cyrilzakka/clinical-trials huggingface dataset:
Efficacy Study of Azithromycin-based Therapy for Bronchiolitis Obliterans

\[Study Objectives\]

* To evaluate the efficacy of azithromycin, N-acetylcystein, and inhaled corticosteroid combination therapy in patients with bronchiolitis obliterans as a complication of allogeneic hematopoietic cell transplantation in terms of response rate at 6 months after treatment initiation based on the improvement of FEV1.

* Bronchiolitis obliterans (BO) is a graft-versus-host disease of respiratory organs.
* Prognosis of BO is very poor, and the overall outcome of patients who are involved in BO is very dismal.
* The mechanism of BO has been known to be associated with immune / non-immune response.
* Corticosteroid and immunosuppressants are recommended as a best current treatment options for BO, which have been not satisfactory.
* Many treatment options have been tried to improve the outcome of BO.
* Azithromycin, as an immune modulating agent, has been tried for the treatment of BO, and has been reported to show hopeful results.
* N-acetylcystein, as an antioxidative agent, has been tried for BO.
* Inhaled corticosteroid may help to improve airway inflammation and decrease the amount of systemic corticosteroid.
* These 3 drugs are widely used for other respiratory disease, have been proven to be safe, and have shown some efficacy for BO in various depth of evidence.
* In these rationale, we'd like to try the 3-drug combination for BO, to assess the efficacy and safety of these drug combination.

Eligibility Criteria:
Inclusion Criteria:

* Patients who previously received allogeneic hematopoietic cell transplantation due to hematologic malignancy, bone marrow failure syndrome, and other compatible disease.
* Patients who are diagnosed as bronchiolitis obliterans (BO) according to the NIH diagnostic guideline which is suggested as below.
* Patients should be 15 years of age or older, but younger than 75 years.
* Patients should have estimated life expectancy of more than 3 months.
* Patients must have adequate hepatic function (bilirubin less than 3.0 ㎎/㎗, AST and ALT less than three times the upper normal limit).
* Patients must have adequate renal function (creatinine less than 2.0 ㎎/㎗).

Exclusion Criteria:

* Presence of significant active infection
* Presence of uncontrolled bleeding
* Any coexisting major illness or organ failure
* Patients with a psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible.
* Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
* Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
Neuroprotective Role of Erythropoietin in Perinatal Asphyxia

Whether Erythropoietin improves the neurological outcomes of neonates with perinatal asphyxia.

will be a randomized trial

Eligibility Criteria:
Inclusion Criteria:

* Babies with severe perinatal asphyxia with moderate to severe HIE in the immediate neonatal period

Exclusion Criteria:

* Babies with congenital malformations
* Small for gestational age babies
* Babies with chromosomal anomalies
Transient Elastography in the Determination of Advanced Fibrosis in Alcoholic Liver Disease.

Alcoholic liver disease is the most frequent complication of excessive alcohol consumption. Early diagnosis of alcoholic liver disease is essential to avoid its complications that could be fatal. To date, the reference diagnostic tool is an invasive procedure: the liver biopsy. The transient elastography is a useful tool for early diagnosis of liver fibrosis. This tool is validated in the diagnosis of liver fibrosis due to C chronic hepatitis. Because it is non-invasive, fast, given immediate results; transient elastography could be repeated in alcoholic patients for liver fibrosis follow-up. In the present study, the investigators propose to realize liver biopsy and transient elastography in 300 alcoholic patients in weaning to evaluate the transient elastography accuracy in the exclusion of sever liver fibrosis (Metavir 3 and 4). The reference liver fibrosis diagnosis tool will be the liver biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Patients more than 18 years old; hospitalised for alcoholic weaning; with an alcoholic liver disease; with at risk alcoholic consumption; with an indication of liver biopsy; with a signed consentment.

Exclusion Criteria:

* patients with a cirrhosis; with other causes of liver disease; with a contraindication of liver biopsy; having had a liver biopsy in the last 3 years; pregnancy; major benefiting from a legal protective measure; no coverage care.
Continuous Passive Motion Device for Children With Arthrogryposis

The Investigators are investigating a continuous passive motion device to exercise the knee of young children with arthrogryposis after they have had knee surgery.

The investigators will measure the effect of continuous passive motion (CPM) of the knee joint post-surgery on young children with arthrogryposis. The investigators have developed a motorized brace that will move the joint through a prescribed range of motion and speed while the subject is seated. The objective of this pilot study is to develop the device from subject feedback and determine the right dose and speed of CPM to provide. CPM is routinely used for adults and older children after surgery to maintain range of motion. The machines used are too large for young children therefore the investigators have developed a prototype for small sized kids that will exercise their knee joint post-surgery.

Eligibility Criteria:
Inclusion Criteria:

* Children with arthrogryposis
* Children between 3 and 7 years of age
* Children who have had recent knee surgery

Exclusion Criteria:

* Children older than 7
* Children unable to cooperate with protocol steps
Acute Effects of Caffeinated and Decaffeinated Coffee on Bioelectrical Impedance Analysis

This study investigates how caffeinated coffee, decaffeinated coffee, and water affect body composition, as measured by BIA. Participants were divided into three groups, consuming their respective beverages, with measurements taken over a 120-minute period. The study aimed to determine if caffeine or fluid intake is the primary driver of changes in body composition parameters.

This study aims to address these gaps by examining how caffeinated coffee, decaffeinated coffee, and water influence BIA measurements at multiple intervals post-consumption (baseline, 30, 60, 90, and 120 minutes). By incorporating a controlled study design with separate water-only and caffeine-free groups, this methodology overcomes the limitations of previous studies that lacked comprehensive control conditions. By determining whether caffeine or fluid volume primarily drives changes in BIA parameters and identifying the timing of these effects, this research seeks to improve the understanding of external factors affecting BIA, providing valuable insights for accurate body composition assessments.

Participants were divided into three groups based on their average daily caffeine consumption: caffeinated coffee, decaffeinated coffee, and water.

To standardize caffeine and fluid intake, filter coffee was chosen for its consistency in caffeine content and fluid volume. Both caffeinated and decaffeinated Arabic coffee were prepared using 11 g of coffee per 200 ml of water. The coffee was weighed using a precision balance and brewed with a filter coffee machine to ensure uniform preparation.

Participants were instructed to adhere to the following restrictions prior to the analysis day: a 12-hour fast, avoidance of excessive fluids, abstinence from caffeine-containing beverages, no showering or sauna use, no alcohol consumption for 48 hours, and no heavy exercise for 4-12 hours before the measurement. These restrictions minimized potential confounding effects on hydration or metabolic state, ensuring reliable BIA measurements.

The first BIA measurements were taken before any beverage consumption. Subsequently, participants consumed 200 ml of caffeinated coffee, decaffeinated coffee, or water, depending on their group. BIA measurements were repeated at 30, 60, 90, and 120 minutes post-consumption.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged ≥18 years.
* BMI between 18.5 and 29.9 kg/m².
* Regular coffee consumers.
* Participants providing written informed consent.

Exclusion Criteria:

* Individuals on medication or hormone therapy within the last 6 months.
* Medical conditions affecting caffeine metabolism (e.g., allergies or intolerances).
* Chronic or acute diseases.
* Significant appetite or eating disturbances in the past 6 months.
* Participants menstruating on the day of analysis.
Impact of Help-Seeking Behaviors on Allergic Rhinitis and Mental Health: A Longitudinal Study

This study explores how help-seeking behaviors for both emotional well-being and allergies impact the management of allergic rhinitis, asthma, and mental health symptoms, including anxiety and depression. The research involves a retrospective and longitudinal analysis of patients who sought treatment for allergic rhinitis and mental health concerns. The goal is to highlight the importance of integrating mental health care into allergy treatment plans to improve overall patient outcomes.

This study aims to investigate the impact of help-seeking behaviors (HSB) on allergic rhinitis (AR), asthma control, and mental health outcomes, such as anxiety and depression, using both retrospective and longitudinal data. The study examines patients who have been diagnosed with AR and mental health conditions to assess how seeking professional help for allergies, emotional well-being, or both influences symptom control and quality of life.

The research analyzes data from a diverse patient population to evaluate the effects of AR medications (intranasal steroids, antihistamines, decongestants, and leukotriene blockers) on both AR and mental health symptoms. Additionally, it explores the role of help-seeking behaviors in improving symptom management, specifically through the use of validated tools like the SNOT-22 for AR and the PHQ-GAD16 for mental health.

The study emphasizes the importance of integrating mental health screening and support into the treatment of allergic rhinitis and asthma. By analyzing real-world data, the research seeks to provide insights into how coordinated care approaches can enhance patient outcomes and inform future clinical practices.

Eligibility Criteria:
Inclusion Criteria:

Adults (aged 18 years or older) Patients actively receiving care in a primary care setting. Patients who have provided informed consent for their health data to be included in the research repository.

Exclusion Criteria:

Patients who have not provided informed consent for their health data to be included in the research repository.

Patients diagnosed with chronic conditions outside the scope of allergic rhinitis, asthma, or mental health conditions (anxiety, depression).

Patients with severe mental health disorders or comorbidities that are unrelated to the conditions of interest (e.g., schizophrenia, bipolar disorder, etc.).
Role of Pleural Fluid Attenuation Value on CT as a Diagnostic Tool in Traumatic Hemothorax

To define the potential role of pleural fluid attenuation value determined on computed tomography (CT) for diagnosis of traumatic hemothorax and differentiate it from other pleural effusion.

Hemothorax is defined as blood accumulation in the pleural space. It is a consequence of blunt trauma in 90% of cases. Hemothorax due to blunt trauma mechanisms e.g traffic accidents,sport accidents and falls are among the commonest injuries of the chest. It is manifested in 30-50% of chest trauma cases. In such cases, bleeding might be caused by damage to pulmonary parenchyma or intercostal arteries associated with or without rib fractures and other chest wall tissue injuries including parietal pleura or other thoracic structures. Although other pleural effusion types may also manifest such as chylothorax in case of chest trauma, however fluid detected in pleural space is usually considered blood unless proven not to be. Despite the clinical and radiological findings provide important data about the content of pleural cavity, however tube thoracostomy and diagnostic thoracocentesis are still required to relieve pressure and characterize the fluid. Tube thoracostomy is an invasive procedure which can lead to immediate procedural injuries, infections and pain which can contribute to respiratory failure in patients with chest wall injury. Although needle thoracocentesis is less invasive than tube thoracostomy, however it carries small but definitive risks such as pneumothorax, bleeding and chest wall hematoma. Since hemothorax is a potentially life threatening, it must be diagnosed quickly and accurately and all these unnecessary complications should be avoided. Chest computed tomography \[CT\] has been accepted as the gold standard imaging study for evaluating chest trauma and usually performed in patients with grossly severe chest trauma, as it helps to detect even small hemothorax.

CT can also allow for more advanced characterization of pleural fluid and distinguish hemothorax from any other types of effusion by means of scaling Hounsfield units as in literature, any attenuation value for pleural fluid between 35 and 70 HU is considered typically blood, so it can be considered as an important non-invasive diagnostic tool for diagnosis of hemothorax in traumatic patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients above 18 years old
* History of blunt chest trauma
* Having mild to moderate effusion
* CT chest within 1st 24 hours of trauma
* Patients underwent tube thoracostomy or thoracocentesis

Exclusion Criteria:

* Patients in need of emergency transfer to surgery.
* Hemodynamically stable.
* Patients with penetrating trauma.
* Patients with no need for tube thoracostomy or thoracocentesis.
* Patients with minimal effusion.
* Pregnant females.
Robson Classification of Indications of Cesarean Section at MUH

Robson classification of Cesarean section rates and indications allows evaluation and comparison of the contributors to the Cesarean section rate and their impact. It also allows comparison between institutions, regions, and countries that adopt this classification Robson's system classifies all deliveries into one of ten groups on the basis of five parameters: obstetric history (parity and previous cesarean section), onset of labor (spontaneous, induced, or cesarean section before onset of labor), fetal presentation or lie (cephalic, breech, or transverse), number of neonates, and gestational age (preterm or term; panel This study evaluates C.S rates and indications according to Robson classification in a University Hospital in a year (2016) to compare with international standards


Eligibility Criteria:
Inclusion Criteria:

* all cases who underwent CS at Mansoura University Hospital inpatients and emergency cases

Exclusion Criteria:

* non
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy

This is a randomized, double-blind, placebo-controlled, sequential, 5-day treatment, ascending dose study in subjects with obstructive HCM aged 18-70 years. The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women aged 18 to 70 years, inclusive at Screening
2. Has established diagnosis of HCM defined by standard criteria as a maximal left ventricular wall thickness ≥15 mm at initial diagnosis in the absence of other causative loading abnormalities capable of producing the magnitude of hypertrophy observed or ≥13 mm if the subject has a family history of HCM
3. Has LVOT gradient ≥30 mmHg at rest or LVOT gradient ≥50 mmHg with Valsalva maneuver, due to SAM

Exclusion Criteria:

1. Known infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics HCM, such as Fabry disease, amyloidosis or Noonan syndrome with LV hypertrophy
2. History of persistent atrial fibrillation prior to Screening or Baseline
3. History of paroxysmal atrial fibrillation requiring treatment (e.g., anti-coagulation and/or antiarrhythmic therapy) within 3 months prior to Screening
4. Recently treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation) within 6 months prior to Screening or plans to have either of these treatments during the study
5. Systolic heart failure with ejection fraction \<55% or heart failure symptoms of NYHA Class IV
6. QTcF \>480 msec at Screening or Baseline
7. Presence of diseases classified as significant by the Investigator at Screening or Baseline, including the following but not limited to:

   1. Diabetes mellitus requiring treatment
   2. Moderate or severe renal insufficiency or renal insufficiency with estimated glomerular filtration rate \<70 mL/min/1.73m2
8. Concomitant use of Disopyramide or Ranolazine within at least 7 days or 5 half-lives (whichever is longer) prior to Screening
Handheld Infrared Thermometer to Evaluate Cellulitis

It can be difficult to differentiate cellulitis from non-infectious mimics, like venous stasis. One way of determining the difference is feeling skin surface temperature. However, this is a subjective measure that is inherently unreliable. It might be possible to objectify this measurement by using a non-contact infrared thermometer at the bedside.

The goal of this study is therefore to assess whether objective difference in skin surface temperature in an area of suspected cellulitis, relative to non-affected skin, has diagnostic utility. It will use the diagnosis of cellulitis by an infectious diseases physician as the gold standard and compare blinded temperature difference between affected and unaffected limbs to that standard. It is hypothesized that measurement of skin surface temperature by non-contact infrared thermometer will help differentiate cellulitis from many non-infectious conditions that mimic cellulitis.

For patients who are hospitalized, the study also plans to see whether a change in this temperature difference is predictive of response to treatment when compared to the FDA standard for early response and patient reported symptoms.

This is a pragmatic, prospective cohort study. Patients with suspected cellulitis who receive an infectious diseases consult (in the emergency room or urgent clinic) will be approached for consent and enrollment. The goal is to enroll approximately 50 patients with a minimum of 10-15 cases of non-cellulitis.

These measurements will not be made available to the treating teams. This is an observational study only comparing the potential value of these measurements to usual clinical care.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older;
* English or French-speaking;
* Received an infectious diseases consultation to evaluate proven or suspected cellulitis of the upper or lower extremity, either unilaterally or bilaterally;
* Either no empiric antimicrobials received or, at most, antimicrobials begun within 24 hours of notification for enrollment.

Exclusion Criteria:

* Presumptive diagnosis of a soft tissue infection of the trunk, head or neck that does not also involve a limb;
* Patients with only one limb;
* Patients with significant neuropathies or autonomic syndromes that might affect thermoregulation, such as severe diabetic neuropathy or diabetic dysautonomia, neurologic neoplasms and known vitamin deficiencies;
* Soft tissue infections requiring definitive surgical source control, such as abscesses or necrotizing fasciitis.

  * Septic arthritis
Optimal Dosing of High-Intensity Locomotor Training for Step Attainment and Locomotor Outcomes in Stroke Patients Undergoing Acute Inpatient Rehabilitation

The purpose of this study is to elucidate optimal dosing for High Intensity Gait Training (HIGT) to reduce locomotor disability for those undergoing inpatient rehabilitation (IR) in the subacute phase of stroke recovery.

This is a randomized controlled trial conducted at a single IR facility. Investigators will randomize patients to receive one of two distinct HIGT interventions or a high step count intervention during standard care.


Eligibility Criteria:
Inclusion Criteria:

• Primary diagnosis of stroke

Exclusion Criteria:

* Weightbearing restrictions, uncontrolled cardiopulmonary, metabolic, infectious, or psychiatric disorders, which would preclude aerobic locomotor training
* Estimated length of stay of less than 14 days
* Non-ambulatory status prior to admission (unable to walk \>50 meters)
* Pregnant
Evaluating E2007 (Perampanel) in Patients With Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN)

The purpose of this study is to evaluate the safety, tolerability and continued efficacy of perampanel in patients previously enrolled in double-blind, placebo-controlled studies for Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN).


Eligibility Criteria:
Inclusion Criteria:

Each patient must meet all of the following criteria to be enrolled in this study:

1. Met and continues to meet all inclusion and none of the exclusion criteria for the preceding PDN or PHN study and received study drug or placebo under double-blind conditions.
2. Completed the preceding double-blind study End of Treatment (EOT) Visit no more than 12 weeks prior to Baseline (Visit 1) for the open-label study. The eligibility status of patients who do not enroll during this 12 week period will be evaluated on a case by case basis via discussion between the Investigator and the Sponsor.
3. Males and females ≥18 years of age. Female patients should be either of nonchildbearing potential as a result of surgery or menopause (1 year after onset), or of childbearing potential and practicing a medically acceptable method of contraception (e.g., abstinence, a barrier method plus spermicide, or intrauterine device \[IUD\]) for at least 1 month before the Baseline Visit (Visit 1) and for 1 month after the end of the study (Visit 16). They must also have a negative pregnancy test at Baseline (Visit 1). Female patients using hormonal contraceptives must also be using an additional approved method of contraception (e.g., a barrier method plus spermicide or IUD) throughout the study.
4. Provide written informed consent prior to entering the study and prior to undergoing any study-related procedures.
5. Is reliable, willing, and able to cooperate with the study procedures.

Exclusion Criteria:

Patients who meet the following criterion will be excluded from this study:

1. Patients who discontinued early for any reason from the preceding double-blind study.
2. Patients who have a clinically significant finding(s) that would make them unsuitable for the study in the opinion of the investigator or Sponsor.
TRANSCRIBE (Transcriptomic Analysis of Left Ventricular Gene Expression)

Hypothesis: The investigators hypothesize that genetic variants will alter gene expression in response to ischemia during cardiopulmonary bypass. To test this, the investigators will be taking small pieces of heart tissue from patients undergoing heart surgery before and after this period of ischemia. This will be compared to blood gene expression in blood cells and analyzed with the patients' genetic profile. This might allow us to assess the amount of inflammation that occurs when patients are on the heart-lung machine as well as examine the effects genes have on this critical time period.


Eligibility Criteria:
Inclusion Criteria:

* Aged greater than 20 years
* Undergoing aortic valve surgery with or without CABG surgery
* Receive and apical vent as part of the surgery

Exclusion Criteria:

* Will not receive an apical left ventricular vent