TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Irritable bowel syndrome (IBS) is a common, costly, and difficult to treat disorder that impairs health-related quality of life and work productivity. Evidence-based treatment guidelines have been unable to provide guidance on the effects of acupuncture for IBS because the only previous systematic review included only small, heterogeneous and methodologically unsound trials.
Objectives: The primary objectives were to assess the efficacy and safety of acupuncture for treating IBS.
Selection criteria: Randomized controlled trials (RCTs) that compared acupuncture with sham acupuncture, other active treatments, or no (specific) treatment, and RCTs that evaluated acupuncture as an adjuvant to another treatment, in adults with IBS were included.
Background: Hospital at home schemes are a recently adopted method of service delivery for the management of acute exacerbations of chronic obstructive pulmonary disease (COPD) aimed at reducing demand for acute hospital inpatient beds and promoting a patient-centred approach through admission avoidance. However, evidence in support of such a service is contradictory.
Objectives: To evaluate the efficacy of hospital at home compared to hospital inpatient care in acute exacerbations of COPD.
Selection criteria: We considered randomised controlled trials where patients presented to the emergency department with an exacerbation of their COPD. Studies must not have recruited patients for whom treatment at home is usually not viewed as an responsible option (e.g. patients with an impaired level of consciousness, acute confusion, acute changes on the radiograph or electrocardiogram, arterial pH less than 7.35, concomitant medical conditions).
Background: Mother-infant separation postbirth is common in Western culture. Early skin-to-skin contact (SSC) begins ideally at birth and involves placing the naked baby, head covered with a dry cap and a warm blanket across the back, prone on the mother's bare chest. According to mammalian neuroscience, the intimate contact inherent in this place (habitat) evokes neurobehaviors ensuring fulfillment of basic biological needs. This time may represent a psychophysiologically 'sensitive period' for programming future physiology and behavior.
Objectives: To assess the effects of early SSC on breastfeeding, physiological adaptation, and behavior in healthy mother-newborn dyads.
Selection criteria: Randomized controlled trials comparing early SSC with usual hospital care.
Background: Anti-leukotrienes (5-lipoxygenase inhibitors and leukotriene receptors antagonists) serve as alternative monotherapy to inhaled corticosteroids (ICS) in the management of recurrent and/or chronic asthma in adults and children.
Objectives: To determine the safety and efficacy of anti-leukotrienes compared to inhaled corticosteroids as monotherapy in adults and children with asthma and to provide better insight into the influence of patient and treatment characteristics on the magnitude of effects.
Selection criteria: We included randomised trials that compared anti-leukotrienes with inhaled corticosteroids as monotherapy for a minimum period of four weeks in patients with asthma aged two years and older.
Background: Reduction and modification of dietary fats have differing effects on cardiovascular risk factors (such as serum cholesterol), but their effects on important health outcomes are less clear.
Objectives: To assess the effect of reduction and/or modification of dietary fats on mortality, cardiovascular mortality, cardiovascular morbidity and individual outcomes including myocardial infarction, stroke and cancer diagnoses in randomised clinical trials of at least 6 months duration.
Selection criteria: Trials fulfilled the following criteria: 1) randomised with appropriate control group, 2) intention to reduce or modify fat or cholesterol intake (excluding exclusively omega-3 fat interventions), 3) not multi factorial, 4) adult humans with or without cardiovascular disease, 5) intervention at least six months, 6) mortality or cardiovascular morbidity data available.
Background: Despite differences in how it is defined, there is a general consensus amongst clinicians and researchers that the sexual abuse of children and adolescents ('child sexual abuse') is a substantial social problem worldwide. The effects of sexual abuse manifest in a wide range of symptoms, including fear, anxiety, post-traumatic stress disorder and various externalising and internalising behaviour problems, such as inappropriate sexual behaviours. Child sexual abuse is associated with increased risk of psychological problems in adulthood. Cognitive-behavioural approaches are used to help children and their non-offending or 'safe' parent to manage the sequelae of childhood sexual abuse. This review updates the first Cochrane review of cognitive-behavioural approaches interventions for children who have been sexually abused, which was first published in 2006.
Objectives: To assess the efficacy of cognitive-behavioural approaches (CBT) in addressing the immediate and longer-term sequelae of sexual abuse on children and young people up to 18 years of age.
Selection criteria: We included randomised or quasi-randomised controlled trials of CBT used with children and adolescents up to age 18 years who had experienced being sexually abused, compared with treatment as usual, with or without placebo control.
Background: Epilepsy is a common neurological condition, affecting almost 0.5 to 1% of the population. Nearly 30% of people with epilepsy are resistant to currently available drugs. Tiagabine is one of the newer antiepileptic drugs and its effects as an adjunct (add-on) to standard drugs are assessed in this review.
Objectives: To evaluate the effects of add-on treatment with tiagabine upon seizures, adverse effects, cognition and quality of life for people with drug-resistant localisation related seizures.
Selection criteria: Randomised placebo controlled add-on trials of people of any age with localisation related seizures, in which an adequate method of concealment of randomisation was used were included. The studies could be double, single or unblinded and be of parallel or crossover design. They had to have a minimum treatment period of eight weeks. Trials using an active drug control group were also included.
Background: A particularly difficult challenge for community treatment of people with serious mental illnesses is the delivery of an acceptable level of care during the acute phases of severe mental illness. Crisis intervention models of care were developed as a possible solution.
Objectives: To review the effects of crisis intervention models for anyone with serious mental illness experiencing an acute episode, compared with 'standard care'.
Selection criteria: We included all randomised controlled trials of crisis intervention models versus standard care for people with severe mental illnesses.
Background: Cigarette smoking is one of the leading causes of preventable death world wide. There is good evidence that brief interventions from health professionals can increase smoking cessation attempts. A number of trials have examined whether skills training for health professionals can lead them to have greater success in helping their patients who smoke.
Objectives: To determine the effectiveness of training health care professionals in the delivery of smoking cessation interventions to their patients, and to assess the additional effects of training characteristics such as intervention content, delivery method and intensity.
Selection criteria: Randomized trials in which the intervention was training of health care professionals in smoking cessation. Trials were considered if they reported outcomes for patient smoking at least six months after the intervention. Process outcomes needed to be reported, however trials that reported effects only on process outcomes and not smoking behaviour were excluded.
Background: Fibromyalgia (FM) syndrome is a chronic condition of unknown aetiology characterised by musculoskeletal pain that often co-exists with sleep disturbance, cognitive dysfunction and fatigue. Patients often report high disability levels and poor quality of life. Since there is no specific treatment that alters the pathogenesis of FM, drug therapy focuses on pain reduction and improvement of other bothersome symptoms.
Objectives: The objective of this review was to assess the effectiveness and safety of monoamine oxidase inhibitors (MAOIs) in the treatment of FM syndrome.
Selection criteria: We selected all randomised, double-blind trials of MAOIs used for the treatment of FM pain in adult participants.
Background: Allergic rhinitis is a disorder of the nasal membranes and surrounding tissues, and a worldwide cause of illness and disability. Helminths are complex tissue-dwelling or lumen-dwelling organisms that inhabit larger organisms and are frequently asymptomatic. Helminths modulate the natural immune responses of their human hosts, and may prevent or cure immune-mediated or allergic diseases (e.g. allergic rhinitis) in the host. Non-randomised studies support this hypothesis.
Objectives: To assess the safety and effectiveness of helminth therapy in people with allergic rhinitis.
Selection criteria: All randomised controlled trials where the intervention was any helminth species or combination of helminth species, administered to people with allergic rhinitis in any dose, by any route and for any duration of exposure. We accepted both intermittent and persistent allergic rhinitis patients.
Background: Local anaesthetic nerve block is an important modality for pain management in labour. Pudendal and paracervical block (PCB) are most commonly performed local anaesthetic nerve blocks which have been used for decades.
Objectives: To establish the efficacy and safety of local anaesthetic nerve blocks for pain relief in labour.
Selection criteria: We included randomised controlled trials (RCTs) assessing pain management in labour with the use of local anaesthetic nerve blocks. We did not include results from quasi-RCTs.
Background: Clinical observations indicate that mothers commonly perceive a reduction in, or absence of, the baby's movements for some days preceding a baby's death. For this reason, fetal movement monitoring is advised by caregivers and used spontaneously by mothers to assess the baby's well-being. However, it is possible that the harmful effects of interventions may outweigh the benefits of such testing. Evidence of effectiveness of fetal movement screening to improve outcomes is limited, though indirect evidence suggests a potential benefit. A secondary question is whether any specific management response to perceived decreased fetal movements (DFM) improves clinical outcome.
Objectives: To determine, from the best available evidence, the effectiveness of various management strategies for DFM.
Selection criteria: Randomised clinical trials comparing various management strategies for DFM, including delivery, expectant management, cardiotocography (visual and computerised), ultrasound examination including Doppler ultrasound, and fetal arousal tests (cardiotocographic or clinical).
Background: Long-acting bronchodilators comprising long-acting beta(2)-agonists and the anticholinergic agent tiotropium are commonly used for managing persistent symptoms of chronic obstructive pulmonary disease. Combining these treatments, which have different mechanisms of action, may be more effective than the individual components. However, the benefits and risks of combining tiotropium and long-acting beta(2)-agonists for the treatment of chronic obstructive pulmonary (COPD) disease are unclear.
Objectives: To assess the relative effects of treatment with tiotropium in addition to long-acting beta(2)-agonist compared to tiotropium or long-acting beta(2)-agonist alone in patients with chronic obstructive pulmonary disease.
Selection criteria: We included parallel group, randomised controlled trials of three months or longer comparing treatment with tiotropium in addition to long-acting beta(2)-agonist against tiotropium or long-acting beta(2)-agonist alone for patients with chronic obstructive pulmonary disease.
Background: Cognitive behavioural therapy (CBT) is now a recommended treatment for people with schizophrenia. This approach helps to link the person's distress and problem behaviours to underlying patterns of thinking.
Objectives: To review the effects of CBT for people with schizophrenia when compared with other psychological therapies.
Selection criteria: All relevant randomised controlled trials (RCTs) of CBT for people with schizophrenia-like illnesses.
Background: Shoulder dysfunction is a common problem in patients treated for head and neck cancer. Both neck dissections and radiotherapy can cause morbidity to the shoulder joint. Exercise interventions have been suggested as a treatment option for this population.
Objectives: To evaluate the effectiveness and safety of exercise interventions for the treatment of shoulder dysfunction caused by the treatment of head and neck cancer.
Selection criteria: Randomized controlled trials (RCTs) comparing any type of exercise therapy compared with any other intervention in patients with shoulder dysfunction due to treatment of head and neck cancer.
Background: An incomplete miscarriage occurs when all the products of conception are not expelled through the cervix. Curettage or vacuum aspiration have been used to remove retained tissues. The anaesthetic techniques used to facilitate this procedure have not been systematically evaluated in order to determine which provide better outcomes to the patients.
Objectives: To assess the effects of general anaesthesia, sedation or analgesia, regional or paracervical block anaesthetic techniques, or differing regimens of these, for surgical evacuation of incomplete miscarriage.
Selection criteria: All published and unpublished randomised controlled trials (RCTs) or cluster-RCTs comparing the use of any anaesthetic technique (defined by authors as general anaesthesia, sedation/analgesia, regional or paracervical local block (PCB) procedures) to perform surgical evacuation of an incomplete miscarriage. We excluded quasi-randomised trials and studies that were only available as abstracts.
Background: Benign paroxsymal positional vertigo (BPPV) is a syndrome characterised by short-lived episodes of vertigo associated with rapid changes in head position. It is a common cause of vertigo presenting to primary care and specialist otolaryngology (ENT) clinics. BPPV of the posterior canal is a specific type of BPPV for which the Epley (canalith repositioning) manoeuvre is a verified treatment. A range of modifications of the Epley manoeuvre are used in clinical practice, including post-Epley vestibular exercises and post-Epley postural restrictions.
Objectives: To assess whether the various modifications of the Epley manoeuvre for posterior canal BPPV enhance its efficacy in clinical practice.
Selection criteria: Randomised controlled trials of modifications of the Epley manoeuvre versus a standard Epley manoeuvre as a control in adults with posterior canal BPPV diagnosed with a positive Dix-Hallpike test. Specific modifications sought were: application of vibration/oscillation to the mastoid region, vestibular rehabilitation exercises, additional steps in the Epley manoeuvre and post-treatment instructions relating to movement restriction.
Background: Cancer cachexia is a multidimensional syndrome characterised by wasting, loss of weight, loss of appetite, metabolic alterations, fatigue and reduced performance status. A significant number of patients with advanced cancer develop cachexia before death. There is no identified optimum treatment for cancer cachexia. While the exact mechanism of the action of thalidomide is unclear, it is known to have immunomodulatory and anti-inflammatory properties, which are thought to help reduce the weight loss associated with cachexia. Preliminary studies of thalidomide have demonstrated encouraging results.
Objectives: This review aimed to (1) evaluate the effectiveness of thalidomide, and (2) identify and assess adverse effects from thalidomide for cancer cachexia.
Selection criteria: This review included randomised controlled trials (RCTs) and non-RCTs. Participants were adults diagnosed with advanced or incurable cancer and weight loss or a clinical diagnosis of cachexia who were administered thalidomide.
Background: Fermented milk has been suggested to have a blood pressure lowering effect through increased content of proteins and peptides produced during the bacterial fermentation. Hypertension is one of the major risk factors for cardiovascular disease world wide and new blood pressure reducing lifestyle interventions, such as fermented milk, would be of great importance.
Objectives: To investigate whether fermented milk or similar products produced by lactobacilli fermentation of milk proteins has any blood pressure lowering effect in humans when compared to no treatment or placebo.
Selection criteria: Randomised controlled trials; cross over and parallel studies evaluating the effect on blood pressure of fermented milk in humans with an intervention period of 4 weeks or longer.
Background: Dislocation of the elbow joint is a relatively uncommon injury.
Objectives: To assess the effects of various forms of treatment for acute simple elbow dislocations in adults.
Selection criteria: Randomised or quasi-randomised controlled trials of conservative and surgical treatment of dislocations of the elbow in adults. Excluded were trials involving dislocations with associated fractures, except for avulsion fractures.
Background: Osteoarthritis (OA) is the most common form of arthritis of the temporomandibular joint (TMJ), and can often lead to severe pain in the orofacial region. Management options for TMJ OA include reassurance, occlusal appliances, physical therapy, medication in addition to several surgical modalities.
Objectives: To investigate the effects of different surgical and non-surgical therapeutic options for the management of TMJ OA in adult patients.
Selection criteria: Randomised controlled trials (RCTs) comparing any form of non-surgical or surgical therapy for TMJ OA in adults over the age of 18 with clinical and/or radiological diagnosis of TMJ OA according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) guideline or compatible criteria.Primary outcomes considered were pain/tenderness/discomfort in the TMJs or jaw muscles, self assessed range of mandibular movement and TMJ sounds. Secondary outcomes included the measurement of quality of life or patient satisfaction evaluated with a validated questionnaire, morphological changes of the TMJs assessed by imaging, TMJ sounds assessed by auscultation and any adverse effects.
Background: Excessive weight gain during pregnancy is associated with multiple maternal and neonatal complications. However, interventions to prevent excessive weight gain during pregnancy have not been adequately evaluated.
Objectives: To evaluate the effectiveness of interventions for preventing excessive weight gain during pregnancy and associated pregnancy complications.
Selection criteria: All randomised controlled trials and quasi-randomised trials of interventions for preventing excessive weight gain during pregnancy.
Background: Central venous catheters (CVCs) facilitate the administration of intravenous drugs, fluids, blood products and parenteral nutrition to patients with either chronic disease or critical illness. Despite a pivotal role within medical management, a common complication associated with CVC use is occlusion of the CVC lumen(s). CVC occlusion can interrupt and cause serious delays in administration of treatment interventions.
Objectives: The primary objective of this review was to assess the efficacy and safety of different interventions used to restore patency of occluded CVC lumens, in adults and children.
Selection criteria: We selected randomized controlled trials which investigated the efficacy of an intervention (chemical, surgical or drug) used to restore patency to an occluded CVC lumen, in either adults or children.
Background: Atrial fibrillation (AF) is the most common cardiac arrhythmia seen in cardiovascular departments. Treatments include medical interventions and catheter ablation. Due to uncertainties in medical therapies for AF, and the need to continue sinus rhythm, ablation has been recently considered as a viable alternative. Many new ablation methods based on pulmonary vein isolation (PVI) have been developed.
Objectives: The primary objective of this review was to assess the beneficial and harmful effects of catheter ablation (CA) in comparison with medical treatment in patients with paroxysmal and persistent AF. The secondary objective was to determine the best regimen of CA.
Selection criteria: Randomised controlled trials (RCTs) in people with paroxysmal and persistent AF treated by any type of CA method. Two reviewers independently selected the trials for inclusion.
Background: Patellofemoral pain syndrome refers to the clinical presentation of knee pain related to changes in the patellofemoral joint. Patellofemoral pain syndrome usually has a gradual onset of pain with none of the features associated with other knee diseases or trauma. It is often treated by physiotherapists, who use a variety of techniques including patellar taping. This involves the application of adhesive sports medical tape applied directly to the skin over the patella on the front of the knee. Patients often report an instantaneous improvement in pain and function after the tape is applied, but its longer term effects are uncertain.
Objectives: The objective was to assess the effects, primarily on pain and function, of patellar taping for treating patellofemoral pain syndrome in adults.
Selection criteria: Randomised controlled trials and quasi-randomised controlled trials testing the effects of patellar taping on clinically relevant outcomes, pain and function, in adults with patellofemoral pain syndrome. We excluded studies testing only the immediate effects of tape application.
Background: Approximately one-fifth of women who develop early breast cancer have HER2-positive tumours, which if untreated, have a worse prognosis than HER2-negative tumours. Trastuzumab is a selective treatment targeting the HER2 pathway. Although the results on efficacy seem to support its use, there are potential cardiac toxicities which need to be considered, especially for women at lower risk of recurrence, or those at increased cardiovascular risk.
Objectives: To assess the evidence on the efficacy and safety of therapy with trastuzumab, overall and in relation to its duration, concurrent or sequential administration with the standard chemotherapy regimen in patients with HER2-positive early breast cancer.
Selection criteria: RCTs comparing the efficacy and safety of trastuzumab alone, or in combination with chemotherapy, or no treatment, or standard chemotherapy alone, in women with HER2-positive early breast cancer including women with locally advanced breast cancer.
Background: Advantages to combining childhood vaccines include reducing the number of visits, injections and patient discomfort, increasing compliance and optimising prevention. The World Health Organization (WHO) recommends that routine infant immunisation programmes include a vaccination against Haemophilus influenzae (H. influenzae) type B (HIB) in the combined diphtheria-tetanus-pertussis (DTP)-hepatitis B virus (HBV) vaccination. The effectiveness and safety of the combined vaccine should be carefully and systematically assessed to ensure its acceptability by the community.
Objectives: To compare the effectiveness of combined DTP-HBV-HIB vaccines versus combined DTP-HBV and separate HIB vaccinations.
Selection criteria: Randomised controlled trials (RCTs) or quasi-RCTs comparing vaccination with any combined DTP-HBV-HIB vaccine, with or without three types of inactivated polio virus (IPV) or concomitant oral polio vaccine (OPV) in any dose, preparation or time schedule, compared with separate vaccines or placebo, administered to infants up to two years old.