ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02032875
Conditions: Hepatitis C
Sponsor: Bristol-Myers Squibb
Start date: 2014-03-01; Completion date: 2016-01-01
Enrollment: 116 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial was open to participants who had received a liver transplant or had cirrhosis due to chronic HCV. All subjects were treated with daclatasvir+sofosbuvir+ribavirin and were followed for 24 weeks post treatment. Under certain conditions, the treatment duration could have been extended for cirrhotic participants. The study tested the efficacy and safety of this combination for treatment of HCV in cirrhotic and post transplant patients.

Detailed description:

Arms: arm 1: Participants with liver transplant received daclatasvir 60 mg, sofosbuvir 400 mg, and ribavirin (based on baseline hemoglobin and creatinine clearance and tolerated dose) tablets daily for 12 weeks and were followed for 24 weeks post treatment. arm 2: Cirrhotic participants received daclatasvir 60 mg, sofosbuvir 400 mg, and ribavirin (based on baseline hemoglobin and creatinine clearance and tolerated dose) tablets orally for 12 weeks and were followed for 24 weeks post-treatment. Cirrhotic participants who received a liver transplant while on study treatment were eligible (\>3 months post transplant) for a treatment extension of daclatasvir 60 mg, sofosbuvir 400 mg, and ribavirin (dose based on hemoglobin level) tablets orally for an additional 12 weeks
Interventions: intervention 1: Daclatasvir intervention 2: Sofosbuvir intervention 3: Ribavirin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02044302
Conditions: Post-operative Pain
Keywords: pain breast cancer breast implant breast reconstruction
Sponsor: Yale University
Start date: 2014-04-01; Completion date: 2016-01-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesize that in mastectomy patients with breast reconstruction, the addition of bupivacaine and botulinum toxin (BT) will result in better pain control in the acute and chronic setting, compared to traditional pain management techniques which rely almost exclusively on opioid analgesics and sedatives like diazepam (valium). This expectation is based on the fact that bupivacaine produces pre-emptive analgesia and BT will produce muscle relaxation, the combination of which will target different sites of pain generation, thus producing better analgesia. We also hypothesize that additional benefits may accrue from this regimen including decreased nausea and vomiting, sedation and constipation as a result of diminished opioid use1.

Detailed description:

Arms: arm 1: Current standard post-operative care for expander-implant breast reconstruction surgery consists of conventional pain medications including narcotics (like morphine, etc.) and sedatives (like valium). Placebo application during surgery will be made to establish perfection in the study design in terms of randomization and blinding. Injections will be done intramuscularly to the main chest muscle (pectoralis major) by the surgeon. arm 2: Current standard post-operative care for expander-implant breast reconstruction surgery consists of conventional pain medications including narcotics (like morphine, etc.) and sedatives (like valium). Patients will receive through an injection into the chest 10 ml (about 2 teaspoons) of 0.5% bupivacaine during surgery. Injections will be done intramuscularly to the main chest muscle (pectoralis major) by the surgeon. arm 3: Current standard post-operative care for expander-implant breast reconstruction surgery consists of conventional pain medications including narcotics (like morphine, etc.) and sedatives (like valium). Patients will receive through an injection into your chest 50 U of Botox diluted in 4ml (about 1 teaspoon) of normal saline per breast during your operation. Injections will be done intramuscularly to the main chest muscle (pectoralis major) by the surgeon. arm 4: Current standard post-operative care for expander-implant breast reconstruction surgery consists of conventional pain medications including narcotics (like morphine, etc.) and sedatives (like valium). Patients will receive through an injection into your chest 10 ml (about 2 teaspoons) of 0.5% bupivacaine and 50 U of Botox diluted in 4ml (about 1 teaspoon) of normal saline per breast during the operation. Injections will be done intramuscularly to the main chest muscle (pectoralis major) by the surgeon.
Interventions: intervention 1: Bupivacaine intervention 2: Botulinum Toxins intervention 3: Analgesics
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02068846
Conditions: HIV Salivary Gland Disease Benign Lymphoepithelial Lesion
Keywords: HIV Salivary Gland Disease Benign Lymphoepithelial Lesion BK Polyomavirus
Sponsor: University of North Carolina, Chapel Hill
Start date: 2014-04-01; Completion date: 2016-01-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to analyze BK viral infection in salivary gland diseases; specifically, to determine a definitive relationship between BK Virus and HIV associated salivary gland disease (HIVSGD). Participants are adults HIV+SGD+ who will be randomized 1:1 to receive BK Virus antiviral (ciprofloxacin) or placebo for 28 days. Salivary function/protein secretion will be correlated with BK polyomavirus titers. It is expected that patients with HIV+SGD+ will have elevated oral BK polyomavirus viral loads and will benefit from Ciprofloxacin.

Detailed description:
The study duration is 12 weeks with a baseline visit, a visit at 4 weeks and a visit at 12 weeks. At baseline participants are randomized to Ciprofloxacin or placebo and take the drug or placebo for 28 days. At subsequent visits BK polyomavirus presence and salivary gland function will be assessed.

Arms: arm 1: Active treatment twice daily for 28 days arm 2: Placebo treatment twice daily for 28 days
Interventions: intervention 1: Ciprofloxacin intervention 2: Placebo
Intervention descriptions: intervention 1: Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days. intervention 2: Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.

Protocol documents:
Clinical trial NCT02081599
Conditions: Type 2 Diabetes Mellitus
Keywords: insulin resistance
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2014-01-01; Completion date: 2016-01-01
Enrollment: 148 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of Teneligliptin in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration and to evaluate the safety and efficacy of Teneligliptin in combination with Insulin with an extension treatment for up to 52 weeks.

Detailed description:

Arms: arm 1: Teneligliptin for 16 weeks (double-blind period) followed by teneligliptin for an additional 36 weeks (open-label period) in combination with insulin. arm 2: Placebo for 16 weeks (double-blind period) followed by teneligliptin for an additional 36 weeks (open-label period) in combination with insulin.
Interventions: intervention 1: Teneli (Teneligliptin) intervention 2: Placebo intervention 3: Insulin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02104414
Conditions: Hemorrhoid
Keywords: Liposomal Bupivacaine Exparel
Sponsor: St. Luke's-Roosevelt Hospital Center
Start date: 2014-04-01; Completion date: 2016-01-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the quality and duration of pain relief after a hemorrhoidectomy, provided by locally administered liposomal bupivacaine versus bupivacaine hcl or control with saline. It is hypothesized that liposomal bupivacaine will provide more effective postoperative pain relief than both bupivacaine hcl and the control.

Detailed description:

Arms: arm 1: 266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL) arm 2: 75mg/30mL 0.25% Bupivacaine HCl with epinephrine arm 3: 30mL Normal Saline
Interventions: intervention 1: Exparel intervention 2: Bupivacaine HCl with Epinephrine intervention 3: Normal Saline
Intervention descriptions: intervention 1: 266 mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL) intervention 2: 75mg/30mL 0.25% Bupivacaine HCl with epinephrine intervention 3: 30mL Normal Saline

Protocol documents:
Clinical trial NCT02129478
Conditions: Chemotherapy-induced Nausea and Vomiting
Keywords: olanzapine pediatrics chemotherapy-induced nausea chemotherapy-induced vomiting
Sponsor: The Hospital for Sick Children
Start date: 2014-03-01; Completion date: 2016-01-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Olanzapine is licensed for use in adults in Canada and in teens in the US with mental illness. It is also often used for the management of mental illness in children. This study will describe the feasibility of giving olanzapine plus other usual medications to prevent chemotherapy induced nausea and vomiting (CINV) to 15 children aged 4 to 18 years.

What has been done already? - In adult cancer patients, olanzapine improved the control of CINV. None of the adults studied experienced any serious side effects from olanzapine.

What is being studied and how will the study be conducted? - On each day that chemotherapy is given, olanzapine will be given to 15 children along with their regular medications to prevent CINV. Investigators will study each child only during one chemotherapy cycle. Participants' blood sugar, liver function tests (AST and ALT), prolactin and triglyceride levels, blood pressure, weight, mood and behavior during the time they receive olanzapine will be evaluated to see if they change. Investigators will record anything serious that happens while children receive olanzapine. If any child stops olanzapine early or decides to decrease the dose, the reason will be recorded. Each child and their guardian will record their nausea severity and the times they vomit or retch on each day they receive chemotherapy and for 8 days afterwards.

How will the study help? - This study will help investigators decide if it is feasible to conduct a larger study to find out if olanzapine improves CINV control in children. If most children are able to take olanzapine as set out in the study without having significant side effects, then a larger study would be feasible.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Olanzapine
Intervention descriptions: intervention 1: Patients will receive olanzapine once daily starting just before the first dose of chemotherapy within the study chemotherapy block and continuing until discharge from hospital or for a maximum of 4 doses after the last dose of chemotherapy.

Olanzapine will be dosed at 0.14mg/kg/dose (maximum 10mg/dose) as a single daily oral dose rounded to the nearest increment of a half-tablet (2.5mg).

Protocol documents:
Clinical trial NCT02142608
Conditions: Prostate Cancer
Keywords: Prostate cancer Ultrasound Imaging
Sponsor: Bracco Diagnostics, Inc
Start date: 2014-08-01; Completion date: 2016-01-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Pilot study to evaluate the ability of BR55 to identify prostate cancer lesions with Gleason Score ≥7 by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology results

Detailed description:
This multi-centre, open label, prospective, pilot study was designed to assess the ability of BR55 to detect VEGFR2 in human prostate cancer by Ultrasound Molecular Imaging (USMI). The binding of BR55 to VEGFR2 (focal enhancement still visible after significant decrease in signal from circulating microbubbles seen) was assessed at USMI and VEGFR2 expression was to be confirmed by immunohistochemistry (IHC) analysis including VEGFR2 and CD31 staining.

Arms: arm 1: All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg...
Interventions: intervention 1: BR55
Intervention descriptions: intervention 1: Ultrasound contrast agent

Protocol documents:
Clinical trial NCT02143973
Conditions: Uremic Pruritus Pruritus
Keywords: Uremic Pruritus Itch Chronic Itch Nalbuphine
Sponsor: Trevi Therapeutics
Start date: 2014-09-01; Completion date: 2016-01-01
Enrollment: 167 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER tablets during a treatment period of up to 24 weeks.

Detailed description:

Arms: arm 1: nalbuphine HCl ER titrated from a dose of 30 mg QD to 120 BID for up to 3 weeks based on tolerability and efficacy, then maintained for an additional 21 weeks. Total duration of 24 weeks.
Interventions: intervention 1: nalbuphine HCl ER
Intervention descriptions: intervention 1: nalbuphine HCl ER

Protocol documents:
Clinical trial NCT02144012
Conditions: Metastatic Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2014-06-01; Completion date: 2016-01-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase III, randomized, multicenter, multinational, two-arm, open-label clinical trial to investigate a first-line treatment of participants with human epidermal growth factor receptor-2 (HER2)-positive metastatic breast cancer. The study will enroll patients with HER2-positive, unresectable, locally advanced breast cancer (BC) if they have recurrent disease or progressive disease (PD) despite primary multi-modality therapy, and/or metastatic BC if they have not received prior chemotherapy for their metastatic disease. Eligible participants at up to approximately 40 sites in the Asia-Pacific region will be randomized in a 2:1 ratio to receive trastuzumab emtansine (Arm A) or trastuzumab plus docetaxel (Arm B). All study drugs will be administered at in-clinic visits occurring every three weeks during the treatment phase. Trastuzumab plus docetaxel was chosen as the comparator in the control group (Arm B), as it represents a common first-line treatment option used in this patient population in China and other Asia-Pacific countries.

Detailed description:

Arms: arm 1: Participants will be administered trastuzumab emtansine once every three weeks (Q3W). Participants may remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first. arm 2: Participants will be administered trastuzumab plus docetaxel Q3W. Participants may remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.
Interventions: intervention 1: Trastuzumab intervention 2: Trastuzumab Emtansine intervention 3: Docetaxel
Intervention descriptions: intervention 1: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W. intervention 2: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W. intervention 3: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m\^2) or 100 mg/m\^2 Q3W.

Protocol documents:
Clinical trial NCT02153723
Conditions: Rett Syndrome
Keywords: Treatment trial, Rett syndrome, Glatiramer acetate
Sponsor: Montefiore Medical Center
Start date: 2013-08-01; Completion date: 2016-01-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A phase 2 open label trial to test a potential drug treatment for Rett syndrome, the leading known genetic cause of severe neurological impairment in girls. The drug, Copaxone (generic name - Glatiramer acetate) is medication FDA approved for the treatment of multiple sclerosis. Copaxone's high safety profile has been documented in large cohorts of patients for more than 12 years.

Detailed description:
Background/rationale for the study:

In Rett syndrome brain cells aren't actually lost, instead poor maturation of connections between brain cells (synapses) prevents effective neurological functioning, and is the main morphological feature of the disease. The MeCP2 gene plays a major role in transcriptional regulation of other genes, one of which is the gene encoding brain-derived neurotrophic factor (BDNF).

The disease progression and severity of symptoms is directly affected by the level of BDNF expression. An increase of BDNF levels (by genetic manipulations or pharmacological agents) leads to delayed onset of Rett syndrome-like symptoms in experimental models; rescued gait/mobility, improved quality of life and increased survival rates.

Copaxone treatment by subcutaneous injection caused elevation of BDNF levels. Quantitative immunofluorescence assays showed about a twofold increase in neuronal expression of BDNF following Copaxone treatment.

We expect that an increase in BDNF levels with Copaxone administration will stimulate communication between brain cells (synaptic maturation), which will lead to amelioration of symptoms (motor functions/gait, cognitive functions, breathing, encephalopathy and improve quality of life) for girls with Rett syndrome.

Arms: arm 1: Dose escalation:

Study drug will be administered once a week for 4 weeks, twice a week for 4 weeks and daily for 24 weeks. Drug is administered as a subcutaneous injection.
Interventions: intervention 1: Glatiramer Acetate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02186665
Conditions: Plaque Psoriasis
Sponsor: Galderma R&D
Start date: 2014-07-01; Completion date: 2016-01-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety, efficacy and calcium metabolism of up to 8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis.

Detailed description:

Arms: arm 1: calcitriol 3 mcg/g ointment arm 2: placebo comparator
Interventions: intervention 1: calcitriol ointment intervention 2: placebo comparator
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02203630
Conditions: Septic Shock Sepsis Shock Tachycardia Arrhythmia
Keywords: Septic shock Vasopressor Agents Phenylephrine Norepinephrine Tachycardia Heart Rate Arrhythmia Catecholamine
Sponsor: Vanderbilt University Medical Center
Start date: 2014-08-01; Completion date: 2016-01-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Septic shock is a condition that is marked by severe infection causing hypotension requiring vasopressors to maintain adequate perfusion to vital organs. The Surviving Sepsis campaign, an international organization formed for the purpose of guiding the management of sepsis and septic shock, currently recommends norepinephrine as the first-choice vasopressor for septic shock. Phenylephrine, a vasopressor FDA-approved for use in septic shock, is recommended as an alternative vasopressor when septic shock is complicated by tachyarrhythmia to mitigate cardiac complications. This recommendation is based solely on experience with no scientific evidence to support this recommendation.

The investigators will conduct an open-label randomized controlled trial (RCT) directly comparing phenylephrine and norepinephrine, two FDA-approved vasopressors that are both used in clinical practice for the management of septic shock. The investigators will perform this study with a population of patients that have septic shock to complete the following aims:

Aim 1: Determine the incidence of tachyarrhythmias.

Aim 2: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a lower heart rate.

Aim 3: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a higher incidence of new tachyarrhythmias.

Aim 4: Determine which vasopressor, phenylephrine or norepinephrine, is associated with less time in tachyarrhythmia.

Aim 5: Determine which vasopressor, phenylephrine or norepinephrine, is associated with fewer complications, including cardiac complications.

The investigators hypothesize that in this setting, phenylephrine will improve the management of septic shock when used as a "first choice" vasopressor by:

1. Decreasing the mean heart rate
2. Decreasing the incidence of new tachyarrhythmias
3. Decreasing the amount of time spent in tachyarrhythmia for patients who develop new onset and recurrent tachyarrhythmias
4. Decreasing the number of cardiac complications

Detailed description:

Arms: arm 1: Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock arm 2: Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock
Interventions: intervention 1: Phenylephrine intervention 2: Norepinephrine
Intervention descriptions: intervention 1: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock intervention 2: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock

Protocol documents:
Clinical trial NCT02216357
Conditions: Aspirin Exacerbated Respiratory Disease (AERD)
Keywords: Samster's triad Acetylsalicylic acid triad Widal's triad Francis' triad Aspirin triad Aspirin-induced asthma and rhinitis (AIAR)
Sponsor: Cumberland Pharmaceuticals
Start date: 2014-08-01; Completion date: 2016-01-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to determine the safety of oral ifetroban compared to placebo as measured by a \> 20% decrease in FEV1 compared to baseline following a dose of Investigational Medicinal Product (IMP) (Study Day 1 or 2) prior to initiation of the aspirin challenge.

Detailed description:

Arms: arm 1: Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3. arm 2: Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Interventions: intervention 1: Ifetroban, Oral Capsule intervention 2: Placebo, Oral Capsule
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: