cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial of Favipiravir Tablets Combine With Chloroquine Phosphate in the Treatment of Novel Coronavirus Pneumonia

This study is a multi-centered, three-armed, randomized, double-blinded, controlled study, namely, the oral trial drug favipiravir tablets plus chloroquine phosphatetablets tablets group (combined group), the oral trial drug favipiravir tablets group (pirovir group), and the oral placebo treatment group (control group). The total number of enrolled cases in this study was set at 150.

During the treatment, the clinical data of the subjects were collected, the changes of viral load and biochemical indicators were detected, and the outcome of the subjects was monitored.

The main indicators of efficacy include improvement or recovery of respiratory symptoms and viral nucleic acid shedding. The rate of progression to severe disease, duration of fever, peripheral blood index and improvement time of pulmonary imaging were the secondary indicators to evaluate the efficacy.

Statistical analysis was performed at the middle and final stages of the study to evaluate the efficacy and safety of favipiravir tablets combined with chloroquine phosphatetablets tablets in the treatment of novel coronavirus pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Male and female, 18-75 years old
* Patients previously diagnosed with novel coronavirus pneumonia: the course of illness is no more than 14 days; if the course of the disease was more than 14 days, patient meets one of the following conditions can also be included in the group: (1) No apparent absorption or progression of chest radiograph was observed within 7 days; (2) respiratory symptoms (chest tightness, or cough, or breathing difficulties); (3) Test for viral nucleic acid positive within 3 days.
* informed consent should be signed by the participate or an authorized agent
* Agree to clinical samples collection
* Female or male subjects of childbearing age agree to take effective contraceptive measures within 3 months of the last oral medication to ensure that female or male partners of childbearing age do not become pregnant

Exclusion Criteria:

* Severe vomiting or difficulty ingesting medication
* Woman who are pregnant or during lactation
* Patients received lopinavir/ridonavir, ribavirin, interferon and monoclonal antibody specific antiviral drugs three days before enrollment
* Cases of respiratory failure requiring mechanical ventilation
* Shock
* Combined with other organ failure and requires ICU care
* Clinical prognostic non-survival, palliative care, or in deep coma and no have response to supportive treatment within three hours of admission
Effect of CYP3A Genetic Polymorphisms on the Pharmacokinetics of Atorvastatin

The aim of the study is to investigate the effects of CYP3A polymorphisms on the pharmacokinetics of Atorvastatin in Chinese subjects with coronary heart disease.

Large variability exists in the individual response to statins. CYP3A polymorphisms likely contribute to variable response to those drugs primarily metabolized by CYP3A including atorvastatin.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
* Subjects must be \>=35 years and \<=70 years of age.
* Subjects must have an LDL-C concentration \>=2.6 mmol/L and TC concentration \>=4.14 mmol/L
* Body mass index (BMI) must be within the range of 19 to 30 for patients.
* Subjects must have documented coronary heart disease with one or more of the following features:

  * Documented stable angina (with evidence of ischemia on exercise testing)
  * History of myocardial infarction
  * History of percutaneous coronary intervention (with or without stent placement)
  * Documented history of unstable angina or non-Q wave myocardial infarction.

Exclusion Criteria:

* Diabetes and endocrine or metabolic disease.
* Congestive heart failure defined by New York Heart Association (NYHA) as Class III or IV.
* Uncontrolled cardiac arrhythmia.
* Uncontrolled hypertension (Systolic BP \>160 mm Hg and/or Diastolic BP \>100 mmHg on two consecutive measurements).
* Liver or kidney disease confirmed by abnormal lab values or function.
* Smokers who report cigarette use of more then 10 cigarette per day.
* Subjects who consume \>2 alcoholic drinks a day. (A drink is: a can of beer, glass of wine, or single measure of spirits).
* Known human immunodeficiency virus (HIV) positive.
* Cancer.
* Subjects who are on any of the following concomitant medications:

  * Medications that are potent inhibitors of CYP3A, including cyclosporine, itraconazole, fluconazole, and ketoconazole, erythromycin or clarithromycin, nefazodone, protease inhibitors,mibefradil and large amounts of grapefruit juice (\>1 quart/day).
  * Lipid-lowering agent: niacin (\>200 mg/day) taken within 5 weeks, fibric acid derivatives taken within 8 weeks.
Critically Ill Patient's Capacity

How to determine the decision-making capacity of critically-ill patients remain unclear. The investigator study the differences between standardised evaluation and subjective medical evaluation.

After written information and consent, an independent, specially trained investigator interviews patients with a standardised test.

After written information and consent, an independent, specially trained investigator interviews residents, doctors and nurses in charge of the patient and ask them how they rates patients capacity.

Eligibility Criteria:
Inclusion Criteria:

* Caregivers :

Doctors, hospital interns, nurses state of both sexes, aged 18 years or more working in Intensive Care, members of a social security system engaged in a clinic on the day of the assessment

* Patients :

Patients of both sexes, aged 18 years or more hospitalized in Intensive Care, members of a social security system

Exclusion Criteria:

-
Dexamethasone for Pain After Shoulder Surgery

The purpose of this study is to determine if a dose of 40 mg dexamethasone is more effective as pain treatment than the currently used dose of 8 mg after arthroscopic shoulder surgery.


Eligibility Criteria:
Inclusion Criteria:

* Arthroscopic subacromial decompression and/or acromioclavicular resection
* General anaesthesia
* Daysurgery, Horsens Hospital

Exclusion Criteria:

* Incompetent
* Pregnant
* Age under 18 or over 90 years
* Allergy toward dexamethasone
* Diabetes
* Active gastric ulcer
* Untreated hypertension
* Glaucoma
* Daily use of glucocorticoids or strong opioids
* Daily use of analgesics for unrelated illness
* Myasthenia gravis
* Mitochondrial disorders
The Use of CO2 in Routine-Colonoscopy

In this double-blind, randomised and controlled study 150 Patients referred to colonoscopy were assigned to either CO2 or air insufflation. We recorded basic characteristics of colonoscopy and the amount of drugs used for sedation. Patients and investigators filled out questionnaires to record pain, abdominal bloating and flatulence.

Between April 2012 and August 2014 150 patients referred to the University Hospital of Leipzig for colonoscopy were randomly assigned to either CO2 or air insufflation.

All examinations were performed by one of four experienced endoscopists. The patients usually received sedation. For sedation midazolam and propofol was used. At the beginning of the examination the patients usually received between 3-5 mg of midazolam and 20-40 mg propofol. During endoscopy propofol was titrated by administration of 20 mg at the time according to and pain reaction of the patient and required depth of sedation.

All patients had nasal insufflation of oxygen with 2 litres per minute. All sedated patients were monitored for pulse, blood pressure and blood oxygen saturation.

For bowel cleansing a solution of Macrogol 3350 (Moviprep®, Norgine) was administered orally according to the manufacturer.

All colonoscopies were performed using Fujifilm Endoscopes (EC 590 Series). For examinations with use of carbon dioxide the Fujifilm CO2 Insufflator GW-1 was used with appropriate water bottle and endoscope valve. The air pump of the light source Fujifilm System 4400 was deactivated according to the manufacturer.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* informed consent

Exclusion Criteria:

* former colonic resections
* severe heart or lung disease (NYHA III or IV)
* Pregnancy
* Patients with planned gastroscopy within 24 hours
Reandron in Diabetic Men Witn Low Testosterone Level

In men with type 2 diabetes, low testosterone levels have been associated with insulin resistance, truncal obesity and symptoms such as fatigue and erectile dysfunction. Low testosterone may impair cardiac function and increase cardiovascular risk and cause osteoporosis. The goal of this project is to assess prospectively whether, in men with type 2 diabetes mellitus and low testosterone levels, testosterone replacement improves insulin resistance, body composition, bone density, cardiac function symptoms associated with low testosterone level.

The investigators will recruit 140 ambulatory men with type 2 diabetes and a low serum testosterone level (\<10 nmol/L) from Austin Health Endocrine clinics, General Practise surgeries, and from the general public by direct consumer advertising via newspaper and other local media. Men will be randomised to either intramuscular testosterone undecanoate (Reandron 1000, Bayer Schering Pharma) or placebo. Men with contraindications to testosterone replacement or to intramuscular injections will be excluded from the study. All men will receive intramuscular testosterone or placebo injections at 0, 6, 18 and 30 weeks (a total of four injections).

All 140 study subjects will have a clinical and laboratory assessment at baseline, 18 weeks and at study end (40 weeks). All 140 subjects will also have imaging studies at baseline and at study end (40 weeks). The study protocol is outlined in more detail below:

Clinical and laboratory assessment (Baseline and repeated 18 weeks, 40 weeks) A full medical history and physical examination will be performed. Symptoms will be assessed by the following standardised questionnaires: 1) Androgen Deficiency in the Aging Male (ADAM); 2) Aging Male Symptom scale (AMS); 3) International Index of Erectile Dysfunction (IIED); 4) International Prostate Symptom Score (IPSS); 5) SF-36 (all five questionnaires are attached to Module 1).

Laboratory studies will consist of blood tests to measure total testosterone, fasting glucose, C-peptide, HBA1c and other routine parameters.

Imaging studies (Baseline and repeated at 40 weeks)

1. Body composition and bone mineral density by DEXA
2. Body composition by magnetic resonance imaging
3. Bony micro-architecture by high resolution quantitative computed tomography \[HR-pQCT\]),
4. Cardiac dimensions and function by transthoracic doppler echocardiography


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Testosterone less than 10 nmol/L

Exclusion Criteria:

* Contraindication to
* Testosterone or
* IM injection
Comparison of Virtual Training to In-Person Training of Helping Babies Breathe in Ethiopia

Helping Babies Breathe (HBB) is a program that teaches providers in low- and middle-income countries about neonatal resuscitation. Historically, HBB training was delivered in person. During the COVID-19 pandemic, many subject matter experts were unable to travel to conduct HBB courses. Innovative methods for teaching HBB are needed to promote the acquisition and retention of resuscitation skills and knowledge.

In this non-inferiority randomized controlled trial, medical students, nursing students, and midwifery students will be randomized to receive either standard in-person HBB training (control) or virtual telesimulation training (intervention). The hypothesis is that virtual delivery is as effective as in-person training of HBB content when teaching neonatal resuscitation skills and knowledge to medical, nursing, and midwifery students.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Year IV through year VI medical students, year II to IV nursing students, year II and III midwifery students at Jimma University in Jimma, Ethiopia.

Exclusion Criteria:

* Minors
* Individuals who are not medical students, nursing students, or midwifery students at Jimma University.
* Individuals who attended a neonatal resuscitation training course in the preceding year.
* Individuals who would be unavailable or unwilling to participate in follow-up study activities throughout the 2-month post-initial training period.
Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade

To assess persistence of CT-P13 in patients with Rheumatoid Diseases (Rheumatoid arthritis \[RA\], ankylosing spondylitis \[AS\], and psoriatic arthritis \[PsA\]) who are naïve to biologics or are switching from stable Remicade to CT-P13. The main objectives of the study are:

* To evaluate real-life drug persistence in RA, AS, and PsA patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade
* To characterise the patient populations and drug usage patterns of RA, AS, and PsA patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade
* To assess the safety of CT-P13 in RA, AS, and PsA patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade for up to 2 years

The study will be conducted in accordance with legal and regulatory requirements with scientific purpose, value and rigor following generally accepted research practices described in Guidelines for Good Pharmacoepidemiology Practices (GPP), Good Epidemiological Practice (GEP), Good Practices for Outcomes Research, International Ethical Guidelines for Epidemiological Research, European Medicines Agency (EMA) European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology, and FDA Guidance for Industry. Data sources will be validated and will consist of the hospital medical records and monitoring will be organized on a regular basis. Data sources will be validated. The source data will consist of medical records, physician questionnaires, and patient questionnaires. Data for the study will be entered into an electronic data capture system. Questionnaires will be completed on electronic tablets. The study is a one year enrollment period with a two year follow-up period. The study plans to enroll patients throughout Canada and Europe.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥18 years old at the time of enrollment
2. Patients who are prescribed CT-P13 or Remicade for the treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis prescribed according to the corresponding summary of product characteristics (SmPC and Product Monograph) as determined by the investigator

Exclusion Criteria:

1. Any reported contraindications for Inflectra according to the SmPC or Product Monograph
2. Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrollment
Research on the Application of Blood Collection Through Midline Catheters of Different Lengths

Therefore, in this study, the investigators propose to use a randomized controlled prospective open study on inpatients with difficult blood collection, by comparing the effects of the application of two types of peripheral venous catheters for blood collection via LPC and MC, with a view to improving the success rate of blood collection in difficult peripheral venous blood collection, and providing a theoretical basis for the later application of long peripheral venous catheters and midline catheters; and providing a basis for optimizing the experience of venous blood collection by nurses.

Using block randomization, patients were randomized in 1:1:1 blocks into experimental arm 1(Long peripheral venous catheter), experimental arm 2(midline catheter), and control (short peripheral venous catheter) with a block length of 6. Patients have a total of 27 blocks, import data into SPSS23, randomly group by SPSS, generate random numbers, and group according to the size of random numbers in each unit group, the largest in the group is assigned to the experimental group 1, the middle of the group is assigned to the experimental group 2, and the smallest in the group is assigned to the control group. The experimental group1 used the LPC for blood collection, the experimental group 2 used the MC for blood collection,and the control group used the Short PIVC for blood collection.

Eligibility Criteria:
Inclusion Criteria:

* Meet the international diagnostic criteria for metabolic syndrome (such as ATP III criteria or domestic Diabetes Branch of Chinese Medical Association criteria).
* The estimated treatment time of intravenous infusion is 1-4 weeks, and the nature of the infusion drug meets the indications of LPCs and MCs.
* Blood samples should be collected more than 3 times during the hospital.

Exclusion Criteria:

* A history of radiotherapy, thrombosis, and trauma at the catheter site.
* Plan to discharge from the hospital with the tube.
* Vulnerable groups, including people with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, illiterate, etc.
Ovarian Hyperstimulation and Fibrin Clot Properties.

The impact evaluation of ovarian hyperstimulation on coagulation and fibrinolysis in infertile women.

Comparative analysis between different ovarian stimulation protocols on thrombin formation and efficiency of fibrinolysis in women diagnosed with infertility.

Infertility is a common problem. Assisted reproductive techniques (ART) increases the chance of getting pregnant by couples undergoing such treatment. Unfortunately, the numer of live births after ART remains still low. Over the past three decades, physicians have tried to improve infertility diagnosis and increase its successful treatment. An effort aimed at increasing effectivenes of diagnosis resulted in hypothesis that one of probable reasons of infertility may be the occurrence of microclots, which worsen implantation and embryos development. There are currently no published studies describing the effects of different ovarian hyperstimulation protocols on hemostasis (coagulation and fibrinolysis).

The parameters of thrombin generation and efficiency of fibrinolysis will be evaluated in women qualified for ovarian hyperstimulation. The study may improve the effectiveness of ART.

Eligibility Criteria:
Inclusion Criteria:

* infertility defined based on the WHO 2010 criteria

Exclusion Criteria:

* ovarian involvement
* oral contraceptives use within previous 3 months
* dienogest therapy within 3 months until ART
* thrombotic events in the medical history
* severe hypertension
* diabetes mellitus
* the presence of known VTE risk factors, including obesity, recent major surgery with prolonged immobilization or trauma,
* deficiency of antithrombin, protein C or protein S,
* antiphospholipid syndrome,
* known malignancy,
* any chronic inflammatory diseases (e.g. rheumatoid arthritis)
* advanced chronic renal disease (estimated glomerular filtration rate \[eGFR\] \<30 ml/min),
* international normalized ratio (INR) more than 1.2 at the day of blood draw
* pregnancy.
Turkish Validity and Reliability of Pain Catastrophizing Scale-Child (PCS-C)

Perception of chronic pain and related disability; occurs through the interaction of physiological and psychological processes. Pain catastrophizing is a cognitive attribution style characterized by a negative mindset and magnification of pain. Catastrophizing in children has been associated with poor functioning and higher levels of pain. Catastrophizing during the transition to adulthood is defined as an important predictor of persistent pain and central sensitivity. The number of scales assessing pain and attitudes related to pain in children is quite low. In recent years, with the adaptation of the assessment scales used for adults to children or the development of new scales, the assessment of pain and pain-related attitudes in children has begun to be provided. Pain catastrophizing scale (PCS), in 1995 Sullivan et al. for the purpose of comprehensive assessment in adults experiencing pain-related disasters. In 2003, Crombez et al. showed the validity and reliability of the scale in school-age children. For predictive validity, the scale was administered to children with chronic pain, and it was reported to predict the severity of pain and pain-related disability.

Pain Catastrophizing Scale-Child (PCS-C) scale; It is a self-report measure adapted from the Adult Pain Catastrophizing Scale used to assess negative thinking associated with pain. It contains 13 items rated on a 5-point scale ranging from 0 = "not at all true" to 4 = "very true". Substances; rumination (4 items, e.g. "When \[my child\] has pain, I can't get him out of my mind"), magnification (3 items, e.g. the child has pain\], thinking about other painful events"), and helplessness (6 items, e.g. "\[My child's\]\] When I have pain, I feel that I cannot continue"). Items are aggregated across subscales to obtain a total score ranging from 0 to 52; higher scores are related to higher catastrophizing attitude.

The pain catastrophizing scale was originally developed in German and later validity and reliability studies were conducted in different languages. The aim of this study is to question the Turkish validity and reliability of the "Pain Catastrophizing Scale-Child (PCS-C)" scale.

Now, the study is continuing. 50% of the participant were evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. 7-18 years old
2. Agree to participate in the study
3. Whose symptoms and medications are stable,
4. Do not have a psychiatric disease that may affect cooperation,
5. Patients with JIA who do not have heart failure and lung pathology at a level that will affect their daily living activities will be included.

Exclusion Criteria:

Participants who cannot understand and follow the instructions will be excluded from the study