ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01737944
Conditions: Rheumatoid Arthritis
Keywords: methotrexate injection, subcutaneous, autoinjector
Sponsor: Antares Pharma Inc.
Start date: 2011-01-01; Completion date: 2011-06-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Pharmacokinetics (PK) study

Detailed description:
To compare the pharmacokinetic (PK) profiles of methotrexate (MTX) following a subcutaneous (SC) injection of MTX using the Vibex device to that obtained after an SC injection of MTX without using the device and to that obtained after an intramuscular (IM) injection of MTX in adult subjects with rheumatoid arthritis (RA).

Arms: arm 1: Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection arm 2: Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection arm 3: Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection arm 4: Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection
Interventions: intervention 1: Methotrexate (MTX)
Intervention descriptions: intervention 1: Vibex MTX Device

Protocol documents:
Clinical trial NCT01773889
Conditions: Epithelial Ovarian Cancer Extraovarian Peritoneal Cancer Fallopian Tube Carcinoma
Keywords: Epithelial Ovarian Cancer FIGO (Int Federation of Gyn and Ob )Stage III or Stage IV Extraovarian Peritoneal Cancer Fallopian Tube Carcinoma Failing
Sponsor: The University of Texas Health Science Center at San Antonio
Start date: 2009-06-01; Completion date: 2011-06-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will test the hypothesis that adding pegylated IFN (IFN)a-2b to denileukin diftitox improves the potential of denileukin diftitox alone to deplete regulatory T cells (Tregs) and will thereby boost tumor immunity in patients with advanced-stage epithelial ovarian cancers, enhancing treatment efficacy.

Detailed description:
The aims of this study are to:

* Assess the efficacy of adding pegylated IFN-α2b to denileukin diftitox to treat selected advanced-stage epithelial ovarian cancers
* Test the immune-modulating effects of adding pegylated IFN-α2b to denileukin diftitox in ovarian cancer patients and relate them to clinical efficacy
* Identify any toxicity associated with pegylated IFN-α2b plus denileukin diftitox treatment in these patients
* Identify practical means to dose the immunomodulating agents denileukin diftitox and pegylated IFN-α2b based on immunopharmacodynamic metrics

Arms: arm 1: Administration of Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A
Interventions: intervention 1: Denileukin Diftitox/SC Pegylated IFNα-2a
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01300052
Conditions: Psoriasis
Keywords: psoriasis
Sponsor: Pfizer
Start date: 2011-01-26; Completion date: 2011-06-06
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether AN2728 topical ointment is a safe and effective treatment for mild-to-moderate plaque-type psoriasis.

Detailed description:

Arms: arm 1: AN2728 ointment, 2% arm 2: Ointment Vehicle
Interventions: intervention 1: AN2728 ointment, 2% intervention 2: Ointment Vehicle
Intervention descriptions: intervention 1: AN2728 ointment, 2%, applied twice daily for 12 weeks intervention 2: Ointment Vehicle, applied twice daily for 12 weeks

Protocol documents:
Clinical trial NCT00605215
Conditions: Multiple Sclerosis
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2008-04-24; Completion date: 2011-06-10
Enrollment: 1331 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study aims to compare the effect of daily oral treatment of laquinimod capsules 0.6 milligrams (mg) with the effect of placebo capsules (capsules that contain no active medication) as well as with the effect of an existing Multiple Sclerosis (MS) injectable drug: Interferon β-1a (Avonex®).

Detailed description:

Arms: arm 1: Participants will receive 1 capsule of placebo matching to laquinimod orally once daily for 24 months. arm 2: Participants will receive 1 capsule of laquinimod 0.6 mg orally once daily for 24 months. arm 3: Participants will receive an injection of Avonex® 30 micrograms (mcg) given intramuscularly (IM) once weekly for 24 months.
Interventions: intervention 1: Laquinimod intervention 2: Placebo intervention 3: Avonex®
Intervention descriptions: intervention 1: Laquinimod will be administered per dose and schedule specified in the arm description. intervention 2: Placebo matching to laquinimod will be administered per schedule specified in the arm description. intervention 3: Avonex® will be administered per dose and schedule specified in the arm description.

Protocol documents:
Clinical trial NCT01431989
Conditions: Infections, Bacterial
Sponsor: GlaxoSmithKline
Start date: 2011-05-27; Completion date: 2011-06-11
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods. The volunteers received, in each period, the reference or the test formulation, according to the randomization list, under fasting conditions, in order to evaluate if the reference and test formulations are bioequivalent.

Detailed description:
This study is prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods. The objective is to confirm if two formulations of Amoxicillin trihydrate, in the form powder for oral suspension, are bioequivalent. The test product is Amoxicillin trihydrate - Clamoxyl 500mg/5mL (Glaxo Wellcome Production.) in the form powder for oral suspension and reference product is Amoxil ® 500mg/5mL (GlaxoSmithKline Mexico SA) in the form of powder for oral suspension. Twenty eight healthy volunteers, of both genders, were evaluated. The volunteers received, in each period, the reference or the test formulation, according to the randomization list, under fasting conditions. In each period blood samples are collected in the following times: 0.00 (prior to administration of medication); 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 (after administration of medication). The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.

Arms: arm 1: Test product: Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL in Period 1; followed by 14-days washout period during which no medication was administered; followed by reference product: Amoxil® 500mg/5mL in Period 2. arm 2: Reference product: Amoxil® 500mg/5mL powder for oral suspension in Period 1; followed by 14-days washout period during which no medication was administered; followed by test product: Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL in Period 2
Interventions: intervention 1: Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL intervention 2: Amoxil® 500mg/5mL powder for oral suspension
Intervention descriptions: intervention 1: Test formulation intervention 2: Reference formulation

Protocol documents:
Clinical trial NCT00907517
Conditions: Myelogenous Leukemia, Acute Leukemia, Lymphocytic, Acute Leukemia, Lymphoblastic, Acute, Philadelphia-Positive Myelogenous Leukemia, Chronic, Aggressive Phase
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-07-29; Completion date: 2011-06-13
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study of SCH 900776 (MK-8776) will evaluate its safety and tolerability when given in combination with cytarabine to participants with acute leukemias. Participants in the Dose-Escalation Part will be enrolled in cohorts that will receive sequentially higher doses of MK-8776 in combination with standard doses of cytarabine. Only one combination treatment cycle of approximately 4 to 6 weeks is anticipated, but participants may receive additional cycles if clinically indicated after discussion between the Investigator and the Sponsor. The recommended combination doses for a Phase 2 trial (RP2D) will be determined based on safety and biological activity. Up to 10 to 15 additional participants will be studied at the combination RP2D.

Detailed description:

Arms: arm 1: Participants received MK-8776 10 mg/m\^2 intravenously (IV) on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour continuous intravenous infusion (CIV) on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge). arm 2: Participants received MK-8776 20 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge). arm 3: Participants received MK-8776 40 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge). arm 4: Participants received MK-8776 56 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge). arm 5: Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Interventions: intervention 1: MK-8776 intervention 2: Cytarabine
Intervention descriptions: intervention 1: IV infusion intervention 2: IV infusion

Protocol documents:
Clinical trial NCT01076400
Conditions: Cervical Cancer
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-05-31; Completion date: 2011-06-13
Enrollment: 7 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will be conducted in two parts. Part 1 will determine whether administration of adavosertib in combination with topotecan and cisplatin is generally well-tolerated and causes clinical objective responses in patients with cervical cancer. Part 1 will also define the recommended Phase 2 dose and maximum tolerated dose (MTD) of the combination of adavosertib with topotecan and cisplatin. Part 2 of the study will evaluate whether treatment with adavosertib in combination with topotecan and cisplatin causes an improvement in progression-free survival (PFS) compared to treatment with topotecan and cisplatin alone and will further evaluate the tolerability of the combination treatment. The primary hypothesis is the combination of adavosertib, topotecan and cisplatin causes objective radiological responses (assessed per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 criteria) in ≥30% of participants. Due to the early termination of the study by the sponsor, no participants were enrolled in Part 2 of the study.

Detailed description:

Arms: arm 1: Part 1: Dose escalation study. adavosertib capsules will be administered in sequentially rising dose levels twice daily for a total of nine doses on Days 1-5 of a 21-day cycle. Topotecan will be administered at a dosage of 0.75 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1-3 . Cisplatin will be administered at a dosage of 50 mg/m\^2 by IV infusion over 30 minutes on Day 1. arm 2: Part 2: adavosertib capsules will be administered at the dose determined in Part 1 twice daily for a total of nine doses on Days 1-5 of a 21-day cycle. Topotecan will be administered at a dosage of 0.75 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1-3. Cisplatin will be administered at a dosage of 50 mg/m\^2 by IV infusion over 30 minutes on Day 1. arm 3: Part 2: Placebo to adavosertib capsules will be administered twice daily for a total of nine doses on Days 1-5 of a 21-day cycle. Topotecan will be administered at a dosage of 0.75 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1-3. Cisplatin will be administered at a dosage of 50 mg/m\^2 by IV infusion over 30 minutes on Day 1.
Interventions: intervention 1: adavosertib intervention 2: Topotecan intervention 3: Cisplatin intervention 4: Placebo to adavosertib
Intervention descriptions: intervention 1: Adavosertib capsules are administered in sequentially rising dose levels twice daily for a total of nine doses on Days 1-5 of a 21-day cycle. intervention 2: Topotecan is administered at a dosage of 0.75 mg/m\^2 by intravenous (IV) infusion over 30 minutes on Days 1-3. intervention 3: Cisplatin is administered at a dosage of 50 mg/m\^2 by IV infusion over 30 minutes on Day 1. intervention 4: Placebo to adavosertib capsules are administered in sequentially rising dose levels twice daily for a total of nine doses on Days 1-5 of a 21-day cycle.

Protocol documents:
Clinical trial NCT01063881
Conditions: Sexual Dysfunction, Physiological
Keywords: Sexual Dysfunction, physiological R096769 Dapoxetine Phase 3b Premature Ejaculation
Sponsor: Janssen Research & Development, LLC
Start date: 2010-05-22; Completion date: 2011-06-14
Enrollment: 285 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to measure the efficacy of flexible dosing of dapoxetine in a setting similar to routine clinical practice.

Detailed description:
This is a prospective, interventional study to evaluate efficacy and safety of flexible dose dapoxetine as Premature Ejaculation (PE) Therapy. The total study duration will be 16 weeks, composed of a 2-week pretreatment phase and a 12-week open-label treatment phase, followed by a telephone contact two weeks after Week 12 to follow-up adverse events. At Visit 1 (Screening) standardized assessment tool or patient questionnaires will be used to determine which of those patients with erectile dysfunction/premature ejaculation are eligible to participate in this study. Once enrolled the patient and his partner are expected to attempt sexual intercourse a minimum of 2 times (at least 24 hours apart) and to complete a Baseline Event Log. Starting at Visit 2 (Baseline), the patient (and partner) will complete the Premature Ejaculation Profile (PEP) at the beginning of every treatment visit for the duration of the study. Patients will be started on study drug instructed to take 1 tablet of dapoxetine 30 mg, as needed, 1 to 3 hours prior to sexual activity. The need for adjustments in the dose of dapoxetine, as well as to assess the occurrence of adverse events and concomitant therapy use will be assessed approximately every 4 weeks. Patients will complete Treatment Event Logs during each dosing throughout the open-label treatment phase. Patients who have their dose increased to 60 mg, will be scheduled for a telephone consultation 1 week after to determine how the dose change is tolerated. At Visit 5 (Final Visit/Week 12/Early Termination), the patients and partners will complete several standardized assessment questionnaires have all final visit procedures performed and schedule a telephone follow up contact to evaluate any adverse events. The starting dose of dapoxetine is 30 mg (one 30-mg tablet), taken approximately 1 to 3 hours prior to sexual activity. The dose may be increased after 4 weeks to 60 mg taken. The maximum recommended dosing frequency is once every 24 hours.

Arms: arm 1: Starting dose is one 30-mg tablet taken approximately 1-3 hours prior to sexual activity may be increased after 4 weeks to 60mg taken for 12 weeks. The maximum recommended dosing frequency is once every 24 hours.
Interventions: intervention 1: Dapoxetine
Intervention descriptions: intervention 1: Starting dose is one 30-mg tablet taken approximately 1-3 hours prior to sexual activity, may be increased after 4 weeks to 60mg, taken for 12 weeks. The maximum recommended dosing frequency is once every 24 hours.

Protocol documents:
Clinical trial NCT01047007
Conditions: Solid Tumors
Keywords: Head and Neck Cancer Esophageal Cancer Gastric Cancer
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-01-18; Completion date: 2011-06-15
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The study evaluates safety of adavosertib in monotherapy, and in combination with 5-Fluorouracil (5-FU) alone or with 5-FU/cis-diamminedichloroplatinum (CDDP) in Japanese participants with solid tumor. The primary hypothesis is that adavosertib is safe and tolerable in participants with locally advanced or metastatic solid tumors.

Detailed description:

Arms: arm 1: Participants received 65 mg of adavosertib administered orally twice a day (BID) on Days 1-5 of a 21-day cycle. arm 2: Participants received 20 mg of adavosertib administered orally BID on Days 1-5 of a 21-day cycle and 1000 mg/m\^2/day of 5-FU administered as an intravenous (IV) infusion on Days 1-4 of a 21-day cycle. arm 3: Participants received 20 mg of adavosertib administered orally once a day (QD) on Days 1-5 of a 21-day cycle and 1000 mg/m\^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle. arm 4: Participants were to receive 20 mg or 65 mg of adavosertib administered either BID or QD on Days 1-5 of a 21-day cycle; 1000 mg/m\^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle; and 60 mg/m\^2 to 100 mg/m\^2 of CDDP administered as an IV infusion on Day 1.
Interventions: intervention 1: adavosertib 20 mg intervention 2: 5-FU 1000 mg/m^2/day intervention 3: CDDP intervention 4: adavosertib 65 mg
Intervention descriptions: intervention 1: Adavosertib 20 mg capsule administered orally on days 1-5 of a 21 day cycle. intervention 2: 5-FU 1000 mg/m\^2/day administered as an intravenous (IV) infusion on Days 1-4 of a 21-day cycle intervention 3: CDDP 60 mg/m\^2 to 100 mg/m\^2 administered as an IV infusion on Day 1. intervention 4: Adavosertib 65 mg capsule administered orally on days 1-5 of a 21 day cycle.

Protocol documents:
Clinical trial NCT01224145
Conditions: Hernia Postoperative Pain
Sponsor: Innocoll
Start date: 2011-03-22; Completion date: 2011-06-20
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess pain intensity for the first 72 hrs after aggravated movement (cough) following Laparoscopic Inguinal or Umbilical Herniorrhaphy.

Detailed description:
Inguinal herniorrhaphy is a common surgery; approximately 2,800 per million people in the United States (US) undergo the procedure annually.Common surgical methods of herniorrhaphy include open and laparoscopic placement of synthetic mesh. Studies have shown that the use of synthetic mesh greatly reduces the risk of hernia recurrence regardless of the method used for its placement. Furthermore, utilizing the laparoscopic approach for umbilical hernia repair, specifically with the use of mesh, may also reduce the risk of infection.

Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery.

This open-label study will assess pain intensity after surgery in patients who receive the CollaRx Bupivacaine implant as well as determine the feasibility of the use of the laparoscope for sponge placement in laparoscopic hernia repair.

Arms: arm 1: bupivacaine collagen sponges
Interventions: intervention 1: 5x5cm bupivacaine collagen sponges
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00997204
Conditions: Hereditary Angioedema
Keywords: HAE Type I HAE Type II HAE
Sponsor: Shire
Start date: 2009-09-25; Completion date: 2011-06-22
Enrollment: 151 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is being conducted to explore the clinical safety, local tolerability, convenience and effectiveness of self-treatment of hereditary angioedema (HAE) attacks with subcutaneous injections of icatibant.

Detailed description:
This Phase IIIb study was multi-center and open-label with a single dose level. Subjects with a documented diagnosis of HAE Type I or II were eligible to participate in this trial. Eligible subjects included those who had received treatment for HAE with icatibant in previous clinical trials, or subjects who had been previously treated with the marketed product Firazyr® and subjects who were naïve to icatibant treatment.

All subjects were trained on the method of self-administration at their enrollment visit (Visit 1).For the training sessions, a syringe pre-filled with 3 mL placebo solution was used in place of icatibant. Comprehensive educational material and instructions including pictograms were developed for the subjects to illustrate the method of self-administration and use of the Patient Diary. The training material provided additional information on how to self-diagnose an HAE attack and how to decide on the necessity to treat.In addition, instructions were provided on what to do in case of a laryngeal attack.

Arms: arm 1: Single subcutaneous injection of icatibant, 30 mg arm 2: Single subcutaneous injection of icatibant, 30 mg
Interventions: intervention 1: Icatibant
Intervention descriptions: intervention 1: Single subcutaneous injection of icatibant, 30 mg

Protocol documents:
Clinical trial NCT04534491
Conditions: Overactive Bladder
Sponsor: Bayer
Start date: 2010-05-25; Completion date: 2011-06-22
Enrollment: 855 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
With this study researchers want to gather information about the consumer use behavior of Oxytrol in a simulated setting in which the medicine is sold directly to a consumer without a prescription from a healthcare professional. An area of focus was on the potential benefits of an over-the-counter status for Oxytrol and on the ongoing use behavior of the consumers. Oxytrol is a thin, flexible, clear patch that is indicated for the treatment of overactive bladder a disease characterized by a collection of symptoms, including urinary frequency, urgency, and urge incontinence. The adhesive patch is placed on the skin to deliver Oxytrol through the skin into the bloodstream.

Detailed description:

Arms: arm 1: Subjects decided to purchase Oxytrol.
Interventions: intervention 1: Oxybutynin (Oxytrol, BAY839380)
Intervention descriptions: intervention 1: Oxybutynin transdermal patch, 3.9 mg daily (Oxytrol Transdermal System)

Protocol documents: