cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Propionibacterium Extract Gel Versus 0.4% Glyceryl Trinitrate Ointment in the Treatment of Chronic Anal Fissure: a Randomised Controlled Trial

The study compares the efficacy and safety of a Propionibacterium extract gel with 0.4% glyceryl trinitrate ointment in the treatment of chronic anal fissure.

Patients were randomly allocated to a PeG or GTN group and medication was taken every 12 hours for 40 days. Primary outcome was the success rate as measured by a decrease in the REALISE score at 10, 20 and 40 days after starting either treatment. The secondary out-comes were the healing rate, the partial or complete resolution of itching and burning, the rate of complications and adverse events, patients' quality of life and satisfaction at the same time points.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients diagnosed with chronic anal fissure aged between 18 and 75 years

Exclusion Criteria:

* Fecal incontinence
* Inflammatory bowel disease
* Previous history of anal surgery
* Previous or concomitant treatment for anal fissure, sexually transmitted disease, cancer, immune-suppressive treatment
* Current pregnancy or breastfeeding
* Known allergy to one of the agents contained into the evaluating drugs
Study of Acute Autoimmune Encephalitis With Positive Antibodies in Eastern France

The number of acute encephalitides diagnosed each year is gradually increasing, reaching approximately 5 to 10/100,000 per year; more than 50% of etiologies currently remain unknown. The majority of them are acute encephalitis of infectious origin, but it is estimated that 20% of encephalitis in northern Europe is related to an autoimmune mechanism with the majority of encephalitis with anti-NMDA Ac discovered recently in 2007. The study of a large American encephalitis cohort showed a death rate of 3% to 7% in cases of autoimmune encephalitis. Furthermore, delay in the initiation of effective treatment (tumor removal or immunotherapy) beyond 4 weeks is associated with a poor prognosis at 1 year.

It is therefore necessary to better understand the signs of autoimmune encephalitis in order to recognize the disease quickly and to start a treatment quickly; in order to improve the management and the prognosis of these children.


Eligibility Criteria:
Inclusion criteria:

* Age between 0 and 17 years at diagnosis
* Patient diagnosed between 01/01/2006 and 31/12/2018 with autoimmune encephalitis in one of the participating university hospitals (Besançon, Nancy, Strasbourg, Reims and Dijon)
* Presence of clinical criteria of clinical and/or radiographic encephalitis
* Presence of one or more antibodies in the blood or CSF
* Parental authority holders and their child of childbearing age having given their consent for the use of the child's data for this research

Exclusion criteria:

* Refusal to participate in the study
* Absence of consultation at any of the study centers
* Absence of clinical and/or radiographic criteria for encephalitis.
* Absence of antibodies found in blood or CSF
Effects of Music Combined With Sports Games on Alleviating Psychological Stress, Anxiety and Mental Energy Among Adolescents During COVID-19 Pandemic in Lanzhou Gansu Province China

The objective of this observational study was to assess whether music and sports play interventions were effective in reducing stress, anxiety and fear of COVID-19 among secondary school students in Gansu Province; The effects of music, sports games, and music combined with sports games were compared.


Eligibility Criteria:
Inclusion Criteria:

* 1. Secondary schools' students (both maile and female) in Lanzhou city, years (14-17 years old).
* 2. Able to read and understand the Chinese version questionnaires.
* 3. Understand the information explained by the researcher and agree to be included in the study.
* 4. They are in good health, measured by PAR-Q
* 5. Participants who written consent to participate in the study.

Exclusion Criteria:

* Participants with disabilities that prevent them from physically active. Also, those who withdraw in the middle or at the end of the intervention before answering the questionnaire of post-trial.
Dermoscopy in Nails

Study types and frequency of nail changes in patients with vitiligocompared to healthy subjects

Dermoscopy is a noninvasive diagnostic tool that is currently being used for different skin lesions, several inflammatory \& infectious diseases, and skin appendages disorders. ") In daily practice, dermoscopy may confirm clinical diagnosis and guides in the management of nail diseases, permitting a better visualization of symptoms. (2) Nail dermoscopy (Onychoscopy) was initially used only in the assessment of nail pigmentation, but now it is widely utilized for the evaluation of many nail disorders. (3) It enhances visible nail features; however, it can also help identify additional unique and fascinating features not visible to the naked eye. 2) Vitiligo is an acquired dyschromia of the skin in which there is loss of epidermal melanocytes The prevalence of vitiligo is approximately 0.1 - 2% worldwide. (5) Vitiligo is classified as segmental, acrofacial, generalized, and universal and less commonly mucosal and trichome.

Vitiligo has been described as a systemic disease. It has been associated with other autoimmune disorders as Diabetes (DM), Lupus, Psoriasis, Alopecia areata (AA), Hashimoto thyroiditis, and Gravesdisease.

Nails can show changes in association with many disorders such as renal, hepatic, pulmonary, autoimmune and collagen diseases. (67) Dermoscopic nail changes has been reported in several autoimmune disorders such as, in DM; longitudinal striations, pitting, onycholysis, \& splinter hemorrhage, (® in AA; scaly cuticle, punctate leukonychia, oncholysis, \&oncychoschizia®and in Collagen Vascular disorders; dilated capillaries, capillary dropout, and avascular areas. (10) To the best of our knowledge, dermoscopic nail changes in vitiligo haven't been reported yet. However, few studies had discussed clinical nail changes in vitiligo such as: (11) longitudinal ridging, absent lunula, leukonychia, pitting, in addition to less common nail changes such as flag sign and Terry's nails

Eligibility Criteria:
Inclusion Criteria:

* Age Adults patients 12-50 years old All types of vitiligo: Focal, generalized, acrofacial, segmental

Exclusion Criteria:

* patients older than 50 (because of aging's nail changes Patients with autoimmune disorders Patients using systemic medication for any reason including oral contraceptive pill
OTIVACTO Regional Center Vienna (RCV) Non-Interventional Study (NIS)

Real-world data on the effects of a fixed-dose combination Long-acting beta agonists + long-acting antimuscarinic agent (LABA+LAMA) therapy with tiotropium and olodaterol administered in a single device, in COPD patients who need treatment with two long-acting bronchodilators, is not available. This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto Respimat according to the approved Summary of Product Characteristics (SmPC).

Purpose:

Study Design:

Eligibility Criteria:
Inclusion criteria:

1. Written informed consent prior to participation
2. Female and male patients with more or equal to 40 years of age
3. Patients diagnosed with COPD and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto Respimat Summary of Product Characteristics (SmPC) and chronic obstructive pulmonary disease (COPD) Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline recommendation

Exclusion criteria:

1. Patients with contraindications according to Spiolto Respimat SmPC
2. Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 months
3. Patients continuing LABA- Inhalative Corticosteroids (ICS) treatment should not be additionally treated with Spiolto Respimat in order to avoid a double dosing of long-acting beta-agonists
4. Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks
5. Pregnancy and lactation
6. Patients currently listed for lung transplantation
7. Current participation in any clinical trial or any other non-interventional study of a drug or device
HP184 in Chronic Spinal Cord Injury Subjects

The purpose of this study is to determine whether HP184 is effective in the treatment of chronic spinal cord injury (CSCI).


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with incomplete (traumatic), chronic (defined as 18 months or more post spinal cord injury) SCI aged 18 to 65 years
* CSCI must be categorized in classes C or D in the ASIA impairment scale. (C = Incomplete impairment with motor function preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3. D = Incomplete impairment with motor function preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade more than or equal to 3).
* The level of the SCI must be between C4 and T10 (neurological)
* Subject has a measurable range of motion at the hips, knees and ankles and possesses potential propulsive activity (i.e. no functional contractures)
* Female subjects of childbearing potential (those who are not surgically sterile or who are less than 2 years postmenopausal) must be using two forms of birth control, including a primary and a secondary form and have a negative pregnancy test immediately prior to treatment. Primary forms of contraception include: tubal ligation, partner's vasectomy, intrauterine devices, birth control pills, and topical/injectable/implantable/insertable hormonal birth control products. Secondary forms of contraception include diaphragms, latex condoms and cervical caps; each must be used with a spermicide.

Exclusion Criteria:

* Any clinical evidence of recent fracture(s) within the last six months prior to study start.
* Any history of Multiple Sclerosis or peripheral demyelinating disease or neuromuscular disorder.
* Heart rate of less than 38 or greater than 100
* Ashworth spasticity score of 0/4 or 4/4 at the hip or knee.
* Subject whose medical condition requires mechanical ventilation.
* Lower motor neuron injury, such as those with conus medullaris or cauda equina injuries.
* Subject with lower extremity amputation or proximal femorectomy.
* Subject with pressure ulcers stages 3 and 4.
* Subject medically or mentally unstable in judgment of Investigator.
* Subject on tricyclic antidepressants such as nortriptyline, amitriptyline and imipramine.
* Subject with ASIA motor score of greater than or equal to 92.
* Subject with ASIA sensory score of greater than or equal to 200.
* Subject with history of seizure within 2 years prior to study start.
* Subjects who have participated in a clinical trial involving investigational medication within 30 days prior to administration of HP184 or placebo.
* Female subjects with positive urine pregnancy test.
* Female subjects who are breast feeding.
3D Craniofacial Morphologic Development of Healthy Infants

Healthy infants were enrolled to receive three dimensional craniofacial photography regularly at their age of one month, two month, four month, six month, nine month and twelve month. All the image data was analyzed to reveal infants' craniofacial development.

Importance The development of craniofacial morphology in the first year of life is critical, especially when analyzed with longitudinal 3-dimensional photographs.

Objective To evaluate the development of the craniofacial region in healthy infants in the first year of life and provide treatment guidelines for craniofacial deformities such as orofacial clefts and deformational plagiocephaly.

Design, Setting, and Participants Three-dimensional (3D) photographs of included participants were captured using a 3dMD system. Participants were grouped by sex and age (1, 2, 4, 6, 9, and 12 months). We placed 32 craniofacial anatomical landmarks on 3D craniofacial photos. The thin-plate spline algorithm and closest-point matching were applied to transform a symmetric 3D template into a series of scanned images to calculate 3D composite heads at different ages.

Main Outcomes and Measures Average craniofacial meshes were calculated for each group. The growth patterns of the following anthropometric indices were determined: craniofacial height, depth, width, volume, body height, weight, body mass index (BMI), and head circumference.

Eligibility Criteria:
Inclusion Criteria:

* Asian ethnicity
* healthy infants
* full-term

Exclusion Criteria:

* growth curve \<3%
* premature
* congenital craniofacial anomaly
* hormonal anomaly.
* chromsomal anomaly
* thyroid anomaly
* bone anomaly
Mitigation of Postoperative Delirium in High-Risk Patients

Among patients with cognitive impairment (CI) that undergo surgery, the risk for developing postoperative delirium (POD) is high (50%) and associated with further morbidity and mortality. Yet, 30-40% of POD cases are preventable with perioperative management. This randomized pragmatic clinical trial aims to assess incidence of POD in adult surgical patients with CI, as well as provider adherence to a set of 12 perioperative best practice recommendations for perioperative management. Electronic health record (EHR) data will be used to identify patients as high risk for developing POD and clinical decision support (CDS) prompts within the EHR will display best practices. Cases will be randomized to either the control group, usual care or the intervention which includes the high-risk alert and best practice prompts.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a history of cognitive impairment (CI) undergoing surgery at the Mount Sinai Health System.
* Attending physicians, resident physicians, and nurse anesthetists at the Mount Sinai Health System receiving CDS alerts during EHR system implementation.

Exclusion Criteria:

* Patients will be excluded if this not their first surgery since study start, if they do not have cognitive impairment based on EHR data, or if the surgery is for organ donation.
* There will be no exclusion criteria for providers or historical controls.
Comparing Mechanical Power in Different Inspiratory Times

We aimed to compare mechanical power and energy values using geometric methods at varying inspiratory rise times.

In this study, the researchers aim to compare the mechanical power and energy values calculated using the geometric method in Volume-Controlled Ventilation (VCV) and Pressure-Controlled Ventilation (PCV) modes at different inspiratory rise times.

Eligibility Criteria:
Inclusion Criteria:

* ARDS (Acute Respiratory Distress Syndrome) patients.
* Patients who are deeply sedated.
* Patients ventilated in:
* Pressure-Controlled Ventilation (PCV or PRVC) mode, or
* Volume-Controlled Ventilation (VCV) mode.
* Patients within the 24-48 hour period of their stay in the intensive care unit.

Exclusion Criteria:

* Patients with incomplete data.
* Patients diagnosed with:
* COPD (Chronic Obstructive Pulmonary Disease),
* Heart failure.
* Pregnant patients.
* Patients with a thoracopleural fistula.
* Hemodynamically unstable patients.
Photodynamic Therapy Compared to Adapalene 0.1% Gel Plus Doxycycline in the Treatment of Acne Vulgaris

* Acne vulgaris is a common inflammatory skin disease that affects more than 85% of teens and some people may continue throughout adulthood.
* Topical retinoids related to oral antibiotics are considered first-line treatment of moderate inflammatory acne.
* Recently, photodynamic therapy (PDT) with a photosensitizer, 5-aminolevulinic acid (ALA) or methyl aminolevulinate (MAL), has proven useful in the management of inflammatory acne. Although progress has been made in the study of photodynamic therapy for acne, to date, no study has compared PDT with standard and well-validated pharmaceutical treatments and with the current recommended therapy for most types of acne combination therapy with a topical retinoid plus one or more antimicrobial agents.

Hypothesis

* PDT with the photosensitizer ALA will be effective and safe for the treatment of moderate facial inflammatory acne.
* The ALA-PDT is more effective than conventional therapy with oral antibiotics and topical retinoids in the treatment of moderate inflammatory acne with faster action at 12 weeks of follow-up.

* There will be a randomized, controlled, single blind comparison study of PDT with 5-aminolevulinic acid (ALA) 20% versus conventional therapy consisting of topical 0.1% adapalene plus doxycycline 100 mg/day orally in patients with moderate inflammatory acne.
* Be sought from all patients written informed consent prior to study entry.
* For sample size calculation, we assumed that the correlation is the same in both groups and is relatively low (0.01), the number of lesions per subject is equal in both groups with a mean of 100 and low variance, which take 1 control per case and that. Whereas the percentage of improvement in the control group is 0.6 and expected in the treatment group is 0.7 yields a sample size of 23 patients in the treatment group and 23 new controls.

Interventions:

Patients will be randomized to receive:

1. ALA-PDT: In 23 patients applied 20% ALA solution in the affected area for 1.5 hours. Subsequently irradiated with noncoherent red light (lamp Waldmann PDT 1200; wavelength 590-700 nm) with irradiance of 70 mW/cm2 and total dose or fluence of 37 J/cm2 for 7-9 minutes. From the sixth week will begin nightly topical adapalene 0.1% gel.
2. Standard therapy:

In 23 patients applied topical adapalene 0.1% gel at night for 12 weeks plus doxycycline 100 mg / day for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Men and women between 18 and 30 years of age with moderate inflammatory acne

Exclusion Criteria:

* Those who have received any treatment for acne either topic in the last 3 months before and systemic (including ACO started) in the last 6 months of the study.
* Patients who are pregnant or breastfeeding.
* Patients with history of photosensitivity or autoimmune disease.
* Patients with a history or active TB disease or HIV.
* Patient refusal to participate in the study.
Effect of Neuromuscular Blockade on Pulmonary Complications in Elective Cardiac Surgery

The investigators will conduct a prospective, randomized trial to assess the impact of neuromuscular blockade on early (\<72 hours post-ICU admission) postoperative respiratory complications in cardiac surgical patients. The study will compare continual neuromuscular blockade with cisatracurium to a single dose of succinylcholine during general anesthesia for cardiac surgery.

Residual neuromuscular blockade during the immediate postoperative period is an important patient safety issue. Although used to facilitate the technical performance of surgery, clinical studies have associated neuromuscular blockade (NMB) with increased incidence of postoperative respiratory complications. This effect is likely mediated by residual neuromuscular blockade interfering with airway tone and respiratory effort, leading to postoperative pneumonia, atelectasis or aspiration. However, the vast majority of these studies have involved non-cardiac patient populations, yet patients undergoing cardiac surgery are even more susceptible to the detrimental effects of residual neuromuscular blockade for a number of reasons. Despite widespread utilization of paralysis during cardiac surgery, very little is known about residual neuromuscular blockade in patients following cardiac surgery. Previously published clinical studies date from over a decade ago or are based on retrospective databases from non-cardiac surgery patients, precluding generalizable conclusions. Given the substantial role of neuromuscular blockade in the traditional management of cardiac surgical patients, prospective data is needed to determine the veracity of this association as well as the surgical tolerability of protocols that minimize intraoperative paralysis. The investigators will conduct a prospective, randomized trial to assess impact of neuromuscular blockade on early (\<72 hours post-ICU admission) postoperative respiratory complications.

Eligibility Criteria:
Inclusion Criteria:

* Elective cardiac surgery (CABG, valve replacement, CABG + valve) requiring cardiopulmonary bypass

Exclusion Criteria:

* Emergency surgery
* Extremes of age
* Previous cardiac surgery
* Clinical contraindications to succinylcholine or cisatracurium
* Anticipated difficult tracheal intubation
* Preoperative mechanical ventilation
* Preoperative pharmacologic/mechanical hemodynamic support
Metronomic Cyclophosphamide in Combination With Standard Chemotherapy for Squamous Cell Lung Carcinoma

Treatment of locally advanced and metastatic squamous cell carcinoma of the lung involves the use of chemotherapy as the therapeutic mainstay. Platinum-etoposide regimens (such as cisplatin-etoposide) are the most commonly used chemotherapeutic regimen, which is delivered intravenously in the standard three-weekly intervals.

Recent interest in oral metronomic chemotherapy has arisen, especially due to its beneficial effects in delaying disease progression among heavily pre-treated patients with various malignancies.

This study attempts to combine the use of metronomic chemotherapy concurrently during standard intravenous chemotherapy.

Adenocarinoma and squamous cell carinoma are the two major types of non-small cell lung carcinoma. While patients with adenocarcinoma of the lung have the feasibility of treatment with tyrosine kinase inhibitors, the patients with squamous cell carcinoma can only be treated with standard chemotherapy due to the ineffectiveness of tyrosine kinase inhibitors. Thus, the current standard is to treat patients of squamous cell lung cancers with standard intravenous chemotherapy, which is mostly delivered once in three weeks.

Metronomic chemotherapy, meaning the delivery of low doses of chemotherapy, often by an oral approach, on a daily basis so as to maintain a low but definite level of the chemotherapy has received great interest in recent times due to its beneficial effects in terms of extending progression free survival among patients of various malignancies, even after failure with previous conventional therapies. Metronomic chemotherapy is proposed to be active by alternate mechanisms, such as the predominant anti-angiogenic effect, in contrast to the cytotoxic and genotoxic effects of standard chemotherapy.

Metronomic chemotherapy with oral cyclophosphamide has been shown to extend progression free survival when used as a single agent in various malignancies. Given the fact that progression after varying time spans is a rule (rather than the exception) among patients of squamous cell lung cancer being treated with conventional chemotherapy, we have intended to combine the use of oral metronomic chemotherapy given concurrently with standard intravenous cisplatin-etoposide based chemotherapy. We intend to observe a prolongation of progression free survival.

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically proven squamous cell carcinoma of the lung
* Surgically unresectable or metastatic disease

Exclusion Criteria:

* Severe life limiting diabetes, hypertension or cardiac co-morbidities
* Co-existing tuberculosis
* Brain metastases at presentation
* Non-consenting patients
* Previously treated with any regimen of chemotherapy for existing or previous malignancy