cyrilzakka/clinical-trials huggingface dataset:
Mouth-to-mouth Ventilation Efficiency Through Breathable Self-sterilizing Respirator During BLS in COVID-19 Pandemic

Complex practical BLS training have been stopped all over the world due to COVID-19 pandemic in 2020. While launching the new Simulation Centre at Medical Faculty of Masaryk University in Brno, Czech Republic, teachers and students have been dealing with the risk of COVID-19 transmission during the simulation training. One of the highest risks for the transfer of COVID-19 between the medical students is during the mouth-to-mouth ventilation training in BLS.

It has been assumed that rescuers during BLS simulation training with use of breathable nanofiber respirator with layers with accelerated copper can provide efficient mouth-to-mouth rescue breaths to the mannequin in compliance with safety rules.

The main aim of this study is to assess the efficiency of mouth-to-mouth ventilation through breathable self-sterilizing nanofiber respirators with accelerated copper in COVID-19 pandemic time. 100 volunteers (medical students trained as BLS trainers an medical students trained in BLS) will provide 2 minutes cycle of BLS according to European Resuscitation Council (ERC) guidelines 2021 wearing the breathable self-sterilizing nanofiber respirators with accelerated copper in three different mannequins: Professional Adult Medium Skin CPR-AED Training Manikin with CPR Monitor (Prestan), Resusci Anne QCPR AED (Laerdal), Resusci Baby QCPR (Laerdal). The mannequin will be utilised in a randomised order. The efficiency of mouth-to-mouth rescue breaths as "visible breath " and "not visible breath" will be recorded. In first BLS mannequin, the visibility of chest rising by the observer will be recorded. In two other mannequins, the ventilation metrics and each rescue breath evaluation in QCPR Skill Reporter will be recorded. Overall, 3 levels of visible breath according to the relation to set optimal breath volume (400 to 600 mL in adult, 30 to 50 mL in infant): low volume breath (below 400ml in adults and below 30ml in infant), optimal volume breath (between 400-600ml in adult and between 30-50 ml in infant), high volume breath (over 600ml in adult and over 50ml in infant) will be evaluated. For the primary analysis of efficiency of mouth-to-mouth ventilation, data from all three mannequins using outcome No breath / Visible breath will be evaluated. Secondary analysis will utilize data from two mannequins where detailed stratification No Breath / low / optimal / high Visible breath is possible. The mean volume of rescue breaths in the 2-minute cycle, average pause, longest pause, success in achieving the optimal breath volume, adverse events will be recorded. Regarding the technique of provided mouth-to-mouth ventilation, head tilt in adult or neutral position in infant and pinching of the nose will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* medical students trained in BLS as BLS trainers
* medical students trained in BLS

Exclusion Criteria:

* refusing to participate
* non-medical students
The Effects of Video Modeling of Audiological Testing on Pediatric Patient Compliance

The purpose of the current study is to determine if pre-exposure through video modeling will enhance testing compliance in a population of children who are receiving a diagnostic evaluation for Autism.

The purpose of the current study is to determine if pre-exposure through video modeling will enhance testing compliance in a population of children who are receiving a diagnostic evaluation for Autism. Another purpose of this study is to determine if pre-exposure to the test setting can increase the compliance on individual test measures. To test the central hypothesis and accomplish the study objective, 2 aims guide the proposed study.

1. Determine the extent to which pre-exposure to expectations and tasks that occur during the audiological evaluation will increase audiological testing compliance. Hypothesis: Children receiving the intervention video, which will model what they will experience during the audiological evaluation, will show greater compliance during the evaluation than children who receive the placebo video.
2. Determine the extent to which enhanced testing compliance will increase the number of test measures obtained during an audiological evaluation. Hypothesis: Children who are more compliant during the audiological evaluation will allow the audiologist to obtain more test measures in a single appointment than the children who are less compliant.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* Child must have chronological age of less than 36 months
* Participation in the Northwestern University Center for Audiology, Speech, Language, and Learning (NUCASLL) Developmental Diagnostic Program (DDP)
* A parent or caregiver who is willing to watch the intervention video, bring the child to/ participate in the audiological evaluation, and fill out a brief survey prior to and following the appointment, and
* Parent must understand English and speak English to their child.

Exclusion Criteria:

* None
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) in the Treatment of Major Depressive Disorder

The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of DVS SR (25 and 50 mg/day) in the treatment of adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive symptoms for at least 30 days prior to screening)
* Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of \>= 20
* Clinical Global Impressions Scale-Severity (CGI-S) score of \>= 4

Exclusion Criteria:

* Clinical instability - 25% or greater increase/decrease in HAM-D 17 total score from screening to baseline
* Significant risk of suicide as assessed by clinician judgement, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply
Evaluating the Topical Herbal Solution on the Treatment of Male Pattern Hair Loss and Comparison With Minoxidil 5%

The purpose of this study is evaluating the efficacy and safety of a topical herbal solution in males for the treatment of Androgenetic alopecia.

This study will be done on male subjects with Androgenetic alopecia(AGA). The patients will be selected by volunteers attending the Dermatology department of Sina Hospital, and eligible individuals will be selected among them. Subjects were randomized to use either Topical Herbal Solution or Topical Minoxidil 5% for 36 weeks.

To our knowledge, this herbal solution for the first time covers all four major causes of AGA, including the 5α-reductase enzyme, androgen receptors, paracrine agents that affecting dermal papilla and hair cell apoptosis processes. Therefore it acts with the quadruple mechanism. The application of this new herbal solution for the treatment of AGA should be recommended.

Eligibility Criteria:
Inclusion Criteria:

* Men 18 to 50 years old
* Written consent
* Normal general health status
* Men who have a presentation of androgenetic alopecia (Norwood II - V).

Exclusion Criteria:

* Use of any topical product in the target region interfering with the study product in the last three months
* Within the past 6 months receiving of chemotherapy/cytotoxic agents
* Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia
* Uncontrolled hypertension
* Any dermatological disorders in the scalp, such as fungal or bacterial infections, eczema, atopic dermatitis, seborrheic dermatitis, psoriasis, sun damage, skin cancer
* Hormonal diseases such as thyroid disorders, diabetes and, ...
* Smokers
* Liver and kidney disease
* History of hair transplants
* History of surgical correction of hair loss on the scalp
* Subject having dyed, bleached hair or, with a permanent wave prior to study start.
* No written consent
A Study in Parkinson's Disease in Patients With Moderate to Severe Dyskinesia

The current study will explore the efficacy, safety and tolerability of 2 dose combinations of JM-010 to determine the optimal doses of each component to be studied in confirmatory clinical trials.

This is a Phase 2, double-blind, double-dummy, placebo-controlled, randomized, parallel group, multicentre study.

Subjects with a diagnosis of moderate to severe dyskinesia in Parkinson's disease (PD) will complete a Screening Visit to assess eligibility to participate in the study.

Subjects will continue with their usual levodopa treatment regimen for the duration of study participation.

The screening assessment period will be a minimum of 1 week up to a maximum of 6 weeks. Subjects deemed to be eligible at the end of the Screening Visit will be randomly assigned in a 1:1:1 ratio to receive either 1 of the 2 dose combinations of JM-010 and 1 placebo, or 2 placebos as per the double-dummy study design. The randomized subjects will be followed treatment periods for 12 weeks and safety follow periods for 2 weeks, including pharmacokinetic (PK) sub-study.

Eligibility Criteria:
Inclusion Criteria:

* Is able to read, understand, and provide written, dated informed consent prior to Screening Visit.
* Is male or female, between 18 and 80 years of age at Screening Visit.
* Is diagnosed with idiopathic PD that meets UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria and requires treatment with and shows responsiveness to levodopa.
* Has experienced dyskinesia over a period of at least 3 months prior to Screening Visit
* Has stable peak-effect dyskinesia
* Has more than one hour of "ON" time with troublesome dyskinesia during daily waking hours on a 24-hour PD subject diary
* Is on a stable levodopa dosing regimen requiring at least 3 dose administrations but no more than 6 dose administrations per day

Exclusion Criteria:

* Has undergone surgery for the treatment of PD
* Has a current diagnosis of Substance Use (including alcohol) Disorder (Abuse or Dependence, as defined by Diagnostic and Statistical Manual, Fifth Edition \[DSM 5\]),
* Has psychiatric diagnosis of acute psychotic disorder or other psychiatric diagnoses
* Has a significant risk for suicidal behaviour in the opinion of the investigator during the course of their participation in the study
* Has current seizure disorders (other than febrile seizures in childhood) requiring treatment with anticonvulsants.
* Has known serious ongoing symptomatic cerebral disease or cerebrovascular disease or any acute brain trauma requiring treatment with anti-convulsant therapy within 5 years prior Visit 2, Week 0 (Baseline Visit).
* Has a history of exclusively diphasic, OFF state, myoclonic, dystonic, or akathetic dyskinesia without peak-dose dyskinesia.

Other criteria related to other medical conditions to be referred to the protocol.
Supramaximal Rectus Recession for Strabismus in Grave's Ophthalmopathy

The purpose of this study is to evaluate supramaximal rectus recession for strabismus in Grave's Ophthalmopathy

To evaluate the effectiveness and complications of supramaximal rectus recession for large-angle strabismus in Grave's Ophthalmopathy

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Grave's ophthalmopathy
* angle of deviation more than 20°
* clinically and biochemically euthyroid for at least 3 months;
* a stable orthoptic examination for at least 3 months, for example no greater than five prism dioptre change in primary position and no greater than an 8° change in duction
* monocular and mainly single extraocular muscle restricted motility

Exclusion Criteria:

* Patients with suppression, previously diagnosed and/or treated strabismus not related to the thyroid
* best-corrected visual acuity (BCVA) less than 0.2 in one or both eyes
Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome

The survey is conducted to investigate the safety and efficacy of long-term use of BI-Sifrol Tablets in Restless Legs Syndrome (RLS) patients with or without renal dysfunction in routine medical practice.


Eligibility Criteria:
Inclusion criteria:

Patient with Restless Legs Syndrome

Exclusion criteria:

None
Comparison of Quality of Life Between Patients Underwent Transoral Endoscopic Thyroid Surgery and Conventional Surgery

The purpose of this study is to determine the quality of life of transoral endoscopic thyroidectomy compare with open thyroidectomy, Furthermore, postoperative complication will be assessed, also.

Regarding type of surgery, doctor will just advice about risk and benefit of any type of surgery. And then patient will select by himself. Patients are not assigned to endoscopic or conventional group.

This study start to enrolled patients after surgery. And the quality of life will be observed at 2, 6 and 12 weeks, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Patient who underwent thyroid lobectomy for benign thyroid nodule less or equal 5 cm

Exclusion Criteria:

* previous neck surgery
* suspected thyroid carcinoma
* patient who failure endoscopic thyroidectomy and change to conventional surgery
Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies.

It is hypothesized that repository corticotropin injection in combination with other biologic agents will be able to provide relief of both rheumatoid arthritis and acute exacerbations of rheumatoid arthritis for patients with disease that had inadequately responded to biologics previously.

Although there are many types of treatment for rheumatoid arthritis (RA) currently available, some patients have disease that is refractory to treatment and cannot achieve remission. The objective of this study is to assess the efficacy and safety of subcutaneous injections of repository corticotropin as an adjunct therapy in patients with active RA who have had an inadequate response to at least two biologic agents as well as a third agent they are currently receiving.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis of at least 2 years duration
* On at least third biologic with a different mechanism of action for at least 12 weeks
* Active disease as defined by at least 6 tender and 6 swollen joints
* Erythrocyte sedimentation rate (ESR) at least 28 mm/hr or C-reactive protein (CRP) at least 1.2 times the upper limit of normal
* Stable dose of disease modifying anti-rheumatic drug (DMARD) and prednisone for at least 4 weeks

Exclusion Criteria:

* Prior treatment with Acthar Gel
* History of intolerance or allergy to glucocorticoids
* Unstable diabetes
* Active infection
Mass Balance Study of [14C]HLX208 in China Healthy Subjects

Mass Balance Study of \[14C\]HLX208 in China Healthy Subjects.

A phase I study to quantify the total mass balance in healthy subjects after a single dose of \[14C\]HLX208.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects between the ages of 18 and 45 years (inclusive).
2. Subjects weighing ≥ 50 kg and Body Mass Index of 18.0 to 32.0 kg/m2.
3. No sperm donation or fertility plan during the study and within 12 months after the end of the study.
4. Subjects who have voluntarily participated in the study and signed the informed consent form with good compliance.

Exclusion Criteria:

1. Known history of drug or food allergy.
2. Known medical history judged by the investigator as not suitable for the study.
3. Has laboratory or physical examination abnormalities during the screening period.
4. Has a positive test for, HBV，HCV，HIV，or syphilis.
5. Has drug abuse history or positive drug abuse test results.
6. Has diseases affecting the absorption, distribution, metabolism, and excretion of oral drugs.
7. Has any other conditions judged by the investigator as not suitable for the study.
Unstable Angina Pectoris Trial

To compare the efficacy of medical or surgical (coronary artery bypass graft) therapy with regard to survival and quality of life in patients with unstable angina and requisite coronary anatomy as defined by angiography.

BACKGROUND:

Angina pectoris is a symptomatic condition of attacks of chest pain, often debilitating. It is caused by a decreased supply of blood to the heart, such as that which might occur in coronary artery disease. The usual treatment of angina pectoris is designed to relieve the symptoms. It includes avoidance of activities that produce the discomfort and the use of nitroglycerin and beta blocking drugs. Soon after the introduction of coronary bypass surgery, many doctors enthusiastically adopted this approach in treating patients with unstable angina.

In 1972, emphasizing that there was no definitive evidence showing the superiority of intensive medical management or coronary bypass surgery in determining mortality and morbidity in patients hospitalized with unstable angina, some of the participating groups in the NHLBI Myocardial Infarction Research Units developed a cooperative clinical trial to compare these medical and surgical approaches to therapy.

From 1972 through 1976, 288 patients were entered into this randomized clinical trial. One hundred forty-seven patients received intensive pharmacological medical therapy, and 141 comparable patients underwent coronary artery bypass surgery. Careful follow-up studies were performed on patients in both groups, in-hospital and during the post-hospital phase. These studies included, apart from routine physical examinations, resting electrocardiograms, chest x-ray films, and grade exercise tolerance tests at six months and twelve months.

DESIGN NARRATIVE:

Randomized, non-blind, sequential design with a control group and an experimental group. The patients in the experimental group were treated with coronary bypass surgery. Patients in the control group received intensive medical management. Endpoints were mortality and morbidity measures, such as incidence of myocardial infarction and persistence of angina.

Eligibility Criteria:
Men and women, ages 21 to 65. Angina pectoris (class III or class IV) at rest or with minimal exercise.
Antibiotic-resistant Bacterial Infection of Hepatic Patients

the investigators want to identify the microbial profile, antibiotic resistant bacteria in hepatic patients with infections in Liver ICU, and explore risk factors and outcomes in those patients with antibiotic resistant bacteria.

Bacterial infection signifies major clinical challenge in cirrhotic patients where about 35% of these patients acquire hospital-acquired infections compared with 5% of other hospital in-patients without cirrhosis.It is associated with a mortality rate of 38% with a four-fold increase compared to individuals without cirrhosis.

Cirrhotic patients have a high risk for antimicrobial resistance because of chronic use of prescribed antibiotics like quinolones in secondary prophylaxis for spontaneous bacterial peritonitis. In addition, undergoing invasive procedures and recurrent hospital admissions encourage both increased occurrence of antimicrobial resistance and the spread of resistant pathogens in these patients.

Epidemiology, risk factors and clinical outcomes of MDR infections have raised a special attention in cirrhosis. Some studies reported bacterial resistance in about 50% of examined patients and it is associated with treatment failure, septic shock and hospital mortality especially in nosocomial and healthcare related infections

Eligibility Criteria:
Inclusion Criteria:

* Patients with ESLD at Liver ICU. All patients have the diagnostic criteria for liver cirrhosis by clinical, biochemical, and ultrasonography findings. The severity of liver cirrhosis will be assessed according to the Child-Pugh classification and model for end-stage liver disease (MELD) score.
* These patients are diagnosed as having infection at admission or acquire infection during hospitalization.

Exclusion Criteria:

* Age ≤ 18 years
Cytokine in Cerebrospinal Fluid (CSF) From Multiple Sclerosis Patients

Multiple Sclerosis (MS) is an inflammatory disease of the brain leading to disability. Brain MRI is very useful for MS diagnosis but prognostic biomarkers are still needed. New therapies are also expected to improve MS care. Cytokine arrays provide measure of many different inflammation-related molecules that could help understanding the disease. Moreover, individual prognosis could be linked with the level of such molecules in the CSF of MS patients. The investigators will analyze the cytokine profile of MS and control patients CSF to determine a specific profile of MS and look for prognosis implication in a cohort of patients with clinically isolated syndromes (first manifesatation of MS).

Multiple Sclerosis (MS) is an inflammatory disease of the brain leading to disability. Early treatment could allow better prognosis for the patients in the long term by reducing relapses rates and neurological palsy. However, individual prognostic biomarkers are still needed to adapt the treatment to a given patient. CSF is a strategic body fluid to explore in neurological diseases. In MS, it contains an elevated IgG index and/or oligoclonal bands reflecting the intrathecal synthesis of Igs around the brain. The levels of other inflammatory molecules such cytokines and metalloproteases are also known to be elevated in MS (GM-CSF, IL-6, IL-10, MMP-2, MMP9, TIMP-1, TNF-α, RANTES, MCP-1 and MIP-1). These molecules can now be easily measured by protein arrays.The aim of this study is to measure the level of 40 cytokines and 10 MMPs by means of protein arrays in the CSF from clinically definite MS (CDMS) patients, control patients and patients with a clinically isolated syndrome (CIS). The best MS markers will be determined using multiple ROC curves. Markers of rapid conversion to CDMS after a CIS will also be looked for.The best MS candidate biomarkers will be analyzed by ELISA in a new cohort of patients being recruited.

Eligibility Criteria:
Inclusion Criteria:

* Clinically definite Multiple sclerosis patients (at least 2 relapses)
* Patient having presented another neurological episode suggestive of MULTIPLE SCLEROSIS confirmed or not by a neurologist and allowing to establish the diagnosis of MULTIPLE SCLEROSIS according to the criteria of Mc Donald
* Age ≥ 18 years
* Patients informed about the objectives of the study and about its practical realization

Exclusion Criteria:

* Patient having received a treatment by corticoids in 30 days before the lumbar puncture
* Contraindication of the lumbar puncture such as an anticoagulating oral treatment for example
* Pregnancy