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Hydroxychloroquine efficacy and safety in preventing SARS-CoV-2 infection and COVID-19 disease severity during pregnancy (COVID-Preg): a structured summary of a study protocol for a randomised placebo controlled trial.

Raquel González, Laura García-Otero, Clara Pons-Duran, Elena Marbán-Castro, Anna Goncé, Elisa Llurba, Maria Del Mar Gil, Miguel Ángel Rodríguez-Zambrano, Haily Chen, Máximo Ramírez, Azucena Bardají, Clara Menendez,

OBJECTIVES:The primary objectives of the study are: 1. To assess the effect of hydroxychloroquine (HCQ) in reducing SARS-CoV-2 viral shedding by PCR in infected pregnant women with mild symptoms. 2. To assess the efficacy of HCQ to prevent SARS-CoV-2 infection in pregnant women in contact with an infected or suspected ... Read more >>

Trials (Trials)
[2020, 21(1):607]

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Differences in gait analysis and clinical outcome after TightRope® or screw fixation in acute syndesmosis rupture: study protocol for a prospective randomized pilot study.

Julian Doll, Stefan Waizenegger, Thomas Bruckner, Gerhard Schmidmaier, Sebastian I Wolf, Christian Fischer,

BACKGROUND:Ankle sprains and fractures are most common injuries in orthopedic and trauma surgery. The concurrent occurrence of syndesmosis ruptures in these injuries represents a more complex problem, as they often remain undetected. A proper and accurate treatment of injuries of the syndesmosis, both isolated and combined with fractures, is necessary ... Read more >>

Trials (Trials)
[2020, 21(1):606]

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TILT: Time-Lapse Imaging Trial-a pragmatic, multi-centre, three-arm randomised controlled trial to assess the clinical effectiveness and safety of time-lapse imaging in in vitro fertilisation treatment.

Priya Bhide, Arasaratnam Srikantharajah, Doris Lanz, Julie Dodds, Bonnie Collins, Javier Zamora, David Chan, Shakila Thangaratinam, Khalid S Khan,

BACKGROUND:Subfertility is a common problem for which in vitro fertilisation (IVF) treatment is commonly recommended. Success rates following IVF are suboptimal and have remained static over the last few years. This imposes a considerable financial burden on overstretched healthcare resources. Time-lapse imaging (TLI) of developing embryos in IVF treatment is ... Read more >>

Trials (Trials)
[2020, 21(1):600]

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E-Freeze - a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation: a statistical analysis plan.

Jennifer L Bell, Pollyanna Hardy, Melanie Greenland, Edmund Juszczak, Christina Cole, Abha Maheshwari, Siladitya Bhattacharya, Louise Linsell,

BACKGROUND:The E-Freeze trial is a multi-centre randomised controlled trial of fresh versus frozen embryo transfer for women undergoing in vitro fertilisation. This paper describes the statistical analysis plan for the E-Freeze trial. METHODS AND DESIGN:E-Freeze is a two-arm parallel-group, multi-centre, individually randomised controlled trial to determine if a policy of ... Read more >>

Trials (Trials)
[2020, 21(1):596]

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The efficacy of Bifidobacterium quadruple viable tablet in the treatment of diarrhea predominant irritable bowel syndrome: protocol for a randomized, double-blind, placebo-controlled, multicenter trial.

Tao Bai, Haoyu Zeng, Yanqin Long, Xiaoqing Li, Xiaohong Sun, Yu Lan, Lingling Gao, Lu Zhang, Zenghui Feng, Xiaohua Hou,

BACKGROUND:Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders characterized by recurrent abdominal pain associated with defecation or a change in bowel habits. Leading to significant negative effect on patients' quality of life and huge financial burden to health system, the management of IBS is a ... Read more >>

Trials (Trials)
[2020, 21(1):597]

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Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial.

Laurie Zawertailo, Christian S Hendershot, Rachel F Tyndale, Bernard Le Foll, Andriy V Samokhvalov, Kevin E Thorpe, Andrew Pipe, Robert D Reid, Peter Selby,

BACKGROUND:Medications for smoking cessation are currently only effective in helping a minority of smokers quit. Drug development is slow and expensive; as such, there is much interest in optimizing the effectiveness of existing treatments and medications. Current standard doses of nicotine replacement therapy are not effective for many smokers, and ... Read more >>

Trials (Trials)
[2020, 21(1):592]

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The effectiveness of radial extracorporeal shock wave therapy (rESWT), sham-rESWT, standardised exercise programme or usual care for patients with plantar fasciopathy: study protocol for a double-blind, randomised, sham-controlled trial.

Marte Heide, Marianne Mørk, Cecilie Røe, Jens Ivar Brox, Aasne Fenne Hoksrud,

BACKGROUND:Plantar fasciopathy is a common cause of plantar heel pain, with a reported prevalence of up to 10%. The choice of best practice in these patients is debated. Two randomised studies reported that radial extracorporeal shock wave therapy is effective, but a meta-analysis concluded that due to methodological limitations, the ... Read more >>

Trials (Trials)
[2020, 21(1):589]

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Internet-based psychodynamic versus cognitive behaviour therapy for adolescents with depression: study protocol for a non-inferiority randomized controlled trial (the ERiCA study).

Jakob Mechler, Karin Lindqvist, Per Carlbring, Peter Lilliengren, Fredrik Falkenström, Gerhard Andersson, Naira Topooco, Robert Johansson, Nick Midgley, Julian Edbrooke-Childs, Hanne-Sofie J Dahl, Rolf Sandell, Agneta Thorén, Randi Ulberg, Katja Lindert Bergsten, Björn Philips,

BACKGROUND:Adolescent depression is a common mental health problem and there is an urgent need for effective and accessible treatments. Internet-based interventions solve many obstacles for seeking and receiving treatment, thus increasing access to effective treatments. Internet-based cognitive behavioural therapy (ICBT) for adolescent depression has demonstrated efficacy in previous trials. In ... Read more >>

Trials (Trials)
[2020, 21(1):587]

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Protocol for a randomized controlled trial comparing wound COmplications in elective midline laparotomies after FAscia Closure using two different Techniques Of Running sutures: COFACTOR trial.

Mohamad Hadi El Charif, Zeina Hassan, Jamal Hoballah, Mohamad Khalife, Eman Sbaity,

BackgroundWound complications following midline laparotomies are common and the main source of postoperative morbidity including superficial or deep wound infection, skin dehiscence, fascia dehiscence, and incisional hernia. Abdominal closure complications are strongly associated with suture technique and material, in addition to other factors related to the patient and type of ... Read more >>

Trials (Trials)
[2020, 21:]

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INdividual Vocational and Educational Support Trial (INVEST) for young people with borderline personality disorder: study protocol for a randomised controlled trial.

Andrew M Chanen, Katie Nicol, Jennifer K Betts, Gary R Bond, Cathrine Mihalopoulos, Henry J Jackson, Katherine N Thompson, Martina Jovev, Hok Pan Yuen, Gina Chinnery, Judith Ring, Kelly Allott, Louise McCutcheon, Ashleigh P Salmon, Eoin Killackey,

BACKGROUND:The clinical onset of borderline personality disorder (BPD) usually occurs in young people (aged 12-25 years) and commonly leads to difficulty achieving and maintaining vocational (education and/or employment) engagement. While current psychosocial interventions lead to improvements in psychopathology, they have little effect upon functioning. Individual Placement and Support (IPS) is a ... Read more >>

Trials (Trials)
[2020, 21(1):583]

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The ProBio trial: molecular biomarkers for advancing personalized treatment decision in patients with metastatic castration-resistant prostate cancer.

Alessio Crippa, Bram De Laere, Andrea Discacciati, Berit Larsson, Jason T Connor, Erin E Gabriel, Camilla Thellenberg, Elin Jänes, Gunilla Enblad, Anders Ullen, Marie Hjälm-Eriksson, Jan Oldenburg, Piet Ost, Johan Lindberg, Martin Eklund, Henrik Grönberg,

BACKGROUND:Multiple therapies exist for patients with metastatic castration-resistant prostate cancer (mCRPC). However, their improvement on progression-free survival (PFS) remains modest, potentially explained by tumor molecular heterogeneity. Several prognostic molecular biomarkers have been identified for mCRPC that may have predictive potential to guide treatment selection and prolong PFS. We designed a ... Read more >>

Trials (Trials)
[2020, 21(1):579]

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Effect of hydroxychloroquine on COVID-19 prevention in cancer patients undergoing treatment: a structured summary of a study protocol for a randomised controlled trial.

Abolghasem Allahyari, Hossein Rahimi, Majid Khadem-Rezaiyan, Zahra Mozaheb, Mohsen Seddigh-Shamsi, Alireza Bary, Mostafa Kamandi, Sajad Ataei Azimi, Saeed Eslami HasanAbadi, Alireza Noferesti, Somayeh Sadat Shariatmaghani, Houshang Rafatpanah, Shohreh Khatami, Afshin Jabbar Imani, Hassan Mortazi, Mohammad Moeini Nodeh,

OBJECTIVES:In this study, we investigate the effect of hydroxychloroquine on the prevention of Novel Coronavirus Disease (COVID-19) in cancer patients being treated. TRIAL DESIGN:This is a multi-centre, two-arm, parallel-group, triple-blind, phase 2-3 randomised controlled trial. PARTICIPANTS:All patients over the age of 15 from 5 types of cancer are included in ... Read more >>

Trials (Trials)
[2020, 21(1):575]

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Postoperative analgesia of scalp nerve block with ropivacaine in pediatric craniotomy patients: a protocol for a prospective, randomized, placebo-controlled, double-blinded trial.

Wei Xiong, Lu Li, Di Bao, Yaxin Wang, Yi Liang, Pengwei Lu, Di Zhang, Gaifen Liu, Lanxin Qiao, Na Zheng, Xu Jin,

BACKGROUND:Moderate-to-severe postoperative pain following craniotomy has a high incidence in pediatric patients. Such pain may cause agitation, intracranial hypertension, epileptic seizures, and postoperative hematoma, which affect morbidity and mortality. Although scalp nerve block (SNB) achieves satisfactory pain relief except for suboccipital mid-craniotomy in adults and ropivacaine is widely used as ... Read more >>

Trials (Trials)
[2020, 21(1):580]

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Evaluation of the SPIRIT Integrated Suicide Prevention Programme: study protocol for a cluster-randomised controlled trial in rural Gujarat, India.

Soumitra Pathare, Laura Shields-Zeeman, Lakshmi Vijayakumar, Deepa Pandit, Renuka Nardodkar, Susmita Chatterjee, Jasmine Kalha, Sadhvi Krishnamoorthy, Nikhil Jain, Arjun Kapoor, Mohammad Shahjahan, Ajay Chauhan, Filip Smit,

BACKGROUND:Suicide is a major public health challenge globally and specifically in India where 36.6% and 24.3% of all suicides worldwide occur in women and men, respectively. The United Nations Sustainable Development Goals uses suicide rate as one of two indicators for Target 3.4, aimed at reducing these deaths by one ... Read more >>

Trials (Trials)
[2020, 21(1):572]

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Comparison of two methods to clear the airways of critically ill children and adults with COVID-19 infection: a structured summary of a study protocol for a pilot randomized controlled trial.

Atsushi Kawaguchi, Gabrielle Bernier, Jacques Lacroix, Saly El Salti, Matthew P Cheng, Todd C Lee, Kosar Khwaja, Philippe Jouvet,

OBJECTIVES:As there is no treatment for COVID-19 with a proven mortality benefit at this moment in the pandemic, supportive management including mechanical ventilation is the core management in an intensive care unit (ICU). It is a challenge to provide consistent care in this situation, highly demanding and leading to potential ... Read more >>

Trials (Trials)
[2020, 21(1):610]

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The curative effects of shortwave diathermy on treating Novel coronavirus (COVID-19) pneumonia: A structured summary of a study protocol for a randomised controlled trial.

Mohammad Nasb, Zulfiqar Ali Sayed Shah, Liangjiang Huang, Qian Li, Hong Chen,

OBJECTIVES:To evaluate the therapeutic effects of ultra-short-wave diathermy (SWD) on COVID-19 pneumonia. The hypothesis is that SWD may minimise pneumonic inflammation and shorten the duration of the time to positive-to-negative conversion of COVID-19 nucleic acid test. TRIAL DESIGN:This is a single centre, 2-arm (1:1 ratio), evaluator blinded, parallel group design ... Read more >>

Trials (Trials)
[2020, 21(1):609]

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ChemoPROphyLaxIs with hydroxychloroquine For covId-19 infeCtious disease (PROLIFIC) to prevent covid-19 infection in frontline healthcare workers: A structured summary of a study protocol for a randomised controlled trial.

Carmel M McEniery, Marie Fisk, Karen Miles, Fotini Kaloyirou, Evangelia Vamvaka, Annette Hubsch, Jane Smith, Ian B Wilkinson, Joseph Cheriyan,

OBJECTIVES:PRIMARY OBJECTIVE: To determine whether chemoprophylaxis with hydroxychloroquine versus placebo increases time to contracting coronavirus disease 2019 (COVID-19) in frontline healthcare workers. SECONDARY OBJECTIVES:1) To determine whether chemoprophylaxis with daily versus weekly dosing of hydroxychloroquine increases time to contracting COVID-19 disease in frontline healthcare workers. 2) To compare the number ... Read more >>

Trials (Trials)
[2020, 21(1):604]

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Protocol for a randomized controlled trial comparing wound COmplications in elective midline laparotomies after FAscia Closure using two different Techniques Of Running sutures: COFACTOR trial.

Mohamad Hadi El Charif, Zeina Hassan, Jamal Hoballah, Mohamad Khalife, Eman Sbaity,

BACKGROUND:Wound complications following midline laparotomies are common and the main source of postoperative morbidity including superficial or deep wound infection, skin dehiscence, fascia dehiscence, and incisional hernia. Abdominal closure complications are strongly associated with suture technique and material, in addition to other factors related to the patient and type of ... Read more >>

Trials (Trials)
[2020, 21(1):608]

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Esophagectomy versus definitive chemoradiotherapy for patients with clinical stage N0 and pathological stage T1b esophageal squamous cell carcinoma after endoscopic submucosal dissection: study protocol for a multicenter randomized controlled trial (Ad-ESD Trial).

Yang Yang, Yuchen Su, Xiaobin Zhang, Jun Liu, Hong Zhang, Bin Li, Rong Hua, Lijie Tan, Hezhong Chen, Zhigang Li,

BACKGROUND:Esophagectomy is still advised as an additional treatment for pathological T1b (pT1b) esophageal squamous cell carcinoma (ESCC) following attempted endoscopic resection (ER). ER followed with definitive chemoradiotherapy (dCRT) has shown increased quality of life as well as comparable oncological outcomes to esophagectomy. However, there is no well-designed phase III trial ... Read more >>

Trials (Trials)
[2020, 21(1):603]

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Development of a core outcome set for oral health services research involving dependent older adults (DECADE): a study protocol.

Sinead Watson, Julie McMullan, Paul Brocklehurst, Georgios Tsakos, Richard G Watt, Rebecca R Wassall, Andrea Sherriff, Sheena E Ramsay, Anup J Karki, Sayaka Tada, Caroline Lappin, Michael Donaldson, Gerald McKenna,

BACKGROUND:Oral healthcare service provision for dependent older adults is often poor. For dental services to provide more responsive and equitable care, evidence-based approaches are needed. To facilitate future research, the development and application of a core outcome set would be beneficial. The aim of this study is to develop a ... Read more >>

Trials (Trials)
[2020, 21(1):599]

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Hydroxychloroquine efficacy and safety in preventing SARS-CoV-2 infection and COVID-19 disease severity during pregnancy (COVID-Preg): a structured summary of a study protocol for a randomised placebo controlled trial.

Raquel González, Laura García-Otero, Clara Pons-Duran, Elena Marbán-Castro, Anna Goncé, Elisa Llurba, Maria del Mar Gil, Miguel Ángel Rodríguez-Zambrano, Haily Chen, Máximo Ramírez, Azucena Bardají, Clara Menendez,

ObjectivesThe primary objectives of the study are:1. To assess the effect of hydroxychloroquine (HCQ) in reducing SARS-CoV-2 viral shedding by PCR in infected pregnant women with mild symptoms.2. To assess the efficacy of HCQ to prevent SARS-CoV-2 infection in pregnant women in contact with an infected or suspected case.3. To ... Read more >>

Trials (Trials)
[2020, 21:]

Cited: 0 times

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ChemoPROphyLaxIs with hydroxychloroquine For covId-19 infeCtious disease (PROLIFIC) to prevent covid-19 infection in frontline healthcare workers: A structured summary of a study protocol for a randomised controlled trial.

Carmel M. McEniery, Marie Fisk, Karen Miles, Fotini Kaloyirou, Evangelia Vamvaka, Annette Hubsch, Jane Smith, Ian B. Wilkinson, Joseph Cheriyan,

ObjectivesPrimary objectiveTo determine whether chemoprophylaxis with hydroxychloroquine versus placebo increases time to contracting coronavirus disease 2019 (COVID-19) in frontline healthcare workers.Secondary objectivesTo determine whether chemoprophylaxis with daily versus weekly dosing of hydroxychloroquine increases time to contracting COVID-19 disease in frontline healthcare workers.To compare the number of COVID-19 cases between each ... Read more >>

Trials (Trials)
[2020, 21:]

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Single dose versus 24 h antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial.

Daniela Francescato Veiga, Edgard da Silva Garcia, José Wilson Moreira-Filho, Evelyne Borges de Mattos Andrade, Yara Juliano, Joel Veiga-Filho, Lydia Masako Ferreira,

BACKGROUND:Reduction mammaplasty is among the most commonly performed procedures in plastic surgery. Antibiotics are widely prescribed, on an empirical basis, to prevent surgical site infections. However, there is a lack of evidence to support its use. This trial aims to compare the influence of the use of prophylatic antibiotics as ... Read more >>

Trials (Trials)
[2020, 21(1):605]

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The cerebral mechanism of the specific and nonspecific effects of acupuncture based on knee osteoarthritis: study protocol for a randomized controlled trial.

Na Zhang, Jin-Ling Li, Chao-Qun Yan, Xu Wang, Lu-Lu Lin, Jian-Feng Tu, You-Sheng Qi, Jun-Hong Liu, Cun-Zhi Liu, Li-Qiong Wang,

BACKGROUND:Research on the effect of acupuncture has been limited. Whether the effect of acupuncture is equivalent to placebo has been the focus of debate in this field. This study will explore the specific and non-specific effects of acupuncture for knee osteoarthritis (KOA) by functional magnetic resonance imaging (fMRI). METHODS AND ... Read more >>

Trials (Trials)
[2020, 21(1):566]

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Effects of soy milk consumption on gut microbiota, inflammatory markers, and disease severity in patients with ulcerative colitis: a study protocol for a randomized clinical trial.

Omid Sadeghi, Alireza Milajerdi, Seyed Davar Siadat, Seyed Ali Keshavarz, Ali Reza Sima, Homayoon Vahedi, Peyman Adibi, Ahmad Esmaillzadeh,

BACKGROUND:Several strategies are recommended to alleviate clinical symptoms of ulcerative colitis (UC). Soy milk may affect UC through its anti-inflammatory properties. However, no study has examined the effects of soy milk consumption on gut microbiota and inflammatory biomarkers in patients with UC. The current study will be done to examine ... Read more >>

Trials (Trials)
[2020, 21(1):565]

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