cyrilzakka/clinical-trials huggingface dataset:
COVID-19 in the Swedish ICU-cohort: Risk Factors of Critical Care Admission and Intensive Care Mortality

The Corona virus disease 2019 (COVID-19) pandemic is currently involving all parts of the world. Several risk factors for critical illness and death from the disease have been proposed. However, the observed associations between different comorbidities and chronic medications have not fully been related to the frequencies of the same comorbidities and chronic medications in age- and sex-matched controls from the general population. This is important since some of the proposed risk factors are very common in the aged who, by age alone, are more prone to a more severe course of the disease.

By combining several registries, we will compare, on several comorbidities such as hypertension and diabetes and several medications such as immunosuppressant drugs and Angiotensin Converting Enzyme (ACE)-inhibitors, the first 2000 cases of COVID-19 patients receiving critical care in Sweden to a set 8000 age- and sex-matched controls.

The COVID-19 pandemic is currently involving all parts of the world. Several risk factors for critical illness and death from the disease have been proposed. However, the observed associations between different comorbidities and chronic medications have not fully been related to the frequencies of the same comorbidities and chronic medications in age- and sex-matched controls from the general population. This is important since some of the proposed risk factors are very common in the aged who, by age alone, are more prone to a more severe course of the disease.

By combining several registries, we will compare, on several comorbidities such as hypertension and diabetes and several medications such as immunosuppressant drugs and ACE-inhibitors, the first 2000 cases of COVID-19 patients receiving critical care in Sweden to a set 8000 age- and sex-matched controls.

Data sources:

Registries of the Swedish board of Health and wellfare:

1. The patient registry containing information including diagnostic codes from all specialized Healthcare contacts in Sweden. Reporting i governed by law.
2. The Swedish Prescribed Drug Register to which all dispensations from pharmacies of prescribed drugs are reported.

Statistics Sweden is the agency responsible for the official population statistics of Sweden. They will draw our controls from the Registry of the total population.

The Swedish Intensive Care Registry (SIR) contains all intensive care episodes in Sweden. They have information on Intensive Care (ICU) admission, diagnoses, interventions and outcomes.

The study design is combined prospective ond retrospective. The data is prospectively collected to the registries but the study protocol is retrospectively designed.

Eligibility Criteria:
Inclusion Criteria:

-Included in the SIR with COVID-19 any time until data acquisition

Exclusion Criteria:

-Age below 18 years.
Testing Pediatric Rheumatology Diagnostic Decision Support in Clinical Use

This study is designed to test the helpfulness of a diagnostic tool, SimulConsult, when clinicians are diagnosing pediatric rheumatic diseases. Trainees and nurse practitioners will use the software or not use it, and their differential diagnoses will be compared to those of attending physicians in the same clinical encounter, and then to definitive diagnoses weeks later after testing, if one is reached.

The study aims to assess improvement in the clinical performance of trainees evaluating patients with a suspected rheumatologic disorder. The Intervention is the use of Diagnostic Decision Support Software (DDSS) already available as a Boston Children's Hospital resource.

* Main objective: To assess if the use of the DDSS by trainees and nurse practitioners can improve their diagnostic performance in developing a differential diagnosis and plan in real clinical use. (Studies have shown in prior research that the use of the DDSS does so for case vignettes, lowering diagnostic errors of trainees by 75%). The study will compare how closely the differential diagnosis and plan of the trainees and nurse practitioners approximate those of their senior Pediatric Rheumatology attending physician colleagues.
* Secondary objective: To assess how frequently the differential diagnosis of the trainees and nurse practitioners includes the definitive diagnosis by doing a manual chart review weeks after the visit. (Studies have shown in prior research that if the definitive diagnosis is in the initial differential diagnosis, the right tests get ordered, and diagnostic errors are avoided.)

The design is a parallel one, comparing subjects (trainees and nurse practitioners) using the DDSS (Intervention Arm) to subjects who do not use the DDSS (Control Arm). In both study arms, subjects may use all other traditional resources. Arm assignment will be by patient case rather than trainee / nurse practitioner to reduce variation due to each subject's different capabilities (years of training and familiarity with pediatric rheumatology).

Eligibility Criteria:
The subjects are trainees (rheumatology and rotating fellows) and nurse practitioners, not patients. The Attendings participate in their supervisory role, and their clinical judgments are recorded as a preliminary "gold standard", but they are not research subjects.

* Trainees seeing new pediatric patients with a potential rheumatologic disorder are eligible. They will be drawn from the pool of Rheumatology fellows (3), Allergy/Immunology fellows (6), rotating pediatric and occasional adult residents (1 - 2) per month)
* Nurse practitioners in Rheumatology (2).
* Rheumatology Attendings for these new patient visits will also be asked to participate but will be supervisory participants in the study, not subjects.

We anticipate 15 trainees plus nurse practitioners will participate. There are no exclusion criteria, and we do not anticipate screen failures; however, trainees and nurse practitioners may decline to participate for individual patients or the entire study.
MELT - MRI Evaluation of Lymphoma Treatment

Patients who are newly diagnosed with Hodgkin's lymphoma will undergo disease staging at diagnosis and initial treatment response assessment. At each time point (initial staging and treatment response assessment) in addition to standard imaging investigations (PET CT, Chest CT, anatomical MRI of the abdomen and pelvis and abdominal USS), patients will undergo an extended MRI scan.

The trial will be a single centre cohort study in patients newly diagnosed with Hodgkin's lymphoma undergoing disease staging at diagnosis and initial treatment response assessment. At each time point (initial staging and treatment response assessment) in addition to standard imaging investigations (PET CT, Chest CT, anatomical MRI of the abdomen and pelvis and abdominal USS), patients will undergo advanced anatomical and functional MRI sequences.

Eligibility Criteria:
Inclusion Criteria:

* Aged 5 to 20 years (inclusive) with participant and parent/guardian informed consent
* Histologically confirmed first presentation of Hodgkin's Lymphoma
* Either entered into the Euronet PHL-C1 trial or LP1 trials OR not formally entered into the Euronet trials but treated on the chemotherapy regimens of the Euronet trials for classical and lymphocyte predominant Hodgkin Lymphoma

Exclusion Criteria:

* Contraindications to MRI (e.g. pacemaker)
* Previous malignancy or previous chemotherapy or radiotherapy treatment for malignancy
* Pregnancy or nursing
Patient-reported and Clinical Outcomes in Adults With Relapsed or Refractory Hodgkin's Lymphoma Receiving Brentuximab Vedotin

The goal of this is study is focusing on assessment of patient-reported outcomes in terms of quality of life (QoL) and symptom profile as well on evaluation of clinical efficacy and safety of BV in patients with refractory/resistant HL in a real-world setting.

Information on QoL in patients with refractory/relapsed HL treated with BV is quite limited till now. Moreover, PRO data in patients treated for refractory/relapsed HL with BV, including long-term effects of BV on patient's QoL in a real-world setting are lacking.

The goal of this is study is focusing on assessment of patient-reported outcomes in terms of QoL and symptom profileas well on evaluation of clinical efficacy and safety of BV in patients with refractory/resistant HL in a real-world setting.

For PROs assessment QoL and symptom data will be received from patients' reports before and at 3, 6, 9, 12 months after BV treatment start and in 3 months at follow-up (15 months after base-line). The maximum duration of PRO monitoring - 15 months. To evaluate PROs the followings tools will be used: RAND SF-36 for quality of life assessment, Edmonton Symptom Assessment System (ESAS-R) for symptom assessment and Patient Global Impression of Change (PGIC) for assessment of a patient's belief about the effect of treatment.

For evaluation of response rates, duration of response, PFS and for analysis of AEs/SAEs during BV treatment the clinical data will be collected from health records at base-line, at 3, 6, 9, 12 months after BV treatment start and at 15 months of follow-up or till the last dose of BV.

No randomization and stratification will be applied. The analysis of primary (PROs assessment) and secondary outcomes (clinical outcomes) will be provided in the total patient population (n=70) and in two subgroups. The subgroups of interest will be: patients with relapsed or refractory HL who are not candidates for ASCT with prescribed treatment with BV as ≥2nd line therapy, and patients with relapse after ASCT with prescribed treatment with BV.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with confirmed diagnosis of relapsed or refractory HL
* At least 18 years of age at time of BV treatment decision
* Patients with relapsed or refractory HL who are not candidates for ASCT with prescribed treatment with BV as ≥2nd line therapy, and patients with relapse after ASCT with prescribed treatment with BV
* Patients with given informed consent
* Patients who are capable to fill out questionnaires
* Patients with expected life duration of at least 6 months

Exclusion Criteria:

* Patients enrolled in clinical trials
* Patients with contraindications to BV in accordance with instruction for use
Phase I/II CT 2106 and 5-FU/FA in Colorectal Cancer

CT-2106, a camptothecin (CPT) conjugate, is a new generation of topoisomerase I inhibitors designed to deliver higher, more effective chemotherapy to tumor tissue with less toxicity to normal tissues. The objective of this study is to determine the dose limiting toxicities, safety profile and antitumor activity of CT-2016 in combination with 5-FU and folic acid for the treatment of colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven metastatic colorectal adenocarcinoma, failing one prior treatment containing oxaliplatin plus 5-FU/FA
* At least one measurable lesion according to RECIST criteria for both Phase I and II
* ECOG performance status 0 or 1
* Adequate hematologic, renal and hepatic function
* Wash out period of at least 4 weeks from surgery, 4 weeks from radiotherapy

Exclusion Criteria:

* Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix.
* Pregnant or lactating patients
* Prior treatment with camptothecins
* Presence or history of CNS metastasis or carcinomatous leptomeningitis
* Current active infection per investigator assessment
* Unresolved bowel obstruction or partial obstruction, uncontrolled Crohn's disease or ulcerative colitis
* Current history of chronic diarrhea greater than or equal to grade 1 (CTCAE version 3)
The Prevalence of the Aortic to Radial Pressure Gradient in States of Shock, Outside the Context of Cardiac Surgery, a Prospective Study

First described in cardiac surgery, the aortic to radial pressure gradient (ATRAP) is the cause of an underestimation of the aortic pressure with a measure assumed with a radial catheter, and he can concert 1 of 3rd patients. The risks factor well known are small height, previous hypertension, long and difficult surgery, radial artery diameter less than 1.8mm.

The ATRAP definition is a pressure difference between radial and femoral (same of the aortic pressure) pressure of 25mmHg on the systolic pressure, or a pressure difference on the mean pressure of 10mmHg, both measures realised by arterial canulation, and with a duration superior than 5 minutes.

If this gradient appears in pathophysiological specifics situations, there is a risk of inappropriate administration of vasopressors, with more hospitalisation days, more side effect of vasopressors like an augmentation of myocardial work.

The ATRAP is documented in septic shock with a prevalence between 21% and 27%. The ATRAP can appear in shocks, moreover with doses of equivalent norepinephrine of 0.5 µg/kg/min who is use for the definition of refractive shock, the difference between the two pressure is higher if the dose of equivalent norepinephrine is higher than 1µg/kg/min. But the prevalence and risks factors are barely unknowns in this situation.

Most of the time, a radial arterial catheter is used for hemodynamic monitoring for his simplicity of utilisation and the lows complications associated. Some medical teams in cardiac surgeries, or in intensive care unit (ICU) for the management of shocks used often radial and femoral arterial catheter. It seems there is no at risk for the utilisation of a radial and femoral arterial canulation.

Out of the situation of cardiac surgery, there is a lack of information of the ATRAP, the objective of the study is to evaluate the prevalence of the ATRAP in shock, out of the situation of cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* age superior or equal 18 years
* Vasopressors support superior or equal 0.5 µg/kg/min of equivalent norepinephrine
* Invasive monitoring of blood pressure with a radial arterial catheter and a femoral arterial catheter decided by de physician
* Beginning of the shock less than 48 hours.
* Consent

Exclusion Criteria:

* perioperative of cardiac surgery (between the beginning of the surgery and 7 days after)
* pregnant woman or breast-feeding
* Major person under protection
* Person with privation of liberty by a justice decision, or an administrative decision
Clinical and Biochemical Evaluation of the Efficacy of Non-Surgical Treatment Approaches in the Treatment of Peri-implantitis

Peri-implantitis is a pathological condition associated with plaque that develops around dental implants, characterized by inflammation and progressive bone loss in the peri-implant area. Bleeding on probing, suppuration, increased pathological pocket depths and/or mucosal recessions are seen with radiographic bone loss in peri-implantitis. When evaluated histologically, the lesion extends to the apical part of the pocket epithelium and contains a large amount of plasma cells, macrophages and neutrophils. In the Peri-implant crevicular fluid analysis, which is one of the most important parameters that enable the biochemical and immunological evaluation of the inflammatory state in the peri-implant region, information about the current inflammatory situation can be obtained by evaluating the content of an osmotic inflammatory exudate originating from the vessels in the gingival plexus. Many surgical and non-surgical methods have been proposed for the treatment of peri-implantitis. Mechanical surface debridement, laser application and air abrasives are a part of non-surgical treatment of peri-implantitis. In this study, we examined the effectiveness of diode laser in addition to mechanical debridement with titanium curettes. In our study, we aimed to compare these two treatments biochemically by determining the changes in interleukin-1β, Interleukin-10, Interleukin-17, RANKL, osteoprotegerin, TWEAK and sclerostin biomarkers in Peri-implant crevicular fluid and clinically.

Primary outcome measures (probing depth as clinical parameter) and secondary outcome measures ( collection of gingival crevicular fluid, gingival bleeding time index, gingival index, plaque index and clinical attachment level) asre recorded in baseline, third and sixth month. The change between these parameters is observed.

Eligibility Criteria:
Inclusion Criteria:

* Presence of 5mm or more peri-implant pockets
* Not having periodontal treatment in the last 3 months,
* The informed consent form must be approved,
* At least 18 years old.

Exclusion Criteria:

* Presence of systemic disease,
* Smoking,
* Regular use of non-steroidal anti inflammatory drugs,
* Having been treated with antibiotics in the last 3 months,
* Individuals in need of pre-treatment antibiotic prophylaxis,
* Pregnancy and lactation,
* Not approving the informed consent form,
* Patients with known allergies.
Predictive Values of Presepsin Levels in ASciteS in Patients With Chronic Liver Failure

The investigators aim to study the predictive value of presepsin in ascites in newly admitted patients with chronic liver failure.

Presepsin is a plasmatic cleaved fragment of CD14. CD14 is a toll like receptor who has the role to identify certain lipopolysaccharides on the surface of bacteria (aerobes and anaerobes), thus promoting an inflammatory response.

A study of 153 patients with liver cirrhosis published by a team of investigators from Iasi, Romania, has proven an useful role of plasma presepsin in early diagnosis of infections in patients in acute on chronic liver failure.

In addition, plasma presepsin has been proposed as an independent predictor of mortality in patients with decompensated liver cirrhosis, without concomitant bacterial infections.

Question to be answered by this study The investigators aim to evaluate the predictive role of ascites presepsin in patients with chronic liver failure.

Hypothesis Presepsin levels in ascites may have a prognostic role in patients with ascites and chronic liver failure.

Eligibility Criteria:
Inclusion Criteria:

* patient with ascites and chronic liver failure
* no contraindications and technical possibility to perform diagnostic paracentesis
* age above 18 years old
* informed consent

Exclusion Criteria:

* contraindications to paracentesis or technical impossibility to perform paracentesis
* absence of informed consent
Effect of Cold Application and Vibration in Reducing Pain During Vaccination in Children

The study was designed as a randomized controlled experimental research with the purpose of determining the effect of using Cold Application and Vibration in reducing pain during routine vaccination in children.

In the literature, it is stated that nurses should use pharmacological and non-pharmacological methods in pain and anxiety management in painful procedures. Evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on pain.In light of this information, this study aimed to examine the effect of by using Cold Application and Vibration in reducing pain during routine vaccination in children. Cold Application and Vibration will be done with BUZZY.

This study is a prospective, randomized and controlled trial. Children aged 13 years who required routine vaccination were divided into three groups; placed under arm Buzzy, placed in standard Buzzy, and Control. Data were obtained through face-to-face interviews with the children, their parents, and the observer before and after the procedure. The children's pain levels were assessed and reported by the parents and observers and the children themselves who selfreported using Wong-Baker FACES.

The study population consisted of the children's during routine vaccination in children aged 13 years. Sample of the study consisted of a total of 90 children who met the sample selection criteria and were selected via randomization method.

Children were randomized into three groups; placed under arm Buzzy (n:30), placed in standard Buzzy (n:30), and Control (n:30). Data were collected using the Interview and Observation Form and Wong-Baker FACES Pain Rating Scale.

Eligibility Criteria:
Inclusion Criteria:

* Children the ages of 13 years (planned to be included in the vaccination calendar program),
* Volunteering of the child and parent to participate in the study,
* Healthy children,
* Vaccination should be done by the same nurse,

Exclusion Criteria:

* The child has any acute or chronic disease,
* The child has a mental disability, vision, speech or communication problems,
* The parent has hearing, vision or verbal communication difficulties,
* The child used analgesics in the last 6 hours,
* Infection, disruption of skin integrity and rash in the area where theapplication will be made,
* Exclusion criteria were that the parent or child wanted to leave the study at any point.
Splenectomy as a Treatment for Patient With Relapsed Haemophagocytic Lymphohistiocytosis of Unknown Etiology

To evaluate the clinical value of splenectomy as a treatment for relapsed haemophagocytic lymphohistiocytosis (HLH) in patient with unknown etiology.


Eligibility Criteria:
Inclusion Criteria:

1. Patients were older than 14 years of age
2. Diagnosed as Hemophagocytic Lymphohistiocytosis (HLH) according to HLH-2004.
3. patients were excluded with infection, rheumatic and immunologic diseases, malignant tumors (especially lymphoma), and primary HLH.
4. Informed consent

Exclusion Criteria:

1. Pregnancy or lactating Women
2. Active bleeding of the internal organs
3. Uncontrollable infection
4. Contraindication of splenectomy
5. Participate in other clinical research at the same time
Efficacy of Local Anesthetic and Ozone Injection in Patients With Myofascial Pain Syndrome

In this study, the investigators planned to compare local anesthetic injection added to stretching exercise, ozone injection treatment added to stretching exercise, and only stretching exercise in patients with upper trapezius muscle myofascial pain syndrome.

The investigators will recruit 72 patients with at least one trigger point in the upper trapezius muscles and a clinically confirmed diagnosis of myofascial pain syndrome (MAS) (according to Travell-Simons' criteria) admitted to the physical medicine and rehabilitation outpatient clinic.

Age, gender, occupation, medications, duration of diagnosis, body mass index, comorbidity, functional status and pain of these patients will be questioned. Patients will be randomly divided into three groups. A total of 3 consecutive weeks of treatment were planned.

Eligibility Criteria:
Inclusion Criteria:

* With at least one trigger point in the upper trapezius muscles and a clinically confirmed diagnosis of MPS

Exclusion Criteria:

* Presence of any cervical radiculopathy or a history of degenerative conditions
* Presence of any cervical surgery or trauma in the past year,
* History of injection for the treatment of MAS in the last 6 months,
* Cognitive disorder,
* Rheumatological disease, fibromyalgia,
* History of metabolic diseases such as hypothyroidism and diabetes mellitus