cyrilzakka/clinical-trials huggingface dataset:
Rhinosinusitis Italian Network: the Italian Registry for Severe, Uncontrolled Chronic Rhinosinusitis

This observatory aims to collect, as widely as possible, the Italian cases of patients with uncontrolled CRS. Patient will be enrolled by the centers of the Italian Network of Rhinosinusitis (Rhinosinusitis Italian Network: RINET), and they will be treated using a multidisciplinary team approach (allergists, otolaryngologists and pneumologists) in a real-world clinical set-up.

This real-life chronic rhinosinusitis registry aims at longitudinal data collection from patients attending specialist care centres across Italy.

The primary objectives of the study are:

* to characterize and to describe the evolution of uncontrolled Chronic Rhinosinusitis (CRS);
* to facilitate and to characterize the phenotyping and endotyping of CRS;
* studying the efficacy and safety of the principal therapeutic strategies and approaches to uncontrolled CRS in real-life;
* supporting the development of diagnostic methodologies and innovative therapeutic strategies for CRS;
* to evaluate the clinical and economic-health impact of the different therapeutic approaches (including systemic corticosteroids) used for uncontrolled CRS;
* to describe factors associated with therapeutic choices and how much this factors influence natural history of the CRS;
* Studying and identifying biomarkers and predictors of response to different therapies;
* to increase the "awareness" of CRS in patients, in public opinion, in the national and international scientific community, and in the Italian clinical community of the otolaryngologists, the allergists and the pneumologists.

Eligibility Criteria:
Inclusion Criteria:

* Participants with a confirmed diagnosis of bilateral Chronic Rhinosinusitis that have at least three (in case of patients previously treated with surgical approaches) or four (in case of patients never treated with nasal sinus surgery) of the following criteria:

  * Evidence of type 2 inflammation (at least 250 blood eosinophils per microliter and / or at least 10 eosinophils / HPF from a histological sample of sinus mucosa and / or at least one finding of moderate eosinophilia on nasal cytology and / or total serum IgE \>100 IU / ml);
  * at least two Short courses of systemic corticosteroids or lorg-term Systemic Corticosteroids therapy for Chronic Rhinosinusitis;
  * Significant deterioration in the quality of life (Sinonasal Outcome Test 22 - SNOT-22\>= 40 and / or Visual Analogue Scale - Global VAS of symptoms\>= 5);
  * Loss of Smell (VAS for hyposmia\> = 7)

Exclusion Criteria:

-
Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities

This study is investigating the potential effects of a high-intensity home-exercise program among children with cerebral palsy. The program includes rhythmic movements to music that are adapted for wheelchair uses and age-appropriate themes. This project has the potential to address a large knowledge gap in the extant literature, because there are no widely accessible, evidence-based, enjoyable, and age-appropriate modalities for improving cardiovascular fitness or cardiometabolic health among children with disabilities who have mobility disabilities.


Eligibility Criteria:
We are recruiting 50 parent-child dyads. Childs are the participant undergoing the exercise intervention. Parents are required to support the safety and schedule of the child participant. Parents are considered participants due to their responsibilities.

Inclusion Criteria:

* have a medical diagnosis of cerebral palsy, as determined by ICD-10 codes
* aged 6-17 years old
* a Gross Motor Function Classification System Level I-III (as determined via participant screening, explained in the protocol section below)
* medical clearance to participate in high-intensity exercise from a physician (using the attached medical screening form and explained in the intervention safety, monitoring, and response plan)
* access to a Wi-Fi Internet connection in the home via mobile phone or tablet computer
* a caregiver who will support and monitor the participant's safety during the intervention and manage the child's exercise schedule.

Exclusion Criteria:

* physically active (defined as \>150 minutes per week of self-reported moderate-to-vigorous intensity exercise in a typical week)
* cannot use their arms for exercise
* a Gross Motor Function Classification Level of IV-V
* complete blindness or deafness;
* Any past history of a contraindication to exercise testing according to American College of Sports Medicine (ACSM) guidelines (Liguori and American College of Sports Medicine, 2020): significant change in the resting electrocardiogram suggesting significant ischemia, myocardial infarction, or other cardiac event, unstable angina, uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise, symptomatic severe aortic stenosis, uncontrolled symptomatic heart failure, pulmonary embolus or pulmonary infarction, myocarditis or pericarditis, aneurysm.
* pregnant (due to radiation from a Dual Energy X-ray Absorptiometry \[DEXA\] scan)
* has not been seen by a physician within the last year
* uses a g-tube

Eligible caregivers will include parents or legal guardians of the child, who can commit sufficient time to support the child in their roles for the study and communicate in English. Caregivers who have complete blindness or deafness will be excluded from participation.
Study of End Tidal Carbon Dioxide (EtCO2) Variation After an End- Expiratory Occlusion Test as a Predictive Criteria of Fluid Responsiveness in Mechanically Ventilated Patients

Hypovolemia is one of major factor of haemodynamic instability. Fluid administration is not totally riskless. Indeed, it can create or inflate pulmonary oedema, alter gaz exchanges and increase post operative respiratory complications. Furthermore, fluid administration is not always followed by a cardiac output increase.

Predicting preload responsiveness before administering fluid by reliable and reproductible methods is necessary in critically ill patients.

Dynamic indicators are approved at the bedside such as passive raising leg test, pulse pressure variation, respiratory variation of the diameter of the superior vena cava. However, all these tests cannot be used for all patients. For example in the cases of spine or pelvis injury, or traumatic brain injury, patients with difficult condition for transthoracic echography.

The investigators hypothesize that EtCO2 (end tidal carbon dioxide) variation after an 15 seconds end-expiratory occlusion test could predict fluid responsiveness in mechanically ventilated patients in the intensive care units.

EtCO2 is a parameter which can be easy to collect, reproductible, and totally non invasive. This method could be especially appropriate for patients for whom the classical test of fluid responsiveness cannot be used

For each patient under mechanical ventilation, answering inclusions and non inclusions criteria, and eligible to a fluid perfusion, the physician in charge collect vital parameters such as cardiac frequency, blood pressure, cardiac output and end tidal carbon dioxide.

The cardiac output is measured by transthoracic echography, or invasive devices such as transpulmonary thermodilution or pulmonary arterial catheter.

The physician achieve a 15 seconds interruption of mechanical ventilation at end expiration, and collect the end tidal carbon dioxide variation.

Fluid perfusion of 500 ml of crystalloid is performed. Then the physician collect the same vital parameters, including a new cardiac output measure.

The patients for whom the cardiac output increased about more than 15 percent are considered as responders, the others are considered as non responders.

Furthermore, socio demographic parameter, reason for admission, parameters of mechanical ventilation, use of vasopressor drugs and water balance are collected.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years old
* critically ill patients
* under mechanical ventilation
* whose cardiac output is measurable by transthoracic echography, or monitored by a transpulmonary thermodilution catheter or pulmonary arterial catheter
* eligible to a fluid perfusion, by the physician in charge appreciation

Exclusion Criteria:

* younger than 18 years old
* pregnant patients
Finite Element and One Point Fixation

* A cone beam CT (CBCT) scan of the patient, will be used to create a 3D scanned image of ZMC
* 3D images will be introduced to finite element (FA)software to evaluate Stresses (MPa) and Life time (cycle) For each model and determine which point of fixation is the best
* After application this point of fixation on the patient
* Finite element analysis will be done again to verify the previous results


Eligibility Criteria:
Inclusion Criteria:

* Fit to general anesthesia (GA)
* Isolated minimally displaced zygomaticomaxillary complex (ZMC) fracture

Exclusion Criteria:

* absence of other facial trauma, mandibular condylar fracture
Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects

The primary objective of this study is to evaluate the safety and tolerability of ONO-2952 across ascending single doses in healthy adult male and female subjects. The secondary objective is to characterize the pharmacokinetic (PK) profile of ONO-2952. The tertiary objective of this study is to preliminarily evaluate the effect of a meal upon the PK profile of ONO-2952.


Eligibility Criteria:
Inclusion Criteria:

* Healthy non-smoking male or female subjects (18-55 inclusive)
* Body mass index (BMI) of 19-35 kg/m2 (inclusive)
* For females, surgically sterilized, postmenopausal, or who are non- lactating and agree to use a double barrier method of contraception

Exclusion Criteria:

* History or presence of clinically significant disease
Treatment of Iron Deficiency Anaemia in Pregnancy Study

The burden of anaemia remains unacceptably high during pregnancy. Over a third of women are anaemic by their third trimester of pregnancy. The most common cause is iron deficiency. One key factor is rising iron requirements throughout pregnancy. There are risks associated with anaemia for the mother and infant. Anaemia in the first and second trimester has been significantly correlated with low birth weight and pre-term birth, and is associated with impaired neurological development of the baby. It also increases the risk of intrauterine fetal death, and the likelihood of the mother requiring blood transfusions during or after delivery.This study is a prospective cohort study, which aims to better define the natural history and understand how to use oral iron therapy for iron deficiency anaemia in pregnant women. This includes documenting the impact of treatment on anaemia symptoms, side effects, and the level of success of iron therapy using several haematological tests. Pregnant women will be invited to participate in this study and treated using a treatment schedule as described in national guidelines. Additional blood samples will be taken for subsequent detailed analysis of pathways of iron metabolism to better predict the response to oral iron therapy during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women (any stage during pregnancy up to 36 weeks) and women in the puerperium (within 6 weeks postdelivery) with anaemia as defined by World Health Organization (WHO) criteria and described in British Society Haematology (BSH)/ British Committee for standards in Haematology (BCSH) guidelines.

  1. First trimester \< 110g/l
  2. Second and third trimester \< 105g/l
  3. Puerperium \< 100g/l
* Age: 18-45 years
* Agreement to participate in the study with consenting

Exclusion Criteria:

* Anaemic women presenting at or after 36 weeks as there may be insufficient time to delivery to assess responses to oral iron)
* Anaemic women affected by a (major) haemoglobinopathy e.g. B thalassaemia major sickle cell disease
* Women with overt clinical signs of sepsis
* Allergies to iron
* Hyperemesis Gravidarum / persistent vomiting
* Women with inflammatory conditions such as Crohns, ulcerative colitis, Systemic lupus erythematosus, Rheumatoid arthritis.
* Women with chronic renal failure
Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.

Total hip replacement is the most successful treatment modern healthcare can offer patients to regain quality of life. Periprosthetic joint infection (PJI) is the most common and devastating complication after total hip replacement (THR). Between 0.5 to 2% of primary THR (first time hip replacement), and 8-10% of revision THR (replacement of a hip prosthesis) will become infected.1 The introduction of local antibiotics blended into bone cement has led to a reduction in postoperative infection in primary THR by half.2 Unfortunately, cement can't always be used in relevant quantities.

The number of primary and revision surgeries of the hip is projected to increase dramatically. Therefore, the need for a feasible infection prophylaxis that is applicable for complex primary and revision THR in addition to antibiotics loaded cement is urgent.

Impacted morselized bone allograft is often used in (revision) THR to fill bone defects. Morselized allograft has been used as a carrier for local antibiotic treatment in multiple pilot studies and appears to be an attractive and effective treatment option, both for already infected joints and as a prophylactic measure in high-risk patients (e.g. THR revision surgeries). Nonetheless, a pivotal trial to support its use in THR is lacking. The aim of this pragmatic randomized controlled double blinded drug trial is to investigate whether antibiotic impregnated bone graft (AIBG) decreases the risk of infection after hip arthroplasty compared to controls treated with placebo impregnated bone graft. Patients scheduled for elective THR will be randomized to receive AIBG or a placebo impregnated bone graft. The primary outcome variable will be the number of re-operations due to infections and PJI diagnoses 2 years postoperative.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Hip arthroplasty requiring bone graft
3. Willing to provide informed consent.
4. For women of childbearing potential; a negative pregnancy test prior to reoperation.

Exclusion Criteria:

1. Ongoing prosthetic joint infection
2. Known allergies and contraindications for the use of vancomycin or tobramycin
3. Mental inability, reluctance, or language difficulties that according to investigator judgement, result in difficulty understanding the meaning of study participation
4. Expected difficulties to complete 2-year follow-up
5. Women of child bearing potential not using contraception
6. Pregnant women
7. Nursing women
Effect of 2-year Administration of CP-945,598 on Weight Loss Efficacy and Safety.

The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults

The CP-945,598 program was terminated on November 3, 2008 due to changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval. No safety issues were involved in the termination decision.

Eligibility Criteria:
Inclusion Criteria:

* Obese adults with a body mass index \> or = 30 kg/m ; \> or = 27 kg/m2 for those with obesity-related comorbidities including hypertension and dyslipidemia

Exclusion Criteria:

* Pregnancy
* Diabetes
* Adults with serious or unstable current or past medical conditions
Five-year Patency of No-touch Saphenous Vein Grafts in On-pump Versus Clamp-less Off-pump Coronary Artery Bypass Surgery

Randomised controlled trials (RCTs) have shown high long-term patency for no-touch saphenous vein grafts (NTSVGs), comparable to the internal thoracic artery in on-pump coronary artery bypass grafting (CABG). RCTs on patency in NTSVGs in off-pump CABG have not been published yet. Orebro University Hospital participated in the CABG Off- or On-pump Revascularization study (CORONARY, ClinicalTrials.gov number, NCT00463294) and included fifty-six patients. Accordingly, this is a sub-study and the aim was to assess the midterm patency in NTSVGs in clamp-less off-pump versus on-pump CABG at five-year follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patients were eligible if they:

  1. provided written informed consent;
  2. were \>21 years of age;
  3. required isolated CABG with median sternotomy;
  4. had at least one of the following risk factors:

     1. had peripheral vascular disease (previous peripheral bypass, amputation or anklebranchial index \<0.90),
     2. had cerebrovascular disease (history of stroke, transient ischemic attach or carotid stenosis ≥70%),
     3. had renal insufficiency (creatinine above upper limit of normal),
     4. were ≥70 years of age, or
     5. were between the ages of 60-69 with one of the following: i. had diabetes and taking an oral hypoglycemic agent and/or insulin, ii. required urgent revascularization (i.e., waiting in hospital for revascularization after an acute coronary syndrome), iii. were a recent smoker (within 1 year of randomization), or iv. had left ventricular ejection fraction ≤35%, OR
     6. were between the ages of 55-59 with two of the following: i. Diabetes and taking an oral hypoglycemic agent and/or insulin, ii. required urgent revascularization (i.e., waiting in hospital for revascularization after an acute coronary syndrome, iii. were a recent smoker (within 1 year of randomization), or iv. had a left ventricular ejection fraction ≤35%

Exclusion Criteria:

* Patients were excluded if they:

  1. required a concomitant cardiac procedure associated with CABG;
  2. had a contraindication to off-pump or on-pump CABG (e.g., calcified aorta, intramuscular left anterior descending artery, calcified coronaries, small target vessels);
  3. had a concomitant life-threatening disease likely to limit life expectancy to less than 2 years;
  4. were previously enrollment in the CORONARY Trial;
  5. required emergency CABG surgery (i.e., immediate revascularization for hemodynamic instability); OR
  6. required a redo CABG.
Evaluation of the Effect of Output on Skin Covered by a New Adhesive

The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive and a standard adhesive


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had an ileostomy for more than one year
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist) -

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Participating in other interventional clinical investigations or have previously participated in this evaluation
Vitamin K-absorption From Dairy

Lactic acid bacteria produce a mixture of higher menaquinones, including menaquinone-9 (MK-9) and menaquinone-10 (MK-10). Vitamin K1 (phylloquinone) is normally present in chloroplasts in green vegetables. A new dairy product is developed containing both vitamin K1 and K2-vitamins. However, the extent to which the various forms of vitamin K are absorbed from such a mixture is not known. In this study the absorption profile of phylloquinone and menaquinones from this new dairy product containing several K-vitamins is investigated. This study describes a dietary intervention experiment for one single cocktail containing several K-vitamins as part of a dairy product.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women between 20 and 45 years old
* Subjects of normal body weight and height according to BMI \< 30
* Subjects of Caucasian race
* Subject has given written consent to take part in the study

Exclusion Criteria:

* Subjects with (a history of) metabolic or gastrointestinal disease
* Subjects presenting chronic degenerative and/or inflammatory disease
* Abuse of drugs and/or alcohol
* Subjects receiving corticoid treatment
* Subjects using oral anticoagulants
Intercostal Nerve Cryotherapy in Patients Undergoing Minimally Invasive Pulmonary Resection

This is a research study designed to test whether a treatment called Intercostal Nerve Cryotherapy is an effective way to help control post-surgical pain for patients undergoing minimally invasive pulmonary resection.

There are two treatment groups in this study, a cryotherapy group and control group. Cryotherapy is a method of controlling pain by freezing nerves between the ribs that would transmit pain impulses to the brain.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 year and older.
2. Undergoing elective minimally invasive (VATS or robotic) lung resection for nodules (wedge resection, segmentectomy, lobectomy).
3. Performance status of 1 or 2.

Exclusion Criteria:

1. Patients with ejection fraction less than 40%
2. Patients with creatinine greater than 1.5.
3. Patients with Child's B or C cirrhosis
4. Patients on chronic narcotics for other reasons
5. Patients diagnosed with fibromyalgia
6. Patients who had previous thoracic surgery on the same side.
7. Patients who cannot communicate in English.
8. Patients unable to provide informed consent for the study.