TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Contracts are a verbal or written agreement that a patient makes with themselves, with healthcare practitioners, or with carers, where participants commit to a set of behaviours related to the care of a patient. Contracts aim to improve the patients' adherence to treatment or health promotion programmes.
Objectives: To assess the effects of contracts between patients and healthcare practitioners on patients' adherence to treatment, prevention and health promotion activities, the stated health or behaviour aims in the contract, patient satisfaction or other relevant outcomes, including health practitioner behaviour and views, health status, reported harms, costs, or denial of treatment as a result of the contract.
Selection criteria: We included randomised controlled trials comparing the effects of contracts between healthcare practitioners and patients or their carers on patient adherence, applied to diagnostic procedures, therapeutic regimens or any health promotion or illness prevention initiative for patients. Contracts had to specify at least one activity to be observed and a commitment of adherence to it. We included trials comparing contracts with routine care or any other intervention.
Background: In type 2 diabetes mellitus, impairment of insulin secretion is an important component of the disease. Meglitinide analogues are a class of oral hypoglycaemic agents that increase insulin secretion, in particular, during the early phase of insulin release.
Objectives: The aim of this review was to assess the effects of meglitinide analogues in patients with type 2 diabetes mellitus.
Selection criteria: We included randomised controlled, parallel or cross-over trials comparing at least 10 weeks of treatment with meglitinide analogues to placebo, head-to-head, metformin or in combination with insulin.
Background: Electromyographic biofeedback (EMG-BFB) is a technique that is believed to have additional benefit when used with standard physiotherapy for the recovery of motor function in stroke patients. However, evidence from individual trials and previous systematic reviews has been inconclusive.
Objectives: To assess the effects of EMG-BFB for motor function recovery following stroke.
Selection criteria: Randomised and quasi-randomised studies comparing EMG-BFB with control for motor function recovery in stroke patients.
Background: Studies have shown improved survival of newborn infants maintained in the thermoneutral range. The concept of an incubator with additional insulation, a double plexiglass wall, is appealing for very low birth weight infants as it may help to provide a thermoneutral environment.
Objectives: To assess the effects of double walled incubator versus a single wall incubator on insensible water loss, rate of oxygen consumption, episodes of hypothermia, time to regain birth weight, duration of hospitalization and infant mortality in premature infants.
Selection criteria: Only studies using random or quasi-random methods of allocation were considered for this review. Eligible studies assessed at least one of the outcome variables identified as important to this topic.
Background: In many places, children newly diagnosed with type 1 diabetes mellitus are admitted to hospital for metabolic stabilisation and training, even if they are not acutely ill. Out-patient or home based management of these children could avoid the stress associated with a hospital stay, could provide a more natural learning environment for the child and its family, and might reduce costs for both the health care system and the families.
Objectives: To assess the effects of routine hospital admission compared to out-patient or home-based management in children newly diagnosed with type 1 diabetes mellitus.
Selection criteria: Comparative studies of initial hospitalisation compared to home-based and/or out-patient management in children with newly diagnosed type 1 diabetes.
Background: Prolotherapy involves repeated injections of irritant solutions to strengthen lumbosacral ligaments and reduce some types of chronic low-back pain; spinal manipulation and exercises are often used to enhance its effectiveness.
Objectives: To determine the efficacy of prolotherapy in adults with chronic low-back pain.
Selection criteria: We included randomised (RCT) and quasi-randomised controlled trials (QRCT) that compared prolotherapy injections to control injections, alone or in combination with other treatments, which measured pain or disability before and after the intervention.
Background: Approximately 15% to 25% of all hospitalised patients have indwelling urethral catheters, mainly to assist clinicians to accurately monitor urine output during acute illness or following surgery, to treat urinary retention, and for investigative purposes.
Objectives: The objective of this review was to determine the best strategies for the removal of catheters from patients with a short-term indwelling urethral catheter. The main outcome of interest was the number of patients who required recatheterisation following removal of indwelling urethral catheter.
Selection criteria: All randomised and quasi-randomised controlled trials (RCTs) that compared the effects of alternative strategies for removal of short-term indwelling urethral catheters on patient outcomes were considered for inclusion in the review.
Background: Bed rest is prescribed to all patients with acute myocardial infarction (AMI), but to a variable extent. Current guidelines (American College of Cardiology/ American Heart Association) recommend at least 12 hours bed rest in patients with uncomplicated ST-elevation myocardial infarction, however the basis for this recommendation is unclear.
Objectives: To compare the effects of short versus longer bed rest in patients with uncomplicated AMI.
Selection criteria: Randomised and quasi-randomised controlled trials of short versus longer bed rest in patients with uncomplicated AMI were sought.
Background: Indomethacin is a prostaglandin inhibitor used to treat patent ductus arteriosus (PDA) in preterm infants. Although indomethacin produces ductal closure in the majority of cases, it is ineffective in up to 40% of patients. Furthermore, the ductus will re-open in up to 35% of infants who initially respond to the drug. Prolonging the course of indomethacin has the potential to achieve higher rates of ductal closure.
Objectives: To determine the effect of a prolonged course of indomethacin (compared to a short course) on the rate of treatment failure without unwanted side-effects in preterm infants with PDA.
Selection criteria: Randomized or quasi-randomized controlled trials including preterm infants with PDA, diagnosed on clinical and/or echocardiographic examination that evaluated indomethacin treatment by any route given as a long course (four or more doses) vs. a short course (three or fewer doses) were included in the review. Trials needed to report on at least one of the following outcomes: failure of PDA to close, need for re-treatment, PDA re-opening, PDA ligation, mortality, duration of assisted ventilation, chronic lung disease (CLD), duration of supplemental oxygen dependence, intraventricular hemorrhage (IVH) (all and severe), diminished urine output, increased serum creatinine, necrotizing enterocolitis (NEC), bleeding diathesis, retinopathy of prematurity (ROP), and duration of hospital stay.
Background: Many treatments are available for whiplash patients but there is little scientific evidence for their accepted use. Patients with whiplash-associated disorders (WAD) can be classified by the severity of signs and symptoms from Grade 0 (no complaints or physical signs) to Grade 4 (fracture or dislocation).
Objectives: To assess the effectiveness of conservative treatment for patients with whiplash injuries rated as Grades 1 or 2 (neck and musculoskeletal complaints).
Selection criteria: We selected randomised controlled trials published in English, French, German or Dutch, that included patients with a whiplash-injury, conservative interventions, outcomes of pain, global perceived effect or participation in daily activities.
Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) can play a major role in the management of acute pain in the peri-operative period. However, there are conflicting views on whether NSAIDs are associated with adverse renal effects.
Objectives: The primary objective of this review was to determine the effects of NSAIDs on postoperative renal function in adults with normal preoperative renal function.
Selection criteria: The inclusion criteria were randomised or quasi-randomised comparisons of individual NSAIDs with either each other or placebo for treatment of postoperative pain, with relevant postoperative renal outcome measures, in adult surgical patients with normal renal function.
Background: Mortality and morbidity from acute myocardial infarction (AMI) remain high. Intravenous magnesium started early after the onset of AMI is thought to be a promising adjuvant treatment. Conflicting results from earlier trials and meta-analyses warrant a systematic review of available evidence.
Objectives: To examine the effect of intravenous magnesium versus placebo on early mortality and morbidity.
Selection criteria: All randomized controlled trials that compared intravenous magnesium with placebo in the presence or absence of fibrinolytic therapy in addition to routine treatment were eligible if they reported mortality and morbidity within 35 days of AMI onset.
Background: The Nursing led inpatient Unit (NLU) is one of a range of services that have been considered in order to manage more successfully the transition between hospital and home for patients with extended recovery times. This is an update of an earlier review published in The Cochrane Library in Issue 3, 2004.
Objectives: To determine whether nursing-led inpatient units are effective in preparing patients for discharge from hospital compared to usual inpatient care.
Selection criteria: Controlled trials and interrupted time series designs that compared the NLU to usual inpatient care managed by doctors. Patients over 18 years of age following an acute hospital admission for a physical health condition.
Background: Incontinence is a common and embarrassing problem which has a profound effect on social and psychological well-being. Many people wear absorbent products to contain urine leakage and protect their clothes. It can be difficult to define light urinary incontinence because urine volumes, flow and frequency rates may vary substantially whilst still being considered 'light'. Light incontinence may encompass occasional (monthly) leaks of very small amounts (e.g. 1 g to 2 g) up to frequent leaks (several times per day) of larger amounts (e.g. 20 g to 50 g). A practical definition is urine loss that can be contained within a small absorbent pad (typically 50 g to 500 g; ISO 1996).
Objectives: To assess the effectiveness of different types of absorbent product designs for women with light urinary incontinence.
Selection criteria: TYPES OF STUDIES: All randomised or quasi-randomised trials of absorbent products for women with light urinary incontinence.
Background: Disc prolapse accounts for five percent of low-back disorders but is one of the most common reasons for surgery.
Objectives: The objective of this review was to assess the effects of surgical interventions for the treatment of lumbar disc prolapse.
Selection criteria: Randomized trials (RCT) and quasi-randomized trials (QRCT) of the surgical management of lumbar disc prolapse.
Background: Glucocorticoid use in rheumatoid arthritis (RA) is widespread. Two Cochrane Reviews have been published examining the short term clinical benefit of low dose glucocorticoids compared to non-steroidal anti-inflammatory drugs and demonstrate good short term and medium term clinical benefits. The possibility that glucocorticoids may have a fundamental 'disease modifying' effect in RA, which would be seen by a reduction in the rate of radiological progression, has been raised by several authors.
Objectives: To perform a systematic review of studies evaluating glucocorticoid efficacy in inhibiting the progression of radiological damage in rheumatoid arthritis.
Selection criteria: Randomized controlled or cross-over trials in adults with a diagnosis of rheumatoid arthritis in which prednisone or a similar glucocorticoid preparation was compared to either placebo controls or active controls (i.e. comparative studies) and where there was evaluation of radiographs of hands, or hands and feet, or feet by any standardised technique. Eligible studies had at least one treatment arm with glucocorticoids and one without glucocorticoids.
Background: Chlorpromazine, one of the first generation of antipsychotic drugs, is effective in the treatment of schizophrenia. For most people schizophrenia is a life-long disorder but about a quarter of those who have a first psychotic breakdown do not go on to experience further breakdowns. Most people with schizophrenia are prescribed antipsychotic drugs, although use is often intermittent. The effects of stopping medication are not well researched in the context of systematic reviews.
Objectives: To quantify the effects of stopping chlorpromazine for people with schizophrenia stable on this drug.
Selection criteria: We included all relevant randomised clinical trials.
Background: A high incidence of functional decline (deterioration in physical or cognitive function) during hospitalisation of older adults is reported. The role of exercise in preventing these deconditioning effects is unclear.
Objectives: To determine the effect of exercise interventions for acutely hospitalised older medical patients on functional status, adverse events and hospital outcomes.
Selection criteria: Eligible studies were prospective randomised controlled trials (RCT) or prospective controlled clinical trials (CCT) comparing exercise for acutely hospitalised older medical patients to usual care or no treatment controls.
Background: Observational studies have shown an association between transiently low thyroid hormone levels in preterm infants in the first weeks of life (transient hypothyroxinaemia) and abnormal neurodevelopmental outcome. Thyroid hormone replacement might prevent this.
Objectives: To determine whether prophylactic thyroid hormones given to preterm infants without congenital hypothyroidism result in clinically important changes in neonatal and long term outcomes.
Selection criteria: All trials using random or quasi-random patient allocation in which prophylactic thyroid hormone treatment was compared to control in premature infants.
Background: Extremely premature infants are at risk of transient hypothyroxinaemia in the first weeks after birth. These low thyroid hormone levels are associated with an increased incidence of neonatal morbidity, mortality and longer term developmental impairments. Thyroid hormone therapy might prevent these problems.
Objectives: To determine the evidence for thyroid hormone therapy in preterm infants with transient hypothyroxinaemia (low thyroid hormone level, normal TSH) for improvement of neonatal outcomes and neurodevelopment.
Selection criteria: Trials enrolling preterm infants with transient hypothyroxinaemia (low thyroid hormone level, normal TSH level) in the neonatal period, using random or quasi-random patient allocation to thyroid hormone therapy compared to control (placebo or no treatment).
Background: Preterm birth causes 60% to 80% of neonatal deaths. Survivors can experience life-long complications. The risk of preterm labour in the presence of maternal infection is thought to be 30% to 50%. Probiotics are defined as live micro-organisms which, when administered in an adequate amount, confer a health benefit on the host. They have been shown to displace and kill pathogens and modulate the immune response by interfering with the inflammatory cascade that leads to preterm labour and delivery. During pregnancy, local treatment restoring normal vaginal flora and acidity without systemic effects could be preferable to other treatment in preventing preterm labour.
Objectives: To evaluate the effectiveness and the safety of probiotics for preventing preterm labour and birth.
Selection criteria: All randomised controlled trials assessing the prevention of preterm birth in pregnant women and women planning pregnancy through the use of probiotics to treat or prevent urogenital infections.
Background: Malignant pleural mesothelioma (MPM) is a highly aggressive malignancy whose incidence is expected to increase in the United Kingdom, Western Europe, and Australia over the next 20 years as a result of occupational exposure to asbestos fibres. Surgery is feasible in only a small proportion of cases, and radiotherapy and cytotoxic chemotherapy are used in palliation. Pemetrexed is the first and only chemotherapy agent that has been granted a marketing approval for use in combination with cisplatin for the treatment of chemo-naïve patients with unresectable MPM.
Objectives: To examine evidence on the clinical effectiveness of pemetrexed disodium used in combination with cisplatin for the treatment of unresectable malignant pleural mesothelioma in chemotherapy naïve patients compared with other cytotoxic agents used alone or in combination, or supportive care.
Selection criteria: Randomised Controlled Trials (RCTs) where the use of pemetrexed disodium in combination with cisplatin is compared with other cytotoxic agents, or supportive care for the treatment of malignant pleural mesothelioma (or non-RCTs, in the absence of RCT data ).
Background: Weight gain is common for people with schizophrenia and this has serious implications for health and well being.
Objectives: To determine the effects of both pharmacological (excluding medication switching) and non pharmacological strategies for reducing or preventing weight gain in people with schizophrenia.
Selection criteria: We included all clinical randomised controlled trials comparing any pharmacological or non pharmacological intervention for weight gain (diet and exercise counselling) with standard care or other treatments for people with schizophrenia or schizophrenia-like illnesses.
Background: Low systemic blood flow (SBF) is common in extremely premature infants in the first day after birth and has been associated with peri / intraventricular haemorrhage (PIVH), necrotising enterocolitis (NEC), mortality and developmental impairment.
Objectives: To determine the effect of specific inotropes on morbidity and mortality in preterm infants with low systemic blood flow
Selection criteria: Random and quasi-random controlled trials of inotropes enrolling preterm infants with low systemic or organ blood flow in the neonatal period.
Background: Autistic spectrum disorder encompasses a wide variety of behavioural and communicative problems. Both the core features and non-core features of autism have been targeted in a variety of therapies. Atypical antipsychotic medications, including risperidone, have been used for symptom and behaviour improvement and have shown beneficial outcomes, particularly in certain aspects of the disorder. However, given the nature of the condition presenting in young patients, the risks of these potentially long term therapies must be weighed against the benefits.
Objectives: To determine the efficacy and safety of risperidone for people with autism spectrum disorder.
Selection criteria: All randomised controlled trials of risperidone versus placebo for patients with a diagnosis of autism spectrum disorder. All trials had to have at least one standardised outcome measure used for both intervention and control group.
Background: Non-alcoholic fatty liver disease (NAFLD) is characterised by fatty deposition in the hepatocytes of patients with minimal or no alcohol intake and without other known cause. NAFLD includes a wide spectrum of histologic abnormalities ranging from hepatic steatosis to non-alcoholic steatohepatitis (NASH), or even cirrhosis. Antioxidant supplements, therefore, could potentially protect cellular structures against oxidative stress and the resulting lipid peroxidation.
Objectives: To systematically evaluate the beneficial and harmful effects of antioxidant supplements versus no intervention, placebo, or other interventions for patients with NAFLD or NASH.
Selection criteria: Randomised clinical trials evaluating any antioxidant supplements versus no intervention, placebo, or other interventions in patients with NAFLD or NASH. Our inclusion criteria for NAFLD or NASH were based on history of minimal or no alcohol intake, imaging techniques showing hepatic steatosis, and/or histological evidence of hepatic damage (including simple steatosis, fatty infiltration plus nonspecific inflammation, steatohepatitis, fibrosis, and cirrhosis), and by exclusion of other causes of hepatic steatosis.
Background: Obesity is one of the major public health problems of modern society. Intragastric balloon (IGB) treatment for obesity has been developed as a temporary aid. Its primary objective is the treatment of obese people, who have had unsatisfactory results in their clinical treatment for obesity, despite of being cared for by a multidisciplinary team, and super obese patients with a higher surgical risk. However, the effects of different IGB procedures compared with conventional treatments and with each other are uncertain.
Objectives: To assess the effects of intragastric balloon in people with obesity.
Selection criteria: Randomised and quasi-randomised controlled trials fulfilling the inclusion criteria were used. Short term weight loss is common, so studies were included if they reported measurements after a minimum of four weeks follow-up.
Background: Recurrence rates for bipolar disorder are high despite effective treatments with mood stabiliser drugs. Self-help treatments and psychological treatments that teach patients to recognise and manage early warning symptoms and signs (EWS) of impending manic or depressive episodes are popular with patients. The main aim of such interventions is to intervene early and prevent bipolar episodes, thereby increasing the time to the next recurrence and preventing hospitalisation.
Objectives: To compare the effectiveness of an EWS intervention plus treatment as usual (TAU ) versus TAU (involving and not involving a psychological therapy) on time to manic, depressive and all bipolar episodes (the primary outcome), hospitalisation, functioning, depressive and manic symptoms.
Selection criteria: Only randomised controlled trials (RCTs) were included. Participants were adults with a diagnosis of bipolar disorder based on standardised psychiatric criteria.
Background: The use of loop ileostomy or loop transverse colostomy represents an important issue in colorectal surgery. Despite a slight preference for a loop ileostomy as a temporary stoma, the best form for temporary decompression of colorectal anastomosis still remains controversial.
Objectives: To assess the evidence in the use of loop ileostomy compared with loop transverse colostomy for temporary decompression of colorectal anastomosis, comparing the safety and effectiveness.
Selection criteria: We assessed all randomised clinical trials, that met the objectives and reported major outcomes: 1. Mortality; 2. Wound infection; 3. Time of formation of stoma; 4. Time of closure of stoma; 5. Time interval between formation and closure of stoma; 6. Stoma prolapse; 7. Stoma retraction; 8. Parastomal hernia; 9. Parastomal fistula; 10. Stenosis; 11. Necrosis; 12. Skin irritation; 13. Ileus; 14. Bowel leakage; 15. Reoperation; 16. Patient adaptation; 17. Length of hospital stay; 18. Colorectal anastomotic dehiscence; 19. Incisional hernia; 20. Postoperative bowel obstruction.