TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Surgical investigations and interventions account for large health care utilisation and costs, but the scientific evidence for most procedures is still limited.
Objectives: Degenerative conditions affecting the lumbar spine are variously described as lumbar spondylosis or degenerative disc disease (which we regarded as one entity) and may be associated with back pain and associated leg symptoms, instability, spinal stenosis and/or degenerative spondylolisthesis. The objective of this review was to assess current scientific evidence on the effectiveness of surgical interventions for degenerative lumbar spondylosis.
Selection criteria: Randomised (RCTs) or quasi-randomised trials of surgical treatment of lumbar spondylosis.
Background: Chloroquine (CQ), amodiaquine (AQ), and sulfadoxine-pyrimethamine (SP) are inexpensive drugs, but treatment failure is a problem. Combination therapy may reduce treatment failure. CQ or AQ plus SP are affordable options of combination treatment, but there is debate about their effectiveness.
Objectives: To assess the combination of CQ or AQ plus SP compared with SP alone for first-line treatment of uncomplicated falciparum malaria.
Selection criteria: Randomized controlled trials in adults or children with uncomplicated Plasmodium falciparum malaria were eligible for inclusion. The main outcomes of interest were total and clinical failure at day 28 follow up and serious adverse events.
Background: The pathophysiology of so called 'cough variant asthma' has not received a great deal of research interest and opinion lies divided as to whether it is really asthma or not. The proponents of cough variant asthma suggest a therapeutic trial of medications usually used to treat asthma
Objectives: To determine the effectiveness of inhaled ss2 agonists in non-specific chronic cough in children over the age of 2 years.
Selection criteria: All randomised (randomised and quasi-randomised) controlled clinical trials in which inhaled ss2 agonists were given for chronic cough in children over 2 years of age were included. Two reviewers independently assessed articles for inclusion and methodological quality.
Background: Traditional treatment methods for haemorrhoids fall into two broad groups: less invasive techniques including rubber band ligation (RBL), which tend to produce minimal pain, and the more radical techniques like excisional haemorrhoidectomy (EH), which are inherently more painful. For decades, innovations in the field of haemorrhoidal treatment have centred on modifying the traditional methods to achieve a minimally invasive, less painful procedure and yet with a more sustainable result. The availability of newer techniques has reopened debate on the roles of traditional treatment options for haemorrhoids.
Objectives: To review the efficacy and safety of the two most popular conventional methods of haemorrhoidal treatment, rubber band ligation and excisional haemorrhoidectomy.
Selection criteria: Randomised controlled trials comparing rubber band ligation with excisional haemorrhoidectomy for symptomatic haemorrhoids in adult human patients were included.
Background: It has been postulated that monoamine oxidase B (MAO-B) inhibitors alter disease progression in Parkinson's disease (PD). Clinical trials have produced conflicting results.
Objectives: To assess the evidence from randomized controlled trials for the effectiveness and safety of long-term use of MAO-B inhibitors in early PD.
Selection criteria: We sought to include all unconfounded randomized controlled trials that compared a MAO-B inhibitor with control, in the presence or absence of levodopa or dopamine agonists, in patients with early PD and where treatment and follow up lasted at least one year.
Background: Vitamin B12 deficiency is common and rises with age. Most people with vitamin B12 deficiency are treated in primary care with intramuscular vitamin B12 which is a considerable source of work for health care professionals. Several case control and case series studies have reported equal efficacy of oral administration of vitamin B12 but it is rarely prescribed in this form, other than in Sweden and Canada. Doctors may not be prescribing oral formulations because they are unaware of this option or have concerns regarding effectiveness.
Objectives: To assess the effectiveness of oral vitamin B12 versus intramuscular vitamin B12 for vitamin B12 deficiency.
Selection criteria: Randomised controlled trials (RCTs) examining the use of oral or intramuscular vitamin B12 to treat vitamin B12 deficiency.
Background: Late onset neonatal sepsis (systemic infection after 48 hours of age) continues to be a significant cause of morbidity and mortality. Early treatment with antibiotics is essential as infants can deteriorate rapidly. It is not clear which antibiotic regimen is most suitable for initial treatment of suspected late onset sepsis.
Objectives: To compare the effectiveness and adverse effects of different antibiotic regimens for treatment of suspected late onset sepsis in newborn infants.
Selection criteria: Randomised and quasi randomised controlled trials comparing different initial antibiotic regimens in neonates with suspected late onset sepsis were evaluated.
Background: Multiple lumen umbilical venous catheters (ML-UVCs) instead of single lumen UVCs (SL-UVCs) may decrease the need for additional venous lines. Although it seems self-evident that ML-UVCs would reduce the need of additional venous lines, the rates of associated complications might be different.
Objectives: To compare the effectiveness and the safety of ML-UVCs versus SL-UVCs in terms of need of additional vascular access, rates of complications, morbidity and mortality in newborn infants.
Selection criteria: Randomized and quasi-randomized controlled clinical trials comparing safety and efficacy of multiple versus single lumen umbilical venous catheter in neonates (both term and preterm) who were in need of umbilical venous catheter insertion for vascular access in first four weeks of life.
Background: Haemorrhoids (piles) are swollen veins at or near the anus, normally asymptomatic. They do not constitute a disease, unless they become symptomatic. Pregnancy and the puerperium predispose to symptomatic haemorrhoids, being the most common ano-rectal disease at these stages. Symptoms are usually mild and transient and include intermittent bleeding from the anus and pain. Depending on the degree of pain, quality of life could be affected, varying from mild discomfort to real difficulty in dealing with the activities of everyday life. Treatment during pregnancy is mainly directed to the relief of symptoms, especially pain control. The so-called conservative management includes dietary modifications, stimulants or depressants of the bowel transit, local treatment, and phlebotonics (drugs that cause decreased capillary fragility, improving the microcirculation in venous insufficiency). For many women, symptoms will resolve spontaneously soon after birth, and so any corrective treatment is usually deferred to some time after birth. Thus, the objective of this review is to evaluate the efficacy of conservative management of piles during pregnancy and the puerperium.
Objectives: To determine the possible benefits, risks and side-effects of the conservative management of symptomatic haemorrhoids during pregnancy and the puerperium.
Selection criteria: Randomised-controlled trials comparing any of the conservative treatments for symptomatic haemorrhoids during pregnancy and the puerperium (such as dietary modifications, stimulant/depressant of the bowel transit, local treatments, drugs that improve the microcirculation in venous insufficiency) with a placebo or no treatment.
Background: Immunization rates for children and adults are rising, but coverage levels have not reached optimal goals. As a result of low immunization rates, vaccine-preventable diseases still occur. In an era of increasing complexity of immunization schedules, rising expectations about the performance of primary care and large demands on primary care physicians, it is important to understand and promote interventions that work in primary care settings to increase immunization coverage. A common theme across immunization programs in all nations involves the challenge of determining the denominator of eligible recipients (e.g. all children who should receive the measles vaccine) and identifying the best strategy to ensure high vaccination rates. Strategies have focused on patient-oriented interventions (e.g., patient reminders), provider interventions and system interventions. One intervention strategy involves patient reminder and recall systems.
Objectives: To assess the effectiveness of patient reminder and recall systems in improving immunization rates and compare the effects of various types of reminders in different settings or patient populations.
Background: HIV-infected people and AIDS patients often seek complementary therapies including herbal medicines due to reasons such as unsatisfactory effects, high cost, non-availability, or adverse effects of conventional medicines.
Objectives: To assess beneficial effects and risks of herbal medicines in patients with HIV infection and AIDS.
Selection criteria: Randomized clinical trials on herbal medicines compared with no intervention, placebo, or antiretroviral drugs in patients with HIV infection, HIV-related disease, or AIDS. The outcomes included mortality, HIV disease progression, new AIDS-defining event, CD4 cell counts, viral load, psychological status, quality of life, and adverse effects.
Background: Crohn's disease in childhood is a chronic relapsing condition. Fifteen to forty per cent of children with Crohn's disease have growth retardation (Griffiths 1993a). Some treatment modalities including corticosteroids have been implicated in growth failure but it is thought mainly to be secondary to uncontrolled disease activity (Motil 1993; Markowitz 1993). Growth is fundamental to the practice of pediatrics, so by taking growth as the primary outcome measure we address issues important to both patients, their families and pediatricians.
Objectives: To evaluate the effectiveness of the different modalities available for the treatment of childhood Crohn's disease with regard to the reversal of growth failure and the promotion of normal growth.
Selection criteria: Randomized controlled trials pertaining to children less than 18 years of age with Crohn's disease were selected. Those with growth as an outcome measure were included in the review.
Background: Acute respiratory infections, mostly in the form of pneumonia, are the leading causes of death in children under five years of age in developing countries. Some clinical trials have demonstrated that vitamin A supplementation reduces the severity of respiratory infection and mortality in children with measles.
Objectives: To determine whether adjunctive vitamin A is effective in infants and children diagnosed with non-measles pneumonia.
Selection criteria: Only parallel-arm, randomised and quasi-randomised controlled trials in which children (younger than 15 years old) with non-measles pneumonia were treated with adjunctive vitamin A were included.
Background: Breast stimulation has been suggested as a means of inducing labour. It is a non-medical intervention allowing women greater control over the induction process. This is one of a series of reviews of methods of cervical ripening and labour induction using a standardised methodology.
Objectives: To determine the effectiveness of breast stimulation for third trimester cervical ripening or induction of labour in comparison with placebo/no intervention or other methods of induction of labour.
Selection criteria: Clinical trials of breast stimulation for third trimester cervical ripening or labour induction.
Background: When the kidney fails the blood-borne metabolites of protein breakdown and water cannot be excreted. The principle of haemodialysis is that such substances can be removed when blood is passed over a semipermeable membrane. Natural membrane materials include cellulose or modified cellulose, more recently various synthetic membranes have been developed. Synthetic membranes are regarded as being more "biocompatible" in that they incite less of an immune response than cellulose-based membranes.
Objectives: To assess the effects of different haemodialysis membrane material in patients with end-stage renal disease (ESRD).
Selection criteria: All randomised controlled trials (RCTs) or quasi-RCTs comparing different haemodialysis membrane material in patients with ESRD.
Background: Subcapital fractures of the fifth metacarpal bone, meaning fractures just below the knuckle of the little finger, account for approximately 20% of all hand fractures. Currently, there is no consensus concerning the optimal management of these fractures. Traditionally, treatment consists of closed reduction and external splinting in a neutral position using plaster of Paris (POP), involving the metacarpal joint, the proximal interphalangeal joint and the carpo-metacarpal joint. An alternative treatment strategy is functional treatment using taping or bracing that does not restrict movement.
Objectives: To compare functional treatment with immobilization, and to compare different periods and types of immobilization, for the treatment of closed fifth metacarpal neck fractures in adults.
Selection criteria: All randomized and quasi-randomized controlled trials which compare functional treatment with immobilization or different types of immobilization for closed fifth metacarpal neck fractures.
Background: Loop diuretics, when given as intermittent bolus injections in acutely decompensated heart failure, may cause fluctuations in intravascular volume, increased toxicity and development of tolerance. Continuous infusion has been proposed to avoid these complications and result in greater diuresis, hopefully leading to faster symptom resolution, decrease in morbidity and possibly, mortality.
Objectives: To compare the effects and adverse effects of continuous intravenous infusion of loop diuretics with those of bolus intravenous administration among patients with congestive heart failure Class III-IV.
Selection criteria: Randomized controlled trials comparing the efficacy of continuous intravenous infusion versus bolus intravenous administration of loop diuretics in congestive heart failure were included
Background: Colorectal resections are common surgical procedures all over the world. Laparoscopic colorectal surgery is technically feasible in a considerable amount of patients under elective conditions. Several short-term benefits of the laparoscopic approach to colorectal resection (less pain, less morbidity, improved reconvalescence and better quality of life) have been proposed.
Objectives: This review compares laparoscopic and conventional colorectal resection with regards to possible benefits of the laparoscopic method in the short-term postoperative period (up to 3 months post surgery).
Selection criteria: All randomised-controlled trial were included regardless of the language of publication. No- or pseudorandomised trials as well as studies that followed patient's preferences towards one of the two interventions were excluded, but listed separately. RCT presented as only an abstract were excluded.
Background: There is a hypothesis that high dose chemotherapy with autologous bone marrow or peripheral stem cell transplantation (autograft) may improve survival for women with metastatic breast cancer.
Objectives: To compare the effectiveness of high dose chemotherapy and autologous bone marrow or stem cell transplantation with conventional chemotherapy for women with metastatic breast cancer.
Selection criteria: Randomised controlled trials comparing the effectiveness of high dose chemotherapy and autograft with conventional chemotherapy for women with metastatic breast cancer. Studies included one or more of the following outcomes: treatment related mortality, overall or progression-free survival at 1, 2, 3, 5 or 7 years, morbidity, quality of life measures, time to tumour progression, overall survival time.
Background: Miscarriage is the spontaneous loss of a pregnancy before the fetus is viable. Uterine muscle relaxant drugs have been used for women at risk of miscarriage in the belief they relax uterine muscle, and hence reduce the risk of miscarriage.
Objectives: To assess the effects for the woman and her baby of uterine muscle relaxant drugs when used for threatened miscarriage.
Selection criteria: Randomised trials were included, and quasi-randomised trials were excluded. The participants were women with a pregnancy of less than 20 weeks' gestation having a threatened miscarriage. The interventions were any uterine muscle relaxing drugs (including tocolytic and antispasmodic agents) compared with either placebo or no drug. Primary outcomes for the review were miscarriage: defined as spontaneous pregnancy loss before fetal viability, baby death (stillbirth or neonatal death) and maternal death.
Background: The National Cancer Institute (USA) alert in February 1999 stated that concomitant chemoradiotherapy should be considered for all patients with cervical cancer, based on evidence from five randomised controlled trials (RCTs).
Objectives: To review all known RCTs comparing concomitant chemotherapy and radiation therapy with radiotherapy for locally advanced cervical cancer.
Selection criteria: This review includes RCTs in cervical cancer comparing concomitant chemoradiation with radiotherapy in the experimental arm. Trials allowing further adjuvant chemotherapy or hydroxyurea were included. Trials using radiosensitisers or radioprotectors in the experimental arm were excluded.
Background: Non-valvular atrial fibrillation (AF) is associated with an increased risk of stroke mediated by embolism of stasis-precipitated thrombi from the left atrial appendage.
Objectives: The objective is to characterize the efficacy and safety of oral anticoagulants (OACs) for the primary prevention of stroke in patients with chronic AF.
Selection criteria: All randomized controlled trials comparing OACs with control in patients with chronic non-valvular atrial fibrillation and no history of transient ischemic attack (TIA) or stroke.
Background: Adrenergic drugs have been used for the treatment of urinary incontinence. However, they have generally been considered to be ineffective or to have side effects which may limit their clinical use.
Objectives: To determine the effectiveness of adrenergic agonists in the treatment of urinary incontinence in adults.
Selection criteria: Randomised or quasi-randomised controlled trials in adults with urinary incontinence which included an adrenergic agonist drug in at least one arm of the trial.
Background: Antipsychotic drugs are usually given orally but compliance with medication given by this route may be difficult to quantify. The development of depot injections in the 1960s gave rise to extensive use of depots as a means of long-term maintenance treatment. Perphenazine decanoate and enanthate are depot antipsychotics that belong to the phenothiazine family and have a piperazine ethanol side chain.
Objectives: To assess the effects of depot perphenazine decanoate and enanthate versus placebo, oral antipsychotics and other depot antipsychotic preparations for people with schizophrenia in terms of clinical, social and economic outcomes.
Selection criteria: We compared randomised clinical trials focusing on people with schizophrenia where depot perphenazine decanoate and enanthate, oral antipsychotics or other depot preparations.
Background: Sertindole is an atypical antipsychotic, which is thought to give a lower incidence of extrapyramidal side effects at clinically effective doses than typical antipsychotic drugs. In December 1998, Lundbeck Ltd., the manufacturers of sertindole, voluntarily suspended the availability of the drug due to concerns about cardiac arrhythmia and sudden cardiac death associated with its use. However, based on the advice of an appointed expert group, the Committee for Proprietary Medicinal Products (CPMP) lifted the suspension of sertindole in October 2001, a decision that was ratified by the European Commission on the 26th of June 2002. Lundbeck have committed to the CPMP to carry out two post-marketing surveillance (PMS) studies (which were initiated in July 2002) to provide additional epidemiological data under conditions of normal drug usage. Initial marketing of the product will be restricted and Lundbeck is currently in discussions with the US health authorities (FDA) to investigate whether, and if so when, it would be possible to launch Serdolect in the US market.
Objectives: To determine the effects of sertindole compared with placebo, typical and other atypical antipsychotic drugs for schizophrenia and related psychoses.
Selection criteria: All randomised controlled trials that compared sertindole to placebo or other antipsychotic (atypical or typical) drug treatments for patients with schizophrenia or related psychosis .
Background: Appendicitis is the most common cause of acute abdominal pain requiring surgical intervention. The cause of appendicitis is unclear and the mechanism of pathogenesis continues to be debated. Despite improved asepsis and surgical techniques, postoperative complications, such as wound infection and intraabdominal abscess, still account for a significant morbidity. Several studies implicate that postoperative infections are reduced by administration of antimicrobial regimes.
Objectives: This review evaluated the use of antibiotics compared to placebo or no treatment in patients undergoing appendectomy. Will these patients benefit from antimicrobial prophylaxis? The outcomes were described according to the nature of the appendix, as either simple appendicitis (including the non-infectious stage) and complicated appendicitis. The efficacy of different antibiotic regimens were not evaluated.
Selection criteria: We evaluated Randomised Controlled Trials (RCTs) and Controlled Clinical Trials (CCTs) in which any antibiotic regime were compared to placebo in patients suspected of having appendicitis, and undergoing appendectomy. Both studies on children and adults were reviewed. The outcome measures of the studies were: Wound infection, intra abdominal abscess, length of stay in hospital, and mortality.
Background: Wheeze in infancy and early childhood is common and appears to be increasing though the magnitude of any increase is unclear. Most wheezing episodes in infancy are precipitated by respiratory viral infections. Treatment of very young children with wheeze remains controversial. Anti-cholinergics are often prescribed but practice varies widely and the efficacy of this form of therapy remains the subject for debate.
Objectives: Wheeze in infancy and early childhood is common and appears to be increasing. Most wheezing episodes in infancy are a result of viral infection. Bronchodilator medications such as beta2-agonists and anti-cholinergic agents are often used to relieve symptoms, but patterns of use vary. The objective of this review was to assess the effects of anti-cholinergic therapy in the treatment of wheezing infants. This is a second update of this review.
Selection criteria: Randomised trials that compared anti-cholinergic therapy with placebo or beta2-agonists in wheezing children under two years of age. Children with acute bronchiolitis and chronic lung disease were excluded.