TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Fluoxetine is a serotonin reuptake inhibitor indicated for major depression. It is also thought to affect weight control: this seems to happen through appetite changes resulting in decreased food intake and normalisation of unusual eating behaviours. However, the benefit-risk ratio of this off-label medication is unclear.
Objectives: To assess the effects of fluoxetine for overweight or obese adults.
Selection criteria: We included randomised controlled trials (RCTs) comparing the administration of fluoxetine versus placebo, other anti-obesity agents, non-pharmacological therapy or no treatment in overweight or obese adults without depression, mental illness or abnormal eating patterns.
Background: Semen preparation techniques for assisted reproduction, including intrauterine insemination (IUI), were developed to select the motile morphologically normal spermatozoa. The yield of many motile, morphologically normal spermatozoa might influence treatment choices and therefore outcomes.
Objectives: To compare the effectiveness of three different semen preparation techniques (gradient; swim-up; wash and centrifugation) on clinical outcomes (live birth rate; clinical pregnancy rate) in subfertile couples undergoing IUI.
Selection criteria: We included randomised controlled trials (RCTs) comparing the efficacy in terms of clinical outcomes of semen preparation techniques used for subfertile couples undergoing IUI.
Background: Catamenial epilepsy describes a worsening of seizures in relation to the menstrual cycle and may affect around 40% of women with epilepsy. Vulnerable days of the menstrual cycle for seizures are perimenstrually (C1 pattern), at ovulation (C2 pattern), and during the luteal phase (C3 pattern). A reduction in progesterone levels premenstrually and reduced secretion during the luteal phase is implicated in catamenial C1 and C3 patterns. A reduction in progesterone has been demonstrated to reduce sensitivity to the inhibitory neurotransmitter in preclinical studies, hence increasing risk of seizures. A pre-ovulatory surge in oestrogen has been implicated in the C2 pattern of seizure exacerbation, although the exact mechanism by which this surge increases risk is uncertain. Current treatment practices include the use of pulsed hormonal (e.g. progesterone) and non-hormonal treatments (e.g. clobazam or acetazolamide) in women with regular menses, and complete cessation of menstruation using synthetic hormones (e.g. medroxyprogesterone (Depo-Provera) or gonadotropin-releasing hormone (GnRH) analogues (triptorelin and goserelin)) in women with irregular menses.Catamenial epilepsy and seizure exacerbation is common in women with epilepsy, and may have a significant negative impact on quality of life. Women may not be receiving appropriate treatment for their seizures because of uncertainty regarding which treatment works best and when in the menstrual cycle treatment should be taken, as well as the possible impact on fertility, the menstrual cycle, bone health, and cardiovascular health. This review aimed to address these issues in order to inform clinical practice and future research.
Objectives: To evaluate the efficacy and tolerability of hormonal and non-hormonal treatments for seizures exacerbated by the menstrual cycle in women with regular or irregular menses. We synthesised the evidence from randomised controlled trials of hormonal and non-hormonal treatments in women with catamenial epilepsy of any pattern.
Selection criteria: We included randomised and quasi-randomised controlled trials (RCTs) of blinded or opeṉlabel design that randomised participants individually (i.e. cluster-randomised trials were excluded). We included cross-over trials if each treatment period was at least 12 weeks in length and the trial had a suitable wash-out period. Types of interventions included: women with any pattern of catamenial epilepsy who received a hormonal or non-hormonal drug intervention in addition to an existing antiepileptic drug regimen for a minimum treatment duration of 12 weeks.
Background: Neurocysticercosis is the most common parasitic infection of the brain. Epilepsy is the most common clinical presentation, though it may also present with headache, symptoms of raised intracranial pressure, hydrocephalus and ocular symptoms depending upon the localisation of the parasitic cysts. Anthelmintic drugs, anti-oedema drugs, such as steroids, and antiepileptic drugs (AEDs) form the mainstay of treatment.This is an updated version of the original Cochrane Review published in 2015, Issue 10.
Objectives: To assess the effects (benefits and harms) of AEDs for the primary and secondary prevention of seizures in people with neurocysticercosis.For the question of primary prevention, we examined whether AEDs reduce the likelihood of seizures in patients who have neurocysticercosis but have not had a seizure.For the question of secondary prevention, we examined whether AEDs reduce the likelihood of further seizures in patients who have had at least one seizure due to neurocysticercosis.As part of primary prevention studies, we also aimed to examine which AED has been found to be beneficial in people with neurocysticercosis in terms of duration, dose and side-effect profile.
Selection criteria: Randomised and quasi-randomised controlled trials.Single-blind, double-blind or unblinded studies were eligible for inclusion.
Background: Epilepsy is a common neurological condition that affects up to 1% of the population. Nearly 30% of people with epilepsy are resistant to currently available antiepileptic drugs (AEDs) and require treatment with multiple antiepileptic drugs in combination. Tiagabine is one of the newer AEDs that can be used as an adjunct (add-on) to standard AEDs.
Objectives: To evaluate the efficacy and tolerability of tiagabine when used as an add-on treatment for people with drug-resistant focal seizures.
Selection criteria: We included randomised placebo-controlled add-on trials conducted in people of any age with focal epilepsy. The studies could be double-, single-, or unblinded and of parallel or cross-over design. They had to have a minimum treatment period of eight weeks. We also included trials using an active drug control group.
Background: Governments and health systems are increasingly using mobile devices to communicate with patients and the public. Targeted digital client communication is when the health system transmits information to particular individuals or groups of people, based on their health or demographic status. Common types of targeted client communication are text messages that remind people to go to appointments or take their medicines. Other types include phone calls, interactive voice response, or multimedia messages that offer healthcare information, advice, monitoring, and support.
Objectives: To explore clients' perceptions and experiences of targeted digital communication via mobile devices on topics related to reproductive, maternal, newborn, child, or adolescent health (RMNCAH).
Selection criteria: We included studies that used qualitative methods for data collection and analysis; that explored clinets' perceptions and experiences of targeted digital communication via mobile device in the areas of RMNCAH; and were from any setting globally.
Background: Dislocation of the acromioclavicular joint is one of the most common shoulder injuries in a sport-active population. The question of whether surgery should be used remains controversial. This is an update of a Cochrane Review first published in 2010.
Objectives: To assess the effects (benefits and harms) of surgical versus conservative (non-surgical) interventions for treating acromioclavicular dislocations in adults.
Selection criteria: We included all randomised and quasi-randomised trials that compared surgical with conservative treatment of acromioclavicular dislocation in adults.
Background: In people with sickle cell disease, sickled red blood cells cause the occlusion of small blood vessels which presents as episodes of severe pain known as pain crises or vaso-occlusive crises. The pain can occur in the bones, chest, or other parts of the body, and may last several hours to days. Pain relief during crises includes both pharmacologic and non-pharmacologic treatments. The efficacy of inhaled nitric oxide in pain crises has been a controversial issue and hypotheses have been made suggesting a beneficial response due to its vasodilator properties. Yet no conclusive evidence has been presented.This review aims to evaluate the available randomised controlled studies which address this topic.
Objectives: To capture the available body of evidence evaluating the efficacy and safety of the use of inhaled nitric oxide in treating pain crises in people with sickle cell disease; and to assess the treatment's relevance, robustness, and validity, in order to better guide medical practice in the fields of haematology and palliative care (since recent literature seems to favour the involvement of palliative care for those people).
Selection criteria: Randomised and quasi-randomised trials comparing inhaled nitric oxide with placebo, or standardized way of treatment of pain crises in people with sickle cell disease.
Background: Single-shot spinal anaesthesia (SSS) and combined spinal-epidural (CSE) anaesthesia are both commonly used for caesarean section anaesthesia. Spinals offer technical simplicity and rapid onset of nerve blockade which can be associated with hypotension. CSE anaesthesia allows for more gradual onset and also prolongation of the anaesthesia through use of a catheter.
Objectives: To compare the effectiveness and adverse effects of CSE anaesthesia to single-shot spinal anaesthesia for caesarean section.
Selection criteria: We considered all published randomised controlled trials (RCTs) involving a comparison of CSE anaesthesia with single-shot spinal anaesthesia for caesarean section. We further subgrouped spinal anaesthesia as either high-dose (10 or more mg bupivacaine), or low-dose (less than 10 mg bupivacaine).
Background: Peroxisome proliferator-activated receptor gamma (PPAR-γ) agonists are insulin-sensitising drugs used for the treatment of insulin resistance. In addition to lowering glucose in diabetes, these drugs may also protect against hyperlipidaemia and arteriosclerosis, which are risk factors for stroke. This is an update of a review first published in January 2014 and subsequently updated in December 2017.
Objectives: To assess the efficacy and safety of PPAR-γ agonists in the secondary prevention of stroke and related vascular events for people with stroke or transient ischaemic attack (TIA).
Selection criteria: We included randomised controlled trials (RCTs) evaluating PPAR-γ agonists versus placebo for the secondary prevention of stroke and related vascular events in people with stroke or TIA, with the outcomes of recurrent stroke, vascular events, and adverse events.
Background: Urolithiasis is a condition where crystalline mineral deposits (stones) form within the urinary tract. Urinary stones can be located in any part of the urinary tract. Affected children may present with abdominal pain, blood in the urine or signs of infection. Radiological evaluation is used to confirm the diagnosis, to assess the size of the stone, its location, and the degree of possible urinary obstruction.
Objectives: To assess the effects of different medical and surgical interventions in the treatment of urinary tract stones of the kidney or ureter in children.
Selection criteria: We included all randomised controlled trials (RCTs) and quasi-RCTs looking at interventions for upper urinary tract stones in children. These included shock wave lithotripsy, percutaneous nephrolithotripsy, ureterorenoscopy, open surgery and medical expulsion therapy for upper urinary tract stones in children aged 0 to 18 years.
Background: Women who carry a pathogenic mutation in either a BRCA1 DNA repair associated or BRCA2 DNA repair associated (BRCA1 or BRCA2) gene have a high lifetime risk of developing breast and tubo-ovarian cancer. To manage this risk women may choose to undergo risk-reducing surgery to remove breast tissue, ovaries, and fallopian tubes. Surgery should increase survival, but can impact women's lives adversely at the psychological and psychosexual levels. Interventions to facilitate psychological adjustment and improve quality of life post risk-reducing surgery are needed.
Objectives: To examine psychosocial interventions in female BRCA carriers who have undergone risk-reducing surgery and to evaluate the effectiveness of such interventions on psychological adjustment and quality of life.
Selection criteria: We included randomised controlled trials (RCT), non-randomised studies (NRS), prospective and retrospective cohort studies and interventional studies using baseline and postintervention analyses in female BRCA carriers who have undergone risk-reducing surgery.
Background: The impact of workplace interventions on the outcome of occupational asthma is not well understood.
Objectives: To evaluate the effectiveness of workplace interventions on occupational asthma.
Selection criteria: We included all eligible randomized controlled trials, controlled before and after studies and interrupted time-series of workplace interventions for occupational asthma.
Background: Cerebral palsy (CP) is the most common cause of physical disabilities in children in high-income countries. Spasticity is the most common motor disturbance in CP. Botulinum toxin type A (BoNT-A) is considered the first-line treatment for focal spasticity in people with CP.
Objectives: To evaluate the effectiveness and safety of BoNT-A compared to other treatments used in the management of lower limb spasticity in children with CP.
Selection criteria: Randomised controlled trials of children with CP, aged between birth and 19 years, treated with BoNT-A injections in the lower limb muscles compared to other interventions. The primary outcomes were gait analysis and function. The secondary outcomes were joint range of motion, quality of life, satisfaction, spasticity, and adverse events.
Background: Endometrial cancer is one of the most common gynaecological cancers in developed countries. Treatment of advanced endometrial cancer usually involves radiotherapy, chemotherapy, endocrine therapy or a combination of these. However, survival outcomes are poor in advanced or metastatic disease. Better systemic treatment options are needed to improve survival and safety outcomes for these women. The PI3K/AKT/mTOR pathway is a frequently altered signalling pathway in endometrial cancer. Single-arm studies have reported some encouraging results of the PI3K/AKT/mTOR inhibition in advanced or recurrent endometrial cancer.
Objectives: To assess the efficacy and safety of PI3K/AKT/mTOR inhibitor-containing regimens in women with locally-advanced, metastatic or recurrent endometrial cancer.
Selection criteria: We included randomised controlled trials (RCTs) comparing a regimen with a PI3K/AKT/mTOR inhibitor (either alone or in combination with other treatments, such as chemotherapy or hormonal therapy) versus a comparator regimen without a PI3K/AKT/mTOR inhibitor. There were no restrictions on which comparator(s) were included.
Background: This review represents one from a family of three reviews focusing on interventions for drug-using offenders. Many people under the care of the criminal justice system have co-occurring mental health problems and drug misuse problems; it is important to identify the most effective treatments for this vulnerable population.
Objectives: To assess the effectiveness of interventions for drug-using offenders with co-occurring mental health problems in reducing criminal activity or drug use, or both.This review addresses the following questions.• Does any treatment for drug-using offenders with co-occurring mental health problems reduce drug use?• Does any treatment for drug-using offenders with co-occurring mental health problems reduce criminal activity?• Does the treatment setting (court, community, prison/secure establishment) affect intervention outcome(s)?• Does the type of treatment affect treatment outcome(s)?
Selection criteria: We included randomised controlled trials designed to prevent relapse of drug use and/or criminal activity among drug-using offenders with co-occurring mental health problems.
Background: Idiopathic toe walking (ITW) is an exclusionary diagnosis given to healthy children who persist in walking on their toes after they should typically have achieved a heel-toe gait. The literature discusses conservative and surgical interventions using a variety of treatment modalities. Young children and children without a limitation in ankle dorsiflexion (the upwards movement of the foot towards the shin of the leg) are commonly treated with conservative interventions. Older children who continue toe walking and present with limitations in ankle dorsiflexion are sometimes treated with surgical procedures. This systematic review is needed to evaluate the evidence for any intervention for the treatment of ITW. The conclusions of this review may support decision making by clinicians caring for children with ITW. It may also assist families when deciding on treatment options for their children with ITW. Many of the treatments employed have financial implications for parents or healthcare services. This review also aims to highlight any deficits in the current research base.
Objectives: To assess the effects of conservative and surgical interventions in children with ITW, specifically effects on gait normalisation, ankle range of motion, pain, frequency of recurrence, and any adverse effects.
Selection criteria: We considered randomised or quasi-randomised trials for inclusion in the review if they involved participants diagnosed with ITW gait in the absence of a medical condition known to cause toe walking, or associated with toe walking. As there is no universally accepted age group for ITW, this review includes ITW at any age, who have been toe walking for more than six months, who can or cannot walk with a heel-toe gait, and who may or may not have limited dorsiflexion of the ankle joint.
Background: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common disorder in which the two main clinical features are pelvic pain and lower urinary tract symptoms. There are currently many approaches for its management, using both pharmacological and non-pharmacological interventions. The National Institute of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) score is a validated measure commonly used to measure CP/CPPS symptoms. We considered a 25% decrease of NIH-CPSI baseline score or a six-point reduction as MCID.
Objectives: To assess the effects of pharmacological therapies for chronic prostatitis/chronic pelvic pain syndrome.
Selection criteria: We included randomised controlled trials. Inclusion criteria were men with a diagnosis of CP/CPPS. We included all available pharmacological interventions compared to placebo or in head-to-head comparisons.
Background: Vitamin D deficiency during pregnancy increases the risk of pre-eclampsia, gestational diabetes, preterm birth, and low birthweight. In a previous Cochrane Review we found that supplementing pregnant women with vitamin D alone compared to no vitamin D supplementation may reduce the risk of pre-eclampsia, gestational diabetes, and low birthweight and may increase the risk of preterm births if it is combined with calcium. However the effects of different vitamin D regimens are not yet clear.
Objectives: To assess the effects and safety of different regimens of vitamin D supplementation alone or in combination with calcium or other vitamins, minerals or nutrients during pregnancy, specifically doses of 601 international units per day (IU/d) or more versus 600 IU/d or less; and 4000 IU/d or more versus 3999 IU/d or less.
Selection criteria: Randomised trials evaluating the effect of different vitamin D regimens (dose, frequency, duration, and time of commencement of supplementation during pregnancy), alone or in combination with other nutrients on pregnancy and neonatal health outcomes. We only included trials that compared 601 IU/d or more versus 600 IU/d or less and 4000 IU/d or more versus 3999 IU/d or less. We did not include in the analysis groups that received no vitamin D, as that comparison is assessed in another Cochrane Review.
Background: Airway infection leads to progressive damage of the lungs in cystic fibrosis (CF) and oxidative stress has been implicated in the etiology. Supplementation of antioxidant micronutrients (vitamin E, vitamin C, beta-carotene and selenium) or N-acetylcysteine (NAC) as a source of glutathione, may therefore potentially help maintain an oxidant-antioxidant balance. Glutathione or NAC can also be inhaled and if administered in this way can also have a mucolytic effect besides the antioxidant effect. Current literature suggests a relationship between oxidative status and lung function. This is an update of a previously published review.
Objectives: To synthesise existing knowledge on the effect of antioxidants such as vitamin C, vitamin E, beta-carotene, selenium and glutathione (or NAC as precursor of glutathione) on lung function through inflammatory and oxidative stress markers in people with CF.
Selection criteria: Randomised and quasi-randomised controlled studies comparing antioxidants as listed above (individually or in combination) in more than a single administration to placebo or standard care in people with CF.
Background: Frey's syndrome is characterised by transient flushing and sometimes facial sweating in the area of the auriculotemporal nerve. It most commonly occurs after parotidectomy, but other causes may include submandibular gland surgery, mandibular condylar fracture, obstetric (forceps) trauma, sympathectomy and metabolic disease. Although the pathophysiology of Frey's syndrome remains controversial, the generally accepted hypothesis is that it occurs as the result of injury to the auriculotemporal nerve.There is currently no clear evidence to establish the efficacy and safety of the different methods used for the treatment of Frey's syndrome, therefore the prevention of this symptom during surgery is important. The main method used for prevention is the interposition of a graft between the skin flap and the parotid bed during surgery. Biomaterials, allograft or autograft can be used for this purpose.
Objectives: To evaluate the effects and safety of biomaterial, allograft or autograft interposition for the prevention of Frey's syndrome in patients undergoing parotidectomy, and to identify its effect on prevention and delayed occurrence.
Selection criteria: We included randomised controlled trials (RCTs) in patients with parotid disease (including tumours, inflammation, trauma etc.) undergoing parotidectomy with a minimal follow-up period of six months. We planned to include trials with interventions including biomaterial, allograft or autograft interposition alone or in combination with other surgical techniques. We included trials that compared any graft interposition and no graft interposition, or different graft interpositions.
Background: Exercise programmes are often recommended for managing ankylosing spondylitis (AS), to reduce pain and improve or maintain functional capacity.
Objectives: To assess the benefits and harms of exercise programmes for people with AS.
Selection criteria: We included reports of randomised controlled trials (RCT) of adults with AS that compared exercise therapy programmes with an inactive control (no intervention, waiting list) or usual care.