TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: The rate of operative deliveries (both caesarean sections, vacuum extractions and forceps), continues to rise throughout the world. These are associated with significant maternal and neonatal morbidity. The most common reasons for operative births in nulliparous women are labour dystocia (failure to progress), and non-reassuring fetal status. Epidural analgesia has been shown to slow the progress of labour, as well as increase the rate of instrumental deliveries. However, it is unclear whether the use of oxytocin in women with epidural analgesia results in a reduction in operative deliveries, and thereby reduces both maternal and fetal morbidity.
Objectives: To determine whether augmentation of women using epidural analgesia with oxytocin will decrease the incidence of operative deliveries and thereby reduce fetal and maternal morbidity.
Selection criteria: All published and unpublished randomised and quasi-randomised trials that compared augmentation with oxytocin of women in spontaneous labour with epidural analgesia versus intent to manage expectantly were included. Cluster-randomised trials were eligible for inclusion but none were identified.Cross-over study designs were unlikely to be relevant for this intervention, and we planned to exclude them if any were identified. We did not include results that were only available in published abstracts.
Background: Policies for timing of cord clamping vary, with early cord clamping generally carried out in the first 60 seconds after birth, whereas later cord clamping usually involves clamping the umbilical cord more than one minute after the birth or when cord pulsation has ceased. The benefits and potential harms of each policy are debated.
Objectives: To determine the effects of early cord clamping compared with late cord clamping after birth on maternal and neonatal outcomes
Selection criteria: Randomised controlled trials comparing early and late cord clamping.
Background: Patients with prosthetic heart valves are at increased risk for valve thrombosis and arterial thromboembolism. Oral anticoagulation alone, or the addition of antiplatelet drugs, has been used to minimise this risk. An important issue is the effectiveness and safety of the latter strategy.
Objectives: This is an update of our previous review; the goal was to create a valid synthesis of all available, methodologically sound data to further assess the safety and efficacy of combined oral anticoagulant and antiplatelet therapy versus oral anticoagulant monotherapy in patients with prosthetic heart valves.
Selection criteria: All reports of randomised controlled trials comparing standard-dose oral anticoagulation to standard-dose oral anticoagulation and antiplatelet therapy in patients with one or more prosthetic heart valves.
Background: For a long time pelvic floor muscle training (PFMT) has been the most common form of conservative (non-surgical) treatment for stress urinary incontinence (SUI). Weighted vaginal cones can be used to help women to train their pelvic floor muscles. Cones are inserted into the vagina and the pelvic floor is contracted to prevent them from slipping out.
Objectives: The objective of this review is to determine the effectiveness of vaginal cones in the management of female urinary stress incontinence (SUI).We wished to test the following comparisons in the management of stress incontinence: 1. vaginal cones versus no treatment; 2. vaginal cones versus other conservative therapies, such as PFMT and electrostimulation; 3. combining vaginal cones and another conservative therapy versus another conservative therapy alone or cones alone; 4. vaginal cones versus non-conservative methods, for example surgery or injectables.Secondary issues which were considered included whether:1. it takes less time to teach women to use cones than it does to teach the pelvic floor exercise; 2. self-taught use is effective;3. the change in weight of the heaviest cone that can be retained is related to the level of improvement;4. subgroups of women for whom cone use may be particularly effective can be identified.
Selection criteria: Randomised or quasi-randomised controlled trials comparing weighted vaginal cones with alternative treatments or no treatment.
Background: Ovarian cancer is the eighth most common cancer in women and it is usually diagnosed at an advanced stage. The majority of ovarian tumours are epithelial in origin. Women with relapsed epithelial ovarian cancer (EOC) often have a reduced performance status with a limited life expectancy, therefore maintaining quality of life with effective symptom control is the main purpose of treatment. Drug treatment of relapsed disease is directed by the platinum-free interval: relapsed platinum-sensitive disease is usually re-treated with platinum-based therapy and platinum-resistant disease challenged with non-platinum drugs. However, the side-effects of chemotherapy agents may be severe and optimal treatment regimens are unclear. Pegylated liposomal doxorubicin (PLD), which contains a cytotoxic drug called doxorubicin hydrochloride is one of several treatment modalities that may be considered for single-agent treatment of relapsed EOC, or used in combination with other drugs.
Objectives: To assess the efficacy and safety of PLD in women with relapsed epithelial ovarian cancer (EOC).
Selection criteria: Randomised controlled trials (RCTs) that evaluated PLD in women diagnosed with relapsed epithelial ovarian cancer.
Background: Fractures of the mandible (lower jaw) are a common occurrence and usually related to interpersonal violence or road traffic accidents. Mandibular fractures may be treated using open (surgical) and closed (non-surgical) techniques. Fracture sites are immobilized with intermaxillary fixation (IMF) or other external or internal devices (i.e. plates and screws) to allow bone healing. Various techniques have been used, however uncertainty exists with respect to the specific indications for each approach.
Objectives: The objective of this review is to provide reliable evidence of the effects of any interventions either open (surgical) or closed (non-surgical) that can be used in the management of mandibular fractures, excluding the condyles, in adult patients.
Selection criteria: Randomised controlled trials evaluating the management of mandibular fractures without condylar involvement. Any studies that compared different treatment approaches were included.
Background: Anthracycline-containing regimens (ACR) are the most prevalent regimens in the management of patients with advanced follicular lymphoma (FL). However, there is no proof that they are superior to non-anthracycline-containing regimens (non-ACR).
Objectives: To compare the efficacy of ACRs to other chemotherapy regimens, in the treatment of FL.
Selection criteria: We included randomized controlled trials (RCTs) comparing ACR with non-ACR for adult patients with FL. We excluded trials in which immunotherapy, radiotherapy alone or stem-cell transplantation were used in one arm alone. Our primary outcome was overall survival (OS). Secondary outcomes included disease control, as measured by progression-free survival (PFS) or remission duration (RD).
Background: Achieving informed consent is a core clinical procedure and is required before any surgical or invasive procedure is undertaken.  However, it is a complex process which requires patients be provided with information which they can understand and retain, opportunity to consider their options, and to be able to express their opinions and ask questions.  There is evidence that at present some patients undergo procedures without informed consent being achieved.
Objectives: To assess the effects on patients, clinicians and the healthcare system of interventions to promote informed consent for patients undergoing surgical and other invasive healthcare treatments and procedures.
Selection criteria: Randomised controlled trials and cluster randomised trials of interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. We considered an intervention to be intended to promote informed consent when information delivery about the procedure was enhanced (either by providing more information or through, for example, using new written materials), or if more opportunity to consider or deliberate on the information was provided.
Background: Infection with enterotoxigenic Escherichia coli (ETEC) bacteria is a common cause of diarrhoea in adults and children in developing countries and is a major cause of 'travellers' diarrhoea' in people visiting or returning from endemic regions. A killed whole cell vaccine (Dukoral®), primarily designed and licensed to prevent cholera, has been recommended by some groups to prevent travellers' diarrhoea in people visiting endemic regions. This vaccine contains a recombinant B subunit of the cholera toxin that is antigenically similar to the heat labile toxin of ETEC. This review aims to evaluate the clinical efficacy of this vaccine and other vaccines designed specifically to protect people against diarrhoea caused by ETEC infection.
Objectives: To evaluate the efficacy, safety, and immunogenicity of vaccines for preventing ETEC diarrhoea.
Selection criteria: Randomized controlled trials (RCTs) and quasi-RCTs comparing use of vaccines to prevent ETEC with use of no intervention, a control vaccine (either an inert vaccine or a vaccine normally given to prevent an unrelated infection), an alternative ETEC vaccine, or a different dose or schedule of the same ETEC vaccine in healthy adults and children living in endemic regions, intending to travel to endemic regions, or volunteering to receive an artificial challenge of ETEC bacteria.
Background: Preventing active tuberculosis (TB) from developing in people with latent tuberculosis infection (LTBI) is important for global TB control. Isoniazid (INH) for six to nine months has 60% to 90% protective efficacy, but the treatment period is long, liver toxicity is a problem, and completion rates outside trials are only around 50%. Rifampicin or rifamycin-combination treatments are shorter and may result in higher completion rates.
Objectives: To compare the effects of rifampicin monotherapy or rifamycin-combination therapy versus INH monotherapy for preventing active TB in HIV-negative people at risk of developing active TB.
Selection criteria: Randomized controlled trials (RCTs) of HIV-negative adults and children at risk of active TB treated with rifampicin, or rifamycin-combination therapy with or without INH (any dose or duration), compared with INH for six to nine months.
Background: There is no consensus regarding whether the peritoneum should be closed or left open during non-obstetric operations involving laparotomy. Neither is there consensus about the method of closure of the peritoneum (continuous suture versus interrupted suture). If closing the peritoneum could be omitted without complications, or even with benefit for patients, this could result in reductions in the cost of abdominal operations by reducing both the number of sutures used and the operating time.
Objectives: To compare the benefits and harms of parietal peritoneal closure compared with no parietal peritoneal closure in patients undergoing non-obstetric abdominal operations.
Selection criteria: We included only randomised controlled trials (RCTs) comparing peritoneal closure with no peritoneal closure in patients (adults and children) undergoing non-obstetric abdominal operations. All relevant RCTs irrespective of language, publication status, publication year, or sample size were included in the analysis.
Background: Patients undergoing vascular surgery are a high-risk population with widespread atherosclerosis, an adverse cardiovascular risk profile and often multiple co-morbidities. Postoperative cardiovascular complications, including myocardial infarct (MI), are common. Statins are the medical treatment of choice to reduce high cholesterol levels. Evidence is accumulating that patients taking statins at the time of surgery are protected against a range of perioperative complications, but the specific benefits for patients undergoing noncardiac vascular surgery are not clear.
Objectives: We examined whether short-term statin therapy, commenced before or on the day of noncardiac vascular surgery and continuing for at least 48 hours afterwards, improves patient outcomes including the risk of complications, pain, quality of life and length of hospital stay. We also examined whether the effect of statin therapy on these outcomes changes depending on the dose of statin received.
Selection criteria: We included RCTs that had compared short-term statin therapy, either commenced de novo or with existing users randomly assigned to different dosages, in adult participants undergoing elective and emergency noncardiac arterial surgery, including both open and endovascular procedures. We defined short-term as commencing before or on the day of surgery and continuing for at least 48 hours afterwards.
Background: Urinary tract infections account for about 40% of hospital-acquired (nosocomial) infections, and about 80% of urinary tract infections acquired in hospital are associated with urinary catheters.
Objectives: To determine if certain antibiotic prophylaxes are better than others in terms of prevention of urinary tract infections, complications, quality of life and cost-effectiveness in short-term catheterisation in adults.
Selection criteria: All randomised and quasi-randomised trials comparing antibiotic prophylaxis for short-term (up to and including 14 days) catheterisation in adults.
Background: Several drugs have been used in attenuating or obliterating the response associated with laryngoscopy and tracheal intubation. These changes are of little concern in relatively healthy patients but can lead to morbidity and mortality in the high risk patient population.
Objectives: The primary objective of this review was to determine the effectiveness of pharmacological agents in preventing the morbidity and mortality resulting from the haemodynamic changes in response to laryngoscopy and tracheal intubation in adult patients aged 18 years and above who were undergoing elective surgery in the operating room setting.
Selection criteria: We included randomized controlled trials (RCTs) that compared a drug used as an intervention for preventing or attenuating the haemodynamic response to tracheal intubation to a control group, and that mentioned mortality, major morbidity, arrhythmia or electrocardiogram (ECG) evidence of ischaemia in the methodology, results, or discussion section of the reports.
Background: Faecal incontinence is a debilitating problem with significant medical, social and economic implications. Treatment options include conservative, non-operative interventions (for example pelvic floor muscle training, biofeedback, drugs) and surgical procedures. A surgical procedure may be aimed at correcting an obvious mechanical defect, or augmenting a functionally deficient but structurally intact sphincter complex.
Objectives: To assess the effects of surgical techniques for the treatment of faecal incontinence in adults who do not have rectal prolapse. Our aim was firstly to compare surgical management with non-surgical management and secondly, to compare the various surgical techniques.
Selection criteria: All randomised or quasi-randomised trials of surgery in the management of adult faecal incontinence (other than surgery for rectal prolapse).
Background: This is an update of a Cochrane review first published in The Cochrane Library in Issue 1, 2006 and previously updated in 2009.Idiopathic sudden sensorineural hearing loss (ISSHL) is a clinical diagnosis characterised by a sudden deafness of cochlear or retrocochlear origin in the absence of a clear precipitating cause. Steroids are commonly prescribed to treat this condition. There is no consensus on their effectiveness.
Objectives: To determine whether steroids in the treatment of ISSHL a) improve hearing (primary) and b) reduce tinnitus (secondary).To determine the incidence of significant side effects from the medication.
Selection criteria: We identified all randomised controlled trials (with or without blinding) in which steroids were evaluated in comparison with either no treatment or a placebo. We considered trials including the use of steroids in combination with another treatment if the comparison control group also received the same other treatment. The two authors reviewed the full-text articles of all the retrieved trials of possible relevance and applied the inclusion criteria independently.
Background: Autopsy studies suggest that Wernicke-Korsakoff syndrome (WKS) is not a rare disorder, particularly in individuals who abuse alcohol. Thiamine has been established as the treatment of choice for over 50 years, but uncertainty remains about appropriate dosage and duration. Current practice guidelines are based on case reports and clinical experience. This is an update of a review first published in 2004 and last updated in 2008.
Objectives: • To assess the efficacy of thiamine in preventing and treating the manifestations of WKS due to excess alcohol consumption. • To determine the optimum form, dose and duration of thiamine treatment for this indication.
Selection criteria: Any randomised trials comparing thiamine with alternative interventions or comparing different thiamine regimens (varying in formulation, dose or duration of administration).
Background: Acetaminophen is frequently prescribed for treating patients with the common cold, but there is little evidence as to whether it is effective.
Objectives: To determine the efficacy and safety of acetaminophen in the treatment of the common cold in adults.
Selection criteria: We included randomised controlled trials (RCTs) comparing acetaminophen to placebo or no treatment in adults with the common cold. Studies were included if the trials used acetaminophen as one ingredient of a combination therapy. We excluded studies in which the participants had complications. Primary outcomes included subjective symptom score and duration of common cold symptoms. Secondary outcomes were overall well being, adverse events and financial costs.
Background: Postpartum haemorrhage (PPH) (bleeding from the genital tract after childbirth) is a major cause of maternal mortality and disability, particularly in under-resourced areas. In these settings, uterotonics are often not accessible. There is a need for simple, inexpensive techniques which can be applied in low-resourced settings to prevent and treat PPH. Uterine massage is recommended as part of the routine active management of the third stage of labour. However, it is not known whether it is effective. If shown to be effective, uterine massage would represent a simple intervention with the potential to have a major effect on PPH and maternal mortality in under-resourced settings.
Objectives: To determine the effectiveness of uterine massage after birth and before or after delivery of the placenta, or both, to reduce postpartum blood loss and associated morbidity and mortality.
Selection criteria: All published, unpublished and ongoing randomised controlled trials comparing uterine massage alone or in addition to uterotonics before or after delivery of the placenta, or both, with non-massage.
Background: Unilateral spatial neglect causes difficulty attending to one side of space. Various rehabilitation interventions have been used but evidence of their benefit is lacking.
Objectives: To assess whether cognitive rehabilitation improves functional independence, neglect (as measured using standardised assessments), destination on discharge, falls, balance, depression/anxiety and quality of life in stroke patients with neglect measured immediately post-intervention and at longer-term follow-up; and to determine which types of interventions are effective and whether cognitive rehabilitation is more effective than standard care or an attention control.
Selection criteria: We included randomised controlled trials (RCTs) of cognitive rehabilitation specifically aimed at spatial neglect. We excluded studies of general stroke rehabilitation and studies with mixed participant groups, unless more than 75% of their sample were stroke patients or separate stroke data were available.
Background: Uncomplicated biliary colic is one of the commonest indications for laparoscopic cholecystectomy. Laparoscopic cholecystectomy involves several months of waiting if performed electively. However, people can develop life-threatening complications during this waiting period.
Objectives: To assess the benefits and harms of early versus delayed laparoscopic cholecystectomy for people with uncomplicated biliary colic due to gallstones.
Selection criteria: We included only randomised clinical trials, irrespective of language and publication status.
Background: Continued controversy surrounds the optimal empirical treatment for febrile neutropenia. New broad-spectrum beta-lactams have been introduced as single treatment, and classically, a combination of a beta-lactam with an aminoglycoside has been used.
Objectives: To compare beta-lactam monotherapy versus beta-lactam-aminoglycoside combination therapy for cancer patients with fever and neutropenia.
Selection criteria: Randomised controlled trials (RCTs) comparing any beta-lactam antibiotic monotherapy with any combination of a beta-lactam and an aminoglycoside antibiotic, for the initial empirical treatment of febrile neutropenic cancer patients. All cause mortality was the primary outcome assessed.
Background: Epithelial ovarian cancer accounts for about 90% of all cases of ovarian cancer. Debulking surgery and six courses of platinum-based chemotherapy results in complete clinical remission (CCR) in up to 75% of cases. However, 75% of the responders will relapse within a median time of 18 to 28 months and only 20% to 40% of women will survive beyond five years. It has been suggested that maintenance chemotherapy could assist in prolonging remission. To date, there has not been a systematic review on the impact of maintenance chemotherapy for epithelial ovarian cancer.
Objectives: To assess the effectiveness and toxicity of maintenance chemotherapy for epithelial ovarian cancer and to evaluate the impact on quality of life (QoL).
Selection criteria: Randomised controlled trials (RCTs) comparing maintenance chemotherapy with no further intervention, maintenance radiotherapy or other maintenance therapy.
Background: Human African trypanosomiasis, or sleeping sickness, is a painful and protracted disease affecting people in the poorest parts of Africa and is fatal without treatment. Few drugs are currently available for second-stage sleeping sickness, with considerable adverse events and variable efficacy.
Objectives: To evaluate the effectiveness and safety of drugs for treating second-stage human African trypanosomiasis.
Selection criteria: Randomized and quasi-randomized controlled trials including adults and children with second-stage HAT, treated with anti-trypanosomal drugs.
Background: Haemoglobinopathies, inherited disorders of haemoglobin synthesis (thalassaemia) or structure (sickle cell disease), are responsible for significant morbidity and mortality throughout the world. The WHO estimates that, globally, 5% of adults are carriers of a haemoglobin condition, 2.9% are carriers of thalassaemia and 2.3% are carriers of sickle cell disease. Carriers are found worldwide as a result of migration of various ethnic groups to different regions of the world. Zinc is an easily available supplement and intervention programs have been carried out to prevent deficiency in people with thalassaemia or sickle cell anaemia. It is important to evaluate the role of zinc supplementation in the treatment of thalassaemia and sickle cell anaemia to reduce deaths due to complications.
Objectives: To assess the effect of zinc supplementation in the treatment of thalassaemia and sickle cell disease.
Selection criteria: Randomised, placebo-controlled trials of zinc supplements for treating thalassaemia or sickle cell disease administered at least once a week for at least a month.