cyrilzakka/clinical-trials huggingface dataset:
Mortality Predictors in Coronary Care in Turkey

This study was undertaken to investigate and document the mortality rates and predictors in coronary care unit (CCU) patients in Turkey.

It is designed to be a multicenter, observational, cross-sectional, and descriptive study. It will be conducted in 50 centers in 12 regions of Turkey. The study does not include any interventional or treatment procedures.

At the end of the study, clinicians will have up-to-date information about predictors of mortality in CCU patients.

The MORCOR-TURK study will be conducted as a nationwide registry in 50 tertiary cardiology centers selected from each EuroStat NUTS region in Turkey according to their population sample weight, prioritizing the volume of hospitals in each region. All consecutive patients admitted to the coronary care units (CCU) will be prospectively admitted during a predefined period of 1 month. The study will be conducted by cardiologists in hospitals who regularly treat cardiac patients. Led by the Cardiology Department of Kutahya Evliya Celebi Research and Training Hospital, 50 centers will be included in the study.

There has not been any large-scale epidemiological study on coronary care patients in Turkey recently. Therefore, up-to-date information in this group of patients is lacking. In particular, significant reductions in mortality and morbidity are expected, thanks to improved medical and interventional facilities. In the light of current data, the investigators designed a large-scale study to document mortality rates and predictors in CCU patients.

In this study, the investigators will include consecutive patients admitted to CCU with cardiovascular indications in all participating centers. Patients will be followed and treated by experienced cardiologists and no further experimental intervention will be planned. In the first part of the study, the investigators will record in-hospital mortality rates and try to identify the best predictors. In the second part of the MORCOR-TURK trial which will have a cohort design, the investigators will follow the successfully discharged patients for 1 year. At the end of the follow-up, investigators will assess the risk factors and predictors of cardiovascular events as secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* hospitalized with cardiovascular diseases
* individuals (or relatives for unconscious patients) who gave written informed consent

Exclusion Criteria:

* younger than 18 years of age
* rejecting to sign an informed consent
* hospitalized to CCU by other departments with noncardiac indications
* patients with active severe noncardiac chronic disease (chronic obstructive pulmonary disease, systemic diseases, and malignancy)
* no vital signs despite adequate cardiopulmonary resuscitation during hospitalization
* rejected to stay in CCU and discharged with his/her own request
Evaluation of Novel Noise Reduction Principles in Hearing Instruments

In the study, the speech intelligibility in noise (Outcome) between a novel noise reduction algorithm (Intervention) versus the standard noise reduction (Comparator) will be tested in adults with a N3-N4 hearing loss (Population) using streamed signals via hearing aids.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age for men: 18 years, minimum age for wom-en: 64 years, hearing aid users,
* Written and spoken German,
* Hearing loss range: N3-N4 Hearing loss (sensorineural)
* Healthy outer ear,
* Ability to understand and follow the instruction of the in-vestigator
* Informed consent as documented by signature.

Exclusion Criteria:

* Clinical contraindications 1) hearing loss is not within the fitting range of the hearing aid, 2) acute tinnitus, 3) de-formity of the ear (closed ear canal or absence of pinna), and 4) neural hearing loss i.e., retro-cochlear pathologies such as absent / non-viable auditory nerve
* Pregnant or breastfeeding women
* Age \>85 years
* known hypersensitivity or allergy,
* limited mobility and not able to attend the appointments
Intraocular Pressure With Loteprednol and Dexamethasone

The purpose of this study is to compare intraocular pressure (IOP) changes after pterygium surgery among patients using loteprednol and dexamethasone during the postoperative period.

Surgical management of pterygium is known to initiate an inflammatory process with different levels of intensity. Corticosteroids are anti-inflammatory agents used to reduce the inflammatory process observed after surgical interventions including after pterygium surgery. However, use of topical corticosteroids can induce an elevation in intraocular pressure (IOP) due to a reduction in the facility of aqueous outflow.

Loteprednol etabonate (LE) was designed to maintain the anti-inflammatory efficiency of corticosteroids while lowering the risk of inducing IOP elevation. LE showed less effect on IOP than Prednisolone Acetate. This probably occurs due to lower levels of LE in the aqueous humor.

Some trials compare LE to other corticosteroids or placebo in treatments of the anterior uveitis, allergic conjunctivitis and cataract surgery. To our knowledge, there are no trials studying the effect of LE on IOP after pterygium surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age: eighteen years old or more
* IOP: less than 22mmHg

Exclusion Criteria:

* History of previous ocular surgery
* Use of topical or systemic corticosteroids for up to a month before the surgery
* Extensive pterygia that disabled accurate IOP measurement
Safety and Antidepressant Effects of Rellidep in Major Depressive Disorder

The investigators hypothesize that Rellidep will be effective in improving the symptoms of major depression. The available evidence strongly suggests that Rellidep contains a mood altering ingredient or ingredients. This open-label, non-randomized study sets out to validate its potential antidepressant activity.The study will include secondary aims of evaluating the effect of Rellidep on reducing symptoms of anxiety, a common symptom associated symptom of depression and improving quality of life.

About twenty-five patients with major depressive disorder will be assigned to open-label Rellidep (2000 mg/day) for a period of 8 weeks. All patients will be assessed by various measures of global improvement, depression, quality of life, sexual experience, anxiety and measures of side effects as well as standard laboratory tests.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent obtained.
* Males/Females 20-65 years of age who require a new or a new change in their medication treatment for diagnosed major depression.
* A clinical diagnosis fulfilling DSM-IVTR criteria for Major Depressive Disorder, single episode or recurrent.
* 17-Item Hamilton Depression Rating Scale (HAMD 17-item) total score at baseline of 18 or higher

Exclusion Criteria:

* Clinical diagnosis of depression other than DSM-IVTR Major Depressive Disorder (single episode/recurrent, e.g. chronic depression and/or refractory depression are excluded).
* Judged to be at significant risk for suicide or having a history suggesting significant current potential for self harm.
* Antidepressant medication (other than the index antidepressant).
* Women who are pregnant or breast-feeding or intending to become pregnant in the next 12 months.
* Clinically significant organ system diseases, e.g. cardiovascular, hepatic, renal, endocrine, gastrointestinal, metabolic, or other systemic diseases.
* Course of electroconvulsive therapy (ECT) during the observational period.
* Suffer from a major neurological condition (i.e., Parkinson's disease, Huntington's disease), cerebrovascular disease (i.e., stroke), metabolic conditions (i.e., Vitamin B12 deficiency), autoimmune conditions (i.e., systematic lupus erythematosus), viral or other infections (i.e., hepatitis, mononucleosis, human immunodeficiency), and cancer.
* Current diagnosis of Schizophrenia or other psychotic disorders (including Schizophreniform Disorder, Schizoaffective Disorder, Delusional Disorder, brief psychotic disorders, psychotic disorder due to general medical condition, substance induced psychotic, psychotic disorder not otherwise specified) as defined in the DSM-IV.
* (Sub) clinical hypo/hyper thyroidism (e.g. elevated TSH).
Predictive Value of Granulosa Cell DNA Damage in the Success of Assisted Reproductive Technique

Deoxyribonucleic acid (DNA) damage of granulosa cells obtained during oocyte retrieval will be evaluated by flow cytometry with detection of Histone H2A.X and Phosphorylated Gamma H2A.X protein levels in patients with low ovarian reserve and unexplained infertile patients as a control group undergoing intracytoplasmic sperm injection (ICSI) treatment. Fertilization, embryo quality, transfer rate, implantation, clinical pregnancy will be recorded as well as demographic data. DNA damage of granulosa cells will be compared between two groups. The effect of DNA damage of granulosa cells on fertilization, quality of oocyte and embryo, implantation, and clinical pregnancy will be also evaluated.

Granulosa cells surrounding the oocytes will be mechanically obtained during the oocyte pick-up procedure in women undergoing intracytoplasmic sperm injection (ICSI) treatment due to unexplained infertility and low ovarian reserve. Deoxyribonucleic acid (DNA) damage in these cells will be evaluated by flow cytometry. Fertilization rates, embryo quality by grading, and transfer rates will also be assessed. Implantation and clinical pregnancy rates will be recorded as well as demographic data such as age, body-mass index, smoking, alcohol use, employment, coexisting chronic disease, infertility duration, etiology of infertility, treatment protocol. Implantation will be evaluated by determination of serum human chorionic gonadotropin (hCG) at day 15 following an embryo transfer. Clinical pregnancy will be diagnosed upon presence of gestational sac on ultrasound examination. DNA damage of granulosa cells will be compared between low ovarian reserve group and control group. The effect of DNA damage of granulosa cells on fertilization, quality of oocyte and embryo, implantation, and clinical pregnancy will be also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* For patients who are undergoing in Vitro Fertilization (IVF) treatment with Low ovarian reserve, Antimullerian Hormone level must be lower than 1 ng/mL
* For patients who are undergoing in Vitro Fertilization (IVF) treatment with Unexplained infetility, Antimullerian Hormone level must be greater than 1,5 ng/mL

Exclusion Criteria:

* Chronic systemic disease (rheumatoid arthritis, hypertension, diabetes..)
* Endocrinopathy (Thyroid, prolactin... abnormalities)
* Chemotherapy or radiotherapy history
* Endometriosis
* Policystic ovary syndrome
* Male infetility
Hemoperfusion Efferon СT for the Extremely Severe Form of COVID-19

The development of acute respiratory and renal failure of COVID-19 patients is associated with an excessive immune response and hyperproduction of anti-inflammatory cytokines, which leads to impaired endothelial function and a dysregulated balance between the coagulation and fibrinolytic systems in the blood. These factors contribute to the development of multi-organ failure, sepsis, and high mortality rates.In the absence of effective etiotropic therapy for COVID-19, it is necessary to search for alternative, pathogenetically based treatment approaches, including extracorporeal methods of homeostasis support. This observational study examines the effect of early hemoperfusion using the Efferon CT device for the treatment of patients with severe forms of COVID-19 after their intubation on a ventilator.

On March 11, 2020, the World Health Organization (WHO) declared COVID-19 a global pandemic. This disease is characterized by a variety of symptoms, many of which can lead to multiple organ failures and critical conditions.Timely removal of cytokines and other medium-molecular substances from the body using sorption techniques can not only help restore the balance between pro-inflammatory and anti-inflammatory mediators, but also in some clinical situations, prevent the deterioration of vital organ function or create conditions that allow for the reversal of multiple organ dysfunction.The accumulated experience of using various devices for sorption of low- and medium-molecular toxins creates a pathophysiological basis for the development of effective methods for the use of extracorporeal hemoperfusion in the treatment of the most severe forms of COVID-19.

This study examines the effects of early hemoperfusion, using the Efferon CT device, for the treatment of severe cases of COVID-19 in patients after intubation on a ventilator.

Efferon CT (Efferon JSC, Moscow, Russia) is a device for extracorporeal blood purification using direct hemoperfusion. Detoxification is carried out by removing excess cytokines, myoglobin, endogenous and exogenous toxic substances from the patient's blood. The device is manufactured according to TU 32.50.50-001-12264678-2018, passed the necessary tests and is registered in Russia as a medical device RZN 2019/8886.

Eligibility Criteria:
Inclusion Criteria:

* Patients with extremely severe COVID-19 no later than 6 hours after the start of intubation on a ventilator
* Patients over 18 years and under 72 years old

Exclusion Criteria:

* Pregnancy or the first 3 months after childbirth
* Clinical or laboratory findings of sepsis
* Acute bleeding
* Presense of cancer in anamnesis
* Surgical interventions
* Acute kidney injury (KDIGO \> I)
* Charlson comorbidity index \> 5
* Thrombocytopenia with a platelet count less than 100x109/L
* Patients in the first 6 months after acute cerebrovascular accident or acute myocardial infarction
* Patients who have previously undergone extracorporeal detoxication
A Non-invasive Index of Microciculatory Resistance

Coronary artery microvascular disease (CMVD) lacks reliable and non-invasive quantitative diagnosis methods. Improving coronary microcirculation has become one of the main goals of coronary heart disease treatment. In this study, by establishing the key influencing factors of myocardial microcirculation perfusion, an accurate three-dimensional reconstruction method of coronary artery was established, and a non-invasive coronary microcirculation resistance index (CT-IMR) calculation method based on computational fluid method mechanics was established. At the same time, a phase I single-center clinical verification and a multi-center clinical verification of the non-invasive coronary microcirculation function precision assessment system were carried out, and a non-invasive coronary microcirculation detection system and technology were established.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be older than 18 years
* Written informed consent available
* Subject is indicated for invasive coronary angiography
* Subject need to be taken within 30 days after enrolment

Exclusion Criteria:

* Previous PCI or CABG
* Subject is not eligible for measuring IMR
* Complicated complex congenital heart disease
* Artificial pacemaker or internal defibrillator leads implanted
* Implanted artificial heart valve
* Severe arrhythmia including complete AV block, ventricular arrhythmia
* Impaired chronic renal function (serum creatinine\>1.5ULN)
* Allergic to iodine
* Pregnancy
* Body mass index \>35 kg/m2
* Left ventricle is markedly thickened
* Needs for emergency procedures
* Severe distortion of in the blood vessel
* Unstable haemodynamics including abrupt chest pain cardiogenic shock, unstable blood pressure (systolic \< 90mmHg), severe congestive heart failure or pulmonary edema
* Life-threatening diseases (life expectancy \< 2 months)
* Tako Tsubo syndrome (TTS)
* Others who are inappropriate subject judged by clinician
A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures

The objective of this study is to evaluated the efficacy and safety of the reverse total shoulder prosthesis (RTSA) for complex proximal humerus fractures. The clinical results of RTSA will be compared to clinical results from a historical cohort, that received a hemiarthroplasty of the shoulder.


Eligibility Criteria:
Inclusion Criteria:

* Fracture or fracture dislocation not suitable for non-operative treatment or for osteosynthesis due to displacement and comminution
* Patients older than 65-years of age, or younger than 65-year of age if the surgeon assesses the physiological age as older.
* All patients, regardless of age, with an insufficient or irreparable rotator cuff

Exclusion Criteria:

* Brachial plexus palsy
* Previous ipsilateral fracture of clavicula, scapula, or proximal humerus
* Cognitive disabilities or substance abuse enabling rehabilitation and follow-up
* Patients without a Danish civil registration number
Evaluation of the Prognostic Value of T7 and T12 Slices on Mortality in Resuscitation Patients With ARDS Caused by SARS-COV2 Infection

Sarcopenia is a risk factor for adverse outcome in critically ill patients. Sarcopenia might be estimated from muscle surface measure on tomodensitometry.

The purpose of the study is to identify if muscle surfaces measured on thoracic tomodensitometry are associated with mortality in patients with acute respiratory distress syndrome due to SARS-Cov-2.


Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized in intensive care for SARS-Cov-2 infection since january 2020
* Thoracic TDM within the 30 day preceding ICU admission and up to 24 hours after ICU admission

Exclusion Criteria:

* Pregnancy
* Neuromuscular disease
Using tDCS to Enhance Learning of a New Walking Pattern

The ability to change walking patterns is important for daily tasks such as stepping over an obstacle. This change of walking pattern can occur in a strategic manner, i.e., consciously making one step longer or shorter. Healthy individuals can learn a new walking pattern through perturbed visual feedback of their walking information (Kim et al., 2015; Kim et al., 2017). This type of learning is thought to largely involve explicit strategy. Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that can enhance learning of some motor tasks (Reis et al., 2009), and primarily has been studied in the upper extremity. In locomotor learning, prior recent work by the investigators has suggested that tDCS does not affect non-strategy based locomotor learning, and the investigators speculate that tDCS may benefit learning of strategic tasks instead. The purpose of this study is to determine if tDCS can enhance learning and retention of a new walking pattern in a strategy-based, visually guided locomotor task in healthy individuals. Two groups of young, healthy participants will be recruited to learn a new walking pattern through perturbed visual feedback, with retention of learning tested on the second day. One group will receive tDCS, which is expected to enhance learning. The other group will receive placebo stimulation and serve as a control. Results from this work will provide information on which type of motor learning is sensitive to enhancement with tDCS, and may help pave the path for utilizing tDCS for neurorehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 years
* Medically stable and generally healthy
* Able to walk on a treadmill without the use of handrails for 20 minutes at a speed of 1.0 m/s without rest
* Resting heart rate ≤100 beats per minute
* Resting blood pressure ≤140/90 mm Hg
* Willing and able to attend all testing sessions

Exclusion Criteria:

* Any chronic or recent medical conditions, including any musculoskeletal, cardiovascular, pulmonary, psychiatric or neurological diagnosis
* Any impaired sensation or weakness in either lower extremity
* History of serious traumatic head injury, defined as a loss of consciousness for more than 5 minutes and/or requiring medical treatment
* Any history of acute or chronic problems with balance or more than 1 fall in the last 12 months
* History of brain surgery
* Taking 4 or more medications
* Current or chronic pain located anywhere in the body
* History of seizures
* Currently pregnant (if a female of childbearing age)
* Currently taking any medications that act on the central nervous system
* Implanted pumps or stimulators above the shoulders
* Metal aneurysm, other metal surgical clip placement, or any other metal in the head, face, or neck, except for dental fillings
Preventing Violence by Teachers

Brief Summary:

Violence against children is regarded as a key contributor to poverty and damages lifetime prospects for children in disadvantaged communities. However, physical violence is legally accepted as a disciplinary measure in schools in 68 states worldwide. For example, in Tanzania, corporal punishment is still lawful at school. It is thus not surprising that recently very high rates of violence (\~90%) were found at secondary schools. For children of primary school age, no such information is available from representative samples to date.

Moreover, in recent studies teachers often report having to resort to violent disciplinary methods referring to a lack of nonviolent disciplinary alternatives . However, only few interventions that aim at equipping teachers with non-violent action alternatives in Sub-Saharan Africa have been implemented, and even fewer have been scientifically evaluated.

Thus, in this study the investigators will implement and assess the efficacy of an intervention aimed at reducing the use of harsh and violent disciplinary measures in schools. Interaction Competencies with Children - for Teacher (ICC-T) aims to enable teachers to use non-violent disciplinary measures and to strengthen their competencies in non-violent interactions. Previously its feasibility and efficacy were proven in secondary schools in Tanzania. The present study aims to adapt ICC-T to, and evaluate its efficacy on, primary school level. The training is expected to improve the teacher-student relationships, change teacher's attitudes towards corporal punishment and their use of violent disciplinary measures.

Sampling will be based on a matched cluster randomized controlled trial design. Study participants (i.e. students, teachers) will be recruited from 6 regions in Tanzania. In each region two primary schools from different districts will be included. From each school 80 pupils and minimum 20 teachers will be recruited. The final sample will comprise 960 pupils in the age-range between 9 and 12 years and at least 240 teachers from 12 different primary schools.

From each region one primary schools will be randomly allocated to the intervention group (that will receive the ICC-T intervention training) and the control group (that will receive no training). The study will have two data assessment points: baseline assessment prior to the intervention and follow-up assessment three months after the intervention. In addition, feasibility data will be assessed in the intervention group at the beginning and the end of the intervention.

Study measures will cover the following topics: socio-demographic data, common disciplinary measure used at school, attitudes towards violent discipline measures, students' mental health problems.

Eligibility Criteria:
Inclusion Criteria:

* • Written informed consent (if underaged by parents \& minors)

Exclusion Criteria:

* • Acute drug or alcohol intoxication

  * Acute psychotic disorder