cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Bivalirudin During Short-term Intervention of Non-infarction Related Artery After PPCI of STEMI

This is a randomized, open label, cohort study, in which a total of 100 patients will be enrolled and randomly assigned to receive bivalirudin or heparin in a 1:1 ratio during short-term intervention of non-infarction related artery for acute ST-segment elevation myocardial infarction after emergency percutaneous coronary intervention.

NACE, MACE, any type of BARC bleeding, stent thrombosis will be evaluated in 30 days and 6 months after recruitment.

The 2017 guideline gives a class IIA recommendation ('should be considered') for complete revascularisation in patients presenting with STEMI and multivessel disease, which is approximately 50% of the STEMI population. Staged multivessel PCI during hospitalization (3-5 days after PPCI) is common in contemporary practice.

Patients undergoing primary PCI should receive enhanced antithrombotic therapy, includes DAPT and and parenteral anticoagulant, which caused an increased bleeding risk. In addition, repeated use of heparin in a short time may increase the incidence of HIT. Direct thrombin inhibitor bivalirudin, demonstrated a reduced risk of bleeding and an overall favorable profile including reduced NACE.

This is a randomized, open label, cohort study, which is aimed to investigate the safety and efficacy of bivalirudin during short-term intervention of non-infarction related artery for acute ST-segment elevation myocardial infarction after emergency percutaneous coronary intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Acute STEMI (including patients within 12 h of symptom onset, or 24-48 h with recurrent or ongoing chest pain chest pain, persistent ST-segment elevation or new left bundle branch block.
* Staged intervention of non-infarction related artery within 5 days after PPCI during Hospitalization.
* Signed informed consent.

Exclusion Criteria:

* Cardiogenic shock.
* Received thrombolytic therapy or used any anticoagulant drugs within 48 hours before randomized.
* Active bleeding, recent bleeding events or bleeding tendency.
* History of surgery in the last 1 month.
* Suspicious symptoms of aortic dissection, pericarditis and endocarditis.
* Blood pressure \> 180/110 mmHg.
* Hemoglobin \< 100 g/L, Platelet count \<100×10(9)/L, Transaminase 3 times upper limit of normality or Creatinine clearance \<30ml/min.
* History of Heparin-Induced Thrombocytopenia.
* Allergic to any research drug or device.
* Pregnancy or lactation.
* Any condition that makes the patient unsuitable for PCI or may interfere with the study.
* Patient disagrees or fails to sign the written informed consent.
Urokinase Versus Video-assisted Thoracoscopic to Treat Complicated Parapneumonic Empyema in Childhood

A great controversy exists about which is the best method to perform the evacuation of the collection. The purpose of this study is to evaluate which is the best initial treatment to drain complicated parapneumonic empyema (stages II and III) in children: the present study raises a hypothesis of equivalence between both arms of treatment (chest drainage plus intrapleural urokinase or videothoracoscopic debridement).


Eligibility Criteria:
Inclusion Criteria:

* Patients less than 15 years of age with pneumonia and persistent fever, and complicated parapneumonic empyema (septation or loculation seen on ultrasound or Rx thorax)stages II and III requiring an intervention to drain

Exclusion Criteria:

* Existing contraindications or other previous conditions, hypertension, pneumothorax
Treatment Strategy of Ankle Fracture Combined With Deltoid Ligament Rupture

Ankle fracture is very common which is often combined with deltoid ligament injury. Although the incidence of deltoid ligament injury is high, but there is no unified and effective diagnosis method. Even whether the ankle fracture with deltoid ligament rupture needs surgical repair is still controversial. There is no high-level, multi-center, large sample, long-term follow-up clinical evidence to prove whether the repair of deltoid ligament is necessary or not. The main content of the project: 1 Achieve accurate classification of deltoid ligament rupture with intraoperative exploration. 2 Study the surgical indications and treatment guidelines by comparative study.

Comparative study for ankle fracture combined with deltoid ligament rupture: with \& without repair of ligament

Eligibility Criteria:
Inclusion Criteria:

* ankle fracture with deltoid ligament rupture

Exclusion Criteria:

* ankle fracture without deltoid ligament rupture
Skin Protection During Radiotherapy in Patients With Breast Cancer

Radiotherapy may cause severe skin changes that significantly interfere with the patient's quality of life and may reduce radiotherapy effectiveness. Many skin care instructions and various topical agents are recommended to help patients in the management of radiation skin reactions, but evidence to support the value of the topical treatments of the irradiated skin is lacking. In the present study we investigated the effects of two topical agents used as supportive care to protect skin during radiotherapy.

Women with breast cancer and were to receive breast radiotherapy to 50 Gy were enrolled in a prospective randomized trial to compare the effectiveness of Evoskin®) for protecting skin compared to Trixiera. To account for individual differences in radiation each subject served as her own control, as each was to apply the experimental and control agents to the irradiated breast. Each patient was randomly assigned to use Evoskin on the half of the irradiated breast and to use the Triexiera on the other half. Dermatitis was graded weekly by means of a spectrophotometer.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more
* Patients with breast cancer for which a treatment by radiotherapy is planned
* No concomitant chemotherapy
* Signed informed consent

Exclusion Criteria:

* Cutaneous neoplasia radiotherapy
* Total mastectomy
* Bilateral breast cancer
* Dark skinDiseases enhancing radiosensitivity Patient with a generalized skin disorder
* Pregnant, breast-feeding woman
A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral Tomivosertib (eFT-508) in Subjects With Hematological Malignancies

This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of Tomivosertib (eFT-508). The study will evaluate oral daily administration of Tomivosertib (eFT-508). Treatment and study subject evaluation will be performed in 21-day cycles.


Eligibility Criteria:
Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
2. Presence of an active hematological malignancy.
3. Presence of measurable disease.
4. Hematological malignancy has been previously treated, has relapsed after or progressed during prior therapy, and has limited potential for benefit from currently available therapy including hematopoietic stem cell transplantation.
5. At least 2 weeks post any treatments/therapies at the time of first dose.
6. Adequate bone marrow function.
7. Adequate hepatic function.
8. Adequate renal function.
9. Normal coagulation panel.
10. Negative antiviral serology.
11. Willingness to use effective contraception.

Exclusion Criteria:

1. Central nervous system malignancy
2. Gastrointestinal disease
3. Significant cardiovascular disease
4. Significant ECG abnormalities.
5. Ongoing risk for bleeding due to active peptic ulcer disease, bleeding diathesis or requirement for systemic anticoagulation
6. Ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections)
7. Pregnancy or breastfeeding.
8. Major surgery within 4 weeks before the start of study therapy.
9. Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids
10. Use of drugs that could prolong the QT interval within 7 days before the start of study therapy.
11. Use of drugs that might pose a risk of a drug-drug interaction within 2-7 days before the start of study therapy.
Influences of Long Term Hormone Therapy on Physical Fitness and Vascular Function in Transgender Women

Transgender women who transitioned from male to female by hormone therapy demonstrate similar physical fitness and vascular function to males or females.

This cross-sectional study was to compare physical fitness and vascular function between cisgender men, cisgender women, and transgender women.

Eligibility Criteria:
Inclusion Criteria:

1. Cisgender men group (Body mass index between 18.5-24.9 and NO NCDs).
2. Cisgender women group (Body mass index between 18.5-24.9, No pregnant, NO NCDs).
3. Transgender women with orchiectomy (Body mass index between 18.5-24.9, taking estradiol, testosterone level below 10 nmol/L, NO NCDs).
4. Transgender women without orchiectomy (Body mass index between 18.5-24.9, taking estradiol and anti-androgen, testosterone level below 10 nmol/L, NO NCDs).

Exclusion Criteria:

* Participants had an injury during testing.
Feasibility Study to Evaluate the Observance Rehabilitation of Upper Limbs by Visual-motor Simulation Associated at Transcranial Direct Current Stimulation (tDCS) in Hemiparetic Patient Post-stroke

Although the mirror therapy is recognized as effective, its practice is difficult, especially with hemiplegic patients. It is difficult for them to understand, control the movements and carry out a double task with the two upper limbs. The implementation of a Computerized Mirror Therapy (CMT) with the Intensive Visual Simulation 3 (IVS3) device makes it possible to limit these problems by proposing pre-recorded sessions, not limited to the right or left hemi-space, and proposing a work on proximal motricity. Since the functional prognosis of the upper hemiplegic limb remains mostly unfavourable, a wide range of interventions should be proposed. There is currently a consensus to consider the use of transcranial Direct Current Stimulation (tDCS) stimulation in functional recovery after stroke as a method to enhance the effectiveness of training techniques. Although all motor therapies can theoretically benefit from increased effectiveness by the addition of transcranial Direct Current Stimulation (tDCS), Computerized Mirror Therapy (CMT) has a high potential for sensitivity to transcranial Direct Current Stimulation (tDCS) due to the intensity of the motor training of the upper limb applied.

