TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Monoclonal antibodies such as daclizumab could be a possible alternative immunotherapy to interferon beta treatment in people with multiple sclerosis (MS). It blocks the interleukin-2 receptor alpha subunit (CD25), and seems to be beneficial to patients with relapsing remitting multiple sclerosis (RRMS) in clinical and magnetic resonance imaging (MRI) measures of outcomes.This is an update of a Cochrane review first published in 2010, and previously updated in 2012.
Objectives: To assess the safety of daclizumab and its efficacy to prevent clinical worsening in patients with RRMS.
Selection criteria: All randomised controlled clinical trials (RCTs) evaluating daclizumab, alone or combined with other treatments versus placebo, or any other treatment for patients with RRMS.
Background: Fibromyalgia is characterized by chronic widespread pain that leads to reduced physical function. Exercise training is commonly recommended as a treatment for management of symptoms. We examined the literature on resistance training for individuals with fibromyalgia. Resistance training is exercise performed against a progressive resistance with the intention of improving muscle strength, muscle endurance, muscle power, or a combination of these.
Objectives: To evaluate the benefits and harms of resistance exercise training in adults with fibromyalgia. We compared resistance training versus control and versus other types of exercise training.
Selection criteria: Selection criteria included: a) randomized clinical trial, b) diagnosis of fibromyalgia based on published criteria, c) adult sample, d) full-text publication, and e) inclusion of between-group data comparing resistance training versus a control or other physical activity intervention.
Background: Retinitis pigmentosa (RP) comprises a group of hereditary eye diseases characterized by progressive degeneration of retinal photoreceptors. It results in severe visual loss that may lead to legal blindness. Symptoms may become manifest during childhood or adulthood, and include poor night vision (nyctalopia) and constriction of peripheral vision (visual field loss). This field loss is progressive and usually does not reduce central vision until late in the disease course.The worldwide prevalence of RP is one in 4000, with 100,000 patients affected in the USA. At this time, there is no proven therapy for RP.
Objectives: The objective of this review was to synthesize the best available evidence regarding the effectiveness and safety of vitamin A and fish oils (docosahexaenoic acid (DHA)) in preventing the progression of RP.
Selection criteria: We included randomized controlled trials (RCTs) evaluating the effectiveness of vitamin A, fish oils (DHA) or both, as a treatment for RP. We excluded cluster-randomized trials and cross-over trials.
Background: Peripheral arterial thrombolysis is used in the management of peripheral arterial ischaemia. Streptokinase was originally used but safety concerns led to a search for other agents. Urokinase and recombinant tissue plasminogen activator (rt-PA) have increasingly become established as first line agents for peripheral arterial thrombolysis. Potential advantages of these agents include improved safety, greater efficacy and a more rapid response. Recently drugs such as pro-urokinase, recombinant staphylokinase and alfimperase have been introduced. This is an update of a review first published in 2010.
Objectives: To determine which fibrinolytic agents are most effective in peripheral arterial ischaemia.
Selection criteria: RCTs comparing fibrinolytic agents to treat peripheral arterial occlusion.
Background: Depression is common in primary care and is associated with marked personal, social and economic morbidity, thus creating significant demands on service providers. The antidepressant fluoxetine has been studied in many randomised controlled trials (RCTs) in comparison with other conventional and unconventional antidepressants. However, these studies have produced conflicting findings.Other systematic reviews have considered selective serotonin reuptake inhibitor (SSRIs) as a group which limits the applicability of the indings for fluoxetine alone. Therefore, this review intends to provide specific and clinically useful information regarding the effects of fluoxetine for depression compared with tricyclics (TCAs), SSRIs, serotonin-noradrenaline reuptake inhibitors (SNRIs), monoamineoxidase inhibitors (MAOIs) and newer agents, and other conventional and unconventional agents.
Objectives: To assess the effects of fluoxetine in comparison with all other antidepressive agents for depression in adult individuals with unipolar major depressive disorder.
Selection criteria: All RCTs comparing fluoxetine with any other AD (including non-conventional agents such as hypericum) for patients with unipolar major depressive disorder (regardless of the diagnostic criteria used) were included. For trials that had a cross-over design only results from the first randomisation period were considered.
Background: This is an updated version of the original Cochrane review published in Issue 4, 2010 (Law 2010). Cluster headache is an uncommon,severely painful, and disabling condition, with rapid onset. Validated treatment options are limited; first-line therapy includes inhaled oxygen. Other therapies such as intranasal lignocaine and ergotamine are not as commonly used and are less well studied. Triptans are successfully used to treat migraine attacks and they may also be useful for cluster headache.
Objectives: To assess the efficacy and tolerability of the triptan class of drugs compared to placebo and other active interventions in the acute treatment of episodic and chronic cluster headache in adult patients.
Selection criteria: Randomised, double-blind, placebo-controlled studies of triptans for acute treatment of cluster headache episodes.
Background: Combination chemotherapy can cause greater tumour cell kill if the drug dose is not compromised, while sequential single agent chemotherapy may allow for greater dose intensity and treatment time, potentially meaning greater benefit from each single agent. In addition, sequentially using single agents might cause less toxicity and impairment of quality of life, but it is not known whether this might compromise survival time.
Objectives: To assess the effect of combination chemotherapy compared to the same drugs given sequentially in women with metastatic breast cancer.
Selection criteria: Randomised controlled trials of combination chemotherapy compared to the same drugs used sequentially in women with metastatic breast cancer in the first-, second- or third-line setting.
Background: Bipolar disorder is a mental disorder characterised by episodes of elevated or irritable mood (manic or hypomanic episodes) and episodes of low mood and loss of energy (depressive episodes). Drug treatment is the first-line treatment for acute mania with the initial aim of rapid control of agitation, aggression and dangerous behaviour. Aripiprazole, an atypical antipsychotic, is used in the treatment of mania both as monotherapy and combined with other medicines. The British Association of Psychopharmacology guidelines report that, in monotherapy placebo-controlled trials, the atypical antipsychotics, including aripiprazole, have been shown to be effective for acute manic or mixed episodes.
Objectives: To assess the efficacy and tolerability of aripiprazole alone or in combination with other antimanic drug treatments, compared with placebo and other drug treatments, in alleviating acute symptoms of manic or mixed episodes. Other objectives include reviewing the acceptability of treatment with aripiprazole, investigating the adverse effects of aripiprazole treatment, and determining overall mortality rates among those receiving aripiprazole treatment.
Selection criteria: Randomised trials comparing aripiprazole versus placebo or other drugs in the treatment of acute manic or mixed episodes.
Background: Major depressive disorder (MDD), or depression, is a syndrome characterised by a number of behavioural, cognitive and emotional features. It is most commonly associated with a sad or depressed mood, a reduced capacity to feel pleasure, feelings of hopelessness, loss of energy, altered sleep patterns, weight fluctuations, difficulty in concentrating and suicidal ideation. There is a need for more effective and better tolerated antidepressants to combat this condition. Agomelatine was recently added to the list of available antidepressant drugs; it is a novel antidepressant that works on melatonergic (MT1 and MT2), 5-HT 2B and 5-HT2C receptors. Because the mechanism of action is claimed to be novel, it may provide a useful, alternative pharmacological strategy to existing antidepressant drugs.
Objectives: The objective of this review was 1) to determine the efficacy of agomelatine in alleviating acute symptoms of major depressive disorder in comparison with other antidepressants, 2) to review the acceptability of agomelatine in comparison with other antidepressant drugs, and, 3) to investigate the adverse effects of agomelatine, including the general prevalence of side effects in adults.
Selection criteria: Randomised controlled trials allocating adult participants with major depression to agomelatine versus any other antidepressive agent.
Background: Children and adolescents with femoral fractures are almost always admitted to hospital. They invariably start their hospital experience in the Emergency Department, often requiring transfer to a specialist children's hospital. They require analgesia or anaesthesia so that radiographs can be obtained and for management of their fractures. The initial care process involves from two to six transfers from stretcher to stretcher/imaging/operating-suite table or hospital bed within the first few hours, so prompt pain relief is essential. Systemic analgesia can be provided orally or parenterally. Alternatively, a nerve block may be used where local anaesthetic is injected around a nerve to block sensation or freeze the involved area.
Objectives: To assess the effects (benefits and harms) of femoral nerve block (FNB) or fascia iliaca compartment block (FICB) for initial pain management of children with fractures of the femur (thigh bone) in the pre-hospital or in-hospital emergency setting, with or without systemic analgesia.
Selection criteria: Randomised and quasi-randomised controlled trials assessing the effects of FNB or FICB for initial pain management compared with systemic opiates in children (aged under 18 years) with fractures of the femur receiving pre-hospital or in hospital emergency care. Primary outcomes included failure of analgesia at 30 minutes, pain levels during procedures and transfers (e.g. to a stretcher or hospital ward) for up to eight hours, and adverse effects.
Background: Asthma is characterised by chronic inflammation of the airways and recurrent exacerbations with wheezing, chest tightness and cough. Treatment with inhaled steroids and bronchodilators often results in good control of symptoms, prevention of further morbidity and mortality and improved quality of life. Several steroids and beta2-agonists (long- and short-acting) as well as combinations of these treatments are available in a single inhaler to be used once or twice a day, with a separate inhaler for relief of symptoms when needed (for patients in Step three or higher, according to Global Initiative for Asthma (GINA) guidelines). Budesonide/formoterol is also licenced for use as maintenance and reliever therapy from a single inhaler (SiT; sometimes referred to as SMART therapy). SiT can be prescribed at a lower dose than other combination therapy because of the additional steroid doses being received as reliever therapy. It has been suggested that using SiT improves compliance and hence reduces symptoms and exacerbations, but it is unclear whether it increases side effects associated with the use of inhaled steroids.
Objectives: To assess the efficacy and safety of budesonide/formoterol in a single inhaler (SiT) to be used for both maintenance and reliever therapy in asthma in comparison with maintenance treatment provided through combination inhalers with a higher maintenance steroid dose (either fluticasone/salmeterol or budesonide/formoterol), along with additional fast-acting beta2-agonists for relief of symptoms.
Selection criteria: We included parallel-group, randomised controlled trials of at least 12 weeks' duration. Studies were included if they compared single-inhaler therapy with budesonide/formoterol (SiT) versus combination inhalers at a higher maintenance dose of steroids than was given in the SiT arm (either salmeterol/fluticasone or budesonide/formoterol).
Background: Hyperbaric oxygen therapy (HBOT) is used as a treatment for acute wounds (such as those arising from surgery and trauma). However, the effects of HBOT on wound healing are unclear.
Objectives: To determine the effects of HBOT on the healing of acute surgical and traumatic wounds.
Selection criteria: Randomised controlled trials (RCTs) comparing HBOT with other interventions such as dressings, steroids, or sham HOBT or comparisons between alternative HBOT regimens.
Background: Work-related upper limb disorder (WRULD), repetitive strain injury (RSI), occupational overuse syndrome (OOS) and work-related complaints of the arm, neck or shoulder (CANS) are the most frequently used umbrella terms for disorders that develop as a result of repetitive movements, awkward postures and impact of external forces such as those associated with operating vibrating tools. Work-related CANS, which is the term we use in this review, severely hampers the working population.
Objectives: To assess the effects of conservative interventions for work-related complaints of the arm, neck or shoulder (CANS) in adults on pain, function and work-related outcomes.
Selection criteria: We included randomised controlled trials (RCTs) and quasi-randomised controlled trials evaluating conservative interventions for work-related complaints of the arm, neck or shoulder in adults. We excluded trials undertaken to test injections and surgery. We included studies that evaluated effects on pain, functional status or work ability.
Background: Between 10% to 18% of people undergoing cholecystectomy for gallstones have common bile duct stones. Treatment of the bile duct stones can be conducted as open cholecystectomy plus open common bile duct exploration or laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC + LCBDE) versus pre- or post-cholecystectomy endoscopic retrograde cholangiopancreatography (ERCP) in two stages, usually combined with either sphincterotomy (commonest) or sphincteroplasty (papillary dilatation) for common bile duct clearance. The benefits and harms of the different approaches are not known.
Objectives: We aimed to systematically review the benefits and harms of different approaches to the management of common bile duct stones.
Selection criteria: We included all randomised clinical trials which compared the results from open surgery versus endoscopic clearance and laparoscopic surgery versus endoscopic clearance for common bile duct stones.
Background: Both paracetamol and ibuprofen are commonly used analgesics for the relief of pain following the surgical removal of lower wisdom teeth (third molars). In 2010, a novel analgesic (marketed as Nuromol) containing both paracetamol and ibuprofen in the same tablet was launched in the United Kingdom, this drug has shown promising results to date and we have chosen to also compare the combined drug with the single drugs using this model. In this review we investigated the optimal doses of both paracetamol and ibuprofen via comparison of both and via comparison with the novel combined drug. We have taken into account the side effect profile of the study drugs. This review will help oral surgeons to decide on which analgesic to prescribe following wisdom tooth removal.
Objectives: To compare the beneficial and harmful effects of paracetamol, ibuprofen and the novel combination of both in a single tablet for pain relief following the surgical removal of lower wisdom teeth, at different doses and administered postoperatively.
Selection criteria: Only randomised controlled double-blinded clinical trials were included. Cross-over studies were included provided there was a wash out period of at least 14 days. There had to be a direct comparison in the trial of two or more of the trial drugs at any dosage. All trials used the third molar pain model.
Background: The optimal duration for Helicobacter pylori (H. pylori) eradication therapy is controversial, with recommendations ranging from 7 to 14 days. Several systematic reviews have attempted to address this issue but have given conflicting results and limited their analysis to proton pump inhibitor (PPI), two antibiotics (PPI triple) therapy. We performed a systematic review and meta-analysis to investigate the optimal duration of multiple H. pylori eradication regimens.
Objectives: The primary objective was to assess the relative effectiveness of different durations (7, 10 or 14 days) of a variety of regimens for eradicating H. pylori. The primary outcome was H. pylori persistence. The secondary outcome was adverse events.
Selection criteria: Only parallel group RCTs assessing the efficacy of one to two weeks duration of first line H. pylori eradication regimens in adults were eligible. Within each regimen, the same combinations of drugs at the same dose were compared over different durations. Studies with at least two arms comparing 7, 10, or 14 days were eligible. Enrolled participants needed to be diagnosed with at least one positive test for H. pylori on the basis of a rapid urease test (RUT), histology, culture, urea breath test (UBT), or a stool antigen test (HpSA) before treatment. Eligible trials needed to confirm eradication of H. pylori as their primary outcome at least 28 days after completion of eradication treatment. Trials using only serology or a polymerase chain reaction (PCR) to determine H. pylori infection or eradication were excluded.
Background: Telerehabilitation is an alternative way of delivering rehabilitation services. Information and communication technologies are used to facilitate communication between the healthcare professional and the patient in a remote location. The use of telerehabilitation is becoming more viable as the speed and sophistication of communication technologies improve. However, it is currently unclear how effective this model of delivery is relative to rehabilitation delivered face-to-face.
Objectives: To determine whether the use of telerehabilitation leads to improved ability to perform activities of daily living amongst stroke survivors when compared with (1) in-person rehabilitation (when the clinician and the patient are at the same physical location and rehabilitation is provided face-to-face); or (2) no rehabilitation. Secondary objectives were to determine whether use of telerehabilitation leads to greater independence in self care and domestic life and improved mobility, health-related quality of life, upper limb function, cognitive function or functional communication when compared with in-person rehabilitation and no rehabilitation. Additionally, we aimed to report on the presence of adverse events, cost-effectiveness, feasibility and levels of user satisfaction associated with telerehabilitation interventions.
Selection criteria: Randomised controlled trials (RCTs) of telerehabilitation in stroke. We included studies that compared telerehabilitation with in-person rehabilitation or no rehabilitation. In addition, we synthesised and described the results of RCTs that compared two different methods of delivering telerehabilitation services without an alternative group. We included rehabilitation programmes that used a combination of telerehabilitation and in-person rehabilitation provided that the greater proportion of intervention was provided via telerehabilitation.
Background: Post-traumatic stress disorder (PTSD) is a distressing condition, which is often treated with psychological therapies. Earlier versions of this review, and other meta-analyses, have found these to be effective, with trauma-focused treatments being more effective than non-trauma-focused treatments. This is an update of a Cochrane review first published in 2005 and updated in 2007.
Objectives: To assess the effects of psychological therapies for the treatment of adults with chronic post-traumatic stress disorder (PTSD).
Selection criteria: Randomised controlled trials of individual trauma-focused cognitive behavioural therapy (TFCBT), eye movement desensitisation and reprocessing (EMDR), non-trauma-focused CBT (non-TFCBT), other therapies (supportive therapy, non-directive counselling, psychodynamic therapy and present-centred therapy), group TFCBT, or group non-TFCBT, compared to one another or to a waitlist or usual care group for the treatment of chronic PTSD. The primary outcome measure was the severity of clinician-rated traumatic-stress symptoms.
Background: In individuals with cystic fibrosis there are no established targets for participation in physical activity, nor have any ideal strategies to promote participation in physical activity been identified
Objectives: To evaluate the effect of treatment to increase participation in physical activity in people with cystic fibrosis.
Selection criteria: All randomised and quasi-randomised controlled studies which investigated strategies designed to promote increased participation in daily physical activity for individuals with cystic fibrosis.
Background: Acute otitis media (AOM) is a common problem in children, for which amoxicillin, with or without clavulanate, is frequently prescribed as a treatment of choice. The conventional recommendation is either three or four daily doses. However, nowadays it is frequently prescribed as once or twice daily doses. If once or twice daily amoxicillin, with or without clavulanate, is as effective for acute otitis media as three or four times a day, it may be more convenient to give the medication once or twice a day to children and hence improve compliance.
Objectives: To compare the effectiveness of one or two daily doses with three or four daily doses of amoxicillin, with or without clavulanate, for the treatment of AOM in children; and to compare complication rates and adverse reactions.
Selection criteria: We included randomised controlled trials (RCTs) of children aged 12 years or younger with AOM, diagnosed by acute ear pain (otalgia) and inflamed ear drum (confirmed by positive tympanocentesis or tympanogram of type B or C).