ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01759277
Conditions: Postoperative Pain Following Knee Arthroplasty
Sponsor: University of California, San Diego
Start date: 2012-12-01; Completion date: 2014-09-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients typically experience moderate-to-severe pain following knee arthroplasty that is usually treated with a combination of oral and intravenous analgesics and enhanced by continuous peripheral nerve blocks. There are currently two locations to place a perineural catheter to provide analgesia following knee arthroplasty: a femoral nerve catheter and an adductor canal catheter. Both have been demonstrated to be effective following knee arthroplasty. However, it remains unknown if one location is superior to the other; or, more accurately, what the relative benefits are to each technique.

While femoral CPNB has many benefits, one of the challenges of using this technique is that there is a decrease in quadriceps muscle strength which can be a limiting factor for rehabilitation. In contrast, the adductor canal catheter affects only the vastus medialis. This block may lessen block-induced quadriceps weakness following knee arthroplasty compared with a femoral infusion.

The investigators hypothesize that compared with femoral perineural local anesthetic infusion, an adductor canal infusion is associated with a shorter time until four discharge criteria are met: (1) adequate analgesia; (2) independence from intravenous analgesics; (3) ability to ambulate 30 m; and (4) ability to stand, walk 3 m, and return to a sitting position without another's assistance.

Detailed description:
Of importance: The primary investigation involves 80 evaluable subjects (with primary endpoint data) having tri-compartment knee arthroplasty. In addition, the investigators will enroll up to 70 subjects having uni-compartment knee arthroplasty as a pilot study in preparation for a subsequent larger, definitive trial. These two groups will not be analyzed together--they represent two distinct studies: one a definitive RCT for tri-compartment knee arthroplasty; and, one a pilot study for uni-compartment knee arthroplasty.

Arms: arm 1: Femoral perineural local anesthetic infusion arm 2: Adductor canal perineural local anesthetic infusion
Interventions: intervention 1: Control: Femoral perineural local anesthetic infusion intervention 2: Experimental: Adductor Canal perineural local anesthetic infusion
Intervention descriptions: intervention 1: The control group will receive a femoral nerve block and postoperative ropivacaine 0.2% infusion intervention 2: The control group will receive an adductor canal nerve block and postoperative ropivacaine 0.2% infusion

Protocol documents:
Clinical trial NCT01761019
Conditions: Psoriasis
Keywords: psoriasis Taclonex Acitretin Methotrexate
Sponsor: University of Pittsburgh
Start date: 2013-01-01; Completion date: 2014-09-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Oral therapies for psoriasis, including methotrexate and acitretin, are often less effective when used as monotherapy (without other oral medicines or creams) than are newer biologic injected drugs. However, these oral medications are also less expensive than biologic agents and may be safer for use in some patients. The purpose of this study is to determine if adding a topical psoriasis medicine, calcipotriene/betamethasone topical suspension (Taclonex topical suspension), will improve the severity of psoriasis in patients already on methotrexate or acitretin and to determine if adding this topical suspension will reduce the desire of such patients to switch to a biologic agent to treat their psoriasis.

Detailed description:
Many patients with mild psoriasis are able to control disease symptoms with topical medications alone. There are a variety of topical options available, including corticosteroids, synthetic vitamin D3, vitamin A, coal tar, salicylic acid and a number of other products of varying efficacy. The combination topical suspension of calcipotriene 0.005% and betamethasone dipropionate 0.064% is a first-line treatment for moderate to severe psoriasis vulgaris and is FDA approved for use on the skin and scalp in adults 18 years and older. This treatment combines the pharmacological effects of calcipotriene hydrate as a synthetic vitamin D3 analog and betamethasone dipropionate as a synthetic corticosteroid. It is well tolerated and has a low rate of adverse events according to pooled safety data from 2700 patients who have used a calcipotriene/betamethasone combination in clinical trials. Calcipotriene/betamethasone topical suspension has also been shown to have a positive impact on patient quality of life, as seen in clinical trials utilizing patient reported outcomes such as the Dermatology Life Quality Index (DLQI) and Psoriasis Disability Index.

Calcipotriene/betamethasone topical suspension is a therapy commonly used to treat patients with mild to moderate psoriasis. Currently, there have been no formal trials studying the efficacy of calcipotriene/betamethasone topical suspension used in conjunction with methotrexate or acitretin. In order to better understand the effectiveness of this treatment combination, we conducted a preliminary, open label, single arm prospective study to determine the benefit of adding betamethasone-calcipotriene topical suspension to ongoing systemic psoriasis therapy in subjects who do not have complete clearance of psoriasis on a single systemic agent alone.

Arms: arm 1: Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks
Interventions: intervention 1: Taclonex Topical Suspension
Intervention descriptions: intervention 1: topical medication for psoriasis

Protocol documents:
Clinical trial NCT01764386
Conditions: Obesity Overweight
Keywords: obesity, overweight
Sponsor: Orexigen Therapeutics, Inc
Start date: 2013-02-01; Completion date: 2014-09-01
Enrollment: 242 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this Phase 3b study is to assess the effects of combination therapy with naltrexone SR/bupropion SR (NB) used in conjunction with a comprehensive lifestyle intervention (CLI) and in a manner consistent with its intended use after marketing approval, on body weight and cardiovascular risk factors compared to the effects of Usual Care in subjects who are overweight with dyslipidemia and/or controlled hypertension or obese. Subjects in the NB and CLI group are required to undergo an evaluation to continue treatment at Week 16. Subjects are to be discontinued from full participation if they do not lose at least 5% of their body weight relative to baseline and/or are experiencing sustained increases in blood pressure (systolic or diastolic) of ≥10 mmHg above baseline. At Week 26, subjects originally assigned to Usual Care switch to treatment with NB and CLI, and subjects assigned to NB and CLI continue treatment for the duration of the study (78-weeks treatment period).

Detailed description:

Arms: arm 1: Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with comprehensive lifestyle intervention (CLI) arm 2: Usual Care (self-directed lifestyle intervention)

Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff.
Interventions: intervention 1: NB intervention 2: CLI intervention 3: Usual Care
Intervention descriptions: intervention 1: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage) intervention 2: The Comprehensive Lifestyle Intervention (CLI) program includes telephone counseling, internet education, goal setting, and online tracking tools. intervention 3: Usual Care is a self-directed lifestyle intervention program

Protocol documents:
Clinical trial NCT01766713
Conditions: Non Alcoholic Steatohepatitis
Sponsor: University of California, San Diego
Start date: 2013-01-01; Completion date: 2014-09-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to see if the drug ezetimibe is a potential treatment for Nonalcoholic Steatohepatitis(NASH).

Detailed description:
Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of diseases ranging from simple steatosis to nonalcoholic steatohepatitis (NASH), the progressive form of liver disease that can lead to cirrhosis and liver-related mortality in persons who drink little or no alcohol. Nonalcoholic steatohepatitis (NASH) represents the more severe end of this spectrum and is characterized by steatosis, ballooning degeneration and lobular inflammation with or without fibrosis. The etiology of NASH is not completely understood, but it is often associated with obesity, type 2 diabetes, hyperlipidemia and insulin resistance. Lipotoxicity, insulin resistance and oxidative stress appear to be central to the pathogenesis of NASH. Currently, there is no FDA approved treatment for NAFLD/NASH. Weight loss and exercise are the recommended but often difficult maintain these lifestyle changes in the long term and therefore therapeutic agents have been investigated. Ezetimibe is an LDL lowering agent that works through inhibition of the fat absorption from the small intestine. In this study, we propose to treat 50 patients with NASH with either Ezetimibe or placebo for 24 weeks. After an initial evaluation for insulin sensitivity, MRI liver fat distribution and liver biopsy, patients will receive either 10 mg/day of Ezetimibe or placebo. Patients will be monitored at regular intervals for symptoms of liver disease, side effects of Ezetimibe and serum biochemical and metabolic indices. At the end of 24-weeks, patients will have a repeat medical evaluation, liver MRI and liver biopsy. Pre and post treatment MRI-derived liver fat content, liver histology and insulin sensitivity will be compared. The primary end point of successful therapy will be improvement in hepatic steatosis measured by MRI. Secondary end points will be improvement in insulin sensitivity, liver histology and liver biochemistry.

Arms: arm 1: 10 mg/day of Ezetimibe arm 2: one tablet per day (identical to ezetimibe)
Interventions: intervention 1: Ezetimibe
Intervention descriptions: intervention 1: 10mg daily oral dose of ezetimibe

Protocol documents:
Clinical trial NCT01767415
Conditions: Brain Tumors With Ill-defined Margins
Keywords: brain tumor resection indigo carmine dye
Sponsor: Weill Medical College of Cornell University
Start date: 2012-04-01; Completion date: 2014-09-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate whether stereotactic indigo carmine injection can safely increase the extent of tumor resection.

Detailed description:
Low grade gliomas are brain tumors with usually poorly defined borders between tumor and normal brain. This characteristic of low grade gliomas makes the gross total resection of the tumor extremely difficult. Nevertheless, several studies have demonstrated that the risk of recurrence and progression into a more malignant tumor can be decreased with a more aggressive surgical resection. An aggressive attempt to achieve a gross total resection may result in the resection of normal brain and therefore neurological injury. For this reason, the more common error is to subtotally resect the tumor leaving significant volumes of tumor behind. Many techniques have been introduced to safely increase the extent of resection, since the extent of resection is associated with a higher survival rate. Each one of these techniques has several shortcomings. The current study will assess whether the intraoperative stereotactic injection of the indigo carmine at the tumor margins helps to safely increase of extent of tumor resection. In the first step of the study the safety and the correlation between resection of stained tissue/extend of tumor resection will be assessed. If the results are satisfactory, then the second step will ensue. In the second step we will assess the utility of indigo carmine as an additional adjunct to guide tumor resection.

Arms: arm 1: Intraoperative stereotactic injection of Indigo Carmine
Interventions: intervention 1: Indigo carmine
Intervention descriptions: intervention 1: During resection, a small quantity of a special dye called indigo carmine will be infused at the margins of the tumor using computer-guided stereotactic navigation equipment. This dye will be visible during the tumor resection and it can potentially serve as an additional marker of the tumor margins. A post-operative MRI scan -which is part of the standard care- will accurately measure the extent of tumor resection.

Protocol documents:
Clinical trial NCT01767701
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: raltegravir MS RRMS Charcot Project
Sponsor: Queen Mary University of London
Start date: 2013-04-01; Completion date: 2014-09-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether raltegravir is effective in preventing progression of relapsing remitting multiple sclerosis as determined by gadolinium- enhanced MRI.

Detailed description:
There is accumulating research evidence that Human Endogenous Retrovirus (HERV) and herpes viruses (in particular Epstein-Barr Virus) are involved in the pathogenesis of multiple sclerosis. People with active MS have higher levels of HERVs than people either without MS or who have other neurological conditions. It has been shown that HERVs may produce neurotoxic proteins/antigens associated with MS activity and disease progression. This is the first clinical trial investigating the hypothesis that the antiretroviral drug raltegravir may suppress HERV activity and ameliorate progression of relapsing remitting MS. Raltegravir is an integrase inhibitor which blocks retroviral replication. A recent experimental study suggests that raltegravir may also be active against herpes viruses.

Eligible participants (see Inclusion/Exclusion Criteria) will be observed for 3 months having monthly brain Gadolinium enhanced MRIs and blood/urine/saliva sampling (baseline). Then they will be treated with raltegravir (one 400mg pill taken twice a day) for 3 months. During treatment period participants will continue to have monthly MRIs and blood/saliva/urine sampling. Participants will have monthly clinical and neurological examinations and they will complete questionnaires assessing response to treatment. Participants will have screening and study visits at The Royal London Hospital, Whitechapel. Monthly MRIs will be performed at the Institute of Neurology at Queens Square, London.

Arms: arm 1: All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.
Interventions: intervention 1: Raltegravir
Intervention descriptions: intervention 1: 400mg twice daily for 3 months

Protocol documents:
Clinical trial NCT01778062
Conditions: Patients With Moderate-to-severe COPD With Destroyed Lung by Tuberculosis
Sponsor: Novartis Pharmaceuticals
Start date: 2013-02-01; Completion date: 2014-09-01
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical study will assess efficacy and safety of indacaterol (150㎍ o.d.) in patients with Chronic Obstructive Pulmonary Disease (COPD) with destroyed lung by tuberculosis.

Detailed description:
There are few clinical studies in patients with COPD with destroyed lung by tuberculosis because tuberculosis patients are usually excluded from (phase II or III) clinical trials for drug registration although they are not prohibited from prescription of COPD drugs.

This clinical study will assess efficacy and safety of indacaterol (150㎍ o.d.) in patients with COPD with destroyed lung by tuberculosis.

Arms: arm 1: Indacaterol 150 µg once daily arm 2: Placebo once daily
Interventions: intervention 1: Indacaterol intervention 2: Control
Intervention descriptions: intervention 1: Indacaterol 150µg once daily oral inhalation intervention 2: Placebo once daily oral inhalation

Protocol documents:
Clinical trial NCT01788215
Conditions: Polycystic Ovarian Syndrome (PCOS) Irregular Menstrual Cycles Androgen Excess
Keywords: Polycystic Ovarian Syndrome Irregular Menstrual Cycles Androgen Excess in Women
Sponsor: University of Rochester
Start date: 2010-11-01; Completion date: 2014-09-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to study the effect of a commonly used antibiotic, doxycycline, on the production of ovarian hormones and menstrual cycles in women with Polycystic Ovarian Syndrome (PCOS).

Detailed description:
Polycystic ovarian syndrome (PCOS) is one of the leading causes of female infertility, affecting 5-10% of reproductive-age women . This heterogeneous disorder is characterized by anovulatory infertility, androgen excess, an increase in the ratio of LH to FSH, and morphologic polycystic changes to the ovaries. Obesity and insulin resistance are also metabolic factors associated with PCOS that further increase the morbidity in these patients. Inducing fertility in patients with PCOS can be a challenge, as it most often involves ovulation induction that can lead to ovarian enlargement, hyperstimulation, and multiple-birth pregnancies. This study is designed to determine novel effective strategies to promote normal cycling in this patient population.

Arms: arm 1: Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose. arm 2: The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control
Interventions: intervention 1: doxycycline intervention 2: Sugar Pill
Intervention descriptions: intervention 1: 200mg/day in divided doses of 100mg twice daily intervention 2: 1 pill twice a day

Protocol documents:
Clinical trial NCT01807650
Conditions: Wounds
Keywords: Split-Thickness Skin Graft (STSG) donor site Split-thickness skin graft STSG Wound healing Skin grafting Superficial wound Partial-thickness wound Time to wound closure
Sponsor: Birken AG
Start date: 2013-03-01; Completion date: 2014-09-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this phase III clinical trial was to show safety and efficacy of Oleogel-S10 in accelerating the wound healing of Split-Thickness Skin Graft (STSG) donor sites.

Detailed description:
Oleogel-S10 has shown efficacy and was well tolerated in previous clinical trials in participants with skin lesions. Especially the results in a previous study with STSG donor sites suggested that Oleogel-S10 should be efficacious and safe in the treatment of superficial wounds.

The present phase III clinical trial in STSG donor sites was initiated to demonstrate wound healing progress, i.e., the time to healing and the grade of epithelialization of the wound.

In this study, STSG donor sites were separated into 2 wound halves. Randomly assigned, 1 wound half was treated with Oleogel-S10 and non-adhesive wound dressing, the other wound half with non-adhesive wound dressing only (standard of care).

Wound healing progress was documented by photos which were assessed by expert reviewers blinded to the treatment of the wound halves.

Arms: arm 1: A split-thickness skin graft (STSG) donor site wound \>15cm2 in size was divided in 2 halves. One half was randomized to Oleogel-S10 treatment and non-adhesive wound dressing (intra-individual comparison). Oleogel-S10 was administered (1 cm or 100 mg per cm2 wound area corresponding to thickness of about 1 mm or 0.04 inch) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28. arm 2: A STSG donor site wound \>15cm2 in size was divided in 2 halves. One half was randomized to treatment with non-adhesive wound dressing only (intra-individual comparison). Non-adhesive wound dressings are standard of care (SOC) in the treatment of STSG donor sites. Wound dressings were changed every 3 to 4 days.
Interventions: intervention 1: Oleogel-S10, non-adhesive wound dressing intervention 2: Non-adhesive wound dressing only
Intervention descriptions: intervention 1: 1 cm or 100 mg Oleogel-S10 per cm2 wound area (corresponds to thickness of approximately 1 mm or 0.04 inch) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28 intervention 2: Soft silicone faced polyurethane foam dressing such as Mepilex® only every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28

Protocol documents:
Clinical trial NCT01811472
Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)
Keywords: Multi-center, randomized, double-blind, NAFLD, elevated triglycerides
Sponsor: Novartis Pharmaceuticals
Start date: 2013-06-01; Completion date: 2014-09-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine whether LCQ908 effectively lowers liver fat, as assessed by MRI and to assess its safety and tolerability profile in subjects with non-alcoholic fatty liver disease (NAFLD).

Detailed description:

Arms: arm 1: Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study. arm 2: Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study. arm 3: Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
Interventions: intervention 1: LCQ908 intervention 2: placebo
Intervention descriptions: intervention 1: LCQ908 5 mg, 10 mg, 20 mg tablets intervention 2: Matching placebo of LCQ908 5 mg, 10 mg, 20 mg tablets.

Protocol documents: