cyrilzakka/clinical-trials huggingface dataset:
Adverse Events Report of Inactivated COVID-19 Vaccine

Numerous vaccination studies are conducted to protect against COVID-19 infection, and preclinical and clinical studies are still ongoing worldwide. During this extraordinary period, the necessity to perform COVID-19 vaccine studies and immunization programs together has emerged. Many manufacturing companies have started mass production of vaccines accepting the risk of failure of vaccines during trials. Vaccine Adverse Effects (VAEs) need to be documented quickly. We aimed to determine the VAEs and to compare the frequency of VAEs between groups according to socio-demographic characteristics after the inactivated vaccine (Corona Vac®) was administered to healthcare workers (HCWs) in Turkey.

In this study, an online questionnaire was delivered to volunteer healthcare workers across the whole country. Sociodemographic characteristics, medical history, history of COVID-19 infection, and VAEs occurring after the first and second doses of inactivated vaccine were evaluated.

A new coronavirus, severe acute respiratory syncytial coronavirus 2 (SARS-CoV-2) first appeared in China at the end of 2019 and attracted attention with clusters of pneumonia-like cases, which were later defined as coronavirus disease 2019 (COVID-19). Vaccine development is usually achieved over decades and therefore it is unprecedented to have access to such a large number of approved vaccines for COVID-19. In this process, great efforts were made by many organizations to cope with this pandemic that affected the whole world.

COVID-19 vaccines with different features in the form of vector-mediated, messenger RNA (mRNA) or inactivated vaccines are being produced worldwide. CoronaVac® is an inactivated vaccine against severe acute respiratory syncytial coronavirus 2 (SARS-CoV-2) developed by Sinovac Biotech, China which was approved by World Health Organization (WHO) in June 2021.

Vaccine Adverse Effect (VAE) is defined as "any adverse medical event that occurs after vaccination, which is thought to be due to a vaccine.

The primary endpoint of our study was to evaluate the VAEs reported after the first dose and the second doses following the inactivated vaccine (CoronaVac®), which was administered to HCWs in our country as a dose of 3 µg twice, 28 days apart. The secondary endpoint was the comparison of the frequency of VAE development between groups according to socio-demographic characteristics.

Eligibility Criteria:
Inclusion Criteria:

1)The HCWs vaccinated with two doses of CoronaVac.

Exclusion Criteria:

1. The HCWs under 18 years old
2. The HCWs those couldn't be able to complete the questionnaire accurately.
Efficacy of Prevention for Postoperative Nausea and Vomiting After Intrathecal Morphine in Cesarean Section

Post-operative nausea and vomiting are the major complications after spinal anesthesia with intrathecal morphine, therefore antiemetic drugs should be administered for best satisfaction of anesthesia to prevent these complication.

Furthermore, administration of a combination of antiemetic drugs with different mechanisms of action appears reasonable and synergistic effect of drugs.

In conclusion, we study efficacy of antiemetic effect of single antiemetic drug compare with combination antiemetic drugs.

In this study : a randomized, double-blind, placebo-controlled, clinical trial comparing single doses of Metoclopramide 10 mg and Ondansetron 8 mg alone and a combination of Dexamethasone 5 mg and Metoclopramide 10 mg or a combination of Dexamethasone 5 mg and Ondansetron 8 mg for prevention of PONV after spinal morphine for cesarean section.

Inclusion criteria

1. Patient undergoes elective cesarean section age more than 18 years
2. Patient accepted in spinal anesthesia technique
3. ASA classification I-II
4. Patient understand question and evaluation process

Exclusion criteria

1. Hyperemesis gravidarum
2. Patient with ongoing antiemetic drugs treatment
3. Patient with history of drug allergy in Metoclopramide,Ondansetron and Dexamethasone

Outcome measurement By oral interview and nurse notification in 24 hr. post-operatively.

Detail of outcome measurement

1. Nausea and vomiting score
2. Pain score
3. Sedation score
4. Itch symptom
5. Patient satisfaction

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy patients undergo Elective cesarean section age more than 18 years
* Patient accept spinal anesthesia technique
* ASA classification I-II
* Patient understand question and evaluation process

Exclusion criteria:

* Hyperemesis gravidarum
* Patient ongoing treatment with antiemetic drugs
* Allergy to Metoclopramide,Ondansetron and Dexamethasone
PECS Block in Breast Surgery: an Observational Multicenter Study

We will enroll patients submitted to breast surgery (in and outsettings) with regional anesthesia.

The blinded observers, in the first 48 hours post-operative, will evaluate (telephone interview in outsetting) the pain intensity through the Numeric Rating Scale ( 0= no pain, 10 = worst possible pain) thereby recording the treatment procedures in accordance with usual clinical practice. At the same time we will evaluate the presence of intraoperative or postoperative complications related to regional anesthesia, the PONV rate (post-operative nausea and vomiting) and the analgesic/antiemetic therapy.


Eligibility Criteria:
Inclusion Criteria:

ASA I-II-III Patients Written Informed Consent

Exclusion Criteria:

ASA IV Active Heart Failure Coagulation Disease Chronic Pain Allergies to Local Anesthetics
Clinical Trial of Mesenchymal Stem Cells in the Treatment of Severe Acute Kidney Injury

Acute kidney injury(AKI) is a common, severe emergency case in clinics,especially severe AKI ,which is associated with higher morbidity and mortality. Effect of routine therapy is limited and mesenchymal stem cells (MSC)are considered a new therapy for treating severe acute kidney injury. Patients will be randomized to receive intravenous infusion of MSC, or placebo control. This trial is to investigate whether MSC can improve renal recovery and mortality of patients with AKI.


Eligibility Criteria:
Inclusion Criteria:

* Have severe AKI defined as more than two-fold increase serum creatinine level compared with baseline within 48 hours and/or urinary output consistently\<0.5 ml/kg/h over 12 hours
* Age between 18 and 65 years
* Willing or having a legally acceptable representative to give a written informed consent
* Able to comply with visit schedule and study procedures including post-hospitalization discharge follow-up

Exclusion Criteria:

* AKI due to post-renal outflow obstruction,glomerulonephritis,lupus nephritis, antineutrophil cytoplasmic antibody (ANCA) related nephritis, antiglomerular basement membrane disease, cryoglobulinemia, thrombotic microangiopathy, and AKI caused by purpura nephritis
* Pregnant or lactating woman
* Allergic person
* Organ transplant or hematopoietic stem cell transplant
* Patients with malignant tumors or those with a history of cancer
* Life expectancy is less than 3 months
* Known end-stage liver disease
* Uncontrollable infection
* Patients younger than 65 years old ,whose estimated glomerular filtration rate (eGFR) were less than 60
* Severe pulmonary dysfunction
* Severe cardiac dysfunction,left ventricular ejection fraction is less than 40%, or severe arrhythmia patients
* Hemodynamically unstable patients
* Organ failure affecting more than 2 non-renal organs
* Acute or chronic vasculitis of any cause
* History of chronic systemic infection of any cause
* The investigators believe that subjects may need to gradually increase the dose of vasopressor to achieve and / or maintain hemodynamic stability
* Systemic immunosuppressive therapy that has not been stabilized for greater than 4 months, or in the case of chronic corticosteroid therapy, a dose of \>15 mg/day of prednisone or the equivalent within the past 30 days
* Platelet count \<25,000/uL or other severe hematologic abnormalities, causing the subject to be at risk of death
* Patients need mechanical ventilation
* Participate in other clinical trials
Anonymous Survey of Breast Cancer Patients Concerning Their Use of Medical Apps

Breast cancer patients complete questionnaires concerning their use of medical apps.

Breast cancer patients of the department of gynecology at Technical University of Munich and Berlin Charité complete quesionnaires during routine appointments. Intention of the survey is to evaluate the importance of medical apps and the special needs of breast cancer patients. Moreover approaches to improve health care of breast cancer patients are expected to be developed.

Eligibility Criteria:
Inclusion Criteria:

* breast cancer patients
* patients who are legally competent and able to understand and follow instructions of the study staff

Exclusion Criteria:

* none
Tampa Kinesiophobia Scale Modified for Headache

Tampa Kinesiophobia Scale is a scale that has been validated and reliable in individuals with low back pain in the Turkish population and evaluates fear of movement due to the risk of triggering pain. Especially for migraine headache, patients have complaints about movement and fear of movement, and in addition, according to the International Classification of Headache Disorders, 3rd Edition criteria, the item of aggravation with physical activity is considered as a diagnostic criterion. Migraine patients may theoretically start their attacks due to hypocretin neuropeptide and lactate metabolism dysfunction. It has been stated that calcitonin gene-related peptide (CGRP), which is released during migraine attacks, is also released during exercise and intense physical activity and can trigger attacks. Therefore, patients avoid physical activity and exercise. It has been stated that movements that do not require effort can also trigger attacks in migraine patients, but this is not seen in tension-type headache. Cervicogenic headache is also a less researched topic in general, and there is not enough data on kinesiophobia in this area. The aim of this study is to investigate the validity and reliability of the Tampa Kinesiophobia Scale for Headache in patients with migraine, tension-type and cervicogenic headaches for the Turkish population. The potential relationships between the scale and the beliefs about headache severity, disability, quality of life, anxiety and depression will also be evaluated and whether the characteristics of the three types of headaches are similar or different from kinesiophobia will be investigated.

Hypotheses: H0: The Tampa Kinesiophobia Scale for Headache is not valid and reliable for the Turkish population in patients with migraine, tension-type or cervicogenic headaches.

H1: The Tampa Kinesiophobia Scale for Headache is valid and reliable for the Turkish population in patients with migraine, tension-type or cervicogenic headaches.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with episodic/chronic migraine, tension-type headache and cervicogenic headache
* Being between the ages of 18-70,
* Being able to read, speak, understand and write Turkish in order to understand and correctly answer the items/questions of the surveys and scales.

Exclusion Criteria:

* Having a diagnosis of episodic/chronic migraine, tension-type headache, and any headache diagnosis other than cervicogenic headache,
* Having a history of any systemic disease such as malignant, inflammatory, acute fracture, surgery, neurological, psychological, or rheumatological.
* Not being able to read Turkish.
Evaluation of Factors Associated With Patient Satisfaction and Mood-State in Regional Anesthesia

Patient satisfaction is an important subjective measure of healthcare quality which contributes to evaluation of the structure, process and outcome of services. The key factor in patient satisfaction is adequate perioperative information of the patient and communication between healthcare providers and patient or patient's kin.

There are few studies in anesthesia that have assessed patient satisfaction and mood-state during regional anesthesia.

The investigators aimed to evaluate factors associated with patient satisfaction from regional anesthesia procedure and mood-state of patients who underwent surgery under regional anesthesia.

Patient satisfaction is an important subjective measure of healthcare quality which contributes to evaluation of the structure, process and outcome of services. Many factors contribute to patient satisfaction, including institutional structure, interpersonal relationships, and a patient' expectations. Age, gender, social insurance, educational and social statue also play role in patient satisfaction. The key factor in patient satisfaction is adequate perioperative information of the patient and communication between healthcare providers and patient or patient's kin.

The success of regional anesthesia is influenced by several factors. Most patients expect uneventful perioperative process. Nevertheless, recovery from surgery and anesthesia is sometimes complicated by major and minor complaints including pain, nausea, vomiting and other. Although there is no scientific or clinical evidence that regional anesthesia is superior to general anesthesia, regional anesthesia has some advantages like keeping consciousness of the patient during surgery, continuation of spontaneous breathing, avoiding the loss of protective reflexes, allowing early mobilization in the postoperative period and shortening the length of hospital stay. However, the major contraindication for regional anesthesia is the patient's unwillingness.

There are few studies in anesthesia that have assessed patient satisfaction and mood-state during regional anesthesia.

The investigators aimed to evaluate factors associated with patient satisfaction from regional anesthesia procedure and mood-state of patients who underwent surgery under regional anesthesia.

Eligibility Criteria:
Inclusion Criteria:

- patients who underwent gynecological and obstetrical, urological, orthopedic and general surgical procedures under general anesthesia

Exclusion Criteria:

- clinically significant psychiatrically ill illiterate patients who received general anesthesia patients that have speech, hearing, or understanding problems
A PMCF Study to Confirm the Performance and Safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter

A post market clinical study to confirm the performance and safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter on patients undergoing surgical treatment for the removal of arterial emboli and/or thrombi

This prospective, single arm, post market clinical study was designed to proactively collect clinical data on the LeMaitre® TufTex Single Lumen Embolectomy Catheters and to confirm its performance in removing arterial emboli and/or thrombi, to identify and analyze emergent risks on the basis of factual evidence, and to ensure the continued acceptability of the benefit/risk ratio. This post market study is sponsored by LeMaitre® Vascular, Inc., the manufacturer of the device. Study will take place at 3 to 8 sites in Europe, the target sample size is 112 patients.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subject, ≥ 18 years of age at time of enrollment.
2. Subject who is scheduled to undergo surgical treatment for the removal of arterial or venous emboli and/or thrombi, where one of the LeMaitre® Embolectomy Catheter will be used.
3. Subject signed an Informed Consent for participation.
4. Subject diagnosed with a embolus/thrombus.
5. Subjects for whom thrombolytic therapy had failed or was contraindicated.

Exclusion Criteria:

1. Co-morbidity that in the discretion of the investigator might confound the results.
2. Subjects who are unable to read or write.
3. Pregnant or lactating women at time of enrollment
4. Subjects who are immune comprised
Sleep-Wake Patterns on Illness Trajectories and Treatment Response in MDD

The proposed study will include a longitudinal ecological study (Study 1) and a randomised controlled trial (Study 2). The aims will be to (1) identify the sleep-wake profiles in individuals with MDD through clustering; (2) examine the associations between sleep-wake features/profiles and the prognosis of MDD; and (3) investigate the anti-depressant effects of sleep- and circadian-targeted intervention in those with MDD and whether sleep-wake features/profiles may moderate the treatment outcomes. 70 depressed participants from Study 1 will be randomized to Study 2 for the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) group and the care-as-usual (CAU) group in a 1:1 allocation ratio. The study period will be 8 weeks. Major assessments at baseline and immediate post-treatment will be managed by an independent assessor (a research assistant, RA) who is blind to the group allocation. The proposed trial and the nested pilot study will follow the CONSORT and STROBE guidelines, respectively. The intervention will be provided free of charge.The current registration is only for Study 2 of the current research project.


Eligibility Criteria:
Inclusion Criteria for the MDD group:

1. Adults aged 18-65 years living in Hong Kong
2. Being fluent and literate in Cantonese
3. A Patient Health Questionnaire-9 (PHQ-9) score of at least 10, indicating a moderate level of depression.
4. Meeting the DSM diagnostic criteria for current MDD according to the Mini International Neuropsychiatric Interview (MINI)
5. Experiencing ≥ 1 sleep or circadian problem in the past 3 months according to the sleep and circadian problems checklist (i.e., time needed to fall asleep ≥ 30 minutes, wake after sleep onset ≥ 30 minutes, \< 6-hour sleep per night or ≥ 9-hour sleep per night per 24-hour period, and falling asleep after 2:00 AM ≥ 3 nights per week; and variability in the sleep-wake schedule ≥ 2.78 hours within a week)
6. Access to an Internet-enabled mobile device (iOS or Android operating system)
7. Willingness to provide informed consent and comply with the trial protocol.

Exclusion Criteria for the MDD group:

1. Severe medical or neurocognitive disorder(s) that make participation unsuitable based on the team's clinical experience
2. Presence of other psychiatric disorders as assessed by MINI
3. A history of electroconvulsive therapy (ECT)
4. Current involvement in any psychological treatment programme that targets depression and/or sleep and circadian problems
5. A change in the class or dose of any prescribed psychotropic drugs within 6 weeks before the baseline assessment
6. Shift work, pregnancy, or work, family, or other commitments that interfere with regular sleep-wake patterns
7. Presence of other untreated sleep disorders, including narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)/periodic leg movement disorder (PLMD) based on the cut-off scores of SLEEP-50 (narcolepsy ≥ 7; OSA ≥ 15; RLS/PLMD ≥ 7)
Linked Color Imaging vs White Light Imaging for Detection of Gastric Cancer Precursors

This study aims to examine the use of Linked Color Imaging in detection of gastric cancer precursors, as well as oesophageal and duodenal lesions.

Gastric cancer is the fifth most common cause of death worldwide. Early detection and removal of gastric cancer precursors and early gastric cancer is crucial for good outcomes. However, these lesions are subtle and often missed by conventional white light imaging (WLI) endoscopy. Image enhanced endoscopy techniques have been developed to enhance the detection and characterization of gastrointestinal lesions. Narrow band imaging (NBI) is one such technique. Though widely used, its drawbacks include a limited far view as a result of the optical filter causing a dark endoscopic view. Linked color imaging (LCI) is a more recent image enhanced endoscopy technique that acquires images by using both narrow-band wavelength light and white light in an appropriate balance, enhancing slight color differences in the red region of mucosa. It has been proven to improve detection of H pylori gastritis and colorectal neoplasms. Thus far, there has been no study to determine whether the use of LCI will increase the detection rate of gastric cancer precursors and early gastric cancer compared to WLI. This study aims to determine whether LCI can increase the detection rate of gastric cancer precursors and early gastric cancer when compared to white light endoscopy, with the null hypothesis being no difference in detection rates. This study will also examine the use of LCI with magnification to predict histology findings for focal lesions seen on endoscopy, as well as the use of LCI in identifying esophageal lesions (such as Barett's esophagus) and duodenal lesions.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 50 years and above
* Patients undergoing gastroscopy for symptom evaluation
* Patients undergoing gastroscopy for surveillance of known intestinal metaplasia

Exclusion Criteria:

* Emergent gastroscopy performed for suspected acute GI bleeding
* Patients with previous surgical/endoscopic resection in stomach
* Patients with deranged coagulation and platelet function (INR\>1.5, Plt\<50)
* Patients with severe comorbid illness (ASA 3 and above)
Impact of a Corrie Cardiac Rehabilitation Program

In this randomized clinical trial, the researchers are investigating whether a multi-component virtual/hybrid cardiac rehabilitation program will improve functional status, cholesterol level, overall cardiovascular health, individual risk factors, quality of life and mental health for patients who have recently been diagnosed with myocardial infarction, received a coronary stent, underwent heart surgery or catheter-based valve replacement, as compared to traditional, center-based cardiac rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Individuals admitted to the hospital for the following conditions or interventions during the index admission: Acute myocardial infarction (STEMI or NSTEMI type 1), Coronary artery bypass grafting (CABG), and Coronary artery angioplasty/stenting (PCI), Heart valve surgery, catheter-based aortic valve replacement (TAVR).

Exclusion Criteria

* Non-English speaking
* Symptomatic severe aortic stenosis or other severe valvular disease
* Physical disability that would preclude safe and adequate exercise performance
* Hypertrophic obstructive cardiomyopathy with peak resting left ventricular outflow gradient of \>25 mmHg
* Known aortic dissection
* Severe resting arterial hypertension (Systolic blood pressure \>200 mmHg or diastolic BP \>110mmHg) at baseline assessment
* Mental impairment leading to inability to cooperate with study procedures
* Untreated high degree atrioventricular block
* Atrial fibrillation with uncontrolled ventricular rate (Heart rate \>110 at rest) at baseline assessment
* History of cardiac arrest or sudden death
* Myocardial infarction or cardiac surgery complications with cardiogenic shock and/or congestive heart failure and/or signs/symptoms of post-procedure ischemia
* Left ventricular ejection fraction \<40%
* History of Clinically significant depression
* Visual or hearing impairment which precludes the use of the intervention
* Presence of cardiac defibrillator
* Incomplete revascularization procedure
* History of one or more episodes of falls in the last year
* Pregnancy

  * If patients are deemed clinically unstable and unable to participate at the time of initial screening, the research team member may return at a later date to determine whether this status has changed.