ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT03331315
Conditions: Pain, Postoperative
Sponsor: Michael Ulm, MD
Start date: 2013-09-01; Completion date: 2017-01-01
Enrollment: 170 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized control trial between ketorolac versus celecoxib for postoperative pain following hysterectomy.

Detailed description:
Purpose:

To determine if Celebrex (Celecoxib) is as effective as Toradol (Ketorolac) at controlling postoperative pain when given in addition to standard postoperative pain control regimens.

Rationale:

Toradol (Ketorolac) is currently used by many surgeons as adjuvant therapy in addition to standard narcotics in managing immediate postoperative pain. Toradol (Ketorolac) is a non-steroidal anti-inflammatory drug that acts as a non-selective cyclooxygenase (COX), inhibiting COX-1 and COX-2 isoforms. (Toradol) Ketorolac has been associated with significant complications including postoperative bleeding and acute renal insufficiency. Celebrex (Celecoxib) is a selective COX-2 inhibitor that has been associated with adverse cardiovascular outcomes in patients with pre-existing cardiac disease but not with postoperative bleeding or renal insufficiency. Celebrex (Celecoxib) has also been shown to control postoperative pain but has never been compared to Toradol (Ketorolac).

Population:

Patients undergoing hysterectomy on the gynecology oncology service.

Design:

Randomized control trial.

Procedures:

All patients will receive a standard postoperative pain regimen with oral Tylenol (Acetaminophen), oral Lortab (Hydrocodone/Acetaminophen) as needed, and IV Dilaudid (Hydromorphone) as needed.

Randomization: Each participant will be assigned a number using a random number generator for assignment to one of the two postoperative pain regimens:

Arm 1:

Patients ages 18-65 will receive IV Toradol (Ketorolac) 30mg q6 hrs after their operation for 48 hrs or until hospital discharge if patients are discharged home in less than 48 hours after their operation.

\*\*Patients over age 65 will receive IV Toradol (Ketorolac) 15mg q6hrs instead of 30mg

Arm 2:

Patients who will receive oral Celebrex (Celecoxib) 400mg 1 hour prior to their procedure then 200mg oral twice daily for a total of seven days. Patients discharged prior to 7 days will be given a prescription for Celebrex (Celecoxib) to complete a total of 7 days.

Following surgery all patients will be given a postoperative questionnaire at the day of surgery, which was returned at the two week postoperative visit, examining time until return to ADLs, days of narcotic use, and number of narcotic pills used.

Arms: arm 1: Patients receiving scheduled ketorolac postoperatively arm 2: Patients receiving celebrex preoperative and postoperatively for 7 days
Interventions: intervention 1: Celecoxib intervention 2: Ketorolac
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02432690
Conditions: Cancer Ovarian Cancer
Keywords: Neoplasms
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2015-06-01; Completion date: 2017-01-02
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was an open-label, single-arm, Phase II study in which amcasertib (BBI503) was administered to adult, asymptomatic patients with recurrent ovarian cancer who had elevated CA-125.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: BBI503
Intervention descriptions: intervention 1: BBI503 will be administered orally, once daily. Dosing will begin at 200 mg once daily, preferably at bedtime and 2 hours after a meal. Dose modification in case of adverse events is allowed according to the schedule below; Full dose: 200 mg daily, Modification Level-1: 100 mg daily, Modification Level-2: 50 mg daily.

Protocol documents:
Clinical trial NCT02639338
Conditions: Hepatitis C Virus Infection
Keywords: Chronic
Sponsor: Gilead Sciences
Start date: 2015-12-23; Completion date: 2017-01-02
Enrollment: 220 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in participants naive to direct-acting antivirals (DAA) with chronic genotype 3 hepatitis C virus (HCV) infection and cirrhosis.

Detailed description:

Arms: arm 1: SOF/VEL/VOX tablet for 8 weeks arm 2: SOF/VEL tablet for 12 weeks
Interventions: intervention 1: SOF/VEL/VOX intervention 2: SOF/VEL
Intervention descriptions: intervention 1: 400/100/100 mg FDC tablet administered orally once daily with food intervention 2: 400/100 mg FDC tablet administered orally once daily without regard to food

Protocol documents:
Clinical trial NCT01956110
Conditions: Infertility
Sponsor: Ferring Pharmaceuticals
Start date: 2013-10-01; Completion date: 2017-01-03
Enrollment: 1329 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial investigates the effects of FE 999049 compared to GONAL-F.

Detailed description:

Arms: arm 1: Follitropin Delta (FE 999049) arm 2: Follitropin Alfa (GONAL-F)
Interventions: intervention 1: Follitropin Delta (FE 999049) intervention 2: Follitropin Alfa (GONAL-F)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01956123
Conditions: Infertility
Sponsor: Ferring Pharmaceuticals
Start date: 2014-03-26; Completion date: 2017-01-03
Enrollment: 513 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial investigates the immunogenicity of FE 999049 in repeated cycles.

Detailed description:

Arms: arm 1: Follitropin Delta (FE 999049) (COS cycle 2) arm 2: Follitropin Alfa (GONAL-F) (COS cycle 2) arm 3: Follitropin Delta (FE 999049) (COS cycle 3) arm 4: Follitropin Alfa (GONAL-F) (COS cycle 3)
Interventions: intervention 1: Follitropin Delta (FE 999049) intervention 2: Follitropin Alfa (GONAL-F)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02647281
Conditions: Hepatitis B
Keywords: Single dose Multiple ascending doses (MAD) Pharmacokinetics Safety GSK3389404 Tolerability
Sponsor: GlaxoSmithKline
Start date: 2015-12-17; Completion date: 2017-01-03
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a Phase 1, randomized, double-blind (Sponsor unblinded), placebo controlled, dose escalation study to determine the safety, tolerability and pharmacokinetics (PK) profile of GSK3389404 as single (Part 1) and multiple subcutaneous (SC) injections (Part 2) in healthy subjects. This study represents the first administration of GSK3389404 in humans to define the safety, tolerability and PK following single and multiple doses of GSK3389404 in healthy subjects.

Detailed description:

Arms: arm 1: Subjects will receive a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1. arm 2: Subjects will receive a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg. arm 3: Subjects will receive a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1. arm 4: Subjects will receive a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1. arm 5: Subjects will receive a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1. arm 6: Subjects will receive a single dose of GSK3389404 30 mg by subcutaneous injection QW for 4 weeks in Part 2. arm 7: Subjects will receive a single dose of subcutaneous injection of placebo matching with GSK3389404 30 mg or 60 mg or 120 mg once weekly (QW) for 4 weeks in Part 2. arm 8: Subjects will receive a single dose of GSK3389404 60 mg by subcutaneous injection QW for 4 weeks in Part 2. arm 9: Subjects will receive a single dose of GSK3389404 120 mg by subcutaneous injection QW for 4 weeks in Part 2.
Interventions: intervention 1: GSK3389404 intervention 2: Matching Placebo
Intervention descriptions: intervention 1: GSK3389404 is supplied as solution for injection vial. Each vial contains 100 mg/mL of GSK3389404. It's physical appearance is clear colourless to slightly yellow solution. intervention 2: Placebo is supplied as solution for injection vial. It's physical appearance is clear colourless solution.

Protocol documents:
Clinical trial NCT01094288
Conditions: Advanced Solid Tumors Adenocarcinoma of the Prostate
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2010-08-17; Completion date: 2017-01-04
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of alisertib in combination with docetaxel as a treatment for participants with advanced solid tumors, including castration-resistant prostate cancer, who were deemed by the investigator to be medically appropriate candidates for docetaxel therapy.

Detailed description:
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat people who have advanced solid tumors including castration-resistant prostate cancer.

The study enrolled approximately 41 patients. Participants were enrolled to receive:

• Alisertib 10-40 mg + docetaxel 60-75 mg/m\^2

All participants will receive alisertib (ECT) in dose escalating cohorts, orally, twice daily for 7 days followed by 14-day rest period in Cycle 1, 3 and onwards (21-day cycle) and orally twice daily from Day 3 to Day 7 followed by 14 day rest period in Cycle 2 \[dose held for pharmacokinetic (PK) collection\] along with docetaxel 75 mg/m\^2, intravenous (IV) infusion on Day 1 of each cycle for maximum of 12 months, or until the occurrence of progressive disease (PD), unmanageable AEs or withdrawal of consent.

This multi-center trial is conducted in United States. The overall time to participate in this study was until there is evidence of disease progression or unacceptable treatment-related toxicity. Participants made multiple visits to the clinic, and were contacted every 12 weeks for up to 25.8 months after last dose of study drug for a follow-up assessment.

Arms: arm 1: Alisertib in escalating dose (10-40 mg), enteric-coated tablets (ECT), orally, twice daily for 7 days followed by 14-day rest period in Cycle 1, 3 and onwards (21-day cycle) and orally twice daily from Day 3 to Day 7 followed by 14 day rest period in Cycle 2 along with docetaxel 60-75 mg/m\^2, intravenous (IV) infusion on Day 1 of each cycle for maximum of 12 months, or until the occurrence of progressive disease (PD), unmanageable adverse events (AEs) or withdrawal of consent.

The starting alisertib dose is 10 mg, orally, twice daily (total 20 mg/day).
Interventions: intervention 1: Alisertib intervention 2: Docetaxel
Intervention descriptions: intervention 1: Alisertib ECT intervention 2: Docetaxel IV infusion

Protocol documents:
Clinical trial NCT01564784
Conditions: Acute Lymphoblastic Leukemia
Sponsor: Pfizer
Start date: 2012-08-02; Completion date: 2017-01-04
Enrollment: 326 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: inotuzumab ozogamicin intervention 2: FLAG (fludarabine, cytarabine and G-CSF) intervention 3: HIDAC (high dose cytarabine) intervention 4: cytarabine and mitoxantrone
Intervention descriptions: intervention 1: Dose: inotuzumab ozogamicin 0.8-0.5 mg/m\^2 IV, weekly, 3 times per cycle Cycle length: 21-28 days Total number of cycles: 6 intervention 2: Dose: cytarabine 2.0 g/m\^2/day IV days 1-6 fludarabine30 mg/m\^2/day IV days 2-6 Cycle length: 28 days Total number of cycles: 4 intervention 3: cytarabine 3 g/m\^2 IV every 12 hours for up to 12 times intervention 4: mitoxantrone 12 mg/m\^2 IV days 1-3 cytarabine 200 mg/m\^2/day IV over 7 days cycle length: 15-20 days Total number of cycles: 4

Protocol documents:
Clinical trial NCT01404325
Conditions: Lung Transplantation
Keywords: Lung transplantation everolimus kidney function renal function
Sponsor: Novartis Pharmaceuticals
Start date: 2012-02-01; Completion date: 2017-01-05
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial evaluated the efficacy of an everolimus-based quadruple low immunosuppressive regimen versus a standard immunosuppressive regimen concerning kidney function in lung transplant recipients.

Detailed description:

Arms: arm 1: quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids arm 2: centre specific CNI-based triple drug immunosuppression (IS)
Interventions: intervention 1: standard therapy intervention 2: Everolimus
Intervention descriptions: intervention 1: centre specific CNI-based triple drug immunosuppression intervention 2: quadruple immunosuppressive regimen consisting of everolimus, CNI, MPA and steroids

Protocol documents:
Clinical trial NCT01945489
Conditions: Overactive Bladder
Sponsor: Allergan
Start date: 2013-10-28; Completion date: 2017-01-05
Enrollment: 254 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.

Detailed description:

Arms: arm 1: OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable). arm 2: Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
Interventions: intervention 1: onabotulinumtoxinA intervention 2: Normal saline
Intervention descriptions: intervention 1: OnabotulinumtoxinA (BOTOX®) injected into the detrusor. intervention 2: Normal saline (placebo) injected into the detrusor.

Protocol documents:
Clinical trial NCT02234115
Conditions: Prostatic Neoplasms
Keywords: Prostate Neoplasm Cancer Carcinoma
Sponsor: Foresee Pharmaceuticals Co., Ltd.
Start date: 2014-08-01; Completion date: 2017-01-05
Enrollment: 137 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with advanced prostate carcinoma, when administered as two injections six months apart.

Detailed description:
This is a multi-center, open-label, single-arm study conducted in 2 parts. Part I was established to provide a vanguard of the first 30 subjects who will have more frequent monitoring of their safety. If safety is established, the remainder of the subjects will be entered into the clinical study (i.e., Part II). All subjects will be males with advanced prostate carcinoma judged to be candidates for medical androgen ablation therapy, and all will receive two injections of LMIS 50 mg six-month apart in an unblinded fashion.

Arms: arm 1: All subjects will be males with advanced prostate carcinoma. They will be injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects will be followed until day 336.
Interventions: intervention 1: Leuprolide Mesylate
Intervention descriptions: intervention 1: Subcutaneous injection of 50mg Leuprolide Mesylate

Protocol documents:
Clinical trial NCT02628769
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Solithromycin Chronic Obstructive Pulmonary Disease Inflammation Macrolide
Sponsor: Imperial College London
Start date: 2015-07-01; Completion date: 2017-01-05
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study examines the potential benefit of a new antibiotic, Solithromycin, for the long-term treatment of Chronic Obstructive Pulmonary Disease (COPD). Solithromycin is hypothesised to work by reducing inflammation in the lungs of patients with COPD. Stable COPD patients will receive treatment with solithromycin for 28 days and comparisons will be made between any effects observed with Solithromycin and a placebo. This will include any changes in inflammatory proteins, lung function and reported symptoms.

Detailed description:
Chronic obstructive pulmonary disease (COPD) is a common and debilitating respiratory illness, that kills around 30,000 people annually in the UK. The primary risk factor is cigarette smoking, which causes inflammation in the air passages of the lungs. This inflammation is irreversible and results in progressive lung destruction. Currently, there are no effective anti-inflammatory medications available for COPD.

Inhalers remain the mainstay of regular treatment for COPD. Macrolide antibiotics however, are occasionally used as a supplementary treatment for some patients. They have been shown to be anti-inflammatory. However, concerns exist over the development of bacterial resistance to such antibiotics. Consequently they are not widely prescribed for COPD. Solithromycin is a new macrolide antibiotic, which has been shown to possess superior anti-inflammatory properties. Importantly, bacteria are far less likely to develop resistance to this new medication.

The current study will assess the effect of solithromycin as an anti-inflammatory treatment for COPD. 30 patients will be recruited to receive 28 days of treatment with solithromycin or placebo, followed by a 28 day wash out period (no study medication), before taking a further 28 days of treatment (the medication not taken first time around, i.e. either solithromycin or placebo). This study is a single-centre (Harefield Hospital), double-blind (study team and patient are not told what treatment they are taking), randomised (order in which solithromycin and placebo are taken), placebo-controlled and has a crossover design (subjects take both solithromycin and placebo separately). Sputum, blood and fluid from the nasal lining will be periodically sampled to examine any effect on the levels of inflammatory cells and proteins during the study. Any changes in lung function parameters or symptoms (COPD Assessment Test) will also be assessed.

Arms: arm 1: 28 day treatment of 400 mg Solithromycin taken once a day. arm 2: 28 day treatment with placebo taken once per day.
Interventions: intervention 1: Solithromycin intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01767467
Conditions: Herpes Zoster
Keywords: Immunogenicity Safety Herpes zoster Vaccination Haematologic malignancies
Sponsor: GlaxoSmithKline
Start date: 2013-03-01; Completion date: 2017-01-06
Enrollment: 568 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals' vaccine GSK1437173A in subjects aged 18 years and older with blood cancers. The study will evaluate safety-related events and antibody and cellular immune responses to the study vaccine, as compared to placebo.

Detailed description:
Amendment to protocol posting:

Increase in sample size, update of country/region-specific information (Sections 5, 6 and 9).

Promotion of secondary to primary objective; related update of primary and secondary outcome measures (Sections 4 and 7).

Arms: arm 1: Subjects will receive the candidate HZ vaccine (GSK 1437173A). arm 2: Subjects will receive the placebo vaccine.
Interventions: intervention 1: Herpes zoster vaccine (GSK 1437173A) intervention 2: Placebo
Intervention descriptions: intervention 1: 2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm. Dose 1 administered at Day 0. Dose 2 administered 1-2 months post Dose 1. intervention 2: 2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm. Dose 1 administered at Day 0. Dose 2 administered 1-2 months post Dose 1.

Protocol documents:
Clinical trial NCT02000427
Conditions: Relapsed/Refractory Philadelphia Positive B-precursor ALL
Keywords: Relapsed; Refractory; Philadelphia Positive; B-precursor; Acute Lymphoblastic Leukemia; ALL; Blinatumomab; Leukemia;
Sponsor: Amgen
Start date: 2014-01-03; Completion date: 2017-01-06
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective is to evaluate the rate of complete remission/complete remission with partial hematological recovery (CRh\*) in adults with relapsed/refractory Philadelphia chromosome positive (Ph+) B-precursor acute lymphoblastic leukemia (ALL) who receive blinatumomab.

Detailed description:
This is a single-arm Simon II stage design, multicenter study consisting of a screening period, an induction treatment period (2 cycles of blinatumomab), a consolidation treatment period (up to 3 additional cycles of blinatumomab for applicable participants), and a safety follow-up visit 30 days after treatment. Following the safety follow-up visit, participants will be followed for response duration and survival every 3 months for 18 months or death, whichever occurs first.

Arms: arm 1: Participants will receive blinatumomab by continuous intravenous (CIVI) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieve a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.

The initial dose will be 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 for all subsequent cycles of treatment.
Interventions: intervention 1: Blinatumomab
Intervention descriptions: intervention 1: Blinatumomab is administered as a continuous intravenous infusion (CIV). A single cycle of blinatumomab treatment is 6 weeks in duration, which includes 4 weeks of blinatumomab followed by a 2-week treatment-free interval.

Protocol documents: