cyrilzakka/clinical-trials huggingface dataset:
Specific Inspiratory Muscle Training (SIMT)in the Patients With Ventilatory Dependence

Prolong mechanical ventilation cause to respiratory muscle weakness and high risk to weaning failure,the investigators hypothesize that

1. Specific inspiratory muscle training (SIMT) using threshold loaded breathing device (BreatheMAX V.1)in patients with ventilator dependence will improve inspiratory muscle strength
2. SIMT will improve lung function in patients with ventilatory dependence.
3. SIMT will improve weaning success in patients with ventilatory dependence.

Prolonged mechanical ventilation cause detrimental effects on lung function and high risk of lung complications and standard weaning protocols are not successful in a number of patients. The strength of the inspiratory muscles is important factors in the success of weaning. Although, the inspiratory muscles are trained by manipulating the ventilator sensitivity and made of ventilation in the traditional protocol, the muscle function might not improved sufficiently to sustain independent and spontaneous breathing. Consequently, specific inspiratory muscle training is indicated and has been studied in patient with weaning failure. However, there is little evidence available and no firm conclusion can be drown. Therefore, the purpose of this study is to determine whether specific IMT training using the local made loaded threshold IMT device can improve lung function and accelerate the weaning process.

Eligibility Criteria:
Inclusion Criteria:

* Patient who have been mechanically ventilated \> 72 hours and start to weaning from medical order or ventilator dependent patients who have failed to wean prior to study.
* Normal arterial blood gas (PaCO2 \< 50mmHg, PaO2 \> 60 mmHg on FiO2 \<0.5 or SaO2 \> 90%, PH 7.35-7.45).
* Cardiovascular stability (HR ≤ 140 beats/min, systolic BP 90-140 mmHg and diastolic BP 60-90 mmHg, with no or minimal vasopressors)
* Good consciousness, cooperation and can sit in an upright position \> 30 minutes

Exclusion Criteria:

* Persistent homodynamic instability.
* Severe breathlessness at rest when spontaneous breathing.
* Coronary heart disease with angina.
* Life threatening arrhythmia (VF, VT).
* Sedation Ramsay scale \> 2
* Severity of disease APACHE II score \> 29
Trans Cranial Direct Current Stimulation Along With Craniosacral Therapy on Sleep Disturbances in Patients With Chronic Low Back Pain

Sleep problems in patients with CLBP are a very common complication and is the most neglected part of the management. Though previous literature suggested that sleep problems need to be managed in patients with CLBP, no physical therapy or manual therapy techniques has been checked for their efficacy to manage the same. Therefore, there is a need to check the efficacy of various physical therapy and manual therapy techniques so that sleep problems associated with CLBP can be managed effectively by physical means. The main purpose of the study is to check the efficacy of tDCS and CST to improve sleep, pain and quality of life in patients with CLBP.


Eligibility Criteria:
Inclusion Criteria:

1. People with chronic low back pain (more than 3 months)
2. Both males and females.
3. 18-50 years
4. Able to follow verbal commands.

Exclusion Criteria:

1. Diagnosed with primary sleep disorders
2. Pregnancy
3. Taking any medication for a psychological disorder
4. Acute or subacute LBP
5. Diagnosed with any other systemic disorder.
6. Spinal tumour.
7. Radicular pain and nerve root compression.
8. Severe spinal stenosis, spondylolisthesis, fibromyalgia.
9. Unstable angina and other cardiovascular disorders.
10. Malignancy.
11. History of other systemic and inflammatory disease.
Effectiveness & Safety of Neofitoroid® in Hemorrhoidal Disease

Evaluation of the effect and safety of NeoFitoroid® in reducing symptoms in patients with hemorrhoidal disease.

Evaluation of the effect and safety of NeoFitoroid® in relieving discomfort symptom after 10 days of treatment compared to baseline (pretreatment).

The study duration per patient is 31 days (visit 1 + 10 days treatment + 20 days follow-up).

Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sexes ≥ 18 years .
2. Diagnosis of hemorrhoidal disease of grade I or II, non thrombosed, according to Goligher's classification performed by anoscopy/rectoscopy at screening.
3. Patient is not expected to require non-pharmacological (as Sclerotherapy, Rubber band ligation, Infrared Coagulation, Radiofrequency Ablation, Cryotherapy) or surgical treatment in the 31 days post enrollment .
4. Discomfort score related to the hemorrhoidal disease ≥ 30 measured through a 0-100 Visual Analog Scale VAS (from "no symptoms" to "overwhelming symptoms") at screening.
5. Women of childbearing potential undergone a negative pregnancy test.
6. Informed consent documentation signed and dated confirming that the patient has been adequately informed of all aspects related to his/her participation in the clinical study and is willing to participate.

Exclusion Criteria:

1. Patients with gastrointestinal disease like inflammatory bowel disease, celiac disease, colo-rectal cancer, perianal/fistulizing disease).
2. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and/or that, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
3. Patients with active cancer.
4. Tubercolosis , mycosis, Herpes Symplex, virologic disease with anal or perianal skin localization.
5. Presence of physical and/or mental disability that reduces the ability to take medicines as expected.
6. Concomitant abuse of drugs or alcohol.
7. No adequate reliability or presence of conditions that may result in non-compliance / adherence of the patient to the Protocol.
8. Subjects with known or suspected allergy to plants of Helichrysum family, aloe vera, Ruscus, Hypericum, Jojoba Oil, Shea Butter, Essential oils of: Melaleuca, Cypress and Peppermint.
9. Subjects with known or suspected allergy to ingredients such as: glicerilstearato, Caprylic / capric, sucrose distearate, sucrose stearate, cetearyl alcohol, vegetable glycerin, triidrossistearina, vegetable oils, hydrogenated vegetable oils, Candelilla wax, xanthan gum, citric acid, tocopherols, sodium silicate, benzyl alcohol, potassium sorbate, sodium dehydroacetate, Sunflower oil.
10. Subjects with the presence of alarm symptoms (weight loss, lack of appetite).
11. Prior use of other topical ointment for the treatment of haemorrhoid within 14 days before enrollment.
12. Pregnant and/or breastfeeding patients.
13. Participation in interventional research studies of investigational medicinal or device products (ongoing or terminated less than 30 days before screening).
Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia

The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to chlorambucil in patients with untreated Chronic Lymphocytic Leukemia.

Chlorambucil, is currently approved for treatment of frontline chronic lymphocytic leukemia, especially, but not limited to the ailing and elderly patient population. Several other more aggressive treatment options are available (e.g. fludarabine), however they are not suitable for all CLL patients, especially the ailing and elderly, due to greater toxicity. Ofatumumab is effective with low toxicity. The addition of ofatumumab to chlorambucil offers potentially a more effective therapy, with limited toxicity. The objective of this study was to evaluate progression-free survival (PFS), overall response and overall survival in subjects with previously untreated CLL with ofatumumab added to chlorambucil versus chlorambucil.

Eligibility Criteria:
Inclusion Criteria:

* confirmed CLL diagnosis and active CLL requiring treatment
* considered inappropriate for fludarabine-based therapy
* not been treated for CLL before
* fully active at a minimum or fully capable of selfcare and up and about more than 50% of waking hours
* age 18yrs or older
* signed written informed consent

Exclusion Criteria:

* prior CLL therapy
* abnormal/inadequate blood values, liver, and kidney function
* certain heart problems, active or chronic infections, serious significant diseases, active autoimmune hemolytic anemia (AIHA) requiring treatment, other current cancer or within last 5 years
* CLL transformation
* CLL central nervous system involvement
* current participation in other clinical study
* inability to comply with the protocol activities
* lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception
Pharmacogenetics Analysis of Fentanyl Administered in Newborns

Fentanyl is an opioid drug used as analgesic and anaesthetic also in Neonatal Intensive Care Units (NICU), according to the last national and international recommendations, during invasive life support strategies such as mechanical ventilation. Opioids manifest their sedative effect through activation of μ-opioid receptors, which are abundant both in the central and peripheral nervous system. Comparing fentanyl to morphine we can appreciate a much more powerful effect (75-220 major) with lower doses to obtain similar analgesic effect; these characteristics are due to the high lipophilicity of the molecule which easily crosses the blood-brain barrier (BBB). At the same time, fentanyl shows less adverse effects than morphine such as vomiting, nausea, gastrointestinal constipation, respiratory depression, dependence and tolerance. The drug is extensively metabolized by liver enzymes.

In routinary clinical practice it has been observed that large interindividual differences are found in the daily dosages needed to achieve pain control. Literature evidences that pharmacodynamic variation related to genotypes in receptor signalling or pain modulators may play an important role in this variability. Many genes are related to fentanyl pharmacodynamics and pharmacokinetics. Some polymorphism in these genes are already known to correlate with toxicity or efficacy of the drug, also in the paediatric population. More polymorphisms could be involved in abnormal pharmacodynamic or pharmacokinetics of fentanyl, therefore studies are necessary to better explain the possible role of pharmacogenetics in precision medicine especially in a very specific population as newborn.


Eligibility Criteria:
Inclusion Criteria:

1. all newborns on mechanical ventilation receiving fentanyl
2. parental written informed consent for participation in the study must be obtained

Exclusion Criteria:

1. Concurrent or previous opioid and/or midazolam administration (72 h interval required)
2. Known genetic or chromosomal anomaly
3. Probable rapid extubation
Electronic Medical Records and Genomics

The purpose of this study is to develop a biobank containing samples of 2,000 patients treated in a tertiary cardiology hospital containing electronic medical records and genetic data in genome-wide scale for performing genetic association studies for validation and development of medical decision routines that help the clinical management of heart failure patients.

Patients between 18 and 80 years old with heart failure diagnosis of different etiologies and left ventricular ejection fraction \< 50% in the past 2 years will be eligible for enrollment on the cohort. After consent, patients will be submitted to clinical baseline, echocardiographic, cardiography impedance and biochemical evaluation. Study data will be collected and managed using Research Electronic Data Capture (REDCap) tools. The follow up will take place every 6 months to assess cardiovascular outcomes (all-cause mortality, cardiovascular mortality, hospitalization for worsening heart failure and current medication use). Initial analytical strategy will focus on the establishment of the accuracy of electronic medical records extraction protocols for main predictor factors of morbidity and mortality in heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years old
* Heart failure diagnosis of different etiologies
* Left ventricular ejection fraction \< 50% in the past 2 years

Exclusion Criteria:

* Patients with impaired cognition due to advanced dementia syndrome or severe psychiatric disorder
* Patients without telephone access
* Patients that refused to participate
Non-hormonal Medical Device for Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women

Randomized (1:1), double-blind, sham-controlled, 2-arm parallel study comparing effectiveness and safety of non-hormonal medical device versus sham device to treat VVA in post-menopausal women.

After screening and baseline assessment, participants, ages 21 to 65 years of age, will be randomized and followed for a 12-week intervention period. After the primary endpoint evaluation at week 12, each participant in both arms will immediately commence an open label period using an Active device for week 13 to 1 year to collect further effectiveness and safety data.

Eligibility Criteria:
Inclusion Criteria:

* Women with menopause defined by last menstrual period at least 12 months prior to screening, or 6 months of amenorrhea with serum FSH levels \> 40 mIU/ml, or 8 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
* Sexually active women.
* Participant experiencing subjective moderate-to-severe vaginal pain with sexual intercourse.
* Participant experiencing subjective moderate-to-severe vaginal dryness.
* Gynecological exam confirming vaginal atrophy.
* Willingness to give voluntary written informed consent to participate in the study and comply with protocol requirements.

Exclusion Criteria:

* Use of systemic or local estrogen therapy, currently or in the last 6 months or planned use during the study.
* Use of any other treatment for vaginal atrophy, 6 weeks prior to enrollment or planned during the study period.
* Investigational drugs and also prescription and nonprescription medications/remedies known to treat VVA within 60 days of enrollment or during the study.
* Vaginal stenosis.
* Pelvic floor disorders.
* Prior pelvic radiation therapy including radiation or surgery to the vulva/vagina.
* Active urinary tract, yeast, or other active gynecologic infections.
* Active connective tissue disorders such as lupus or Sjogren's syndrome.
* Active malignancies.
* Diagnosis of vulvodynia or other pelvic pain in the vagina or vulvar area.
* Vulvar dermatoses.
* Laser or radio frequency vaginal rejuvenation treatment or planned treatment during the study.
* Any medical condition that, in the investigator's opinion, would interfere with their participation and/or completion in the study.
Early Warning of Intradialytic Hypotension in Hemodialysis Patients

In this study, the investigators will monitor patients undergoing hemodialysis treatment with a non-invasive wearable PPG-based device. Measurements will include blood pressure, heart rate, oxygen saturation, stroke volume, cardiac output, cardiac index and systemic vascular resistance, among others. The aim is to diagnose intradialytic hypotension more rapidly than with current noninvasive methods and prevent related poor outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with EKSD undergoing chronic hemodialysis treatments for \> 3 months.
2. Patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
3. Patients must satisfy a medical examiner about their fitness to participate in the study.
4. Patients must provide written informed consent to participate in the study.

Exclusion Criteria:

1. Patients with an inability to communicate well with the Principal investigator (PI) and staff (i.e., language problem, poor mental development, or impaired cerebral function).
2. Withholding the dialysis session for any reason prior to initiation.
3. Minors under the age of 18.
IntuBrite Versus Macintosh for Endotracheal Intubation in Out of Hospital Cardiac Arrest

a randomized, parallel, non-blinded trial in a single Emergency Mdeical Service in Poland within a group of 34 ground ambulances crews, comparing time and first pass success (FPS) for endotracheal intubation (ETI) in DL using the IntuBrite® (INT) and Macintosh laryngoscope (MCL) during cardiopulmonary resuscitation (CPR). intubations will be performed using INT and MCL based on an intention-to-treat analysis. The FPS time of the ETI attempt will be analysed. First attempt success will be counted.

Investigators designed a prospective observational study to compare INT (IntuBrite®, LLC; Vista, CA, USA) and MCL for ETI performed by paramedics in OHCA without an emergency physician on the scene. The main goal was to determine whether INT is superior to using an MCL laryngoscope during a tracheal intubation attempt in nontraumatic OHCA, in terms of time and effectiveness.

The time of intubation was measured using an electronic stopwatch. Time measurement began when the paramedic held the selected laryngoscope and declared their readiness to perform the procedure.

The effectiveness of the first ETI attempt for instrumental airway management for nontraumatic adult OHCA and end-tidal carbon dioxide monitoring was used to confirm correct device placement in all patients.

The degree difficulty of intubation attempts for all of the patients included in the study. A long-term survival and a cost-effectiveness analysis were not included within this trial.

The investigators will collect case report forms (CRFs) from patients after OHCA within a 40-month period.

The average professional experience of the paramedics in instrumental airway management will be noted (DL and LMA). The primary outcome is the FPS time of the ETI attempt performed by the paramedics.

The success rate on the first intubation attempt will be counted.

Eligibility Criteria:
Inclusion Criteria:

* patients in cardiac arrest , requiring cardiopulmonary resuscitation

Exclusion Criteria:

* suspected difficult intubation
Validity of Korebalance Balance System

In postmenopausal osteoporosis patients, the balance is impaired. Equilibrium is evaluated with various test and balance systems. This study aims evaluation of the patients with the Korebalance Balance System and balance tests and investigation the validity of the Korebalance Balance System.

53 postmenopausal osteoporosis patients were evaluated with balance tests (Berg Balance Scale (BBS) and Timed Up and Go Test (TUG)) and Korebalance Balance System. The Korebalance Balance System is a balance assessment and exercise system. The higher the score, the greater the deterioration in the balance. The results of static and dynamic balance evaluation are recorded as score values. In this study, investigators compared Korebalance Balance System, Berg Balance Scale (BBS) and Timed Up and Go (TUG) tests and other demographic and clinical parameters (age, body mass index (BMI), 25OHvitD level, menopause age, fall within the last 1 year, fracture history, history of fracture in mother).

Eligibility Criteria:
Inclusion Criteria:

* Having postmenopausal osteoporosis
* No other disease that can cause balance disorder
* Volunteer participation in the study

Exclusion Criteria:

* To have a disease that will cause balance disorder,
* Having understanding problem to prevent communication with the patient,
* The lack of motor function to the balance device.
Sexual Dimorphism Analysis in Egyptian Population by Locating the Mandibular Canal Using CBCT

Sexual dimorphism analysis in Egyptian population by locating the mandibular canal using cone-beam computed tomography: an observational cross sectional study

Many studies from different countries such as United States, China, Japan, and Europe were done to observe the distinct morphologic and morphometric manifestations of sexual dimorphism. Accordingly, it is mandatory to target a specific population with their unique skeletal features.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and above.
* Absence of large pathological lesions in mandible.
* Dentulous patients

Exclusion Criteria:

* Patients younger than 18 years old
* Presence of large pathological lesions in mandible
* Completely edentulous patients.
Telerehabilitation for Dysautonomia in Parkinson's Disease

People diagnosed with Parkinson's Disease (PD) exhibit a combination of motor and non-motor symptoms, with the latter posing challenges in terms of identification and management. These non-motor symptoms tend to manifest before the motor symptoms and progressively worsen over time, significantly impacting the symptoms and everyday life activities of those affected. However, there remains a noticeable lack of scientific literature addressing the assessment and rehabilitation of cardiovascular dysautonomia in PD patients. Thus, our research aims to address this gap by pursuing the following objectives: 1) assess the feasibility, acceptability, and potential effectiveness of a hybrid telerehabilitation program designed to target cardiovascular health in individuals with Parkinson's disease; and 2) characterize cardiovascular dysautonomia using non-invasive measurements of cardiovascular and autonomic nervous system (ANS) function and self-reported symptom assessments.

This pilot clinical trial employs mixed methods and aims to recruit 16 participants meeting the criteria of stage 1 to 3 Parkinson's disease according to the Hoehn and Yahr scale, aged 50 or above, under optimized drug therapy, having home internet access, and without exercise contraindications, but exhibiting cardiovascular dysautonomia based on positive clinical results from active orthostatic hypotension maneuver, with or without reported symptoms and/or SCOPA-AUT questionnaire score ≥ 2/3 items. The 12-week telerehabilitation program comprises three weekly sessions, encompassing different exercise modalities to improve walk capacity (aerobic, strength, balance, coordination, flexibility) and education on symptom management. A progressive increase in autonomy is implemented, starting with synchronous/asynchronous sessions of 3/0 in week 1 to 0/3 in week 12. Feasibility (recruitment, adherence, retention), acceptability (questionnaire, semi-structured interviews), and potential effectiveness on motor (walking, mobility, balance) and non-motor aspects (pain and cardiovascular dysautonomia) will be measured before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients with PD (1 to 3 on Hoeh\&Yahr)
* Patients under treatment with optimized drug therapy. Medication is stable for at least 1 month
* Patients with access to the internet
* Speaking French or English
* 50 years or older
* Patients having cardiovascular dysautonomia according to the clinical criteria: supine hypertension (SH) (≥140/90 mmHg) and/or orthostatic hypotension (OH) (a drop of systolic blood pressure ≥ 20 mmHg and/or diastolic blood pressure ≥ 10 mmHg during the active orthostatic hypotension test).

Exclusion Criteria:

* Major cognitive impairment (Montreal Cognitive Assessment, score ≤ 24)
* Neurological disorders other than PD
* Musculoskeletal or cardiopulmonary disorders preventing physical activity, contraindication to physical activity, or presence of a cardiac pacemaker.