ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01237353
Conditions: Pharmacodynamic
Sponsor: University of California, San Francisco
Start date: 2011-03-01; Completion date: 2011-07-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this study the investigators will test a nutritional supplement called betaine hydrochloride to see if it can temporarily increase the stomach acid in healthy volunteers who have decreased stomach acid because they take a medicine called rabeprazole.

Detailed description:
Investigators will evaluate the extent and time course of gastric re-acidification after oral betaine HCl in healthy volunteers with pharmacologically-induced hypochlorhydria. After betaine HCl dose, gastric pH will be continuously monitored for 2 hours.

Arms: arm 1: None
Interventions: intervention 1: betaine hydrochloride intervention 2: Rabeprazole
Intervention descriptions: intervention 1: betaine hydrochloride 1500mg po x 1 on day 5 intervention 2: rabeprazole po daily x 5 days

Protocol documents:
Clinical trial NCT01239212
Conditions: Seizures
Keywords: seizures neonate levetiracetam Epilepsy central nervous system diseases anticonvulsants
Sponsor: Children's Hospital Medical Center, Cincinnati
Start date: 2010-09-01; Completion date: 2011-07-01
Enrollment: 7 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to determine the pharmacokinetic profile of a 50 mg/kg loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of a 50 mg/kg loading dose of levetiracetam in term and preterm infants with seizures, and to obtain data on steady state drug levels of levetiracetam in neonates.

Detailed description:

Interventions: intervention 1: levetiracetam
Intervention descriptions: intervention 1: 50 mg/kg single loading dose of IV levetiracetam

Protocol documents:
Clinical trial NCT01243320
Conditions: Healthy
Sponsor: University of Utah
Start date: 2010-12-01; Completion date: 2011-07-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Nanotechnology is the controlled generation and manipulation of matter in dimensions less than 100 nm. Silver has been used for its bactericidal properties. The investigators propose to study the American Biotech Laboratory 32 ppm silver solution over a 14-day period in human volunteers to determine the toxicity and to quantify cytochrome P450 enzyme effects of this solution.

Detailed description:

Arms: arm 1: Oral Dose of 10ppm arm 2: Oral Dose of 32ppm
Interventions: intervention 1: 10ppm Oral Silver Particle intervention 2: 32ppm Oral Silver Particle
Intervention descriptions: intervention 1: Silver nanoparticles at 10ppm intervention 2: Silver nanoparticles at 32ppm

Protocol documents:
Clinical trial NCT01244425
Conditions: Bleeding (Oozing) in Hepatic Resection
Sponsor: Baxter Healthcare Corporation
Start date: 2010-11-01; Completion date: 2011-07-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare safety and efficacy of Fibrin Sealant (FS) Vapor Heated (VH) S/D 500 s-apr with manual compression as a supportive treatment of local bleeding (i.e. oozing) in hepatic resection surgery when standard surgical techniques are insufficient.

Detailed description:

Arms: arm 1: Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment. arm 2: A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
Interventions: intervention 1: Fibrin Sealant (FS) VH S/D 500 s-apr intervention 2: Manual compression
Intervention descriptions: intervention 1: Dosage form: spray application; dosage frequency: single application intervention 2: Dosage form: surgical gauze swab; dosage frequency: single application

Protocol documents:
Clinical trial NCT01246011
Conditions: Coronary Artery Bypass Graft Surgery Presence of Heparin/Platelet Factor 4 Antibody
Sponsor: Massachusetts General Hospital
Start date: 2010-11-01; Completion date: 2011-07-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Heparin/Platelet Factor 4 (PF4) antibody testing will be performed in subjects who have just undergone coronary artery bypass grafting (CABG) surgery. 30 subjects with a positive antibody result and no signs or symptoms of Heparin Induced Thrombocytopenia (HIT) will be randomized to receive argatroban and warfarin. 30 subjects with a positive antibody result and no signs or symptoms of HIT will be randomized to receive no treatment. 30 subjects with a negative antibody result will also be followed in the study. All subjects will have a cardiac CT scan at about 30 days post surgery to measure the patency of their coronary artery bypass vein grafts. This study will evaluate if treating patients who have heparin PF4 antibodies post-CABG with argatroban and warfarin has any effect on the short-term patency of coronary artery bypass vein grafts.

Detailed description:
This is a prospective, randomized, single center study. Patients scheduled for CABG will be screened and enrolled. Subjects positive for heparin/PF4 antibody within 24 h after CABG and without clinical suspicion of HIT will be randomized into one of two groups. An additional 30 patients with negative antibody titers will serve as a control group.

Arms: arm 1: Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin arm 2: Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication arm 3: Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication
Interventions: intervention 1: Argatroban and warfarin
Intervention descriptions: intervention 1: Subjects with the presence of heparin PF4 antibodies without signs or symptoms of HIT post CABG will be randomized to receive argatroban and warfarin or no drug for one month.

Protocol documents:
Clinical trial NCT01251354
Conditions: Endometrial Cancer
Sponsor: Ipsen
Start date: 2010-11-01; Completion date: 2011-07-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the protocol is to determine the effect of BN83495 on the progression of endometrial cancer with estrogen receptor in post menopausal women who had previously received chemotherapy.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: BN83495
Intervention descriptions: intervention 1: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops

Protocol documents:
Clinical trial NCT01251770
Conditions: Hyponatremia
Keywords: Hyponatremia Water-Electrolyte Imbalance
Sponsor: Hospital General de Niños Pedro de Elizalde
Start date: 2010-12-01; Completion date: 2011-07-01
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the blood sodium level after 12 hours following the initiation of therapy with either 0.3% NaCl/dextrose 5% or 0.45% NaCl/dextrose 5%, in postsurgical hospitalized children requiring maintenance IV fluid administration.

Detailed description:
Background: Despite prescription of maintenance IV fluids in hospitalized children is widely used since 1957 (Holiday \& Segar), it is not always adequate for children with acute diseases, leading to hyponatremia. This mainly occurs due to a non-physiologic ADH secretion in this group of patients due to nausea, stress, pain, and surgical interventions, and the use of hypotonic maintenance IV fluids.

0.3% NaCl/dextrose 5%, is widely use as IV maintenance fluid in children after surgery. There is evidence suggesting that these IV fluids used in postsurgical hospitalized patients do not provide the adequate amount of sodium they require, leading to an increased risk of developing hyponatremia. Using 0.45% NaCl/dextrose 5% as IV maintenance fluid in these children would prevent hyponatremia, but this treatment has not been totally studied yet.

Study procedures: Hospitalized children who fulfill inclusion criteria and not having any of the exclusion criteria will be considered for the enrolment after written informed consent.

Venous blood samples will be taken at enrollment (baseline) for estimation of serum sodium. After randomization, one group will receive 0.3% NaCl/dextrose 5%, IV, at standard maintenance rate (100 ml/kg for the first 10 kg of body weight, 50 ml/kg for the next 10 kg, and 20 ml/kg for body weight exceeding 20 kg). The second group will receive 0.45% NaCl/dextrose 5%, IV, at the same rate.

Serum sodium will be estimated in both groups after 12 hours of intravenous fluid therapy.

Children who required oral fluids will be excluded from per-protocol analysis, and only analyzed for intention to treat.

Arms: arm 1: Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids. arm 2: Subjects in this arm will receive 0.3% NaCl/dextrose 5% intravenous (IV) maintenance fluids.
Interventions: intervention 1: 0.45% NaCl/dextrose 5% intervention 2: 0.3% NaCl/dextrose 5%
Intervention descriptions: intervention 1: Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids.Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m\^2 body surface. intervention 2: Drug: 0.3% NaCl/dextrose 5% IV maintenance fluids. Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m\^2 surface.

Protocol documents:
Clinical trial NCT01253824
Conditions: Healthy
Keywords: NPC-01 IKH-01 Pharmacodynamics Norethisterone Ethinyl Estradiol Estradiol Progesterone FSH LH
Sponsor: Nobelpharma
Start date: 2011-01-01; Completion date: 2011-07-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the serum levels of estradiol, progesterone, FSH and LH in NPC-01 or IKH-01 one treatment cycle with those in before and after administration cycle.

Detailed description:

Arms: arm 1: 1mg norethisterone and 0.02mg ethinyl estradiol arm 2: 1mg norethisterone and 0.35mg ethinyl estradiol
Interventions: intervention 1: NPC-01 intervention 2: IKH-01
Intervention descriptions: intervention 1: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol intervention 2: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol

Protocol documents:
Clinical trial NCT01256086
Conditions: Asthma
Sponsor: MEDA Pharma GmbH & Co. KG
Start date: 2010-12-01; Completion date: 2011-07-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to estimate the relative potency for bronchoprotective effect of formoterol Novolizer 12 µg (test) compared to formoterol Aerolizer 12 µg (reference).

Detailed description:

Arms: arm 1: 12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 arm 2: 12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 arm 3: Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2 arm 4: Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2
Interventions: intervention 1: Formatris 24µg intervention 2: Formatris 12µg intervention 3: Foradil P 24µg intervention 4: Foradil P 12µg
Intervention descriptions: intervention 1: 12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 intervention 2: 12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 intervention 3: Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2 intervention 4: Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2

Protocol documents:
Clinical trial NCT01256450
Conditions: Pain Low Back Pain
Keywords: buccal soluble film enriched enrollment randomized withdrawal
Sponsor: BioDelivery Sciences International
Start date: 2010-11-01; Completion date: 2011-07-01
Enrollment: 334 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).

Detailed description:
This is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-controlled treatment period of 12 weeks. During the double-blind treatment period, this study will evaluate the effectiveness of buprenorphine HCl buccal film versus placebo buccal film in treating CLBP in subjects.

Buprenorphine HCl buccal film is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic opioid that is classified as a partial µ-receptor agonist and a Schedule III controlled substance in the United States.

Arms: arm 1: buprenorphine buccal soluble film arm 2: placebo buccal soluble film
Interventions: intervention 1: Buprenorphine intervention 2: Placebo
Intervention descriptions: intervention 1: buccal soluble film; applied to the buccal mucosa twice daily intervention 2: buccal soluble film; applied to the buccal mucosa twice daily

Protocol documents:
Clinical trial NCT01272804
Conditions: Diabetes Mellitus, Type 2 NIDDM
Keywords: Pharmacokinetics PK Pharmacodynamics PD T2DM Phase 1 Type 2 diabetes mellitus safety and tolerability
Sponsor: Pfizer
Start date: 2011-02-01; Completion date: 2011-07-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-04937319 following multiple (14 days) escalating oral doses in patients with type 2 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PF-04937319 intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will be dosed with PF-04937319 for 14 days. The doses planned are 10, 30, 100 and 300 mg QD. All doses will be administered as tablets (10 and 100 mg strengths). In each Cohort, 9 patients will receive PF 04937319 and 3 will receive placebo. An additional cohort of 12 patients (9 active, 3 placebo) may be performed to explore a QD or BID dose. The dose for this additional cohort could be a dose already studied or a new dose that is within the exposure stopping criteria. intervention 2: Placebo to match PF-04937319 will be provided. Subjects will be dosed for 14 days. In each cohort 9 subjects will receive PF-04937319 and 3 will receive placebo.

Protocol documents:
Clinical trial NCT01272947
Conditions: Acute Blunt Soft Tissue Injuries/Contusions
Keywords: Blunt soft tissue injury/contusion
Sponsor: Novartis
Start date: 2011-01-01; Completion date: 2011-07-01
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied four times a day in subjects with acute blunt soft tissue injuries/contusions of the limbs

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Diclofenac sodium intervention 2: Placebo
Intervention descriptions: intervention 1: Topical gel 1%- 4 times daily intervention 2: Topical gel - 4 times daily

Protocol documents:
Clinical trial NCT01283022
Conditions: Cervical Ripening Induction of Labor
Keywords: Pharmacokinetics Misoprostol Vaginal Insert Induction of labor Cervical Ripening Rate of Cesarean section
Sponsor: Ferring Pharmaceuticals
Start date: 2011-05-01; Completion date: 2011-07-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the pharmacokinetics (PK) of misoprostol acid for the MVI 200 in women requiring cervical ripening and induction of labor.

Detailed description:

Arms: arm 1: MVI 200 mcg vaginal insert
Interventions: intervention 1: MVI 200
Intervention descriptions: intervention 1: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.

Protocol documents:
Clinical trial NCT01285518
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes intravenous single dose
Sponsor: Pfizer
Start date: 2011-02-01; Completion date: 2011-07-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics and pharmacodynamics of single escalating doses of PF-05231023.

Detailed description:

Arms: arm 1: None arm 2: 0.9% w/v sodium chloride injection, USP
Interventions: intervention 1: PF-05231023 intervention 2: PF-05231023 intervention 3: PF-05231023 intervention 4: PF-05231023 intervention 5: PF-05231023 intervention 6: PF-05231023 intervention 7: PF-05231023 intervention 8: Placebo
Intervention descriptions: intervention 1: 0.5 mg QD IV x 1 day intervention 2: 1.5 mg QD IV x 1 day intervention 3: 5 mg QD IV x 1 day intervention 4: 15 mg QD IV x 1 day intervention 5: 50 mg QD IV x 1 day intervention 6: 100 mg QD IV x 1 day intervention 7: 200 mg QD IV x 1 day intervention 8: 0.9% w/v sodium chloride injection, USP QD IVx 1 day

Protocol documents:
Clinical trial NCT01298778
Conditions: Other Chronic Postoperative Pain
Keywords: chronic pain post delivery postpartum depression tailored pain management
Sponsor: Wake Forest University Health Sciences
Start date: 2010-08-01; Completion date: 2011-07-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In previous studies the investigators have seen that the severity of pain one day after cesarean delivery can predict the presence of pain and depression 2 months later. The investigators believe those at risk for severe acute post-partum pain can be identified, and medical interventions can be tailored to manage postoperative pain more effectively.

Detailed description:
This study is randomizing patients into 2 different groups and seeing if by altering our pain management with this group of patients their acute 24 hour evoked pain is less than anticipated; and the incidence of persistent pain and depression when contacted 2 months after delivery is decreased. This study is designed to see if these additional interventions would prove effective for patients at risk of having high pain level after cesarean surgery.

Arms: arm 1: Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. arm 2: Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.
Interventions: intervention 1: Duramorph 150 intervention 2: Acetaminophen intervention 3: Duramorph 300
Intervention descriptions: intervention 1: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses intervention 2: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses intervention 3: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses

Protocol documents:
Clinical trial NCT01299454
Conditions: Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2010-12-01; Completion date: 2011-07-01
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate how much of the investigational product gets into the blood stream and how long the body takes to get rid of it when given to subjects with a range of liver impairment compared to subjects with normal liver function.

Detailed description:
This is a multi-center, open-label, parallel-arm study in 1 group of subjects with normal hepatic function and 3 groups of subjects with varying degrees of hepatic impairment (mild, moderate, and severe). Subjects will be confined to the clinic from Day -1 to Day 8. Subjects will be contacted via telephone 30 days (+ 2 days) after the last dose of study medication to assess any new or ongoing AEs and to record concomitant medications. All groups will receive a single oral 2-mg OPC-34712 dose on Day 1 with 240 mL room temperature still water. Subjects will be administered the OPC-34712 dose in the fasted state (at least 8 hours of fasting) and no food will be allowed for 4 hours postdose.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: OPC-34712
Intervention descriptions: intervention 1: All groups will receive a single oral 2-mg OPC-34712 dose on Day 1 with 240 mL room temperature still water. Subjects will be administered the OPC-34712 dose in the fasted state (at least 8 hours of fasting) and no food will be allowed for 4 hours postdose. Water will be restricted as part of the dosing procedure from 1 hour prior to dosing and 2 hours post-dose.

Protocol documents:
Clinical trial NCT01299805
Conditions: Healthy
Keywords: Drug Therapy pharmacodynamic
Sponsor: Takeda
Start date: 2011-03-01; Completion date: 2011-07-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the pharmacodynamics (the drug's effect on the body), the pharmacokinetics (the body's handling of the drug), and the safety and tolerability of vortioxetine, once daily (QD) in healthy men.

Detailed description:
This study will look at an investigational medicine called vortioxetine to see how the drug affects the body and how the body handles the drug.

The study enrolled 17 patients. Participants were randomly assigned at a 2:1 ratio to one of the following two treatment groups-which remained undisclosed to both the participant and study doctor during the study (unless there was an urgent medical need):

* Vortioxetine 20 mg
* Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but had no active ingredient.

All participants were asked to take one capsule at the same time each day throughout the study.

This single-center trial was conducted in the United States. The overall time to participate in this study was approximately 7 weeks. Participants made 2 visits to the clinic, including 18 days confinement to the clinic, and were contacted by telephone 1 day and 27 days after leaving confinement for a follow-up assessment.

Arms: arm 1: Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days. arm 2: Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
Interventions: intervention 1: Vortioxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Encapsulated tablet intervention 2: Vortioxetine placebo-matching capsules.

Protocol documents: