TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Diabetic renal disease (diabetic nephropathy) is a leading cause of end-stage renal failure. Once the process has started, it cannot be reversed by glycaemic control, but progression might be slowed by control of blood pressure and protein restriction.
Objectives: To assess the effects of dietary protein restriction on the progression of diabetic nephropathy in patients with diabetes.
Selection criteria: Randomised controlled trials (RCTs) and before and after studies of the effects of a modified or restricted protein diet on diabetic renal function in people with type 1 or type 2 diabetes following diet for at least four months were considered.
Background: Some authors have suggested that loxapine is more effective than typical antipsychotics in reducing the negative symptoms of schizophrenia, that extrapyramidal adverse effects are not usually seen at clinically effective antipsychotic doses and that it should therefore be classed as atypical.
Objectives: To determine the effects of loxapine compared with placebo, typical and other atypical antipsychotic drugs for schizophrenia and related psychoses.
Selection criteria: We included all randomised controlled clinical trials relevant to the care of schizophrenia that compared loxapine to other treatments.
Background: Antibiotic therapy for suspected acute bacterial meningitis (ABM) needs to be started immediately, even before the results of cerebrospinal fluid (CSF) culture and antibiotic sensitivity are available. Immediate commencement of effective treatment using the intravenous route may reduce death and disability. Although bacterial meningitis guidelines advise the use of third generation cephalosporins, these drugs are often not available in hospitals in low income countries.
Objectives: The objective of this review was to compare the effectiveness and safety of third generation cephalosporins and conventional treatment with penicillin or ampicillin-chloramphenicol in patients with community-acquired ABM.
Selection criteria: Randomised controlled trials (RCTs) comparing ceftriaxone or cefotaxime with conventional antibiotics as empirical therapy for acute bacterial meningitis.
Background: Lateral and posterior position of the baby's head (the back of the baby's head facing to the mother's side or back) may be associated with more painful, prolonged or obstructed labour and difficult delivery. It is possible that certain positions adopted by the mother may influence the baby's position.
Objectives: To assess the effects of adopting a hands and knees maternal posture in late pregnancy or during labour when the presenting part of the fetus is in a lateral or posterior position compared with no intervention.
Selection criteria: Randomised trials of hands and knees maternal posture compared to other postures or controls.
Background: Hydrocephalus following intraventricular hemorrhage (IVH) is still one of the most serious complications of premature birth. Ventriculoperitoneal shunt surgery cannot be carried out early and permanent dependence on a shunt is associated with several serious complications. Streptokinase could be useful in the treatment of post-hemorrhagic hydrocephalus. This form of therapy is based on the hypothesis that multiple blood clots in the cerebrospinal fluid (CSF) are the initial cause of post-hemorrhagic ventricular dilatation and lysis of clots could reopen the pathways of circulation and re-absorption of CSF.
Objectives: To determine the effect of intraventricular streptokinase after intraventricular hemorrhage on the risk of permanent shunt dependence, neurodevelopmental disability or death in neonates at risk for, or actually developing post-hemorrhagic hydrocephalus (PHH).
Selection criteria: Randomized controlled trials and quasi-randomized controlled trials evaluating the use of injection of streptokinase into the CSF in infants having or at risk for post-hemorrhagic hydrocephalus.
Background: Educational outreach visits (EOVs) have been identified as an intervention that may improve the practice of healthcare professionals. This type of face-to-face visit has been referred to as university-based educational detailing, academic detailing, and educational visiting.
Objectives: To assess the effects of EOVs on health professional practice or patient outcomes.
Selection criteria: Randomised trials of EOVs that reported an objective measure of professional performance or healthcare outcomes. An EOV was defined as a personal visit by a trained person to healthcare professionals in their own settings.
Background: Lipid-lowering therapy is recommended for secondary prevention in people with coronary artery disease. It may also reduce cardiovascular events and/or local disease progression in people with lower limb peripheral arterial disease (PAD).
Objectives: To assess the effects of lipid-lowering therapy on all-cause mortality, cardiovascular events and local disease progression in patients with PAD of the lower limb.
Selection criteria: Randomised controlled trials of lipid-lowering therapy in patients with PAD of the lower limb.
Background: People with depression often experience interpersonal problems. Family therapy for depression is a widely used intervention, but it is unclear whether this is an effective therapy for the treatment of depression.
Objectives: To assess the efficacy of family therapy for depression.
Selection criteria: Included studies were randomised controlled and controlled clinical trials comparing family therapy with no intervention or an alternative intervention in which depression symptomatology was a main outcome measure.
Background: Diabetes has long been recognised as a strong, independent risk factor for cardiovascular disease, a problem which accounts for approximately 70% of all mortality in people with diabetes. Prospective studies show that compared to their non-diabetic counterparts, the relative risk of cardiovascular mortality for men with diabetes is two to three and for women with diabetes is three to four. The two biggest trials in type 2 diabetes, the United Kingdom Prospective Diabetes Study (UKPDS) and the University Group Diabetes Program (UGDP) study did not reveal a reduction of cardiovascular endpoints through improved metabolic control. Theoretical benefits of the peroxisome proliferator activated receptor gamma (PPAR-gamma) activator rosiglitazone on endothelial function and cardiovascular risk factors might result in fewer macrovascular disease events in people with type 2 diabetes mellitus.
Objectives: To assess the effects of rosiglitazone in the treatment of type 2 diabetes.
Selection criteria: Studies were included if they were randomised controlled trials in adult people with type 2 diabetes mellitus and had a trial duration of at least 24 weeks.
Background: Postoperative morbidity and mortality are high in patients undergoing pancreatico-duodenectomy for malignant pancreatico-biliary stricture. Different approaches have been tried to improve the outcomes, including pre-surgical biliary stenting with endoscopic retrograde cholangiopancreaticography (ERCP).
Objectives: To assess the beneficial and harmful effects of biliary stenting via ERCP for pancreatico-biliary stricture confirmed or suspected to be malignant, prior to surgery.
Selection criteria: Randomised trials comparing ERCP with biliary stenting versus ERCP without biliary stenting for pancreatico-biliary malignancy prior to surgery.
Background: Azathioprine is used for patients with primary biliary cirrhosis, but the therapeutic responses in randomised clinical trials have been conflicting.
Objectives: To assess the benefits and harms of azathioprine for patients with primary biliary cirrhosis.
Selection criteria: Randomised clinical trials comparing azathioprine versus placebo, no intervention, or another drug were included irrespective of blinding, language, year of publication, and publication status.
Background: Cyclosporin A has been used for patients with primary biliary cirrhosis, but the therapeutic responses in randomised clinical trials have been heterogeneous.
Objectives: To assess the beneficial and harmful effects of cyclosporin A for patients with primary biliary cirrhosis.
Selection criteria: Randomised clinical trials comparing cyclosporin A with placebo, no intervention, or another drug were included irrespective of blinding, language, year of publication, and publication status.
Background: Obesity is increasingly prevalent, yet the nutritional management remains contentious. It has been suggested that low glycaemic index or load diets may stimulate greater weight loss than higher glycaemic index or load diets or other weight reduction diets.
Objectives: To assess the effects of low glycaemic index or load diets for weight loss in overweight or obese people.
Selection criteria: Randomised controlled trials comparing a low glycaemic index or load diet (LGI) with a higher glycaemic index or load diet or other diet (Cdiet) in overweight or obese people.
Background: Routine use of nasogastric tubes after abdominal operations is intended to hasten the return of bowel function, prevent pulmonary complications, diminish the risk of anastomotic leakage, increase patient comfort and shorten hospital stay.
Objectives: To investigate the efficacy of routine nasogastric decompression after abdominal surgery in achieving each of the above goals.
Selection criteria: Patients having abdominal operations of any type, emergency or elective, who were randomised prior tot he completion of the operation to receive a nasogastric tube and keep it in place until intestinal function had returned, versus those receiving either no tube or early tube removal, in surgery, in recovery or within 24 hours of surgery. Excluded will be randomised studies involving laparoscopic abdominal surgery and patient groups having gastric decompression through gastrostomy.
Background: Smallpox was eradicated by 1980, but its possible use as a bioweapon has rekindled interest in the development of protective vaccines. Therefore, stockpiled calf lymph-derived vaccines and recently developed cell-cultured vaccines have been investigated to contribute information to smallpox emergency response plans, while newer (non-replication competent) vaccines are developed.
Objectives: To assess the effects of smallpox vaccines in preventing the disease, in inducing immunity, and in regard to adverse events.
Selection criteria: Randomized controlled trials of smallpox vaccines versus placebo, other smallpox or non-smallpox vaccine, no intervention, or different dose of the same vaccine in people receiving smallpox vaccination irrespective of age.
Background: Normal sexual function is a biopsychosocial process and relies on the coordination of psychological, endocrine, vascular, and neurological factors. Recent data show that psychological factors are involved in a substantial number of cases of erectile dysfunction (ED) alone or in combination with organic causes. However, in contrast to the advances in somatic research of erectile dysfunction, scientific literature shows contradictory reports on the results of psychotherapy for the treatment of ED.
Objectives: To evaluate the effectiveness of psychosocial interventions for the treatment of ED compared to oral drugs, local injection, vacuum devices and other psychosocial interventions, that may include any psycho-educative methods and psychotherapy, or both, of any kind.
Selection criteria: All relevant randomised and quasi-randomised controlled trials evaluating psychosocial interventions for ED.
Background: Adhesions are the leading cause of small bowel obstruction. Gastrografin transit time may allow for the selection of appropriate patients for non-operative management. Some studies have shown when the contrast does not reach the colon after a designated time it indicates complete intestinal obstruction that is unlikely to resolve with conservative treatment. When the contrast does reach the large bowel, it indicates partial obstruction and patients are likely to respond to conservative treatment. Other studies have suggested that the administration of water-soluble contrast is therapeutic in resolving the obstruction.
Objectives: To determine the reliability of water-soluble contrast media and serial abdominal radiographs in predicting the success of conservative treatment in patients admitted with adhesive small bowel obstruction.Furthermore, to determine the efficacy and safety of water-soluble contrast media in reducing the need for surgical intervention and reducing hospital stay in adhesive small bowel obstruction.
Selection criteria: 1. Prospective studies were included to evaluate the diagnostic potential of water-soluble contrast in adhesive small bowel obstruction.2. Randomised clinical trials were selected to evaluate the therapeutic role.
Background: Patients often do not get the information they require from doctors and nurses. To address this problem, interventions directed at patients to help them gather information in their healthcare consultations have been proposed and tested.
Objectives: To assess the effects on patients, clinicians and the healthcare system of interventions which are delivered before consultations, and which have been designed to help patients (and/or their representatives) address their information needs within consultations.
Selection criteria: Randomised controlled trials of interventions before consultations designed to encourage question asking and information gathering by the patient.
Background: Paracetamol has been commonly used for the relief of postoperative pain following oral surgery. In this review we investigated the optimal dose of paracetamol and the optimal time for drug administration to provide pain relief, taking into account the side effects of different doses of the drug. This will inform dentists and their patients of the best strategy for pain relief after the surgical removal of wisdom teeth.
Objectives: To assess the beneficial and harmful effects of paracetamol for pain relief after surgical removal of lower wisdom teeth, compared to placebo, at different doses and administered postoperatively.
Selection criteria: Randomised, parallel group, placebo controlled, double blind clinical trials of paracetamol for acute pain, following third molar surgery.
Background: Whooping cough is a highly contagious disease. Infants are at highest risk of severe disease and death. Erythromycin for 14 days is currently recommended for treatment and contact prophylaxis, but is of uncertain benefit.
Objectives: To study the benefits and risks of antibiotic treatment of and contact prophylaxis against whooping cough.
Selection criteria: All randomised and quasi-randomised controlled trials of antibiotics for treatment of, and contact prophylaxis against, whooping cough.
Background: Intubation is associated with bacterial colonisation of the respiratory tract and, therefore, may increase the risk of acquiring an infection. The infection may prolong the need for mechanical ventilation and increase the risk of chronic lung disease. The use of prophylactic antibiotics has been advocated for all mechanically ventilated newborns in order to reduce the risk of colonisation and the acquisition of infection. However, there is the possibility that the harm this may cause might outweigh the benefit.
Objectives: To assess the effects of prophylactic antibiotics on mortality and morbidity in intubated, ventilated newborn infants who are not known to have infection. In separate comparisons, two different policies regarding the prophylactic use of antibiotics in intubated, ventilated infants were reviewed: 1) among infants who have been intubated for mechanical ventilation, a policy of prophylactic antibiotics for the duration of intubation versus placebo or no treatment 2) among intubated, ventilated infants who have been started on antibiotics at the time of intubation but whose initial cultures to rule out sepsis were negative, a policy of continuing versus discontinuing prophylactic antibiotics.
Selection criteria: Randomised controlled trials of sufficient quality in which mechanically ventilated newborn infants are randomised to receive prophylactic antibiotics versus placebo or no treatment.
Background: Vaccination is recognized as the only practical measure for preventing Japanese encephalitis. Production shortage, costs, and issues of licensure impair vaccination programmes in many affected countries. Concerns over vaccine effectiveness and safety also have a negative impact on acceptance and uptake.
Objectives: To evaluate vaccines for preventing Japanese encephalitis in terms of effectiveness, adverse events, and immunogenicity.
Selection criteria: Randomized controlled trials (RCTs), including cluster-RCTs, comparing Japanese encephalitis vaccines with placebo (inert agent or unrelated vaccine), no intervention, or alternative Japanese encephalitis vaccine.
Background: While initial dietary management immediately after formal diagnosis is an 'accepted' cornerstone of treatment of type 2 diabetes mellitus, a formal and systematic overview of its efficacy and method of delivery is not currently available.
Objectives: To assess the effects of type and frequency of different types of dietary advice for adults with type 2 diabetes.
Selection criteria: All randomised controlled trials, of six months or longer, in which dietary advice was the main intervention.
Background: Childhood-onset schizophrenia is schizophrenia with onset prior to the age of 13 years. Although it is rare, people who suffer from schizophrenia at an early age appear to have a clinically severe form of the illness with poor long-term prognosis. Antipsychotic medication is one way of managing this rare but serious mental illness.
Objectives: To examine the effects of antipsychotic medication for childhood-onset schizophrenia.
Selection criteria: We included all randomised clinical trials involving children and young people with a diagnosis of childhood onset schizophrenia (i.e. with a diagnosis of schizophrenia before the age of 13) comparing any antipsychotic drug with another antipsychotic or placebo.
Background: Many patients visit their general practitioner (GP) because of problems that are psychosocial in origin. However, for many of these problems there is no evidence-based treatment available in primary care, and these patients place time-consuming demands on their GP. Therefore, GPs could benefit from tools to help these patients more effectively and efficiently. In this light, it is important to assess whether structured psychosocial interventions might be an appropriate tool for GPs. Previous reviews have shown that psychosocial interventions in primary care seem more effective than usual care. However, these interventions were mostly performed by health professionals other than the GP.
Objectives: To examine the effectiveness of psychosocial interventions by general practitioners by assessing the clinical outcomes and the methodological quality of selected studies.
Selection criteria: Randomised controlled trials, controlled clinical trials and controlled patient preference trials addressing the effectiveness of psychosocial interventions by GPs for any problem or disorder. Studies published before November 2005 were eligible for entry.
Background: Subclinical hypothyroidism is defined as an elevated serum thyroid-stimulating hormone (TSH) level with normal free thyroid hormones values. The prevalence of subclinical hypothyroidism is 4% to 8% in the general population, and up to 15% to 18% in women who are over 60 years of age. There is considerable controversy regarding the morbidity, the clinical significance of subclinical hypothyroidism and if these patients should be treated.
Objectives: To assess the effects of thyroid hormone replacement for subclinical hypothyroidism.
Selection criteria: All studies had to be randomised controlled trials comparing thyroid hormone replacement with placebo or no treatment in adults with subclinical hypothyroidism. Minimum duration of follow-up was one month.
Background: The use of educational and behavioural interventions in the management of chronic asthma have a strong evidence base. There may be a role for educative interventions following presentation in an emergency setting in adults.
Objectives: To assess the effectiveness of educational interventions administered following an acute exacerbation of asthma leading to presentation in the emergency department.
Selection criteria: Randomised, parallel group trials were eligible if they recruited adults (> 17 years) who had presented at an emergency department with an acute asthma exacerbation. The intervention of interest was any educational intervention (for example, written asthma management plan).
Background: Structured antenatal education programs for childbirth or parenthood, or both, are commonly recommended for pregnant women and their partners by healthcare professionals in many parts of the world. Such programs are usually offered to groups but may be offered to individuals.
Objectives: To assess the effects of this education on knowledge acquisition, anxiety, sense of control, pain, labour and birth support, breastfeeding, infant-care abilities, and psychological and social adjustment.
Selection criteria: Randomized controlled trials of any structured educational program provided during pregnancy by an educator to either parent that included information related to pregnancy, birth or parenthood. The educational interventions could have been provided on an individual or group basis. Educational interventions directed exclusively to either increasing breastfeeding success, knowledge of and coping skills concerning postpartum depression, improving maternal psycho-social health including anxiety, depression and self-esteem or reducing smoking were excluded.
Background: Despite drug and surgical therapies for Parkinson's disease, patients develop progressive disability. It has both motor and non-motor symptomatology, and their interaction with their environment can be very complex. The role of the occupational therapist is to support the patient and help them maintain their usual level of self-care, work and leisure activities for as long as possible. When it is no longer possible to maintain their usual activities, occupational therapists support individuals in changing and adapting their relationship with their physical and social environment to develop new valued activities and roles.
Objectives: To compare the efficacy and effectiveness of occupational therapy with placebo or no interventions (control group) in patients with Parkinson's disease.
Selection criteria: Only randomised controlled trials (RCT) were included, however those trials that allowed quasi-random methods of allocation were allowed.
Background: Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic potentially life threatening condition resulting from an excessive ovarian stimulation. Its reported incidence varies from one percent to ten percent of in vitro fertilization (IVF) cycles. The factors leading to this syndrome have not been completely explained. It seems likely that the release of vasoactive substances, secreted by the ovaries under human chorionic gonadotropin (hCG) stimulation plays a key role in triggering this syndrome. The hallmark of this condition, is a massive shift of fluid from the intra-vascular compartment to the third space resulting in profound intra-vascular depletion and haemoconcentration.
Objectives: To evaluate (i) the effectiveness of cryopreservation (embryo freezing) for the prevention of OHSS when compared with human intra-venous albumin infusion (ii) the effectiveness of the elective cryopreservation (embryo freezing ) of all embryos for the prevention of OHSS when compared with fresh embryo transfer.
Selection criteria: Randomised controlled trials (RCTs) in which either human intra-venous albumin or cryopreservation of all embryos were used as a therapeutic approach to OHSS were included. The women were women of reproductive age who were down regulated by gonadotrophin-releasing hormone-analogue (GnRH-a), undergoing superovulation in in vitro fertilization and or intra-cytoplasmic sperm injection (IVF and or ICSI) cycles.