cyrilzakka/clinical-trials huggingface dataset:
A Study of the Effectiveness of Peginterferon Alfa-2a (Pegasys) and Ribavirin Treatment in Slovenian Hepatitis C (HCV) Patients

In this Slovenian, multi-center, observational study, the effectiveness of standard of care Peginterferon alfa-2a + ribavirin treatment in adult patients with chronic hepatitis C (CHC) is examined. Patients were treated for 24- or 48-weeks, as prescribed by the treating physician, followed by a 24-week follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients \>/= 18 years
* Positive test for HCV
* Effective contraception as specified by the Peginterferon alfa-2a and/or ribavirin labels

Exclusion Criteria:

* Concomitant infection with HIV or hepatitis B
* Participation in a clinical trial within 30 days prior to study start
* Any contraindications specified in the Peginterferon alfa-2a and ribavirin product labels
A Study of TQ05105 in Patients With Chronic Graft Versus Host Disease

This study was a single arm, open label, multicenter phase Ib / II trial in subjects with glucocorticoid refractory / dependent moderate to severe cGVHD.The trial consisted of two phases: phase I for the dose exploration and phase II for the extension study.


Eligibility Criteria:
Inclusion Criteria:

* Understood and signed an informed consent form.
* ≥18 years old, Karnofsky Performance Scale of ≥60, life expectancy ≥ 6 months.
* Has received allogeneic hematopoietic stem cell transplantation (alloSCT).
* Clinically diagnosed moderate to severe cGVHD according to NIH Consensus Criteria.
* Has received systemic or topical corticosteroids therapy and confirmed steroid-refractory/dependent cGVHD according to NIH Consensus Criteria.
* Has received at least 1 lines of therapy for cGVHD.
* Adequate laboratory indicators.
* No pregnant or breastfeeding women, and a negative pregnancy test.

Exclusion Criteria:

* Has active acute GVHD.
* Has previously failed to respond to JAK inhibitors for GVHD, or who had used JAK inhibitors within 4 weeks before the first administration.
* Has uncontrollable active infections or infections requiring systematic treatment within 7 days before the first administration.
* Development of other basic diseases.
* Has malignant tumors within 3 years.
* Has multiple factors affecting oral medication.
* Has substance abuse or a psychotic disorder.
* Has severe and / or uncontrolled disease.
* Allergic to drugs or its constituents.
* Has participated in any other clinical trials within 4 weeks before first administration.
* According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
ΔvapCO2 / Cav02 Ratio as a Prognostic Marker and Predictor of Complications After Cardiac Surgery

This study evaluates the usefulness of the ΔvapCO2 / Cav02 ratio to predict complications after elective cardiac surgery, comparing it with others markers such as lactate, arteriovenous CO2 difference (ΔvapCO2) and would try to developed a new predictive score for postoperative complications.

Cardiac surgery is widely used to solve valvular or coronary problems and often requires the use of cardiopulmonary bypass or extracorporeal circulation (EC).

The EC itself produces a series of changes in the macro- and microcirculation hemodynamic and physiological consequences in the hours following surgery that can be difficult to analyze.

During postoperatively management, different monitoring methods are used to optimize different hemodynamic and analytical variables.

Sometimes, monitored variables are corrected but the patient still develops complications such as kidney failure, prolonged mechanical ventilation or even death. In fact, it is not well known either if it is sufficient to correct the variables called "macrodynamics " such as mean arterial pressure (MAP) , stroke volume (SV), pulmonary artery occlusion pressure (PCWP) and cardiac index (CI) or if it is necessary to correct other "micro-dynamics" variables like lactate, to achieve a certain central venous oxygen saturation (ScvO2) or arteriovenous CO2 difference(ΔvapCO2).

In tissue hypoxia, damping of excess protons by bicarbonate increase CO2 production; therefore the relationship between CO2 production and oxygen consumption (VCO2/VO2 ratio or respiratory quotient) increases. This ratio can be simplified relating ΔvapCO2 and O2 content arteriovenous difference (ΔvapCO2 / Cav02 ratio). In shock, anaerobic metabolism is one of the primary energy source. In this situation, ΔvapCO2 / Cav02 is \> 1.

The evolution of the ΔvapCO2 / Cav02 ratio and its association with prognosis have nnot been studied yet after cardiac surgery.

The study's objectives are:

* to describe ΔvapCO2 / Cav02 ratios kinetics compared to lactate and other biochemical markers (troponin I, BE) in the first 12 hours after cardiac surgery.
* define if ΔvapCO2 / Cav02 ratio\> 1 after 6 hours of adequate postsurgical resuscitation correlates with worse prognosis in patients after cardiac surgery.
* develop a new prognostic score for postoperative complication that includes ΔvapCO2 / Cav02 ratio.

Blood gases and drawn from a central venous and arterial lines. pCO2, O2 content, lactate are analyzed at 0, 2, 6 and 12 hs. Macrodynamic variables are also collected, as well as, the need of extracorporeal support techniques.

Patients would be followed for the next 28 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more
* given informed consent
* elective cardiac surgery
* tip of a central venous catheter correctly positioned (superior vena cava or right atria)
* arterial catheter correctly positioned

Exclusion criteria:

* pregnancy
Neonatal Resuscitation - Sustained Inflations

This study compares a fifteen second sustained inflation (SI) to five repeated two - three second 'inflation breaths' during resuscitation at delivery of infants born prematurely.

Around 10% of newborns will require some form of assistance after delivery, with babies born more prematurely more likely to require resuscitation

Current UK guidelines advise initial resuscitation with the delivery of five 'inflation breaths' lasting 2-3 seconds with peak inflation pressure of 30cmH2O (20-25cm H2O in premature neonates). Previous studies have shown that despite resuscitation training, clinicians in both simulated and real resuscitation scenarios do not deliver the recommended duration of inflation breaths. This, combined with leaks around the facemask often being as large as 50% or greater, contributes to low expired tidal volumes during resuscitation, thus increasing the likelihood of hypoxia and delay in establishing effective respiration.

The use of sustained inflations (up to 15 seconds), rather than intermittent shorter inflation breaths, has shown promising results, with reduction in the need for intubation, and the need for and duration of mechanical ventilation. Around 30% of units in Germany use sustained inflations as first line delivery room management, as do many other hospitals around the world. Resuscitation guidelines from the USA, UK and Europe suggest that sustained inflations should be researched further.

Several studies have shown that for several lengths of inflation breaths, the expired tidal volume achieved is higher if the baby makes respiratory effort during the inflation (active inflation) and that stimulation of spontaneous respiratory effort is a key part in establishing an FRC, enabling spontaneous breathing, and increasing the likelihood of successful resuscitation.

To date, there are no studies directly comparing whether prolonged inflations are more successful at provoking an inspiration than other methods of resuscitation. We therefore aim to compare a 15 second sustained inflation to repeated shorter inflations to determine which is more effective.

Eligibility Criteria:
Inclusion Criteria:

* Infants born at less than 34 weeks gestation requiring resuscitation at delivery

Exclusion Criteria:

* Major congenital abnormalities
* Parents have previously expressed lack of consent for study
Comparing Simplified EEG Monitoring Tool With Standard EEG Monitoring in Patients With Acute Neurological Insult

After any acute brain injury, a primary pathophysiological response arises, enabling the brain to develop seizures and/or a status epilepticus (SE). These are frequently reported in patients admitted to the intensive care unit (ICU) with traumatic brain injury and brain injury caused by subarachnoid or intracerebral hemorrhage. Seizures can be presented without any clinical motor signs, which are then termed as nonconvulsive, and therefore remain frequently clinically unrecognized. As such, it is of great importance that these patients are diagnosed as early as possible since the increased metabolic demand and blood flow associated with an epileptic insult may further compromise the brain at risk. Thus far, continuous EEG (cEEG) is the only clinical instrument that is able to detect the development of early epileptic activity. Unfortunately, cEEG is not available in most ICUs and is labor-intensive, expensive and difficult to interpret for non-trained physicians. Therefore, a more simple and prognostic accurate EEG device is highly warranted to detect seizures in an early stage so that patients might benefit from a specific and early treatment. A validation study in comatose patients with an acute neurological insult will be conducted to provide evidence that simplified Bispectral Index EEG monitoring has the potential to detect epileptic activity as reliable as its gold standard, full EEG monitoring. Thereby, BIS EEG monitoring could possibly be used to facilitate the prognostication and management of epileptic seizures in this patient cohort which could eventually improve the clinical outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patients (age ≥ 18 years) admitted to the ICU with an acute neurological insult which will be sedated/ventilated (Glasgow Coma Scale (GCS) ≤ 8).
* Ability to place BIS sensors on the forehead
* Written informed consent form has to be obtained from the patient's next of kin and has to be reconfirmed if the patient regains consciousness

Exclusion Criteria:

* Age \< 18 years
* Inability to place BIS sensors on the forehead (e.g. due to frontal decompression)
Psychosocial and Functional Factors in AxSpA

This observational, cross-sectional study aims to characterize patients with axial spondyloarthritis (AxSpA) from a biopsychosocial perspective. The study examines the relationships between psychosocial factors (such as pain catastrophizing, kinesiophobia, and fear-avoidance beliefs) and clinical indicators of disease progression, including functional limitations and disease activity. The primary objective is to identify psychosocial predictors of functionality and disease activity in AxSpA patients, which may guide more personalized therapeutic interventions. Findings could provide insights into the combined effects of physical and psychological aspects on disease management, promoting a holistic approach to AxSpA care.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years and older) diagnosed with axial spondyloarthritis (AxSpA) based on the Assessment of SpondyloArthritis International Society (ASAS) criteria.
* Experiencing symptoms of axial or peripheral involvement.
* A minimum score of 3/10 on the Numeric Pain Rating Scale (NPRS) during the initial assessment.

Exclusion Criteria:

* Individuals with other rheumatic or musculoskeletal conditions affecting the spine or joints (e.g., rheumatoid arthritis or osteoarthritis).
* History of spinal surgery or joint replacement surgery.
* Receipt of corticosteroid injections or other pharmacological treatments targeting inflammation within six weeks prior to data collection.
* Any ongoing medico-legal conflicts that could interfere with study participation.
TandemHeart to Reduce Infarct Size (TRIS Trial)

The purpose of this study is to determine if a device known as the TandemHeart® System (TandemHeart) can help limit heart damage and reduce serious complications after a certain type of heart attack (acute ST elevation anterior wall myocardial infarction \[STEMI\]) by evaluating the use of the TandemHeart system prior to a procedure called percutaneous coronary intervention (PCI)


Eligibility Criteria:
INCLUSION CRITERIA

The following is a list of general inclusion criteria. More detailed information can be found in the study protocol.

1. ≥ 18 years of age
2. Presents within 6 hours of acute MI symptoms
3. Evidence of ST elevation
4. First myocardial infarction
5. Written informed consent

EXCLUSION CRITERIA

The following is a list of general exclusion criteria. More detailed information can be found in the study protocol.

1. Contraindications to antiplatelet/anticoagulation therapy
2. History of blood disorders or active bleeding
3. Renal dysfunction or failure
4. Neurologic damage
5. Cardiogenic shock
6. History of cerebrovascular disease
7. History of transfusion reaction
8. Prior coronary artery bypass surgery
9. Participation in another trial with an investigational drug or device
10. Pregnant
A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F)

This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F)


Eligibility Criteria:
Key Inclusion Criteria:

* Homozygous for the F508del mutation (F/F)
* Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for age, sex, and height

Key Exclusion Criteria:

* Clinically significant cirrhosis with or without portal hypertension
* Lung infection with organisms associated with a more rapid decline in pulmonary status
* Solid organ or hematological transplantation

Other protocol defined Inclusion/Exclusion criteria may apply
Future Patient - Telerehabilitation of Atrial Fibrillation Patients

The idea behind this Future Patient pilot study is to explore and evaluate the feasibility of individualized telerehabilitation technologies and programs for patients with atrial fibrillation (AF).

Objective: To explore the feasibility of individualized telerehabilitation technologies and a program for patients with AF.

Outcome measures:

To evaluate two concepts for telerehabilitation programs and technologies for patients with AF in order to see how these concepts can increase self-management for patients in their rehabilitation process. The following outcome measures are in focus:

Primary outcomes:

* Usability of technologies seen from patients' and healthcare professionals' perspectives
* Test and evaluation of the contents of telerehabilitation programs

Secondary outcomes:

* Measurements of clinical data
* Patients' and relatives' expectations for and experience with participation in the telerehabilitation program
* Healthcare professionals' experience with workflows and collaboration between each other in the telerehabilitation program

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with AF
* Adults ≥ 18 years; no upper age limit
* Patients living in Skive and Viborg Municipality
* Living at home and capable of caring for him/herself
* Basic computer skills or a relative with basic computer skills

Exclusion Criteria:

* Pregnancy
* Lack of ability to cooperate
* Patient does not speak, read and understand Danish
Role of Virtual Reality Simulators in Basic Hysteroscopy Training Competence

Evaluation the efficacy of Virtual Reality simulator training in improving basic gynecological hysteroscopic skills and assess training levels in Ob/Gyn residents, as compared to others with previous hysteroscopic experience.

Diagnostic or operative hysteroscopy is one of the most common surgical intervention in gynecological surgery. In recent years, it has acquired a central role in diagnosis and treatment of a variety of uterine pathologies like fibroids, polyps and uterine malformations It is also pivotal in the management of primary or secondary infertility. Biopsy specimens are also sampled with hysteroscopy in the diagnosis of endometrial cancer.

In recent years, the technological advancements such as the use of small diameter (3,5mm) rigid hysteroscopes combined with "no touch" techniques have made hysteroscopy a commonly accepted procedure .

As a minimally invasive procedure, hysteroscopy is associated with fewer complications than traditional open surgery However, it is challenging to gain manual dexterity in hysteroscopy because of the fulcrum effect and the orientation between the two-dimensional screen and the three-dimensional uterine cavity. Other difficulties are the diminished tactile feedback and limited degrees of freedom, . Lack of proficiency in hysteroscopy can compromise patient safety by causing uterine perforation and trauma to neighboring organs. Also, pulmonary air embolisms and pulmonary edema are potential life-threatening complications.

Today it is generally accepted that the traditional apprentice-tutor model is no longer valid for training all skills necessary in Gynecological surgery and more specifically endoscopic surgery This agreement is based on the recognition that, in contrast to open surgery, endoscopic surgery demands surgical skills and psychomotor skills that should not necessarily be trained simultaneously. Increasing evidence strongly suggests that psychomotor skills must be trained earlier and outside the operating room, and several models have been proposed for this aim

Eligibility Criteria:
Inclusion Criteria:

1. Residents, assistant lecturers, lecturers, associate professors and professors in Ob/Gyn department.
2. Group A: Ob/Gyn physicians who had performed less than 50 diagnostic hysteroscopies and hysteroscopic polypectomy.
3. Group B: Ob/Gyn physicians who had performed at least 50 diagnostic hysteroscopies and hysteroscopic polypectomy.

Exclusion Criteria:

1- Physicians who had previously attended VR simulator training course
Dose-dependent Identification of Unique Biomarkers

The purpose of the research is to assess the dose-dependent impacts of the consumption of fresh pork on blood-borne metabolites (markers) following the controlled feeding of pork

Eligible participants will follow 3 randomly ordered 4-week feeding periods varying only with the consumption of 0, 3 or 6 oz of pork or a 50:50 blend of chicken and beef (6, 3 and 0 oz for respective trials to ensure similar total poultry/meat intake among trials).

Eligibility Criteria:
Inclusion Criteria:

* generally healthy (i.e., an absence of diagnosed chronic illnesses and inborn metabolic disorders)
* Age 18-65
* all races
* both sexes
* willingness to comply with the research diet requirements

Exclusion Criteria:

* special dietary needs (e.g., vegetarianism, gluten-free, etc.)
* use of medication known to influence metabolism
* smoking
* substance use
Assessment of Vertical Root Fracture Resistance of Endodontically Treated Teeth Instrumented by Single Endodontic Files

The purpose of this study is the assessment of vertical root fracture resistance of roots prepared with three different single endodontic rotary files in extracted human mandibular premolar roots.

88 human extracted mandibular premolars will be selected. Teeth will be sectioned below cementoenamel junction to get 13mm from the apex of root. Roots will then be standardized according to buccolingual and mesiodistal widths and will be examined for fracture and craze lines. The roots will then be randomly divided into 3 experimental groups and 1 control group (n=22). Group 1 will be instrumented with Hyflex EDM. Group 2 will be instrumented with F6 Sky Taper. Group 3 will be instrumented with One Shape and Group 4 will be negative control group in which no instrumentation will be done. After performing rotary instrumentation, roots will then be obturated with respective GP and sealer. Samples will then be exposed to vertical load utilizing Universal Testing Machine till fracture occur which will be recorded in Newton(N).

Eligibility Criteria:
Inclusion Criteria:

* Extracted Human mandibular premolar canals that fulfill the following criteria were used.

  * permanent teeth
  * intact and fully formed apices
  * straight and single rooted canal
  * roots having similar diameter mesiodistally(2-4mm) and buccolingually(4-6mm)

Exclusion Criteria:

* Roots having following features were excluded;

  * root caries
  * roots with multiple canals
  * previous root canal treatment done
  * signs of calcification, internal and external root resorption
  * cracks
  * fracture lines
  * C-shaped canals
  * Vertical Root Fracture
The Research of AI Assistant Gastroscope Training

In this study, we proposed a prospective study about the effectiveness of artificial intelligence system for gastroscope training in novice endoscopists. The subjects would be divided into two groups. The experimental group would be trained in painless gastroscopy with the assistance of the artificial intelligence assistant system. The artificial intelligence assistant system can prompt abnormal lesions and the parts covered by the examination (the stomach is divided into 26 parts). The control group would receive routine painless gastroscopy training without special prompts. Then we compare the gastroscopy operation score, coverage rate of blind spots in gastroscopy,check the average test score before and after training, training satisfaction, detection rate of lesions and so on between the two group.

In this study, we proposed a prospective study about the effectiveness of artificial intelligence system for gastroscope training in novice endoscopists. The subjects would be divided into two groups. The experimental group would be trained in painless gastroscopy with the assistance of the artificial intelligence assistant system. The artificial intelligence assistant system can prompt abnormal lesions and the parts covered by the examination (the stomach is divided into 26 parts). The control group would receive routine painless gastroscopy training without special prompts. Then we compare the gastroscopy operation score, coverage rate of blind spots in gastroscopy,check the average test score before and after training, training satisfaction, detection rate of lesions and so on between the two group.

Eligibility Criteria:
Novice endoscopists：

Inclusion Criteria:

1. Males or females who are over 18 years old;
2. After qualified medical education and obtained the Certificate of Chinese medical practitioner;

Exclusion Criterial:

1. A doctor who has already been trained in gastroenteroscopy;
2. Doctors without qualified medical education and didn't obtaine the Certificate of Chinese medical practitioner;
3. The researcher believes that the subjects are not suitable for participating in clinical trials.