TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Despite the enrollment of more than 3000 women in randomised trials, the benefits and risks of neoadjuvant chemotherapy in the treatment of locally advanced cervical cancer remained uncertain.
Objectives: This systematic review and individual patient data (IPD) meta-analysis aimed to assess the effect of neoadjuvant chemotherapy in two comparisons: (1) neoadjuvant chemotherapy followed by radical radiotherapy compared to the same radiotherapy alone; and (2) neoadjuvant chemotherapy followed by surgery compared to radical radiotherapy alone.
Selection criteria: To be included, trials had to be properly randomised and had to include patients with locally advanced cervical cancer who had received neoadjuvant cytotoxic chemotherapy before radiotherapy or surgery or both treatments. Concurrent chemoradiotherapy trials were not included. The comparisons had to be unconfounded by use of additional agents or interventions. Patient enrollment should have started after 1 January 1975 and be completed by September 2000.
Background: Quetiapine is an atypical antipsychotic with, theoretically, a low propensity for movement disorder adverse effects. It is used for the treatment of schizophrenia and other psychoses.
Objectives: To determine the effects of quetiapine for schizophrenia in comparison to placebo, and other antipsychotics.
Selection criteria: All randomised controlled trials where adults with schizophrenia or similar illnesses were assigned to quetiapine, placebo or other neuroleptic drugs and where clinically relevant outcomes were reported.
Background: It has been argued that infants in Neonatal Intensive Care Units are subject both to a highly stressful environment - continuous, high-intensity noise and bright light - and to a lack of the tactile stimulation that they would otherwise experience in the womb or in general mothering care. As massage seems to both decrease stress and provide tactile stimulation, it has been recommended as an intervention to promote growth and development of preterm and low-birth weight infants.
Objectives: To determine whether preterm and/or low birth-weight infants exposed to massage experience improved weight gain and earlier discharge compared to infants receiving standard care; to determine whether massage has any other beneficial or harmful effects on this population.
Selection criteria: Randomised trials in which infants with gestational age at birth <37 weeks or weight at birth <2500g received systematic tactile stimulation by human hands. At least one outcome assessing weight gain, length of stay, behaviour or development must be reported.
Background: Brain oedema is a major cause of early death after stroke. A 10% solution of glycerol is a hyperosmolar agent that is claimed to reduce brain oedema.
Objectives: To determine whether intravenous (I.V.) glycerol treatment in acute stroke, either ischaemic or haemorrhagic, influences death rates and functional outcome in the short or long term, and whether the treatment is safe.
Selection criteria: All completed, randomised and quasi-randomised, controlled, published and unpublished comparisons, evaluating clinical outcome in which I.V. glycerol treatment was initiated within the first days after stroke onset.
Background: Acute anterior shoulder dislocation is the commonest type of shoulder dislocation. Subsequently, the shoulder is less stable and more susceptible to re-dislocation, especially in active young adults.
Objectives: We aimed to compare surgical versus non-surgical treatment for acute anterior dislocation of the shoulder.
Selection criteria: Randomised or quasi-randomised controlled trials comparing surgical with conservative interventions for treating acute anterior shoulder dislocation.
Background: Glutamate is the principal excitatory neurotransmitter in the brain. Injury to the brain can cause an ionic imbalance in cerebral tissue, creating an excitotoxic cascade involving glutamate and other excitatory amino acids, that leads to neuronal death in the tissue surrounding the original injury site. Research has centred around inhibiting this increase in excitatory amino acid during injury either pre- or post-synaptically. Animal studies appeared promising, but as yet, those results have not been repeated in human clinical trials.
Objectives: To assess systematically the efficacy of excitatory amino acid inhibitors on improving patient outcome following traumatic brain injury.
Selection criteria: Trials were included if they were randomised, double-blind, controlled trials where excitatory amino acid inhibitors were administered to patients with traumatic brain injury, within 24 hours of sustaining that injury, and compared to a control group.
Background: A correct prosthetic prescription can be derived from adapting the functional benefits of a prosthesis to the functional needs of the prosthetic user. For adequate matching, the functional abilities of the amputees are of value, as well as the technical and functional aspects of the various prosthetic ankle-foot mechanisms. There seems to be no clear clinical consensus on the precise prescription criteria for the various prosthetic ankle-foot mechanisms related to the functional abilities of amputees.
Objectives: To obtain information about aspects of prosthetic ankle-foot mechanisms and daily functioning of amputees with a prosthesis, for appropriate prosthetic prescription criteria.
Selection criteria: All randomised controlled trials and quasi-randomised controlled trials comparing different prosthetic devices for lower limb amputation in adults. No language restrictions were applied.
Background: Studies in animal models have suggested that naloxone, a specific opiate antagonist, may improve outcomes for newborn infants with perinatal asphyxia.
Objectives: In newborn infants of greater than 34 weeks' gestation with suspected perinatal asphyxia: to assess the effects of naloxone versus placebo or no drug, and of single versus multiple doses of naloxone, on mortality, long term neurological problems, severity of hypoxic-ischaemic encephalopathy, and frequency of neonatal seizures.
Selection criteria: Randomised or quasi-randomised controlled trials comparing naloxone versus placebo, or no drug, or another dose of naloxone, in newborn infants of greater than 34 weeks' gestation with suspected perinatal asphyxia.
Background: Clinical management of the muscle spasms and rigidity of tetanus poses a difficult therapeutic problem to physicians everywhere, especially in resource poor countries. There are wide variations in therapeutic regimens commonly used in clinical practice due to uncertainties about effectiveness of conventional drugs. Diazepam compared to other drugs (eg phenobarbitone and chlorpromazine) may have advantages because of combined anticonvulsant, muscle relaxant, sedative and anxiolytic effects.
Objectives: To compare diazepam to other drugs in treating the muscle spasms and rigidity of tetanus in children and adults.
Selection criteria: Randomized and quasi-randomized controlled trials.
Background: A number of randomised studies suggest hydroxyurea given alongside radiotherapy improves survival in patients with locally advanced cervix cancer. Following publication of five large randomised trials in 1999 and 2000 concomitant chemoradiotherapy has become standard treatment for these patients. In two of the studies hydroxyurea was given to patients in both control and experimental arms. The precise role of this orally administered cytotoxic drug is not known.
Objectives: To assess the effectiveness (survival and toxicity) of concomitant radiation and hydroxyurea compared with radiotherapy alone in treating locally advanced cervix cancer.
Selection criteria: Randomized controlled trials comparing concomitant radiotherapy (+/- surgery) with hydroxyurea versus radiotherapy (+/- surgery) for locally advanced cervix cancer.
Background: Information is routinely given to pregnant women, but information about caesarean birth may be inadequate.
Objectives: To examine the effectiveness of information about caesarean birth.
Selection criteria: Randomised controlled trials, non-randomised clinical trials and controlled before-and-after studies of information given to pregnant women about caesarean birth.
Background: Specialist medical practitioners have conducted clinics in primary care and rural hospital settings for a variety of reasons in many different countries. Such clinics have been regarded as an important policy option for increasing the accessibility and effectiveness of specialist services and their integration with primary care services.
Objectives: To undertake a descriptive overview of studies of specialist outreach clinics and to assess the effectiveness of specialist outreach clinics on access, quality, health outcomes, patient satisfaction, use of services, and costs.
Selection criteria: Randomised trials, controlled before and after studies and interrupted time series analyses of visiting specialist outreach clinics in primary care or rural hospital settings, either providing simple consultations or as part of complex multifaceted interventions. The participants were patients, specialists, and primary care providers. The outcomes included objective measures of access, quality, health outcomes, satisfaction, service use, and cost.
Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) are usually preferred for simple analgesics such as paracetamol for rheumatoid arthritis. It is not clear, however, whether the trade-offs between benefits and harms of NSAIDs are preferable to those of paracetamol (paracetamol is also called acetaminophen).
Objectives: To compare the benefits and harms of paracetamol with NSAIDs in patients with rheumatoid arthritis.
Selection criteria: Randomised double-blind studies comparing paracetamol with an NSAID.
Background: Wound and bone infections are frequently associated with open fractures of the extremities and may add significantly to the resulting morbidity. The administration of antibiotics is routinely used in developed countries as an adjunct to a comprehensive management protocol that also includes irrigation, surgical debridement and stabilisation when indicated, and is thought to reduce the frequency of infections.
Objectives: To quantify the evidence for the effectiveness of antibiotics in the initial treatment of open fractures of the limbs.
Selection criteria: Randomised or quasi-randomised controlled trials involving: participants - people of any age with open fractures of the limbs; intervention - antibiotic administered before or at the time of primary treatment of the open fracture compared with placebo or no antibiotic; outcome measures - early wound infection, chronic drainage, acute or chronic osteomyelitis, delayed unions or non-unions, amputations and deaths.
Background: Artificial and bioartificial liver support systems may 'bridge' patients with acute or acute-on-chronic liver failure to liver transplantation or recovery.
Objectives: To evaluate beneficial and harmful effects of artificial and bioartificial support systems for acute and acute-on-chronic liver failure.
Selection criteria: Randomised clinical trials on artificial or bioartificial support systems for acute or acute on-chronic liver failure were included irrespective of blinding, publication status, or language. Non-randomised studies were included in explorative analyses.
Background: Crohn's disease may be refractory to conventional treatments such as corticosteroids, enteral nutrition and immuno-suppressive agents. A number of patients with the disease may also become steroid-dependent leading to increased risk of developing steroid-related adverse effects. Recent studies suggest that TNF-a blocking agents may be effective in inducing remission in Crohn's disease.
Objectives: To conduct a systematic review to evaluate the effectiveness of TNF-a blocking agents in inducing remission in patients with active Crohn's disease.
Selection criteria: We included only randomised controlled trials in which patients with active Crohn's disease (defined by a validated Crohn's disease activity index) were randomly allocated to receive a TNF-a blocking agent in the treatment arm, or to receive placebo or another treatment in the comparison arm.
Background: Trifluoperazine is an inexpensive accessible 'high potency' antipsychotic drug, widely used to treat schizophrenia or related psychoses.
Objectives: To estimate the effects of trifluoperazine compared with placebo and other drugs.
Selection criteria: All clinical randomised trials involving people with schizophrenia and comparing trifluoperazine with any other treatment.
Background: For persons with rheumatoid arthritis (RA) the physical, personal, familial, social and vocational consequences are extensive. Occupational therapy (OT), with the aim to facilitate task performance and to decrease the consequences of rheumatoid arthritis for daily life activities, is considered to be a cornerstone in the management of rheumatoid arthritis. Till now the efficacy of occupational therapy for patients with rheumatoid arthritis on functional performance and social participation has not been systematically reviewed.
Objectives: To determine whether OT interventions (classified as comprehensive therapy, training of motor function, training of skills, instruction on joint protection and energy conservation, counseling, instruction about assistive devices and provision of splints) for rheumatoid arthritis patients improve outcome on functional ability, social participation and/or health related quality of life.
Selection criteria: Controlled (randomized and non-randomized) and other than controlled studies (OD) addressing OT for RA patients were eligible for inclusion.
Background: Multiple Sclerosis (MS) is a chronic, recurrent and progressive illness with no cure. On the basis of speculative pathophysiology, it has been suggested that Hyperbaric Oxygen Therapy (HBOT) may slow or reverse the progress of the disease.
Objectives: The object of this review was to evaluate the efficacy and safety of HBOT in the treatment of MS.
Selection criteria: All randomised, controlled trials involving a comparison between HBOT and a sham therapy in MS were evaluated.
Background: Although there is a consensus that antidepressants are effective in depression, placebo effects are also thought to be substantial. Side effects of antidepressants may reveal the identity of medication to participants or investigators and thus may bias the results of conventional trials using inert placebos. Using an 'active' placebo which mimics some of the side effects of antidepressants may help to counteract this potential bias.
Objectives: To investigate the efficacy of antidepressants when compared with 'active' placebos.
Selection criteria: Randomised and quasi randomised controlled trials comparing antidepressants with active placebos in people with depression.
Background: Rotaviruses cause viral gastroenteritis and result in more deaths from diarrhoea in children under 5 years of age than any other single agent, particularly in low- and middle-income countries.
Objectives: To assess rotavirus vaccines in relation to preventing rotavirus diarrhoea, death, and adverse events.
Selection criteria: Randomized controlled trials comparing rotavirus vaccines to placebo, no intervention, or other rotavirus vaccines in children and adults.
Background: Timed voiding is a fixed time interval toileting assistance program that has been promoted for the management of people with urinary incontinence who cannot participate in independent toileting. For this reason, it is commonly assumed to represent current practice in residential aged care settings.
Objectives: To assess the effects of timed voiding for the management of urinary incontinence in adults who cannot participate in independent toileting.
Selection criteria: We selected all randomised and quasi-randomised trials that addressed timed voiding in an adult population and that had an alteration in continence status as a primary outcome. We included those trials that had assessed timed voiding delivered either alone or in combination with another intervention and compared it with either usual care, or no timed voiding, or another intervention.
Background: Topical fluoride therapy (TFT) in the form of toothpastes, mouthrinses, varnishes and gels are effective caries preventive measures. However, there is uncertainty about the relative value of these interventions when used together.
Objectives: To compare the effectiveness of two TFT modalities combined with one of them alone (mainly toothpaste) when used for the prevention of dental caries in children.
Selection criteria: Randomized or quasi-randomized controlled trials with blind outcome assessment, comparing fluoride varnish, gel, mouthrinse, or toothpaste in combination with each other in children up to 16 years during at least 1 year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces (D(M)FS).
Background: Topical fluorides in the form of toothpaste, mouthrinse, varnish and gel are effective caries preventive measures. However, there is uncertainty about the relative value of these interventions.
Objectives: To compare the effectiveness of one form of topical fluoride intervention with another when used for the prevention of dental caries in children.
Selection criteria: Randomized or quasi-randomized controlled trials with blind outcome assessment, comparing fluoride varnish, gel, mouthrinse, or toothpaste with each other in children up to 16 years during at least 1 year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces (D(M)FS).
Background: Achalasia is a disease that impairs oesophageal motility. Though nitrates have been used to treat achalasia for a long time, the effectiveness of nitrates for achalasia is still controversial.
Objectives: To quantify short-term and long-term effects of nitrate therapy in patients with achalasia.
Selection criteria: All randomised controlled trials involving achalasic patients given any type of nitrates were included.
Background: Symptomatic benign prostatic obstruction is a common problem for older men. The gold standard treatment, transurethral resection of the prostate (TURP), significantly improves urinary symptoms and urinary flow. However, TURP has up to a 20% morbidity. Currently, there are a number of minimally invasive procedures that may be safe, effective alternatives to TURP. One promising surgical technique is laser prostatectomy.
Objectives: To assess the therapeutic efficacy and safety of laser prostatectomy techniques for treating men with symptomatic benign prostatic obstruction.
Selection criteria: All randomized controlled trials evaluating laser prostatectomy treatment for men with symptomatic BPH. Trials were eligible if they (1) were randomized comparisons of a laser technique with TURP, (2) included at least 10 men with BPO in each treatment arm, (3) provided at least 6-months follow-up, and (4) included clinical outcomes such as urologic symptom scales or urodynamic measurements.
Background: Public concerns regarding the safety of transfused blood have prompted re-consideration of the use of allogeneic (from an unrelated donor) red blood cell (RBC) transfusion, and of a range of techniques designed to minimise transfusion requirements.
Objectives: To examine the evidence for the efficacy of desmopressin acetate (1-deamino-8-D-arginine-vasopressin; DDAVP), in reducing perioperative blood loss and the need for red cell transfusion in patients who do not have congenital bleeding disorders.
Selection criteria: Controlled parallel group trials in which adult patients, scheduled for non-urgent surgery, were randomised to DDAVP, or to a control group, who did not receive the intervention.
Background: Ketotifen is an antihistamine which may be used to treat asthma. Since administering inhaled therapy to younger children can be difficult, an oral agent such as ketotifen offers potential advantages.
Objectives: The objective of this review is to determine, whether ketotifen alone or in combination with other co-interventions results in better control of asthma in children with asthma and/or wheezing and examine its safety profile.
Selection criteria: Clinical studies had to be randomised-controlled and double-blinded, comparing oral ketotifen with placebo in children with asthma and/or wheeze for at least eight weeks at a dose not less than one mg daily.
Background: Urinary incontinence is a common and distressing problem. Bladder training aims to increase the interval between voids and is widely used for the treatment of urinary incontinence.
Objectives: To assess the effects of bladder training for the treatment of urinary incontinence.
Selection criteria: Randomised or quasi-randomised trials of bladder training for the treatment of any type of urinary incontinence.
Background: In normal menstrual cycles, gonadotrophin releasing hormone (GnRH) secretion is pulsatile, with intervals of 60-120 minutes in the follicular phase. Treatment with pulsatile GnRH infusion by the intravenous or subcutaneous route using a portable pump has been used successfully in patients with hypogonadotrophic hypogonadism. Assuming that the results would be similar in women with polycystic ovary syndrome (PCOS), pulsatile GnRH has been used to induce ovulation in these women. Although ovulation and pregnancy have been achieved, the effectiveness of pulsatile GnRH in women with PCOS has not been clearly demonstrated.
Objectives: To assess the effectiveness of pulsatile GnRH administration in women with polycystic ovary syndrome (PCOS), in terms of ongoing pregnancy, ovulation, clinical pregnancy, ovarian hyperstimulation syndrome (OHSS), multiple pregnancy, miscarriage, and multifollicular growth.
Selection criteria: All relevant published randomised clinical trials were selected for inclusion if treatment consisted of pulsatile GnRH administration versus another treatment for ovulation induction in subfertile women with PCOS.
Background: Homeopathy involves the use, in dilution, of substances which cause symptoms in their undiluted form. It is one of the most widespread forms of complementary medicines and is also used to treat asthma.
Objectives: The objective of this review was to assess the effects of homeopathy in people with chronic stable asthma.
Selection criteria: Randomised trials of homeopathy for the treatment of stable chronic asthma, with observation periods of at least one week were included.
Background: The routine prophylactic administration of an uterotonic agent is an integral part of active management of the third stage of labour, helping to prevent postpartum haemorrhage (PPH). The two most widely used uterotonic agents are: ergometrine-oxytocin (Syntometrine) (a combination of oxytocin 5 international units (iu) and ergometrine 0.5 mg) and oxytocin (Syntocinon).
Objectives: To compare the effects of ergometrine-oxytocin with oxytocin in reducing the risk of PPH (blood loss of at least 500 ml) and other maternal and neonatal outcomes.
Selection criteria: Randomised trials comparing ergometrine-oxytocin use with oxytocin use in women having the third stage of labour managed actively.
Background: Acupuncture has traditionally been used to treat asthma in China and is used increasingly for this purpose internationally.
Objectives: The objective of this review was to assess the effects of acupuncture for the treatment of asthma or asthma-like symptoms.
Selection criteria: Randomised and possibly randomised trials using needle acupuncture or other forms of stimulation of acupuncture. Any form of control treatment was considered (no treatment in addition to conventional asthma treatment, sham or placebo interventions, active comparator interventions). Studies were included provided outcome was assessed at one week or more.