ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02758613
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2016-05-01; Completion date: 2016-07-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to investigate the safety and tolerability of the study drug known as baricitinib in healthy Chinese participants. The study will measure how the body absorbs, breaks down and gets rid of baricitinib. The study will last about 20 days, not including screening. This study is for research purposes only, and is not intended to treat any medical condition.

Detailed description:

Arms: arm 1: 2mg Baricitinib administered orally, once on Day 1 and once a day (QD) on Days 4 through 10 (7 days). arm 2: 4mg Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days). arm 3: 10mg Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days). arm 4: Placebo matching Baricitinib administered orally, once on Day 1 and QD on Days 4 through 10 (7 days).
Interventions: intervention 1: Baricitinib intervention 2: Placebo
Intervention descriptions: intervention 1: Administered orally. intervention 2: Administered orally.

Protocol documents:
Clinical trial NCT02770521
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2016-05-01; Completion date: 2016-07-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The aims of this study are to evaluate:

* The safety and tolerability of a single dose of treprostinil given subcutaneously (as an injection just under the skin)
* The pharmacokinetic profile (how the body absorbs, breaks down, and gets rid of) of a single subcutaneous dose of a new LY900014 formulation in healthy Japanese participants.

The study has two parts. Participants may only enroll in one part.

Detailed description:

Arms: arm 1: Treprostinil administered as a single subcutaneous (SC) bolus injection. arm 2: Placebo administered as a single SC bolus injection. arm 3: LY900014 (test) administered as a single SC bolus injection. arm 4: Insulin lispro (reference) administered as a single SC bolus injection.
Interventions: intervention 1: Treprostinil intervention 2: Placebo intervention 3: LY900014 intervention 4: Insulin Lispro
Intervention descriptions: intervention 1: Administered SC. intervention 2: Administered SC. intervention 3: Administered SC. intervention 4: Administered SC.

Protocol documents:
Clinical trial NCT02791308
Conditions: Atopic Dermatitis
Sponsor: Actavis Inc.
Start date: 2015-02-01; Completion date: 2016-07-01
Enrollment: 587 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and efficacy profiles of Watson Laboratories, Inc.'s Pimecrolimus Cream, 1% to those of Valeant Pharmaceuticals North America LLC's Elidel® (pimecrolimus) Cream, 1%, and to demonstrate the superior efficacy of the two active creams over that of the placebo (Vehicle of test product), in the treatment of mild to moderate atopic dermatitis.

Detailed description:
Pimecrolimus cream, 1% is a calcineurin inhibitor immunosuppressant. Pimecrolimus inhibits T cell activation by blocking the transcription of early cytokines. Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. This study is being conducted to evaluate the clinical bioequivalence of sponsor's formulation of Pimecrolimus Cream, 1%, the Test product, and Elidel Cream, 1%, the Reference product. A vehicle control arm is included to demonstrate that the Test and Reference products are active and to establish that the study is sufficiently sensitive to detect differences between products.

Arms: arm 1: Pimecrolimus Cream, 1% (Actavis) arm 2: Reference listed drug: Elidel 1% cream (Valeant Pharmaceuticals North America LLC) arm 3: Cream vehicle of the test product (Actavis)
Interventions: intervention 1: Pimecrolimus Cream 1% (Valeant) intervention 2: Vehicle cream intervention 3: Pimecrolimus Cream, 1%
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02815397
Conditions: Diffuse Large B-Cell Lymphoma
Keywords: Double Hit DLBCL
Sponsor: Rush University Medical Center
Start date: 2016-02-01; Completion date: 2016-07-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Newly diagnosed histologically confirmed c-myc+ de novo DLBCL. Metformin 500 mg daily x 1 week, then 500 mg twice daily (BID) x 2 weeks, then 850 mg twice daily until 1 month after last cycle of chemo-immunotherapy.

DA-EPOCH-R every 21 days x 4 cycles (CNS prophylaxis single or triple therapy given intrathecally each cycle to patients deemed appropriate by treating physician).

Restage after 4 cycles with CT. Complete remission or partial remission: complete 2 more cycles or radiation therapy (XRT) consolidation per physician. Stable or progressive disease will go on to salvage therapy off study.

Detailed description:
Subject admitted to in-patient care for day 1 or each cycle and discharged on day 5. On day 6, subject receives Rituximab in outpatient infusion facility.

Metformin is dispensed on day 1 of each cycle and taken as follows: Cycle 1 days 1-7 500 mg daily. Days 8-21, 500 mg twice daily. Cycle 2 through end of treatment, metformin given 850 mg twice daily.

Inpatient treatment: DA-EPOCH every 21 days Etoposide (VP-16) 50 mg/m2/d civi d1-4 (continuous infusion) Prednisone 60 mg/m2 BID po d1-5 Vincristine 0.4 mg/m2/d civi d 1-4 (continuous infusion) Doxorubicin (Adriamycin) 10 mg/m2/d civi d1-4 (continuous infusion) Cyclophosphamide (Cytoxan) 750 mg/m2 IV over 15 min d5 If clinically indicated, patients who are deemed appropriate for central nervous system (CNS) prophylaxis by their treating physician will receive either single agent intrathecal methotrexate (12 mg) or triple therapy (15 mg methotrexate, 30 mg cytarabine, 30 mg hydrocortisone) with each cycle of chemotherapy.

Rituximab 375 mg/m2 IV every 21 days on D6-8 post DA-EPOCH (per standard institutional guidelines) DA-dose adjustment paradigm based on twice weekly complete blood count (CBC) (dose adjustment above starting doses apply to Etoposide (VP-16), Doxorubicin (Adriamycin) and Cyclophosphamide (Cytoxan). If nadir absolute neutrophil count(ANC)\>500/microliter (uL), 20% increase in all 3 drugs. If nadir\<500/uL on 1 or 2 measurements, same doses as last cycle. If nadir \<500/uL on at least 3 measurements, or nadir platelet \<25,000/uL on 1 measurement, 20% decrease in Etoposide, Doxorubicin and Cyclophosphamide below last cycle.

Filgrastim (Neupogen) 5 mcg/kg sc qd beginning on d6 until ANC\>5,000/uL or Pegfilgrastim (Neulasta) 6 mg sc 24-72 hours post chemotherapy.

Restaging with CT scans is done after cycle 4 and:

complete remission (CR)/partial remission (PR) - complete 2 more cycles of therapy OR consolidation radiation therapy per treating physician.

stable disease (SD)/progressive disease (PD) - salvage therapy off study.

Arms: arm 1: Metformin added to standard of care treatment for all patients
Interventions: intervention 1: Metformin
Intervention descriptions: intervention 1: given in addition to standard of care treatment

Protocol documents:
Clinical trial NCT02844998
Conditions: Premature Ejaculation
Keywords: intravaginal ejaculatory latency time international physical activity questionnaire premature ejaculation diagnostic tool
Sponsor: Ankara Training and Research Hospital
Start date: 2015-01-01; Completion date: 2016-07-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the relationship between physical activity and PE, and determine whether moderate physical activity might delay ejaculation time or be an alternative treatment for PE.

Detailed description:

Arms: arm 1: Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand) arm 2: Patients who have sedentary life style will be advised moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week. (Minimally active category) arm 3: Patients who have sedentary life style will be advised those to walk (not running )at most 30 minutes for 5 days in a week. (Inactive category)
Interventions: intervention 1: physical activity intervention 2: dapoxetine 30 mg on demand
Intervention descriptions: intervention 1: patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week intervention 2: Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries

Protocol documents:
Clinical trial NCT01928940
Conditions: Solid Tumours
Keywords: Advanced solid tumors BRAF Melanoma
Sponsor: GlaxoSmithKline
Start date: 2013-08-15; Completion date: 2016-07-04
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Japanese Phase I/II, open-label, non-controlled study to evaluate the safety, tolerability, pharmacokinetic profile, and efficacy of the combination of GSK2118436 and GSK1120212 in subjects with BRAF V600E/K mutation positive advanced solid tumors (Phase I part) and BRAF V600E/K mutation positive cutaneous melanoma (Phase II part).

Detailed description:
This is a Japanese Phase I/II, open-label, non-controlled study to evaluate the safety, tolerability, pharmacokinetic profile, and efficacy of the combination of GSK2118436 and GSK1120212 in subjects with BRAF V600E/K mutation positive advanced solid tumors (Phase I part) and BRAF V600E/K mutation positive cutaneous melanoma (Phase II part). Phase I part is designed to primarily assess the safety and tolerability of GSK2118436 and GSK1120212 combination therapy in subjects with BRAF V600E/K mutation positive advanced solid tumors. Six evaluable subjects will be enrolled into Phase I part and receive the combination therapy of GSK2118436 (150 mg, twice daily) and GSK1120212 (2 mg, once daily). A decision for starting Phase II part will be made by careful review based on available safety, tolerability and pharmacokinetic data in Phase I part. Phase II part is designed to primarily evaluate ORR of the combination as first-line therapy in subjects with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation positive cutaneous melanoma. Subjects who have had prior systemic anti-cancer treatment in the advanced or metastatic setting will not be eligible for Phase II part although prior systemic treatment in the adjuvant setting will be allowed. Six evaluable subjects will be enrolled in Phase II part.

Arms: arm 1: Combination therapy of dabrafenib and trametinib
Interventions: intervention 1: dabrafenib intervention 2: trametinib
Intervention descriptions: intervention 1: 150 mg twice daily intervention 2: 2 mg once daily

Protocol documents:
Clinical trial NCT01941940
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2013-09-05; Completion date: 2016-07-05
Enrollment: 227 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single arm, Phase 3b study will evaluate the efficacy of tocilizumab (RoActemra), administered as monotherapy or in combination with methotrexate and/or other DMARDs, in participants with moderate to severe active RA.

Detailed description:

Arms: arm 1: Tocilizumab at a fixed dose of 162 milligrams (mg) will be administered as subcutaneous (SC) injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants can continue the study treatment with SC tocilizumab until it becomes commercially available in Italy.
Interventions: intervention 1: Tocilizumab intervention 2: DMARDs
Intervention descriptions: intervention 1: Tocilizumab at a fixed dose of 162 mg as SC injection will be administered once every week. intervention 2: Non-biologic DMARDs according to standard of care, at a stable dose that was initiated at least 4 weeks prior to baseline.

Protocol documents:
Clinical trial NCT02245620
Conditions: Skeletal Muscle Mitochondrial Dysfunction in the Elderly
Keywords: Skeletal muscle dysfunction, MTP-131, Bendavia™ elamipretide
Sponsor: Stealth BioTherapeutics Inc.
Start date: 2015-01-15; Completion date: 2016-07-06
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a Phase 2, randomized, double-blind, placebo-controlled study, enrolling 41 elderly subjects with previous evidence of mitochondrial dysfunction to evaluate whether the administration of MTP-131 (elamipretide) will change either hand skeletal muscle energetics or muscle performance in age-related skeletal muscle mitochondrial dysfunction.

Detailed description:
This was a Phase 2, randomized, double-blind, placebo-controlled study, enrolling 41 elderly subjects with previous evidence of mitochondrial dysfunction to evaluate whether the administration of MTP-131 (elamipretide) will change either hand skeletal muscle energetics or muscle performance in age-related skeletal muscle mitochondrial dysfunction.

Subjects were randomized 1:1 to receive either elamipretide at 0.25 mg/kg/hr intravenously at a rate of 60 mL/hr for 2 hours, or placebo (lyophilized excipients without elamipretide) intravenously at a rate of 60 mL/hr for 2 hours. Each treatment group went through three distinct periods: Screening (up to 28 days), Treatment (1day), and Observation (7 days).

Arms: arm 1: Elamipretide given as an intravenous infusion of 0.25 mg/kg/hr at a rate of 60 mL/hr for 2 hours. arm 2: Placebo (lyophilized excipients without elamipretide) given as an intravenous infusion at a rate of 60 mL/hr for 2 hours.
Interventions: intervention 1: Elamipretide intervention 2: Placebo
Intervention descriptions: intervention 1: Elamipretide 0.25 mg/kg/hour administered as an intravenous infusion at the rate of 60 mL/hour for 2 hours intervention 2: Placebo administered as intravenous infusion at a rate of 60 mL/hour for 2 hours

Protocol documents:
Clinical trial NCT01962441
Conditions: Hepatitis C
Keywords: 7977 GS-7977 PSI-7977 Sofosbuvir (SOF) Pegylated Interferon (Peg-IFN) Ribavirin (RBV)
Sponsor: Gilead Sciences
Start date: 2013-09-24; Completion date: 2016-07-07
Enrollment: 601 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV infection.

Detailed description:

Arms: arm 1: SOF+RBV for 16 weeks arm 2: SOF+RBV for 24 weeks arm 3: SOF+RBV+Peg-IFN for 12 weeks arm 4: Participants from the SOF+RBV arms (16 weeks or 24 weeks) who experienced virologic failure on treatment, or during the posttreatment period at or before Posttreatment Week 24 may be eligible to enroll into the Retreatment Substudy to receive SOF+RBV+Peg-IFN for 12 weeks.
Interventions: intervention 1: SOF intervention 2: RBV intervention 3: Peg-IFN
Intervention descriptions: intervention 1: 400 mg tablet administered orally once daily intervention 2: Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) intervention 3: 180 µg administered via subcutaneous injection once weekly

Protocol documents:
Clinical trial NCT02006472
Conditions: Huntington's Disease
Keywords: Huntington's Disease Pridopidine Pride-HD
Sponsor: Prilenia
Start date: 2014-02-28; Completion date: 2016-07-07
Enrollment: 408 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, multinational, randomized, parallel-group, double-blind, placebo-controlled, dose range finding study to compare the efficacy and safety of different doses of pridopidine versus placebo in the treatment of motor impairment in Huntington's Disease (HD).

Detailed description:
Originally, the study was designed to assess the effect of pridopidine on motor function at 26 weeks. Due to the recognition that the primary target of pridopidine is the Sigma-1 receptor, the trial was extended from 26 to 52 weeks to evaluate the effect of pridopidine on Total Functional Capacity (TFC). A minimum of 52 weeks are needed for the placebo group to decline and allow a window to assess an effect on TFC (a prespecified endpoint). Approximately 20% of patients completed 26 weeks of the study before IRB approvals for this extension, and did not continue into the 2nd treatment period up to 52 weeks.

Arms: arm 1: Twice daily arm 2: Twice daily arm 3: Twice daily arm 4: Twice daily arm 5: Twice daily
Interventions: intervention 1: Pridopidine intervention 2: Placebo
Intervention descriptions: intervention 1: 22.5 mg and 45 mg capsules intervention 2: Capsules matching drug

Protocol documents:
Clinical trial NCT00819780
Conditions: Colon Cancer Colorectal Cancer Rectal Cancer Metastatic Colorectal Cancer
Keywords: Colon Cancer Colorectal Cancer Rectal Cancer Panitumumab Vectibix modified FOLFOX 6 mFOLFOX 6 FOLFOX Bevacizumab Avastin First-Line metastatic
Sponsor: Amgen
Start date: 2009-04-24; Completion date: 2016-07-07
Enrollment: 285 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to estimate the treatment effect on progression-free survival (PFS) of panitumumab relative to bevacizumab in combination with mFOLFOX6 chemotherapy as first-line therapy in patients with tumors expressing wild-type KRAS, unresectable mCRC.

Detailed description:

Arms: arm 1: Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and modified FOLFOX6 (mFOLFOX6) chemotherapy regimen consisting of oxaliplatin (85 mg/m\^2), leucovorin (400 mg/m\^2) and 5-fluorouracil (5-FU) (2400 mg/m\^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death. arm 2: Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 regimen consisting of oxaliplatin (85 mg/m\^2), leucovorin (400 mg/m\^2), followed by 5-FU (2400 mg/m\^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Interventions: intervention 1: Panitumumab intervention 2: Bevacizumab intervention 3: mFOLFOX6
Intervention descriptions: intervention 1: Panitumumab is a fully human immunoglobulin G (IgG)2 monoclonal antibody antagonist directed against human Epidermal Growth Factor receptor (EGFr). intervention 2: Bevacizumab is a humanized monoclonal IgG1 antibody that is directed against Vascular Endothelial Growth Factor (VEGF). intervention 3: mFOLFOX6 regimen is a combination therapy of oxaliplatin (85 mg/m\^2) administered as a 2-hour infusion on Day 1; leucovorin (400 mg/m\^2) administered as a 2-hour infusion on Day 1; followed by a loading dose of 5-fluorouracil (5-FU; 400 mg/m\^2) IV bolus administered over approximately 2 to 4 minutes on Day 1, then 5- FU (2400 mg/m\^2) via ambulatory pump administered for a period of 46 to 48 hours.

Protocol documents:
Clinical trial NCT02187159
Conditions: Pain Associated With Fibromyalgia
Keywords: pain fibromyalgia
Sponsor: Daiichi Sankyo
Start date: 2014-11-01; Completion date: 2016-07-07
Enrollment: 1270 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in participants receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the participant that best describes his or her worst pain over the previous 24 hours.

Detailed description:

Arms: arm 1: Participants take one each of placebo tablet and capsule in the morning, and one DS-5565 tablet once daily (QD) with a placebo capsule in the evening arm 2: Participants take one DS-5565 tablet and one placebo capsule, twice daily (BID) arm 3: Participants take one pregabalin capsule and one placebo tablet BID arm 4: Participants take one each of placebo tablet and capsule BID
Interventions: intervention 1: DS-5565 intervention 2: Pregabalin intervention 3: Placebo tablet intervention 4: Placebo capsule
Intervention descriptions: intervention 1: DS-5565 15 mg tablet for oral administration intervention 2: Pregabalin 150 mg capsule for oral administration intervention 3: Placebo tablet (matching DS5565) for oral administration intervention 4: Placebo capsule (matching pregabalin) for oral administration

Protocol documents:
Clinical trial NCT02203565
Conditions: Breast Cancer Skin Reactions Secondary to Radiation Therapy
Sponsor: Stanford University
Start date: 2014-07-01; Completion date: 2016-07-07
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot clinical trial studies Dakin's solution in preventing radiation dermatitis in patients with breast cancer undergoing radiation therapy. Radiation dermatitis is a skin condition in which the affected skin becomes painful, red, itchy, and blistered. Dakin's solution may help reduce dermatitis caused by radiation therapy.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the percent change in women who experience grade 3 or 4 radiation dermatitis as defined by the Stanford Radiation Dermatitis Scoring System during radiation treatment for breast cancer compared to historical experience using standard skin care.

SECONDARY OBJECTIVES:

I. To assess the feasibility of daily application of the hypochlorite solution (Dakin's solution), and to assess levels of pain during radiotherapy treatment.

OUTLINE:

Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.

After completion of study treatment, patients are followed up at 4-6 weeks.

Arms: arm 1: Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.
Interventions: intervention 1: Dakin's solution intervention 2: radiation therapy intervention 3: questionnaire administration intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: Applied topically intervention 2: Undergo radiation therapy intervention 3: Ancillary studies intervention 4: Optional correlative studies

Protocol documents:
Clinical trial NCT02025426
Conditions: Pre-eclampsia
Keywords: Cesarean delivery Spinal Anesthesia
Sponsor: Duke University
Start date: 2012-09-01; Completion date: 2016-07-08
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phenylephrine administration is associated with reductions in CO and SctO2 compared with ephedrine when used for blood pressure management in women with pre-eclampsia undergoing cesarean delivery under spinal anesthesia.

Detailed description:

Arms: arm 1: Phenylephrine for maintaining blood pressure within 10 % of baseline arm 2: Ephedrine for maintaining blood pressure within 10 % of baseline
Interventions: intervention 1: Phenylephrine intervention 2: Ephedrine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: