ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01740089
Conditions: Hepatitis Hepatitis C
Keywords: Hepatitis C Cepeginterferon alfa Peginterferon Treatment
Sponsor: Biocad
Start date: 2011-11-01; Completion date: 2013-12-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to demonstrate the noninferiority of Algeron 1.5 and 2.0 μg/kg/week in combination with ribavirin compared to PegIntron in combination with ribavirin in the treatment of chronic hepatitis C, and to determine therapeutic dose of Algeron.

Detailed description:
After 12 weeks of treatment, an assessment of treatment efficacy was performed, i.e. rates of rapid (after 4 weeks) and early (after 12 weeks) virologic responses according to serum HCV RNA level PCR data. In patients without virologic response after 12 weeks, AVT was discontinued, and they were withdrawn from the study. Patients with EVR were enrolled in a follow-up period. During the follow-up period, patients of the first and the second group will receive Algeron in the selected therapeutic dose in combination with ribavirin, patients of the third group - PegIntron in combination with ribavirin during 12 or 36 weeks (depending on a genotype of the virus), afterwards they will be followed up without therapy for 24 weeks.

Arms: arm 1: Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg). arm 2: Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg). arm 3: PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight \< 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight \> 105 kg).
Interventions: intervention 1: Algeron intervention 2: PegIntron intervention 3: Ribavirin
Intervention descriptions: intervention 1: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously intervention 2: 1.5 μg/kg/week subcutaneously in combination with ribavirin intervention 3: 800-1400 mg/day orally

Protocol documents:
Clinical trial NCT01762501
Conditions: Hypertension
Keywords: Hypertension
Sponsor: Sogo Rinsho Médéfi Co., Ltd.
Start date: 2012-12-01; Completion date: 2013-12-01
Enrollment: 957 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the efficacy of Azilsartan 20 mg versus Amlodipine 5 mg oral administration once per day for 8 weeks in patients with grade I or grade II essential hypertension.

Detailed description:
Treatment

\<Run-in period\> Use of any antihypertensives, including azilsartan and amlodipine, is prohibited during the run-in period.

\<Treatment period\> Subjects who are considered eligible for participation in the study based on the results of eligibility assessment during the run-in period will be randomized to the azilsartan 20 mg or amlodipine 5 mg group at a ratio of 1:1 according to the following stratification factors; the type of awake-sleep blood pressure variation determined based on the data from ABPM at the start of run-in, complication status (chronic kidney diseases \[CKD\], type 2 diabetes), age, and sex.

Subjects will start treatment with either antihypertensive after examination for the start of treatment (Week 0) and visit the study site every 2 weeks, 5 visits in total, until the end of treatment (Week 8).

Subjects will orally take azilsartan 20 mg or amlodipine 5 mg, according to their group allocation, once daily before or after breakfast in the morning.

Arms: arm 1: Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks arm 2: Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks
Interventions: intervention 1: Azilsartan intervention 2: Amlodipine
Intervention descriptions: intervention 1: Azilsartan 20mg/day intervention 2: Amlodipine 5mg/day

Protocol documents:
Clinical trial NCT01765803
Conditions: Healthy Subjects
Keywords: Mellaril Thioridazine CD34+ Stem cells Progenitor cells Peripheral blood mobilization circulation
Sponsor: New Mexico Cancer Research Alliance
Start date: 2013-06-01; Completion date: 2013-12-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will investigate the possibility of using the drug thioridazine (also called Mellaril) to increase the number of certain types of cells moving from the bone marrow to the circulation in a group of healthy humans. The types of cells we hope to collect are called CD34+ progenitor, or stem cells. These cells can be used in the laboratory to better understand a number of diseases and suggest new strategies for therapy. Perhaps the most important potential application of human stem cells is the generation of cells and tissues that could be used for cell-based therapies, as a renewable source of replacement cells and tissues to treat diseases including Alzheimer's diseases, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis, and rheumatoid arthritis.

Detailed description:
This is a single-arm, feasibility study to test whether a single dose of Mellaril (thioridazine HCL) is able to effectively mobilize CD34+ cells in a set of health human subjects. This study does not involve the use of placebos, and subjects will serve as their own controls for CD34+ cell mobilization. We hypothesize that a single dose of Mellaril (thioridazine HCL) will mobilize CD34+ progenitor cells into human peripheral blood by a factor of at least 10 fold, from 4 to 40 cells/microliter.

Arms: arm 1: A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study
Interventions: intervention 1: Mellaril
Intervention descriptions: intervention 1: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment.

Protocol documents:
Clinical trial NCT01800162
Conditions: Persistent Pregnancy of Unknown Location Ectopic Pregnancy
Sponsor: University of Pennsylvania
Start date: 2013-02-01; Completion date: 2013-12-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized controlled trial to compare three currently available management strategies for women with a persisting pregnancy of unknown location (PPUL), which makes them at-risk for ectopic pregnancy. We will recruit hemodynamically stable women with a confirmed PPUL to be randomized to one of three strategies: 1) Uterine evacuation followed by methotrexate (MTX) for some (those that have evidence of a non visualized ectopic pregnancy) 2) Empiric treatment with MTX for all, and 3) Expectant management. Randomization will be 2:2:1 into these three arms. After randomization, they will be followed and treated clinically as is indicated by the progression of their condition. Primary outcome measures: uneventful decline of hCG to 5 IU/mL. Secondary outcome measures: re-interventions, treatment complications, health-related quality of life, financial costs, future fertility, and patient's preferences.

Detailed description:

Arms: arm 1: Subjects will undergo a uterine evacuation. If hCG levels do not sufficiently decrease after the uterine evacuation, the subject will be treated with methotrexate. If hCG levels do sufficiently decrease after the uterine evacuation, no further treatment is required. arm 2: Subjects will be treated with methotrexate, receiving one dose on day 0 and a subsequent dose on day 4. Additional doses will be administered as needed based on hCG levels. arm 3: Subjects will have their PPUL expectantly managed using serum hCG monitoring.
Interventions: intervention 1: Methotrexate intervention 2: Uterine Evacuation intervention 3: Expectant Management
Intervention descriptions: intervention 1: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels. intervention 2: Uterine evacuation or dilation and curettage. At the clinician's discretion, this can be performed using local anesthesia, sedation or general anesthesia and can use a manual or electrical evacuation. intervention 3: Pregnancy will be expectantly managed using serum hcg monitoring.

Protocol documents:
Clinical trial NCT01808248
Conditions: Hepatitis C
Keywords: HCV genotype 2 (GT-2) HCV genotype 3 (GT-3) HCV Sustained Virologic Response Direct Acting Antiviral Combination Therapy Treatment-Naïve GS-7977 Ribavirin RBV Peginterferon Alfa 2a PEG Additional relevant MeSH terms: Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Peginterferon alfa-2a Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs
Sponsor: Gilead Sciences
Start date: 2013-02-01; Completion date: 2013-12-01
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12 weeks in participants with chronic genotype 2 or 3 hepatitis C virus (HCV) infection who have previously failed prior treatment with an interferon-based regimen.

Detailed description:

Arms: arm 1: Participants will receive SOF+PEG+RBV for 12 weeks.
Interventions: intervention 1: SOF intervention 2: PEG intervention 3: RBV
Intervention descriptions: intervention 1: Sofosbuvir (SOF) 400 mg tablet administered orally once daily intervention 2: Peginterferon alfa 2a (PEG) 180 μg administered once weekly by subcutaneous injection intervention 3: Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents:
Clinical trial NCT01811706
Conditions: Spinocerebellar Ataxias Type 1 Spinocerebellar Ataxias Type 2 Spinocerebellar Ataxias Type 3 Spinocerebellar Ataxias Type 6
Sponsor: University of Florida
Start date: 2013-02-01; Completion date: 2013-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Investigators expect there will be improvement in walking speed and steadiness after taking Dalfampridine, thereby improving activities of daily living and enhancing social and occupational functions for patients with spinocerebellar ataxia.

Detailed description:
Twenty spinocerebellar ataxia patients will be randomized to receive either Dalfampridine or placebo over a total period of 10 weeks. After entering the study, patients will return every 2 weeks for evaluation. After four weeks, intervention will be stopped and patient will enter a 2-week wash out period where they do not take any drug. Then, patients will be given the opposite treatment (Dalfampridine or placebo) and this "crossover" study will be performed for another 4 weeks. Investigators expect there will be improvement in walking speed and steadiness after taking Dalfampridine, thereby improving activities of daily living and enhancing social and occupational functions.

Arms: arm 1: Participant first receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks. After a washout period of 2 weeks, they then receive Placebo tablet orally every 12 hours, for a 4 weeks period. arm 2: Participant first receive Placebo tablet orally every 12 hours, for a 4 weeks period. After a washout period of 2 weeks, they then receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks.
Interventions: intervention 1: Dalfampridine intervention 2: Placebo
Intervention descriptions: intervention 1: Dalfampridine will be provided at an oral dose of 10mg every 12 hours, for 4 weeks period intervention 2: Placebo will be administered orally every 12 hours, for a 4 week period.

Protocol documents:
Clinical trial NCT01841606
Conditions: Cardiac Output
Keywords: Spinal anesthesia Elective cesarean deliveries Ondansetron
Sponsor: University of British Columbia
Start date: 2013-03-01; Completion date: 2013-12-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Ondansetron is a medication routinely given to mothers having cesarean deliveries to help prevent and treat nausea and vomiting. The investigators are studying the hemodynamic effects of prophylactic ondansetron on parturients undergoing elective cesarean deliveries under spinal anesthesia.

Detailed description:
Spinal anesthesia is a routine anesthetic technique for elective cesarean deliveries. Although this provides safe and effective surgical anesthesia, it is not without side effects, including both hypotension and bradycardia. The incidence of hypotension following spinal anesthesia has been estimated to be as high as 80% in an obstetric population. A number of factors are also likely involved in the development of hypotension and bradycardia, including the Bezold-Jarisch Reflex (BJR).

Two human studies with spinal anesthesia, one in an obstetric population, have demonstrated ondansetron's ability to presumably attenuate the BJR and better prevent hypotension by antagonism of 5-HT3 receptors. Maintenance of blood pressure and heart rate are vitally important, as they are required for adequate perfusion of the fetus prior to delivery.

The investigators plan to investigate the hemodynamic effects of prophylactic ondansetron on parturients undergoing elective cesarean deliveries under spinal anesthesia.

Ondansetron is classified as a Pregnancy Category B drug by the FDA, meaning that no adverse fetal effects have been demonstrated in animal studies, but that there is a lack of well controlled studies in pregnant humans.

Arms: arm 1: 4mg of IV ondansetron 5 minutes prior to initiation of spinal anesthesia arm 2: 10mL of IV normal saline 5 minutes prior to initiation of spinal anesthesia
Interventions: intervention 1: Ondansetron intervention 2: Normal saline
Intervention descriptions: intervention 1: 4mg of IV ondansetron intervention 2: 10mL of IV normal saline

Protocol documents:
Clinical trial NCT01846702
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-05-01; Completion date: 2013-12-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3084077 in healthy participants. The study will also investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. The study is expected to last approximately 8 weeks for each participant.

Detailed description:

Arms: arm 1: Single dose of placebo matching LY3084077 administered subcutaneously (SC). arm 2: Single escalating doses (1 mg up to 300 mg) of LY3084077 administered SC.
Interventions: intervention 1: Placebo intervention 2: LY3084077
Intervention descriptions: intervention 1: Given as a SC injection. intervention 2: Given as a SC injection.

Protocol documents:
Clinical trial NCT01850823
Conditions: Seasonal Allergic Rhinitis
Sponsor: Actavis Inc.
Start date: 2013-02-01; Completion date: 2013-12-01
Enrollment: 880 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Compare the Clinical Equivalence of Mometasone Nasal Spray (Watson Laboratories, Inc) with NASONEX® Nasal Spray (Schering Corporation) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

Detailed description:

Arms: arm 1: Placebo arm 2: Mometasone Nasal spray arm 3: Mometasone Nasal spray
Interventions: intervention 1: placebo intervention 2: Mometasone Nasal Spray intervention 3: Mometasone nasal spray
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01861522
Conditions: Perennial Allergic Rhinitis
Keywords: TAU-284 Bepotastine besilate Histamine H1 receptor antagonists children
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2013-04-01; Completion date: 2013-12-01
Enrollment: 473 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are: to confirm the superiority of TAU-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis and to investigate safety of TAU-284.

Detailed description:
This is a randomized, double-blind, placebo-controlled, 2-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (20 mg/day) or placebo to pediatric patients with perennial allergic rhinitis, with "the change from baseline in total nasal symptom score (total score for the three major nasal symptoms \[sneezing, rhinorrhea, and nasal congestion\])" as the primary endpoint; and to investigate safety of TAU-284.

Arms: arm 1: Two TAU-284 5mg tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed). arm 2: Two placebo tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed).
Interventions: intervention 1: Bepotastine besilate intervention 2: Placebo
Intervention descriptions: intervention 1: Two TAU-284 5mg tablets will be taken orally twice a day intervention 2: Two Placebo tablets will be taken orally twice a day

Protocol documents:
Clinical trial NCT01863953
Conditions: Glaucoma Ocular Hypertension
Sponsor: Allergan
Start date: 2013-06-01; Completion date: 2013-12-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular hypertension.

Detailed description:

Arms: arm 1: One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks. arm 2: One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks. arm 3: One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Interventions: intervention 1: Fixed-Combination Bimatoprost/Brimonidine intervention 2: Bimatoprost Ophthalmic Solution 0.01% intervention 3: Vehicle Ophthalmic Solution intervention 4: Brimonidine Tartrate Ophthalmic Solution 0.2%
Intervention descriptions: intervention 1: One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks. intervention 2: One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening for 6 weeks. intervention 3: One drop vehicle ophthalmic solution in each eye in the morning daily for 6 weeks. intervention 4: One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.

Protocol documents:
Clinical trial NCT01868776
Conditions: Irreversible Pulpitis (Toothache)
Sponsor: Ohio State University
Start date: 2013-03-01; Completion date: 2013-12-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effect of buffered lidocaine (a numbing solution) on the ability to numb patients with toothaches. Buffered anesthetic (numbing) solutions have shown promise in some medical and dental research. Patients presenting with toothaches will be given either a buffered numbing solution or a nonbuffered numbing solution. Neither the patient nor the operator will know which solution they will receive. Root canal treatment will be performed on the tooth and the ability of the buffered versus non-buffered numbing solutions will be compared.

Detailed description:

Arms: arm 1: 4% lidocaine with 1:100,000 epinephrine/0.18 mEq/mL sodium bicarbonate. arm 2: 4% lidocaine with 1:100,000 epinephrine
Interventions: intervention 1: buffered lidocaine intervention 2: nonbuffered lidocaine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01871077
Conditions: Healthy
Sponsor: Laboratorios Sophia S.A de C.V.
Start date: 2013-09-01; Completion date: 2013-12-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate safety and tolerability of the ophthalmic solution PRO-156 over the ocular surface of ophthalmologically healthy volunteers

Detailed description:
A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of the ophthalmic solution PRO-143 over the ocular surface of ophthalmologically healthy volunteers.

Arms: arm 1: Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.
Interventions: intervention 1: PRO-156
Intervention descriptions: intervention 1: Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.

Protocol documents:
Clinical trial NCT01871402
Conditions: Plaque Psoriasis
Keywords: psoriasis lotion investigator's global assessment
Sponsor: Therapeutics, Inc.
Start date: 2013-05-01; Completion date: 2013-12-01
Enrollment: 221 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 3 study has been designed to determine and compare the efficacy and safety of 000-0551 Lotion and Vehicle Lotion applied twice daily for two weeks in subjects with plaque psoriasis.

Detailed description:

Arms: arm 1: Topical lotion, applied twice daily arm 2: Topical lotion, applied twice daily
Interventions: intervention 1: 000-0551 Lotion intervention 2: Vehicle Lotion
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: