ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01842581
Conditions: Hepatic Encephalopathy Cirrhosis
Keywords: Liver Failure Hepatic Insufficiency Liver Diseases Brain Diseases Rifaximin Cirrhosis
Sponsor: Bausch Health Americas, Inc.
Start date: 2013-01-08; Completion date: 2014-12-17
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate if rifaximin alone or rifaximin plus lactulose delays the onset of hepatic encephalopathy (HE) in participants with cirrhosis who have had a previous episode of HE.

Detailed description:

Arms: arm 1: Participants will receive rifaximin 550 milligrams (mg) tablet orally twice daily (BID) for 24 weeks. arm 2: Participants will receive rifaximin 550 mg tablet orally BID with lactulose solution for 24 weeks. Lactulose dose will be self-titrated by the participant to produce 2 to 3 soft stools per day.
Interventions: intervention 1: Rifaximin intervention 2: Lactulose
Intervention descriptions: intervention 1: Rifaximin will be administered per the dose and schedule specified in the arms. intervention 2: Laculose will be administered per the schedule specified in the respective arm.

Protocol documents:
Clinical trial NCT01558674
Conditions: Renal Impairment Heart Failure
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-05-23; Completion date: 2014-12-17
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Part I is a 3-period, active comparator-controlled, fixed sequence study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-7145 compared to furosemide in participants with moderate-to-severe renal insufficiency (RI) without heart failure (HF). Primary hypothesis for Part I is that at least one well-tolerated dose of MK-7145 will produce a greater 24hr urinary excretion of sodium (UNa) on the 1st day of MK-7145 dosing than 80 mg furosemide (on the 1st day of furosemide dosing) in participants with moderate-to-severe RI. If MK-7145 is safe at natriuretic doses in RI in Part I of this study, MK-7145 will be investigated in participants with heart failure (HF) and RI (Part II).

Part II is 4 period, fixed sequence, active comparator controlled (in Period 1), titration (in Periods 2, 3 and 4) study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a titration regimen of MK-7145 compared to an optimized stable maintenance regimen of furosemide or torsemide in participants with New York Heart Association (NYHA) Class II and III heart failure and moderate or severe renal insufficiency. The primary hypothesis for Part II is that at least one dose of MK-7145, titrated according to a fixed dose titration regimen, will be associated with a reduction in N-terminal pro-brain natriuretic peptide (NT-proBNP) compared to furosemide or torsemide (at 24 hours post morning dose on the last dosing day of each period) in participants with NYHA class II/III HF with moderate or severe RI.

Detailed description:

Arms: arm 1: Single daily dose of 8 mg MK-7145 for 5 days, capsules, orally administered in a fasted state arm 2: Two daily doses of one 40 mg Furosemide tablet for 5 days administered in a fasted state arm 3: Single daily dose of 16 mg MK-7145 for 5 days, capsules, orally administered in a fasted state arm 4: Run-in of stable, clinically optimized maintenance dose regimen of furosemide or torsemide for at least 2 weeks arm 5: Single daily dose of 10 mg MK-7145 for 14 days, capsules, orally administered in a fasted state arm 6: Single daily dose of 16 mg MK-7145 for 14 days, capsules, orally administered in a fasted state arm 7: Single dose of 24 mg MK-7145 for 28 days, capsules, orally administered in a fasted state
Interventions: intervention 1: MK-7145 intervention 2: Furosemide intervention 3: Torsemide
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01778023
Conditions: Growth Disorder Idiopathic Short Stature
Sponsor: Novo Nordisk A/S
Start date: 2013-01-17; Completion date: 2014-12-17
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of recombinant human growth hormone (hGH) in subjects with idiopathic short stature in Korea.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: somatropin
Intervention descriptions: intervention 1: A weekly dosage of 0.469 mg of somatropin per kg of body weight per week will be injected subcutaneously (under the skin) in the evening in 7 days per week.

Protocol documents:
Clinical trial NCT00915967
Conditions: Surgical Wound Infections
Keywords: Infection Vancomycin Neurosurgery Stimulator Pump Deep Brain Stimulation Intrathecal Pump
Sponsor: Oregon Health and Science University
Start date: 2009-05-13; Completion date: 2014-12-19
Enrollment: 214 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this study is to determine whether injecting the antibiotic vancomycin directly into surgical wounds can decrease the rate of infection following implantation of neurosurgical devices.

Detailed description:

Arms: arm 1: Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket. arm 2: Subjects in the saline group will receive a Saline injection directly into the wound pocket.
Interventions: intervention 1: Vancomycin intervention 2: Placebo (Saline Solution)
Intervention descriptions: intervention 1: Subjects randomized to the vancomycin group will receive an injection (up to 10 mL) of 5 mg/mL vancomycin administered directly into the wound with a blunt needle following watertight fascial closure. intervention 2: Subjects randomized to the saline group will receive an injection (up to 10 mL) of saline solution directly into the wound following watertight fascial closure.

Protocol documents:
Clinical trial NCT02281344
Conditions: Malaria, Falciparum
Keywords: induced blood stage malaria infection
Sponsor: Medicines for Malaria Venture
Start date: 2014-10-01; Completion date: 2014-12-19
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A single-centre, open-label, study using induced blood stage malaria infection to characterize the activity of MMV390048 against early Plasmodium falciparum blood stage infection.

Detailed description:
Study using induced blood stage malaria infection to characterize the activity of MMV390048 against early Plasmodium falciparum blood stage infection. There will be two or more cohorts of 8 subjects. In the first cohort a single dose of 20 mg of MMV390048 will be investigated. Depending on the data obtained, the dose in Cohort 2 may be adjusted but will not exceed the maximum tolerated dose (or highest achieved dose based on a predefined exposure cap) as determined in an ongoing single ascending dose study. Each participant will be inoculated on Day 0 with \~1,800 viable parasites of Plasmodium falciparum-infected human erythrocytes intravenously. On an outpatient basis, participants will be monitored daily until positive for presence of malaria parasites. Once positive they will be monitored twice-daily until treatment, for adverse events and the unexpected early onset of symptoms, signs or parasitological evidence of malaria. On the day designated for commencement of treatment, participants will be admitted to the study unit and monitored. The threshold for commencement of treatment will be when quantification of all participants is ≥ 1,000 parasites/mL. If the quantification of any participant is ≥ 5,000 parasites/mL, and is accompanied by a clinical symptom score \>5, or if clinical or parasitological evidence of malaria occurs in any participant before all participants have reached the treatment threshold (quantification of ≥ 1,000), then treatment of that participant will begin within a 24 h period.

Following treatment with MMV390048, participants will be followed up as inpatients for at least 72 hours to ensure tolerance of the treatment and clinical response, then on an outpatient basis if clinically well for monitoring of safety and clearance of malaria parasites. Compulsory treatment with Riamet® (artemether-lumefantrine) will start on day 16 (±3 days) post study treatment unless required earlier. Early intervention can occur if either poor responses or fast responses are seen following MMV390048 treatment. This is to ensure participant safety and to avoid participant inconvenience if useful data cannot be obtained. Pre-emptive treatment with Riamet® can commence whenever necessary. Participants will be treated with a single dose (45 mg) of primaquine (Primacin™) at the end of their Riamet® treatment if gametocytes are identified, to ensure complete clearance of any gametocytes present.

Arms: arm 1: Cohort 1 will receive a single dose of 20mg MMV390048.
Interventions: intervention 1: MMV390048 20mg
Intervention descriptions: intervention 1: Supplied as a powder to be prepared as a suspension for oral use

Protocol documents:
Clinical trial NCT02161146
Conditions: Conjunctivitis, Allergic
Sponsor: Allergan
Start date: 2014-06-04; Completion date: 2014-12-20
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of AGN-229666 for the prevention of allergen-mediated conjunctivitis.

Detailed description:

Arms: arm 1: One drop of AGN-229666 in each eye on Days 1 and 15. arm 2: One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15. arm 3: One drop of olopatadine in each eye on Days 1 and 15. arm 4: One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15. arm 5: One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
Interventions: intervention 1: AGN-229666 intervention 2: Vehicle to AGN-229666 intervention 3: Olopatadine
Intervention descriptions: intervention 1: One drop of AGN-229666 in the eye on Days 1 and 15. intervention 2: One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15. intervention 3: One drop of olopatadine in the eye on Days 1 and 15.

Protocol documents:
Clinical trial NCT01288937
Conditions: Idiopathic Peripheral Neuropathy
Keywords: Milnacipran Idiopathic Peripheral Neuropathy Diabetic neuropathy Neuropathic pain
Sponsor: Columbia University
Start date: 2011-04-05; Completion date: 2014-12-23
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an 11-week randomized, double-blind, placebo-controlled trial of Milnacipran 100 mg/d in patients with idiopathic neuropathic pain. Milnacipran, a dual norepinephrine and serotonin reuptake inhibitor has been a safe and beneficial treatment for patients with fibromyalgia and may be useful to treat patients with painful peripheral neuropathy.

The primary outcome will be assessed by the change in daily averaged weekly 0-10 pain intensity score, from baseline to week 9, by intention to treat analysis. The same analysis will be used on several secondary measures including daily averaged weekly 0-10 pain intensity score the sleep interference scale and the Rand-36 quality of life scale.

Detailed description:
Milnacipran helps serotonin and noradrenaline work more effectively on the central nervous system. Serotonin and noradrenaline are molecules made by the brain that affect how your body responds to pain. Milnacipran, a dual norepinephrine and serotonin reuptake inhibitor has been a safe and beneficial treatment for patients with fibromyalgia and may be useful to treat patients with painful peripheral neuropathy. Many clinical trials for neuropathy pain are done in patients with diabetic neuropathy. Idiopathic neuropathy however, is a common cause of neuropathy and accounts for 25% of all neuropathies, and over 50% of small fiber neuropathies. The information in this study will provide information on whether milnacipran also provide benefit as a medication for neuropathic pain.

Arms: arm 1: Patients will receive Milnacipran arm 2: Patients will receive Placebo
Interventions: intervention 1: Milnacipran intervention 2: Placebo
Intervention descriptions: intervention 1: Patients will be randomly assigned to receive milnacipran 100 mg/day (including a 1 week dose titration period):

Day 1: 12.5 mg once Day 2, 3: 25 mg/day (12.5 mg twice daily) Day 4, 7: 50 mg/day (25 mg twice daily) After Day 7: 100 mg/day (50 mg twice daily) intervention 2: Patients will be randomly assigned to placebo for 9 weeks (including a 1 week dose titration period), matching the schedule of the study drug.

Protocol documents:
Clinical trial NCT01704261
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-10-18; Completion date: 2014-12-23
Enrollment: 307 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the safety and efficacy of the addition of omarigliptin in participants with type 2 diabetes mellitus with inadequate glycemic control on metformin and glimepiride. The primary hypothesis is that after 24 weeks, the addition of treatment with omarigliptin provides a greater reduction in hemoglobin A1c (A1C) compared with the addition of placebo.

Detailed description:

Arms: arm 1: Omarigliptin (MK-3102) 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \>=1500 mg per day). arm 2: Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose \>=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose \>=1500 mg per day).
Interventions: intervention 1: Omarigliptin intervention 2: Matching placebo to Omarigliptin intervention 3: Glimepiride intervention 4: Metformin
Intervention descriptions: intervention 1: Omarigliptin 25 mg capsule administered orally once a week intervention 2: Matching placebo to omarigliptin capsule administered orally once a week intervention 3: Open-label glimepiride tablet(s) administered orally once daily for a total daily dose \>=4 mg. In the event of hypoglycemia, the glimepiride dose may be down-titrated to a minimum dose of 1 mg daily. intervention 4: Open-label metformin tablet(s) administered orally once or twice daily for a total daily dose \>=1500 mg

Protocol documents:
Clinical trial NCT02040779
Conditions: Persistent Asthma
Keywords: asthma breath-actuated inhaler beclomethasone
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2013-12-26; Completion date: 2014-12-24
Enrollment: 273 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled parallel-group study. Participants will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage of 80 or 160 mcg/day delivered via a Breath-Actuated Inhaler (BAI); or a matching BAI placebo, in a 1:1:1 ratio after a 14- to 21-day run-in period. Participants and investigators will remain blinded to randomized treatment assignment during the study

Detailed description:

Arms: arm 1: 40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day. arm 2: 80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day. arm 3: Placebo breath-actuated inhaler (BAI) twice daily.
Interventions: intervention 1: Beclomethasone dipropionate breath-actuated inhaler intervention 2: Placebo breath-actuated inhaler intervention 3: albuterol/salbutamol
Intervention descriptions: intervention 1: Beclomethasone dipropionate (BDP) breath-actuated inhaler (BAI) given in dosages of either 40 mcg/inhalation or 80 mcg/inhalation. Study drug was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order. intervention 2: Placebo was provided in matching breath-actuated inhaler (BAI) devices. The placebo devices were identical to the devices used to deliver active drug. Placebo was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order. intervention 3: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period

Protocol documents:
Clinical trial NCT00989261
Conditions: Acute Myeloid Leukemia
Keywords: AML AC220 acute FLT3 inhibitor kinase leukemia leukaemia myeloid relapsed refractory
Sponsor: Daiichi Sankyo
Start date: 2009-11-01; Completion date: 2014-12-31
Enrollment: 333 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
AC220 will be administered as a once daily oral solution given continuously as 28-day treatment cycles, without any rest periods, until disease progression, relapse, intolerance to the drug, or elective allogeneic hematopoietic stem cell transplantation (HSCT).

Detailed description:

Arms: arm 1: Participants ≥60 years of age who were relapsed after one first-line chemotherapy regimen (with or without consolidation) and after first complete remission \<12 months or are primary refractory to first-line chemotherapy received a starting dose of 200 mg/day quizartinib.

Exploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-)

After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day. arm 2: Participants ≥18 years of age (including participants ≥60 years of age) who were relapsed or refractory after one second-line (salvage) regimen or after hematopoietic stem cell transplant (HSCT) received a starting dose of 200 mg/day quizartinib.

Exploratory: FLT3-ITD (+) and FLT3-ITD (-) Confirmatory: FLT3-ITD (+) and FLT3-ITD (-)

After an amendment, male participants received a starting dose of 135 mg/day quizartinib and all females received a starting dose of 90 mg/day.
Interventions: intervention 1: Compound AC220
Intervention descriptions: intervention 1: Precomplexed powder in bottle formulation supplied as 200 mg in a 60 cc polyethylene terephthalate (PET) plastic bottle. Requires reconstitution by a pharmacist, must be stored securely, and protected from light.

Protocol documents:
Clinical trial NCT00837902
Conditions: Healthy
Keywords: Atenolol Exercise Genotype Healthy volunteers
Sponsor: Vanderbilt University
Start date: 2009-01-01; Completion date: 2014-12-31
Enrollment: 154 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The overall goal of this project is to determine the genetic factors contributing to interindividual differences in response to beta-blockade.

Detailed description:
The Aim is to define the contribution of genetic variation to the interindividual variability in response to β-blockade. The rationale for the study is as follows: Beta-blockers prevent the activation of β-ARs and thus form the cornerstone of treatment of pathological states such as congestive heart failure and coronary artery disease. Functional polymorphisms in cardiac beta-receptors have been shown to determine response to β-blocker therapy. A physiologic stimulus such as exercise causes sympathetic stimulation and activation of the cardiac β-ARs and genotypic differences in response to β-blockers are magnified under states of heightened sympathetic activity. Thus, in addition to measuring the response to β-blockers at rest, we will also determine the response to β-blockade after sub-maximal exercise on a supine bicycle ergometer. Genetic variations that may alter sensitivity to a beta blocker will be sought.

Arms: arm 1: There is only 1 arm to this study. Intervention: All participants received atenolol. Genotyping for GRK5 was performed to identify if participants were GLN/GLN, GLN/LEU, or LEU/LEU.

Heart rates were measured at rest, and as participants performed graded incremental exercise on a supine bicycle ergometer (at 25, 50, and 75 W for 2 minutes each) twice, once before and once 2.5 hours after taking 25 mg of atenolol.
Interventions: intervention 1: Atenolol (β-blocker)
Intervention descriptions: intervention 1: 25 mg tablet

Protocol documents:
Clinical trial NCT01349673
Conditions: Proctitis Proctosigmoiditis
Keywords: Open-label Proctitis Proctosigmoiditis Ulcerative Salix Budesonide foam Budesonide Rectal Gastrointestinal Colitis UC UP UPS Additional relevant MeSH terms: Proctocolitis Ulcer Colitis, Ulcerative Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Rectal Diseases Intestinal Diseases Colonic Diseases Sigmoid Diseases Pathologic Processes Inflammatory Bowel Diseases Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes and Hormone Antagonists Anti-inflammatory Agents
Sponsor: Bausch Health Americas, Inc.
Start date: 2011-05-31; Completion date: 2014-12-31
Enrollment: 114 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate safety and tolerability of cyclically-dosed rectal budesonide foam in participants with active ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS).

Detailed description:
This is a Phase 3, multicenter, open-label study in participants who previously participated in a Salix-sponsored budesonide rectal foam study for the treatment of UP or UPS. Approximately 300 participants were to be enrolled into the study and receive budesonide foam cyclically for 6 weeks (twice a day \[BID\] for 2 weeks and once daily \[QD\] for 4 weeks). The study was to continue until regulatory approval of budesonide foam occurred or the sponsor decided to terminate the study.

Arms: arm 1: Participants administered topical rectal budesonide foam at 2 mg/25 mL BID (morning and 12 hours later) for 2 weeks followed by 2 mg/25 mL QD (in the evenings) for 4 weeks for up to 8 cycles. After Cycle 1, participants needed to qualify to be able to participate in subsequent cycles. Participants underwent a 48-hour study drug washout period between each cycle.
Interventions: intervention 1: Budesonide Foam
Intervention descriptions: intervention 1: Topical

Protocol documents: