TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Transcranial magnetic stimulation (TMS) was introduced as a neurophysiological technique in 1985 when Anthony Barker and his team developed a compact machine that permitted non-invasive stimulation of the cerebral cortex (Barker 1985). Since its introduction, TMS has been used to evaluate the motor system, to study the function of several cerebral regions, and for the pathophysiology of several neuropsychiatric illnesses. In addition, it has been suggested that TMS might have therapeutic potential. Some controlled studies have evaluated the effects of repetitive TMS (rTMS) in patients with obsessive-compulsive disorder (OCD). Greenberg (Greenberg 1997) observed that a single session of right prefrontal cortex stimulation produced a significant decrease in compulsive urges in OCD patients lasting over eight hours. Other studies have reported transitory improvements in mood but there are no observations for changes in anxiety or obsessions.
Objectives: To develop a systematic review on the clinical efficacy and safety of transcranial magnetic stimulation from randomised controlled trials in the treatment of obsessive-compulsive disorder.
Selection criteria: Randomised controlled trials assessing the therapeutic efficacy and safety of transcranial magnetic stimulation for obsessive-compulsive disorder.
Background: Considerable controversy exists as to whether any benefit of doxorubicin-based combination chemotherapy outweighs increased toxic effects, inconvenience, and additional costs, compared to single-agent doxorubicin. There is substantial variation in clinical practice in the treatment of patients with locally advanced and metastatic soft tissue sarcoma (STS).
Objectives: To determine:1) the effect, if any on response rate or survival, by using doxorubicin-based combination chemotherapy compared with single-agent doxorubicin for the treatment of patients with incurable locally advanced or metastatic STS2)if combination chemotherapy is associated with increased adverse effects compared with single-agent doxorubicin in this setting.
Selection criteria: Randomized controlled trials (RCTs) comparing single-agent doxorubicin with doxorubicin-based combination chemotherapy in adults with locally advanced or metastatic STS requiring palliative chemotherapy. Abstracts and full reports published in English were eligible.
Background: A major disadvantage of second trimester amniocentesis is that the result is usually available only after 18 weeks' gestation. Chorionic villus sampling (CVS) and early amniocentesis can be done between 9 and 14 weeks and offer an earlier alternative.
Objectives: The objective was to assess comparative safety and accuracy of second trimester amniocentesis, early amniocentesis, transcervical and transabdominal CVS.
Selection criteria: All randomised trials comparing amniocentesis and CVS.
Background: Tricyclic antidepressants are still extensively prescribed worldwide. Evidence for the recommended dosage of tricyclics, however, is poor.
Objectives: To compare the effects and side effects of low dosage tricyclic antidepressants with placebo and with standard dosage tricyclics in acute phase treatment of depression.
Selection criteria: All randomised controlled trials 1) comparing low dosage TCA (=< 100 mg/d on average at the end of trial) with placebo or 2) comparing low and standard dosages of the same TCA, in acute phase treatment of depressive disorder
Background: The prevention and early treatment of infections are the mainstay of the medical management of the majority of people with HIV infection, who live in low income countries without access to antiretroviral drugs. Cotrimoxazole is cheap and effective against a wide range of organisms. However, routine prophylactic treatment is difficult to deliver in low-resource settings, and could also lead to increased resistance to the drug.
Objectives: To assess the effects of routinely administered cotrimoxazole on death and illness episodes in HIV infected adults.
Selection criteria: Randomised or quasi randomised trials comparing routinely administered cotrimoxazole versus placebo or no treatment in adults (age greater than 13 years).
Background: Hip and knee replacement are common operative procedures to improve mobility and quality of life. Adequate pain relief is essential in the postoperative period to enable ambulation and initiation of physiotherapy. Lumbar epidural analgesia is a common modality for pain relief following these procedures. However, there is no systematic review of the evidence comparing the efficacy of epidural analgesia with other postoperative analgesic modalities. As the use of epidural analgesia may delay the initiation of anticoagulant thromboprophylaxis due to the potential risk of epidural hematoma, a synthesis of the evidence is necessary to determine whether or not alternative analgesic modalities are worse, equivalent, or better than epidural analgesia.
Objectives: Our objective is to answer the question: "Is lumbar epidural analgesia more efficacious than systemic analgesia or long-acting spinal analgesia for postoperative pain relief in patients after elective hip or knee replacement?"
Selection criteria: A study was included if it was a randomized or pseudo randomized controlled clinical trial of patients undergoing hip or knee replacement, in which postoperative lumbar epidural analgesia was compared to other methods for pain relief. Study selection was performed unblinded in duplicate.
Background: The colony stimulating factors (CSFs), granulocyte-macrophage colony stimulating factor (GM-CSF) and granulocyte colony stimulating factor (G-CSF), are naturally occurring cytokines that stimulate the production and antibacterial function of neutrophils and monocytes. Two strategies have been adopted for exploring whether CSFs can provide clinical benefit for preterm infants. The first has investigated their use as a treatment to improve outcome in established systemic infection, especially when complicated by a low neutrophil count. The alternative strategy has been to use CSFs prophylactically, to prevent sepsis prospectively through stimulation of neutrophil production and bactericidal function.
Objectives: To determine the efficacy and safety of the haemopoietic colony stimulating factors (G-CSF or GM-CSF) in newborn infants, when used for:a) treatment of suspected or proven systemic infection to reduce mortality, orb) prophylaxis, to prevent systemic infection in infants at high risk of nosocomial infection. To determine, in subgroup analysis, the influence of pre-existing or high risk of neutropenia on the outcome of therapy.
Selection criteria: The criteria used to select studies for inclusion were:
Background: Antiplatelet drugs are effective and safe in a wide variety of patients at high risk of vascular ischaemic events. Among patients undergoing vascular surgical procedures, these agents significantly reduce the risk of graft or native vessel occlusion. In this context we wished to examine their effects in patients after carotid endarterectomy (CEA).
Objectives: The objective of this review was to evaluate whether antiplatelet agents are safe and beneficial after endarterectomy of the internal carotid artery.
Selection criteria: We selected randomised, controlled, unconfounded trials comparing antiplatelet agents with control after carotid endarterectomy in symptomatic or asymptomatic carotid stenosis of different degrees. Treatment duration had to be at least 30 days after CEA. Follow-up should be at least three months.
Background: Focal cerebral ischaemia causes release of excitatory amino acid (EAA) neurotransmitters, principally glutamate, with resultant over-stimulation of EAA receptors and downstream pathways. Excess glutamate release is a pivotal event in the evolution of irreversible ischaemic damage in animal models of ischaemia, and drugs that modulate glutamate action either by inhibiting its release, or blocking post-synaptic receptors, are potent neuroprotective agents. Many clinical trials with EAA modulating drugs have been conducted, none individually demonstrating efficacy.
Objectives: To synthesise all the available data on all different classes of EAA modulators and to evaluate evidence of effects on outcome systematically.
Selection criteria: Trials were included if they were randomised, controlled studies giving agents with pharmacological properties that included modification of release of EAAs, or blockade of EAA receptors, in stroke within 24h of onset. Efficacy analysis was restricted to trials with a parallel group design: dose escalation studies were excluded. Intention-to-treat analyses were performed on all data. Outcome had to be reported in terms of death or dependence 1-12 months after the acute event.
Background: Health workers recommend bathing, sponging and other physical methods to treat fever in children and to avoid febrile convulsions. We know little about the most effective methods, or how these methods compare with commonly used drugs.
Objectives: To evaluate the benefits and harms of physical cooling methods used for managing fever in children.
Selection criteria: Randomized and quasi-randomized trials comparing physical methods with a drug placebo or no treatment in children with fever of presumed infectious origin. Studies where children in both groups were given an antipyretic drug were included.
Background: The prevalence of shoulder disorders has been reported to range from seven to 36% of the population (Lundberg 1969) accounting for 1.2% of all General Practitioner encounters in Australia (Bridges Webb 1992). Substantial disability and significant morbidity can result from shoulder disorders. While many treatments have been employed in the treatment of shoulder disorders, few have been proven in randomised controlled trials. Physiotherapy is often the first line of management for shoulder pain and to date its efficacy has not been established. This review is one in a series of reviews of varying interventions for shoulder disorders, updated from an earlier Cochrane review of all interventions for shoulder disorder.
Objectives: To determine the efficacy of physiotherapy interventions for disorders resulting in pain, stiffness and/or disability of the shoulder.
Selection criteria: Each identified study was assessed for possible inclusion by two independent reviewers. The determinants for inclusion were that the trial be of an intervention generally delivered by a physiotherapist, that treatment allocation was randomised; and that the study population be suffering from a shoulder disorder, excluding trauma and systemic inflammatory diseases such as rheumatoid arthritis.
Background: The use of muscle relaxants in the management of non-specific low back pain is controversial. It is not clear if they are effective, and concerns have been raised about the potential adverse effects involved.
Objectives: The aim of this review was to determine if muscle relaxants are effective in the treatment of non-specific low back pain.
Selection criteria: Randomised and/or double-blinded controlled trials, involving patients diagnosed with non-specific low back pain, treated with muscle relaxants as monotherapy or in combination with other therapeutic modalities, were included for review.
Background: Fibrin sealants have gained increasing popularity as interventions to improve peri-operative (intra/post-operative) haemostasis and diminish the need for allogeneic red cell transfusion (blood from an unrelated donor).
Objectives: To examine the efficacy of fibrin sealants in reducing peri-operative blood loss and allogeneic red blood cell (RBC) transfusion.
Selection criteria: Controlled trials in which adult patients, scheduled for elective surgery, were randomised to fibrin sealant treatment or to a control group who did not receive fibrin sealant treatment. Trials were eligible if they reported data on the number of patients exposed to allogeneic red cell transfusion, the volume of blood transfused, or blood loss (assessed objectively).
Background: Patent Ductus Arteriosus (PDA remains a significant cause of mortality and morbidity in premature infants. Indomethacin is an effective treatment to close a PDA, and has been used for many years with several treatment regimes, including prophylactic use in all at risk premature infants. There are however concerns regarding adverse side effects of indomethacin. By targeting a group of infants with an asymptomatic PDA, rather than treating all VLBW infants prophylactically, indomethacin use would be restricted, limiting the possibility of significant side effects to those with greater chance of benefit.
Objectives: To assess whether in premature neonates with asymptomatic PDA, treatment with indomethacin improves short and long term outcomes; in particular: incidence of symptomatic PDA, mortality, chronic neonatal lung disease (CLD), intraventricular haemorrhage (IVH), retinopathy of prematurity (ROP), neurodevelopmental outcome, length of ventilation.
Selection criteria: All randomised controlled trials of indomethacin compared with placebo or no intervention for the treatment of asymptomatic PDA in premature infants were eligible.
Background: Anticholinergics were the first drugs available for the symptomatic treatment of Parkinson's disease and they are still widely used today, both as monotherapy and as part of combination regimes. They are commonly believed to be associated with a less favourable side effect profile than other antiparkinsonian drugs, in particular with respect to neuropsychiatric and cognitive adverse events. They have been claimed to exert a better effect on tremor than on other parkinsonian features.
Objectives: To determine the efficacy and tolerability of anticholinergics in the symptomatic treatment of Parkinson's disease compared to placebo or no treatment.
Selection criteria: Randomised controlled trials of anticholinergic drugs versus placebo or no treatment in de-novo or advanced Parkinson's disease, either as monotherapy or as an add-on to other antiparkinsonian drugs were included. Trials of anticholinergic drugs that were never in general clinical use were excluded.
Background: Depressive disorder is a common mental disorder in old age, with serious health consequences such as increased morbidity, disability, and mortality. The frailty of elderly may seriously hamper the efficacy and safety of pharmacotherapy in depressed elderly. Electroconvulsive therapy (ECT) in depressed elderly therefore may be an alternative to treatment with antidepressants.
Objectives: To assess the efficacy and safety of ECT (compared to simulated ECT or antidepressants) in depressed elderly.
Selection criteria: Data were independently extracted by at least two reviewers. Randomised, controlled trials on depressed elderly (> 60 years) with or without concomitant with conditions like cerebrovascular disease, dementia of the Alzheimer's type, vascular dementia or Parkinson's disease were included.
Background: Oxygen has long been implicated in the pathogenesis of retinopathy of prematurity (ROP) and is rigorously monitored in today's neonatal intensive care units. Recent research using a feline model has shown an improvement in ROP outcome of kittens treated with supplemental oxygen. Current treatment for ROP by retinal ablation is not without complications so a non-invasive method of treatment is preferred. The possible effects of long term oxygen supplementation on chronic lung disease, length of hospital stay and growth and development are, however, unknown.
Objectives: To determine whether, in preterm or low birth weight infants with prethreshold ROP, targeting higher as compared to normal transcutaneous oxygen levels or pulse oximetry levels when using supplemental oxygen reduces the progression of ROP to threshold disease and improves visual outcome without any adverse effects.
Selection criteria: All randomised or quasi randomised studies comparing higher versus normal target oxygen levels in preterm or low birthweight infants with prethreshold ROP were eligible for inclusion.
Background: Abnormal involuntary movements known as dyskinesias are amongst the most disabling side-effects of levodopa therapy. It is thought that amantadine, an NMDA-receptor antagonist, may reduce dyskinesias in patients with Parkinson's disease without worsening Parkinsonian symptoms.
Objectives: To compare the efficacy and safety of adjuvant amantadine therapy versus placebo in treating dyskinesia in patients with Parkinson's disease, already established on levodopa, and suffering from motor complications.
Selection criteria: Randomised controlled trials comparing amantadine with placebo in the treatment of dyskinesia in patients with a clinical diagnosis of idiopathic Parkinson's disease.
Background: There are a number of effective interventions for the treatment of depression. It is possible that the efficacy of these treatments will be improved further by the use of adjunctive therapies such as folate.
Objectives: 1. To determine the effectiveness of folate in the treatment of depression 2. To determine the adverse effects and acceptability of treatment with folate.
Selection criteria: All randomised controlled trials that compared treatment with folic acid or 5'-methyltetrahydrofolic acid to an alternative treatment, whether another antidepressant medication or placebo, for patients with a diagnosis of depressive disorder (diagnosed according to explicit criteria).
Background: Breast self-examination and clinical breast examination have been promoted for many years as general screening methods to diagnose breast cancer at an earlier stage in order to decrease morbidity and or mortality. The possible benefits and harms remain unclear.
Objectives: To determine whether screening for breast cancer by regular self-examination or clinical breast examination reduces breast cancer mortality and morbidity.
Selection criteria: Randomised clinical trials, including cluster randomised trials.
Background: The patient with diabetes has many different learning needs relating to diet, monitoring, and treatments. In many health care systems specialist nurses provide much of these needs, usually aiming to empower patients to self-manage their diabetes. The present review aims to assess the effects of the involvement of specialist nurse care on outcomes for people with diabetes, compared to usual care in hospital clinics or primary care with no input from specialist nurses.
Objectives: To assess the effects of diabetes specialist nurses / nurse case manager in diabetes on the metabolic control of patients with type 1 and type 2 diabetes mellitus.
Selection criteria: Randomised controlled trials and controlled clinical trials of the effects of a specialist nurse practitioner on short and long term diabetic outcomes were included in the review.
Background: Dementia is a common mental health problem affecting 5% of those over 65. Various pathological processes are linked to memory impairment in dementia, particularly those affecting the cholinergic neurotransmitter system. Acetyl-l-carnitine (ALC) is derived from carnitine and is described as having several properties which may be beneficial in dementia. This includes activity at cholinergic neurons, membrane stabilization and enhancing mitochondrial function. Work on the effects of ALC has been ongoing since the 1980s yet the efficacy of ALC in cognitive decline remains unclear. Early studies suggested a beneficial effect of ALC on cognition and behaviour in aging subjects. However, later, larger studies have not supported these findings. Some of the difficulties lie in the early and later studies differing widely in methodology and assessment tools used, and are therefore difficult to compare. ALC is not currently in routine clinical use.
Objectives: The objective of this review is to establish whether Acetyl-l-carnitine is clinically effective in the treatment of people with dementia.
Selection criteria: All double-blind, randomized, trials involving people with dementia in which treatment with ALC was compared with a placebo group
Background: Smoking cessation is the most important treatment for smokers with chronic obstructive pulmonary disease (COPD), but little is known about the effectiveness of different smoking cessation interventions for this particular group of patients.
Objectives: To determine the effectiveness of smoking cessation interventions in people with COPD.
Selection criteria: Randomised controlled trials in which smoking cessation was assessed in participants with confirmed COPD.
Background: Systemic corticosteroids are used routinely in the management of children with severe acute asthma. There is a lack of consensus regarding the agent, dose and route of corticosteroid administration.
Objectives: To determine the benefit of systemic corticosteroids (oral, intravenous, or intramuscular) compared to placebo and inhaled steroids in acute paediatric asthma.
Selection criteria: Studies were included if they described a randomised controlled trial (RCT) involving children aged 1-18 years with severe acute asthma who received oral, inhaled, intravenous or intramuscular corticosteroids. Only studies in which patients required hospital admission were included.
Background: Both chemotherapy and endocrine therapy can be used as treatments for metastatic breast cancer.
Objectives: To review the evidence and determine whether chemotherapy or endocrine therapy has the most beneficial effect on treatment outcomes (survival, response rate, toxicity and quality of life).
Selection criteria: Randomised trials comparing the effects of chemotherapy alone with endocrine therapy alone on pre-specified endpoints in metastatic breast cancer.
Background: Oxatomide is a histamine H1-receptor antagonist. As an oral agent, oxatomide may be useful in managing asthma. Some guidelines recommend oxatomide for long-term prophylaxis of asthma in children. There is no clear evidence whether children or adults with asthma benefit from oxatomide.
Objectives: To determine whether oxatomide alone, or in combination with other interventions, results in better disease control in people with asthma.
Selection criteria: Studies were randomised, placebo-controlled trials and the interventions were oxatomide or matched placebo given alone or in combination with other asthma-medication for at least 4 weeks.
Background: Asthma education and self-management are key recommendations of asthma management guidelines because they improve health outcomes. There are several different modalities for the delivery of asthma self-management education.
Objectives: We evaluated programmes that: 1) Optimised asthma control through inhaled corticosteroid use by regular medical review or optimised asthma control by individualised written action plans 2) Used written self-management plans based on peak expiratory flow self-monitoring compared with symptom self-monitoring 3) Compared different options for the delivery of optimal self-management programmes.
Selection criteria: Randomised trials of asthma self-management education interventions in adults over 16 years of age with asthma.
Background: Mucous membrane pemphigoid and epidermolysis bullosa acquisita are acquired autoimmune blistering diseases of the skin. Although they are rare, both can result in scarring of mucous membranes, which may lead to blindness and life threatening respiratory complications.
Objectives: To assess the effects of treatments for mucous membrane pemphigoid and epidermolysis bullosa acquisita.
Selection criteria: RCTs involving participants of any ages, and with a diagnosis confirmed by immunofluorescence. Where no RCTs were located, studies with other designs were considered.