TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: A malaria vaccine is needed because of the heavy burden of mortality and morbidity due to this disease. This review describes the results of trials of blood (asexual)-stage vaccines. Several are under development, but only one (MSP/RESA, also known as Combination B) has been tested in randomized controlled trials.
Objectives: To assess the effect of blood-stage malaria vaccines in preventing infection, disease, and death.
Selection criteria: Randomized controlled trials comparing blood-stage vaccines (other than SPf66) against P. falciparum, P. vivax, P. malariae, or P. ovale with placebo, control vaccine, or routine antimalarial control measures in people of any age receiving a challenge malaria infection.
Background: Vaccines against all stages of the malaria parasite are in development, mainly for Plasmodium falciparum, which causes the most serious form of malaria. Pre-erythrocytic vaccines act to prevent or delay a malaria attack by attacking the sporozoite and liver stages before the parasite reaches the bloodstream.
Objectives: To assess the efficacy and safety of pre-erythrocytic malaria vaccines against any type of human malaria.
Selection criteria: Randomized controlled trials comparing pre-erythrocytic vaccines with placebo, control vaccine, or routine antimalarial control measures in people of any age receiving an artificial challenge or natural exposure to malaria infection.
Background: This review is one in a series of Cochrane reviews of interventions for shoulder pain in adults.
Objectives: To determine the efficacy and safety of oral steroids for adhesive capsulitis.
Selection criteria: Only studies described as randomised controlled trials studying participants with adhesive capsulitis, frozen shoulder, stiff painful shoulder or periarthritis and interventions of oral steroids compared to placebo, no treatment, or any other treatment were included.
Background: In the past, progesterone has been advocated for prevention of pre-eclampsia and its complications. Although progestogens are not used for this purpose in current clinical practice, it remains relevant to assess the evidence on their possible benefits and harms.
Objectives: To assess the effects of progesterone during pregnancy on the risk of developing pre-eclampsia and its complications.
Selection criteria: Randomised trials evaluating progesterone or any other progestogen during pregnancy for prevention of pre-eclampsia and its complications were included.
Background: Worldwide, the prevalence of obesity and overweight in industrialized countries and in a substantial number of developing countries is increasing at an alarming rate. Rimonabant is a selective cannabinoid-1 receptor antagonist that has been investigated for its efficacy in reducing body weight and associated risk factors in obese people. Phase III trials are now under way to test the use of rimonabant for long-term weight-loss. Given the prevalence of overweight and obesity, it is important to establish the efficacy and safety of rimonabant.
Objectives: To assess the effects of rimonabant in overweight and obese people.
Selection criteria: Randomised controlled trials comparing rimonabant with placebo or other weight loss interventions in overweight or obese adults.
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 newer peroxisome proliferator activated receptor gamma (PPAR-gamma) activators like pioglitazone 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 pioglitazone 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: Heavy bleeding and pain are the most common reasons why women discontinue IUDs. Non-steroidal anti-inflammatory drugs, which inhibit prostaglandin synthesis, have been shown to be effective in reducing menstrual bleeding and pain in women without IUDs.
Objectives: This review summarizes all randomized controlled trials studying use of nonsteroidal anti-inflammatory drugs for treatment of bleeding or pain associated with IUD use. Trials of prophylactic use of these drugs around the time of IUD insertion were also included.
Selection criteria: We included all randomized controlled trials in any language that tested one or more nonsteroidal anti-inflammatory drugs for treatment or prevention of bleeding or pain associated with IUD insertion or use.
Background: Hormone therapy for early prostate cancer has demonstrated an improvement in clinical and pathological variables, but not always an improvement in overall survival. We performed a systematic review of both adjuvant and neo-adjuvant hormone therapy combined with surgery or radiotherapy in localised or locally advanced prostate cancer.
Objectives: The objective of this review was to undertake a systematic review and, if possible, a meta-analysis of neo-adjuvant and adjuvant hormone therapy in localised or locally advanced prostate cancer.
Selection criteria: Randomised or quasi-randomised controlled trials of patients with localised or locally advanced prostate cancer, that is, stages T1-T4, any N, M0, comparing neo-adjuvant or adjuvant hormonal deprivation in combination with primary therapy (radical radiotherapy or radical prostatectomy) versus primary therapy alone were included in this review.
Background: The early management of shoulder dystocia involves the administration of various manoeuvres which aim to relieve the dystocia by manipulating the fetal shoulders and increasing the functional size of the maternal pelvis.
Objectives: To assess the effects of prophylactic manoeuvres in preventing shoulder dystocia.
Selection criteria: Randomised controlled trials comparing the prophylactic implementation of manoeuvres and maternal positioning with routine or standard care.
Background: Cardenolides are naturally occurring plant toxins which act primarily on the heart. While poisoning with the digitalis cardenolides (digoxin and digitoxin) are reported worldwide, cardiotoxicity from other cardenolides such as the yellow oleander are also a major problem, with tens of thousands of cases of poisoning each year in South Asia. Because cardenolides from these plants are structurally similar, acute poisonings are managed using similar treatments. The benefit of these treatments is of interest, particularly in the context of cost since most poisonings occur in developing countries where resources are very limited.
Objectives: To determine the efficacy of antidotes for the treatment of acute cardenolide poisoning, in particular atropine, isoprenaline (isoproterenol), multiple-dose activated charcoal (MDAC), fructose-1,6-diphosphate, sodium bicarbonate, magnesium, phenytoin and anti-digoxin Fab antitoxin.
Selection criteria: Randomised controlled trials where antidotes were administered to patients with acute symptomatic cardenolide poisoning were identified.
Background: Hemorrhoids are one of the most common anorectal disorders. The Milligan‐Morgan open hemorrhoidectomy is the most widely practiced surgical technique used for the management of hemorrhoids and is considered the current "gold standard". Circular stapled hemorrhoidopexy was first described by Longo in 1998 as alternative to conventional excisional hemorrhoidectomy. Early, small randomized‐controlled trials comparing stapled hemorrhoidopexy with traditional excisional surgery have shown it to be less painful and that it is associated with quicker recovery. The reports also suggest a better patient acceptance and a higher compliance with day‐case procedures potentially making it more economical. A previous Cochrane Review of stapled hemorrhoidopexy and conventional excisional surgery has shown that the stapled technique is associated with a higher risk of recurrent hemorrhoids and some symptoms in long term follow‐up. Since this initial review, several more randomized controlled trials have been published that may shed more light on the differences between the novel stapled approach and conventional excisional techniques.
Objectives: This review compares the use of circular stapling devices and conventional excisional techniques in the surgical treatment of hemorrhoids. Its goal is to ascertain whether there is any difference in the outcomes of the two techniques in patients with symptomatic hemorrhoids.
Selection criteria: All randomized controlled trials comparing stapled hemorrhoidopexy to conventional excisional hemorrhoidal surgeries with a minimum follow‐up period of 6 months were included.
Background: Acquired Antithrombin (AT) deficiency is a common and prognostically important finding in sick preterm infants with respiratory distress syndrome (RDS). It has been hypothesised that AT concentrate may improve clinical outcomes in preterm infants with RDS.
Objectives: To determine whether the administration of AT concentrate decreases mortality in preterm infants with RDS compared with placebo or no treatment.
Selection criteria: Randomized controlled trials comparing any dose and duration of AT therapy with placebo or no treatment in preterm infants with RDS.
Background: Strontium ranelate is a new treatment for osteoporosis therefore, its benefits and harms need to be known.
Objectives: To determine the efficacy and safety of strontium ranelate for the treatment and prevention of postmenopausal osteoporosis.
Selection criteria: We included randomized controlled trials (RCTs) of at least one year duration comparing strontium ranelate versus placebo reporting fracture incidence, bone mineral density (BMD), health related quality of life or safety in postmenopausal women. Treatment (versus prevention) population was defined as women with prevalent vertebral fractures and/or lumbar spine BMD T score < -2.5 SD.
Background: Continuous positive airway pressure (CPAP) is the mainstay of therapy for moderate to severe obstructive sleep apnoea (OSA). However, compliance with CPAP has been less than ideal. There are many different CPAP interfaces now available for the treatment of OSA. The type of CPAP delivery interface is likely to influence a patient's acceptance of CPAP therapy and long term compliance.
Objectives: This review aims to compare the efficacy of the various CPAP delivery interfaces available for the treatment of obstructive sleep apnoea.
Selection criteria: All randomised, controlled trials comparing different forms of CPAP delivery interface for the treatment of OSA were considered for inclusion.
Background: Most liver transplant recipients receive either cyclosporin or tacrolimus to prevent rejection. Both drugs inhibit calcineurin phosphatase which is thought to be the mechanism of their anti-rejection effect and principle toxicities. The drugs have different pharmacokinetic profiles and potencies. Several randomised clinical trials have compared cyclosporin and tacrolimus in liver transplant recipients, but it remains unclear which is superior.
Objectives: To evaluate the beneficial and harmful effects of immunosuppression with cyclosporin versus tacrolimus for liver transplanted patients.
Selection criteria: All randomised clinical trials where tacrolimus was compared with cyclosporin for the initial treatment of first-time liver transplant recipients. We included randomised trials irrespective of blinding, language, and publication status.
Background: Massage and touch have been suggested as a non-pharmacological alternative or supplement to other treatments offered in order to reduce or manage a range of conditions associated with dementia such as anxiety, agitated behaviour and depression. It has also been suggested that massage and touch may counteract cognitive decline.
Objectives: To assess the effects of a range of massage and touch therapies on conditions associated with dementia, such as anxiety, agitated behaviour and depression, identify any adverse effects, and provide recommendations about future trials.
Selection criteria: Randomized controlled trials (RCTs) in which a massage or touch intervention was given to persons suffering from dementia of any type, compared with other treatments or no treatment, and in which effect parameters included measures of behavioural problems, caregiver burden, emotional distress or cognitive abilities, were eligible for inclusion. Furthermore, we employed a set of minimal methodological quality criteria as a selection filter.
Background: Endoscopic balloon dilation was introduced as an alternative to endoscopic sphincterotomy to preserve the sphincter of Oddi and avoid undesirable effects due to an incompetent sphincter. Endoscopic balloon dilation has been largely abandoned by USA endoscopists due to increased risks of pancreatitis noted in one multicentre trial, but is still practiced in parts of Asia and Europe.
Objectives: To assess the beneficial and harmful effects of endoscopic balloon dilation versus endoscopic sphincterotomy in the management of common bile duct stones.
Selection criteria: Randomised clinical trials comparing endoscopic balloon dilation versus endoscopic sphincterotomy in removal of common bile duct stones irrespective of publication status, language, or blinding.
Background: Refractory ascites (ie, ascites that cannot be mobilized despite sodium restriction and diuretic treatment) occurs in 10 per cent of patients with cirrhosis. It is associated with substantial morbidity and mortality with a one-year survival rate of less than 50 per cent. Few therapeutic options currently exist for the management of refractory ascites.
Objectives: To compare transjugular intrahepatic portosystemic stent-shunts (TIPS) versus paracentesis for the treatment of refractory ascites in patients with cirrhosis.
Selection criteria: We included randomised clinical trials comparing TIPS and paracentesis with or without volume expanders for cirrhotic patients with refractory ascites.
Background: L-cysteine is thought to be a conditionally essential (i.e., essential under certain conditions) amino acid for neonates. It is a precursor of glutathione, an antioxidant that may reduce oxidation injury. The addition of cysteine to parenteral nutrition (PN) allows for the reduction of the amount of methionine in PN, thereby limiting hepatotoxicity, and acidifies the solution, thereby increasing calcium and phosphate solubility, and potentially improving bone mineralization.
Objectives: To determine the effects of supplementing parenteral nutrition with cysteine, cystine or its precursor N-acetylcysteine on neonatal growth and short and long-term outcomes.
Selection criteria: All randomized (RCTs) and quasi-randomized trials that examined the effects of cysteine, cystine or N-acetylcysteine supplementation of neonatal PN were reviewed. Predetermined outcome variables included growth, nitrogen retention, mortality, morbidity secondary to oxidation injury, bone accretion, acidosis, liver disease, and cysteine levels.
Background: While behavioural or cognitive-behavioural therapy (BT/CBT) is recommended as the psychotherapeutic treatment of choice for children and adolescents with obsessive-compulsive disorder (OCD), the application of BT/CBT to paediatric OCD may not be straightforward.
Objectives: This review examines the overall efficacy of BT/CBT for paediatric OCD, its relative efficacy against psychopharmacology and whether there are benefits in using BT/CBT combined with medication.
Selection criteria: Included studies were randomised controlled trials or quasi-randomised trials with participants who were 18 years of age or younger and had a diagnosis of OCD, established by clinical assessment or standardised diagnostic interview. Reviewed studies included the standard behavioural or cognitive-behavioural techniques, either alone or in combination, compared with wait-list or pill placebo.
Background: Cholecystectomy is one of the most frequently performed operations. Open cholecystectomy has been the gold standard for over 100 years. Small-incision cholecystectomy is a less frequently used alternative.
Objectives: To compare the beneficial and harmful effects of small-incision versus open cholecystectomy for patients with symptomatic cholecystolithiasis.
Selection criteria: All published and unpublished randomised trials in patients with symptomatic cholecystolithiasis comparing any kind of small-incision or other kind of minimal incision cholecystectomy versus any kind of open cholecystectomy. No language limitations were applied.
Background: It is known that many patients encounter a variety of problems in the first weeks after they have been discharged from hospital to home. In recent years many projects have addressed discharge planning, with the aim of reducing problems after discharge. Telephone follow-up (TFU) is seen as a good means of exchanging information, providing health education and advice, managing symptoms, recognising complications early, giving reassurance and providing quality aftercare service. Some research has shown that telephone follow-up is feasible, and that patients appreciate such calls. However, at present it is not clear whether TFU is also effective in reducing postdischarge problems.
Objectives: To assess the effects of follow-up telephone calls in the first month post discharge, initiated by hospital-based health professionals, to patients discharged from hospital to home.
Selection criteria: Randomised and quasi-randomised controlled trials of TFU initiated by a hospital-based health professional, for patients discharged home from an acute hospital setting. The intervention was delivered within the first month after discharge; outcomes were measured within 3 months after discharge, and either the TFU was the only intervention, or its effect could be analysed separately.
Background: Tongxinluo capsule is a medicine consisting of traditional Chinese herbs and insects used for cardiovascular diseases in China and some other Asian countries. To date the evidence of its effect has not previously been subject to systematic review, making it difficult to derive robust conclusions about its actual benefits, and indeed, possible harms.
Objectives: To assess systematically the effects of tongxinluo capsule in people with unstable angina pectoris.
Selection criteria: Randomised trials comparing either tongxinluo capsule only or standard treatment plus tongxinluo capsule with standard treatment or other anti-angina pectoris drugs, placebo or no intervention.
Background: Acute otitis media (AOM) is a common childhood illness. These middle ear infections may be frequent and painful. AOM may be associated with perforation of the tympanic membrane and can progress to chronic suppurative otitis media (CSOM).
Objectives: To determine the effectiveness of long-term antibiotics (for longer than six weeks) in preventing any AOM, AOM with perforation and CSOM.
Selection criteria: All randomised controlled trials of long-term (longer than six weeks) antibiotics versus placebo or no treatment for the prevention of AOM, AOM with perforation, or CSOM were eligible.
Background: A previous meta-analysis investigated the role of chemotherapy in head and neck locally advanced carcinoma. This work had not been performed on nasopharyngeal carcinoma.
Objectives: The aim of the project was to study the effect of adding chemotherapy to radiotherapy on overall survival (OS) and event-free survival (EFS) in patients with nasopharyngeal carcinoma.
Selection criteria: Randomised trials comparing chemotherapy plus radiotherapy to radiotherapy alone in locally advanced nasopharyngeal carcinoma were included.
Background: Kawasaki disease is the most common cause of acquired heart disease in children in developed countries. The coronary arteries supplying the heart can be damaged in Kawasaki disease. The principal advantage of timely diagnosis is the potential to prevent this complication with early treatment. Salicylate (acetyl salicylate acid (ASA), aspirin) and intravenous immunoglobulin (IVIG) are widely used for this purpose. Salicylate is largely otherwise avoided in children because of concerns about serious side effects, particularly the risk of Reyes syndrome.
Objectives: The objective of this review was to evaluate the effectiveness of salicylate in treating and preventing cardiac consequences of Kawasaki disease in children.
Selection criteria: Randomised controlled trials (RCTs) of salicylate to treat Kawasaki disease in children were eligible for inclusion.
Background: Clinical trials have shown that exercise in adults with overweight or obesity can reduce bodyweight. There has been no quantitative systematic review of this in The Cochrane Library.
Objectives: To assess exercise as a means of achieving weight loss in people with overweight or obesity, using randomised controlled clinical trials.
Selection criteria: Studies were included if they were randomised controlled trials that examined body weight change using one or more physical activity intervention in adults with overweight or obesity at baseline and loss to follow-up of participants of less than 15%.
Background: Around 16% of adults have symptoms of overactive bladder (urgency with frequency and/or urge incontinence). The prevalence increases with age. Anticholinergic drugs are commonly used to treat this condition.
Objectives: To determine the effects of anticholinergic drugs for the treatment of overactive bladder syndrome.
Selection criteria: Randomised or quasi-randomised trials in adults with overactive bladder syndrome that compared an anticholinergic drug with placebo treatment or no treatment.
Background: Colorectal cancer metastatic to the liver, when technically feasible, is resected with a moderate chance of cure. The most common site of failure after resection is within the remaining liver. With this pattern of clinical failure in mind and in order to enhance survival, chemotherapy has been delivered directly to the liver post resection via the hepatic artery.
Objectives: To assess the effect of post hepatic resection hepatic artery chemotherapy on overall survival. Secondary objectives include adverse events related to the chemotherapy, the risk of intra-hepatic tumour recurrence and tumour free survival.
Selection criteria: Trials in which patients having resection of colorectal cancer metastatic to the liver were randomised either to hepatic artery chemotherapy or any alternative treatment.
Background: Allergies and food reactions in infants and children are common and may be associated with a variety of foods including adapted cow's milk formula. Soy based formulas have been used to treat infants with allergy or food intolerance. However, it is unclear whether they can help prevent allergy and food intolerance in infants without clinical evidence of allergy or food intolerance.
Objectives: To determine the effect of feeding adapted soy formula compared to human milk, cow's milk formula or a hydrolysed protein formula on preventing allergy or food intolerance in infants without clinical evidence of allergy or food intolerance.
Selection criteria: Randomised and quasi-randomised trials that compare the use of an adapted soy formula to human milk, an adapted cow's milk or a hydrolysed protein formula for feeding infants without clinical allergy or food intolerance in the first six months of life. Only trials with > 80% follow up of participants and reported in group of assignment were eligible for inclusion.