ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01262339
Conditions: Primary Focal Hyperhidrosis of the Hands
Keywords: Primary focal hyperhidrosis interdermal injections iontophoresis BTX-A
Sponsor: University of Wisconsin, Madison
Start date: 2010-11-01; Completion date: 2012-11-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary focal hyperhidrosis (excessive sweating) is a debilitating condition affecting approximately 3% of the population in the United States. Not only that it is a major social embarrassment to affected individuals, it also has significant negative impacts on career, school, and relationship. Botulinum toxin A (BTX-A), a sterile neurotoxin purified from Clostridium bacteria, was approved by the U.S. Food \& Drug Administration in 2004 for the treatment of severe focal axillary hyperhidrosis that does not respond to topical antiperspirants. It is becoming a promising treatment for many patients suffering this condition. Over the past decade, the medication has also been used effectively for many other forms of focal hyperhidrosis such as the hands, feet, forehead, scalp and groin. Unfortunately, BTX-A injection for primary focal hyperhidrosis of the palms and soles are often limited by pain and post treatment muscle weakness associated with the procedure. Recent studies have demonstrated that BTX-A can be delivered across the skin via electric current using a medical device, called iontophoresis (FDA 510(k) clearance # K042590 or Phoresor IIPM700). Studies with limited number of patients have demonstrated promising results with this new treatment.

Detailed description:

Arms: arm 1: Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.
Interventions: intervention 1: BTX-A
Intervention descriptions: intervention 1: 100 units of BTX-A will be delivered subject's hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand

Protocol documents:
Clinical trial NCT01266967
Conditions: Melanoma and Brain Metastases
Keywords: GSK2118436 Metastatic melanoma to the brain Brain metastases Braf mutation Brain neoplasm BRAF inhibitor
Sponsor: GlaxoSmithKline
Start date: 2011-02-01; Completion date: 2012-11-01
Enrollment: 172 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to assess the efficacy, pharmacokinetics, safety, and tolerability of an oral, twice daily dose of 150 mg GSK2118436 administered to subjects with BRAF V600E or V600K mutation-positive metastatic melanoma to the brain. Subjects in Cohort A will not have received any local brain therapy, and subjects in Cohort B will have received prior local therapy for brain metastases. Subjects will continue on treatment until disease progression, death, or unacceptable adverse event.

Detailed description:

Arms: arm 1: Single arm with 2 cohorts; Cohort A no previous brain therapy and Cohort B previous brain therapy
Interventions: intervention 1: GSK2118436
Intervention descriptions: intervention 1: Subjects in this study receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.

Protocol documents:
Clinical trial NCT01268566
Conditions: Glioblastoma Multiforme
Keywords: Glioblastoma
Sponsor: MedImmune LLC
Start date: 2011-01-01; Completion date: 2012-11-01
Enrollment: 62 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this Phase II study is to evaluate the progression-free survival at 6 months in adult subjects with a first recurrence of Glioblastoma Multiforme who are treated with MEDI-575.

Detailed description:
This is a Phase 2, multicenter, open-label, single-arm study to evaluate the antitumor activity, safety, and pharmacology of MEDI-575 in adult subjects with first recurrence of GBM.

Approximately 55 subjects will be enrolled to determine the preliminary efficacy profile of MEDI-575 in the treatment of subjects with first recurrence of GBM. Subjects will receive MEDI-575 as a 60-minute IV infusion on Day 1 every 21 days until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for subject withdrawal.

The primary assessment of antitumor activity is PFS-6; tumor response and progression will be determined using Updated Response Assessment Criteria of High Grade Gliomas- Neuro-Oncology Working Group v.1. Approximately 15 investigational sites in the United States will participate in this study. All subjects will be followed every 3 months for the duration of the trial (defined as 9 months from the date the last subject is entered into the trial or when the sponsor stops the study.

Arms: arm 1: MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minutes on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participants withdrawal.
Interventions: intervention 1: MEDI-575
Intervention descriptions: intervention 1: MEDI-575 as an IV infusion.

Protocol documents:
Clinical trial NCT01276756
Conditions: Chronic Hepatitis c
Sponsor: Cairo University
Start date: 2010-12-01; Completion date: 2012-11-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Chronic hepatitis C has become an endemic disease in Egypt with a rising prevalence (genotype 4), worldwide it also poses a significant health burden. To date standard of care treatment (pegylated interferon and ribavirin) give modest results with a sustained virological response (SVR) of about 50%. Several pharmaceutical and herbal agents have been used with an aim to improve current results. Recent reports have suggested an increased SVR with the addition of Nitazoxanide to standard of care. The results are preliminary and need to be confirmed. This is a randomized trial to assess the efficacy of nitazoxanide added to standard of care compared to standard of care alone.

Detailed description:

Arms: arm 1: Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks. arm 2: Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight \< 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
Interventions: intervention 1: Pegylated interferon alfa-2a intervention 2: Nitazoxanide intervention 3: Ribavirin
Intervention descriptions: intervention 1: Pegylated interferon 160ug once weekly 48 weeks intervention 2: Nitazoxanide 500mg twice daily 4 weeks lead-in followed by triple therapy 48 weeks intervention 3: Ribavirin (\> 75kg:1200 mg, \<75kg:1000mg daily)48 weeks

Protocol documents:
Clinical trial NCT01300819
Conditions: Idiopathic Parkinson's Disease
Keywords: Rotigotine Neupro® Non-motor symptoms
Sponsor: UCB Pharma
Start date: 2011-02-01; Completion date: 2012-11-01
Enrollment: 349 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to demonstrate that Rotigotine improves non-motor symptoms compared to Placebo in subjects with Parkinson's Disease.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: Rotigotine
Intervention descriptions: intervention 1: Placebo patches of 2, 4, 6 \& 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose was up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose was reached. Maximal dose was 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose was maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day. intervention 2: Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours

Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose was up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose was reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose was maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Protocol documents:
Clinical trial NCT01302067
Conditions: Overactive Bladder
Sponsor: Pfizer
Start date: 2011-05-01; Completion date: 2012-11-01
Enrollment: 2012 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. The study also assesses the side effects and safety of the two doses.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Fesoterodine 8mg intervention 2: Fesoterodine 4mg intervention 3: Placebo
Intervention descriptions: intervention 1: Oral, 1 tablet per day, 12 weeks duration, 8mg/day intervention 2: Oral, 1 tablet per day, 12 weeks duration, 4mg/day intervention 3: Oral, 1 tablet per day, 12 weeks duration

Protocol documents:
Clinical trial NCT01303003
Conditions: Prostate CA
Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Start date: 2010-12-01; Completion date: 2012-11-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Transversus abdominis plane (TAP) blocks are increasingly being performed after abdominal surgery to provide post operative analgesia. Dexamethasone has demonstrated an ability to prolong the effective duration of analgesia in several different peripheral nerve blocks. The study will examine, in a blinded, prospective and randomized fashion, whether the addition of dexamethasone to TAP blocks similarly prolongs blockade and pain relief. The study will compare local anesthetic with and without the addition of dexamethasone in the TAP block.

Detailed description:
The study will be done in two phases. In the first phase, patients will be randomized to receive either 20 cc of 0.125% bupivicaine with or without 2 mg of dexamethasone on each side of their abdomen (40 cc and 4 mg in total) and patients who receive the dexamethasone will be compared with patients who did not receive it. In the second phase, we will assess whether patients can serve as their own controls by adding dexamethasone only to one side of the block (one side of the abdomen) and comparing pain relief/efficacy with the contra-lateral plain local anesthetic effect. The study will assess pain relief, opioid consumption, level of blockade, and operator's prospective assessment of likely efficacy, based on the ultrasound visualization of the local anesthetic injection as compared with actual efficacy.

Arms: arm 1: Bilateral TAP block consisting of 40cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side. arm 2: Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side
Interventions: intervention 1: Dexamethasone intervention 2: TAP block
Intervention descriptions: intervention 1: 40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side. intervention 2: Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side

Protocol documents:
Clinical trial NCT01307930
Conditions: Obesity Mycoses
Keywords: Echinocandin Obesity Pharmacokinetics Pharmacodynamics Fungal infection
Sponsor: Texas Tech University Health Sciences Center
Start date: 2011-01-01; Completion date: 2012-11-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will find how weight affects the dosing of a drug called anidulafungin. Currently, the amount of anidulafungin a patient receives is the same regardless of the patient's weight. BMI groups were for enrollment purposes only and not used for ordinal data analysis.

Detailed description:
This study is designed to measure drug concentrations in the blood of volunteers administered a single intravenous dose of anidulafungin. The volunteers to be enrolled will not have either candidiasis or any other fungal infection. This is a single center study. Up to a total of 35 adult volunteers will be consented for the study at the Clinical and Translational Research Center (CTRC). Eighteen of these volunteers are needed to complete the study. The others will likely be screen failures, which is more likely in the BMI \> 40 kg/m2 group. Volunteers will be admitted to the CTRC for an overnight stay. Half will be female and half male. Six volunteers will have a body mass index (BMI) less than 25 kg/m2, six will have a BMI 25-40 kg/m2, and six will have a BMI greater than 40 kg/m2.

\*\* BMI groups will only be used for patient enrollment and not for data analysis. total body weight will be used as a continuous variable for data analysis. \*\*

Volunteers will have height and weight measured after they have consented to participate. All volunteers in each category will receive a single dose of intravenous anidulafungin of 100 mg. The volunteers will have blood drawn via an intravenous catheter just prior to the dose, and then at 1.5, 8, 16, and 24h after the drug dose. The intravenous catheter is then removed after the 24h blood draw, and the volunteer discharged from the study. The volunteer will be asked to return to the CTRC outpatient center at 48 and 72 hours to have the final 2 blood draws conducted. Subjects who are excluded from study participation due to their laboratory results will be provided with a copy of their results and an explanation of the reason for ineligibility.

Arms: arm 1: Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.
Interventions: intervention 1: Anidulafungin
Intervention descriptions: intervention 1: Anidulafungin 100 mg IV (each volunteer will only receive one dose of the study drug)

Protocol documents:
Clinical trial NCT01308424
Conditions: Oral Herpes Simplex
Keywords: Herpes Labialis Herpes Simplex Herpes
Sponsor: Beech Tree Labs, Inc.
Start date: 2011-01-01; Completion date: 2012-11-01
Enrollment: 171 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if a new treatment is effective for the treatment of recurrent symptomatic oral herpes virus infections.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: BTL TML HSV intervention 2: Matching placebo
Intervention descriptions: intervention 1: Sublingual micro-dosing for 7 days intervention 2: sublingual dosing for 7 days

Protocol documents:
Clinical trial NCT01327599
Conditions: Open-Angle Glaucoma Ocular Hypertension Pigment Dispersion Glaucoma
Keywords: Open-angle glaucoma Ocular hypertension Pigment dispersion glaucoma Intraocular pressure
Sponsor: Alcon Research
Start date: 2011-08-01; Completion date: 2012-11-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to assess the efficacy and tolerability of changing to DUOTRAV® from prior bimatoprost 0.03%/timolol 0.5% pharmacotherapy in subjects with open-angle glaucoma or ocular hypertension having uncontrolled intraocular pressure (IOP).

Detailed description:

Arms: arm 1: Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
Interventions: intervention 1: Travoprost 0.004%+Timolol 0.5% ophthalmic solution
Intervention descriptions: intervention 1: Fixed dose combination topical ocular agent preserved with polyquaternium-1 (POLYQUAD)

Protocol documents:
Clinical trial NCT01333592
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes HbA1c Long-term study
Sponsor: Kissei Pharmaceutical Co., Ltd.
Start date: ; Completion date: 2012-11-01
Enrollment: 136 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the long-term safety and efficacy of KAD-1229 as combination therapy with biguanide or DPP-4 inhibitor in type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: KAD-1229
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01339091
Conditions: Abscess Wound Infection Surgical Site Infection Cellulitis
Sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc
Start date: 2011-03-01; Completion date: 2012-11-01
Enrollment: 573 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proven gram-positive bacterial skin or skin structure infection.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dalbavancin intervention 2: Vancomycin / Linezolid
Intervention descriptions: intervention 1: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8 intervention 2: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.

Protocol documents:
Clinical trial NCT01339260
Conditions: Chemotherapy-Induced Nausea and Vomiting
Sponsor: Helsinn Healthcare SA
Start date: 2011-04-01; Completion date: 2012-11-01
Enrollment: 1455 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with oral dexamethasone. The objective of the study is to demonstrate that netupitant and palonosetron are more effective than palonosetron alone, to prevent nausea and vomiting induced by moderately emetogenic cancer chemotherapy after administration of repeated cycles of chemotherapy.

Detailed description:
NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with oral dexamethasone. Study is organised in two phases: cycle-1 and a multi-cycle extension. Safety assessment is performed separately in cycle 1 (arm 1 and arm 2) and in multi-cycle extension (arm 3 and arm 4).

Arms: arm 1: Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle arm 2: Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle arm 3: Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle arm 4: Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
Interventions: intervention 1: Netupitant and Palonosetron intervention 2: Palonosetron intervention 3: Dexamethasone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01363479
Conditions: Chemotherapy-Induced Nausea and Vomiting
Sponsor: Helsinn Healthcare SA
Start date: 2011-07-01; Completion date: 2012-11-01
Enrollment: 743 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
PALO-10-01 is a clinical study assessing efficacy and safety of a single oral dose of palonosetron compared to a single intravenous dose of palonosetron (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that oral palonosetron 0.50 mg is as effective as (non-inferior to) palonosetron IV 0.25 mg to prevent nausea and vomiting induced by highly emetogenic cancer chemotherapy in the 0-24 hours after administration of a single cycle of highly emetogenic chemotherapy.

Detailed description:

Arms: arm 1: Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4. arm 2: Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Interventions: intervention 1: Oral palonosetron intervention 2: I.V. palonosetron intervention 3: Dexamethasone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01437878
Conditions: Chronic Obstructive Pulmonary Disease Pulmonary Hypertension
Keywords: PH COPD
Sponsor: Actelion
Start date: 2012-03-01; Completion date: 2012-11-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 2, Multi-center, double-blind, randomized, placebo-controlled study to evaluate the effects of inhaled Iloprost in patients with pulmonary hypertension secondary to COPD. The main objective is to investigate the effect of iloprost on exercise endurance time during constant work rate cardiopulmonary exercise testing. Other efficacy and safety endpoints will additionally be analyzed.

Detailed description:

Arms: arm 1: single dose inhalation using the power disc-6 with I-neb Adaptive Aerosol Delivery (AAD) system arm 2: matching placebo using the power disc-6 with I-neb AAD system
Interventions: intervention 1: Iloprost intervention 2: Placebo
Intervention descriptions: intervention 1: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks intervention 2: matching placebo

Protocol documents: