cyrilzakka/clinical-trials huggingface dataset:
Varenicline Adjunctive Treatment in Schizophrenia

The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.

This is a double-blind, placebo controlled clinical trial in schizophrenia patients. Outcome measures include biomarkers and clinical symptoms and functions, and smoking cessation. Neurobiological and cognitive markers will be measured for short term (2 weeks) and longer-term (8 weeks). Current schizophrenia treatments are mostly ineffective against primary negative symptoms and the cognitive and information processing deficits associated with the disorder. Previous research has identified several neurophysiological deficits in schizophrenia that are enduring, frequently occurring before psychosis, and mark the disease liability. These schizophrenia endophenotypes provide important targets for novel treatment development as they represent the core deficits of the disorder. We hypothesize that sustained nicotinic and dopaminergic modulation by varenicline may ameliorate the core neurobiological deficits seen in schizophrenia patients, which would lead to subsequent clinical improvement. Neurobiological and neurocognitive markers and clinical and functional measures will be obtained to determine 1) short-term effect of varenicline on biomarkers; and 2) longer-term improvement in clinical symptoms, smoking cessation, and functions; and how biomarker changes predict these improvements.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60
* DSM-IV Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder
* Clinically stable with no change in antipsychotic medications and increase of daily dose for 4 weeks prior to enrollment
* Sufficient understanding of the study and risks (ESC score 10 or above)

Exclusion Criteria:

* Major medical illness history including, but not limited to, history of heart attack, stroke, TIA (transient ischemic attack)
* History of organic brain disorders that may affect neurophysiological measurements, including seizure disorder, brain tumor, head injury with evidence of significant cognitive deterioration
* DSM-IV diagnosis of substance dependence within 6 months except nicotine and marijuana
* On nicotine replacement therapy (nicotine patch, gum, or nasal spray)
* Uncontrolled blood pressure (persistent systolic above 155 or diastolic above 95)
* EKG of second or third degree atrioventricular (AV) block
* Renal insufficiency with estimated creatinine clearance \<40 ml/min
* Women who have positive urine pregnancy tests
* Women who are pregnant, plan to become pregnant, or in breastfeeding
Safety and Immunogenicity of an Inactivated Vaccine Against COVID-19 in Medical Workers

With the unprecedented morbidity of the COVID-19 pandemic, the vaccine effectiveness needs to be assessed across diverse populations. The purpose of this study is to evaluate the safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in medical workers.

1370 participants who were negative for serum-specific antibodies against SARS-CoV-2 at the time of screening were enrolled and were receive a two-dose schedule, 21 days apart, with 4 μg BBIBP-CorV inactivated SARS-CoV-2 vaccine. The primary safety outcome includes solicited local and systemic reactions prompted by and recorded in an electronic diary within 7 days post each injection, unsolicited adverse events and serious adverse events assessed from the receipt of each dose, and clinical laboratory abnormalities from dose 1 through 1month after dose 2. Laboratory tests included measurement of alanine aminotransferase, aspartate aminotransferase, serum total bilirubin, serum albumin, creatinine, blood urea nitrogen, and blood routine examination. Immunogenicity was assessed as the serum anti-SARS-CoV-2 specific antibody responses and neutralizing activity at 4 weeks after the second vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent according to ICH/GCP regulations prior to any trial specific procedures.
* Male or female aged 18-59 years.

Exclusion Criteria:

* NA
Incidence of Methicillin Resistant Staphylococcus Aureus (MRSA) Carriage Rates in Resident Physicians

One hundred new residents will be recruited prior to the start of residency and followed prospectively for a year. Monthly nasal swabs will be performed to identify colonization with methicillin resistant staphylococcus aureus (MRSA).The proportion of study subjects colonized with MRSA at the end of 1 year will be calculated.

This is a prospective observational study looking at the incidence of MRSA colonization. New residents will be monitored every month with nasal swabs.We would like to elucidate factors responsible for MRSA colonization in healthcare workers.We would like to see if health care workers who are colonized spontaneously cleared MRSA and if there was any factors involved.

Nasal swabs will be plated on the spot by trained individuals and the plates then incubated for 48 hours. Plates will be read by microbiologist after incubation.

Eligibility Criteria:
Inclusion Criteria:

* Study subjects will be newly appointed residents at the OU medical center

Exclusion Criteria:

* Previous MRSA infection
* Current use of mupirocin
Improving the Health Care in Inflammatory Bowel Disease.

Inflammatory Bowel Disease (IBD) refers to two chronic diseases (Crohn's disease and Ulcerative colitis) both complex disorders requiring a long-term management, with significant healthcare resource consumption. Traditionally IBD patients has been treated by a variety of health care professional including doctors with specialist qualifications, assistant doctors, general practitioner or scarcity of follow-up-service. Lately there has been a shift in the health care service from conventional follow - up (CF) to a rising numbers of health care models in term of Multidisciplinary team (MDT) also including care for IBD patients. MDT- models have been identified as important for continuity in patient centred care where nurses have a key role within the team by enhancing patient care. Patients have directly access to the IBD nurse who performing independently consultations at the IBD - Policlinic. This study will test the hypothesis that MDT including an IBD - nurse is preferable concerning; patient reported Health Related Quality of Life (HRQoL) Quality of Care (QoC), and clinical outcomes including adherence. This will be a retrospective clinical quality survey with a single time point measurement, with consecutive recruitments of patients in the course of a 12-month period. Data will be collected from medical records and patient questionnaires. Investigators plan involving 300 participants aged \>18 and \< 80 recruited from Medical departments in North Norway and from Diakonhjemmet in Oslo. Half will be from CF-models and half from the IBD - MDT. The study have approval from the local Ethics committee and application to the Data protection Officer has been submitted. All participants are asked for provide written consent. The results can potentially contribute; to a better utilization of health care resources, improve quality of health and quality of care. In a nurse-perspective, this organising model can be valuable in recruiting nurses by presenting a new challenging task concept, and identify the gaps in their own knowledge and skills. A well-established MDT can also be reasonable in a cost effective way by decreasing hospitalisation and fee up clinical spaces for the gastroenterologist.


Eligibility Criteria:
Inclusion Criteria:

* Diagnose duration \> 2 years, to ensure that the patients have some experience with IBD and their follow-up system, respectively

Exclusion Criteria:

* Non-Norwegian patients who will have difficulties understanding the questionnaires
* patients with cognitive disabilities
CAR-T for r/r Malignant Tumors in Children

This study is a clinical study of CAR-T treatment of patients with relapsed/refractory malignant tumors in children. The purpose is to evaluate the safety and effectiveness of chimeric antigen receptor T cells in the treatment of relapsed/refractory malignant tumors in children.


Eligibility Criteria:
Inclusion Criteria:

* Age 3-18
* Expected survival time ≥ 12weeks
* ECOG 0-2
* At least second-line or above chemotherapy failed
* Liver and kidney function, heart and lung function meet the following requirements:

Creatinine is within the normal range; Left ventricular ejection fraction ≥ 45%; Baseline blood oxygen saturation\>91%; Total bilirubin≤1.5×ULN; ALT and AST≤2.5×ULN

* Understand the trial and have signed the informed consent

Exclusion Criteria:

* Those who have graft-versus-host disease (GVHD) or need to use immunosuppressive agents
* Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer test is not within the normal reference range; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) Antibody positive; CMV DNA test positive; Syphilis test positive
* Severe heart disease
* Systemic diseases judged by the investigator to be unstable: including but not limited to severe liver, kidney or metabolic diseases that require medication
* Within 7 days before screening, there are active infections or uncontrollable infections that require systemic treatment (except for mild urogenital infections and upper respiratory tract infections)
* Those who have received CAR-T therapy or other genetically modified cell therapy before screening
* According to the researcher's judgment, it does not meet the situation of cell preparation
* Situations that other researchers think are not suitable for inclusion
Critical Limb Ischemia and Transcutaneous Oximetry

Retrospective analysis of transcutanesou oximetry (Tcpo2) recording for patients referred with suspected critical limb ischemia searching for specific changes in TcpO2 patterns.

* Patients had Tcpo2 recording at the suspected limb and chest level at rest in the lying position.
* Provocative tests (leg elevation, leg lowering, oxygen inhalation) were performed to improve the sensitivity of tests.
* TcpO2 results were recorded on a 1 Hz bais for of line analysis after anonymization.
* We recorded age , gender, weight, height, ongoing treatments , History of cardiac or respiratory disease.

Visual and mathematical analysis of the TcpO2 recording at the chest and limb level searching for various indices of TcpO2 variability at rest, or differences in responses between the chest and limb tcpO2 responses to provocative tests..

Eligibility Criteria:
Inclusion Criteria:

* Referral for suspected critical limb ischemia

Exclusion Criteria:

* Absence of recording, deny to use medical file
Mechanism of Nitric Oxide on Ventilator-induced Diaphragm Dysfunction with Extracorporeal Membrane Lung Assistance

The goal of this clinical trial is to explore the effect of NO treatment on diaphragm function after mechanical ventilation with ECMO assistance. We expect to enroll a total of 80 patients who will receive mechanical ventilation and mechanical ventilation combined with ECMO treatment. Depending on the indication, they will be given NO treatment or not. In ECMO assisted mechanical ventilation + NO treatment group, the subjects will be randomly assigned to NO treatment via ventilator or membrane oxygenator. The main questions it aims to answer are:

1. Observing the influences and potential therapeutic effects of different NO insertion methods through ventilator or membrane oxygenator on the occurrence and development of ventilator-induced diaphragm (VIDD) dysfunction during ECMO assisted mechanical ventilation.
2. Exploring the potential key molecular mechanisms of NO treatment on the occurrence and development of VIDD after ECMO assisted mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. Tracheal intubation in our emergency department;
3. Expected survival time ≥ 72 hours;
4. Family members agree to participate and sign the informed consent form.

Exclusion Criteria:

1. Pregnant women;
2. Patients with diaphragmatic hernia or other known diaphragmatic diseases and injuries;
3. Patients with mechanical ventilation treatment within 3 months;
4. Thoracic or abdominal tumor invading the diaphragm;
5. A large amount of ascites raises the diaphragm position;
6. Upper respiratory tract malformation;
7. Trauma leading to chest collapse, etc.
EBUS-TBNA Versus EBUS-TBNB

A prospective diagnostic clinical study randomising patients undergoing endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of enlarged mediastinal and hilar lymph nodes to have sampling using the usual EBUS-TBNA needle or a novel biopsy forceps (EBUS-TBNB).

The study aims to establish whether the use of EBUS-TBNB can significantly increase the diagnostic yield over EBUS-TBNA, without an increase in complication rates.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for EBUS-TBNA as part of clinical care
* Lymph nodes larger than 10mm in diameter
* Age \> 18 years
* Able to provide written informed consent

Exclusion Criteria:

* Contraindications for needle or forceps biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia)
* Inability to obtain informed consent
Platelet Aggregation During the Shift From Clopidogrel to Ticagrelor

Antiplatelet therapy with ticagrelor is currently indicated for treatment of patients presenting with acute coronary syndrome. Such therapy is started with the administration of a loading dose in patients which are not yet under treatment with P2Y12 inhibitors (antiplatelet agents). However it is unknown whether a loading dose is needed to maintain a satisfactory inhibition of platelet aggregation in patients who are already treated with a previous generation P2Y12 inhibitor (clopidogrel) during the passage to the newer compound ticagrelor. For this reason aim of the present study is to evaluate the levels of platelet aggregation during the pharmacological shift from clopidogrel to ticagrelor performed with or without a loading starting dose of the newer drug.


Eligibility Criteria:
Inclusion Criteria:

* Acute Coronary Syndrome
* Current dual anti platelet treatment with ASA and Clopidogrel

Exclusion Criteria:

* No coronary revascularization within the previous six months
* Ongoing therapy with ticagrelor, prasugrel or ticlopidine before enrollment
* No treatment with glycoprotein IIb/IIIa inhibitors within the previous 6 days
* Patients which are known to be no responders to Clopidogrel
* Known neoplastic or autoimmune disease
* Liver cirrhosis
* Severe pulmonary disease
* Known disorder of Haemostasis
* Previous Stroke
* Ongoing pregnancy
* Therapy with any inhibitor of P450 Cytochrome until 15 days before enrollment
* Low platelet count or Hb\<10 g/dl
The Effect of NB-UVB on Interleukin-36 Levels in Psoriasis

Psoriasis is an immune-mediated skin disease that affects 1-2 % of the population. Several cytokines have been found to be involved in the complex pathogenesis of this disease. Il- 36 is one of the cytokines sharing in psoriasis pathogenesis, as its levels are elevated in psoriatic plaques. Cathepsin G is known to activate Il- 36 and promote inflammation in psoriasis.NB-UVB is one of the important treatment modalities for psoriasis.

The aim of this study is to detect the effect of NB-UVB on the lesional levels of IL-36 in psoriasis.

25 psoriasis patients will receive 26 sessions of phototherapy (NB-UVB). Patients will receive 3 sessions per week. Tissue levels of IL-36 and Cathepsin G will be assessed in skin lesions before starting treatment and after completing the 26 sessions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with psoriasis vulgaris of both sexes
* Age between 18 and 60 years old.

Exclusion Criteria:

* Pregnant females
* Patients receiving systemic treatment or topical treatment for psoriasis within the past two months.
* Patients having other dermatological diseases.
Understanding the Neural Mechanisms Behind tDCS

The aim of the study is to investigate the neural mechanisms underpinning transcranial direct current stimulation (tDCS), a non-invasive neuromodulation technique in which a direct current is passed through scalp electrodes. A series of experiments will be conducted to understand and characterize the transcranial and transcutaneous mechanisms of tDCS. To investigate this research question, every participant will undergo three stimulation conditions (active, sham and control). In the control condition, an anaesthetic cream will be applied to anaesthetize the nerves in the scalp. In addition, the effectiveness of tDCS and peripheral nerve stimulation will be compared. Ultimately, the obtained knowledge can lead to the development of improved non-invasive neuromodulation therapies, which can lead to more effective treatments of a variety of neurological and psychiatric disorders.


Eligibility Criteria:
Inclusion Criteria:

* good general health

Exclusion Criteria:

* Epilepsy or family history of epilepsy
* Migraine
* Allergic to lidocaine or benzocaine
* Pregnant
* History of or currently suffering from:
* neurological diseases
* psychiatric diseases, depression or anxiety (Annex B and Annex C)
* History of:
* brain surgery
* brain thrombosis
* cerebral hemorrhage
* severe head trauma
* meningitis
* long period of loss of consciousness (\> 1 hour)
* Metal parts in the head or upper body:
* Defibrillator, implanted medication pump
* Metal prosthesis in ear, hart, ...
* Deep brain stimulator
* Coronary bypass or intracranial or aneurysm clips (brain arteries, aorta, etc.)
Neural Adaptations to a Single Session of Metronome-Paced Strength Training

The aim of the study is to investigate the effects of incorporating variability within a single session of Resistance Training (RT) methods on the neural adaptations along the corticospinal tract and on neuromuscular function. The literature suggests that RTis one of the most common modalities to enhance and restore muscle function and its practice results in adaptation in neural and morphological adaptations. Moreover, it is also known that muscle contraction relies on the coordination and regulation of the descending neural drive from the motor cortex to the motoneurons and from the motoneurons to the muscles. However, traditional RT programs tend not to address this motor control dimension. Recent approaches such as metronome paced strength training have been used to cover this motor control dimension through a greater control and consciousness of movement. However, this methodology tends not to incorporate the inherent variability and complex, fractal-like fluctuations that characterize human movement. The investigators propose that incorporating variability through a fractal-like metronome approach will speed up the neural adaptations which will be useful in injury rehab


Eligibility Criteria:
Inclusion Criteria:

* healthy males
* aged between 18 and 40 years

Exclusion Criteria:

* Neurologic conditions;
* Lower limb disabilities or disease;
* Not able to provide informed consent;
* Have an implanted device (e.g. pacemakers) or any metal in the body;
* Medication advised against the application of Transcranial Magnetic Stimulation;
* History/family history of seizures, brain lesions or head trauma, neurological or psychiatric diseases, epilepsy, migraine
SIMDiscovery: The Benefits of Utilizing a Simulation Preparation Program for Spinal Fusion Surgery

This is a pilot study aiming to examine preliminary effectiveness of a preparation program which includes simulation (SIMDiscovery) in reducing anxiety and increasing feelings of preparedness among parents and their children who will undergo spinal fusion surgery. SIMDiscovery is an experiential learning preparation program which aims to educate children and families about different medical procedures through simulation play.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents with adolescent idiopathic scoliosis and their parent(s)
* Spinal fusion surgery scheduled
* Developmental Age range (10+; no upper age range)
* Males and females of all races and ethnicities
* English-speaking families (although English need not be their primary language)
* Both patient and caregiver (when patient is under 18 years of age) are able to attend SIMDiscovery program

Exclusion Criteria:

* - Other significant chronic medical conditions (e.g., spina bifida, muscular dystrophy)
* Anterior surgical access
* ICU stay expected post-op
* Cognitive functioning level below 10yo
Therapeutic Treatment of Amyotrophic Lateral Sclerosis

The goal of this study is to investigate the safety and tolerability of allogeneic Wharton's jelly-derived mesenchymal stem cells administration in the individuals with diagnosed amyotrophic lateral sclerosis.

Amyotrophic lateral sclerosis (ALS) is one of the progressive neurodegenerative disorders, affecting upper and lower motor neurons in the cerebral cortex, brainstem and spinal cord. Hence, the signs of damage motor neurons are both at the peripheral (eg. atrophy), and central (eg. spasticity) level. There is no effective treatment for ALS and the majority of patients die within 5 years after diagnosis, usually due to the respiratory failure. Numerous studies on murine models revealed that mesenchymal stem cells (MSCs) successfully improve the clinical and pathological features of ALS patients. The goal of this nonrandomized, open label study is to investigate the safety and tolerability of allogeneic Wharton's jelly-derived mesenchymal stem cell transplantation into the individuals with diagnosed amyotrophic lateral sclerosis. This clinical trial is conducted to test the therapeutic (neuroprotective and paracrine) effect of allogeneic Wharton's jelly-derived mesenchymal stem cells (WJ-MSCs). All patients enrolled will have a documented history of ALS disease prior to enrollment. Patients are recruited for a clinical trial no more than 1 year from the disease diagnosis. Then, patients are divided into two groups: Group I - patients receiving intrathecally one application of WJ-MSCs and Group II - patients receiving intrathecally three applications (each administration every two months) of WJ-MSCs. Subsequently, allogeneic Wharton's jelly-derived mesenchymal stem cell transplantation to the cerebrospinal fluid at the site of the spinal cord will be performed. Finally, treatment safety, adverse events and exploratory parameters, including electromyographic (EMG) studies, forced vital capacity (FVC) and functional rating scale (FRS) to establish ALS progression rate will be recorded throughout the duration and in the post-treatment follow up period.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of the ALS disease before the cell transplantation (diagnose established following the El Escorial criteria for definite ALS)
* good understanding of the protocol and willingness to consent
* signed informed consent
* disease duration: up to 2 years
* FVC \> 50% / pulmonologist certificate about respiratory function of the patient

Exclusion Criteria:

* cancer,
* autoimmune diseases
* renal failure,
* subject is a respiratory dependent.
* subject unwilling or unable to comply with the requirements of the protocol
* pregnancy, breastfeeding