ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01767285
Conditions: Continuation Rate of Contraceptive Implant
Keywords: Etonogestrel Implant Implanon Nexplanon Long Acting Reversible Contraception
Sponsor: Duke University
Start date: 2013-01-01; Completion date: 2015-04-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators are examining if there is a difference in continuation rates of the etonogestrel contraceptive implant between women who have the device placed immediately after delivery, before leaving the hospital, and women who have the device placed at the routine 6-week postpartum visit. There will be 60 subjects total, randomized in a 1:1 ratio, for 30 in each group. All participants will follow-up at the same postpartum clinic 6 weeks after delivery. They will then be contacted at 3, 6, and 12 months postpartum and asked to complete a brief survey. The investigators hypothesize that continuation rates of Implanon will be higher in the immediate postpartum placement arm than in the delayed placement arm.

Detailed description:

Arms: arm 1: Etonogestrel implant placed in the hospital after delivery, before discharge home. arm 2: These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.
Interventions: intervention 1: Etonogestrel implant
Intervention descriptions: intervention 1: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.

Protocol documents:
Clinical trial NCT01777776
Conditions: Locally Advanced Metastatic BRAF Mutant Melanoma
Keywords: Open-label dose escalation BRAF inhibitor LEE011 CDK4/6 LGX818 RAF kinase inhibitor Metastatic melanoma BRAF V600
Sponsor: Array BioPharma
Start date: 2013-07-01; Completion date: 2015-04-01
Enrollment: 28 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety, tolerability and efficacy of LEE011 and LGX818 when administered orally to patients with BRAF mutant melanoma.

Detailed description:
In response to developments in the treatment of melanoma, the sponsor reviewed the data from the ongoing study and decided to halt further enrollment of patients in the Phase Ib part of the study. Consequently, the Phase II part of the study was not performed. Early termination of the study was not due to any safety concerns.

Arms: arm 1: Phase Ib will randomize 18 patients with BRAF mutant melanoma, who are naïve or who have progressed on prior therapy to evaluate the safety and tolerability of the combination of LEE011 and LGX818. arm 2: Phase II arm 1a will randomize 60 patients that are naïve to prior BRAF inhibitor therapy to LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population. arm 3: Phase II arm 1b will randomize 30 patients to LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population. arm 4: Phase II arm 2 will evaluate a single arm LEE011+LGX818 in 40 patients resistant to prior BRAF inhibitor therapy. Single agent LGX818 has shown limited activity in patients with melanoma who have failed prior BRAF inhibitor treatment; the contribution of LEE011 in this combination will be evaluated.
Interventions: intervention 1: LEE011 intervention 2: LGX818
Intervention descriptions: intervention 1: LEE011 will be administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle). intervention 2: LGX818 will be administered orally, once daily on a continuous dosing schedule (28-day cycle).

Protocol documents:
Clinical trial NCT01787916
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes overweight insulin liraglutide
Sponsor: CHU de Quebec-Universite Laval
Start date: 2013-04-01; Completion date: 2015-04-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To our knowledge, no trial has specifically studied the effect of liraglutide combined with a basal/bolus insulin regimen in type 1 diabetes in a cross-over, double-blind, unicentric model. Moreover, the potential impact of a glucagon-like peptide-1 agonist on measures of abdominal fat (assessed by CT scan), insulin sensitivity (assessed by the gold standard euglycemic-hyperinsulinemic clamp) and satiety sensations have not been evaluated in this population.

Hypothesis Overweight participants with type 1 diabetes on liraglutide/insulin treatment will present improved glucose control with decreased HbA1c, decreased fasting and mean weekly glucose concentrations and glycemic excursions as well as increased insulin sensitivity compared to participants on placebo/insulin treatment. Participants with liraglutide/insulin treatment will also present improved endothelial function, lower body weight, central adipose tissue assessed by CT scan and higher satiety sensations assessed by visual analogue scales.

Detailed description:
Participants will be submitted to this double-blind cross-over protocol of 52-week use of liraglutide/placebo.

Arms: arm 1: Liraglutide, s.c., 1.8 mg, die, 24 weeks arm 2: Liraglutide placebo (visually identical to study drug) will be given s.c. 1.8 mg for 24 weeks
Interventions: intervention 1: Liraglutide intervention 2: Placebos
Intervention descriptions: intervention 1: Liraglutide will be compared to placebo for 24 weeks in a cross-over design intervention 2: placebo will be compared to liraglutide for 24 weeks in a cross-over design

Protocol documents:
Clinical trial NCT01847092
Conditions: Chronic Kidney Disease Type 2 Diabetes Mellitus
Keywords: albuminuria
Sponsor: Ardelyx
Start date: 2013-05-01; Completion date: 2015-04-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the study drug is safe, tolerable and active in reducing albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes.

Detailed description:

Arms: arm 1: AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks arm 2: Placebo capsule BID PO for 12 Weeks
Interventions: intervention 1: AZD1722 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Placebo for AZD1722

Protocol documents:
Clinical trial NCT01854047
Conditions: Asthma
Sponsor: Sanofi
Start date: 2013-06-01; Completion date: 2015-04-01
Enrollment: 776 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

To evaluate the efficacy of different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma.

Secondary Objective:

To evaluate different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma, with regard to:

* Safety and tolerability
* Dupilumab systemic exposure and anti-drug antibodies

Detailed description:
Total duration per participant of approximately 43 weeks including a screening period (14-21 days), a randomized treatment period (24 weeks), and a post-treatment period (16 weeks).

Arms: arm 1: 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable inhaled corticosteroid/ long-acting beta-agonist (ICS/LABA) therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. arm 2: 2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. arm 3: 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. arm 4: 2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. arm 5: 2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Interventions: intervention 1: Dupilumab intervention 2: placebo intervention 3: ICS/LABA therapy intervention 4: Salbutamol/albuterol intervention 5: Levosalbutamol/levalbuterol
Intervention descriptions: intervention 1: Solution for injection, Subcutaneous injection intervention 2: Solution for injection, Subcutaneous injection intervention 3: Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose intervention 4: Oral inhalation as needed intervention 5: Oral inhalation as needed

Protocol documents:
Clinical trial NCT01876043
Conditions: Adult Patients With Unresectable Locally Advanced or Metastatic, Relapsed/Refractory Dedifferentiated Liposarcoma
Sponsor: Institut Bergonié
Start date: 2012-02-01; Completion date: 2015-04-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Liposarcomas are soft tissue sarcomas most frequent. We distinguish three subtypes on the basis of their histological and cytogenetic characteristics: well-differentiated liposarcoma / dedifferentiated, myxoid liposarcoma and / or round cell liposarcoma and pleomorphic. Dedifferentiated liposarcomas (LDD) represent 20% of liposarcomas and are characterized by well-differentiated component associated with a contingent sarcomatous differentiation and fat-usually high grade. The LDD are most often rétropértionéal seat. Thus, their development is very long asymptomatic. At diagnosis, tumor volume is often very important making surgical removal impossible in a high proportion of cases. Operable tumors have also a risk of local recurrence by about 50% and about 20% metastatic. Chemotherapy is the only treatment of these advanced forms. However, the currently available drugs (adriamycin, ifosfamide) have only very limited effectiveness. Progression-free survival of patients does not exceed 2 months. The LDD is characterized cytogenetically by the constant presence of two amplicons (1p32 and 6q23) respectively targeting genes MAP3K5 and JUN. These two genes encode proteins involved in the signaling pathway Jun N-terminal kinase (JNK). Activation of JNK is involved in the loss of adipose differentiation and tumor aggressiveness of LDD. The plitidepsin is a drug capable of inducing apoptosis of tumor cells carrying a functional activation of the JNK pathway. This drug has such a pro-apoptotic and anti-proliferative in vitro models of LDD. plitidepsin could represent the treatment of choice for patients with advanced LDD. The objective of this study is to evaluate the anti-tumor activity of plitidepsin patients with locally advanced dedifferentiated liposarcomas and / or metastatic.

Detailed description:

Arms: arm 1: plitidepsin
Interventions: intervention 1: plitidepsin
Intervention descriptions: intervention 1: Patients received plitidepsin as an i.v. 3-h infusion of 5 mg/m2/day on days 1 and 15 every 4 weeks. Patients discontinued plitidepsin if one of the following occurred: consent withdrawal, unacceptable toxicity, disease progression (RECIST v1.1), intercurrent illness or investigator's decision.

Single-arm phase II clinical trial based on a two-stage optimal Simon's design with 37 evaluable patients (first stage: 17 patients) used to distinguish a favorable true non-progression rate of 40% from a null rate of 20% (90% power and 10% type I error).

* Stage 1(17 participants): if \<=3 non-progressions at 3 months, the study was stopped early. Otherwise, the second group of 20 participants was recruited.
* Stage 2 (37 participants): if \>= 11 non-progressions, Aplidin was considered promising.

Protocol documents:
Clinical trial NCT01886313
Conditions: Postherpetic Neuralgia
Keywords: Herpes Zoster Postherpetic Neuralgia Shingles Civamide Zucapsaicin Neuropeptides TRPV-1
Sponsor: Winston Laboratories
Start date: 2014-03-01; Completion date: 2015-04-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Herpes zoster (commonly referred to as "shingles") results from the reactivation of the varicella-zoster virus acquired during a primary infection, usually chickenpox. The virus lays dormant in the cells of the nerves until activated. Once activated, patients develop a characteristic red blistering rash which crusts and heals in 2 - 4 weeks. Postherpetic neuralgia (PHN), the term for pain persisting after the herpes zoster (HZ) eruption heals, is the most common and most feared complication of herpes zoster infection. The drug, Civamide is thought to desensitize the nerves and decrease the pain of PHN. This is the pharmacologic rationale for its use in the nose in postherpetic neuralgia of the trigeminal nerve, a nerve that is in the nose and transmits pain from the face. The objective of this study is to evaluate the safety and efficacy of intranasally administered Civamide (0.01%) for the treatment of moderate to severe daily pain associated with postherpetic neuralgia of the trigeminal nerve. Neuropathic pain must have persisted for ≥ 12 months.

Detailed description:

Arms: arm 1: Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks arm 2: Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks
Interventions: intervention 1: Civamide Nasal Spray intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01893879
Conditions: Lymphedema Unspecified Adult Solid Tumor, Protocol Specific
Sponsor: Stanford University
Start date: 2014-04-01; Completion date: 2015-04-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized clinical trial studies an investigational drug in preventing lymphedema in patients at high risk after undergoing axillary lymph node dissection. The study drug may prevent lymphedema in patients undergoing axillary lymph node dissection.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the efficacy of study drug in improving chronic lymphedema while further elucidating the role of inflammatory and lymphangiogenic processes in the pathogenesis of this disease.

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

ARM I: Patients receive study drug orally (PO) thrice daily (TID) for up to 1 year in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 5 years.

Arms: arm 1: Patients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.

Laboratory biomarker analysis will be performed. arm 2: Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.

Laboratory biomarker analysis will be performed.
Interventions: intervention 1: placebo for study drug intervention 2: (RS)2-(3-benzoylphenyl)-propionic acid intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01894568
Conditions: Type 2 Diabetes Mellitus
Sponsor: Eli Lilly and Company
Start date: 2013-07-01; Completion date: 2015-04-01
Enrollment: 388 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare insulin peglispro (LY2605541) to insulin glargine in Asian insulin naïve participants who have been treated with oral anti hyperglycemia medications. Participants will receive 26 weeks of treatment.

Detailed description:

Arms: arm 1: Insulin Peglispro administered subcutaneously (SC) once daily for 26 weeks in combination with Oral Antihyperglycemic Medications (OAMs). arm 2: Insulin Glargine administered SC once daily for 26 weeks in combination with OAMs.
Interventions: intervention 1: Insulin Peglispro intervention 2: Insulin Glargine intervention 3: Oral Antihyperglycemic Medications (OAMs)
Intervention descriptions: intervention 1: Administered SC using a prefilled pen. intervention 2: Administered SC using a prefilled pen intervention 3: Administered orally

Protocol documents:
Clinical trial NCT01898403
Conditions: Recurrent Melanoma
Sponsor: Stanford University
Start date: 2013-06-01; Completion date: 2015-04-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial compares and contrasts lymph node mapping using indocyanine green (IC-GREEN), isosulfan blue (ISB), and TSC and Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC).

Study participants with malignant melanoma will undergo all 3 evaluations to assess the extent of the spread of the melanoma.

Detailed description:
PRIMARY OBJECTIVES:

I. To show that indocyanine green (ICG) (indocyanine green solution) is equal to both isosulfan blue (ISB) and technetium Tc 99m sulfur colloid (TSC) and will allow all lymph node mapping to occur in the operating room (OR).

OUTLINE:

Patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution. During surgery, patients undergo identification of the sentinel lymph node and imaging using a laser with videocamera (SPY Elite camera).

Arms: arm 1: All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.
Interventions: intervention 1: Indocyanine green solution intervention 2: Isosulfan blue (ISB) intervention 3: Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)
Intervention descriptions: intervention 1: Administered peri-tumoral and intradermally intervention 2: Administered peri-tumoral and intradermally intervention 3: None

Protocol documents:
Clinical trial NCT01900704
Conditions: Nocturia
Sponsor: Serenity Pharmaceuticals, Inc.
Start date: 2013-08-01; Completion date: 2015-04-01
Enrollment: 810 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia

Detailed description:

Arms: arm 1: SER120 750 ng arm 2: SER120 1500 ng arm 3: Placebo
Interventions: intervention 1: SER120 750 ng intervention 2: SER120 1500 ng intervention 3: Placebo
Intervention descriptions: intervention 1: SER120 750 ng intervention 2: SER120 1500 ng intervention 3: Placebo

Protocol documents:
Clinical trial NCT01904058
Conditions: PBC Primary Biliary Cirrhosis
Keywords: PBC
Sponsor: Mirum Pharmaceuticals, Inc.
Start date: 2013-08-01; Completion date: 2015-04-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is a randomized, double-blind, placebo-controlled, multicenter study. It is a 13-week Phase 2 study in adults with primary biliary cirrhosis designed to compare the effect of daily dosing with UDCA in combination with LUM001 or placebo.

Detailed description:

Arms: arm 1: Administered orally once daily arm 2: Administered orally once daily
Interventions: intervention 1: LUM001 intervention 2: Placebo intervention 3: Ursodeoxycholic Acid
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01921296
Conditions: Sleep Initiation and Maintenance Disorders Pain
Keywords: Breast cancer Aromatase inhibitor
Sponsor: Lynn Henry
Start date: 2013-08-01; Completion date: 2015-04-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Many women with breast cancer who are treated with aromatase inhibitor medications develop difficulty sleeping and fatigue during treatment. Some examples of aromatase inhibitor medications include anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara). Frequently, sleeping pills do not work very well to improve sleep. Cyclobenzaprine (Flexeril) is a medication that was originally developed to treat muscle spasms. It may also improve sleep in patients with chronic pain disorders, such as fibromyalgia. In this study we are testing to see if cyclobenzaprine at bedtime will help improve sleep in women treated with aromatase inhibitors.

Detailed description:

Arms: arm 1: Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
Interventions: intervention 1: Cyclobenzaprine
Intervention descriptions: intervention 1: 5 milligrams orally 2 hours before bedtime

Protocol documents:
Clinical trial NCT01939496
Conditions: Diabetes Mellitus, Type 2 Hypertension
Keywords: Diabetes Mellitus, Type 2 Hypertension Canagliflozin JNJ 28431754 Sodium-Glucose Transporter 2 Blood Glucose Type 2 Diabetes Mellitus
Sponsor: Janssen Scientific Affairs, LLC
Start date: 2013-10-01; Completion date: 2015-04-01
Enrollment: 171 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of canagliflozin (JNJ-28431754) on blood pressure reduction, compared to placebo, in patients with hypertension and type 2 diabetes mellitus and who are on stable doses of anti-hyperglycemic and anti-hypertensive agents. Overall safety and tolerability of canagliflozin will be assessed.

Detailed description:
This is a randomized (study drug assigned by chance), double blind (neither the patient nor the study doctor will know the name of the assigned treatment), parallel-group, 3-arm (patients will be assigned to 1 of 3 treatment groups) multicenter study to determine the effect of canagliflozin (100 mg and 300 mg) on blood pressure (BP) reduction compared to placebo (a pill that looks like all the other treatments but has no real medicine) in patients with hypertension and type 2 diabetes mellitus (T2DM). The study will consist of 3 phases: a screening phase, a double-blind treatment phase and a follow-up period. Approximately 153 participants will be randomly assigned to 1 of 3 treatment groups (in a 1:1:1 ratio) in the double-blind treatment phase to receive canagliflozin 100 mg, canagliflozin 300 mg or placebo for 6 weeks. The total duration of participation in this study will be approximately 13 weeks.

Arms: arm 1: Each patient will receive 100 mg of canagliflozin once daily for 6 weeks. arm 2: Each patient will receive 300 mg of canagliflozin once daily for 6 weeks. arm 3: Each patient will receive matching placebo once daily for 6 weeks.
Interventions: intervention 1: Canagliflozin intervention 2: Placebo
Intervention descriptions: intervention 1: One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information. intervention 2: One matching placebo capsule orally in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.

Protocol documents: