TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Atherosclerotic renal artery stenosis is the most common cause of secondary hypertension. Balloon angioplasty with stenting is widely used for the treatment of hypertensive patients with renal artery stenosis but the effectiveness of this procedure in treating hypertension, improving renal function and preventing adverse cardiovascular and renal events remains uncertain. This is an update, to include the results of recent, important large trials, of a review first published in 2003.
Objectives: To compare the effectiveness of balloon angioplasty (with and without stenting) with medical therapy for the treatment of atherosclerotic renal artery stenosis in patients with hypertension. The following outcomes were compared: blood pressure control, renal function, frequency of cardiovascular and renal adverse events, presence or absence of restenosis of the renal artery, side effects of medical therapy, numbers and defined daily doses of antihypertensive drugs.
Selection criteria: Randomised controlled trials (RCTs) comparing balloon angioplasty with medical therapy in hypertensive patients with haemodynamically significant renal artery stenosis (greater than 50% reduction in luminal diameter) and with a minimum follow-up of six months.
Background: Cardiovascular disease (CVD) remains the number one cause of death and disability worldwide and public health interventions focus on modifiable risk factors, such as diet. Coenzyme Q10 (CoQ10) is an antioxidant that is naturally synthesised by the body and can also be taken as a dietary supplement. Studies have shown that a CoQ10 deficiency is associated with cardiovascular disease.
Objectives: To determine the effects of coenzyme Q10 supplementation as a single ingredient for the primary prevention of CVD.
Selection criteria: Randomised controlled trials (RCTs) lasting at least three months involving healthy adults or those at high risk of CVD but without a diagnosis of CVD. Trials investigated the supplementation of CoQ10 alone as a single supplement. The comparison group was no intervention or placebo. The outcomes of interest were CVD clinical events and major CVD risk factors, adverse effects and costs. We excluded any trials involving multifactorial lifestyle interventions to avoid confounding.
Background: Most premature infants are physiologically not sufficiently mature to orally ingest all of their required water and nutrients. Therefore, premature infants rely on their caregivers to regulate their volume of water intake. Thus, the caregiver must determine the amount of water to be given each day to such infants.
Objectives: To determine the effect of water intake on postnatal weight loss and the risks of dehydration, patent ductus arteriosus, necrotizing enterocolitis, bronchopulmonary dysplasia, intracranial hemorrhage, and death in premature infants.
Selection criteria: Only RCTs of varying water intake in premature infants were included. The review was limited to trials that included infants whose water intake was provided mainly or entirely by intravascular infusion.
Background: Current standard treatment for patients with cervical cancer who have locally advanced stage disease (International Federation of Gynecology and Obstetrics (FIGO) stage IIB to IVA) is concurrent chemoradiation therapy (CCRT). However, less than two-thirds of patients in this group survive for longer than five years post treatment. Adjuvant chemotherapy (ACT) can be given in an attempt to improve survival by eradicating residual disease in the pelvis and treating occult disease outside the pelvic radiation field. However, inconsistency in trial design, inclusion criteria for participants, interventions and survival benefit has been noted among trials of ACT after CCRT for locally advanced cervical cancer (LACC).
Objectives: To evaluate the effect of adjuvant chemotherapy (ACT) after concurrent chemoradiation (CCRT) on survival of women with locally advanced cervical cancer compared with CCRT alone.
Selection criteria: Randomised controlled trials (RCTs) comparing CCRT alone versus CCRT plus ACT were included. Patients were diagnosed with cervical cancer FIGO stage IIB to IVA with a histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma.
Background: Depressive disorders are the most common psychiatric comorbidity in patients with epilepsy, affecting around one-third, with a significant negative impact on quality of life. There is concern that patients may not be receiving appropriate treatment for their depression because of uncertainty regarding which antidepressant or class works best and the perceived risk of exacerbating seizures. This review aims to address these issues and inform clinical practice and future research.
Objectives: We aimed to review and synthesise evidence from randomised controlled trials of antidepressants and prospective non-randomised studies of antidepressants used for treating depression in patients with epilepsy. The primary objectives were to evaluate the efficacy and safety of antidepressants in treating depressive symptoms and the effect on seizure recurrence.
Selection criteria: We included randomised controlled trials (RCTs) and prospective non-randomised cohort controlled and uncontrolled studies investigating children or adults with epilepsy treated with an antidepressant for depressive symptoms. The intervention group consisted of patients receiving an antidepressant drug in addition to an existing antiepileptic drug regimen. The control group(s) consisted of patients receiving a placebo, comparative antidepressant, psychotherapy or no treatment in addition to an existing antiepileptic drug regimen.
Background: Proton pump inhibitors (PPIs) are the most effective drugs to reduce gastric acid secretion. PPIs are one of the most commonly prescribed classes of medications worldwide. Apart from short-term application, maintenance therapy with PPIs is recommended and increasingly used in certain diseases, such as Zollinger-Ellison syndrome and gastro-oesophageal reflux disease, especially for people with erosive oesophagitis or Barrett's oesophagus. Although PPIs are generally safe, their efficacy and safety of long-term use remains unclear. The question of whether the long-term use of PPIs could promote the development of gastric pre-malignant lesions has been widely investigated, but results are inconsistent. Limited insight on this problem leads to a dilemma in decision making for long-term PPI prescription.
Objectives: To compare the development or progression of gastric pre-malignant lesions, such as atrophic gastritis, intestinal metaplasia, enterochromaffin-like (ECL) cell hyperplasia, and dysplasia, in people taking long-term (six months or greater) PPI maintenance therapy.
Selection criteria: We searched for randomised controlled trials (RCTs) in adults (aged 18 years or greater) concerning the effects of long-term (six months or greater) PPI use on gastric mucosa changes, confirmed by endoscopy or biopsy sampling (or both).
Background: Nasal polyps cause nasal obstruction, discharge and reduction in or loss of sense of smell, but their aetiology is unknown. The management of chronic rhinosinusitis with nasal polyps, aimed at improving these symptoms, includes both surgical and medical treatments, but there is no universally accepted management protocol.
Objectives: To assess the effectiveness of endonasal/endoscopic surgery versus medical treatment in chronic rhinosinusitis with nasal polyps.
Selection criteria: Randomised controlled trials of any surgical intervention (e.g. polypectomy, endoscopic sinus surgery) versus any medical treatment (e.g. intranasal and/or systemic steroids), including placebo, in adult patients with chronic rhinosinusitis with nasal polyps.
Background: The introduction of enteral feeds for very preterm (less than 32 weeks' gestation) or very low birth weight (VLBW; less than 1500 g) infants is often delayed for several days or longer after birth due to concern that early introduction may not be tolerated and may increase the risk of necrotising enterocolitis (NEC). However, delaying enteral feeding could diminish the functional adaptation of the gastrointestinal tract and prolong the need for parenteral nutrition with its attendant infectious and metabolic risks.
Objectives: To determine the effect of delayed introduction of progressive enteral feeds on the incidence of NEC, mortality and other morbidities in very preterm or VLBW infants.
Selection criteria: We included randomised or quasi-randomised controlled trials that assessed the effect of delayed (more than four days after birth) versus earlier introduction of progressive enteral feeds on the incidence of NEC, mortality and other morbidities in very preterm or VLBW infants.
Background: Drug addiction is a chronic, relapsing disease. Primary interventions should aim to reduce first use or to prevent the transition from experimental use to addiction. School is the appropriate setting for preventive interventions.
Objectives: To evaluate the effectiveness of universal school-based interventions in reducing drug use compared to usual curricular activities or no intervention.
Selection criteria: Randomised controlled trials (RCT) evaluating school-based interventions designed to prevent illicit drugs use.
Background: Depressive disorders are common in children and adolescents and, if left untreated, are likely to recur in adulthood. Depression is highly debilitating, affecting psychosocial, family and academic functioning.
Objectives: To evaluate the effectiveness of psychological therapies and antidepressant medication, alone and in combination, for the treatment of depressive disorder in children and adolescents. We have examined clinical outcomes including remission, clinician and self reported depression measures, and suicide-related outcomes.
Selection criteria: RCTs were eligible for inclusion if they compared i) any psychological therapy with any antidepressant medication, or ii) a combination of psychological therapy and antidepressant medication with a psychological therapy alone, or an antidepressant medication alone, or iii) a combination of psychological therapy and antidepressant medication with a placebo or'treatment as usual', or (iv) a combination of psychological therapy and antidepressant medication with a psychological therapy or antidepressant medication plus a placebo.We included studies if they involved participants aged between 6 and 18 years, diagnosed by a clinician as having Major Depressive Disorder (MDD) based on Diagnostic and Statistical Manual (DSM) or International Classification of Diseases (ICD) criteria.
Background: Chronic pain is frequent in persons living with spinal cord injury (SCI). Conventionally, the pain is treated pharmacologically, yet long-term pain medication is often refractory and associated with side effects. Non-pharmacological interventions are frequently advocated, although the benefit and harm profiles of these treatments are not well established, in part because of methodological weaknesses of available studies.
Objectives: To critically appraise and synthesise available research evidence on the effects of non-pharmacological interventions for the treatment of chronic neuropathic and nociceptive pain in people living with SCI.
Selection criteria: Randomised controlled trials of any intervention not involving intake of medication or other active substances to treat chronic pain in people with SCI.
Background: Fear of falling is common in older people and associated with serious physical and psychosocial consequences. Exercise (planned, structured, repetitive and purposive physical activity aimed at improving physical fitness) may reduce fear of falling by improving strength, gait, balance and mood, and reducing the occurrence of falls.
Objectives: To assess the effects (benefits, harms and costs) of exercise interventions for reducing fear of falling in older people living in the community.
Selection criteria: We included randomised and quasi-randomised trials that recruited community-dwelling people (where the majority were aged 65 and over) and were not restricted to specific medical conditions (e.g. stroke, hip fracture). We included trials that evaluated exercise interventions compared with no intervention or a non-exercise intervention (e.g. social visits), and that measured fear of falling. Exercise interventions were varied; for example, they could be 'prescriptions' or recommendations, group-based or individual, supervised or unsupervised.
Background: Sutures (stitches), staples and adhesive tapes have been used for many years as methods of wound closure, but tissue adhesives have entered clinical practice more recently. Closure of wounds with sutures enables the closure to be meticulous, but the sutures may show tissue reactivity and can require removal. Tissue adhesives offer the advantages of an absence of risk of needlestick injury and no requirement to remove sutures later. Initially, tissue adhesives were used primarily in emergency room settings, but this review looks at the use of tissue adhesives in the operating room/theatre where surgeons are using them increasingly for the closure of surgical skin incisions.
Objectives: To determine the effects of various tissue adhesives compared with conventional skin closure techniques for the closure of surgical wounds.
Selection criteria: Only randomised controlled trials were eligible for inclusion.
Background: Evidence suggests that many perimenopausal and early postmenopausal women will experience menopausal symptoms; hot flushes are the most common. Symptoms caused by fluctuating levels of oestrogen may be alleviated by hormone therapy (HT), but a marked global decline in its use has resulted from concerns about the risks and benefits of HT. Consequently, many women are seeking alternatives. As large numbers of women are choosing not to take HT, it is increasingly important to identify evidence-based lifestyle modifications that have the potential to reduce vasomotor menopausal symptoms.
Objectives: To examine the effectiveness of any type of exercise intervention in the management of vasomotor symptoms in symptomatic perimenopausal and postmenopausal women.
Selection criteria: RCTs in which any type of exercise intervention was compared with no treatment/control or other treatments in the management of menopausal vasomotor symptoms in symptomatic perimenopausal/postmenopausal women.
Background: Nearly two-thirds of women in their first postpartum year have an unmet need for family planning. Adolescents often have repeat pregnancies within a year of giving birth. Women may receive counseling on family planning both antepartum and postpartum. Decisions about contraceptive use made right after counseling may differ considerably from actual postpartum use. In earlier work, we found limited evidence of effectiveness from randomized trials on postpartum contraceptive counseling. For educational interventions, non-randomized studies may be conducted more often than randomized trials.
Objectives: We reviewed non-randomized studies of educational strategies to improve postpartum contraceptive use. Our intent was to examine associations between specific interventions and postpartum contraceptive use or subsequent pregnancy.
Selection criteria: The studies had to be comparative, i.e., have intervention and comparison groups. The educational component could be counseling or another behavioral strategy to improve contraceptive use among postpartum women. The intervention had to include contact within six weeks postpartum. The comparison condition could be another behavioral strategy to improve contraceptive use, usual care, other health education, or no intervention. Our primary outcomes were postpartum contraceptive use and subsequent pregnancy.
Background: Partial agonists are a subclass of beta blockers used to treat hypertension in many countries. Partial agonist act by stimulating beta receptors when they are quiescent and blocking beta receptors when they are active. The blood pressure (BP) lowering effect of partial agonist beta blockers has not been quantified.
Objectives: To quantify the dose-related effects of various partial agonists beta blockers on systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate versus placebo in patients with primary hypertension.
Selection criteria: Randomized double-blinded placebo-controlled parallel or cross-over trials. Studies must contain a partial agonist monotherapy arm with fixed dose. Patients enrolled into the studies must have primary hypertension at baseline (defined as SBP/DBP > 140/90 mmHg). Duration of studies must be between three to 12 weeks.
Background: Ankylosing spondylitis (AS) is a chronic inflammatory disease of unknown cause and affects mainly the spine, but can also affect other joints. Disease progression may result in loss of mobility and function. Sulfasalazine is a disease-modifying antirheumatic drug used in the treatment of AS. However, its efficacy remains unclear. This is an update of a Cochrane review first published in 2005.
Objectives: To evaluate the benefits and harms of sulfasalazine for the treatment of ankylosing spondylitis (AS).
Selection criteria: We evaluated randomized and quasi-randomized trials examining the benefits and harms of sulfasalazine on AS.
Background: Thoracic outlet syndrome (TOS) is one of the most controversial diagnoses in clinical medicine. Despite many reports of operative and non-operative interventions, rigorous scientific investigation of this syndrome leading to evidence-based management is lacking. This is the first update of a review first published in 2010.
Objectives: To evaluate the beneficial and adverse effects of the available operative and non-operative interventions for the treatment of TOS a minimum of six months after the intervention.
Selection criteria: We selected randomized or quasi-randomized studies involving participants with the diagnosis of TOS of any type (neurogenic, vascular, and 'disputed'), without limitations as to language of publication.We accepted studies that examined any intervention aimed at treating TOS.The primary outcome measure was change in pain rating, measured on a validated visual analog or similar scale at least six months after the intervention.The secondary outcomes were change in muscle strength, disability, experiences of paresthesias (numbness and tingling sensations), and adverse effects of the interventions.
Background: Fractures of the olecranon (the bony tip of the elbow) account for approximately 1% of all upper extremity fractures. Surgical intervention is often required to restore elbow function. Two key methods of surgery are tension band wire fixation and plate fixation.
Objectives: To assess the effects (benefits and harms) of different surgical interventions in the treatment of olecranon fractures in adults.
Selection criteria: Randomised controlled trials (RCT) and quasi-RCTs that compared different surgical interventions for the treatment of olecranon fractures in adults.
Background: Rubefacients containing salicylates cause irritation of the skin and are believed to relieve various musculoskeletal pains. They are available on prescription, and are common components in over-the-counter remedies. This is an update of a review of rubefacients for acute and chronic pain, originally published in 2009, which found limited evidence for efficacy.
Objectives: To assess the efficacy and safety of topically applied salicylates in acute and chronic musculoskeletal pain in adults.
Selection criteria: Randomised, double-blind, placebo- or active-controlled clinical trials of topical rubefacients containing salicylates to treat musculoskeletal pain in adults, with at least 10 participants per treatment arm, and reporting outcomes at close to 7 (minimum 3, maximum 10) days for acute conditions and 14 (minimum 7) days or longer for chronic conditions.
Background: Health insurance has the potential to improve access to health care and protect people from the financial risks of diseases. However, health insurance coverage is often low, particularly for people most in need of protection, including children and other vulnerable populations.
Objectives: To assess the effectiveness of strategies for expanding health insurance coverage in vulnerable populations.
Selection criteria: Randomised controlled trials (RCTs), non-randomised controlled trials (NRCTs), controlled before-after (CBA) studies and Interrupted time series (ITS) studies that evaluated the effects of strategies on increasing health insurance coverage for vulnerable populations. We defined strategies as measures to improve the enrolment of vulnerable populations into health insurance schemes. Two categories and six specified strategies were identified as the interventions.
Background: Acute cough due to upper respiratory tract infection (URTI) is a common symptom. Non-prescription, over-the-counter (OTC) medicines are frequently recommended as a first-line treatment, but there is little evidence as to whether these drugs are effective.
Objectives: To assess the effects of oral OTC cough preparations for acute cough in children and adults in community settings.
Selection criteria: Randomised controlled trials (RCTs) comparing oral OTC cough preparations with placebo in children and adults suffering from acute cough in community settings. We considered all cough outcomes; secondary outcomes of interest were adverse effects.
Background: Diabetic retinopathy is a complication of diabetes in which high blood sugar levels damage the blood vessels in the retina. Sometimes new blood vessels grow in the retina, and these can have harmful effects; this is known as proliferative diabetic retinopathy. Laser photocoagulation is an intervention that is commonly used to treat diabetic retinopathy, in which light energy is applied to the retina with the aim of stopping the growth and development of new blood vessels, and thereby preserving vision.
Objectives: To assess the effects of laser photocoagulation for diabetic retinopathy compared to no treatment or deferred treatment.
Selection criteria: We included randomised controlled trials (RCTs) where people (or eyes) with diabetic retinopathy were randomly allocated to laser photocoagulation or no treatment or deferred treatment. We excluded trials of lasers that are no longer in routine use. Our primary outcome was the proportion of people who lost 15 or more letters (3 lines) of best-corrected visual acuity (BCVA) as measured on a logMAR chart at 12 months. We also looked at longer-term follow-up of the primary outcome at two to five years. Secondary outcomes included mean best corrected distance visual acuity, severe visual loss, mean near visual acuity, progression of diabetic retinopathy, quality of life, pain, loss of driving licence, vitreous haemorrhage and retinal detachment.