ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02453555
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2015-05-14; Completion date: 2017-03-27
Enrollment: 275 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will compare the use of fixed dose combination of empagliflozin and linagliptin to linagliptin alone in patient with type 2 diabetes mellitus

Detailed description:

Arms: arm 1: patient to receive 5 mg linagliptin once daily arm 2: patient to receive one tablet once daily arm 3: patient to receive one tablet once daily arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: Linagliptin intervention 2: Empagliflozin placebo + linagliptin placebo low dose intervention 3: Empagliflozin + linagliptin low dose intervention 4: Linagliptin placebo intervention 5: Empagliflozin + linagliptin high dose intervention 6: Empa + lina highdose placebo
Intervention descriptions: intervention 1: None intervention 2: Matching placebo empagliflozin + linagliptin intervention 3: tablet intervention 4: Matching placebo linagliptin intervention 5: tablet intervention 6: None

Protocol documents:
Clinical trial NCT02937766
Conditions: Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) in Healthy Post-menopausal Women
Sponsor: AMAG Pharmaceuticals, Inc.
Start date: 2016-10-07; Completion date: 2017-03-27
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate that Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) delivered subcutaneously via auto-injector is associated with less pain as compared to intramuscular injections of Makena®

Detailed description:

Arms: arm 1: Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections) arm 2: Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections)
Interventions: intervention 1: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) intervention 2: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02211209
Conditions: Familial Chylomicronemia Syndrome
Sponsor: Ionis Pharmaceuticals, Inc.
Start date: 2014-12-01; Completion date: 2017-03-28
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in participants with Familial Chylomicronemia Syndrome

Detailed description:

Arms: arm 1: Volanesorsen-matching placebo administered subcutaneously once-weekly for 52 weeks. arm 2: Volanesorsen 300 mg administered subcutaneously once-weekly for 52 weeks.
Interventions: intervention 1: Volanesorsen intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01748942
Conditions: Dysphagia Pain Stage I Oropharyngeal Squamous Cell Carcinoma Stage II Oropharyngeal Squamous Cell Carcinoma Stage III Oropharyngeal Squamous Cell Carcinoma
Sponsor: OHSU Knight Cancer Institute
Start date: 2012-12-01; Completion date: 2017-03-29
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized pilot clinical trial studies dexamethasone in reducing oral pain and dry mouth after surgery in patients with oropharyngeal cancer. Dexamethasone may help lower pain and dry mouth caused by surgery.

Detailed description:
PRIMARY OBJECTIVES:

I. To prospectively determine if a longer 4-day course of dexamethasone (or equivalent) for the management of postoperative pain and dysphagia following transoral robotic surgery (TORS) is superior to the current standard of a single injection of dexamethasone 10 mg.

SECONDARY OBJECTIVES:

I. Determine the effect of postoperative corticosteroids on postoperative dysphagia following TORS.

II. Determine the effect of postoperative corticosteroids on length of hospital stay following TORS.

III. Determine the complications associated with postoperative corticosteroid use after TORS.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive dexamethasone intravenously (IV) at the time of surgery and orally (PO) every 8 hours for up to 4 days following surgery.

ARM II: Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.

After completion of study treatment, patients are followed up for up to 12 months.

Arms: arm 1: Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery. arm 2: Patients receive dexamethasone IV at the time of surgery and placebo PO every 8 hours for up to 4 days following surgery.
Interventions: intervention 1: Dexamethasone intervention 2: Dexamethasone intervention 3: Placebo intervention 4: Quality-of-Life Assessment intervention 5: Questionnaire Administration intervention 6: Transoral Robotic Surgery
Intervention descriptions: intervention 1: Given IV intervention 2: Given PO intervention 3: Given PO intervention 4: Ancillary studies intervention 5: Ancillary studies intervention 6: Undergo TORS

Protocol documents:
Clinical trial NCT00079417
Conditions: Intraocular Retinoblastoma
Sponsor: Children's Oncology Group
Start date: 2005-12-26; Completion date: 2017-03-31
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase III trial is studying how well giving carboplatin and vincristine together with standard local ophthalmic therapy works in treating children with intraocular retinoblastoma. Drugs used in chemotherapy, such as carboplatin and vincristine, work in different ways to stop tumor from dividing so they stop growing or die. It is not yet known whether neoadjuvant chemotherapy combined with standard local ophthalmic therapy is effective in treating intraocular retinoblastoma.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the 2-year event-free survival of patients with Group B intraocular retinoblastoma treated with neoadjuvant chemoreduction comprising carboplatin and vincristine and standardized local ophthalmic therapy.

SECONDARY OBJECTIVES:

I. Determine the response rate after one course of chemoreduction (before standardized local ophthalmic therapy) in these patients.

II. Correlate response rate with event-free survival in patients treated with this regimen.

III. Determine the incidence of toxic effects in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive chemoreduction comprising carboplatin IV over 60 minutes followed by vincristine IV over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local laser therapy, cryotherapy, and/or radioactive plaque comprising iodine I 125 or ruthenium Ru 106.

Patients are followed every 3-4 weeks until there is no active tumor seen on a minimum of 3 ophthalmic exams under anesthesia, every 6-8 weeks until 3 years of age, every 4-6 months until 10 years of age, and then annually thereafter.

Arms: arm 1: Patients receive chemoreduction comprising carboplatin IV over 60 minutes followed by vincristine IV over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local laser therapy, cryotherapy, and/or radioactive plaque comprising iodine I 125 or ruthenium Ru 106.
Interventions: intervention 1: Carboplatin intervention 2: Cryosurgery intervention 3: Infrared Laser Therapy intervention 4: Iodine I-125 intervention 5: Radiation Therapy intervention 6: Ruthenium Ru-106 intervention 7: Vincristine Sulfate
Intervention descriptions: intervention 1: Given IV intervention 2: None intervention 3: None intervention 4: Undergo radioactive therapy intervention 5: Undergo radioactive therapy intervention 6: Undergo radioactive therapy intervention 7: Given IV

Protocol documents:
Clinical trial NCT01818739
Conditions: Endometrial Cancer
Keywords: Endometrial Cancer Robotic-Assisted Staging
Sponsor: Ohio State University Comprehensive Cancer Center
Start date: 2013-03-01; Completion date: 2017-03-31
Enrollment: 204 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial studies lymph node mapping in patients with endometrial cancer. Lymph node mapping may allow for limited removal of lymph nodes in as part of endometrial cancer staging and treatment.

Detailed description:
PRIMARY OBJECTIVE:

I. To estimate the negative predictive value of pelvic sentinel lymph node (SLN) in endometrial cancer to predict nodal metastasis.

SECONDARY OBJECTIVE:

II. To examine the ability of sentinel lymph nodes to increase the detection of metastatic disease through ultra-sectioning and immuno-histochemical (IHC) staining by comparing IHC results and standard hematoxylin and eosin (H\&E) results.

OUTLINE:

Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy and detection of sentinel lymph nodes is noted in the within 30 minutes of injection of the dye, followed by full pelvic lymph node dissection and aortic lymph node dissection as indicated, and standard hysterectomy and salpingo-oophorectomy.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years for a total of 5 years according to the standard surveillance guidelines for endometrial cancer.

Arms: arm 1: Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.
Interventions: intervention 1: sentinel lymph node detection intervention 2: indocyanine green solution intervention 3: isosulfan blue intervention 4: sentinel lymph node biopsy
Intervention descriptions: intervention 1: Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue intervention 2: Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue intervention 3: Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue intervention 4: Undergo sentinel lymph node biopsy

Protocol documents:
Clinical trial NCT01864525
Conditions: Essential Voice Tremor Vocal Tremor Voice Tremor Essential Tremor of Voice
Keywords: voice tremor essential tremor essential voice tremor voice treatment octanoic acid octanol voice disorder dysphonia
Sponsor: Syracuse University
Start date: 2013-07-01; Completion date: 2017-03-31
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Essential voice tremor is a neurological condition that produces a regular, shaking quality in the voice. One form of drug treatment that produces some improvement in tremor of the hands is octanoic acid, which is a food additive that is similar to alcohol. Research suggests that octanoic acid may reduce tremor in the hands/arms with few side effects and no intoxication effects. This study will determine whether octanoic acid may be useful for reducing tremor when it affects the voice. Researchers are hypothesizing that octanoic acid will reduce the effects of tremor on the voice.

Detailed description:
Background:

* Essential tremor of the voice produces regular shaking and hoarseness in the voice, making it difficult speech difficult to understand
* Several previous studies have found that octanoic acid and octanol, which are related to alcohol, can improve tremor in some people without producing many side effects and without producing intoxication
* Researchers are interested in determining whether octanoic acid can improve tremor that affects the voice

Objectives:

* To determine the effects of octanoic voice using voice recordings and listener ratings of voice
* To determine the effects of octanoic acid on level of voice disability experienced by people with essential voice tremor

Arms: arm 1: Participants will receive a pill/capsule with an inactive ingredient during the placebo arm of this study. arm 2: Participants will receive a pill/capsule with octanoic acid (amount determined by the participant's weight) during the experimental arm of this study.
Interventions: intervention 1: Octanoic acid intervention 2: Inactive capsule
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02755649
Conditions: Atopic Dermatitis
Sponsor: Regeneron Pharmaceuticals
Start date: 2016-01-31; Completion date: 2017-03-31
Enrollment: 325 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of the trial is to evaluate the efficacy of 2 dose regimens of dupilumab compared to placebo, administered with concomitant topical corticosteroids (TCS), in adult patients with severe AD who are not adequately controlled with, or are intolerant to, oral Cyclosporine A (CSA), or when this treatment is currently not medically advisable.

The secondary objective is to assess the safety and tolerability of 2 dose regimens of dupilumab compared to placebo, administered with concomitant TCS, in adult patients with severe AD who are not adequately controlled with, or are intolerant to, oral CSA, or when this treatment is currently not medically advisable.

Detailed description:

Arms: arm 1: Participants received one subcutaneous (SC) injection of dupilumab matching placebo once per week (QW) (following two SC injections on day 1) from Week 1 to Week 15. All participants were required to undergo treatment with topical corticosteroids (TCS) using a standardized regimen that continued through the end of the treatment period (Week 16). Starting at week 16, participants could roll over into an open-label extension (OLE) study (R668-AD-1225), if they were considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (\[Week 28, end of study (EOS) period\]). arm 2: Participants received one subcutaneous (SC) injection of dupilumab 300 mg every 2 weeks (Q2W) from Week 1 to Week 15 (following a SC loading dose of 600 mg on day 1). During weeks in which dupilumab was not administered, participants received matching placebo. All participants were required to undergo treatment with topical corticosteroids (TCS) using a standardized regimen that continued through the end of the treatment period (Week 16). Starting at week 16, participants could roll over into an open-label extension (OLE) study (R668-AD-1225), if they were considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (\[Week 28, end of study (EOS) period\]). arm 3: Participants received one subcutaneous (SC) injection of dupilumab 300 mg once per week (QW) (following an SC loading dose of 600 mg on day 1) from Week 1 to Week 15. All participants were required to undergo treatment with topical corticosteroids (TCS) using a standardized regimen that continued through the end of the treatment period (Week 16). Starting at week 16, participants could roll over into an open-label extension (OLE) study (R668-AD-1225), if they were considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (\[Week 28, end of study (EOS) period\]).
Interventions: intervention 1: Dupilumab intervention 2: Matching Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00669162
Conditions: Prostate Cancer
Sponsor: University of Kansas Medical Center
Start date: 2012-08-01; Completion date: 2017-04-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Following a radical prostatectomy and lymph node sampling, eligible patients will undergo post-operative radiation therapy, concurrent weekly docetaxel chemotherapy , and hormonal therapy (Casodex daily and Zoladex every 3 months for 2 times or Lupron 22.5 mg im every 3 months for 2 times).

Detailed description:
After consent, laboratory and radiologic tests will be done and a baseline questionnaire will be completed. Participants will then be started on the protocol specific hormonal therapy for a total of 6 months. After 2 months of hormone therapy the participants will begin radiation therapy and concurrent docetaxel chemotherapy treatments.

The radiation therapy will be delivered to a total dose of 66.0 Gy at 2.0 Gy/fraction (fx) once daily over 7 weeks, using either a 3-D conformal technique and/or intensity modulated radiation therapy (IMRT).

Participants will receive docetaxel once a week for a total of 7 infusions with concurrent radiation therapy treatments. The weekly dose of docetaxel will be 20 mg/m2. Docetaxel will be given as an intravenous (IV) infusion over 30 minutes within ≤6 hours prior to the radiotherapy treatments.

Arms: arm 1: Radiation Therapy (RT) to 66 Gy in 33 treatment fractions at 2.0 Gy/fx Concurrent Docetaxel (with RT) at 20 mg/m2 weekly x 7 Casodex (50 mg po daily)x 6 months Zoladex (10.8 mg sc q 3 mos x 2) or Lupron (22.5 mg im q 3 mos x 2)
Interventions: intervention 1: Docetaxel intervention 2: Radiation Therapy intervention 3: Casodex and Zoladex (or Lupron)
Intervention descriptions: intervention 1: 20mg/m2 IV weekly for 7 weeks intervention 2: 66.0 Gy delivered in 33 daily fractions at 2.0 Gy/fx intervention 3: Casodex 50 mg po daily for 6 months, and Zoladex 10.8 mg sc q 3 mos x 2 (or Lupron 22.5 mg im q 3 mos x 2)

Protocol documents:
Clinical trial NCT00823797
Conditions: Adult Anaplastic Astrocytoma Adult Anaplastic Oligodendroglioma Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Neoplasm
Sponsor: University of Washington
Start date: 2008-10-01; Completion date: 2017-04-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well bendamustine hydrochloride works in treating patients with anaplastic glioma or glioblastoma that has come back (recurrent) or growing, spreading or getting worse (progressive). Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description:
PRIMARY OBJECTIVES:

I. The primary endpoint for this study is the 6-month progression-free survival-i.e., the proportion of patients who remain alive and free of any tumor progression at 6 months.

SECONDARY OBJECTIVES:

I. To determine the safety of single agent bendamustine (Treanda) (bendamustine hydrochloride) the treatment of malignant gliomas.

II. To determine the efficacy of bendamustine (Treanda) as a single agent as assessed by progression-free survival (PFS) at 6 months.

III. To assess quality of life using the Functional Assessment of Cancer Therapy-Brain (FACT-BR).

OUTLINE:

Patients receive bendamustine hydrochloride intravenously (IV) over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 2 months for up to 3 years.

Arms: arm 1: Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Bendamustine Hydrochloride intervention 2: Quality-of-Life Assessment
Intervention descriptions: intervention 1: Given IV intervention 2: Ancillary studies

Protocol documents:
Clinical trial NCT01033422
Conditions: Ocular Hypertension Glaucoma
Keywords: Glaucoma Ocular hypertension Intraocular hypertension
Sponsor: Can-Fite BioPharma
Start date: 2010-10-01; Completion date: 2017-04-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the hypothesis that CF101, administered orally, will reduce intraocular pressure in patients with ocular hypertension and/or glaucoma. Eligible patients with elevated intraocular pressure will be evaluated and treated by ophthalmologist investigators, and will receive either CF101 pills or placebo (dummy) pills twice daily for 16 weeks. Ocular pressure, visual fields, and other aspects of safety and effectiveness will be monitored on a regular basis.

Detailed description:
This is a Phase 2, randomized, double-masked, placebo-controlled, parallel-group study in adult males and females, aged 18 years and over, with a diagnosis of glaucoma or ocular hypertension.

This trial will be performed in 2 segments. In Segment 1, subjects will be randomized to receive either CF101 1.0 mg, or matching placebo, given orally every 12 hours for 16 weeks. Segment 1 will enroll approximately 44 subjects, randomized in a 3:1 ratio to CF101 1.0 mg or to placebo. At the conclusion of Segment 1, a Data Review Committee (DRC) will review safety and efficacy data and advise on progression of the trial to Segment 2. Segment 2 will enroll up to approximately 44 subjects randomized in a 3:1 ratio to CF101 2.0 mg 3:1 ratio to receive with CF101 2.0 mg, or matching placebo, given orally every 12 hours for 16 weeks.

At a Screening Visit (Visit 1, performed within 4 weeks prior to Baseline), subjects who provide written informed consent will have screening procedures performed, including complete medical, ophthalmologic, and medication histories; physical examination; vital signs and weight; electrocardiogram (ECG); ophthalmologic examination; tonometry; visual field (VF) assessment; corneal pachymetry; evaluation of inclusion and exclusion criteria; safety laboratory tests; serum pregnancy test for all females of child-bearing potential; and collection of concomitant medication information.

Subjects who successfully qualify will be randomized at Baseline (Visit 2) to their assigned medication (CF101 or matching placebo) to be taken orally every 12 hours for 16 weeks. Subjects will return for assessments and a new supply of study medication at Weeks 2, 4, 8, 12, and for final assessment and discharge at Week 16. A safety telephone call will be made at Week 18.

Arms: arm 1: CF101 1mg orally q12 hours arm 2: matching placebo orally q12 hours arm 3: CF101 2mg orally q12 hours
Interventions: intervention 1: CF101 intervention 2: Placebo for
Intervention descriptions: intervention 1: CF101 1 or 2 mg tablets orally every 12 hours for 16 weeks intervention 2: Matching placebo tablets orally every 12 hours for 16 weeks

Protocol documents: