cyrilzakka/clinical-trials huggingface dataset:
A Study of HYML-122 in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

this is a single-arm, open, multicenter, phase 2 study to evaluate the efficacy, safety and pharmacokinetics of HYLM-122 monotherapy in Chinese subjects with FLT3 positive relapsed or refractory acute myeloid leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Fully understand the procedures of the clinical study and participate voluntarily with signed and dated written informed consent form, comply with the requirements of the study protocol.
* Males and/or females at least 18 years old when signing the informed consent form.
* Histologically confirmed AML (defined using WHO criteria 2016) with one of the following:

Refractory to at least 1 cycle of induction chemotherapy. Relapsed after achieving remission with a prior therapy.

* Subject is positive for FLT3 mutation in bone marrow or blood after completion of the subject's last interventional treatment.
* Eastern cooperative oncology group performance status (ECOG) ≤2 at screening.
* Life expectancy of at least 3 months.
* Women of childbearing potential have a negative pregnancy test at baseline and are willing to employ an effective method of contraception for the entire duration of study treatment and 6 months after the last dose.

Exclusion Criteria:

* Known or suspected allergies to any of the investigational drug composition (HYML-122, lactose, hydroxypropyl cellulose, hyposubstituted hydroxypropyl cellulose, silicon dioxide, magnesium stearate, titanium dioxide and polyethylene glycol).
* Medical history and surgical history excluded according to the protocol.
* Any previous medical treatment history exclude from the protocol.
* Abnormal laboratory results exclude from the protocol.
* Combination of treatments and/or drugs required during the study period and cannot be discontinued that excluded from the protocol.
* Alcohol abuse within 6 months prior to screening, defined as long-term drinking history, generally more than 5 years, equivalent to alcohol quantity ≥40g/d for men, ≥20g/d for women, or heavy drinking history within 2 weeks, equivalent to alcohol quantity ≥80g/d. alcohol volume (g) conversion formula=alcohol consumption (mL)\*alcohol content (%)\*0.8.
* Abortion less than 30 days prior to screening, pregnant and lactating women (currently breast-feeding or less than one year after delivery although not breast-feeding), women of childbearing potential who are not guaranteed effective contraception during the study, planning pregnancy or donating eggs or sperm within 6 months after the last dose.
* History of drug abuse or drug addicts.
* Subjects may not be able to complete the study duo to poor compliance or other reasons, or unsuitable for the study by the investigator's judgment.
Silodosin in Management of Lower Ureteral Stones

This research aims to study the effectiveness of silodosin in the management of lower ureter stones larger than 6 mm in diameter in terms of affected ureter (right or left), the size of the stone, the degree of hydronephrosis, the rate of stone expulsion(day), whether the stone was completely expelled or not, and the side effects of silodosin.


Eligibility Criteria:
Inclusion Criteria:

* Patients attending the urology Clinic with a distal unilateral ureteral stone larger than 6 mm in diameter.

Exclusion Criteria:

* Patients under 18 years of age
* Pregnant women
* Patients with whom we were unable to contact
* Patients treated with silodosin for another reason
* Single kidney patients
* Patients with bilateral ureter stones
* Patients with deteriorating kidney function
* Patients with grades 3rd and 4th of hydronephrosis
Comparison in Need for Bank Blood Between Patients Undergoing Total Hip Surgery That Either Receive Their Own Blood Back or Not

The study is a prospective, controlled, randomised and assessor blind study that investigate if the need for bank blood transfusion could be reduced in patients, undergoing primary or revision total hip replacement surgery, who receive their own blood back with the medical device Sangvia.

A comparison in need for bank blood will be made between patients that either receive their own blood back or not.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Scheduled for primary or secondary, cemented or non-cemented, total hip arthroplasty
* Classified as ASA Physical Status Classification System class P1, P2 or P3 according to the American Society of Anaesthesiology.

Exclusion Criteria:

* Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
* Previous enrollment or randomisation of treatment in the present study
* Expected or confirmed participation in another clinical study, that may interfere with the present study, during the study period
* Suspected severe non-compliance to protocol as judged by the investigator
* Current symptoms of haemophilia
* Current symptoms of hyperkalaemia
* Current symptoms of systemic infection or local infection in the operation field
* Current symptoms of impaired renal function including creatinine/clearance levels above the normal reference values
* History of or presence of malignant disease with propensity for systemic spread during the last 5 years
* Current or expected use of cytotoxic drugs
* Current untreated anaemia (e.g. sickle cell anaemia), i.e. Hb concentration \< 11 g/dl (7 mmol/l)
* Use of recombinant erythopoetin
* Use of aprotinin and/or fibrin sealant
* Use of other autologous blood transfusion than that with the Sangvia® system (e.g. CellSaver, pre-donation, acute normovolemic haemodilution etc.)
* Women of childbearing age
* Fractures
* Revision/secondary total hip surgery with expected serious bone grafting
Ultrasound Parameters for Difficult Videolaryngoscopy

Ultrasound has become an essential tool for the daily work of any doctor, but in certain specialties such as Anaesthesiology, its use has greatly increased the safety offered to patients throughout the perioperative period, either to perform nerve blocks, for vascular access, intraoperative hemodynamic management or any other use that allows increasing quality of care.

The management of the upper airway and the diagnosis of pathological conditions are essential skills for any doctor especially for Anaesthesiologist, ER physician, or Intensive Care physician. Because an inadequate airway management continues to be an important contributor to patient mortality and morbidity, any tool that can improve it should be considered as an addition to conventional clinical evaluation.

Unfortunately, most of the clinical parameters that should allow us to assess a potential difficult airway, do not always lead us to an adequate prediction, that is why US(Ultrasound) is use as an emerging tool in many fields, is also gathering strength in this search for a definitive predictor parameter.

Ultrasound has many obvious advantages (safe,fast, repeatable, portable, widely available and gives dynamic images in real time).

Sonographic studies are operator-dependent and although the identification of basic structures could be acquired with only a few hours of training, but more complex studies require a learning curve of months or even years. The high frequency linear probe (5-14 MHz) is probably the most suitable for the airway because images are of superficial structures (within 0-5 cm below the skin surface).

The growing academic interest in the use of US to look for predictors of difficult airway is centred mainly on measurements at the level of pretracheal tissues. But the greatest limitation of these studies is the disparity of the fat distribution that exists between different ethnic groups and and sexes, and the lack of standardization method in patient´s intubation conditions.

So, this study propose to assess different ultrasound windows at the level of pretracheal tissues such as independent predictors of Difficult Vydeolaryngoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patients (male or female) ASA I-III, aged between 18 and 90 years, undergoing scheduled surgery requiring orotracheal intubation. The signature of the informed consent is required authorizing its inclusion in the study.

Exclusion Criteria:

* Obesity class II defined as a BMI greater than 35.
* Pregnant.
* Cervical tumors, goiter or patients who have required radiotherapy at the cervical level
* Abnormalities that condition anatomy alterations such as facial / cervical fractures.
* Maxillofacial abnormalities
* People who cannot give their consent
High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy

We want investigate if high intensity training can increase daily functionality without causing muscle damage in patients Spinal and Bulbar Muscular Atrophy . We want to study if there is a difference in effect with supervised and unsupervised training. Furthermore we want to study if a supervised training program will motivate participants to continue training by the end of the program.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Spinal and bulbar muscular atrophy or
* Healthy control subjects matched individually with participating patients on age, sex, BMI and activity level.

Exclusion Criteria:

* More than 1 hour of fitness weekly before inclusion
* Other disease possibly confounding the results
* Pregnancy or breastfeeding
* Participations in other scientific studies wich could influence on the results during the last 30 days before inclusion.
* Physical and/or mental conditions preventing participating in the study protocol.
Improvement of Physical and Physiological Parameters Through the Use of a Mobile App

To investigate the health effects of a new mobile application (app) for prevention and personalized treatment in people with chronic cardiovascular pathologies associated with body composition.

Scientific evidence has shown that the adoption of the Mediterranean diet is a protective factor against the appearance of several types of cancer, cardiovascular diseases, aging and obesity due to the amount of nutrients with anti-cancer, anti-inflammatory and anti-obesity properties that jointly contribute to the maintenance of health status. The antitumor effects of the Mediterranean diet are mainly due to the combination of antioxidant elements, fiber and polyunsaturated fats. Therefore, this dietary pattern is essential as a preventive measure against the onset of cancer and other chronic diseases, but also to reduce health care costs.

Monitoring physical activity should be considered as a central factor when addressing precision nutrition. Perform physical activity and exercise, as they are key components of energy expenditure and balance, in addition, structural changes occur in muscles, increase in the number of mitochondria in fiber, secretion of metabolically beneficial hormones with reversal of muscle insulin resistance and reduction of hepatic lipogenesis. Regardless of intensity, short-term exercise has been shown to improve adiposity and insulin sensitivity, which may help reduce metabolic risk. Boutcher et al. also demonstrated that intermittent aerobic and anaerobic exercise performed at an intensity \>70% of maximal oxygen uptake significantly reduces ambulatory and office blood pressure in hypertensive individuals.

The development of this app aims, through self-management and visualizing the altered parameters and how they will evolve in your body in the short, medium and long term, to increase the population's commitment to these pathologies, in order to improve their health.

Eligibility Criteria:
Inclusion Criteria:

* Men and women over 21 years of age

Exclusion Criteria:

* Volunteers who do not have access to a smartphone.
Real-world Ruxolitinib Experience in PV

This is a multicentric, observational, retro-prospective study in adult PV patients - resistant or intolerant to hydroxyurea - who are going to receive or have already initiated treatment with ruxolitinib according to the approved local label. Enrolment will last 9 months after the first enrolled patient. Patients will be observed for a minimum of 3 months, in order to evaluate the primary endpoint for all patients.

This is a multicentric, observational, retro-prospective study in adult population who have been diagnosed with polycythemia vera according to the 2022 (WHO or ICC) criteria, who are resistant or intolerant to hydroxyurea and who are going to be prescribed or have already initiated treatment with ruxolitinib according to the approved local label. Patients who started treatment with ruxolitinib - according to clinical practice - will be enrolled. Enrolment will last 9 months after the first enrolled patient. Patients will be observed for a minimum of 3 months, in order to evaluate the primary endpoint for all patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥ 18 years of age
2. Subjects must be diagnosed with PV according to the 2022 World Health Organization (WHO) or International Consensus Classification (ICC) criteria
3. Subjects must have a treatment history for PV that meets the definition of resistance or intolerance to hydroxyurea (HU) in accordance with the indications of the Italian Medicines Agency
4. Patients already on ruxolitinib treatment (retrospective cohort) at the start date of the study or patients who will start ruxolitinib (prospective cohort) during the study enrollment
5. Signed informed consent

Exclusion Criteria:

1. Different diagnosis from PV \[eg. other chronic myeloproliferative neoplasia such as essential thrombocythemia, myelofibrosis; or of congenital erythrocytosis or secondary erythrocytosis\]
Clinical Evaluation of Bedside Pulse Lavage Irrigation Device

This study evaluates how subjects with intact skin tolerate a water jet (psi 10-12) and how well the water stream is contained by a new containment device.

Pulse lavage irrigation is an effective method of cleaning both acute and chronic wounds. The major drawback to pulse irrigation is that it is extremely messy and can easily contaminate the patient's surroundings, putting other patients and the person operating the device at risk. In order to obtain the benefits of pulse lavage, we have created a device that will contain the water spray from the lavage and protect both the patient and their surroundings. This study evaluates how well the device contains the spray from pulse lavage and how well subjects with intact skin tolerate pulse lavage when awake.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be healthy and willing to complete the study procedures.

Exclusion Criteria:

* Subjects must not have any chronic pain conditions or take any pain medications on a regular basis. Must not have any chronic wounds. Must not have any medical conditions that interfere with pain sensation. Must not have an allergy to skin adhesives. Patients must not be taking any immunosuppressive medications. Patients must not have any chronic infections.
Naturalistic Teaching Strategies in Children With Autism

The study will show the effect of naturalistic teaching strategies and picture exchange communication systems in children with an autism spectrum disorder. There will be two groups in this study. One control group and the other experimental group.

One group will be provided with the naturalistic teaching strategies and pecs therapy both and the other group will be provided with the PECS therapy. The research will be conducted within the duration of six months after the approval from BASR.

The two groups will be first assessed using the portage early education program and pecs manual. After 20 sessions of respective therapeutic techniques, both of the groups will be reassessed. The results of both of the groups will be then compared and conclusions will be drawn.

The Naturalistic Teaching approach is both adaptive and reactive to the needs of the kids with autism. Its methods are designed to be incorporated into the routines of children with an autism spectrum disorder. The naturalistic methods are intended to mimic the natural instructions a child receives in a variety of contexts.

PictureExchange Communication System (PECS) is a unique communication training program that was developed as a means of evading some shortcomings associated with these strategies. Many individuals with autism are candidates for augmentative and alternative communication (AAC) systems, either to supplement (i.e., augment) their existing speech or to act as their primary (i.e., alternative) method of expressive communication. Presently, aided, picture-based AAC systems are used more frequently and successfully with individuals with ASD. PECS consists of six phases and begins by teaching an individual to give a single picture of a desired item or action to a "communicative partner" who immediately honors the exchange as a request.

Eligibility Criteria:
Inclusion Criteria:

* Children who will be diagnosed with autism spectrum disorder and with speech and language impairments and will fall in the chronological age of language development (3-8) years
* Both genders
* Children who will have a vocabulary of 0-10 meaningful words
* Children with mild and moderate autism

Exclusion Criteria:

Children already taking speech therapy sessions

* Children with severe to a profound level.
* Children with any other disorder along with autism
Assessment of Metabolic Complications in Patients With Adrenal Tumors Through Radiological Images

Retrospective study based on data already available at each Center. Pseudonymized CT images of each patient in DICOM format will be sent from each center to the Coordinating Center to perform radiomics analysis.

Retrospective study based on data already available at each Center. Participating Centers will identify patients based on shared inclusion/exclusion criteria. Pseudonymized CT images of each patient in DICOM format will be sent from each center to the Coordinating Center to perform radiomics analysis. Images will be transferred via File Transfer Protocol while respecting the anonymity of enrolled patients. Images will be deposited in a dedicated study folder created by the AOUBO ICT Service. Images will be accessible only to the Investigator and Principal Investigator and/or their delegates via personalized credentials, which can be accessed only from IRCCS AOUBO computers and facilities. The folder to which the images will be transferred will be accessible only to the Principal Investigator and his/her Collaborators through customized private credentials usable only through IRCCS AOUBO networks, computers and facilities. Radiomics, which will be applied to existing CT images, will in no way affect the care pathway of patients

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Patients with adrenal tumor who underwent adrenectomy surgery from 1-1-2000 to 30-5-2023, performed according to clinical necessity and indications of international guidelines,with availability of histologic diagnosis or adrenal tumor that did not undergo adrenectomy surgery with diagnosis of benignity confirmed by radiologic stability at 6-12 months after first finding(as indicated in guidelines)
* Availability of radiological images in DICOM format of abdominal CT scan in which the adrenal tumor is first described, obtained on the date of first evaluation at the participating center (necessarily before surgery for patients undergoing adrenectomy)
* Signature of informed consent

Exclusion Criteria:

* none
High Interval Versus Moderate Intensity Continuous Training on Soluble st2 Biomarkers in Chronic Heart Failure

This study was designed to compare between the effect of high intensity interval training (HIIT) and moderate intensity continuous training (MICT) on soluble ST2 biomarkers among chronic heart failure patients, also measure the improvement in the quality of life with different modes of exercise and with of it is more benifitial for the heart failure patient

The data concerned with the study including soluble ST2 biomarker levels, ejection fraction and MLHFQ was measured before and after twelve weeks of treatment.In this study a total sixty male patients with chronic heart failure NYHA class (I \&II) were selected from the outpatient clinic, El-Demerdash hospital, Ain-shams University. Their age ranged from 50-60 years. Patients were randomly assigned into two groups, group A receiving HIIT along with prescribed medical treatment and group B receiving MCT along with prescribed medical treatment.

Eligibility Criteria:
Inclusion Criteria:

* The patients selection was according to the following criteria:

  * Patients diagnosed with chronic heart failure (New York heart association class I\& II) with systolic left ventricular dysfunction.
  * Their left ventricular ejection fraction (LVEF) \<40%.
  * Medical treatment was optimized at least three months prior to study entry.
  * All patients didn't participate in any rehabilitation programs prior to the study.

Exclusion Criteria:

* Patients who had met one of the following criteria were excluded from the study:

  1. Signs of acute heart failure, unstable angina or severe arrhythmia three months prior to enrolment in the study.
  2. Pacemakers.
  3. Chronic obstructive pulmonary disease.
  4. Other disorders counteracting exercise testing conditions that limit lower limb mobility (for example, burns, fractures)
  5. Pre-existing neuromuscular diseases (for example Myasthenia Gravis).
Study to Assess Safety, Tolerability and Pharmacokinetics After Single and Multiple Doses of AZD1446 to Japanese Subject

The primary aim of this study is to assess the safety and tolerability of AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese subjects, aged ≥20 to ≤50 years for male young subjects, ≥65 to ≤80 years for male or post-menopausal female elderly subjects.
* BMI between 18 and 27 kg/m2 and weigh at least 50 kg and no more than 90 kg (for the elderly female, weigh at least 45 kg and no more than 90 kg).

Exclusion Criteria:

* History of Quincke oedema or angiooedema, or history of repeated episodes of urticaria.
* History or present symptoms or signs of asthma, airway hyperreactivity or obstructive lung disease.