TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: The long-acting bronchodilator tiotropium and single inhaler combination therapy of inhaled corticosteroids and long-acting beta(2)-agonists are both commonly used for maintenance treatment of chronic obstructive pulmonary disease. Combining these treatments, which have different mechanisms of action, may be more effective than the individual components. However, the benefits and risks of using tiotropium and combination therapy together for the treatment of chronic obstructive pulmonary disease are unclear.
Objectives: To assess the relative effects of inhaled corticosteroid and long-acting beta(2)-agonist combination therapy in addition to tiotropium compared to tiotropium or combination therapy alone in patients with chronic obstructive pulmonary disease.
Selection criteria: We included parallel, randomised controlled trials of three months or longer, comparing inhaled corticosteroid and long-acting beta(2)-agonists combination therapy in addition to inhaled tiotropium against tiotropium alone or combination therapy alone.
Background: This review updates parts of two earlier Cochrane reviews investigating effects of gabapentin in chronic neuropathic pain (pain due to nerve damage). Antiepileptic drugs are used to manage pain, predominantly for chronic neuropathic pain, especially when the pain is lancinating or burning.
Objectives: To evaluate the analgesic effectiveness and adverse effects of gabapentin for chronic neuropathic pain management.
Selection criteria: Randomised, double-blind studies reporting the analgesic and adverse effects of gabapentin in neuropathic pain with assessment of pain intensity and/or pain relief, using validated scales. Participants were adults aged 18 and over.
Background: Malignant germ cell tumour of the ovary occurs in up to 0.07% of woman globally. Due to its rarity, evidence for treatment is lacking and often extrapolates clinical trial results of testicular germ cell cancers. The investigation on this rare tumour is further compounded by the fact that its occurrence in the adult population is even less compared to their paediatric counterpart. At present, the effectiveness of chemotherapy, regardless of stage in malignant germ cell tumour of the ovary is not entirely clear.
Objectives: To evaluate the effectiveness and safety of chemotherapy in adult women with early stage, advanced and recurrent malignant germ cell ovarian cancers.
Selection criteria: We searched for randomised controlled trials (RCTs), quasi-RCTs and non-randomised studies that compared systemic therapy in adult women diagnosed with germ cell ovarian cancer who have confirmed pathological diagnoses.
Background: Mefenamic acid is a non-steroidal anti-inflammatory drug (NSAID). It is most often used for treating pain of dysmenorrhoea in the short term (seven days or less), as well as mild to moderate pain including headache, dental pain, postoperative and postpartum pain. It is widely available in many countries worldwide.
Objectives: To assess the efficacy of single dose oral mefenamic acid in acute postoperative pain, and any associated adverse events.
Selection criteria: Single oral dose, randomised, double-blind, placebo-controlled trials of mefenamic acid for relief of established moderate to severe postoperative pain in adults.
Background: Pancreatic cancer causes severe pain in 50 to 70% of patients and is often difficult to treat. Celiac plexus block (CPB) is thought to be a safe and effective technique for reducing the severity of pain.
Objectives: To determine the efficacy and safety of celiac plexus neurolysis in reducing pancreatic cancer pain, and to identify adverse effects and differences in efficacy between the different techniques.
Selection criteria: Randomised controlled trials (RCTs) of CPB by the percutaneous approach or endoscopic ultrasonography (EUS)-guided neurolysis in adults with pancreatic cancer at any stage, with a minimum of four weeks follow-up.
Background: Standard treatment for high grade glioma (HGG) usually entails surgery (either biopsy or resection) followed by radiotherapy plus or minus temozolomide. Implanting wafers impregnated with chemotherapy agents into the resection cavity represents a novel means of delivering drugs directly to the resection cavity with potentially fewer systemic side effects. It is not clear how effective this modality is or whether it should be recommended as part of standard care for patients with HGG.
Objectives: To estimate the clinical effectiveness of chemotherapy wafers for patients with HGG.
Selection criteria: Patients included those of all ages with a histologically proven diagnosis of HGG (using intra-operative analysis when undergoing first resection). Therapy could be instigated for either newly diagnosed disease (primary therapy) or at recurrence. Interventions included insertion of chemotherapy wafers to the resection cavity. Included studies had to be randomised controlled trials (RCTs).
Background: Residents of nursing care homes for older people are highly likely to die there, making these places where palliative care is needed.
Objectives: The primary objective was to determine effectiveness of multi-component palliative care service delivery interventions for residents of care homes for older people. The secondary objective was to describe the range and quality of outcome measures.
Selection criteria: We planned to include Randomised Clinical Trials (RCTs), Controlled Clinical Trials (CCTs), controlled before-and-after studies and interrupted time series studies of multi-component palliative care service delivery interventions for residents of care homes for older people. These usually include the assessment and management of physical, psychological and spiritual symptoms and advance care planning. We did not include individual components of palliative care, such as advance care planning.
Background: The success of evidence-based practice depends on the clear and effective communication of statistical information.
Objectives: To evaluate the effects of using alternative statistical presentations of the same risks and risk reductions on understanding, perception, persuasiveness and behaviour of health professionals, policy makers, and consumers.
Selection criteria: We included randomized and non-randomized controlled parallel and cross-over studies. We focused on four comparisons: a comparison of statistical presentations of a risk (eg frequencies versus probabilities) and three comparisons of statistical presentation of risk reduction: relative risk reduction (RRR) versus absolute risk reduction (ARR), RRR versus number needed to treat (NNT), and ARR versus NNT.
Background: Convergence insufficiency is a common eye muscle co-ordination problem in which the eyes have a strong tendency to drift outward (exophoria) when reading or doing close work. Symptoms may include eye strain, headaches, double vision, print moving on the page, frequent loss of place when reading, inability to concentrate, and short attention span.
Objectives: To systematically assess and synthesize evidence from randomized controlled trials (RCTs) on the effectiveness of non-surgical interventions for convergence insufficiency.
Selection criteria: We included RCTs examining any form of non-surgical intervention against placebo, no treatment, sham treatment, or each other.
Background: According to clinical guidelines, dopamine agonists are the first-line treatment of restless legs syndrome (RLS).
Objectives: To evaluate efficacy and safety of dopamine agonists for RLS.
Selection criteria: We included double-blind randomised controlled trials (RCTs) of dopamine agonist treatment versus placebo or other treatment for a period of at least seven days in patients with RLS (≥ 18 years). Outcomes included the International RLS Severity Rating Scale (IRLS), Clinical Global Impressions (CGI-I), polysomnography and self rated sleep quality, quality of life, daytime functioning, and safety parameters.
Background: Selective type 1 cannabinoid (CB1) receptor antagonists may assist with smoking cessation by restoring the balance of the endocannabinoid system, which can be disrupted by prolonged use of nicotine. They also seeks to address many smokers' reluctance to persist with a quit attempt because of concerns about weight gain.
Objectives: To determine whether selective CB1 receptor antagonists (currently rimonabant and taranabant) increase the numbers of people stopping smoking To assess their effects on weight change in successful quitters and in those who try to quit but fail.
Selection criteria: Types of studies Randomized controlled trialsTypes of participants Adult smokersTypes of interventions Selective CB1 receptor antagonists, such as rimonabant and taranabant. Types of outcome measures The primary outcome is smoking status at a minimum of six months after the start of treatment. We preferred sustained cessation rates to point prevalence, and biochemically verified cessation to self-reported quitting. We regarded smokers who drop out or are lost to follow up as continuing smokers. We have noted any adverse effects of treatment.A secondary outcome is weight change associated with the cessation attempt.
Background: Concerns regarding the safety of transfused blood have generated considerable enthusiasm for the use of technologies intended to reduce the use of allogeneic blood (blood from an unrelated donor). Platelet-rich plasmapheresis (PRP) offers an alternative approach to blood conservation.
Objectives: To examine the evidence for the efficacy of PRP in reducing peri-operative allogeneic red blood cell (RBC) transfusion, and the evidence for any effect on clinical outcomes such as mortality and re-operation rates.
Selection criteria: Controlled parallel group trials in which adult patients, scheduled for non-urgent surgery, were randomised to PRP, or to a control group which did not receive the intervention.
Background: Surgery is sometimes recommended for persistent lateral elbow pain where other less invasive interventions have failed.
Objectives: To determine the benefits and safety of surgery for lateral elbow pain.
Selection criteria: Randomised and controlled clinical trials assessing a surgical intervention compared with no treatment or another intervention including an alternate surgical intervention, in adults with lateral elbow pain.
Background: Parenting programmes are a potentially important means of supporting teenage parents and improving outcomes for their children, and parenting support is a priority across most Western countries. This review updates the previous version published in 2001.
Objectives: To examine the effectiveness of parenting programmes in improving psychosocial outcomes for teenage parents and developmental outcomes in their children.
Selection criteria: Randomised controlled trials assessing short-term parenting interventions aimed specifically at teenage parents and a control group (no-treatment, waiting list or treatment-as-usual).
Background: This is an update of a Cochrane Review first published in The Cochrane Library in Issue 4, 2001 and previously updated in 2003.Tonsillectomy is a commonly performed surgical procedure. There are several operative methods currently in use, but the superiority of one over another has not been clearly demonstrated.
Objectives: To compare the morbidity associated with tonsillectomy by two different techniques - dissection and diathermy.
Selection criteria: Randomised controlled trials of children and adults undergoing tonsillectomy or adenotonsillectomy by dissection or diathermy techniques.
Background: Concerns regarding the safety of transfused blood have led to the development of a range of interventions to minimise blood loss during major surgery. Anti-fibrinolytic drugs are widely used, particularly in cardiac surgery, and previous reviews have found them to be effective in reducing blood loss, the need for transfusion, and the need for re-operation due to continued or recurrent bleeding. In the last few years questions have been raised regarding the comparative performance of the drugs. The safety of the most popular agent, aprotinin, has been challenged, and it was withdrawn from world markets in May 2008 because of concerns that it increased the risk of cardiovascular complications and death.
Objectives: To assess the comparative effects of the anti-fibrinolytic drugs aprotinin, tranexamic acid (TXA), and epsilon aminocaproic acid (EACA) on blood loss during surgery, the need for red blood cell (RBC) transfusion, and adverse events, particularly vascular occlusion, renal dysfunction, and death.
Selection criteria: Randomised controlled trials (RCTs) of anti-fibrinolytic drugs in adults scheduled for non-urgent surgery. Eligible trials compared anti-fibrinolytic drugs with placebo (or no treatment), or with each other.
Background: There is a wide geographical variation in the prevalence of asthma and observational studies have suggested that dietary sodium may play a role.
Objectives: To assess the effect of dietary sodium manipulation on asthma control.
Selection criteria: We considered only RCTs that involved dietary sodium reduction or increased sodium intake in patients with asthma.
Background: Biologics are used for the treatment of rheumatoid arthritis and many other conditions. While the efficacy of biologics has been established, there is uncertainty regarding the adverse effects of this treatment. Since serious risks such as tuberculosis (TB) reactivation, serious infections, and lymphomas may be common to the biologics but occur in small numbers across the various indications, we planned to combine the results from biologics used in many conditions to obtain the much needed risk estimates.
Objectives: To compare the adverse effects of tumor necrosis factor blocker (etanercept, adalimumab, infliximab, golimumab, certolizumab), interleukin (IL)-1 antagonist (anakinra), IL-6 antagonist (tocilizumab), anti-CD28 (abatacept), and anti-B cell (rituximab) therapy in patients with any disease condition except human immunodeficiency disease (HIV/AIDS).
Background: Fenoprofen is a non-steroidal anti-inflammatory drug (NSAID), available in several different countries, but not widely used.
Objectives: To assess the efficacy of single dose oral fenoprofen in acute postoperative pain, and associated adverse events.
Selection criteria: Single oral dose, randomised, double-blind, placebo-controlled trials of fenoprofen for relief of established moderate to severe postoperative pain in adults.
Background: Physical restraints (PR) are commonly used in geriatric long-term care. Restraint-free care should be the aim of high quality nursing care.
Objectives: To evaluate the effectiveness of interventions to prevent and reduce the use of physical restraints in older people who require long-term nursing care (either in community nursing care or in residential care facilities).
Selection criteria: Individual or cluster-randomised controlled trials comparing an intervention aimed at reducing the use of physical restraints with usual care in long-term geriatric care settings.
Background: To prevent the development of drug resistance, the World Health Organization (WHO) recommends treating malaria with combination therapy. Azithromycin, an antibiotic with antimalarial properties, may be a useful additional option for antimalarial therapy.
Objectives: To compare the use of azithromycin alone or in combination with other antimalarial drugs with the use of alternative antimalarial drugs for treating uncomplicated malaria caused by Plasmodium falciparum or Plasmodium vivax.
Selection criteria: Randomized controlled trials comparing azithromycin, either alone or combined with another antimalarial drug, with another antimalarial drug used alone or combined with another antimalarial drug, or with azithromycin combined with another antimalarial drug if different combinations or doses of azithromycin were used. The primary outcome was treatment failure by day 28, defined as parasitological or clinical evidence of treatment failure between the start of treatment and day 28. Secondary outcomes included treatment failure by day 28 corrected for new infections confirmed by polymerase chain reaction (PCR), fever and parasite clearance time, and adverse events.
Background: This is an update of the original Cochrane review published in Issue 2, 2007. Some antiepileptic medicines have a place in the treatment of neuropathic pain (pain due to nerve damage). This updated review adds five new additional studies looking at evidence for Lamotrigine as an effective treatment for acute and chronic pain.
Objectives: To assess analgesic efficacy and adverse effects of the antiepileptic drug lamotrigine in acute and chronic pain.
Selection criteria: RCTs investigating the use of lamotrigine (any dose, by any route, and for any study duration) for the treatment of acute or chronic pain. Assessment of pain intensity or pain relief, or both, using validated scales. Participants were adults aged 18 and over. Only full journal publication articles were included.
Background: Levodopa plus dopamine decarboxylase inhibitor is a common treatment for restless legs syndrome (RLS).
Objectives: To evaluate efficacy and safety of levodopa for RLS compared to placebo and other active agents.
Selection criteria: We included double-blind randomised controlled trials (RCT) investigating levodopa treatment versus placebo or other treatment for at least seven days in patients with RLS (age ≥ 18 years). Outcomes included symptom severity, CGI-I, objective as well as self rated sleep parameters, quality of life, and safety parameters.
Background: Several systematic reviews compared recombinant gonadotrophin with urinary gonadotrophins (HMG, purified FSH, highly purified FSH) for ovarian hyperstimulation in IVF and ICSI cycles and these reported conflicting results. Each of these reviews used different inclusion and exclusion criteria for trials. Our aim in producing this review is to bring together all randomised studies in this field under common inclusion criteria with consistent and valid statistical methods.
Objectives: To compare the effectiveness of recombinant gonadotrophin (rFSH) with the three main types of urinary gonadotrophins (i.e. HMG, FSH-P and FSH-HP) for ovarian stimulation in women undergoing IVF or ICSI treatment cycles.
Selection criteria: All randomised controlled trials reporting data comparing clinical outcomes for women undergoing IVF/ICSI cycles and using recombinant FSH in comparison with HMG or highly purified HMG, purified urinary FSH (FSH-P), and highly purified urinary FSH (FSH-HP) for ovarian hyperstimulation in IVF or ICSI cycles were included.
Background: Cisplatin and several related antineoplastic agents used to treat many types of solid tumors are neurotoxic, and most patients completing a full course of cisplatin chemotherapy develop a clinically detectable sensory neuropathy. Effective neuroprotective therapies have been sought.
Objectives: To examine the efficacy of purported chemoprotective agents to prevent or limit the neurotoxicity of cisplatin and related agents.
Selection criteria: Quasi-randomized or randomized controlled trials whose participants received cisplatin (or related compounds) chemotherapy with or without a potential chemoprotectant (acetylcysteine, amifostine, ACTH, BNP7787, calcium and magnesium, diethyldithiocarbamate, glutathione, Org 2766, oxcarbazepine, or vitamin E) and were evaluated zero to six months after completing chemotherapy using quantitative sensory testing (primary) or other measures including nerve conduction studies or neurological impairment rating using validated scales (secondary).
Background: There is controversy as to whether compulsory community treatment for people with severe mental illnesses reduces health service use, or improves clinical outcome and social functioning. Given the widespread use of such powers it is important to assess the effects of this type of legislation.
Objectives: To examine the clinical and cost effectiveness of compulsory community treatment for people with severe mental illness.
Selection criteria: All relevant randomised controlled clinical trials of compulsory community treatment compared with standard care for people with severe mental illness.
Background: Purified thymus extracts (pTE) and synthetic thymic peptides (sTP) are thought to enhance the immune system of cancer patients in order to fight the growth of tumour cells and to resist infections due to immunosuppression induced by the disease and antineoplastic therapy.
Objectives: To evaluate the effectiveness of pTE and sTP for the management of cancer.
Selection criteria: Randomised trials of pTE or sTP in addition to chemotherapy or radiotherapy, or both, compared to the same regimen with placebo or no additional treatment in adult cancer patients.
Background: Injury in the home is common, accounting for approximately a third of all injuries. The majority of injuries to children under five and people aged 75 and older occur at home. Multifactorial injury prevention interventions have been shown to reduce injuries in the home. However, few studies have focused specifically on the impact of physical adaptations to the home environment and the effectiveness of such interventions needs to be ascertained.
Objectives: To determine the effect of modifications to the home environment on the reduction of injuries due to environmental hazards.
Selection criteria: Randomised controlled trials.
Background: Cleft lip and cleft palate are common birth defects, affecting about one baby of every 700 born. Feeding these babies is an immediate concern and there is evidence of delay in growth of children with a cleft as compared to those without clefting. In an effort to combat reduced weight for height, a variety of advice and devices are recommended to aid feeding of babies with clefts.
Objectives: This review aims to assess the effects of these feeding interventions in babies with cleft lip and/or palate on growth, development and parental satisfaction.
Selection criteria: Studies were included if they were randomised controlled trials (RCTs) of feeding interventions for babies born with cleft lip, cleft palate or cleft lip and palate up to the age of 6 months (from term).
Background: Lambert-Eaton myasthenic syndrome (LEMS) is an autoimmune disorder of neuromuscular transmission. Treatments attempt to overcome the harmful autoimmune process, or improve residual neuromuscular transmission
Objectives: The objective was to examine the efficacy of treatment in Lambert-Eaton myasthenic syndrome.
Selection criteria: All randomised or quasi-randomised trials of adults and children with a diagnosis of Lambert-Eaton myasthenic syndrome, with or without small-cell lung cancer, receiving any form of pharmacological or physical treatment.
Background: Publication of complete trial results is essential if people are to be able to make well-informed decisions about health care. Selective reporting of randomised controlled trials (RCTs) is a common problem.
Objectives: To systematically review studies of cohorts of RCTs to compare the content of trial reports with the information contained in their protocols, or entries in a trial registry.
Selection criteria: Published or unpublished cohort studies comparing the content of protocols or trial registry entries with published trial reports.
Background: Water-based exercises are used in rehabilitation and might help to reduce disability after stroke.
Objectives: To investigate the effect of water-based exercises for reducing disability after stroke.
Selection criteria: We included studies using random assignment.