ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01661179
Conditions: Unresectable Locally Advanced or Metastatic, Medullary Thyroid Carcinoma
Keywords: Medullary Thyroid Carcinoma Medullary Thyroid Cancer Vandetanib
Sponsor: Genzyme, a Sanofi Company
Start date: 2012-11-01; Completion date: 2014-07-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Open-label Study to Evaluate the Safety and Tolerability of Vandetanib 300 mg/day in Japanese Patients with Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma.

Detailed description:
A Phase I/II, Open-label Study to Evaluate the Safety and Tolerability of Vandetanib 300 mg/day in Japanese Patients with Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma

Arms: arm 1: 300 mg/day vandetanib
Interventions: intervention 1: Vandetanib 300mg
Intervention descriptions: intervention 1: 300 mg oral dose once daily (100 mg x 3 tablets)

Protocol documents:
Clinical trial NCT01709162
Conditions: Melanoma
Sponsor: Bristol-Myers Squibb
Start date: 2013-03-01; Completion date: 2014-07-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether additional doses of ipilimumab have a positive effect on survival in the treatment of advanced melanoma that has progressed after successful initial treatment with ipilimumab.

Detailed description:

Arms: arm 1: Participants received ipilimumab, 3 mg/kg, by intravenous infusion, every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent arm 2: Participants received the investigator's choice of chemotherapy, administered per package instructions.
Interventions: intervention 1: Ipilimumab intervention 2: Chemotherapy
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01709474
Conditions: Systemic Lupus Erythematosus
Keywords: SLE Vitamin D3 Vitamin D deficiency IFN alpha expression
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Start date: 2013-06-01; Completion date: 2014-07-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the effects of 18 weeks of high-dose vitamin D3 supplementation compared with standard-dose vitamin D3 supplementation on immune function, glucose homeostasis, and bone metabolism in children with systemic lupus erythematosus (SLE) and serum 25-hydroxyvitamin D \[25(OH)D\] levels ≤20 ng/mL.

Detailed description:
This is a multi-center, phase II, 18-week, two arm, unblinded randomized clinical trial.

Seventy-eight pediatric subjects with SLE and 25(OH)D levels ≤ 20 ng/mL will be randomized in a 1:1 ratio to receive either standard-dose (400 IU/day) or high-dose (6,000 IU/day) vitamin D3 for 18 weeks based upon weight at baseline. Subjects randomized to the high-dose vitamin D3 treatment arm will receive 6,000 IU per day from baseline until the subject's vitamin D levels reach ≥ 40 ng/mL at which point the vitamin D3 dose will be reduced to 4,000 IU per day. Subjects randomized to the high-dose treatment arm weighing \< 40 kg will receive supplementation five days per week and all other subjects will receive supplementation seven days a week.

In addition to the baseline, and weeks 6, 12, and 18 visits, subjects randomized to the high-dose treatment arm will return at Weeks 3 and 9 to assess for symptoms of vitamin D toxicity. If a subject in the high-dose arm is found to exhibit evidence of vitamin D toxicity at the week 12 visit, he/she will be asked to return to their clinical research site for an additional vitamin D toxicity assessment at week 15. Study personnel will record each subject's interval history, assess adverse events, disease activity, and collect samples for safety and mechanistic assessments.

Arms: arm 1: 6000 IU of vitamin D3 by mouth daily until the subject's serum 25(OH) level is ≥ 40ng/mL at which point the supplementation dose is reduced to 4,000 IU/day. Note: Subjects weighing \<40 kilograms (kg) at study entry will receive their dose five days a week and all other subjects seven days a week. arm 2: 400 IU/day of vitamin D3 by mouth daily.
Interventions: intervention 1: Vitamin D3 6000 IU intervention 2: Vitamin D3 400 IU
Intervention descriptions: intervention 1: Subjects will receive 6,000 IU of vitamin D3 by mouth daily until the subject's serum 25(OH) level is ≥ 40ng/mL at which point the supplementation dose will be reduced to 4,000 IU/day. Note: Subjects weighing \<40 kilograms (kg) at study entry will receive their dose five days a week and all other subjects seven days a week. intervention 2: Subjects will receive 400 IU/day of vitamin D3 daily by mouth.

Protocol documents:
Clinical trial NCT01722097
Conditions: Neuromuscular Blockade Pain Laparoscopy
Sponsor: Herlev Hospital
Start date: 2012-11-01; Completion date: 2014-07-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study on laparoscopic hysterectomy is to investigate postoperative pain. Patients are allocated to either deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) or moderate neuromuscular blockade and usual intra-abdominal pressure (12 mmHg).

Primary hypothesis:

Deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) reduces postoperative pain compared to moderate neuromuscular blockade and intra-abdominal pressure (12 mmHg).

Detailed description:

Arms: arm 1: Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron arm 2: Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron
Interventions: intervention 1: Rocuronium intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01723397
Conditions: Allergic Rhinitis
Sponsor: University of Chicago
Start date: 2012-11-01; Completion date: 2014-07-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objectives of this protocol are:

1. to confirm the inhibitory effect of Nasaleze on the immediate response to nasal challenge with antigen, and
2. to show that inhibition of the immediate response to nasal challenge with antigen by Nasaleze inhibits subsequent inflammatory events.

Detailed description:

Arms: arm 1: Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge arm 2: Placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge
Interventions: intervention 1: Nasaleze Spray intervention 2: Placebo spray intervention 3: Allergen
Intervention descriptions: intervention 1: Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen intervention 2: Subjects are treated with placebo nasal spray then challenged with allergen intervention 3: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo

Protocol documents:
Clinical trial NCT01748045
Conditions: Bronchopulmonary Dysplasia
Keywords: Inhaled Nitric Oxide Bronchopulmonary Dysplasia Late Prematurity Chronic Respiratory Morbidity
Sponsor: Tufts Medical Center
Start date: 2013-03-01; Completion date: 2014-07-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to determine if inhaled nitric oxide will improve short and long term respiratory outcomes in preterm infants. Infants born at a gestational age of 30-36 weeks and who require breathing support with high flow nasal cannula, nasal continuous positive airway pressure, or nasal intermittent positive pressure will be randomized to receive either inhaled nitric oxide or placebo. The dose will then be decreased per protocol until all respiratory support has been discontinued. Infants will be followed to evaluate safety and efficacy of non-invasive iNO delivery, up to 12 months corrected gestational age.

Detailed description:

Arms: arm 1: iNO to start at 20 parts per million (ppm) for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued. arm 2: Placebo gas will be adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Interventions: intervention 1: inhaled nitric oxide intervention 2: Placebo Comparator - nitrogen gas
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01765465
Conditions: Postcholecystectomy Syndrome
Keywords: postcholecystectomy syndrome laparoscopic cholecystectomy Rowachol
Sponsor: DongGuk University
Start date: 2013-01-01; Completion date: 2014-07-01
Enrollment: 138 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Postcholecystectomy syndrome (PCS) includes a heterogeneous group of diseases, usually manifested by the presence of abdominal symptoms following gallbladder removal. The pathogenesis of PCS has not been identified; therefore there is no consensus of medical treatment on PCS. The Action of Rowachol are to inhibit hepatic 3-hydroxy-3-methylglutaric acid(HMG)-coenzyme A(CoA) reductase, to inhibits cholesterol nucleation in bile from patients with cholesterol gallstones, and to promote biliary lipid secretion.

The purpose of this study is to determine whether Rowachol is useful in the prevention of PCS and symptoms change after laparoscopic cholecystectomy

Detailed description:

Arms: arm 1: Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months arm 2: Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months
Interventions: intervention 1: Rowachol intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01769443
Conditions: Primary Heart Transplant Heart Transplantation Heart Transplant
Keywords: desensitization therapy bortezomib (VELCADE®) plasmapheresis
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Start date: 2013-06-01; Completion date: 2014-07-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to evaluate the efficacy of desensitization therapy, which includes VELCADE® (bortezomib) and plasmapheresis, on select sensitized patients awaiting heart transplantation.

Detailed description:
Bortezomib works by decreasing plasma cells in the blood. Plasma cells produce antibodies. Plasmapheresis is a procedure that removes antibodies from the blood. Plasma cells and antibodies produced by plasma cells can be involved in organ rejection after transplantation.

This trial will evaluate if decreasing plasma cells and antibodies with bortezomib and plasmapheresis can reduce complications while participants are waiting for their heart transplant. The evaluation of efficacy is defined by a lower complication rate while on the heart transplant waitlist.

Arms: arm 1: Subject(s) randomized to no desensitization therapy pre-transplant. arm 2: Subject(s) randomized to desensitization therapy pre-transplant.

Desensitization therapy regimen pre-transplant: Plasmapheresis for 3 consecutive days (treatment days 0, 1 and 2) followed by concomitant bortezomib dosed at 1.3 mg/m\^2 as a 3 to 5 second bolus intravenous injection on treatment days 0, 3, 7 and 10. The first dose of bortezomib is administered between 4-8 hours after the first plasmapheresis session is completed and there must be at least 96 hours between the second and third dose of bortezomib.
Interventions: intervention 1: bortezomib intervention 2: plasmapheresis
Intervention descriptions: intervention 1: Bortezomib dosed at 1.3 mg/m\^2 as a 3 to 5 second bolus administered by intravenous injection on treatment days 0, 3, 7 and 10. The first dose of bortezomib is administered between 4-8 hours after the first plasmapheresis session is completed and there must be at least 96 hours between the second and third dose of bortezomib. intervention 2: Plasmapheresis for 3 consecutive days (treatment days 0, 1 and 2) followed by concomitant bortezomib dosed at 1.3 mg/m\^2 as a 3 to 5 second bolus administered by intravenous injection on treatment days 0, 3, 7 and 10. The first dose of bortezomib is administered between 4-8 hours after the first plasmapheresis session is completed and there must be at least 96 hours between the second and third dose of bortezomib.

Protocol documents:
Clinical trial NCT01780636
Conditions: Non-relaxing Puborectalis Syndrome
Keywords: Non relaxing puborectalis syndrome Botulinum toxin A Botox Constipation
Sponsor: Karen Noblett
Start date: 2013-01-01; Completion date: 2014-07-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Our study aims to determine the efficacy of ultrasound and EMG guided Botox injections into the puborectalis muscle in women with non-relaxing puborectalis syndrome. With use of this technique, we believe we will find that Botox injections decrease symptom severity and improve quality of life (QOL) in patients with NRPS. All enrolled patients will receive ultrasound and EMG guided Botox injections at three points along the puborectalis muscle. Post-injection data will be obtained with a defecation diary and questionnaire data at the 2-week, 3-month, and 6-month intervals.

Detailed description:
Non-relaxing puborectalis syndrome (NRPS) is an obstructive defecatory disorder that presents with chronic constipation, anismus, or a sensation of incomplete rectal emptying. The specific etiology of this syndrome is unknown. The true incidence of NRPS is unknown, but it is estimated that 4% of patients with defecatory disorders have NRPS. Previous therapies for non-relaxing PRS have included biofeedback, pelvic floor physical therapy, dietary changes, laxatives, enemas, and surgical division of the puborectalis muscle. Unfortunately, responses to these treatments have been variable at best. Direct injection of botulinum toxin (Botox) into the puborectalis muscle is an alternative approach for treating NRPS and has recently been reported in a limited number of studies. Botox blocks cholinergic nerve endings in the autonomic nervous system and has been used to weaken the puborectalis muscle in constipated patients.

Our study aims to determine the efficacy of ultrasound and EMG guided Botox injections into the puborectalis muscle in women with NRPS. With use of this technique, we believe we will find that Botox injections decrease symptom severity and improve quality of life (QOL) in patients with NRPS.

We plan to compare patient reported symptoms, symptom severity, and QOL prior to Botox injections with symptoms and QOL at 2-week, 3-month, and 6-month intervals after Botox injection into the puborectalis muscle in patients with NRPS.

All enrolled patients will receive ultrasound and EMG guided Botox injections at three points along the puborectalis muscle. Post-injection data will be obtained with a defecation diary and questionnaire data at the 2-week, 3-month, and 6-month intervals. Additional injections will be offered to patients who fail the initial treatment.

Arms: arm 1: All patients will be given the active Botox injection and thus this study will remain open-label and non-randomized as this is a pilot study to determine initial efficacy.
Interventions: intervention 1: botulinum toxin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01783678
Conditions: Chronic Hepatitis C Human Immunodeficiency Virus
Sponsor: Gilead Sciences
Start date: 2013-01-01; Completion date: 2014-07-01
Enrollment: 275 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.

Detailed description:

Arms: arm 1: Treatment-naive (TN) participants with HIV-1 and genotype 2 HCV coinfection will receive sofosbuvir plus RBV for 12 weeks. arm 2: Treatment-experienced (TE) participants with HIV-1 and genotype 2 or 3 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks. arm 3: Treatment naive (TN) participants with HIV-1 and genotype 1, 3, or 4 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks.
Interventions: intervention 1: Sofosbuvir intervention 2: RBV
Intervention descriptions: intervention 1: Sofosbuvir 400 mg tablet administered orally once daily intervention 2: Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents:
Clinical trial NCT01827306
Conditions: Shoulder Pain
Sponsor: Sport and Spine Rehab Clinical Research Foundation
Start date: 2013-03-01; Completion date: 2014-07-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Biofreeze® is a topical analgesic, frequently used in the office or given to a patient for home use as a way to mitigate pain during the course of treatment. Rehabilitative exercises are considered an important component of care for shoulder pain patients, although pain can be a limiting factor in the advancement of rehabilitation. The purpose of this study is to evaluate the addition of Biofreeze® to an in-office group of shoulder pain patients to determine its impact on pain reduction. Methods: Patients 18-64 years old with mechanical shoulder pain who are candidates for standard shoulder therapy will be randomized into two groups (N=20). The Control group (N=10) will receive standard shoulder therapy alone while the Intervention group (N=10) will receive standard shoulder therapy plus Biofreeze® just prior to initiating the in-office exercise program. Values of pain (NPRS) and disability (ASES) will be recorded at baseline, 2 weeks, and 4 weeks. Hypotheses will be addressed by repeated measures ANOVAs within and between group, time, and interaction main effects. Clinical Relevance: Progression of therapeutic exercises can be limited by pain and the associated disability. The ability to decrease shoulder pain and disability with a topical analgesic will allow health care professionals to advance patients through a therapeutic exercise program without the restriction of pain. In turn, patients will correct the underlying condition of their shoulder pain at a faster rate.

Detailed description:

Arms: arm 1: Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program. arm 2: Subjects in this arm will complete a standard shoulder therapy program as normal, with no intervention.
Interventions: intervention 1: Biofreeze
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01835548
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Sponsor: Neos Therapeutics, Inc
Start date: 2013-07-01; Completion date: 2014-07-01
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled, parallel group, Phase 3 trial to evaluate the safety and efficacy of NT0102 in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age in a laboratory classroom study.

Detailed description:

Arms: arm 1: After the screening/washout period, all participants will receive study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug will be selected, and participants will stay on that dose for 1 week (dose stabilization period). At the end of this period, participants will be randomized to a treatment. Participants in this arm will be given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period. arm 2: After the screening/washout period, all participants will receive study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug will be selected, and participants will stay on that dose for 1 week (dose stabilization period). At the end of this period, participants will be randomized to a treatment. Participants in this arm will be given placebo as matching ODT once daily for one week during the double-blind treatment period.
Interventions: intervention 1: NT0102 intervention 2: Placebo
Intervention descriptions: intervention 1: NT0102 (methylphenidate polistirex \[MPP\] extended release \[XR\] ODT) was given once daily at a dose equivalent to 20-60 mg methylphenidate hydrochloride. intervention 2: Matching ODT placebo was given once daily.

Protocol documents:
Clinical trial NCT01844895
Conditions: Rheumatoid Arthritis
Sponsor: Bristol-Myers Squibb
Start date: 2013-04-01; Completion date: 2014-07-01
Enrollment: 120 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to implement a substudy in approximately 120 rheumatoid arthritis (RA) subjects to compare the steady-state serum trough concentration (Cminss), Cmax and area under the curve (AUC) during the dosing interval (TAU) of subcutaneous (SC) Abatacept injection of 125 mg via the autoinjector and via the BD Hypak™ Physiolis prefilled syringe.

Detailed description:
Study Classification:

* Safety: show if the drug is safe under conditions of proposed use
* Efficacy: measure of an intervention's influence on a disease or health condition
* Safety/Efficacy
* Pharmacokinetics: the action of a drug in the body over a period of time including the process of absorption, distribution and localization in tissue, biotransformation, and excretion of the compound.

Arms: arm 1: Abatacept (prefilled syringe) 125 mg/device solution subcutaneously weekly for 3 months

Abatacept (autoinjector) 125 mg/device solution subcutaneously weekly for 1 month
Interventions: intervention 1: Abatacept
Intervention descriptions: intervention 1: None

Protocol documents: