cyrilzakka/clinical-trials huggingface dataset:
Physical Activity, Motor Competence, Pulmonary Function, and Quality of Life in Children With Severe Spinal Disease

Observation study about physical activity, motor competence, pulmonary function, and health related quality of life in children, surgically treated for early onset scoliosis

Early Onset Scoliosis (EOS) defines patients who develop deformities of the spine and/or thorax in the embryologic development or in the early childhood. The exact prevalence of EOS in Norway is unknown, but it is assumed to be approximately 200-300 new EOS patients every year. EOS is a severe condition, whereby some of the most common and also most severe consequences of the deformity are severe pulmonary problems. The patients may require extensive orthopedic treatment from early childhood and until maturity to avoid serious consequences with severe pulmonary problems and shortening of life.

EOS' secondary problems, including severe consequences on the pulmonary function might contribute to enhanced inactivity. Inactivity contributes to further negative impact on development of the musculoskeletal system, motor competence and pulmonary function. Considering the severity of EOS and children's reduced life expectancy, it is extremely important that EOS children achieve the favorable impact of physical activity during their growth. Insufficient level of activity might worsen the prognosis, thus counteracting the treatment's ambitions. The investigator's aim is to extend the knowledge about level of activity, motor competence, pulmonary function, and health related quality of life in Norwegian children, surgically treated for EOS.

Eligibility Criteria:
Inclusion Criteria:

* Early onset scoliosis diagnosis
* Understand and speak Norwegian
* For physical activity test: Walking ability
* For motor competence test and/or pulmonary function test: Ability to understand the test and cooperate

Exclusion Criteria:

* Other spinal disease, not early onset scoliosis
The Role of OmniLenz® in the Treatment of Small Corneal Perforations Secondary to Exposure Keratitis in ICU Patients

Case series of 5 ICU patients in Farwaniya Hospital who developed exposure keratitis and a subsequent small corneal perforation between April 2022 and April 2024.

The investigators highlight the non-surgical role of OmniLenz® in the treatment of small corneal perforations secondary to exposure keratitis. The inclusion criteria were corneal perforation less than 1mm in size, positive culture \& sensitivity results and showing initial improvement on topical antibiotic eye drops.

The primary outcome measures were healing of the corneal perforation, a negative Seidel test and reformation of the anterior chamber.

Secondary outcome measures were improvement of all three of ciliary injection, state of epithelial defect, and corneal infiltration.

Eligibility Criteria:
Inclusion/Exclusion Criteria:

* Patients with small corneal perforations measuring \< 1 mm in diameter. Those with larger perforations (\>1mm) were excluded.
* Patients with conclusive results of keratitis (confirmed via culture and sensitivity scraping) AND showing improved keratitis following antibiotic treatment. Those with no confirmed keratitis through C\&S or with inconclusive scraping results were excluded.
* No age or gender restrictions were applied.
A Study of the Safety and Efficacy of Hylan G-F 20 (Synvisc) in Patients With Symptomatic Osteoarthritis of the Knee

This clinical study is to evaluate the safety and efficacy of hylan G-F 20 (Synvisc) in patients with symptomatic knee osteoarthritis (OA). Patients will be given 6 mL of hylan G-F 20 (Synvisc) (or a phosphate buffered saline control), with a possible repeat treatment with Synvisc after the week 26 visit.

The trial included an initial 26 week treatment with 6 mL of hylan G-F 20 (Synvisc) (or a phosphate buffered saline control) followed by a 4 week repeat treatment of Synvisc.

Eligibility Criteria:
Inclusion Criteria:

* Patient with documented diagnosis of primary osteoarthritis (OA) of the target knee made at least 3 months prior to Screening,
* Has radiographic evidence of OA in the tibio-femoral compartment of the target, knee with at least 1 definite osteophyte and a measureable joint space, as diagnosed by standard X-rays taken not longer than 3 months prior to Screening, and before any baseline assessment,
* Has continued target knee pain despite conservative treatment (e.g. weight reduction, physical therapy, analgesics),
* Has pain in the target knee as demonstrated by a score of 2 or 3 on the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale ,
* Has a mean score of 1.5 to 3.5 on the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale.
* Inclusion Criteria for Repeat Phase: Must have no major safety concerns during the first course of treatment as assessed by the Investigator; Must have a WOMAC LK 3.1 A score of at least 1.

Exclusion criteria:

* Has modified Kellgren-Lawrence Numerical Grading System of grade IV in the patello-femoral compartment of the target knee confirmed by standard X-rays taken not longer than 3 months prior to Screening, and before any baseline assessment,
* Has clinically apparent tense effusion of the target knee,
* Has had viscosupplementation in any joint including the target knee within 9 months prior to Screening,
* Has concomitant inflammatory disease or other condition that affects the joints (e.g. rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis and active infection, etc.,)
* Symptomatic OA of the contralateral knee or of either hip that is not responsive to paracetamol and requires other therapy,
* Has related hypersensitivities to avian proteins and/or any components of hyaluronan-based injection devices,
Thoracic Paravertebral Blockade in Video Assisted Thoracoscopic Surgery (VATS)

Video-assisted thoracoscopic surgeries (VATS) include severe postoperative acute pain which is also a predictor of chronic pain. In this study, the investigators aim to compare the postoperative effects of thoracic paravertebral block (TPVB) and intravenous patient controlled analgesia (PCA) on the prevention of chronic pain of patients undergoing VATS.

Video-assisted thoracoscopic surgeries (VATS) include significant postoperative acute and chronic pain because of trocar site tissue damages, intercostal nerve injuries and related inflammatory responses. Poorly controlled pain in the early postoperative period usually causes chronic pain, and also affects patients' physiotherapy, mobilization and daily function.

Our hypothesis in this study is 'thoracic paravertebral block (TPVB) is associated with an improvement in control of acute and chronic pain after VATS compared to systemic analgesia.

Eligibility Criteria:
Inclusion Criteria:

ASA I-III Patients who undergo Video-assisted thoracoscopic surgery (VATS) under GA

Exclusion Criteria:

Patients with difficult understanding the instructions for using PCA and/or pain scales Patients with contraindication to regional anesthesia Patients with significant neurologic, psychiatric or cognitive disorders History of substance abuse or chronic opioid use
Diagnostic Evaluation of Out-of-hospital High-sensitivity Troponin I in Patients Presenting Chest Pain

Conducting an analysis of the clinical performance of high-sensitivity cardiac troponin I, tested in the out-of-hospital setting, for ruling out cardiac origin in acute onset chest pain.

Acute onset chest pain is a complex symptom to narrow down in the out-of-hospital setting. This is due to the difficulty of obtaining pertinent information over the phone, and the absence of validated dispatch scores or criteria.

In France, the current standard of care relies on the rapid dispatch of Emergency Medical Response Teams along with a physician in patients presenting symptoms evocative of Coronary Artery Disease or Myocardial Infarction.

Typical anginal pain includes retrosternal pressure pain radiating to the jaw, neck, or left arm. Diagnostic work-up includes anamnesis, physical examination, routine blood work, and ECG.

In the absence of signification ST-segment modifications, the gold standard relies on trending serum Troponin T and I in the hospital setting .

This study aims to analyze the clinical performance of high-sensitivity cardiac Troponin I assays (hs-cTnI) in the out-of-hospital setting using a point-of-care device ; Atellica VTLi (Siemens Healthineers)


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Presenting with evocative acute onset chest pain

Exclusion Criteria:

* ECG modifications with ST segment elevations
* Patients for whom anginal origin was excluded in the out-of-hospital setting
* Medical evaluation in a delay inferior to 20 minutes
* Patients without medical insurance
* Pregnant or lactating women
* Patients under reinforced guardianship, minors, patients in hospice care
Effects of Ligands on Human Hair Follicles Grafted Onto SCID Mice

The purpose of this study is to determine if immunophilin ligands may have the potential to reverse hair loss.

Preliminary experiments in C57BL/6J mice showed that immunophilin ligand FK506 and its non-immunosuppressive analogs, GP11046 and GP11511 were capable of promoting telogen to anagen transition. Since GP11046 and GP11511 possess the neurotrophic properties of FK506 without its immunosuppressant capability, the neural action of these immunophilin ligands may play an important role in the hair cycle. This finding has significant clinical implications in that immunophilin ligands may have the potential to reverse alopecia. To further investigate this possibility we propose to explore the response of transplanted miniaturized scalp hair follicles to topically applied immunophilin ligands.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men ages 18-65 with Hamilton type IV or V alopecia

Exclusion Criteria:

* Individuals who do not meet the inclusion criteria.
Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation

The occurrence of bronchiolitis obliterans syndrome (SBO) after allogeneic hematopoietic stem cell transplantation (HSCT) is considered to be a chronic pulmonary graft versus host disease (GVHD) that is associated with significant mortality and morbidity. The reported incidence of SBO varies from 6 to 26% of allogeneic HSC recipients and is usually diagnosed within 2 years after transplantation. The diagnosis of SBO relies on the occurrence of a new airflow obstruction identified during pulmonary function testing, and the definition differs between studies. Currently, no curative immunosuppressive treatment is available, and recent data suggest that the use of these treatments, especially corticosteroids, should be limited because of their toxicity. The impairment of lung function parameters is likely caused by fibrous small airway lesions. Few data on the pathogenesis of SBO after allogeneic HSCT are available. Several hypotheses are based on the occurrence of SBO during chronic graft rejection after lung transplantation, which shares many clinical and histopathological similarities with SBO after allogeneic HSCT. One hypothesis is that the first step leading to SBO is lung epithelium injury. SBO is then identified as an alloimmune reaction with only one clearly identified risk factor: extrathoracic chronic GVHD. Due to their anti-inflammatory and immunomodulatory properties, recent data suggest that low-dose macrolides may be effective at preventing SBO after lung transplants. This well-tolerated treatment may be useful for preventing SBO after allogeneic HSCT.

The objective of this Phase 3 multicentre randomized, double-blinded, clinical trial is to evaluate the efficacy of azithromycin in preventing BO syndrome after allogeneic HSCT in patients with malignant hematological diseases.


Eligibility Criteria:
Inclusion Criteria:

* Patients\> 16 years old
* Experimenting an allogeneic HSCT for a hematologic malignancy
* Pre-transplantation Pulmonary Function Testing
* With written informed consent

Exclusion Criteria:

* Allergy or Intolerance to azithromycin, macrolides or ketolide or excipient
* Prolonged corrected QT (QTc) interval (\>450 msec)
* Taking medications that prolong the QTc interval (Cisapride, ergotamine, dyhydroergotamine)
* Taking ergotamine and dyhydroergotamine due to the risk of ergotism
* Family history of a prolonged QTc interval.
* History of congestive heart failure
* Taking colchicine Severe liver insufficiency • History of infection due to atypical mycobacteria
An 8 Week Study Of Depression In Adults Diagnosed With Major Depressive Disorder

A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in Patients with Major Depressive Disorder (MDD)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Major Depressive Disorder (MDD)
* Duration of current depressive episode 12 weeks - 24 months
* Patients can read and write at a level sufficient to provide a signed consent
* If female, patients must be practicing an acceptable method of birth control

Exclusion Criteria:

* Patients have other psychiatric disorders that would affect patient's response to treatment
* Patients have not responded to two or more adequate courses of antidepressant therapy
* Patients cannot be currently abusing illicit drugs or alcohol
* Patients are not currently receiving psychotherapy
* Patients have received electroconvulsive therapy within 6 months prior to screening
* Patients are pregnant or lactating
Investigation of Immune Disorders and Deficiencies

The immune system is an intricate system comprised of specialized cells, proteins, tissues and organs. Proper functioning is critical to the body's ability to defend itself against harmful pathogens. Immunological disorders and deficiencies are defects in the immune system that lead to abnormal immune responses. Abnormal immune responses could be derived from immune deficiencies, dysregulations or hypersensitivities.

The overall goal of this research study is to identify the mechanisms of primary immune deficiencies and immune disorders at the genetic, cellular and molecular level, using novel analytic techniques to be performed on immune cells derived from blood samples. The knowledge gained from the aims of this study could lead to better diagnostics and identify novel targets for therapeutic interventions.

Primary immunodeficiency diseases (PID) represent a class of disorders in which there is an instrinsic defect in the human immune system. The PID could be caused by defects or perturbations in either the innate or adaptive immune cells, such as B cell defects which result in lack of antibodies. Research in this topic remains a difficult feat due factors such as genetic heterogeneity and the gene-environment interface. Limitations of standard of care testing leads to many patients with immunological problems to be undiagnosed. In addition to the variety of primary immune deficiencies, there are large number of immune system disorders due to various perturbations in the immunological components that cause diseases with much greater prevalence such as autoimmune diseases, lymphoproliferative diseases, chronic inflammation and certain cancers. The causes of these immune disorders are typically more complex than PID but there are also many overlaps in immune hyper-activation and deficiency.

Eligibility Criteria:
Inclusion Criteria:

* Subject is greater than or equal to 1 day of age and less than or equal to 100years of age
* Signed Informed Consent/Assent
* Subject is able and willing to comply with study protocol requirements
* From clinical or blood laboratory findings subject has evidence of immune abnormalities (or no immune abnormalities in the case of controls) or immune-mediated disease.

Exclusion Criteria:

* Risk factors for donating blood (such as anemia or blood clotting disorders)
Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)

Background:

- Computed Tomography (CT) is a scan that makes detailed pictures of the body. It uses radiation to do that. In 2011, about 85.3 million CT scans were done in the United States. But there is growing concern about the health effects of radiation. There are new and different ways to make CT pictures that use less radiation. Researchers want to learn whether these new methods create images that are similar to images from a traditional CT.

Objective:

- To learn if new CT imaging methods with less radiation make images that are similar to traditional ways.

Eligibility:

- Adults 18 years of age and older who are scheduled for a CT of the chest, abdomen and pelvis with contrast.

Design:

* Researchers will review participants medical records to see if they can be in this study.
* Participants may have blood drawn from an arm vein by a needle stick. The blood will be used to make sure they can be in this study and that it is safe for them to have contrast.
* During the participants CT scan appointment, one extra scan will be done using low radiation methods.
* During a CT scan, the participant lies on a table. A large x-ray machine takes pictures of the body.

Computed Tomography uses ionizing radiation to make pictures of the body. Different methods of creating CT pictures have been developed that allow reductions in the amount of radiation. The purpose of this research study is to learn whether these new imaging methods using less radiation to create images are similar to the traditional and current method.

Eligibility Criteria:
* INCLUSION CRITERIA:

Inclusion Criteria for Body CT:

1. Clinical indication for a chest, abdomen and pelvis CT with contrast
2. Age equal to or greater than 18 years
3. Able to understand and willing to sign the Informed Consent Form

Inclusion Criteria for Chest CT:

1. Clinical indication for a CT with or without contrast that includes the chest
2. Age equal to or greater than 18 years
3. Able to understand and willing to sign the Informed Consent Form

EXCLUSION CRITERIA:

Exclusion Criteria for Body CT:

1. Pregnancy
2. Serum Cr \> 1.5 mg/dL
3. Clinical CT scan with more than one contrast imaging phase (for example three phase liver)

Exclusion Criteria for Chest CT

1. Pregnancy
Perioperative SDD to Prevent Infectious Complications After Esophagectomy

The primary aim of the PERSuaDER-trial is to evaluate the effect of SDD on infectious complications after esophagectomy, focussed on the prevention of pneumonia

Esophagectomy is a complex surgical procedure, associated with significant morbidity and mortality rates. Most postoperative complications are caused by infections (10-30%). These are thought to arise from (micro-)aspiration of bacteria residing in the oropharyngeal and gastrointestinal (GI) tract, leading to (respiratory) infections. Selective decontamination of the digestive tract (SDD) is a prophylactic antibiotic strategy that aims to prevent postoperative infections. Pathogenic aerobic gram-negative rods and yeasts tract are reduced, while anaerobic, protective microbiota are preserved. SDD has been shown to lower the risk for respiratory infections in an intensive care setting. Establishing SDD as effective addition to the standard care of esophagectomy patients is expected to increase their chance of survival.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary esophageal adenocarcinoma or squamous cell carcinoma (cT1b-4a,N0-3,M0) in the mid or distal esophagus or at the level of the gastro-esophageal junction scheduled for undergoing transthoracic esophagectomy with curative intent or for esophageal reconstruction with a gastric or jejunal interposition
* Age ≥ 18 years,
* Able to give written informed consent.

Exclusion Criteria:

* Patients planned for rescue surgery,
* Patients planned for colonic interposition,
* Known or suspected pregnancy,
* Patients who have undergone upper GI surgery within 30 days before randomization,
* Unable to understand the study information, study instructions and give informed consent.
* Patients enrolled in a trial that would interact with the intervention
* Patients with a known allergy, sensitivity, or interaction to investigational medicinal product.
* Patients with known/documented colonization of Enterobacteriaceae and or Pseudomonas Aeruginosa that are resistant to both tobramycin/gentamicin and to carbapenem antibiotics
* Patients undergoing CVVH.
* Patients with documented chronic renal failure (GFR \< 15 mls/min) or who are on chronic intermittent hemo- or peritoneal dialysis,
* Women of childbearing potential at risk of pregnancy, not using adequate contraception,
* Patients with the inability to swallow the SDD
* Patients with pre-existing degenerative neuromuscular diseases like, but not limited to, myasthenia gravis or Parkinson disease).
Relationship Between Trunk Control and Hand Function and Quality of Life

Increasing quality of life and improving hand functions are very substantial treatment goals for physiotherapy and rehabilitation. Trunk control is important for these parameters in children with hemiparetic and diparetic Cerebral Palsy.

Trunk control, hanf function and quality of life measurements were carried out by a physiotherapist using the Trunk Control Measurement Scale, 9-Hole Peg Test and Pediatric Quality of Life Inventory. Participants were informed about the procedure of the tests. The evaluation period lasted 30-40 minutes for each child.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 5-18,
* Having a diagnosis of hemiparetic or diparetic CP,
* To be at the level of I-II-III according to the Gross Motor Function Classification System,
* Not having had orthopedic surgery on the upper extremity in the last 6 months,
* Not having been injected with Botulinum Toxin-A in the last 6 months,
* Accepting the study and signing the consent form.

Exclusion Criteria:

* Children who could not understand and follow simple verbal commands,
* Did not meet the inclusion criteria,
* Incomplete assessments.