TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: A number of potentially modifiable risk factors are known to be associated with poor pregnancy outcomes. These include smoking, drinking excess alcohol, and poor nutrition. Routine health promotion (encompassing education, advice and general health assessment) in the pre-pregnancy period has been proposed for improving pregnancy outcomes by encouraging behavioural change, or allowing early identification of risk factors. While results from observational studies have been encouraging, this review examines evidence from randomised controlled trials of preconception health promotion.
Objectives: To assess the effectiveness of routine pre-pregnancy health promotion for improving pregnancy outcomes when compared with no pre-pregnancy care or usual care.
Selection criteria: Randomised and quasi-randomised trials examining health promotion interventions which aim to identify and modify risk factors before pregnancy. The review focuses on all women of childbearing age rather than those in high-risk groups. We have excluded trials where interventions are aimed specifically at women with established medical, obstetric or genetic risks or already receiving treatment as part of programmes for high-risk groups.
Background: Lornoxicam is one of the oxicam class of non-steroidal anti-inflammatory drugs (NSAIDs), producing analgesic and antipyretic effects in part through the non-selective inhibition of cyclo-oxygenase-1 and -2. It is prescribed for osteoarthritis, rheumatoid arthritis, acute lumbar-sciatica conditions and for postoperative pain management. Lornoxicam is available in 31 countries in Europe, the Middle East, Far East and South America, and is becoming more widely available.
Objectives: To assess the efficacy, the time to onset of analgesia, the time to use of rescue medication and any associated adverse events of single dose oral lornoxicam in acute postoperative pain.
Selection criteria: Single oral dose, randomised, double-blind, placebo-controlled trials of lornoxicam for relief of established moderate to severe postoperative pain in adults.
Background: Topical creams with capsaicin are used to treat pain from a wide range of chronic conditions including neuropathic pain. Following application to the skin capsaicin causes enhanced sensitivity to noxious stimuli, followed by a period with reduced sensitivity and, after repeated applications, persistent desensitisation. There is uncertainty about the efficacy and tolerability of capsaicin for treating painful chronic neuropathies.
Objectives: To review the evidence from controlled trials on the efficacy and tolerability of topically applied capsaicin in chronic neuropathic pain in adults.
Selection criteria: Randomised, double blind, placebo controlled studies of at least six weeks' duration, using topical capsaicin to treat neuropathic pain.
Background: Ketoprofen is a non-selective non-steroidal anti-inflammatory drug (NSAID) used to treat acute and chronic painful conditions. Dexketoprofen is the (S)-enantiomer, which is believed to confer analgesia. Theoretically dexketoprofen is expected to provide equivalent analgesia to ketoprofen at half the dose, with a consequent reduction in gastrointestinal adverse events.
Objectives: To assess efficacy, duration of action, and associated adverse events of single dose oral ketoprofen and dexketoprofen in acute postoperative pain in adults.
Selection criteria: Randomised, double blind, placebo-controlled trials of single dose orally administered ketoprofen and dexketoprofen in adults with moderate to severe acute postoperative pain.
Background: Alcoholic hepatitis is a life-threatening disease, with an average mortality of approximately 40%. There is no widely accepted, effective treatment for alcoholic hepatitis. Pentoxifylline is used to treat alcoholic hepatitis, but there has been no systematic review to assess its effects.
Objectives: To assess the benefits and harms of pentoxifylline in alcoholic hepatitis.
Selection criteria: All randomised clinical trials of pentoxifylline in participants with alcoholic hepatitis compared to control were selected for inclusion.
Background: Osteoarthritis is the most common form of joint disease and the leading cause of pain and disability in the elderly. S-Adenosylmethionine may be a viable treatment option but the evidence about its effectiveness and safety is equivocal.
Objectives: We set out to compare S-Adenosylmethionine (SAMe) with placebo or no specific intervention in terms of effects on pain and function and safety outcomes in patients with knee or hip osteoarthritis.
Selection criteria: Randomised or quasi-randomised controlled trials that compared SAMe at any dosage and in any formulation with placebo or no intervention in patients with osteoarthritis of the knee or hip.
Background: Abatacept inhibits the co-stimulation of T cells and disrupts the inflammatory chain of events that leads to joint inflammation, pain, and damage in rheumatoid arthritis.
Objectives: To assess the efficacy and safety of abatacept in reducing disease activity, pain, and improving function in people with rheumatoid arthritis.
Selection criteria: Randomized controlled trials comparing abatacept alone, or in combination with disease-modifying anti-rheumatic drugs (DMARDs) or biologics, to placebo or other DMARDs or biologics in patients with moderate to severe rheumatoid arthritis.
Background: For the treatment of HIV/AIDS, individuals may consult traditional healers because they possess a shared sociocultural background, meet the needs and expectations of the patients, and pay special attention to social and spiritual matters. Various intervention strategies have been adopted to educate traditional healers in various aspects of Western medicine, with a particular focus on HIV/AIDS.
Objectives: To evaluate the effectiveness of interventions for educating traditional healers in the fundamentals of sexually transmitted infection (STI) and HIV medicine.
Selection criteria: All intervention studies using a controlled design that have evaluated the effect of educational interventions on any one of the outcome measures specified were included.
Background: Liver metastases are often the dominant site of metastatic disease in colorectal cancer. Selective internal radiation therapy (SIRT) involves embolising radiolabeled spheres (SIR-Spheres) into the arterial supply of the liver with the aim of improving the control of liver metastases.
Objectives: To assess the effectiveness and toxicity of SIRT in the treatment of metastatic colorectal cancer liver metastasis when given alone or with systemic or regional hepatic artery chemotherapy.
Selection criteria: Randomised controlled trials comparing SIRT and chemotherapy (systemic and/or regional) with chemotherapy alone, or comparing SIRT alone with best supportive care in patients with metastatic colorectal cancer.
Background: An up-to-date overview of the effectiveness and safety of dynamic exercise therapy (exercise therapy with a sufficient intensity, duration, and frequency to establish improvement in aerobic capacity and/or muscle strength) is lacking.
Objectives: To assess the effectiveness and safety of short-term (< three months) and long-term (> three months) dynamic exercise therapy programs (aerobic capacity and/or muscle strength training), either land or water-based, for people with RA. To do this we updated a previous Cochrane review (van den Ende 1998) and made categories for the different forms of dynamic exercise programs.
Selection criteria: RCTs that included an exercise program fulfilling the following criteria were selected: a) frequency at least twice weekly for > 20 minutes; b) duration > 6 weeks; c) aerobic exercise intensity > 55% of the maximum heart rate and/or muscle strengthening exercises starting at 30% to 50% of one repetition maximum; and d) performed under supervision. Moreover, the RCT included one or more of the following outcome measures: functional ability, aerobic capacity, muscle strength, pain, disease activity or radiological damage.
Background: Provision of assistive technology is a widely used intervention for people with rheumatoid arthritis. Assistive technology is any item used to increase or maintain functional ability in individuals with disabilities. It includes a wide range of products, from low-technology devices to technologically complex equipment. Yet, there are few systematic reviews on the effectiveness of assistive technology in this population.
Objectives: To assess the benefits of assistive technology for adults with rheumatoid arthritis in terms of improving functional ability and reducing pain, and to assess potential adverse effects in terms of psychological discomfort, personal injury or material damage related to device use.
Selection criteria: Included study designs were randomised controlled trials, clinical controlled trials, controlled before and after studies, and interrupted time series where the effectiveness of assistive technology was evaluated. In addition, comparative observational studies were included if addressing adverse effects.
Background: In many countries of the industrialised world second generation ('atypical') antipsychotics have become the first line drug treatment for people with schizophrenia. The question as to whether, and if so how much, the effects of the various new generation antipsychotics differ is a matter of debate. In this review we examined how the efficacy and tolerability of ziprasidone differs from that of other second generation antipsychotics.
Objectives: To evaluate the effects of ziprasidone compared with other atypical antipsychotics for people with schizophrenia and schizophrenia-like psychoses.
Selection criteria: We included all randomised, at least single-blind, controlled trials comparing oral ziprasidone with oral forms of amisulpride, aripiprazole, clozapine, olanzapine, quetiapine, risperidone or zotepine in people with schizophrenia or schizophrenia-like psychoses.
Background: Cardiovascular disease such as coronary artery disease, stroke and congestive heart failure, is a leading cause of death worldwide. A postulated risk factor is elevated circulating total homocysteine (tHcy) levels which is influenced mainly by blood levels of cyanocobalamin (vitamin B12), folic acid (vitamin B9) and pyridoxine (vitamin B6). There is uncertainty regarding the strength of association between tHcy and the risk of cardiovascular disease.
Objectives: To assess the clinical effectiveness of homocysteine-lowering interventions (HLI) in people with or without pre-existing cardiovascular disease.
Selection criteria: We included randomised clinical trials (RCTs) assessing the effects of HLI for preventing cardiovascular events with a follow-up period of 1 year or longer. We considered myocardial infarction and stroke as the primary outcomes. We excluded studies in patients with end-stage renal disease.
Background: In many countries of the industrialised world second generation (atypical) antipsychotics have become first line drug treatments for people with schizophrenia. The question as to whether, and if so how much, the effects of the various second generation antipsychotics differ is a matter of debate. In this review we examine how the efficacy and tolerability of aripiprazole differs from that of other second generation antipsychotics.
Objectives: To evaluate the effects of aripiprazole compared with other atypical antipsychotics for people with schizophrenia and schizophrenia-like psychoses.
Selection criteria: We included all randomised trials comparing oral aripiprazole with oral forms of amisulpride, clozapine, olanzapine, quetiapine, risperidone, sertindole, ziprasidone or zotepine in people with schizophrenia or schizophrenia-like psychoses.
Background: Gilles de la Tourette Syndrome (GTS) is a developmental neuropsychiatric disorder characterised by the presence of chronic motor and phonic tics. Drugs currently used in the treatment of GTS either lack efficacy or are associated with intolerable side effects. There is some anecdotal and experimental evidence that cannabinoids may be effective in treating tics and compulsive behaviour in patients with GTS. There are currently no systematic Cochrane reviews of treatments used in GTS. There is one other Cochrane review being undertaken at present, on the use of fluoxetine for tics in GTS.
Objectives: To evaluate the efficacy and safety of cannabinoids as compared to placebo or other drugs in treating tics, premonitory urges and obsessive compulsive symptoms (OCS), in patients with GTS.
Selection criteria: We included randomised controlled trials (RCTs) comparing any cannabinoid preparation with placebo or other drugs used in the treatment of tics and OCS in patients with GTS.
Background: Ocular injury is a preventable cause of blindness, yet it remains a significant disabling health problem that affects all age groups. Injuries may occur in the home, in the workplace, during recreational activities or as a result of road crashes. Types of injuries vary from closed globe (contusion or lamellar laceration) to an open globe injury, which includes penetration and even perforation of the globe. To date, the main strategy to prevent these injuries has been to educate people to identify high-risk situations and to take correct action to avoid danger.
Objectives: To assess the evidence for the effectiveness of educational interventions for the prevention of eye injuries.
Selection criteria: We included any randomised controlled trials (RCTs) and controlled before-and-after studies which evaluated any educational intervention aimed at preventing eye injuries.
Background: Traumatic physical injury can result in many disabling sequelae including physical and mental health problems and impaired social functioning.
Objectives: To assess the effectiveness of psychosocial interventions in the prevention of physical, mental and social disability following traumatic physical injury.
Selection criteria: Randomised controlled trials that consider one or more defined psychosocial interventions for the prevention of physical disability, mental health problems or reduced social functioning as a result of traumatic physical injury. We excluded studies that included patients with traumatic brain injury (TBI).
Background: Delirium occurs in 30% of hospitalised patients and is associated with prolonged hospital stay and increased morbidity and mortality. The results of uncontrolled studies have been unclear, with some suggesting that benzodiazepines may be useful in controlling non-alcohol related delirium.
Objectives: To determine the effectiveness and incidence of adverse effects of benzodiazapines in the treatment of non-alcohol withdrawal related delirium.
Selection criteria: Trials had to be unconfounded, randomized and with concealed allocation of subjects. Additionally, selected trials had to have assessed patients pre- and post-treatment. Where crossover design was present, only data from the first part of the trial were to be examined.
Background: Consensus statements recommend the addition of long-acting inhaled ss2-agonists (LABA) only in asthmatic patients who are inadequately controlled on inhaled corticosteroids (ICS). It is not uncommon for some patients to be commenced on ICS and LABA together as initial therapy.
Objectives: To compare the efficacy of combining inhaled corticosteroids with long-acting ss2-agonists (ICS+LABA) with inhaled corticosteroids alone (ICS alone) in steroid-naive children and adults with persistent asthma. We assessed two protocols: (1) LABA + ICS versus a similar dose of ICS (comparison 1) and (2) LABA + ICS versus a higher dose of ICS (comparison 2).
Selection criteria: Randomised trials comparing ICS + LABA with ICS alone in children and adults with asthma who had no inhaled corticosteroids in the preceding 28 days prior to enrolment.
Background: Pneumonia, caused by Streptococcus pneumoniae, is a major cause of morbidity and mortality among children in low-income countries. The effectiveness of pneumococcal conjugate vaccines (PCVs) against invasive pneumococcal disease (IPD), pneumonia, and mortality needs to be evaluated.
Objectives: To update the 2004 review on the efficacy of PCVs in preventing vaccine-serotypes IPD (VT-IPD) , X-ray defined pneumonia among HIV-1 negative children, and other new outcomes.
Selection criteria: Randomised controlled trials (RCTs) comparing PCV with placebo, or another vaccine, in children under two with IPD and clinical / radiographic pneumonia as outcomes.
Background: Editor's note: The anti-inflammatory drug rofecoxib (Vioxx) was withdrawn from the market at the end of September 2004 after it was shown that long-term use (greater than 18 months) could increase the risk of heart attack and stroke in a study of secondary prevention of adenoma recurrence. Further information is available at www.vioxx.com.Rofecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor previously licensed for treating acute and chronic pain; it was associated with fewer gastrointestinal adverse events than conventional NSAIDs. An earlier Cochrane review (Barden 2005) showed that rofecoxib is at least as effective as conventional non-steroidal anti-inflammatory drugs (NSAIDs) for postoperative pain.
Objectives: To assess the analgesic efficacy and adverse effects of rofecoxib in single oral doses for moderate and severe postoperative pain.
Selection criteria: Randomised, double blind, placebo-controlled trials of single dose orally administered rofecoxib in adults with moderate to severe acute postoperative pain.
Background: Approximately 60% of breast cancers amongst premenopausal women express the nuclear oestrogen receptor (ER+ breast cancer). Adjuvant endocrine therapy is an integral component of care for ER+ breast cancer, exerting its effect by reducing the availability of oestrogen to micrometastatic tumour cells. Endocrine strategies in premenopausal women include oestrogen receptor blockade with tamoxifen, temporary suppression of ovarian oestrogen synthesis by luteinising hormone releasing hormone (LHRH) agonists, or permanent interruption of ovarian oestrogen synthesis with oophorectomy or radiotherapy. Aromatase inhibitors are also available with concurrent suppression of ovarian oestrogen synthesis, either through LHRH agonists, surgery, or radiotherapy. Chemotherapy can also have an endocrine action in premenopausal women by interrupting ovarian oestrogen production, either temporarily or permanently. International consensus statements recommend single agent tamoxifen as the current standard adjuvant endocrine therapy for premenopausal women (often preceded by chemotherapy), and the role of LHRH agonists remains under active investigation.
Objectives: To assess LHRH agonists as adjuvant therapy for women with early breast cancer.
Selection criteria: All randomised trials assessing LHRH agonists as adjuvant treatment in premenopausal women with early stage breast cancer were included. Specifically, we included trials that compared:(A) LHRH agonists (experimental arm) versus another treatment;(B) LHRH agonists + anti-oestrogen (experimental arm) versus another treatment;(C) LHRH agonists + chemotherapy (experimental arm) versus another treatment;(D) LHRH agonists + anti-oestrogen + chemotherapy (experimental arm) versus another treatment.
Background: This is an update of a previous review (McGuinness 2006).Hypertension and cognitive impairment are prevalent in older people. Hypertension is a direct risk factor for vascular dementia (VaD) and recent studies have suggested hypertension impacts upon prevalence of Alzheimer's disease (AD). Therefore does treatment of hypertension prevent cognitive decline?
Objectives: To assess the effects of blood pressure lowering treatments for the prevention of dementia and cognitive decline in patients with hypertension but no history of cerebrovascular disease.
Selection criteria: Randomized, double-blind, placebo controlled trials in which pharmacological or non-pharmacological interventions to lower blood pressure were given for at least six months.
Background: Hypertension is associated with an increased risk of stroke, myocardial infarction and congestive heart failure. Methyldopa is a centrally acting antihypertensive agent, which was commonly used in the 1970's and 80's for blood pressure control. Its use at present has largely been replaced by antihypertensive drug classes with less side effects, but it is still used in developing countries due to its low cost. A review of its relative effectiveness compared to placebo on surrogate and clinical outcomes is justified.
Objectives: To quantify the effect of methyldopa compared to placebo in randomized controlled trials (RCTs) on all cause mortality, cardiovascular mortality, serious adverse events, myocardial infarctions, strokes, withdrawals due to adverse effects and blood pressure in patients with primary hypertension.
Selection criteria: We selected RCTs studying patients with primary hypertension. We excluded studies of patients with secondary hypertension or gestational hypertension.
Background: Periodontitis is a chronic infective disease of the gums caused by bacteria present in dental plaque. This condition induces the breakdown of the tooth supporting apparatus until teeth are lost. Surgery may be indicated to arrest disease progression and regenerate lost tissues. Several surgical techniques have been developed to regenerate periodontal tissues including guided tissue regeneration (GTR), bone grafting (BG) and the use of enamel matrix derivative (EMD). EMD is an extract of enamel matrix and contains amelogenins of various molecular weights. Amelogenins are involved in the formation of enamel and periodontal attachment formation during tooth development.
Objectives: To test whether EMD is effective, and to compare EMD versus GTR, and various BG procedures for the treatment of intrabony defects.
Selection criteria: RCTs on patients affected by periodontitis having intrabony defects of at least 3 mm treated with EMD compared with open flap debridement, GTR and various BG procedures with at least 1 year follow up. The outcome measures considered were: tooth loss, changes in probing attachment levels (PAL), pocket depths (PPD), gingival recessions (REC), bone levels from the bottom of the defects on intraoral radiographs, aesthetics and adverse events. The following time-points were to be evaluated: 1, 5 and 10 years.
Background: Dental implants require sufficient bone to be adequately stabilised. For some patients implant treatment would not be an option without horizontal or vertical bone augmentation. A variety of materials and surgical techniques are available for bone augmentation.
Objectives: To test whether and when augmentation procedures are necessary and which is the most effective technique for horizontal and vertical bone augmentation.
Selection criteria: Randomised controlled trials (RCTs) of different techniques and materials for augmenting bone horizontally or vertically or both for implant treatment reporting the outcome of implant therapy at least to abutment connection. Trials were divided into two broad categories: horizontal augmentation and vertical augmentation techniques.
Background: Idiopathic sudden sensorineural hearing loss (ISSHL) is sudden hearing loss where clinical assessment fails to reveal a cause. The most widely used therapeutic agents for ISSHL are antivirals, steroids, hyperbaric oxygen, vasodilators and rheological/vasoactive substances. There is currently conflicting evidence for vasodilator and vasoactive substances in the treatment of ISSHL.
Objectives: 1. To determine the effectiveness of vasodilators and other vasoactive substances in improving hearing in patients with ISSHL. 2. To determine the adverse effects of these medications.
Selection criteria: Randomised controlled trials (RCTs) of vasodilators/vasoactive substance versus placebo in the treatment of ISSHL. Trials were assessed for methodological quality.