cyrilzakka/clinical-trials huggingface dataset:
Intra Arterial (IA) Steroids Infusion for Hepatic Acute Hepatic Graft Versus Host Disease (aGVHD)

Post allogeneic hematopoietic stem cell transplantation (HSCT) patients with steroid resistant acute GVHD localised to the liver will receive 24 hours continuous intra-arterial infusion of methylprednisolone.

The study population will include 30 patients with SR AGVHD having an index of B, C, or D on the IBMTR severity index localized to the liver.

Standard treatment for SR AGVHD includes: IV cyclosporine or tacrolimus with adjusted doses depending on serum levels and methylprednisolone or prednisone 2 mg/kg/d. This treatment may be continued during the study period although steroid taper down should be attempted if clinically possible.

GVHD diagnosis will be based upon clinical criteria and biopsy (if needed) from an involved organ. GVHD will be graded according to the International Bone Marrow Transplantation Registry (IBMTR) severity index.

Intra-arterial treatment should be given in less than 72h from completion of inclusion criteria.

Partially responding or non-responding patients may receive a second treatment within 14 days of the initial intra-arterial treatment, at the discretion of the treating physician.

Definitions

Hepatic response:

* Initial response - the day in which bilirubin level began to decrease.
* Partial response 75 - the day in which bilirubin level decreased below 75% of basal level.
* Partial response 50 - the day in which bilirubin level decreased below 50% of basal level.
* Partial response 25 - the day in which bilirubin level decreased below 25% of basal level.
* Complete response - the day in which bilirubin level decreased to normal level.

Eligibility Criteria:
Inclusion Criteria:

* Recipient of allogeneic stem cell transplantation.
* Age\>18 years.
* Post stem cells transplant \<100 days.
* AGVHD of liver, IBMTR index B, C, D.
* Resistant AGVHD - Patients will be eligible for inclusion if they developed grade B-D AGVHD with progression after 3 days standard treatment OR unresponsive to at least 7 days standard treatment OR incomplete response to standard treatment after 14 days.
* Has received no 1st line treatment for steroid refractory AGVHD.
* Signed a written informed consent

Exclusion Criteria:

* Not fulfilling any of the inclusion criteria.
* Active life-threatening infection.
* Inability to comply with study requirements.
* Inability to give informed consent.
* Contraindication to arterial catheterization (uncorrectable coagulopathy, severe allergic reaction to contrast material or others).
* Inability to give the first Intra-arterial treatment in less than 72h from completion of inclusion criteria
* An IBMTR index ≤ A.
* Refractory skin AGVHD or severe diarrhea..
* Pregnant or breast-feeding female or childbearing potential.
* Known to be HIV positive.
* Has been diagnosed with veno-occlusive disease.
* Has been diagnosed with multi organ failure.
* Known renal failure eGFR \<30
Glucose Metabolism Disorders and Metabolic Syndrome Before and After Primary Hip and Knee Replacement

Osteoarthritis patients undergoing primary hip and knee replacement are followed-up and changes in their glucose metabolism and other metabolic parameters (obesity, cholesterol levels) are examined. Persistent postoperative pain is examined as secondary outcome.

Glucose metabolism disorders (diabetes and pre-diabetes) and metabolic syndrome are common in joint replacement recipients. Improved physical activity following joint replacement could lead to better glucose control in diabetes and ameliorate impaired glucose and cholesterol levels. In this study patients previously recruited to "Perioperative Hyperglycaemia in Primary Total Hip and Knee Replacement" study are being followed-up for one year in order to analyze if joint replacements have an effect on these metabolic abnormalities. In addition, the effect of glucose metabolism disorders on occurrence of persistent pain after surgery is analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Primary hip and knee replacement for osteoarthritis
* Enrolled previously into study NCT01021826

Exclusion Criteria:

* Arthritis other than osteoarthritis (based on study NCT01021826)
* Medication affecting glucose metabolism (excl. antidiabetic agents) (based on study NTC01021826)
* Died before follow-up phase
* Did not undergo the planned hip or knee replacement
SABR for Renal Tumors

Renal Cell Carcinoma (RCC) is the most common type of kidney cancer. The usual treatment for this type of cancer is surgery. Considering the most common patients are an average age of 65 and some are not suitable candiates for surgery, there is great interest in non-surgical alternatives for kidney cancer treatments. This study will investigate the use of Stereotactic Ablative Radiosurgery (SABR) for renal tumors. SABR is a non-invasive alternative, which involves delivery of high doses of radiation to the target, while minimizing the risk of injury to the surrounding organs. Patients will be seen before and end of treatmetn and will be followed at 4 month intervals for up to 2 years. During the follow ups, patients will be asked to complete a quality of life questionnaire and will have standard of care imaging.


Eligibility Criteria:
Inclusion Criteria:

* Solid Kidney Mass (primary RCC or metastasis) amenable to SABR ≤6cm
* Histological or radiological diagnosis of renal tumor
* Inoperable: High risk for surgery or declined surgery
* ECOG performance status of 0-3

Exclusion Criteria:

* ≥5 active metastases
* Sysstemic therapy (except endocrine therapy) wthin 6 days prior to SABR
* Prior abdominal radiotherapy with fields overlap resulting in excessive doses to the involved kidney
* Patients with end stage renal failure \> 4(KDOQI guidelines)
* Familial Syndrome: Von Hippel-Lindau disease, Polycystic Kidney Disease, Hereditary Papillary RCC or Tuber Sclerosis
Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients

The syndrome of obstructive sleep apnea (OSAS) is a public health problem that affects 2 to 4% of the general population. The patients with OSAS frequently complain of intolerance to exercise muscle fatigue and a significant even if they have not been fully characterized in the literature.

The anomalies in the exercise of patients with OSAS could be due to metabolic changes (insulin resistance and oxidative stress) and cardiovascular (impaired vascular reactivity).

Our goal is both to determine whether these anomalies exist in patients with OSAS not obese, consider their relationship with the alteration of exercise capacity, and their reversibility in conventional PPC or by using the effects of physical activity regular.In this study Objectives: To establish whether the metabolic and vascular abnormalities associated with OSAS are associated with decreased parameters of physical fitness in relation to witnesses matched for age, sex and body mass index. Determine the effects of a re-training exercise on these parameters compared to the reference treatment, continuous positive pressure.

Main objective: To compare the exercise capacity of OSAS patients compared with that of witnesses matched for age, sex and body mass index.

Secondary objectives: To compare the effect of conventional treatment by continuous positive pressure (CPP) on cardiovascular and metabolic abnormalities of OSAS, with a therapeutic modality most original, physical activity.

Methodology: Test physiopathological parallel group, controlled, randomized.

Study type : Physiopathology trial Study design : Prospective randomized controled trial

Expected Total Enrollment : 45 patients + 15 control subjects

Tested treatment : Physical exercise program (45 minutes, 3 times a week) Reference treatment : continuous positive airway pressure Treatment duration : 12 weeks (3 months) Total study duration : 2 years

Eligibility Criteria:
Inclusion Criteria:

* Ages Eligible for Study : 18 Years and above
* Genders Eligible for Study: Both
* Non obese : body mass index (BMI \< 30 kg/m2)
* Sedentary subjects : less physical activity than 30 minutes 3 time a week
* and VOORIPS physical activity level questionnaire score \< 9.

Obstructive sleep apnea syndrome (OSAS) patients :

* Recently diagnosed (\< 3 months)
* AHI \> 30 / hour (polysomnographic monitoring measurement)

Exclusion Criteria:

* Excessive daytime sleepiness (Epworth score \> 12)
* Cardiovascular pathology (except controlled hypertension)
* Pathology interacting with physical activity
* Diabetes (known or treated)
* Other participation to a clinical trial at the same
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer

This study will assess the efficacy and safety of adding Herceptin to a paclitaxel-containing regimen followed by cyclophosphamide/methotrexate/fluorouracil (CMF) chemotherapy in women with locally advanced breast cancer and HER2/c-erbB-2 gene amplification. In a parallel observational study patients with HER2-negative disease will receive the same chemotherapy without Herceptin.


Eligibility Criteria:
Inclusion Criteria:

* female patients, \>=18 years of age, with locally advanced breast cancer.

Exclusion Criteria:

* previous therapy for any invasive malignancy.
Research Project About Psychological Strain, Quality of Life and Emotional Awareness in Patients With Tinnitus

Validation of PRISM (Pictorial Representation of Illness and Self Measure) as a assessment of quality of life and suffering in patients with tinnitus.

Association between experiencing, verbalizing and regulating emotions and perceived tinnitus.

Correlation analysis are used to search for connections between the subjective behavioral outcomes mentioned above and the objective EEG-patterns.

Validation of PRISM (Pictorial Representation of Illness and Self Measure). Assessment of quality of life and suffering in patients with tinnitus in an observational study using different questionnaires. (THI, TF, TBF-12, BDI, BAI, SF-36).

THI - Tinnitus Handicap Inventory

TF - Tinnitus Questionnaire after Goebel and Hiller

TBF-12 - Tinnitus Impairment Questionnaire

BDI - Beck Depression Inventory

BAI - Beck Anxiety Inventory

SF-36 - Short Form 36 Health Survey Questionnaire

Association between experiencing, verbalizing and regulating emotions and perceived tinnitus using the TAS-20 (20-Item Toronto Alexithymia Scale) and the above mentioned questionnaires.

EEG-studies on the spontaneous brain activity of individuals affected by tinnitus consistently report differences in the composition of the EEG-frequency spectrum between individuals with tinnitus and healthy controls. Furthermore it has been shown that not only the auditory cortex but other regions of the brain are involved in the perception of the chronic ear noise as well. Among them is the limbic system which is associated with the emotional processing of the human brain.

Correlation analysis are used to search for connections between the subjective behavioral outcomes mentioned above and the objective EEG-patterns. Aim of the current study is to provide conclusive models of associated assessments of the psychological strain end emotional stress of individuals suffering from tinnitus and objective EEG-analysis.

Eligibility Criteria:
Inclusion criteria:

* all patients older than 18 years with tinnitus who want to participate the investigation during the period of data acquisition

Exclusion criteria:

* patients younger than 18 years,
* insufficient knowledge of the German language.
The Study Focuses on the Release of the Iliolumbar Ligament Using a Pumped Technique, Addressing Its Tightness Caused by Excessive Anterior Pelvic Tilt During Pregnancy. This Condition Often Results in Low Back Pain and Mechanical Dysfunction of the Lumbar and Sacroiliac Regions.

The iliolumbar ligament, one of the sacroiliac ligaments, has been identified in recent research as a contributor to low back pain when tight. During pregnancy, hormonal changes and postural changes can cause this ligament to tighten, leading to pain. Releasing the iliolumbar ligament can reduce low back pain and restore normal mechanical function.

Group A (Control group) It will be consisted of postnatal women and will be treated by hot packs for 20 minutes three times per week for 8 weeks.

Group B (study group) the participant will treated by hot packs for 20 min in additional to pumping technique for iliolumbar ligament release for 30 min. 3 times per week for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

1- the women are delivery within 3 months. 3- Their BMI must be less than 30 Kg\\m 2 . 4- Its included primipara or multipara. 5- Its included be normal vaginal labor delivery or caesarian section.

Exclusion Criteria:

1. Clinical diagnosis by Lumbar disc prolapse.
2. Clinical diagnosis by Lumbar spondylolysis and spondlysis.
3. Clinical diagnosis by back trauma or fracture.
4. Clinical diagnosis by Lumbar canal stenosis.
5. Clinical diagnosis by Rheumatoid arthritis.
6. Clinical diagnosis by Malignancy.
7. Clinical diagnosis by any deformity for low limb.
8. Clinical diagnosis by Scoliosis.
9. Taking analgesic drugs.
10. Clinical diagnosis by Deep vein thrombosis
Evaluation of DiaSorin LIAISON® PTX3 (Long Pentraxin 3) Assay in Patients With Pneumonia

LIAISON® PTX3 is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of Long Pentraxin 3 (PTX3) in human plasma samples.

LIAISON® PTX3, in conjunction with clinical evaluation and other laboratory findings, may serve as an aid in the determination of disease severity and prognosis of patients with community-acquired (CAP) and hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP).

Long Pentraxin 3 (PTX3) is an essential protein of innate immunity, produced by myeloid cells, endothelial cells and respiratory epithelial cells, and involved in resistance to selected pathogens and in inflammation. In different pathological conditions (infections of bacterial and viral origin, sepsis, and cardiovascular diseases) and in patients requiring admission to intensive care units (ICUs), PTX3 was detected in high concentrations in the circulation and was associated with disease severity and mortality.

PTX3 plasma concentration was found to be an independent prognostic indicator of short-term mortality (28 days) in hospitalized patients with Coronavirus Disease 2019 (COVID- 19) and higher PTX3 levels were found in ICU patients compared to ward patients. Moreover, PTX3 significantly correlated with the inflammatory molecules C-reactive protein (CRP), procalcitonin (PCT), and interleukin (IL)-6.

Given the association between PTX3 and inflammatory conditions, especially in the context of lung infections, the study aims to investigate the potential of PTX3 to be used as a severity marker and a prognostic predictor for outcome in patients with community-acquired (CAP) and hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP).

Eligibility Criteria:
Inclusion Criteria:

* Subjects willing and able to sign the approved Informed Consent form in accordance with international and national regulations
* Patients diagnosed with pneumonia, either CAP, HAP, VAP
* Collection of plasma samples within 24 hours from pneumonia diagnosis (for CAP diagnosis is usually made at ED presentation and for HAP and VAP diagnosis is made during hospital stay)
* K2 EDTA plasma samples dedicated to the study have a minimum volume of 3 mL

Exclusion Criteria:

* Patients who are currently pregnant
* Samples collected and/or stored in an inappropriate way
Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion

The effects colchicine administration for acute pericardial effusion after radiofrequency catheter ablation (RFCA) of atrial fibrillation on the recurrences of arrhythmia.

RFCA was started as a rhythm control of atrial fibrillation about 10 years before and the superiority of RFCA to medical treatment has been continuously reporting, so RFCA is globally performed nowadays. Acute pericardial effusion could occur during RFCA as complication, that might be developed to cardiac tamponade needed immediate pericardiocentesis. The inflammation developed after pericardiocentesis might be associated with the recurrences of atrial fibrillation, it could be presumed by the frequent occurrence of atrial fibrillation after open-heart surgery. The inflammation can be suppressed by administration of colchicine and the effects of colchicine have been proven to decrease the development of atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

* Patients needed to pericardiocentesis during RFCA for paroxysmal or persistent atrial fibrillation.

Exclusion Criteria:

* Hypersensitivity on Colchicine
* The existence of intra-cardiac thrombus on trans-esophageal echocardiography
* Pregnancy
Observational Study of NovoNorm® in Subjects With Diabetes

This study is conducted in Asia. The aim of this study is to review the safety and efficacy of Novonorm® (repaglinide) in post-marketing use.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
Individual Structured Therapy in Early Premature Infants at the Neonatal Intensive Care Unit

In this study, investigators aimed to apply an individual structured therapy protocol within the framework of neurodevelopmental therapy principles in early premature infants hospitalized in the neonatal intensive care unit and to examine its effect on the motor development of infants.

The study is planned to include 20 early premature (\<34 weeks) newborns hospitalised in the neonatal intensive care unit. The babies will be divided into two groups as therapy group and control group. Internet-based randomisation system will be used to determine the groups according to their risk levels. The risk levels will be determined according to the guidelines of the Turkish Neonatology Association.

Sterile gowns, masks and bonnets will be used during assessment and therapy to reduce the risk of infection in terms of the safety of the babies, and small lids will be opened so that the physiotherapist's hand can enter to maintain the temperature and oxygen balance in the incubator.

Therapy group: In addition to routine care, they will be arranged according to the needs of the baby in the form of positioning, hand contacts, passive and active movement of the arms and legs for the development of movement, sensory stimuli around the mouth for oral motor organisation. Neurodevelopmental-based application will be applied three days a week, once a day for 10-15 minutes, from the 34th week until 37th week when vital signs are stable.

Control group: They will be monitored by performing routine care and positioning.

Eligibility Criteria:
Inclusion criteria

1. Hospitalised in the neonatal intensive care unit,
2. Born before 34 weeks of gestation
3. medium and low-risk babies
4. Newborns who were approved by their families to participate in the study Exclusion criteria

1. Diagnosed neurological, neuromuscular or genetic disease 2. Congenital anomalies 3. Newborns whose parents did not consent to participate in the study
Community-based Personalized Care and QOL

A pragmatic randomized trial to evaluate the impact of an integrated patient experience and outcome measurement system supported by citizens, caregivers and community through eHealth technology.

The primary research question is: What is the effectiveness of the WECCC approach on quality of life in people aged 65 and older or who self-identify as disabled compared to people not receiving the Health TAPESTRY program?

Secondary research questions include:

1. what is the feasibility of obtaining study measures through routinely collected program participant data and what design adjustments are needed to balance pragmatism and high quality data collection?
2. What are the analytic approaches to be developed to aggregate data from individual participants into meaningful units (e.g. care-team level, organizational level, social network, and geographic area) to inform ongoing adaptation of the components of the intervention?
3. what are the perceptions of knowledge users on the usefulness of comparative effectiveness pragmatic trial evidence?

The project involves using administrative data from the ICES to create outcome measures and feedback systems for communities, and the INSPIRE PHC Unit for expertise in health system integration, care in the community, and knowledge translation.

Inclusion criteria: Seniors (65+) and people who self-identify as having a functional disability. Pilot study sites: 7 municipalities and the city of Windsor in Windsor-Essex County in Ontario. The combined total eligible population in all 8 sites is about 60,000 people, from which a minimum sample of 3000 registered patients and 1000 registered caregivers will be drawn

In Year 1, planned enrolment includes a minimum of 1100 intervention clients from all recruitment methods in the care model intervention, with similar numbers of control and intention to treat clients.

The primary outcomes are quality of life (QOL); perceived health; experience of care, and perceived social connection.

The primary outcomes for caregivers will be quality of life; perceived burden; caregiver perceptions of care; and perceived social connection.

Secondary outcomes for both will include goal attainment, distress management, symptom management, places of care, and health care utilization and costs. In terms of health equity, the investigators will measure the difference between the average/median population quality of life and cost outcomes compared to patients at the bottom income quartiles stratified by risk level. At a systems level, algorithms will be developed and applied to the data collected from participants to provide aggregate organization and system-level reports, co-designed with end users to support them as learning organizations.

Eligibility Criteria:
Inclusion Criteria:

Individuals who:

1. are 65 years of age and over
2. have a long-term disability or one or more chronic diseases
3. able to communicate in English OR can provide a formal or informal translator willing to facilitate the participant's involvement

Exclusion Criteria:

Individuals not meeting above criteria