cyrilzakka/clinical-trials huggingface dataset:
Contrast Nephropathy Associated FFA

After the use of iodinated contrast agents, there is a risk of developing contrast nephropathy. Limited data in the literature are available on the incidence of contrast nephropathy after fluorescein angiography (FFA), which is an iodine-free organic contrast. Additionally, factors associated with contrast nephropathy after FFA are not clearly understood. Our study aims to evaluate these points.

It is known that patients are at risk of developing contrast nephropathy after FFA with iodinated contrast media. However, although it is known that contrast nephropathy may develop after FFA with fluorescein, a non-iodinated organic contrast agent, there is very limited data in the literature.

In this study, we aimed to determine the incidence of contrast nephropathy after FFA for retinopathy evaluation and to evaluate the associated factors (age, gender, diabetes mellitus, hypertension, chronic kidney disease, baseline renal function, medications, etc.). Our study was planned prospectively. Patients over the age of 18 years who applied to Prof. Dr. Cemil Taşcıoğlu City Hospital Eye Clinic as outpatients and who did not meet the exclusion criteria and agreed to participate in the study will be included in our study. Age, gender, demographic, clinical and laboratory data of these patients will be recorded from the patient file and hospital data processing system. The definition of contrast nephropathy is defined as an increase in serum creatinine (SCr) ≥0.5 mg/dL or more than 25% of the baseline value in the study titled "Contrast-induced Kidney Injury:Focus on Modifiable Risk Factorsand Prophylactic Strategies", "Risk of nephropathy after intravenous administration of contrast material: a critical literature analysis. In this study, an increase of 0.3 mg/dL in serum creatinine within 48 hours after contrast was accepted. The definition of contrast nephropathy will be evaluated separately as both an increase of 0.5 mg/dl or 25% increase in creatinine value compared to baseline and an increase of 0.3 mg/dl compared to baseline. In this way, there are studies in which the frequency of contrast nephropathy was evaluated separately according to both criteria in the same study.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old. Patients with an indication for FFA. Those who agreed to participate in the study.

Exclusion Criteria:

* Patients with nephrotoxic drug exposure in the last two weeks
* Patients who underwent imaging management requiring the use of other contrast agents in the last month (such as coronary angiography, CT angiography)
* Patients with unstable hemodynamics
* Patients with obstructive uropathy
* Patients with end-stage renal failure with eGFR\<15
* Patients on a routine hemodialysis program
Assessment of Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients

This research will provide data on thermal condition of medical workers who use personal protective equipment from biological hazards. Aquired data will be used to define acceptable period of use for these protective costumes.

This research will recruit 6 volunteers. During 6 hours each subject will perform their work using protective costume. Heart rate, skin and air temperature under costume and hygrometric data will be registered. Also there will be questionnaires for volunteers for subjective assessment of thermal and moisture sensations.


Eligibility Criteria:
Inclusion Criteria:

* healthy individuals (based on medical screening)

Exclusion Criteria:

* endocrinological diseases and disorders
* health deviations at the time of the study
Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia

The objective of the study is to determine whether Panax Ginseng with multiple interactions with key components of brain signaling pathway, can augment the effects of antipsychotics in Schizophrenia. We are primarily interested to examine the actions of Ginseng combined with antipsychotics in improving the ways patients diagnosed with schizophrenia behave in social environment, store, process and retrieve information.

Schizophrenia is a serious mental disorder affecting individuals in multiple ways: behavior control, emotional and information processing and the functional levels conforming to societal norms. Despite recent advances in medication therapy in treating the target symptoms of schizophrenia , subsets of patients diagnosed with schizophrenia continue to exhibit negative symptoms ( social withdrawal,apathy, lack of drive )and cognitive impairment (memory, attention, judgment and reasoning). Recently, there has been interest to explore the efficacy of avenue of dietary and herbal supplements with known pharmacological actions in treatment and prevention of neuropsychiatric disorders, especially bipolar and schizophrenia.

We hypothesize that Panax Ginseng , with multiple interactions with chemical pathways in the brain described as neurotransmitter systems (Dopamine, GABA and NMDA ) can improve the residual symptoms of schizophrenia when added to the antipsychotics currently used in the treatment of schizophrenia. Furthermore, in view of previous studies of Ginseng in enhancing memory , we hypothesize that the standardized formulation of Ginseng (Ginsana-115 from Boehringer Ingelheim-Pharmaton,Switzerland ) will optimize the antipsychotics in cognition impairment and negative symptoms. In the 18-week RCT cross-over study, schizophrenic subjects will be treated with either Ginsana-115 ( 100 mg or 200 mg by oral route) or placebo in a cross-over design. we plan to recruit 60 subjects diagnosed as schizophrenia from the four sites : London-St. Thomas, Ontario, Canada; Kingston Ontario Canada; Thunderbay, Ontario Canada and Middlesex, United Kingdom.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* age 18-65 years
* DSM-IV diagnosis of Schizophrenia
* SANS score greater than 30

Exclusion Criteria:

* Current (past 12 months) substance use disorder
* Except nicotine dependence
* Major medical disorders : hematological disorder
* Chronic active hepatitis, acute hepatitis, cirrhosis of liver, AIDS
* Pregnancy and breast-feeding
* Neurological disorders including epilepsy
* traumatic brain injury
* HAM-D score greater than 24
PAS for Post-SCI Neuropathic Pain

The investigators have shown in incomplete SCI patients that long-term paired associative stimulation is capable of restoring voluntary control over some paralyzed muscles and enhancing motor output in the weak muscles. In this study, the investigators will administer long-term paired associative stimulation to patients with incomplete cervical level SCI and SCI- associated neuropathic pain, and investigate its effectiveness for neuropathic pain treatment.


Eligibility Criteria:
Inclusion Criteria:

* incomplete cervical spinal cord injury
* time from injury at least 1.5 years
* chronic SCI- induced neuropathic pain in the upper limb

Exclusion Criteria:

* Diagnosed brain damage, visible in MRI or CT.
* No activity in hands/fingers and no MEPs recorded from distal hand muscles.
* Epilepsy
* Metal inclusion in the head area
* High intracranial pressure
* Pacemaker
* Implanted hearing device
* Progressive diseases of spinal cord or brain (e.g. malignant tumors, degenerative diseases).
* Previous head or spinal cord injury affecting the motor performance of upper extremities.
* Congenital anomaly in the anatomical structure of spinal canal/cord or dura.
* Significant systemic disease or other condition that could cause neurological deficit, or may affect subject's capability to undergo investigation-related procedures.
* Acute severe infection.
* Contraindications for MRI.
* Current severe psychiatric diseases.
* Current chronic drug and/or alcohol abuse.
* Pregnancy.
* Pressure ulcer affecting the subject's capability to undergo the procedure safely
Effectiveness of Asthma Education Program Based on the Roy Adaptation Model

The aim of the study; to determine the effect of the education program given to individuals diagnosed with asthma based on Roy's adjustment model on their psychosocial adjustment to the disease and their quality of life.

In addition to the expected physiological effects of asthma on individuals, the course of the disease and the course of the individual's life will change as the duration of living with the disease increases. In order to improve the attitude towards the disease positively in asthmatic individuals, to ensure asthma control and to improve the quality of life by managing the process well, patients' behaviors against the disease should be improved. Regular repetition of trainings created within the framework of a specific plan to improve adaptation behaviors is one of the recommended steps to empower individuals with chronic diseases during the disease process. In this randomized controlled trial, individuals aged 18-64 years with a diagnosis of asthma, an asthma control test (ACT) score of 24-20 (partial control) or ≤19 (uncontrolled) and no secondary chronic disease other than asthma were included.

Eligibility Criteria:
Inclusion Criteria:

* Being in the age range of 18-64
* Diagnosed with asthma for at least 6 months
* To live in the city center
* Asthma control test (ACT) score 24-20 (partial control) or ≤19 (uncontrolled)
* Patients who voluntarily agreed to participate in the study

Exclusion Criteria:

* Has a secondary chronic disease other than asthma
* Diagnosed with neuropsychiatric illness
* Individuals with inability to understand or speak Turkish and sensory problems that prevent communication
A Comparison of Rocuronium 0.3 mg/kg, and 0.9 mg/kg for Induction of Anesthesia in Elderly Patients.

The number of elderly patients above 80 years is increasing and a large proportion of these patients will require surgery and anesthesia.

During anesthesia neuromuscular blocking agents (NMBA) are administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. There is a risk of residual neuromuscular block when using NMBAs like rocuronium.

The aim of this study is to determine the onset time, duration of action and effect on intubating conditions after rocuronium 0.3 mg/kg and 0.9 mg/kg in patients with age ≥ 80 years.

The number of elderly patients (\>80 years) is increasing and a large proportion of these patients will require surgery and anesthesia within the next decades. Elderly patients are at higher risk of major morbidity and mortality and are characterized by a reduction in cardiac output, liver function and renal function. These physiological changes influence pharmacodynamics and pharmacokinetics of drugs administered during anesthesia.

Rocuronium is a nondepolarizing neuromuscular blocking drug with an onset time of approximately 70 s and a clinical duration of action of approximately 50 min. according to previous studies. During anesthesia rocuronium is administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. Rocuronium is primarily metabolized in the liver (70 % unmetabolized via the bile) and excreted via the kidneys.

Onset time and duration of action of rocuronium should be assessed by objective neuromuscular monitoring. Also, this reduces the risk of residual neuromuscular block which is defined as a train of four (TOF) ratio less than 0.9. Especially elderly patients have a high incidence of residual neuromuscular block.

The collected data regarding the effect of rocuronium in elderly patients may change the treatment so these patients receive the correct dose for optimal intubating conditions. Also, detection of duration of action of different doses of rocuronium may reduce the risk of residual block and postoperative respiratory complications

The aim of this study is to determine the onset time, duration of action and effect on intubating conditions after rocuronium 0.3 mg/kg and 0.9 mg/kg in patients with age ≥ 80 years.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 80
* Scheduled to elective surgery (expected duration time of surgery \> 1 hour) under general anesthesia with intubation and use of rocuronium.
* American Society of Anesthesiologists (ASA) physical status classification I to III
* Informed consent (see appendix 1)
* Read and understand Danish

Exclusion Criteria:

* Neuromuscular disease
* Known allergy to rocuronium
* Prone position
* Indication for rapid sequence induction
Home-based Exercise Training During Covid-19 Pandemic in Post-bariatric

The aim of this study is to assess the effect of a home-based exercise training during social isolation due to covid-19 pandemic in patients who undertook bariatric surgery.

Eligible patients will be invited to participate in the study by phone call. The research team will visit the included patients. All patients giving the written consent will perform the following tests before being randomly allocated into exercise training or control: 1) blood pressure; 2) anthropometric measures; 3) blood sampling; 4) handgrip test; 5) sit and stand test; 6) exercise capacity; 7) nutritional recalls and 8) health-related questionnaires. Patients will be randomized in a 1:1 ratio to control group (will receive information to keep active and eating healthy) or exercise training group (will receive a telemonitored exercise program through video conference, three times a week, during 3 months). Following 3 months of intervention, the outocomes will be re-assessed.

Eligibility Criteria:
Inclusion Criteria:

* Men and women submitted to bariatric surgery in the last 12 months.
* Not engaged in regular exercise training programs.

Exclusion Criteria:

* Patients with \>12 months of post-operatory period.
* Patients with diagnosed mental disorders.
* Patients with physical limitations or not allowed by the physician to exercise.
* Patients infected with Covid-19 at the time of data collection.
A Telemedicine Prenatal Care Model on Low Risk Pregnants: The m@Mae-e Study

This study will compare the effectiveness of a prenatal care supported by telemedicine against usual care in low-risk pregnant women. The investigators will follow-up women in a gestational age of 6 weeks up to 41 weeks, and 6 postpartum weeks. The primary outcome is the anxiety level estimated by the General Anxiety Scale 7 scale (GAD-7 Scale).

This is a pragmatic, effectiveness, superiority randomized clinical trial (RCT), in which low risk pregnants will be randomized to a prenatal care program supported by telemedicine or usual care in an allocation ratio of 1:1. The follow-up period will last 41 weeks from inception (i.e., 6 to 13 weeks of gestational age) to pregnancy and a extension period of 6 weeks in the postpartum stage. The investigators settled anxiety levels estimated by the General Anxiety Scale 7 scale as primary outcome in a between-groups mean difference after the 3rd trimester. Secondary outcomes include: delivery mode, obstetric events and fetal and neonatal variables of epidemiological surveillance interest (birth weight, birth height and APGAR score; maternal, fetal and neonatal fatal and non-fatal events). The interventions will occur as follows: for usual care, all appointments (at least 9 outpatient clinic visits) will be carried forward in person by a senior obstetrician. Patients randomized for the telemedicine supported group should will attend at least 6 in person and 3 online appointments. All pregnant women will receive the standardized care throughout the study. The sample size calculation was based on the primary outcome, assuming between-groups mean difference of 4 points plus a 4-points standard deviation, at a statistical of 80% and a two-tailed 5% type I error. Further, a 15% of addition was done for potential impairments during the follow-up, ending in 30 patients per group. The m@mae-e study's setting will be the at Santa Casa de Misericórdia, (Porto Alegre, Brazil).

Eligibility Criteria:
Inclusion Criteria:

* Low-risk pregnant (as classified an attending physician and/or the study's obstetrician);
* Gestational age less at 13 weeks or more in the moment of the first appointment;
* Portuguese native speaker.

Exclusion Criteria:

* Pregnant involving: hypertension or diabetes mellitus (any type) previous diagnosis;
* Obesity (BMI equal or greater than 35 m/kg2;
* Previous diagnosis of severe Sars-CoV-2 2019-related (COVID-19) infection which needed hospitalization;
* Previous thromboembolic event;
* Acute or chronic hematological events/diseases; use of anticoagulants or anti platelet aggregation drugs;
* Chronic cardiovascular, lung or kidney disease and cancer requiring treatment;
* Immunosuppression state;
* Severe mental disorder - major depression, generalized anxiety (and others anxiety-related disorders), bipolar disorder, schizophrenia and personality-related disorders in an uncontrolled manner for at least 1 year;
* At least more than one abortion;
* History of premature birth;
* An enrolled patient living in the same house;
* Plan to move the city.
Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation

The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing elective spinal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be scheduled to undergo an elective open posterior spinal fusion procedures with multilevel instrumentation, 10 to 60 days after study vaccination.
* Subject must be available for the entire duration of the study, and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including completion of the electronic diary for 10 days after study vaccination.
* Aged 18 to \<86 years old

Exclusion Criteria:

* Planned spinal fusion procedure requiring separate operations performed on separate days (ie, staged procedure).
* Surgical indication of malignancy, infection or acute or emergency trauma.
* History of major surgery within 3 months prior to enrollment, or anticipated major surgery other than the Index Surgical Procedure between study enrollment and completion of study participation.
* History of any spinal surgery performed within 6 months prior to study enrollment.
* History of any previous spinal surgery resulting in postoperative BSI or SSI.
* Congenital or acquired immunodeficiency disorder, rheumatologic disorder or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies within a year of enrollment or the use of systemic corticosteroids for \> 14 days within 30 days prior to enrollment.
* History of leukemia, lymphoma, underlying bone marrow disorder or history of bone marrow transplant.
The Effectiveness of a Serious Game Targeting Interpersonal Emotion Regulation in Early Adolescents

Background: Adaptive interpersonal emotion regulation (iER) is a vital tool for positive relations. During early adolescence, peer relations become increasingly important, making this age group a relevant target group for interventions promoting positive interactions with each other, yet no evidence-based intervention exists for early adolescents specifically.

Methods: This randomized controlled trial (RCT) aims to test effectiveness and feasibility of a serious game training iER skills in early adolescents by comparing outcomes with a control group playing a game without psychoeducational content in a pre- and post-test design. German- and English-speaking early adolescents (10-14 years) are eligible for participation. IER skills improvement assessed by a vignette task is the primary outcome variable and will be analysed with a chi-square test. Feasibility and acceptability and variables such as emotional competence, personal emotion regulation, gender, and sex will be assessed by questionnaires.

Discussion: This RCT will test whether playing serious game about iER strategies will result in an improvement of iER skills and whether the game is feasible and acceptable for early adolescents with the ultimate aim to implement the game in school classes and help early adolescents achieve positive peer relationships.


Eligibility Criteria:
Inclusion Criteria:

* Between 10 and 14 years old
* Willing and able to provide written parental consent
* Willing and able to participate in filling out pre- and post-test online questionnaires, and playing a web-based game
* Able to read and understand German or English
* Access to a device with internet (computer, mobile phone, tablet)

Exclusion Criteria:

-
HERA FIb Registry for Patients With Atrial Fibrillation

The single-center HERA AFIb registry was created to assess real-world prevalence, demographic characteristics and management of patients with atrial fibrillation (AF) in the era of novel oral anticoagulant regimes (NOAC) presenting in the emergency department (ED) of University of Heidelberg

HERA AFIb is a single-center retrospective registry which enrolled consecutive cases presenting with atrial fibrillation at the emergency department of University Hospital of Heidelberg. Clinical parameters and characteristics for cases were assessed retrospectively. Follow-up was performed via review of medical reports, phone calls and postal queries. Outcome parameters included rates for all-cause mortality, non-hemorrhagic stroke, myocardial infarction and major bleeding.

Eligibility Criteria:
Inclusion Criteria:

* documented atrial fibrillation
* availability of at least one hsTnT measurement

Exclusion Criteria:

* lost to follow-up
Pilot Study of OXP005 to Assess Gastroduodenal Irritation

Oxford Pharmascience Ltd (the Sponsor) is developing a new naproxen tablet formulation (the study drug, OXP005), for the potential treatment of rheumatic and painful conditions. The study will compare the study drug to an already marketed formulation of prescription strength naproxen (Naprosyn® the reference product) by looking at the relative impact of both products on gastroduodenal (GD) irritation by performing a specialist procedure called an endoscopy (or more specifically, a gastroscopy). The safety and tolerability of the study drug will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subject
* Healthy, normal upper GI tract as indicated by no ulcers or erosions at baseline, as assessed by the gastroenterologist conducting the endoscopy (ie Lanza score of 0 in both the stomach and duodenum)
* H. pylori negative

Exclusion Criteria:

* Clinically significant abnormal laboratory parameters
* Any clinically significant diseases or conditions affecting the haematopoietic, cardiovascular, renal, hepatic, endocrine, pulmonary, centralcnervous, immunological, dermatological, GI or any other body system