cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Biomarkers of Response of TBS in Treatment Resistant Depression

Theta Burst Transcranial Magnetic Stimulation (TBS) in dorsolateral prefrontal cortex (DLPFC) has shown efficacy and safety as an adjuvant strategy for resistant to treatment depression (RTD) in daily sessions during 4-6 weeks (20-30 sessions). Current investigation in TBS aims to design intensive treatment protocols so as to achieve earlier responses and higher rates of efficacy. However, the implementation of TBS in the Public National Health Service requires cost-effective protocols that ensure and facilitate patients adherence to treatment, and whose design is based on clinical and neuroimaging biomarkers of response so as to adequately select candidate patients. The aim of this study is to assess the efficacy and safety of novel bilateral and unilateral intensive and spaced protocols of TBS in outpatients with unipolar and bipolar RTD compared with sham stimulation. Specific objectives: I) Comparison of mood change, response and remission of depressive illness at the end of TBS protocol in the groups and maintenance of its effect at 3 months; II) Characterization of neuroimaging cerebral connectivity networks and cerebral metabolism patterns of patients with RTD related to the effects of bilateral or unilateral TBS; III) Identification of clinical and demographic predictors contributing to response to TBS; IV) Analysis of the interaction between clinical, demographic and neuroimaging predictors so as to determine a RTD profile of patient that can benefit from TBS.

Participants will receive 22 bilateral sessions of sham/active continuous (right DLPFC) and intermittent (left DLPFC) TBS during 6 weeks. Simultaneous cerebral PET-MRI will be performed before (week 0) and after the treatment with TBS (week 7)

* Weeks 1 and 2: 1 session 5 days a week (10 sessions)
* Weeks 3,4,5, 6: 1 session 3 days a week (12 sessions)

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Major Depressive Episode or Depressive phase in Bipolar Disorder DSM-5 criteria.
* Moderate severity (\>14 points in HDRS)
* 2 antidepressant failures or failure in enhancing strategies in the case of bipolar depression.
* No changes in treatment 3 week previous to the onset of treatment with TMS.
* Ability to sign informed consent.

Exclusion Criteria:

* Any psychiatric comorbidity in axis I or II.
* Depressive episode with psychotic features.
* Dysthymia.
* Treatment with ECT in current depressive episode.
* Multiresistance (\> 6 trials of therapeutic strategies).
* Suicide risk assessed previous to each session.
* Patients who miss 2 TMS sessions in a row
* Neurological comorbidities (epilepsy, Parkinson disease, neurocognitive disorders).
* Contraindications to TMS: pregnancy, metallic cervical or head implants.
A Multi-Center Trial To Evaluate The Safety And Efficacy Of Pegaptanib Sodium(Macugen) Injected Into The Eye Every 6 Weeks For Up To 2 Years For Macular Swelling Associated With Diabetes, With An Open-Label Macugen Year Extension.

The purpose of the study is to test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy. The safety of Macugen compared to standard of care laser will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* macular edema associated with diabetes
* visual acuity between 20/50 and 20/200

Exclusion Criteria:

* recent laser therapy in the eye
* recent signs of uncontrolled diabetes
* blood pressure worse than 160/100
* severe cardiac disease
Infusion Treatments of Chronic Peripheral Neuropathic Pain

This study aimed to evaluate and compare the efficacy of ketamine and lidocaine infusion in patients with chronic peripheral neuropathic pain.

Patients who received intravenous ketamine infusion and the other patient group who received intravenous lidocaine infusion were evaluated in the study. Pain scores and quality of life were assessed with scales before treatment at two weeks, two months, and six months after treatment.

This study, it was aimed to evaluate and compare the efficacy of intravenous infusion of ketamine and lidocaine, which have been known and used in pain management and which have recently increased interest in the treatment of peripheric neuropathic pain.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* Patients with peripheral neuropathic pain (radicular neuropathy, diabetic neuropathy, complex regional pain syndrome type 2, traumatic peripheral nerve injury, trigeminal neuralgia, postherpetic neuralgia)
* Patients who was evaluated by DN4 scores with of ≥4 points

Exclusion Criteria:

* Patients with central nervous system disease .
* Patients with cancer related neuropatic pain.
* Patients with central neuropathic pain patterns.
* Patients with renal, hepatic, cardiovascular, and psychiatric diseases.
* Patients whose treatment could not be completed due to side effects or other reasons.
* Patients who had lost their follow-up .
Study of Effectiveness of Thoracic Epidural Analgesia for the Prevention of Acute Pancreatitis After ERCP Procedures

For 40 years, the post-ERCP (endoscopic retrograde cholangiopancreatography) pancreatitis has been the most frequent adverse effect of endoscopic transpapillary interventions. We sought to determine the efficacy of thoracic epidural analgesia for the prevention of post-ERCP pancreatitis.

Between 2008 and 2013, a randomized study of the results of endoscopic treatment of 491 patients was conducted. The first group of patients (N=247) received thoracic epidural analgesia (TEA) during ERCP procedures, the patients of the second group (N=244) received a narcotic analgesic. To detect statistically significant differences between research groups adjusted odds ratios (OR) and their 95% confidence interval (CI) were calculated.

Preoperatively the subjects were randomly assigned (by using sealed envelopes - blind randomization) into two groups, 250 patients each.

The patients of the first group had TEA applied during the ERCP procedure; other methods of pain relief were applied to the patients of the second (control) group.

The first group (TEA group) of patients received the following premedication: atropine sulfate 0.5-1 mg, midazolan 5 mg. The puncture and catheterization of the epidural space was carried out according to standard procedure between thoracic vertebrae VII-VIII. Half an hour before performing ERCP ropivacaine 0.5% -10 ml. was injected into the epidural space.

The second group (control group) of patients received the following premedication: atropine sulfate 0.5 -1 mg, midazolan 5 mg, trimeperidine 2% -1 ml.

Eligibility Criteria:
Inclusion criteria:

* Patients with performed therapeutic ERCP;
* The ERCP procedure was performed in a patient for the first time;
* Prior to the ERCP procedure the patient didn't have any clinical signs of acute pancreatitis.

Exclusion criteria:

- Development of complications during the ERCP procedure that required urgent surgical intervention (massive haemorrhage, Dormia basket avulsion and others).
Impact of Emicizumab on Activated Clotting Time Using the i-STAT Alinity Analyzer

Emicizumab (Hemlibra®) is a subcutaneous hemostatic treatment approved in 2019 for the prophylaxis in severe hemophilia A. Emicizumab is a bispecific monoclonal antibody mimicking factor VIIIa that provides a constant level of coagulation similar to that observed in minor haemophilia A patients whose factor VIII level is 10-15%. Although the correction of plasma coagulation in vivo is only partial, emicizumab strongly shortens the in vitro coagulation times involving the intrinsic pathway such as aPTT(activated partial thromboplastin time).

The investigators will evaluate the effect of emicizumab on a coagulation test (Activating clotting time (ACT i-STAT Alinity)) used as a point of care device to monitor heparin therapies during cardiac surgeries (cardiopulmonary bypass) and cardiac catheterizations. Because ACT is activated through the intrinsic pathway, it may also be shortened by emicizumab. Prophylactic treatment with emicizumab would make it impossible to use ACT for heparin therapy in a hemophiliac patient benefiting from this treatment.

The aim of this in vitro study is to assess the effect of emicizumab on the in vitro heparin-induced ACT increase in severe hemophilia A patients treated with emicizumab and in healthy volunteers (measurement on the i- STAT Alinity) thanks to in vitro blood spiking experiments.

Some data have already been published with other ACT devices (Hemochron..) but never with the i-STAT Alinity device which uses a different technology and other reagents.


Eligibility Criteria:
Inclusion criteria:

* severe hemophiliacs under emicizumab ( \> 4 weeks)

Exclusion Criteria:

* infusion of factor VIII \< 5 days
* patients refusing to participate in the study
* protected persons
* anticoagulants
rTMS to Enhance Cognitive Performance and Promote Resilience

The purpose of this study is to determine the most effective dose of brief, non-invasive brain stimulation (repetitive transcranial magnetic stimulation, rTMS) for improving cognitive functions such as attention and memory as well as to improve the ability to recover from stressful situations (stress resilience).

Repetitive transcranial magnetic stimulation (rTMS) works by rapidly turning a focused magnetic field on-and-off repeatedly over your head, which passes directly through your hair, scalp, and skull and onto your brain, and can temporarily increase brain activity under the magnetic field. Repetitive transcranial magnetic stimulation (rTMS) is an FDA approved treatment for depression, and is used commonly to treat people for their depression. The rTMS treatment regime used in this study is different from the FDA approved treatment because you will receive up to ten treatments per day over five days instead of the FDA approved rTMS treatment regime of 25 treatments over 25 days. This sort of accelerated or high dose protocol has been shown to be safe and effective in the treatment of depression. We are hoping to find out if this treatment can be used as a treatment for improving cognitive function and stress resilience.

Eligibility Criteria:
Inclusion Criteria:

1. No history of mental or physical illness
2. No implanted metal in the body
3. College graduates (Associates degree or higher)
4. Negative urine pregnancy test, if female subject of childbearing potential
5. Able to read and understand questionnaires and informed consent

Exclusion Criteria:

1. Any current psychiatric diagnosis or current Clinical Global Impression ratings of psychiatric illness \> 1
2. Current physical illness
3. History of CNS disease, concussion, overnight hospitalization, tumors, seizures, meningitis, encephalitis, abnormal CT/MRI of the brain
4. Moderate to severe traumatic brain injury (TBI)
5. History of a continuing significant laboratory finding
6. Frequent or severe headaches
7. Any history of psychotropic medication prior to study enrollment
8. Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
9. active participation or plan for enrollment in another evidence-based clinical trial affecting psychosocial function
10. repeated abuse or dependence upon drugs (excluding nicotine and caffeine)
11. implanted devices/ferrous metal of any kind
Bone Morphogenetic Protein-2 In Grade II Furcation Defects.

The present study evaluated clinically and radiographically the regenerative potential of rhBMP-2 in absorbable sponge and PRF in Grade II furcation.

44 subjects were enrolled in the study. PPD, CAL, plaque index and gingival index were recorded and the evaluation of bone fill was performed after 6 months by using ImageJ® software. After 6 months, the bone fill obtained with rhBMP-2 was higher when compared to PRF. From this trial conducted over a period of 6 months, the unique properties associated with rhBMP-2 in absorbable sponge makes it a potential agent to be used as a graft material for Grade II furcation defects.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy male and female patients of age group 20-55 yrs
* grade II furcation involvement and probing pocket depth of ≥5mm

Exclusion Criteria:

* Medically compromised patients
* subjects who underwent radiotherapy or chemotherapy in the past 12 months
* patients having uncontrolled periodontal disease and
* subjects smoking ≥10 cigarettes per day were excluded
Dynamic Alterations of Th2/Th1 With New Onset of Community-acquired Severe Sepsis Patients

To evaluate the dynamic alterations of Th2/Th1 for the prediction of clinical immunity and how it was related to 28 day-prognosis and ICU-acquired infections among critically ill patients of community-acquired severe sepsis with new onset.


Eligibility Criteria:
For community-acquired severe sepsis group:

Inclusion Criteria:

* at least 18 years of age and no more than 90 years of age
* sepsis was defined according to consensus criteria
* diagnosis of sepsis and complicatied with organ dysfunction no longer than 48 h
* provided written informed consent.

Exclusion Criteria:

* diagnosis of hematological,immunological disease or cancer
* treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization

For non-severe sepsis ICU control group:

Inclusion Criteria:

* at least 18 years of age and no more than 90 years of age
* without diagnosis of sepsis and admitted to ICU
* provided written informed consent.

Exclusion Criteria:

* diagnosis of hematological,immunological disease or cancer
* treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization

For healthy control group:

Inclusion Criteria:

* at least 18 years of age and no more than 90 years of age
* provided written informed consent.

Exclusion Criteria:

* diagnosis of hematological,immunological disease or cancer
* treatment with chemotherapy agents or corticosteroids within 6 months prior to enrollment
Establishment of Cohort Under the Guidance of the Pathogenesis of Cancer Toxin in Traditional Chinese Medicine

The study aims to investigate the potential mechanisms by which the interaction between the microbiota and tumors leads to the occurrence and development of cancer by collecting clinical information and biological samples from healthy individuals and cancer patients.

Study Design Types: A prospective, multicenter, observational study.

Observation Content:1.Healthy Individuals:General Information (Demographic Data), Traditional Chinese Medicine Physical Quality Scale, Biological Samples (Fecal, Blood, Tongue Coating, Tongue Appearance Photos, Tissues). 2.Malignant Tumor Patients: General Information (Demographic Data, Disease Information, ECOG Performance Status Score, MDASI Anderson Symptom Inventory), Traditional Chinese Medicine Cancer Toxin Syndrome Scale, Traditional Chinese Medicine Physical Quality Scale, Laboratory and Examination Data, Biological Samples (Fecal, Blood, Tongue Coating, Tongue Appearance Photos, Tissues).

Observation Time Points:1.Healthy Individuals: At the time of enrollment. 2.Malignant Tumor Patients: At the time of enrollment, 1 month after enrollment, every 3 months thereafter until tumor progression.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for healthy individuals:

* Age ≥ 18 years old;
* Informed consent and signed informed consent form.

Inclusion criteria for patients with malignant tumors:

* Patients with malignant tumors diagnosed by pathology or cytology;
* Advanced stage patients who have not received modern medical treatment in the past, or early to mid-stage patients who have completed postoperative radiochemotherapy for ≥ 1 month;
* Age ≥ 18 years old;
* Informed consent and signed informed consent form.

Exclusion Criteria:

Exclusion criteria for healthy individuals:

* Patients with malignant tumors diagnosed by pathology or cytology;
* Those who have taken any antibiotics/probiotics within 1 month before biological sample collection;
* Those with other immune or infectious diseases;
* Those with severe damage to the heart, liver, lungs, or kidney functions;
* Pregnant women, or those with mental illnesses such as depression or schizophrenia;
* Those deemed ineligible for the study by the researcher.

Exclusion criteria for patients with malignant tumors:

* Patients with multiple primary cancers;
* Those who have taken any antibiotics/probiotics within 1 month before biological sample collection;
* Those with other immune or infectious diseases;
* Those with severe damage to the heart, liver, lungs, or kidney functions;
* Pregnant women, or those with mental illnesses such as depression or schizophrenia;
* Those deemed ineligible for the study by the researcher.
Switch of Budesonide-formoterol Dry Powder Inhalers at Pharmacy in Norway

This is a retrospective, multicentre, non-interventional, observational study in patients with asthma and/or COPD who are treated with budesonide-formoterol.

In July 2018 Norwegian authorities decided to allow switch at pharmacy for dry powder inhalers (DPIs) containing budesonide-formoterol. Pharmacists are instructed to switch patients to the inhaler with the lowest price. The pharmacist will train the patient on how to use the new inhaler. All patients whose eligible inhaler switch occurred between 1st July 2018 and 1st March 2019 will be eligible for the study.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent has been obtained.
2. Male or female patients with a diagnosis of asthma and/or COPD whose budesonide-formoterol DPI was switched to another budesonide-formoterol DPI at pharmacy between 1st July 2018 and 1st March 2019 (referred to as the eligible switch).
3. Age ≥12 years at time of switch.
4. Treated with budesonide-formoterol for at least 12 months before the eligible switch (pre-switch period) and 12 months after the eligible switch (post-switch period). Re-switch(es) of inhaler are allowed during the post-switch period.

Exclusion Criteria:

1. Patient has declined participation in the study or failed to respond to the invitation to participate.
Early Family Based Intervention in Preterm Infants

This is randomized controlled trial investigating the effect of early intervention in very low birth weight infants after discharge from NICU on neurodevelopmental outcome. Other than control group of VLBW infants, study population includes term infants to compare neurodevelopmental outcome.


Eligibility Criteria:
Inclusion Criteria:

* preterm infants \< 32 weeks of gestation or 1,500 gm of birth weight
* normal term infants

Exclusion Criteria:

* major congenital anomaly
* neuromuscular disease
* chromosomal anomaly
* triplets or more multiplets
Esophagogastroduodenoscopy (EGD) is an Aerosol-generating Procedure: Proof of Concept Study

The disease COVID-19 has been classified as pandemic by World Health Organisation (WHO) in March 2020. This poses a risk to healthcare workers. Whether esophagogastroduodenoscopy (EGD) is a aerosol-generating procedure (AGP) has brought controversy. Multiple international guidelines consider EGD as AGP based on expert consensus. No scientific data has been published regarding this. With a commercially available particle counter, we can differentiate the particle counts of different sizes in different areas of the endoscopy room. An increase from baseline particles of \< 5um during or after the procedure would suggest that the procedure is an AGP. The baseline particle counts before and during the procedure are also recorded. The details of the procedure including procedure time and the use of sedation are also documented.

The disease COVID-19 has been classified as pandemic by World Health Organisation (WHO) in March 2020. This poses a risk to healthcare workers. Whether esophagogastroduodenoscopy (EGD) is a aerosol-generating procedure (AGP) has brought controversy. Multiple international guidelines consider EGD as AGP based on expert consensus. No scientific data has been published regarding this. Currently, the term droplet is often taken to refer to droplets \>5 microns (μm) in diameter that fall rapidly to the ground under gravity, and therefore are transmitted only over a limited distance (e.g. ≤1 m). In contrast, the term droplet nuclei refers to droplets ≤5 μm in diameter that can remain suspended in air for significant periods of time, allowing them to be transmitted over distances \>1 metre. With a commercially available particle counter, we can differentiate the particle counts of different sizes in different areas of the endoscopy room. An increase from baseline particles of \< 5um during or after the procedure would suggest that the procedure is an AGP. With the use of a commercial available particle counter, the number of particles of size (0.3um, 0.5um, 0.7um, 1um, 5um and 1um) are recorded. The baseline particle counts before and during the procedure are also recorded. The details of the procedure including procedure time and the use of sedation are also documented.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing EGD in the endoscopy unit of Prince of wales Hospital, Shatin, Hong Kong

Exclusion Criteria:

* EGD cannot be completed due to patient's condition
* Patients who are unstable and require extra medical attention
* Patients who refuse
* Patients who are not fit for consent
Green Management Intervention Program For Nurse Managers

Green management is the organization-wide strategy that aims to integrate environmental sustainability development into organizational management procedures for maintaining safety and striving high quality of care. The study aimed to examine the effect of a randomized trial of a green management intervention program on nurse manager outcomes.

Green management is the organization-wide strategy that aims to integrate environmental sustainability development into organizational management procedures for maintaining safety and striving for high-quality care. The study aimed to examine the effect of a randomized trial of a green management intervention program on nurse manager outcomes.

The study design was a randomized controlled trial using two-group pretest-posttest designs, according to Consort's 2010 statement. The study was conducted on 100 nurse managers in each intervention and comparison group at Alexandria University Hospitals. Data was collected from April 2023 to December 2023 using questionnaires of nurse managers' knowledge of green management and nurse manager outcomes. The researchers met the nurse managers to clarify the study objectives and reply to any questions and queries. The data were collected using self-administrated questionnaires related to the personal demographic characteristics of nurse managers, nurse managers' knowledge of green management and nurse manager outcomes. The data were collected during the implementation of the green management intervention program.

Eligibility Criteria:
Inclusion Criteria:

Nurse managers

* Work in General wards, and critical and intensive care units.
* Willing to participate in the study.
* Sign informed consent.
* Have at least one year of experience.

Exclusion Criteria:

Nurse Managers

* Unwilling to participate in the study.
* Did not sign an informed consent.
* Absent from multiple training sessions or incompletely filled out the questionnaires.