TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Occupational therapy aims to help people reach their maximum level of function and independence in all aspects of daily life.
Objectives: To determine whether occupational therapy focused specifically on personal activities of daily living improves recovery for patients following stroke.
Selection criteria: We identified randomised controlled trials of an occupational therapy intervention (compared to usual care or no care) where stroke patients practiced personal activities of daily living, or performance in activities of daily living was the focus of the occupational therapy intervention.
Background: Polydipsia is the intake of more than three litres of fluids per day. Primary polydipsia occurs when excessive drinking cannot be explained by an identified medical condition, and is not secondary to polyuria. The prevalence of this problem in psychiatric inpatients has been estimated at between 6 and 17%. It can hinder standard care and be a highly disabling, even life-threatening condition.
Objectives: To review the effect of pharmacological interventions for the treatment of psychosis-related polydipsia.
Selection criteria: We included all randomised controlled trials involving people with a psychotic illness and secondary polydipsia, which evaluated drug treatments, and measured clinically meaningful outcomes.
Background: Many women would like to avoid pharmacological or invasive methods of pain management in labour and this may contribute towards the popularity of complementary methods of pain management. This review examined currently available evidence supporting the use of alternative and complementary therapies for pain management in labour.
Objectives: To examine the effects of complementary and alternative therapies for pain management in labour on maternal and perinatal morbidity.
Selection criteria: The inclusion criteria included published and unpublished randomised controlled trials comparing complementary and alternative therapies (but not biofeedback) with placebo, no treatment or pharmacological forms of pain management in labour. All women whether primiparous or multiparous, and in spontaneous or induced labour, in the first and second stage of labour were included.
Background: The main rationale for the use of lithium in the long-term treatment of unipolar affective disorder is its efficacy in treating bipolar affective disorder and resistant depression. However, there is considerable uncertainty about which pharmacological intervention is most effective in the long-term treatment of recurrent unipolar affective disorder.
Objectives: To assess the effects of lithium versus antidepressants for the long-term treatment of recurrent affective disorder.
Selection criteria: Randomised controlled trials comparing lithium against antidepressant medication for the long-term treatment of patients with a diagnosis of affective disorder.
Background: Malaria is the most common precipitating cause of crises in sickle cell disease in malaria-endemic countries. Health professionals often recommend life-long malaria chemoprophylaxis for people with sickle cell disease living in these areas. It is therefore important we have good evidence of benefit.
Objectives: To assess the effects of routine malaria chemoprophylaxis in people with sickle cell disease.
Selection criteria: Randomized and quasi-randomized controlled trials comparing chemoprophylaxis with any antimalarial drug given for a minimum of three months compared with a placebo or no intervention.
Background: Pedestrians and cyclists account for nearly one in three of all road users killed and seriously injured in road traffic crashes. Late detection of other road users is one of the basic driver failures responsible for collisions. Aids to improve pedestrians and cyclist visibility have been used to avert potential collisions. However, the impact of these strategies on drivers' responses, and on pedestrian and cyclist safety is not known.
Objectives: 1. To quantify the effect of visibility aids versus no visibility aids, and of different visibility aids on the occurrence of pedestrian and cyclist-motor vehicle collisions and injuries. 2. To quantify the effect of visibility aids versus no visibility aids, and of different visibility aids on drivers' detection and recognition responses.
Selection criteria: 1. Randomised controlled trials and controlled before-and-after studies of the effect of visibility aids on the occurrence of pedestrian and cyclist-motor collisions and injuries. 2. Randomised controlled trials of the effect of visibility aids on drivers' detection and recognition responses. This included trials where the order of presentation of visibility aids was randomised or balanced using a Latin square design.
Background: Alcohol is one of the most common causes of liver disease in the Western World. Randomised clinical trials have examined the effects of anabolic-androgenic steroids for alcoholic liver disease.
Objectives: To assess the beneficial and harmful effects of anabolic-androgenic steroids for patients with alcoholic liver disease based on the results of randomised clinical trials.
Selection criteria: Randomised clinical trials studying patients with alcoholic steatosis, alcoholic fibrosis, alcoholic hepatitis, and/or alcoholic cirrhosis were included. Interventions encompassed anabolic-androgenic steroids at any dose or duration versus placebo or no intervention. The trials could be double blind, single blind, or unblinded. The trials could be unpublished or published, and no language limitations were applied.
Background: Helium and oxygen mixtures (heliox), have been used sporadically in respiratory medicine for decades. Their use in acute respiratory emergencies such as asthma has been the subject of considerable debate. Despite the lapse of more than 60 years since it was first proposed, the role of heliox in treating patients with severe acute asthma remains unclear.
Objectives: To determine the effect of the addition of heliox to standard medical care on the course of acute asthma, as measured by pulmonary function testing and clinical endpoints.
Selection criteria: 1) randomised, single or double blind, controlled trials; 2) children or adults with a clinical diagnosis of acute asthma seen in emergency departments or equivalent acute care settings; and 3) compared treatment with inhaled heliox to placebo (oxygen or air).
Background: Zotepine is a relatively new antipsychotic often used for the treatment of people with schizophrenia. It is claimed to be particularly effective for negative symptoms.
Objectives: To determine the effects of zotepine compared with placebo, typical and other atypical antipsychotic drugs for schizophrenia and related psychoses.
Selection criteria: We included all randomised clinical trials comparing zotepine with other treatments for people with schizophrenia or other psychoses.
Background: Displaced intracapsular fractures may be treated by either reduction and internal fixation, which preserves the femoral head, or by replacement of the femoral head with an arthroplasty.
Objectives: To review all randomised controlled trials that have compared internal fixation with arthroplasty for intracapsular femoral fractures in adults.
Selection criteria: All randomised and quasi-randomised controlled trials comparing internal fixation with arthroplasty for intracapsular hip fractures in adults.
Background: Primary prevention programmes in many countries attempt to reduce mortality and morbidity due to coronary heart disease (CHD) through risk factor modification. It is widely believed that multiple risk factor intervention using counselling and educational methods is efficacious and cost-effective and should be expanded. Recent trials examining risk factor changes have cast considerable doubt on the effectiveness of these multiple risk factor interventions.
Objectives: To assess the effects of multiple risk factor intervention for reducing cardiovascular risk factors, total mortality, and mortality from CHD among adults without clinical evidence of established cardiovascular disease.
Selection criteria: Intervention studies using counselling or education to modify more than one cardiovascular risk factor in adults from general populations, occupational groups, or high risk groups. Trials of less than 6 months duration were excluded.
Background: Head injury increases the body's metabolic responses, and therefore nutritional demands. Provision of an adequate supply of nutrients is associated with improved outcome. The best route for administering nutrition (parenterally (TPN) or enterally (EN)), and the best timing of administration (for example, early versus late) of nutrients needs to be established.
Objectives: To quantify the effect on mortality and morbidity of alternative strategies of providing nutritional support following head injury.
Selection criteria: Randomised controlled trials of timing or route of nutritional support following acute traumatic brain injury.
Background: Cataract accounts for 50% of blindness globally and remains the leading cause of visual impairment in all regions of the world, despite improvements in surgical outcomes (WHO 2005). This number is expected to rise due to an aging population and increase in life expectancy. Although cataracts are not preventable, their surgical treatment is one of the most cost-effective interventions in healthcare.
Objectives: To compare the effects of different surgical interventions for age-related cataract.
Selection criteria: We included randomised controlled trials (RCTS).
Background: Randomised clinical trials have compared portosystemic shunting procedures with endoscopic therapy for variceal haemorrhage, but there is no consensus as to which approach is preferable.
Objectives: To compare the effects of shunts (total surgical shunt (TS); distal spleno-renal shunts (DSRS) or transjugular intrahepatic porto-systemic shunts (TIPS) with endoscopic therapy (ET, sclerotherapy and/or banding) for prevention of variceal rebleeding in patients with cirrhosis.
Selection criteria: Randomised clinical trials comparing TS, DSRS or TIPS with ET in patients who had recovered from a variceal haemorrhage and were known to be cirrhotic.
Background: Structured treatment interruptions (STI) of antiretroviral therapy (ART) have been investigated as part of novel treatment strategies, with different aims and objectives depending on the populations involved. These populations include: 1) patients who initiate ART during acute HIV infection; 2) patients with chronic HIV infection, on ART, with successfully suppressed viremia; and 3) patients with chronic HIV infection and treatment failure, with persistent viremia due to multi-drug resistant HIV (Hirschel 2001; Deeks 2002; Miller 2003). In an earlier Cochrane review (Pai 2005), we had summarized the evidence about the effects of STI in chronic suppressed HIV infection. In this review, we summarize the evidence on STI in patients with chronic unsuppressed HIV infection due to drug-resistant HIV. Unsuppressed HIV infection describes those patients who cannot suppress viremia, due to the presence of multi-drug-resistant virus. It is also referred to as treatment failure. Drug resistance is identified by the presence of resistant mutations at baseline.STI as a treatment strategy in HIV-infected patients with chronic unsuppressed viremia involves interrupting ART in controlled clinical settings, for a pre-specified duration of time. These interruptions have various aims, including the following: 1) to allow wild virus to re-emerge and replace the resistant mutant virus, with the hope of improving the efficacy of a subsequent ART regimen; 2) to halt development of drug resistance and to preserve subsequent treatment options; 3) to alleviate treatment fatigue and reduce drug-related adverse effects; and 4) to improve quality of life (Miller 2003; Montaner 2001; Vella 2000;).
Objectives: The objective of our systematic review was to synthesize the evidence on the effect of structured treatment interruptions in adult patients with chronic unsuppressed HIV infection.
Selection criteria: Inclusion criteriaAll available randomized or non-randomized controlled trials investigating planned treatment interruptions among patients with chronic unsuppressed HIV infection. Early pilot non-randomized prospective studies on treatment interruptions of fixed and variable durations were also included. Relevant abstracts on randomized controlled trials were also included if they contained sufficient information. Exclusion criteriaEditorials, reviews, modeling studies, and basic science studies were excluded. Studies on STI among patients with chronic suppressed HIV infection were summarized in a separate review. Studies on STI in primary HIV infection were beyond the scope of this review.
Background: Azapirones are a group of drugs that work at the 5-HT1A receptor and are used to treat patients suffering from generalized anxiety disorder (GAD). However, several studies have shown conflicting results. Whether azapirones are useful as first line treatment in general anxiety disorders still needs to be answered.
Objectives: To assess the efficacy and the acceptability of azapirones for the treatment of GAD.
Selection criteria: Randomized controlled trials of azapirones, including buspirone versus placebo and/or other medication and/or psychological treatment, were included. Participants were males and females of all ages with a diagnosis of generalized anxiety disorder.
Background: Chronic obstructive pulmonary disease (COPD) is a condition associated with high morbidity, mortality and cost to the community. Patients often report symptomatic improvement with long acting beta-2 agonists (LABAs) and anticholinergic bronchodilator medications, both of which are recommended in COPD guidelines. These medications have different mechanisms of action and therefore theoretically could have an additive effect when combined. As these medications are prescribed in COPD as long term therapy, it is important to assemble reliable evidence on their relative and additive effects.
Objectives: To compare the relative efficacy and safety of regular long term use (at least four weeks) of ipratropium bromide and LABA in patients with stable COPD. Comparisons were made between single agents and in combination versus LABAs alone.
Selection criteria: All randomised controlled trials comparing treatment for at least four weeks with an anticholinergic agent (ipratropium bromide) alone or in combination with LABA versus LABA alone, delivered via metered dose inhaler or nebuliser, in non-asthmatic adult subjects with stable COPD.
Background: The suggestion that garlic may lower blood pressure, inhibit platelet aggregation, and reduce oxidative stress has led to the hypothesis that it may have a role in preventing pre-eclampsia and its complications.
Objectives: To assess the effects of garlic on prevention of pre-eclampsia and its complications.
Selection criteria: Studies were included if they were randomised trials evaluating the effects of garlic on prevention of pre-eclampsia and its complications.
Background: Acute otitis media (AOM) is a spontaneously remitting disease for which pain is the most distressing symptom. Antibiotics are now known to have less benefit than previously assumed.
Objectives: To assess the effectiveness of topical analgesia for AOM.
Selection criteria: Double-blind randomised or quasi-randomised controlled trials comparing an otic preparation with an analgesic effect (excluding antibiotics) versus placebo or an otic preparation with an analgesic effect (excluding antibiotics) versus any other otic preparation with an analgesic effect, in adults or children presenting at primary care settings with AOM without perforation.
Background: Negative symptoms are common in people with schizophrenia and are often difficult to treat with antipsychotic drugs. Treatment often involves the use of various add-on medications such as antidepressants.
Objectives: To review the effects of the combination of antipsychotic and antidepressant drug treatment for management of negative symptoms in schizophrenia and schizophrenia-like psychoses.
Selection criteria: We included all randomised controlled trials comparing antipsychotic and antidepressant combinations with antipsychotics alone for the treatment of prominent negative symptoms in schizophrenia and/or schizophrenia-like psychoses.
Background: Systemic antibiotics and antibiotic-impregnated shunt systems are often used to prevent shunt infection.
Objectives: To evaluate the effectiveness of either prophylactic systemic antibiotics or antibiotic-impregnated shunt systems for preventing infection in patients who underwent surgical introduction of intracranial ventricular shunts.
Selection criteria: We included randomized or quasi-randomized controlled trials comparing the use of prophylactic antibiotics (either systemic or antibiotic-impregnated shunt systems) in intracranial ventricular shunt procedures with placebo or no antibiotics.
Background: Intermittent wheezing illnesses, which include viral associated wheeze and asthma, are amongst the most common reasons for children to present urgently to a doctor. Whether parents should commence oral corticosteroids (OCS) for an episode of acute wheeze in their child without waiting for a medical review is an important question, as the potential benefits of early oral corticosteroid intervention have to be weighed against the potential adverse effects of treatment.
Objectives: The objectives were to assess the benefits and harmful effects of parent-initiated OCS, in the management of intermittent wheezing illnesses in children, based on the results of randomised clinical trials.
Selection criteria: Only randomised clinical trials studying patients aged between one and eighteen years old, with an intermittent wheezing illness (asthma, viral wheeze, preschool viral wheeze) were included. Interventions encompassed OCS at any dose or duration versus placebo or other drug combination. The trials could be unpublished or published and no language limitations were applied.
Background: Women in normal labour may sometimes go on to have general anaesthesia if labour becomes abnormal, for example if a caesarean section is required. General anaesthesia carries a very small risk of regurgitation and inhalation of stomach contents into the lungs. This can cause inflammation, particularly if the fluid is acidic, and can lead to severe morbidity and very occasionally mortality. Labour hormones increase the risk of gastric aspiration or Mendelsohn's syndrome, though the exact incidence is unknown. The routine administration of acid prophylaxis drugs to all women in normal labour is commonly practiced worldwide, to reduce gastric aspiration by reducing the volume and acidity of stomach contents.
Objectives: To assess the effectiveness of routine prophylaxis drugs for women in normal labour to reduce gastric aspiration and its effects.
Selection criteria: Randomised and quasi-randomised controlled trials of women in normal labour assessing the routine administration of drugs (antacids, H(2) receptor antagonists, dopamine antagonists and proton-pump inhibitors) compared with placebo/no treatment, and compared with other drugs for reducing gastric aspiration.
Background: There are two injectable progestogen-only contraceptives (IPCs) that have been available in many countries in the world since 1983. They are both still extensively used in many developing countries, forming a large proportion of the health system's expenditure on contraception. These are depot medroxyprogesterone acetate (DMPA) and norethisterone oenanthate (NET-EN). These are both highly effective contraceptives that receive wide acceptance amongst women in their fertile years. They differ in frequency of administration that has implications on patient uptake. They also differ in cost that may significantly affect budgeting in the health system. A systematic comparison will aid to ensure their rational use.
Objectives: To determine if there are differences between depot medroxyprogesterone acetate given at a dose of 150 mg IM every 3 months and norethisterone oenanthate given at a dose of 200mg IM every 2 months, in terms of contraceptive effectiveness, reversibility and discontinuation patterns, minor effects and major effects.
Selection criteria: All randomised controlled comparisons of DMPA acetate given at a dose of 150 mg IM every 3 months versus NET-EN given at a dose of 200mg IM every 2 months, used for contraception, were included. Trials had to report on contraceptive efficiency and return to fertility, discontinuation risks and reasons for discontinuation, and clinical effects, both menstrual and non-menstrual.
Background: Selenium supplements are frequently used by cancer patients. Selenium is an essential trace element and is involved in antioxidant protection and redox-regulation in humans. Several adverse effects of radiotherapy and chemotherapy in cancer patients as well as cellular processes that maintain chronic lymphoedema have been linked to oxidative cell damage in the human body. Selenium has recently been investigated as a remedy against chemotherapy and radiotherapy-associated side effects as well as its effects on lymphoedema.
Objectives: This review assessed the effects of supplementary selenium on adverse effects of conventional radiotherapy, chemotherapy, or surgery, in oncologic patients and on quality of life or performance status during and after oncologic treatment.
Selection criteria: Randomised-controlled trials of selenium mono-supplements in cancer patients undergoing tumour specific therapy such as chemotherapy, radiotherapy or surgery.
Background: Early aggressive behaviour is a risk factor for later violence and criminal behaviour. Despite over 20 years of violence prevention interventions being delivered in the school setting, questions remain regarding the effectiveness of different interventions for children exhibiting aggressive behaviour.
Objectives: To examine the effect of school based violence prevention programmes for children identified as aggressive or at risk of being aggressive.
Selection criteria: We included trials meeting the following criteria; 1) participants were randomly assigned to intervention and control groups; 2) outcome data were collected concurrently; 3) participants comprised children in mandatory education identified as exhibiting, or at risk of, aggressive behaviour; 4) interventions designed to reduce aggression, violence, bullying, conflict or anger; 5) school based interventions; 6) outcomes included aggressive behaviour, school and agency responses to acts of aggression, or violent injuries.
Background: The importance of consumer involvement in health care is widely recognised. Consumers can be involved in developing healthcare policy and research, clinical practice guidelines and patient information material, through consultations to elicit their views or through collaborative processes. Consultations can be single events, or repeated events, large or small scale. They can involve individuals or groups of consumers to allow debate; the groups may be convened especially for the consultation or be established consumer organisations. They can be organised in different forums and through different media. We anticipated finding few comparative evaluations that reliably evaluated the effects of consumer involvement.
Objectives: To assess the effects of consumer involvement and compare different methods of involvement in developing healthcare policy and research, clinical practice guidelines, and patient information material.
Selection criteria: Randomised and quasi-randomised trials, interrupted time series analyses, and controlled before-after studies assessing methods for involving consumers in developing healthcare policy and research, clinical practice guidelines or patient information material. The outcome measures were: participation or response rates of consumers; consumer views elicited; consumer influence on decisions, healthcare outcomes or resource utilisation; consumers' or professionals' satisfaction with the involvement process or resulting products; impact on the participating consumers; costs.