The primary objective of this study is to investigate the feasibility of a program combining Computerized Mirror Therapy (CMT) with dual- transcranial Direct Current Stimulation (tDCS) stimulation by evaluating observance to hemiparetic stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient with first ischemic or hemorrhagic stroke for less than one year, having not recidivated since then and responsible for initially complete left or right hemiplegia
* Modified Frenchay arm test score \<70 (/ 100)
* Without a neurological history other than stroke
* Having signed the written consent and affiliated or entitled to a social security scheme

Exclusion Criteria:

* Patient with contraindications to transcranial Direct Current Stimulation (tDCS) or Transcranial Magnetic Stimulation (TMS) (brain metal implant, pacemaker, other implanted active medical device)
* Patient who didn't have cerebral Magnetic Resonance Imaging (MRI) imaging during their stroke
* With complete lesion of the primary motor cortex
* With alcohol / drug dependence
* With psychiatric illness, cognitive impairment, uncontrolled disease / epilepsy, malignant disease, severe renal or pulmonary disease
* With a history of disabling associated disease
* With cerebellar syndrome
* Pregnancy
HPV-test, Cervical Cancer and Follow-up

The investigators have planned this project to evaluate the follow-up program after surgery due to cervical cancer and to explore the possibilities for different tests of Human Papilloma Virus (HPV) in contributing to the customization of the follow-up program.

Purpose:

The investigators effort is to provide the background for an evidence-based update of the follow-up program after surgery due to cervical cancer with the purpose of early diagnosis of recurrence affecting quality of life for as few women as possible.


Eligibility Criteria:
Inclusion Criteria:

* Surgery. FIGO stage IA-IB. \> 18 years

Exclusion Criteria:

* Ajuvant oncologic treatment
A Prospective Cohort Study on the Comorbid Depression in Patients With Newly-diagnosed Epilepsy

Epilepsy is a chronic brain disease with recurrent seizures and the comorbidity of psychiatric diseases are very common. The prevalence of depression in patients with refractory epilepsy is about 60%. However, the early diagnosis is usually difficult due to the unclear mechanism and untypical clinical symptoms, and there are no extremely effective treatments for depression in patients with epilepsy until now. In this prospective, multi-center, cohort study, we aim to investigate and screen two different types of depression ("cognitive" and "somatic") in patients with epilepsy by using the combination of regular moods evaluating scales and heart rate variability instrument. The intervening methods of combining transcranial direct current stimulation (tDCS) and serotonin re-uptake inhibitors (SSRIs) are used to treat the patients with comorbidity of epilepsy and depression.

Epilepsy is a chronic brain disease with recurrent seizures and the comorbidity of psychiatric diseases are very common. The prevalence of depression in patients with refractory epilepsy is about 60%. However, the early diagnosis is usually difficult due to the unclear mechanism and untypical clinical symptoms, and there are no extremely effective treatments for depression in patients with epilepsy until now. In this prospective, multi-center, cohort study, we aim to investigate and screen two different types of depression ("cognitive" and "somatic") in patients with epilepsy by using the combination of regular moods evaluating scales and heart rate variability instrument. The intervening methods of combining transcranial direct current stimulation (tDCS) and serotonin re-uptake inhibitors (SSRIs) are used to treat the patients with comorbidity of epilepsy and depression. And resting-state functional MRI will be conducted in patients with the comorbidity of epilepsy and depression before and after the combing treatment of tDCS and SSRIs.

Eligibility Criteria:
Inclusion Criteria:

* meeting the definition of epilepsy according to the new definition issued by ILAE in 2014
* not using antidepressants
* acquiring informed consents

Exclusion Criteria:

* patients with severe psychiatric symptoms;
* progressive brain diseases
* malignant tumors
* severe cognitive declines
The Neurobiology of Depressive Illness

We aim to determine why patients with depression are at an elevated risk for the development of coronary heart disease, and resolve whether the severity of a patient's depression has a counterpart in demonstrable abnormalities in brain chemistry. Studies will be completed in 28 patients with depression; both males and females. Patients will be studied both untreated and during administration of a selective serotonin re-uptake inhibitor (SSRI) antidepressant. They will be either newly diagnosed with depression, untreated patients suffering a recent relapse, or patients seeking to switch from a non-SSRI antidepressant due to non-response. The turnover of chemical messengers in the brain will be estimated by high internal jugular venous blood sampling and DNA will be isolated and examined from blood cells. Immune function will also be assessed. Whole body and cardiac sympathetic nervous activity will be determined, as well as microneurographic recording of muscle sympathetic nervous activity.

It is hypothesised that patients with depression and no existing demonstrable cardiac disease demonstrate:

Alterations in brain monoaminergic neurotransmitter turnover, resulting in sympathetic nervous activation and dysregulation of the baroreflex control to both the heart (vagal) and muscle vasoconstrictor sympathetic nerves; and Exhibit enhanced platelet reactivity predisposing them to thrombogenesis and myocardial ischaemia.

Therapeutic intervention with an SSRI will modify cardiac sympathetic function, baroreflex sensitivity or platelet reactivity in a fashion likely to reduce cardiac risk.


Eligibility Criteria:
Inclusion Criteria:

* Major depression

Exclusion Criteria:

* heart disease diabetes hypertension psychosis significant suicidal risk dementia
The Caring Universities Project: EsteemUp RCT

Within the Caring Universities project (study protocol VCWE- 2020-135 accepted by the VCWE), the investigators have developed a guided e-health programme (EsteemUp) designed to increase university students' self-esteem. With the current study, the investigators aim to examine the feasibility and acceptability of EsteemUp - with and without gamification elements - to improve students' self-esteem.

Secondary goals are to gain insight into pre-test to post-test differences regarding self-esteem, symptoms of depression, anxiety and quality of life.

The present study is a two-armed randomized controlled trial. This trial will be conducted in a university setting. Participants will be randomized to receive a version of the intervention either with gamification elements (EsteemUp-G) or without gamification elements (EsteemUp).

EsteemUp was developed based on existing literature on self-esteem and adapted in collaboration with university students to meet the specific needs of the university students. EsteemUp is based on cognitive-behavioural therapy (CBT) and consists of four modules that are delivered via computer, laptop, tablet, or mobile phone. Every module consists of evidence-based information, exercises, and homework assignments. The content is delivered in text format with pictures and infographics. The intervention is available in both English and Dutch.

Participants assigned to EsteemUp-G will receive the exact same intervention explained above with an addition of gamification elements. These elements include Badges, unlockable content, a. certification of completion at the end of the program, goal setting, gamification terminology and a progress bar.

Every week trained e-coaches (trained clinical psychology master students) will provide asynchronous written personalized feedback to each participant on the progress of the program and the exercises via the program platform. Measurements include post-test assessment of adherence, treatment satisfaction, and satisfaction with e-coach. Secondary outcomes include pre and post-assessment of self-esteem, common measures of psychopathology symptoms, and quality of life.

Data will be analysed based on the intent-to-treat principle.

All students currently enrolled at the participating universities (Vrije Universiteit Amsterdam, Erasmus University, InHolland University of Applied sciences, Universities of Amsterdam, Leiden, Utrecht and Maastricht) are potentially eligible for the trial.

Students can participate in EsteemUp free of charge, which will likely increase their self-esteem and confidence. They will not receive any additional incentives for participation.

Eligibility Criteria:
Inclusion Criteria:

To be eligible to participate in this trial, a subject must meet all the following criteria:

* Being fluent in Dutch and/or English
* Being enrolled as a student of the seven participating universities
* Being 16 years of age or older
* Having access to a PC or mobile device with internet access
* Provide informed consent before participation

Exclusion Criteria:

- None. All interested students are eligible to participate.
Comparing Hydrocortisone and Prednisolone for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)

The goal of this cluster randomized controlled trial is to determine the optimal treatment for Acute Exacerbation of Chronic Obstructive Pulmonary Disease. The study compares the effects and side effects of hydrocortisone and prednisolone in patients above 40 years old diagnosed with chronic obstructive pulmonary disease with acute exacerbation. The main question is whether there is a difference in readmission for COPD excerbation or all cause mortality within thirty days.

Participants will randomized to receive treatment with either hydrocortisone or prednisolone.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥40 years
* Chronic obstructive pulmonary disease with acute exacerbation, unspecified: ICDJ44

Exclusion Criteria:

* All diagnoses that would merit treatment with a specific corticosteroid
* Pregnant or breastfeeding women
* Active tuberculosis or invasive fungal infection
Carer Skills Training for Inpatients With Anorexia Nervosa (iCASK)

To improve treatment for patients with severe anorexia nervosa admitted for inpatient care, and to help their families. Inpatients and their families will be offered a novel intervention which includes multimedia training materials. These materials provide guidance in how families can provide support to maintain and build on changes made during inpatient care

Problem to be solved: Hospital Episode Statistics reveal that admissions for anorexia nervosa are increasing \[1\]. Admission restores nutrition in a timely manner \[2\], but psychosocial problems remain and relapse following discharge is common \[3\]. The mortality post discharge is high \[4\]. We have found that relapse and bed use post discharge are reduced by a parenting intervention giving the family skills to manage eating disorder behaviours \[5\].

Innovation: Through a process of co-production, in collaboration with service users and their families, we have developed tools exemplifying emotional coaching behaviour change strategies for patients and their carers (texts, DVDs and podcasts; iCASK programme). These aim of these tools is to improve the transition to outpatient care. These are hosted on a user-friendly, confidential and NHS-compliant platform.

Eligibility Criteria:
Inclusion Criteria:

* aged 17 or over
* DSM-5 diagnosis of Anorexia Nervosa with a body mass index (BMI) of \< 18.5 kg/m2

Exclusion Criteria:

* Insufficient knowledge of English
* Severe mental or physical illness needing treatment in its own right (e.g. psychosis or diabetes mellitus)