TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Most people who are newly diagnosed with non-small cell lung cancer (NSCLC) have advanced disease. For these people, survival is determined by various patient- and tumor-related factors, of which the performance status (PS) is the most important prognostic factor. People with PS 0 or 1 are usually treated with systemic therapies, whereas people with PS 3 or 4 most often receive supportive care. However, treatment for people with PS 2 without a targetable mutation remains unclear. Historically, people with a PS 2 cancer are frequently excluded from (important) clinical trials because of poorer outcomes and increased toxicity. We aim to address this knowledge gap, as this group of people represents a significant proportion (20% to 30%) of the total population with newly diagnosed lung cancer.
Objectives: To identify the best first-line therapy for advanced lung cancer in people with performance status 2 without a targetable mutation or with an unknown mutation status.
Selection criteria: We included randomized controlled trials (RCTs) that compared different chemotherapy (with or without angiogenesis inhibitor) or immunotherapy regimens, specifically designed for people with PS 2 only or studies including a subgroup of these people.
Background: Depression is an important morbidity associated with stroke that impacts on recovery, yet is often undetected or inadequately treated.
Objectives: To evaluate the benefits and harms of pharmacological intervention, non-invasive brain stimulation, psychological therapy, or combinations of these to treat depression after stroke.
Selection criteria: Randomised controlled trials (RCTs) comparing: 1) pharmacological interventions with placebo; 2) non-invasive brain stimulation with sham stimulation or usual care; 3) psychological therapy with usual care or attention control; 4) pharmacological intervention and psychological therapy with pharmacological intervention and usual care or attention control; 5) pharmacological intervention and non-invasive brain stimulation with pharmacological intervention and sham stimulation or usual care; 6) non-invasive brain stimulation and psychological therapy versus sham brain stimulation or usual care and psychological therapy; 7) pharmacological intervention and psychological therapy with placebo and psychological therapy; 8) pharmacological intervention and non-invasive brain stimulation with placebo and non-invasive brain stimulation; and 9) non-invasive brain stimulation and psychological therapy versus non-invasive brain stimulation and usual care or attention control, with the intention of treating depression after stroke.
Background: Cancer of ovarian, fallopian tube and peritoneal origin, referred to collectively as ovarian cancer, is the eighth most common cancer in women and is often diagnosed at an advanced stage. Women with relapsed epithelial ovarian cancer (EOC) are less well and have a limited life expectancy, therefore maintaining quality of life with effective symptom control is an important aim of treatment. However, the unwanted effects of chemotherapy agents may be severe, and optimal treatment regimens are unclear. Pegylated liposomal doxorubicin (PLD), which contains a cytotoxic drug called doxorubicin hydrochloride, is one of several treatment modalities that may be considered for treatment of relapsed EOCs. This is an update of the original Cochrane Review which was published in Issue 7, 2013.
Objectives: To evaluate the efficacy and safety of PLD, with or without other anti-cancer drugs, in women with relapsed high grade epithelial ovarian cancer (EOC).
Selection criteria: We included randomised controlled trials (RCTs) that evaluated PLD in women diagnosed with relapsed epithelial ovarian cancer.
Background: Cognitive impairments affect functional ability in people with dementia. Cognitive rehabilitation (CR) is a personalised, solution-focused approach that aims to enable people with mild-to-moderate dementia to manage everyday activities and maintain as much independence as possible.
Objectives: To evaluate the effects of CR on everyday functioning and other outcomes for people with mild-to-moderate dementia, and on outcomes for care partners. To identify and explore factors that may be associated with the efficacy of CR.
Selection criteria: We included randomised controlled trials (RCTs) comparing CR with control conditions and reporting relevant outcomes for the person with dementia and/or the care partner.
Background: Routine monitoring of gastric residuals in preterm infants on tube feeds is a common practice in neonatal intensive care units used to guide initiation and advancement of enteral feeding. There is a paucity of consensus on whether to re-feed or discard the aspirated gastric residuals. While re-feeding gastric residuals may aid in digestion and promote gastrointestinal motility and maturation by replacing partially digested milk, gastrointestinal enzymes, hormones, and trophic substances, abnormal residuals may result in vomiting, necrotising enterocolitis, or sepsis.
Objectives: To assess the efficacy and safety of re-feeding when compared to discarding gastric residuals in preterm infants.
Selection criteria: We selected RCTs that compared re-feeding versus discarding gastric residuals in preterm infants.
Background: Globally, cardiovascular diseases (CVD, that is, coronary heart (CHD) and circulatory diseases combined) contribute to 31% of all deaths, more than any other cause. In line with guidance in the UK and globally, cardiac rehabilitation programmes are widely offered to people with heart disease, and include psychosocial, educational, health behaviour change, and risk management components. Social support and social network interventions have potential to improve outcomes of these programmes, but whether and how these interventions work is poorly understood.
Objectives: To assess the effectiveness of social network and social support interventions to support cardiac rehabilitation and secondary prevention in the management of people with heart disease. The comparator was usual care with no element of social support (i.e. secondary prevention alone or with cardiac rehabilitation).
Selection criteria: We included randomised controlled trials (RCTs) of social network or social support interventions for people with heart disease. We included studies regardless of their duration of follow-up, and included those reported as full text, published as abstract only, and unpublished data.
Background: Cataract is the leading cause of blindness in the world and, as such, cataract surgery is one of the most commonly performed operations globally. Surgical techniques have changed dramatically over the past half century with associated improvements in outcomes and safety. Femtosecond lasers can be used to perform the key steps in cataract surgery, such as corneal incisions, lens capsulotomy and fragmentation. The potential advantage of femtosecond laser-assisted cataract surgery (FLACS) is greater precision and reproducibility of these steps compared to manual techniques. The disadvantages are the costs associated with FLACS technology.
Objectives: To compare the effectiveness and safety of FLACS with standard ultrasound phacoemulsification cataract surgery (PCS) by gathering evidence from randomised controlled trials (RCTs).
Selection criteria: We included RCTs where FLACS was compared to PCS.
Background: Premenstrual syndrome (PMS) is a common problem. Premenstrual dysphoric disorder (PMDD) is a severe form of premenstrual syndrome. Combined oral contraceptives (COC), which provide both progestin and oestrogen, have been examined for their ability to relieve premenstrual symptoms. A combined oral contraceptive containing drospirenone and a low oestrogen dose has been approved for treating PMDD in women who choose combined oral contraceptives for contraception.
Objectives: To evaluate the effectiveness and safety of COCs containing drospirenone in women with PMS.
Selection criteria: We included randomised controlled trials (RCT) that compared COCs containing drospirenone with placebo or with another COC for treatment of women with PMS.
Background: Neonates might be exposed to numerous painful procedures due to diagnostic reasons, therapeutic interventions, or surgical procedures. Options for pain management include opioids, non-pharmacological interventions, and other drugs. Morphine, fentanyl, and remifentanil are the opioids most often used in neonates. However, negative impact of opioids on the structure and function of the developing brain has been reported.
Objectives: To evaluate the benefits and harms of opioids in term or preterm neonates exposed to procedural pain, compared to placebo or no drug, non-pharmacological intervention, other analgesics or sedatives, other opioids, or the same opioid administered by a different route.
Selection criteria: We included randomized controlled trials conducted in preterm and term infants of a postmenstrual age (PMA) up to 46 weeks and 0 days exposed to procedural pain where opioids were compared to 1) placebo or no drug; 2) non-pharmacological intervention; 3) other analgesics or sedatives; 4) other opioids; or 5) the same opioid administered by a different route.
Background: Benign prostatic hyperplasia (BPH) is a non-malignant enlargement of the prostate, which can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH is common. The extract of the berry of the American saw palmetto or dwarf palm plant, Serenoa repens (SR), which is also known by its botanical name of Sabal serrulatum, is one of several phytotherapeutic agents available for the treatment of BPH.
Objectives: To assess the effects of Serenoa repens in the treatment of men with LUTS consistent with BPH.
Selection criteria: We included randomized controlled trials of participants with BPH who were treated with Serenoa repens or placebo/no treatment.
Background: The prevalence of obesity is increasing worldwide, yet nutritional management remains contentious. It has been suggested that low glycaemic index (GI) or low glycaemic load (GL) diets may stimulate greater weight loss than higher GI/GL diets or other weight reduction diets. The previous version of this review, published in 2007, found mainly short-term intervention studies. Since then, randomised controlled trials (RCTs) with longer-term follow-up have become available, warranting an update of this review.
Objectives: To assess the effects of low glycaemic index or low glycaemic load diets on weight loss in people with overweight or obesity.
Selection criteria: We included RCTs with a minimum duration of eight weeks comparing low GI/GL diets to higher GI/GL diets or any other diets in people with overweight or obesity.
Background: Allogeneic haematopoietic stem cell transplantation (SCT) is an established treatment for many malignant and non-malignant haematological disorders. Graft-versus-host disease (GVHD), a condition frequently occurring after an allogeneic SCT, is the result of host tissues being attacked by donor immune cells. It affects more than half of the patients after transplant either as acute and or chronic GVHD. One strategy for the prevention of GVHD is the administration of anti-thymocyte globulins (ATGs), a set of polyclonal antibodies directed against a variety of immune cell epitopes, leading to immunosuppression and immunomodulation.
Objectives: To assess the effect of ATG used for the prevention of GVHD in patients undergoing allogeneic SCT with regard to overall survival, incidence and severity of acute and chronic GVHD, incidence of relapse, non-relapse mortality, graft failure and adverse events.
Selection criteria: We included randomised controlled trials (RCTs) investigating the impact of ATG on GVHD prophylaxis in adults suffering from haematological diseases and undergoing allogeneic SCT. The selection criteria were modified from the previous version of this review. Paediatric studies and studies where patients aged < 18 years constituted more than 20 % of the total number were excluded. Treatment arms had to differ only in the addition of ATG to the standard GVHD prophylaxis regimen.
Background: Endometriosis is a common gynaecological condition affecting 6 to 11% of reproductive-age women and may cause dyspareunia, dysmenorrhoea, and infertility. One treatment strategy is medical therapy with gonadotrophin-releasing hormone analogues (GnRHas) to reduce pain due to endometriosis. One of the adverse effects of GnRHas is a decreased bone mineral density. In addition to assessing the effect on pain, quality of life, most troublesome symptom and patients' satisfaction, the current review also evaluated the effect on bone mineral density and risk of adverse effects in women with endometriosis who use GnRHas versus other treatment options.
Objectives: To assess the effectiveness and safety of GnRH analogues (GnRHas) in the treatment of painful symptoms associated with endometriosis and to determine the effects of GnRHas on bone mineral density of women with endometriosis.
Selection criteria: We included randomised controlled trials (RCTs) which compared GnRHas with other hormonal treatment options, including analgesics, danazol, intra-uterine progestogens, oral or injectable progestogens, gestrinone and also GnRHas compared with no treatment or placebo. Trials comparing GnRHas versus GnRHas in conjunction with add-back therapy (hormonal or non-hormonal) or calcium-regulation agents were also included in this review.
Background: Deviation from a normal bite can be defined as malocclusion. Orthodontic treatment takes 20 months on average to correct malocclusion. Accelerating the rate of tooth movement may help to reduce the duration of orthodontic treatment and associated unwanted effects including orthodontically induced inflammatory root resorption (OIIRR), demineralisation and reduced patient motivation and compliance. Several non-surgical adjuncts have been advocated with the aim of accelerating the rate of orthodontic tooth movement (OTM).
Objectives: To assess the effect of non-surgical adjunctive interventions on the rate of orthodontic tooth movement and the overall duration of treatment.
Selection criteria: We included randomised controlled trials (RCTs) of people receiving orthodontic treatment using fixed or removable appliances along with non-surgical adjunctive interventions to accelerate tooth movement. We excluded split-mouth studies and studies that involved people who were treated with orthognathic surgery, or who had cleft lip or palate, or other craniofacial syndromes or deformities.
Background: Preterm infants (< 37 weeks' post-menstrual age (PMA)) are often delayed in attaining oral feeding. Normal oral feeding is suggested as an important outcome for the timing of discharge from the hospital and can be an early indicator of neuromotor integrity and developmental outcomes. A range of oral stimulation interventions may help infants to develop sucking and oromotor co-ordination, promoting earlier oral feeding and earlier hospital discharge. This is an update of our 2016 review.
Objectives: To determine the effectiveness of oral stimulation interventions for attainment of oral feeding in preterm infants born before 37 weeks' PMA.
Selection criteria: Randomised and quasi-randomised controlled trials comparing a defined oral stimulation intervention with no intervention, standard care, sham treatment or non-oral intervention (e.g. body stroking protocols or gavage adjustment protocols) in preterm infants and reporting at least one of the specified outcomes.
Background: Mortality and morbidity due to neonatal sepsis and necrotising enterocolitis (NEC) remain high despite the use of potent antimicrobial agents. Agents that modulate inflammation may improve outcomes. Pentoxifylline (PTX), a phosphodiesterase inhibitor, is one such agent. This is an update of a review first published in 2003 and updated in 2011 and 2015.
Objectives: To assess the effectiveness and safety of intravenous PTX as an adjunct to antibiotic therapy on mortality and morbidity in neonates with suspected or confirmed sepsis and neonates with NEC.
Selection criteria: We included randomised controlled trials (RCTs) or quasi-RCTs assessing the efficacy of PTX with antibiotics (any dose or duration) for treatment of suspected or confirmed sepsis or NEC in neonates. We included three comparisons: (1) PTX with antibiotics compared to placebo or no intervention with antibiotics; (2) PTX with antibiotics compared to PTX with antibiotics and adjunct treatments such as immunoglobulin M-enriched intravenous immunoglobulin (IgM-enriched IVIG); (3) PTX with antibiotics compared to adjunct treatments such as IgM-enriched IVIG with antibiotics.
Background: Nicotine replacement therapy (NRT) aims to replace nicotine from cigarettes. This helps to reduce cravings and withdrawal symptoms, and ease the transition from cigarette smoking to complete abstinence. Although there is high-certainty evidence that NRT is effective for achieving long-term smoking abstinence, it is unclear whether different forms, doses, durations of treatment or timing of use impacts its effects.
Objectives: To determine the effectiveness and safety of different forms, deliveries, doses, durations and schedules of NRT, for achieving long-term smoking cessation.
Selection criteria: We included randomised trials in people motivated to quit, comparing one type of NRT use with another. We excluded studies that did not assess cessation as an outcome, with follow-up of fewer than six months, and with additional intervention components not matched between arms. Separate reviews cover studies comparing NRT to control, or to other pharmacotherapies.
Background: Postoperative pancreatic fistula (POPF) is one of the most frequent and potentially life-threatening complications following pancreatic surgery. Fibrin sealants have been used in some centres to reduce POPF rate. However, the use of fibrin sealant during pancreatic surgery is controversial. This is an update of a Cochrane Review last published in 2020.
Objectives: To evaluate the benefits and harms of fibrin sealant use for the prevention of POPF (grade B or C) in people undergoing pancreatic surgery compared to no fibrin sealant use.
Selection criteria: We included all randomised controlled trials (RCTs) that compared fibrin sealant (fibrin glue or fibrin sealant patch) versus control (no fibrin sealant or placebo) in people undergoing pancreatic surgery.
Background: Routine monitoring of gastric residual in preterm infants on gavage feeds is a common practice used to guide initiation and advancement of feeds. It is believed that an increase in or an altered gastric residual may be predictive of necrotising enterocolitis (NEC). Withholding monitoring of gastric residual may take away the early indicator and thus may increase the risk of NEC. However, routine monitoring of gastric residual as a guide, in the absence of uniform standards, may lead to unnecessary delay in initiation and advancement of feeds and hence might result in a delay in establishing full enteral feeds. This in turn may increase the duration of total parenteral nutrition (TPN) and central venous line usage, increasing the risk of associated complications. Furthermore, delays in establishing full enteral feeds increase the risk of extrauterine growth restriction and neurodevelopmental impairment.
Objectives: • To assess the efficacy and safety of routine monitoring versus no monitoring of gastric residual in preterm infants • To assess the efficacy and safety of routine monitoring of gastric residual based on two different criteria for interrupting feeds or decreasing feed volume in preterm infants
Selection criteria: We selected RCTs that compared routine monitoring versus no monitoring of gastric residual and trials that used two different criteria for gastric residual to interrupt feeds in preterm infants.
Background: Continual improvement in adjuvant therapies has resulted in a better prognosis for women diagnosed with breast cancer. A surrogate marker used to detect the spread of disease after treatment of breast cancer is local and regional recurrence. The risk of local and regional recurrence after mastectomy increases with the number of axillary lymph nodes affected by cancer. There is a consensus to use radiotherapy as an adjuvant treatment after mastectomy (postmastectomy radiotherapy (PMRT)) in women diagnosed with breast cancer and found to have disease in four or more positive axillary lymph nodes. Despite data showing almost double the risk of local and regional recurrence in women treated with mastectomy and found to have one to three positive lymph nodes, there is a lack of international consensus on the use of PMRT in this group.
Objectives: To assess the effects of PMRT in women diagnosed with early breast cancer and found to have one to three positive axillary lymph nodes.
Selection criteria: We included randomised controlled trials (RCTs). The inclusion criteria included women diagnosed with breast cancer treated with simple or modified radical mastectomy and axillary surgery (sentinel lymph node biopsy (SLNB) alone or those undergoing axillary lymph node clearance with or without prior SLNB). We included only women receiving PMRT using X-rays (electron and photon radiation), and we defined the radiotherapy dose to reflect what is currently being recommended (i.e. 40 Gray (Gy) to 50 Gy in 15 to 25/28 fractions in 3 to 5 weeks. The included studies did not administer any boost to the tumour bed. In this review, we excluded studies using neoadjuvant chemotherapy as a supportive treatment before surgery.
Background: One-third of people with gastrointestinal disorders, including functional dyspepsia, use some form of complementary and alternative medicine, including herbal medicines.
Objectives: The primary objective is to assess the effects of non-Chinese herbal medicines for the treatment of people with functional dyspepsia.
Selection criteria: We included RCTs comparing non-Chinese herbal medicines versus placebo or other treatments in people with functional dyspepsia.
Background: Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review.
Objectives: To investigate efficacy and tolerability of nebulised hypertonic saline treatment in people with cystic fibrosis (CF) compared to placebo or other treatments that enhance mucociliary clearance.
Selection criteria: We included randomised and quasi-randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity).