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Showing "2019 Anal Fissure Clinical Trials Guide Companies Drugs" PubMed Articles 1–25 of 39,000+

New Drugs and Clinical Trials Rules, 2019: The market trumps ethics and participant rights.

The enactment of the New Drugs and Clinical Trials Rules, 2019 (hereafter New Rules), on March 19 by the Ministry of Health and Family Welfare (MoHFW), Government of India (1), is the use of power delegated to the political executive by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940. Has this power been used wisely? Whose interests do these rules represent?

Lateral internal sphincterotomy for chronic anal fissure under perianal anaesthetic infiltration - video vignette.

There are a large number of treatment options for chronic anal fissure and choice of the most appropriate treatment may be difficult. Lateral sphincterotomy (LS) was described more than 60 years ago and has been widely adopted by surgeons worldwide [1]. Although this procedure gives good results, with healing of the fissure and so high patient satisfaction, the risk of incontinence should be always be kept in mind [2]. LS should be the next step in treating chronic fissures when the medical treatment is uns...

Comparison and Clinical Evaluation of Two Pit and Fissure Sealants on Permanent Mandibular First Molars: An Study.

The aim of the study was to compare and evaluate the clinical efficacy of a microfilled pit and fissure sealant and a nanofilled pit and fissure sealant at 3, 6, and 12 months of interval.

What predicts successful nonoperative management with botulinum toxin for anal fissure?

Botulinum toxin has been established as a non-surgical alternative for chronic anal fissures. There is a paucity of data regarding which patients benefit most from this intervention.

Meeting abstracts from the 5th International Clinical Trials Methodology Conference (ICTMC 2019) : Brighton, UK. 06-09 October 2019.

Tyrosine kinase inhibitors for the treatment of rheumatoid arthritis: phase I to Ⅱ clinical trials.

: Rheumatoid arthritis (RA) is a chronic, refractory disorder caused by autoimmunity in the synovial joints. Disease-modifying anti-rheumatic drugs (DMARDs) and biologicals offer remission in only two-thirds of RA patients within 3 months, hence new therapeutic approaches are necessary. Tyrosine kinase inhibitors (TKIs) are newly developed small molecule drugs which have demonstrated encouraging results in this disease.: The key findings from phase I and II clinical trials that have investigated the use of ...

Supplementary Anal Imaging by Magnetic Resonance Enterography in Patients with Crohn's Disease Not Suspected of Having Perianal Fistulas.

Few data are available to guide the use of anal imaging for patients with Crohn's disease (CD) who are not suspected of having perianal fistulas. We aimed to evaluate the role of anal imaging supplementary to magnetic resonance enterography (MRE) in these patients.

Key indicators of phase transition for clinical trials through machine learning.

A significant number of drugs fail during the clinical testing stage. To understand the attrition of drugs through the regulatory process, here we review and advance machine-learning (ML) and natural language-processing algorithms to investigate the importance of factors in clinical trials that are linked with failure in Phases II and III. We find that clinical trial phase transitions can be predicted with an average accuracy of 80%. Identifying these trials provides information to sponsors facing difficult...

Huntington's Disease Clinical Trials Corner: June 2019.

In this edition of the Huntington's Disease Clinical Trials Corner we expand on the HD-DBS and on the TRIHEP3 trials, and we list all currently registered and ongoing clinical trials in Huntington's disease.

Pooled Analysis of external-beam RADiotherapy parameters in phase II and phase III trials in radiochemotherapy in Anal Cancer (PARADAC).

Concomitant external-beam radiochemotherapy (5-fluorouracil-mitomycin C) has become the standard of care in anal cancer since the '90s. A pooled analysis of individual patient data from 7 major trials was performed quantifying the effect of radiation therapy (RT)-related parameters on the outcome of patients with anal cancer.

US Food and Drug Administration Approvals of Drugs and Devices Based on Nonrandomized Clinical Trials: A Systematic Review and Meta-analysis.

The size of estimated treatment effects on the basis of which the US Food and Drug Administration (FDA) has approved drugs and devices with data from nonrandomized clinical trials (non-RCTs) remains unknown.

Levels of clinical condom failure for anal sex: A randomized cross-over trial.

Men who have sex with men (MSM) face a 28-fold higher risk of HIV acquisition than men who have sex with women (MSW). Condoms are the most accessible prevention method, with billions produced annually. Due to potentially high clinical failure, international regulatory agencies do not approve condoms for anal sex. This trial sought to provide data regarding approval of condoms for anal sex.

Dawn of a New Age Fissure Sealant? A Study Evaluating the Clinical Performance of Embrace WetBond and ART Sealants: Results from a Randomized Controlled Clinical Trial.

 The main purpose of this article is to evaluate the clinical performance of atraumatic restorative treatment (ART) sealant versus Embrace WetBond sealant in terms of retention and fissure caries prevention among a section of school children in the southern Indian state of Karnataka ( NCT02716558).

Cooper et al. Established search filters may miss studies when identifying randomized controlled trials. J Clin Epidemiol. 2019 Apr 13;112:12-19. doi: 10.1016/j.jclinepi.2019.04.002.

Drugs for preventing post-operative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: Network meta-analysis of randomized clinical trials and trial sequential analysis.

Different categories of drugs are used to reduce the incidence of post-operative nausea and vomiting (PONV) following laparoscopic cholecystectomy (LC). This study is a network meta-analysis of randomized clinical trials with such drugs.

Pharmacotherapy in obesity: a systematic review and meta-analysis of randomized controlled trials of anti-obesity drugs.

Obesity poses a significant increase in morbidity and mortality and thus five anti-obesity drugs have been approved currently by US FDA. Several phase 3 trials have shown a significant improvement in cardio-metabolic profile including significant weight reduction with these agents compared to placebo.Areas covered:We systematically searched the database of PubMed, Embase, The Cochrane Library and The up to September 30, 2019 and retrieved all the randomized controlled trials (RCTs) that w...

The impact of evidence from clinical trials on counselling for over-the-counter drugs: A national survey of pharmaceutical staff in German pharmacies.

Evidence from clinical trials should form the foundation of healthcare advice. Comparatively little has been investigated about the implementation of evidence in over-the-counter (OTC) counselling in community pharmacies. The objective of this study was to explore the current impact of clinical trials on OTC counselling from the perspective of pharmaceutical staff.

Emerging drugs for the treatment of noninfectious uveitis.

: Uveitis is a leading cause of visual impairment and a significant burden of blindness. Although corticosteroids and conventional immunosuppressive agents have been successfully used, these are non-specific, and their long-term use may induce significant adverse effects. : This article discusses existing local and systemic applied treatments for ocular inflammation including corticosteroids, non-biologic, and biologic disease-modifying anti-rheumatic drugs (DMARD). Potential drugs being studied in clinical...

Efficacy of flap repair for anal fistula: study protocol for a systematic review of randomized controlled trial.

Clinical trials have reported that flap repair (FR) can treat anal fistula (AF) effectively. However, no study systematically investigated its efficacy and safety for patients with AF. This study will systematically assess its efficacy and safety of AF.

Financial Ties between Authors of the Clinical Practice Guidelines and Pharmaceutical Companies: an example from Japan.

Assessment of Anal Cancer Screening Tools in Detecting High-Grade Anal Squamous Intraepithelial Lesions in Women.

The aim of the study was to evaluate the validity of anal cytology against high-resolution anoscopy in the detection of anal high-grade squamous intraepithelial lesions (HSILs) among women in a clinical setting in Puerto Rico, alone and in combination with high-risk human papillomavirus (HR-HPV) typing.

The future of clinical trials in urological oncology.

Well-designed clinical trials in urological oncology help to guide treatment decisions and aid in counselling patients, ultimately serving to improve outcomes. Since the term evidence-based medicine was first used by Gordon Guyatt in 1991, a renewed emphasis on methodology, transparent trial design and study reporting has helped to improve clinical research and in turn, the landscape of medical literature. Novel clinical trial designs (including multi-arm, multistage trials, basket and umbrella studies and ...

Comparative efficacy and acceptability of first-line drugs for the acute treatment of generalized anxiety disorder in adults: A network meta-analysis.

The guide recommends SSRI and SNRI drugs as first-line treatments for generalized anxiety disorder (GAD). Therefore, we aimed to update the evidence using network meta-analysis by comparing the efficacy and acceptability of first-line drugs. The relevant electronic databases were searched for placebo-controlled and head-to-head trials of 11 drugs used for the acute treatment of adults with GAD from 1980 up to January 1, 2019. Data on demographics, clinical, and treatment information were extracted from each...

Clinical drug development for dementia with Lewy bodies: past and present.

: Dementia with Lewy bodies (DLB) is an under-researched area despite being the second most common type of degenerative dementia after Alzheimer's disease. It is an area of unmet need with no approved symptomatic or disease-modifying therapies. The pharmacological management of DLB is complex and challenging because early trials of drugs for DLB have resulted in no demonstrable efficacy. Randomized controlled trials (RCTs) in the DLB population have only recently been initiated. Understanding results from p...

Description of vaccine clinical trials in Africa: a narrative review.

Clinical research is important in establishing the effects of health care interventions. Vaccine clinical trials are to examine the effectiveness and safety of vaccines for the prevention of diseases. Africa has a high burden of infectious diseases such as malaria, tuberculosis, HIV/AIDS, and Ebola virus disease. Here we report a database surveillance study of vaccine-related clinical trials conducted in Africa. An objective is to address and profile vaccine clinical trials conducted in Africa. Data were ex...

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