 subjects with CAP. We will then assess whether eradication of SIBO with antibiotics will reduce symptoms of chronic abdominal pain in children with this condition. To do this we will randomize, in a double-blinded fashion, the 80 CAP patients to receive a 10-day course of either the antibiotic Rifaximin or a placebo. After completion of the treatment we will evaluate all these patients for eradication of bacterial overgrowth by repeating a lactulose breath hydrogen test. We will also assess for symptom improvement by re-administering questionnaires.

Detailed description:

Arms: arm 1: Healthy controls arm 2: 2/3 Patients with CAP arm 3: 1/3 patients with CAP
Interventions: intervention 1: Lactulose Breath Test intervention 2: xifaxan intervention 3: placebo intervention 4: Lactulose Breath Test
Intervention descriptions: intervention 1: Healthy controls will receive one lactulose breath test to assess for SIBO intervention 2: xifaxan 550mg TID x10days intervention 3: placebo TID x 10days intervention 4: Children with CAP will receive one lactulose breath test to assess for SIBO and one after receiving either Rifaximin or Placebo

Protocol documents: