TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Posterior capsule opacification (PCO) remains the most common long-term complication after cataract surgery. It can be treated by Nd:YAG laser capsulotomy, however this may lead to other complications and laser treatment is not available in large parts of the developing world. Therefore, many studies try to find factors influencing the development of PCO.
Objectives: To summarise the effects of different interventions to inhibit PCO. These include modifications of surgical technique and intraocular lens (IOL) design, implantation of additional devices and pharmacological interventions.
Selection criteria: We included only prospective, randomised and controlled trials with a follow-up time of at least 12 months. Interventions included modifications in surgical technique explicitly to inhibit PCO, modifications in IOL design (material and geometry), implantation of additional devices and pharmacological therapy compared to each other, placebo or standard treatment.
Background: Aggression is a major public health issue and is integral to several mental health disorders. Antiepileptic drugs may reduce aggression by acting on the central nervous system to reduce neuronal hyper-excitability associated with aggression.
Objectives: To evaluate the efficacy of antiepileptic drugs in reducing aggression and associated impulsivity.
Selection criteria: Prospective, placebo-controlled trials of antiepileptic drugs taken regularly by individuals with recurrent aggression to reduce the frequency or intensity of aggressive outbursts.
Background: Golimumab is a humanized inhibitor of Tumor necrosis factor-alpha, recently approved by the Food and Drug Administration (FDA) for the treatment of Rheumatoid arthritis (RA).
Objectives: The objective of this systematic review was to compare the efficacy and safety of golimumab (alone or in combination with DMARDs or biologics) to placebo (alone or in combination with DMARDs or biologics) in randomized or quasi-randomized clinical trials in adults with RA.
Selection criteria: Studies were included if they used golimumab in adults with RA, were randomized or quasi-randomized and provided clinical outcomes.
Background: Patients with symptomatic cholecystolithiasis are treated by three different techniques of cholecystectomy: open, small-incision, or laparoscopic. There is no overview on Cochrane systematic reviews on these three interventions.
Objectives: To summarise Cochrane reviews that assess the effects of different techniques of cholecystectomy for patients with symptomatic cholecystolithiasis.
Background: After a 1999 National Cancer Institute (NCI) clinical alert was issued, chemoradiotherapy has become widely used in treating women with cervical cancer. Two subsequent systematic reviews found that interpretation of the benefits was complicated and some important clinical questions were unanswered.
Objectives: We initiated a meta-analysis seeking updated individual patient data (IPD) from all randomised controlled trials (RCTs) to assess the effect of chemoradiotherapy on all outcomes. We pre-specified analyses to investigate whether the effect of chemoradiotherapy differed by trial or patient characteristics.
Selection criteria: Both published and unpublished trials were eligible for inclusion provided the patients had been randomised between radiotherapy (with or without surgery) versus concomitant chemoradiotherapy (with or without surgery); that the method of randomisation precluded prior knowledge of the treatment to be assigned; and that the trial had completed patient recruitment before the date of the final analyses.
Background: Adenoidectomy, surgical removal of the adenoids, is a common ENT operation worldwide in children with recurrent or chronic nasal symptoms. A systematic review on the effectiveness of adenoidectomy in this specific group has not previously been performed.
Objectives: To assess the effectiveness of adenoidectomy versus non-surgical management in children with recurrent or chronic nasal symptoms.
Selection criteria: Randomised controlled trials comparing adenoidectomy, with or without tympanostomy tubes, versus non-surgical management or tympanostomy tubes alone in children with recurrent or chronic nasal symptoms. The primary outcome studied was the number of episodes, days per episode and per year with nasal symptoms and the proportion of children with recurrent episodes of nasal symptoms. Secondary outcomes were mean number of episodes, mean number of days per episode and per year, and proportion of children with nasal obstruction alone.
Background: Vitamin D is produced in the skin after sun-light exposure and can also be obtained through food. Vitamin D deficiency has recently been linked with a range of diseases including chronic pain. Observational and circumstantial evidence suggests that there may be a role for vitamin D deficiency in the aetiology of chronic pain conditions.
Objectives: To assess the efficacy and adverse events of vitamin D supplementation in chronic painful conditions.
Selection criteria: Studies were included if they were randomised double blind trials of vitamin D supplementation compared with placebo or with active comparators for the treatment of chronic pain conditions in adults.
Background: An increase in serious adverse events with both regular formoterol and regular salmeterol in chronic asthma has been demonstrated in comparison with placebo in previous Cochrane reviews. This increase was significant in trials that did not randomise participants to an inhaled corticosteroid, but less certain in the smaller numbers of participants in trials that included an inhaled corticosteroid in the randomised treatment regimen.
Objectives: We set out to compare the risks of mortality and non-fatal serious adverse events in trials which have randomised patients with chronic asthma to regular formoterol versus regular salmeterol, when each are used with an inhaled corticosteroid as part of the randomised treatment.
Selection criteria: Controlled clinical trials with a parallel design, recruiting patients of any age and severity of asthma were included if they randomised patients to treatment with regular formoterol versus regular salmeterol (each with a randomised inhaled corticosteroid), and were of at least 12 weeks duration.
Background: For many years, topical use of fluorides has gained greater popularity than systemic use of fluorides. A possible adverse effect associated with the use of topical fluoride is the development of dental fluorosis due to the ingestion of excessive fluoride by young children with developing teeth.
Objectives: To describe the relationship between the use of topical fluorides in young children and the risk of developing dental fluorosis.
Selection criteria: Randomised controlled trials (RCTs), quasi-RCTs, cohort studies, case-control studies and cross-sectional surveys, in which fluoride toothpastes, mouthrinses, gels, foams, paint-on solutions, and varnishes were compared to an alternative fluoride treatment, placebo or no intervention group. Children under the age of 6 years at the time topical fluorides were used.
Background: Endometrial carcinoma is the most common gynaecological cancer in western Europe and North America. Lymph node metastases can be found in approximately 10% of women who clinically have cancer confined to the womb prior to surgery and removal of all pelvic and para-aortic lymph nodes (lymphadenectomy) is widely advocated. Pelvic and para-aortic lymphadenectomy is part of the FIGO staging system for endometrial cancer. This recommendation is based on non-randomised controlled trials (RCTs) data that suggested improvement in survival following pelvic and para-aortic lymphadenectomy. However, treatment of pelvic lymph nodes may not confer a direct therapeutic benefit, other than allocating women to poorer prognosis groups. Furthermore, a systematic review and meta-analysis of RCTs of routine adjuvant radiotherapy to treat possible lymph node metastases in women with early-stage endometrial cancer, did not find a survival advantage. Surgical removal of pelvic and para-aortic lymph nodes has serious potential short and long-term sequelae and most women will not have positive lymph nodes. It is therefore important to establish the clinical value of a treatment with known morbidity.
Objectives: To evaluate the effectiveness and safety of lymphadenectomy for the management of endometrial cancer.
Selection criteria: RCTs and quasi-RCTs that compared lymphadenectomy with no lymphadenectomy, in adult women diagnosed with endometrial cancer.
Background: Abnormal blood flow patterns in fetal circulation detected by Doppler ultrasound may indicate poor fetal prognosis. It is also possible false positive Doppler ultrasound findings could encourage inappropriate early delivery.
Objectives: The objective of this review was to assess the effects of Doppler ultrasound used to assess fetal well-being in high-risk pregnancies on obstetric care and fetal outcomes.
Selection criteria: Randomised and quasi-randomised controlled trials of Doppler ultrasound for the investigation of umbilical and fetal vessels waveforms in high-risk pregnancies compared to no Doppler ultrasound.
Background: Infection with human immunodeficency virus (HIV) and acquired immunodeficency syndrome (AIDS) is a pandemic that has affected millions of people globally. Although major research and clinical initiatives are addressing prevention and cure strategies, issues of quality of life for survivors have received less attention. Massage therapy is proposed to have a positive effect on quality of life and may also have a positive effect on immune function through stress mediation.
Objectives: The objective of this systematic review was to examine the safety and effectiveness of massage therapy on quality of life, pain and immune system parameters in people living with HIV/AIDS.
Selection criteria: Studies were identified by two reviewers based on trial design (RCTs) and participants (ie, people of any age with HIV/AIDS, at any stage of the disease) who had undergone an intervention that included massage therapy for the identified aims of improving quality of life and activity and participation levels, improving immune function, reducing pain and improving other physiological or psychological impairments.
Background: The single most important risk factor for postpartum maternal infection is cesarean section. Routine prophylaxis with antibiotics may reduce this risk and should be assessed in terms of benefits and harms.
Objectives: To assess the effects of prophylactic antibiotics compared with no prophylactic antibiotics on infectious complications in women undergoing cesarean section.
Selection criteria: Randomized controlled trials (RCTs) and quasi-RCTs comparing the effects of prophylactic antibiotics versus no treatment in women undergoing cesarean section.
Background: Nonalcoholic fatty liver disease (NAFLD) is increasingly recognised as a condition associated with overweight or obesity that may progress to end-stage liver disease. NAFLD histology resembles alcohol-induced liver injury, but occurs in patients with no history of alcohol abuse. NAFLD has a broad spectrum of clinical and histological manifestations, ranging from simple fatty liver to hepatic steatosis with inflammation, advanced fibrosis, and cirrhosis. The inflammatory stage is known as non-alcoholic steatohepatitis (NASH). Recent reports indicate that weight loss induced by bariatric procedures could be beneficial for NASH treatment.
Objectives: To assess the benefits and harms of bariatric surgery for NASH in obese patients.
Selection criteria: All randomised clinical trials evaluating any bariatric procedure versus no intervention, placebo (sham procedure), or other interventions in patients with NASH regardless of publication status, number of patients randomised, language, or blinding. Quasi-randomised clinical studies were to be considered for the review if no randomised clinical trials were identified. If included, their bias towards positive findings was to be considered.
Background: One person in every four will suffer from a diagnosable mental health condition during their life course. Such conditions can have a devastating impact on the lives of the individual, their family and society. Increasingly partnership models of mental health care have been advocated and enshrined in international healthcare policy. Shared decision making is one such partnership approach. Shared decision making is a form of patient-provider communication where both parties are acknowledged to bring expertise to the process and work in partnership to make a decision. This is advocated on the basis that patients have a right to self-determination and also in the expectation that it will increase treatment adherence.
Objectives: To assess the effects of provider-, consumer- or carer-directed shared decision making interventions for people of all ages with mental health conditions, on a range of outcomes including: patient satisfaction, clinical outcomes, and health service outcomes.
Selection criteria: Randomised controlled trials (RCTs), quasi-randomised controlled trials (q-RCTs), controlled before-and-after studies (CBAs); and interrupted time series (ITS) studies of interventions to increase shared decision making in people with mental health conditions (by DSM or ICD-10 criteria).
Background: Miscarriage occurs in 10% to 15% of pregnancies. The traditional treatment, after miscarriage, has been to perform surgery to remove any remaining pregnancy tissues in the uterus. However, it has been suggested that drug-based medical treatments, or expectant care (no treatment), may also be effective, safe and acceptable.
Objectives: To assess the effectiveness, safety and acceptability of any medical treatment for early incomplete miscarriage (before 24 weeks).
Selection criteria: Randomised controlled trials comparing medical treatment with expectant care or surgery. Quasi-randomised trials were excluded.
Background: Drug users (including both injection drug users and crack cocaine users), are at high levels of risk for contracting HIV. Therefore it is important to reduce the injection and/or sexual risk behaviours of these groups both for the benefit of themselves and for society as a whole.
Objectives: To assess the efficacy of multi-session psychosocial interventions in comparison with standard education and minimal intervention controls for the reduction of injection and sexual risk behaviour.
Selection criteria: The inclusion criteria consisted of randomised and quazi-randomised trials assessing the efficacy of psychosocial interventions in the reduction of injection and sexual risk behaviour for people who misused opiates, cocaine, or a combination of these drugs.
Background: The burden of cardiovascular disease world-wide is one of great concern to patients and health care agencies alike. Traditionally centre-based cardiac rehabilitation (CR) programmes are offered to individuals after cardiac events to aid recovery and prevent further cardiac illness. Home-based cardiac rehabilitation programmes have been introduced in an attempt to widen access and participation.
Objectives: To determine the effectiveness of home-based cardiac rehabilitation programmes compared with supervised centre-based cardiac rehabilitation on mortality and morbidity, health-related quality of life and modifiable cardiac risk factors in patients with coronary heart disease.
Selection criteria: Randomised controlled trials (RCTs) that compared centre-based cardiac rehabilitation (e.g. hospital, gymnasium, sports centre) with home-based programmes, in adults with myocardial infarction, angina, heart failure or who had undergone revascularisation.
Background: Surgery of primary tumour is the backbone of colorectal cancer treatment (CRC). But in stage III cancer, metastatic or local relapse is often observed (50%). So, adjuvant treatment is always considered in this setting. The best treatment duration of hypothetic disease is not easy to define. Adjuvant chemotherapy for CRC actually lasts 6 months. The choice of optimal duration is based upon old studies using 5-fluorouracil (5FU). During the last ten years, results of major randomized controlled studies (RCTs) comparing different durations of treatments and different schedules in adjuvant setting were published. Several studies compared a 6-month chemotherapy with a longer treatment. Conversely, a single study by Chau et al compared a 6 month chemotherapy with continuous treatment lasting 3 months. But the optimal duration of these chemotherapies could be challenged. Even though the optimal duration of chemotherapy in CRC is a major issue, it has never been answered adequately.
Objectives: To evaluate the optimal duration of adjuvant treatment, we performed a meta-analysis of all RCTs comparing two durations of adjuvant treatment, 6 months versus 9 to 12 months.
Selection criteria: Patients with surgically resected colorectal cancer with high risk of recurrence.
Background: In many countries of the industrialised world second generation ('atypical') antipsychotic drugs have become the first line drug treatment for people with schizophrenia. It is not clear how the effects of the various second generation antipsychotic drugs differ.
Objectives: To evaluate the effects of quetiapine compared with other second generation antipsychotic drugs for people with schizophrenia and schizophrenia-like psychosis.
Selection criteria: We included all randomised control trials comparing oral quetiapine with oral forms of amisulpride, aripiprazole, clozapine, olanzapine, risperidone, sertindole, ziprasidone or zotepine in people with schizophrenia or schizophrenia-like psychosis.
Background: In many countries of the industrialised world second generation (atypical) antipsychotics have become first line drug treatments for people with schizophrenia. The question as to whether, and if so how much, the effects of the various second generation antipsychotics differ is a matter of debate. In this review we examine how the efficacy and tolerability of amisulpride differs from that of other second generation antipsychotics.
Objectives: To evaluate the effects of amisulpride compared with other atypical antipsychotics for people with schizophrenia and schizophrenia-like psychoses.
Selection criteria: We included randomised, at least single-blind, trials comparing oral amisulpride with oral forms of aripiprazole, clozapine, olanzapine, quetiapine, risperidone, sertindole, ziprasidone or zotepine in people with schizophrenia or schizophrenia-like psychoses.
Background: Opioid therapy for chronic noncancer pain (CNCP) is controversial due to concerns regarding long-term effectiveness and safety, particularly the risk of tolerance, dependence, or abuse.
Objectives: To assess safety, efficacy, and effectiveness of opioids taken long-term for CNCP.
Selection criteria: We searched for studies that: collected efficacy data on participants after at least 6 months of treatment; were full-text articles; did not include redundant data; were prospective; enrolled at least 10 participants; reported data of participants who had CNCP. Randomized controlled trials (RCTs) and pre-post case-series studies were included.
Background: Back pain is a common disorder that has a tendency to recur. It is unclear if exercises, either as part of treatment or as a post-treatment programme, can reduce back pain recurrences.
Objectives: To investigate the effectiveness of exercises for preventing new episodes of low-back pain or low-back pain-associated disability.
Selection criteria: Inclusion criteria were: participants who had experienced back pain before, an intervention that consisted of exercises without additional specific treatment and outcomes that measured recurrence of back pain or time to recurrence.
Background: Pilonidal sinus arises in the hair follicles in the buttock cleft. The estimated incidence is 26 per 100,000, people, affecting men twice as often as women. These chronic discharging wounds cause pain and impact upon quality of life. Surgical strategies centre on excision of the sinus tracts followed by primary closure and healing by primary intention or leaving the wound open to heal by secondary intention. There is uncertainty as to whether open or closed surgical management is more effective.
Objectives: To determine the relative effects of open compared with closed surgical treatment for pilonidal sinus on the outcomes of time to healing, infection and recurrence rate.
Selection criteria: All randomised controlled trials (RCTs) comparing open with closed surgical treatment for pilonidal sinus. Exclusion criteria were: non-RCTs; children aged younger than 14 years and studies of pilonidal abscess.
Background: Imaging is commonly performed for musculoskeletal conditions. Identifying interventions to improve the appropriate use of imaging for musculoskeletal conditions could potentially result in improved health outcomes for patients and reduced health care costs.
Objectives: To determine the effects of interventions that aim to improve the appropriate use of imaging for people with musculoskeletal conditions.
Selection criteria: Randomised controlled trials, non-randomised controlled clinical trials and interrupted time-series analyses that evaluated interventions designed to improve the use of imaging for musculoskeletal symptoms.
Background: Chronic musculoskeletal pain (CMP) is a major health problem, accounting for approximately one-quarter of general practice (GP) consultations in the United Kingdom (UK). Exercise and physical activity is beneficial for the most common types of CMP, such as back and knee pain. However, poor adherence to exercise and physical activity may limit long-term effectiveness.
Objectives: To assess the effects of interventions to improve adherence to exercise and physical activity for people with chronic musculoskeletal pain.
Selection criteria: Randomised or quasi-randomised trials evaluating interventions that aimed to improve adherence to exercise and physical activity in adults with pain for three months and over in the axial skeleton or large peripheral joints.
Background: Corticosteroids are commonly used in treatment of acute and chronic graft-versus-host disease (GvHD). Nevertheless, there has been no systematic analysis of effects of their use on the patients' survival and quality of life.
Objectives: To compare the effect of corticosteroids in treatment of patients with GvHD and to compare the effect of different regimens of corticosteroids.
Selection criteria: Randomized controlled trials of any language were included in the study as long as they met any of the predefined comparisons of interest. The primary outcome in question was the overall survival of the patients. Due to lack of evidence, inclusion criteria was revised during the process of the review to include studies comparing different dosage of corticosteroids.
Background: Treatments for Barrett's oesophagus, the precursor lesion of adenocarcinoma, are available but whether these therapies effectively prevent the development of adenocarcinoma, and in some cases eradicate the Barrett's oesophagus segment, remains unclear.
Objectives: To summarise, quantify and compare the efficacy of pharmacological, surgical and endoscopic treatments for the eradication of dysplastic and non-dysplastic Barrett's oesophagus and prevention of these states from progression to adenocarcinoma.
Selection criteria: Randomised controlled trials (RCTs) comparing medical, endoscopic or non-resectional surgical treatments for Barrett's oesophagus. The primary outcome measures were complete eradication of Barrett's and dysplasia at 12 months, and reduction in the number of patients progressing to cancer at five years or latest time point.